System and method for sealing an incisional wound

Information

  • Patent Grant
  • 10946125
  • Patent Number
    10,946,125
  • Date Filed
    Thursday, October 25, 2018
    6 years ago
  • Date Issued
    Tuesday, March 16, 2021
    3 years ago
Abstract
An apparatus, system, and method for treating an incisional wound having incisional walls. The apparatus includes a conduit having a first end for receiving reduced pressure and a second end. The apparatus further includes a scaffold. The scaffold has opposing surfaces for positioning adjacent the incisional walls and is fluidly coupled to the second end of the conduit for receiving the reduced pressure. The scaffold is generally elongated in shape and has a thickness between the opposing surfaces that is sufficiently thin for positioning within the incisional wound. The apparatus further includes an internal manifold that has a primary flow channel extending generally longitudinally within the scaffold and between the opposing surfaces of the scaffold. The internal manifold is fluidly coupled to the second end of the conduit. The application of the reduced pressure through the scaffold and the internal manifold induces tissue apposition between the incisional walls.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention

The present disclosure relates generally to medical treatment systems and in particular to apparatuses and systems suitable for use as scaffolds in the treatment of wounds.


2. Description of Related Art

Clinical studies and practice have shown that providing a reduced pressure in proximity to a tissue site augments and accelerates the growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but application of reduced pressure has been particularly successful in treating wounds. This treatment (frequently referred to in the medical community as “negative pressure wound therapy,” “reduced pressure therapy,” or “vacuum therapy”) provides a number of benefits, including faster healing and increased formation of granulation tissue. Typically, reduced pressure has been applied to tissue through a porous pad or other manifolding device. The porous pad contains pores that are capable of distributing reduced pressure to the tissue and channeling fluids that are drawn from the tissue. The porous pad often is incorporated into a dressing having other components that facilitate treatment. A scaffold can also be placed into a defect to support tissue growth into the defect. The scaffold is usually bioabsorbable, leaving new tissue in its place.


Synthetic and biologic scaffolds have been utilized to provide three-dimensional frameworks for augmenting endogenous cell attachment, migration, and colonization. To date, nearly all scaffolds have been designed with the idea that they can be made to work with the biology. Traditional scaffolding technologies, however, rely on the passive influx of endogenous proteins, cytokines, growth factors, and cells into the interstitium of the porous scaffold. As such, the colonization of endogenous cells into the scaffold is limited by the distance away from vascular elements, which provide nutrient support within a diffusion limit of the scaffold, regardless of tissue type. In addition, the scaffolds can also elicit an immunogenic or foreign body response that leads to an elongated repair process. Taken together, these complications can all lead to less than desired functional tissue regeneration at the injury site.


It would therefore be advantageous to provide additional systems and apparatuses for the repair or regeneration of tissues resulting from specific injuries or incisions at various tissue sites. The present invention provides such systems and apparatuses.


SUMMARY

The systems, apparatuses, and methods of the illustrative embodiments described herein include an apparatus for treating an incisional wound having incisional walls. The apparatus includes a conduit having a first end for receiving reduced pressure and a second end. The apparatus further includes a scaffold. The scaffold has opposing surfaces for positioning adjacent the incisional walls and is fluidly coupled to the second end of the conduit for receiving the reduced pressure. The scaffold is generally elongated in shape and has a thickness between the opposing surfaces that is sufficiently thin for positioning within the incisional wound. The apparatus further includes an internal manifold that has a primary flow channel extending generally longitudinally within the scaffold and between the opposing surfaces of the scaffold. The internal manifold is fluidly coupled to the second end of the conduit. The application of the reduced pressure through the scaffold and the internal manifold induces tissue apposition between the incisional walls.


According to another illustrative embodiment, a system for treating an incisional wound having incisional walls includes a pressure source to supply reduced pressure, a conduit fluidly coupled to the pressure source that has a first end for receiving the reduced pressure and a second end, and a scaffold fluidly coupled to the second end of the conduit. The scaffold has opposing surfaces, is formed from a porous material, and is generally elongated in shape. The system further includes an internal manifold that has a primary flow channel extending generally longitudinally within the scaffold between the opposing surfaces. The internal manifold is fluidly coupled to the second end of the conduit. The application of the reduced pressure through the scaffold and the internal manifold induces tissue apposition between the incisional walls.


According to another illustrative embodiment, a system for treating an incisional wound having incisional walls includes a pressure source to supply reduced pressure, a conduit fluidly coupled to the pressure source that has a first end for receiving the reduced pressure and a second end, and a scaffold fluidly coupled to the second end of the conduit. The scaffold has opposing surfaces, is formed from a porous material, and is generally elongated in shape. The system further includes an internal manifold that has a primary flow channel extending generally longitudinally within the scaffold between the opposing surfaces. The internal manifold is fluidly coupled to the second end of the conduit. The internal manifold further includes tributary flow channels fluidly coupled to the primary flow channel and extending generally transversely within the scaffold between the opposing surfaces. The tributary flow channels extend generally perpendicular from the primary flow channel. The application of the reduced pressure through the scaffold and the internal manifold induces tissue apposition between the incisional walls.


