Hemostatic tissue sealants

• US 6,162,241 A
• Filed: 08/05/1998
• Issued: 12/19/2000
• Est. Priority Date: 08/06/1997
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Sawhney, Amarpreet S., Hubbell, Jeffrey A., Coury, Arthur J., Philbrook, C. Michael
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/129,735
• Time in Patent Office: 867 Days
• Field of Search: 606/213-216, 528/354, 528/361, 528/54.1, 528/54.2, 424/426
• US Class Current: 606/214
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/722 Chitin, chitosan
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 26/0019 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: C08G 63/64 Polyesters containing both carboxylic ester groups and carbonate groups
• CPC Class Codes: C08G 63/676 in which at least one of the two components contains aliphatic unsaturation
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A method of controlling hemostasis by applying a hemostatic agent in a tissue sealant composition. The tissue sealant is a biodegradable, biocompatible synthetic polymer that may not intrinsically possess strong hemostatic properties. Inclusion of a hemostatic material in the tissue sealant can control bleeding at the site and may also provide improved adherence of the sealant to tissue and provide shorter healing times.

Claims

1. A hemostatic tissue sealant, comprising:

a biocompatible, biodegradable hydrogel tissue sealant comprising crosslinkable groups having incorporated therein an effective amount of a hemostatic agent to stop the flow of blood from tissue in a medically acceptable period of time.

2. A hemostatic tissue sealant as in claim 1, wherein the hemostatic agent is selected from the group consisting of coagulation factors, coagulation initiators, platelet activators, vasoconstrictors, and fibrinolysis inhibitors.

3. A hemostatic tissue sealant as in claim 1, wherein the hemostatic agent is selected from the group consisting of epinephrine, adrenochrome, collagens, thrombin, fibrin, fibrinogen, oxidized cellulose, and chitosan.

4. A hemostatic tissue sealant as in claim 1, wherein the crosslinkable materials are self-crosslinking to form a seal.

5. A hemostatic tissue sealant as in claim 1, wherein the hydrogel is a photopolymerizable gel.

6. A hemostatic tissue sealant as in claim 1, wherein the hydrogel tissue sealant is formed of crosslinkable materials which contain crosslinkable groups, hydrophilic regions, and biodegradable regions.

7. A hemostatic tissue sealant as in claim 6, wherein the crosslinkable materials covalently crosslink by free radical initiated polymerization.

8. A hemostatic tissue sealant as in claim 6, wherein the crosslinkable materials are crosslinked by the application of one or more initiators of polymerization.

9. A hemostatic tissue sealant as in claim 8, wherein the one or more initiators of polymerization comprise oxidizers, heat and light.

10. A hemostatic tissue sealant as in claim 6, wherein the crosslinkable materials covalently crosslink by free radical initiated polymerization.

11. A hemostatic tissue sealant as in claim 6, wherein the hydrophilic regions comprise polyethylene glycol, the crosslinkable groups comprise hydrocarbon unsaturated groups and the biodegradable regions comprise poly(hydroxy acid).

12. A hemostatic tissue sealant composition comprising a biodegradable, biocompatible crosslinkable material that will function as a tissue sealant when crosslinked, having incorporated therein a hemostatic agent in an amount sufficient to stop the flow of blood from a tissue surface in a medically acceptable amount of time.

13. A method for forming a hemostatic sealant on a tissue surface, comprising:

applying the hemostatic sealant composition of claim 12 to the tissue surface; and

crosslinking the crosslinkable groups.

14. The method of claim 13, wherein the crosslinkable material includes crosslinkable groups, hydrophilic regions, and biodegradable regions.

15. The composition of claim 12, wherein the hydrophilic regions comprise polyethylene glycol, the crosslinkable groups comprise hydrocarbon unsaturated groups and the biodegradable regions comprise poly(hydroxy acid).

16. The method of claim 13, further comprising the step of applying an initiator primer to the tissue surface prior to application of the hemostatic sealant composition.

17. The composition of claim 12, wherein the hemostatic agent is selected from the group consisting of coagulation factors, coagulation initiators, platelet activators, vasoconstrictors, and fibrinolysis inhibitors.

18. The composition of claim 12, wherein the hemostatic agent is selected from the group consisting of epinephrine, adrenochrome, collagens, thrombin, fibrin, fibrinogen, oxidized cellulose, and chitosan.