WO2024040210A1 - Integrated wound dressing and application component for dermal wounds, ulcers, and burns - Google Patents

Abstract

Disclosed herein is a wound treatment device integrating a wound dressing and an application component which secures the wound dressing to a body part. The wound treatment device is a complete system for wound care eliminating adhesives in most embodiments and reducing dressing bulk which either may cause unintended injury. The device can be applied by an unskilled patient or assistant at home rather than an expensive nurse in a medical facility. The device reduces the cost of wound care, eliminates Medical Adhesive Related Skin Injury and adds little bulk lessening the risk of complications.

Description

INTEGRATED WOUND DRESSING AND APPLICATION COMPONENT FOR DERMAL WOUNDS, ULCERS, AND BURNS

Inventors: Darryl J. Werner and Gregory F. Brooks

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional patent application number 63/372,000 filed August 19, 2022; which is incorporated by reference herein in its entirety.

FIELD

This disclosure relates to a medical device ("wound treatment device") that combines a wound healing dressing and an application component which secures the wound dressing to a body part.

BACKGROUND

Dermal wounds present an undue burden on the resources of health care systems. A 2018 retrospective analysis of Medicare beneficiaries identified that ~8.2 million people had wounds with or without infections. Medicare cost estimates for acute and chronic wound treatments ranged from $28.1 billion to $96.8 billion. (Human Wounds and Its Burden: An Updated Compendium of Estimates Advances in Wound Care FEB 2019.) Current therapy requires the application of a dressing to protect the wound from contamination, maintain proper moisture balance, reduce bacterial contamination and infection, absorb wound discharge, or facilitate healing by other means. Other therapeutic modalities may be used concurrently. Current wound dressing products are limited by 3 concerns: First: Most instances require a skilled person, most commonly a nurse, to apply the wound dressing usually daily in a wound clinic, hospital, skilled nursing facility, or in a patient's home, creating additional cost. Most patients are unable to change their wound dressings independently. Second: Tape and other adhesive used to hold wound dressings in place can injure periwound skin resulting in a complication known as "MARSI"- Medical Adhesive Related Skin Injury. (Medical adhesive - related skin injury - Br J Nurs.) Third: wound dressings add bulk which may exaggerate or create pressure points preventing healing, causing wounds to worsen, or create new wounds. (Dressing-related trauma: clinical sequelae and resource utilization in a UK setting. Clinicoecon Outsomes Res June 2014; Prevention of medical adhesive-related skin injury during patient care: A scoping review - International Journal of Nursing Studies Advances Dec 2022; Complications associated with postoperative dressings: a clinician's perspective. - Wound practice and research 2019.) The novel medical device described herein addresses these 3 limitations of current wound dressing application products and procedures thereby reducing cost and complications.

SUMMARY

The device described herein is a unique solution to problems in caring for dermal wounds. This device may be applied by the patient or an unskilled assistant, does not require tape to secure the dressing, and adds little bulk.

Disclosed herein is a dermal wound treatment device integrating a wound dressing and an application component. It is a complete wound care system that is easy to apply, does not rely on tape to secure, and does not add significant bulk.

Some embodiments include a method of treating wounds comprising applying the wound treatment device of any preceding claim to a subject. In some embodiments, the application component and wound dressing is applied to a dermal wound occurring on a body part of that subject.

Some embodiments include a kit, comprising a 30-day supply of the wound treatment device described herein, wherein the kit comprises 30 pairs of daily sterile disposable wound treatment devices for bilateral foot, hand, arm, or leg ulcers.

Some embodiments include a kit, comprising a 14-day supply of the wound treatment device described herein, wherein the kit comprises 14 pairs of daily sterile disposable wound treatment devices for bilateral foot, hand, arm, or leg ulcers.

Some embodiments include a kit, comprising a 7-day supply of the wound treatment device described herein, wherein the kit comprises 7 pairs of daily sterile disposable wound treatment devices for bilateral foot, hand, arm, or leg ulcers.

Some embodiments include a kit, comprising a 30-day supply of the wound treatment device described herein, wherein the kit comprises 30 daily sterile disposable wound treatment devices for an ulcer on eitherthe left or right foot, hand, arm, leg, torso, head, neck or genital region.

