JP2009532078A - Percutaneous access and visualization of the spine - Google Patents

Abstract

Devices, systems, and methods are provided for percutaneous access and visualization of the spine for the purpose of diagnosing and / or treating a target region of the spine or surrounding tissue. The present invention is a system for accessing a target site in the body, deployable from a cannula having at least one lumen, a scope deliverable through the at least one cannula lumen, and a distal portion of the cannula Including at least one strut, wherein deployment of the at least one strut creates a space in tissue adjacent to the distal portion of the cannula, the space facilitating visualization by the scope. Provide the system.

Description

  The present invention relates to percutaneous access and visualization of portions of the spine for the purpose of diagnosing and / or treating a target area or surrounding tissue of the spine.

  The spinal column is formed from a number of vertebral body parts 20 separated by an intervertebral disc 10. The intervertebral disc 10 serves primarily as a mechanical cushion between vertebrae and allows motion control (curvature, extension, lateral flexion and axial rotation) of the vertebral segments. FIG. 1A is a posterior side view of two vertebral bodies 20 separated by an intervertebral disc 10. The intervertebral disc 10 is a cushion-like pad that faces the bone surface of each vertebral body 20 to which the upper and lower endplates 12 are adjacent. From this posterior perspective, the placement of the disc 10 relative to vertebral structures such as the spinous process 60, the lower intervertebral joint 64, the upper intervertebral joint 66 and the pedicle 67 makes access to the disc 10 difficult.

  FIG. 1B is a coronal view through a healthy intervertebral disc 10 and surrounding structures. Each endplate 12 (see FIG. 1A) is made of thin cartilage that covers a thin layer of hard cortical bone that attaches to the sponge-like cancellous bone of the vertebral body 20. The intervertebral disc 10 includes a nucleus pulposus 30 (“nucleus”), a gel-like material that serves as a cushion for compressive stress. Surrounding the core 30 is a fiber ring 40 (“ring”). The annulus 40 includes multiple concentric fiber layers or sheets of collagen fibers called lamellae. The annulus 40 limits the expansion of the nucleus 30 during spinal compression and joins successive vertebrae 20 together to resist spinal twisting and assist in the absorption of compressive forces by the nucleus 30. The annulus fibrosus 40 is adjacent to the annulus fibrosus 80 spinal nerve root 82, epidural space 65, dura mater 70, puffy or spinal canal 72, and epidural venous plexus 81.

  FIG. 1C shows an example 50 of damage to the disc 10. In this view, the injury 50 is a herniated disc or an escape 52. This condition can be the result of severe or sudden trauma to the spine, or one or more disc bulges or ruptures can occur due to atraumatic lesions such as degenerative spinal disease. Denaturation or damage can reduce core moisture and lose fluidity and stickiness. The nucleus bulges outward, resulting in a decrease in the mechanical stiffness of the motion segment of the spine, which can cause instability.

  The annulus 40 is generally thinnest in the direction of the spinous process 60, so the nucleus 30 is usually hernia in that direction. Because the posterior longitudinal ligament reinforces the sagittal midline annulus behind the annulus, the damage usually proceeds posteriorly rather than straight back. The terms “rear” and “posterior” refer to the generally posterior and posterior lateral surfaces 43 of the disc that are distinguished from the anterior surface of the disc (ie, the area of approximately 41).

  As shown in FIG. 1B, the anterior surface of the annulus fibrosus 40 is painful / sensory nerve fibers 80, abdominal and / or dorsal nerve roots 82, and other delicate tissues including but not limited to spinal dura mater 70. Is distributed. As a result, posterior disc damage often affects one or more of these nerves. The resulting pressure on these nerves often results in pain, weakness and / or paralysis in the lower limb, upper limb, or cervical region. In addition, the ability of a ring once damaged is limited. Healing usually occurs in the outer layer with the development of a thin fiber membrane. However, the wheel never returns to its original strength. In many cases, the ring does not close and hernia recurrence and nuclear leakage are very likely.

  In addition to conventional rest, physical therapy, improving physical activity, and taking painkillers, an increasing number of treatments attempt to avoid surgical resection of the damaged disc by repairing the damaged disc. Many conventional treatment devices and techniques access and penetrate parts of the disc 10 under radioscopy guidance, including open surgical approaches with muscle stripping or percutaneous procedures without visualization Used for.

  One such treatment is an intervertebral disc decompression that involves decompressing and reducing pressure on the annulus and adjacent nerves by excising or shrinking at least a portion of the nucleus. Technologies and equipment have been developed to further reduce the invasiveness of this treatment. One such technique is automated percutaneous discectomy (APLD), which uses endoscopy to facilitate visualization, cuts the nuclear tissue, and vacuums the released jelly-like material. is there. However, APLD (due to the nature of the original technique) prevents the surgeon from observing the nerve root itself, so it cannot determine if the removed nucleus is the cause of the problem, and enters the spinal canal beyond the disc. It is also impossible to find and remove the substances that are present. Another technique for disc decompression is microscopic discectomy, which, as the name implies, involves the use of a microscope to enlarge the surgical field and provide adequate illumination. However, the disadvantage of this technique is that it cannot recognize adjacent lesions such as concave stenosis due to the limited field of view.

