|Publication number||US20050125066 A1|
|Application number||US 11/007,648|
|Publication date||9 Jun 2005|
|Filing date||7 Dec 2004|
|Priority date||8 Dec 2003|
|Also published as||US7354453, US7887597, US20060271198, US20080200951, WO2005055874A2, WO2005055874A3|
|Publication number||007648, 11007648, US 2005/0125066 A1, US 2005/125066 A1, US 20050125066 A1, US 20050125066A1, US 2005125066 A1, US 2005125066A1, US-A1-20050125066, US-A1-2005125066, US2005/0125066A1, US2005/125066A1, US20050125066 A1, US20050125066A1, US2005125066 A1, US2005125066A1|
|Original Assignee||Innovative Spinal Technologies|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (8), Referenced by (50), Classifications (27), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority to U.S. Provisional Patent Application Ser. No. 60/527,855 entitled “Nucleus Replacement Securing Device and Method”, filed Dec. 8, 2003, the disclosure of which is hereby incorporated herein by reference.
This invention relates to securing of a nucleus replacement and more specifically, to assistance in placing, stabilizing, and securing of a nucleus replacement in the disc space between two adjacent vertebrae from a posterior, posterolateral, or lateral approach.
Spinal discs are the primary mechanical cushion for the vertebral column and permit controlled motion between the vertebral segments. Over time, these discs have a tendency to loose water which in turn reduces their cushioning ability. Along with a reduced hydraulic nature, the disc loses its ability to maintain disc height and bear loads resulting in a cascade of degenerative effects. As this degenerative process continues, a disc herniation involving bulging or expelling of disc material can occur leading to pain to the back and lower extremities. When this occurs, it is necessary to remove the herniated disc and reestablish disc height, ultimately in an effort to reduce or eliminate pain.
When the pain generating disc is removed, the disc space will collapse resulting in instability and further trauma to surrounding tissue and ensuing pain. Current treatments include installing a bone brace, cage, or other load bearing means often along with bone growth stimulators in an effort to cause fusion of the segment and thus alleviate the pain. This process is, however, believed to place undo stress on other vertebral levels as they compensate for the lack of motion, in turn potentially leading to premature failure of those other discs as well.
An improved solution includes replacing the removed internal portion of the disc, or the nucleus, with a nucleus prosthesis to act as the load bearing and motion stabilizing feature in an effort to restore natural spine biomechanics.
Devices such as these are outlined in U.S. Pat. No. 6,602,291 wherein the nucleus replacement is inserted into the disc space is a reduced size state, and then is hydrolyzed (or otherwise expanded) to fill the gap. Current methods and concepts have undergone human clinical trials to little success and suffers from an inability to access, place, and then finally secure the nucleus replacement in place. Several attempts at human trials have even resulted in expulsion of these devices out of the disc space. This problem must be addressed to make this technology a viable possibility in spine treatment.
There is disclosed systems and methods for spinal nucleus replacement by constructing channels through vertebral segments on either side of an area into which the spinal nucleus is to be positioned, the channels running from a channel end outside of the area to a channel end abutting the area. One end of a suture is inserted into the outside channel end of a first one of the channels and passed through the first channel and into the area and out of the area through the second channel until it emerges from the second channel. The suture is then used to pull the nucleus into the area.
In a first embodiment, an alignment device mounts to the posterior aspect of the spine and drills curved holes down through the pedicle of the segment and into the disc space of the level. At the adjoining level, holes are also drilled in the pedicle into the adjoining disc space so that each exit of the curved hole meet at a single disc space. A suture is then threaded through the first curved hole, to the disc space, then is extracted from the disc space to the posterior. The suture is threaded through a nucleus replacement, or through the covering around a nucleus replacement, and then back into the disc space where it is pulled through the second hole and out to the pedicle. Having a suture that goes through each pedicle and around the nucleus replacement allows the suture to be pulled from both ends to urge the nucleus replacement into position still secured to the suture. Plugs are then inserted into the pedicle and attached to the suture so as to fix the suture in place. The suture is then cut keeping the nucleus replacement in a fixed position within the disc space. The suture holds the nucleus replacement secured to a fixed position after it has been guided into place. While the nucleus replacement may be permitted a certain amount of movement in certain embodiments, it is secured within the disc space so as not to be expelled therefrom.
In a second embodiment, the ends of the suture expelled from both pedicles are joined with a tension band between the two pedicles that can act as a further stabilizing effect to the segment.
