System and method for stabilizing implanted spinal cord stimulators

• US 9,186,497 B2
• Filed: 09/18/2014
• Issued: 11/17/2015
• Est. Priority Date: 03/31/2014
• Status: Active Grant

• Current Assignee: K-D Instruments, Inc.
• Original Assignee: K-D Instruments, Inc.
• Inventors: Hamilton, Dennison
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US14/490,069
• Publication Number:
  US 20150273209A1
• Time in Patent Office: 425 Days
• Field of Search: 607/43, 607/117, 606/80, 606/129
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1622 Drill handpieces A61B17/1626, A61B17/1628 take precedence
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2017/3458 threaded
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A system and method for implanting and stabilizing spinal cord stimulators in an epidural space of the spinal column of a patient to prevent or limit axial movement of the stimulators once implanted in the epidural space. The system includes a drill assembly, a guide wire assembly, and a guide wire receiver. The drill assembly includes a cannula, a drill for creating access points in the patient'"'"'s spinal column for implanting the stimulators, and an incremental drill adjuster for drilling into the patient'"'"'s lamina a pre-set, discrete distance. The guide wire assembly includes a hollowed guide wire sleeve, a guide wire housed within the sleeve, and a magnet disposed on a proximal end of the guide wire assembly. The guide wire receiver includes a scoop for receiving and catching the magnet to assist in feeding the stimulators through the epidural space.

Claims

1. A system for stabilizing electrical stimulators implanted within the epidural space of a patient'"'"'s spinal column, the stimulators comprising at least one lead and a lead wire connected to said at least one lead, said system comprising:

a drill assembly including

a cannula having a handle and a hollowed cannula shaft coupled to and extending from the handle, wherein the hollowed cannula shaft presents a cannula lumen,

a drill having a drill handle and a hollowed drill shaft presenting a drill lumen,

wherein the drill shaft has proximal and distal ends,

wherein a drill bit is provided on the proximal end of the shaft,

wherein the drill shaft is configured to be inserted in the cannula lumen, and

an incremental drill adjuster at least partially mounted within the handle of the cannula and configured to advance the drill shaft by a pre-set distance;

a guide wire assembly having proximal and distal ends and including a hollowed guide wire sleeve presenting a guide wire sleeve lumen and a guide wire housed within the guide wire sleeve lumen,

wherein a magnet is provided on the proximal end of the guide wire assembly; and

a guide wire receiver comprising a handle and an elongated shaft,

wherein the guide wire receiver is a physically separated component from the guide wire assembly and is moveable relative to the guide wire assembly,

wherein the shaft of the guide wire receiver has a handle end coupled to the handle and a receiving end opposite the handle end,

wherein the shaft is semi-cylindrical along a portion of its length to present an open lumen,

wherein at least a portion of the open lumen at said receiving end of the shaft is widened to provide a scoop for receipt of the magnet on the proximal end of the guide wire assembly to transfer the guide wire through the guide wire sleeve, to the guide wire receiver, and through the at least a portion of a length of the open lumen of the guide wire receiver.

2. The system of claim 1, the drill assembly further including a drill stylet having a drill stylet handle and a drill stylet shaft,

wherein the drill stylet shaft is configured to be fed through the drill lumen,

wherein the drill stylet handle includes left and right side walls.

3. The system of claim 2,

wherein the drill handle has a cutout formed in the handle for receipt of a portion of the drill stylet handle,

wherein the cutout includes a seat and left and right side walls extending distally from the seat,

wherein the cutout further includes a notch extending proximally from the seat,

wherein a bottom of the drill stylet handle is complementally shaped to be received within the cutout and seated against the seat,

wherein the left and right side walls of the cutout in the drill handle are complementally shaped to fit and receive the left and right side walls of the drill stylet handle,

wherein the drill stylet handle is rotatable approximately 90 degrees about a stylet shaft axis,

wherein upon rotation of approximately 90 degrees of the drill stylet handle, a bottom of the drill stylet handle is sized and configured to be received within the notch of the drill handle, such that a length of the drill stylet shaft is external to a proximal-most end of the drill shaft.

