Surgical access system and related methods

Abstract
A system for accessing a surgical target site and related methods, involving an initial distraction system for creating an initial distraction corridor, and an assembly capable of distracting from the initial distraction corridor to a secondary distraction corridor and thereafter sequentially receiving a plurality of retractor blades for retracting from the secondary distraction corridor to thereby create an operative corridor to the surgical target site, 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

I. Field


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. Description of Related 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

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 the cross-sectional area of the distraction corridor (and/or modifying its shape) with at least one retractor blade and thereafter maintaining that increased cross-sectional area and/or modified shape such that surgical instruments can be passed through operative corridor to the surgical target site. 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, including those wherein tissue having significant neural structures must be passed through (or near) in order to establish an operative corridor.


According to one aspect, the present invention provides a surgical access system having an initial tissue distraction assembly and a pivot linkage assembly forming part of a secondary distraction assembly and a retraction assembly. The secondary distraction assembly includes first and second distraction arms forming part of the pivot linkage assembly, first and second speculum blades extending through receiving passageways formed within the first and second distraction arms, and a handle assembly forming part of the pivot linkage. As will be described below, the distraction arms may be advanced over the initial distraction assembly such that the speculum blades are passed into the tissue to be secondarily distracted. Thereafter, the handle assembly may be activated to perform the necessary distraction. That is, the handle assembly can be manipulated by a user to move the first and second distraction arms away from one another, which will at the same time move the distal ends of the speculum blades to create a full distraction corridor.


After the secondary distraction, a pair of retractors blades may be introduced into the distraction corridor and positioned to create an operative corridor to the surgical target site. In a preferred embodiment, retractor blade is introduced first and positioned such that its distal end is generally located towards the posterior region of the spinal target site, which forms a useful barrier to prevent any exiting nerve roots 30 from entering the surgical target site, as well as to prevent any surgical instruments from passing outside the surgical target site and into contact with the exiting nerve roots 30 or other sensitive tissue. The retractor blade may thereafter be introduced and moved in a generally anterior direction away from the retractor blade, effectively creating the operative corridor. The retractor blades may be locked in relation to the pivot linkage assembly in any number of suitable fashions, including but not limited to the use of the nut-bolt assemblies well known in the art. To lock the retractor blades in relation to the surgical target site, optional locking members may be advanced through receiving passageways formed in one or more of the retractor blades such that a distal region of the locking member is brought into a press-fit, secure engagement between the adjacent vertebral bodies to thereby maintain the respective retractor blade in position. With the operative corridor established, any of a variety of surgical instruments, devices, or implants may be passed through and/or manipulated at or near the surgical target site depending upon the given surgical procedure.


According to yet another aspect of the present invention, any number of distraction assemblies and/or retraction assemblies (including but not limited to those described herein) may be equipped to detect the presence 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.





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 surgical access system according to one aspect of the present invention;



FIG. 2 is a perspective view of an initial tissue distraction assembly forming part of a surgical access system according to the present invention;



FIGS. 3-4 are exploded views detailing the distal portions of the initial tissue distraction assembly shown in FIG. 2;



FIG. 5 is a perspective view of a pivot linkage assembly equipped with speculum blades according to the present invention;



FIG. 6 is a side view of the pivot linkage assembly shown in FIG. 5;



FIGS. 7-8 are perspective views showing the pivot linkage assembly of FIG. 5 in use;



FIGS. 9-10 are perspective views of a retractor blade forming part of a surgical access system according to the present invention;



FIG. 11 is a perspective view of a locking member for use with the retractor blade of FIGS. 9-10 according to the present invention;



FIG. 12 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. 13 is a block diagram of the nerve monitoring system shown in FIG. 12;



FIGS. 14-15 are screen displays illustrating exemplary features and information communicated to a user during the use of the nerve monitoring system of FIG. 12;



FIGS. 16-33 illustrate the various method steps (some optional) involved in accessing (by way of example only) a surgical target site in the spine according to the present invention.





DETAILED DESCRIPTION

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.


The present invention is directed at 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 steps of distraction followed by retraction are advantageous because they provide 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.



FIG. 1 illustrates a surgical access system 10 according to one aspect of the present invention. The surgical access system 10 includes an initial tissue distraction assembly 12 and a pivot linkage assembly 14 forming part of a secondary distraction assembly and a retraction assembly. The secondary distraction assembly includes first and second distraction arms 16, 18 forming part of the pivot linkage assembly 14, first and second speculum blades 20, 22 extending through receiving passageways formed within the first and second distraction arms 16, 18, and a handle assembly 24 forming part of the pivot linkage 14. As will be described below, the distraction arms 16, 18 may be advanced over the initial distraction assembly 12 such that the speculum blades 20, 22 are passed into the tissue to be secondarily distracted. Thereafter, the handle assembly 24 may be activated to perform the necessary distraction. That is, the handle assembly 24 can be manipulated by a user to move the first and second distraction arms 16, 18 away from one another, which will at the same time move the distal ends of the speculum blades 20, 22 to create a full distraction corridor.


After the secondary distraction, a pair of retractors blades 26, 28 may be introduced into the distraction corridor and positioned to create an operative corridor to the surgical target site. In a preferred embodiment, retractor blade 26 is introduced first and positioned such that its distal end is generally located towards the posterior region of the spinal target site, which forms a useful barrier to prevent any exiting nerve roots 30 from entering the surgical target site, as well as to prevent any surgical instruments from passing outside the surgical target site and into contact with the exiting nerve roots 30 or other sensitive tissue. The retractor blade 28 may thereafter be introduced and moved in a generally anterior direction away from the retractor blade 26, effectively creating the operative corridor. The retractor blades 26, 28 may be locked in relation to the pivot linkage assembly 14 in any number of suitable fashions, including but not limited to the use of the nut-bolt assemblies 32, 34 well known in the art. To lock the retractor blades 26, 28 in relation to the surgical target site, optional locking members 36 may be advanced through receiving passageways formed in one or more of the retractor blades 26, 28 such that a distal region of the locking member 36 is brought into a press-fit, secure engagement between the adjacent vertebral bodies to thereby maintain the respective retractor blade 26, 28 in position. With the operative corridor established, any of a variety of surgical instruments, devices, or implants may be passed through and/or manipulated at or near the surgical target site depending upon the given surgical procedure.


Distraction


FIG. 2 illustrates the initial tissue distraction assembly 12, which is designed to perform an initial distraction of tissue from the skin of the patient down to or near the surgical target site. The initial tissue distraction assembly 12 may be constructed from any number of materials suitable for medical applications, including but not limited to plastics, metals, ceramics or any combination thereof. Depending on the construction, some or all of the tissue distraction assembly 12 may be disposable (i.e. single use) and/or reusable (i.e. multi-use).


The initial tissue distraction assembly 12 may include any number of components capable of performing the necessary initial distraction. By way of example, with combined reference to FIGS. 2-4, this may be accomplished by providing the initial distraction assembly 12 as including a K-wire 44 and one or more dilators 46, 48. The K-wire 44 is preferably constructed having generally narrow diameter (such as, by way of example only, 1.5 mm) and sufficient rigidity and strength such that it can pierce the skin of the patient and be advanced through the intervening tissue to reach the surgical target site. The K-wire 44 also preferably includes indicia for determining the distance between a distal end 50 and the skin of the patient. The dilators 46, 48 are inner and outer dilating elements, respectively, capable of being sequentially introduced over the K-wire 44 for the purpose of further distracting the tissue previously distracted by the K-wire 44.


The inner dilator 46 is preferably constructed having an inner diameter approximating the diameter of the K-wire 44 (such as, by way of example only, 1.5 mm), an outer diameter of increased dimension (such as, by way of example only, 6.5 mm), and indicia for determining the distance between a distal end 52 and the skin of the patient. The outer dilator 48 is similarly preferably constructed having an inner diameter approximating the outer diameter of the inner dilator 46 (such as, by way of example only, 6.5 mm), an outer diameter of increased dimension (such as, by way of example only, 9 mm), and indicia for determining the distance between a distal end 54 and the skin of the patient. The respective lengths of the K-wire 44 and dilators 46, 48 may vary depending upon the given surgical target site (that is, the “depth” of the surgical target site within the patient). It will be similarly appreciated that the diameters and dimensions for these elements may also vary depending upon the particular surgical procedure. All such surgically appropriate variations (length, diameter, etc. . . . ) are contemplated as falling within the scope of the present invention. It is further contemplated and within the scope of the present invention that additional dilators of increasing diameters may be employed to sequentially dilate to the point where a bladed retractor or retraction assembly may be employed to thereafter create an operative corridor according to the present invention (without the need for secondary distraction as described below).


