VISUALIZATION SYSTEMS, INSTRUMENTS AND METHODS OF USING THE SAME IN SPINAL DECOMPRESSION PROCEDURES
A method for positioning a treatment instrument in a subject involves positioning a tissue protector of a visualization instrument in an epidural space of the subject. The tissue protector is viewed and positioned in the epidural space using fluoroscopy. A treatment instrument between a first vertebra and a second vertebra and while viewing the tissue protector positioned in the epidural space. A decompression procedure is performed using the treatment instrument.
This application is a continuation of U.S. patent application Ser. No. 13/844,324 filed on Mar. 15, 2013, which is hereby incorporated by reference in its entirety.
TECHNICAL FIELDThe present disclosure relates generally to medical systems and, more particularly, to visualization systems, spinal decompression instruments, treatment systems, and methods for treating the spine.
BACKGROUNDSpinal nerve compression can be caused by narrowing of the spinal canal associated with arthritis (e.g., osteoarthritis) of the spine, degeneration of spinal discs, and thickening of ligaments. Arthritis of the spine often leads to the formation of bone spurs which can narrow the spinal canal and press on the spinal cord. In spinal disk degeneration, inner tissue of the disk can protrude through a weakened fibrous outer covering of the disk. The bulging inner tissue can press on the spinal cord and/or spinal nerve roots. Ligaments located along the spine can thicken over time and press on the spinal cord and/or or nerve roots. Spinal nerve compression can cause lower back pain, hip pain, and leg pain and may also result in numbness, depending on the location of the compressed nerve tissue. In the lower back, spinal stenosis may lead to spinal cord compression and numbness of the legs. Unfortunately, it may be difficult to treat spinal nerve compression without injuring or traumatizing non-targeted tissue.
The same reference numerals refer to like parts or acts throughout the various views, unless otherwise specified.
The following disclosure describes various embodiments in medical systems, instruments, devices, and associated methods of use. At least some embodiments include a visualization instrument that can be viewed to assist in a spinal procedure. Visualization techniques can be used to view at least a portion of a treatment instrument (e.g., a distal tip of a tissue removal instrument) and at least a portion of the visualization instrument to perform the procedure. Certain details are set forth in the following description and in
The terms “distal” and “proximal” within this description, unless otherwise specified, reference a relative position of the portions of a system, instruments, and/or associated delivery devices with reference to an operator and/or a location in the patient. For example, in referring to visualization instruments described herein, the term “proximal” can refer to a position closer to the operator, and the term “distal” can refer to a position that is more distant from the operator.
A. OverviewAt least some visualization instruments disclosed herein can be used to identify features, such as targeted tissue and non-targeted tissue, and/or used as a point of reference to position other instruments and tools. In some embodiments, a visualization instrument can be positioned to protect the spinal cord and define a working space. A series of treatment instruments can be moved within the working space to crush, separate, cut, debulk, break, fracture, remove, or otherwise alter tissue at a treatment site. If the treatment instruments move towards the spinal cord, the visualization instrument can serve as a working barrier to inhibit or prevent injury and/or trauma to the spinal cord.
At least some embodiments are methods for treating a subject (e.g., a human subject). The methods include positioning a tissue protector of a visualization instrument in an epidural space. The tissue protector can be viewed via fluoroscopy to identify margins of the epidural space, dura, ligamentum flavum, nerve roots, and/or other tissue. The wide range of different types of fluoroscopy (e.g., anterior posterior imaging, lateral imaging, contralateral oblique imaging, etc.) can be used to view the visualization instrument, as well as treatment tools or delivery devices used to perform a procedure.
At least some embodiments are methods for performing a procedure on a subject and include positioning a distal portion of a visualization instrument in a vertebral column of the subject. Another instrument (e.g., a treatment instrument) can be positioned while viewing both the treatment instrument and a distal portion of the visualization instrument under, for example, fluoroscopy. A spinal decompression procedure can be performed using the treatment instrument. In one embodiment, the visualization instrument can be a radiopaque epidural catheter having a flexible elongated main body. In some procedures, the epidural catheter can be moved along the vertebral column through any number of vertebrae. In other embodiments, the visualization instrument is a catheter configured to be positioned within the dura sac or other suitable location. Such catheters can have a relatively low profile. An opening, if any, defined by, and laterally adjacent to, the distal portion can be smaller than a distal head or tool portion of the treatment instrument. As such, the distal head of the treatment instrument is prevented from contacting non-target tissue. In some embodiments, the visualization instrument includes an elongate radiopaque wire. The wire can extend from a distal end of the visualization instrument to a proximal end of the visualization instrument.
