I. Field of the Invention
The present invention relates to nerve surveillance systems and to cannulae systems for use in minimally invasive spinal surgery.
II. Discussion of the Prior Art
A significant danger of performing intervertebral operations or accessing an intervertebral space during spine surgery is that of inadvertently contacting or damaging the para-spinal nerves, including the exiting nerve roots, traversing nerves and the nerves of the cauda equina. The exact location of these para-spinal nerves cannot be determined prior to the commencement of surgery. Moreover, intervertebral spaces in the spine have other sensitive nerves disposed at locations which are not entirely predictable prior to insertion of the surgical tool into the intervertebral area. Accordingly, the danger of pinching or damaging spinal nerves when accessing an intervertebral space has proven to be quite limiting to the methods and devices used during minimally invasive spinal surgery. In addition, as cannulae are received through the patient's back, such as when performing minimally invasive spinal surgery, minor blood vessels are ruptured, thereby blocking the surgeon's vision inside the intervertebral region after the cannula has been inserted.
The present invention provides nerve surveillance probes which are adapted to assist the surgeon in identifying the presence and location of para-spinal nerves as the probe is advanced during minimally-invasive surgery, thus providing a device for guiding the path of other surgical instruments to be inserted into this intervertebral space. In a preferred aspect of the present invention, an expandable tip cannula system is provided which functions both as an access portal for spinal surgery and as a system for nerve surveillance such that the presence and relative position of para-spinal nerves can be detected as the expandable tip cannula is inserted through the patient's facia and para-spinal musculature. An advantage of determining the position of the para-spinal nerve with respect to the distal tip of the cannula in particular is that the para-spinal nerve can be avoided or gently moved out of the surgeon's way while inserting the cannula. Accordingly, in a preferred aspect, the present invention provides a cannulated system which is adapted to assist the surgeon in guiding the path of surgical instruments received into the intervertebral space, while identifying the presence and location of para-spinal nerves as the cannula is advanced to a patient's intervertebral space during minimally invasive surgery.
Optionally, the present nerve surveillance expandable tip cannula may also be adapted to selectively electrically induce cauterization of severed blood vessels when the cannula or other surgical instruments sever small blood vessels when they are inserted percutaneously into the patient and are advanced along a path into the patient's intervertebral space. An additional advantage of the present cannula system therefore is that, prior to piercing the annulus of an intervertebral disc, vessels on the surface of the disc may be cauterized to assure clear vision inside the disc after surgical entry is made.
In one embodiment, the present expandable tip nerve surveillance cannula preferably comprises a hollow tubular body with an expandable tip portion mounted at its distal end. In a preferred aspect of the invention, the expandable tip portion comprises a plurality of generally triangular shaped petals which are held together in a radially-inwardly tapering arrangement by breakable seals disposed between adjacent petals. Since the expandable tip portion of the cannula tapers to a narrow blunt end, the cannula can be easily pushed through the patient's facia and spinal musculature using blunt dissection, while minimizing the amount of cutting and tearing of such structures.
Alternatively, a central electrode can be disposed on a central obturator passing though the cannula and a second electrode can be disposed on a distal end of a second cannula, wherein the second cannula is used to open the petals.
An obturator shaft which is slidably received within the hollow tubular cannula body provides support for the cannula, giving the cannula sufficient strength such that the cannula can be inserted percutaneously through the patient's facia and para-spinal musculature. Preferably, the obturator has a large solid handle which allows the surgeon to grasp and push the cannula through the resistance of the facia and para-spinal musculature.
After the cannula has been inserted and is resting on the patient's annulus, an inner cannula or rod which is slidably received within the cannula is then used to separate the breakable seals, opening the petals radially outwards to a distance sufficient to provide access for surgical instruments passing therethrough.
In some preferred aspects, an electrode is disposed in each of the petals, and most preferably at or near the distal end of each of the petals. In other aspects of the invention, a plurality of electrodes are radially disposed about the distal end of the obturator and the electrodes protrude out of a small hole defined by truncated petals, as will be explained.
