Rapidly exchangeable coronary catheter

• US 5,980,486 A
• Filed: 07/20/1993
• Issued: 11/09/1999
• Est. Priority Date: 01/30/1989
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Arterial Vascular Engineering Incorporated (Medtronic Plc)
• Inventors: Enger, Christine D.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/095,036
• Time in Patent Office: 2,303 Days
• Field of Search: 604/96-103, 604/51, 604/54, 604/164, 604/171, 606/192, 606/194
• US Class Current: 604/103.04
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A rapidly exchangeable catheter for use in the coronary arteries includes an elongate relatively stiff proximal segment that defines an inflation lumen, an intermediate, shorter segment formed from a more flexible plastic material and having two lumens, and a third, single lumen distal segment. A balloon or other instrumentality adapted to operate in a coronary artery is mounted to the distal region of the catheter. The intermediate and distal segments include a guidewire lumen by which the catheter may be advanced along a guidewire. The proximal segment may include an inflation lumen when the operating instrumentality at the distal end of the catheter is a balloon. The intermediate and distal segments of the catheter are of a length of between about 35 to 45 cm such that when the catheter is advanced into the most remote distal portions of the coronary anatomy, the flexible plastic intermediate and distal segments will extend over the aortic arch of the patient thereby containing the guidewire over the aortic arch and maintaining the juncture of the relatively stiff proximal segment and the more flexible intermediate segment proximally of the aortic arch. The relatively stiff proximal section thus extends generally along a straight line from the femoral artery into the descending aorta but not so far as into the aortic arch. Buckling of the catheter is avoided so that the catheter is more easily manipulated.

Claims

1. A readily exchangeable balloon dilatation catheter comprising:

an elongated, high strength proximal tubular member which is formed of hypotubing, which has proximal and distal ends, and which has an inner lumen extending therein;

a flexible distal tubular member which is secured to the distal end of the high strength proximal tubular member, which has an inflation lumen extending longitudinally therein with a proximal end in fluid communication with the inner lumen of the high strength proximal tubular member and a distal end with an inflation port therein;

an inflatable, relatively inelastic dilatation balloon on the distal tubular member having a distal end sealingly bonded about the distal end of the distal tubular member and an interior which is in fluid communication with the inflation lumen through the inflation port thereof; and

,

the flexible distal tubular member having a guidewire receiving lumen extending longitudinally between a first guidewire port in the proximal end thereof and a distal guidewire port in the distal end thereof.

2. A readily exchangeable balloon dilatation catheter comprising:

an elongated, high strength proximal tubular member which is formed of hypotubing, which has proximal and distal ends, and which has an inner lumen extending therein;

a flexible distal tubular member which is secured to the distal end of the high strength proximal tubular member, which has an inflation lumen extending longitudinally therein with a proximal end in fluid communication with the inner lumen of the high strength proximal tubular member and a distal end with an inflation port therein;

an inflatable, relatively inelastic dilatation balloon on the distal tubular member having a distal end sealingly bonded about the distal end of the distal tubular member and an interior which is in fluid communication with the inflation lumen through the inflation port thereof; and

,

the flexible distal tubular member having a guidewire receiving lumen extending longitudinally between a first guidewire port in the proximal end thereof and a distal guidewire port in the distal end thereof, the proximal guidewire port being spaced longitudinally from the distal port in the distal end a distance substantially greater than the length of the dilatation balloon.

3. A readily exchangeable balloon dilatation catheter comprising:

an elongated, high strength proximal tubular member which is formed of hypotubing, which has proximal and distal ends, and which has an inner lumen extending therein;

a flexible distal tubular member which is secured to the distal end of the high strength proximal tubular member, which has an inflation lumen extending longitudinally therein with a proximal end in fluid communication with the inner lumen of the high strength proximal tubular member and a distal end with an inflation port therein;

an inflatable, relatively inelastic dilatation balloon on the distal tubular member having a distal end sealingly bonded about the distal end of the distal tubular member and an interior which is in fluid communication with the inflation lumen through the inflation port thereof; and

,

the flexible distal tubular member having a guidewire receiving lumen extending longitudinally between a first guidewire port in the proximal end thereof and a distal guidewire port in the distal end thereof, the guidewire receiving lumen being sufficiently long so that when the dilatation catheter is inserted through a guiding catheter in an angioplasty procedure, the first guidewire port is disposed within the guiding catheter, whereby the portion of a guidewire extending out the first guidewire port is disposed within the guiding catheter during the angioplasty procedure.

