US20130019374A1 - Gel-based seals and fixation devices and associated systems and methods - Google Patents

Abstract

Gel and non-gel structures for interfacing with various portions of an organism's body are disclosed. A gel structure such as a web-like structure is configured to encircle a portion of the human body. The gel structure can be adapted to encircle virtually any exterior or interior portion of the human body. The gel structure can interface with an external medical device for delivery of medicine or for extracting substances and fluids from the human body.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Patent Application No. 61/429,687, filed Jan. 4, 2011, U.S. Provisional Patent Application No. 61/429,693, filed Jan. 4, 2011, U.S. Provisional Patent Application No. 61/475,469, filed Apr. 14, 2011, U.S. Provisional Patent Application No. 61/475,489, filed Apr. 14, 2011, and U.S. Provisional Patent Application No. 61/475,530, filed Apr. 14, 2011, all of which are incorporated herein by reference in their entireties.
FIELD OF THE INVENTION
• The field of the invention is pliable and resilient gelatinous elastomer seals for isolation of a user's skin from external or internal environments.
BACKGROUND
• Sealing and cushion pads made of a compliant and resiliently deformable gelatinous elastomer suitable to conform under pressure to form a substantially airtight or watertight seal with a least a portion of a user's skin adjacent to the sealing pad are disclosed in U.S. Pat. No. 6,152,137, issued Nov. 28, 2000, which is a continuation-in-part of application Ser. No. 08/794,154, now U.S. Pat. No. 6,098,205, issued Aug. 8, 2000, which is a continuation of application Ser. No. 08/377,257, Jan. 23, 1995, abandoned. The disclosure of these patents is hereby incorporated herein by reference in their entireties.
• Many medical devices are equipped to attach to or append from the human body. However, most devices are uncomfortable to wear for extended periods or in sensitive areas of the body. Also, many devices are unable to properly seal to the human body without applying excessive pressure to the skin which can be uncomfortable and in the worst cases can irritate or deteriorate the skin. There is a need for a device that can be fixed to various portions of the human body with a proper seal and without causing discomfort.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a sagital view of theusers skin1 and asealing pad2 with a skin covering3, which is interposed between the user'sskin1 and thesealing pad2 and which uses at least oneflange4.
• FIG. 2 is a frontal view of asealing pad2 with a skin coveringmaterial3, in which theflanges4 can include varying shapes and sizes andthicknesses94 andthickness95 or elasticity.
• FIG. 3 is a sagital view of asealing pad2 andskin covering material3, which can include one or more than oneflange4 that can be on the surface away from theskin1 to serve as a wall or barrier and can deflect5 solids or liquids or gases to include inhaled or exhalesgases6.
• FIG. 4 is a front view of asealing pad2 withflanges4 and a skin coveringmaterial3 which can be coated or impregnated with a substance or medication.
• FIG. 5 is a sagital view of asealing pad2 withflanges4 and a skin coveringmaterial3, in which theflanges4 can be stacked or constructed to form a geometric shape that can have volume and can create a network and can include a pyramid, a hexagon, a pentagon, a cylinder, or a box or a honey-comb-like configuration.
• FIG. 6 is a front view of asealing pad2 with a skin coveringmaterial3 with a fixation method.
• FIG. 7 is a front view of afixation method11 that can include a gel that can include a pattern to include linear, curvilinear, crossing, criss-crossing, intersecting, and non-intersecting and non-criss-crossing or a weave or any combination of these methods and the pattern can include alternating regions ofsealing pad2 and the absence ofsealing pad2 can be referred to as a web or web-like pattern.
• FIG. 8 is a front view of afixation method11 used with a condom catheter13.
• FIG. 9 is a frontal view in which the fixation method can be used with a garment and the fixation pattern.
• FIG. 10 is a frontal view in which the fixation device can include a fixation device that can be used with asealing pad2 or asealing pad2 and a skin coveringmaterial3, which can be an interface between a livingorganism body part8 and a non-living object.
• FIG. 11 is a sagital view of a molded or geometric shape formed sealingpad2, which can be gel or non-gel but in the preferred embodiment is agel sealing pad2. Thegel sealing pad2 can be folded upon itself so that the outer or external layer orlayers25 of the sealingpad2 compresses theinternal layer26 to form a self-sealing external compressive force.
• FIG. 12 is a series of views ofsealing pads2, which can be composed of one of more projections or folds that can be configured similar to the shape of the letter ‘E’ or ‘W’ or ‘N’ or ‘M’ or ‘C or ‘S’ or any combination of these shapes such that insinuation of thesealing pad2 and the skin coveringmaterial3 to form an airtight and watertight seal between theskin1 and thesealing pad2 and the skin coveringmaterial3.
• FIG. 13 A is a frontal view andFIG. 13 B is a sagital view of a folded or moldedgel sealing pad2 can be used to hold a skin coveringmaterial3 in place, and form a seal with at least a portion of theskin1 and, forms a barrier to include inhaled or exhaledgas6 and in one embodiment this can include abreathing mask2.
• FIGS. 14 A and B depicts a sagital view of a device for securing a sealingpad2 and securing a sealingpad2 and a skin coveringmaterial3.
• FIG. 15 is a sagital view of theskin1 and agel sealing pad2 that is configured as a folded or molded30 configuration in which the there is a single skin coveringmaterial3 that has abulbous component14 that can include the edge of the skin coveringmaterial3 and thebulbous component35 of the skin coveringmaterial3 is compressed bycompressive forces27 created from the surroundedsealing pad2 which can include a folded or molded30gel sealing pad2 such that the skin coveringmaterial3 is secured and constitutes a securedskin covering attachment28.
• FIG. 16 is a sagital view of theskin1, asealing pad2 andskin covering material3 which can include multiple layers and combinations ofprotuberances32 andinvaginations31, which can include one or more than oneprotuberance32 andinvagination31 or can be a combination of one or more protuberances and invaginations or a series ofprotuberances32 andinvaginations31.
• FIG. 17 is a sagital view of an anchoring device that is used in conjunction with asealing pad2 and a skin coveringmaterial3 to form a female urinary diversion system or condom catheter.
• FIG. 18 is a sagital view and depicts aurinary collection device23 which can include are one or more than oneorifice8,37anchoring devices35 and can be placed into and include the anus and the vagina.
• FIG. 19 is a sagital view of a maleurinary collection device23 orcondom catheter15
• In which theanchoring orifice device35 can be the anus and amale condom catheter15 can be attached to theanchoring device35.
• FIG. 20 is a sagital view of acontraceptive device23 which can include one or more than oneorifice8,37anchoring devices35 and can includeorifices8,37 to include the anus and the vagina.
• FIG. 21 A is a sagital view of anostomy8sealing pad2 andskin covering material3.
• FIG. 22 is a sagital view of asealing pad2 with overlapping ends and depicts how thesealing pad2 orskin covering material3 or thefixation device11 or the combination of thesealing pad2 and the skin coveringmaterial3 and thefixation device11 can be joined together using closure methods anddevices7 to include Zip locks, Velcro, pins or pegs, thread, ties, hooks, zippers, adhesives, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlockingdevices23.
• FIG. 23 is a sagital view of adevice23, which uses ananchoring device35 that is formed by anchoring theanchoring device35 to abody part8 which can include a tooth or the teeth.
• FIG. 24 is a sagital view of adevice23, which uses ananchoring device35 that is formed by anchoring theanchoring device35 by a means to include anchoring theanchoring device35 using at least one brace or tooth appliance.
• FIG. 25 is a sagital view of adevice23, which uses ananchoring device35 that can restrict movements of structures to include tongue movement posteriorly for preventing sleep apnea.
• FIG. 26 is a frontal view of anostomy fixation device11 that can be used with agarment20 or a material.
• FIG. 27 is a breathing mask or ventilation orintubation device23 which can use agel sealing pad2 or asealing pad2 with a skin coveringmaterial3 in conjunction with a liquid solution or a solid material or a gas or a mixture of these substances as an exchange material that can facilitate the organism gas exchange of substances such as oxygen or carbon dioxide.
• FIG. 28 is a frontal view that depicts the isolation of abody part8 on the external portion of the body or the internal portion of the body to include a cavity or within a cavity or within thebody8 or within a hollow viscous organ.
• FIG. 29 is a frontal view that can consist sealingpad2 andskin covering material3 that can be utilized to include a cast or bandage or wound56cover3 that can contain areservoir41 or one ormore conduits16 for delivery or removal of substances containing a solid or liquid or gel or gas that can include a therapeutic, pleasurable, moisturizing, humidifying or drying, heating or cooling, anti-itching substance or medication.
• FIG. 30 is a frontal view that depicts areservoir41 that can be a compressive device and can contain a solid, liquid or gel or gas or a combination of these elements that can adjust theairtight sealing pad2 in situations that require greater forces.
• FIG. 31 is a frontal view of a condom which is a skin covering3. The condom63 can include a skin coveringmaterial3 or a skin coveringmaterial3 and asealing pad2 or a combination of these elements. Thesealing pad2 and skin covering3 can have anindicator54.
• FIG. 32 is a frontal view of an isolation chamber, which include asealing pad2 and skin covering3 orfixation device11 or ananchoring device35 andflanges4 or one or more additional chamber or device.
• FIG. 33 is a sagital view of a female urinary retention anddiversion device23 that in the preferred embodiment there can be a combination of asealing pad2, a skin coveringmaterial3, ananchoring device35 that can include ananal anchor68 or a vaginal69 anchor, afixation device11, anindicator54 or afeedback device42 or astimulating device70 or any combination of these elements can be used with a condom catheter or micurition device and can be used to include train or affect or improve urinary urethral65 andpelvic floor muscle67 function to include indicators which are sensing54 andfeedback42 and stimulating70 and can include neuro-musculature stimulating70 electrodes and sensing42 units for micturition and urination control.
• FIG. 34 is a sagital view of asealing pad2 and a skin coveringmaterial3 that containsindicators54 andfeedback devices42 that can used being used as a breathing mask.
• FIG. 35 is a frontal view of anindicator54 or measuringdevice54 and afeedback device42.
• FIG. 36 is a sagital depiction of a device to capture and then simulate breastfeeding and then simulate that sensation in a breast-pumping orbreastfeeding device23.
• FIG. 37 is a close-up frontal view of thesealing pad2 of the breast pump seal or stimulating device.
• FIG. 38 is a frontal depiction of a communication device
• FIG. 39 is a sagital depiction of a nose plug sealing pad.
• FIG. 40 A is a frontal view and40 B is a sagital view of a low profile flexible swimming goggle.
• FIG. 41 is a close up top view of thesealing pad2 and the skin coveringmaterial3 that can include a goggle oreye92 protection that can be airtight and watertight or non-airtight and watertight and can be gel or non-gel.
• FIG. 42 is a frontal view of aneyepiece90 that displays98 or projects a sensory signal.
• FIG. 43 is a frontal view of an eye-viewing device100 that can be used with amedical device23 that traditionally has a screen such that the user has to turn their neck orbody8.
• FIG. 44 is sagital depiction of a sealing pad that containsinclusions101 that can include an ear plug.
• FIG. 45 is a sagital depiction of asealing pad2 or asealing pad2 and a skin coveringmaterial3 that can include an ear plug which can be composed of a gel or a non-gel material and which can contain conduits orchannels16 through at least a portion of thesealing pad2 which in the preferred embodiment is anearplug102.
• FIG. 46 is a sagital depiction of asealing pad2 or agel sealing pad2 and askin covering material3 or afixation device11 or any combination of these elements that protects breast tissue that can be use for the purpose of tender breasts and nipples during maternal-infant breast feeding, after surgery, during or after chemotherapy or radiation therapy, during or after learning how to wear a bra, after trauma, or injury, alter sensation for comfort or pleasure.
• FIG. 47 is a sagital depiction of askin covering material3 that can have a smaller circumference at one end than another end to be used with asealing pad2.
• FIG. 48 is a frontal view of a nasal device that can be used to open the nares and nasal passages.
• FIGS. 49 A and B are a frontal and a sagital depiction of a nasal device that can be used to open the nares and nasal passages.
• FIGS. 50 A and B is a frontal view of askin covering material3 that forms a wound closure device and method. In the preferred embodiment the skin covering material wound strips.
• FIG. 51 is a frontal view of an applicator or expander that can be placed within asealing pad2 to assist in the application of thesealing pad2 onto a body part.
• FIG. 52 is a sagital view of a device to deliver medication through the skin to a subdermal or subcutaneous structure.
• FIG. 53 is a sagital view of agel sealing pad2 with a method for altering itsphysical properties124 to include the hardness andsoftness94 andthickness95 of thesealing pad2.
• FIG. 54 is a frontal view ofcondom127 that can alter its physical characteristics.
• FIG. 55 is a sagital depiction of an exoskeleton that can be composed a material to include a gel or solid that has the ability to alter its physical properties.
• FIG. 56 is a sagital depiction of an endoskeleton that can be composed a material to include a get or solid that has the ability to alter itsphysical properties124.
• FIG. 57 is a head cooling device that can be worn over the head whose use is to treatbody8 to include brain or biologic or physiologic conditions.
• FIG. 58 is a head cooling device that can be worn over the head whose use is to treatbody8 to include brain or biologic or physiologic conditions.
• FIG. 59 is a sagital depiction of acast138 that has agel undercoat136 orgel roll135 between thecast138 and the user'sskin1.
• FIG. 60 is a sagital depiction of askin covering material3 which can include being used as a contraceptive or condom or condom-like or infection prevention device that can be used by both a male or female condom that has a state altering substance.
• FIG. 61 is a frontal view of an occlusive device that utilizes a substance that can undergo astate change141 and can be used in a living organism to include a the female reproductive system to occlude thefallopian tubes143.
• FIG. 62 is a frontal view of a cap150-like device150 and method to occlude the female reproductive system at theopening163 of theuterus142 and thefallopian tubes143 and a method to the keep in place ascaffold144 or thestate altering substances141 or asealing pad2 or a more permanent agent or acement145 orsclerosing agent145, or a device can be held in place.
• FIG. 63 is sagital view of a vessel substitute or stent151-like device151 can be composed of ascaffold144 that can include ascaffold144 that can be non-resorbable or at least partially resorbable.
• FIGS. 64A and 64B are a sagital views of a multi-hole152,153catheter147 withside holes152 that can vary in size and shape that can be used to deliver substances in a differential fashion. In one embodiment the side holes152 are larger at the proximal155 end of thecatheter147 than at the distal end of thecatheter147.
• FIGS. 65A,65B, and65C are sagital views of a method for folding a sealing pad to create an airtight and watertight seal with the user's skin using a cast covering skin covering material andFIG. 65D is an embodiment of the cast cover in its final positioning with the sealing pad and the skin covering in place.
• FIGS. 66A and 66B are fixations methods and devices that can include but are not restricted to include a lattice or web or integral or interconnected strands with overlapping that are used with a condom catheter.
• FIGS. 67A and 67B are sagital views of an embodiment of a method and a device to increase the coefficient of friction in thesealing pad2.
DETAILED DESCRIPTION
• Included herein at embodiments described for various unique applications of pliable and resilient gelatinous elastomer seals for isolation of a user's skin from external or internal environments. As used herein, the gelatinous elastomer seals are referred to as seals or pads or cushions. The pads may be used to form airtight or watertight seals or to provide cushions or covering, or both. The pads of the present invention conform to the numerous variations in topography of the user's skin, and when used as sealing pads distribute the compressive force throughout the pad to form an airtight or watertight seal with less pressure or compressive force that is required for solid or semisolid materials. As a result, the otherwise prominent surface characteristics of the user to which the pad is applied do not become pressure points since the pressure necessarily to form the airtight or watertight seal is more evenly distributed. This in turn has the potential to pad. The seals can be made of a gel or a non-gel material. In another embodiment the sealing pad can be non-resiliently deformable.
• The described applications of the gelatinous elastomer seals may be used in a wide variety of situations to isolate the skin itself or to isolate an orifice such as the user's ears, eyes, nose, mouth, rectum or vagina. Skin refers to all membranes, mucosa and body cavity linings to include fascia, the peritoneal cavity lining, respiratory and oral and digestive cavity linings to include the stomach, bowel, intestines, uterus. ureters, bladder, rectum, anus, mouth, and nose. Other body cavities and linings can include the uterus, fallopian tubes, bladder, trachea, bronchi, meninges of the brain and spinal, the orbit and the ear and its related structures. Such isolation may need to be airtight or watertight, and such terms are used interchangeably herein.
• The described applications of the gelatinous elastomer seals may be used in a wide variety of situations to isolate the skin itself or to isolate an orifice such as the user's ears, eyes, nose, mouth, rectum or vagina. Skin refers to all membranes, mucosa and body cavity linings to include fascia, the peritoneal cavity lining, respiratory and oral and digestive cavity linings to include the stomach, bowel, intestines, uterus. ureters, bladder, rectum, anus, mouth, and nose. Other body cavities and linings can include the uterus, fallopian tubes, bladder, trachea, bronchi, meninges of the brain and spinal, the orbit and the ear and its related structures. Such isolation may need to be airtight or watertight, and such terms are used interchangeably herein.
• The description of various aspects of the invention included herein are given to explain certain features of the various devices and methods of the present invention. The examples given herein are for purposes of explanation and not limitation. Various devices are described herein, and it is to be appreciated that some of these devices have an accompanying method of use or manufacture, and that these associated methods are part of the disclosure. Similarly, where a method is described, the invention may include the corresponding device where applicable.
• The gelatinous elastomer pad may be used as a cushion or seal or pad and covering material that is used for breathing mask. The breathing mask can be used for a continuous airway pressure (CPAP) mask and non-continuous positive airway pressure or alternating degrees of positive airway pressure or negative airway pressure or basic gas exchange. The breathing mask can be used for an environment protection mask, isolation mask, surgical mask, anesthesia and gas delivery mask, scuba and liquid submergence mask, a scent and smell delivery mask, a gas exchange mask, a fluid exchange mask that can be used for liquid delivery that facilitates ventilation, a pressure exchange mask, a pressure equalization mask, a cardio-pulmonary resuscitation (CPR) mask and a respiratory ventilation assistance mask to include active and/or passive assisted pulmonary ventilation. The sealing pad and the related devices and augmentations can be used with the sealing pad can be used for intubations. The seal of the mask in the preferred embodiment is composed of gel, which can create an airtight and watertight seal. The gelatinous elastomer pad may be used alone or in conjunction with non-gel materials and the pad can be a non-gel material or a combination of gel and non-gel material. The sealing pad can be perforated and connect to an external CPAP or respiratory or breathing machine or to exchange air or liquids or solids. The seals can include gels, Thermo Plastic Elastomers that can include Cyberskin, Silicon, Polystyrenes, Polystyrene and oil mixtures, and latex rubbers to include jelly rubber. The sealing pads disclosed herein can include microfiber materials or any other suitable materials having desirable characteristics, such as high or low friction, elasticity, etc.
• A sealing pad can form a substantially airtight seal between a skin covering material and at least a portion of the user's skin. The sealing pad can be a compliant and resiliently deformable annular gelatinous elastomer suitable to conform under pressure to form a substantially airtight seal between the skin covering material and at least a portion of the user's skin. A gel can include a gelatinous elastomer suitable to conform under pressure to form a substantially airtight or watertight seal and at least a portion of the user's skin. A gel sealing pad can include a gelatinous elastomer suitable to conform under pressure to form a substantially airtight or watertight seal with at least a portion of the user's skin. A gel sealing pad and skin covering can include a gelatinous elastomer suitable to confirm under pressure to form a substantially airtight or watertight seal between the skin covering material and at least a portion of the user's skin. In another embodiment the sealing pad can be non-resiliently deformable.
• In the preferred embodiment the mask would utilize flexible materials for the frame and attachment and covering materials and membranes. Other embodiments could include hardened material for the frame but these would be positioned to minimize discomfort to the user.
• The sealing pad may be affixed to an outer or inner covering membrane or material. In one embodiment the fixation can be through integration of the gel into the material or through an adhesive material. The sealing pad may be separate or detachable from the outer or inner membrane or frame so that it can be replaceable. The skin covering material can be flexible or semi-flexible or not flexible.
• The sealing pad may be composed of projections that can vary in shape and serve as flanges or valves that form an airtight or watertight seal with the skin. The sealing pad may be composed of projections that can vary in shape and serve as flanges that serve to separate the skin from the pad or covering material. The projections can be geometric or non-geometric. The projections can form an airtight seal in some sections and be non airtight in others allowing for breathability of the skin. The projections can be constructed to follow or adjust to the contours of a body part. The body part can be superficial or can be internal. It can be in a cavity or organ. It can be on the skin, within the skin layers or deep to the skin within the organism.
• The seal can be annular or the seal can be non-annular. The seal can be composed of a series of circumferential valves/flanges/slats that can be composed of a material that can include a gel but can be made of a material that is not a gel or a combination of a gel and a non-gel.
• In the preferred embodiment the gel seal can be composed of a series of circumferential flanges or slats that can be composed of a material that is a gel. The flanges can be all oriented in the same direction or in opposing directions. The flanges can be one row or multiple rows. The flanges can be oriented to create a variable pattern that can create a watertight seal and can better conform to the user's skin contours. The flanges can be created such that the flange composed of gel or non-gel has an endoskeleton. The seal can be one or more continuous pieces or non-continuous pieces of material that can be circumferential or non-circumferential, which can include being spiral or overlapping. The seal flanges can be one or more non-continuous pieces of material that can be circumferential, with the ends of each piece overlapping, or with the ends of each piece having a transition piece that serves as an attaching or fastening element. In the preferred embodiment the gel mask and flanges can be used to form a breathing mask, that can conform to the variable contours of the skin of the face. In one embodiment the sealing pad can have a tackifying agent. The seal can be a gel or non-gel that is tacky to create a tacky seal with the skin.
• In one embodiment the pressure can be used to improve the seal. The pressure can be created by an external circumferential or non-circumferential material. The seal can have the seal improved by one or more expandable chamber that contains a gas, liquid or solid. The expandable chamber can lie external to the circumference of the seal. The expandable chamber can lie within the seal. The expandable chamber can lie between the skin and the seal or can be a combination of chamber locations.
• In another embodiment the gel seal can be a material that when expanded is resiliently deformable and returns to its original size. In another embodiment the seal can return to a size larger than its original size or to a size smaller than its original size. In another embodiment the seal can be non-resiliently reformable.
• In another embodiment sealing pad can contain vents for the ingress and egress of air. The seal can be coated or impregnated with a substance or medication. The use of the substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying age or filter, heating or cooling, gas delivery, liquid or solid delivery. The flanges can be composed of gel or non-gel or a combination of gel and non-gel materials. The flanges, which can be composed of gel or non-gel or a combination of gel and non-gel materials, can be used with a sealing pad that can be gel or non-gel materials. The flanges, which can be composed of gel or non-gel or a combination of gel and non-gel materials, can be used with a sealing pad that can be gel or non-gel materials and a skin covering material.
• A web-like fixation device can be constructed in a geographic or non-geographic pattern that can be random or non-random that has spaces between the seal to include a lace-like, web-like shape with alternating regions of sealing pad and absence of sealing pad such that the sealing pad can include and resemble a web, a series of criss-crossed regions of seal and no-seal; integral, web, or lattice, overlapping strands, non-overlapping strands, a weave or woven strands. a Chinese-finger puzzle configuration; curvilinear or circular patterns; and triangular patterns. The pattern of alternating regions of sealing pad and the absence of sealing pad can be referred to as a web or web-like pattern. The web-like fixation device can be composed of a material that is a gel, a non-gel or a combination of gel and non gel.
• Fixations methods can include but are not restricted to two methods that include overlapping strands and a weave. The first method and structure can include but is not restricted to stands that can be overlapping or non-overlapping and which in the preferred embodiment can include but are not restricted to a gel material that can include but is not restricted to a tackifying material or an adhesive or which can be naturally tacky or: a fabric-like material that can include a microfiber with a high coefficient of friction and increased drag on the skin when the material when a force to include but not restricted to pulling is exerted. When said force to include but not restricted to pulling is exerted on the fixation device, the portions of the fixation in contact with the skin exert an increased coefficient of friction or drag that can increase or accumulate the more the fixation device is pulled upon. This embodiment is based at least in part on an increase in the surface area of the high coefficient material that is in contact with the skin. This represents both a method and a device. A second method and structure and embodiment of the fixation can include but is not restricted to a fixation device that is in the shape to include but not restricted to a weave that can include but is not restricted to resemble the weave of a Chinese Finger Puzzle. The weave when exposed to a force to include but not restricted to a pulling force will tighten in some areas and not in other areas. The weave when exposed to a force such as pulling will tighten and narrow the diameter of the fixation device and constrict around the body part to which it is in contact. The fixation device can be associated with but not restricted to a sealing pad and a skin covering material and an anchoring device and method.
• The fixation device can be formed from a high coefficient of friction material that at least a portion of the fixation device can include a gel that can include but is not restricted to a tackifying material or an adhesive or which can be naturally tacky; or a fabric-like material that can include a microfiber with a high coefficient of friction and increased drag on the skin. Properties of a tacky gel or a high coefficient of friction material are uniquely suited to be used in a fixation device, in particular because of the tackifying adherent nature of a gel to the skin and the capillary action of a microfiber to the skin or a structure that can resemble the structure of a Gecko's footpad, to the skin and because the gel stretches and at least portions of the gel when pulled remains adherent to the skin. In turn, when the gel stretches the gel distributes an increased pressure to potions of the skin. In addition, portions of the gel in one embodiment constrict when dynamically pulled upon. The combination of the high coefficient of friction in concert with the increased pressure of the gel relative to the skin which can be contributed by the constriction on the gel fixation device on the skin create a situation where the gel becomes even more resistant to being pulled off or away from the skin and is an example of a higher coefficient of friction or high drag or resistance to being removed when the gel is in the dynamic state than in the static state. This can represent a greater dynamic to static coefficient of friction for a gel material when a force to include but not restricted to a pulling force is exerted on the gel. Put simply the tackiness of the gel on the skin does not pull away when a limited dynamic force is exerted. The gel can however be pulled off if a strong enough or an accelerated pulling force is applied to the gel fixation device when it is in contact with the skin. The force required for maintaining a fixed position on a body part is highly dependent on the shape and form and size of the body part. In one embodiment an experiment was performed. In another embodiment a simple weave or a more complex weave that is similar to a Chinese finger puzzle that is made of a gel or a high confident of friction can create be constructed to form a fixation device and may provide additional fixation. A fixation device was constructed that was a web-like design which was six centimeters long and which was composed of tacky gel strands with a total of four strands each approximately a half of a centimeter wide. The fixation device was place on a finger one and a half centimeters by two centimeters thick or in maximum diameter. The resting diameter of the fixation device was slightly smaller in width than the finger by approximately a quarter of a centimeter in width at the maximum diameter of the finger. The fixation device was placed over a six centimeter length of the finger. A string was tied with on end on a half a pound weight and the other half tied between the strands of the fixation device. The weight was suspended from the fixation device. The strands elongated. Some regions of the strands appeared to attenuate and other regions appeared to thicken. In some regions of the fixation device the diameter of the fixation device appeared to decrease and exert a compressive force on the skin of the finger. The fixation device remained suspended for over one minute without signs of falling off. The user walked around and the fixation device remained attached as the weight gently bobbed up and down which was done to simulate the real life use of the compression device. The compression device could be force off of the finger if the weight was violently yanked up and down. This is also an important element of the fixation device which should be able to detach itself from the skin if the force is great enough that it might damage the skin but to remain fixed to the skin if the force is a routine daily actions and life physical force. This experiment was performed to simulate the forces that might be exerted on a penis with a condom catheter with a fixation device.
• The web-like pattern can have multiple functions to include making the sealing pad more breathable so that the underlying skin is aerated and so that the sealing pad can be worn for extended periods of time; making the sealing pad more biocompatible so that the web-like sealing pad can move more freely with the users skin, body part or appendage; making the sealing pad more capable of staying in place or fixed or affixed to a body part by creating more than one region of attachment or friction or fixation; by making increasing the functional surface area of the skin to sealing pad. The sealing pad can be annular or non-annular or a combination of annular and non-annular. The sealing pad can be circumferential or non-circumferential or a combination of circumferential or non-circumferential.
• The web-like device fixation device can be used with a sealing pad that can be at least partially covered by a membrane. The web-like device fixation device can be used with a sealing pad that can use a skin covering material.
• In the preferred embodiment the web-like sealing pad can be annular and circumferential around the shaft of the penis nearest to the torso and the web-like sealing pad is composed of gel and conforms to the movements of the penis. Distal to the torso the web-like sealing pad transitions into a solid sealing pad with a bulbous out-pouching that is annular and circumferential around the corona or transition point between shaft and head of the penis. The bulbous out-pouching fits snugly into the corona in circumcised male and in uncircumcised males can fit over the foreskin if un-retracted or on or near the corona if the foreskin is retracted. An alteration in the design can be adapted for uncircumcised males. The bulbous circumferential annular transition of the seal can continue as a gel sealing pad or can transition into the skin covering material that can have the form of a condom catheter of bag like shape that is watertight and can have one or more conduits or tubes that can allow for the egress of urine away from the penis. In addition, one of the tubes can deliver solids, liquids or gasses to the penis that can assist in the comfort or biologic function of the penis that can include delivering a drying agent to include dry air, silicon dioxide, powder, cornstarch, or an alcohol based solution or gel; a medication that can include an antibacterial, antifungal, or antiviral agent; a medication that can treat a disease or condition to include cancer, HIV or other viruses, skin conditions, and pleasure delivery stimulating or anaesthetizing agents.
• In another embodiment the web-like sealing pad and skin covering material can be used with a wound cover to include a bruise, laceration, burn, surgical site or site of trauma either natural or animal or man-made; a cast cover a breast cover or pump, a mask, goggles, eyewear, nose pieces or nostril plugs or devices, earpieces or earplugs or ear-buds, hand covers or gloves, garments, clothing, shoes, socks, a condom catheter or urinary processing device to include a urine bag, a semen processing device to include a male condom, a female condom or a male or female contraceptive device, a diaper or fecal processing device to include an ostomy bag. environmental suit or environmental protective gear, and a medication delivery system that requires areas of the body or skin that are preferentially treated with areas of medication delivery that have spaces or gaps between the sites of medication delivery.
• These alternating patterns of sealing pad can be uniform in frequency of the pattern or can be more frequent at one end of the web of the pattern than at the other end. The seal can be used to anchor or fix the pad or the skin covering material or the device to parts of an organism's body to include the appendages, penis, vagina, internal organs, torso, neck, head, ear, nose, mouth. In the preferred embodiment the spider-like configuration can be used externally or on the skin to include fix and attach a condom-catheter onto the penis or fix a cast or bandage or wound cover onto a body part to include an arm or finger. Other embodiments can include internal body use and can include fix and attach a covering material onto a body organ to include a kidney. ovary, uterus, or bowel.
• The web-like design can be used on non-living objects or substances to include two objects that need to be held in close approximation but require some separation and movement to include earphones and earbuds, or two objects that need to be closely bound to include two electronic communication devices such as an iPod and a cellular phone or earbuds to an electronic device.
• The web-like design can be used as an interface between a living organism and a non-living object to include a finger and sensing device to include a medical device to include a pulse-oximeter, glucose-meter or a blood saturation meter; or non medical uses to include a children's toy, a music device that attaches to the body to include an iPod or cellular phone attached to an arm.
• In the preferred embodiment the web-like fixation device can be gel and can be placed around the upper arm and can have a pocket that can being water-proof. The pocket can hold a musical device that can include an iPod-like device that can be without a jacket or can have a waterproof jacket waterproof jacket. This combination can be used for use in the water to include swimming or surfing or the sand, which can include beach volleyball or sun tanning.
• In one embodiment the gel seal and fixation device and skin cover in combination with the fixation gel web-like anchoring device or in any combination with these elements can include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a male or female contraception device, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove cover and a pants of sleeve or collar or hat cover; an environmental protection gear or device.
• In one embodiment the web-like material can be a gel or a non-gel or a combination of gel and non-gel. In one embodiment at least a portion of the web-like material can have one or more tackifying agents. In another embodiment at least a portion of the web-like material has no tackifying agent. In another embodiment the web-like material can have a combination of tackifying agent and no tackifying agent.
• In another embodiment the web-like fixation device can serve as a cushioning or air-tight seal if the channels are properly organized. Uses can include CPAP and positive pressure masks and a surgical mask.
• The gel seal can be folded upon itself so that the external layer compresses the internal layer to form a self-sealing external compressive force. The skin covering can be wedged between the outer and inner layer of the gel seal. The gel seal can be folded upon itself so that the external layer compresses the internal seal layer to form a self-sealing external compressive force. The skin covering can be wedged between the skin and the inner and outer layer of the gel seal. The gel seal can be folded upon itself so that the external layer compresses the internal layer to form a self-sealing external compressive force. The skin covering can be external to the outer and inner layer of the gel seal. In the preferred embodiment the skin covering material will be attached to the seal to form a substantially airtight and watertight seal to at least a portion of the seal.
• The gel sealing pad can be composed of gel or can be composed with a combination of gel and non-gel materials. The gel seal can be composed of one or more folds to form a self-sealing external compressive force. The seal can be composed of one of more projections or folds that can be configured similar to the shape of the letter ‘E’ or ‘W’ or ‘N’ or ‘M’ or ‘C or ‘S’ or any combination of these shapes such that insinuation of the seal and the skin covering material form an airtight and watertight seal between the skin and the seal and the skin covering material. The sealing pad can be folded or molded or can include a combination of both to form these configurations. The sealing pad can be manufactured or created with a flat cross-sectional shape which can be folded into a desired shape in combination with a skin covering, another sealing pad, or any other suitable device, or it can be manufactured or produced to have an independent structure such as a U-shape or a C-shape or any other suitable shape to include but not restricted to those shapes disclosed herein.
• The skin covering can be composed of one or more skin covering materials or layers of which one or more of these skin covering materials can be attached or wedged onto the seal or between the folds of the seal.
• The skin covering material can be composed of one or more redundant elements or folds that can be configured similar to the shape of the letter ‘E’ or ‘W’ or ‘N’ or ‘M’ or ‘C or ‘S’ or ‘O’ or ‘8’ or any combination of these shapes or variations on these shapes such that insinuation of the seal and the skin covering material form an airtight and watertight seal between at least a portion of the skin and the seal and the skin covering material
• In another embodiment the seal with projections or folds, and the skin covering can include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a male or female contraception device, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove cover and a pants of sleeve or collar or hat cover; an environmental protection gear or device.
• In one embodiment, the sealing pad can be used as a seal that prevents the egress of humidified warm exhaled air from reaching the eye-glasses or a protective eye device or mask of the user and thus prevents the fogging of the eye-glasses or a protective eye device or mask. In the preferred embodiment the sealing pad forms either a single projection or flange or a C shape to embrace the surgical mask. In another embodiment the sealing pad can have a the projection or flange or the C-shape attached to a flat cushion that can form a broader part of the based component that interfaces with the skin to give a more substantial anchoring base while the remainder of the projection or flange or the C shape acts as an additional barrier to the exhaled gas and also serves as an investing or coupling or holding or fixation or invaginating device for and to include a mask which can include a surgical mask. The fold can be composed of gel or non-gel or a combination of gel and non-gel materials.
• The gel seal material can have a geometric shape that is a female or receptive configuration. The shape can be a groove or indentations, invagination or endophytic shape. The gel seal material can have a geometric shape that is a male or protuberant configuration. The shape can be a protuberance or projection or exophytic shape. The skin covering material can have a geometric shape that is a female or receptive configuration. The shape can be a groove or invagination, indentations, or endophytic shape. The skin covering material can have a geometric shape that is a male or protuberant configuration. The shape can be an extuberance or projections or exophytic shape.
• The skin covering material can have one of more geometric shapes that can be male, one of more geometric shapes that can be female or one of more geometric shapes that can be a combination of male and female configurations.
• The seal can have one of more geometric shapes that can be male, one of more geometric shapes that can be female or one of more geometric shapes that can be a combination of male and female configurations. The seal can have one of more geometric or non-geometric shapes that can be minor images of each other. The skin covering material can have one or more geometric or non-geometric shapes that can be minor images of each other.
• In the preferred embodiment the skin covering material will have one or more male protuberances that insinuate themselves into one or more of the female indentations of the gel seal which has a minor image female configuration of the male protuberances of the skin covering material. The seal can have a geometric or non-geometric shape that insinuates itself into the skin covering material. The skin covering material can have a geometric or non-geometric shape that insinuates itself into the gel seal.
• The gel seal, the male projections, the female invaginations or in any combination of these elements can be at least partially composed of non-gel material and can be a combination of gelatinous and non-gelatinous materials. The gel seal, the male projections, the female invaginations or any combination of these components of the seal can be singular or redundant. The gel seal, the male projections, the female invaginations of the gel seal or any combination of these elements can be circumferential or partially circumferential or a combination of both circumferential and partially circumferential.
• The gel seal, the male projections, the female invaginations or any combination of these elements, can be of variable hardness and softness to include softer away from the skin than at the skin covering material, softer away from the skin covering material than at the skin, or a combination or a variation on combinations of hardness and softness between the skin and the skin covering material. The protuberances and invaginations can be composed of gel, non-gel or a combination of gel and non gel materials.
• In one embodiment the gel seal and skin cover in combination with either the folded gel, the male projections, female invaginations or any combination with these elements can be used to form or augment a product to include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove or glove cover and a pants cover, a sleeve cover, a collar cover or a hat or hat cover; a garment or garment cover or a environmental protection gear or device,
• In another embodiment the web fixation device, the sealing pad or the sealing pad with or without redundant elements or folds, the male projections, the female indentations and the skin covering or any combination of these elements can be used to form a product to include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove or glove cover and a pants cover, a sleeve cover, a collar cover or a hat or hat cover; a garment or garment cover or a environmental protection gear or device,
• In another embodiment a sealing pad or a sealing pad with a skin covering material or a combination of a sealing pad or a sealing pad with a skin covering material can be fixed or anchored with a method to include a gel or a non-gel that can that uses a method to include placing a material that can include an anchoring object that can be an protuberant shape to include a natural shape such as the penis or a geometric shape such as a cylinder, an invaginated shape to include an annular or non-annular shape to include a natural shape such as a nostril, ear canal, mouth, vagina, anus or rectum or a geometric shape to include a funnel shape a hollow cylinder or a hollow rectangle or pyramid which can be formed from gel, cyberskin, rubber latex, or silicon such that the anchor is formed by placing said material into an orifice. The orifice can include the nostrils, mouth, ears, anus, urethra, vagina, digestive track to include the esophagus, the respiratory track to include trachea and larynx.
• The anchoring device can be used in combination with a gel seal to create an airtight or watertight seal with at least a component of the user's skin. The seal and the anchor can be used with a skin covering material or a fixation device that does not enter an orifice to include the web-fixation device, adhesives and tapes, or a living or non-living device that can include a catheter or tube, a urinary regulator, a sphincter regulator, a respiratory regulator, a heat or cold device, a pain regulator, an electrical or non electrical physiologic device that can include a physiologic indicator, monitoring device, feedback device, delivery device, permissive or inhibitory device, a tissue replication device or any combination of said devices; biological tissue that can be used to monitor, feedback or deliver or permit or inhibit a biological function or assist or create biological growth or hormone or substance delivery for biological and physiological development, growth, homeostasis or regulation; or any combination of these elements.
• In the preferred embodiment is an anchoring device can be placed into the vagina, and can consist of a gel or Cyberskin tampon-like device that can simulate the shape of the vagina for comfort. The vaginal anchor can be attached to a seal that can be a gel that forms an airtight or watertight seal with the female urethra. The seal can have a skin covering material that can capture the urine released by the urethra and can be in a form to include a bag or condom or tube. The sealing pad and skin covering material can serve as a watertight conduit for removal of urine away from the body without leakage of urine. This application can be used use in females with an incompetent urethral sphincter, pelvic floor muscular dysfunction, muscle and nerve wasting conditions or medical diseases or entity to include multiple sclerosis, senility and amyotrohic lateral sclerosis and in situations where a female cannot use a toilet to include fighter pilots, racecar drivers, surgeons, and astronauts. The fixation device and method can also be used to for sexual stimulation and pleasure and to enhance or improve sexual function or gratification in conjunction with a physiologic device to include a feedback, inhibitory, permissive, delivery, and augmentation methods or devices. Another embodiment can be used as a male or female contraceptive device.
• In another embodiment the anchoring orifice can be the anus and a urinary catheter can be used in a female and the orifice anchor can be used alone or in conjunction with the vaginal anchor. In another embodiment the anchoring orifice can be the anus and a male condom catheter can be attached to the anchoring device.
• In another embodiment the anchoring orifice can be the ear and a skin covering can include a mask, a pair of swimming goggle, or a CPAP mask, and said anchoring device can be attached to the anchoring device.
• In another embodiment the anchoring device can be used with a web fixation device, the sealing pad or the sealing pad with or without redundant elements or folds, the male projections, the female indentations and the skin covering or any combination of these elements can be used to form a product to include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove or glove cover and a pants cover, a sleeve cover, a collar cover or a hat or hat cover; a garment or garment cover or a environmental protection gear or device,
