WO2005102234A2 - Wound contact device - Google Patents

Wound contact device Download PDF

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Publication number
WO2005102234A2
WO2005102234A2 PCT/US2005/008129 US2005008129W WO2005102234A2 WO 2005102234 A2 WO2005102234 A2 WO 2005102234A2 US 2005008129 W US2005008129 W US 2005008129W WO 2005102234 A2 WO2005102234 A2 WO 2005102234A2
Authority
WO
WIPO (PCT)
Prior art keywords
wound
contact elements
permeable
healing
depressions
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2005/008129
Other languages
English (en)
French (fr)
Other versions
WO2005102234A3 (en
Inventor
John R. Boehringer
John Karpowicz
Amitabha Mitra
Christopher L. Radl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Laboratories Inc
Original Assignee
Boehringer Laboratories Inc
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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35061520&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2005102234(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to ES05725347.8T priority Critical patent/ES2460957T3/es
Priority to PL05725347T priority patent/PL1734910T3/pl
Priority to BRPI0509866-1A priority patent/BRPI0509866A/pt
Priority to AU2005235134A priority patent/AU2005235134B2/en
Priority to CA002562691A priority patent/CA2562691A1/en
Application filed by Boehringer Laboratories Inc filed Critical Boehringer Laboratories Inc
Priority to JP2007508349A priority patent/JP4739325B2/ja
Priority to EP05725347.8A priority patent/EP1734910B1/en
Publication of WO2005102234A2 publication Critical patent/WO2005102234A2/en
Publication of WO2005102234A3 publication Critical patent/WO2005102234A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00987—Apparatus or processes for manufacturing non-adhesive dressings or bandages
    • A61F13/00991—Apparatus or processes for manufacturing non-adhesive dressings or bandages for treating webs, e.g. for moisturising, coating, impregnating or applying powder
    • A61F13/00995—Apparatus or processes for manufacturing non-adhesive dressings or bandages for treating webs, e.g. for moisturising, coating, impregnating or applying powder for mechanical treatments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
    • A61F13/01042—Absorbency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
    • A61F13/0283—Apparatus or processes for manufacturing adhesive dressings or bandages for making adhesive or cohesive tape or fabrics therefor, e.g. coating or mechanical treatments
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/915—Constructional details of the pressure distribution manifold
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00217—Wound bandages not adhering to the wound
    • A61F2013/00221—Wound bandages not adhering to the wound biodegradable, non-irritating
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00246—Wound bandages in a special way pervious to air or vapours
    • A61F2013/00251—Wound bandages in a special way pervious to air or vapours with macroscopic openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00246—Wound bandages in a special way pervious to air or vapours
    • A61F2013/00255—Wound bandages in a special way pervious to air or vapours with pores
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/0028—Wound bandages applying of mechanical pressure; passive massage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00314—Wound bandages with surface treatments
    • A61F2013/00327—Wound bandages with surface treatments to create projections or depressions in surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00536—Plasters use for draining or irrigating wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/0054—Plasters use for deep wounds
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00553—Plasters form or structure with detachable parts
    • A61F2013/00561—Plasters form or structure with detachable parts with adhesive connecting means
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00604—Multilayer
    • A61F2013/00608—Multilayer with reinforcing layers
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00855—Plasters pervious to air or vapours
    • A61F2013/00863—Plasters pervious to air or vapours with pores
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61F2013/0091—Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
    • A—HUMAN NECESSITIES
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    • A61F13/00—Bandages or dressings; Absorbent pads
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    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S428/00—Stock material or miscellaneous articles
    • Y10S428/922—Static electricity metal bleed-off metallic stock
    • Y10S428/9335—Product by special process
    • Y10S428/939—Molten or fused coating

Definitions

  • the invention relates to a device and method for treating wounds. More specifically, the present invention relates to a therapeutic wound contact device.
  • Wound healing is a basic reparative process of the human body. It has been known throughout time that dressing wounds with appropriate materials aids the body's natural regenerative process. Historically, such materials have been made from cotton fibers; e.g. gauze.
