WO2024062325A1 - Pansement doté d'un dispositif de fermeture intégré - Google Patents

Pansement doté d'un dispositif de fermeture intégré Download PDF

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Publication number
WO2024062325A1
WO2024062325A1 PCT/IB2023/058879 IB2023058879W WO2024062325A1 WO 2024062325 A1 WO2024062325 A1 WO 2024062325A1 IB 2023058879 W IB2023058879 W IB 2023058879W WO 2024062325 A1 WO2024062325 A1 WO 2024062325A1
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WO
WIPO (PCT)
Prior art keywords
closure device
mesh
tissue site
adhesive layer
nitinol
Prior art date
Application number
PCT/IB2023/058879
Other languages
English (en)
Inventor
Jonathan REHBEIN
Christopher J. Carroll
Shervin JAHANIAN
Luke Perkins
Original Assignee
Solventum Intellectual Properties Company
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
Application filed by Solventum Intellectual Properties Company filed Critical Solventum Intellectual Properties Company
Publication of WO2024062325A1 publication Critical patent/WO2024062325A1/fr

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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
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • 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
    • 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
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
    • 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
    • A61F13/0289—Apparatus or processes for manufacturing adhesive dressings or bandages manufacturing of adhesive dressings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/58—Adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61F2013/00902—Plasters containing means
    • A61F2013/00936—Plasters containing means metal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/16—Materials with shape-memory or superelastic properties

Definitions

  • the invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but without limitation, to a dressing having an integral closure device.
  • tissue site Whether the etiology of a tissue site, or damaged area of tissue, is trauma, surgery, or another cause, proper care of the tissue site is important to the outcome.
  • an opening on the epidermis may be closed using sutures, staples, clips, and other mechanical devices to allow the skin to be held and pulled. Such devices often cause puncture wounds or other wounds.
  • tremendous pressure may be placed on the closure device, and the pressure may cause harm to the tissue site.
  • tissue site is an area without an opening in the epidermis
  • proper care can also improve a rate of healing of the tissue site.
  • an appropriate force such as compression, apposition, or distention force can help control blood flow to the tissue site to reduce swelling or encourage growth factors and re-building of tissue.
  • Current devices used to apply these forces may require cumbersome systems and/or rely on materials that may be unable to apply a consistent force to the area over time.
  • an apparatus for generating a force at a tissue site can include a closure device formed from a super-elastic material.
  • the closure device can have a first side, a second side, a perimeter portion, and a center portion disposed inboard of the perimeter portion, the center portion configured to exert the force at the tissue site.
  • the apparatus can also include an adhesive layer disposed adjacent to the first side of the closure device, and atop cap layer disposed adjacent and coupled to the second side of the closure device.
  • a dressing for covering a tissue site is described.
  • the dressing can include a mesh having a center portion and a perimeter portion.
  • the center portion can be configured to generate distension in the tissue site.
  • the dressing can also include an adhesive layer disposed adjacent to the mesh, and a film layer disposed adjacent to the mesh, the adhesive layer adhering the film layer to the mesh.
  • a nitinol mesh can be provided.
  • the nitinol mesh can be constrained in a mold.
  • the mold can have a convex portion and a concave mating portion.
  • the nitinol mesh can be heated, and the nitinol mesh can be removed from the mold.
  • a double-sided adhesive can be laminated to the nitinol mesh, and the nitinol mesh can be encapsulated with a top cover.
  • Figure 1 is a perspective view of an example embodiment of a plurality of apparatuses disposed at a tissue site in accordance with some embodiments;
  • Figure 2 is a sectional view of a cover taken along line 2 — 2 of Figure 1 and illustrating additional features that may be associated with some embodiments;
  • Figure 3 is a sectional view of another example of the cover taken along line 2 — 2 of Figure 1 and illustrating additional features that may be associated with some embodiments;
  • Figure 4 is a schematic view of the cover having a closure device during the process of applying the cover in accordance with some embodiments
  • Figure 5 is a schematic view of the cover having the closure device during the process of applying the cover in accordance with some embodiments
  • Figure 6 is a schematic view of the cover having the closure device during the process of applying the cover in accordance with some embodiments
  • Figure 7 is a sectional view of another cover having another closure device that may be associated with some embodiments.
