US20220079495A1 - Insulated Pedicle Access System and Related Methods - Google Patents
Insulated Pedicle Access System and Related Methods Download PDFInfo
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- US20220079495A1 US20220079495A1 US17/532,161 US202117532161A US2022079495A1 US 20220079495 A1 US20220079495 A1 US 20220079495A1 US 202117532161 A US202117532161 A US 202117532161A US 2022079495 A1 US2022079495 A1 US 2022079495A1
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- cannula
- stylet
- pedicle
- access system
- handle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/389—Electromyography [EMG]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4887—Locating particular structures in or on the body
- A61B5/4893—Nerves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
- A61B2017/00469—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B2017/347—Locking means, e.g. for locking instrument in cannula
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
- A61B5/4504—Bones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
Definitions
- the present invention relates to a system and methods aimed at accessing a pedicle in preparation for the placement of pedicle screws.
- Some attempts to minimize the risk of a pedicle breach involve capitalizing on the insulating characteristics of bone and the conductivity of the exiting nerve roots themselves to perform pedicle integrity assessments. That is, if the wall of the pedicle is breached, a stimulation signal applied to the pedicle screw and/or the pilot hole (prior to screw introduction) will cause the various muscle groups coupled to the exiting nerve roots to contract. If the pedicle wall has not been breached, the insulating nature of the pedicle will prevent the stimulation signal from innervating the given nerve roots such that the associated muscle groups will not twitch. Traditional EMG monitoring systems may be employed to augment the ability to detect such innervation.
- initial access to a pedicle may be achieved by inserting a needle to the target site and driving the needle point into the pedicle, creating a pilot hole. Due to the size and shape of the typical needle, however, manipulation and maneuvering of the needle may be awkward or difficult, increasing the risk of complication. Additionally, the pedicle may be breached and nerve damage done during the initial drive of the needle into the pedicle, before a pedicle integrity test assessment may be performed.
- an electrified needle may exhibit a threshold stimulation of approximately 5-6 mA, while a bone screw placed in the same location may exhibit a threshold stimulation of approximately 16-20 mA. This can be problematic in that an electrified needle may tend to indicate a breach in the pedicle wall when in fact the pedicle wall is intact.
- the present invention is directed at eliminating, or at least improving upon, the shortcomings of the prior art.
- the present invention provides a pedicle access system that facilitates ease of handling and can achieve dynamic pedicle integrity testing while forming a pilot hole.
- the pedicle access system includes a cannula, a stylet, and a removable T-handle.
- the pedicle access system of the present invention may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during the pilot hole formation.
- the cannula and stylet are locked in combination and inserted through an operating corridor to the pedicle target site, using the T-handle to facilitate easy movement and positioning of the cannula/stylet combination.
- a stimulation signal may be applied during pilot hole formation to conduct the pedicle integrity assessment.
- the T-handle may be detached from the cannula/stylet combination to facilitate the use of various surgical tools as necessary.
- the cannula includes a coupling element and an elongated shaft.
- An interior lumen extends through the cannula from a first opening in the coupling element to a second opening in the distal region of the elongated shaft.
- the elongated shaft may be composed of a conductive material, such as metal.
- a polymeric coating blankets or otherwise encapsulates a majority of the exterior surface of the elongated shaft, such that the elongated shaft includes an insulated region and an uninsulated region.
- the elongated shaft may incorporate one or more diameter changes along its length.
- the coupling element comprises three sections.
- a proximal region is dimensioned to engage with the stylet.
- the proximal region may also include at least one tab member protruding in a generally lateral direction. The tab member functions to lock the cannula and stylet in position together.
- a center section is dimensioned to engage with the T-handle. At least one cutout may be provided in the exterior surface of the center section. The cutout functions to secure the T-handle to the cannula/stylet combination, or optionally to the cannula only.
- the stylet comprises a locking cap and a needle element.
- the locking cap has a similar size and shape as the center section.
- the locking cap contains a generally cylindrical aperture dimensioned to receive the generally cylindrical top section of the cannula.
- the locking cap includes at least one longitudinal channel and at least one lateral channel that interact with the tab member as a means to secure the stylet and cannula in place.
- the longitudinal channel has a length dimension corresponding to the length of the generally cylindrical aperture and a width dimension sufficient to accommodate the length of the tab member.
- the lateral channel extends generally perpendicularly from the proximal end of the longitudinal channel, such that together the channels form a generally half-T shape.
- the longitudinal channel and the lateral channel, along with a ridge positioned on at least one edge of the lateral channel interact with the tab member on the cannula to lock the stylet and cannula together.
- the locking cap may include a ramped surface to facilitate engagement with the T-handle.
- the proximal portion of the needle element may be attached to the interior of the locking cap.
- the elongated shaft of the needle element extends distally from the proximal portion, with a significant portion protruding from the opening of the generally cylindrical aperture.
- the needle element is dimensioned to be inserted through the interior lumen of the cannula. When fully inserted, a distal portion of the needle element may protrude slightly from the bottom opening of the cannula.
- the needle element may be composed of a conductive material, such as metal, or a non-conductive material with one or more embedded conductive elements at or near the distal end capable of being communicatively linked with a pedicle integrity testing system.
- the needle element is inserted into the interior lumen of the cannula through the opening in the coupling element.
- the locking cap is positioned such that its longitudinal channels are aligned with the tab members of the cannula.
- the proximal region of the cannula is received into the aperture on the locking cap, and the tab members pass through the longitudinal channels. Insertion is complete when the proximal region is fully received by the aperture, leaving the locking cap in an “unlocked” position.
- the tab members are positioned at the proximal ends of the longitudinal channels. In this position the locking cap and center section of the cannula are not aligned.
- the locking cap is rotated until it is aligned with the center section.
- the ridges may be deformed when they contact the tab members.
- the ridges may clear the tab members and regain their original forms, thereby preventing inadvertent rotation back to the unlocked position.
- the T-handle includes a grip region, an aperture for engaging the cannula or cannula/stylet combination, and a locking mechanism for securing the T-handle to the cannula.
- the T-handle aperture is dimensioned to snugly receive both the locking cap and the center section of the cannula when they are aligned in the locked position.
- the locking mechanism preferably comprises a lever having one end integrated into the aperture wall and a free end extending therefrom. The majority of the lever (excluding the free end) may be the same thickness as the aperture wall and does not protrude, interiorly or exteriorly, from the aperture wall. In its “natural” state, the free end does protrude into the aperture space.
- the free end is dimensioned to engage the cutout in the center section of the cannula.
- the interior surface of the free end may be slightly ramped.
- the ramped portion works in concert with the ramped surface of the locking cap to force the free end out of its natural state so the locking cap and the center section can fit into the T-handle aperture.
- the locking mechanism aligns with the cutout in the cannula, returns to its natural state, and locks the T-handle to the cannula.
- the T-handle may be cannulated.
- the pedicle access system may be provided with a stylet, a cannula and a lock collar. Any part of the stylet and/or cannula may be coated with a nonconductive insulative coating to prevent shunting of electrical current.
- the pedicle access system may be provided with a retractable insulation sheath dimensioned to cover the electrically conductive cannula and stylet needle.
- the retractable insulation sheath is adapted to electrically insulate the pedicle access system as it is advanced along an operative corridor to a bony structure.
- the insulation sheath retracts to remain outside the bone and prevent electrical current intended for the pilot hole from shunting to surrounding tissue.
- the pedicle access system may be used in combination with neurophysiology monitoring systems and methods to conduct pedicle integrity assessments while achieving initial access to the pedicle and forming a pilot hole.
- the neurophysiology system performs pedicle integrity assessments by determining the amount of electrical communication between a stimulation signal and the adjacent nerve root.
- the pedicle access system may be coupled with the neurophysiology system by attaching an electric coupling device to the uninsulated region of the cannula.
- the pedicle access system may be used in cooperation with spinal fixation systems that require access to pedicle target sites and need pilot holes, as the cannula may be used to guide parts of the surgical fixation system to the target site.
- FIG. 1 is a plan view of an example of a pedicle access system according to one embodiment of the present invention
- FIG. 2 is a perspective view of a cannula forming part of the pedicle access system of FIG. 1 ;
- FIG. 3 is a perspective view of a coupling element forming part of the cannula of FIG. 2 ;
- FIG. 4 is a perspective view of a stylet forming part of the pedicle access system of FIG. 1 ;
- FIG. 5 is a perspective view of a locking cap forming part of the stylet of FIG. 4 ;
- FIG. 6 is a perspective view of the distal portion of the stylet of FIG. 4 protruding from the distal region of the cannula of FIG. 2 ;
- FIG. 7 is a perspective view of the distal portion of the stylet of FIG. 4 protruding from the distal region of the cannula of FIG. 2 , with the distal region of the cannula having an uninsulated portion;
- FIG. 8 is a perspective view of the distal portion of the stylet of FIG. 4 protruding from the distal region of the cannula of FIG. 2 , with the distal region of the cannula having a directional electrode;
- FIGS. 9-10 are plan and perspective views, respectively, of the stylet of FIG. 4 partially inserted into the cannula of FIG. 2 ;
- FIG. 11 is a is a plan view of the stylet of FIG. 4 fully inserted into the cannula of FIG. 2 in an unlocked position;
- FIG. 12 is perspective view of the locking cap of the fully inserted stylet of FIG. 11 , shown in an unlocked position;
- FIG. 13 is a perspective view of the cannula and stylet combination in the unlocked position of FIG. 11 ;
- FIGS. 14-15 are perspective and plan views, respectively, of the cannula and stylet combination of FIG. 13 in the locked position;
- FIGS. 16-17 are perspective views of a T-handle forming part of the pedicle access system of FIG. 1 ;
- FIG. 18 is a perspective view of the pedicle access system of FIG. 1 with the cannula and stylet combination of FIG. 13 fully inserted and locked in the T-handle;
- FIG. 19 is an exploded perspective view of a pedicle access system according to an alternative embodiment of the present invention.
- FIG. 20 is a perspective view of the assembled pedicle access system of FIG. 19 ;
- FIGS. 21-22 are plan and perspective views, respectively, of a cannula forming part of the pedicle access system of FIG. 20 ;
- FIGS. 23-24 are plan and perspective views, respectively, of a coupling element forming part of the cannula of FIG. 21 ;
- FIG. 25 is a perspective view of a stylet forming part of the pedicle access system of FIG. 20 ;
- FIG. 26 is a perspective view of a handle forming part of the stylet of FIG. 25 ;
- FIG. 27 is a perspective view of the pedicle access system of FIG. 20 including an enlarged view of a distal region thereof;
- FIGS. 28-30 are perspective, top plan and bottom plan views, respectively, of a lock collar forming part of the pedicle access system of FIG. 20 ;
- FIG. 31 is an exploded perspective view of a pedicle access system according to a further alternative embodiment of the present invention.
- FIGS. 32-33 are perspective views of an assembled pedicle access system of FIG. 31 ;
- FIG. 34 is a front view of the pedicle access system of FIG. 32 ;
- FIGS. 35-36 are side and perspective views, respectively, of a cannula forming part of the pedicle access system of FIG. 31 ;
- FIGS. 37-38 are side and perspective views, respectively, of a coupling element forming part of the cannula of FIG. 35 ;
- FIG. 39 is a perspective view of a stylet forming part of the pedicle access system of FIG. 31 ;
- FIG. 40 is a perspective view of a needle forming part of the stylet of FIG. 39 ;
- FIGS. 41-42 are perspective and plan views, respectively, of a handle forming part of the stylet of FIG. 39 ;
- FIGS. 43-44 are perspective and plan views, respectively, of a lock collar forming part of the pedicle access system of FIG. 31 ;
- FIG. 45 is a bottom plan view of a handle of FIG. 46 in engagement with a lock collar of FIG. 43 ;
- FIG. 46 is a perspective view of a retractable insulation sheath forming part of the pedicle access system of FIG. 31 ;
- FIG. 47 is a perspective view of an insulation tube forming part of the retractable insulation sheath of FIG. 46 ;
- FIG. 48 is a perspective view of a retraction tube forming part of the retractable insulation sheath of FIG. 46 ;
- FIGS. 49-50 are perspective views of a sheath attachment element forming part of the pedicle access system of FIG. 31 ;
- FIG. 51 is a perspective view of an example of a neurophysiology system capable of connecting to the pedicle access systems of FIGS. 1, 19 and 31 to conduct pedicle integrity tests.
- FIGS. 52-53 are side and perspective views, respectively, of a cannula forming part of the pedicle access system of FIG. 51 ;
- FIG. 53A are cross-sectional views taken along lines 53 A- 53 A in FIG. 53 illustrating the relative size of the insulated and non-insulated regions of the cannula of FIGS. 51-53 ;
- FIG. 54 is a perspective view of an example of a neurophysiology system capable of connecting to the pedicle access systems of FIGS. 1, 19, and 31 to conduct pedicle integrity tests.
- FIG. 1 illustrates an example of a pedicle access system 10 according to one embodiment of the present invention.
- the pedicle access system 10 includes a cannula 12 , a stylet 14 , and a T-handle 16 .
- the pedicle access system 10 may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during formation of the pilot hole.
- the cannula 12 and stylet 14 may be lockingly mated to form a cannula/stylet combination 15 which may be inserted through an operating corridor to the pedicle target site, using the T-handle 16 to facilitate easy movement and positioning of the cannula/stylet combination 15 .
- the cannula/stylet combination 15 may be driven into the bone at the target site to form a pilot hole while a stimulation signal is applied to the pedicle access system 10 and conducted to the target site to assess the integrity of the pedicle during hole formation.
