Debridement dressings used in conjunction with negative pressure and fluid infusion

Abstract

This application relates to a debridement dressing for use with negative pressure and fluid infusion. Systems, methods, and apparatus for debridement of tissue sites are described. The system includes a manifold adapted to form a sealed space on the tissue site for providing negative pressure and a cover. The system also includes a debridement tool positioned between the manifold and the tissue site. The debridement tool has a tissue-facing surface and a plurality of holes separated from each other by a plurality of walls. These walls have transverse surfaces extending between the tissue-facing surface and an opposite surface to form cutting edges. The holes have a perforation shape factor that allows the holes to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure to the sealed space. The cutting edges debride the tissue site in response to movement between the relaxed and contracted positions.

Description

[0001] This application is a divisional application of the application filed on May 8, 2015, with application number 202010088181.3 and invention title "Wound Cleaning Dressing for Use with Negative Pressure and Fluid Drip".

[0002] The application filed on May 8, 2015, with application number 202010088181.3 and invention title "Wound Cleaning Dressing for Use with Negative Pressure and Fluid Infusion" is a divisional application of the application filed on May 8, 2015, with application number 201580026901.0 and invention title "Wound Cleaning Dressing for Use with Negative Pressure and Fluid Infusion".

[0003] This invention claims the benefit of U.S. Provisional Patent Application Serial No. 61 / 991,134, entitled “Debriding Dressing for use with Negative Pressure and Fluid Instillation,” filed May 9, 2014, by Locke et al., entitled “Debriding Dressing for use with Negative Pressure and Fluid Instillation,” which is incorporated herein by reference for all purposes. Technical Field

[0004] The invention set forth in the appended claims generally relates to tissue treatment systems, and more specifically, but not in a limited way, to a dressing for debridement of tissue sites. background

[0005] Clinical research and practice have shown that reducing pressure near a tissue site can promote and accelerate the growth of new tissue at that site. This phenomenon has many applications, but it has proven particularly beneficial for wound treatment. Regardless of whether the wound is caused by trauma, surgery, or other reasons, proper wound care is crucial to the outcome. The use of pressure relief to treat wounds or other tissues is commonly referred to as "negative pressure therapy," but it is also known by other names, such as "negative pressure wound therapy," "decompression therapy," "vacuum therapy," and "closed negative pressure drainage." Negative pressure therapy can provide many benefits, including the migration of epithelial and subcutaneous tissues, improved blood flow, and micro-deformation of tissues at the wound site. These benefits can collectively increase granulation tissue development and reduce healing time.

[0006] While the clinical benefits of negative pressure therapy are well-known, its cost and complexity may be limiting factors in its application, and the development and operation of negative pressure systems, components, and processes have been significant challenges for manufacturers, healthcare providers, and patients.

[0007] Brief Overview

[0008] The appended claims present novel and useful systems, apparatuses, and methods for debridement of tissue in a negative pressure therapeutic environment. Several illustrative embodiments are also provided to enable those skilled in the art to make and use the claimed subject matter. For example, a system is described herein comprising a manifold adapted to deliver negative pressure to a tissue site. The system may further include a cover adapted to form a sealed space on the manifold and the tissue site for receiving negative pressure from a negative pressure source. The system may further include a debridement tool positioned between the manifold and the tissue site. The debridement tool may have a tissue-facing surface and an opposite surface, and a plurality of holes extending between the two surfaces. These holes may be separated from each other by a plurality of walls, which may have transverse surfaces extending between the tissue-facing surface and the opposite surface. These transverse surfaces may form cutting edges with the tissue-facing surface. These holes may have a perforation shape factor that allows the holes to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure to the sealed space. These cutting edges can clean tissue sites in response to the movement of the debridement tool between the relaxed and contracted positions.

[0009] Alternatively, another exemplary embodiment includes an apparatus for debridement of a tissue site. The apparatus may include a debridement tool having a tissue-facing surface and an opposite surface, comprising a plurality of holes extending between the two surfaces. These holes may be separated from each other by a plurality of walls, and these walls may have transverse surfaces extending between the tissue-facing surface and the opposite surface to form cutting edges with the tissue-facing surface. These holes may have a perforation shape factor that allows the holes to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure. These cutting edges may debride the tissue site in response to movement of the debridement tool between the relaxed position and the contracted position.

[0010] A method is also described herein, some exemplary embodiments of which include a method for debridement of a tissue site. In some embodiments, a debridement tool may be positioned such that the tissue-facing surface of the tool is adjacent to and covers the tissue site. The debridement tool may have a plurality of holes extending between the tissue-facing surface, which is separated from each other by a plurality of walls, and an opposite surface. These walls may have transverse surfaces extending between the tissue-facing surface and the opposite surface to form a cutting edge with the tissue-facing surface. The holes may have a perforation shape factor that allows the holes to collapse from a relaxed position to a contracted position, substantially perpendicular to the line of symmetry of the debridement tool. A sealing member may be positioned on the debridement tool and sealed to the tissue surrounding the tissue site to form a sealed space in which the debridement tool is located. A negative pressure source may be fluidly connected to the sealed space, and negative pressure may be applied to the sealed space to contract the debridement tool. The negative pressure may be released from the sealed space to cause the debridement tool to expand.

[0011] A system for treating a tissue site is also described herein. The system may include a manifold adapted to deliver negative pressure to the tissue site and having a first coefficient of stiffness. The system may also include a cover adapted to form a sealed space on the manifold and the tissue site for receiving negative pressure from a negative pressure source. In some embodiments, the system may include a tissue interface adapted to be positioned between the manifold and the tissue site. The tissue interface may have a second coefficient of stiffness greater than the first coefficient of stiffness and a plurality of orifices separated from each other by a plurality of walls.

[0012] This application provides the following:

[0013] 1) A system for debridement of tissue sites, comprising:

[0014] A manifold adapted to deliver negative pressure to the tissue site;

[0015] A cover adapted to form a sealed space on the manifold and the tissue site for receiving negative pressure from a negative pressure source;

[0016] A debridement tool adapted to be positioned between the manifold and the tissue site and having a tissue-facing surface and an opposite surface, including a plurality of holes extending therebetween, wherein the holes are separated from each other by a plurality of walls having transverse surfaces extending between the tissue-facing surface and the opposite surface to form a cutting edge with the tissue-facing surface, and wherein the holes have a perforation shape factor that allows the holes to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure from a sealed space; and

[0017] These cutting edges are adapted to clean the tissue site in response to the movement of the debridement tool between the relaxed and contracted positions.

[0018] 2) The system as described in 1), wherein the holes are adapted to collapse from the relaxed position to the contracted position, which is generally perpendicular to the line of symmetry of the debridement tool.

[0019] 3) The system as described in 1), wherein the holes have a perforation shape factor and a strut angle adapted to cause the holes to collapse from the relaxed position to the contracted position.

[0020] 4) The system as described in 1), wherein:

[0021] These holes are adapted to have a perforation shape factor and a strut angle that allow them to collapse from the relaxed position to the contracted position; and

[0022] These holes are adapted to be generally perpendicular to the line of symmetry of the debridement tool, collapsing from the relaxed position to the contracted position.

[0023] 5) The system as described in 3) or 4), wherein the angle of the support is approximately 90 degrees.

[0024] 6) The system as described in 3) or 4), wherein the angle of the support is less than about 90 degrees.

[0025] 7) The system as described in 1), 2), 3), 4), 5), or 6) further includes a fluid source adapted to be fluidly connected to the sealed space to provide fluid to the sealed space.

[0026] 8) The system as described in 1), 2), 3), 4), 5), 6), or 7), wherein the plurality of holes have an average effective diameter of about 5 mm.

[0027] 9) A system as described in 1), 2), 3), 4), 5), 6), 7), or 8), wherein the plurality of holes are formed in two or more parallel rows.

[0028] 10) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), or 9), wherein the perforation shape factor of each hole is less than about 1.

[0029] 11) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), or 10), wherein the thickness of the debridement tool is approximately 15 mm.

[0030] 12) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), or 11), wherein the hardness coefficient of the debridement tool is approximately 5.

[0031] 13) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), or 11), wherein the hardness coefficient of the debridement tool is approximately 3.

[0032] 14) The system described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), or 13), wherein each of the plurality of holes is hexagonal in shape.

[0033] 15) The system described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), or 13), wherein each of the plurality of holes is elliptical in shape.

[0034] 16) The system described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), or 13), wherein each of the plurality of holes is circular in shape.

[0035] 17) The system described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), or 13), wherein each of the plurality of holes is triangular in shape.

[0036] 18) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16) or 17), wherein the debridement tool includes a compressed foam.

[0037] 19) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16) or 17), wherein the debridement tool comprises a felted foam.

[0038] 20) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16) or 17), wherein the debridement tool includes a 3D spacer fabric.

[0039] 21) The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16) or 17), wherein the debridement tool comprises a thermoplastic elastomer.

[0040] 22). The system as described in 1), 2), 3), 4), 5), 6), 7), 8), 9), 10), 11), 12), 13), 14), 15), 16), or 17), wherein the debridement tool comprises a thermoplastic polyurethane.

[0041] 23) An apparatus for debridement of tissue sites, the apparatus comprising:

[0042] A tissue interface having multiple perforations separated from each other by multiple walls, wherein these perforations have a perforation shape factor adapted to cause these perforations to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure; and

[0043] The perimeter of the perforations formed by these walls is adapted to debride the tissue site in response to the movement of the tissue interface between the relaxed and contracted positions.

[0044] 24) The device as described in 23), wherein the perforations are adapted to collapse from the relaxed position to the contracted position from a line of symmetry generally perpendicular to the tissue interface.

[0045] 25) The device as described in 23), wherein the perforations have a perforation shape factor and a support angle adapted to cause the perforations to collapse from the relaxed position to the contracted position.

[0046] 26) The apparatus as described in 23, wherein:

[0047] These perforations have a perforation shape factor and a support angle adapted to cause these perforations to collapse from the relaxed position to the contracted position; and

[0048] These perforations are adapted to be generally perpendicular to the line of symmetry of the tissue interface and collapse from the relaxed position to the contracted position.

[0049] 27) The device as described in 24), 25) or 26), wherein the angle of the support is approximately 90 degrees.

[0050] 28) The device as described in 24), 25) or 26), wherein the angle of the support is less than about 90 degrees.

[0051] 29) The device as described in 23), 24), 25), 26), 27) or 28), wherein the plurality of perforations have an average effective diameter of about 5 mm.

[0052] 30) The apparatus as described in 23), 24), 25), 26), 27), 28), or 29), wherein the plurality of perforations are formed in two or more parallel rows.

[0053] 31) The apparatus as described in 23), 24), 25), 26), 27), 28), 29) or 30), wherein the perforation shape factor of each hole is less than about 1.

[0054] 32) The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30) or 31), wherein the thickness of the tissue interface is about 15 mm.

[0055] 33) The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31) or 32), wherein the hardness coefficient of the tissue interface is about 5.

[0056] 34) The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31) or 32), wherein the hardness coefficient of the tissue interface is about 3.

[0057] 35). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), or 34), wherein each of the plurality of perforations is hexagonal in shape.

[0058] 36). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), or 34), wherein each of the plurality of perforations is elliptical in shape.

[0059] 37). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), or 34), wherein each of the plurality of perforations is circular in shape.

