Balloon catheter

• US 6,638,245 B2
• Filed: 02/28/2002
• Issued: 10/28/2003
• Est. Priority Date: 06/26/2001
• Status: Expired due to Term

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Miller, John, Pierce, Ryan, Aboytes, Maria, Dieck, Martin
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US10/085,589
• Publication Number:
  US 20020198492A1
• Time in Patent Office: 607 Days
• Field of Search: 604/96.01, 604/93.01, 604/164.01
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• 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 25/1027 Making of balloon catheters

Abstract

This is a balloon catheter having at least two lumens. One of the lumens is a large working lumen. The balloon catheter is especially useful as a guide catheter or micro catheter and may be used in a variety of therapeutic and diagnostic procedures. In particular, it has value in treating neurovascular embolic strokes in combination with other devices which are delivered to the stroke site through that working lumen. The remainder of the lumens typically are used to inflate and to deflate the balloon. The balloon or inflatable member be situated in a recess in the outer wall of the inventive catheter. Additionally, the distal end of the catheter past the balloon may be tapered. The catheter has a very low profile as compared to other catheters of the neurovascular balloon catheter genre. It may include other features such as variable stiffness along the axis of the device and anti-kinking components. The balloon may be compliant in nature. When intended for use in treating embolic stroke, the catheter may be a component of a kit including a foreign body or clot retriever. Further, amongst other procedures, the invention includes methods of temporarily blocking a vascular lumen, of removing neurovascular or peripheral emboli. Other procedures, where diagnosis or treatment is needed in a vascular space and a large working lumen is desired, are suitable procedures for the balloon catheter.

Claims

1. A balloon catheter comprising:

a first elongate polymeric tubular member having an outer surface, a proximal end, a distal end, a lumen extending between said distal and proximal ends, and a radially recessed region near the distal end;

a second elongate polymeric tubular member within the first elongate tubular member and having a working lumen and an outer surface defining an annular space between the first elongate tubular member and the outer surface of the second tubular member, said annular space being a fluid supply lumen; and

an inflatable member situated within said radially recessed region and not extending beyond the distal end of the first enlongate poloymeric tubular member, said inflatable member when deflated, providing said balloon catheter a substantially constant diameter commencing in a region proximally adjacent to the radially recessed region and continuing across the radially recessed region, and said inflatable member being fluid-connectable with said fluid supply lumen.

2. The balloon catheter of claim 1, wherein said second elongate tubular member comprises sections comprising materials having differing Durometer values.

3. The balloon catheter of claim 1, wherein said first elongate tubular member has a varying outer diameter.

4. The balloon catheter of claim 3, wherein said first elongate tubular member has a proximal section and a distal section having a smaller outer diameter than the proximal section and wherein the recessed region is in said distal section.

5. The balloon catheter of claim 4, wherein said first elongate tubular member has a varying inner diameter.

6. The balloon catheter of claim 5, wherein said first elongate tubular member has a substantially constant wall thickness.

7. The balloon catheter of claim 1, wherein said first elongate tubular member is tapered distal of said inflatable member and joined to said second elongate tubular member.

8. The balloon catheter of claim 1, wherein the recessed region commences with a proximal shoulder.

9. The balloon catheter of claim 8, wherein the recessed region terminates with a distal shoulder.

10. The balloon catheter of claim 8 wherein the proximal shoulder is the only shoulder of the recessed region.

11. The balloon catheter of claim 1, further comprising at least one marker band.

12. The balloon catheter of claim 11 wherein said at least one marker band is positioned on at least a portion of said inflatable member.

13. The balloon catheter of claim 12, wherein said at least one marker band is positioned completely on said inflatable member.

14. The balloon catheter of claim 1, wherein said substantially constant diameter is between one French (0.33 mm) and that of a blood vessel in the brain.

15. The balloon catheter of claim 14, wherein the balloon comprises a Silicone material.

16. The balloon catheter of claim 15, wherein said balloon is coated with a hydrophilic material.

17. The balloon catheter of claim 16, wherein said hydrophilic material comprises a hyaluronic salt.

18. The balloon catheter of claim 1, wherein said first elongate tubular member is discretely bonded to said second elongate tubular member in at least one location.

19. The balloon catheter of claim 4, wherein the recessed region commences with a proximal shoulder.

20. The balloon catheter of claim 19, wherein the recessed region terminates with a distal shoulder.

21. The balloon catheter of claim 1, wherein said recess is uncurved.

22. The balloon catheter of claim 1, wherein said balloon has varying wall thickness.

23. The balloon catheter of claim 1, wherein said inflatable member is non-spherically shaped when inflated.

24. The balloon catheter of claim 1, wherein said inflatable member is spherically-shaped when inflated.

37. The balloon catheter of claim 1 wherein the inflatable member is fluidly connectable with said fluid supply lumen via at least one aperture through the first elongate polymeric member.