- the T-handle 16 may be detached from the cannula/stylet combination 15 to facilitate the use of various surgical tools (such as by way of example only a forceps, mallet, or needle driver) after proper positioning of the cannula 12 and stylet 14 . Additionally, removal of the T-handle after proper positioning of the cannula/stylet combination 15 provides a less obstructed view of the operating corridor and surgical target site.
- the cannula 12 and stylet 14 are generally cylindrical in shape. However, it should be understood that cannula 12 and stylet 14 may be provided in any suitable shape having any suitable cross-section (e.g. generally oval or polygonal) without deviating from the scope of the present invention.
- FIG. 2 illustrates an example of a cannula 12 forming part of pedicle access system 10 .
- Cannula 12 includes a coupling element 18 and an elongated shaft 20 .
- An interior lumen extends through the cannula 12 from a first opening 22 located at a proximal region 30 of the coupling element 18 to a second opening 24 located at a distal end 21 of the elongated shaft 20 .
- Elongated shaft 20 may be composed of any conductive material such as metal, for example.
- a polymeric coating is provided on a substantial portion of the exterior surface of elongated shaft 20 such that elongated shaft 20 comprises an insulated portion 26 and an uninsulated portion 28 .
- elongated shaft 20 is shown having a single uniform diameter, it will be appreciated that one or more diameter changes may be incorporated along the elongated shaft 20 without deviating from the scope of the present invention.
- coupling element 18 comprises a proximal region 30 , a center section 32 , and a base portion 34 .
- Proximal region 30 is dimensioned to engage with the stylet 14 (described below).
- Proximal region 30 may include at least one tab member 36 that protrudes in a generally lateral direction from the proximal region 30 .
- proximal region 30 includes two tab members 36 positioned opposite one another and adjacent to first opening 22 .
- tab members 36 function to lock the cannula 12 and stylet 14 together.
- Center section 32 is dimensioned to be received within T-handle aperture 66 ( FIG. 16 ) as described in further detail below.
- Center section 32 may be provided with at least one cutout 38 dimensioned to receive a locking mechanism 68 ( FIG. 16 ) incorporated into T-handle 16 to secure the T-handle 16 to the cannula/stylet combination 15 , or optionally to the cannula 12 only.
- the base 34 has a circumference that is greater than the circumference of center section 32 , such that a ledge 39 is formed at the interface of center section 32 and the base portion 34 .
- the ledge 39 engages the rim 72 of T-handle 16 so as to minimize potential stress on a T-handle locking mechanism 68 discussed below.
- FIG. 4 illustrates an example of a stylet 14 forming part of the pedicle access system 10 .
- Stylet 14 includes a locking cap 40 and a needle element 42 .
- Locking cap 40 has a similar size and shape to center section 32 , and is similarly dimensioned to be received within T-handle aperture 66 , discussed below.
- Locking cap 40 includes a distal end 44 and a proximal end 46 .
- locking cap 40 includes a generally cylindrical aperture 48 having an opening at distal end 44 and extending in a proximal direction at least partially the length of locking cap 40 .
- Generally cylindrical aperture 48 is dimensioned to receive the generally cylindrical proximal region 30 of cannula 12 .
- locking cap 40 includes at least one longitudinal channel 50 (defined by an axis extending through the proximal and distal ends 46 , 44 respectively) and at least one lateral channel 52 extending generally perpendicularly from longitudinal channel 50 .
- Longitudinal channel 50 and lateral channel 52 each extend from an exterior surface 54 through an interior surface 56 into aperture 48 .
- the number of longitudinal channels 50 and lateral channels 52 correspond to the number of tab members 36 on cannula 12 .
- cannula 12 includes two tab members 36 and stylet 14 includes two longitudinal channels 50 and two lateral channels 52 .
- Longitudinal channel 50 initiates at the distal end 46 and has a length corresponding to the length of the generally cylindrical 48 .
- Lateral channel 52 initiates at the proximal end of longitudinal channel 50 and extends generally perpendicularly therefrom such that together the longitudinal and lateral channels 50 , 52 form a generally half-T shape.
- Longitudinal channel 50 and lateral channel 52 function to interact with the tab 36 on cannula 12 , so as to lock the stylet 14 and cannula 12 together.
- Longitudinal channel 50 has a width dimension sufficient to accommodate the length of tab member 36 and lateral channel 52 has a height dimension sufficient to accommodate the height of tab member 36 (best viewed in FIG. 12 ).
- a ridge 58 (shown in FIG.
- a portion of exterior surface 54 adjacent to proximal end 46 may comprise a ramped surface 49 such that the circumference of distal end 44 is slightly greater than the circumference of proximal end 46 , so as to facilitate engagement with the T-handle 16 .
- the needle element 42 comprises an elongated shaft 41 having a proximal region 43 and a distal region 45 .
- the proximal region 43 may be attached to the interior of locking cap 40 between proximal end 46 and aperture 48 .
- Elongated shaft 41 extends distally from proximal region 43 with a significant portion protruding generally perpendicularly from the opening of aperture 48 .
- Needle element 42 is dimensioned to be inserted through the interior lumen of cannula 12 .
- the distal region 45 generally includes a distal portion of elongated shaft 41 and a shaped tip 47 having any form or shape capable of being driven into the pedicle to create a pilot hole.
- shaped tip 47 may have a beveled or double diamond form. As illustrated in FIG. 6 , when needle element 42 is fully inserted into cannula 12 , at least a portion of distal region 45 (including shaped tip 47 ) may protrude slightly from the second opening 24 of cannula 12 . Due to the insulated nature of cannula 12 , the portion of needle element 42 that protrudes from cannula 12 effectively constitutes a stimulation region 60 .
- the stimulation region 60 may include the distal region 45 and/or the shaped tip 47 .
- any part of the needle element 42 may be provided with a coating to insulate and therefore limit or reduce the stimulation region 60 to a desired configuration.
- the distal tip 47 may have an insulation coating to effectuate a stimulation region 60 consisting of the portion of the distal region 45 of the needle element 42 between the insulated cannula 12 and the insulated distal tip 47 .
- the entirety of needle element 42 may be provided with an insulative coating and the distal region 21 of cannula 12 may be provided with (for example) one or more uninsulated portions 29 ( FIG.
- Needle element 42 may be composed of a conductive material, such as metal.
- needle element 42 may be composed of a non-conductive material with one or more embedded conductive elements at or near the distal end (e.g. distal region 45 and/or shaped tip 47 ) capable of being communicatively linked with a pedicle integrity testing system.
- FIGS. 9-15 illustrate the formation of the cannula/stylet combination 15 .
- stylet 14 is introduced into cannula 12 .
- Needle element 42 of stylet 14 is inserted into the interior lumen of cannula 12 through the first opening 22 of coupling element 18 .
- the locking cap 40 of stylet 14 is positioned such that its longitudinal channels 50 are aligned with the tab members 36 of cannula 12 .
- the proximal region 30 of cannula 12 is received into the aperture 48 of locking cap 40 , and the tab members 36 pass through the longitudinal channels 50 as insertion of needle element 42 progresses.
- Insertion is complete when the proximal portion 30 is fully received by aperture 48 , leaving the locking cap 40 in the “unlocked” position illustrated in FIGS. 11-13 .
- the distal region 45 of needle element 42 including shaped tip 47 (and the stimulation region 60 ) may protrude from the second opening 24 of the elongated shaft 20 of cannula 12 when stylet 14 is fully inserted, shown in FIG. 11 .
- tab members 36 are positioned at the proximal end of longitudinal channels 50 where the channels intersect lateral channels 52 .
- the corresponding shapes of the locking cap 40 of stylet 14 and center section 32 of cannula 12 are out of alignment.
- the locking cap 40 is rotated until it is aligned with the center section 32 as illustrated in FIGS. 14-15 .
- ridges 58 come into contact with the tab members 36 .
- the ridges may not pass the tab members 36 if the locking cap 40 is not rotated with enough force to deform the ridges 58 .
- the rotation may continue towards the final position.
- the locking cap 40 and center section 32 become aligned and the ridges 58 may clear the tab members 36 and regain their original forms, thereby preventing inadvertent rotation of the locking cap 40 back to the unlocked position.
- FIG. 16 illustrates an example of a T-handle 16 forming part of the pedicle access system 10 .
- T-handle 16 includes a grip region 64 , an aperture 66 for engaging the cannula 12 or cannula/stylet combination 15 , and a locking mechanism 68 for securing the T-handle to the cannula 12 .
- Grip region 64 may be provided in any number of suitable shapes and sizes that may aid the user in holding and manipulating the pedicle access system 10 during use.
- the T-handle aperture 66 is dimensioned to snugly receive both the locking cap 40 and center section 32 when they are aligned in the locked position as described above.
- the locking mechanism 68 preferably comprises a lever having one end that is integrated into the aperture wall and a free end 70 extending therefrom.
- the majority of the locking mechanism 68 (excluding free end 70 ) may comprise the same thickness as the aperture wall and does not protrude, interiorly or exteriorly, from the aperture wall.
- the interior surface of free end 70 protrudes into the aperture 66 space.
- the interior surface of free end 70 is dimensioned to engage the cutout 38 in the center section 32 of cannula 12 .
- the interior surface of free end 70 may be slightly ramped, such that the edge further from the aperture opening protrudes further into the aperture than the edge closer to the aperture opening.
- the ramped portion works in concert with the ramped surface 49 at the proximal end 46 of locking cap 40 to force the free end 70 out of its natural state as the locking cap 40 of stylet 14 and center section 32 of cannula 12 are received into the T-handle aperture 66 .
- the interior surface of free end 70 aligns with the cutout 38 in the center section 32 and free end 70 returns to its natural state, thus locking the T-handle 16 to the cannula 12 .
- the ledge 39 engages the rim 72 .
- T-handle 16 This interaction functions to minimize potential stress on the T-handle locking mechanism 68 by increasing the surface area that receives force applied by the user.
- the free end 70 may be lifted to disengage with the cutout 38 , and the T-handle may be pulled off.
- T-handle 16 may be cannulated (not shown) such that an interior lumen extends from an opening on the top of the handle into the aperture 66 .
- FIGS. 19-20 illustrate an example of a pedicle access system 110 according to an alternative embodiment of the present invention.
- the pedicle access system 110 includes a cannula 112 , a stylet 114 , and a lock collar 116 .
- pedicle access system 110 may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during formation of the pilot hole.
- the cannula 112 and stylet 114 may be lockingly mated and inserted through an operating corridor to the pedicle target site, using the handle portion 140 of the stylet 114 to facilitate easy movement and positioning of pedicle access system 110 .
- the pedicle access system 110 may be driven into the bone at the target site to form a pilot hole while a stimulation signal is applied and conducted to the target site to assess the integrity of the pedicle during hole formation.
- the cannula 112 and stylet 114 are generally cylindrical in shape. However, it should be understood that cannula 112 and stylet 114 may be provided in any suitable shape having any suitable cross-section (e.g. generally oval or polygonal) without deviating from the scope of the present invention.
- FIGS. 21-22 illustrate an example of a cannula 112 forming part of pedicle access system 110 .
- Cannula 112 includes a coupling element 118 and an elongated shaft 120 .
- An interior lumen extends through the cannula 112 from a first opening 122 located at a proximal region 130 of the coupling element 118 to a second opening 124 located at a distal end 121 of the elongated shaft 120 .
- Elongated shaft 120 may be composed of any conductive material such as metal, for example.
- a polymeric coating may be provided on a substantial portion of the exterior surface of elongated shaft 120 such that elongated shaft 120 comprises an insulated portion 126 and an uninsulated portion 128 (the edge of the coating and thus the boundary between portions 126 , 128 represented by callout 127 in FIGS. 21-22 ).
- Elongated shaft 120 may include any number of diameter changes incorporated along its length without deviating from the scope of the present invention. In the alternative, elongated shaft 120 may be provided with a uniform diameter along its length.
- coupling element 118 comprises a proximal region 130 , a center section 132 , and a distal portion 134 .
- Proximal region 130 includes an engagement region 131 dimensioned to engage with the handle portion 140 of the stylet 114 (as described in further detail below).
- the engagement region 121 may be provided in any suitable geometric configuration to allow for secure mating with the engagement tabs 144 of the handle 140 .
- the coupling element 118 is shown in FIGS. 23-24 having a hexagonal engagement region 131 , however other shapes are possible.
- Proximal region 130 may include at least one tab member 136 that protrudes in a generally lateral direction from the proximal region 130 .
- proximal region 130 includes two tab members 136 positioned opposite one another and adjacent to first opening 122 .
- Tab members 136 may be utilized to attach supplemental instruments and/or apparatuses to the cannula 112 .
- Center section 132 may be provided with a diameter that is larger than the diameters of the proximal region 130 and distal portion 134 , and may be provided with a plurality of ridges 133 and/or other features for the purpose of providing a suitable gripping area for a user.
- the distal portion 134 is dimensioned to engage with the elongated shaft 120 of the cannula 112 .
- FIG. 25 illustrates an example of a stylet 114 forming part of the pedicle access system 110 .
- Stylet 114 includes a handle portion 140 and a needle element 142 .
- Handle portion 140 may (by way of example) resemble a T-handle for providing a user with a suitable gripping means.
- Handle portion 140 may be provided with a pair of engagement tabs 144 extending distally from handle portion 140 .
- Engagement tabs 144 extend generally perpendicularly from the handle 140 and generally parallel to one another such that the engagement tabs 144 collectively form an interior space 146 .
- Interior space 146 is dimensioned to receive the proximal region 130 of the coupling element 118 of the cannula 112 .