[0060] 38). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), or 34), wherein each of the plurality of perforations is triangular in shape.

[0061] 39) The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), 34), 35), 36), 37) or 38), wherein the tissue interface comprises a compressed foam.

[0062] 40) The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), 34), 35), 36), 37) or 38), wherein the tissue interface comprises a felted foam.

[0063] 41). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), 34), 35), 36), 37), or 38), wherein the tissue interface comprises a 3D spacer fabric.

[0064] 42). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), 34), 35), 36), 37), or 38), wherein the tissue interface comprises a thermoplastic elastomer.

[0065] 43). The apparatus as described in 23), 24), 25), 26), 27), 28), 29), 30), 31), 32), 33), 34), 35), 36), 37), or 38), wherein the tissue interface comprises a thermoplastic polyurethane.

[0066] 44) A method for debridement of a tissue site, the method comprising:

[0067] Position a tissue removal tool such that the tissue-facing surface of the tissue removal tool is adjacent to and covers the tissue site;

[0068] The tissue removal tool has a plurality of holes extending between a tissue-facing surface separated from each other by a plurality of walls having transverse surfaces extending between the tissue-facing surface and the opposite surface to form a cutting edge with the tissue-facing surface, and wherein the holes have a perforation shape factor and a support angle that allow the holes to collapse from a relaxed position to a contracted position, substantially perpendicular to the line of symmetry of the tissue removal tool.

[0069] Position a sealing component on the tissue removal tool;

[0070] The sealing member is sealed to the tissue surrounding the tissue site to form a sealed space in which the tissue removal tool is located;

[0071] Connect a negative pressure fluid source to the sealed space;

[0072] Negative pressure is applied to the sealed space to cause the tissue removal tool to collapse; and

[0073] The negative pressure is released from the sealed space to loosen the tissue removal tool.

[0074] 45) The method as described in 44), wherein applying negative pressure includes: applying negative pressure to the sealed space for about 10 minutes.

[0075] 46) The method described in 44) wherein purging the sealed space includes purging the sealed space for about 1 minute.

[0076] 47) The method as described in 44), wherein the method further comprises: fluidly connecting a fluid source to the sealed space.

[0077] 48) The method as described in 47), wherein the method further comprises: supplying fluid to the sealed space using the fluid source.

[0078] 49) The method as described in 48) further comprises supplying fluid to the sealed space by: allowing the fluid to remain in the sealed space for about 5 minutes.

[0079] 50) A method for treating a tissue site, the method comprising:

[0080] Position a debridement tool with multiple holes and a hardness coefficient adjacent to and covering the tissue site;

[0081] Position a sealing component on the debridement tool;

[0082] The sealing member is sealed to the tissue surrounding the tissue site to form a sealed space containing the debridement tool;

[0083] Connect a negative pressure fluid source to the sealed space;

[0084] Negative pressure is applied to the sealed space to cause the debridement tool to contract;

[0085] Fluid is extracted from the sealed space of the tissue site through these multiple orifices; and

[0086] The negative pressure is released from the sealed space to allow the debridement tool to expand.

[0087] 51) The method as described in 50), wherein applying negative pressure comprises: applying negative pressure to the sealed space for about 10 minutes.

[0088] 52) The method described in 50) wherein purging the sealed space includes: purging the sealed space for about 1 minute.

[0089] 53) The method as described in 50), wherein the method further comprises: fluidly connecting a fluid source to the sealed space.

[0090] 54) The method as described in 53), wherein the method further comprises: supplying fluid to the sealed space using the fluid source.

[0091] 55) The method as described in 54), wherein supplying fluid to the sealed space further comprises: allowing the fluid to remain in the sealed space for about 5 minutes.

[0092] 56) A system for treating a tissue site, comprising:

[0093] A manifold adapted to deliver negative pressure to the tissue site and having a first stiffness coefficient;

[0094] A cover, adapted to form a sealed space on the manifold and the tissue site for receiving negative pressure from a negative pressure source; and

[0095] An interface adapted to be positioned between the manifold and the tissue portion, the interface having a second hardness coefficient greater than the first hardness coefficient and a plurality of pores separated from each other by a plurality of walls.

[0096] 57) The system as described in 56), wherein the holes have a perforation shape factor and a strut angle that arrange the holes in a pattern on the tissue interface.

[0097] 58) The system as described in 57), wherein the angle of the support is approximately 90 degrees.

[0098] 59) The system as described in 57), wherein the angle of the support is less than about 90 degrees.

[0099] 60) The system of any one of 57)-59), wherein the perforation shape factor of each hole is less than about 1. 61) The system of any one of 56)-60), further comprising a fluid source adapted to be fluidly coupled to the sealed space to provide fluid to the sealed space.

[0100] 62) The system as described in any one of 56)-61), wherein the plurality of holes have an average effective diameter of about 5 mm.

[0101] 63) The system as described in any one of 56)-62), wherein the plurality of holes are formed in two or more parallel rows.

[0102] 64) The system as described in any one of 56)-63), wherein the thickness of the tissue interface is about 15 mm.

[0103] 65) The system as described in any one of 56)-64), wherein the second hardness coefficient is about 5.

[0104] 66). The system as described in any one of 56)-64), wherein the second hardness coefficient is about 3.

[0105] 67) The system as described in any one of 56)-66), wherein each of the plurality of holes is hexagonal in shape.

[0106] 68) The system as described in any one of 56)-66), wherein each of the plurality of holes is elliptical in shape.

[0107] 69) The system as described in any one of 56)-66), wherein each of the plurality of holes is circular in shape.

[0108] 70) The system as described in any one of 56)-66), wherein each of the plurality of holes is triangular in shape.

[0109] 71) The system as described in any one of 56)-70), wherein the tissue interface comprises a compressed foam.

[0110] 72) The system as described in any one of 56)-70), wherein the tissue interface comprises a felted foam.

[0111] 73) The system of any one of 56)-70), wherein the interfacial structure comprises a 3D spacer fabric. 74) The system of any one of 56)-70), wherein the interfacial structure comprises a thermoplastic elastomer.

[0112] 75) The system as described in any one of 56)-70), wherein the tissue interface comprises a thermoplastic polyurethane.

[0113] 76) These systems, apparatuses, and methods are essentially as described herein. The purpose, advantages, and preferred methods of producing and using the claimed subject matter can be best understood by referring to the following detailed description of illustrative embodiments and the accompanying drawings.

[0114] Brief description of the attached diagram

[0115] Figure 1 It is a cross-sectional view showing a portion of the front view, which illustrates details that may be associated with some embodiments of a negative pressure therapy system;

[0116] Figure 1A yes Figure 1 A detailed view of a part of the negative pressure therapy system;

[0117] Figure 2 It shows that it can be used with Figure 1 A plan view showing some details of an embodiment of a debridement tool for a negative pressure therapy system in a first position;

[0118] Figure 3 It shows that it can be used with Figure 2Schematic diagram showing details of some embodiments of a hole in a debridement tool;

[0119] Figure 4 It shows that it can be used with Figure 2 Plan view showing some embodiments of these holes in the debridement tool;

[0120] Figure 5 It shows that it can be used with Figure 2 A plan view showing details related to some embodiments of the debridement tool in the second position;

[0121] Figure 6 It shows that it can be used with Figure 1 Plan view showing some detailed embodiments of another debridement tool for a negative pressure treatment system;

[0122] Figure 7 It shows that it can be used with Figure 6 Schematic diagram showing details of some embodiments of a hole in a debridement tool;

[0123] Figure 8 It shows that it can be used with Figure 6 Plan view showing some embodiments of these holes in the debridement tool;

[0124] Figure 9A It shows that it can be used with Figure 1 Plan view showing some detailed embodiments of another debridement tool for a negative pressure treatment system;

[0125] Figure 9B It shows that it can be used with Figure 9A Plan view showing some embodiments of these holes in the debridement tool;

[0126] Figure 10 It shows that it can be used with Figure 9A Schematic diagrams showing some embodiments of a debridement tool having a hole with a perforation shape factor;

[0127] Figure 11 It shows that it can be used with Figure 9A Schematic diagrams showing some embodiments of a debridement tool with a hole having another perforation shape factor;

[0128] Figure 12 It shows that it can be used with Figure 9A Schematic diagrams showing some embodiments of a debridement tool with a hole having another perforation shape factor;

[0129] Figure 13A It shows that it can be used with Figure 1 Plan view showing some detailed embodiments of another debridement tool for a negative pressure treatment system;

[0130] Figure 13B It shows that it can be used with Figure 13A Plan view showing some embodiments of these holes in the debridement tool;

[0131] Figure 14 It shows that it can be used with Figure 13A Schematic diagrams showing details related to some embodiments of a hole in a debridement tool; and

[0132] Figure 15 It shows that it can be used with Figure 1 A plan view showing some details of an embodiment of another debridement tool for a negative pressure treatment system.

[0133] Description of exemplary implementation methods

[0134] The following description of exemplary embodiments provides information that enables those skilled in the art to make and use the subject matter set forth in the appended claims, but certain details already well known in the art may be omitted. Therefore, the following detailed description should be understood as illustrative rather than restrictive.

[0135] These exemplary embodiments can also be described with reference to the spatial relationships between different elements or to the spatial orientation of the different elements depicted in these figures. Generally, such relationships or orientations assume a reference frame that is consistent with or relative to the patient to be treated. However, as those skilled in the art will recognize, this reference frame is merely a descriptive expedient and not a strict specification.

[0136] Figure 1 This is an exemplary embodiment of the treatment system 100, shown as a partial cross-sectional view in a front view, which can provide negative pressure therapy, infusion of a local treatment solution, and debridement according to this specification. The treatment system 100 may include a dressing and a negative pressure source. For example, the dressing 102 may be fluidly connected to the negative pressure source 104, such as... Figure 1 shown. Figure 1A yes Figure 1 A detailed view of a portion of the treatment system 100. (See attached image.) Figure 1 and Figure 1AAs shown, the dressing 102 includes, for example, a cover 106 and a tissue interface 107 for positioning adjacent to or near a tissue site, such as tissue site 103. In some embodiments, the tissue interface 107 may be a manifold, such as manifold 108. In some embodiments, the tissue interface 107 may be a tissue removal tool, such as a debridement tool 110 having a tissue-facing surface 111 adapted to face tissue site 103 and an opposite surface 113 adapted to face, for example, manifold 108. In other embodiments, the tissue interface 107 may be both the debridement tool 110 and the manifold 108. The treatment system 100 may also include an exudate container, such as container 112, coupled to the dressing 102 and the negative pressure source 104. In some embodiments, container 112 may be fluidly coupled to the dressing 102 via a connector 114 and a tube 116, and container 112 may be fluidly coupled to the negative pressure source 104 via a tube 118.

[0137] In some embodiments, the treatment system 100 may further include an infusion solution source. For example, the fluid source 120 may be fluidly connected to the dressing 102 via a tube 122 and a connector 124, such as... Figure 1 The exemplary embodiment is shown.

[0138] Generally, multiple components of the treatment system 100 can be directly or indirectly connected. For example, the negative pressure source 104 can be directly connected to the container 112 and indirectly connected to the dressing 102 through the container 112. Multiple components can be fluidly connected to each other to provide a path for the transfer of fluids (i.e., liquids and / or gases) between these components.

