Blood vessel occlusion device

• US 6,248,121 B1
• Filed: 07/23/1998
• Issued: 06/19/2001
• Est. Priority Date: 02/18/1998
• Status: Expired due to Term

• Current Assignee: Cardio Medical Solutions Incorporated
• Original Assignee: Cardio Medical Solutions Incorporated
• Inventors: Nobles, Anthony A.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/121,443
• Time in Patent Office: 1,062 Days
• Field of Search: 606/194, 606/195, 606/108, 606/192, 604/96, 604/97, 604/99, 604/100, 604/102, 604/915, 604/104
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A direct-access device with a thin-profile balloon member is used to occlude a blood vessel. The device is ideally suited for occluding a patient'"'"'s aorta during stopped-heart cardiac procedures. The device comprises a flexible, thin-profile balloon member which forms a balloon in combination with a tubular member, which inflates the thin-profile balloon member. Together, the balloon member and tubular member occlude a blood vessel. The balloon member is attached near the distal end of the tubular member. The width of the balloon member'"'"'s outer peripheral contact area, which contacts the inner wall of the blood vessel, is substantially narrower than the balloon member'"'"'s diameter. The balloon member is made of a low compliance material which prevents the balloon member from expanding by more than 40% radially and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape. The balloon member comprises at least one pair of internal ribs which support the structure of the balloon member and prevent the balloon member from expanding longitudinally by more than 50%. The balloon member with internal ribs may be formed by dipping a mandrel, with grooves or channels formed therein, a number of times into liquid polyethylene, polyurethane or other similar material. The tubular member comprises a first lumen which carries blood between the patient and an external medical device. Another lumen is used to inflate and deflate the thin profile balloon member. Other lumens are used to measure blood pressure, introduce cardioplegia solution or drugs, and/or compensate for over-inflation of the balloon member. The tubular member is preferably bent near the distal end to allow the balloon member to be directly introduced into the blood vessel.

Claims

1. A device for occluding a patient'"'"'s blood vessel through direct access of the blood vessel, said device comprising:

a flexible balloon member having an outer peripheral contact portion for coming in contact with an inner wall of the blood vessel during occlusion, said balloon member being formed of a limited compliance material which limits the expansion of the balloon member to between 1% and 40% radially and between 1% and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape, said balloon member having a diameter, said outer peripheral contact portion being substantially narrower in width than the diameter of the balloon member;

a tubular member, said balloon member being attached to the tubular member near a distal end of the tubular member, said tubular member comprising;

a first lumen extending axially within the tubular member, said first lumen adapted to carry blood between the patient and an external medical device; and

a second lumen extending axially within the tubular member, which conducts fluid to inflate and deflate the balloon member, said second lumen extending to an opening which coincides in position with an interior of the balloon member.

2. The device of claim 1, wherein the balloon member composed of a limited compliance material which limits the expansion of the balloon member to expanding from 1% to 40% radially and from 1% to 50% longitudinally after the balloon member is initially inflated under ambient pressure to itsa normal, unstretched shape.

3. The device of claim 1, wherein the balloon member comprises:

a first side wall extending between the outer peripheral contact portion and the tubular member;

a second side wall extending between the outer peripheral contact portion and the tubular member; and

at least one pair of structure support members extending through a space between the first and second side walls to limit the expansion of the balloon member during inflation.

4. The device of claim 3, wherein the structure support members limit longitudinal expansion of the balloon member.

5. The device of claim 3, wherein the structure support members comprise internal ribs which extend from the first and second side walls.

6. The device of claim 3, wherein the structure support members are formed from the same material as the first and second side walls.

7. The device of claim 3, wherein at least two pairs of structure support members are spaced at equal angular intervals within the balloon member.

8. The device of claim 1, wherein the tubular member has a bend formed therein proximal to the balloon member to facilitate introduction of the balloon member directly into the blood vessel.

9. The device of claim 8, wherein the bend is substantially ninety degrees.

10. The device of claim 1, wherein the balloon member is sized to fit a patient'"'"'s superior vena cava.

11. The device of claim 1, wherein the tubular member further comprises a blood pressure lumen extending axially within the tubular member, said blood pressure lumen being in fluid communication with a pressure sensor to monitor the blood pressure within the blood vessel.

12. The device of claim 11, wherein the blood pressure lumen and the pressure sensor are used to monitor the blood pressure within the blood vessel proximal to the balloon member.

13. The device of claim 11, wherein the blood pressure lumen and the pressure sensor are used to monitor the blood pressure within the blood vessel distal to the balloon member.

14. The device of claim 1, further comprising an inflation indicating device which indicates when the inflatable balloon is in contact with the inner wall of the blood vessel during occlusion, said inflation indicating device being fluidly coupled to the inflatable balloon.