According to yet another illustrative embodiment, a method for treating an incisional wound having incisional walls includes fluidly coupling a conduit to a source of reduced pressure, wherein the conduit has a first end for receiving reduced pressure and a second end. The scaffold is fluidly coupled to the second end of the conduit for receiving the reduced pressure, wherein the scaffold is formed from sufficiently thin porous material having an internal manifold extending generally longitudinally between opposing surfaces of the scaffold. The opposing surfaces of the scaffold are positioned between the incisional walls of the incisional wound and the internal manifold is fluidly coupled to the second end of the conduit. The incisional wound is surgically closed and reduced pressure is provided through the conduit to the scaffold and the internal manifold onto the incisional wound, whereby the scaffold induces tissue apposition between the incisional walls.


Other objects, features, and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follows.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a schematic, perspective view of a reduced pressure treatment system including a scaffold according to one illustrative embodiment;



FIG. 2 is a schematic, cross-sectional, perspective view of an incisional wound and the scaffold shown in FIG. 1 positioned within the incisional wound;



FIG. 3 is a schematic, cross-sectional, perspective view of an incisional wound and the scaffold shown in FIG. 1 positioned below the opening of the incisional wound; and



FIG. 4 is a schematic, cross-sectional, perspective view of an incisional wound and the scaffold shown in FIG. 2 including a drape covering the incisional wound.





DETAILED DESCRIPTION

In the following detailed description of the illustrative embodiments, reference is made to the accompanying drawings that form a part herein. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the embodiments described herein, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the illustrative embodiments are defined only by the appended claims.


Referring to FIGS. 1 and 2, a reduced pressure treatment system 100 for applying a reduced pressure to a tissue site 102 of a patient according to an illustrative embodiment is shown. The reduced pressure treatment system 100 applies reduced pressure to an incisional wound 104 through an incisional opening 103 in epidermis 105 extending through dermis 106 into the fascial layers or subcutaneous tissues 107 at the tissue site 102. The term “incisional wound” refers to severed tissue at a tissue site such as, for example, a laceration, incision, or puncture that may have been caused by trauma, surgery, or degeneration. For example, an incisional wound may be an incision or puncture made by a surgeon in otherwise healthy tissue that extends up to 40 cm or more in length. In this sense, the incisional wound 104 is substantially a long and narrow shape, elongated shape, wherein the length represents the longitudinal axis of the incisional wound 104. Incisional wounds may extend to different depths extending up to 15 cm or more, or be subcutaneous depending on the type of tissue and the cause of the incision. The depth represents the transverse axis of the incisional wound 104. The incisional wound 104 is surrounded by tissue adjacent the incisional opening 103 at the tissue site 102 and is formed by incisional walls 108 and 109. Although the incisional wound 104 is shown as an epidermal incision at the tissue site 102, the incisional wound 104 may also be, for example, an incision in an organ adjacent a fistula. Subcutaneous, absorbable sutures (not shown) may be placed in one or more fascial layers or the subcutaneous tissues 107.


The system 100 comprises a canister 110 having a filter (not shown) contained with the canister 110 and a reduced pressure source 112 coupled in fluid communication with the canister 110 via a first conduit 111. The system 100 further comprises a scaffold 114 positioned within the incisional wound 104 between the incisional walls 108, 109. The scaffold 114 includes an upper edge portion 124 positioned adjacent the incisional opening 103 of the incisional wound 104, a lower edge portion 125, and opposing, interfacial surfaces 145 and 147 positioned adjacent the faces of the incisional walls 109 and 108, respectively, of the incisional wound 104. The scaffold 114 is coupled in fluid communication with the reduced pressure source 112 through the canister 110 via a second conduit 113 which is fluidly coupled to the scaffold 114 by a conduit connector 115. The system 100 may also comprise a fluid supply 116 coupled in fluid communication to the scaffold 114 via a third conduit 117 either directly (not shown) or indirectly through the second conduit 113 for delivering a fluid 118 to the incisional wound 104 at the tissue site 102.


The reduced pressure source 112 is an electrically-driven vacuum pump. In another implementation, the reduced pressure source 112 instead may be a manually-actuated or manually-charged pump that does not require electrical power. The reduced pressure source 112 may be any other type of reduced pressure pump, or alternatively a wall suction port such as those available in hospitals and other medical facilities. The reduced pressure source 112 may be housed within or used in conjunction with a reduced pressure treatment unit 120 which may also contain a processing unit, sensors, alarm indicators, memory, databases, software, display units, and user interfaces that further facilitate the application of reduced pressure treatment to the tissue site 102. In one example, a sensor or switch (not shown) may be disposed at or near the reduced pressure source 112 to determine a source pressure generated by the reduced pressure source 112. The sensor may communicate with a processing unit (not shown) that monitors and controls the reduced pressure that is delivered by the reduced pressure source 112. The canister 110 may be a fluid reservoir, or collection member, to filter or hold exudates and other fluids removed from the tissue site 102. In one embodiment, the canister 110 and the reduced pressure source 112 are integrated into a single housing structure.


