US20210015412A1 - Vacuum assisted lancing system with elective vacuum release and method for blood extraction with minimal pain - Google Patents

Abstract

A vacuum assisted lancing system can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state and an opening for allowing fluid communication between the vacuum chamber and an atmosphere. A method of manipulating a surface for blood extraction can include coupling a lancing system to the surface, blocking an opening, creating a vacuum, moving a lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time and commencing dissipation of the vacuum by unblocking the opening.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. Ser. No. 15/716,105 filed on Sep. 26, 2017, which is a continuation of U.S. Ser. No. 14/184,307 filed on Feb. 19, 2014, which is a continuation of U.S. Ser. No. 13/367,953 filed on Feb. 7, 2012, which is a continuation-in-part of U.S. Ser. Nos. 12/689,570; 12/689,608; 12/689,618; 12/689,641; and Ser. No. 12/689,657; each of which was filed on Jan. 19, 2010. The entire contents of each of the foregoing applications is hereby incorporated by reference herein.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• Not applicable.
REFERENCE TO APPENDIX
• Not applicable.
BACKGROUND OF THE INVENTIONField of the Invention
• The invention disclosed and taught herein relates generally to blood extraction devices and methods. More specifically, the invention relates to vacuum assisted lancing devices and methods useful for extracting a quantity of blood for sampling or testing.
Description of the Related Art
• There are many medical reasons where a small quantity of blood needs to be drawn from a human. Determining blood glucose levels for diagnosis and treatment of diabetes is one of the most common applications where access to blood is required. Diabetes has become a significant health risk in the United States and other parts of the world. The rise in diabetes has caused alarm in the medical community. Major companies, research institutions, and the consuming public are collectively spending significant resources for the prevention, testing, and treatment of diabetes. A person with diabetes is generally required to test their blood several times a day for glucose levels and take corrective action if needed. Failure to test and take corrective action when necessary can result in injury, both long and short term degradation of the human body's functions, and in some cases death.
• Currently, the market provides an assortment of devices that lance the skin producing a wound or other opening from which blood can be extracted. However, most require testing on an area of a user's skin that has a high concentration of blood vessels near the surface of the skin so that the lance can produce an acceptable quantity of blood. The most common area for testing is the finger tips, although the toes have also been used. However, these heavily vasculated areas of the human body are typically highly sensitive, having a rich supply of nerve endings. As a result, blood rich areas, such as the finger tips, often are more pain sensitive than other less vasculated areas. Thus, the very areas that are ideally suited for extracting blood for testing are the most sensitive to pain.
• For those individuals who are required to test themselves, the frequent testing can have negative effects on their emotional health, physical health, and even personalities. At the least, in an effort to avoid pain, they are motivated to not test as often as required by their physician. A loss of frequency and continuity in the testing can lead to physical and emotional complications, or a significant loss of accuracy in determining proper dietary corrections and medicine regiments. Health care practitioners may also be required to lance a patient's skin to extract blood for testing, which is typically done in the fingers. In some situations, however, the fingers and toes may not be available for testing, such as when these areas of the patient's body are bandaged or injured, and an alternative testing site on the patient's body may be required.
• Some blood extraction devices simply lance the skin and the patient manually squeezes the area to produce the required quantity of blood. Other blood extraction devices seek to use a vacuum to enhance the blood recovery from the lancing. However, in surveying the market of such devices, the inventor has realized that the vacuum assisted devices are either not portable with mechanized vacuum pumps, which can significantly diminish their value for mobile patients, or require unwanted maintenance, such as replacement of batteries, which are not always available. Further, many of such devices fail to adequately produce a desirable quantity of blood from portions of the skin other than the fingers and toes. Newer devices house multiple lances in the same holder, and with each use a new lance is automatically selected and used such that the patient never uses the same lance twice. Many, if not all, of these devices, including the ones that apply a vacuum, have been unsuccessful in reliably extracting sufficient quantities of blood from areas of the skin less painful than the fingers and toes. Reduction or elimination of pain has been shown to appreciably encourage the patient to follow the testing procedure prescribed by an attending physician.
• While each of these devices may have certain limited applications, there remains a need to provide a simplified and improved vacuum assisted lancing device that can be routinely used at various places on the skin and still extract a sufficient quantity of blood for the required test.
BRIEF SUMMARY OF THE INVENTION
• A vacuum assisted lancing system for blood extraction can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state, and an opening for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system can include means for selectively commencing dissipation of the vacuum. A method of manipulating a surface for blood extraction can include coupling the lancing system to the surface, blocking the opening, creating a vacuum, moving the lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum by unblocking the opening.
• A vacuum assisted lancing system for blood extraction can include a body having a central longitudinal axis, a lancing end and a free end, a lancing mechanism coupled with the body and adapted to removably couple with a lance, a vacuum mechanism coupled with the body and including a piston slideably coupled with the body so that a vacuum chamber can be formed between the piston and the lancing end of the body, a release mechanism adapted to selectively hold the vacuum mechanism in an energized state, and an opening through the body that can allow fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The opening through the body can be adapted to be sealingly engaged by a user so that the user can selectively block and unblock the opening.
• The release mechanism can include a release, and the opening can be disposed in the release. The release can have an activated position, and the opening can be adapted to be at least partially blocked when the release is in the activated position. The system can include a valve coupled to the opening, and can include a tubular lance guide removably coupled to the body and adapted to sealingly engage a surface to be lanced. The lance guide can have a transparent viewing area for viewing the surface. The system can include a depth controller coupled to the body and adapted to sealingly engage a surface to be lanced. The depth controller can be fixed or adjustable and can include a spacer having a variable thickness. The system can include a lance coupled to the lancing mechanism.
• A vacuum assisted lancing system for blood extraction can include a body having a first end adapted to sealingly engage a surface to be lanced, a longitudinally opposite second end, and a vacuum chamber between the first and second ends, means for creating a vacuum in the vacuum chamber and acting on the surface, means for disposing a lance in contact with the surface while the vacuum is acting on the surface, and means for selectively commencing dissipation of the vacuum after the vacuum has acted on the surface for a period of time. The means for selectively commencing dissipation of the vacuum can include an opening through the body for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The means for creating a vacuum can include a release coupled to the body, and the opening through the body can be disposed through the release. The system can include means for simultaneously initiating creation of the vacuum and at least partially blocking the opening. The system can include means for dissipating the vacuum at a controlled rate. The system can include a lance coupled to the means for disposing a lance in contact with the surface.
• A method of manipulating a surface for blood extraction can include coupling a lancing system to the surface, blocking an opening, activating the lancing system, thereby creating a vacuum, subjecting the surface to the vacuum, and moving a lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum. Commencing dissipation of the vacuum can include unblocking the opening and allowing the surface to fluidicly communicate with an atmosphere surrounding the lancing system while the lancing system is coupled to the surface.
• The lancing system can include a release coupled with the opening, and the blocking and activating steps can be accomplished simultaneously by engaging and holding the release. Commencing dissipation of the vacuum can include disengaging the release. Blocking the opening can include sealingly engaging the opening with a finger or other body, and unblocking the opening can include disengaging the opening and the finger or other body. The lancing system can include a lance removably coupled to a lance coupler, and the method can include lancing the surface. The method can include maintaining the vacuum for a period of time after the surface has been lanced, and can include verifying that an amount of blood has been extracted prior to commencing dissipation of the vacuum.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
• FIG. 1 is an isometric schematic view of one of many embodiments of a vacuum lance system according to the disclosure.
• FIG. 2 is an isometric assembly schematic view of the vacuum lance system ofFIG. 1.
• FIG. 3A is a cross-sectional schematic view of another of many embodiments of a vacuum lance system having an indicator according to the disclosure.
• FIG. 3B is a cross-sectional schematic view of the indicator ofFIG. 3A in a viewing window.
• FIG. 4 is a cross-sectional schematic view of one of many embodiments of a lancing mechanism according to the disclosure.
• FIG. 5A is an illustration of one of many embodiments of a vacuum lance system in a cocked position according to the disclosure.
• FIGS. 5B, 5C and 5D are illustrations of the system ofFIG. 5A in three respective positions during lancing.
• FIG. 5E is an illustration of the system ofFIG. 5A in an uncocked position.
• FIG. 5F is an illustration of the system ofFIG. 5A manipulating a surface during lancing.
• FIG. 5G is an illustration of the system ofFIG. 5A vibrating a surface during lancing.
• FIG. 5H is a graph illustrating one example of the vacuum magnitude versus the time over which lancing can occur during a vacuum cycle according to the disclosure.
• FIG. 6 is a front isometric schematic view of one of many embodiments of a vacuum lance system having a depth controller according to the disclosure.
• FIG. 7A is a cross-sectional schematic view of the system ofFIG. 6.
• FIG. 7B is a cross-sectional schematic view of the system ofFIG. 6 with a base contacting a spacer.
• FIG. 7C is a cross-sectional schematic view of the system ofFIG. 6 during blood extraction.
• FIG. 8A is an illustration of one of many embodiments of a vacuum lance system having a lance tool according to the disclosure.
• FIG. 8B is an illustration of a lance being inserted into a lance coupler with the lance tool ofFIG. 8A.
• FIG. 8C is an illustration of a lance being coupled to the lance coupler with the lance tool ofFIG. 8A.
• FIG. 8D is an illustration of a lance being removed from the lance coupler with the lance tool ofFIG. 8A.
• FIG. 9 is a cross-sectional schematic view of one of many embodiments of a vacuum lance system having an external vacuum indicator according to the disclosure.
• FIG. 10 is a cross-sectional schematic view of one of many embodiments of a vacuum lance system having an external vacuum assembly according to the disclosure.
• FIG. 11 is an isometric schematic view of another of many embodiments of a vacuum lance system according to the disclosure.
• FIG. 12 is an isometric assembly schematic view of the vacuum lance system ofFIG. 11.
• FIG. 13A is a cross-sectional schematic view of the vacuum lance system ofFIG. 11 in a cocked position.
• FIG. 13B is a cross-sectional schematic view of the vacuum lance system ofFIG. 11 in an uncocked position.
• FIG. 14 is a cross-sectional schematic view of one of many embodiments of a lancing mechanism according to the disclosure.
• FIG. 14A is a cross-sectional schematic view of the release mechanism ofFIG. 14 coupled to the main shaft before activation.
• FIG. 14B is a cross-sectional schematic view of the release mechanism ofFIG. 14A uncoupled from the main shaft after activation.
• FIG. 14C is a schematic view of another of many embodiments of a release mechanism in a deactivated position according to the disclosure.
• FIG. 14D is a schematic view of the release mechanism ofFIG. 14C in an activated position according to the disclosure.
• FIG. 14E is a schematic view of yet another of many embodiments of a release mechanism in a deactivated position according to the disclosure.
• FIG. 14F is a schematic view of the release mechanism ofFIG. 14E in an activated position according to the disclosure.
• FIG. 15A is an illustration of the vacuum lance system ofFIG. 11 in a cocked position according to the disclosure.
• FIG. 15B is an illustration of the vacuum lance system ofFIG. 15A in one of many activated positions wherein the first and second portions of the shaft coupler are coupled according to the disclosure.
• FIG. 15C is an illustration of the vacuum lance system ofFIG. 15A in another of many activated positions wherein the first and second portions of the shaft coupler are uncoupled according to the disclosure.
• FIG. 15D is an illustration of the vacuum lance system ofFIG. 15A in another of many activated positions wherein the opening in the release is sealed according to the disclosure.
• FIG. 15E is an illustration of the vacuum lance system ofFIG. 15A in another of many activated positions wherein the opening in the release is not sealed according to the disclosure.
• FIG. 15F is an illustration of the system ofFIG. 15A in an uncocked position.
• FIG. 15G is a graph illustrating another example of vacuum magnitude versus a time over which lancing can occur during a vacuum cycle according to the disclosure.
• FIG. 16 is an isometric schematic view of yet another of many embodiments of a vacuum lance system according to the disclosure.
• FIG. 17 is an isometric assembly schematic view of the vacuum lance system ofFIG. 16.
• FIG. 18 is a schematic view of one of many embodiments of a vacuum lance system having an adjustable depth controller in a first position according to the disclosure.
• FIG. 19 is a schematic view of the system ofFIG. 18 with the adjustable depth controller in a second position.
DETAILED DESCRIPTION OF THE INVENTION