38. The balloon catheter of claim 1 wherein said inflatable member is connected only to said first elongate polymeric tubular member.

39. The balloon catheter of claim 18 wherein the first elongate polymeric tubular member is bonded to the second elongate polymeric tubular member with an adhesive.

25. A balloon catheter comprising:

a first elongate polymeric tubular member having an outer surface, a proximal end, a distal end, a lumen extending between said distal and proximal ends, and a radially recessed region near the distal end;

a second elongate polymeric tubular member within the first elongate tubular member having a working lumen, a proximal end, a distal end and an outer surface defining an annular space between the first elongate tubular member and the outer surface of the second tubular member, said annular space being a fluid supply lumen, said second elongate polymeric tubular member further comprising a reinforcement layer beginning at said proximal end and terminating a distance proximal to said distal end of said second tubular member wherein said distance is greater or equal to 10 cm or less than 3 cm; and

an inflatable member having a proximal portion mounted to said radially recessed region of said first tubular member and a distal portion mounted to said second elongate tubular member at a location distal to said distal end of said first elongate member, said inflatable member being fluid-connectable with said fluid supply lumen.

26. The balloon catheter of claim 25, wherein said reinforcement layer is a braid.

27. The balloon catheter of claim 26, wherein said distance is 1 cm or less.

28. The balloon catheter of claim 25, wherein said inflatable member is stretched when in a deflated state.

29. The balloon catheter of claim 25, wherein said inflatable member is non-spherical shaped when inflated.

30. The balloon catheter of claim 25, wherein said second tubular member is fixed to said first tubular member in at least one location.

31. The balloon catheter of claim 30, wherein said inflatable member is elastic.

32. A balloon catheter comprising:

a first elongate polymeric tubular member having an outer surface, a proximal end, a distal end, a lumen extending between said distal and proximal ends, and a radially recessed region near the distal end;

a second elongate polymeric tubular member within the first elongate tubular member and having a working lumen, a proximal end, a distal end and an outer surface defining an annular space between the first elongate tubular member and the outer surface of the second tubular member, said annular space being a fluid supply lumen; and

an inflatable member having a proximal portion mounted to said radially recessed region of said first tubular member and a distal portion mounted to said second elongate tubular member at a location distal to said distal end of said first elongate member, said inflatable member being stretched when deflated and said inflatable member being fluid-connectable with said fluid supply lumen.

33. The balloon catheter of claim 32, wherein said inflatable member has a non-spherical shape when inflated.

34. The balloon catheter of claim 32, wherein said second tubular member is fixed to said first tubular member in at least one location.

35. The balloon catheter of claim 32, wherein said second tubular member comprises a braided reinforcement member, said reinforcement member extending from said proximal end to a point proximal to the distal end of the second tubular member, said point being 3 cm or less from said distal end of said second tubular member.

36. The balloon catheter of claim 33, wherein said non-spherical shape is oval.

40. A balloon catheter comprising:

a first elongate polymeric tubular member having an outer surface, a proximal end, a distal end, a lumen extending between said distal and proximal ends, and a radially recessed region near the distal end;

a second elongate polymeric tubular member within the first elongate tubular member and having a working lumen and an outer surface defining an annular space between the first elongate tubular member and the outer surface of the second tubular member, said annular space being a fluid supply lumen; and

an inflatable member situated within said radially recessed region and not extending beyond the distal end of the first elongate polymeric tubular member, sealed at each of its ends only to said first elongate polymeric tubular member, wherein said inflatable member, when deflated, providing said balloon catheter a substantially constant diameter commencing in a region proximally adjacent to the radially recessed region and continuing axially across the radially recessed region, and said inflatable member being fluid-connectable with said fluid supply lumen via at least one aperture through the first elongate polymeric member.

41. The balloon catheter of claim 40 wherein said recessed region comprises a proximal shoulder and a distal shoulder.

42. The balloon catheter of claim 40 wherein said recessed region comprises only a proximal shoulder.

43. The balloon catheter of claim 40 wherein the first elongate polymeric tubular member is bonded to the second elongate polymeric tubular member.

44. The balloon catheter of claim 43 wherein the first elongate polymeric tubular member is bonded to the second elongate polymeric tubular member with an adhesive.

45. The balloon catheter of claim 40 wherein the second tubular member extends beyond the distal end of the first tubular member.