WO2006044879A2 - Absorbable hemostat - Google Patents

Absorbable hemostat Download PDF

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Publication number
WO2006044879A2
WO2006044879A2 PCT/US2005/037403 US2005037403W WO2006044879A2 WO 2006044879 A2 WO2006044879 A2 WO 2006044879A2 US 2005037403 W US2005037403 W US 2005037403W WO 2006044879 A2 WO2006044879 A2 WO 2006044879A2
Authority
WO
WIPO (PCT)
Prior art keywords
hemostat
cellulose
foam
knitted fabric
absorbable
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/US2005/037403
Other languages
English (en)
French (fr)
Other versions
WO2006044879A3 (en
Inventor
Guanghui Zhang
Sonia Martins
Robin Peters
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.)
Omrix Biopharmaceuticals SA
Ethicon Inc
Omrix Biopharmaceuticals Inc
Original Assignee
Omrix Biopharmaceuticals SA
Ethicon Inc
Omrix Biopharmaceuticals 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
Priority to AU2005295365A priority Critical patent/AU2005295365B2/en
Priority to JP2007537971A priority patent/JP5191736B2/ja
Priority to EP05813108.7A priority patent/EP1809342B1/en
Priority to BRPI0516764A priority patent/BRPI0516764B8/pt
Priority to CA2584679A priority patent/CA2584679C/en
Priority to PL05813108T priority patent/PL1809342T3/pl
Priority to US11/577,207 priority patent/US20080260810A1/en
Priority to DK05813108.7T priority patent/DK1809342T3/en
Application filed by Omrix Biopharmaceuticals SA, Ethicon Inc, Omrix Biopharmaceuticals Inc filed Critical Omrix Biopharmaceuticals SA
Priority to ES05813108.7T priority patent/ES2552233T3/es
Publication of WO2006044879A2 publication Critical patent/WO2006044879A2/en
Publication of WO2006044879A3 publication Critical patent/WO2006044879A3/en
Priority to IL182565A priority patent/IL182565A/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61F13/01029—Non-adhesive bandages or dressings characterised by the structure of the dressing made of multiple layers
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    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
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    • B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
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    • B32B5/22—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • B32B5/24—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer
    • B32B5/26—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer another layer next to it also being fibrous or filamentary
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    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • A—HUMAN NECESSITIES
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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Definitions

  • the present invention relates to a hemostat.
  • the control of bleeding, as well as sealing of air and various bodily fluids is essential and critical in surgical procedures to minimize blood loss, to seal tissue and organ structures, to reduce post-surgical complications, and to shorten the duration of the surgery in the operating room.
  • therapeutic agents including, but not limited to, thrombin, fibrin and fibrinogen have been combined with dressing carriers or substrates, including gelatin-based carriers, polysaccharide-based carriers, glycolic acid or lactic acid-based carriers and a collagen matrix.
  • dressing carriers or substrates including gelatin-based carriers, polysaccharide-based carriers, glycolic acid or lactic acid-based carriers and a collagen matrix. Examples of such dressings are disclosed in USP 6,762,336, USP 6,733,774 and PCT publication WO 2004/064878 Al.
  • carboxylic- oxidized cellulose Due to its biodegradability and its bactericidal, tissue sealing, tissue repairing, drug delivering and hemostatic properties, it is desirable to utilize cellulose that has been oxidized to contain carboxylic acid moieties, hereinafter referred to as carboxylic- oxidized cellulose, as a topical dressing in a variety of surgical procedures, including neurosurgery, abdominal surgery, cardiovascular surgery, thoracic surgery, head and neck surgery, pelvic surgery and skin and subcutaneous tissue procedures.
  • the present invention is directed towards a hemostat comprising an absorbable foam, an absorbable woven or knitted fabric, thrombin and fibrinogen.
  • the hemostat described herein provides and maintains effective hemostasis when applied to a wound requiring hemostasis.
  • Effective hemostasis is the ability to control and/or abate capillary, venous, or arteriole bleeding within an effective time, as recognized by those skilled in the art of hemostasis. Further indications of effective hemostasis may be provided by governmental regulatory standards and the like.
  • hemostats of the present invention are effective in providing and maintaining hemostasis in cases of severe or brisk bleeding.
