Surgical access system and related methods

Information

  • Patent Grant
  • 11219440
  • Patent Number
    11,219,440
  • Date Filed
    Monday, June 17, 2019
    5 years ago
  • Date Issued
    Tuesday, January 11, 2022
    2 years ago
Abstract
A surgical access system including a tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures before, during, and after the establishment of an operative corridor to a surgical target site.
Description
BACKGROUND OF THE INVENTION
I. Field of the Invention

The present invention relates generally to systems and methods for performing surgical procedures and, more particularly, for accessing a surgical target site in order to perform surgical procedures.


II. Discussion of the Prior Art

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. The access systems developed to date, however, fail in various respects to meet all the needs of the surgeon population.


One drawback associated with prior art surgical access systems relates to the ease with which the operative corridor can be created, as well as maintained over time, depending upon the particular surgical target site. For example, when accessing surgical target sites located beneath or behind musculature or other relatively strong tissue (such as, by way of example only, the psoas muscle adjacent to the spine), it has been found that advancing an operative corridor-establishing instrument directly through such tissues can be challenging and/or lead to unwanted or undesirable effects (such as stressing or tearing the tissues). While certain efforts have been undertaken to reduce the trauma to tissue while creating an operative corridor, such as (by way of example only) the sequential dilation system of U.S. Pat. No. 5,792,044 to Foley et al., these attempts are nonetheless limited in their applicability based on the relatively narrow operative corridor. More specifically, based on the generally cylindrical nature of the so-called “working cannula,” the degree to which instruments can be manipulated and/or angled within the cannula can be generally limited or restrictive, particularly if the surgical target site is a relatively deep within the patient.


Efforts have been undertaken to overcome this drawback, such as shown in U.S. Pat. No. 6,524,320 to DiPoto, wherein an expandable portion is provided at the distal end of a cannula for creating a region of increased cross-sectional area adjacent to the surgical target site. While this system may provide for improved instrument manipulation relative to sequential dilation access systems (at least at deep sites within the patient), it is nonetheless flawed in that the deployment of the expandable portion may inadvertently compress or impinge upon sensitive tissues adjacent to the surgical target site. For example, in anatomical regions having neural and/or vasculature structures, such a blind expansion may cause the expandable portion to impinge upon these sensitive tissues and cause neural and/or vasculature compromise, damage and/or pain for the patient.


This highlights yet another drawback with the prior art surgical access systems, namely, the challenges in establishing an operative corridor through or near tissue having major neural structures which, if contacted or impinged, may result in neural impairment for the patient. Due to the threat of contacting such neural structures, efforts thus far have largely restricted to establishing operative corridors through tissue having little or substantially reduced neural structures, which effectively limits the number of ways a given surgical target site can be accessed. This can be seen, by way of example only, in the spinal arts, where the exiting nerve roots and neural plexus structures in the psoas muscle have rendered a lateral or far lateral access path (so-called trans-psoas approach) to the lumbar spine virtually impossible. Instead, spine surgeons are largely restricted to accessing the spine from the posterior (to perform, among other procedures, posterior lumbar interbody fusion (PLIF)) or from the anterior (to perform, among other procedures, anterior lumbar interbody fusion (ALIF)).


Posterior-access procedures involve traversing a shorter distance within the patient to establish the operative corridor, albeit at the price of oftentimes having to reduce or cut away part of the posterior bony structures (i.e. lamina, facets, spinous process) in order to reach the target site (which typically comprises the disc space). Anterior-access procedures are relatively simple for surgeons in that they do not involve reducing or cutting away bony structures to reach the surgical target site. However, they are nonetheless disadvantageous in that they require traversing through a much greater distance within the patient to establish the operative corridor, oftentimes requiring an additional surgeon to assist with moving the various internal organs out of the way to create the operative corridor.


The present invention is directed at eliminating, or at least minimizing the effects of, the above-identified drawbacks in the prior art.


SUMMARY OF THE INVENTION

The present invention accomplishes this goal by providing a novel access system and related methods which, according to one embodiment, involves detecting the existence of (and optionally the distance and/or direction to) neural structures before, during, and after the establishment of an operative corridor through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient. It is expressly noted that, although described herein largely in terms of use in spinal surgery, the access system of the present invention is suitable for use in any number of additional surgical procedures wherein tissue having significant neural structures must be passed through (or near) in order to establish an operative corridor.


The present invention accomplishes this goal by providing a novel access system and related methods which involve: (1) distracting the tissue between the patient's skin and the surgical target site to create an area of distraction (otherwise referred to herein as a “distraction corridor”); (2) retracting the distraction corridor to establish and maintain an operative corridor; and/or (3) detecting the existence of (and optionally the distance and/or direction to) neural structures before, during and after the establishment of the operative corridor through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient.


As used herein, “distraction” or “distracting” is defined as the act of creating a corridor (extending to a location at or near the surgical target site) having a certain cross-sectional area and shape (“distraction corridor”), and “retraction” or “retracting” is defined as the act of creating an operative corridor by increasing or maintaining the cross-sectional area of the distraction corridor (and/or modifying its shape) with at least one retractor blade such that surgical instruments can be passed through operative corridor to the surgical target site.


According to one broad aspect of the present invention, the access system comprises a tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures during the steps tissue distraction and/or retraction. To accomplish this, one or more stimulation electrodes are provided on the various components of the distraction assemblies and/or retraction assemblies, a stimulation source (e.g. voltage or current) is coupled to the stimulation electrodes, a stimulation signal is emitted from the stimulation electrodes as the various components are advanced towards the surgical target site, and the patient is monitored to determine if the stimulation signal causes muscles associated with nerves or neural structures within the tissue to innervate. If the nerves innervate, this indicates that neural structures may be in close proximity to the distraction and/or retraction assemblies.


This monitoring may be accomplished via any number of suitable fashions, including but not limited to observing visual twitches in muscle groups associated with the neural structures likely to found in the tissue, as well as any number of monitoring systems. In either situation (traditional EMG or surgeon-driven EMG monitoring), the access system of the present invention may advantageously be used to traverse tissue that would ordinarily be deemed unsafe or undesirable, thereby broadening the number of manners in which a given surgical target site may be accessed.


The tissue distraction assembly is capable of, as an initial step, distracting a region of tissue between the skin of the patient and the surgical target site. The tissue retraction assembly is capable of, as a secondary step, being introduced into this distracted region to thereby define and establish the operative corridor. Once established, any of a variety of surgical instruments, devices, or implants may be passed through and/or manipulated within the operative corridor depending upon the given surgical procedure. The electrode(s) are capable of, during both tissue distraction and retraction, detecting the existence of (and optionally the distance and/or direction to) neural structures such that the operative corridor may be established through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient. In this fashion, the access system of the present invention may be used to traverse tissue that would ordinarily be deemed unsafe or undesirable, thereby broadening the number of manners in which a given surgical target site may be accessed.


The tissue distraction assembly may include any number of components capable of performing the necessary distraction. By way of example only, the tissue distraction assembly may include a K-wire, an initial dilator (of split construction or traditional non-slit construction), and one or more dilators of traditional (that is, non-split) construction for performing the necessary tissue distraction to receive the remainder of the tissue retractor assembly thereafter. One or more electrodes may be provided on one or more of the K-wire and dilator(s) to detect the presence of (and optionally the distance and/or direction to) neural structures during tissue distraction.


The tissue retraction assembly may include any number of components capable of performing the necessary retraction. By way of example only, the tissue retraction assembly may include one or more retractor blades extending proximally from the surgical target site for connection with a pivot linkage assembly. The pivot linkage includes first and second pivot arms capable of maintaining the retractor blades in a first, closed position to facilitate the introduction of the retractor blades over the distraction assembly. Thereafter, the pivot linkage may be manipulated to open the retractor assembly; that is, allowing the retractor blades to separate from one another (preferably simultaneously) to create an operative corridor to the surgical target site. In a preferred embodiment, this is accomplished by maintaining a posterior retractor blade in a fixed position relative to the surgical target site (so as to avoid having it impinge upon any exiting nerve roots near the posterior elements of the spine) while the additional retractor blades (i.e. cephalad, caudal and/or anterior retractor blades) are moved or otherwise translated away from the posterior retractor blade (and each other) so as to create the operative corridor in a fashion that doesn't infringe upon the region of the exiting nerve roots. This is accomplished, in part, through the use of a secondary pivot linkage coupled to the pivot linkage assembly, which allows the posterior retractor blade to remain in a constant position while the other retractor blades are moved. In one embodiment, the anterior retractor blade may be positioned after the posterior, cephalad, and caudal retractor blades are positioned into the fully retracted position. This may be accomplished by coupling the anterior retractor blade to the pivot linkage via an arm assembly.


The retractor blades may be optionally dimensioned to receive and direct a rigid shim element to augment the structural stability of the retractor blades and thereby ensure the operative corridor, once established, will not decrease or become more restricted, such as may result if distal ends of the retractor blades were permitted to “slide” or otherwise move in response to the force exerted by the displaced tissue. In a preferred embodiment, only the posterior and anterior retractor blades are equipped with such rigid shim elements, which are advanced into the disc space after the posterior and anterior retractor blades are positioned (posterior first, followed by anterior after the cephalad, caudal and anterior blades are moved into the fully retracted position). The rigid shim elements are preferably oriented within the disc space such that they distract the adjacent vertebral bodies, which serves to restore disc height. They are also preferably advanced a sufficient distance within the disc space (preferably past the midline), which serves the dual purpose of preventing post-operative scoliosis and forming a protective barrier (preventing the migration of tissue (such as nerve roots) into the operative field and the inadvertent advancement of instruments outside the operative field).


The retractor blades may optionally be equipped with a mechanism for transporting or emitting light at or near the surgical target site to aid the surgeon's ability to visualize the surgical target site, instruments and/or implants during the given surgical procedure. According to one embodiment, this mechanism may comprise, but need not be limited to, providing one or more strands of fiber optic cable within the walls of the retractor blades such that the terminal (distal) ends are capable of emitting light at or near the surgical target site. According to another embodiment, this mechanism may comprise, but need not be limited to, constructing the retractor blades of suitable material (such as clear polycarbonate) and configuration such that light may be transmitted generally distally through the walls of the retractor blade light to shine light at or near the surgical target site. This may be performed by providing the retractor blades having light-transmission characteristics (such as with clear polycarbonate construction) and transmitting the light almost entirely within the walls of the retractor blade (such as by frosting or otherwise rendering opaque portions of the exterior and/or interior) until it exits a portion along the interior (or medially-facing) surface of the retractor blade to shine at or near the surgical target site. The exit portion may be optimally configured such that the light is directed towards the approximate center of the surgical target site and may be provided along the entire inner periphery of the retractor blade or one or more portions therealong.





