JP5175264B2 - Apparatus and method for modifying tissue - Google Patents

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a US Provisional Application No. 11 / 375,265 entitled “Methods and Apparatus for Tissue Modification” filed March 13, 2006 (Attorney Docket No. 026445-000700US), 2006. US Provisional Application No. 11 / 405,848 (Attorney Docket No. 026445-000720US) entitled “Mechanical Tissue Modification Devices and Methods” filed on April 17, 2006, “Powered” filed on April 17, 2006 US Provisional Application No. 11 / 406,486 (Attorney Docket No. 026445-000721US) entitled "Tissue Modification Devices and Methods", United States of America entitled "Tissue Modification Barrier Devices and Methods" filed April 17, 2006 Provisional Application No. 11/405, 859 (Attorney Docket No. 026445-00 0722), and claims priority to US Provisional Application No. 11 / 429,377 (Attorney Docket No. 026445-000723US) entitled “Flexible Tissue Rasp” filed on May 4, 2006. The disclosures of all the aforementioned references are incorporated herein by reference.

  The present invention relates to a method and apparatus for modifying a patient's tissue.

  Many pathological states of the body are caused by body tissue growth, movement, replacement, and / or various other changes that cause body tissue to compress (or “impact” one or more other normal tissues or organs). give"). For example, a cancerous tumor compresses adjacent organs and adversely affects the function and / or health of the organ. In other cases, bone growth (or “osteophytes”), changes in bone and / or soft tissue arthritis, excess soft tissue, or other abnormally hypertrophic bone or soft tissue conditions may be present in nearby nerve and / or vascular tissue. Affecting one or more nerve functions, reducing vascular blood flow, or both. Other examples of tissue that proliferates or moves and compresses adjacent tissue include ligaments, tendons, cysts, cartilage, scar tissue, blood vessels, adipose tissue, tumors, hematomas, and inflammatory tissue.

  One particular example of a condition caused by tissue erosion is spinal stenosis. Spinal stenosis occurs when nerve tissue and / or vascular tissue in the spinal cord is eroded by one or more structures that compress it ("nervous and / or neurovascular erosion"). cause. Tissue erosion can occur in the spinal cord, such as the central spinal canal (vertical passage through which the spinal cord and tail are passed), the lateral fovea of the spinal cord, or one or more intervertebral foramen (openings through which nerve roots branch off the spinal cord) It occurs in several different areas.

  For illustration purposes, FIG. 1 shows a vertebra (one of the spine bones) with a horsetail (a bundle of nerves shaped like a horse's tail extending from the base of the spinal cord through the center of the spinal cord) shown in cross-section. And a schematic plan view of two nerve roots that exit the central spinal canal and extend through the intervertebral foramen on both sides of the vertebra (Figure 1 is not drawn to scale) It is intended for illustrative purposes only, and it is emphasized here that the drawings attached to this application are not intended for anatomical accuracy, but are exemplary purposes for ease of explanation. Should.) The spinal canal and horsetail run vertically in the central spinal canal along the spinal cord, while the nerve root diverges from the neural tube and the caudad of the adjacent vertebral canal extends through the intervertebral foramen.

  A common cause of spinal stenosis is buckling and thickening of the yellow ligament (one of the ligaments attached and connected to the vertebra), as shown in FIG. The buckling and thickening of the ligamentum flavum affects one or more neurovascular structures, dorsal root ganglia, nerve roots, and / or the spinal cord itself. Another common cause of nerve and neurovascular compression in the spine is one or more intervertebral disc (soft discs between adjacent vertebrae), which cause disc disruption, protrusion, or hernia. In FIG. 1, the intervertebral disc is indicated by three arrows, clearly showing that the intervertebral disc protrudes into the central spinal canal or becomes hernia and strikes the spinal cord, the tail and / or individual nerve roots. . Other causes of nerve and neurovascular collisions in the spinal column include enlargement of one or more facet joints (also known as spinal joint processes, which provide joints between adjacent vertebrae, Vertebral upper glenoid processes are shown in FIG. 1), formation of bone growth on the vertebrae (bone growth or “bone spine”), spondylolisthesis (sliding of one vertebra with respect to an adjacent vertebra), And (face joint) synovial cysts. Intervertebral discs, bones, ligaments or other tissues affect the spinal cord, cauda equina, branching spinal nerves and / or blood vessels in the spinal cord, reduced function, ischemia (insufficient blood supply), and neural or neurovascular tissue Cause even permanent damage. For the patient, this manifests itself as pain, abnormal sensations, and / or loss of strength or movement.

  In the United States, spinal stenosis occurs in 4% to 6% of adults over the age of 50, which is the most common reason for the aforementioned lumbar surgery for patients over the age of 60. Traditional approaches to the treatment of spinal stenosis symptoms include systemic drug treatment and physical treatment. Epidural steroid injections are also used, but do not provide a ling lasting benefit. When these approaches are inadequate, current treatment of spinal stenosis removes spinal ligaments, cartilage, osteophytes, synovial cysts, cartilage, and bone to increase space for nerve and neurovascular tissue Limited to surgery. Standard treatments for the treatment of spinal stenosis include laminectomy (complete removal of one or more vertebral plates (see FIG. 1)) followed by removal of the ligamentum flavum ("resection") or vertebrae Archectomy (partial removal of the board) is included. In addition, surgery includes partial or occasional complete spine arthrotomy (removal of all or part of one or more facet joints between vertebrae). Curved discs cause nerve collisions and disc components are surgically removed during discectomy.

  The removal of the vertebrae caused by laminectomy and spine arthrotomy leaves a highly inappropriate spine-generated area, further damage to the patient's vertebrae, and limit the patient's ability to operate Additional fixation procedures are required. In spinal fusion, several types of support mechanisms are attached to the vertebrae to prevent the vertebrae from moving relative to each other and allow adjacent vertebrae to be fixed. Unfortunately, surgical spinal fixation reduces the ability of the fixed part of the spine to move, reduces the patient's range of motion, and compresses the intervertebral discs and facet joints of adjacent vertebral parts.

  While laminectomy, spinectomy, discectomy, and spinal fixation often improve symptoms of nerve and neurovascular collisions in a short time, these procedures are very invasive and spinal function , Significantly disrupting normal anatomy, and increasing the long-term morbidity seen in patients not treated as described above.

  Accordingly, a non-invasive method and apparatus that resolves nerve and neurovascular collisions within the vertebra is desired. Ideally, the method and apparatus for resolving nerve and neurovascular collisions in the vertebrae utilizes one or more target tissues and prevents unwanted effects on adjacent or nearby non-target tissues. Also, ideally, such methods and devices are slightly invasive and reduce collisions without removing significant amounts of vertebrae, joints, or other spinal pointing structures, thereby fixing the spinal column And ideally reduces the extent of long-term conditions caused by currently available surgical procedures. A non-invasive method and apparatus that modifies the target tissue of a part of the body rather than the vertebra without modifying the non-target tissue is advantageous. At least some of these objectives will be met by the present invention.

  Background technology. Flexible wire saws, such as threadwire (T saw) and Gigli saws, chain saws have been used since the late 1800s to cut bones and other tissues of the body. See, for example, Brunori A et al. "Celebration g the Centenial (1984-1994): Leonardo Gigli and His Wire Saw," J Neurosurg 82: 1086-1090, 1995. An example of such a saw is described in US Pat. No. 8,250, issued Nov. 28, 1876 to P.A. Stohlmann. An explanation of cutting vertebrae using a T-saw is found in Kawara N et al. “Recapping T-Saw Laminoplasty for Spinal Cord Tumors,” SPINE Volume 24, Number 12, pp. 1363-1370.

  Methods and devices for treating spinal stenosis are described, for example, in US Patent Applications 2006/0264994 and 2004/0122459, International Patent Application WO 01/08571. A surgical instrument for removing cartilage from the knee cavity is described in US Pat. No. 3,835,859.

  In various embodiments, the present invention provides methods, apparatus and systems for modifying patient tissue. In general, the method, apparatus, and system require an elongated, at least flexible tissue modification device that includes one or more tissue modification members that modify one or more target tissues. The tissue modification device includes one or more tissue modification devices configured to prevent or prevent damage to non-target tissue when the tissue modification member (or tissue modification members) are in a position to modify the target tissue. Sides, surfaces or portions may be configured to contact non-target tissue. In various embodiments, during the process of modifying tissue, the fixation force and / or tension is applied to or near the distal or proximal portion of the tissue modification device inside or outside the patient. Also, tension or tension is applied to the opposite end of the device, pressing the tissue modifying member against the target tissue. The tissue modifying member then operates to modify the tissue while not significantly extending proximally or distally beyond the target tissue. In some embodiments, the tissue modifying member is positioned along the length of the tissue modifying device that is approximately the same as the length of the target tissue to be modified.

  By “applying a fixing force” is meant that a force is applied such that a portion of the device or the entire device is substantially stable or free to operate. Thus, applying a fixing force is not limited to preventing all operation of the device, and in fact, in some embodiments, the device applying the fixing force moves in one or more directions. In other embodiments, the securing force is applied to substantially stabilize a portion of the device, while other portions of the device can move more freely. As will be described in more detail below, applying a fixing force in one embodiment requires a user of the device to grip the end of the device or near it. In other embodiments, the device may apply a securing force using one or more securing members. In many embodiments, the fixation force is applied by or against one or more tissues of the patient's body, and the tissue often moves to apply (or assist) the force. Thus, applying a fixing force to the device again does not necessarily mean that all movements of the device are removed. Of course, in some embodiments it is possible and desirable to remove all or nearly all movement of the device (or part of the device), and in some embodiments, A fixing force is used to do that.

  The methods, devices, and systems of aspects of the present invention typically modify tissue while preventing undesirable modification or damage to surrounding tissue. Applying tension to the tissue modification device by applying a fixation force at or near one end and applying tension at or near the opposite end strengthens and limits the tissue modification member of the device. Function effectively within the therapeutic range. By applying tension to a very flexible device, the device profile can be made relatively small, which is advantageous for non-invasive procedures and alternative solutions for the target tissue. Facilitates the use of the device in other treatments.

  In this application, the terms “modify tissue” or “tissue modification” refer to tissue cutting, removal, peeling, shrinking, burning, melting, cooling, heating, freezing, dispensing, polishing, stent insertion, or movement, etc. Including, but not limited to, suitable modifications. In some embodiments, the described methods, devices and systems are used to modify tissue in the spinal column, such as for the treatment of nerve collisions, neurovascular collisions, and / or spinal stenosis. It is done. In alternative embodiments, target tissue in other parts of the body may be modified.

  In one aspect of the invention, an apparatus for modifying one or more tissues of a patient includes an at least partially flexible elongated body having a proximal portion and a distal portion, and a length of target tissue to be treated. A tissue modifying member disposed along one side of the body to have a limited length substantially the same as the atraumatic surface disposed near the tissue modifying member to face a non-target tissue. And an actuating portion coupled to the tissue modifying member, extending to a proximal portion of the body, and actuating the tissue modifying member without significantly moving the elongated body proximally or distally. Means for easily applying at least one of tension or fixation force at or near the proximal and distal portions of the elongated body to move the tissue modifying member relative to the target tissue; Have. In some embodiments, the flexible portion of the elongate body may extend through the intervertebral space of the patient's spinal column while the proximal and distal portions of the device extend outside the patient's body. The tissue modifying member may be configured to extend and may be configured to remove at least one of soft tissue or bone to treat or alleviate spinal stenosis.

  In some embodiments, the elongate body has a width of 5 mm or less at any location along its length. In some embodiments, the elongate body is a guide wire connector, guide wire lumen, rail, track, or longitudinal impression along which the device passes over the delivery device. Or at least one of the longitudinal recesses pulled behind the delivery device. In some embodiments, the tissue modifying member may be disposed along the length of the body that is 3 cm or less in length.

  Examples of tissue modifying members incorporated into the device include Ronjoules, Curettes, scalpels, one or more cutting blades, scissors, forceps, probes, demon files, files, abrasive members, one or more small surfaces, electrosurgery Includes surgical device, bipolar electrode, monopolar electrode, thermal electrode, rotary power mechanism shaver, reciprocating power mechanism shaver, power mechanism burr, laser, ultrasonic crystal, cryogenic probe, and pressurized water jet However, it is not limited to these. In one embodiment, the tissue modifying member may comprise two opposing blades, at least one of which moves to unite the blades and cut the target tissue. In some embodiments, the tissue modifying member may be positionable outwardly from an opening on the elongated body.

  In some embodiments, the means for applying force may comprise proximal and distal handles configured to easily apply force from outside the patient, wherein at least one of the proximal or distal handles One may be removably attached to the elongated body. Optionally, some embodiments further comprise at least one protective member removably coupled to the elongate body to prevent damage to non-target tissue during a tissue modification procedure. Also good. Optionally, some embodiments may further comprise a tissue collection chamber housed within or coupled to the elongate body.

  In another aspect of the invention, a system for modifying one or more tissues in a patient's spinal column may comprise a tissue modification device, at least one guide wire, and instructions for use. The tissue modification device includes an elongated body that is at least partially flexible having a proximal portion and a distal portion, and a limited length that is approximately the same as the length of the target tissue to be treated. A tissue modifying member disposed along one side, an atraumatic surface disposed near the tissue modifying member to face the non-target tissue, and connected to the tissue modifying member, near the body. An actuating portion extending to a position and actuating the tissue modifying member without significantly moving the elongated body proximally or distally; and moving the tissue modifying member relative to the target tissue To this end, it may comprise means for easily applying at least one of tension or securing force at or near the proximal and distal portions of the elongated body.

  In some embodiments, the system may comprise a plurality of tissue modification devices. In some embodiments, the system may include an extension and an introducer sheath through which the tissue modification device is advanced into the patient's body.

  In another aspect of the present invention, a device for modifying tissue in the spinal column has a distal portion and a proximal portion that are sized to pass between a target tissue and a non-target tissue within the epidural space of the spinal column. A distal end of the shaft that extends from a distal portion of the shaft and is configured to easily apply at least one of a securing force or tension to the shaft; and a distal end of the shaft A movable tissue correction member connected to the shaft at or near the position, a drive member connected to the tissue correction member, and a power transmission member connected to the drive member Good. In some embodiments, a flexible portion of the distal portion of the shaft extends through an intervertebral foramen of a patient's spinal column, and the proximal portion of the shaft and the distal force are applied. You may comprise so that the member to add may extend outside a patient's body. In some embodiments, the tissue modification member may be configured to remove at least one of soft tissue or bone to treat or alleviate spinal stenosis.

  Some embodiments further include a proximal force coupled at or near the proximal portion of the shaft and configured to easily apply at least one of a securing force or tension to the shaft. You may provide the member to add. In some embodiments, for example, the proximal force applying member may comprise a handle. Optionally, such an embodiment may further comprise an actuating portion coupled to the handle and actuating the at least one drive member.

  In some embodiments, the distal portion of the shaft may have a width of 7 mm or less. In some embodiments, the distal portion of the shaft may have a height of 2 mm or less. In some embodiments, the distal force applying member may comprise a distal extension of the shaft. Optionally, the member applying the distal force may further comprise a removable handle connectable to the distal extension.

  In some embodiments, the shaft may further comprise an opening in the distal portion, and the tissue modifying member may modify tissue through the opening. Optionally, some embodiments may include a visualization member disposed at or near the distal portion of the shaft to facilitate visualization of the tissue being modified. Some embodiments further include, but are not limited to, a cleaning liquid lumen, a suction lumen, a combined cleaning / aspiration lumen, a guidewire lumen, a fiber optic lumen, a lumen for passing one or more visualization devices, the power There may be at least one lumen extending through the shaft, such as a lumen for passing the transmission member and a lumen for passing one or more steering members.

  In various alternative embodiments, the power transmission member may comprise one or more radio frequency, ultrasonic, laser, microwave, water, heat, and cold power transmission members. In some embodiments, the distal portion of the shaft includes a tissue protective surface disposed near the tissue modification member to prevent undesirable damage to non-target tissue during a tissue modification procedure. It may be provided. Some embodiments may further comprise at least one barrier device slidably coupled to the shaft to prevent undesired damage to non-target tissue during a tissue modification procedure. Further, some embodiments may include at least one electrode coupled to the tissue protective surface or the barrier device to stimulate tissue that contacts the tissue protective surface or the barrier device. In some embodiments, the shaft may include a hollow chamber at or near its distal end to collect the removed tissue.

