NEGATIVE PRESSURE WOUND CLOSURE DEVICE
20200078221 ยท 2020-03-12
Inventors
Cpc classification
A61M1/915
HUMAN NECESSITIES
A61F13/01021
HUMAN NECESSITIES
A61M2205/3344
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
International classification
Abstract
A negative pressure wound closure system and methods for using such a system are described. Some embodiments may utilize a stabilizing structure with a plurality of cells arranged side-by-side in a staggered fashion, wherein at least one of the cells has a hexagon shape, for example a concave-hexagon shape or a convex-hexagon shape.
Claims
1. An apparatus for treating a wound with negative pressure wound therapy, comprising: a stabilizing structure for insertion into a wound comprising: a length corresponding to a y-direction and extending along a central longitudinal axis of the stabilizing structure between a first end and a second end of the stabilizing structure; a width corresponding to an x-direction, the width being transverse to the length and extending along a central transverse axis of the stabilizing structure between a first side and a second side of the stabilizing structure; and a height corresponding to a z-direction, the height being transverse to the length and the width and extending between a top surface and a bottom surface of the stabilizing structure; wherein the length and width are each greater than the height; wherein the stabilizing structure comprises a plurality of cells defined by one or more walls, the cells being provided side-by-side in a horizontal plane parallel to the x-direction and the y-direction, wherein each of the cells has a top end and a bottom end with an opening extending through the top and bottom ends in the z-direction; wherein at least one of the cells has a concave-hexagon shape comprising two parallel sides and two internal angles greater than 180 degrees; wherein the plurality of cells are provided in a plurality of rows extending widthwise across the stabilizing structure, wherein cells of adjacent rows are staggered relative to each other; and wherein the stabilizing structure is configured such that upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound, the stabilizing structure collapses more in the horizontal plane than in the z-direction, and the stabilizing structure collapses more in the x-direction than in the y-direction.
2. (canceled)
3. The apparatus of claim 1, wherein all of the cells have a hexagon shape.
4. The apparatus of claim 1, wherein at least one of the cells is defined by two straight walls aligned in parallel fashion along the y-direction and four side walls along the x-direction, wherein side walls connect the two straight walls and wherein at least two side walls form an inner angle greater than 180 degrees.
5. (canceled)
6. The apparatus of claim 1, wherein all of the cells have the concave-hexagon shape.
7. (canceled)
8. The apparatus of claim 1, wherein at least one cell having the concave-hexagon shape is surrounded by and shares a wall with six cells also having the concave-hexagon shape.
9. The apparatus of claim 4, wherein the sum of lengths of said two straight walls is equal to or greater than the sum of lengths of said four side walls.
10. (canceled)
11. (canceled)
12. The apparatus of claim 1, wherein the stabilizing structure comprises at least one node where three or fewer walls meet.
13. The apparatus of claim 1, wherein at all nodes three or fewer walls meet.
14. The apparatus of claim 1, wherein all of the cells of the stabilizing structure have the same shape.
15. The apparatus of claim 1, wherein all of the cells of the stabilizing structure have the same size.
16. The apparatus of claim 1, wherein cells are configured such that upon collapse, each cell shows zero or substantially no change in dimension in the y direction.
17. (canceled)
18. The apparatus of claim 1, wherein the stabilizing structure is configured to allow portions of the structure to separate from a remainder of the structure.
19. The apparatus of claim 18, wherein the stabilizing structure comprises perforations or detachable sections that allow portions of the structure to separate from the remainder of the structure.
20. The apparatus of claim 1, wherein the stabilizing structure further comprises a wound wall liner.
21. (canceled)
22. (canceled)
23. An apparatus for treating a wound with negative pressure wound therapy, comprising: a stabilizing structure for insertion into a wound comprising: a length corresponding to a y-direction and extending along a central longitudinal axis of the stabilizing structure between a first end and a second end of the stabilizing structure; a width corresponding to an x-direction, the width being transverse to the length and extending along a central transverse axis of the stabilizing structure between a first side and a second side of the stabilizing structure; and a height corresponding to a z-direction, the height being transverse to the length and the width and extending between a top surface and a bottom surface of the stabilizing structure; wherein the length and width are each greater than the height; wherein the stabilizing structure comprises a plurality of cells defined by one or more walls, the cells being provided side-by-side in a horizontal plane parallel to the x-direction and the y-direction, wherein each of the cells has a top end and a bottom end with an opening extending through the top and bottom ends in the z-direction; wherein the plurality of cells are provided in a plurality of rows extending widthwise across the stabilizing structure, wherein cells of adjacent rows are staggered relative to each other; and wherein the stabilizing structure is configured such that upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound, the stabilizing structure collapses more in the horizontal plane than in the z-direction, and the stabilizing structure collapses both in the x-direction and in the y-direction, collapsing more in the x-direction than in the y-direction.
