WO2023023405A1 - Re-epithelializing dressing and treatment method - Google Patents

Re-epithelializing dressing and treatment method Download PDF

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Publication number
WO2023023405A1
WO2023023405A1 PCT/US2022/041115 US2022041115W WO2023023405A1 WO 2023023405 A1 WO2023023405 A1 WO 2023023405A1 US 2022041115 W US2022041115 W US 2022041115W WO 2023023405 A1 WO2023023405 A1 WO 2023023405A1
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Prior art keywords
transfer pad
wound
epithelializing
dressing
pad
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PCT/US2022/041115
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French (fr)
Inventor
David S. Zamierowski
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Zam Research Llc
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Publication of WO2023023405A1 publication Critical patent/WO2023023405A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96Suction control thereof
    • A61M1/962Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/0203Adhesive plasters or dressings having a fluid handling member
    • A61F13/05
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/92Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/94Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with gas supply means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00Devices for applying media, e.g. remedies, on the human body
    • A61M35/30Gas therapy for therapeutic treatment of the skin

Definitions

  • the present invention relates generally to wound treatment, and in particular to a dressing and method for re-epithelializing open, surface wounds and closed, incisional wounds.
  • Wound healing generally, and re-epithelialization particularly, can be enhanced by “controlling” airflow and drainage, i.e., absorptive drainage of serum and exudates in a composite wound dressing.
  • Negative pressure wound therapy (NPWT) systems and methods have been shown to alter wound healing histology and chemistry. Accelerated wound treatment can thereby be achieved.
  • Common suction/vacuum wound treatment system characteristics include negative pressure (vacuum) sources, e.g., manual and motorized pumps; patient interfaces for extracting exudates, such as hydrophilic or hydrophobic compressible foam materials; and various membrane materials for covering and draping the wound sites, which can be semi- permeable for ventilation.
  • Such systems can be configured for extracting and containing liquids, such as blood, serum and wound exudates. Both air and liquid (collectively “fluids”) can be introduced and extracted. Growth factors, anti-microbial agents, local anesthetics and other beneficial fluids can be introduced for optimizing healing results.
  • Systems can be programmed for intermittent negative pressure cycles and can be coordinated with introduction/extraction cycles for fluids.
  • Previous wound treatment systems variably controlled negative pressure forces and timing.
  • microprocessor-controlled, interactive patient-system feedback techniques can be used for monitoring treatment progress.
  • primary intention healing generally refers to actively drawing the wound edges together. Sutures, staples, adhesives, and the like have been utilized in primary intention, wound closure procedures. Secondary intention healing, on the other hand, generally involves allowing wounds to contract and close by the innate forces and processes inherent in the tissues themselves. Secondary intention healing by natural, spontaneous tissue response tends to be relatively slow. The tissue forces at play here are the contraction achieved by fibroblasts and collagen and the “covering” of the wound achieved by epithelial migration. [0009] A wound that loses its functional epidermal tissue cover is generally considered “open.” This functional epidermal layer is approximately the thickness of a blister top.
  • the practitioner can take a type of “second-intention” approach to these superficial wounds and let the body “scab” the exuding serum and wound exudate and expect the residual epithelial elements and the epithelium at the wound edges to migrate and then mature beneath the scab. Finally, when the new epithelium has matured to form the functional layers of replicating, dying, drying keratin-filled cells (called stratum lucidum), the scab will peel or separate spontaneously - a process that takes 3-4 weeks generally.
  • Stage 1 we have epithelial migration, in an advancing sheet of cells just a few cells thick. This sheet advances under a scab in several days in a second- degree injury or incisional wound, perhaps averaging 3-5 days. Under many types of moist wound healing dressings, it makes this progress of advancing in as little as 1-2 days.
  • Stage 2 the maturing of this several cell thick layer into a layer of multiple cells (dozens in some situation) which have time to form keratin and then undergo apoptosis and leave their compressed keratin bodies as a fusing layer that forms the water barrier and bacterial and external environment barrier that is the stratum lucidum takes, on average, several weeks not days.
  • the base layer of epithelium continues to undergo cell division and outwardly pushes these cells, the epidermal structure that is the hallmark of mature skin is formed. Under special conditions, this can happen in as short as one week. But normally, especially if a scab is involved, this may take 3-4 weeks.
  • an ideal dressing for re-epithelialization as first described by Winter and Errede would have surface contact continuously and would initially for “stage 1” healing, maintain a moist environment and then, without changing the dressing, would allow drying for stage 2 healing as the amount of exudate and water vapor loss from the wound decreases and would provide protection to the maturing skin while it dries and then when it is mature, allow spontaneous separation from the skin surface.
  • This present invention accomplishes these aims by introducing integrated mechanically assisted drying to the dressing, thus allowing maximized healing for both stage 1 and stage 2 re-epithelialization with the same dressing.
  • Maturation of the migrating epithelium and closure of the narrow edge gaps across an incision or around an unmeshed STSG proceeds to completion (i.e., to maturation of the epithelial layer) under almost any conditions and can essentially be ignored.
  • epithelium healing by migration over some distance, followed by maturing in place can be a tenuous and uncertain process that must be protected while the epithelial cells replicate, with each new layer moving the previous layer outward and upward.