• The Figures described above and the written description of specific structures and functions below are not presented to limit the scope of what Applicant has invented or the scope of the appended claims. Rather, the Figures and written description are provided to teach any person skilled in the art to make and use the invention for which patent protection is sought. Those skilled in the art will appreciate that not all features of a commercial embodiment of the invention are described or shown for the sake of clarity and understanding. Persons of skill in this art will also appreciate that the development of an actual commercial embodiment incorporating aspects of the present invention will require numerous implementation-specific decisions to achieve the developer's ultimate goal for the commercial embodiment. Such implementation-specific decisions may include, and likely are not limited to, compliance with system-related, business-related, government-related and other constraints, which may vary by specific implementation, location, and from time to time. While a developer's efforts might be complex and time-consuming in an absolute sense, such efforts would be, nevertheless, a routine undertaking for those of ordinary skill in this art having benefit of this disclosure. It must be understood that the invention disclosed and taught herein is susceptible to numerous and various modifications and alternative forms. Lastly, the use of a singular term, such as, but not limited to, “a,” is not intended as limiting of the number of items. Also, the use of relational terms, such as, but not limited to, “top,” “bottom,” “left,” “right,” “upper,” “lower,” “down,” “up,” “side,” and the like are used in the written description for clarity in specific reference to the Figures and are not intended to limit the scope of the invention or the appended claims. When referring generally to such elements, the number without the letter is used. Further, such designations do not limit the number of elements that can be used for that function. The terms “couple,” “coupled,” “coupling,” “coupler,” and like terms are used broadly herein and can include any method or device for securing, binding, bonding, fastening, attaching, joining, inserting therein, forming thereon or therein, communicating, or otherwise associating, for example, mechanically, magnetically, electrically, chemically, operably, directly or indirectly with intermediate elements, one or more pieces of members together and can further include without limitation integrally forming one functional member with another in a unity fashion. The coupling can occur in any direction, including rotationally.
• This disclosure provides a vacuum assisted lancing system and method that can be easily used at a wide variety of places on a human or animal, even in places with less sensitivity, such as the stomach, sides, arms and legs. The system can be used with one hand and is easily portable. The system can minimize pain due to its ability to operate on unconventional areas on a user, and in at least one embodiment minimizes pain due to vibration during lancing. The term “user” and like terms are used broadly herein and include, without limitation, a person who uses the present invention on his/her self, or a person (or animal) for whom another person uses the present invention to lance the person (or animal). The system's vibration can at least partially mask any pain from a patient during lancing. Further, the lance itself can be easily replaced from a position external to the system with simple insertion. Not requiring batteries, nor containing any form of motor, the system is virtually maintenance free, other than replacement of the lance after use and occasional common cleaning. The system can be easily carried to be readily available wherever the user needs to take a blood sample. Integration of this system into the common mainstream method of blood glucose measurement can be significantly assisted because the system draws from the same pool of body blood as other devices. Therefore, special glucose measuring instruments and supplies may not be required, and blood measurement procedures may not have to be altered from those currently in practice.
• FIG. 1 is an isometric schematic view of one of many embodiments ofvacuum lance system100 according to the disclosure.FIG. 2 is an isometric assembly schematic view of the vacuum lance system ofFIG. 1.FIG. 3A is a cross-sectional schematic view of another of many embodiments ofvacuum lance system100 having anindicator133 according to the disclosure.FIG. 3B is a cross-sectional schematic view of theindicator133 ofFIG. 3A inviewing window135.FIG. 4 is a cross-sectional schematic view of one of many embodiments of lancingmechanism118 according to the disclosure.FIGS. 1-4 will be described in conjunction with one another.Vacuum lance system100 can include adevice body102, which can comprise, for example, a tubular vacuum body, for supporting one or more components for lancing.Device body102 can have abottom lancing end104 and a topfree end106, and can, but is need not, be transparent, in whole or in part.Device body102 can be formed from any material, such as plastic, metal, or another material, separately or in combination, and can be any size required by a particular application.System100 can, but need not, include agrip103, such as a foam, rubber, plastic, or other holder, for holding the system.System100 can, but need not, include aholder131, such as a belt clip, pocket clip, loop, or other holder, for supporting the system, for example, when not in use.
• System100 can include one or more components for lancing (the components collectively referred to herein as a lancing assembly), which can include one or more components for vacuuming, coupled todevice body102.System100 can include alance guide112, such as a tube, coupled to lancingend104, such as for “aiming”system100 or for contacting a lancing surface, such as skin, for lancing, directly or indirectly. Lance guide112 can be any size required by a particular application, and can advantageously include aviewing area114 for viewing the surface being lanced.Viewing area114 can be a “window” coupled to the wall oflance guide112, or as another example,lance guide112 can be transparent, in whole or in part. Lance guide112 can, but need not, have aseal116, such as an annular seal coupled to its bottom end for sealing against a surface being lanced or, as another example, for at least reducing discomfort to a user whensystem100 is pressed against an area of the user's body for lancing.Seal116 can be, for example, a rounded or contoured edge, a soft coating, such as a rubber coating, a pad, a gasket, or another seal, in whole or in part. As another example, in at least one embodiment, which is but one of many, seal116 can be a suction cup (see, e.g.,FIG. 9).Seal116 can, but need not, be flexible. For example, seal116 can have an amount of flexibility, so thatlance system100 does not have to be held substantially perpendicular to a lancing surface to assure sealing engagement with the surface.Seal116 can, but need not, include or be formed from, in whole or in part, a material that has gripping properties, for example, so that if the seal is moved or rotated while in contact with a surface, such as skin, the surface concurrently moves or rotates.
• With further reference toFIGS. 1 and 2,system100 can include alancing mechanism118 coupled to lancingend104, for example, to endcap108, for supporting a lance120 (also known as a “lancet”).Lance120 can include alance base120afor supporting alance needle120b.Lancing mechanism118 can include a lancingshaft122 slideably coupled withend cap108, such as along central longitudinal axis X, for communicatinglance120 with a surface during lancing. Lancingshaft122 can include a bottomlance coupling end124 and atop actuating end126, and can be any length required by a particular application, as will be further described below.Lancing mechanism118 can include alance coupler128 coupled to lance couplingend124 forcoupling lance120 toshaft122, removably or otherwise. For example,lance coupler128 can be tubular and can form an interference or friction fit withlance base120a.Lance coupler128 can, but need not, be adjustable, such as by having a slot or notch at least partially along its length, for example, for coupling to lances of one or more sizes or shapes. As other examples,lance coupler128 can include threads, screws, notches, or other fasteners for coupling to a lance, as will be understood by one of ordinary skill in the art.Lancing mechanism118 can include one or more biasing devices, such as a lancingspring130. Lancingspring130 can be coupled to lancingshaft122 for biasingshaft122 in one or more directions, temporarily, momentarily or otherwise, as will be further described below. Lancingspring130 can, but need not, comprise a plurality of springs, and can advantageously include two springs.
• System100 can include avacuum mechanism132 for creating a vacuum and communicating with lancingmechanism118 or other components ofsystem100.Vacuum mechanism132 can include amain shaft134 having a bottommain actuating end136, a top mainfree end138, and at least onerelease coupler140, such as, for example, a notch or indention.Main shaft134 can be slideably coupled withtop end cap110, for example, so thatmain actuating end136 can be disposed insidedevice body102 and mainfree end138 can be disposed outsidedevice body102.System100 can, but need not, include aknob146, such as a button or cap coupled to mainfree end138, for manipulatingmain shaft134 or other components.System100 can include arelease mechanism142, such as a firing device, for communicating withmain shaft134, for example, for releasably coupling withrelease coupler140, a series of release couplers, or another portion ofmain shaft134.Release mechanism142 can be any type of releasable coupler, adapted to cooperate withmain shaft134, as will be understood by one of ordinary skill in the art. For example,release mechanism142 can couple withmain shaft134 at one or more positions along its length, such as withrelease coupler140, a series thereof or, for example, a notch, groove or outer surface, to releasably holdmain shaft134 in a particular position until, for example,release144 is actuated, as will be further described below.Vacuum mechanism132 can include apiston148 coupled tomain shaft134 for communicating with one or more other components ofsystem100 to create a vacuum.Piston148 can be coupled, adjustably, fixedly or otherwise, anywhere onmain shaft134 inside ofdevice body102, such as, for example, tomain actuating end136.Piston148 can, but need not, include one or more seals, such as one or more O-rings150, and can sealingly communicate withinterior wall152 ofdevice body102, which can, for example, form avacuum chamber154inside device body102 betweenpiston148 and a surface to be lanced in communication withseal116.
• System100 can include one ormore openings156, such as an air passage or orifice, for fluid communication betweenvacuum chamber154 and an atmosphere surrounding the vacuum chamber. Opening156 can be calibrated to allow air to flow intovacuum chamber154 at a predetermined vacuum dissipation rate, such as, for example, a vacuum dissipation rate less than a predetermined vacuum generation rate invacuum chamber154. Opening156 can be any suitable place for communicating with a vacuum insystem100, such as in device body102 (see, e.g.,FIG. 9), and can advantageously, but need not, be inpiston148, separately or in combination. Eachopening156 can, but need not, be adjustable in size, which may include having an adjustable diameter or being interchangeable, separately or in combination. One ormore openings156 can afford any rate of vacuum dissipation required by a particular application, such as a linear rate, non-linear rate, or another rate, in whole or in part, separately or in combination.
• Vacuum mechanism132 can include a biasing device, such asvacuum spring158, coupled topiston148 for biasingpiston148 in one or more directions, such as in the upward direction.Vacuum spring158 can, but need not, include a compression spring disposed betweenbottom end cap108 andpiston148 that biases the piston away frombottom end cap108. Alternatively, or collectively, for example,vacuum spring158 can include a tension spring thatbiases piston148 towardtop end cap110, such as a tension spring disposed betweenpiston148 andtop end cap110, as will be understood by one of ordinary skill in the art having the benefits of this disclosure.Vacuum spring158 can, but need not, include a plurality of springs.
• System100 can include avacuum indicator133 for indicating whether or to what extent a vacuum exists withinvacuum chamber154. For example,indicator133 can indicate when a vacuum having at least a predetermined magnitude is present in the system or, as another example, when a vacuum below the predetermined magnitude can be present, including when no vacuum is present. In at least one embodiment, which is but one of many,indicator133 can be a visual indicator, such as a tab, mark, colored media, notch, or other visible indicator, coupled tomain shaft134,piston148, or another component, so thatindicator133 can visually indicate, such as by being visible, when no vacuum or a vacuum below a predetermined magnitude is present in the system.Indicator133 can be visible, for example, through a slot, window, portion ofdevice body102, or other transparent media, which can be any size or shape. As shown inFIGS. 3A and 3B, for example,indicator133 may not be visible, such as being insidedevice body102, while a vacuum having a predetermined magnitude can be present in the system, and can become visible, such as by passing through a portion offree end106 and intoindicator window135 when no vacuum or a vacuum below a predetermined magnitude is present in the system. As another example,indicator133 can be visible through at least a portion ofdevice body102, through an elongated window disposed longitudinally alongdevice body102, or through a combination thereof. Alternatively,indicator133 need not be visible throughdevice body102 and can be visible only when outside ofdevice body102, in whole or in part (see, e.g.,FIGS. 5A-5E). For example, and without limitation,indicator133 can be a marking onshaft134 which only becomes visible outside of device body102 (e.g., above release mechanism142) whenshaft134 has sufficiently exitedfree end106, so as to indicate that the vacuum has fallen below a predetermined value. In at least one of many alternative embodiments,indicator133 can be an audible indicator, digital indicator, electrical indicator, electronic indicator or, as other examples, a pressure sensitive indicator or mechanical indicator, separately or in combination.Indicator133 can, but need not, indicate to a user when a vacuum insystem100 during lancing is sufficiently dissipated (i.e., is of sufficiently low magnitude) thatsystem100 can be removed from a surface being lanced. For example, in an application where skin is being lanced for purposes of drawing blood,indicator133 can indicate whensystem100 can be removed from the skin so that the drawn blood does not splatter, such as could happen due to an inrush of atmospheric air, e.g., ifseal116 were to be lifted off the skin with a relatively high vacuum invacuum chamber154.
• System100 can include ashaft coupler160 for releasably coupling one or more components ofsystem100, such as lancingshaft122 andmain shaft134.Shaft coupler160 can include two or more portions that optionally couple with one another. For example,shaft coupler160 can include afirst portion160acoupled to lancingshaft122, such as to actuatingend126, and asecond portion160bcoupled tomain shaft134, such as tomain actuating end136.First portion160aandsecond portion160bcan be adapted to releasably couple to one another when brought at least proximate to one another and to uncouple upon a predetermined event, for example, when a sufficient force applied toshaft coupler160. In at least one embodiment, which is but one of many, one ofportions160a,160bcan be a magnet and the other portion can be magnetic material, which can allow, for example, lancingshaft122 andmain shaft134 to remain coupled until a separation force, such as a tensile force, is applied sufficient to overcome the coupling force betweenfirst portion160aandsecond portion160b. Alternatively, or collectively, eitherportion160a,160bcan be a portion of one of theshafts122,134, such as one of the actuating ends126,136, or, as another example,second portion160bcan be coupled to, including formed integrally with,piston148. In at least one other embodiment, which is but one of many, first and second portions ofshaft coupler160 can include hook and loop material, mechanical fasteners, ball and joint unions, sticky material, or other couplers, as required by a particular application. In at least one embodiment, which is but one of many, a sufficient separation force can be any force less than a force generated by the vacuum spring158 (see, e.g.,FIG. 2).