Some embodiments include a kit, comprising a 14-day supply of the wound treatment device described herein, wherein the kit comprises 30 daily sterile disposable wound treatment devices for an ulcer on either the left or right foot, hand, arm, or leg, torso, head, neck, or genital region.

Some embodiments include a kit, comprising a 7-day supply of the wound treatment device described herein, wherein the kit comprises 30 daily sterile disposable wound treatment devices for an ulcer on either the left or right foot hand, arm, or leg, torso, head, neck or genital region.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 depicts an example of an embodiment of the integrated wound treatment device described herein applied to a foot.

FIG, 2 depicts an example of an embodiment of an integrated wound treatment device described herein which incorporates an electrically conductive component intended to stimulate wound healing

FIG. 3 depicts an example of an embodiment of an integrated wound treatment device described herein which incorporates a security component to prevent removal by an uncooperative subject

FIG. 4A depicts an example of an embodiment of an integrated wound treatment device described herein which incorporates an arch support feature.

FIG. 4B depicts an example of an embodiment of an integrated wound treatment device described herein which incorporates a pressure redistributing accessory. DETAILED DESCRIPTION

This disclosure relates to a medical device for treating acute and chronic wounds on any body part which integrates a wound healing dressing and an application component.

A dermal wound, ulcer, or burn includes a partial or full thickness loss of skin structure or integrity (From herein, the terms "wound", "ulcer", and "burn" are referred to collectively as "wound"). A wound may be caused by external trauma, surgical penetration, flame or heat, chemicals, pressure, intrinsic skin failure, circulatory insufficiency, or other causes. Individuals with diabetes are especially prone to wounds occurring on their feet. Acute wounds which fail to heal as expected become "chronic" and may lead to extremity amputation, additional morbidity, and in some instances death.

The wound dressing is the part of the device that comes into direct contact with the wound, and the application component is the part of the device that is affixed to the wound dressing and is in contact with skin around the wound to secure the wound dressing in place so that the wound dressing may stay in contact with the wound. The wound treatment device in its entirety is applied to a wound and anatomic structures extending above, below, and circumferential to the wound, e.g., within about 4 cm, within about 10 cm, within about 20 cm, or within about 30 cm of the wound, and potentially more remote anatomical structures.

The application component comprises, or is composed of, a thin flexible material, such as a textile or fabric, which conforms to and covers a body part (e.g., by the shape of the application component and/or by stretching of the application component material), such as a human or animal body part. The wound dressing is integrated within the application component so that the application component holds the wound dressing to a wound to a body part. For illustration purposes, FIG. 1 shows how application component 10 can conform to a foot and hold wound dressing 20 into place on a wound on the bottom of a foot.

The application component can be adapted to apply the wound dressing to any part of a foot (including toes, dorsum or sole of the foot, metatarsals, heel, calcaneal, ankle or other), and can be adapted to conform to and cover any body part in a similar manner, such as, in addition to a foot, upper leg, a lower leg, an upper and lower leg, a knee, a thigh, a pelvis, pelvis hips and genitals, an abdomen, a chest (thorax), a back, an upper arm, a lower arm, an upper and lower arm, an elbow, a shoulder, a neck, a scalp, a face, an ear, etc.

In some embodiments, the application component and/or the wound dressing is nonadhesive, meaning that the application component does not stay in place on the body, partially or completely, by adhesion, such as by use of an adhesive substance, such as a glue or adhesive present in, e.g., a medical tape.

In some embodiments, the application component and/or the wound dressing is a skin safe adhesive, meaning that the application component and/or the wound dressing stays in place on the body, partially or completely, by adhesion by use of an adhesive substance, such as a glue or other adhesive; for example, "Safetac" (available from Molnycke).

In some embodiments, the wound treatment device is applied to a wound on a foot, and the application component is cylindrical an conforms anatomically to a foot and an ankle. The application component may have a terminal portion, such as a portion covering the end of a foot or toes. This terminal portion may be closed, as shown in FIG. 1, or may be open, so that one or more toes or other front portions of the foot may be uncovered. Additionally, for a wound treatment device that is applied to a wound on a foot, either closed as shown in FIG. 1, or open, the application component may extend up to ankle height, to above the calf, to below the knee, to above the knee, all the way up the leg to include the thigh, or to some point between any of these positions.

