Intravascular catheter system for treating a vascular occlusion

• US 6,010,449 A
• Filed: 02/28/1997
• Issued: 01/04/2000
• Est. Priority Date: 02/28/1997
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Milo, Charles, Selmon, Matthew R., Hansen, Gerald
• Primary Examiner(s): Leubecker, John P.
• Application Number:
  US08/808,527
• Time in Patent Office: 1,040 Days
• Field of Search: 600/114, 600/115, 600/116, 600/117, 600/137, 600/146, 606/194, 606/198, 604/96
• US Class Current: 600/117
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An intravascular catheter system for crossing a severe or total arterial occlusion includes a steerable intravascular catheter providing a working element and an optical guidance system. The optical guidance system is realized by an optical member with may include an imaging shaft that is rotated and measured by a motor/encoder assembly or which may include an optical switching device connected to a plurality of optical fibers. The working element may include a plurality of opening members that are actuated by an external plunger.

Claims

1. An intravascular catheter system for treating a vascular occlusion, comprising:

an elongated flexible catheter shaft having a proximal end, a distal end, a plurality of lumina therebetween, a proximal end zone, and a distal end zone;

a steering apparatus for steering the distal end zone of the catheter shaft;

an imaging member within the catheter shaft for acquiring an image of a vessel interior proximate the distal end of the catheter shaft, wherein the imaging member comprises an elongated flexible imaging shaft, rotatably disposed within a lumen of the catheter shaft and being capable of advancement at least to the distal end zone thereof, having a proximal end, a distal end, a proximal end zone, and a distal end zone, wherein the imaging member further comprises a hollow shaft motor and rotational encoder attached to the imaging shaft in the proximal end zone thereof for imparting rotation to and measuring rotation of the flexible imaging shaft; and

a working element disposed in the distal end zone of the catheter shaft for treating the occlusion, wherein the working element is effectively manipulable and directable at a vascular occlusion while the occlusion is imaged.

2. The intravascular catheter system of claim 1, wherein the imaging member further comprises:

at least one distal optical window in the distal end zone of the flexible imaging shaft; and

at least one optical fiber disposed within the imaging shaft, having a proximal end optically connectable to external instruments and a distal end terminating proximate the distal optical window of the imaging shaft, the distal end of the fiber being so disposed within the imaging shaft, and polished at such an angle with respect to the longitudinal axis of the fiber, as to direct an optical beam emitted therefrom through the distal optical window at an angle with respect to the longitudinal axis of the imaging shaft and at an azimuthal angle dependent upon the rotational position of the imaging shaft.

3. The intravascular catheter system of claim 2, wherein the catheter shaft comprises:

an outer surface, at least one lumen terminating in a lateral orifice on an outer surface of the catheter shaft in the distal end zone thereof, at least one balloon disposed on an outer surface of the catheter shaft in the distal end zone thereof and communicating with the lateral orifice for stabilizing the distal end zone of the catheter shaft within an artery; and

at least one lumen, terminating in an orifice on an outer surface of the catheter shaft distal to the balloon, for irrigating the environment of the distal end of the catheter shaft.

4. The intravascular catheter system of claim 2 wherein the working element comprises an occlusion crossing wire having distal end introducible via the proximal end of the intravascular catheter system and capable of projecting distally from the distal end thereof, and a proximal end manipulable from the proximal end zone of the intravascular catheter system.

5. The intravascular catheter system of claim 1, wherein the imaging member further comprises:

at least one distal optical window in an outer surface of the distal end zone of the flexible imaging shaft,

a plurality of optical fibers disposed within the imaging shaft, each fiber having a proximal end optically connectable to external instruments and a distal end disposed in the distal end zone of the imaging shaft, the distal end of each optical fiber being so disposed within the imaging shaft, and polished at such an angle with respect to the fiber, as to direct an optical beam emitted therefrom through the distal optical window at an angle with respect to the longitudinal axis of the imaging shaft; and

an optical multiplexer optically connected to the proximal ends of the optical fibers for selectively optically connecting the proximal ends of the optical fibers to the external instruments.

6. The intravascular catheter system of claim 5 wherein the steering apparatus comprises at least one pulling wire, the wire having a distal end fixed in the distal end zone of the imaging shaft and a proximal end manipulable from the proximal end of the imaging shaft.