  • severe bleeding is meant to include those cases of bleeding where a relatively high volume of blood is lost at a relatively high rate.
  • severe bleeding include, without limitation, bleeding due to arterial puncture, liver resection, blunt liver trauma, blunt spleen trauma, aortic aneurysm, bleeding from patients with over- anticoagulation, or bleeding from patients with coagulopathies, such as hemophilia.
  • the hemostat generally comprises an absorbable foam and a reinforcement fabric.
  • the reinforcement fabric provides a backing to which the foam may be attached, either directly or indirectly, wherein thrombin and fibrinogen are substantially homogeneously dispersed throughout the foam and/or are disposed on the surface of the foam.
  • the reinforcement fabric provides strength to the hemostat sufficient to permit the user to place and manipulate the hemostat on or within a wound or directly onto tissue of a patient requiring hemostasis, or tissue sealing and adhering.
  • the foam also serves to shield the thrombin and fibrinogen from acidic moieties that may be present in the reinforcement fabric, such as is the case where carboxylic-oxidized cellulose is used as the reinforcement fabric.
  • the foam may be a biocompatible, water-soluble, or water-swellable polymer and a foaming agent/surfactant.
  • Preferred biocompatible, water-soluble, or water- swellable polymers used to fabricate the foam include polysaccharides.
  • Such polysaccharides include, without limitation, cellulose, alkyl cellulose, e.g. methylcellulose, alkylhydroxyalkyl cellulose, hydroxyalkyl cellulose, cellulose sulfate, salts of carboxymethyl cellulose, carboxymethyl cellulose, and carboxyethyl cellulose.
  • albumin chitin, carboxymethyl chitin, hyaluronic acid, salts of hyaluronic acid, alginate, alginic acid, propylene glycol alginate, glycogen, dextran, dextran sulfate, curdlan, pectin, pullulan, xanthan, chondroitin, chondroitin sulfates, carboxymethyl dextran, carboxymethyl chitosan, chitosan, heparin, heparin sulfate, heparan, heparan sulfate, dermatan sulfate, keratan sulfate, carrageenans, chitosan, starch, amylose, amylopectin, poly-N-glucosamine, polymannuronic acid, polyglucuronic acid polyguluronic acid, and derivatives of any of the above, may be utilized. Even more preferably, biocompatible, water-soluble, or water-
  • the foaming agent/surfactant may be a cationic, anionic, amphoteric, zwitterionic or nonionic surfactant, or natural or modified proteins, including but without limitation, albumin, sodium lauryl sulfate, sodium laureth sulfate, or ammonia lauryl sulfate.
  • a preferred foaming agent/surfactant is albumin, and more preferably, human serum albumin (HSA).
  • the reinforcement fabric is an absorbable woven or knitted fabric and comprises oxidized polysaccharides, in particular oxidized cellulose and the neutralized derivatives thereof.
  • the cellulose may be carboxylic-oxidized or aldehyde-oxidized cellulose.
  • oxidized regenerated polysaccharides including but without limitation oxidized regenerated cellulose, may be used to prepare the second absorbable woven or knitted fabric. Regenerated cellulose is preferred due to its higher degree of uniformity versus cellulose that has not been regenerated.
  • fabrics that may be utilized as the reinforcement fabric include, but are not limited to, Interceed ® absorbable adhesion barrier, Surgicel ® absorbable hemostat, Surgicel Nu-Knit ® absorbable hemostat and Surgicel ® Fibrillar absorbable hemostat (each available from Johnson & Johnson Wound Management Worldwide or Gynecare Worldwide, each a division of Ethicon, Inc., Somerville, New Jersey).
  • the reinforcement fabric utilized in the present invention may be woven or knitted, provided that the fabric possesses the physical properties necessary for use in contemplated applications. Such fabrics, for example, are described in USP 4,626,253, USP 5,002,551 and USP 5,007,916, the contents of which are hereby incorporated by reference herein as if set forth in its entirety. Jn preferred embodiments, the reinforcement fabric is a warp knitted tricot fabric constructed of bright rayon yarn that is subsequently oxidized to include carboxyl or aldehyde moieties in amounts effective to provide the fabrics with biodegradability.
  • the reinforcement fabric comprises oxidized polysaccharide fibers in combination with fibers comprised of aliphatic polyester polymers, copolymers, or blends thereof.
