Fibrin sealants and platelet concentrates applied to effect hemostasis at the interface of an implantable medical device with body tissue

• US 20060190017A1
• Filed: 11/18/2005
• Published: 08/24/2006
• Est. Priority Date: 11/19/2004
• Status: Abandoned Application

• Current Assignee: Arteriocyte Medical Systems, Inc (Isto Biologics, Inc.)
• Original Assignee: Arteriocyte Medical Systems, Inc (Isto Biologics, Inc.)
• Inventors: Cyr, John St., Shecterle, Linda M., Rakow, Nancy
• Application Number:
  US11/282,276
• Publication Number:
  US 20060190017A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61L 15/32 Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin A61L15/225 takes precedence
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts

Abstract

Surgical methods of and kits for applying and stabilizing a mass of fibrin sealant or platelet concentrate at the site of surgical attachment of an implantable medical device to effect hemostasis to stem internal bleeding at the site of surgical attachment are disclosed. A mass of fibrin sealant or platelet concentrate is applied onto a porous fabric, whereby the mass is supported in the interstices or pores of the fabric, and the supported mass is applied against the site of high pressure blood leakage. The supported mass achieves hemostasis as it does not wash away from the site. The present invention is particularly useful to effect hemostasis at sutures and suture holes extending through thin-walled tissue valves and grafts when such tissue valves or grafts are sutured in place, particularly at high blood pressure sites as at the valve annulus of the aortic valve or the aorta.

Claims

1. A method of providing hemostasis at a site of blood leakage comprising applying a fabric and a platelet concentrate to the site of blood leakage to provide hemostasis at the site.

2. The method of claim 1, wherein the platelet concentrate comprises an autologous platelet gel.

3. The method of claim 1, further comprising applying a fibrin sealant to the site.

4. The method of claim 1, wherein the site of blood leakage comprises sutures.

5. The method of claim 4, wherein the sutures attach an implantable medical device to an implantation site.

6. The method of claim 5, wherein the implantable medical device is a prosthetic aortic valve.

7. The method of claim 4, wherein the sutures attach a prosthetic aortic graft to the site.

8. The method of claim 1, wherein the blood leakage is high pressure blood leakage.

9. The method of claim 1, wherein the blood leakage is due to trauma.

10. The method of claim 1, wherein the fabric comprises a porous material.

11. The method of claim 10, wherein the porous material is foamed gelatin, knitted oxidized regenerated cellulose or a combination thereof.

12. The method of claim 1, wherein the fabric comprises surgical hemostatic felt.

13. The method of claim 1 wherein the fabric is biocompatible.

14. The method of claim 1 wherein the fabric is bioabsorbable.

18. A kit comprising packaging material enclosing, separately packaged, pre-formed porous fabric strips and instructions for use according to the method of claim 1.

19. The kit of claim 18, further comprising an implantable medical device.

20. The kit of claim 18, further comprising an implantable graft.

15. A method of providing hemostasis at a site of blood leakage comprising applying a fabric and a fibrin sealant to the site of blood leakage to provide hemostasis at the site.

16. The method of claim 15, further comprising applying a platelet concentrate to the site.

17. The method of claim 16, wherein the platelet concentrate comprises an autologous platelet gel.