The fluid supply 116 may be used to deliver growth and/or healing agents to the scaffold 114 for the incisional wound 104 including, without limitation, an antibacterial agent, an antiviral agent, a cell-growth promotion agent, an irrigation fluid, or other chemically active agents. The system 100 further comprises a first valve 127 positioned in the third conduit 117 to control the flow of fluid 118 to the scaffold 114, and a second valve 123 positioned in the second conduit 113 between the reduced pressure source 112 and the juncture between the second conduit 113 and the third conduit 117 to control the flow of reduced pressure. The processing unit of the reduced pressure treatment unit 120 is operatively connected to the first and second valves 127, 123 to control the delivery of reduced pressure and/or fluid from the fluid supply 116, respectively, to the scaffold 114 as required by the particular therapy being administered to the patient. The fluid supply 116 may deliver the fluids as indicated above, but may also deliver air to the scaffold 114 to promote healing and facilitate drainage of the incisional wound 104. The fluid 118 may be gas or liquid, and may contain growth factors, healing factors, or other substances to treat the incisional wound 104 at the tissue site 102. For example, the fluid 118 may be water, saline, or dye saline.


The term “scaffold” as used herein refers to a substance or structure applied to or positioned in a wound or defect that provides a structural matrix for the growth of cells and/or the formation of tissue. A scaffold is a three-dimensional, porous structure having dimensions roughly corresponding to the shape of the specific wound defect. The scaffold 114 may be infused with, coated with, or comprised of cells, growth factors, extracellular matrix components, nutrients, proteins, or other substances to promote cell growth. The scaffold 114 may possess characteristics of a manifold by directing the flow of fluids through its structural matrix. For example, the scaffold 114 may take on the characteristics of a manifold by directing reduced pressure or delivering fluids to a tissue site, or removing fluids from a tissue site. As used herein, the term “manifold” refers to a substance or structure that is provided to assist in directing reduced pressure or delivering fluids to a tissue site, or removing fluids from a tissue site. A manifold can include a plurality of flow channels or pathways that are interconnected to improve distribution of fluids provided to and removed from the area of tissue around the manifold. Examples of manifolds may include, without limitation, devices that have structural elements arranged to form flow channels, cellular foams such as open-cell foam, porous tissue collections, and liquids, gels and foams that include or cure to include flow channels. The scaffold 114 possesses the characteristics of a manifold as described above.


The scaffold 114 may be a biologic or synthetic scaffold used to support protein adhesion and cellular in-growth for tissue repair and regeneration. The current state of the art in scaffold technology relies upon the inherent characteristics of the surrounding tissue space for the adsorption of proteins and migration of cells. The scaffold 114 for use according to the invention, and coupled with its function as a manifold, provides physical guidance to direct the pathway of fluid flow within the incisional wound 104, creating avenues for the movement and migration of adhesive proteins and cells, respectively, which are integral to the establishment of a provisional matrix in predetermined patterns of organization within the tissue space. The methods and apparatuses described for fluid flow-induced generation of tissues have direct implications into the design of the scaffold 114. In certain aspects, the scaffold 114 may be a reticulated structure, such as, for example, a reticulated foam, comprising a high void fraction for improved bioabsorption properties.


Non-limiting examples of suitable scaffold materials include extracellular matrix proteins such as fibrin, collagen or fibronectin, and synthetic or naturally occurring polymers, including bioabsorbable or non-bioabsorbable polymers, such as polylactic acid (PLA), polyglycolic acid (PGA), polylactide-co-glycolide (PLGA), polyvinylpyrrolidone, polycaprolactone, polycarbonates, polyfumarates, caprolactones, polyamides, polysaccharides (including alginates (e.g., calcium alginate) and chitosan), hyaluronic acid, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyethylene glycols, poloxamers, polyphosphazenes, polyanhydrides, polyamino acids, polyortho esters, polyacetals, polycyanoacrylates, polyurethanes, polyacrylates, ethylene-vinyl acetate polymers and other acyl substituted cellulose acetates and derivatives thereof, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulphonated polyolefins, polyethylene oxide, polyvinyl alcohol, Teflon®, and nylon. The scaffold 114 can also comprise ceramics such as hydroxyapatite, coralline apatite, calcium phosphate, calcium sulfate, calcium carbonate or other carbonates, bioglass, allografts, autografts, xenografts, decellularized tissues, or composites of any of the above. In particular embodiments, the scaffold 114 comprises collagen, polylactic acid (PLA), polyglycolic acid (PGA), polylactide-co-glycolide (PLGA), a polyurethane, a polysaccharide, an hydroxyapatite, or a polytherylene glycol. Additionally, the scaffold 114 may comprise combinations of any two, three or more materials, either in separate areas of the scaffold 114, or combined noncovalently, or covalently (e.g., copolymers such as a polyethylene oxide-polypropylene glycol block copolymers, or terpolymers), or combinations thereof.


In one embodiment, the scaffold 114 is formed from a scaffold material comprising PLGA fibers formed by a felting process that also functions as a manifold as described above. Such material known as Scaftex™ is available from Biomedical Structures, Inc. Any of the biodegradable or bioresorbable materials listed above that are reticulated and possess a high void fraction (low mass for degradation or resorption) may be used. The elastomeric materials, pliable materials, and gels are embodiments that are preferred for soft-tissue applications such as the incisional wound 104. The scaffold 114 is relatively thin between the opposing, interfacial surfaces 145, 147 which are positioned adjacent the incisional walls 109, 108, respectively, of the incisional wound 104. In one non-limiting example, the scaffold 114 may be approximately 0.25 mm to 3.0 mm thick between the opposing, interfacial surfaces 145, 147. Comparing the thickness of the scaffold 114 to the length and depth of the incisional wound 104, the scaffold 114 may be described as being relatively thin. In one embodiment, a ratio of the length to the thickness of the scaffold 114 is greater than about 10. Preferably, the scaffold 114 should be as thin as possible to fit within the incisional wound 104, minimizing the distance between the incisional walls 108, 109 to facilitate tissue apposition. Although the scaffold 114 is sufficiently thin, the material forming the scaffold 114 still comprises a matrix of pathways (not shown) to facilitate the flow of fluid between the incisional walls 108, 109. These pathways of the scaffold 114 extend through the scaffold 114 between the opposing, interfacial surfaces 145, 147 to induce tissue apposition by promoting the growth of tissue between the incisional walls 108, 109 as an interfacial scaffold matrix within the incisional wound 104.


