US20200155736A1 - Systems and methods for treating a tissue site with reduced pressure involving a reduced-pressure interface having a cutting element - Google Patents

Abstract

Systems and methods for a reduced-pressure interface for providing reduced pressure through a sealing member to a distribution manifold includes a housing having a flange portion and a cavity wall portion such that the cavity wall portion forms a cavity having a tissue-facing cavity opening. A conduit port is coupled to the cavity wall and has a conduit aperture, such that the conduit port is adapted to receive a reduced-pressure delivery conduit. An attachment device is coupled to a tissue-facing side of the flange portion of the housing such that the attachment device couples the housing to the sealing member. Additionally, a cutting element is at least temporarily coupled to the housing proximate to the tissue-facing cavity opening such that the cutting element is adapted to form an aperture in the sealing member when the cutting element is driven into the sealing member with a driving force.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 15/842,274, filed Dec. 14, 2017, which is a continuation of U.S. patent application Ser. No. 14/276,853, filed May 13, 2014, now U.S. Pat. No. 9,878,077, which is a continuation of U.S. patent application Ser. No. 13/554,620, filed Jul. 20, 2012, now U.S. Pat. No. 8,758,328, which claims the benefit, under 35 USC § 119(e), of the filing of U.S. Provisional Patent Application Ser. No. 61/511,840, entitled “Systems and Methods for Treating a Tissue Site with Reduced Pressure Involving a Reduced-Pressure Interface having a Cutting Element,” filed Jul. 26, 2011, and U.S. Provisional Patent Application Ser. No. 61/511,827, entitled “Systems and Methods for Treating a Tissue Site with Reduced Pressure Involving a Reduced-Pressure Interface having a Multi-Lumen Conduit for Contacting a Manifold,” filed Jul. 26, 2011, which is incorporated herein by reference for all purposes.
BACKGROUND
• The present disclosure relates generally to medical treatment systems and, more particularly, but not by way of limitation, to systems, methods, and apparatuses for treating a tissue site with reduced pressure involving a reduced-pressure interface having a cutting element.
• Clinical studies and practice have shown that providing a reduced pressure in proximity to a tissue site augments and accelerates the growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but application of reduced pressure has been particularly successful in treating wounds. This treatment (frequently referred to in the medical community as “negative pressure wound therapy,” “reduced pressure therapy,” or “vacuum therapy”) provides a number of benefits, which may include faster healing and increased formulation of granulation tissue. Typically, reduced pressure is applied to tissue through a manifold device. The porous pad contains cells or pores distributes reduced pressure to the tissue and channel fluids that are drawn from the tissue.
SUMMARY
• According to an illustrative embodiment a reduced-pressure interface for providing reduced pressure through a sealing member to a distribution manifold includes a housing having a flange portion and a cavity wall portion such that the cavity wall portion forms a cavity having a tissue-facing cavity opening. A conduit port is coupled to the cavity wall and has a conduit aperture, such that the conduit port is adapted to receive a reduced-pressure delivery conduit. An attachment device is coupled to a tissue-facing side of the flange portion of the housing such that the attachment device couples the housing to the sealing member. Additionally, a cutting element is at least temporarily coupled to the housing proximate to the tissue-facing cavity opening such that the cutting element is adapted to form an aperture in the sealing member when the cutting element is driven into the sealing member with a driving force.
• According to another illustrative embodiment a system for treating a tissue site on a patient with reduced pressure includes a distribution manifold for placing proximate to the tissue site, a sealing member for covering the distribution manifold and a portion of intact epidermis of the patient to form a sealed space, a reduced-pressure interface for providing reduced pressure through the sealing member to the distribution manifold, a reduced-pressure source, and a reduced-pressure delivery conduit for fluidly coupling the reduced-pressure source to the reduced-pressure interface. The reduced-pressure interface includes a housing having a flange portion and a cavity wall portion such that the cavity wall portion forms a cavity having a tissue-facing cavity opening, a conduit port coupled to the cavity wall and having a conduit aperture such that the conduit port is adapted to receive the reduced-pressure delivery conduit, an attachment device coupled to a tissue-facing side of the flange portion of the housing such that the attachment device couples the housing to the sealing member, and a cutting element at least temporarily coupled to the housing proximate to the tissue-facing cavity opening. The cutting element is adapted to form an aperture in the sealing member when the cutting element is driven into the sealing member with a driving force.
• According to another illustrative embodiment a method for treating a tissue site on a patient with reduced pressure includes disposing a distribution manifold proximate to the tissue site and covering the distribution manifold and a portion of intact epidermis of the patient with a sealing member to form a sealed space in which the distribution manifold is disposed. The sealing member has a first side and a second, tissue-facing side. The method further includes providing a reduced-pressure source, coupling a reduced-pressure interface proximate to the first side of the sealing member, and fluidly coupling a reduced-pressure delivery conduit between the reduced pressure source and the reduced-pressure interface. The reduced-pressure interface includes a housing having a wall portion such that the wall portion forms a cavity having a tissue-facing cavity opening, a conduit port coupled to the cavity wall for receiving the reduced-pressure delivery conduit, an attachment device for coupling the reduced-pressure interface to the sealing member, and a cutting element at least temporarily coupled to the housing proximate to the tissue-facing cavity opening such that the cutting element is adapted to perforate the sealing member when the cutting element is driven into the sealing member with a driving force. The method also includes applying a driving force to the reduced-pressure interface of sufficient strength to cause the cutting element to perforate the sealing member.