The application component comprises, or is composed of, a thin flexible material, such as a textile or fabric. Any suitable material, textile, or fabric may be used, including, for example, cotton, polyester, elastic, wool, nylon, acrylic, olefin, silk, cashmere, mohair, linen, or a combination thereof. The application component may only apply sufficient force to keep the wound treatment device in place on the body part over the wound. Alternatively, the application component itself or the entire device may apply more compression force than needed to simply keep the wound dressing in place, e.g., in a range of compression from 1 mmHg to 60 mmHg or greater, about 10-20 mm Hg, about 20-30 mm Hg, about 30-40 mm Hg, about 20-40 mmHg, about 40-50 mm Hg, about 40-60 mmHg, or more, so that the compression reduces edema associated with the wound.

In some embodiments, the application component comprises cotton.

In some embodiments, the application component comprises polyester.

In some embodiments, the application component comprises elastic.

In some embodiments, the application component comprises wool.

In some embodiments, the application component comprises nylon.

In some embodiments, the application component comprises acrylic.

In some embodiments, the application component comprises olefin.

In some embodiments, the application component comprises silk.

In some embodiments, the application component comprises cashmere.

In some embodiments, the application component comprises mohair.

In some embodiments, the application component comprises linen.

The application component may incorporate, be woven with, or be impregnated with, additional ingredients or components for treating periwound conditions, such as dermatitis or cellulitis with a medication to treat these or other conditions, e.g. an antimicrobial (e.g. silver, silver sulfadiazine, copper, etc.), an antibiotic (such as metronidazole), or an antifungal (e.g. clotrimazole, miconazole, or nystatin), a steroid, or other medication or pharmacologic compound.

The application component is integrated with the wound dressing so that the application component holds the wound dressing to a wound on a body part. For example, the application component may be sewn, stitched, glued, or otherwise affixed to the wound dressing. The wound dressing may be, for example, a patch that fills a hole in the fabric of the application component, such as in the device depicted in FIG. 1. Alternatively, instead of filling a hole in the application component, the wound dressing may be a layer that is beneath and/or above the application component. The hole or patch configuration may have the advantage of reducing the bulk of the wound treatment device so that it can fit more comfortable, e.g., inside a shoe or other clothing.

The wound dressing may comprise, or be composed of, any suitable material, such as an alginate, silver alginate, a synthetic alginate type dressing, adhesive or non-adhesive foam, hydrocolloid, gauze, transparent or non-transparent film, a composite dressing, a matrix wound dressing, collagen wound dressing, a super absorbent type (e.g. a polyacrylic acid salt) dressing, or a combination thereof.

In some embodiments, the wound dressing comprises an alginate.

In some embodiments, the wound dressing comprises silver alginate.

In some embodiments, the wound dressing comprises an adhesive foam.

In some embodiments, the wound dressing comprises a non-adhesive foam.

In some embodiments, the wound dressing comprises a hydrocolloid.

In some embodiments, the wound dressing comprises a gauze.

In some embodiments, the wound dressing comprises transparent or non-transparent film.

In some embodiments, the wound dressing comprises a composite dressing.

In some embodiments, the wound dressing comprises a matrix wound dressing.

In some embodiments, the wound dressing comprises collagen wound dressing.

In some embodiments, the wound dressing comprises a super absorbent type dressing. In some embodiments, the application component and the wound dressing are made of different materials.

In some embodiments, the application component's material may contain silver as an antimicrobial.

In some embodiments, the application component's material may contain an antifungal medication.

In some embodiments, the application component's material may contain a steroid medication.

In some embodiments, the application component's material may contain silver sulfadiazine.

The wound dressing may incorporate, or be impregnated with, additional ingredients or components to treating a wound, such as an indicator, a medication to improve wound healing, e.g. an antimicrobial (e.g. silver), an antibiotic (such as metronidazole or gentamycin), an antifungal (e.g. clotrimazole, miconazole, or nystatin), a steroid, a growth factor, a debriding medication or agent, a kinase inhibitor (e.g. nintedanib) to reduce or improve scarring, etc.