  • the outward-and-upward moving cells undergo apoptosis or death and leave keratin-filled dead cell bodies to form the new stratum lucidum or functional layer of mature skin.
  • Incisional dressings with V.A.C. (tm) system components by KCI+3M consist of liners covered by reticular foam that collapses on application of negative pressure (over 50mm Hg). This maintains intimate contact and is used for the epithelialization across incisions and for the stabilization of underlying dissections. Its use requires an external motor connected by tubing to the foam pad and liner, all of it held in place by adhesive plastic film or drape. The collapse of the foam transfers the ambient air pressure differential achieved by the motorized vacuum and makes this a negative pressure wound therapy (NPWT) dressing.
  • NGWT negative pressure wound therapy
  • the present invention is generally indicated for improving outcomes during a second stage of the re-ephitilization process of wound healing with drying and stabilizing intentions.
  • Re-epithelializing wounds are treated with a surface contact dressing including an integral, self-contained fan unit.
  • the fan unit maintains circulating airflow over the wound area via a semi-permeable membrane cover admitting ambient atmosphere and a porous mat in contact with the wound and regenerating epithelium. Serum and wound exudate can be dried by evaporation.
  • the re-epithelializing, wound-drying dressing of the present invention is generally indicated:
  • the qualities of the wound dressing we desire for re-epithelialization include the following:
  • this pad In order to be used on surgical wounds or freshly debrided wounds with active bleeding then, this pad must provide good hemostatic capability, so we do not acquire a collection of blood from active bleeding.
  • There is no intrinsic pressure in a vector vertical and perpendicular to the surface with this dressing unlike dressing systems that employ a motorized pump for vacuum to achieve negative pressure inside the dressing components and so utilize the compression from the ambient air collapse of the dressing to maintain intimate surface contact (e.g., The VAC (TM) by KCI and 3M). So, when this type of pad is applied to the surface with application of this dressing system being described, the external pressure to ensure contact and hemostasis needs to be applied manually - for up to 15 minutes if the patient is on blood thinners for example.
  • Fabric hemostasis is achieved by the close weaving of almost any material (i.e., hydrophilic or hydrophobic) as long as the threads are thin enough to allow the passage of exudate between them and woven or extruded or poured so that it is not a sheet that is impervious to liquids (example, like the plastic overdrape for this system which is impervious to liquids but permeable to air and gas
  • Apligraf is a commercially prepared cultured homograft that is delivered as a bi-layered skin graft product.
  • the company's recommended method of application specifies to "mesh" the product by hand before placing - thus creating a meshed graft that will drain and allow serum and exudate up into the pad ensuring good surface contact. If, as the Apligraf dressing application instructions offer, one wishes to cover the graft area with a compressive wrap (e.g., for extremities), this dressing system should not have the wrap cover the motorized fan. This area should be left out of the wrap, first to prevent a pressure injury, but also to improve the air exchange and prevent blockage of the vents.
  • a compressive wrap e.g., for extremities
  • the dressing material in this case becomes part of the scab and the entire complex separates (generally after 3-4 weeks) when the epithelium has matured, and the upper keratin layers can slough off.
  • the dressing can also assist the formation of a scab that is very thin and dries beneath the dressing, barely incorporating it.
  • This adjunct illustrated in the figures is the early use of washing or rinsing through the optional ports. Appropriate small amounts of the desired solution (small enough for each treatment cycle so as not to overwhelm the perimeter adhesive seal of the overdrape) are injected as irrigation and then withdrawn. This (repeated) rinsing early in the scab formation cycle will reduce and thin the amount of serum exudate in the pad, thereby thinning the resulting scab and making it more flexible.
  • the trade-off for this type of pad is that it is more difficult to hold in intimate surface contact. So, to use a larger burn of the upper arm onto the shoulder as an example, the flatter, convex portion of the limb between the joints could have the applied meshed STSG covered with the foam pads and plastic film overdrape and an outer circumferential wrap holding the entire system in place - with the wrap leaving out the multiple fans placed at strategic points.
  • the joints and the axilla beneath the shoulder would be dressed with pieces of woven matting, cut into small pieces that fit together and then held with the overdrape and then a bolus of gauze dressing wrapped in place, again avoiding the multiple fan patches placed at strategic points outside the joints.
  • the material for the pad or mat portion of this dressing are highly porous to air such that the air moves through all the dressing toward the fan vent allowing all areas of the dressing to dry and remain dry. Just as with natural scab formation, it is this drying that is our bacterial control mechanism. "Moist wound healing" occurs only early in epithelial migration and only beneath this assisted scab we are forming. Once the scab forms (a matter of days), the purpose of the dressing is then to facilitate approximately three or more weeks of "drying" until spontaneous separation from the matured epithelium.
  • Fig. 1 is a cross-sectional view of a re-epithelialization dressing applied to a wound at Stage 1.
  • Fig. la is a fragmentary plan view of the dressing, taken generally along line la-la in Fig. 1.
  • Fig. 2 is a cross-sectional view of the dressing at Stage 2 with a scab-like dried exudate layer formed.