  • wound healing depends on the interplay of complex mechanisms involving cell proliferation, migration and adhesion coupled with angiogenesis.
  • Application of traditional gauze or other essentially flat materials are essentially sub-optimal with respect to these mechanisms.
  • Wound healing studies In- vitro are carried out in cell culture vehicles that permit cellular function. It is therefore desirable in the practice of wound healing to provide the equivalent of cell culture or a bioreactor system to allow the optimal interplay of cell functions of proliferation, migration and adhesion. Additionally, it is essential to incorporate other bodily functions that encourage the supply of fibronectins, plasma proteins, oxygen, platelets, growth factors, immunochemicals and so forth.
  • the present invention is a wound contact material, a method for making the wound contact material, and a method of treatment employing the wound contact material.
  • a therapeutic device for promoting the healing of a wound in a mammal comprises a permeable substrate or structure having a plurality of depressions formed in a surface thereof, wherein said surface having said depressions is disposed in surface contact with the wound.
  • a therapeutic device for promoting the healing of a wound in a mammal is provided.
  • the device comprises a permeable structure having a plurality of wound surface contact elements disposed between end portions of the structure, and a plurality of voids defined by the contact elements-
  • a therapeutic device for promoting the healing of a wound in a mammal comprising a permeable structure comprising a plurality of fibers coupled to one another having a plurality of wound surface contact elements disposed between end portions of the structure and a plurality of voids defined by the contact elements is provided.
  • a therapeutic device for promoting the healing of a wound in a mammal comprising a polyester felt having a plurality of wound surface contact elements disposed between end portions of the structure and a plurality of voids defined by the contact elements is provided.
  • a method of manufacturing a therapeutic device for promoting the healing of a wound in a mammal comprises the steps of providing a molten substrate material providing a mold defining a plurality of depressions and a plurality of contact elements and applying the molten substrate material to the mold.
  • a method of manufacturing a therapeutic device for promoting the healing of a wound in a mammal comprises the steps of providing a permeable structure and forming a plurality of depressions into a surface of the permeable structure.
  • a method of treating a wound comprises the steps of providing a permeable structure comprising i) a plurality of wound surface contact elements disposed between end portions of the structure, and ii) a plurality of voids defined by the contact elements, and applying the permeable structure to at least one surface of the wound and applying a force to the structure to maintain the structure in intimate contact with the wound surface .
  • Figure 1 is a perspective view of a channeled wound contact dressing according to a first exemplary embodiment of the present invention
  • Figure 2A is a perspective view of a channeled wound contact composite according to a second exemplary embodiment of the present invention
  • Figure 2B is a cross section of the channeled wound contact composite according to the second exemplary embodiment of Figure 2A
  • Figure 3A is a perspective view of a dimpled wound dressing according to a third exemplary embodiment of the present invention
  • Figure 3B is a top view of the dimpled wound dressing illustrated in Figure 3A
  • Figure 3C is a bottom view of the dimpled wound dressing illustrated in Figure
  • Figure 3D is a cross sectional view of the dimpled wound dressing illustrated in Figure 3A
  • Figures 4A, 4B, 4C are illustrations of the dimpled wound dressing of Figure 3A in use
  • Figure 5A is a perspective view of an irregular wound contact dressing according to a fourth exemplary embodiment of the present invention
  • Figure 5B is a cross sectional view of the irregular
  • a wound dressing with a discontinuous contact layer surface has the advantages of promoting tissue growth with wound surface contact elements and permitting tissue growth by providing void volume for the subsequent tissue growth within the discontinuities.
  • the structure of the contact material is sufficiently physically rugged to resist flattening when forces required to press the material against the wound surface are applied to the material. It is desirable for the material to retain its structure when exposed to aqueous or other bodily fluids. Many traditional dressing materials soften as they moisten so that their geometry changes.
