Atherectomy catheters and occlusion crossing devices

• US 10,470,795 B2
• Filed: 11/17/2016
• Issued: 11/12/2019
• Est. Priority Date: 02/06/2014
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Patel, Himanshu N., Simpson, John B., Lam, Wendy Ngo
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/354,842
• Publication Number:
  US 20170065295A1
• Time in Patent Office: 1,090 Days
• Field of Search: 606159, 604 22
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00738 part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Atherectomy catheter devices having a C-shaped balloon opposite a cutting window out of which a rotating cutter may extend and a proximal annular balloon. The C-shaped first balloon may be used to drive the cutter against a vessel and to deploy the cutter by assisting in deflecting a nosecone (distal tip) to expose the distal-facing cutting edge of the cutter. The proximal annular balloon may be used to occlude blood flow. The device may pulled, pushed or rotated in a vessel with the balloons inflated or deflated.

Claims

1. An atherectomy catheter device, the device comprising:

an elongate body extending distally to proximally along a longitudinal axis;

a nosecone extending from a distal end of the elongate body, wherein the nosecone is hinged to the elongate body at a hinge region on first lateral side of the device;

a cutting assembly having a distal cutting edge;

a cutting window on the first lateral side of the device at a proximal end of the nosecone through which the distal cutting edge may be exposed;

a balloon configured to urge the distal cutting edge against a vessel wall, wherein the balloon is coupled proximally of the hinge region on the elongate body and coupled distally of the cutting window on the nosecone, so that the balloon does not extend over the cutting window; and

wherein the balloon, when inflated, has a C-shaped cross-sectional profile and a radius of curvature that is larger than a radius of curvature of the cutting assembly.

2. The atherectomy catheter device of claim 1, wherein the cutting assembly is a cutting and imaging assembly and comprises an imaging sensor thereon.

3. The atherectomy catheter device of claim 1, wherein the hinge region is a hinge point on the first lateral side of the elongate body.

4. The atherectomy catheter device of claim 1, wherein the balloon is coupled proximally of the hinge region on the elongate body by wrapping around 50% or more of the circumference of the elongate body.

5. The atherectomy catheter device of claim 1, wherein the balloon is coupled distally of the cutting window on the nosecone by wrapping around 50% or more of the circumference of the nosecone.

6. The atherectomy catheter device of claim 1, wherein the balloon is configured to displace the nosecone relative to the elongate body to expose the distal cutting edge when inflated.

7. The atherectomy catheter device of claim 1, further comprising a guidewire lumen extending within the balloon for an entire longitudinal length of the balloon.

8. The atherectomy catheter device of claim 1, wherein the cutting assembly is a cutting and imaging assembly and comprises an optical coherence tomography imaging sensor.

9. The atherectomy catheter device of claim 1, wherein proximal or distal movement of a drive shaft within the elongate body causes the nosecone to move off-axis relative to the elongate body about the hinge region to expose the distal cutting edge through the cutting window.

10. The atherectomy catheter device of claim 1, wherein an inflation pressure of the balloon is less than 2 psi.

11. The atherectomy catheter device of claim 1, wherein the balloon has a tapered distal end and a tapered proximal end.

12. The atherectomy catheter device of claim 1, wherein a longitudinal center of the balloon is opposite the cutting window.

13. The atherectomy catheter device of claim 1, wherein the balloon is opposite the distal cutting edge of the cutting assembly when the distal cutting edge is exposed through the window.

14. An atherectomy catheter device, the device comprising:

an elongate body extending distally to proximally along a longitudinal axis;

a nosecone extending from a distal end of the elongate body, wherein the nosecone is hinged at a hinge region to the elongate body on a first lateral side of the elongate body;

a cutting and imaging assembly having an imaging sensor thereon and a distal cutting edge; and

a balloon configured to urge the distal cutting edge against a vessel wall, wherein the balloon is coupled to the elongate body at a proximal end and to the nosecone at a distal end, wherein the balloon, when inflated, has a C-shaped profile and a radius of curvature that is larger than a radius of curvature of the cutting and imaging assembly.

15. The atherectomy catheter device of claim 14, wherein the balloon is further configured to displace the nosecone relative to the elongate body to expose the distal cutting edge when the balloon is inflated.

16. The atherectomy catheter device of claim 14, further comprising a guidewire lumen extending within the balloon for an entire longitudinal length of the balloon.

17. The atherectomy catheter device of claim 14, wherein the imaging sensor is an optical coherence tomography imaging sensor.

18. The atherectomy catheter device of claim 14, wherein proximal or distal movement of a drive shaft within the elongate body causes the nosecone to move off-axis relative to the elongate body about the hinge region to expose the distal cutting edge through a cutting window.

19. The atherectomy catheter device of claim 14, wherein an inflation pressure of the balloon is less than 2 psi.

20. The atherectomy catheter device of claim 14, wherein the balloon has a tapered distal end and a tapered proximal end.

21. The atherectomy catheter device of claim 14, wherein the balloon is opposite a lateral opening in a side of the catheter device between the hollow distal tip and the elongate body.

22. The atherectomy catheter device of claim 14, wherein the balloon is opposite the distal cutting edge when the nosecone bends away from the elongate body to expose the distal cutting edge.

23. An atherectomy catheter device, the device comprising:

an elongate body extending distally to proximally along a longitudinal axis;

a hollow nosecone extending from a distal end of the elongate body, wherein the nosecone is hinged at a hinge region to the elongate body on a first lateral side of the elongate body;

a cutting and imaging assembly having an optical coherence tomography (OCT) imaging sensor thereon and a distal cutting edge;

a cutting window on the first lateral side at a proximal end of the nosecone through which the distal cutting edge may be exposed; and

a balloon configured to urge the distal cutting edge against a vessel wall, wherein the balloon is coupled proximally of the hinge region on the elongate body by wrapping around half or more of the circumference of the elongate body, and coupled distally of the cutting window on the hollow nosecone by wrapping around half or more of the circumference of the nosecone, so that the balloon does not extend over the cutting window;

wherein the balloon, when inflated, has a C-shaped cross-sectional profile perpendicular to the longitudinal axis and a radius of curvature that is larger than a radius of curvature of the cutting and imaging assembly.