HK1160044A - Modular, reduced-pressure, wound-closure systems and methods - Google Patents

Abstract

A modular, reduced-pressure, wound-closure system for providing a closing force on a surface would includes a flexible strap operable to be formed into a closed loop inbound and around the surface wound and a plurality of modular closing members coupled to the flexible strap. A reduced-pressure source is fluidly coupled to the plurality of modular closing members. The modular closing members are operable to generate a closing force on the surface wound. A portion of the modular closing members are releasably attached to the patient's epidermis proximate the surface wound and another portion are attached to the flexible strap. A reduced pressure from the reduced-pressure source is delivered to each modular closing member to generate the closing force on the surface wound. Methods and other systems are presented.

Description

Modular reduced-pressure wound closure systems and methods

RELATED APPLICATIONS

In accordance with american code title 35, clause 119 (e), the present invention claims the benefits of the concourse of the following patents: U.S. provisional patent application Ser. No. 61/109,410, entitled "Reduced-pressure, Wound-Closure System and Method", filed on 29.10.2008; U.S. provisional patent application Ser. No. 61/109,486, entitled "Reduced-Pressure, Absolute Treatment System and Method", filed on 29.10.2008; U.S. provisional patent application Ser. No. 61/109,390, entitled "Open-Capity, Reduced-Pressure Wound driving and System", filed on 29.10.2008; and U.S. provisional patent application Ser. No. 61/109,448, entitled "Reduced-Pressure, Deep-Tissue Closure System and Method", filed on 29.10.2008. All of these provisional applications are hereby incorporated by reference for all purposes.

Background

The present invention relates generally to medical treatment systems, and more particularly to a modular, reduced-pressure, wound-closure system and method.

Whether the cause of the wound or damaged area of tissue is trauma, surgery, or other cause, proper care of the wound is important to the outcome. There is a unique challenge when the wound involves a site that requires re-entry, such as the peritoneal cavity and more usually the abdominal cavity. Many times, when surgery or trauma involves the abdominal cavity, establishing a wound management system that facilitates re-entry allows for better and easier care and helps to address situations such as peritoneum, Abdominal Compartment Syndrome (ACS), and infections that may inhibit eventual healing of the wound and internal organs. In providing such care, it may be desirable to remove unwanted fluids from the cavity, help access to fascia and other tissue, and ultimately help provide a closing force on the wound itself at the level of the epidermis. As used herein, "or" does not require mutual exclusivity unless otherwise indicated.

Currently, the epidermal opening on the abdomen can be closed with sutures, staples, clips, and other mechanical devices that allow holding and pulling the skin. Such devices often create puncture wounds or other wounds. Furthermore, if severe edema occurs, a large amount of pressure may be exerted on the closure device and the pressure may cause injury. For example, if pressure rises due to edema, the seam may tear.

A number of techniques have been developed with respect to the entire system that allows re-entry into the abdominal cavity. One method is to place a surgical drape in the cavity and then close the skin over the surgical drape using a clamp such as a hemostat. Although simple and quick, the results are not the most satisfactory. Another method is the so-called "Bogota bag". In this way, the pouch is sewn into place to cover the open abdomen to provide a barrier. Yet another method, sometimes referred to as "vac pack," is to fill a surgical drape in the wound, then place the drain in the abdomen and cover the abdomen with a drape. Finally, reduced pressure methods have been employed. This method is shown in U.S. patent No. 7,381,859 to Hunt et al and assigned to KCI Licensing, inc, San Antonio, texas. U.S. patent No. 7,381,859 is hereby incorporated by reference for all purposes.

SUMMARY

The problems with existing wound closure devices and reduced pressure treatment systems are addressed by the systems, devices, and methods of the exemplary embodiments described herein. According to an exemplary embodiment, a modular, reduced-pressure, wound-closure system includes: a flexible band operable to form a closed loop; and a plurality of modular closure members selectively connected to the flexible band. Each of the plurality of modular closure members includes an attachment member, a sealed contracting member, and a connecting member. Each attachment member is for releasable attachment to a portion of the patient's epidermis proximate the edge of the surface wound and a portion of the sealed contracting member. Each sealed contracting member is operable to contract under reduced pressure. Each connecting member is connected to a respective sealed contracting member and is operable to be selectively connected to the flexible band. Each modular closure member further includes a reduced-pressure interface fluidly connecting the sealed contracting members for delivering a reduced pressure to the sealed contracting members. The modular reduced-pressure wound closure system also includes a reduced-pressure source fluidly connected to each reduced-pressure interface of each of the plurality of modular closure members.

According to another exemplary embodiment, a method of manufacturing a modular, reduced-pressure, wound-closure system includes the steps of: forming a flexible band operable to form a closed loop; and forming a plurality of modular closure members. The step of forming a plurality of modular closure members comprises, for each of the plurality of modular closure members, the steps of: an attachment member for releasable attachment to a portion of the patient's epidermis proximate the edge of the wound and a contracting member forming a seal are formed. The sealed contracting member is operable to contract under reduced pressure. The step of forming a plurality of modular closure members further comprises connecting the second ends of the sealed contracting members to the attachment members and forming a connecting member. A connecting member is operable to selectively connect to the flexible band. The step of forming a plurality of modular closure members further comprises connecting a connecting member to the first end of the sealed contracting member. The exemplary method may also include the step of fluidly connecting a closed reduced-pressure source to the plurality of modular closure members. The closed reduced-pressure source is operable to deliver reduced pressure to each of the plurality of modular closure members.