[0139] In some embodiments, for example, multiple components may be fluidly connected by a single conduit such as conduit 116, conduit 118, and conduit 122. As used herein, "conduit" broadly refers to a pipe, tube, hose, duct, or other structure having one or more lumens adapted to deliver fluid between two ends. Typically, a conduit is an elongated cylindrical structure with a degree of flexibility, but its geometry and rigidity can vary. In some embodiments, multiple components may be additionally or alternatively connected by physical proximity, forming a single structure or being formed from the same material. In some cases, the connection may also include mechanical, thermal, electrical, or chemical connections (such as chemical bonds).

[0140] Connectors such as connectors 114 and 124 can be used to fluidly connect a tube to a sealed therapeutic environment. Negative pressure generated by a negative pressure source can be delivered to a connector via a tube. In one illustrative embodiment, a connector may be available from KCI in San Antonio, Texas. Pad or Sensa A liner. In one exemplary embodiment, connector 114 may allow negative pressure generated by negative pressure source 104 to be delivered to the sealed therapeutic environment 128. In other exemplary embodiments, a connector may also be a tube inserted through a cover. In one exemplary embodiment, connector 124 may allow fluid generated by fluid source 120 to be delivered to the sealed therapeutic environment 128.

[0141] During operation, the tissue interface 107 can be placed within, above, over, or otherwise adjacent to the tissue site 103. The covering 106 can be placed above the tissue interface 107 and sealed to tissue near the tissue site. For example, the covering 106 can be sealed to the undamaged epidermis surrounding the tissue site, also known as the peritoneum. Therefore, the dressing 102 provides a sealed treatment environment 128 adjacent to the tissue site, which is substantially isolated from the external environment, and the negative pressure source 104 can reduce the pressure within the sealed treatment environment 128. The negative pressure applied to the entire tissue site 103 within the sealed treatment environment 128 through the tissue interface 107 can induce macro- and micro-strains in the tissue site 103 and remove exudates and other fluids from the tissue site 103, which can be collected in the container 112 and appropriately treated.

[0142] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location (such as within a sealed treatment environment) can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure therapy and infusion are generally well known to those skilled in the art.

[0143] Generally, fluids flow along a fluid path toward lower pressure. Therefore, the term "downstream" typically refers to a location in the fluid path closer to a negative pressure source or, alternatively, farther from a positive pressure source. Conversely, the term "upstream" generally refers to a location in the fluid path farther from a negative pressure source or closer to a positive pressure source. Similarly, the terms "inlet" or "outlet" in this frame of reference are convenient for describing certain characteristics, and the decompression process can be illustratively described here as, for example, "delivery," "distribution," or "generation" of decompression. This orientation is generally assumed to be for describing the different characteristics and components of the system here.

[0144] In this context, the term "tissue site," such as tissue site 103, broadly refers to a wound or defect located on or within a tissue, including (but not limited to) bone, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic, acute, traumatic, subacute, and laceration wounds, partial skin burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" can also refer to an area of ​​tissue that is not necessarily injured or defective, but rather an alternative area in which it may be desirable to increase or promote the growth of additional tissue. For example, negative pressure can be used in certain tissue areas to promote the growth of additional tissue that can be harvested and transplanted to another tissue location.

[0145] "Negative pressure" generally refers to pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment provided by dressing 102. In many cases, the local ambient pressure can also be atmospheric pressure at the location of the tissue site. Alternatively, this pressure can be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise stated, the pressure values ​​stated herein are gauge pressures. Similarly, references to an increase in negative pressure typically refer to a decrease in absolute pressure, while a decrease in negative pressure typically refers to an increase in absolute pressure.

[0146] A negative pressure source, such as negative pressure source 104, can be an air reservoir under negative pressure, or a manually or electrically driven device that reduces pressure within a sealed volume, such as a vacuum pump, suction pump, wall suction port used in many healthcare facilities, or micropump. The negative pressure source can be integrated into or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate negative pressure therapy. Although the amount and nature of the negative pressure applied to a tissue site can vary depending on the treatment requirements, this pressure is generally a low vacuum, often referred to as a rough vacuum, between -5 mmHg (-667 Pa) and -500 mmHg (-66.7 kPa). Common treatment ranges are between -75 mmHg (-9.9 kPa) and -300 mmHg (-39.9 kPa).

[0147] Tissue interface 107 can be generally adapted to contact a tissue site. Tissue interface 107 can be in partial or complete contact with the tissue site. If the tissue site is, for example, a wound, tissue interface 107 can partially or completely fill the wound, or can be placed on the wound. Tissue interface 107 can take many forms and can have many sizes, shapes, or thicknesses, depending on various factors such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of tissue interface 107 can be adapted to the contours of a deep and irregularly shaped tissue site. In some embodiments, tissue interface 107 can be disposed on a helical blade. Furthermore, any or all surfaces of tissue interface 107 can have a non-uniform, rough, or serrated contour that can induce microstrain and stress at the tissue site.

[0148] In some embodiments, tissue interface 107 may be a manifold, such as manifold 108. In this context, "manifold" generally includes any material or structure that provides multiple paths adapted to collect or distribute fluid throughout the tissue site under negative pressure. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure throughout the tissue site through multiple orifices, which may have the effect of collecting fluid from the entire tissue site and drawing fluid toward that source. In some embodiments, the fluid paths may be reversed or a second fluid path may be provided to facilitate fluid delivery throughout the tissue site.

[0149] In some illustrative embodiments, these paths of a manifold may be multiple interconnected channels to improve the distribution or collection of fluid throughout the tissue site. For example, honeycomb foams, open-cell foams, mesh foams, porous tissue aggregates, and other porous materials such as gauze or felt pads typically include multiple pores, edges, and / or walls adapted to form multiple interconnected fluid paths. Liquids, gels, and other foams may also include or be solidified to include multiple orifices and multiple flow channels. In some illustrative embodiments, the manifold may be a porous foam material with multiple interconnected cells or pores adapted to uniformly (or quasi-uniformly) distribute negative pressure to a tissue site. The foam material may be hydrophobic or hydrophilic. The pore size of the foam material may vary depending on the requirements of the prescribed treatment. For example, in some embodiments, manifold 108 may be a foam having a pore size in the range of about 400 micrometers to about 600 micrometers. The tensile strength of manifold 108 may also vary depending on the requirements of the prescribed treatment. For example, the tensile strength of the foam can be increased for use in infusing topical therapeutic solutions. In a non-limiting example, manifold 108 can be an open-cell mesh polyurethane foam, such as that available from Kinetic Concepts, Inc., San Antonio, Texas. In other embodiments, manifold 108 may be an open-cell mesh polyurethane foam, such as that also available from Dynamic Concepts, Inc. in San Antonio, Texas. Foam.

[0150] In one example where the tissue interface 107 can be made of a hydrophilic material, the tissue interface 107 can also wick fluid away from a tissue site while continuing to distribute negative pressure to that tissue site. The wicking property of the tissue interface 107 can draw fluid away from a tissue site through capillary flow or other wicking mechanisms. An example of a hydrophilic foam is an open-cell foam of polyvinyl alcohol, such as VAC, available from Dynamic Concepts, Inc. in San Antonio, Texas. Dressings. Other hydrophilic foams may include those made of polyether. Other foams that may exhibit hydrophilic properties include hydrophobic foams that have been treated or coated to provide hydrophilicity.

[0151] In some embodiments, the tissue interface 107 may be composed of a bioresorbable material. Suitable bioresorbable materials may include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, but is not limited to, polycarbonate, polyfuric acid ester, and caprolactone. The tissue interface 107 may further serve as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 107 to promote cell growth. Scaffolds are generally a substance or structure used to enhance or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonates, or processed allogeneic transplant materials.

[0152] In some embodiments, the cover 106 can provide a bacterial barrier and protection against physical trauma. The cover 106 can also be a sealing member made of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The cover 106 can be, for example, an elastomeric film or diaphragm that can provide a seal sufficient to maintain negative pressure at the tissue site for a given negative pressure source. In some exemplary embodiments, the cover 106 can be a water vapor-permeable but liquid-impermeable polymeric cover, such as a polyurethane film. Such covers typically have a thickness ranging from about 25 micrometers to about 50 micrometers. For permeable materials, the permeability should be generally low enough to maintain the desired negative pressure.

[0153] An attachment device can be used to attach the cover 106 to an attachment surface, such as an undamaged epidermis, liner, or another cover. The attachment device can take many forms. For example, the attachment device can be a medically acceptable pressure-sensitive adhesive that extends around the periphery of the sealing member, a portion of the sealing member, or the entire sealing member. In some embodiments, for example, a portion or all of the cover 106 can be coated with an acrylic adhesive having a coating weight between about 25 g / m² and about 65 g / m². In some embodiments, a thicker adhesive or combination of adhesives can be applied to improve sealing and reduce leakage. Other exemplary embodiments of the attachment device may include double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organic gel.

[0154] Container 112 represents a container, canister, bag, or other storage component that can be used to manage exudates and other fluids aspirated from tissue sites. In many environments, rigid containers may be preferred or necessary for the collection, storage, and treatment of fluids. In other environments, fluids can be properly treated without the need for rigid container storage, and a reusable container can reduce waste and costs associated with negative pressure therapy.

[0155] Fluid source 120 may represent a container, canister, bag, or other storage component that provides a solution for infusion therapy. The solution composition may vary depending on the prescribed treatment, but examples of solutions suitable for some prescriptions include hypochlorite-based solutions, silver nitrate (0.5%), sulfhydryl-based solutions, biguanides, cationic solutions, and isotonic solutions. In some embodiments, fluid source such as fluid source 120 may be a fluid reservoir at atmospheric pressure or higher, or a manually or electrically driven device, such as a pump, capable of delivering fluid to a sealed volume (such as a sealed treatment environment 128). In some embodiments, the fluid source may include a peristaltic pump.

[0156] Some tissue sites may fail to heal according to normal medical protocols and may develop into areas of necrotic tissue. Necrotic tissue can be dead tissue caused by infection, toxins, or trauma that causes it to die faster than normal bodily processes that regulate the removal of dead tissue. Sometimes, necrotic tissue can take the form of putrefaction, which can include viscous, fluid tissue material. Generally, putrefaction is caused by bacterial and fungal infections that stimulate an inflammatory response in the tissue. Putrefaction can be milky yellow and may also be called pus. Figure 1 As shown, necrotic tissue, such as slough 130, may cover all or part of the tissue site 103. Necrotic tissue may also include eschar, such as eschar 132. Eschar 132 may be a dehydrated and hardened portion of necrotic tissue. Eschar 132 may be the result of burns, gangrene, ulcers, fungal infections, spider bites, or anthrax. Eschar may be difficult to remove without the use of surgical cutting instruments. Necrotic tissue may also include purulent exudate and fibrinous slough.

[0157] If a tissue site develops necrotic tissue, the tissue site can be treated with a method called debridement. Debridement may involve removing dead, damaged, or infected material from the tissue site, such as purulent exudate, fibrinous necrotic tissue, slough, or eschar. In some debridement methods, a mechanical method is used to remove necrotic tissue. Mechanical methods may include using a scalpel or other cutting tools with sharp edges to remove necrotic tissue from the tissue site. Typically, mechanical methods of debridement of a tissue site can be painful and may require nutritional local anesthesia.

