HU0302301A2 - SIS combination vacuum bandage and bandage wounds such recovery procedure and using - Google Patents

SIS combination vacuum bandage and bandage wounds such recovery procedure and using Download PDF

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Publication number
HU0302301A2
HU0302301A2 HU0302301A HU0302301A HU0302301A2 HU 0302301 A2 HU0302301 A2 HU 0302301A2 HU 0302301 A HU0302301 A HU 0302301A HU 0302301 A HU0302301 A HU 0302301A HU 0302301 A2 HU0302301 A2 HU 0302301A2
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HU
Hungary
Prior art keywords
wound
layer
vacuum
sis
collagen
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Application number
HU0302301A
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Hungarian (hu)
Inventor
Arthur C. Coffey
Original Assignee
Arthur C. Coffey
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority to US20622600P priority Critical
Application filed by Arthur C. Coffey filed Critical Arthur C. Coffey
Priority to PCT/US2001/015611 priority patent/WO2001089431A1/en
Publication of HU0302301A2 publication Critical patent/HU0302301A2/en

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    • 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
    • A61F13/00004Non-adhesive dressings
    • A61F13/00008Non-adhesive dressings characterized by the material
    • A61F13/00012Non-adhesive dressings characterized by the material being made of natural material, e.g. cellulose-, protein-, collagen-based
    • 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
    • A61F13/00051Accessories for dressings
    • A61F13/00068Accessories for dressings specially adapted for application or removal of fluid, e.g. irrigation or drainage of wounds, under-pressure wound-therapy
    • 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
    • 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
    • A61F13/0216Adhesive plasters or dressings having a fluid handling member the fluid handling member being non absorbent, e.g. for use with sub- or over-pressure therapy, wound drainage or wound irrigation systems
    • 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
    • A61F13/022Adhesive plasters or dressings having a fluid handling member having more than one layer with different fluid handling characteristics
    • 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
    • A61F13/0226Adhesive plasters or dressings having a fluid handling member characterised by the support layer
    • 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
    • A61F13/0246Adhesive plasters or dressings characterised by the skin adhering layer
    • A61F13/0253Adhesive plasters or dressings characterised by the skin adhering layer characterized by the adhesive material
    • 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
    • A61F17/00First-aid kits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/225Mixtures of macromolecular compounds
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    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • A61L15/325Collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/40Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/44Medicaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/58Adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24Collagen
    • 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
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • 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
    • A61M27/00Drainage appliances for wounds or the like, i.e. wound drains, implanted drains
    • 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
    • A61F2013/00089Wound bandages
    • A61F2013/0017Wound bandages possibility of applying fluid
    • A61F2013/00174Wound bandages possibility of applying fluid possibility of applying pressure
    • AHUMAN NECESSITIES
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    • 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
    • A61F2013/00089Wound bandages
    • A61F2013/00357Wound bandages implanted wound fillings or covers
    • 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
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00536Plasters use for draining or irrigating wounds
    • AHUMAN NECESSITIES
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    • 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
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/0054Plasters use for deep wounds
    • AHUMAN NECESSITIES
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    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00855Plasters pervious to air or vapours
    • A61F2013/00859Plasters pervious to air or vapours with macroscopic openings
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    • 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
    • A61F2013/00361Plasters
    • A61F2013/00902Plasters containing means
    • A61F2013/00927Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
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    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • AHUMAN NECESSITIES
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    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/34Materials or treatment for tissue regeneration for soft tissue reconstruction

Abstract

A combination of SIS and vacuum bonding and such a bonding procedure for treating wounds. FIELD OF THE INVENTION The present invention relates to a wound dressing (10) to aid in the healing of a wound (12). The bond (10) comprises an SIS layer (14) disposed on the wound surface (16) and a cover layer (18) above the wound (12). The bond (10) further comprises a device (20) for forming a vacuum space (22). The wound treatment procedure (10) is applied to the wound and vacuum is created in the vacuum chamber (22). thereby regulating the suction of blood from the wound (12) to the SIS layer (14). HE

Description

EXTRACT

A combination of SIS and vacuum bonding and a method of treating wounds using such a bond

A combination of SIS and vacuum bonding and a method of treating wounds using such a bond.