• With reference toFIG. 4, lancingmechanism118 can, but need not, includebottom end cap108. Alternatively, lancingmechanism118 can be separately coupled tobottom end cap108 or another portion of lancingend104 ofdevice body102. Lancingspring130 can include a plurality of springs, such asupper spring130aandlower spring130b(collectively referred to herein as lancing spring130).Lancing mechanism118 can include astop129, such as a tab or block, for supporting lancingspring130 or defining the stroke of lancingshaft122, in whole or in part. In at least one embodiment, such as the embodiment shown inFIG. 4, which is but one of many, stop129 can be disposed betweenlance coupling end124 and actuatingend126 of lancingshaft122.Upper spring130acan be coupled betweenstop129 and actuatingend126, andlower spring130bcan be coupled betweenstop129 andlance coupling end124. Each lancingspring130a,130bcan be loosely disposed aboutshaft122 or can have one or more ends fixedly coupled toshaft122 or stop129, separately or in combination. Each lancingspring130a,130bcan be any type of spring, or other biasing device, and can have any K value or length required by a particular application. Lancingshaft122 can have a resting state, which can be at least partially defined by communication betweensprings130a,130band stop129, separately or in combination with one or more other components ofsystem100. For example, whenshaft122 is at rest, one or more ofsprings130a,130bcan, but need not, be in their natural state (i.e., neither compressed nor extended). Alternatively, one or more springs can be under tension or compression when lancingshaft122 is at rest or, as another example, while lancingshaft122 is in motion, such as during lancing, as required by a particular application and as will be understood by one of ordinary skill. When lancingshaft122 is in a rest position,lance needle120bcan, but need not, be distal from asurface168 being lanced, such as skin (see, e.g.,FIG. 5F). Lancingshaft122 can be any length required by a particular application and can be slideably coupled withstop129 so that lancingspring130 can biasshaft122, such as in the upward or downward direction, as will be further described below.
• FIG. 5A is an illustration of one of many embodiments of avacuum lance system100 in a cocked position according to the disclosure.FIGS. 5B, 5C and 5D are illustrations of thesystem100 ofFIG. 5A in three respective positions during lancing.FIG. 5E is an illustration of thesystem100 ofFIG. 5A in an uncocked position.FIG. 5F is an illustration of thesystem100 ofFIG. 5A manipulating a surface during lancing.FIG. 5G is an illustration of thesystem100 ofFIG. 5A vibrating a surface during lancing. At least one of many methods of using the embodiment ofsystem100 shown inFIGS. 5A-5G can be described.FIG. 5H is a graph illustrating the vacuum magnitude versus the time over which lancing can occur during a vacuum cycle.FIGS. 5A-5H will be described in conjunction with one another.
• Alance120 can be coupled to lancingmechanism118, such as by using one of the methods described herein, for example, before or aftersystem100 is in a “cocked” position (see, e.g.,FIG. 5A).System100 can be cocked, for example, by pressingknob146 downward until at least a portion ofmain shaft134, such asrelease coupler140, couples withrelease mechanism142, which can releasably holdmain shaft134 andpiston148 downwardly toward lancingend104, such as against the force ofvacuum spring158. Shaft couplersecond portion160bonmain actuating end136 can couple tofirst portion160aofshaft coupler160 on actuatingend126 of lancingshaft122. Actuatingend126 can, but need not, move downwardly during cocking, temporarily or otherwise.Upper spring130aandlower spring130bcan, but need not, be in their natural states.System100 can engage a surface to be lanced (not shown), such as to an area of skin on a person's body, which can be any area. For example, seal116 onlance guide112 can engage the surface so that at least a partially airtight seal is formed betweenseal116 and the surface.
• System100 can be activated, or fired, for example, by actuatingrelease144, which can at least partially uncouplemain shaft134 and, for example,release coupler140, fromrelease mechanism142, which can allowmain shaft134 to slideably communicate withtop end cap110. Release144 can be pressed directly, such as with a user's finger, or indirectly actuated, for example, using a magnet, electrical or mechanical actuator, or another method, as required by a particular application.Vacuum spring158 can at least partially decompress (or lose tension if a tension spring, as mentioned above and further described below) andpiston148,main shaft134 andshaft coupler160 can move in the upward direction away from the surface being lanced.Piston148, which can, but need not, include one or more seals, such as O-rings150, can be in sliding sealing engagement withinterior wall152 ofdevice body102, thereby at least partially forming a vacuum invacuum chamber154 aspiston148 moves away from the surface being lanced. One or more components of lancingmechanism118, such as actuatingend126 and lancingshaft122 can move upward withmain shaft134, for example, due to the coupling force ofshaft coupler160 and the force of expandingvacuum spring158.Upper spring130acan expand andlower spring130bcan contract, which can, for example, singularly or in combination, exert an increasing force onfirst portion160aofshaft coupler160 in the opposite direction (e.g., downward) of the force exerted onsecond portion160bby vacuum spring158 (e.g., upward) asvacuum spring158 expands (FIG. 5B). Lancingshaft122 can have a shorter stroke thanmain shaft134. For example, stop129 can limit the stroke of lancingshaft122, for example, by preventing at least a portion ofshaft122 from traveling upward past the stop or, as another example, lancing spring130 (referring collectively tosprings130aand130b) can be arranged to limit the stroke of lancingshaft122, separately or in combination withstop129. In at least one embodiment, which is but one of many, lancingspring130 can have, for example, a length or K-value that can result in a lancing spring force greater than the coupler force ofshaft coupler160 when lancingshaft122 is in a particular position, which can be any position required by a particular application.
• Shaft coupler160 can uncouple andsecond portion160bcan continue moving in the upward direction (FIG. 5C).Piston148 can continue moving upward during and after penetration of the surface, continuously or in segments, such as by using two ormore release couplers140 that successively couple to releasemechanism142, which can increase the vacuum to which the surface can be exposed.Upper spring130acan contract andlower spring130bcan expand, singularly or in combination, which can, for example, causefirst portion160ato move in the opposite (i.e., downward) direction fromsecond portion160bofshaft coupler160. Lancingshaft122 may be drawn back away from the surface and the coupling force betweenportions160aand160bmay be overcome.Lancing mechanism118 can move toward a rest position, such as due to the force of one or more springs130. Lancingshaft122 can move downwardly, such as until at least a portion oflance120 contacts the surface (FIG. 5D). In at least one embodiment, which is but one of many, lancingshaft122 can, but need not, move downwardly far enough thatupper spring130 at least partially compresses andlower spring130bat least partially expands aslance120 lances the surface. As will be understood by one of ordinary skill, inertia may cause lancingshaft122 to move past its rest position (e.g., downward), for example, so thatlance needle120bmay pierce the surface, before returning to its rest position. After at least partially penetrating the surface, each ofsprings130a,130band lancingshaft122 can return to a state of rest (FIG. 5E), andlance120 can be disposed upwardly and distally from the surface.
• The surface can be subjected to a vacuum before, during, or after lancing, separately or in combination. Air can enter vacuum chamber154 (selectively, automatically, or otherwise), such as throughopening156, which can dissipate the vacuum at any rate required by a particular application.Indicator133, such as a tab, groove, or mark, can become visible, such as by passing outside ofdevice body102, which can indicate dissipation of the vacuum, in whole or in part.System100 can be disengaged from the surface, which can leave a quantity of blood on the surface for collection.
• Asurface168 being lanced can, but need not, be manipulated during lancing, which can include twisting, pumping, pressing up and down, or any movement, separately or in combination (see, e.g.,FIG. 5F). For example, wheresurface168 is skin, one or more components on lancingend104 ofdevice body102, such aslance guide112 orseal116, can be used to knead, massage or otherwise manipulate the skin at any time during the lancing process, for example, before, during or after the skin is lanced, which can result in a greater volume ofblood176 being extracted and/or more rapid blood extraction. As an example of this manipulation, seal116 can be placed against the skin and twisted in one or more directions, such as back and forth, clockwise, then counterclockwise (or vice versa), for example, so that the skin twists, such as due to friction between the skin and seal116, which can increase blood flow to the area being lanced or out of an opening in the skin made bylance120. The surface ofseal116 can be made of or coated with a gripping type substance, such as to aid in twisting the surface whenseal116 is being twisted. Another example of this manipulation, which can speed up blood drawing, can include increasing and decreasing inward pressure ofseal116 on the surface in a pulse-like action. Each of these classes of manipulation, just as with squeezing a finger if it is pricked, can speed up blood flowing through a lance-generated hole. This can be especially true in the presence of a vacuum on the surface as described in the present disclosure. The degree of manipulation, if any, of the skin can vary from surface to surface on areas of the user, and from user to user, as will be understood by one of ordinary skill having the benefits of this disclosure.
• With continuing reference toFIGS. 5A-5G, and further reference toFIG. 5H, the timing and magnitude of vacuum creation and lancing can include one or more variables, as will be understood by one of ordinary skill, each of which can have any value required by a particular application. The magnitude of the vacuum and the rate at which the vacuum can be created, the timing of lancing, such as whenshaft coupler160 uncouples, the rate at whichlance120 can travel, and the force with whichlance120 strikes a surface, or other factors can, but need not, be optimized for a particular application. Further, the vacuum creation can occur in a single stage, or in multiple stages. For example, one or more of these factors can be correlated with travel and timing of thepiston148 along a length ofdevice body102. As will be understood by one of ordinary skill in the art, thefurther piston148 travels within device body102 (e.g., away from a surface being lanced), the higher a vacuum invacuum chamber154 may be. Further, the force with whichlance120 contacts a surface, such as skin, can be at least enough to puncture or penetrate the surface, and can advantageously drive at least a portion ofneedle120bthrough the surface and into subcutaneous tissue beneath the surface from which blood may be taken. One or more variables can be defined by the length and/or K value of a spring, such as of lancingspring130 orvacuum spring158, the volume ofvacuum chamber154 or, as another example, by the weight, stroke or length of a shaft, such as lancingshaft122 ormain shaft134.
• In at least one embodiment, such as the embodiment shown inFIGS. 5A-5G, which is but one of many, the stroke of lancingshaft122 can determine whenshaft coupler160 can uncouple during lancing and whenlance120 can contact or penetrate the surface being lanced, such as during a period of time in which a vacuum can be applied to the surface. For example, upon release from a cocked position,piston148 can travel upward from a lowermost position (see, e.g.,FIG. 5A) where no vacuum exists withinvacuum chamber154 to an uppermost position (see, e.g.FIG. 5E), thereby creating a maximum vacuum withinvacuum chamber154, which can be any magnitude of vacuum, such as up to 30 inches of mercury, required by a particular application.
• As shown for illustrative purposes inFIG. 5H, lancing of a surface can occur at any time before, during, or after a vacuum cycle, as may be suitable for a particular application. For example, the lancing of the surface can occur before a vacuum is created, as indicated by reference A. Alternatively, the lancing of the surface can occur while the vacuum is increasing in the device body, as indicated by reference B, such as at ½ of peak vacuum P. As will be understood by one of ordinary skill having the benefits of this disclosure, reference B illustrates one of many lancing times during vacuum creation, and lancing can alternatively occur at any point along a line between references A and C. The lancing can also occur when the vacuum is at peak vacuum P, illustrated by reference C. In one or more other embodiments, lancing may occur after peak vacuum and before the vacuum has been entirely dissipated, such as at a point in time illustrated by reference D, which may be, for example, ⅓P, or any point in time along a line between references C and E. As another example, lancing may occur after a vacuum has dissipated, such as at the point in time illustrated by reference E.
• As described above, lancing can occur at any time during a vacuum cycle, including before, during, or after a vacuum is created, and can advantageously occur when at least a partial vacuum is created, such as between 30% and 70%, or any increment there between, of the maximum vacuum for a particular application. In at least one embodiment, which is but one of many, lancing can advantageously occur at between 40% and 60% of vacuum creation, or any increment there between, such as at 50% vacuum creation. For example, the maximum vacuum can be −20 inHg, and the surface can be lanced when the vacuum invacuum chamber154 is, for example, −10 inHg. However, this need not be the case, and the examples described herein are for illustrative purposes. The timing of lancing can, but need not, be adjustable. For example, in at least one embodiment, such as a commercial embodiment, which is but one of many,system100 can include a plurality of interchangeable lancing shafts, each of which can have a different length, which can determine when lancing occurs during a vacuum cycle, as described above.
• The rate at which the vacuum is created, which can be at least partially determined by the rate at whichpiston148 travels upward, can, but need not, be adjustable. For example, in at least one embodiment,system100 can include a shock absorber, piston or other device (not shown), for controlling the rate at whichpiston148 ascends during lancing. The vacuum can be dissipated, or released, such as throughopening156, or movement ofpiston148, separately or in combination, at any rate and at any time required by a particular application. For example, where the surface being lanced is skin, the vacuum can advantageously be released at a rate and time that may allow an adequate amount of blood for collecting to be drawn from the surface or, as another example, at a rate that can at least partially minimize blood splatter when the system is removed from the skin.
• With continuing reference toFIGS. 5A-5G,system100 can, but need not, be adapted to vibrate during lancing. The term “vibrate” and conjugations thereof are used broadly herein and specifically include, without limitation, any shake, quiver, pulsation, or other movement applied bylance system100 to a surface being lanced. One or more vibrations can be timed to occur in proximity (e.g., in time and space) to lance penetration of a surface, which can mask the sensation of penetration from the user. Vibration insystem100 can at least partially mask pain associated with lancing, if any, such as where the surface being lanced is skin. The vibration can be controlled by adjusting properties of one or more of the components, such as the dynamic components, of a particular embodiment ofsystem100, and can have any magnitude or duration required by a particular application. The magnitude of a vibration can depend on, or be predetermined by, for example, the mass of one or more components in the system, the K value of one or more springs, the stroke of one or more shafts, the momentum of one or more components, or other factors, as will be understood by one of ordinary skill having the benefits of this disclosure. One or more vibrations can occur singularly, consecutively, concurrently, supplementary or otherwise, and can occur in, or transfer to, one or more components ofsystem100. Advantageously, one or more vibrations may be present at lancingend104, for example, so that the vibrations can at least partially transfer tosurface168 during lancing (see, e.g.FIG. 5G), which can thereby aid in masking the pain of lancing. The vibration can be caused by any of the components, such as the dynamic components, of a particular embodiment ofsystem100, and can have any magnitude or duration required by a particular application. The magnitude of a vibration can depend on, or be predetermined by, for example, the mass of one or more components in the system, the K value of one or more springs, the stroke of one or more shafts, the momentum of one or more components, or other factors, as will be understood by one of ordinary skill having the benefits of this disclosure. In at least one embodiment, which is but one of many, a vibration can begin before penetration of a surface, and can, at least partially, continue during penetration of the surface. The vibration can advantageously, but need not, continue after the surface has been lanced. As other examples, one or more components of lancingmechanism118, such as lancingspring130 or lancingshaft122, can cause vibration insystem100, separately or in combination with other components in the system.