In some embodiments, the wound dressing may contain silver as an antimicrobial.

In some embodiments, the wound dressing may contain an antifungal medication.

In some embodiments, the wound dressing may contain a steroid medication.

In some embodiments, the wound dressing may contain silver sulfadiazine.

In some embodiments, the wound dressing may be impregnated with an antibiotic medication.

In some embodiments, the wound dressing may be impregnated with the antibiotic metronidazole or gentamycin. In some embodiments, the wound dressing may be impregnated with an antibiotic that is not metronidazole or gentamycin.

In some embodiments, the wound dressing may be impregnated with an antifungal medication.

In some embodiments, the wound dressing may be impregnated with an antifungal medication such as: clotrimazole, miconazole, or nystatin.

In some embodiments, the wound dressing may be impregnated with an antifungal medication that is not clotrimazole, miconazole, or nystatin.

In some embodiments, the wound dressing may be impregnated with a steroid medication.

In some embodiments, the wound dressing may be impregnated with a growth factor.

In some embodiments, the wound dressing may be impregnated with a debriding medication or agent.

In some embodiments, the wound dressing may be impregnated with a kinase inhibitor to reduce or improve scarring.

In some embodiments, the kinase inhibitor comprises nintedanib.

In some embodiments, the wound dressing and the application component are two different materials and/or two different pieces. In some embodiments, the wound dressing and the application component are a single piece and/or a single material.

The wound dressing described herein is useful in treating wounds in humans and animals, including diabetic ulcers, burns, wounds caused by external trauma, surgical penetration, wounds caused by flame or heat, chemicals, pressure, wounds caused by intrinsic skin failure and circulatory insufficiencies, or other causes.

In some embodiments, the entire wound treatment device, including both the application component and the wound dressing, is sterile or sterilized. In some embodiments, the wound treatment device is single use and/or disposable.

In some embodiments, embodiments, the wound treatment device is sterile, and each wound treatment device Is individually wrapped.

In some embodiments, the wound treatment device includes an application component that is reusable and a new wound dressing attached for each use.

In some embodiments, an electric current or voltage may be conducted through the wound treatment device to facilitate wound healing. Electrical stimulation has been shown to accelerate wound healing and increase cutaneous perfusion in human studies. (Electrical

Stimulation to Accelerate Wound Healing - DDiiaabbeett FFoooott Ankle. 2013; 4:

10.3402/dfa.v4K).22081.) Thus, the wound treatment device may contain an electrically conductive component which is located In the wound treatment device to allow electric current through a portion of the device In contact with the wound and/or periwound skin or the entire area covered by the device. The electrically conductive component may comprise the entire device or a portion of the device intended to target a specific area. The electrically conductive component may contain an electrically conductive material, such as a conductive metal, e.g., copper, silver, gold, aluminum, zinc, nickel, etc., which may be woven into the textile or fabric of the device, run through the wound treatment device as metal wires, or may be coated on, impregnated with, or absorbed into the material. A silver coating, may function as both an antimicrobial and a conductive coating. The wound treatment device may also contain a power source, such as a battery, to create the current or voltage. For example, FIG.

2 depicts an example of an embodiment of a wound treatment device which incorporates electrically conductive component 30 intended to stimulate wound healing.

In some embodiments, the wound treatment device may incorporate a security component to secure it to a patient and prevent removal by an uncooperative patient. This feature may incorporate Velcro and or nylon webbing roll plus a clip. For example, FIG. 3 depicts an example of an embodiment of a wound treatment device which incorporates security component 40 to prevent removal by an uncooperative subject. In the example depicted In FIG. 3, security component 40 comprises a Velcro strap with a plastic clip that is applied circumferentially around the ankle to make it more difficult for an uncooperative person to remove. In some embodiments, the wound treatment device may incorporate a pressure relief component that facilitates pressure relief or redistribution, or prevents shear or chafing. This feature may incorporate various shaped foams, an air pillow, a foot arch support, or other pressure relieving or redistributing or soft material that inserts into a pocket on the device. The pressure relief component may be affixed to the device with a temporary attachment feature, such as Velcro, or may be permanently affixed to the device. In some embodiments, the pressure relief component comprises an arch support. For example, FIG. 4A depicts an example of an embodiment of the wound treatment device which Incorporates arch support feature 50, and FIG. 4B depicts an example which Incorporates pressure redistributing accessory 60. The arch and pressure relief pieces may be sewn or glued In place, attached with Velcro, or Inserted Into a pocket on the device.

