JP2015519128A - Deflectable tissue destruction device - Google Patents

Abstract

The tissue disrupting element comprises an elongated tissue disrupting element that is rotatable and deflectable about its central axis, the central axis being the longitudinal axis when the disrupting element is straight. The tissue disrupting element is rotatably fixed in a distal position and can deflect to a curved configuration. The rotational drive rotates the tissue disrupting element about its central axis in a straight configuration with a curved configuration. The elongated element wraps tightly around the tissue disrupting element. In some embodiments, the elongate element protrudes sufficiently radially from the tissue disrupting element, and rotation of the tissue disrupting element results in axial movement of the disrupted tissue. In a preferred embodiment, the tissue disrupting element and / or the elongate element comprises a wire mesh. [Selection] Figure 1

Description

  The present invention relates generally to an apparatus and method for disrupting tissue, and more particularly to an apparatus and method for disrupting tissue with a flexible element that disrupts tissue, such as a shaft.

Minimally invasive and percutaneous procedures are performed through small holes in the skin, but limit the size of surgical tools and grafts used.
A graft tissue having a small cross-section is used to be easily inserted into a small hole in the skin and formed into a final functionally expanded shape at the intended implantation site in the body.

In a minimally invasive procedure, open the space for the transplanted tissue by destroying the tissue to initially insert the grafted tissue for spinal surgery such as interbody fusion, motion preservation and spinal augmentation It is necessary.
Although a tissue destruction process is required, it can cause trauma and inevitably destroy tissue.
It is important to be able to predetermine the amount and location of tissue to be destroyed.

  In addition, precise control of the location of the transplanted tissue for spinal surgery is critical to the success or failure of the spine surgery. Undesirable movement of the transplanted tissue after placement, improper placement, improper or inaccurate opening, expansion or other shaping after insertion of the transplanted tissue may result in the implant not being in the exact position intended by the user, There may be incomplete fusion. Another problem is to avoid effects on the spinal cord due to the destruction of the transplanted tissue or tissue. The 1 millimeter difference turns an otherwise successful operation into a failed operation. Many prior art methods and devices have been developed to control the precise placement and opening of the transplanted tissue, such as for use in surgery (eg, spinal surgery).

  An additional problem is that even if the surgeon properly inserts the graft, the graft may not do what is desired. For example, even if the transplanted tissue sinks (sinks) into the bone tissue, even if the transplanted tissue deflects and thereby displaces the space between the vertebral bodies to a certain height. The presence and its deflection are not translated into the desired distance between adjacent vertebral bodies because the transplanted tissue has subsided.

  An additional problem is the need to remove the destroyed tissue without causing further trauma.

  There is an urgent need for a tissue disruption device that can control the location and amount of tissue destroyed. It would be very effective if such an apparatus and method solved the above problems.

  One feature of the present invention is a tissue disruption device that is rotatable and deflectable about its central axis and comprises an elongated tissue disrupting element, the central axis being in a state where the disrupting element is straight. In some cases, the longitudinal axis, the tissue disruption element is rotatably fixed in a distal position, can be deflected into a curved configuration, and the tissue disruption around its central axis is straight in the curved configuration The rotational drive is configured to rotate the element.

  A further feature of the present invention is a method for disrupting a target tissue in a human or animal body, which method rotatably locks a displaceable elongated tissue disrupting element to a support element in a distal position. (The tissue disrupting element is rotatable about its central axis, which is the longitudinal axis when the tissue disrupting element is in a straight state) and deflectable elongated tissue disruption Introducing the element and support element into the body and deflecting the tissue disruption element into a curved configuration while rotating the tissue disruption element about its central axis to destroy the target tissue.

Yet another feature of the present invention is a method of disrupting human or animal intervertebral disc tissue, the method comprising the following steps.
(A) inserting a deflectable and elongated tissue disrupting element into a human or animal body, the tissue disrupting element being rotatable about its central axis, the central axis being straight with the tissue disrupting element When in the state, the longitudinal axis, the tissue disrupting element is mounted in a distal position.
(B) the tissue disruption element is rotated about its central axis and attached to the distal portion to destroy an amount of tissue in the space occupied by the disc, leaving at least an arcuate portion of the disc tissue; Deflecting the tissue disrupting element into a curved configuration while in contact.
(C) inserting the graft so that the graft is adjacent to at least the arcuate portion of the disc tissue;

Yet another feature of the present invention is a method of disrupting human or animal intervertebral disc tissue, the method comprising the following steps.
(A) inserting a deflectable and elongated tissue disrupting element into a human or animal body, the tissue disrupting element being rotatable about its central axis, the central axis being straight with the tissue disrupting element When in state, the longitudinal axis, the tissue disrupting element is mounted in a distal position, and the tissue disrupting element has an elongated element that is tightly wound in a spiral.
(B) Predetermining the amount and location of tissue to be destroyed by configuring a support element attached to the tissue destruction element.
(C) while the tissue disruption element is rotating about its central axis to disrupt an amount of tissue in the space occupied by the disc, leaving at least an arcuate portion of the tissue of the disc in the tissue disruption element Deflecting the tissue disrupting element into a curved configuration;

  These and other features, aspects and advantages of the present invention will be better understood with reference to the following drawings, description and claims.

Various embodiments are now described with reference to the accompanying drawings, by way of example only.
FIG. 1A is an isometric view of a straight tissue disruption device in one embodiment of the present invention; FIG. 1B is an isometric view from above of the device of FIG. 1A, showing the two degrees of freedom of the tissue disruption device and assembly in an embodiment of the present invention. FIG. 2A is an embodiment of the present invention, an isometric view of a tissue disruption device, where the tissue disruption element (and assembly) is in a curved configuration and drives the tissue disruption element (and assembly) in a wide range. It is a fixed joint. FIG. 2B is a diagram of the tissue disruption device of FIG. 2A and is one embodiment of the present invention, where the tissue disruption element (and assembly) swings in a curved configuration. FIGS. 3A and 3B are isometric views of a tissue disruption device having a rotating drive and handle and an integrated support element in one embodiment of the present invention. ; FIG. 4 is an enlarged view of the distal portion of FIGS. 3A-B of the extruded portion of the support element according to one embodiment of the present invention. FIG. 5 is an enlarged view similar to FIG. 4, with the extruding portion of the tissue disrupting element and the flexible shaft removed, corresponding to a wide support element FIG. 6 is a top view of a disc (“VB”) that includes a disc annulus and nucleus pulposus according to one embodiment of the present invention, showing a distal portion of a tissue disruption device partially positioned in place in the disc Show. FIG. 7 is a view similar to FIG. 6 except showing more than the distal portion of the device positioned in place, in accordance with one embodiment of the present invention. 6-7 with the distal portion of the device completely in place, where the tissue disruption element (and assembly) in a straight state is hidden from view, according to one embodiment of the present invention. It is a similar figure. FIG. 9 is a view similar to FIG. 8 except revealing tissue disruption elements (and assemblies) that are deflected into a curved configuration, in accordance with one embodiment of the present invention. A distal portion of a tissue disruption device (10) comprising a tissue disruption element (20) that is horizontally (laterally) deflected in a curved configuration with the aid of a C-shaped support element, according to one embodiment of the present invention. 10A) is an end view. A distal portion (10A) of a tissue disruption device (10) comprising a C-shaped support element and the rest of a tissue disruption device including a tissue disruption assembly, a fixation pivot, and a portion of the support element, according to one embodiment of the present invention. ). 1 is an end view of a distal portion (10A) of a tissue disruption device (10), according to one embodiment of the present invention. FIG. 1 is an isometric view of a wire mesh that is wound helically around a central axis of a tissue disruption device and forms a tissue disruption element, according to one embodiment of the present invention. FIG. FIG. 12 is a side view of an exemplary section of the wire mesh tissue disruption assembly shown in FIG. 11 according to one embodiment of the present invention. 1 is an isometric view of a wire mesh that fits on a flexible shaft, according to one embodiment of the present invention. FIG. FIG. 12 is an isometric view of a wire mesh as in FIG. 11 that is not fitted on a flexible shaft with differently shaped wires that are curved, such as having a V-shaped cross section, in accordance with an embodiment of the present invention. 6 is a flowchart illustrating a method according to one embodiment of the present invention. Figure 6 is a flow chart illustrating a further method according to one embodiment of the present invention. Fig. 6 is a flow chart illustrating a further method according to one embodiment of the present invention. FIG. 6 is a schematic isometric view of an alternative implementation of a tissue disruption element that includes a plurality of rotating segments in each of a linear shape and an arcuate shape, in accordance with one embodiment of the present invention. FIG. 6 is a schematic isometric view of an alternative implementation of a tissue disruption element that includes a plurality of rotating segments in each of a linear shape and an arcuate shape, in accordance with one embodiment of the present invention. FIG. 19 is a schematic isometric view of tissue that breaks down elements similar to those of FIG. 18B but utilizes segments mounted on a common flexible shaft, according to one embodiment of the present invention. FIG. 19B is a schematic and cross-sectional view illustrating the mounting of a segment on a common flexible shaft according to the principle of FIG. 19A. FIG. 19B is a schematic and cross-sectional view illustrating the mounting of a segment on a common flexible shaft according to the principle of FIG. 19A.