• In at least one embodiment, which is but one of many, one or more portions of the lancing assembly, such as lancingshaft122,lance coupler128, ormain shaft134, can move in a first direction, such as towardfree end106 ofdevice body102, for example, over a first distance. One or more of the portions, such asfirst portion160aofshaft coupler160, can be stopped from moving further in the first direction, such as further than the first distance, for example, bystop129, which can cause a vibration in one or more parts ofsystem100. Advantageously, the vibration continues to occur for an amount of time at least long enough for the surface to be penetrated. One or more components can move in a second direction, such as in a direction opposite the first direction, for example, toward the lancingend104 ofdevice body102. The one or more components, such as lancingshaft122 orfirst portion160aofshaft coupler160, can be stopped from further moving in the second direction, for example, past a second distance, which can cause one or more vibrations insystem100.
• FIG. 6 is a front isometric schematic view of one of many embodiments ofvacuum lance system100 having adepth controller162 according to the disclosure.FIG. 7A is a cross-sectional schematic view of thesystem100 ofFIG. 6.FIG. 7B is a cross-sectional schematic view of thesystem100 ofFIG. 6 with a base contacting a spacer.FIG. 7C is a cross-sectional schematic view of thesystem100 ofFIG. 6 during blood extraction.FIGS. 6-7C will be described in conjunction with one another.Vacuum lance system100 can include adepth controller162 for controlling the depth to which a surface is lanced during lancing.Depth controller162 can include a calibratedspacer164 and aspacer coupler166 forcoupling spacer164 to lancingend104 ofdevice body102.Depth controller162 can be formed from any material, such as plastic or metal, and can be replaceably and interchangeably coupled todevice body102 in any manner, such as being threaded thereon, forming an interference or friction fit with one or more other components ofsystem100, or fastened with fasteners, such as screws, brackets, adhesive, or other fasteners, removably, permanently or otherwise, and other method of attachment. Alternatively,depth controller162 can be fixedly coupled todevice body102, integrally or otherwise, or any portion thereof.Depth controller162 can, but need not, be transparent, in whole or in part.Spacer coupler166 can be tubular and can be coupled, for example, to lance guide112 (see, e.g.,FIG. 1) or, as another example, in place oflance guide112, as required by a particular application.Spacer164 can be coupled tospacer coupler166, including being formed integrally therewith, betweenlance120 and asurface168 being lanced. As another example,depth controller162 can be adjustable, such as by way of one or more variable components, for example, aspacer164 of varying length or thickness, as will be further described below (see, e.g.,FIG. 18).
• Spacer164 can include a central opening, such ashole170, for allowing at least a portion oflance120 to pass there through, and can have a calibrated thickness “t”, which can be any thickness required by a particular application, and which can be the same or different from the thickness of one or more portions ofspacer coupler166.Spacer164 can, but need not, be adjustable, which can include being interchangeable, individually or simultaneously withspacer coupler166, for example, to allow for spacers of different thicknesses. Hole170 (having dimension “d” inFIG. 7A) can have any shape or cross-sectional area required by a particular application, and can advantageously have a cross-sectional area larger than that ofneedle120band smaller than that ofbase120a(having dimension “D” inFIG. 7A) so thatneedle120bcan pass throughhole170 andbase120acan not, i.e., D>d (see, e.g.,FIG. 7B).Base120acan contact theupper surface172 ofspacer164 during lancing, which can limit the depth to which needle120bcan penetratesurface168, such as to the difference between length “l” ofneedle120band the thickness “t” ofspacer164. This can be advantageous, for example, because the depth of penetration ofneedle120bintosurface168 can be controlled regardless of the force with whichlance120 travels in the downward direction during lancing, which can be any force. For example, where thesurface168 is skin, the force required to thrustlance120 into the skin can vary from application to application and user to user, such as between relatively soft or thin skin and relatively tough or thick skin, such as, for example, calloused skin.
• Depth controller162 can allow, for example, a relatively large force, such as a force large enough to lance calloused skin, to also be used on softer areas of skin, for example, by stopping the travel distance ofneedle120b, so that regardless of its toughness, skin can be lanced to a depth of “l” minus “t” when thebottom surface174 of thespacer164 is adjacent the skin, i.e., a depth equal to the difference between the length “l” oflance needle120band the thickness “t” ofspacer164. As another advantageous example, where thesurface168 being lanced is skin, a blunt force or vibration can result, such as from an impact betweenupper surface172 andbase120a, which can, but need not, mask pain that can result from lancing. In at least one embodiment, which is but one of many, and is described herein only for illustrative purposes,lance120, which can, but need not, be an off-the-shelf commercially available lance, can have a base120ahaving a dimension “D” (which can, but need not, be a diameter) of 0.250″ and alance needle120bhaving a length “l” of 0.125″.Spacer164 can have a thickness of 0.035″ and ahole170 having a dimension “d” of 0.200″. As will be understood by one of ordinary skill having the benefits of this disclosure, this illustrative embodiment, for example, can penetrate thesurface168 being lanced up to 0.090″ which is the difference between the exemplary length “l” ofneedle120aand the exemplary thickness “t” ofspacer164. As another example,surface168 can be penetrated up to 0.065″ wherespacer164 has a thickness of 0.060″ andneedle120bhas a length of 0.125″.
• The thickness “t” ofspacer164 can be any thickness required by a particular application, wherein the greater the thickness “t”, the lesser the lance penetration depth, and vice versa, for a particular length “l” of aneedle120arequired by a particular application. The thickness “t” of aparticular spacer164 can advantageously allow at least a portion ofneedle120bto penetratesurface168, such as skin or another lancing surface, so thatblood176 may leavesurface168. Exemplary thicknesses ofspacer164 can include 0.100″, 0.080″, 0.060″, 0.040″, and 0.020″, as well as thicknesses greater than, less than, or between such values.Spacer164 can be calibrated for any surface, such as for one or more areas of a user's skin. For example,spacer164 can be relatively thin for some surfaces, such as where blood vessels are scarce or more distant from the surface of the skin, orspacer164 can be relatively thick for other surfaces, for example, where blood may be closer to the skin, which can vary from application to application, or from user to user.Bottom surface174 ofspacer164 can, but need not, be in direct contact with a lancing surface, for example, for allowinghole170 to sealingly engage the surface. In at least one embodiment, for example,depth controller162 can include an annular rim (not shown), which may comprise a seal, coupled tobottom surface174 and extending downwardly to engage a lancing surface, singularly or in combination withbottom surface174.
• Depth controller162 can include interchangeable or modular units, which can includeinterchangeable spacers164 for aparticular depth controller162 or, as another example,interchangeable depth controllers162 for aparticular system100, wherein one ormore depth controllers162 can, but need not, havespacers164 of different calibrated thicknesses. Each interchangeable unit can be graduated and can, for example, vary incrementally from unit to unit. In at least one embodiment, which is but one of many,system100 can include a plurality ofdepth controllers162, such as a set or kit, which can include a plurality of different depth controllers or spacers that can be selectively changed or switched by a user as required by a particular application. In at least one embodiment, which is but one of many, a set ofdepth controllers162 may be stored, or storable, in a container, such as a bag or case, such as when not in use. A user can choose to use any of one ormore depth controllers162 required by a particular application, which can include choosing to use a depth controller already coupled todevice body102 or, as another example, can include choosing a depth controller separate fromdevice body102 and coupling the chosen depth controller todevice body102.
• FIG. 8A is an illustration of one of many embodiments of a vacuum lance system having alance tool200 according to the disclosure.FIG. 8B is an illustration of alance120 being inserted intolance coupler128 withlance tool200.FIG. 8C is an illustration of alance120 being coupled tolance coupler128 withlance tool200.FIG. 8D is an illustration of alance120 being removed fromlance coupler128 withlance tool200.FIGS. 8A-8D will be described in conjunction with one another.Vacuum lance system100 can include alance tool200 for coupling and uncoupling alance120 withlance coupling end124 of lancingshaft122, such as tolance coupler128, safely and conveniently.Lance tool200 can include alance tool body202 and one or more couplers, such as, for example,lance insertion coupler204 andlance removal coupler206, which can, but need not, be tubular. For example,insertion coupler204 andremoval coupler206 can, but need not, have annular cross-sections and/or one or more longitudinal slots to allowlance120 to be inserted therein, as will be understood by one of ordinary skill.
• To installlance120 intosystem100, for example, lance120 can be inserted intoinsertion coupler204 “needle end first” so that theneedle120boflance120 is insideinsertion coupler204 and so that base120aoflance120 couples withinsertion coupler204 and at least a portion ofbase120aprotrudes from insertion coupler204 (see, e.g.,FIG. 8B). In at least one embodiment, which is but one of many, base120aandinsertion coupler204 can form a clearance fit or, as another example, an interference fit less than an interference fit betweenlance coupler128 andbase120a.Insertion coupler204 andlance120 can be moved toward lancingend104, as indicated by the arrows inFIG. 8B, and disposed so that the portion ofbase120aprotruding frominsertion coupler204 couples withlance coupling end124 of lancingshaft122, such as to lance coupler128 (see, e.g.,FIG. 8C). For example, as mentioned above,lance base120acan form an interference fit withlance coupler128 so thatlance120 uncouples frominsertion coupler204 and remains seated inlance coupler128 for lancing whenlance tool200 is removed fromlance guide112, as indicated by the arrow inFIG. 8C.
• To removelance120 fromlance coupler128, for example,lance removal coupler206 can be inserted intolance guide112 untilremoval coupler206 passes overneedle120band couples to base120aoflance120. For example,removal coupler206 andbase120acan form an interference fit, such as an interference fit having a greater interference (i.e., a tighter fit) than the interference fit formed betweenbase120aandlance coupler128.Lance tool200 andlance120 can be moved away fromlance coupler128, as indicated by the arrows inFIG. 8D, andlance120 can uncouple fromlance coupler128 and remain coupled toremoval coupler206, which can remove lance120 fromlance coupling end124. Althoughlance insertion coupler204 andlance removal coupler206 of thelance tool200 have been described herein to communicate withlance120 using one or more “fits,” such as an interference or clearance fit, this need not be the case, and, alternatively, eachcoupler204,206 can couple withlance120 in any manner required by a particular application, as will be understood by one of ordinary skill in the art. As one example, which is but one of many,lance120 can threadably couple tolance coupler128, and one or more ofcouplers204,206 of thelance tool200 can include a notch, groove, or other structure for communicating withlance120, such as in a complementary fashion, separately or in combination with a particular fit, for example, for screwinglance120 into or unscrewinglance120 fromlance coupler128.
• In at least one embodiment oflance system100, which is but one of many,lance tool200 can be coupled tolance device body102, such as to the exterior along its length, when not in use. For example,lance device body102 orlance tool200 can, but need not, have at least oneholder208, such as complementary couplers, mounted thereon, such as, for example, magnets, hook and loop material, snaps or other fasteners. As other examples,device body102 can have a hook, brace, grip or other holder coupled thereto and adapted to holdlance tool200, such as bytool body202, ordevice body102 can have a stud or bracket adapted to couple toinsertion coupler204 orremoval coupler206.Lance tool200 can be formed from any material required by a particular application, such as plastic, metal or another material, and can be any shape or size, as will be understood by one of ordinary skill in the art having the benefits of this disclosure.
• FIG. 9 is a cross-sectional schematic view of one of many embodiments of avacuum lance system300 having anexternal vacuum indicator302 according to the disclosure. For purposes of clarity, the same reference numerals as those used previously herein will be used in some instances, while new reference numerals will be used to reference components that may not have been described above. It should be understood that although the same reference numeral may be used to reference a component in two or more Figures, the component can, but need not, be exactly the same in practice, as required by a particular embodiment or application.
• Lance system300 can generally function similarly to one or more of the other embodiments described herein, and can include anexternal vacuum indicator302 coupled todevice body102 for indicating whether a vacuum is present in the system.Indicator302 can include anindicator body304 coupled in fluid communication withvacuum chamber154, such as withindicator air tube306, which may be any type of conduit.Indicator302 can include amarker310 sealingly coupled insideindicator body304 and anindicator spring308 coupled betweenmarker310 andvacuum chamber154.Indicator302 can include aviewing window312 forviewing marker310, such as, for example, when no vacuum exists in the system.Window312 can be coupled anywhere toindicator body304, for example, to the top or side, and can be any size. For example,window312 can, but need not, be at least a portion ofindicator body304 and can be at least partially transparent, such as a thin transparent strip along the length ofindicator body304. Alternatively, for example,indicator body304 can be wholly transparent.
• Indicator302 can be coupled todevice body102 in any location between a surface being lanced andpiston148.Indicator302 can be an “L-type” indicator (as shown inFIG. 9), for example, so thatindicator body304 is parallel todevice body102, a “T-type” indicator, for example, so thatindicator body304 is perpendicular todevice body102 or, as another example,indicator302 can be disposed at another angle, which can be any angle, relative to central longitudinal axis X of the system.
