LUNG BIOPSY NEEDLE

• US 20130225997A1
• Filed: 02/26/2013
• Published: 08/29/2013
• Est. Priority Date: 02/28/2012
• Status: Abandoned Application

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Dillard, David H., Gonzalez, Hugo X., Hoffman, Peter, O'Connell, Desmond
• Application Number:
  US13/778,049
• Publication Number:
  US 20130225997A1
• Time in Patent Office: Days
• US Class Current: 600/439
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: Y10T 29/49609 Spring making

Abstract

Systems, methods, and devices for biopsying tissue, in particular lung nodules, with a flexible needle are described herein. Preferably, the flexible needle is able to articulate or bend so as to provide access to areas previously difficult or impossible to biopsy. Further embodiments provide for steering and navigating the flexible needle to a region to be biopsied.

Claims

1. A flexible needle configured to access a location near an airway, the flexible needle having a length and comprising:

a proximal end;

a distal end comprising a piercing tip;

a flexible proximal tip region located along the length of the flexible needle between the distal end and the proximal end, the flexible proximal tip region having one or more flexibility increasing features and configured to bend; and

a flexible distal tip region located along the length of the flexible needle between the flexible proximal tip region and the distal end, wherein the flexible distal tip region is less flexible than the proximal tip region.

2. The flexible needle of claim 1, wherein the flexibility increasing feature comprises one or more cuts in the flexible needle.

3. The flexible needle of claim 2, wherein the one or more cuts extend in a spiral fashion along flexible proximal tip region.

4. The flexible needle of claim 2, wherein the one or more cuts are arranged in a jigsaw configuration.

5. The flexible needle of claim 2, wherein the one or more cuts are arranged in a serpentine configuration.

6. The flexible needle of claim 2, wherein the one or more cuts are arranged in an interrupted spiral pattern where the flexible needle has cut and uncut portions along a same spiral path.

7. The flexible needle of claim 2, wherein the one or more cuts are distributed asymmetrically on a portion of the length of flexible needle such that the cuts are located on only a portion of a radial circumference of the flexible needle.

8. A system for accessing tissue near an airway, the system comprising:

the flexible needle of claim 1;

a catheter comprising at least one interior lumen, the flexible needle being slidably received within the at least one interior lumen; and

a suction source in fluid communication with the flexible needle.

9. The system of claim 8, further comprising a steering mechanism configured to steer the flexible needle toward the tissue sample site.

10. The system of claim 9, wherein the steering mechanism comprises at least one guidewire extending longitudinally along the exterior of the flexible needle or the at least one interior lumen.

11. The system of claim 9, wherein the steering mechanism comprises a guidewire extending within an interior lumen of the flexible needle.

12. The system of claim 11, wherein the guidewire is removable from the interior lumen of the flexible needle.

13. The system of claim 8, further comprising a navigation system.

14. The system of claim 13, wherein the navigation system is an ultrasound probe.

15. The system of claim 14, wherein the ultrasound probe is located at a distal end of the catheter.

16. The system of claim 14, wherein the catheter comprises a second lumen and the ultrasound probe is received within the second lumen.

17. The system of claim 8, wherein the catheter is received within the working channel of a bronchoscope.

18. The system of claim 9, wherein the catheter is received within a bronchoscope comprising a second steering mechanism, and wherein the second steering mechanism can steer independently of the steering mechanism configured to steer the flexible needle.

19. A method of manufacturing a flexible needle comprising:

providing a tube shaped length of resilient material having a distal end and a proximal end;

forming an angled tip on the distal end of the tube shaped length of resilient material;

forming one or more flexibility increasing features on the tube shaped length of resilient material, such that the flexible needle comprises;

a flexible proximal tip region located along the tube shaped length of resilient material between the distal end and the proximal end, the flexible proximal tip region having one or more flexibility increasing features and configured to bend; and

a flexible distal tip region located along the tube shaped length of resilient material between the flexible proximal tip region and the distal end, wherein the flexible distal tip region is less flexible than the proximal tip region.

20. The method of claim 19, wherein forming the one or more flexibility increasing features includes cutting one or more cuts into a wall of the tube shaped length of resilient material.

21. The method of claim 20, wherein cutting the one or more cuts includes water jetting the wall of the tube shaped length of resilient material.

22. The method of claim 20, wherein cutting the one or more cuts includes laser cutting the wall of the tube shaped length of resilient material.

23. The method of claim 20, wherein cutting the one or more cuts includes chemical etching the wall of the tube shaped length of resilient material.

24. A method for obtaining a tissue sample near an airway, the method comprising:

identifying a location in the airway in close proximity to a tissue sample site;

introducing a flexible needle into the airway;

navigating the flexible needle to the location in the airway;

articulating the flexible needle in a direction toward the tissue sample site; and

obtaining a tissue sample from the tissue sample site, wherein the flexible needle pierces the airway and into the tissue sample site, and wherein suction is applied to the flexible needle so as to collect tissue from the tissue sample site.

25. The method of claim 24, wherein the flexible needle is articulated by a steering mechanism.

26. The method of claim 24, wherein the flexible needle is inserted into a lumen of a catheter.

27. The method of claim 26, wherein the step of navigating comprises locating the flexible needle with a radioopaque marker situated on the flexible needle and/or the catheter.

28. The method of claim 24, wherein the flexible needle is inserted into a lumen of a bronchoscope.