15. The device of claim 14, wherein the inflation indicating device is a pressure meter which measures the pressure inside the inflatable balloon.

16. The device of claim 1, wherein the balloon member is sized to fit a patient'"'"'s aorta.

17. The device of claim 1, wherein the expansion of the balloon member is such that its width (L) does not expand to be more than 20% of its diameter (D).

18. The device of claim 1 wherein the balloon member comprises at least one indent along the outer peripheral contact portion which helps the balloon member maintain its position within the blood vessel.

19. The device of claim 18, wherein at least one indent is formed such that the outer peripheral contact portion of the balloon member is divided into at least two peaks.

20. The device of claim 19, wherein each of the two peaks comprises:

a first structure support member on a first internal side wall; and

a second structure support member on a second internal side wall, wherein the first member is attached to the second member.

21. The device of claim 18, wherein at least one indent extends around the entire outer peripheral contact portion of the balloon member.

22. The medical device of claim 1, wherein the limited compliance material limits the expansion of the balloon member to between 10% and 33% radially after the balloon member is initially inflated.

23. The medical device of claim 1, wherein the limited compliance material limits the expansion of the balloon member to between 10% and 40% longitudinally after the balloon member is initially inflated.

24. The medical device of claim 1, wherein the limited compliance material limits the expansion of the balloon member to between 10% and 33% radially and between 10% and 40% longitudinally after the balloon member is initially inflated.

25. The device of claim 1, wherein the expansion of the balloon member is such that its width (L) does not expand to be more than 50% of its diameter (D).

26. A device for occluding a patient'"'"'s blood vessel through direct access of the blood vessel, said device comprising:

a flexible balloon member having an outer peripheral contact area for coming in contact with an inner wall of the blood vessel during occlusion, said balloon member having a diameter, said outer peripheral contact area being substantially narrower in width than the diameter of the balloon member, said balloon member further comprising at least one pair of internal ribs which interconnect inner walls of the balloon member to limit the expansion of the balloon member during inflation, wherein the internal ribs prevent the balloon member from expanding by more than 10 to 50% longitudinally after the balloon member is initially inflated;

a tubular member which combines with the balloon member to form an inflatable balloon for occluding the blood vessel, said balloon member being attached near a distal end of the tubular member, said tubular member comprising;

a first lumen extending axially within the tubular member, said first lumen adapted to carry blood between the patient and an external medical device; and

a second lumen extending axially within the tubular member, said second lumen adapted to be used to inflate and deflate the balloon member, said second lumen extending to an opening which coincides in position with an interior of the balloon member.

27. A device for occluding a patient'"'"'s blood vessel through direct access of the blood vessel, said device comprising:

a flexible balloon member having an outer peripheral contact area for coming in contact with an inner wall of the blood vessel during occlusion, said balloon member being formed of a limited compliance material which allows the balloon member to expand between 1% and 40% radially and between 1% and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape, said balloon member having a diameter, said outer peripheral contact area being substantially narrower in width than the diameter of the balloon member;

a tubular member, said balloon member being attached to the tubular member near a distal end of the tubular member, said tubular member comprising;

a first lumen extending axially within the tubular member, said first lumen adapted to carry blood between the patient and an external medical device; and

a second lumen extending axially within the tubular member, which conducts fluid to inflate and deflate the balloon member, said second lumen extending to an opening which coincides in position with an interior of the balloon member; and

an inflation indicating device which indicates when the inflatable balloon is in contact with the inner wall of the blood vessel during occlusion, said inflation indicating device being fluidly coupled to the inflatable balloon, wherein the inflation indicating device is an over-inflation check balloon positioned outside the blood vessel, said over-inflation check balloon inflating when the inflatable balloon is in contact with the inner wall of the blood vessel during occlusion.

28. The device of claim 27, wherein the tubular member has a third lumen formed therein which fluidly connects the balloon member to the over-inflation check balloon.

29. A medical device comprising:

an elongated member having an inflation lumen formed therein; and

an inflatable balloon member attached to the elongated member and fluidly coupled to the inflation lumen, the balloon member comprising;

an outer peripheral contact wall for contacting an inner surface of a blood vessel upon inflation of said balloon member;

a first side wall extending between the outer peripheral wall and the elongated member;

a second side wall extending between the outer peripheral wall and the elongated member; and

a plurality of expansion limiting members extending through a space between the first and second side walls, said members attached to said side walls at respective locations spaced radially inwardly from the outer peripheral wall of said balloon member to inhibit separation of said side walls when said balloon member is inflated.

30. The device of claim 29, wherein the elongated member comprises a semi-rigid tube which is adapted to be inserted directly into a blood vessel to be occluded.

31. The device of claim 29, wherein the elongated member comprises a percutaneous catheter.

32. The device of claim 29, wherein the outer peripheral contact wall is substantially narrower in width than the diameter of the balloon member.

