RELATED APPLICATIONSThis application is a Divisional of U.S. patent application Ser. No. 15/546,268, filed Jul. 25, 2017, which is a U.S. National Stage Entry of PCT/US2016/014645, filed Jan. 23, 2016, which claims the benefit, under 35 USC 119(e), of the filing of U.S. Provisional Patent Application No. 62/110,870, entitled “Customizable Closed Tissue Site Dressing for Improved Postoperative Removal,” filed Feb. 2, 2015, which are incorporated herein by reference for all purposes.
FIELDThis disclosure relates generally to medical treatment systems and, more particularly, but not by way of limitation, to systems, dressings, devices, and methods that may be suitable for treating a tissue site.
BACKGROUNDDepending on the medical circumstances, reduced pressure may be used for, among other things, reduced-pressure therapy to encourage granulation at a tissue site, draining fluids at a tissue site, closing a wound, reducing edema, promoting perfusion, and fluid management. Challenges can exist with extracting fluids from a tissue site under reduced-pressure therapy. For example, tissue sites may vary in volume, size, geometry, orientation, and other factors. Further, access to these tissue sites may be restricted. These and other factors can make extraction of waste fluids from the tissue site difficult to perform.
Types of tissue sites that may present particular difficulties may include locations such as a peritoneal cavity, and more generally, an abdominal cavity. For example, the abdominal cavity can be prone to complications such as peritonitis, abdominal compartment syndrome, and infections that can inhibit healing. Thus, improvements to treatment systems that may adapt to various types of tissue sites and orientations, reduce the invasiveness of the treatment, and increase efficiency and healing times may be desirable.
SUMMARYIn some illustrative embodiments, a system for treating a tissue site may include a fluid hub, a plurality of elongate fluid members, a separable joint, a pneumatic connector, and a reduced-pressure source. The plurality of elongate fluid members may be positioned in fluid communication with the fluid hub. Each of the plurality of elongate fluid members may include a proximal end, a distal end, and an elongate side between the proximal end and the distal end. The elongate side of the plurality of elongate fluid members may extend longitudinally outward from the fluid hub. The separable joint may be coupled between the elongate side of one of the plurality of elongate fluid members and the elongate side of another of the plurality of elongate fluid members. The pneumatic connector may be positioned in fluid communication with the plurality of elongate fluid members. The reduced-pressure source may be adapted to be positioned in fluid communication with the pneumatic connector.
In some illustrative embodiments, a dressing for treating a tissue site may include a fluid hub, a plurality of elongate fluid members, and a separable joint. The plurality of elongate fluid members may be positioned in fluid communication with the fluid hub. Each of the plurality of elongate fluid members may include a proximal end, a distal end, and an elongate side between the proximal end and the distal end. The elongate side of the elongate fluid members may extend longitudinally outward from the fluid hub. The separable joint may be coupled between the elongate side of one of the plurality of elongate fluid members and the elongate side of another of the plurality of elongate fluid members.
In some illustrative embodiments, a dressing for treating a tissue site may include a fluid hub, a first elongate fluid member, a second elongate fluid member, a separable joint, and a pneumatic connector. The first elongate fluid member may include a first proximal end, a first distal end, and a first elongate side defined between the first proximal end and the first distal end. The first distal end may be coupled in fluid communication to the fluid hub. The second elongate fluid member may include a second proximal end, a second distal end, and a second elongate side defined between the second proximal end and the second distal end. The second proximal end may be coupled in fluid communication to the fluid hub. The separable joint may be coupled between the first elongate side and the second elongate side and may be configured to releasably couple the first elongate side to the second elongate side. The pneumatic connector may be coupled in fluid communication at the first proximal end of the first elongate fluid member. Further, the pneumatic connector and the first proximal end of the first fluid member may be in fluid communication with the second distal end of the second fluid member through the fluid hub.
In some illustrative embodiments, a method for treating a tissue site may include providing a dressing. The dressing may include a plurality of elongate fluid members and a pneumatic connector. The plurality of elongate fluid members may include a proximal end, a distal end, and an elongate side between the proximal end and the distal end. The pneumatic connector may be positioned in fluid communication with the plurality of elongate fluid members. Further, the method may include positioning the plurality of elongate fluid members across the tissue site, and positioning the pneumatic connector through an external opening of the tissue site. Further, the method may include moving a fluid from the tissue site along the plurality of elongate fluid members to the pneumatic connector, and extracting the fluid through the pneumatic connector. Further, the method may include removing the plurality of elongate fluid members from the tissue site through the external opening by applying a removal force to the pneumatic connector.
In some illustrative embodiments, a method for removing a dressing from a tissue site may include providing the dressing positioned at the tissue site. The dressing may include a plurality of elongate fluid members, a pneumatic connector, and a separable joint. The plurality of elongate fluid members may include a proximal end, a distal end, and an elongate side between the proximal end and the distal end. The plurality of elongate fluid members may be positioned across the tissue site. The pneumatic connector may be positioned in fluid communication with the plurality of elongate fluid members. The pneumatic connector may extend through an external opening of the tissue site. The separable joint may be coupled between the elongate side of one of the plurality of elongate fluid members and the elongate side of another of the plurality of elongate fluid members. Further, the method may include removing the plurality of elongate fluid members from the tissue site through the external opening by applying a removal force to the pneumatic connector.
In some illustrative embodiments, a method for placing a dressing at a tissue site may include providing a dressing. The dressing may include a plurality of elongate fluid members and a pneumatic connector. The plurality of elongate fluid members may include a proximal end, a distal end, and an elongate side between the proximal end and the distal end. The pneumatic connector may be positioned in fluid communication with the plurality of elongate fluid members. Further, the method may include positioning the plurality of elongate fluid members across the tissue site, and positioning the pneumatic connector through an external opening of the tissue site. Positioning the plurality of elongate fluid members across the tissue site may include spacing the elongate side of at least one of the elongate fluid members apart from the elongate side of another of the elongate fluid members.