  • Fig. 3 is a cross-sectional view of the dressing at completion of Stage 2 with the dressing separating from the wound at the level of scabbing.
  • Fig. 4 is an alternative embodiment or aspect of the present invention with a fluid control system adapted for accommodating multiple configurations of dressing ports, fluid control components (e.g., pumps, fans, inputs, outputs, etc.) and suitable selective valve connections.
  • fluid control components e.g., pumps, fans, inputs, outputs, etc.
  • Fig. 5 is an alternative embodiment or aspect of the present invention with a topical oxygen treatment chamber administering oxygen to a wound via an input port and an outlet port, which can be connected to a discharge or a remote exhaust fan.
  • FIG. 6 shows another alternative embodiment or aspect of the present invention with an open-weave pad including open sides for air circulation and evaporative drawing, and an auto-detachable pad contact layer configured for becoming part of the scab.
  • Fig. 1 shows a re-epitheliazation dressing 2 embodying an aspect of the present invention.
  • the dressing 2 is shown applied to an open wound with a mashed split- thickness skin graft (STSG).
  • a felt or foam fluid transfer pad 6 is placed on the wound surface and covered by a semi-permeable membrane cover 8.
  • One or more fan units 10 can be placed on top of the transfer pad 6 beneath the membrane cover 8 and configured for drawing an ambient airflow through the transfer pad 6 to facilitate evaporative drying.
  • the dressing 2 can comprise a pre-sized, preassembled, peel-and-place dressing with an integral exhaust fan unit 10.
  • Figs. 2-4 show progressive treatment stages with the dressing 2.
  • the transfer pad 6 can begin separating from the healed epidermis, e.g., at its perimeter edges, as shown.
  • the dressing 2 can be completely removed when the wound is closed via matured re-epitheliazation.
  • FIG. 5 shows a first alternative or modified embodiment of the present invention with a dressing 102 forming a topical oxygen treatment chamber 104.
  • Oxygen (02) can be introduced from an oxygen administration cartridge 106 at a controlled rate via a rate control 108.
  • a three-way stopcock 110 is configured for diverting the 02 to a resistance control 112 for discharge to the atmosphere.
  • Various fluids can be introduced to facilitate wound healing and accelerate re- epitheliazation. These include other gas formulations, water vapor, antibiotics, growth factors, etc.
  • Fig. 6 shows a second alternative or modified embodiment of the present invention with a dressing 202 with an open- weave transfer pad 206 covered on its distal face by a cover membrane 208.
  • the cover membrane 208 can comprise a material with characteristics ranging from impermeable, semi-permeable to permeable.
  • semi- permeable materials can accommodate gas passage and generally block liquid passage.
  • An input/output port 210 can be mounted on the cover membrane 208 and configured for injecting medications into the dressing 202 and extracting fluids therefrom.
  • a fan unit assembly 212 can also be mounted on the membrane cover 207 and comprises a receptacle 214 and a fan unit 216, which can be removable and replaceable.
  • One or more input/output ports 210 and fan unit assemblies 212 can be placed on the cover membrane 208 for achieving a desired airflow pattern, volume and resultant drying effect.
  • one or more of the transfer pad side margins can be exposed to the atmosphere to facilitate ambient airflow and accelerate drying and re- epitheliazation.
  • Gauze can be initially placed over the dressing to accommodate wound drainage. Strapping or wrapping materials can be utilized for mounting the dressing 202 without adhesive.
  • a pad contact layer 208 is configured for automatically detaching from the overlying parts of the transfer pad 206 and becoming part of the scab. When the wound heals, or a dressing change is required, the transfer pad 206 is removed. The treatment caregiver can observe the healing progress.
  • the contact layer 208 left exposed to the air or covered with a light gauze wrapped, separates spontaneously when the epithelium is mature and able to be left unprotected.

Abstract

A re-epithelializing dressing includes a transfer pad with a contact layer for engaging an open wound or elsewhere on a patient. The transfer pad includes a porous core and a proximal, separate surface contact layer configured for engaging the wound, tissue. An impermeable, semi-permeable or permeable membrane can be placed over the transfer pad for airflow, which facilitates evaporative drying. Alternative embodiments of the dressing include auxiliary fluid subsystems, which can introduce, circulate and exhaust oxygen, growth factors and other fluids. Other alternative embodiments can provide one or more open side margins for the transfer pad, which can be attached to the patient without adhesive by using strapping and wrapping.

Description

RE-EPITHELIALIZING DRESSING AND TREATMENT METHOD CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. provisional application No. 63/235,578, filed August 20, 2021, which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates generally to wound treatment, and in particular to a dressing and method for re-epithelializing open, surface wounds and closed, incisional wounds. Wound healing generally, and re-epithelialization particularly, can be enhanced by “controlling” airflow and drainage, i.e., absorptive drainage of serum and exudates in a composite wound dressing.
2. Description of the Related Art
[0003] A wide variety of mechanically assisted drainage devices to aid wound healing and for use in surgery have been used for over 100 years. For example, springs and compressed-material recoil (primarily rubber and plastics) have been used to produce negative pressure or vacuum in buried, under-the-surface (i.e., subcutaneous) wound drains (e.g., Jackson-Pratt Drain) and in gastric aspiration tubing. Some such tubes (sump tubing) deliver an air flow to mix with the gastric aspirate to facilitate its extraction.
