IP Library Granted Patent US 10,980,563
Granted Patent B2
US 10,980,563 · App. 15/850,662 · Granted Apr 20, 2021

Minimally invasive methods for spinal facet therapy to alleviate pain and associated surgical tools, kits and instructional media

Inventors: Scott M. W. Haufe (Niceville, FL); Adam L. Gullickson (Stillwater, MN); Robert D. Carter (Apple Valley, MN)
Assignee: Medovex Corp.
A61B17/32002A61B17/3417A61B17/3421A61B18/02A61B18/1482A61B18/20A61B2017/320032A61B2017/347A61B2017/3407A61B2017/3492A61B2018/00339A61B2018/00595A61N7/022
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Quick Facts
Patent No.
US 10,980,563
App. No.
15/850,662
Granted
Apr 20, 2021
Kind
B2
Abstract

Methods and surgical tools for treating back pain use a spinal facet debridement tool with cautery and denuding action and minimally invasive protocol that can denude and cauterize soft tissue associated with a synovial capsule of the spinal facet joint whereby the synovial capsule between the spinal facet joint is removed by rotating the head of the combination debrider tool at a low rotation speed to scrape and cauterize the end plate receptor region so as to denude and denervate the joint preventing regeneration, and thereby treating back pain.

Claims (24)

1. A method of minimally invasively treating a patient for back pain, comprising: inserting a guide pin into the patient to a target spinal facet joint; sliding a dilation tube longitudinally over the guide pin into the patient so that the dilation tube distal end resides adjacent the target spinal facet joint over a synovial capsule of the target spinal facet joint, wherein the dilation tube has a distal end with a tapered shape; slidably advancing a cannula longitudinally over the dilation tube so that a distal end of the cannula resides adjacent the target spinal facet joint; then sliding the dilation tube longitudinally rearward over the guide pin out of the patient while the distal end of the cannula remains adjacent the target spinal facet joint; then inserting a debrider tool barrel having a denuding and cauterization head through the cannula in a straight path to the target spinal facet joint; then denuding and cauterizing soft tissue at the target spinal facet joint, serially or concurrently, using the denuding and cauterization head, wherein the denuding is carried out by rotating the denuding and cauterization head of the debrider tool barrel to remove an end plate receptor region comprising the synovial capsule of the target spinal facet joint thereby treating back pain, wherein during the denuding and the cauterizing, the cannula is configured to cooperate with the debrider tool barrel to position a distal end of the denuding and cauterization head out of the distal end of the cannula only a distance in a range of about 2 mm to about 7 mm.

2. The method of claim 1 , wherein the denuding is carried out by electronically rotating the denuding and cauterization head at a speed of between 10-5000 rpm.

3. The method of claim 1 , wherein the denuding is carried out by electronically rotating the denuding and cauterization head at a speed of between about 10 to about 100 rpm.

4. The method of claim 1 , wherein the method is carried out as an outpatient procedure, and wherein the sliding the dilation tube, advancing the cannula, inserting the debrider tool barrel, and the denuding and cauterizing are carried out in a short time of between about 3-15 minutes per target spinal facet joint.

5. The method of claim 1 , wherein the denuding is carried out by automatically rotating the denuding and cauterization head electronically to remove soft capsular tissue and a superficial lining of the synovial capsule of the target spinal facet joint, then once the soft tissue is denuded, electronically rotating the denuding and cauterization head to contact an exposed outer surface of bone under the denuded tissue to cleanse and/or scrape the exposed outer bone surface thereat without removing bone.

6. The method of claim 5 , wherein the denuding is carried out so that the denuding and cauterization head has an active rotation that has a duration of between about 30 seconds to about 2 minutes.

7. The method of claim 5 , wherein the cleansing and/or scraping is carried out so that the denuding and cauterization head rotates for a duration of between about 10 seconds to about 2 minutes.

8. The method of claim 1 , further comprising placing an external stabilizer against skin of the patient over the target spinal facet joint before, during or after inserting the guide pin, then inserting the cannula into the external stabilizer and coupling the cannula to the stabilizer before the denuding and cauterizing, wherein the external stabilizer has a base with a bottom surface with a width that is in a range of 2-6 inches, and wherein the base is configured to conformably reside against the skin of the patient.

9. The method of claim 8 , further comprising tilting the cannula and the debrider tool barrel held therein while held in the external stabilizer to thereby treat a wider area of the target spinal facet joint.

10. The method of claim 8 , wherein the base merges into a tubular segment that resides above the base that releasably couples to the cannula.

11. The method of claim 1 , wherein the denuding and cauterization head comprises at least one electrically conductive linear cautery element defining an external surface extending straight across at least a medial segment at a distal end thereof.

12. The method of claim 1 , wherein the denuding and cauterization head has a fluted configuration with longitudinally extending curvilinear or straight flutes that extend over at least a major portion of a length of a shaft merging into the denuding and cauterization head to inhibit tissue aggregation and/or clogging during the denuding and cauterizing.