According to another exemplary embodiment, a method of providing closure force to a surface wound on a patient comprises the steps of: a flexible band operable to form a closed loop is provided and a plurality of modular closure members are provided. The method of providing a closure force further comprises the steps of: the flexible band is shaped into a closed loop proximate the surface wound and a reduced pressure source is provided. The method of providing a closure force further comprises the steps of: the method includes fluidly connecting a reduced pressure source to a plurality of modular closure members and delivering reduced pressure to each of the plurality of modular closure members. The modular closure member generates a closing force when reduced pressure is delivered. In this exemplary embodiment, each of the plurality of modular closure members includes an attachment member for releasable attachment to a portion of the patient's epidermis proximate the edge of the surface wound and a sealed contracting member having a first end and a second end. The second end of the sealed contracting member is connected to the attachment member. The sealed contracting member is operable to contract when placed under reduced pressure. Each of the plurality of modular closure members further includes a connecting member connected to the first end of the sealed contracting member and a reduced-pressure interface fluidly connecting the sealed contracting member for delivering a reduced pressure to the sealed contracting member.

Other objects, features, and advantages of the exemplary embodiments will become apparent with reference to the drawings and the following detailed description.

Brief description of the drawings

Fig. 1 is a schematic cross-sectional view, with portions presented as block diagrams, of a modular, reduced-pressure wound closure and therapy system;

fig. 2 is a schematic perspective view of an exemplary embodiment of a portion of a modular, reduced-pressure, wound-closure system;

fig. 3 is a schematic cross-sectional view of a portion of a modular closure member of the modular reduced-pressure wound closure system of fig. 2;

fig. 4 is a schematic cross-sectional view of the example modular, reduced-pressure wound closure system of fig. 2-3, shown deployed over a surface wound of a patient;

FIG. 5 is a schematic cross-sectional view of an exemplary embodiment of a portion of a modular closure member; and

fig. 6 is a schematic cross-sectional view of an exemplary embodiment of a portion of a modular closure member.

Detailed description of illustrative embodiments

In the following detailed description of the exemplary embodiments, reference is made to the accompanying drawings, which 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 to be 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 present invention. The description may omit certain information known to those skilled in the art, in order to avoid detail not necessary to enable those skilled in the art to practice the invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of exemplary embodiments is defined only by the appended claims.

Referring to fig. 1, an exemplary embodiment of a reduced-pressure wound closure and therapy system 100 is presented. The reduced-pressure wound closure and therapy system 100 may include a reduced-pressure therapy subsystem 102 and a modular reduced-pressure wound closure subsystem 104. The reduced-pressure treatment subsystem 102 may be used to treat a tissue site 106 with reduced pressure. The tissue site 106 may be body tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue. The tissue site 106 may be within a body cavity, such as the abdominal cavity 110, and may include multiple tissue layers, including a wound within the epidermis 108. Treatment with the reduced pressure treatment subsystem 102 may include removing fluids such as ascites or exudates, delivering reduced pressure, or providing a protective barrier.

In an exemplary embodiment, the reduced-pressure wound closure and therapy system 100 is presented in the context of an abdominal cavity 110 and a surface wound 111 having a wound edge 112. Other subcutaneous tissue 114 may also be open, such as adipose tissue, muscle, fascia, and the like. The abdominal cavity 110 is shown with abdominal contents 116 that form a surface or support.

The reduced-pressure treatment subsystem 102 of the reduced-pressure wound closure and treatment system 100 facilitates the delivery of reduced pressure to the tissue site 106 and the abdominal cavity 110. The reduced-pressure treatment subsystem 102 includes a manifold 118 disposed within the abdominal cavity 110 to distribute reduced pressure within the abdominal cavity 110 and to receive fluids. The manifold 118 may include a manifold member 120 or a second manifold within a non-bonded enclosure 122. The non-adhesive surround 122 has apertures 124 on a first side and apertures 126 on an inward-facing (tissue-facing) second side. The apertures 124 and 126 facilitate fluid flow, as indicated by arrows 128. The apertures 124 and 126 may take any shape, such as rectangular openings, circular openings, polygons, slits (elongated slots), and the like. The non-adhesive surround 122 may be formed from a flexible film, such as a polyurethane film, a drape material, or any non-adhesive material.

Reduced pressure may be applied by the reduced pressure treatment subsystem 102 to the abdominal cavity 110 and the tissue site 106 to help facilitate removal of exudates, ascites or other fluids, bacteria, fibrin, dead tissue, toxins, residual blood, and the like. In some cases, reduced pressure may also be used to stimulate the growth of additional tissue. In the case of a wound at the tissue site 106, the growth of granulation tissue and removal of exudate and bacteria may help promote healing of the wound. In the case of non-wounded or non-defective tissue, reduced pressure may be used to promote the growth of tissue that may be harvested and transplanted to another tissue site. In other cases, fluid removal may be the primary reason for applying reduced pressure.