7. The intravascular catheter system of claim 6 wherein the working element comprises:

an elongated flexible outer treatment shaft, introducible through a lumen in the catheter shaft from the proximal end zone thereof and capable of advancement to the distal end zone thereof, having a proximal end, a distal end, and at least one lumen therebetween;

an elongated flexible inner treatment shaft disposed within a lumen of the outer treatment shaft and extending substantially the length thereof, having a proximal end, a distal end, and at least one lumen therebetween for allowing the introduction of a guidewire therethrough or the introduction of the treatment shafts over a guidewire;

a plurality of opening members, fixed to the distal ends of the inner and outer treatment shafts, introducible through a lumen in the catheter shaft from the proximal end thereof and slidable and rotatable over a guide wire disposed therein, capable of projecting distally from the distal end of the catheter shaft, closable in a flush position for introduction over a guidewire or through the lumen and openable to urge apart the tissues of an occlusion after being advanced into contact therewith;

an external plunger fixed to the inner treatment shaft near the proximal end thereof; and

an external grip fixed to the outer treatment shaft near the proximal end thereof;

wherein the opening members are moved as the plunger is advanced or retracted with respect to the grip; and

wherein the working element is effectively directable and manipulable at the vascular occlusion while the occlusion is optically imaged.

8. The intravascular catheter system of claim 5 wherein the steering apparatus comprises at least one pulling wire having a distal end disposed in the distal end zone of the catheter shaft and a proximal end manipulable from the proximal end of the catheter shaft, for steering the distal end of the catheter shaft.

9. The intravascular catheter system of claim 8 wherein the working element comprises:

an elongated flexible outer treatment shaft, introducible through a lumen in the catheter shaft from the proximal end zone thereof and capable of advancement to the distal end zone thereof, having a proximal end, a distal end, and at least one lumen therebetween;

an elongated flexible inner treatment shaft disposed within a lumen of the outer treatment shaft and extending substantially the length thereof, having a proximal end, a distal end, and at least one lumen therebetween for allowing the introduction of a guidewire therethrough or the introduction of the treatment shafts over a guidewire;

a plurality of opening members, fixed to the distal ends of the inner and outer treatment shafts, introducible through a lumen in the catheter shaft from the proximal end thereof and slidable and rotatable over a guide wire disposed therein, capable of projecting distally from the distal end of the catheter shaft, closable in a flush position for introduction over a guidewire or through the lumen and openable to urge apart the tissues of an occlusion after being advanced into contact therewith;

an external plunger fixed to the inner treatment shaft near the proximal end thereof; and

an external grip fixed to the outer treatment shaft near the proximal end thereof;

wherein the opening members are moved as the plunger is advanced or retracted with respect to the grip; and

wherein the working element is effectively directable and manipulable at the vascular occlusion while the occlusion is optically imaged.

10. The intravascular catheter system of claim 5 wherein the catheter shaft comprises:

an outer surface, at least one lumen terminating in a lateral orifice on an outer surface of the catheter shaft in the distal end zone thereof, at least one balloon disposed on an outer surface of the catheter shaft in the distal end zone thereof and communicating with the lateral orifice for stabilizing the distal end zone of the catheter shaft within an artery; and

at least one lumen, terminating in an orifice on an outer surface of the catheter shaft distal to the balloon, for irrigating the environment of the distal end of the catheter shaft.

11. The intravascular catheter system of claim 5 wherein the working element comprises an occlusion crossing wire having distal end introducible via the proximal end of the intravascular catheter system and capable of projecting distally from the distal end thereof, and a proximal end manipulable from the proximal end zone of the intravascular catheter system.

12. The intravascular catheter system of claim 1, wherein the imaging member comprises:

a plurality of optical fibers disposed within the catheter shaft, each fiber having a proximal end optically connectable to external instruments and a distal end disposed in the distal end zone of the catheter shaft, the catheter shaft having at least one distal optical window in an outer surface of the distal end zone thereof, the distal end of each optical fiber being so disposed within the catheter shaft, and polished at such an angle, as to direct an optical beam emitted therefrom through the distal optical window at an angle with respect to the longitudinal axis of the catheter shaft, and at an azimuthal angle unique to each fiber; and

an optical multiplexer optically connected to the proximal ends of the optical fibers for selectively optically connecting the proximal ends of the optical fibers to external instruments.

13. The intravascular catheter system of claim 12 wherein the steering apparatus comprises at least one elongated flexible steering shaft, disposed in a lumen of the catheter shaft, having a proximal end, having a distal end having a distal end zone capable of advancement to the distal end zone of the catheter shaft, and having at least one pulling wire, the wire having a distal end fixed in the distal end zone of the steering shaft and a proximal end manipulable from the proximal end of the steering shaft.

