Intravascular device for coronary heart treatment

• US 5,527,292 A
• Filed: 09/09/1994
• Issued: 06/18/1996
• Est. Priority Date: 10/29/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Daniel O., Thome, Scott P.
• Primary Examiner(s): Maglione, Corrine M.
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/303,590
• Time in Patent Office: 648 Days
• Field of Search: 604/162, 604/163, 604/160, 604/158, 604/159, 604/161, 604/166, 604/282, 604/283, 604/93, 604/96, 604/100, 604/164, 604/171, 604/264, 604/280, 604/281, 604/284, 128/657, 128/658, 128/772, 606/108, 606/119, 606/121
• US Class Current: 604/171
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0172 Exchanging a guidewire while keeping the catheter in place
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intravascular device having an elongated flexible tube sized for insertion into a coronary vessel beyond a distal end of a guide catheter. In use, the flexible tube has its proximal end within a guide catheter and has its distal end extending to a treatment site in a coronary artery. The device also including a push rod attached to a proximal end of the flexible tube to facilitate placement of the flexible tube within the coronary artery requiring treatment. In certain applications, the intravascular device is used as a drug (or other fluid) delivery device or as an aspiration device. In other applications, the intravascular device is used as a guiding means for placement of an angioplasty device, such as a guide wire or a balloon catheter. Additionally, an attachment tube may be provided which is designed to couple with a proximal end of the flexible tube to provide a continuous conduit for aspiration or fluid delivery to a treatment site in a coronary artery.

Claims

1. A guide catheter system comprising:

a guide catheter;

a relatively flexible tube having an outer diameter sized for insertion into a coronary vessel and an inner diameter defining a lumen therethrough, the tube having a proximal end and a distal end, the extent therebetween defining an extension length of the flexible tube, the length of the tube being sized so that the proximal end of the tube is enclosed within the guide catheter and the distal end extends into the vessel to reach a treatment site, the tube being movable between a first retracted position and a second extended position;

a push rod having a proximal end and a distal end, the distal end of the push rod being coupled to the proximal end of the tube for slidably positioning the tube in the vessel; and

a fluid seal positioned at the proximal end of the tube and coupled between the tube and the guide catheter for fluidly sealing between the tube and the guide catheter when the tube is in the second extended position.

2. The guide catheter system of claim 1 wherein the relatively flexible tube of the intravascular device includes a coil spring extending along and defining at least a portion of the flexible tube.

3. The guide catheter system of claim 2 further including an inner layer and an outer layer of a polymer material surrounding the coil spring.

4. The guide catheter system of claim 1 wherein the inner diameter of the tube is sized to permit placement of a guide wire through the tube.

5. The guide catheter system of claim 1 wherein the inner diameter of the tube is sized to permit placement of an angioplasty balloon catheter through the tube.

6. The guide catheter system of claim 1 wherein the flexible tube of the intravascular device is 6 to 12 inches in length.

7. The guide catheter system of claim 1 wherein the push rod is a wire.

8. The guide catheter system of claim 1 wherein the push rod has a length of 40 to 45 inches.

9. The intravascular device of claim 1 wherein the push rod includes a visual marker on a proximal end thereof.

10. An improved intravascular device for use in combination with a guide catheter having a distal end, a proximal end and an internal diameter defining a central lumen, the improvement comprising:

a relatively flexible tube having an outer diameter sized for insertion through the central lumen of the guide catheter into a coronary vessel, the flexible tube being concentrically aligned with the guide catheter and the tube having an inner diameter defining an internal lumen therethrough, the tube having a proximal end and a distal end, the extent therebetween defining an extension length of the flexible tube, the length of the tube being sized so that the proximal end of the tube terminates adjacent the distal end of the the guide catheter and the distal end extends into the vessel to reach a treatment site;

a proximal funnel formed near the proximal end of the flexible tube, the proximal funnel having a distally tapered frusto-conical portion, the distally tapered frusto-conical portion defining an opening between the central lumen of the guide catheter and the internal lumen of the tube for allowing fluid communication therebetween, the distally tapered frusto-conical portion including a first proximal outer diameter and a second smaller distal outer diameter, the first outer diameter coinciding with the internal diameter of the guide catheter to provide a tight interaction therebetween; and

a push rod coupled to the proximal end of the tube for slidably positioning the tube for placement.

