Balloon method and apparatus for vascular closure following arterial catheterization

• US 6,743,195 B2
• Filed: 03/14/2001
• Issued: 06/01/2004
• Est. Priority Date: 03/14/2001
• Status: Expired due to Fees

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Zucker, Menachem
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Lam, Ann Y.
• Application Number:
  US09/808,630
• Publication Number:
  US 20020133123A1
• Time in Patent Office: 1,175 Days
• Field of Search: 604/246, 604/96.01, 604/99.02, 604/101.01, 604/101.03, 604/101.04, 604/101.05, 604/102.01, 604/102.02, 604/102.03, 604/164.01, 604/164.02, 604/164.03, 604/164.08, 604/164.09, 604/164.11, 604/164.13, 604/264, 604/30, 604/35, 606/213, 606/214, 606/215
• US Class Current: 604/101.01
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Apparatus for hemostasis of an artery having a puncture after arterial catheterization, the apparatus includes a catheter introducer having a forward end and a hemostasis device including an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent the forward end of the flexible hollow shaft, the hemostasis device being arranged to be insertable into an artery via the catheter introducer.

Claims

1. Apparatus for hemostasis of an artery having a puncture after arterial catheterization, the apparatus comprising:

a hemostasis device including an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent said forward end of said flexible hollow shaft,

said inflatable anchor balloon and said inflatable peripheral balloon are mounted onto said elongate flexible hollow shaft and separately inflatable, dimensions of said balloons being different from each other, said anchor balloon having a cusp-type configuration when inflated.

2. Apparatus for hemostasis according to claim 1 and wherein said flexible hollow shaft comprises a central bore.

3. Apparatus for hemostasis according to claim 2 and wherein said flexible hollow shaft comprises a wall having an asymmetric cross section, including a relatively thick cross sectional region and a relatively thin cross-sectional region.

4. Apparatus for hemostasis according to claim 3 and wherein there is formed in said relatively thick cross sectional region a peripheral bore which extends to an peripheral balloon inflation location exterior of said wall and communicates thereat with an interior of said peripheral balloon.

5. Apparatus for hemostasis according to claim 4 and wherein said central bore extends to an anchor balloon inflation location at which it communicates with an interior of said inflatable anchor balloon.

6. Apparatus for hemostasis according to claim 2 and wherein said central bore extends to an anchor balloon inflation location communicating with an interior of said inflatable anchor balloon.

7. Apparatus for hemostasis according to claim 5 and wherein said anchor balloon and said central bore are configured such that when said anchor balloon is deflated it can be withdrawn into said central bore at said anchor balloon inflation location.

8. Apparatus for hemostasis according to claim 7 and wherein said anchor balloon is configured such that when it is inflated, it extends beyond the end of said flexible hollow shaft.

9. Apparatus for hemostasis according to claim 2 and wherein said anchor balloon and said central bore are configured such that when said anchor balloon is deflated it can be withdrawn into said central bore at said anchor balloon inflation location.

10. Apparatus for hemostasis according to claim 9 and wherein said anchor balloon is configured such that when it is inflated, it extends beyond the end of said flexible hollow shaft.

11. Apparatus for hemostasis according to claim 8 and also comprising a rod which is displaceable longitudinally inside and along said central bore and which extends through said flexible hollow shaft and terminates at a first end in a manually engageable handle portion and at a second end is attached to said anchor balloon.

12. Apparatus for hemostasis according to claim 2 and also comprising a rod which is displaceable longitudinally inside and along said central bore and which extends through said flexible hollow shaft and terminates in a manually engageable handle portion and at a second end is attached to said anchor balloon.

13. Apparatus for hemostasis according to claim 11 and wherein said rod comprises a multistrand cable surrounded by a plastic cylindrical seal and is attached at an extreme end thereof to an inner surface of said anchor balloon.

14. Apparatus for hemostasis according to claim 12 and wherein said rod comprises a multistrand cable surrounded by a plastic cylindrical seal and is attached at an extreme end thereof to an inner surface of said anchor balloon.

15. Apparatus for hemostasis according to claim 13 and also comprising a stopcock and associated conduit, communicating with an interior of a head element to which said flexible hollow shaft is fixed at a rearward end thereof.

16. Apparatus for hemostasis according to claim 15 and wherein said interior of said head element communicates with said central bore of said flexible hollow shaft and thus communicates with said interior of said anchor balloon at said anchor balloon inflation location.

17. Apparatus for hemostasis according to claim 14 and also comprising a stopcock and associated conduit, communicating with an interior of a head element to which said flexible hollow shaft is fixed at a rearward end thereof.