BRIEF DESCRIPTION OF THE DRAWINGS

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:



FIG. 1 is a perspective view of a tissue retraction assembly (in use) forming part of a surgical access system according to the present invention;



FIG. 2 is a perspective view illustrating the components and use of an initial distraction assembly (i.e. K-wire, an initial dilating cannula with handle, and a split-dilator housed within the initial dilating cannula) forming part of the surgical access system according to the present invention, for use in distracting to a surgical target site (i.e. annulus);



FIG. 3 is a perspective view illustrating the K-wire and split-dilator of the initial distraction assembly with the initial dilating cannula and handle removed;



FIG. 4 is a posterior view of the vertebral target site illustrating the split-dilator of the present invention in use distracting in a generally cephalad-caudal fashion according to one aspect of the present invention;



FIG. 5 is a side view illustrating the use of a secondary distraction assembly (comprising a plurality of dilating cannulae over the K-wire) to further distract tissue between the skin of the patient and the surgical target site according to the present invention;



FIG. 6 is a perspective view of a retractor assembly according to the present invention, comprising a linkage assembly having three (3) retractor blades coupled thereto (posterior, cephalad, and caudal) for the purpose of creating an operative corridor to the surgical target site (shown in a first, closed position);



FIG. 7 is a perspective view of the retractor assembly of FIG. 6 in a second, opened (i.e. retracted) position according to the present invention;



FIG. 8 is a perspective view illustrating a shim introducer introducing a shim element along the interior of the posterior retractor blade such that a distal portion (shim extension) is positioned within the disc space;



FIG. 9 is a back view of a shim element according to the present invention dimensioned to be engaged with the inner surface of the posterior (and optionally anterior) retractor blade for the purpose of positioning a shim extension within the disc space, such as via the shim introducer shown in FIG. 8;



FIG. 10 is a perspective view of the retractor assembly of the present invention with the shim element disposed along the posterior retractor blade according to the present invention;



FIGS. 11-12 are perspective views of the retractor assembly of the present invention, wherein an anterior retractor blade is provided coupled to the linkage assembly via an arm assembly;



FIG. 13 is a perspective view of the retractor assembly of the present invention wherein a shim introducer is employed to introducer a shim along the anterior retractor blade according to the present invention;



FIG. 14 is a perspective view of the retractor assembly of the present invention, wherein the anterior retractor blade may be positioned at a different vertical level than the posterior, cephalad, and caudal retractor blades according to the present invention;



FIG. 15 is a perspective view of an exemplary nerve monitoring system capable of performing nerve monitoring before, during and after the creating of an operative corridor to a surgical target site using the surgical access system in accordance with the present invention;



FIG. 16 is a block diagram of the nerve monitoring system shown in FIG. 15; and



FIGS. 17-18 are screen displays illustrating exemplary features and information communicated to a user during the use of the nerve monitoring system of FIG. 15.





DESCRIPTION OF THE PREFERRED EMBODIMENT

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. It is furthermore to be readily understood that, although discussed below primarily within the context of spinal surgery, the surgical access system of the present invention may be employed in any number of anatomical settings to provide access to any number of different surgical target sites throughout the body. The surgical access system disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.


It is furthermore to be readily understood that, although discussed below primarily within the context of spinal surgery, the surgical access system and related methods of the present invention may find applicability in any of a variety of surgical and/or medical applications such that the following description relative to the spine is not to be limiting of the overall scope of the present invention. Moreover, while described below employing the nerve monitoring features described above (otherwise referred to as “nerve surveillance”) during spinal surgery, it will be appreciated that such nerve surveillance will not be required in all situations, depending upon the particular surgical target site (e.g. disk space, vertebral body, and/or internal organ), surgical approach (e.g. lateral, posterior, anterior, and/or postero-lateral approaches to the spine), and spinal level (e.g. cervical, thoracic and/or lumbar).


The present invention is directed at a novel surgical access system and related methods which involve creating and maintaining an operative corridor to the surgical target site, and optionally detecting the existence of (and optionally the distance and/or direction to) neural structures before, during and/or after this process (including the steps of distraction and/or retraction). This is accomplished by employing the following steps: (1) one or more stimulation electrodes are provided on the various distraction and/or retraction components; (2) a stimulation source (e.g. voltage or current) is coupled to the stimulation electrodes; (3) a stimulation signal is emitted from the stimulation electrodes as the various components are advanced towards or maintained at or near the surgical target site; and (4) the patient is monitored to determine if the stimulation signal causes muscles associated with nerves or neural structures within the tissue to innervate. If the nerves innervate, this may indicate that neural structures may be in close proximity to the distraction and/or retraction components.


Neural monitoring may be accomplished via any number of suitable fashions, including but not limited to observing visual twitches in muscle groups associated with the neural structures likely to found in the tissue, as well as any number of monitoring systems, including but not limited to any commercially available “traditional” electromyography (EMG) system (that is, typically operated by a neurophysiologist. Such monitoring may also be carried out via the surgeon-driven EMG monitoring system shown and described in the following commonly owned and co-pending “NeuroVision Applications” incorporated by reference into this disclosure above. In any case (visual monitoring, traditional EMG and/or surgeon-driven EMG monitoring), the access system of the present invention may advantageously be used to traverse tissue that would ordinarily be deemed unsafe or undesirable, thereby broadening the number of manners in which a given surgical target site may be accessed.


Distraction followed by retraction is advantageous because it provides the ability to more easily position an operative corridor-establishing device through tissue that is strong, thick or otherwise challenging to traverse in order to access a surgical target site. The various distraction systems of the present invention are advantageous in that they provide an improved manner of atraumatically establishing a distraction corridor prior to the use of the retraction systems of the present invention. The various retractor systems of the present invention are advantageous in that they provide an operative corridor having improved cross-sectional area and shape (including customization thereof) relative to the prior art surgical access systems. Moreover, by optionally equipping the various distraction systems and/or retraction systems with one or more electrodes, an operative corridor may be established through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient.


The present invention involves accessing a surgical target site in a fashion less invasive than traditional “open” surgeries and doing so in a manner that provides access in spite of the neural structures required to be passed through (or near) in order to establish an operative corridor to the surgical target site. Generally speaking, the surgical access system of the present invention accomplishes this by providing a tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures.


These electrodes are preferably provided for use with a nerve surveillance system such as, by way of example, the type shown and described in co-pending and commonly assigned NeuroVision PCT Applications incorporated by reference above. Generally speaking, this nerve surveillance system is capable of detecting the existence of (and optionally the distance and/or direction to) neural structures during the distraction and retraction of tissue by detecting the presence of nerves by applying a stimulation signal to such instruments and monitoring the evoked EMG signals from the myotomes associated with the nerves being passed by the distraction and retraction systems of the present invention. In so doing, the system as a whole (including the surgical access system of the present invention) may be used to form an operative corridor through (or near) any of a variety of tissues having such neural structures, particularly those which, if contacted or impinged, may otherwise result in neural impairment for the patient. In this fashion, the access system of the present invention may be used to traverse tissue that would ordinarily be deemed unsafe or undesirable, thereby broadening the number of manners in which a given surgical target site may be accessed.


The tissue distraction assembly of the present invention (comprising a K-wire, an initial dilator, and a split-dilator disposed within the initial dilator) is employed to distract the tissues extending between the skin of the patient and a given surgical target site (preferably along the posterior region of the target intervertebral disc). A secondary distraction assembly (i.e. a plurality of sequentially dilating cannulae) may optionally be employed after the initial distraction assembly to further distract the tissue. Once distracted, the resulting void or distracted region within the patient is of sufficient size to accommodate a tissue retraction assembly of the present invention. More specifically, the tissue retraction assembly (comprising a plurality of retractor blades coupled to a linkage assembly) may be advanced relative to the secondary distraction assembly such that the retractor blades, in a first, closed position, are advanced over the exterior of the secondary distraction assembly. At that point, the linkage assembly may be operated to move the retractor blades into a second, open or “retracted” position to create an operative corridor to the surgical target site.


According to one aspect of the invention, following (or before) this retraction, a posterior shim element (which is preferably slideably engaged with the posterior retractor blade) may be advanced such that a shim extension in positioned within the posterior region of the disc space. If done before retraction, this helps ensure that the posterior retractor blade will not move posteriorly during the retraction process, even though the other retractor blades (i.e. cephalad, caudal, and/or anterior retractor blades) are able to move and thereby create an operative corridor. Fixing the posterior retractor blade in this fashion helps prevent inadvertent contact with the existing nerve roots in the posterior region of the spine. The posterior shim element also helps ensure that surgical instruments employed within the operative corridor are incapable of being advanced outside the operative corridor, yet again preventing inadvertent contact with the exiting nerve roots during the surgery. Once in the appropriate anterior position, the anterior retractor blade may be locked in position and, thereafter, an anterior shim element advanced therealong for positioning a shim extension within the anterior of the disc space.


The shim elements serve to distract the adjacent vertebral bodies (thereby restoring disc height), to form protective barriers (against the migration of tissue into (or instruments out of) the operative site), and to rigidly couple the posterior and anterior retractor blades in fixed relation relative to the vertebral bodies. Once the operative corridor is established, any of a variety of surgical instruments, devices, or implants may be passed through and/or manipulated within the operative corridor depending upon the given surgical procedure.



FIG. 1 illustrates a tissue retraction assembly 10 forming part of a surgical access system according to the present invention. The retraction assembly 10 includes a posterior retractor blade 12, an anterior retractor blade 14, cephalad retractor blade 16, and caudal retractor blade 18, all of which are coupled to a linkage assembly 20. Posterior and anterior retractor blades 12, 14 establish an AP (or “width”) dimension of an operative corridor 15. Posterior retractor blade 12 and anterior retractor blade 14 are equipped with shim elements 22, 24, respectively (shown more clearly in FIG. 9). Shim elements 22, 24 serve to distract the adjacent vertebral bodies (thereby restoring disc height), form protective barriers (against the migration of tissue into (or instruments out of) the operative site), and rigidly couple the posterior and anterior retractor blades 12, 14 in fixed relation relative to the vertebral bodies. Cephalad and caudal retractor blades 16, 18 establish and maintain the “height” dimension of the operative corridor 15. Each retractor blade 12-18 (and optionally the shim elements 22, 24) may be, according to the present invention, provided with one or more electrodes 39 (preferably at their distal regions) equipped for use with a nerve surveillance system, such as, by way of example, the type shown and described in the NeuroVision PCT Applications.


The linkage assembly 20 may be coupled to any number of mechanisms for rigidly registering the linkage assembly 20 in fixed relation to the operative site, such as through the use of an articulating arm mounted to the operating table. The linkage assembly 20 includes first and second arm members 26, 28 hingedly coupled at 30. The cephalad retractor blade 16 is rigidly coupled (generally perpendicularly) to the end of the first arm member 26. The caudal retractor blade 18 is rigidly coupled (generally perpendicularly) to the end of the second arm member 28. The posterior retractor blade 12 is coupled to the linkage assembly 20 via a pivot linkage 32 (comprising a first arm 34 hingedly disposed between the posterior retractor blade 12 and the first arm member 26, and a second arm 26 hingedly disposed between the posterior retractor blade 12 and the second arm 28) such that the posterior retractor blade 12 will have a tendency to remain in the same position during the retraction process. According to one embodiment, the anterior retractor blade 14 may be coupled to the linkage assembly 20 via an arm assembly 38.