• As a vacuum is created insystem300 during lancing,marker310, such as a disk or other indicator, can travel towardtube306, and, for example,spring308 can be compressed.Marker310 can, but need not, become invisible. As the vacuum is released during lancing,marker310 can move alongtube306 andspring308 can expand, which can move at least a portion ofmarker310 into view, such as being visible throughwindow312. Whileindicator spring308 can be shown to be a compression spring inFIG. 9 for illustrative purposes, it need not be, and can alternatively be a tension spring, or both, separately or in combination, as will be understood by one of ordinary skill.
• With further reference toFIG. 9,system300 can include at least one opening betweenvacuum chamber154 and an atmosphere surrounding the vacuum chamber, as described above (see, e.g.,FIG. 5A). For example, and without limitation, the embodiment ofFIG. 9, which is but one of many, can include threeopenings156A,156B and156C (collectively “opening156”), but this need not be the case and, alternatively,system300 may include any number ofopenings156, such as one, two, or more, or none, as required by a particular application. Eachopening156, such as one or more ofopenings156A-C, can be inpiston148,device body102, or another portion ofsystem300, separately or in combination. Like the embodiment ofFIG. 9, any embodiment of the present invention, such as one or more of the other embodiments shown or described herein, may include any number ofopenings156 disposed in any location required by a particular application, separately or in combination, as will be understood by one of ordinary skill having the benefits of the present disclosure. While one ormore openings156 in a particular embodiment can afford a linear vacuum dissipation rate (see, e.g.,FIG. 5H), this need not be the case and, alternatively, a rate of vacuum dissipation can be non-linear, as required by a particular application.
• FIG. 10 is a cross-sectional schematic view of one of many embodiments of avacuum lance system400 having anexternal vacuum assembly402 according to the disclosure.System400 can include a lancingassembly404 for lancing a surface, which can be any lancing assembly required by a particular application. Lancingassembly404 can, but need not, include a vacuum mechanism coupled withmain device body408, such as, for example, one or more of the embodiments described herein, partially, separately or in combination.System400 can include alance120, such as a commercially available lance, and avacuum chamber406, which can, but need not, extend at least partially insidemain device body408.System400 can include anexternal vacuum assembly402 for at least partially creating a vacuum invacuum chamber406.Vacuum assembly402 can, but need not, be a second, additional or supplementary source of vacuum insystem400, and can operate separately or in combination with one or more other components, such as vacuum components, lancing components, or other components ofsystem400.
• Vacuum assembly402 can include avacuum body410 for supporting one or more components of the system.Vacuum body410 can be tubular and can have avacuum end412 and a longitudinallyopposite end414.Vacuum body410 can, but need not, be coupled tomain device body408, rigidly, removably, or otherwise.Vacuum assembly402 can include ashaft416, which can be slideably coupled to end414.Vacuum assembly402 can include arelease mechanism418 coupled, for example, to end414 ofvacuum body410, which can cooperate withshaft416 toremovably hold shaft416 or one or more other components in one or more positions.Vacuum assembly402 can include apiston420, which can be in sealing engagement withvacuum body410, such as with aninner surface422, for example, for creating, increasing the level of, or dissipating a vacuum withinvacuum chamber406.Piston420 can, but need not, include an opening (see, e.g.,FIG. 5E) therein for allowing fluid communication betweenvacuum chamber406 and an atmosphere surroundingvacuum chamber406.Vacuum assembly402 can include one or more springs, such asspring424, for biasingpiston420 in one or more directions, for example, towardend414 ofvacuum body410.Vacuum assembly402 can be fluidicly coupled tovacuum chamber406, for example, byconduit426, which can be any conduit, such as a pipe, tube or other conduit, for routing fluid. Therefore,vacuum chamber406 can includeconduit426 and at least a portion ofvacuum body410.
• The embodiment shown inFIG. 10, which is but one of many, can generally operate or function similarly to one or more other embodiments described herein, such as to create or release a vacuum, in whole or in part, invacuum chamber406. For example,vacuum assembly402 can create at least a portion of a vacuum invacuum chamber406 and lancingassembly404 can lance a surface before, during, or after the vacuum exists.Vacuum assembly402 can, but need not, create or dissipate a vacuum in portions, such as segments or stages, for example, by movement ofpiston420 in one or more directions.Vacuum assembly402 can cooperate with lancingassembly404 to form a vacuum, in whole or in part, for example, in an embodiment, which is but one of many, wherein lancingassembly404 includes a vacuum mechanism or can otherwise be able to create at least a portion of a vacuum independent ofvacuum assembly402. Penetration of a surface can occur at any time during lancing, such as at a predetermined time during vacuum creation, as required by a particular application.
• Having described above one or more exemplary embodiments of the present invention, another one of many embodiments will now be described. For purposes of clarity, the same reference numerals as those used previously herein will be used in some instances, while new reference numerals will be used to reference components that may, but need not, differ from those described above, in whole or in part. It should be understood that although the same reference numeral may be used to reference a component in two or more of the Figures, the component can, but need not, be exactly the same in practice, as required by a particular embodiment or application, and reference numerals used herein are arbitrarily chosen for ease of explanation. One or more of the components and principles described above are also applicable to the following embodiments, and vice versa, regardless of whether like reference numerals are used, as will be readily understood by one of ordinary skill in the art. Certain details may not be repeated for purposes of brevity and the avoidance of unnecessary repetition, although such details can apply uniformly to all embodiments of the present invention.
• FIG. 11 is an isometric schematic view of another of many embodiments of a vacuum lance system according to the disclosure.FIG. 12 is an isometric assembly schematic view of the vacuum lance system ofFIG. 11.FIG. 13A is a cross-sectional schematic view of the vacuum lance system ofFIG. 11 in a cocked position.FIG. 13B is a cross-sectional schematic view of the vacuum lance system ofFIG. 11 in an uncocked position.FIG. 14 is a cross-sectional schematic view of one of many embodiments of a lancing mechanism according to the disclosure.FIG. 14A is a cross-sectional schematic view of the release mechanism ofFIG. 14 coupled to the main shaft before activation.FIG. 14B is a cross-sectional schematic view of the release mechanism ofFIG. 14A uncoupled from the main shaft after activation.FIG. 14C is a schematic view of yet another of many embodiments of a release mechanism in a deactivated position according to the disclosure.FIG. 14D is a schematic view of the release mechanism ofFIG. 14C in an activated position according to the disclosure.FIG. 14E is a schematic view of yet another of many embodiments of a release mechanism in a deactivated position according to the disclosure.FIG. 14F is a schematic view of the release mechanism ofFIG. 14E in an activated position according to the disclosure.FIGS. 11-14F will be described in conjunction with one another.
• Vacuum lance system500 can include adevice body102, which can include one ormore end caps108,110, coupled thereto or formed integrally therewith, in whole or in part. A lancingmechanism518 can be coupled tobody102, such as to lancingend104, for supporting a lance120 (also known as a “lancet”).Lancing mechanism518 can include a lancingshaft122 slideably coupled withend cap108, such as along central longitudinal axis X, for communicatinglance120 with a surface during lancing. Lancingshaft122 can include a bottomlance coupling end124 and atop actuating end126.Lancing mechanism518 can include alance coupler128 coupled to lance couplingend124 forcoupling lance120 toshaft122, removably or otherwise.Lancing mechanism518 can include one or more biasing devices, such as a lancingspring130. Lancingspring130 can be coupled to lancingshaft122 for biasingshaft122 in one or more directions, temporarily, momentarily or otherwise, as will be further described below. Lancingspring130 can, but need not, comprise a plurality of springs, and can advantageously include two springs.
• System500 can include arelease mechanism542, such as a firing assembly, which can include arelease144, one or more release couplers, and one or more components coupled there between, as further described below.Release mechanism542 can include structure for cooperating with other components ofsystem500, such aslancing mechanism518,vacuum mechanism532, or other elements of the system, separately or in combination.Release mechanism542 can be any type of releasable coupling system for lancing, and can be adapted to cooperate withmain shaft134, such as by optionally coupling withrelease coupler140,piston148, and/or other system components coupled toshaft134, to releasably holdmain shaft134 in one or more positions. In at least one embodiment,release144 can sealingly engage one or more portions of the system, such asbody102 orend cap108, which can, but need not include one ormore seals153, such as an O-ring, gasket, or other device for at least partially limiting the entrance or escape of fluid, such as into or out ofbody102 orvacuum chamber154. At least three possible embodiments ofrelease mechanism542, which are but three of many, will now be described with reference toFIGS. 14-14F for illustrative purposes.
• As one example, in the embodiment ofFIGS. 14-14B, which is but one of many,release mechanism542 can include asecond release coupler141, such as a catch or hook, for releasably coupling withcoupler140, such as a notch or groove (or vice versa) in any manner required by a particular application. The system can, but need not, include one ormore retainers143, such as a ring, washer, gasket, disk or other structure or fastener, for at least partially holdingcoupler141 in place.Release mechanism542 can include one or more biasing devices, such asspring147, for biasing at least a portion of the mechanism, such asrelease144 orcoupler141, in one or more directions, and can include one or more couplers or fasteners, such aspin149, for coupling one or more mechanism components together. For example, pin149 can couple release144 andcoupler141 for translating motion therebetween. Pin149 can pass through anopening151 instop129, such as a slot, hole, or other opening.Spring147 can bias release144 toward a deactivated position, for example, radially outwardly, and can biascoupler141, such as by biasingpin149, toward a position for coupling withmain shaft134, such as withcoupler140. In a cocked position (e.g.,FIG. 14A),couplers140,141 can be coupled and can holdpiston148 andmain shaft134 in a downward or other energized position. For example, catch141acan be disposed adjacent to wall140afor retainingpiston148 andmain shaft134, such as in a pre-firing position against theforce158aofvacuum spring158.
• With reference toFIG. 14B,release mechanism542 can be activated by movingrelease144 toward an activated position for allowingcouplers140,141 to uncouple from one another. For example, by pressingrelease144 radially inwardly (as illustrated by the vertical arrow inFIG. 14B), such as by sliding with a user's finger, or by another manner, including electronically, catch141acan move from a cocked position adjacent to wall140ato an activated position out of the way ofcoupler140, which can allowcouplers140,141 to uncouple. For example, catch141acan be moved from a pre-firing position so thatpiston148 andmain shaft134 are no longer retained against the force ofvacuum spring158, which can allowpiston148 andmain shaft134 to move toward an uncocked or deenergized position (e.g., to the right as illustrated by the horizontal arrow inFIG. 14B) asvacuum spring158 compresses or deenergizes.
• Turning toFIGS. 14C, 14D, as a second example,release144 andcoupler141 alternatively can be formed integrally as a single component and pin149 (FIG. 14A) can, but need not, be absent. In such an embodiment, which is but one of many,release144 andcoupler141 can be made at least partially from elastic material, such as one or more elastomers (e.g., rubber) or shape-memory metals, separately or in combination, and spring147 (FIG. 14A) can, but need not, be absent, as will be understood by one of ordinary skill in the art. For example, release144 can be mushroom-shaped with itshat144aadjacent the exterior ofend cap108,body102, or acoupler702 coupled thereto, such as a washer, grommet or seal, and itsstem144bextending radially inwardly towardrelease coupler141. The elasticity of the material from whichrelease144, or one or more other system components, can be at least partially formed can allow a user to at least temporarily push or otherwise deformrelease144 to activate system500 (e.g.,FIG. 14D), and can return the one or more pressed components, such asrelease144 or other components, to a default position and can return thecoupler141 to a rest position (e.g.,FIG. 14C) in a spring-like fashion. For example, as shown for exemplary purposes inFIG. 14C,release144 can biasrelease coupler141 in the upward direction (as illustrated) so that at least a portion of thecoupler141, such ascatch141a, interferes or otherwise couples withcoupler140, such as withwall140a, for cocking the system. A user can apply a deforming or activating force or pressure (such as by applying a finger) to release144, and the elastic resistance ofrelease144, which can be of any magnitude required by a particular application, can be at least partially overcome. Release144 can force or pushcatch141asome distance Δd, which can be any distance required by a particular application. Catch141acan move out of a position of interference withwall140a, which can allowpiston148 to move to the right (as illustrated) during firing of the system (FIG. 14D). Thus, as will be readily understood by one of ordinary skill in the art having the benefits of the present disclosure, the embodiment ofFIGS. 14C, 14D operates similarly to that ofFIGS. 14A, 14B, although the mechanics of one or more elastic components in the former can be substituted for those of one ormore springs147 in the latter, in whole or in part, separately or in combination.
• A third example of a release mechanism, which is but one of many in accordance with the present disclosure, is shown inFIGS. 14E-14F. In at least one embodiment,release mechanism542 can include a wishbone- or wedge-type mechanism for selectively holdingpiston148 andmain shaft134 in a cocked position. For example,release mechanism542 can include a U- or C-shapedcoupler601, such as a C-ring, circlip, snap ring or other coupler, and at least onewedge602 for defining a path of movement of at least a portion ofcoupler601, such as ends601a,601b.Wedge602 can include any structure (or structures) that can cooperate withcoupler601 as described herein, such as one or more blocks or tapers.Coupler601 can include one ormore tabs603, such as projections or other retainers, for coupling with one or more other components of the system, such asmain shaft134,piston148 orrelease coupler140.Coupler601 can expand and contract againstwedge602, which can respectively increase and decrease a distance betweentabs603 for allowingtabs603 to releasably couple and uncouple withshaft134, such as by selectively retainingrelease coupler140. In a cocked position (e.g.,FIG. 14E),tabs603 can be coupled withcoupler140, such as by being disposed adjacent thereto, and can holdpiston148 andmain shaft134 in a downward or other energized position, such as against theforce158aofvacuum spring158.Release mechanism542 can be activated by disposingcoupler601 in an activated position (e.g.,FIG. 14F), for example, by pressingrelease144 radially inwardly (as shown by the arrow inFIG. 14F for illustrative purposes), which can allow ends601a,601bto slide and spread againstwedge602, thereby at least partially separatingtabs603.Tabs603 can uncouple fromcoupler140, such as by moving radially outwardly frompiston148 orcoupler140, which can allowpiston148 andmain shaft134 to move toward an uncocked or deenergized position. Other types of release mechanisms can be coupled withsystem500, separately or in combination with one or more of those specifically described herein, in whole or in part, as will be readily understood by one of ordinary skill having the benefits of the present disclosure. For example, althoughcoupler601 is shown inFIGS. 14E-14F for illustrative purposes to expand and contract against awedge602,coupler601 could alternatively expand and contract between two or more opposing wedges or surfaces (not shown) to couple or uncouple with acorresponding release coupler140, as will be readily understood by one of ordinary skill having the benefits of this disclosure.