In some embodiments, the entire application vehicle may be constructed of a material that also serves as the wound dressing. Examples of suitable materials for this purpose include alginate material, silver alginate material, an adhesive or non-adhesive foam material, hydrocolloid, gauze, transparent or non-transparent film, a composite dressing, a matrix wound dressing, collagen wound dressing, or a super absorbent type dressing material.

The wound treatment device may also be designed to Include a microneedle medication delivery system. For example, a microneedle medication delivery system may comprise: one or a plurality of coated microneedles embedded Into the device which Includes a layer of treatment product placed on each individual microneedle, enabling medicines to be applied Into the skin and or the wound area In a single step; one or a plurality of dissolvable microneedles embedded into the device as a single component product, where the microneedle structure contains the treatment within a matrix that, on application, dissolves into the skin and the area around the wound; a two-part system embedded Into the device with solid microneedles and a separate topical medication; or a combination thereof. The microneedle delivery system may be, for example, in the form of a patch that is applied to the skin, creating channels that allow a separately applied topical to have an accelerated wound healing effect.

The wound treatment device may also be designed to deliver a gene therapy medication (such as a non-invasive, topical, re-dose-able gene therapy medication) directly to an area for treatment of dystrophic epidermolysis bullosa (DEB) or other types of wounds, bums, or other skin conditions enabling production of normal proteins to address a fundamental chromosomal disease-causing mechanism. For example, a wound treatment device may deliver a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy Indicated for the treatment of wounds In patients with DEB.The wound treatment device may be part of a matching set, e.g., for two feet, two hands, two arms, or two legs.. In such a matching set, one of the two may contain the wound dressing (e.g., for use with the foot having the wound) and the other may be just the application component material (e.g., for use on the foot without a wound), or both may include the wound dressing (e.g., for use where both feet have a wound). In addition to the foot, for the treatment of wounds on other affected areas, a matching set may be used in place of, e.g., sleeves or gloves.

In some embodiments, the wound treatment device comes in a kit having, e.g., 7-14, 30-120, 30, 60, or 120 wound treatment devices, or pairs of wound treatment devices, for daily use. For example, 30 devices could be used daily on a single body part for 30 days, 60 devices could be used daily on a single body part for 60 days, 60 devices could be used for 30 days on bilateral body parts, or 120 devices could be used for 60 days on bilateral body parts.

The wound treatment devices described herein combine a wound healing dressing and an application component that secures the wound dressing to a patient's body part, such as a foot. This novel device Improves the treatment of dermal wounds by eliminating bulky dressings, avoiding tape Injury to adjacent skin, and allowing most patients to change their own dressing without the need for a home nursing or clinic visit.

The wound treatment devices described herein may be a medical device which incorporates a therapeutic wound dressing into a cylindrical component composed of a textile. This device is easy to apply by a patient or an untrained assistant and does not add bulk that could exaggerate a pressure point over the wound. Tape is not required to secure a dressing, so tape injury is avoided. The device reduces the cost of caring for patients by decreasing the need for dressing changes in expensive wound clinics or by costly home nurses. It improves adherence as It is easy to apply and does not interfere with the ability to wear a shoe. Any type of many existing dressing product may be incorporated Into this medical device. The cylindrical application component may provide compression or no-compression depending on the clinical indication. These medical devices are sterile, disposable, and changed daily or more/less frequently depending on wound condition and amount of wound drainage.

The wound treatment devices described herein are easy to apply by a patient or unskilled assistant thereby eliminating expensive hospital, medical clinic, office, or home nurse visits. They may also reduce dressing bulk and pressure points. The wound treatment devices described herein do not require tape to hold dressings In place, which may eliminate tape Injury to skin. The wound treatment device described herein may Incorporate dressing types that have proven efficacy.

The wound treatment device may enable patients to continue normal activities, such as to continue work or school, and to wear normal footwear.