18. Apparatus for hemostasis according to claim 17 and wherein said interior of said head element communicates with said central bore of said flexible hollow shaft and thus communicates with said interior of said anchor balloon at said anchor balloon inflation location.

19. Apparatus for hemostasis according to claim 16 and also comprising a stopcock and associated conduit, communicating with an interior said peripheral bore and thus communicates with the interior of said peripheral balloon.

20. Apparatus for hemostasis according to claim 18 and also comprising a stopcock and associated conduit, communicating with an interior said peripheral bore and thus communicates with the interior of said peripheral balloon.

21. Apparatus for hemostasis of an artery having a puncture after arterial catheterization, the apparatus being adapted for use with a catheter introducer having a forward end and comprising:

a hemostasis device including an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent said forward end of said flexible hollow shaft,

said inflatable anchor balloon and said inflatable peripheral balloon are mounted onto said elongate flexible hollow shaft and separately inflatable, dimensions of said balloons being different from each other, said anchor balloon having a cusp-type configuration when inflated.

22. Apparatus for hemostasis according to claim 21 and wherein said flexible hollow shaft comprises a central bore.

23. Apparatus for hemostasis according to claim 22 and wherein said flexible hollow shaft comprises a wall having an asymmetric cross section, including a relatively thick cross sectional region and a relatively thin cross-sectional region.

24. Apparatus for hemostasis according to claim 23 and wherein there is formed in said relatively thick cross sectional region a peripheral bore which extends to an peripheral balloon inflation location exterior of said wall and communicates thereat with an interior of said peripheral balloon.

25. Apparatus for hemostasis according to claim 24 and wherein said central bore extends to an anchor balloon inflation location at which it communicates with an interior of said inflatable anchor balloon.

26. Apparatus for hemostasis according to claim 22 and wherein said central bore extends to an anchor balloon inflation location communicating with an interior of said inflatable anchor balloon.

27. Apparatus for hemostasis according to claim 25 and wherein said anchor balloon and said central bore are configured such that when said anchor balloon is deflated it can be withdrawn into said central bore at said anchor balloon inflation location.

28. Apparatus for hemostasis according to claim 27 and wherein said anchor balloon is configured such that when it is inflated, it extends beyond the end of said flexible hollow shaft.

29. Apparatus for hemostasis according to claim 22 and wherein said anchor balloon and said central bore are configured such that when said anchor balloon is deflated it can be withdrawn into said central bore at said anchor balloon inflation location.

30. Apparatus for hemostasis according to claim 29 and wherein said anchor balloon is configured such that when it is inflated, it extends beyond the end of said flexible hollow shaft.

31. Apparatus for hemostasis according to claim 28 and also comprising a rod which is displaceable longitudinally inside and along said central bore and which extends through said flexible hollow shaft and terminates at a first end in a manually engageable handle portion and at a second end is attached to said anchor balloon.

32. Apparatus for hemostasis according to claim 22 and also comprising a rod which is displaceable longitudinally inside and along said central bore and which extends through said flexible hollow shaft and terminates in a manually engageable handle portion and at a second end is attached to said anchor balloon.

33. Apparatus for hemostasis according to claim 31 and wherein said rod comprises a multistrand cable surrounded by a plastic cylindrical seal and is attached at an extreme end thereof to an inner surface of said anchor balloon.

34. Apparatus for hemostasis according to claim 32 and wherein said rod comprises a multistrand cable surrounded by a plastic cylindrical seal and is attached at an extreme end thereof to an inner surface of said anchor balloon.

35. Apparatus for hemostasis according to claim 33 and also comprising a stopcock and associated conduit, communicating with an interior of a head element to which said flexible hollow shaft is fixed at a rearward end thereof.

36. Apparatus for hemostasis according to claim 35 and wherein said interior of said head element communicates with said central bore of said flexible hollow shaft and thus communicates with said interior of said anchor balloon at said anchor balloon inflation location.

37. Apparatus for hemostasis according to claim 34 and also comprising a stopcock and associated conduit, communicating with an interior of a head element to which said flexible hollow shaft is fixed at a rearward end thereof.

38. Apparatus for hemostasis according to claim 37 and wherein said interior of said head element communicates with said central bore of said flexible hollow shaft and thus communicates with said interior of said anchor balloon at said anchor balloon inflation location.

39. Apparatus for hemostasis according to claim 36 and also comprising a stopcock and associated conduit, communicating with an interior said peripheral bore and thus communicates with the interior of said peripheral balloon.

40. Apparatus for hemostasis according to claim 38 and also comprising a stopcock and associated conduit, communicating with an interior said peripheral bore and thus communicates with the interior of said peripheral balloon.