• System500 can include avacuum mechanism532 for creating a vacuum and cooperating with lancingmechanism518 or other components of the system during lancing.Vacuum mechanism532 can include amain shaft134 with a bottommain actuating end136 and a top mainfree end138, and at least onerelease coupler140, which can, but need not, be coupled topiston148.System500 can, but need not, include aknob146, such as a button or cap coupled to mainfree end138.Vacuum mechanism532 can include one or more pistons, such aspiston148, coupled tomain shaft134 for cooperating with one or more other components ofsystem500 to create a vacuum.Piston148 can be coupled, adjustably, fixedly or otherwise, anywhere onmain shaft134 inside ofdevice body102, such as, for example, tomain actuating end136, and can at least partially form avacuum chamber154inside device body102.System500 can include one ormore openings556, such as an air passage or orifice, for fluid communication betweenvacuum chamber154 and an atmosphere surrounding the vacuum chamber.System500 can include one or more openings between other portions of the interior ofbody102 and the atmosphere, such asopening557, for example, for allowing fluid (e.g., air) to flow in or out ofbody102 aspiston148 moves along the body's length. Opening557 can be disposed anywhere in the system, such as infree end106 of the body,cap110, or another location. Opening556 can be calibrated to allow air to flow intovacuum chamber154 at a predetermined vacuum dissipation rate, which can be any rate required by a particular application. Opening556 can be any suitable place for fluidicly communicating with a vacuum insystem500, such as indevice body102, and can advantageously be, but need not be, inrelease144. One ormore openings556 can afford any rate of vacuum dissipation required by a particular application, such as a linear rate, non-linear rate, or another rate, in whole or in part, separately or in combination.
• Vacuum mechanism532 can include a biasing device, such asvacuum spring158, coupled topiston148 for biasingpiston148 in one or more directions, such as in the upward direction towardfree end106. For example,vacuum spring158 can include a tension spring, as shown in the embodiment ofFIG. 12, which is but one of many, so that a rest position forrelease coupler140 can be towardtop end cap110.System500 can, but need not, include a vacuum indicator (such as one or more of the vacuum indicators described above; see, e.g.,FIG. 2) for indicating whether or to what extent a vacuum exists withinvacuum chamber154. For example, in an application where skin is being lanced for purposes of drawing blood, it could at times be detrimental for the user to pullsystem500 off the skin when there is still vacuum inchamber154 because inrushing air could disperse or otherwise disrupt withdrawn blood pooled on the surface. For this reason, it can be advantageous for the user to know the vacuum level inchamber154. A vacuum indicator can be calibrated to indicate whensystem500 can be removed from the skin for at least minimizing any potential that drawn blood could splatter.
• With further reference toFIGS. 12-14,system500 can include ashaft coupler160 for releasably coupling one or more components of the system, such as lancingshaft122 andmain shaft134. For example,shaft coupler160 can include afirst portion160acoupled to lancingshaft122, such as to actuatingend126, and asecond portion160bcoupled withmain shaft134, whether directly or indirectly, such as withpiston148.Lancing mechanism518 can include astop129, such as a tab, block, disk or other structure, for supporting lancingspring130 and defining a stroke of lancingshaft122, in whole or in part. For example,upper spring130acan be coupled betweenstop129 and actuatingend126, andlower spring130bcan be coupled betweenstop129 andlance coupling end124. Stop129 can be coupled withbody102, such as to endcap108, in any manner required by a particular application, which may, but need not, include the use of one ormore fasteners145, such as screws, pins, adhesives, or other holding devices, separately or in combination. Alternatively, nofasteners145 need be used, and stop129 can be coupled withbody102 in another manner, such as by force or friction fit, or can be formed integrally withcap108, in whole or in part.
• FIG. 15A is an illustration of the vacuum lance system ofFIG. 11 in a cocked position according to the disclosure.FIG. 15B is an illustration of the vacuum lance system ofFIG. 15A in one of many activated positions wherein the first and second portions of the shaft coupler are coupled according to the disclosure.FIG. 15C is an illustration of the vacuum lance system ofFIG. 15A in another of many activated positions wherein the first and second portions of the shaft coupler are uncoupled according to the disclosure.FIG. 15D is an illustration of the vacuum lance system ofFIG. 15A in another of many activated positions wherein the opening in the release is sealed according to the disclosure.FIG. 15E is an illustration of the vacuum lance system ofFIG. 15A in another of many activated positions wherein the opening in the release is not sealed according to the disclosure.FIG. 15F is an illustration of the system ofFIG. 15A in an uncocked position. At least one of many methods of using the embodiment ofsystem500 shown inFIGS. 15A-15F can be described.FIG. 15G is a graph illustrating another example of vacuum magnitude versus a time over which lancing can occur during a vacuum cycle according to the disclosure.FIGS. 15A-15G will be described in conjunction with one another.
• Alance120 can be coupled to lancingmechanism518, such as by using one of the methods described herein, for example, before or aftersystem500 is in a “cocked” position (see, e.g.,FIG. 15A). A lance guide, such asdepth controller162, can be coupled to lancingend104, such as withend cap108.System500 can be cocked, for example, by pressingknob146 downward untilrelease coupler140 couples withrelease mechanism142, such as by releasably engagingcoupler141. First andsecond portions160a,160bofshaft coupler160 can couple together to releasably couple the actuating ends ofshafts122,134. Actuatingend126 can, but need not, move downwardly during cocking, temporarily or otherwise.Upper spring130aandlower spring130bcan, but need not, be in their natural states.System500 can contact a surface to be lanced (not shown), such as an area of skin on a person's body, which can be any area, and can advantageously form an at least partially airtight seal betweendepth controller162, or a portion thereof, such asseal116, and the surface.Seal116 can be formed integrally with depth controller162 (as shown for illustrative purposes) or can be a separate structure coupled todepth controller162, separately or in combination.
• A user can place his or her finger onrelease144 in preparation for firing the system andopening556 can advantageously be at least temporarily closed, for example, to at least substantially sealvacuum chamber154 amongbody102,piston148 and the surface to be lanced. As shown in the embodiment ofFIGS. 15A-15F, which is but one of many, opening556 can advantageously be disposed throughrelease144, for example, so that a user can simultaneously block, plug or otherwise obstruct opening556 upon engagingrelease144 with a finger or other actuator (such as a glove or other object). However, this need not be the case, and, alternatively or collectively, opening556 can be located elsewhere, such as throughbody102 orcap108, and a user may close the opening(s) in another manner, such as by using another finger. As another example,system500 can include a valve (not shown), such as a ball valve, needle valve, or other device for regulating or directing fluid flow, for electively starting, stopping or otherwise controlling flow through one or more openings, such asopening556.
• As indicated by the arrows inFIGS. 15B-15C,system500 can be activated by actuating (e.g., pressing inwardly)release144, which can coupler140 andcoupler141 to disengage or otherwise uncouple.Vacuum spring158 can at least partially contract andpiston148,main shaft134 andshaft coupler160 can move in the upward direction away from the surface being lanced.Piston148 can at least partially form a vacuum invacuum chamber154 aspiston148 moves away from the surface being lanced, andopening556 can remain closed, for example, to sustain the sealed chamber. One or more components of lancingmechanism118, such as actuatingend126 and lancingshaft122 can move upward withmain shaft134, for example, due to the coupling force ofshaft coupler160 and the force of contractingvacuum spring158.Upper spring130acan expand andlower spring130bcan contract, which can, for example, singularly or in combination, exert an increasing force onfirst portion160aofshaft coupler160 in an opposite direction (e.g., downward) from a force exerted onsecond portion160bby vacuum spring158 (e.g., upward) asvacuum spring158 contracts (FIG. 15B). Lancingshaft122 can contact stop129, which can limit a stroke of lancingshaft122.
• Shaft coupler160 can uncouple andsecond portion160bcan continue moving in an upward direction (as illustrated in the FIGS. for illustrative purposes) whilefirst portion160aand lancingshaft122 reverse and move in an opposite (e.g., downward) direction toward the surface to be lanced (FIG. 15C).Lance120 can penetrate the surface and lancingmechanism518 can return to a state of rest.Piston148 can continue moving upwardly at least partially towardfree end106. Aspiston148 moves towardfree end106, such as under the force ofspring158, a magnitude of vacuum formed invacuum chamber154 can gradually increase andopening556 can remain closed (FIG. 15D). The vacuum can generate a force acting onpiston148 in a direction opposite a force of spring158 (e.g., downwardly), and the magnitude of the vacuum force can eventually become greater than or equal to that of the spring force, for example, so thatpiston148 can at least partially come to rest between its cocked and uncocked positions (FIG. 15E) along the length ofbody102, which may occur anywhere along the length of the body or stoke ofshaft134 as required by a particular application.
• At this point in the exemplary vacuum assisted lancing process, the magnitude of the vacuum can, but need not, be at least substantially constant, and the vacuum can act on the lanced surface, which can advantageously result in suction that at least partially draws, or helps draw, blood from the surface. The user can maintain the state of vacuum invacuum chamber154 by keepingopening556 closed, for example, by keeping his or her finger sealingly disposed there against, which can, but need not, include holdingrelease144 at least partially in an actuated position (e.g., inwardly, as indicated by the arrow inFIG. 15E). The user can view the area in which the surface has been pierced, such as throughviewing area114, which can, but need not, be at least a portion of a lance guide (see, e.g.,FIG. 1) or adepth controller162, and can advantageously verify whether or when a desired amount of blood, such as enough blood for testing, has exited from the surface. Although the Applicant expects that a requisite or desired amount of blood will often be recognized by a user through experience in lancing and blood extraction, this need not be the case, and a volume of extracted blood can be quantified by other measures. For example, in at least one embodiment of the system,hole170 can be sized or calibrated, such as through one or more dimensions, to contain a minimum volume of extracted blood required by a particular application.
• In these manners, it will be apparent that a user can advantageously maintain the vacuum on the surface until a desired amount of blood is extracted, and, for example, can thereafter electively commence dissipation of the vacuum by opening or unblocking one ormore openings556, such as by removing his or her finger fromrelease144 and opening556 (e.g., as indicated by the vertical arrow inFIG. 15F). Unblockingopening556 can allow air to flow intovacuum chamber154, andpiston148 can resume travel (e.g., as indicated by the horizontal arrow inFIG. 15F) towardfree end106 until, for example,vacuum mechanism532 comes to rest in an uncocked position (FIG. 15F). The vacuum can be dissipated at any rate required by a particular application, and can advantageously be dissipated at a relatively rapid rate by unblocking the opening as soon as the user observes or verifies that a sufficient amount of blood, such as an amount adequate for testing, has been extracted. Such an advantage can at least partially minimize the amount of time over which the system contacts the skin while at the same time providing the user with a readily attainable indication that the elapsed time and vacuum magnitude have been sufficient for drawing a required amount of blood for the purpose of a particular application. At the user's option, such as can be determined from the user's visual feedback,system500 can be disengaged from the surface, which can leave a quantity of blood in a pool on the surface for collection.
• As explained above with reference to one or more other embodiments of the present invention, the surface can be subjected to a vacuum before, during, or after lancing, separately or in combination. Air can enter or leavevacuum chamber154 andbody102 at any rate required by a particular application. A surface being lanced can, but need not, be manipulated during lancing, which can include twisting, pumping, pressing up and down, or any movement, separately or in combination (see, e.g.,FIG. 5F). With continuing reference toFIGS. 15A-15F, and further reference toFIG. 15G, the timing and magnitude of vacuum creation and lancing can include one or more variables, as will be understood by one of ordinary skill, each of which can have any value required by a particular application. For example, the magnitude of the vacuum, the rate at which the vacuum can be created, the timing of lancing, such as whenshaft coupler160 uncouples, the rate at whichlance120 can travel, and the force with whichlance120 strikes a surface, or other factors, can be optimized for a particular application. Vacuum creation can occur in a single stage, or in multiple stages.
• As shown for illustrative purposes inFIG. 15G, lancing of a surface can occur at any time before, during, or after a vacuum cycle, as may be suitable for a particular application. For example, lancing of the surface can occur before a vacuum is created, as indicated by reference A. Alternatively, lancing can occur while the vacuum is increasing in the device body, as indicated by reference B. As will be understood by one of ordinary skill having the benefits of this disclosure, reference B illustrates one of many lancing times during vacuum creation, and lancing can alternatively occur at any point along a line between references A and C. As another example, lancing can occur when the vacuum is at peak vacuum P, illustrated by reference C. In at least one embodiment of the present invention, such as, for example, the embodiment shown and described inFIGS. 15A-15F, the magnitude of vacuum, such as peak vacuum P, can be maintained for a period of vacuum holding time after lancing has occurred, as indicated by line CD. A holding time can be any period of time required by a particular application or otherwise chosen by a user, such as an amount of time sufficient to allow a desired amount of blood to exit the surface. A user can allow the vacuum to dissipate, in whole or in part, or can commence dissipation of the vacuum, at a timing of their choosing, for example, through manipulation ofopening556. Vacuum dissipation can occur at any rate required by a particular application, as indicated for illustrative purposes by the slope of line DE, such as until the vacuum has fully dissipated, as illustrated by reference E inFIG. 15G.