[0004] Negative pressure wound therapy (NPWT) systems and methods have been shown to alter wound healing histology and chemistry. Accelerated wound treatment can thereby be achieved.
[0005] Examples of prior art wound treatment systems and methods are shown in the following references, the contents of which are incorporated herein by reference: Errede, Stoesz and Winter (by Upton) US Patent No. 4,373,519 for Composite Wound Dressing issued February 15, 1983; Errede, Stoesz and Upton US Patent No. 4,460,642 for Water- Swellable Composite Sheet of Microfibers of PTFE and Hydrophilic Absorptive Particles issued July 17, 1984; Zamierowski et al. US Patent No. 6,951,553 for Tissue Closure Treatment System and Method of Externally-Applied Patient Interface issued October 4, 2005; Bubb et al. US Patent No. 6,936,037 for Tissue Closure Treatment System, Patient Interface and Method issued August 30, 2005; Zamierowski US Patent No. 6,071,267 for Medical Patient Fluid Management Interface System and Method issued June 6, 2000; Zamierowski, US Patent No. 7,381,221 for Medical Closure Screen Device and Method issued June 3, 2008; Zamierowski US Patent No. 7,108,683 for Wound Therapy and Tissue Management System and Method with Fluid Differentiation issued September 19, 2006; Zamierowski US Patent No. 2,483,654 for Wound Therapy and Tissue Treatment Management System and Method with Fluid Differentiation issued August 5, 2008; Zamierowski US Patent 7,645,269 for Gradient Wound Treatment System and Method issued January 12, 2010; Zamierowski US Patent No. 10,420,847 for System and Method for Wound Array Variables Evaluation (WAVE) issued September 24, 2019; Bubb et al. US Patent 7,976,519 for Externally-Applied Patient Interface System and Method issued July 12, 2011; Bubb et al. US 8,956,335 for Externally- Applied Patient Interface System and Method issued February 17, 2015; Zamierowski et al. US Patent 10,363,344 for Externally-Applied Patient Interface System and Method with a Controlled Region for Implanted or Buried BioReactor issued July 30, 2019; and Bubb et al. US Patent No. 9,968,448 for Externally- Applied Patient Interface System and Method issued May 15, 2018.
[0006] Common suction/vacuum wound treatment system characteristics include negative pressure (vacuum) sources, e.g., manual and motorized pumps; patient interfaces for extracting exudates, such as hydrophilic or hydrophobic compressible foam materials; and various membrane materials for covering and draping the wound sites, which can be semi- permeable for ventilation. Such systems can be configured for extracting and containing liquids, such as blood, serum and wound exudates. Both air and liquid (collectively “fluids”) can be introduced and extracted. Growth factors, anti-microbial agents, local anesthetics and other beneficial fluids can be introduced for optimizing healing results.
[0007] Systems can be programmed for intermittent negative pressure cycles and can be coordinated with introduction/extraction cycles for fluids. Previous wound treatment systems variably controlled negative pressure forces and timing. For example, microprocessor-controlled, interactive patient-system feedback techniques can be used for monitoring treatment progress.
[0008] In wound healing, primary intention healing generally refers to actively drawing the wound edges together. Sutures, staples, adhesives, and the like have been utilized in primary intention, wound closure procedures. Secondary intention healing, on the other hand, generally involves allowing wounds to contract and close by the innate forces and processes inherent in the tissues themselves. Secondary intention healing by natural, spontaneous tissue response tends to be relatively slow. The tissue forces at play here are the contraction achieved by fibroblasts and collagen and the “covering” of the wound achieved by epithelial migration. [0009] A wound that loses its functional epidermal tissue cover is generally considered “open.” This functional epidermal layer is approximately the thickness of a blister top. So superficial injuries can result in loss of only the epidermal layer (scrapes, abrasions, blistering, superficial bums) while the deeper dermis remains intact and there is no need for the body to “contract” the wound. In these cases, no contraction is needed, and epithelial coverage can be achieved by the residual remnants of epidermis (skin glands, hair follicles) that are present in the deep dermis of the wound tissue - each island of epidermis radially migrating out to resurface the wound.
[0010] The practitioner can take a type of “second-intention” approach to these superficial wounds and let the body “scab” the exuding serum and wound exudate and expect the residual epithelial elements and the epithelium at the wound edges to migrate and then mature beneath the scab. Finally, when the new epithelium has matured to form the functional layers of replicating, dying, drying keratin-filled cells (called stratum lucidum), the scab will peel or separate spontaneously - a process that takes 3-4 weeks generally.
[0011] Only with the development of the microscope and histologic examination of the wound was the distinction between wounds with and without residual epithelial elements able to be fully understood. So, for millennia before this, the accepted, desired sequence of events for “superficial” injury with loss of epidermis but retention or preservation of deep dermis and residual epithelial elements (in burns this is called “second degree” injury) was included in the term “second-intention healing” just as deep tissue injury and loss were. As the distinction between deep and superficial or second-degree injuries has become clearer over the last several hundred years, the applicability of the term “intention” have become less clear.