  Other therapies involve the strengthening of the disc in addition to the removal of the disc material, and the device is implanted to treat, delay or prevent disc degeneration. Strengthening includes (1) strengthening the annulus including repair of a herniated disc, supporting a damaged annulus and / or closing a torn ring, and (2) strengthening the nucleus where additional material is added to the nucleus. Point to both.

  In general, these conventional systems rely on external visualization to approach the intervertebral disc, and therefore lack the mounting of any kind of real-time visualization capability. Even when a scope is used, the ability to visualize anything other than what is directly on the course is limited, and also without depth perception to identify local lesions. A space can be created first before using the scope, but the creation of the space, if done percutaneously, must be done only with external guidance or done blindly.

  In addition to the lack of a truly effective tool for performing the procedures and techniques described above, the spinous process 60, the lower facet joint 64, the upper facet joint 66, as viewed from the posterior viewpoint of FIG. 1A. And placement relative to vertebral structures such as pedicle 67 makes access to the disc 10 more difficult. Even if the bone structure can be navigated, other anatomical structures (such as fat, connective tissue, lymphatic vessels, arteries, veins, blood and spinal nerve roots) are present along the access path and / or within the epidural space This limits the insertion, movement, and observation capabilities of any access, visualization, diagnostic, or treatment device that is inserted into the epidural space. Furthermore, even if the target space can be reached, there is still a risk of damaging the nerve root, dural sheath or other tissue structure along the way.

  In short, many of the traditional techniques for treating the spine (even those that are considered less invasive) do not provide atraumatic direct visualization. As a result, the working space for visualization is limited, there is no ability to visualize, diagnose, and treat local lesions at or near the target site, and there is a risk of damaging soft tissue.

  Accordingly, there is a need for transcutaneous methods and devices that can create a workspace in tissue atraumatically, provide direct percutaneous visualization, and allow for optimal treatment options. What is particularly needed is a minimally invasive technique and system that provides the ability to directly visualize and diagnose or repair an intravertebral or spinal target site while minimizing damage to surrounding anatomy and tissue. is there. In addition, there remains a need for methods and devices that allow physicians to effectively enter the patient's epidural space, clean areas in the space to facilitate visualization, and use the visualization capabilities to diagnose and treat spinal injury. The

SUMMARY OF THE INVENTION The present invention provides devices, systems and methods for accessing and visualizing a target site in the body. They are particularly useful for accessing and visualizing areas of the spine that are extremely limited in space, difficult to access, and at high risk of pain or injury to the patient. Such devices and systems include any spinal procedure, including but not limited to repair of herniated discs, repair of torn rings, decompression of the nucleus, implantation of an annulus or nuclear enhancement device, electrode implantation, etc. Can be used.

  One aspect of the invention provides a perspective view to the user for optimal assessment of local lesions and is adjacent to the target site to provide a working space for performing treatment or diagnostic tasks or procedures therein. And / or for creating an atraumatic space adjacent to the distal end of the scope and / or creating a path or spacing between the scope and the target site. In use, various embodiments of the devices and systems of interest employ mechanisms or components for manipulating the side, distal and / or proximal tissue of the distal end of the device or system. As used herein, tissue manipulation includes various acts on tissue including, but not limited to, moving, pushing, incising, compressing, moving and the like. These manipulations are accomplished by various means in the context of the present invention. In some embodiments, mechanical members such as frames, struts, wires, hooks, loops, etc. are used, and in others, expandable materials such as inflatable balloons and gel filled membranes are used.

  The novel functions, components and devices that enable these aspects of the invention are not necessarily, but most commonly incorporated as part of an access and delivery system or device, but the access and delivery system or device includes: Includes cannulas, trocars, catheters, guidewires, endoscopes and working tools for injecting, removing, cutting, cutting, penetrating, suturing, staples, clips, washing, inhalation, drugs, stem cells, etc. The known functions, components and devices are not limited to these, and may be included.

  Also disclosed are methods of accessing and visualizing a target site in the body, methods of manipulating tissue, and methods of using the devices and systems of the present invention.

  These and other features, objects and advantages of the present invention will become apparent to those of ordinary skill in the art upon reading the contents of the invention detailed below.

  The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not in proportion. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. To facilitate understanding, identical reference numerals are used (where useful) to indicate similar elements common to the figures.

DETAILED DESCRIPTION OF THE INVENTION The devices and instruments of the present invention are primarily intended to access and visualize target sites in the body, are very limited in space, difficult to access, It is particularly useful for accessing and visualizing areas of the spine where there is a high risk of damage. Examples of applications in which the present invention is described are spinal scenes, particularly intervertebral disc scenes. Other applications where the device of interest and its use may be employed include heart, nerve, blood vessel, intestine, genitals, where the targeted surgical site is accompanied by sensitive organs and soft tissue structures and is particularly difficult or cumbersome to access And other application scenarios.

  The target devices and equipment can be used with or as a component of other known devices and systems. For example, both are entitled “Percutaneous Endoscopic Access Tools for the Spinal Epidual Space and Related Methods of Treatment” and are incorporated herein by reference in their entirety as of the 11th patent date of March 2005. US patent application Ser. No. 078,691 and Attorney Docket No. SPVW-001 CIP filed on Feb. 23, 2006 is a disc or other tissue site in the body that may be used in whole or in part with the present invention, Or various devices for accessing, visualizing, diagnosing and / or treating target sites within them are disclosed.

