The present disclosure relates generally to wound dressings. More specifically, the present disclosure relates to wound dressings for negative pressure wound therapy systems.
NPWT is a therapeutic technique used to promote healing in acute or chronic tissue wounds. NPWT systems are configured to apply a negative pressure to a wound, through a dressing that is connected to the wound (e.g., to the skin surrounding the wound). The negative pressure may be utilized to remove infectious materials, and to help promote wound closure and healing. In order to maintain adequate pressure at the wound site, the dressing must form an airtight seal with the patient's tissue. In some instances, it may be desirable to remove the dressing from the wound during treatment to inspect the state of the wound and assess healing progress. This process requires removal of the dressing from the patient, which may degrade the adhesive used to secure the dressing and renders the dressing unusable. It would be desirable to provide a device that allows for inspection of the wound without sacrificing the dressing.
One implementation of the present disclosure is a dressing for a negative wound pressure therapy system. The dressing includes a patient interface layer, a first fastening layer, a second fastening layer, and an upper cover. The patient interface layer defines an opening. The first fastening layer is coupled to the patient interface layer. The second fastening layer is detachably coupled to the first fastening layer such that the second fastening layer can be separated from and reattached to the first fastening layer while still forming a substantially airtight seal with the first fastening layer. The upper cover is coupled to the second fastening layer and covers the opening.
In some embodiments, the first fastening layer and the second fastening layer together form a substantially airtight seal between the patient interface layer and the upper cover when the first fastening layer is coupled to the second fastening layer.
In some embodiments, the first fastening layer includes a strip extending along a perimeter portion of the opening. The strip may include a plurality of stems that are configured to mechanically fasten the first fastening layer to the second fastening layer when the first fastening layer is pressed against the second fastening layer. The strip may also include a pressure sensitive adhesive disposed in between adjacent ones of the stems.
In some embodiments, the first fastening layer includes a male interlocking member. The second fastening layer may include a female interlocking member configured to sealingly engage with the male interlocking member. In some instances, the first fastening layer includes both a non-adhesive-based mechanical fastener and an adhesive material.
In some embodiments, the first fastening layer is disposed along a perimeter of the opening. The first fastening layer may include a first fastening strip and a second fastening strip that is positioned on an opposite side of the opening as the first fastening strip. The first fastening strip and the second fastening strip may be oriented in a direction that is substantially parallel to a longest dimension of the opening. In some instances, the dressing may further include a gel adhesive that is disposed between the patient interface layer and the upper cover and that extends between the first fastening strip and the second fastening strip.
In some embodiments, the dressing further includes an absorbent material that is disposed between the upper cover and the patient interface layer. The absorbent material may be aligned with the opening. In some embodiments, one end of the upper cover is permanently bonded to the patient interface layer.
Another implementation of the present disclosure is a negative pressure wound dressing with selective viewing access and reclosure system. The dressing includes a patient interface layer defining an opening configured for placement about a patient area of treatment, a top layer sized to cover the opening and including a negative pressure interface, a touch fastener disposed between the patient interface layer and the top layer, and a negative pressure source coupled to the negative pressure interface on the top layer. The touch fastener is configured to detachably couple the patient interface layer to the top layer and to form a substantially airtight seal between the patient interface layer and the top layer.
Yet another implementation of the present disclosure is a method of making a dressing for a negative pressure wound therapy system. The method includes providing a patient interface layer defining an opening, a first fastening layer, an upper cover sized to cover the opening, and a second fastening layer. The method additionally includes joining the first fastening layer to the patient interface layer and joining the second fastening layer to the upper cover. The method further includes coupling the upper cover to the patient interface layer by pressing the second fastening layer against the first fastening layer to form a substantially airtight seal between the first fastening layer and the second fastening layer.
In some embodiments, joining the first fastening layer to the patient interface layer includes positioning a strip along a perimeter portion of the opening, and bonding the strip to the patient interface layer.
In some embodiments, coupling the upper cover to the patient interface layer includes pressing a female interlocking member of the second fastening layer into a male interlocking member of the first fastening layer.
In some embodiments, joining the first fastening layer to the patient interface layer includes positioning a first fastening strip along a direction that is substantially parallel to a longest dimension of the opening, joining the first fastening strip to the patient interface layer on a first side of the opening, joining a second fastening strip to a second side of the opening opposite the first side, and applying a gel adhesive to the patient interface layer to substantially fill a gap between the first fastening strip and the second fastening strip.
In some embodiments, the method further includes placing an absorbent material into a recessed area of the upper cover, and aligning the absorbent material with the opening.
Those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the detailed description set forth herein and taken in conjunction with the accompanying drawings.
