The present invention relates to implants and methods for accessing and operating on the lumbosacral spine.
The spinal column is a highly complex system of bones and connective tissues that provide support for the body and protect the delicate spinal cord and nerves. The spinal column includes a series of vertebral bodies stacked one atop the other, each vertebral body including an inner or central portion of relatively weak cancellous bone and an outer portion of relatively strong cortical bone. Situated between each vertebral body is an intervertebral disc that cushions and dampens compressive forces exerted upon the spinal column. A vertebral canal containing the spinal cord is located behind the vertebral bodies.
There are many types of spinal column disorders including scoliosis (abnormal lateral curvature of the spine), excess kyphosis (abnormal forward curvature of the spine), excess lordosis (abnormal backward curvature of the spine), spondylolisthesis (forward displacement of one vertebra over another), and other disorders caused by abnormalities, disease or trauma, such as ruptured or slipped discs, degenerative disc disease, fractured vertebra and the like. Patients that suffer from such conditions usually experience extreme and debilitating pain, as well as diminished nerve function.
A noteworthy trend in the medical community is the move away from performing surgery via traditional “open” techniques in favor of minimally invasive or minimal access techniques. Open surgical techniques are generally undesirable in that they typically require large incisions and high amounts of tissue displacement to gain access to the surgical target site, which produces concomitantly high amounts of pain, lengthened hospitalization (increasing health care costs), and high morbidity in the patient population. Less-invasive surgical techniques (including so-called “minimal access” and “minimally invasive” techniques) are gaining favor due to the fact that they involve accessing the surgical target site via incisions of substantially smaller size with greatly reduced tissue displacement requirements. This, in turn, reduces the pain, morbidity and cost associated with such procedures. On such minimally invasive approach, a lateral trans-psoas approach to the spine, developed by NuVasive®, Inc., San Diego, Calif. (XLIF®) has demonstrated great success in reducing patient morbidity, shortening hospitalization stays and quickening recovery time if it is employed.
Unfortunately, the iliac crest blocks lateral access to the L5/S1 disc space in most individuals, leaving only anterior and posterior approaches available to reach the L5/S1 disc. Thus, in a patient requiring a multi-level operation including L5-S1, for example, a lateral trans-psoas approach may be utilized to treat the spinal condition at one or more levels above the L5/S1 disc, and the patient may be moved into a new position to access the L5/S1 disc through either the anterior or posterior approach. The systems and methods described herein are directed towards eliminating, or at least reducing, these challenges.
The present invention is directed at overcoming, or at least improving upon, the disadvantages of the prior art.
Access to the L5/S1 disc space (also referred to as the 5-1 disc) may be achieved laterally through the iliac crest. One or more instruments are used to create an access hole through the iliac over the L5/S1 disc. Through the access hole one or more instruments may be advanced to the L5/S1 disc, taking care to avoid damaging delicate nerves and blood vessels situated in the space between the iliac crest and spinal column. One of the one or more instruments advanced to the disc space may be a working portal through which the disc may be operated on (e.g. discectomy and fusion may be performed).
The precise size and location of the safe zone may vary from patient to patient, thus it is important to assess the safe zone prior to creating the access corridor. The safe zone may be assessed through pre-operatively through the study of pre-operative images (e.g. CT scans and/or MRI). The L5 nerve root and the iliac vein (and artery) can be identified in the images and the size of the safe zone determined. By way of example, the size of the safe zone may generally vary between a range of approximately 10 mm and 20 mm, though the range is not inclusive.
Once the safe zone has been assessed during pre-operative planning, the information may be used during surgery to avoid the iliac vessels and the L5 nerve root. This is accomplished by using nerve monitoring techniques to locate the L5 nerve root. By way of example, stimulation signals are emitted from the distal end of an access instrument (e.g. dilator) and muscles innervated by the nerve are monitored for a neuromuscular response. The stimulation current level required to elicit a significant response (stimulation threshold) is determined, and preferably repeatedly updated, which provides an indication of the nerve proximity (and optionally, direction) to the distal end of the access instrument. The higher the stimulation threshold the farther away the nerve is, and vice versa. Thus, to seek out the L5 nerve root the user can direct the access instrument such that the stimulation threshold gets lower and lower (indicating that the access instrument is getting closer to the nerve) until the threshold drops below a certain level (e.g. 3 mA) indicating that the instrument is right next to the nerve, but not contacting the nerve. Directionality may be determined to ensure that the instrument is anterior to the nerve. With the position of the nerve now know, the position of the iliac vein is also known (based on the pre-operative planning data) and the access instrument may be docked to the 5-1 disc in the safe zone. By following the path of the initial access instrument, additional instruments can safely advance through to the L5/S1 disc and the desired procedure may be completed on the disc. Nerve monitoring may be conducted with one or more of the additional instruments.
As described herein, two sets of dilators are used to create the access corridor to the 5-1 disc. The first set of dilators is used for dilating the iliac crest and the dilators are designed to be impacted through the iliac bone. The second set of dilators are used for dilating through the iliac space and are designed to be used with a neurophysiology monitoring system to determine the location of the L5 nerve root as the dilators are advanced. It should be appreciated that two different sets of dilators are not necessarily required, provided that the both functions (i.e. impaction through bone and nerve monitoring) may be completed with the dilators chosen.
According to the example method described, a jamshidi is first advanced into the iliac bone at the appropriate entry point. The needle of the jamshidi is removed and a K-wire or similar guide is advanced into the iliac. The cannula of the jamshidi is removed and the initial dilator of the first dilator set (impaction dilators) is advanced into the iliac crest, over the K-wire, and wagged around. The supplemental dilators of the first dilator set are the advanced in turn into the iliac bone until the access hole created is of the appropriate size. The dilators are then removed and the initial dilator of the second dilator set (electrified dilators) is advanced to the access hole. The initial dilator is connected to the neurophysiology monitoring system to perform nerve detection as described above and the dilator is advanced toward the L5 nerve root. Once the nerve root is located the initial dilator is docked in the desired position on the 5-1 disc with the K-wire. The supplemental dilators of the second set of dilators are then advanced in turn through the safe zone onto the disc space until the desired size is achieved. The outer dilator is fixed in position (e.g. by penetrating into the disc or vertebral body, or, with a table mount) and the inner dilators are removed.
The inner lumen of the outer dilator becomes a working portal through which instruments may be passed to perform the desired procedure on the L5/S1 disc. For example, the instruments may be curettes, reamers, shavers, etc. . . . for performing a discectomy. Implants may also be deposited in the disc space to facilitate fusion. The implant may be a collapsible bag that is advanced through the working corridor in a collapsed configuration and then filled with a filler material in situ. The filler material may be a bone growth promoting material (e.g. bone chips, synthetic or cellular bone matrix, etc. . . . ). The implant may also be an expandable implant that is implanted into the disc space in a first smaller configuration and then expanded via any number of suitable expansion mechanisms. The implant may also be a modular implant that is inserted through the working portal in several smaller pieces and assembled in the disc space to form a larger implant. Bone growth promoting material may be packed in or around any of the implants described. Once work on the 5-1 disc is complete, the working portal is removed and the wound closed.
Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The methods and devices described herein include a variety of inventive features and components that warrant patent protection, both individually and in combination.
As described hereafter, access to the L5/S1 disc space is achieved laterally through the ilium. One or more instruments are used to create an access hole through the ilium over top of the L5/S1 disc. Through the access hole one or more instruments may be advanced to the L5/S1 disc, taking care to avoid damaging delicate nerves and blood vessels situated in the space between the iliac crest and spinal column. One of the one or more instruments advanced to the disc space may form a working portal through which the disc may be operated on, for example, a discectomy and fusion may be performed.
Prior to describing the trans-iliac method for access the L5/S1 disc, the relevant anatomy, including the iliac crest 10, L5/S1 disc 12, and the space that separates them—referred to herein as the iliac space 14, are described with reference to
The size and precise layout of the safe zone 26 varies from patient to patient. For example, though not limited to it, the size of the safe zone (i.e. distance between the L5 nerve root 16 and iliac vein 18) may generally range from approximately 10 mm to 20 mm. Accordingly, it is preferable that the safe zone be identified and assessed during pre-operative planning. This is accomplished through the review of CT and/or MRI images on which the L5 nerve root 16 and the iliac vein 18 can be identified and the distance between them measured. This information will then be used later during the procedure to ensure the access instrument(s) stay within the safe zone during passage through the iliac space 14.
According to the example method described herein, L5/S1 access is achieved using a jamshidi type needle, K-wire, and two sets of dilators. With reference to
The second dilator set 48, illustrated in
With reference to
With the K-wire 46 (or other guide member) in place, the initial dilator 42 of the first dilator set 40 (impaction dilators) is advanced into the pilot hole, over the K-wire, as depicted in
Turning to
To ensure the second dilator set 48 is passed through the safe zone, the surgeon first directs the initial dilator 50 towards the L5 nerve root 16, which marks the posterior border of the safe zone. To seek out the L5 nerve root 16 the surgeon advances the initial dilator 50 such that the stimulation threshold gets lower and lower (indicating that the dilator is getting closer to the nerve root) until the threshold drops below a certain level, for example, 3 mA. When the stimulation threshold drops to this predetermined level, the surgeon knows that the distal end of the dilator 50 is indicating that the instrument is next to, but not contacting the nerve root 16. The goal at this stage is to position the dilator 50 right next to the nerve root 16 without injuring the root and keeping the dilator 50 anterior to the nerve root. Directionality may be determined (for example, by rotating the dilator to determine the direction that gives the lowest stimulation threshold) to ensure that the instrument is anterior to the nerve. With the location of the L5 nerve root 16 now known, the position of the iliac vein 18 is also known based on the information gained from the preoperative pre-operative planning. That is, the distance between the nerve root 16 and the iliac vein 18 is determined during pre-operative planning such that with the dilator 50 positioned right next to the nerve root 16, the surgeon knows how much room there is to work anterior to the nerve root 16 before encroaching on the iliac vein 18 (and iliac artery 20). Using this information, the initial dilator 50 is adjusted anteriorly into the safe zone to provide room relative to the L5 nerve root 16 for advancement of the supplemental dilator(s) 52, and is then docked on the L5/S1 disc 12 with a k-wire 46 to hold the position of the second dilator set 48 (
As illustrated in
With reference to
As evident from the above discussion and drawings, the apparatus and methods described accomplish the goals of gaining access to the 5/1 disc space in a fashion less invasive than traditional “open” surgeries, while still achieving significant disc preparation. And while the apparatus and methods have been described in terms of a best mode for achieving these objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the invention.
This application is an non-provisional patent application and claims the benefit of priority from U.S. Provisional Patent Application Ser. No. 61/471,069, entitled “Systems and Methods for Performing Spine Surgery,” filed on Apr. 1, 2011, the entire contents of which is expressly incorporated by reference into this disclosure as if set forth in its entirety herein.
Number | Name | Date | Kind |
---|---|---|---|
208227 | Dorr | Sep 1878 | A |
972983 | Arthur | Oct 1910 | A |
1003232 | Cerbo | Oct 1910 | A |
1044348 | Cerbo | Jun 1912 | A |
1328624 | Graham | Jan 1920 | A |
1548184 | Cameron | Aug 1925 | A |
2594086 | Smith | Apr 1952 | A |
2704064 | Fizzell et al. | Mar 1955 | A |
2736002 | Oriel | Feb 1956 | A |
2808826 | Reiner et al. | Oct 1957 | A |
3364929 | Ide et al. | Jan 1968 | A |
3664329 | Naylor | May 1972 | A |
3682162 | Colyer | Aug 1972 | A |
3785368 | McCarthy et al. | Jan 1974 | A |
3803716 | Garnier | Apr 1974 | A |
3830226 | Staub et al. | Aug 1974 | A |
3957036 | Normann | May 1976 | A |
D245789 | Shea et al. | Sep 1977 | S |