Other aspects, features, and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a partial cut-away view of an illustrative embodiment of a system for treating a tissue site deployed at an illustrative tissue site;
FIG. 2A is a plan view of an illustrative embodiment of a dressing shown in the system ofFIG. 1, depicting an illustrative embodiment of a plurality of elongate fluid members coupled to one another for positioning at the tissue site;
FIG. 2B is a cross-section of the dressing ofFIG. 2A, taken alongline2B-2B inFIGS. 1 and 2A;
FIG. 3 is a plan view of the dressing ofFIG. 2A, depicting the plurality of elongate members disconnected and separated from one another;
FIG. 4A is another illustrative embodiment of a dressing suitable for use with the system ofFIG. 1;
FIG. 4B is a cross-section of the dressing ofFIG. 4A, taken alongline4B-4B inFIG. 4A;
FIG. 5A is a plan view of the dressing ofFIG. 4A, depicting the plurality of elongate members disconnected and separated from one another; and
FIG. 5B is a perspective view of the dressing ofFIG. 4A, depicting the plurality of elongate members disconnected from one another and gathered together for removal from the tissue site.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTSIn the following detailed description of non-limiting, illustrative embodiments, reference is made to the accompanying drawings that form a part hereof. Other embodiments may be utilized, and logical, structural, mechanical, electrical, and chemical changes may be made without departing from the scope of the appended claims. 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 non-limiting, and the scope of the illustrative embodiments are defined by the appended claims. As used herein, unless otherwise indicated, “or” does not require mutual exclusivity.
Referring toFIG. 1, in some illustrative embodiments, asystem102 may include atherapy device104, apneumatic connector106, a sealingmember108, and adressing110. In other embodiments, components of thesystem102 may be omitted or added as appropriate for specific applications. Thesystem102 may be suitable for providing reduced pressure treatment at atissue site116.
Thetissue site116 may be may be the bodily tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue. Thetissue site116 may extend through or otherwise involve anepidermis118, adermis120, and asubcutaneous tissue122. In some embodiments, thetissue site116 may be a sub-surface tissue site as depicted inFIG. 1 that extends below the surface of theepidermis118. Anexternal opening117 may extend between thetissue site116 and an exterior of thetissue site116 to permit, without limitation, connection, placement, operation, or removal of components of thesystem102. In other embodiments, thetissue site116 may be a surface tissue site (not shown) that predominantly resides on a surface of theepidermis118.
As shown inFIG. 1, thetissue site116 may include tissue in a body cavity such as, without limitation, anabdominal cavity124. Theabdominal cavity124 may includeabdominal contents126 or other tissue proximate theabdominal cavity124. The dressing110 may be disposed in theabdominal cavity124 and supported on a surface of theabdominal contents126. The dressing110 may also be positioned in or proximate to a left lateral or firstparacolic gutter128 and a right lateral or secondparacolic gutter130. The firstparacolic gutter128 and the secondparacolic gutter130 may each be, for example, an open space on opposing sides of theabdominal cavity124 among theabdominal contents126. The firstparacolic gutter128 may be laterally disposed from the secondparacolic gutter130 or otherwise positioned on an opposite side of thetissue site116 from the secondparacolic gutter130. Thepneumatic connector106 may be adapted to be positioned at theexternal opening117 of thetissue site116, for example, extending into theabdominal cavity124. In some embodiments, thepneumatic connector106 may be adapted to extend through theexternal opening117. AlthoughFIG. 1 depicts thesystem102 deployed at theabdominal cavity124, thesystem102 may be used without limitation at other types of tissue sites. Further, the treatment of thetissue site116 may include, without limitation, the removal of fluids, such as ascites and exudates, reduced-pressure therapy, instillation or distribution of fluids to thetissue site116, and protection of thetissue site116.
Thetherapy device104 may be adapted to be positioned or coupled in fluid communication with thepneumatic connector106 and thedressing110. In some illustrative embodiments, thetherapy device104 may include a reduced-pressure source136 and acanister138. Further, in some embodiments, thetherapy device104 may optionally include and a sensor140 and acontroller146. The components of thetherapy device104 may be arranged or associated with one another as shown inFIG. 1 to form thetherapy device104. However, in other embodiments (not shown), the components of thetherapy device104 may be provided separately or independently from thetherapy device104. Further, components of thetherapy device104 may be added or omitted as desired for a particular application.
The reduced-pressure source136 may be adapted to be positioned or coupled in fluid communication with thepneumatic connector106 and thedressing110. In some embodiments, the reduced-pressure source136 may be a pump, such as a portable pump. In other embodiments, the reduced-pressure source136 may be any suitable device for providing reduced pressure, such as, for example, a wall suction source, a hand pump, or other source.
Thecanister138 may be positioned in fluid communication between the reduced-pressure source136 and thepneumatic connector106. For example, the reduced-pressure source136 may be positioned in fluid communication with thepneumatic connector106 and the dressing110 through thecanister138 such that fluid from thetissue site116 and the dressing110 maybe drawn into thecanister138. Thecanister138 may be in fluid communication with a reduced-pressure inlet148 of the reducedpressure source136. Thecanister138 may be any suitable containment device for holding or communicating fluids.
The sensor140 may be, without limitation, a pressure sensor, a temperature sensor, or other sensor. Thecontroller146 may be, for example, a processor or similar device configured to control components of thetherapy device104, and to monitor the treatment or state of thetissue site116. Thecontroller146 may be electrically coupled in any suitable manner to the reduced-pressure source136, the sensor140, or other components of thetherapy device104. For example,electrical conductors150 may electrically couple thecontroller146 to the reduced-pressure source136 and the sensor as shown inFIG. 1. Thecontroller146 may include software or user programmable settings for controlling components of thetherapy device104 in relation to one another. For example, thecontroller146 may control reduced pressure output from the reduced-pressure source136 according to a signal generated or received from the sensor140. The signal from the sensor140 may be, for example, a pressure signal, a temperature signal, or other signal.
Reduced pressure may be applied to thetissue site116 from the reduced-pressure source136 to promote removal of ascites, exudates, or other fluids from thetissue site116. Further, reduced pressure may be applied to stimulate the growth of additional tissue. In the case of a wound at thetissue site116, the growth of granulation tissue, removal of exudates, or removal of bacteria may promote healing. In the situation of a non-wounded or non-defective tissue, reduced pressure may promote the growth of tissue that may be harvested and transplanted to another tissue site.