The wound treatment device may position the wound dressing to specific areas of the foot Including the toes, dorsum or sole of the foot, metatarsals, heel, calcaneal, ankle or other. The wound treatment device may position the wound dressing to other specific body areas as needed Including hand, leg, arm, torso, neck, head, or genital regions.

Example 1

A 54-year-old male with type 2 diabetes suffers from a sub 1^st metatarsal ulcer for 6 months. Prior treatment includes daily dressing changes by a home nurse, periodic sharp debridement by his podiatrist, and an offloading heeling shoe. The clinician is concerned that the wound is failing to heal, there is tape irritation on the adjacent skin, and the patient's HMO is asking to discontinue expensive home nurse visits due to lack of progress. The podiatrist notes that dressings tend to slip out of place and bulky dressings may be adding pressure to the wound area when the patient ambulates. The podiatrist prescribes an Integrated Wound Dressing and Application Component with a dressing consisting of a silver alginate contact layer and foam sub layer that is impermeable on the outer side. There Is antifungal medication impregnated into the application component to prevent fungal dermatitis. The patient can change this dressing himself every day without assistance and dressing bulk is eliminated which reduces pressure on the wound. On week 2 of this new therapy, new granulation is noted. In 3 months, the wound is fully healed.

Example 2

An active 70-year-old female patient with type 2 diabetes suffers second degree sunburns to the dorsum of both feet while on vacation in Palm Springs 2 weeks prior to visiting her doctor. The patient is frustrated because the bulky dressings will not allow her to wear closed shoes and she must stay at home for several hours each day anticipating a home nurse's arrival to change her dressings. Her doctor orders an Integrated Wound Dressing and Application Component featuring a foam dressing. Silver threads are woven into the application component to reduce bacterial burden and help prevent a wound infection. Silver sulfadiazine Is Incorporated into the foam dressing. The patient Is pleased that she can wear her regular footwear and does not have to waste time waiting for a home nurse visit by changing the wound dressing herself daily. Her bums heal uneventfully In 2 weeks.

Example 3

An 84-year-old female who is bedridden and a nursing home resident develops a left heel ulcer. This patient has type 2 diabetes and peripheral arterial insufficiency. The hospital doctor evaluates her ulcer and orders an Integrated Wound Dressing Application Component to be applied and changed every day. This doctor also orders that the heel be elevated and not in contact with the bed. The doctor's choice of this device considers ease of application and daily dressing changes, prevention of tape Injury to the periwound skin, and low profile which decreases bulk. The nursing home Is pleased that this type of device can be changed by a nursing assistant rather than a more costly registered treatment nurse. This patient's ulcer slowly heals over 8 weeks.

Example 4

A 40-year-old female with lifelong type 1 diabetes develops a right 1^st toe ulcer. This patient works in the food industry and is the sole support of her family. She must be able to wear a shoe and continue to work while treating her toe ulcer. Her wound doctor orders a 30-day supply of Integrated Wound Dressing and Application Components for this patient and instructs this patient to change the device daily. The patient is able to continue working and her ulcer heals after 4 weeks.

Claims

N 1 CLAIMS

1. A wound treatment device comprising a wound dressing and an application component.

2. The wound treatment device of claim 1, wherein the application component is nonadhesive.

3. The wound treatment device of claim 1, wherein the application component is a skin safe adhesive.

4. The wound treatment device of any preceding claim, wherein the application component comprises a textile, wherein the textile comprises cotton, polyester, elastic, wool, nylon, acrylic, olefin, silk, cashmere, mohair, linen, or a combination thereof.

5. The wound treatment device of any preceding claim, wherein the application component is cylindrical and conforms anatomically to a body part.

6. The wound treatment device of claim 5, wherein the body part is a foot, a hand, an arm, a leg, a torso, a neck, a head, or a genital region.

7. The wound treatment device of any preceding claim, wherein the application component has a terminal portion that is open.

8. The wound treatment device of any preceding claim, wherein the application component has a terminal portion that is closed.

9. The wound treatment device of any preceding claim, wherein the application comprises a compression material.

10. The wound treatment device of any preceding claim, wherein the application component comprises a non-compression material.