- Each engagement tab 144 is provided with a medial (inwardly-facing) indentation 148 and a lateral (outwardly-facing) indentation 150 .
- Medial indentations 148 are dimensioned to engage the engagement region 131 of the coupling element 118 , described above.
- the medial indentations 148 may be provided with any geometry complementary to the shape of the engagement region 131 such that when mated, the engagement tabs 144 (via the medial indentations 148 ) will prevent movement of the engagement region 131 , in effect locking the cannula 112 in place relative to the stylet 114 .
- the lateral indentations 150 are dimensioned to interact with the first and second protrusions 170 , 172 of the lock collar 116 described in further detail below.
- the needle element 142 comprises an elongated shaft 152 having a proximal region 154 and a distal region 156 .
- the proximal region 154 may be attached to the interior of handle portion 140 .
- Elongated shaft 152 extends distally from proximal region 154 and generally perpendicularly from the handle 140 .
- Needle element 142 is dimensioned to be inserted through the interior lumen of cannula 112 .
- the distal region 156 generally includes a distal portion of elongated shaft 152 and a shaped tip 158 having any form or shape capable of being driven into the pedicle to create a pilot hole.
- shaped tip 158 may have a beveled or double diamond form. As illustrated in FIG.
- distal region 156 when needle element 142 is fully inserted into cannula 112 , at least a portion of distal region 156 (including shaped tip 158 ) may protrude slightly from the second opening 124 of cannula 112 . Due to the insulated nature of cannula 112 , the portion of needle element 142 that protrudes from cannula 112 effectively constitutes a stimulation region 160 .
- the stimulation region 160 may include the distal region 152 and/or the shaped tip 158 .
- any part of the needle element 142 may be provided with a coating to insulate and therefore limit or reduce the stimulation region 160 to a desired configuration.
- the distal tip 158 may have an insulation coating to effectuate a stimulation region 160 consisting of the portion of the distal region 156 of the needle element 142 between the insulated cannula 112 and the insulated distal tip 158 .
- This coating serves to mitigate an apparent phenomenon in which certain geometries (e.g. points and edges) tend to generate significantly higher current densities and therefore are much more efficient at exciting a nearby nerve, even through bone tissue.
- instrumentation having these geometries may show a lower stimulation threshold (and thus causing an EMG monitoring system to indicate a breach in an intact pedicle) unless this phenomenon is otherwise compensated for.
- Needle element 142 may be composed of any conductive material, such as metal.
- needle element 142 may be composed of a non-conductive material with one or more embedded conductive elements at or near the distal end (e.g. distal region 156 and/or shaped tip 158 ) capable of being communicatively linked with a pedicle integrity testing system.
- Lock collar 116 is provided to lockingly mate the cannula 112 and the stylet 114 .
- Lock collar 116 has a generally cylindrical overall shape, and includes a proximal portion 162 , a distal portion 164 and an interior lumen 166 extending therethrough.
- the proximal portion 162 may have a diameter greater than that of the distal portion 164 and is provided with a plurality of friction elements 168 to allow a user to grasp and turn the lock collar 116 .
- the distal portion 164 includes a generally oval-shaped opening 170 providing access to the lumen 166 .
- the opening 170 further includes a pair of opposing first protrusions 172 and a pair of opposing second protrusions 174 located along the inside edge of opening 170 .
- First protrusions 172 are located 180° from one another and are positioned at the long ends of the oval-shaped opening 170 .
- Second protrusions 174 are positioned at the narrow sides of the oval-shaped opening 170 (and thus are located at 90° intervals from the first protrusions 172 and 180° from one another).
- First and second protrusions 172 , 174 are each dimensioned to engage the lateral indentations 150 provided on the engagement tabs 144 of the handle 140 , described above.
- the interior lumen 166 is dimensioned to receive both of the engagement tabs 144 of the handle 140 .
- the pedicle access system 110 of the present invention may be provided with the locking collar 116 attached to the stylet 114 in an initial position. This initial position is defined by the first protrusions 172 resting in the lateral indentations 150 of the engagement tabs 144 of the handle 140 .
- the distal region 130 of the coupling element 118 of cannula 112 will enter the space 146 of the handle 140 such that the medial indentations 148 are aligned with (but not yet engaging) the engagement region 131 of the coupling element 118 .
- FIGS. 31-34 illustrate an example of a pedicle access system 210 according to a further alternative embodiment of the present invention.
- the pedicle access system 210 includes a cannula 212 , a stylet 214 , a lock collar 216 and a retractable insulation sheath 217 .
- pedicle access system 210 may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during formation of the pilot hole.
- the cannula 212 and stylet 214 may be lockingly mated and inserted through an operating corridor to the pedicle target site, using the handle portion 240 of the stylet 214 to facilitate easy movement and positioning of pedicle access system 210 .
- the pedicle access system 210 may be driven into the bone at the target site to form a pilot hole while a stimulation signal is applied and conducted to the target site to assess the integrity of the pedicle during pilot hole formation.
- the retractable insulation sheath 217 functions to ensure maximum efficiency of the stimulation signal as by limiting or preventing shunting of the signal during pilot hole formation.
- the cannula 212 , stylet 214 and retractable insulation sheath 217 are generally cylindrical in shape. However, it should be understood that cannula 212 , stylet 214 and sheath 217 may be provided in any suitable shape having any suitable cross-section (e.g. generally oval or polygonal) without deviating from the scope of the present invention.
- the retractable insulation sheath 217 functions to ensure maximum efficiency of the stimulation signal as by limiting or preventing shunting of the signal during pilot hole formation. With specific reference to FIGS. 32-34 , this is accomplished by providing a tubular insulation member 274 slideably mated with a housing member 276 described in greater detail below. In an initial position (shown in FIGS. 33-34 ), the tubular insulation member 274 is fully extended such that it extends at least to the tip 258 of the stylet 214 . Upon formation of a pilot hole in a pedicle (or other piece of bone), the stylet 214 will advance into the bone while the insulation sheath remains outside the bone (a position shown by way of example in FIG. 32 ).
- the electrical current when supplied will be directed into the pilot hole by the uninsulated portion of the cannula 212 and stylet 214 while prevented from shunting outside of the hole by the sheath 217 .
- FIGS. 35-36 illustrate an example of a cannula 212 forming part of pedicle access system 210 of the present invention.
- Cannula 212 includes a coupling element 218 and an elongated shaft 220 .
- An interior lumen extends through the cannula 212 from a first opening 222 located at a proximal region 230 of the coupling element 218 to a second opening 224 located at a distal end 221 of the elongated shaft 220 .
- Elongated shaft 220 may be composed of any conductive material such as metal, for example.
- Elongated shaft 220 may include any number of diameter changes incorporated along its length without deviating from the scope of the present invention. In the alternative, elongated shaft 220 may be provided with a uniform diameter along its length.
- coupling element 218 comprises a proximal region 230 , a center section 232 , and a distal portion 234 .
- Proximal region 230 includes an engagement region 231 dimensioned to engage with the handle portion 240 of the stylet 214 (as described in further detail below).
- the engagement region 231 may be provided in any suitable geometric configuration to allow for secure mating with the engagement tabs 144 of the handle 140 .
- the coupling element 218 is shown in FIGS. 37-38 having a plurality of triangular-shaped indentations 233 , however other shapes are possible.
- Proximal region 230 may include at least one tab member 236 that protrudes in a generally lateral direction from the proximal region 230 .
- proximal region 230 includes two tab members 236 positioned opposite one another and adjacent to first opening 222 .
- Tab members 236 may be utilized to attach supplemental instruments and/or apparatuses to the cannula 212 .
- Center section 232 may be provided with a diameter that is larger than the diameters of the proximal region 230 and distal portion 234 , and may be provided with a plurality of ridges 235 and/or other features for the purpose of providing a suitable gripping area for a user.
- the distal portion 234 is dimensioned to engage with the elongated shaft 220 of the cannula 212 and may further be provided with a recess 237 for engagement with the sheath attachment element 292 , described in further detail below.
- FIG. 39 illustrates an example of a stylet 214 forming part of the pedicle access system 210 .
- Stylet 214 includes a handle portion 240 and a needle element 242 .
- the handle portion 240 may (by way of example) resemble a T-handle for providing a user with a suitable gripping means.
- the handle portion 240 may have a substantially hollow interior that is not fully enclosed.
- Handle portion 240 includes an aperture 243 and a pair of engagement tabs 244 extending distally from handle portion 240 .
- Aperture 243 is dimensioned to allow passage of the needle element 242 from the handle portion 240 .
- Engagement tabs 244 extend generally perpendicularly from the handle 240 and generally parallel to one another such that the engagement tabs 244 collectively form an interior space 246 .
- Interior space 246 is dimensioned to receive the proximal region 1230 of the coupling element 218 of the cannula 212 .
- Each engagement tab 244 is provided with a medial (inwardly-facing) protrusion 248 .
- Medial protrusions 248 are dimensioned to engage the engagement region 231 of the coupling element 218 , described above.
- the medial protrusions 248 may be provided with any geometry complementary to the shape of the engagement region 231 such that when mated, the engagement tabs 244 (via the medial protrusions 248 ) will prevent movement of the engagement region 231 , in effect locking the cannula 212 in place relative to the stylet 214 .
- the needle element 242 comprises an elongated shaft 252 having a proximal region 254 and a distal region 256 .
- the proximal region 254 includes an attachment element 257 configured to attach to the interior of handle portion 240 .
- the attachment element 257 is also configured to provide a point of contact for an electrical stimulation source (e.g. a clip attached to an electrical source).
- Elongated shaft 252 extends distally from proximal region 254 and generally perpendicularly from the handle 240 (and through aperture 243 ). Needle element 242 is dimensioned to be inserted through the interior lumen of cannula 212 .
- the distal region 256 generally includes a distal portion of elongated shaft 252 and a shaped tip 258 having any form or shape capable of being driven into the pedicle to create a pilot hole.
- shaped tip 258 may have a beveled or double diamond form.
- Needle element 242 may be composed of any conductive material, such as metal.
- needle element 242 may be composed of a non-conductive material with one or more embedded conductive elements at or near the distal end (e.g. distal region 256 and/or shaped tip 258 ) capable of being communicatively linked with a pedicle integrity testing system.
- the stylet 214 is preferably provided as a single unit, with the needle element 242 and attachment element 257 molded in place in the handle 240 .
- Lock collar 216 is provided to lockingly mate the cannula 212 and the stylet 214 .
- Lock collar 216 has a generally cylindrical overall shape, and includes a proximal portion 262 , a distal portion 264 and an interior lumen 266 extending therethrough.
- the proximal portion 262 may have a diameter greater than that of the distal portion 264 and is provided with a plurality of friction elements 268 to allow a user to grasp and turn the lock collar 216 .
- the distal portion 264 includes a generally oval-shaped opening 270 providing access to the lumen 266 .
- the opening 270 further includes a pair of opposing protrusions 272 located along the inside edge of opening 270 .
- Protrusions 272 are located 180° from one another and are positioned approximately midway between the “long ends” and the “narrow sides” of the oval-shaped opening 270 . Protrusions 272 are dimensioned to engage the sides of engagement tabs 244 of the handle 240 , described above.
- the interior lumen 266 is dimensioned to receive both of the engagement tabs 244 of the handle 240 .
- the pedicle access system 210 of the present invention may be provided with the locking collar 216 attached to the stylet 214 in an initial position. This initial position is defined by the protrusions 272 resting alongside the engagement tabs 244 of the handle 240 .
- the engagement tabs 244 at this point are disposed in the “long ends” of the oval-shaped opening 270 .
- the distal region 230 of the coupling element 218 of cannula 212 will enter the space 246 of the handle 240 such that the medial protrusions 248 are aligned with (but not yet engaging) the engagement region 231 of the coupling element 218 .
- a user would then rotate the lock collar 216 90° to a second position such that the protrusions 272 rest in against the engagement tabs 244 and the engagement tabs 244 rest in the “narrow sides” of the oval-shaped opening 270 , as shown in FIG. 45 .
- the engagement tabs 244 will be forced toward one another, and the medial protrusions 248 will come in contact with and positively engage the engagement region 231 . As noted previously, this positive engagement prevents the cannula 212 from moving.
- the lock collar 216 serves to lock the engagement tabs 214 in place, effectively locking the cannula 212 and the stylet 214 together.
- the pedicle access system 210 is now ready for use.
- the pedicle access system 210 may be provided with a retractable insulation sheath 217 to electrically insulate the cannula 212 and stylet 214 .
- the insulation sheath 217 may be composed of a non-conductive material or coated with a non-conductive polymer coating to insulate the sheath 217 . This prevents shunting of electrical current during pilot hole formation, increasing the efficiency with which the stimulation current is delivered to the target area.
- the insulation sheath 217 includes an insulation tube 274 and a housing member 276 . As seen in FIG.
- the insulation tube comprises a cannulated, elongated and generally cylindrical member having a proximal end 278 and a distal end 280 .
- the proximal end 278 includes at least one tab 282 configured to slideably engage the housing member 276 as set forth below.
- the insulation tube 274 includes a pair of tabs 282 positioned opposite one another, however any number of tabs 282 may be provided without departing from the scope of the invention.
- the distal end 280 may be provided with a generally tapered surface 284 to allow for an improved interface with the bone.
- the housing member 276 comprises an elongated generally cylindrical member having a proximal end 286 , a distal end 287 and an interior lumen 288 .
- the proximal end 286 includes a shaped engagement feature 289 (e.g. a recess as shown) dimensioned to engage a sheath attachment element 292 described in further detail below.
