Enhanced catheter with alignment means

• US 6,740,104 B1
• Filed: 07/31/2000
• Issued: 05/25/2004
• Est. Priority Date: 05/15/1998
• Status: Expired due to Term

• Current Assignee: X Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Solar, Ronald J., Lieber, Glen L.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/629,768
• Time in Patent Office: 1,394 Days
• Field of Search: 604/500, 604/509, 604/510, 604/95.04, 604/96.01, 604/103.04, 604/103.05, 604/103.09, 604/264, 604/265-266, 604/523, 604/524, 604/525, 604/526-527, 604/528, 604/921, 606/191-194
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• 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 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon dilatation system is comprised of an elongated flexible advancement member which terminates in a tubular tracking member slidable over a guidewire. An inflatable balloon has proximal and distal ends, the proximal end communicating with an inflation channel, and the distal end attaching to the tracking member. The balloon portion is coextensive with but not attached to the advancement member. An alignment member aligns the advancement member and the inflation channel. Other embodiments relate to delivery of stents or other medical instrumentalities.

Claims

1. A balloon dilatation catheter system comprising:

a flexible elongated advancement member having a distal end,

a tracking member having a proximal end and a distal end, said tracking member being adapted to slide over a guidewire and being fixedly attached to the distal end of the advancement member,

an inflation channel, and

an inflatable dilatation balloon having proximal end and distal end, the proximal end of the balloon being in fluid communication with the inflation channel,

wherein the distal end of the balloon is attached to the tracking member, an alignment member aligns the advancement member and the inflation channel in the longitudinal direction, and the advancement member is attached to or integral with the alignment member.

2. The catheter system of claim 1, wherein the tracking member comprises two or more lumens.

3. The catheter system of claim 1, wherein the dilatation balloon is attached to the distal end of the tracking member.

4. The catheter system of claim 1, wherein the dilatation balloon is attached to the proximal end of the tracking member.

5. The catheter system of claim 1, wherein the tracking member has a lubricious coating.

6. The catheter system of claim 1, wherein the tracking member is formed integral with the dilatation balloon.

8. The catheter system of claim 1 or 7, wherein the inflation channel is substantially coextensive with the advancement member.

9. The catheter system of claim 1 or 7, wherein the inflation channel is in a spiral configuration around the advancement member.

10. The catheter system of claim 1 or 7, wherein the advancement member comprises a flexible wire or hypotube.

11. The catheter system of claim 1 or 7, wherein the advancement member is rigid at its proximal end and increasingly more flexible as it extends distally.

12. The catheter system of claim 1 or 7, wherein the inflation channel is collapsible or noncollapsible.

13. The catheter system of claim 1 or 7, wherein the dilatation balloon or the inflation channel, or both, have a wire reinforcement.

14. The catheter system of claim 1 or 7, wherein the dilatation balloon and the inflation channel are formed integrally.

15. The catheter system of claim 1 or 7, wherein the inflation channel is attached to the advancement member at at least one point.

16. The catheter system of claim 1 or 7, which also comprises a torquer attached to the proximal end of the advancement member.

17. The catheter system of claim 1 or 7, wherein the inflation channel is not attached to the advancement member.

18. The catheter system of claim 1 or 7, wherein the balloon and/or the inflation channel are attached to the advancement member.

19. The catheter system of claim 1, wherein the advancement member is attached to the inner surface of the alignment member.

20. The catheter system of claim 1, wherein the advancement member is attached to the outer surface of the alignment member.

21. The catheter system of claim 1 or 7, wherein the alignment member is a hypotube.

38. The catheter system of claim 1, wherein the advancement member is attached to the inner surface of the alignment member.

39. The catheter system of claim 1, wherein the advancement member is attached to the outer surface of the alignment member.

7. A balloon dilatation catheter system comprising:

a flexible elongated advancement member having a distal end,

a dilatation balloon having a proximal end and a distal end, and

an inflation channel, the proximal end of the balloon being in fluid communication with the inflation channel,

wherein the distal end of the balloon is attached to the distal end of the advancement member, an alignment member aligns the advancement member and the inflation channel in the longitudinal direction, and the advancement member is attached to or integral with the alignment member.

22. A method of positioning the distal end of a dilatation system at a desired location within a patient'"'"'s body, which comprises the steps of:

(a) advancing a first dilatation system comprising;

a flexible elongated advancement member having a distal end,

a tracking member having a proximal end and a distal end, said tracking member being adapted to slide over a guidewire and being fixedly attached to the distal end of the advancement member,

an inflation channel, and

an inflatable dilatation balloon having proximal end and distal end, the proximal end of the balloon being in fluid communication with the inflation channel,

wherein the distal end of the balloon is attached to the tracking member, and an alignment member aligns the advancement member and the inflation channel in the longitudinal direction,

over a guidewire through a corporeal lumen so that the distal end of said dilatation system is positioned at a desired location, and

(b) advancing another dilation system or other medical device over the guidewire to a position adjacent to said first dilation system.

