JP6075726B2 - Foam wound insert, wound dressing, and method having high density and low density areas - Google Patents

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority from US Provisional Patent Application No. 61 / 296,817, filed Jan. 20, 2010, the entire contents of which are incorporated herein by reference.

  The present disclosure relates generally to wound healing and wound treatment methods. More particularly, the present disclosure relates to fluid-instillation and negative pressure wound therapy.

  Clinical trials and practice have shown that providing reduced pressure near the tissue site promotes and accelerates the growth of new tissue at the tissue site. Although there are many applications of this phenomenon, the application of reduced pressure has been particularly successful in wound healing. This treatment (often referred to in the medical community as “negative pressure wound therapy”, “vacuum therapy”, or “vacuum therapy”) has many advantages, including faster healing and promotion of granulation tissue formation There is. Typically, reduced pressure is applied to the tissue through a wound insert (eg, a porous pad or other manifold device). Wound inserts typically contain bubbles or pores that can distribute a vacuum to the tissue and deliver fluid aspirated from the tissue. The wound insert can be incorporated into a wound dressing having other components that facilitate treatment, such as, for example, a drape (eg, an adhesive surgical drape).

  The present disclosure includes wound inserts having a high density region and a low density region (eg, an integrated high density region and a low density region), a wound dressing, a method for manufacturing a wound insert, and a wound treatment method.

  Some embodiments of the present method of making a wound insert compress at least a portion of a foam having a thick portion and a thin portion such that the compressed foam has a substantially constant thickness and is thick. Allowing the density of the portion to be greater than the density of the thin portion; and processing the compressed foam such that the foam remains substantially compressed in the absence of an external compressive force. .

  In some embodiments, the treating step includes heating the compressed foam to reduce the elasticity of the foam. In some embodiments, the density of the thick and thin portions is substantially the same before compressing the foam.

  In some embodiments, the treating step includes activating a coating that is dispensed on at least a portion of the foam. In some embodiments, the coating is activated by heating the foam and the coating. In some embodiments, the coating includes an adhesive. In some embodiments, the coating includes a crosslinkable polymer, and the activating step includes exposing the coating to at least one of light and high temperature to crosslink at least a portion of the crosslinkable polymer.

  Some embodiments further include the step of cooling the foam, wherein the step of cooling is performed after processing the compressed foam.

  In some embodiments, the compressed thickness of the thick portion is substantially equal to the uncompressed thickness of the thin portion. In some embodiments, after being compressed, the foam exhibits anisotropy.

  Some embodiments of the present method of manufacturing a wound insert provide a foam comprising thick and thin regions having substantially the same density; compressing at least a portion of the foam so that the foam is substantially Having a constant thickness and ensuring that the density of the thick area is greater than the density of the thin area; heating the foam to a high temperature sufficient to reduce the elasticity of the foam; and the compressed portion is Cooling the foam such that it remains substantially compressed.

  Some embodiments of the present method of making a wound insert include compressing at least a portion of the foam such that the foam has a substantially constant thickness; high temperature sufficient to reduce foam elasticity Heating the foam to; and cooling the foam such that the compressed portion remains substantially compressed, and before being compressed, the foam is a thick region having substantially the same density. And after being compressed, the density of the thick area is greater than the density of the thin area.

  In some embodiments, the foam comprises an open cell foam. In some embodiments, the foam comprises a hydrophilic (or hydrophobic) foam. In some embodiments, before being compressed, the uncompressed thickness of the thick region of the foam is greater than the uncompressed thickness of the thin region, and the compressed thickness of the thick portion is substantially equal to the uncompressed thickness of the thin portion. In some embodiments, after being compressed, the foam exhibits anisotropy.

  Some embodiments of the present method of manufacturing a wound insert provide a foam comprising thick and thin regions having substantially the same density; compressing at least a portion of the foam so that the foam is substantially Having a constant thickness and ensuring that the density of the thick region is greater than the density of the thin region; and the compressed portion remains at least partially compressed in the absence of external compression force As such, the method includes activating a coating that is dispensed into at least a portion of the foam.

  Some embodiments of the present method of making a wound insert compress at least a portion of the foam so that the foam has a substantially constant thickness; compressed in the absence of external compression force Activating the coating distributed over at least a portion of the foam such that the foam has substantially the same density before being compressed, such that the portion remains at least partially compressed. After compression, including thick and thin areas (eg, integral thick and thin areas), the density of the thick areas is greater than the density of the thin areas.

  In some embodiments, the coating includes an adhesive. In some embodiments, the coating includes a crosslinkable polymer, and the activating step includes exposing the coating to at least one of light and high temperature to crosslink at least a portion of the crosslinkable polymer.

  Some embodiments of the present wound insert are used in wound dressings and comprise a foam having a high density region and a low density region. In some embodiments, the foam comprises a hydrophilic foam. In some embodiments, the high density regions and the low density regions are arranged alternately. In some embodiments, the high density regions and the low density regions are arranged in a grid pattern.

  Some embodiments of the present wound dressing are used for wound healing using negative pressure wound therapy, with any of the present wound inserts; a drape covers the wound insert and the wound, and a space is provided between the drape and the wound. A drape connected to the patient's skin adjacent to the wound to which the dressing is applied.