- the housing member 276 further includes at least one elongated track 290 in the form of a cutout section extending substantially the length of the housing member 276 .
- the track 290 is dimensioned to slideably receive the tabs 282 of the insulation tube 274 such that the insulation tube 274 is allowed to migrate within the lumen 288 .
- the sheath attachment element 292 may be provided as a generally cylindrical member having an interior lumen 293 .
- Sheath attachment element 292 is dimensioned to provide a snap-fit engagement with both the housing member 276 and the coupling element 218 of cannula 212 .
- the lumen 293 is provided with a first ridge 294 near a distal end for secure engagement with recess 289 of the housing member 276 .
- the lumen 293 is provided with a second ridge (not shown) near a proximal end for engagement with recess 237 of the coupling element 218 ( FIG. 37 ).
- the retractable insulation sheath 217 may be provided with the sheath attachment element 292 mated to the housing member 276 .
- the cannula 212 is then inserted into the insulation sheath 217 and sheath attachment element 292 will then engage the coupling element 218 , thus securely attaching the insulation sheath 217 to the pedicle access system 210 .
- the pedicle access system 210 is provided with the insulation tube 274 in a first, fully extended position (e.g. FIG. 33 ).
- the insulation tube 274 will remain in this position as the pedicle access system 210 is advanced through an operative corridor to a bony target site (e.g. a pedicle).
- a bony target site e.g. a pedicle.
- the tip 258 of the needle element 242 and the distal end 280 of the insulation tube 274 may contact the bone at approximately the same time.
- the user may want to begin monitoring the integrity of the pilot hole formation by using a stimulation signal as described below.
- the distal end 280 remains engaged to the outside surface of the bone.
- the proximal end 278 (including tabs 282 ) of the insulation tube will advance proximally along the track 290 of the housing member 276 .
- the portion of needle element 242 and cannula 212 that protrude from insulation tube 274 effectively constitute a stimulation region 260 ( FIG. 32 ).
- the stimulation region 260 becomes larger.
- the needle 242 and cannula 212 are withdrawn from the bony structure, and the pedicle access system 210 may be removed from the operative corridor.
- a spring (not shown) or other control mechanism may be provided to limit the extent of migration of the insulation tube 274 and/or provide a means for the insulation tube 274 to bias toward returning to the fully extended position upon removal of the needle 242 from the pilot hole in the pedicle.
- the pedicle access systems 10 , 110 and 210 described above may be used in combination with neurophysiology monitoring systems and methods to conduct pedicle integrity assessments while achieving initial access to the pedicle.
- the pedicle access systems 10 , 110 and 210 may be used in combination with the system and methods shown and described in commonly owned and co-pending Int'l Patent App. Ser. No. PCT/US02/22247, filed on Jul. 11, 2002, the contents of which are hereby incorporated by reference into this disclosure as set forth herein in its entirety.
- an example of one such neurophysiology system 300 includes a display 301 , a control unit 302 , a patient module 304 , an EMG harness 306 , including eight pairs of EMG electrodes 308 and a return electrode 310 coupled to the patient module 304 , and a host of surgical accessories 312 , including an electric coupling device 316 capable of being coupled to the patient module 304 via one or more accessory cables 314 .
- the neurophysiology system 300 performs pedicle integrity assessments by determining the amount of electrical communication between a stimulation signal and the adjacent nerve root. To do this, a stimulation signal is applied to the pilot hole or pedicle screw via one of the surgical accessories 312 .
- the EMG electrodes 308 positioned over the appropriate muscles, measure the EMG responses corresponding to the stimulation signal. The relationship between the EMG response and the stimulation signal is then analyzed by the system and the results are conveyed to the user on the display 301 .
- the basic theory underlying the pedicle integrity test is that given the insulating character of bone, a higher stimulation current (or current density) is required to evoke an EMG response when the stimulation signal is applied to an intact pedicle as opposed to a breached pedicle.
- the neurophysiology system may be provided with software capable of compensating for multiple safe stimulation thresholds based on different current densities being applied to the pedicle by certain geometries of different instruments.
- the pedicle access systems 10 , 110 and 210 described above may be combined to and used in conjunction with the neurophysiology system 300 by attaching (not shown) the electric coupling device 314 to (for example) the uninsulated region 28 of the cannula 12 of pedicle access system 10 .
- the electric coupling device 314 may comprise a number of possible embodiments which permit the device to attach and hold a surgical tool (such as the pedicle access system 10 ) while allowing transmission of a stimulation signal to the tool.
- One such electric coupling device 314 utilizes a spring-loaded plunger to hold the surgical tool and transmit the stimulation signal.
- the plunger 318 is composed of a conductive material such as metal.
- a nonconductive housing 320 partially encases the plunger rod 318 about its center.
- Extending from the housing 320 is an end plate 324 .
- An electrical cable 326 connects the electric coupling device 314 to neurophysiology system 300 .
- a spring (not shown) is disposed within the housing 320 such that in a natural or “closed” state the plunger 318 is situated in close proximity to the endplate 324 . Exerting a compressive force on the spring (such as by pulling the cable 326 while holding the housing 320 ) causes a gap between the end plate 324 and the plunger 318 to widen to an “open” position, thereby allowing insertion of a surgical tool between the end plate 324 and plunger 318 .
- Releasing the cable 326 allows the spring to return to a “closed” position, causing the plunger 318 to move laterally back towards the endplate such that a force is exerted upon the surgical tool and thereby holds it in place between the endplate 324 and the plunger 318 . Thereafter the electrical stimulus may be passed from the neurophysiology system 300 through the cable 326 and plunger 318 to the surgical tool.
- the electrical coupling device may be embodied in the form of a clip 328 .
- the clip 328 is comprised of two prongs hingedly coupled at a coupling point 330 such that the clip 328 includes an attachment end 332 and a non-attachment end 334 .
- a stimulation electrode 336 is disposed on the attachment end 332 and communicates with an electric cable 326 extending from the non-attachment end 334 to the neurophysiology system 300 .
- the prong ends at the attachment end 332 touch. Depressing the prongs at the non-attachment end 334 in a direction towards each other causes a gap to form between the prong ends at the attachment end 332 .
- the pedicle access system 10 may thus be used to safely access the pedicle and safely form a pilot hole.
- the cannula 12 , stylet 14 , and T-handle 16 are preferably all combined and locked together as described above.
- the surgeon may position the stimulation point on the desired target site.
- the electric coupling device 116 may be attached to the uninsulated region 28 of cannula 12 and the T-handle 16 may be removed to facilitate the use of a tool such as a needle driver.
- Stimulation signals are delivered to the pedicle access system 10 and emitted from the stimulation region 60 as it is being driven in to the bone, forming the pilot hole.
- pilot hole formation may be halted and any steps deemed to be necessary by the surgeon, based on his or her professional judgment, may be taken to correct the problem.
- the electric coupling device 316 may be attached before positioning the pedicle access system 10 , and the neurophysiology system 300 may be employed to monitor the proximity of any nerves during positioning.
- the pedicle access system 10 may be used in conjunction with spinal fixation systems that require access to pedicle target sites and need pilot holes, including but not limited to those systems shown and described in commonly owned and co-pending U.S. patent application Ser. No. 11/031,506 filed Jan. 6, 2005, and commonly owned and co-pending Int'l Patent App. Ser. No. PCT/US05/032300 filed Sep. 8, 2005.
- the T-handle 16 and stylet 14 may be unlocked and removed from the cannula 12 , leaving the cannula 12 positioned in the pilot hole.
- Guide wires subsequently used by the spinal fixation systems may then be safely deployed to the pilot hole through the cannula 12 . Once the guide wire is in position the cannula 12 may be removed from the target site and the surgeon may commence use of the surgical fixation system.
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Abstract
A pedicle access system including a cannula, a stylet, and a removable T-handle. The pedicle access system may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during the pilot hole formation. To do this, the cannula and stylet are locked in combination and inserted through an operating corridor to the pedicle target site, using the T-handle to facilitate easy movement and positioning of the cannula/stylet combination. A stimulation signal may be applied during pilot hole formation to conduct the pedicle integrity assessment. In a significant aspect, the T-handle may be detached from the cannula/stylet combination to facilitate the use of various surgical tools as necessary.
Description
- The present application is a continuation of U.S. patent application Ser. No. 15/786,760, filed Oct. 18, 2017, which is a continuation of U.S. patent application Ser. No. 14/338,154, filed Jul. 22, 2014, which is a continuation of U.S. patent application Ser. No. 13/109,981, filed May 17, 2011, now issued as U.S. Pat. No. 8,784,330 (the contents being incorporated herein by reference), which is a continuation of U.S. patent application Ser. No. 11/448,237, filed Jun. 6, 2006, now issued as U.S. Pat. No. 7,942,826 (the contents being incorporated by reference), which claims priority from U.S. Provisional Patent Application No. 60/687,947, filed Jun. 6, 2005 (the contents being incorporated herein by reference).
- The present invention relates to a system and methods aimed at accessing a pedicle in preparation for the placement of pedicle screws.
- An emerging trend in spinal surgery is to perform surgery in a minimally invasive or minimal access fashion to avoid the trauma of so-called open or “direct access” procedures. A specific area of interest is in the placement of pedicle screws, which are typically employed to effect posterior fixation in spinal fusion procedures. While great strides are being made in this area, a risk exists (as it does in open procedures) that the pedicle may become breached, cracked, or otherwise compromised during the procedure. If the pedicle (or more specifically, the cortex of the medial wall, lateral wall, superior wall and/or inferior wall) is breached, cracked, or otherwise compromised, the patient may experience pain or neurologic deficit due to unwanted contact between the pedicle screw and exiting nerve roots. This often necessitates revision surgery, which can be painful and costly, both in terms of recovery time and hospitalization.
- Some attempts to minimize the risk of a pedicle breach involve capitalizing on the insulating characteristics of bone and the conductivity of the exiting nerve roots themselves to perform pedicle integrity assessments. That is, if the wall of the pedicle is breached, a stimulation signal applied to the pedicle screw and/or the pilot hole (prior to screw introduction) will cause the various muscle groups coupled to the exiting nerve roots to contract. If the pedicle wall has not been breached, the insulating nature of the pedicle will prevent the stimulation signal from innervating the given nerve roots such that the associated muscle groups will not twitch. Traditional EMG monitoring systems may be employed to augment the ability to detect such innervation.
- One period during a pedicle screw procedure in which the risk of a pedicle breach is prevalent is during the initial access of the pedicle. Typically, initial access to a pedicle may be achieved by inserting a needle to the target site and driving the needle point into the pedicle, creating a pilot hole. Due to the size and shape of the typical needle, however, manipulation and maneuvering of the needle may be awkward or difficult, increasing the risk of complication. Additionally, the pedicle may be breached and nerve damage done during the initial drive of the needle into the pedicle, before a pedicle integrity test assessment may be performed.
- A problem that may arise when various medical instruments are electrified and used with traditional EMG monitoring systems is that different instruments may produce different EMG stimulation thresholds. For example, an electrified needle may exhibit a threshold stimulation of approximately 5-6 mA, while a bone screw placed in the same location may exhibit a threshold stimulation of approximately 16-20 mA. This can be problematic in that an electrified needle may tend to indicate a breach in the pedicle wall when in fact the pedicle wall is intact.
- The present invention is directed at eliminating, or at least improving upon, the shortcomings of the prior art.
- The present invention provides a pedicle access system that facilitates ease of handling and can achieve dynamic pedicle integrity testing while forming a pilot hole.
- According to a broad aspect of the present invention the pedicle access system includes a cannula, a stylet, and a removable T-handle. The pedicle access system of the present invention may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during the pilot hole formation. To do this, the cannula and stylet are locked in combination and inserted through an operating corridor to the pedicle target site, using the T-handle to facilitate easy movement and positioning of the cannula/stylet combination. A stimulation signal may be applied during pilot hole formation to conduct the pedicle integrity assessment. In a significant aspect of the present invention, the T-handle may be detached from the cannula/stylet combination to facilitate the use of various surgical tools as necessary.
- The cannula includes a coupling element and an elongated shaft. An interior lumen extends through the cannula from a first opening in the coupling element to a second opening in the distal region of the elongated shaft. The elongated shaft may be composed of a conductive material, such as metal. A polymeric coating blankets or otherwise encapsulates a majority of the exterior surface of the elongated shaft, such that the elongated shaft includes an insulated region and an uninsulated region. The elongated shaft may incorporate one or more diameter changes along its length.
- The coupling element comprises three sections. First, a proximal region is dimensioned to engage with the stylet. The proximal region may also include at least one tab member protruding in a generally lateral direction. The tab member functions to lock the cannula and stylet in position together. Second, a center section is dimensioned to engage with the T-handle. At least one cutout may be provided in the exterior surface of the center section. The cutout functions to secure the T-handle to the cannula/stylet combination, or optionally to the cannula only. Finally, there is a base portion having a circumference greater than that of the center section such that a ledge is formed at the interface of the center section and the base portion.
- The stylet comprises a locking cap and a needle element. The locking cap has a similar size and shape as the center section. The locking cap contains a generally cylindrical aperture dimensioned to receive the generally cylindrical top section of the cannula. Furthermore, the locking cap includes at least one longitudinal channel and at least one lateral channel that interact with the tab member as a means to secure the stylet and cannula in place.
- The longitudinal channel has a length dimension corresponding to the length of the generally cylindrical aperture and a width dimension sufficient to accommodate the length of the tab member. The lateral channel extends generally perpendicularly from the proximal end of the longitudinal channel, such that together the channels form a generally half-T shape. The longitudinal channel and the lateral channel, along with a ridge positioned on at least one edge of the lateral channel interact with the tab member on the cannula to lock the stylet and cannula together. Additionally, the locking cap may include a ramped surface to facilitate engagement with the T-handle.
