Cervical distraction method

• US 7,824,431 B2
• Filed: 04/28/2008
• Issued: 11/02/2010
• Est. Priority Date: 12/29/2006
• Status: Active Grant

• Current Assignee: Providence Medical Technology, Inc.
• Original Assignee: Providence Medical Technology, Inc.
• Inventors: McCormack, Bruce
• Primary Examiner(s): RAMANA, ANURADHA
• Application Number:
  US12/110,548
• Publication Number:
  US 20080208341A1
• Time in Patent Office: 918 Days
• Field of Search: 606/247, 623 1711- 1716
• US Class Current: 606/279
• CPC Class Codes: A61B 17/562 Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 2017/681 Alignment, compression, or distraction mechanisms
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4611 of spinal prostheses

Abstract

A device and method for a minimally invasive surgical implantation to reduce radicular symptoms by inserting an expandable cervical distraction implant in the facet joint and distracting the adjacent cervical vertebrae to increase the foraminal dimension. The implant, when positioned in the cervical facet joint, expands via delivery of an inflation medium to increase the space between the vertebrae, thereby increasing the foraminal area or dimension, and reducing pressure on the nerves and blood vessels of the cervical spine.

Claims

1. A method for increasing foraminal height between first and second adjacent vertebrae of a patient under conscious sedation, the adjacent vertebrae having a facet joint comprising opposing articulating surfaces of adjacent vertebrae and a joint capsule that extends beyond the margin of the articulating surfaces, the opposing articulating surfaces having a shape and a relative orientation defining a geometry of a patient anatomy, the method comprising:

determining the geometry of the patient anatomy;

selecting an implant from a plurality of inflatable implants, each implant comprised of an inelastic material, wherein a geometry of the selected implant corresponds to the geometry of the patient anatomy and an intended reversal of narrowing of a nerve root canal of the patient;

creating an access hole through the joint capsule with an introducer needle;

injecting dye through the introducer needle;

fluoroscopically confirming that the introducer needle is positioned in the facet joint;

inserting the selected implant through the needle and into the facet joint with a catheter, the selected implant being in a collapsed configuration and being connected to a distal end of the catheter;

positioning the selected implant such that the geometry of the selected implant corresponds to the geometry of the patient anatomy;

inflating the selected implant within the facet joint by advancing a bio-inert hydrogel through the catheter and into the selected implant with a catheter inflation syringe, the hydrogel including a contrast dye;

monitoring the inflating via a monitor positioned on the syringe;

fluoroscopically monitoring the inflating via the contrast dye in the hydrogel;

obtaining intra-operative patient feedback regarding symptom improvement;

iteratively adiustinq the inflating of the selected implant according to patient feedback.

2. A method as recited in claim 1, wherein the selected implant in the fully inflated configuration retains the increased foraminal dimension while allowing motion of the first vertebrae with respect to the second vertebrae.

3. A method as recited in claim 1, wherein the selected implant, in the inflated configuration, has a length corresponding to the depth of the facet joint, and a height corresponding to the desired distraction of the facet joint height to achieve said increased foraminal dimension.

4. A method as recited in claim 3:

wherein, in the inflated configuration, the length of the selected implant occupies the majority of the facet joint depth; and

wherein the width of the selected implant occupies at least the center third of the facet joint width.

5. A method as recited in claim 1, wherein the patient feedback is used to set the fully inflated height of the selected implant.

6. The method as recited in claim 1, wherein the selected implant includes a self sealing mechanism at the connection to the catheter, the method further comprising detaching the catheter from the selected implant and withdrawing the catheter.

7. The method as recited in claim 1, wherein the implant includes a central lumen and inserting the selected implant includes advancing the selected implant and catheter over a guide wire.

8. The method as recited in claim 1, wherein the selected implant has a tapered shape adapted to accommodate the geometry of the patient anatomy.