4099519 | Warren | Jul 1978 | A |
4164214 | Stark et al. | Aug 1979 | A |
4207897 | Lloyd et al. | Jun 1980 | A |
4224949 | Scott et al. | Sep 1980 | A |
4226228 | Shin et al. | Oct 1980 | A |
4226288 | Collins, Jr. | Oct 1980 | A |
4235242 | Howson et al. | Nov 1980 | A |
4285347 | Hess | Aug 1981 | A |
4291705 | Severinghaus et al. | Sep 1981 | A |
4449532 | Storz | May 1984 | A |
4461300 | Christensen | Jul 1984 | A |
4512351 | Pohndorf | Apr 1985 | A |
4515168 | Chester et al. | May 1985 | A |
4519403 | Dickhudt | May 1985 | A |
4545374 | Jacobson | Oct 1985 | A |
4561445 | Berke et al. | Dec 1985 | A |
4562832 | Wilder et al. | Jan 1986 | A |
4573448 | Kambin | Mar 1986 | A |
4592369 | Davis et al. | Jun 1986 | A |
4595013 | Jones et al. | Jun 1986 | A |
4595018 | Rantala | Jun 1986 | A |
4611597 | Kraus | Sep 1986 | A |
4616635 | Caspar et al. | Oct 1986 | A |
4633889 | Talalla | Jan 1987 | A |
4658835 | Pohndorf | Apr 1987 | A |
D295445 | Freeman | Apr 1988 | S |
4744371 | Harris | May 1988 | A |
4753223 | Bremer | Jun 1988 | A |
4759377 | Dykstra | Jul 1988 | A |
4784150 | Voorhies et al. | Nov 1988 | A |
4807642 | Brown | Feb 1989 | A |
D300561 | Asa et al. | Apr 1989 | S |
4892105 | Prass | Jan 1990 | A |
4913134 | Luque | Apr 1990 | A |
4917274 | Asa et al. | Apr 1990 | A |
4917704 | Frey et al. | Apr 1990 | A |
4926865 | Oman | May 1990 | A |
4950257 | Hibbs et al. | Aug 1990 | A |
4962766 | Herzon | Oct 1990 | A |
4964411 | Johnson et al. | Oct 1990 | A |
5007902 | Witt | Apr 1991 | A |
5015247 | Michelson | May 1991 | A |
5045054 | Hood et al. | Sep 1991 | A |
5052373 | Michelson | Oct 1991 | A |
5058602 | Brody | Oct 1991 | A |
5081990 | Deletis | Jan 1992 | A |
5092344 | Lee | Mar 1992 | A |
5127403 | Brownlee | Jul 1992 | A |
5161533 | Prass et al. | Nov 1992 | A |
5171279 | Mathews | Dec 1992 | A |
5192327 | Brantigan | Mar 1993 | A |
5195541 | Obenchain | Mar 1993 | A |
5196015 | Neubardt | Mar 1993 | A |
5215100 | Spitz et al. | Jun 1993 | A |
RE34390 | Culver | Sep 1993 | E |
D340521 | Heinzelman et al. | Oct 1993 | S |
5255691 | Otten | Oct 1993 | A |
5282468 | Klepinski | Feb 1994 | A |
5284153 | Raymond et al. | Feb 1994 | A |
5284154 | Raymond et al. | Feb 1994 | A |
5295994 | Bonutti | Mar 1994 | A |
5299563 | Seton | Apr 1994 | A |
5312417 | Wilk | May 1994 | A |
5313956 | Knutsson et al. | May 1994 | A |
5313962 | Obenchain | May 1994 | A |
5327902 | Lemmen | Jul 1994 | A |
5331975 | Bonutti | Jul 1994 | A |
5333618 | Lekhtman et al. | Aug 1994 | A |
5342384 | Sugarbaker | Aug 1994 | A |
5357983 | Mathews | Oct 1994 | A |
5375067 | Berchin | Dec 1994 | A |
5375594 | Cueva | Dec 1994 | A |
5383876 | Nardella | Jan 1995 | A |
5395317 | Kambin | Mar 1995 | A |
5450845 | Axelgaard | Sep 1995 | A |
5472426 | Bonati et al. | Dec 1995 | A |
5474057 | Makower et al. | Dec 1995 | A |
5474558 | Neubardt | Dec 1995 | A |
5480440 | Kambin | Jan 1996 | A |
5482038 | Ruff | Jan 1996 | A |
5484437 | Michelson | Jan 1996 | A |
5487739 | Aebischer et al. | Jan 1996 | A |
5509893 | Pracas | Apr 1996 | A |
5514153 | Bonutti | May 1996 | A |
5540235 | Wilson | Jul 1996 | A |
5549656 | Reiss | Aug 1996 | A |
5560372 | Cory | Oct 1996 | A |
5566678 | Cadwell | Oct 1996 | A |
5569290 | McAfee | Oct 1996 | A |
5571149 | Liss et al. | Nov 1996 | A |
5579781 | Cooke | Dec 1996 | A |
5593429 | Ruff | Jan 1997 | A |
5599279 | Slotman et al. | Feb 1997 | A |
5630813 | Kieturakis | May 1997 | A |
5667508 | Errico et al. | Sep 1997 | A |
5671752 | Sinderby et al. | Sep 1997 | A |
5681265 | Maeda et al. | Oct 1997 | A |
5688223 | Rosendahl | Nov 1997 | A |
5707359 | Bufalini | Jan 1998 | A |
5711307 | Smits | Jan 1998 | A |
5728046 | Mayer et al. | Mar 1998 | A |
5741253 | Michelson | Apr 1998 | A |
5741261 | Moskovitz et al. | Apr 1998 | A |
5759159 | Masreliez | Jun 1998 | A |
5762629 | Kambin | Jun 1998 | A |
5772661 | Michelson | Jun 1998 | A |
5775331 | Raymond et al. | Jul 1998 | A |
5776144 | Leysieffer et al. | Jul 1998 | A |
5779642 | Nightengale | Jul 1998 | A |
5785658 | Benaron | Jul 1998 | A |
5792044 | Foley et al. | Aug 1998 | A |
5797854 | Hedgecock | Aug 1998 | A |
5797909 | Michelson | Aug 1998 | A |
5814073 | Bonutti | Sep 1998 | A |
5830151 | Hadzic et al. | Nov 1998 | A |
5851191 | Gozani | Dec 1998 | A |
5853373 | Griffith et al. | Dec 1998 | A |
5860973 | Michelson | Jan 1999 | A |
5862314 | Jeddeloh | Jan 1999 | A |
5872314 | Clinton | Feb 1999 | A |
5885210 | Cox | Mar 1999 | A |
5885219 | Nightengale | Mar 1999 | A |
5888196 | Bonutti | Mar 1999 | A |
5891147 | Moskovitz et al. | Apr 1999 | A |
5902231 | Foley et al. | May 1999 | A |
5928139 | Koros et al. | Jul 1999 | A |
5928158 | Aristides | Jul 1999 | A |
5931777 | Sava | Aug 1999 | A |
5935131 | Bonutti et al. | Aug 1999 | A |
5938688 | Schiff | Aug 1999 | A |
5944658 | Koros et al. | Aug 1999 | A |
5976094 | Gozani et al. | Nov 1999 | A |
6004262 | Putz et al. | Dec 1999 | A |
6004312 | Finneran | Dec 1999 | A |
6007487 | Foley et al. | Dec 1999 | A |
6010520 | Pattison | Jan 2000 | A |
6024696 | Hoftman et al. | Feb 2000 | A |
6024697 | Pisarik | Feb 2000 | A |
6027456 | Feler et al. | Feb 2000 | A |
6038469 | Karlsson et al. | Mar 2000 | A |
6038477 | Kayyali | Mar 2000 | A |
6050992 | Nichols | Apr 2000 | A |
6074343 | Nathanson et al. | Jun 2000 | A |
6083154 | Liu et al. | Jul 2000 | A |
6095987 | Shmulewitz | Aug 2000 | A |
6104957 | Alo et al. | Aug 2000 | A |
6104960 | Duysens et al. | Aug 2000 | A |
6120503 | Michelson | Sep 2000 | A |
6126660 | Dietz | Oct 2000 | A |