  An important aspect of the present invention is a target site that provides a perspective view for optimal access to local symptoms and provides a working space for performing therapeutic or diagnostic tasks or procedures. Creation of atraumatic space adjacent to and / or adjacent to the distal end of the scope and / or the path or distance between the scope and the target site. The novel features, components and devices that enable these aspects of the invention, although not necessarily, are most commonly incorporated as part of an access and delivery system or device, but in the access and delivery system or device Known functions, configurations, including but not limited to cannulas, trocars, catheters, guidewires, endoscopes, and working tools for cutting, penetrating, suturing, stapling, clipping, injection, removal, etc. Elements and devices may also be included. Accordingly, as used herein, terms such as “access device”, “access system”, “delivery device”, etc., are generally used in the technical field of the invention as well as functions, components and devices of the invention. One or more known components or devices.

  Various exemplary embodiments of the invention will now be described. Reference to these examples is in a non-limiting sense. They are provided to illustrate aspects of the invention that are widely applicable. Various modifications of the described invention may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process action (s), or step (s) to the purpose (s), spirit, or scope of the invention. Can be made. All such modifications are within the scope of the claims made herein.

  2A-2D illustrate an embodiment of the access device 100 of the present invention. The access device 100 includes a pair of working channels 102, 104 that open at the distal end of the device 100, one of the channels, eg, the channel 102, providing direct visualization capability, scope, imaging and / or illumination. A visualization port for delivery of component 106. In an alternative embodiment, instead of a single visualization port that houses multiple components, each component may have a dedicated port that illuminates, visualizes, and analyzes the surrounding anatomical environment. While the visualization port 102 faces distally or faces forward, in another aspect (not shown), one or more side ports can be used. Tissue differentiation sensors or their functional equivalents can also be provided through the working channel. Further, the device 100 may be steerable to further increase directionality and visibility range.

  A tissue manipulation tool 114 of the present invention having a proximal shaft 112 is provided within the other working channel 104 of the device 100 and is deliverable. The tool 114 has an open frame structure 108 with struts forming a flower pedal or spoon-like shape with the concave side facing inward, ie facing the scope 106. The shape of the frame 108 (loops, curves, spirals, etc.), surface contours and overall profile minimize impact when the frame / strut contacts anatomical structures, especially nerves, muscles and spinal dura mater Selected to do. The frame / strut can be compressed into a reduced configuration (see FIG. 2C) for delivery or filling within the channel 104, and then returned to the expanded configuration as it exits the channel 104 or advances distally. (See FIG. 2D), the wireframe / strut is made of a flexible soft material such as Nitinol or a soft polymer. Further, the frame 108 can be pre-made to expand or deploy to any suitable shape. For example, in the fully deployed state, the convex side of the illustrated frame 108 extends slightly to the side of the wall of the device 100 while minimizing the obstruction of the scope view. This lateral extension provides “pushback” when in contact with the anatomy, or helps resist the inward refraction of the frame, providing maximum working space adjacent to the scope 106 To do.

  In the fully deployed state, the frame member 108 extends generally parallel to that of the outer periphery of the device body 100 and defines an arcuate range of about 270 ° or less, more typically from about 110 ° to less than about 180 °. Cross section (best shown in FIG. 2B, which provides an end view of the device). Such a frame 108 has a radial dimension (from the central axis to its outer periphery) in the range of about 4 mm to about 10 mm when expanded and may extend up to about 15 mm in a linear direction from the distal end of the access device, It can be shorter, wider, or longer depending on the application scenario considered. For moving large masses or volumes of tissue, larger arch lengths are potentially advantageous over smaller frames, but larger frames hinder visualization by the scope 106 because they may require more struts. By creating the device 114 such that the frame structure 108 can rotate or pivot within the channel 104 (as shown in FIG. 2B), the required size of the frame can be reduced and the visualization range can be increased. Additionally or alternatively, the shaft 112 and / or tool 114 may be mechanically deflectable or steerable to further facilitate visualization and space creation.

  Optionally, the webbing material 110 may extend over all or part of the open space between the struts and provide an additional surface for moving, pushing, or moving the distal tissue of the scope 106. The web material 110 is preferably transparent so as not to hinder visualization. Suitable webbing materials include, but are not limited to, polyurethane, silicone and polyester.

  Device 100 may have one or more additional working channels for delivery of any other diagnostic or therapeutic tool or drug that may be used separately or in conjunction with operational tool 114. Examples of other tools and agents that can be delivered through the device 100 include sensors, cleaning means, suction means, therapeutic delivery (eg, RF energy, removal energy, etc.), drug delivery, implant delivery, cutting means, etc. Not limited.

  FIGS. 3A and 3B illustrate another embodiment of a tissue manipulation device used with the access device 100 and the scope 106. The manipulation device includes an inflatable or expandable balloon 120 that is secured to the wire frame 118 and communicates with an inflation / expansion (gas or fluid) lumen 122. Similar to the manipulation device described with respect to FIGS. 2A-2D, the wire frame 118 is flexible and compressible and can be pre-made to profile any shape, contour and shape desired in the expanded state. Thus, depending in part on the flexibility of the balloon material, the balloon 120 generally takes the form of the wire frame 118 shown in FIG. 3B when inflated unconstrained. In the housed state shown in FIG. 3A, the balloon remains contracted until the wire frame 118 is deployed. The balloon material is preferably transparent to allow visualization past it.

