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WO2025096629A1 - Décompression vertébrale guidée par l'image avec vue oblique contralatérale - Google Patents

Décompression vertébrale guidée par l'image avec vue oblique contralatérale Download PDF

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Publication number
WO2025096629A1
WO2025096629A1 PCT/US2024/053685 US2024053685W WO2025096629A1 WO 2025096629 A1 WO2025096629 A1 WO 2025096629A1 US 2024053685 W US2024053685 W US 2024053685W WO 2025096629 A1 WO2025096629 A1 WO 2025096629A1
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Prior art keywords
cannula
tissue
spinal
patient
spinal stenosis
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PCT/US2024/053685
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English (en)
Inventor
Jatinder S. GILL
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Beth Israel Deaconess Medical Center Inc
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Beth Israel Deaconess Medical Center Inc
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Publication of WO2025096629A1 publication Critical patent/WO2025096629A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means

Definitions

  • the epidural space encloses the spinal canal and is a common area of spine pathology such as disc herniation or spinal stenosis.
  • spinal canal a common area of spine pathology
  • spinal stenosis a common area of spine pathology
  • open surgical approaches are the only reliable method to address these conditions in the spine. Given the invasive nature of the surgery, this remains a last resort and has long term deleterious consequences.
  • the epidural space can be accessed with needles and catheters.
  • the role of minimally invasive epidural surgery however remains limited. This is because of technological limitations to achieve safe, precise, and adequate decompression, as the space is very small for large rigid scopes.
  • Current minimally invasive percutaneous solutions also lack advanced visualization capabilities to guide procedures.
  • Epiduroscopy may also be used in combination with a laser for ablating a disc where the resulting debris can be resorbed or manual removal of small disc fragments.
  • the primary reason epiduroscopic surgery has not advanced involves the difficulties for visualizing the structures in the epidural space. Safety is also a concern because of collateral damage that could result in a sensitive nerve area or the possibility of damaging the wrong structure due to poor visibility.
  • the present invention addresses the problems of conventional endoscopic spinal decompression surgery by providing a flexible imaging endoscope having a diameter of 5 mm or less that provides visualization and ablation of tissue associated with a herniated disc, for example, without damaging adjacent structures. More specifically encroaching structures in the epidural space such as a herniated disc, or ligament (as seen in spinal stenosis), and other encroaching structures can be safely removed in a minimally invasive manner using a laser instrument. Devices and methods of preferred embodiments are used to displace the epidural membrane to enable visualization and ablation of a structure intruding into the epidural space.
  • Preferred embodiments utilize a rotating cannula to enter into the spinal region along a contralateral oblique axis to treat a spinal stenosis.
  • a tissue removal device can be inserted upon proper placement to capture and remove one or more portions of the stenosis tissue. Visualization methods and devices are employed to correctly position the cannula and the removal tool to treat the stenosis.
  • the cannula can be used to facilitate the delivery of fluids to the site during treatment.
  • a preferred embodiment can employ a tubular body having a working channel extending from a proximal end to a distal end in which a fiber optic device can be inserted for delivering light having an energy density sufficient to ablate tissue.
  • the tubular body can include device elements that distend the epidural diameter to provide improved visualization. By dilating the epidural space the user can more efficiently direct pulsed laser illumination onto tissues to be removed.
  • a lens or lens system can be used on the distal end of the fiber optic device to form a beam of light having a desired shape at a selected distance at which the tissue to be ablated is located.
  • a beam can have a selected spot size and energy distribution suitable to remove a selected volume of tissue in response to a pulse or sequence of pulses from the laser.
  • a CO2 laser is preferably used for the tissue removal process, although other lasers emitting in the infrared or near infrared portion of the electromagnetic spectrum can also be used such as a Nd: YAG or Ho: YAG lasers emitting in the range of 1400 nm to 1908 nm, for example, or light emitting diode (LED) lasers.
  • the waveguide used for delivery of CO2 laser light can employ different distal beam shaping elements to precisely define the ablation volume for each light pulse.
  • Further embodiments can employ other tissue removal devices to access and remove spinal defects.
  • tissue removal devices can include a laser, an ultrasound probe to deliver energy for tissue removal, a cutting or oblation tool such as a quantum molecular resonance (QMR) probe as described in further detail herein.
  • QMR quantum molecular resonance
  • a membrane can be used to deflect tissue away from the surgical space and can protect adjacent tissue from being damaged during removal of tissue from the target region.
  • the membrane can be temporarily deployed behind the target tissue to prevent damage to underlying tissue or structure.
  • the membrane can comprise a shape memory material that is delivered to the region in a first state and that deploys to have a different shape in a second state.
  • the material can comprise a metal such as nitinol, a polymer, or combination thereof, which deploy in the form of a sheet they may be planar or curved to facilitate use and removal.
  • the membrane can deflect tissue to enable transmission of energy out the spinal defect to be removed, or it can shield tissue on a front side of the membrane so that energy directed onto a spinal defect on a second side of the membrane does not damage the shielded tissue.
  • the membrane can protect the duramater from being damaged, and/or in can protect the thecal sac, for example.
  • the protective membrane can also be used to protect the duramater during the treatment of spinal stenosis using contralateral oblique approach to access the tissue to be removed by a minimally invasive surgical procedure involving percutaneous insertion of a tool between the laminae connected by the ligamentum flavum that is protruding into the spinal canal across the ventral interlaminar line (VILL).
  • VILL ventral interlaminar line
  • the protective membrane can be inserted in a direction from the base of the spine such as from the “tail bone opening” at the sacrum or from a non-treatment level to access the epidural space.
  • a wire or catheter having the protective membrane at the distal end or along a length thereof is inserted under fluoroscopic examination to precisely position the membrane into a position between the duramater and the ligament in the epidural space and provide radiological indication of the location of the epidural space and may also serve to protect the underlying duramater and nerves.
  • a surgical tool can then be inserted through the narrow opening between the spinous processes from the contralateral oblique axis to access the tissue to be removed and thereby decompress the spinal column.
  • the tool may be used to decompress the ligamentum flavum, central and medial part of the superior articular process as well as the inferior part of the intervertebral foramen.
  • Preferred embodiments can utilize visualization with a camera to view the surgical site using the surgical tool.
  • the protective membrane can be positioned from other access points as described herein.
  • surgery can be performed without the membrane where it is not feasible or critical to insert the membrane. Maintaining an angle of the contralateral oblique view of 35-45 degrees can enable safe placement of the tool at a contralateral oblique axis of 20-45 degrees from the opposite side starting behind the ventral interlaminar line.
  • the contralateral oblique view can present a very small opening to access the surgical site, it can be necessary to removal bone tissue, for example, to gain entry into the interlaminar space.
  • it can be essential to alter the axis of the surgical tool so as to deliver the cutting tool or other tissue removal instrument as described herein so as to remove the volume of tissue to decompress the spine.
  • a 3D image of the treatment segment may be utilized to plot the path of the tool from the skin to the spinal stenosis area to be removed, such as ligamentum flavum, superior articular process and the intervertebral foramen along the contralateral oblique axis of 20 degrees to 45 degrees.
  • two or more 2D (X-Ray) images of the treatment segment may be obtained at different projections.
  • Computer processor may then be used to analyze these images and then register these images upon the 3D image of the segment allowing the processor to identify the insertion point on the skin, and the tool trajectory on the 2D image, based upon the tool path previously plotted on the 3D image.
  • the tool may be advanced using intermittent fluoroscopy; two or more 2D images may be obtained intermittently and registered on the 3D image allowing the computer to depict the location of the tool on the 3D image. Based upon this information, adjustments may be made in trajectory as well as depth of the tool.
  • both the contralateral oblique view at 35-45 degrees and 3D projection of the tool may be used simultaneously to enhance safety and preventing the accidental advancement of the tool into the epidural space and the cental spinal canal.
  • a preferred embodiment uses an imaging device such as a CCD or CMOS digital imager to visualize the surgical region of interest.
  • the imaging device preferably has at least 50,000 pixels and preferably more than 1 million pixels for high resolution imaging at video frame rates. For embodiments employing a lower resolution camera, the number of pixels can be at least 30,000 or at least 10,000.
  • the imaging device can be mounted for positioning at the distal end of the device or a working channel within the device, or alternatively, can be optically coupled to a proximal end of a fiber optic imaging channel that can extend through the device or working channel to enable viewing of the region of interest.
  • Fig. 1 is an image depicting the structure of the human spine.
  • FIG. 2 schematically depicts the structure of an individual vertebra with the intervertebral disc on top.
  • FIG. 3 schematically depicts disc herniation.
  • FIG. 4 schematically depicts spinal stenosis.
  • FIG. 5 schematically depicts the caudal approach for epiduroscopy.
  • FIG. 6 schematically depicts the interlaminar approach for epiduroscopy.
  • FIG. 7 schematically depicts the transforaminal approach for epiduroscopy.
  • Fig. 8 schematically depicts the caudal, interlaminar, and transforaminal approaches for epiduroscopy.
  • Fig. 9 depicts a straight needle and a curved needle according to an embodiment.
  • Fig. 10 schematically depicts a wire according to multiple embodiments.
  • FIG. 11 schematically depicts a tip of an epiduroscope according to an embodiment.
  • Figs. 12A-12B schematically depicts unstowing and stowing of the tip of the epiduroscope according to an embodiment.
  • Figs. 13A-13B schematically depict unstowing and stowing of the tip of the epiduroscope when the tip is made of nitinol in an expanded shape according to an embodiment.
  • Figs. 14A and 14B schematically depicts unstowing and stowing of the tip of the epiduroscope when the tip is unstowed with a balloon according to an embodiment.
  • Fig. 15 schematically depicts unstowing and stowing of the tip of the epiduroscope when a stowable sheath is behind and external to the tip according to an embodiment.
  • FIG. 16A schematically depicts a balloon distally advanced over a herniated disc according to an embodiment.
  • FIG. 16B schematically depicts a balloon proximally advanced over a herniated disc according to an embodiment.
  • FIG. 17A schematically depicts an epiduroscope moving between a membrane and a spinal bone according to an embodiment.
  • Fig. 17B schematically depicts an epiduroscope approaching an intruding pathology according to an embodiment.
  • FIG. 17C schematically depicts an epiduroscope with a hinged member according to an embodiment.
  • Fig. 17D schematically depicts a laser, lenses, and a digital imager of an epiduroscope according to an embodiment.
  • FIG. 17E schematically illustrates a cross sectional view of the device depicted in Fig. 17D.
  • Fig. 17F schematically depicts a laser, lenses, and a fiber optic imaging channel of an epiduroscope according to an embodiment.
  • FIGs. 17G and 17H illustrate preferred embodiments of a tissue ablation device in accordance with preferred embodiments of the invention.
  • Fig. 171 illustrates an embodiment having a cooling fluid.
  • Figs. 17J and 17K illustrate an embodiment having a distal surface that is displaced in one direction along a device axis 1991 that is orthogonal to device axis 1997.
  • Fig. 18 depicts a method of removing an encroaching structure in an epidural space, according to an embodiment.
  • Fig. 19A illustrates a perspective view of a tubular body with one or more slits from the distal tip in accordance with various embodiments described herein.
  • Fig. 19B illustrates a perspective view of a tubular body with an open end design at the distal tip in accordance with various embodiments described herein.
  • FIGs. 22A and 22B illustrate cross-sectional views of a tubular body actuated by an inflatable member in the stowed and unstowed positions, respectively, in accordance with various embodiments described herein.
  • Fig. 23 illustrates a cross-sectional view of a tubular body with a thinned portion in the tube in accordance with various embodiments described herein.