• In another embodiment the gel seal or the fixation device or a combination of these elements, which can be made of a gel, can be used with a skin covering material that can include shoes. Sleeves and socks.
• The orifice-anchoring device can be used alone or in conjunction with the web fixation or anchoring-device. In one embodiment the anal and a penile web fixation device can be used in conjunction with a skin covering material that can include a condom catheter. This application can be used use in males and females with an incompetent urethral sphincter, pelvic floor muscular dysfunction, muscle and nerve wasting conditions or medical diseases or entity to include multiple sclerosis, senility and amyotrohic lateral sclerosis and in situations where a female cannot use a toilet to include fighter pilots, racecar drivers, surgeons, and astronauts. This can also be used to for sexual stimulation and pleasure and to alter, enhance or improve sexual function or gratification. Another embodiment can be used as a male or female contraceptive device.
• In another embodiment, the anchor can include the nostril or nose into the mouth or around the mouth or lips can include Tacky or a sticky or a non-tacky attachment that can include the inner nose or outer nose, pressure on the inner wall of the nostril, fixation band around all or a portion of the users head; connection to the mouthpiece; inside or around the ears; the eyes or a goggle or flexible or inflexible eye piece; a head cap or hat; the hair or moustache; a piecing through the skin or mucosa of the mouth or nose; to the teeth; to one or more teeth; which can be the upper palatine teeth or lower mandibular/buccal teeth or both which can include braces or denture-like or mouth guard or a molded fixation piece that conforms to the inner teeth, the outer teeth the biting surface, a combination of the above, the gums or a combination of the gums and teeth.
• In another embodiment the anchor can be placed within a skin tunnel or crease in the body. A crease in the body can include the crease of the buttocks or adipose folds of the belly in an obese individual or a surgically constructed crease or tunnel can be created. A tunnel in the body can include a surgically constricted crease, an internal cavity, a natural tunnel such as a muscle and bone interface or an internally or externally constructed skin tunnel which can be constricted near and ostomy site. In one embodiment the seal and the skin covering material can be used as an ostomy seal and bag and a skin tunnel to house the anchoring device which can be composed of a material to include a biological compatible silicon, gel, metal or other solid of gel. In one embodiment the anchoring device between the seal and the skin can be magnetic and the anchoring device can anchor the gel seal with the use of a method to include electromagnetic forces or energy.
• In another embodiment the sealing pad or the sealing pad and the skin covering can be joined together using a method to include Zip locks, Velcro, thread, ties, hooks, zippers, adhesives, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlocking devices. A combination of closure methods can be used in combination.
• In another embodiment the sealing pad or the sealing pad and the skin covering can be directly in apposition without overlap and can use a closure mechanism to include Zip locks, Velcro, thread, ties, hooks, zippers, adhesives, tackifying agents, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlocking devices. A combination of closure devices can be used in combination.
• In another embodiment the sealing pad or the sealing pad and the skin covering can be directly in apposition without overlap and can use a closure mechanism to include Zip locks, Velcro, thread, ties, hooks, zippers, adhesives, tackifying agents, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlocking devices. A combination of closure devices can be used in combination. This can be used as a wound covering or cast covering.
• In another embodiment the sealing pad or the sealing pad and the skin covering can be directly in apposition with overlapping elements of either the sealing pad or the sealing pad and the skin covering or a combination of these elements and can use a closure mechanism to include Zip locks, Velcro, thread, ties, hooks, zippers, adhesives, tackifying agents, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlocking devices. A combination of closure devices can be used in combination.
• In another embodiment the seal can be removable and replaceable. The sealing pad and skin cover and fixation device and the anchor or a combination of these elements can be removable or replaceable.
• One embodiment can include attached to include the sealing pad and skin cover and fixation device and the anchor or a combination of these elements, can use an attachment device that can include Zip locks, Velcro, thread, ties, hooks, zippers, adhesives, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlocking devices. A combination of attachment devices can be used with a combination of anchoring devices.
• The preferred embodiment can use a gel seal with a skin covering material that forms and ostomy bag in which the ostomy has a tunnel that contains a silicone ring that is magnetized. The gel seal can also be magnetized or can be ferromagnetic and create a tight bond between the anchor and the gel seal. The gel seal creates an airtight and watertight seal with the skin and the skin covering material, which is an ostomy bag allows for the capture and the flow of fecal material away from the body, This method avoids adhesives, which serve to break down the skin over time and lead to ulcers and infections of the skin. In another embodiment the orifice or a structure in an orifice can be used to include a tooth or teeth for an anchor.
• In another embodiment the orifice or a structure in an orifice can be used to include a tooth or teeth for an anchor. which can be used with a garment or a material to include clothing or a garment or a belt that can be composed of a material to include cloth, fabric, natural or synthetic-man-made materials to include nylon, rayon, and polyester-like materials, plastics, plant based materials, metals and metal mesh material.
• In the preferred embodiment a female urethral urine collector can include a vaginal anchor which can be used to fix a gel sealing pad in position that surround the urethra and forms a watertight seal. To support the fixation of the sealing pad a thong-like garment can be worn that is composed of a comfortable and mildly stretchable fabric that can fit around the buttocks or in the buttock crease of a combination of both. The fabric is attached to either the sealing pad that is softer near the skin than the away from the skin such that the fabric and sealing pad anchor is secure or the fabric material can be attached to the skin covering material which can include the catheter bag, condom catheter, or a frame either flexible or non-flexible or to the vaginal anchor.
• In another embodiment the sealing pad and skin covering material, which is a male condom catheter. To support the fixation of the sealing pad a thong-like garment can be worn that is composed of a comfortable and mildly stretchable fabric that can fit around the buttocks or in the buttock crease of a combination of both. The fabric is attached to either the sealing pad that is softer near the skin than the away from the skin such that the fabric and sealing pad anchor is secure or the fabric material can be attached to the skin covering material which can include the catheter bag, condom catheter, or a frame either flexible or non-flexible.
• In another embodiment the sealing pad and the skin covering device and the orifice anchor can include uses as a wound cover to include a bruise, laceration, burn, surgical site or site of trauma either natural or animal or man-made; a cast cover a breast cover or pump, a mask, a breathing mask that can include a CPAP or BIPAP or positive pressure ventilation mask, an intubation device, goggles, eyewear, nose pieces or nostril plugs or devices, earpieces or earplugs or ear-buds, hand covers or gloves, garments, clothing, shoes, socks, a condom catheter or urinary processing device to include a urine bag, a semen processing device to include a male condom, a female condom or a male or female contraceptive device, a diaper or fecal processing device to include an ostomy bag. environmental suit or environmental protective gear, and a medication delivery system that requires areas of the body or skin that are preferentially treated with areas of medication delivery that have spaces or gaps between the sites of medication delivery.
• In another embodiment the seal can be removable and replaceable and can be attached to an anchor using an intermediary or transitional material that can include a fabric or elastic or gel or a solid to include a metal such that the seal and the anchor are not contiguous but are connected and attached using an intermediary attachment device that can include Zip locks, Velcro, thread, ties, hooks, zippers, adhesives, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlocking devices. A combination of attachment devices can be used with a combination of anchoring devices and transitional materials. In the preferred embodiment the anchoring device is a bite plate in the mouth that has a transitional material composed of a rubbery consistency that attaches to a skin covering material with a gel seal that can be used for use as a CPAP mask.
• In another embodiment the anchoring device is a metal band, which can be the metal band-like structures used in braces that surrounds one or multiple teeth. The metal band can have an attachment projection that can be an annular or non-annular projection that is capable of attaching a wire or rubber band-like structure to the anchored-metal band on the tooth or teeth simulating braces. The anchored-metal band on the tooth or teeth can have a rubber-band like intermediary connector that can connect to connect the skin covering material which can include a frame that can be flexible or non flexible or it can connect directly to the seal which in the preferred embodiment is a gel seal that can form an airtight or watertight seal that can regulate the inhaled and exhaled gases pressure within the respiratory track and this forms a mask that can be used for use as a CPAP or BIPAP or positive or negative pressure mask that can be used for sleep apnea, assisted ventilation.
• In another one embodiment a ventilation mask can be a low profile mask. The low profile mask can be used for a CPAP device that is composed of smaller and less bulky tubes to minimize discomfort to the user and improve comfort and secondarily improve sleep or the mask can produce resistance to exhalation. The mask can be made of lightweight materials to improve comfort.
• In the preferred embodiment the skin covering material is airtight and the gel seal forms an airtight seal with at least a portion of the skin. In another embodiment the skin covering can be breathable and permeable to air. In another embodiment the skin covering material can be a combination of breathable and non-breathable and can have variable air-tightness and air permeability. The amount pressure and the volume of air passage or non-air passage can be alternated or varied.
• In one embodiment the mask can be composed of a single valve or a series of valves that can alter the pressure and resistance of inhaled and exhaled gas or liquids or solids of a combination of gas, liquids and solids. Another embodiment can include a covering material that can experience variations in the permeability of inhaled and exhaled gas or can be composed of a series of covering materials that can have variable permeability and resistance to inhaled and exhaled gases.
• Another embodiment can use a combination of channels and reservoirs that can be controlled to alter the variability in permeability and resistance of inhaled and exhaled gases. The control of the air permeability and resistance can utilize devices that include mechanical, chemical, electromagnetic, vibrational, heating and cooling or a combination of these methods.
• In another embodiment the airway pressure within the mouth can be altered by changing the shape or the volume of the shape or volume or a combination of the shape and volume of the skin covering material to create a device in which the pressure of the exhaled and inhaled gas can be increased or decreased or set at a steady state depending on the resistance within the skin covering material.
• A low profile mask that is composed of smaller and less bulky tubes to minimize discomfort to the user and improve comfort and secondarily improves sleep. In the preferred embodiment it can be used for CPAP. The mask can combine a seal to include a gel, silicone, Cyberskin or ThermoPlastic Elastomers's, with a lightweight material that can include fabric, paper, plastic, metal or other gels. solids liquids or gases to form a more flexible and comfortable breathing unit. In the preferred embodiment, the low profile breathing mask can fit closer to the skin and can be composed of materials, which in one embodiment are breathable and permeable to air and would be composed of a material to include Gortex, paper-wood products The seal of the mask in the preferred embodiment is composed of gel, which can create an airtight and watertight seal. The mask can be comprised of conduits and receptacles and orifices, which can perforate and connect to an external CPAP or respiratory or breathing machine or to exchange air or liquids or solids. In the preferred embodiment the mask would utilize flexible materials for the frame and attachment and covering materials and membranes. Other embodiments could include hardened material for the frame but these would be positioned to minimize discomfort to the user. The mask can combine a lightweight material and a gel to form a more flexible and comfortable breathing unit to include a CPAP mask.
• The breathing mask or ventilation or intubation device can use a gel sealing pad or a sealing pad with a skin covering material in conjunction with a liquid solution or a solid material or a gas or a mixture of these substances as an exchange material that can facilitate the organism gas exchange of substances such as oxygen or carbon dioxide. The mask can facilitate the osmotic exchange of other blood containing substances such as urea, glucose, and electrolytes and minerals and can form as a form of dialysis. The introduction of substances such as medications can be facilitated by the breathing mask to include antibiotics, anti-fungal and anti-viral drugs, surfactant materials and other lung performance facilitating medications. Some of the substances that can be used to exchange vital gases for organisms can include chemical compounds which can carry and release oxygen perfluorocarbons (PFCs of which a specific PFC used is perfluorodecalin; haemoglobin derived from humans, animals, or artificially via recombinant technology, Haemoglobin-based oxygen carriers, to include lecithin surfactants, Oxygent, Oxycyte PHER-O2, and Perftoran.
• In the preferred embodiment a gel sealing pad with a skin covering material that serves as a ventilation tube can be used to intubate an organism. The ventilation tube forms an airtight seal with the digestive track to include the esophagus and GE junction and stomach to prevent liquids from entering the stomach this seal should be airtight and watertight. Coincidentally a second seal is formed with the respiratory track to include the larynx, trachea or bronchi or their branches. Once a seal is formed with at least one of the two passages, the digestive passage or the respiratory passage or with both passages, the liquid ventilation can commence.
• In the preferred embodiment the intubation device can be branched with on branch extending into the esophagus and digestive track and the other appendage extending into the trachea or bronchi.
• In another embodiment the sealing pad can be used to isolate a portion of a body cavity to include the oral pharyngeal space for diagnostic or therapeutic care that can include radiation, radiation augmentation or protection, and the delivery of medication or the restriction of medication delivery. The sealing pad can be used to prevent the flow of a substance or to isolate two regions to include preventing reflux of digestive juices from the stomach and the esophagus from entering the oral airway.
• In another embodiment the isolation of the a portion of the esophagus can be created using gel seal plugs to include the treatment of a portion of the esophagus for cancer or pre-cancerous lesions such as Barret's esophagus by placing sealing pads caudad and cranial (above and below) the area of the esophagus to be treated. The seals will serve as plugs and can have one or multiple conduits that can provide for the instillation and removal or medication or therapeutic substances into the treatment region.
• In another embodiment the isolation of the a portion of the bladder can be created using an annular ring and a sealing cover that can be a gel or a non-gel material to isolate a portion of the requiring treatment. The seal or the sealing cover can have one or multiple conduits that can provide for the instillation and removal or medication or therapeutic substances into the treatment region while protecting the remainder of the bladder from the effects or side-effects of the medication or therapeutic substances.
• In another embodiment a sealing pad or a seal pad and skin covering can contain a reservoir containing a solid or liquid or gel or gas that can include a therapeutic, pleasurable, moisturizing, humidifying or drying, heating or cooling substance or medication. The use of the substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying agent or filter, heating or cooling, gas delivery, liquid or solid delivery.
• In the preferred embodiment an airtight and watertight wound cover can deliver medication to a wound in a dose and a periodicity that can be regulated to include mechanical or digital or nanotechnology or electromagnetically or kinetically or by vibration. In another embodiment a CPAP mask cast with a gel seal and skin covering material can deliver humidified air to the skin mucosa of the mouth to preserve internal humidification.
• In another embodiment the reservoir can be used with a breast pump and a scent simulating an infant's scent can be released. In another embodiment aerosolized Oxytocin can be released. In another embodiment the reservoir can be controlled by an indicator or a feedback device. In another embodiment the reservoir can be controlled by an indicator or a feedback device that can measure and respond to physiologic and non-physiologic measurements to include the need to control upstream arterial flow in a laceration with bleeding. In this circumstance the seal acts both as a seal and a tourniquet.
• In another embodiment the seals can have an equal pressure or force compressing or holding them in place against the skin or at least one of the seals can have having a greater pressure or force compressing or holding the seal in place against the skin than other seals.
• In another embodiment the reservoir can be a compressive device that can adjust the airtight seal in situations that require greater force this can include a situation where a laceration includes an uncontrolled bleed that fills the sealing pad and skin covering internal chamber with blood. In that situation the goal is to attain a pressure in the internal chamber that is equal to, or greater than or less than the arterial inflow pressure which in one embodiment can be the upstream sealing pad, which is acting as a tourniquet. In this situation the object is to allow some arterial inflow to keep the tissue alive but restrict the bleeding. In the preferred embodiment this can be measured with a monitor to include an oxygen monitors at the distal downstream seal to access tissue viability while the upstream arterial flow with a monitor to include an a blood pressure monitor or an ultrasound Doppler device to access the arterial waveform.
• In one embodiment the gel seal can include a reservoir that can be used with a skin covering material which can be used as a cooling or anti-itch or anti-irritation device for the skin beneath a cast in a cast or wound cover.
• In one embodiment the gel seal can include a reservoir in combination with channels or conduits or tubes or wires or optics can as change the sensation or biology or physiology of the skin to include a cooling or anti-itch or anti-irritation device for the skin beneath a cast or wound in a cast or wound cover.
• In one embodiment the gel seal can include a reservoir that can be used with a skin covering material and can be used as uses as a wound cover to include a bruise, laceration, burn, surgical site or site of trauma either natural or animal or man-made; a cast cover a breast cover or pump, a mask, a breathing mask that can include a CPAP or BIPAP or positive pressure ventilation mask, an intubation device, goggles, eyewear, nose pieces or nostril plugs or devices, earpieces or earplugs or ear-buds, hand covers or gloves, garments, clothing, shoes, socks, a condom catheter or urinary processing device to include a urine bag, a semen processing device to include a male condom, a female condom or a male or female contraceptive device, a diaper or fecal processing device to include an ostomy bag. environmental suit or environmental protective gear, and a medication delivery system that is benefited by the delivery of a substance from said reservoir.
• The sealing pad, the skin covering or a combination of the sealing pad and skin covering can contain a feedback or indicator or measuring device which shall be referred to as an indicator or sensor device. The indicator can assess and can include physiology of the body that can include pulse, blood pressure, temperature, glucose levels, biomechanical measurements, carbon dioxide and oxygen and gas levels, oxy and deoxyhemoglobin levels and other basic metabolic functions and measurements to include wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, muscular function, substance levels to include drugs and medications and non-physiologic measurements to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications a combination of physiologic and non-physiologic measurements.
• In one embodiment the sealing pad and skin covering can have a physiologic feedback measurements such as pulse and blood pressure detector in which measurement information can be transmitted using a method to include a visual signal that is projected using a method to include an image on a screen, to an object that can be transparent, translucent or opaque; onto the retina, onto a region in the visual field of a pair of swimming goggles that monitors a swimmers work-out.
• In another embodiment the sealing pad and skin covering can have an indicator of wetness or dryness which can be displayed using a method to include a color indicator to include encapsulated cobalt chloride, which is blue when dry and pink when wet or fizzy tablets to include Alka-Setlzer-like tablets which fizz when wet, which can be used with a wound or cast cover.
• In another embodiment the sealing pad and skin covering can have an indicator to include pH, which can be displayed using a method to include a color indicator to include a pH indicator dye to include the detection of urine using a method to include standard pH detection strips or materials for detecting the alkaline part of urine which s ammonia, NH3, which can permeate low-density poly-ethylene (LDPE) and changing their color; which can be used with a urinary condom.
• In another embodiment the sealing pad and skin covering can have an indicator to include pH protein, sperm, or fructose or other sugars, which can be displayed using a method to include a color indicator to include a pH indicator dye to include the detection of semen or vaginal fluid. For the male the pH of semen is 7.2 to 7.8 and for the female the pH of vaginal fluid is 3.8 to 4.5 also semen contains specialize proteins which can include a method to include anti-semen antibodies or using biuret solution to indicate the presence of protein which can be measure using a microchip or a color indicator which can give a signal to include an analog or digital signal, which can be used with a female or male contraceptive device to indicate mingling or leakage or loss of integrity between the penile and the vaginal side of the seal and skin covering material. In one embodiment to include if a male condom is used then an indicator can be place on the outside of the condom. If sperm and seminal fluid leaks to the outside then the ph of the vaginal fluid will change because of the difference between the vaginal and seminal pH and this change can be measured with a color indicator, or an indicator containing anti-sperm antibodies which when in the presence of sperm reacts and creates a reaction that can be detected by an analog or digital method or a sugar indicator which when fructose is present (fructose is found in seminal fluid) will be detected and will provide an analog or digital signal.
• In another embodiment the sealing pad and skin covering can have an indicator to include a gas or pressure indicator with a breathing mask which can include a CPAP, BIPAP, variable, ventilation, intubation device, that can detect Oxygen and Carbon Dioxide level or can detect pressure levels or can detect a combination of gas and pressure levels. This detection device can then provide feedback to either an internal or external device that provides for variations and delivery or gas or pressure.
• In another embodiment a sealing pad and skin covering can become a contained and localized isolation chamber or environment to include managing a body part or the entire body to include managing the pH, gas content, the aerobic or anaerobic nature of the isolated environment, elemental content, substance or medication content, electromagnetic content to include radiation or visible or non-visible light spectra to include UV and infrared light, to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications.
• In the preferred embodiment the sealing pad and the skin covering material can serve as an isolation chamber which can serve as a mini therapeutic or hyperbaric oxygen chamber in which the management of the pressure or gas levels can utilize a reservoir in the sealing pad or skin covering or channels or conduits for the ingress and egress of gas to include oxygen and other gases and to manage the pressure in the chamber to include a pressure that is less than, equal to or greater than atmospheric pressure. Uses of this isolation chamber can include the treatment of wounds, infections to include aerobic infections which can be denied oxygen, anaerobic infections which can be killed with oxygen or in an oxygen only environment, antibiotic resistant infections to include MRSA infections in which the antibiotic level, or a toxin or a gas mixture or a combination of these elements can be used to treat the infection at a localized site with specific therapeutic methods while isolation other regions of the body from these same therapeutic levels.
• In another embodiment the sealing pad and the skin covering material can serve as an isolation chamber which can serve as a therapeutic chamber to deliver radiation sensitizing materials that can include 5-chlorodeoxycytidine (5-CldC) or 5-halo-2′-halo-2′-deoxy-cytidine or -uridine derivatives, Tetrahydrouridane (H.sub.4 U) and 2′-deoxytetrahydrouridine (dH.sub.4 U) co-administered with the deoxycytidine derivative to inhibit deamination of the deoxycytidine derivatives, agents to reduce the amount of competing metabolites to favor CldC, such as 5-fluorodeoxyuridine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU), chlorozotocin, 1,3-biscyclohexyl-1-nitrosourea (BCyNU), and 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU). CCNU, BCyNU, and BCNU; such that when radiation is administered the area being isolated can achieve an added effect from the radiation.
• In another embodiment the sealing pad and the skin covering material can serve as an isolation chamber which can serve as a therapeutic chamber to deliver radiation resistant materials to include antioxidant compounds such that when radiation is administered the area being isolated can achieve a diminished effect from the radiation.
• In another embodiment the sealing pad and the skin covering material can serve as an isolation chamber, which can serve as a therapeutic chamber which can be used to treat a laceration with uncontrolled bleeding. The sealing pad can contain a reservoir or bladder of have a device that constricts or contracts the gel seal between the seal and the skin, within the seal or external to the seal, In the preferred embodiment the constricting seal is placed at the location of the wound where there is arterial inflow. The compressive seal can serve as a tourniquet that can allow blood flow into the wound to increase, decrease, remain the same, vary the flow or any combination of these flow speeds or elements. The wound can be isolated to achieve keeping the wound clean, tamponating the wound, stopping the bleeding and treating the wound that can include medicines to include antibiotics, coagulants and anticoagulants, QuikClot and Chitosan, an extract from shrimp shells and blood products to include platelets. The pressure within the isolation chamber can also be regulated to increase, decrease, remain the same, equilibrate or vary or be a combination of these elements relative to the seals, tourniquet, tamponating agents, atmospheric pressures, arterial or venous or body pressure or a combination of these elements can be used to regulate the optimal equilibrium between adequate blood flow and oxygenation to the tissue and at and distal to the laceration. The oxygen and gas content in the isolation chamber can be controlled and regulated to also include assist in physiologic homeostasis and cell survival and clotting and other primary biological functions for survival of the organism and the components of the organism. In the preferred embodiment can include the combination of the inflow gel seal controlling and regulating arterial inflow in the lacerated artery through regulated pressure on the artery, in combination with regulated oxygenation within the isolation chamber, in combination with varied pressure within the chamber, in combination with medications to induce clotting, in combination with wound isolation and medications to reduce infections, may provide for greater cell and tissue and limb and organism survival. In another embodiment one or more chambers can be utilized which can include treating the tissue distal to the laceration with a second isolation chamber with characteristics dissimilar from the first chamber. Additional treatments can include electromagnetic energy to include UV energy, Infrared energy, radiation, visual energy fields, kinetic, and vibrational energy. The isolation chamber can be surrounded by or integrated into an air-cast to supplement isolation and external pressure.
• In another embodiment the sealing pad and the skin covering material can serve as an isolation chamber which can serve as a therapeutic chamber to have a pressure less than the ambient atmospheric pressure to include induce blood flow to a tissue to include a muscle group that is a risk for compartment syndrome.
• In another embodiment the sealing pad and the skin covering material can serve as an isolation chamber which can serve as a therapeutic chamber to treat a varieties of conditions to include burns, to remove tattoos, to heal wounds, ulcers and lacerations in patients to include diabetes, immune-compromised individuals, patients with oxygen deprivation to tissue to include diabetics, patients with atherosclerosis, frostbite, stroke, emboli from solids, gels, liquids or gases to include nitrogen in scuba divers; to induce sensory stimuli that can include pleasure or perceived pleasure to include organs such and the skin, penis or vagina or breasts, to induce or reduce pain to include uses for diagnostic or therapeutic purposes; to treat a body part to include the skin, mucosa, fascia, a muscle, a body organ, to treat a the whole body or a body part that requires a change in metabolic and physiologic characteristics to include decreasing the metabolism using a method to include cooling and delivering a medication locally; increasing the metabolism to include warming, and medication delivery to include amphetamine, to increase or decrease pain and pleasure and all other animal sensations which can be used for the treatment for cancer, pain relief, oxygen and vascular function and cell function and dysfunction to include stoke, cell death, aging and rejuvenation.
• In another embodiment the sealing pad and the skin covering material can include an indicator device that can be utilized to provide feedback to the regulate the seal, the skin covering material, the internal environment between the seal and the skin covering material complex and the skin, the external environment outside of the seal and the skin covering material complex, or a combination of these regions and elements. The indicator can be used to regulate and adjust and measure parameters to include the pH, gas content, the aerobic or anaerobic nature of the isolated environment, elemental content, substance or medication content, electromagnetic content to include radiation or visible or non-visible light spectra to include UV and infrared light, to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications, and the biologic and physiologic parameters of the tissue or body part being isolated. The material or energy being delivered or removed from the isolation chamber can be located between the sealing pad and skin covering complex and the skin, or can be a part of the sealing pad and skin covering, or can be external to the sealing pad and skin covering or can be a combination of these elements.
• The delivery or removal system for material or energy being delivered to or removed from the isolation chamber and the skin, body part or organism, can be located between the sealing pad and skin covering complex and the skin, or can be a part of the sealing pad and skin covering, or can be external to the sealing pad and skin covering or can be a combination of these elements. The matter or energy being delivered or removed can be delivered or removed by methods to include channels, tubes, wires, osmosis, kinetic energy or electromagnetic energy.
• The indicator and the adjustment can provide feedback can include physiology of the body that can include pulse, blood pressure, temperature, glucose levels, biomechanical measurements, carbon dioxide and oxygen and gas levels, oxy and deoxyhemoglobin levels and other basic metabolic functions and measurements to include wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, muscular function, substance levels to include drugs and medications and non-physiologic measurements to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications a combination of physiologic and non-physiologic measurements.
• The sealing pad and the skin covering and the indicator can be connected to at least one device that can adjust, regulate, manage, and assess the physiology or biology of the isolated tissue or body part or organism and adjust the device to optimize, alter or coordinate the needs or biologic function or physiology of the isolated tissue or body part or organism.
• In the preferred embodiment the combination of a sealing pad and the skin covering and at least one indicator can be connected to an isolation chamber which can serve as a mini therapeutic or hyperbaric oxygen chamber in which the management of the pressure or gas levels is controlled by at least one indicator which provides feedback to adjust, regulate or manage the pressure and gas levels and mixture in the chamber. Uses of this isolation chamber and skin covering and indicator can include the management and regulation and assessment and treatment of wounds, infections to include a wound, a laceration, aerobic infections which can be denied oxygen, anaerobic infections which can be killed with oxygen or in an oxygen only environment, an antibiotic or antifungal or antiviral resistant infections to include MRSA infections in which the antibiotic level, or a toxin or a gas mixture or a combination of these elements can be used to treat the infection at a localized site with specific therapeutic methods while isolation other regions of the body from these same therapeutic levels.
• In another embodiment the sealing pad and the skin covering material and at least one indicator can serve as an isolation chamber which can serve as a therapeutic chamber in which at least one indicator can be used for the adjustment, management and regulation and assessment and treatment which can be used to treat a ailment to include cancer and in which the feedback mechanism can be used to locally deliver radiation sensitizing materials that can include 5-chlorodeoxycytidine (5-CldC) or 5-halo-2′-halo-2′-deoxy-cytidine or -uridine derivatives, Tetrahydrouridane (H.sub.4 U) and 2′-deoxytetrahydrouridine (dH.sub.4 U) co-administered with the deoxycytidine derivative to inhibit deamination of the deoxycytidine derivatives, agents to reduce the amount of competing metabolites to favor CldC, such as 5-fluorodeoxyuridine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU), chlorozotocin, 1,3-biscyclohexyl-1-nitrosourea (BCyNU), and 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU). CCNU, BCyNU, and BCNU; such that when radiation is administered the area being isolated can achieve an added effect from the radiation.
• In another embodiment the complex of the sealing pad and the skin covering material and at least one indicator can measure and be used to include manage, adjust, regulate and assess the oxygen and carbon dioxide and pressure in a breathing apparatus that can include a ventilator, CPAP device, or anesthesia device that can measure the physiology of the organism, with parameters to include oxygen and carbon dioxide levels, anesthetic levels and the breakdown products of the anesthesia, the pressure of the gas being inhaled and exhaled and delivered and removed, the sound of the snoring of the organism and the biological and physiological parameters of the organism including arterial oxygen saturation levels.
• In another embodiment the complex of the sealing pad and the skin covering material and at least one indicator can measure and be used to include manage, adjust, regulate or assess the sound of the snoring which can be used manage, adjust, regulate and assess the physiologic or biologic parameters of the organism who is snoring and adjust the gas levels and the pressure to minimize snoring while maintaining proper homeostasis and health of the organism.
• In the preferred embodiment the organism with the complex of the sealing pad and the skin covering material and at least one indicator to assess and give feedback on physiology and biology, which can include gas exchange, sleep apnea, arterial saturation, and CO2 levels are coordinated with the organisms physiology which can include causes of snoring or restless-leg-syndrome, that are affecting at least one organism, which can include the second organisms restful sleep.
• In the preferred embodiment there can be a combination of a sealing pad, a skin covering, an anchoring device, a Web-like Fixation and a feedback device or any combination of these elements can be used as a condom catheter and can train or affect or improve function to include the neuro-musculature units for micturition, urination, control of urination, penile, prostate, bladder, vaginal muscular contraction and relaxation, neuro-musculature control, anal and rectal, the pelvic floor muscle and fascial control. In the preferred embodiment an indicator can be present to provide neuro-muscular strength and tone and signal that can be connected or can be used separate from a neuro-musculature stimulating unit that can help train the neuro-muscular system for urination or can automatically trigger a neuro-muscular stimulus that can provide neuro-muscular control to the dysfunctional body function to include the neuro-musculature units in an effort to improve and control urinary function. The indicator and sensor and the feedback and stimulating unit can be in the sealing pad, a skin covering, an anchoring device, and a feedback device or any combination of these elements and located in the vagina, rectum and anus, the tissue around the penis or vagina or anus, prostate, pelvic floor. In one embodiment there can be wires implanted in the musculature that assist urination that have an input and an output component that can connect the tissue of interest that is internal within the body to the skin or external to the skin or another internal tissue which can be interfaced to the condom catheter or training unit through electrodes. Other applications of this form of stimulation can include treating or facilitating and enhancing erectile function, orgasm, pleasure, arousal and prolongation of these and related biological functions.
• In another embodiment the feedback mechanism can contain at least one input and one output signal or any combination of inputs or outputs that can include electromagnetic, kinetic, and motion and other sensory signals.
• In the preferred embodiment the complex of the sealing pad and the skin covering material and at least one indicator can assess and give feedback on physiology and biology, or mechanical or environmental stimulus or information, and said information can be transmitted to a device that can alter the physiology or biology or mechanical or environmental stimulus or other information
• In another embodiment the indicator can be used to improve an organism's physiology and biology, which can include gas exchange, sleep apnea, arterial saturation, CO2 levels, muscle twitching to include restless-leg syndrome in order to improve the biology of at least one organism.
• In the preferred embodiment the complex of the sealing pad and the skin covering material and at least one indicator can assess and give feedback on physiology and biology, or mechanical or environmental stimulus or information, and said information can be transmitted to a device that can alter the physiology or biology or mechanical or environmental stimulus or other information to include snoring or the sound of the ventilator or tubes near the snoring individual, which can be measured and the information transmitted to a device to include an acoustic altering device that can include noise cancellation computers, electrical devices, earbuds or earphones which from a distance or be located on or near or at one organism can cancel mute, transmute or alter the sound of the snoring, for at least on organism.
• In another embodiment at least one indicator can be used to assess and give feedback on physiology and biology or mechanical or environmental stimulus or information, and said information can be transmitted to a device that can alter the physiology or biology or mechanical or environmental stimulus or other information to include snoring, which can be measured and the information transmitted to a device to include an acoustic altering device that can include noise cancellation computers, electrical devices, earbuds or earphones which from a distance or be located on or near at one organism can cancel mute, transmute or alter the sound of the snoring, for at least one organism
• In another embodiment the indicator device can have its function to include noise from a ventilator be measured and the information transmitted to a device to include an acoustic device that can include a computer or noise cancellation device or earbuds or earphones which can affect from a distance with speakers or be located on or near or at least one organism or one machine to cancel the sound of the machine which can include a ventilator or monitoring device, treatment device, pleasure device to include background sounds, environmental device to include an air conditioner or humidifier or dehumidifier.
• In another embodiment at least one indicator can measure and be used to include manage, adjust, regulate or assess the sound of the snoring which can be used manage, adjust, regulate or assess the physiologic or biologic parameters of the organism who is snoring and the audio signal can be transmitters using a method of wires or optics or other transmitter methods or wirelessly or a combination of these methods, to the snoring organism or at least on other organism such that the snoring sound can be cancelled out using a device to include acoustic canceling or sound canceling techniques that is the preferred embodiment can be include earphones, earbuds, or a room speaker to cancel or minimize or mute or transmute the sound to provide a more beneficial or pleasant or acceptable sound to one or more of the snoring and the non-snoring individuals.
• In another embodiment a sensing device can be used to create a signal that can include a digital or analog signal that can be stored and processed and transmitted by or into a device that can include a computer-like device, an electrical or mechanical device that can store and process information digitally or analog. That information can be utilized to control a second device that can include a sealing pad, a sealing pad with a skin covering, a sealing pad with a skin covering and indicator device, a feedback device, or a machine that can include a machine used for biologic and physiologic functions that can include breast feeding, pumping the breast for the extraction of breast milk, pleasurable stimuli or sensations or pain and pleasure to include or alteration of physiology or biologic functions of bodily organs to include the breasts, lips, ears, skin, mouth, rectum and anus, penis and related structures such as the scrotum, clitoris and vagina and related local structures such as the labia, toes and fingers. Sensations and stimuli and material applications can include wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications and non-physiologic measurements to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications a combination of physiologic and non-physiologic measurements.
• Other embodiments include auditory signals to include the human hearing range and above and below the human hearing range; electromagnetic signals to include infrared and ultraviolet; sensory stimulus to include heat and cold, wet and dry, pain and non-painful and pleasurable stimulation; olfactory and smell sensations to include pleasant and unpleasant odors; taste to include salt, sweet, acrid, bitter, sour, umami, pleasant and un pleasant tastes; vibration and kinetic stimulus to include pinching, piercing, hard touch, light touch, vibration, and proprioceptive stimulus. The stimuli can be used singular or multiple and can be used as one or multiple stimuli or categories.
• In the preferred embodiment a nipple shape device to simulate the natural shape of a mother's breast can have sensing devices that can include touch and pressure wetness and motion and suction pressure sensors. A baby can suck onto this device and the touch and pressure wetness and motion and suction pressure can be recorded and stored in a device with can include a computer-like storage device. This signal can then be transmitted to a breast pump that can then simulate one or more of these sensory inputs and outputs that best simulates the natural sucking sensation of the infant breastfeeding. The purpose of this is to simulate natural breastfeeding and improve the let-down reflex and the natural sensation of the infant and mother breastfeeding bond. Other sensory inputs that can be acquired and stored and transmitted and simulating during breast pumping can include the olfactory to include the scent of the infant, wetness, visual including images to include the infant breastfeeding and not breastfeeding, auditory including sounds to include the infant breastfeeding and not breastfeeding, taste including taste to include the infant breastfeeding and not breastfeeding, kinesthetic and touch including touch to include the infant breastfeeding and not breastfeeding, and other sensory input that might stimulate breast milk let-down and quantity. The sealing pad or the sealing pad and the skin covering material or the sealing pad and skin covering material can contain a device to include a vibrational, compressive, suction, undulating device that is contained within or on the sealing pad or the sealing pad and the skin covering material or the sealing pad and skin covering material and can be used to simulate and mimic the input to include the suckling or breast feeding of the organism to include an infant that is human or non-human.
• In another embodiment, the infant can be taught how to breastfeed or suck from a man-made nipple using a similar device to teach the infant how to bottle feed. In another embodiment, a massage can be simulated to recreate the massage or touch of a massaging individual an a body part that can include relief of pain, muscle spasm, pleasure, or for the sense of human contact.
• In another embodiment, sexual pleasure can be simulated and attained using a similar device with a shape that can include a mouth, tongue, lips, or combination of these body parts that can be used for pleasure to simulate licking, and sex to include oral sex for and on either gender and on or by any body part. In one embodiment the device can be a sex toy which is programmed to simulate another human beings sensory input and output to include touch, caress, probing, sucking, kissing, licking thrusting, ejaculating, or having an orgasm, and can be shaped like a hand, mouth, tongue, lips, penis, vagina or anus.
• Other embodiments auditory signals to include the human hearing range or above or below the human hearing range; electromagnetic signals to include infrared and ultraviolet; sensory stimulus to include heat and cold, wet and dry, pain and non-painful and pleasurable stimulation; olfactory and smell sensations to include pleasant and unpleasant odors; taste to include salt, sweet, acrid, bitter, sour, umami, pleasant and un pleasant tastes; vibration and kinetic stimulus to include pinching, piercing, hard touch, light touch, vibration, and proprioceptive stimulus. The stimuli can be used singular or multiple and can be used as one or multiple stimuli or categories.
• In one embodiment an animal to include an organism to include a human, a pet, a cat, a horse or a dog that can utilize a device that can be in the form or simulate the form or function of a hand, which is programmed to simulate the touch of the pets owner. This can be used in a kennel crate, a car, or used in a time when an owner is not available to the pet such as when the owner is at work, driving the car, or busy with other activities,
• In another embodiment a camera or viewing or listening or sensory device be present to assess at least one viewed organism at a distance. Viewing can occur on a television, computer like device to include a computer, iPad-like device, cell phone, iPod-like device, a screen, a audio speaker-like device or other sensory devices that be multiple sensory inputs which can be combined. At least one organism can be programmed into a computer-like device to input and output sensory information that can include touch and voice or scents and non-sensory information to include deliver food or water. Both the viewed and the viewing organism can deliver the sensory and non-sensory information to the viewed or viewing organism.
• In the preferred embodiment the owners of a dog could have their voices and touch programmed into a computer and when the dog is lonely it can call the owner by a signal and the owner can provide a sensory or non-sensory stimulus to the dog to include an auditory signal to include soothing words which can be either programmed words or live words, or touch which can be either programmed petting or live petting. In another embodiment a cats purr can be simulated or recorded or transmitted with an auditory device can be simulated with an auditory device for the cat's owner as recipient or the brushing up or rubbing of a cats fur against a hand can be simulated or transmitted with a tactile device to simulate the cat's fur for the cat's owner as recipient.