6132386 | Gozani et al. | Oct 2000 | A |
6132387 | Gozani et al. | Oct 2000 | A |
6135965 | Tumer et al. | Oct 2000 | A |
6139493 | Koros et al. | Oct 2000 | A |
6146335 | Gozani | Nov 2000 | A |
6152871 | Foley et al. | Nov 2000 | A |
6159179 | Simonson | Dec 2000 | A |
6161047 | King et al. | Dec 2000 | A |
6174311 | Branch et al. | Jan 2001 | B1 |
6181961 | Prass | Jan 2001 | B1 |
6196969 | Bester et al. | Mar 2001 | B1 |
6206826 | Mathews et al. | Mar 2001 | B1 |
6217509 | Foley et al. | Apr 2001 | B1 |
6224549 | Drongelen | May 2001 | B1 |
6245082 | Gellman et al. | Jun 2001 | B1 |
6259945 | Epstein et al. | Jul 2001 | B1 |
6264651 | Underwood et al. | Jul 2001 | B1 |
6266558 | Gozani et al. | Jul 2001 | B1 |
6273905 | Streeter | Aug 2001 | B1 |
6292701 | Prass et al. | Sep 2001 | B1 |
6306100 | Prass | Oct 2001 | B1 |
6308712 | Shaw | Oct 2001 | B1 |
6312392 | Herzon | Nov 2001 | B1 |
6325764 | Griffith et al. | Dec 2001 | B1 |
6334068 | Hacker | Dec 2001 | B1 |
6348058 | Melkent et al. | Feb 2002 | B1 |
6360750 | Gerber et al. | Mar 2002 | B1 |
6371968 | Kogasaka et al. | Apr 2002 | B1 |
6395007 | Bhatnagar et al. | May 2002 | B1 |
6425859 | Foley et al. | Jul 2002 | B1 |
6425887 | McGuckin et al. | Jul 2002 | B1 |
6425901 | Zhu et al. | Jul 2002 | B1 |
6450952 | Rioux et al. | Sep 2002 | B1 |
6451015 | Rittman, III et al. | Sep 2002 | B1 |
6466817 | Kaula et al. | Oct 2002 | B1 |
6468205 | Mollenauer et al. | Oct 2002 | B1 |
6468207 | Fowler, Jr. | Oct 2002 | B1 |
6500116 | Knapp | Dec 2002 | B1 |
6500128 | Marino | Dec 2002 | B2 |
6520907 | Foley et al. | Feb 2003 | B1 |
6524320 | DiPoto | Feb 2003 | B2 |
6535759 | Epstein et al. | Mar 2003 | B1 |
6564078 | Marino et al. | May 2003 | B1 |
6579244 | Goodwin | Jun 2003 | B2 |
6599294 | Fuss et al. | Jul 2003 | B2 |
6620157 | Dabney et al. | Sep 2003 | B1 |
6645194 | Briscoe et al. | Nov 2003 | B2 |
6679833 | Smith et al. | Jan 2004 | B2 |
6719692 | Kleffner et al. | Apr 2004 | B2 |
6760616 | Hoey et al. | Jul 2004 | B2 |
6770074 | Michelson | Aug 2004 | B2 |
6796985 | Bolger et al. | Sep 2004 | B2 |
6810281 | Brock et al. | Oct 2004 | B2 |
6819956 | DiLorenzo | Nov 2004 | B2 |
6829508 | Schulman et al. | Dec 2004 | B2 |
6847849 | Mamo et al. | Jan 2005 | B2 |
6849047 | Goodwin | Feb 2005 | B2 |
6855105 | Jackson, III et al. | Feb 2005 | B2 |
6869398 | Obenchain | Mar 2005 | B2 |
6871099 | Whitehurst et al. | Mar 2005 | B1 |
6902569 | Parmer et al. | Jun 2005 | B2 |
6916330 | Simonson | Jul 2005 | B2 |
6926728 | Zucherman et al. | Aug 2005 | B2 |
6929606 | Ritland | Aug 2005 | B2 |
6945933 | Branch | Sep 2005 | B2 |
6951538 | Ritland | Oct 2005 | B2 |
7047082 | Schrom et al. | May 2006 | B1 |
7050848 | Hoey et al. | May 2006 | B2 |
7079883 | Marino et al. | Jul 2006 | B2 |
7089059 | Pless | Aug 2006 | B1 |
7177677 | Kaula et al. | Feb 2007 | B2 |
7198598 | Smith et al. | Apr 2007 | B2 |
7207949 | Miles et al. | Apr 2007 | B2 |
7226451 | Shluzas et al. | Jun 2007 | B2 |
7261688 | Smith et al. | Aug 2007 | B2 |
7326216 | Bertagnoli et al. | Feb 2008 | B2 |
7470236 | Kelleher et al. | Dec 2008 | B1 |
7473222 | Dewey et al. | Jan 2009 | B2 |
7481766 | Lee et al. | Jan 2009 | B2 |
7522953 | Kaula et al. | Apr 2009 | B2 |
7556601 | Branch et al. | Jul 2009 | B2 |
7582058 | Miles et al. | Sep 2009 | B1 |
7643884 | Pond et al. | Jan 2010 | B2 |
7691057 | Miles et al. | Apr 2010 | B2 |
7693562 | Marino et al. | Apr 2010 | B2 |
7717959 | William et al. | May 2010 | B2 |
7819801 | Miles et al. | Oct 2010 | B2 |
7935051 | Miles et al. | May 2011 | B2 |
8000782 | Gharib et al. | Aug 2011 | B2 |
8005535 | Gharib et al. | Aug 2011 | B2 |
8021430 | Michelson | Sep 2011 | B2 |
8133173 | Miles et al. | Mar 2012 | B2 |
8192356 | Miles et al. | Jun 2012 | B2 |
8244343 | Gharib et al. | Aug 2012 | B2 |
8245570 | Pickl et al. | Aug 2012 | B2 |
8251997 | Michelson | Aug 2012 | B2 |
8303458 | Fukano et al. | Nov 2012 | B2 |
8343046 | Miles et al. | Jan 2013 | B2 |
8343224 | Lynn et al. | Jan 2013 | B2 |
8388527 | Miles | Mar 2013 | B2 |
8439925 | Marino et al. | May 2013 | B2 |
20010039949 | Loubser | Nov 2001 | A1 |
20010056280 | Underwood et al. | Dec 2001 | A1 |
20020007129 | Marino | Jan 2002 | A1 |
20020010392 | Desai | Jan 2002 | A1 |
20020072686 | Hoey et al. | Jun 2002 | A1 |
20020077632 | Tsou | Jun 2002 | A1 |
20020123744 | Reynard | Sep 2002 | A1 |
20020123780 | Grill et al. | Sep 2002 | A1 |
20020161415 | Cohen et al. | Oct 2002 | A1 |
20020193843 | Hill et al. | Dec 2002 | A1 |
20030032966 | Foley et al. | Feb 2003 | A1 |
20030070682 | Wilson et al. | Apr 2003 | A1 |
20030083688 | Simonson | May 2003 | A1 |
20030105503 | Marino | Jun 2003 | A1 |
20030139648 | Foley et al. | Jul 2003 | A1 |
20030149341 | Clifton | Aug 2003 | A1 |
20030225405 | Weiner | Dec 2003 | A1 |
20030236544 | Lunsford et al. | Dec 2003 | A1 |
20040199084 | Kelleher et al. | Oct 2004 | A1 |
20040225228 | Ferree | Nov 2004 | A1 |
20050004593 | Simonson | Jan 2005 | A1 |
20050004623 | Miles et al. | Jan 2005 | A1 |
20050033380 | Tanner et al. | Feb 2005 | A1 |
20050075578 | Gharib et al. | Apr 2005 | A1 |
20050080320 | Lee et al. | Apr 2005 | A1 |
20050149035 | Pimenta et al. | Jul 2005 | A1 |
20050182454 | Gharib et al. | Aug 2005 | A1 |
20050192575 | Pacheco | Sep 2005 | A1 |
20060025703 | Miles et al. | Feb 2006 | A1 |
20060052828 | Kim et al. | Mar 2006 | A1 |
20060069315 | Miles et al. | Mar 2006 | A1 |
20060224078 | Hoey et al. | Oct 2006 | A1 |
20070016097 | Farquhar et al. | Jan 2007 | A1 |
20070198062 | Miles et al. | Aug 2007 | A1 |