  • Fig. 24 illustrates a cross-sectional view of a tubular body with a tube composed of two materials with dissimilar stiffness in accordance with various embodiments described herein.
  • Figs. 25A and 25B illustrate longitudinal and transverse views, respectively, of a portion of a spine having a stenosis.
  • Figs. 26A and 26B illustrate longitudinal and transverse views, respectively, of placement of a catheter in the epidural space between the ligamentum flavum and the spinal canal in accordance with various embodiments described herein.
  • FIGs. 27A and 27B illustrate longitudinal and transverse views, respectively, of retraction of an outer sheath of the catheter and insertion of a tubular body using an outside approach in accordance with various embodiments described herein.
  • Figs. 28A and 28B illustrate longitudinal and transverse views, respectively, of ablation of a portion of the ligamentum flavum using an energy source in accordance with various embodiments described herein.
  • Figs. 31 A and 3 IB illustrate longitudinal and transverse views, respectively, of placement of the portion of the spine with alleviated stenosis.
  • Fig. 32 illustrates anatomical measurements on a radiographic image to aid in determination of the appropriate shield size in accordance with various embodiments.
  • Figs. 33A and 33B show cross-sectional views of an external scope before and after dilation of the distal tip, respectively.
  • Figs. 34A-34C illustrate progressive stages of deployment of a shield from a catheter in accordance with embodiments described herein.
  • FIGs. 35A-35B illustrate deployment of a shield having a membrane and tines in accordance with embodiments described herein.
  • Figs. 36-38 illustrate transverse views of steps of a procedure for spinal decompression using a contralateral approach.
  • Fig. 36 illustrates placement of a shield between the spinal column and the ligamentum flavum.
  • Fig. 37 illustrates contralateral introduction of a decompression tool.
  • Fig 38 illustrates initial stages of removal of ligamentum flavum as the decompression tool is advanced.
  • Fig. 39A illustrates further insertion of the decompression tool and additional removal of ligamentum flavum all the way to the vertebral body.
  • Fig. 39B illustrates a system for collinear imaging from a contralateral view combined with contralateral insertion of a decompression tool.
  • Figs. 39C1-C5, 39D1-D5, 39E1-E3, 39F1-F4, and 39G1-G3 illustrate preferred examples of methods for decompression of the epidural space.
  • Fig. 39H1 schematically illustrates imaging along a first axis wherein the imaging axis extends along or substantially parallel to the insertion axis of a decompression tool along a contralateral oblique axis for viewing of the tool entry into the epidural space.
  • Fig. 39H2 schematically illustrates imaging along a second axis such as the anterior-posterior (AP) view of the spinal region to image insertion of a decompression tool along a contralateral oblique axis into the epidural space.
  • AP anterior-posterior
  • Fig. 39H3 illustrates an exemplary extracting tool for removal of tissue from within the epidural space of a spinal region with an attached rotational geared cap.
  • Fig. 39H4 illustrates an exemplary tubular body of the extracting tool having a distal circular cutting edge.
  • Fig. 39H5 is an exploded view of the distal end of the cannula wherein the geared cap of the cannula can engage teeth of a rotating drive coupler actuated by a handle motor to drive rotation of the cannula or the extracting tool cutting edge.
  • Fig, 39H6 illustrates the stylet used to open the channel through any intervening bone and tissue to gain access to the epidural space.
  • Fig. 39H7 illustrates and exploded detailed view of an exemplary tool positioning assembly.
  • Fig. 39H8 illustrates a detailed view of the distal cutting element of an extractor for removing tissue from the epidural space.
  • Fig. 39H9 illustrates a side view of the handle assembly with the stylet mounted therein for placement into the spinal region to form an access channel for insertion of the extractor.
  • Fig. 39H10 illustrates the placement of the extractor into the handle assembly for delivery of the cutting element into the epidural space through the access channel.
  • Fig. 39H11 illustrates a stylet having a fluid delivery channel that is coupled to a pump or syringe for delivery of fluids such as a local anesthetic into the spinal region during surgery.
  • Figs. 39H12a and 39H12b illustrates a process sequence for imaging of a procedure for guiding delivery of a decompression tool as described herein into the epidural space wherein a plurality of views are registered to guide tool placement relative to a displayed path on a 3D image of the spinal region.
  • Fig. 40 illustrates placement of the shield on the opposite lateral side and removal of ligamentum flavum by opposite contralateral insertion of the decompression tool.
  • Fig. 41 illustrates the expansion of the now decompressed epidural column into space vacated by the ligamentum flavum after the procedure is concluded.
  • Fig. 42 illustrates an x-ray image taken from the contralateral oblique (CLO) view.
  • Fig. 43 illustrates an x-ray image in the CLO view highlighting the laminae and the ventral margin of the laminae.
  • Fig. 44 illustrates an x-ray image in the CLO view showing the relationship between normal ligamentum flavum and the ventral interlaminar line (VILL).
  • Fig. 45 illustrates an x-ray image in the CLO view showing the relationship between abnormal ligamentum flavum and the VILL.
  • Fig. 46 illustrates an x-ray image in the CLO view showing a radiopaque shield inserted into the epidural space against the ventral edge of the ligamentum.
  • Fig. 47 illustrates an x-ray image in the CLO view illustrating the portion of the ligamentum that can safely be debulked even in the absence of a shield.
  • Fig. 48 illustrates an x-ray image in the CLO view illustrating the point of insertion of an introducer tool from the contralateral side.
  • Fig. 49 illustrates an x-ray image in the CLO view showing advancement of the introducer tool.
  • Fig. 50 illustrates an x-ray image in the antero-posterior projection view of the same region shown in Fig. 49.
  • Fig. 51 illustrates an x-ray image in the AP view showing advancement of the decompression tool in multiple superior and inferior planes.
  • Fig. 52 illustrates a transverse view of advancement of the introducer tool or decompression tool from the contralateral side at an angle with respect to the midline.
  • the basic structural unit of the spine is a vertebra. There are 7 individual vertebrae in the neck, 12 individual vertebrae in the upper and mid back (thoracic vertebra), and five individual vertebra in the lower back (lumbar vertebra) in the human spinal column. There are nine fused vertebrae below the lumbar vertebrae, namely, the sacrum (5 fused vertebrae), and the tail bone (4 fused vertebrae). The individual vertebrae are joined to each other in the front and the back.
  • the structure of the human spine is shown in Fig 1 and the structure of an individual vertebra with the intervertebral disc on top is shown in Fig. 2.
  • the spine has 33 vertebrae (7 cervical, 12 thoracic, 5 lumbar, 5 sacral, 4 coccygeal).
  • Preferred embodiments of an endoscopic device can be advanced into all areas of the spinal canal and may be introduced from below, via the tail bone opening 11 (sacrococcygeal hiatus), or the back, the interlaminar opening 12, or the side, the transforaminal opening 13.
  • the device is flexible and preferably has a diameter of less than 5 mm in diameter.
  • the cross sectional shape can be substantially circular, oval, rectangular, ellipsoidal or a non-uniform ellipse shape, depending upon the location of percutaneous entry.
  • the cross-sectional area of the device is less than 20 mm 2 , is preferably less than 14 mm 2 , and to further reduce the risk of perforation of damage to the epidural membrane surrounding features is less than 10 mm 2 .
  • the intervertebral disc is a cushion like structure in between the vertebrae that accommodates motion and absorbs shock as shown in Fig. 2 which schematically depicts a cross section of the spine.
  • the intervertebral disc 20 is consequently a cushion between the vertebrae that enables freedom of movement while preserving the structure.
  • the spinal canal 21 In the middle of the vertebra there is an opening or a hole, in the spinal canal 21. Inside the spinal canal 21 a fluid filled sac is positioned, the thecal sac 22. Inside the thecal sac 22 lie the nerves 23 and the spinal cord. The fluid in the thecal sac 23 is enclosed in a soft membrane, the duramater 24, which can be easily deformed.
  • the space between the duramater 24 and the bone of the vertebra is the epidural space 25.
  • the epidural space 25 ends at the upper end of the spine and below at the base of the sacrum. Since the duramater 24 can be deformed, the epidural space 25 size may be increased manually by pushing with a mechanical device such as a balloon. The space created cannot, however, be sustained after the distending force dissipates given the outward force exerted on the duramater 24 by the fluid in the thecal sac 22.
  • the spinal canal 21 is a conduit for the spinal cord and the nerves 23.
  • the margins of the spinal canal 21 are formed by the vertebral body or the disc in the front. In the back the margin is formed by the bony laminae 26 that are joined together by the ligamentum flavum 27. In the back the vertebra are attached to each other through several ligaments and joints. The ligamentum flavum 27 also connects the vertebrae in the back.
  • the intervertebral disc 20 is composed of a central soft gelatinous material in the center, the nucleus 38, which is enclosed in tough circumferential fibro cartilage, the disc annulus 39. With wear and tear, the disc annulus 39 may at times rupture allowing the disc to herniate or displace itself into the canal 31.
  • Fig. 3 schematically depicts a disc herniation 30 that extends out of the disc center. The herniated disc 30 material creates severe pain because of irritation as well as pressure on the nerves and spinal cord that get impinged against the bony canal.
  • Fig. 4 schematically depicts an example of spinal stenosis.
  • the cause of spinal stenosis is ligament tissue 40 overgrowth. It is clear from this figure that to remove the stenosis the overlying tissue 40 will need to be removed surgically. However there is another option of threading a laser device to the area and removing the overgrown tissue 40 and bone as necessary by vaporizing it. The small amount of debris can be absorbed by the body.
  • the innovation in this device specifically pertains to access of the stenotic area, visualization of the region and safe ablation of the tissue 40.
  • a further advantage of devices and methods described herein is to access the overgrown tissue from outside without entering the epidural space, by directly debulking the ligament and bone, either mechanically, or using various other tissue removal devices described herein [00100]
  • Various invasive surgical methods are used when there is encroachment upon the spinal canal.
  • a disc herniation a discectomy can be done.
  • the disc and some overlying bone and tissue are removed.
  • additional screws and plates may also be placed to fuse the bones and maintain stability of the spine.
  • removal of a disc can also be done endoscopically through a rigid tube greater than 5 mm in diameter. Epidural scopes that are smaller than 5 mm can be used for ablation of a disc, however, poor visualization has prevented such procedures.
  • bony overgrowth of the superior articular process and narrowing of the intervertebral foramen can also cause stenosis requiring removal of the superior articular process, by facetectomy as well as shaving the margin of the foramen to make it larger, known as foraminotomy procedure.
  • Removing a part of the lamina via laminectomy is also a common procedure for spinal stenosis. Removal of significant material can lead to instability requiring a screw and rod fixation of the segment.
  • Minimally invasive lumbar decompression involves manual removal of ligamentum flavum under X-Ray visualization with rigid instruments, but is done without direct visualization.
  • the epidural space and epiduroscopy may be performed by the sacral hiatus approach.
  • Wire 50A is directed into the neural foramen for this method.
  • Wire 50B can be directed posteriorly in the epidural space for the approach for ligamentum flavum resection for treatment of spinal stenosis.
  • Wire 50C can be directed into the front and this approach is appropriate for removal of a herniated disc.
  • a needle is first inserted into the sacral hiatus at the opening at the bottom of the spine.
  • the epidural space can be identified by loss of resistance technique.
  • a wire can then be threaded into the epidural space.
  • a curved wire is preferred to aid in navigation to the desired location.
  • the semi-rigid wire (0.5 mm-2 mm in diameter) is slowly advanced by gentle direct force.
  • the tip is directed to reach the correct compartment of the epidural space.