  In another aspect of the invention, an apparatus for modifying tissue within a patient's body includes at least a portion having a distal portion and a proximal portion that are sized to pass between the target tissue and non-target tissue of the patient. And a flexible elongated body coupled to a proximal portion and a distal portion of the elongated body, and configured to easily apply at least one of fixing force and tension to the elongated body. A member for applying proximal and distal forces; a movable tissue modifying member coupled to the elongated body; a drive member coupled to the tissue modifying member; and a power transmission member coupled to the drive member. May be included. In some embodiments, the size of the elongate body allows the flexible portion of the body to extend through the intervertebral foramen of the patient's spinal column and the proximal portion of the device And the distal portion may extend outward from the patient. Also, in some embodiments, the tissue modifying member may be configured to remove at least one of soft tissue or bone to treat or alleviate spinal stenosis.

  In some embodiments, the proximal and distal force applying members may each comprise a handle, and at least one of the handles may be removable. Some embodiments may further comprise an actuating portion coupled to one of the handles to actuate the drive member. In some embodiments, the size of the elongate body may allow at least a portion of the body to pass through the intervertebral foramen of the patient's spinal column.

  In another aspect of the invention, a device that prevents undesired damage to a patient's tissue during a tissue modification procedure protects non-target tissue from a contracted state that facilitates passage into the patient's body. At least one shape-changing portion capable of changing to an expanded expanded state, and a low profile extending from the shape-changing portion to facilitate passage of the barrier device through the patient's body At least one elongate portion having a length sufficient to extend from an opening in the patient's skin to a region of target tissue and non-target tissue or in the vicinity thereof; and the barrier exceeds at least one guide member And at least one guide feature extending along at least a portion of the barrier to allow passage through the patient's body. Generally, the barrier device has a total length sufficient to pass between a target tissue and a non-target tissue from a first opening on the patient's skin.

  In some embodiments, the device can extend from a first opening on the patient's skin and between target and non-target tissue in the spinal column within the epidural space of the patient's spinal column. It may have a total length, size, and configuration. In some embodiments, the total length of the device extends from the patient's body through the first opening between the target tissue and the non-target tissue, and the total length of the device on the patient's skin. A device characterized by being long enough to be able to exit the patient through two openings.

  In some embodiments, the at least one elongate portion extends from a proximal elongate portion extending from a proximal end of the shape changing portion and a distal end of the shape changing portion. A distal elongate portion. In some embodiments, the device may further comprise a barrier delivery sheath through which the barrier device is passed into the patient's body. In some embodiments, the portion that changes shape may automatically change shape as it leaves the barrier delivery device. In another embodiment, the device may further comprise at least one actuating part connected to the part that changes shape and changing the part from a contracted state to an expanded state.

  In some embodiments, the at least one guide shape is selected from the group consisting of a guidewire lumen, a split lumen, a rail, a track, and a longitudinal recess. In some embodiments, at least one guide shape is configured to facilitate guidance of one or more tissue modification devices along the barrier member. Some embodiments may further comprise at least one conductive electrode coupled to the barrier device to deliver current to at least one of the target tissue or non-target tissue. The apparatus may further comprise at least one monitoring device for monitoring the effect of the current on the tissue, the monitoring device comprising an electromyography (EMG) monitoring device and somatosensory evoked potential (SSEP) monitoring. Selected from the group consisting of devices.

  In some embodiments, the portion of the barrier device that changes shape may comprise a front surface facing a tissue modification device for performing a procedure in the spinal column and a back surface facing a non-target tissue. In some embodiments, the shape changing portion may be selected from the group consisting of an expandable scaffold, a hydrogel material, a wire mesh, an expandable stent, and an inflatable bag. .

  In another aspect of the invention, an apparatus for modifying tissue in a patient's spinal column to treat or alleviate spinal stenosis comprises an at least partially flexible elongated body having a proximal portion and a distal portion. A main body, a polishing surface disposed along a part of one side of the elongated main body, and the polishing surface when facing the target tissue, the polishing surface is disposed so as to face the non-target tissue. A non-abrasive surface disposed near the polishing surface and coupled to the elongate body at or near the proximal portion to facilitate applying and transmitting tension to the elongate body. A proximal tension member coupled to the elongated body at or near the distal portion to facilitate applying and transmitting tension to and from the elongated body; And a distal tension member that is not directly coupled to.

  In one embodiment, the elongated body may have a width of 5 mm or less and a height of 2 mm or less. In some embodiments, the elongate body is a guide wire connector, guide wire lumen, rail, track, or longitudinal impression along which the device passes over the delivery device. Or a longitudinal indentation that is pulled behind the delivery device. In some embodiments, the proximal and distal tension members may comprise handles, and at least one of the handles may be removably attached to the elongate body. In another embodiment, at least one of the proximal and distal tension members may be positionable from within the elongated body.

  Some embodiments may further comprise at least one protective member coupled to the elongate body to protect the non-target tissue from damage during a tissue modification procedure. In some embodiments, at least one securing device may be included to secure the protection member outside the patient's body. In some embodiments, the fixation device may comprise proximal and distal fixation devices removably coupled to the protective member at or near their proximal and distal portions. . In some embodiments, the protective member may include at least one opening along its length through which the polishing surface is exposed to modify the target tissue. Optionally, some embodiments may further comprise at least one electrode coupled to the protection member to inspect the position of the protection member. Optionally, some embodiments comprise at least one electrode coupled to the tissue modification device at or near the polishing surface and / or the non-polishing surface to inspect the device. Also good. In some embodiments, the device may also include at least one lumen within the elongate body to provide at least one of aspiration and cleaning.

  In another aspect of the invention, an apparatus for modifying tissue in a patient's spinal column to treat or alleviate spinal stenosis has a proximal portion, a distal portion, and at least one opening along the length. An elongate protective member that is at least partially flexible, and an at least partially flexible elongate tissue modifying member that is at least partially disposed within the protective member, wherein the elongate protective member is distant from the proximal portion. A tissue modifying member comprising a position and at least one abrasive surface; and at or near the proximal portion of at least one of the protective member and the tissue modifying member to easily apply tension in a first direction At least one proximal tension member provided on the distal end of the protective member and at least one distal portion of the tissue modifying member for easily applying tension in the second direction. Connected directly to the proximal tension member And tensile member of at least one distal There may comprise a.

  In another aspect of the invention, a method of modifying a patient's tissue advances an at least partially flexible elongated tissue modification device between a target tissue and a non-target tissue in the patient's body; Positioning the tissue correction member of the tissue correction device close to the target tissue so that the tissue correction member faces the target tissue and not the non-target tissue; and tension is applied to the tissue correction device. In addition to moving the tissue modifying member relative to the target tissue in addition to or near the distal and proximal portions, and during modifying the tissue, the tissue modifying member extends beyond the target tissue. A step of modifying the target tissue using the tissue modification member while preventing significant extension toward the proximal or distal portion of the tissue modification device. And up, it may comprise a.

  In some embodiments, the step of advancing the tissue modification device causes the flexible portion of the device to be attached to the patient so that the proximal and distal portions of the device extend outside the patient's body. It may be advanced into the epidural space via the vertebral groove. In some embodiments, advancing the tissue modification device may advance the flexible portion through the intervertebral foramen along a curved path. In some embodiments, modifying the target tissue may remove at least one of soft tissue or bone to treat or alleviate spinal stenosis.

  These and other aspects and embodiments are more fully described in the following detailed description with reference to the accompanying drawings.

  Methods, devices and systems for modifying tissue within a patient are provided. Although the following description and accompanying drawings generally focus on modifying tissue within the spinal column, in various alternative embodiments, various tissues at various anatomical locations on the patient may be considered. It may be corrected.

  With reference to FIG. 2, in one embodiment, the tissue modification device 102 includes an elongated body 108 having a proximal portion 107 and a distal portion 109, and a handle 104 having an actuation portion 106 coupled to the proximal portion 107. One or more tissue correction members 110 and one or more protective surfaces 112 are provided. In various embodiments, some of these are described further below, and the modification device 102 is introduced into the area to be treated, such as the spine, using a variety of introduction methods, devices and systems. In FIG. 2, for example, the correction device 102 extends through a first incision 240 in the patient's back and through an introducer device 114 placed in the central spinal canal. The correction device 102 advances along the guide member 116 and extends through the introducer member 114, through the intervertebral foramen and between two adjacent vertebrae (only one vertebra is shown in FIG. 2). And exit the second (or “distal”) incision 242 in the back. In some embodiments, as shown, the guide member has an angled distal tip 117 to facilitate the advancement of the guide member 116 through tissue.

  In general, the tissue modification device 102 is advanced to a position within the spinal column such that the tissue modification member 110 faces the target tissue to be modified, such as the curved, thick, or protruding ligamentum tissue shown in FIG. The correction device 102 is configured so that the protective surface 112 faces the non-target tissue when the tissue correction member 110 faces the target tissue. The protective surface 112 may simply be the length of the elongated body 108 or may be one or more protective shapes such as an expanded diameter, a protective or smooth coating, a deployable barrier, a drug eluting coating or a port. In some embodiments, protective surface 112 functions as a “do not modify tissue” surface and does not substantially modify non-target tissue. In alternative embodiments, the protective surface 112 may be applied in several positive ways, such as by administering one or more protective agents, applying one or more energy forms, or providing a physical barrier. Protecting may affect non-target tissues.

  In some embodiments, when the tissue modification device 102 is positioned such that the tissue modification member 110 faces the target tissue and the protective surface 112 faces the non-target tissue, the fixation force is applied within or outside the patient. At or near the distal portion 109 of the elongated body 108. Tension is also applied to or near the proximal portion 107 of the elongate body 108, such as by pulling on the handle 104 (unidirectional arrow), and using the actuator 106 (bidirectional arrow) to modify tissue. Actuate member 110 to modify the target tissue. In the illustrated example, a securing force is applied near the distal portion 109 by the user's hand 244 and the handle 104 is pulled proximally (arrow) to apply tension. In an alternative embodiment, the hand 224 grips at or near the distal portion 117 of the guide member 116 thereby applying a locking force and applying a locking force to the elongated body 108. In such an example position change, the elongate body 108 or handle 104 may optionally be tightened to the guide member 116 to enhance or facilitate applying a securing force to the elongate body 108. Good. For tissue correction by the tissue correction member 110, cutting, removal, incision, repair, blood flow reduction, reduction, shaving, burring, biting, remodeling, biopsy, debridement, dissolution, weight loss, polishing , Sanding, planing, heating, cooling, evaporation, delivering a drug to the target tissue, and / or retracting the target tissue. Once the tissue is modified, the tissue modification device 102 and any introducer device 114, guide member 116, or other device is removed from the patient.

  In various embodiments of the device, the tissue modification member 110 is disposed along the body 108 of any suitable length. In one embodiment, such as the Nichigochi embodiment used in spinal column treatment, the tissue modifying member 110 is along the length of the device of 10 cm or less, preferably 6 cm or less, more preferably 3 cm or less. Arranged. In various embodiments, the tissue modification member 110 may be a long joule, a curette, a scalpel, one or more cutting blades, scissors, forceps, a probe, a demon eye file, a file, an abrasive member, one or more small surfaces, an electrosurgical procedure. Device, bipolar electrode, monopolar electrode, thermal electrode, rotary power mechanism shaver, reciprocating power mechanism shaver, power mechanism burr, laser, ultrasonic crystal, cryogenic probe, pressurized water jet, dosing member, A needle, a needle electrode, or a combination thereof may be provided. In various embodiments, all tissue modifying members 110 may be movable relative to the elongated body, may all be stationary, or may be partially movable and partially stationary. . These and other aspects and examples are further described below.

  Turning now to 3I from FIGS. 3A, a more detailed view of one embodiment of the tissue modification device 102 is shown. Referring to FIG. 3A, the tissue modification device 102 is exposed by an elongated body 108 having a proximal portion 107 and a distal portion 109, an opening 111 disposed along the elongated body 108, and a window 111. And includes a tissue modification blade 110 and a handle 104 having an actuating portion 106 coupled to the proximal portion 107. In the illustrated embodiment, the tissue modifying member comprises a blade 110, but in alternative embodiments, other tissue modifying members may be added or replaced.

  In various embodiments, the elongated body 108 may have various sizes, shapes, profiles, and degrees of flexibility. For example, a curved shaped distal portion 109 is shown and at least a portion of the elongated body 108 is shown to be flexible. In various embodiments, the elongate body 108 may have one or more of circular, oval, elliptical, flat, warped flat, rectangular, square, triangular, symmetric or asymmetric cross-sectional shape. As shown in FIGS. 3C and 3D, in the illustrated embodiment, the elongate body 108 has a relatively flat configuration to facilitate placement of the body 108 between target and non-target tissue. To. The distal portion 109 of the body 108 is tapered to facilitate passage through confined spaces and incisions in the patient's skin. The body 108 also includes a slightly expanded portion around the opening 111 and blade region. In one embodiment, such as a practical example used to modify tissue in the spinal column, the body 108 has a height of 10 mm or less at any position along the length and 20 mm or less at any position along the length. Or, more preferably, a small profile having a height of 2 mm or less at any position along the length and a width of 4 mm or less at any position along the length. The body 108 extends between the target tissue and the non-target tissue through the first incision in the patient and is long enough to exit from the second incision in the patient. Alternatively, the body 108 may extend a fixed location within the patient's body between the target tissue and the non-target tissue through the first incision. In another alternative embodiment, the body 108 extends through the first incision near the patient's body between the target tissue and the non-target tissue but distally from the target tissue. In addition, a part of the tissue correction device 102 is fixed to the guide member 116. In some embodiments, the elongated body 108 has at least positional features that allow the body to pass over a guidewire or other guide member, or to allow one or more guide members to pass over or within the body 108. It has. For example, in various embodiments, the body 108 may have one or more guidewire lumens, rails, tracks, longitudinal depressions, or combinations thereof.

  In one embodiment, the elongate body 108 is primarily flexible along its length, and is a suitable flexible material such as a thin and flexible metal, plastic resin, fabric, etc. It has. In some embodiments, the elongated body 108 is provided to provide a pushing ability to a portion of the body 108 or to apply force to the tissue modifying member 110 without causing undesirable bending or twisting of the elongated body 108. It may be beneficial to have one or more hard parts. In such embodiments, the strength is provided by adding material to the body 108, or by thickening or widening the hard part, or by taking a different shape.

  The handle 104 may have any suitable configuration according to various embodiments. Similarly, the actuating portion 106 may comprise many actuating portions of various embodiments. In the embodiment shown in FIG. 3A, the actuator 106 includes a trigger or moving handle portion that is grasped by the user and pulled or pushed toward the handle 104 to unite the blade 110 and cut tissue. . In an alternative embodiment, the actuator 106 may alternatively include a switch or button that activates a radio frequency surgical ablation tissue modification member. In yet another embodiment, the actuator 106 may comprise a trigger and switch combination, one or more pull wires, any shape lever, and / or combinations thereof.

  3B to 3D show a part of the tissue correction device 102 in detail. In these figures, the opening 111 and the blade 110 are more clearly shown. In one embodiment, at least one of the elongate body 108 and the blade 110 has a slightly curved configuration. In alternative embodiments, at least one of the elongated body 109 and the blade 110 may be flat. In other alternative embodiments, a tissue modifying member such as blade 110 may be raised relative to the elongated body 108.

  The blade 110 includes a distal blade 110a and a proximal blade 110b at the distal and proximal ends of the opening 111 of the elongate body 108, respectively. The opening 111 in the body 108 accommodates both soft and hard tissue when the device is forced against the surface of the target tissue site. The plan view of the distal portion of the elongated body 108 shown in FIG. 3C shows the angled edge of the distal blade 110a and the proximal blade 110b, which facilitate cutting of the target tissue. In alternative embodiments, the blade 110 may have a variety of alternative shapes and configurations. The distal portion of the body 108 has a very low profile (height compared to the width) as shown in the side view of FIG. 3D, in which only the blade 110 is the top surface of the elongated body 109. Protruding from. In one embodiment, as shown in FIG. 3D, a guide wire tube 120 (or lumen) extends from (or is connected to) the lower side of the elongated body 108. The underside of the elongated body 108 is an example of a protective surface or a surface that does not modify tissue.