[0158] Debridement can also be performed using autolysis methods. Autolysis methods can involve using enzymes and water produced by the tissue site to soften and dissolve necrotic tissue. Typically, a dressing can be placed on the tissue site with necrotic tissue so that fluid produced by that tissue site can remain in place, thereby hydrating the necrotic tissue. Autolysis methods can be painless, but they are slow to take effect and can take many days. Because autolysis methods are slow, many dressing variations can also be involved. Some autolysis methods can be paired with negative pressure therapy so that negative pressure applied to the tissue site after the necrotic tissue has been hydrated can aspirate the removed necrotic tissue. In some cases, manifolds positioned at the tissue site to distribute negative pressure throughout the tissue site can be blocked or obstructed by the necrotic tissue destroyed by the autolysis method. If the manifold is blocked, negative pressure cannot aspirate the necrotic tissue, which may slow down or stop the autolysis process.

[0159] Debridement can also be performed by adding enzymes or other agents to the tissue site. These enzymes digest the tissue. Typically, strict control must be maintained over the location of the enzymes and the length of time they remain in contact with the tissue site. If the enzymes remain in the tissue site for longer than necessary, they can remove too much tissue, contaminate the tissue site, or be carried over to other areas of the patient. Once carried over to other areas, these enzymes can damage undamaged tissue and cause other complications.

[0160] These and other limitations can be addressed by a treatment system 100 that can provide negative pressure therapy, infusion therapy, and debridement. For example, in some embodiments of the treatment system 100, a negative pressure source may be fluidly coupled to a tissue site to provide negative pressure to that tissue site for negative pressure therapy. In some embodiments, a negative pressure source may be fluidly coupled to a tissue site to provide a therapeutic fluid to that tissue site for infusion therapy. In some embodiments, the treatment system 100 may include a debridement tool positioned adjacent to the tissue site. In some embodiments of the treatment system 100, the debridement tool may be used in conjunction with negative pressure therapy and infusion therapy to debride areas of tissue site containing necrotic tissue.

[0161] The treatment system 100 can be used on a tissue site 103 having necrotic tissue 130 and eschar 132. In some embodiments, a debridement tool 110 may be positioned adjacent to the tissue site 103 such that the debridement tool 110 contacts the necrotic tissue 130 and eschar 132. In some embodiments, a manifold 108 may be positioned above the debridement tool 110. In other embodiments, the manifold 108 may not be used if the depth of the tissue site 103 is approximately equal to the depth of the debridement tool 110.

[0162] In some embodiments, the debridement tool 110 has a substantially flat or substantially planar body. The debridement tool 110 may have a thickness 134. In some embodiments, the thickness 134 may be about 15 mm. In other embodiments, the thickness 134 may be thinner or thicker than about 15 mm, depending on the needs of the tissue site 103. In some embodiments, individual portions of the debridement tool 110 may have a minimum tolerance from the thickness 134. In some embodiments, the thickness 134 may have a tolerance of about 2 mm. The debridement tool 110 may be flexible such that the debridement tool 110 may conform to the contour of the surface of the tissue site 103.

[0163] In some embodiments, the debridement tool 110 may be formed from a thermoplastic elastomer (TPE) such as a styrene-ethylene-butene-styrene (SEBS) copolymer or a thermoplastic polyurethane (TPU). The debridement tool 110 may be formed by combining sheets of TPE or TPU. In some embodiments, the sheets of TPE or TPU may be bonded, welded, glued, or otherwise joined together. For example, in some embodiments, the sheets of TPE or TPU may be welded using radiant heat, radio frequency welding, or laser welding. Supracor Ltd., Hexacor Inc., Hexcel Corp., and Econocorp Ltd. may manufacture suitable TPE or TPU sheets for forming the debridement tool 110. In some embodiments, a TPE or TPU sheet having a thickness between about 0.2 mm and about 2.0 mm may be used to form a structure having a thickness of 134. In some embodiments, the debridement tool 110 may be formed from a 3D fabric (also known as a spacer fabric). Suitable 3D fabrics may be manufactured by HeathcoatFabrics Inc., Baltex, and the Mueller Textil Group.

[0164] In some embodiments, the debridement tool 110 may be formed from a type of foam. For example, honeycomb foam, open-cell foam, mesh foam, or porous tissue aggregates may be used to form the debridement tool 110. In some embodiments, the debridement tool 110 may be made from... Grey foam or Zotefoam is formed. Grey foam can be a polyester polyurethane foam with approximately 60 pores per inch (ppi). Zotefoam can be a closed-cell cross-linked polyolefin foam. In a non-limiting example, the debridement tool 110 can be an open-cell mesh polyurethane foam, such as that available from Dynamic Concepts, Inc., San Antonio, Texas. Dressing; in other embodiments, the debridement tool 110 may be an open-cell mesh polyurethane foam, such as VAC, which is also available from Dynamic Concepts, Inc. in San Antonio, Texas. Foam.

[0165] In some embodiments, the debridement tool 110 may be formed from foam whose density is increased by mechanical or chemical compression under ambient pressure. The mechanically or chemically compressed foam may be referred to as compressed foam. A characteristic of compressed foam may be a stiffness factor (FF) defined as the ratio of the density of the foam in a compressed state to the density of the same foam in an uncompressed state. For example, a stiffness factor (FF) of 5 may refer to a compressed foam having a density five times greater than that of the same foam in an uncompressed state. Mechanically or chemically compressing foam can reduce the thickness of the foam under ambient pressure compared to the same uncompressed foam. Reducing the thickness of the foam by mechanical or chemical compression can increase the density of the foam, thereby increasing the stiffness factor (FF) of the foam. Increasing the stiffness factor (FF) of the foam can increase the stiffness of the foam in a direction parallel to the thickness of the foam. For example, increasing the stiffness factor (FF) of the debridement tool 110 can increase the stiffness of the debridement tool 110 in a direction parallel to the thickness 134 of the debridement tool 110. In some embodiments, a compressed foam may be a compressed… It has approximately 0.03 g / cm³ in its uncompressed state. 3 (g / cm 3 The density of ). If It is compressed to have a hardness coefficient (FF) of 5. It can be compressed until Its density is approximately 0.15 g / cm³. 3 . The foam can also be compressed to form a compressed foam with a hardness coefficient (FF) of up to 5. In some embodiments, the debridement tool 110 may have a thickness of about 8 mm, and if the debridement tool 110 is positioned within a sealed treatment space 128 and subjected to a negative pressure of about -125 mmHg, the thickness 134 of the debridement tool 110 may be greater than about 3 mm.

[0166] Compressed foam can also be called felted foam. Like compressed foam, felted foam undergoes a thermoforming process to permanently compress the foam, thereby increasing its density. A felted foam can also be compared to other felted or compressed foams by comparing its hardness coefficient to that of other compressed or uncompressed foams. Typically, a compressed or felted foam can have a hardness coefficient greater than 1.

[0167] The stiffness coefficient (FF) can also be used to compare compressed foam materials with non-foam materials. For example, Materials may have permitted A stiffness factor (FF) compared to compressed foam. In some embodiments, the stiffness factor (FF) of a non-foam material may represent the stiffness of the non-foam material being equivalent to that of a compressed foam having the same stiffness factor. For example, if a wound cleaning tool is made of... As shown in Table 1 below, the debridement tool possesses stiffness and a compressibility coefficient (FF) of 3. The materials have approximately the same stiffness.

[0168] Generally, if a compressed foam is subjected to negative pressure, it exhibits less deformation than a similar uncompressed foam. In the case where the debridement tool 110 is formed from a compressed foam, the thickness 134 of the debridement tool 110 can deform less than if it were formed from a comparative uncompressed foam. This reduction in deformation can be caused by increased stiffness, as reflected by the coefficient of stiffness (FF). When subjected to negative compressive stress, the debridement tool 110 formed from compressed foam is less flat than that formed from uncompressed foam. Therefore, when negative pressure is applied to the debridement tool 110, the stiffness of the debridement tool 110 in the direction parallel to its thickness 134 allows for greater adaptability or compressibility in other directions, such as perpendicular to the thickness 134. The foam material used to form the compressed foam can be hydrophobic or hydrophilic. The pore size of the foam material can vary depending on the needs of the debridement tool 110 and the amount of foam compression. For example, in some embodiments, the uncompressed foam may have a pore size in the range of about 400 micrometers to about 600 micrometers. If the same foam is compressed, the pore size may be smaller than that of the foam in its uncompressed state.

[0169] Figure 2 This is a plan view illustrating additional details that may relate to some embodiments of the debridement tool 110. The debridement tool 110 may include a plurality of holes 140 or perforations extending through the debridement tool 110 to form a plurality of walls 148 extending through the debridement tool 110. In some embodiments, these walls 148 may be parallel to the thickness 134 of the debridement tool 110. In other embodiments, these walls 148 may be substantially perpendicular to the tissue-facing surface 111 and the opposite surface 113 of the debridement tool 110. In some embodiments, the holes 140 may have a hexagonal shape as shown. In other embodiments, the holes 140 may have a circular, elliptical, triangular, square, irregular, or amorphous shape.

[0170] In some embodiments, the debridement tool 110 may have a first calibration line 136 and a second calibration line 138 perpendicular to the first calibration line 136. The first calibration line 136 and the second calibration line 138 may be lines of symmetry for the debridement tool 110. A line of symmetry may be, for example, a dashed line passing through the tissue-facing surface 111 or the opposite surface 113 of the debridement tool 110, defining a zigzag line such that if the debridement tool 110 folds along the line of symmetry, the hole 140 and the wall 148 will be simultaneously aligned. Generally, the first calibration line 136 and the second calibration line 138 help to describe the debridement tool 110. In some embodiments, the first calibration line 136 and the second calibration line 138 may be used to indicate a desired direction of contraction for the debridement tool 110. For example, the desired direction of contraction may be parallel to the second calibration line 138 and perpendicular to the first calibration line 136. In other embodiments, the desired direction of contraction may be parallel to the first calibration line 136 and perpendicular to the second calibration line 138. In other embodiments, the desired direction of contraction may be at a non-perpendicular angle to the first calibration line 136 and the second calibration line 138. Generally, the debridement tool 110 can be placed at the tissue site 103 such that the second calibration line 138 extends through it. Figure 1 Rotten flesh 130 and eschar 132.

[0171] Although the debridement tool 110 is shown as a generally rectangular shape having a longitudinal edge 144 and a lateral edge 146, the debridement tool 110 may also have other shapes. For example, the debridement tool 110 may have a rhomboid, square, or circular shape. In some embodiments, the shape of the debridement tool 110 may be selected to suit the type of tissue site to be treated. For example, the debridement tool 110 may have an elliptical or circular shape to suit an elliptical or circular tissue site. In some embodiments, the first alignment line 136 may be parallel to the longitudinal edge 144.

