Trackable biopsy needle

• US 9,750,486 B2
• Filed: 10/25/2011
• Issued: 09/05/2017
• Est. Priority Date: 10/25/2011
• Status: Active Grant

• Current Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Inventors: Burg, Bruce M., Hartmann, Steven L.
• Primary Examiner(s): SIRIPURAPU, RAJEEV P
• Application Number:
  US13/281,001
• Publication Number:
  US 20130102878A1
• Time in Patent Office: 2,142 Days
• Field of Search: 600411, 600424, 32420711
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/062 using magnetic field

Abstract

A trackable biopsy needle assembly including an inner tube of an outer cannula, an inner dielectric layer, a first coil, a second coil, a third coil, an outer dielectric layer, and an outer tube of the outer cannula. The inner tube defines a bore. The inner dielectric layer is secured onto an outer surface of the inner tube. The first, second, and third coils are wound over the inner dielectric layer. The outer dielectric layer is secured onto the first coil, the second coil, and the third coil. The outer tube is fastened to the outer dielectric layer.

Claims

1. A trackable biopsy needle assembly comprising:

an inner tube of an outer cannula defining a bore and a first inner diameter configured to slidably receive an inner cannula therein, the inner tube including a first inner surface that is smooth along its length to slidably mate with a first outer surface of the inner cannula that is smooth along its length;

an inner dielectric layer secured onto an outer surface of the inner tube;

a first coil, a second coil, and a third coil wound over the inner dielectric layer;

an outer dielectric layer secured onto the first coil, the second coil, and the third coil; and

an outer tube of the outer cannula fastened to the outer dielectric, the outer tube defining a first outer diameter at a second outer surface thereof that is smooth along its length, the first coil, the second coil, and the third coil are between the inner tube of the outer cannula and the outer tube of the outer cannula;

wherein the inner tube and the outer tube are fixed to one another and each one of the first coil, the second coil, and the third coil are adhesively embedded between the inner tube and the outer tube.

2. The biopsy needle assembly of claim 1, wherein the inner tube and the outer tube are formed of steel.

3. The biopsy needle assembly of claim 1, wherein the inner dielectric and the outer dielectric are each secured with a heat shrink;

and

wherein the outer tube of the outer cannula is fastened to the outer dielectric layer with an adhesive.

4. The biopsy needle assembly of claim 1, wherein each of the first coil, the second coil, and the third coil are wound into a first layer and a second layer.

5. The biopsy needle assembly of claim 4, wherein each first layer and each second layer include 340 coil winds.

6. The biopsy needle assembly of claim 1, wherein the first coil, the second coil, and the third coil are each wound at an angle of 55°

relative to a longitudinal axis of the outer cannula.

7. The biopsy needle assembly of claim 6, wherein the first coil, the second coil, and the third coil are each rotated at 120°

relative to one another about the longitudinal axis.

8. The biopsy needle assembly of claim 1, wherein the first coil, the second coil, and the third coil are spaced 13.5 millimeters apart as measured between center points of each of the first coil, the second coil, and the third coil.

9. The biopsy needle assembly of claim 1, wherein the third coil is spaced apart 5.0 millimeters from a distal end of the inner tube.

10. The biopsy needle assembly of claim 1, further comprising a tip defining an outer biopsy window, the tip fastened to a distal end of at least one of the inner tube and the outer tube, the tip defining a second inner diameter that is the same as the first inner diameter and a second outer diameter that is the same as the first outer diameter.

11. The biopsy needle assembly of claim 1, further comprising a tip defining an outer biopsy window, a second inner diameter that is the same as the first inner diameter, and a second outer diameter that is the same as the first outer diameter;

wherein a proximal end of the tip is secured between the outer tube and the inner tube.

12. The biopsy needle assembly of claim 11, wherein the tip is secured with an over mold.

13. The biopsy needle assembly of claim 1, further comprising:

a first flexible circuit between the first coil and a proximal end of the inner tube, the first coil is connected to the first flexible circuit with a first coil lead, the first circuit is configured to be connected to a coil array controller of an electromagnetic tracking system with a first cable lead;

a second flexible circuit between the first coil and the second coil, the second coil is connected to the second flexible circuit with a second coil lead, the second circuit is configured to be connected to the coil array controller with a second cable lead; and

a third flexible circuit between the second coil and the third coil, the third coil is connected to the third flexible circuit with a third coil lead, the third circuit is configured to be connected to the coil array controller with a third cable lead.