  • the access device or a working channel of the epiduroscope or tubular visualization device may be then threaded over the wire to reach the area of pathology.
  • the wire may expand by inflating like a balloon to dilate the track.
  • dilators of different sizes may also be used sequentially to thread over the wire to create space for the access device or epiduroscope.
  • the dilators are made of plastic or metal with variable rigidity and diameter. These may be threaded over the wire in a sequential fashion to create space for the epiduroscope, for example, when difficulty arises in threading the epiduroscope.
  • a probe with a working channel can be placed initially instead of the scope. Once it is threaded over the wire to the correct location the epiduroscope can slide into position within the working channel for example.
  • the diameter of the working channel can be such as to accommodate the access device or epiduroscope within it.
  • the probe with the working channel can be flexible or semirigid with a soft rounded tip formed by a stylet placed within it.
  • the soft rounded distal tip may be soft or semi rigid and can be shaped to facilitate displacement of the epidural membrane for a specific application.
  • the tip of the stylet may be inflatable to dilate the tract, or distal region, within the epidural space when needed.
  • the stylet can thus be used to initially deflect the membrane adjacent to the structure to be ablated and thereby enable visualization and treatment. As the distal end of the stylet is retracted into the working channel, the distal tip of the working channel can be translated to maintain separation of the membrane from the adjoining structure.
  • the access device has individual lumens for imaging, laser light delivery, illumination, suction, coolant flow, fluid delivery and components may be placed in lumens individually as needed during a surgical procedure.
  • the epidural space may be accessed with a needle placed in the interlaminar space and thus enters between the bones, referred to herein as “the interlaminar approach” as depicted in Fig 6.
  • the wire is inserted into the epidural space from the back. It may then be advanced in the posterior compartment 61 of the epidural space (appropriate approach for spinal stenosis), or in the anterior compartment 62 (appropriate approach for disc herniation).
  • the dotted line is the duramater 60D, the shaded area is the hypertrophied ligament 60LFN and the needle is represented by letter 60N.
  • the epidural space can be reached by threading a needle from the back.
  • the needle may be straight or curved.
  • the epidural space is identified by loss of resistance technique.
  • a wire may then be threaded into the epidural space.
  • a curved wire is preferred to facilitate proper guidance.
  • the semi-rigid wire (0.5-2 mm in diameter) is slowly advanced by gentle direct force.
  • the tip is directed to reach the correct compartment of the epidural space.
  • the tip may be directed towards the head or the foot based upon where the narrowed area to be treated is located.
  • the device or the epiduroscope can then be threaded over the wire to reach the area of pathology.
  • the wire may expand by inflating like a balloon to dilate the track.
  • dilators of different sizes may also be used sequentially to thread over the wire to create space for the device.
  • a needle may be placed directly in the epidural space through this opening, the “transforaminal approach” as depicted in Fig. 7 which is a view from the back of the spine.
  • the curved needle 70N is placed into the foramen from the side and the wire 70W (thick line) is advanced into the posterior epidural space 71, appropriate for ligamentum decompression or the anterior epidural space, dotted line 72 appropriate for disc herniation or the foramen, and the lateral epidural space 73 appropriate for disc herniation and foraminal decompression.
  • a curved needle is placed into the side opening in the spine where the nerves emerge known as the intervertebral foramen.
  • a wire is threaded into the epidural space. Needle adjustment may be needed until the wire can be threaded. A wire may then be threaded into the epidural space.
  • a curved wire is optimal.
  • the semi-rigid wire (1-2 mm in diameter) is slowly advanced by gentle direct force.
  • the tip is directed to reach the correct compartment of the epidural space.
  • the tip may be directed towards the head or the foot based upon where the narrowed area to be treated is located.
  • the device or a working channel may be then threaded over the wire to reach the area of pathology.
  • the wire may expand by inflating like a balloon to dilate the track.
  • Fig. 8 schematically depicts various methods of entering the epidural space superimposed over a spine model.
  • 81 represents sacral hiatus insertion
  • 82 represents sacral hiatus to foramen
  • 83 represents sacral hiatus to epidural space
  • 84 represents transforaminal approach to epidural space
  • 85 represents an interlaminar approach
  • 86 is a diagram of an epiduroscope in the dorsal epidural space reflecting the duramater.
  • the present invention is described and made to deliver a flexible device by the interlaminar, transforaminal, or sacral route to the area of encroaching pathology in conditions such as spinal stenosis and disc herniation.
  • the instruments and methods for accessing the area of pathology, for visualizing the pathology, protection of vulnerable tissue and removal of the pathology of concern are described in greater detail.
  • the devices enable minimally invasive surgery of the spine by solving the problems of visualization and safety while also realizing effective decompression.
  • the present invention is designed to access the area of pathology in all areas of the spine, including the back and the neck.
  • the device may be placed into the epidural space using interlaminar (back), caudal (tail bone) or transforaminal (side) approach at any level of the lumbar, thoracic and cervical spine.
  • the device may be advanced in the anterior (front) or lateral (side) or epidural posterior (back) epidural space for pathology such as disc herniation or spinal stenosis.
  • the epidural space may be accessed with a straight or curved needle or cannula by the interlaminar, transforaminal, or sacral route.
  • Fig. 9 schematically depicts a straight needle 90 and a curved needle 95 according to an embodiment.
  • Metallic needles may be used.
  • the needles can be hollow to enable introduction of flexible tubular bodies.
  • a wire may then be threaded through the needle tip.
  • Fig. 10 schematically depicts a wire according to multiple embodiments.
  • Wires 100A-C represent straight wire.
  • Wires 100D-F represent curved wires pre-bent or with a hollow core in which a curved stylet may be placed and appropriately curved.
  • Wires 100G-I represent wires in which the curvature may be increased or decreased using a plurality of joints.
  • Wires 100A, 100D, 100G have no dilation tools.
  • Wires 100B, 100E, and 100H have a dilation tool at the tip such as an inflatable balloon tip or a balloon may be advanced through the wire core and inflated at the tip.
  • the tip may be wrapped in an inflatable membrane that can be inflated from outside.
  • the entire wire or portions of thereof may be inflatable aiding the dilation of the space for allowing an epiduroscope or access device to pass.
  • the wire may be wrapped in an inflatable membrane that can be inflated from outside.
  • the membrane may have compartments allowing for segmental inflation.
  • the wire may be solid or with hollow core.
  • the wire may have straight or curved tip.
  • the curved wire can assist in controlling wire tip motion.
  • the curve may be attained by using a curved stylet or a pre-bent wire. By using the curve the wire may be advanced into the intended area under X-Ray visualization or other methods of control such as ultrasound, or other neuro-navigation tools.
  • the wires range from 0.5 -2 mm, may be hollow or solid, and are made from metal or plastic. Curved wires may have a pre-bent tip or a hollow core into which a curved stylet may then be introduced. The wire may also have an adjustable curve, via a plurality of joints to allow for precise navigation in the epidural space.
  • the epidural wires may also have an inflatable balloon tip to allow for creation of space when there is difficulty in navigation and to avoid puncturing the dura.
  • the tip itself may be covered by an inflatable membrane or a balloon that can be introduced through the hollow core for this purpose.
  • the entire wire or parts of the wire may be covered by an inflatable membrane to allow for dilation of the epidural space and for easy passage of the epiduroscope or the access device.
  • Fig. 11 schematically depicts a tip of a working channel device or epiduroscope 1100 according to preferred embodiments.
  • the access device can comprise an epiduroscope or a combination with other components as described herein.
  • the wire tip curvature 1102 may be variable and controlled by the operator for greater precision. The curvature may be modulated by employing a plurality of joints.
  • the device tip can have a balloon to distend the area if unable to navigate.
  • device tip can have a stylet to form smooth passage for the device.
  • a balloon or membrane can be inflated to distend the passage to enable visualization.
  • the tip 1104 of the working channel device may be rotated or bent in different planes using wires that lie in the body of scope and are attached to the tip. The membrane can also serve to deflect tissue away from the surgical region and thereby prevent damage during therapy.
  • the sub 5 mm device with a stowed expandable tip may then be advanced over the wire.
  • the device tip can be non-expandable.
  • the tip of the device may be moved in 1 or 2 or multiple planes employing a plurality of joints.
  • the tip of the device has metallic strips interspersed with transparent plastic.
  • Fig. 12A schematically depicts unstowing and stowing of the tip of the device according to an embodiment.
  • the tip of the device is covered circumferentially by a sleeve at the tip only or a circumferential outer tube throughout the length of the scope.
  • the sleeve or the outer tube is withdrawn to allow deploying of the tip.
  • the tip of the device can be unstowed by using a plurality of joints.
  • the tip may be again stowed by advancing the outer tube or sleeve back over it.
  • the tip is covered by a sleeve 1201 that may extend the entire length of the device or just at the tip 1200A.
  • the inner tube tip is in a stowed position.
  • the outer sleeve is withdrawn using a trigger or other actuation mechanism in the handle of the scope 1200B.
  • the tip may then be unstowed or dispensed for use. In this particular instance the tip is unstowed by tugging on the wires 1202 attached to the tip 1200C.
  • Note that only the dural half of the tip can be moveable. This is accomplished by pulling a lever in the handle.
  • the tip may be unfurled into a spherical configuration 1200S or more of a rectangular configuration 1200R as seen in Fig. 12B.
  • the tip can be beveled (or not beveled) and the longer edge is optionally color coded red, for example.
  • the device tip can be non-beveled and the dural edge, that is, the tip portion that engages and moves the durameter can be identified with a radio-opaque marker.
  • the forward facing laser beam is centered at a point that can be (or not be) offset towards the receding edge.
  • Other portions of the tip can also be radio-opaque to provide for appropriate recognition under fluoroscopy.
  • the outer tube or sleeve maybe advanced back over the tip to stow it and the scope navigated into another area as needed.
  • only a portion of the distal circumference serves to displace the membrane to form a three dimensional visualization and ablation space.
  • the various embodiments herein can incorporate this feature.
  • the base of the access device or epiduroscope can be enclosed or covered with an inflatable membrane to enable controlled movement in the anterior posterior plane.
  • Fig. 13A schematically depicts unstowing and stowing of the tip 1300A-1300D analogous to 1200A-1200D of the epiduroscope when the tip 1300C is made of nitinol in an expanded shape according to an embodiment.
  • the tip is made of metal strips such as nitinol in an expanded shape.
  • This is kept stowed by the outer tube which can be moved back and forth to enable rapid stowing and unstowing.
  • the inner stowed tip unfurls or moves into the preformed shape.
  • Fig. 13B in circular 13008 rectangular I 300R or other shape described herein.
  • the outer sleeve or tube slides back on and the tip is again stowed allowing for further endoscope motion.
  • Fig. 14A schematically depicts unstowing and stowing of the tip of the device when the tip is unstowed with a balloon according to an embodiment.
  • the tip 1400C of the epiduroscope may be unstowed by deploying a balloon 1410 that is inserted through the working channel.
  • the tip may be again stowed by advancing the outer tube or sleeve back over it.
  • the metal strips or wires in the tip prevent spontaneous collapse.
  • the sleeve or outer tube 1402 may be moved backwards and forwards using a lever at the proximal end and thus accomplishing opening and closing of the unstowed tip.
  • the scope can be mobilized in the epidural space again.
  • the shape of the deployed structure is illustrated in Fig. 14B.
  • Fig. 15 schematically depicts unstowing and stowing of the tip 1500C of the device when a stowable sheath 1502 is behind and external to the tip according to an embodiment.
  • the stowable sheath 1502 is behind and external to the distal end of the scope.