[0012] This is important for the present invention because we are referring to a dressing that will cause a “scab” type of healing and is particularly applicable to partial thickness injuries with residual epithelial elements and to narrow full thickness injuries (for example lacerations or incisions separated only because of the elastic fiber action in the deep dermis but which can readily heal by simple advancement of the epithelium from the near-by edges of the wound). It is also applicable to full thickness wounds where re-epithelialization across a wider area without residual epithelial islands is aided by use of growth factors, cultured homografts (e.g., ApligrafTM), pinch grafts and actual grafting of sheets of autograft skin.
[0013] The straight-forward concepts of “scabbing” and “intention” healing were completely up-ended and complicated 60 years ago by G. D. Winter, PhD. In his publication in 1963 in Nature, he showed that “scabbing” slowed down epithelial migration compared to “moist wound healing.” In the intervening years the wound healing industry and field has seen the emphasis on moist wound healing. In this emphasis, an important physiologic fact and principle has sometimes been sacrificed and sometimes completely lost in understanding - and that is that in order for the recently migrated epithelial layer to mature (thicken and form the stratum lucidum) the epithelium MUST be dried. G. D. Winter himself clearly recognized this as evidenced by his writing in his Lyofoam paper and in the posthumously published Errede patent cited above. But these are infrequently referenced papers.
[0014] In order to understand this clearly, I am going to refer to these two phases of epithelial healing as “stages.” In Stage 1 we have epithelial migration, in an advancing sheet of cells just a few cells thick. This sheet advances under a scab in several days in a second- degree injury or incisional wound, perhaps averaging 3-5 days. Under many types of moist wound healing dressings, it makes this progress of advancing in as little as 1-2 days.
[0015] Stage 2, the maturing of this several cell thick layer into a layer of multiple cells (dozens in some situation) which have time to form keratin and then undergo apoptosis and leave their compressed keratin bodies as a fusing layer that forms the water barrier and bacterial and external environment barrier that is the stratum lucidum takes, on average, several weeks not days. As the base layer of epithelium continues to undergo cell division and outwardly pushes these cells, the epidermal structure that is the hallmark of mature skin is formed. Under special conditions, this can happen in as short as one week. But normally, especially if a scab is involved, this may take 3-4 weeks.
[0016] Thus, an ideal dressing for re-epithelialization as first described by Winter and Errede would have surface contact continuously and would initially for “stage 1” healing, maintain a moist environment and then, without changing the dressing, would allow drying for stage 2 healing as the amount of exudate and water vapor loss from the wound decreases and would provide protection to the maturing skin while it dries and then when it is mature, allow spontaneous separation from the skin surface. This present invention accomplishes these aims by introducing integrated mechanically assisted drying to the dressing, thus allowing maximized healing for both stage 1 and stage 2 re-epithelialization with the same dressing.
[0017] Maturation of the migrating epithelium and closure of the narrow edge gaps across an incision or around an unmeshed STSG proceeds to completion (i.e., to maturation of the epithelial layer) under almost any conditions and can essentially be ignored. But epithelium healing by migration over some distance, followed by maturing in place, can be a tenuous and uncertain process that must be protected while the epithelial cells replicate, with each new layer moving the previous layer outward and upward. The outward-and-upward moving cells undergo apoptosis or death and leave keratin-filled dead cell bodies to form the new stratum lucidum or functional layer of mature skin. [0018] The crux of the issue is that to accomplish this final maturation, the skin must be dried as well as protected. The normal method that nature uses to accomplish this is to form a “scab” and this epithelial maturation process occurs beneath its protective layer. See Errede, Stoesz and Winter-Upton U.S. Patents No. 4,373,519 and No. 4,460,642, which are incorporated herein by reference. These patents teach that the epithelial migration to cover a wounded area occurs faster if that wound is kept moist. They also teach that that this fresh, fragile layer of advancing epithelium, which is only a few cells thick, can be stabilized and allowed to mature and dry best if covered with a contact layer that produces intimate contact and stability - just like nature’s “scab” - as well as allowing drying for maturation.
However, these re-epithelialization protocols presented by the experiments and proposals of Winter and Errede tended to be most effective with relatively small (e.g., one square inch) areas, but were not as effective over larger areas. Hence, the re-epithelialization protocols with this product line were not easily scaled up. Larger pads and films of different manufacturers did not maintain intimate contact with the irregular surfaces of the human body thereby forming spaces that allowed fluid to form and collect that did not achieve the drying necessary for epithelial maturation. As clearly shown in Winter’s experiments, this resulted in subsequent destruction of the epithelial layer.
[0019] Incisional dressings with V.A.C. (tm) system components by KCI+3M consist of liners covered by reticular foam that collapses on application of negative pressure (over 50mm Hg). This maintains intimate contact and is used for the epithelialization across incisions and for the stabilization of underlying dissections. Its use requires an external motor connected by tubing to the foam pad and liner, all of it held in place by adhesive plastic film or drape. The collapse of the foam transfers the ambient air pressure differential achieved by the motorized vacuum and makes this a negative pressure wound therapy (NPWT) dressing.
