Minimally invasive tooling for delivery of interspinous spacer

• US 9,155,572 B2
• Filed: 03/06/2012
• Issued: 10/13/2015
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Altarac, Moti, Guiterrez, Robert, Tebbe, Shawn, Kim, Daniel H., Flaherty, J. Christopher
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US13/413,550
• Publication Number:
  US 20120226315A1
• Time in Patent Office: 1,316 Days
• Field of Search: 606246-249, 623 1711- 1716
• US Class Current: 1/1
• 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 of implanting an interspinous spacer into an interspinous space between a superior spinous process and an inferior spinous process of a patient, the method comprising:

positioning an interspinous spacer in an undeployed configuration at an external posterior location relative to the interspinous space, wherein a superior spinous process stabilizer and an inferior spinous process stabilizer of the interspinous spacer are in a collapsed position in the undeployed configuration;

while in the undeployed configuration, moving the interspinous spacer in a substantially anterior-posterior direction through a supraspinous ligament of the patient and along an insertion path oriented in the substantially anterior-posterior direction toward the interspinous space, wherein the interspinous spacer has a longitudinal dimension capable of remaining aligned with the insertion path while moving the interspinous spacer through the supraspinous ligament; and

while the interspinous spacer is located at the interspinous space and a body of the interspinous spacer is located directly between the superior spinous process and the inferior spinous process, moving the superior and inferior spinous process stabilizers from the undeployed configuration to a deployed configuration such that the superior and inferior spinous process stabilizers of the interspinous spacer interface with the superior and inferior spinous processes.

2. The method of claim 1 wherein moving the superior and inferior spinous process stabilizers comprises extending the superior and inferior spinous process stabilizers while the longitudinal dimension of the interspinous spacer is aligned with the insertion path.

3. The method of claim 1 wherein moving the interspinous spacer through the supraspinous ligament comprises moving the interspinous spacer through a midline portion of the supraspinous ligament.

4. The method of claim 1 wherein:

positioning the interspinous spacer comprises engaging the interspinous spacer to a distal end portion of an insertion instrument;

moving the superior and inferior spinous process stabilizers comprises extending the superior and inferior spinous process stabilizers in response to movement of the insertion instrument, and

the method further comprises disengaging the interspinous spacer from the distal end portion of the insertion instrument.

5. The method of claim 1 wherein moving the interspinous spacer through the supraspinous ligament comprises passing the interspinous spacer through a lumen of a cannula.

6. The method of claim 5 wherein passing the interspinous spacer through the lumen of the cannula comprises passing the interspinous spacer through the lumen with the longitudinal dimension aligned with a longitudinal axis of the cannula.

7. The method of claim 1 wherein the interspinous spacer comprises a superior feature movably coupled to the body and an inferior feature movably coupled to the body, and wherein moving the superior and inferior spinous process stabilizers comprises moving the superior feature superiorly such that the superior spinous process stabilizer interfaces with the superior spinous process and moving the inferior feature inferiorly such that the inferior spinous process stabilizer interfaces with the inferior spinous process.

8. The method of claim 1 wherein moving the superior and inferior spinous process stabilizers from the undeployed configuration to the deployed configuration includes

rotating the superior spinous process stabilizer relative to the body of the interspinous spacer such that the superior spinous process is located between spaced apart arms of the superior spinous process stabilizer;

and

rotating the inferior spinous process stabilizer relative to the body of the interspinous spacer such that the inferior spinous process is located between spaced apart arms of the inferior spinous process stabilizer.

9. A method of positioning an interspinous spacer, the method comprising:

positioning a distal end portion of a cannula proximate to an interspinous space between a superior spinous process and an inferior spinous process, the cannula having a longitudinal axis extending in a substantially posterior-anterior direction;

delivering an interspinous spacer to the interspinous space by moving the interspinous spacer in the substantially posterior-anterior direction through the cannula with a longitudinal dimension of the interspinous spacer parallel to the longitudinal axis of the cannula; and

deploying the interspinous spacer from a low profile configuration to an operative configuration while the interspinous spacer is at the interspinous space.

