Post-Operative Hybrid Dressing To Optimize Skin-Grafting Procedures In Reconstructive Surgery
20200261276 ยท 2020-08-20
Inventors
Cpc classification
A61M1/90
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
A61F13/00063
HUMAN NECESSITIES
A61M1/962
HUMAN NECESSITIES
A61B2017/00761
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
A device and associated method for treating a skin graft donor site includes a sheet having dimensions to cover the skin graft donor site and an area of skin surrounding the skin graft donor site. An adhesive is provided that has properties of adhering to the skin and the sheet in a manner that forms a liquid impermeable boundary surrounding the skin graft donor site. A port is integrated with the sheet that enables a suction force to be applied therethrough to produce a negative pressure between the sheet and skin graft donor site to manage fluid produced by the skin graft donor site.
Claims
1. A device for treating a skin graft donor site, the device comprising: a sheet having dimensions to cover the skin graft donor site and an area of skin surrounding the skin graft donor site; an adhesive having properties of adhering to the skin and the sheet in a manner that forms a liquid impermeable boundary surrounding the skin graft donor site; and a port integrated with the sheet that enables a suction force to be applied therethrough to produce a negative pressure between the sheet and skin graft donor site to manage fluid produced by the skin graft donor site.
2. The device of claim 1, further comprising filaments at the sheet and configured in the form of channels for fluid to pass therethrough from the skin graft donor site to the port.
3. The device of claim 2, wherein the filaments are embedded in the sheet.
4. The device of claim 1, wherein the port includes multiple ports.
5. The device of claim 4, wherein the multiple ports have a higher density in the sheet toward the boundary than toward a center of the skin graft donor site.
6. The device of claim 1, further comprising a reservoir in fluid communication with the port.
7. The device of claim 6, further comprising a bulb defining the reservoir and being configured to provide a negative pressure to apply the suction force through the port.
8. The device of claim 6, wherein the reservoir is integrated into the sheet and positionable apart from the skin graft donor site.
9. The device of claim 6, further comprising a reservoir base sheet, configured to be fixedly coupled to skin apart from the skin surrounding the skin graft donor site, and a reservoir top sheet configured to be detachably coupled to the reservoir base sheet, the reservoir being defined between the reservoir base sheet and the reservoir top sheet in at least one location the reservoir top sheet is not coupled to the reservoir base sheet.
10. The device of claim 9, wherein the reservoir top sheet is formed from a vapor transmissible film.
11. The device of claim 6, further comprising filaments between the port and the reservoir.
12. The device of claim 1, further comprising bio-resorbable material configured to be positioned over the skin graft donor site and under the sheet.
13. The device of claim 1, further comprising a structure to prevent clogging at the port.
14. The device of claim 1, wherein the sheet includes a material selected from a group of materials consisting of: a polyurethane, an organic polymer, a hydrogel.
15. The device of claim 1, further comprising biomaterials with integrated growth factors to enhance epidermal healing coupled to the sheet.
16. The device of claim 1, wherein the port is sized to pass up to 100 ml of fluid per day.
17. The device of claim 1, wherein the negative pressure is less than 100 mm Hg.
18. The device of claim 1, wherein the adhesive is on the sheet other than over a portion of the sheet expected to cover the skin graft donor site.
19. The device of claim 1, wherein the adhesive is provided on a backing sheet and is configured to release from the backing sheet following contact of the adhesive to the skin surrounding the skin graft donor site.
20. The device of claim 1, wherein the sheet includes transparent material to allow visualization of the donor site without removal of the sheet.
21. The device of claim 1, wherein the sheet includes a drug or molecule embedded in the sheet for delivery to the skin graft donor site.
22. The device of claim 1, further comprising a removable drain device in fluid communication with the port to drain fluid from the skin graft donor site.
23. A method for treating a skin graft donor site, the method comprising: adhesively coupling a sheet to an area of skin surrounding a skin graft donor site to form a liquid impermeable boundary; and applying a suction force through a port integrated with the sheet to produce a negative pressure between the sheet and skin graft donor site to manage fluid produced by the skin graft donor site.
24. The method of claim 23, further comprising delivering a drug or molecule to the skin graft donor site, wherein the drug or molecule is embedded in the sheet or delivered through the port.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments.
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DETAILED DESCRIPTION OF THE INVENTION
[0051] A description of example embodiments follows.
[0052] The invention generally provides an enhanced wound treatment dressing for skin grafts, targeting the skin graft donor site. Described are embodiments of a dressing device based upon wound healing principles from the inventors' cumulative clinical experience after many years of patient care as well as the inventors' expertise with bioengineered materials. Preliminary evidence has shown that there is no ideal way of addressing the donor site. Moreover, there are several well-known principles that should be considered for ideal wound healing of skin grafts donor sites.
[0053] Donor site healing principles:
[0054] Principle 1: Moisture is needed. Wounds produce exudate that contains growth factors known to stimulate wound healing. Wounds also heal faster in a moist environment through promoting keratinocyte migration and re-epithelialization.
