This invention relates generally to the prosthetic appliances and, in particular, to devices for occluding intervertebral disc defects and instrumentation associated with introducing the such devices.
Several hundred thousand patients undergo disc operations each year. Approximately five percent of these patients will suffer recurrent disc herniation, which results from a void or defect which remains in the outer layer (annulus fibrosis) of the disc after surgery involving partial discectomy.
Reference is made to
The subject invention resides in methods and apparatus for treating disc herniation, which may be defined as the escape of nucleus pulposus through a void or defect in the annulus fibrosis of a spinal disc situated between upper and lower vertebra. In addition to preventing the release of natural disc materials, the invention may also be used to retain bone graft for fusion, therapeutic and artificial disc replacement materials. The invention is particularly well suited to the minimization and prevention of recurrent disc herniation, in which case the defect is a hole or void which remains in the annulus fibrosis following disc operations involving partial discectomy.
In broad, general terms, to correct defects of this type, the invention provides a conformable device which assumes a first shape associated with insertion and a second shape or expanded shape to occlude the defect. The device may take different forms according to the invention, including solidifying gels or other liquids or semi-liquids, patches sized to cover the defect, or plugs adapted to fill the defect.
The device is preferably collapsible into some form for the purposes of insertion, thereby minimizing the size of the requisite incision while avoiding delicate surrounding nerves. Such a configuration also permits the use of instrumentation to install the device, including, for example, a hollow tube and a push rod to expel the device or liquefied material out of the sheath for use in occluding the disc defect.
A device according to the invention may further include one or more anchors to assist in permanently affixing the device with respect to the defect. For example, in the embodiment of a mesh screen, the anchors may assume the form of peripheral hooks configured to engage with the vertebra on either side of the disc. The invention further contemplates a distracting tool used to force the anchors into the vertebra. Such a tool would preferably feature a distal head portion conformal to the expanded shape of the device, enabling the surgeon to exert force on the overall structure, thereby setting the anchors.
Having discussed the problems associated with post-operative partial discectomy with respect to
A flexible device is also preferred because the surgeon is presented with a very small working area. The incision through the skin is typically on the order of 1 to 1.5 inches in length, and the space at the disc level is approximately 1 centimeter on the side. As a consequence, the inventive device and the tools associated with insertion and fixation described below must be sufficiently narrow to fit within these confines.
As shown in
To further assist in fixation with respect to the surrounding physiology, anchors 402 may be provided around a peripheral edge of the device, as shown in
In terms of a preferred material, a device according to the invention will therefore remain sufficiently flexible during movement while being capable of exerting continuous outward forces and withstanding repetitive compression and distraction of millions of cycles. The device would, therefore, preferably be made of a material that has these characteristics, while, additionally being radio-opaque for X-ray imaging, without producing too many unwanted artifacts in magnetic resonance imaging. A wire mesh of titanium is therefore preferable, since this has the proper X-ray/MRI characteristics while exhibiting the requisite flexibility for the cyclic flexion and extension. With respect to the embodiment of
The invention is not limited in the sense that any conformable device may be used with a first shape permitting the device to be introduced into the defective area and a second shape wherein the device includes a defect. As shown in
As yet a different alternative mode of introduction, a material may be injected into the disc in liquid form, then allowed to hardened into a size sufficient to occlude the annular hole. As shown in
Various materials may be utilized for this purpose, including various polymers which are caused to solidify by various means, including thermal or optical activation, or chemical reaction as part of multi-part compounds. A preferred material with respect to this embodiment would be a hydrogel. Hydrogels may be placed into the disc in a dehydrated state, and, once inside the disc, they imbibe water. After hydration, hydrogels have the same biomechanical properties as a natural nucleus and, in addition, as the hydrogels swell, they become too large to extrude back through the annular window. U.S. Pat. Nos. 5,047,055 and 5,192,326 provide a listing of hydrogels, certain of which are applicable to this invention.