  • the distal edge of the outer tube overlies the proximal edge of the inner tube.
  • As the inner tube is withdrawn it flays metal strips 1504 on the outer tube creating a funnel or rectangular shaped shield that displaces the dura mater allowing greater visualization through the inner tube.
  • the inner tube is pushed distally collapsing the shield.
  • the tip maintains shape from natural plasticity of inserted metallic strips.
  • the scope has a proximal and distal end.
  • the proximal end can have a lever allowing motion of the tip through inbuilt control wires that extend along the length of the tubular scope.
  • the handle has an intake for the light source, video output from the CMOS or CCD sensor, or fiber optic channel, a port for a laser, and two working channels.
  • the laser channel is adaptable to all lasers suitable for the ablation procedure (e.g., Nd: YAG or Ho: YAG) but a preferred embodiment utilizes CO2 laser delivery.
  • Such lasers can operate at a wavelength of 10,600 nm and have output powers in a range of 40-100 watts that can be operated in a pulsed mode using pulse width modulation.
  • the scope may be of variable length based upon the particular application such as whether to be used in the back or the neck. In some embodiments, the scope has a width of approximately in a range of 3-7 mm, and preferably at about 5 mm or less.
  • the tubular body can possess varying degrees of flexibility.
  • the body can be a double tube or a single tube with a coaxial external tip at the distal end.
  • the outer tube the distal tip can be retractable to deploy and stow the expandable tip.
  • the handle has levers for mobility of the distal tip in one or more planes.
  • a balloon can be advanced through the working channel and inflated at the tip to allow for smooth distal tip to allow navigation and decrease risk of dural puncture.
  • the expandable tip is activated by wires there is a lever for stowing and retracting the tip as well as a lever for sliding the sleeve or the outer tube.
  • the expandable tip is composed of a material with metal memory such as nitinol
  • the balloon can slide through the working channel and expand the tip.
  • a lever retracts the outer tube.
  • the outer tube can slide back over the expanded tip to be stowed.
  • the outer tube or the distal tip can have a hinged end such that pulling the inner tube deploys the outer tube or outer distal tip to allow visualization in this manner.
  • the stowable tip is slightly oblong with the longer side color coded and directed to the dura mater. At the distal end of the tip is the laser beam aperture, two working channels and a camera sensor. The forward facing laser can be directed slightly off center towards the closer portion of the target material.
  • only the access channel device is initially introduced. It has the stowable tip that can be deployed using any of the methods described above. Once it is deployed the device with a laser emission port, one or two working channels, and a camera can then be introduced to reach the distal end of the stowable tip of the working channel.
  • the epiduroscope or access device can be semi-rigid or rigid with a flexible tip.
  • the access device or the cannula and stowable tip can be tubular structure or have of a substantially rectangular or ellipsoid cross section or profile.
  • a wire with an inflatable hood may be advanced through the working channel and advanced over the intruding pathology providing a safety wall to the spinal sac distally.
  • a color shield or balloon may be introduced from the opposite side to provide a barrier and an end point to the firing laser.
  • the distance of the laser tip from the pathology is radiologically and visually ascertained.
  • a measuring tool such as a rigid wire or rod can be advanced from the distal tip to contact the pathology or tissue/material to be removed.
  • This can include a sensor that indicates the distance to the target region, computes and indicates the spot size and communicates the power requirements and can automatically set the illumination parameters.
  • the laser can be operated in a continuous mode, a pulsed mode, or super pulsed mode. When the disc is at an optimal distance from the pathology and the safe side of the cannula is placed toward the bone the CO2 laser is fired.
  • the laser emission is adjusted based upon radiological measures so that damage is restricted to the target and not beyond.
  • the laser is fired under continuous visual monitoring.
  • the tip is stowed and the cannula moved slowly as and when needed. Saline flush or other fluid or gas flow can optionally be used for removal of the vaporized tissue.
  • the ablation process continues until all the area of pathology is ablated visually as well as determining the status radiologically by x-ray, ultrasound, or computed tomography (CT) imaging procedures.
  • CT computed tomography
  • a wire can also be extended to form the distal tip for distance measurement.
  • Fig. 16A schematically depicts a balloon 1600A distally advanced over a herniated disc according to an embodiment. This provides a distal shield as well as indicator for procedure completion.
  • Fig. 16B schematically depicts a balloon 1600B proximally advanced over a herniated disc according to an embodiment.
  • Fig. 17A schematically depicts a stylet for introducing an epiduroscope 1700 moving in an epidural space between a membrane and a spine according to an embodiment.
  • the epiduroscope comprises a working channel 1710.
  • the working channel 1710 is shaped to smoothly move under membranous tissue without tearing the membrane. Additionally, the shape of the working channel 1710 allows for extension and withdrawal of the stylet 1720 without inhibiting the movement of the stylet 1720.
  • the distal tip of the stylet 1720 is marked, dyed, coated, or otherwise manufactured to be visible via x-ray, fluoroscopy, or other diagnostic tool. In some embodiments, the distal tip may be fluorescent.
  • the distal tip of the stylet 1720 is a domed, blunt nose that deflects the membrane around the sides of the tubular body of the stylet 1720.
  • the distal tip of the stylet can include an inflatable device or membrane to gently form a cavity in case of an obstruction, scar tissue, or adhesions.
  • Fig, 17B schematically depicts an epiduroscope 1700 approaching an intruding pathology according to an embodiment.
  • the stylet 1720 can be withdrawn.
  • the stylet 1720 is withdrawn by twisting the stylet 1720 and pulling the stylet 1720 away from the pathology.
  • a laser 1730 is then positioned at a predetermined position 1735 within the working channel 1710. Specifically, the laser 1730 is positioned in a position 1735 at a distance from the pathology wherein the laser 1730 is able to ablate the pathology.
  • Fig. 17C schematically depicts an epiduroscope 1700 with a moving member attached to a distal end such as a hinged member 1715 according to an embodiment.
  • a hinged member 1715 on the distal end of the working channel 1710 moves forward to maintain an opening to view and treat the surgical site.
  • the hinged member 1715 maintains an opening for the laser 1730 to ablate the intruding pathology.
  • the member 1715 can also extend to the opposite side of the material 30 such that the light that is used to ablate tissue 30 does not fully penetrate and thereby damage the epidural membrane.
  • a second probe can be percutaneously inserted from a different location on the opposite side of tissue 30 that is positioned to absorb or reflect light from the laser that would otherwise be directed onto the inner surface of the membrane or other adjacent tissue.
  • the devices described herein can include handle enabling manual manipulation and actuation of electronic components.
  • the handle 1780 can be connected to computer 1782, image display 1784, and data storage 1786 devices.
  • the handle 1780 can have manual actuators 1790 to trigger the laser that is located in the handle or in an external laser light source such as CO2 laser 1792 which can be coupled into the handle by rigid waveguides, flexible hollow fiber as described herein or free space lens assembly, imaging devices, LED illumination, target illumination, and distance measuring element.
  • the handle can include imaging sensors coupled to fiber optics, light sources for illumination, and a control processor connectable to an external computer and network.
  • Figs. 17D-17G depict embodiments that can be inserted into the working channel of Fig. 17A or can be used as integral units having the dilating elements described generally herein.
  • Fig. 17D schematically depicts a distal end of a preferred epiduroscope including an optical fiber or bundle of optical fibers 1730 to deliver light onto an area 1734 of tissue 1702 to be removed.
  • the lenses 1740, aperture stop 1745 and a digital imager 1750 of the epiduroscope 1700 enable visualization of the tissue 1702. After withdrawing the stylet 1720, for example, the tissue visualization and ablation device is inserted through the working channel 1710.
  • the surgeon first illuminates the tissue to visually identify the area to be ablated and positions the device to direct a beam of light onto a spot 1734 of a tissue surface.
  • the lenses 1740 receive light from the field of view, including the tissue 1702 to be removed.
  • the resulting image is detected by the digital imager 1750.
  • the digital imager 1750 is a CMOS sensor.
  • the digital imager 1750 is a charge- coupled device (CCD).
  • the digital imager 1750 preferably has at least 50,000 pixels and preferably 300,000 pixels for high resolution imaging at video frame rates. For embodiments employing a lower resolution camera, the number of pixels in the digital imager 1750 can be at least 30,000 or at least 10,000.
  • the digital imager 1750 transmits a digital image data to a computer for processing and display.
  • the imaging device can include a processor 1752 that processes the image data and transmits the data through conductive connector or wire to the proximal end of the endoscope.
  • the distal ends of the fibers or the LEDs 1752 can be arranged in an annular array within the tubular body 1747 to more evenly illuminate the field of view.
  • the imaging aperture 1738 and the light emission aperture 1736 for the removal of tissue are preferably aligned upon a central axis of the tubular body 1700.
  • the field of view can be illuminated by one or more light emitters 1752 which can be optical fibers, optical fiber bundles or light emitting diodes (LEDs) mounted at the distal end of the endoscope.
  • the visualization and ablation device can optionally include a suction channel 1746, a fluid delivery channel 1748, an instrument channel, or a balloon sheath.
  • Fig. 17F schematically depicts an optical fiber 1830 to deliver light for ablation of tissue in which, lenses 1880, evenly distribute the light onto tissue 1802.
  • a fiber optic imaging channel 1860 of an epiduroscope couples the image to an image sensor at the proximal end.
  • the lenses 1840 can be optically coupled to a distal end of a fiber optic imaging channel that can extend through the working channel 1710 to enable viewing of the region of interest.
  • the fiber optic imaging channel 1860 preferably has at least 300,000 pixels, and preferably more than 1 million pixels for high resolution imaging at video frame rates.
  • the fiber optic imaging channel 1860 transmits the image that is delivered to a detector which generates digital image data to a computer for processing and display.
  • the digital imager 1750 or the fiber optic imaging channel 1860 can be mounted within a second tubular body in which a laser light delivery system can also be mounted such that the digital imager 1750 or the fiber optic imaging channel 1860 and related optical elements are arranged to view the illuminated region of tissue.
  • a second white light source such as a light emitting device (LED) can be used to provide illumination of the small surgical field of view.
  • Preferred embodiments of the invention relate to the use of light sources emitting at wavelengths that will ablate or vaporize tissue to be removed from a surgical site for treatment of spinal injury or conditions that impair movement and/or cause pain.
  • a CO2 laser can be used to emit a beam of light that is coupled into a waveguide of an endoscope or epiduroscope for delivery to a location within the epidural space.
  • a probe body 1920 has been inserted into the epidural space.
  • the body 1920 can be a flexible tubular member that is inserted into the epidural space using procedure described in the present application.
  • Light from a CO2 laser is coupled into waveguide 1907 to couple light into distal beam shaping element 1902 waveguide 1907 can be flexible and use silica and silver layers such as those available from Laser Engineering Inc. in Milford, MA.
  • An optical fiber 1904 can be used to illuminate the spot that is to be ablated by the light emitted from element 1902.
  • a hard ceramic can be used at the distal tip of the waveguide. Fluid aspiration can be used to clean the tip during the procedure.
  • the spot generated by optical fiber 1904 is pre-aligned with the spot illuminated by element 1902 so that a user can see the tissue region to be ablated by one or more laser pulses emitted from the distal aperture of element 1902.
  • Visualization channel 1906 is positioned for viewing tissue to be ablated at a distance from the distal end of the device.
  • Annular light emitting elements 1908 are used to illuminate the entire field of view to enable steering of the targeting light spot provided by fiber 1904.
  • a beam of visible light can also be coupled into channel 1905 of waveguide 1907 using a mirror and a further LED light source.
