Superelastic medical instrument

• US 10,285,574 B2
• Filed: 04/03/2018
• Issued: 05/14/2019
• Est. Priority Date: 04/07/2017
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Auris Health, Inc. (Johnson & Johnson)
• Inventors: Landey, Casey Teal, Connolly, Ryan Jeffrey
• Primary Examiner(s): Cerioni, Daniel L
• Application Number:
  US15/944,566
• Publication Number:
  US 20180289243A1
• Time in Patent Office: 406 Days
• Field of Search: 600567
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2034/302 specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

Certain aspects relate to a superelastic medical instrument that of bending elastically through the tortuous pathways of an endoscope, returning to a straight shape upon deployment from the endoscope, and deploying straight along the axis of the end of the bronchoscope (within a tolerated margin) to distances of 2 cm or more.

Claims

1. A biopsy needle assembly, comprising:

a needle formed from a superelastic alloy, the needle including;

a body portion extending from a distal end of the needle to a proximal end of the needle, and

an inner surface of the needle forming a lumen extending through at least a portion of the body portion to an opening in the distal end, wherein the lumen and the opening are configured to acquire a tissue biopsy;

an elongate member attached at the proximal end of the needle; and

a tubular jacket including an interior channel, wherein;

in a first configuration, the distal end of the needle is positioned within the interior channel, and

in a second configuration, in response to distal movement of the elongate member through the interior channel, the distal end of the needle is extended beyond a distal end of the tubular jacket;

wherein the elongate member comprises a polymer tube reflowed around an overlap region located at the proximal end of the needle; and

wherein the needle further comprises a plurality of surface features formed on the needle at the overlap region, wherein the polymer tube is reflowed around the surface features.

2. The assembly of claim 1, wherein the superelastic alloy comprises Nitinol.

3. The assembly of claim 1, wherein the needle has a wall thickness of approximately 0.0015 inches thick.

4. The assembly of claim 1, further comprising:

a sharpened tip at the distal end of the needle; and

a radiopaque material positioned around the needle near the sharpened tip.

5. The assembly of claim 4, wherein the radiopaque material has a thickness of at least 200 microinches.

6. The assembly of claim 1, wherein the polymer tube comprises a conical section at the polymer tube'"'"'s distal end prior to or after being reflowed around the overlap region.

7. The assembly of claim 1, wherein the needle has a length of approximately 5 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of approximately 2 centimeters.

8. The assembly of claim 1, wherein the needle has a length of approximately 4 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of approximately 1 centimeters.

9. The assembly of claim 1, wherein the needle has a length between 1 centimeter and 6 centimeters.

10. The assembly of claim 1, wherein the overlap region has a length of 0.5 cm to 3 cm.

11. The assembly of claim 1, wherein a channel formed by an interior surface of the polymer tube is in fluid communication with the lumen to provide pressure through the opening.

12. The assembly of claim 1, wherein the plurality of surface features comprise a grit blasted exterior surface of the needle.

13. The assembly of claim 1, wherein the plurality of surface features comprise laser cut holes each extending through a wall of the needle.

14. The assembly of claim 1, wherein the overlap region is located at a distal end of the tube, and wherein the proximal end of the needle includes a first spiral channel or cut, and the distal end of the tube includes a second spiral channel or cut structured to mechanically mate with the first spiral channel or cut.

15. The assembly of claim 1, wherein the overlap region is located at a distal end of the tube, and wherein the proximal end of the needle and the distal end of the tube are secured at the overlap region by a flexible adhesive.

16. The assembly of claim 1 wherein the overlap region is located at a distal end of the tube, and wherein the proximal end of the needle and the distal end of the tube are secured at the overlap region by screws.

17. The assembly of claim 1, wherein the superelastic alloy, in a martensite phase, deforms reversibly up to 10% from the original shape.

18. The assembly of claim 12, wherein the superelastic alloy comprises Nitinol.

19. The assembly of claim 12, wherein the needle has a wall thickness of approximately 0.0015 inches thick.

20. The assembly of claim 12, further comprising:

a sharpened tip at the distal end of the needle; and

a radiopaque material positioned around the needle near the sharpened tip.

21. The assembly of claim 20, wherein the radiopaque material has a thickness of at least 200 microinches.

22. The assembly of claim 12, wherein the polymer tube comprises a conical section at the polymer tube'"'"'s distal end prior to or after being reflowed around the overlap region.

23. The assembly of claim 12, wherein the needle has a length of approximately 5 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of approximately 2 centimeters.

24. The assembly of claim 13, wherein the superelastic alloy comprises Nitinol.

25. The assembly of claim 13, wherein the needle has a wall thickness of approximately 0.0015 inches thick.

26. The assembly of claim 13, further comprising:

a sharpened tip at the distal end of the needle; and

a radiopaque material positioned around the needle near the sharpened tip.

27. The assembly of claim 26, wherein the radiopaque material has a thickness of at least 200 microinches.

28. The assembly of claim 13, wherein the polymer tube comprises a conical section at the polymer tube'"'"'s distal end prior to or after being reflowed around the overlap region.

29. The assembly of claim 13, wherein the needle has a length of approximately 5 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of approximately 2 centimeters.