• The sealing pad, sealing pad and the skin covering can contain a device. The device can be an auditory unit for amplifying sound. The device can be an auditory analog to digital converter with wireless capabilities. The device can be an auditory unit that is hard wire connected to another device that promotes auditory communication such as an electronic device that has input and output capabilities to communicate with one or multiple individuals. Some uses can include airplane travel, operating room communication, hospitals, old age homes, subways, buses, trains, manufacturing and non-mechanical and include HEPPA filters, specific agent detoxifying or anti-germ filters, a substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying agent or filter; heating or cooling device, alter the pressure relative to the ambient air, humidifying.
• The device can be mechanical to include a small fan, a mechanical filter, a small heater or cooler, a defogging device, alter pressure, HEPPA filters, specific agent detoxifying or anti-germ filters, a substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying agent or filter; heating or cooling device, alter the pressure relative to the ambient air. The device can be a nanotechnology device to include a device that serves as an air filter, anti-germ agent and detoxifying agent, defogging agent, heating and cooling, alter the pressure. The device can have a mechanism device to facilitate healing utilizing electrical stimulation, ultrasonic waves, electromagnetic wave, pressure, vibration, alter the gas mixture.
• The low profile breathing mask can have a feedback device that can assess the users' physiologic measurements and non-physiologic measurements. The low profile breathing mask can have an audio or visual device that can assess the user. The mask can have fenestrations to allow flow of materials between the outer environment and the environment between the mask and the user. The fenestrations can be expandable material, a humidity filter, and a gas exchange material. Uses of the fenestrated mask can include a surgical mask, a ski mask, an athletic mask, and an industrial mask. The CPAP can be combined with a noise cancellation unit to fit into the ear orifice or surround the ear orifice. The CPAP Mask can fit over or surround a portion or all of the head.
• In one embodiment a cast cover can incorporate a device that can include a fan that can be used to cool the skin or reduce itching or irritation from the cast.
• In one embodiment a wound cover can incorporate a device that can include the ability to deliver a substance which can be a solid, a gel, a liquid or a gas that can be used to cool the skin or reduce itching or irritation from the wound. The delivery device can receive its substance from a reservoir that is incorporated in the cast cover or from an external source that can be delivered through wires, optics, channels, conduits or tubes.
• In another embodiment, the device can include an olfactory device that can be worn as a nasal mask and can deliver the scent of a mother or a father to a premature infant in an incubator or in isolation such that the infant received sensory stimulation to bond with one or more organisms.
• In another embodiment, the device can include a sensory device worn at the movies that can deliver a sensory input that can include the use of a mask that can deliver an olfactory input, or a sucking device that can deliver a gustatory or taste sensation.
• In another embodiment the sealing pad or the sealing pad and skin covering material can be an auditory device with the ability to transmit and receive an auditory signal and transmit it through an auditory modulating device to a second organism with a sealing pad or the sealing pad and skin covering material can be an auditory device with the ability to transmit and receive an auditory signal.
• In the preferred embodiment the sealing pad or the sealing pad and skin covering material can include an earbud and a microphone receiving auditory device, the input microphone can also be separate from the output listening device be separate. These devices can be used on a vehicle or on a noisy environment to include a train or boat or car or airplane where the ambient noise is very high and can be damaging to the ears and speaking to an individual often involves turning the head to the individual which at the end of the travel can result in a stiff neck and a hoarse voice At least one organism can speak into the microphone and the audio signal is processed by an audio processing and modulating device which can amplify the voice or noise cancel the non-voice audio signal using standard devices for amplification of voice and noise cancellation. The device then transmits the signal to at least one organism who can then listen and speak to at least one organism using a similar mechanism and device such that the receiving and sending audio signal can be shared by at least one organism. In one embodiment this device can be an accessory for or be built into a computer, iPod-like device, iPad-like device, cell phone-like device or walkie-talkie like device.
• The device can be incorporated in the sealing pad and or the sealing pad and skin covering material or the device can be external to the sealing pad and or the sealing pad and skin covering material and obtain input from an external source that can be delivered through wires, optics, channels, conduits or tubes.
• Current CPAP devices create positive end expiratory airway pressure. This allows the airways and the bronchi to remain open and/or distended. These devices require an external machine that creates positive airway pressure. These machines are bulky and uncomfortable. Patient compliance is limited by these machines. These machines leak and fall off and can be over variable effectiveness. This invention reduces or simplifies or eliminates the need for external positive airway pressure generating mechanical machines.
• The goal of this variation on a CPAP mask and device is to miniaturize the CPAP product and make it more users friendly. The miniaturized breathing mask which can be used as a CPAP device can be composed of a reservoir system wherein the air intake is equal or nearly equal to the normal inflow of air and has ambient pressure-inflow equal to or approximately equal to unimpeded inflow and equal or approximately equal to the users environment. The device will create a resistance to outflow this creating a continuous positive airway pressure or device can be internal to the user's mouth or nose. The device can be a combination of internal and external to the user's mouth or nose. The device can be used on the user's nose/nostril, mouth, or a combination of nose/nostril and mouth. The device can be composed of a gelatinous elastomer that fits into or around the nasal orifice/nostrils.
• The device can be composed of a gel, a non-gel or a combination of a non-gelatinous material and gelatinous elastomer that fits into or around the nasal orifice/nostrils. The device can be composed of a gelatinous, a non-gelatinous material that fits into or around the mouth or oral orifice a combination of a non gelatinous material and gelatinous elastomer that fits into or around the mouth or oral orifice. The device component is composed of at least one valve that provides for unimpeded inflow of air and with impeded outflow of air that increases the air way or air resistance to the outflow of air. The valve or valves can be arranged to increase outflow air resistance in a steady consistent manner near the user relative to the external environment; in a manner in which the pressure is greater near the user relative to the external environment; in a manner in which the pressure is less near the user relative to the external environment.
• The device can be composed of at least one reservoir that provides for nearly or unimpeded inflow of air and with impeded outflow of air that increases the airway or air resistance to the outflow of air. The reservoir or reservoirs can be arranged to increase outflow air resistance in a steady consistent; in a manner in which the pressure is greater near the user relative to the external environment. The device can be composed of at least one reservoir and at least one valve that provide for nearly or unimpeded inflow of air and with impeded outflow of air that increases the airway or air resistance to the outflow of air. The reservoir or reservoir s and valve or valve's can be arranged to increase outflow air resistance in a steady consistent manner near the user relative to the external environment; in a manner in which the pressure is greater near the user relative to the external environment or; in a manner in which the pressure is less near the user relative to the external environment.
• The nasal piece can be composed of one or more materials. The nasal piece can be composed of one or more materials that allow the minimal or unimpeded inflow or air but create an increase in outflow pressure while allowing the egress of exhalent such as carbon dioxide. The mouthpiece can be composed of one or more materials. The mouthpiece can be composed of one or more materials that allow the minimal or unimpeded inflow or air but create an increase in outflow pressure while allowing the egress of exhalent such as carbon dioxide. Any combination of the nasal and mouthpiece can be composed of one or more materials or membranes.
• Any combination of the nasal and mouthpiece can be composed of can be composed of one or more materials that allow the minimal or unimpeded inflow or air but create an increase in outflow pressure while allowing the egress of exhalent such as carbon dioxide or membranes. The nasal piece can consist of a nasal plug. The nasal piece can nasal covering; the nasal piece can fit into the nostril; can fit around the nostril or can be a combination of; fit into and around the nostril.
• In another embodiment, the nasal piece can create and airtight and watertight seal with the nostril or nose. The nasal piece can create and airtight and watertight seal with the skin of the nostril or nose but allow water or air to pass through the nasal piece. The nasal piece can be annular or non-annular or a combination of annular and non-annular. The nasal piece can be annular or non-annular or a combination of annular and non-annular and contain at least on conduit.
• The mouthpiece can be annular or non-annular or a combination of annular and non-annular. The mouthpiece can contain at least on conduit. The anchor or fixing of the nasal piece into the nostril or nose into the mouth or around the mouth or lips can include Tacky or a sticky or a non-tacky attachment that can include the inner nose or outer nose, pressure on the inner wall of the nostril, fixation band around all or a portion of the users head; connection to the mouthpiece; inside or around the ears; the eyes or a goggle or flexible or inflexible eye piece; a head cap or hat; the hair or moustache; a piecing through the skin or mucosa of the mouth or nose; to the teeth; to one or more teeth; which can be the upper palatine teeth or lower mandibular/buccal teeth or both which can include braces or denture-like or mouth guard or a molded fixation piece that conforms to the inner teeth, the outer teeth the biting surface, a combination of the above, the gums or a combination of the gums and teeth.
• In another embodiment regulating the humidity of the user's internal and external body environment. Can be used with for respiratory needs to include CPAP for assisted ventilation needs, assisted ventilation that requires a full or partial seal of a respiratory orifice, measurement of gases or water/humidity. Athletic training or events, improve or assist or measure respiratory function. The device can utilize an air detector that can measure gases to include carbon dioxide, oxygen, and nitrogen. The device can utilize a vapor or water detector that can measure water vapor and humidity. The device can use a gas delivery system that can deliver gases to include oxygen. The device can use a gas delivery system that can remove gases to include carbon dioxide. The device can use a gas exchange or removal system that can exchange gases to include the delivery of oxygen and the removal of carbon dioxide. The device can use an internal device integrated into the breathing mask or external machine that produces negative, positive or neutral or a combination of negative, positive or neutral airway pressure device.
• The mouthpiece can be a gel or an airtight membrane that surrounds the teeth and/or gums. The mouthpiece can be anchored to the teeth by a mouth-guard that is molded to the gums and, a mouthpiece molded a component of the teeth. The mouthpiece can be a combination of the above. The mouthpiece can be a breathable membrane. The breathable membrane can be made to have variable pores or fenestrations or can be made of a machine can utilize an oscillating or variable airflow or pressure; a non-oscillating or non-variable airflow or pressure or a combination of variable and non-variable airflow or pressure.
• The CPAP machine can vary its air delivery based on gas sensors such as oxygen and carbon dioxide. The CPAP machine can deliver oxygen to the user. The CPAP machine can extract carbon dioxide. In one embodiment uses for the CPAP mask can include treating premature infants with respiratory challenges that can include IRDS, TTNB, wet lungs or infection; adults with ARDS, pneumonia, wet lungs, volume overload, emphysema, or non-human living beings that require assisted ventilation.
• One preferred embodiment can use a gel seal that surrounds the eyes and has a skin covering material a portion that is overlying the eyes and is transparent and a component that is made of a designer fabric that acts as a Zorro-like mask the mask fits around the back of the head or around the ears or a combination of the back of the head or the ears.
• In another embodiment, the eye goggles or mask can be one continuous flexible material, which can include a gel that can include a gel that varies in hardness and softness and transparency.
• In another embodiment, the eye goggles or mask can be one continuous flexible material with a separate lens. The goggle can include a gel that can include a gel that varies in hardness and softness and transparency.
• In another embodiment, the eye goggles or mask can be one continuous flexible material with a separate lens and a separate sealing pad. The goggle can include a fabric a plastic or polymer or gel that can include a gel that varies in hardness and softness and transparency.
• In another embodiment, the eye goggles or mask can be one continuous flexible material with a separate sealing pad. The goggle can include a fabric a plastic or polymer or gel that can include and can include a gel that varies in hardness and softness and transparency.
• In another embodiment, an eye goggle can incorporate a viewer that can include viewing objects more clearly or seeing laterally or behind is useful. The viewer can be an electrical device that can include a camera and viewing device that can include a screen, a direct retinal projection or a projection onto the lens of the eye goggle or mask; or at least on lens or mirror that is incorporated onto the goggle that can serve like a periscope-like apparatus, a wide or narrow angle lens that can include at least a portion of the goggle or lens. Uses for this eye goggle or mask can include scuba diving, where seeing the fish laterally or close up or behind can be useful, competitive racing where seeing the competitors laterally or behind in the adjacent lanes can be useful.
• Another embodiment can include a eye goggle or mask that is a viewing screen that is used with a device to include a medical process that will allow the device user to be able to continuously view the patient and not have to turn their head to view a screen on the machine.
• In the preferred embodiment, the medical machine would include but would include an Ultrasound machine. The Sonographer can wear a pair of viewing eye goggles or a mask or glasses that can project the ultrasound image onto the glasses while the Sonographer is scanning the patient. Currently the Sonographers have to continuously turn their heads to the ultrasound device and back to the patient. Sonographers are prone to develop herniated discs and degenerative diseases in their necks and spasms and muscular difficulties in their shoulders. The method of the transmission of the ultrasound signal from the machine to the eye viewing devise can include wires, wireless, optics or other means of transmission electromagnetic signals.
• Other uses for medical eye viewing devices can include robotic surgery, angiography and catheterization procedures, endoscopy and medical and surgical procedures that require ancillary screen viewing.
• In another embodiment, eye goggle or mask viewing devices can be combined with a sealing pad and a skin covering material to be used in a surgical field or in an emergency field or battlefield or in a situation where toxic or infectious or dangerous biologic or non-biologic agents are present and there is a need to view a screen and keep attention focused on a task in a viewing plane different than a viewing screen and where a part of the body to include the eyes, nose or mouth or an opening or cavity in the superficial skin needs to be protected.
• In another embodiment, the sealing pad or a sealing pad with a skin covering material can contain a material within the gel sealing pad to include a solid or liquid or gas or another gel. This embodiment can be used for an ear plug, nose plug, intubation device, anal or vaginal device for a seal in which to create greater buoyancy, for delivering substances to include medication, gas, detoxifying agents, or to serve as acoustic reflectors or absorbers, or to alter the cushioning or the hardness or softness of the gel.
• In the preferred embodiment, a sealing pad or a sealing pad with a skin covering material can be used as an earplug in which the sealing pad or the sealing pad with a skin covering material contains an acoustic absorbing or reflecting material that can include a solid, liquid or a gas or another gel or a combination of these elements, which be used to reduce noise in an environment in which noise reduction is desired. The earplug can contain at least on conduit or channel or tube that can transmit or contain a solid, liquid or gas.
• In one embodiment the a sealing pad or a sealing pad with a skin covering material can be used as an earplug in which the sealing pad or the sealing pad with a skin covering material contains an acoustic absorbing or reflecting material that can include a solid, liquid or a gas or another gel or a combination of these elements, which be used to reduce noise in an environment in which noise reduction is desired can be an acoustic delivering device to include a speaker. In another embodiment it can be a delivery device to deliver a gas or medication.
• In another embodiment, a sealing pad or a sealing pad with a skin covering material can be used as a detoxifying agent in a sealing pad that is used for an isolation suit in which the sealing pad or the sealing pad with a skin covering material contains a detoxifying agent for absorbing or reflecting toxic materials and the detoxifying agent can include a solid, liquid or a gas or another gel or a combination of these elements, which can include activated charcoal or chelating agents to include dimercaptosuccinic acid (DMSA). 2,3-dimercapto-1-propanesulfonic acid (DMPS) and alpha lipoic acid (ALA), which be used to reduce toxins to the body in an environment in which toxin reduction is desired.
• All of the designs of sealing pads and skin coverings and fixation devices and anchors and flanges and indicators and reservoirs and delivery methods and eye viewing devices and all other methods described herein can be used alone or in combination to include and uses as a wound cover to include a bruise, laceration, burn, surgical site or site of trauma either natural or animal or man-made; a cast cover a breast cover or pump, a mask, a breathing mask that can include a CPAP or BIPAP or positive pressure ventilation mask, an untubation device, goggles, eyewear, nose pieces or nostril plugs or devices, earpieces or earplugs or ear-buds, hand covers or gloves, garments, clothing, shoes, socks, a condom catheter or urinary processing device to include a urine bag, a semen processing device to include a male condom, a female condom or a male or female contraceptive device, a diaper or fecal processing device to include an ostomy bag. environmental suit or environmental protective gear, and a medication delivery system that requires areas of the body or skin that are preferentially treated with areas of medication delivery that have spaces or gaps between the sites of medication delivery and can include all other applications and related applications described herein, as well as applications that are derivatives of the applications described herein.
• In one embodiment the sealing pad, fixation device, anchoring device and skin covering material or any combination of these elements can be composed a material to include a gel or solid that has the ability to alter its physical properties to include but not restricted to its hardness and softness, its thickness or length or width, its coefficient of friction, or its repair capabilities, or any combination of these properties. In one embodiment the sealing pad, fixation device, anchoring device and skin covering material or any combination of these elements can be composed a material to include a gel or solid that has the ability to alter its hardness or softness or thickness or any combination of these properties using a method or device to include a heating or cooling unit, or a reservoir, or can have impregnated materials that can be a solid or liquid or gel or gas and can be formed from a material to include an elastomer to include a thermoplastic elastomer, gel, rubber, latex, and metals polymer and alloy materials to include temperature-responsive polymers which are materials which undergo changes upon temperature changes, smart metals to include Nitenol and shape memory alloys and non-metal shape memory polymers in which large deformation can be induced and recovered through temperature changes or stress changes and martensitic phase changes, piezoelectric materials that produce a voltage when forces or stress are applied resulting in structure altering shape to include bend, expand or contract when said voltage is applied, shape memory alloys and shape memory polymers which can have large deformations which can be induced and recovered through temperature changes or stress changes (pseudoelasticity), magnetostrictive materials which can change in shape under the influence of a magnetic field and can exhibit a change in their magnetization under the influence of mechanical stress, magnetic shape memory alloys which are materials that change their shape in response to a significant change in a magnetic field, pH-sensitive polymers which are materials that change in volume and shape when the pH of the surrounding environment changes, halochromic materials which can change their color as a result of changing acidity which can also be used as indicators to include condoms which can include a sensor to detect a breech in the condom integrity or intubation devices to include a sensor to detect whether gastric reflux or aspiration has occurred or wound covers that can include detect infectious agents that change the pH of the wound to include bacteria, fungi, viruses and other infectious pathogens, chromogenic systems which can change color in response to electrical, optical or thermal changes which can include electrochromic materials, which change their color or opacity on the application of a voltage to include liquid crystal displays, thermochromic materials change in color depending on their temperature, and photochromic materials, which change color in response to light, ferrofluids, photomechanical materials change shape under exposure to light, self-healing materials have the intrinsic ability to repair damage due to normal usage, thus expanding the material's lifetime, dielectric elastomers (DEs) are smart material systems which produce large strains under the influence of an external electric field, magnetocaloric materials are compounds that undergo a reversible change in temperature upon exposure to a changing magnetic field, Thermoelectric materials are used to build devices that convert temperature differences into electricity and the reverse.
• Some embodiments include a head cooling device that can be worn over the head whose use is to treat body to include brain or biologic or physiologic conditions that can include overheating during warm weather, heat stroke, febrile seizures, muscle cramping, hair loss, heart disease and respiratory disease and renal diseases; and psychiatric disorders to include anger or rage or anxiety, suicide, depression, schizophrenia, memory and mania and other biological and psychiatric conditions thought to be caused or felt to be caused or exacerbated by excess body or brain heating, conditions that would benefit from body or brain cooling or slow body or brain metabolism to include ischemic stroke, seizures, brain tumor growth. In one embodiment the cooling device can be composed of a sealing pad, skin covering material, fixation device, anchoring device and indicators or feedback device or any combination of these elements.
• Incorporated into this device is a cooling device that can include a solid of liquid or gas or gel material that can be used to interface with the sealing pad which can be airtight and water tight but does not have to be airtight or watertight. Methods of cooling can include conduction which can include direct transfer of heat through cooling devices to include cooling tubes conduits or channels that can contain water, Freon, thermoelectric cooling, or vapor compression cooling; or convection which can include fans, blowers impellers, and evaporation which can include refrigeration and fan and air-conditioning like devices. In one embodiment the cooling head cap is composed of a sealing pad that can include a gel or a non-gel that can form an airtight or watertight seal with at least a portion of the user's head or neck to form an isolation chamber. In the preferred embodiment the seal is a gel seal.
• In some embodiments, the isolation chamber is created such that there can be a liquid or gel or a gas or solid or combination of these elements that passes between the user's skin which can include the scalp, face or neck and torso and serves as a means of removing heat or transferring heat away from the user's brain. In one embodiments some orifices or some given body parts can be kept separate from the isolation chamber and these body parts can include a body that can include the user's mouth and nose and ears or torso such that these body parts can be sequestered from the remainder of the isolation chamber by additional sealing pads or isolation chambers. There can be zero or one or more than one isolation chamber used for the head cooling device. There can be one or more than one isolating chambers that affect and effect cooling. In another embodiment sealing pads or isolation chambers can be used to isolate body parts that contains sensors or feedback devices or surgical areas of intervention and in which the material that can include solids, liquids and gels and gases between the user's skin and the cooling device is isolated and sequestered from the actual cooling portion of the head cooling device.
• In other embodiments, the gel sealing pad can contain methods or transferring heat away from the body that can include conduction, convection or evaporation. These embodiments can be used alone or in combination. Sensors and feedback units can be used to monitor and feedback control of physiologic and biologic functions to regulate core body and brain temperature. There are some brain functions to include febrile seizure and ischemic stroke that can benefit by reducing oxygen and metabolic requirements of the brain more than other body parts.
• Other embodiments include a head warming device that can be worn over the head whose use is to treat the body or body parts to include brain or biologic or physiologic conditions that can include overheating during warm weather, hypothermia, hair loss, and psychiatric disorders to include depression, memory and other biological and psyschiatric conditions thought to be caused or felt to be caused or exacerbated by excessive body or brain cooling, conditions that would benefit from body or brain heating or more rapid body or brain metabolism to include warming from hypothermia, brain tumor growth to include during chemotherapy. In one embodiment the heating device can be composed of a sealing pad, skin covering material, fixation device, anchoring device and indicators or feedback device or any combination of these elements. Incorporated into this device can be a heating device that can include a solid of liquid or gas or gel material that can be used to interface with the sealing pad which can be airtight and water tight but does not have to be airtight or watertight. Methods of cooling can include conduction which can include direct transfer of heat through heating devices to include heating tubes conduits or channels that can contain water, thermoelectric heating, or radiator-like warming devices; radiant heating or convection which can include heated substances through fans, blowers. In one embodiment the heating head cap is composed of a sealing pad that can include a gel or a non-gel that can form an airtight or watertight seal with at least a portion of the user's head or neck to form an isolation chamber.
• In the preferred embodiment the seal is a gel seal. In some embodiments the isolation chamber is created such that there can be a liquid or gel or a gas or solid or combination of these elements that passes between the user's skin which can include the scalp, face or neck and torso and serves as a means of adding heat or transferring heat toward the user's brain. In one embodiments some orifices or some given body parts can be kept separate from the isolation chamber and these body parts can include a body that can include the user's mouth and nose and ears or torso such that these body parts can be sequestered from the remainder of the isolation chamber by additional sealing pads or isolation chambers. There can be zero or one or more than one isolation chamber used for the head warming device. There can be one or more than one isolating chambers that affect and effect cooling. In another embodiment sealing pads or isolation chambers can be used to isolate body parts that contains sensors or feedback devices or surgical areas of intervention and in which the material that can include solids, liquids and gels and gases between the user's skin and the cooling device is isolated and sequestered from the actual cooling portion of the head cooling device.
• In other embodiments the gel sealing pad can contain methods or transferring heat toward the body that can include conduction, convection or radiation, radiant heat. These embodiments can be used alone or in combination. Sensors and feedback units can be used to monitor and feedback control of physiologic and biologic functions to regulate core body and brain temperature. There are some brain functions to include febrile seizure and ischemic stroke that can benefit by reducing oxygen and metabolic requirements of the brain more than other body parts. Some brain functions to include hypothermia, depression and tumor sensitivity during chemotherapy can benefit by increasing oxygen and metabolic requirements of the brain more than other body parts. Heating and cooling of the brain may have changing benefits depending on tissue and brain sensitivity during treatments to include tumor treatment and psychiatric conditions.
• The heating and cooling body part devices can be utilized on just the head or on the head and neck region for greatest effect on the brain and body but these devices are not isolated to the head and neck and can be used on other body parts to include the torso, appendages and internal organs using the sealing pad, skin covering material, fixation device, anchoring device and indicators or feedback device or any combination of these elements described herein.
• These heating and cooling devices can be used to include treatment for treating peripheral vascular disease, Raynaud's disease, diabetes, and neuropathies and can be used to treat and provide symptom relief for sensory discomfort. These devices can be used for providing pleasure and can be used on appendages to include the penile and vaginal and anal regions for sexual pleasure and to improve sexual function to include erectile function, orgasm, and sexual pleasure and stimulation. These devices can be used for relieving pain and discomfort and can be used on appendages to include the arms and legs and anal regions and can be combined with other devices to include vibrational and ultrasonic devices and substances that can invoke sensory responses.
• Another embodiment of a gel sealing pad is a gel sealing pad that can incorporate gel within a portion of a foam material that can include standard and memory foam which can include the gel incorporated into at least a portion of foam and can include surrounding the foam or insinuating gel within the inside of the foam or into the interstices of the foam.
• Some embodiments include a sealing pad for interfacing with a body surface. The sealing pad can include a pad, a first perimeter flange projecting from the pad and sealably contacting the skin and having a contour, and a second perimeter flange projecting from the pad spaced apart from the first perimeter flange and sealably contacting the skin and having a contour. The sealing pad can further include end portions extending from the pad and sealably contacting the skin, wherein the end portions, the first perimeter flange, and the second perimeter flange, the pad, and a portion of the skin define a space. The sealing pad can also include an internal flange projecting from the pad between the first and second perimeter flanges and sealably contacting the skin and having a contour, wherein the first perimeter flange, the internal flange, and the second perimeter flange together define a redundant seal between the pad and the skin.
• Further embodiments include a fixation device comprising a web of strands configured to encircle a portion of a human body. The strands cover a portion of the human body beneath the strands and can define spaces between the strands through which a portion of the human body is exposed. At least some of the strands are made of a gel material.
• Still further embodiments include a method for positioning a fixation device relative to a human body. The method can include positioning a fixation device comprising a web of strands over a portion of a human body, wherein the strands cover a portion of the human body beneath the strands, and wherein the strands define spaces between the strands through which a portion of the human body is exposed. At least some of the strands are made of a gel material. The method can also include positioning a seal member over a portion of the human body, wherein the seal member is connected to the fixation device, and wherein the seal member has an envelope extending from the sealing member and defining a space in fluid communication with the human body sealed by the sealing member, and administering a substance to or removing a substance from the human body within the envelope.
• Other embodiments of the present invention include an annular seal for a skin covering, the seal comprising a first portion having a first radius, a proximal portion and a distal portion, and a second portion having a second radius greater than the first radius. The second portion having a proximal portion and a distal portion, wherein at least one of the first, second, and end portions are generally elastic, and wherein at least one of the first, second, and end portions are made of a gel material. The annular seal can include an end portion extending between the first portion and the second portion at the proximal portions of the first and second portions, wherein the first portion, the end portion, and the second portion define a generally U-shaped cross section. The annular seal is configured to receive a portion of a human body with the first portion being inward of the second portion, and the distal portion of the first portion is thicker than the proximal portion of the first portion to define a first projection. The distal portion of the second portion is thicker than the proximal portion of the second portion to define a second projection. The end portion, the first projection, and the second projection are configured to receive a skin covering between the first projection, the second projection, and the end portion to resist withdrawal of the skin covering from the annular seal. The embodiments described herein can be used with an organism that can be human and non-human.
• The preferred embodiment for a female urinary catheter can include a gel sealing pad surrounding the urethra. Attached to the sealing pad is a skin covering which has a bag shape that is designed to collect about 200 cc of urine with a conduit or tube at its end, which will divert the urine away from the body and the proximal urinary bag. There would be a one-way valve at the opening of the tube, which would allow fluid to flow away from the body and not toward the body. The gel sealing pad will create a watertight seal around the urethra. Attached to the gel pad is an anchoring device that would be made of a semi-solid gel that conforms and fits into the vagina in a manner reminiscent of a tampon. Also attached to the sealing pad and the anchor is a web-like gel fixation device that conforms and surrounds the vaginal region. The fixation device in the preferred embodiment is attached to a garment that is in the form of a bikini or undergarment or thong or a straps that surrounds both waist and the outer buttocks.
• In the preferred embodiment a breast pump is configured to simulate the suction and motion of the mother's infant breastfeeding. To accomplish this the sucking motion of the infant is codified and determined by having the infant suck on a simulated-nipple that can simulate a mother's breast. Sensors are placed in and on the simulated-nipple and the suction and motions of the infant are recorded for an extended period of time and the information is transferred to a computer that can capture and store this information. When the mother is ready to pump her breasts, the computer information can be transmitted to the breast pump and the mother's breast pump sealing pad and the suctioning device of the breast pump. The computer signal will then reproduce from the stored information a simulation of the infant's suction and sucking motions. In some embodiments the scent of the infant or pheromones can be released to stimulate the mother's let down reflex that starts the flow of milk. The computer can analyze maternal breast milk parameters to include but not restricted to the interval prior to milk let down, the quantity of milk and breast characteristic such as temperature in order to determine the best simulated infant sucking program. This process can be used for but not restricted to newly nursing and breastfeeding mothers or infants or mothers or infants who are benefited by the program. The same or a variation on the same or similar device can be used to teach newly nursing infants to nurse better and can be used when an infant is transitioning from breast to bottle-feeding nipples.
• Fixations methods can include but are not restricted to two methods that include overlapping strands and a weave. The first method and structure can include but is not restricted to stands that can be overlapping or non-overlapping and which in the preferred embodiment can include but are not restricted to a gel material that can include but is not restricted to a tackifying material or an adhesive or which can be naturally tacky or: a fabric-like material that can include a microfiber with a high coefficient of friction and increased drag on the skin when the material when a force to include but not restricted to pulling is exerted. When said force to include but not restricted to pulling is exerted on the fixation device, the portions of the fixation in contact with the skin exert an increased coefficient of friction or drag that can increase or accumulate the more the fixation device is pulled upon. This embodiment is based at least in part on an increase in the surface area of the high coefficient material that is in contact with the skin. This represents both a method and a device. A second method and structure and embodiment of the fixation can include but is not restricted to a fixation device that is in the shape to include but not restricted to a weave that can include but is not restricted to resemble the weave of a Chinese Finger Puzzle. The weave when exposed to a force to include but not restricted to a pulling force will tighten in some areas and not in other areas. The weave when exposed to a force such as pulling will tighten and narrow the diameter of the fixation device and constrict around the body part to which it is in contact. The fixation device can be associated with but not restricted to a sealing pad and a skin covering material and an anchoring device and method.
• The fixation device can be formed from a high coefficient of friction material that at least a portion of the fixation device can include a gel that can include but is not restricted to a tackifying material or an adhesive or which can be naturally tacky; or a fabric-like material that can include a microfiber with a high coefficient of friction and increased drag on the skin.
• In the preferred embodiment of the cast cover is composed of a waterproof skin covering material and an annular gel sealing pad which is tacky and elastic can be formed so that when it is in its resting or relaxed state it is approximately the same circumference or very slightly less circumference than the user's appendage. The gel sealing pad will have the ability to stretch to many times it's resting and will be resiliently deformable such that the sealing pad will return to its resting circumference. This will allow the sealing pad to easily fit over the appendage or a structure or device associated with the appendage to include but not restricted to a cast, a wound cover, a central intravenous or arterial catheter in a manner that the skin of the appendage or the structure or device associated with the appendage is not damaged. The sealing pad can be placed over the distal aspect of the appendage, which for example may be the fingers of the hand and arm. One place comfortably over the distal aspect of the appendage the sealing pad can be positioned over the appendage and the structure or device, which can include but is not restricted to a cast, until the sealing pad are proximal to the cast and rest comfortably on the proximal skin with the sealing pad lying flat against the skin. Once the sealing pad is in place a waterproof skin covering material can be placed into position. If the sealing pad is to be used for a distal arm cast then there will be an open end of the waterproof skin covering material and a closed end. The open end will be place over the fingers first and positioned in a similar manner such that it rests in the middle aspect of flat sealing such that the distal half portion of the sealing pad is covered by the waterproof skin covering material while the proximal half portion of the sealing pad is not covered by the waterproof skin covering. Next the distal half portion of the sealing pad is folded cover the proximal half portion. This creates a sealing pad with a C shape such that the distal half of the sealing pad forms a watertight seal with the skin; the waterproof skin covering material is wedged between the proximal and distal halves of the sealing pad in a manner that the sealing pad forms a waterproof seal with the skin covering material on side of the skin covering material that is both interior and exterior or closest and farthest to the skin. The proximal half portion of the sealing pad is now external to the distal half portion and rests on the distal half of the sealing pad and creates a gentle compression on the distal half of the sealing pad that is creating and airtight and watertight seal and this gentle compression further assists with creating the airtight and watertight seal. In the preferred embodiment the open end of the skin covering material will be wider than the remainder of the skin covering material and will serve as a bulbous end portion that can serve as a male end or protuberance or bulbous insinuator. The sealing pad can have a groove or female invagination. When the sealing pad is folded over the skin covering's male bulbous end portion will insinuate itself into the female invagination or groove of the sealing pad and create a lock and key like mechanism for the sealing pad and the skin covering material. The sealing pad can include but is not restricted to being folded more than or less than in half. The locking mechanism can include but is not restricted to multiple shapes to include geometric shapes that are more or are less resistant to tugging or disengaging. The skin covering can have more than one opening especially when the skin covering is place such that it is important for the middle portion of the body part or appendage to be covered but a proximal and distal portion of the body part is to remain uncovered. One example of this can include a PIC line that is placed in the antecubital region near the elbow and the shoulders are uncovered and it is desirable to have the hands uncovered so that the hands can be without a covering to be used freely. Waterproof can mean airtight and watertight. Although the sealing pad in the preferred embodiment is singular and flat and is folded over only one, less than or more than one folding or molded forms of the sealing pad can be used and more than one sealing pad can be used. The skin covering can have bulbous ends or can be flat or have invaginations. The sealing pad can have bulbous ends or can be flat or have invaginations. The sealing pad can have a different radius that varies from distal to proximal.
• The fixation device can be annular or circumferential or non-circumferential. The fixation device can be used with another material to include but not restricted to fabrics. The fixation device can be used to engage a substantial portion of the user's skin. The definition of substantial can vary widely because each application or use varies to include but is not restricted to use as a female condom catheter or a male condom catheter or an ostomy bag or a device holder; and because each body part to be engaged varies to include but is not restricted to use on the and body parts to include the penis, the vagina, the arm and the torso; and because each organism varies and can be of a different size and shape and form and hairiness and because the fixation device can be used on human and non-human organisms and the weight that the condom catheter must tolerate. Optimally for the penis when used with a condom catheter with a sealing pad and skin covering then an annular fixation device that engages the penis can engage to include but is not restricted to a minimum of one-third of the flaccid penile length that may constitute the minimal desirable definition of substantial but this is not a fixed amount and can vary to include more of or less than that amount of substantial engagement and can change based on the tackiness and friction of coefficient of the gel and based on how tightly the fixation annular is engaged, and whether the penis is dry or wet, or whether the gel is used with microfibers that resist wetness and whether the urine bag attached is empty or full In another embodiment if the fixation device is used as a contraceptive or disease preventing condom substantial can include but is not restricted to be as small as ten-percent of the erect length of the penis and the percent of engagement can vary upward or downward depending on factors that include but are not restricted to the tumescent nature of the penis, the tightness of the fixation device on the penis and whether the device is place onto the penis in a dry or a whet state. In another other embodiment the fixation device can be used with a female condom catheter which can be non annular and lie flat against the skin and substantial can be defined as covering a portion of the vaginal ring and can engage an amount to include but not restricted to as small as a semi-circle about the more caudad portion of the vagina allowing and this can vary on the users desire and comfort with having the opening of the vagina to remain free of a fixation device to reduce irritation \ to the labia or can be dependent upon whether an anchoring device similar to a tampon in the vagina is used with the fixation device. Another variation on substantial can include whether the placement of the fixation device on the arm to hold an electronic device such as an iPod. In this embodiment the fixation device can be used with a stretchable fabric and in this case as little as to twenty percent of the annular fixation device may need to be the gel fixation component and will vary on parameters to include but not restricted to the tightness on the arm, the vigorousness of the exercise or body function and the amount that an individual sweats.
• The application of the term substantial can be applied to other devices herein this application to include but not restricted to the sealing pad and the anchoring device.
• The fixation device can be used in both a dynamic and a non-dynamic or static state and the portion and part of the user's body that are in contact with the gel or high coefficient of friction material and the user's skin. In each of these states and circumstances there are a range of forces acting upon the gel and the skin. One embodiment can include a flaccid penis and a static state with a dry environment where the forces are primarily the constrictive forces in a perpendicular plane relative to the penis and tackiness or coefficient of friction and the surface area of the skin to fixation device ratio. In another embodiment the fixation device can be used with a condom catheter that is being pulled with a force that is in alignment with the penis and parallel to the fixation device. In this embodiment the forces on the gel and the skin of the penis become more complex. The pulling force on the gel creates a vector force that has components that are both parallel and perpendicular to the penis. The surface area varies and in regions increases when the gel strands are more condensed and in other areas my decrease when the gel strands are more attenuated. Additionally the gel can constrict on the penile skin and create a vector that is predominantly perpendicular to the penis and exerts compression on the penis and the gel or high coefficient of friction material. The application of the forces can be applied to other devices herein this application to include but not restricted to the sealing pad and the anchoring device.
• All of the designs of sealing pads and skin coverings and fixation devices and anchors and flanges and indicators and reservoirs and delivery methods and eye viewing devices and all other methods describer in this patent can be used alone or in combination to include but are not restricted to uses as a wound cover to include but not restricted to a bruise, laceration, burn, surgical site or site of trauma either natural or animal or man-made; a cast cover a breast cover or pump, a mask, a breathing mask that can include but is not restricted to a CPAP or BIPAP or positive pressure ventilation mask, an untubation device, goggles, eyewear, nose pieces or nostril plugs or devices, earpieces or earplugs or ear-buds, hand covers or gloves, garments, clothing, shoes, socks, a condom catheter or urinary processing device to include but not restricted to a urine bag, a semen processing device to include but not restricted to a male condom, a female condom or a male or female contraceptive device, a diaper or fecal processing device to include but not restricted to an ostomy bag. environmental suit or environmental protective gear, and a medication delivery system that requires areas of the body or skin that are preferentially treated with areas of medication delivery that have spaces or gaps between the sites of medication delivery and can include but are not restricted to all other applications and related applications described in this patent, as well as applications that are derivatives of the applications described in this patent.