In various aspects of the present invention, the electrodes can be powered at a low level to thereby sense the position of a para-spinal nerve through continuous real time electromyographic monitoring, or alternatively, the electrodes can be powered at a higher level such that they operate to cauterize blood vessels. Safety systems ensure that power levels sufficient to cause cauterization are not activated if a nerve is sensed to be near the electrodes at the distal end of the cannula.
In alternate embodiments, the present invention comprises an elongated nerve surveillance probe having one or more electrodes at its distal tip. In such aspects, the nerve surveillance probe is preferably advanced to the patient's intervertebral space through a cannula. In other alternate embodiments, the present nerve surveillance probe is received into the patient through various cannulae and expandable mesh trocars.
As will be set forth herein, the present invention encompasses both nerve surveillance probes which are received through cannulae, and various expandable tip cannulae comprising nerve surveillance probes at their distal ends.
In a first preferred embodiment, as is seen in
In an exemplary method of application, (as is shown in
In one preferred aspect of the present invention, an expandable mesh 32 is received over first cannula 30 such that expansion of this mesh from the contracted position shown in
Also in a preferred aspect as shown in
As is seen in
Referring to
In another aspect of the invention, radially disposed electrodes 12, 14, 16, and 18 can be used for electrocoagulation of blood vessels, for example, blood vessels on the patient's annulus when accessing the patient's intervertebral region. Specifically, as a plurality of electrodes are disposed at the distal end of probe 9, it is possible to pass current between various electrodes, thus cauterizing adjacent blood vessels.
In another aspect of the invention, radially disposed electrodes 12, 14, 16, and 18 can be used to assist in avoiding, or alternatively in moving, nerve 20 as follows. Referring to
In another aspect of the present invention as shown in
It is to be understood that the present nerve surveillance probes can be used without the expandable mesh system of
As can also be appreciated the present nerve surveillance probes are able to detect the presence of any other efferent skeletal motor nerve in addition to the spinal nerve and can thus be used in various surgical procedures. Alternatively, using evoked potential electromyography, the present nerve surveillance probes are also adapted to sense the presence of afferent sensory nerves in response to signals received in the spinal cord or cerebral cortex.
In a second preferred embodiment, the present invention provides an expandable tip nerve surveillance cannula system 110 comprising an endoscopic hollow cannula shaft 112 having an expandable tip 113 comprised of a plurality of petals 114 (the details of petals 114 are better shown in
As seen in
First, electrodes 116 can be used for electromyography, and in particular to sense the presence and relative position of para-spinal nerves as cannula shaft 112 is advanced. Referring to
Alternatively, when none of electrodes 116a, 116b, 116c, 116d, 116e and 116f indicate the presence of a nerve, electrodes 116a, 116b, 116c, 116d, 116e and 116f can be powered to a higher level such that a cauterization of minor blood vessels can be achieved by passing increased electric current between each of the various adjacent electrodes, thus cauterizing adjacent blood vessels. Preferably, the present invention comprises a safety system such that cauterization power levels for electrodes 116 are not activated when any of electrodes 116 sense the presence of a para-spinal nerve thereby.
Preferably, each of electrodes 116a, 116b, 116c, 116d, 116e and 116f are operated in sequence, affording a sufficient latency period therebetween for the detection of an electromyographic signal.
As seen in
Subsequent to being positioned at the patient's annulus, obturator 120 is removed from cannula shaft 112. As seen in
As can be seen in
In an alternate design, as shown in
In this alternate design of
In another alternate embodiment, a peel back cannula having an expandable tip is provided. Referring to
An advantage of being disposed axially along the cannula is that electrodes 151 will be able to sense the position of a nerve relative to the cannula in an axial dimension. Similarly, an advantage of being disposed radially around the cannula is that the electrodes will be able to sense the position of a nerve relative to the cannula in a radial dimension. It is to be understood that all embodiments of the present invention comprise the concept of nerve surveillance electrodes disposed both radially around and axially along the nerve surveillance cannula or obturator, and that the radial electrode placement shown in the design of
In a preferred method of operation, cannula 150 is advanced such that its tapered end 152 is adjacent nerve 160 as is seen in
A narrow inner cannula 157 may also be provided. Cannula 157 is received around obturator 155 and within cannula 150. When the operator has determined it is safe and desirable to open cannula 150, inner cannula 157 is advanced to the position shown in
Tear away line 153 may be formed by scribing the polymeric material forming cannula 150. Tear away line 153 preferably runs some distance along opposite sides of the open end 152 of cannula 150. Alternatively, tear away line 153 can be disposed along the top and bottom of cannula 150 as shown.
