SYSTEMS, METHODS AND DEVICES FOR ABLATION, CROSSING, AND CUTTING OF OCCLUSIONS

• US 20110054503A1
• Filed: 09/30/2009
• Published: 03/03/2011
• Est. Priority Date: 09/02/2009
• Status: Active Grant

• Current Assignee: ReFlow Medical Inc.
• Original Assignee: ReFlow Medical Inc.
• Inventors: RIZK, Isa, Fulkerson, John
• Granted Patent: US 9,204,893 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Ablation, crossing, and cutting systems, devices and associated methods, including a crossing device, comprising, in combination: a spring-enhanced handle and body configured to controllably extend and retract a blade within a microcatheter for addressing an occlusion within a vessel of a patient to provide improved access for supplemental treatment and reperfusion.

Claims

1. A crossing device, comprising, in combination:

a body coupled to a microcatheter at a proximal end of the microcatheter;

a handle coupled to a blade at a proximal end of the blade, the blade disposed within a lumen of the microcatheter; and

a spring configured to compress as the handle is advanced relative to the body;

wherein a sharpened tip of the blade is configured to advance from a natural position within the lumen of the microcatheter to an extended position beyond a distal end of the microcatheter as the handle is advanced relative to the body;

wherein the spring is configured to expand and retract the blade relative to the microcatheter as the handle is released.

2. The device of claim 1, further comprising a luer configured to attach to a proximal end of the handle and provide adaptable use of a supplemental treatment device in combination with the crossing device.

3. The device of claim 2, wherein the luer is configured to guide a supplemental treatment device to the lumen of the microcatheter.

4. The device of claim 2, wherein the luer is configured to guide a supplemental treatment device to a lumen of the blade.

5. The device of claim 2, wherein the supplemental treatment device is at least one of:

a guidewire, a PTA balloon, and a stent device.

6. The device of claim 1, wherein the tip of the blade is disposed at a distal end of the blade and is of a rigid material.

7. The device of claim 1, wherein the tip of the blade is a hollow, sharpened, everted tip.

8. The device of claim 1, wherein the handle and the body are configured to limit the expansion of the spring and provide the natural position of the blade and further configured to selectively lock the blade in at least one of the natural position and the extended position.

9. The device of claim 1, wherein the body further comprises a nose detachable from the body and secured to the microcatheter, such that the microcatheter is selectively removable from the body.

10. The device of claim 1, wherein the lumen of the microcatheter further comprises guiding members configured to provide torque to the blade as the blade is advanced from the natural position to the extended position.

12. The method of claim 6, whereby the blade is retracted by a spring between the handle and the body.

13. The method of claim 6, wherein the method results in reconfiguration of at least a portion of the occlusion, whereby a different flow condition is achieved.

14. The method of claim 6, further comprising:

advancing the microcatheter and the blade through a channel created by advancement of the blade to an extended position.

15. The method of claim 6, further comprising:

providing a supplemental treatment device to the occlusion through a lumen of the blade.

16. The method of claim 15, wherein the supplemental treatment device is at least one of a guidewire, a PTA balloon, and a stent device.

11. An improved surgical method for addressing blockage within a vessel, comprising, in combination:

delivering an apparatus including at least a microcatheter to a desired treatment situs;

positioning the microcatheter having at least a blade proximate to a surface of an occlusion, wherein the microcatheter is attached to a body and comprises a lumen;

providing the blade within the lumen of the microcatheter to the surface of the occlusion, wherein the blade is attached to a handle;

advancing the blade to an extended position by manipulation of the handle relative to the body; and

retracting the blade to a natural position by releasing the handle.

17. A kit, which comprises:

a crossing device further comprising;

a body coupled to a microcatheter at a proximal end of the microcatheter;

a handle coupled to a blade at a proximal end of the blade, the blade disposed within a lumen of the microcatheter;

wherein a sharpened tip of the blade is configured to advance from a natural position within the lumen of the microcatheter to an extended position beyond a distal end of the microcatheter as the handle is advanced relative to the body; and

directions for use.

18. The kit of claim 17, further comprising:

a supplemental treatment device configured to be advanced within the lumen of the microcatheter.

19. The kit of claim 18, further comprising a luer disposed at a proximal end of the handle and configured to guide the supplemental treatment device into the lumen of the microcatheter.

20. The kit of claim 18, wherein the supplemental treatment device is at least one of:

a guidewire, a PTA balloon, and a stent device.