Tissue modification devices.

The reference patent is granted based on articles 1^or, 2 "fraction V, 6^or fra & ióft W, and 59 of the Industrial Property Law.

In accordance with article 23 of the Industrial Property Law, this patent is valid for twenty years, non-extendable, counted from the filing date of the international application and will be subject to the payment of so much to keep the rights in force.

Whoever signs this title does so based on the provisions of articles 6 ° fractions III and 7 bis 2 of the Industrial Property Law (Official Gazette of the Federation (DOF) 06/27/1991, amended on 08/02 / 1994, 10/25/1996, 12/26/1997, 05/17/1999, 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01/2010 , 06/18/2010, 06/28/2010, 01/07/2012 and 04/09/2012); items 1 ° 3^or fraction V part a), 4^or and 12^or Sections I and III of the Regulations of the Mexican Institute of Industrial Property (DOF 12/14/1999, formed on 07/01/2002, 07/15/2004, 07/28/2004 and 09/07/2007); items 1^or, 3^or. 4^or. 5^or fraction V subsection a), ..IMcaccionMI> and * JII and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended 10/10/2002, 07/29/2004, 04/08 / 2004 and 09/13/2007), 1, 3^or and 5 “Subsection a) cM Agreement that delegates powers to the Deputy General Directors, Coordinator, Divisional Directors, Heads of Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property (DOF: 12/15 / 1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

This document is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Payment and Electronic Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

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NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tax | 1695 || MX / 2017/51910 | MX / a / 2011/000510 | PCT patent title | 1027 | RGZ | Page (s)

2 | IMzoUeaMsBJUXAbqd9gKGZbK / SI =

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YCwlumxHhNSe5qlbVF8ONc1 AZ0j7qE0ilGewDGNIM9rFubCGFs3l5MwM9hltD3HyA9Caznyg == * Additional information on the back

Annual No. 550 Floor 1, Pueblo Santa María Tepepan. Xochimilco, 16020.

Mexico City (55) 53340700 www.gob mx / impi

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MODIFICATION DEVICE

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FIELD OF THE INVENTION ----------------—

The present invention is generally concerned with medical / surgical methods and devices. More specifically, the present invention is concerned with flexible tissue modifying devices and methods for modifying tissues using such devices, particularly for treatment of spinal stenosis.

BACKGROUND OF THE INVENTION

A significant number of surgical procedures involve modifying tissues in the body of a patient, such as by removing, cutting, shaving, abrasion, shrinking, ablation, or otherwise modifying the tissue. Minimally invasive (or less invasive) surgical procedures often involve tissue modification through one or more small incisions or percutaneous access and thus can be more technically challenging procedures. Some of the challenges of minimally invasive tissue modification procedures involve working in a smaller operating field, working with smaller devices, and trying to operate with reduced or even non-direct visualization of the tissue (or tissues) being modified. For example, using arthroscopic surgical techniques to repair joints

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Τ λ Τ 'τ I ί -λ τ χ i',_ν,,:, v¡ „.¡can US LA r« INDUSTRIAL OLD, such as the knee or shoulder, can be quite challenging to modify certain tissues to obtain a desired result, due to the required small size of arthroscopic instruments, the space surgical confined joint, lack of direct visualization of the surgical space and the like. It can be particularly challenging in some surgical procedures, for example cutting or contouring bone or ligamentous tissue with minimally invasive tools and techniques currently available. For example, attempting to shave a thin slice of bone from a curved bone surface, using a small diameter tool in a confined space with little or no ability to observe the surface that is cut, may be required in some procedures, it may be incredibly challenging or even impossible using currently available devices.

One area of ​​surgery that would likely benefit from the development of less invasive techniques is the treatment of spinal stenosis. Spinal stenosis occurs when the nerve tissue and / or the blood vessels supplying the nerve tissue to the spine are impacted by one or more structures that press against them, causing symptoms. The most common form of spinal stenosis occurs in the lower (or lumbar) spine and can lead to severe pain, numbness, and / or loss of function in the lower back and / or one or both.

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ΡΕ ΙΑ CHOZPAD INDUSTRY1 lower extremities.

Figure 1 is a top view of a vertebra with the cauda equina (the bundle of nerves extending from the base of the spinal cord) shown in cross section and two nerve roots branching out of the cauda equina to exit the canal spinal cord and extend through the intervertebral foramina either on one side or the other of the vertebra. Spinal stenosis can occur when the spinal cord, cauda equina, and / or nerve root (s) are impacted by one or more tissues in the spine, such as a changed or thickened ligamentum flavum, hypertrophied facet joint (such as superior articular processes). in Figure 1), osteophytes (or bone spurs) on the vertebrae, spondylolisthesis (slipping of one vertebra relative to an adjacent vertebra), facet joint synovial cysts and / or collapse, bulging or warming of an intervertebral disc. The impact of the neural and / or neurovascular tissue on the spine by one or more of these tissues can cause pain, numbness and / or loss of resistance or mobility in one or both of the patient's lower extremities and / or the patient's back. .

In the United States of America, spinal stenosis occurs with an incidence of 4% to 6% (or more) in adults 50 years of age and older and is the most frequent reason cited for back surgery in patients with age

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60 years and older. Patients suffering from spinal cord are commonly treated first —CUTI-prescription-conservative such as exercise therapy, pain relievers, anti-inflammatory medications, and injections of epidural spheres. When these conservative treatment options fail and symptoms are severe, as is often the case, surgery may be required to remove the impacted tissue and decompress the impacted nerve tissue.

IT. i dG 33 ^ 3 ^^ 3 ^ 3 1131 ^ 133 ^ i-VO¹"—Rn first make an incision in the back and spread the muscles and supporting structure away from the spine to expose the posterior aspect of the spine. The thickened ligamentum flavum is then exposed by removing complete or partial removal of the bony arch (lamina) covering the posterior part of the spinal canal (laminectomy or laminotomy). In addition, surgery frequently includes partial or complete facetctomy (removal of all or part of one or more facet joints), to remove the impacted ligamentum flavum or bone tissue. Spinal stenosis surgery is performed under general anesthesia and patients are usually admitted to the hospital for five to seven days after surgery, with full recovery from the surgery that requires between six weeks and three months. Many patients require prolonged therapy in a rehabilitation facility to regain sufficient mobility to live independently.

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Removal of the vertebral bone

INDUSTRIAL as laminectomy and facetectomy occurred, frequently leaves ”the arsa. affected spine very unstable, leading to the need for an additional highly invasive fusion procedure that places extracts demands on the patient's vertebrae and limits the patient's ability to move. Unfortunately, a surgical spinal fusion results in loss of ability to move the fused section of the back, decreasing the patient's range of motion and placing stress on the discs and facet joints of adjacent vertebral segments. Such stresses on adjacent vertebrae frequently lead to further thinning of the spine, back pain, lower leg weakness or pain and / or other symptoms. In addition, using current surgical techniques, gaining sufficient access to the spine to perform a laminectomy, facetectomy, and spinal fusion requires dissection through a wide incision in the back and commonly causes extensive damage to the muscle, leading to significant post-operative pain and prolonged rehabilitation. Thus, while laminectomy, facetectomy, and spinal fusion frequently improve symptoms of neural and neurovascular impact in the short term, these procedures are highly invasive, decrease spinal function, drastically disrupt normal anatomy, and increase long-term morbidity due to above levels seen in untreated patients.

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INDUSTRIAL

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Accordingly, it would be desirable to have less invasive methods and devices for modifying the target tissue in a spine to help improve or treat spinal stenosis, while inhibiting undesirable damage to non-target tissues. Ideally, such techniques and devices would reduce neural and / or neurovascular impact without removing significant amounts of vertebral bone, joint, or other spinal supports, the need for spinal fusion, and ideally, reducing long-term morbidity resulting from currently available surgical treatments. In addition, such techniques can also remove both ligament and bone during spinal stenosis decompression. Such techniques could substantially cut the ligament rather than substantially tear, break or cut it and would remove ligament without leaving a substantial amount of target ligament present after the procedure. It may also be advantageous to have minimally invasive or less invasive tissue modifying devices capable of treating target tissues in parts of the body other than the spine. At least some of these objectives will be satisfied by the present invention.

BRIEF DESCRIPTION OF ΙΛ INVENTION

Improved devices are described herein

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to modify fabrics and methods

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I heard LA m l'UITINDUSTRIAL to use them. These devices can be included as part of a system for modifying tissues. In general, these devices include a plurality of sheets placed on slats (or formed of) that are flexibly attached. The slats can be rigid, somewhat flat, and wider than long (that is, rectangular), or they can be of other shapes. The slats can be arranged ladder-like to a flexible substrate, or to one or more cable (s). Different size slats can be used. The sheets (on the slats) can be arranged towards the side edges of the slats and / or in a staggered arrangement. Any of the devices described herein can be used as part of a tissue decompression method (eg, spinal decompression) to modify tissue such as soft tissue (eg, ligamentum flavum, etc.) and hard tissue (eg. , bone). In particular, these devices can be used as part of a spinal decompression technique within a spinal foramen.

In some variations, a tissue harvesting or tissue capture element (eg, chamber, sack, or the like) can be used to collect the cut or modified tissue.