Referring to FIGS. 5-6, the secondary tissue distraction is preferably performed using the pivot linkage assembly 14 in conjunction with the first and second distraction arms 16, 18 and first and second speculum blades 20, 22. The speculum blades 20, 22 extend through receiving passageways 38 (FIG. 6) formed within the first and second distraction arms 16, 18. The handle assembly 24 includes first and second pivot arms 60, 62 disposed on one end of the assembly, and third and fourth pivot arms 64, 66 on the opposite end. First and second pivot arms 60, 62 are pivotably coupled via a rod 80 forming part of the locking assembly 32 (a locking nut 82 forms the remainder of the locking assembly 32). Second and third pivot arms 64, 66 are pivotably coupled via a rod 84 forming part of the locking assembly 34 (a locking nut 86 forms the remainder of the locking assembly 34).


First and second linkage assemblies 70, 72 extend between the distal ends of the pivot arms 60-66, each including a pair of linkages 74, 76 pivotably coupled together via a rod 78. A ratchet member 68 may be used to maintain the first pivot arms 60 relative to the second pivot arm 62 as they are separated during use. As the pivot arms 60, 62 are moved away from one another, the first and second distraction arms 16, 18 (being coupled to or integrally formed with the linkages 76 of first and second linkage assemblies 72, 74) will similarly move away from one another. With the speculum blades 20, 22 disposed within the passageways 38 (FIG. 5), the relative movement of the pivot arms 16, 18 will cause the speculum blades 20, 22 to move apart and thus perform the desired secondary distraction.


The pivot linkage assembly 14 may be constructed from any number of materials suitable for medical applications, including but not limited to plastics, metals, ceramics or any combination thereof. Depending on the construction, some or all of the pivot linkage assembly 14 may be disposable (i.e. single use) and/or reusable (i.e. multi-use).


The speculum blades 20, 22 are generally elongate in nature and include a pair of mating grooves 88 formed along the inwardly facing surfaces of the speculum blades 20, 22 which, when mated together, form a lumen capable of passing over the K-wire 44. In a preferred embodiment, the speculum blades 20, 22 are separable from distraction arms 16, 18 such that the blades 20, 22 can be introduced into the patient and thereafter engaged with the handle assembly 24 to effectuate the secondary distraction. As will be described in greater detail below, this separable construction allows the speculum blades 20, 22 to be introduced down to the surgical target site by passing them through the outer dilator 48 and over with the K-wire 44 (the latter by virtue of the lumen formed by the pair of mating grooves 88 along the inwardly facing surfaces of the speculum blades 20, 22). This is obviously only possible by first removing the inner dilator 46 from within the second dilator 48 while leaving the K-wire 44 in place. Although shown and described herein as being of separable construction, it will be appreciated by those skilled in the art that the speculum blades 20, 22 may be of generally non-separable or fixed construction with the pivot arms 16, 18 of the handle assembly 24.


Retraction

The retraction of the present invention is performed by expanding and/or modifying the distraction corridor to establish and maintain an operative corridor to the surgical target site. As shown in FIGS. 7-10, the pivot linkage 14 is configured to receive (and have coupled thereto) a pair of retractor blades 90, 92 of the type shown in FIGS. 9-10. The retractor blades 90, 92 include a main body element 94 extending downwardly and angularly away from a pair of mounting arms 96, 98. The mounting arms 96, 98 are spaced apart from one another so as to create a channel 100 dimensioned to receive the respective rods 80, 84 of the locking assemblies 32, 34. Once positioned within the channel 100, the retractor blades 90, 92 may be locked in a desired position by tightening the respective nuts 82, 86 of the locking assemblies 32, 34.


In a preferred embodiment, one or more of the retractor blades 90, 92 may be equipped with a passageway 102 at or near the distal end of the main body 94, such as by providing a generally planar member 104 along the generally curved distal region of the retractor blade 90, 92. This passageway 102 is dimensioned to receive a locking member 36 of the type shown in FIG. 11. The locking member 36 includes a coupling region 106 for engagement with an introducer tool 112 (FIG. 8), a main body region 108 to be disposed generally within the passageway 102 in use, and a distal region 110 to be introduced into the disc space and engaged between the adjacent vertebral bodies to secure the distal ends of the retractor blades 90, 92 during use. In addition to securing the retractor blades 90, 92 relative to the surgical target site, the distal region 110 also serves to prevent the ingress of unwanted or sensitive biological structures (e.g., nerve roots and/or vasculature) into the surgical target site, as well as prevent instruments from passing outside the surgical target site and contacting surrounding tissues or structures.


The retractor blades 90, 92 may also be optionally provided with at least one guard member 114 extending in a curved fashion (and/or, although not shown, in a generally straight fashion) from the distal end of the retractor blade 90, 92. The guard member 114 may be provided, by way of example, for the purpose of preventing tissue (such as nerve roots in spinal surgery applications) from entering into the operative corridor during surgery and for preventing instruments from extending outside the operative corridor and/or the general vicinity of the surgical target site.


The retractor blades 90, 92 may also be equipped with any number of different mechanisms 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. For example, one or more strands of fiber optic cable may be coupled to the retractor blades 90, 92 such that light may be delivered from a light source and selectively emitted into the operative corridor and/or the surgical target site. This may be accomplished by constructing the retractor blades 90, 92 of suitable material (such as clear polycarbonate) and configuration such that light may be transmitted generally distally through a light exit region formed along the entire inner periphery of the retractor blade 90, 92 and located in the general vicinity as the distal opening of the passageway 102. This may be performed by providing the retractor blade 90, 92 having light-transmission characteristics (such as with clear polycarbonate construction) and transmitting the light almost entirely within the walls of the retractor blade 90, 92 (such as by frosting or otherwise rendering opaque portions of the exterior and/or interior and coupling the light source thereto such as via a port) until it exits a portion along the interior of the retractor blades 90, 92 to shine at or near the surgical target site.


In one embodiment, a variety of sets of retractor blades 90, 92 may be provided, each having a different length to account for any number of possible surgical target sites. In a further embodiment, each set of retractor blades 90, 92 may be marked or color-coded to aid in indicating to the surgeon the particular length of the blade 90, 92 or the depth of the surgical target site.


The retractor blades 90, 92 and the locking member 36 may be constructed from any number of materials suitable for medical applications, including but not limited to plastics, metals, ceramics or any combination thereof. Depending on the construction, some or all of these devices may be disposable (i.e. single use) and/or reusable (i.e. multi-use).


Any number of suitable mounting units (not shown) may be employed to maintain the pivot linkage assembly 14 in a fixed and rigid fashion relative to the patient. By way of example only, this may be accomplished by providing the mounting unit as a generally U-shaped mounting arm for lockable engagement with the pivot linkage assembly 14, and a coupling mechanism (not shown) extending between the mounting arm and a rigid structure (such as the operating table) for maintaining the U-shaped mounting arm in a fixed and rigid position.


Nerve Surveillance

According to yet another aspect of the present invention, any number of distraction components and/or retraction components (including but not limited to those described herein) may be equipped to detect the presence of (and optionally the distance and/or direction to) neural structures during the steps tissue 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 PCT Applications (collectively “NeuroVision PCT 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; and PCT App. Ser. No. PCT/US03/02056, entitled “System and Methods for Determining Nerve Direction to a Surgical Instrument,” filed Jan. 15, 2003. The entire contents of each of the above-enumerated NeuroVision PCT Applications is hereby expressly incorporated by reference into this disclosure as if set forth fully herein.


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.



FIGS. 12-13 illustrate, by way of example only, a monitoring system 120 of the type disclosed in the NeuroVision PCT Applications suitable for use with the surgical access system 10 of the present invention. The monitoring system 120 includes a control unit 122, a patient module 124, and an EMG harness 126 and return electrode 128 coupled to the patient module 124, and a cable 132 for establishing electrical communication between the patient module 124 and the surgical access system 10 (FIG. 1). More specifically, this electrical communication can be achieved by providing, by way of example only, a hand-held stimulation controller 152 capable of selectively providing a stimulation signal (due to the operation of manually operated buttons on the hand-held stimulation controller 152) to one or more connectors 156a, 156b, 156c. The connectors 156a, 156b, 156c are suitable to establish electrical communication between the hand-held stimulation controller 152 and (by way of example only) the stimulation electrodes on the K-wire 44, the dilators 46, 46, the speculum blades 20, 22, the retractor blades 90, 92, and/or the guard members 114 (collectively “surgical access instruments”).