FIELD OF THE INVENTION The present invention relates to a wound dressing (10) to aid in the healing of a wound (12). The bond (10) comprises an SIS layer (14) disposed on the wound surface (16) and a cover layer (18) above the wound (12). The bond (10) further comprises a device (20) for forming a vacuum space (22). In the wound treatment process, the bond (10) thus formed is placed on the wound and a vacuum is created in the vacuum space (22), thereby controlling the suction of blood from the wound (12) into the SIS layer (14).

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A combination of SIS and vacuum bonding and a method of treating wounds using such a bond

The present invention relates to a method and a bond for the treatment of wounds, preferably using a combination of SIS and vacuum.

A method known in the art of wound healing is to place small intestinal mucosa (SIS) layers directly on the scar-free and cleaned open wound. The description of the SIS is dealt with in U.S. Patent Nos. 5,855,619, 5,866

414, 5 753 267, 5 762 966, 5 755 791, 4 902 508, 4 956 178, 5

275,826, 5,281,422, 4,352,463, 5,372,821, 5,445,833, 5,516,533,

573,784, 5,645,860, 5,641,518, 5,711,969, and 5,695,998. The patents listed describe the features of the SIS.

SIS is a natural non-cellular bio-material used to correct various anatomical defects and to treat and stabilize traumatic injuries. (See Cook Biotech: Cook® Online

New Release www.cookgroup.com. ) SIS material is a collagen intercellular material (matrix) made from the submucosa of the small intestine of swine, which fits into the characteristics of the recipient when implanted into human soft tissues. In addition, the SIS material is a natural, three-dimensional, biochemical composition-like intercellular material that is capable of binding to host cells and facilitating tissue reconstruction. · "· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · >> · · · · · · · · · · · · · · · · · · · >> · · · · · · Oasis ™ Wound Dressing Biomaterial (manufactured by Cook Biotech, Bloomington, IN). The Oasis ™ wound cover is produced in single-hole punched sheets. The SIS is easy to use for covering wounds.

In addition to the mucosa beneath the small intestinal mucosa, a portion of the mucosa from other sources may also be used for tissue regeneration. Examples of such sources include the gastric, bladder, digestive, respiratory, or genital mucosa. See U.S. Patent Nos. 6,171,344, 6,099,567 and 5,554,389. In addition, it is known that the porcine subspecies of other origin, such as cattle and sheep, may be suitable for this purpose. In addition, other collagen intercellular agents are known, such as lamina propria and stratum compactum.

At the same time, so-called vacuum joints are known to aid in healing the wound. Vacuum bonding is a bond where a wound closes the wound along its outer perimeter, and creates a vacuum on the surface of the wound during wrapping. Such vacuum bonding accelerates the healing process of chronic wounds. Typically, wound removal from the wound is provided by suction tubes, and the exhaust tubes may also be used to form the vacuum under the cover. If the cover is a more comfortable elastic cover for the patient, a porous topsheet may be provided under this cover to provide a vacuum space. Furthermore, the wound treatment device thus formed may also include a heating unit that also aids in healing the wound. Such vacuum and / or heat treatment joints are described in U.S. Pat. Nos. 6,095,992, 6,080,189, 6,071,304, 5,645,081, 5,636

643, 5 358 494, 5 298 015, 4 969 880, 4 655 754, 4 569 674, 4

U.S. Patent Nos. 382,441 and 4,112,947.

U.S. Pat. No. 5,645,081 discloses a method for regenerating disrupted tissues, thereby exerting a negative pressure on the wound. The negative pressure applied for an appropriate time and to an appropriate degree promotes tissue formation, thereby accelerating the wound closure process. In this solution, an open-cell polyester foam layer covers the wound, one end of an elastic hollow tube is inserted into the foam layer, the other end is connected to a vacuum pump, the foam layer and tubing are covered with an adhesive film adhering to the skin around the wound. it closes tightly so that the vacuum pump is operated under vacuum. According to the document, the negative pressure applied is between 0.1 and 0.99 atmospheres, which may be substantially continuous and only eliminated for the exchange of the bond. In another embodiment, the pressure is not continuous but is applied or eliminated at a given interval, preferably by five minutes.