• According to yet another illustrative embodiment, an interface for providing reduced pressure through a drape to a manifold includes a housing having a flange portion and a cavity wall portion. The cavity wall portion forms a cavity and a cavity wall aperture is formed within the cavity wall portion for receiving a tube. The interface further includes a coupler positioned on a tissue-facing side of the flange portion of the housing for attaching the housing to the drape and a protrusion coupled to the housing proximate to the flange portion. The protrusion extends beyond the tissue-facing side of the flange portion of the housing and is configured to form an aperture in the drape when the protrusion is driven into the drape with the reduced pressure.
• According to another illustrative embodiment, a system for treating a wound with reduced pressure includes a manifold for positioning adjacent the wound, a drape for covering the manifold and a portion of intact epidermis of the patient to form a sealed space, a reduced-pressure interface for providing reduced pressure through the drape to the manifold, a reduced-pressure source, and a conduit for fluidly coupling the reduced-pressure source to the reduced-pressure interface. The reduced-pressure interface includes a housing having a flange portion and a cavity wall portion. The cavity wall portion forms a cavity and a cavity wall aperture is formed within the cavity wall portion for receiving a tube. The reduced-pressure interface further includes a coupler positioned on a tissue-facing side of the flange portion of the housing for attaching the housing to the drape and a protrusion coupled to the housing proximate to the flange portion. The protrusion extends beyond the tissue-facing side of the flange portion of the housing and is configured to form an aperture in the drape when the protrusion is driven into the drape with the reduced pressure.
• In another illustrative embodiment, a method for treating a wound on a patient with reduced pressure includes disposing a manifold proximate to the wound, covering the manifold and a portion of intact epidermis of the patient with a drape to form a sealed space in which the manifold is disposed. The drape has a first side and a second, tissue-facing side. The method further includes providing a reduced-pressure source, coupling a reduced-pressure interface proximate to the first side of the drape, and fluidly coupling a tube between the reduced-pressure source and the reduced-pressure interface. The reduced-pressure interface includes a housing having a flange portion and a cavity wall portion. The cavity wall portion forms a cavity and a cavity wall aperture is formed within the cavity wall portion for receiving a tube. The reduced-pressure interface further includes a coupler positioned on a tissue-facing side of the flange portion of the housing for attaching the housing to the drape and a protrusion coupled to the housing proximate to the flange portion. The protrusion extends beyond the tissue-facing side of the flange portion of the housing and is configured to form an aperture in the drape when the protrusion is driven into the drape with a driving force. The method further includes applying the driving force to the reduced-pressure interface of sufficient strength to cause the protrusion to perforate the drape.
• Other features and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic perspective view of an illustrative embodiment of a system for treating a tissue site with reduced pressure;
• FIG. 2 is a schematic, cross-sectional view of an illustrative embodiment of a multi-lumen conduit of the system shown inFIG. 1 taken along line2-2;
• FIG. 3 is a schematic, cross-sectional view of one illustrative embodiment of a reduced-pressure interface having a cutting element for use as part of a system for treating a tissue site with reduced pressure;
• FIG. 4 is a schematic, bottom view of the reduced-pressure interface ofFIG. 3;
• FIG. 5A is a schematic, cross-sectional view of the reduced-pressure interface ofFIG. 3 under reduced pressure prior to the cutting element perforating a sealing member;
• FIG. 5B is another schematic, cross-sectional view of the reduced-pressure interface ofFIG. 3 under reduced pressure after the cutting member has perforated the sealing member;
• FIG. 5C is another schematic, cross-sectional view of the reduced-pressure interface ofFIG. 3 under reduced pressure after the cutting member has perforated the sealing member and the cutting element has been removed;
• FIG. 6 is a schematic, top perspective view of another illustrative embodiment of a reduced-pressure interface having a cutting element for use as part of a system for treating a tissue site with reduced pressure;
• FIG. 7 is a schematic, cross-sectional view of the reduced-pressure interface ofFIG. 6;
• FIG. 8 is a schematic, bottom perspective view of a portion of the reduced-pressure interface ofFIG. 6;
• FIG. 9A is a schematic, cross-sectional view of the reduced-pressure interface ofFIGS. 6-8 being applied and prior to reduced pressure being supplied;
• FIG. 9B is a schematic, cross-sectional view of the reduced-pressure interface ofFIGS. 6-8 under reduced pressure prior to the cutting element perforating a sealing member;
• FIG. 9C is a schematic, cross-sectional view of the reduced-pressure interface ofFIGS. 6-8 under reduced pressure after the cutting member has perforated the sealing member and the cutting element has been removed; and