- The proximal portion of the needle element may be attached to the interior of the locking cap. The elongated shaft of the needle element extends distally from the proximal portion, with a significant portion protruding from the opening of the generally cylindrical aperture. The needle element is dimensioned to be inserted through the interior lumen of the cannula. When fully inserted, a distal portion of the needle element may protrude slightly from the bottom opening of the cannula. The needle element may be composed of a conductive material, such as metal, or a non-conductive material with one or more embedded conductive elements at or near the distal end capable of being communicatively linked with a pedicle integrity testing system.
- To combine the cannula and stylet, the needle element is inserted into the interior lumen of the cannula through the opening in the coupling element. The locking cap is positioned such that its longitudinal channels are aligned with the tab members of the cannula. The proximal region of the cannula is received into the aperture on the locking cap, and the tab members pass through the longitudinal channels. Insertion is complete when the proximal region is fully received by the aperture, leaving the locking cap in an “unlocked” position. In the unlocked position, the tab members are positioned at the proximal ends of the longitudinal channels. In this position the locking cap and center section of the cannula are not aligned. To lock the stylet in place in the cannula, the locking cap is rotated until it is aligned with the center section. As the lateral channels rotate around the tab members, the ridges may be deformed when they contact the tab members. When the locking cap and center section align, the ridges may clear the tab members and regain their original forms, thereby preventing inadvertent rotation back to the unlocked position.
- The T-handle includes a grip region, an aperture for engaging the cannula or cannula/stylet combination, and a locking mechanism for securing the T-handle to the cannula. The T-handle aperture is dimensioned to snugly receive both the locking cap and the center section of the cannula when they are aligned in the locked position. The locking mechanism preferably comprises a lever having one end integrated into the aperture wall and a free end extending therefrom. The majority of the lever (excluding the free end) may be the same thickness as the aperture wall and does not protrude, interiorly or exteriorly, from the aperture wall. In its “natural” state, the free end does protrude into the aperture space. The free end is dimensioned to engage the cutout in the center section of the cannula. The interior surface of the free end may be slightly ramped. The ramped portion works in concert with the ramped surface of the locking cap to force the free end out of its natural state so the locking cap and the center section can fit into the T-handle aperture. When the locking cap and center section are fully inserted into the T-handle aperture, the locking mechanism aligns with the cutout in the cannula, returns to its natural state, and locks the T-handle to the cannula. Optionally, the T-handle may be cannulated.
- In an alternative aspect of the present invention, the pedicle access system may be provided with a stylet, a cannula and a lock collar. Any part of the stylet and/or cannula may be coated with a nonconductive insulative coating to prevent shunting of electrical current.
- In a further alternative aspect of the present invention, the pedicle access system may be provided with a retractable insulation sheath dimensioned to cover the electrically conductive cannula and stylet needle. The retractable insulation sheath is adapted to electrically insulate the pedicle access system as it is advanced along an operative corridor to a bony structure. As the needle element is introduced into the bony structure (e.g. a pedicle) during pilot hole formation, the insulation sheath retracts to remain outside the bone and prevent electrical current intended for the pilot hole from shunting to surrounding tissue.
- In a significant aspect of the present invention, the pedicle access system may be used in combination with neurophysiology monitoring systems and methods to conduct pedicle integrity assessments while achieving initial access to the pedicle and forming a pilot hole. The neurophysiology system performs pedicle integrity assessments by determining the amount of electrical communication between a stimulation signal and the adjacent nerve root. The pedicle access system may be coupled with the neurophysiology system by attaching an electric coupling device to the uninsulated region of the cannula.
- In another significant aspect of the present invention, the pedicle access system may be used in cooperation with spinal fixation systems that require access to pedicle target sites and need pilot holes, as the cannula may be used to guide parts of the surgical fixation system to the target site.
- 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:
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FIG. 1 is a plan view of an example of a pedicle access system according to one embodiment of the present invention; -
FIG. 2 is a perspective view of a cannula forming part of the pedicle access system ofFIG. 1 ; -
FIG. 3 is a perspective view of a coupling element forming part of the cannula ofFIG. 2 ; -
FIG. 4 is a perspective view of a stylet forming part of the pedicle access system ofFIG. 1 ; -
FIG. 5 is a perspective view of a locking cap forming part of the stylet ofFIG. 4 ; -
FIG. 6 is a perspective view of the distal portion of the stylet ofFIG. 4 protruding from the distal region of the cannula ofFIG. 2 ; -
FIG. 7 is a perspective view of the distal portion of the stylet ofFIG. 4 protruding from the distal region of the cannula ofFIG. 2 , with the distal region of the cannula having an uninsulated portion; -
FIG. 8 is a perspective view of the distal portion of the stylet ofFIG. 4 protruding from the distal region of the cannula ofFIG. 2 , with the distal region of the cannula having a directional electrode; -
FIGS. 9-10 are plan and perspective views, respectively, of the stylet ofFIG. 4 partially inserted into the cannula ofFIG. 2 ; -
FIG. 11 is a is a plan view of the stylet ofFIG. 4 fully inserted into the cannula ofFIG. 2 in an unlocked position; -
FIG. 12 is perspective view of the locking cap of the fully inserted stylet ofFIG. 11 , shown in an unlocked position; -
FIG. 13 is a perspective view of the cannula and stylet combination in the unlocked position ofFIG. 11 ; -
FIGS. 14-15 are perspective and plan views, respectively, of the cannula and stylet combination ofFIG. 13 in the locked position; -
FIGS. 16-17 are perspective views of a T-handle forming part of the pedicle access system ofFIG. 1 ; -
FIG. 18 is a perspective view of the pedicle access system ofFIG. 1 with the cannula and stylet combination ofFIG. 13 fully inserted and locked in the T-handle; -
FIG. 19 is an exploded perspective view of a pedicle access system according to an alternative embodiment of the present invention; -
FIG. 20 is a perspective view of the assembled pedicle access system ofFIG. 19 ; -
FIGS. 21-22 are plan and perspective views, respectively, of a cannula forming part of the pedicle access system ofFIG. 20 ; -
FIGS. 23-24 are plan and perspective views, respectively, of a coupling element forming part of the cannula ofFIG. 21 ; -
FIG. 25 is a perspective view of a stylet forming part of the pedicle access system ofFIG. 20 ; -
FIG. 26 is a perspective view of a handle forming part of the stylet ofFIG. 25 ; -
FIG. 27 is a perspective view of the pedicle access system ofFIG. 20 including an enlarged view of a distal region thereof; -
FIGS. 28-30 are perspective, top plan and bottom plan views, respectively, of a lock collar forming part of the pedicle access system ofFIG. 20 ; -
FIG. 31 is an exploded perspective view of a pedicle access system according to a further alternative embodiment of the present invention; -
FIGS. 32-33 are perspective views of an assembled pedicle access system ofFIG. 31 ; -
FIG. 34 is a front view of the pedicle access system ofFIG. 32 ; -
FIGS. 35-36 are side and perspective views, respectively, of a cannula forming part of the pedicle access system ofFIG. 31 ; -
FIGS. 37-38 are side and perspective views, respectively, of a coupling element forming part of the cannula ofFIG. 35 ; -
FIG. 39 is a perspective view of a stylet forming part of the pedicle access system ofFIG. 31 ; -
FIG. 40 is a perspective view of a needle forming part of the stylet ofFIG. 39 ; -
FIGS. 41-42 are perspective and plan views, respectively, of a handle forming part of the stylet ofFIG. 39 ; -
FIGS. 43-44 are perspective and plan views, respectively, of a lock collar forming part of the pedicle access system ofFIG. 31 ; -
FIG. 45 is a bottom plan view of a handle ofFIG. 46 in engagement with a lock collar ofFIG. 43 ; -
FIG. 46 is a perspective view of a retractable insulation sheath forming part of the pedicle access system ofFIG. 31 ; -
FIG. 47 is a perspective view of an insulation tube forming part of the retractable insulation sheath ofFIG. 46 ; -
FIG. 48 is a perspective view of a retraction tube forming part of the retractable insulation sheath ofFIG. 46 ; -
FIGS. 49-50 are perspective views of a sheath attachment element forming part of the pedicle access system ofFIG. 31 ; and -
FIG. 51 is a perspective view of an example of a neurophysiology system capable of connecting to the pedicle access systems ofFIGS. 1, 19 and 31 to conduct pedicle integrity tests. -
FIGS. 52-53 are side and perspective views, respectively, of a cannula forming part of the pedicle access system ofFIG. 51 ; -
FIG. 53A are cross-sectional views taken alonglines 53A-53A inFIG. 53 illustrating the relative size of the insulated and non-insulated regions of the cannula ofFIGS. 51-53 ; and -
FIG. 54 is a perspective view of an example of a neurophysiology system capable of connecting to the pedicle access systems ofFIGS. 1, 19, and 31 to conduct pedicle integrity tests. - Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The insulated pedicle access system and related methods disclosed herein boast a variety of inventive features and components that warrant patent protection, both individually and in combination.
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FIG. 1 illustrates an example of apedicle access system 10 according to one embodiment of the present invention. Thepedicle access system 10 includes acannula 12, astylet 14, and a T-handle 16. As will be described with greater detail below, thepedicle access system 10 may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during formation of the pilot hole. To do this, thecannula 12 andstylet 14 may be lockingly mated to form a cannula/stylet combination 15 which may be inserted through an operating corridor to the pedicle target site, using the T-handle 16 to facilitate easy movement and positioning of the cannula/stylet combination 15. The cannula/stylet combination 15 may be driven into the bone at the target site to form a pilot hole while a stimulation signal is applied to thepedicle access system 10 and conducted to the target site to assess the integrity of the pedicle during hole formation. The T-handle 16 may be detached from the cannula/stylet combination 15 to facilitate the use of various surgical tools (such as by way of example only a forceps, mallet, or needle driver) after proper positioning of thecannula 12 andstylet 14. Additionally, removal of the T-handle after proper positioning of the cannula/stylet combination 15 provides a less obstructed view of the operating corridor and surgical target site. As shown and described herein, thecannula 12 andstylet 14 are generally cylindrical in shape. However, it should be understood thatcannula 12 andstylet 14 may be provided in any suitable shape having any suitable cross-section (e.g. generally oval or polygonal) without deviating from the scope of the present invention. -
FIG. 2 illustrates an example of acannula 12 forming part ofpedicle access system 10.Cannula 12 includes acoupling element 18 and anelongated shaft 20. An interior lumen extends through thecannula 12 from afirst opening 22 located at aproximal region 30 of thecoupling element 18 to asecond opening 24 located at adistal end 21 of theelongated shaft 20.Elongated shaft 20 may be composed of any conductive material such as metal, for example. A polymeric coating is provided on a substantial portion of the exterior surface ofelongated shaft 20 such thatelongated shaft 20 comprises aninsulated portion 26 and anuninsulated portion 28. Althoughelongated shaft 20 is shown having a single uniform diameter, it will be appreciated that one or more diameter changes may be incorporated along theelongated shaft 20 without deviating from the scope of the present invention. - With reference to
FIG. 3 ,coupling element 18 comprises aproximal region 30, acenter section 32, and abase portion 34.Proximal region 30 is dimensioned to engage with the stylet 14 (described below).Proximal region 30 may include at least onetab member 36 that protrudes in a generally lateral direction from theproximal region 30. By way of example only, as shown inFIG. 3 proximal region 30 includes twotab members 36 positioned opposite one another and adjacent tofirst opening 22. As will be described in greater detail below,tab members 36 function to lock thecannula 12 andstylet 14 together.Center section 32 is dimensioned to be received within T-handle aperture 66 (FIG. 16 ) as described in further detail below.Center section 32 may be provided with at least onecutout 38 dimensioned to receive a locking mechanism 68 (FIG. 16 ) incorporated into T-handle 16 to secure the T-handle 16 to the cannula/stylet combination 15, or optionally to thecannula 12 only. Thebase 34 has a circumference that is greater than the circumference ofcenter section 32, such that aledge 39 is formed at the interface ofcenter section 32 and thebase portion 34. Theledge 39 engages therim 72 of T-handle 16 so as to minimize potential stress on a T-handle locking mechanism 68 discussed below. -
FIG. 4 illustrates an example of astylet 14 forming part of thepedicle access system 10.Stylet 14 includes a lockingcap 40 and aneedle element 42. Lockingcap 40 has a similar size and shape to centersection 32, and is similarly dimensioned to be received within T-handle aperture 66, discussed below. Lockingcap 40 includes adistal end 44 and aproximal end 46. As illustrated inFIG. 5 , lockingcap 40 includes a generallycylindrical aperture 48 having an opening atdistal end 44 and extending in a proximal direction at least partially the length of lockingcap 40. Generallycylindrical aperture 48 is dimensioned to receive the generally cylindricalproximal region 30 ofcannula 12. Furthermore, lockingcap 40 includes at least one longitudinal channel 50 (defined by an axis extending through the proximal and distal ends 46, 44 respectively) and at least onelateral channel 52 extending generally perpendicularly fromlongitudinal channel 50.Longitudinal channel 50 andlateral channel 52 each extend from anexterior surface 54 through aninterior surface 56 intoaperture 48. Preferably, the number oflongitudinal channels 50 andlateral channels 52 correspond to the number oftab members 36 oncannula 12. By way of example only (and as shown inFIGS. 3-5 ),cannula 12 includes twotab members 36 andstylet 14 includes twolongitudinal channels 50 and twolateral channels 52. -