[0172] More precisely see Figure 3The diagram illustrates a single hole 140 having a hexagonal shape. Hole 140 may include a center 150 and a perimeter 152. Hole 140 may have a perforation shape factor (PSF). The perforation shape factor (PSF) may represent the orientation of hole 140 relative to a first calibration line 136 and a second calibration line 138. Generally, the perforation shape factor (PSF) is the ratio of half the maximum length of hole 140 parallel to the desired contraction direction to half the maximum length of hole 140 perpendicular to the desired contraction direction. For illustrative purposes, the desired contraction direction is parallel to the second calibration line 138. The desired contraction direction may be indicated by a debridement force 142. For reference, hole 140 may have an X-axis 156 extending through the center 150 between opposite vertices of the hexagon and parallel to the first calibration line 136, and a Y-axis 154 extending through the center 150 between opposite vertices of the hexagon and parallel to the second calibration line 138. The perforation shape factor (PSF) of hole 140 can be defined as the ratio of line segment 158 ​​extending from center 150 to perimeter 152 of hole 140 on Y-axis 154 to line segment 160 extending from center 150 to perimeter 152 of hole 140 on X-axis 156. If the length of line segment 158 ​​is 2.69 mm and the length of line segment 160 is 2.5 mm, then the perforation shape factor (PSF) will be 2.69 / 2.5 or approximately 1.08. In other embodiments, hole 140 may be oriented relative to first calibration line 136 and second calibration line 138 such that the perforation shape factor (PSF) may be approximately 1.07 or 1.1.

[0173] refer to Figure 4 , showed Figure 1This is part of a debridement tool 110. The debridement tool 110 may include a plurality of holes 140 aligned in parallel rows. The parallel row pattern may include a first row 162, a second row 164, and a third row 166 of holes 140. The center 150 of the holes 140 in adjacent rows, such as the first row 162 and the second row 164, is characterized by being offset from a second calibration line 138 along a first calibration line 136. In some embodiments, a line connecting the centers of adjacent rows may form a strut angle (SA) with the first calibration line 136. For example, a first hole 140A in the first row 162 may have a center 150A, and a second hole 140B in the second row 164 may have a center 150B. A strut line 168 may connect centers 150A and 150B. The strut line 168 may form an angle 170 with the first calibration line 136. Angle 170 may be a strut angle (SA) of the debridement tool 110. In some embodiments, the strut angle (SA) may be less than about 90°. In other embodiments, the strut angle (SA) may be between about 30° and about 70° relative to the first calibration line 136. In other embodiments, the strut angle (SA) may be about 66° relative to the first calibration line 136. Generally, as the strut angle (SA) decreases, the stiffness of the debridement tool 110 in the direction parallel to the first calibration line 136 can decrease. Increasing the stiffness of the debridement tool 110 parallel to the first calibration line 136 can increase the compressibility of the debridement tool 110 perpendicular to the first calibration line 136. Therefore, if negative pressure is applied to the debridement tool 110, the debridement tool 110 can have greater adaptability or compressibility in the direction perpendicular to the first calibration line 136. By increasing the compressibility of the debridement tool 110 in the direction perpendicular to the first calibration line 136, the debridement tool 110 can collapse to apply the debridement force 142 to the tissue site 103, as described in more detail below.

[0174] In some embodiments, the centers 150 of holes 140 in alternating rows, such as the center 150A of a first hole 140A in a first row 162 and the center 150C of a hole 140C in a third row 166, are spaced apart from each other by a length 172 parallel to the second calibration line 138. In some embodiments, the length 172 may be greater than the effective diameter of the hole 140. If the centers 150 of holes 140 in alternating rows are separated by the length 172, then the wall 148 parallel to the first calibration line 136 can be considered continuous. Generally, the wall 148 can be continuous if it does not have discontinuities or breaks between holes 140.

[0175] Regardless of the shape of the hole 140, the hole 140 in the debridement tool 110 can leave void space within the debridement tool 110 and on the tissue-facing surface 111 and the opposite surface 113 of the debridement tool 110, such that only the wall 148 of the debridement tool 110 belongs to the surface that can be used to contact the tissue site 103. It may be desirable to minimize the wall 148 so that the hole 140 can collapse, thereby causing the debridement tool 110 to collapse and generate a debridement force 142 in a direction perpendicular to the first calibration line 136. However, it may also be desirable not to minimize the wall 148 too much, such that the debridement tool 110 is too brittle to maintain the application of negative pressure. The void space percentage (VS) of the hole 140 may be equal to the percentage of the volume or surface area of ​​the void space on the tissue-facing surface 111 created by the hole 140 relative to the total volume or surface area of ​​the tissue-facing surface 111 of the debridement tool 110. In some embodiments, the void space percentage (VS) may be between about 40% and about 60%. In other embodiments, the void space percentage (VS) may be approximately 55%.

[0176] In some embodiments, these holes 140 may be formed during the molding process of the debridement tool 110. In other embodiments, the holes 140 may be formed after the debridement tool 110 has been formed by cutting, melting, or vaporizing the debridement tool 110. For example, the holes 140 may be formed in the debridement tool 110 by laser cutting compressed foam of the debridement tool 110. In some embodiments, the effective diameter of the holes 140 may be selected to allow microparticles to flow through the holes 140. The effective diameter of a non-circular region is defined as the diameter of a circular region having the same surface area as the non-circular region. In some embodiments, each hole 140 may have an effective diameter of about 3.5 mm. In other embodiments, each hole 140 may have an effective diameter between about 5 mm and about 20 mm. The effective diameter of the holes 140 should be distinguished from the porosity of the material forming the wall 148 of the debridement tool 110. Generally, the effective diameter of the holes 140 is on the order of magnitude larger than the effective diameter of the pores in the material forming the debridement tool 110. For example, the effective diameter of the aperture 140 can be greater than about 1 mm, while the wall 148 can be composed of pores with a size of less than about 600 micrometers. Material formation. In some embodiments, the pores in the wall 148 may not form an opening that extends through the material.

[0177] Now for reference Figure 2 and Figure 4The holes 140 can be patterned according to their geometry and the alignment of the holes 140 between adjacent and alternating rows in the cleaning tool 110 relative to the first calibration line 136. If the cleaning tool 110 is subjected to negative pressure, the holes 140 of the cleaning tool 110 can collapse. In some embodiments, the void space percentage (VS), perforation shape factor (PSF), and strut angle (SA) can cause the cleaning tool 110 to contract along a second calibration line 138 perpendicular to the first calibration line 136, such as... Figure 5 As shown in more detail below. If the debridement tool 110 is positioned on the tissue site 103, the debridement tool 110 can generate a debridement force 142 along the second calibration line 138, from the contraction of the debridement tool 110, such as Figure 5 As shown in more detail below. The debridement force 142 can be optimized by adjusting the above-mentioned coefficients as stated in Table 1 below. In some embodiments, the orifice 140 may be hexagonal, having a pillar angle (SA) of approximately 66°, a void space percentage (VS) of approximately 55%, a stiffness coefficient (FF) of approximately 5, a perforation shape factor (PSF) of approximately 1.07, and an effective diameter of approximately 5 mm. If the debridement tool 110 is subjected to a negative pressure of approximately -125 mmHg, the debridement force 142 applied by the debridement tool 110 is approximately 13.3 N. If the effective diameter of the orifice 140 of the debridement tool 110 is increased to 10 mm, the debridement force 142 is reduced to approximately 7.5 N.

[0178] refer to Figure 5 The debridement tool 110 is in the second position or the retracted position, as indicated by the debridement force 142. During operation, negative pressure is applied to the sealed treatment environment 128 via the negative pressure source 104. In response to the application of negative pressure, the debridement tool 110... Figure 2 The relaxed position shown contracted to Figure 5 The contraction position is shown. Overall, the thickness 134 of the debridement tool 110 remains essentially the same. When the negative pressure is removed, for example, by evacuating the negative pressure, the debridement tool 110 expands back to the relaxed position. If the debridement tool 110 is respectively in Figure 5 The position of contraction and Figure 2 Cycling between relaxed positions, the tissue-facing surface 111 of the debridement tool 110 debrides the tissue site 103 by removing dead or contaminated tissue (including necrotic tissue 130 and eschar 132) from the wound. The edges of the holes 140 formed by the tissue-facing surface 111 and the transverse surfaces of the wall 148 create cutting edges for debridement of the tissue site 103, allowing the excised tissue to drain into the container 112 through the holes 140 and the manifold 108 after negative pressure is applied. In some embodiments, the cutting edges are defined by a perimeter 152, wherein each hole 140 extends through the tissue-facing surface 111.

[0179] In some embodiments, the treatment system 100 can provide cyclic treatment. Cyclic treatment may alternately apply negative pressure to and from the sealed treatment environment 128. In some embodiments, negative pressure may be applied to the sealed treatment environment 128 until the pressure in the sealed treatment environment 128 reaches a predetermined treatment pressure. If negative pressure is applied to the sealed treatment environment 128, the debridement tool 110, as... Figure 5 The treatment environment 128 may be sealed under treatment pressure for a predetermined treatment period, such as about 10 minutes. In other embodiments, the treatment period may be longer or shorter than required to apply appropriate negative pressure to the tissue site 103.

[0180] After the treatment period, the sealed treatment environment 128 can be emptied. For example, a negative pressure source 104 can fluidly connect the sealed treatment environment 128 to the atmosphere (not shown), thereby allowing the sealed treatment environment 128 to return to ambient pressure. In some embodiments, the negative pressure source 104 can empty the sealed treatment environment 128 for approximately 1 minute. In other embodiments, the negative pressure source 104 can empty the sealed treatment environment 128 for a longer or shorter period. In response to restoring the sealed treatment environment 128 to ambient pressure by emptying the sealed treatment environment 128, the debridement tool 110 expands, thereby returning to ambient pressure. Figure 2 The relaxed position. The contraction and expansion of the debridement tool 110 causes the cutting edge of the debridement tool 110 to debride the tissue site 103 as described above. When negative pressure is applied to the sealed treatment environment 128 by the negative pressure source 104, the removed excised tissue portions (including necrotic tissue 130 and eschar 132) can be extracted through the hole 140.

[0181] In some embodiments, infusion therapy may be combined with negative pressure therapy. For example, after a period of negative pressure therapy, fluid source 120 may operate to provide fluid to sealed treatment environment 128. In some embodiments, fluid source 120 may provide fluid while negative pressure source 104 empties sealed treatment environment 128. For example, fluid source 120 may include a pump configured to move infusion fluid from fluid source 120 to sealed treatment environment 128. In other embodiments, negative pressure source 104 may not empty sealed treatment environment 128. Instead, negative pressure in sealed treatment environment 128 is used to draw infusion fluid from fluid source 120 into sealed treatment environment 128.

[0182] In some embodiments, fluid source 120 may provide a volume of fluid into a sealed treatment environment 128. In some embodiments, the fluid volume may be the same as the volume of the sealed treatment environment 128. In other embodiments, the fluid volume may be smaller or larger than the sealed treatment environment 128 as needed to appropriately apply infusion therapy. In some embodiments, the fluid provided by fluid source 120 may be maintained in the sealed treatment environment 128 for a certain residence time. In some embodiments, the residence time is approximately 5 minutes. In other embodiments, the residence time may be longer or shorter than required to appropriately apply the infusion therapy to the tissue site 103. The residence time may be referred to as the residence time of a treatment cycle.

[0183] After the residence time ends, negative pressure source 104 can be activated to draw the infusion fluid into container 112, thus completing one treatment cycle. As the infusion fluid is removed from the sealed treatment environment 128 by negative pressure, negative pressure can also be applied to the sealed treatment environment 128 to begin another treatment cycle.