13. The method of claim 1 , wherein the denuding and cauterization head has a fluted configuration with longitudinally extending curvilinear or straight flutes and a tissue contacting denuding and cauterization surface with first and second denuding projections that are non-electrically conductive and defined by radially extending straight linear segments that are diametrically opposed and separated by an open gap with a linear cautery element extending in the open gap, orthogonal to the first and second denuding projections.

14. The method of claim 1 , wherein the denuding and cauterization head has an expandable operative configuration, and wherein the method further comprises, after the inserting step and before the denuding and cauterizing step, expanding the denuding and cauterization head to have a larger dimension in a lateral direction relative to its shape during the inserting step.

15. The method of claim 1 , further comprising electronically detecting when the denuding and cauterization head hits hard bone after denuding soft tissue and electronically generating an audible and/or visual output to a user.

16. The method of claim 1 , wherein the dilation tube comprises first and second cooperating tubes, a first inner tube defining the tapered distal end and a second cooperating tube with a tapered forward end that resides upstream of the distal end of the inner tube over the first inner tube, and wherein the second tube is shorter than the first tube and abuts and holds the cannula prior to the advancing step.

17. The method of claim 1 , wherein the dilation tube is slid into the patient with the cannula attached thereto, and wherein the cannula is held at a position upstream of the distal end of the dilation tube as the dilation tube is slid into the patient.

18. The method of claim 1 , wherein the target spinal facet joint is a lumbar spinal facet joint, and wherein the cannula and debrider tool barrel extend out of the patient at an angle of between about 10 to about 40 degrees laterally, perpendicular to the target spinal facet joint.

19. The method of claim 1 , wherein the target spinal facet joint is a cervical or thoracic spinal facet joint, and wherein the cannula and debrider tool barrel extend at an angle of between about 0 to about 10 degrees laterally, perpendicular to the target spinal facet joint.

20. The method of claim 1 , wherein the inserting the guide pin is carried out multiple times by inserting separate guide pins to different target spinal facet joints at a plurality of different levels, and wherein the inserting the guide pins into the target spinal facet joint is carried out prior to inserting a respective dilation tube at any level.

21. The method of claim 1 , wherein the inserting the guide pin into the patient is repeated so that two guide pins extend bilaterally from a respective target spinal facet joint and the other method steps are carried out on both sides of the respective target spinal facet joint serially using the two guide pins to thereby denude and cauterize the respective target spinal facet joint bilaterally within about 10-15 minutes.

22. The method of claim 1 , wherein the debrider tool barrel and/or the cannula comprises an axially and/or longitudinally extending guide pin channel that slidably extends over the guide pin.

23. The method of claim 1 , wherein the cannula comprises a longitudinally extending guide pin channel that slidably extends over the guide pin and is parallel to a cavity of the cannula that holds the debrider tool barrel.

24. The method of claim 1 , wherein the cannula comprises an electrically insulating material and externally visible indicia of depth.

Assignments (11)
ADDENDUM TO ASSIGNMENT RECORDED AT REEL 069101, FRAME 0001 ON OCTOBER 2, 2024 Recorded Nov 15, 2024
From: MEDOVEX LLC
To: MEDOVEX IP PTY LTD
Reel/Frame 069386/0224 →
ADDENDUM TO ASSIGNMENT RECORDED AT REEL 068705, FRAME 0939 ON AUGUST 20, 2024 Recorded Oct 24, 2024
From: MEDOVEX CORP.
To: MEDOVEX LLC
Reel/Frame 069238/0471 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 2, 2024
From: MEDOVEX LLC
To: MEDOVEX IP PTY LTD
Reel/Frame 069101/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 20, 2024
From: MEDOVEX CORP.
To: MEDOVEX LLC
Reel/Frame 068705/0939 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2023
From: MEDOVEX CORP
To: MEDOVEX LLC
Reel/Frame 065842/0661 →
SECURITY INTEREST Recorded Apr 8, 2021
From: H-CYTE, INC.
To: FWHC BRIDGE, LLC
Reel/Frame 055868/0073 →
SECURITY INTEREST Recorded Apr 22, 2020
From: H-CYTE, INC.
To: FWHC BRIDGE, LLC
Reel/Frame 052459/0711 →
SECURITY INTEREST Recorded Apr 14, 2020
From: H-CYTE, INC.
To: FWHC BRIDGE, LLC
Reel/Frame 052392/0486 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2017
From: HAUFE, SCOTT M.W.
To: MEDOVEX CORP.
Reel/Frame 044463/0781 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2017
From: GULLICKSON, ADAM L.; CARTER, ROBERT D.
To: DEVICIX, LLC
Reel/Frame 044464/0142 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2017
From: DEVICIX, LLC
To: MEDOVEX CORP.
Reel/Frame 044464/0814 →
Continuity (4)
Division 14257490 · Apr 21, 2014
Provisional Application 61977817 · Apr 10, 2014
Provisional Application 61815416 · Apr 24, 2013
Related Publication 20180132880A1 · May 17, 2018
Cited By (2)
US 12,239,362 US 12,685,583