10. The method of claim 9 wherein deploying the interspinous spacer comprises deploying the interspinous spacer while the longitudinal dimension of the interspinous spacer is parallel to the longitudinal axis of the cannula.

11. The method of claim 9, further comprising coupling the interspinous spacer to a distal end portion of a delivery device, and wherein delivering the interspinous spacer comprises passing the interspinous spacer through the cannula with the distal end portion of the delivery device.

12. The method of claim 11 wherein the delivery device comprises an inner shaft extending through a barrel, and wherein deploying the interspinous spacer comprises moving the inner shaft relative to the barrel.

13. The method of claim 11, further comprising disengaging the interspinous spacer from the delivery device and removing the delivery device from the cannula.

14. The method of claim 9 wherein positioning the distal end portion of the cannula comprises passing the distal end portion of the cannula through a supraspinous ligament of a patient.

15. The method of claim 9 wherein positioning the distal end portion of the cannula comprises passing the distal end portion of the cannula laterally adjacent to a supraspinous ligament of a patient.

16. A method comprising:

positioning a distal end portion of a cannula proximate to an interspinous space between a superior spinous process and an inferior spinous process of a subject such that the cannula extends in a substantially anterior-to-posterior direction relative to the subject;

delivering an interspinous spacer to the interspinous space by moving the interspinous spacer in the substantially anterior-to-posterior direction through the cannula; and

deploying the interspinous spacer from a low profile configuration to an operative configuration while a body of the interspinous spacer is positioned directly between the superior spinous process and the inferior spinous process.

17. The method of claim 16 wherein deploying the interspinous spacer comprises moving a superior spinous process stabilizer of the interspinous spacer and an inferior spinous process stabilizer of the interspinous spacer such that the superior and inferior spinous process stabilizers contact the superior and inferior spinous processes, respectively.

18. The method of claim 16 wherein deploying the interspinous spacer comprises moving one or more spinous process stabilizers of the interspinous spacer while a longitudinal dimension of the interspinous spacer is aligned with a longitudinal axis of the cannula.

19. The method of claim 16, further comprising holding the interspinous spacer spaced apart from and posterior to an intervertebral disk adjacent to the interspinous space while deploying the interspinous spacer from the low profile configuration to the operative configuration.

20. The method of claim 16 wherein deploying the interspinous spacer includes deploying superior and inferior process stabilizers of the interspinous spacer such that the superior and inferior process stabilizers receive the superior and inferior spinous processes, respectively, while a longitudinal axis of the interspinous spacer extends in a substantially anterior-to-posterior direction relative to the subject'"'"'s spine.

21. A method of positioning an interspinous spacer at an interspinous space between a superior spinous process and an inferior spinous process of a subject, the method comprising:

positioning a cannula in the subject, wherein the cannula is configured to extend in a substantially anterior-to-posterior direction relative to the subject'"'"'s spine;

delivering the interspinous spacer to the interspinous space by moving the interspinous spacer through the cannula and in the substantially anterior-to-posterior direction; and

moving the interspinous spacer toward a deployed configuration while a longitudinal axis of a body of the interspinous spacer extends in the substantially anterior-to-posterior direction and the body of the interspinous spacer is positioned at the interspinous space.

22. The method of claim 21 wherein moving the interspinous spacer toward the deployed configuration includes moving superior and inferior spinous process stabilizers of the interspinous spacer from an undeployed position to a deployed position, and wherein the superior and inferior spinous process stabilizers in the deployed position are configured to hold the superior and inferior spinous processes.

23. The method of claim 22 wherein moving the superior and inferior spinous process stabilizers includes

rotating the superior spinous process stabilizer relative to the body of the interspinous spacer such that the superior spinous process is located between spaced apart arms of the superior spinous process stabilizer;

and

rotating the inferior spinous process stabilizer relative to the body of the interspinous spacer such that the inferior spinous process is located between spaced apart arms of the inferior spinous process stabilizer.