As mentioned, differently shaped or differently configured slats can be used. For example, a

Τ μ ^D Τ ^J' : / 1/ _ -. . . _. _. _. _ “SCue-My * single device can include two or more different kinds ^ of cutting slats (for example, ran them than ΓιΤΰΙΊΐΥΰΤΓ cutting elements). In some variations, the devices can include two or more regions, in which each region has a different type of slat. For example, slats suitable for side cutting may be located close to or distant from. slats suitable for cutting bone or for cutting material perpendicular to the face of the device.

In any of the variations described herein, the devices can include one or more spacers between individual slats. The spacers can be rigid or flexible and can be configured. The configuration or formation of the spacers can help determine the profile of the cutting surface, and can allow the collection / capture of tissue between the slats. Spacer variations are described herein. A spacer can be attached to the same substrate (eg, wire, mesh, etc.) to which the cutting strips are attached.

The devices described herein may be used as part of a guide-based access and decompression system, including those previously described in any of the patent applications and provisional patent applications, each of which is incorporated by reference herein in its entirety: U.S. Patent Application Serial No. 11 / 250,332,

IΜ ΡI ^c·' '-Y'·;':/'·^Λ'^ entitled DEVICES AND METHODS FOR SELECTIVE SukÓltfXü RENOVAL

OF TISSUE (filed 10/15/2005), US Patent Application Serial No. 11 / 251,199, entitled DEVICES AND METHODS FOR TISSUE ACCESS (10/15/2005), US Patent Application No. do series 11 / 375,265, entitled METHODS AND APPARATUS FOR TISSUE MODIFICATION (filed 3/13/2006), US patent application Serial No. 11 / 405,848, entitled NECHANICAL TISSUE MODIFICATION DEVICES AND METHODS gives the

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Serial No. 11 / 429,377, Entitled FLEXIBLE TISSUE RASP (Filed 4/5/2006), US Patent Application

Serial No. 11 / 538,345, entitled ARTICULATING TISSUE

CUTTING DEVICE (filed 3/10/2006), U.S. Patent Application Serial No. 11 / 687,548, entitled TISSUE

RENOVAL WITH AT LEAST PARTIALLY FLEXIBLE DEVICES (Filed 3/16/2007), US Patent Application Serial No. 11 / 687,558, entitled FLEXIBLE TISSUE RENOVAL DEVICES AND METHODS (Filed 3/16/2007), US Patent Application Serial No. 11 / 870,370, entitled PERCUTANEOUS SPINAL STENOSIS TREATMENT (filed 10/10/2007), and US Patent Application No. serial 12 / 127,535, entitled GUIDEWIRE EXCHANGE SYSTEMS TO TREAT SPINAL STENOSIS (filed 5/27/2008).

In particular, the devices described herein may use a wire guide-based system that is configured such that the

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INSIIT,: ·. _;OF LA l'kon _ IM'USTMAL _ device can be pulled into position and / or tensioned to be driven against a tissue and thereby modify the tissue. This configuration can be referred to as a bi-manual system, since both ends (for example, the proximal end and the distal end of the device) can be tensioned or pulled to modify the tissue. The fabric can be modified by removing or smoothing or softening the fabric and can be accomplished by pulling the devices described herein through the fabric in such a way that the work surface (for example, the sheets on the slats) is set. in contact with one or more surfaces of the fabric.

For example, flexible tissue modifying devices for removing tissue from a patient are described herein. These devices can have a flexible elongated body with an axial length, a width and a thickness, where the axial length is greater than the width and the width is greater than the thickness. These devices may also include: a connector that extends longitudinally along the axial length of the device; a plurality of tissue cutting slats that are flexibly connected by the connector, wherein each slat extends at least partially across the width of the body; at least one cutting edge on each of the fabric cutting slats; and a plurality of separators, where each strip ι? &lt;.,.

________ „η - __________ Z '' 'R ^ ÜIAL__ is separated from an adjacent slat by one or more separators * along the connector.

Another variation of a flexible tissue modifying device for removing tissue from a patient includes: a proximal handle; a connector comprising at least two flexible elongated cables, wherein the cables extend substantially adjacent to each other from the proximal end region of the device to the distal end region of the o -i - · - -i -r -. ,_Ί π _ η ~ _Λ 4.. *- — _ -_ri , _

Cv - -1- -UV j L * A AOl 2 / X- ^l- ~ - - sP -Λ. 'stretch between the cables; a plurality of spacers wherein one or more spacers separate the cutting slats of tissue; and at least one cutting edge on the tissue cutting slats, wherein the at least one cutting edge is sized and configured to cut soft tissue.

This plurality of fabric cutting slats may include slats that have different sizes and / or configurations. For example, the sheets can be placed in different places or have different shapes. The slats can also be of different shapes or sizes. In some variations, the different slats can be grouped together (for a first region, a second region, etc.). Different slats can interact with tissue differently, leading to different ways to cut and manipulate tissue of various types (eg, soft tissue, bone, etc.).

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Any suitable connector can be used. For example, the connector can be at least a cable, a mesh or woven material, a hinged joint, or the like. The fabric cutting strips and spacers can be threaded onto the connector.

Any of these tissue modifying devices may also include a guidewire coupler at the distal end of the device. In some variations, the devices include a side shield member that extends along the length of the elongated flexible body.

In any of the variations described herein, the cutting edge can project from the surface of the slat. Any appropriate cutting edge can be used, as described hereinafter.

The devices can also include a tissue collection region in communication with the slat. In some variations, tissue modifying devices include at least one electrode configured for neural sensing.

Any suitable spacer can be used. For example, the spacer may be configured to provide a passage between adjacent slats. In some variations, the spacer is a splint.

Also described herein

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Müiauj institute

GIVE OWNERSHIP

INDUSTRIAL flexible tissue modification to remove tissue from a patient, comprising: a flexible elongated body having a length, a width and a thickness, wherein the length is greater than the width and the width is greater than the thickness; an anterior surface extending proximally and distantly across the width of the flexible elongated body; a plurality of cutting edges communicating with the anterior surface; wherein the tissue modifying device convertible from which the anterior surface has a first near-distant shape, and a second configuration in which the front surface has a second near-distant shape; and a locking element for locking the proximal to distal shape of the anterior surface of the tissue modifying device.

In some variations, a flexible tissue modifying device for removing tissue from a patient, the device includes: a flexible elongated body having a length, a width, and a thickness, wherein the length is greater than the width and the width is greater than thickness; a plurality of slats that are flexibly connected, wherein each slat extends across the width of the body and forms a front surface; at least one cutting edge on two or more of the slats; wherein the flexible tissue modification device is convertible

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M LA FROPm_Ae of a first configuration, in which the anterior surface has a first near-distant shape, and a second configuration, in which the front surface has a second near-distant shape; and a locking element for locking the proximal to distal shape of the anterior surface of the tissue modifying device.

As mentioned, any of these devices can include a connector, such as a cable that extends proximally and distantly into the device and configured to reshape from near to distal from the anterior surface by applying tension to the cable.

The first shape near to distant from the anterior surface can be linear. The second form close to distant from the. anterior surface may be curved. For example, the second near distant shape can be a C shape, a 3 shape, and so on.

In addition, any of the devices described herein include a guidewire coupler at the distal end of the elongated flexible body. Any of these devices can also include a handle or handle attachment region in communication with the proximal end of the flexible elongated body.

As mentioned, the front surface of the device may include a plurality of flexibly connected slats, each slat extending across the width of the flexible elongated body.

The

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also include a tissue collection region, EaT such as a sack, a bag or the like. The tissue collection region can be expandable.

Also described herein are flexible tissue modifying devices for removing tissue from a patient, the device has a flexible elongated body with an axial length, a width and a thickness, wherein the axial length is greater than the width and the width. is greater than the thickness, the device comprises: a proximal handle; a connector extending longitudinally along the axial length of the device; a first set of tissue cutting slats that are flexibly connected to the connector, wherein the first set of tissue cutting slats includes at least one cutting edge positioned between the side edges of each slat; a second set of tissue cutting slats that are flexibly connected to the connector, wherein the second set of tissue cutting slats includes at least one cutting edge positioned at a lateral edge of the slat; and a guidewire coupler at the distal end.

One aspect of the devices described herein includes a flexible tissue modifying device for removing tissue from a patient. In some embodiments, the device includes a flexible elongated body

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DE LA MOHLUA © U— “yBTjfíJ INDUSTRIAL V ** having an axial length, a width, and a thickness. The axial length is greater than the width and the width is greater than the thickness; The flexible elongated body includes a plurality of slats that are flexibly connected and each slat extends at least partially across the width of the body. The device also includes at least one cutting edge on two or more of the slats. The cutting edges are sized and shaped to cut soft tissue.

In some embodiments, the device for removing tissue from a patient includes at least two flexible elongated leads that extend substantially adjacent to each other from the proximal end of the device to the distal end of the device. The device also includes a plurality of slats each extending between the cables. The device also includes at least one cutting edge on two or more of the slats. The cutting edges are sized and shaped to cut soft tissue.