FIG. 2 illustrates an initial distraction assembly 40 forming part of the surgical access system according to the present invention. The initial distraction assembly 40 includes a K-wire 42, an initial dilating cannula 44 with handle 46, and a split-dilator 48 housed within the initial dilating cannula 44. In use, the K-wire 42 and split-dilator 48 are disposed within the initial dilating cannula 44 and the entire assembly 40 advanced through the tissue towards the surgical target site (i.e. annulus). Again, this is preferably accomplished while employing the nerve detection and/or direction features described above. After the initial dilating assembly 40 is advanced such that the distal ends of the split-dilator 48 and initial dilator 44 are positioned within the disc space (FIG. 2), the initial dilator 44 and handle 46 are removed (FIG. 3) to thereby leave the split-dilator 48 and K-wire 42 in place. As shown in FIG. 4, the split-dilator 48 is thereafter split such that the respective halves 48a, 48b are separated from one another to distract tissue in a generally cephalad-caudal fashion relative to the target site. The split dilator 48 may thereafter be relaxed (allowing the dilator halves 48a, 48b to come together) and rotated such that the dilator halves 48a, 48b are disposed in the anterior-posterior plane. Once rotated in this manner, the dilator halves 48a, 48b are again separated to distract tissue in a generally anterior-posterior fashion. Each dilator halve 48a, 48b may be, according to the present invention, provided with one or more electrodes (preferably at their distal regions) equipped for use with a nerve surveillance system, such as, by way of example, the type shown and described in the NeuroVision PCT Applications.


Following this initial distraction, a secondary distraction may be optionally undertaken, such as via a sequential dilation system 50 as shown in FIG. 5. According to the present invention, the sequential dilation system 50 may include the K-wire 42, the initial dilator 44, and one or more supplemental dilators 52, 54 for the purpose of further dilating the tissue down to the surgical target site. Once again, each component of the secondary distraction assembly 50 (namely, the K-wire 42, the initial dilator 44, and the supplemental dilators 52, 54 may be, according to the present invention, provided with one or more electrodes (preferably at their distal regions) equipped for use with a nerve surveillance system, such as, by way of example, the type shown and described in the NeuroVision PCT Applications.


As shown in FIG. 6, the retraction assembly 10 of the present invention is thereafter advanced along the exterior of the sequential dilation system 50. This is accomplished by maintaining the retractor blades 12-16 in a first, closed position (with the retractor blades 12-16 in generally abutting relation to one another). Once advanced to the surgical target site, the linkage assembly 20 may be operated as shown in FIG. 7 to move the retractor blades 12-16 into a second, open or “retracted” position. As one can see, the posterior retractor blade 12 is allowed to stay in the same general position during this process, such that the cephalad and caudal retractor blades 14, 16 move away from the posterior retractor blade 12. Again, this is accomplished through the use of the pivot linkage 32 between the posterior retractor blade 12 and the arms 26, 28 of the linkage assembly 20.


At this point, as shown in FIG. 8, the posterior shim element 22 (FIG. 9) may be advanced along an engagement slot formed along the interior surface of the posterior retractor blade 12 such that the shim extension (distal end) is positioned in the posterior region of the disc space as shown in FIG. 10. To aid in this process, a shim introducer 60 may be provided, which includes a handle member 62 and an elongate portion 64 capable of delivering the shim element 22 along the interior of the posterior retractor blade 12 and thereafter selectively disengaging the shim element 22 so as to remove the elongate portion 64 from the operative site. As shown in FIGS. 11-12, the anterior retractor blade 14 may thereafter be positioned relative to the posterior, cephalad, and caudal retractor blades 12, 16, 18, respectively, by virtue of the arm assembly 38. The anterior shim element 24 may thereafter be advanced along the anterior retractor blade 14 such that the shim extension (distal region thereof) extends into the anterior region of the disc space as shown in FIG. 13. The end result is shown in FIG. 14, with the retraction assembly 10 of the present invention disposed in position over a surgical target site.



FIGS. 15-16 illustrate, by way of example only, a surgical system 120 provided in accordance with a broad aspect of the present invention. The surgical system 120 includes a control unit 122, a patient module 124, an EMG harness 126 and return electrode 128 coupled to the patient module 124, and an accessory cable 132 in combination with a handle assembly 136. The handle assembly 136 includes one or more electrical connectors 130, including (by way of example only) a pin connector 134, a pin connector 138, and a clamping-style connector 135. As shown in dotted lines, each of the electrical connectors 130 may be coupled to the handle assembly 136 and include a manner of establishing electrical communications with any of the electrodes 39 provided on the distraction and/or retraction assemblies of the present invention, including the shims 22, 24 (collectively “Surgical Access Instruments”). By establishing electrical communication in this fashion, the handle assembly 136 may be employed to selectively apply a stimulation signal to any of the Surgical Access Instruments to detect the presence of (and optionally direction to) neural structures during and/or after the distraction and retraction steps of the present invention.


The control unit 122 includes a touch screen display 140 and a base 142, which collectively contain the essential processing capabilities for controlling the surgical system 120. The patient module 124 is connected to the control unit 122 via a data cable 144, which establishes the electrical connections and communications (digital and/or analog) between the control unit 122 and patient module 124. The main functions of the control unit 122 include receiving user commands via the touch screen display 140, activating stimulation, processing signal data according to defined algorithms (described below), displaying received parameters and processed data, and monitoring system status and reporting fault conditions. The touch screen display 140 is preferably equipped with a graphical user interface (GUI) capable of communicating information to the user and receiving instructions from the user. The display 140 and/or base 142 may contain patient module interface circuitry that commands the stimulation sources, receives digitized signals and other information from the patient module 124, processes the EMG responses to extract characteristic information for each muscle group, and displays the processed data to the operator via the display 140.


The accessory handle assembly 136 includes a cable 155 for establishing electrical communication with the patient module 124 (via the accessory cable 132). In a preferred embodiment, each electrical connector 130 includes a proximal electrical connector 156 and an electrical cable 157 for establishing electrical communication between the handle assembly 136 and the electrical connectors 134, 138, and 135. The proximal electrical connector 156 may be designed to thread and/or snap into engagement with the distal end 159 of the handle assembly 136. In this fashion, the Surgical Access Instruments may be quickly and easily coupled (electrically and mechanically) to the accessory handle assembly 136. The pin connectors 134 and 138 may be designed to engage with electrical mating portions provided on the Surgical Access Instruments, wherein these electrical mating portions are in turn electrically coupled to the electrodes 39. The distal electrical connector of the clamp-type coupler 135 may include any number of suitable electrode or electrode regions (including protrusions) on or about the distal (or pinching) ends of the clamp arms 161 forming the coupler 135. Corresponding regions (such as electrodes or electrode regions—including indentations) may be provided on the Surgical Access Instruments (including K-wire 42) according to the present invention.


In all situations, the user may operate one or more buttons of the handle assembly 136 to selectively initiate a stimulation signal (preferably, a current signal) from the patient module 124 to one of the electrical connectors 130, and hence the electrodes 39 on the distraction and retraction assemblies of the present invention. By monitoring the myotomes associated with the nerve roots (via the EMG harness 126 and recording electrode 127) and assessing the resulting EMG responses (via the control unit 122), the surgical system 120 can detect the presence of (and optionally the direction to) neural structures during and after the distraction and/or retraction according to the present invention.


In one embodiment, the monitoring system 120 is capable of determining nerve presence and/or direction relative to one or more of the K-wire 42, dilating cannula 44, split-retractor 48, retractor blades 12-18, and/or the shim elements 22, 24 before, during and/or following the creation of an operative corridor to a surgical target site. Monitoring system 120 accomplishes this by having the control unit 122 and patient module 124 cooperate to send electrical stimulation signals to one or more of the stimulation electrodes provided on these Surgical Access Instruments. Depending upon the location within a patient (and more particularly, to any neural structures), the stimulation signals may cause nerves adjacent to or in the general proximity of the Surgical Access Instruments to depolarize. This causes muscle groups to innervate and generate EMG responses, which can be sensed via the EMG harness 126. The nerve direction feature of the system 120 is based on assessing the evoked response of the various muscle myotomes monitored by the system 120 via the EMG harness 126.


By monitoring the myotomes associated with the nerves (via the EMG harness 126 and recording electrode 127) and assessing the resulting EMG responses (via the control unit 122), the surgical access system of the present invention is capable of detecting the presence of (and optionally the distant and/or direction to) such nerves. This provides the ability to actively negotiate around or past such nerves to safely and reproducibly form the operative corridor to a particular surgical target site, as well as monitor to ensure that no neural structures migrate into contact with the retraction assembly 10 after the operative corridor has been established. In spinal surgery, for example, this is particularly advantageous in that the surgical access system of the present invention may be particularly suited for establishing an operative corridor to an intervertebral target site in a postero-lateral, trans-psoas fashion so as to avoid the bony posterior elements of the spinal column.



FIGS. 17-18 are exemplary screen displays (to be shown on the display 140) illustrating one embodiment of the nerve direction feature of the monitoring system shown and described with reference to FIGS. 15-16. These screen displays are intended to communicate a variety of information to the surgeon in an easy-to-interpret fashion. This information may include, but is not necessarily limited to, a display of the function 180 (in this case “DIRECTION”), a graphical representation of a patient 181, the myotome levels being monitored 182, the nerve or group associated with a displayed myotome 183, the name of the instrument being used 184 (e.g. dilating cannula 44), the size of the instrument being used 185, the stimulation threshold current 186, a graphical representation of the instrument being used 187 (in this case, a cross-sectional view of a dilating cannula 44) to provide a reference point from which to illustrate relative direction of the instrument to the nerve, the stimulation current being applied to the stimulation electrodes 188, instructions for the user 189 (in this case, “ADVANCE” and/or “HOLD”), and (in FIG. 19) an arrow 190 indicating the direction from the instrument to a nerve. This information may be communicated in any number of suitable fashions, including but not limited to the use of visual indicia (such as alpha-numeric characters, light-emitting elements, and/or graphics) and audio communications (such as a speaker element). Although shown with specific reference to a dilating cannula (such as at 184), it is to be readily appreciated that the present invention is deemed to include providing similar information on the display 140 during the use of any or all of the various Surgical Access Instruments of the present invention, including the initial distraction assembly 40 (i.e. the K-wire 42, dilating cannula 44, and split dilator 48), the secondary distraction assembly 50, and/or the retractor blades 12-18 and/or shim elements 22, 24 of the retraction assembly 10.