  • Figure 8 is a perspective view illustrating the cover of Figure 7 disposed at the tissue site
  • Figure 9 is a sectional view of the cover of Figure 7 taken along line 9 — 9 of Figure 8;
  • Figure 10 is a plan view of the tissue site having a plurality of closure devices disposed across an incision of the tissue site in accordance with some embodiments.
  • FIG 11 is a plan view of the tissue site after a plurality of the closure devices disposed at the tissue site. DESCRIPTION OF EXAMPLE EMBODIMENTS
  • tissue site in this context broadly refers to a wound, defect, or other treatment target located on or within tissue, including, but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments.
  • a wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partialthickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example.
  • tissue site may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue.
  • a tissue site may be a target site for growth of additional tissue that may be harvested and transplanted.
  • FIG 1 is a perspective view of an example embodiment of a plurality of apparatuses having an integral closure device disposed at a tissue site 102.
  • Each apparatus can provide a force at a tissue site in accordance with this specification.
  • each apparatus may comprise a cover 104.
  • the cover 104 may provide a bacterial barrier and protection from physical trauma.
  • the cover 104 may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment.
  • the cover 104 may comprise or consist of, for example, an elastomeric film or membrane that can provide a seal adequate to maintain a negative pressure at a tissue site for a given negative-pressure source.
  • the cover 104 may have a high moisture-vapor transmission rate (MVTR) in some applications.
  • MVTR moisture-vapor transmission rate
  • the MVTR may be at least 250 grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at 38°C and 10% relative humidity (RH). In some embodiments, an MVTR up to 5,000 grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.
  • the cover 104 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. Such drapes typically have a thickness in the range of 25-50 microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained.
  • An attachment device may be used to attach the cover 104 to an attachment surface, such as undamaged epidermis, a gasket, or another cover. The attachment device may take many forms.
  • the cover 104 may be placed within, over, on, or otherwise proximate to the tissue site 102. If the tissue site 102 includes an incision 106 or other opening in tissue, the cover 104 may be placed over or across the incision. In other embodiments, the cover 104 may overlay the entire incision 106. In some embodiments, each cover 104 may overlay a portion of the incision 106. For example, more than one cover may be disposed along a length of the incision 106. The cover 104 may be sealed to an attachment surface near the incision 106. For example, the cover 104 may be sealed to undamaged epidermis peripheral to the incision 106. Application of the cover 104 to the tissue site 102 may cause the cover 104 to exert a force on the tissue site 102. In some embodiments, the cover 104 may draw edges of the incision 106 toward each other, urging the incision 106 to close.
  • Figure 2 is a sectional view of the cover 104 taken along line 2 — 2 of Figure 1 and illustrating additional features that may be associated with some embodiments.
  • the cover 104 can include a closure device 202, an adhesive layer 204, and a top cap layer 206.
  • the closure device 202 can be disposed between the adhesive layer 204 and the top cap layer 206.
  • the top cap layer 206 and the adhesive layer 204 can encapsulate or surround the closure device 202.
  • the closure device 202 can be a mesh.
  • the mesh can comprise a plurality of strands 208 formed from threads, fibers, or wires.
  • the mesh of the closure device 202 can be formed by interweaving the plurality of strands 208.
  • a first plurality of strands 208 may be positioned perpendicular to a second plurality of strands 208.
  • the strands 208 may be positioned at non-perpendicular angles to each other.
  • the strands 208 may be woven to form a mesh or net.
  • the plurality of strands 208 can overlay each other without being woven.
  • the strands 208 may have a pitch between about 6 mm and about 25 mm.
  • the strands 208 may have an average effective diameter between about 0.1 millimeters (mm) and about 1 mm.