Longitudinal channel 50 initiates at thedistal end 46 and has a length corresponding to the length of the generally cylindrical 48.Lateral channel 52 initiates at the proximal end oflongitudinal channel 50 and extends generally perpendicularly therefrom such that together the longitudinal andlateral channels Longitudinal channel 50 andlateral channel 52 function to interact with thetab 36 oncannula 12, so as to lock thestylet 14 andcannula 12 together.Longitudinal channel 50 has a width dimension sufficient to accommodate the length oftab member 36 andlateral channel 52 has a height dimension sufficient to accommodate the height of tab member 36 (best viewed inFIG. 12 ). A ridge 58 (shown inFIG. 12 ) may be positioned along thedistal-most edge 53 and/orproximal-most edge 55 of thelateral channel 52 to engage withtab member 36 and provide a locking means for the cannula/stylet combination 15. Additionally, a portion ofexterior surface 54 adjacent toproximal end 46 may comprise a rampedsurface 49 such that the circumference ofdistal end 44 is slightly greater than the circumference ofproximal end 46, so as to facilitate engagement with the T-handle 16. - The
needle element 42 comprises an elongated shaft 41 having aproximal region 43 and adistal region 45. Theproximal region 43 may be attached to the interior of lockingcap 40 betweenproximal end 46 andaperture 48. Elongated shaft 41 extends distally fromproximal region 43 with a significant portion protruding generally perpendicularly from the opening ofaperture 48.Needle element 42 is dimensioned to be inserted through the interior lumen ofcannula 12. Thedistal region 45 generally includes a distal portion of elongated shaft 41 and a shapedtip 47 having any form or shape capable of being driven into the pedicle to create a pilot hole. By way of example only, shapedtip 47 may have a beveled or double diamond form. As illustrated inFIG. 6 , whenneedle element 42 is fully inserted intocannula 12, at least a portion of distal region 45 (including shaped tip 47) may protrude slightly from thesecond opening 24 ofcannula 12. Due to the insulated nature ofcannula 12, the portion ofneedle element 42 that protrudes fromcannula 12 effectively constitutes astimulation region 60. Thestimulation region 60 may include thedistal region 45 and/or the shapedtip 47. - According to a further aspect of the present invention, any part of the needle element 42 (e.g. the elongated shaft 41,
distal region 45 and/or shaped tip 47) may be provided with a coating to insulate and therefore limit or reduce thestimulation region 60 to a desired configuration. For example, thedistal tip 47 may have an insulation coating to effectuate astimulation region 60 consisting of the portion of thedistal region 45 of theneedle element 42 between theinsulated cannula 12 and the insulateddistal tip 47. Alternatively, the entirety ofneedle element 42 may be provided with an insulative coating and thedistal region 21 ofcannula 12 may be provided with (for example) one or more uninsulated portions 29 (FIG. 7 ) and/or one or more directional electrodes 31 (FIG. 8 ) forming astimulation region 61. These alternative arrangements serve to mitigate an apparent phenomenon in which certain geometries (e.g. points and edges) tend to generate significantly higher current densities and therefore are much more efficient at exciting a nearby nerve, even through bone tissue. As a result, instrumentation having these geometries may show a lower stimulation threshold (and thus causing an EMG monitoring system to indicate a breach in an intact pedicle) unless this phenomenon is otherwise compensated for. -
Needle element 42 may be composed of a conductive material, such as metal. Alternatively,needle element 42 may be composed of a non-conductive material with one or more embedded conductive elements at or near the distal end (e.g.distal region 45 and/or shaped tip 47) capable of being communicatively linked with a pedicle integrity testing system. -
FIGS. 9-15 illustrate the formation of the cannula/stylet combination 15. InFIGS. 9-10 stylet 14 is introduced intocannula 12.Needle element 42 ofstylet 14 is inserted into the interior lumen ofcannula 12 through thefirst opening 22 ofcoupling element 18. The lockingcap 40 ofstylet 14 is positioned such that itslongitudinal channels 50 are aligned with thetab members 36 ofcannula 12. Theproximal region 30 ofcannula 12 is received into theaperture 48 of lockingcap 40, and thetab members 36 pass through thelongitudinal channels 50 as insertion ofneedle element 42 progresses. Insertion is complete when theproximal portion 30 is fully received byaperture 48, leaving the lockingcap 40 in the “unlocked” position illustrated inFIGS. 11-13 . As mentioned above, thedistal region 45 ofneedle element 42 including shaped tip 47 (and the stimulation region 60) may protrude from thesecond opening 24 of theelongated shaft 20 ofcannula 12 whenstylet 14 is fully inserted, shown inFIG. 11 . In the unlocked position,tab members 36 are positioned at the proximal end oflongitudinal channels 50 where the channels intersectlateral channels 52. At this point, the corresponding shapes of the lockingcap 40 ofstylet 14 andcenter section 32 ofcannula 12 are out of alignment. To lockstylet 14 in place and complete the combination, the lockingcap 40 is rotated until it is aligned with thecenter section 32 as illustrated inFIGS. 14-15 . As thelateral channels 52 rotate around thetab members 36,ridges 58 come into contact with thetab members 36. The ridges may not pass thetab members 36 if the lockingcap 40 is not rotated with enough force to deform theridges 58. Once theridges 58 have deformed, the rotation may continue towards the final position. The lockingcap 40 andcenter section 32 become aligned and theridges 58 may clear thetab members 36 and regain their original forms, thereby preventing inadvertent rotation of the lockingcap 40 back to the unlocked position. -
FIG. 16 illustrates an example of a T-handle 16 forming part of thepedicle access system 10. T-handle 16 includes agrip region 64, anaperture 66 for engaging thecannula 12 or cannula/stylet combination 15, and alocking mechanism 68 for securing the T-handle to thecannula 12.Grip region 64 may be provided in any number of suitable shapes and sizes that may aid the user in holding and manipulating thepedicle access system 10 during use. The T-handle aperture 66 is dimensioned to snugly receive both the lockingcap 40 andcenter section 32 when they are aligned in the locked position as described above. Thelocking mechanism 68 preferably comprises a lever having one end that is integrated into the aperture wall and afree end 70 extending therefrom. The majority of the locking mechanism 68 (excluding free end 70) may comprise the same thickness as the aperture wall and does not protrude, interiorly or exteriorly, from the aperture wall. In its “natural” state, the interior surface offree end 70 protrudes into theaperture 66 space. The interior surface offree end 70 is dimensioned to engage thecutout 38 in thecenter section 32 ofcannula 12. Furthermore, as illustrated inFIG. 17 , the interior surface offree end 70 may be slightly ramped, such that the edge further from the aperture opening protrudes further into the aperture than the edge closer to the aperture opening. The ramped portion works in concert with the rampedsurface 49 at theproximal end 46 of lockingcap 40 to force thefree end 70 out of its natural state as the lockingcap 40 ofstylet 14 andcenter section 32 ofcannula 12 are received into the T-handle aperture 66. When the lockingcap 40 andcenter section 32 are fully inserted into the T-handle aperture 66, as illustrated inFIG. 18 , the interior surface offree end 70 aligns with thecutout 38 in thecenter section 32 andfree end 70 returns to its natural state, thus locking the T-handle 16 to thecannula 12. Furthermore, as the lockingcap 40 andcenter section 32 are fully inserted into the T-handle aperture 66, theledge 39 engages therim 72. This interaction functions to minimize potential stress on the T-handle locking mechanism 68 by increasing the surface area that receives force applied by the user. To remove the T-handle 16, thefree end 70 may be lifted to disengage with thecutout 38, and the T-handle may be pulled off. Optionally, T-handle 16 may be cannulated (not shown) such that an interior lumen extends from an opening on the top of the handle into theaperture 66. -
FIGS. 19-20 illustrate an example of apedicle access system 110 according to an alternative embodiment of the present invention. Thepedicle access system 110 includes acannula 112, astylet 114, and alock collar 116. As described above in relation topedicle access system 10,pedicle access system 110 may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during formation of the pilot hole. To do this, thecannula 112 andstylet 114 may be lockingly mated and inserted through an operating corridor to the pedicle target site, using thehandle portion 140 of thestylet 114 to facilitate easy movement and positioning ofpedicle access system 110. Thepedicle access system 110 may be driven into the bone at the target site to form a pilot hole while a stimulation signal is applied and conducted to the target site to assess the integrity of the pedicle during hole formation. As shown and described herein, thecannula 112 andstylet 114 are generally cylindrical in shape. However, it should be understood thatcannula 112 andstylet 114 may be provided in any suitable shape having any suitable cross-section (e.g. generally oval or polygonal) without deviating from the scope of the present invention. -
FIGS. 21-22 illustrate an example of acannula 112 forming part ofpedicle access system 110.Cannula 112 includes acoupling element 118 and anelongated shaft 120. An interior lumen extends through thecannula 112 from afirst opening 122 located at aproximal region 130 of thecoupling element 118 to asecond opening 124 located at adistal end 121 of theelongated shaft 120.Elongated shaft 120 may be composed of any conductive material such as metal, for example. A polymeric coating may be provided on a substantial portion of the exterior surface ofelongated shaft 120 such thatelongated shaft 120 comprises aninsulated portion 126 and an uninsulated portion 128 (the edge of the coating and thus the boundary betweenportions callout 127 inFIGS. 21-22 ).Elongated shaft 120 may include any number of diameter changes incorporated along its length without deviating from the scope of the present invention. In the alternative,elongated shaft 120 may be provided with a uniform diameter along its length. - With reference to
FIGS. 23-24 ,coupling element 118 comprises aproximal region 130, acenter section 132, and adistal portion 134.Proximal region 130 includes anengagement region 131 dimensioned to engage with thehandle portion 140 of the stylet 114 (as described in further detail below). Theengagement region 121 may be provided in any suitable geometric configuration to allow for secure mating with theengagement tabs 144 of thehandle 140. By way of example only, thecoupling element 118 is shown inFIGS. 23-24 having ahexagonal engagement region 131, however other shapes are possible.Proximal region 130 may include at least onetab member 136 that protrudes in a generally lateral direction from theproximal region 130. By way of example only, as shown inFIG. 24 proximal region 130 includes twotab members 136 positioned opposite one another and adjacent tofirst opening 122.Tab members 136 may be utilized to attach supplemental instruments and/or apparatuses to thecannula 112.Center section 132 may be provided with a diameter that is larger than the diameters of theproximal region 130 anddistal portion 134, and may be provided with a plurality ofridges 133 and/or other features for the purpose of providing a suitable gripping area for a user. Thedistal portion 134 is dimensioned to engage with theelongated shaft 120 of thecannula 112. -
FIG. 25 illustrates an example of astylet 114 forming part of thepedicle access system 110.Stylet 114 includes ahandle portion 140 and aneedle element 142.Handle portion 140 may (by way of example) resemble a T-handle for providing a user with a suitable gripping means.Handle portion 140 may be provided with a pair ofengagement tabs 144 extending distally fromhandle portion 140.Engagement tabs 144 extend generally perpendicularly from thehandle 140 and generally parallel to one another such that theengagement tabs 144 collectively form aninterior space 146.Interior space 146 is dimensioned to receive theproximal region 130 of thecoupling element 118 of thecannula 112. Eachengagement tab 144 is provided with a medial (inwardly-facing)indentation 148 and a lateral (outwardly-facing)indentation 150.Medial indentations 148 are dimensioned to engage theengagement region 131 of thecoupling element 118, described above. For this reason, themedial indentations 148 may be provided with any geometry complementary to the shape of theengagement region 131 such that when mated, the engagement tabs 144 (via the medial indentations 148) will prevent movement of theengagement region 131, in effect locking thecannula 112 in place relative to thestylet 114. Thelateral indentations 150 are dimensioned to interact with the first andsecond protrusions lock collar 116 described in further detail below. - The
needle element 142 comprises anelongated shaft 152 having aproximal region 154 and adistal region 156. Theproximal region 154 may be attached to the interior ofhandle portion 140.Elongated shaft 152 extends distally fromproximal region 154 and generally perpendicularly from thehandle 140.Needle element 142 is dimensioned to be inserted through the interior lumen ofcannula 112. Thedistal region 156 generally includes a distal portion ofelongated shaft 152 and ashaped tip 158 having any form or shape capable of being driven into the pedicle to create a pilot hole. By way of example only, shapedtip 158 may have a beveled or double diamond form. As illustrated inFIG. 27 , whenneedle element 142 is fully inserted intocannula 112, at least a portion of distal region 156 (including shaped tip 158) may protrude slightly from thesecond opening 124 ofcannula 112. Due to the insulated nature ofcannula 112, the portion ofneedle element 142 that protrudes fromcannula 112 effectively constitutes astimulation region 160. Thestimulation region 160 may include thedistal region 152 and/or the shapedtip 158. - According to a further aspect of the present invention, any part of the needle element 142 (e.g. the
elongated shaft 152,distal region 156 and/or shaped tip 158) may be provided with a coating to insulate and therefore limit or reduce thestimulation region 160 to a desired configuration. For example, thedistal tip 158 may have an insulation coating to effectuate astimulation region 160 consisting of the portion of thedistal region 156 of theneedle element 142 between theinsulated cannula 112 and the insulateddistal tip 158. This coating serves to mitigate an apparent phenomenon in which certain geometries (e.g. points and edges) tend to generate significantly higher current densities and therefore are much more efficient at exciting a nearby nerve, even through bone tissue. As a result, instrumentation having these geometries may show a lower stimulation threshold (and thus causing an EMG monitoring system to indicate a breach in an intact pedicle) unless this phenomenon is otherwise compensated for. -
Needle element 142 may be composed of any conductive material, such as metal. Alternatively,needle element 142 may be composed of a non-conductive material with one or more embedded conductive elements at or near the distal end (e.g.distal region 156 and/or shaped tip 158) capable of being communicatively linked with a pedicle integrity testing system. - With reference to