An elastomer may be used as an alternative to a hydrogel or other material. A number of elastomers may be suited to the invention, including a silicon elastomer, which comprises a cured dimethylsiloxane polymer and Hexsyn, having a composition of one-hexane with three to five percent methylhexaiene. A preformed elastomer may be inserted into the inclusion upon curing or, alternatively, as discussed with reference to
Now making to
In addition to the use of patches attached with sutures, staples or other materials, the annular defect may be closed with staples or other devices which attach to the annulus without the need for patch material. For example, as shown in
The use of flexible stents as described elsewhere herein may take on other forms, as shown in
As shown in
Certain of the following embodiments illustrate how the invention permits the use of a flexible device which allows movement between the vertebrae yet blocks extrusion of nucleus through an annular hole or defect. In
As an alternative to inherently flexible materials which occlude a defect while accommodating compression and distraction, interleaving members may alternatively be used, as shown in
As a further alternative configuration, a collapsed bag may be placed into the disc space, then filled with a gas, liquid or gel once in position. The bag may be empty, or may contain a stent or expanding shape to assist with formation. In the case of a gel, silicon may be introduced so as to polymerized or solidify. As shown in
It is noted that, depending upon the configuration, that the invention may make use of a bioabsorbable materials, that is, materials which dissolve in the body after a predetermined period of time. For example, if darts such as those shown in
Disc fusions are generally performed for degenerative disc disease, spondylolysis (a stress fracture through the vertebra), spondylolisthesis (slippage of one vertebra on another), arthritis of the facet joints, spinal fractures, spinal tumors, recurrent disc herniations, and spinal instability. The procedure attempts to eliminate motion between vertebra to decrease a patient's pain and/or prevent future problems at the intervertebral level.
Devices such as spinal cages are generally used in conjunction with such procedures to maintain the separation between the vertebrae until fusion occurs. Some surgeons believe that cages are not necessary to maintain the separation, and instead use pedicle screws or hooks and rods to perform this function. Whether or not a cage is used, bone graft is generally introduced through a hole formed in the disc space to achieve an interbody fusion.
Unfortunately, bone material placed into the disc space can extrude through the hole used for insertion. Bone graft extruded through a hole in the posterior portion of the disc may cause nerve root impingement. The procedure to fuse vertebra across the disc space from a posterior approach is known as a PLIF (posterior lumbar interbody fusion). Bone can also be placed into the disc space from an anterior approach ALIF (anterior lumbar interbody fusion). Extruded bone from an anterior approach would not lead to nerve impingement but could decrease the likelihood of a successful fusion by decreasing the volume of bone graft.
