Minimally invasive tooling for delivery of interspinous spacer

• US 8,128,662 B2
• Filed: 10/18/2006
• Issued: 03/06/2012
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation), Vetiflex, Inc.
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Altarac, Moti, Tebbe, Shawn, Gutierrez, Robert, Kim, Daniel H., Flaherty, J. Christopher
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US11/582,874
• Publication Number:
  US 20070276370A1
• Time in Patent Office: 1,966 Days
• Field of Search: 623/17.11
• US Class Current: 606/249
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/025 Joint distractors
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/0077 : Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

A plurality of individual tools is provided where each tool is uniquely configured to perform a step or a portion of a step in a novel procedure associated with the implantation of a stabilizing device (e.g., an interspinous spacer) for stabilizing at least one spinal motion segment. The tools are usable individually, or more preferably as a tooling system in which the tools are collectively employed to implant an interspinous spacer, generally in a minimally invasive manner. For example, each of the tools is arranged with coordinated markings and/or other features to ensure consistent depths of insertion, proper orientation of the tools with respect to each other or an anatomical feature of the patient, and precise delivery of the spacer to maintain safe positioning throughout the implantation procedure.

Claims

1. A method for implanting an interspinous spacer having a longitudinal dimension in an interspinous space between adjacent spinous processes of a patient, the method comprising:

inserting a cannula having a working channel along a posterior, mid-line approach through the patient'"'"'s supraspinous ligament, wherein the cannula comprises a rigid elongated tube with a proximal end, a distal end, and a lumen therethrough;

placing a mounting bracket comprising a receiving tube and an attachment port over the cannula so that the cannula is received in the receiving tube;

attaching the attachment port to a stabilizing device;

orienting the cannula relative to the stabilizing device; and

delivering the interspinous spacer through the cannula with the longitudinal dimension of the interspinous spacer extending along the working channel of the cannula to the interspinous process space between the spinous processes.

2. The method of claim 1, further comprising penetrating the supraspinous ligament using a target needle, the target needle comprising a hollow needle comprising a proximal end, a distal end, and a lumen therethrough and an inner core slidably received by the hollow needle.

3. The method of claim 2, further comprising removing the inner core from the hollow needle after penetrating the supraspinous ligament.

4. The method of claim 1, further comprising oscillating the cannula in partial rotations in clockwise and counterclockwise direction to separate filamentous strands of the supraspinous ligament.

5. The method of claim 1, further comprising applying a distraction force between a first spinous process and a second spinous process using an interspinous gauge, the interspinous gauge comprising an elongated barrel with a proximal end and a distal end, and a handle attached to the proximal end of the elongated barrel.

6. The method of claim 1, further comprising creating an opening in the supraspinous ligament.

7. The method of claim 6 wherein creating an opening in the supraspinous ligament includes creating an opening using a first ligament separating tool and delivering energy to the distal end of the ligament separating tool to thereby cut tissue and/or coagulate blood.

8. The method of claim 6 wherein creating an opening in the supraspinous ligament includes creating an opening using a first ligament separating tool comprising an elongated tube with a proximal end, a distal end, and a lumen therebetween, and a ligament separating assembly disposed proximate to the distal end of the elongated tube.

9. A method of implanting an interspinous spacer in an interspinous space between adjacent interspinous processes of a patient, the method comprising:

providing an interspinous spacer having a longitudinal dimension in an undeployed configuration for implantation;

providing an insertion instrument having a longitudinal dimension;

operating the insertion instrument to thereby engage with the interspinous spacer such that the longitudinal dimension of the interspinous spacer extends in the same direction as the longitudinal dimension of the insertion instrument, the insertion instrument comprising a barrel assembly with a proximal end and a distal end, the barrel assembly comprising an elongated outer tube, an inner shaft slidably received by the outer tube, and a handle assembly fixedly attached to the proximal end of the barrel assembly;

inserting the interspinous spacer through the patient'"'"'s supraspinous ligament such that the longitudinal dimension of the interspinous spacer extends along a posterior-anterior axis of the interspinous space;

rotating a superior member and an inferior member both attached to one end of the body of the interspinous spacer from the undeployed position to a deployed position such that the superior member is positioned along lateral sides of a superior spinous process and the inferior member is positioned along lateral sides of an inferior spinous process by operation of the handle assembly; and

disengaging the insertion instrument from the interspinous spacer.

10. The method of claim 9 wherein operating the insertion instrument to thereby engage with the interspinous spacer comprises inserting the barrel assembly into the cannula until a mechanical feature mates with the cannula to thereby set a depth of insertion and/or an orientation of the insertion instrument.

11. The method of claim 9, further comprising reading a deployment status indicator to receive quantitative deployment information.

12. The method of claim 9, further comprising delivering energy to the distal end of the barrel to thereby cut tissue, coagulate blood and/or treat osteophytes.

13. The method of claim 9, further comprising measuring a distance between a first and a second spinous process using the insertion instrument configured with an interspinous gauge assembly.

14. The method of claim 9, further comprising measuring a force required to distract two spinous processes a fixed distance using the insertion instrument configured with a force measurement assembly.

15. The method of claim 9, further comprising measuring a thickness of one or more spinous processes using the insertion instrument configured with a thickness measurement assembly.