Each of the plurality of slats may have rounded edges along its length and can be connected such that a first slat is substantially in contact with an adjacent slat along the length of the slat. Cutting edges can project from the surface of the batten. The cutting edge can project from the surface of the slat towards the outer edges of the slat and the cutting edge can be dimensioned and configured to

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DE LA pmwuai&gt; ifV t; industrial cutting a soft tissue band and / or cutting an outline of the band in the soft tissue. '

The cutting edge may include a serrated edge, a hook shape, a concave bend, a rounded convex bend (eg, a tombstone or tombstone shaped edge). The cutting edge can be ax-shaped or hook-shaped. The cutting edge can be sized and configured to engage soft tissue (eg, ligamentum-flavum). Ξ1 strip I can also include an axis around which the cutting edge can rotate.

In some embodiments, the device further includes at least a tensioning jaw on two or more of the slats. The tensioning jaw can be sized and configured to tension soft tissue (eg, ligamentum flavum). In some embodiments, the device further includes at least one raised platform on two or more of the slats. The raised platform may include a first cutting edge and a second cutting edge. The first cutting edge can be sized and configured to cut soft tissue, and the second cutting edge can be sized and configured to engage soft tissue (eg, ligamentum flavum).

In some embodiments, two or more slats include a base portion and at least two leg portions that define a U-shaped cross section.

I ^r'T' · Β · ^ üf LA ΜΜΙιΜΙΙ&gt; «aa ^ KUf'-V industrial leg can be flexible and / or have different lengths. The slat can define an opening sized and configured to receive a cable. The opening can be larger than the diameter of the cable. In some embodiments, two or more slats may have a warped shape. The slat may be dimensioned and configured to engage soft tissue such that the soft tissue bulges into the concave portion of the slat and the cutting edge can project from the surface of the concave portion of the slat. A hooked cutting edge may project from the surface of the concave portion of the slat, towards the center of the slat.

The slat may be dimensioned and configured to engage soft tissue such that the soft tissue is on the convex portion of the slat and the cutting edge can project from the surface of the convex portion of the slat. A hooked cutting edge may project from the surface of the convex portion of the slat, towards the center of the slat.

Another aspect of the devices described herein include a flexible tissue modifying device for removing tissue from a patient. In some embodiments, the device includes at least two flexible elongated cables. The cables can extend substantially adjacent to each other from the proximal end of the device to the distal end of the device. The

<img file="MX348805B_D0016.tif" />

The device further includes at least one cutting edge on at least one flexible elongated wire. In some embodiments, the cutting edge is crimped onto the cable. In some embodiments, the device further includes a plurality of slats and each slat extends between the cables. The device may further include at least one cutting edge on two or more of the slats, in some embodiments the device further includes a second set of at least two flexible elongated cables. The second set of cables extend substantially in line with the first set of cables, and each slat extends between the second set of cables.

Another aspect of the devices described herein include a flexible tissue modifying device for removing tissue from a patient. In some embodiments, the device includes a flexible elongated body that has an axial length, a width, and a thickness. The axial length is greater than the width and the width is greater than the thickness. The device includes a flexible elongated core cable extending from the proximal end of the device to the distal end of the device and the elongated body includes a plurality of slats coupled to the cable. The cable is attached to each slat towards the center of each slat, and each slat extends at least partially across the width of the body. The device also includes per

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FROM INDUSTRIAL PROKIFTY at least one cutting edge on two or more of the slats.

In some embodiments, the device also includes a second set of per Ip minus two flexible elongated cables, attached to each slat at substantially the edge of each slat. The slats may be dimensioned and configured to rotate around the center wire such that the slats maintain a constant oUStancxUxiLient pressure against ex-fabric across the surface of the slat. The slats may be sized and configured to rotate around the center wire, such that the slats maintain substantially constant contact with the fabric across the surface of the slat.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a top view of a vertebra with the cauda equina shown in cross section and two nerve roots branching from the cauda equina to exit the central spinal canal and extend through the intervertebral foramina either on one side or another from the vertebra.

Figure 2A is a partially detailed perspective view of a flexible fabric modifying device that includes a plurality of flexibly connected slats.

Figure 2B is a perspective view of another variation of a tissue modifying device with sheets i or '-^!

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DELA PRDPiEDaÍ) progressively larger and smaller did ^ é ^ as ** 4E ^ long in length.

Figure 2C is another variation of a tissue modifying device.

Figure 2D is another variation of a tissue modifying device that includes two ramp regions.

Figure 3A shows one. variation of a distant end of a tissue modification device, which

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Figure 3B shows another variation of the distal end of a tissue modifying device, including a guidewire coupler.

Figure 4 shows a partial perspective view of a region of a tissue modification device.

Figure 5A is a partial perspective view of another region of a tissue modifying device.

Figure 5B is a partial perspective view of another variation of a tissue modifying device.

Figure 6 shows a variation of flexibly connected slats of a fabric modifying device.

Figure 7 shows another variation of flexibly connected slats of a fabric modifying device.

Figure 8A shows another variation of slats

The flexibly connected T? Í Λ D Τ of a woven device, and Figure 8B illustrates the flexing of the flexibly connected slats illustrated, in Figure 8A.

Figure 9A shows a flexible material that can be used as a connector to connect slats that form a tissue modifying device.

Figure 9B illustrates a variation of a slat that can be used with the connector shown in xa Fiyuiá 3A. Figure 9C illustrates the attachment of the batten of Figure 93 onto the material of Figure 9A, and Figure 9D shows the batten assembled onto the connector material. '

Figure 9E shows an alternative attachment of the batten of Figure 9B onto a material, such as the connector material of Fig.^rFigure 9A, and Figure 9F shows a bottom view of the batten and connector assembly of Figure 9E.

Figure 9G is a partial perspective view of a variation of a tissue modifying device.

Figure 9H is a side cross section through the tissue modifying device of Figure 9G. '

Figure 10 is a bottom view of a tissue modifying device that includes protective side covers.

Figure 11 is a top view of a tissue modifying device including side covers

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Figure 12A is a side view of a variation of a tissue modifying device that includes a fixed minimum open volume tissue harvesting region. ·

Figure 12b is a cross-sectional view through the tissue modifying device of Figure 12A.

Figure 12C is a top view of the tissue modifying device of Figure 12A.

Figure 12D shows a partial perspective view of a portion of a tissue modifying device.

Figure 12E is a top view of the tissue harvesting device of Figure 12D.

Figures 12F and 12G illustrate sections through the device shown in Figure 12D.

Figure 13A shows a variation of a substrate of a tissue harvesting region, such as that shown in Figures 12A-12C.

Figures 13B1-13B3 illustrate a variation of a substrate for a tissue harvesting region in which the substrate can be accordion-shaped.

Figure 14A shows another variation of a substrate for a tissue harvesting region having regions

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US LA ΓΡΟ / ΚΓιΛ '&gt; expandable and semi-rigid regions, and Figure ^ l ^ is ^ t ^ ina top view of a semi-rigid frame for — arta — region¹ ete- · - tissue collection such as that of Figure 14A.

Figure 15A is a cross section through another tissue modifying device having a fixed minimal open volume tissue collection region.

Figure 15B shows a partial side view of a tissue modifying device having a fixed minimum open volume tissue harvesting region.

Figure 15C is a cross section through another tissue modifying device having a fixed minimum open volume tissue collection region.

Figure 16A shows perspective views of two adjacent slats having alternating tissue cutting edges or blades, and Figure 16B shows a side view of both of the two slats illustrated in Figure 16A.

Figure 16C shows a side view of the two slats shown in Figures 16A and 16B when the two slats have been positioned adjacent to each other.

Figure 17A shows a variation of a tissue modifying device having a non-linear axial shape.

Figures 17B-17C illustrate a variation of a tissue modifying device that can be expanded from a first narrower configuration (shown in Fig.

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Figure 17B), to a second larger configuration ^ '^ moS ^ SSS * in Figure 17C). ....... — ..........-......

Figures 17D-17E illustrate another variation of a tissue modifying device that can be expanded from a first narrower configuration (shown in Figure 17D), to a second wider configuration (shown in Figure 17E).

Figure 18 is a partial perspective view of a flexible tissue modifying device having a non-linear axial shape.

Figure 19A is a posterior view of the spinal cord indicating decompression trajectories at the disc level and along the nerve root.

Figure 19B is a posterior view of the spine indicating a decompression path for decompression of the adjacent lateral recess.

Figure 19C is a posterior view of the spine indicating a decompression path for decompression of the central canal.

Figures 20A-21 illustrate a variation of a fabric modifying device slat having a curved shape.

Figures 22A-22B illustrate a variation of a fabric modifying device slat having a U-shaped cross section.

<img file="MX348805B_D0019.tif" />

<img file="MX348805B_D0020.tif" />

INSTITUTO MEXICANO DE LA PMFIEBAD industrial

Figures 23A-23B illustrate another variation of a fabric modifying device slat having a U-shaped cross section.

Figures 24A-F illustrate a variation of the tissue modifying device.

Figure 25 illustrates a variation of slats having angular cutting edges.

Figures 26-32 illustrate cutting edge variations of a tissue modifying device.

Figures 33-34 illustrate variations of cutting edges and tensioning jaws of a tissue modifying device.

Figure 35 illustrates a slat of a tissue modifying device having a raised platform.

Figure 36 illustrates a variation of a cutting edge.

