Methods and apparatus for treating vascular occlusions

• US 6,217,549 B1
• Filed: 09/08/1998
• Issued: 04/17/2001
• 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): Coggins, Wynn Wood
• Assistant Examiner(s): KLINE, ERIC E
• Application Number:
  US09/149,875
• Time in Patent Office: 952 Days
• Field of Search: 604/507-510, 604/104-107, 606/159, 606/170
• US Class Current: 604/106
• 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 for transcending a vascular occlusion, comprising:

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

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

rotating a distal end of the at least one spreading member around a proximal end of the at least one spreading member in response to the spreading force;

forming at least one path that transcends the vascular occlusion;

advancing the vascular catheter along the at least one path; and

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

2. The method as recited in claim 1, further comprising:

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

placing the guide wire across the occlusion.

3. The method as recited in claim 1, wherein the guidewire is advanced through at least a portion of the occlusion.

4. The method as recited in claim 1, wherein the guidewire is advanced around at least a portion of the occlusion.

5. The method as recited in claim 1, wherein the guidewire is advanced between layers of a blood vessel wall.

6. The method as recited in claim 1, wherein forming at least one path comprises stretching out a blood vessel wall of the peripheral vasculature creating a path substantially between the occlusion and the blood vessel wall.

7. The method as recited in claim 3, wherein forming at least one path comprises separating layers of the blood vessel wall creating a path substantially between the layers of the blood vessel wall.

8. The method as recited in claim 1, wherein forming at least one path comprises disrupting the vascular occlusion creating a path substantially through the occlusion.

9. The method as recited in claim 1, 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.

10. The method as recited in claim 1, wherein a distal portion of the at least one spreading member is defined by an original diameter and wherein the distal portion expands to an enlarged diameter that is equal to at least approximately one-hundred and ten percent of the original diameter.

11. The method as recited in claim 1, wherein the vascular catheter is advanced through at least a portion of the occlusion.

12. The method as recited in claim 1, wherein activation of the at least one spreading member provides intermittent expansion.