[0184] In each treatment cycle provided by the negative pressure source 104, the debridement tool 110 can contract and expand. With each treatment cycle, the tissue-facing surface 111 of the debridement tool 110 is abradeed through the tissue site 103 by a debridement force 142. The abrade action of the debridement tool 110 by the debridement force 142 causes the cutting edge of the hole 140 to expel portions of necrotic tissue 130 and eschar 132. With each subsequent treatment cycle, additional portions of necrotic tissue 130 and eschar 132 are removed from the tissue site 103 by the debridement force 142. The expelled granular portions of necrotic tissue 130 and eschar 132 may be small enough to be extracted from the tissue site 103 by negative pressure treatment. If infusion treatment is also provided, fluid from the fluid source 120 can also help remove the debridement tissue. Infusion treatment can also clean the manifold 108, thereby preventing the manifold 108 from being blocked by the removed necrotic tissue 130 and eschar 132.

[0185] Figure 6 This is a plan view illustrating additional details that may relate to some embodiments of the debridement tool 210. The debridement tool 210 may be similar to the debridement tool 110 and as described above relative to... Figures 1-5The debridement tool 210 is described above. Similar elements may have similar reference numbers indexed up to 200. For example, the debridement tool 210 is shown as a generally rectangular shape including a longitudinal edge 244 and a lateral edge 246. The debridement tool 210 may have a first calibration line 236 and a second calibration line 238 perpendicular to the first calibration line 236. In some embodiments, the first calibration line 236 and the second calibration line 238 may be used to indicate a desired direction of contraction for the debridement tool 210. For example, the desired direction of contraction may be parallel to the second calibration line 238 and perpendicular to the first calibration line 236, as indicated by the debridement force 142. In other embodiments, the desired direction of contraction may be perpendicular to the second calibration line 238 and parallel to the first calibration line 236. In other embodiments, the desired direction of contraction may be non-perpendicular to both the second calibration line 238 and the first calibration line 236. Generally, the debridement tool 210 can be placed at the tissue site 103 such that the tissue-facing surface 211 of the debridement tool 210 can cover the portion of the tissue site 103 having necrotic tissue 130 or eschar 132. The debridement tool 210 may include a plurality of holes 240 or perforations extending through the debridement tool 210 to form a plurality of walls 248 extending through the debridement tool 210. In some embodiments, these walls 248 are parallel to the thickness 234 of the debridement tool 210. These walls 248 may have transverse surfaces that intersect with the tissue-facing surface 211 to form cutting edges. In some embodiments, the holes 240 may have a circular shape as shown.

[0186] More precisely see Figure 7 The diagram illustrates a single hole 240 having a circular shape. Hole 240 may include a center 250, a perimeter 252, and a perforation shape factor (PSF). For reference, hole 240 may have an X-axis 256 extending through center 250 parallel to a first calibration line 236 and a Y-axis 254 extending through center 250 parallel to a second calibration line 238. In some embodiments, the perforation shape factor (PSF) of hole 240 may be defined as the ratio of a line segment 258 extending from center 250 to perimeter 252 of hole 240 on Y-axis 254 to a line segment 260 extending from center 250 to perimeter 252 of hole 240 on X-axis 256. If the length of line segment 258 is 2.5 mm and the length of line segment 260 is 2.5 mm, then the perforation shape factor (PSF) will be 2.5 / 2.5 or approximately 1.

[0187] refer to Figure 8 , showed Figure 6 This is part of a debridement tool 210. The debridement tool 210 may include a plurality of holes 240 with parallel row patterns aligned. The parallel row patterns may include a first row 262 of holes 240, a second row 264 of holes 240, and a third row 266 of holes 240. Figure 7The X-axis 256 of each hole 240 can be parallel to Figure 8 The first calibration line 236. The center 250 of the hole 240 in adjacent rows, such as the first row 262 and the second row 264, is characterized by being offset from the second calibration line 238 along the first calibration line 236. In some embodiments, a line connecting the centers of adjacent rows may form a support angle (SA) with the first calibration line 236. For example, the first hole 240A in the first row 262 may have a center 250A, and the second hole 240B in the second row 264 may have a center 250B. Support line 268 may connect centers 250A and centers 250B. Support line 268 may form an angle 270 with the first calibration line 236. Angle 270 may be the support angle (SA) of the cleaning tool 210. In some embodiments, the support angle (SA) may be less than about 90°. In other embodiments, the support angle (SA) may be between about 30° and about 70° relative to the first calibration line 236. As described above, if negative pressure is applied to the debridement tool 210, the debridement tool 210 can have greater adaptability or compressibility in the direction perpendicular to the first calibration line 236. By increasing the compressibility of the debridement tool 210 in the direction perpendicular to the first calibration line 236, the debridement tool 210 can collapse to apply debridement force to the tissue site 103, as described in more detail below.

[0188] In some embodiments, the centers 250 of holes 240 in alternating rows, such as the center 250A of a first hole 240A in a first row 262 and the center 250C of a hole 240C in a third row 266, are spaced apart from each other by a length 272 parallel to the second calibration line 238. In some embodiments, the length 272 may be greater than the effective diameter of the hole 240. If the centers 250 of holes 240 in alternating rows are separated by the length 272, then the wall 248 parallel to the first calibration line 236 can be considered continuous. Generally, the wall 248 can be continuous if it does not have discontinuities or breaks between holes 240.

[0189] Regardless of the shape of the hole 240, the hole 240 in the debridement tool 210 can leave void space within the debridement tool 210 and on the tissue-facing surface 211 of the debridement tool 210, such that only the wall 248 of the debridement tool 210 belongs to the surface that can be used to contact the tissue site 103. It may be desirable to minimize the wall 248 so that the hole 240 collapses, thereby causing the debridement tool 210 to collapse to generate a debridement force 142 in a direction perpendicular to the first calibration line 236. However, it may also be desirable not to minimize the wall 248 too much, so that the debridement tool 210 is too brittle to maintain the application of negative pressure. The void space percentage (VS) of the hole 240 may be equal to the percentage of the volume or surface area of ​​the void space on the tissue-facing surface 211 created by the hole 240 relative to the total volume or surface area of ​​the tissue-facing surface 211 of the debridement tool 210. In some embodiments, the void space percentage (VS) may be between about 40% and about 60%. In other embodiments, the void space percentage (VS) may be approximately 54%.

[0190] In some embodiments, the diameter of the orifice 240 can be selected to allow particle flow through the orifice 240. In some embodiments, each orifice 240 may have a diameter of about 5 mm. In other embodiments, each orifice 240 may have an effective diameter between about 3.5 mm and about 20 mm.

[0191] Now for reference Figure 7 and Figure 8 The holes 240 can be patterned according to the geometry of the holes 240 and the alignment of the holes 240 with respect to the first calibration line 236 between adjacent and alternating rows in the debridement tool 210. If the debridement tool 210 is subjected to negative pressure, the holes 240 of the debridement tool 210 may collapse. In some embodiments, the void space percentage (VS), perforation shape factor (PSF), and strut angle (SA) can cause the debridement tool 210 to collapse along a second calibration line 238 perpendicular to the first calibration line 236. The debridement force 142 can be optimized by adjusting the above coefficients as stated in Table 1 below. In some embodiments, the holes 240 may be circular, having a strut angle (SA) of about 37°, a void space percentage (VS) of about 54%, a stiffness factor (FF) of about 5, a perforation shape factor (PSF) of about 1, and a diameter of about 5 mm. If the debridement tool 210 is subjected to a negative pressure of approximately -125 mmHg, then the debridement tool 210 applies a debridement force 142 of approximately 11.9 N. If the diameter of the hole 240 of the debridement tool 210 is increased to approximately 20 mm, then the void percentage (VS) becomes approximately 52%, the strut angle (SA) becomes approximately 52°, and the perforation shape factor (PSF) and stiffness factor (FF) remain the same, the debridement force 142 decreases to approximately 6.5 N.

[0192] Figure 9A This is a plan view illustrating additional details that may relate to some embodiments of the debridement tool 310. The debridement tool 310 may be similar to the debridement tool 110 and as described above relative to... Figures 1-5 The device operates as described. Similar elements may have similar reference numbers indexed up to 300. The debridement tool 310 may cover the tissue site 103. In some embodiments, the debridement tool 310 may have a first calibration line 336 and a second calibration line 338 perpendicular to the first calibration line 336. In some embodiments, the first calibration line 336 and the second calibration line 338 may be used to indicate a desired direction of contraction of the debridement tool 310. For example, the desired direction of contraction may be parallel to the second calibration line 338 and perpendicular to the first calibration line 336. In other embodiments, the desired direction of contraction may be perpendicular to the second calibration line 338 and parallel to the first calibration line 336. In other embodiments, the desired direction of contraction may be at a non-perpendicular angle to the second calibration line 338 and the first calibration line 336. Generally, the debridement tool 310 may be positioned at the tissue site 103 such that the tissue-facing surface 311 of the debridement tool 310 may cover the portion of the tissue site 103 having necrotic tissue 130 and eschar 132. The debridement tool 310 may include a plurality of holes 340 or perforations extending through the debridement tool 310 to form a plurality of walls 348 extending through the debridement tool 310. In some embodiments, these walls 348 are parallel to the thickness 334 of the debridement tool 310. These walls 348 may have transverse surfaces that intersect with the tissue-facing surface 311 to form a cutting edge. In some embodiments, the holes 340 may have an oval shape as shown.

[0193] More precisely see Figure 10 The diagram illustrates a single hole 340 having an oval shape. Hole 340 may include a center 350, a perimeter 352, and a perforation shape factor (PSF). For reference, hole 340 may have an X-axis 356 extending through center 350 parallel to a first calibration line 336 and a Y-axis 354 extending through center 350 parallel to a second calibration line 338. In some embodiments, the perforation shape factor (PSF) of hole 340 may be defined as the ratio of a line segment 358 extending from center 350 to perimeter 352 of hole 340 on Y-axis 354 to a line segment 360 extending from center 350 to perimeter 352 of hole 340 on X-axis 356. If the length of line segment 358 is 2.5 mm and the length of line segment 360 is 2.5 mm, then the perforation shape factor (PSF) will be 2.5 / 2.5 or approximately 1.

[0194] refer to Figure 11If hole 340 is rotated relative to the first calibration line 336 and the second calibration line 338 such that the principal axis of hole 340 is parallel to the second calibration line 338 and the minor axis of hole 340 is parallel to the first calibration line 336, the perforation shape factor (PSF) can change. For example, the perforation shape factor (PSF) is now defined as the ratio of line segment 376 extending from center 350 to the perimeter 352 of hole 340 on the Y-axis 354 to line segment 378 extending from center 350 to the perimeter 352 of hole 340 on the X-axis 356. If the length of line segment 376 is 5 mm and the length of line segment 378 is 2.5 mm, then the perforation shape factor (PSF) will be 5 / 2.5, or approximately 2.

[0195] refer to Figure 12 If hole 340 is rotated relative to the first calibration line 336 and the second calibration line 338, such that the principal axis of hole 340 is parallel to the first calibration line 336 and the minor axis of hole 340 is parallel to the second calibration line 338, then the perforation shape factor (PSF) can change. For example, the perforation shape factor (PSF) is now defined as the ratio of line segment 380 extending from center 350 to the perimeter 352 of hole 340 on the Y-axis 354 to line segment 382 extending from center 350 to the perimeter 352 of hole 340 on the X-axis 356. If the length of line segment 380 is 2.5 mm and the length of line segment 382 is 5 mm, then the perforation shape factor (PSF) will be 2.5 / 5, or approximately 1 / 2.