4. The system of claim 1, wherein the incremental drill adjuster includes the following:

a spring-loaded ball detent having a spring and a ball positioned proximate the spring and operable to act against the spring to retract the spring,

wherein the spring and ball are located in the cannula handle, and

a plurality of adjacent detents formed on the distal end of the drill shaft,

wherein a portion of the ball is configured to rest in one of the plurality of adjacent detents.

5. The system of claim 1, further including a monofilament configured to be fed through the guide wire sleeve lumen from one of the lumbar or thoracic regions of the patient and to an other of the lumbar or thoracic regions of the patient.

6. The system of claim 5, further including a tubular connector for coupling one end of the monofilament to one end of the connector, and for coupling an end of the lead wire to an other end of the connector.

7. The system of claim 6, wherein the connector is a cylindrical portion of carbothane tubing.

8. A system for stabilizing electrical stimulators implanted within the epidural space of a patient'"'"'s spinal column, the stimulators comprising at least one lead and a lead wire connected to said at least one lead, said system comprising:

a drill assembly including—

a drill having a drill handle and a drill shaft, and an incremental drill adjuster configured to advance the drill shaft by a pre-set distance;

a guide wire assembly having proximal and distal ends and including a hollowed guide wire sleeve presenting a guide wire sleeve lumen and a guide wire housed within the guide wire sleeve lumen, wherein a magnet is provided on the proximal end of the guide wire assembly; and

a guide wire receiver having proximal and distal ends and including a handle at the distal end, an elongated hollowed shaft extending from the handle, and a scoop at the proximal end, wherein the proximal end of the guide wire receiver having the scoop is configured to be positioned proximate the proximal end of the guide wire assembly having the magnet, such that the scoop is configured to receive the magnet to transfer the guide wire through the guide wire sleeve, to the guide wire receiver, and through at least a portion of a length of the shaft of the guide wire receiver.

9. The system of claim 8, wherein the scoop is flexible and configured to be rolled from an unfolded condition to a folded condition.

10. The system of claim 8, wherein the scoop has a distal end, a proximal end, and sidewalls disposed therebetween.

11. The system of claim 10, wherein the sidewalls of the scoop are angled outwards as a proximal-most end of the scoop is approached.

12. The system of claim 11, wherein the proximal-most end of the scoop is wider than the elongated shaft of the guide wire receiver.

13. The system of claim 8, the drill assembly further including:

a cannula having a handle and a hollowed cannula shaft, and

a drill stylet having a drill stylet handle and a drill stylet shaft,

wherein the drill shaft presents a drill lumen,

wherein the drill stylet shaft is configured to be fed through the drill lumen,

wherein the drill stylet handle includes left and right side walls.

14. The system of claim 13,

wherein the drill handle has a cutout formed in the handle for receipt of a portion of the drill stylet handle,

wherein the cutout includes a seat and left and right side walls extending distally from the seat,

wherein the cutout further includes a notch extending proximally from the seat,

wherein a bottom of the drill stylet handle is complementally shaped to be received within the cutout and seated against the seat,

wherein the left and right side walls of the cutout in the drill handle are complementally shaped to fit and receive the left and right side walls of the drill stylet handle,

wherein the drill stylet handle is rotatable approximately 90 degrees about a stylet shaft axis,

wherein upon rotation of approximately 90 degrees of the drill stylet handle, a bottom of the drill stylet handle is sized and configured to be received within the notch of the drill handle, such that a length of the drill stylet shaft is external to a proximal-most end of the drill shaft.

15. The system of claim 14, wherein the incremental drill adjuster includes the following:

a spring-loaded ball detent having a spring and a ball positioned proximate the spring and operable to act against the spring to retract the spring,

wherein the spring and ball are located in the cannula handle, and

a plurality of adjacent detents formed on the distal end of the drill shaft,

wherein a portion of the ball is configured to rest in one of the plurality of adjacent detents.

16. The system of claim 8, further including a monofilament configured to be fed through the guide wire sleeve lumen from one of the lumbar or thoracic regions of the patient and to an other of the lumbar or thoracic regions of the patient.

17. The system of claim 16, further including a tubular connector for coupling one end of the monofilament to one end of the connector, and for coupling an end of the lead wire to an other end of the connector.

18. The system of claim 17, wherein the connector is a cylindrical portion of carbothane tubing.