Methods and apparatus for treating vascular occlusions

• US 6,800,085 B2
• Filed: 04/13/2001
• Issued: 10/05/2004
• 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., Milo, Charles F., Hansen, Gerald, Gresl, Charles, Selmon, Matthew R., Wynne, Robert L., Hill, E. Richard III
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/835,043
• Publication Number:
  US 20010018596A1
• Time in Patent Office: 1,271 Days
• Field of Search: 606/1, 606/159, 606/198, 606/190, 604/104, 600/207
• US Class Current: 606/198
• 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 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• 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 catheter for treating a vascular occlusion, comprising:

an elongated shaft including a proximal section and a distal section, and at least one lumen extending from the proximal section to the distal section;

two spreading members at the distal section of the elongated shaft, wherein each of the spreading members comprises a free distal end that moves laterally away from a longitudinal axis of the elongated shaft to disrupt the vascular occlusion; and

an actuating assembly positioned along the elongated shaft to move the free distal ends of the two spreading members laterally in response to an actuation force, wherein the free distal ends of the spreading members are configured to apply a fracturing force to tissue including at least one of tissue of a blood vessel and tissue of the vascular occlusion and configured to support advancing the catheter through the tissue so that the tissue remains external to the catheter.

2. The catheter as recited in claim 1, wherein each of the two spreading members includes a cam follower on an interior of the spreading member.

3. The catheter as recited in claim 2, wherein the actuating assembly includes an actuation element including a distal end with a cam, wherein the cam is in contact with the cam follower to urge the spreading member in a substantially lateral direction.

4. The catheter as recited in claim 3, wherein the cam is configured as a central hub, and wherein the spreading member is urged in a substantially lateral direction when the cam is moved in a relatively proximal direction.

5. The catheter as recited in claim 3, wherein the cam is formed with an edge that slidably contacts the cam follower, and wherein the spreading member is urged in a substantially lateral direction when the cam is moved in a relatively distal direction.

6. The catheter as recited in claim 1, wherein the spreading member includes a substantially curved end.

7. The catheter as recited in claim 1, wherein the spreading member includes a substantially tapered end.

8. An intravascular tissue expanding catheter, comprising:

a catheter shaft formed of braided material, wherein the catheter shaft comprises at least one conduit extending along a longitudinal axis of the catheter shalt;

a housing formed at a distal end of the catheter shaft, wherein the housing includes two deflecting members that each comprise a free distal tip that moves in a lateral direction away from the longitudinal axis of the catheter shaft to expand intravascular tissue; and

an actuation assembly that moves the distal tips of the two deflecting members away from the longitudinal axis of the catheter shaft, wherein the distal tips of the deflecting members are configured to apply a fracturing force to the intravascular tissue including at least one of tissue of a blood vessel and tissue of the vascular occlusion and configured to support advancing the catheter through the intravascular tissue so that the intravascular tissue remains external to the catheter.

9. A catheter as in claim 8, wherein the two deflecting members each include an integrally formed hinge about which the distal tip of the deflecting member rotates.

10. A catheter as in claim 8, wherein the two deflecting members are each coupled to a discrete hinge about which the distal tip of the deflecting member rotates.

11. A catheter as in claim 8, wherein each of the two deflecting members includes an internal cam follower.

12. A catheter as in claim 11, wherein the actuation assembly includes a cam positioned within the housing for slidable movement along the cam followers of the two deflecting members to move the distal tips of the two deflecting members in a lateral direction.

13. A catheter as in claim 8, wherein the actuation assembly includes at least one pulling element coupled to the two deflecting members.

14. A catheter for use in vasculature, comprising:

a catheter body comprising at least one conduit extending through the catheter body;

two tissue expanding members coupled to a distal section of the catheter body, wherein each of the two tissue expanding members includes a proximal portion and a distal portion, and wherein the distal portion is free to move away from a longitudinal axis of the catheter body relative to the proximal portion; and

an actuation assembly within the catheter body such that when the actuation assembly contacts the two tissue expanding members, the distal portions of the expanding members move away from the longitudinal axis, wherein the expanding members are configured to apply a fracturing force to tissue including at least one of tissue of a blood vessel and tissue of a vascular occlusion and configured to support advancing the catheter through the tissue so that the tissue remain external to the catheter.

15. An intravascular catheter, comprising:

a catheter shaft including a distal end and a longitudinal axis having at least one lumen extending along the longitudinal axis of the catheter shaft;

an assembly at the distal end of the catheter shaft including two deflecting members each defined by a free distal tip that moves in a lateral direction away from the longitudinal axis of the catheter shaft to expand vascular tissue, wherein the two deflecting members are hinged to the catheter shaft; and

an actuating assembly positioned along the catheter shaft, the proximal movement of which moves the distal tip of the two deflecting members away from the longitudinal axis of the catheter shaft, wherein the deflecting members are configured to apply a fracturing force to tissue including at least one of tissue of a blood vessel and tissue of a vascular occlusion in the blood vessel and configured to support advancing the catheter through the tissue so that the tissue remains external to the catheter.