  • Fig. 17H shows a second beam shaping element 1952 that projects a spot having a different size onto the defect to be treated.
  • the emission aperture can be open and can use a fluid such as a gas flow to maintain the waveguide free of body fluids or debris.
  • the emission aperture can be covered or enclosed with a light transmissive cap or window at the wavelengths of the CO2 laser.
  • a probe element 1955 can be extended distally to contact material to be ablated and thereby determine a distance 1957 from a distal end of the device in the present and previously described embodiments. This distance can be used to automatically compute ablation laser parameters based on spot size.
  • a coolant can be introduced into the catheter or endoscope body 1980 where fluid is directed through port 1984 into one or more channels within the tubular body towards the distal end where in passes along a distal channel 1982 and reverses direction to exit port 1986.
  • This embodiment can be used for application using continuous wave or longer pulse duration applications to ablate material for certain applications.
  • Figs. 17J and 17K illustrate cross-sectional views of an embodiment having a first curved side 1990 that expands to a larger diameter 1998 to move the epidural membrane and thereby form the visualization and ablation of cavity.
  • Fig. 18 depicts a method of removing an encroaching structure in an epidural space, according to an embodiment.
  • the method begins when an epidural space is identified (Step 1810).
  • the epidural space can be identified by loss of resistance technique.
  • a wire is advanced into an epidural space (Step 1820).
  • a curved wire is preferred to aid in navigation to the desired location.
  • the wire may be semi-rigid (0.5-2 mm) and is slowly advanced by gentle direct force.
  • the tip of the wire is then directed to reach the correct compartment (Step 1830).
  • a working channel is threaded over the wire (Step 1840). Once the working channel is threaded over the wire to the correct location an epiduroscope is slid into position within the working channel (Step 1850). If necessary, the compartment is dilated (Step 1860). Dilators of different sizes may also be used sequentially to thread over the wire to create space for the epiduroscope.
  • the dilators are made of plastic or metal with variable rigidity and diameter. These may be threaded over the wire in a sequential fashion to create space for the epiduroscope when difficulty arises in threading the epiduroscope.
  • intruding pathology is ablated with a laser (Step 1870).
  • the laser may be a CO2 laser.
  • a wire with an inflatable hood may be advanced through the working channel and advanced over the intruding pathology providing a safety wall to the spinal sac distally.
  • a color shield or balloon may be introduced from the opposite side to provide a barrier and an end point to the firing laser.
  • alternative energy sources such as quantum molecular resonance, coblation, heat, or ultrasonic energy may also be used to ablate the tissue. In such cases, it may be desirable to advance the energy source under direct vision to contact the tissue to be ablated.
  • Fig. 19A illustrates a perspective view of a tubular body 2001 with one or more slits 2010 from the distal tip in accordance with various embodiments described herein.
  • the distal tip of the tubular body is split into a first section 2002 and, optionally, a second section 2003 that can bend independently of one another and, more particularly, away from a longitudinal axis of the tubular body 2001 or one other.
  • through holes 2013 are placed on opposite sides of the tubular body 2001.
  • the though hole 2013 can be formed by boring, coring, or drilling through the tubular body 2001.
  • the tubular body 2001, 2001’ or a portion thereof can be formed of a plastic or shape memory material such as nitinol.
  • the first section 2002, 2002’ and the second section 2003, 2003’ can be color-coded (e.g., different colors are used for different sections to allow visual identification.
  • the first section 2002, 2002’ and the second section 2003, 2003’ can be radiopaque in some embodiments.
  • a length of the first section 2002, 2002’ can be longer than a length of the second section 2003, 2003’ to allow the sections to be distinguished in, e.g., x-ray images and can also aid in selecting a direction for the illuminating beam or viewing angle.
  • the wire 2015 is embedded in the wall of the tubular body 2001, 2001’ throughout to the tip and motion of the first section 2002, 2002’ and/or second section 2003, 2003’ occurs by pulling the wire taut causing the hinge point to give out and flexing the sections outward.
  • the wire 2015 can curve over the distal tip of the tubular body 2001, 2001’ in some embodiments. In some embodiments, the stiffness of the wire 2015 can hold the wire in place over the lip of the distal tip. In some embodiments, the wire 2015 can be affixed to the interior of the tubular body using, for example, welding, soldering, embedding, or adhering. The wire 2015 can be affixed to a distal surface of the distal tip in some embodiments. The wire 2015 can be affixed to an exterior of the tubular body 2001, 2001’ in some embodiments.
  • Figs. 20A and 20B illustrate cross-sectional views of the tubular body 2001, 2001’ with protrusions 2020 in the stowed and unstowed positions, respectively, in accordance with various embodiments described herein.
  • the tissue visualization and/or ablation device can be advanced through the interior of the tubular body 2001, 2001’. As the tissue visualization and/or ablation device advances, it begins to push against the sloped edge of the protrusion 2020. The force applied to the protrusion 2020 by the tissue visualization and/or ablation device causes the first section 2002, 2002’ and the second section 2003, 2003’ to move apart.
  • the shape of the protrusion 2020 can be selected to cause a gentle flex motion in the first section 2002, 2002’ or the second section 2003, 2003’ rather than a sharp or immediate flex motion.
  • One or more protrusions can have a concave shape so as to partially extend around the cylindrical shape of the tubular body (e.g., stylet) inserted into the working channel. Note that embodiments employing a stylet can use a stylet that is shaped to minimize or eliminate displacement of protrusions during removal.
  • the protrusions can be rigid or inflatable.
  • the inflatable member 2030 can include a membrane containing a chemical that undergoes a reaction to produce gas when activated.
  • the expanding gas can expand the membrane of the inflatable member 2030.
  • gas or liquid can be provided by a tube connected to the inflatable member 2030 from the proximal end of the tubular body 2001, 2001’.
  • the first section 2002’ and the second section 2003’ have sufficient stiffness/elasticity that they return to their original location (i.e., unflexed) after deflation of the inflatable member 2030.
  • Fig. 23 illustrates a cross-sectional view of the tubular body 2001, 2001’ with a thinned portion 2040 in accordance with various embodiments described herein.
  • the thinned portion 2040 provides a focus point for bending to occur thus providing predictable bending motion when the first portion 2002, 2002’ or the second portion 2003, 2003’ are flexed by the actuating mechanism.
  • the thinned portion 2040 can be substituted by other hinge mechanisms whereby the first section 2002, 2002’ and the second section 2003, 2003’ pivot about the hinge mechanism when flexed by the actuating mechanism.
  • the point of the hinged mechanism or thinned portion 2040 may be narrow to improve the capability of the sections to flex.
  • Fig. 24 illustrates a cross-sectional view of the tubular body 2001, 2001’ composed of two materials with dissimilar stiffness in accordance with various embodiments described herein.
  • the tubular body 2001, 2001’ can include a first material 2051 having a first stiffness value and a second material 2052 having a second stiffness value.
  • the second stiffness value is greater than the first stiffness value.
  • the first material 2051 and the second material 2052 can be cold-welded or co-extruded in some embodiments.
  • the first section 2002, 2002’ and/or the second section 2003, 2003’ can preferentially flex outward due to the differential stiffness across the wall of the tubular body 2001, 2001’.
  • Previous embodiments described herein focused mainly on use of an inside approach to place the instruments (e.g., epiduroscope or tubular body) proximate to the tissue to be treated.
  • systems and methods as described herein can also be deployed using an outside approach to the tissue.
  • the outside approach represents a more direct approach to the tissue to be removed such as ligamentum flavum, superior articular process, osteophytes, and bony tissue of the intervertebral foramen whereby the tissue can be ablated or removed from a posterior position rather than from inside the patient.
  • the outside approach may be contrasted to the inside approach as described previously wherein the epiduroscope is inserted into the epidural space anterior to the tissue to be ablated.
  • a shield can be deployed in some embodiments to protect the spinal canal from exposure to energetic ablation processes, and mechanical tools designed to remove or to reduce the volume of, for example, ligamentum flavum, vertebral discs superior articular process, foraminal tissue overgrowth that are compressing the spinal column such as the spinal canal and the nerves.
  • Figs. 25A-32B illustrate a procedure for deploying a shield, ablating or removing tissue using an external approach, and removing the shield.
  • the shield can be deployed as well to protect the spinal canal when an internal approach is used and no matter the tissue composition to be ablated (e.g., ligamentum flavum, vertebral disc, or other tissue).
  • Figs. 25A and 25B illustrate two views of a portion of a spine affected by spinal stenosis.
  • the ligamentum flavum is enlarged and compresses the spinal column from a posterior position.
  • Other structures that can cause stenosis include bony and tissue growth of the superior articular process and the intervertebral foramen.
  • Figs. 26A and 26B illustrate two views of placement for a catheter 2602 that includes the shield and placement of the external scope or tool 2604 for ablation or removal of tissue using an outside approach.
  • the epiduroscopes 1700, 1800, 1900, 1950 and tubular bodies 2001, 2001’, or other endoscopes (that could include posterior, anterior, or lateral approaches) described previously herein are suitable for use with this procedure.
  • the external scope 2604 can provide both visualization of tissues and ablation (e.g., laser ablation) in a single instrument as described previously.
  • the tool 2604 can be a hollow cannula for insertion of a tissue removal tool and when needed, followed by insertion of a scope in the cannula to confirm removal of tissue and assess for bleeding and/or the need for more tissue removal.
  • the catheter 2602 can include a tube or tubular body having an outer diameter of less than 3 mm.
  • the catheter 2602 can have a circular or oval cross-section. An oval shape can have a diameter up to 5 mm wide and may be more shaped more advantageously geometrically for some situations.
  • the catheter 2602 can be introduced into the epidural space through the stenotic segment. Once the catheter 2602 has been placed, a shield 2610 can be deployed from inside the catheter 2602.
  • the shield 2610 can include a folded or coiled element that is retained within the catheter 2602 during catheter insertion. Then, an outer sheath of the catheter 2602 can be withdrawn and the shield 2610 can spread.
  • the shield 2610 spreads like a ribbon (eccentric or concentric).
  • the shield 2602 can include nitinol.
  • the shield may be composed of membrane between two nitinol tines that gets deployed as the catheter is withdrawn as described below with respect to Figs. 35A-35B.
  • the shield 2610 can be made at least partially of a material resistant to mechanical energy, optical energy or heating. In this context, resistance indicates that the material does not allow optical energy to pass through and effectively dissipates light and heat energy.
  • the shield 2610 can be color coded and/or can be made of a radiopaque material.
  • the external cannula or scope 2604 can have an outer diameter of less than 5 mm, or alternatively, less than 10 mm in some embodiments.
  • the outer diameter can be in a range from 3 mm to 10 mm in various embodiments.
  • the external cannula or scope 2604 may have an ovoid shape.
  • the distal tip of the external cannula scope 2604 can include a slit or other structure that allows for dilation of the space at the tip of the external cannula or scope 2604 to increase the working field or field of view during or after placement of the external cannula or scope 2604.
  • the external cannula or scope 2604 may be rigid.
  • the external scope 2604 can include visualization channels, light emitting elements, and tissue removal devices (such as optical fibers) or other channels passing therethrough.
  • the visualization channel can include a CMOS camera that has a cross-sectional area of less than 2 mm in some embodiments.
  • the external cannula or scope 2604 can ablate tissue using light from the optical fiber or can include other tissue removal devices such as mechanical hydrodissection, ultrasonic, coblation, and quantum molecular resonance (QMR) devices (e.g., the QMR probe from Parimed GmbH, Stansstad, Switzerland).
  • the external cannula or scope 2604 can include one or more ports for irrigation and/or suction.