[0055] Principle 2: The donor site is an acute wound. It produces a high amount of fluid exudate and moderate bleeding, which, in accumulation, generates an infection-prone environment.
[0056] Principle 3: Current management involves non-absorbent or absorbent dressings. Non-absorbent dressings accumulate a high amount of exudate. This exudate soon leaks through the dressing site, causing high levels of patient discomfort and requiring constant dressing changes and nursing interventions.
[0057] Principle 4: If absorbent dressings are used, they become saturated quickly and require multiple changes. These dressing changes are very painful and require sterile technique and trained personnel.
[0058] Principle 5: If left open to air, the wound dries out, hampering re-epithelialization and being exposed to pathogens and shearing damage.
[0059] An ideal dressing should share characteristics of both dry and moist dressings. The dressing should not only address the exudate problem but expedite painless healing of the donor site by maintaining a moist and sterile environment. In some embodiments, a hybrid dressing is provided that combines features from both types of dressings. This novel concept reduces discomfort, nursing interventions, pain, frequency of dressing changes, and promote adequate epithelialization. This will overall reduce complications and improve patient experience.
[0060] Embodiments of the present invention address the problem of managing fluid, e.g., exudate, which is produced by a surface wound, such as a split thickness skin graft donor site. Other approaches have addressed drainage of a cavity wound, such as surgical wounds from abdominal surgery. For example, a surgical drain device that includes an adhesion matrix of biodegradable polymer material and drain tubes attached to the matrix is described in International Application Number PCT/US2012/033608, filed Apr. 13, 2012 and entitled Surgical Cavity Draining And Closure System, which published as WO 2012/142473 A1 on Oct. 18, 2012.
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[0063] As shown in
[0064] For example, the sheet 102 can include a material selected from a group of materials consisting of: a polyurethane, an organic polymer, a hydrogel.
[0065] As illustrated in
[0066]
[0067]
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[0069] As described above with reference to
[0070] As illustrated in
[0071] As illustrated in
[0072]
[0073] Any sheet of the device, such as the reservoir top sheet, can be formed from a vapor transmissible film, which can help in managing the fluid through evaporation between more active removal of fluid by a medical care practitioner or the patient, but also allows for gaseous exchange for purposes described below in reference to
[0074] As exemplified by device 600 illustrated in
[0075] Embodiments of the device can further include filaments between the port and the reservoir, similar to the filaments illustrated in
[0076]
[0077] In some embodiments, the device can further include biomaterials with integrated growth factors to enhance epidermal healing coupled to the sheet 102.
[0078] The sheet 102 can include a drug or molecule embedded in the sheet for delivery to the skin graft donor site. A drug or a molecule can also be delivered to the skin graft donor site through the port 106.
[0079] In some embodiments, the device 700 can further include a structure 426 to prevent clogging at the port. For example, a sieve-like structure or a membrane can be positioned at the port. Preventing clogging can be particular useful when the device includes a biodegradable material or a hydrogel, which tend to break down and mix with the fluid from the donor site. The device can further include a removable drain device in fluid communication with the port to drain fluid from the skin graft donor site.
[0080]
[0081] As illustrated in
[0082] In one embodiment, the invention includes a hybrid dressing device 900 that includes an occlusive PEG-diacrylate (PEGDA) dressing 902 with adhesive 904 around the edges. PEG is a cytocompatible material, non-adhesive, hydrophilic that allows gas and oxygen exchange, containing fluid exudate under the dressing in order to maintain moisture. PEGDA is a synthetic polymer that can be conveniently crosslinked upon exposure to ultraviolet (UV) light to generate flexible hydrogels. PEG-based hydrogels are highly tunable and biocompatible materials. PEGDA forms a soft and clear hydrogel, which is useful as a dressing material. It is a biologically inert and non-immunogenic substance. This hydrogel will have fluid drainage system in order to address the excess exudate from the donor site.
[0083] A previously published report has shown that a PEG and dl-lactic acid-co-glycolic acid (PLGA)-based hydrogel improved keratinocyte migration (Reference: Lee P Y, Cobain E, Huard J, Huang L., Mol Ther. 2007; 15(6):1189-1194). These hydrogels also supported the growth and proliferation of keratinocytes and improved re-epithelialization.
[0084] The hydrogel-based dressing physically provides a barrier against external factors that can potentially cause additional infection. Due to their high water content, hydrogel dressings can prevent water loss which is a critical aspect required for wound healing. Hydrogels are porous materials; therefore, they allow for adequate gaseous exchange over the wound. Hydrogels contain bioactive functional groups to enable cell adhesion and proliferation. A requirement of complete epithelialization of the wound is proliferation of dermal fibroblasts. These cells will proliferate on the proposed hydrogel.
[0085] The hydrogel dressing can i) be low-cost, ii) be flexible, iii) be easy to apply and remove, iv) be biocompatible, v) be sterilized easily, vi) be molded or cut into desired size and shapes, vii) possess tunable physical, chemical, and biological properties, viii) provide a moist environment for the wound without damaging the tissue, ix) allow for gaseous exchange, x) provide a physical barrier against external factors, xi) provide cushioning effect to the wound, xii) provide a cooling effect upon application which might reduce inflammation and pain, and xiii) have the potential to enhance epithelialization, angiogenesis, and vascularization.