  The tissue manipulation device described above provides a preformed compressible / expandable frame, but the frame need not have a preformed shape. For example, the manipulation device 136 of FIGS. 4A and 4B includes a freeform wire that can be delivered through the working channel 104. One end 134 of wire 136 is secured to a securing portion 138 of access device 100, such as within lumen 104 or on the outer surface of the device. From the fixed end 134, the wire 136 extends distally and, when undeployed, is bent at a distance 136a from the fixed site 138 so as not to extend beyond the distal end of the device 100, as shown in FIG. 4A, or It is folded. This construction provides a flat, low profile front end upon initial percutaneous insertion of the device 100. The anchoring site 138 can be anywhere along the access device 100 or lumen 104, but the closer the anchoring point is to the distal end of the device, the shorter the wire 136 can be. By minimizing the overall length of the wire 136, the risk of twisting or clogging is reduced.

  When undeployed, the remaining wire length extends proximally within channel 104 and exits the proximal end of device 100, allowing manipulation of the free end of the wire (not shown). More particularly, the free end can be manipulated to selectively advance and retract the wire 136 through the lumen 104, as shown in FIG. 4B. Upon deployment of the manipulation device, a flexible loop frame is formed as the length of the wire 136 moves forward out of the lumen 104, and its size can be easily adjusted by selecting advancement / contraction.

  In order to place the scope 106 slightly inside the “umbrella” defined by the deployed wire 136, the direction of rotation of the access device 100 can be adjusted as well. Selective manipulation of both the wire and the access device body allows the scope 106 and / or other work tool (not shown) to be advanced inward to perform the intended diagnostic or treatment task. A workspace can be created. For example, the wire 136 is gradually expanded in the distal direction to create a delivery space that allows the device 100 to enter, and the scope of further manipulation of the tissue and advancement of the device 100 and / or other instruments can be controlled by the scope 106. Evaluated by the information provided. Various operations, visual assessments and tool advancements access the intended target site, create work and visualization space around the target site, and access local lesions for specific actions, i.e. the treatment to be performed Repeated as necessary to determine the type (eg, discectomy, ring strengthening, energy application, etc.), the type of diagnosis performed, etc.

  FIGS. 5A-5C illustrate another wire type operating device 140 for use with the access device 100. The wire 140 has a pre-formed shape, but neither end is fixed or anchored. Like any wire-type manipulation device disclosed herein, a wire 140 made of a superelastic metal alloy or plastic polymer expands into its shape when deployed, as shown in FIGS. 5B and 5C. Given a pre-formed spiral or coil shape, when restrained in the port 104, it is substantially stretched as shown in FIG. 5A. The resulting coil has a winding density / spacing that is sufficiently stiff yet flexible to create atraumatically space in the tissue. The winding diameter is sufficiently large, i.e. larger than the diameter of the scope 106, usually larger than the diameter of the access device 100, to allow proper visualization or access of the region distal to its distal end 142. . The winding diameter in the expanded or deployed state may be constant or may vary along the wire. In one variation, as shown, the expanded helix has a diameter that tapers or decreases from the distal end 142 to the proximal end (not shown).

  Although the tissue manipulation devices described above are components that are relatively independent of the access devices used to deliver them, in certain variations of the present invention, the manipulation devices are structurally integrated with the access device body. The Next, an example of such an integrated device will be described.

  In the embodiments shown in FIGS. 6A / 6B and 7A / 7B, at least the distal portion of the shaft of the access device carries a radially expandable tissue manipulation member. In the undeployed state, the operating member is flush with the outer surface of the access device, as shown in FIGS. 6A and 7A. In the deployed state, as shown in FIGS. 6B and 7B, the manipulation member extends radially from the access device to move or incise 360 ° of tissue around the distal end of the access device.

  The access device 150 of FIGS. 6A and 6B provides a tissue manipulation member 156 that includes a wire or ribbon wrapped or wound around a distal portion of the shaft 152. Access device 150 may provide any number of channel lumens 160 for delivering scope 158 and any other therapeutic or diagnostic tool or agent. Ribbon 156 includes a plurality of turns or bands 154 tightly wound around shaft 152 to provide a flat finish along the outer surface of the shaft to facilitate intra-tissue delivery prior to deployment of member 156. Have. Ribbon 156 may extend (ie, wrap) any suitable distance proximally along the shaft, but typically only the very distal portion of the shaft needs to be covered. The radial expansion of the band 156 is accomplished by loosening the restraint at the proximal end of the ribbon or by applying heat if made from a temperature sensitive superelastic material. Such a band surrounds the distal portion of the shaft 152 and the extremely distal end 162 of the ribbon 156 that is substantially orthogonal (with a slight tilt if necessary) provides control over the degree of radial expansion. To maintain, it is fixed or anchored to the distal end of shaft 152.