As used herein, “reduced pressure” may refer to a pressure less than the ambient pressure at a tissue site subject to treatment. In some embodiments, the reduced pressure may be less than the atmospheric pressure. The reduced pressure may also be less than a hydrostatic pressure at a tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. The reduced pressure delivered may be a constant pressure, varied pressure, intermittent pressure, or continuous pressure. Although the terms “vacuum” and “negative pressure” may be used to describe the pressure applied to a tissue site, the actual pressure applied to the tissue site may be more than the pressure normally associated with a complete vacuum. An increase in reduced pressure may correspond to a reduction in pressure (more negative relative to ambient pressure), and a decrease in reduced pressure may correspond to an increase in pressure (less negative relative to ambient pressure). While the amount and nature of reduced pressure applied to a tissue site may vary according to the application, in some embodiments, the reduced pressure may be between about −5 mm Hg to about −500 mm Hg. In other embodiments, the reduced pressure may be between about −100 mm Hg to about −200 mm Hg. In yet other embodiments, the reduced pressure may be between about −50 mm Hg to about −300 mm Hg.
Further, in some embodiments, components of thesystem102, such as, without limitation, the reduced-pressure source136, thetherapy device104, or thecontroller146, may include preset selectors for an amount of reduced pressure, such as, for example, −100 mm Hg, −125 mm Hg, and −150 mm Hg. Further, thesystem102 may also include a number of alarms, such as, for example, a blockage alarm, a leakage alarm, or a battery-low alarm.
Continuing withFIG. 1, thepneumatic connector106 may be adapted to be accessible at theexternal opening117 of thetissue site116 to permit, for example, removal of the dressing110 from thetissue site116. In some embodiments, thepneumatic connector106 may be directly coupled, secured, or tethered to the dressing110, for example, by aweld151, to permit removal of the dressing110 from thetissue site116 by thepneumatic connector106. In some embodiments, thepneumatic connector106 may be directly coupled to the dressing110 with an adhesive or any suitable coupling device. Theweld151, adhesive, or other coupling device may also be used as described herein for coupling other components of thesystem102. In some embodiments, a portion or more of thepneumatic connector106 may be formed integrally with the dressing110, or from a substrate material of thedressing110.
Thetherapy device104 may be in fluid communication with the dressing110 through thepneumatic connector106. In some illustrative embodiments, thepneumatic connector106 may include afeedback lumen152, a reduced-pressure lumen154, aconduit interface156, and abridge158. Thepneumatic connector106 may be supplied as part of the dressing110, and components of thepneumatic connector106 may be added, omitted, or used in any suitable combination in other embodiments. For example, in some embodiments, thepneumatic connector106 may comprise a tube, lumen, pipe, or conduit that may be directly coupled in fluid communication with the dressing110 without thefeedback lumen152, theconduit interface156, or thebridge158. Further, thefeedback lumen152 and the reduced-pressure lumen154 may be combined or formed as part of amulti-lumen conduit160 as shown inFIG. 1. In other embodiments, thefeedback lumen152 and the reduced-pressure lumen154 may be separate conduits, tubes, lumens, or pipes, for example.
Thefeedback lumen152 may be positioned or coupled in fluid communication with the sensor140 in any suitable manner, such as, without limitation, through tubing, piping, or connectors coupled with adhesives, bonding, welding, couplers, unions, or interference fit. Similarly, the reduced-pressure lumen154 may be positioned or coupled in fluid communication with the reduced-pressure source136 in any suitable manner, such as, without limitation, through tubing, piping, or connectors coupled with adhesives, bonding, welding, couplers, unions, or interference fit. For example, the reduced-pressure lumen154 may be in fluid communication with the reduced-pressure source136 through thecanister138. Thus, thecanister138 may have an outlet in fluid communication with the reduced-pressure inlet148, and acanister inlet162 in fluid communication with the reduced-pressure lumen154 for delivering reduced pressure communicated from the reduced-pressure inlet148 to the reduced-pressure lumen154. The reduced-pressure source136, the reduced-pressure lumen154, and thecanister136 may be fluidly coupled to one another in any suitable manner, such as, without limitation, through tubing, piping, or connectors coupled with adhesives, bonding, welding, couplers, or interference fit. Further, in some embodiments, the reduced-pressure lumen154 may have a length that is fluidly isolated from a length of thefeedback lumen152.
In some embodiments, thebridge158 may include abridge manifold164 that may be surrounded or encapsulated by a bridge film166. Thebridge158, including thebridge manifold164 and the bridge film166, may be adapted to communicate fluid between thetherapy device104 and thedressing110. In some embodiments, the bridge film166 may be comprised of, or formed entirely of, a liquid impermeable material. Further, in some embodiments, the bridge film166 may comprise a non-adherent material, such as a medical drape, capable of inhibiting tissue from adhering to thebridge158. In some embodiments, the bridge film166 may comprise a breathable polyurethane film. Further, in some embodiments, bridge film166 may comprise any of the materials recited below for the sealingmember108.
In some embodiments, the bridge film166 may include a first bridge film166aand a second bridge film166b. Thebridge manifold164 may be surrounded between the first bridge film166aand the second bridge film166b. The first bridge film166amay be sealingly coupled to the second bridge film166bin any suitable manner, such as, for example, by theweld151. Although not shown inFIG. 1, theweld151, or other coupling device, may be positioned around the perimeter of thebridge manifold164 or at the edges of thebridge manifold164. Similar to the bridge film166, the first bridge film166aand the second bridge film166bmay be comprised of a liquid impermeable material or any of the materials recited or referenced above for the bridge film166. A bridge aperture168 may be disposed through the bridge film166 in fluid communication with thebridge manifold164.
