Polymeric sealant for medical use

• US 8,088,095 B2
• Filed: 02/08/2007
• Issued: 01/03/2012
• Est. Priority Date: 02/08/2007
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Hissong, James Britton, Oliver, Dana A., Lewis, Cecil O., Saunier, Janis, Myntti, Matthew F.
• Primary Examiner(s): Azpuru, Carlos
• Assistant Examiner(s): Browe, David
• Application Number:
  US11/704,115
• Publication Number:
  US 20080195037A1
• Time in Patent Office: 1,790 Days
• Field of Search: None
• US Class Current: 604/48
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/108 Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 26/0014 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 26/0019 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 26/0023 Polysaccharides
• CPC Class Codes: A61L 26/0047 Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042
• CPC Class Codes: A61L 26/0066 Medicaments; Biocides
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: C09J 133/14 of esters containing halogen, nitrogen, sulfur or oxygen atoms in addition to the carboxy oxygen
• CPC Class Codes: C09J 139/06 : Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C09J 167/00 : Adhesives based on polyesters obtained by reactions forming a carboxylic ester link in the main chain based on polyester-amides C09J177/12; based on polyester-imides C09J179/08; Adhesives based on derivatives of such polymers
• CPC Class Codes: C09J 167/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C09J167/06 takes precedence
• CPC Class Codes: C09J 169/00 : Adhesives based on polycarbonates; Adhesives based on derivatives of polycarbonates
• CPC Class Codes: C09J 175/04 : Polyurethanes
• CPC Class Codes: C09J 177/00 : Adhesives based on polyamides obtained by reactions forming a carboxylic amide link in the main chain based on polyhydrazides C09J179/06; based on polyamide-imides C09J179/08; Adhesives based on derivatives of such polymers
• CPC Class Codes: C09J 179/02 : Polyamines
• CPC Class Codes: C09J 185/02 : containing phosphorus

Abstract

The invention provides a polymeric film-forming medical sealant. The medical sealant is useful for application to the tonsils and adenoids, wherein the sealant performs at least one of the following functions, a) inhibit the colonization of bacteria, b) inhibit the binding of bacteria to tissue, c) reduction of tissue morbidity, d) hemostasis, e) coating and protection of tissue during healing. e) promotion of healing, and f) reduction of pain.

Claims

1. A method of postoperative surgical site treatment for use after removal of the tonsils or adenoids which comprises the step of applying to throat tissue a powder which forms into a medical sealant, the powder comprising chitosan and a crosslinking agent comprising an aldehyde, wherein the sealant performs at least one of the following functions:

a) inhibits the colonization of bacteria, b) inhibits the binding of bacteria to tissue, c) reduces tissue morbidity, d) hemostasis, e) coats and protects tissue during healing, f) promotes healing, or g) reduces pain.

2. A method according to claim 1 wherein the sealant is a crosslinked synthetic polymer.

3. A method according to claim 1 wherein the sealant is a crosslinked natural polymer.

4. A method according to claim 1 wherein the sealant inhibits the colonization of bacteria.

5. A method according to claim 1 wherein the sealant inhibits the binding of bacteria to tissue.

6. A method according to claim 1 wherein the powder reduces tissue morbidity in tissue to which it is applied.

7. A method according to claim 1 wherein the powder reduces bleeding.

8. A method according to claim 1 wherein the powder coats and protects tissue.

9. A method according to claim 1 wherein the powder promotes healing.

10. A method according to claim 1 wherein the powder reduces pain in tissue to which it is applied.

11. A method according to claim 1 wherein the sealant is a viscoelastic material.

12. A method according to claim 1 wherein the sealant hardens or crosslinks to form a semi-pliable barrier upon application.

13. A method according to claim 1 wherein the sealant has a residence time of at least one day.

14. A method according to claim 1 wherein the sealant has a residence time of at least one week.

15. A method according to claim 1 wherein the sealant has a residence time of at least one month.

16. A method according to claim 1 comprising applying the chitosan and crosslinking agent as an atomized powder mixture.

17. A method according to claim 1 wherein the crosslinking agent comprises formaldehyde.

18. A method according to claim 1 wherein the crosslinking agent comprises glutaraldehyde.

19. A method according to claim 1 wherein the powder includes at least one therapeutic agent selected from the group consisting of analgesics, antihistamines, anti-infective agents, anti-fungal agents, biostatic compositions, anti-inflammatory agents, anti-cholinergics, anti-neoplastic agents, cytokines, decongestants, vitamins, peptides, proteins, nucleic acids, immunosuppressors, vasoconstrictors and mixtures thereof.

20. A method according to claim 1 wherein the powder includes a blood product.

21. A method according to claim 1 wherein the sealant further comprises a synthetic polymer selected from poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acids), poly(glycolic acids), polycaprolactones, polyamides, poly(malic acids), polyanhydrides, polyamino acids, polyorthoesters, polyetheresters, polycyanoacrylates, polyphosphazines, polyphosphoesters, polyesteramides, polydiozanones, polyacetals, polyketals, polycarbonates, degradable polyurethanes, polyvinyl pyrrolidones, polyhydroxybutyrates, polyhydoxyvalerates, polyalkylene oxalates, polyalkylene succinates, and copolymers, terpolymers, blends, and mixtures thereof.

22. A method according to claim 1, wherein the powder performs hemostasis, promotes healing and reduces pain.