In order to use the monitoring system 120, then, these surgical access instruments must be connected to the connectors 156a, 156b and/or 156c, at which point the user may selectively initiate a stimulation signal (preferably, a current signal) from the control unit 122 to a particular surgical access instruments. Stimulating the electrode(s) on these surgical access instruments before, during and/or after establishing operative corridor will cause nerves that come into close or relative proximity to the surgical access instruments to depolarize, producing a response in a myotome associated with the innervated nerve.


The control unit 122 includes a touch screen display 140 and a base 142, which collectively contain the essential processing capabilities (software and/or hardware) for controlling the monitoring system 120. The control unit 122 may include an audio unit 118 that emits sounds according to a location of a surgical element with respect to a nerve. 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 electrodes on the surgical access instruments, processing signal data according to defined algorithms, displaying received parameters and processed data, and monitoring system status and report 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 (hardware and/or software) 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.


In one embodiment, the monitoring system 120 is capable of determining nerve direction relative to one or more of the K-wire 44, dilation cannula 46, 48, speculum blades 20, 22, the retractor blades 90, 92, and/or the guard members 114 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 instruments. Depending upon the location of the surgical access system 10 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 system 10 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 10 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 surgical access system 10 after the operative corridor has been established. In spinal surgery, for example, this is particularly advantageous in that the surgical access system 10 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. 14-15 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. 12-13. 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 (in this case, a dilator 46, 48), 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 dilator 46, 48) 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. 15) 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 instruments forming the surgical access system 10 of the present invention, including the initial distraction assembly 12 (i.e. the K-wire 44 and dilators 46, 48), the speculum blades 20, 22 and/or the retractor blades 90, 92 and/or the guard members 114.


The initial distraction assembly 12 (FIGS. 2-4) may be provided with one or more electrodes for use in providing the neural monitoring capabilities of the present invention. By way of example only, the K-wire 44 may be equipped with a distal electrode 200. This may be accomplished by constructing the K-wire 44 for a conductive material, providing outer layer of insulation 202 extending along the entire length with the exception of an exposure that defines the electrode 200. As best shown in FIGS. 3-4, the electrode 200 has an angled configuration relative to the rest of the K-wire 44 (such as, by way of example only, in the range of between 15 and 75 degrees from the longitudinal axis of the K-wire 44). The angled nature of the electrode 200 is advantageous in that it aids in piercing tissue as the K-wire 44 is advanced towards the surgical target site.


The angled nature of the distal electrode 200 is also important in that it provides the ability to determine the location of nerves or neural structures relative to the K-wire 44 as it is advanced towards or resting at or near the surgical target site. This “directional” capability is achieved by the fact that the angled nature of the electrode 200 causes the electrical stimulation to be projected away from the distal portion of the K-wire 44 in a focused, or directed fashion. The end result is that nerves or neural structures which are generally closer to the side of the K-wire 44 on which the electrode 200 is disposed will have a higher likelihood of firing or being innervated that nerves or neural structures on the opposite side as the electrode 200.


The direction to such nerves or neural structures may thus be determined by physically rotating the K-wire 44 at a particular point within the patient's tissue and monitoring to see if any neural stimulation occurs at a given point within the rotation. Such monitoring can be performed via visual observation, a traditional EMG monitoring, as well as the nerve surveillance system disclosed in the above-referenced NeuroVision PCT Applications. If the signals appear more profound or significant at a given point within the rotation, the surgeon will be able tell where the corresponding nerves or neural structures are, by way of example only, by looking at reference information (such as the indicia) on the exposed part of the K-wire 44 (which reference point is preferably set forth in the exact same orientation as the electrode 200).


Dilators 46, 48 may also be provided with angled electrodes 204, 206, respectively, for the purpose of determining the location of nerves or neural structures relative to the dilators 46, 48 as they are advanced over the K-wire 44 towards or positioned at or near the surgical target site. Due to this similarity in function with the electrode 200 of the K-wire 44, a repeat explanation is not deemed necessary. The dilators 46, 48 may be equipped with the electrodes 204, 206 via any number of suitable methods, including but not limited to providing electrically conductive elements within the walls of the dilators 46, 48, such as by manufacturing the dilators 46, 48 from plastic or similar material capable of injection molding or manufacturing the dilators 46, 48 from aluminum (or similar metallic substance) and providing outer insulation layer with exposed regions (such as by anodizing the exterior of the aluminum dilator).


According to one aspect of the present invention, additional neural monitoring equipment may be employed so as to further prevent inadvertent contact with neural structures. For example, after the initial dilator 46 has been withdrawn in order to subsequently receive the mated speculum blades 20, 22, a confirmation probe (providing a stimulation signal) may be inserted through the outer dilator 48 and to a point at or near the surgical target site. The confirmation probe may thereafter be stimulated for the purpose of double-checking to ensure that no nerves or neural structures are disposed in the tissue near (or have migrated into the vicinity of) the distal end 54 of the outer dilator 48 before introducing the speculum blades 20, 22. By confirming in this fashion, the outer dilator 48 may be removed following the introduction of the speculum blades 20, 22 and the secondary distraction performed (by coupling the handle assembly 24 to the blades 20, 22 and expanding) without fear of inadvertently causing the speculum blades 20, 22 to contact nerves or neural structures.


The secondary distraction of the present invention (FIGS. 5-6) may 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 along the speculum blades 20, 22 and/or on the concave region 252 (such as stimulation electrode 208) for the purpose of conducting neural monitoring before, during and/or after the secondary distraction.


The retractor blades 90, 92 of the present invention (FIGS. 7-10) 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 210 on the guard members 114 and/or the stimulation electrodes 212 on the locking members 36 (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 90, 92 have been positioned at or near the surgical target site.


The surgical access system 10 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 pivot linkage assembly 14 may be provided such that the pivot arms 16, 18 and speculum blades 20, 22 are disposable and the retractor blades 90, 92 are reusable. In a further embodiment, an initial kit may include these materials, including a variety of sets of retractor blades 90, 92 having varying (or “incremental”) lengths to account for surgical target sites of varying locations within the patient.


Spine Surgery Example

The surgical access system 10 of the present invention will now be described, by way of example, with reference to the spinal application shown in FIGS. 16-33. It will, of course, be appreciated that 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. More specifically, 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.



FIGS. 16-22 illustrate the method steps involved in using the initial tissue distraction assembly 12 of the present invention. The K-wire 44 is first introduced along a given pathway towards the surgical target site (which, in this case, is an intervertebral disc level of the lumbar spine). Determining the preferred angle of incidence into the surgical target site (as well as the advancement or positioning of any required surgical instruments (such as the surgical access system of the present invention), devices and/or implants) may be facilitated through the use of surgical imaging systems (such as fluoroscopy) as well any number of stereotactic guide systems, including but not limited to those shown and described in co-pending and commonly owned U.S. patent application Ser. No. 09/888,223, filed Jun. 22, 2001 and entitled “Polar Coordinate Surgical Guideframe,” the entire contents of which is incorporated by reference as if set forth in its entirety herein.


Nerve surveillance is preferably conducted during this step (via electrode 200) to monitor for the existence of (and optionally the distance and direction to) nerves or neural structures in the tissue through which the K-wire 44 must pass to reach the surgical target site. According to a preferred embodiment of the present invention, it is generally desired to advance the K-wire 44 such the distal electrode 200 is disposed a distance anterior to the exiting nerve root 300 (such as, by way of example, 10 mm). As shown in FIGS. 16-17, it is preferred to advance the K-wire 44 to the annulus 302 of the disc before advancing the inner dilator 46. This is to prevent the unnecessary distraction of the psoas muscle 304 (which must be passed through in order to approach the surgical target site in the lateral or far-lateral approach shown) in the instance significant nerves or neural structures are encountered in the initial advancement of the K-wire 44. If such nerves or neural structures are encountered, the K-wire 44 may simply be removed and re-advanced along a different approach path.


As shown in FIGS. 18-19, once the K-wire 44 is safely introduced to the surgical target site, the inner dilator 46 may thereafter be advanced over the K-wire 44 until the distal end 52 abuts the annulus 302 of the disc. Nerve surveillance is also conducted during this step (via electrode 204 shown in FIGS. 3-4) to monitor for the existence of (and optionally the distance and direction to) nerves or neural structures in the tissue through which the inner dilator 46 must pass to reach the surgical target site. Next, as shown in FIG. 22, the K-wire 44 may be advanced through the annulus 302 such that the electrode 200 is disposed within the interior (nucleus pulposis region) of the disc (such as, by way of example, an internal distance of 15 to 20 mm).