  • the closure device 202 can be formed from a super-elastic material.
  • the strands 208 can be formed from a super-elastic material.
  • the super-elastic material is biocompatible, non-ferromagnetic, and MR-conditional.
  • the closure device 202 can generate compressive, appositional, and/or distention forces.
  • the closure device 202 can be tuned. The closure device 202 may have two variables that can be tuned.
  • the final shape of the closure device 202 in its austenite state can be tuned.
  • the temperature at which the closure device 202 returns to its austenite state can be tuned.
  • the transformation temperature can be tuned slightly via variations in composition. For example, a ratio of nickel versus titanium or the presence of other trace metals in the alloy can change the austenite state.
  • the temperature can be tuned even further via heat treatment processes.
  • the variables used in heat treating the closure device 202 include duration and temperature of the heat treatment processes.
  • the transformation temperature would be equal or less than body heat (37°C) or at room temperature (20°C).
  • the closure device 202 may retain elasticity overtime.
  • the super-elastic material may be a nickel-titanium alloy, such as nitinol.
  • Nitinol may have properties related to its martensite-austenite transformation and a selectable transition temperature allowing the alloy to have shape-memory properties in response to a particular range of temperatures.
  • An alloy having shape-memory properties can be deformed when cold but return to its pre-deformed shape in response to heat.
  • the nitinol can be heat treated to set a transition temperature for the nitinol.
  • the closure device 202 can have a martensite-austenite transition temperature lower than about 20 degrees Celsius, permitting the closure device 202 to exhibit shape-memory properties at room temperatures. In other embodiments, the closure device 202 can have a martensite austenite transition temperature at about 34 degrees Celsius, permitting the closure device 202 to exhibit shape-memory properties in response to body heat. In other embodiments, the closure device 202 can have a martensite austenite transition temperature at about 100 degrees Celsius, permitting the closure device 202 to exhibit shape-memory properties in response to an external heat source.
  • Nitinol can have a large elastic range and can deform around eight times more than ordinary spring steel while still returning to its original shape.
  • Nitinol may have an elastic modulus for austenite nitinol between about 75 gigapascals (GPa) and about 83 GPa.
  • Nitinol may have an elastic strain for austenite nitinol of about 10%.
  • steel may have an elastic modulus between about 193 GPa and about 210 GPa and an elastic strain of about 1%.
  • Nitinol can have a relatively flat force or stress over a wide range of deformation or strain, allowing for a known force to be applied across an incision, regardless of how much the user pre-stressed the dressing.
  • the closure device 202 may exert a force between about 0 kilopascals and about 13.8 kilopascals. In other embodiments, the closure device 202 may exert larger forces selected for the particular therapy of the tissue site.
  • the adhesive layer 204 can be an attachment device.
  • An attachment device may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover 104 to epidermis at the tissue site 102.
  • some or all of the cover 104 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks.
  • Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel, as previously described.
  • the adhesive layer 204 can comprise a high-tack adhesive. In some embodiments, the adhesive layer 204 can comprise a skin friendly adhesive. In some embodiments, the adhesive layer 204 may be a single-sided adhesive. In some embodiments, the adhesive layer 204 can comprise a 3M 2484 GSA or a Tegaderm acrylic adhesive. For example, the adhesive layer 204 can have an adhesion to low density polyethylene at 180 degrees of about 430 g/25 mm width or 2.8N/25.4 mm.
  • the top cap layer 206 may be a film layer.
  • the top cap layer 206 may comprise, for example, one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers.
  • PU polyurethane
  • PU polyurethane
  • cellulosics such as hydrophilic polyurethane
  • the top cap layer 206 may comprise INSPIRE 2301 having an MVTR (upright cup technique) of 2600 g/m2/24 hours and a thickness of about 30 microns.
  • the top cap layer 206 may also be an adhesive or an attachment device.
  • the top cap layer 206 may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover 104 to epidermis around a tissue site.