The scaffold 114 may be of any size or shape depending on a variety of factors such as, for example, the type and size of the incisional wound 104 and the type of treatment being implemented to repair the wound. For example, the scaffold 114 may be substantially rectangular extending the full length of the incisional wound 104 along the longitudinal axis and the full depth of the incisional walls 108, 109 along the transverse axis. The scaffold 114 of such dimensions forms a full interfacial scaffold matrix between the two incisional walls 108, 109 to induce tissue apposition between the two. However, depending on the treatment, the scaffold 114 may only partially contact the incisional walls 108, 109. For example, the scaffold 114 may not extend to the bottom of the incisional wound 104 into the subcutaneous tissues 107. The upper edge portion 124 of the scaffold 114 may be positioned flush with the incisional opening 103 of the incisional wound 104 adjacent the epidermis 105, and secured within the incisional wound 104 by a plurality of sutures 130 that close the incisional wound 104 when stitched.


The scaffold 114 may further comprise an internal manifold structure 140 to supplement the flow of fluid through the reticulated pathways that already exist within the scaffold 114. The internal manifold structure 140 may comprise one or a plurality of primary flow channels 141 fluidly coupled to the conduit connector 115 that extend generally longitudinally through the scaffold 114 between the incisional walls 108, 109. The internal manifold structure 140 may also comprise additional tributary channels 143 fluidly coupled to one or more of the primary flow channels 141. The tributary channels 143 extend generally transversely within the scaffold 114 between the opposing, interfacial surfaces 145, 147 to further facilitate fluid flow over a larger area of the interfacial scaffold matrix within the incisional wound 104. The tributary channels 143 may extend from the primary flow channel 141 in any direction relative to the primary flow channel 141 and may form any shape to enhance the area of the scaffold 114 covering the interfacial surfaces 145, 147. For example, as shown in a specific, non-limiting embodiment, the tributary channels 143 extend in a direction generally perpendicular from the primary flow channel 141 in a linear direction as opposed to having a curved shape. Thus, the internal manifold structure 140 provides a supplemental matrix for fluid flow coextensive with the reticulated pathways of the scaffold 114 by using the plurality of primary flow channels 141 or a single primary channel that may include the plurality of tributary channels 143 or a combination of both. This supplemental matrix of the internal manifold structure 140 may be formed with a pattern that further induces apposition of the incisional walls 108, 109.


Although the primary flow channel 141 is shown as a generally tubular shape in the figures, the primary flow channel 141 may be a variety of different shapes as long as such flow channel extends generally longitudinally through the scaffold 114 between the incisional walls 108, 109. The primary flow channel 141 does not need to be straight, but may undulate longitudinally within the scaffold 114 between the upper edge portion 124 and lower edge portion 125. The primary flow channel 141 may also be an anisotropic material property of the scaffold 114 itself extending generally longitudinally between the incisional walls 108, 109. For example, the anisotropic property may be a differential resistance to fluid flow through interconnected pores within the scaffold 114 extending along a generally longitudinal axis of the scaffold 114. The anisotropic property may also be the alignment of pores and their interconnectivity within the scaffold 114, or the variation of pore size within the scaffold 114 that permits or facilitates fluid flow along a longitudinal axis of the scaffold 114. In another embodiment, the primary flow channel 141 may be formed by a bioresorbable tubing.


The tributary channels 143 may be asymmetric in shape and formed from anisotropic properties of the scaffold 114. In another embodiment, the tributary channels 143 may be formed by a bioresorbable tubing. Although inlets of the tributary channels 143 are shown extending from the surface of the primary flow channel 141, the tributary channels 143 may also extend from loci within the primary flow channel 141 and diverge within the scaffold 114 as non-parallel, asymmetric passages. The inlets of such tributary channels 143 are in fluid communication with the primary flow channel 141 to facilitate the flow of fluids between the incisional walls 108, 109. The inlets of several tributary channels 143 may also originate and diverge from a single locus within the primary flow channel 141 in a star-pattern, for example, generally in parallel with and between the incisional walls 108, 109.


Referring to FIG. 3, the scaffold 114 may be positioned within the incisional wound 104 so that the upper edge portion 124 of the scaffold 114 is seated below the epidermis 105 such that sutures 230 may be used to close the entire scaffold 114 within the incisional wound 104. Seating the upper edge portion 124 of the scaffold 114 below the epidermis 105 of the incisional wound 104 may facilitate closure of the incisional opening 103 of the incisional wound 104 and help maintain the reduced-pressure within the incisional wound 104 for a longer period of time. Referring back to FIG. 2, in an alternative embodiment (not shown) the upper edge portion 124 of the scaffold 114 may protrude out of the incisional opening 103 above the epidermis 105 so that the sutures 130 may be stitched through the upper portion of the scaffold 114 to hold it firmly in place within the incisional wound 104. In this embodiment, the sutures 130 may be stitched sufficiently tight to substantially close the incisional opening 103 of the wound to further facilitate healing as described above.