With reference to FIGS. 21-22, the outer dilator 48 is next advanced over the inner dilator 46 to further distract the tissue leading down to the surgical target site. As with the K-wire 44 and inner dilator 46, nerve surveillance is conducted during this step (via electrode 206 shown in FIGS. 3-4) to monitor for the existence of (and optionally the distance and direction to) nerves or neural structures in the tissue through which the outer dilator 48 must pass to reach the surgical target site.


With reference to FIG. 23, the inner dilator 48 is next removed, leaving the K-wire 44 and outer dilator 48 in position. This creates a space therebetween which, in one embodiment of the present invention, is dimensioned to receive the speculum blades 20, 22 as shown in FIGS. 24-25. To accomplish this step, the speculum blades 20, 22 must be disposed in an abutting relationship so as to form an inner lumen (via corresponding grooves 88 shown in FIG. 5) dimensioned to be slideably advancing over the stationary K-wire 44. Once again, as noted above, it may be desired at this step to advance a confirmation probe down the outer dilator 48 to interrogate the tissue surrounding the surgical target site to ensure that no nerves or neural structures are present in (or have migrated into) this vicinity before the speculum blades 20, 22 are advanced into the outer dilator 48.


Turning to FIGS. 26-27, the outer dilator 48 may then be removed, leaving the speculum blades 20, 22 in abutting relationship within the tissue previously distracted by the outer dilator 48. As shown in FIGS. 28-29, the pivot linkage assembly 14 may be advanced such that the pivot arms 16, 18 slideably (or otherwise) pass over the speculum blades 20, 22. In one embodiment, the pivot arms 16, 18 are dimensioned such that each distal end comes into general abutment with the exterior of the psoas muscle 304. That said, it is within the scope of the invention to provide the pivot arms 16, 18 such that each distal end extends downward into the psoas 304 towards the surgical target site (which may be advantageous from the standpoint of adding rigidity to the distal portions of the speculum blades 20, 22 for the purpose of facilitating the process of secondary tissue distraction). Once positioned over the speculum blades 20, 22, the handle assembly 24 may be operate to distract tissue from the position shown in FIG. 28 to that shown in FIG. 29.


As shown in FIG. 30, the first retractor 90 is then introduced into the distracted region, positioned adjacent to the posterior region of the disc space, and locked to the pivot linkage 14 via the locking assembly 32. At that point, the locking member 36 may be advanced via the tool 112 and engaged with the retractor blade 90 such that the middle region 108 resides at least partially within the passageway 102 and the distal region 110 extends into the disc space. Thereafter, as shown in FIG. 31, the retractor blade 92 may be introduced into the distracted region, positioned adjacent to the anterior region of the disc space, and locked to the pivot linkage 14 via the locking assembly 34. At that point, another locking member 36 may be engaged in the same fashion as with the retractor blade 90, with the distal region 110 extending into the disc space. As shown in FIG. 32, additional retractor blades 91, 93 may be coupled to the pivot linkage 14 to provide retraction in the caudal and cephalad directions, respectively.


The end result is shown in FIG. 33, wherein an operative corridor has been created to the spinal target site (in this case, the disc space) defined by the retractor blades 90, 92 (and optionally 91, 93). The distal regions 110 of the locking each locking member 36 advantageously extends into the disc space to prevent the ingress of tissue (e.g., neural, vasculature, etc. . . . ) into the surgical target site and/or operative corridor and the egress of instruments or implants out of the surgical target site and/or operative corridor.


In a further protective measure, each retractor blade 90, 92 is equipped with a guard member 114 to prevent similar ingress and egress. Both guard members 114 (as well as additional regions of the distal region 110 of the locking member 36) may be provided with electrodes 210, 212, respectively, capable of performing nerve surveillance to monitor for the existence of (and optionally the distance and direction to) nerves or neural structures in the tissue or region surrounding or adjacent to these components while disposed in the general vicinity of the surgical target site. The electrode 210 on the guard member 114 of the posterior retractor blade 90, in particular, may be used to assess the status or health of the nerve root 300, especially if the nerve root 300 is in close proximity to that guard member 114. This may be performed by using the nerve status determination systems or techniques disclosed in co-pending and commonly assigned U.S. Pat. No. 6,500,128, entitled “Nerve Proximity and Status Detection System and Method,” the entire contents of which is hereby incorporated by reference as is set forth fully herein.


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 steps of distraction followed by retraction are advantageous because they provide 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 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 working cannula 50, 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 trans-psoas surgical access system for accessing a spinal disc of a lumbar spine, comprising: a distraction assembly to create a trans-psoas distraction corridor to a lumbar spine, wherein said distraction assembly comprises: an elongate inner member configured to be delivered toward a spinal disc along a lateral, trans-psoas path to the lumbar spine, and a first dilator configured to be delivered to the spinal disc along the lateral, trans-psoas path to the lumbar spine, the first dilator having a passage configured to slidably receive the elongate inner member, wherein at least one instrument from the group consisting of the elongate inner member and the first dilator has a stimulation electrode situated at a distal end region thereof to deliver electrical stimulation for nerve monitoring when said stimulation electrode is positioned in the lateral, trans-psoas path to the lumbar spine; anda trans-psoas retraction assembly comprising: a blade holder apparatus, and a plurality of retractor blades configured to enlarge the trans-psoas distraction corridor and configured to maintain a trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine when the plurality of retractor blades are delivered to the lumbar spine, wherein the blade holder apparatus that is configured to retain the first and second retractor blades in an orientation in which the first retractor blade is spaced apart from the second retractor blade by a gap therebetween, wherein the plurality of retractor blades are sized and shaped to maintain the trans-psoas operative corridor that is so dimensioned to pass a spinal implant through the trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine, and wherein with a first retractor blade of the plurality of retractor blades defines a first channel that is fixedly positioned relative to a proximal end of the respective retractor blade and that is configured to slidably engage a first fixation member for anchoring to the lumbar spine, the first fixation member having a proximal portion with a proximal end, a distal portion extending from the proximal portion to a distal end, a length between the proximal end and distal end, a corridor facing surface and a blade facing surface, a thickness defined between the corridor facing surface and the blade facing surface, and a width, wherein the width is greater than the thickness, the fixation member being slidably advanceable along the channel to a position wherein the distal end extends distally from the retractor blade to anchor into the lumbar spine.
  • 2. The system of claim 1, wherein when the plurality of retractor blades are delivered to the lumbar spine, the distal portion of the first fixation member is adapted to anchor into the spinal disc between adjacent vertebral bodies and secures the first retractor blade relative to the adjacent vertebral bodies.
  • 3. The system of claim 1, wherein the retractor assembly further comprises a plurality of light emitting devices to direct light through the operative corridor toward the spinal disc, the plurality of light emitting devices being coupled to the plurality of retractor blades.
  • 4. The system of claim 1, wherein the plurality of retractor blades comprises the first retractor blade and a second retractor blade that is spaced apart from the first retractor blade when the plurality of retractor blades enlarge the tissue distraction corridor to form the trans-psoas operative corridor along the lateral, trans-psoas path to the lumbar spine.
  • 5. The system of claim 4, wherein the first retractor blade is a posterior-most retractor blade when the plurality of retractor blades are delivered to the lumbar spine, wherein the first fixation member is configured to slidably engage with the posterior-most blade and to anchor into the lumbar spine when the posterior-most blade is delivered to the lumbar spine.
  • 6. The system of claim 1, wherein the stimulation electrode of said at least one instrument comprises an exposed electrode surface positioned on a tapered distal tip portion of said at least one instrument.
  • 7. The system of claim 6, wherein the distraction assembly further comprises a second dilator having a larger diameter than the first dilator, the second dilator being advanceable over the first supplemental dilator along the lateral, trans-psoas path to the lumbar spine.
  • 8. The system of claim 7, wherein each of the elongate inner member, the first dilator, and the second dilator comprises a corresponding stimulation electrode positioned on a respective tapered distal tip portion of the respective one of the elongate inner member, the first dilator, and the second dilator.
  • 9. The system of claim 1, wherein the distraction assembly further comprises a secondary distraction assembly.
  • 10. The system of claim 9, wherein the secondary distraction assembly comprises a speculum instrument to prepare the trans-psoas distraction corridor for receipt of the plurality of retractor blades.
  • 11. The system of claim 1, wherein each retractor blade of the plurality of retractor blades is sequentially advanced along the lateral, trans-psoas path to the targeted spinal site.
  • 12. The system of claim 1, wherein each retractor blade of the plurality of retractor blades comprises a stimulation electrode to deliver electrical stimulation for nerve monitoring.
  • 13. The system of claim 1, further comprising a monitoring system that delivers an electrical stimulation signal to the stimulation electrode of said at least one instrument, monitors electromyographic activity detected by a set of sensor electrodes in muscle myotomes associated with nerves in the vicinity of the spinal disc, and displays a numeric stimulation threshold value in units of milliAmps which varies in response to the electromyographic activity detected by the set of sensor electrodes.
  • 14. The system of claim 13, wherein the monitoring system displays to the user the numeric stimulation threshold value in units of milliAmps while also contemporaneously displaying myotome levels being monitored, the numeric stimulation threshold being an electrical current value required to obtain a threshold level of electromyographic activity in at least one of said muscle myotomes.
  • 15. The system of claim 13, wherein the monitoring system comprises a control unit having a video display device, a patient module connected to the control unit via a data cable, an EMG sensor harness having the set of sensor electrodes connected to the patient module, and wherein the control unit receives signals from the patient module and processes EMG responses output from the sensor electrodes to extract characteristic information for each of said muscle myotomes.
  • 16. The system of claim 1, wherein the elongate inner member has a first length, and the first dilator has a second length less than the first length of the elongate inner member.
  • 17. The system of claim 1, wherein the elongate inner member comprises a guide wire instrument.
  • 18. The system of claim 1, wherein the plurality of retractor blades includes first and second retractor blades that each have a proximal connector region for mounting to the blade holder apparatus and an elongate blade body extending distally from the proximal connector region, wherein the elongate blade body of the first retractor blade has the same shape and maximum width as the elongate blade body of the second retractor blade.
  • 19. The system of claim 1, wherein the elongate inner member is configured to be simultaneously delivered with the first dilator toward the spinal disc along the lateral, trans-psoas path to the lumbar spine.
CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 13/757,035, filed Feb. 1, 2013, which is a continuation of U.S. patent application Ser. No. 13/466,398, filed May 8, 2012, which is a continuation of U.S. patent application Ser. No. 12/649,604 filed Dec. 30, 2009 (now U.S. Pat. No. 8,182,423), which is a continuation of U.S. patent application Ser. No. 12/635,418 filed Dec. 10, 2009 (now U.S. Pat. No. 8,192,356), which is a continuation of U.S. patent application Ser. No. 12/428,081, filed Apr. 22, 2009 (now U.S. Pat. No. 7,935,051), which is a continuation of U.S. patent application Ser. No. 10/608,362 filed Jun. 26, 2003 (now U.S. Pat. No. 7,582,058), which claims priority to U.S. Provisional Patent Application Ser. No. 60/392,214, filed Jun. 26, 2002, 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 co-assigned patent applications in their entireties: 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 (published as WO03/005887); PCT App. Ser. No. PCT/US02/30617, entitled “System and Methods for Performing Surgical Procedures and Assessments,” filed on Sep. 25, 2002 (published as WO 03/026482); PCT App. Ser. No. PCT/US02/35047, entitled “System and Methods for Performing Percutaneous Pedicle Integrity Assessments,” filed on Oct. 30, 2002 (published as WO/03037170); and PCT App. Ser. No. PCT/US03/02056, entitled “System and Methods for Determining Nerve Direction to a Surgical Instrument,” filed Jan. 15, 2003 (published as WO/2004064634).