Thebridge manifold164 may be formed from any manifold material or flexible bolster material that provides a vacuum space, or treatment space, such as, for example, a porous and permeable foam or foam-like material, a member formed with pathways, a graft, or a gauze. In some embodiments, any material or combination of materials may be used as a manifold material for thebridge manifold164 provided that the manifold material is operable to distribute or collect fluid across a tissue site. For example, the term manifold may refer to a substance or structure capable of delivering fluids to or removing fluids from across a tissue site through a plurality of pores, pathways, or flow channels. The plurality of pores, pathways, or flow channels may be interconnected to improve distribution of fluids provided to and removed from an area around the manifold. Examples of such manifolds may include, without limitation, devices that have structural elements arranged to form flow channels, cellular foam, such as open-cell foam, porous tissue collections, and liquids, gels, and foams that include or cure to include flow channels. Further, thebridge manifold164 may be biocompatible. In some embodiments, thebridge manifold164 may comprise a porous, hydrophobic material. In such an embodiment, the hydrophobic characteristics of thebridge manifold164 may prevent thebridge manifold164 from directly absorbing fluid, but may allow the fluid to pass through.
In some embodiments, thebridge manifold164 may be a reticulated, open-cell polyurethane or polyether foam that is fluid permeable. One such material may be the VAC® GranuFoam® material available from Kinetic Concepts, Inc. of San Antonio, Tex. However, a material with a higher or lower density than GranuFoam® material may be desirable for the manifold180 depending on the application. Among the many possible materials, the following may be used without limitation: GranuFoam® material; Foamex® technical foam (www.foamex.com); LIBELTEX DRY WEB; LIBELTEX TDL2; LIBELTEX TL4; a molded bed of nails structure; a patterned grid material, such as those manufactured by Sercol Industrial Fabrics; 3D textiles, such as those manufactured by Baltex of Derby, U.K.; a mass of filaments that may be adapted to provide a laminar fluid flow; a unidirectional manifold structure, such as a bundle of longitudinal filaments; a bundle of longitudinal filaments oriented substantially collinear to a desired direction of fluid flow; an array of polyamide monofilaments; a gauze; a flexible channel-containing member; and a graft.
In other embodiments, thebridge manifold164 may comprise a material including closed cells. The closed cells may not be fluidly connected to adjacent cells in thebridge manifold164. The closed cells may be selectively disposed in thebridge manifold164 to, for example, prevent transmission of fluids through perimeter surfaces of themanifold164. Other layers may be included in or on thebridge manifold164, such as absorptive materials, wicking materials, hydrophobic materials, and hydrophilic materials. In some embodiments, thebridge manifold164 may be enhanced with ionic silver and anti-microbial agents.
Theconduit interface156 may be any suitable connector, such as a coupling that may be molded, machined, formed or adapted in any suitable manner for providing fluid communication among components of thesystem102. For example, as shown inFIG. 1, theconduit interface156 may be adapted to fluidly couple thebridge158 to thefeedback lumen152 and the reduced-pressure lumen154. However, in other embodiments, theconduit interface156 may be directly coupled to the dressing110 without thebridge158. In yet other embodiments, theconduit interface156 may be coupled to the reduced-pressure lumen154 without thefeedback lumen152. Other embodiments are possible.
In some embodiments, theconduit interface156 may include aflange170 surrounding or positioned around an inlet of theconduit interface156. The inlet of theconduit interface156 may be in fluid communication with an outlet of theconduit interface156 that may be adapted to be fluidly coupled to thefeedback lumen152 and the reduced-pressure lumen154. Theflange170 may be adapted to be coupled to a component of thesystem102, such as thebridge158 or the dressing110, for example, with an adhesive172 or other coupling device. The adhesive172 may be adapted to be positioned between theflange170 and thebridge158 or thedressing110. For example, theflange170 may be positioned about the bridge aperture168 and coupled to a surface of thebridge158 with the adhesive172 to provide fluid communication among the inlet of theconduit interface156, thebridge manifold164, and thedressing110. The adhesive172 may also be used with other components of thesystem102. In other embodiments, theconduit interface156 may be positioned or coupled in fluid communication with components of thesystem102 in any suitable manner, such as, without limitation, through tubing, piping, or connectors coupled with adhesives, bonding, welding, couplers, unions, or interference fit.
The sealingmember108 may be adapted to cover at least a portion of the dressing110 and thetissue site116, and to provide a fluid seal and a sealedspace174 about thetissue site116 or between the sealingmember108 and thetissue site116. A portion of the sealingmember108 may overlap or cover tissue surrounding thetissue site116, such as theepidermis118. The dressing110 and a portion of thepneumatic connector106, such as thebridge158, may be sized or otherwise adapted to be positioned in the sealedspace174, and may be secured at theexternal opening117 of thetissue site116. Theexternal opening117 may provide access to thetissue site116 from an exterior of thetissue site116. The sealingmember108 may provide a fluid seal, for example, at, over, or covering theexternal opening117.
The sealingmember108 may be formed from any material that may allow for a fluid seal, such as, for example, a liquid impermeable material. A fluid seal may be a seal adequate to maintain reduced pressure, if applicable, at a desired site. The sealingmember108 may comprise, for example, one or more of the following materials: hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; hydrophilic silicone elastomers; an INSPIRE 2301 material from Expopack Advanced Coatings of Wrexham, United Kingdom having, for example, a moisture vapor transmission rate or MVTR (inverted cup technique) of 14400 g/m2/24 hours and a thickness of about 30 microns; a thin, uncoated polymer drape; 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; silicones; a silicone drape; a 3M Tegaderm® drape; a polyurethane (PU) drape such as one available from Avery Dennison Corporation of Pasadena, Calif.; polyether block polyamide copolymer (PEBAX), for example, from Arkema, France; EXPOPACK 2327; or other appropriate material.
The sealingmember108 may be vapor permeable and liquid impermeable, thereby allowing vapor and inhibiting liquids from exiting the sealedspace174. In some embodiments, the sealingmember108 may be a flexible, breathable film, membrane, or sheet having a high MVTR of, for example, at least about 300 g/m2 per 24 hours. The use of a high MVTR material for the sealingmember108 may permit moisture vapor to pass through the sealingmember108, external to the sealedspace174, while maintaining the fluid seal described above. In other embodiments, a low or no vapor transfer drape might be used. In some embodiments, the sealingmember108 may comprise a range of medically suitable films having a thickness between about 15 microns (μm) to about 50 microns (μm).