In another embodiment shown in FIG. 4, the scaffold 114 may be exposed through the incisional opening 103 in the epidermis 105 as opposed to being closed within the incisional wound 104. In this embodiment, the system 100 may further comprise an external manifold 150 in fluid communication with the scaffold 114 and a drape 152 covering the external manifold 150 to maintain reduced pressure beneath the drape 152 within the incisional wound 104. The drape 152 includes an aperture 153 through which the conduit connector 115 extends to provide fluid communication between the second conduit 113 and the external manifold 150. The drape 152 may also include a periphery portion 154 that extends beyond the incisional opening 103 and includes an adhesive or bonding agent (not shown) to secure the drape 152 to the healthy tissue adjacent the incisional opening 103. The adhesive provides a seal between the drape 152 and the epidermis 105 to better maintain reduced pressure within the incisional wound 104. In another embodiment, a seal layer (not shown) such as, for example, a hydrogel or other material, may be disposed between the drape 152 and the epidermis 105 to augment or substitute for the sealing properties of the adhesive. The drape 152 may also be used in conjunction with the embodiments shown in FIGS. 2 and 3 described above.


The drape 152 may be any material that provides a pneumatic or fluid seal. The drape 152 may, for example, be an impermeable or semi-permeable, elastomeric material. As stated above, the drape 152 may include an adhesive layer on the periphery portion 154.


In view of the above, it will be seen that the advantages of the invention are achieved and other advantages attained. As various changes could be made in the above methods and compositions without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.


It will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments. It will further be understood that reference to “an” item refers to one or more of those items.


Where appropriate, aspects of any of the examples and embodiments described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems.


It will be understood that the above description of preferred embodiments is given by way of example only and that various modifications may be made by those skilled in the art. The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments of the invention. Although various embodiments of the invention have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention.

Claims
  • 1. An apparatus to treat an incisional wound having incisional walls, the apparatus comprising: a scaffold comprising a bioresorbable material configured to be positioned within the incisional wound and to support protein adhesion and cellular in-growth;an internal manifold having a primary flow channel configured to extend within the scaffold to fluidly couple to a reduced pressure source;an external manifold in fluid communication with a portion of the scaffold; anda drape formed of substantially impermeable material to cover the external manifold and the scaffold within the incisional wound.
  • 2. The apparatus of claim 1, wherein the internal manifold further comprises one or more tributary flow channels fluidly coupled to the primary flow channel and extending generally transversely within the scaffold.
  • 3. The apparatus of claim 2, wherein the one or more tributary flow channels extend generally perpendicular from the primary flow channel.
  • 4. The apparatus of claim 2, wherein at least one of the one or more tributary flow channels originate from a single location of the primary flow channel.
  • 5. The apparatus of claim 1, wherein the primary flow channel is an anisotropic property of the scaffold.
  • 6. The apparatus of claim 1, wherein the primary flow channel is formed by bioresorbable tubing.
  • 7. The apparatus of claim 1, wherein the primary flow channel is formed by an alignment of one or more interconnected pores of the scaffold.
  • 8. The apparatus of claim 1, wherein the thickness of the scaffold is less than about 3.0 mm.
  • 9. The apparatus of claim 1, wherein the thickness of the scaffold is greater than about 0.25 mm.
  • 10. The apparatus of claim 1, wherein a ratio of a length to the thickness of the scaffold is greater than about 10.
  • 11. The apparatus of claim 10, wherein the external manifold is configured to be positioned outside the incisional wound.
  • 12. The apparatus of claim 1, wherein the scaffold is formed from polylactide-co-glycolide.
  • 13. The apparatus of claim 12, wherein the scaffold is formed from resorbable polyurethane.
  • 14. The apparatus of claim 13, wherein the scaffold is formed from decellularized biological material.
  • 15. The apparatus of claim 1, wherein the scaffold is formed from collagen.
  • 16. The apparatus of claim 1, wherein the scaffold is a reticulated structure.
  • 17. The apparatus of claim 1, further comprising a conduit for fluidly coupling to the primary flow channel.
  • 18. The apparatus of claim 17, further comprising a reduced pressure source fluidly coupled to the conduit.
  • 19. An apparatus to treat an incisional wound having incisional walls, the apparatus comprising: a scaffold configured to be positioned adjacent the incisional walls; andan internal manifold having a primary flow channel configured to extend within the scaffold to fluidly couple to a reduced pressure source, wherein the primary flow channel is formed by bioresorbable tubing.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 15/174,451, filed Jun. 6, 2016, which is a Continuation of U.S. application Ser. No. 14/088,027, filed Nov. 22, 2013, now U.S. Pat. No. 9,381,284, which is a divisional of U.S. patent application Ser. No. 13/095,384, filed on Apr. 27, 2011, now U.S. Pat. No. 8,623,047, which claims the benefit of U.S. Provisional Application No. 61/329,764, filed Apr. 30, 2010. Each of the above applications are incorporated herein by reference.