24. The apparatus of claim 23, wherein the plurality of cells are configured such that upon collapse, each cell shows zero or substantially no change in dimension in the y-direction.
25. The apparatus of claim 23, wherein at least one of the cells has a concave-hexagon shape comprising two parallel sides and two internal angles greater than 180 degrees.
26. The apparatus of claim 25, wherein at least one of the cells is defined by two straight walls aligned in parallel fashion along the y-direction and four side walls along the x-direction, wherein side walls connect the two straight walls and wherein at least two side walls form an inner angle greater than 180 degrees.
27. The apparatus of claim 26, wherein the sum of lengths of the two straight walls is equal to or greater than the sum of lengths of the side walls.
28. The apparatus of claim 23, wherein the plurality of cells are configured such that upon collapse, each cell shows zero or substantially no change in dimension in the y direction.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0014]
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[0021]
[0022]
[0023]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] Embodiments disclosed in this section or elsewhere in this specification relate to apparatuses and methods of treating a wound with reduced pressure, including pump and wound dressing components and apparatuses. Certain embodiments of stabilizing structures and related apparatuses and methods of treating a wound with reduced pressure, including pump and wound dressing components and apparatuses, have been described in PCT App. No. PCT/US2013/050698, filed Jul. 16, 2013 titled Negative Pressure Wound Closure Device, published as WO 2014/014922 A1 which is to be considered a part of this specification. Specifically, WO 2014/014922 A1 describes a stabilizing structure for insertion into a wound, which is configured to aid in the closure of large wounds, in conjunction with the administration of negative pressure.
[0025] Further, examples of such applications where additional disclosure relating to the preceding descriptions may be found include U.S. Pat. No. 8,235,955, titled Wound treatment apparatus and method, issued Aug. 7, 2012 and U.S. Pat. No. 7,753,894, titled Wound cleansing apparatus with stress, issued Jul. 13, 2010. Both applications are hereby incorporated by reference in their entirety. Other applications that may contain teachings relevant for use with the embodiments described in this section or elsewhere in this specification may include application Ser. No. 12/886,088, titled Systems And Methods For Using Negative Pressure Wound Therapy To Manage Open Abdominal Wounds, filed Sep. 20, 2010, published as US 2011/0213287; application Ser. No. 13/092,042, titled Wound Dressing And Method Of Use, filed Apr. 21, 2011, published as US 2011/0282309; and application Ser. No. 13/365,615, titled Negative Pressure Wound Closure Device, filed Feb. 3, 2012, published as US 2012/0209227, the entireties of each of which are hereby incorporated by reference. Still more applications that may contain teachings relevant for use with the embodiments described in this specification are application Ser. No. 13/942,493, titled Negative Pressure Wound Closure Device, filed Jul. 15, 2013, published as US 2014/0180225; PCT App. No. PCT/US2013/050619, filed Jul. 16, 2013 titled Negative Pressure Wound Closure Device, published as WO 2014/014871 A1; PCT App. No. PCT/IB2013/01555, titled Devices and Methods for Treating and Closing Wounds with Negative Pressure, filed May 5, 2013, published as WO 2013/175309 A1; PCT App. No. PCT/US2014/025059, titled Negative Pressure Wound Closure Device and Systems and Methods of Use in Treating Wounds with Negative Pressure, filed Mar. 12, 2014, published as WO 2014/165275 A1; PCT App. No. PCT/GB2014/050746, Compressible Wound Fillers and Systems and Methods of Use in Treating Wounds with Negative Pressure, filed Mar. 13, 2014, published as WO 2014/140578 A1; and PCT/US2014/061627 Negative Pressure Wound Closure Device, filed Oct. 21, 2014, published as WO 2015/061352 A2. The entireties of the aforementioned applications are each hereby incorporated by reference and should be considered part of the present specification.