FIGS. 28-30 , alock collar 116 is provided to lockingly mate thecannula 112 and thestylet 114.Lock collar 116 has a generally cylindrical overall shape, and includes aproximal portion 162, adistal portion 164 and aninterior lumen 166 extending therethrough. Theproximal portion 162 may have a diameter greater than that of thedistal portion 164 and is provided with a plurality offriction elements 168 to allow a user to grasp and turn thelock collar 116. Thedistal portion 164 includes a generally oval-shapedopening 170 providing access to thelumen 166. Theopening 170 further includes a pair of opposingfirst protrusions 172 and a pair of opposingsecond protrusions 174 located along the inside edge ofopening 170.First protrusions 172 are located 180° from one another and are positioned at the long ends of the oval-shapedopening 170.Second protrusions 174 are positioned at the narrow sides of the oval-shaped opening 170 (and thus are located at 90° intervals from thefirst protrusions 172 and 180° from one another). First andsecond protrusions lateral indentations 150 provided on theengagement tabs 144 of thehandle 140, described above. - The
interior lumen 166 is dimensioned to receive both of theengagement tabs 144 of thehandle 140. Initially, thepedicle access system 110 of the present invention may be provided with thelocking collar 116 attached to thestylet 114 in an initial position. This initial position is defined by thefirst protrusions 172 resting in thelateral indentations 150 of theengagement tabs 144 of thehandle 140. Upon insertion of theneedle element 142 into thecannula 112, thedistal region 130 of thecoupling element 118 ofcannula 112 will enter thespace 146 of thehandle 140 such that themedial indentations 148 are aligned with (but not yet engaging) theengagement region 131 of thecoupling element 118. At this point, a user would then rotate thelock collar 116 90° to a second position such that thesecond protrusions 174 rest in thelateral indentations 150. Due to the oval-shaped nature of theopening 170, upon rotation of thelock collar 116, theengagement tabs 144 will be forced toward one another, and themedial indentations 148 will come in contact with and positively engage theengagement region 131. As noted previously, this positive engagement prevents thecannula 112 from moving. At the same time, thelock collar 116 serves to lock theengagement tabs 114 in place, effectively locking thecannula 112 and thestylet 114 together. Thepedicle access system 110 is now ready for use. -
FIGS. 31-34 illustrate an example of apedicle access system 210 according to a further alternative embodiment of the present invention. Thepedicle access system 210 includes acannula 212, astylet 214, alock collar 216 and aretractable insulation sheath 217. As described above in relation topedicle access systems pedicle access system 210 may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during formation of the pilot hole. To do this, thecannula 212 andstylet 214 may be lockingly mated and inserted through an operating corridor to the pedicle target site, using thehandle portion 240 of thestylet 214 to facilitate easy movement and positioning ofpedicle access system 210. Thepedicle access system 210 may be driven into the bone at the target site to form a pilot hole while a stimulation signal is applied and conducted to the target site to assess the integrity of the pedicle during pilot hole formation. Theretractable insulation sheath 217 functions to ensure maximum efficiency of the stimulation signal as by limiting or preventing shunting of the signal during pilot hole formation. As shown and described herein, thecannula 212,stylet 214 andretractable insulation sheath 217 are generally cylindrical in shape. However, it should be understood thatcannula 212,stylet 214 andsheath 217 may be provided in any suitable shape having any suitable cross-section (e.g. generally oval or polygonal) without deviating from the scope of the present invention. - The
retractable insulation sheath 217 functions to ensure maximum efficiency of the stimulation signal as by limiting or preventing shunting of the signal during pilot hole formation. With specific reference toFIGS. 32-34 , this is accomplished by providing atubular insulation member 274 slideably mated with ahousing member 276 described in greater detail below. In an initial position (shown inFIGS. 33-34 ), thetubular insulation member 274 is fully extended such that it extends at least to thetip 258 of thestylet 214. Upon formation of a pilot hole in a pedicle (or other piece of bone), thestylet 214 will advance into the bone while the insulation sheath remains outside the bone (a position shown by way of example inFIG. 32 ). Due to the insulative properties of thesheath 217, the electrical current when supplied will be directed into the pilot hole by the uninsulated portion of thecannula 212 andstylet 214 while prevented from shunting outside of the hole by thesheath 217. -
FIGS. 35-36 illustrate an example of acannula 212 forming part ofpedicle access system 210 of the present invention.Cannula 212 includes acoupling element 218 and anelongated shaft 220. An interior lumen extends through thecannula 212 from afirst opening 222 located at aproximal region 230 of thecoupling element 218 to asecond opening 224 located at adistal end 221 of theelongated shaft 220.Elongated shaft 220 may be composed of any conductive material such as metal, for example.Elongated shaft 220 may include any number of diameter changes incorporated along its length without deviating from the scope of the present invention. In the alternative,elongated shaft 220 may be provided with a uniform diameter along its length. - With reference to
FIGS. 37-38 ,coupling element 218 comprises aproximal region 230, acenter section 232, and adistal portion 234.Proximal region 230 includes anengagement region 231 dimensioned to engage with thehandle portion 240 of the stylet 214 (as described in further detail below). Theengagement region 231 may be provided in any suitable geometric configuration to allow for secure mating with theengagement tabs 144 of thehandle 140. By way of example only, thecoupling element 218 is shown inFIGS. 37-38 having a plurality of triangular-shapedindentations 233, however other shapes are possible.Proximal region 230 may include at least onetab member 236 that protrudes in a generally lateral direction from theproximal region 230. By way of example only, as shown inFIG. 38 proximal region 230 includes twotab members 236 positioned opposite one another and adjacent tofirst opening 222.Tab members 236 may be utilized to attach supplemental instruments and/or apparatuses to thecannula 212.Center section 232 may be provided with a diameter that is larger than the diameters of theproximal region 230 anddistal portion 234, and may be provided with a plurality ofridges 235 and/or other features for the purpose of providing a suitable gripping area for a user. Thedistal portion 234 is dimensioned to engage with theelongated shaft 220 of thecannula 212 and may further be provided with arecess 237 for engagement with thesheath attachment element 292, described in further detail below. -
FIG. 39 illustrates an example of astylet 214 forming part of thepedicle access system 210.Stylet 214 includes ahandle portion 240 and aneedle element 242. Referring toFIGS. 41-42 , thehandle portion 240 may (by way of example) resemble a T-handle for providing a user with a suitable gripping means. By way of example only, thehandle portion 240 may have a substantially hollow interior that is not fully enclosed.Handle portion 240 includes anaperture 243 and a pair ofengagement tabs 244 extending distally fromhandle portion 240.Aperture 243 is dimensioned to allow passage of theneedle element 242 from thehandle portion 240.Engagement tabs 244 extend generally perpendicularly from thehandle 240 and generally parallel to one another such that theengagement tabs 244 collectively form aninterior space 246.Interior space 246 is dimensioned to receive the proximal region 1230 of thecoupling element 218 of thecannula 212. Eachengagement tab 244 is provided with a medial (inwardly-facing)protrusion 248.Medial protrusions 248 are dimensioned to engage theengagement region 231 of thecoupling element 218, described above. For this reason, themedial protrusions 248 may be provided with any geometry complementary to the shape of theengagement region 231 such that when mated, the engagement tabs 244 (via the medial protrusions 248) will prevent movement of theengagement region 231, in effect locking thecannula 212 in place relative to thestylet 214. - With reference to
FIG. 40 , theneedle element 242 comprises anelongated shaft 252 having aproximal region 254 and adistal region 256. Theproximal region 254 includes anattachment element 257 configured to attach to the interior ofhandle portion 240. Theattachment element 257 is also configured to provide a point of contact for an electrical stimulation source (e.g. a clip attached to an electrical source).Elongated shaft 252 extends distally fromproximal region 254 and generally perpendicularly from the handle 240 (and through aperture 243).Needle element 242 is dimensioned to be inserted through the interior lumen ofcannula 212. Thedistal region 256 generally includes a distal portion ofelongated shaft 252 and ashaped tip 258 having any form or shape capable of being driven into the pedicle to create a pilot hole. By way of example only, shapedtip 258 may have a beveled or double diamond form. Whenneedle element 242 is fully inserted intocannula 212, at least a portion of distal region 256 (including shaped tip 258) may protrude slightly from thesecond opening 224 ofcannula 212. -
Needle element 242 may be composed of any conductive material, such as metal. Alternatively,needle element 242 may be composed of a non-conductive material with one or more embedded conductive elements at or near the distal end (e.g.distal region 256 and/or shaped tip 258) capable of being communicatively linked with a pedicle integrity testing system. Although shown as separate parts, thestylet 214 is preferably provided as a single unit, with theneedle element 242 andattachment element 257 molded in place in thehandle 240. - With reference to
FIGS. 43-44 , alock collar 216 is provided to lockingly mate thecannula 212 and thestylet 214.Lock collar 216 has a generally cylindrical overall shape, and includes aproximal portion 262, adistal portion 264 and aninterior lumen 266 extending therethrough. Theproximal portion 262 may have a diameter greater than that of thedistal portion 264 and is provided with a plurality offriction elements 268 to allow a user to grasp and turn thelock collar 216. Thedistal portion 264 includes a generally oval-shapedopening 270 providing access to thelumen 266. Theopening 270 further includes a pair of opposingprotrusions 272 located along the inside edge ofopening 270.Protrusions 272 are located 180° from one another and are positioned approximately midway between the “long ends” and the “narrow sides” of the oval-shapedopening 270.Protrusions 272 are dimensioned to engage the sides ofengagement tabs 244 of thehandle 240, described above. - The
interior lumen 266 is dimensioned to receive both of theengagement tabs 244 of thehandle 240. Initially, thepedicle access system 210 of the present invention may be provided with thelocking collar 216 attached to thestylet 214 in an initial position. This initial position is defined by theprotrusions 272 resting alongside theengagement tabs 244 of thehandle 240. Theengagement tabs 244 at this point are disposed in the “long ends” of the oval-shapedopening 270. Upon insertion of theneedle element 242 into thecannula 212, thedistal region 230 of thecoupling element 218 ofcannula 212 will enter thespace 246 of thehandle 240 such that themedial protrusions 248 are aligned with (but not yet engaging) theengagement region 231 of thecoupling element 218. At this point, a user would then rotate thelock collar 216 90° to a second position such that theprotrusions 272 rest in against theengagement tabs 244 and theengagement tabs 244 rest in the “narrow sides” of the oval-shapedopening 270, as shown in FIG. 45. Due to the oval-shaped nature of theopening 270, upon rotation of thelock collar 216, theengagement tabs 244 will be forced toward one another, and themedial protrusions 248 will come in contact with and positively engage theengagement region 231. As noted previously, this positive engagement prevents thecannula 212 from moving. At the same time, thelock collar 216 serves to lock theengagement tabs 214 in place, effectively locking thecannula 212 and thestylet 214 together. Thepedicle access system 210 is now ready for use. - According to a further aspect of the present invention, the
pedicle access system 210 may be provided with aretractable insulation sheath 217 to electrically insulate thecannula 212 andstylet 214. Theinsulation sheath 217 may be composed of a non-conductive material or coated with a non-conductive polymer coating to insulate thesheath 217. This prevents shunting of electrical current during pilot hole formation, increasing the efficiency with which the stimulation current is delivered to the target area. Referring toFIG. 46 , theinsulation sheath 217 includes aninsulation tube 274 and ahousing member 276. As seen inFIG. 47 , the insulation tube comprises a cannulated, elongated and generally cylindrical member having aproximal end 278 and adistal end 280. Theproximal end 278 includes at least onetab 282 configured to slideably engage thehousing member 276 as set forth below. In the example shown inFIG. 47 , theinsulation tube 274 includes a pair oftabs 282 positioned opposite one another, however any number oftabs 282 may be provided without departing from the scope of the invention. Thedistal end 280 may be provided with a generally taperedsurface 284 to allow for an improved interface with the bone. - Referring to
FIGS. 46 & 48 , thehousing member 276 comprises an elongated generally cylindrical member having aproximal end 286, adistal end 287 and aninterior lumen 288. Theproximal end 286 includes a shaped engagement feature 289 (e.g. a recess as shown) dimensioned to engage asheath attachment element 292 described in further detail below. Thehousing member 276 further includes at least oneelongated track 290 in the form of a cutout section extending substantially the length of thehousing member 276. Thetrack 290 is dimensioned to slideably receive thetabs 282 of theinsulation tube 274 such that theinsulation tube 274 is allowed to migrate within thelumen 288. - With reference to
FIGS. 49-50 , an example of asheath attachment element 292 is shown. Thesheath attachment element 292 may be provided as a generally cylindrical member having aninterior lumen 293.Sheath attachment element 292 is dimensioned to provide a snap-fit engagement with both thehousing member 276 and thecoupling element 218 ofcannula 212. Thelumen 293 is provided with afirst ridge 294 near a distal end for secure engagement withrecess 289 of thehousing member 276. Similarly, thelumen 293 is provided with a second ridge (not shown) near a proximal end for engagement withrecess 237 of the coupling element 218 (FIG. 37 ). During assembly of thepedicle access system 210, theretractable insulation sheath 217 may be provided with thesheath attachment element 292 mated to thehousing member 276. Thecannula 212 is then inserted into theinsulation sheath 217 andsheath attachment element 292 will then engage thecoupling element 218, thus securely attaching theinsulation sheath 217 to thepedicle access system 210. - In use, the