• FIG. 10 is a schematic diagram of a representative pressure set-up pattern.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
• In the following detailed description of the illustrative embodiments, reference is made to the accompanying drawings that form a part hereof. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the embodiments described herein, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the illustrative embodiments are defined only by the appended claims. Unless otherwise indicated, as used herein, “or” does not require mutual exclusivity.
• The term “reduced pressure” as used herein generally refers to a pressure less than the ambient pressure at a tissue site that is being subjected to treatment. In most cases, this reduced pressure will be less than the atmospheric pressure at which the patient is located. Alternatively, the reduced pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in reduced pressure typically refer to a decrease in absolute pressure, and decreases in reduced pressure typically refer to an increase in absolute pressure.
• Referring now to the drawings and initially toFIGS. 1-5C, and specifically toFIGS. 1 and 3, asystem100 for treating atissue site102 on apatient104 with reduced pressure is presented. Thesystem100 includes a reduced-pressure dressing106 for disposing proximate thetissue site102. Thesystem100 also includes a reduced-pressure treatment unit108 fluidly connected to the reduced-pressure dressing106 through a reduced-pressure delivery conduit110 for applying reduced pressure to thetissue site102. The reduced-pressure dressing106 may further include adistribution manifold112, a sealingmember114, and a reduced-pressure interface116. The reduced-pressure interface116 includes acutting element118 adapted to form an aperture120 (seeFIG. 5B) in the sealingmember114. Including the cuttingelement118 on the reduced-pressure interface116 provides a number of potential benefits. The benefits may include ease of application and the reduction of error when forming theaperture120. In a non-limiting example, errors in (1) positioning theaperture120 on the dressing, (2) sizing of theaperture120, and (3) the formation of theaperture120 may be reduced. Incorrectly forming theaperture120 may leave portions of the sealingmember114 in a position that can block theaperture120 when reduced pressure is applied.
• Thesystem100 may be used with various different types oftissue sites102. Thetissue site102 may be awound122 or wound cavity. As shown in at leastFIGS. 5A-5C, thetissue site102 or wound122, may be through anepidermis124 and into asubcutaneous tissue126 or any other tissue. Thetissue site102 may be the bodily tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, body cavity or any other tissue. Treatment of thetissue site102 may include removal of fluids, e.g., exudate or ascites.
• Referring still toFIGS. 1-5C, thedistribution manifold112 is proximate thetissue site102 and has afirst side128 and a second, tissue-facingside130. The term “distribution manifold” as used herein generally refers to a substance or structure that is provided to assist in applying reduced pressure to, delivering fluids to, or removing fluids from thetissue site102. Thedistribution manifold112 typically includes a plurality of flow channels or pathways that distribute fluids provided to and removed from thetissue site102 around thedistribution manifold112. In one illustrative embodiment, the flow channels or pathways are interconnected to improve distribution of fluids provided or removed from thetissue site102. Thedistribution manifold112 may be a biocompatible material that is capable of being placed in contact with thetissue site102 and distributing reduced pressure to thetissue site102. Examples of thedistribution manifold112 may include, without limitation, devices that have structural elements arranged to form flow channels, such as, for example, cellular foam, open-cell foam, porous tissue collections, liquids, gels, and foams that include, or cure to include, flow channels. Thedistribution manifold112 may be porous and may be made from foam, gauze, felted mat, or any other material suited to a particular biological application. In one embodiment, thedistribution manifold112 is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, Tex. In some situations, thedistribution manifold112 may also be used to distribute fluids such as medications, antibacterials, growth factors, and various solutions to thetissue site102. Other layers may be included in or on thedistribution manifold112, such as absorptive materials, wicking materials, hydrophobic materials, and hydrophilic materials.
• In one illustrative thedistribution manifold112 may be constructed from bioresorbable materials that do not have to be removed from a patient's body following use of thesystem100. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones. Thedistribution manifold112 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with thedistribution manifold112 to promote cell-growth. A scaffold is a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.
• Thedistribution manifold112 may be covered by the sealingmember114, which may also be referred to as a drape. The sealingmember114 forms a sealedspace132 over thetissue site102. The sealingmember114 has afirst side134, and a second, tissue-facing side136. The sealingmember114 may be any material that provides a fluid seal. “Fluid seal,” or “seal,” means a seal adequate to maintain reduced pressure at a desired site given the particular reduced-pressure source or subsystem involved. The sealingmember114 may, for example, be an impermeable or semi-permeable, elastomeric material. “Elastomeric” means having the properties of an elastomer. Elastomer generally refers to a polymeric material that has rubber-like properties. More specifically, most elastomers have ultimate elongations greater than 100% and a significant amount of resilience. The resilience of a material refers to the material's ability to recover from an elastic deformation. Elastomers that are relatively less resilient may also be used as these elastomers are more likely to tear when faced with the cuttingelement118. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane (PU), EVA film, co-polyester, and silicones. Additional, specific examples of dressing sealing member materials include a silicone drape, 3M Tegaderm® drape, polyurethane (PU) drape such as one available from Avery Dennison Corporation of Pasadena, Calif. An additional, specific non-limiting example of a dressing sealing member material includes a 30 μm matt polyurethane film such as the Inspire™ 2317 manufactured by Exopack™ Advanced Coatings of Matthews, N.C.
