Steerable dilatation catheter

• US 5,449,343 A
• Filed: 08/11/1988
• Issued: 09/12/1995
• Est. Priority Date: 07/30/1985
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Tremulis, William S., Samson, Wilfred J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US07/231,215
• Time in Patent Office: 2,588 Days
• Field of Search: 604/95-103, 604/49, 604/53, 128/344, 128/348.1, 600/18, 606/192, 606/194
• US Class Current: 604/95.01
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• 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 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A low-profile steerable dilatation catheter for angioplasty procedures which has an inflated balloon on the distal end with little or no tendency to wrap on itself when the catheter is advanced through a patient'"'"'s vascular system. The catheter comprises an elongated tubular member which is longitudinally relatively flexible but diametrically relatively rigid, a guide extension secured to the distal end of the elongated tubular member, and an inflatable balloon secured on the proximal end thereof to the distal end of the elongated tubular member and on the distal end directly or indirectly to the guide member or the tubular member and an elongated flexible member such as a helical coil secured to the guide extension distally of the balloon. The elongated tubular member is preferably a hypotube of stainless steel or nitinol.

Claims

1. A steerable dilatation catheter comprising:

a) an elongated, torquable member including;

an elongated, tubular member formed of high-strength material having proximal and distal ends and an inner lumen extending therein;

an elongated flexible guide element having proximal and distal ends, and being secured its proximal end to the distal end of the elongated tubular member;

b) an inflatable balloon having proximal and distal ends with the proximal and distal ends secured to the elongated torquable member to prevent relative rotational movement between the proximal and distal ends of the balloon and an interior in fluid communication with the inner lumen extending within the elongated tubular member, with a distal portion of the elongated flexible guide element extending out the distal end of the balloon;

c) an elongated flexible member having a proximal end and a distal end including a distal tip and being disposed about the distal portion of the guide element which extends out the distal end of the balloon; and

d) torque means on the proximal end of the torquable member to axially rotate the torquable member.

2. The steerable dilatation catheter of claim 1 wherein the elongated flexible member is a helical coil.

3. The steerable dilatation catheter of claim 1 wherein a smooth rounded plug is formed in the distal tip of the flexible member.

4. The steerable dilatation catheter of claim 3 wherein the distal end of the guide element is secured to the rounded plug.

5. The steerable dilatation catheter of claim 3 wherein the distal end of the guide element terminates short of the rounded plug.

6. The steerable dilatation catheter of claim 5 wherein the distal end of the guide element is secured to the flexible member at an intermediate location between the proximal and distal ends thereof.

7. The steerable dilatation catheter of claim 6 wherein a shaping ribbon is secured at the proximal end thereof to the flexible member at the intermediate location and at the distal end thereof to the rounded plug.

8. The steerable dilatation catheter of claim 7 wherein the shaping ribbon is formed of a metal selected from the group consisting of tungsten and alloys thereof and stainless steel.

9. The steerable dilatation catheter of claim 1 wherein the elongated tubular member is longitudinally relatively flexible but diametrically relatively rigid.

10. The steerable dilatation catheter of claim 9 wherein the elongated tubular member is a metal selected from the group consisting of stainless steel and nitinol.

11. The steerable dilatation catheter of claim 1 wherein a flexible plastic tube is disposed about the elongated tube formed of high-strength material and is sealingly secured about the periphery thereof at a location proximal to the balloon and wherein one or more inlet ports are provided in the elongated tube formed of high-strength material proximally of the location where the flexible plastic tube is secured.

12. The steerable dilatation catheter of claim 1 having the profile less than 0.02 inch.

13. The steerable dilatation catheter of claim 1 wherein the balloon is formed from a plastic material selected from the group consisting of polyethylene, polyvinylchloride, and polyethylene terephthalate.

14. The steerable dilatation catheter of claim 2 wherein at least a distal portion of the coil is formed of radiopaque metal.

15. The steerable dilatation catheter of claim 1 wherein the torque means is secured to the proximal end of the elongated tube.

16. The steerable dilatation catheter of claim 15 wherein the torque means is a removable hub.

17. The steerable dilatation catheter of claim 1 including means to vent air from the interior of the balloon during the inflation thereof with inflating liquid.

18. The steerable dilatation catheter of claim 17 wherein the venting means is a porous body disposed between the distal end of the balloon and the guide element.

19. The steerable dilatation catheter of claim 18 wherein the porous body is formed of polypropylene.

20. The steerable dilatation catheter of claim 1 wherein the tubular member extends through the interior of the balloon and the distal end of the balloon is sealed about the distal end of the tubular member.