  Some embodiments of the present wound insert (e.g., used in wound dressings) comprise a foam (e.g., a sterile foam) having a high density region and a low density region that is less dense than the density of the high density region. Prepare. In some embodiments, the foam is formed by any of the methods. In some embodiments, the foam comprises a hydrophilic (or hydrophobic) foam. In some embodiments, the high density regions and the low density regions are arranged alternately. In some embodiments, the high density regions and the low density regions are arranged in a grid pattern.

  Some embodiments of the wound dressing are wound inserts configured to be placed on a patient's wound, comprising a high density region and a low density region that is less dense than the density of the high density region. A wound insert comprising a foam having a foam (eg, sterile foam); to be connected to the patient's skin adjacent to the wound such that the drape covers the wound insert and the wound and forms a space between the drape and the wound And a drape configured as described above.

  Some embodiments of the wound treatment method include placing a wound insert on a patient's wound, the wound insert having a high density region and a low density region that is less dense than the density of the high density region. Providing a sterile (eg, sterile) foam having; and connecting the drape to the skin adjacent to the wound such that the drape covers the wound insert and the wound and forms a space between the drape and the wound. Including. Some embodiments further include applying a negative pressure to the wound through the wound dressing. In some embodiments, applying the negative pressure includes activating a vacuum source coupled to the wound dressing. Some embodiments further include delivering fluid to the wound through the wound dressing. In some embodiments, delivering the fluid includes activating a fluid source coupled to the wound dressing.

  Any embodiment of the present system and / or method may comprise, rather than comprise / include / contain / have, any of the foregoing steps, elements, and / or features. Or it may be essentially. Thus, in any of the claims, the term “consisting of” or “consisting essentially of” is used in place of any of the aforementioned open-ended linking verbs to define the scope of a particular claim as an open-ended It can be changed from the range when using the linking verb.

  Details regarding the foregoing and other embodiments are described below.

  The following drawings are presented for illustrative purposes and are not intended to limit the invention. For the sake of brevity and clarity, not all features of a particular structure are always shown in every figure in which the structure is described. The same reference numbers do not necessarily indicate the same structure. Rather, the same reference numbers may be used to indicate similar features or features with similar functions, as with non-identical reference numbers.

FIG. 1 shows a side view of one embodiment of the wound dressing having one of the wound inserts and coupled to a wound site and a wound treatment device. FIG. 2 shows an enlarged side view of the wound insert of FIG. FIG. 3 shows a schematic block diagram of an embodiment of a wound treatment apparatus that may comprise and / or be connected to and / or used with the present wound dressing and / or wound insert. FIG. 4 shows an end view of one embodiment of the present wound insert. FIG. 5 shows an end view of another embodiment of the wound insert. FIG. 6 shows end-face photographs of one embodiment of the wound insert in uncompressed and compressed form. FIG. 7 shows a top view photograph of the wound insert of FIG. 6 in a compressed form. FIG. 8A shows a forward monitoring infrared FLIR image of fluid movement through the wound insert embodiment and fluid movement through a prior art wound insert. FIG. 8B shows a forward monitoring infrared FLIR image of fluid movement through the wound insert embodiment and fluid movement through a prior art wound insert. FIG. 9 shows a foam suitable for an embodiment of the present wound insert cut by a laser method. FIG. 10 shows a top view of one embodiment of the wound insert showing tearing of the wound insert along the low density region. FIG. 11 illustrates one embodiment of the present circular wound insert.

  The term “coupled” is defined as being connected, but it is not necessarily direct and not necessarily mechanical; two “coupled” things May be integrated with each other. The terms “a” and “an” are defined as one or more unless otherwise specified. The terms “substantially”, “approximately” and “about” are defined as generally specified, though not necessarily completely, as will be understood by those skilled in the art.

  “Comprise” (and any form of comprising, such as “comprises” and “comprising”), “have” (and “has” and “having” any form such as “having”), “include” (and any form such as “includes” and “including”) and “contain”. The terms (and any form of containing, such as “contains” and “containing”) are open-ended linking verbs. As such, a method “comprising”, “having”, “including”, or “containing” comprising one or more steps comprises one or more of those steps, but comprises only one or more of those steps. It is not limited to doing. Similarly, a wound dressing “comprising”, “having”, “including”, or “containing” one or more elements comprises one or more of those elements, but only those elements It is not limited to. For example, in a wound dressing comprising a wound insert and a drape, the wound dressing includes the specified elements, but is not limited to having only those elements. For example, such a wound dressing may also include a connection pad configured to be coupled to a wound treatment device.

  In addition, a device or structure that is configured in a particular manner is configured at least as such, but may be configured in a manner other than that specified.

  Referring now to the drawings, and more particularly to FIG. 1, one embodiment of the present wound treatment system 10 is shown. In the illustrated embodiment, the device 10 comprises a wound treatment device 14 and a wound dressing 18 connected to the device 14 by a conduit 22. As shown, the dressing 18 is configured to be coupled to the wound 26 of the patient 30 (and is shown coupled). More particularly, in the illustrated embodiment, the dressing 18 comprises a wound insert 34 and a drape 38. As shown, the wound insert 34 is configured (and shown in a deployed state) to be disposed on the wound 26 (eg, on or adjacent to the wound surface 42). And / or the drape 38 so that the drape 38 covers the wound insert 34 and the wound 26 and forms a space 50 between the drape 38 and the wound 26 (eg, wound surface 42). To the patient's skin 46 adjacent to (and shown as connected).