• FIG. 1 is a sagital view of theusers skin1 and asealing pad2 with askin covering3, which is interposed between the user'sskin1 and thesealing pad2 and which uses at least oneflange4, which is used to include contour and form an airtight and watertight seal with theusers skin1.
• FIG. 2 is a frontal view of asealing pad2 with askin covering material3, in which theflanges4 can include varying shapes and sizes and thicknesses and elasticity.
• FIG. 3 is a sagital view of asealing pad2 andskin covering material3, which can include at least oneflange4 that can be on the surface away from theskin1 to serve as a wall or barrier and can deflect5 solids or liquids or gases to include inhaled or exhaledgases6. Theflange4 serves as a barrier which can include form an airtight and watertight seal with at least a portion of the user'sskin1. This embodiment includes asurgical mask3 that can include a flat gelsealing pad cushion2 that lies against theskin1, and aflange4 that serves as a wall or barrier that lies on the surface of thesealing pad cushion2 that is spaced apart from theskin1 and deflects exhaled gases andhumidity7 away from abody part8, such as the eyes. Themask3 can contain vents or valves or humidity or air absorbing substances to vent air out of or into the environment between thesealing pad2 and theskin covering3 and the user'sskin1 and a portion of a user'sbody8 such as the eyes. Thegelatinous elastomer pad2 may be used as a cushion or seal or pad and covering material that is used for a breathing mask. The breathing mask can be used for a continuous airway pressure (CPAP) mask and non-continuous positive airway pressure or alternating degrees of positive airway pressure or negative airway pressure or basic gas exchange.
• The present breathing mask can be used for an environment protection mask, isolation mask, surgical mask, anesthesia and gas delivery mask, scuba and liquid submergence mask, a scent and smell delivery mask, a gas exchange mask, a fluid exchange mask that can be used for liquid delivery that facilitates ventilation, a pressure exchange mask, a pressure equalization mask, a cardio-pulmonary resuscitation (CPR) mask and a respiratory ventilation assistance mask to include active and/or passive assisted pulmonary ventilation. The sealing pad and the related devices and augmentations can be used with the sealing pad can be used for intubations. The dimensions and materials of the mask can be varied depending on the intended application of the mask. For example, for more potentially dangerous applications such with a hazmat suit, the mask can includemore flanges4 having more varied contours.
• The seal of the mask in the preferred embodiment is composed of gel, which can create an airtight and watertight seal with theskin1. Thegelatinous elastomer pad2 may be used alone or in conjunction with non-gel materials and thepad2 can be a non-gel material or a combination of gel and non-gel material. The seals can include gels, Thermo Plastic Elastomers that can include Cyberskin, Silicon, Polystyrenes, Polystyrene and oil mixtures, and latex rubbers to include jelly rubber. The mask can include a frame to support some portion of the mask, and can utilize flexible materials for the frame and attachment and coveringmaterials3 andflanges4. Other embodiments could include hardened material for the frame but these would be positioned to minimize discomfort to the user.
• Thesealing pad2 may be affixed to theskin covering3. In one embodiment the fixation can be through integration of the gel into the material of the sealing pad and/or the skin covering, or through an adhesive material. Thesealing pad2 may be separate, detachable, from the skin covering3 so that it can be replaceable. The skin covering material can be flexible or semi-flexible or rigid.
• Theflanges4 of thesealing pad2 may be composed of projections that can vary in shape and serve asflanges4, walls, or valves that form an airtight or watertight seal with theskin1. Theflanges4 can have geometric shapes or non-geometric shapes. Theflanges4 can form an airtight seal in some sections and be non airtight in others allowing for breathability of theskin1. Theflanges4 can be constructed to follow or adjust to the contours of abody part1. Thebody part1 can be superficial or can be internal. For example, thebody part1 can be in a cavity or organ, on the skin, within the skin layers or deep to the skin within the organism. The seal between thepad2 and theskin1 can be annular (forming a complete and closed envelope) or the seal can be partial or non-annular.
• Theflanges4 can be all oriented in the same direction or in opposing directions. Theflanges4 can be one row or multiple rows. The flanges can be oriented to create a variable pattern that can create a watertight seal and can better conform to the user's skin contours. Theflanges4 can be created such that the flange composed of gel or non-gel has an endoskeleton. The seal between theflanges4 and theskin1 can be one or more continuous or discontinuous sections that can be circumferential or non-circumferential, which can also be spiral or overlapping. Theseal flanges4 can be one or more non-continuous pieces of material that can be circumferential, with the ends of each piece overlapping, or with the ends of each piece having a transition piece that serves as an attaching or fastening element.
• In one embodiment, the mask can include a source of positive or negative pressure within the mask to improve the seal between theflanges4 and theskin1. The pressure can be created by an external circumferential or non-circumferential material. The seal can have the seal improved by one or more expandable chamber that contains a gas, liquid or solid. The expandable chamber can lie external to the circumference of the seal. The expandable chamber can lie within the seal. The expandable chamber can lie between the skin and the seal or can be a combination of chamber locations.
• In another embodiment the gel seal can be a material that when expanded is resiliently deformable and returns to its original size. In another embodiment the seal can return to a size larger than its original size or to a size smaller than its original size.
• FIG. 4 is a front view of asealing pad2 withflanges4 and askin covering material3 which can be coated or impregnated with a substance or medication. The use of the delivered substance orenergy9 which can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying age or filter, heating or cooling, gas delivery, liquid or solid delivery. The substance can be activated or delivered to the user'sskin1 or the user'sbody part8 when activated by an activatingagent10 that can include a toxin, a temperature, a pressure, an organism, electromagnetic or kinetic energy or a substance such as a gas or liquid or solid activates the agent.
• FIG. 5 is a sagital view of asealing pad2 withflanges4 and askin covering material3, in which theflanges4 can be stacked or constructed to form a geometric shape that can have volume and can create a network and can include a pyramid, a hexagon, a pentagon, a cylinder, or a box or a honey-comb-like configuration.
• FIG. 6 is a front view of asealing pad2 with askin covering material3 with a fixation method that can be constructed in a geographic or non-geographic pattern that can be random or non-random that has spaces between the fixation method and the seal or the sealing pad and skin covering material to include a lace-like, web-like shape with alternating regions of sealing pad and absence of sealing pad such that the sealing pad can include and resemble a web, a web-like structure, a series of criss-crossed regions of seal and no-seal; a weave, a Chinese-finger puzzle configuration; curvilinear or circular patterns; and triangular patterns. The fixation method can have ajunction point12 with thesealing pad2 or theskin covering material3.
• FIG. 7 is a front view of afixation device11 that can include a gel that can include a pattern to include linear, curvilinear, crossing, criss-crossing, intersecting, and non-intersecting and non-criss-crossing or a weave or any combination of these methods and the pattern can include alternating regions of sealingpad2 and the absence of sealingpad2 can be referred to as a web or web-like pattern. Thefixation device11 can have multiple functions to include serving as asealing pad2 or making the sealing pad more breathable so that theunderlying skin1 is aerated and so that thesealing pad2 can be worn on theskin1 for extended periods of time; making thesealing pad2 more biocompatible so that the web-like sealing pad can move more freely with theusers skin1,body part8 or appendage; making thesealing pad2 more capable of staying in place or fixed or affixed to abody part8 by creating more than one region of attachment or friction or fixation; by making increasing the functional surface area of theskin1 to sealing pad and allowing for greater dynamic movement inbody parts8. Thesealing pad2 can be annular or non-annular or a combination of annular and non-annular. Thefixation device11 and thesealing pad2 can be circumferential or non-circumferential or a combination of circumferential or non-circumferential and at least a portion of thefixation device11 and the can be tacky or non-tacky.
• FIG. 8 is a front view of afixation device11 used with a condom catheter13. Thesealing pad2 can be annular and circumferential around the shaft of abody part8 to include thepenis8. Nearest the torso there is afixation device11 composed of gel and conforms to the movements of thepenis8. Distal to the torso the fixation method web-like sealing pad11 transitions into asolid sealing pad2 with a bulbous out-pouching14 that is annular and circumferential around the corona or transition point between shaft and head of the penis. The bulbous out-pouching14 fits snugly into the corona in circumcised male and in uncircumcised males can fit over the foreskin if un-retracted or on or near the corona if the foreskin is retracted. An alteration in the design can be adapted for uncircumcised males. The bulbous14 circumferential annular transition of the seal can continue as a gel sealing pad or can transition12 into theskin covering material3 that can have the form of a condom catheter of bag likeshape15 that is watertight and can have one or more conduits or tubes that can allow for the egress of urine away from the penis. In addition one of thetubes16 can deliver solids, liquids or gasses to the penis that can assist in the comfort or biologic function of the penis that can include delivering a drying agent to include dry air, silicon dioxide, powder, cornstarch, or an alcohol based solution or gel; a medication that can include an antibacterial, antifungal, or antiviral agent; a medication that can treat a disease or condition to include cancer, HIV or other viruses, skin conditions, and pleasure delivery stimulating or anaesthetizing agents.
• FIG. 9 is a frontal view in which thefixation device11 can include apattern17 that can be a crossing pattern, a web-like17 pattern, aweave17, or a spider-like configuration. Thefixation device11 can also have acurvilinear pattern18 or anon-crossing pattern19. Thefixation device11 can be used with asealing pad2 or a sealing pad and askin covering material3, which can be used with awound cover3 to dress a condition such as a bruise, laceration, burn, surgical site or site of trauma either natural or animal or man-made, a cast cover a breast cover or pump, a mask, goggles, eyewear, nose pieces or nostril plugs or devices, earpieces or earplugs or ear-buds, hand covers or gloves, attach or be integrated into a garments orclothing20 to include shorts, under garments, pants, shirts, shoes, or socks. The device can be used with a condom catheter or urinary processing device to include a urine bag, a semen processing device to include a male condom, a female condom or a male or female contraceptive device, a diaper or fecal processing device to include asealing pad2 to seal anostomy site21. Thesealing pad2 can be used with an environmental suit or environmental protective gear and a medication delivery system that requires areas of the body or skin that are preferentially treated with areas of medication delivery that have spaces or gaps between the sites of medication delivery.
• These alternating patterns of sealingpad2 can be uniform in frequency of the pattern or can be more frequent at one end of the web of the pattern than at the other end. The seal can be used to anchor or fix the pad or the skin covering material or the device to parts of an organism's body to include the appendages, penis, vagina, internal organs, torso, neck, head, ear, nose, mouth. In the preferred embodiment, theseal pad2 having one or more of thepatterns17,18, or19 can be used externally or on theskin1 to include fixing and attaching a condom-catheter onto the penis or fix a cast or bandage or wound cover onto a body part to include an arm or finger. Other embodiments can include internal body use and can include fix and attach a covering material onto a body organ to include a kidney. ovary, uterus, or bowel.
• The web-like design can be used on non-living objects or substances to include two objects that need to be held in close approximation but require some separation and movement to include earphones and earbuds, or two objects that need to be closely bound to include two electronic communication devices such as an iPod and a cellular phone or earbuds to an electronic device.
• FIG. 10 is a frontal view in which the fixation method can include a fixation method that can be used with asealing pad2 or asealing pad2 and askin covering object22 to include adevice23 to include a user'sbody part8 to include a finger and sensing device to include a medical device to include a pulse-oximeter, glucose-meter or a blood saturation meter; or non medical uses to include a children's toy, a music device that attaches to the body to include an iPod or cellular phone attached to an arm. In the preferred embodiment thefixation device11 can be gel and can be placed around theupper arm8 and can have a pocket-like holder24 that can be water-proof. The pocket-like holder can hold amusical device23 that can include an iPod-like device23 that can be without a jacket or can have a waterproof jacket waterproof jacket or device covering material orpocket24 that is incorporated into thefixation device11 or the pocket-like holder24. This combination can be used for use in recreation to include swimming or surfing or playing in the sand, which can include beach volleyball or sun tanning.
• FIG. 11 is a sagital view of a molded or geometric shape formed sealingpad2, which can be gel or non-gel but in the preferred embodiment is agel sealing pad2. Thegel sealing pad2 can be folded upon itself so that the outer or external layer or layers25 of thesealing pad2 compresses theinternal layer26 to form a self-sealing external compressive force. Theskin covering material3 can be wedged between the outer or external25 andinner layer26 of thegel sealing pad2. Thegel sealing pad2 can also be folded upon itself so that theexternal layer25 compresses theinternal seal layer26 to form a self-sealing external compressive force that can be air-tight and water tight. Theskin covering3 can be wedged between the skin and the inner and outer layer of the gel seal. Theskin covering material3 will be attached to thesealing pad2 to form a substantially airtight and watertight seal to at least a portion of the seal or it can be non-attached and theskin covering material3 can be replaceable.
• FIG. 12 is a series of views of sealingpads2, which can be composed of one of more projections or folds that can be configured similar to the shape of the letter ‘E’ or ‘W’ or ‘N’ or ‘M’ or ‘C or ‘S’ or any combination of these shapes such that insinuation of thesealing pad2 and theskin covering material3 to form an airtight and watertight seal between theskin1 and thesealing pad2 and theskin covering material3. Thecompressive force27 can be created by the inherent structure of thesealing pad2 or by the folding of thesealing pad2 or by anexternal device23, which can include agarment20 to include a circumferential belt, strap or item of clothing or thefixation device11. Theskin covering material3 can contain a securing method or structure ordevice28 that can include bulbous projection or an invagination or a geometric or a random shape or an anchoring device to include Velcro, zip-lock, zippers, buttons, and pin-like projections that secure theskin covering material3 andseal2 in place. Thesealing pad2 can contain a securing method or structure ordevice29 that can include bulbous projection or an invagination or a geometric or a random shape or an anchoring device to include Velcro, zip-lock, zippers, buttons, and pin-like projections that secure theskin covering material3 andseal2 in place.
• FIG. 13 A is a frontal view andFIG. 13 B is a sagital view of a folded or moldedgel sealing pad2 can be used to hold askin covering material3 in place, and form a seal with at least a portion of theskin1 and, forms a barrier to include inhaled or exhaledgas6 and in one embodiment this can include abreathing mask2. Thesealing pad2 can have a C-shape folded or moldedattachment30 that arises thesealing pad2 or from theskin covering material3. In the preferred embodiment the folded or moldedattachment device30 also serves as a barrier orflange4 that is attached to an elongatedflat sealing pad2 that conforms to theskin1 of the user'sface8 flat cushion and forms a broad base that forms asubstantial sealing pad2 that interfaces with theskin1 while the C shape barrier orflange4 acts as a barrier to the exhaled or inhaledgas6 and also serves as an investing or coupling or holding or fixation or invaginating or attachingstructure30 for and to include abreathing mask3 which can include asurgical mask3. Theskin covering material3 can include can include anattachment securing method28 and thesealing pad2 and the folded or moldedattachment30 can include asealing pad2 or a folded or moldedattachment30 securingmethod29. In the preferred embodiment the mask can be removed and theskin covering mask2 can be replaced or theskin covering mask2 can be permanently or semi-permanently attached to thesealing pad2 and the folded or moldedattachment30 using methods to include adhesives, tackifying agents, pins, Velcro, Ziplocks, buttons and zippers. The folded or molded attachment can haveinvaginations31 and protrusions orprojections32 or a combination ofinvaginations31 and protrusions orprojections32.
• FIGS. 14 A and B depict a sagital view of a method for securing asealing pad2 and securing asealing pad2 and askin covering material3. The gel sealing pad can include a geometric shape that is an invagination or female orreceptive configuration31. The shape can include a groove or indentations, invagination orendophytic shape31. The gel seal material can include a geometric shape that is a male or protuberant or protrusion orprojection configuration32. The shape can include a male or protuberant or protrusion or projection configuration orexophytic shape32. The skin covering material can include a geometric shape that is a female orreceptive configuration31. The shape can include a groove or invagination, indentations, or endophytic shape. Theskin covering material3 can include a geometric shape that is a male orprotuberant configuration32. The shape can include an extuberance or projections orexophytic shape32. Theskin covering material3 can have one of more geometric shapes that can be male32, one of more geometric shapes that can be female31 or one of more geometric shapes that can be a combination of male32 and female31 configurations. Thesealing pad2 can include one of more geometric shapes that can be male32, one of more geometric shapes that can be female31 or one of more geometric shapes that can be a combination of male32 and female31 configurations. Thesealing pad2 can have one of more geometric or non-geometric shapes that can be minor images33 of each other. Theskin covering material3 can have one or more geometric or non-geometric shapes that can be minor images of each other. Theskin covering material3 and regions of thesealing pad2 can havefenestration34 which can include holes or areas where material is absent 34. Thesealing pad2 and the skin covering material can havefixation devices11 that can include attaching or integrating into thesealing pad2, or theskin covering material2 or theinvagination31 of the folded or moldedattachment30.
• FIG. 15 is a sagital view of theskin1 and agel sealing pad2 that is configured as a folded or molded30 configuration in which the there is a singleskin covering material3 that has abulbous component14 that can include the edge of theskin covering material3 and thebulbous component35 of theskin covering material3 is compressed bycompressive forces27 created from the surroundedsealing pad2 which can include a folded or molded30gel sealing pad2 such that theskin covering material3 is secured and constitutes a securedskin covering attachment28. Embodiments of thegel sealing pad2 and skin covering material in combination with either the folded or moldedgel sealing pad30, themale projections32,female invaginations31 or any combination with these elements can be used to form or augment a product where theskin covering material3 and thesealing pad2 can include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove or glove cover and a pants cover, a sleeve cover, a collar cover or a hat or hat cover; a garment or garment cover or a environmental protection gear or device.
• FIG. 15 is a sagital view of theskin1 and agel sealing pad2 that is configured as a folded or molded30 configuration in which the there is a singleskin covering material3 that has abulbous component14 that can include the edge of theskin covering material3 and thebulbous component35 of theskin covering material3 is compressed bycompressive forces27 created from the surroundedsealing pad2 which can include a folded or molded30gel sealing pad2 such that theskin covering material3 is secured and constitutes a securedskin covering attachment28. Embodiments of thegel sealing pad2 and skin covering material in combination with either the folded or moldedgel sealing pad30, themale projections32,female invaginations31 or any combination with these elements can be used to form or augment a product where theskin covering material3 and thesealing pad2 can include a cast cover, a wound cover, a bandage, a male condom catheter, a female condom catheter, a breathing mask that can include a surgical mask, a ventilation mask, a positive airway pressure mask that can include a CPAP or BIPAP mask, an intubation device, nose plugs, earplugs to include music ear-buds, earplugs with a conduit or channel for the transmittal of a solid, liquid or gas, eye protection or goggles to include use for industry, medicine, water usage to include scuba, and swimming, a diaper, a device to preserve the integrity or sterility of a surgical field to include inside and outside of the body or body organ or cavity, a garment cover that can include a shoe cover a glove or glove cover and a pants cover, a sleeve cover, a collar cover or a hat or hat cover; a garment or garment cover or a environmental protection gear or device.
• In some embodiments, theprojections32 of two engaging sections can be similar. Afirst protuberance32 can engage a similar,second protuberance32 on a different section of thepad2. The seal can have a geometric or non-geometric shape that insinuates itself into the skin covering material. The skin covering material can have a geometric or non-geometric shape that insinuates itself into the gel seal. The gel seal, the male projections, the female invaginations or in any combination of these elements can be at least partially composed of non-gel material and can be a combination of gelatinous and non-gelatinous materials. The gel seal, the male projections, the female invaginations or any combination of these components of the seal can be singular or redundant.
• The gel seal, the male projections, the female invaginations or any combination of these elements, can be of variable hardness and softness to include softer away from the skin than at the skin covering material, softer away from the skin covering material than at the skin, or a combination or a variation on combinations of hardness and softness between the skin and the skin covering material.
• FIG. 16 is a sagital view of theskin1, asealing pad2 andskin covering material3 which can include multiple layers and combinations ofprotuberances32 andinvaginations31, which can include one or more than oneprotuberance32 andinvagination31 or can be a combination of one or more protuberances and invaginations or a series ofprotuberances32 andinvaginations31. In one example the multilayerskin covering material3 can merge or may not merge into one solidskin covering material3 and thesealing pad2 can be assisted bycompressive force27 exerted by anexternal device23 that can include adhesive tape, afixation device11, agarment20 to include a belt, a strap or an elastic band; or amechanical device23 to include to a vice-like structure, a rubber-band like structure or a compressive bandage.
• FIG. 17 is a sagital view of an anchoring device that is used in conjunction with asealing pad2 and askin covering material3 to form a female urinary diversion system or condom catheter. In this embodiment asealing pad2 or asealing pad2 with askin covering material3 or a combination of asealing pad2 and a skin covering material can be anchored with ananchoring device35 to include a gel or a non-gel that can that uses a method to include placing a material that can include an anchoringobject35 that can be aprotuberant shape32 to include a natural shape such as the penis or a geometric shape such as a cylinder, aninvaginated shape31 to include an annular or non-annular shape to include a natural shape such as abody part8 to include a nostril, ear canal, mouth, vagina, anus or rectum or a geometric shape36 to include a funnel shape a hollow cylinder or a hollow rectangle or pyramid which can be formed from a solid or liquid, or a liquid that morph into a gel or a solid; a gel to include cyberskin, rubber latex, or silicon such that theanchor35 is formed by placing the anchoringmaterial35 into abody part8orifice37. Theorifice37 can include the nostrils, mouth, ears, anus, urethra, vagina, digestive track to include the esophagus, the respiratory track to include trachea and larynx; a surgical cavity or a natural body cavity to include an omphalocele or meningocele. The anchoringdevice35 can be used in combination with agel sealing pad2 or askin covering material3 to create an airtight or watertight seal with at least a component of the user'sskin1. Thesealing pad2 and theanchoring device35 can be used with askin covering material3 or afixation method11 that can enter theorifice8,37 or not enter theorifice8,37 or can be a combination of both enter and not enter theorifice8,37 to include thefixation device11, or standard attaching devices to include adhesives and tapes, and can be used with a livingbody part8 or a biological or living ornon-living device23 that can include a catheter ortube38, or adevice23 to include a urinary regulator, a sphincter regulator, a respiratory regulator, a heat or cold device, a pain regulator, an electrical or non electrical physiologic device that can include a physiologic indicator, monitoring device, feedback device, delivery device, permissive or inhibitory device, tissue replication device or any combination of said devices; biological tissue that can be used to treat or to monitor, feedback or deliver or permit or inhibit a biological function or assist or create biological growth or hormone or substance delivery for biological and physiological development, growth, homeostasis or regulation; or any combination of these elements anddevices23. In the preferred embodiment is ananchoring device35 can be placed into thevagina8,37, and can consist of a gel or Cyberskin tampon-like device that can simulate the shape of thevagina8,37 for comfort. Thevaginal anchor35 can be attached to a sealing pad that can be a gel that forms an airtight or watertight seal with thefemale urethra8. The seal can have askin covering material3 that can capture the urine released by theurethra8 and can be in a form to include a receptacle to include a bag or condom or tube orconduit38. Thesealing pad2 andskin covering material3 can serve as awatertight conduit38 for removal of urine away from the body without leakage of urine. This application can be used in females with an incompetent urethral sphincter, pelvic floor muscular dysfunction, muscle and nerve wasting conditions or medical diseases or entity to include multiple sclerosis, senility and amyotrohic lateral sclerosis and in situations where a female cannot use a toilet to include fighter pilots, racecar drivers, surgeons, and astronauts. The anchoringdevice35 can also be used to for sexual stimulation and pleasure and to enhance or improve sexual function or gratification in conjunction with aphysiologic device23 to include a feedback, inhibitory, permissive, delivery, and augmentation methods or devices. Another embodiment can be used as a male or femalecontraceptive device23. The anchoringdevice35 can be a protuberant shape that lies within an orifice and in some embodiments can conform to the orifice or a structure within the orifice. The anchoringdevice35 can be composed of a gel material or a non-gel material.
• An embodiment for a female urinary catheter can include a gel sealing pad surrounding the urethra. Attached to the sealing pad is a skin covering which has a bag shape that is designed to collect about 200 cc of urine with a conduit or tube at its end, which will divert the urine away from the body and the proximal urinary bag. There would be a one-way valve with the opening of the tube which would allow fluid to flow away from the body and not toward the body. The gel sealing pad will create a watertight seal around the urethra. Attached to the gel pad is an anchoring device that would be made of a semi-solid gel that conforms and fits into the vagina in a manner reminiscent of a tampon. Also attached to the sealing pad and the anchor is a web-like gel fixation device that conforms and surrounds the vaginal region. The fixation device in the preferred embodiment is attached to a garment that is in the form of a bikini or undergarment or thong or a straps that surrounds both waist and the outer buttocks.
• FIG. 18 is a sagital view and depicts aurinary collection device23 which can include are one or more than oneorifice8,37anchoring devices35 and can be placed into and include the anus and the vagina. Theorifice8,37anchoring devices35 can include one or more than oneanchoring device35 perorifice8,37 and can be used in a male or a female. In this embodiment the urinary collection device is used with a female. The orifice-anchoringdevice35 can be used alone or in combination with one or a combination of elements to include afixation device11 or agarment20 or asealing pad2, or askin covering material3, or a medication delivery system ordevice23 or can be impregnated40 with a substance or can reside within areservoir41 delivery system that can include a solid or liquid or gel or gas that can alter or augment or diminish a biological function that can include a biological acting material to include a medicine to include an antibiotic, a lubricant, a sexual stimulant or inhibitor, an anaesthetizing agent or stimulating agent, a pain altering agent, a neutralizing agent, an agent that changes the ph of a non-biological structure orbody part8, or an agent that cleanses or disinfects an non-biological structure orbody part8.
• FIG. 19 is a sagital view of a maleurinary collection device23 orcondom catheter15, in which theanchoring orifice device35 can be the anus and amale condom catheter15 can be attached to theanchoring device35. The maleurinary collection device23 has oneorifice8,37anchoring devices35 in theanus8. The orifice-anchoringdevice35 can be used alone or in combination with one or a combination of elements to include afixation device11 or agarment20 or asealing pad2, or askin covering material3, or a medication delivery system ordevice23 or can be impregnated40 with a substance or can reside within areservoir41 delivery system that can include a solid or liquid or gel or gas that can alter or augment or diminish a biological function that can include a biological acting material to include a medicine to include an antibiotic, a lubricant, a sexual stimulant or inhibitor, an anaesthetizing agent or stimulating agent, a pain altering agent, a neutralizing agent, an agent that changes the ph of a non-biological structure orbody part8, or an agent that cleanses or disinfects an non-biological structure orbody part8.
• FIG. 20 is a sagital view of acontraceptive device23 which can include one or more than oneorifice8,37anchoring devices35 and can includeorifices8,37 to include the anus and the vagina. The contraceptive device can include an orifice-anchoringdevice35 which can be used alone or in combination with one or more elements to include afixation device11 or agarment20 or asealing pad2, or askin covering material3, or a medication delivery system ordevice23 or can be impregnated40 with a substance or can reside within areservoir41 ordelivery system device23 and the substance can include a solid or liquid or gel or gas or energy source that can alter or augment or diminish a biological function that can include a biological acting material to include a medicine to include an antibiotic, a lubricant, an erection or a sexual stimulant or inhibitor, an anaesthetizing agent or stimulating agent, a pain altering agent, a neutralizing agent, an agent that changes the ph of a non-biological structure orbody part8, or an agent that cleanses or disinfects an non-biological structure orbody part8. This embodiment depicts an erectmale penis8 with askin covering material3 which is a condom which can contain a substance, areceptacle39, an impregnatedsubstance40, or areservoir41 or adevice23 that can contain a substance that can include a medication, a lubricant, a contraceptive material, a substance that alters sensation, a pleasuring substance or a biological substance that can include antibodies to a biological substance to include sperm or to an infectious agent such as Herpes virus and HIV virus and papaloma virus; or asexual pleasuring device23 to include a vibrator or electrical stimulator orfeedback device42. Thecondom3 can be intimately associated with or include afixation device11, and asealing pad2, and agarment20. The contraceptive device can be anchored using anorifice8,37anchoring device35 which can include an anal8,37anchor35. The anal8,37anchor35 can be used alone or in combination with one or more elements to include afixation device11 or agarment20 or asealing pad2, or askin covering material3, or a medication delivery system ordevice23 or can be impregnated40 with a coating substance or can reside within areservoir41 delivery system that can include a solid or liquid or gel or gas that can alter or augment or diminish a biological function that can include a biological acting material to include a medicine to include an antibiotic, a lubricant, a sexual stimulant or inhibitor, an anaesthetizing agent or stimulating agent, a pain altering agent, a neutralizing agent, an agent that changes the ph of a non-biological structure orbody part8, or an agent that cleanses or disinfects an non-biological structure orbody part8. The anal8anchor35 can contain a coated substance, areceptacle39, an impregnatedsubstance40, or areservoir41 or adevice23 that can contain a substance that can include a medication, a lubricant, a contraceptive material, a substance that alters sensation, a pleasuring substance or a biological substance that can include antibodies to a biological substance to include sperm or to an infectious agent such as Herpes virus and HIV virus and papaloma virus; or asexual pleasuring device23 to include a vibrator or electrical stimulator or afeedback device42. In the female thevagina8 or theanus8 or thelocal skin1 andskin covering material3 between thevagina8 andanus8 can contain a medication delivery system ordevice23 or can be impregnated40 with a coating substance or can reside within areservoir41 delivery system that can include a solid or liquid or gel or gas that can alter or augment or diminish a biological function that can include a biological acting material to include a medicine to include an antibiotic, a lubricant, a sexual stimulant or inhibitor, an anaesthetizing agent or stimulating agent, a pain altering agent, a neutralizing agent, an agent that changes the ph of a non-biological structure orbody part8, or an agent that cleanses or disinfects an non-biological structure orbody part8. The anal8anchor35 can contain a coated substance, areceptacle39, an impregnatedsubstance40, or areservoir41 or adevice23 that can contain a substance that can include a medication, a lubricant, a contraceptive material, a substance that alters sensation, a pleasuring substance or a biological substance that can include antibodies to a biological substance to include sperm or to an infectious agent such as Herpes virus and HIV virus and papaloma virus; or asexual pleasuring device23 to include a vibrator or electrical stimulator or afeedback device42.
• FIG. 21 A is a sagital view of anostomy8sealing pad2 andskin covering material3. In this embodiment theanchoring device35 can be placed within askin1tunnel43 or crease in the body44. A crease44 in thebody8 can include the crease of the buttocks or adipose folds of the belly in an obese individual or a surgically constructed crease or tunnel can be created. Atunnel43 in the body can include a surgically constricted crease, an internal cavity, anatural body part8 tunnel such as a muscle and bone interface or an internally or externally constructedskin1tunnel43 which can be constricted near and ostomy site. One embodiment can include the use of thesealing pad2 and theskin covering material3, as anostomy seal2 andbag3 and askin1 surgically tunnel to house the anchoring device which can be composed of a material to include a biological compatible silicon, gel, metal or other solid of gel. In one embodiment at least one component of theanchoring device35 can reside between the layers of theskin1 or within theskin1 or deep to theskin1 or in abody part8 to include a muscle. A second component of theanchoring device35 can reside between the layers of theskin1 or within theskin1 or deep to theskin1 or in abody part8 to include a muscle or external to theskin1 orbody part8. In one embodiment the one embodiment the seal can be a gel seal, and thatgel sealing pad2 can include asealing pad2 that resides between the two anchoringcomponents35 or one or more of the anchoring components can reside within thesealing pad2, the skin covering3 or afixation device11 or agarment20. One or more than one of the anchoringcomponents35 in the preferred embodiment can be magnetic and can be ferromagnetic or a combination ferromagnetic magnetic. The anchoring device can anchor the gel seal with the use of a method to include electromagnetic forces or energy. Other methods can be used in alone or in combination with electromagnetic energy for attaching thetunnel43 or crease44anchoring device35 and can include thefixation device11 as well as standard methods of attaching and anchoring to include adhesives, tackifying agents, hooks, Velcro, Ziploc, straps, belts and elastics. In the preferred embodiment the either thegel sealing pad2 or theskin covering material3 or both can form anostomy bag3 in which theostomy8 has a tunnel that contains asilicone ring35 that is magnetized. Thegel sealing pad2 can also be magnetized or can be ferromagnetic and create a tight bond between theanchor35 and the gel seal. Thegel sealing pad2 creates an airtight and watertight seal with the skin and the skin covering material, which is anostomy bag3 allows for the capture and the flow of fecal material away from the body, This method avoids adhesives, which serve to break down the skin over time and lead to ulcers and infections of the skin. Either thesealing pad2 or the skin coveringostomy bag3 or both can be removable and replaceable. Asealing pad2 andskin covering material3 andfixation device11 and theanchor35 or a combination of these elements can all be removable and replaceable. Another embodiment not depicted is an appliance that is subcutaneous that can include an appliance that has projections that project from the appliance that can include in the preferred embodiment projections that exit from the skin and contain a method for attachment to an external appliance or ring that can include a ziplock-like device or Velcro like device or magnet or any male and female connection that can include a screw or pin or hook or locking mechanism or any combination of these attachments. Between the skin appliance and the external appliance there is asealing pad2 or gasket that can include allow an ostomy to remain airtight and watertight. In the preferred embodiment the external appliance can have a skin covering material that can capture the body's8 discarded contents. Other embodiments can include use with a condom, or a urinary or condom catheter, the anus and fecal material, enzyme and organ secretions or excretions or discards that can include biliary and pancreatic bowel and intestinal and gastric contents.
• FIG. 21B is a sagital depiction of a closure method and device that can include projections and invaginations that in the preferred embodiment can include magnetic pins, hooks, Velcro, Zip-locks, buttons, andother fastening115 devices that secure theskin tunnel43 appliance to the external appliance or sealingpad2 and skin covering3 using a method that provides adequate resistance to separation such that thesealing pad2 and skin covering2 andsealing pad2 are securely attached to theskin tunnel43 appliance but can also be removed for disposal contents and also will not tear the skin or tear out theskin tunnel43 appliance if there is a sudden force or tug placed on thesealing pad2 andskin covering material3.
• FIG. 22 is a sagital view of asealing pad2 with overlapping ends and depicts how thesealing pad2 orskin covering material3 or thefixation device11 or the combination of thesealing pad2 and theskin covering material3 and thefixation device11 can be joined together using closure methods anddevices7 to include Zip locks, Velcro, pins or pegs, thread, ties, hooks, zippers, adhesives, buttons, elastic materials or any electromagnetic attachment to include electromagnetic forces and energy to include magnets or mechanical or electromechanically devices such as retractable grappling, hooks or interlockingdevices23.Closure methods7 can be used alone or in combination. Thesealing pad2 or the skin covering3 or thefixation device11 can be closed overlapping or not overlapping and placing the ends adjacent or in opposition to each other. If a gel is used for thesealing pad2 then the gel can be variable in its softness andhardness94 and can include being firmer and harder94 near theclosure device7 than away from theclosure device7.
• FIG. 23 is a sagital view of adevice23, which uses ananchoring device35 that is formed by anchoring theanchoring device35 to abody part8 which can include a tooth or the teeth. In the preferred embodiment theanchoring device35 can include using one or more mouth-guards49 that can include at least a portion of the gums or mucosa, a tooth, the teeth or a groups of teeth or the upper or lower rows of teeth or any combination of these teeth. The anchoring device can be used with asealing pad2 orskin covering material3 or thefixation device11 or the combination of asealing pad2 andskin covering material3 andfixation device11 to create adevice23 to include a breathing mask to include a ventilation unit, a CPAP or BIPAP or positive ventilation mask, or anesthesia mask or other means to ventilate the user which can include human and non-human creatures. The skincovering material mask3 can be attached directly to theanchoring device35 or can have a bridgingstructure47 between the anchoringdevice35 and the skin coveringmaterial mask3. Theskin covering material3 can includefenestrations34 conduits ortubes38 for the transfer of solids or liquids or gases or gels for uses to include ventilation or irrigation or aspiration. Thesealing pad2 and theskin covering material3 can include coveringbody parts8 andorifices8,37 to include the mouth, ear, nose and nostrils, ear canals, a surgical or natural body cavity, the vaginal, urethra, anus and rectum and ostomy which can include an intestinal or bowel diversion or ureteral or urethral diversion or tracheostomy or diversion of anotherbody part8.
• FIG. 24 is a sagital view of adevice23, which uses ananchoring device35 that is formed by anchoring theanchoring device35 by a means to include anchoring theanchoring device35 using at least one brace ortooth appliance48 that can include anchoringdevice23 that anchors a the tooth orteeth46 by surrounding at least a portion of thetooth46 with a solid or gel material that can include metal braces, plastic braces, latex, non-latex materials, a rubberdam and rubberdam-like device, rubber and rubber-like materials that can include at least a portion of abody part8 to include a tooth, the teeth or a groups ofteeth46 or the upper or lower rows of teeth or any combination of theseteeth46 orgums8. The anchoring device can be used with asealing pad2 orskin covering material3 or thefixation device11 or the combination of asealing pad2 andskin covering material3 andfixation device11 to create adevice23 to include a breathing mask to include a ventilation unit, a CPAP or BIPAP or positive ventilation mask, or anesthesia mask or other means to ventilate the user which can include human and non-human creatures. The skincovering material mask3 can be attached directly to theanchoring device35 or can have a bridgingstructure47 between the anchoringdevice35 and the skin coveringmaterial mask3. Theskin covering material3 can includefenestrations34 conduits ortubes38 for the transfer of solids or liquids or gases or gels for uses to include ventilation or irrigation or aspiration. Thesealing pad2 and theskin covering material3 can include coveringbody parts8 andorifices8,37 to include the mouth, ear, nose and nostrils, ear canals, a surgical or natural body cavity, the vaginal, urethra, anus and rectum and ostomy.
• FIG. 25 is a sagital view of adevice23, which uses ananchoring device35 that is formed by anchoring theanchoring device35 by a means to include anchoring theanchoring device35 using at least one brace ortooth appliance48 that can include anchoringdevice23 that anchors a the tooth orteeth46 by surrounding at least a portion of thetooth46 with a solid or gel material that can include metal braces, plastic braces, latex, non-latex materials, a rubberdam and rubberdam-like device, rubber and rubber-like materials that can include at least a portion of abody part8 to include a tooth, the teeth or a groups ofteeth46 or the upper or lower rows of teeth or any combination of theseteeth46 or gums Band the anchoring device can include using one or more mouth-guards that can include at least a portion of the gums or mucosa, a tooth, the teeth or a groups of teeth or the upper or lower rows of teeth or any combination of these teeth.
• The anchoring device can be used with asealing pad2 orskin covering material3 or thefixation device11 or the combination of asealing pad2 andskin covering material3 andfixation device11. In the preferred embodiment theanchoring device35 can include using at least one, mouth-guard49, or bite-block or brace ortooth appliance48, that can include a device that anchors the tooth orteeth46 by surrounding at least a portion of thetooth46 with a solid or gel material that can include metal braces, plastic braces, latex, non-latex materials, a rubberdam and rubberdam-like device, rubber and rubber-like materials that can include at least a portion of a tooth, the teeth or a groups of teeth or the upper or lower rows of teeth or any combination of theseteeth46 that can be used with atongue8appliance50 that can restrict or alter the tongue's8 movements to include preventing thetongue8 from sliding backwards and obstructing the respiratory airway; or an epiglottic8appliance50 that can restrict or alter the epiglottis movements to include preventing theepiglottis8 from sliding down or backwards and obstructing the respiratory airway; or a soft palate ormucosal8appliance50 that can restrict or alter theepiglottis8 movements to respiratory airway or a combination of theabove appliances50. This can be used for sleep apnea or other conditions that are dependent on the position of the tongue, lips, teeth, or other components of the human mouth.
• FIG. 26 is a frontal view of anostomy fixation device11 that can be used with agarment20 or a material to include clothing or agarment20 or a belt that can be composed of a material to include cloth, fabric, natural or synthetic-man-made materials to include nylon, rayon, and polyester-like materials, plastics, plant based materials, metals and metal mesh material. In the preferred embodiment afixation device11 can include gel and is intimately associated with agarment20 and thefixation device11 can be separate or integrated into thegarment20. Thefixation device11 and thegarment20 can be associated with or be integrated into asealing pad2, askin covering material3, and anchoringdevice35 and in the preferred embodiment thegarment20 andfixation device20 and utilize to assist in fixing anostomy sealing pad2 andskin covering material3 in the form of an ostomy bag in proper location and other uses can include use with a urinary diversion catheter, a contraceptive device, a breathing mask, a device to alter sensations to include pain and pleasure and temperature and touch and pressure.
• FIG. 27 is a breathing mask or ventilation orintubation device23 which can use agel sealing pad2 or asealing pad2 with askin covering material3 in conjunction with a liquid solution or a solid material or a gas or a mixture of these substances as an exchange material that can facilitate the organism gas exchange of substances such as oxygen or carbon dioxide. Themask3 can facilitate the osmotic exchange of other blood containing substances such as urea, glucose, and electrolytes and minerals and can form as a form of dialysis. The introduction of substances such as medications can be facilitated by the breathing mask to include antibiotics, anti-fungal and anti-viral drugs, surfactant materials and other lung performance facilitating medications. Some of the substances that can be used to exchange vital gases for organisms can include chemical compounds which can carry and release oxygen perfluorocarbons (PFCs of which a specific PFC used is perfluorodecalin; hemoglobin derived from humans, animals, or artificially via recombinant technology, Hemoglobin-based oxygen carriers, to include lecithin surfactants, Oxygen, Oxycyte PHER-O2, and Perftoran.
• In the preferred embodiment agel sealing pad2 with askin covering material3 that serves as a ventilation tube can be used to intubate an organism. Thesealing pad2 forms an airtight seal with the digestive track to include the esophagus and GE junction and stomach to prevent liquids from entering the stomach this seal should be airtight and watertight. Coincidentally a second seal is formed with the respiratory track to include the larynx, trachea or bronchi or their branches. Once a seal is formed with at least one of the two passages, the digestive passage or the respiratory passage or with both passages, the liquid ventilation can commence. In the preferred embodiment theintubation device23 can be branched with one or more branches with one branch extending into the esophagus anddigestive tract51 and the other branch appendage extending into thenasal pharynx52 and another branch extending into the portion of the respiratory track that includes the trachea andbronchi53. Agel sealing pad2 can contain areservoir41 that is filled with a solid or liquid or a gas and can expand to create an airtight or watertight seal to include one or more than onebody parts8 andorifices37 to include thedigestive tract51, thenasal pharynx52, the respiratory track trachea andbronchi53. Indicators and measuringdevices54 andfeedback devices42 can be used to control the degree of expansion of thegel sealing pad2 and thereservoir41 to include regulation of reflux, water tightness and air tightness, substance exchange to include solids and liquids and gels and gases. In another embodiment the intubation device can contain indicator and measuringdevices54 on the surface or internal to thesealing pad2 that can feedback to the individual who is ventilating or intubating the individual who is intubated with measurements to include the pressure of the gel on the mucosa or skin or cavity and feedback can include altering the reservoir inflation or deflation. In another embodimentadditional sensors54 can include temperature probes and softness andhardness94probes54 which can be used with one ormore sensors54 and in one embodiment a method for softening or hardening the gel can include areservoir41 that can be expanded or a heating or a coolingfeedback42 unit that can be placed into the gel sealing pad or near thegel sealing pad2 or into theskin covering material3 or near theskin covering material3 to alter the physical characteristics of thegel sealing pad2 to make thegel sealing pad2 and its seal more effective or to reduce the stress of the intubation device on themucosa1 or cavity skin and lining1 depending on thesensor measurements54.
