Methods and devices for cutting tissue

• US 9,486,237 B2
• Filed: 07/12/2013
• Issued: 11/08/2016
• Est. Priority Date: 08/19/1999
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Simpson, John B., Rosenthal, Michael H., Patel, Himanshu, Venegas, Gautama B.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US13/940,430
• Publication Number:
  US 20140163591A1
• Time in Patent Office: 1,215 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• 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 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• 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

Abstract

A method of removing material from a blood flow lumen generally includes providing a device having a cutting element and an opening, advancing the device through the blood flow lumen to a site where material is to be removed, forcing the opening toward a wall of the site where material is to be removed, and moving the cutting element and the opening so that material in the blood flow lumen is cut by the cutting element and directed into the opening for removal as the cutting element and opening are moved through the blood flow lumen. In some embodiments, the device may be deflected or bent to force the opening toward a wall to remove material. The cutting element may be rotatable and may have an axis that is movable, that is not parallel to the longitudinal axis of the device, or both.

Claims

1. An atherectomy catheter comprising:

a catheter body adapted to be inserted into a blood vessel of a subject, the catheter body including a proximal body portion and a distal body portion coupled to the proximal body portion at a joint, wherein the distal body portion is deflectable about the joint relative to the proximal body portion between a non-deflected position and a deflected position, the distal body portion having a side opening window;

a cutter in the distal body portion, the cutter being rotatable relative to the catheter body about a rotation axis and adapted to debulk the blood vessel, wherein the cutter is movable axially relative to the distal body portion from a distal location distal of the side opening window to a proximal location adjacent a proximal end of the side opening window to impart deflection of the distal body portion from the non-deflected position to the deflected position, wherein the cutter protrudes outside the distal body portion through the side opening window when the distal body portion is in the deflected position; and

a drive shaft extending within the proximal body portion, the drive shaft being coupled to the cutter and adapted to impart rotation to the cutter about the rotation axis and axial movement of the cutter relative to the distal body portion from the distal location to the proximal location.

2. The atherectomy catheter of claim 1, wherein each of the proximal and distal portions has a longitudinal axis, wherein in the deflected position of the distal body portion, the longitudinal axis of the distal body portion extends at a deflection angle relative to the longitudinal axis of the proximal body portion at the joint.

3. The atherectomy catheter of claim 2, wherein the deflection angle is greater than 0 degrees and less than or equal to 30 degrees.

4. The atherectomy catheter of claim 2, wherein the deflection angle is between 5 degrees and 20 degrees.

5. The atherectomy catheter of claim 2, wherein the deflection angle is between 5 degrees and 10 degrees.

6. The atherectomy catheter of claim 1, wherein the distal body portion comprises a rigid housing, wherein the proximal body portion comprises a flexible body portion, wherein the rigid housing defines the side opening window and is pivotably coupled to the proximal body portion at the joint.

7. The atherectomy catheter of claim 1, wherein the joint is proximal of the side opening window.

8. The atherectomy catheter of claim 1, wherein the cutter has a distal portion defining a cutting edge, wherein the cutting edge protrudes through the side opening window when the distal body portion is in the deflected position.

9. The atherectomy catheter of claim 8, wherein the cutting edge of the cutter is an annular cutting edge.

10. The atherectomy catheter of claim 1, wherein each of the proximal and distal portions has a longitudinal axis the longitudinal axis of the distal body portion is aligned with the longitudinal axis of the proximal body portion at the joint when the distal body portion is in the non-deflected position, and the longitudinal axis of the distal body portion is angularly offset from the longitudinal axis of the proximal body portion at the joint when the distal body portion is in the deflected position.

11. The atherectomy catheter of claim 1, wherein the distal body portion has an outer diameter adjacent the side opening window, wherein the cutter protrudes out of the side opening window an exposure distance beyond the outer diameter adjacent the side opening window when the distal body portion is in the deflected position.

12. The atherectomy catheter of claim 11, wherein the exposure distance is between about 0.025 mm and about 0.016 mm.

13. The atherectomy catheter of claim 11, wherein the exposure distance is between about 0.025 mm and about 0.64 mm.

14. The atherectomy catheter of claim 1, wherein the distal body portion comprises a collection chamber for collecting tissue removed from the blood vessel by the cutter.

15. The atherectomy catheter of claim 1, wherein the proximal body portion comprises a flexible torque tube.

16. The atherectomy catheter of claim 15, wherein the distal body portion comprises a rigid housing defining the side opening window.

17. The atherectomy catheter of claim 1, wherein the distal body portion is configured to urge the cutter toward a wall of the body lumen when the distal body portion is in the deflected position.

18. The atherectomy catheter of claim 1, wherein the distal body portion is selectively deflectable about the joint relative to the proximal body portion without deforming the distal body portion at the joint.

19. The atherectomy catheter of claim 1, wherein the joint comprises two pivot points on opposite sides of the cutter.

20. The atherectomy catheter of claim 1, wherein the joint comprises a pivot point proximal of the side opening window.

21. The atherectomy catheter of claim 1, further comprising an imaging device coupled to the cutter and adapted to image the blood vessel.

22. The atherectomy device set forth in claim 21, wherein the imaging device comprises an optical coherence tomography device.

23. The atherectomy catheter of claim 1, wherein the joint defines a pivot axis that is substantially orthogonal to the longitudinal axis of the proximal body portion, wherein the cutter is adapted to impart pivoting movement of the distal body portion about the pivot axis relative to the proximal body portion when moved axially from the distal location to the proximal location.

24. The atherectomy catheter set forth in claim 1, wherein the cutter is adapted to impart deflection of the distal body portion relative to the proximal body portion from the deflected position to the non-deflected position as the cutter moves distally relative to the distal body portion from the proximal location to the distal location, wherein an entirety of the cutter is inside the distal body portion when the distal body portion is in the non-deflected position.

25. The atherectomy catheter set forth in claim 1, wherein the rotation axis of the cutter is disposed at an offset angle relative to a longitudinal axis of the distal body portion when the distal body portion is in the deflected position.

26. The atherectomy catheter set forth in claim 25, wherein the rotation axis of the cutter is aligned with the longitudinal axis of the distal body portion when the distal body portion is in the non-deflected position.

27. An atherectomy catheter comprising:

a catheter body adapted to be inserted into a blood vessel of a subject, the catheter body including a proximal body portion and a distal body portion coupled to the proximal body portion, wherein the distal body portion is deflectable relative to the proximal body portion between a non-deflected position and a deflected position, wherein the distal body portion has a longitudinal axis, the distal body portion having a side opening window;

a cutter in the distal body portion, the cutter being rotatable relative to the catheter body about a rotation axis and adapted to debulk the blood vessel, wherein the cutter is movable axially relative to the distal body portion from a distal location distal of the side opening window to a proximal location adjacent a proximal end of the side opening window to impart deflection of the distal body portion from the non-deflected position to the deflected position, wherein the rotation axis of the cutter is disposed at an offset angle relative to the longitudinal axis of the distal body portion when the distal body portion is in the deflected position.

28. The atherectomy catheter set forth in claim 27, wherein the rotation axis of the cutter is aligned with the longitudinal axis of the distal body portion when the distal body portion is in the non-deflected position.

29. The atherectomy catheter set forth in claim 27, wherein the cutter protrudes outside the distal body portion through the side opening window when the distal body portion is in the deflected position.

30. The atherectomy catheter set forth in claim 27, further comprising a drive shaft extending within the proximal body portion, the drive shaft being coupled to the cutter and adapted to impart rotation to the cutter about the rotation axis and axial movement of the cutter relative to the distal body portion.