16. A method for implanting an interspinous spacer in an interspinous space between adjacent spinous processes, the method comprising:

inserting a cannula through the skin of the patient and through a supraspinous ligament of the patient to a location proximate to the patient'"'"'s spine, the cannula comprising a rigid elongated tube with a proximal end, a distal end, and a lumen therethrough; and

delivering an interspinous spacer through the cannula and into the interspinous space using one or more tools from a tool set comprising a plurality of individual tools, the individual tools selected from one of interspinous knife, ligament separating tool, interspinous reamer and interspinous gauge,

wherein the interspinous spacer has a body with a longitudinal dimension extending along a posterior-anterior axis within the interspinous space, and

wherein the interspinous knife comprises an elongated outer tube with a proximal end and a distal end;

an inner tube with a proximal end and a distal end, the inner tube slidably received by the elongated outer tube and the distal end of the inner tube including a cutting element having two blades substantially arranged in an X pattern, the interspinous knife further including a depth control element configured to allow an operator to select from a plurality of pre-set cutting depths, and

wherein the ligament separating tool comprises an elongated tube with a proximal end, a distal end, and a lumen therebetween, and a ligament separating assembly disposed proximate to the distal end of the elongated tube, and

wherein the interspinous reamer comprises an elongated tube with a proximal end and a distal end, the distal end comprising an axial cutting element configured to cut tissue of the patient, and a flat end drill, the drill configured to remove tissue from the elongated tube, and

wherein the interspinous gauge comprises an elongated barrel with a proximal end and a distal end, and at least one control attached to the proximal end of the elongated barrel wherein the interspinous gauge is configured to measure the distance between a first spinous process and a second spinous process of the patient through operation of the at least one control.

17. The method of claim 16 wherein inserting a cannula comprises inserting a cannula having a lumen diameter less than approximately 20 millimeters.

18. The method of claim 16 wherein the inserting is performed through the supraspinous ligament using a single insertion point that is substantially aligned with a midline of a supraspinous ligament.

19. The method of claim 16 wherein inserting a cannula comprises inserting a cannula having a lumen diameter less than approximately 15 millimeters.

20. The method of claim 16 wherein inserting a cannula comprises inserting a cannula having a lumen diameter of approximately 8 to 10 millimeters.

21. A method of implanting an interspinous spacer in an interspinous space located anterior of a supraspinous ligament and between superior and inferior spinous processes within a patient, comprising:

configuring an interspinous spacer in a low profile configuration, wherein the interspinous spacer has a longitudinal axis in the low profile configuration;

moving the interspinous spacer along an implant path in a posterior-to-anterior direction with the longitudinal axis extending along the implant path from an external position located posterior of the supraspinous ligament to an implant location located anterior of the supraspinous ligament, wherein the interspinous spacer enters the patient at a location at least proximate to a mid-line of the supraspinous ligament; and

expanding the interspinous spacer to an operative configuration when the interspinous spacer is at the implant location and while the longitudinal axis extends in a posterior-to-anterior direction along the implant path such that the interspinous spacer interfaces with the superior and inferior spinous processes.

22. The method of claim 21 wherein moving the interspinous spacer comprises passing the interspinous spacer through a lumen of a cannula from the external position to the implant location.

23. The method of claim 22 wherein the interspinous spacer passes through the supraspinous ligament.

24. The method of claim 22 wherein the interspinous spacer passes laterally adjacent the supraspinous ligament.

25. The method of claim 21, wherein the interspinous spacer comprises a body, a superior cam lobe rotatably coupled to the body, and an inferior cam lobe rotatably coupled to the body, and wherein expanding the interspinous spacer comprises rotating the superior cam lobe superiorly such that the superior cam lobe interfaces with the superior spinous process and rotating the inferior cam lobe inferiorly such that the inferior cam lobe interfaces with the inferior spinous process.

26. The method of claim 25 wherein moving the interspinous spacer comprises passing the interspinous spacer through a lumen of a cannula from the external position to the implant location.

27. The method of claim 26 wherein the interspinous spacer passes through the supraspinous ligament.

28. The method of claim 26 wherein the interspinous spacer passes laterally adjacent the supraspinous ligament.

29. A method of implanting an interspinous spacer in an interspinous space located anterior of a supraspinous ligament and between superior and inferior spinous processes within a patient, comprising:

configuring an interspinous spacer in a low profile configuration, wherein the interspinous spacer has a body with an anterior end and a posterior end spaced apart along an anterior-posterior axis, a superior cam lobe rotatably attached to the anterior end of the body, and an inferior cam lobe also rotatably attached to the anterior end of the body;

moving the interspinous spacer along an implant path in a posterior-to-anterior direction from an external position located posterior of the supraspinous ligament to an implant location located anterior of the supraspinous ligament, wherein the interspinous spacer enters the patient at a location at least proximate to a mid-line of the supraspinous ligament and the anterior-posterior axis of the body extends at least generally in the same direction as the implant path while moving the interspinous spacer along the implant path; and

rotating the superior and inferior cam lobes while the body is in the interspinous space such that the superior spinous process is received in the superior cam lobe and the inferior spinous process is received in the inferior cam lobe.

30. The method of claim 29 wherein moving the interspinous spacer comprises passing the interspinous spacer through a lumen of a cannula from the external position to the implant location.

31. The method of claim 30 wherein the interspinous spacer passes through the supraspinous ligament.

32. The method of claim 30 wherein the interspinous spacer passes laterally adjacent the supraspinous ligament.