  In one embodiment, the distal blade 110a is connected using two pull wires 118 as shown in FIGS. 3C, 3E and 3F. A puller wire 118 coupled to the handle 104 and moved by the actuator 106 moves the distal blade 110a proximally and contacts the cutting edge of the proximal blade 110b, thereby cutting tissue. Other alternative mechanisms, such as gears, ribbons or belts, magnets, power, shape memory alloys, electromagnetic solenoids, etc., coupled to a suitable actuator and driving the blade 110 may be used in alternative embodiments. As described above, in one embodiment, the distal blade 110a and / or the proximal blade 110b may have an outwardly curved shape along its cutting edge. Alternatively, the distal blade 110a may comprise a variety of blade shapes including flat, rectangular, V-shaped, and inwardly curved shapes (concave vs. convex). The cutting edge of one blade 110 has a sharp edge formed by a simple bevel or surface. Alternatively or additionally, the cutting edge may have a toothed member that engages the cutting edge of the opposing blade, or has a corrugated ridge, sawtooth, file-like shape, etc. Also good. In various embodiments, both blades 110 may be sharp, or one blade 110 may be sharp and the other may be substantially flat and the sharp blade 110 may have a surface to cut. Alternatively or additionally, both cutting edges are uniform in hardness, or the first cutting edge may be harder than the second cutting edge, the latter being the first hard edge The target tissue is easily cut by the influence of the force from the part.

  3E and 3F are cross-sectional views of the elongate body on lines AA and BB in FIG. 3C. In some embodiments, all or a portion of the elongate body 108, such as the lower side shown in FIG. 3E, is a smooth surface to facilitate operation of the instrument in a surgical space and anatomical location. May be included. The smooth lower surface also provides a barrier between the blade 110 and non-target tissue in the surgical space. The underside may include a guide member lumen 120 to accommodate a guide wire or other access device or rail. FIG. 3E shows the distal blade 110 connected by a pull wire 118. FIG. 3F shows a proximal blade 110 b that is not connected by a pull wire 118 and is secured to the body 108. In various alternative embodiments, the proximal blade 110b is movable in the distal direction, the distal blade 110a is stationary, both blades may move relative to each other, or backstop Various blades may be used, such as one blade pulled towards or two or more blades in which one or more are movable. In various alternative embodiments, the guide member lumen 120 may be provided on the side or center of the elongated body 108. In further alternative embodiments, the one or more guide member lumens 120 may have one or more different cross-sectional shapes, such as substantially circular, generally oval, or generally rectangular, For example, adapt to flat or rectangular guide wires, needles or rails. In yet another alternative embodiment, the guide member lumen 120 may be adjustably coupled by the elongated body 108, allowing manipulation of the position of the tissue modifying member 110 relative to the elongated body 108 and thus the guide member. To.

  Referring now to FIGS. 3G-3I, the blade 110 is shown closed. In one example, when distal blade 110a is pulled proximally to cut tissue, at least a portion of the cut tissue is captured in the hollow inner portion of elongated body 108. Various embodiments may further comprise a cover, a cut tissue housing, and / or the like for collecting cut tissue and / or tissue fragments. Such collected tissue and debris is then removed from the patient during or after the tissue modification procedure. During a procedure that modifies a given tissue, the distal blade 110a, which can be pulled in a distal direction, is pulled proximally to cut tissue and pulled proximally to cut a desired amount of tissue. Cut the tissue further as many times as necessary.

  The blade 110 is made from a suitable metal, polymer, ceramic, or combination thereof. Suitable metals include, for example, stainless steel (303, 304, 316, 316L), nickel titanium alloy, tungsten carbide alloy, or cobalt chromium alloy, such as Elgiloy® (Elgin Special Metals, Elgin, Illinois, USA). ), Conichrome® (Carpenter Technology, Reading, Pennsylvania, USA), or Phynox® (Imphy SA, Paris, France). In some embodiments, the blade, or part of the blade or the coating material, is selected for its electrical conductivity or heat resistance characteristics. Suitable polymers include nylon, polyester, Darcon®, polyethylene, acetal, Delrin® (DuPont, Wilmington, Germany), polycarbonate, nylon, polyetheretherketone (PEEK), polyetherketone Ketone (PEKK) is included, but is not limited to these. In some embodiments, the polymer is filled with glass to increase strength and stiffness. Ceramics include but are not limited to alumina, zirconia, and carbide. In various embodiments, the blade 110 may be manufactured using metal injection molding (MIM), CNC machining, injection molding, and / or grinding. The pull wire 118 may be made of metal or polymer, and may have a circular, oval, rectangular, square, or knitted cross section. In some embodiments, the diameter of the puller wire 118 may range from about 0.001 to 0.050 inches, more preferably from about 0.010 to 0.020 inches.

  Depending on the tissue to be treated or modified, the actuating blade 110 (or other tissue modifying member of an alternative embodiment) modifies the target tissue along regions having various suitable lengths. In use, it is advantageous to limit the operating range of the blade 110 or other tissue modifying member to the desired tissue length so that the blade 110 cannot affect the tissue beyond that length. By limiting the influence of the blade in this way, undesirable modification or damage of the surrounding tissue and structure is limited or prevented. For example, in one embodiment that utilizes tissue modification devices to modify tissue in the spinal column, the blade 110 operates along a target tissue length of 10 cm or less, preferably 6 cm or less, and more preferably 3 cm or less. To do. Of course, other tissue modification devices may be used in other parts of the body that handle other tissues, and the tissue modification members may have different lengths of activity. In one embodiment, a tissue modifying member and / or an elongated body and / or one or more additional features intended for such purpose are intended to facilitate proper placement of a tissue modifying member, such as blade 110, relative to a target tissue. May be made of a material that can be easily identified by X-ray, fluoroscope, magnetic resonance, or ultrasonic diagnostic imaging techniques.

  In various embodiments, various techniques are used to prevent the blade 110 (or other tissue modifying member) from extending significantly beyond the target tissue. For example, in one embodiment where blade 110 extends significantly beyond the target tissue, device 102 is prevented from moving toward the proximal portion or toward the distal portion while actuating blade 110. Therefore, it is necessary to hold the tissue correction device 102 so as to be completely stable. Holding the device 102 stationary is accomplished by securing one end of the device and applying tension to or near the other end, as further described below.

  In the embodiment shown in FIGS. 3A-3I, the puller wire 118 is retracted proximally by grasping the actuator 106 proximally. In an alternative embodiment, grasping the actuating portion 106 causes both blades 110 to move inward and meet approximately at the center of the opening 111. In a further embodiment, the distal blade 110a may be configured with the device 102 by, for example, using a distal actuator attached to the distal wire or by pulling a distal guide member attached to the distal blade 110a. The starting position may be returned by a pulling force generated from the distal end. In yet another example, the proximal blade 110b may be used, for example, by using a distal actuator attached to the distal wire or by pulling a distal guide member attached to the proximal blade 110b. The device 102 may be moved and cut by a pulling force generated from the distal end of the device 102. In yet another embodiment, grasping the actuating portion 106 moves the proximal blade 110b in the distal direction and secures the distal blade 110a. In other alternative embodiments, one or more blades 110 may move from side to side, one or more blades 110 may jump out of opening 111, slide, or move up and down, or one or more The blade 110 may extend through the opening. In another example, one or more blades 110 and / or other tissue modifying members of the device 102 may be a power device configured to cut, sharpen, crush, polish, and / or cut the target tissue. . In other embodiments, one or more blades are coupled to an energy transfer device, such as a radio frequency (RF) or heat resistant device, to cut, remove, shrink, incise, incise, consolidate, or heat the blade. May be supplied with energy to facilitate tissue modification. In another embodiment, a demon file or file may be used with or coupled to one or more blades. In any of these embodiments, the actuator 106 and the one or more moving blades 110 modify tissue by a relatively small overall movement or other action of the tissue modification device 102. Thus, the target tissue may be modified without extending the blade 110 or without significantly exceeding the area of the target tissue where other tissue modifying members are treated.

  4A-4C, in an alternative embodiment, the tissue modification device 202 is coupled to an elongated body 208 having a proximal portion and a distal portion 209, a handle 204, and the proximal portion. It comprises an actuating portion 206, an opening 211, and a tissue modifying member 210 disposed near the distal portion 209. As clearly shown in FIGS. 4B and 4C, in the illustrated embodiment, tissue modifying member 210 comprises an RF electrode wire loop. The wire loop 210 may comprise any suitable RF electrode commonly used and known in the electrosurgical field, such as an internal or external RF generator such as that provided by Gyrus Medical (Maple Grove, Mongolia). Power may be supplied by an RF generator. Various embodiments may use various ranges of radio frequencies. For example, some embodiments may use RF energy in the range of about 70 hertz and about 5 megahertz. In some embodiments, the RF energy power range may be about 0.5 watts to about 200 watts. Further, in various embodiments, RF current may be delivered directly to conductive tissue, or in some embodiments, sarin or lactate that is heated, evaporated, and converted to a plasma that modifies the target tissue. It may be delivered to a conductive medium such as a Ringer solution. The distal portion 209 may have a tapered tip similar to that described above to facilitate the elongate body 208 passing through a portion of a thin body structure. Handle 204 and actuating portion 206 are similar to those described above, but in the embodiment of FIGS. 4A-4C, actuating portion 206 may be used to vary the diameter of wire loop 210. Actuator 206 may be used to extend, expand, retract, and move wire loop 210 from opening 211. Some embodiments may optionally include a second actuator, such as a foot switch, that activates the RF generator to deliver RF current to the electrodes.

  The elongated body 208 may be manufactured from a suitable material and may have a variety of configurations. In one embodiment, the body 208 comprises a metal tube having a full thickness slit (not shown) or a stiffening member (not shown) that unfolds the tube into a flat shape. Slit tubes provide a simple manufacturing process and a conductive path for bipolar RF processing.

  Referring to FIG. 4C, insulator 222 is placed around a portion of wire loop 210 and only the desired portion of wire loop 210 conducts RF current to the tissue to modify the tissue. The wire loop 210 covered by the insulator 222 extends proximally to the support tube 218. In various alternative embodiments, the electrode tissue modifying member (wire loop 210 is an example) may be bipolar or monopolar. For example, as shown in FIG. 4C, the sleeve 224 housed toward the distal portion of the opening 211 functions as a counter electrode plate for the wire loop 210 of the bipolar device. The wire loop electrode 210 may be made from various conductive metals such as stainless steel alloys, nickel titanium alloys, titanium alloys, tungsten alloys and the like. The insulator 222 can be made from a thermally and electrically stable polymer such as polyimide, polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyamideimide, etc., and may be optionally reinforced fiber, Alternatively, a knitted fabric that adds rigidity and strength may be included. In alternative embodiments, the insulator 222 may be composed of a ceramic-based material.

  In one embodiment, the wire loop 210 is housed within the elongate body 208 upon delivery of the tissue modification device 202 into the patient's body and then extends outwardly from the opening 211 relative to the remainder of the body 208. And remove the tissue. The wire loop 210 may be flexible so as to jump out or open up and down from the opening 211 and affect when contacting a hard tissue surface. The wire loop 210 may have various shapes such as curved, flat, spiral, or wavy. The wire loop 210 has a diameter similar to the width of the body 208, and in an alternative embodiment, expands when extending from the opening 211 and has a diameter that is smaller or larger than the diameter of the body 208. It may be. A puller wire (not shown) may be pulled proximally in the same manner as described above, crushing the wire loop 210, reducing the diameter of the wire loop 210 to lower its profile, and / or wire The loop 210 is pulled proximally to remove tissue or housed within the body 208. The low profile of the deflated wire loop 210 facilitates insertion and removal of the tissue modification 202 before and after tissue modification. As the diameter of the wire loop 210 decreases, the support tube 218 deflects toward the center of the elongated body 208.

  In alternative embodiments (not shown), the tissue modification device 202 may comprise a plurality of RF wire loops 210 or other RF members. In another example, the device 202 may include one or more blades and an RF wire loop 210. In such embodiments, the wire loop 210 may be used to remove or modify soft tissue such as the yellow ligament, or to stop hemostasis, and the blade may be used to modify hard tissue such as bone. It may be used. Other embodiments modify various types of tissue using two separate tissue modifications (or two or more devices) in one procedure, as described further below, to modify one type of tissue. You may strengthen it.

  In other alternative embodiments, the tissue modification device 202 includes a long joule, curette, scalpel, scissors, forceps, probe, demon file, file, abrasive member, one or more small surfaces, a rotary power mechanism shaver, Tissue modifying members such as reciprocating power mechanism shavers, power mechanism flashes, lasers, ultrasonic crystals, cryogenic probes, pressurized water jets, dosing members, needles, needle electrodes, or combinations thereof may be provided. In some embodiments, it may be advantageous to have one or more tissue modifying members that stabilize the target tissue, eg, by grasping the tissue or using tissue restraining means such as bolts, hooks, compression members, and the like. In one example, soft tissue may be stabilized by providing a cold containing material that hardens the tissue (e.g., in the cold region), thus, cutting the tissue with a blade, file or other device. make it easier. In another example, one or more hardened materials or members, such as bioabsorbable rods, may be applied to the tissue.

  Referring now to FIGS. 5A-5D, one example of a method for modifying tissue in the spinal column is shown in a simplified schematic cross-sectional view of a patient's back and a portion of the spinal column. FIG. 5A shows a cross-section of a portion of a vertebra, a spinal cord with a branching nerve root, and a portion of a patient's back with a target tissue, in which the target tissue is the ligamentum flavum and possibly small ligaments. It is a facet capsule. The target tissue typically impacts directly with one or more of the groups comprising nerve roots, neurovascular structures, dorsal root ganglia, caudaces, or individual nerves.

  In FIG. 5B, a tissue modification device 102 is placed on the patient's back to perform a tissue modification procedure. Various methods, devices, and systems for introducing the device 102 into the patient's body and advancing the tissue to a position to be modified are further described below. In general, in various embodiments, device 102 is placed percutaneously or initiates a surgical procedure. In one embodiment, the device 102 is inserted into the patient via the first incision 240 and advanced between the target tissue and non-target tissue in the spinal column (such as spinal cord, nerve root, nerve and / or neurovascular). ) Further, the distal portion of the elongated body 108 exits the second (or distal) incision 242 and is located outside the patient's body. In the positioning device 102, one or more tissue modifying members (not shown) are disposed to face the target tissue, and the protective portion of the one or more elongated bodies 108 faces the non-target tissue.

  Referring to FIG. 5C, once the device 102 is in the desired position, a securing force is applied at or near the distal portion of the elongated body 108. In one embodiment, applying the clamping force requires the user 244 to grip the distal portion of the body 108 or near it. In alternative embodiments, as described further below, the securing force may be achieved by placing one or more securing members at or near the distal portion of the body 108, or at least a portion of the body 108. Applied by gripping a guide wire or other guide member extending therethrough. When a fixation force is applied, proximal tension is applied to the device 102, such as by pulling the handle 104 proximally (one-way arrow). When tension is applied to the fixation device 102, the tissue modifying member is moved relative to the target tissue (a unidirectional vertical arrow near the target tissue), thereby facilitating contact with the target tissue and correcting it. Facilitate. With the tissue correcting member in contact with the target tissue, the actuator 106 is gripped or pulled (bidirectional arrow), and the tissue correcting member corrects the tissue. (In alternative embodiments, the alternative actuators operate in different ways)

  In various alternative embodiments, the specific steps described above may be performed in a different order. For example, in one embodiment, the distal portion of the elongate body 108 may be secured within or outside the patient before the tissue modifying member is placed near the target tissue. In another alternative embodiment, the proximal portion of device 102 may be fixed and tension may be applied to the distal portion of device 102. In yet another embodiment, tension may be applied to both ends of the device. In yet another embodiment, the second handle and actuator may be coupled to the distal end of the body 108 after exiting the patient's back to provide tension and tissue modification operations to the proximal portion of the device 102 and It may occur at both the distal parts. By securing one end of the device 102 and applying tension to the other end, contact between the tissue modifying member and the target tissue is enhanced, thereby reducing the need to move or move the entire device 102. Or, remove and reduce the overall profile and generated access paths required to place the device. By reducing the motion and profile of the device 102 and using a tissue modifying member limited to a relatively small area of the device 102, it facilitates modification of the target tissue and minimizes damage to surrounding tissue or structure, Or remove.