  • some or all of the cover 104 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks.
  • Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel, as previously described.
  • the top cap layer 206 may be a high-tack adhesive. In some embodiments, the top cap layer 206 can comprise a skin friendly adhesive. In some embodiments, the top cap layer 206 may be a single-sided adhesive. In some embodiments, the top cap layer 206 can comprise a 3M 2484 GSA or a Tegaderm acrylic adhesive.
  • the closure device 202 can be laminated between the top cap layer 206 and the adhesive layer 204.
  • the top cap layer 206 may have an adhesive surface configured to be positioned adjacent to the closure device 202.
  • the adhesive surface of the top cap layer 206 may couple to the closure device 202, securing the closure device 202 to the top cap layer 206.
  • the adhesive layer 204 can be positioned adjacent to the closure device 202 opposite the top cap layer 206.
  • the adhesive layer 204 may be coupled to the closure device 202 and the top cap layer 206, encapsulating or surrounding the closure device 202 between the adhesive layer 204 and the top cap layer 206.
  • the adhesive layer 205 may be a double-sided adhesive.
  • the adherent surface adjacent to the closure device 202 may couple the adhesive layer 204 to the closure device 202 and the top cap layer 206.
  • the adhesive layer 204 may be a single-sided adhesive.
  • the surface adjacent to the closure device 202 may be non-adherent, and the adherent surface of the top cap layer 206 may also adhere to the adhesive layer 204 through the closure device 202.
  • the top cap layer 206 may be welded to the adhesive layer 204 about a perimeter of the top cap layer 206 and the adhesive layer 204.
  • the cover 104 can be stretched across the tissue site 102, such as an incision.
  • the closure device 202 may be deformed.
  • the closure device 202 may be deformed or stretched in a direction perpendicular to the incision 106 of the tissue site 102.
  • the force deforming the closure device 202 may be released, and the super-elastic properties of the closure device 202, such as the nitinol mesh, can help pull the incision 106 of the tissue site 102 closed.
  • Figure 3 is a sectional view of another example of the cover 104 taken along line 2 — 2 of Figure 1 and illustrating additional features that may be associated with some embodiments.
  • the closure device 202 can comprise a spring or a nitinol spring.
  • the closure device 202 can be laminated between the top cap layer 206 and the adhesive layer 204.
  • the top cap layer 206 may be a polyurethane film configured to be positioned adjacent to the closure device 202.
  • the adhesive layer 204 can be positioned adjacent to the closure device 2020 opposite the top cap layer 206.
  • the adhesive layer 204 may be coupled to the closure device 202 and the top cap layer 206, encapsulating or surrounding the closure device 202 between the adhesive layer 204 and the top cap layer 206.
  • the adhesive layer 205 may be a double-sided adhesive.
  • the adherent surface adjacent to the closure device 202 may couple the adhesive layer 204 to the closure device 202 and the top cap layer 206.
  • the closure device 202 can comprise a beam 302 having a first end 304 and a second end 306.
  • a first arm 308 can be coupled to the first end 304, and a second arm 310 can be coupled to the second end 306.
  • the first arm 308 may be a rod having a first end and a second end opposite the first end.
  • the first arm 308 may have a shaft extending between the first end and the second end.
  • the first end of the first arm 308 may be coupled to the first end 304 of the beam 302.
  • the first arm 308 may extend from the beam 302.
  • the second end of the first arm 308 may be closer to a centerline of the beam 302 than the first end.
  • the first arm 308 may form an angle 316 with the beam 302 having the first end 304 as a vertex of the angle 316.
  • the angle 316 may be less than about 90 degrees. In some embodiments, the angle 316 may be between about 30 degrees and about 60 degrees, and preferably about 45 degrees.
  • the second arm 310 may be a rod having a first end and a second end opposite the first end.
  • the second arm 310 may have a shaft extending between the first end and the second end.
  • the first end of the second arm 310 may be coupled to the second end 306 of the beam 302.