Figures 37-38 illustrate variations of a tissue modifying device having a cutting wire.

Figures 39-40 illustrate variations of a tissue modifying device having a core wire.

Figures 41-42 illustrate variations of a slat from a tissue modifying device.

Figures 43A-F illustrate a variation of a

IΜ? ' 1 INSTITUTO MEXICANO system that includes tools for spinal treatment. This system includes two variants: a guidewire placement probe tool (43A and 43B), a flexible neural localization tool (43C), a tissue modification device (43D), a removable guidewire handle ( 43E), and a guide wire (43F).

Figures 44A-E illustrate a variation of a tissue modifying device that is inserted into tissue and manipulated to modify tissue. Tools such as those shown in Figures 43A-43F can be used for this procedure.

DETAILED DESCRIPTION OF THE INVENTION

Various modalities of tissue modification devices and systems, as well as methods for fabrication and use of tissue modification devices and systems, are provided herein. In general, a flexible tissue modifying device, as described herein, is configured to remove tissue from a patient. In particular, these tissue modifying devices can be configured to decompress spinal stenosis. These devices commonly include a flexible elongated body that extends proximally to distally (proximal / distal), and is configured to be inserted into a patient, such that it extends around tissue.

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OE THE PROPERTY L7 * »- ™ MTjg target, so that it can be pulled K'ffii.áíYiua ^^^ against the target tissue by applying — even to one end or the other of the device. Thus, the device can be extended to, through and / or around a spinal foramen. The device is flexible in at least one plane. For example, in variations in which the device has an elongated ribbon shape that is long and flat with a width greater than the thickness, the device includes a first major surface (e.g., a front) and a second major surface ( a back), and has edges (minor surfaces) between the first and second major surfaces. The first major surface can be referred to as the front surface or the front surface and the second major surface can be referred to as the rear surface or the rear surface. The devices described herein can be flexible along the front and rear surfaces, and the front or front surface can include one or more cutting edges configured to cut tissue as the front surface of the device is urged against tissue. The back surface can be configured to shield or protect non-target tissue.

The tissue modification devices described herein also commonly include one or more of the following: All or a portion of the device may

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INSTITUTO MEXICANO / ^^ eigp ^ iiíS Ji be formed of slats or links connected 'fígjiíblsfte &amp; te;

Devices may include a Tfé “T region^,a'PTTiT'a ”Tte · * ^^ which has a fixed minimum volume; and the device can be configured such that the major / minor surfaces can have non-linear shapes along their length, or they can be knitted between linear and non-linear shapes. A tissue modifying device can include one or more of these elements in any combination. Each of these elements is described and illustrated in greater detail hereinafter.

Although much of the following description and accompanying figures focus generally on surgical procedures on the spine, in alternative modalities, the devices, systems, and methods of the present invention may be used at any of a number of other anatomical sites on the body of the patient. patient. For example, in some embodiments, the flexible tissue modification devices of the present invention can be used in minimally invasive procedures at the shoulder, elbow, wrist, hand, hip, knee, foot, ankle, other joints, or other anatomical sites. in the body. Similarly, although some modalities can be used to remove or otherwise modify ligamentum flavum and / or bone in a spine to treat spinal stenosis, in alternative modalities, other tissues can be modified to treat any of a number of ³⁰ IMPI »¡KST! TI r.) MEXJCANi · LA t'R TIEDAl · / TÍ»

INDUSTRIAL other conditions. For example, in various embodiments, the treated tissues may include but are not limited to ligament, tendon, bone, tumor, cyst, cartilage, scar, osteophyte, inflammatory tissue, and the like. Non-target tissues can include neural tissue and / or neurovascular tissue in some modalities or any of a number of other tissues and / or structures in other modalities. In an alternative embodiment, for example, a flexible tissue modification device can be used to incise a transverse carpal ligament in a wrist while inhibiting damage to the median nerve, to effect a minimally invasive carpal tunnel release procedure. . Thus, various modalities described herein can be used to modify any of a number of different tissues, at any of a number of anatomical sites in the body, to treat any of a variety of different conditions.

Flexibly Connected Slats

In some variations, a fabric modifying device is formed from a plurality of flexibly connected slats. As used herein, a cleat can also be referred to as a link or crossbar. A slat can be rigid (for example, made of a relatively rigid material) or flexible. The slats can be connected to or can form the surface

<img file="MX348805B_D0021.tif" />

IMPI

MEXICAN INSTITUTE

LT The previous main industrial PROPERTY (front). At least some of these slats include one or more cutting edges, which can be configured as blades. The cutting edges can be formed as part of the batten, or attached to the batten.

The individual slats can be of any appropriate shape. For example, a slat can have a rectangular shape, an oval shape, a trapezoidal shape, or the like. In general, the slat is relatively flat (for example, it has a thickness that is substantially less than the length and width). A slat can be smooth, rough or rough or some combination. Different slats in the same device can be of different shapes and sizes, as illustrated hereinafter. A slat can be connected directly or indirectly to adjacent slats.

Some of all slats may be curved. For example, as shown in Figures 20A-20B, slat 2001 has a bow shape. In some embodiments, the warped slat may be sized and configured to cut a slice of fabric 2002, for example, which may be wider than a slice of fabric cut by a non-curved slat. More specifically, the warped slat can be sized and configured to cut a slice of ligament or other flexible and / or soft tissue. For example, the flexible and / or soft tissue can be ligamentum flavum in a patient's spine. In some embodiments, the warped slat may be

MEXICAN INSTITUTE

DF LA PUOPIKOAD dimensioned and configured in such a way that, οδίΗό ™! ^ Il

<img file="MX348805B_D0022.tif" />

In Figure 20A, a concave portion 2003 "of the lstun is brought into contact with the fabric, such that the fabric can bulge or gather within the space defined by the concave portion of the warped slat. Due to the bulging of the fabric, the cutting edges 2004 (as described hereinafter) attached to the slat (particularly, Cui tauteo edges bundled the side edges of the slat) can be brought into contact with the fabric at separate points in addition to the blades. on a non-curved strip it can be brought into contact with the fabric, thereby cutting a wider slice of fabric. In some embodiments, 'the warped slat may be dimensioned and configured such that, as shown in Figure 20B, a convex portion 2005 of the slat is brought into contact with the fabric, such that the fabric can be pulled apart. or stretched over the convex portion of the warped slat. Due to the stretching of the fabric, the cutting edges 2006 (as described below) attached to the slat (particularly, cutting edges towards the side edges of the slat) can be brought into contact with the fabric at separate points in addition that the blades on a slat do not curved can be brought into contact with tissue, thereby cutting a wider slice of tissue. In some embodiments, as shown in Figure 21, a bowed slat 2101 may have

<img file="MX348805B_D0023.tif" />

IMPI ú &lt;! - J Ac.XlCAM 'l - 1.Λ l'ROrlEDAI, INDUSTRIAL cutting edges 2102 attached to the batten towards the center of the batten, in addition to or alternatively to the cutting edges

2103 attached to the batten towards the side edges of the batten. The cutting edges may be hook-shaped as described in more detail hereinafter.

As shown in Figure 22A, the slat may have a U-shape (eg, a rounded U-shape or a square U-shape). The slat may include two leg portions 2201 and a base portion 2202. The leg portions may be perpendicular to the base portion, or they may be configured in any other appropriate manner. The leg portions can be substantially straight or they can have a curved configuration. The slat can define an opening 2204 through which a wire 2205 or other connector can be threaded. In some embodiments, the slat may include a cutting edge 2203. The cutting edge may be coupled to the leg portions of the slat above the opening 2204. As shown in Figure 22B, the U-shaped slats can function to allow the slat legs to pass through soft tissue 2208, such as weave, as the cutting edges cut through the tissue, such so that the base portion of the slat does not catch on the fabric or otherwise obstruct the cutting of the fabric. As shown, a number of U-shaped slats can be attached to a cable to form a. 1ι \!&gt; ΥΜ R! AL »-— ** modifying device. In some embodiments, spacers 2206 can be attached to the cable between two adjacent U-shaped slats. The spacers 2206 may include a cutting edge 2207. In some embodiments, the leg portions may be flexible. As shown in Figures 23A-B, the leg portion 2301 of the U-shaped batten can be made of an expandable or stretchable material, so that as the shear edge increases, the co can be further extended to the tissue (Figure 23B), as long as the base portion 2302 remains on the surface of the tissue and does not catch on the tissue or otherwise obstruct the cutting of the tissue.