[0026]
[0027] In use, the wound 101 is prepared and cleaned. In some cases, such as abdominal wounds, a non- or minimally-adherent organ protection layer (not illustrated) may be applied over any exposed viscera. The wound packer 102 is then inserted into the wound, and is covered with the drape 104 so as to form a fluid-tight seal. A first end of the conduit 108 is then placed in fluidic communication with the wound, for example via the aperture 106. The second end of the conduit 108 is connected to the pump 110. The pump 110 may then be activated so as to supply negative pressure to the wound 101 and evacuate wound exudate from the wound 101. As will be described in additional detail below and in relation to the embodiments of the foregoing wound closure devices, negative pressure may also aid in promoting closure of the wound 101, for example by approximating opposing wound margins.
[0028] Any structure or component disclosed herein this section or elsewhere in the specification may comprise a radiopaque material. A radiopaque material advantageously allows a clinician to more easily find pieces of the wound closure device that may have come loose from the structure and become lost in the wound. Some examples of radiopaque materials include barium sulfate, bismuth trioxide, bismuth subcarbonate, bismuth oxychloride, and tungsten.
[0029] Stabilizing Structures and Wound Closure Devices of
[0030]
[0031] As illustrated, each cell may be defined by one or more walls, each cell having a top end and a bottom end with an opening extending through the top and bottom ends. As with the other stabilizing structures described herein this section and elsewhere in the specification, the stabilizing structure 8000 is configured to collapse by collapsing one or more cells 8001. In some embodiments, the cells are all of the same approximate shape and size when in an uncollapsed configuration. However, in other embodiments, the cells may be of different shapes and sizes when in an uncollapsed configuration.
[0032] As used in this section or elsewhere in this specification, the x direction, when referring to the stabilizing structure, generally refers to a direction or plane generally parallel to the skin surrounding the wound. The y direction, when referring to the stabilizing structure, generally refers to a direction or plane generally parallel to the skin surrounding the wound and extending perpendicular to the x direction. The z direction, when referring to the stabilizing structure, generally refers to a direction or plane extending perpendicular to the x direction and the y direction. The term width, when referring to a stabilizing structure, generally refers to a dimension of the stabilizing structure taken in the x direction along which the stabilizing structure is longest. The term length, when referring to a stabilizing structure, generally refers to a dimension of the stabilizing structure taken in the y direction along which the stabilizing structure is longest. The term height, when referring to a stabilizing structure, generally refers to a dimension of the stabilizing structure taken in the z direction along which the stabilizing structure is longest. The terms width, length, and height may also be used to describe the cells within the stabilizing structures and wound closure devices described throughout this specification. When describing these structures or devices, these terms should not be construed to require that the structures or devices necessarily be placed into a wound in a certain orientation, though in certain embodiments, it may be preferable to do so.
[0033] In some embodiments, the stabilizing structure 8000 can collapse in any manner described in this section or elsewhere in this specification with or without the application of negative pressure. For example, the stabilizing structure may collapse significantly more in one plane than in another plane upon application of negative pressure. In some embodiments, the stabilizing structure is configured to collapse more in a horizontal plane parallel to the length and width of the stabilizing structure than in a vertical plane perpendicular to the horizontal plane. In some embodiments, the stabilizing structure may collapse along the width of the stabilizing structure while remaining relatively rigid along the length of the stabilizing structure and in the vertical direction. In some embodiments, the stabilizing structure may collapse along the width of the stabilizing structure while extending along the length of the stabilizing structure and remaining relatively rigid in the vertical direction.
[0034] The stabilizing structure may be comprised of any materials described in this section or elsewhere in this specification, including: flexible plastic such as silicone, polyurethane, rigid plastics such as polyvinyl chloride, semi-rigid plastics, semi-flexible plastics, biocompatible materials, composite materials, metals, and foam. In certain embodiments, the stabilizing structure may comprise a radio opaque material, to more readily allow a clinician to find pieces of the stabilizing structure within the wound.