14. The biopsy needle assembly of claim 10, further comprising the inner cannula defining an inner biopsy window and configured to be received within the bore defined by the inner tube such that the inner biopsy window is aligned with the outer biopsy needle.

15. A trackable biopsy needle assembly comprising:

an outer cannula including;

an outer cannula hub;

an outer tube extending from the outer cannula hub and defining a first outer diameter, the outer tube is smooth along its entire length at the first outer diameter;

an inner tube affixed to the outer tube, the inner tube defining a bore and a first inner diameter, the inner tube is smooth along its entire length at the first inner diameter; and

a plurality of conductive coils between the inner tube and the outer tube for tracking a position of the biopsy needle assembly within a magnetic field;

a tip extending from a distal end of the outer cannula, the tip defining an outer biopsy window, a tip cavity aligned with the bore, a second outer diameter that is the same as the first outer diameter, and a second inner diameter that is the same as the first inner diameter; and

an inner cannula including;

an inner cannula hub;

an inner cannula shaft extending from the inner cannula hub, the inner cannula defining a third outer diameter, the inner cannula shaft is smooth along its entire length at the third outer diameter and configured to slidably mate with the inner tube at the first inner diameter thereof; and

an inner biopsy window defined by the inner cannula shaft proximate to an inner cannula shaft tip;

wherein the inner cannula shaft is sized to be received by the bore of the outer cannula and the tip cavity of the tip such that the inner biopsy window aligns with the outer biopsy window, the inner cannula is movable relative to the outer cannula.

16. The biopsy needle assembly of claim 15, wherein the plurality of conductive coils include a first coil, a second coil, and a third coil each connected to a first flexible circuit, a second flexible circuit, and a third flexible circuit respectively;

and

wherein each of the first coil, the second coil, and the third coil are wound into a first layer including 340 coil winds and a second layer including 340 coil winds.

17. The biopsy needle assembly of claim 16, wherein the first coil, the second coil, and the third coil are each wound at 55°

relative to a longitudinal axis of the outer cannula;

wherein the third coil is spaced apart 5.0 millimeters from a distal end of the inner tube; and

wherein the first coil, the second coil, and the third coil are spaced 13.5 millimeters apart as measured between center points of each of the first coil, the second coil, and the third coil.

18. A system for tracking a position of a trackable biopsy needle in a patient space comprising:

an outer cannula of the biopsy needle including a first coil, a second coil, and a third coil, each of which are adhesively embedded between fixed inner and outer tubes of the outer cannula and angled relative to a longitudinal axis of the outer cannula, the inner tube has a smooth inner surface along its entire length defining a constant inner diameter that defines a bore therethrough, the outer tube has a smooth outer surface along its entire length defining a constant first outer diameter;

an inner cannula configured to be slidably received within the inner tube of the outer cannula, the inner cannula has a second smooth outer surface along its entire length defining a constant second outer diameter, the second smooth outer surface configured to slidably mate with the smooth inner surface of the inner tube;

a first flexible circuit between the first coil and a proximal end of the inner tube, the first coil is connected to the first flexible circuit with a first coil lead, the first circuit is configured to be connected to a coil array controller of an electromagnetic tracking system with a first cable lead;

a second flexible circuit between the first coil and the second coil, the second coil is connected to the second flexible circuit with a second coil lead, the second circuit is configured to be connected to the coil array controller with a second cable lead;

a third flexible circuit between the second coil and the third coil, the third coil is connected to the third flexible circuit with a third coil lead, the third circuit is configured to be connected to the coil array controller with a third cable lead;

the electromagnetic tracking system including a localizer to generate an electromagnetic field for use in navigating the biopsy needle;

an imaging system that images a patient to provide image data; and

a navigation controller for receiving tracking information from the electromagnetic tracking system and the image data from the imaging system, where the navigation controller is configured to identify the position of the biopsy needle on the image data.

19. The system of claim 18, wherein the first coil, the second coil, and the third coil are connected to the localizer with individual cable leads.

20. The system of claim 18, wherein the first coil, the second coil, and the third coil are each wound into a first layer including 340 coil winds and a second layer including 340 coil winds;

wherein the first coil, the second coil, and the third coil are each wound at 55°

relative to the longitudinal axis of the outer cannula;

wherein the first coil, the second coil, and the third coil are each rotated at 120°

relative to each other about the longitudinal axis; and

wherein the third coil is spaced apart about 5.0 millimeters from a distal end of the outer cannula.