The retractor blades 12-18 and the shim elements 22, 24 of the present invention may also be provided with one or more electrodes for use in providing the neural monitoring capabilities of the present invention. By way of example only, it may be advantageous to provide one or more electrodes on these components (preferably on the side facing away from the surgical target site) for the purpose of conducting neural monitoring before, during and/or after the retractor blades 12-18 and/or shim elements 22, 24 have been positioned at or near the surgical target site.


The surgical access system of the present invention may be sold or distributed to end users in any number of suitable kits or packages (sterile and/or non-sterile) containing some or all of the various components described herein. For example, the retraction assembly 10 may be provided such that the mounting assembly 20 is reusable (e.g., autoclavable), while the retractor blades 12-18 and/or shim elements 22, 24 are disposable. In a further embodiment, an initial kit may include these materials, including a variety of sets of retractor blades 12-18 and/or shim elements 22, 24 (and extensions 80) having varying (or “incremental”) lengths to account for surgical target sites of varying locations within the patient, optionally color-coded to designate a predetermined length.


As evident from the above discussion and drawings, the present invention accomplishes the goal of providing a novel surgical access system and related methods which involve creating a distraction corridor to a surgical target site, thereafter retracting the distraction corridor to establish and maintain an operative corridor to the surgical target site, and optionally detecting the existence of (and optionally the distance and/or direction to) neural structures before, during and/or after the formation of the distraction and/or operative corridors.


The surgical access system of the present invention can be used in any of a wide variety of surgical or medical applications, above and beyond the spinal applications discussed herein. By way of example only, in spinal applications, any number of implants and/or instruments may be introduced through the operative corridor, including but not limited to spinal fusion constructs (such as allograft implants, ceramic implants, cages, mesh, etc.), fixation devices (such as pedicle and/or facet screws and related tension bands or rod systems), and any number of motion-preserving devices (including but not limited to nucleus replacement and/or total disc replacement systems).


While certain embodiments have been described, 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 present application. For example, with regard to the monitoring system 120, it may be implemented using any combination of computer programming software, firmware or hardware. As a preparatory act to practicing the system 120 or constructing an apparatus according to the application, the computer programming code (whether software or firmware) according to the application will typically be stored in one or more machine readable storage mediums such as fixed (hard) drives, diskettes, optical disks, magnetic tape, semiconductor memories such as ROMs, PROMs, etc., thereby making an article of manufacture in accordance with the application. The article of manufacture containing the computer programming code may be used by either executing the code directly from the storage device, by copying the code from the storage device into another storage device such as a hard disk, RAM, etc. or by transmitting the code on a network for remote execution. As can be envisioned by one of skill in the art, many different combinations of the above may be used and accordingly the present application is not limited by the scope of the appended claims.

Claims
  • 1. A method of forming an operating corridor to a lumbar spine of a patient, the patient having an anterior aspect, a posterior aspect and two lateral aspects, the method comprising: inserting at least one dilator into the patient at an insertion position on one of the two lateral aspects of the patient;advancing the at least one dilator toward a target intervertebral disc of the lumbar spine, along a lateral, trans-psoas path having a path axis that extends from the insertion position on the one of the two lateral aspects to the other of the two lateral aspects of the patient;delivering electrical stimulation signals from a first stimulation electrode disposed at a distal region of the at least one dilator while the at least one dilator is advancing along the lateral, trans-psoas path;advancing an elongate penetration member extending through the at least one dilator into the target intervertebral disc;delivering three retractor blades of a retractor assembly in a closed position over an outermost dilator of the at least one dilator along the lateral, trans-psoas path;removing the at least one dilator from the lateral aspect of the target intervertebral disc of the lumbar spine after the three retractor blades are positioned along the lateral, trans-psoas path;advancing a shim device along a first retractor blade of the three retractor blades to a position in which a portion of the shim device extends from the first retractor blade and to the target intervertebral disc; andadjusting the retractor assembly to move second and third retractor blades of the three retractor blades to an open position such that the three retractor blades form a non-enclosed operating corridor to the target intervertebral disc of the lumbar spine.
  • 2. The method of claim 1, further comprising actuating a blade holder assembly of the retractor assembly to adjust the retractor assembly from the closed position to the open position.
  • 3. The method of claim 2, wherein the three retractor blades extend generally perpendicularly relative to arm portions of the blade holder assembly.
  • 4. The method of claim 1, wherein the elongate penetration member is delivered together with the at least one dilator along the lateral, trans-psoas path.
  • 5. The method of claim 4, wherein the elongate penetration member comprises a K-wire.
  • 6. The method of claim 1, further comprising: delivering a fourth retractor blade along the lateral, trans-psoas path after adjusting the retractor assembly to the open position and coupling the fourth retractor blade to the retractor assembly.
  • 7. The method of claim 6, wherein the fourth retractor blade is positioned to be an anterior retractor blade along the lateral, trans-psoas path.
  • 8. The method of claim 1, wherein the shim device includes a proximal portion configured to releasably attach to the first retractor blade and a distal extension configured to penetrate into the target intervertebral disc.
  • 9. The method of claim 8, wherein the proximal portion includes a rearwardly extending ridge structure to releasably engage with a corresponding groove along an interior face of the first retractor blade when the shim device is advanced along the first retractor blade.
  • 10. The method of claim 8, wherein the shim device has a maximum longitudinal length extending from a proximal-most end of the proximal portion to a distal-most end of the distal extension and extending parallel to a longitudinal axis of the shim device, wherein the maximum longitudinal length of the shim device is less than a maximum longitudinal length of the first retractor blade.
  • 11. The method of claim 10, wherein the distal extension includes a maximum lateral width located proximally away from a distal-most end of the distal extension, the proximal portion having a proximal lateral width that is greater than the maximum lateral width of the distal extension.
  • 12. The method of claim 11, wherein the distal-most end of the distal extension includes a tapered tip region.
  • 13. The method of claim 1, wherein adjusting the retractor assembly includes pivoting a first pivot arm coupled to the second retractor blade and pivoting a second pivot arm coupled to the third retractor blade.
  • 14. The method of claim 1, further comprising: delivering electrical stimulation signals from a second stimulation electrode at a distal region of a second dilator of the at least one dilator while the second dilator is advanced along the lateral, trans-psoas path.
  • 15. The method of claim 1, further comprising: electrically connecting a cable of a nerve monitoring system to a first proximal connector portion of the at least one dilatordelivering, with the nerve monitoring system, an electrical stimulation signal to the first stimulation electrode of the at least one dilator during advancement of the at least one dilator along the lateral, trans-psoas path to the targeted intervertebral disc of the lumbar spine;monitoring, with the nerve monitoring system, muscle activity detected by a set of sensor electrodes in communication with leg muscles associated with nerves in psoas muscle tissue of the patient; anddisplaying, with the nerve monitoring system, a numeric stimulation current threshold required to obtain the detected muscle activity in at least one of said leg muscles during advancement of the at least one dilator.
  • 16. The method of claim 15, wherein the muscle activity is detected with electromyography (EMG) sensors.
  • 17. The method of claim 1, further comprising: after adjusting the retractor assembly to form the operating corridor, passing an implant through the operative corridor along the lateral, trans-psoas path.
CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 15/792,652, pending, filed Oct. 24, 2017, which is a continuation of U.S. patent application Ser. No. 15/058,083, (now U.S. Pat. No. 9,795,371), filed Mar. 1, 2016, which is a continuation of U.S. patent application Ser. No. 14/287,982, (now U.S. Pat. No. 9,301,743), filed May 27, 2014, which is a continuation of U.S. patent application Ser. No. 14/018,209, (now U.S. Pat. No. 8,747,307), filed Sep. 4, 2013, which is a continuation of U.S. patent application Ser. No. 13/856,648 (now U.S. Pat. No. 8,602,982), filed Apr. 4, 2013, which is a division of U.S. patent application Ser. No. 13/756,883 (now U.S. Pat. No. 8,562,521), filed Feb. 1, 2013, which is a continuation of U.S. patent application Ser. No. 13/466,531 (now U.S. Pat. No. 8,523,768), filed May 8, 2012, which is a continuation of U.S. patent application Ser. No. 13/417,499 (now U.S. Pat. No. 8,343,046), filed Mar. 12, 2012, which is a continuation of U.S. patent application Ser. No. 12/650,301 (now U.S. Pat. No. 8,133,173), filed Dec. 30, 2009, which is a continuation of U.S. patent application Ser. No. 12/636,860 (now U.S. Pat. No. 8,403,841), filed Dec. 14, 2009, which is a continuation of U.S. patent application Ser. No. 10/759,811 (now U.S. Pat. No. 7,691,057), filed Jan. 16, 2004, which claims priority to U.S. Provisional Patent Application Ser. No. 60/440,905, filed Jan. 16, 2003, the entire contents of these applications are hereby expressly incorporated by reference into this disclosure as if set forth fully herein. The present application also incorporates by reference the following commonly owned patent applications in their entireties (collectively, the “NeuroVision Applications”): PCT App. Ser. No. PCT/US02/22247, entitled “System and Methods for Determining Nerve Proximity, Direction, and Pathology During Surgery,” filed on Jul. 11, 2002; PCT App. Ser. No. PCT/US02/30617, entitled “System and Methods for Performing Surgical Procedures and Assessments,” filed on Sep. 25, 2002; PCT App. Ser. No. PCT/US02/35047, entitled “System and Methods for Performing Percutaneous Pedicle Integrity Assessments,” filed on Oct. 30, 2002; PCT App. Ser. No. PCT/US03/02056, entitled “System and Methods for Determining Nerve Direction to a Surgical Instrument,” filed Jan. 15, 2003 (collectively “NeuroVision PCT Applications”).