• Anattachment device134 may be used to hold the sealingmember114 against a portion of the patient'sintact epidermis124 or another layer, such as a gasket or additional sealing member. Theattachment device134 may take numerous forms. For example, theattachment device134 may be a medically acceptable adhesive, such as a pressure-sensitive adhesive, that extends about a periphery or all of the sealingmember114. Theattachment device134 may also be a sealing ring or other device. Theattachment device134 is disposed on the second, tissue-facing side of the sealingmember114. Before use, theattachment device134 may be covered by a release liner (not shown).
• The reduced-pressure interface116 may be positioned adjacent to or coupled to the sealingmember114 to provide fluid access to thedistribution manifold112. Anotherattachment device138 similar to theattachment device134 may be used to hold the reduced-pressure interface116 against the sealingmember114. The reduced-pressure delivery conduit110 fluidly couples the reduced-pressure treatment unit108 and the reduced-pressure interface116. The reduced-pressure interface116 allows the reduced pressure to be delivered to thetissue site102. While the amount and nature of reduced pressure applied to a tissue site will typically vary according to the application, the reduced pressure will typically be between −5 mm Hg (−667 Pa) and −500 mm Hg (−66.7 kPa) and more typically between −75 mm Hg (−9.9 kPa) and −300 mm Hg (−39.9 kPa). For example, and not by way of limitation, the pressure may be −12, −12.5, −13, −14, −14.5, −15, −15.5, −16, −16.5, −17, −17.5, −18, −18.5, −19, −19.5, −20, −20.5, −21, −21.5, −22, −22.5, −23, −23.5, −24, −24.5, −25, −25.5, −26, −26.5 kPa or another pressure.
• As shown, the reduced-pressure delivery conduit110 is a multi-lumen conduit. It should be understood, however, that the reduced-pressure delivery conduit110 may be in many forms and may comprise a single lumen. The reduced-pressure delivery conduit110 may include aprimary lumen142 and at least onesensing lumen144. In one illustrative embodiment theprimary lumen142 is acentral lumen146 and the at least onesensing lumen144 is one or moreperipheral lumens148. Theprimary lumen142 and the at least onesensing lumen144 are adapted to maintain fluid isolation between theprimary lumen142 and the at least onesensing lumen144 as the reduced-pressure delivery conduit110 transports fluids from the reduced-pressure interface116 to the reduced-pressure treatment unit108. Liquids or exudates communicated from thedistribution manifold112 through theprimary lumen142 are removed from the reduced-pressure delivery conduit110 and retained within a liquid-collection chamber (not explicitly shown) in fluid communication with the reduced-pressure treatment unit108. The at least onesensing lumen144 fluidly communicates reduced pressure representative of thetissue site102 to aninstrumentation unit150.
• The reduced-pressure treatment unit108 may include a liquid-collection chamber, or a collection canister, and theinstrumentation unit150 in fluid communication with a reduced-pressure source140. Theinstrumentation unit150 may include amicroprocessor154 adapted to process pressure signals received by the reduced-pressure delivery conduit110, monitor the pressure signals, and issue alerts according to a pre-determined pressure configuration. The pre-determined pressure configuration may include a pressure set-up pattern of sustained decrease, increase, and relative stability within an application time period as will be described in more detail with respect toFIG. 10 below.
• In an illustrative embodiment, the reduced-pressure source140 is an electrically-driven vacuum pump. In another implementation, the reduced-pressure source140 may instead be a manually-actuated or manually-charged pump that does not require electrical power. The reduced-pressure source140 instead may be any other type of reduced pressure pump, or alternatively a wall suction port such as those available in hospitals and other medical facilities. The reduced-pressure source140 may be housed within or used in conjunction with the reduced-pressure treatment unit108, which may also include theinstrumentation unit150. Theinstrumentation unit150 may include sensors, processing units, alarm indicators, memory, databases, software, display units, and user interfaces that further facilitate the application of reduced pressure treatment to thetissue site102.
• In one example, pressure-detection sensors (not shown) located in theinstrumentation unit150 may be disposed at or near the reduced-pressure source140. The pressure-detection sensors may receive pressure data, or a pressure signal, from the reduced-pressure interface116 via the at least onesensing lumen144 that is dedicated to delivering reduced pressure data to the pressure-detection sensors. The pressure signal or data may be representative of a pressure at adistal end186 of the at least onesensing lumen144. The pressure-detection sensors may communicate with a processing unit that monitors and controls the reduced pressure that is delivered by the reduced-pressure source140. In one embodiment, the pressure-detection sensors communicate with the processing unit to monitor whether the pressure signal follows the pressure set-up pattern. In the event the pressure signal does not follow the pressure set-up pattern within an application time period that may be predetermined, theinstrumentation unit150 provides an indication to a caregiver. The indication may be in the form of a visual or audible alert or alarm. Other indications may be used. In an alternative, but not mutually exclusive, embodiment, the pressure-detection sensors may communicate with the processing unit to monitor whether the pressure signal does follow the pressure set-up pattern within an application time period. In the event the pressure signal does follow the pressure set-up pattern, theinstrumentation unit150 provides an indication to the caregiver. The indication that the pressure set-up pattern has been followed may be different than the indication that the pressure set-up pattern has not been followed.