  The access device 170 of FIGS. 7A and 7B includes a distally located tissue manipulation member that includes a plurality of axially extending bands, struts or supports 174 formed by slots 178 in the tubular material that form the manipulation member 176. 176 is provided. The strut 174 is parallel to the longitudinal axis of the access device 170. As in any intended access device, the device shaft 172 may provide any number of channel lumens 184 for delivering the scope 182 and any other therapeutic or diagnostic tool or agent. Member 170 may extend any suitable distance proximally along the shaft, but typically only the very distal portion of shaft 172 needs to be covered. The distal end 180 of member 176 or its respective band 174 is fixed or anchored to the distal end of shaft 172. The radial expansion of the band 174 is accomplished by moving the member 170 and the shaft 172 axially relative to each other. This can be achieved by moving only the shaft 172 in the proximal direction, only the member 176 in the distal direction, or both in the opposite direction. Alternatively, when made of a temperature sensitive superelastic material, the band is expanded by applying heat. In either case, as shown in FIG. 7B, the support is expanded radially distally while staying parallel to the access device 170. The fully expanded band forms each of the collective form loops in the shape of a donut with a field of view where the scope 182 is unobstructed through the central passage. Thus, a distally extending passage is established while removing, pushing away or ablating soft tissue from the distal end of shaft 172 to provide a working space and a deep view through scope 182.

  8A-8F illustrate another integrated access system 190 of the present invention that utilizes a balloon-type tissue manipulation device 194. System 190 includes an integrated scope or camera 196 that extends within main shaft 192. The manipulation balloon 194 is in fluid communication with inflation / expansion means (not shown) integrated within the shaft 192. Balloon 194 has a donut shape secured around the distal end of shaft 192 such that a central hole or opening 198 is aligned with the working channel of shaft 192. As best shown in the enlarged side and end views of FIGS. 8C and 8D, when the balloon 194 is inflated, the line of sight of the scope 196 is open and unobstructed. Depending on the flexibility of the balloon material used, the outer profile of the balloon may vary. Furthermore, a single balloon may be made up of multiple parts with varying flexibility. For materials with relatively high flexibility, the inflated balloon has a profile that is closer to that of the balloon 194 shown in FIG. 8C. With less flexible material, the balloon has a profile that is closer to that of the balloon 200 shown in FIG. 8F. In either configuration, the balloon moves the tissue and cleans the working channel / space in a manner similar to the mechanically expandable struts of the tissue manipulation members of FIGS. 7A and 7B.

  9A-9E show variations of other balloon-type tissue manipulation / access devices. The device 230 of FIG. 9 is an endoscope having a single lumen / inflation port for delivery of the scope 234 and selective expansion of the manipulation member 236 including a transparent balloon. Balloon 236 is mounted over the distal opening of lumen 232 and thus can receive and wrap the distal end of scope 234 therein. The more the balloon is expanded, the more scope 234 can extend distally within the tissue without requiring further advancement of shaft 232 into the body. In this structure, the scope is not exposed to in vivo elements unless required (detailed later with respect to FIG. 9E).

  The device 240 of FIG. 9B includes a dual lumen shaft 242. Shaft 242 may be used for delivery of other therapeutic and / or diagnostic tools and drugs in addition to dual purpose scope delivery / balloon expansion lumen 244 for delivery of scope 238 and inflation of transparent balloon 248. At least a second working channel 246. In use, the scope 238 is preferably kept proximal to the expanded balloon so that a precise incision can be made with the balloon alone. Once the incision is complete and the appropriate working / visualization space has been created, the balloon 248 can be removed if desired. On the other hand, the shaft 242 can be rotated axially as needed to adjust the position of the tissue manipulation member 248 and working channel 242.

  The device 250 of FIG. 9C has a dual lumen shaft 252 construct similar to that just described. However, the balloon manipulation member 257 extends over both openings of the channels 256,258. As a result, the balloon 257 creates a larger, more centrally located work space. An even greater difference from the previously described access devices is that tools and medication delivered through the working channel 252 cannot contact the tissue directly during use of the balloon 257. Thus, the functionality of this embodiment includes the ability to rupture or break the balloon 257. This is typically done after the tissue has been progressively removed by the balloon 257 and the scope 254 has been advanced upon reaching the intended target site. After assessing the local lesion at the target site and determining the therapy that needs to be performed, the balloon 257 may be deliberately ruptured to provide a direct assessment of the target site. Rupture may be done by using a scope 254, using a treatment device delivered through the working channel 252, or overexpanding / inflating the balloon 257. An example of a rupture means is shown in FIG. 9E in the form of a tool 270 that can be used as an expansion lumen for a balloon 272 and used for delivery of other tools. Tool 274 is provided with a relatively sharp distal tip 274 that easily punctures balloon 272.

  The scope 254 can be used for visualization after balloon rupture, but may not be necessary if treatment to the target site can be performed “blindly”. For example, if the purpose is delivery of a therapeutic agent, the expansion fluid may be the drug itself, and the drug is expanded by expanding the balloon to create a working space and then overexpanding and rupturing the balloon. The drug is used both to release the drug to the target site.