The following detailed description is the presently considered best mode of implementation of the present invention.
Since the scope of the present invention is well defined by the appended claims, this description should not be construed in a limiting sense, but merely for the purpose of illustrating the general principles of the invention. Has been created.

  The present invention generally provides a tissue disruption device that is used in preparation for inserting a transplanted tissue into a human or animal body, such as spinal surgery. The preferred embodiment is particularly configured for cutting and comminuting disc material during a discectomy or fusion procedure in the neck, chest and lumbar spine. The device may comprise an elongated tissue disrupting element that is rotatable and deflectable about its central axis, the central axis being a longitudinal axis when the tissue disrupting element is in a straight state. The tissue disruption element may be rotatably fixed in a distal position and may be deflectable to a curved shape. The rotational drive is configured to rotate the tissue disrupting element about its central axis in a straight state and in a curved shape. The elongate element may be wrapped tightly around the tissue disrupting element. In some embodiments, the elongate element protrudes sufficiently radially from the tissue disrupting element, and rotation of the tissue disrupting element results in axial movement of the disrupted tissue. In a preferred embodiment, the tissue disrupting element and / or the elongated element comprises a wire mesh. The tissue disruption device of the present invention can, for example, integrally include a support element (see FIG. 3A-3B). The device may be located, for example, in the vertebral body or in contact with the anterior portion of the disc from the side or by other means. The tissue disruption device is such that the length of the tissue disruption element of the device spans the length of the intervertebral disc and that the deflection of the tissue disruption element to a curved shape is a plane of deflection (eg, an axial plane of anatomical terms) Along the plane of fracture) and rearward along the plane of destruction.

  Use of the device of the present invention in any of the methods of the present invention may cut, pulverize, or otherwise disrupt soft or hard tissue in the human or animal body. The term “fracture” as used herein refers generically to any process that changes the state or properties of a tissue by the direct application of mechanical energy, including cutting, scratching, breaking, slicing, tearing, grinding, Including but not limited to powdering. The tissue disruption techniques, methods and devices of the present invention may be performed on healthy or diseased tissue, for example, hard tissue such as bone or soft tissue such as part of an intervertebral disc. Good.

In contrast to prior art tissue disruption devices and methods where the disruption element is rigid, the tissue disruption element of the tissue disruption device of the present invention may be flexible and deflectable into a curved shape. In contrast to prior art devices that do not rotate or bend or both, the tissue disrupting element of the device of the present invention may rotate on its central axis and deflect into a curved configuration. Furthermore, the tissue disrupting element of the device of the present invention may rotate and bend simultaneously. In contrast to prior art tissue disruption devices and methods in which elements on the shaft rotate on the longitudinal axis of the device, the tissue disruption element of the device of the present invention rotates on its central axis. In contrast to prior art tissue disruption devices having elements that are not rigidly attached to the shaft, the tissue disruption elements and assemblies of the present invention include an elongated element that is rigidly attached to the tissue disruption element, such as a flexible shaft. In further contrast to prior art tissue disruption devices, the device of the present invention may have two fixed endpoints for a tissue disruption element, which may be a flexible shaft. As a result, in contrast to certain prior art devices and methods that rotate about tissue disruption elements or their coils, the present devices and methods do not swing coils, elongated elements, or tissue disruption elements, and As a result of the fact that the elongate element is configured to be rigidly attached to a breaking element (eg, a flexible shaft) but prevents the tissue breaking element from deflecting, the tissue breaking device and method of the present invention is The space, amount and position of the tissue is controlled, and in a preferred embodiment these are strictly controlled. This can convince the user to remove all tissue in the space where the implant is placed or where the tissue is desired to be destroyed. Furthermore, as a result of this control, in contrast to prior art tissue disruption devices, the device and method of the present invention allows the user to destroy only the relevant space in which the implant is placed, not the entire disc. To. For example, the method and apparatus of the present invention may be used to leave the annulus in place. Furthermore, some of the nuclei may be left in place. This allows selective tissue displacement or destruction than is possible with prior art devices and methods. In contrast to the prior art, the user can create an implant enclosure, for example, by leaving an intervertebral disc that remains curved or arched in the outer region. This can help guide the insertion of the implant and in addition can minimize or prevent movement of the inserted implant. Furthermore, since the implant can rest on hard / cartilage that is not removed during fracture, the consequence of the substituting of the transplanted tissue in soft bone tissue can be avoided. Furthermore, in contrast to prior art methods and devices, the devices and methods of the present invention allow for short surgery with less surgical work as a result of its tight control and ability to leave disc residue in place. To. The medical merit of performing a short-time operation is well known, such as few traumas and quick recovery. The control and selection of the tissue to be destroyed as described above is, in one preferred embodiment, not freely rocked but by freely rotating and deflecting the tissue disrupting element (and assembly) about its central axis. In other preferred embodiments, it may be achieved, for example, by swinging freely from the deflection surface within a defined limit of, for example, up to 5 degrees, or up to 10 degrees, or up to 20 degrees or 30 degrees, for example. May be. Further, in contrast to another prior art device and method of tissue disruption, in the present invention, the disrupted tissue is tissue disrupted from the body, for example in certain preferred embodiments where the elongated element is helical. Can be automatically pulled out of the patient's body through the conduit as a direct automatic result of the rotation of the tissue disrupting element and the elongate element without the need for a separate element for removal. In contrast to prior art tissue disruption devices and methods, the tissue disruption device and method of the present invention is capable of vibrating a flexible shaft by rotation about its central axis and simultaneous deflection to a curved shape. Good. Also, in contrast to the prior art, in some embodiments, there is no or no deflection, and the tissue disrupting element may gradually bend into a curved shape range until it reaches a fully curved configuration. And this controls the amount and space of the destroyed tissue. In contrast to the prior art, the amount of radial movement of the tissue disruption element from the longitudinal axis L (see FIG. 1) during deflection or arcuate movement is, for example, the point of attachment of the tissue disruption element with the support element 40 It may be determined in advance based on the configuration. Further, in contrast to the prior art, the amount of tissue destroyed is at least partially relative to the tissue disruption element, the elongated element, the support element and / or the movable pivot, or between the movable pivot and the fixed pivot. It may be determined in advance depending on the configuration of various positions.
The amount of destructive tissue that is destroyed by the device 10 may be predetermined or controlled.
For example, it may be at least in part by the shape of the elongated element 30, by the diameter of the tissue disrupting element 20, by the length of the tissue disrupting element 20 between the movable pivot 44 and the fixed pivot 45 (in other words, the tissue disrupting element May be predetermined or controlled by the maximum movement of the arcuate motion when deflecting into a curved configuration (with the widest part of “D”). In contrast to the prior art, in the implementation method for soft tissue and hard tissue, the tissue disrupter may be the same, and the device and method for disrupting the tissue of the present invention is of the rotary drive (and thus of tissue disruption device 21). ) Controlling the number of revolutions and adjusting the density of the number of turns of the elongated element 30 to adapt to tissue destruction for different target tissue types, ie bone, soft tissue.