• Referring now primarily toFIGS. 3-5C, an illustrative embodiment of the reduced-pressure interface116 is presented in more detail. The reduced-pressure interface116 includes ahousing158, aconduit port168 coupled to thehousing158, and theattachment device152 for coupling the reduced-pressure interface116 to the sealingmember114. The reduced-pressure interface116 further includes the cuttingelement118.
• Thehousing158 may have aflange portion160 and acavity wall portion162. Thecavity wall portion162 forms acavity164 having a tissue-facingcavity opening166. Theconduit port168 is coupled to or formed as part of thecavity wall portion162 of thehousing158. Theconduit port168 includes aconduit aperture170 whereby theconduit port168 is adapted to receive the reduced-pressure delivery conduit110. Theattachment device138 may be coupled to a tissue-facingside172 of theflange portion160 for coupling thehousing158 to thefirst side134 of the sealingmember114. Thehousing158 is made of a semi-rigid material that is capable of collapsing under a force such as a drivingforce174. In a non-limiting example, the reduced-pressure interface116, and thus thehousing158, may be made from a plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, and polyether block amide copolymer.
• The cuttingelement118 may be at least temporarily coupled to thehousing158 proximate to the tissue-facingcavity opening166. The cuttingelement118 is adapted to form theaperture120 in the sealingmember114 when the cuttingelement118 is driven into the sealingmember114 with the drivingforce174. The drivingforce174 may also cause thecutting element118 to penetrate or cut a portion of thedistribution manifold112. The drivingforce174 may be manually applied to anexterior184 of the reduced-pressure interface116 causing thehousing158 to collapse and thereby driving or pushing the cuttingelement118 into the sealingmember114. In another embodiment, the drivingforce174 is applied by applying reduced pressure to thecavity164 such that a cavity pressure (P_c) in thecavity164 is less than a threshold pressure (P_t). When the cavity pressure (P_c) is less than the threshold pressure (P_t), thecavity wall portion162 collapses and with continued reduced pressure impacts thecutting element118 thereby driving a portion of the cuttingelement118 through the sealingmember114. The threshold pressure (P_t) is at least in part dependent on the type and thickness of the material used for thehousing158. In the event reduced pressure is applied to thecavity164, a tensile force may be applied to the sealingmember114 causing the sealingmember114 to pull into thecavity164. This movement further assists with the cuttingelement118 moving into the sealingmember114.
• In one embodiment, the cuttingelement118 includes abase member176 and astylus member178 coupled to thebase member176. Thestylus member178 has aleading edge180 and is configured to perforate the sealingmember114 to form theaperture120 in the sealingmember114. In one embodiment, theleading edge180 is serrated. In another embodiment, theleading edge180 is serrated or configured to perforate the sealingmember114 orthogonally. The sealingmember114 may be perforated orthogonally to inhibit thecut sealing member114 from blocking the reduced-pressure delivery conduit110 during reduced pressure therapy. Thebase member176 may be sized and configured to form an interference fit with the tissue-facingcavity opening166, whereby the cuttingelement118 is releasably coupled to thehousing158. Thus, in one embodiment, the cuttingelement118 may be removed prior to use if not desired or after perforating the sealingmember114.
• The cuttingelement118 may have a piercing length (L_p) extending the length (L) of thestylus member178. The length (L) of thestylus member178 extends from thebase member176 to atip182 of thestylus member178. In one embodiment, the piercing length (L_p) is less than 3 centimeters. In another embodiment, the piercing length (L_p) is less than 2 centimeters. Thedistribution manifold112 may have a thickness greater than T when subject to reduced pressure such that the piercing length (L_p) of the cuttingelement118 is less than the thickness T, i.e., L_p<T. One benefit of the piercing length (L_p) being less than the thickness, T, of thedistribution manifold112 under reduced pressure is that the cuttingelement118 cannot completely cut through thedistribution manifold112 and reach thetissue site102.
• As previously mentioned, the cuttingelement118 may be only temporarily coupled to thehousing158. In one embodiment, the cuttingelement118 may be removed by a care giver. In another embodiment, the cuttingelement118 may be formed from a liquid soluble material such as a water soluble material adapted to allow thecutting element118 to dissolve. For example, the water soluble material may include at least one of the following: Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, sugars (sucrose, glucose, fructose), weak acids (tartaric, citric, malic), salts (sodium chloride, sodium carbonate, sodium bicarbonate), polyethylene oxide (PEO), polyethylene glycol (PEG). The cuttingelement118 may dissolve as liquids are removed from thetissue site102. Reduced pressure is applied to the reduced-pressure interface116 after perforating the sealingmember114 typically causing liquids to be removed from thetissue site102. After a sufficient amount of time, liquids removed from thetissue site102 cause thecutting element118 to substantially dissolve. The cuttingelement118 may dissolve within 2 minutes, 5 minutes, 10 minutes, or another time period. As thecutting element118 is dissolved it is removed by the reduced-pressure delivery conduit110 with liquids from thetissue site102. A liquid, e.g., saline solution, may also be introduced through the reduced-pressure delivery conduit110 or otherwise to dissolve thecutting element118.