The slats are flexibly connected to adjacent slats and / or another portion of the fabric modifying device. A connector, such as a cable, wire, chain, rope, sheet, ribbon, mesh, cloth, or the like, can be used to connect adjacent slats. The connector can be flexible or rigid. A connector can only extend between adjacent slats, or itself. It can extend along all or a portion of the length of the device, such that multiple slats can be attached to the same connector. More than one connector can be used to connect adjacent slats. For example, as shown in Figures 24A-F, the slats can be connected between two

-A parallel wires. As shown in Figures 24B-C7 — the cleats can be coupled to two parallel wires', 3S — so that each cleat is touching or close to touching an adjacent cleat, such that there are substantially no gaps between adjacent cleats. In some embodiments, the edges of the slats are rounded, such that, as the device flexes and bends, the adjacent slats can fold or buckle against each other and / or hinge against each other. Slats spaced in this way (that is, such that the spacing between the slats is tight, and / or there is no space between the slats), can work to reduce the risk of the slat edges tearing the soft tissue. . The slats spaced in this way can allow the slats to move over the soft tissue without tearing it and can allow the cutting edges, attached to the slats, to cut the soft tissue. In some variations, the slats are directly connected to adjacent slats by a hinged joint or the like. Combinations of connectors and direct connections between slats can be used. In some variations, the slats can be separated from each other by a gap. The space can be an opening. In some variations, one or more spacers are used to separate adjacent slats. The spacing between adjacent slats may be different. In variations that include one or more

<img file="MX348805B_D0024.tif" />

INSTITUTE MtXlCANf. For industrial property tissue collection regions, the gaps between slats can provide a passage (or path) between the cutting surface on the front-front surface of the slat, upon which a cutting edge may be located (or may extend from ) and the tissue collection region.

For example, Figure 2A illustrates a variation of a tissue modifying device that has a plurality of slats. Figure 2A is a partially detailed perspective view illustrating enlargements of various regions. The tissue modifying device shown in Figure 2A is flexible and includes individual slats that can be hinged relative to one another. This device included two parallel cables 201, 201 'and a plurality of slats 205, 205', 206, 203 extending between the cables. The cables are the connectors that link adjacent slats. In this example, the two cables are joined at the proximal 233 and distant 235 regions. In some variations, the cable is joined at the proximal and distant ends, or is formed from a single cable; in some variations, the two cables are separate. At least a portion of the cable is flexible. Any suitable cable can be used, including metal cables or polymeric cables. Cables can be single-stranded or multi-stranded. The portion of the cable toward the distal end of the device, as shown in this example, can be hinged and the links o

<img file="MX348805B_D0025.tif" />

Links between distant and proximal sections can be connected in flexible joints. As mentioned, Figure 24A illustrates another variation of a fabric modifying device having a plurality of slats. The tissue modifying device shown in Figure 24A is flexible and includes individual slats that can be hinged together. This device includes two parallel cables and a plurality of slats 2401, 2402, 2403, 2404, 2405, 2406, 2407, for example, extending between the cables.

In some embodiments, the links or slats 205, 205 ', 206, 203 encompass cables that have different shapes and sizes. Each of the slats 203 in the central region includes one or more projecting cutting edges 211 that project from the anterior surface (facing the target tissue). These cutting slats 203 can form a tissue modifying region of the device. The cutting edges shown are triangular or pointed, although any appropriate shape can be used. Furthermore, these cutting edges can be oriented in any desired way; the orientation of the cutting edges can help direct or guide the device as it is propelled against a target tissue to cut tissue. In this example the cutting edges are oriented parallel to the longitudinal axis (the distal / proximal axis) of the device.

In some embodiments, the cutting edge may be

IMPI MEXICAN INSTITUTE OF PROPERTY Ϊ ©

INDUSTRIAL angled inward toward the longitudinal center of the modifying device. In some embodiments, each slat can have cutting edges with the same orientation or each slat can have a different orientation or an alternating orientation. For example, as shown in Figure 25, an adjacent pair of slats may have cutting edges that are angular in opposite directions, such that the cutting edges are oriented or angular toward a center point. In some embodiments, the angular cutting edges can be sized and shaped to guide or collect the tissue toward the center point. More specifically, in some embodiments, the angular cutting edges may be sized and configured to guide or collect ligament or other flexible and / or soft tissues. For example, in some embodiments, the flexible and / or soft tissue can be ligamentum flavum in a patient's spine.

The cutting edges can be one of several appropriate shapes and sizes, or any combination of shapes and sizes. In some embodiments, the cutting edges and / or slats of the tissue modifying device are configured to cut soft tissue, such as ligament. The cutting edges can work to cut the ligament rather than ripping and / or shredding it. Cutting edges can have serrated edges (Figure 26), skid edges (Figure 27), shark tooth shaped edges (Figure i '' A ', · *'. *. · Uí * LU trLl 11 ü I o . '.: uai -: - 3 Jz

DELA r'KJÍlEDAI »V ^^^ ÍXJz'i INDUSTRIAL

28), tombstone or tombstone edges (Figure 29), ax-shaped edges (Figure 30), roller edges (Figure 31), and / or any other appropriate cutting edge shape or configuration. As shown in Figure 26, in some embodiments, a serrated edge includes several smaller edges around a portion of the cutting edge. As shown in Figure 32, for example, in some embodiments, the cutting edge may include serrated portions along the sides 3201 of the cutting edge, while the upper portion 3202 may not have serrated edges. In Figure 32, the cutting edge may have a flat top portion, rather than a pointed top portion. As shown in Figure 27, in some embodiments, a skid edge includes a curved portion of the blade - facing the cutting edge of the blade. As shown in Figure 28, a shark tooth edge can also include a serrated edge, and can have a curved or hooked shape. A headstone or tombstone border can include a rounded border. In some embodiments, the heights of the tombstone or tombstone border may vary from batten to batten.

The variation shown in Figures 24A-F includes both slats having triangular cutting edges (or other appropriately shaped cutting edges) and slats having gravestone shaped cutting edges. In some embodiments, the gravestone-shaped cutting edges are placed to the side

<img file="MX348805B_D0026.tif" />

outer or outer edge of the slat (Figures 24D and 24F), while the triangular shaped cutting edges can be positioned towards the center of the slat (Figure 24E). For example, gravestone cutting edges may be sized and configured to cut flexible and / or soft tissue, which includes ligaments, such as ligamentum flavum in the patient's spine; while the triangular shaped cutting edges may be sized and shaped to cut rigid tissue, including bone, such as the bone of a facet joint, the bone that defines a central canal, and / or the bone that ^ ncural oramcn of^Ίη osuina d ^ l ua ^ i - '^ to including a pedicle. Tombstone cutting edges positioned toward the outer edges of the batten will cut a sash or band of soft tissue. By placing the cutting edge toward the outer edge of the slat, the cutting edge will cut an outline of the slice or band to the soft tissue. A slat may include fixed bone cutting edges soft tissue cutting edges that are flexible or collapsible, such that they engage with tissue and / or pull out of the slat only as desired. Alternatively, the soft tissue cutting edges may be fixed while the bone cutting edges are movable.

In some embodiments, as shown in Figure 30, a cutting edge is ax-shaped. The 3001 sides of the

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INDUSTRIAL ax-shaped cutting edge (that is, leading and trailing edge), can function to hook into and cut a target tissue. More specifically, the sides of the cutting edge can function to engage and slice a soft tissue, such as a ligament, such as a ligamentum flavum in the patient's spine. An upper surface 3002 of the cutting edge can apply pressure to a tissue and cut it. For example, the top surface can apply pressure to a soft tissue against a bone to cut the soft tissue. The upper edge of the blade may also act as a conductor when traveling over the bone to prevent rattling of the modification device, for example to prevent a portion of the device (such as slats) from being trapped in tissue or otherwise. As shown in Figure 33, a portion of the device slats may include ax-shaped cutting edges 3301, while a portion of the slats may include tensioning jaws 3302 that function to pull and flatten soft tissue. In some embodiments, the jaws are low profile and may have a blunt shape, such as a blunt triangular shape or a blunt conical shape. In some embodiments, the jaws are distant from the cutting edges, such that as the device is pulled distantly through the target tissue, the jaws are pulled against the tissue first and foremost.

IΜ ^γ 'INJTIFUTE MUIOANO A can work to tighten tissue. They can then be pulled through the fabric and cut through the tensioned fabric. A modifying device may have cutting edges on slats towards the center of the device, and may have tensioning jaws on slats towards the proximal and distant position of the device. In this embodiment, the tissue can be tensioned as the device is pulled both distally and proximally. In Figure 34, the tension jaws are blunt on one side 3401, and have a sharp, barbed and / or hooked configuration 3402 on the opposite side, such that the opposite side of the jaw can function to engage and remove tissue. For example, the jaw can function to tension the tissue as the device is pulled distantly, and then it can function to engage and remove the tissue as the device is next pulled.

'In some embodiments, as shown in Figure 31, the cutting edges can be roll edges. The cutting edges can have an axis 3101 around which the cutting edge 3102 can rotate. The cutting edge may be circular, but may alternatively have other appropriate shapes, such as oval or polygonal, (eg, a star shape). In some embodiments, the shaft can be coupled to a slat of the device.

In the modes shown in Figure 35, the

<img file="MX348805B_D0027.tif" />

<img file="MX348805B_D0028.tif" />

INSTITUTO MEXICANO L) £ LA Fkl ΨΙ »Ι ΛΙ INDUSTRIAL cutting edge includes a raised platform 3501. In some embodiments, the raised platform is attached to the slat 3502 towards one side of the slat, in such a way that it can be angled up from the slat , as shown. The raised deck may include a first cutting edge 3503 and a second cutting edge 3504. In some embodiments, the first cutting edge is attached to the upper side of the raised deck, and in some embodiments, the second cutting edge is the exposed edge of the raised deck or may be attached to the exposed edge or bottom side of the raised deck. The first cutting edge can be placed towards the outer side or outer edge of the batten.