[0196] refer to Figure 9B , showed Figure 9A This is part of a debridement tool 310. The debridement tool 310 may include a plurality of holes 340 with parallel row patterns aligned. The parallel row patterns may include a first row 362 of holes 340, a second row 364 of holes 340, and a third row 366 of holes 340. Figure 10 , Figure 11 and Figure 12 The X-axis 356 of each hole 340 can be parallel to Figure 9BThe first calibration line 336. The center 350 of the hole 340 in adjacent rows, such as the first row 362 and the second row 364, is characterized by being offset from the second calibration line 338 along the first calibration line 336. In some embodiments, a line connecting the centers of adjacent rows may form a support angle (SA) with the first calibration line 336. For example, the first hole 340A in the first row 362 may have a center 350A, and the second hole 340B in the second row 364 may have a center 350B. Support line 368 may connect centers 350A and 350B. Support line 368 may form an angle 370 with the first calibration line 336. Angle 370 may be the support angle (SA) of the cleaning tool 310. In some embodiments, the support angle (SA) may be less than about 90°. In other embodiments, the support angle (SA) may be between about 30° and about 70° relative to the first calibration line 336. As described above, if negative pressure is applied to the debridement tool 310, the debridement tool 310 can have greater adaptability or compressibility in the direction perpendicular to the first calibration line 336. By increasing the compressibility of the debridement tool 310 in the direction perpendicular to the first calibration line 336, the debridement tool 310 can collapse to apply the debridement force 142 to the tissue site 103, as described in more detail below.

[0197] In some embodiments, the centers 350 of holes 340 in alternating rows, such as the center 350A of a first hole 340A in a first row 362 and the center 350C of a hole 340C in a third row 366, are spaced apart from each other by a length 372 parallel to the second calibration line 338. In some embodiments, the length 372 may be greater than the effective diameter of the hole 340. If the centers 350 of holes 340 in alternating rows are separated by the length 372, then the wall 348 parallel to the first calibration line 336 can be considered continuous. Generally, the wall 348 can be continuous if it does not have discontinuities or breaks between holes 340.

[0198] Regardless of the shape of the orifice 340, the orifice 340 in the debridement tool 310 can leave void space within the debridement tool 310 and on the tissue-facing surface 311 of the debridement tool 310, such that only the wall 348 of the debridement tool 310 belongs to the surface that can be used to contact the tissue site 103. It may be desirable to minimize the wall 348 so that the orifice 340 can collapse, thereby causing the debridement tool 310 to collapse and generate a debridement force 142 in a direction perpendicular to the first calibration line 336. However, it may also be desirable not to minimize the wall 348 too much, so that the debridement tool 310 is too brittle to maintain the application of negative pressure. The void space percentage (VS) of the orifice 340 may be equal to the percentage of the volume or surface area of ​​the void space on the tissue-facing surface 311 created by the orifice 340 relative to the total volume or surface area of ​​the tissue-facing surface 311 of the debridement tool 310. In some embodiments, the void space percentage (VS) may be between about 40% and about 60%. In other embodiments, the void space percentage (VS) may be approximately 56%.

[0199] In some embodiments, the effective diameter of the aperture 340 can be selected to allow particle flow through the aperture 340. In some embodiments, each aperture 340 may have an effective diameter of about 7 mm. In other embodiments, each aperture 340 may have an effective diameter between about 2.5 mm and about 20 mm.

[0200] Now for reference Figure 9A and Figure 9B The holes 340 can be patterned according to their geometry and the alignment of the holes 340 between adjacent and alternating rows in the debridement tool 310 relative to the first calibration line 336. If the debridement tool 310 is subjected to negative pressure, the holes 340 of the debridement tool 310 can collapse, causing the debridement tool 310 to collapse along a second calibration line 338 perpendicular to the first calibration line 336. If the debridement tool 310 is positioned on the tissue site 103, the debridement tool 310 can generate a debridement force 142 along the second calibration line 338, causing the debridement tool 310 to contract in the same direction to debride the tissue site 103. The debridement force 142 can be optimized by adjusting the coefficients described in Table 1 below. In some embodiments, the hole 340 may be oval, having a pillar angle (SA) of approximately 47°, a void space percentage (VS) of approximately 56%, a hardness factor (FF) of approximately 5, a perforation shape factor (PSF) of approximately 1, and an effective diameter of approximately 7 mm (where the main axis is approximately 10 mm and the minor axis is approximately 5 mm). If the debridement tool 310 is subjected to a negative pressure of approximately -125 mmHg, the debridement tool 310 applies a debridement force 142 of approximately 13.5 N.

[0201] Figure 13AThis is a plan view illustrating additional details that may relate to some embodiments of the debridement tool 410. The debridement tool 410 may be similar to the debridement tool 110 and, as relative to... Figures 1-5 The device operates as described. Similar elements may have similar reference numbers indexed up to 400. For example, a debridement tool 410 is shown as a generally rectangular shape including a longitudinal edge 444 and a lateral edge 446. The debridement tool 410 may cover tissue site 103. In some embodiments, the debridement tool 410 may have a first calibration line 436 and a second calibration line 438 perpendicular to the first calibration line 436. In some embodiments, the first calibration line 436 and the second calibration line 438 may be used to indicate a desired direction of contraction of the debridement tool 410. For example, the desired direction of contraction may be parallel to the second calibration line 438 and perpendicular to the first calibration line 436. In other embodiments, the desired direction of contraction may be perpendicular to the second calibration line 438 and parallel to the first calibration line 436. In other embodiments, the desired direction of contraction may be at a non-perpendicular angle to the second calibration line 438 and the first calibration line 436. Generally, the debridement tool 410 can be placed at the tissue site 103 such that the tissue-facing surface 411 of the debridement tool 410 can cover the portion of the tissue site 103 having necrotic tissue 130 or eschar 132. The debridement tool 410 may include a plurality of holes 440 or perforations extending through the debridement tool 410 to form a plurality of walls 448 extending through the debridement tool 410. In some embodiments, these walls 448 are parallel to the thickness 434 of the debridement tool 410. These walls 448 may have transverse surfaces that intersect with the tissue-facing surface 411 to form cutting edges. In some embodiments, the holes 440 may have a triangular shape as shown.

[0202] More precisely see Figure 14 The diagram illustrates a single hole 440 having a triangular shape. Hole 440 may include a center 450, a perimeter 452, and a perforation shape factor (PSF). In some embodiments, hole 440 may include a first vertex 484, a second vertex 486, and a third vertex 488. For reference, hole 440 may have an X-axis 456 extending through center 450 parallel to a first calibration line 436 and a Y-axis 454 extending through center 450 parallel to a second calibration line 438. In some embodiments, the perforation shape factor (PSF) of hole 440 may be defined as the ratio of a line segment 458 extending from center 450 to perimeter 452 of hole 440 on Y-axis 454 to a line segment 460 extending from center 450 to perimeter 452 of hole 440 on X-axis 456. If the length of segment 458 is 1.1 mm and the length of segment 460 is 1 mm, then the perforation shape factor (PSF) will be 1.1 / 1 or approximately 1.1.

[0203] refer to Figure 13B , showed Figure 13A This is part of a debridement tool 410. The debridement tool 410 may include a plurality of holes 440 with parallel row patterns aligned. The parallel row patterns may include a first row 462 of holes 440, a second row 464 of holes 440, and a third row 466 of holes 440. Figure 14 The X-axis 456 of each hole 440 can be parallel to Figure 13B The first calibration line 436. In some embodiments, the first hole 440A in the first row 462 can be oriented such that the first vertex 484A is between the first calibration line 436 and one side of the first hole 440A opposite to the first vertex 484A. The hole 440C adjacent to the first hole 440A in the first row 462 can be oriented such that the first vertex 484C is oriented relative to the first hole 440A.

[0204] The center 450 of a hole 440 having a first vertex 484 oriented in the same direction in adjacent rows, such as first row 462 and second row 464, is characterized by being offset from a second calibration line 438 along a first calibration line 436. In some embodiments, a line connecting the centers 450 of adjacent rows may form a strut angle (SA) with the first calibration line 436. For example, a first hole 440A in first row 462 may have a center 450A, and a second hole 440B in second row 464 may have a center 450B and a first vertex 484B. A strut line 468 may connect centers 450A and 450B. The strut line 468 may form an angle 470 with the first calibration line 436. Angle 470 may be the strut angle (SA) of the cleaning tool 410. In some embodiments, the strut angle (SA) may be less than about 90°. In other embodiments, the strut angle (SA) may be between about 40° and about 70° relative to the first calibration line 436. As described above, if negative pressure is applied to the debridement tool 410, the debridement tool 410 can have greater adaptability or compressibility in the direction perpendicular to the first calibration line 436. By increasing the compressibility of the debridement tool 410 in the direction perpendicular to the first calibration line 436, the debridement tool 410 can collapse to apply the debridement force 142 to the tissue site 103, as described in more detail below.

[0205] Regardless of the shape of the hole 440, the hole 440 in the debridement tool 410 can leave void space within the debridement tool 410 and on the tissue-facing surface 411 of the debridement tool 410, such that only the wall 448 of the debridement tool 410 belongs to the surface that can be used to contact the tissue site 103. It may be desirable to minimize the wall 448 so that the hole 440 can collapse, thereby causing the debridement tool 410 to collapse to generate a debridement force 142 in a direction perpendicular to the first calibration line 436. However, it may also be desirable not to minimize the wall 448 too much, so that the debridement tool 410 is too brittle to maintain the application of negative pressure. The void space percentage (VS) of the hole 440 may be equal to the percentage of the volume or surface area of ​​the void space on the tissue-facing surface 411 created by the hole 440 relative to the total volume or surface area of ​​the tissue-facing surface 411 of the debridement tool 410. In some embodiments, the void space percentage (VS) may be between about 40% and about 60%. In other embodiments, the void space percentage (VS) may be approximately 56%.

[0206] In some embodiments, the effective diameter of the aperture 440 can be selected to allow particle flow through the aperture 440. In some embodiments, each aperture 440 may have an effective diameter of about 7 mm. In other embodiments, each aperture 440 may have an effective diameter between about 2.5 mm and about 20 mm.

[0207] Now for reference Figure 13A and Figure 13B The holes 440 can be patterned according to their geometry and the alignment of the holes 440 between adjacent and alternating rows in the debridement tool 410 relative to the first calibration line 436. If the debridement tool 410 is subjected to negative pressure, the holes 440 of the debridement tool 410 can collapse. In some embodiments, the void space percentage (VS), perforation shape factor (PSF), and strut angle (SA) can cause the debridement tool 410 to collapse along a second calibration line 438 perpendicular to the first calibration line 436. If the debridement tool 410 is positioned on the tissue site 103, the debridement tool 410 can generate a debridement force 142 along the second calibration line 438, causing the debridement tool 410 to contract in the same direction. The debridement force 142 can be optimized by adjusting the aforementioned coefficients as described in Table 1 below. In some embodiments, the hole 440 may be triangular, having a strut angle (SA) of approximately 63°, a void space percentage (VS) of approximately 40%, a hardness factor (FF) of approximately 5, a perforation shape factor (PSF) of approximately 1.1, and an effective diameter of approximately 10 mm. If the debridement tool 410 is subjected to a negative pressure of approximately -125 mmHg, the debridement tool 410 may apply a debridement force 142 of approximately 13.5 N.