• FIG. 28 is a frontal view that depicts the isolation of abody part8 on the external portion of the body or the internal portion of the body to include a cavity or within a cavity or within thebody8 or within a hollow viscous organ can include the isolation of a body part to include an ovary can be created by using an annular sealing pad that can be a gel or a non-gel material and a skin covering material to include the isolation of a body part that can include the isolation of a cancerous ovary from the remainder of the pelvic cavity to include the prevention of the spillage of ovarian cancer cells into the pelvic cavity or to isolate theovary55 for the application of energy or a substance to include medication, chemotherapy or other gases or liquids or gels or solids or radiation or ultraviolet or infrared or visible light or other electromagnetic energy or kinetic energy that are to be delivered to the body part to include the ovary and restricted from other body parts to include the pelvic cavity. Thesealing pad2 or the skin covering3 can have one ormultiple conduits16 that can provide for the instillation and removal or medication or therapeutic substances into the treatment region while protecting the remainder of the body from the effects or side-effects of the energy, medication or therapeutic substances including the combination of energy and substances to activate or equilibrate or deactivate their effectiveness. The sealing pad and the skin covering material can include one or more or a combination of tube orconduits16,reservoirs41,fenestrations34, impregnatedmaterials40indicators54,feedback devices42, anchoringdevices35,receptacles39,devices23 that createcompression devices27,fixation devices11, orflanges4 or treatment devices.
• FIG. 29 is a frontal view that can consist sealingpad2 andskin covering material3 that can be utilized to include a cast or bandage or wound56cover3 that can contain areservoir41 or one ormore conduits16 for delivery or removal of substances containing a solid or liquid or gel or gas that can include a therapeutic, pleasurable, moisturizing, humidifying or drying, heating or cooling, anti-itching substance or medication. The use of the substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying agent or filter, altering sensation to include relieving pain; dehumidifying or humidifying, heating or cooling, or the delivery of a gas or gel or liquid, or solid for therapeutic purposes or to alter a biological function.
• FIG. 30 is a frontal view that depicts areservoir41 that can be a compressive device and can contain a solid, liquid or gel or gas or a combination of these elements that can adjust theairtight sealing pad2 in situations that require greater forces this can include a situation where there is a laceration57 of ablood vessel60 that includes uncontrolled bleed that fills thesealing pad2 and skin covering3 andinternal chamber61 with blood. In that situation the goal is to attain a pressure in theinternal chamber61 that is equal to, or greater than or less than the arterial inflow pressure which in one embodiment can be theupstream sealing pad2, which is acting as a tourniquet. In this situation the object is to allow some arterial inflow to keep the tissue alive but restrict the bleeding. In the preferred embodiment this can be measured with anindicator54 to include a measuring device or monitor to include an oxygen monitors to access tissue viability and vascular60 flow with a monitor to include a blood pressure monitor or anultrasound99 Doppler monitor58 to access the vascular waveform which can be connected to theexternal environment62 though tubes andconduits16 that maintain the airtight and watertight seal and can communicate with anexternal device59 either through wireless or non-wireless methods.
• In another embodiment thesealing pad2 and theskin covering material3 can serve as an internal61 isolation chamber, which can serve as a therapeutic chamber which can be used to treat a laceration57 with uncontrolled bleeding. The sealing pad can contain a reservoir orbladder41 or have a device that constricts or contracts thegel sealing pad2 between thesealing pad2 and theskin1, within thesealing pad2 or external to thesealing pad2. In the preferred embodiment the constrictingsealing pad41 is placed at the location of the wound where there isarterial inflow60. Thecompressive sealing pad2 can serve as a tourniquet that can allowblood flow60 into the wound to increase, decrease, remain the same, vary the flow or any combination of these flow speeds or elements. The wound can be isolated to achieve keeping the wound clean, tamponating the wound, stopping the bleeding and treating the wound that can include medicines to include antibiotics, coagulants and anticoagulants, QuikClot and Chitosan, an extract from shrimp shells and blood products to include platelets. The pressure within the internal61 isolation chamber can also be regulated to increase, decrease, remain the same, equilibrate or vary or be a combination of these elements relative to the seals, tourniquet, tamponating agents, atmospheric pressures, arterial or venous or body pressure or a combination of these elements can be used to regulate the optimal equilibrium between adequate blood flow and oxygenation to the tissue and at and distal to the laceration. The oxygen and gas content in the internal61 isolation chamber can be controlled and regulated to also include assist in physiologic homeostasis and cell survival and clotting and other primary biological functions for survival of the organism and the components of the organism.
• In the preferred embodiment this can include the combination of regulating the inflowgel sealing pad2 controlling and regulating arterial inflow in the lacerated artery through regulated pressure on the artery, in combination with regulated oxygenation within the isolation chamber, in combination with varied pressure within the chamber, in combination with medications to induce clotting, in combination with wound isolation and medications to reduce infections, may provide for greater cell and tissue andlimb8 andorganism8 survival. In another embodiment one or more chambers can be utilized which can include treating the tissue distal to the laceration with a second isolation chamber with characteristics dissimilar from the first chamber. Additional treatments can include electromagnetic energy to include UV energy, Infrared energy, radiation, visual energy fields, chemical energy, kinetic, and vibration energy and these treatments can be used alone or in combination to activate, deactivate or equilibrate the treatment.Additional devices23 that can be used in conjunction with these embodiments can include indicators or measuringdevices54,feedback devices42,fixation devices11 or anchoringdevices35.
• One or more than one additional skin covering materials66 or chambers66 can reside lie within the chamber or be integrated into theskin covering material3 orseal2 or can lie external62 to the primaryskin covering material3 or a combination of these elements, which can include a rigid frame, a flexible chamber that can include an air-cast to supplement, an external pressure orcompression27 chamber that can facilitate the function of theprimary sealing pad2 andskin covering material3. One method of treatment can include a method where the vascular60 arterial blood vessels bleeding can be controlled when theinner chamber61 is equivalent to or greater than systolic pressure. The systolic pressure in the lacerated artery57 can be regulated and decreased to a manageable level that provides some arterial inflow and oxygenation to the tissue adjacent to or distal to the lacerated vessel. If lower arterial inflow pressure simulating diastolic inflow to the distal tissue can be achieved and a element of venous return can be maintained, then it is more probable than not that a delicate equilibrium can be achieved and maintain to allow survival of the body part, specifically a limb, and its function. The inflow-sealing pad2 serves as an inflow tourniquet. The arterial waveform can be measured by vascularmeasuring techniques device54 to includeDoppler ultrasound99. The pressure of the inflow-sealing pad will be adjusted in response to multiple feedbacks including the inflow distal to the inflow-sealing pad, which can include a reduction peak systolic pressure and reduction in overall inflow volume. Other inflow feedbacks42 will include down-flow measurement to includeDoppler ultrasound99 of the arteries and veins, tissue pressure, oxygenation which can be measured by indicators and measuring devices to include pulse oximeters, and oxygen and carbon dioxide and lactic acid and sugar monitors to include glucose. Once inflow is regulated then the blood that is leaking from the vascular lacerations will fill the internal environment of the isolation chamber. The rigidity and the seal of the internal skin coveringisolation chamber61 can be assisted by one or more than one additional chamber or external skin covering3 to include a rigid skin covering material, an inflatable compression chamber that can simulate a an inflatable air cast that is used for transport or a pressure body suit that is used for stabilization of transported individuals and the second skin covering material can in the preferred embodiment reside external59 and adjacent to the internalskin covering material3 and the internal61 isolation chamber. Blood will fill theinternal chamber61. This blood will be used to form a rigid clot that surround the laceration and can seal the laceration by utilizing clotting materials that can harden and clot exsanguinating blood. Methods of clotting can include solids, liquids, gels or gases to include substances and energy forms to include medications, medications that can be activated and deactivated and equilibrated using another substance to include solids, liquids, gels or gases and energy forms to include substances and energy forms to include medications, medications that can be activated and deactivated and equilibrated and energy forms to include electromagnetic energy, chemical reaction, kinetic energy to include Brownian-energy, heating and cooling and vibration energy forms. These can be delivered through conduits ortubes16 orreservoirs41 ordevices23 that can deliver substances and energy from theinternal environment61 or form theexternal environment62 or through thebody8.
• One of the objects of this therapy will include form a natural clot graft for the damagedvessel60 during the critical period of transportation to a facility and to care that can more permanently repair the injuredbody part8. In addition to forming the blood graft or clot, the oxygenation of theinternal isolation chamber61 chamber can be regulated to create a mini-hyperbaric chamber or mini-hyper-oxygenation chamber to hyper-oxygenate the tissue that is subject to the diminished perfusion. In addition, toxic by-products of ischemia can be removed through osmotic means to include a second adjacent isolation chamber (not depicted) that can have aninternal environment61 that can address the needs of the distal aspect of an ischemic body part. In the preferred embodiment this can include treating a laceration of the femoral artery in the leg and placing the first andprimary isolation chamber61 around the leg and having asecond isolation chamber61 around the foot and ankle region and treating second isolation chamber that contains this ischemic portion of the limb or that same leg in a manner that differs from the first isolation chamber, One example can include focusing treatment of the first isolation chamber to control bleeding and preserving oxygenation of the local tissue and the attempting to supply some distal blood flow oxygenation while the second isolation chamber may focus on super-oxygenation the distal limb which in this case include the ankle and foot and this can be done by means to include a form of osmotic limb dialysis that bathes the distal extremity in materials to include solids and liquids and gels and gases that can include remove toxic biological materials to include lactic acid and carbon dioxide and deliver advantageous biological materials that can include oxygen, proper ph, and glucose. This process would be monitored by measuring andindicator devices54 andfeedback devices42.
• FIG. 31 is a frontal view of a condom which is askin covering3. The condom63 can include askin covering material3 or askin covering material3 and asealing pad2 or a combination of these elements. Thesealing pad2 and skin covering3 can have anindicator54 that can measure or assess elements to include a pH, protein, sperm, or fructose or other sugars, which can be displayed using a method to include analog or a digital displays or halochromic materials which can change their color as a result of changing acidity to include a color indicator to include a pH indicator dye to include the detection of semen or vaginal fluid. For the male the pH of semen is 7.2 to 7.8 and for the female the pH of vaginal fluid is 3.8 to 4.5 also semen contains specialize proteins which can include a method to include anti-semen antibodies or using biuret solution to indicate the presence of protein which can be measure using a microchip or a color indicator which can give a signal to include an analog or digital signal, which can be used with a female or male contraceptive device to indicate mingling or leakage or loss of integrity between the penile64 or and the vaginal69 side of the seal and skin covering material. In one embodiment to include if a male condom is used then an indicator can be place on the outside of the condom. If sperm and seminal or penile64 fluid leaks to the outside then the ph of the vaginal69 fluid will change because of the difference between the vaginal and seminal pH and this change can be measured with a color indicator, or an indicator containing anti-sperm antibodies which when in the presence of sperm reacts and creates a reaction that can be detected by an analog or digital method or a sugar indicator which when fructose is present (fructose is found in seminal fluid) will be detected and will provide an analog or digital signal. In either the male or female condom theindicator54 can be placed on theinner chamber side61 or theexternal chamber side62. If theindicator54 reveals a breech in the skin covering3 orsealing pad2 then afeedback device42 can release a substance which can include the condom63 including areservoir41 that can mechanically release a substance to include a solid or liquid or gel or gas to neutralize or treat the effects of the breech which as related to this embodiment of contraception include the release of a contraceptive medication to include an anti-spermacide, a gas that kills the sperm, a substance that creates an unfavorable environment for fertilization to include a substance that changes the ph of the vaginal69 fluid. In another embodiment not depicted a femalecontraceptive device23 or condom63 can be created using similar elements. In either the male or female contraceptive condom63 theindicators54 or neutralizing substances can reside on the internal chamber orenvironment61 or external chamber orenvironment62 relative to theisolated body part8. In another embodiment the indicator can be integral to or impregnated40 into the skin covering3 orsealing pad2.
• FIG. 32 is a frontal view of an isolation chamber which include a sealing pad2 and skin covering3 or fixation device11 or an anchoring device35 and flanges4 or one or more additional chamber or device23 can be utilized within the internal chamber or environment61 or external environment62 that can facilitate the effects of the isolation chamber can be added or any combination of these elements, which can become a contained and localized isolation chamber or internal environment61 management chamber to include managing a body part8 or the entire body8 to include using indicator54 and feedback mechanisms42 for managing to include the pH, gas content, the aerobic or anaerobic nature of the isolated environment, elemental content, substance or medication content, electromagnetic content to include radiation or visible or non-visible light spectra to include UV and infrared light, to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, infectious elements, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications. In the preferred embodiment thesealing pad2 and theskin covering material3 can serve as an isolation chamber which can serve as a mini therapeutic or hyperbaric or hyper-oxygen chamber in which the management of the pressure or gas levels can utilize areservoir41 in thesealing pad2 or skin covering3 or channels orconduits16 or theinternal chamber61 for the ingress and egress of gas to include oxygen and other gases and to manage the pressure in the chamber to include a pressure that is less than, equal to or greater than atmospheric pressure. Uses of this isolation chamber can include the treatment of wounds, infections to include aerobic infections which can be denied oxygen, anaerobic infections which can be killed with oxygen or in an oxygen only environment, antibiotic resistant infections to include MRSA infections in which the antibiotic level, or a toxin or a gas mixture or a combination of these elements can be used to treat the infection at a localized site with specific therapeutic methods while isolation other regions of the body from these same therapeutic levels. In another embodiment thesealing pad2 and theskin covering material3 can serve as aninternal environment61 isolation chamber which can serve as a therapeutic chamber to deliver radiation sensitizing materials that can include 5-chlorodeoxycytidine (5-CldC) or 5-halo-2′-halo-2′-deoxy-cytidine or -uridine derivatives, Tetrahydrouridane (H.sub.4 U) and 2′-deoxytetrahydrouridine (dH.sub.4 U) co-administered with the deoxycytidine derivative to inhibit deamination of the deoxycytidine derivatives, agents to reduce the amount of competing metabolites to favor CldC, such as 5-fluorodeoxyuridine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU), chlorozotocin, 1,3-biscyclohexyl-1-nitrosourea (BCyNU), and 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU). CCNU, BCyNU, and BCNU; such that when radiation is administered the area being isolated can achieve an added effect from the radiation. In another embodiment thesealing pad2 and theskin covering material3 can serve as aninternal environment61 isolation chamber which can serve as a therapeutic chamber to deliver radiation resistant materials to include antioxidant compounds such that when radiation is administered the area being isolated can achieve a diminished effect from the radiation. In another embodiment thesealing pad2 and theskin covering material3 and at least oneindicator54 andfeedback device42 can serve as anisolation chamber61 which can serve as a therapeutic chamber in which at least one indicator can be used for the adjustment, management and regulation and assessment and treatment which can be used to treat a ailment to include cancer, auto-immune diseases, degenerative diseases, aging, and other biological condition and in which the feedback mechanism can be used to locally deliver a substance to include a solid, a liquid, a gel or a gas to include a substance that can include a medication that can include chemotherapeautic agents to include steroids to include prednisone and dexamedrol; and carbo and cis-platinum adriamycin, avastin, methotrexate and taxol and medications to alter biological functions to include sensation to include the use of lidocaine or marcaine.Other devices23 can be used with these elements to includefixation devices11 and anchoringdevices35.
• FIG. 33 is a sagital view of a female urinary retention anddiversion device23 that in the preferred embodiment there can be a combination of asealing pad2, askin covering material3, ananchoring device35 that can include ananal anchor68 or a vaginal69 anchor, afixation device11, anindicator54 or afeedback device42 or a stimulatingdevice70 or any combination of these elements can be used with a condom catheter or micurition device and can be used to include train or affect or improve urinary urethral65 andpelvic floor muscle67 function to include indicators which are sensing54 andfeedback54 and stimulating70 and can include neuro-musculature stimulating70 electrodes and sensing42 units for micturition and urination control and can also include biological andbody part8 functions to include sexual, erectile, ejaculation and micturition and orgasm function, penile64, prostate, bladder, vaginal muscular contraction and relaxation, neuro-musculature control, fecal and anal and rectal, the pelvic floor muscle and pelvic floor fascial control. In the preferred embodiment an indicator can be present to provide neuro-muscular strength and tone and signal that can be connected or can be used separate from a neuro-musculature stimulating unit that can help train the neuro-muscular system for urination or can automatically trigger a neuro-muscular stimulus that can provide neuro-muscular control to the dysfunctional body function to include the neuro-musculature units in an effort to improve and control urinary function. Theindicator42 andsensor42 and thefeedback54 and stimulatingunit70 can be in thesealing pad2, askin covering3, ananchoring device35, afixation device11, afeedback device54 or asensing device42 or any combination of these elements and located in thevagina69,rectum68 andanus68, the tissue around thepenis64 orvagina69 oranus68, prostate, pelvic floor. In one embodiment there can be wires implanted in themusculature67 that assist urination which can measure leakage of urine and can be interfaced with the condom catheter or training unit throughelectrodes70 or amedication delivery device23 or a warming or coolingdevice23. Other applications of this form of stimulation can include treating or facilitating and enhancing sexual, ejaculation, erectile function, orgasm, pleasure, arousal and prolongation of these and related biological functions. In another embodiment the feedback mechanism can contain at least one input and one output signal or any combination of inputs or outputs that can include electromagnetic, kinetic, and motion and othersensory signals42 and feedback signals54.
• FIG. 34 is a sagital view of asealing pad2 and askin covering material3 that containsindicators54 andfeedback devices42 that can used being used as a breathing mask to include a CPAP mask, a BIPAP mask, an anesthesia mask a scuba or snorkeling device. In one embodiment that can include asealing pad2 and a skin wound andcancer covering material3 thesealing pad2 and theskin covering material3 can include anindicator device54 that can be utilized to provide feedback to afeedback device42 to the regulate thesealing pad2, theskin covering material3, theinternal environment61 between thesealing pad2 and the skincovering material complex3 and the skin, the external environment outside62 of thesealing pad2 and the skincovering material complex3, or a combination of these regions and elements. One or more than oneindicator54 can be used to regulate and adjust and measure parameters and can include zero, one or more than onefeedback device42 to provide feedback through a feedback device to include the pH, gas content, the aerobic or anaerobic nature of the isolated environment, elemental content, substance or medication content, electromagnetic content to include radiation or visible or non-visible light spectra to include UV and infrared light, to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications, and the biologic and physiologic parameters of the tissue or body part being isolated. The material or energy being delivered or removed from the isolation chamber can be located between thesealing pad2 and skin covering complex3 and theskin3 orbody part8, or can be a part of thesealing pad2 andskin covering material3, or can be external62 to thesealing pad2 andskin covering material3 or can be a combination of these elements. The delivery or removal system for material or energy being delivered to or being removed from theisolation chamber61 and theskin1, body part ororganism8, can be located between thesealing pad2 and skin covering complex3 and theskin1, or can be a part of thesealing pad2 and skin covering complex3, or can be external62 to thesealing pad2 and skin covering complex3 or can be a combination of these elements. The matter or energy being delivered or removed can be delivered or removed by methods to include channels andtubes8, wires, osmosis, chemical reaction, kinetic energy or electromagnetic energy. The indicator54 and the adjustment can provide feedback can include physiology of the body that can include pulse, blood pressure, temperature, glucose levels, biomechanical measurements, carbon dioxide and oxygen and gas levels, oxy and deoxyhemoglobin levels and other basic metabolic functions and measurements to include wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, muscular function, substance levels to include drugs and medications and non-physiologic measurements to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications a combination of physiologic and non-physiologic measurements.
• Thesealing pad2 and theskin covering material3 and theindicator54 can be connected to at least onedevice54 that can adjust, regulate, manage, and assess the physiology or biology of the isolated tissue or body part ororganism8 and adjust the device to optimize, alter or coordinate the needs or biologic function or physiology of the isolated tissue or body part ororganism8 and contain zero, one or more than onefeedback device42. In one embodiment the complex of thesealing pad2 and theskin covering material3 and at least oneindicator54 orfeedback device42 or any combination ofindicators54feedback devices42 can measure and be used to include manage, adjust, regulate and assess the oxygen and carbon dioxide and pressure in a breathing apparatus that can include a ventilator,CPAP device2,3, or anesthesia device that can measure the physiology of the organism, with parameters to include oxygen and carbon dioxide levels, anesthetic levels and the breakdown products of the anesthesia, the pressure of the gas being inhaled and exhaled and delivered and removed, the sound of the snoring of the organism and the biological and physiological parameters of the organism including arterial oxygen saturation levels. In another embodiment the complex of thesealing pad2 and theskin covering material3 andindicator54 andfeedback mechanism42 or any combination of these elements can measure and be used to include manage and feedback, adjust, regulate or assess the sound of the snoring which can be used manage, adjust, regulate and assess the physiologic or biologic parameters of anexternal device72 to include a ventilator to serve anorganism8 who is snoring and adjust the gas levels and the pressure to minimize snoring while maintaining proper homeostasis and health of theorganism8.
• FIG. 35 is a frontal view of anindicator54 or measuringdevice54 and afeedback device42 that in the preferred embodiment include use with asealing pad2 and theskin covering material3 and at least oneindicator54 that can assess and give feedback and can use zero, one or more than onefeedback device42 to give information on physiology and biology, or mechanical orenvironmental stimuli73 orinformation73, and said information can be transmitted to afeedback device42 or an additional device that can include anexternal device72 device that can alter the physiology or biology or mechanical orenvironmental stimulus73 orother information73 to include snoring or the sound of theventilator72 ortubes16 near thesnoring individual8, which can be measured and the information transmitted to adevice72 to include an acoustic receiving23 or alteringdevice23 that can include noise cancellation computers, equalizers, electrical devices,earbuds76 orearphones76 which from a distance or be located on or near or at oneorganism8 that can include cancel mute, transmute or alter the sound of thesnoring73, for at least onorganism8. In another embodiment theindicator34 and the feedback device can be used with or without thesealing pad2 and with or without thesealing pad2 orskin covering material3 and can assess and give feedback on physiology and biology, or mechanical orenvironmental stimulus73 orinformation73, and saidinformation73 can be transmitted to adevice23 that can alter the physiology or biology or mechanical or environmental stimulus or other information to include snoring or the sound of theventilator72 ortubes16 near thesnoring individual8, which can be measured and the information transmitted to adevice72 to include an acoustic receiving23 or alteringdevice23 that can include noise cancellation computers, electrical devices,earbuds76 orearphones76 which from a distance or be located on or near or at oneorganism8 can cancel mute, transmute or alter the sound of thesnoring73, for at least onorganism8. The transmission of information can include material transmission to include wires and optics andtubes75 orwireless74. In another embodiment at least one indicator can be used to assess and givefeedback42 on physiology and biology or mechanical or environmental stimulus or information, and said information can be transmitted to adevice23 that can alter the physiology or biology or mechanical or environmental stimulus or other information to includesnoring76, which can be measured54 and the information transmitted to a device to include anacoustic altering device23 that can include noise cancellation computers, electrical devices,earbuds76 orearphones76 which from a distance or be located on or near at one organism can cancel mute, transmute or alter the sound of thesnoring76, for at least oneorganism8. In another embodiment the indicator device54 can have its function to include noise76 from a ventilator72 be measured and the information transmitted to a device23 to include an acoustic device23 that can include a computer or noise cancellation device or earbuds76 or earphones76, which can affect from a distance with speakers or be located on or near or at least one organism or one machine to cancel the sound76 of the machine72 which can include a ventilator72 or monitoring device, treatment device, pleasure device to include background sounds, environmental device to include an air conditioner or humidifier or dehumidifier, In another embodiment at least one indicator54 can measure and be used to include manage, adjust, regulate or assess the sound of the snoring76 which can be used manage, adjust, regulate or assess the physiologic or biologic parameters of the organism8 who is snoring76 and the audio signal can be transmitters using a method of wires75 or optics75 or wireless74 other transmitter methods or wirelessly74 or a combination of these methods, to the snoring organism or at least on other organism such that the snoring sound76 can be cancelled out using a method to include acoustic canceling or sound canceling techniques that is the preferred embodiment can be include earphones76, earbuds76, or a room speaker or microphone to cancel or minimize or mute or transmute the sound to provide a more beneficial or pleasant or acceptable sound76 to one or more of the snoring and the non-snoring individuals8. An input device for the acoustic sounds can include a microphone oracoustic receiving unit71.
• FIG. 36 is a sagital depiction of a device to capture and then simulate breastfeeding and then simulate that sensation in a breast-pumping orbreastfeeding device23. In one embodiment asensing device54 containing sensory receptors that can include pressure and touch and compression and can be used to create a signal that can include a digital or analog signal that can be stored and processed and transmitted by or into a device that can include a computer-like device78, an electrical or mechanical device that can store and process information digitally oranalog78. That information can be utilized to control a second device that can include asealing pad2, asealing pad2 with askin covering3, asealing pad2 with askin covering3 andindicator device54, afeedback device42, or a machine that can include amachine23 used for biologic and physiologic functions that can include breast feeding, pumping the breast for the extraction of breast milk, pleasurable stimuli or sensations or pain and pleasure to include or alteration of physiology or biologic functions of bodily organs to include the breasts, lips, ears, skin, mouth, rectum and anus, penis and related structures such as the scrotum, clitoris and vagina and related local structures such as the labia, toes and fingers.
• In the preferred embodiment a breast pump is configured to simulate the suction and motion of the mother's infant breastfeeding. To accomplish this the sucking motion of the infant is codified and determined by having the infant suck on a simulated-nipple that can simulate a mother's breast. Sensors are placed in and on the simulated-nipple and the suction and motions of the infant are recorded for an extended period of time and the information is transferred to a computer that can capture and store this information. When the mother is ready to pump her breasts, the computer information can be transmitted to the breast pump and the mother's breast pump sealing pad and the suctioning device of the breast pump. The computer signal will then reproduce from the stored information a simulation of the infant's suction and sucking motions. In some embodiments the scent of the infant or pheromones can be released to stimulate the mother's let down reflex that starts the flow of milk. The computer can analyze maternal breast milk parameters such as the interval prior to milk let down, the quantity of milk and breast characteristic such as temperature in order to determine the best simulated infant sucking program. This process can be used for newly nursing and breastfeeding mothers or infants or mothers or infants who are benefited by the program. The same or a variation on the same or similar device can be used to teach newly nursing infants to nurse better and can be used when an infant is transitioning from breast to bottle-feeding nipples.
• Sensations and stimuli and material applications can include wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications and non-physiologic measurements to wetness or dryness, oxygen and other gaseous levels and movement, toxin levels, electromagnetic signals, kinetic signals, light and darkness levels and vision, sound and silence, movement and stillness, pain and lack of pain, pleasure and lack of pleasure, taste sensations and lack of taste sensations; odor and olfactory sensations and lack of odor and olfactory sensations, touch both light and firm touch and lack of touch, proprioception and lack of proprioception, pressure and lack of pressure, substance levels to include drugs and medications a combination of physiologic and non-physiologic measurements.
• Other embodiments include auditory signals to include the human hearing range and above and below the human hearing range; electromagnetic signals to include infrared and ultraviolet; sensory stimulus to include heat and cold, wet and dry, pain and non-painful and pleasurable stimulation; olfactory and smell sensations to include pleasant and unpleasant odors; taste to include salt, sweet, acrid, bitter, sour, umami, pleasant and un pleasant tastes; vibration and kinetic stimulus to include pinching, piercing, hard touch, light touch, vibration, and proprioceptive stimulus. The stimuli can be used singular or multiple and can be used as one or multiple stimuli or categories. Information can be transmitted by land lines to includewires75 oroptics75 or wirelessly74. In the preferred embodiment a nippleinformation gathering device54 shape device to simulate the natural shape of a mother'sbreast79 can havesensing devices54 that can include touch and pressure wetness and motion and suction pressure sensors. Ababy8 can suck onto thesensing device54 and the touch and pressure wetness and motion and suction pressure can be recorded and stored in a device with can include a computer-like storage device. This signal can then be transmitted through the processing computer likedevice78 or to abreast pump23 or to thesealing pad2 that contains a device that assist with breast pumpingFIG. 37 that can then simulate one or more of these sensory inputs and outputs that best simulates the natural sucking sensation of the infant breastfeeding. The purpose of this is to simulate natural breastfeeding and improve the let-down reflex and the natural sensation of the infant and mother breastfeeding bond. Other sensory inputs that can be acquired and stored and transmitted and simulating during breast pumping can include the olfactory to include the scent of the infant, wetness, visual including images to include the infant breastfeeding and not breastfeeding, auditory including sounds to include the infant breastfeeding and not breastfeeding, taste including taste to include the infant breastfeeding and not breastfeeding, kinesthetic and touch including touch to include the infant breastfeeding and not breastfeeding, and other sensory input that might stimulate breast milk let-down and quantity.
• Thesealing pad2 or thesealing pad2 and theskin covering material3 or a combination of both can contain adevice23FIG. 37 to include a vibration, compressive, suction, undulating device that is contained within or on thesealing pad2 or thesealing pad2 and theskin covering material3 or the sealing pad andskin covering material3 combination can be used to simulate and mimic the input to include the suckling or breast feeding of theorganism8 to include an infant that is human8 or non-human80. In another embodiment, theinfant8 can be taught how to breastfeed or suck from a man-made nipple using a similar device to teach the infant how to bottle-feed. In another embodiment, sexual pleasure can be simulated and attained using a similar device with a shape that can include a mouth, tongue, lips, or combination of these body parts that can be used for pleasure to simulate licking, and sex to include oral sex for and on either gender and on or by anybody part8. In one embodiment the device can be a sex toy which is programmed to simulate another human8 beings sensory input and output to include touch, caress, probing, sucking, kissing, licking thrusting, ejaculating, or having an orgasm, and can be shaped like a hand, mouth, tongue, lips, penis, vagina or anus.
• FIG. 37 is a close-up frontal view of thesealing pad2 of the breast pump seal or stimulating device. The sealing pad can include a gel or a non-gel material. In the preferred embodiment the seal is composed of a gel and can include adevice23 to include a mechanical device to includevibration81, acompression82 or apressure82, arotation83, undulating84 or a length changing85, stroking, licking, fluid delivery, suction device, warming or cooling or other sensory simulating or creatingdevices23.
• FIG. 38 is a frontal depiction of a communication device that can utilize be used with or without a sealing pad or thesealing pad2 and theskin covering material2 and can include anear device76 that can includeearbuds76 orearphones76, that can include containing anauditory device23, which can include and anindicator54 or measuringdevice54 orfeedback device42 to include anoise73 enhancement ornoise73cancellation device23 or an acoustic amplifier orequalizer device23 or adevice23 for changing the pressure in the airway or adevice23 for altering and measuring and feeding back information to alter gas exchange or pressure of a gas or gas or pressure a delivery system that can include allowing two individuals to communicate in a highstimulus noise environment73 to include anoise73 filled travel mode to include an airplane, car, boat, or train, or a noise filled work environment or in an environment with changing pressure to include in an airplane flight or other environments that have changing pressure or changing theexternal stimulus73 that can include but is not noise cancellation or sound or acoustic equalization or acoustic amplification. In another embodiment (not depicted) anearplug102 or a headphone-like device76 that can contain aconduit16, orreservoir41, or an electrical device that contains a pressure altering bellows, diaphragm or membrane, one or more than one chambers or adevice23 that contains a valve that slowly allows an adjustment to the pressure to equilibrate the pressure relative to the inner ear pressure, the outer ear pressure and the atmospheric pressure of the user. In another embodiment theacoustic device23 and thepressure control device23 can be used together. In the preferred embodiment thesealing pad2, or a combination of sealingpad2 and the skin covering3 can include anearbud76 orearphone76 that can contain anauditory unit device86 that can include a speaker oracoustic delivery system86. Thedevice23 can include adevice23 to include an auditory unit or computer likedevice78 for amplifying sound, equalizing sound, subtracting sound, altering sound, increasing or suppressing sound, and modifying sound. The device can include an analog, an auditory analog to digital converter, a purely digital unit and can beland lines75 to include wires and fiber optics and withwireless74.
• The device can be an auditory unit that ishard wire75 connected to another device that promotes auditory communication such as an electronic device that has input and output capabilities to communicate with one or multiple individuals. Some uses can include airplane travel, operating room communication, hospitals, old age homes, subways, buses, trains, manufacturing and non-mechanical. In the preferred embodiment the sealing pad or the sealing pad and skin covering material can include anearbud listening device76 andspeaker86 and amicrophone71 receiving auditory device, theinput microphone71 can together with or can be separate from theoutput listening device76. This communication method can be used on a vehicle or on anoisy environment73 to include a train or boat or car or airplane where the ambient noise is very high and can be damaging to the ears and speaking to an individual often involves turning the head to the individual which at the end of the travel can result in a stiff neck and a hoarse voice At least oneorganism8 can speak into themicrophone71 and the audio signal is processed by an audio processing and modulatingdevice23 which can amplify the voice or noise cancel the non-voice audio signal using standard methods for amplification ofvoice87 and noise cancellation of the non-voice auditory signals73. Thedevice23 then transmits the signal to at least oneorganism8 who can then listen and speak to at least oneorganism8 using a similar mechanism and device such that the receiving and sending audio signal can be shared by at least oneorganism8. In one embodiment this device can be an accessory for or be built into acomputer78 or computer-like78, MP3 or digital music device to include an IPod-like device88, iPod-like device, cell phone-like device or walkie-talkie like device. In another embodiment theauditory modulating device23 can be incorporated in thesealing pad2 and or thesealing pad2 andskin covering material3 or the device can be external to thesealing pad2 and or thesealing pad3 andskin covering material3 and obtain input from an external source that can be delivered throughland lines74,tubes16 orwireless74 methods.
• FIG. 39 is a sagital depiction of a noseplug sealing pad2 or sealing pad and skin covering material or skin covering3 without asealing pad2 that can include a nasal mask, which can include zero, one or more than one channel orconduit16 and include delivery system for solids, liquids, gels or gases or a combination of these elements. The nose plug seal can include containingreservoirs41,conduits16, electrodes or semiconductorsensation stimulating devices70 and devices that can include filters, fans and sensory stimulants and delivery systems, and impregnated40 substances into the sealingpad nose plug2. In one embodiment, thenasal plug2 ormask3 can include anolfactory device23 that can deliver the scent of theinfant8, and can be used to include use during breast pumping to deliver the scent of theinfant8 to stimulate the mother's8 let-down reflex. In another embodiment, thenasal plug2 ormask3 can include anolfactory device23 that can deliver the scent of amother8 or afather8 to apremature infant8 in an incubator or in isolation such that the infant received sensory stimulation to bond with one ormore organisms8. In another embodiment, thenasal plug2 ormask2,3 can include a sensory device worn at the movies that can deliver a sensory input that can include the use of a mask that can deliver an olfactory input. In another embodiment the nasal plug ormask2,3 can include at least one reservoir that provides for nearly or unimpeded inflow of air and with impeded outflow of air that increases the airway or air resistance to the outflow of air. The reservoirs which can expand or contract can be arranged to increase outflow air resistance in a steady or a variable manner and in a manner in which the pressure is greater or is lesser near the user relative to the external environment. The device can be composed of at least one valve that controls the inflow and outflow of a substance to include a solid, a liquid, a gel or a gas to deliver or to remove or maintain a substance to include a scent, air pressure, oxygen and other gases, or an olfactory stimulant or stimulatingdevice70 or smell, and air resistance. The reservoir and valve can be used to include being used separately or together or in any combination. Thevalve89 or thereservoir41 delivery can be mechanical or non mechanical.
• FIG. 40 A is a frontal view and40 B is a sagital view of a low profile flexible swimming goggle. In the preferred embodiment the swimming goggle can use agel sealing pad2 and a skin covering3 that surrounds theeyes92 and has a skin covering material a portion that is overlying theeyes92 is flush or nearly flush with the face andskin1 and follows the contours of the face andskin1. Theskin covering3 can be being transparent and can include containing at least a component that is fabric that acts as a Zorro-like mask the mask fits around the back of the head or around the ears or a combination of the back of the head or theears91. Theeyepiece90 is flush or nearly flush with the face andskin1 and the mask skin covering3 and follows the contours of the face andskin1. The sealing pad can be gel or non-gel and in the preferred embodiment is gel. Thesealing pad2 lies between theskin covering material3 and the skin and provides an airtight and watertight seal that contours and conformed to the face andskin1.
• FIG. 41 is a close up top view of thesealing pad2 and theskin covering material3 that can include a goggle oreye92 protection that can be airtight and watertight or non-airtight and watertight and can be gel or non-gel. Thesealing pad2 conforms and contours to the facial contours andskin1 and in the preferred embodiment causes the skin covering to be flush or nearly flush with the facial contour andskin1. In the preferred embodiment the goggle is airtight and watertight and the preferred method by which the goggle is flush or nearly flush with the facial contour andskin1 includes asealing pad2 that varies inthickness95 and includes it being thicker95 in some regions than in other regions to include asealing pad2 that is thicker away from theeyes92 than near theeyes92. Since the facial shape of individuals varies greatly thethickness95 is designed to vary to conform to the contours to include different ethnicities, races and phenotypic facial contours. In another embodiment the skin covering can include asealing pad2 or a skin covering3 or any combination of these elements that is thicker in some regions than inother regions95 to include a skin covering3 that is thicker away from theeyes92 than near theeyes92 or that is thicker near theeyes92 than away from theeyes92 or thicker95 near the cheek orskin1 than the brow of the face andskin1 or thicker away from the cheek orskin1 than the brow of the face andskin1 or thicker near theskin1 than away from the face andskin1 or thicker away from theskin1 than near the face andskin1 or thicker near the nose than away from thenose93 or thicker away from thenose93 than near thenose93. Thesealing pad2 and the skin covering3 withvariable thickness95 can include the sealing pad and the skin covering being used alone or in any combination. Theeyepiece90 can be constructed to include it being part of the skin covering3 or part of thesealing pad2 or a combination of it being continuous or part of the skin covering3 or continuous or part of thesealing pad2. Theeyepiece90 can also be separate from thesealing pad2 or separate from the skin covering3 or a combination of separate and combined. Theeyepiece90 can be attached or integrated into the skin covering3 orsealing pad2 to include adhesives, hooks, Velcro, loops, ties, pins, protuberances and invaginations, sewing, molded or woven into the interstices of the skin covering3 orsealing pad2 or into a gasket or frame-like structure that is intimately constructed with at least a portion of theeyepiece90 but remains flush or relatively flush with the users face orskin1. The advantage and goal of this design is to reduce water drag and resistance and to be comfortable and stylish. In another embodiment, theeye goggles3 ormask3 can be one continuous flexible material, which can include a gel that can include a gel that varies in hardness andsoftness94. Thesealing pad2 or skin covering3 can include it being softer near the uses face orskin1 than away from the users face or softer away from theusers nose93 than near the users face orskin1 or thesealing pad2 can include it being softer near theuses nose93 than away from theusers nose8 or softer away from theusers nose8 than near theusers nose93 or thesealing pad2 can include it being softer near the uses cheek orskin1 than away from the users cheek orskin1 or softer away from the users cheek orskin1 than near the users cheek or any variation or combination of these elements. In another embodiment, theeye goggles3 ormask3 can be one continuous flexible material with aseparate eyepiece90. In another embodiment, theeye goggles3 ormask3 can be one continuous flexible material with aseparate eyepiece90 and aseparate sealing pad2. The goggle skin covering3 can include a fabric a plastic, fiberglass or polymer or gel that can include a gel that varies in hardness andsoftness94 and transparency. In another embodiment, theeye goggles3 ormask3 can be one continuous flexible material with a separate or acontinuous sealing pad2. The embodiments of thesealing pad2 and the skin covering described and discussed inFIGS. 40 and 41 and eye goggles and eye masks but can include application and masks that include nasal masks, oral or mouth masks, breathing masks, auditory or hearing or ear devices, urinary devices, penile, vaginal and anal or embryologic or surgical skin covering3 orsealing pad2 or combination of these elements. Thesealing pad2 and the skin covering can be combined to provide a unique method of variability to include combinations ofvariable thickness95 and variable hardness andsoftness94.