  • the second arm 310 may extend from the beam 302.
  • the second end of the second arm 310 may be closer to a centerline of the beam 302 than the first end.
  • the second arm 310 may form an angle 318 with the beam 302 having the second end 306 as a vertex of the angle 318.
  • the angle 318 may be less than about 90 degrees.
  • the angle 318 may be between about 30 degrees and about 60 degrees, and preferably about 45 degrees.
  • the closure device 202 may further include a first anchor 312 and a second anchor 314.
  • the first anchor 312 may be a beam or rod having a first end 320 and a second end 322 opposite the first end 320.
  • the first anchor 312 may have a shaft extending between the first end 320 and the second end 322.
  • the first end 320 of the first anchor 312 may be coupled to the second end of the first arm 308.
  • the first anchor 312 may extend from the first arm 308 away from the beam 302.
  • the first anchor 312 may be parallel to the beam 302.
  • the second end 322 of the first anchor 312 may be further from the centerline of the beam 302 than the first end 320.
  • the first anchor 312 may form an angle 324 with the first arm 308 having the first end 320 as a vertex of the angle 324.
  • the angle 324 may be less than about 90 degrees. In some embodiments, the angle 324 may be between about 30 degrees and about 60 degrees, and preferably about 45 degrees.
  • the second anchor 314 may be a beam or rod having a first end 326 and a second end 328 opposite the first end 326.
  • the second anchor 314 may have a shaft extending between the first end 326 and the second end 328.
  • the first end 326 of the second anchor 314 may be coupled to the second end of the second arm 310.
  • the second anchor 314 may extend from the second arm 310 away from the beam 302.
  • the second anchor 314 may be parallel to the beam 302.
  • the second end 328 of the second anchor 314 may be further from the centerline of the beam 302 than the first end 326.
  • the second anchor 314 may form an angle 330 with the second arm 310 having the first end 326 as a vertex of the angle 330.
  • the angle 330 may be less than about 90 degrees. In some embodiments, the angle 330 may be between about 30 degrees and about 60 degrees, and preferably about 45 degrees.
  • FIG 4 is a schematic view of the cover 104 having the closure device 202 during the process of applying the cover 104 in accordance with some embodiments.
  • the cover 104 can be stretched across the tissue site 102, such as the incision 106 of the tissue site 102.
  • the closure device 202 may be deformed.
  • the first anchor 312 and the second anchor 314 may be pulled in opposite directions. Pulling the first anchor 312 and the second anchor 314 in opposite directions can cause the angle 316, the angle 318, the angle 324, and the angle 330 to increase as the first end 320 and the first end 326 move away from each other.
  • FIG. 5 is a schematic view of the cover 104 having the closure device 202 during the process of applying the cover 104 in accordance with some embodiments.
  • the first anchor 312 may be secured on one side of the incision 106 by the adhesive layer 204.
  • the closure device 202 may be further deformed.
  • the second anchor 314 may be moved further away from the first anchor 312.
  • the second anchor 314 may be secured to the tissue site 102 on an opposite side of the incision 106 from the first anchor 312.
  • the adhesive layer 204 may secure the second anchor 314 to the tissue site 102.
  • FIG. 6 is a schematic view of the cover 104 having the closure device 202 during the process of applying the cover 104 in accordance with some embodiments.
  • the force deforming the closure device 202 may be released.
  • the closure device 202 can be urged to the original shape of the closure device 202.
  • the closure device 202 is formed from nitinol, the super-elastic properties of the nitinol can cause the first end 326 and the first end 320 to move toward each other, urging the angle 316, the angle 318, the angle 324, and the angle 330 toward their original measurement.
  • the force of the nitinol urging the angle 316, the angle 318, the angle 324, and the angle 330 toward their original measurement can exert a force pushing edges of the incision 106 of the tissue site 102 toward each other to close the incision 106 of the tissue site 102.
  • Figure 7 is a sectional view of another cover 104 having another closure device 202 that may be associated with some embodiments.