  The principles and operation of an apparatus and method for a deflectable tissue disruption device of the present invention can be better understood with reference to the drawings and accompanying descriptions.

  As shown in FIG. 1, the distal end 10 </ b> A of the tissue disruption device 10 may include a deflectable elongated tissue disruption element 20. As shown in FIG. 1, the tissue disruption element 20 may be rotatable about its central axis (the axis is labeled “C”). The central axis C may be parallel to the longitudinal axis L of the device 10, and in some cases may be collinear with the longitudinal axis L, particularly when the tissue disrupting element 20 is in a straight state. . On the other hand, as shown in FIGS. 2A-2B and 9B-10B, when the tissue disruption element 20 is in a curved configuration, its central axis C (see the dashed line in FIG. 2A) is curved, or the device It is not collinear or parallel to the ten longitudinal axes L. The term “distal portion” 10A of the tissue disruption device 10 includes the tissue disruption assembly 21 and at least the distal portion of the length of the assisting element 40, ie, from the distal end of the assisting element 40, of the movable pivot 44. Up to several points of the proximal support element. Thus, the tip 10A of the tissue disruption device 10 includes the most distal 10%, or in other preferred embodiments, for example, the most distal 20%, 30%, 40%, 50%, 60 of the device 10 %, 70%, 80%, or 90%.

  The tissue disruption element 20 is rotatably fixed in a distal position, i.e., fixed so that it can still rotate in a fixed state. The distal location may be the distal end of the device 10. The tissue disruption element 20 may be secured to a different part of the device 10 or to another device external to the device 10. The term “distal location” means a location that is distal by referring to the portion of the device 10 that is usually initially inserted into the patient and is usually controlled by the user. The “proximal” location usually means the location that will be inserted last into the patient. Thus, the distal portion of device 10 will typically be inserted into the patient first. In a preferred embodiment, the distal location is adjacent to the distal end of the tissue disruption element 20. In other preferred embodiments, the distal location may be more proximal if the deflection of the tissue disruption element is along only a portion of its length. In any case, in a preferred embodiment, the distal location is at or near the most distal portion of the tissue disruption element that deflects into a curved configuration. In other preferred embodiments, the distal position is at least as distal as the most distal portion of the tissue disruption element that deflects to its curved configuration.

  Although the rotary drive 98 is shown in FIGS. 3A-3B, it is understood that it is wide enough to include any mechanism for rotating the tissue disruption element 20. The rotational drive device 98 may include a rotational drive shaft and a motor as one preferred embodiment, and may be configured to rotate the tissue disruption element 20 about its central axis in a straight state and curved shape. Good. Therefore, the rotation drive device 98 may be configured to transmit a rotational force to the tissue destruction element 20 while giving a deflection operation of the tissue destruction element 20. The rotary drive is not a limitation or requirement, and in another embodiment, the rotary drive both deflects and rotates the tissue disrupting element 20, but typically the rotational drive deflects the tissue disrupting element 20 into its curved shape. Rather, it is typically an alternative mechanism that can include the deflection of the tissue disruption element 20 to its curved shape. In some preferred embodiments, as shown in FIGS. 3A-3B, the rotary drive 98 is located at the proximal end or at the proximal portion of the device 10.

  Most preferably, one or more motors may provide a driving force for driving the tissue disrupting element 20. The motor can be an electric, hydraulic or pneumatic drive with the electrical choice normally preferred for convenience reasons. For example, a configuration in which a manual rotational drive having a manual rotational power input handle is included in the scope of the present invention.

  As shown in FIGS. 3A-3B, the rotary drive device 98 may be located in the proximal portion of the device 10 and may remain outside the body of a human or animal subject during operation of the device 10. . The rotary drive device 98 may be exemplified by a motor. In this case, the output is transmitted along the elongate member by a rotational drive shaft that must be configured to transmit rotational force to the tissue disruption element 20. Alternatively, the present invention may employ one or more small motors that are deployed proximate to the tissue disrupting element 20, ie, near the distal end of the device 10. Suitable miniature motors are described in Dr. A number of sources such as the commercial SQUIGLGL motor (s) available from the product line "DC Micromotors" available from Fritz Faulhaber GmbH (Germany) and from the New Scale Technologies of Victor, NY (USA). Motor requirements can be readily selected by those skilled in the art according to the power, speed and maximum torque for each given application. In some cases, small motors may be connected in series to increase the total output power of the assembly. In its curved configuration as shown in FIGS. 2A-2B, 9A-9B, 10A-10B, the tissue disruption element 20 does not rotate about the longitudinal axis L of the device, but rather on its own central axis C. In order to ensure continuous rotation around, the tissue disruption element 20 may be connected to a rotary drive or other mechanism, for example, as such. The nature of the rotary drive 98 that ensures that the tissue disrupting element 20 rotates on its central axis, the connection to the rotary drive 98, or any other mechanism may be appropriate. For example, (i) the same or similar mechanism used to rotate the flexible shaft that connects the vehicle wheel to the vehicle tachometer, or (ii) cleans pipes and sewers It is a mechanism or similar mechanism used in the winding bend of piping to rotate the flexible shaft used for the purpose. In a preferred placement position, the longitudinal axis L of the device 10 is parallel to the delivery axis and the insertion direction of the device 10.

  As shown in FIGS. 2A-2B, 9A and 10 (a), in the curved configuration of the deflectable elongated tissue disrupting element 20, the tissue disrupting element 20 when combined with the longitudinal axis L of the device 10 is “D "Or substantially D-shaped. The curved configuration of tissue disruption element 20 may also comprise an arch shape. And thereafter it may continue to rotate on its central axis C. In a preferred embodiment, tissue disruption element 20 (and assembly 21) rotates on its central axis C during full deflection from a straight state to a curved configuration. In some other preferred embodiments, the tissue disruption element 20 has the last 90% of its deflection, the last two thirds, or the last half, the last third or the last quarter. Rotate on the central axis C only for a while.

  The rotation of the tissue disrupting element 20 on its central axis C while the tissue disrupting element 20 deflects into a curved configuration may cause the tissue disrupting element 20 to vibrate. The greater the vibration, the greater the further curvature and deflection to the tissue disruption element.

  In certain preferred embodiments, the tissue disruption element 20 may be deflectable into a curved configuration over its entire length. In other preferred embodiments, the tissue disruption element 20 is only a portion of its length, eg, 90%, 5/6, 5/4, 3/4, 2/3, half of its length. You may deflect | deviate to the curved structure along 1/3, 1/4, etc. Accordingly, the curved configuration of the tissue disrupting element 20 may extend from a distal location to a proximal location. The proximal position may be on the longitudinal axis L, but that is not a requirement. The curved configuration is 90% of the proximal position at the proximal half position of the tissue disruption element 20 (meaning the nearest half of the length), or the nearest 5/5, 4/5 At a position along the quarter, two-thirds, half, one-third, or in other preferred embodiments, such as one-fourth of the tissue disrupting element 20. As such, it may extend from a distal position to a proximal position. The curved configuration may extend from the entire distal position of the tissue disrupting element 20 to the proximal end (the end). The proximal end may be located on the longitudinal axis of the device.