The subject of vacuum wound treatment and wound healing is the issue of "Wound Treatment Apparatus", registered on 09 August 1999, 09/369 113, with number 09/725 352 of 29 November 2000. \ t "Vacuum Therapy and Cleansing Dressing Forum Wounds" and November 29 - 4, 2000

666, Wound Treatment

U.S. Pat.

The benefits of vacuum binding and the effect of the vacuum on the surface of the chronic wound are discussed in several studies. There are many Russian-language articles that describe the effectiveness of vacuum therapy. For example, the issue of applying a wound healing vacuum is explained by Davydov et al. Khiri., 1988. Sep., "Vacuum therapy in the treatment of acute suppurative diseases and suppurative wound treatment" (hereinafter referred to as the September 1988 article); Davydov et al., Khirurigiia, June 1990, "Pathenogenic mechanism of the effect of vacuum therapy on the wound healing process" (hereinafter referred to as the June 1990 article); and Davydov et al., Vestn. Khir., Nov. 1986, "Vacuum therapy in the treatment of suppurative lactation mastitis" (hereinafter referred to as the November 1986 article).

These Russian articles distinguish wound drainage from vacuum therapy used for healing, and report that vacuum therapy speeds up wound cleansing and faster detoxification than the conventional wound drainage procedure. As described in the November 1986 article, vacuum therapy is applied at 0.8-1.0 atmospheres for twenty minutes during surgery and twice daily thereafter.

A 1.5-3 hour treatment is used with a vacuum of 0.1-0.15 atmospheres. Russian articles teach us how to use negative pressure healing and how the vacuum process can be used to reduce the number of microbes in the wound. The article of June 1990 reports that vacuum therapy has a significant bactericidal effect. The article of June 1990 says that the area around the wound increases blood flow, resulting in more leukocytes reaching the inflammatory foci. In addition, Russian articles also point out that the use of vacuum therapy improves local blood circulation. According to an article in September 1988, blood flow to the wound area is more perfect, which accelerates the regeneration process. The article of June 1990 describes that vacuum therapy facilitates the entry of blood plasma, interstitial fluid and lymph. The article of June 1990 reports that the cellular and non-cellular elements of connective tissues appear twice as fast in the wound treated with vacuum therapy. The benefits of vacuum therapy therapy are therefore well known in the art, several articles and patents are devoted to its development.

It is an object of the present invention to provide a wound dressing that combines the benefits of SIS and vacuum therapy to control and promote fluid flow from the wound surface and into the SIS. It is a further object of the present invention to provide a method for controlling fluid out of the tissue surrounding the wound and introducing it into a wound SIS layer, which results in the healing process being accelerated and the restructuring properties of the SIS being emphasized.

In accordance with the present invention, a structure is formed with the aid of a structure over the SIS and the wound surface, in which a vacuum is created, which causes blood to flow from the wound surface to the SIS. Furthermore, in the method of the invention, the vacuum level and the time of vacuum loading are controlled for optimal blood flow from the wound surface to the SIS.

In preferred embodiments, the wound dressing comprises one

SIS layer, which is placed directly on the wound surface. As stated above, a structure is placed over the SIS layer in the wound management link to provide a vacuum space between the SIS layer and the coating layer on the structure and SIS layer. The cover layer is attached to the patient's skin around the wound to isolate the wound from the outside world. A vacuum source is connected to the wound covering layer in connection with the vacuum space provided with the structure. The vacuum source is used to create a vacuum in the isolated space so as to flow the blood drawn from the wound surface through the SIS, thereby facilitating the healing process. The vacuum level produced by the vacuum pump is sufficient to deliver blood to the SIS layer, for example 125 mmHg. However, it is conceivable that different vacuum pressures will be applied during the various vacuum treatments.

In one embodiment, the spatial structure is a porous or mesh cushion or other structure that is * * in the SIS layer.

cover air leading to cover. Alternatively, the spacing structure is a foam material ring, or it may be the cover layer itself, if it has sufficient stiffness.

Accordingly, the present invention relates to a wound dressing comprising a collagen intercellular material applied to the wound, a wound covering layer that provides an airtight closure around the wound and is connected to a vacuum source and a structure that is a collagen intercellular material and a covering layer. is located between a vacuum space. The collagen intercellular material is preferably comprised of a submucosal layer.