  • the contact layer is permeable, permitting the underlying wound to breathe and allowing for fluids to be drawn from the wound. The contact layer should not be too absorbent as this might result in a loss of structure.
  • the layer is comprised of base materials that are resistant to change in the presence of moisture and aqueous liquids.
  • the extent of the voids remaining above the wound surface is preferably at least 0.1 mm when the structure is pressed against the surface of the wound.
  • the width of the voids, as defined by contact elements adjacent the voids, is preferably greater than 0.1 mm. A more preferred width is between about .5 to 10 mm and a more preferred height is between about .2 to 5 mm.
  • Wound healing is recognized as a complex process. When a wound contact material as described is forced against a wound surface, a number of biological processes are believed to occur. Mechanical stress is applied to the underlying tissue.
  • a fibrous substrate or structure has all the flexibilities provided by the textile arts. Fibrous textiles can be formed into a structure for the invention by a number of the methods known in the art. Among these methods are knitting, weaving, embroidering, braiding, felting, spunbonding, meltblowing, and meltspinning.
  • Each of these methods can be further adapted to produce a material whose structure matches that of the present invention.
  • the desired structure can be imparted during production of the structure by, for example, applying molten material directly to a mold as in meltblowing.
  • the structure can be formed by working a formed structure after production by, for example, heat stamping or vacuum forming.
  • fibers can be mixed with an adhesive and sprayed onto a textured surface.
  • the versatility of fibrous textiles also extends to their easy adaptation to composite applications. Individual fiber materials may be varied to optimize a physical parameter such as rigidity or flexibility. Individual fiber materials can also be selected for their known ability to assist in wound healing . Examples of such fiber materials are calcium alginate, and collagen.
  • fibers may be treated with known wound healing agents such as hyaluronic acid or antimicrobial silver.
  • wound healing agents such as hyaluronic acid or antimicrobial silver.
  • the ratio of the fiber materials can be varied to suit the requirements of the wound. According to one desirable aspect of the invention, different fibers with various wound healing properties may be added as desired.
  • FIG. 1 An exemplary embodiment of the present invention is illustrated in Figure 1. As shown in Figure 1, channeled wound dressing 100 is comprised of a generally conformable polyester felt material 102.
  • polyester textile such as a knit, weave, or braid may also be suitable for most applications.
  • Polyolefins such as polyethylene or polypropylene, and polyamides, such as nylon, with similar physical properties are also contemplated. Creep resistance, as exhibited by polyester, is particularly desirable.
  • Void channels 104 are cut into felt material 102 to provide a discontinuity that promotes the upward growth of new tissue.
  • the channeled wound dressing 100 is pressed against a wound in intimate contact with injured tissue.
  • a force of 0.1 psi or more is desirably applied to the contact layer to press the contact elements against the surface of the wound. Wound contact elements 106 are thus in intimate contact with injured tissue.
  • FIGS 2A and 2B illustrate a wound dressing composite 200 comprised of channeled dressing 100 and a vapor permeable adhesive backed sheet 202.
  • Adhesive backed vapor permeable sheets in general, are known in the art and are believed to contribute to wound healing by maintaining a moisture level that is optimal for some wounds.
  • dressing composite 200 is placed onto the surface of the wound with its channeled dressing 100 portion in contact with the wound.
  • Adhesive sheet 202 covers channeled dressing 100 and adheres to skin adjacent the wound.
  • Composite 200 offers the advantages of channeled dressing 100. Additionally, adhesive sheet 202 secures composite 200 and protects the wound from bacteria, etc. while allowing for the transmission of moisture vapor.
  • FIGs 3A, 3B, 3C, and 3D Another desirable embodiment of the present invention is illustrated in Figures 3A, 3B, 3C, and 3D.
  • the substrate or structure for dimpled wound dressing 300 can be constructed from similar materials and production methods employed for channeled dressing 100.
  • Fig 3A depicts a perspective view of dimpled dressing 300 with contact surface 320 on top.
  • Figure 3D shows a cross section of the dimpled dressing 300 which best illustrates the plurality of contact elements 322 and dimple voids 330.