In a third embodiment, the pedicles of the same vertebra are used as access into the adjacent disc space. The two sutures or pathways are through the superior vertebral end place of the vertebra. This allows preservation of the entire periphery of the annulus fibrosis if the nucleus replacement is collapsible and can be inserted through the pedicle.
The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter. It should be appreciated that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized that such equivalent constructions do not depart from the invention. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention.
For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:
Turning now to
After the holes are drilled, a suture 60 starting with end 62 is passed through the L4 pedicle opening 55 a, through the first tunnel 53 a, and into the disc space 40 passing the entry point 54 a. In the first embodiment, the suture would then be grasped and pulled through a posterior opening in the disc space 40, and out to the posterior of the patient. Suture 60 is then mated to nucleus replacement 50, and suture 60 is passed back down the access port to the disc space 40 where it is guided back down to the second tunnel 53 b through opening 54 b. As an aide, a tool could be passed through the opening of pedicle 55 b, through tunnel 53 b, into the disc space 40. The tool would grab suture 60 and pull end 62 through opening 54 b, through tunnel 53 b, and out to pedicle opening 55 b where it is pulled out of the body.
This method leaves end 62 of suture 60 extending out of the patient and the opposite end 61 of suture 60 also extending out of the patient. The suture would most likely have been cut off at the appropriate length. Suture ends 61, 62 are then pulled out away from the patent, pulling with it nucleus prosthesis 50 that is attached to suture 60. In this way, nucleus replacement 50 is pulled into disc space 40 so that holes 54 a, 54 b are directly in line with the suture connection point at the nucleus prosthesis.
At this point knots, anchors (not shown) or other stop devices could be attached to suture ends 61, 62. If anchors are used, they would be forcibly press fitted or threaded into the pedicle. The anchors could have features on them that mate with the suture to allow tension and reduction of length on suture ends 61, 62 in a zip tie approach so as to maintain position of suture 60 and thus of nucleus replacement 50 at all times. The remaining suture ends would then be cut off flush or above flush to the anchors.
In another embodiment, end 62 of suture 60, while being installed, would pass from opening 54 a of disc space 40 directly into opening 54 b and urged through tunnel 53 b to opening 55 b of the L5 pedicle and pulled out of the patient. With end 62 of suture 60 extending out of the patient, a tool could be inserted through opening 56 to disc space 40, grabbing the suture 60 and pulling slack granted at either end through opening 56 and out of the patient. At this point, nucleus 50 would be harnessed to suture 60 at points 51 and 52. In so doing, nucleus replacement 50 is now secured to suture 60. Slack from suture 60 can now be pulled out by suture ends 61, 62, thereby pulling nucleus replacement 50 into disc space 40, with points 51, 52 positioned in line with openings 54 a, 54 b. Anchors would then be applied in the manner and fashion described above.
While in some instances nucleus replacement 50 may be a single device, in other implementations it may include multiple devices that are inserted into disc space 40. Turning to
As a method, the nucleus replacements 50 a, 50 b are passed through cannulas 210, 211, through opening 56 a, 56 b of the disc space, and passed into the disc space 40. The nucleus replacement travel ends when holes 51 a, 51 b, and 52 a, 52 b (not shown), line up with holes 54 a, 54 b and 64 a, 64 b (not shown) with suture 60 a passing though the left prosthesis 50 a, and suture 60 b passing through the right prosthesis 50 b.
Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the invention. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one will readily appreciate from the disclosure, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized. Accordingly, the invention is intended to encompass within its scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4790303 *||11 Mar 1987||13 Dec 1988||Acromed Corporation||Apparatus and method for securing bone graft|
|US6277120 *||20 Sep 2000||21 Aug 2001||Kevin Jon Lawson||Cable-anchor system for spinal fixation|
|US6368326 *||28 Sep 1998||9 Apr 2002||Daos Limited||Internal cord fixation device|
|US6551320 *||5 Jul 2001||22 Apr 2003||The Cleveland Clinic Foundation||Method and apparatus for correcting spinal deformity|
|US6602291 *||5 Apr 1999||5 Aug 2003||Raymedica, Inc.||Prosthetic spinal disc nucleus having a shape change characteristic|
|US6610064 *||9 Aug 2000||26 Aug 2003||Ethicon, Inc.||Apparatus and method for reconstructing a ligament|
|US6645211 *||7 Feb 2001||11 Nov 2003||Howmedica Osteonics Corp.||Orthopedic support system and method of installation|
|US6923811 *||10 May 2000||2 Aug 2005||Spray Venture Partners||Systems and methods for spinal fixation|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7666226||15 Aug 2006||23 Feb 2010||Benvenue Medical, Inc.||Spinal tissue distraction devices|
|US7666227||15 Aug 2006||23 Feb 2010||Benvenue Medical, Inc.||Devices for limiting the movement of material introduced between layers of spinal tissue|
|US7670374||15 Aug 2006||2 Mar 2010||Benvenue Medical, Inc.||Methods of distracting tissue layers of the human spine|
|US7670375||15 Aug 2006||2 Mar 2010||Benvenue Medical, Inc.||Methods for limiting the movement of material introduced between layers of spinal tissue|
|US7713303||28 Apr 2005||11 May 2010||Warsaw Orthopedic, Inc.||Collagen-based materials and methods for augmenting intervertebral discs|
|US7731981||23 Jan 2007||8 Jun 2010||Warsaw Orthopedic, Inc.||Collagen-based materials and methods for treating synovial joints|
|US7740659||29 Jun 2006||22 Jun 2010||Depuy Spine, Inc.||Insert for nucleus implant|
|US7744651||6 Jan 2005||29 Jun 2010||Warsaw Orthopedic, Inc||Compositions and methods for treating intervertebral discs with collagen-based materials|
|US7763074||15 Dec 2005||27 Jul 2010||The Board Of Trustees Of The Leland Stanford Junior University||Systems and methods for posterior dynamic stabilization of the spine|
|US7785368||15 Aug 2006||31 Aug 2010||Benvenue Medical, Inc.||Spinal tissue distraction devices|
|US7828847||15 Feb 2007||9 Nov 2010||Samy Abdou||Devices and methods for inter-vertebral orthopedic device placement|
|US7935134||29 Jun 2006||3 May 2011||Exactech, Inc.||Systems and methods for stabilization of bone structures|
|US7955391||15 Feb 2010||7 Jun 2011||Benvenue Medical, Inc.||Methods for limiting the movement of material introduced between layers of spinal tissue|
|US7963970||22 Nov 2006||21 Jun 2011||Trinity Orthopedics||Percutaneous transpedicular access, fusion, discectomy, and stabilization system and method|
|US7985242||23 Mar 2007||26 Jul 2011||Zimmer Spine, Inc.||Instruments and methods for reduction of vertebral bodies|
|US7993376 *||30 Nov 2005||9 Aug 2011||Depuy Spine, Inc.||Methods of implanting a motion segment repair system|
|US8123807||6 Dec 2004||28 Feb 2012||Vertiflex, Inc.||Systems and methods for posterior dynamic stabilization of the spine|
|US8163019||21 Dec 2007||24 Apr 2012||Pioneer Surgical Technology, Inc.||Implant restraint device and methods|
|US8167944||1 May 2012||The Board Of Trustees Of The Leland Stanford Junior University||Systems and methods for posterior dynamic stabilization of the spine|
|US8303660||23 Apr 2007||6 Nov 2012||Samy Abdou||Inter-vertebral disc prosthesis with variable rotational stop and methods of use|
|US8409258 *||2 Jun 2008||2 Apr 2013||Polyvalor, Limited Partnership||Fusionless vertebral physeal device and method|
|US8439925||11 May 2010||14 May 2013||Trinity Orthopedics, Llc||Transiliac-transsacral method of performing lumbar spinal interventions|
|US8454617||4 Jun 2013||Benvenue Medical, Inc.||Devices for treating the spine|
|US8500814||30 Sep 2010||6 Aug 2013||Samy Abdou||Devices and methods for inter-vertebral orthopedic device placement|