As used herein, "reduced pressure" generally refers to a pressure that is less than the ambient pressure at the tissue site 106. In most cases, this reduced pressure will be less than the atmospheric pressure at the location of the patient. Alternatively, the reduced pressure may be less than the hydrostatic pressure at the tissue site 106. Unless otherwise indicated, the pressure values described herein are gauge pressures.

Manifold 118 and manifold member 120 are disposed within abdominal cavity 110 and may be disposed at or near tissue site 106. The non-adhesive enclosure 122 containing the manifold member 120 is generally disposed against the tissue site 106, and in particular proximate the abdominal contents 116. The manifold 118 is disposed adjacent to the unbonded enclosure 122. Manifold 118 and manifold member 120 may take many forms. As used herein, the term "manifold" generally refers to a substance or structure provided to assist in applying reduced pressure to, delivering fluids to, or removing fluids from a tissue site, such as tissue site 106. Manifold 118 and manifold member 120 generally include a plurality of fluid channels or paths that distribute or remove provided fluids to or from areas proximate to manifold 118 and manifold member 120. In one embodiment, the manifold 118 and the manifold member 120 generally include a plurality of fluid channels or pathways that are interconnected to improve the distribution of fluids. The manifold 118 and manifold member 120 may be formed from biocompatible materials that can be placed in contact with tissue and distribute reduced pressure. Examples of manifolds may include, but are not limited to, devices having structural elements arranged to form flow channels, porous foams such as open-cell foams, porous tissue connective, and liquids, gels, and foams that include or cure to include flow channels.

The manifold 118 and manifold member 120 may be porous and may be made of foam, gauze, felt pads, or any other material suitable for a particular biological application. In one embodiment, the manifold 118 and the manifold member 120 are made of porous foam that includes a plurality of interconnected cells or pores that function as flow channels. The porous foam may be polyurethane, open cell foam, reticulated foam, such as the GranuFoam manufactured by Kinetic Concepts, Inc. of San Antonio, TexA material. Other embodiments may include "closed cells". In some cases, the manifold 118, the manifold member 120, and the non-adhesive enclosure 122 may be used to distribute fluids, such as drugs, antimicrobials, growth factors, and other solutions, to the tissue site 106. Other layers may be included as part of the manifold 118 and manifold member 120, such as absorbent materials, wicking materials, hydrophobic materials, hydrophilic materials, and the like.

The sealing member 132 may be placed over the surface wound 111 in the epidermis 108, and in particular is made to cover the wound edge 118 to provide a pneumatic seal. Thus, the sealing member 132 provides a seal over the manifold 118 and the unbonded enclosure 122. The sealing member 132 may be a cap that is used to secure the manifold 118 and the non-adhesive surround 122 at the tissue site 106. While the sealing member 132 may be impermeable or semi-permeable, the sealing member 132 is capable of maintaining a reduced pressure at the tissue site 106 upon installation of the sealing member 132 onto the manifold 118. The sealing member 132 may be a flexible drape or film formed from a silicone-based compound, acrylic, hydrogel or hydrogel-forming material, or any other biocompatible material that includes the desired impermeability or permeability characteristics of the intended tissue site.

The sealing member 132 may also include an attachment device 136 to secure the sealing member 132 to the patient's epidermis 108. The attachment device 136 may take many forms, for example, a sealing band may be used, or an adhesive 134 may be provided along the outer perimeter of the sealing member 132 or any portion of the sealing member 132 to provide a pneumatic seal. The adhesive 134 may also be pre-applied and covered with a releasable member (not shown) that is removed when applied.

A first reduced-pressure interface 138, such as a port 140 or connector, may be used to deliver reduced pressure from a first reduced-pressure delivery conduit 142 to the manifold 118. The first reduced-pressure interface 138 may also communicate any exudates, ascites, or other fluids from the manifold 118. The reduced pressure within the manifold 118 pulls fluid in the direction indicated by arrow 144 and to the first reduced-pressure delivery conduit 142. The first reduced-pressure interface 138 allows fluid to pass from the manifold 118 to the first reduced-pressure delivery conduit 142. For example, fluid collected from the tissue site 106 using the manifold member 120 and the manifold 118 may enter the first reduced-pressure delivery conduit 142 via the first reduced-pressure interface 138. In another embodiment, the reduced-pressure treatment subsystem 102 may not include the first reduced-pressure interface 138, and the first reduced-pressure delivery conduit 142 may be inserted directly into the sealing member 132 and the manifold 118. The first reduced-pressure delivery conduit 142 may be a medical conduit, a multi-lumen member, a tube, or any other device for delivering reduced pressure.

The reduced-pressure subsystem 148 may be used to supply the reduced pressure delivered to the first reduced-pressure delivery conduit 142. The reduced-pressure subsystem 148 may include a first reduced-pressure unit or source 150 that delivers reduced pressure to a conduit 152, with conduit 152 delivering reduced pressure to a three-way valve 154. A portion of the reduced pressure may exit the three-way valve 154 through a second reduced pressure delivery conduit 156. Another portion of the reduced pressure may exit the three-way valve 154 through a reduced pressure conduit 158. Any number of devices may be disposed on the reduced-pressure conduit 158, such as a reduced-pressure feedback unit 160, which may provide feedback regarding the regulation of the reduced pressure within the reduced-pressure conduit 158, for example, to the three-way valve 154. The reduced-pressure conduit 158 delivers reduced pressure to the canister 162, and the canister 162 is operable to contain any fluid delivered from the tissue site 106 to the canister 162. The reduced pressure exiting canister 162 is communicated to a first reduced-pressure delivery conduit 142. The first reduced-pressure delivery conduit 142 may be referred to as delivering a therapeutic reduced pressure because the reduced pressure therein has been placed at a desired pressure and condition by the reduced-pressure subsystem 148 for use in reduced-pressure treatment at the tissue site 106. The reduced pressure delivered to the first reduced-pressure delivery conduit 142 is typically selected to be in the range of-50 mm Hg to-500 mm Hg, and more typically in the range of-100 mm Hg to-300 mm Hg at the tissue site 106.