  The device 14 includes, for example, a vacuum source configured to be operable (and / or operative) to apply a negative pressure to the wound dressing 18 (eg, via the conduit 22), and the wound dressing 18 A fluid source configured to be operable (and / or operative) to deliver a fluid (eg, an irrigation fluid such as a medicinal solution, an antimicrobial solution, and / or a cleaning solution) (eg, via a conduit 22). And may be provided. System 10 may be implemented and / or operated and / or coupled to patient 30 in any of a variety of configurations and / or methods similar to those described in the prior art. For example, KCI USA, Inc. Various wound therapy systems and components are commercially available through and / or from (San Antonio, Texas, USA) and / or its subsidiaries and affiliates (collectively “KCI”).

  The conduit 22 may comprise a single lumen lumen (eg, switched between a vacuum source and / or a fluid source and the device 14), or a plurality of single lumen conduits or a multi-lumen conduit. For example, fluid delivery and / or negative pressure application to the wound dressing 18 may be performed individually and / or simultaneously. In addition, the conduit 22 may include a pressure (one or more) to sense the pressure or negative pressure between the first lumen for application of negative pressure and / or fluid delivery and the drape 38 and the surface 42, for example. And at least one other lumen coupled to the sensor. In some embodiments, the conduit 22 includes a plurality of lumens (eg, a central lumen for application of negative pressure and / or fluid delivery and one or more perimeters disposed adjacent to or around the central lumen. A single lumen having a lumen and adapted to couple a surrounding lumen to the pressure sensor for sensing pressure (eg, in space 50) or negative pressure between drape 38 and surface 42. Such as in the conduits). The lumen may be arranged to have a central lumen and other lumens arranged radially around the central lumen, or may be arranged in other suitable arrangements. The lumen may also be provided in a separate conduit. In the illustrated embodiment, the system 10 further comprises a wound dressing connection pad 54 configured (and shown in a coupled state) to be coupled to the conduit 22. An example of a suitable connection pad 54 is “V.A.C.T.R.A.C.® Pad”, commercially available from KCI. An example of a suitable drape 38 includes the “VAC® drape” commercially available from KCI.

  Referring now to FIG. 2, a side view of wound insert 34 is shown. The wound insert 34 has an upper surface 100, a lower surface 104, side surfaces 108, 112 and an internal volume 116. Although only one side of the wound insert 34 is shown, those skilled in the art will appreciate that the wound insert 34 comprises a three-dimensional rectangular volume having a depth that extends perpendicular to the plane shown. . In other embodiments, the wound insert 34 may have any suitable shape, such as, for example, a cylindrical shape, an unusual shape, or the like (eg, 26 and / or wound surface 42) of a wound. It may be trimmed to fit a regular shape. The wound insert 34 may comprise a foam such as, for example, an open cell foam (which may be reticulated).

  Embodiments of the present wound treatment method can be better understood with reference to FIG. 3, which shows a schematic block diagram of one embodiment of system 10. In the illustrated embodiment, the wound dressing 18 is coupled to the device 14, and the device 14 is coupled to the canister 204 (eg, configured to receive exudate from the wound dressing 18) by a conduit 208. A vacuum source 200 (for example, a vacuum pump) is provided. In the illustrated embodiment, device 14 is further coupled to canister 204 and / or wound dressing 18 by conduit 232 and first pressure transducer 216 coupled to conduit 208 by conduit 220 and / or tee 224. A pressure sensor 212 having a second pressure transducer 228 configured. The pressure sensor 212 detects negative pressure within the wound dressing 18 and / or within the wound dressing 18, the pressure sensor 212, and / or any of the various lumens (eg, within the conduit) coupled to the vacuum source 200. It is configured as follows.

  In the illustrated embodiment, the device 14 further comprises a pressure relief valve 236 coupled to the conduit 232. Further, in the illustrated embodiment, canister 204 and vacuum source 200 are coupled to wound dressing 18 by conduit 240 and / or canister 204 prevents liquid or solid particles from entering conduit 208. Therefore, a filter 244 may be provided at the outlet of the canister 204 or in the vicinity thereof. Filter 244 may include, for example, a hydrophobic and / or lipophilic bacterial filter so that aqueous and / or oily liquids are beaded on the surface of the filter. The device 14 typically operates so that during operation, the vacuum source 200 provides sufficient airflow through the filter 244 where the pressure loss at the filter 244 is not significant (e.g. Configured so as not to substantially interfere with the application of negative pressure to the dressing 18).

  In the illustrated embodiment, the device 14 further comprises a fluid source 248 coupled to the wound dressing 18 by a conduit 252 coupled to the conduit 240, such as by a T-joint or other suitable joint 256, for example. In some embodiments, the T-joint 256 includes a switching valve or the like so as to selectively allow communication between the wound dressing 18 and the vacuum source 200 or between the wound dressing 18 and the fluid source 248. May be. In some embodiments, the device 14 includes only one of the vacuum source 200 and the fluid source 248. In embodiments of the device 14 that include only the fluid source 248, the canister 204 and / or the pressure sensor 212 may also be omitted. In various embodiments, such as those shown, conduit 232 and / or conduit 240 and / or conduit 252 may be combined and / or simply as described above with reference to FIG. It may be included in a single multi-lumen conduit. In some embodiments, the fluid source 248 is directly coupled to the wound dressing 18 (eg, the conduit 252 is coupled to the wound dressing 18 at one end, such as via the connection pad 54, and the conduit 252 is fluid at the other end. Connected to source 248; conduit 252 is not connected to T-joint 256).