  FIG. 9D shows yet another variation of the access device 260 having an integrated balloon-type operating member 266. The shaft 262 provides a single lumen for receiving the scope 264 and expanding / inflating the balloon 266. Here, however, the scope 264 cannot be advanced beyond the distal tip of the shaft 262. Instead, a transparent tip 268 including a side port 265 is provided on the shaft lumen and the balloon 266 is expanded through the side port 265. The tip 268 may be sharp and sharp in order to function similarly to the trocar in creating a passage / work space for advancing the shaft 262. The tip 268 can also be used to rupture the balloon 266 for delivery of other tools that need to be in direct contact with the target site.

  10A-10D illustrate another access device 210 of the present invention that utilizes a transparent gelatinous material 214 held by a transparent, flexible membrane 218 for tissue manipulation. Both gels and membranes are made of biocompatible materials such as hydrogels and polyurethanes, respectively. Gel 214 is initially contained within the distal portion of the lumen used to deliver scope 216. In other variations, an extrusion function (not shown) can be used within the gel-filled lumen to advance the gel material distally. In that case, the scope can be delivered using one or more other working channels 212 provided for the delivery of diagnostic and / or therapeutic devices or drugs. In either embodiment, a gasket or other seal (not shown) can be provided in the gel lumen to prevent the gel from flowing back from the proximal end of the lumen. The membrane 218 seals and covers the distal opening of the lumen to maintain the gel 214 within the lumen, as shown in FIG. 10A.

  Upon delivery of the access device 210, the scope or extruder 216 is advanced distally when the distal end of the device is positioned at a relatively close distance of about 2 mm to about 10 mm from the target tissue site 220, thereby causing the tube Gel 214 is pushed out of the cavity. As shown in FIG. 10B, the membrane 218 is sufficiently flexible yet strong to extend distally to accommodate the extruded gel. As shown in FIG. 10C, as scope 216 advances, the gel continues to be pushed out of the device and the membrane stretches to accommodate the volume of extruded gel until the gel-filled membrane contacts tissue 220. to continue. As shown in FIG. 10D, the resistance of the tissue structure 220 to the membrane 218 can cause the trapped gel 214 to expand laterally and move fluid and other structures to enter the distal end of the scope 216. Define an enlarged visualization space. The formed visualization space provides the user with the field of view necessary for a complete assessment and analysis of local lesions adjacent to the target site 220. When direct tissue contact with other equipment is required, the gel-filled membrane itself can be displaced or manipulated by a tool delivered through the working channel 212, and thus the scope 216. Continue to provide a clear view. At the end of the procedure, the proximal contraction of the scope 216 creates a negative pressure on the gel and pulls it back into the scope lumen. Alternatively, a hole may be made in the membrane using a working tool. As a result, the gel leaks and the visualization space changes into a working space. In the latter variation, the gel can include an antibiotic or therapeutic agent to promote healing of the target site.

  In addition to creating a space distal and laterally on the tip or distal tip of an access device, delivery device, scope or other instrument, the present invention also provides space creation proximal to the device tip / distal end. To do. Various tissue manipulation mechanisms and components for creating proximal spaces can be used individually or collectively, or integrated with those used for creating lateral and distal spaces. 11A-11C are incorporated into an access / delivery tube or cannula, including the scope and many channels for therapeutic and diagnostic equipment and drug delivery, or can deliver these components or inner tube or cannula Fig. 5 shows an example of such a proximal tissue manipulation mechanism that can be used as a flexible outer sheath. In either embodiment, a proximal tissue manipulation member may be used exclusively to move or dissect tissue and / or to establish traction for an access device in use in the body.

  The access device 220 of FIG. 11A employs one, two or more wire members or hooks 224 that are laterally expandable from the distal end of the access device 220. For example, deployment may be accomplished by rotation of a knob 222 located at the proximal end of the access device attached to a pull / push wire or the like housed within the access device. The hook is moved into adjacent tissue during deployment. Thereafter, the hook may be used to pull tissue proximally from the distal end of the access device 220 to allow for improved visualization with a scope or improved access with a working tool.

  The tissue manipulation component proximal of the access device 230 of FIG. 11B is an inflatable / expandable balloon 234 that is positioned slightly proximal of the distal end of the device and is laterally expandable therefrom. Balloon 234 is in fluid communication with the inflation / expansion lumen within device 230. Similarly, the access device 240 of FIG. 11C uses a plurality of balloons 244 to manipulate tissue proximal to the distal end 240. Balloon-type embodiments may be used, similar to the hook-type embodiments described above, in that additional incisions may be made and / or provide traction by proximal translation, or traction, of the access device.

  An exemplary method of the present invention will now be described with respect to FIGS. 12A-12C in the context of accessing the intervertebral disc with a posterior or posterior lateral approach. As shown in FIG. 12A, the access device 250 includes a cannula 252 that can be used to deliver a transparent tip trocar 254 therein to create a percutaneous entry through the patient's back. Fluoroscopy can be used to facilitate this step. A very small diameter scope 256 (outer diameter less than about 1 mm) is delivered through cannula 252. The transparent tip 254 of the trocar allows visualization as the access device penetrates the skin, fat and muscle and eventually enters the spinal canal space 270 as shown in FIG. 12B, with the scope 256 therein Allows accurate placement. At this point in the procedure, the trocar can be removed from the cannula. The scope can also be removed, but if it does not block the working channel for the passage of other equipment, it can be maintained in the cannula to facilitate the remaining procedure. If the cannula 252 is made for tissue manipulation, it is maintained in the back during the procedure. Alternatively, if cannula 252 is a conventional cannula, it can simply be used to establish access within the vicinity of the target site and deliver a separate space creation device or cannula, such as device 260 shown in FIG. 12B. .