A number of different devices, such as device 166, may be added to the intermediate portion 164 of the first reduced-pressure delivery conduit 142. The device 166 may be a pressure feedback device, a volume detection system, a blood detection system, an infection detection system, a flow monitoring system, a temperature monitoring system, or the like. Some of these devices may be integrally formed with other components; for example, the tank 162 may include one or more filters, such as a hydrophobic filter that prevents liquid from exiting.

There are many ways to generate or supply reduced pressure for use with the reduced-pressure wound closure and treatment system 100. In the exemplary embodiment shown, the first reduced-pressure unit 150 is used for two applications, namely, for wound closure and for reduced-pressure therapy. In alternative embodiments, it may be desirable to use the first reduced-pressure unit 150 as a source of the second reduced-pressure delivery conduit 156 and have the second reduced-pressure unit 151 (shown in phantom) deliver reduced pressure to the reduced-pressure conduit 158.

As an aspect of the reduced-pressure wound closure and therapy system 100, it is also desirable to help provide a closing force to the surface wound 111 and in particular to apply the closing force between the wound edges 112. As shown in fig. 1, a modular, reduced-pressure wound-closure subsystem 104 may be used for this purpose. The modular reduced-pressure wound-closure subsystem 104 generates a closure force represented by arrow 170. The closing force is transferred to the epidermis 108 and pushes the wound edges 112 towards each other. The modular reduced-pressure wound-closure subsystem 104 may be a stand-alone system for closing any surface wound or used as part of a larger system, such as the reduced-pressure wound-closure and therapy system 100.

The modular, reduced-pressure, wound-closure subsystem 104 includes a spacing member, such as a flexible band 171, shaped as a closed loop inside the wound edge 112 (see, e.g., fig. 4), and a plurality of modular closure members 169 associated with the flexible band 171. Alternatively, the spacer members may be one or more wires that hold the modular closure members 169 in a spaced apart relationship or a flexible adhesive film placed over the top of the modular closure members 169 that holds the modular closure members 169 in a spaced apart relationship. Each modular closure member 169 has a sealed contracting member 195, connecting member 181, and attachment member 211. Prior to forming the closed loop, a plurality of modular closure members 169, such as first modular closure member 173 and second modular closure member 175, are attached to the flexible strap 171. The plurality of modular closure members 169 are similar to the modular closure members 308 of fig. 2. The number of modular closure members 169 included on the flexible strap 171 is determined by the size of the loop required to surround the surface wound 111.

Each modular closure member of the plurality of modular closure members 169 has a first end 177 and a second end 179, the first end 177 being positioned generally inside the surface wound 111 and the second end 179 being positioned generally outside the surface wound 111. Each connecting member 181 is connected to the first end 177 of a respective modular closure member 169. In the exemplary embodiment of fig. 1, each connecting member 181 includes an attachment opening or loop 185 through which the flexible strap 171 may be placed. The attachment loops 185 allow each modular closure member 169 to be disposed in a desired position along the flexible strap 171.

A reduced-pressure interface 186 is connected to each modular connection member 181. A plurality of reduced-pressure conduits 187 are fluidly connected to the reduced-pressure interface 186 to provide reduced pressure thereto. The reduced pressure supplied through the second reduced-pressure delivery conduit 156 is fluidly connected to the distributor 223, the distributor 223 is fluidly connected to a plurality of reduced-pressure conduits 187, and the plurality of reduced-pressure conduits 187 are fluidly connected to a plurality of reduced-pressure interfaces 186 to deliver reduced pressure to each modular closure member 169. For each modular closure member 169, the reduced-pressure interface 186 delivers reduced pressure to the sealed contracting member 195. Each reduced-pressure interface 186 may also function as a pin to hold the respective connecting member 181 in place relative to the flexible belt 171.

Each modular closure member 169 of the modular wound closure subsystem 104 includes a sealing constriction member 195 for generating a closure force. The sealed constriction member 195 may be formed of a constriction manifold material that is the same type of material as the manifold 118. Alternatively, it may be desirable to use a shrink manifold material having fewer holes or voids than the material used for the manifold 118. In addition, it may be desirable to have a material that will shrink to a lesser degree in the vertical direction (for the orientation shown in FIG. 1) and to a greater degree in the horizontal or lateral plane (for the orientation shown in FIG. 1). In an alternative embodiment, the sealed contracting member 195 may be formed using a pneumatic device to generate the closing force. For example, a chamber that collapses under reduced pressure may be used. The sealed contracting member 195 has a first side 190 and an inwardly facing second side 192. The sealed contracting member 195 is sealed to form a pneumatic seal around the interior space of the sealed contracting member 195.