  As described above, the tissue may be modified using a tissue modification device or devices according to various embodiments. In one embodiment, for example, an RF electrosurgical tissue repair device may be used in a patient's body to remove soft tissue such as ligaments and added using a bladed tissue repair device such as a Ronjoule. Soft tissue, calcified soft tissue, or hard tissue such as bone may be removed. In some embodiments, such multiple devices are introduced, used, and removed in sequence, while in alternative embodiments, such devices are simultaneously inserted into the patient's body and used in combination.

  Referring to FIG. 5D, a desired amount of target tissue is removed from one or more regions of the spinal column using one or more tissue modification devices 102. 5A-5C illustrate removal of target tissue on one side of the spinal column, and using this and similar methods, the target on the opposite side of the spine as shown in FIG. 5D with the target tissue removed from both sides Remove tissue. The desired amount of removed tissue is obtained by examining nerve conduction using one or more pre-impacted nerves, and examining blood flow using one or more pre-impacted blood vessels. Using the above radiographic examination, or a combination thereof, by passing the measuring probe or sound through the part to be treated (individually or via a guide member) or by any other suitable means , Confirmed by haptic feedback from one device or individual device.

  Referring now to FIG. 6A, a tissue modification device 102 is shown having an embodiment of a distal fixation member 250 disposed on a patient's skin. In various embodiments, the fixation member may comprise one or more handles, rods, hooks, screws, toggle bolts, needles, inflatable balloons, meshes, stents, wires, lassos, backstops, etc. Good, but not limited to these. In some embodiments, the fixation member 250 is disposed at the distal distal portion 109 of the elongate body 108, while in other embodiments, the fixation member 250 is disposed closer. In the illustrated embodiment, a fixation member 250 is placed on the patient's skin. In an alternative embodiment, one or more fixation members 250 may be placed on the skin and fixed outside the patient's body by the user grasping the fixation member 250. In an alternative embodiment, after the tissue modification device 102 is secured to the guide member, one or more securing members 250 are placed on the skin and secured by the user outside the patient's body by grasping the securing member 250. May be. In another alternative embodiment, the fixation member 250 may be secured outside the patient's body by being secured to an external device, such as a device attached to the patient or operating table. In a further alternative, after the tissue modification device 102 is secured to the guide member, the guide member may be secured outside the patient's body by attaching it to an external device, such as a device attached to the patient or operating table. The fixation member 250 can typically be deployed from a first contracted configuration that facilitates delivery of the device 102 to a second expanded configuration that facilitates fixation. This configuration change may be performed, for example, by applying a force to the main body 108 with the fixing member 250 using a spring by using a shape memory or a super elastic material. In many embodiments, the fixation member 250 is collapsed into the first contracted configuration after the tissue modification procedure has been performed to facilitate withdrawal of the device 102 from the patient. In an alternative embodiment, the fixation member 250 may be removed from the body 108 and can be easily removed from the patient's skin.

  FIG. 6B shows the tissue modification device 102 having an alternative embodiment of the distal fixation member 260. Here, the distal fixation member 260 comprises a plurality of hooks or bars extending from the distal portion 109 of the elongated body 108 on the patient's back. Using such an embodiment does not require the guide member 117 to pass through the patient's second distal incision, but in some embodiments, the guide member 117 extends beyond the distal portion 109. It may extend significantly. The fixation members 260 according to various embodiments may be positioned for fixation to bone, ligaments, tendons, capsules, cartilage, muscle, or other suitable patient tissue. They may be placed in the vertebrae or other suitable tissue in the immediate vicinity of the intervertebral foramen or further away from the intervertebral foramen. When the tissue modification procedure is complete, the fixation member 260 is retracted into the elongated body for removal of the device 102 from the patient.

  Referring now to FIGS. 7A through 70, a system and method for introducing a tissue modification device into the spinal column is shown. This system and method is referred to as an “access system” or “access method” and provides or facilitates access to the target organization being modified. Of course, the illustrated embodiment is merely an illustrative embodiment, and one or more devices may be introduced using many other suitable methods, devices or systems to modify tissue within the spinal column. For example, in an alternative embodiment, the spinal tissue correction procedure is performed by surgical opening means. Accordingly, the following description is primarily for purposes of illustration and should not be construed as limiting the scope of the invention as defined in the claims.

  Referring to FIG. 7A, in one embodiment, a method for delivering a device initially includes a plunger 310, a barrel 308, and a fluid and / or air 306 coupled to a proximal portion of a needle 300 (or cannula). Need to be advanced to the patient's back. The distal portion of the cannula 300 is advanced through the ligamentum flavum until it enters the central spinal canal, causing a loss of pressure on the plunger 310, and fluid and / or air 306 is injected into the central spinal canal, as shown in FIG. 7B. Check for correct placement of cannula 700. Next, as shown in 7C, the syringe 304 is removed and a guide wire 312 having a non-rigid, non-traumatic tip is advanced through the cannula 300 and into the central spinal canal as shown in FIG. 7D. Next, as shown in FIG. 7E, the cannula 300 is removed and the guidewire 312 remains. As shown in FIGS. 7F and 7G, the introducer sheath 114 coupled to the dilator 314 is advanced along the guidewire 312 and the distal portion of the sheath 114 is placed at the desired location within the spinal column. Next, as shown in FIG. 7H, the dilator 314 and the guide wire 312 are removed.

  Once the introducer sheath 114 is deployed, one or more curved or movable guide devices 318 pass through the introducer sheath to a desired location in the spinal column and / or within the spinal column, as shown in FIGS. 7I and 7J. Advance to the desired position through. Next, the one or more guide members 116 are advanced through the guide device 318 as shown in FIGS. 7J to 7L. Finally, as shown in FIG. 7M, the guide device 318 is removed, and as shown in FIG. 7N, the elongated body 108 of the tissue modification device 102 passes along the guide member 116, through the introducer sheath 114, and the spinal column. Advance to the desired position. As shown in FIG. 7O, the elongated body 108 is tensioned, while the tissue modifying member 110 moves relative to the target tissue, as indicated by the arrow at the opposite end of the device 102, while the distal portion 109 Is fixed by hand in this case. In an alternative embodiment, guide member 116 is tensioned to move tissue modifying member 110 relative to the target tissue as shown in FIG. 7N.

  When the tissue modification device 102 is placed in the desired location, the tissue modified in various embodiments includes ligaments, tendons, tumors, cysts, cartilage, scars, “osteophytes”, and inflammatory bone tissue. Including, but not limited to. In some embodiments, modifying the target tissue reduces tissue collisions of the spinal cord, bifurcating nerves or nerve roots, dorsal root ganglia, and / or vascular tissue within the spinal column. Actuator 106 on handle 104 operates to modify the target tissue using tissue modifying member 110, while elongated body 108 is relatively stably secured by the tension applied to hand 244 and handle 104. .

  In various embodiments, the systems and methods described above may include additional features or steps, may include some features or steps, may differ in order of execution of steps, or may have different features. Or it may comprise a step. For example, in some embodiments, the placement of the device 102 is performed in a medical-to-lateral direction (relative to the patient), while in alternative embodiments, the placement of the device is: It is done in the lateral-to-medical direction. In some embodiments, one or more components of the described system, such as guide member 116 or introducer sheath 114, are secured to the patient. In various embodiments, the one or more guide members 116 may include one or more wires, rails, or tracks, and may include a guide device 318, an introducer sheath 114 that does not include the guide device 318, a cannula 300, Insertion may be performed using an epidural needle, an endoscope lumen, a tissue protection or barrier device, a curved guide device 318 disposed through the endoscope lumen, or the like. In other embodiments, for example, guide device 318 may be placed through introducer cannula 300 and introducer sheath 114 may pass along device 318. Similarly, tissue modification device 102 may be inserted with or without these devices or components of various embodiments. The various guidewires 312, guide devices 318 and / or guide members 116 may be pre-shaped to have one or more curves, may be movable, and / or one or more rails, tracks. , Grooves, lumens, slots, partial lumens, or combinations thereof.

  In some embodiments, the tissue modification device 102 is inserted through one or more of the hollow devices described above (the introducer sheath 114 shown or the alternative embodiment cannula 300), and in such a method, the device 102 expands by extending from the distal portion of the hollow delivery device, and is thus considered a wide profile that modifies so many target tissues in a single location. In an alternative embodiment, the device 102 retains the same overall profile when inserted and used. In some embodiments, one or more delivery devices remain in the patient during use of the tissue modification device 102, while in alternative embodiments, all delivery is performed when the tissue modification device 102 is operating. The device is removed from the patient. In some embodiments, the tissue modification device 102 is slidably coupled to one or more delivery devices during delivery and / or use. In one embodiment, the tissue modification device 102 is advanced through the introducer sheath 114, which is used as an irrigation and aspiration lumen to clean the area of the target tissue and usually remove the removed tissue, other debris. Aspirate with a vacuum. In an alternative embodiment, the tissue modification device 102 includes a cleaning and / or suction lumen to clean a region of tissue and suction removed tissue and other debris.

  Some embodiments of an access system that facilitates tissue modification may further comprise one or more visualization devices (not shown). Such a device is used to facilitate the placement of an access system that introduces a tissue modification device, facilitates tissue modification itself, and facilitates a combination of these functions. Examples of visualization devices used are flexible, partially flexible, or rigid fiber optic scopes, rigid rod and lens endscopes, rigid or flexible probe remotes. A CCD or CMOS chip at the center, LED illumination, or a fiber or transmission of an external light source for illumination may be included. Such a device may be slidably coupled to one or more components of the access system, or may be slidably coupled or secured to a tissue modification device. In other embodiments, additional or alternative devices may be incorporated to help place, use or evaluate the effects of the tissue modification device. Examples of such other devices include EMG or SSEP monitors, ultrasound imaging transducers external or internal to the patient, computed tomography (CT) scanners, magnetic resonance tomography (MRI) scanners, reflection spectrophotometric devices, and One or more neural stimulation electrodes may be provided having a tissue electrical resistance monitor disposed on the global electrode tissue modification member or disposed at any location on the tissue modification device or disposed on the access system.

  Referring now to FIGS. 8A-8E, in an alternative embodiment, the tissue modification device and any one or more introducer / access devices are placed in the patient's body using open surgical techniques. As shown in FIG. 8A, for example, in one embodiment, a laparotomy incision is made in the patient's back and two retractors 402 are used to expose a portion of the patient's vertebrae. Next, as shown in FIG. 8B, an introducer sheath 414 is inserted between the retractors 402 through the incision. Next, as shown in FIG. 8C, the curved guide device 418 is inserted through the introducer sheath 414. Guide device 418 extends into the epidural space as shown in FIG. 8D and passes between the ligamentum flavum.

  In some embodiments, a thin sharp probe into which a curved cannula is inserted is placed in the epidural space of the spinal column through an open incision, and alternatively placed through an introducer sheath 414. Also good. The tip of the probe is advanced into or through the nerve hole. Such a probe is similar in shape to, for example, a Woodson elevator, a Penfield 3, a hockey stick probe, a probe with a ball attached to the tip, and the like. Alternative embodiments use a probe that is manually bent to change shape, a probe with an articulating tip, a probe with a shape anchor, and / or a probe with a groove instead of a cannula. May be.

  As shown in FIGS. 8D and 8E, a substantially straight flexible guidewire 420 having a sharp tip 422 is inserted and advanced through a curved guide device 418 and its distal end having a sharp tip 422. The position exits from the patient's back at a position different from the open incision (FIG. 8E). Next, the guide device 418 is removed as shown in FIG. 8F, and in subsequent steps, the tissue modification device is introduced along the guide wire 420 into the introducer sheath 414, as described in more detail below. Used to correct In an alternative embodiment, a curved flexible cannula is inserted into the curved guide device until it extends beside the nerve hole, after which it is substantially straight and flexible with a sharp tip. A guide wire is inserted into the curved cannula and advanced, with the distal portion having a sharp tip extending outward from the patient's back.

  Referring now to FIGS. 9A and 9B, another alternative open access method is shown. In FIG. 9A, a curved guide device 446 disposed through the epidural space and intervertebral foramen is shown, and a guide wire 440 having a sloped distal tip 442 is routed through the guide device 446. Advance. As shown in FIG. 9B, in this embodiment, guidewire 440 is guided by guide device 446 through an open incision through which various access devices are introduced. Thus, in such an embodiment, only one incision is formed and the proximal and distal portions of one or more devices exit from the patient's back through the same incision.

  In various alternative embodiments, laparotomy access passes through the exposed portion to the lamina, through the yellow ligament where the lamina has not been removed, and through the yellow ligament where the lamina has been partially or completely removed. Through the yellow ligament with or without the plate layer with partial or complete removal of the intermediate facet joint, through the open exposed area, laterally through the skin, and open through the open exposed area Return to the exposed area or pass through the laterally open exposed area to access the nerve hole from the side. One or more visualization devices are used in open access procedures and percutaneous or atraumatic procedures. In another alternative embodiment (not shown), the tissue modification device may be placed directly on the patient without the introduction device.

  Referring now to FIGS. 10A through 10E, in the embodiments described above, the tissue modification devices 102, 202 have at least one non-tissue modification (or “protect”) portion, side, or surface. The non-tissue modifying portion is disposed on the tissue modifying devices 101, 202 such that the tissue modifying members 110, 210 are disposed near the non-target tissue when facing the target tissue. The non-tissue modifying surface of the device is configured to not modify or damage the tissue, thereby protecting the non-target tissue from undesirable modification or damage during the tissue modifying procedure.

  Optionally, in some embodiments, the tissue modification device or system further comprises one or more tissue protectors or barriers that further protect the non-target tissue. Such a protector is slidably connected to the tissue modifying device, secured thereto, or pulled away from the device using the protector. In various embodiments, the protector is delivered between the target tissue and the non-target tissue before delivering the tissue modifying device, delivered with the tissue modifying device, or after delivery of the tissue modifying device and the device is Delivered before operation. Generally, the protection unit is disposed between the non-target tissue and the tissue correction device.

  FIG. 10A shows the distal portion of the introducer 514 through which the protective portion is introduced. FIGS. 10B and 10C show an embodiment of a partially deployed protection device 500 and a cross section thereof, respectively. Typically, the protector 500 includes a first small profile configuration for delivery to an area near the non-target tissue and an expanded configuration for protecting the non-target tissue. The protector itself may be a superelastic or shape memory material, as a skeleton with a material covering between skeletons, as a series of expandable wires or tubes, as a semi-circular stent-like device, as one or more It may be configured as an inflatable balloon or bag, as a fan or spring loaded device, or as various devices configured to expand and protect tissue when released from the delivery device. As shown in FIGS. 10B and 10C, the protector 500 may comprise a sheet material that is disposed at the first end 502a adjacent to the second end 502b in the introducer 514 and that expands upon delivery. In an alternative embodiment, the single ends 522a and 522b of the protective device 520 overlap within the introducer 514, as shown in FIGS. 10D and 10E. In general, in one embodiment, the protectors 500, 520 are introduced via an introduction device 514, and alternatively, a tissue such as the tissue modification device described in connection with FIGS. 7A-7S, 8A-8F, 9A and 9B. In order to introduce the correction device, it may be introduced using various means. In some embodiments, the protectors 500, 520 may be secured to the tissue modification device or to an extension thereof. The protectors 500, 520 may also be used to pass visualization devices to introduce, remove or replace various tissue modification, drug delivery, or diagnostic devices for passing a guide wire or other guide member. In addition, one or more lumens, rails, passages, and the like may be provided to wash the fluid at the tissue modification site. In some embodiments, the protectors 500, 520 are advanced along a plurality of guidewires that remain in place during the tissue modification procedure to stabilize the protectors 300, 320 and Promote maintaining position.