US Referenced Citations (563)
Number Name Date Kind
208227 Dorr Sep 1878 A
509226 Kellogg Nov 1893 A
972983 Arthur Oct 1910 A
1003232 Ferdinando Sep 1911 A
1044348 Ferdinando Nov 1912 A
1328624 Graham Jan 1920 A
1548184 Cameron Aug 1925 A
1919120 O'connor et al. Jul 1933 A
2594086 Smith Apr 1952 A
2704061 Amspacker Mar 1955 A
2704064 Fizzell et al. Mar 1955 A
2736002 Oriel Feb 1956 A
2808826 Reiner et al. Oct 1957 A
2840082 Salvatore Jun 1958 A
3364929 Ide et al. Jan 1968 A
3664329 Naylor May 1972 A
3682162 Colyer Aug 1972 A
3740839 Otte et al. Jun 1973 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 Pelzner et al. Aug 1979 A
4207897 Evatt 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 Heule 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
4545373 Christoudias Oct 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 et al. Jan 1987 A
4658835 Pohndorf Apr 1987 A
D295445 Freeman et al. 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
4817587 Janese 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
4945896 Gade Aug 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
5178133 Pena Jan 1993 A
5190561 Graber Mar 1993 A
5192327 Brantigan Mar 1993 A
5195541 Obenchain Mar 1993 A
5196015 Neubardt Mar 1993 A
5215100 Spitz et al. Jun 1993 A
5231974 Giglio et al. Aug 1993 A
RE34390 Culver et al. Sep 1993 E
D340521 Heinzelman et al. Oct 1993 S
5255691 Otten Oct 1993 A
5261918 Phillips et al. Nov 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
5425772 Brantigan Jun 1995 A
5433739 Sluijter et al. Jul 1995 A
5450845 Axelgaard Sep 1995 A
5458638 Kuslich et al. Oct 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
5545222 Bonutti Aug 1996 A
5549656 Reiss Aug 1996 A
5560372 Cory Oct 1996 A
5562736 Ray et al. Oct 1996 A
5566678 Cadwell et al. 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
5653761 Pisharodi Aug 1997 A
5653762 Pisharodi Aug 1997 A
5667508 Errico et al. Sep 1997 A
5669909 Zdeblick 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
5716415 Steffee Feb 1998 A
5720751 Jackson Feb 1998 A
5728046 Mayer et al. Mar 1998 A
5728159 Stroever 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
5766252 Henry et al. 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 et al. Jul 1998 A
5792044 Foley et al. Aug 1998 A
5797854 Hedgecock Aug 1998 A
5797909 Michelson Aug 1998 A
5800550 Sertich Sep 1998 A
5813978 Jako Sep 1998 A
5814073 Bonutti Sep 1998 A
5814084 Grivas et al. Sep 1998 A
5830151 Hadzic et al. Nov 1998 A
5851191 Gozani Dec 1998 A
5851208 Trott Dec 1998 A
5853373 Griffith et al. Dec 1998 A
5860973 Michelson Jan 1999 A
5862314 Jeddeloh Jan 1999 A
5865845 Thalgott Feb 1999 A
5872314 Clinton Feb 1999 A
5885210 Cox Mar 1999 A
5885219 Nightengale Mar 1999 A
5888196 Bonutti Mar 1999 A
5888224 Beckers et al. Mar 1999 A
5891147 Moskovitz et al. Apr 1999 A
5893890 Pisharodi Apr 1999 A
5902231 Foley et al. May 1999 A
5910315 Stevenson et al. Jun 1999 A
5928139 Koros et al. Jul 1999 A
5928158 Aristides Jul 1999 A
5931777 Sava Aug 1999 A
5935131 Bonutti Aug 1999 A
5938688 Schiff Aug 1999 A
5944658 Koros et al. Aug 1999 A
5954769 Rosenlicht Sep 1999 A
5968098 Winslow Oct 1999 A
5976094 Gozani Nov 1999 A
5976146 Ogawa et al. Nov 1999 A
5993474 Ouchi Nov 1999 A
6004262 Putz et al. Dec 1999 A
6004312 Finneran et al. Dec 1999 A
6004326 Castro et al. Dec 1999 A
6007487 Foley et al. Dec 1999 A
6008433 Stone Dec 1999 A
6010520 Pattison Jan 2000 A
6015436 Schoenhoeffer Jan 2000 A
6024696 Hoftman et al. Feb 2000 A
6024697 Pisarik Feb 2000 A
6027456 Feler et al. Feb 2000 A
6033405 Winslow et al. Mar 2000 A
6036638 Nwawka Mar 2000 A
6038469 Karlsson et al. Mar 2000 A
6038477 Kayyali Mar 2000 A
6039761 Li et al. Mar 2000 A
6042582 Ray Mar 2000 A
6045580 Scarborough et al. Apr 2000 A
6048342 Zucherman et al. Apr 2000 A
6050992 Nichols Apr 2000 A
6059829 Schlaepfer et al. May 2000 A
6063088 Winslow May 2000 A
6074343 Nathanson et al. Jun 2000 A
6080105 Spears Jun 2000 A
6083154 Liu et al. Jul 2000 A
6083225 Winslow et al. Jul 2000 A
6095987 Shmulewitz et al. Aug 2000 A
6096080 Nicholson et al. Aug 2000 A
6104957 Alo et al. Aug 2000 A
6104960 Duysens et al. Aug 2000 A
6113638 Williams et al. Sep 2000 A
6120503 Michelson Sep 2000 A
6120506 Kohrs et al. 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
6142931 Kaji Nov 2000 A
6146335 Gozani Nov 2000 A
6152871 Foley et al. Nov 2000 A
6159179 Simonson Dec 2000 A
6159211 Boriani et al. Dec 2000 A
6159215 Urbahns et al. Dec 2000 A
6159230 Samuels Dec 2000 A
6161047 King et al. Dec 2000 A
6174311 Branch et al. Jan 2001 B1
6181961 Prass Jan 2001 B1
6187000 Davison et al. Feb 2001 B1
6193756 Studer et al. Feb 2001 B1
6196969 Bester et al. Mar 2001 B1
6200347 Anderson et al. Mar 2001 B1
6206826 Mathews et al. Mar 2001 B1
6206922 Zdeblick et al. Mar 2001 B1
6217509 Foley et al. Apr 2001 B1
6224545 Cocchia et al. May 2001 B1
6224549 Drongelen May 2001 B1
6224607 Michelson May 2001 B1
6224631 Kohrs May 2001 B1
6241771 Gresser et al. Jun 2001 B1
6245082 Gellman et al. Jun 2001 B1
6251140 Marino et al. Jun 2001 B1
6258125 Paul et al. Jul 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
6277149 Boyle et al. 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
6319257 Carignan et al. 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
6371989 Chauvin et al. Apr 2002 B1
6383221 Scarborough et al. May 2002 B1
6395007 Bhatnagar et al. May 2002 B1
6409766 Brett Jun 2002 B1
6416465 Brau Jul 2002 B2
6425859 Foley et al. Jul 2002 B1
6425887 McGuckin et al. Jul 2002 B1
6425901 Zhu et al. Jul 2002 B1
6432048 Francois Aug 2002 B1
6432140 Lin Aug 2002 B1
6440142 Ralph et al. Aug 2002 B1
6442814 Landry et al. Sep 2002 B1
6450952 Rioux et al. Sep 2002 B1
6451015 Rittman, III Sep 2002 B1
6454806 Cohen 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
6468311 Boyd et al. Oct 2002 B2
6491724 Ferree Dec 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
D472634 Anderson Apr 2003 S
D472650 Green Apr 2003 S
6564078 Marino et al. May 2003 B1
6579244 Goodwin Jun 2003 B2
6595998 Johnson et al. Jul 2003 B2
6599294 Fuss et al. Jul 2003 B2
6620157 Dabney et al. Sep 2003 B1
6626905 Schmiel et al. Sep 2003 B1
6635086 Lin Oct 2003 B2
6645194 Briscoe et al. Nov 2003 B2
6648895 Burkus et al. Nov 2003 B2
6672019 Wenz et al. Jan 2004 B1
6676703 Biscup Jan 2004 B2
6679833 Smith et al. Jan 2004 B2
6706067 Shimp et al. Mar 2004 B2
6719692 Kleffner et al. Apr 2004 B2
6746484 Liu et al. Jun 2004 B1
6755841 Fraser et al. Jun 2004 B2
6760616 Hoey et al. Jul 2004 B2
6761739 Shepard 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
6824564 Crozet Nov 2004 B2
6829508 Schulman et al. Dec 2004 B2
6830570 Frey et al. Dec 2004 B1
6847849 Mamo et al. Jan 2005 B2
6849047 Goodwin Feb 2005 B2
6855105 Jackson et al. Feb 2005 B2
6869398 Obenchain et al. Mar 2005 B2
6871099 Whitehurst et al. Mar 2005 B1
D503801 Jackson Apr 2005 S
6902569 Parmer et al. Jun 2005 B2
6916330 Simonson Jul 2005 B2
6926728 Zucherman et al. Aug 2005 B2
6929606 Ritland Aug 2005 B2
6942698 Jackson Sep 2005 B1
6945933 Branch et al. Sep 2005 B2
6951538 Ritland Oct 2005 B2
6964687 Bernard et al. Nov 2005 B1
6979353 Bresina Dec 2005 B2
6984245 McGahan et al. Jan 2006 B2
6986788 Paul et al. Jan 2006 B2
6989031 Michelson Jan 2006 B2
7018416 Hanson et al. Mar 2006 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
D530423 Miles et al. Oct 2006 S
7166113 Arambula et al. Jan 2007 B2
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
7470236 Kelleher et al. Dec 2008 B1
7473222 Dewey et al. Jan 2009 B2
7481766 Lee et al. Jan 2009 B2
7522953 Gharib 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
7892173 Miles et al. Feb 2011 B2
7905840 Pimenta et al. Mar 2011 B2
7918891 Curran et al. Apr 2011 B1
7920922 Kaula et al. Apr 2011 B2
7935051 Miles et al. May 2011 B2
7962191 Marino et al. Jun 2011 B2
7963927 Kelleher et al. Jun 2011 B2
7991463 Kelleher et al. Aug 2011 B2
8000782 Gharib et al. Aug 2011 B2
8005535 Gharib et al. Aug 2011 B2
8016767 Miles et al. Sep 2011 B2
8021430 Michelson Sep 2011 B2
8055349 Kaula et al. Nov 2011 B2
8068912 Gharib et al. Nov 2011 B2
8114019 Miles et al. Feb 2012 B2
8133173 Miles et al. Mar 2012 B2
8137284 Miles et al. Mar 2012 B2
8172750 Miles et al. May 2012 B2
8182423 Miles et al. May 2012 B2
8187179 Miles et al. May 2012 B2
8187334 Curran et al. May 2012 B2
8192356 Miles et al. Jun 2012 B2
8192357 Miles et al. Jun 2012 B2
8244343 Gharib et al. Aug 2012 B2
8246686 Curran et al. Aug 2012 B1
8251997 Michelson Aug 2012 B2
8303458 Fukano et al. Nov 2012 B2
8303498 Miles et al. Nov 2012 B2
8303515 Pimenta et al. Nov 2012 B2
8337410 Kelleher et al. Dec 2012 B2
8343046 Miles et al. Jan 2013 B2
8343224 Lynn et al. Jan 2013 B2
8355780 Miles et al. Jan 2013 B2
8361156 Curran et al. Jan 2013 B2
8388527 Miles et al. Mar 2013 B2
8403841 Miles et al. Mar 2013 B2
8439832 Miles et al. May 2013 B2
8489170 Marino et al. Jul 2013 B2
8500634 Miles et al. Aug 2013 B2
8512235 Miles et al. Aug 2013 B2
8523768 Miles et al. Sep 2013 B2
8548579 Gharib et al. Oct 2013 B2
8550994 Miles et al. Oct 2013 B2
8556808 Miles et al. Oct 2013 B2
8562521 Miles et al. Oct 2013 B2
8574301 Curran et al. Nov 2013 B2
8591432 Pimenta et al. Nov 2013 B2
8602982 Miles et al. Dec 2013 B2
8608804 Curran et al. Dec 2013 B2
8628469 Miles et al. Jan 2014 B2
8634904 Kaula et al. Jan 2014 B2
8663100 Miles et al. Mar 2014 B2
8672840 Miles et al. Mar 2014 B2