Each connecting member 181 of the plurality of modular closure members 169 includes a base 203 and a wall 209. The base 203 and wall 209 are integrally formed or otherwise attached by any technique such as welding, bonding, gluing, bonding, etc. Each attachment member 211 has a base 213 and a wall 215. The base 213 and the wall 215 of the attachment member 211 are integrally formed or otherwise connected by any technique such as those previously mentioned. Adhesive 197 or other attachment devices may be used to secure the sealed contracting members 195 to the base 203 of the respective connecting member 181. Adhesive 205 or other attachment device may also be used to connect the peripheral edge 207 of the sealed contracting member 195 to the wall 209 of the corresponding connecting member 181. Adhesive 217 or other attachment devices may be used to secure the sealed contracting members 195 to the base 213 of the respective attachment member 211. Adhesive 219 or other attachment device may also be used to secure the sealed contracting members 195 to the walls 215 of the respective attachment members 211. Adhesive 227 or other attachment devices may be used to releasably attach the base 213 to the epidermis 108 (or to the sealing member if already deployed on the epidermis).

In operation, the reduced-pressure wound closure and treatment system 100 may be used within a body cavity, such as the abdominal cavity 110, by first applying a manifold material over the abdominal contents 116. For example, a manifold member 120 having a non-bonded enclosure 122 may be placed over the abdominal contents 116 and the manifold 118 disposed proximate the non-bonded enclosure 122. The wound edges 112 of the surface wound 111 may be gathered to the extent possible and then the sealing member 132 is placed on the epidermis 108 to provide a pneumatic seal over the surface wound 111.

A healthcare worker may measure or estimate the circumference of the surface wound 111 and then utilize a look-up table to determine the number of modular closure members 169, such as the first modular closure member 173, that need to be added to the flexible strap 171. The flexible band 171 is also cut or otherwise sized to an appropriate length. A desired plurality of modular closure members 169, such as modular closure members 173 and 175, are added to the flexible strap 171. The flexible band 171 is formed as a closed loop having a circumference that is less than the circumference of the surface wound 111. The closed loop is located substantially in the center of the surface wound 111 and each attachment member 211 is secured to the patient's epidermis 108 (or sealing member 132). In this regard, as used herein, reference to attachment to the patient's epidermis 108 should be considered to include the sealing member 132 attached to the epidermis 108.

A first reduced-pressure interface 138, which may be a reduced-pressure port 140, may be applied such that the extension 202 enters into the manifold 118. The first reduced-pressure delivery conduit 142 may be connected to the first reduced-pressure interface 138 to provide a fluid connection with the first reduced-pressure unit 150 (or the optional second reduced-pressure unit 151). The second reduced-pressure delivery conduit 156 may be fluidly connected to a distributor 223. A plurality of reduced-pressure conduits 187 are fluidly connected to the distributor 223 and the plurality of reduced-pressure interfaces 186.

The reduced-pressure wound closure and treatment system 100 is activated such that the first reduced-pressure unit 150 delivers reduced pressure through the three-way valve 154 in preparation for the therapeutic reduced pressure delivered to the first reduced-pressure delivery conduit 142 and the closed reduced pressure delivered to the second reduced-pressure delivery conduit 156. The therapeutic reduced pressure delivered through the first reduced-pressure delivery conduit 142 is achieved at the manifold 118, the manifold 118 drawing fluid and distributing the reduced pressure within the abdominal cavity 110 as indicated by arrows 144 and 128. The closing reduced pressure is delivered to the distributor 223 through a second reduced-pressure delivery conduit 156 and to the plurality of modular closing members 169 through a plurality of reduced-pressure conduits 187. The closing reduced pressure is received by the plurality of modular closing members 169 and transferred to the interior of each sealed contracting member 195, and contracts each sealed closing member 195 and thereby generates a closing force between the flexible strap 171 and the attachment member 211. The net result is a closing force that pushes the wound edges inward.

Referring now to fig. 2-4, an exemplary embodiment of a modular, reduced-pressure, wound-closure system 300 is presented. The modular reduced-pressure wound closure system 300 may be used as the modular reduced-pressure wound closure subsystem 104 of fig. 1. The modular, reduced-pressure, wound-closure system 300 may include a flexible band 302 having a plurality of modular closure members 308. Each modular closure member 308 includes an attachment member 320 and a connecting member 314. The use of modular members 308 allows for accommodation of many sizes and shapes of surface wounds without requiring a large inventory of wound dressings or devices of different sizes and shapes.

The flexible band 302 is shown in a linear position in fig. 2 and is shaped as a closed loop 304 in fig. 4. The flexible band 302 is shaped as a closed loop 304 around a surface wound 306, such as an opening in the patient's epidermis. A plurality of modular closure members 308 are selectively connected to the flexible band 302. The number of modular closure members 308 included on the flexible band 302 is determined by the size of the closed loop 304 required to surround the surface wound 306. Thus, to surround the surface wound 306 in fig. 4, 8 modular closure members 308 are included on the flexible band 302. Referring again to fig. 2, each modular closure member 308 has a first end 310 and a second end 312.