  Referring now to FIGS. 11A and 11B, in an alternative embodiment, the powered tissue modification device 200 is preferably an elongated shaft 2001 having a proximal portion 2002, a distal portion 2003 and a longitudinal axis 2008. And one or more tissue modifying members 2004 coupled to or near the distal portion 2003 of the shaft 2001 and a handle 2006 coupled to or near the proximal portion 2002 of the shaft 2001. Optionally, some embodiments may include one or more power connectors that connect device 2000 to one or more power sources. In some embodiments, the shaft 2001 allows at least the distal portion 2003 to pass between a target tissue such as the ligamentum flavum and a non-target tissue such as nerve and neurovascular tissue within the epidural space of the spinal column. Has a size and shape to facilitate. In some embodiments, the shout 2001 may include one or more bends and curves at or near the distal portion 2003 to further facilitate passage and placement of the device 2000. In some embodiments, at least a portion of the distal portion 2003 may be facilitated at least partially through the intervertebral foramen, for example, by a bend or bend.

  In some embodiments, as shown in FIG. 11A, the distal portion 2003 of the device 2000 is advanced through the skin on the patient's back near the spinous process. Next, the distal portion 2003 is advanced into the epidural space between adjacent vertebral body lamellas and advanced between the target and non-target tissues to modify the target tissue 2004 to modify the target tissue. Is placed in a desired position. Next, power is supplied to actuate the tissue modification member 2004, thereby modifying the target tissue. The portion of the device 2000 near the tissue modifying member 2004 is configured to face the non-target tissue and the tissue modifying member 2004 to face the target tissue, thereby causing undesirable damage or non-target tissue damage. Prevent modification. In some embodiments, as described above, the portion of the device that faces the non-target tissue protects the tissue with the delivered material and / or examines the non-target tissue and is non-target tissue The non-target organization is configured to be corrected by a method such as confirmation.

  In various embodiments, the handle 2006 has a suitable configuration and characteristics. In some embodiments, the handle 2006 includes one or more actuators that actuate the tissue modification member 2004. The power connector 2010 can have any suitable configuration, and can transmit a suitable type of energy, such as electricity, radio frequency, ultrasound, laser, or conduction energy, from various external power sources (not shown) in various embodiments. Send to device 2000. In alternative embodiments, the device 2000 is battery operated or uses other suitable internal power or power sources, such internal energy sources housed within the handle 2006, for example. The Typically, power is sent from the source to the tissue modification member 2004, which is actuated to modify the tissue.

  Referring now to FIG. 11B, in various embodiments, the tissue modification device 2000 is advanced into the patient's body using various suitable techniques and means, some of which have already been described. FIG. 11A shows one means for advancing the distal portion 2003 of the device 2000 from the opposite means to a position between the target tissue and the non-target tissue, and FIG. 11B shows the means on the same side. Yes. As shown in FIG. 11B, the distal portion 2003 has two or more curved portions and / or is at least partially flexible or movable to facilitate a desired approach angle according to various embodiments. Have sex.

  Referring to FIG. 12, in another embodiment, a tissue modification device 2020 is coupled to an elongate shaft 2011 having a proximal portion 2012 and a distal portion 2013, one or more tissue modification members 2014, and the shaft 2011. A conductive electrode 2015, a handle 2016, a power connector 2030, and a plurality of additional connecting members 2032 and 2033 are provided. Electrode 2015 is configured to send non-target frequencies and non-target current amplitudes to non-target tissue. Non-target frequencies and non-target amplitudes stimulate responses from neural tissue. In one example, the first connecting member 2032 provides power to the electrode 2015, and this stimulation as seen by observing EMG, SSEP or muscle movement when non-target tissue is stimulated by current from the electrode. Illuminates that the electrode 2015 is near the non-target tissue. Further, the current that stimulates the target is supplied to the tissue correction member 2014 (for example, made of an electrically conductive material) via the second connection member 2033 and / or the same side as the tissue correction member 2014. To a target stimulation electrode located near and on the device 2020. For example, if the current that stimulates the target is configured with a frequency and amplitude that stimulates a response from neural tissue, the tissue type immediately adjacent to the tissue modification member 2014 (eg, nerve or not nerve) Judgment based on the presence or absence of reaction. In one embodiment, device 2020 is configured to allow control of currents that stimulate targets and currents that stimulate non-targets. For example, currents that stimulate the target and currents that stimulate the non-target are sequentially sent to the distal portion 2013 of the device 2020 to determine the position of the neural tissue before the tissue correction member is activated, for example, the tissue correction member 2014. Ensure that the nerve tissue is not damaged.

  In various embodiments, the tissue modification member 2014 includes one or more long joules, curettes, scalpels, one or more cutting blades, scissors, forceps, probes, demon files, files, abrasive members, one or more small surfaces, Electrosurgical device, bipolar electrode, monopolar electrode, thermal electrode, rotary power mechanism shaver, reciprocating power mechanism shaver, power mechanism flash, laser, ultrasonic crystal, cryogenic probe, pressurized water jet, dosing member, It may comprise at least one of a needle, a needle electrode, or a combination thereof. Some embodiments include one tissue modification member 2014, and other embodiments include a plurality of tissue modification members 2014. As described further below, the tissue modification member 2014 has a variety of suitable sizes, shapes and configurations and may move or operate in any suitable manner.

  Referring now to FIG. 13A, in an alternative embodiment, a tissue modification device 2040 includes an elongate shaft 2041, one or more tissue modification members 2044, a handle 2046, and a power connector 2050. In addition, the device 2040 includes a guidewire lumen (not shown) extending through all or part of the shaft 2041, through which a guidewire 2048 having a proximal end 2049 and a distal end 2047 passes. Enable. In one example, for example, guidewire 2048 extends from the proximal end of shaft 2041 through the distal end of shaft 2041 and out of the patient's body. In some embodiments, as described above, fixation force and / or tension is applied to or near the distal end 2047 and / or proximal end 2049 to move the tissue modification member 2044 relative to the target tissue. You may let them.

  In the embodiment shown in FIG. 13A, a tissue modifying member 2044 having a relatively flat configuration is shown. In many of the secondary embodiments described herein, various embodiments of tissue modifying members are shown having a flat configuration, primarily for ease of explanation. However, in an alternative embodiment, and with reference to FIG. 13B, the tissue modification device includes a curved and / or flexible tissue modification member having a curved / flexible surface that contacts the target tissue. 2045 (or a plurality of curved and / or flexible members). The device 2040 may also include a curved and / or flexible shaft 2042. In some embodiments, such a curved and / or flexible tissue modifying member 2045 (or tissue modifying surface) and shaft 2042 facilitate tissue modification, and the tissue modifying member 2045 can be Make verification even easier. In alternative embodiments, many but not all of the devices described in this application may have such curved and / or flexible tissue modifying members.

  Referring now to FIGS. 13C through 13E, several alternative embodiments of a fixation member for use with a tissue modification device are shown. FIG. 13C shows a tissue modification device 2040 comprising, for example, a wire anchor 2060 coupled to a guidewire 2048. FIG. In various embodiments, the wire anchor 2060 is removably attached or secured to or near the distal end 2047 of the guidewire 2048 to provide a securing force against the patient's back from outside the patient's body. Wire anchor 2060 minimizes or prevents guide wire 2048 from moving from the patient's back toward proximal end 2049. In an alternative embodiment, additional securing force and / or tension is supplied to the distal end 2047 by grasping and / or pulling the distal end 2047 by hand.

  In an alternative embodiment, as shown in FIG. 13D, the distal end 2047 of the guidewire 2048 has one or more deployable fixation members 2062, which are deployed in the patient's body and are muscular. Fix the patient's back tissue, such as bones, ligaments. In one example, for example, the guidewire 2048 may include one or more lumens (not shown), and the fixation member 2062 moves within the lumen and extends from the distal end 2047. When the tissue modification procedure is complete, the fixation member 2062 retracts into the lumen and the guidewire 2048 is more easily removed from the patient.

  Referring to FIG. 13E, in another embodiment, the tissue removal device 2040 includes one or more proximal shaft fixation members 2066 and / or one or more proximal guidewire fixation members 2064. In an alternative embodiment, the shaft securing member 2066 may be coupled to or removably coupled to the shaft 2041 to facilitate applying a securing force. For example, in one embodiment, shaft fixation member 2066 contacts the patient's back and prevents shaft 2041 from moving into the patient's body.

  Proximal guidewire securing member 2064 may be provided in handle 2046 as shown, and in other embodiments may be located near or far from handle 2046. A guide wire securing member 2064 is used to lock or secure the guide wire 2048 to prevent or minimize the guide wire from moving in or out of the device 2040. This facilitates the application of tension and / or fixing force via the guidewire 2048.

  13F and 13G show cross-sectional views of the handle 2046 and proximal guidewire anchoring member 2064 of line CC in FIG. In one example, the handle 2046 includes a plurality of proximal guidewire securing members 2064, a tissue modification drive 2068 in the first lumen, a guidewire 2048 in the guidewire lumen 2070, and a corresponding guide tab 2075. Guide slot 2074 and one or more lobes. As shown in FIG. 13F, when the guide wire fixing member 2064 is not engaged, the lobe 2072 does not interfere, so the guide wire 2048 moves freely in the guide wire lumen 2070. As shown in FIG. 13G, when the guidewire securing member 2064 is engaged, for example, by moving and / or rotating the guidewire securing member 2064 relative to the handle 2046, the guidewire 2048 is in the lobe 2072. Between the guide wire fixing member 2064 and the wall of the guide wire lumen 2070 by friction (for example, tightening and pinching). Next, the guide wire fixing member 2064 moves and / or rotates to the original position (FIG. 13F), and the guide wire 2048 is released.

  Referring now to FIG. 14, in some embodiments, a tissue removal device 2100 includes an elongate shaft 2104 comprising a proximal portion 2106 and a distal portion 2105, one or more tissue modifying members 2108, a proximal portion A movable handle 2103 connected to the portion 2106 and a power connector 2107 are provided. In the illustrated embodiment, the distal portion 2105 is at least partially steerable (shown as two overlapping distal portions in FIG. 14) and uses a movable handle 2103 (a straight arrow in both directions). ), Steer the distal portion 2105 and hold the shaft 2104 relatively stable. The steerable distal portion 2105 enhances the ability of the tissue modification member 2108 to contact and apply force to the target tissue. In some embodiments, the placement of the tissue modifying member 2108 is adjusted using the steerable distal portion 2105 without significantly moving the shaft 2104. In some embodiments, the steerable distal portion 2105 may move in a plurality of directions, such as laterally relative to the shaft 2104, up and down. In one embodiment, the movable handle 2103 operates by piston motion, with the distal portion of the handle 2102 attached to the shaft and the proximal handle 2103 attached to the tension member. The tension member transmits tension to the steerable distal end 2105 and deflects the distal end 2105 when the handle 2103 is actuated. In various embodiments, other handle steering mechanisms and / or other steering mechanisms known in the art may be used.

  FIGS. 15A and 15B show one embodiment of a tissue modification device 2080 that includes an elongated shaft 2081, one or more tissue modification members 2082, a handle 2084, a visualization device 2086, and an optical cable 2090. And a power connector 2088. The visualization device 2086 may comprise any suitable device such as, but not limited to, an endoscope. The endoscope visualization device may comprise a lens and / or optical fiber, for example, to deliver light (or other energy) to illuminate the tissue and acquire an image. As shown in FIG. 15B, in some embodiments, the visualization device 2086 includes one or more image acquisition members 2094 and one or more illumination members 2092. In some embodiments, the image acquisition member 2094 comprises a CCD or CMOS chip, for example. The irradiation member 2092 includes, for example, one or more light emitting diodes (LEDs) or optical fibers.

  In some embodiments, the optical cable 2090 comprises an optical fiber. Part or all of the optical fiber includes or is connected to the illumination member 2092. Alternatively or additionally, some or all of the optical fiber may be connected to a camera (not shown). For example, such a camera is attached to the proximal end of the tissue modification device 2080. Alternatively, the optical cable 2090 may comprise a power source (eg, an output LED) and / or one or more electrical wires connected to the image acquisition member 2094. In various embodiments, a lens, fiber optic, LED, or combination thereof may be utilized for illumination along with a lens, fiber optic, CCD, CMOS, or combination thereof used to acquire an image. Also good.

  Referring now to FIG. 16, another embodiment of the tissue modification device 2120 is preferably an elongated shaft 2132, one or more tissue modification members 2130, a handle 2124, a visualization device 2122, an optical cable 2128, And a power connector 2126. In this example, the visualization device 2122 is positioned near the tissue modifying member 2130 on the shaft 2132. In various embodiments, the visualization device 2112 may be positioned along the shaft 2132 at a desired location.

  17A through 17E show cross-sectional views of various embodiments of the shaft 2132 taken along line AA in FIG. In the embodiment shown in FIG. 17A, for example, the shaft 2132 includes a tissue modification drive 2134 in the tissue modification drive lumen 2140 and a guidewire 2136 in the guidewire lumen 2138. The tissue modification drive 2134 may be configured to move or rotate relative to the tissue modification drive lumen 2140. Examples of tissue modification drive 2134 include, but are not limited to, a drive shaft, one or more conductive wires, one or more optical fibers, and the like. Various embodiments also include a motor disposed in the handle of the device, near the distal end of the device, such as in a separate drive device.

  In an alternative embodiment, as shown in FIG. 17B, shaft 2132 includes tissue modification drive 2134 in tissue modification drive lumen 2140, guide wire 2136 in guidewire lumen 2138, and conductive member in visualization lumen 2144. 2146 and a suction / cleaning lumen 2142. The aspiration / wash lumen 2142 delivers, for example, a gas, fluid or pushable solid (eg, a particulate solid) from outside the patient's body to the distal end of the device, or from the target tissue region outside the patient's body, Used to aspirate fluid, tissue and / or other substances. In some embodiments, the suction / wash lumen 2142 is used to slidably pass instruments such as long and flexible needles or biopsy forceps. In some embodiments, the visualization lumen 2144 is configured to receive a conducting member 2146, such as a member that provides power to the LED at the distal end of the device, and / or obtains a visual image, May be configured to send a signal from a CCD or CMOS chip located at the distal end of the device that converts the signal to an electrical signal to a display set outside the patient's body.

  In yet another alternative embodiment, as shown in FIG. 17C, shaft 2132 includes tissue modification drive 2134 in tissue modification drive lumen 2140, conductive member and / or optical fiber 2152 in visualization lumen 2144, A separate suction lumen 2150 and a cleaning lumen 2148 are provided. In some embodiments, the suction lumen 2150 and the irrigation lumen 2148 are used to deliver gas, fluid, and / or pushable solids to and from the distal end of the tissue modification device and simultaneously or sequentially. Remove. The separated and / or unseparated target tissue and other debris of the treatment site are cleaned by delivery and removal of gas, fluid, and / or pushable solids, and / or the target and Maintain a clear visualization of non-target tissues.

  In another embodiment, as shown in FIG. 17D, the optical fiber 2152 is disposed between the various lumens 2148, 2150, 2144, 2140 within the hollow shaft 2132. Alternatively, in other embodiments, the optical fiber 2152 may be replaced with an electrical conductor. The optical fiber 2152 sends light to illuminate the target tissue and / or sends light from the tissue to the display device. In such an embodiment, the visualization lumen 2144 sends light or electrical signals in the proximal method and / or distal direction.

  In yet another alternative embodiment, as shown in FIG. 17E, a shout 2132 includes a steering actuator 2154 within the steering lumen 2156. Steering actuator 2154 is used to steer the distal portion of the tissue modification device, for example, as further described below.

  18 is a cross-sectional view of the end of the tissue modification device 2120 of FIG. 16 taken along line BB. In this example, the visualization device 2122 and the illumination member 2158 are positioned proximate to the tissue modification member 2130. In the illustrated embodiment, the tissue modifying member 2130 comprises a rotating disk provided on the post of the bearing 2160 and a plurality of raised cutting edges 2131 on the disk. Two suction / cleaning lumens 2142 allow for the introduction and suction of gases, fluids, and / or pushable solids from the tissue modification region.