• As shown inFIG. 5C, once the cuttingelement118 has substantially dissolved, reduced pressure applied through the reduced-pressure interface116 creates sufficient reduced pressure in thecavity164 to pull a portion of thedistribution manifold112 into thecavity164 such that thedistribution manifold112 abuts a distal end of the reduced-pressure delivery conduit110 to include adistal aperture186 of the at least onesensing lumen144. Allowing thedistribution manifold112 to completely abut the distal end of the reduced-pressure delivery conduit110 may help ensure fluid isolation between each of the lumens in the reduced-pressure delivery conduit110. Thedistribution manifold112 may provide a barrier between theprimary lumen142 and the at least onesensing lumen144. Additionally, having the reduced-pressure delivery conduit110 in direct contact with thedistribution manifold112 may help ensure that there is a constant low velocity liquid flow into the reduced-pressure delivery conduit110 which may minimize the instance of aerosolized particles being deposited around the at least onesensing lumen144 and may also provide a filter to liquids entering the at least onesensing lumen144.
• In operation, a caregiver may treat thetissue site102 on thepatient104 with a method that includes disposing thedistribution manifold112 proximate to thetissue site102. Thedistribution manifold112 and a portion ofintact epidermis124 of thepatient104 is covered with the sealingmember114 to form the sealedspace132 in which thedistribution manifold112 is disposed. The reduced-pressure interface116 is coupled to the sealingmember114. The reduced-pressure delivery conduit110 is fluidly coupled on one end to the reduced-pressure source140 and on the opposing end to the reduced-pressure interface116. The drivingforce174 is then applied to the reduced-pressure interface116 with sufficient strength to cause thecutting element118 to perforate (e.g., pierce, tear, cut or otherwise create the aperture120) the sealingmember114.
• In one embodiment, the reduced-pressure interface116 includes thehousing158 having the wall portion, wherein the wall portion forms thecavity164 having the tissue-facingcavity opening166. Thehousing158 is formed of a semi-rigid material that collapses when under reduced pressure less than the threshold pressure (P_t). Theconduit port168 is coupled to the wall portion of thehousing158. Theconduit port168 is further coupled to the reduced-pressure delivery conduit110. Reduced pressure is supplied to the reduced-pressure interface116 through the reduced-pressure delivery conduit110 and theconduit port168. When reduced pressure levels in thecavity164 are less than the threshold pressure (P_t), the wall portion collapses under the drivingforce174 and impacts thecutting element118, driving a portion of the cuttingelement118 through the sealingmember114 to perforate the sealingmember114.
• In one embodiment, in response to the sealingmember114 being perforated, liquid is removed from thetissue site102 through the reduced-pressure delivery conduit110. Liquid is removed from thetissue site102 by virtue of reduced pressure. The liquid causes thecutting element118 to dissolve. Once the cuttingelement118 has substantially dissolved, reduced pressure within thecavity164 of the reduced-pressure interface116 causes a portion of thedistribution manifold112 to be pulled into thecavity164 and abut the reduced-pressure delivery conduit110. Fluid may then be directly transferred from thedistribution manifold112 to the reduced-pressure delivery conduit110 without going through an additional medium or open space.
• Referring now primarily toFIGS. 6-9C, another illustrative embodiment of a reduced-pressure interface216 is presented. The reduced-pressure interface216 is analogous in many respects to the reduced-pressure interface116 ofFIGS. 3-5C. The reduced-pressure interface216 includes ahousing258 and a cutting element218. Thehousing258 may have aflange portion260 and acavity wall portion262. Theflange portion260 may be coupled to the sealingmember114 by theattachment device138. Thecavity wall portion262 is collapsible under reduced pressure. Thecavity wall portion262 may include abellows configuration290 for permitting thecavity wall portion262 to collapse when acavity164 pressure (P_c) inside acavity264 is less than a threshold pressure (P_t) on an absolute pressure side.
• The cutting element218 may include aconduit adapter292, anadapter flange294, atube extension296, abase member276, and astylus member278. Theconduit adapter292 is configured to receive the reduced-pressure delivery conduit110 to provide fluid communication between the reduced-pressure treatment unit108 and thetissue site102. Theconduit adapter292 includes aprotrusion293 for engaging theprimary lumen142 of the reduced-pressure delivery conduit110. Theprotrusion293 may be sized and configured to extend into theprimary lumen142 and to form an interference fit. Theprotrusion293 may help maintain fluid isolation between theprimary lumen142 and the at least onesensing lumen144. Theadapter flange294 is positioned on anexterior284 of thecavity wall portion262. Thetube extension296 is connected to theadapter flange294 and is sized and configured to mate with aconduit aperture298. Thetube extension296 is further configured to extend through theconduit aperture298. In a specific, non-limiting example, theconduit adapter292, theadapter flange294, and thetube extension296 may be formed from materials to include plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, and polyether block amide copolymer.