• As described above, lancing can occur at any time during a vacuum cycle, including before, during, or after a vacuum is created, and can advantageously occur when at least a partial vacuum is created, such as between 30% and 70%, or any increment there between, of the maximum vacuum for a particular application. In at least one embodiment, which is but one of many, lancing can advantageously occur at between 40% and 60% of vacuum creation, or any increment there between, such as at 50% vacuum creation. For example, the maximum vacuum can be −20 inHg, and the surface can be lanced when the vacuum invacuum chamber154 is, for example, −10 inHg. However, this need not be the case, and the examples described herein are for illustrative purposes. The timing of lancing can, but need not, be adjustable. For example, in at least one embodiment, such as a commercial embodiment, which is but one of many,system500 can include a plurality of interchangeable lancing shafts, each of which can have a different length, which can determine when lancing occurs during a vacuum cycle, as described above.
• FIG. 16 is an isometric schematic view of yet another of many embodiments of avacuum lance system500 according to the disclosure.FIG. 17 is an isometric assembly schematic view of thevacuum lance system500 ofFIG. 16.FIGS. 16-17 will be described in conjunction with one another.FIGS. 16-17 illustrate yet another of many embodiments ofsystem500, which can include alancing mechanism518,vacuum mechanism532, andrelease mechanism542, such as one or more of those described herein, separately or in combination, in whole or in part. This embodiment can generally function similarly to one or more of the other system embodiments described herein, as will be understood by a person of ordinary skill in the art having the benefits of the present disclosure, and like features and methods may not be described again here in order to avoid repetition.
• As with one or more of the other embodiments shown and described in the present disclosure, thevacuum lance system500 ofFIGS. 16-17 can include adevice body102, which can include one ormore end caps108,110, coupled thereto or formed integrally therewith, in whole or in part.Body102 can, but need not, be at least partially curved or contoured, such as on its exterior, for providing a comfortable, ergonomic, or user-friendly grip as required by a particular application. A lancingmechanism518 can be coupled tobody102, such as to lancingend104, for supporting a lance120 (also known as a “lancet”).Lancing mechanism518 can include a lancingshaft122 slideably coupled withend cap108, such as along central longitudinal axis X, for communicatinglance120 with a surface during lancing. Lancingshaft122 can include a bottomlance coupling end124 and atop actuating end126.Lancing mechanism518 can include alance coupler128 coupled to lance couplingend124 forcoupling lance120 toshaft122, removably or otherwise.Lancing mechanism518 can include one or more biasing devices, such as lancing springs130a,130b(collectively referred to as lancing spring130). Lancingspring130 can be coupled to lancingshaft122 for biasingshaft122 in one or more directions, temporarily, momentarily or otherwise, as further described above.
• System500 can include arelease mechanism542, such as a firing assembly, which can include arelease144, one or more release couplers, and one or more components coupled there between. As shown for exemplary purposes inFIGS. 16-17,system500 can advantageously include the embodiment ofrelease mechanism542 shown inFIGS. 14C, 14D and described above, separately or in combination with one or more of the other exemplary release mechanisms described herein, in whole or in part.Release mechanism542 can include structure for cooperating with other components ofsystem500, such aslancing mechanism518,vacuum mechanism532, or other elements of the system, separately or in combination. For example,release mechanism542 can be adapted to cooperate withmain shaft134, such as by including one ormore release couplers141, for example, to optionally couple withrelease coupler140,piston148, and/or other system components coupled toshaft134, to releasably holdmain shaft134 in one or more positions. In at least one embodiment,release144 can sealingly engage one or more portions of the system, such asbody102 orend cap108, which can, but need not include one ormore couplers702, such as an O-ring, gasket, washer, seal or other device for at least partially limiting the entrance or escape of fluid, such as into or out ofbody102 orvacuum chamber154.System500 can include one or more shaft couplers, which can include one or more portions, such asfirst portion160aandsecond portion160b, for at least temporarily coupling together lancingshaft122 andmain shaft134.Shaft coupler160, or a portion thereof, can be coupled to another component of the system, such as one of shafts,122,134, in any manner required by a particular application, which can, but need not, include use of one ormore fasteners704, such as a pin, screw, bolt, shaft, adhesive, or other fastener, separately or in combination.System500 can include aknob146 for cocking the system, which can, but need not, include two or more portions coupled to one another, such asfirst portion146a,second portion146band top end cap110 (collectively referred to as knob146). As is also shown and described above (see, e.g.,FIGS. 11-14D),vacuum mechanism532 can include one or more components for creating a vacuum inchamber154, such as one or more vacuum springs158 andpistons148, which can, but need not, include one or more O-rings150.
• With continuing reference toFIGS. 16-17,system500 can include one ormore depth controllers162, which advantageously can be at least partially formed from transparent material, for example, to include aviewing area114, in whole or in part.Depth controller162 can include interchangeable or modular units, which can includeinterchangeable spacers164 for aparticular depth controller162. As another example,system500 can include a plurality of interchangeable depth controllers, such as, for example,depth controller162 and one, two, three or morealternative depth controllers162. In either case, eachinterchangeable spacer164 can, but need not, have a different calibrated length, such as lengths L1, L2 and L3, which can include any length required by a particular application. As another example,depth controller162 can be adjustable, such as by way of one or more variable components, for example, aspacer164 of varying length or thickness, as will be further described below. Typically, although not necessarily, the length of eachspacer164 can be less than the length of aparticular lance needle120bto be used with the spacer. Each interchangeable unit can be graduated and can, for example, vary incrementally from unit to unit. In at least one embodiment, such as a commercial embodiment,system500 can include and be sold with a plurality of depth controllers as a set or kit. A user can choose to use any of one ormore depth controllers162 required by a particular application, which can include choosing to use a depth controller already coupled todevice body102 or, as another example, can include choosing a depth controller separate fromdevice body102 and coupling the chosen depth controller todevice body102. Similarly,system500, or any set or kit including one or more components ofsystem500, can include a plurality of interchangeable biasing devices, such as one or more interchangeable lancing springs130a,130bor vacuum springs158 for altering one or more lancing characteristics of the system. For example, each interchangeable biasing device can have one or more unique characteristics, such as dimensional, material, or elasticity characteristics (e.g., spring constant). A particular biasing device, or combination of biasing devices, can be chosen and implemented as required by a particular application based on one or more application-specific factors, such as the material or surface to be lanced, the depth of lancing, required lancing or vacuum forces, or other factors, as will be readily understood by one of ordinary skill having the benefits of Applicant's disclosure.
• FIG. 18 is a schematic view of one of many embodiments of avacuum lance system500 having anadjustable depth controller162 in a first position according to the disclosure.FIG. 19 is a schematic view of thesystem500 ofFIG. 18 with theadjustable depth controller162 in a second position.FIGS. 18 and 19 will be described in conjunction with one another. As described above,vacuum lance system500 can include one ormore depth controllers162 for controlling the depth of lancing, which can include one ormore spacers164 that can be interchanged, such as individually or by way of interchangeable depth controllers162 (see, e.g.,FIG. 17). The general structure and function of one ormore depth controllers162 in accordance with the present invention have been described above, for example, with respect toFIGS. 6-7C, and need not be fully repeated. Turning to yet another of many embodiments ofdepth controller162,system500 can include anadjustable depth controller162 for controlling the depth of lance penetration, which can, but need not, take the place of one or more of a plurality of interchangeable depth controllers or spacers, and which can alternatively be used in conjunction therewith, in whole or in part. As shown inFIGS. 18-19,depth controller162 can include adjustable structure, which can be any structure required by a particular application, for varying the thickness ofspacer164 over a range of values, such as between a thickness for minimum penetration ofsurface168 bylance needle120b, including no penetration, and a thickness for maximum penetration ofsurface168. As described above, base120acan contact an upper surface ofspacer164 during lancing, which can limit the depth to which needle120bcan penetratesurface168, such as to the difference between length “l” ofneedle120band the thickness “t” ofspacer164. As will be understood by one of ordinary skill in the art having the benefits of Applicant's disclosure, the value of thickness “t” can be maximized in order to minimize, or even prevent, the depth of lance penetration, and the value of thickness “t” can be minimized in order to maximize the depth of lance penetration. For example,depth controller162 can have a “safety” setting wherein the value of thickness “t” can be greater than or equal to the value of length “l” ofneedle120b, thereby preventingneedle120bfrom protruding beyondspacer164 when not intended, such as during storage, travel or periods of non-use.
• With continuing reference toFIGS. 18-19, one of many embodiments of anadjustable depth controller162 can include anadjustable spacer164 for varying thickness “t”. For example,spacer164 can include one ormore blocks180a,180b(collectively referred to herein as blocks180), such as shims, wedges, disks, or other structure, for at least temporarily defining the adjustable thickness “t” ofspacer164. For example, at least one of the blocks, such astopmost block180a, can be moveable, for example by rotating, sliding or other motion, separately or in combination, to change the relative positions of the blocks, thereby increasing or decreasing the overall thickness “t” ofspacer164, such as by changing the distance betweensurfaces181,183 of the blocks. Alternatively, both blocks180 can, but need not, be moveable. Blocks180 can, but need not, be coupled to one another, and a moveable block can cooperate withdepth controller162 in any manner required by a particular application, for example, by translating along a groove or other path, by friction fit or by rotating about or along a guide structure, separately or in combination. In at least one embodiment of a lancing system having anadjustable depth controller162, which is but one of many, one or more blocks180 can have acoupler182 for manipulating the one or more blocks to adjust the thickness ofspacer164.Coupler182 can be any type of coupler required by a particular application, such as an opening, a protrusion, a threaded, grooved, notched or otherwise keyed hole (partial or thru), or other structure. Alternatively,coupler182 can be absent.Coupler182 can, but need not, be adapted to couple or otherwise cooperate with one ormore actuators184 for moving one or more blocks180 between one or more positions to at least temporarily define or “set” the thickness ofspacer164.Actuator184 can be any type of actuator required by a particular application, such as a rod, lever or other structure, and can be coupled tocoupler182 temporarily, permanently, or otherwise, including being formed integrally therewith, in whole or in part. As another example,actuator184 can be a user-supplied actuator, such as a user's fingertip or another device for moving a block180, for example, a bobby pin, toothpick, the head of a pen or pencil, or another device. As will be readily understood by one of ordinary skill having the benefits of Applicant's disclosure,adjustable depth controller162 orspacer164 can be adjustable in any one or more of many conventional manners of adjustment, separately or in combination, and the adjustable components ofsystem500 shown inFIGS. 18-19 are but a few of many possibilities. For example,adjustable depth controller162 can have a spacer of fixed dimension, and the distance between the spacer and the system body can be adjustable, such as by way of sliding, threaded, or otherwise moveable features. As will also be understood by one of skill in the art, althoughadjustable depth controller162 is described herein with reference tosystem500 for illustrative purposes, the characteristics and components of these elements apply equally to all other lancing systems described herein, separately or in combination, specifically including, without limitation,systems100,300 and400 described with reference toFIGS. 1-10.
• Other and further embodiments utilizing one or more aspects of the invention described above can be devised without departing from the spirit of Applicant's invention. Further, the various methods and embodiments of the lancing system can be included in combination with each other to produce variations of the disclosed methods and embodiments. For example, unless the context requires otherwise, all of the elements and methods described with reference to the embodiments ofFIGS. 1-10 apply equally to the embodiments ofFIGS. 11-19, and vice-versa. Discussion of singular elements can include plural elements and vice-versa. References to at least one item followed by a reference to the item may include one or more items. Also, various aspects of the embodiments could be used in conjunction with each other to accomplish the understood goals of the disclosure. Unless the context requires otherwise, the word “comprise” or variations such as “comprises” or “comprising,” should be understood to imply the inclusion of at least the stated element or step or group of elements or steps or equivalents thereof, and not the exclusion of a greater numerical quantity or any other element or step or group of elements or steps or equivalents thereof. The device or system may be used in a number of directions and orientations. The order of steps can occur in a variety of sequences unless otherwise specifically limited. The various steps described herein can be combined with other steps, interlineated with the stated steps, and/or split into multiple steps. Similarly, elements have been described functionally and can be embodied as separate components or can be combined into components having multiple functions.
• The invention has been described in the context of preferred and other embodiments and not every embodiment of the invention has been described. Obvious modifications and alterations to the described embodiments are available to those of ordinary skill in the art. The disclosed and undisclosed embodiments are not intended to limit or restrict the scope or applicability of the invention conceived of by the Applicant, but rather, in conformity with the patent laws, Applicant intends to fully protect all such modifications and improvements that come within the scope or range of equivalent of the following claims.