  • the cover 104 may include a fluid storage device 702.
  • the fluid storage device 702 may be disposed between the closure device 202 and the adhesive layer 204.
  • the fluid storage device 702 may be disposed between the closure device 202 and the top cap layer 206.
  • the closure device 202 may comprise a mesh having a preformed shape.
  • the closure device 202 may have a center portion 708 and a perimeter portion 710.
  • the perimeter portion 710 may surrounding the center portion 708.
  • the center portion 708 may have a concave side 704 and a convex side 706.
  • the concave side 704 may be disposed proximate to the adhesive layer 204, and the convex side may be disposed proximate to the top cap layer 206.
  • the concave side 704 may have a radius of curvature between about 0 mm and about 10 mm.
  • the perimeter portion 710 may be substantially flat and have a width from the union with the center portion between about 2 centimeters (cm) and about 3 cm.
  • the concave side 704 and the convex side 706 can be formed by constraining the mesh of the closure device 202 in a mold.
  • the mold can have the desired shape for the concave side 704 and the convex side 706.
  • the mesh can be heat treated.
  • the mesh can be heated in a salt bath or a furnace to between about 500 degrees Celsius and about 550 degrees Celsius.
  • the mesh can retain the shape of the mold following the heat treatment process giving the closure device 202 the concave side 704 and the convex side 706.
  • the fluid storage device 702 may be an absorbent that stores, or immobilizes, the liquid from a tissue site.
  • the absorbent may be any substance capable of storing a liquid, such as exudate.
  • the absorbent may form a chemical bond with exudate from the tissue site.
  • Non-limiting examples of the absorbent include super absorbent fiber/particulates, hydrofibre, sodium carboxymethyl cellulose, and/or alginates.
  • the absorbent may be formed of a superabsorbent polymer (SAP).
  • SAPs superabsorbent polymer
  • SAPs can absorb and retain large quantities of liquid, and in particular water. SAPs may be used to hold and stabilize or solidify wound fluids.
  • the SAPs used to form the absorbent may be of the type often referred to as “hydrogels,” “super-absorbents,” or “hydrocolloids.”
  • the SAPs When disposed within a dressing, the SAPs may be formed into fibers or spheres to manifold reduced pressure until the SAPs become saturated. Spaces or voids between the fibers or spheres may allow a reduced pressure that is applied to a dressing to be transferred within and through the absorbent.
  • fibers of the absorbent may be either woven or non-woven.
  • the absorbent may comprise a substrate in which the SAPs may be dispersed as pellets throughout and/or embedded as a sheet-like layer within the substrate.
  • the SAPs may be formed in several ways, for example, by gel polymerization, solution polymerization, or suspension polymerization.
  • Gel polymerization may involve blending of acrylic acid, water, cross-linking agents, and ultraviolet (UV) initiator chemicals. The blended mixture may be placed into a reactor where the mixture is exposed to UV light to cause crosslinking reactions that form the SAP. The mixture may be dried and shredded before subsequent packaging and/or distribution.
  • Solution polymerization may involve a water-based monomer solution that produces a mass of reactant polymerized gel. The monomer solution may undergo an exothermic reaction that drives the crosslinking of the monomers. Following the crosslinking process, the reactant polymer gel may be chopped, dried, and ground to its final granule size.
  • Suspension polymerization may involve a waterbased reactant suspended in a hydrocarbon-based solvent. However, the suspension polymerization process must be tightly controlled and is not often used.
  • SAPs absorb liquids by bonding with water molecules through hydrogen bonding. Hydrogen bonding involves the interaction of a polar hydrogen atom with an electronegative atom. As a result, SAPs absorb water based on the ability of the hydrogen atoms in each water molecule to bond with the hydrophilic polymers of the SAP having electronegative ionic components. High absorbing SAPs are formed from ionic crosslinked hydrophilic polymers such as acrylics and acrylamides in the form of salts or free acids. Because the SAPs are ionic, they are affected by the soluble ionic components within the solution being absorbed and will, for example, absorb less saline than pure water.