In some embodiments, the adhesive172, or other attachment device, may be adapted to be positioned between the sealingmember108 and thetissue site116. For example, the adhesive172 may be positioned on or applied to an interior facing side of the sealingmember108 for facing thetissue site116. In some embodiments, the sealingmember108 may be sealed directly against tissue surrounding thetissue site116, such as theepidermis118, by the adhesive172. In other embodiments, the adhesive172 may seal the sealingmember108 against a gasket or drape (not shown) adapted to be positioned between the adhesive172 and theepidermis118.
The adhesive172 may be a medically-acceptable adhesive and may take numerous forms, such as an adhesive sealing tape, drape tape, paste, hydrocolloid, hydrogel, or other suitable sealing device. The adhesive172 may also be flowable. Further, the adhesive172 may comprise, without limitation, an acrylic adhesive, rubber adhesive, high-tack silicone adhesive, polyurethane, or other adhesive substance. In some embodiments, the adhesive172 may be a pressure-sensitive adhesive comprising an acrylic adhesive with coat weight, for example, of about 15 grams/m2 (gsm) to about 70 grams/m2 (gsm). In some embodiments, the adhesive172 may be continuous or discontinuous.
Referring toFIG. 2A, in some illustrative embodiments, the dressing110 may include afluid hub202, a plurality of elongatefluid members206, and aseparable joint210. The elongatefluid members206 may be positioned in fluid communication with thefluid hub202. Each of the elongatefluid members206 may include aproximal end212, adistal end214, and anelongate side216 between theproximal end212 and thedistal end214. Theelongate side216 may extend longitudinally outward from thefluid hub202. Further, theelongate side216 may be positioned normal relative to theproximal end212 and thedistal end214 of the elongatefluid members206.
The separable joint210 may be coupled between theelongate side216 of one of the elongatefluid members206 and theelongate side216 of another of the elongatefluid members206. The separable joint210 may be configured to releasably couple theelongate side216 of one of the elongatefluid members206 to theelongate side216 of another of the elongatefluid members206. The separable joint210 may extend longitudinally outward from thefluid hub202, and may be positioned along or substantially parallel to one or more of the elongate sides216. Further, the separable joint210 may extend from thefluid hub202 to an outer edge or periphery of the dressing110 to facilitate separation of the elongatefluid members206 from one another at the outer edge and along one or more of the elongate sides216. The separable joint210 may intersect the outer edge or periphery of the dressing110 to facilitate the separation of the elongatefluid members206 from one another. In some embodiments, the separable joint210 may comprise perforations between adjacent elongatefluid members206. In other embodiments, the separable joint210 may comprise a score or other device adapted to enhance separation of the elongatefluid members206 from one another.
In some embodiments, the dressing110 may include thepneumatic connector106 shown inFIG. 1. Thepneumatic connector106 may be positioned or coupled in fluid communication with the dressing110 and the elongatefluid members206 through adressing aperture220. For example, thebridge158 may be coupled in fluid communication with the dressing110 at or about the dressingaperture220. The dressingaperture220 may be disposed through a portion of the dressing110 and in fluid communication with the contents of thedressing110. Further, thepneumatic connector106 may be coupled to at least one of the elongatefluid members206 and adapted to be accessible at theexternal opening117 of thetissue site116, for example, to permit removal of the elongatefluid members206 from thetissue site116.
Continuing withFIG. 2A, thefluid hub202 and the elongatefluid members206 may be adapted to communicate or distribute fluid throughout the dressing110. Thefluid hub202 may provide fluid communication between and among the elongatefluid members206. Thefluid hub202 may be positioned or coupled in fluid communication with the elongatefluid members206 in various configurations. For example, as shown inFIG. 2A, thefluid hub202 may be formed integrally with the elongatefluid members206, or from a portion of a substrate material of the elongatefluid members206 or thedressing110. Further, as shown inFIG. 2A, thefluid hub202 may be free of thewelds151 and theseparable joint210. In other embodiments, thefluid hub202 may be a joint, coupling, or similar connecting device in fluid communication between the elongatefluid members206. Examples of various configurations are described in the following illustrative embodiments.
Each of the elongatefluid members206 may be adapted to communicate fluid between theproximal end212 and thedistal end214 thereof. In some embodiments, theproximal end212 or thedistal end214 of the elongatefluid members206 may be coupled to thefluid hub202. For example, as shown inFIG. 2A, in some embodiments, the plurality of elongatefluid members206 may include a firstelongate fluid member206a, a secondelongate fluid member206b, a thirdelongate fluid member206c, a fourthelongate fluid member206d, and a fifthelongate fluid member206e. Further, in some embodiments, thefluid hub202 may be afirst fluid hub202aand the dressing110 may additionally include asecond fluid hub202b, athird fluid hub202c, and afourth fluid hub202d. Although five of the elongatefluid members206 and four of thefluid hubs202 are shown inFIG. 2A, the dressing110 may include any number of the elongatefluid members206 and thefluid hubs202 as desired.
In some embodiments, thedistal end214 of the firstelongate fluid member206amay be fluidly coupled to thefirst fluid hub202a. Further, theproximal end212 of the secondelongate fluid member206bmay be fluidly coupled to thefirst fluid hub202a. Theproximal end212 of the firstelongate fluid member206amay be in fluid communication with thedistal end214 of the secondelongate fluid member206bthrough thefirst fluid hub202a. In some embodiments, thepneumatic connector106 may be fluidly coupled at theproximal end212 of the firstelongate fluid member206a. Thus, thepneumatic connector106 may provide fluid communication through or along the length of both the firstelongate fluid member206aand the secondelongate fluid member206b. In other embodiments, thepneumatic connector106 and thefluid hub202 may each be fluidly coupled to opposite ends of one of the elongatefluid members206.