  The tissue disruption element 20 may be deflectable in a number of ways in a curved configuration. In one preferred embodiment, the most preferred embodiment from FIGS. 1 and 2, the tissue disruption element 20 is deflectable by axially moving the movable pivot 44 of the support member 40 toward a distal position. is there. The movable pivot 44 may be located at the proximal end (i.e., the end) of the tissue disrupting element 20, or the proximal portion (the most proximal half, or one third, or 4 of the tissue disrupting element 20). It may be located at a position of 1/5, 5/6, or 7/10). The movable pivot 44 may be connected to the end of the tissue disrupting element 20. In other preferred embodiments, the tissue disruption element 20 may be deflected from its straight state to a curved configuration by an actuator element that does not have a movable pivot added to the fixed pivot. For example, each end of the tissue disruption element 20 may be connected to a movable pivot 44 that is actuated by an actuator element (not shown). The movable pivot 44 may be part of the support element 40. The actuator element that moves the movable pivot 44 may be any suitable element including a pressing element, a magnet, and the like.

  As shown in FIGS. 3A-3B, the assisting element 40 of the device 10 also includes a deflection handle 85 and a rotational drive 98 for deflecting and rotating the tissue disruption element 20 (and assembly 21), eg, proximal end. You may integrate and prepare. In operation, for example, in one preferred embodiment, a tissue opening extending approximately 40-60 millimeters is formed by the surgeon to provide a length of space for the tissue disruption element 20, and this length is not limited. In operation, rotation of the tissue disrupting element 20 may cause axial movement of the destroyed tissue and may cause the destroyed tissue to enter the or through the support element 40 of the subject / patient's body. It may be moved outside. Support element 40 may also function as a conduit for disrupted tissue. In certain preferred embodiments, the assisting element 40 is also as a conduit for a mobile fixation element, or as another device, the assisting element 40 is at the site where the device 10 is placed, eg, at or adjacent to the vertebral body, Or it may be used as a conduit for delivering a fixation element or other device to the side of the vertebral body.

  As shown in FIGS. 1A-1B and 2A-2B, the tissue disruption element 20 may be deflectable because it is a flexible shaft 20a (or a flexible cable). In that case, the device 10 may have an elongated element 30 that can be wrapped around the tissue disrupting element 20 and is rigidly attached to the tissue disrupting element 20. The elongated element 30 is rigid to the tissue disrupting element 20 at one, at least one, or at least two, preferably three or four (or more) along the tissue disrupting element 20. It may be attached. The tissue disrupting element 20 can be rigidly attached to the elongate element 30, but the tissue disrupting element 20 can nevertheless still be deflected (ie flexible) and away from the longitudinal axis L. It should be noted that it is flexible enough to be changed to its curved configuration.

  In a preferred embodiment, tissue disruption element 20 is deflectable as a result of being flexible (ie, embodiments other than FIGS. 19A-19C), but flexible shaft 20a (see FIG. 13) (and normal) The tissue disrupting element 20) may have a torsional stiffness, such as a torsional stiffness sufficient to support a flexible shaft 20a that rotates about its own central axis C, for example. The elongate element 30 may actually be able to be wrapped tightly around the flexible shaft 20a. The density of turns of the elongated element 30 around the tissue disrupting element 20 (ie, turns per inch) may vary depending on the embodiment and may be tailored to the target tissue. This may be used to tailor the device 10 and method to a specific target tissue (soft, hard, etc.) in addition to RPM to the rotary drive.

  In one preferred embodiment, the elongate element 30 may have a torsional stiffness equivalent to the tissue disruption element 20, and in other preferred embodiments, the elongate element 30 may be stiffer, and in either case However, the elongate element 30 may be less stiff than the tissue disrupting element 20 in other particular preferred embodiments.

  For convenience, the optional elongate element 30 and the tissue disruption element 20 are both referred to as a tissue disruption assembly 21 (FIG. 2A). Although the assembly 21 is described only in FIG. 2A, the elongate element 30 and the tissue disruption element 20 together constitute the assembly 21 of any embodiment in which the elongate element 30 is present. The assembly 21 may also have an optional clamp / crimp 29 that rides on the tissue disruption element 20. Thus, when the tissue disrupting element 20 is in a straight state, the tissue disrupting assembly 21 can be said to be in a straight state, and when the tissue disrupting element 20 is deflected into a curved configuration, it can deflect into a curved configuration. I can say that.

  As shown in FIGS. 1A-5 and 9A-10B, the elongate element 30 may wrap around the tissue disrupting element 20 in a helical fashion. The elongated element 30 may protrude sufficiently radially from the tissue disrupting element such that rotation of the tissue disrupting element 20 results in axial movement of the disrupted tissue.

  The elongate element 30 may have various shapes. For example, the elongated element 30 may have a cylindrical cross section, a square cross section, a triangular cross section, or other shapes. . Such a triangular shape in cross section may have two long sides, where the two long sides protrude outwardly from the flexible shaft along the radial length of the elongated element 30. To do. If the tissue disruption element has a rectangular cross-section, in certain preferred embodiments, the long side of the rectangle projects radially outward from the flexible shaft. As the radial length of the elongated element 30 from the flexible shaft 20a increases, the elongated element 30 may have a tapered thickness, for example, gradually.

As shown in FIGS. 1A-5 and 9B-10A and, for example, FIGS. 11 and 13, the elongate element 30 may have many cutting edges and blades due to its shape advantage, which is a first radial length. A first blade having a thickness and a second blade having a second radius length smaller than the first radius length may be included. Many blades have a blade with a first radial length in the middle region along the length of the rotating shaft;
Different radial length blades may be included that are arranged such that the distal and proximal regions with respect to the intermediate region have a second radial length blade that is less than the first radial length.

  The amount of radial movement of the tissue disrupting element 20 from the longitudinal axis L during deflection or arching is at least partially predetermined based on the configuration of the attachment point of the tissue disrupting element to the assisting element 40. can do. Also, the amount of tissue destroyed can be predetermined at least in part by the configuration of the tissue disruption element 20, the elongated element 30, and the support element 40. In some preferred embodiments, the amount of tissue destroyed is pre-determined, at least in part, by the configuration of the tissue disrupting element 20, the elongated element 30, and the relative position between the movable pivot 44 and the fixed pivot 45. Can be determined (see FIGS. 1 and 2).

  The amount of destructive tissue that is destroyed by the device 10 may be predetermined or controlled. For example, it can be determined, at least in part, by the shape of the elongated element 30, by the diameter of the tissue disrupting element 20, and by the length of the tissue disrupting element 20 between the movable pivot 44 and the fixed pivot 45 (ie, changing the tissue disrupting element). It may be predetermined or controlled by the length of the part) and / or by the maximum amount of arching movement (in the widest part of D) during deflection into a curved configuration.

  In the present invention, the deflection of the tissue disrupting element 20 may be induced by any suitable means that produces a continuous rotation along its central axis C. However, in addition to the fact of the deflection that the force on the movable pivot 44 towards the fixed pivot 45 of the support element 40 is induced by the induced force, for example, its orientation, nature and / or the deflection of the curved configuration. The shape may also be controlled. For example, in a preferred embodiment, the assisting element 40 is a blocking element 42 (eg, in an arcuate motion) that moves the tissue disruption element 20 to a curved configuration, eg, along a deflection plane perpendicular to the longitudinal direction of the device 10. 3A, 3B, 8A, 9B, 10A). The deflection surface may be an axial surface in anatomy in some preferred embodiments.