US Referenced Citations (553)
Number Name Date Kind
208227 Dorr Sep 1878 A
509226 Kellogg Nov 1893 A
972983 Arthur Oct 1910 A
1003232 Cerbo Oct 1910 A
1044348 Cerbo Jun 1912 A
1328624 Graham Jan 1920 A
1548184 Cameron Aug 1925 A
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 Stark et al. Aug 1979 A
4207897 Lloyd et al. Jun 1980 A
4224949 Scott et al. Sep 1980 A
4226228 Shin et al. Oct 1980 A
4226288 Collins, Jr. Oct 1980 A
4235242 Howson et al. Nov 1980 A
4285347 Hess Aug 1981 A
4291705 Severinghaus et al. Sep 1981 A
4449532 Storz May 1984 A
4461300 Christensen Jul 1984 A
4512351 Pohndorf Apr 1985 A
4515168 Chester et al. May 1985 A
4519403 Dickhudt May 1985 A
4545374 Jacobson Oct 1985 A
4561445 Berke et al. Dec 1985 A
4562832 Wilder et al. Jan 1986 A
4573448 Kambin Mar 1986 A
4592369 Davis et al. Jun 1986 A
4595013 Jones Jun 1986 A
4595018 Rantala Jun 1986 A
4611597 Kraus Sep 1986 A
4616635 Caspar et al. Oct 1986 A
4633889 Talalla Jan 1987 A
4658835 Pohndorf Apr 1987 A
D295445 Freeman Apr 1988 S
4744371 Harris May 1988 A
4753223 Bremer Jun 1988 A
4759377 Dykstra Jul 1988 A
4784150 Voorhies et al. Nov 1988 A
4807642 Brown Feb 1989 A
D300561 Asa et al. Apr 1989 S
4892105 Prass Jan 1990 A
4913134 Luque Apr 1990 A
4917274 Asa et al. Apr 1990 A
4917704 Frey et al. Apr 1990 A
4926865 Oman May 1990 A
4950257 Hibbs et al. Aug 1990 A
4962766 Herzon Oct 1990 A
4964411 Johnson et al. Oct 1990 A
5007902 Witt Apr 1991 A
5015247 Michelson May 1991 A
5045054 Hood et al. Sep 1991 A
5052373 Michelson Oct 1991 A
5058602 Brody Oct 1991 A
5081990 Deletis Jan 1992 A
5092344 Lee Mar 1992 A
5127403 Brownlee Jul 1992 A
5161533 Prass et al. Nov 1992 A
5171279 Mathews Dec 1992 A
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 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 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 Jul 1998 A
5792044 Foley 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 et al. 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 et al. Nov 1999 A
5976146 Ogawa et al. Nov 1999 A
5993474 Ouchi Nov 1999 A
6004262 Putz et al. Dec 1999 A
6004312 Finneran 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 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 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 et al. 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, III Feb 2005 B2
6869398 Obenchain 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 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 Kaula et al. Apr 2009 B2
7556601 Branch et al. Jul 2009 B2
7582058 Miles et al. Sep 2009 B1
7643884 Pond et al. Jan 2010 B2
7691057 Miles et al. Apr 2010 B2
7693562 Marino et al. Apr 2010 B2
7717959 William et al. May 2010 B2
7819801 Miles et al. Oct 2010 B2
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 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 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 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
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
Foreign Referenced Citations (43)
Number Date Country
299 08 259 Jul 1999 DE
10048790 Oct 2000 DE
100 48 790 Apr 2002 DE
0 334 116 Sep 1989 EP
0 567 424 Oct 1993 EP
0 972 538 Jan 2000 EP
1 002 500 May 2000 EP
2 795 624 Jan 2001 FR
793186 May 1990 JP
10-14928 Mar 1996 JP
3019990007098 Nov 1999 KR
9428824 Dec 1994 WO
9700702 Jan 1997 WO
9823324 Jun 1998 WO
9952446 Oct 1999 WO
0027291 May 2000 WO
WO0027291 May 2000 WO
0038574 Jul 2000 WO
0044288 Aug 2000 WO
WO0062660 Oct 2000 WO
0066217 Nov 2000 WO
0067645 Nov 2000 WO
0108563 Feb 2001 WO
0137728 May 2001 WO
0160263 Aug 2001 WO
02054960 Jul 2002 WO
02058780 Aug 2002 WO
02071953 Sep 2002 WO
02087678 Nov 2002 WO
03005887 Jan 2003 WO
03026482 Apr 2003 WO
03037170 May 2003 WO
WO03084398 Oct 2003 WO
2005013805 Feb 2005 WO
2005030318 Apr 2005 WO
2006042241 Apr 2006 WO
2006066217 Jun 2006 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 (258)
Entry
INS-1 Guide, Dec. 31, 2000.
Anatomy of the Lumbar Spine in MED TM MicroEndoscopic Discectomy (1997 Ludann Grand Rapids MI), 14 pgs.
Dirksmeier et al., “Microendoscopic and Open Laminotomy and Discectomy in Lumbar Disc Disease” Seminars in Spine Surgery, 1999, 11(2): 138-146.
METRx Delivered Order Form, 1999, 13 pages.
Medtronic Sofamor Danek “METRx™ MicroDiscectomy System,” Medtronic Sofamor Danek USA, 2000, 21 pgs.
Medtronic Sofamor Danek “METRx System Surgical Technique,” 2004, 22 pages.
“MetRx System MicroEndoscopic Discectomy: An Evolution in Minimally Invasive Spine Surgery,” Sofamor Danek, 1999, 6 pages.
Smith and Foley “MetRx System MicroEndoscopic Discectomy: Surgical Technique” Medtronic Sofamor Danek, 2000, 24 pages.
“Sofamor Danek MED Microendoscopic Discectomy System Brochure” including Rapp “New endoscopic lumbar technique improves access preserves tissue” Reprinted with permission from: Orthopedics Today, 1998, 18(1): 2 pages.
Japanese Patent Office JP Patent Application No. 2006-528306 Office Action with English Translation, Jun. 10, 2009, 4 pages.
Plaintiffs' Preliminary Invalidity Contentions re 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.
Axon 501(k) Notification: Epoch 2000 Neurological Workstation, Dec. 3, 1997, 464 pages.
Foley and Smith, “Microendoscopic Discectomy,” Techniques in Neurosurgery, 1997, 3(4):301-307.
Medtronic Sofamor Danek “UNION™ / UNION-L™ Anterior & Lateral Impacted Fusion Devices: Clear choice of stabilization,” Medtronic Sofamor Danek, 2000, 4 pages.
NuVasive Vector™ Cannulae, 2000, 1 page.
NuVasive Triad Triad™ Tri-Columnar Spinal EndoArthrodesis™ via Minimally Invasive Guidance, 2000, 1 page (prior to Sep. 25, 2003).
NuVasive Triad™ Cortical Bone Allograft, 2000, 1 page (prior to Sep. 25, 2003).
NuVasive Vertebral Body Access System, 2000, 1 page.
Marina, “New Technology for Guided Navigation with Real Time Nerve Surveillance for Minimally Invasive Spine Discectomy & Arthrodesis,” Spineline, 2000, p. 39.
NuVasive “INS-1 Screw Test,” 2001, 10 pages.
NuVasive letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5 pages.
NuVasive letter re 510k Guided Arthroscopy System, Oct. 5, 1999, 6 pages.
NuVasive letter re 510k INS-1 Intraoperative Nerve Surveillance System, Nov. 13, 2000, 7 pages.
“NuVasive™ Receives Clearance to Market Two Key Elem Minimally Invasive Spine Surgery System,” Nov. 27, 2001, 20 pages.
Schick et al., “Microendoscopic lumbar discectomy versus open surgery: an intraoperative EMG study,” Eur Spine J, 2002, 11: 20-26.
NuVasive letter re: 510(k) for Neurovision JJB System (Summary), Sep. 25, 2001, 28 pages.
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Jul. 3, 2003, 18 pages.
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Mar. 1, 2004, 16 pages.
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), May 26, 2005, 17 pages.
NuVasive letter re: 510(k) Premarket Notification: Neurovision JJB System (Device Description), Jun. 24, 2005, 16 pages.
NuVasive letter re: Special 510(k) Premarket Notification: Neurovision JJB System (Device Description), Sep. 14, 2006, 17 pages.