  • the reinforcement fabric preferably comprises oxidized regenerated cellulose and may have a basis weight ranging from about 0.001 to 0.2 g/in 2 , preferably in the range of about 0.01 to 0.1 g/in 2 , and most preferably in the range of about 0.04 to 0.07 g/in 2 .
  • a foam slurry may be prepared from, for example, CMC-Na and HSA, and then spread on the surface of, for example, an oxidized regenerated cellulose fabric.
  • the ratio of the water-soluble or water-swellable polymer to the foaming agent may range from about 1:8 to 8: 1 by weight, and preferably from about 2: 1 to 1 :2 by weight.
  • the foam slurry is then dried either by lyophilization or in an oven at elevated temperature to form a solid foam substrate.
  • the foam substrate may be treated with a chemical cross-linking agent such as glutaraldehyde for increased strength or may be partly cross-linked by heating.
  • the density of the hemostat may be from about 5 to 20 mg/cm 3 .
  • the thrombin and fibrinogen may be animal derived, preferably human, or may be recombinant.
  • the thrombin activity on the hemostat may be in the range of about 20 to 500 IU/cm 2 , preferably about 20 to 200 IU/cm 2 , and most preferably about 50 to 200 IU/cm .
  • the fibrinogen activity on the hemostat may be in the range of about 2 to 15 mg/cm 2 , preferably about 3 to 10 mg/cm 2 , and most preferably about 4 to 7 mg/cm 2 .
  • Thrombin powders may be prepared by lyophilization of thrombin solutions.
  • Fibrinogen may be prepared by lyophilizaton of solutions containing fibrinogen, such as those described in USP 6,121,232 and PCT Application Publication No. WO 02/095019. Dry powders of fibrinogen and thrombin suspended in an organic solvent such as PF5060 or HFE 7000 — 7300 series are then sprayed onto the surface of the foam. Alternatively, the thrombin and fibrinogen may be incorporated into the foam during the foam production.
  • the hemostat may comprise a first foam having incorporated thereon or therein a first therapeutic agent, e.g., fibrinogen, and a second foam separate (unattached) from the first foam that may have upon or incorporated therein powders of a second therapeutic agent, e.g. thrombin.
  • a hemostat may comprise a reinforcement fabric having a first foam adjacent thereto and second foam on the other side of the first foam. While either thrombin or fibrinogen may be incorporated into first foam, fibrinogen is preferred. While either thrombin or fibrinogen may be incorporated with the second foam, thrombin is preferred.
  • the foam slurries used to prepare the first and second foams are selected such that the second foam is less dense than the first foam so that it liquefies or melts quickly after coming into contact with blood at the wound site to start the clotting process.
  • the second foam contacts the bleeding site first, then the combined reinforcing layer and first foam keeps the clot from being washed away by the blood flow.
  • the hemostat may optionally include without limitation, procoagulant enzymes, proteins and peptides, may be naturally occurring, recombinant, or synthetic, and may be selected from the group consisting of prothrombin, fibrin, fibronectin, heparinase, Factor X/Xa, Factor VIFVIIa, Factor JXJTXa, Factor XITXIa, Factor XWXEa, tissue factor, batroxobin, ancrod, ecarin, von Willebrand Factor, collagen, elastin, albumin, gelatin, platelet surface glycoproteins, vasopressin and vasopressin analogs, epinephrine, selectin, procoagulant venom, plasminogen activator inhibitor, platelet activating agents, synthetic peptides having hemostatic activity, derivatives of the above and any combination thereof.
  • procoagulant enzymes may be naturally occurring, recombinant, or synthetic, and may be selected from the group consisting of prothro
  • the hemostat described herein may also be used as an adjunct to primary wound closure devices, such as arterial closure devices, staples, and sutures, to seal potential leaks of gasses, liquids, or solids as well as to provide hemostasis.
  • primary wound closure devices such as arterial closure devices, staples, and sutures
  • the hemostat may be utilized to seal air from tissue or fluids from organs and tissues, including but not limited to, bile, lymph, cerebrospinal fluids, gastrointestinal fluids, interstitial fluids and urine.