The first cutting edge can be sized and configured to cut a flexible and / or soft tissue, such as a ligament (eg, ligamentum flavum on the patient's spine). In some embodiments, the second cutting edge is sized and configured to scrape and / or remove soft tissue cut by the first cutting edge. The first cutting edge can be oriented towards the distal end of the tissue modifying device, such that, for example, as the device is pulled into a patient, and / or towards a target anatomy, the first cutting edge cuts the target tissue. In some embodiments, the second cutting edge is oriented toward the proximal end of the tissue modifying device, such that, for example, at

<img file="MX348805B_D0029.tif" />

IMPI

INSTITUTE. ''. Cyica-mO

OF THE .-/,. L '^ TaD i AOJSTkIAL As the device is pulled out of the patient, and / or away from the target anatomy, the second cutting edge can contact and / or engage with the tissue slice, and pull the slice of tissue together with the device.

As shown in Figure 36, the cutting edges can be hooked. In some embodiments, the hooked cutting edges are sized and configured to engage and remove a slice of tissue. More specifically, the hooked cutting edges can be sized and configured to engage with and remove a slice of ligament or other flexible and / or soft tissue. For example, the cutting edges can be configured to remove the ligamentum flavum from the patient's spine. In some embodiments, the tips 3601 of the hooked cutting edges are oriented toward the proximal end of the tissue modifying device, such that, for example, as the device is pulled away from a patient or away From the target anatomy, the tips of the hooked cutting edges can engage the tissue slice and pull the tissue slice together with the device. In some embodiments, the hooked cutting edges may contact and / or engage the slice of tissue by piercing the tissue and engaging the tissue.

The batten may include cutting edges in the shape of a

<img file="MX348805B_D0030.tif" />

T'E LA FROP'FnA »hook towards the center of the slat and cutting edges' in leaf rom (for example, triangular or Se TapidáT shape towards the side or edge of the slat. In some modalities, the side edges works to cutting a slice of tissue and the hooked edges function to contact and / or engage with and remove the slice of tissue. In some embodiments, a portion of the slats may include gandio-shaped cutting edges, while a portion of the slats may have side edges. In some embodiments, the hook slats and the leaf slats alternate, while in some embodiments, one portion of the device includes hook slats and a second portion of the device includes leaf slats.

In some embodiments, the device further includes a wrap that covers the cutting edges while the device is being introduced to the patient. Once the device has been inserted, and / or once a slice of tissue, for example, has been cut, the shell can be removed and the cutting edges hooked (or otherwise appropriate) can be attached. contacting and / or engaging with and removing the tissue slice. In some embodiments, the wrap also functions to remove cut tissue. The hooked cutting edges can be flexible or collapsible, such that when pulled in a distant direction (towards a target tissue), they do not engage the tissue and alternately, when

IMFI

MEXICAN HSTITUTE

DE, THE N «JPIÍ1&gt; aD are pulled

<img file="MX348805B_D0031.tif" />

proximate direction '(far away from an objective tissue), —the. Hooks engage with tissue and can contact and / or engage with and remove tissue. Hook-shaped cutting edges that contact and / or engage tissue can be removed from the patient, pulling along with the tissue. In some modalities, once out of the patient, the user can remove (by suction, irrigation, manually, etc.) the tissue from the hooks. Device 10 can then be reinserted to cut and / or capture additional tissue.

The tissue modifying device can include cutting edges attached directly to a wire, instead of including a slat with a cutting blade. As shown in Figure 37 ol raft 3701 I can include 3702 cutting elements, such as beads, blades, wires or other appropriate cutting elements. In some embodiments, the cutting elements can be crimped onto the wire or attached by other appropriate methods. The cutting cables 20 can cut tissue using energy such as heat or radio frequency energy. The energy can work to dissect and / or shrink the tissue, rather than cutting it. As shown in Figure 37, a portion of the device may include cutting wires, while a portion of the device includes slats threaded over wires (with or without

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L. LA PL1HFDAI V * - INDUSTRIAL ν 'cutting edges on slats). The cutting cables and the cables on which the slats are threaded can be the same or different cables. As shown in Figure 38, a tissue modifying device may include slats 3801 along a portion of the device, and may further include a cutting wire 3802 coupled to the slat portion of the device.

As mentioned above with reference to Figures 22Λ-Β, the cutting wires can be attached to a U-shaped slat. The U-shaped cleat may function to allow the cleat legs to pass through the soft tissue 2208, such as weave, as the cutting edges cut through the base portion 2202 of the cleat otherwise obstructing the U cut can also work to support the cutting wire, and prevent two parallel wires from approaching each other. In some embodiments, spacers 2206 can be attached to the cable between two adjacent U-shaped slats. Standoffs 2206 may include a cutting edge 2207.

The device may include a shield coupled to the cutting cables. The shield can be attached to the cutting wires, such that as long as the wires are adjacent to the target tissue, the shield protects adjacent non-target tissue, such as neural tissue, and / or can tissue, such that the does not get caught on the fabric u of the tea? gone. The listen in form

<img file="MX348805B_D0032.tif" />

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From Ι Α μ:; · γ ¡Ff&gt; aD to collect tissue cut by the cutting wire, in some embodiments, the cutting wires function to slide distantly and proximally into or over substantially stationary armor. In some embodiments, the shield can function to contact and / or engage with and remove a slice of tissue (eg, soft tissue such as ligament) cut by the cutting wires.

In some embodiments, the slats may have varying widths along the length of the tissue modifying device. For example, as shown in Figure 24Ά, the slats towards the far end of the device (eg slats 2401) may be small in width, while the slats towards the proximal end of the device (eg slats 2404, 2405 and 2406) may have a larger one. For example, the small width can be in the order of 1 to 6 mm, while the large width can be in the order of 6 to 8 mm. Thus, there may be an intermediate region along the length of the tissue modifying device (e.g., region having slats 2402) over which the width of the device (roughly the width of the slats in some variations) transitions. from relatively narrow to relatively wider. In some embodiments, there may be half-width slats in the central portion of the device. These transition strips may include sharp edges or may

<img file="MX348805B_D0033.tif" />

IMPI

MEXICAN INSTITUTE

OF LA TH ItDAI '

INDUSTRIAL alternatively be non-cutting slats.

In a variation, as shown in Figure 2B, the cutting edges can have different heights on different slats. For example, in Figure 2B the cutting edges on the slats towards the center of the device 298 may have a first height, while the cutting edges on the slats towards the proximal ends 299 and / or distant ¿93 'úei n¿pOüiL ± vu púcut lcuui one. oeguiiu at height. The first height can be larger than the second height, allowing the device to cut a shallow cut first and then a deeper cut as the device is pulled against the tissue. The cutting edges in this configuration can function to provide a smooth transition as the device is pulled against the tissue and sequentially higher cutting edges begin to engage with the tissue. Alternatively, the second height can be larger than the first height. In some embodiments, as shown in Figure 24, the adjacent cutting edges may have different heights. For example, in Figure 24D, a first set of cutting edges includes a cutting edge that has a first height, a cutting edge that has a second height, and a third cutting edge that also has the first height. In Figure 24D, the second height is higher than the first height. There can be any appropriate number of adjacent shear edges each having either the first height or the second height, and in some variations? There may be a number of cutting edges that have any other appropriate height. As shown in Figure 24F, a tissue modifying device can include a second set of cutting edges that have a third height. For example, Figure 24A, the third height can be higher than the second altars and / or piime-ia aj-cuia. In some iLioaa_LxacLUcs (for example, Figure 24A) the first set of cutting edges may be distant from the second set of cutting edges.

In some variations, the cutting edges are formed from the batten material, and the cutting edge (eg, blade) is machined as part of the batten. For example, a cleat can have a starting thickness that measures the height of the cleat and the sash. Material at this initial thickness is machined (or otherwise removed) to form a series of sheets that project from the surface of the batten. Alternatively, the cutting edges may be cut from the surface of the slat and bent from the surface of the slat, such that the cutting edge or blade is substantially perpendicular to the slat. The cutting edge can be cut by the wire EDM (Electrical Discharge Machining) process, or any other appropriate process. In some embodiments, the cutting edges or blades may be

<img file="MX348805B_D0034.tif" />

INSTITUTO MEXICANO DE LA i'imiMU manufactured separately and connected to the list '&amp; Y?' *¹*¹'

<img file="MX348805B_D0035.tif" />

In Figures 2A and 24^to, the 1 iáTBTTSS ΰUll enlieJjiadufe “on the cables by means of openings or channels formed in the slat. For example, a tissue modifying device, such as the one shown in Figures 2A and 24A can be formed by threading the various components (eg, slats, spacers, etc.) over the cable (s) that the , - . - '·' v&gt; -. ..., - -. , · ·. - ..... · .. .. ..... .... .. neither . qg

UUiiCc UClrl. ± Lli C1 _L Ul ± Cx ¿5 V Clx iClLlUllCO CJ1X lllCiyUÍ. oaCLOlIxC hereinafter), a tissue collection region may be connected underneath the slats. In some variations, the slats may be rings, or may include tissue collection space or a tissue collection region.