  As best seen in FIGS. 5 and 10A, blocking element 42 may be a beam having a C-shaped cross section. The C-shaped beam 42 may move the tissue disrupting element 20 laterally along a plane perpendicular to the longitudinal direction of the device 10 and parallel to the two sides of the C-shaped beam 42. In general, depending on the orientation of the device 10 of the present case, this plane perpendicular to the longitudinal direction of the device 10 is axial / horizontal in an anatomical sense, and in other preferred embodiments is perpendicular in the sense of anatomy ( A sagittal plane, a plane parallel to the sagittal plane, a front / coronal plane, or a plane parallel to the front / coronal plane). The C-shaped beam is open on one of its four sides so that it can be deflected from the open side (or, in various other preferred embodiments, it is fully open or its length Or a beam that is open along all of the length of the tissue disrupting element 20 or along almost all of the length of the tissue disrupting element 20. The blocking element 42 in the shape of a C-shaped beam 42 may be closed on at least a part of the other three sides. For example, as best shown in FIGS. 9B and 10A, a C-shaped beam may have sides that open to the side on which the deflecting tissue disrupting element 20 is deflected. The blocking element 42 may be integral with the remainder of the assisting element 40 (FIGS. 3A-3B) and may extend only along the distal portion of the device 10 where the tissue disrupting element 20 is disposed. As shown in FIG. 1A, the hill 43 or bump 43 of the tissue disruption sheet 400A, in any embodiment substantially along the plane of deflection from a straight state to a curved configuration, as shown in FIG. Other elements that may be used to assist in the operation of tissue disruption element 20 (and assembly 21). It is noted that this deflection typically occurs when the element 20 is simultaneously rotating about its central axis C.

  In a preferred embodiment, as can be seen from FIGS. 2A-2B, the deflection of the tissue disrupting element 20 occurs when the movable pivot 44 of the assisting element 40 moves. For example, deflection of the tissue disrupting element 20 may occur when the movable pivot 44 moves linearly, for example, along the direction of insertion of the device 10 into the living body, and is movable as shown in FIGS. 3A-10B. This may occur when the pivot moves into a C-shaped beam 42 having a blocking element 42. The support element 40 may be attached to the tissue disruption element 20 at a movable pivot 44 as shown in FIGS. 2A-2B, 9B, 10A or may be attached at one or more fixed pivots 45. Good.

  As can be seen in FIGS. 1A, 2A, 9B, 10A, the pushing portion 400 (having a shaft) of the assisting element 40 moves a movable pivot 44 to which the proximal end of the tissue disrupting element 20 may be connected. As a result, it induces bending of the tissue disrupting element 20 (and assembly 21). Although the movable pivot 44 is not shown in FIG. 4, this figure shows the extruded portion 400 not specifically written in FIG. 5. The tissue disrupting element 20 may be mechanically connected by a universal joint to a shaft that is located in the extrusion 400 and may receive rotational drive from the rotational drive 98. The movable pivot 44 may be located at or within the universal joint to maintain rotation and further deflect at the movable pivot 44. The rotational drive shaft of the extrusion 400 may also be a flexible rotational drive shaft that extends beyond the movable pivot 44 as the tissue disruption element 20 in the form of a flexible shaft 20a.

  As shown in FIG. 5, certain portions of the length of the assisting element 40, eg, the blocking element 42, are not continuous in some preferred embodiments necessary to accommodate the wide tissue disruption assembly 21. Or it may have an open wall, which may be wide because the elongated element 30 is wide.

  As shown in FIGS. 3A-3B, the pusher 400 may be actuated by a deflection handle 85 located at the proximal end of the device 10, for example. For example, the throttling handle may guide advancement toward the fixed pivot 45 to the movable pivot 44 and may guide deflection of the tissue disruption element 20 (and assembly 21) to a curved configuration. This may occur, for example, by means of a shaft (not visible) in the pusher 400 that operatively engages the movable pivot 44 with the rotary drive 98. Release handle 85 returns tissue breaking element 20 (and assembly 21) to a straight state. The mechanism for inducing the deflection of the tissue disrupting element 20 (and assembly 21) is not a required or restricted feature, and other suitable mechanisms may be employed. In the preferred embodiment, strict control is achieved with only two degrees of freedom for the tissue disrupting element 20, rotation about or about the central axis, and in or substantially in the deflection plane perpendicular to the bottom surface 48 of the embodiment device 10. In particular, the position and amount of the destroyed tissue are controlled by allowing deflection within the deflection plane (plus mainau 5 degrees). These degrees of freedom of movement are depicted by arrows in FIG. 1B. The fixed pivot structure 45B around the fixed pivot 45 including the peripheral side wall 46 has one way of accomplishing this, as shown in FIGS. 1A-1B. A restrictive fixed pivot structure 45B having a side wall 46 is not shown in certain other views, such as FIGS. 9A and 10B, but these other views are shown in FIGS. 1A-1B. It can be seen that it is suitable to show an embodiment of the pivot structure 45B. Thus, the lower arrow in FIG. 1B indicates rotation around the central axis C, while the upper arrow is marked D because rotation around the axis D allows deflection to a curved configuration. Shown is rotation by a “fixed” joint 45 (or called a fixed pivot 45) about a remote vertical axis. The fixed joint 45 or the fixed pivot 45 is called “fixed” because it does not move linearly along the longitudinal axis L (or the central axis C) like the movable pivot 44 (see FIGS. 2A and 2B). I understand that.

  In certain other preferred embodiments, strict control over the location and amount of tissue destroyed by strict control over the operation of the tissue disruption element 20 (or assembly 21) is typically maintained, but such strict control. A third degree of freedom is introduced to loosen or at least allow a predetermined large movement of the tissue disrupting element 20. In these embodiments, the tissue disruption element 20 is rotated about the central axis, deflectable to a curved configuration, and the polarization plane when the tissue disruption element is in a curved configuration (eg, the bottom surface of a flat device). 3 degrees of freedom including a swing from one plane to the other side of the plane of polarization. The peristalsis is depicted in FIG. 2B, including the arrows in the figure. Although FIG. 2B shows a peristaltic movement of one of the deflection surfaces, such a perturbation may also occur on the other side of the polarization plane. The peristalsis may be due to rotation and deflection of the tissue disrupting element 20 and / or any accompanying vibration. In the preferred embodiment, due to the blocking element 42, the peristalsis is limited to 5 degrees, in other preferred embodiments to 10 degrees, and in still other preferred embodiments to 15 degrees, 25 degrees, and 30 degrees. The In a preferred embodiment, the amount of rocking from the deflecting surface includes one or more fixed pivot 45 and movable pivot 44 structures, a tissue disrupting element 20 structure (ie, thickness or diameter), and a blocking element 42 structure. May be determined in advance. In a preferred embodiment, the tissue disruption assembly 21 swings as a unit from the deflection surface. It will be understood that the deflection surface referred to is determined as a plane perpendicular to the flat surface on which the device 10 rests or a plane perpendicular to the bottom surface of the device 10 which appears to be flat. As shown in FIGS. 2A-2B, the device 10 may include a fixed pivot structure 45A that may be constructed without complete sidewalls, thus side the fixed pivot 45 that may be within the fixed pivot structure 45A. Can be moved towards. In contrast, as shown in FIGS. 1A-1B, lateral movement of the fixed pivot boule 45 with the tissue disruption element 20 attached is limited by a fixed pivot structure 45B having a complete or sufficiently complete sidewall 46. May be. The curved configuration shown in FIGS. 2A-2B may be inferred to the embodiment shown in FIGS. 1A-1B, and similarly, the straight configuration shown in FIGS. 1A-1B is shown in FIGS. 2A-2B. It should be understood that the embodiments may be inferred.