In addition, the present invention relates to a wound treatment bond comprising an SIS layer which can be placed on the wound, and a cover layer providing a vacuum space between the wound, the SIS layer and the inner surface of the cover layer, placed on the wound and SIS layer, the space for a vacuum source. connected.

Another aspect of the present invention is to provide a wound healing process comprising the steps of: providing a wound dressing comprising an SIS layer on the wound, a cover layer on the wound for vacuum over the wound, a structure defining the vacuum space on the wound. Between the SIS layer and the cover layer, and in the vacuum space, a vacuum is created, so that blood can be sucked out of the wound into the SIS layer placed on the wound.

Another aspect of the present invention is to provide a wound healing process by placing an SIS layer on the wound surface, holding a support over the SIS layer, covering the wound, the SIS layer and the supporting structure with a cover layer to define a vacuum space. , the cover layer is connected to a vacuum source and a vacuum is created within the vacuum space.

Another object of the present invention is to provide a wound healing process by applying a collagen intercellular material to the wound surface, creating a vacuum space that is associated with the wound and collagen intercellular material, and creating a vacuum in the vacuum space that is sufficient in size and duration. to withdraw blood from the wound into the collagen intercellular material.

Finally, the present invention provides a wound healing kit comprising a mucosal layer on the wound contact, a porous cushion, and a cover layer forming a closure around the wound and being attached to a vacuum source for its design.

The invention will now be described in detail with reference to the accompanying drawings.

Figure 1 is a cross-sectional view of a scar-free wound and a wound-treatment joint, wherein the bond comprises an SIS layer, a porous cushion or pad and a cover layer that can be connected to a vacuum source by a tube.

Figure 2 is a top plan view of the SIS layer shown in Figure 1 illustrating its perforation.

Figure 3 shows another non-scar-like wound and another wound-treatment joint, wherein the bond comprises an SIS layer, a support structure for forming a vacuum space, a cover layer, and

a vacuum tube placed beneath the cover layer, one end of which is connected to the vacuum space and the other end connected to a vacuum source.

Fig. 4 shows a cross-section of another embodiment of a wound dressing according to the invention placed on a scar-free wound, the binding comprising an SIS layer, an annular structure defining a vacuum space, connected to the vacuum source and placing a cover layer on the structure.

Figure 5 shows another embodiment of the invention, wherein the bond comprises a semi-rigid support structure defining a vacuum space that can be attached to a vacuum source.

1-5. Fig. 1 shows the wound treatment joints 10 for treating a wound-free wound 12; FIG. 1 shows a bond of a small intestinal mucosa (SIS) 14 adjacent to the wound surface 16 of the wound. The bond 10 further comprises a cover layer 18 positioned over the wound 12 and a structure 20, 120, 220 or 320 disposed between the SIS layer 14 and the cover layer 18 to form the vacuum space 22. The cover layer 18 is adhered to the skin 24 of the patient around the wound 12 to provide a closed environment for the wound 12, the SIS 14 layer, and the structure 20, 120, 220 or 320. The joint 10 further comprises means for connecting the vacuum space 22 to a vacuum source 26. Thus, the wound treatment bond combines the benefits of 14 SIS layers and vacuum therapy for faster healing.

- 10 • · · · ·

The SIS layer 14, which is placed directly on the wound surface 16, may be perforated or perforated to prevent fluid accumulation under the 14 SIS layer. Such holes or perforations 28 include, for example, the SIS layer shown in Figure 2. It is believed that the device for punching used for skin transplantation may also be used to punch the 14 SIS layer. In the SIS 14, these holes 28 or perforations allow the blood to leak from the wound 12 into the SIS 14, and to initiate cell formation and tissue growth in the SIS 14 of the 14 SIS layer.