• Thebase member276 may be at least temporarily coupled to thetube extension296. Thestylus member278 is directly coupled to thebase member276 and may include afirst blade297 and asecond blade299 configured to make orthogonal cuts in the sealingmember114 when thehousing258 is compressed with a driving force thereby impacting the cutting element218. Thestylus member278 is thus driven into the sealingmember114. The driving force may be manually applied to theexterior284 of the reduced-pressure interface216 causing thehousing258 to collapse and thereby driving or pushing the cutting element218 into the sealingmember114. In another embodiment, the driving force is applied by applying reduced pressure to thecavity264 such that the cavity pressure (P_c) in thecavity264 is less than a threshold pressure (P_t). When the cavity pressure (P_c) in thecavity264 is less than the threshold pressure (P_t), thecavity wall portion262 collapses and impacts the cutting element218. With continued reduced pressure, a portion of the cutting element218 is driven through the sealingmember114. The threshold pressure (P_t) is at least in part dependent on the type and thickness of material used for thehousing258. In the event reduced pressure is applied to thecavity264, atensile force273 may be applied to the sealingmember114 causing the sealingmember114 to be pulled into thecavity264. This movement helps the cutting element218 to be driven into the sealingmember114.
• As previously mentioned, thebase member276 may be only temporarily coupled to thehousing258. In one embodiment, thebase member276 and thestylus member278 may be formed from a liquid soluble material such as a water soluble material adapted to allow thecutting element118 to dissolve. The water soluble material may include at least one of the following: Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, sugars (sucrose, glucose, fructose), weak acids (tartaric, citric, malic), salts (sodium chloride, sodium carbonate, sodium bicarbonate), polyethylene oxide (PEO), polyethylene glycol (PEG). Thebase member276 and thestylus member278 may dissolve as liquids are removed from thetissue site102. Reduced pressure is applied to the reduced-pressure interface216 typically causing liquids to be removed from thetissue site102. After a sufficient amount of time, liquids removed from thetissue site102 may cause thebase member276 and thestylus member278 to substantially dissolve. Thebase member276 and thestylus member278 may dissolve within 2 minutes, 5 minutes, 8 minutes, 10 minutes, or another time period. As thebase member276 and thestylus member278 are dissolved, thebase member276 and thestylus member278 are removed by the reduced-pressure delivery conduit110 with the liquids from thetissue site102. While thebase member276 and thestylus member278 may be dissolvable, it is worth noting that theconduit adapter292, theadapter flange294, and thetube extension296 do not dissolve.
• Once thebase member276 and thestylus member278 have substantially dissolved, reduced pressure applied through the reduced-pressure interface216 creates sufficient reduced pressure in thecavity264 to pull a portion of thedistribution manifold112 into thecavity264 and theprimary lumen142 of the reduced-pressure delivery conduit110. Thedistribution manifold112 abuts the distal end of the reduced-pressure delivery conduit110 including thedistal aperture186 of the at least onesensing lumen144. Allowing thedistribution manifold112 to completely abut the distal end of the reduced-pressure delivery conduit110 may help ensure fluid isolation between each of the lumens in the reduced-pressure delivery conduit110.
• Referring now primarily toFIG. 10, a schematic diagram of a pressure set-up pattern is presented. The pressure set-up pattern may be a pre-determined pressure configuration. Pressure-detection sensors may communicate with a processing unit to monitor whether pressure signals received from a reduced-pressure interface follow or is consistent with the pressure set-up pattern. The pressure set-up pattern may be representative of whether a cutting element of the reduced-pressure interface has pierced a sealing member. The pressure set-up pattern may represent four main events. First, a period of sustained pressure decrease (reduced pressure increase) may be indicative of a period of time prior to the cutting element piercing the sealing member. This segment is shown generally byreference numeral302. During this period of time, pressure is decreasing in a cavity of the reduced-pressure interface causing the cavity to collapse. Second, a threshold pressure (P_t) is reached and pressure increases (reduced pressure decreases) indicating that the cutting element has pierced the sealing member. This segment is generally shown bynumeral304. The pressure should increase as the pressure in the sealed space beneath the sealing member stabilizes. And third, a period of pressure stability is reached as shown generally asreference numeral306.
• Although the present invention and its advantages have been disclosed in the context of certain illustrative, non-limiting embodiments, it should be understood that various changes, substitutions, permutations, and alterations can be made without departing from the scope of the invention as defined by the appended claims. It will be appreciated that any feature that is described in connection to any one embodiment may also be applicable to any other embodiment.
• It will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments. It will further be understood that reference to ‘an’ item refers to one or more of those items.
• The steps of the methods described herein may be carried out in any suitable order, or simultaneously where appropriate.
• Where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems.
• It will be understood that the above description of preferred embodiments is given by way of example only and that various modifications may be made by those skilled in the art. The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the invention. Although various embodiments of the invention have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of the claims.