  In any suitable embodiment, as shown, for example, in FIGS. 2A-2B, 9A-9B, and 10A-10B, the tissue disruption assembly 21 is one or more ends of the tissue disruption element 20, for example in a ring shape. In order to maintain an elongate element 30 located at and attached to the tissue disrupting element 20, a fastener or crimp 29 may be included. This fastener / waveform 29 is completely optional, and many preferred embodiments may not have this element.

As shown in FIG. 11, in a preferred embodiment, one or more elements of tissue disruption element 20 and elongate element 30 may comprise a wire mesh and may be formed of a wire mesh. .
The wire mesh may be a mesh in which thin wires are knitted.
In the preferred embodiment shown in FIGS. 11 and 12, each meshed wire may be helical.

For example, the outer surface 27 of the tissue disrupting element 20 may include a wire mesh 92 or may be formed from the wire mesh 92.
Further, as will be described below, the elongate element 30 may itself include a wire 91 of wire mesh 92 or may be formed of wire 91.

In the preferred embodiment of the tissue disruption assembly 21 as shown in FIG. 11, the wire mesh 92 may be such that the wires 91 of the wire mesh 92 support each other geometrically without being attached to a rigid shaft. Good.
In another preferred embodiment, as shown in FIG.
The size may be adapted to a flexible shaft 20 a having a tissue disrupting element 20.

  The wires 91 of the wire mesh 92 are spirally wound around the central axis of the device 10, and the wires 91 support each other without being firmly bonded to each other. As shown in FIG. 11, one (or more) specific wires 91a of the wires 91 of the wire mesh 92 project, for example, radially beyond the outer surface to form a cutting edge for breaking tissue. By having, it may have a strange shape with respect to other wires. As a result, as shown in FIG. 11, the elongated element 30 of the tissue disruption assembly 21 may have one particular wire 91a that may be helical. Of course, in other preferred embodiments, the particular wire 91a is not limited to a single protruding wire, but may have a plurality of protruding wires. Two opposing wires having the same or different geometric cross-sections may be assembled to form a tissue disrupting element 20 or assembly 21, which may resemble a DNA helical structure, for example 12 is a side view of a representative portion (part) of the wire mesh 92 shown in FIG.

  In a preferred embodiment, one of the particular wires 91a may be helical, may have a triangular cross section, and may have a cross section of other shapes (such as a rectangle). Such a triangular cross-section may have two long sides, which may protrude outwardly from the flexible shaft along the radial length of the elongated element 30. A particular wire or wire 91a may have a thickness that, for example, gradually tapers as the radial length of the elongated element 30 from the flexible shaft 20a increases.

  The wire mesh 92 may be attached to the flexible shaft 20a. For example, as shown in FIG. 13, the tissue disruption element 20 may have a cylindrical surface 20a and the wire mesh may wrap all or at least part of the length of the cylindrical surface 20a. As shown in FIG. 13, at least one end 92 a (preferably both ends) of the wire mesh 92 (or the wire of the wire mesh 92) is in the axial direction of the wire of the wire mesh 92 during rotation of the tissue disruption assembly 21. It may be connected to the cylindrical surface 20a to prevent translation (along the shaft 20a). As a result, in the preferred embodiment, each time the shaft 20a flexes and deflects, the wire mesh 92 tunes and flexes equally or equally.

  The preferred embodiment shown in FIG. 14 depicts a wire mesh 92 that is stiff enough to form the tissue disruption element 20 without conforming to a separate flexible shaft 20a. Nevertheless, the wire mesh 92 may have sufficient flexibility to bend or deflect into the curved configuration of the tissue disrupting element 20 when actuated.

  As shown in FIG. 14, the odd shaped wire 91a of the wire mesh 92 is cup-shaped, i.e., so that the device 10 or tissue disruption assembly 21 draws the destroyed tissue into the wire mesh 92. You may make the shape bent in the direction. For example, the wire 91a may have a U-shaped cross section.

  As mentioned above, the tissue disruption element 20 may be deflectable because it is a flexible shaft 20a (or a flexible cable). In certain preferred embodiments, the tissue disruption element 20 may, or alternatively, have other structures, such as a segmented tissue disruption element 20, as shown in FIGS. 18A, 18B, 19A, 19B, and 19C. It may be deflectable depending on the characteristic. In particular, the split embodiment of FIGS. 18A, 18B may be incorporated into any suitable embodiment described or depicted in this patent application, and FIGS. 18A, 18B are illustrated by a flexible drive connection 166. FIG. 3 depicts a tissue disruption element 20 having a rotating shaft 146 divided into three interconnected portions 146A-146C. The end of the distal portion 146c may be rotatably secured to the hinge 68 while further freely rotating about its longitudinal axis. Similarly, the proximal end of the proximal portion 146a may be rotatably fixed by a pin-in-slot 70 while freely rotating about its longitudinal axis. When the rotary pusher 400, which is or has a drive shaft, is forward, the placement pin 70 may cause the tissue disruption element 20 to transition from the state of FIG. 18A to the state of FIG. And sweeping a certain amount of tissue through the D shape. 19A-19C further illustrate an embodiment similar to FIGS. 18A-18B, except that the segments are all mounted on a typical flexible shaft 72. FIG. Where the tissue disruption element 20 is split, as shown in FIGS. 18A-19C, the individual elongated elements 30 depicted here (not shown in FIGS. 18A-19C) may be May be wrapped around each individual segment (eg, 146a-146c).

  As shown in FIG. 15, the present invention may be depicted as a method 100 for destroying target tissue of a human or animal body. The method 100 may include a step 110 of rotationally securing the deflectable and elongated tissue disrupting element 20 to the assisting element 40 in a distal position, the tissue disrupting element 20 being rotatable about its central axis. The central axis is the longitudinal axis when the tissue disrupting element 20 is in a straight state. The structural elements mentioned in step 110 may be consistent with any device embodiment depicted herein. The method 100 may include a method 120 for inserting the deflectable elongated tissue disrupting element 20 and the assisting element 40 into a patient or subject. A further step 130 of the method 100 may deflect the tissue disrupting element into a curved configuration while rotating the tissue disrupting element about its central axis to destroy the target tissue.

  The method 100 may include rotating the tissue disruption element at multiple arch positions. In some versions, the method 100 may include inserting a hard conduit into the body adjacent to the target tissue and inserting a tissue disruption device through the hard conduit. There may be steps of the method 100 having using the assisting element to move the tissue disrupting element in an arcuate motion while the tissue disrupting element is rotating.

  Some versions of the method 100 include moving a movable pivot attached to the tissue disruption element in an axial direction. The method 100 may also include using a blocking element that deflects the tissue disrupting element into a curved configuration in a direction along a plane perpendicular to the longitudinal direction of the device. The blocking element may have a C-shaped cross section for moving the tissue disrupting element. The steps of method 100 may rotate the tissue disruption element in the proximal position such that the curved configuration of the tissue disruption element extends from the distal position to the proximal position. The steps of method 100 may use a C-shaped assist element to guide the arcuate motion in the forward direction.

  The method 100 may include using an elongate element, e.g., a helically wound elongate element 30, to pull the destroyed tissue back through the conduit through which the tissue disrupting element 20 was delivered. The method 100 may use, for example, an Archimedean screw as shown in FIG. An elongate element wound tightly around the tissue disrupting element may be used as a cutting blade to disrupt the target tissue, which may be pulled back through, for example, a conduit.