  • the lower absorption rate of saline is caused by the sodium and chloride ions blocking some of the water absorbing sites on the SAPs.
  • the fluid being absorbed by the SAP is a solution containing dissolved mineral ions, fewer hydrogen atoms of the water molecules in the solution may be free to bond with the SAP.
  • the ability of an SAP to absorb and retain a fluid may be dependent upon the ionic concentration of the fluid being absorbed.
  • an SAP may absorb and retain de-ionized water up to 500 times the weight of the dry SAP.
  • an SAP may absorb fluid volumes as high as 30 to 60 times the dry volume of the SAP. Other fluids having a higher ionic concentration may be absorbed at lower quantities.
  • an SAP may only absorb and retain a solution that is 0.9% salt (NaCl) up to 50 times the weight of the dry SAP. Since wound fluids contain salts, such as sodium, potassium, and calcium, the absorption capacity of the SAP may be reduced if compared to the absorption capacity of deionized water.
  • salts such as sodium, potassium, and calcium
  • the absorbent may comprise a KERRAMAX CARETM SuperAbsorbent Dressing material available from Kinetic Concepts, Inc. of San Antonio, Texas.
  • the absorbent may comprise a superabsorbent laminate comprised of 304 g.s.m. FAVOR- PACTM 230 superabsorbent powder glued by PAFRATM 8667 adhesive between two layers of 50 g.s.m. LIDROTM non-woven material.
  • the absorbent may comprise an absorbent available from Gelok International. The presence of the absorbent may also help to minimize fluid loss or reflux.
  • FIG 8 is a perspective view illustrating the cover 104 of Figure 7 disposed at the tissue site 102.
  • the tissue site 102 may be an area to tissue without a penetration of the dermis or epidermis but which may receive beneficial effects from the application of a distension force.
  • the cover 104 can be stretched across the tissue site 102.
  • the closure device 202 may be deformed.
  • the closure device 202 may be deformed or stretched in a direction perpendicular to an area of desired distension of the tissue site 102.
  • Figure 9 is a sectional view of the cover 104 of Figure 7 taken along line 9 — 9 of Figure 8.
  • the force deforming the closure device 202 may be released, and the super-elastic properties of the nitinol mesh and the curvature of the concave side 704 and the convex side 706 may create a distension force in an area of tissue at the tissue site 102.
  • the fluid storage device 702 may receive fluid, such as perspiration and secure it away from the surface of the tissue site 102 to prevent maceration and decrease the rate of hydration of the adhesive layer 204.
  • the storage of fluid may permit the cover 104 to remain at the tissue site 102 for longer periods of duration.
  • the distension created by the closure device 202 can distend skin and fascia, dilating lymph and blood vessels and permitting increased blood flow to the tissue site 102.
  • FIG 10 is a plan view of the tissue site 102 having a plurality of closure devices 1002 disposed across an incision of the tissue site 102 in accordance with some embodiments.
  • the closure device 1002 can comprise a rod having a first end 1004 and a second end 1006. Both the first end 1004 and the second end 1006 may have a high-tack, adhesive encapsulating the respective end.
  • the adhesive may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover 104 to epidermis around a tissue site.
  • some or all of the cover 104 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight of about 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks.
  • an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel, as previously described.
  • the adhesive can comprise a 3M 2484 GSA or a Tegaderm acrylic adhesive.
  • each closure device 1002 can be stretched across the tissue site 102, such as an incision.
  • the first end 1004 can be coupled to a first side of the incision of the tissue site 102 with the adhesive.
  • the second end 1006 may be stretched across incision of the tissue site 102 generally perpendicular to the incision of the tissue site 102.
  • the closure device 1002 may be deformed.
  • the closure device 1002 may be deformed or stretched in a direction perpendicular to the incision of the tissue site 102.
  • the second end 1006 of the closure device 1002 may be secured to an opposite side of the incision of the tissue site 102 by the adhesive.