In some embodiments, as shown in Figure 2C, crimp elements 272, 272 'can also be threaded onto the cables through openings or channels formed in the crimp elements. Once in place, the elements can be crimped to the cable or attached to the cable in any other appropriate way, such as by welding. The crimping elements attached to the cable function to retain the slats and various other components in place, and may further function to prevent loading of the proximal and / or distal portions and / or ends of the fabric modifying device.

Cables or slats in one or more regions along

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industrial &gt;&gt; and length of the device can be covered or protected. For example, in Figure 2C, the proximal regions of the tissue modifying device include a protective region, such as a solid material or covering element on the cables. Thus, the tissue modifying device may have a solid proximal end protective region or portion 274. This solid portion may be a jjüxiíui ± ca, ucuaiQüiéj extrusion. úuiü macerate upiOp-LciCíu in any appropriate configuration.

A broadening or ramp region or regions may also be included as part of the mod device. ^cr · D - i Qr t ^ idOS ^ΌΟ ^ ^Ί 3 V variation of a tissue modifying device having ramp regions 288, 288 'in the proximal and distant portions of the tissue modifying device, in some embodiments the ramp begins towards the proximal and / or distant ends of the device, to a height approximately level with the device and is increased. For example, the height can be increased to approximately the height of any blades or cutting surfaces, or slightly higher. In some embodiments, the height of the ramp is increased to a height approximately equal to or just below the height of the leaves. The ramp can function to provide a smooth transition as the device is pulled against tissue and cutting edges.

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D i LA FROFI EDA I: iV ΠΓ INDUSTRIAL begin to bond with the fabric. The ramp can extend across multiple slats, a single slat, or they can be attached to the device cables. The ramp can be a solid structure, or a ribbed structure (as shown in Figure 2D).

The slats 203 with cutting edges 211 may extend over a portion of the length of the device. As illustrated in Figure 2Ά, the device may include two or more cutting edge slats or blades 203 (eg, cutting slats). In this example, these cutting slats 203 are separated by a space formed by spacing elements 209 between the slats. These spacer elements are also attached to the connector 201, 201 'that flexibly connects the slats. In Figure 2A, the spacers are threaded over the two parallel cables. The sizes of the connectors and / or spacer elements 209 can be varied to change the spacing between the slats, and also the longitudinal shape (curvature) of the device, as described in greater detail hereinafter. As shown in Figure 2-4D, in some embodiments, a spacer 2408 can be integrated into the slat 2404. The spacer can be sized and configured such that two adjacent slats define a space 2409 between them (the cable 2410 can be seen in space 2409 between adjacent slats).

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Returning to Figure 2A, in addition to “Ίό^ι»^α1- InsWHeS 0 cutters 203, other slats may also H ^ Urinclu! Ídoo qua ...

they do not have a cutting surface. For example, tie slats 205, 205 'can be used. In Figure 2A, the distal tie slats 205 are shown removed from the device, but may be included. These slats can protect the cable, and / or the fabric, and can be of different sizes. Closer to the end αχ¿tant 235 ú &amp; x device shown in Figure 2A, smaller slats 206 can be used to house the cable (s) connecting the slats. These slats 206 can be formed to allow the device to be flexible in one or more directions (eg, up / down relative to the main surface), while limiting flexibility in other directions.

In some embodiments, the cutting slats, non-cutting slats, partitions, or any other appropriate portion of the device may include a tracking element. For example, a tracking element can be arranged at the distal end of the device, such that the tips of the device can be tracked as it is inserted into a patient and / or moved within the patient. Alternatively, the device may include multiple tracking elements arranged along the length of the device, or multiple tracking elements arranged along a portion of the length.

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For example, along the cutting region of the (llspusi'bivo), Ga 'some modalities, the tracking element is a material that is detestable by an imaging system.

Some examples of suitable tracing elements include echogenic materials or substances (that is, configured to form an echogenic surface) detestable by an ultrasound system, and radiopaque materials detestable by a radiography system, such as a fIconoscope. Alternatively, the tracking element can be configured to be detectable by an MRI system or infrared system. In some embodiments, the tracking clement is preferably a coil configured to be detected by an electromagnetic tracking or navigation system. For example, the devices described herein may incorporate a tracking system such as the AXIEM ™ from Electromagnetic Tracking Technology, eg, the StealthStation® AXIEM ™ (Medtronic Navigation, Louisville, CO. USA). In some embodiments, the device is configured to generate an electromagnetic field around the target anatomy of the patient that can be tracked to triangulate the placement of devices having tracking elements.

The proximal end 233 of the device shown in Figure 2a includes a handle 231 that can be permanently or removably attached to the proximal end. The distal end 235 shown in Figure 2A includes a guidewire coupler 237 that is flexibly attached to the distal end of the device. As shown in Figures 24A and B, guidewire coupler 2411 is also flexibly attached to the distal end of the device. In some embodiments, the guidewire coupler has such a tapered shape. So that you have a first width at the Larice end and train an ancno more ampxxo Lacia proximal end of the coupler. In some embodiments, the proximal end of the coupler is substantially the same width as the slats 2401. A wire guide coupler as shown in Figure 2-7, can function to move (and thereby guide the device, tracking) over, under or around soft tissue, such as ligament, rather than cutting or tearing through the fabric.

A guidewire coupler is configured to attach to a guidewire (for example, one end of a guidewire) such that the device can be manipulated, at least in part, by pulling on the guidewire. after the guide wire has been secured to the device. For example, in some variations, a guidewire can be inserted into the body from a first location outside the body, then passed around the target tissue (eg, around a spinal foramen) and out of the body from a second position. The far end of the

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MEXICAN INSTITUTE

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INOJSTUIAl N ^ -W ~ WjÍ &lt;guide wire can then be attached to the flexible tissue modification device (such as that shown in Ta

Figure 2A) and pulled through the body until the tissue modifying region of the device, eg, the portion of the device that includes cutting slats 203, is positioned opposite the target tissue. In some variations the guidewire used includes a tip region that is enlarged and can be engaged with the guidewire coupler. For example, the guide wire may have a proximal end with a flange or ball. This enlarged region can be configured to fit an opening in drop wire coupler 242, such that the guide wire can be pulled distantly from outside the patient. In some variations, the distal end of the device can be fully pulled out so that it can be grasped and manipulated. In other variations, the distal end of the tissue modifying device remains coupled to the guidewire, and the guidewire can be clamped to manipulate the distal end of the tissue modifying device. A handle can be attached to the guide wire.

The overall tissue modifying device shown in Figure 2A has an elongated body formed from the plurality of substantially rigid slats. This variation has a length (an axial length, from near to distant) and a width. The length of the device is longer than the

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ÍÍJJTlTUi O .'AZZí '.' AMO width of each slat. In some embodiments, the 'jMXT ^ r the length of the device to the width of rariR — strip ce greater than five. Alternatively, in some modalities, the proportion may be greater than ten. The device is also relatively slim; in this variation the thickness is smaller than the width of each slat. In some embodiments, the ratio of the width of each slat to the thickness of each slat is ¡iiciyui se sos. nx ^ exiiULxvaiímitt ;, in axguuas unjiid ± ± üaíítt, xa ratio may be greater than five. The use of two cables for the device shown in Figure 2A allows articulation of the links or links.

The distal end of device 235 (which includes the guidewire coupler region) is hinged, as is the connection to proximal end 252. In some variations, the couplings in the proximal and distal regions allow rotation of the connection with respect to to the tissue modification region, such that the torque (twisting motion) is not transferred to the tissue modification region. For example, Figure 3A illustrates a variation of the distal end of the tissue modifying device in which the distal end includes a guidewire coupler 237 that is rotatably connected to the tissue modifying device, more specifically to cable 201, by connector 301. Alternatively, the distal end, which includes a coupler

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of guidewire, it can be rigidly attached to the cable, as shown in Figure 3B. The distal ends of the cable include slats 206 (as shown in Figure 2A), protective portion, or links that cover the cable, and can help prevent tissue damage by presenting a relatively atraumatic surface.

In Figure 2, the flexible portion of the device, the pulses or connecting pieces are attached to the proximal end of the device, which may be flexible overall, and may include a handle or an attachment region for a handle. This interface between the links that form the flexible region and the proximal end is shown as joint 252. The proximal joint 252 near the proximal end 233 is a ball joint 207 to which the cables are attached. The ball joint allows for rotation of the handle and / or proximal portion of the device with respect to the tissue modification region of the device. Thus, the proximal handle can be rotated along the longitudinal axis of the tissue modifying device, but will substantially apply no torque to the tissue modifying region of the device.

The variation shown in Figure 2A may also include a proximal connection region 262 near the proximal end 233 of the device to which the handle 231 is attached. This connecting region can be relatively rigid (or inflexible), or it can also be flexible.

As mentioned • &lt;in operation,

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driven against the target tissue and can be moved in the proximal / distant direction to modify (eg, cut) the target tissue. For example, both of the proximal and distant ends of the tissue modifying device can be pulled to drive the device against the target tissue, and each can be pulled alternately at a direction other than the other to use the device on the tissue. target, allowing the cutting edges to cut and modify the target tissue. In this example, as the blade (s) cuts through the fabric, a moment is generated between the tip of the blade and the base of the blade, above the slat, where the cable runs through of the ribbon. Thus, in some variations, the base of the sheet slat may be wide enough to resist rotation around the length of the cable. In addition, it may be advantageous to include fixed rigid sections.