|US8540772 *||22 Sep 2008||24 Sep 2013||Said G. Osman||Transpedicular, extrapedicular and transcorporeal partial disc replacement|
|US8740948||15 Dec 2010||3 Jun 2014||Vertiflex, Inc.||Spinal spacer for cervical and other vertebra, and associated systems and methods|
|US8771355||29 May 2007||8 Jul 2014||M. S. Abdou||Inter-vertebral disc motion devices and methods of use|
|US8777957||14 Jun 2011||15 Jul 2014||Trinity Orthopedics, Llc||Percutaneous transpedicular access, fusion, discectomy, and stabilization system and method|
|US8790375||16 Mar 2012||29 Jul 2014||Raed M. Ali, M.D., Inc.||Transpedicular access to intervertebral spaces and related spinal fusion systems and methods|
|US8808382||21 Dec 2007||19 Aug 2014||Pioneer Surgical Technology, Inc.||Implant retention device and method|
|US8864772||20 Jan 2011||21 Oct 2014||DePuy Synthes Products, LLC||Motion segment repair systems and methods|
|US8864828||15 Jan 2009||21 Oct 2014||Vertiflex, Inc.||Interspinous spacer|
|US8900271||1 May 2012||2 Dec 2014||The Board Of Trustees Of The Leland Stanford Junior University||Systems and methods for posterior dynamic stabilization of the spine|
|US8968408||24 Apr 2013||3 Mar 2015||Benvenue Medical, Inc.||Devices for treating the spine|
|US9011497 *||2 Jul 2008||21 Apr 2015||Scorpion Surgical Technologies Ltd.||Bone anchoring system|
|US9039742||9 Apr 2012||26 May 2015||The Board Of Trustees Of The Leland Stanford Junior University||Systems and methods for posterior dynamic stabilization of the spine|
|US9044338||12 Mar 2013||2 Jun 2015||Benvenue Medical, Inc.||Spinal tissue distraction devices|
|US9066808||20 Feb 2009||30 Jun 2015||Benvenue Medical, Inc.||Method of interdigitating flowable material with bone tissue|
|US20040186471 *||7 Dec 2002||23 Sep 2004||Sdgi Holdings, Inc.||Method and apparatus for intervertebral disc expansion|
|US20050119754 *||6 Jan 2005||2 Jun 2005||Trieu Hai H.||Compositions and methods for treating intervertebral discs with collagen-based materials|
|US20090082870 *||22 Sep 2008||26 Mar 2009||Osman Said G||Transpedicular, extrapedicular and transcorporeal partial disc replacement|
|US20100305700 *||2 Jul 2008||2 Dec 2010||Asaf Ben-Arye||Bone anchoring system|
|US20130041469 *||2 Aug 2012||14 Feb 2013||Jeff Phelps||Interbody axis cage|
|US20130090690 *||11 Apr 2013||David A. Walsh||Dynamic Rod Assembly|
|EP2173264A2 *||2 Jul 2008||14 Apr 2010||Scorpion Surgical Technologies LTD.||Bone anchoring system|
|EP2173264A4 *||2 Jul 2008||3 Apr 2013||Scorpion Surgical Technologies Ltd||Bone anchoring system|
|EP2420209A1 *||31 Aug 2006||22 Feb 2012||Spinal Kinetics, Inc.||Prosthetic Intervertebral Discs|
|WO2007040879A2 *||5 Sep 2006||12 Apr 2007||Depuy Spine Inc||Motion segment repair system|
|WO2007130159A2 *||10 Jan 2007||15 Nov 2007||Depuy Spine Inc||Method and instruments for intervertebral disc augmentation through a pedicular approach|
|WO2008005252A1 *||27 Jun 2007||10 Jan 2008||Spinemedica Corp||Spinal implants with cooperating anchoring sutures|
|U.S. Classification||623/17.16, 623/908|
|International Classification||A61F2/00, A61F2/30, A61B17/04, A61F2/46, A61F2/44, A61B17/84|
|Cooperative Classification||A61F2002/30133, A61F2002/444, A61F2002/30235, A61F2002/448, A61F2002/30462, A61B17/0401, A61F2/4611, A61B17/842, A61F2230/0015, A61F2220/0075, A61F2310/00029, A61B2017/0458, A61B2017/0414, A61F2/442, A61F2230/0069, A61F2002/30909|
|European Classification||A61B17/04A, A61F2/46B7, A61F2/44D|
|14 Feb 2005||AS||Assignment|
Owner name: INNOVATIVE SPINAL TECHNOLOGIES, TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MCAFEE, PAUL;REEL/FRAME:016258/0831
Effective date: 20050107
|28 Oct 2008||AS||Assignment|
Owner name: SILICON VALLEY BANK, AS AGENT AND AS A LENDER,MASS
Free format text: SECURITY AGREEMENT;ASSIGNOR:INNOVATIVE SPINAL TECHNOLOGIES, INC.;REEL/FRAME:021750/0493
Effective date: 20080912
|14 Sep 2009||AS||Assignment|
Owner name: THEKEN SPINE, LLC,OHIO
Free format text: TERMINATION AND RELEASE OF SECURITY INTEREST;ASSIGNORS:SILICON VALLEY BANK;GE BUSINESS FINANCIAL SERVICES, INC.;REEL/FRAME:023228/0001
Effective date: 20090910
|15 Sep 2009||AS||Assignment|
Owner name: THEKEN SPINE, LLC,OHIO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:WARREN E. AGIN, QUALIFIED CHAPTER 7 TRUSTEE IN BANKRUPTCYFOR INNOVATIVE SPINAL TECHNOLOGIES, INC.;REEL/FRAME:023233/0395
Effective date: 20090910