23. A medical delivery system comprising:

a flexible elongated advancement member having a distal end,

a tracking member having a proximal end and a distal end, said tracking member being adapted to slide over a guidewire and being fixedly attached to the distal end of the advancement member, and

a medical instrumentality having proximal end and distal end, the proximal end of the instrumentality being in communication with a source,

wherein the distal end of the medical instrumentality is attached to the tracking member, an alignment member aligns the advancement member and any communication member connected to the medical instrumentality, and the advancement member is attached to or integral with the alignment member.

24. The delivery system of claim 23, wherein the tracking member comprises two or more lumens.

25. The delivery system of claim 23, wherein the medical instrumentality is attached to the distal end of the tracking member.

26. The delivery system of claim 23, wherein the medical instrumentality is attached to the proximal end of the tracking member.

27. The delivery system of claim 23, wherein the tracking member has a lubricious coating.

28. The delivery system of claim 23, wherein the tracking member is formed integral with the medical instrumentality.

30. The delivery system of claim 23 or 29, wherein the communication member is substantially coextensive with the advancement member.

31. The delivery system of claim 23 or 29, wherein the communication member is in a spiral configuration around the advancement member.

32. The delivery system of claim 23 or 29, wherein the advancement member comprises a flexible wire or hypotube.

33. The delivery system of claim 23 or 29, wherein the advancement member is rigid at its proximal end and increasingly more flexible as it extends distally.

34. The delivery system of claim 23 or 29, wherein the medical instrumentality and the communication member are formed integrally.

35. The delivery system of claim 23 or 29, wherein the communication member is attached to the advancement member at at least one point.

36. The delivery system of claim 23 or 29, wherein the communication member is not attached to the advancement member.

37. The delivery system of claim 23 or 29, wherein the medical instrumentality and/or the communication member are attached to the advancement member.

40. The delivery system of claim 23 or 29, wherein the alignment member is a hypotube.

29. A medical delivery system comprising:

a flexible elongated advancement member having a distal end,

a medical instrumentality having a proximal end and a distal end, and

a communication member, the proximal end of the medical instrumentality being in communication with the communication member,

wherein the distal end of the medical instrumentality is attached to the distal end of the advancement member, an alignment member aligns the advancement member and the communication member in the longitudinal direction and the advancement member is attached to or integral with the alignment member.

41. A method of positioning the distal end of a medical instrumentality at a desired location within a patient'"'"'s body, which comprises the steps of:

(a) advancing a delivery system comprising;

a flexible elongated advancement member having a distal end,

a tracking member having a proximal end and a distal end, said tracking member being adapted to slide over a guidewire and being fixedly attached to the distal end of the advancement member, and

a first medical instrumentality having proximal end and distal end, the proximal end of the instrumentality being in communication with a source,

wherein the distal end of the medical instrumentality is attached to the tracking member and an alignment member aligns the advancement member and any communication member connected to the first medical instrumentality,

over a guidewire through a corporeal lumen so that the first medical instrumentality is positioned at a desired location, and

(b) advancing a second medical instrumentality distally over the guidewire to a position adjacent to the delivery system.

42. A method of positioning the distal end of a dilatation system at a desired location within a patient'"'"'s body, which comprises the steps of:

(a) advancing a dilatation system comprising;

a flexible elongated advancement member having a distal end,

a dilatation balloon having a proximal end and a distal end, and

an inflation channel, the proximal end of the balloon being in fluid communication with the inflation channel,

wherein the distal end of the balloon is attached to the distal end of the advancement member and an alignment member aligns the advancement member and the inflation channel in the longitudinal direction,

over a guidewire through a corporeal lumen so that the distal end of said dilatation system is positioned at a desired location, and

(b) advancing another dilatation system or other medical device over the guidewire to a position adjacent to the catheter system.

43. A method of positioning the distal end of a medical instrumentality at a desired location within a patient'"'"'s body, which comprises the steps of:

(a) advancing a delivery system comprising;

a flexible elongated advancement member having a distal end,

a first medical instrumentality having a proximal end and a distal end, and

a communication member, the proximal end of the medical instrumentality being in communication with the communication member,

wherein the distal end of the first medical instrumentality is attached to the distal end of the advancement member and an alignment member aligns the advancement member and the communication member in the longitudinal direction,

over a guidewire through a corporeal lumen so that the distal end of said dilatation system is positioned at a desired location, and

(b) advancing a second medical instrumentality over the guidewire to a position adjacent to the delivery system.