8673005 Pimenta et al. Mar 2014 B1
8679006 Miles et al. Mar 2014 B2
8685105 Curran et al. Apr 2014 B2
8696559 Miles et al. Apr 2014 B2
8708899 Miles et al. Apr 2014 B2
8738123 Gharib et al. May 2014 B2
8740783 Gharib et al. Jun 2014 B2
8747307 Miles et al. Jun 2014 B2
8753270 Miles et al. Jun 2014 B2
8753271 Miles et al. Jun 2014 B1
8764649 Miles et al. Jul 2014 B2
8768450 Gharib et al. Jul 2014 B2
8780899 Tillman et al. Jul 2014 B2
8812116 Kaula et al. Aug 2014 B2
8814940 Curran et al. Aug 2014 B2
8821396 Miles et al. Sep 2014 B1
8915846 Miles et al. Dec 2014 B2
8942801 Miles et al. Jan 2015 B2
8945004 Miles et al. Feb 2015 B2
8956283 Miles et al. Feb 2015 B2
8958869 Kelleher et al. Feb 2015 B2
8977352 Gharib et al. Mar 2015 B2
9014776 Marino et al. Apr 2015 B2
9037250 Kaula et al. May 2015 B2
9180021 Curran et al. Nov 2015 B2
9186261 Pimenta et al. Nov 2015 B2
9204871 Miles et al. Dec 2015 B2
9265493 Miles et al. Feb 2016 B2
9301743 Miles et al. Apr 2016 B2
9314152 Pimenta et al. Apr 2016 B2
9387090 Arnold et al. Jul 2016 B2
9456783 Kaula et al. Oct 2016 B2
9468405 Miles et al. Oct 2016 B2
9474627 Curran et al. Oct 2016 B2
9486329 Pimenta et al. Nov 2016 B2
9572562 Miles et al. Feb 2017 B2
9610071 Miles et al. Apr 2017 B2
9636233 Arnold et al. May 2017 B2
20010037123 Hancock Nov 2001 A1
20010039949 Loubser Nov 2001 A1
20010056280 Underwood et al. Dec 2001 A1
20020007129 Marino Jan 2002 A1
20020010392 Desai Jan 2002 A1
20020016592 Branch et al. Feb 2002 A1
20020065481 Cory et al. May 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
20020147387 Paolitto et al. Oct 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
20030105528 Shimp et al. Jun 2003 A1
20030109928 Pasquet et al. 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
20040181165 Hoey et al. Sep 2004 A1
20040199084 Kelleher et al. Oct 2004 A1
20040225228 Ferree Nov 2004 A1
20040230191 Frey et al. Nov 2004 A1
20050004593 Simonson Jan 2005 A1
20050004623 Miles et al. Jan 2005 A1
20050033380 Tanner et al. Feb 2005 A1
20050060006 Pflueger et al. Mar 2005 A1
20050075578 Gharib et al. Apr 2005 A1
20050080320 Lee et al. Apr 2005 A1
20050149035 Pimenta et al. Jul 2005 A1
20050149054 Gorek Jul 2005 A1
20050182454 Gharib et al. Aug 2005 A1
20050192575 Pacheco Sep 2005 A1
20050203538 Lo et al. Sep 2005 A1
20050228232 Gillinov et al. Oct 2005 A1
20050277812 Myles Dec 2005 A1
20060025703 Miles et al. Feb 2006 A1
20060052826 Kim et al. Mar 2006 A1
20060052828 Kim et al. Mar 2006 A1
20060069315 Miles et al. Mar 2006 A1
20060224078 Hoey et al. Oct 2006 A1
20060235529 Ralph et al. Oct 2006 A1
20060247658 Pond et al. Nov 2006 A1
20070016097 Farquhar et al. Jan 2007 A1
20070049931 Justis et al. Mar 2007 A1
20070049962 Marino et al. Mar 2007 A1
20070072475 Justin et al. Mar 2007 A1
20070100212 Pimenta et al. May 2007 A1
20070198062 Miles et al. Aug 2007 A1
20070208228 Pavento et al. Sep 2007 A1
20070260317 Ankney et al. Nov 2007 A1
20070270842 Bankoski et al. Nov 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
20080065135 Marino et al. Mar 2008 A1
20080065144 Marino et al. Mar 2008 A1
20080065178 Kelleher et al. Mar 2008 A1
20080071191 Kelleher et al. Mar 2008 A1
20080077138 Cohen et al. Mar 2008 A1
20080097164 Miles et al. Apr 2008 A1
20080103601 Biro et al. May 2008 A1
20080146885 Protopsaltis Jun 2008 A1
20080183214 Copp et al. Jul 2008 A1
20080221394 Melkent et al. Sep 2008 A1
20080288077 Reo et al. Nov 2008 A1
20080300465 Feigenwinter et al. Dec 2008 A1
20090030519 Falahee Jan 2009 A1
20090124860 Miles et al. May 2009 A1
20090132049 Carver et al. May 2009 A1
20090138050 Ferree May 2009 A1
20090138090 Hurlbert et al. May 2009 A1
20090192403 Gharib et al. Jul 2009 A1
20090204016 Gharib et al. Aug 2009 A1
20100069783 Miles et al. Mar 2010 A1
20100106251 Kast Apr 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 et al. Jul 2010 A1
20100174148 Miles et al. Jul 2010 A1
20100228350 Gornet et al. Sep 2010 A1
20110046448 Paolitto et al. Feb 2011 A1
20110218631 Woodburn, Sr. et al. Sep 2011 A1
20110313530 Gharib et al. Dec 2011 A1
20120238822 Miles et al. Sep 2012 A1
20120238893 Farquhar et al. Sep 2012 A1
20130331943 Arnold et al. Dec 2013 A1
20140235950 Miles et al. Aug 2014 A1
20140288374 Miles et al. Sep 2014 A1
20140288375 Miles et al. Sep 2014 A1
20150150693 Gharib et al. Jun 2015 A1
20150157227 Kelleher et al. Jun 2015 A1
20150157228 Marino et al. Jun 2015 A1
20150282948 Arnold et al. Oct 2015 A1
20160120530 Miles et al. May 2016 A1
20160174958 Miles et al. Jun 2016 A1
20160174959 Miles et al. Jun 2016 A1
20160192921 Pimenta et al. Jul 2016 A1
20160374613 Kaula et al. Dec 2016 A1
20170007421 Curran et al. Jan 2017 A1
20170020503 Miles et al. Jan 2017 A1
20170027712 Pimenta et al. Feb 2017 A1
20170143514 Gharib et al. May 2017 A1
20170143515 Gharib et al. May 2017 A1
20170156580 Miles et al. Jun 2017 A1
20170164938 Miles et al. Jun 2017 A1
20170172558 Miles et al. Jun 2017 A1
20170224507 Arnold et al. Aug 2017 A1
Foreign Referenced Citations (44)
Number Date Country
29908259 Jul 1999 DE
10048790 Apr 2002 DE
0334116 Sep 1989 EP
0567424 Oct 1993 EP
0972538 Jan 2000 EP
1002500 May 2000 EP
2795624 Jan 2001 FR
793186 May 1990 JP
10-014928 Mar 1996 JP
3019990007098 Nov 1999 KR
WO9428824 Dec 1994 WO
WO9700702 Jan 1997 WO
WO9823324 Jun 1998 WO
WO9952446 Oct 1999 WO
WO0027291 May 2000 WO
WO0038574 Jul 2000 WO
WO0044288 Aug 2000 WO
WO0062660 Oct 2000 WO
WO0066217 Nov 2000 WO
WO0067645 Nov 2000 WO
WO0108563 Feb 2001 WO
WO0137728 May 2001 WO
WO0160263 Aug 2001 WO
WO02054960 Jul 2002 WO
WO02058780 Aug 2002 WO
WO02071953 Sep 2002 WO
WO02087678 Nov 2002 WO
WO03005887 Jan 2003 WO
WO03026482 Apr 2003 WO
WO03037170 May 2003 WO
WO03084398 Oct 2003 WO
WO2004064634 Aug 2004 WO
WO2005013805 Feb 2005 WO
WO2005030318 Apr 2005 WO
WO2006042241 Apr 2006 WO
WO2006066217 Jun 2006 WO
WO2007035925 Mar 2007 WO
WO2007136784 Nov 2007 WO
WO2009055034 Apr 2009 WO
WO2011059491 May 2011 WO
WO2011059498 May 2011 WO
WO2012026981 Mar 2012 WO
WO2012103254 Aug 2012 WO
WO2013028571 Feb 2013 WO
Non-Patent Literature Citations (256)
Entry
U.S. Appl. No. 90/013,464, Warsaw Orthopedic; Inc. et al.
U.S. Appl. No. 95/001,888, Nuvasive, Inc.
U.S. Appl. No. 95/001,890, Nuvasive, Inc.
U.S. Appl. No. 90/013,546, Warsaw Orthopedic, Inc.
U.S. Appl. No. 90/013,605, Nuvasive, Inc.
U.S. Appl. No. 95/001,247, Nuvasive, Inc.
International Search report dated Apr. 27, 2001 for International Application No. PCT/US00/32329, 9 pages.
“Brackmann II EMG System,” Medical Electronics, 1999, 4 pages.
“MetRx System MicroEndoscopic Discectomy: An Evolution in Minimally Invasive Spine Surgery,” Sofamor Danek, 1999, 6 pages.
“Neurovision SE Nerve Locator/Monitor”, RLN Systems Inc. Operators Manual, 1999,22 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.
“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.
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.
Acland's Video Atlas of Human Anatomy, Section 3.1.7: Paravertebral Muscles. Available online: http://aclandanatomy.com/abstract/4010463. Accessed Jul. 11, 2012.
Amended Complaint for NuVasive, Inc. v. Globus Medical, Inc., Case No. 1:10-cv-0849 (D. Del., Oct. 5, 2010), 28 pages.
Amendment in reply to Action dated Feb. 7, 2011 and Notice dated May 12, 2011, in U.S. Appl. No. 11/789,284, dated May 17, 2011, 16 pages.
Amendment in reply dated Feb. 15, 2012 Office Action in U.S. Appl. No. 12/635,418, dated Mar. 16, 2012, 24 pages.
Anatomy of the Lumbar Spine in MED TM MicroEndoscopic Discectomy (1997 Ludann Grand Rapids MI), 14 pgs.
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.
Axon 501(k) Notification: Epoch 2000 Neurological Workstation, Dec. 3, 1997, 464 pages.
Baulot, et al., Adjuvant Anterior Spinal Fusion Via Thoracoscopy, Lyon Chirurgical, 1994, 90(5):347-351 including English Translation and Certificate of Translation.
Bergey et al., “Endoscopic Lateral Transpsoas Approach to the Lumbar Spine,” Spine, 2004, 29(15): 1681-1688.
Bose et al., Neurophysiologic Monitoring of Spinal Nerve Root Function During Instrumented Posterior Lumber Spine Surgery, Spine, 2002,27(13):1444-1450.
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. pp. 165-181.
Calancie, et al., Stimulus-evoked EMG monitoring during transpedicular lumboscaral spine instrumentation, Spine, 19(24), 1994, p. 2780-2786.
Clements et al., “Evoked and Spontaneous Electromyography to Evaluate Lumbosacral Pedicle Screw Placement,” Spine, 1996, 21(5): 600-604.
Counterclaim Defendants' Corrected Amended Invalidity Contentions re U.S. Pat. No. 8,000,782; U.S. Pat. No. 8,005,535; U.S. Pat. No. 8,016,767; U.S. Pat. No. 8,192,356; U.S. Pat. No. 8,187,334; U.S. Pat. No. 8,361,156, U.S. Pat. No. D. 652,922; U.S. Pat. No. D. 666,294 re Case No. 3:12-cv-02738-CAB(MDD), dated Aug. 19, 2013, 30 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 454.
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.
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.
Decision on Appeal in Inter Partes Reexamination Control U.S. Appl. No. 95/001,247, dated Mar. 18, 2013, 49 pages.
Declaration of Daniel Schwartz from IPR2014-0087, Oct. 21, 2013, 585 pages.
Declaration of Daniel Schwartz, from IPR2014-00073, Oct. 12, 2013, 1226 pages.
Declaration of Daniel Schwartz, from IPR2014-00074, Oct. 12, 2013, 565 pages.
Declaration of Daniel Schwartz, from IPR2014-00075, Oct. 12, 2013,1107 pages.
Declaration of Daniel Schwartz, from IPR2014-00076, Oct. 12, 2013, 1247 pages.