The 14 SIS layer can be created from a single SIS sheet or even from multiple SIS pages. In case the SIS layer contains more SIS pages, the pages can be in any direction relative to each other. In addition, the thickness of the SIS 14 layer in the bond 10 may be any reasonable thickness. It is known that larger sheets can also be formed from the submucosal portion by combining several strips of the submucosal portion. Such a solution is disclosed in U.S. Patent No. 5,711,969. In a preferred embodiment, the SIS layer 14 is adapted to the size of the wound and is adapted to accommodate any complex wound or wound surface due to the elasticity of the formed SIS 14 layer. Furthermore, the SIS used for wound treatment may be in fresh, frozen or lyophilized form. The lyophilized SIS can be used to dry or hydrate before use.

Optionally, a biological adhesive 30 may be applied between the welded wound surface 16 and the SIS layer 14 to securely secure the 14 layer of SIS 14 on the wound surface 16, for example as shown in FIG.

11 is shown in Figure 1. Examples of such biological adhesives include a fibrin sealant. However, any other biological adhesive can be used if it prevents the movement of the 14 SIS layer relative to the wound surface 16.

SIS is generally the submucosal portion of the small intestine of swine, but other parts of the animal, such as beef, sheep and other warm-blooded mammalian intestines, may also be used. In addition, it is known that other parts of the mucosa from different tissues are suitable for tissue reconstruction. Examples of such sources include the gastric, bladder, digestive, respiratory, or genital mucosa. Such mucosal intracellular materials contain highly conserved collagens, glycoproteins, proteoglycans, and glucosaminoglycans. In addition, other collagen intercellular agents that are useful as biological scaffolds are also known. Therefore, although in the preferred embodiment of the present invention SIS was used, other collagen intercellular material may be used for the purpose.

The bond 10 comprises a device for providing a vacuum space 22 between the SIS layer 14 and the cover layer 18. On the one hand, this structure serves as a support for the cover layer 18 and, on the other hand, provides air passages for the wound surface 16 and the SIS 14 layer. In the preferred embodiment shown in Figure 1, this structure is a mesh or porous filler or pad. There are air passages through the cushion 20 (not shown). The cushion 20 is preferably made of a resilient material so that it can conform to any complicated wound or wound surface and be comfortable with the * «»

- 12 • · · ·· ·· «« · «4 · * * •« ♦ · · · · · · · · · · · · · · · · for the patient. Furthermore, the thickness of the structure is chosen such that the vacuum effect is felt in all areas of the wound properly. Preferably, the thickness of the mesh elastic pad 20 is about one to two centimeters. The 20 mesh or porous cushion can be cut larger by the surgeon than the 14 SIS layer, or even larger than 12 wounds.

In the described embodiment, the space between the SIS layer 14 and the cover layer 18 was created using the porous pad 20, but the invention can also be accomplished with another device allowing airflow in the suction effect from the wound to the wound surface 16. As shown in Figure 3, the structure 120 is formed of a gauze, while in the embodiment shown in Figure 4, this structure may be a ring 220 made of a foam material or the like, capable of holding the cover layer 18 at a distance from the SIS 14 layer. . The inner wall 221 of the ring 220 defines an opening in the ring 220. The vacuum space 22 is thus defined by the inner layer 14, the cover layer 18 and the inner wall 221 of the ring 220.

Further, as shown in FIG. 5, for example, the structure may be a rigid or preferably semi-rigid dome 320 supporting the cover layer 18 above the SIS layer 14. The half-rigid dome 320 includes a lower member 322 that fits directly to the patient's skin around the wound, an upper member 324 at a distance from the SIS layer 14, and a central member 326 to support the upper member 324 to 14 SIS layers. The 320 half-rigid dome, as it is in its name, can be dome-shaped. However, the exemplary 20 porous

- 13 * · * ·· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · foam foam, " 18 under the cover layer to the vacuum source 26.

The cover layer 18 of the bond 10 is positioned above the vacuum space providing device, completely enclosing the structure, the 14 SIS layer and the wound 12. The cover layer 18 is attached to the skin of the patient 24 around the wound. The cover layer 18 may be, for example, a thin, transparent, non-porous adhesive sheet which, when adhered to the surface of the skin 24, provides a vacuum-tight closure. Adhesion of the cover layer 18 to the skin 24 is provided by the adhesive 33 in accordance with FIGS. FIGS. Examples of the coating layer include Tegaderm ™ (3M Health Care Ltd., St. Paul, MN). But any other non-porous, impermeable or semi-impermeable material sheet can be used as a cover layer. For the convenience of the patient, it is preferable to use a flexible or semi-flexible cover layer, but a rigid cover such as a glass dome may also be used. When a rigid cover is used, there is no need for a separate structure for the vacuum space, since the rigid cover alone can provide a vacuum space.

