Pledget-handling system and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure

• US 20050033360A1
• Filed: 05/28/2004
• Published: 02/10/2005
• Est. Priority Date: 11/08/2001
• Status: Active Grant

• Current Assignee: Allen Family Trust, Boston Scientific Scimed (Boston Scientific Corporation), Bruce Feuchter, FirstMark II LP (FirstMark Capital, LLC), Geoffrey O. Hartzler, George Wallace, Pacific Venture Group II, L.P., PVG Associates II, L.P., Kingsbury Capital Partners, L.P. III (Timothy J. Wollaeger, MBA), Kingsbury Capital Partners, L.P. IV (Timothy J. Wollaeger, MBA)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Tangherlini, Vincent C., Sing, Eduardo Chi, Ashby, Mark, Cragg, Andrew, Bowes, Robert, Furey, Tom, Urquidi, Luis
• Granted Patent: US 7,192,436 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen

Abstract

A system and method for delivering a pledget of hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, having an introducer sheath having an inner diameter and an outer diameter, a control tip coupled to the introducer sheath, and a self-expandable member disposed around a portion of the control tip to control blood flow at the blood vessel puncture.

Claims

1. A system for delivering a pledget of hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:

an introducer sheath having an inner diameter and an outer diameter;

a control tip coupled to said introducer sheath; and

,

a self-expandable member disposed around a portion of said control tip to control blood flow at the blood vessel puncture, the self-expandable member having a proximal end and a distal end.

2. The system of claim 1 wherein said self-expandable member is flexible.

3. The system of claim 1 wherein said self-expandable member is deformable.

4. The system of claim 1 wherein said control tip comprises an enlarged distal end and said self-expandable member means is connected to said enlarged distal end.

5. The system of claim 1 wherein said self-expandable member comprises a plurality of resilient disks.

6. The system of claim 5 wherein a diameter of each of the plurality of resilient disks are greater than the inner diameter of the sheath.

7. The system of claim 1 wherein said self-expandable member comprises a plurality of O-rings.

8. The system of claim 7 wherein a diameter of each of the plurality of O-rings are greater than the inner diameter of the sheath.

9. The system of claim 1 wherein said self-expandable member has a first outer diameter at the proximal end and a second outer diameter at the distal end.

10. The system of claim 9 wherein the first outer diameter has a diameter greater than or equal to the outer diameter of the introducer sheath.

11. The system of claim 9 wherein the second outer diameter has a diameter greater than or equal to the outer diameter of the introducer sheath.

12. The system of claim 9 wherein an angle between the first outer diameter and the second outer diameter is from about 30°

to about 60°

.

13. The system of claim 9 wherein an axial length of the proximal end at the first outer diameter is from about 1 mm to about 10 mm.

14. The system of claim 9 wherein an axial length of the distal end at the second outer diameter is from about 1 mm to about 10 mm.

15. The system of claim 9 wherein the first outer diameter is less than the second outer diameter.

16. The system of claim 15 wherein the first outer diameter is less than or equal to the inner diameter of the sheath.

17. The system of claim 9 wherein the first outer diameter is greater than the second outer diameter.

18. The system of claim 17 wherein the second outer diameter is less than or equal to the inner diameter of the sheath.

19. The system of claim 1 wherein the control tip further comprises a pressure port.

20. The system of claim 1 wherein said self-expandable member has a first wall thickness at the proximal end and a second wall thickness at the distal end.

21. The system of claim 20 wherein the first wall thickness is less than the second wall thickness.

22. The system of claim 20 wherein the first wall thickness is greater than the second wall thickness.

23. The system of claim 1 wherein the self-expandable member is filled with a compressible fluid.

24. The system of claim 23 wherein the compressible fluid is air.

25. The system of claim 1 wherein an airtight chamber is formed between the self-expandable member and the control tip.

26. A method for forming a self-expandable member, comprising

extruding a thermoplastic tube, the thermoplastic tube having a first end and a second end;

inserting said tube into a tooling cavity;

heating the tube;

extending the tube axially;

pressure forming the tube;

positioning the tube over a control tip body; and

securing the tube to the control tip body

forming an air-tight chamber between the control tip body and the tube, wherein the air-tight changer is responsive to pressure changes.

27. The method of claim 26 wherein said tube is flexible.

28. The method of claim 26 wherein said securing further comprises fusing the tube to the control tip body.

29. The method of claim 26 wherein said securing further comprises heat forming the tube to the control tip body.

30. The method of claim 26 wherein said securing comprises attaching the first end to the control tip body.

31. The method of claim 26 wherein said securing comprises attaching the second end to the control tip body.

32. A apparatus for forming a self-expandable member, comprising

means for extruding a thermoplastic tube, the thermoplastic tube having a first end and a second end;

means for inserting said tube into a tooling cavity;

means for heating the tube;

means for extending the tube axially;

means for pressure forming the tube;

means for positioning the tube over a control tip body; and

means for securing the tube to the control tip body

means for forming an air-tight chamber between the control tip body and the tube, wherein the air-tight changer is responsive to pressure changes.

33. The apparatus of claim 32 wherein said tube is flexible.

34. The apparatus of claim 32 wherein said means for securing further comprises means for fusing the tube to the control tip body.

35. The apparatus of claim 32 wherein said means for securing further comprises means for heat forming the tube to the control tip body.

36. The apparatus of claim 32 wherein said means for securing comprises means for attaching the first end to the control tip body.

37. The apparatus of claim 32 wherein said means for securing comprises means for attaching the second end to the control tip body.

38. A method for sealing a puncture in the wall of a pressurized vessicle, comprising:

inserting a flexible seal into an interior of the pressurize vessicle, the flexible seal having an air-tight chamber;

positioning a distal portion of the air-tight chamber within the interior of the pressurized vessicle; and

positioning a proximal portion of the air-tight chamber outside the pressurized vissicle interior.