US Referenced Citations (132)
Number Name Date Kind
1355846 Rannells Oct 1920 A
2547758 Keeling Apr 1951 A
2632443 Lesher Mar 1953 A
2682873 Evans et al. Jul 1954 A
2910763 Lauterbach Nov 1959 A
2969057 Simmons Jan 1961 A
3066672 Crosby, Jr. et al. Dec 1962 A
3367332 Groves Feb 1968 A
3520300 Flower, Jr. Jul 1970 A
3568675 Harvey Mar 1971 A
3648692 Wheeler Mar 1972 A
3682180 McFarlane Aug 1972 A
3826254 Mellor Jul 1974 A
4080970 Miller Mar 1978 A
4096853 Weigand Jun 1978 A
4139004 Gonzalez, Jr. Feb 1979 A
4165748 Johnson Aug 1979 A
4184510 Murry et al. Jan 1980 A
4233969 Lock et al. Nov 1980 A
4245630 Lloyd et al. Jan 1981 A
4256109 Nichols Mar 1981 A
4261363 Russo Apr 1981 A
4275721 Olson Jun 1981 A
4284079 Adair Aug 1981 A
4297995 Golub Nov 1981 A
4333468 Geist Jun 1982 A
4373519 Errede et al. Feb 1983 A
4382441 Svedman May 1983 A
4392853 Muto Jul 1983 A
4392858 George et al. Jul 1983 A
4419097 Rowland Dec 1983 A
4465485 Kashmer et al. Aug 1984 A
4475909 Eisenberg Oct 1984 A
4480638 Schmid Nov 1984 A
4525166 Leclerc Jun 1985 A
4525374 Vaillancourt Jun 1985 A
4540412 Van Overloop Sep 1985 A
4543100 Brodsky Sep 1985 A
4548202 Duncan Oct 1985 A
4551139 Plaas et al. Nov 1985 A
4569348 Hasslinger Feb 1986 A
4605399 Weston et al. Aug 1986 A
4608041 Nielsen Aug 1986 A
4640688 Hauser Feb 1987 A
4655754 Richmond et al. Apr 1987 A
4664662 Webster May 1987 A
4710165 McNeil et al. Dec 1987 A
4733659 Edenbaum et al. Mar 1988 A
4743232 Kruger May 1988 A
4758220 Sundblom et al. Jul 1988 A
4787888 Fox Nov 1988 A
4826494 Richmond et al. May 1989 A
4838883 Matsuura Jun 1989 A
4840187 Brazier Jun 1989 A
4863449 Therriault et al. Sep 1989 A
4872450 Austad Oct 1989 A
4878901 Sachse Nov 1989 A
4897081 Poirier et al. Jan 1990 A
4906233 Moriuchi et al. Mar 1990 A
4906240 Reed et al. Mar 1990 A
4919654 Kalt Apr 1990 A
4941882 Ward et al. Jul 1990 A
4953565 Tachibana et al. Sep 1990 A
4969880 Zamierowski Nov 1990 A
4985019 Michelson Jan 1991 A
5037397 Kalt et al. Aug 1991 A
5086170 Luheshi et al. Feb 1992 A
5092858 Benson et al. Mar 1992 A
5100396 Zamierowski Mar 1992 A
5134994 Say Aug 1992 A
5149331 Ferdman et al. Sep 1992 A
5167613 Karami et al. Dec 1992 A
5176663 Svedman et al. Jan 1993 A
5215522 Page et al. Jun 1993 A
5232453 Plass et al. Aug 1993 A
5261893 Zamierowski Nov 1993 A
5278100 Doan et al. Jan 1994 A
5279550 Habib et al. Jan 1994 A
5298015 Komatsuzaki et al. Mar 1994 A
5342376 Ruff Aug 1994 A
5344415 DeBusk et al. Sep 1994 A
5358494 Svedman Oct 1994 A
5437622 Carion Aug 1995 A
5437651 Todd et al. Aug 1995 A
5527293 Zamierowski Jun 1996 A
5549584 Gross Aug 1996 A
5556375 Ewall Sep 1996 A
5607388 Ewall Mar 1997 A
5636643 Argenta et al. Jun 1997 A
5645081 Argenta et al. Jul 1997 A
6071267 Zamierowski Jun 2000 A
6135116 Vogel et al. Oct 2000 A
6241747 Ruff Jun 2001 B1
6287316 Agarwal et al. Sep 2001 B1
6345623 Heaton et al. Feb 2002 B1
6488643 Tumey et al. Dec 2002 B1
6493568 Bell et al. Dec 2002 B1
6553998 Heaton et al. Apr 2003 B2
6814079 Heaton et al. Nov 2004 B2
7381859 Hunt Jun 2008 B2
7846141 Weston Dec 2010 B2
8062273 Weston Nov 2011 B2
8197467 Heaton Jun 2012 B2
8216198 Heagle et al. Jul 2012 B2
8251979 Malhi Aug 2012 B2
8257327 Blott et al. Sep 2012 B2
8398614 Blott et al. Mar 2013 B2
8430867 Robinson Apr 2013 B2
8449509 Weston May 2013 B2
8486032 Seegert Jul 2013 B2
8529548 Blott et al. Sep 2013 B2
8535296 Blott et al. Sep 2013 B2
8551060 Schuessler et al. Oct 2013 B2
8568386 Malhi Oct 2013 B2
8608776 Coward Dec 2013 B2
8623047 Cornet Jan 2014 B2
8679081 Heagle et al. Mar 2014 B2
8834451 Blott et al. Sep 2014 B2
8926592 Blott et al. Jan 2015 B2
9017302 Vitaris et al. Apr 2015 B2
9198801 Weston Dec 2015 B2
9211365 Weston Dec 2015 B2
9289542 Blott et al. Mar 2016 B2
10016307 Heaton Jul 2018 B2
10137228 Cornet Nov 2018 B2
10682251 Hall Jun 2020 B2
20020077661 Saadat Jun 2002 A1
20020115951 Norstrem et al. Aug 2002 A1
20020120185 Johnson Aug 2002 A1
20020143286 Tumey Oct 2002 A1
20140163491 Schuessler et al. Jun 2014 A1
20150080788 Blott et al. Mar 2015 A1