  • the visualization channel and the tissue removal device can be recessed with respect to the tip of the external scope. Because the tip can be hinged and expanded/dilated in some embodiments, the use of a recess creates an even larger field of view than if the imaging device or tissue removal device (such as an optical fiber) is even with the end of the tip.
  • an imaging device e.g., camera
  • the optical fiber can be located 2 cm away from the tissue at placement.
  • Figs. 27A and 27B illustrate views of the resulting configuration after withdrawal of the catheter 2602 to allow the shield 2610 to expand.
  • the shield 2610 protects the spinal canal and nerves from the energy of ablation and also provides radiological guidance.
  • the shield 2610 in its unfolded state, can include a circular or rectangular element.
  • a diameter of the shield 2610 can be in a range from 1.5 cm to 5 cm.
  • a width of the shield 2610 may be in a range from 2 mm to 10 mm.
  • a length of the shield 2610 may be in a range from 2 cm to 10 cm.
  • a thickness of the shield 2610 may be in a range from 0.1 mm to 1.5 mm.
  • Figs. 28 A and 28B illustrate views of the process of laser ablation using light from an optical fiber in the external scope 2604.
  • the optical fiber can include a carbon-dioxide (CO2) laser fiber with an outside diameter of 1.02 or 1.2 mm.
  • the tip of the optical fiber can be formed of a metallic material in some embodiments to protect the optical fiber and improve efficiency.
  • a relatively inert gas e.g., helium or nitrogen
  • CO2 can be used although laser output energy will be diminished.
  • the CO2 laser can be operated in super pulse mode to reduce charring and maximize ablation of the tissue.
  • a port or channel on the external scope can be used for suction to remove smoke and minute debris and/or irrigation to remove charring.
  • the irrigation may be intermittent in some embodiments.
  • the optical fiber can output 15 W of power at the tip in some embodiments.
  • one gram of ligamentum flavum can be reduced to half a gram after 2 minutes of ablation.
  • the amount of ligamentum flavum to be removed for relief of spinal stenosis varies between 1 gram and 4 grams per level (i.e., per vertebra).
  • one gram of vertebral disc can be reduced to half a gram after 1.5 minutes of ablation, and the amount of disc tissue that must be removed to relieve stenosis can be as low as one gram in some embodiments.
  • Figs. 29A and 29B illustrate views of the spine at the end of the ablation process.
  • the removed portion 2620 surround by a lightly dashed line indicates the extent of the bulging ligamentum flavum that has now been removed.
  • Figs. 30A and 30B illustrate views of the spine after the catheter 2602 has been advanced back over the shield 2604.
  • the construction of the shield 2610 is configured to promote folding or collapsing of the shield 2610 upon application of pressure from the advancing outer sheath of the catheter 2602.
  • the shield 2610 can include ribbing or other structural elements that cause the shield 2610 to fan out when the catheter is retracted and fold up when the catheter is advanced.
  • Figs. 31 A and 3 IB illustrate views of the final anatomical configuration wherein stenosis caused by a bulging ligamentum flavum has been alleviated.
  • a scope may be inserted into the cannula for bleeding check, and to confirm adequacy of decompression and need for more passes where the tissue removal device is re-inserted one or more additional times into different regions or along different axes.
  • Procoagulant medication may be injected if needed at this stage.
  • the catheter 2602 can be extended or relocated to a different position rather than removed.
  • the catheter and shield can be repositioned behind the ligamentum flavum on the same side or the opposite lateral side to facilitate removal of the ligamentum flavum on that side.
  • the catheter 2602 can be advanced or retracted vertically (i.e., along the spinal canal) to facilitate removal of ligamentum flavum or other tissue at a different vertebra.
  • the catheter 2602 can be advanced into the posterior epidural space over the ligamentum flavum or the anterior epidural space over the herniated disc.
  • the shield 2610 can be deployed by retracting the outer sheath of the catheter 2602.
  • the external scope 2604 can be inserted using an interior approach and ablation can commence. After ablation has occurred, the shield 2610 can be stowed and the catheter 2602 and external scope 2604 withdrawn.
  • tissue removal device When using alternative ablation methods to laser ablation in the tissue removal device such as ultrasonic, hydrodissection, coblation or QMR, it may be desirable to provide continuous saline irrigation through the external scope 2604 rather than intermittent irrigation. In such cases, the tissue removal device can be mobile to directly contact the tissue.
  • more than one catheter and shield may be deployed to protect larger areas.
  • measurements are obtained from a radiographic image of a spine to aid in a determination of the size of shield 2610 that is desirable to deploy.
  • the distance along the ligamentum flavum to the right of the spinal canal is about 15 mm.
  • two shields of the same or dissimilar sizes could be deployed side-by-side or one-in-front-of- the-other.
  • the distance along the ligamentum flavum to the left of the spinal canal could be protected by two shields measuring 8 mm and 5 mm.
  • the halfdistance along the vertebral disc anterior to the spinal canal measures about 9 mm in this patient.
  • a single 18 mm shield could be deployed or, alternatively, two 9 mm shields could be deployed in various embodiments.
  • Figs. 33A and 33B illustrate the external cannula or scope 2604 before and after dilation of the distal tip, respectively, to increase the field of view in accordance with various embodiments described herein.
  • the external scope 2604 can include multiple elements included within by the tubular body 3302.
  • the tubular body 3302 has one or more hinges 3304.
  • a visualization channel 3311 lies within the tubular body 3302 through which imaging devices and/or illumination devices 3313 can be deployed.
  • elements within the visualization channel 3311 can be advanced or retracted with respect to the distal end 3301 of the tubular body.
  • the imaging device 3313 can be positioned several centimeters away from the distal end 3301 within the tubular body 3302.
  • the imaging device 3313 can be positioned proximal to the hinge 3304 in some embodiments.
  • a fluid channel 3307 can be included in the tubular body 3302.
  • the fluid channel 3307 can be used to flow liquid (e.g., saline) to the distal end 3301 of the external scope 2604 in some embodiments.
  • the fluid channel 3307 can be used to suction fluids or gases (e.g., smoke) away from the distal end 3301 and through the fluid channel 3307.
  • the external cannula or scope 2604 can include a working channel 3305 through which tools or devices to cut or ablate tissue may pass.
  • a tissue removal device 3310 may pass through the working channel 3305.
  • the tissue removal device 3310 can extend from the working channel 3305 or be contained entirely within the working channel 3305 in different embodiments.
  • the tissue removal device 3310 can be extended or retracted relative to the working channel 3305 in some embodiments.
  • the tissue removal device 3310 can include devices that apply energy to the tissue to bum, cut, singe, or ablate the tissue.
  • the tissue removal device 3310 can utilize laser light, heat, electricity, ultrasound, coblation, QMR, or other techniques to affect the tissue.
  • the tissue removal device 3310 may be substantially in the form of an optical fiber as described above. In such an embodiment, it may be desirable to position the distal end of the tissue removal device 3310 at a recessed location with respect to the distal end 3301 of the tubular body. In other embodiments wherein the tissue removal device 3310 operates by directly contacting tissue, the tissue removal device 3310 can extend beyond the distal end 3301 of the tubular body 3302.
  • the distal end 3301 of the tubular body 3402 may be dilated upon deployment in some embodiments. Expansion of the diameter of the distal end 3301 may be accomplished as described above with respect to Figs. 19A-24 in some embodiments. In some cases, only one hinge 3304 is deployed.
  • the setback may enable improved focusing for the tissue removal device 3310 in the form of a laser because the focal point can be located, e.g., several centimeters away from the end of the tissue removal device 3310.
  • Figs. 34A-34C depict deployment of the shield 2610 from the catheter 2602 according to some embodiments.
  • the catheter 2602 has been advanced to the proper position for deployment of the shield 2610 within the epidural space of the patient.
  • the shield 2610 is still folded within the catheter 2602 at this stage.
  • the catheter 2602 is retracted to begin to expose the shield 2610.
  • the exposed portion of the shield 2610 may retain its folded character or may begin to unfold.
  • the narrowing portion 2611 of the shield 2610 extends out from the catheter 2602, the shield 2610 begins to expand and unfold.
  • the final, unfolded shield 2610 is depicted in Fig. 34C.
  • the catheter 2602 can be advanced over the shield 2610. As the catheter 2602 advances, the catheter engages with the narrowing portion 2611 to urge the shield 2610 back into a folded position.
  • the shield 2610 can be formed at least in part of nitinol.
  • the shield 2610 includes more than one component such as a polymer membrane with a second component embedded therein.
  • the shield 2610 can include a polymer membrane at the narrowing portion 2611 and forming a full or partial frame around a target region 2612.
  • the target region 2612 can include nitinol that is untreated or treated with an agent that increases resistance to the energy of ablation, e.g., laser energy.
  • Figs. 35A and 35B illustrate a shield 2610 having a membrane 2613 attached to tines 2612.
  • the tines 2612 may be formed of nitinol or a shape memory metal, for example.
  • the tines 2612 may be pre-stressed such that they curve outward or desire to bend outward or curl.
  • the shield 2610 is stowed inside the catheter 2602.
  • the catheter 2602 is retracted and the shield 2610 extends from the end of the catheter 2602.
  • the tines 2612 bend outward to unfold the membrane 2613.
  • the membrane 2613 thus extends beyond the diameter of the catheter 2602 to create a larger protective area to protect the spinal canal/nerves/dura mater from exposure to the energy of ablation during a procedure.
  • Figs. 36-39A and 41 illustrate transverse views of steps of a procedure for spinal decompression using a contralateral approach to insert a surgical tool to remove the stenosis.
  • Conventional methods have been developed for minimally invasive lumbar decompression (MILD).
  • MILD minimally invasive lumbar decompression
  • these conventional procedures have several drawbacks.
  • conventional methods typically use an ipsilateral (same side) approach from inferior segment for inserting the instruments.
  • the stenosis is often more pronounced laterally in the lateral recess because of hypertrophy of the superior articular process and foraminal narrowing because of bony overgrowth and this approach from the inferior segment means that it is difficult to enter the area of the lateral recess and the foramen.
  • Fig. 4 illustrates a portion of a spine having a stenosis caused by bulging ligamentum flavum.
  • the stenotic vertebral level is first identified using conventional imaging techniques.
  • the laminae above and below the stenosis are identified using the x-ray images or magnetic resonance imaging (MRI).
  • MRI magnetic resonance imaging
  • Fig. 36 illustrates placement of a wire or sheath that operates as a protective membrane 3610 between the thecal sac 3622 and the ligamentum flavum 3627 and as a radiological marker.
  • the placement of the wire or sheath 3610 is preferred and can demarcate the safety zone.
  • the safety zone is the space within which surgical tools can operate to decompress the stenosis without damaging nerve tissue in the thecal sac.
  • a needle is inserted into the epidural space at a less stenotic or non-stenotic level. In exemplary embodiments, the level where the needle is inserted is below the stenosis or sacrum. A wire is placed and the needle is removed.
  • the membrane can be placed at the midline and serve as a guideline for decompression of both lateral sides with a single membrane placement or can be placed only on one lateral side at a time during decompression of that side.
  • the membrane can serve a protective function by protecting the dura mater and nerves from heat, vibrational energy, and mechanical energy.
  • the wire, sheath, or shield can be substantially similar to or can include the shield 2610 or membrane 2613 described above with respect to Figs. 34A-35B. In some embodiments the wire or sheath may not be inserted and procedure done based upon the location of the ventral interlaminar line
  • the angle is based on initial magnetic resonance imaging (MRI) and does not exceed 45 degrees.