Additional elongatefluid members206 may be added in an analogous manner. For example, thedistal end214 of the secondelongate fluid member206bmay be fluidly coupled to thesecond fluid hub202b. Further, theproximal end212 of the thirdelongate fluid member206cmay be fluidly coupled to thesecond fluid hub202b. Theproximal end212 of the secondelongate fluid member206bmay be in fluid communication with thedistal end214 of the thirdelongate fluid member206cthrough thesecond fluid hub202b. Adding additional elongatefluid members206, thedistal end214 of the thirdelongate fluid member206cmay be fluidly coupled to thethird fluid hub202c. Further, theproximal end212 of the fourthelongate fluid member206dmay be fluidly coupled to thethird fluid hub202c. Theproximal end212 of the thirdelongate fluid member206cmay be in fluid communication with thedistal end214 of the fourthelongate fluid member206dthrough thethird fluid hub202c. Adding yet additional elongatefluid members206, thedistal end214 of the fourthelongate fluid member206dmay be fluidly coupled to thefourth fluid hub202d. Further, theproximal end212 of the fifthelongate fluid member206emay be fluidly coupled to thefourth fluid hub202d. Theproximal end212 of the fourthelongate fluid member206dmay be in fluid communication with thedistal end214 of the fifthelongate fluid member206ethrough thefourth fluid hub202d.
Thus, thepneumatic connector106 may be fluidly coupled at theproximal end212 of the firstelongate fluid member206aand in fluid communication with thedistal end214 of the fifthelongate fluid member206ethrough the length of each of the elongatefluid members206a,206b,206c,206d,206e. Thus, in some embodiments, an end of one of the elongatefluid members206 may be fluidly coupled to an end of another of the elongatefluid members206 through thefluid hub202. Further, in some embodiments, theelongate side216 of the elongatefluid members206 may be fluidly sealed to preclude fluid communication through theelongate side216. Other embodiments are possible.
Thefluid hub202 and the plurality ofelongate members206 may be sized or adapted to be positioned at thetissue site116. In embodiments of thetissue site116 including theabdominal cavity124, thefluid hub202 may be positioned adjacent to, against, or supported by theabdominal contents126, while the elongatefluid members206 may be positioned at the firstparacolic gutter128 or the secondparacolic gutter130. Other embodiments are possible. Further, in some embodiments, more than one dressing110 may be positioned at thetissue site116 as desired. Further, the dressing110 may be made visible at thetissue site116 under X-ray, for example, by adding a radiopaque stripe or impregnating the dressing110 with a radiopaque material such as barium.
Referring toFIGS. 2A-2B, in some embodiments, the elongatefluid members206 may include at least onefluid lumen230 positioned between theproximal end212 and thedistal end214 thereof. In some embodiments, thefluid lumen230 may be positioned longitudinally in fluid communication between theproximal end212 and thedistal end214. Further, thefluid lumen230 may extend substantially parallel to theelongate side216 and theseparable joint210.
In some embodiments, thefluid lumen230 may be defined by at least a portion of adressing film234. Thedressing film234 may be comprised of a liquid impermeable material. In some embodiments, thedressing film234 may comprise a non-adherent material, such as a medical drape, which may be capable of inhibiting tissue from adhering to thedressing film234. In some embodiments, thedressing film234 may comprise a breathable polyurethane film. Further, in some embodiments, dressingfilm234 may comprise any of the materials recited above for the sealingmember108.
In some embodiments, thedressing film234 may include two outer layers, such as afirst dressing film236 and asecond dressing film238. Thefluid lumen230 may be defined between thefirst dressing film236 and thesecond dressing film238. For example, thefirst dressing film236 may be folded or pleated with a bellows or accordion profile to form thefluid lumen230, and coupled to thesecond dressing film238 on opposing sides of thefluid lumen230. Thefirst dressing film236 may be coupled to thesecond dressing film238 in any suitable manner, such as, for example, by theweld151. Theweld151 may be continuous or discontinuous, and may be positioned at the top and the bottom of the dressing110 for the orientation shown inFIG. 2A. In other non-limiting embodiments, thefirst dressing film236 may be coupled to thesecond dressing film238 with other suitable coupling devices such as adhesives or cements. Thefirst dressing film236 and thesecond dressing film238 may each be comprised of a liquid impermeable material, or any of the materials recited above for thedressing film234.
Further, in some embodiments, a plurality offenestrations242 may be disposed through thedressing film234. For example, thefenestrations242 may be disposed through at least one of thefirst dressing film236 and thesecond dressing film238 in fluid communication with thefluid lumen230.
In some embodiments, thefluid lumen230 may carry at least of portion of adressing manifold246. The dressingmanifold246 may be disposed in thefluid lumen230. Further, thedressing film234, such as thefirst dressing film236 and thesecond dressing film238, may surround thedressing manifold246. In some embodiments, the dressingmanifold246 may comprise foam or any of the materials recited above for thebridge manifold164.
Thepneumatic connector106 may be in fluid communication with thefluid lumen230 and thedressing manifold246 through the dressingaperture220. For example, thebridge manifold164 of thebridge158 may be positioned proximate to thedressing manifold246 through the dressingaperture220 and in fluid communication with thefluid lumen230 and thedressing manifold246. The dressingaperture220 may be disposed through thefirst dressing film236 or thesecond dressing film238.
Continuing withFIGS. 2A-2B, the separable joint210 may be, for example, carried by, positioned on, or disposed through a portion of thedressing film234, such as thefirst dressing film236 and thesecond dressing film238. Thefirst dressing film236 may be coupled in any suitable manner to thesecond dressing film238 around the separable joint210 at theelongate side216 of the elongatefluid members206, for example, by theweld151. In some embodiments, theweld151 may be continuous or configured to sealingly couple thefirst dressing film236 to thesecond dressing film238. Thus, in some embodiments, theweld151 may preclude fluid communication through theelongate sides216 before and after separation of the elongatefluid members206 from one another at theseparable joint210. In other embodiments, theweld151 may be discontinuous or configured to permit fluid communication through the elongate sides216.