In order to facilitate the flow of blood to the wound 12 and the wound surface 16, the vacuum space 22 of the wound treatment joint 10 is connected to the vacuum source 26. The connection between the vacuum space 22 and the vacuum source 26 is provided by a vacuum tube 32. As shown in FIG. 1, the vacuum tube 32 communicates with the vacuum space 22 in association with the cover layer 18. The first end of the 40 vacuum tubes 40 · «*

- 14 • · · * 4

It includes a collar 34 which is connected to the opening formed by the cover layer 18. The second end 42 of the vacuum tube 32 is connected to a vacuum source 26 shown schematically in the figure.

The 3-5. 1 to 3, the vacuum tube 32, for example, is positioned under vacuum cover 18 in the vacuum space 22. The cover layer 18 is sealed around the vacuum tube 32 to provide a perfect vacuum. The vacuum is created by means of a vacuum tube placed in the vacuum space, which is suitable for removing excess wound fluid from the wound. Another type of system for linking the wound covering to the vacuum source is disclosed in U.S. Patent No. 4,969,880. Furthermore, while in Figs. 3 and 4, the first end 40 of the vacuum tube 32 is located in the structure 120 or 220, it is believed that it can also be placed directly on the 14 SIS layer. In addition, the tube 32 may be a Jackson-Pratt type drain tube, which is perforated in a region adjacent to its first end.

Vacuum can be created in the vacuum space 22 for defined periods of time. For example, the vacuum is first used for a time sufficient to draw the blood into the SIS layer, for example at a pressure of 125 mmHg. Different protocols can be envisaged regarding the size of the vacuum and the time of application. The vacuum can also be provided by a perforated tube which, by positioning and shaping, is capable of removing excess wound fluid.

When treating the wound 12, the caregiver first cleans and prepares the wound surface 16. After preparing 16 wound surfaces

- 15 "* * places the bond 10 in the wound by inserting the layer 14 of SIS into the wound 12 in a manner that covers the prepared wound surface 16. THE

It places 20, 120, 220, or 320 structures on the SIS layer 14 to determine the vacuum space, and then places the cover layer 18 over the wound 12, the SIS 14 layer, and the structure 20. The cover layer 18 is connected to the vacuum source 26. Finally, it exerts a sufficient and long-lasting suction effect on the wound to deliver blood from the wound to the 14 SIS layer, optionally, prior to insertion of the 10 bond, to apply a biological adhesive to the wound surface.

The size or duration of the vacuum is selected to facilitate the flow of blood from the wound to the SIS layer. Preferably, the vacuum is between 0.1 and 0.99 atmospheres, preferably between 0.1 and 0.15 atmospheres. In one embodiment, the vacuum is applied substantially continuously until complete recovery. In another embodiment, the vacuum is applied intermittently and the structure and the cover layer are removed when no vacuum is applied. In the case of intermittent treatment, one or two treatments per day are performed for several days. In another embodiment, the suction effect is initiated or terminated at intervals of five minutes.

It is known that the SIS can be incorporated into the wound and restructured to conform to the surrounding tissue. Thus, while using a variable strength and time vacuum, the SIS remains on the surface of the wound during the treatment period. Alternatively, additional SIS layers may be placed on the wound surface as the SIS is incorporated into the wound. The subsequent layers may be smaller pieces at fixed locations, or, since the vacuum facilitates the flow of blood into the SIS layer, there may be pieces corresponding to the total size of the wound surface.

Thus, during the wound treatment process of the present invention, the wound surface is prepared, the bandage is applied to the wound, wherein the bond comprises an SIS layer attached to the wound, a blanket defining a vacuum space above the SIS and the wound, and a vacuum is created in the vacuum space. As a result, blood is drawn from the wound into the SIS layer.