  • MRI magnetic resonance imaging
  • VILL ventral interlaminar line
  • a surgical instrument placed behind (i.e., generally posterior to) the VILL is in a safe area and can access the ligament and the bone.
  • the insertion point of the decompression tool is identified between the laminae on the CLO view and behind the VILL, usually several centimeters from the midline and at the same vertebral level as the stenosis.
  • the contralateral location of the insertion point can depend upon patient size.
  • the contralateral oblique axis of the tool can be determined from a 3D imaging procedure, preferably the magnetic resonance imaging (MRI) and/or fluoroscopy of the treatment level and ranging along an axis extending from 20 degrees to 45 degrees oblique from the anteroposterior view while the tool is observed at a CLO axis of 35 to 45 degrees to ascertain the location of the distal tool tip in relation with the ventral interlaminar line.
  • a sharp introducer tool 3630 can be advanced from the contralateral side up to a location 3605 at the middle of the spine, i.e., the spinolaminar junction. In one embodiment, the tool is then advanced to the location 3604 of maximal insertion for stenosis decompression.
  • the introducer tool 3630 includes a small drill, ultrasonic bone shaver, or other decompression tool to remove hard tissue such as bone if the introducer tool cannot otherwise advance beyond the location 3605 at the spinolaminar junction.
  • the introducer tool 3630 is attached to a powered drill and advanced into the spinolaminar junction with rotational motion .
  • the stylet is removed and then tool is advanced into the stenotic area maximally the distance to be advanced is based upon anatomy and target and may be advanced into the dorsal lateral recess and up to the intervertebral foramen (IVF).
  • Decompression using the decompression tool 3640 can be performed using fluoroscopic visualization (e.g., CLO view or other angle view) or using direct visualization with an imaging device optically coupled to a sensor at the distal end of the decompression tool 2640 or introducer tool 3630.
  • the direct visualization can be intermittent (i.e., alternation between visualization steps and decompression steps) or continuous (i.e., visualization can be performed during decompression).
  • the decompression tool 3640 or introducer tool 3630 includes a small camera or other imaging device at the distal end to enable direct visualization as described in conjunction with other embodiments herein.
  • the decompression tool 3640 can utilize one or more techniques to ablate, debulk, or remove tissue.
  • the decompression tool 3640 can include mechanical withdrawal of tissue in stages or continuously using a withdrawal mechanism such as an Archimedes screw.
  • the decompression tool 3640 can include an ultrasonic decompressor or aspirator.
  • the ultrasonic aspirator uses ultrasonic frequency vibration to dissect/remove tissue that can then be emulsified under irrigation. Aspiration then removes the emulsified tissue.
  • the decompression tool 3640 can include a laser ablation device or a quantum molecular resonance based removal device, by coblation (RF) energy or other methods described herein.
  • RF coblation
  • Fig. 39A illustrates further insertion of the decompression tool and additional removal of ligamentum flavum all the way to the superior articular process and dorsal lateral recess at location 3604.
  • the tool may also be advanced into the foramen to accomplish a foraminotomy.
  • additional tissue removal can be done in another plane.
  • the introducer tool can be directed cephalad or caudad at the spinolaminar junction (location 3604), and the decompression tool can be advanced as described above in a new plane that is cephalad or caudad, respectively, with respect to the initial removal.
  • the spinolaminar junction may function as a fulcrum to mobilize the decompression tool in the craniocaudal plane.
  • parts of the edges of the laminae may also be thus removed effectively accomplishing a functional laminectomy. Additional discussion of tissue removal in multiple planes appears below in relation to Fig. 51.
  • Preferred embodiments utilize a tissue cutting device inserted into the cannula that receives tissue upon insertion of the cannula with fluoroscopic guidance. The cannula will generally be inserted one or more times in sequence to capture and remove portions of tissue during the process.
  • Figs. 50-52 illustrate insertion of the a tube and different angles and/or positions. The method uses a tissue cutting device configured to maximize the amount of tissue being removed with each insertion and cutting step.
  • a 7 mm or smaller, or 10 mm or smaller diameter cannula 3650 such as a rigid cylindrical cannula 5-8 inches long made from steel or other biocompatible material, that is inserted with a stylet that can be driven along the contralateral oblique axis from twenty to forty five degrees and visualized with a contralateral oblique view of 35-45 degrees approximately parallel to the fluoroscopic beam that is transmitted from an x-ray source 3674 to a detector 3660 along beam axis 3675.
  • the cannula moves up to, or across the spinolaminar junction.
  • the cannula is preferably a partially radiolucent material.
  • the angle of the cannula longitudinal axis 3677 relative to the fluoroscopic beam axis 3675 is less than 15 degrees, or alternatively, less than 25 degrees and preferably less than 15 degrees for the majority of patients.
  • the cannula 3650 can be held with simple handle that does not obscure the field of view, or can be held with an armature 3678 so that the user’s hand is not within the fluoroscopic image.
  • the armature 3678 can also having a rotating component that drives rotation of the cannula by a bevel gear that attaches to a pinion so that the distal edge cuts tissue during insertion.
  • a motor 3676 in the armature base 3670 can drive rotation of the cannula, or a handle 3654 attached to the cannula can include a motor 3658 to drive cannula rotation.
  • the motors can be actuated in a separate controller or by a manual control element 3656 in the handle.
  • the base 3670 can also be attached to a c arm 3672 or can comprise a table with a mechanical arm that controls alignment of the x-ray source and the detector axis relative to the cannula orientation.
  • the mechanical arm can stabilize the angle of the cannula relative to the AP view and also stabilizes the cannula.
  • the inner tube 3650 as described hereinafter extends through the outer tube or cannula 3650 during the tissue removal process.
  • a computer 5100 having one or more processors and a graphics processing unit can control operations of the imaging device and the robotic motorized components of the system.
  • the computer can also process image data that is generated by the imaging device(s) and can store and process images stored in memory 5104 including reference images such as 3D images obtained by MRI and/or CT imaging systems of the spinal region as described herein.
  • the images can be displayed on display 5102 for use by the surgeon to precisely insert the tool and cannula into the surgical site along the CLO axis and orient the imaging device for viewing at different angles as described herein.
  • a tubular body comprises at least two components in which a first component or portion of the tubular body has about 25%-50% of the circumference open on one side that receives a second tubular component or portion with a moveable sharp edged metal sheet extending up to 5-10 mm from the tip.
  • the second tubular portion matches the size of the opening in the first component wherein the second tubular component slides longitudinally from the open position to a closed position along a track or rail 3978 on the first component to occlude the distal lumen of the tubular body.
  • a radiopaque sheet or barrier can be inserted into the dorsal epidural space from below the stenotic level as described herein to delineate the boundary of the dorsal epidural space.
  • the metal sheet is released or pushed to cause it to move across the lumen at least partially as shown in Fig. 39G2 and then fully to occlude the lumen as shown in Fig. 39G3.
  • the inner wall is then detached from the outer wall at the handle by twisting motion and the entire inner tubular body with the metal sheet occluding the entrained tissue is withdrawn and the entrained tissue removed.
  • Ventral interlaminar line and degree of hypertrophy is used as a guide to determine appropriate depth and angulation.
  • the stylet is removed and the cannula advanced into the stenotic segment under fluoroscopic control using ventral interlaminar line and staying outside the epidural space.
  • an inner cannula with a sharp blade or wire 3691 dividing the lumen and having an internal roughened surface 3698 is advanced through the outer cannula 3690.
  • the inner cannula is rotated 3695 at the tip cutting the tissue outside the cannula from tissue 3694 inside the cannula.
  • the inner cannula is then removed from the body and retained tissue 3694 is pulled out of the lumen.
  • the outer cannula is then moved back up to close to the spinolaminar junction and reinserted, where the number of passes and cephalocaudal angle is determined by the patient’s anatomy. After a plurality of passes, preferably at least three, enough tissue is removed. An endoscope may then be passed into the cannula to assess decompression as well as look for bleeding. The procedure is then repeated on the other side.
  • an inner cannula with a removable spiral 3904 comprising a metal tube 3905 is advanced through the outer cannula 3902.
  • the inner tube 3905 can be rotated 3909 with or within the outer cannula 3902 to engage tissue 3908 within the tube 3905 as seen in Fig. 39E2.
  • the distal edge 3908 of the spiral cuts tissue as it rotates into the tissue.
  • the inner tube is withdrawn 3912 with the tissue 3910 within the spiral segment that has been detached from tissue remaining distal to the spiral cutting edge 3908.
  • the outer cannula can have a stop element at 3911 to prevent distal movement outside the outer cannula of the spiral segment.
  • the proximal handle 3914 of the outer cannula can also stop the movement of the inner cannula to prevent the exit of the spiral edge from the outer cannula at the distal end.
  • the outer cannula has markings 3915 visible to the user to ascertain the depth of the distal end and a hard stop barrier preventing any further advancement of the inner cannula beyond the stop as described above.
  • the outer cannula also has grooves optionally allowing it to be power driven in a rotational motion by a powered arm allowing the operator to keep their hand out of the fluoroscope beam.
  • the stylet is removed at or about the spinolaminar junction and the outer cannula with metal spiral inserted and advanced into the stenotic area to a predetermined depth usually less than 3 or 4 cm approximately parallel to the fluoroscope beam but final angle and depth of insertion is based upon the patient anatomy.
  • Ventral interlaminar line and degree of hypertrophy is used as a guide to determine appropriate depth and angulation.
  • the insert is such that the tissue is caught between the spiral folds and extracted upon removing the inner cannula.
  • the inner insert is withdrawn and entrapped tissue is removed.
  • outer cylindrical cannula is then withdrawn and the spiral insert replaced and readvanced in a different craniocaudal orientation to address the remaining tissue residing in the stenotic region on a first side of the spinal column and the process repeated as necessary. The procedure is then repeated on the other side of the spinal column.
  • FIGs, 39F1-39F4 A similar procedure is shown in Figs, 39F1-39F4 in which the outer cannula 3920 has a distal protrusion 3922 that serves to deflect a distal end 3928 of inner tube that is sufficiently flexible to bend upon contact with the proximal side or protrusion 3922 at 3926.
  • the distal side 3924 of the protrusion allows the tissue entering the tube to be cut.
  • the edge 3928 of the flexible portion of the inner tube 3942 cuts the tissue 3950 as it moves across the lumen aperture.
  • the cut tissue 3952 within the tube can be removed with the inner tube being withdrawn 3960.
  • the opposite side of the inner tube can have a ledge 3944 that retains the distal edge 3928 during removal.
  • Figs 39H1 and 39H2 illustrate methods 4100 for x-ray visualization in which an x-ray source 4104 emits a beam 4106 that is detected with detector 4102 to image along a first imaging axis such as substantially along, or parallel to, the insertion axis of a tool 4108 to as described herein.
  • the beam can extend along a second imaging axis 4122 such as the AP view 4120 of the spinal region.
  • the different imaging views can be registered to a 3D image obtained by x-ray computed tomography, for example, and thereby enable viewing of the position of the tool during insertion relative to the target tissue and avoid contacting the spinal canal and potentially damaged the nerves within the thecal sac.
  • Figs. 39H3-39H10 in which the procedure first involves the insertion of an outer cannula 4140 that is advanced to the spinolaminar junction and stylet 4158 is then removed.
  • the outer cannula shaft 4151 has sharp distal edges or teeth 4148 allowing the distal end 4150 to be advanced directly into the stenotic area to be removed up to 4 cm beyond the spinolaminar junction.
  • the cannula can have a cap 4146 with patterned handle 4144 to enable manual rotation.
