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US6056970A Expired / Lapsed US ⏱️ 0.0 years remaining

Compositions comprising hemostatic compounds and bioabsorbable polymers

Assignee: Genzyme Corp
•
Filing: 1998-05-07
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Granted: 2000-05-02
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Expires: 2018-05-07
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Abstract

Abstract Solid, fibrous bioabsorbable hemostatic compositions containing a bioabsorbable polymer and a hemostatic compound, methods for making the hemostatic compositions, and methods for using the hemostatic compositions are disclosed.

Inventors

  • 👤 Keith E. Greenawalt
  • 👤 Julia B. Gershkovich

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 12:08
CPC Classifications
A; A61; A61L; A61L15/00; A61L15/16; A61L15/22; A61L15/32; A61L26/00; A61L26/0009; A61L26/0028; A61L26/0042; A61P; A61P41/00; A61L2400/00; A61L2400/04

Claims Analysis

Total Claims: 45
Claim 1
Independent Claim 49 words
A solid, bioabsorbable hemostatic composition comprising a bioabsorbable polymer and a hemostatic compound, wherein the hemostatic compound is dispersed throughout the hemostatic composition, said hemostatic compound prepared by combining, in a non-aqueous solvent, thrombin, fibrinogen and a calcium salt, wherein said fibrinogen is not activated by thrombin during processing.
Claim 2
Dependent Claim 49 words
A solid, bioabsorbable hemostatic composition comprising a bioabsorbable polymer and a hemostatic compound, wherein the hemostatic compound is dispersed throughout the hemostatic composition, said hemostatic compound prepared by combining, in a non-aqueous solvent, thrombin, fibrinogen and a calcium salt, wherein said fibrinogen is not activated by thrombin during processing.
Claim 3
Dependent Claim 26 words
The composition of claim 1 wherein the bioabsorbable polymer is selected from the group consisting of polyanionic polysaccharides, chitin, chitosan, polyglycolide, polylactide, polycaprolactone, and copolymers thereof.
Claim 4
Dependent Claim 13 words
The composition of claim 1 wherein the bioabsorbable polymer is a polyanionic polysaccharide.
Claim 5
Dependent Claim 17 words
The composition of claim 3 wherein the polyanionic polysaccharide is in the form of a water-insoluble derivative.
Claim 6
Dependent Claim 23 words
The composition of claims 3 or 4 wherein the polyanionic polysaccharide is selected from the group consisting of carboxymethylcellulose, carboxymethylamylose, and hyaluronic acid.
Claim 7
Dependent Claim 17 words
The composition of claims 3 or 4 wherein the hemostatic composition comprises two or more polyanionic polysaccharides.
Claim 8
Dependent Claim 13 words
The composition of claim 3 or 4 further comprising a hydrophobic bioabsorbable polymer.
Claim 9
Dependent Claim 26 words
The composition of claim 7 wherein the hydrophobic bioabsorbable polymer is selected from the group consisting of polyglycolide, polylactide, polydioxanones, polyestercarbonates, polyhydroxyalkonates, polylactones and copolymers thereof.
Claim 10
Dependent Claim 21 words
The composition of claim 1 wherein the thrombin is present at a concentration between about 1 and 100 U/cm 2 .
Claim 11
Dependent Claim 21 words
The composition of claim 1 wherein the fibrinogen is present in a concentration between about 0.05 and 20 mg/cm 2 .
Claim 12
Dependent Claim 12 words
The composition of claim 1 wherein the calcium salt is calcium chloride.
Claim 13
Dependent Claim 21 words
The composition of claim 1 wherein the calcium salt is present in a concentration between 0.01 and 10 mg/cm 2 .
Claim 14
Dependent Claim 21 words
The composition of claim 11 wherein the fibrinogen is present in a concentration between about 0.05 and 20 mg/cm 2 .
Claim 15
Dependent Claim 27 words
The composition of claim 1 further comprising Factor XIII, fibronectin, plasminogen, aprotinin, alpha-2-antiplasmin, alpha-2-macroglobulin, alpha-1-antitrypsin, epsilon-aminocaproic acid, tranexamic acid, a plasmin activator inhibitor, or a combination thereof.
Claim 16
Dependent Claim 9 words
The composition of claim 1 further comprising protamine sulfate.
Claim 17
Dependent Claim 9 words
The composition of claim 1 further comprising a drug.
Claim 18
Dependent Claim 27 words
The composition of claim 16 wherein the drug is selected from the group consisting of growth factors, growth factor inhibitors, antibodies, non-steroidal anti-inflammatory agents, antibiotics and cytokines.
Claim 19
Dependent Claim 16 words
The composition of claim 1 having a mass/area between about 15 and 50 mg/cm 2 .
Claim 20
Dependent Claim 15 words
The composition of claim 1 wherein the composition is provided in a waterproof, sterile package.
Claim 21
Dependent Claim 12 words
The composition of claim 1 further comprising a medically acceptable adhesive backing.
Claim 22
Dependent Claim 19 words
The composition of claim 1 wherein the composition is formed to fit over the ends of a vascular prosthesis.
Claim 23
Dependent Claim 9 words
