Spacer insertion instrument

• US 9,393,055 B2
• Filed: 11/25/2013
• Issued: 07/19/2016
• 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, Tebbe, Shawn, Kim, Daniel H.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US14/089,692
• Publication Number:
  US 20140081332A1
• Time in Patent Office: 967 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/025 Joint distractors
• 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 17/7074 Tools specially adapted for spinal fixation operations other than for bone removal or filler handling A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The insertion instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for relative translational motion with respect to the outer shaft. The relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts wherein such deflection causes engagement with a juxtapositioned interspinous spacer. The instrument further includes a driving tool configured for removable insertion into a proximal end of a passageway of the instrument.

Claims

1. A method for implanting an interspinous device having a spacer body and first and second wings, the method comprising:

inserting the interspinous device between a first spinous process and a second spinous process of a subject'"'"'s spine while an instrument is connected to the interspinous device;

deploying the interspinous device by rotating a driving tool of the instrument to rotate the first and second wings relative to the spacer body such that the first and second wings are positioned to hold the first and second spinous processes; and

disconnecting the interspinous device from the instrument by rotating a control of the instrument while the first and second wings are positioned to hold the first and second spinous processes and the control is located outside of the subject.

2. The method of claim 1 wherein deploying the interspinous device includes rotating the driving tool while a prong of the instrument is positioned within a prong receiving portion of the interspinous device such that the prong limits rotation of the spacer body.

3. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes moving prongs of the instrument from a clamping configuration for holding the interspinous device to an open configuration for releasing the interspinous device.

4. The method of claim 1 wherein the instrument includes a clamping assembly and a handle, and wherein rotating the driving tool includes

rotating the driving tool about an axis of rotation defined by the clamping assembly while the driving tool extends through the clamping assembly and extends through the handle positioned outside of the subject.

5. The method of claim 1 wherein the driving tool includes a proximal end with a driver handle and a distal end with an engaging bit, and wherein deploying the interspinous device includes

manually rotating the driver handle positioned proximally of a clamping tool of the instrument while the clamping tool of the instrument holds the spacer body and the engaging bit engages an actuation mechanism of the interspinous device, wherein the actuation mechanism is configured to rotate the first and second wings as the control rotates.

6. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes moving a clamping assembly of the instrument from a clamping configuration for holding the interspinous device to a release configuration for releasing the interspinous device.

7. The method of claim 1 wherein

the instrument includes

a handle, and

a clamping assembly coupleable to the handle, wherein the clamping assembly includes at least one prong, an outer shaft, and an inner shaft with a passageway for receiving the driving tool;

and

disconnecting the interspinous device from the instrument includes moving the at least one prong out of a prong receiving portion of the interspinous device by moving one of the outer and inner shafts.

8. The method of claim 7 wherein disconnecting the interspinous device includes rotating the control to move one of the outer and inner shafts with respect to the other to cause the at least one prong to move toward and/or away from a longitudinal axis of the instrument.

9. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes opening a clamping assembly of the instrument configured to hold the interspinous device.

10. The method of claim 1 wherein the instrument has a distal end that clamps onto the interspinous device, wherein rotation of the control causes the distal end to open and release the interspinous device.

11. A method for implanting an interspinous device having a spacer body and first and second wings using an instrument, the method comprising:

positioning the interspinous device at an interspinous space between a first spinous process and a second spinous process of a subject'"'"'s spine while the interspinous device is connected to the instrument, wherein the instrument includes a handle, an assembly, a driving tool, and a control;

moving the driving tool relative to the spacer body releasably held by the assembly to cause an actuator mechanism of the interspinous device to drive the first and second wings toward a deployed configuration for holding the first and second spinous process;

after deploying the first and second wings, rotating the control positioned external to the subject to cause the assembly to release the interspinous device; and

after releasing the interspinous device, removing the instrument from the subject while the first spinous process is between elongate arms of the first wing and the second spinous process is between elongate arms of the second wing.

12. The method of claim 11 wherein the driving tool is configured to be rotated independent of rotation of the control to rotate the first and second wings independently of the release of the interspinous device.

13. The method of claim 11 wherein rotating the control of the instrument includes rotating the control a sufficient amount to move prongs of the instrument out of respective prong receiving portions of the interspinous device and thereby release the interspinous device.

14. The method of claim 11 wherein

the instrument includes a clamping assembly movable from clamping configuration for holding the interspinous device to an open configuration for releasing the interspinous device, and

rotating the control of the instrument includes rotating the control a sufficient amount to move the clamping assembly toward the open configuration so as to release the interspinous device.

15. The method of claim 11 wherein moving the driving tool includes rotating the driving tool about an axis of rotation defined by a clamping assembly of the instrument while the driving tool is positioned within a passageway of the clamping assembly.

16. The method of claim 11 wherein

the driving tool includes a proximal end with a driver handle and a distal end with an engaging bit, and

moving the driving tool includes manually rotating the driver handle positioned proximally of a clamping assembly of the instrument while the engaging bit engages the interspinous device held by the clamping assembly.

17. The method of claim 11 wherein rotating the control of the instrument causes a clamping assembly of the instrument to move from an clamping configuration for holding the interspinous device to a release configuration for disconnecting from the interspinous device.

18. The method of claim 11 wherein

the instrument includes a handle and a clamping assembly coupleable to the handle, wherein the clamping assembly includes an outer shaft and an inner shaft with a passageway for receiving the driving tool, and

rotating the control includes moving the control a sufficient amount to move at least one prong out of a prong receiving portion of the interspinous device.

19. The method of claim 18 wherein rotation of the control causes one of the outer and inner shafts to move with respect to the other to cause the at least one prong to move toward or away from a longitudinal axis of the instrument.

20. The method of claim 11 wherein the instrument includes an assembly having a distal end with a clamping assembly, wherein rotation of the control includes moving the clamping assembly between a clamping configuration for holding the interspinous device and an open configuration for releasing the interspinous device independent of rotation of the driving tool.

21. The method of claim 11, further comprising moving the interspinous device along a midline approach to position the interspinous device at the interspinous space.