33. The device of claim 32, wherein the balloon member comprises at least one indent along the outer peripheral contact wall which helps the balloon member maintain its position within the blood vessel and reduces the surface area of the outer peripheral contact wall contacting the inner wall of the blood vessel.

34. The medical device of claim 29, wherein the members include first and second structure support members which protrude away from said first and second side walls, respectively, and join each other within the interior of said balloon member.

35. A medical device comprising:

an elongated member having an inflation lumen formed therein; and

an inflatable balloon member attached to the elongated member and fluidly coupled to the inflation lumen, the balloon member comprising internal ribs which interconnect inner walls of the balloon member to inhibit the overexpansion of the balloon member, wherein the internal ribs prevent the balloon from expanding by more than 50% longitudinally after the balloon is initially inflated.

36. The device of claim 35, wherein the internal ribs prevent the balloon from expanding by more than 10% longitudinally after the balloon is initially inflated.

37. A device for occluding a patient'"'"'s blood vessel through direct access of the blood vessel, said device comprising:

a flexible balloon member having an outer peripheral contact portion for contacting an inner surface of a wall of the blood vessel, said balloon member being formed of a material that allows said balloon member to stretch radially and longitudinally when inflated, said material having sufficiently limited compliance such that said balloon member maintains its overall shape during said stretching, said balloon member having a diameter (D) which is substantially greater than its length (L) when inflated;

a tubular member having said balloon member thereon, said tubular member sized for introduction through an opening in the wall of the blood vessel and into the vessel such that (i) a distal portion of said tubular member extends from said opening in said vessel wall to said balloon, and (ii) a proximal portion of said tubular member extends out of said opening in said vessel wall, wherein said proximal and said distal portions of said tubular member are both semi-rigid to facilitate such introduction, said tubular member comprising;

a first lumen extending axially within the semi-rigid tubular member, said first lumen adapted to carry blood between the patient and an external medical device; and

a second lumen extending axially within the semi-rigid tubular member which conducts fluid for inflating and deflating the balloon member.

38. The device of claim 37, wherein the tubular member has a substantially right angle bend formed therein in the semi-rigid material proximal to the balloon member to facilitate introduction of the balloon member directly into the blood vessel.

39. The device of claim 37, wherein the tubular member comprises a translucent material.

40. The device of claim 37, wherein the expansion of the balloon member is such that its width (L) does not expand to be more than 50% of its diameter (D).

41. The device of claim 37, wherein the expansion of the balloon member is such that its width (L) does not expand to be more than 20% of its diameter (D).

42. A device for occluding a patient'"'"'s blood vessel through direct access of the blood vessel, said device comprising:

a flexible balloon member having an outer peripheral contact portionf or coming in contact with an inner wall of the blood vessel during occlusion, said balloon member being formed of a limited compliance material which allows the balloon member to expand between 1% and 40% radially and between 1% and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape, said balloon member having a diameter, said outer peripheral contact portion being substantially narrower in width than the diameter of the balloon member; and

a tubular member, said balloon member being attached to the tubular member near a distal end of the tubular member, said tubular member comprising;

a first lumen extending axially within the tubular member, said first lumen adapted to carry blood between the patient and an external medical device; and

a second lumen extending axially within the tubular member, which conducts fluid to inflate and deflate the balloon member, said second lumen extending to an opening which coincides in position with an interior of the balloon member;

wherein the balloon member comprises;

a first side wall extending between the outer peripheral contact portion and the tubular member;

a second side wall extending between the outer peripheral contact portion and the tubular member; and

at least one pair of structure support members extending through a space between the first and second side walls to limit the expansion of the balloon member during inflation, wherein the structure support members are bonded together.

43. A device for occluding a patient'"'"'s blood vessel through direct access of the blood vessel, said device comprising:

a flexible balloon member having an outer peripheral contact area for coming in contact with an inner wall of the blood vessel during occlusion, said balloon member being formed of a limited compliance material which allows the balloon member to expand between 1% and 40% radially and between 1% and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape, said balloon member having a diameter, said outer peripheral contact area being substantially narrower in width than the diameter of the balloon member;

a tubular member, said balloon member being attached to the tubular member near a distal end of the tubular member, said tubular member comprising;

a first lumen extending axially within the tubular member, said first lumen adapted to carry blood between the patient and an external medical device; and

a second lumen extending axially within the tubular member, which conducts fluid to inflate and deflate the balloon member, said second lumen extending to an opening which coincides in position with an interior of the balloon member,

wherein the balloon member comprises at least one indent along the outer peripheral contact area which helps the balloon member maintain its position within the blood vessel; and

further comprising a solvent in the indent to substantially hold the indent in place after the balloon member is formed.