20070293782 | Marino | Dec 2007 | A1 |
20080058606 | Miles et al. | Mar 2008 | A1 |
20080058838 | Steinberg | Mar 2008 | A1 |
20080064976 | Kelleher et al. | Mar 2008 | A1 |
20080064977 | Kelleher et al. | Mar 2008 | A1 |
20080065178 | Kelleher et al. | Mar 2008 | A1 |
20080071191 | Kelleher et al. | Mar 2008 | A1 |
20080097164 | Miles et al. | Apr 2008 | A1 |
20080300465 | Feigenwinter et al. | Dec 2008 | A1 |
20090124860 | Miles et al. | May 2009 | A1 |
20090138050 | Ferree | May 2009 | A1 |
20090192403 | Gharib et al. | Jul 2009 | A1 |
20090204016 | Gharib et al. | Aug 2009 | A1 |
20100069783 | Miles et al. | Mar 2010 | A1 |
20100130827 | Pimenta et al. | May 2010 | A1 |
20100152603 | Miles et al. | Jun 2010 | A1 |
20100160738 | Miles et al. | Jun 2010 | A1 |
20100174146 | Miles | Jul 2010 | A1 |
20100174148 | Miles et al. | Jul 2010 | A1 |
20120010472 | Spann | Jan 2012 | A1 |
20120238822 | Miles | Sep 2012 | A1 |
Number | Date | Country |
---|---|---|
299 08 259 | Jul 1999 | DE |
100 48 790 | Apr 2002 | DE |
0 972 538 | Jan 2000 | EA |
0 334 116 | Sep 1989 | EP |
1 002 500 | May 2000 | EP |
2 795 624 | Jan 2001 | FR |
793186 | May 1990 | JP |
10-14928 | Mar 1996 | JP |
3019990007098 | Nov 1999 | KR |
0 567 424 | Oct 1993 | WO |
9428824 | Dec 1994 | WO |
9700702 | Jan 1997 | WO |
9823324 | Jun 1998 | WO |
9952446 | Oct 1999 | WO |
0027291 | May 2000 | WO |
0038574 | Jul 2000 | WO |
0044288 | Aug 2000 | WO |
0066217 | Nov 2000 | WO |
0067645 | Nov 2000 | WO |
0108563 | Feb 2001 | WO |
0137728 | May 2001 | WO |
0160263 | Aug 2001 | WO |
02054960 | Jul 2002 | WO |
02058780 | Aug 2002 | WO |
0271953 | Sep 2002 | WO |
0287678 | Nov 2002 | WO |
03005887 | Jan 2003 | WO |
03026482 | Apr 2003 | WO |
03037170 | May 2003 | WO |
2005013805 | Feb 2005 | WO |
2005030318 | Apr 2005 | WO |
2006042241 | Apr 2006 | WO |
2006066217 | Jun 2006 | WO |
Entry |
---|
Anatomy of the Lumbar Spine in MED TM MicroEndoscopic Discectomy (1997 Ludann Grand Rapids MI), 14 pgs. |
Dirksmeier et al., “Microendoscopic and Open Laminotomy and Discectomy in Lumbar Disc Disease” Seminars in Spine Surgery, 1999, 11(2): 138-146. |
METRx Delivered Order Form, 1999, 13 pages. |
Medtronic Sofamor Danek “METRx™ MicroDiscectomy System,” Medtronic Sofamor Danek USA,2000, 21 pgs. |
Medtronic Sofamor Danek “METRx System Surgical Technique,” 2004, 22 pages. |
“MetRx System MicroEndoscopic Discectomy: An Evolution in Minimally Invasive Spine Surgery,” Sofamor Danek, 1999, 6 pages. |
Smith and Foley “MetRx System MicroEndoscopic Discectomy: Surgical Technique” Medtronic Sofamor Danek, 2000, 24 pages. |
“Sofamor Danek MED Microendoscopic Discectomy System Brochure” including Rapp “New endoscopic lumbar technique improves access preserves tissue” Reprinted with permission from: Orthopedics Today, 1998, 18(1): 2 pages. |
Japanese Patent Office JP Patent Application No. 2006-528306 Office Action with English Translation, Jun. 10, 2009, 4 pages. |
Plaintiffs' Preliminary Invalidity Contentions re US Patents 7207949; 7470236 and 7582058, Sep. 18, 2009, 19 pages. |
Plaintiffs' Preliminary Invalidity Contentions—Appendices, Sep. 18, 2009, 191 pages. |
Plaintiffs' Supplemental Preliminary Invalidity Contentions re US Patents 7207949, 7470236, and 7582058, Sep. 29, 2009, 21 pages. |
Plaintiffs' Supplemental Preliminary Invalidity Contentions-Appendices, Sep. 29, 2009, 294 pages. |
Axon 501(k) Notification: Epoch 2000 Neurological Workstation, Dec. 3, 1997, 464 pages. |
Foley and Smith, “Microendoscopic Discectomy,” Techniques in Neurosurgery, 1997, 3(4):301-307. |
Medtronic Sofamor Danek “UNION™ / UNION-L™ Anterior & Lateral Impacted Fusion Devices: Clear choice of stabilization,” Medtronic Sofamor Danek, 2000, 4 pages. |
NuVasive Vector™Cannulae, 2000, 1 page. |
NuVasive Triad™Tri-Columnar Spinal EndoArthrodesis™via Minimally Invasive Guidance, 2000, 1 page (prior to Sep. 25, 2003). |
NuVasive Triad™Cortical Bone Allograft, 2000, 1 page (prior to Sep. 25, 2003). |
NuVasive Vertebral Body Access System, 2000, 1 page. |
Marina, “New Technology for Guided Navigation with Real Time Nerve Surveillance for Minimally Invasive Spine Discectomy & Arthrodesis,” Spineline, 2000, p. 39. |
NuVasive “INS-1 Screw Test,” 2001, 10 pages. |
NuVasive letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5 pages. |
NuVasive letter re 510k Guided Arthroscopy System, Oct. 5, 1999, 6 pages. |
NuVasive letter re 510k INS-1 Intraoperative Nerve Surveillance System, Nov. 13, 2000, 7 pages. |
“NuVasive™Receives Clearance to Market Two Key Elem Minimally Invasive Spine Surgery System,” Nov. 27, 2001, 20 pages. |
Schick et al., “Microendoscopic lumbar discectomy versus open surgery: an intraoperative EMG study,” Eur Spine J, 2002, 11: 20-26. |
NuVasive letter re: 510(k) for Neurovision JJB System (Summary), Sep. 25, 2001, 28 pages. |
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Jul. 3, 2003, 18 pages. |
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Mar. 1, 2004, 16 pages. |
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), May 26, 2005, 17 pages. |
NuVasive letter re: 510(k) Premarket Notification: Neurovision JJB System (Device Description), Jun. 24, 2005, 16 pages. |
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Sep. 14, 2006, 17 pages. |
NuVasive 510(k) Premarket Notification: Neurovision JJB System (Device Description), Aug. 20, 2007, 8 pages. |
NuVasive letter re: 510(k) Premarket Notification: Guided Spinal Arthroscopy System (Device Description), Feb. 1, 1999, 40 pages. |