11. A guide wire placement system for placement of a guide wire into a coronary vessel of a patient, the guide wire placement system comprising:

a guide catheter having a proximal end, a distal end, and a central lumen extending therethrough;

a relatively flexible tube sized for insertion into a coronary vessel through the central lumen of the guide catheter into a coronary vessel, the flexible tube of the intravascular device being concentrically aligned with the guide catheter and having a proximal end and a distal end, the extent therebetween defining an extension length of the flexible tube, the length of the tube being sized so that the proximal end of the tube terminates adjacent the distal end of the guide catheter and the distal end extends into the vessel to reach a treatment site, the tube defining an internal lumen being sized to receive the guide wire therethrough for placement of the guide wire into the patient, the tube having sufficient rigidity to support a pre-formed guide wire for advancement and placement into the vessel;

a push rod attached to the proximal end of the tube for slidably positioning the tube for placement with the guide wire, wherein the tube is slidable between a first retracted position and a second extended position; and

means for coupling the proximal end of the flexible tube adjacent to the distal end of the guide catheter when the tube is positioned in the second extended position, the means having an opening between the central lumen of the guide catheter and the internal lumen of the tube allowing fluid communication therebetween to form a continuous lumen from the proximal end of the guide catheter into the treatment site.

12. For use in combination with a guide catheter having an inner diameter defining a central lumen, a proximal end and a distal end, an improvement comprising:

a distal extension device including;

a relatively flexible tube defining an inner lumen and being sized for insertion through the central lumen of the guide catheter into a coronary vessel requiring treatment, the flexible tube being concentrically aligned with he guide catheter, the tube having a proximal end and a distal end, the extent therebetween defining an extension length of the flexible tube, the length of the tube being sized so that the proximal end of the tube terminates adjacent the distal end of the guide catheter and the distal end of the flexible tube extends into a vessel to reach a treatment site;

means extending between the proximal end of the tube and the inner diameter of the guide catheter for joining the central lumen and the inner lumen in fluid communication with one another to establish a continuous lumen beyond the distal end of the guide catheter into a coronary vessel; and

a push rod coupled to the proximal end of the flexible tube for placement of the tube into the vessel requiring treatment.

13. The distal extension device of claim 12 wherein the means for joining includes a proximal funnel formed at the proximal end of the flexible tube, the proximal funnel having a distally tapered frusto-conical portion, the distally tapered frusto-conical portion having an opening between the central lumen and the inner lumen to allow fluid communication therebetween and including a first outer diameter and a second smaller outer diameter, the first outer diameter coinciding with an internal diameter of a guide catheter to provide a tight interaction therebetween for sealing the guide catheter relative to the flexible tube of the drug delivery device.

14. The distal extension device of claim 13 wherein the distally tapered frusto-conical portion of the proximal funnel includes a recessed channel through which the push rod extends for attachment thereof to the flexible tube of the distal extension device.

15. The distal extension device of claim 14 wherein the proximal funnel includes an elongated tubular portion extending from the frusto-conical portion, the elongated tubular portion of the proximal funnel surrounding the flexible tube.

16. The distal extension device of claim 15 wherein a bond sleeve encloses the push rod and the elongated tubular portion of the proximal funnel to provide a smooth transitional surface.

17. The distal extension device of claim 12 wherein the flexible tube includes a coil spring extending along and defining at least a portion of the flexible tube.

18. The distal extension device of claim 17 further including an inner layer and an outer layer of polymer material about the coil spring.

19. The distal extension device of claim 12 wherein the push rod is a wire.

20. The distal extension device of claim 19 wherein the wire has a flattened distal end to provide an attachment surface for connection to the flexible tube.