Each connecting member 314 is connected to the first end 310 of each modular closure member 308. In the exemplary embodiment shown in fig. 2, each connecting member 314 includes an attachment loop or opening 316 through which the flexible band 302 may be placed. The attachment loops 316 allow each modular closure member 308 to be positioned at a desired location along the flexible band 302. A portion of each attachment loop 316 may interface with the strap opening 318 to help retain the connecting member 314 in place on the flexible strap 302. Alternatively or additionally, the reduced-pressure interface 326 may function as a tack to hold the connection member 314 in place relative to the flexible band 302.

Referring now primarily to fig. 3, a connecting member 314 is presented. The reduced-pressure interface 326 is shown connected to the connection member 314. A reduced-pressure conduit 327 is fluidly connected to the reduced-pressure interface 326 to provide reduced pressure to the reduced-pressure interface 326. The reduced-pressure interface 326 transfers the reduced pressure to the sealed constriction member 328, and as previously mentioned, the reduced-pressure interface 326 may function as a pin to hold the connection member 314 in place relative to the flexible band 302.

The sealed constriction member 328 is made of the same or similar material as the previously mentioned sealed constriction member 195 of fig. 1. The sealed contracting member 328 is sealed to form a pneumatic seal around an interior space of the sealed contracting member 328. An adhesive 329 or other attachment device (e.g., cement, welding, hooks, etc.) may be used to secure the sealed contracting member 328 to the base 331. Adhesive 335 or other attachment devices (e.g., cement, welding, hooks, etc.) may also be used to attach the peripheral edge 333 of the sealed shrink member 328 to the wall 323 of the connecting member 314.

Referring again primarily to fig. 2, an attachment member 320 may be connected to each of the second ends 312 of the sealed contracting members 328. Each attachment member 320 may be formed with a base 322 and a wall 324. An adhesive (not expressly shown) or other attachment device (e.g., cement, welding, hooks, etc.) may be used to secure the sealed contracting member 328 to the base 322. Adhesive (not expressly shown) or other attachment devices (e.g., cement, welding, hooks, etc.) may also be used to secure the sealed shrink member 328 to the wall 324.

Referring now primarily to fig. 5, an optional reduced-pressure interface 427 is presented as part of the connecting member 416. Reduced pressure may be provided to the sealed contracting member 428 by the connecting member 416. A connecting member 416 is selectively attached to the flexible band 402. An adhesive 430 may be used to secure the sealed contracting member 428 to the connecting member 416. The connecting member 416 may have a wall 424 and a base 422, the wall 424 and the base 422 being integrally formed or otherwise connected by any technique, such as welding (RF welding or ultrasonic welding), bonding, gluing, bonding, or the like. A reduced-pressure interface 427 may be formed on the base 422 and configured to access the manifold 118 or manifold pad. The reduced-pressure interface 427 is sized and configured to engage a manifold 480, the manifold 480 being in fluid communication with or fluidly connected to a reduced-pressure source. The reduced pressure is delivered to a manifold 480, and the manifold 480 delivers the reduced pressure to the sealed contracting member 428 via a reduced-pressure interface 427.

Referring again primarily to fig. 2-4, one exemplary method of operating the modular, reduced-pressure, wound-closure system 300 will be presented. In operation, a healthcare worker evaluates the size of the surface wound 306 and determines the number of modular closure members 308 appropriate for the size of the surface wound 306. A look-up table or look-up table based on measurements of the circumference of the surface wound 306 may be used to suggest a suitable number of modular closure members 308. Next, a suitable number of modular closure members are selectively attached to the flexible band 302. Flexible band 302 is then formed into a closed loop 304, closed loop 304 preferably being sized to be inside the outer peripheral edge of surface wound 306. Any number of means are employed to secure the flexible band 302 to form the closed loop 304, such as ratchets, snaps, fasteners, ratchet tensioners, flexible pin and slot members, and the like. Subsequently, each of the plurality of attachment members 320 is attached to the patient's epidermis proximate the edge of the surface wound 306. As before, the statement that the attachment member 320 is attached to the epidermis may include the attachment member 320 being attached to a sealing member being used for reduced pressure treatment.

Upon application of each attachment member 320, the base 322 may have adhesive (see adhesive 227 of fig. 1) or other attachment device applied on the second, inwardly facing surface 336. The adhesive may have a releasable backing on the adhesive that is removed prior to use. Thus, the healthcare worker would tear the backing, expose the adhesive, and then press the adhesive onto the epidermis (or sealing member). Next, each reduced-pressure interface 326 associated with each of the plurality of connecting members 314 is connected to a reduced-pressure source, for example, by a reduced-pressure conduit 327 or a distributor (not shown). (alternatively, the reduced-pressure interface 427 of FIG. 5 may have been introduced into the manifold 480, if a manifold is used). After activation of the reduced-pressure source, reduced pressure is supplied to the reduced-pressure conduit 327, the reduced-pressure conduit 327 delivering reduced pressure to the sealed constriction member 328 through the reduced-pressure interface 326. The reduced pressure causes the sealed contracting member 328 to contract. When the sealed contracting member 328 contracts, the sealed contracting member 328 generates a closing force represented by arrow 340 in fig. 4. The closed loop 304 remains substantially in the opposite position and thus each attachment member 320 pulls the skin inward.

If reduced-pressure treatment is also desired, the closed loop 304 provides an open area in the middle of the closed loop 304 that readily accommodates the reduced-pressure interface 342. The reduced-pressure interface 342 may be used to supply reduced pressure to a reduced-pressure treatment system (see, e.g., the reduced-pressure treatment subsystem 102 in fig. 1).