  Device 260 (or device 250) includes a scope delivery channel (as well as other working channels) and includes both a distal / lateral space creation mechanism and a proximal space creation mechanism, but only one of the two May be used. To establish traction and / or create an initial space, a proximal tissue manipulation mechanism 262 (here, in the form of a hook-type device of FIG. Deployed in proximal tissue. Pushing the actuator 266 disposed around the knob 244 mounted proximal to the cannula 260 deploys the hook 262. By rotating the knob 244, the hook 262 is tensioned and the engaged tissue is pulled back. As such, the cannula 260 is secured and a small amount of tissue adjacent to the distal end of the cannula is removed to provide a distal / lateral tissue manipulation mechanism 272 (here FIGS. 8A- Further tissue manipulation provided by the deployment of an 8E balloon-type device) is facilitated. Inflated balloon 272 moves adipose tissue, dura mater 274 and nerve root 276 within spinal canal space 270, thereby creating space 280. Distal tissue movement allows scope 278 to be advanced distally within visualization space 280 for visualizing local lesions. When assessing the area, the optimal treatment can be determined. For example, a torn disc fiber annulus 282 as shown in FIG. 12C is observed. The required tools 265, 268 (eg, blades, aspiration, cleaning, etc.) can be selected and deployed into the work space 280 through various work channels (not individually shown). The scope 278 may visualize the ring repair procedure. After the repair is complete, the instrument is removed, the tissue manipulation / space creation device is retrieved, and the access device is removed from the patient's back.

  In addition to the methods described herein or portions thereof, the present invention includes methods and / or actions that may be performed using the device of interest or by other means. All methods may include an act of providing a suitable device or system. Such provision can be made by the end user. In other words, "providing" (e.g., for a delivery system) simply requires the end user to obtain, access, approach, place, assemble, operate, power up, etc. to provide the necessary device for the intended method. . The methods detailed herein may be performed in any logically possible order of matters detailed as well as in the order of details detailed.

  Exemplary aspects of the invention are described above, with details regarding material selection and manufacture. With respect to other details of the invention, these may be understood in conjunction with the aforementioned patents and publications, and those generally known or understood by those skilled in the art. The same is true for the method-based aspects of the present invention with respect to additional actions that are commonly or logically used.

  Further, although the invention has been described with respect to several examples, selectively incorporating various features, the invention is not limited to the description or display discussed with respect to each variation of the invention. Various modifications to the described invention are possible, whether detailed herein or not included for the sake of brevity, without departing from the true spirit and scope of the present invention. Equivalents can be substituted. Further, where a range of values is provided, it should be understood that values between all upper and lower limits of the range, and any other explicitly stated values and intermediate values are Included in range.

  Also, it is contemplated that any optional feature of a variation of the described invention can be described and claimed independently or in combination with any one or more of the features described herein. Reference to a single item includes the possibility of multiple occurrences of the same item. More specifically, the singular forms “a” (indefinite article), “an (indefinite article)”, “above” and “the (definite article)” as used herein and in the appended claims are: Unless specifically stated, includes multiple objects. In other words, the use of articles permits “at least one” subject item in the above description as well as in the following claims. It is further noted that the claims may be made excluding any optional elements. As such, this description is an antecedent for the use of exclusive terms such as “simply”, “only”, etc., or the use of “negative” restrictions in connection with the recitation of claim elements. It shall function as

  Without the use of such exclusive terms, the term “comprising” in a claim means that a specific number of elements are recited in the claim or that the addition of a function delimits the nature of the element as recited in the claim. The inclusion of any additional elements shall be allowed regardless of whether they can be considered to change. Except as otherwise defined herein, all technical and scientific terms used herein shall be given the broadest possible meaning generally understood while maintaining the validity of the claims. And

  The breadth of the present invention is not limited to the examples provided and / or the specification, but only by the scope of the claims.