  In various embodiments, such as that shown in FIG. 3, the device 14 generates a very large negative pressure (or negative pressure) in the conduit 208 as soon as the liquid in the canister reaches a level that occludes the filter 244. And may be configured to be sensed by the transducer 216. Transducer 216 interprets such a pressure change as a full canister, and signals this with an LCD message and / or buzzer that canister 204 needs to be emptied and / or replaced, and / or Alternatively, it may be connected to a circuit that automatically shuts off or disables the vacuum source 200.

  The device 14 may also apply negative pressure (or negative pressure) to the wound site (eg, continuously, intermittently, and / or periodically) and / or with a relief valve 236 at the wound site. You may be comprised so that a pressure can be rapidly made into atmospheric pressure. Thus, if the device 14 is programmed, for example, to release pressure at 10 minute intervals, at this interval the relief valve 236 opens for a specified time, equalizes the pressure at the wound site, and then closes. Negative pressure can be recovered. It will be appreciated that when a constant negative pressure is applied to the wound site, the valve 236 remains closed to prevent leakage to or from the atmosphere. In this state, the pump 200 is operated and / or operated periodically or periodically without continuously operating and / or operating to maintain a negative pressure at the wound site to achieve a desired level of negative pressure ( That is, a desired pressure below atmospheric pressure) can be maintained and detected by the transducer 216. This saves power and allows the device to operate for long periods of time with its battery power supply.

  4-7, various views of several embodiments of the present wound insert are shown. FIG. 4 shows an end view of a foam 300 that includes a thick region 304 and a thin region 308. In the illustrated embodiment, thick region 304 and thin region 308 are united (ie, contained in and defined within a single foam piece). As shown, the foam is substantially uncompressed so that the density of the thick region 304 and the thin region 308 is substantially the same. Foam 300 may include open cell foam (which may be reticulated) and / or may be hydrophilic and / or hydrophobic. The foam 300 has a trapezoidal shape, and the thick portions 304 each have a trapezoidal shape on both sides of the thin portion 308. More specifically, the thick portions 304 each have an upper surface 312 and a lower surface 316, each having a trapezoidal shape extending from the thin portion 308. In other embodiments, the thick portion 304 may extend only from one side of the thin portion 308 (eg, having only an upper surface 312 or a lower surface 316). In other embodiments, the upper and / or lower surfaces 312, 316 of each thick portion 304 may have any shape that allows the foam 300 to be compressed, processed, or used as described in the present disclosure, for example , Square, rectangular, triangular, arcuate, semi-circular, etc.

  The thickness 320 of the thick region 304 is greater than or thicker than the thickness 324 of the thin region 308. For example, the thickness 320 of the thick region 304 is 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340, 360, 380, and / or 400 percent of the thickness 324 of the thin region 308. May be equal to, greater than, less than, or between. For example, in some embodiments, the thickness 320 is 200-300 percent of the thickness 324 so that when compressed to the thickness 320, the density of the thick region 304 is 2-3 times that of the thin region 308. The thick region 304 also has a base width 328 (measured at the base of the thick region 304 and the top of the thin region 308) and a top width 332. In the illustrated embodiment, the top width 332 is less than the base width 328, and more specifically, the top width 332 is 70-80 percent of the base width 328. In other embodiments, the top width 332 is less than or equal to any of 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and / or 100 percent of the base width 328. It may be larger or between them. Further, in the illustrated embodiment, the width 336 of the thin region 308 is 30-40 percent of the base width 328 of the thick region 304. In other embodiments, the width 336 is any of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, and / or 200 percent of the base width 328. May be equal to, greater than, less than, or between. For example, in some embodiments, the width 336 is 20-50 percent of the width 328 so that when compressed, the foam 300 has less density in the low density area than in the high density area. Aspirates or aspirates fluid from a large wound area, and the low density area allows negative pressure to communicate to the wound surface.

  FIG. 5 shows an end view of another foam 350 including a thick region 354 and a thin region 358 (in the illustrated embodiment, the thick and thin regions 354, 358 are included in a single foam piece, Is defined inside). As shown, the foam 350 is substantially uncompressed so that the density of the thick region 354 and the thin region 358 is substantially the same. The foam 350 includes an open cell foam (which may be reticulated), such as a hydrophilic (or hydrophobic) foam. The foam 350 has a serrated shape, and the thick portions 354 each have a triangular shape on both sides of the thin portion 358. More specifically, the thick portions 354 each have an upper surface 362 and a lower surface 366, each having a triangular shape extending from the thin portion 358. In other embodiments, the thick portion 354 may extend only from one side of the thin portion 358 (eg, having only an upper surface 362 or a lower surface 366). In other embodiments, the upper and / or lower surfaces 362, 366 of each thick portion 354 may have any shape that allows the foam 300 to be compressed, processed, or used as described in this disclosure, for example , Square, rectangular, arcuate, semi-circular, etc.