The present invention may be used to prevent the loss of the bone graft material associated with fusion techniques, whether or not a cage is used. In this particular regard, however, some of the devices disclosed herein may be more suitable than others. Generally speaking, since the goal is not to preserve disc function and motion, the stent, plug, and patch embodiments may be more appropriate. Although the plug embodiment would be a good choice when there is ample room in the spinal canal to allow insertion, the expandable stent design would be beneficial when plug insertion risks nerve injury. Conversely, since the goal is to maximize the amount of bone inserted into the disc space, the embodiments using hydrogels and elastomers might not be optimum, since such materials may occupy too much space in some circumstances.
The preferred choice of materials may also be changed since motion is not being maintained. Materials and designs with shape memory may be beneficial. As another example, the polymer plug embodiment may changed to a metal such as titanium. A metal plug may be fabricated with threads and screwed into place, as shown in
This application is a continuation of U.S. application Ser. No. 09/638,241, filed Aug. 14, 2000, which claims priority from U.S. Provisional Patent Application Ser. No. 60/148,913, filed Aug. 13, 1999. U.S. application Ser. No. 09/638,241 is also a continuation-in-part of International Patent Application No. PCT/US00/14708, filed May 30, 2000, which is a continuation-in-part of and claims the benefit under 35 USC §119 of U.S. application Ser. No. 09/322,516, filed May 28, 1999, now U.S. Pat. No. 6,245,107. The entire content of each application and patent is incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3867728 | Stubstad et al. | Feb 1975 | A |
3875595 | Froning | Apr 1975 | A |
4349921 | Kuntz | Sep 1982 | A |
4413359 | Akiyama et al. | Nov 1983 | A |
4502161 | Wall | Mar 1985 | A |
4512338 | Balko et al. | Apr 1985 | A |
4532926 | O'Holla | Aug 1985 | A |
4663358 | Hyon et al. | May 1987 | A |
4665906 | Jervis | May 1987 | A |
4741330 | Hayhurst | May 1988 | A |
4744364 | Kensey | May 1988 | A |
4772287 | Ray et al. | Sep 1988 | A |
4781190 | Lee | Nov 1988 | A |
4798205 | Bonomo et al. | Jan 1989 | A |
4834757 | Brantigan | May 1989 | A |
4837285 | Berg et al. | Jun 1989 | A |
4852568 | Kensey | Aug 1989 | A |
4863477 | Monson | Sep 1989 | A |
4873976 | Schreiber | Oct 1989 | A |
4890612 | Kensey | Jan 1990 | A |
4904260 | Ray et al. | Feb 1990 | A |
4911718 | Lee et al. | Mar 1990 | A |
4917704 | Frey et al. | Apr 1990 | A |
4932969 | Frey et al. | Jun 1990 | A |
4946378 | Hirayama et al. | Aug 1990 | A |
4955908 | Frey et al. | Sep 1990 | A |
5002576 | Fuhrmann et al. | Mar 1991 | A |
5015255 | Kuslich | May 1991 | A |
5021059 | Kensey et al. | Jun 1991 | A |
5035716 | Downey | Jul 1991 | A |
5047055 | Bao et al. | Sep 1991 | A |
5053046 | Janese | Oct 1991 | A |
5059206 | Winters | Oct 1991 | A |
5061274 | Kensey | Oct 1991 | A |
5071437 | Steffee, Arthur D. | Dec 1991 | A |
5100422 | Berguer et al. | Mar 1992 | A |
5108438 | Stone | Apr 1992 | A |
5116357 | Eberbach | May 1992 | A |
5122155 | Eberbach | Jun 1992 | A |
5123926 | Pisharodi | Jun 1992 | A |
5141515 | Eberbach | Aug 1992 | A |
5147374 | Fernandez | Sep 1992 | A |
5171259 | Inoue | Dec 1992 | A |
5171278 | Pisharodi | Dec 1992 | A |
5171280 | Baumgartner | Dec 1992 | A |
5171281 | Parsons et al. | Dec 1992 | A |
5176692 | Wilk et al. | Jan 1993 | A |
5192326 | Bao et al. | Mar 1993 | A |
5222974 | Kensey et al. | Jun 1993 | A |
5254133 | Seid | Oct 1993 | A |
5258000 | Gianturco | Nov 1993 | A |
5258043 | Stone | Nov 1993 | A |
5269783 | Sander | Dec 1993 | A |