Referring now primarily to fig. 5, another alternative exemplary embodiment of a reduced-pressure interface 526 is presented. The reduced-pressure interface 526 is formed as part of the attachment member 520. Attachment member 520 includes a base 522 and a wall 524 that are integrally formed or otherwise connected. An adhesive 530 or other attachment device (e.g., a binder, cement, welding, etc.) may hold or secure a portion of the contracting member 528 to the chassis 522. An adhesive 534 or other attachment device (e.g., a binder, cement, welding, etc.) may hold a portion of the shrink member 528 to the wall 524. An adhesive 535 or other attachment device (e.g., adhesive, cement, stitching, etc.) on the inward facing side 536 of the chassis 522 may be used to attach the chassis 522 to the patient's epidermis (or sealing member). In this exemplary embodiment, a reduced-pressure interface 526 fluidly connected to a reduced-pressure conduit 527 extends through the wall 524 and delivers reduced pressure to a sealed constriction member 528.

Referring again to fig. 4, another embodiment will be presented. In this alternative embodiment, a set number of modular closure members 308 are slidably attached to the strap 302 and may be disposed as such in a closed toolbox. When applying the wound closure system 300, a healthcare worker properly separates a set number of modular closure members 308-generally equidistant from each other-over a portion of the band 302 to be used and forming a closed loop 304. Any additional portions of the band 302, i.e., portions that are not required to form a closed loop, may be cut or removed.

According to another exemplary embodiment, a modular wound closure system for closing a wound on a patient's epidermis using reduced pressure includes a plurality of closure devices that contract when affected by reduced pressure. Each closure device has a distal end and a proximal end. The system also includes a flexible member for maintaining the plurality of closure devices in a spaced apart relationship with the proximal end inboard of the wound edge. The system also includes a plurality of attachment devices for releasably connecting distal ends of the plurality of closure devices to an outer surface of a wound margin of a patient's epidermisAnd (3) side. The system also includes a plurality of reduced-pressure connectors for providing reduced pressure to the plurality of closure devices. The plurality of closure devices may be formed as a plurality of sealed constriction members. A plurality of closure devices may be removably mated to the flexible member. The plurality of closure devices has a first volume (V) at ambient pressure₁) And has a second volume (V) under reduced pressure₂) And wherein V₁＞V₂. A plurality of closure devices may be slidably mated to the flexible member.

Although the present invention and its advantages have been disclosed in the context of certain exemplary, non-limiting embodiments, it should be understood that various changes, substitutions, alterations, and modifications may be made herein without departing from the scope of the invention as defined by the appended claims.

Claims (27)

1. A modular, reduced-pressure, wound-closure system for providing a closing force to a surface wound, the system comprising:

a flexible band operable to form a closed loop; and

a plurality of modular closure members selectively connected to the flexible band, each of the plurality of modular closure members comprising:

an attachment member for releasable attachment to a portion of the patient's epidermis proximate the margin of the surface wound, the attachment member having a base and a wall,

a sealed contracting member having a first end and a second end, the second end being connected to the attachment member, wherein the sealed contracting member is operable to contract under reduced pressure,

a connecting member connected to the first end of the sealed contracting member, the connecting member being operable to be selectively connected to the flexible band, an

A reduced-pressure interface fluidly connecting the sealed contracting member for delivering a reduced pressure to the sealed contracting member.

2. The modular, reduced-pressure wound closure system of claim 1, further comprising a reduced-pressure source fluidly connected to each reduced-pressure interface of each of the plurality of modular closure members, the reduced-pressure source operable to deliver a reduced pressure to each reduced-pressure interface of the plurality of modular closure members.

3. The modular, reduced-pressure wound closure system of claim 1, further comprising a reduced-pressure source fluidly connected to each reduced-pressure interface of each of the plurality of modular closure members, the reduced-pressure source operable to deliver a reduced pressure to each reduced-pressure interface of the plurality of modular closure members, and wherein for each modular closure member, the reduced-pressure interface is connected to the connection member.

4. The modular, reduced-pressure, wound-closure system of claim 1, further comprising a reduced-pressure source fluidly connected to each reduced-pressure interface of each of the plurality of modular closure members, the reduced-pressure source operable to deliver a reduced pressure to each reduced-pressure interface of the plurality of modular closure members, and wherein for each modular closure member, the reduced-pressure interface is connected to the attachment member.

5. The modular, reduced-pressure, wound-closure system of claim 1, wherein the flexible strap is formed with a plurality of strap openings, and wherein each reduced-pressure interface of each of the plurality of modular closure members is sized and configured to extend through a strap opening.

6. The modular, reduced-pressure, wound-closure system of claim 1, wherein each sealed contracting member comprises a contracting manifold material.

7. The modular, reduced-pressure, wound-closure system of claim 1, wherein:

for each modular closing member, the reduced-pressure interface is connected to the connecting member;

the flexible band is formed with a plurality of band openings, and wherein each reduced-pressure interface of each of the plurality of modular closure members is sized and configured to extend through a band opening; and

each sealed constricting member comprises a constricting manifold material.