A kit comprising the hemostatic composition of claim 1.
Claim 24
Dependent Claim 15 words
The composition of claim 1 wherein the hemostatic compound is dispersed evenly throughout the composition.
Claim 25
Dependent Claim 14 words
The composition of claim 1 wherein the hemostatic compound is present as a gradient.
Claim 26
Dependent Claim 25 words
The composition of claim 1 further comprising a bilayer composition with one layer containing the hemostatic compound and the other layer containing the bioabsorbable polymer.
Claim 27
Independent Claim 66 words
A method of making a solid, bioabsorbable hemostatic composition comprising the steps of a) admixing a bioabsorbable polymer and a hemostatic compound in a non-aqueous solvent to form a fibrous pulp, said hemostatic compound comprising thrombin, fibrinogen and a calcium salt, wherein the thrombin does not activate the fibrinogen during processing; and b) subjecting the fibrous pulp to a paper-making process to form a paper product.
Claim 28
Independent Claim 66 words
A method of making a solid, bioabsorbable hemostatic composition comprising the steps of a) admixing a bioabsorbable polymer and a hemostatic compound in a non-aqueous solvent to form a fibrous pulp, said hemostatic compound comprising thrombin, fibrinogen and a calcium salt, wherein the thrombin does not activate the fibrinogen during processing; and b) subjecting the fibrous pulp to a paper-making process to form a paper product.
Claim 29
Dependent Claim 32 words
The method of claim 26 wherein the non-aqueous solvent is selected from the group consisting of straight-chain or branched C1-C5 alcohols, ketones, aliphatic ethers, cycloaliphatic ethers, esters, nitrites, and aliphatic halogenated hydrocarbons.
Claim 30
Dependent Claim 12 words
The method of claim 27 wherein the non-aqueous solvent is an alcohol.
Claim 31
Dependent Claim 10 words
The method of claim 28 wherein the alcohol is ethanol.
Claim 32
Dependent Claim 13 words
The method of claim 28 wherein the alcohol is 95% to 100% ethanol.
Claim 33
Dependent Claim 18 words
The method of claim 26 wherein the bioabsorbable polymer and hemostatic compound are admixed under high shear conditions.
Claim 34
Dependent Claim 33 words
The method of claim 26 wherein the paper-making process includes the steps a) collecting the fibrous pulp from the non-aqueous solvent; b) pressing the collected fibrous pulp; and c) drying the pressed pulp.
Claim 35
Dependent Claim 15 words
The method of claim 32 wherein the fibrous pulp is collected onto a forming fabric.
Claim 36
Dependent Claim 24 words
The method of claim 33 wherein the forming fabric is selected from the group consisting of Teflon mesh, stainless steel mesh and polyester fabric.
Claim 37
Dependent Claim 13 words
The method of claim 33 wherein the forming fabric is a polyester fabric.
Claim 38
Dependent Claim 15 words
The method of claim 32 wherein the collected fibrous pulp is subjected to heat compression.
Claim 39
Independent Claim 68 words
A method for inhibiting or stopping blood loss from a wound comprising contacting the wound with a solid, biodegradeable hemostatic composition comprising a bioabsorbable polymer and a hemostatic compound for a period of time sufficient to promote blood clotting to occur, said hemostatic compound being prepared by combining, in a non-aqueous solvent, thrombin, fibrinogen and a calcium salt, wherein said fibrinogen is not activated by thrombin during processing.
Claim 40
Independent Claim 68 words
A method for inhibiting or stopping blood loss from a wound comprising contacting the wound with a solid, biodegradeable hemostatic composition comprising a bioabsorbable polymer and a hemostatic compound for a period of time sufficient to promote blood clotting to occur, said hemostatic compound being prepared by combining, in a non-aqueous solvent, thrombin, fibrinogen and a calcium salt, wherein said fibrinogen is not activated by thrombin during processing.
Claim 41
Dependent Claim 17 words
The method of claim 37 further comprising applying manual pressure hemostatic composition after contact with the wound.
Claim 42
Dependent Claim 13 words
The method of claim 37 wherein the wound is caused by accidental trauma.
Claim 43
Dependent Claim 14 words
The method of claim 37 wherein the wound is due to a surgical procedure.
Claim 44
Dependent Claim 13 words
A solid, bioabsorbable hemostatic composition prepared according to the method of claim 26.
Claim 45
Dependent Claim 13 words
A solid, bioabsorbable hemostatic composition prepared according to the method of claim 32.

References Cited (Backward Citations)

US4442655A Cited
US4655211A Cited
US4810775A Cited
US5631011A Cited
US5643596A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-05-02 2003-11-01 2004-05-02 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2007-05-02 2007-11-01 2008-05-02 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2011-05-02 2011-11-01 2012-05-02 $7700.00 Window Closed / Lapsed

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