21. The steerable dilatation catheter of claim 20 wherein the portion of the tubular member extending through the balloon is provided with a plurality of slots.

22. The steerable dilatation catheter of claim 21 wherein the slots are axially offset from one another by at least 45°

.

23. The steerable dilatation catheter of claim 21 wherein the slots are cut through at least half the diameter of the tube.

24. The steerable dilatation catheter of claim 21 wherein the width of the slots range from about 0.01 to 0.03 inch and the distance between the slots ranges from about 0.02 to 0.08 inch.

25. The steerable dilatation catheter of claim 1 wherein the flexible member is an elongated body of flexible plastic.

26. A steerable dilatation catheter comprising;

a) an elongated torquable member including,

an elongated, tubular element formed of high-strength material having proximal and distal extremities and an inner lumen extending along the length thereof in fluid communication with at least one inflation port for inflation fluid provided in the distal extremity thereof, and

an elongated guide element secured to the distal extremity of the elongated tubular element;

b) an inflatable balloon having proximal and distal ends and an interior and being secured at both the proximal end and distal ends thereof to the elongated torquable member to prevent the relative rotational movement therebetween with the interior of the inflatable balloon being in fluid communication with the inner lumen of the elongated tubular member through at least one discharge port therein;

c) an elongated flexible member disposed about a portion of the elongated guide element which extends distally of the balloon; and

d) means on the proximal extremity of the torquable member to axially rotate the torquable member.

27. A balloon catheter, comprising:

an elongate hollow, thin wall, tube having a lumen extending therethrough from a proximal end to a distal end;

a hollow, flexible torque transmitting shaft having a first end connected to the distal end of the tube and having a flow lumen therethrough which is in communication with the lumen of the tube;

an elongate core member extending distally from a second end of the shaft; and

an inflatable balloon surrounding the core member and having a proximal end bonded to the second end of the shaft and a distal end bonded to the core member, an interior of the balloon being in communication with the flow lumen.

28. A balloon catheter comprising:

a main shaft having a first inflation lumen extending therethrough from a proximal end to a distal end;

a secondary shaft having a proximal end connected to the distal end of the main shaft and having a second inflation lumen extending therethrough from the proximal end to a distal end;

the second inflation lumen being connected to the first inflation lumen, the secondary shaft having greater flexibility than and substantially similar torque transmitting characteristics to the main shaft;

an elongated core member extending distally from the distal end of the secondary shaft; and

an inflatable balloon surrounding the core member and having a proximal end connected to the distal end of the secondary shaft, a distal end connected to the core member, and an interior in communication with the second inflation lumen.

29. A method of dilating a stenosis within the arterial system of a patient comprising:

a) introducing into the patient'"'"'s vasculature a low-profile steerable dilatation catheter comprising;

an elongated tubular member formed of high-strength material having proximal and distal extremities, at least one discharge port in the distal extremity and an inner lumen extending therein in fluid communication with at least one discharge port in the distal extremity,

an elongated flexible guide element having proximal and distal ends and being secured by its proximal end to the distal extremity of the elongated tubular member,

an inflatable balloon having proximal and distal ends and being disposed about the elongated flexible guide element, with the proximal end of the balloon secured to the distal extremity of the elongated member proximally of at least one discharge port therein to facilitate the passage of inflation fluid from the inner lumen of the elongated tubular member into the interior of the inflatable balloon and the distal end of the balloon sealingly secured about the elongated flexible guide element to prevent loss of inflation fluid and to prevent relative rotational movement between the proximal and distal ends of the balloon,

an elongated flexible member disposed about and secured to the elongated flexible guide element and extending distally of the balloon, and

torque means, including a removable hub, to axially rotate the elongated tubular member and the elongated flexible guide element, secured to the proximal end of the elongated tubular member which adapted to be connected to a source of inflation fluid;

b) advancing the catheter through the patient'"'"'s vasculature until the balloon crosses a stenosis;

c) inflating the balloon on the distal end of the catheter to dilate a stenosis;

d) deflating the balloon;

e) removing the removable hub in the proximal end of the elongated tubular member;

f) securing an exchange wire to the proximal end of the elongated tubular member;

g) advancing over the exchange and elongated tubular member a conventional dilatation catheter having a dilatation balloon on the distal portion thereof with an inflated diameter larger than the inflated diameter of the low-profile steerable catheter until the balloon on the conventional dilatation catheter is disposed across the stenosis; and

h) inflating the balloon on the conventional dilatation catheter to further dilate the previously dilated stenosis.