SUMMARY OF THE INVENTION
[0020] The present invention is generally indicated for improving outcomes during a second stage of the re-ephitilization process of wound healing with drying and stabilizing intentions. Re-epithelializing wounds are treated with a surface contact dressing including an integral, self-contained fan unit. The fan unit maintains circulating airflow over the wound area via a semi-permeable membrane cover admitting ambient atmosphere and a porous mat in contact with the wound and regenerating epithelium. Serum and wound exudate can be dried by evaporation. [0021] The re-epithelializing, wound-drying dressing of the present invention is generally indicated:
• for all surgical incisions except those associated with bone work or extensive subcutaneous dissections. So applicable incisions would also include those directly into body compartments such as laparotomy and thoracotomy procedures;
• for meshed skin grafts with open areas that need to re-epithelialize;
• for open surfaces re-epithelializing with growth factors;
• for cultured homografts, e.g., using the Apligraf® wound treatment products of Organogenesis Inc.;
• pinch grafts;
• abrasions healing with scabs or needing a scab-like dressing to heal; and
• Second-degree bums.
• Ideal for topical oxygen therapy
[0022] For many of these cases, collapsing or compressing a foam portion of a negative pressure dressing is not necessary. Therefore, conventional NPWT dressings, systems and protocols may not be necessary or indicated. In such cases, this re-epithelialization phase of wound healing can be accomplished with drying, stabilizing and surface contact.
[0023] The qualities of the wound dressing we desire for re-epithelialization include the following:
I. Intimate Surface Contact While Re-Epithelialization Is Occurring
[0024] In order to place this dressing (so we are primarily talking about the pad or mat that goes directly on the skin graft and/or wound to be re-epithelialized) on wounds that are raw and/or are going to weep, the dressing must be adherent to this tissue and not allow any space between the raw surface and the pad that would allow the collection of fluid or exudate or blood or even an air space. The drainage that might occur from the surface needs to be absorbed up into the dressing pad so that the pad maintains intimate contact with the surface itself.
II. Fabric Hemostasis Ability
[0025] In order to be used on surgical wounds or freshly debrided wounds with active bleeding then, this pad must provide good hemostatic capability, so we do not acquire a collection of blood from active bleeding. There is no intrinsic pressure in a vector vertical and perpendicular to the surface with this dressing, unlike dressing systems that employ a motorized pump for vacuum to achieve negative pressure inside the dressing components and so utilize the compression from the ambient air collapse of the dressing to maintain intimate surface contact (e.g., The VAC (TM) by KCI and 3M). So, when this type of pad is applied to the surface with application of this dressing system being described, the external pressure to ensure contact and hemostasis needs to be applied manually - for up to 15 minutes if the patient is on blood thinners for example. But after that, as the exudate dries enmeshed in the pad, the pad is then firmly bound to the surface of the wound. Because there is no motorized compression with this dressing, it cannot be used on an unmeshed split thickness skin graft (STSG) as a compression bolus dressing. A meshed STSG will allow the spot welding of the dressing to the surface at all the meshed openings that will ooze a small amount of serum and exudate. Fabric hemostasis is achieved by the close weaving of almost any material (i.e., hydrophilic or hydrophobic) as long as the threads are thin enough to allow the passage of exudate between them and woven or extruded or poured so that it is not a sheet that is impervious to liquids (example, like the plastic overdrape for this system which is impervious to liquids but permeable to air and gas
[0026] An example of an additional STSG that this dressing can be employed with is Apligraf. This is a commercially prepared cultured homograft that is delivered as a bi-layered skin graft product. The company's recommended method of application specifies to "mesh" the product by hand before placing - thus creating a meshed graft that will drain and allow serum and exudate up into the pad ensuring good surface contact. If, as the Apligraf dressing application instructions offer, one wishes to cover the graft area with a compressive wrap (e.g., for extremities), this dressing system should not have the wrap cover the motorized fan. This area should be left out of the wrap, first to prevent a pressure injury, but also to improve the air exchange and prevent blockage of the vents.
III. Flexibility
[0027] Maintenance of intimate surface contact is relatively easier with a small dressing pad size (1-2-inch diameter) and a convex surface to which it is applied (e.g., the section of limbs between joints and the majority of the torso). However, for larger areas, especially if they include the areas over joints and between body folds, the dressing pad must have 3- dimensional flexibility - the ability to compress and/or expand in three axes. This is achieved by a two directional weave that is then layered to the desired thickness with the layering interconnected in 3 dimensions so as to form a pad or mat rather than just a sheet, the weave being close enough to accomplish the prevention of tissue in-growth (e.g., the 33/44 weave of fine mesh gauze) but open enough to allow the absorption of exudate and serum. Large pieces can easily be wrapped around the long sections of limbs and over the flat areas of the torso, but application to difficult contours over joints and folds may require the cutting of the pad into smaller individual units that can move freely one on the other and then held in place by the overdrape with the motorized fan(s) placed at some secure non-bending position just outside this construct, With this approach, virtually every surface area of the body can be covered with this device.
IV. Ability to absorb exudate and allow it to dry
[0028] We are all familiar with the natural method the body provides of forming a thin, adherent scab as the final step in maturing a re-epithelialized area. This desired dressing property would actually promote the development of an "assisted scab" that is thinner, and therefore more flexible, and allows faster drying and maturation of the epithelium. This dressing material could be made of materials, primarily hydrophobic or hydrophilic, which allow the exudate to incorporate the entire or the lower layers (those in direct contact with the wound surface). This would be more likely with hydrophilic materials.
