METHOD AND APPARATUS FOR PLACING A CATHETER WITHIN A VASCULATURE

• US 20140207179A1
• Filed: 03/24/2014
• Published: 07/24/2014
• Est. Priority Date: 06/26/2007
• Status: Active Grant

• Current Assignee: Roxwood Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: Roxwood Medical, Inc. (Boston Scientific Corporation)
• Inventors: FARHANGNIA, Mehrdad, MILLER, John, TABER, Mark, YANG, Mark C.
• Granted Patent: US 9,125,683 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter for insertion into vasculature of a patient to a target area in the vasculature includes a hollow inner shaft, a non-occluding self-expandable scaffold coupled to the distal end of the inner shaft and disposed at the distal end of the inner shaft, and a hollow outer shaft. The outer shaft is slidable over the inner shaft and scaffold such that the scaffold is in a non-expanded state when the outer shaft is around the scaffold. The outer shaft has a state where the distal end of the outer shaft remains near the target area without the inner shaft and the scaffold being within the outer shaft. The inner shaft and the scaffold are removable through the proximal end of the outer shaft while the distal end of the outer shaft remains near the target area.

Claims

1. A catheter apparatus for insertion into vasculature of a patient and to a target area in the vasculature, comprising:

a hollow inner shaft with a distal end and a proximal end;

a non-occluding self-expandable scaffold coupled to the distal end of the inner shaft and disposed at the distal end of the inner shaft, a portion of the distal end of the inner shaft being disposed at least in part inside the self-expandable scaffold; and

a hollow outer shaft with a distal end and a proximal end, the outer shaft being slidable over the inner shaft and the scaffold such that the scaffold is in a non-expanded state when the outer shaft is disposed around the scaffold, the outer shaft having a state where the distal end of the outer shaft remains near the target area without the inner shaft and the scaffold being disposed within the outer shaft,

wherein the inner shaft and the scaffold are configured to be removable through the proximal end of the outer shaft while the distal end of the outer shaft remains near the target area.

2. The catheter apparatus of claim 1, further comprising a microcatheter having a lumen, a distal opening, and a distal end.

3. The catheter apparatus of claim 2, wherein the outer shaft, the inner shaft, and the microcatheter are capable of being independently operable.

4. The catheter apparatus of claim 2, further comprising one or more guidewire, wherein the lumen of the microcatheter is configured to be moveable over at least one of the one or more guidewires.

5. The catheter apparatus of claim 2, wherein the microcatheter is configured to be removable through the proximal end of the inner shaft while the distal end of the outer shaft remains near the target area in the vasculature of the patient.

6. The catheter apparatus of claim 1, wherein the proximal end of the outer shaft has an opening adapted to slidably receive the inner shaft and the scaffold, and through which the inner shaft and the scaffold can be removed from the outer shaft while the distal end of the outer shaft remains near the target area in the vasculature.

7. The catheter apparatus of claim 2, wherein the proximal end of the inner shaft has an opening adapted to slidably receive the microcatheter, and through which the microcatheter can be removed from the inner shaft while the distal end of the outer shaft remains near the target area in the vasculature.

8. The catheter apparatus of claim 1, wherein at least a portion of the distal end of the inner shaft is disposed substantially along a central longitudinal axis of the scaffold.

9. The catheter apparatus of claim 1, wherein the scaffold comprises a distal end and a proximal end, one of the distal and proximal ends of the scaffold being slidable relative to the inner catheter.

10. The catheter apparatus of claim 1, wherein the self-expandable scaffold comprises at least one loop that projects inwardly from a cylindrical plane of the scaffold to a central longitudinal axis of the self-expandable scaffold.

11. The catheter apparatus of claim 1, wherein the outer shaft comprises a support catheter in the state where the distal end of the outer shaft remains near the target area without the inner shaft and the scaffold being disposed within the outer shaft.

12. The catheter apparatus of claim 11, wherein the support catheter is arranged to receive at least one additional medical device.

13. The catheter apparatus of claim 12, wherein the at least one additional medical device comprises at least one of a microcatheter and a balloon catheter.

14. The catheter apparatus of claim 9, wherein the distal end of the scaffold is arranged slideably around the inner shaft by an inverted portion of the scaffold, the inverted portion extending inwardly within the scaffold and closely around the inner shaft.

15. A method of using a catheter in a vessel of a patient for crossing a target area and providing support for a medical device, comprising:

inserting a catheter into a vessel such that a distal end of the catheter approaches a target area in the vessel, the catheter comprising;

a hollow shaft with a distal end and a proximal end,

a non-occluding self-expandable scaffold disposed at the distal end of the catheter, wherein a portion of the distal end of the catheter is disposed at least in part inside the scaffold, and

a sheath with a central lumen, a distal end having a distal opening, and a proximal end having a proximal opening, the sheath being slidable along the shaft,

wherein the scaffold is configured to be coupled to the distal end of the catheter, and

wherein the scaffold is in an un-expanded state when covered by the sheath;

withdrawing the sheath to expand the self-expandable scaffold;

moving the sheath and the scaffold structure relative to each other to position the sheath at least partially over the scaffold structure such that the scaffold returns to the un-expanded state; and

withdrawing the hollow shaft and the scaffold through the proximal opening of the sheath, the sheath being adapted to remain in the vessel as a support catheter such that a medical device may be passed through the proximal opening of the sheath and advanced through the sheath to the target area near the distal end of the sheath.

16. The method claim 15, further comprising inserting a microcatheter through the catheter before advancing the sheath over the scaffold structure to return the scaffold to the non-expanded state.

17. The method of claim 15, further comprising inserting a guidewire through the catheter until a distal end of the guidewire is disposed at the target area.

18. The method of claim 17, wherein inserting the guidewire further comprises advancing the guidewire through the target area.

19. The method of claim 17, wherein the distal end of the guidewire remains disposed at the target area after withdrawing the hollow shaft and the scaffold.

20. The method of claim 16, wherein the method further comprises advancing the microcatheter after withdrawing the sheath to expand the self-expandable scaffold, wherein the microcatheter is adapted to contact a chronic total occlusion.

21. The method of claim 15, wherein at least a portion of the distal end of the catheter is disposed substantially along a central axis of the self-expandable scaffold structure.

22. The method of claim 15, further comprising inserting a medical device through the proximal opening of the sheath and advancing the medical device through the sheath to the target area near the distal end of the sheath.

23. The method of claim 22, wherein advancing the medical device through the sheath to the target area includes the method being adapted to advance the medical device to an arterial branch that is off of a main trunk.

24. The method of claim 15, wherein the catheter is adapted to be inserted into an arterial branch that is off a main trunk.

25. The method of claim 15, wherein the target area is adapted to be one or more of proximate to a chronic total occlusion, and an arterial branch of the coronary artery.