8. A method of manufacturing a modular, reduced-pressure, wound-closure system for generating a closure force on a surface wound, the method comprising the steps of:

forming a flexible band operable to be shaped into a closed loop; and

forming a plurality of modular closure members, wherein the step of forming a plurality of modular closure members comprises, for each of the plurality of modular closure members, the steps of:

forming an attachment member for releasable attachment to a portion of a patient's epidermis proximate a margin of the surface wound,

forming a sealed contracting member having a first end and a second end, wherein the sealed contracting member is operable to contract under reduced pressure,

connecting the second end of the sealed contracting member to the attachment member, forming a connecting member operable to selectively connect to the flexible band, an

Connecting the connecting member to the first end of the sealed contracting member.

9. The manufacturing method according to claim 8, further comprising:

fluidly connecting a reduced-pressure interface to the sealed contracting member of each modular closure member to deliver a reduced pressure to the sealed contracting member.

10. The manufacturing method according to claim 8, further comprising the steps of:

providing a closed reduced pressure source; and

fluidly connecting the closed reduced-pressure source to each reduced-pressure interface of the plurality of modular closure members, the closed reduced-pressure source operable to deliver a reduced pressure to each reduced-pressure interface of the plurality of modular closure members.

11. The manufacturing method of claim 9, wherein the step of fluidly connecting a reduced-pressure interface to the sealed constriction member includes connecting a reduced-pressure interface to the connection member.

12. The manufacturing method of claim 9, wherein the step of fluidly connecting a reduced-pressure interface to the sealed contraction member includes connecting a reduced-pressure interface to the attachment member.

13. The method of manufacturing as defined in claim 8, wherein the step of forming a flexible strip includes the step of forming a flexible strip having a plurality of strip openings.

14. The method of manufacturing as claimed in claim 8, wherein the step of forming a sealed shrink member includes the step of forming a sealed shrink member comprising a shrink manifold material.

15. The manufacturing method according to claim 9, wherein:

the step of fluidly connecting the reduced-pressure interface to the sealed contracting member comprises connecting the reduced-pressure interface to the connecting member;

the step of forming the flexible band includes forming the flexible band with a plurality of band openings; and

the step of forming a sealed shrink member includes the step of forming a sealed shrink member comprising a shrink manifold material.

16. A method of treating a surface wound on a patient, the method comprising the steps of:

providing a spacing member;

providing a plurality of modular closure members, each of the plurality of modular closure members comprising:

an attachment member for releasable attachment to a portion of the patient's epidermis proximate the margin of the surface wound, the attachment member having a base and a wall,

a sealed contracting member having a first end and a second end, the second end being connected to the attachment member, wherein the sealed contracting member is operable to contract when placed under reduced pressure,

a connecting member connected to the first end of the sealed contracting member, the connecting member being operable to selectively connect to the spacing member, an

A reduced-pressure interface fluidly connected to the sealed contracting member for delivering a reduced pressure to the sealed contracting member;

connecting the plurality of modular closure members on the spacer member;

placing the spacing member proximate the surface wound such that the plurality of modular closure members are spaced apart around the surface wound;

providing a reduced pressure source;

fluidly connecting the reduced-pressure source to each of the reduced-pressure interfaces of the plurality of modular closure members; and

communicating a reduced pressure to each reduced-pressure interface of the plurality of modular closure members, whereby each modular closure member generates a closing force.

17. The method of treating a surface wound on a patient according to claim 16, wherein the spacing member comprises a flexible band.

18. The method of treating a surface wound on a patient according to claim 16, further comprising providing reduced pressure to the body cavity.

19. The method of treating a surface wound on a patient according to claim 16, further comprising providing reduced pressure from the reduced-pressure source to a body cavity.

20. The method of treating a surface wound on a patient according to claim 16, wherein the step of fluidly connecting the reduced-pressure source comprises connecting a reduced-pressure conduit to the reduced-pressure interface.

21. The method of treating a surface wound on a patient according to claim 16, wherein for each of the plurality of modular closure members, the reduced-pressure interface is connected to the connection member.

22. A method of treating a surface wound on a patient according to claim 16, wherein the step of providing a spacing member comprises providing a flexible strip formed with a plurality of strip openings.

23. The method of treating a surface wound on a patient according to claim 16, wherein each sealed contracting member of the plurality of modular closing members comprises a contracting manifold material.

24. A modular wound closure system for closing a wound on a patient's epidermis with reduced pressure, the system comprising:

a plurality of closure devices that contract when affected by reduced pressure, each closure device having a distal end and a proximal end;

a flexible member for holding the plurality of closure devices in a spaced apart relationship with the proximal end inboard of the wound edges;

a plurality of attachment devices for releasably connecting the distal ends of the plurality of closure devices to a patient's epidermis outside of the margins of the wound; and

a plurality of reduced-pressure connectors to provide reduced pressure to the plurality of closure devices.

25. The wound closure system of claim 24, wherein the plurality of closure devices comprise a plurality of sealed contracting members, and wherein the plurality of closure devices are detachably mated to the flexible member.

26. The wound closure system of claim 24, wherein the plurality of closure devices have a first volume (V) at ambient pressure₁) And has a second volume (V) under reduced pressure₂) And wherein V₁＞V₂。

27. The wound closure system of claim 24, wherein the plurality of closure devices are slidably mated to the flexible member.