It is a posterior side view of two vertebral bodies. FIG. 2 is a coronal view of the anatomy of a healthy intervertebral disc and surrounding spine. FIG. 5 is a coronal view of a herniated disc. FIG. 4 is various views of an embodiment of an access device of the present invention used in a preformed wireframe type operating device of the present invention, with the operating device shown in an undeployed and deployed state. FIG. 4 is various views of an embodiment of an access device of the present invention used in a preformed wireframe type operating device of the present invention, with the operating device shown in an undeployed and deployed state. FIG. 4 is various views of an embodiment of an access device of the present invention used in a preformed wireframe type operating device of the present invention, with the operating device shown in an undeployed and deployed state. FIG. 4 is various views of an embodiment of an access device of the present invention used in a preformed wireframe type operating device of the present invention, with the operating device shown in an undeployed and deployed state. FIG. 2 is a longitudinal and cross-sectional view of an access device using an operating device of the present invention that includes a preformed wireframe / balloon combination, with the operating device shown in an undeployed and deployed state. FIG. 2 is a longitudinal and cross-sectional view of an access device using an operating device of the present invention that includes a preformed wireframe / balloon combination, with the operating device shown in an undeployed and deployed state. It is the vertical and horizontal sectional view of the access device using the free form wire type operation device of the present invention, and the operation device is shown in an undeployed state and an unfolded state. It is the vertical and horizontal sectional view of the access device using the free form wire type operation device of the present invention, and the operation device is shown in an undeployed state and an unfolded state. FIGS. 4A and 4B are various views of an access device using a wire manipulation device having a preformed spiral or coil shape, with the manipulation device shown in an undeployed and deployed state. FIGS. 4A and 4B are various views of an access device using a wire manipulation device having a preformed spiral or coil shape, with the manipulation device shown in an undeployed and deployed state. FIGS. 4A and 4B are various views of an access device using a wire manipulation device having a preformed spiral or coil shape, with the manipulation device shown in an undeployed and deployed state. Figure 2 is an undeployed state of another coil-type tissue manipulation device of the present invention integrated with an access device of the present invention. Figure 3 is a deployed state of another coil-type tissue manipulation device of the present invention integrated with the access device of the present invention. Figure 5 is an undeployed state of yet another loop type tissue manipulation device of the present invention integrated with an access device of the present invention. Figure 5 is a deployed state of yet another loop type tissue manipulation device of the present invention integrated with an access device of the present invention. Figure 2 is an undeployed state of a balloon-type tissue manipulation device of the method of the present invention integrated with an access device. Figure 3 is a deployed state of a balloon-type tissue manipulation device of the method of the present invention integrated with an access device. It is a side view of an operation device. It is an end view of an operation device. It is a side view and end view of the operating device. It is a side view of the operation device changed a little. 6 is a variation of another balloon-type access and manipulation device of the present invention. 6 is a variation of another balloon-type access and manipulation device of the present invention. 6 is a variation of another balloon-type access and manipulation device of the present invention. 6 is a variation of another balloon-type access and manipulation device of the present invention. This is a mode in which the balloon manipulation device of the present invention can be deployed. Figure 2 is a gel-based manipulation device of the present invention in various deployment actions and uses. Figure 2 is a gel-based manipulation device of the present invention in various deployment actions and uses. Figure 2 is a gel-based manipulation device of the present invention in various deployment actions and uses. Figure 2 is a gel-based manipulation device of the present invention in various deployment actions and uses. 2 is various embodiments of the proximal tissue movement feature of the present invention. 2 is various embodiments of the proximal tissue movement feature of the present invention. 2 is various embodiments of the proximal tissue movement feature of the present invention. FIGS. 11A and 11B are various views of an embodiment of a method for performing a treatment in a region of the spine utilizing the tissue manipulation device of FIGS. 8A-8E and the proximal tissue transfer device of FIG. FIGS. 11A and 11B are various views of an embodiment of a method for performing a treatment in a region of the spine utilizing the tissue manipulation device of FIGS. 8A-8E and the proximal tissue transfer device of FIG. FIGS. 11A and 11B are various views of an embodiment of a method for performing a treatment in a region of the spine utilizing the tissue manipulation device of FIGS. 8A-8E and the proximal tissue transfer device of FIG.

Claims (19)

A system for accessing a target site in the body, the system comprising:
A cannula having at least one lumen;
A scope deliverable through the at least one cannula lumen;
At least one strut deployable from a distal portion of the cannula, the deployment of the at least one strut creating a space in tissue adjacent to the distal portion of the cannula, the space being the scope A system, including struts, that facilitates visualization.   The system of claim 1, wherein the at least one strut is deployed distal to the distal portion of the cannula.   The system of claim 1, wherein the at least one strut is deployed laterally of the distal portion of the cannula.   The system of claim 1, wherein each strut defines a loop when deployed.   The system of claim 1, wherein the at least one strut defines a helix or coil when deployed.   The system of claim 1, wherein the at least one strut defines a frame when deployed.   The system of claim 1, further comprising a plurality of struts, the struts defining a donut shape having a central opening when deployed, and having a field of view through which the scope is unobstructed through the central opening. A system for accessing a target site in the body,
A cannula having at least one lumen;
A scope deliverable through the at least one cannula lumen;
A wire deployable from a distal portion of the cannula, the deployment of the wire creating a space in tissue adjacent to the distal portion of the cannula, the space facilitating visualization by the scope; System including wire.   The system of claim 8, wherein the wire is deployed distal to the distal portion of the cannula.   The system of claim 8, wherein the wire is deployed to the side of the distal portion of the cannula.   The system of claim 8, wherein the wire defines a loop when deployed.   The system of claim 8, wherein a size of the loop is adjustable.   The system of claim 8, wherein the wire defines a helix or coil when deployed.   The system of claim 8, wherein the wire defines a frame when deployed.   The system of claim 8, wherein the frame is disposed approximately lateral to the distal end of the scope.   The system of claim 8, wherein a distal end of the wire is free.   The system of claim 16, wherein a distal end of the wire is secured to the cannula.   The system of claim 8, wherein at least one end of the wire is secured to the cannula.   The system of claim 8, wherein the wire comprises NITNOL.

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