  In some versions of the method 100, a step may configure the tissue disruption element to have a wire mesh that supports the wires without being firmly connected to each other. Any detailed structure depicted with respect to device 10 may be used in implementation method 100 having a detailed structure including wire 91 of wire mesh 92.

  As shown in FIG. 16, the present invention may also be described as a method 200 for disrupting intervertebral disc tissue of a human or animal body. The method 200 includes a step 210 of inserting a deflectable and elongated tissue disrupting element into the human or animal body, for example as part of the tissue disrupting device 10, the tissue disrupting element being rotatable about its central axis. And its central axis is the longitudinal axis when the tissue disrupting element is in a straight state, and the tissue disrupting element is mounted in a distal position. The structural elements described in step 210 may be consistent with any of the apparatus embodiments described herein. The inserted tissue disruption element may be inserted laterally and may be positioned across the vertebral body as shown in FIGS. 6-9B. For example, the tissue disruption element of the tissue disruption device 10 may be inserted into the anterior portion of the vertebral body, or deflected posteriorly, for example, to disrupt tissue that is the target tissue in the nucleus of the vertebral body. .

  The method 200 also allows the tissue disruption element to rotate about its central axis to disrupt an amount of tissue in the space occupied by the disc while leaving at least the arcuate portion of the disc tissue (ie, intact). And a step 220 for deflecting the tissue disrupting element to a curved configuration while attached to the distal portion. Method 200 may leave (ie, leave) the arcuate portion (ie, as it is) of the tissue so that at least the arcuate portion (ie, as it is) of the tissue lies on a plane with the disc. For example, step 220 of method 200 may include, in a preferred embodiment, a portion of the vertebral body nucleus in addition to all of the annulus of the vertebral body (5% or 10% in various variable preferred embodiments or 20% or 30% or 40% or 50% or 2/3 or 4/5 or 90%) may be left (ie, as is). Certain steps of the method 100 leave at least an arcuate portion in the human or animal body so that at least the arcuate portion separates the transplanted tissue from the spinal canal tissue (or spinal cord tissue in other preferred embodiments) (ie. Step).

  A further step 230 of the method 200 may be implanting the implant so that the implant is surrounded by at least the arcuate portion (ie, intact) of the disc tissue.

  As shown in FIG. 17, the present invention may be further described as a method 300 for disrupting intervertebral disc tissue of a human or animal body. The method 300 may include a step 310 of inserting a deflectable, elongated, tissue disrupting element rotatable about its central axis into a human or animal body, the central axis being in a state where the tissue disrupting element is straight. The longitudinal axis and the tissue disrupting element is mounted in a distal position, the tissue disrupting element having an elongate element that is rigidly and spirally wound around the flexible shaft. The structural elements depicted in step 310 may be identical to any device embodiment depicted herein.

  Another step 320 of the method 300 may predetermine the amount and location of tissue to be destroyed by configuring a support element attached to the tissue disrupting element. The method 300 is curved while the tissue disruption element is rotating to destroy an amount of tissue in the space occupied by the intervertebral disc, or leaving at least (ie, as is) the tissue of the arcuate portion of the intervertebral disc. There may be a step 330 of deflecting the tissue disrupting element into the configuration.

  Some versions of the method 300 may include configuring the support element by setting the relative position of a movable pivot and a fixed pivot attached to the tissue disruption element. Other versions of the method 300 may include configuring the support element by setting the position of two or more movable pivots attached to the tissue disruption element.

  The method 300 further pre-determines the amount and location of tissue to be destroyed by setting the diameter of the tissue disrupting element and setting the shape of the elongated element that is wound and tightly attached around the tissue disrupting element. You may have. Another version of the method 300 pre-determines the amount and location of tissue to be destroyed by setting the diameter of the tissue disrupting element and setting the shape of the elongated element that is wound around and rigidly attached to the tissue disrupting element. You may have the process to determine. Some versions of the method 300 include tissue between the movable pivot 44 and the fixed pivot 45 (ie, depending on the length of the deflecting portion of the tissue disruption element), depending on the shape of the elongated element 30, the diameter of the tissue disruption element 20, and the like. Tissue destroyed by the device 10 at least in part by the length of the breaking element 20 and / or by maximum movement of the arcuate motion (in the widest part of “D”) during deflection to a curved configuration You may have the process of controlling the amount of destruction and determining beforehand.

  It should be understood that one or more steps of the methods 100, 200, 300 depicted herein may be combined. Further, any suitable embodiment of the apparatus 10 depicted herein that is consistent with particular method steps may be used in any method 100, 200, 300.

  The “rotation” of the tissue disruption element about the central axis can be clockwise rotation, counterclockwise rotation, and reciprocating rotational movement (ie, rotating in the opposite direction (ie, clockwise and Should be understood broadly to include (counterclockwise).

  For example, a 10% deviation from a magnitude of 10 means between 9 and 11.

  It should be understood that cables may be used where the shaft 20 is used as the tissue disruption element 20 in accordance with the present invention. Cable is understood to mean other flexible tension members or ropes made of twisted strands, for example wires.

  Although the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other uses of the invention may be made. Accordingly, the claimed invention described in the following claims is not limited to the embodiments described in the present specification.

Claims (59)