4. A readily exchangeable balloon dilatation catheter comprising:

an elongated, high strength proximal tubular member which is formed of hypotubing, which has proximal and distal ends, and which has an inner lumen extending therein;

a flexible distal tubular member which is secured to the distal end of the high strength proximal tubular member, which has an inflation lumen extending longitudinally therein with a proximal end in fluid communication with the inner lumen of the high strength proximal tubular member and a distal end with an inflation port therein, and which has a guidewire receiving lumen extending longitudinally between a first guidewire port in the proximal end thereof and a distal guidewire port in the distal end thereof, the proximal guidewire port being spaced longitudinally at least about 10 cm from the distal port in the distal end; and

an inflatable, relatively inelastic balloon on the distal tubular member having a distal end sealingly bonded about the distal end of the distal tubular member and an interior which is in fluid communication with the inflation lumen through the inflation port thereof.

5. A balloon dilatation catheter for percutaneous transluminal coronary angioplasty, the catheter having a proximal end and a distal end and comprising:

an elongate stiff proximal segment, formed of hypotubing, having an inflation lumen extending therethrough;

an intermediate elongate plastic catheter segment attached to the distal end of the proximal segment, and having two lumens formed therethrough including a first lumen in fluid flow communication with the inflation lumen of the proximal segment to define a continuation of the inflation lumen, the inflation lumen in the intermediate segment terminating in an outlet port, the intermediate segment having a second, guidewire lumen extending parallel to the first lumen and being adapted to receive a guidewire, the guidewire lumen having a proximal opening in the region of the juncture of the intermediate and proximal segments;

the proximal segment being smaller in diameter than the intermediate segment and being substantially stiffer than the intermediate segment, the proximal segment having sufficient column strength to resist buckling when advanced through the patient'"'"'s arteries;

a distal segment attached to the distal end of the intermediate segment and defining an elongate lumen in communication with and being a continuation of the distal end of the guidewire lumen of the intermediate segment, and terminating, at its distal tip, in a distal outlet;

the guidewire lumen through the intermediate and distal segments being open only at said proximal opening and said distal outlet, the intermediate and distal segments completely and continuously circumscribing the guidewire lumen to preclude a guidewire from exiting the guidewire lumen laterally between the proximal opening and the distal outlet;

a dilatation balloon having proximal and distal ends, the distal end of the balloon being mounted on the distal segment and the proximal end of the balloon being mounted on the intermediate segment, the interior of the balloon being in communication with the outlet port of the inflation lumen;

whereby when a guide wire is received in the guidewire lumen the catheter will having continuous column support fully along its length from the proximal end of the proximal segment to the distal outlet of the distal segment.

6. A balloon dilatation catheter as defined in claim 5 wherein the distal segment is of smaller diameter and is more flexible than the intermediate segment.

7. A balloon dilatation catheter as defined in any of claims 5 or 6 wherein the distal and intermediate segments extend over a combined length of between 35 to 45 cm and wherein the overall length of the catheter is between about 145 to 155 cm.

8. A balloon dilatation catheter as defined in claim 7 wherein the combined length of the distal and intermediate segments is about 40 cm.

9. A balloon dilatation catheter as defined in claim 7 further comprising, in combination, a guidewire extending through the guidewire lumen.

10. A balloon dilatation catheter as defined in any of claims 5 or 6 further comprising, in combination, a guidewire extending through the guidewire lumen.

11. A catheter as defined in any of claims 5 or 6 wherein the proximal segment is formed from a metal tube of smaller cross-sectional dimensions than the intermediate plastic segment.