Declaration of Daniel Schwartz, from IPR2014-0081, Oct. 21, 2013, 585 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.
Declaration of David Hacker from IPR2014-00034, Oct. 4, 2013, 64 pages.
Declaration of David Hacker from IPR2014-00081, Oct. 10, 2013, 64 pages.
Declaration of David Hacker from IPR2014-00087, Oct. 10, 2013, 64 pages.
Declaration of David Hacker, from IPR2014-00073, Oct. 10, 2013, 64 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.
Declaration of David Hacker, from IPR2014-00076, Oct. 10, 2013, 64 pages.
Declaration of Lee Grant, from IPR2014-00034, Oct. 7, 2013, 36 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.
Declaration of Lee Grant, from IPR2014-00074, Oct. 9, 2013, 36 pages.
Declaration of Lee Grant, from IPR2014-00076, Oct. 9, 2013, 36 pages.
Declaration of Lee Grant, from IPR2014-0081, Oct. 9, 2013, 36 pages.
Declaration of Lee Grant, from IPR2014-0087, Oct. 9, 2013, 36 pages.
Declaration of Robert G. Watkins, from IPR2014-00073, Oct. 18, 2013, 1101 pages.
Declaration of Robert G. Watkins, from IPR2014-00074, Oct. 18, 2013, 548 pages.
Declaration of Robert G. Watkins, from IPR2014-00075, Oct. 18, 2013, 674 pages.
Declaration of Robert G. Watkins, from IPR2014-00076, Oct. 18, 2013, 543 pages.
Defendant's Disclosure of Asserted Claims and Preliminary Infringement Contentions Regarding U.S. Pat. No. 7,207,949; U.S. Pat. No. 7,470,236 and U.S. Pat. No. 7,582,058, Aug. 31, 2009,21 pages.
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.
Dirksmeier et al., “Microendoscopic and Open Laminotomy and Discectomy in Lumbar Disc Disease” Seminars in Soine Surgery. 1999, 11(2): 138-146.
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.
European Search Report dated Apr. 7, 2015 for EP Application No. 12826211.0.
European Search Report dated Aug. 2, 2012 for EP Application No. 12001129.1.
European Search Report dated Sep. 28, 2009 for EP Application No. 02778359.6.
Final Written Decision from IPR 2014-00034, dated Apr. 3, 2015, 48 pages.
Final Written Decision from IPR 2014-00073, dated Apr. 3, 2015, 36 pages.
Final Written Decision from IPR 2014-00074, dated Apr. 3, 2015, 31 pages.
Final Written Decision from IPR 2014-00075, dated Apr. 3, 2015, 39 pages.
Final Written Decision from IPR 2014-00081, dated Apr. 3, 2015, 44 pages.
Final Written Decision from IPR 2014-00087, dated Apr. 3, 2015, 36 pages.
Foley and Smith, “Microendoscopic Discectomy,” Techniques in Neurosurgery, 1997, 3(4):301-307.
Ford et al. “Electrical Characteristics of Peripheral Nerve Stimulators Implications for Nerve Localization,” Regional Anesthesia 1984, 9: 73-77.
Friedman, Percutaneous discectomy: An alternative to chemonucleolysis, Neurosurgery, 1983, 13(5): 542-547.
Gardocki, “Tubular diskectomy minimizes collateral damage: A logical progression moves spine surgery forward,” AAOS Now, 2009, 5 pages.
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 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.
Haig, “Point of view,” Spine, 2002, 27(24): 2819.
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.
Hovorka et al., “Five years' experience of retroperitoneal lumbar and thoracolumbar surgery,” Eur Snine J. 2000, 9(1): S30-S34.
In re: Nuvasive, Inc., in 2015-1670 decided on Dec. 7, 2016, 13 Pages.
In re: Nuvasive, Inc., in 2015-1672, 2015-1673 decided on Nov. 9, 2016, 16 Pages.
In re: Nuvasive, Inc., in 2015-1838 signed on May 10, 2017, 2 Pages.
In re: Nuvasive, Inc., in 2015-1839, 2015-1840 signed on May 10, 2017, 2 Pages.
In re: Nuvasive, Inc., in 2015-1841 decided on May 31, 2017, 16 Pages.
In re: Nuvasive, Inc., in 2015-1842, 2015-1843 signed on May 10, 2017, 2 Pages.
In re: Nuvasive, Inc., in 2017-1666, brief due Aug. 1, 2017.
In re: Nuvasive, Inc., in 2017-1668, brief due Aug. 1, 2017.
In re: Warsaw Orthopedic, Inc. in 15-1050 filed Oct. 14, 2014.
In re: Warsaw Orthopedic, Inc. in 15-1058 filed Oct. 17, 2014.
INS-1 Guide Dec. 31, 2000, Part I.
INS-1 Guide Dec. 31, 2000, Part II.
INS-1 Guide Dec. 31, 2000, Part III.
International Search Report dated Jan. 15, 2002 for International Application No. PCT/US01/18579, 6 pages.
International Search Report dated Jan. 12, 2011 for International Application No. PCT/US2010/002960.
International Search Report dated Feb. 9, 2005 for International Application PCT/US2004/031768.
International Search Report dated Mar. 27, 2003 for International Application PCT/US2002/022247.
International Search Report dated Jun. 5, 2003 for International Application No. PCT/US2002/030617.
International Search Report dated Jul. 24, 2012 for International Application No. PCT/US2012/022600.
International Search Report dated Aug. 11, 2003 for International Application No. PCT/US02/35047, 5 pages.
International Search Report dated Aug. 12, 2003 for International Application No. PCT/US03/02056, 5 pages.
International Search Report dated Oct. 18, 2001 for International Application No. PCT/US01/18606, 6 pages.
International Search Report dated Oct. 29, 2012 for International Application No. PCT/US2012/051480.
International Search Report dated Dec. 13, 2011 for International Application No. PCT/US2011/001489.
International Search Report dated Dec. 24, 2008 for International Application No. PCT/US2008/012121.
International Search Report dated Mar. 23, 2011 for International Application No. PCT/US2010/002951.
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.
Japanese Patent Office JP Patent Application No. 2006-528306 Office Action with English Translation, Jun. 10, 2009, 4 pages.
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,” Sensorv and Neuromuscular Diagnostic Instrumentation and Data Analysis I, 18th Annual International Conference on Engineering in Medicine and Biology Society, Amsterdam, 1996, pp. 144-145.
Kossmanm et al., “The use of a retractor system (SynFrame) for open, minimal invasive reconstruction of the anterior col. of the thoracic and lumbar spine,” Eur Spine J., 2001, 10: 396-402.
Kossmann, et al., Minimally Invasive Vertebral Replacement with Cages in Thoracic and Lumbar Spine, European Journal of Trauma 2001, 27: 292-300.
Larson and Maiman, “Surgery of the Lumbar Spine,” Thieme Medical Publishers, Inc., 1999, pp. 305-319.
Lenke et al., “Triggered Electromyographic Threshold for Accuracy of Pedicle Screw Placement,” spine, 1995, 20(4): 1585-1591.
Leu, et al., Percutaneous Fusion of the Lumbar Spine, Spine, 1992, 6(3): 593-604.
Litwin, et al., Hand-assisted laparoscopic surgery (HALS) with the handport system, Annals of Surgerv, 2000, 231(5):715-723.
Maguire et al., “Evaluation of Intrapedicular Screw Position Using Intraoperative Evoked Electromyography,” Spine 1995, 20(9): 1068-1074.
Marina, “New Technology for Guided Navigation with Real Time Nerve Surveillance for Minimally Invasive Spine Discectomy & Arthrodesis,” Spineline 2000, p. 39.
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.
Mathews et al., “Laparoscopic Discectomy with Anterior Lumbar Interbody Fusion,” SPINE, 1995, 20(16): 1797-1802.
Mayer “The ALIF Concept,” Eur Spine J., 2000, 9(1): S35-S43.
Mayer and Brock, Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy, J. Neurosurg, 1993, 78: 216-225.
Mayer and Wiechert, “Microsurgical Anterior Approaches to the Lumbar Spine for Interbody Fusion and Total Disc Replacement,” Neurosurgerv, 2002, 51(2): 159-165.
Mayer H. M. (ed.) Minimally Invasive Spine Surgery: A Surgical Manual. 2000. 51 pages.
Mayer, “A New Microsurgical Technique for Minimally Invasive Anterior Lumbar Interbody Fusion,” Spine, 1997, 22(6): 691-699.
McAfee et al., Minimally Invasive Anterior Retroperitoneal Approach to the Lumbar Spine: Emphasis on the Lateral BAK, Spine, 1998, 23(13): 1476-1484.
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.
Medtronic Sofamor Danek “METRx System Surgical Technique,” 2004, 22 pages.
Medtronic Sofamor Danek “METRx TM MicroDiscectomy System,” Medtronic Sofamor Danek USA, 2000, 21 pgs.
Medtronic Sofamor Danek “UNION TM / UNION-LTM Anterior & Lateral Impacted Fusion Devices: Clear choice of stabilization,” Medtronic Sofamor Danek, 2000, 4 pages.
Medtronic Sofamor Danek “UNION TM / UNION-LTM Anterior & Lateral Impacted Fusion Devices: Surgical Technique” Medtronic Sofamor Danek, 2001, 20 pages.
Medtronic XOMED Surgical Products, Inc., NIM-Response Nerve Integrity Monitor Intraoperative EMG Monitor User's Guide, Revision B, 2000, 47 pages.
Merriam-Webster's Collegiate Dictionary, p. 65 (l0th ed. 1998).
METRx Delivered Order Form, 1999, 13 pages.
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.
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(II):9.
Notice of Allowance dated Mar. 30, 2017 for U.S. Appl. No. 14/263,797.
Notice of Allowance dated Apr. 12, 2017 for U.S. Appl. No. 15/272,071.
Notice of Allowance in U.S. Appl. No. 11/789,284, dated Jul. 18, 2011, 8 pages.
NuVasive “INS-1 Screw Test,” 2001, 10 pages.
NuVasive 510(k) Premarket Notification: Neurovision JJB System (Device Description), Aug. 20, 2007, 8 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).
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 letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5 pages.
NuVasive letter re: 510(k) for Neurovision JJB System (Summary), Sep. 25, 2001, 28 pages.
NuVasive letter re: 510(k) Premarket Notification: Guided Spinal Arthroscopy System (Device Description), Feb. 1, 1999, 40 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), 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: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Sep. 14, 2006, 17 pages.