Claims (21)

1-20. (canceled)

21. A vacuum assisted lancing system for blood extraction, comprising:

a tubular body having a central longitudinal axis;

a lancing end;

a free end longitudinally opposite the lancing end;

a lancing mechanism coupled with the body and configured to removably couple with a lance;

a vacuum mechanism coupled with the body and including a piston slideably coupled within the body;

a vacuum chamber between the piston and the lancing end;

a release mechanism configured to selectively hold the vacuum mechanism in an energized state; and

an opening between the piston and the lancing end that allows air to flow into the vacuum chamber from an atmosphere surrounding the system.

22. The lancing system ofclaim 21, wherein the opening is configured to be sealingly engaged by a user's fingertip for selectively blocking and unblocking the opening.

23. The lancing system ofclaim 21, wherein the release mechanism comprises a release and wherein the opening is disposed in the release.

24. The lancing system ofclaim 23, wherein the opening is configured to be at least partially blocked when the release is in an activated position.

25. The lancing system ofclaim 21, further comprising a valve coupled to the opening.

26. The lancing system ofclaim 21, further comprising a tubular lance guide having one end removably coupled to the body and a longitudinally opposite end configured to sealingly engage a surface to be lanced, the lance guide being at least partially transparent.

27. The lancing system ofclaim 21, further comprising a depth controller having one end removably coupled to the lancing end and a longitudinally opposite end configured to sealingly engage a surface to be lanced.

28. The lancing system ofclaim 27, wherein the depth controller is adjustable.

29. The lancing system ofclaim 27, wherein the depth controller further comprises a spacer having a variable thickness.

30. The lancing system ofclaim 21, further comprising a lance coupled to the lancing mechanism.

31. A vacuum assisted lancing system for blood extraction, comprising:

a body having a first end adapted to sealingly engage a surface to be lanced, a longitudinally opposite second end, and a vacuum chamber between the first and second ends;

means for creating a vacuum in the vacuum chamber and acting on the surface;

means for disposing a lance in contact with the surface while the vacuum is acting on the surface; and

an opening through a side of the body and that allows air to flow into the vacuum chamber from an atmosphere surrounding the body.

32. The lancing system ofclaim 31, wherein the opening is disposed through a release.

33. The lancing system ofclaim 31, further comprising means for simultaneously initiating creation of the vacuum and at least partially preventing airflow through the opening.

34. The lancing system ofclaim 31, further comprising means for dissipating the vacuum at a controlled rate.

35. The lancing system ofclaim 31, further comprising a lance coupled to the means for disposing a lance in contact with the surface.

36. A method of manipulating a surface for blood extraction with a vacuum assisted lancing system including a tubular body, a lancing mechanism coupled with the body and having a lance coupler configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a vacuum chamber between the piston and a lancing end of the body, a release mechanism configured to selectively hold the vacuum mechanism in an energized state, and an opening between the piston and the lancing end that allows air to flow into the vacuum chamber from an atmosphere surrounding the lancing system, the method comprising:

coupling the lancing system to the surface;

blocking the opening;

activating the lancing system, thereby creating a vacuum, subjecting the surface to the vacuum, and moving the lance coupler from a first position distal from the surface to a second position proximal to the surface;

maintaining the vacuum for a period of time; and

commencing dissipation of the vacuum by unblocking the opening, thereby allowing airflow into the vacuum chamber from the atmosphere surrounding the lancing system while the lancing system is coupled to the surface.

37. The method ofclaim 36, wherein the opening is disposed through a release, and wherein the blocking and activating steps are accomplished simultaneously by engaging and holding the release.

38. The method ofclaim 37, wherein commencing dissipation of the vacuum further comprises disengaging the release.

39. The method ofclaim 36, wherein blocking the opening further comprises sealingly engaging the opening with a finger, and wherein unblocking the opening further comprises disengaging the opening and the finger.

40. The method ofclaim 36, wherein the lancing system includes a lance removably coupled to the lance coupler, and wherein the method further comprises lancing the surface.

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