Insulated pedicle access system and related methods

• US 9,750,508 B1
• Filed: 11/12/2010
• Issued: 09/05/2017
• Est. Priority Date: 11/11/2009
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Barnes, Jeff, Finley, Eric, Scholl, Thomas
• Primary Examiner(s): Bates, David
• Application Number:
  US12/945,705
• Time in Patent Office: 2,489 Days
• Field of Search: 606 86 R, 606 96, 606102-104, 606 86 A, 606 32, 606 41, 606 43, 606 44, 606185, 60416401, 607115, 607117
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/7092 for checking pedicle hole has correct depth or has an intact wall pedicle drill depth limiters A61B17/1626

Abstract

The present invention relates to devices and methods directed towards accessing and forming holes in bone tissue including penetrating vertebral bones during surgical treatments of the spine, for example, to cannulate pedicles and form pilot holes for placing pedicle screws.

Claims

1. A needle assembly system for use in a medical procedure, comprising:

a cannula assembly including concentric inner and outer cannulas wherein the inner cannula has a distal end and a first length and the outer cannula has a distal end and a second length shorter than the first length, an insulated sheath situated between the inner cannula and the outer cannula, and a spring situated proximal to the insulated sheath and between the inner cannula and outer cannula, said insulated sheath spring biased to a first position in which a distal end of the insulated sheath is proximate the distal end of the inner cannula and movable between a position in which a distal end of the insulated sheath is proximate the distal end of the inner cannula and closer to the distal end of the inner cannula than to the distal end of the outer cannula, and a position in which a distal end of the insulated sheath is proximate the distal end of the outer cannula and closer to the distal end of the outer cannula than to the distal end of the inner cannula; and

a stylet disposed through the inner cannula and having a shaped tip that protrudes from the distal end of the inner cannula.

2. The system of claim 1, wherein the outer cannula is also insulated.

3. The system of claim 1, wherein a connector situated outside the outer cannula is attached to the insulated sheath.

4. The system of claim 3, wherein the connector attaches to the insulated sheath through at least one elongated slot proximate a distal end of the outer cannula.

5. The system of claim 3, wherein the outer cannula includes graduated depth markers and the position of the connector relative to the depth marker provides an indication of penetration depth of the shaped tip of the stylet into tissue.

6. The system of claim 1, further including a handle comprising an upper portion and a lower portion separable from the upper portion.

7. The system of claim 6, wherein the upper portion is connected to the stylet and the lower portion is connected to the cannula assembly and the upper and lower portions are lockable to one another to lock the cannula assembly and the stylet together.

8. The system of claim 7, further including a contact that receives electrical stimulation signals from a stimulator via a stimulation clip associated with the stimulator.

9. The system of claim 8, wherein said contact is a conductive surface situated within the upper handle portion attached to the stylet.

10. The system of claim 9, wherein the upper portion of the handle includes a cutout region that securely engages the stimulation clip.

11. The system of claim 1, wherein the stylet is removable from the cannula assembly.

12. The system of claim 11, further including a k-wire advanceable through the inner cannula after the stylet has been removed.

13. The system of claim 1, wherein the shaped tip and the distal end of the inner cannula are adapted to form a hole in bone and a distal end of the insulated sheath is adapted to engage a surface of the bone when the shaped tip and the distal end of the inner cannula are advanced into bone such that the insulated sheath slides relative to the inner cannula and outer cannula as the shaped tip and distal end of the inner cannula are advanced deeper into the bone exposing the exterior of inner cannula to the interior of the bone.

14. A needle assembly system for use in a medical procedure, comprising:

a cannula assembly including concentric inner and outer cannulas wherein the inner cannula has a distal end and a first length and the outer cannula has a distal end and a second length shorter than the first length, and an insulated sheath situated between the inner cannula and the outer cannula and movable between a position in which a distal end of the insulated sheath is proximate the distal end of the inner cannula and closer to the distal end of the inner cannula than to the distal end of the outer cannula, and a position in which a distal end of the insulated sheath is proximate the distal end of the outer cannula and closer to the distal end of the outer cannula than to the distal end of the inner cannula, wherein the insulated sheath is spring biased towards the position proximate the distal end of the inner cannula by a spring positioned between the inner and outer cannulae,

a stylet disposed through the inner cannula and having a shaped tip that protrudes from the distal end of the inner cannula, and

a connector situated outside the outer cannula and concentric with the outer cannula and attached to the insulated sheath through at least one elongated slot wherein the connector is moveable axially along the outer surface of the outer cannula.

15. The system of claim 14, wherein the outer cannula is also insulated.

16. The system of claim 14, wherein the outer cannula includes graduated depth markers and the position of the connector relative to the depth marker provides an indication of penetration depth of the shaped tip of the stylet into tissue.

17. The system of claim 14, further including a handle comprising an upper portion connected to the stylet, a lower portion connected to the cannula assembly, wherein the lower portion is separable from the upper portion and the upper and lower portions are lockable to one another to lock the cannula assembly and the stylet together.

18. The system of claim 14, further including a contact that receives electrical stimulation signals from a stimulator via a stimulation clip associated with the stimulator.

19. The system of claim 18, wherein said contact is a conductive surface situated within the upper handle portion attached to the stylet.

20. The system of claim 18, wherein the upper portion of the handle includes a cutout region that securely engages the stimulation clip.

21. A needle assembly system for use in a medical procedure, comprising:

a cannula assembly including concentric inner and outer cannulas wherein the inner cannula has a distal end and a first length and the outer cannula has a distal end and a second length shorter than the first length, and an insulated sheath situated between the inner cannula and the outer cannula and movable between a position in which a distal end of the insulated sheath is proximate the distal end of the inner cannula and closer to the distal end of the inner cannula than to the distal end of the outer cannula, and a position in which a distal end of the insulated sheath is proximate the distal end of the outer cannula and closer to the distal end of the outer cannula than to the distal end of the inner cannula, wherein the insulated sheath is spring biased towards the position proximate the distal end of the inner cannula by a spring positioned between the inner and outer cannulae;

a stylet disposed through the inner cannula and having a shaped tip that protrudes from the distal end of the inner cannula; and

a handle comprising an upper portion and a lower portion, which is separable from the upper portion, wherein the upper portion is connected to the stylet and the lower portion is connected to the cannula assembly, said upper and lower portion lockable to one another to lock the cannula assembly and stylet together, said handle further including a contact that is configured to receive electrical stimulation signals from a stimulator.

22. The system of claim 21, wherein said contact is a conductive surface situated within the upper handle portion attached to the stylet.

23. The system of claim 22, wherein the upper portion of the handle includes a cutout region that securely engages the stimulation clip.