  Figures 19A through 23B show many examples of the distal end of a tissue modification device having various tissue modification members. In these examples, the device can be connected distally by a guidewire or extends distally from the tissue modification portion shown, and the device extends distally from the patient. Referring to FIGS. 19A-19C, in another embodiment, a tissue modification device 2310 is coupled to a drive shaft 2314 extending from a distal opening 2316 and includes a tissue modification member 2312 comprising a movable platform having an abrasive surface. It has. As shown in the various figures, in some embodiments, the tissue modifying member 2312 moves laterally (FIG. 19A), moves back and forth (FIG. 19B), and / or vibrates (FIG. 19C).

  In yet another embodiment, as shown in FIG. 20, a tissue modification device 2320 is coupled to a drive shaft 2324 extending from a distal opening 2326 and comprises a tissue modification comprising an oval or circular platform having an abrasive surface. A member 2322 is provided. In such embodiments, the tissue modifying member 2322 rotates or moves in a circular fashion, and moves, moves laterally, reciprocates, and / or vibrates according to various embodiments.

  Referring to FIG. 21, in another embodiment, tissue modification device 2330 includes a plurality of tissue modification members 2332, each including a movable platform 2333 having an abrasive surface attached to drive shaft 2334. Yes. The tissue modifying members move back and forth relative to each other and the device shaft in a suitable pattern. The ability of tissue modifying members 2332 to move back and forth relative to each other facilitates tensioning the target tissue so that tissue modifying member 2332 can cut, shear, tear and / or modify the target tissue. To strengthen.

  As shown in FIG. 22, in another alternative embodiment, the tissue modification device 2340 preferably includes one or more blades, such as a distal blade 2344a and a proximal blade 2344b, each having a cutting edge 2345a, 2345b. Having a tissue modifying member. In the illustrated embodiment, the proximal blade 2344b is movable and moves distally toward the opposing distal blade 2344a. In alternative embodiments, the distal blade 2344a may be movable, or both blades 2344a, 2344b may be movable. Alternative embodiments include one movable blade, two or more movable blades that contact in one direction, two or more blades that contact in various directions, a movable blade, and a backstop against which the blade abuts, Alternatively, other suitable combinations of movable and / or fixed blades may be provided. Further, the blades of certain embodiments may have any suitable shape, size, and overall configuration. In some embodiments, the blade may be flat, and in other embodiments may be curved, square, wavy, bent, serrated, etc. The blades may be long or short, and the multiple blades may be placed adjacent to each other, like a normal multiple blade razor used to shave a razor. They may be separated from each other by millimeters or several centimeters. The blade may have a suitable degree of sharpness or insensitivity, and in some embodiments, a combination of sharp and insensitive blades may be used. Thus, although exemplary embodiments of blades are described above or described below, other suitable blades or combinations of blades may be substituted in various embodiments without departing from the scope of the present invention. The

  The blades 2344a, 2344b or other blades shown here in alternative embodiments may be made from metal, polymer, ceramic, other suitable materials, or combinations of materials. In various embodiments, suitable materials for the blade include stainless steel (303, 304, 316, 316L), nickel titanium alloy, or cobalt chromium alloy, such as Elgiloy® (Elgin Specially, Elgin, Illinois, USA). Metals), Conichrome® (Carpenter Technology, Leading Pennsylvania, USA), or Phynox® (Imphy SA, Paris, France), but are not limited to these. Polymers include nylon, polyester, Darcon®, polyethylene, acetal, Delrin® (DuPont), polycarbonate, nylon, polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). . In some examples where polymers are used, such polymers may be glass filled or carbon filled to increase strength and rigidity. Ceramics include but are not limited to alumina, zirconia, and carbide. The blade may be manufactured using techniques well known in the art, such as metal injection molding (MIM), CNC machining, injection molding, polishing, EDM, metal plate bending, etching, and the like. Other portions of the tissue modification device, such as one or more blade-like covers and other features, may be made of suitable materials known or discovered herein. For example, blade covers are made of nylon, silicone, ether ether ketone (PEEK), and polyether ketone ketone (PEKK), polytetrafluoroethylene (PTFE), polyurethane (Tecothane), Pebax (US company), polycarbonate, Derlin ( US companies), high density polyethylene (HDPE), low density polyethylene (LDPE), HMWPE, UHMWPE, etc. may be made of various embodiments of one or more polymer materials.

  Referring now to FIG. 23A, in one embodiment, the tissue modification device 2350 is preferably a substantially cylindrical, circular or curved shaft 2352 and one or more substantially cylindrical, circular or curved shafts. Blade 2354. In the illustrated embodiment, the blade 2354 protrudes from the opening 2358 of the shaft 2352. As the blade 2354 moves in the proximal direction (arrow), its cutting edge 2356 may move toward and engage the opposing cutting edge 2356 of the shaft 2352.

  In another example, as shown in FIG. 23B, the tissue modification device 2360 preferably includes a substantially cylindrical, circular or curved shaft 2362 and one or more substantially cylindrical, circular or curved shafts. Blade 2364. In the illustrated embodiment, blade 2364 projects from opening 2368 in shaft 2362. Blade 2364 rotates (arrow) and its cutting edge 2366 cuts the target tissue. In some embodiments, one or more curved blades 2364 move and rotate. In any of the embodiments shown in FIGS. 23A and 23B, the target tissue to be cut may optionally be removed inside a curved shaft 2352 or curved blade 2364.

  Referring now to FIGS. 24A and 24B, in some embodiments, the tissue modification device may include one or more fixation members 2374 coupled to the distal shaft portion 2370 of the device. In various embodiments, many suitable securing members are used. Some embodiments of the fixing member have already been described, and other embodiments are described further below. In one embodiment, for example, the securing member 2374 includes a plurality of needles as shown in FIGS. 24A and 24B. Needle 2374 not only secures distal shaft portion 2370 relative to the tissue, but also changes one or more properties of the tissue. For example, in one embodiment, the tissue is hardened by inserting a plurality of needles into the tissue, thereby enhancing the ability of one or more tissue modifying members 2372 to cut or modify the tissue. In one example, the fixation member / needle 2374 can be placed from the distal shaft portion 2370 (arrow), and the needle 2374 is retracted when delivering the device into the patient's body and when placed in the desired location. Placed in the target organization. In various embodiments, the fixation member / needle 2374 may be in a direction substantially perpendicular to the longitudinal axis of the distal shaft portion 2370, in another suitable direction relative to the distal shaft portion 2370, or in length. Extending from the distal shaft portion 2370 in a direction that is not parallel to the longitudinal axis. In use, the protrusion that hardens the tissue extends into the target tissue. Needle 2374 typically has a greater modulus of elasticity than the target tissue, thus hardening the target tissue (ie, increasing the actual modulus of elasticity).

  In the embodiment shown in FIGS. 24A and 24B, and in the alternative embodiment described herein, one or more members, such as tissue fixation member / needle 2374, are utilized to modify tissue in various suitable ways. . For example, in some embodiments, energy is delivered to one or more tissue fixation members / needle 2374 to cool, heat, or deliver energy to the tissue. Such cooling or heating, for example, changes the stiffness or density of the tissue and thus facilitates tissue modification by one or more tissue modifying members. In one example, it is useful to increase the tissue stiffness by cooling or freezing the tissue, for example, to easily cut or polish the tissue. For example, in some embodiments, cold fluid may be delivered through the wash lumen and / or the suction / wash lumen to directly reduce the temperature of the fixation member 2374, or to individually cool the target tissue. Good. Alternatively, the tissue may be subjected to other suitable changes that enhance tissue modification procedures according to various embodiments.

  As shown in FIG. 24B, once the fixation member 2374 is placed in the target tissue, the tissue modification member 2373 (the blade in the illustrated embodiment) moves from the distal shaft portion to cut or modify the tissue. Tissue modifying member 2372 is advanced from distal shaft portion 2370 in a direction perpendicular or non-parallel to fixation member 2374. In some embodiments, the fixation member / needle 2374 holds the tissue after cutting and the tissue is removed from the patient.

  Referring to FIGS. 25A and 25B, one embodiment of a barrier 602 comprising a woven, knitted or non-woven material having a lattice structure 604 is shown. FIG. 25A shows the barrier 602 deployed from the delivery device 601 and FIG. 25B shows the barrier 602 in a fully deployed (expanded, free) configuration. In various embodiments, the barrier 602 has many suitable sizes. For example, in some embodiments, the barrier 602 has a width in the range of about 0.100 inches to about 3.000 inches, a length in the range of about 0.100 inches to about 72 inches, and about 0.001 inches. And a thickness in the range of about 0.250 inches. In some embodiments, the barrier 602 has a narrow or tapered distal end, as described in connection with FIGS. 10B and 10D above. The barrier 602 may be made by methods known in the art, such as a flat, single layer flat configuration or a bi-annular annular configuration that is pressed flat. In various embodiments, the material used to make the barrier 602 may be comprised of metal wire, monofilament, or knitted fabric. Metal wires include stainless steel (303, 304, 316, 316L), nickel titanium alloy, or cobalt chromium alloy, Elgiloy® (Elgin Specialty Metals, Elgin, Illinois, USA), Conichrome® (Pennsylvania, USA) It may be made from a suitable material such as Carpenter Technology (State Leading), or Physox® (Imphy SA, Paris, France). The woven material may be composed of polymer strands, monofilaments, or woven materials of knitted material. Polymer strands having a woven, knitted or non-woven material composition are nylon, polyester, Darcon®, polyethylene, Kevlar® (DuPont), acetal, Delrin® (DuPont), polycarbonate, nylon, silicone, polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polytetrafluoroethylene (PTFE), polyurethane, UHMWPE, or the like. In some embodiments, the barrier 602 may automatically expand after being released from the compression configuration of the delivery device 601. In some embodiments, such automatic expansion can be achieved by forming the barrier 602 from a shape memory or superelastic material.

  Referring to FIGS. 25C and 25D, in an alternative embodiment, the barrier 612 may include a plurality of slits 615 extending from opposing ends 613a, 613b toward the longitudinal center of the barrier 612. . The slits 615 may increase the flexibility of the barrier 612 by allowing the tabs 616 to be individually bent. The tabs 616 then individually return to a flat shape when the delivery device 601 is pulled proximally as shown in FIG. 25D. In some embodiments, tabs 616 are individually adapted to the surrounding tissue, thereby protecting non-target tissue. Barrier 612 may be made from suitable materials such as, but not limited to, the materials described above, and slit 615 may be die cut, milled, laser cut, EDM machined, injection molded, etched, water jet cut, and blade cut. You may form by suitable methods, such as. In alternative embodiments, the barrier 612 may be made by assembling a plurality of tabs 616 to the central member, for example, by welding, soldering, brazing, or laser welding.

  25E and 25F show another alternative embodiment of a barrier 622 that has a more centrally located slit 627 that does not extend to the lateral ends 623a, 623b.

  In another alternative embodiment, as shown in FIGS. 25G and 25H, the barrier 632 includes a central support member 639 and a plurality of lateral ribs 638 that form a framework-like framework. In various embodiments, the central member 639 and the ribs 638 comprise either the same material or different materials, and suitable materials such as, but not limited to, the materials described above may be used. In some embodiments, the ribs 638 retain the curved shape of heat treated or mechanically formed nickel titanium after deployment, as shown in FIG. 25G.

  Referring to FIGS. 25I and 25J, in another alternative embodiment, the barrier 642 may be a polymer, porous polymer, woven or non-woven cloth, metal, porous metal, foam, hydrogel, bilayer It has a flat sheet made from a polymer “bag” and produces inflatable bags and the like.

  Referring to FIGS. 25K and 25L, in another alternative embodiment, the barrier 652 includes a central support member 650 and ribs 659 that become completely straight or nearly straight when deployed. Optionally, the barrier 652 has a bend point 651 at which the barrier 652 is connected.

  FIGS. 26A and 26B show another alternative embodiment of a barrier device 832 that includes an annular woven mesh. The barrier device 832 has an elongated, low profile configuration as shown in FIG. 26A to facilitate delivery to the treatment area, and an expanded / expanded configuration that protects the tissue as shown in FIG. 26B. Become. In another embodiment, as shown in FIGS. 27A and 27B, the barrier device may comprise a flat woven mesh.

  Another alternative embodiment of the barrier device 852 is shown in FIGS. 28A and 28B. Here, the first pulling wire 854 and the second pulling wire 855 extending from the opposite ends of the portion where the shape of the barrier device 852 changes are pulled, and the portion where the shape changes expands or widens ( FIG. 28B). In some embodiments, when the pull wires 854, 855 are released, the portion that changes shape returns to its original narrow configuration (FIG. 28A).

  Referring now to FIGS. 29A and 29B, the barrier device 862 is housed in a housing 864 that includes two halves 866, 868 and a lumen that allows passage of the guide wire 869. As shown in FIG. 29B, when the halves 866, 868 are pulled separately, the barrier device 862 is free to expand.

  Referring now to FIGS. 30A-30C, in another alternative embodiment, the barrier device 892 comprises a hydrogel material that touches one or more fluids such as sarin, water, blood, and the like. And expand and / or deploy from a contracted / rolled configuration (FIG. 30A) to an expanded / deployed configuration (FIG. 30C). In one example, the hydrogel is injected directly into the area between the target and non-target tissues to form a barrier device 892, which remains in the patient's body after the tissue modification procedure is completed. In other alternative embodiments, the barrier device 892 may comprise one or more alternative automatically expanding materials or materials that expand upon contact with the fluid.

  In another embodiment, as shown in FIGS. 31A to 31C, a barrier device 872 has a knitted wire structure having a straight straight wire 874 connected to cross wires 877, 878 by a plurality of loops 876. It has. In one embodiment, the transverse wire 874 can slide freely through the loop 876 and the barrier device 872 can contract and expand. The wires 876, 877 and 878 are connected to the end caps 880 and 881 at the end of the barrier member 872. Some embodiments may also include pull tabs 879, 882 at the end of the barrier member 872. As shown in FIG. 31C, when the pull tabs 879, 882 are pulled, the barrier device 872 becomes shorter and expands to a wider configuration. As shown in FIGS. 31A and 31C, when the pull tabs 879, 882 are pulled, the angle between the cross wires 877, 878 decreases. In an alternative embodiment, pulling the pull tabs 879, 882 causes the barrier device 872 to contract. In some embodiments, the wires 874, 877, 878 themselves serve to protect the barrier member 872, while in alternative embodiments, a material or membrane is attached to the wires 874, 877, 878.

  FIGS. 32A and 32B illustrate how, in one embodiment, a barrier device 3020 extending through a delivery device 601 protects tissue during a procedure using the tissue modification device 3024 to modify the tissue. In various embodiments, the tissue modification device 3024 includes a long joule, curette, scalpel, one or more cutting blades, scissors, forceps, a probe, a demon file, a file, an abrasive member, one or more small surfaces, an electrosurgical procedure Device, bipolar electrode, monopolar electrode, thermal electrode, rotary power mechanism shaver, reciprocating power mechanism shaver, power mechanism flash, laser, ultrasonic crystal, cryogenic probe, pressurized water jet, or such device Including but not limited to combinations. The tissue modification device 3024 is freely advanced and retracted (bidirectional arrow) on one side of the barrier device 3020 and is used to modify the tissue, while the barrier device 3020 can cause untargeted tissue to cause unwanted damage. Prevent receiving. In some embodiments, the barrier device 3020 is used to guide the tissue modification device 3024 to and / or from a location where a tissue modification procedure is performed. Such guidance is realized by the shape, surface, characteristics and / or one or more guide shapes of the B rear device 3020 according to various embodiments.

  Returning to FIGS. 33A and 33B, in another embodiment, the barrier device 3030 includes an open shape changing portion 3030 and a closed elongated extension extending from either end of the shape changing portion 3030. Part 3034 and at least one guide shape 3035 extending along the length. The guide shape 3035, in various embodiments, includes one or more guidewires (as shown), rails, depressions, lumens, tracks, etc., along and / or according to the barrier device 3030. Guidance of the tissue correction device 3032 is facilitated. In various embodiments, the guide shape 3035 may comprise a separate device that is not attached to the barrier member 3030 as in the guidewire of FIGS. 33A and 33B. Alternatively, one or more guide shapes 3035 may be attached to or integrated with the barrier member 3030.

