Method and apparatus for treating vascular occlusions

• US 6,638,247 B1
• Filed: 03/29/2000
• Issued: 10/28/2003
• 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., Hansen, Gerald, Hill, E. Richard III
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): PHANIJPHAND, GWEN G
• Application Number:
  US09/538,441
• Time in Patent Office: 1,308 Days
• Field of Search: 604/104, 604/96.01, 606/189, 606/198, 606/159
• US Class Current: 604/104
• 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
• 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, wherein the shaft is formed with at least one lumen extending from the proximal section to the distal section;

at least one spreading member formed at the distal section of the shaft, wherein the at least one spreading member comprises a free distal end that moves through an arc away from the longitudinal axis of the shaft with respect to a fixed pivotal position of a proximal end of the spreading member to disrupt a vascular occlusion, wherein the at least one spreading member includes a relatively interior portion formed with a cam follower; and

an actuating assembly positioned along the elongated shaft to move the free distal end of the at least one spreading member in response to an actuation force, wherein the actuating assembly includes an actuation element including a distal end and a cam formed at the distal end for communication with the cam follower.

2. The catheter of claim 1, wherein the cam is configured as a central hub that slidably contacts the cam follower formed on the interior portion of the at least one spreading member when the cam is moved in a relatively proximal direction to move the distal most end of the at least one spreading member in a substantially lateral direction.

3. The catheter of claim 1, wherein the cam is formed with a cam edge that slidably contacts the cam follower formed on the interior portion of the at least one spreading member when the cam is moved in a relatively distal direction to move the distal most end of the at least one spreading member in a substantially lateral direction.

4. The catheter of claim 1, wherein the distal section of the elongated shaft includes a nosecone.

5. The catheter of claim 1, wherein the distal section of the elongated shaft includes a hub defined by an external surface, wherein a collar section is fitted around the external surface of the hub.

6. The catheter of claim 1, wherein the at least one spreading member includes at least two hinged spreading members joined to the collar section as a unitary body.

7. The catheter of claim 1, wherein the at least one spreading member is defined by a substantially curved end.

8. The catheter of claim 1, wherein the at least one spreading member is defined by a substantially tapered end.

9. The catheter of claim 1, wherein the at least one spreading member is defined by a substantially pointed end.

10. An intravascular tissue expanding catheter, comprising:

a catheter shaft including a distal end and a longitudinal axis having at least one conduit extending along the longitudinal axis,

a housing formed at the distal end of the catheter shaft wherein the housing includes at least one deflecting member defined by a proximal end pivotally coupled to the catheter shaft and a free distal tip that moves through an arc away from the longitudinal axis of the shaft to expand vascular tissue, wherein the at least one deflecting member includes an integrally formed hinge; and

an actuation assembly positioned along the catheter shaft to move the distal tip of at least one deflecting member away from the longitudinal axis of the catheter shaft.

11. The intravascular catheter of claim 10, wherein the at least one deflecting member includes a plurality of hinges.

12. The intravascular catheter of claim 10, wherein the actuation assembly includes a pulling element connected to the at least one deflecting member.

13. The intravascular catheter of claim 12, wherein the at least one deflecting member is connected to the housing with a at least one hinge pin to form a at least one hinge that supports rotation of the at least one deflecting member when the pulling element is pulled in a relatively proximal direction.

14. An intravascular tissue expanding catheter, comprising:

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

a housing formed at the distal end of the catheter shaft wherein the housing includes at least one deflecting member defined by a proximal end pivotally coupled to the catheter shaft and a free distal tip that moves through an arc away from the longitudinal axis of the shaft to expand vascular tissue, wherein the at least one deflecting member is formed with an internal cam follower; and

an actuation assembly positioned along the catheter shaft to move the distal tip of at least one deflecting member away from the longitudinal axis of the catheter shaft.

15. The intravascular catheter of claim 14, wherein the actuation assembly includes a cam positioned within the housing for slidable movement along the cam follower of the at least one deflecting member to move the distal tip of the at least one deflecting member.

16. The intravascular catheter of claim 15, wherein the actuation assembly includes an actuation conduit formed along the catheter shaft and a push tube positioned relatively proximal to the cam follower within the actuation conduit.

17. The intravascular catheter of claim 15, wherein the actuation assembly includes an actuation conduit formed along the catheter shaft and a rotational tube positioned relatively proximal to the cam within the actuation conduit.

18. The intravascular catheter of claim 15, wherein the actuation assembly includes an actuation conduit formed along the catheter shaft and a pulling element positioned relatively proximal to the cam follower within the actuation conduit.

19. An intravascular tissue expanding catheter comprising:

a catheter shaft including a distal end and a longitudinal axis having at least one conduit extending alone the longitudinal axis, wherein the catheter shaft is defined by an external surface and a guidewire conduit is formed within the external surface of the catheter shaft, wherein the guidewire conduit is formed offset from the longitudinal axis of the catheter shaft;

a housing formed at the distal end of the catheter shaft, wherein the housing includes at least one deflecting member defined by a proximal end pivotally coupled to the catheter shaft and a free distal tip that moves through an arc away from the longitudinal axis of the shaft to expand vascular tissue; and

an actuation assembly Positioned along the catheter shaft to move the distal tip of at least one deflecting member away from the longitudinal axis of the catheter shaft.

20. An intravascular tissue expanding catheter, comprising:

a catheter shaft include a distal end and a longitudinal axis having at least one conduit extending along the longitudinal axis, wherein the catheter shaft is defined by an external surface and a guidewire conduit is formed along the external surface of the shaft;

a housing formed at the distal end of the catheter shafts wherein the housing includes at least one deflecting member defined by a proximal end pivotally coupled to the catheter shaft and a free distal tip that moves through an arc away from the longitudinal axis of the shaft to expand vascular tissue; and

an actuation assembly positioned along the catheter shaft to move the distal tip of at least one deflecting member away from the longitudinal axis of the catheter shaft.

21. An intravascular catheter for use in vasculature, comprising:

a catheter body that includes a distal section and at least one conduit, wherein the distal section includes a fixed extension;

at least one tissue expanding member connected to the distal section of the catheter body, wherein the tissue expanding member includes a proximal portion and a distal portion wherein the proximal portion is connected to the fixed extension with a hinge pin so that the distal portion is free and configured to move through an arc away from the longitudinal axis of the catheter body relative to the fixed pivotal position of the proximal portion of the tissue expanding member;

an actuation assembly positioned within the catheter body in communication with the tissue expanding member to move the distal portion of the tissue expanding member, wherein the actuation assembly includes an actuation member coupled to the proximal portion of the tissue expanding member with an actuation member attachment; and

a guidewire lumen positioned between the hinge pin and the actuation member attachment within the distal section of the catheter body.

22. The intravascular catheter of claim 21, further comprising a guidewire tube extension defined by an outer surface positioned along at least a portion of the fixed extension for enclosing a guidewire.

23. The intravascular catheter of claim 22, wherein the at least one tissue expanding member is formed with a surface that is complementary to the outer surface of the guidewire tube extension.