Foreign Referenced Citations (29)
Number Date Country
550575 Mar 1986 AU
745271 Mar 2002 AU
755496 Dec 2002 AU
2005436 Jun 1990 CA
26 40 413 Mar 1978 DE
43 06 478 Sep 1994 DE
29 504 378 Sep 1995 DE
0100148 Feb 1984 EP
0117632 Sep 1984 EP
0161865 Nov 1985 EP
0358302 Mar 1990 EP
1018967 Jul 2000 EP
692578 Jun 1953 GB
2 195 255 Apr 1988 GB
2 197 789 Jun 1988 GB
2 220 357 Jan 1990 GB
2 235 877 Mar 1991 GB
2 329 127 Mar 1999 GB
2 333 965 Aug 1999 GB
4129536 Aug 2008 JP
71559 Apr 2002 SG
8002182 Oct 1980 WO
8704626 Aug 1987 WO
90010424 Sep 1990 WO
93009727 May 1993 WO
94020041 Sep 1994 WO
9605873 Feb 1996 WO
9718007 May 1997 WO
9913793 Mar 1999 WO
Non-Patent Literature Citations (40)
Entry
Louis C. Argenta, MD and Michael J. Morykwas, PHD; Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Clinical Experience; Annals of Plastic Surgery; vol. 38, No. 6, Jun. 1997; pp. 563-576.
Susan Mendez-Eatmen, RN; “When wounds Won't Heal” RN Jan. 1998, vol. 61 (1); Medical Economics Company, Inc., Montvale, NJ, USA; pp. 20-24.
James H. Blackburn II, MD et al.: Negative-Pressure Dressings as a Bolster for Skin Grafts; Annals of Plastic Surgery, vol. 40, No. 5, May 1998, pp. 453-457; Lippincott Williams & Wilkins, Inc., Philidelphia, PA, USA.
John Masters; “Reliable, Inexpensive and Simple Suction Dressings”; Letter to the Editor, British Journal of Plastic Surgery, 1998, vol. 51 (3), p. 267; Elsevier Science/The British Association of Plastic Surgeons, UK.
S.E. Greer, et al. “The Use of Subatmospheric Pressure Dressing Therapy to Close Lymphocutaneous Fistulas of be Groin” British Journal of Plastic Surgery (2000), 53, pp. 484-487.
George V. Letsou, MD., et al; “Stimulation of Adenylate Cyclase Activity in Cultured Endothelial Cells Subjected to Cyclic Stretch”; Journal of Cardiovascular Surgery, 31, 1990, pp. 634-639.
Orringer, Jay, et al; “Management of Wounds in Patients with Complex Enterocutaneous Fistulas”; Surgery, Gynecology & Obstetrics, Jul. 1987, vol. 165, pp. 79-80.
International Search Report for PCT International Application PCT/GB95/01983; dated Nov. 23, 1995.
PCT International Search Report for PCT International Application PCT/GB98/02713; dated Jan. 8, 1999.
PCT Written Opinion; PCT International Application PCT/GB98/02713; dated Jun. 8, 1999.
PCT International Examination and Search Report, PCT International Application PCT/GB96/02802; dated Jan. 15, 1998 & Apr. 29, 1997.
PCT Written Opinion, PCT International Application PCT/GB96/02802; dated Sep. 3, 1997.
Dattilo, Philip P., Jr., et al; “Medical Textiles: Application of an Absorbable Barbed Bi-directional Surgical Suture”; Journal of Textile and Apparel, Technology and Management, vol. 2, Issue 2, Spring 2002, pp. 1-5.
Kostyuchenok, B.M., et al; “Vacuum Treatment in the Surgical Management of Purulent Wounds”; Vestnik Khirurgi, Sep. 1986, pp. 18-21 and 6 page English translation thereof.
Davydov, Yu. A., et al; “Vacuum Therapy in the Treatment of Purulent Lactation Mastitis”; Vestnik Khirurgi, May 14, 1986, pp. 66-70, and 9 page English translation thereof.
Yusupov. Yu.N., et al; “Active Wound Drainage”, Vestnki Khirurgi, vol. 138, Issue 4, 1987, and 7 page English translation thereof.
Davydov, Yu.A., et al; “Bacteriological and Cytological Assessment of Vacuum Therapy for Purulent Wounds”; Vestnik Khirugi, Oct. 1988, pp. 48-52, and 8 page English translation thereof.
Davydov, Yu.A., et al; “Concepts for the Clinical-Biological Management of the Wound Process in the Treatment of Purulent Wounds by Means of Vacuum Therapy”; Vestnik Khirurgi, Jul. 7, 1980, pp. 132-136, and 8 page English translation thereof.
Chariker, Mark E., M.D., et al; “Effective Management of incisional and cutaneous fistulae with closed suction wound drainage”; Contemporary Surgery, vol. 34, Jun. 1989, pp. 59-63.
Egnell Minor, Instruction Book, First Edition, 300 7502, Feb. 1975, pp. 24.
Egnell Minor: Addition to the Users Manual Concerning Overflow Protection—Concerns all Egnell Pumps, Feb. 3, 1983, pp. 2.