• FIG. 42 is a frontal view of aneyepiece90 that displays98 or projects a sensory signal that can includeblood flow60 from a measuringdevice54 to a feedback ordisplay projection unit42 to include an electromagnetic signal in the visible range or outside of the visible range to be utilized with a user wearing aneye device23 which can include asealing pad2 and askin covering material3 to includeswimming goggles96, protective eyewear, workout glasses, sun-tanning eyewear or sporting eyewear for use with skiing, swimming, beach volleyball and ball and racket and biking and running sports. Signals can be sent by hard wiring to include wires, cables andoptics75 or wirelessly74. In the preferred embodiment theeyepiece90 with a viewer or a projector that can be used with asealing pad2 or askin covering material3 or any combination of these elements. Theeyepiece90 can include a screen that can be transparent, translucent or opaque and transmit any combination of no light or maximal light and can incorporate adisplay98 or feedbacksensory device42 to include a projector or camera or sensation creating device to include an analog or digital to include an LED, a light projector, a retinal display, a screen that becomes visible with electromagnetic energy projected onto a material that can respond to chemical, kinetic energy and electromagnetic energy to include visible light, ultraviolet light and infrared light. Information can be displayed on the screen that can provide feedback to include the form of the user swimming, physiologic information, or information from a non-user source that can include temporal information, sport related information to include lap number, physiologic information, instructional information, entertaining information, educational information. The transmission of the information can bewireless74, or hard-wired75 to include optics or wires or tubes.
• In one embodiment a physiologic indicator or measuring ormonitoring device54 can be attached to thegoggle96 unit to monitor physiology to include blood pressure and pulse and carbon dioxide, or lactate or oxygen saturation levels that can be acquired from the vascular60 flow to include the temporal artery. In another embodiment information the information can be transmitted from abody8device23 to include a watch or watch-like device97 that can provide any combination to include vascular60 information, physiological information, or sport related information. Information can be transmitted for a sensing or measuring orindicator device54 and transmitted to afeedback device42 that can display the information visually or can give a sensory feedback that can include a visual, auditory, olfactory, touch-like, or taste sensation. The material that is displayed can be physiologic and non-physiologic and can include feedback, instructional, entertainment, educational or any other forms of visual media and can be combined with auditory and other sensory inputs.
• FIG. 43 is a frontal view of an eye-viewingdevice100 that can be used with amedical device23 that traditionally has a screen such that the user has to turn their neck orbody8. In the preferred embodiment, themedical machine99 would include anUltrasound machine99. The Sonographer can wear a pair of viewing eye goggles or a mask orglasses100 that can project theultrasound99 image onto aneyepiece90 or directly onto the retina while the Sonographer is scanning the patient. Currently the Sonographers have to continuously turn their heads to theultrasound99device99 and back to the patient. Sonographers are prone to develop herniated discs and degenerative diseases in their necks and spasms and muscular difficulties in their shoulders. The method of the transmission of theultrasound99 signal from the machine to the eye viewing devise100 can includewireless74 or hardwired75 to include wires, optics or other means of transmission electromagnetic signals. In the preferred embodiment the transmission will bewireless74. Other uses for medicaleye viewing devices100 can include robotic surgery, angiography and catheterization procedures, endoscopy and medical and surgical procedures that require ancillary screen viewing. In another embodiment, eye goggle ormask viewing devices100 can be combined with asealing pad2 and askin covering material3 to be used in a surgical field or in an emergency field or battlefield or in a situation where toxic or infectious or dangerous biologic or non-biologic agents are present and there is a need to view ascreen98 and keep attention focused on a task in a viewing plane different than aviewing screen98 and where a part of the body to include abody part8 to include the eyes, nose or mouth or an opening or cavity in the superficial skin needs to be protected.
• FIG. 44 is sagital depiction of a sealing pad that containsinclusions101. In the preferred embodiment, thesealing pad2 or asealing pad2 with askin covering material3 can contain a material within thesealing pad2 which can be composed of a gel or a non-gel material and theinclusions101 andreservoirs41 channels orconduits16 that pass through at least a portion of thesealing pad2, and impregnations40 can include a solid or liquid or gas or another gel. Theinclusions101 can include nanotechnology and nanoparticles that can include nanotubes and can include nanoparticles that are fine particle at 100-2500 nanometers (nm) or Ultrafine at 1-100 nm. The preferred embodiment can be used for anorifice37device23 to include anear plug102, nose plug, intubation device, anal or vaginal device for a seal in which to create greater buoyancy, can deliver substances to include medication, gas, detoxifying agents, or to serve as acoustic reflectors or absorbers, or to alter the cushioning or the hardness orsoftness94 of thegel sealing pad2 or adapt to pressure changes to include pressure changes that occur while swimming, diving and flying in an airplane.
• FIG. 45 is a sagital depiction of asealing pad2 or asealing pad2 and askin covering material3 and which can be composed of a gel or a non-gel material and which can contain conduits or channels through at least a portion of the sealing pad which in the preferred embodiment is anearplug102. Thechannels16 can include contain valves for equalizing the inflow and the outflow of pressure and can have graduated pressures at which the valve gives way and allows for the equalization between the atmospheric pressure within the space between thesealing pad2 and the user, the inner chamber and the space external to thesealing pad2 and external to the user. The channels orconduits16 can traverse at least a portion of thesealing pad2 and can deliver a substance that can be a solid or a liquid or a gel or a gas. The channels or conduits can traverse at least a portion of thesealing pad2 and can contain a device that can include an audio device that can include askin covering3 material which can include speakers or acoustic86, or electromagnetic energy delivery or reception devices. Thesealing pad plug2 which in the preferred embodiment is composed of gel or a non-gel can contain a sensing device that can reside within the gel or on the surface of the gel or within the channel and measure body and physiologic functions to include sound, temperature, and movement to include tympanography. Thesealing pad2 can include containingflanges4 on the outside within thesealing pad2 orskin covering3.
• FIG. 46 is a sagital depiction of asealing pad2 or agel sealing pad2 and askin covering material3 or afixation device11 or any combination of these elements that protects breast tissue that can be use for the purpose of tender breasts and nipples during maternal-infant breast feeding, after surgery, during or after chemotherapy or radiation therapy, during or after learning how to wear a bra, after trauma, or injury, alter sensation for comfort or pleasure. Thesealing pad2 can include be used to protect or cover the nipple and breast tissue or a combination of thesebody parts8. Thesealing pad2 can include at least oneskin covering material3. Thesealing pad2 can be but does not have to be airtight or watertight.
• Thesealing pad2 can be a gel or a non-gel. Thesealing pad2 orskin covering material3 can be annular or non-annular. Thesealing pad2 orskin covering material3 can contain one or more than one fenestration. Thesealing pad2 orskin covering material3 can include being coated or impregnated with a substance to include anti-viral or anti-bacterial or anti-fungal or anti-germ and disease materials, an anti-inflammatory, a cooling material, an anesthetic, a flavoring material, substance or medication for the offspring, substance or medication for the living creature with the breast such as substance or medications that reduce radiation treatment affects. Thesealing pad2 or skin covering material can include containing areservoir41 that can contain or be coated with or impregnated with a substance to include anti-viral or anti-bacterial or anti-fungal or anti-germ and disease materials, anti-inflammatory, a cooling material, an anesthetic, a flavoring material, substance or medication for the offspring, substance or medication for the living creature with the breast such as substance or medications that reduce radiation treatment affects. The breast shield can contain a device that can include a device that can change sensations to include heating and cooling, moistening or drying, or altering pain and pressure and touch sensations; amplifying sound or delivering electromagnetic energy to includeultrasound99, infrared, ultraviolet, or magnetism, chemical energy, kinetic or Brownian energy to include vibration, heating and cooling, stimulation or sensory receptors and vascular flow.
• Thedevice23 can be an analog or digital and can be hard wired or wireless. The device can include containing areservoir41 or tubes orconduits16 or can be impregnated with a solid or liquid or gel or gas or any combination these elements that can alter biology or physiology. The device can be mechanical or non-mechanical and include HEPPA filters, specific agent detoxifying or anti-germ filters, a substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying agent or filter; heating or cooling122 device, alter the pressure relative to the ambient air, a small fan, a mechanical filter, a small heater or cooler, alter pressure, HEPPA filters, specific agent detoxifying or anti-germ filters, a substance or medication can include agents that are antibiotic, antibacterial, antifungal, antiviral; anti-fogging; scented; detoxifying agent or filter; heating or cooling122 device, alter the pressure relative to the ambient air. The device can be a nanotechnology device to include a device that serves as an air filter, anti-germ agent and detoxifying agent, defogging agent, heating and cooling, alter the pressure or compression. The breast shield can include containing indicators or measuringdevice54 andfeedback devices42 ordevices23 for monitoring parameters to include sensory data to include temperature, color, and oxygen consumption and the ability to respond to these parameters by releasing substances mechanically or automatically to include medications, orvibration81 or electric stimulation. In another embodiment thisdevice23 can be used to treat other body parts ororgans8. In another embodiment the alteration of the biology or physiology can for create pleasure or sexual stimulation.
• FIG. 47 is a sagital depiction of askin covering material3 that can have a smaller circumference at one end than another end to be used with asealing pad2. In one embodiment theskin covering material3 can have a smaller circumference at thesealing pad2 than away from thesealing pad2. In the preferred embodiment, thesealing pad2 andskin covering material3 can be used as a wound cover. In another embodiment the skin covering3 can have characteristics similar to ashower cap3, and can include an elastic material that bunches104 one end of thesealing pad2 and has a smaller circumference to conform to thesealing pad2 while the remainder of thesealing pad2 has a larger circumference to conform to alarger body part8 that can include a the head, hand, foot, arm, leg, torso or appendage that can include the penis or finger. Theskin covering material3 can include containing an elastic material, a fabric, an elastomeric gel, latex, a rubber-like material, a polyurethane that can include stretching, bunching104, expanding, contracting that can be resiliently deforming or non-resiliently deforming. In one embodiment theskin covering material3 can have a larger circumference at thesealing pad2 than away from thesealing pad2. In one embodiment theskin covering material3 can have an equal circumference at thesealing pad2 than away from thesealing pad2.
• The combination of thesealing pad2 and theskin covering material3 of with these embodiments can include a shower cap, a cast cover, a wound cover, a breathing and intubation mask and device, adevice23 covering that can include adevice23 cover that is associated or intimate with theskin1; abody8 cover that can include an appendage cover that can include a condom, a finger cover, an organ cover that can include an organ within a cavity or orifice or surgical site.
• FIG. 48 is a frontal view of anasal device23 that can be used to open at least one or more nostrils and thenares108 or the nasal passages. One embodiment can include a device the fits into the nares and widens the diameter of the nares that can include containing noskin covering material3 or containing askin covering material3 that can adhere to theskin1 through standard methods to include adhesives and tackifying agents. The skin covering material can be a connector between the adhesive and thenares separating device23. In another embodiment the nares can be widened by a nares device can be place inside of the nares on the lateral inner portion of the nares and that nares device can be attached to a skin covering material that can stretch or maintain the nares and nasal passages in a more open position that can be attached to the skin that can include a region near the junction of thenose93 and thecheek107 and can be adhered to theskin1 through standard methods to includeadhesives106 and tackifying agents. Thenares separating device23 can contain agel sealing pad2 that can be but does not have to be airtight and watertight.
• FIGS. 49A and 49B are a frontal depictions of a nasal device that can be used to open the nares and nasal passages. In another embodiment a band orstrap114 can be placed around the head orears91 or a combination of thesebody parts8 and the ends of the band orstrap114 can be attached directly to thefacial skin1 that can include attachment point near theskin1 of thecheek107 orouter skin1 of thenose93 or near the junction of thecheeks107 andnose93 or any region or combination of these regions. There can be one or more than one attachment points and straps114. In another embodiment the strap orband114 can be combined with the device that resides inside of the nares as depicted inFIG. 49 and the methods ofFIGS. 49A and 49B can be combined.
• FIG. 49B depicts a nostril or nares likedevice23 that opens the nares to improve breathing. This embodiment can include an annular or non-annular structure that resides within nostril and increases or keeps the inner diameter of the nostril open or expanded. In the preferred embodiment the structure is annular and can have an extension or shelf like structure or lip-like structure orrim109 that prevents the structure from extending too far into the nostril. In another embodiment the nostril device.
• FIGS. 50A and 50B are a frontal views of askin covering material3 that forms awound105 closure device and method. In the preferred embodiment theskin covering material3 wound105 strips are composed of strands that can include being composed of anelastomeric strip material110 to include an elastomeric gel, rubber, latex, or fabric to include strips. The elastomericskin covering material3 can include one or more than oneelastomeric strip110 of material and can be used in combination of non-elastomeric skin covering3 materials to include a fabric to include fibers, organic materials that can include wood and plant products, synthetic materials. Theskin covering material3 can adhere to theskin1 through standard methods to include adhesives and tackifying agents.
• This embodiment creates a tension that can hold thewound105 closed and this differs from steri-strips that hold thewound105 in place without tension. The usefulness of closing thewound105 with tension is to place tension in specific locations of the wound. This new form of tension wound closure skin covering3 combined with the traditional steri-strip closures can assist assisting in the actual closure of the wound, healing, reduce infection because of earlier healing and intention and can more effective create closure of thewound105 and can reduce scars113.FIG. 50B depicts one theory on scar formation which is that ascar113 are more likely to form when thewound105 closes with atrough112 with ashadow112 than abump114 with no shadow because of the manner that light reflects off of the wound.
• FIG. 51 is a frontal view of anapplicator118 orexpander118 that can be placed within asealing pad2 to assist in the application of thesealing pad2 onto a body part. There can be a challenge of placing asealing pad2, askin covering material3, afixation device11, ananchoring device35 or any combination of these elements onto or in abody part8 that can include a user that has a broken hand or arm and has limited use of that limb, or to insure that that thesealing pad2, askin covering material3, afixation device11 or any combination of these elements does not bunch up or tangle when being applied to thebody8. The use of anapplicator118 orexpander118 can facilitate the placement of thesealing pad2, askin covering material3, afixation device11 or any combination of these elements onto thebody8. Theapplicator118 can be annular or non-annular. Theexpander118 andapplicator118 can have a geometric or a random shape and can have zero, one or more than one protuberance or invagination. In the preferred embodiment theapplicator118 andexpander118 can be a circular structure that is annular and provides for an appendage to fit through the hollow of theapplicator118. In one of the preferred embodiments theapplicator118 is a simple cylindrical or annular structure. In the preferred application theapplicator118 can be used as a cast cover that has a circumference or a diameter or a length greater than the cast and therefore can provide for the application of the cast cover over the cast without undo effort. Theapplicator118 can include an annular structure that is a shallow cylinder that can be being as wide, equal to or less wide than thesealing pad2. Theapplicator118 can lie within or be within or lie outside of thesealing pad2. In the preferred embodiment theapplicator118 lies within the inner circumference of thesealing pad2 and expands that sealingpad2 and the skin covering3 to allow thesealing pad2 and the skin covering to fit over thebody part8 that can include an appendage that can be associated with zero or one or more than onedevice23 to include a cast or monitor or feedback or measuring or delivery device. Theapplicator118 can be composed of a material or structure that can expand, contract or remain the same size. Theapplicator118 can be formed from a substance or coated by a substance or be combination of substances that can have a coefficient of friction that is equal to, less than or more than thesealing pad2 or theskin covering material3 and or can have any combination of these element.
• The application device can include substances that reduce friction that include materials that include Teflon, oils ultra-hard carbon film, near-frictionless carbon (NFC), MoS2, smooth diamond and diamond-like carbon films, or natural diamond and highly polished metals to include polished steel, a substance with a friction close to thesealing pad2 or the skin covering which can include a substance that is the same as thesealing pad2 or skin covering3 or a substance with an increased friction relative to thesealing pad2 or skin covering3 that can include a rubber, roughened surfaces or vertically aligned polymer micro-fibers that can include being each less than a micron in diameter and 20 microns high. Another method to assist in efficient application of thesealing pad2 andskin covering material3 onto and off of theapplicator118 can include to have zero, one or more than one form of projections or invaginations on theapplicator118 or thesealing pad2fixation device11, or the skin covering material. Another method to assist in efficient application of thesealing pad2,fixation device11, andskin covering material3 onto and off of theapplicator118 can include to have zero, one or more than one transitional materials to reside between theapplicator118 and thesealing pad2 orskin covering material3fixation device11 or any combination of these elements. The removal of thesealing pad2 andskin covering material3 form theapplicator118 can include mechanical methods to include sliding, pulling116, rolling, pushing, wiggling, zipping, snipping, twisting, unhooking, unbuttoning and popping thesealing pad2,fixation device11, andskin covering material3 or theapplicator118 or any combination of these elements apart relative to each other. In another embodiment theapplicator118 can be composed such that it has afastening115 device that can be unfastened115 that can include a minor geometric or random shape that can be unfastened115 by means to include mechanical means to include sliding, pulling, rolling, pushing, wiggling, zipping, snipping, twisting, unhooking, unbuttoning and popping thesealing pad2,fixation device11, andskin covering material3 or theapplicator118 or any combination of these elements.
• In the preferred embodiment theapplicator118 can include a plastic annular cylinder that is of greater diameter than thesealing pad2,fixation device11, andskin covering material3 such that these elements are stretched to a diameter fitting comfortably over theapplicator118. Theapplicator118 is annular and has afastening115 mechanism. Theapplicator118 has a diameter greater than the diameter of the cast cover or the appendage over which thesealing pad2,fixation device11, andskin covering material3 andapplicator118 must fit. Thesealing pad2,fixation device11, andskin covering material3. Thesealing pad2,fixation device11, andskin covering material3 can be fitted over the cast cover and the appendage and put into a position such that thesealing pad2,fixation device11, andskin covering material3 andapplicator118 are proximal to the cast and reside over the skin proximal to the cast. Once in position thefastener115 of theapplicator118 which is a mirrored geometric configuration is pulled apart and theapplicator118 is gradually removed leaving thesealing pad2,fixation device11, andskin covering material3 or any combination of these elements in position against theskin1 and creating a watertight or airtight seal. Theapplicator118 is removed. Theapplicator118 can be used once, more than once making it reusable or thesealing pad2,fixation device11, andskin covering material3 or any combination of these elements can be placed onto the skin without anapplicator118. In another configuration theapplicator118 can reside within a fold of thesealing pad2,fixation device11, orskin covering material3 or any combination of these elements.
• FIG. 52 is a sagital view of a device to deliver medication through the skin to a sub dermal or subcutaneous structure. In one embodiment thesealing pad2,fixation device11, anchoringdevice35reservoirs41 orskin covering material3 or any combination of these elements can contain a medication delivery device that hasindicator54 orfeedback device42 to regulate to include the energy and the medication or any combination of these elements. In the preferred embodiment thesealing pad2 is attached to an appendage which can include abody part8 to include a finger ortoe121. In the preferred embodiment thenail119 of the finger or toe has a fungal infection that resides in thenail119 and in the growth plate of thenail119 known as thematrix120. To treat thenail119 and remove the fungus it is postulated that thematrix120 must be eradicated of the infection. In the preferred embodiment thegel sealing pad2 rests on thematrix120.
• An energy delivery or activatingdevice117 to deliver a form ofenergy9 to include chemical, electromagnetic123 or kinetic or Brownian energy or a substance to include a solid or liquid or gel or gas, which can be held in place by thesealing pad2,fixation device11, anchoringdevice35reservoirs41 orskin covering material3 or any combination of these elements and the device can reside with these elements or between these elements and the skin or nail119 bed or external to the nail and skin and these elements. The device can utilize a treatment to include a chemical reaction, anenergy source117 to include chemical energy, electromagnetic123 energy, kinetic or Brownian energy. An indicator or measuringdevice54 and afeedback device42 can be used to assess the energy delivery and the biological effects of the delivery of the chemical reaction or energy reaction on the biological system. In one embodiment energy alone can be used to alter the biology, which can include treating the infection, sterilizing, reducing aging effects, or promoting biological or physiological wellness. In another embodiment asubstance9 which can be a solid, liquid, gel or gas can be applied to theskin1 which can be superficial or in a cavity to include the peritoneal lining or the fascia or the adventia or serosa of an organ orbody structure8 or orifice to include the mucosa or amembrane1 or can be placed deep to the skin or mucosa ormembrane1. In one embodiment this can create a chemical reaction and thesealing pad2 can control the environment between thesealing pad2 and the skin which overlies thebody structure8 to include the epidermis, mucosa or a membrane or the adventia or serosa of an organ or fascia or anail119. In another embodiment anenergy source117 can be used alone or anenergy source117 and asubstance9 which can be a solid, liquid, gel or gas can be used together to alter biological or physiological function to include treating the infection, sterilizing, reducing aging effects, or promoting biological or physiological wellness. In the preferred embodiment the substance can include micro-particles orinclusion101 bodies that contain a substance that can penetrate the skin using and energy source to includeultrasound99.
• FIG. 53 A is a sagital view agel sealing pad2 with a method for altering itsphysical properties124 to include the hardness andsoftness94 andthickness95 of thesealing pad2. In one embodiment thesealing pad2,fixation device11, anchoringdevice35 orskin covering material3 or any combination of these elements can be composed a material to include a gel or solid that has the ability to alter itsphysical properties124 to include its hardness andsoftness94, itsthickness95 or length or width, its coefficient of friction, or its repair capabilities, or any combination of theseproperties124. In one embodiment the sealing pad2, fixation device11, anchoring device35 and skin covering material3 the indicators54 or feedback device42 or any combination of these elements can be composed a material to include a gel or solid that has the ability to alter physical properties124 to include its hardness or softness94 or thickness95 coefficient of friction or length and width or any combination of these properties124 using a method or device to include a heating or cooling122 unit, or a reservoir41, or can have impregnated materials that can be a solid or liquid or gel or gas and can be formed from a material to include an elastomer to include a thermoplastic elastomer, gel, rubber, latex, and metals polymer and alloy materials to include temperature-responsive polymers which are materials which undergo changes upon temperature changes, smart metals to include Nitenol and shape memory alloys and non-metal shape memory polymers in which large deformation can be induced and recovered through temperature changes or stress changes and martensitic phase changes, piezoelectric materials that produce a voltage when forces or stress are applied resulting in structure altering shape to include bend, expand or contract when said voltage is applied, shape memory alloys and shape memory polymers which can have large deformations which can be induced and recovered through temperature changes or stress changes (pseudoelasticity), magnetostrictive materials which can change in shape under the influence of a magnetic123 field and can exhibit a change in their magnetization under the influence of mechanical stress, magnetic123 shape memory alloys which are materials that change their shape in response to a significant change in a magnetic123 field, pH-sensitive polymers which are materials that change in volume and shape when the pH of the surrounding environment changes, halochromic materials which can change their color as a result of changing acidity which can also be used as indicators to include condoms which can include a sensor to detect a breech in the condom integrity or intubation devices to include a sensor to detect whether gastric reflux or aspiration has occurred or wound covers that can include detect infectious agents that change the pH of the wound to include bacteria, fungi, viruses and other infectious pathogens, chromogenic systems which can change color in response to electrical, optical or thermal122 changes which can include electrochromic materials, which change their color or opacity on the application of a voltage to include liquid crystal displays, thermochromic materials change in color depending on their temperature, and photochromic materials, which change color in response to light, ferrofluids, photomechanical materials change shape under exposure to light, Self-healing materials125 have the intrinsic ability to repair damage due to normal usage, thus expanding the material's lifetime, dielectric elastomers (DEs) are smart material systems which produce large strains under the influence of an external electric field, magnetocaloric materials are compounds that undergo a reversible change in temperature upon exposure to a changing magnetic123 field, Thermoelectric materials are used to build devices that convert temperature differences into electricity and the reverse or other electromagnetic123 sensitive materials that can alter their physical properties when exposed to electromagnetic123 energy including ultraviolet and infrared sources or chemical reaction energy, kinetic energy including vibration or chemical reactions including chemical bonding methods; and nonotechnology. In one embodiment to include a device for intubation, cast cover, wound cover, environment cover, urination collection and disposal, sexual stimulation, sexual and erectile function and orgasm and gratification, fecal and body waste disposal, eyewear and goggles, breathing masks and intubation devices and masks, nasal and ear devices to include olfactory and auditory devices, surgical cavity and body organ protection and isolation, isolation chambers, and infection treatment and aging treatment as well as other physiologic and biologic functions that are assisted by an effective seal which can be airtight and watertight or not airtight and not watertight which are composed of agel sealing pad2 and a skin covering3 in which thegel sealing pad2 or the gel sealing pad andskin covering material3 incorporate a method for altering their physical properties to include altering the hardness andsoftness94 andthickness95 of thesealing pad2 in response to the compression or pressure or the airtight and watertight seal required produced on or upon thelocal skin1, mucosal tissue ormembranes1 andorifice lining skin1. In one embodiment this embodiment thesealing pad2 composed of a thermoplastic polymer, a magneto-sensitive material, or an electromagnetic123 sensitive material that can include a gel.Indicators54 andfeedback42 devices can be positioned on or in or near or distant to thesealing pad2 orskin covering material3 orfixation device11 or theanchoring device35 or any combination of these elements. In the presence of a physiologic or biologic stimulus or event that can include gastric reflux, aspiration, a decreased airtight or watertight seal, adverse pressure on thelocal mucosa1 or skin of theinternal cavity1 or theexternal skin1 or adverse positioning or pressure on the larynx, the indicator or measuringdevice54 can feedback a need to alter the physical property of thesealing pad2 in the preferred embodiment but can includesealing pad2,fixation device11, anchoringdevice35 andskin covering material3 or any combination of these elements. In one embodiment afeedback device mechanism42 can be present but does not have to be present and which can automatically produce or initiate and can also turn off or vary or modulate a stimulus that can include a thermal122 device, an electromagnetic123 device, or a chemical device or any combination of these elements. In the preferred embodiment a heating or magnetic123 unit can be can be positioned on or in or near or distant to thesealing pad2 but can include thesealing pad2, skin covering3,fixation device11, anchoringdevice35, theindicators54 orfeedback device42 or any combination of these elements such that thesealing pad2 which can include a thermosensitive gel, or thermoplastic elastomer can have itsphysical properties124 altered which can include thegel sealing pad2 which is within the oral or pharyngeal cavity can have itsphysical properties124 altered which can include the gel sealing pad becoming softer or harder94 or thicker95 or thinner or longer or shortened in response to the physiology or biology needs of the user. The alteration of the physical characteristics can also be manually controlled by the user or the non-user in or upon whom thesealing pad2 is employed.
• FIG. 54 is a frontal view of condom that can alter its physical characteristics to include sealing pads2, skin covering materials3, fixation devices11, anchoring devices35, indicators54 and feedback mechanisms42 can be composed of materials that can be a solid or liquid or gel or gas that can be formed from zero or at least one or more materials to include materials that alter their physical properties124 to include temperature-responsive polymers which are materials which undergo changes upon temperature changes, smart metals to include Nitenol and shape memory alloys and non-metal shape memory polymers in which large deformation can be induced and recovered through temperature changes or stress changes and martensitic phase changes, piezoelectric materials that produce a voltage when forces or stress are applied resulting in structure altering shape to include bend, expand or contract when said voltage is applied, shape memory alloys and shape memory polymers which can have large deformations which can be induced and recovered through temperature changes or stress changes (pseudoelasticity), magnetostrictive materials which can change in shape under the influence of a magnetic123 field and can exhibit a change in their magnetization under the influence of mechanical stress, magnetic123 shape memory alloys which are materials that change their shape in response to a significant change in a magnetic123 field, pH-sensitive polymers which are materials that change in volume and shape when the pH of the surrounding environment changes, halochromic materials which can change their color as a result of changing acidity which can also be used as indicators to include condoms which can include a sensor to detect a breech126 in the condom integrity or intubation devices to include a sensor to detect whether gastric reflux or aspiration has occurred or wound covers that can include detect infectious agents that change the pH of the wound to include bacteria, fungi, viruses and other infectious pathogens, chromogenic systems which can change color in response to electrical, optical or thermal122 changes which can include electrochromic materials, which change their color or opacity on the application of a voltage to include liquid crystal displays, thermochromic materials change in color depending on their temperature, and photochromic materials, which change color in response to light, ferrofluids, photomechanical materials change shape under exposure to light, Self-healing materials125 have the intrinsic ability to repair damage due to normal usage, thus expanding the material's lifetime, dielectric elastomers (DEs) are smart material systems which produce large strains under the influence of an external electric field, magnetocaloric materials are compounds that undergo a reversible change in temperature upon exposure to a changing magnetic123 field.
• Thermoelectric materials are used to build devices that convert temperature differences into electricity and the reverse. In another embodiment thecondom127 that covers thepenis64 can include be impregnated40 with or lies withinreservoirs41 which contain a substance that can include a solid, liquid or gel or gas that can exhibit self healing125 characteristics. In another embodiment a substance can be released from the condom or sealingpad2 that can include a contraceptive substances which when exposed to a change in its environment to include its pH which differs in vaginal fluid compared to seminal fluid. In the preferred embodiment thecondom127 which covers thepenis64 contains materials that can alter theirphysical properties124 and can alter the materialsphysical characteristics124 to at least partially repair or seal125 abreech124. Other embodiments include theskin covering material3 orsealing pad2 oranchor device35 orfixation method11 alteringphysical characteristics124 to alter sensory and material sensations or properties to include changing temperature, physical contours and producing electrical stimulation in response to internal or external stimuli.
• FIG. 55 is a sagital depiction of anexoskeleton128 that can be composed a material to include a gel or solid that has the ability to alter itsphysical properties124 to include its hardness andsoftness94, itsthickness95 or length or width, its coefficient of friction, or its repair capabilities, or any combination of theseproperties124. In one embodiment the sealing pad2, fixation device11, anchoring device35 and skin covering material3 the indicators54 or feedback device42 or any combination of these elements can incorporate and exoskeleton128 that can be composed a material to include a gel or solid or liquid or gas that has the ability to alter its hardness or softness94 or thickness95 or any combination of these properties124 using a method or device to include a heating or cooling122 unit, or a reservoir41, or can have impregnated materials that can be a solid or liquid or gel or gas and can be formed from a material to include an elastomer to include a thermoplastic elastomer, gel, rubber, latex, and metals polymer and alloy materials to include temperature-responsive polymers which are materials which undergo changes upon temperature changes, smart metals to include Nitenol and shape memory alloys and non-metal shape memory polymers in which large deformation can be induced and recovered through temperature changes or stress changes and martensitic phase changes, piezoelectric materials that produce a voltage when forces or stress are applied resulting in structure altering shape to include bend, expand or contract when said voltage is applied, shape memory alloys and shape memory polymers which can have large deformations which can be induced and recovered through temperature changes or stress changes (pseudoelasticity), magnetostrictive materials which can change in shape under the influence of a magnetic123 field and can exhibit a change in their magnetization under the influence of mechanical stress, magnetic123 shape memory alloys which are materials that change their shape in response to a significant change in a magnetic123 field, pH-sensitive polymers which are materials that change in volume and shape when the pH of the surrounding environment changes, halochromic materials which can change their color as a result of changing acidity which can also be used as indicators to include condoms which can include a sensor to detect a breech in the condom integrity or intubation devices to include a sensor to detect whether gastric reflux or aspiration has occurred or wound covers that can include detect infectious agents that change the pH of the wound to include bacteria, fungi, viruses and other infectious pathogens, chromogenic systems which can change color in response to electrical, optical or thermal122 changes which can include electrochromic materials, which change their color or opacity on the application of a voltage to include liquid crystal displays, thermochromic materials change in color depending on their temperature, and photochromic materials, which change color in response to light, ferrofluids, photomechanical materials change shape under exposure to light.
• Self-healing materials have the intrinsic ability to repair damage due to normal usage, thus expanding the material's lifetime, dielectric elastomers (DEs) are smart material systems which produce large strains under the influence of an external electric field, magnetocaloric materials are compounds that undergo a reversible change in temperature upon exposure to a changing magnetic123 field. Thermoelectric materials are used to build devices that convert temperature differences into electricity and the reverse or other electromagnetic123 sensitive materials that can alter theirphysical properties124 when exposed to electromagnetic123 energy including ultraviolet and infrared sources or kinetic energy including vibration or chemical reactions including chemical bonding methods; and nonotechnology. In the preferred embodiment theexoskeleton128 can be incorporated with an intubation device is composed of agel sealing pad2 and a skin covering3 in which thegel sealing pad2 or thegel sealing pad2 andskin covering material3 incorporate anexoskeleton128 for altering theirphysical properties124 to include altering the hardness andsoftness94 andthickness95 or coefficient of friction of thesealing pad2 orskin covering material3 in response to the compression or pressure or the airtight and watertight seal required produced on or upon the local mucosal tissue andorifice lining skin1. Theexoskeleton128 can be composed of a thermoplastic polymer, a magneto-sensitive material, or an electromagnetic123 sensitive material that can include a gel.
• Indicators54 andfeedback42 devices can be positioned on or in or near or distant to theexoskeleton128 or sealingpad2 orskin covering material3 orfixation device11 or theanchoring device35 or any combination of these elements. In the presence of a physiologic or biologic stimulus or event that can include gastric reflux, aspiration, a decreased airtight or watertight seal, adverse pressure on thelocal mucosa1 or skin of theinternal cavity1 or theexternal skin1 or adverse positioning or pressure on the larynx, the indicator or measuringdevice54 can feedback a need to alter the physical property of theexoskeleton128 or thesealing pad2 in the preferred embodiment but can include theexoskeleton128, sealingpad2,fixation device11, anchoringdevice35 andskin covering material3 or any combination of these elements. In one embodiment afeedback device mechanism42 can be present but does not have to be present and which can automatically produce or initiate and can also turn off or vary or modulate a stimulus that can include a thermal122 device, an electromagnetic123 device, or a chemical device or any combination of these elements. In the preferred embodiment theexoskeleton128 can include a heating or magnetic123 unit that can be can be positioned on or in or just near the surface of thesealing pad2 but can include thesealing pad2, skin covering3,fixation device11, anchoringdevice35, theindicators54 orfeedback device42 or any combination of these elements such that thesealing pad2 which can include a thermosensitive metal, polymer, plastic. gel, or thermoplastic elastomer that can have itsphysical properties124 altered which can include influencing thegel sealing pad2 which is within the oral or pharyngeal cavity can have itsphysical properties124 altered which can include thegel sealing pad2 becoming more or less slippery, softer or harder or thicker or thinner or longer or shortened in response to the physiology or biology needs of the user. The alteration of the physical characteristics can be manually controlled by the user upon whom thesealing pad2 is being employed or the non-user upon whom thesealing pad2 is not being employed or any combination or numbers of users and non-users.
• Zero or one ormore endoskeleton129 orexoskeletons128 can be used with thesealing pad2,skin covering material3,fixation device11, anchoringdevice35 and theindicators54 orfeedback device42 or any combination of these elements. Theexoskeleton128 can include integrating atemperature altering device122 or anelectromagnetic device123 or a chemical reaction to altering the characteristics of theexoskeleton128. These devices can be controlled or modulated locally by thesensors54 andfeedback42 devices or by an external source or external controlling individual.
• FIG. 56 is a sagital depiction of anendoskeleton129 that can be composed a material to include a gel or solid that has the ability to alter its physical properties to include its hardness andsoftness94, itsthickness95 or length or width, its coefficient of friction, or its repair capabilities, or any combination of these properties. In one embodiment the sealing pad2, fixation device11, anchoring device35 and skin covering material3 the indicators54 or feedback device42 or any combination of these elements can incorporate an endoskeleton129 that can be composed a material to include a gel or solid or liquid or gas that has the ability to alter its hardness or softness94 or thickness95 or any combination of these properties using a method or device to include a heating or cooling122 unit, or a reservoir41, or can have impregnated materials that can be a solid or liquid or gel or gas and can be formed from a material to include an elastomer to include a thermoplastic elastomer, gel, rubber, latex, and metals polymer and alloy materials to include temperature-responsive polymers which are materials which undergo changes upon temperature changes, smart metals to include Nitenol and shape memory alloys and non-metal shape memory polymers in which large deformation can be induced and recovered through temperature changes or stress changes and martensitic phase changes, piezoelectric materials that produce a voltage when forces or stress are applied resulting in structure altering shape to include bend, expand or contract when said voltage is applied, shape memory alloys and shape memory polymers which can have large deformations which can be induced and recovered through temperature changes or stress changes (pseudoelasticity), magnetostrictive materials which can change in shape under the influence of a magnetic123 field and can exhibit a change in their magnetization under the influence of mechanical stress, magnetic123 shape memory alloys which are materials that change their shape in response to a significant change in a magnetic123 field, pH-sensitive polymers which are materials that change in volume and shape when the pH of the surrounding environment changes, halochromic materials which can change their color as a result of changing acidity which can also be used as indicators to include condoms which can include a sensor to detect a breech in the condom integrity or intubation devices to include a sensor to detect whether gastric reflux or aspiration has occurred or wound covers that can include detect infectious agents that change the pH of the wound to include bacteria, fungi, viruses and other infectious pathogens, chromogenic systems which can change color in response to electrical, optical or thermal122 changes which can include electrochromic materials, which change their color or opacity on the application of a voltage to include liquid crystal displays, thermochromic materials change in color depending on their temperature, and photochromic materials, which change color in response to light, ferrofluids, photomechanical materials change shape under exposure to light.
• Self-healing materials have the intrinsic ability to repair damage due to normal usage, thus expanding the material's lifetime, dielectric elastomers (DEs) are smart material systems which produce large strains under the influence of an external electric field, magnetocaloric materials are compounds that undergo a reversible change in temperature upon exposure to a changing magnetic123 field, Thermoelectric materials are used to build devices that convert temperature differences into electricity and the reverse or other electromagnetic123 sensitive materials that can alter their physical properties when exposed to electromagnetic123 energy including ultraviolet and infrared sources or kinetic energy including vibration or chemical reactions including chemical bonding methods; and nonotechnology. In the preferred embodiment theendoskeleton129 can be incorporated with an intubation device is composed of agel sealing pad2 and a skin covering3 in which thegel sealing pad2 or thegel sealing pad2 andskin covering material3 incorporate anendoskeleton129 for altering their physical properties to include altering the hardness andsoftness94 andthickness95 or coefficient of friction of thesealing pad2 orskin covering material3 in response to the compression or pressure or the airtight and watertight seal required produced on or upon the local mucosal tissue andorifice lining skin1. Theendoskeleton129 can be composed of a thermoplastic polymer, a magneto-sensitive material, or an electromagnetic123 sensitive material that can include a gel.
• Indicators54 andfeedback42 devices can be positioned on or in or near or distant to theendoskeleton129 or sealingpad2 orskin covering material3 orfixation device11 or theanchoring device35 or any combination of these elements. In the presence of a physiologic or biologic stimulus or event that can include gastric reflux, aspiration, a decreased airtight or watertight seal, adverse pressure on thelocal mucosa1 or skin of theinternal cavity1 or theexternal skin1 or adverse positioning or pressure on the larynx, the indicator or measuringdevice54 can feedback a need to alter the physical property of theendoskeleton129 or thesealing pad2 in the preferred embodiment but can include theendoskeleton129, sealingpad2,fixation device11, anchoringdevice35 andskin covering material3 or any combination of these elements. In one embodiment afeedback device mechanism42 can be present but does not have to be present and which can automatically produce or initiate and can also turn off or vary or modulate a stimulus that can include a thermal122 device, an electromagnetic123 device, or a chemical device or any combination of these elements. In the preferred embodiment theendoskeleton129 can include a heating or magnetic123 unit that can be can be positioned on or in or just near the surface of thesealing pad2 but can include thesealing pad2, skin covering3,fixation device11, anchoringdevice35, theindicators54 orfeedback device42 or any combination of these elements such that thesealing pad2 which can include a thermosensitive metal, polymer, plastic. gel, or thermoplastic elastomer that can have its physical properties altered which can include influencing thegel sealing pad2 which is within the oral or pharyngeal cavity can have its physical properties altered which can include thegel sealing pad2 becoming more or less slippery, softer or harder or thicker or thinner or longer or shortened in response to the physiology or biology needs of the user. The alteration of the physical characteristics can be manually controlled by the user upon whom thesealing pad2 is being employed or the non-user upon whom thesealing pad2 is not being employed or any combination or numbers of users and non-users. Zero or one ormore endoskeleton129 orexoskeletons128 can be used with thesealing pad2,skin covering material3,fixation device11, anchoringdevice35 and theindicators54 orfeedback device42 or any combination of these elements.
• FIG. 57 is a cooling orheating device23 that has one or more than one compartment that in the preferred embodiment is a head cooling or heating device134 that in this depiction contains more than one compartment.FIG. 58 is a cooling or heating device134 that has one or more than one compartment and in this depiction contains one compartment. One embodiment can include a cooling device134 that can be worn over the head or other body parts which in the preferred embodiment is worn over the head and neck region whose use is to treatbody8 to includebrain130 or biologic or physiologic conditions that can include overheating during warm weather, heat stroke, febrile seizures, muscle cramping, hair loss, heart disease and respiratory disease and renal diseases; and psychiatric disorders to include anger or rage or anxiety, suicide, depression, schizophrenia, memory and mania and other biological and psychiatric conditions thought to be caused or felt to be caused or exacerbated by excess body orbrain130 heating, conditions that would benefit from body orbrain130 cooling or slow body orbrain130 metabolism to include ischemic stroke, seizures,brain130 tumor growth. In one embodiment the cooling device can be composed of asealing pad2,skin covering material3,fixation device11, anchoringdevice35 andindicators54 orfeedback device42 or any combination of these elements. Incorporated into this device is a cooling device that can include a solid of liquid or gas or gel material that can be used to interface with thesealing pad2 which can be airtight and water tight but does not have to be airtight or watertight.