  The thickness 370 of the thick region 354 is greater than or thicker than the thickness 374 of the thin region 358. For example, the thickness 370 of the thick region 354 is 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340, 360, 380, and / or 400 percent of the thickness 374 of the thin region 358. May be equal to, greater than, less than, or between. Thick region 354 also has a base width 378 (measured at the base of thick region 354 and the top of thin region 358). In the illustrated embodiment, the thick portion 354 has a substantially triangular shape so that the width (top width) of each thick portion at a point furthest from the thin portion 358 is substantially zero. In the illustrated embodiment, the width 386 of the thin region 358 is 30-40 percent of the base width 378 of the thick region 354. In other embodiments, the width 386 is any of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, and / or 200 percent of the base width 378. May be equal to, greater than, less than, or between.

  FIG. 6 shows an end perspective photograph of the foam 300 in an uncompressed form such as that of FIG. 4 and a compressed form in which the foam 300 is configured as a wound insert 34a. As can be seen with reference to FIG. 6, some embodiments of the present method of manufacturing a wound insert compress (and / or felt) at least a portion of a foam (eg, foam 300) so that the foam is substantially And a step of having a constant thickness (for example, a thickness of 400). Some embodiments treat the compressed foam so that the foam remains substantially compressed even in the absence of an external compressive force (e.g., applying heat or applying a coated coating). Step). For example, in some embodiments, the treating step includes heating the foam (eg, foam) to a high temperature sufficient to reduce the elasticity of the foam. For example, the elasticity of the foam may be reduced and / or relaxed, but the foam may be heated to a temperature below the melting temperature of the foam (eg, so that the foam is not degraded by high temperatures). In this way, heat and pressure (compressive force) can be used to cause compression set in the foam and relieve the compressive stress that develops in the foam. In general, high temperature is used to achieve compression set. Examples of foam materials can include polyurethanes (eg, polyethers and / or polyesters), which can be hydrophobic or hydrophilic. In order to achieve the desired “permanent set” so that the elasticity of the foam is reduced and / or the foam remains substantially compressed in the absence of compressive force, the temperature is from 158 ° F. A range of 482 degrees Fahrenheit (eg, 140 degrees Fahrenheit 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340, 360, 380, 400, 420, 440 depending on the particular form used) 460, 480, 500 degrees, greater than, less than, or between). The foam may also undergo a cooling cycle to help retain the permanent set introduced. For example, the foam may be at room temperature or below ambient temperature (e.g., at any of 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70 degrees Fahrenheit). May be cooled to, at, or at a temperature equal to, less than, greater than, or between. In some embodiments of the present method of forming a wound insert, a foam (eg, foam 300) is placed between two hot plates or hot plates (eg, in a hot plate or hot plate press, and / or heat). Place the plate where it is heated to a temperature sufficient to reduce the elasticity of the foam; actuate the press to move the hot plates towards each other (eg, perpendicular to the thickness 320 of the thick portion 304) The foam is compressed to the desired full thickness or degree of compression. Such a press may be electric, mechanical, and / or hydraulic. Other foams that may be suitable are crosslinked and / or uncrosslinked polyolefins, ethylene vinyl acetate (EVA), and acrylonitrile butadiene (NBR), polychloroprene (PCP or CR), ethylene propylene rubber (EPR & EPDM), Examples include silicones and elastomers such as fluorocarbon polymers.

  Some embodiments of the present method of manufacturing a wound insert may allow a compressed portion of the foam to remain substantially compressed at room temperature (eg, at a temperature of 72 degrees Fahrenheit) even in the absence of compressive force. As such, it also includes the step of cooling the foam (after heating the foam). In other embodiments, the step of cooling the foam is any of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, and / or 150 degrees. Equal to, less than, greater than, or applied to the foam such that the compressed portion remains substantially compressed even in the absence of compressive force at a temperature or temperature range therebetween. Cooling the applied coating. In some embodiments, prior to being compressed, the foam (eg, 300) may have a thick area (eg, 304) and a thin area (eg, 308) that have substantially the same density, and / or FIGS. 6 includes any of the other features described above with respect to foam 300 or 350; after being compressed, the density of the thick region (eg, 304) is greater than the density of the thin region (eg, 304).

  The thick and thin regions (eg, 304, 308 and 354, 358) in the foam may be formed by any suitable method such as, for example, laser cutting. For example, FIG. 9 shows a photograph of a foam sheet that has been cut into a lattice pattern by laser cutting, in a form that can be some precursor of this embodiment. For example, in the illustrated embodiment, a portion of the foam sheet may be removed along the grid pattern to define the thick and thin portions described above.

  In some embodiments, the foam is compressed such that the thickness 400 of the compressed foam 300 is substantially equal to the pre-compressed thickness 324 of the thin portion 308. In other embodiments, the thickness 400 of the compressed foam 300 (wound insert 34a) is 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 of the thickness 324 of the pre-compressed thin portion 308. And compress the foam to be less than, greater than, or between. In other embodiments, only the thick portion 304 is compressed, and the foam 300 is compressed so that the thickness 400 of the compressed foam 300 (wound insert 34a) is greater than the thickness 324 of the pre-compressed thin portion 308.