NuVasive 510(k) Premarket Notification: Spinal System (Summary), Apr. 12, 2004, 10 pages. |
NuVasive 510(k) Summary NIM Monitor, Sep. 4, 1998, 4 pages. |
NuVasive correspondence re 510(k) Premarket Notification INS-1 Intraoperative Nerve Surveillance System: Section IV Device Description, pp. 12-51 (prior to Sep. 25 2003). |
Isley et al., “Recent Advances in Intraoperative Neuromonitoring of Spinal Cord Function: Pedicle Screw Stimulation Techniques,” American Journal of Electroneurodiagnostic Technology, Jun. 1997, 37(2): 93-126. |
Mathews et al., “Laparoscopic Discectomy with Anterior Lumbar Interbody 20(16): 1797-1802 Fusion,” SPINE, 1995,20(16): 1797-1802. |
Rose et al., “Persistently Electrified Pedicle Stimulation Instruments in Spinal Instrumentation: Techniques and Protocol Development,” SPINE, 1997, 22(3): 334-343. |
“Electromyography System,” International Search report from International Application No. PCT/US00/32329, Apr. 27, 2001, 9 pages. |
“Nerve Proximity and Status Detection System and Method,” International Search Report from International Application No. PCT/US01/18606, Oct. 18, 2001, 6 pages. |
“Relative Nerve Movement and Status Detection System and Method,” International Search Report from International Application No. PCT/US01/18579, Jan. 15, 2002, 6 pages. |
“System and Method for Determining Nerve Proximity Direction and Pathology During Surgery,” International Search Report from International Application No. PCT/US02/22247, Mar. 27, 2003, 4 pages. |
“System and Methods for Determining Nerve Direction to a Surgical Instrument,” International Search Report from International Application No. PCT/US03/02056, Aug. 12, 2003, 5 pages. |
“Systems and Methods for Performing Percutaneous Pedicle Integrity Assessments,” International Search Report from International Application No. PCT/US02/35047, Aug. 11, 2003, 5 pages. |
“Systems and Methods for Performing Surgery Procedures and Assessments,” International Search Report from International Application No. PCT/US02/30617, Jun. 5, 2003, 4 pages. |
Lenke et al., “Triggered Electromyographic Threshold for Accuracy of Pedicle Screw Placement,” Spine, 1995, 20(4): 1585-1591. |
“Brackmann II EMG System,” Medical Electronics, 1999, 4 pages. |
“Neurovision SE Nerve Locator/Monitor”, RLN Systems Inc. Operators Manual, 1999, 22 pages. |
“The Brackmann II EMG Monitoring System,” Medical Electronics Co. Operator's Manual Version 1.1, 1995, 50 pages. |
“The Nicolet Viking IV,” Nicolet Biomedical Products, 1999, 6 pages. |
Anderson et al., “Pedicle screws with stimulus-evoked EMG,” Spine, Department high electrical resistance: a potential source of error with of Orthopaedic Surgery University of Virginia, Jul. 15, 2002, 27(14): 1577-1581. |
Bose et al., “Neurophysiologic Monitoring of Spinal Nerve Root Function During Instrumented Posterior Lumber Spine Surgery,” Spine, 2002, 27(13):1444-1450. |
Calancie et al., “Stimulus-Evoked EMG Monitoring During Transpedicular Lumbosacral Spine Instrumentation” Spine, 1994, 19(24): 2780-2786. |
Clements et al., “Evoked and Spontaneous Electromyography to Evaluate Lumbosacral Pedicle Screw Placement,” Spine, 1996, 21(5): 600-604. |
Danesh-Clough et al. ,“The Use of Evoked EMG in Detecting Misplaced Thoracolumbar Pedicle Screws,” Spine, Orthopaedic Department Dunedin Hospital, Jun. 15, 2001, 26(12): 1313-1316. |
Darden et al., “A Comparison of Impedance and Electromyogram Measurements in Detecting the Presence of Pedicle Wall Breakthrough,” Spine, Charlotte Spine Center North Carolina, Jan., 15, 1998, 23(2): 256-262. |
Ebraheim et al., “Anatomic Relations Between the Lumbar Pedicle and the Adjacent Neural Surgery Structures,” Spine, Department of Orthopaedic Medical College of Ohio, Oct. 15, 1997, 22(20): 2338-2341. |
Ford et al. “Electrical Characteristics of Peripheral Nerve Stimulators Implications for Nerve Localization,” Regional Anesthesia, 1984, 9: 73-77. |
Glassman et al., “A Prospective Analysis of Intraoperative Electromyographic Monitoring of Pedicle Screw Placement With Computed Tomographic Scan Confirmation,” Spine, 1995, 20(12): 1375-1379. |
Greenblatt et al., “Needle Nerve Stimulator-Locator: Nerve Blocks with a New Instrument for Locating Nerves,” Anesthesia& Analgesia, 1962, 41(5): 599-602. |
Haig, “Point of view,” Spine, 2002, 27(24): 2819. |
Haig et al., “The Relation Among Spinal Geometry on MRI, Paraspinal Electromyographic Abnormalities, and Age in Persons Referred for Electrodiagnostic Testing of Low Back Symptoms,” Spine, Department of Physical Medicine and Rehabilitation University of Michigan, Sep. 1, 2002, 27(17): 1918-1925. |
Holland et al., “Higher Electrical Stimulus Intensities are Required to Activate Chronically Compressed Nerve Roots: Implications for Intraoperative Electromyographic Pedicle Screw Testing,” Spine, Department of Neurology, Johns Hopkins University School of Medicine, Jan. 15, 1998, 23(2): 224-227. |
Holland, “Intraoperative Electromyography During Thoracolumbar Spinal Surgery,” Spine, 1998, 23(17): 1915-1922 |
Journee et al., “System for Intra-Operative Monitoring of the Cortical Integrity of the Pedicle During Pedicle Screw Placement in Low-Back Surgery: Design and Clinical Results”, Sensory and Neuromuscular Diagnostic Instrumentation and Data Analysis I, 18th Annual International Conference on Engineering in Medicine and Biology Society, Amsterdam, 1996, pp. 144-145. |
Maguire et al., “Evaluation of Intrapedicular Screw Position Using Intraoperative Evoked Electromyography,” Spine, 1995, 20(9): 1068-1074. |
