Methods and apparatus for treating vascular occlusions

• US 6,746,462 B1
• Filed: 03/28/2000
• Issued: 06/08/2004
• 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: Pai, Suresh S., Dell, Kent D., Gresl, Charles, Milo, Charles F., Selmon, Matthew R., Wynne, Robert L.
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): DAVIS, DANIEL J
• Application Number:
  US09/538,850
• Time in Patent Office: 1,533 Days
• Field of Search: 606/191, 606/192, 606/190, 606/159, 606/195, 606/194, 606/198, 600/206, 600/207
• US Class Current: 606/159
• 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 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2933 camming or guiding means
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An intravascular catheter system for the treatment of occluded blood vessels that includes tissue displacement or hinged expansion members that are movable from a closed to an open position. An actuating assembly may be provided for moving the tissue expansion members between an open and closed position to exert a substantially lateral distal end force upon the region surrounding an occluded blood vessel. The tissue expansion members may stretch apart, tear or otherwise disrupt a vascular occlusion sufficiently to create a pathway that may support the passage or placement of a guidewire or an interventional vascular device across the occlusion or obstruction. Methods of crossing or displacing a vascular occlusion are further provided that include the positioning of a vascular catheter having at least one hinged spreading member positioned at the distal region of the catheter that is responsive to directed force along the longitudinal axis of the catheter. A directed force is applied to the actuator in order to deploy the spreading member and displace a vascular occlusion creating a path to permit the passage of a guidewire or device therethrough.

Claims

1. A method of crossing a substantially occluded blood vessel, comprising:

positioning an intravascular catheter in a blood vessel, the intravascular catheter comprising a distally mounted assembly that includes a tissue expanding member pivotally coupled to a relatively fixed lower extension, the tissue expanding member defined by a distal end that is configured to expand relative to a proximal end;

advancing the assembly within the blood vessel to a point proximate to an occlusion;

activating the tissue expanding member by rotating the distal end of the tissue expanding member away from the fixed lower extension to apply a fracturing force to tissue of the blood vessel and the occlusion;

disrupting material of the occlusion and generating a path through the material of the occlusion in response to the application of the fracturing force; and

advancing the intravascular catheter into tissue of the occlusion using the path so that the intravascular catheter crosses through the material of the occlusion and all material of the occlusion remains external to the intravascular catheter.

2. The method of claim 1, further comprising selecting a guidewire and passing the guidewire through at least a portion of the occlusion before removing the tissue expanding member.

3. A method of crossing an occlusion, comprising:

advancing a first guidewire within a blood vessel of vasculature to the occlusion;

advancing an intra-coronary guiding catheter over the first guidewire so that a distal end of the guiding catheter is in proximity to the occlusion;

removing the first guidewire from the blood vessel;

advancing an intravascular catheter through the intra-coronary guiding catheter to position at least one spreading member of a distal end of the intravascular catheter adjacent to the occlusion;

applying a fracturing force to tissue of the blood vessel and the occlusion by moving a distal end of the at least one spreading member laterally away from a longitudinal center line of the vascular catheter by deflecting the at least one spreading member around a proximal end of the at least one spreading member in response to a spreading force;

disrupting material of the occlusion and generating a path through the material of the occlusion in response to the application of the fracturing force; and

advancing the intravascular catheter through a portion of the tissue of the occlusion using the path so that the intravascular catheter crosses through the material of the occlusion and all material of the occlusion remains external to the intravascular catheter.

4. The method of claim 3, further comprising advancing the intra-coronary guiding catheter past the occlusion before removing the intravascular catheter from the blood vessel.

5. The method of claim 3, further comprising advancing a second guidewire past the displaced occlusion after removing the intravascular catheter and before removing the intra-coronary guiding catheter.

6. The method of claim 3, further comprising selecting and advancing a second guide wire across the vascular occlusion within the blood vessel.

7. The method of claim 3, further comprising advancing the intra-coronary guiding catheter past the occlusion before removing the intravascular catheter and before advancing a second guidewire through the intra-coronary guiding catheter.

8. The method of claim 4, further comprising advancing a second guidewire across the occlusion using the guiding catheter after advancing the guiding catheter past the occlusion.

9. A method of displacing tissue of an occlusion, comprising:

providing an intravascular catheter having a proximal section, a distal section, a longitudinal axis, at least one lumen extending therein, and a tissue displacing assembly positioned at the distal section of the catheter that has at least one tissue displacing member which is configured to rotate about one end thereof and which is responsive to directed force along the longitudinal axis of the catheter and an actuator assembly positioned at least in part within the catheter to transmit a directed force applied from the proximal section of the catheter to the tissue displacing member;

positioning the tissue displacing member on the distal section of the intravascular catheter at least partly within the occlusion;

applying a directed force to the actuator assembly to rotate the tissue displacing member within or adjacent to the occlusion;

displacing tissue of the occlusion and generating a path through the tissue of the occlusion in response to the application of the directed force; and

advancing the intravascular catheter through a portion of the tissue of the occlusion using the path so that the intravascular catheter crosses through the tissue of the occlusion and all tissue of the occlusion remains external to the intravascular catheter.

