High Torque, Low Profile Catheters and Methods for Transluminal Interventions

• US 20080125748A1
• Filed: 09/25/2006
• Published: 05/29/2008
• Est. Priority Date: 09/25/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Patel, Kaushik
• Granted Patent: US 8,636,715 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

Catheter devices having low profile shafts and laterally deployable members (e.g., cannulas, needles, etc.) that may be extended or advanced laterally from the catheter shaft. Also disclosed are methods for bypassing a vascular obstruction (e.g., a chronic total occlusion or other full or partial obstruction) wherein a guidewire is entrapped in a subintimal space adjacent to the obstruction. A catheter of the foregoing character is advanced over the entrapped guidewire and into the subintimal space. The laterally deployable member is then advanced or extended from the subintimal space back into the true lumen of the blood vessel distal to the obstruction. A second guidewire is then advanced through or along the laterally deployable member. The catheter and first guidewire are then removed and one or more working device(s) (balloons, atherectomy devices, setnts, etc.) is/are advanced over the second guidewire and used to establish a subintimal bypass channel through which blood may flow around the obstruction.

Claims

1. A catheter device comprising:

an elongate catheter body, at least a portion of which comprises a) a core member having at least one lumen extending therethrough, b) a substantially cylindrical braided layer disposed about the core member and c) an outer layer disposed about said braided layer; and

a laterally deployable member that is advanceable or extendable laterally from the catheter body.

2. A device according to claim 1 wherein the core member comprises a material selected from the group consisting of machined or extruded polymers, polyethylene, high density polyethylene, ultra-high molecular weight polyethylene and polypropylene.

3. A device according to claim 1 wherein the braided layer comprises a braided material selected from the group consisting of metal ribbons, polymer fibers or filaments and wires.

4. A device according to claim 1 wherein the outer layer comprises a material selected from the group consisting of polymeric materials, metals and woven materials.

5. A device according to claim 1 wherein a side port if formed in the catheter body and wherein the laterally deployable member is advanceable out of said side port.

6. A device according to claim 1 wherein the laterally deployable member has a lumen extending therethrough.

7. A device according to claim 1 wherein the laterally deployable member has a distal tip that will penetrate through tissue.

8. A device according to claim 1 wherein the laterally deployable member comprises a cannula.

9. A device according to claim 1 wherein the laterally deployable member comprises a needle.

10. A device according to claim 1 wherein the laterally deployable member is moveable back and forth between a retracted position wherein it is substantially within the catheter body and an extended position wherein it extends laterally from the catheter body.

11. A device according to claim 10 further comprising a substantially tubular housing within which at least a portion of the laterally deployable member resides when in its retracted position.

12. A device according to claim 11 the housing comprises a curved housing and wherein the laterally deployable member is biased to a curved configuration.

13. A device according to claim 12 wherein the laterally deployable member exits from a side opening in the catheter body and the housing is curved in the direction of said side opening.

14. A device according to either of claims 12 or 13 wherein the housing is radiographically imageable.

15. A device according to claim 1 further comprising at least one imageable marker which generally indicates the direction in which the laterally deployable member will advance or extend from the catheter body.

16. A device according to claim 1 wherein the core member has a first lumen and a second lumen.

17. A device according to claim 16 wherein the first lumen has a side opening and wherein the laterally deployable member is moveable from a retracted position within the first lumen to an extended position where it extends out of the side opening.

18. A device according to claim 16 wherein the second lumen is useable as a guidewire lumen for tracking the catheter device over a guidewire.

19. A device according to claim 1 wherein the core member comprises an extruded polymer member.

20. A device according to claim 1 wherein at least the core member is formed substantially of a material selected form the group consisting of:

polyethylene, high density polyethylene, ultra-high molecular weight polyethylene or polypropylene.

21. A device according to claim 1 or 20 wherein the catheter body has an outer diameter of from about 0.067 inch to abut 0.080 inch.

22. A device according to claim 1 or 20 wherein the catheter body is sized to pass through a 6 French introducer.

23. A device according to claim 1 or 20 wherein a lumen of the core member is devoid of any liner.

24. A method for bypassing an obstruction in a blood vessel that has a true lumen and a vessel wall, and wherein the vessel wall has an intima, said method comprising the steps of:

(A) advancing a first guidewire through into the blood vessel such that a distal portion of the first guidewire becomes positioned within a subintimal space adjacent to the obstruction;

(B) providing a catheter device that comprises

i) an elongate catheter body having a distal end, at least a portion of said catheter body comprising a) a core member having at least one lumen extending therethrough, b) a substantially cylindrical braided layer disposed about the core member and c) an outer layer disposed about said braided layer; and

ii) a laterally deployable member that has a retracted position and an extended position;

(C) advancing the catheter body over the first guidewire such that the distal end of the catheter body becomes positioned within the subintimal space;

(D) advancing or extending the laterally deployable member from the catheter body into the true lumen of the blood vessel, distal to the obstruction;

(E) advancing a second guidewire through the lumen of the laterally deployable member and into the true lumen of the blood vessel, distal to the obstruction;

(F) retracting the laterally deployable member;

(G) removing the catheter device and the first guidewire, leaving the second guidewire in place such that it extends through the true lumen of the blood vessel proximal to the obstruction, through the subintimal space and back into the true lumen of the blood vessel distal to the obstruction; and

(H) advancing at least one working device over the second guidewire and using said at least one working device to modify the subintimal space to create a patent bypass channel through which blood may flow around the obstruction.

25. A method according to claim 24 wherein the obstruction is a chronic total occlusion of at least one artery.

26. A method according to claim 25 wherein the at least one artery is at least one peripheral artery.

27. A method according to claim 26 wherein the at least one peripheral artery is the iliac artery, the femoral artery, the popliteal artery or a segment of vasculature that includes portion of the femoral and popliteal arteries.

28. A method according to claim 25 wherein the artery is a coronary artery.

29. A method according to claim 24 wherein the catheter device further comprises at least one imageable marker that indicates the direction or trajectory on which the laterally deployable member will advance or extend from the catheter body and wherein Step D further comprises:

imaging the imageable marker and using the resultant image of said marker to make any necessary adjustment of the rotational orientation of the catheter body to thereby increase the likelihood that the laterally deployable member will subsequently advance or extend into the true lumen of the blood vessel rather than to some other location.

30. A method according to claim 24 wherein the catheter device provided in Step D further comprises a housing within which at least a distal portion of the laterally deployable member resides while in its retracted position, said housing being imageable and shaped in a manner that indicates the direction in which the laterally deployable member will extend or advance from the catheter body, and wherein Step D further comprises:

imaging the housing and using the resultant image of said housing to make any necessary adjustment of the rotational orientation of the catheter body to increase the likelihood that the laterally deployable member will subsequently advance or extend into the true lumen of the blood vessel rather than to some other location.

31. A method according to claim 24 wherein Step H comprises advancing a balloon over the second guidewire and using the balloon to dilate the subintimal space.

32. A method according to claim 24 wherein Step H comprises advancing an atherectomy device over the second guidewire and using the atherectomy device to enlarge the subintimal space.

33. A method according to claim 24 wherein Step H comprises advancing a stent over the second guidewire and causing the stent to expand within the subintimal space.