5282827 | Kensey et al. | Feb 1994 | A |
5304194 | Chee et al. | Apr 1994 | A |
5306311 | Stone et al. | Apr 1994 | A |
5312435 | Nash et al. | May 1994 | A |
5318780 | Viegas et al. | Jun 1994 | A |
5320633 | Allen et al. | Jun 1994 | A |
5320644 | Baumgartner | Jun 1994 | A |
5342393 | Stack | Aug 1994 | A |
5342394 | Matsuno et al. | Aug 1994 | A |
5356432 | Rutkow et al. | Oct 1994 | A |
5366460 | Eberbach | Nov 1994 | A |
5368602 | de la Torre | Nov 1994 | A |
5370660 | Weinstein et al. | Dec 1994 | A |
5370697 | Baumgartner | Dec 1994 | A |
5376693 | Viegas et al. | Dec 1994 | A |
5383477 | DeMatteis | Jan 1995 | A |
5383905 | Golds et al. | Jan 1995 | A |
5390683 | Pisharodi | Feb 1995 | A |
5397331 | Himpens et al. | Mar 1995 | A |
5397332 | Kammerer et al. | Mar 1995 | A |
5405360 | Tovey | Apr 1995 | A |
5425772 | Brantigan | Jun 1995 | A |
5425773 | Boyd et al. | Jun 1995 | A |
5437631 | Janzen | Aug 1995 | A |
5456720 | Schultz et al. | Oct 1995 | A |
5464407 | McGuire | Nov 1995 | A |
5500000 | Feagin et al. | Mar 1996 | A |
5507754 | Green et al. | Apr 1996 | A |
5514180 | Heggeness et al. | May 1996 | A |
5520700 | Beyar et al. | May 1996 | A |
5531759 | Kensey et al. | Jul 1996 | A |
5534028 | Bao et al. | Jul 1996 | A |
5534030 | Navarro et al. | Jul 1996 | A |
5540715 | Katsaros et al. | Jul 1996 | A |
5545178 | Kensey et al. | Aug 1996 | A |
5545229 | Parsons et al. | Aug 1996 | A |
5549579 | Kuslich | Aug 1996 | A |
5549617 | Green et al. | Aug 1996 | A |
5556428 | Shah | Sep 1996 | A |
5556429 | Felt | Sep 1996 | A |
5562680 | Green et al. | Oct 1996 | A |
5562736 | Ray et al. | Oct 1996 | A |
5562738 | Boyd et al. | Oct 1996 | A |
5569252 | Justin et al. | Oct 1996 | A |
5571189 | Kuslich | Nov 1996 | A |
5582616 | Boldue et al. | Dec 1996 | A |
5587175 | Viegas et al. | Dec 1996 | A |
5591223 | Lock et al. | Jan 1997 | A |
5613974 | Andreas et al. | Mar 1997 | A |
5620012 | Benderev et al. | Apr 1997 | A |
5624463 | Stone et al. | Apr 1997 | A |
5626613 | Schmieding | May 1997 | A |
5634931 | Kugel | Jun 1997 | A |
5645084 | McKay | Jul 1997 | A |
5645597 | Krapiva | Jul 1997 | A |
5658343 | Hauselmann et al. | Aug 1997 | A |
5662683 | Kay | Sep 1997 | A |
5669935 | Rosenman et al. | Sep 1997 | A |
5674294 | Bainville et al. | Oct 1997 | A |
5674296 | Bryan et al. | Oct 1997 | A |
5676698 | Janzen et al. | Oct 1997 | A |
5676701 | Yuan et al. | Oct 1997 | A |
5681310 | Yuan et al. | Oct 1997 | A |
5681351 | Jamiolkowski et al. | Oct 1997 | A |
5683465 | Shinn et al. | Nov 1997 | A |
5690674 | Diaz | Nov 1997 | A |
5695525 | Mulhauser et al. | Dec 1997 | A |
5702450 | Bisserie | Dec 1997 | A |
5702451 | Biedermann et al. | Dec 1997 | A |
5702454 | Baumgartner | Dec 1997 | A |
5702462 | Oberlander | Dec 1997 | A |
5709854 | Griffith-Cima et al. | Jan 1998 | A |
5716408 | Eldridge et al. | Feb 1998 | A |
5716409 | Debbas | Feb 1998 | A |
5716413 | Walter et al. | Feb 1998 | A |
5716416 | Lin | Feb 1998 | A |
5718862 | Thompson | Feb 1998 | A |
5725577 | Saxon | Mar 1998 | A |
5728150 | McDonald et al. | Mar 1998 | A |
5730744 | Justin et al. | Mar 1998 | A |
5733337 | Car, Jr. et al. | Mar 1998 | A |
5743917 | Saxon | Apr 1998 | A |
5746755 | Wood et al. | May 1998 | A |
5746765 | Rabkin | May 1998 | A |
5766246 | Mulhauser et al. | Jun 1998 | A |
5769864 | Kugel | Jun 1998 | A |
5769893 | Shah | Jun 1998 | A |
5772661 | Michelson | Jun 1998 | A |
5776183 | Kanesaka et al. | Jul 1998 | A |
5782844 | Yoon et al. | Jul 1998 | A |