[0086] Moreover, the utility of the dressing is enhanced by a suction mechanism 920 (
[0087] The hybrid model keeps the interior environment intact, sterile free of excess fluid but moist. It requires minimal dressing changes and very low maintenance. It is lightweight and comfortable, which allows the patient to mobilize in the early post-operative period. The suction mechanism avoids the uncomfortable leakage around the dressing and the need for dressing exchange. This, in turn, minimizes nursing interventions, the risk of infection from manipulating the dressing, and patient pain.
[0088] In an embodiment that provides a transparent material as part of the sheet or of the entirety of the sheet, the transparent material allows medical practitioners and the patient to have visibility of and monitor closely both graft and donor site dressing. Due to the materials, the dressing is longer-lasting and inexpensive and meets all the principles listed above. Similarly, the moist environment of the volume between the sheet and skin graft donor site promotes keratinocyte migration.
[0089] In various embodiments, the invention also includes at least one of the following: [0090] a) addition of growth factors to the hydrogel as well as trace elements for enhancing wound healing; [0091] b) addition of any tissue engineered scaffold, natural or synthetic; [0092] c) incorporation of a manual or electronic portable pump; [0093] d) connection to either commercial suction pumps or hospital wall suction; [0094] e) connection to manual mechanism such as syringes; [0095] f) employment of sensor in the hydrogel for markers of apoptosis and necrotic tissue; [0096] g) inclusion of dissolvable molecules of oxygen in the hydrogel; medications such as local anesthetics or promoters of wound healing [0097] h) addition of Stem cells or mesenchymal cells embedded in the hydrogel; and [0098] i) addition of cultured fibroblasts or keratinocytes in the hydrogel.
[0099] Other suitable applications of example embodiments of the invention include, for example, treatment of:
[0100] a) different types of fistulas (e.g., gastrointestinal, soft tissue, and urological);
[0101] b) highly exudative wounds, acute or chronic; and
[0102] c) burns.
[0103] In view of the foregoing descriptions of
[0104] 1. Embodiment 1 is a dressing for wound healing, comprising: [0105] a) a hydrogel sheet, the hydrogel sheet defining channels and an opening, wherein the channels are in fluid communication with the opening; [0106] b) a vacuum fitting in fluid communication with the opening, whereby the channels of the hydrogel sheet are in fluid communication with the vacuum fitting; and [0107] c) an adherent at the hydrogel sheet, whereby the hydrogel sheet can be affixed to skin surrounding a wound, thereby causing the channels to be in fluid communication with the wound. In a specific embodiment, the channels may be in contact with the wound.
[0108] 2. The dressing of embodiment 1, further including a vacuum source in fluid communication with the vacuum fitting.
[0109] 3. The dressing of embodiment 1, further including at least one growth factor in the hydrogel sheet.
[0110] 4. The dressing of embodiment 1, further including at least one wound-healing component in the hydrogel sheet such as cells, fragments of cells, growth factors, medications.
[0111] 5. The dressing of embodiment 1, further including at least one natural or synthetic tissue-engineered scaffold at the hydrogel sheet.
[0112] 6. The dressing of embodiment 1, further including means for connecting the vacuum fitting to a manual or portable suction pump, or a hospital wall suction port.
[0113] 7. The dressing of embodiment 1, further including a fitting at the hydrogel sheet for injection of a fluid to the wound site such as medications, anesthetics or wound healing promoters.
[0114] 8. Embodiment 8 is the dressing of embodiment 1, further including at the hydrogel sheet at least one sensor.
[0115] 9. The dressing of embodiment 8, wherein the at least one sensor is selected from the group consisting of a marker for apoptosis, and a marker for necrotic tissue.
[0116] 10. The dressing of embodiment 1, wherein the hydrogel sheet includes dissolved oxygen.
[0117] 11. The dressing of embodiment 1, wherein the hydrogel sheet includes at least one of stem cells and mesenchymal cells.
[0118] 12. The dressing of embodiment 1, wherein the hydrogel sheet includes at least one of cultured fibroblasts and keratinocytes.
[0119] 13. Embodiment 13 is a method for treating a wound comprising the steps of: [0120] a) adhering a hydrogel sheet to a wound site, the hydrogel sheet defining channels and an opening, wherein the channels are in fluid communication with the opening; and [0121] b) applying intermittent vacuum through a fitting at the opening, whereby exudate is drawn from the wound, thereby treating the wound.
[0122] 14. Embodiment 14 is the method of embodiment 13, wherein the wound is at least one member of the group consisting of: a skin graft recipient site; a skin graft donor site; a trauma site; a burn site; a surgical site; a fistula; an acute wound site; and a chronic wound site.
[0123] 15. Embodiment 15 is the method of embodiment 14, wherein the wound is a fistula.
[0124] 16. The method of embodiment 15, wherein the fistula is at at least one member of the group consisting of: gastrointestinal site; soft tissue site; and a urological site.
[0125] The relevant teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.
[0126] While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended s.