The separable joint210 and the dressing110 may be moveable from a coupled state to a separated state.FIG. 2A depicts the separable joint210 and the dressing110 in the coupled state with theelongate side216 of the elongatefluid members206 releasably coupled to one another. As illustrated in the example ofFIG. 2A, some embodiments of the dressing110 may include the elongatefluid members206 coupled end-to-end through one or more of thefluid hubs202, while the separable joint210 retains the relative positions of the elongatefluid members206 in the coupled state. For example, the separable joint210 may retain the elongatefluid members206 parallel to one another in a coupled state.FIG. 3 depicts the separable joint210 and the dressing110 in the separated state with theelongate side216 of the elongatefluid members206 released or separated from one another. In the separated state, the elongatefluid members206 may be coupled to one another end-to-end, changing the shape or footprint of the dressing110 to an elongate or ribbon-like shape, which can facilitate removal of the dressing110 through a minimally invasive exit point.
Referring toFIG. 3, when the dressing110 is positioned at thetissue site116, for example, a pullingforce250 applied at theproximal end212 of the firstelongate fluid member206amay separate at least one of the elongatefluid members206 from another of the elongatefluid members206, positioning the separable joint210 in the separated state. The separable joint210 may enhance the ability of the dressing110 to cover a larger surface area at thetissue site116. Further, the separable joint210 may enhance removal of the dressing110 from thetissue site116 in a less invasive manner, for example, by changing the shape or footprint of the dressing110 such that each of the elongatefluid members206 may be removed from thetissue site116 sequentially or one at a time. Such a configuration may provide for removal of the dressing110 from thetissue site116 through theexternal opening117 without requiring further surgery, an additional incision, or re-opening of thetissue site116 after the dressing110 has been positioned at thetissue site116 for treatment. For example, the pullingforce250 may be applied to thepneumatic connector106 from exterior to thetissue site116. Thepneumatic connector106 may transfer the pullingforce250 through theexternal opening117 proximate to or about the dressingaperture220, which may be positioned at theproximal end212 of the firstelongate fluid member206a, thereby moving the separable joint210 and the dressing110 to the separated state.
Referring toFIG. 4A, depicted is another illustrative embodiment of a dressing410 suitable for use with thesystem102. Similar to the dressing110, the dressing410 may include thefluid hub202, the plurality of elongatefluid members206, and theseparable joint210. However, as shown inFIG. 4A, theproximal end212 of each of the elongatefluid members206 may be coupled to asingle fluid hub202. Further, each of the elongatefluid members206 may use asingle fluid lumen230 as shown inFIG. 4. In other embodiments, each of the elongatefluid members206 may include any number of thefluid lumens230 as desired. Similar to the dressing110, the dressing410 may also include thedressing manifold246 positioned in thefluid lumen230 and thefluid hub202 of thedressing410.
Thepneumatic connector106, described above inFIG. 1, may be positioned or coupled in fluid communication with the dressing410 and the elongatefluid members206 through the dressingaperture220. In the embodiment ofFIG. 4A, the dressingaperture220 and thepneumatic connector106 may be positioned at thefluid hub202. Thus, each of the elongatefluid members206 may extend longitudinally outward from thefluid hub202 and thepneumatic connector106.
Referring toFIGS. 4A-4B, the dressing410 may include thefirst dressing film236 sealingly coupled to thesecond dressing film238 around the separable joint210 at theelongate side216 of the elongatefluid members206, for example, by theweld151.FIGS. 4A and 4B depict the separable joint210 and the dressing410 in the coupled state with theelongate side216 of the elongatefluid members206 releasably coupled to one another.FIG. 5A depicts the separable joint210 and the dressing410 in the separated state with theelongate side216 of the elongatefluid members206 released or separated from one another. When theseparable joint210 of the dressing410 is in the separated state, thedistal end214 of the elongatefluid members206 may be moveable relative to one another and capable of fanning out into a mop-like shape. Such a configuration may permit the dressing410 to be positioned at thetissue site116 over a larger surface area, or provide for selective positioning of the elongatefluid members206 in a desired location at thetissue site116.
FIG. 5B depicts the pullingforce250 being applied at thefluid hub202 of the dressing410, illustrating the dressing410 and the elongatefluid members206 in a folded and gathered state suitable for removal from thetissue site116 through theexternal opening117. Such a configuration may enhance removal of the dressing410 from thetissue site116 in a less invasive manner, for example, without requiring further surgery or re-opening of thetissue site116 after the dressing410 has been positioned at thetissue site116 for treatment. For example, the pullingforce250 may be applied to thepneumatic connector106, coupled at thefluid hub202, from exterior to thetissue site116. Thepneumatic connector106 may transfer the pullingforce250 through theexternal opening117 proximate to thefluid hub202 and about the dressingaperture220, positioning thedressing410 and the elongatefluid members206 in the folded and gathered state for removal.
Referring generally toFIGS. 1-5B, in some illustrative embodiments of operation of thesystem102, the dressing110,410 may be disposed at or within thetissue site116, such as theabdominal cavity124. The dressing110,410 may be positioned adjacent to or in contact with thetissue site116. In some embodiments, at least one of the elongatefluid members206 of the dressing110,410 may be positioned in, proximate to, or in contact with the firstparacolic gutter128 or the secondparacolic gutter130. Further, in some embodiments, the elongatefluid members206 may be positioned at thetissue site116 with theelongate side216 of the elongatefluid members216 being coupled to one another. For example, the dressing110,410 may be positioned at thetissue site116 in the coupled state described above.
In other embodiments, at least one of the elongatefluid members206 may be separated from another of the elongatefluid members206 prior to or during deployment of the dressing110,410 at thetissue site116. In this manner, theelongate side216 of at least one of the elongatefluid members206 may be separated from theelongate side216 of another of the elongatefluid members206 and spread out or positioned across thetissue site116 to cover a larger surface area, or a particular area that may be desired for treatment.Additional dressings110,410 may be used and positioned as desired, for example, on opposite sides of theabdominal contents126. When deployed, the dressing110,410 may cover all exposed viscera and may separate the viscera from contact with the walls of theabdominal cavity124. The dressing110,410 may be sized and shaped to permit such coverage.