An elongate tissue disruption element that is rotatable and deflectable about a central axis, wherein the central axis is a longitudinal axis when the disruption element is straight and the tissue disruption element is rotatable at a distal position A tissue disruption element that is fixed to and deflectable to a curved configuration;
A rotation drive configured to rotate the tissue disruption element about a central axis in a straight state and a curved configuration;
A tissue disruption device comprising:
The tissue disrupting element is deflectable into a curved configuration by axially moving a movable pivot toward a distal position, the movable pivot defining a proximal end of the curved configuration of the tissue disrupting element The tissue destruction apparatus characterized by doing.   The tissue disruption device of claim 1, wherein a curved configuration of the deflectable elongated tissue disruption element when coupled to a longitudinal axis of the tissue disruption device forms a “D” shape.   2. The tissue disruption device according to claim 1, wherein the curved configuration has an arch shape.   The tissue disruption device of claim 1, wherein the curved configuration extends from a distal position to a proximal position, the proximal position being on a longitudinal axis of the tissue disruption device.   The tissue disruption device of claim 1, wherein the curved configuration extends from a distal position to a proximal position, the proximal position being located on a proximal half of the tissue disruption element.   The tissue disruption device of claim 1, wherein the curved configuration extends from a distal location to a proximal end of the tissue disruption element.   The tissue disruption device of claim 6, wherein the proximal end is on a longitudinal axis of the tissue disruption device.   The tissue disruption device of claim 1, wherein the distal location is a distal end of an assisting element of the tissue disruption device.   The tissue disruption device of claim 8, wherein the movable pivot is located at a proximal end of the tissue disruption element.   The tissue disruption of claim 1, further comprising a conduit through which the tissue disruption device is deployed, wherein axial movement of the disrupted tissue moves the disrupted tissue through the conduit. apparatus.   The tissue disruption device of claim 1, further comprising an elongated element wound and rigidly attached about the tissue disruption element, wherein the tissue disruption element is a flexible shaft.   The tissue disruption device of claim 11, wherein the elongated element is wound around the tissue disruption element.   The tissue disruption device of claim 12, wherein the elongate element is helically wound around the tissue disruption element.   The elongate element is rigidly attached around the tissue disrupting element and sufficiently protrudes radially from the tissue disrupting element so that rotation of the tissue disrupting element causes an axial movement of the disrupted tissue; The tissue disruption device according to claim 13, wherein   12. The tissue disruption device of claim 11, wherein the elongated element has a cylindrical cross section.   12. The tissue disruption device of claim 11, wherein the elongated element has a square cross section.   12. The tissue disruption device of claim 11, wherein the elongated element has a triangular cross section.   18. The triangular shape has two long sides, the two long sides projecting outward from the flexible shaft along a radial length of the elongated element. The tissue destruction apparatus described.   12. The tissue disruption device according to claim 11, wherein the elongated element has a rectangular cross section, and the long side of the rectangle protrudes radially outward from the flexible shaft.   The tissue disruption device of claim 11, wherein the elongated element has a thickness that tapers as the radial length from the flexible shaft increases.   The tissue disruption device of claim 11, wherein rotation of the tissue disruption element causes vibration of the flexible shaft when the tissue disruption element deflects into a curved configuration.   12. The tissue disruption device of claim 11, wherein the elongate element is tightly wound around the flexible shaft.   The configuration of the point of attachment of the tissue disrupting element to the assisting element at least partially pre-determines the amount of radial movement of the tissue disrupting element from the longitudinal axis during arching. 11. The tissue disruption device according to 11.   12. The tissue disruption device of claim 11, wherein the amount of tissue destroyed is pre-determined at least in part by the configuration of the tissue disruption element, the elongate element, and the support element.   The amount of tissue destroyed is pre-determined, at least in part, by the configuration of the tissue disruption element, the elongate element and the relative position between the movable and fixed pivots. 11. The tissue disruption device according to 11.   The amount of tissue destroyed is at least partially between the deflection of the curved configuration by the elongated element shape, by the diameter of the tissue breaking element, by the length of the tissue breaking element between the movable pivot and the fixed pivot. The tissue destruction apparatus according to claim 11, wherein the tissue destruction apparatus is predetermined according to a maximum movement amount of the arch motion.   The tissue disruption device according to claim 1, further comprising a blocking element that moves the tissue disruption element in a direction along a plane perpendicular to a longitudinal direction of the tissue disruption device by arching.   28. The tissue disruption device of claim 27, wherein the blocking element is a C-type beam that moves the tissue disruption element laterally along the surface.   29. The tissue disruption device of claim 28, wherein a movable pivot moves within the C-shaped beam having the blocking element.   30. The tissue disruption device of claim 29, wherein a support element is attached to the tissue disruption element with the movable pivot and one or more fixed pivots.   The tissue destruction device according to claim 1, wherein an outer surface of the tissue destruction element is formed of a wire mesh.   32. The tissue disruption device of claim 31, further comprising an elongate element wrapped around and rigidly attached about the tissue disruption element, wherein the elongate element is formed of a wire mesh.   32. The tissue disruption device according to claim 31, wherein the wires are spirally wound around a central axis of the tissue disruption device, and the wires support each other without being firmly bonded to each other.   32. The tissue disruption device of claim 31, wherein one of the helical wires has a surface that projects radially beyond the outer surface and forms a cutting edge for disrupting the tissue.   34. The tissue disruption device of claim 33, wherein one of the spiral wires has a triangular cross section.   32. The tissue disruption device of claim 31, wherein the tissue disruption element has a cylindrical surface and the wire mesh surrounds at least a portion of the length of the cylindrical surface.   37. The tissue disruption device of claim 36, wherein at least one end of the wire mesh is connected to the cylindrical surface to prevent axial movement of the wire during rotation.   The tissue disruption device of claim 1, wherein the tissue disruption element has only two degrees of freedom: rotation about a central axis and deflection to a curved configuration. When the tissue disrupting element has a curved configuration, rotation about a central axis, deflection to the curved configuration, and swaying from the deflecting surface to either side of the deflecting surface; The tissue disruption device according to claim 1, having three degrees of freedom.   2. The tissue disruption device according to claim 1, wherein the tissue disruption element is divided. A method of destroying a target tissue in a human or animal body, the method comprising:
A step of rotatably attaching an elongated tissue disrupting element deflectable at a distal position to a support element, wherein the tissue disrupting element is rotatable about its central axis and when the tissue disrupting element is in a straight state The central axis is a longitudinal axis;
Inserting the deflectable elongated tissue disrupting element and the support element into the body; and
Deflecting the tissue disrupting element to a curved configuration as the tissue disrupting element rotates about a central axis to destroy target tissue.    42. The method of claim 41, wherein the tissue disruption element rotates at multiple arch positions.   42. The method of claim 41, further comprising inserting a hard conduit into the body adjacent to the target tissue and inserting the tissue disruption device through the hard conduit.   42. The method of claim 41, further comprising using a support element to move the tissue disrupting element in an arcuate motion while the tissue disrupting element is rotating.   42. The method of claim 41, further comprising the step of axially moving a movable pivot attached to the tissue disrupting element.   42. The tissue disruption method of claim 41, further comprising using a blocking element that deflects the tissue disruption element into a curved configuration in a direction along a plane perpendicular to the longitudinal direction of the tissue disruption device.   48. The method of claim 46, further comprising using a blocking element having a C-shaped cross section to move the tissue disrupting element.   42. The method of claim 41, further comprising rotating the tissue disruption element in a proximal position such that a curved configuration of the tissue disruption element extends from a distal position to a proximal position.   42. The method of claim 41, further comprising using a C-shaped support element to direct the arcuate motion in the forward direction.   42. The method of claim 41, further comprising using a helically wound elongate element to pull back the destroyed tissue through a conduit through which the tissue disrupting element is delivered.   42. The method of claim 41, further comprising using an elongated element wound tightly around the tissue disrupting element as a cutting blade to disrupt the target tissue.   42. The method of claim 41, further comprising configuring the tissue disruption element to have a wire mesh so that the wires support each other without being firmly connected to each other. A method of destroying intervertebral disc tissue of a human or animal body, the method comprising the following steps.
(A) inserting a deflectable and elongated tissue disrupting element into a human or animal body, the tissue disrupting element being rotatable about its central axis, the central axis being straight with the tissue disrupting element A longitudinal axis when in the state and the tissue disrupting element is attached in a distal position;
(B) the tissue disruption element is rotated about its central axis and attached to the distal portion to destroy an amount of tissue in the space occupied by the disc, leaving at least an arcuate portion of the disc tissue; Deflecting the tissue disrupting element into a curved configuration while
(C) inserting the graft so that the graft is adjacent to at least the arcuate portion of the disc tissue;   54. The method of claim 53, further comprising leaving the arcuate portion of tissue such that at least the arcuate portion of tissue is located on a plane with an intervertebral disc.   54. The method of claim 53, further comprising leaving at least an arcuate portion of the tissue in a human or animal body such that at least the arcuate portion of the tissue separates the transplanted tissue from the spinal canal tissue. A method of destroying intervertebral disc tissue of a human or animal body, the method comprising the following steps.
(A) inserting into the human or animal body a deflectable and elongated tissue disrupting element that is rotatable about a central axis, the central axis being a longitudinal axis when the tissue disrupting element is straight The tissue disrupting element is attached to a distal location, the tissue disrupting element having an elongated element that is tightly wound in a spiral,
(B) predetermining the amount and location of tissue to be destroyed by configuring a support element attached to the tissue destruction element;
(C) while the tissue disruption element is rotated about its central axis, the tissue disruption element is Deflecting to a curved configuration;   57. The method of claim 56, further comprising configuring the support element by setting a relative position of a movable pivot and a fixed pivot attached to the tissue disruption element.   Further comprising predetermining the amount and location of tissue to be destroyed by setting the diameter of the tissue disrupting element and setting the shape of the elongated element tightly wound and tightly attached around the tissue disrupting element 57. A method according to claim 56.   The tissue disruption device of claim 8, wherein a distal end of the tissue disruption device is attached to a distal end of the assisting element.