[0029] The dressing material in this case becomes part of the scab and the entire complex separates (generally after 3-4 weeks) when the epithelium has matured, and the upper keratin layers can slough off. The dressing can also assist the formation of a scab that is very thin and dries beneath the dressing, barely incorporating it. One example of this adjunct illustrated in the figures is the early use of washing or rinsing through the optional ports. Appropriate small amounts of the desired solution (small enough for each treatment cycle so as not to overwhelm the perimeter adhesive seal of the overdrape) are injected as irrigation and then withdrawn. This (repeated) rinsing early in the scab formation cycle will reduce and thin the amount of serum exudate in the pad, thereby thinning the resulting scab and making it more flexible.
[0030] One can also use thin foams that have small cell (closed or open but must be thin enough to allow evaporative water loss and air exchange) or compressed surfaces against the wound contact surface and then larger open cell pores above to allow for greater evaporative drying. The trade-off for this type of pad is that it is more difficult to hold in intimate surface contact. So, to use a larger burn of the upper arm onto the shoulder as an example, the flatter, convex portion of the limb between the joints could have the applied meshed STSG covered with the foam pads and plastic film overdrape and an outer circumferential wrap holding the entire system in place - with the wrap leaving out the multiple fans placed at strategic points. The joints and the axilla beneath the shoulder would be dressed with pieces of woven matting, cut into small pieces that fit together and then held with the overdrape and then a bolus of gauze dressing wrapped in place, again avoiding the multiple fan patches placed at strategic points outside the joints.
V. Ability to easily pass air and allow drying
[0031] Preferably, the material for the pad or mat portion of this dressing are highly porous to air such that the air moves through all the dressing toward the fan vent allowing all areas of the dressing to dry and remain dry. Just as with natural scab formation, it is this drying that is our bacterial control mechanism. "Moist wound healing" occurs only early in epithelial migration and only beneath this assisted scab we are forming. Once the scab forms (a matter of days), the purpose of the dressing is then to facilitate approximately three or more weeks of "drying" until spontaneous separation from the matured epithelium.
[0032]
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Embodiments of the current invention are described in detail below with reference to the attached drawing figures, wherein:
[0034] Fig. 1 is a cross-sectional view of a re-epithelialization dressing applied to a wound at Stage 1.
[0035] Fig. la is a fragmentary plan view of the dressing, taken generally along line la-la in Fig. 1.
[0036] Fig. 2 is a cross-sectional view of the dressing at Stage 2 with a scab-like dried exudate layer formed.
[0037] Fig. 3 is a cross-sectional view of the dressing at completion of Stage 2 with the dressing separating from the wound at the level of scabbing.
[0038] Fig. 4 is an alternative embodiment or aspect of the present invention with a fluid control system adapted for accommodating multiple configurations of dressing ports, fluid control components (e.g., pumps, fans, inputs, outputs, etc.) and suitable selective valve connections.
[0039] Fig. 5 is an alternative embodiment or aspect of the present invention with a topical oxygen treatment chamber administering oxygen to a wound via an input port and an outlet port, which can be connected to a discharge or a remote exhaust fan.
[0040] Fig. 6 shows another alternative embodiment or aspect of the present invention with an open-weave pad including open sides for air circulation and evaporative drawing, and an auto-detachable pad contact layer configured for becoming part of the scab. [0041] The drawing figures do not limit the current invention to the specific embodiments disclosed and described herein. The drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
I. Introduction and Environment
[0042] As required, detailed aspects of the present invention are disclosed herein, however, it is to be understood that the disclosed aspects are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art how to variously employ the present invention in virtually any appropriately detailed structure.
[0043] Certain terminology will be used in the following description for convenience in reference only and will not be limiting. For example, up, down, front, back, right, and left refer to the invention as orientated in the view being referred to. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the aspect being described and designated parts thereof. Additionally, anatomical terms are given their usual meanings. For example, proximal means closer to the trunk of the body, and distal means further from the trunk of the body. Said terminology will include the words specifically mentioned, derivatives thereof, and words of similar meaning.
II. Re-Epitheliazation Dressing 2
[0044] Fig. 1 shows a re-epitheliazation dressing 2 embodying an aspect of the present invention. Without limitation on the generality of useful applications of the present invention, the dressing 2 is shown applied to an open wound with a mashed split- thickness skin graft (STSG). A felt or foam fluid transfer pad 6 is placed on the wound surface and covered by a semi-permeable membrane cover 8. One or more fan units 10 can be placed on top of the transfer pad 6 beneath the membrane cover 8 and configured for drawing an ambient airflow through the transfer pad 6 to facilitate evaporative drying. The dressing 2 can comprise a pre-sized, preassembled, peel-and-place dressing with an integral exhaust fan unit 10.
[0045] Figs. 2-4 show progressive treatment stages with the dressing 2. Upon re- epitheliazation of the open wound 4, the transfer pad 6 can begin separating from the healed epidermis, e.g., at its perimeter edges, as shown. The dressing 2 can be completely removed when the wound is closed via matured re-epitheliazation.