  Other embodiments of this embodiment for producing a wound insert compress at least a portion of a foam (eg, 300) such that the foam (eg, 300) has a substantially constant thickness (eg, 400). Including the steps of: In some embodiments, the step of processing the foam is such that the compressed portion remains at least partially compressed even in the absence of an external compressive force, such as at room temperature (eg, a temperature of 72 degrees Fahrenheit). Activate a coating (eg, a liquid coating such as an adhesive) that is applied or dispensed to at least a portion of the foam (eg, 300) so that it becomes (eg, remains substantially compressed) Includes steps. For example, in some embodiments, the coating can be activated (eg, dried or UV activated) to substantially maintain the compression of the foam before or after compression of the foam. A coating (eg, an adhesive or a crosslinkable polymer fluid) may be applied to the foam. In other embodiments, the step of activating the coating comprises any of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, and / or 150 degrees Fahrenheit. At a temperature equal to, less than, greater than, or between them, so that the compressed portion remains substantially compressed even in the absence of compressive force. Including the step of activating. In some embodiments, prior to being compressed, the foam (eg, 300) may have a thick area (eg, 304) and a thin area (eg, 308) that have substantially the same density, and / or FIGS. 6 includes any of the other features described above with respect to foam 300 or 350; after being compressed, the density of the thick region (eg, 304) is greater than the density of the thin region (eg, 304).

  In some embodiments, the foam is compressed such that the thickness 400 of the compressed foam 300 is substantially equal to the pre-compressed thickness 324 of the thin portion 308. In such embodiments, the coating is dispersed in the foam, such as by spraying the coating on the foam, immersing the foam in the coating, and / or any other suitable method of dispersing the coating in the foam. You may let them. In some embodiments, for example, the foam is coated with a material that exhibits a transition temperature (eg, melting point, glass transition temperature, etc.) at a relatively low temperature (eg, lower than the foam alone) or develops rigidity when dried. Also good. In some embodiments, the foam can be compressed (and / or cause compression set) at a relatively low temperature (eg, without heating) so that the foam remains in its compressed form. The coating can be configured so that the coating becomes rigid or otherwise resistant to expansion when cooled or dried. For example, a liquid adhesive may be applied to a thick part before compressing the foam and dried before removing the compressive force so that the dried adhesive is less likely to expand from the compressed thickness. In other embodiments, the coating is configured to create a compression set in the foam such that compression is reversible (eg, at least partially and / or fully reversible) when the foam warms Or it may allow the foam to expand (eg after placement in or on the wound) when it absorbs water. In some embodiments, the coating includes a crosslinkable polymer and / or the step of activating activates the coating with light and / or high temperature (eg, above ambient temperature, eg, crosslinks at least a portion of the crosslinkable polymer). Sufficient temperature) to crosslink at least a portion of the crosslinkable polymer.

  An example of a suitable coating includes a crosslinkable polymer containing n-methylolacrylamide (NMA). NMA is a monomer that can be copolymerized with many other monomers (such as acrylic and vinyl). Upon heating (eg, to about 140 ° C.), NMA reacts with itself and other hydroxyl-containing groups (eg, carboxyl). Similarly, urea formaldehyde, melamine formaldehyde, and / or phenol formaldehyde can be reacted with itself and other hydroxyl-containing polymers to form crosslinks. Other cross-linking agents include, for example, modified ethylene urea that reacts with hydroxyl-containing polymers at high temperatures to cross-link them. Other crosslinking agents can include peroxides that crosslink most polymers at high temperatures. Further, a polymer containing a hydroxyl group and a carboxyl group may be combined to form a polyester crosslink during heating. In addition, epoxy prepolymers that are less reactive at room temperature and react rapidly upon heating to form an epoxy polymer with cross-linking may be used. Similarly, polymeric isocyanates that react significantly faster only at high temperatures and in the absence of hydroxyl groups, amines, or moisture may be used.

  FIG. 7 shows a side view of wound insert 34a (compressed foam 300). As shown, the thickness of the thick region 304 increases after compression because the foam material in the thick region 304 is compressed into a small space. As such, the wound insert 304 has a compressed foam 300 (at least partially compressed--the thin portion 308 is not at all) having a high density region 404 and a low density region 408 that is less dense than the density of the high density region. It may not be compressed). More specifically, in the illustrated embodiment, the high density regions 404 and the low density regions are arranged alternately. In other embodiments, the high density regions 404 and the low density regions may be arranged in any suitable pattern, such as a lattice pattern. The wound insert may be formed by any of the methods described above.

  The combination of the high density area (eg, 404) and the low density area (eg, 408) cooperate to impart various properties to the wound insert. For example, the higher density region has a smaller total bubble size and higher bubble density, so the higher density region has improved wicking function and transports fluid more efficiently (eg, lower density region than Efficiently aspirates fluid from the wound surface and / or communicates fluid from the fluid source to the wound surface, the high density region also generally has a higher mechanical strength than the low density region, and thus the low density region and / or Structural support can be provided throughout the wound insert (eg, the wound insert will have tear resistance in a direction that is not parallel to the low density region), and the low density region is more effective bubble or pore size. The low density area is therefore more difficult to occlude, especially when negative pressure is applied to draw fluid and / or exudate from the wound through the wound insert. Because of the larger pore size, aspiration of fluid through the low density region can be performed at a higher rate than aspiration of fluid through the high density region, so that the particulate and granular materials are less dense and / or Or, it is aspirated through low density to reduce and / or reduce the likelihood of occlusion in high density areas.In some embodiments, the foam is coated with a hydrophilic material to improve the wicking characteristics of the wound insert You can also.