  • the total dimple void area comprises at least about 25% of the total dressing area. More preferably, the total dimple void area comprises at least about 50% of the total dressing area.
  • Dimple voids 330 are partially defined by sidewalls 332.
  • Sidewalls 332 are partially responsible for providing rigidity necessary to resist compaction of dimple dressing 300.
  • Contact elements are preferably constructed to provide an arcuate contact surface. In a preferred embodiment, the radius of contact is between about 0.1 mm to 1 mm.
  • Dimple voids 330 can be formed in a variety of regular or irregular shapes. Preferably, dimple voids are constructed so that they are not “undercut” such that each aperture circumference is smaller than the corresponding inner void circumference.
  • An "undercut” or reticulated void structure can cause tissue disruption when the dressing 300 is removed because any tissue that has grown into the void may be torn away when the material is removed from the wound.
  • a base material for dressing 300 is Masterflo RTM from manufactured by BBA group of Wakefield, MA.
  • the base material has a thickness of about 1.0 mm.
  • Dimple voids 330 are heat stamped in to the base material having a depth of about .75 mm and a diameter of about 2 mm. Because the contact layer is generally replaced every few days it is important to account for the possibility of alignment of newly formed tissue with the voids of a new contact layer.
  • dimple voids 330 can be arranged randomly so that they don't line up with the new tissue growth after each dressing change, 2) different contact layers with different diameter dimples may be provided, or 3) a different spacing of the dimples can be used every time the material is changed.
  • Figures 3B and 3C illustrate the corresponding top and bottom views, respectively, of dimpled dressing 300.
  • One variation of this embodiment is also contemplated having dimple voids 330 and/or contact elements 322 disposed on both the top and bottom of dimpled dressing 300.
  • dimple voids 330 can be partially filled with therapeutic substances.
  • antiseptic substances might be placed in voids 330 for treating infected wounds.
  • biologic healing agents could be delivered in the voids to improve the rate of new tissue formation.
  • the layer of dressing 300 could have a different function on each side. For example, one side of dressing 300 could be optimized for the growth of new tissue, while the other side could be optimized for the delivery of anti-microbial agents, for example.
  • FIG. 4A shows a wound surface 400.
  • wound surface 400 may represent the majority of a shallow surface wound or a small interior portion of a deep tissue wound.
  • Figure 4B shows application of dimpled dressing 300 to wound surface 400 and corresponding tissue growth 410 within dimple voids 330.
  • Figure 4C removal of dimpled dressing 300 leaving tissue growth 410 is illustrated in Figure 4C.
  • FIGs 5A and 5B illustrate another embodiment of the present invention; a rough irregular dressing 500.
  • Figure 5A depicts how irregular dressing 500 has irregular voids 510 and irregular contact elements 520 acting as "hook-like" members that are able to contact and stick to necrotic tissue when the substrate is placed in the wound.
  • necrotic tissue is stuck to hook like protrusions 520 and is thus removed from the wound. Removal of the substrate debrides the wound. Removal of necrotic tissue is an important part of healing wounds.
  • the substrate of dressing 500 may be made from polyester felt or batting. In one exemplary embodiment, the felt is singed with hot air so that a percentage of the fibers melt to form a textured surface with a number of hook like elements 520.
  • Another suitable configuration can be the hook material such as that used with hook and loop fabric.
  • the wound may still be considered infected and can be treated with the substrate including antimicrobial silver, for example, which is useful in killing bacteria, while the substrate and method of use facilitate the growth of new tissue.
  • the phase of wound healing where new tissue is forming is generally referred to as the proliferative phase.
  • a substrate without antimicrobial silver and optionally with the addition of growth enhancing materials is used to facilitate the continued proliferation of new cells and tissue.
  • Figure 5B shows the random cross section of irregular dressing 500.
  • the roughened surface of irregular dressing 500 can be formed by passing a suitable substrate under convective heat at or about the melting point of the substrate's component material.