[0035] As illustrated in
[0036] Some embodiments of stabilizing structure 8000 may have an outer perimeter that defines an at least partially elliptical shape when placed in the wound. In some embodiments, the stabilizing structure 8000 may have an outer perimeter that defines an at least partially elliptical shape when uncollapsed. In other embodiments, the outer perimeter may not be at least partially elliptical when uncollapsed, and may become elliptical when placed in the wound. In some embodiments, the stabilizing structure 8000 may have an outer perimeter that defines an at least partially rectangular shape when uncollapsed. In some embodiments, the outer perimeter is defined by the walls of the outermost cells. In other embodiments, the outer perimeter comprises a wound wall liner 8005 that extends along the height of the stabilizing structure, in addition to surrounding the walls defining outermost cells. The wound wall liner 8005 may partially or entirely surround the outer perimeter of the stabilizing structure. In some embodiments, the wound wall liner comprises hydrophobic material. In some embodiments, the wound wall liner comprises hydrophilic material.
[0037] In some embodiments, the stabilizing structure 8000 comprises a plurality of cells 8001 that are sized and configured to collapse inwardly (e.g., toward the central longitudinal axis of the stabilizing structure) with or without the application of negative pressure. This design may provide greater overall closure of the stabilizing structure 8000 to provide for maximum closure of the wound. The cells may be designed in a manner to facilitate closure of the stabilizing structure 8000 upon the application of negative pressure. In some embodiments, the stabilizing structure comprises cells that have a hexagon shape. In some embodiments, the stabilizing structure comprises cells that collapse along the width of the stabilizing structure while remaining relatively rigid along the length of the stabilizing structure and in the vertical direction. In some embodiments, the stabilizing structure comprises cells that have a concave-hexagon shape, such as a concave-hexagon shape wherein there are two internal angles greater than 180 degrees. In some embodiments, the stabilizing structure 8000 may contain size variations between cells located within a center portion and cells located within the longitudinal end portions of the stabilizing structure 8000. For example, cells at the longitudinal end portions may be larger or smaller than cells in the center portion.
[0038] In some embodiments, the stabilizing structure is configured to collapse by more than 50%, 60%, 70%, 80% or 90% in width upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound.
Stabilizing Structures and Wound Closure Devices of FIGS. 3A-3B
[0039]
[0040] The cells 8101 of the stabilizing structure of
Stabilizing Structures and Wound Closure Devices of FIGS. 4A-4D
[0041]
Cell Configuration of Stabilizing Structures and Wound Closure Devices of FIG. 5
[0042] The shape and length of each sides of cells of a stabilizing structure may be designed to facilitate maximum collapse of the stabilizing structure along its width.
[0043] To maximize collapse of the cell 8301, in some embodiments, the sum of lengths of longitudinal walls is equal to or greater than the sum of lengths of side walls. As shown in
Stabilizing Structures and Wound Closure Devices of FIGS. 6-7B
[0044] In other embodiments shown by
[0045] Cells of the stabilizing structure described herein may be designed and configured to promote uniform collapse of the stabilizing structure within both longitudinal end portions of the stabilizing structure and a central portion between the longitudinal end portions. For example, when a stabilizing structure as described herein is positioned within a wound and placed under negative pressure, the collapsed stabilizing structure may have a substantially uniform width along the entire length of the structure, such as shown in
Stabilizing Structures and Wound Closure Devices of FIGS. 8-9
[0046] In some embodiments, the stabilizing structure may have an outer perimeter that defines an elliptical, generally elliptical, oval, generally oval, diamond, generally diamond or other shape in natural or uncollapsed state. These and other shapes may be created in some embodiments by fabricating or assembling a structure using a plurality of the cell shapes as described above, and in some embodiments the cell shapes and sizes are uniform for the entire structure. In some embodiments, as shown in
[0047] Although this disclosure describes certain embodiments, it will be understood by those skilled in the art that many aspects of the methods and devices shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. Indeed, a wide variety of designs and approaches are possible and are within the scope of this disclosure. No feature, structure, or step disclosed herein is essential or indispensable. Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), substitutions, adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection.
[0048] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
[0049] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.
[0050] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.
[0051] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
[0052] Conditional language, such as can, could, might, or may, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.
[0053] Conjunctive language such as the phrase at least one of X, Y, and Z, unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
[0054] Language of degree used herein, such as the terms approximately, about, generally, and substantially as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms approximately, about, generally, and substantially may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms generally parallel and substantially parallel refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.
[0055] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.