As shown in
The operative site or target site may comprise a patient's intervertebral disk 240 when the present invention is used in minimally invasive spinal surgery. It is to be understood, however, that the present expandable tip cannula can be used in all manner of minimally invasive surgery and is especially useful for approaching any target site having sensitive nerves adjacent thereto since the present invention is specifically adapted to gently push the nerve out of the way as the petals are opened, thereby providing a cannulated access portal for the insertion and removal of various surgical devices through cannula 220.
Preferably, obturator 310 further comprises a centrally disposed electrode 320. Electrode 320, being axially displaced from electrodes 316 is adapted to sense the position of a nerve in the axial direction as probe 300 approaches the nerve. Subsequent to placement at the patient's intervertebral space, an internal cannula 315 can be advanced distally to open petals 314 with obturator 310 being advanced slightly to first un-latch the distal ends of petals 314 and then withdrawn from cannula 300, providing a cannulated access to the patient's intervertebral space.
As is shown in
As is seen in
This application is a continuation of U.S. application Ser. No. 13/494, 908, filed Jun. 6, 2012 (now issued as U.S. Pat. No. 8,489,170), which is a continuation of U.S. application Ser. No. 11/489,020, filed Jul. 18, 2006 (now abandoned), which is a divisional of U.S. application Ser. No. 10/431,619, filed May 7, 2003 (now issued as U.S. Pat. No. 7,079,883), which is a divisional of U.S. patent application Ser. No. 09/325,998, filed Jun. 4, 1999 (now issued as U.S. Pat. No. 6,564,078), which claims benefit under 35 U.S.C. §119(e) from U.S. Provisional Patent Application Ser. No. 60/113,651 filed Dec. 23, 1998; U.S. Provisional Patent Application Ser. No. 60/120,663 filed Feb. 19, 1999; and U.S. Provisional Patent Application Ser. No. 60/123,268 filed Mar. 8, 1999; the complete disclosures of which are hereby incorporated herein by reference in their entirety for all purposes.
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. | Jun 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 |
4824433 | Marz et al. | Apr 1989 | A |
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 | Alexgaard | 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 |
5885219 | Nightengale | Mar 1999 | A |
5888196 | Bonutti | Mar 1999 | A |
5902231 | Foley et al. | May 1999 | A |
5928139 | Koros et al. | Jul 1999 | A |
5928158 | Aristides | Jul 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 | Finnerman | Dec 1999 | 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 |
6095987 | Schmulewitz | 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 |
6181961 | Prass | Jan 2001 | B1 |
6196969 | Bester et al. | Mar 2001 | B1 |
6206826 | Mathews et al. | Mar 2001 | B1 |
6224549 | Drongelen | May 2001 | B1 |
6259945 | Epstein 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 |
6312392 | Herzon | Nov 2001 | B1 |
6325764 | Griffith et al. | Dec 2001 | B1 |
6334068 | Hacker | Dec 2001 | B1 |
6425859 | Foley et al. | Jul 2002 | B1 |
6425901 | Zhu et al. | Jul 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 |
6500128 | Marino | Dec 2002 | B2 |
6524320 | DiPoto | Feb 2003 | B2 |
6535759 | Epstein et al. | Mar 2003 | B1 |
6564078 | Marino et al. | May 2003 | B1 |
6579244 | Goodwin | Jun 2003 | B2 |
6620157 | Dabney et al. | Sep 2003 | B1 |
6719692 | Kleffner et al. | Apr 2004 | B2 |
6760616 | Hoey et al. | Jul 2004 | B2 |
6796985 | Bolger et al. | Sep 2004 | B2 |
6810281 | Brock et al. | Oct 2004 | B2 |
6847849 | Mamo et al. | Jan 2005 | B2 |
6849047 | Goodwin | Feb 2005 | B2 |
6855105 | Jackson, III et al. | Feb 2005 | B2 |