12. A catheter for accessing the coronary arteries in a human, the catheter having a proximal end and a distal end and comprising:

an elongate stiff proximal segment formed of metal;

a relatively flexible elongate plastic member mounted to the distal end of the proximal segment;

the proximal segment being smaller in cross-sectional configuration than the plastic member and being substantially stiffer than the plastic member to provide a sufficient column strength for the proximal segment to resist buckling when advanced through the patient'"'"'s arteries;

the plastic member having a guidewire lumen formed therethrough, the guidewire lumen having a proximal opening in the region of the juncture of the plastic member and the proximal segment and having a distal opening at its distal end whereby when a guidewire is contained within the lumen, the catheter will have continuous column support from its proximal end to its distal tip;

the guidewire lumen extending through the elongate plastic member being open only at said proximal and distal openings, the plastic member completely and continuously circumscribing the guidewire lumen to preclude a guidewire from exiting the guidewire lumen laterally between the proximal and distal openings; and

an instrumentality carried by the distal end of the plastic member adapted to perform a procedure in a coronary artery.

13. A catheter as defined in claim 12 wherein the instrumentality adapted to perform a procedure in an artery comprises a dilatation balloon and where the proximal segment and the plastic member have an inflation lumen fluidly communicating the interior of the balloon with the proximal end of the catheter.

14. A catheter as defined in claim 13 wherein the plastic segment is about 40 cm long.

15. A catheter as defined in claim 13 wherein the guidewire is about 175 cm long.

16. A catheter as defined in claim 12 wherein the plastic segment is between 35 to 45 cm long.

17. A catheter as defined in claim 16 further comprising, in combination, a guidewire in the guidewire lumen.

18. A catheter as defined in any of claims 12, 13 or 14 further comprising, in combination, a guidewire extending through the guidewire lumen.

19. A catheter as defined in any of claims 12-14 wherein the proximal segment comprises a metal shaft having cross-sectional dimensions smaller than those of the elongate plastic member.

20. A catheter as defined in claim 19 wherein said metal shaft comprises a metal tube and wherein said means for performing a procedure comprises a dilatation balloon, the lumen of the metal tube being in fluid communication with the interior of the balloon.

21. A readily exchangeable balloon dilatation catheter comprising:

an elongated, high strength proximal tubular member which is formed of hypotubing, which has proximal and distal ends, and which has an inner lumen extending therein;

a flexible distal tubular member which is secured to the distal end of the high strength proximal tubular member, which has an inflation lumen extending longitudinally therein with a proximal end in fluid communication with the inner lumen of the high strength proximal tubular member and a distal end with an inflation port therein, and which has a guidewire receiving lumen extending longitudinally between a first guidewire port in the proximal end thereof and a distal guidewire port in the distal end thereof, the proximal guidewire port being spaced longitudinally from the distal port in the distal end a distance sufficient to provide guidewire support along the full length of the flexible distal tubular member; and

an inflatable, relatively inelastic balloon on the distal tubular member having a distal end sealingly bonded about the distal end of the distal tubular member and an interior which is in fluid communication with the inflation lumen through the inflation port thereof.

22. A readily exhcangeable balloon dilatation catheter comprising:

an elongated, high strength proximal tubular member which is formed of hypotubing, which has proximal and distal ends, and which has an inner lumen extending therein;

a flexible distal tubular member which is secured to the distal end of the high strength proximal tubular member, which has an inflation lumen extending longitudinally therein with a proximal end in fluid communication with the inner lumen of the high strength proximal tubular member and a distal end with an inflation port therein, and which has a guidewire receiving lumen extending longitudinally between a first guidewire port in the proximal end thereof and a distal guidewire port in the distal end thereof, the proximal guidewire port being spaced longitudinally from the distal port in the distal end a distance sufficient so that it extends over the aortic arch of a patient during a balloon dilatation procedure; and

an inflatable, relatively inelastic balloon on the distal tubular member having a distal end sealingly bonded about the distal end of the distal tubular member and an interior which is in fluid communication with the inflation lumen through the inflation port thereof.

23. A rapidly exchangeable balloon dilatation catheter for accessing the coronary arteries of a human comprising:

an elongate wire-like shaft having proximal and distal ends and a distal region and including a proximal tubular member formed from hypotubing, the shaft having sufficient column strength to enable it to be advanced through a patient'"'"'s vasculature to the coronary arteries, the proximal tubular member having a lumen extending therethrough;

a distal tubular member sufficiently flexible to access the coronary arteries but itself having insufficient column strength for such access without additional support, the distal member being secured to the distal region of and extending distally beyond the distal end of the shaft, the distal member having an inflation lumen extending longitudinally therein and having a proximal end in fluid communication with the lumen of the hypotubing, the inflation lumen being in communication with a balloon inflation port;