• Methods of cooling can include conduction which can include direct transfer of heat through cooling devices to include cooling tubes conduits orchannels16 that can contain water, Freon, chemical reactions,thermoelectric cooling122, or vapor compression cooling; or convection which can include fans, blowers impellers, and evaporation which can include refrigeration and fan and air-conditioning like devices. In one embodiment the cooling head cap is composed of asealing pad2 that can include a gel or a non-gel that can form an airtight or watertight seal with at least a portion of the user's head or neck to form an isolation chamber. In the preferred embodiment the seal is agel seal2. In method A the isolation chamber is created such that there can be a liquid or gel or a gas or solid or combination of these elements that passes between the user'sskin1 which can include thescalp131, face or neck and torso and serves as a means of removing heat or transferring heat away from the user'sbrain130. In one embodiments some orifices or some givenbody parts8 can be kept separate from the isolation chamber and these body parts can include a body that can include the user's mouth and nose and ears or torso such that thesebody parts8 can be sequestered from the remainder of the isolation chamber byadditional sealing pads2 or isolation chambers.
• There can be zero or one or more than one isolation chamber used for the head cooling device. There can be one or more than one isolating chambers that affect and effect cooling. In another embodiment sealing pads or 2 isolation chambers can be used to isolatebody parts8 that containssensors54 orfeedback devices42 or surgical areas of intervention and in which the material that can include solids, liquids and gels and gases between the user's skin and the cooling device is isolated and sequestered from the actual cooling portion of the head cooling device. In Method B another embodiment thegel sealing pad2 can contain methods or transferring heat away from the body that can include conduction, convection or evaporation. Method A and Method B can be used alone or in combination.Sensors54 andfeedback42 units can be used to monitor and feedback control of physiologic and biologic functions to regulate core body andbrain130 temperature. The theory behind this invention is that there are somebrain130 functions to include febrile seizure and ischemic stroke that can benefit by reducing oxygen and metabolic requirements of thebrain130 more than other body parts. In another embodiment warming and cooling devices can be used together.
• In another embodiment the head warming device that can be worn over the head whose use is to treat the body orbody parts8 to includebrain130 or biologic or physiologic conditions that can include overheating during cold weather, hypothermia, hair loss, and psychiatric disorders to include depression, memory and other biological and psychiatric conditions thought to be caused or felt to be caused or exacerbated by excessive body orbrain130 cooling, conditions that would benefit from body orbrain130 heating or more rapid body orbrain130 metabolism to include warming from hypothermia,brain130 tumor growth to include during chemotherapy. In one embodiment the heating device can be composed of asealing pad2,skin covering material3,fixation device11, anchoringdevice35 andindicators54 orfeedback device42 or any combination of these elements. Incorporated into this device is a heating device that can include a solid of liquid or gas or gel material that can be used to interface with thesealing pad2 which can be airtight and water tight but does not have to be airtight or watertight. Methods of warming can include conduction which can include direct transfer of heat through heating devices to include heating tubes conduits orchannels16 that can contain water, thermoelectric heating, or radiator-like warming devices; radiant or radiation heat or electromagnetic123 or chemical or kinetic or Brownian heating or convection which can include heated substances through fans, blowers. Conduits and channels ortubes16 can be used in either compartment orchamber132,133 to carry materials to include solid, liquid, gels and gases. In one embodiment the heating head cap is composed of asealing pad2 that can include a gel or a non-gel that can form an airtight or watertight seal with at least a portion of the user's head or neck to form an isolation chamber. In the preferred embodiment the seal is agel seal2.
• In method A the isolation chamber is created such that there can be a liquid or gel or a gas or solid or combination of these elements that passes between the user'sskin1 which can include thescalp131, face or neck and torso and serves as a means of adding heat or transferring heat toward the user'sbrain130. In one embodiments some orifices or some givenbody parts8 can be kept separate from the isolation chamber and these body parts can include a body that can include the user's mouth and nose and ears or torso such that thesebody parts8 can be sequestered from the remainder of the isolation chamber byadditional sealing pads2 or isolation chambers. There can be zero or one or more than one isolation chamber used for the head warming device. There can be one or more than one isolating chambers that affect and effect cooling. In anotherembodiment sealing pads2 or isolation chambers can be used to isolatebody parts8 that containssensors54 orfeedback devices42 or surgical areas of intervention and in which the material that can include solids, liquids and gels and gases between the user's skin and the cooling device is isolated and sequestered from the actual cooling portion of the head cooling device. In Method B another embodiment the gel sealing pad can contain methods or transferring heat toward the body that can include conduction, convection or radiation, radiant heat. Method A and Method B can be used alone or in combination.
• Sensors54 andfeedback42 units can be used to monitor and feedback control of physiologic and biologic functions to regulate core body andbrain130 temperature. The theory behind the cooling invention is that there are somebrain130 functions to include febrile seizure and ischemic stroke that can benefit by reducing oxygen and metabolic requirements of thebrain130 more than other body parts. The theory behind the warming invention is that there are somebrain130 functions to include hypothermia, depression and tumor sensitivity during chemotherapy that can benefit by increasing oxygen and metabolic requirements of thebrain130 more than other body parts. Heating and cooling of thebrain130 may have changing benefits depending on tissue andbrain130 sensitivity during treatments to include tumor treatment and psychiatric conditions.
• The heating and cooling body part devices can be utilized on just the head or on the head and neck region for greatest effect on thebrain130 and body but these devices are not isolated to the head and neck and can be used onother body parts8 to include the torso, appendages and internal organs using thesealing pad2,skin covering material3,fixation device11, anchoringdevice35 andindicators54 orfeedback device42 or any combination of these elements described herein. These heating and cooling devices can be used to include treatment for treat peripheral vascular disease, Raynaud's disease, diabetes, and neuropathies and can be used to treat and provide symptom relief for sensory discomfort. These devices can be used for providing pleasure and can be used on appendages to include the penile and vaginal and anal regions for sexual pleasure and to improve sexual function to include erectile function, orgasm, and sexual pleasure and stimulation and can be combined with other devices to include vibration and ultrasonic devices and substances that can invoke sensory responses. These devices can be used for relieving pain and discomfort and can be used on appendages to include the arms and legs and anal regions and can be combined with other devices to include vibration and ultrasonic devices and substances that can invoke sensory responses. The heating and cooling device can utilize and include the use of radiant or electromagnetic123, kinetic or Brownian, or chemical energy or any combination of these energies to achieve the desired outcome.
• An external device can be used to supplement treatment and effect the head cap for heating or cooling. Inner132 and outer chambers133 can be zero, one or more than one and the channel or conduit dominated versus the non conduit or channel dominated forms of healing can be varied and interchanged relative to their positions on the head and relative to their positions on theskin1 to include specific parts of thebrain130 can be heated or cooled more than other parts. These similar variations can be used with other parts of the body in addition to thebrain130 andscalp131. The heating or cooling units can include askin covering3, sealingpad2 orfixation device11 or anchoringdevice35 or any combination of these elements which in one of the preferred embodiments can include a single compartment model that is a gel sealing pad which containsfeedback devices42,indicator devices54, and heating and cooling devices and energy delivery devices which are external59 or internal to thesealing pad2.
• FIG. 59 is a sagital depiction of acast138 that has agel undercoat136 orgel roll135 between thecast138 and the user'sskin1. In one embodiment a gel can lie between thecast138, which can include and can be composed of fiberglass, polymers, plastics, metals and metal alloys,microfibers140, and plaster and clay or earthen materials. Traditionally a cloth or cotton material is interpositioned between thecast138 and the skin to absorb moisture and prevent abrasion of theskin1. In one embodiment the material between the skin and thecast138 can be a gel that provides properties to include osmosis, air circulation, and the ability to wick water away from the skin or any combination of these properties. In one embodiment to accomplish osmosis, breathability or ability to wick or any combination of these properties the gel can include the gel being ultra-thin, containing pores or holes, being designed as a weave which can include an open weave, being combined with a fabric that can assist in the needed properties that can include natural fibers to include cotton or synthetic fibers that can emulate cotton to include or a fabric to include Cupro; ormicrofibers140 or combination of these materials. In another embodiment the material, which can be used as the lining material interposed between thecast138 and the skin can include or a fabric to include cotton, Cupro ormicrofibers140 or combination of these materials. In another embodiment a gel can be interposed between or afabric140 to include the Cupro ormicrofiber140 or cotton layer or combination of these materials and thecast138. In another embodiment a gel can be interposed between or afabric140 to include Cupro ormicrofiber140 or cotton or combination of these materials and the skin. In another embodiment the gel can be woven with or a fabric to include cotton or Cupro ormicrofiber140 or combination of these materials. In another embodiment the interposed material can be bound to thecast138 and can include a gel or afabric140 to include cotton or Cupro or microfiber or to a combination of these materials and the purpose of this is to create a morewaterproof cast138 that is breathable and less abrasive and wick water more effectively. For initially placing the case onto the skin anresorbable material139 can be but does not need to be used and the absorbable material can include fabric-like140 materials that can include resorbable139 materials that can include rice paper, resorbable139 scaffolds including nontechnology to includeElectrospun Fabrics140, Salt-Leaching Porous Films, resorbable polymers including polylactide acid and polyglycolides or combinations of these materials. In the preferred embodiment thecast138 can be made of a water-proof material that can include fiberglass that containsair gaps137 for breathability and has an undercoating ofgel136 integrated in the cast or a layer of gel roll-like material lining135 or process as a lining between thecast material138 and theskin1. In one embodiment the gel lining can be continuous or discontinuous. In another embodiment thecast material138 can include being constructed as a weave or mesh or lattice or fence-like configuration such thatair137 resides between the castingmaterial138. To create this lattice in one embodiment thecast material138 can be composed of aresporbable material139 that lies in the locations where theair137 gaps will ultimately reside. Once the castingmaterial138 is placed onto the body part theresorbable material139 can be resorbed by methods to include resorption by water, a chemical reaction, an energetic reaction to include electromagnetic, chemical and kinetic and Brownian energy. In the preferred embodiment the resorbedmaterial139 can be a lactate or rice like material that can be used with afiberglass cast138 with a continuous ordiscontinuous gel lining135,136 that when exposed to water, theresorbable material139 resorbs away or melts or dissolves away, leaving the fiberglass cast138 present andairholes137 present between thecast material138. This can be performed so the airspaces are vertical or horizontal or a combination of vertical and horizontal relative to thebody part8. Fabric used can include manmade and natural fabric and fibers. Resorbable materials can include manmade and natural fabric and fibers that can include protein, sugar and carbohydrates, fats and any combination of these molecules which can be at least partially resorbed. In another embodiment the cast material can be composed of manmade and natural fabric and fibers that can include protein, sugar and carbohydrates, fats and any combination of these molecules which can be at least partially not resorbed.
• FIG. 60 is a sagital depiction of askin covering material3 which can include being used as a contraceptive or condom or condom-like or infection prevention device that can be used by both a male or female condom. In one embodiment the condom, condom-like device, the contraceptive or the infection-prevention device can include askin covering material3 which can include including askin covering material3, asealing pad2, afixation method11 or ananchoring device35 or any combination of these elements that can be being able to be repaired at least partially or fully by a method to include patching, plugging, annealing, neutralizing or closing the breech in the condom orskin covering material3 function. The breech can include a hole, a tear, a rent or a leak. In the preferred embodiment the condom device can include having a substance or substances that can be a solid a liquid, a gel or a gas which can reside in a location in association with the condom to include residing freely in, coating, loosely bonding, tightly bonding, lining, or impregnating40 the condom including askin covering3, sealingpad2 orfixation device11 or anchoringdevice35 or any combination of these elements. The substance can be located on the inside of or on the outside of or within or integrated into the condom orskin covering material3, or sealingpad2 orfixation device11 or theanchor device35 or can be any combination of these locations. In another embodiment the condom can containreservoirs41 within the condom. In the preferred embodiment the condom can patch the breech or leak by the condom containing a substance that can the substance altering its physical properties and state which can include the substance changing its state from a liquid or gel into a denser gel or a solid state.
• The stimulus for the state change can include a condition or trigger that includes a change in pH, a change in the concentration of fructose, a change in the concentration of sperm, or other changes in the chemical or electromagnetic or kinetic or Brownian energy of the environment or field. In one embodiment the substance can include a liquid or semi-gel that is triggered by an alkaline environment to become a dense gel or a semi-solid material. In this embodiment when the substance, which lies between the condom and the users' skin or is bonded or impregnated into the condom, is exposed to semen or seminal fluid which has an alkaline pH liquid substance, which lies between the condom and the users' skin or is bonded or impregnated into the condom, undergoes a state and transforms from a liquid to a gel. Other embodiments can include the substance residing at the base of the condom such that if semen leaks along or outside of the base or opening of the condom near the user's torso then the substance will be activated. In this embodiment if the semen or seminal fluid can insinuate themselves between thesealing pad2 or the skin covering3 of the male condom and the user's skin then the substance will be activated to transition from a liquid to a gel. In this embodiment the state altering substance can reside or be associated with residing or being associated with thesealing pad2 or skin covering3 or a combination of these elements. When the semen or seminal fluid leaks from the base and comes in contact with the state altering substance then the liquid transforms into a gel and swells to obstruct the leaking region of the base sealing the condom and preventing any additional emission of semen out of the condom. The condom can have a state altering substance.
• In another embodiment if the condom or skin cover develops a leak or hole or breech then the state altering substance will seal after ejaculation when the seamen and seminal fluid is released and comes in contact with the state altering substance. In another embodiment a female condom can contain the state altering substance between the user and the condom which can include containing a skin covering3 orsealing pad2 orfixation device11 or anchoringdevice35 or any combination of these elements. If semen or seminal fluid leak between the user's skin and the condom then the condom develops a leak or hole or breech then the state altering substance will seal after ejaculation when the seamen and seminal fluid is released and comes in contact with the state altering substance which can be located be located between the user's skin and condom, within the condom or outside of the user's skin and condom and any combination of these locations. Other embodiments of the condom can include the state altering substance residing in multiple locations relative to the user and the condom and relative to the portions of the condom and relative to the components of the condom.
• Embodiments can include condom which can assist with contraception and disease or infection prevention not by altering its physical property of the condom or serving as a chemical patch if a condom or condom like device develops leaks or breaks or has a breech. Other embodiments can include the leak in the condom may at least partially persist but the effects of the leak are reduces or are neutralized or treated when the state altering substance intermingles with either semen or seminal fluid or vaginal fluid or bodily fluids or any combination of these fluids. In another embodiment to assist with contraception other medications or substances can be utilized with the condom that can include a solid, a liquid, a gel or a gas that can be used for contraception or disease or infection prevention. In one embodiment a condom can contain or be impregnated with40 or be lined with or containsreservoirs41 that can have a contraceptive that can include Contraceptol™, contraceptive jelly, Maraviroc, sold under the brand names of Selzentry and Celsentri, a new class of HIV drugs called CCR5 blockers, which prevents the virus from getting into the cells it infects. In another embodiment, the condom can contain an indicator as discussed inFIG. 31, which can be composed of halochromic materials which can change their color as a result of changing acidity or electrochromic materials that can change with changes in electrical charges. In another embodiment at least a portion of the condom can be composed of an indicator-like material that can change color to include to halochromic materials which can change their color as a result of changing acidity or electrochromic materials that can change with changes in electrical charges. In one embodiment these materials can be located on the inside or outside or within the condom or skin covering. One embodiment can include a male condom where the indicator material or indicator can be located on the inside of the condom and the indicator is sensitive to an acid. Since semen are alkaline if there is no leakage the condom will not change its indicator or condom which is composed at least partially of an indicator then the reference state that can include color or other sensory stimuli to include visual cue, shape, or contour or temperature, will not change its normal reference. In the preferred embodiment if the acid, or fructose or other uniquely vaginal biological substances of the vaginal and female space enters the inner space between the condom and the male user's skin then the indicator on the inside of the condom will change its reference signal which in the preferred embodiment means the indicator or condom will change color or contour indicating a leak or breech in the condom.
• Other embodiments can include indicating leakage of male unique biological material into the female space to include semen and seminal fluid. Other embodiments can include the use of self sealing materials which can form at least a portion of the condom or skin covering material or sealing pad as described inFIG. 54 and can be utilized be used in combination with state altering substances. Other applications for self sealing bags can be used in biological applications to include urinary, ostomy, fecal, blood or other bodily materials or self sealing seals or skin covering materials can include goggles and other applications described herein.
• FIG. 61 is a frontal view of an occlusive device that utilizes a substance that can undergo astate change141 and can be used in a living organism to include but not restricted to a the female reproductive system to occlude thefallopian tubes143. Other embodiments can include but are not restricted to the male reproductive system to occlude but not restricted to the male spermatic tubes. Seminiferous tubules, and testicular structures; a vascular structure to include but not restricted to an artery, vein, vascular malformation to include but not restricted to a laceration57 or tear or rupture of avessel60, a hemangioma, a venous AVM; an aneurysm, an arterial or venous or mixed arterial and venous malformation or a varix; an outpouching or a ganglion of a joint; a burn or wound, a bone defect to include but not restricted to a fracture in the temporal bone or in the cribiform plate; a finger nail or toe nail; an ear structure to include but not restricted to a tympanic membrane, or a nasal structure to include but not restricted to a nasal septum. Currently, tubal ligation of thefallopian tube143 can be performed by legating or clipping thefallopian tube143 or by catheterizing thefallopian tube143, which is invasive and requires surgery or placing a device into thefallopian tube143 which is often unsuccessful because of the difficulty that doctors have in cannulating147 deeply into bothfallopian tubes143. One of the methods for visualizing thefallopian tube143 is performing a hystero-salpingogram, which is a method by which a catheter is place into theuterus142 and at thejunction162 of theuterus142 and thefallopian tube143 there is an entry or opening163 or ostium or os, where thefallopian tube143 begins. Acatheter147 is then placed at thefallopian tube143entry163 oros163 and then contrast is injected. The contrast enters thefallopian tube143 and visualized the inner tube-like portion of thefallopian tube143. Injecting a material into thefallopian tube143 is simpler than placing awire149 or introducer or catheter guide, which is simpler than placing a tube or catheter orcannula147, and all three are simpler than placing a device into thefallopian tube143, which is the current method of non-invasive tubal occlusion.
• The preferred embodiment can include but is not restricted to placing acatheter147 at theopening163 of thefallopian tube143 at the uterine andfallopian tube143junction162. In the preferred embodiment zero, or one ormore string149 or wire-like149 introducer can be introduced into thefallopian tube143 to include but not restricted to a fiberoptic cable, a metal, a memory metal, a thermal reactive material, electromagnetic-reactive material, pH sensitive material, chemical sensitive material or other biocompatible material to include but not restricted to a fibers including but not restricted to microfibers, man-made fibers or natural fibers, resins, polymers or plastic can be introduced into thefallopian tube143 and can serve as but are not restricted to ascaffold144 that can include a resorbable or nonresorbable scaffold144 or extrusion or removal or stimulating device to include but not a thermal reactive, electromagnetic-reactive, pH reactive, or chemical reactive device. One embodiment can include semi permanent occlusion and include but are not restricted to cements145 and materials that can be reversed when exposed to the proper adjuvant t which can a include but is not restricted to chemical solvents, pH, or energies to include but not restricted to chemical, electromagnetic and kinetic or Brownian energy. One embodiment can include but is not restricted to having a bulbousdistal portion148 that can but is not restricted to occlude the distalfallopian tube143 to prevent egress of materials out of the tube. One embodiment can include but is not restricted to the bulbous148 component being a permanent structure to include a flange-like device or a spring like structure that can at least partially occlude the tube, or areservoir41 that can be inflated and deflated that can be filled with a solid, a liquid, a gel or a gas. The string or wire-like structure that fits inside of thefallopian tube143 can include but is not restricted to a wire- or string like device that can hang into theuterus142 for removal of thefallopian tube143 occlusive agent.
• The wire or optical cable or device can utilize a electromagnetic energy or kinetic or Brownian energy to include but not restricted to heat or cold or a chemical reaction to alter the state of thesubstance141 to include but not restricted to the liquid changing to a gel or solid or the gel changing to a solid or the reverse process to include but not restricted to where a solid or harder gel becomes a gel or a liquid.
• Currently, materials are available that undergostate changes141 to include but not restricted from metamorphosize from a liquid to a gel or solid or a gel to a solid. Methods for creating this transformation include but are not restricted to altering the pH as occurs with a liquid contraceptive where the liquid is placed into the vagina which has a acidic pH of 3.8 to 4.5 and when in contact with semen which are alkaline with a pH of 7.2 to 7.8; or materials that alter from liquid-gels and become solid such as dental crowns which are made of biocompatible materials and cements145 that are UV or heat fixing or tooth coating and sealant treatments which are plastics resins which when exposed to electromagnetic or kinetic energy alter to a solid form or hydrogels that can be formed to include but not restricted to being formed by injecting the hydrogel or can be formed and fixed by mixing one or more materials which when in contact change state such as but not restricted to hydrophilic polymers, incorporating chitosan derivatives complexed with polyvinylpyrrolidone (PVP). Once the catheter is placed into the opening of thefallopian tube143 an occlusive agent can be placed or injected into thefallopian tube143 that can include but is not restricted to a state changing material that can include but is not restricted to a material that changes state using a chemical reaction such as a pH change, a themoplastic and sensitive material, an electromagnetic plastic and sensitive material, hydrogel and other mixed chemical components and resins or a biological sensitive material. In another embodiment more permanent materials can be injected to include but not restricted to silicon, UV sensitivedental cement145 and sealants, glues to include but not restricted to cyanoacrylate and other acrylic resins, which rapidly polymerize.
• One of the limitations of current non-invasivefallopian tube143 occlusion methods is the inability to fully catheterize the fallopian tube143s. Methods for improved catheterization can include but are not restricted to the use of muscle relaxing a and paralyzing agents to be used at a site to include but not restricted to the entry of thefallopian tube143, in theuterus142 and in thefallopian tube143 and substances to perform this function can include but are not restricted to solids, liquids, gel or gases that can be effective, topically, injected or introduced into the tissue or local blood flow or delivered in other biological methods to include but not restricted to combined delivery or activation of at least one or more substances or forms of energy to include but not restricted to kinetic or electromagnetic or chemical energy or reactions. One embodiment can include chemicals to relax or reduce spasm at the opening of thefallopian tubes143 to include but not restricted to Botx or Botox-like orderivative chemicals146, curare and Curari-like substances146, paralytic-type agents146 to include but not restricted to neuromuscular blockers that include but are not restricted to competitive nondepolaring agents that compete for acetylcholine that include but are not restricted to curarizing agents that resemble curare alkaloids that include but are not restricted to pancuronium, atracurium; neuromuscular blocking agents to include but not restricted to gallamine, vercuronium, metocurine; noncompetitive nondepolaring agents to include but not restricted to succinylcholine; spasmolytics and sarcoplasmic reticulim agents to include but not restricted to methocarbamol, guaifenesin, diazepam, dantrolene and other nerologic and muscle and neuro-muscular relaxing. In another embodiment ascaffold144 or triggering agent can be instilled into thefallopian tube143 or the wire-like device can be but not restricted to being composed of coated with, or can be an introducer of a material to include but is not restricted to a catheter that can have but not restricted to endholes152 and side hole or can be coated with or composed of reactive substances with the state altering substance or can introduce the state altering substance. In another embodiment ascaffold144 can be introduced that can be but is not restricted to a primary state altering substance or a secondary substance or deliver a secondary substance or energy source that can alter its state when in contact with the state altering substance. Thescaffold144 can include but is not restricted to a carbohydrate orcellulose scaffold144, a protein or a fat or a mineral or ascaffold144 that can be a combination of substances and can but is not restricted to react with an energy source or another substance. In one embodiment thestate altering material141 that fills thefallopian tubes143 can extend into the uterine142 cavity and can be shaped by a direct method of visualization with fiber optics near thejunction162 andostium163 of the uterine142 andfallopian tube143.
• In another embodiment as a primary means of occluding thefallopian tube143 or a secondary means of occluding thefallopian tube143 to include but not restricted to if the opening or thefallopian tube143 cannot be cannulated then the state altering material, thescaffold144 or a combination of one or more of these substances andscaffolds144 can be injected or placed at the entry andjunction162 of theuterus142 and thefallopian tube143 to block thefallopian tube143 opening. Other more permanent agents can also be used to block thejunction162 of theuterus142 and thefallopian tube143 to block thefallopian tube143 opening to include but not restricted to cements145,glues145 sclerosants145 andsealants145. In one embodiment the fallopian tube and the opening and junction of the uterus and the fallopian tube can be blocked together with a combination of a fallopian tube material that is continuous with a cap like covering of the fallopian tube opening and the uterine and fallopian tube junction.
• FIG. 62 is a frontal view of a cap150-like device150 and method to occlude the female reproductive system at theopening163 of theuterus142 and thefallopian tubes143 and a method to the keep in place ascaffold144 or thestate altering substances141 or asealing pad2 or a more permanent agent or acement145 orsclerosing agent145, or a device can be held in place to include but is not restricted tosewing158, hooking158 or grappling158 or stapling158 or pinning158 thescaffold144 or cap150-like device150. The device that is referred to herein as acap150 that can include a shape that can include but is not restricted to a shape that is formed or emulates and molds to the shape of the uterinefallopian tube143junction162, a rounded shape, or a shape or device that resiliently or non-resiliently deforms to the shape of theuterus142 at and near thefallopian tube143 anduterine junction162. One embodiment can include a shape that is created by performing and imaging scan that can include but is not restricted to a CT scan, MRI scan, or Ultrasound 3-d scan that can reproduce the shape of the uterine andfallopian tube143junction162 and can be produced for each individual to form fit that specific individual. In another embodiment a general shape can be used that can be specifically be molded to the specific individual during the placement of saidcap150. Thecap150 can be composed of a material or a combination of materials to include but not restricted to man-made or natural materials to include but not restricted to metals, plastics, polymers, silicon, resins, gelatinous elastomers, shape memory materials, thermoplastic and electorplastic shape altering materials, state changing materials,scaffolds144, fabrics, wood products, microfibers, and other solids, liquids and gases and gels or combinations thereof. In another embodiment saidcap150 can be ageneral scaffold144, which can serve as a general endoskeleton or exoskeleton upon which or into which the occlussal or occluding substance placed. In the preferred embodiment the occlussal or occluding substance can include but is not restricted to a state altering material or a more permanent material or occluding agent. The occlussal or occluding substance can be used in combination with thescaffold144, the cap150-like device in combination or separately or any combination of these. In another embodiment the occlussal or occluding substance can be used in combination with thescaffold144, the cap150-like device in combination or separately or any combination of these can be used with a surgery that can include performing a procedure that can include one or more surgical flaps or redundant folds that can hold the occlussal or occluding substance, thescaffold144, the cap150-like device or any combination of these in place. The devices and substances describes herein can include but is not restricted to being radio-opaque so as to be visible by electromagnetic X-ray or non-ferromagnetic material to include but not be restricted to be able to be used in an MRI scanner.
• In the preferred embodiment the cap-like163 device will be molded to fit each individual using a planning CT or MRI or Ultrasound scanner. Thefallopian cap150 device will be composed at least in part of a resilientgel sealing pad2 that will be of variable elasticity so that it can be anchored into the myometrium with sutures or staples or grapplingdevices158. IN one embodiment astate altering material141 or a cement or occlusive material can be placed distal to thecap150 in thefallopian tube143. The cap will be placed at thejunction162 or theuterus142 and thefallopian tubes143 to block thefallopian tube143opening163. In a preferred embodiment thestate altering material141 can be use with anelastomeric cap150 ormatrix144. and can be integral or integrated or can be separate.
• In another embodiment these processes can be used in combination or in combination with current methods for invasive or non-invasive occlusion. In another embodiment these methods can be used to close other ostia or openings or tubes to include but not restricted to the seminal vesicles, seminiferous tubules, or the biologic sperm delivery components.
• FIG. 63 is sagital view of a vessel substitute or stent151-like device151 can be composed of ascaffold144 that can include ascaffold144 that can be non-resorbable or at least partially resorbable. The vessel substitute or stent151-like device can be used to treat but not restricted to be used to treat a situation where blood flow needs to be controlled over a segment of avessel60 to include but not restricted to a vascular laceration57 to include but not restricted to anartery60 or avein60. Thevessel60 substitute or stent151-like device can be composed of to include but not restricted to a solid a liquid or a gel or a gas which can include but not restricted to a carbohydrate or cellulose, a protein or amino acid, a fat, a mineral or a combination of these materials that when exposed to a second substance can be resorbed and can create but is not restricted to creating achannel16 or aconduit16. Thescaffold144 can include acatheter147 orwire149 that can be used to include but not restricted to include being used as an anchor, a delivery device that can include but is not restricted to a substance or energy to modulate thescaffold144 and can include but is not restricted to occluding or open achannel16. Thecatheter147 can include but is not restricted to containing avalve89 that can control the flow by wirelessly controlling thediameter157 of the catheter from external to include but not restricted tocompression27 of the catheter or internally to include but not restricted tovalves89. In one embodiment thescaffold144 orcatheter147 andwire149 or any combination of these can put in the location of the damagedvessel60. One embodiment can include the placement of a state altering substance into or onto thevessel60 substitute or stent151-like device. Thestate altering substance141 can vary in its solid, gel or liquid nature and can include the ability to regulate the channel that allows blood to flow159 through thevessel60 substitute or stent151-like device. Thevessel60 substitute or stent151-like device can include an external conduit that can connect to an inner lumen or channel orconduit16 such that theexternal conduit16 can deliver a substance to include but not restricted to a solid or liquid or gel or gas which in the preferred embodiment would deliver an oxygen carrying liquid. In another embodiment the placement of a state altering substance into or onto thevessel60 substitute or stent151-like device can create an external cast which can include but is not restricted to agel seal2 or astate altering substance141 orclot160 or a combination of these elements which can form around thevessel60 which can include but is not restricted to bonding, attaching or insinuating into the local tissue to tamponate the blood. Thisvessel60 substitute or stent151-like device can include being used with the cast and wound cover described within this patent.
• FIGS. 64 A and B are a sagital views of a multi-hole152,153catheter147 withside holes152 that can vary in size and shape that can be used to deliver substances in a differential fashion. In one embodiment the side holes152 are larger at the proximal155 end of thecatheter147 than at the distal end of thecatheter147. The side holes152 can include but are not restricted to a geometric and a non-geometric pattern. In the preferred embodiment the geometric pattern of the openings can include but are not restricted to circles or ellipses or slits153 or any combination of geometric patterns. In the non-geometric patterns the openings can include but are not restricted to random patterns that change are similar or variable in shape and size from proximal155 to distal.
• The rate of enlargement of the side holes152 can be based to include but not restricted to the length of portion of the tube or conduit or channel orcatheter147 where a substance that can include a solid or liquid or gas or solid is to be delivered; the delivery pressure within thecatheter147 and the external pressure surrounding thecatheter147. Thecatheter147 can be used to include but not restricted to use in an environment in which thecatheter147 is surrounded by a gel or semi-gel or semi-solid orsolid scaffold144 that can or needs to be dissolved. An environment in which thecatheter147 is encased or embedded in a gel or semi-gel or semi-solid or solid which can include but is not restricted to a thrombus or blood clot within ablood vessel60 or tube orcatheter147 or a man made occlusion of avessel60 or acatheter147 or tube to include but not restricted to a gel or semi-gel or semi-solid or solid.
• If a tube orcatheter147 resides in ablood vessel60 that is thrombosed or surrounded by a gel or semi-gel or semi-solid or solid then the fluid that enters saidcatheter147 with theend hole161 and the more distal side holes152 encased will experience a tendency to have the intra-luminal fluid exit or escape from the tube orcatheter147 more easily proximally155 than distally156 especially if all theholes152 are the same size. This tendency of the intra-luminal fluid to exit proximally155 will increase dramatically if not exponentially once the material encasing the proximal155holes152 begins to dissolve. In one embodiment to counter the tendency of intra-luminal fluid to exit from thecatheter147 proximally155 the proximal155side holes152 can be created to include but not restricted to the proximal155side holes152 being made smaller than the distal side holes152. Another embodiment can include but is not restricted to where the proximal155side holes152 can include a shape to include but not restricted to aslit153 where the resistance in theslits153 to the fluid exiting from the proximal155side slits153 of the tube orcatheter147 is greater than thedistal slits153 of the tube orcatheter147. Another embodiment can include but is not restricted to a material that can include but is not restricted to a material that covers or coats the tube orcatheter147 such that theholes152 orslits153 or exit points of thecatheter147 creates greater resistance in the more proximal155holes152 orslits153 or exit points. One embodiment can include but is not restricted toholes152 that are covered by an osmotic154 material that has greater resistance proximally155 than distally. In one embodiment this can include but is not restricted to the osmotic154 material being thicker proximal155 than distal. In another embodiment thecatheter147 can be made form a state altering material that has the side holes152 constrict in size or become closed or coated or covered by a material, once the flow through ahole152 increases. Since the proximal155side holes152 as a rule will experience greater flow sooner than thedistal holes152 then the proximal155 exit points will constrict or coat or close sooner than thedistal holes152 and thus the proximal155side holes152 will experience a greater pressure resistance than the distal side holes152 or theend hole161.
• Another embodiment can include but is not restricted to the inner lumen of the tube orcatheter147 being constructed such that the innerluminal diameter157 varies over the length of thecatheter147 especially at its distal aspect. In the preferred embodiment near the proximal155side hole152 than the distal side holes152 orend hole161. This will result in the intra-luminal fluid pooling more in thedistal catheter147 more than the proximal155catheter147 or tube. If the fluid is injected in a non-continuous manner than the distal side holes152 and the distal external encased material should experience a longer temporal exposure to the fluid injected into thecatheter147. Another embodiment can include the tube orcatheter147 having but is not restricted to any combination orvariable side hole152 size, shape, coating andosmotic barriers154 andintra-luminal diameter157.
• FIGS. 65A,65B, and65C are sagital views of a method for folding164 asealing pad2 to create an airtight and watertight seal with the user'sskin1 using a cast coveringskin covering material3. In the preferred embodiment of thecast cover3 is composed of a waterproofskin covering material3 and an annulargel sealing pad2 which is tacky and elastic can be formed so that when it is in its resting or relaxed state it is approximately the same circumference or very slightly less circumference than the user's appendage. Thegel sealing pad2 will have the ability to stretch to many times it's resting and will be resiliently deformable such that thesealing pad2 will return to its resting circumference. This will allow thesealing pad2 to easily fit over the appendage or a structure or device associated with the appendage to include but not restricted to a cast, a wound cover, a central intravenous or arterial catheter in a manner that the skin of the appendage or the structure or device associated with the appendage is not damaged. Thesealing pad2 can be placed over the distal aspect of the appendage, which for example may be the fingers of the hand and arm. One place comfortably over the distal aspect of the appendage thesealing pad2 can be positioned over the appendage and the structure or device, which can include but is not restricted to a cast, until thesealing pad2 are proximal to the cast and rest comfortably on the proximal skin with thesealing pad2 lying flat against the skin. Once thesealing pad2 is in place a waterproofskin covering material3 can be placed into position. If thesealing pad2 is to be used for a distal arm cast then there will be an open end of the waterproofskin covering material3 and a closed end. The open end will be place over the fingers first and positioned in a similar manner such that it rests in the middle aspect of flat sealing such that the distal half portion of thesealing pad2 is covered by the waterproofskin covering material3 while the proximal half portion of thesealing pad2 is not covered by the waterproof skin covering. Next the distal half portion of thesealing pad2 is folded164 over the proximal half portion. This creates asealing pad2 with a C shape such that the distal half of thesealing pad2 forms a watertight seal with the skin; the waterproofskin covering material3 is wedged between the proximal and distal halves of thesealing pad2 in a manner that thesealing pad2 forms a waterproof seal with theskin covering material3 on side of theskin covering material3 that is both interior and exterior or closest and farthest to the skin. The proximal half portion of thesealing pad2 is now external to the distal half portion and rests on the distal half of thesealing pad2 and creates agentle compression27 on the distal half of thesealing pad2 that is creating and airtight and watertight seal and thisgentle compression27 further assists with creating the airtight and watertight seal. In the preferred embodiment the open end of theskin covering material3 will be wider than the remainder of theskin covering material3 and will serve as a bulbous32 end portion that can serve as a male end or protuberance or bulbous32 insinuator. Thesealing pad2 can have a groove orfemale invagination31. When thesealing pad2 is folded164 over the skin covering's male bulbous32 end portion will insinuate itself into thefemale invagination31 or groove of thesealing pad2 and create a lock and key like mechanism for thesealing pad2 and theskin covering material3. Thesealing pad2 can include but is not restricted to being folded164 more than or less than in half. The locking mechanism can include but is not restricted to multiple shapes to include geometric shapes that are more or are less resistant to tugging or disengaging. The skin covering can have more than one opening especially when the skin covering is place such that it is important for the middle portion of the body part or appendage to be covered but a proximal and distal portion of the body part is to remain uncovered. One example of this can include a PIC line that is placed in the antecubital region near the elbow and the shoulders are uncovered and it is desirable to have the hands uncovered so that the hands can be without a covering to be used freely. Waterproof can mean airtight and watertight. Although thesealing pad2 in the preferred embodiment is singular and flat and is folded164 over only one, less than or more than one folding164 or molded forms of thesealing pad2 can be used and more than onesealing pad2 can be used. The skin covering can have bulbous32 ends or can be flat or have invagination31s. Thesealing pad2 can have bulbous32 ends or can be flat or have invagination31s. Thesealing pad2 can have a different radius that varies from distal to proximal.FIG. 65D is an embodiment of the cast cover in its final positioning with thesealing pad2 and the skin covering castcover3 in place and creating an airtight and watertight seal with thebody part8, a limb, the arm.
• FIGS. 66A and 66B arefixations methods11 anddevices11 that can include overlapping strands.FIG. 66A shows a lattice or web or integral or interconnected strands andFIG. 66B show a weave that can be used with a condom catheter. The first method and structure can include strands that can be overlapping or non-overlapping and which in the preferred embodiment can include a gel material that can include a tackifying material or an adhesive106 or which can be naturally tacky or: a fabric-like material that can include amicrofiber140 with a high coefficient of friction and increased drag on theskin1 when the material when aforce165 is exerted, such as pulling. When theforce165 is exerted on thefixation device11, the portions of the fixation in contact with theskin1 exert an increased coefficient of friction or drag that can increase or accumulate the more thefixation device11 is pulled upon. This embodiment is based at least in part on an increase in the surface area of the high-coefficient material that is in contact with theskin1. A second method and structure and embodiment of thefixation11 can include afixation device11 that is in the shape of a weave168 that can resemble the weave of a Chinese Finger Puzzle. The weave168 when exposed to aforce165, such as a pulling force, will tighten in some areas and not in other areas. The weave168 when exposed to aforce165 will tighten and narrow the diameter of the fixation device and constrict or narrow167 around thebody part8. Thefixation device11 can be formed from a high coefficient of friction material that at least a portion of thefixation device11 can include a gel that can include a tackifying material or an adhesive106 or which can be naturally tacky; or a fabric-like material that can include amicrofiber140 with a high coefficient of friction and increased drag on the skin. Thefixation device11 can be associated with asealing pad2 and askin covering material3. At least a component of thesealing pad2 and the skin covering material can be composed of a gel or amicrofiber140. These embodiments represent both a method and a device.
• FIGS. 67 A and B are sagital views of an embodiment of a method and a device to increase the coefficient of friction in thesealing pad2 which can include both the gel and themicrofibers140 portions of thesealing pad2 with ends that contact theskin1 that are with a concave or wave or meniscoid-like169.FIG. 67 A depicts the cross-sectional view ofgel sealing pad2protrusions132 ormicrofibers169 in which the configuration increases the capillary action or suction between the skin and the gel sealing pad or microfbers.FIG. 67 B depicts asealing pad2 with a concave or wave or meniscoid-like configuration169 that contact theskin1 that can be included within a portion of thegel sealing pad2. This configuration increases the capillary action or suction between theskin1 and thegel sealing pad2.