  The low density region may be configured to allow the wound dressing to bend and / or otherwise follow the wound. For example, the low density area is relatively bendable (and / or wound inserts can be folded so that the wound insert is folded in two and / or the wound insert follows other equipment (such as plates or pins). It may be relatively inelastic when bent or folded along the low density region. A typical single density foam wound insert is isotropic, so under negative pressure, a typical single density foam wound insert will shrink proportionally in all directions. The wound insert is configured to be anisotropic so that the wound insert can be configured to mechanically assist wound closure when contracted. For example, the low density region 408 has a lower density than the high density region (so that compression under negative pressure is greater). As such, in the embodiment of FIG. 7, when negative pressure is applied to the wound insert 34a, the low density regions 408 contract more than the high density regions 404, so that the high density regions 404 are drawn together and the wound insert 34a. Will contract laterally (perpendicular to the rows of regions 404, 408) from the longitudinal direction. As described, the wound insert may be configured to have such anisotropy, and the method may apply such negative pressure simultaneously with applying negative pressure to the wound and / or delivering fluid to the wound. The anisotropy can be used to mechanically assist wound closure and / or to apply other therapeutic strain to the wound (eg, wound surface). For example, in other embodiments, the wound insert is configured with alternating, sequentially increasing closed annular high density regions 404 such that the wound insert contracts inwardly toward its center under negative pressure. It may be configured to have a low density region 408.

  8A and 8B show the improved wicking properties or “wetting” properties of the wound insert. More specifically, FIG. 8A shows a conventional wound insert 34, a wound insert 34a formed from the foam 300 of FIG. 4 (having a trapezoidal or tapered square tooth shape), and the foam of FIG. FIG. 4 shows a front monitoring infrared (FLIR) image of wound insert 34b similarly formed from 350 (having a triangular serrated shape). FIG. 8A shows the wound insert at an initial time before fluid is delivered to the respective lower end of wound inserts 34, 34a, and 34b; FIG. 8B shows the lower end of each of wound inserts 34, 34a, and 34b. Figure 3 shows the wound insert after it has been delivered to As shown, the wound inserts 34a and 34b draw fluid faster from the lower end through each length than the conventional wound insert 34. Such improved wicking of the present wound insert can be even more pronounced when the wound inserts 34a and 34b are provided with a hydrophilic foam or coated with a hydrophilic coating. In some embodiments, in order to increase the hydrophilicity or hydrophobicity of individual regions of the foam or the entire foam, the thick portion 304, the thin portion 308, the high density region 404, and / or the low density region 408 (compressed). Coating and / or printing may be applied (before or after compression). Such coated areas may contain and / or be coated with other additives such as antibiotics or occlusion reducing agents.

  Referring now to FIGS. 10-11, there is shown an embodiment of the present wound insert showing other features of the present wound insert. FIG. 10 shows a photograph of the top surface of the wound insert 34. The wound insert 34 is configured to have anisotropy. More specifically, the high density region 404 has a greater tensile strength than the low density region 408 so that the wound insert can tear along the low density region 408 as shown. More particularly, when a tearing force is applied to the wound insert 34 (eg, by pulling the two high density regions 404 away from each other), the foam is lower between the high density regions than in any other direction. It is easy to tear along the density region 408. As such, the low density region 408 allows directional tearing without the need to perforate the foam separately (eg, reducing manufacturing costs and complexity and eliminating chips that may be formed by the perforation process). It can be described as a relatively weak zone. The low density regions 408 are provided in a row in the illustrated embodiment, but in other embodiments the low density regions may be provided in any suitable arrangement. For example, the wound insert can include low density regions 408 and high density regions 404 in the form of alternating, sequentially increasing rectangles (eg, squares), rings (eg, circles), or checkered patterns.

  FIG. 11 shows a photograph of a portion of the wound insert 34a, and more particularly a high density region 404 that has been torn or otherwise separated to include a single high density region 404, and a high density A portion of adjacent low density region 408 adjacent to region 404 is shown. As shown, the high density region 408 is mechanically strong and / or durable enough to be compressed into various shapes. For example, in the illustrated embodiment, the high density region 404 has been spiraled into a circular shape. Further, the high density region 404 can be inserted into and / or removed from the tunnel type wound without destroying the foam and / or without the foam particles disappearing in the wound. In addition, a single high density region 404 (and adjacent portions of adjacent low density regions) may be torn or removed from the wound insert 34.

  Some embodiments of the present wound dressing are configured to be placed on or in contact with a patient (eg, 30) wound (eg, 26) and / or on a wound surface (eg, 42). Wound dressings (e.g., any of the present wound dressings such as 34a, 34b, etc.), wherein the wound insert comprises a high density region (e.g., 404) and a low density region (e.g., less dense than the high density region). 408). In some embodiments, the foam is sterilized (eg, substantially free of microorganisms and / or bacteria). Some embodiments further provide that the drape covers the wound insert and the wound, creating a space between the drape and the wound (eg, as shown in FIG. 1), such as the patient's skin ( For example, a drape (eg, 38) configured to be coupled to 46).

  Some embodiments of the wound treatment method include placing a wound insert (eg, any of the wound inserts, eg, 34a, 34b, etc.) on a patient (eg, 30) wound (eg, 26). The wound insert comprises a foam (eg, 300) having a high density region (eg, 404) and a low density region (408) that is less dense than the density of the high density region. In some embodiments, the foam is sterilized (eg, substantially free of microorganisms and / or bacteria). Some embodiments further provide the drape (eg, 38) to the skin (eg, 46) adjacent to the wound such that the drape covers the wound insert and the wound and forms a space between the drape and the wound. Linking to. Some embodiments include applying negative pressure to the wound through the wound dressing (eg, through the wound insert). In some embodiments, applying negative pressure to the wound includes activating a vacuum source (eg, device 14 of FIG. 1 or vacuum source 200 of FIG. 3) coupled to the wound dressing. Some embodiments include delivering fluid to the wound through the wound dressing. In some embodiments, delivering the fluid includes activating a fluid source (eg, fluid source 248 of FIG. 3) coupled to the wound dressing.