11. The wound treatment device of any preceding claim, wherein the application component comprises silver as an antimicrobial.

12. The wound treatment device of any preceding claim, wherein the application component comprises an antifungal medication.

13. The wound treatment device of any preceding claim, wherein the application component contains a steroid medication.

14. The wound treatment device of any preceding claim, wherein the application component contains Silver Sulfadiazine. N

1

15. The wound treatment device of any preceding claim, wherein the wound dressing comprises an alginate, silver alginate, an adhesive or non-adhesive foam, hydrocolloid, gauze, transparent or non-transparent film, a composite dressing, a matrix wound dressing, collagen wound dressing, or a super absorbent type material.

16. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with an antibiotic medication.

17. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with metronidazole.

18. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with an antifungal medication.

19. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with clotrimazole.

20. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with a steroid medication.

21. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with a growth factor.

22. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with a debriding medication or agent.

23. The wound treatment device of any preceding claim, wherein the wound dressing is impregnated with a kinase inhibitor (Nintedanib) to reduce or improve scarring.

24. The wound treatment device of any preceding claim, wherein the device is sterile intended for a single use, and disposable.

25. The wound treatment device of any preceding claim, wherein the application component is reusable.

26. The wound treatment device of any preceding claim, wherein the device is for use on a foot, a hand, an arm, or a leg wound, and includes a matching piece for the other foot, the other hand, the other arm, or the other leg.

27. The wound treatment device of any preceding claim, further comprising an electrically conductive component intended to facilitate wound healing. N

1

28. The wound treatment device of claim 27, wherein the electrically conductive component allows an electric current to affect a portion of an area of a body that is in contact with the wound treatment device.

29. The wound treatment device of claim 27, wherein the electrically conductive component allows an electric current to affect the entire area of a body that is in contact with the wound treatment device.

30. The would treatment device of claim 27, further comprising a power source.

31. The wound treatment device of any preceding claim, further comprising a security component.

32. The wound treatment device of any preceding claim, further comprising a pressure relief component.

33. The method of claim 32, wherein the pressure relief component comprises a foot arch support.

34. The wound treatment device of any preceding claim, wherein the wound dressing and the application component are composed of the same material, and the material comprises an alginate, silver alginate, an adhesive or non-adhesive foam, hydrocolloid, gauze, transparent or non-transparent film, a composite dressing, a matrix wound dressing, collagen wound dressing, or a super absorbent type material.

35. The wound treatment device of any preceding claim, further comprising a microneedle medication delivery system.

36. The wound treatment device of any preceding claim, further comprising a gene therapy medication.

37. A method of treating wounds comprising applying a wound treatment device of any preceding claim to a subject.

38. The method of claim 37, wherein the subject is a human being.

39. The method of claim 37, wherein the subject is an animal.

40. The method of claim 37, 38, or 39, wherein the wound is a diabetic ulcer.

41. The method of claim 37, 38, or 39, wherein the wound is a burn.

42. The method of claim 37, 38, or 39, wherein the wound is caused by external trauma. N

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43. The method of claim 37, 38, or 39, wherein the wound is surgical penetration.

44. The method of claim 37, 38, or 39, wherein the wound is caused by flame or heat.

45. The method of claim 37, 38, or 39, wherein the wound is caused by a chemical.

46. The method of claim 37, 38, or 39, wherein the wound is caused by pressure.

47. The method of claim 37, 38, or 39, wherein the wound is caused by intrinsic skin failure.

48. The method of claim 37, 38, or 39, wherein the wound is circulatory insufficiency.

49. A kit, comprising a 30-day supply of the wound treatment device of any one of claims 1- 36, wherein the kit comprises 30 pairs of daily sterile disposable wound treatment devices for bilateral foot, arm, leg, or arm ulcers.

50. A kit, comprising a 30-day supply of the wound treatment device of any one of claims 1- 36, wherein the kit comprises 30-daily sterile disposable wound treatment devices for an ulcer on either a left foot, hand, arm or leg or a right foot, hand, arm, or leg.

51. A kit, comprising a 30-day supply of the wound treatment device of any one of claims 1- 36, wherein the kit comprises 3 daily sterile disposable wound treatment devices for the torso, neck, head, or genital regions.