The sealingmember108 may be positioned and fluidly sealed about thetissue site116 with the adhesive172 as described above. Thetissue site116 may be closed around the dressing110,410 to form theexternal opening117. Thepneumatic connector106 may be accessible through theexternal opening117 of thetissue site116 for connection to thetherapy device104 or other components.
Activating the reduced-pressure source136 may provide reduced pressure to thetissue site116 through thepneumatic connector106 and the dressing110,410. When the reduced-pressure source136 is activated, the dressing110,410 may distribute the reduced pressure to thetissue site116 through thefluid hub202 and the elongatefluid members206. The reduced pressure may be distributed to thetissue site116 through the dressingapertures242 that may be associated with thefluid hub202 and the elongatefluid members206, for example. Fluid from thetissue site116 may be communicated from the dressing110,410 to thecanister138 through thepneumatic connector106. When under reduced pressure, the dressingmanifold246 may keep thefluid lumen230 open and in communication with thetissue site116.
After thetissue site116 has been closed around the dressing110,410, the dressing110,410 may be removed from thetissue site116 post-operatively in a non-invasive or less invasive manner with minimal surgical implications. For example, theexternal opening117 at thetissue site116 may have a length or diameter greater than about 6 millimeters. In some embodiments, theexternal opening117 may have a length or diameter between about 6 millimeters to about 10 millimeters, and in some embodiments, about 8 millimeters. Thepneumatic connector106 may be accessed through or at theexternal opening117, and the dressing110,410 may be removed or pulled from thetissue site116 by, for example, applying the pullingforce250 to thepneumatic connector106 or other components of the dressing110,410 through theexternal opening117.
Continuing generally withFIGS. 1-5B, further described are illustrative methods for treating thetissue site116. In some illustrative embodiments, a method for treating thetissue site116 may include providing the dressing110,410. The dressing110,410 may include the plurality of elongatefluid members206 and thepneumatic connector106. The elongatefluid members206 may include theproximal end212, thedistal end214, and theelongate side216 between theproximal end212 and thedistal end214. Thepneumatic connector106 may be positioned in fluid communication with the elongatefluid members206. Further, the method may include positioning the elongatefluid members206 across thetissue site116, and positioning thepneumatic connector106 through theexternal opening117 of thetissue site116. Further, the method may include moving a fluid from thetissue site116 along the elongatefluid members206 to thepneumatic connector206, and extracting the fluid through thepneumatic connector106.
Further, the method may include removing the elongatefluid members206 from thetissue site116 through theexternal opening117 by applying a removal force to thepneumatic connector106. In some embodiments, the removal force may be directed away from thetissue site116. The removal force may include the pullingforce250. Further, in some embodiments, the method may include pulling the dressing110,410 from thetissue site116 by thepneumatic connector106.
In some embodiments, thetissue site116 may be theabdominal cavity124, and positioning the plurality of elongatefluid members206 across thetissue site116 may include placing at least one of the elongatefluid members206 proximate to a paracolic gutter, such as the firstparacolic gutter128 or the secondparacolic gutter130, of theabdominal cavity124. Further, in some embodiments, the method may include sealing theexternal opening117 of thetissue site116 at or about thepneumatic connector106 of thedressing110.
Referring toFIGS. 1-3, in some embodiments, removing elongatefluid members206 from thetissue site116 may include removing each of the elongatefluid members206 through theexternal opening117 one at a time. In some embodiments, removing the elongatefluid members206 from thetissue site116 may include separating the separable joint210 between at least one of the elongatefluid members206 and another of the elongatefluid members206. In some embodiments, the separable joint210 may be separated between at least one of the elongatefluid members206 and another of the elongatefluid members206 from exterior to thetissue site116. In some embodiments, the separable joint210 may be separated between at least one of elongatefluid members206 and another of the elongatefluid members206 from exterior to thetissue site116 when the removal force is applied to thepneumatic connector106.
Referring toFIGS. 1 and 4A-5B, in other embodiments, removing the plurality of elongatefluid members206 from thetissue site116 may include removing more than one of the elongatefluid members206 through theexternal opening117 at the same time. In other embodiments, positioning the elongatefluid members206 across thetissue site116 may include separating the separable joint210 between at least one of the elongatefluid members206 and another of the elongatefluid members206, and spacing theelongate side216 of at least one of the elongatefluid members216 apart from theelongate side216 of another of the elongatefluid members206. In other embodiments, removing the elongatefluid members206 from thetissue site116 may include gathering theelongate side216 of each of the elongatefluid members206 together, and removing more than one the of elongatefluid members206 through theexternal opening117 at the same time. In other embodiments, gathering theelongate side216 of each of the elongatefluid members206 together may occur when the removal force is applied to thepneumatic connector106 from exterior to thetissue site116.
The systems, apparatuses, and methods described herein may provide significant advantages. Among other advantages, some embodiments may substantially reduce complications of trauma to the abdomen. For example, abdominal compartment syndrome (ACS) is a complication of trauma and some medical septic patients that has very high mortality and morbidity. Surgical decompression remains an important intervention. Decompression is achieved by opening the midline fascia along its full length. While this can result in improved physiologic response, the outcomes are not necessarily good. The open abdomen patient may be difficult to manage, susceptible to severe complications, and can require very long stays in an intensive care unit. The cost of treating these patients can be high, at least in part because of extremely long stays in a medical facility while the abdomen remains open. Further, additional complications can arise from ACS, such as kidney failure, which can result in very expensive adjunct therapies. Some of the embodiments described herein allow an abdomen to be closed with a dressing left in place to distribute negative pressure over a large manifolding area of the cavity, and the dressing can removed after treatment through a single exit point rather than the main incision of an open abdomen. The size and shape of some embodiments may also be customizable. Additionally or alternatively, some embodiments may also allow fluid drainage to be customized by location, and fluid removal may be maximized.
Although this specification discloses advantages in the context of certain illustrative, non-limiting embodiments, various changes, substitutions, permutations, and alterations may be made without departing from the scope of the appended claims. For example, a dressing such as the dressing110 or the dressing410 may be tapered toward an exit point to further facilitate removal. Further, any feature described in connection with any one embodiment may also be applicable to any other embodiment.