Insertable balloon with curved support

• US 4,943,275 A
• Filed: 10/14/1988
• Issued: 07/24/1990
• Est. Priority Date: 10/14/1988
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed Limited Partnership
• Inventors: Stricker, Saul
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/257,752
• Time in Patent Office: 648 Days
• Field of Search: 604/96-103, 604/344, 604/281, 600/18, 128/344, 606/192, 606/194
• US Class Current: 600/18
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance

Abstract

A balloon assembly has an intrinsic curvature adapted to a passage in a blood vessel, and is straightened by a removable stiff member extending within the catheter to facilitate insertion along the passage. When the balloon is at a curved portion of the passage, the stiff member is retracted, allowing the balloon and adjacent support to conform to the curved passage and advance further without trauma to the vessel. The curved balloon may be stably positioned in a curved arterial passage and pumped with a pulsatile inflation source.

Claims

1. An insertable balloon assembly comprising

a balloon having first and second ends,

a balloon supporting structure extending between the first and second ends of the balloon which maintains the balloon longitudinally extended to prevent collapse of the balloon, and imparting a curvature to said balloon conforming to a curved arterial passage such that the balloon remains stably positioned when pumping in the curved passage,

an inflation catheter having a first end with a curvature matching said supporting structure connected to said balloon second end and extending to a handle assembly which is thereby interconnected with the balloon, said supporting structure defining an inner lumen extending in said catheter for receiving a straightening member inserted through said handle which straightens the balloon for insertion.

2. An assembly according to claim 1, further comprising a straightening member adapted for insertion through said catheter to straighten said supporting structure for insertion of the balloon along a path in a blood vessel.

3. An assembly according to claim 2, wherein said balloon supporting structure has a curved portion with a characteristic radius of curvature in the range of approximately two to five centimeters.

4. An assembly according to claim 2, wherein a curved portion of said supporting structure extends for at least the full length of the balloon.

5. An assembly according to claim 4, wherein said curved portion extends for approximately twice the length of the balloon.

6. An assembly according to claim 4, wherein said curved portion approximately conforms to the curvature of the aortic arch.

7. An assembly according to claim 1, wherein said balloon assembly is a double lumen intra aortic balloon pump assembly.

8. An assembly according to claim 7, wherein said supporting structure conforms to the curvature of the aortic arch.

9. An assembly according to claim 7, wherein said supporting structure includes at least a portion of a fluids sampling tube defining an inner lumen of the double lumen balloon pump assembly.

10. An assembly according to claim 9, wherein the supporting structure further includes at least a portion of the inflation catheter.

11. An assembly according to claim 7, further comprising a straightening member adapted for removable insertion through said catheter to straighten said supporting structure for enabling insertion of the balloon along a path in a blood vessel.

12. An assembly according to claim 11, wherein said supporting structure conforms to the curvature of the aortic arch, such that by withdrawing the straightening member the balloon assumes a curved shape to advance along the aortic arch.

14. A method according to claim 11, wherein step (iv) includes the step of partially withdrawing the straightening member while simultaneously advancing the balloon along the passage.

15. A method according to claim 11, wherein the steps of advancing the balloon advances the balloon to a site past the aortic arch.

13. A method of inserting a balloon along a passage in a blood vessel, such method comprising the steps of

(i) providing a curved balloon support which imparts a curvature to the balloon,

(ii) providing a straightening member, insertable within said balloon,

(iii) inserting the straightening member to straighten the curved balloon support and thereby straighten the balloon for advancing the balloon a first distance along the passage, and

(iv) at least partially withdrawing the straightening member to permit curving of the support so that the balloon assumes a curvature and advancing the balloon a further distance to position the balloon in a pumping locus located in a curved portion of the passage, and wherein said curved support conforms to said curved passage so that the balloon remains stably positioned during pumping.

16. An insertable balloon assembly comprising

a balloon having first and second ends,

a curved balloon support coupled to the first end of the balloon and extending through the balloon to the second end, said balloon support maintaining said balloon longitudinally extended to prevent collapse of the balloon and imparting a curvature to said balloon adapting the balloon to a curved arterial passage, said support having a central lumen,

an inflation catheter coupled to the second end of the balloon and having a curvature substantially matching the balloon support at said second end,

a handle assembly connected to said catheter, and

straightening means insertable through said handle and catheter in the lumen of the support to the balloon for straightening said balloon support so that the balloon may be inserted along an arterial passage.

17. An insertable balloon assembly according to claim 16, wherein the balloon support imparts a curvature to the balloon such that the balloon remains stably positioned in the curved arterial passage during pumping.

18. An insertable balloon assembly according to claim 17, wherein said support has a curvature conforming to the aortic arch.