Martin et al. “Initiation of Erection and Semen Release by Rectal Probe Electrostimulation (RPE),” The Journal of Urology, The Williams& Wilkins Co., 1983, 129: 637-642. |
Minahan et al., “The Effect of Neuromuscular Blockade on Pedicle Screw Stimulation Thresholds” Spine, Department of Neurology, Johns Hopkins University School of Medicine, Oct. 1, 2000, 25(19): 2526-2530. |
Pither et al., “The Use of Peripheral Nerve Stimulators for Regional Anesthesia: Review of Experimental Characteristics Technique and Clinical Applications,” Regional Anesthesia, 1985, 10:49-58 |
Raj et al., “Infraclavicular Brachial Plexus Block—A New Approach” Anesthesia and Analgesia, 1973, (52)6: 897-904. |
Raj et al., “The Use of Peripheral Nerve Stimulators for Regional Anesthesia,” Clinical Issues in Regional Anesthesia, 1985, 1(4):1-6 |
Raj et al., “Use of the Nerve Stimulator for Peripheral Blocks,” Regional Anesthesia, Apr.-Jun. 1980, pp. 14-21. |
Raymond et al., “The Nerve Seeker: A System for Automated Nerve Localization,” Regional Anesthesia, 1992, 17(3): 151-162. |
Shafik, “Cavernous Nerve Simulation through an Extrapelvic Subpubic Approach: Role in Penile Erection,” Eur. Urol, 1994, 26: 98-102. |
Toleikis et al., “The Usefulness of Electrical Stimulation for Assessing Pedicle Screw Replacements,” Journal of Spinal Disorder, 2000, 13(4): 283-289. |
Medtronic Sofamor Danek “UNION™/UNION-L™Anterior & Lateral Impacted Fusion Devices: Surgical Technique” Medtronic Sofamor Danek, 2001, 20 pages. |
Defendant's Disclosure of Asserted Claims and Preliminary Infringement Contentions Regarding USP 7207949; 7470236 and 7582058, Aug. 31, 2009, 21 pages. |
Bergey et al., “Endoscopic Lateral Transpsoas Approach to the Lumbar Spine,” Spine, 2004, 29(15):1681-1688. |
Dezawa et al., “Retroperitoneal Laparoscopic Lateral Approach to the Lumbar Spine: A New Approach, Technique, and Clinical Trial,” Journal of Spinal Disorders, 2000, 13(2): 138-143. |
Gardocki, “Tubular diskectomy minimizes collateral damage: A logical progression moves spine surgery forward,” AAOS Now, 2009, 5 pages. |
Hovorka et al., “Five years' experience of retroperitoneal lumbar and thoracolumbar surgery,” Eur. Spine J., 2000, 9(1): S30-S34. |
Kossmann et al., “The use of a retractor system (SynFrame) for open, minimal invasive reconstruction of the anterior column of the thoracic and lumbar spine,” Eur Spine J., 2001, 10:396-402. |
Mayer, “A New Microsurgical Technique for Minimally Invasive Anterior Lumbar Interbody Fusion,” Spine, 1997, 22(6): 691-699. |
Mayer, “The ALIF Concept,” Eur Spine J., 2000, 9(1):S35-S43. |
Mayer and Wiechert, “Microsurgical Anterior Approaches to the Lumbar Spine for Interbody Fusion and Total Disc Replacement,” Neurosurgery, 2002, 51(2): 159-165. |
McAfee et al., “Minimally Invasive Anterior Retroperitoneal Approach to the Lumbar Spine: Emphasis on the Lateral BAK,” Spine, 1998, 23(13): 1476-1484. |
Rao, et al. “Dynamic retraction of the psoas muscle to expose the lumbar spine using the retroperitoneal approach,” J. Neurosurg Spine, 2006, 5: 468-470. |
Wolfla et al., “Retroperitoneal lateral lumbar interbody fusion with titanium threaded fusion cages,” J. Neurosurg (Spine 1), 2002, 96: 50-55. |
Larson and Maiman, “Surgery of the Lumbar Spine,” Thieme Medical Publishers, Inc., 1999, pp. 305-319. |
Medtronic XOMED Surgical Products, Inc., NIM-Response Nerve Integrity Monitor Intraoperative EMG Monitor User's Guide, Revision B, 2000, 47 pages. |
“NuVasive's spine surgery system cleared in the US,” Pharm & Medical Industry Week, Dec. 10, 2001, 1 page. |
Pimenta, “Initial Clinical Results of Direct Lateral, Minimally Invasive Access to the Lumbar Spine for Disc Nucleus Replacement Using a Novel Neurophysiological Monitoring System.” The 9th IMAST, May, 2002, 1 page. |
Pimenta et al., “The Lateral Endoscopic Transpsoas Retroperitoneal Approach (Letra) for Implants in the Lumbar Spine,” World Spine II—Second Interdisciplinary Congress on Spine Care, Aug. 2003, 2 pages. |
Crock, H.V. MD., “Anterior Lumbar Interbody Fusion,” Clinical Orthopaedics and Related Research, Number One Hundred Sixty Five, 1982, pp. 157-163, 13 pages. |
Mayer and Brock, “Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy,” J. Neurosurg, 1993, 78: 216-225. |
Schaffer and Kambin, “Percutaneous Posterolateral Lumbar Discectomy and Decompression with a 6.9-Millimeter Cannula,” The Journal of Bone and Joint Surgery, 1991, 73A(6): 822-831. |
Friedman, “Percutaneous discectomy: An alternative to chemonucleolysis,” Neurosurgery, 1983, 13(5): 542-547. |
Request for Inter PartesReexamination in re U.S. Patent 7,905,840, dated Feb. 8, 2012, 204 pages. |
Brau, “Chapter 22: Anterior Retroperitoneal Muscle-Sparing approach to L2-S1 of the Lumbar Spine,” Surgical Approaches to the Spine. Robert G. Watkins, MD. (ed) 2003. Pages 165-181. |
Kossmann et al., “Minimally Invasive Vertebral Replacement with Cages in Thoracic and Lumbar Spine,” European Journal of Trauma, 2001, 27: 292-300. |
Mayer H. M. (ed.) Minimally Invasive Spine Surgery: A Surgical Manual. 2000. 51 pages. |
Pimenta et al., “Implante de protese de nucleo pulposo: analise inicial,” Journal Brasileiro de Neurocirurgia, 2001, 12(2): 93-96. |
Traynelis, “Spinal Arthroplasty,” Neurological Focus, 2002, 13(2): 12 pages. |
Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999. 43 pages. |
Amended Complaint for NuVasive, Inc. v. Globus Medical, Inc., Case No. 1:10-cv-0849 (D. Del., Oct. 5, 2010), 28 pages. |
Request for Inter PartesReexamination in re U.S. Patent 7,819,801, dated Feb. 8, 2012, 89 pages. |