  FIG. 34 shows an embodiment of a barrier device 3050 comprising a central rail guide member 3052 along which the tissue modification device 3054 is guided. FIG. 35 shows an alternative embodiment of a barrier device 3060 comprising a central rail guide member 3062 along which the tissue modification device 3064 is guided. In some embodiments, barrier devices 3050, 3060 and tissue modification devices 3054, 3064 are advanced through delivery device 601, while other embodiments may not utilize such delivery device 601. Good.

  Referring to FIG. 36A, the barrier device 3070 includes a central channel 3072 accessible by a slit 3076 and a plurality of curved grooves 3074. The plurality of curved grooves 3074 facilitate the barrier device 3070 to contract. In another embodiment, as shown in FIG. 36B, the barrier device 3080 includes a smooth groove-free surface and a central channel 3082 accessible by the slit 3086. Slits 3076 and 3086 facilitate the tissue modification device to connect to and separate from barrier devices 3070 and 3080.

  FIGS. 37A and 37B show two additional alternative embodiments of barrier devices 3190, 3200. FIG. The barrier device 3190 includes a protruding central guide shape 3192, a flat tissue protection part 3193, and a lateral support member 3194. The barrier device 3200 includes a central indentation guide shape 3202, a flat tissue protector 3203, and a lateral support member 3204.

  As described above, in various embodiments, the barrier device comprises one or more guide shapes. In various embodiments, such guide shapes correspond to one or more guide shapes on a guide device or guide member that guides the barrier member to a desired location and / or location within the patient's body. Alternatively or additionally, one or more guide shapes on the barrier device may be used to facilitate guiding one or more tissue modification devices along, and / or through the barrier device. To. Thus, in some embodiments, the barrier member may comprise a plurality of guide shapes that guide the barrier device and guide the tissue modification device. In other embodiments, the same guide shape on the barrier device is used to guide both the barrier device and the tissue modification device. Suitable combinations of guide shapes having size, shape and pattern are used by the various embodiments.

  FIG. 38 illustrates one embodiment of a delivery device 3210 that delivers a barrier device 3220 to a patient location. In this embodiment, the barrier device 3220 includes a guide wire lumen 3221 in which a guide wire 3222 extends through the guide wire lumen and a guide shape 3223, and one or more tissue correction devices (see FIG. Pass). Optionally, the delivery device 3210 includes a visualization lumen 3216 through which the visualization device passes, a suction lumen 3214, and a cleaning lumen 3216. In alternative embodiments, the delivery device 3210 has a variety of suitable configurations and shapes. For example, in one embodiment, the suction lumen 3214 and the cleaning lumen 3216 are combined into a single lumen and a plurality of visualization lumens 3216 are combined.

  As described above, in many of the illustrated embodiments, the barrier device comprises one or more pieces of material. Such materials include suitable materials or combinations, and in some embodiments rubber (Vaiton), nylon, silicone, ether ether ketone (PEEK), polyether ketone ketone (PEKK), polytetrafluoro. Ethylene (PTFE), Polyurethane (Tecothane), Pebax (US company), Polycarbonate, Derlin (US company), High density polyethylene (HDPE), Low density polyethylene (LDPE), High molecular weight polyethylene (HMWPE), Ultra high molecular weight It may be made from various embodiments of one or more polymer materials such as polyethylene (UHMWPE). This material can be coated, laminated, infiltrated, covered, or molded on a barrier device, alternatively by adhesives or bonding agents, by heat bonding techniques, fasteners such as clasps or threads Or by forming pockets in the material that match the ribs of the barrier.

  In other embodiments, one or more conductive wires are incorporated into the barrier device and the wires are placed and selectively operate along one or both of the target tissue surfaces of the barrier device or the surface of the non-target tissue. To be exposed / exposed. In one embodiment, for example, a wire is coupled to a lateral support member of the barrier device. For example, using conductive wires to stimulate and identify specific tissues such as nerves, and / or monitor the location / location of barrier devices by measuring electrical resistance and / or propagating currents that stimulate target tissue To do. In one embodiment, an array of wire contact points along the barrier device is implemented and activated individually to verify that the barrier device is in the desired position / location.

  Referring now to FIG. 39, in some embodiments, a tissue modification device 3600 includes an elongated body 3602 that is at least partially flexible, an abrasive tissue modification surface 3604, a proximal handle 3606, and A distal handle 3608. As described above, the polishing surface 3604 includes various polishing members, configurations, and the like such as, but not limited to, a file. Examples of various polishing surfaces / files are described in more detail, for example, in international patent application PCT / US2005 / 037136, which has already been incorporated by reference. For example, an embodiment having a polished surface or a filed surface is attached to FIGS. 34, 35, 41, 42, 48, 61, 62, 64, 86-99, 101 and 102 of International Patent Application PCT / US2005 / 037136. Is shown in the detailed description.

  In use, the distal end of the elongate body 3602 is advanced through the patient's back into the epidural space between the target and non-target tissues and exits from the patient's back, as shown in FIG. The distal handle 3608 is then removably coupled to the distal end of the elongated body 3602 (in the alternative embodiment near the distal end). Next, the user grasps the proximal handle 3606 and the distal handle 3608 and pulls both to apply tension (an arrow pointing upward with a solid tip) to press the polishing surface 3604 against the target tissue. The user also uses the handles 3606, 3608 to move the elongated body back and forth (two-way arrow) and polish the target tissue with the polishing surface 3604. During a procedure to modify a given tissue, tension is applied by pulling the individual bundles 3606, 3608 in different or the same direction. In some procedures, the handles 3606, 3608 are moved to apply tension from different angles and directions during the procedure. “Individual handles” as described above means that the handles 3606, 3608 are not connected to each other by a common handle or other connecting device or mechanism. Clearly, however, the handles 3606, 3608 are coupled to the elongated body 3602 (in other embodiments, a guard) at or near the distal and proximal ends or distal and proximal portions. (In some embodiments, removably coupled).

  In various embodiments, the elongated body 3602 has any suitable size. In some embodiments, the elongate body 3602 is long enough to pass from outside the patient's body through a passage in the spinal column, such as an intervertebral foramen, through an exit point away from the entry point and out of the patient's body. Have The elongated body 3602 typically has a width such that the abrasive surface 3604 does not completely cut the bone when the body 3602 moves under tension. For example, in one embodiment, the body 3602 has a width of about 3 mm or less, preferably about 5 mm or less (at least along the portion where the polishing surface 3604 is disposed). The body 3602 has a height that facilitates passage between target and non-target tissues in the patient's body. For example, in one embodiment, the body 3602 has a height of about 4 mm or less, preferably about 2 mm or less.

  In some embodiments, the polishing surface 3604 is disposed along one side of the elongate body and along a limited length of the elongate body 3602 so that the non-target as the elongate body 3602 moves. Prevent or minimize undesired damage near the tissue. For example, in some embodiments, the polishing surface 3604 is disposed along the length of the device of 10 cm or less, preferably 6 cm or less, and more preferably 3 cm or less. In an alternative embodiment, the polishing surface 3604 extends substantially along or along the entire length of the elongated body 3602 and / or is provided on multiple sides of the elongated body 3602. In one embodiment, for example, all of the elongate body 3602 includes a polishing surface 3604, and at least a portion of the elongate body 3602 is disposed within the protective or barrier member, and non-target tissue is damaged during the procedure. To prevent. However, some embodiments have at least one non-abrasive side or surface proximate the polishing surface 3604 to protect non-target tissue from undesirable damage. In some embodiments, such a non-abrasive surface may optionally be made of a smooth or low friction material and / or coated with a smooth or low friction coating.

  In various embodiments, the proximal handle 3606 and the distal handle 3608 have any size, shape, or configuration. Indeed, in various embodiments, the distal handle 3608, the proximal handle 3606, or both may be combined. In FIG. 39, the proximal handle 3606 is shown as a handle that can be gripped with a trigger used with a blade, RF, or other movable tissue modifying member as described above. Such a grippable handle 3606 is not necessary in all embodiments, but some polishing / filer devices 3600 may be replaced with blade devices and / or RF devices, etc. during a tissue modification procedure. Used in the examples. Thus, in some embodiments, the graspable proximal handle 3606 is removably coupled to the elongate body 3602, and various alternative tissue modification members are utilized with the same proximal handle 3602. The In such an embodiment, for example, the target tissue is modified by a file of an elongated body 3602 and further modified using an RF device, a blade device, a power device, or the like. In various embodiments, such devices are used in any order. Similarly, distal handle 3608 is utilized with one or more devices.

  In some embodiments, the tissue modification device 3600 further comprises one or more electrodes (not shown) coupled to or in close proximity to the abrasive surface 3604 and / or the non-abrasive surface of the elongate body 3602. Yes. Such an electrode is operated, for example, by a trigger or button on the proximal handle 3606 to examine the position of the polishing surface 3604 within the patient's body. For example, if the user believes that the polishing surface 3604 is in a position to treat the target tissue, the electrode on the polishing surface 3604 is activated. If the abrasive surface 3604 actually touches the neural tissue that the user does not want to treat or injure, the patient's leg should cramp or move suddenly and the abrasive surface 3604 should be repositioned and the treatment should be discontinued To the user. Alternatively or additionally, the patient's evoked EMG response is monitored to determine whether the working electrode is in contact with or near neural tissue. In another example, when the electrode is placed on the non-abrasive surface and operating, it indicates that the non-abrasive surface faces the non-target tissue as intended. In various embodiments, any combination of electrodes is utilized. Furthermore, a description of such electrodes and their use can be found in the international patent application PCT / US2005 / 037136.

  Referring now to FIGS. 40A through 40D, in various embodiments, the file or polishing surface of the tissue modification device includes various suitable configurations, sizes, and / or various file members and the like. Such various polishing surfaces are described, for example, in FIGS. 90 to 96 of the already incorporated international patent application PCT / US2005 / 037136 and the accompanying detailed description. The examples shown in FIGS. 40A-40D are further examples of file / polishing surface configurations according to various examples.

  In one embodiment, as shown in FIG. 40A, a diagonally shaped file member 3624 having a plurality of notches 3626 is disposed along one side of the elongated body 3622 of the tissue modification device. Of course, in various embodiments, the file member 3624 may have many curved portions, or may have other alternative shapes or configurations. In alternative embodiments, the file member 3624 may be made from any of the materials previously described for alternative embodiments of the tissue modifying member. For example, in some embodiments, the file member 3624 may have a hard end and may be composed of a material such as stainless steel or titanium, while in other embodiments, the file member 3624 may include: You may make it as polished surfaces, such as a diamond and tungsten carbide. In yet another embodiment, a knitted wire, such as a knitted wire used in a Gigli saw, is bonded to the surface of the elongated body 3622 to form a file member 3624. Obviously, the file member 3624 may have a variety of configurations and may be made from any suitable material, and thus the file member 3624 is not limited to the examples described herein.

  FIG. 40B shows an alternative embodiment where a file member 3634 and a plurality of channel openings 3636 are disposed along the elongated body 3632 of the tissue modification device. In such an embodiment, tissue to be abraded by the file member 3634 enters the hollow portion (or multiple hollow portions) of the elongated body 3632 through the channel opening 3636. In various embodiments, the removed tissue is stored in any such channel and removed when the tissue modification device is removed from the patient, or alternatively, washed, aspirated, or a combination thereof. In use, it is removed from the elongated body 3632.

  In another example, as shown in FIG. 40C, the file portion 3644 disposed along the elongated body 3642 includes various file members 3646 and optionally various channel openings 3648. In some embodiments, the file member 3646 may include a cutting edge that faces in the same direction. In such embodiments, the file member 3646 polishes or cuts tissue when the elongated body 3642 moves in one direction and does not polish or cut tissue when moved in the opposite direction. In various embodiments, the file member 3646 is configured to deliver tissue to the channel opening 3648.

  FIG. 40D shows another embodiment of a filed portion 3654 positioned along the elongated body 3652 of the tissue modification device. The file portion 3654 further includes a plurality of file members 3656 and a plurality of channel openings 3658, but in this embodiment, the file members 3656 have alternate rows of oppositely oriented cutting edges. Thus, when the elongated body 3652 moves back and forth, the file member 3656 abrades or cuts the tissue when the elongated body 3652 moves in both directions.

  Referring now to FIG. 41, in an alternative embodiment, tissue modification device 3700 includes an elongated body 3702 that is at least partially flexible, at least a portion of which is along the length. And disposed within a protective member 3710 (or “barrier member”) having an opening 3712. The elongate body 3702 includes at least one polishing surface 3704, which includes a file or other polishing surface as described above, exposed through the opening 3712 and contacting the target tissue. To polish. In various embodiments, the tissue modification device 3700 includes a proximal handle 3706 and a distal handle 3708, one or both of which are removably coupled to the elongated body 3702. Optionally, the protection member 3710 may include a proximal fixation member 3714 and / or a distal fixation member 3716 to secure the protection member 3710 outside the patient's body. In alternative embodiments, proximal handle 3706, distal handle 3708, or both are coupled to protective member 3710 rather than body 3702.

  In use, the protective member 3710 passes through the patient's back, enters the epidural space between the target tissue and the non-target tissue, and exits the patient's back. In various embodiments, the elongate body 3702 may enter the patient's body with the protective member 3710, or may pass through the protective member after the protective member 3710 has been deployed. In another embodiment, the elongated body 3702 initially enters the patient's body, and the protective member 3710 enters the patient's body along the elongated body. A polishing surface 3704 is disposed and exposed and / or protrudes through an opening 3712 on the protective member 3710 to contact the target tissue. Tension is applied to the protective member 3710, the elongated body 3702, or both to move the polishing surface 3704 toward the target tissue. For example, in some embodiments, tension is applied by gripping or pulling handles 3706, 3708, while in other embodiments, tension is applied by gripping or pulling the distal and proximal portions of protective member 3710. Take it. The fixing members 3714 and 3716 may be connected to the protective member 3710 at several positions before or after applying the tension, or may be deployed from now on. Various alternative embodiments may include only the proximal fixation member 3714 or only the distal fixation member 3716 and pull the unsecured end 3714 of the protective member 3714 to provide tension. May be added. The fixation members 3714, 3716 may comprise any suitable device for fixing or exerting force against the patient's skin, some of these exemplary embodiments are described above in connection with FIG. 6A. In alternative embodiments, the fixation members 3714, 3716 may be attached to one or more devices such as operating table rails remote from the patient. In other alternative embodiments, the protective member 3710 may be fixed in a relatively stable state by gripping one or both of its ends. In other embodiments, the protective member 3710 may be fixed in a relatively stable state simply by placing it on the patient's own skin. In a further alternative embodiment, both the protective member 3710 and the body 3702 may be fixed in a relatively stable manner, and one or more actuation portions on the proximal handle 3706 and / or the distal handle 3708 may be It may be used to move or actuate the polishing surface 3704 to polish the target tissue.

  The elongated body 3702 may move back and forth via the protective member 3710 so that the polishing surface 3704 polishes the target tissue. Since the protective member 3710 typically protects non-target tissue from undesired damage, the polishing surface 3704 may be disposed along the elongated body at a desired length and / or the total circumference of the elongated body 3702. Or almost all of them may be arranged. In some embodiments, for example, the polishing surface 3704 may extend the entire length of the elongated body 3702. In practice, in some embodiments, the elongated body 3702 may comprise a file or bladed wire saw or the like. In some embodiments, the protective member 3710 may include one or more protective materials, multi-layer materials, etc. (not shown) along the ends of the one or more openings 3712, with the elongated body 3702 being front and rear. This prevents damage to the end of the opening 3712 when moving.

  In various embodiments, the protective member 3710, the elongated body 3702, or both, may include additional features that enhance tissue modification procedures to treat or alleviate spinal stenosis. For example, in various embodiments, the protective member 3710 and / or the elongated body 3702 may include one or more lumens for aspiration and / or irrigation to help remove tissue debris from the patient. In various embodiments, such debris may pass through one or more lumens in the protective member 3710, through one or more lumens in the elongated body 3702, or between the protective member 3710 and the elongated body 3702. May be removed. Optionally, one or more electrodes may be disposed on the protective member 3710, the elongated body 3702, the polishing surface 3704, or a combination thereof, so that the device 3700 is in a desired position on the patient, as described above. The user can confirm that there is. Various other features may be added in various embodiments.