pedicle access system 210 is provided with theinsulation tube 274 in a first, fully extended position (e.g.FIG. 33 ). Theinsulation tube 274 will remain in this position as thepedicle access system 210 is advanced through an operative corridor to a bony target site (e.g. a pedicle). Upon initial engagement with the bony structure, thetip 258 of theneedle element 242 and thedistal end 280 of theinsulation tube 274 may contact the bone at approximately the same time. At this point the user may want to begin monitoring the integrity of the pilot hole formation by using a stimulation signal as described below. As theneedle 242 is advanced into the bone, forming a pilot hole, thedistal end 280 remains engaged to the outside surface of the bone. At the same time, the proximal end 278 (including tabs 282) of the insulation tube will advance proximally along thetrack 290 of thehousing member 276. Due to the insulated nature ofinsulation tube 274, the portion ofneedle element 242 andcannula 212 that protrude frominsulation tube 274 effectively constitute a stimulation region 260 (FIG. 32 ). As theneedle 242 andcannula 212 are advanced into the bony structure (and theinsulation tube 274 remains on the outside of the bony structure), thestimulation region 260 becomes larger. Upon completion of the pilot hold formation, theneedle 242 andcannula 212 are withdrawn from the bony structure, and thepedicle access system 210 may be removed from the operative corridor. A spring (not shown) or other control mechanism may be provided to limit the extent of migration of theinsulation tube 274 and/or provide a means for theinsulation tube 274 to bias toward returning to the fully extended position upon removal of theneedle 242 from the pilot hole in the pedicle. - In a significant aspect of the present invention, the
pedicle access systems pedicle access systems - With reference to
FIG. 51 , an example of onesuch neurophysiology system 300 includes adisplay 301, acontrol unit 302, apatient module 304, anEMG harness 306, including eight pairs ofEMG electrodes 308 and areturn electrode 310 coupled to thepatient module 304, and a host ofsurgical accessories 312, including an electric coupling device 316 capable of being coupled to thepatient module 304 via one or moreaccessory cables 314. - The
neurophysiology system 300 performs pedicle integrity assessments by determining the amount of electrical communication between a stimulation signal and the adjacent nerve root. To do this, a stimulation signal is applied to the pilot hole or pedicle screw via one of thesurgical accessories 312. TheEMG electrodes 308, positioned over the appropriate muscles, measure the EMG responses corresponding to the stimulation signal. The relationship between the EMG response and the stimulation signal is then analyzed by the system and the results are conveyed to the user on thedisplay 301. The basic theory underlying the pedicle integrity test is that given the insulating character of bone, a higher stimulation current (or current density) is required to evoke an EMG response when the stimulation signal is applied to an intact pedicle as opposed to a breached pedicle. Thus, if EMG responses are evoked by stimulation currents (or current densities) lower than a predetermined safe level, the surgeon may be alerted that there is a possible breach. The neurophysiology system may be provided with software capable of compensating for multiple safe stimulation thresholds based on different current densities being applied to the pedicle by certain geometries of different instruments. - The
pedicle access systems neurophysiology system 300 by attaching (not shown) theelectric coupling device 314 to (for example) theuninsulated region 28 of thecannula 12 ofpedicle access system 10. Theelectric coupling device 314 may comprise a number of possible embodiments which permit the device to attach and hold a surgical tool (such as the pedicle access system 10) while allowing transmission of a stimulation signal to the tool. One suchelectric coupling device 314 utilizes a spring-loaded plunger to hold the surgical tool and transmit the stimulation signal. Theplunger 318 is composed of a conductive material such as metal. Anonconductive housing 320 partially encases theplunger rod 318 about its center. Extending from thehousing 320 is anend plate 324. Anelectrical cable 326 connects theelectric coupling device 314 toneurophysiology system 300. A spring (not shown) is disposed within thehousing 320 such that in a natural or “closed” state theplunger 318 is situated in close proximity to theendplate 324. Exerting a compressive force on the spring (such as by pulling thecable 326 while holding the housing 320) causes a gap between theend plate 324 and theplunger 318 to widen to an “open” position, thereby allowing insertion of a surgical tool between theend plate 324 andplunger 318. Releasing thecable 326 allows the spring to return to a “closed” position, causing theplunger 318 to move laterally back towards the endplate such that a force is exerted upon the surgical tool and thereby holds it in place between theendplate 324 and theplunger 318. Thereafter the electrical stimulus may be passed from theneurophysiology system 300 through thecable 326 andplunger 318 to the surgical tool. - Alternatively, the electrical coupling device may be embodied in the form of a
clip 328. Theclip 328 is comprised of two prongs hingedly coupled at acoupling point 330 such that theclip 328 includes anattachment end 332 and anon-attachment end 334. Astimulation electrode 336 is disposed on theattachment end 332 and communicates with anelectric cable 326 extending from thenon-attachment end 334 to theneurophysiology system 300. In a “closed” position the prong ends at theattachment end 332 touch. Depressing the prongs at thenon-attachment end 334 in a direction towards each other causes a gap to form between the prong ends at theattachment end 332. Positioning the “opened”attachment end 332 over a desired surgical tool (such as the pedicle access system 10) and releasing the force on thenon-attachment end 334 causes theattachment end 332 to pinch tight on the surgical tool and thereby allow the electrical stimulus to pass from neurophysiology system, through thestimulation electrode 336, to the surgical tool. - The
pedicle access system 10 may thus be used to safely access the pedicle and safely form a pilot hole. To do this, thecannula 12,stylet 14, and T-handle 16 are preferably all combined and locked together as described above. Using the T-handle 16 to control the movement and positioning of thepedicle access system 10, the surgeon may position the stimulation point on the desired target site. Next, theelectric coupling device 116 may be attached to theuninsulated region 28 ofcannula 12 and the T-handle 16 may be removed to facilitate the use of a tool such as a needle driver. Stimulation signals are delivered to thepedicle access system 10 and emitted from thestimulation region 60 as it is being driven in to the bone, forming the pilot hole. Should theneurophysiology system 300 report a potential breach of the pedicle, pilot hole formation may be halted and any steps deemed to be necessary by the surgeon, based on his or her professional judgment, may be taken to correct the problem. Alternatively, the electric coupling device 316 may be attached before positioning thepedicle access system 10, and theneurophysiology system 300 may be employed to monitor the proximity of any nerves during positioning. - In another significant aspect of the present invention, the
pedicle access system 10 may be used in conjunction with spinal fixation systems that require access to pedicle target sites and need pilot holes, including but not limited to those systems shown and described in commonly owned and co-pending U.S. patent application Ser. No. 11/031,506 filed Jan. 6, 2005, and commonly owned and co-pending Int'l Patent App. Ser. No. PCT/US05/032300 filed Sep. 8, 2005. After positioning thepedicle access system 10 on the desired pedicle target site and safely forming a pilot hole as described above, the T-handle 16 andstylet 14 may be unlocked and removed from thecannula 12, leaving thecannula 12 positioned in the pilot hole. Guide wires subsequently used by the spinal fixation systems may then be safely deployed to the pilot hole through thecannula 12. Once the guide wire is in position thecannula 12 may be removed from the target site and the surgeon may commence use of the surgical fixation system. - While the invention is susceptible to various modification and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope and spirit of the invention as defined herein.
Claims (20)
1. A method comprising:
making an insulated pedicle access system available for use, the insulated pedicle access system including:
a stylet having a handle and a needle attached to the handle; and
a cannula coupled to the handle such that the needle extends through the cannula;
advancing a distal end of the insulated pedicle access system into a bone as part of forming a pilot hole;
after the advancing, unlocking the stylet from the cannula; and
after the unlocking removing the stylet from the cannula while leaving the cannula positioned in the pilot hole.
2. The method of claim 1 , further comprising:
deploying a guide wire into the pilot hole through the cannula;
after deploying the guide wire, removing the cannula; and
advancing a pedicle screw along the guide wire and into the bone.
3. The method of claim 1 , further comprising:
placing an electrical stimulation source in electrical communication with the needle; and
delivering an electrical stimulation current from the electrical stimulation source to monitor integrity of the bone.
4. The method of claim 1 , wherein prior to unlocking the stylet from the cannula:
two or more protrusions of the stylet resist movement of the cannula relative to the stylet in a direction parallel to a length of the cannula.
5. The method of claim 1 , wherein the insulated pedicle access system further includes:
a lock collar having:
an interior lumen;
a first set of protrusions extending into the interior lumen; and
a second set of protrusions extending into the interior lumen;
6. The method of claim 5 , wherein unlocking the stylet from the cannula includes:
manipulating the lock collar such that the first and second set of protrusions transition from engaging with engagement tabs to no longer engaging with the engagement tabs.
7. The method of claim 6 ,
wherein the engagement tabs extend perpendicularly from the handle.
8. The method of claim 1 , wherein making an insulated pedicle access system available for use includes assembling the insulated pedicle access system.
9. The method of claim 8 , further comprising:
inserting the needle into the cannula such that a coupler of the cannula enters a space defined by the stylet handle and medial indentations of the handle are aligned with but not yet engaging the coupler.
10. The method of claim 9 , further comprising:
manipulating a lock collar such that the medial indentations engage with the coupler.
11. A method comprising:
making a stylet available for use, the stylet comprising:
a needle a proximal region and a distal region, the distal region including a shaped tip;
a handle portion connected to the needle; and
at least two engagement tabs extending from the handle portion,
making a cannula available for use, the cannula comprising:
an elongated shaft having a proximate end and a distal end and an interior lumen; and
a coupling element positioned at the proximate end of the elongated shaft, the coupling element having a proximal region and a distal region, wherein the proximal region including an engagement region, wherein the at least two engagement tabs are dimensioned to receive the cannula coupling element engagement region, and wherein the engagement tabs have one or more protrusions the one or more protrusions having geometry complementary to the shape of the engagement region;
decoupling the stylet from the cannula such that the one or more protrusions cease resisting movement of the engagement region relative to the stylet in a direction parallel to the stylet's length;
after decoupling the stylet from the cannula, removing the stylet from the cannula;
inserting a guide wire through the cannula; and
after inserting the guide wire, advancing a pedicle screw along the guide wire and into the bone.
12. The method of claim 11 , further comprising:
assembling an insulated pedicle access system by inserting the needle into the cannula; and
advancing the insulated pedicle access system into a bone as part of forming a pilot hole.
13. The method of claim 11 , further comprising:
placing an electrical stimulation source in electrical communication with the needle; and
delivering an electrical stimulation current from the electrical stimulation source to monitor bone integrity.
14. A method comprising:
advancing a distal portion of an insulated pedicle access system into a bone as part of forming a pilot hole; and
unlocking a stylet of the insulated pedicle access system from a cannula of the pedicle access system; and
removing the stylet from the cannula while leaving the cannula positioned in the pilot hole.
15. The method of claim 14 , further comprising:
deploying a guide wire into the pilot hole through the cannula;
after deploying the guide wire, removing the cannula; and
advancing a pedicle screw along the guide wire and into the bone.
16. The method of claim 14 , further comprising:
placing an electrical stimulation source in electrical communication with the stylet; and
delivering an electrical stimulation current from the electrical stimulation source to the bone to monitor integrity the bone.
17. The method of claim 14 , wherein prior to unlocking the stylet from the cannula:
two or more protrusions of the stylet resist movement of the cannula relative to the stylet in a direction parallel to a length of the cannula.
18. The method of claim 14 , wherein the insulated pedicle access system further includes:
a lock collar having:
an interior lumen;
a first set of protrusions extending into the interior lumen; and
a second set of protrusions extending into the interior lumen;
19. The method of claim 18 ,
wherein unlocking the stylet from the cannula includes manipulating the lock collar such that the first and second sets of protrusions transition from engaging with engagement tabs to no longer engaging with the engagement tabs; and
wherein the engagement tabs extend perpendicularly from the handle.
20. The method of claim 14 , further comprising:
prior to advancing the distal portion, inserting the needle into the cannula such that a coupler of the cannula enters a space defined by the stylet handle and medial indentations of the handle are aligned with but not yet engaging the coupler; and
manipulating a lock collar such that the medial indentations engage with the coupler.
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US20040225228A1 (en) * | 2003-05-08 | 2004-11-11 | Ferree Bret A. | Neurophysiological apparatus and procedures |
US7643884B2 (en) * | 2005-01-31 | 2010-01-05 | Warsaw Orthopedic, Inc. | Electrically insulated surgical needle assembly |
US7942826B1 (en) | 2005-06-06 | 2011-05-17 | Nuvasive, Inc. | Insulated pedicle access system and related methods |
US7842038B2 (en) * | 2006-05-04 | 2010-11-30 | Warsaw Orthopedic, Inc. | Method for using retractable stylet and cannula combination to form an opening in bone |
US20080108991A1 (en) * | 2006-11-08 | 2008-05-08 | General Electric Company | Method and apparatus for performing pedicle screw fusion surgery |
US8075601B2 (en) | 2007-04-30 | 2011-12-13 | Warsaw Orthopedic, Inc. | Deformity correction using neural integrity monitoring |
US8942797B2 (en) * | 2007-10-18 | 2015-01-27 | Innovative Surgical Solutions, Llc | Neural monitoring system |
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US10517502B1 (en) | 2019-12-31 |
US11213236B2 (en) | 2022-01-04 |
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