III. First Alternative Embodiment (Fig. 5) [0046] Fig. 5 shows a first alternative or modified embodiment of the present invention with a dressing 102 forming a topical oxygen treatment chamber 104. Oxygen (02) can be introduced from an oxygen administration cartridge 106 at a controlled rate via a rate control 108. A three-way stopcock 110 is configured for diverting the 02 to a resistance control 112 for discharge to the atmosphere.
[0047] Various fluids can be introduced to facilitate wound healing and accelerate re- epitheliazation. These include other gas formulations, water vapor, antibiotics, growth factors, etc.
IV. Second Alternative Embodiment (Fig. 6)
[0048] Fig. 6 shows a second alternative or modified embodiment of the present invention with a dressing 202 with an open- weave transfer pad 206 covered on its distal face by a cover membrane 208. The cover membrane 208 can comprise a material with characteristics ranging from impermeable, semi-permeable to permeable. For example, semi- permeable materials can accommodate gas passage and generally block liquid passage.
[0049] An input/output port 210 can be mounted on the cover membrane 208 and configured for injecting medications into the dressing 202 and extracting fluids therefrom. A fan unit assembly 212 can also be mounted on the membrane cover 207 and comprises a receptacle 214 and a fan unit 216, which can be removable and replaceable. One or more input/output ports 210 and fan unit assemblies 212 can be placed on the cover membrane 208 for achieving a desired airflow pattern, volume and resultant drying effect.
[0050] In this configuration, one or more of the transfer pad side margins can be exposed to the atmosphere to facilitate ambient airflow and accelerate drying and re- epitheliazation.
[0051] Gauze can be initially placed over the dressing to accommodate wound drainage. Strapping or wrapping materials can be utilized for mounting the dressing 202 without adhesive. A pad contact layer 208 is configured for automatically detaching from the overlying parts of the transfer pad 206 and becoming part of the scab. When the wound heals, or a dressing change is required, the transfer pad 206 is removed. The treatment caregiver can observe the healing progress. The contact layer 208, left exposed to the air or covered with a light gauze wrapped, separates spontaneously when the epithelium is mature and able to be left unprotected.
V. Conclusion [0052] It is to be understood that while certain embodiments and/or aspects of the invention have been shown and described, the invention is not limited thereto and encompasses various other embodiments and aspects.

Claims

CLAIMS Having thus described the invention, what is claimed as new and desired to be secured by Letters Patent is:
1. A re-epithelializing dressing for a surface wound comprising: a porous fluid transfer pad assembly configured for placement on a surface of the wound; and a fan unit fluidically connected to said fluid transfer pad and configured for drawing an air current through said fluid transfer pad whereby serum, exudate and water vapor discharge by said wound are dried.
2. The re-epithelializing dressing according to claim 1, which includes: said transfer pad assembly including a porous transfer pad with proximal and distal faces and sides surrounding a transfer pad core; a wound contact layer mounted on said transfer pad proximal face and configured for bonding with wound exudate; said transfer pad configured for separating from said wound contact layer; and said transfer pad having an open side configured for admitting airflow into said transfer pad.
3. The re-epithelializing dressing according to claim 2, wherein said transfer pad core comprises a hydrophilic material.
4. The re-epithelializing dressing according to claim 2, wherein said transfer pad core comprises a hydrophobic material.
5. The re-epithelializing dressing according to claim 2, wherein said transfer pad substantially maintains its configuration throughout a wound treatment procedure.
6. The re-epithelializing dressing according to claim 2, which includes a distal membrane mounted on said transfer pad core at said transfer pad, distal face.
7. The re-epithelializing dressing according to claim 6, which includes a fan unit patch mounted on said distal membrane.
8. The re-epithelializing dressing according to claim 6, which includes a port mounted on said distal membrane and configured for introducing and extracting fluids to and from said core, respectively.
9. The re-epithelializing dressing according to claim 6 wherein said membrane comprises a material chosen from the group comprising: impermeable to liquids and gases; semi-permeable; and permeable to liquids and gases.
10. The re-epithelializing dressing according to claim 7, which includes multiple said fan units mounted on said distal membrane.
11. A sequential method of re-epithelializing a wound, which comprises the steps of: providing a fluid transfer pad including proximal and distal surfaces and a side margin; providing said fluid transfer pad with a porous core; providing said fluid transfer pad with a wound surface contact layer at said transfer pad proximal face; providing said transfer pad with a membrane at said transfer pad distal surface; placing said transfer pad on a surface of said wound with said pad contact layer engaging said wound; exposing said fluid transfer pad side margin to atmosphere; providing a fan unit and placing said fan unit on said membrane; drawing an air current through said fluid transfer pad with said fan unit; receiving one or more of serum, exudate and water vapor discharge from said wound in said fluid transfer pad; drying said serum, exudate or water vapor discharge from said wound with the air current from said fan unit; and removing said fluid transfer pad core from said pad contact layer.
PCT/US2022/041115 2021-08-20 2022-08-22 Re-epithelializing dressing and treatment method WO2023023405A1 (en)

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