Balloon method and apparatus for vascular closure following arterial catheterization

• US 20020133123A1
• Filed: 03/14/2001
• Published: 09/19/2002
• Est. Priority Date: 03/14/2001
• Status: Active Grant

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Zucker, Menachem
• Granted Patent: US 6,743,195 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• 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.

A method for hemostasis of an artery having a puncture after arterial catheterization is also disclosed.

Claims

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

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 said forward end of said flexible hollow shaft, said hemostasis device being arranged to be insertable into an artery via said catheter introducer.

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 hemostasis device being arranged to be insertable into an artery via said catheter introducer.

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.

41. A method for hemostasis of an artery having a puncture after arterial catheterization, said catheterization using a catheter introducer, the method comprising the steps of:

inserting into an artery a catheter introducer having a forward end;

following arterial catheterization and removal of a catheter from the catheter introducer, introducing into the artery via said catheter introducer, 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;

inflating the inflatable anchor balloon inside the artery, causing said inflatable anchor balloon to assume an inflated state;

retracting the hemostasis device relative to the catheter introducer, until said anchor balloon in said inflated state engages said forward end of said catheter introducer;

retracting said hemostasis device and said catheter introducer until said anchor balloon in said inflated state sealingly engages an inner wall surface of a wall of the artery about said catheter introducer;

thereafter retracting said catheter introducer such that the forward end thereof lies outside the wall of the artery, while said anchor balloon in said inflated state blocks blood flow from the artery;

inflating said peripheral balloon adjacent the forward end of the catheter introducer as it lies outside an outer surface of the wall of the artery, thereby causing the peripheral balloon to assume an inflated state;

deflating the inflatable anchor balloon;

thereafter, withdrawing said forward end of said flexible hollow shaft from said artery, while said peripheral balloon seals a region outside said artery and surrounding an aperture in said artery through which said forward end of said flexible shaft was withdrawn, allowing hemostasis to occur thereat; and

following hemostasis, deflating of said peripheral balloon and removal of said hemostasis device from the patient.

42. A method according to claim 41 and also comprising injecting a hemostatic agent via the hemostasis device to a location external of the artery.

43. A method according to claim 41 and wherein said inflating said peripheral balloon includes:

initially inflating said peripheral balloon; and

thereafter, further inflating said peripheral balloon sufficiently to cause said forward end of said flexible hollow shaft to be withdrawn completely from the wall of the artery and simultaneously to prevent blood flow from the artery through the artery wall.