Kossman et al., “The use of a retractor system (SynFrame) for open, minimal invasive reconstruction of the anterior column of the thoracic and lumbar spine,” Eur Spine J, 2001, 10: 396-402. |
de Peretti et al., “New possibilities in L2-L5 lumbar arthrodesis using a lateral retroperitoneal approach assisted by laparoscopy: preliminary results,” Eur Spine J, 1996, 5: 210-216. |
Litwin et al., “Hand-assisted laparoscopic surgery (HALS) with the handport system,” Annals of surgery, 2000, 231(5): 715-723. |
Acland's Video Atlas of Human Anatomy, Section 3.1.7: Paravertebral Muscles. Available online: http://aclandanatomy.com/abstract/4010463. Accessed Jul. 11, 2012. |
MedlinePlus, a Service of the U.S. National Library of Medicine and National Institutes of Health. Available online: http://www.nlm.nih.gov/medlineplus/. Accessed Jul. 11, 2012. |
Baulot et al., Adjuvant Anterior Spinal Fusion Via Thoracoscopy, Lyon Chirurgical, 1994, 90(5): 347-351 including English Translation And Certificate of Translation. |
Leu et al., “Percutaneous Fusion of the Lumbar Spine,” Spine, 1992, 6(3): 593-604. |
Rosenthal et al., “Removal of a Protruded Thoracic Disc Using Microsurgical Endoscopy,” Spine, 1994, 19(9): 1087-1091. |
Counterclaim Defendants' Corrected Amended Invalidity Contentions re U.S. Patent Nos. 8,000,782; 8,005,535; 8,016,767; 8,192,356; 8,187,334; 8,361,156, D652,922; D666,294 re Case No. 3:12-cv-02738-CAB(MDD), dated Aug. 19, 2013, 30 pages. |
Petition for Inter Partes Review IPR2014-00034, filed Oct. 8, 2013, 65 pages. |
Petition for Inter Partes Review IPR2014-00035, filed Oct. 8, 2013, 65 pages. |
Declaration of Lee Grant, from IPR2014-00034, Oct. 7, 2013, 36 pages. |
Declaration of David Hacker from IPR2014-00034, Oct. 4, 2013, 64 pages. |
NuVasive, Inc's Opening Claim Construction Brief Regarding U.S. Patent Nos. 8,000,782; 8,005 535; 8,016,767; 8,192,356; 8,187,334; 8,361,156; D652,922; and 5,676,146 C2, filed Sep. 3, 2013, in Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 3:12-cv-02738-CAB-MDD (S.D. Cal.)., 34 pages. |
Petition for Inter Partes Review IPR2014-00073, filed Oct. 18, 2013, 65 pages. |
Petition for Inter Partes Review IPR2014-00074, filed Oct. 18, 2013, 65 pages. |
Petition for Inter Partes Review IPR2014-00075, filed Oct. 21, 2013, 66 pages. |
Petition for Inter Partes Review IPR2014-00076, filed Oct. 21, 2013, 65 pages. |
Petition for Inter Partes Review IPR2014-00081, filed Oct. 22, 2013, 64 pages. |
Petition for Inter Partes Review IPR2014-00087, filed Oct. 22, 2013, 64 pages. |
Declaration of Lee Grant, from IPR2014-00073, Oct. 9, 2013, 36 pages. |
Declaration of David Hacker, from IPR2014-00073, Oct. 10, 2013, 64 pages. |
U.S. Appl. No. 60/392,214, filed Jun. 26, 2002, 97 pages. |
Amendment in reply to Feb. 15, 2012 Office Action in U.S. Appl. No. 12/635,418, dated Mar. 16, 2012, 24 pages. |
Decision on Appeal in Inter Partes Reexamination U.S. Appl. No. 95/001,247, dated Mar. 18, 2013, 49 pages. |
Declaration of Lee Grant, from IPR2014-00074, Oct. 9, 2013, 36 pages. |
Declaration of David Hacker, from IPR2014-00074, Oct. 10, 2013, 64 pages. |
Declaration of David Hacker, from IPR2014-00075, Oct. 10, 2013, 64 pages. |
Amendment in reply to Action of Feb. 7, 2011 and Notice of May 12, 2011, in U.S. Appl. No. 11/789,284, dated May 17, 2011, 16 pages. |
Notice of Allowance in U.S. Appl. No. 11/789,284, dated Jul. 18, 2011, 8 pages. |
Office action from U.S. Appl. No. 11/789,284, dated Feb. 7, 2011, 10 pages. |
Merriam-Webster's Collegiate Dictionary, p. 65 (10th ed. 1998). |
Declaration of Lee Grant, from IPR2014-00076, Oct. 9, 2013, 36 pages. |
Moed et al., “Evaluation of Intraoperative Nerve-Monitoring During Insertion of an Iliosacral Implant in an Animal Model, Journal of Bone and Joint Surgery,” 1999, 81-A(11): 9. |
Declaration of Lee Grant, from IPR2014-0081, Oct. 9, 2013, 36 pages. |
Declaration of David Hacker from IPR2014-00081, Oct. 10, 2013, 64 pages. |
U.S. Appl. No. 60/325,424, filed Sep. 25, 2001, 346 pages. |
Declaration of Lee Grant, from IPR2014-0087, Oct. 9, 2013, 36 pages. |
Declaration of David Hacker from IPR2014-00087, Oct. 10, 2013, 64 pages. |
Request for Inter Partes Reexamination in re: U.S. Patent 7,691,057, dated Feb. 8, 2012, 50 pages. |
Declaration of Daniel Schwartz, Ph.D. from IPR2014-00034, Oct. 7, 2013, 1056 pages. |
Declaration of Daniel Schwartz, Ph.D. from IPR2014-00035, Oct. 7, 2013, 661 pages. |
510(K) No. K002677, approved by the FDA on Nov. 13, 2000, 634 pages. |
510(K) No. K013215, approved by the FDA on Oct. 16, 2001, 376 pages. |
Declaration of Robert G. Watkins, from IPR2014-00073, Oct. 18, 2013, 1101 pages. |
Declaration of Daniel Schwartz, from IPR2014-00073, Oct. 12, 2013, 1226 pages. |
Declaration of Robert G. Watkins, from IPR2014-00074, Oct. 18, 2013, 548 pages. |
Declaration of Daniel Schwartz, from IPR2014-00074, Oct. 12, 2013, 565 pages. |
Declaration of Robert G. Watkins, from IPR2014-00075, Oct. 18, 2013, 674 pages. |
Declaration of Daniel Schwartz, from IPR2014-00075, Oct. 12, 2013, 1107 pages. |
Declaration of Robert G. Watkins, from IPR2014-00076, Oct. 18, 2013, 543 pages. |
Declaration of Daniel Schwartz, from IPR2014-00076, Oct. 12, 2013, 1247 pages. |
Declaration of David Hacker, from IPR2014-00076, Oct. 10, 2013, 64 pages. |
Declaration of Daniel Schwartz, from IPR2014-0081, Oct. 21, 2013, 585 pages. |
Declaration of Daniel Schwartz from IPR2014-0087, Oct. 21, 2013, 585 pages. |
Number | Date | Country | |
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61471069 | Apr 2011 | US |