The present invention has been described by way of examples of preferred embodiments;

Claims (1)

  1. within the scope of the claims.
    - 17 Claims
    A wound treatment bond comprising: a collagen intercellular material applied to the wound, and a cover layer that provides a hermetically sealed environment around the wound and which can be attached to a vacuum source.
    The binding of claim 1, wherein the collagen intercellular material is a submucosal layer.
    3. The binding of claim 2 wherein the mucosal layer is an SIS layer.
    The binding of claim 3, wherein the SIS layer comprises one or more SIS sheets.
    The binding of claim 3, wherein the SIS layer is perforated.
    6. The binding of claim 1, wherein the bond further comprises a biological adhesive that fixes the collagen intercellular material between the wound and collagen intercellular material in the wound.
    7. The bond according to claim 6, wherein the adhesive is a fibrin sealant.
    The bond according to claim 1, characterized in that the covering layer has a first surface and a second surface, and there is an adhesive on the first surface for attaching the covering layer to the skin around the wound.
    The bond according to claim 8, characterized in that the cover layer comprises an opening that can be connected to the vacuum source.
    10. The binding of claim 1, further comprising a structure providing a vacuum space positioned between the collagen intercellular material and the coating layer.
    11. The binding of claim 10, wherein the structure is a porous pad in which there are air passages between the cover layer and the collagen intercellular material to determine the vacuum space.
    12. The binding of claim 11, wherein the cushion can be cut to the shape of the wound.
    13. The binding of claim 11, wherein the pad is elastic.
    14. The binding of claim 11, wherein the cushion has a thickness of about 1-2 cm.
    The bond according to claim 10, wherein the structure is a ring wherein the inner wall of the ring defines an opening and the collagen intercellular material, the coating layer, and the inner wall of the ring determine the vacuum space.
    16. The binding of claim 10, wherein the structure is a semi-rigid wall adjacent to the coating layer at a distance from the collagen intercellular material.
    17. The binding of claim 16, wherein the semi-rigid wall comprises a lower member surrounding the patient's wound.
    - adjacent to the skin 19, an upper member located at a distance from the collagen intercellular material, and a middle member, integrating the top and bottom members, to ensure the proper distance of the upper member from the collagen intercellular material.
    18th DIG 16th according to claim 1 binding, with j jury, that the half-rigid wall dome shaped. 19th The First according to claim 1 binding, with characterized in that
    includes tubing to connect the cover layer to the vacuum source.
    20. A method of healing a wound using a wound dressing, characterized in that the binding comprises:
    a collagen layer placed on the wound is a cover layer to cover the wound and collagen layer by forming a vacuum space above them, and vacuuming in a vacuum source in the vacuum space;
    thereby regulating blood a of which a collagen layer to suction. 21. The method of claim 20 process characterized by that the collagen layer SIS layer. 22. The method of claim 21 process characterized by that
    the vacuum is applied at a given time or eliminated to control blood suction from the wound to the SIS layer.
    23. The method of claim 21, wherein the vacuum is maintained at a constant level to control the suction of blood from the wound to the SIS layer.
    24. The method of claim 21, wherein the vacuum used is from about 0.1 to about 0.15 atmospheres.
    - 20 • ···· ·
    25. The method of claim 21, wherein the bond comprises a structure defining the vacuum space between the SIS layer and the cover layer.
    26. The method of claim 25, wherein the structure is a porous cushion in which there are air passages between the coating layer and the collagen intercellular material to determine the vacuum space.
    27. The method of claim 25, wherein the structure is a ring wherein the inner wall of the ring defines an opening and the collagen intercellular material, the coating layer, and the inner wall of the ring define the vacuum space.
    28. A kit for healing a wound comprising:
    a mucosal layer on the wound contact, a porous cushion, and a cover layer capable of hermetically sealing the area of the wound and attached to a vacuum source.
    29. The kit of claim 28, further comprising a vacuum tube.
    30. The kit of claim 29, wherein the mucosal layer is an SIS layer.
    The agent ..
    »R. Binding ZoM Patent », · __ ·« *
    £ 7175-67901 -WAWY ρ 03 023 0 1 / / 2
    FIG
    -s- • «« r í..W JEL,
    FIG. Ί
HU0302301A 2000-05-22 2001-05-15 SIS combination vacuum bandage and bandage wounds such recovery procedure and using HU0302301A2 (en)

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