  Some embodiments of the present wound treatment system include any embodiment of the system 10 (or any subset of the components of any embodiment of the system 10), and the wound insert and / or wound dressing. With one or more.

  The various exemplary embodiments of devices, systems, and methods described herein are not limited to the specific forms disclosed. Rather, they are intended to include all modifications and alternatives that fall within the scope of the claims.

  Unless a means-plus-function or step-plus-function limitation is explicitly recited in a particular claim using the phrase "means of" or "step of", respectively, the claim is such a limitation. And is not to be construed as such.

  It will be appreciated that the foregoing benefits and advantages may relate to one embodiment or may relate to several embodiments. Further, unless otherwise specified, when referring to “an” it will be understood that it refers to one or more of those.

  The method steps described herein may be performed in any suitable order, as appropriate, or simultaneously.

  Where appropriate, any embodiment of the foregoing embodiments, in combination with any embodiment of the other described embodiments, other embodiments having equivalent or different characteristics and addressing the same or different issues Can also be configured.

  It will be appreciated that the above description of the preferred embodiments has been given by way of example only and that various modifications may be made by those skilled in the art. The above specification, examples and data provide a complete description of the structure and use of the exemplary embodiments. Although various embodiments have been described in some detail or with reference to one or more individual embodiments, those skilled in the art will recognize many modifications to the disclosed embodiments without departing from the scope of the invention. It can be performed.

Claims (24)

A method for manufacturing a wound insert, comprising:
Compressing at least a portion of the foam having thick and thin portions such that the compressed foam has a substantially constant thickness and the density of the thick portion is greater than the density of the thin portion; And processing the compressed foam such that the foam remains substantially compressed in the absence of external compression force;
Including methods.   The method of claim 1, wherein the step of processing includes heating the compressed foam to reduce the elasticity of the foam.   The method of claim 1, wherein the density of the thick and thin portions is substantially the same before compressing the foam.   2. The method of claim 1, wherein the step of processing includes activating a coating dispensed on at least a portion of the foam.   5. The method of claim 4, wherein the coating is activated by heating the foam and the coating.   The method of claim 4, wherein the coating comprises an adhesive.   5. The method of claim 4, wherein the coating includes a crosslinkable polymer and activating the step of exposing the coating to at least one of light and high temperature to crosslink at least a portion of the crosslinkable polymer. A method comprising the steps of: In the method of any one of Claims 1-7,
Cooling the foam;
Further including
A method wherein cooling is performed after processing the compressed foam.   9. A method according to any one of the preceding claims, characterized in that the compressed thickness of the thick part is substantially equal to the uncompressed thickness of the thin part.   10. A method according to any one of the preceding claims, wherein the foam exhibits anisotropy after being compressed. A wound insert used for wound dressing,
Foam having alternating high and low density regions;
A wound insert comprising:   12. A wound insert according to claim 11, wherein the foam comprises a hydrophilic foam.   The wound insert according to claim 11, wherein the high density region and the low density region are arranged in a lattice pattern. A wound dressing used for wound healing using negative pressure wound therapy,
A wound insert according to any one of claims 11 to 13;
A drape connected to the skin of the patient adjacent to the wound to which the dressing is applied so that the drape covers the wound insert and the wound and forms a space between the drape and the wound;
Wound dressing comprising. A method for manufacturing a wound insert, comprising:
Compressing at least a portion of the foam having thick and thin regions such that the foam has a substantially constant thickness and the density of the thick regions is greater than the density of the thin regions. The thick region and the thin region have substantially the same density before the foam is compressed;
Heating the foam to an elevated temperature sufficient to reduce the elasticity of the foam; and cooling the foam such that the compressed portion remains substantially compressed;
Including methods. 16. A method according to claim 15, comprising
Providing a foam comprising thick and thin regions having substantially the same density;
The method of further comprising.   The method of claim 15 wherein the foam comprises an open cell foam.   The method of claim 17 wherein the foam comprises a hydrophilic foam.   16. The method of claim 15, wherein before compression, the uncompressed thickness of the thick region of the foam is greater than the uncompressed thickness of the thin region, and the compressed thickness of the thick portion is the uncompressed thickness of the thin portion. A method characterized by substantially equal to.   16. The method of claim 15, wherein the foam exhibits anisotropy after being compressed. A method for manufacturing a wound insert, comprising:
Providing a foam comprising thick and thin regions having substantially the same density;
Compressing at least a portion of the foam such that the foam has a substantially constant thickness and the density of the thick region is greater than the density of the thin region; Activating the coating dispensed on at least a portion of the foam such that the compressed portion remains at least partially compressed even if not present;
Including methods.   24. The method of claim 21, wherein before being compressed, the foam includes thick and thin regions having substantially the same density.   The method of claim 21, wherein the coating comprises an adhesive.   24. The method of claim 21, wherein the coating includes a crosslinkable polymer and activating the step of exposing the coating to at least one of light and high temperature to crosslink at least a portion of the crosslinkable polymer. A method comprising the steps of:

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