In some embodiments, a method for positioning an instrument in a subject comprises moving the tissue protector of the visualization instrument through a subject. The tissue protector can be moved from a delivery configuration to a deployed configuration to define a working space. A decompression procedure can be performed at the treatment site while viewing the deployed tissue protector. When using a treatment instrument at the working space, the treatment instrument and non-targeted tissue can be kept on opposite sides of the tissue protector.
In yet other embodiments, a method for performing a procedure on a subject includes positioning a tissue protector of a visualization instrument in an epidural space of a subject. A treatment instrument can be moved between a first vertebra and a second vertebra while the tissue protector remains in the epidural space and viewed via fluoroscopy. A physician can view both the treatment instrument and the tissue protector before, during, and after performing a procedure using the treatment instrument.
In some embodiments, a treatment system for treating spinal compression comprises a visualization instrument including a tissue protector configured to be positioned in an epidural space and viewed using a fluoroscopy. The treatment system can further include a treatment instrument configured to perform a decompression procedure at a treatment site while the tissue protector prevents access to the spinal cord. In some embodiments, the tissue protector can cover a posterior region of the spinal cord facing a treatment site.
B. Visualization Systems, Visualization Procedures, and Decompression ProceduresThe distal portion 163 is viewable using, for example, fluoroscope, MR imaging, CT imaging, or other suitable imaging techniques. By viewing the distal portion 163, a physician can conveniently identify the location and/or margins of the spinal cord 180 and ligamentum flavum 194. The distal portion 163 can be moved to different positions to identify targeted or non-targeted tissue, which can include, without limitation, the ligamentum flavum 194, the spinal cord 180, the ligament 198, nerves branching from the spinal cord 180, vertebrae 170, 174, and other features or anatomical structures proximate to the spine. The distal portion 163 can include a tissue protector 190 (e.g., a section of the distal portion 163) configured to inhibit, limit, or substantially prevent damage and/or injury to the spinal cord 180 and can define a working space 127 (
Referring to
If the distal portion 307 is moved in the anterior direction (indicated by arrow 310) the tissue protector 190 can physically block the distal portion 307. The distal portion 307 can also be inserted into the vertebral canal 200 without injuring or traumatizing the spinal cord 180. As a result, the instrument 299 can be safely moved throughout the working space 127. The shape and configuration of the tissue protector 190 can be selected based on the configuration of the distal portion 307. For example, the tissue protector 190 can be large enough to ensure that exposed regions, if any, of the spinal cord 180 (i.e., the regions of the spinal cord 180 accessible via the interspinous space 313) are smaller than the distal portion 307.
The treatment instrument 299 can be, without limitation, a surgical instrument (e.g., a scalpel), scraping instrument, cutting instrument, or other instrument or tool for altering tissue. U.S. Patent Application No. 61/755,392, filed on Jan. 22, 2013, discloses various types of surgical instruments that can be used in, or incorporated into, the systems and methods disclosed herein. Such instruments include, but are not limited to, debulker instruments, tissue removal instruments, cutting instruments, and debulker instruments and other systems, instruments, and devices disclosed in U.S. Application No. 61/755,329, which is incorporated by reference in its entirety.
To help position the distal portion 307, both the distal portion 307 and the tissue protector 190 can be viewed using, for example, fluoroscopy. The tissue protector 190 can serve as a reference point to help the physician identify critical areas of non-targeted tissue and/or assist in positioning of the distal portion 307. In some procedures, the tissue protector 190 can remain substantially stationary while the distal portion 307 is used to perform a procedure at the treatment site 263, although the tissue protector 190 can be repositioned any number of times during a treatment session.
After completing the procedure, the instrument 299 can be removed from the subject. The visualization instrument 110 and the cannula 120 can then be removed from the subject without injuring and/or traumatizing tissue.
Visualization instruments can be delivered using other access techniques. For example,
Referring now to
Referring again to
After implanting the device 710, the treatment system 612 can be removed from the subject. The visualization instrument 610 can be pulled proximally through the cannula 120 and removed from the subject. The visualization instrument 610 and treatment system 612 can be used to treat other locations along the spine.