NuVasive 510(k) Premarket Notification: Neurovision JJB System (Device Description), Aug. 20, 2007, 8 pages.
NuVasive letter re: 510(k) Premarket Notification: Guided Spinal Arthroscopy System (Device Description), Feb. 1, 1999, 40 pages.
NuVasive 510(k) Premarket Notification: Spinal System (Summary), Apr. 12, 2004, 10 pages.
NuVasive 510(k) Summary NIM Monitor, Sep. 4, 1998, 4 pages.
NuVasive correspondence re 510(k) Premarket Notification INS-1 Intraoperative Nerve Surveillance System: Section IV Device Description, pp. 12-51 (prior to Sep. 25, 2003).
Isley et al., “Recent Advances in Intraoperative Neuromonitoring of Spinal Cord Function: Pedicle Screw Stimulation Techniques,” American Journal of Electroneurodiagnostic Technology, Jun. 1997, 37(2):93-126.
Mathews et al., “Laparoscopic Discectomy with Anterior Lumbar Interbody Fusion,” SPINE, 1995, 20(16): 1797-1802.
Rose et al., “Persistently Electrified Pedicle Stimulation Instruments in Spinal Instrumentation: Techniques and Protocol Development,” SPINE, 1997, 22(3): 334-343.
“Electromyography System,” International Search report from International Application No. PCT/US00/32329, Apr. 27, 2001, 9 pages.
“Nerve Proximity and Status Detection System and Method,” International Search Report from International Application No. PCT/US01/18606, Oct. 18, 2001, 6 pages.
“Relative Nerve Movement and Status Detection System and Method,” International Search Report from International Application No. PCT/US01/18579, Jan. 15, 2002, 6 pages.
“System and Method for Determining Nerve Proximity Direction and Pathology During Surgery,” International Search Report from International Application No. PCT/US02/22247, Mar. 27, 2003, 4 pages.
“System and Methods for Determining Nerve Direction to a Surgical Instrument,” International Search Report from International Application No. PCT/US03/02056, Aug. 12, 2003, 5 pages.
“Systems and Methods for Performing Percutaneous Pedicle Integrity Assessments,” International Search Report from International Application No. PCT/US02/35047, Aug. 11, 2003, 5 pages.
“Systems and Methods for Performing Surgery Procedures and Assessments,” International Search Report from International Application No. PCT/US02/30617, Jun. 5, 2003, 4 pages.
Lenke et al., “Triggered Electromyographic Threshold for Accuracy of Pedicle Screw Placement,” Spine, 1995, 20(4): 1585-1591.
“Brackmann II EMG System,” Medical Electronics, 1999, 4 pages.
“Neurovision SE Nerve Locator/Monitor”, RLN Systems Inc. Operators Manual, 1999, 22 pages.
“The Brackmann II EMG Monitoring System,” Medical Electronics Co. Operator's Manual Version 1.1, 1995, 50 pages.
“The Nicolet Viking IV,” Nicolet Biomedical Products, 1999, 6 pages.
Anderson et al., “Pedicle screws with high electrical resistance: a potential source of error with stimulus-evoked EMG,” Spine, Department of Orthopaedic Surgery University of Virginia, Jul. 15, 2002, 27(14): 1577-1581.
Bose et al., “Neurophysiologic Monitoring of Spinal Nerve Root Function During Instrumented Posterior Lumber Spine Surgery,” Spine, 2002, 27(13):1444-1450.
Calancie et al., “Stimulus-Evoked EMG Monitoring During Transpedicular Lumbosacral Spine Instrumentation” Spine, 1994, 19(24): 2780-2786.
Clements et al., “Evoked and Spontaneous Electromyography to Evaluate Lumbosacral Pedicle Screw Placement,” Spine, 1996, 21(5): 600-604.
Danesh-Clough et al. ,“The Use of Evoked EMG in Detecting Misplaced Thoracolumbar Pedicle Screws,” Spine, Orthopaedic Department Dunedin Hospital, Jun. 15, 2001, 26(12): 1313-1316.
Darden et al., “A Comparison of Impedance and Electromyogram Measurements in Detecting the Presence of Pedicle Wall Breakthrough,” Spine, Charlotte Spine Center North Carolina, Jan. 15, 1998, 23(2): 256-262.
Ebraheim et al., “Anatomic Relations Between the Lumbar Pedicle and the Adjacent Neural Structures,” Spine, Department of Orthopaedic Surgery Medical College of Ohio, Oct. 15, 1997, 22(20): 2338-2341.
Ford et al. “Electrical Characteristics of Peripheral Nerve Stimulators Implications for Nerve Localization,” Regional Anesthesia, 1984, 9: 73-77.
Glassman et al., “A Prospective Analysis of Intraoperative Electromyographic Monitoring of Pedicle Screw Placement With Computed Tomographic Scan Confirmation,” Spine, 1995, 20(12): 1375-1379.
Greenblatt et al., “Needle Nerve Stimulator-Locator: Nerve Blocks with a New Instrument for Locating Nerves,” Anesthesia& Analgesia, 1962, 41(5): 599-602.
Haig, “Point of view,” Spine, 2002, 27(24): 2819.
Haig et al., “The Relation Among Spinal Geometry on MRI, Paraspinal Electromyographic Abnormalities, and Age in Persons Referred for Electrodiagnostic Testing of Low Back Symptoms,” Spine, Department of Physical Medicine and Rehabilitation University of Michigan, Sep. 1, 2002, 27(17): 1918-1925.
Holland et al., “Higher Electrical Stimulus Intensities are Required to Activate Chronically Compressed Nerve Roots: Implications for Intraoperative Electromyographic Pedicle Screw Testing,” Spine, Department of Neurology, Johns Hopkins University School of Medicine, Jan. 15, 1998, 23(2): 224-227.
Holland, “Intraoperative Electromyography During Thoracolumbar Spinal Surgery,” Spine, 1998, 23(17): 1915-1922.
Journee et al., “System for Intra-Operative Monitoring of the Cortical Intgegrity of the Pedicle During Pedicle Screw Placement in Low-Back Surgery: Design and Clinical Results,” Sensory and Neuromuscular Diagnostic Instrumentation and Data Analysis I, 18th Annual International Conference on Engineering in Medicine and Biology Society, Amsterdam, 1996, pp. 144-145.
Maguire et al., “Evaluation of Intrapedicular Screw Position Using Intraoperative Evoked Electromyography,” Spine, 1995, 20(9): 1068-1074.
Martin et al. “Initiation of Erection and Semen Release by Rectal Probe Electrostimulation (RPE),” The Journal of Urology, The Williams& Wilkins Co., 1983, 129: 637-642.
Minahan et al., “The Effect of Neuromuscular Blockade on Pedicle Screw Stimulation Thresholds” Spine, Department of Neurology, Johns Hopkins University School of Medicine, Oct. 1, 2000, 25(19): 2526-2530.
Pither et al., “The Use of Peripheral Nerve Stimulators for Regional Anesthesia: Review of Experimental Characteristics Technique and Clinical Applications,” Regional Anesthesia, 1985, 10:49-58.
Raj et al., “Infraclavicular Brachial Plexus Block—A New Approach” Anesthesia and Analgesia, 1973, (52)6: 897-904.
Raj et al., “The Use of Peripheral Nerve Stimulators for Regional Anesthesia,” Clinical Issues in Regional Anesthesia, 1985, 1(4):1-6.
Raj et al., “Use of the Nerve Stimulator for Peripheral Blocks,” Regional Anesthesia, Apr.-Jun. 1980, pp. 14-21.
Raymond et al., “The Nerve Seeker: A System for Automated Nerve Localization,” Regional Anesthesia, 1992, 17(3): 151-162.
Shafik, “Cavernous Nerve Simulation through an Extrapelvic Subpubic Approach: Role in Penile Erection,” Eur. Urol, 1994, 26: 98-102.