[0208] Figure 15This is a plan view illustrating additional details that may relate to some embodiments of the debridement tool 510. The debridement tool 510 may be similar to the one described above relative to... Figures 1-5 The aforementioned debridement tool 110. The debridement tool 510 may include stripes 516 and stripes 518. In some embodiments, the debridement tool 510 may be made of a material similar to... The foam is formed. In some embodiments, stripe 518 may be formed by compressing a portion of the foam so that stripe 516 has a first density and stripe 518 has a second density. In some embodiments, for example, the second density is greater than the first density. In some embodiments, the second density may be between about 3 and about 5 times greater than the first density. For example, stripe 516 may be an uncompressed foam, and stripe 518 may be a compressed foam with a stiffness coefficient of about 5. Generally, stripe 516 has greater compressibility than stripe 518. In some embodiments, stripe 516 and stripe 518 may be oriented vertically relative to the tissue site, and in other embodiments, stripe 516 and stripe 518 may be oriented horizontally relative to the tissue site. In other embodiments, stripe 516 and stripe 518 may be oriented at an angle relative to the tissue site. The foam material of the debridement tool 510 may have cutting edges formed by pores in the foam material, which are positioned on the tissue-facing surface 511 of the debridement tool 510. If the debridement tool 510 is placed under negative pressure, stripe 516 may collapse before stripe 518. In some embodiments, if stripe 516 collapses, the debridement tool 510 contracts perpendicular to stripe 516. If the debridement tool 510 cycles between a contracted state and a relaxed state as described above, the cutting edge of the pore can debride the tissue in a manner similar to the cutting edge of the debridement tool 110 as described above.

[0209] The debridement force, such as debridement force 142, generated by a debridement tool, such as debridement tool 110, can be related to the compressive force generated by applying negative pressure under treatment pressure to a sealed treatment environment. For example, debridement force 142 can be proportional to the product of the treatment pressure (TP) in the sealed treatment environment 128, the compressibility factor (CF) of debridement tool 110, and the surface area (A) of the tissue-facing surface 111 of debridement tool 110. The relationship is expressed as follows:

[0210] Cure capacity α (TP*CF*A)

[0211] In some embodiments, the therapeutic pressure TP is expressed in N / m 2 The compressibility factor (CF) is dimensionless, while the area (A) is measured in meters. 2The debridement force is measured in Newtons (N). The compressibility factor (CF) resulting from applying negative pressure to the debridement tool can be a dimensionless number, for example, proportional to the product of the porosity percentage (VS) of the debridement tool, the stiffness factor (FF) of the debridement tool, the strut angle (SA) of the orifice in the debridement tool, and the perforation shape factor (PSF) of the orifice in the debridement tool. The relationship is expressed as follows:

[0212] Compression factor (CF) α(VS*FF*sin(SA)*PSF)

[0213] Based on the above formula, debridement tools made of different materials with holes of different shapes were manufactured and tested to determine their debridement force. For each debridement tool, the treatment pressure TP was approximately -125 mmHg and the tool dimensions were approximately 200 mm x 53 mm, such that the surface area (A) of the debridement tool facing the tissue was approximately 106 cm². 2 or 0.0106m 2 Based on the two equations above, a hardness coefficient (FF) of 3 is... The debridement force of the debridement tool 110 is approximately 13.3, of which... The debridement tool 110 has a hexagonal hole 140 with a distance of 5 mm between two opposite vertices, a perforation shape factor (PSF) of 1.07, a support angle (SA) of approximately 66°, and a void space percentage of approximately 55%. Similar sized... The debridement tool 110 generates a debridement force of approximately 9.1 Newtons (N) 142.

[0214]

[0215]

[0216] In some embodiments, the above formula cannot accurately describe the debridement force because the force is lost as it is transferred from the debridement tool to the wound. For example, the modulus and stretch of the covering 106, the modulus of the tissue portion 103, the sliding of the covering 106 on the tissue portion 103, and the friction between the debridement tool 110 and the tissue portion 103 can cause the actual value of the debridement force 142 to be less than the calculated value of the debridement force 142.

[0217] The systems, devices, and methods described herein offer several significant advantages. For example, combining the mechanical friction of a debridement tool with the hydration and irrigation effects of infusion and negative pressure therapy can achieve painless or minimally invasive debridement of tissue sites. The debridement tools described herein also require less monitoring by clinicians or other on-call personnel compared to other mechanical and enzymatic debridement methods. Furthermore, the debridement tools described herein are not blocked by the removed necrotic tissue during autolytic debridement of tissue sites.

[0218] Although illustrated in some of the illustrative embodiments, those skilled in the art will recognize that the systems, apparatuses, and methods described herein are readily adaptable and subject to various changes and modifications. Furthermore, descriptions using different alternatives to terms such as “or” need not be mutually exclusive unless the context clearly requires it, and the indefinite articles “a” or “an” do not limit the subject matter to a single instance unless the context clearly requires it.

[0219] The appended claims set forth several novel and inventive aspects of the subject matter described above; however, the claims may also cover other subject matter not explicitly enumerated in detail. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish these novel and inventive features from those known to a person skilled in the art. The features, elements, and aspects described herein may also be combined or replaced by alternative features for the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.

Claims

1. A debridement tool comprising a felted foam and adapted to be positioned at a tissue site, wherein the debridement tool has a tissue-facing surface and an opposite surface, the debridement tool comprising a plurality of pores extending between the tissue-facing surface and the opposite surface, characterized in that, The plurality of holes are separated from each other by walls having transverse surfaces extending between the tissue-facing surface and the opposite surface, the transverse surfaces forming a cutting edge with the tissue-facing surface, and wherein the plurality of holes have a perforation shape factor and a strut angle of 90 degrees, the perforation shape factor being the ratio of half the maximum length of the holes in the plurality of holes parallel to the desired contraction direction to half the maximum length of the holes in the plurality of holes perpendicular to the desired contraction direction, the perforation shape factor and the strut angle allowing the plurality of holes to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure when the debridement tool is positioned between the manifold and the tissue site, in a sealed space formed by the cover over the manifold and the tissue site; and The cutting edge is adapted to clean the tissue site in response to the movement of the cleaning tool between the relaxed position and the contracted position.

2. The debridement tool according to claim 1, wherein the plurality of holes are adapted to collapse from the relaxed position to the contracted position in a direction generally perpendicular to the line of symmetry of the debridement tool.

3. The debridement tool according to claim 1, wherein the plurality of holes have an average effective diameter of about 5 mm.

4. The debridement tool according to claim 1, wherein the plurality of holes are formed in two or more parallel rows.

5. The debridement tool according to claim 1, wherein the perforation shape factor of each hole is less than 1.

6. The debridement tool according to claim 1, wherein the thickness of the debridement tool is approximately 15 mm.

7. The debridement tool according to claim 1, wherein the hardness coefficient of the debridement tool is approximately 5.

8. The debridement tool according to claim 1, wherein the hardness coefficient of the debridement tool is approximately 3.

9. The debridement tool according to claim 1, wherein each of the plurality of holes is hexagonal in shape.

10. The debridement tool according to claim 1, wherein each of the plurality of holes is elliptical in shape.

11. The debridement tool according to claim 1, wherein each of the plurality of holes is circular in shape.

12. The debridement tool according to claim 1, wherein each of the plurality of holes is triangular in shape.

13. An apparatus for debridement of tissue sites, the apparatus comprising: A manifold adapted to deliver negative pressure to the tissue site; A cover adapted to form a sealed space on the manifold and the tissue site for receiving negative pressure from a negative pressure source; as well as The debridement tool according to any one of claims 1 to 12 is positioned between the manifold and the tissue site.

14. An apparatus for debridement of a tissue site, the apparatus comprising: An organizational interface having an organizational surface and an opposite surface; as well as Multiple perforations, the multiple perforations being separated from each other by walls having transverse surfaces that intersect with the tissue-facing surface to form cutting edges; The plurality of perforations have a perforation shape factor configured to collapse from a relaxed position to a contracted position in response to the application and removal of negative pressure. This perforation shape factor is the ratio of half the maximum length of a perforation parallel to the desired contraction direction to half the maximum length of a perforation perpendicular to the desired contraction direction. The cutting edge debridees the tissue site in response to the movement of the tissue interface between the relaxed and contracted positions.

15. The device of claim 14, wherein the plurality of perforations are adapted to collapse from the relaxed position to the contracted position on a line of symmetry generally perpendicular to the tissue interface.

16. The apparatus of claim 14, wherein the plurality of perforations have a strut angle, and the perforation shape factor and the strut angle are configured to cause the plurality of perforations to collapse from the relaxed position to the contracted position.

17. The apparatus according to claim 14, wherein: The multiple perforations have a support angle; The perforation shape factor and the support angle are configured to cause the plurality of perforations to collapse from the relaxed position to the contracted position; and The multiple perforations are configured to collapse from the relaxed position to the contracted position, generally perpendicular to the line of symmetry of the tissue interface.

18. The device according to claim 16, wherein the angle of the support is approximately 90 degrees.

19. The apparatus of claim 16, wherein the angle of the support column is less than 90 degrees.

20. The device of claim 14, wherein the plurality of perforations have an average effective diameter of about 5 mm.

21. The apparatus of claim 14, wherein the plurality of perforations are formed in two or more parallel rows.

22. The apparatus of claim 14, wherein the perforation shape factor of each perforation is less than 1.

23. The apparatus of claim 14, wherein the thickness of the tissue interface is about 15 mm.

24. The apparatus of claim 14, wherein the hardness coefficient of the tissue interface is about 5.

25. The apparatus of claim 14, wherein the hardness coefficient of the tissue interface is about 3.

26. The apparatus of claim 14, wherein each of the plurality of perforations is hexagonal in shape.

27. The apparatus of claim 14, wherein each of the plurality of perforations is elliptical in shape.

28. The apparatus of claim 14, wherein each of the plurality of perforations is circular in shape.

29. The apparatus of claim 14, wherein each of the plurality of perforations is triangular in shape.

30. The apparatus of claim 14, wherein the tissue interface comprises a compressed foam.

31. The apparatus of claim 14, wherein the tissue interface comprises a felted foam.

32. The apparatus of claim 14, wherein the tissue interface comprises a 3D spacer fabric.

33. The apparatus of claim 14, wherein the tissue interface comprises a thermoplastic elastomer.

34. The apparatus of claim 14, wherein the tissue interface comprises a thermoplastic polyurethane.

35. An apparatus for debridement of tissue sites, the apparatus comprising: A tissue interface formed of a foam material having multiple pores forming a cutting edge in the surface of the tissue interface, the surface of the tissue interface being configured to be positioned adjacent to the tissue site. A first plurality of stripes, the first plurality of stripes having a first density, the first plurality of stripes being horizontally oriented relative to the surface; A second plurality of stripes, having a second density, are oriented horizontally relative to the surface; and The tissue interface is configured to contract perpendicularly to the first plurality of stripes and the second plurality of stripes between a relaxed position and a contracted position in response to the application and removal of negative pressure; and The cutting edge is configured to debride the tissue site in response to movement of the tissue interface between the relaxed and contracted positions.

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