6902569 | Parmer et al. | Jun 2005 | B2 |
6926728 | Zucherman et al. | Aug 2005 | B2 |
6929606 | Ritland | Aug 2005 | B2 |
6945933 | Branch | Sep 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 |
7207949 | Miles et al. | Apr 2007 | B2 |
7226451 | Shluzas et al. | Jun 2007 | B2 |
7261688 | Smith et al. | Aug 2007 | B2 |
7582058 | Miles et al. | Sep 2009 | B1 |
7962191 | Marino et al. | Jun 2011 | B2 |
8165653 | Marino et al. | Apr 2012 | B2 |
8489170 | Marino et al. | Jul 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 |
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 |
20030105503 | Marino | Jun 2003 | A1 |
20030149341 | Clifton | Aug 2003 | A1 |
20030225405 | Weiner | Dec 2003 | 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 |
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 |
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 |
Number | Date | Country |
---|---|---|
299 08 259 | Jul 1999 | DE |
0 334 116 | Sep 1989 | EP |
0 567 424 | Oct 1993 | EP |
0 972 538 | Jan 2000 | EP |
2 795 624 | Jan 2001 | FR |
793186 | May 1990 | JP |
10-14928 | Mar 1996 | JP |
3019990007098 | Nov 1999 | KR |
9428824 | Dec 1994 | WO |
9700702 | Jan 1997 | WO |
9823324 | Jun 1998 | WO |
9952446 | Oct 1999 | WO |
0038574 | Jul 2000 | WO |
0066217 | Nov 2000 | WO |
0067645 | Nov 2000 | WO |
0137728 | May 2001 | WO |
02054960 | Jul 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™ MicroDisectomy 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. |
NuVasive Triad™ Tri-Columnar Spinal EndoArthrodesis™ via Minimally Invasive Guidance, 1 page (prior to Sep. 25, 2003). |
Medtronic Sofamor Danek “UNION™ / UNION-L™ Anterior & Lateral Impacted Fusion Devices: Clear choice of stabilization,” Medtronic Sofamor Danek, 2000, 4 pages. |
NuVasive Vector™ Cannulae, 1 page (prior to Sep. 25, 2003). |
NuVasive Triad™ Cortical Bone Allograft, 1 page (prior to Sep. 25, 2003). |
NuVasive Vertebral Body Access System, 1 page (prior to Sep. 25, 2003). |
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. |
“NuVasiveTM 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 Electroneurodagnostic Technology, Jun. 1997, 37(2): 93-126. |
Mathews et al., “Laparoscopic Discectomy with Anterior Lumbar Interbody 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 high electrical resistance: a potential source of error with stimulus-evoked EMG,” Spine, Department 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 Structures,” Spine, Department of Orthopaedic Surgery 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. |
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. |
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. |
Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999. 43 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. |
Acland's Video Atlas of Human Anatomy, Section 3.1.7: Paravertebral Muscles. Available online: http://aclandanatomy.com/abstract/4010463. 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. |
Merriam-Webster's Collegiate Dictionary, p. 65 (10th ed. 1998). |
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. |
Number | Date | Country | |
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20140024963 A1 | Jan 2014 | US |
Number | Date | Country | |
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60120663 | Feb 1999 | US | |
60113651 | Dec 1998 | US | |
60123268 | Mar 1999 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 10431619 | May 2003 | US |
Child | 11489020 | US | |
Parent | 09325998 | Jun 1999 | US |
Child | 10431619 | US |
Number | Date | Country | |
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Parent | 13494908 | Jun 2012 | US |
Child | 13943725 | US | |
Parent | 11489020 | Jul 2006 | US |
Child | 13494908 | US |