14. The intravascular catheter system of claim 13 wherein the working element comprises:

an elongated flexible outer treatment shaft, introducible through a lumen in the catheter shaft from the proximal end zone thereof and capable of advancement to the distal end zone thereof, having a proximal end, a distal end, and at least one lumen therebetween;

an elongated flexible inner treatment shaft disposed within a lumen of the outer treatment shaft and extending substantially the length thereof, having a proximal end, a distal end, and at least one lumen therebetween for allowing the introduction of a guidewire therethrough or the introduction of the treatment shafts over a guidewire;

a plurality of opening members, fixed to the distal ends of the inner and outer treatment shafts, introducible through a lumen in the catheter shaft from the proximal end thereof and slidable and rotatable over a guide wire disposed therein, capable of projecting distally from the distal end of the catheter shaft, closable in a flush position for introduction over a guidewire or through the lumen and openable to urge apart the tissues of an occlusion after being advanced into contact therewith;

an external plunger fixed to the inner treatment shaft near the proximal end thereof; and

an external grip fixed to the outer treatment shaft near the proximal end thereof;

wherein the opening members are moved as the plunger is advanced or retracted with respect to the grip; and

wherein the working element is effectively directable and manipulable at the vascular occlusion while the occlusion is optically imaged.

15. The intravascular catheter system of claim 12 wherein the steering apparatus comprises at least one pulling wire having a distal end disposed in the distal end zone of the catheter shaft and a proximal end manipulable from the proximal end of the catheter shaft, for steering the distal end of the catheter shaft.

16. The intravascular catheter system of claim 15 wherein the working element comprises:

an elongated flexible outer treatment shaft, introducible through a lumen in the catheter shaft from the proximal end zone thereof and capable of advancement to the distal end zone thereof, having a proximal end, a distal end, and at least one lumen therebetween;

an elongated flexible inner treatment shaft disposed within a lumen of the outer treatment shaft and extending substantially the length thereof, having a proximal end, a distal end, and at least one lumen therebetween for allowing the introduction of a guidewire therethrough or the introduction of the treatment shafts over a guidewire;

a plurality of opening members, fixed to the distal ends of the inner and outer treatment shafts, introducible through a lumen in the catheter shaft from the proximal end thereof and slidable and rotatable over a guide wire disposed therein, capable of projecting distally from the distal end of the catheter shaft, closable in a flush position for introduction over a guidewire or through the lumen and openable to urge apart the tissues of an occlusion after being advanced into contact therewith;

an external plunger fixed to the inner treatment shaft near the proximal end thereof; and

an external grip fixed to the outer treatment shaft near the proximal end thereof;

wherein the opening members are moved as the plunger is advanced or retracted with respect to the grip; and

wherein the working element is effectively directable and manipulable at the vascular occlusion while the occlusion is optically imaged.

17. The intravascular catheter system of claim 12 wherein the catheter shaft comprises:

an outer surface, at least one lumen terminating in a lateral orifice on an outer surface of the catheter shaft in the distal end zone thereof, at least one balloon disposed on an outer surface of the catheter shaft in the distal end zone thereof and communicating with the lateral orifice for stabilizing the distal end zone of the catheter shaft within an artery; and

at least one lumen, terminating in an orifice on an outer surface of the catheter shaft distal to the balloon, for irrigating the environment of the distal end of the catheter shaft.

18. The intravascular catheter system of claim 12 wherein the working element comprises an occlusion crossing wire having distal end introducible via the proximal end of the intravascular catheter system and capable of projecting distally from the distal end thereof, and a proximal end manipulable from the proximal end zone of the intravascular catheter system.

19. The intravascular catheter system for treating a vascular occlusion comprising:

an elongated flexible catheter shaft having a proximal end, a distal end, a plurality of lumina therebetween, a proximal end zone, and a distal end zone;

a steering apparatus for steering the distal end zone of the catheter shaft;

an imaging member within the catheter shaft for acquiring an image of a vessel interior proximate the distal end of the catheter shaft; and

a working element disposed in the distal end zone of the catheter shaft for treating the occlusion;

whereby the working element is effectively manipulable and directable at a vascular occlusion while the occlusion is optically imaged, and wherein the working element comprises a plurality of opening members, each of which being projectable distally from the distal end of the catheter shaft and openable to urge apart tissues of an occlusion after being advanced into contact therewith, and wherein the working element comprises;

an elongated flexible outer treatment shaft, introducible through a lumen in the catheter shaft from the proximal end zone thereof and capable of advancement to the distal end zone thereof, having a proximal end, a distal end, and at least one lumen therebetween;