the distal tubular member including a longitudinally extending guidewire lumen receptive to a guidewire and having a distal port and a proximal port, the guidewire lumen extending from the distal region of the shaft to the distal end of the distal tubular member and over a distance sufficient, when a guidewire is positioned through the guidewire lumen, to provide the flexible distal tubular member with sufficient column strength to access the coronary arteries, the guidewire and the shaft together supplying support along the full length of the catheter to enable the catheter to be pushed and advanced to a desired location in the coronary arteries; and

an inflatable, relatively inelastic balloon mounted on the distal tubular member having a distal end sealingly attached to the distal end of the distal tubular member and an interior in fluid communication with the inflation lumen through the inflation port.

24. A method for performing a procedure in the coronary arteries in a human comprising:

providing a catheter for accessing the coronary arteries in a human, the catheter having an elongate wire-like shaft having proximal and distal ends and a distal region and including a proximal tubular member formed from hypotubing, the shaft having sufficient column strength to enable it to be advanced through a patient'"'"'s vasculature to the coronary arteries, the proximal tubular member having a lumen extending therethrough, a distal tubular member sufficiently flexible to access the coronary arteries but itself having insufficient column strength for such access without additional support, the distal member being secured to the distal region of and extending distally beyond the distal end of the shaft, the distal member having an inflation lumen extending longitudinally therein and having a proximal end in fluid communication with the lumen of the hypotubing, the inflation lumen being in communication with a balloon inflation port, the distal tubular member including a longitudinally extending guidewire lumen receptive to a guidewire and having a distal port and a proximal port;

percutaneously placing a guidewire in the patient'"'"'s arteries and advancing the guidewire into a selected coronary artery;

percutaneously inserting the catheter into the patient'"'"'s arterial system over the guidewire;

advancing the catheter through the patient'"'"'s arterial system over the guidewire to place the distal end of the catheter in the coronary artery;

whereby the guidewire lumen extends from the distal region of the shaft to the distal end of the distal tubular member and over a distance sufficient, when a guidewire is positioned through the guidewire lumen, to provide the flexible distal tubular member with sufficient column strength to access the coronary arteries, the guidewire and the shaft together supplying support along the full length of the catheter to enable the catheter to be pushed and advanced to a desired location in the coronary arteries.

25. A method for performing a procedure in a coronary artery comprising:

providing a catheter for accessing the coronary arteries in a human, the catheter comprising an elongate stiff proximal segment formed of hypotubing;

a flexible elongate plastic member mounted to the distal end of the proximal segment, the plastic member having a guidewire lumen formed therethrough, the guidewire lumen having a proximal opening in the region of the juncture of the plastic member and the proximal segment and having a distal opening at its distal end whereby when a guidewire is contained within the lumen, the catheter will have a continuous column support from its proximal end to its distal tip;

the proximal segment being of smaller cross-sectional dimensions than the plastic member and being substantially stiffer than the plastic member to provide substantial column strength for the proximal segment to resist buckling when advanced through the patient'"'"'s arteries; and

an instrumentality carried by the distal end of the plastic member adapted to perform a procedure in a coronary artery;

percutaneously placing small steerable guidewire in the patient'"'"'s arteries and advancing the guidewire into a selected coronary artery;

percutaneously inserting a catheter into the patient'"'"'s arterial system over the guidewire;

advancing the catheter through the patient'"'"'s arterial system over the guidewire to place the distal end of the catheter in the coronary artery, with the juncture of the plastic portion and proximal portion of the catheters being disposed proximally of the aortic arch;

whereby the relatively stiff proximal segment of the catheter will remain substantially straight within the descending aorta and the catheter will be supported by the guidewire fully through the aortic arch and into the patient'"'"'s coronary arteries.

26. A method as defined in claim 25 further comprising:

performing a catheter exchange including the steps of withdrawing said catheter while holding the guidewire from its proximal end thereby to maintain the position of the guidewire;

advancing another of said catheters over the guidewire and advancing the catheter along the guidewire to the intended site in the patient'"'"'s coronary arteries.

27. A method as defined in claim 25 wherein the proximal segment of the catheter is formed from metal.

28. A method as defined in claim 25 wherein said instrumentality comprises a dilatation balloon;

means extending through the catheter for inflating and deflating the balloon; and

inflating the balloon within a coronary artery.