Toleikis et al., “The Usefulness of Electrical Stimulation for Assessing Pedicle Screw Replacements,” Journal of Spinal Disorder, 2000, 13(4): 283-289.
Medtronic Sofamor Danek “UNION™ / UNION-L™ Anterior & Lacteral Impacted Fusion Devices: Surgical Technique” Medtronic Sofamor Danek, 2001, 20 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.
Bergey et al., “Endoscopic Lateral Transpsoas Approach to the Lumbar Spine,” Spine, 2004, 29(15): 1681-1688.
Dezawa et al., “Retroperitoneal Laparoscopic Lateral Approach to the Lumbar Spine: A New Approach, Technique, and Clinical Trial,” Journal of Spinal Disorders, 2000, 13(2): 138-143.
Gardocki, “Tubular diskectomy minimizes collateral damage: A logical progression moves spine surgery forward,” AAOS Now, 2009, 5 pages.
Hovorka et al., “Five years' experience of retroperitoneal lumbar and thoracolumbar surgery,” Eur Spine J., 2000, 9(1): S30-S34.
Kossmann et al., “The use of a retractor system (SynFrame) for open, minimal invasive reconstruction of the anterior column of the thoracic and lumbar spine,” Eur Spine J., 2001, 10: 396-402.
Mayer, “A New Microsurgical Technique for Minimally Invasive Anterior Lumbar Interbody Fusion,” Spine, 1997, 22(6): 691-699.
Mayer, “The ALIF Concept,” Eur Spine J., 2000, 9(1): S35-S43.
Mayer and Wiechert, “Microsurgical Anterior Approaches to the Lumbar Spine for Interbody Fusion and Total Disc Replacement,” Neurosurgery, 2002, 51(2): 159-165.
McAfee et al., “Minimally Invasive Anterior Retroperitoneal Approach to the Lumbar Spine: Emphasis on the Lateral BAK,” Spine, 1998, 23(13): 1476-1484.
Rao, et al. “Dynamic retraction of the psoas muscle to expose the lumbar spine using the retroperitoneal approach,” J. Neurosurg Spine, 2006, 5: 468-470.
Wolfla et al., “Retroperitoneal lateral lumbar interbody fusion with titanium threaded fusion cages,” J. Neurosurg (Spine 1), 2002, 96: 50-55.
Larson and Maiman, “Surgery of the Lumbar Spine,” Thieme Medical Publishers, Inc., 1999, pp. 305-319.
Medtronic XOMED Surgical Products, Inc., NIM-Response Nerve Integrity Monitor Intraoperative EMG Monitor User's Guide, Revision B, 2000, 47 pages.
“NuVasive's spine surgery system cleared in the US,” Pharm & Medical Industry Week, Dec. 10, 2001, 1 page.
Pimenta, “Initial Clinical Results of Direct Lateral, Minimally Invasive Access to the Lumbar Spine for Disc Nucleus Replacement Using a Novel Neurophysiological Monitoring System.” The 9th IMAST, May 2002, 1 page.
Pimenta et al., “The Lateral Endoscopic Transpsoas Retroperitoneal Approach (Letra) for Implants in the Lumbar Spine,” World Spine II—Second Interdisciplinary Congress on Spine Care, Aug. 2003, 2 pages.
Crock, H.V. MD., “Anterior Lumbar Interbody Fusion,” Clinical Orthopaedics and Related Research, No. One Hundred Sixty Five, 1982, pp. 157-163, 13 pages.
Mayer and Brock, “Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy,” J. Neurosurg, 1993, 78: 216-225.
Schaffer and Kambin, “Percutaneous Posterolateral Lumbar Discectomy and Decompression with a 6.9-Millimeter Cannula,” The Journal of Bone and Joint Surgery, 1991, 73A(6): 822-831.
Friedman, “Percutaneous discectomy: An alternative to chemonucleolysis,” Neurosurgery, 1983, 13(5): 542-547.
Request for Inter PartesReexamination in re U.S. Pat. No. 7,905,840, dated Feb. 8, 2012, 204 pages.
Brau, “Chapter 22: Anterior Retroperitoneal Muscle-Sparing approach to L2-S1 of the Lumbar Spine,” Surgical Approaches to the Spine. Robert G. Watkins, MD. (ed) 2003. pp. 165-181.
Kossmann et al., “Minimally Invasive Vertebral Replacement with Cages in Thoracic and Lumbar Spine,” European Journal of Trauma, 2001, 27: 292-300.
Mayer H. M. (ed.) Minimally Invasive Spine Surgery: A Surgical Manual. 2000. 51 pages.
Pimenta et al., “Implante de protese de nucleo pulposo: analise inicial,” Journal Brasileiro de Neurocirurgia, 2001, 12(2): 93-96.
Traynelis, “Spinal Arthroplasty,” Neurological Focus, 2002, 13(2): 12 pages.
Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999. 43 pages.
Amended Complaint for NuVasive, Inc. v. Globus Medical, Inc., Case No. 1:10-cv-0849 (D. Del., Oct. 5, 2010), 28 pages.
Request for Inter PartesReexamination In re U.S. Pat. No. 7,819,801, dated Feb. 8, 2012, 89 pages.
Kossman et al., “The use of a retractor system (SynFrame) for open, minimal invasive reconstruction of the anterior column of the thoracic and lumbar spine,” Eur Spine J, 2001, 10: 396-402.
De Peretti et al., “New possibilities in L2-L5 lumbar arthrodesis using a lateral retroperitoneal approach assisted by laparoscopy: preliminary results,” Eur Spine J, 1996, 5: 210-216.
Litwin et al., “Hand-assisted laparoscopic surgery (HALS) with the handport system,” Annals of Surgery, 2000, 231(5): 715-723.
Acland's Video Atlas of Human Anatomy, Section 3.1.7: Paravertebral Muscles. Available online: http://aclandanatomy.com/abstract/4010463. Accessed Jul. 11, 2012.
MedlinePlus, a Service of the U.S. National Library of Medicine and National Institutes of Health. Available online: http://www.nlm.nih.gov/medlineplus/. Accessed Jul. 11, 2012.
Baulot et al., Adjuvant Anterior Spinal Fusion Via Thoracoscopy, Lyon Chirurgical, 1994, 90(5): 347-351 including English Translation and Certificate of Translation.
Leu et al., “Percutaneous Fusion of the Lumbar Spine,” Spine, 1992, 6(3): 593-604.
Rosenthal et al., “Removal of a Protruded Thoracic Disc Using Microsurgical Endoscopy,” Spine, 1994, 19(9): 1087-1091.
Counterclaim Defendants' Corrected Amended Invalidity Contentions re U.S. 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.
Petition for Inter Partes Review IPR2014-00034, filed Oct. 8, 2013, 65 pages.
Petition for Inter Partes Review IPR2014-00035, filed Oct. 8, 2013, 65 pages.
Declaration of Lee Grant, from IPR2014-00034, Oct. 7, 2013, 36 pages.
Declaration of David Hacker from IPR2014-00034, Oct. 4, 2013, 64 pages.
NuVasive, Inc's Opening Claim Construction Brief Regarding U.S. 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; 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.
Petition for Inter Partes Review IPR2014-00073, filed Oct. 18, 2013, 65 pages.
Petition for Inter Partes Review IPR2014-00074, filed Oct. 18, 2013, 65 pages.
Petition for Inter Partes Review IPR2014-00075, filed Oct. 21, 2013, 66 pages.
Petition for Inter Partes Review IPR2014-00076, filed Oct. 21, 2013, 65 pages.
Petition for Inter Partes Review IPR2014-00081, filed Oct. 22, 2013, 64 pages.
Petition for Inter Partes Review IPR2014-00087, filed Oct. 22, 2013, 64 pages.
Declaration of Lee Grant, from IPR2014-00073, Oct. 9, 2013, 36 pages.
Declaration of David Hacker, from IPR2014-00073, Oct. 10, 2013, 64 pages.
U.S. Appl. No. 60/392,214, filed Jun. 26, 2002, 97 pages.
Amendment in reply to Feb. 15, 2012 Office Action in U.S. Appl. No. 12/635,418, dated Mar. 16, 2012, 24 pages.
Decision on Appeal in Inter Partes Reexamination Control No. 95/001,247, dated Mar. 18, 2013, 49 pages.
Declaration of Lee Grant, from IPR2014-00074, Oct. 9, 2013, 36 pages.