Claims (40)

We claim:

1. An interface for treating a tissue site, the interface comprising:

a housing having a flange and a cavity wall, the cavity wall comprising a bellows;

a cutting element coupled to the housing, the cutting element comprising:

a conduit adapter comprising a conduit aperture and a protrusion;

an adapter flange configured to be positioned on an exterior portion of the cavity wall;

a tube extension coupled to the adapter flange and configured to mate with the conduit aperture;

a base member coupled to the tube extension; and

a stylus member coupled to the base member; and

an attachment device coupled to a tissue-facing side of the flange and configured to couple the flange to a sealing member;

wherein the bellows are configured to collapse and drive the cutting element through the sealing member.

2. The interface ofclaim 1, further comprising a multi-lumen conduit fluidly coupled to the conduit adapter.

3. The interface ofclaim 2, wherein the multi-lumen conduit comprises a primary lumen and at least one sensing lumen.

4. The interface ofclaim 3, wherein the conduit aperture is configured to receive the multi-lumen conduit and the protrusion is configured to engage the primary lumen.

5. The interface ofclaim 4, wherein the protrusion is configured to extend into the primary lumen and form an interference fit with the primary lumen.

6. The interface ofclaim 4, wherein the protrusion is configured to fluidly isolate the primary lumen from the at least one sensing lumen.

7. The interface ofclaim 1, wherein the tube extension is configured to extend through the conduit aperture.

8. The interface ofclaim 1, wherein the conduit adapter, the adapter flange, and the tube extension are formed from at least one of the following: plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, polyether block amide copolymer.

9. The interface ofclaim 1, wherein the base member is temporarily coupled to the tube extension.

10. The interface ofclaim 1, wherein the cutting element is formed from a water soluble material.

11. The interface ofclaim 10, wherein the water soluble material comprises at least one of the following: Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, a sugar, a weak acid, a salt, polyethylene oxide (PEO), polyethylene glycol (PEG).

12. The interface ofclaim 1, wherein the base member is formed from a water soluble material.

13. The interface ofclaim 12, wherein the water soluble material comprises at least one of the following: Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, a sugar, a weak acid, a salt, polyethylene oxide (PEO), polyethylene glycol (PEG).

14. The interface ofclaim 1, wherein the attachment device comprises an adhesive.

15. The interface ofclaim 1, wherein the stylus comprises a first blade and a second blade configured to make orthogonal cuts in the sealing member.

16. The interface ofclaim 15, wherein the stylus is configured to perforate the sealing member to form an access aperture in the sealing member and to apply a tensile force on the access aperture.

17. The interface ofclaim 1, wherein the bellows are configured to collapse when a pressure inside the bellows is less than a threshold pressure.

18. The interface ofclaim 1, wherein the bellows are configured to collapse in response to a driving force applied to the bellows.

19. The interface ofclaim 18, wherein the driving force is manually applied to the bellows.

20. The interface ofclaim 18, wherein the driving force comprises reduced pressure applied to a cavity within the bellows.

21. An interface for treating a tissue site, the interface comprising:

a housing having a flange and a cavity wall, the cavity wall comprising a bellows;

a cutting element coupled to the housing; and

an attachment device coupled to a tissue-facing side of the flange and configured to couple the flange to a sealing member;

wherein the bellows are configured to collapse and drive the cutting element through the sealing member.

22. The interface ofclaim 20, wherein the cutting element further comprises:

a conduit adapter comprising a conduit aperture and a protrusion;

an adapter flange configured to be coupled to an exterior portion of the cavity wall;

a tube extension coupled to the adapter flange;

a base member coupled to the tube extension; and

a stylus member coupled to the base member and comprising a first blade and a second blade.

23. The interface ofclaim 22, wherein the tube extension is configured to mate with the conduit aperture.

24. The interface ofclaim 22, wherein the tube extension is configured to extend through the conduit aperture.

25. The interface ofclaim 22, further comprising a multi-lumen conduit fluidly coupled to the conduit adapter.

26. The interface ofclaim 25, wherein the multi-lumen conduit comprises a primary lumen and at least one sensing lumen.

27. The interface ofclaim 26, wherein the conduit aperture is configured to receive the multi-lumen conduit and the protrusion is configured to engage the primary lumen.

28. The interface ofclaim 27, wherein the protrusion is configured to extend into the primary lumen and form an interference fit with the primary lumen.

29. The interface ofclaim 27, wherein the protrusion is configured to fluidly isolate the primary lumen from the at least one sensing lumen.

30. The interface ofclaim 22, wherein the base member is temporarily coupled to the tube extension.

31. The interface ofclaim 22, wherein the conduit adapter, the adapter flange, and the tube extension are formed from at least one of the following: plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, polyether block amide copolymer.

32. The interface ofclaim 22, wherein the stylus comprises a first blade and a second blade configured to make orthogonal cuts in the sealing member.

33. The interface ofclaim 32, wherein the stylus is configured to perforate the sealing member to form an access aperture in the sealing member and to apply a tensile force on the access aperture.

34. The interface ofclaim 20, wherein the cutting element is formed from a water soluble material.

35. The interface ofclaim 34, wherein the water soluble material comprises at least one of the following: Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl and carboxyl modified acrylics, starch, a sugar, a weak acid, a salt, polyethylene oxide (PEO), polyethylene glycol (PEG).

36. The interface ofclaim 20, wherein the attachment device comprises an adhesive.

37. The interface ofclaim 20, wherein the bellows are configured to collapse when a pressure inside the bellows is less than a threshold pressure.

38. The interface ofclaim 20, wherein the bellows are configured to collapse in response to a driving force applied to the bellows.

39. The interface ofclaim 38, wherein the driving force is manually applied to the bellows.

40. The interface ofclaim 38, wherein the driving force comprises reduced pressure applied to a cavity within the bellows.

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