  • polyester materials typically melt in a range from about 250 degrees Celsius to about 290 degrees Celsius.
  • a polyester felt material passed briefly under a convective heat source operating in this range will experience surface melting and subsequent fusing of the polyester strands at its surface.
  • the degree of surface melting can be controlled with temperature and exposure time to yield a surface of desired roughness exhibiting irregular voids 510 and irregular contact elements.
  • irregular dressing 500 is illustrated as having only one roughened surface the invention is not so limited in that both upper and lower surfaces may be similarly roughened.
  • treatment with the present wound dressing invention comprises forcing the inventive dressing into intimate contact with the wound surface.
  • the force should be at least 0.1 psi.
  • Various methods and systems for maintaining this intimate contact are contemplated. These methods and systems may include: applying an adhesive film over the inventive dressing and adjacent the wound surface; wrapping a bandage over the dressing and around the injured area; and securing a balloon or other inflatable bladder to the structure and inflating the bladder with air or a liquid.
  • the application of pressure to the bladder is provided intermittently.
  • a conformable seal may be placed over the wound and contact structure, a rigid seal is then secured over the wound, contact structure imparting a force on the contact structure.
  • a pressure is then applied between the rigid seal and the flexible seal forcing the contact structure against the wound surface.
  • the intimate contact may be augmented by sealing the wound area with a conformable cover and applying suction.
  • dimpled wound dressing 300 is particularly well-adapted for this application.
  • the range of suction levels is between .25 PSI and 5 psi.
  • the suction use can be further improved by applying a wound packing material to the back of the dressing.
  • a wound packing material is described in U.S. Provisional Patent Application Number 60/554,158, filed on March 18, 2004.
  • Case Study 1 Patient A is a 70 year old male with a Stage IV decubitus ulcer on the right hip with significant undermining.
  • the contact structure of the present invention was applied to the wound and an adhesive film was placed over the wound and the contact structure.
  • a suction of 1.1 psi was applied beneath the adhesive film to impart a force upon the contact structure.
  • the suction was maintained generally continuously.
  • the suction force was generally applied for about half of the day and the force of the bandage wrap was maintained for the remainder of the day.
  • the bandage wrap was solely used to impart the force.
  • a suction of between 1 and 2 psi was used.
  • new tissue had grown over the exposed hardware.
  • the wound area was reduced from to 50 square cm to 28 square cm.

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  • Health & Medical Sciences (AREA)
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PCT/US2005/008129 2004-04-13 2005-03-10 Wound contact device Ceased WO2005102234A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP05725347.8A EP1734910B1 (en) 2004-04-13 2005-03-10 Wound contact device
PL05725347T PL1734910T3 (pl) 2004-04-13 2005-03-10 Urządzenie do kontaktu z raną
BRPI0509866-1A BRPI0509866A (pt) 2004-04-13 2005-03-10 dispositivo terapêutico para promover a cicatrização de uma ferida em um mamìfero, método de fabricação do mesmo, e, método de tratamento de uma ferida
AU2005235134A AU2005235134B2 (en) 2004-04-13 2005-03-10 Wound contact device
CA002562691A CA2562691A1 (en) 2004-04-13 2005-03-10 Wound contact device
ES05725347.8T ES2460957T3 (es) 2004-04-13 2005-03-10 Dispositivo de contacto con heridas
JP2007508349A JP4739325B2 (ja) 2004-04-13 2005-03-10 創傷接触装置

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US56174504P 2004-04-13 2004-04-13
US60/561,745 2004-04-13
US10/982,346 US7884258B2 (en) 2004-04-13 2004-11-05 Wound contact device
US10/982,346 2004-11-05

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US20140228790A1 (en) 2014-08-14
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US20090287129A1 (en) 2009-11-19
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US8710290B2 (en) 2014-04-29
US7884258B2 (en) 2011-02-08
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EP1734910A2 (en) 2006-12-27
WO2005102234A3 (en) 2006-08-24

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