Claims (22)

1. An air-tight and water-tight sealing pad for use with a portion of a user's body, the sealing pad comprising:

a sealing pad cushion made of a gelatinous elastomeric material having a first side facing toward the user's body and a second side opposite the first side facing away from the user's body, wherein the first side of the sealing pad cushion is configured to contact the user's body;

a flange extending from the second side of the sealing pad cushion; and

a skin covering coupled to the sealing pad cushion and configured to cover a portion of the user's body, wherein the sealing pad forms an air-tight and water-tight seal with a portion of the user's body.

2. The sealing pad ofclaim 1 wherein the skin covering is connected to the flange.

3. The sealing pad ofclaim 1 wherein the flange is a first flange, the sealing pad comprising a second flange extending from the sealing pad cushion generally parallel with the first flange.

4. The sealing pad ofclaim 3 wherein the first and second flanges are shaped to receive and hold the skin covering between them.

5. The sealing pad ofclaim 4 wherein the skin covering has a rim that is engaged by the first and second flanges to removably hold the skin covering relative to the sealing pad cushion.

6. The sealing pad ofclaim 1 wherein the flange is integral with the sealing pad cushion and is made of a gelatinous elastomeric material.

7. The sealing pad ofclaim 1 wherein the skin covering is a face mask configured to cover at least one of the nose and mouth of a user, and wherein the flange is configured to inhibit passage of exhaled gasses from the user.

8. The sealing pad ofclaim 1 wherein the flange is made of a non-gelatinous material.

9. A device for affixing to a portion of a user's body, the device comprising:

a sheet of gelatinous elastomeric material; and

a sealing pad made of a gelatinous elastomeric material coupled to the sheet of gelatinous elastomeric material, wherein the gelatinous elastomeric material has a high coefficient of friction with the user's body, wherein the sheet of gelatinous elastomeric material exerts a compressive force upon the portion of the user's body when elongated by pulling.

10. The device ofclaim 9, wherein a portion of the gelatinous elastomeric material further comprises a microfiber material.

11. The device ofclaim 9 wherein the sheet of material comprises a series of strands that partially cover the portion of the user's body.

12. The device ofclaim 11 wherein the strands are woven together in a web-like structure.

13. The device ofclaim 9 wherein the sheet of material comprises a solid sheet of material.

14. The device ofclaim 9 wherein the portion of the user's body comprises at least one of a head, an ear, a nose, a lip, a limb, a penis, a finger, or toe, a hand, or a foot.

15. The device ofclaim 9, further comprising a skin covering coupled to the device and configured to cover a portion of the user's body.

16. A sealing pad for use with a skin covering, the sealing pad comprising a ring of gelatinous elastomeric material having a first surface, a second surface opposite the first surface, a proximal end, and a distal end, wherein:

the ring is configured to be positioned around an appendage of a user's body and to frictionally engage the skin of the user's body to resist movement of the ring relative to the skin;

at the distal end, the first surface of the ring is configured to be positioned nearest the skin;

the second surface is configured to engage a skin covering; and wherein

the proximal end is configured to be folded over the skin covering and at least a portion of the distal end of the ring to frictionally engage opposing sides of the skin covering to maintain the skin covering in place relative to the ring.

17. The sealing pad ofclaim 16, further comprising an annular bulbous protrusion at at least one of the proximal end of the ring and the distal end of the ring that is configured to engage the skin covering.

18. The sealing pad ofclaim 16, further comprising a recess on the first surface of the ring on at least one of the proximal and distal ends of the ring configured to engage the skin covering.

19. A method of donning a gelatinous elastomeric ring for use with a skin covering, the ring having a first surface, a second surface opposite the first surface, a proximal end and a distal end, the method comprising:

positioning the ring over an appendage of a user's body with the first surface of the ring contacting the appendage and frictionally engaging the appendage;

positioning a skin covering over the appendage;

superimposing an end of the skin covering over the distal portion of the ring and contacting the second surface of the ring; and

folding the proximal portion of the ring over the end of the skin covering with the proximal end of the second surface contacting the skin covering.

20. The method ofclaim 19 wherein at least a portion the ring comprises microfiber materials.

21. The method ofclaim 19 wherein the ring has a flat cross sectional shape.

22. The method ofclaim 19 wherein the ring has a U-shaped cross sectional shape with the proximal end and distal ends forming opposing arms of the U-shape.

Images