Referring to
In myelography procedures, a tissue protector 1333 can moved along the epidural space adjacent to the dura. The delivery element 1302 can be moved out of the aperture 1330, which faces the dura, to puncture the dura sac. After an end 1329 is within the dura, visualization media (e.g., a non-ionic contrast media) can be delivered directly into the spinal fluid surrounding the spinal cord. The delivery element 1320 can be positioned under fluoroscopic guidance to ensure that spinal nerves are not damaged or injured. After delivering the media, the delivery element 1302 can be drawn back into the main body 1323. As such, the media can be kept outside of the epidural space and localized within the dura. Myelography can provide detailed images (i.e., myelograms) of the spinal cord, thecal sac, nerve tissue (including nerve roots), or other features of interest. Additionally, myelography procedures can provide enhanced viewing of non-targeted structures (e.g., dura), and nerve roots compared to epidurography procedures. For example, visualization media of a myelography procedure may travel (e.g., via controlled leakage) to nerve roots to visualize the nerve roots when removing bone of the neural foramen. In some embodiments, myelography visualization media can be used to verify decompression of the spinal cord because the dura can move outwardly to confirm that the pressure applied to the spinal cord is decreased or eliminated. If the dura is damaged (e.g., tears, leaks, or the like), myelography visualization media can escape out of the damaged region of the dura. A physician can view the leakage to confirm that the dura has been damaged, as well as identifying the location of the damage. The physician can then repair the dura or otherwise alter the surgical procedure. Accordingly, myelography visualization media can be used to provide useful real-time feedback. Other visualization instruments disclosed herein can have delivery elements similar to the delivery element 1302 discussed in connection with
Although many embodiments discussed herein are discussed in the context of fluoroscopy, other visualization techniques can be used to view treatment instruments and/or visualization instruments to identify targeted features, treatment sites, and/or non-targeted features. Treatment instruments and/or visualization instruments can be viewed when altering tissue and/or delivering a spinal device, such as a spinal implant, a spacer device, prosthetics disk, or the like. In certain procedures, visualization instruments disclosed herein can be used to identify margins of the epidural space, dura, ligamentum flavum, and/or nerve roots relative to the lamina and interlaminar space, as well as the features of instruments.
The visualization instruments disclosed herein can be located at other locations to protect other non-target tissue. Other embodiments can include tissue protectors specifically designed to protect portions of the vertebrae, nerve roots, or other structures near the spine. Additionally, multiple visualization instruments can cooperate to simultaneously protect tissue while also serving as reference points under visualization.
CONCLUSIONThe above detailed descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. For example, features from various instruments can be combined with features and methods disclosed in U.S. Pat. No. 8,012,207; U.S. Pat. No. 8,123,807; U.S. Pat. No. 8,152,837, and U.S. application Ser. No. 12/217,662 (U.S. Publication No. 2008/0287997) which are incorporated by reference in their entireties. U.S. Provisional Application Nos. 61/639,828, 61/745,470, and 61/755,329, which are hereby incorporated by reference herein and made a part of this application. A wide range of treatment instruments can be used to address a wide range of symptoms, conditions, and/or diseases, including, without limitation, spinal nerve compression (e.g., spinal cord compression, spinal nerve root compression, or the like), spinal disk herniation, osteoporosis, stenosis, or other diseases or conditions. In one embodiment, the system 100 is used to perform a spinal cord decompression procedure, which can include removing bone from one or more vertebrae, separating the ligamentum flavum from one or more vertebrae, cutting or debulking the ligamentum flavum, and/or removing loose tissue.
Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
Claims
1.-19.
21. A treatment system for treating spinal compression of a subject, comprising:
- a delivery cannula;
- a visualization instrument including a tissue protector and an elongate body, the tissue protector is configured to be positioned in an epidural space and viewed using fluoroscopy while the elongate body extends through the delivery cannula and out of the subject; and
- a treatment instrument configured to perform a decompression procedure at a treatment site while the tissue protector prevents access to the spinal cord and the elongate body extends through the delivery cannula.
22. The treatment system of claim 21, wherein the delivery cannula has an open distal end configured to be positioned between adjacent spinous processes of adjacent vertebrae.
23. The treatment system of claim 21 wherein the tissue protector includes a plurality of deployable arms for protecting tissue while the treatment instrument is used to perform at least a portion of the decompression procedure.
24. The treatment system of claim 21 wherein the visualization instrument includes a tissue protector comprising one or more balloons, nets, and sheets.
25. The treatment system of claim 21 wherein the visualization instrument includes at least one radiopaque marker.
26. The treatment system of claim 21 wherein the treatment instrument is configured to remove bone from a vertebral column of the subject, separating a portion of a ligamentum flavum from at least one vertebra of the subject, and/or remove a portion of the ligamentum flavum from the subject.
Type: Application
Filed: May 15, 2017
Publication Date: Feb 1, 2018
Inventors: Andy W. Choi (Irvine, CA), Thomas R. Haley (Lafayette Hill, PA), Scott C. Lynch (San Clemente, CA)
Application Number: 15/594,882