21. A fluid delivery system for delivering fluid into and through a coronary vessel to a treatment site, the system comprising:

a guide catheter having a proximal end and a distal end;

a relatively flexible tube sized for insertion through the coronary vessel, the tube defining an inner lumen for fluid delivery, the length of the tube being sized so that the proximal end of the tube aligns with the distal end of the guide catheter and the distal end of the tube extends into the vessel to reach the treatment site;

a push rod coupled to the flexible tube and extending proximally therefrom for placement of the tube into the vessel, wherein the flexible tube is movable between a first retracted position and a second extended position; and

means adjacent a distal portion of the guide catheter for fluidly sealing between the tube and the guide catheter when the tube is extended into the second extended position.

22. For use in combination with a guide catheter for insertion and advancement of a coronary treatment device through a coronary vessel having an ostium to a treatment site, the guide catheter having a central lumen, a distal end and a distal opening, an anchoring device comprising:

a relatively flexible tube sized for insertion through the central lumen of the guide catheter into the coronary vessel, the flexible tube being concentrically aligned with the guide catheter, the tube having a proximal end and a distal end, the extent therebetween defining an extension length of the flexible tube, the length of the tube being sized so that the proximal end of the tube aligns with the distal end of the guide catheter and the distal end of the tube extends into the vessel to reach the treatment site; and

a push rod eccentrically coupled to the tube and extending proximally therefrom for placement of the tube, wherein the flexible tube anchors the distal opening of the guide catheter relative to the ostium of the coronary vessel to secure the guide catheter and facilitate insertion of the coronary treatment device therethrough.

23. An aspiration system for withdrawing blood clotting material from a treatment site within a coronary vessel, the aspiration system comprising:

a guide catheter having a proximal end, a distal end, a central lumen, and an internal diameter;

a relatively flexible tube sized for insertion through the central lumen of the guide catheter into a coronary vessel requiring treatment, the flexible tube being concentrically aligned with the guide catheter, the tube having a proximal end and a distal end, the extent therebetween defining an extension length of the flexible tube, wherein the flexible tube is movable between a first retracted position and a second extended position, the length of the tube being sized so that the proximal end of the tube aligns with the distal end of the guide catheter and the distal end of the tube extends into a vessel to reach the treatment site when the flexible robe is in the second extended position;

a push rod coupled to the proximal end of the tube for slidably positioning the tube for placement, wherein the flexible tube is movable between a first retracted position and a second extended position; and

a seal at the proximal end of the tube and coupled between the tube and the guide catheter for sealing between the tube and the guide catheter when the distal end of the tube is extended into the second extended position.

24. The aspiration system of claim 23 wherein the proximal end of the tube terminates within the guide catheter and wherein the seal comprises:

a proximal funnel formed at the proximal end of the flexible tube, the proximal funnel having a distally tapered frusto-conical portion, the distally tapered frusto-conical portion having an opening between the central lumen of the outer tube and the internal lumen of the inner tube to allow fluid communication therebetween, the distally tapered frusto-conical portion defining a first proximal outer diameter and a second smaller distal outer diameter, the first outer diameter coinciding with the internal diameter of the guide catheter to provide a tight interaction therebetween for sealing the guide catheter relative to the flexible tube for aspiration treatment.

25. For use in combination with a guide catheter having a proximal end, a distal end, and a central lumen, an intravascular device comprising:

a relatively flexible tube having a proximal end, a distal end, an outer diameter and an internal lumen, wherein the outer diameter is sized for insertion through the central lumen of the guide catheter so that the distal end of the tube may be positioned beyond the distal end of the guide catheter to extend the flexible tube to a treatment site; and

a push rod eccentrically coupled to the tube and extending proximally therefrom for slidably positioning the tube.