Declaration of David Hacker, from IPR2014-00074, Oct. 10, 2013, 64 pages.
Declaration of David Hacker, from IPR2014-00075, Oct. 10, 2013, 64 pages.
Amendment in reply to Action of Feb. 7, 2011 and Notice of May 12, 2011, in U.S. Appl. No. 11/789,284, dated May 17, 2011, 16 pages.
Notice of Allowance in U.S. Appl. No. 11/789,284, dated Jul. 18, 2011, 8 pages.
Office action from U.S. Appl. No. 11/789,284, dated Feb. 7, 2011, 10 pages.
Merriam-Webster's Collegiate Dictionary, p. 65 (10th ed. 1998).
Declaration of Lee Grant, from IPR2014-00076, Oct. 9, 2013, 36 pages.
Moed et al., “Evaluation of Intraoperative Nerve-Monitoring During Insertion of an Iliosacral Implant in an Animal Model, Journal of Bone and Joint Surgery,” 1999, 81-A(11): 9.
Declaration of Lee Grant, from IPR2014-0081, Oct. 9, 2013, 36 pages.
Declaration of David Hacker from IPR2014-00081, Oct. 10, 2013, 64 pages.
U.S. Appl. No. 60/325,424, filed Sep. 25, 2001, 346 pages.
Declaration of Lee Grant, from IPR2014-0087, Oct. 9, 2013, 36 pages.
Declaration of David Hacker from IPR2014-00087, Oct. 10, 2013, 64 pages.
Request for Inter Partes Reexamination In re: U.S. Pat. No. 7,691,057, dated Feb. 8, 2012, 50 pages.
Declaration of Daniel Schwartz, Ph.D. from IPR2014-00034, Oct. 7, 2013, 1056 pages.
Declaration of Daniel Schwartz, Ph.D. from IPR2014-00035, Oct. 7, 2013, 661 pages.
510(K) No. K002677, approved by the FDA on Nov. 13, 2000, 634 pages.
510(K) No. K013215, approved by the FDA on Oct. 16, 2001, 376 pages.
Declaration of Robert G. Watkins, from IPR2014-00073, Oct. 18, 2013, 1101 pages.
Declaration of Daniel Schwartz, from IPR2014-00073, Oct. 12, 2013, 1226 pages.
Declaration of Robert G. Watkins, from IPR2014-00074, Oct. 18, 2013, 548 pages.
Declaration of Daniel Schwartz, from IPR2014-00074, Oct. 12, 2013, 565 pages.
Declaration of Robert G. Watkins, from IPR2014-00075, Oct. 18, 2013, 674 pages.
Declaration of Daniel Schwartz, from IPR2014-00075, Oct. 12, 2013, 1107 pages.
Declaration of Robert G. Watkins, from IPR2014-00076, Oct. 18, 2013, 543 pages.
Declaration of Daniel Schwartz, from IPR2014-00076, Oct. 12, 2013, 1247 pages.
Declaration of David Hacker, from IPR2014-00076, Oct. 10, 2013, 64 pages.
Declaration of Daniel Schwartz, from IPR2014-0081, Oct. 21, 2013, 585 pages.
Declaration of Daniel Schwartz from IPR2014-0087, Oct. 21, 2013, 585 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00034, dated Jan. 15, 2014, 66 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00034, dated Apr. 8, 2014, 35 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00035, dated Jan. 15, 2014, 42 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00035, dated Apr. 8, 2014, 12 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00073, dated Jan. 31, 2014, 46 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00073, dated Apr. 8, 2014, 34 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00074, dated Jan. 31, 2014, 68 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00074, dated Apr. 8, 2014, 28 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00075, dated Jan. 31, 2014, 54 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00075, dated Apr. 8, 2014, 23 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00076, dated Jan. 31, 2014, 58 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00076, dated Apr. 8, 2014, 11 pages.
Patent Owner NuVasive Inc's Preliminary Response from IPR2014-00081, dated Jan. 31, 2014, 47 pages.
Patent Trial and Appeal Board Decision from IPR 2014-00081, dated Apr. 8, 2014, 31 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 2014-00087, dated Apr. 8, 2014, 31 pages.
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.
U.S. Appl. No. 15/445,854, Miles et al.
U.S. Appl. No. 15/448,395, Miles; Patrick. et al.
U.S. Appl. No. 15/498,296, Arnold; Benjamin. et al.
U.S. Appl. No. 15/424,492, Gharib; James E. et al.
U.S. Appl. No. 15/424,612, Gharib; James E. et al.
U.S. Appl. No. 15/439,889, Miles; Patrick. et al.
U.S. Appl. No. 90/013,464, Warsaw Orthopedic; Inc. et al.
U.S. Appl. No. 95/001,888, Nuvasive; Inc. et al.
U.S. Appl. No. 95/001,890, Nuvasive; Inc. et al.
U.S. Appl. No. 90/013,546, Warsaw Orthopedic; Inc. et al.
U.S. Appl. No. 90/013,605, Nuvasive; Inc. et al.
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.
In re: NuVasive, Inc. in 15-1670 filed May 20, 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.
In re: NuVasive, Inc. in 15-1672 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.
In re: NuVasive, Inc. in 15-1673 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.
In re: NuVasive, Inc. in 15-1838 filed Jul. 16, 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.
In re: NuVasive, Inc. in 15-1839 filed Jul. 16, 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.
In re: NuVasive, Inc. in 15-1840 filed Jul. 16, 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.
In re: NuVasive, Inc. in 15-1841 filed Jul. 16, 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.
In re: NuVasive, Inc. in 15-1842 filed Jul. 16, 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.
In re: NuVasive, Inc. in 15-1843 filed Jul. 16, 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.
In re: Warsaw Orthopedic, Inc. in 15-1050 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.
In re: Warsaw Orthopedic, Inc. in 15-1058 filed Oct. 17, 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.
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 Jul. 24, 2012 for International Application No. PCT/US2012/022600.
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.
Notice of Allowance dated Apr. 12, 2017 for U.S. Appl. No. 15/272,071.
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.
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. 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.
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 IPR2014-00071 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.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 12-1263 filed Mar. 15, 2012, 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.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 12-1266 filed Mar. 15, 2012, 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.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 13-1576 filed Aug. 21, 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.
Warsaw Orthopedic, Inc. v. NuVasive, Inc. in 13-1577 filed Aug. 21, 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.
Related Publications (1)
Number Date Country
20140235950 A1 Aug 2014 US
Provisional Applications (1)
Number Date Country
60392214 Jun 2002 US
Continuations (6)
Number Date Country
Parent 13757035 Feb 2013 US
Child 14263797 US
Parent 13466398 May 2012 US
Child 13757035 US
Parent 12649604 Dec 2009 US
Child 13466398 US
Parent 12635418 Dec 2009 US
Child 12649604 US
Parent 12428081 Apr 2009 US
Child 12635418 US
Parent 10608362 Jun 2003 US
Child 12428081 US