Referring generally to the Figures, a dressing with a removable and resealable reclosure system for a negative pressure wound therapy (NPWT) system is shown. The dressing is structured to engage the NPWT system with a patient's skin or other tissue and to provide a substantially airtight seal in an area surrounding the wound. According to an illustrative embodiment, the dressing is a multi-layer dressing that includes a patient interface layer that is structured to bond to the tissue surrounding the wound area, and an upper cover that is applied over the patient interface layer to substantially cover the wound. The dressing also includes an absorbent material, positioned within the upper cover, to absorb any wound exudate through an opening in the patient interface layer.
According to an illustrative embodiment, the dressing includes a reclosure system that is structured such that portions of the dressing can be pulled away from the wound site and then reattached without the application of adhesive or other bonding agents to reestablish negative pressure across the wound. In at least one embodiment, the reclosure system includes a touch fastener disposed between the patient interface layer and the upper cover. The touch fastener includes a mechanical interlock that is connected by pressing together fastener strips that are bonded to the patient interface layer and the upper cover. To remove the upper cover from the patient interface layer, a user may simply peel back the upper cover to detach the interlocking fastener strips, which may be reused multiple times without sacrificing the integrity of the seal between the patient interface layer and the upper cover. Among other benefits, the dressing and reclosure system of the present disclosure facilitates access by clinician or other user to the wound site, and allows the clinician to inspect the wound site without having to replace the dressing materials.
In some embodiments, the touch fastener combines a non-adhesive-based mechanical fastener with an adhesive material to facilitate removal and replacement of the dressing. For example, the fastener strips may each include a plurality of releasably interlocking stems (e.g., ridges, hooks, protrusions, etc.) disposed across the surface of the strips that when pressed together, form a mechanical connection between the adjacent strips. The fastener strips may also include a bonding material, such as a pressure-sensitive adhesive, disposed in between the stems (e.g., in valleys between the stems) to ensure a substantially airtight and liquid tight seal across the fastening strips.
The fastening strips may be positioned along a perimeter of an opening in the patient interface layer and may completely surround the opening, on all sides of the dressing between the patient interface layer and the upper cover. In other embodiments, the fastening strips may be placed along only the longer sides of the dressing, and a silicone or thick gel adhesive may be used along the shorter sides, between adjacent fastening strips, to complete the connection between the two layers. Using gel adhesive in combination with the fastening strips reduces the force required to remove the upper cover, without significantly reducing the strength and reliability of the connection between the upper cover and patient interface layer. These and other features and advantages of the dressing and reclosure system are described in detail below.
According to an illustrative embodiment, the dressing 100 is used with and/or is part of an NPWT system 12. As shown in
As shown in
As shown in
The patient interface layer 106 is configured to engage with a patient's skin or tissue in the area surrounding the wound and to form a substantially airtight seal between the wound site 10 and the external environment. As shown in
In some embodiments, the patient interface layer 106 may be substantially the same shape and have the same area as the upper cover 104. As shown in
The upper cover 104 (e.g., top cover, etc.) substantially encloses the area above the wound site 10 and provides a fluid connection between the NPWT system (e.g., vacuum pump) and the wound site 10. As shown in
As shown in
In some embodiments, the absorbent material 122 may be formed from or otherwise include a superabsorbent polymer in the form of granules. The superabsorbent polymer may include Luquasorb 1160 or 1161, such as may be commercially available from BASF. The granules may be contained in a water-soluble carrier polymer. One example of the water-soluble carrier polymer is polyvinylpyrrolidone (PVP). The superabsorbent polymer and the water-soluble polymer may be formed into a slurry or a suspension using an organic solvent. The organic solvent may include propanone or propanol and may aid in delivery of the absorbent material 122 to the drape 120 or another carrier (e.g., an absorbent foam manifold disposed within the recessed area 124). In some embodiments, to increase the softness of the superabsorbent granules, a plasticizer may be added to the slurry. In one embodiment, the plasticizer may be water. In some embodiments, the slurry to form the absorbent material 122 may have a formulation of 20 parts by mass of PVP, 10 parts by mass of a superabsorbent polymer, 1 part by mass of glycerol, and 100 parts by mass of propanone. In some embodiments, to plasticize the granules, 1 part to 2 parts by mass of water may be added to the slurry mixture. In other embodiments, a water-soluble polymer superabsorbent precursor, such as acrylic acid or 2-acrylamido-2-methyl-propanesulfonic acid (AMPS), with suitable UV curing additives, may replace the superabsorbent polymer. Such a precursor may be a relatively low viscosity solution and can be printed onto at least one of the drape 120 or a separate carrier and exposed to UV light to form a soft gel, eliminating the need for a plasticizer. In some embodiments, the water-soluble polymer superabsorbent precursor may be similar to that used for preparing hydrogel coatings.
By way of example, the slurry mixture may be applied to the wound-facing side of the drape 120 to form an absorbent layer. In some embodiments, the slurry may be applied to the drape 120 through standard printing methods, such as silk screen printing, gravure printing, or by x-y plotter printing. The absorbent layer may be applied in a variety of different shapes such as circles, squares, hexagons, hoops/halos, stars, crosses, a range of lines, or any combination of shapes. The absorbent layer may be substantially evenly distributed on the drape 120 within the recessed area 124. In some embodiments, the absorbent material 122 may include a flexible plasticized hydrophilic polymer matrix having a substantially continuous internal structure. In some embodiments, the absorbent material 122 may include a combination of different materials.