  42A and 42B, in another embodiment, the tissue modification device 800 includes an elongated body 802, a wide tissue modification 806 having a polishing surface 808, a tapered 810, and an unpolished surface 816. A proximal handle 812 and a distal handle 814 (FIG. 42B shows a side view of a portion of the device 800). In one embodiment, the elongated body 802 includes a metal wire and the tissue modification 806 includes a wide portion connected to the wire. The body 802, tissue modifying portion 806, etc. have a suitable size and configuration, and the polishing surface 808 has a suitable configuration, examples of which have been described in more detail above, and have already been by reference. Incorporated international patent application PCT / US2005 / 037136. In various embodiments, the body 802 may be coupled to the tissue modification 806 using any technique such as welding, adhesive attachment, and the like. In an alternative embodiment, the body 802 and the tissue modifier may be formed from a single material. Optionally, the body 802 and / or the tissue modification 806 may comprise one or more lumens, such as a guidewire lumen, a suction lumen, and / or a cleaning lumen. The device 800 may also include additional features described above in connection with the protective member, one or more electrodes, and other embodiments.

  While various exemplary embodiments have been described, many changes may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. Therefore, the above description should not be taken as limiting the scope of the invention which is described by the claims.

FIG. 1 is a cross-sectional view of the spinal column showing the plane of the lumbar spine and the cross section of the horsetail and two existing nerve roots. FIG. 2 is a partial cross-sectional view of a patient's back and spine showing a portion of a vertebra and a deployed tissue modification device according to one embodiment of the present invention. FIG. 3A is a perspective view of a tissue correction device according to an embodiment of the present invention. 3B is a perspective view of a portion of the tissue modification device of FIG. 3A. FIG. 3C is a front view of the portion shown in FIG. 3B. FIG. 3D is a side view of the portion shown in FIGS. 3B and 3C. 3E is a cross-sectional view of a portion of the tissue modification device along line AA shown in FIG. 3C. 3F is a cross-sectional view of a portion of the tissue modification device along line BB shown in FIG. 3C. FIG. 3G is a perspective view of a portion of the tissue modification device of FIGS. 3B through 3F, showing the blade of the device of one embodiment according to the present invention closed. FIG. 3H is a front view of the portion shown in FIG. 3G. FIG. 3I is a side view of the portion shown in FIGS. 3G and 3H. FIG. 4A is a perspective view of a tissue correction device according to an embodiment of the present invention. FIG. 4B is a perspective view of the tissue correction device according to one embodiment of the present invention. FIG. 4C is an enlarged perspective view of a part of the tissue correction device of FIGS. 4A and 4B showing the tissue correction device according to one embodiment of the present invention. FIG. 5A is a cross-sectional view of the spinal column showing a method of using the tissue modification device according to one embodiment of the present invention. FIG. 5B is a cross-sectional view of the spinal column showing a method of using the tissue modification device according to one embodiment of the present invention. FIG. 5C is a cross-sectional view of the spinal column showing a method of using the tissue modification device according to one embodiment of the present invention. FIG. 5D is a cross-sectional view of the spinal column showing a method of using the tissue modification device according to one embodiment of the present invention. FIG. 6A is a cross-sectional view of a portion of a patient's spine and back, wherein a tissue modification device according to one embodiment of the present invention is positioned to modify the tissue of the spine and is distal to the device. The part is fixed outside the patient's body. 6B is a cross-sectional view of a portion of a patient's spine and back, wherein a tissue modification device according to one embodiment of the present invention is positioned to modify the tissue of the spine and is distal to the device. The part is fixed in the patient's body. FIG. 7A is a cross-sectional view of a portion of a patient's spine and back, and a method of introducing a device for modifying spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7B is a cross-sectional view of a portion of a patient's spinal column and back, and a method for introducing a device for correcting spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7C is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7D is a cross-sectional view of a portion of a patient's spinal column and back, and a method for introducing a device for correcting spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7E is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue into a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7F is a cross-sectional view of a portion of a patient's spinal column and back, and a method for introducing a device for correcting spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7G is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7H is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue into a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7I is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7J is a cross-sectional view of a portion of a patient's spinal column and back, and a method for introducing a device for correcting spinal tissue to a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7L is a cross-sectional view of a portion of a patient's spinal column and back, and a method for introducing a device for correcting spinal tissue into a region in the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7K is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7M is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7N is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue into a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 7O is a cross-sectional view of a portion of a patient's spine and back, and a method for introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue correction according to one embodiment of the present invention. Is shown. FIG. 8A is a cross-sectional view of a portion of a patient's spine and back, introducing a device for modifying spinal tissue to an area within the spinal column to perform tissue correction according to an alternative embodiment of the present invention. Shows how to do. FIG. 8B is a cross-sectional view of a portion of a patient's spine and back, introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue modification according to an alternative embodiment of the present invention. Shows how to do. FIG. 8C is a cross-sectional view of a portion of a patient's spine and back, introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue modification according to an alternative embodiment of the present invention. Shows how to do. FIG. 8D is a cross-sectional view of a portion of a patient's spine and back, introducing a device for correcting spinal tissue to a region within the spinal column to perform tissue correction according to an alternative embodiment of the present invention. Shows how to do. FIG. 8E is a cross-sectional view of a portion of a patient's spine and back, introducing a device for modifying spinal tissue to a region within the spinal column to perform tissue modification according to an alternative embodiment of the present invention. Shows how to do. FIG. 8F is a cross-sectional view of a portion of a patient's spine and back, and introduces a device for modifying spinal tissue to a region within the spinal column to perform tissue modification according to an alternative embodiment of the present invention. Shows how to do. FIG. 8A is a cross-sectional view of a portion of a patient's spine and back, introducing a device for modifying spinal tissue to an area within the spinal column to perform tissue correction according to an alternative embodiment of the present invention. Shows how to do. FIG. 9B is a cross-sectional view of a portion of a patient's spine and back, introducing a device for modifying spinal tissue to an area within the spinal column to perform tissue modification according to an alternative embodiment of the present invention. Shows how to do. FIG. 10A is a perspective view of the distal portion of the introducer sheath according to one embodiment of the present invention. FIG. 10B is a perspective view of a tissue protection device according to one embodiment of the present invention. FIG. 10C is a cross-sectional view of a tissue protection device according to one embodiment of the present invention. FIG. 10D is a perspective view of a tissue protection device according to another embodiment of the present invention. FIG. 10E is a cross-sectional view of a tissue protection device according to another embodiment of the present invention. FIG. 11A is a cross-sectional view of a spinal column with tissue modification devices in accordance with various embodiments of the present invention positioned to modify tissue. FIG. 11B is a cross-sectional view of a spinal column with tissue modification devices in accordance with various embodiments of the present invention positioned to modify tissue. FIG. 12 is a cross-sectional view of a portion of a spinal column with a tissue modification device in accordance with an alternative embodiment of the present invention positioned to modify tissue. FIG. 13A is a cross-sectional view of a portion of a spinal column with a tissue modification device in accordance with various embodiments of the present invention positioned to modify tissue. FIG. 13B is a cross-sectional view of a portion of the spinal column with tissue modification devices in accordance with various embodiments of the present invention positioned to modify tissue. FIG. 13C is a cross-sectional view of a portion of the spinal column with tissue modification devices in accordance with various embodiments of the present invention positioned to modify tissue. FIG. 13D is a cross-sectional view of a portion of the spinal column with tissue modification devices in accordance with various embodiments of the present invention positioned to modify tissue. FIG. 13E is a cross-sectional view of a portion of the spinal column with tissue modification devices in accordance with various embodiments of the present invention positioned to modify tissue. 13F is a cross-sectional view of a portion of the tissue modification device of FIG. 13E taken along line CC of FIG. 13E in various configurations of the present invention. 13G is a cross-sectional view of a portion of the tissue modification device of FIG. 13E taken along line CC of FIG. 13E in various configurations of the present invention. FIG. 14 is a cross-sectional view of a portion of a spinal column with a tissue modification device having a movable distal portion according to one embodiment of the present invention positioned to modify tissue. FIG. 15A is a cross-sectional view of a portion of the spinal column with a tissue modification device in accordance with one embodiment of the present invention positioned to modify tissue. FIG. 15B is an enlarged view of a portion DD in FIG. 15A. FIG. 16 is a cross-sectional view of a portion of the spine with the tissue modification device in accordance with one embodiment of the present invention positioned to modify tissue. FIG. 17A is a cross-sectional view along line AA of FIG. 16 in accordance with various alternative embodiments of the present invention. FIG. 17B is a cross-sectional view along line AA of FIG. 16 according to various alternative embodiments of the present invention. 17C is a cross-sectional view along line AA of FIG. 16 in accordance with various alternative embodiments of the present invention. FIG. 17D is a cross-sectional view along line AA of FIG. 16 in accordance with various alternative embodiments of the present invention. FIG. 17E is a cross-sectional view along line AA of FIG. 16 in accordance with various alternative embodiments of the present invention. 18 is a cross-sectional view taken along line BB in FIG. 16 according to one embodiment of the present invention. FIG. 19A is a perspective view of the distal portion of a tissue modification device in accordance with various alternative embodiments of the present invention. FIG. 19B is a perspective view of the distal portion of a tissue modification device in accordance with various alternative embodiments of the present invention. FIG. 19C is a perspective view of the distal portion of a tissue modification device in accordance with various alternative embodiments of the present invention. FIG. 20 is a perspective view of the distal portion of a tissue modification device in accordance with various alternative embodiments of the present invention. FIG. 21 is a perspective view of the distal portion of a tissue modification device in accordance with various alternative embodiments of the present invention. FIG. 22 is a perspective view of the distal portion of a tissue modification device in accordance with various alternative embodiments of the present invention. FIG. 23A is a perspective view of the distal portion of a tissue modification device according to an alternative embodiment of the present invention. FIG. 23B is a perspective view of the distal portion of a tissue modification device according to an alternative embodiment of the present invention. FIG. 24A is a side view of the distal portion of the tissue modification device according to one embodiment of the present invention. FIG. 24B is a side view of the distal portion of the tissue modification device according to one embodiment of the present invention. FIG. 25A is a perspective view of a mesh type barrier device arranged from a sheath according to an embodiment of the present invention. FIG. 25B is a plan view of the mesh-type barrier device of FIG. 25A and shows a free state before installation on the sheath. FIG. 25C is a perspective view of a flexible tab type barrier device deployed from a sheath according to an alternative embodiment of the present invention. FIG. 25D is a plan view of the tab-type barrier device of FIG. 25C and shows a free state before being installed on the sheath. FIG. 25E is a perspective view of a slit-type barrier device disposed from a sheath according to an alternative embodiment of the present invention. FIG. 25F is a plan view of the slit-type barrier device of FIG. 25E and shows a free state before being installed on the sheath. FIG. 25G is a perspective view of a rib-type barrier device disposed from a sheath according to an alternative embodiment of the present invention. FIG. 25H is a plan view of the rib-type barrier device of FIG. 25G and shows a free state before installation on the sheath. FIG. 25I is a perspective view of a sheet-type barrier device placed from a sheath according to an alternative embodiment of the present invention. FIG. 25J is a plan view of the sheet-type barrier device of FIG. 25I and shows a free state before installation on the sheath. FIG. 25K is a perspective view of a bar-type barrier device deployed from a sheath according to an alternative embodiment of the present invention. FIG. 25L is a plan view of the bar-type barrier device of FIG. 25K and shows a free state before installation on the sheath. FIG. 26A is a perspective view of a low profile knitted cylindrical barrier device according to an embodiment of the present invention. FIG. 26B is a perspective view of an expanded knitted cylindrical barrier device according to one embodiment of the present invention. FIG. 27A is a perspective view of a low profile knitted flat barrier device according to one embodiment of the present invention. FIG. 27B is a perspective view of an expanded knitted flat barrier device according to one embodiment of the present invention. FIG. 28A is a perspective view of a barrier device having a low profile pulling mechanism according to one embodiment of the present invention. FIG. 28B is a perspective view of a barrier device having an extended tension mechanism according to an embodiment of the present invention. FIG. 29A is a perspective view of a cylindrical housing for a barrier device in an undeployed state according to one embodiment of the present invention. FIG. 29B is a perspective view of the cylindrical housing shown in FIG. 29A according to one embodiment of the present invention, in which the barrier device is deployed from the housing. FIG. 30A is a perspective view of a hydrogel material barrier device during a deployment / expansion operation after exposure to a liquid according to one embodiment of the present invention. FIG. 30B is a perspective view of a hydrogel material barrier device during a deployment / expansion operation after exposure to liquid, according to one embodiment of the present invention. FIG. 30C is a perspective view of a barrier device for a hydrogel material during deployment / expansion operation after exposure to liquid, according to one embodiment of the present invention. FIG. 31 is a perspective view and a side view of a barrier device comprising a plurality of curved elements according to an embodiment of the present invention. FIG. 32A is a perspective view of a barrier device and a tissue correction device according to an embodiment of the present invention. FIG. 32B is a perspective view of the barrier device and the tissue correction device according to one embodiment of the present invention. FIG. 33A is a perspective view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 33B is a perspective view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 34 is a perspective view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 35 is a perspective view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 36A is a cross-sectional view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 36B is a cross-sectional view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 37A is a cross-sectional view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 37B is a cross-sectional view of a barrier device and tissue modification device according to an alternative embodiment of the present invention. FIG. 38 is a cross-sectional view of a barrier device and delivery device according to an alternative embodiment of the present invention. FIG. 39 is a side view of a tissue correction file device according to an embodiment of the present invention and a cross-sectional view of a spinal column. FIG. 40A is a perspective view of various polishing tissue correction portions of a tissue correction file device according to various embodiments of the present invention. FIG. 40B is a perspective view of various polishing tissue correction portions of a tissue correction file device according to various embodiments of the present invention. FIG. 40C is a perspective view of various polishing tissue correction portions of a tissue correction file device according to various embodiments of the present invention. FIG. 40D is a perspective view of various polishing tissue correction portions of a tissue correction file device according to various embodiments of the present invention. FIG. 41 is a side view of a tissue correction file device including a barrier member according to an embodiment of the present invention. FIG. 42A is a perspective view of a tissue correction file device according to an alternative embodiment of the present invention. FIG. 42B is a partial side view of a tissue correction file device according to an alternative embodiment of the present invention.

Claims (11)

A device for modifying tissue in a patient's spinal column to treat or alleviate spinal stenosis, comprising:
At least a partially flexible elongated body having a proximal portion and a distal portion;
At least one polishing surface disposed along a portion of one side of the elongated body;
At least one non-polishing surface disposed near the polishing surface so as to face the non-target tissue when the polishing surface is arranged to face the target tissue;
At least one proximal tension member coupled to the elongated body at or near the proximal portion to facilitate applying and transmitting tension to the elongated body;
At least one coupled to the elongated body at or near the distal portion and not directly coupled to the proximal tension member to facilitate applying and transmitting tension to the elongated body . apparatus characterized by comprising a distal tension member. The apparatus of claim 1, wherein the elongated body has a width of 5 mm or less and a height of 2 mm or less . The apparatus of claim 1, wherein the at least partially flexible elongate body is sized to pass between target and non-target tissue within the epidural space of the patient's spinal column. A device characterized by that . The device of claim 1, wherein the elongate body is a guidewire lumen, rail, track, or longitudinal impression along which the device passes over the delivery device. A device comprising at least one of the recesses . The device of claim 1, wherein the at least one polished surface comprises a demon file . The device of claim 1, wherein the at least one polishing surface comprises a cutting edge . 2. The apparatus of claim 1, wherein each of the proximal and distal tension members comprises at least one of a handle, an uneven gripping surface, a wide portion of the body, and a shaped portion of the body. A device characterized by . The apparatus of claim 1, wherein at least one of the proximal and distal tension members is removably attached to the elongate body . The apparatus of claim 1, further comprising at least one protective member coupled to the elongate body to protect the non-target tissue from damage during a tissue modification procedure. Equipment . The apparatus of claim 9, further comprising at least one electrode coupled to the protection member for inspecting the position of the protection member . The apparatus of claim 1, further comprising at least one electrode coupled to the apparatus at or near at least one of the polishing surface and the non-polishing surface to inspect the apparatus. Features device .

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