  • the distal end 4150 can penetrate the tissue and shave small portions of bone that may impede the forward movement along the planned pathway.
  • the cannula shaft 4151 is inserted through aperture 4165 in the arm 4163 and is engaged with anchoring collar 4164.
  • an advancing nut 4154 (Fig. 39H7) is secured to the cap 4153 of the cannula.
  • the advancing nut has internal thread that engages the outer thread 4157 of the tissue removal tool.
  • the tissue removal tool 4155 is then advanced into the cannula and stops at 4 cm or less proximal to the tip of the outer cannula.
  • the distal 4 cm of the tissue removal tool is composed of a thin cylindrical attachment that ends with a circular blade or spiral 4156 and has a cavity to capture tissue within the cannula that is proximal to the blade.
  • the tissue removal tool is then advanced into the stenotic tissue.
  • the pitch of the internal thread on the advancing nut matches the pitch on threading 4157 on the circular blade.
  • the circular blade is advanced to the tip of the cannula without dislodging the tissue inside the cannula.
  • the entire tissue removal tool and the advancing nut are removed together and the entrained tissue in the cannula is removed.
  • the cannula is moved back to the spinolaminar junction and the procedure repeated if needed at different craniocaudad angles until enough tissue can be removed in further removal steps.
  • An exploded view of the tool delivery assembly is shown in Fig, 39H7 with an enlarged view of the handle 4162 and arm 4163 connecting the handle and rotating drive to the extractor opening 4165 that receives the extractor 4151.
  • the gear element 4147 on the extractor cap 4153 engages the gear element 4167 on coupler 4166 that is driven by the rotation of drive shaft 4160 that is actuating by manual operation of a switch 4178 on the handle 4162 operating an internal motor 4167 or optionally with an external drill coupled to the cannula.
  • a user inserts the extractor into the cannula after formation of an access channel with the stylet, and with the advancing nut 4154 in place, the user can advance the extractor as shown in Fig. 39H10 into the tissue to be removed with controlled rotation of the screw or circular blade 4156.
  • the cam 4166 driven by the shaft 4160 that is rotated by the motor 4167 with s similar linkage or a belt drive.
  • the teeth 4167 on the gear 4166 seen in Fig. 39H5 engage the teeth 4147 on the gear element on the cap 4153 on the cannula.
  • Fig 39H11 shows a system of injecting local anesthetic and other medications through the stylet and through the cannula.
  • Fig 39H11 shows a stylet with an internal hole that terminates at one of the beveled edges. The internal hole ends with a female connection for an extension piece. Normally the hole is occluded by an obturator that is screwed on to the cap of the stylet. When needed the obturator may be removed and the female connection connected with an extension piece to allow injection of local anesthetic at the tip of the stylet.
  • Fig 39H11 shows a system of injecting local anesthetic through the cannula 5006.
  • Figs. 39H12a and 39H12b illustrate a process sequence 4600 for using a reference or prescan image of the spinal region of the patient to be treated in which a magnetic resonance image (MRI) or a computed tomography (CT) image 4602 of the spinal region that provides three dimensional image data in which selected planes can be used to select a path 4604 for insertion of a cannula and surgical tools into the spinal region to remove spinal stenosis tissue without damaging the thecal sac.
  • the images are stored in a memory 5104 and can selectively accessed and viewed.
  • a processor 5100 is programmed to compare the selected insertion path to x-ray or other images obtained during the procedure to assist the surgeon in accurately positioning the cannula for removal of the target segments of the tissue to be removed.
  • Devices and methods used for positioning of other instruments relative to skeletal features are described in US Patent Nos. 7831096, 10105145, 11633233, 11779396 and published applications WO2017/158592, US Application 2022/0133412, the entire contents of these patents and application being incorporated herein by reference.
  • a plurality of images 4606 are acquired, preferably using fluoroscopy as different angles relative to the CLO insertion axis for the cannula.
  • These images are registered or compared 4608 to the planned insertion axis to insure accurate positioning of the tool relative to the target tissue.
  • the processor is configured to indicate the planned path on a display 5102 along with the acquired images so that the surgeon can view the position of the cannula relative to the planned path and adjust the orientation during advancement.
  • This imaging process can be used to precisely deliver 4610 the cannula and subsequently the extraction tool for repeated entry and removal 4616 of the tool to remove sequential portions of spinal stenosis tissue.
  • an endoscope camera can optionally be used 4612 in the cannula to verify proper positioning before insertion of the removal tool.
  • Anesthetic and/or therapeutics can optionally be injected into the tissue before removal 4614 or after portions are removed 4618 as needed.
  • the components described above for decompression can be assembled as one or more kits to be used for each procedure as described.
  • the individual components can be manufactured using traditional machining and tube forming processes.
  • Various components can also be manufactured by known metal molding techniques or combinations of these techniques for assembly of the cannula stylet, an inner tube embodiments.
  • Flexible materials can comprise metal and/or polymer materials and composites.
  • Fig. 40 illustrates placement of the shield member 3610 on the opposite lateral side and removal of ligamentum flavum by opposite contralateral insertion of the decompression tool 3640.
  • the membrane may also optionally be placed in the midline serving as a landmark for both sides to be decompressed without the need to place the membrane additional times.
  • FIG. 41 upon removal of the tool there is expansion of the now decompressed epidural column into space vacated by the ligamentum flavum after the procedure is concluded.
  • the nerves and cerebral spinal fluid (CSF) in the spinal canal can re-expand and reoccupy the newly opened area based upon how much tissue is removed by the decompression tool.
  • CSF cerebral spinal fluid
  • Fig. 43 illustrates an x-ray image in the CLO view highlighting the laminae and the ventral margin of the laminae.
  • a projection of the laminae L of each vertebra can be seen.
  • a curved line passing through the point at the ventral-most edge of each of the projected laminae in the CLO view is the ventral interlaminar line (VILL) 4050.
  • the VILL 4050 as visualized from an angle of 45 degrees or less with respect to the midline represents the safe line behind which an operator of a decompression tool can be assured that the tool will not come in contact with the thecal sac or other sensitive structures in the epidural space.
  • VILL ventral interlaminar line
  • the ligamentum flavum connects the two laminae (in this image, the lamina of the fifth lumbar vertebra and lamina of the first sacral vertebra).
  • the epidural space lies in front of the VILL 4050 connecting the ventral (i.e., anterior) margins of the laminae.
  • a normal ligamentum flavum 4010 lies almost entirely posterior to the VILL.
  • Fig. 45 illustrates an x-ray image in the CLO view showing the relationship between abnormal ligamentum flavum and the VILL 4050.
  • the ligamentum flavum 4015 connecting the fifth lumbar and first sacral vertebrae is abnormal while the ligamentum flavum 4020 connecting the fourth lumbar and fifth lumbar vertebrae is normal.
  • the ligamentum flavum 4015 protrudes into the spinal canal and encroaches on the VILL 4050.
  • Fig. 46 illustrates an x-ray image in the CLO view showing a radiopaque protective membrane inserted into the epidural space against the ventral edge of the ligamentum.
  • the membrane outlines the margin of the epidural space and/or the ventral edge of each ligamentum flavum 4015, 4020.
  • the membrane can provide a physical barrier between the ligamentum flavum and delicate tissues in the spinal canal. As such, the membrane protects the delicate structures from mechanical, electrical, or heating effects produced by the decompression process.
  • Fig. 47 illustrates an x-ray image in the CLO view at 45 degrees or less illustrating the portion of the ligamentum that can safely be debulked even in the absence of a shield.
  • Fig. 47 shows a membrane in place, not all procedures must utilize a membrane to ensure safety of delicate structures such as nerves in the spinal canal.
  • the portion 4022 of the ligamentum flavum 4015 and adjoining laminae posterior to the VILL 4050 can safely be removed in various embodiments of the present application. Because the practitioner can be assured that the delicate structures will not be found posterior to the VILL, any application of energy to remove tissue in this space does not affect the delicate tissue.
  • additional decompression may be conducted anterior to the VILL 4050 but posterior to the membrane.
  • Decompression anterior to the VILL may also be conducted in certain anatomical variants where the 3D x-ray image or MRI clearly demonstrates the presence of ligamentum anterior to the VILL especially towards the lateral recess. Nonetheless, in many cases, the effect of removing the portion 4022 of the ligamentum flavum and adjoining laminae posterior to the VILL 4050 achieves sufficient debulking to relieve the stenosis.
  • the membrane can be inserted without the need for an introducer, dilator or other spring member in some embodiments thereby simplifying the procedure.
  • Fig. 48 illustrates an x-ray image in the CLO view at 45 degrees or less illustrating the point of insertion of the introducer tool from the contralateral side.
  • Fig. 49 illustrates an x- ray image in the CLO view showing advancement of the introducer tool.
  • Fig. 50 illustrates an x-ray image in the antero-posterior projection view of the same region shown in Fig. 49.
  • the introducer tool 3630 may be used to introduce the compression tool between the laminae to allow for debulking and decompression to be conducted.
  • the introducer tool 3630 is advanced in CLO and antero-posterior (AP) projection views.
  • AP tero-posterior
  • the introducer tool 3630 Upon insertion through the skin, the introducer tool 3630 generally contacts bone at the midline point 3605. In some embodiments, slight tapping or drilling may be needed to advance the introducer between laminae and to the opposite side without breaching the VILL 4050.
  • FIG. 51 illustrates an x-ray image in the AP view showing advancement of the decompression tool in multiple superior and inferior planes.
  • the intervertabral foramen IVF and superior articulate process SAP are indicated.
  • the introducer tool 3630 is advanced from the contralateral side and contacts the midline at the spinolaminar junction (position X, 3605), where bone may be contacted. If the introducer tool 3630 contacts bone, the introducer tool 3630 can be gently tapped and advanced to position Y where the superior articulate process SAP is contacted. Decompression can be carried out between position X and position Y in multiple superior and inferior planes. In the case where the foramen is causing stenosis, the introducer tool 3630 can be advanced beyond the position y to position z, which is the foramen, under vision.
  • Fig. 52 illustrates a transverse view of advancement of the introducer tool or decompression tool from the contralateral side at an angle with respect to the midline.
  • the tool can debulk and remove ligament tissue 40 (ligamentum flavum) that is causing stenosis (compression of the nerves 43) while avoiding coming into contact with the nerves 43 or the spinal canal 41.
  • ligament tissue 40 ligament flavum
  • the angle of the tool can range from 20-45 degrees using the visualization methods as described herein.
  • the angle used in the contralateral oblique view to visualize the tool and the VILL may not exceed 45 degrees with respect to the midplane/midline of the patient; however, lesser angles may be used based upon the MRI and when a membrane is present and can be used as a guide.
  • the surgical tools for the removal of tissue as described herein can comprise a device such as that described in United States Patent Application 10/093,774, filed on March 8, 2002 and published as U.S.

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Abstract

La présente invention concerne un système chirurgical pour la décompression de la sténose rachidienne et des procédés associés. La conception du système permet le placement du dispositif par l'intermédiaire d'une approche contralatérale et l'avancée sous visualisation directe ou fluoroscopique (X-Ray), ou guidage par imagerie 3D par exemple, dans des zones de la colonne vertébrale comprenant des lombaires (bas du dos), thoracique (du milieu et haut du dos) et du col de l'utérus (col). Un corps tubulaire avec un outil de coupe est avancé pour séparer le tissu à l'intérieur du corps tubulaire pour l'élimination et la décompression vertébrale.
PCT/US2024/053685 2023-10-30 2024-10-30 Décompression vertébrale guidée par l'image avec vue oblique contralatérale Pending WO2025096629A1 (fr)

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