The touch fastener 107 is disposed between the patient interface layer 106 and the upper cover 104 and is configured to detachably couple the patient interface layer 106 to the upper cover 104. The touch fastener 107 is structured to form a substantially airtight and liquid tight seal between the patient interface layer 106 and the upper cover 104. In the embodiments of
As shown in
In at least one embodiment, first fastening layer 108 and the second fastening layer 110 each include a pair of fastening strips that extend along a longest dimension of the opening 118. For example, as shown in
The touch fastener 107 may be any type of selectively resealable and reclosable mechanical interlock that can provide a substantially airtight and liquid tight seal between the upper cover 104 and the patient interface layer 106. For example, the touch fastener 107 may be a Velcro-style hook and loop fastener that includes (i) a male fastening strip and (ii) a female fastening strip that is structured to couple to the male fastening strip in response to an applied pressure between the male fastening strip and the female fastening strip. For example, in the embodiment of
In some embodiments, the lower fastening strip 136 and/or upper fastening strip 134 include a hook portion (e.g., flange, ledge, etc.) coupled to an outer, free end of each stem 144. For example, as shown in
In at least one embodiment, the first fastening layer 108 and/or the second fastening layer 110 is a hybrid closure that includes both a non-adhesive-based mechanical fastener (e.g., stems 144) and an adhesive material interposed between adjacent mechanical fastener portions. As shown in
Among other benefits, the touch fastener 107 structure provides a resealable and reclosable connection between the patient interface layer 106 and the upper cover 104 (see
To apply the dressing 300 to a patient, a clinician or other user simply removes a backing layer from an outer surface of the patient interface layer 306 and applies the exposed surface of the patient interface layer 306 to the tissue. The negative pressure source may then be activated to reduce the pressure in the space above the wound site, in between the wound and the upper cover 304, which compresses the absorbent layer. As shown in
As shown in
Referring to
In operation 404, a first fastening layer is joined to the patient interface layer. Operation 404 may include providing the first fastening layer; for example, by providing a plurality of fastening strips, and applying an adhesive product to a backing of the fastening strips and/or to select areas of the patient interface layer (e.g., along a perimeter of the opening). Operation 404 may further include applying the fastening strips of the first fastening layer to the patient interface layer. In at least one embodiment, operation 404 includes applying fastening strips on each side of the opening.
In other embodiments, operation 404 includes applying the fastening strips along only a portion of the perimeter of the opening. For example, operation 404 may include positioning a first fastening strip of the first fastening layer along a direction that is substantially parallel to a longest dimension of the opening and adhering the first fastening strip to the patient interface layer on a first side of the opening. Operation 404 may further include adhering a second fastening strip to a second side of the opening opposite from the first side. Operation 404 may additionally include applying a gel adhesive to the patient interface layer to substantially fill a gap between the first fastening strip and the second fastening strip (e.g., between ends of the first fastening strip and the second fastening strip, such that the fastening strips and gel adhesive together circumscribe the opening).
In operation 406, an upper cover is provided that is sized to cover the opening. Operation 406 may include cutting a drape made from Tagaderm™ or another thin film layer to substantially match the size of the patient interface layer. Operation 406 may further include forming a recessed area into the drape using a press operation and/or a heat treating operation. Operation 406 may additionally include placing an absorbent material into the recessed area and/or adhering the absorbent material to the drape using an adhesive material. Operation 406 may also include incorporating a negative pressure coupling (e.g., track pad, etc.) into the drape.
In operation 408, a second fastening layer is joined to the upper cover. Operation 408 may include providing the second fastening layer; for example, by providing a plurality of fastening strips, and applying an adhesive product to a backing of the fastening strips and/or to select areas of the drape that are aligned with the first fastening layer. Operation 408 may further include applying (e.g., adhering) the fastening strips of the second fastening layer to the drape.
In operation 410, the upper cover is coupled to the patient interface layer to form a substantially airtight seal between the upper cover and the patient interface layer. Operation 410 may include aligning the first fastening layer with the second fastening layer and pressing (e.g., via a press or another suitable fixture or process) a male interlocking member of the second fastening layer into a female interlocking member of the first fastening layer (e.g., by engaging the stems, rails, or other mechanical interlock between adjacent fastening strips). In other embodiments, the method 400 may include additional, fewer, and/or different operations.
The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps can be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions can be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.
This application claims the benefit of priority to U.S. Provisional Application No. 63/185,061, filed on May 6, 2021, which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2022/054108 | 5/4/2022 | WO |
Number | Date | Country | |
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63185061 | May 2021 | US |