  • FIG 11 is a plan view of the tissue site 102 after a plurality of closure devices 1002 have been disposed at the tissue site 102. After the second end 1006 is secured to the tissue site 102 by the adhesive, the force deforming the closure device 1002 may be released, and the super-elastic properties of the nitinol may help pull the incision of the tissue site 102 closed.
  • the closure devices described herein provide for primary dermal closure of an incision.
  • the devices described herein can provide compressive, appositional, and/or distention forces.
  • the closure devices can be programmable to provide a desired force that limits tensioning of an incision as is the case with traditional sutures or staples.
  • the closure devices described herein may not lose elasticity over time as is the case with other closure devices relying on films or elastics alone.
  • the devices described herein provide a relatively flat force or stress over a wide range of deformation or strain.
  • the closure devices can also provide a known force regardless of how much the closure device is pre-stressed.

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Abstract

L'invention concerne un appareil pour générer une force au niveau d'un site tissulaire. L'appareil peut comprendre un dispositif de fermeture formé à partir d'un matériau super-élastique. Le dispositif de fermeture peut avoir un premier côté, un second côté, une partie de périmètre, et une partie centrale disposée à l'intérieur de la partie de périmètre, la partie centrale étant configurée pour exercer la force au niveau du site de tissu. L'appareil peut également comprendre une couche adhésive disposée adjacente au premier côté du dispositif de fermeture, et une couche de capuchon supérieure disposée de manière adjacente et couplée au second côté du dispositif de fermeture.
PCT/IB2023/058879 2022-09-20 2023-09-07 Pansement doté d'un dispositif de fermeture intégré WO2024062325A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080033334A1 (en) * 2006-08-03 2008-02-07 Gurtner Geoffrey C Devices and bandages for the treatment or prevention of scars and/or keloids and methods and kits therefor
WO2010053870A1 (fr) * 2008-11-07 2010-05-14 Kci Licensing, Inc. Pansement et systèmes de traitement de plaies à pression réduite
WO2020060730A1 (fr) * 2018-09-18 2020-03-26 Maruho Medical, Inc. Dispositif de soins des tissus et procédé d'utilisation
CN113786282A (zh) * 2021-09-15 2021-12-14 电子科技大学 一种用于加速伤口愈合的热激活力电协同敷料及制备方法

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Publication number Priority date Publication date Assignee Title
US20080033334A1 (en) * 2006-08-03 2008-02-07 Gurtner Geoffrey C Devices and bandages for the treatment or prevention of scars and/or keloids and methods and kits therefor
WO2010053870A1 (fr) * 2008-11-07 2010-05-14 Kci Licensing, Inc. Pansement et systèmes de traitement de plaies à pression réduite
WO2020060730A1 (fr) * 2018-09-18 2020-03-26 Maruho Medical, Inc. Dispositif de soins des tissus et procédé d'utilisation
CN113786282A (zh) * 2021-09-15 2021-12-14 电子科技大学 一种用于加速伤口愈合的热激活力电协同敷料及制备方法

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Title
BLACKLOW S. O. ET AL: "Bioinspired mechanically active adhesive dressings to accelerate wound closure", SCIENCE ADVANCES, vol. 5, no. 7, 5 July 2019 (2019-07-05), XP093104139, DOI: 10.1126/sciadv.aaw3963 *
YAO GUANG ET AL: "A programmable and skin temperature-activated electromechanical synergistic dressing for effective wound healing", SCIENCE ADVANCES, vol. 8, no. 4, 28 January 2022 (2022-01-28), XP093104210, DOI: 10.1126/sciadv.abl8379 *
YAO GUANG ET AL: "Supplementary Materials for "A programmable and skin temperature-activated electromechanical synergistic dressing for effective wound healing"", SCIENCE ADVANCES, vol. 8, no. 4, 28 January 2022 (2022-01-28), pages 1 - 22, XP093104312, DOI: 10.1126/sciadv.abl8379 *

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