an elongated flexible inner treatment shaft disposed within a lumen of the outer treatment shaft and extending substantially the length thereof, having a proximal end, a distal end, and at least one lumen therebetween for allowing the introduction of a guidewire therethrough or the introduction of the treatment shafts over a guidewire;

a plurality of opening members, fixed to the distal ends of the inner and outer treatment shafts, introducible through a lumen in the catheter shaft from the proximal end thereof and slidable and rotatable over a guide wire disposed therein, capable of projecting distally from the distal end of the catheter shaft, closable in a flush position for introduction over a guidewire or through the lumen and openable to urge apart tissues of an occlusion after being advanced into contact therewith;

an external plunger fixed to the inner treatment shaft near the proximal end thereof; and

an external grip fixed to the outer treatment shaft near the proximal end thereof;

whereby the opening members are moved as the plunger is advanced or retracted with respect to the grip; and

whereby the working element is effectively directable and manipulable at the vascular occlusion while the occlusion is optically imaged.

20. The intravascular catheter system of claim 19 wherein the catheter shaft comprises:

an outer surface, at least one lumen terminating in a lateral orifice on an outer surface of the catheter shaft in the distal end zone thereof, at least one balloon disposed on an outer surface of the catheter shaft in the distal end zone thereof and communicating with the lateral orifice for stabilizing the distal end zone of the catheter shaft within an artery; and

at least one lumen, terminating in an orifice on an outer surface of the catheter shaft distal to the balloon, for irrigating the environment of the distal end of the catheter shaft.

21. An intravascular catheter system for treating a vascular occlusion, comprising:

an elongated flexible catheter shaft having a proximal end, a distal end, a plurality of lumina therebetween, a proximal end zone, and a distal end zone;

a steering apparatus for steering the distal end zone of the catheter shaft;

an imaging member within the catheter shaft for acquiring an image of a vessel interior proximate the distal end of the catheter shaft; and

a working element disposed in the distal end zone of the catheter shaft for treating the occlusion;

whereby the working element is effectively manipulable and directable at a vascular occlusion while the occlusion is optically imaged, and wherein the catheter shaft comprises;

first, second, and third lumina between the proximal and distal ends of the catheter shaft;

a steering apparatus disposed in the first lumen for steering the distal end zone of the catheter shaft;

an imaging member disposed in the second lumen for acquiring an image of the vessel interior proximate the distal end of the catheter shaft; and

a working element disposed in the third lumen for treating the occlusion;

whereby the working element is effectively manipulable and directable at the vascular occlusion while the occlusion is optically imaged, and wherein the working element comprises;

an elongated flexible outer treatment shaft, introducible through a lumen in the catheter shaft from the proximal end zone thereof and capable of advancement to the distal end zone thereof, having a proximal end, a distal end, and at least one lumen therebetween;

an elongated flexible inner treatment shaft disposed within a lumen of the outer treatment shaft and extending substantially the length thereof, having a proximal end, a distal end, and at least one lumen therebetween for allowing the introduction of a guidewire therethrough or the introduction of the treatment shafts over a guidewire;

a plurality of opening members, fixed to the distal ends of the inner and outer treatment shafts, introducible through a lumen in the catheter shaft from the proximal end thereof and slidable and rotatable over a guide wire disposed therein, capable of projecting distally from the distal end of the catheter shaft, closable in a flush position for introduction over a guidewire or through the lumen and openable to urge apart the tissues of an occlusion after being advanced into contact therewith;

an external plunger fixed to the inner treatment shaft near the proximal end thereof; and

an external grip fixed to the outer treatment shaft near the proximal end thereof;

whereby the opening members are moved as the plunger is advanced or retracted with respect to the grip; and

whereby the working element is effectively directable and manipulable at the vascular occlusion while the occlusion is optically imaged.

22. The intravascular catheter system of claim 21 wherein the catheter shaft comprises an outer surface, at least one lumen terminating in a lateral orifice on an outer surface of the catheter shaft in the distal end zone thereof, and at least one balloon, disposed on an outer surface of the catheter shaft in the distal end zone thereof and communicating with the lateral orifice, for stabilizing the distal end zone of the catheter shaft within a vessel.

23. The intravascular catheter system of claim 21 wherein the catheter shaft comprises at least one lumen, terminating in an orifice on an outer surface of the distal end of the catheter shaft, for irrigating the environment of the distal end of the catheter shaft.

24. The intravascular catheter system of claim 22 wherein the catheter shaft comprises at least one lumen, terminating in an orifice on an outer surface of the catheter shaft distal to the balloon, for irrigating the environment of the distal end of the catheter shaft.