NuVasive Triad TM Cortical Bone Allograft, 2000, 1 page (prior to Sep. 25, 2003).
NuVasive Triad TM Tri-Columnar Spinal EndoArthrodesis TM via Minimally Invasive Guidance, 2000, 1 page (prior to Sep. 25, 2003).
NuVasive Vector TM Cannulae, 2000, 1 page.
NuVasive Vertebral Body Access System, 2000, 1 page.
Nuvasive, Inc. v. Medtronic, Inc. in 15-1674 filed May 26, 2015, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Nuvasive, Inc. v. Medtronic, Inc. in 15-1712 filed Jun. 8, 2015, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Nuvasive, Inc. v. Warsaw Orthopedic, Inc. in 15-1049 filed Oct. 14, 2014, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Nuvasive, Inc's Opening Claim Construction Brief Regarding U.S. Pat. No. 8,000,782; 472 U.S. Pat. No. 8,005,535; U.S. Pat. No. 8,016,767; U.S. Pat. No. 8,192,356; U.S. Pat. No. 8,187,334; U.S. Pat. No. 8,361,156; U.S. Pat. No. D. 652,922; and U.S. Pat. No. 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.
NuVasive's spine surgery system cleared in the US, Pharm & Medical Industry Week, Dec. 10, 2001, 1 page.
NuVasiveTM Receives Clearance to Market Two Key Elem Minimally Invasive Spine Surgery System, Nov. 27, 2001, 20 pages.
Office Action dated Jan. 11, 2012 for U.S. Appl. No. 11/982,185.
Office Action dated Jan. 12, 2012 for U.S. Appl. No. 11/489,020.
Office Action dated Jan. 21, 2011 for U.S. Appl. No. 11/982,185.
Office Action dated Feb. 26, 2016 for U.S. Appl. No. 14/622,585.
Office Action dated Mar. 16, 2009 for U.S. Appl. No. 11/489,020.
Office Action dated Mar. 29, 2017 for U.S. Appl. No. 15/448,395.
Office Action dated Apr. 5, 2017 for U.S. Appl. No. 15/445,854.
Office Action dated Apr. 6, 2017 for U.S. Appl. No. 15/439,889.
Office Action dated Apr. 7, 2017 for U.S. Appl. No. 15/059,215.
Office Action dated Apr. 29, 2010 for U.S. Appl. No. 11/982,185.
Office Action dated May 6, 2010 for U.S. Appl. No. 11/489,020.
Office Action dated May 8, 2014 for U.S. Appl. No. 13/964,836.
Office Action dated Jun. 17, 2009 for U.S. Appl. No. 11/982,185.
Office Action dated Sep. 15, 2008 for U.S. Appl. No. 11/489,020.
Office Action dated Sep. 19, 2016 for U.S. Appl. No. 14/263,797.
Office Action dated Sep. 23, 2016 for U.S. Appl. No. 14/622,585.
Office Action dated Oct. 9, 2009 for U.S. Appl. No. 11/489,020.
Office Action dated Oct. 20, 2016 for U.S. Appl. No. 14/297,369.
Office Action dated Nov. 28, 2016 for U.S. Appl. No. 14/994,640.
Office Action dated Nov. 4, 2016 for U.S. Appl. No. 14/297,438.
Office Action dated Dec. 19, 2014 for U.S. Appl. No. 13/964,836.
Office action from U.S. Appl. No. 11/789,284, dated Feb. 7, 2011, 10 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00034, dated Jan. 15, 2014, 66 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00035, dated Jan. 15, 2014, 42 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00073, dated Jan. 31, 2014, 2014, 46 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00074, dated Jan. 31, 2014, 68 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00075, dated Jan. 31, 2014, 54 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00076, dated Jan. 31, 2014, 58 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00081, dated Jan. 31, 2014, 47 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00087, dated Jan. 31, 2014, 51 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00034, dated Apr. 8, 2014, 35 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00035, dated Apr. 8, 2014, 12 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00073, dated Apr. 8, 2014, 34 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00074, dated Apr. 8, 2014, 28 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00075, dated Apr. 8, 2014, 23 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00076, dated Apr. 8, 2014, 11 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00081, dated Apr. 8, 2014, 31 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00087, dated Apr. 8, 2014, 31 pages.Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2013-00504 filed Aug. 14, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2013-00506 filed Aug. 14, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2013-00507 filed Aug. 14, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2013-00508 filed Aug. 14, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2014-00034 filed Oct. 8, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2014-00035 filed Oct. 8, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2014-00071 filed Oct. 16, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by Medtronic, Inc. in IPR2014-00487 filed Mar. 5, 2014, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by NuVasive, Inc. in IPR2013-00206 filed Mar. 22, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by NuVasive, Inc. in IPR2013-00208 filed Mar. 22, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by NuVasive, Inc. in IPR2013-00395 filed Jun. 27, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by NuVasive, Inc. in IPR2013-00396 filed Jun. 27, 2013, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
Petition for Inter Partes Review by NuVasive, Inc. in IPR2015-00502 filed Dec. 24, 2014, Individual documents of the referenced court case are not being submitted herewith, as Applicant understands the documents to be readily accessible by the Examiner. However, Applicant can provide any of the documents upon request.
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.
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.
Pimenta, et al., Implante de protese de nucleo pulposo: analise inicial, Journal Brasileiro de Neurocirurgia, 2001, 12(2): 93-96.
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 /MAST, May 2002, 1 page.
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.
Plaintiffs' Preliminary Invalidity Contentions re U.S. Pat. No. 7,207,949; U.S. Pat. No. 7,470,236 and U.S. Pat. No. 7,582,058, Sep. 18, 2009, 19 pages.
Plaintiffs' Preliminary Invalidity Contentions-Appendices, Sep. 18, 2009, 191 pages.
Plaintiffs' Supplemental Preliminary Invalidity Contentions re U.S. Pat. No. 7,207,949, U.S. Pat. No. 7,470,236, and U.S. Pat. No. 7,582,058, Sep. 29, 2009, 21 pages.
Plaintiffs' Supplemental Preliminary Invalidity Contentions-Appendices, Sep. 29, 2009, 294 pages.
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.
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.
Raymond et al., “The nerve seeker: A system for automated nerve localization” Regional Anesthesia (1992) 17(3):151-162.
Request for Inter Partes Reexamination In re U.S. Pat. No. 7,905,840, dated Feb. 8, 2012, 204 pages.
Request for Inter Partes Reexamination In re: U.S. Pat. No. 7,691,057, dated Feb. 8, 2012, 50 pages.
Request for Inter PartesReexamination In re U.S. Pat. No. 7,819,801, dated Feb. 8, 2012, 89 pages.
Rose et al., “Persistently Electrified Pedicle Stimulation Instruments in Spinal Instrumentation: Techniques and Protocol Development,” SPINE, 1997, 22(3): 334-343.
Rosenthal, et al., Removal of a Protruded Thoracic Disc Using Microsurgical Endoscopy, Spine, 1994, 19(9): 1087-1091.
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.
Schick et al., “Microendoscopic lumbar discectomy versus open surgery: an intraoperative EMG study,” Eur Spine J, 2002, 11: 20-26.
Shafik, “Cavernous Nerve Simulation through an Extrapelvic Subpubic Approach: Role in Penile Erection,” Eur. Ural, 1994,26: 98-102.
Smith and Foley “MetRx System MicroEndoscopic Discectomy: Surgical Technique” Medtronic Sofamor Danek, 2000, 24 pages.
Toleikis et al., “The Usefulness of Electrical Stimulation for Assessing Pedicle Screw Replacements,” Journal of Spinal Disorder 2000, 13(4): 283-289.
Traynelis, Spinal Arthroplasty, Neurological Focus, 2002, 13(2): 12 pages.
U.S. Appl. No. 60/325,424, filed Sep. 25, 2001, 346 pages.
U.S. Appl. No. 60/392,214, filed Jun. 26, 2002, 97 pages.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 12-1263 filed Mar. 15, 2012.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 12-1266 filed Mar. 15, 2012.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 13-1576 filed Aug. 21, 2013.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 13-1577 filed Aug. 21, 2013.
Wolfa et al., “Retroperitoneal lateral lumbar interbody fusion with titanium threaded fusion cages,” J. Neurosurg (Spine 1), 2002, 96: 50-55.
Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999. 43 pages.
Tannoury, “Minimally Invasive Spine Surgery: How, When and Why for Athletes?”, Aspetar Sports Medicine Journal, 2016, 5(2).
Related Publications (1)
Number Date Country
20190298326 A1 Oct 2019 US
Provisional Applications (1)
Number Date Country
60440905 Jan 2003 US
Divisions (1)
Number Date Country
Parent 13756883 Feb 2013 US
Child 13856648 US
Continuations (10)
Number Date Country
Parent 15792652 Oct 2017 US
Child 16443732 US
Parent 15058083 Mar 2016 US
Child 15792652 US
Parent 14287982 May 2014 US
Child 15058083 US
Parent 14018209 Sep 2013 US
Child 14287982 US
Parent 13856648 Apr 2013 US
Child 14018209 US
Parent 13466531 May 2012 US
Child 13756883 US
Parent 13417499 Mar 2012 US
Child 13466531 US
Parent 12650301 Dec 2009 US
Child 13417499 US
Parent 12636860 Dec 2009 US
Child 12650301 US
Parent 10759811 Jan 2004 US
Child 12636860 US