  • the hemostat described herein has additional medical applications and may be used for a variety of clinical functions, including but not limited to tissue reienforcement and buttressing, i.e., for gastrointestinal or vascular anastomoses, approximation, i.e., to connect anastomoses that are difficult to perform (i.e. under tension), and tension releasing.
  • the hemostat may additionally promote and possibly enhance the natural tissue healing process in all the above events.
  • This hemostat can be used internally in many types of surgery, including, but not limited to, cardiovascular, peripheral- vascular, cardio-thoracic, gynecological, neuro- and general surgery.
  • the hemostat may also be used to attach medical devices (e.g. meshes, clips and films) to tissues, tissue to tissue, or medical device to medical device.
  • Example 1 Lyophilized CMC-Na/ HSA foam with ORC fabric
  • a mixing bowl were added 190 mL of a 2% solution of sodium carboxy methylcellulose (CMC-Na) (Aqualon, catalog No. 7M8SFPH) and 10 mL of a 20% solution of human serum albumin (HSA) (ALBUTEEMTM, Alpha Therapeutic Corporation).
  • HSA human serum albumin
  • the mixture was whipped mechanically to generate a foamed slurry.
  • the foamed slurry was transferred to a rectangular frame having a piece of knitted carboxylic-oxidized regenerated cellulose fabric, available from Ethicon, Inc. under the tradename Interceed ® , disposed at the bottom.
  • the foamed slurry was then spread evenly across the whole frame to yield a thickness of about 3 mm.
  • the foamed slurry was then lyophilized to remove solvent, thus yielding a solid CMC-NaTHSA foam adjacent and attached to the ORC fabric.
  • CMC-Na sodium carboxy methylcellulose
  • HSA human serum albumin
  • the foamed slurry was transferred to a rectangular frame having a piece of carboxylic- oxidized regenerated cellulose fabric, available from Ethicon, Inc. under the tradename Interceed ® , at the bottom.
  • the foamed slurry was then spread evenly across the whole frame to yield a thickness of about 3 mm.
  • the foamed slurry was then heated in an oven at 65°C for an hour to remove solvent and thus yielded a solid CMC-Na/HS A foam adjacent and attached to the ORC fabric.
  • Hemostatic agents were applied to the constructs prepared in Examples 1 and 2 as below.
  • the constructs were cut into 3" x 4" pieces.
  • Lyophilized thrombin and Biological Active Components 2 (B AC-2) containing fibrinogen were ground to powder separately.
  • the thrombin powder and the B AC-2 powder were passed through a 45-micrometer sieve. The two powders were weighed to provide a final fibrinogen
  • CMC-Na sodium carboxy methylcellulose
  • HSA human serum albumin
  • CMC-Na sodium carboxy methylcellulose
  • HSA human serum albumin
  • Example 7 Hemostasis test with CMC-Na/HSA/Thrombin foam and CMC- Na/HS A/Fibrinogen. foam
  • a severe bleeding wound was made on a swine liver.
  • the defect was created by making a triangular cut with a surgical scalpel. Each side measured about 1 inch and the depth measured 5mm.
  • CMC- Na/HSA/Thrombin foam (I" x 1") was quickly applied to the wound.
  • a piece of CMC- Na/HS A/Fibrinogen foam was then applied on top of the thrombin foam followed by manual compression. Hemostasis was achieved in 2 minutes.

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US11/577,207 US20080260810A1 (en) 2004-10-20 2005-10-17 Hemostat
EP05813108.7A EP1809342B1 (en) 2004-10-20 2005-10-17 Absorbable hemostat
BRPI0516764A BRPI0516764B8 (pt) 2004-10-20 2005-10-17 hemostato
CA2584679A CA2584679C (en) 2004-10-20 2005-10-17 Hemostat
PL05813108T PL1809342T3 (pl) 2004-10-20 2005-10-17 Wchłanialny hemostat
AU2005295365A AU2005295365B2 (en) 2004-10-20 2005-10-17 Absorbable hemostat
JP2007537971A JP5191736B2 (ja) 2004-10-20 2005-10-17 吸収性止血材
DK05813108.7T DK1809342T3 (en) 2004-10-20 2005-10-17 absorbable hemostat
ES05813108.7T ES2552233T3 (es) 2004-10-20 2005-10-17 Hemostato absorbible
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