Svedman, P.: “Irrigation Treatment of Leg Ulcers”, The Lancet, Sep. 3, 1983, pp. 532-534.
Chinn, Steven D. et al.: “Closed Wound Suction Drainage”, The Journal of Foot Surgery, vol. 24, No. 1, 1985, pp. 76-81.
Arnljots, Björn et al: “Irrigation Treatment in Split-Thickness Skin Grafting of Intractable Leg Ulcers”, Scand J. Plast Reconstr. Surg., No. 19, 1985, pp. 211-213.
Svedman, P.: “A Dressing Allowing Continuous Treatment of a Biosurface”, IRCS Medical Science: Biomedical Technology, Clinical Medicine, Surgery and Transplantation, vol. 7, 1979, p. 221.
Svedman, P. et al: “A Dressing System Providing Fluid Supply and Suction Drainage Used for Continuous of Intermittent Irrigation”, Annals of Plastic Surgery, vol. 17, No. 2, Aug. 1986, pp. 125-133.
N.A. Bagautdinov, “Variant of External Vacuum Aspiration in the Treatment of Purulent Diseases of Soft Tissues,” Current Problems in Modern Clinical Surgery: Interdepartmental Collection, edited by V. Ye Volkov et al. (Chuvashia State University, Cheboksary, U.S.S.R. 1986); pp. 94-96 (copy and certified translation).
K.F. Jeter, T.E. Tintle, and M. Chariker, “Managing Draining Wounds and Fistulae: New and Established Methods,” Chronic Wound Care, edited by D. Krasner (Health Management Publications, Inc., King of Prussia, PA 1990), pp. 240-246.
G. {hacek over (Z)}ivadinovi?, V. ?uki?, {hacek over (Z)}. Maksimovi?, ?. Radak, and P. Pe{hacek over (s)}ka, “Vacuum Therapy in the Treatment of Peripheral Blood Vessels,” Timok Medical Journal 11 (1986), pp. 161-164 (copy and certified translation).
F.E. Johnson, “An Improved Technique for Skin Graft Placement Using a Suction Drain,” Surgery, Gynecology, and Obstetrics 159 (1984), pp. 584-585.
A.A. Safronov, Dissertation Abstract, Vacuum Therapy of Trophic Ulcers of the Lower Leg with Simultaneous Autoplasty of the Skin (Central Scientific Research Institute of Traumatology and Orthopedics, Moscow, U.S.S.R. 1967) (copy and certified translation).
M. Schein, R. Saadia, J.R. Jamieson, and G.A.G. Decker, “The ‘Sandwich Technique’ in the Management of the Open Abdomen,” British Journal of Surgery 73 (1986), pp. 369-370.
D.E. Tribble, An Improved Sump Drain-Irrigation Device of Simple Construction, Archives of Surgery 105 (1972) pp. 511-513.
M.J. Morykwas, L.C. Argenta, E.I. Shelton-Brown, and W. McGuirt, “Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Animal Studies and Basic Foundation,” Annals of Plastic Surgery 38 (1997), pp. 553-562 (Morykwas I).
C.E. Tennants, “The Use of Hypermia in the Postoperative Treatment of Lesions of the Extremities and Thorax,” Journal of the American Medical Association 64 (1915), pp. 1548-1549.
Selections from W. Meyer and V. Schmieden, Bier's Hyperemic Treatment in Surgery, Medicine, and the Specialties: A Manual of Its Practical Application, (W.B. Saunders Co., Philadelphia, PA 1909), pp. 17-25, 44-64, 90-96, 167-170, and 210-211.
V.A. Solovev et al., Guidelines, The Method of Treatment of Immature External Fistulas in the Upper Gastrointestinal Tract, editor-in-chief Prov. V.I. Parahonyak (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1987) (“Solovev Guidelines”).
V.A. Kuznetsov & N.a. Bagautdinov, “Vacuum and Vacuum-Sorption Treatment of Open Septic Wounds,” in II All-Union Conference on Wounds and Wound Infections: Presentation Abstracts, edited by B.M. Kostyuchenok et al. (Moscow, U.S.S.R. Oct. 28-29, 1986) pp. 91-92 (“Bagautdinov II”).
V.A. Solovev, Dissertation Abstract, Treatment and Prevention of Suture Failures after Gastric Resection (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1988) (“Solovev Abstract”).
V.A.C. ® Therapy Clinical Guidelines: A Reference Source for Clinicians; Jul. 2007.
Related Publications (1)
Number Date Country
20190060537 A1 Feb 2019 US
Provisional Applications (1)
Number Date Country
61329764 Apr 2010 US
Divisions (1)
Number Date Country
Parent 13095384 Apr 2011 US
Child 14088027 US
Continuations (2)
Number Date Country
Parent 15174451 Jun 2016 US
Child 16171069 US
Parent 14088027 Nov 2013 US
Child 15174451 US