5785705 | Baker | Jul 1998 | A |
5800549 | Bao et al. | Sep 1998 | A |
5800550 | Sertich | Sep 1998 | A |
5801033 | Hubbell et al. | Sep 1998 | A |
5810851 | Yoon | Sep 1998 | A |
5823994 | Sharkey et al. | Oct 1998 | A |
5824008 | Bolduc et al. | Oct 1998 | A |
5824082 | Brown | Oct 1998 | A |
5824093 | Ray et al. | Oct 1998 | A |
5824094 | Serhan et al. | Oct 1998 | A |
5827298 | Hart et al. | Oct 1998 | A |
5827328 | Butterman | Oct 1998 | A |
5836315 | Benderev et al. | Nov 1998 | A |
5843084 | Hart et al. | Dec 1998 | A |
5846261 | Kotula | Dec 1998 | A |
5860425 | Benderev et al. | Jan 1999 | A |
5860977 | Zucherman et al. | Jan 1999 | A |
5865845 | Thalgott | Feb 1999 | A |
5865846 | Bryan et al. | Feb 1999 | A |
5879366 | Shaw et al. | Mar 1999 | A |
5888220 | Felt et al. | Mar 1999 | A |
5888226 | Rogozinski | Mar 1999 | A |
5893889 | Harrington | Apr 1999 | A |
5916225 | Kugel | Jun 1999 | A |
5919235 | Husson et al. | Jul 1999 | A |
5922026 | Chin | Jul 1999 | A |
5928284 | Mehdizadeh | Jul 1999 | A |
5935147 | Kensey et al. | Aug 1999 | A |
5954716 | Sharkey et al. | Sep 1999 | A |
5954767 | Pajotin et al. | Sep 1999 | A |
5957939 | Heaven et al. | Sep 1999 | A |
5972000 | Beyar et al. | Oct 1999 | A |
5972007 | Sheffield et al. | Oct 1999 | A |
5972022 | Huxel | Oct 1999 | A |
5976174 | Ruiz | Nov 1999 | A |
5976186 | Bao et al. | Nov 1999 | A |
5980504 | Sharkey et al. | Nov 1999 | A |
6001130 | Bryan et al. | Dec 1999 | A |
6007570 | Sharkey et al. | Dec 1999 | A |
6007575 | Samuels | Dec 1999 | A |
6019793 | Perren et al. | Feb 2000 | A |
6024754 | Engelson | Feb 2000 | A |
6027527 | Asano et al. | Feb 2000 | A |
6126682 | Sharkey et al. | Oct 2000 | A |
6140452 | Felt et al. | Oct 2000 | A |
6146380 | Racz et al. | Nov 2000 | A |
6180848 | Flament et al. | Jan 2001 | B1 |
6183518 | Ross et al. | Feb 2001 | B1 |
6206921 | Guagliano et al. | Mar 2001 | B1 |
6224630 | Bao et al. | May 2001 | B1 |
6245107 | Ferree | Jun 2001 | B1 |
6371990 | Ferree | Apr 2002 | B1 |
6402750 | Atkinson et al. | Jun 2002 | B1 |
6428576 | Haldimann | Aug 2002 | B1 |
6436143 | Ross et al. | Aug 2002 | B1 |
6482235 | Lambrecht et al. | Nov 2002 | B1 |
20020198599 | Haldimann | Dec 2002 | A1 |
Number | Date | Country |
---|---|---|
0 700 671 | Mar 1966 | EP |
0 277 678 | Aug 1988 | EP |
0 722 700 | Dec 1998 | EP |
1180978 | May 2005 | EP |
2639823 | Jun 1990 | FR |
WO9531946 | Nov 1995 | WO |
WO9534331 | Dec 1995 | WO |
WO9726847 | Jul 1997 | WO |
9730638 | Aug 1997 | WO |
9817190 | Apr 1998 | WO |
WO9820939 | May 1998 | WO |
9834552 | Aug 1998 | WO |
9900074 | Jan 1999 | WO |
9902214 | Jan 1999 | WO |
9903422 | Jan 1999 | WO |
WO9902108 | Jan 1999 | WO |
9930651 | Jun 1999 | WO |
9947058 | Sep 1999 | WO |
9961084 | Dec 1999 | WO |
9962439 | Dec 1999 | WO |
WO9961840 | Dec 1999 | WO |
0042953 | Jul 2000 | WO |
0062832 | Oct 2000 | WO |
0110316 | Feb 2001 | WO |
0110318 | Feb 2001 | WO |
0121246 | Mar 2001 | WO |
0128464 | Apr 2001 | WO |
0145577 | Jun 2001 | WO |
Number | Date | Country | |
---|---|---|---|
20040097980 A1 | May 2004 | US |
Number | Date | Country | |
---|---|---|---|
60148913 | Aug 1999 | US |
Number | Date | Country | |
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Parent | 09638241 | Aug 2000 | US |
Child | 10630445 | US |
Number | Date | Country | |
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Parent | PCT/US00/14708 | May 2000 | US |
Child | 09638241 | US | |
Parent | 09322516 | May 1999 | US |
Child | PCT/US00/14708 | US |