Methods for treating a patient's spine

• US 10,080,587 B2
• Filed: 10/09/2015
• Issued: 09/25/2018
• 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, Gutierrez, Robert, Tebbe, Shawn, Kim, Daniel H., Flaherty, J. Christopher
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US14/879,901
• Publication Number:
  US 20160135853A1
• Time in Patent Office: 1,082 Days
• 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 treating a subject, comprising:

moving at least one dilator through an opening in the subject'"'"'s supraspinous ligament;

moving a cannula through the opening;

moving an implantable device through the cannula toward an interspinous space between adjacent vertebrae while the cannula extends through the opening in the supraspinous ligament; and

deploying the implantable device to distract and/or space apart the adjacent vertebrae, wherein the adjacent vertebrae include a first vertebra and a second vertebra, and wherein deploying the implantable device includes

rotating a first cam lobe of the implantable device to position a first spinous process of the first vertebra between arms of the first cam lobe, and

rotating a second cam lobe of the implantable device to position a second spinous of the second vertebra process between arms of the second cam lobe.

2. The method of claim 1, further comprising:

distracting the first and second spinous processes by moving a tapered end portion of the cannula along the first and second spinous processes; and

delivering one or more instruments through the cannula to remove bone and/or soft tissue prior to deploying the implantable device.

3. The method of claim 1 wherein moving the at least one dilator through the opening includes:

moving a first dilator to dilate the opening; and

moving a second dilator along the first dilator to further dilate the opening.

4. The method of claim 1, further comprising removing bone and/or soft tissue using an interspinous reamer while the cannula is positioned in the subject.

5. The method of claim 1, further comprising:

moving the implantable device through the cannula and into the subject;

operating an insertion instrument extending through the cannula to deploy the implantable device at the interspinous space; and

after deploying the implantable device, removing the insertion instrument from the cannula.

6. The method of claim 1, further comprising moving the cannula along a delivery path that is substantially parallel to the subject'"'"'s midplane to position the cannula between the first and second spinous processes.

7. The method of claim 1, further comprising expanding the implantable device positioned at the interspinous space to distract and/or stabilize adjacent vertebrae.

8. The method of claim 1, further comprising inserting an instrument through the cannula while a holding device holds the cannula, and wherein the holding device is configured to control alignment and insertion depth of the cannula relative to the subject.

9. The method of claim 1, further comprising:

clamping a holding device onto the cannula;

inserting an instrument through the cannula while the cannula is held by the holding device; and

releasing the cannula from the holding device.

10. The method of claim 1 wherein the cannula has a longitudinal axis that is at a generally anterior-to-posterior orientation relative to the subject when deploying the implantable device.

11. A method for treating a subject, comprising:

moving a first dilator through an opening in the subject'"'"'s supraspinous ligament;

moving a second dilator through the opening to dilate the opening in the supraspinous ligament;

moving a cannula through the opening in the supraspinous ligament;

moving an implantable device through the cannula while the cannula is positioned in the opening in the supraspinous ligament; and

deploying the implantable device to distract and/or stabilize adjacent first and second vertebrae, wherein deploying the implantable device comprises;

rotating a first cam lobe of the implantable device to position a first spinous process of the first vertebra between arms of the first cam lobe; and

rotating a second cam lobe of the implantable device to position a second spinous process of the second vertebra process between arms of the second cam lobe.

12. The method of claim 11, further comprising:

operating an insertion instrument releasably coupled to the implantable device while the insertion instrument is coupled to the implantable device and extends through the cannula;

releasing the implantable device from the insertion instrument; and

removing the insertion instrument from the cannula.

13. The method of claim 11, further comprising mechanically deploying the implantable device using an insertion instrument extending through the cannula while a longitudinal axis of the cannula is at a substantially anterior-to-posterior orientation relative to the subject.

14. The method of claim 11, further comprising:

distracting the first and second spinous processes by inserting a tapered end portion of the cannula between the first and second spinous processes; and

delivering one or more instruments through the cannula to remove bone and/or soft tissue prior to deploying the implantable device.

15. The method of claim 11, further comprising delivering one or more instruments through the cannula to remove bone and/or soft tissue to create

a channel through which the implantable device can be inserted, and/or

a working space for the implantable device.

16. The method of claim 11, further comprising:

moving an instrument through the opening to separate portions of the supraspinous ligament from one another before moving the first dilator through the opening.

17. The method of claim 11, further comprising:

forming the opening in the subject'"'"'s supraspinous ligament using an interspinous knife;

inserting a guidewire through the opening;

holding the guidewire using a K-wire clamp;

moving the first dilator over the guidewire and through the opening;

removing tissue using a reamer;

measuring a distance between the first and second vertebrae using a interspinous gauge; and

moving the implantable device between the first and second vertebrae while the implantable device is held by an insertion instrument extending through the cannula.

18. A method for treating a subject comprising:

moving one or more dilators through an opening in the subject'"'"'s supraspinous ligament;

moving a cannula through the opening in the supraspinous ligament;

moving an implantable device through the cannula that is positioned in the opening in the supraspinous ligament, the implantable device including a first cam lobe and a second cam lobe, the first cam lobe having first arms, the second cam lobe having second arms; and

rotating the first and second cam lobes of the implantable device to position a first spinous process of a first vertebra between the first arms of the first cam lobe and to position a second spinous process of a second vertebra between arms of the second cam lobe.

19. The method of claim 18, wherein moving the one or more dilators through the opening in the subject'"'"'s supraspinous ligament includes sequentially moving a first dilator and a second dilator through the opening.

20. The method of claim 18, wherein each of the one or more dilators is configured to distract and/or space apart the first and second spinous processes.