IP Library Granted Patent US 8,790,403
Granted Patent B2
US 8,790,403 · App. 12/614,499 · Granted Jul 29, 2014

Monorail system

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Quick Facts
Patent No.
US 8,790,403
App. No.
12/614,499
Granted
Jul 29, 2014
Kind
B2
Abstract

Systems for improved methods of performing a spinal fusion procedure that include a monorail instrument having a sliding platform for additional instrumentation to allow controlled delivery of various instruments for disc preparation and implant insertion in order to protect the medial neural structures of the spine. The monorail instrument engages other instruments, including various instruments utilized to prepare the disc space as well as spinal fusion implants, for guided and controlled insertion into the disc space. The monorail instrument may be a distractor, and may include flutes for preparation of the disc space.

Claims (41)

1. A system for delivering surgical devices to a spinal column of a patient, comprising:

(a) a distractor instrument comprising a monorail on a lateral side, wherein the monorail comprises a single raised platform and two sides angled inwardly from the raised platform, and wherein the monorail extends substantially along a length of the distractor instrument, wherein rotation of the distractor instrument is configured to distract a disc space;

(b) an inserter instrument, comprising:

a first portion having a recessed channel along at least one lateral side for receiving the raised platform of the monorail, wherein the recessed channel engages the raised platform of the monorail to permit longitudinal movement between the distractor instrument and the inserter instrument and wherein once engaged, the distractor instrument and the inserter instrument cannot be disengaged laterally, the inserter instrument positionable in the distracted disc space after rotation of the distractor instrument;

a second portion including a shaft and a housing, wherein a threaded knob is disposed within the housing;

a rod disposed in the first portion and the second portion, wherein the rod comprises a threaded end protruding from a leading end of the inserter and is attached to the threaded knob so that the threaded knob controls circumferential movement of the rod; and

(c) a total disc replacement device comprising an opening for receiving the threaded end of the rod.

2. The system of claim 1 , wherein the distractor instrument further comprises a second lateral side having a single elongated member.

3. The system of claim 1 , wherein the distractor instrument further comprises at least one shoulder adjacent a leading end for limiting a distance at which the distractor instrument is inserted into the disc space.

4. The system of claim 3 , wherein the leading end of the distractor instrument comprises flutes for cutting away tissue.

5. The system of claim 1 , wherein the distractor instrument further comprises a handle.

6. The system of claim 1 , wherein the total disc replacement device is an implant.

7. The system of claim 6 , wherein the implant comprises a recessed channel along at least one lateral side for receiving the raised platform of the monorail, wherein the recessed channel of the implant engages the raised platform of the monorail to permit longitudinal movement between the distractor instrument and the implant and wherein once engaged, the distractor instrument and the implant cannot be disengaged laterally.

8. The system of claim 1 , further comprising at least one surgical instrument.

9. The system of claim 8 , wherein the at least one surgical instrument comprises a recessed channel along at least one lateral side for receiving the raised platform of the monorail, wherein the recessed channel of the at least one surgical instrument engages the raised platform of the monorail to permit longitudinal movement between the distractor instrument and the surgical instrument and wherein once engaged, the distractor instrument and the surgical instrument cannot be disengaged laterally.

10. The system of claim 9 , wherein the at least one surgical instrument is a chisel.

11. A method of performing spinal fusion surgery, comprising:

(a) inserting a distractor into a disc space, wherein the distractor comprises a monorail on at least one lateral side;

(b) distracting the disc space by rotating the distractor in a first direction;

(c) coupling a total disc replacement device to a threaded rod of an inserter by turning a threaded knob of the inserter in a first circumferential direction, the total disc replacement device having a channel for receiving the monorail of the distractor;

(d) engaging a recessed channel of the inserter and the recessed channel of the total disc replacement device with the monorail of the distractor;

(e) sliding the inserter and total disc replacement device longitudinally down the monorail and into the distracted disc space;

(f) decoupling the total disc replacement device from the inserter by turning the threaded knob in a second circumferential direction; and

(g) removing the inserter and distractor from the disc space.

12. The method of claim 11 , wherein the distractor is inserted into the disc space from an anterior approach.

13. The method of claim 11 , wherein the distractor is inserted into the disc space from a posterior approach.

14. The method of claim 11 , wherein the distractor is inserted into the disc space from a transforaminal approach.

15. The method of claim 11 , wherein the distractor is inserted into the disc space from an extreme lateral approach.

16. The method of claim 11 , wherein a first distractor including a monorail is inserted from a lateral approach on a first side of the disc space and a second distractor including a monorail is inserted from a lateral approach on a second side of the disc space.

17. The method of claim 11 , wherein the step of distracting the disc space is performed prior to the step of sliding the inserter and total disc replacement device.

18. The method of claim 11 , wherein the monorail is disposed on an exterior surface of the distractor.

19. A method of performing spinal surgery comprising:

inserting a distractor into a disc space between adjacent vertebral bodies, the distractor having a monorail extending laterally from one side thereof;

rotating the distractor in a first direction, thereby distracting the disc space;

providing an inserter, the inserter having a recess that is complementary to the monorail and a rod with a threaded end;

coupling a disc replacement to the threaded end of the rod, the disc replacement having a channel for receiving the monorail of the distractor;

engaging the inserter and the disc replacement to the distractor by sliding the inserter and the disc replacement longitudinally along the monorail;

positioning the disc replacement in the distracted disc space;

separating the disc replacement from the inserter; and

removing the inserter and the distractor from the distracted disc space.

20. The method of claim 19 , wherein once the inserter and the distractor are engaged, the inserter and the distractor are laterally fixed to one another.

Assignments (10)
PATENT SECURITY AGREEMENT Recorded Jun 16, 2025
From: K2M, INC.; VB SPINE US OPCO LLC; VB SPINE LLC
To: ANKURA TRUST COMPANY, LLC, AS COLLATERAL AGENT
Reel/Frame 071682/0116 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2025
From: STRYKER CORPORATION
To: VB SPINE US OPCO LLC
Reel/Frame 071312/0356 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2025
From: K2M, INC.
To: STRYKER CORPORATION
Reel/Frame 071271/0170 →
RELEASE OF SECURITY INTEREST Recorded Nov 9, 2018
From: SILICON VALLEY BANK
To: K2M, INC.; K2M HOLDINGS, INC.; K2M UK LIMITED
Reel/Frame 047496/0001 →
FIRST AMENDMENT TO PATENT SECURITY AGREEMENT Recorded Oct 22, 2014
From: K2M, INC.; K2M UNLIMITED; K2M HOLDINGS, INC.
To: SILICON VALLEY BANK
Reel/Frame 034034/0097 →
TERMINATION Recorded May 22, 2013
From: SILICON VALLEY BANK
To: K2M, INC.
Reel/Frame 030918/0426 →
SECURITY INTEREST Recorded Nov 1, 2012
From: K2M, INC.; K2M HOLDING, INC.; K2M UK LIMITED
To: SILICON VALLEY BANK
Reel/Frame 029489/0327 →
ADDENDUM TO INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 8, 2011
From: K2M, INC.
To: SILICON VALLEY BANK
Reel/Frame 026565/0482 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 24, 2010
From: MEDITECH ADVISORS, LLC
To: K2M, INC.
Reel/Frame 025418/0114 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2009
From: FLICKINGER, ERIC; SMITHWECK, TOM
To: MEDITECH ADVISORS, LLC
Reel/Frame 023662/0425 →