26. An intravascular system comprising:

a guide catheter having a proximal end, a distal end, a central lumen, and an internal diameter;

a relatively flexible tube having a proximal end, a distal end, an outer diameter and an internal lumen, wherein the outer diameter is sized for insertion through the central lumen of the guide catheter so that the distal end of the tube may be positioned beyond the distal end of the guide catheter to extend the flexible tube to the treatment site and wherein the proximal end of the tube terminates adjacent the distal end of the the guide catheter;

means for coupling the proximal end of the flexible tube relative to the distal end of the guide catheter, the means having an opening between the central lumen of the guide catheter and the internal lumen of the tube allowing fluid communication therebetween to form a continuous lumen from the proximal end of the guide catheter into a coronary vessel to the treatment site; and

a push rod eccentrically coupled to the proximal end of the tube for slidably positioning the tube.

27. The system of claim 26 wherein the means for coupling includes a proximal funnel formed at the proximal end of the flexible tube, the proximal funnel having a distally tapered frusto-conical portion, the distally tapered frusto-conical portion having an opening between the central lumen of the outer tube and the internal lumen of the inner tube to allow fluid communication therebetween, the distally tapered frusto-conical portion defining a first proximal outer diameter and a second smaller distal outer diameter, the first outer diameter coinciding with the internal diameter of the guide catheter to provide a tight interaction therebetween.

28. The system of claim 27 wherein the proximal funnel includes an elongated tubular portion extending from the frusto-conical portion, the elongated tubular portion of the proximal funnel surrounding the flexible tube.

29. The system of claim 28 wherein a bond sleeve encloses the push rod and the elongated tubular portion of the proximal funnel to provide a smooth transitional surface.

30. The system of claim 27 wherein the distally tapered frusto-conical portion of the proximal funnel includes a recessed channel through which the push rod extends for attachment thereof to the flexible tube of the device.

31. The system of claim 26 wherein the flexible tube includes a coil spring extending along and defining at least a portion of the flexible tube.

32. The system of claim 31 wherein an inner layer and an outer layer of polymeric material surround the coil spring.

33. The system of claim 26 wherein the push rod is a wire.

34. An intravascular system comprising;

a first main outer tube having a proximal end, a distal end, an inner diameter, an outer diameter, and a central lumen;

a second inner tube having a proximal end and a distal end, wherein the second inner tube is adapted to be positioned within and through the first main outer tube, the second inner tube including an internal lumen having a distal opening, wherein the internal lumen is in fluid communication with the central lumen of the guide catheter and wherein the second inner tube is flexible so that the inner tube may be directed through a coronary ostium to position the distal opening at a treatment site; and

a push rod coupled to the second inner tube for slidably positioning the second inner tube relative to the first main outer tube.

35. The system of claim 34 wherein the proximal end of the second inner tube terminates adjacent the distal end of the main outer tube, the system further including means for coupling the proximal end of the second inner tube to the distal end of the main outer tube, the means having an opening between the central lumen of the guide catheter and the internal lumen of the tube allowing fluid communication therebetween to form a continuous lumen beyond the distal end of the main outer tube into the ostium of the coronary vessel.

36. The system of claim 35 wherein the means for coupling includes a proximal funnel formed at the proximal end of the inner tube, the proximal funnel having a distally tapered frusto-conical portion, the distally tapered frusto-conical portion having an opening between the central lumen of the outer tube and the internal lumen of the inner tube to allow fluid communication therebetween, the distally tapered frusto-conical portion defining a first outer diameter and a second smaller outer diameter, the first outer diameter coinciding with the internal diameter of the first main outer tube to provide tight interaction therebetween for sealing the main outer tube relative to the inner tube.

37. The system of claim 34 wherein the second inner tube includes a coil spring extending along and defining at least a portion of the inner tube.

38. The system of claim 37 further including a layer of polymeric material surrounding the coil spring.

39. The system of claim 34 wherein the push rod is coupled to a proximal end of the inner tube.

40. The system of claim 34 wherein the push rod is eccentrically coupled to the second inner tube so that the internal lumen of the second inner tube remains substantially unobstructed.

41. The system of claim 34 wherein the push rod is a wire.