10. A method of crossing a substantially occluded blood vessel, comprising:

providing an intravascular catheter having proximal and distal extremities, a tissue expanding member mounted on the distal extremity and a distal portion configured to expand relative to the proximal portion of the expanding member and an actuation assembly to transmit a spreading force to the tissue expanding member to expand the distal portion thereof;

advancing the catheter within a patient'"'"'s vasculature until the tissue expanding member is disposed within or adjacent to an occlusion within a blood vessel; and

activating the actuation assembly to expand the distal portion of the tissue expanding member;

displacing material of the occlusion and generating a path through the material of the occlusion in response to activation of the actuation assembly; and

advancing the intravascular catheter through tissue of the occlusion using the path so that the intravascular catheter crosses through the material of the occlusion and all material of the occlusion remains external to the intravascular catheter.

11. The method of claim 10, wherein the distal portion of the tissue expanding member has an expanded and unexpanded configuration and wherein the expanded configuration has a maximum dimension at least one-and-a-half times a maximum dimension of the unexpanded configuration.

12. A method of crossing a coronary vascular occlusion, comprising:

advancing a guidewire within a blood vessel to a vascular occlusion;

advancing a guiding catheter having a distal end over the guidewire until the distal end of the guiding catheter is in proximity to the vascular occlusion;

at least partially withdrawing the guidewire from the blood vessel;

providing an intravascular catheter having a proximal portion and a distal portion, a longitudinal axis, at least one lumen extending therein, a spreading member positioned at the distal portion of the intravascular catheter that is responsive to directed force along the longitudinal axis of the intravascular catheter and an actuator assembly to transmit a directed force applied from the proximal portion of the catheter to the spreading member;

advancing the intravascular catheter trough the intra-coronary guiding catheter to position the spreading member of the intravascular catheter substantially within or adjacent to the vascular occlusion within the blood vessel;

applying a directed force to the actuator assembly to spread apart the spreading member;

displacing tissue of the occlusion and generating a path through the tissue of the occlusion in response to the application of the directed force; and

advancing the intravascular catheter through a portion of the tissue of the occlusion via the path so that the intravascular catheter crosses through the material of the occlusion and all material of the occlusion remains external to the intravascular catheter.

13. A method for transcending a vascular occlusion, comprising:

positioning a vascular catheter adjacent to a vascular occlusion within vasculature;

transmitting a spreading force to a proximal region of at least one spreading member located at a distal end of the vascular catheter;

moving a distal end of the at least one spreading member laterally away from a longitudinal center line of the vascular catheter by deflecting the at least one spreading member around a proximal end of the at least one spreading member in response to the spreading force;

displacing tissue of the occlusion and generating at least one path through the tissue of the occlusion in response to the application of the spreading force;

advancing the vascular catheter along the at least one path and through the tissue of the occlusion via the path so that the vascular catheter crosses through the tissue of the occlusion and all tissue of the occlusion remains external to the vascular catheter; and

advancing a guide wire through at least one conduit of the vascular catheter and along the at least one path.

14. The method of claim 13, wherein forming at least one path comprises disrupting the vascular occlusion creating a path substantially through the occlusion.

15. The method of claim 13, wherein forming at least one path comprises stretching out a vessel wall of the vasculature creating a path substantially between the occlusion and the vessel wall.

16. The method of claim 15, wherein forming the at least one path comprises separating layers of the vessel wall creating a path substantially between the layers of the vessel wall.

17. The method of claim 13, further comprising:

removing the vascular catheter;

positioning at least one interventional device substantially adjacent the vascular occlusion, wherein the at least one interventional device comprises at least one device selected from a group consisting of an angioplasty device, an atherectomy device, a stent, a guidewire, an imaging catheter, a drug delivery device, and a radiation catheter.

18. The method of claim 13, further comprising:

maintaining the vascular catheter in at least one position along the at least one path;

placing the guide wire across the occlusion.

19. The method of claim 13, wherein the guidewire is advanced through at least a portion of the occlusion.

20. The method of claim 13, wherein the guidewire is advanced around at least a portion of the occlusion.

21. The method of claim 13, wherein the guidewire is advanced between layers of a vessel wall of the vasculature.

22. The method of claim 13, wherein the vascular catheter is advanced through at least a portion of the occlusion.

23. The method of claim 13, wherein activation of the at least one spreading member provides intermittent expansion.