In some embodiments, as the slats of the device are urged against the target fabric, a portion of one slat may contact the target fabric, while a second portion of the slat cannot. Furthermore, a portion of a slat can be brought into contact with the target tissue with a greater pressure than a second portion of the slat. It may be advantageous to maintain substantially equal pressure and / or substantially equal contact

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INSTITUTO MLXICANC m LA WWíibAD across the width of a slat. This can be obtained ^^{To the}deuñá 'in various ways. For example, slats -can be flexible or hinged. In this embodiment, as the device is urged against the target tissue, the slats can function to conform across their width around the target tissue, thereby maintaining substantially equal pressure and / or substantially equal contact across the width of the a ribbon.

In Figure 39, slats 3901 are coupled to a single load-carrying cable 3902, which runs longitudinally the length of the device, coupled towards the center of the device, such that the slats can rotate around the central cable and hold by this a substantially equal pressure and / or substantially equal contact across the width of a slat. In this manner, the slats of the tissue modifying device will be kept substantially parallel and / or level to the plane of the soft tissue (eg, ligamentum flavum), preventing the device from preferably cutting on one side. In some cases, if the device preferably cuts with one side, the device may be slid under the soft tissue rather than cutting a slice or band of tissue, thereby potentially leaving the target soft tissue behind after the procedure, which can be undesirable. As shown in Figure 39, the slat may include a channel or opening

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3903 towards the center of the slat, such that the slats can be threaded onto a load carrying cable through the opening or channel formed in the center of the slat. The slat may include more than a single load carrying cable towards the center of the width of the device. As shown in Figure 40, the slat 4001 may include openings 4002 to the sides of the slat in addition to the central opening 4003. The slats can be threaded over additional lateral cables. For example, the side cables can include spacers 4004 between the slats as described above.

In some embodiments, as shown in Figure 41, the slat is held at a first height 4101 above a first cable and a second height 4102 above a second cable. As shown, the first height is greater than the second height, such that the slat is at an angle, and can thereby maintain substantially equal pressure and / or substantially equal contact across the width of the slat. As shown in Figure 42, the slat may include a channel or opening 42 01 that is larger than the diameter of the cable 42 02 over which the slat is threaded. As shown, the slat is movable on the cable, such that it can maintain substantially equal pressure and / or substantially equal contact across the width of the slat.

In some modalities, the cable (s) ^^ yiAÍ.qdSgFg ^ BF which (which) the slats are αηΤπΊιι mi · j ^ p_rman_Q^ op loose before inserting the device into a patient. Once the device has been inserted, and the slats are adjacent to the target tissue, the cables can be tightened, such that both sides of the slat contact the tissue and maintain substantially equal pressure and / or substantially equal contact. equal across the width of the slat. In this mode, the cables are tightened to different lengths. In some embodiments, as the device is driven against the target tissue, and pulled in a distant direction, a greater force can be applied to the first cable than to a second cable. Then, as the device is driven against the target tissue, and pulled in a proximal direction, a greater force can be applied to the second cable than to the first cable.

In some embodiments, the cables are stretchable. For example, a first cable can be stretched to a longer length than the second cable, such that both sides of the slat contact the fabric and maintain substantially equal pressure and / or substantially equal contact across the slat width. In some embodiments, the cables and / or slats can be made of a shape memory or elastic material. In this modality, the device can be inserted into a patient in a first configuration, "IMPIAS

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INDUSTRIAL and then, once in position, the device can change shape or reshape to a second configuration, wherein the second configuration is one that conforms to the target tissue, thereby maintaining substantially equal pressure and / or substantially equal contact. across the width of the slat.

As mentioned, the slats forming the device can be flexibly connected by means of hinges between the slats. The connections shown in Figure 2A are flexible connections and individual slats are not connected directly, but are instead connected via a cable. Since the cable is flexible, the bending point is concentrated between the slat and the coupling socket (spacer).

Figure 4 shows a portion of a tissue modifying device similar to that shown in Figure 2A. In Figure 4, each of the cutting slats includes a plurality of cutting edges. These cutting edges are again shown as oriented along the longitudinal axis of the device, although other orientations may be used. The . Cutting edges may be offset from one another along the longitudinal axis of the device, such that a wider cutting area is formed. Alternating adjacent slats can have different cutting edge configurations, such that the cutting edges

λ. - ν .._χ _ F may be offset from each other along^Mll «Ssg &amp; i longitudinal device. For example -— e? ™ ^_co shown in Figure 24E, a first slat may have cutting edges in configuration 2412, such that the position of the blades is driven or biased towards a first side of the device (towards the top of Figure 24A), a second slat may have sharp edges in configuration

2413, in such a way that the position of the blades is driven towards a second side of the device (towards the bottom of Figure 24A), a third slat may have cutting edges in configuration 2412, such that the position of the blades is driven to the first side of the device, and so on.

In addition, the cutting edges may be spaced from the sides of the slats, allowing the edges of the tissue modifying device to be relatively atraumatic. Figure 4 also illustrates spacers between each slat or link, either. on one side or the other of the device (that is, on each of the cables). In Figure 4, different spacers are shown, including relatively long bushings 401, and pearl shaped spacers 403. Different spacers can modify the flexibility of the device.

Figure 5A illustrates a proximal end portion of the tissue modification device shown at τ Μ r - r »Ρ71-^{&gt; ι}

Figure 2Α, which cables are attached to 'fa ^^' untSm¹^^ * / by means of coils 501 that allows the caffleá to give Llexiuiieiü · * during the operation. In some variations, these coils can be springs. .

In some variations, as shown in Figure 5B, the slats that make up the device can be flexibly hinged between the spacer slats. The connections shown in Figure 5B are flexible connections. The individual slats are not directly connected, but instead are connected via a cable. Since the cable is flexible, the bending point is concentrated between each slat. The length of each slat can be designed such that each transition point between each slat is a hinge point. As shown in Figure 5B, the slats can be configured such that a pair of slats define an opening between them. This opening can provide a site through which tissue can travel and / or be collected.

In some embodiments, as shown in Figures 6-8A, a tissue modifying device may include flexibly connected slats or links that do not require connection via the near-distant cable illustrated in Figure 2A. For example, Figures 6-8A show various methods for flexibly connecting slats or links. In Figure 6, two cutting strips

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INSTITUTO MIXICAN. --us the ¡K.-VIE: ai&gt; INDUSTRIAL are joined together in such a way that they move relative to each other as the device is flexed. In this example, the devices are hinged. Figures 7 and 8A illustrate alternative variations similar to Figure 6. In Figures 6-8B, adjacent slats or links are directly connected to each other and can be bent or moved as illustrated by arrows. As shown in Figure 8B, the devices can be bent (at least partially). In Figure 8B, the hinged region can be formed by folding two regions of the adjacent links over each other. In these variations, a separate conector (eg, cable, ote.) Is not necessary to allow adjacent links to flex. Alternatively, the hinged regions may include a hinge pin (not shown).

Figures 9A-9D illustrate another alternative method of connecting adjacent slats or adjacent links to allow flexing or provide flexibility. Figures 9A-9D show an embodiment in which adjacent links are connected via a woven tape to which the slats are secured. A portion of the flexible material is shown in Figure 9A. Any suitable (flexible) material, including mesh, woven, nonwoven and polymeric materials can be used. For example, the flexible material could be made of various materials, for

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EU LA FROPIEDAO example: stainless steel, aramid fibers, ^UST¥ ibra ^^_carbon fiber, glass fibers etc. The slats can be attached to the flexible material by any appropriate method. For example, Figure 9B shows a slat having downward pointed edges configured either to pierce the woven tape or to be folded around the connector material, as illustrated in Figures 9C and 9D. The bottom side of the material, and / or slats can be seen &lt;xOraíiQ.ado &lt;ii molcieai. aa polymer 904 to the material, as illustrated in Figure 911. Ξ1 material can be formed into a tape or band shape. Additional slats (of different or similar dimensions),

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Figures 9Ε and 9F show another variation in which the downward pointed edges of the slats penetrate and pass through the material so that they can be secured to it. For example, in Figure 9Ξ, the downward-pointing edges pierce the material (although the material may also include pre-formed holes). The tip-down regions can then be bent over again to secure the slat to the connector material. Other means can also be used to attach the slat to the connector material. In the example shown in Figures 9E-9G, the edge of the slats is not concurrent with the edge of the tissue modifying device. Figure 9G shows a portion of

MEXICAN INSTITUTE. &gt;

OF THE FKoriEUAH _, .____. , __ ,. χ .___.,. ___industrial an exemplary tissue modifying device that includes a flexible connector connecting multiple slats that have cutting edges extending from them. In Figure 9, the slats are spaced from the edge of the tissue cutting device and an atraumatic edge 903 is included along the outer periphery (along the major surface).

Spacing the slats from the edge in this way can reduce the risk of side cutting. Other variations, including variations that have a connector cable (s), the cable and slats can be protected on the side by separate tube-like elements on the edges that are interlocked with the slats and the slats. cable, as illustrated in Figures 10 and 11. In Figure 10, for example, the cables 1001, 1001 'on either side of the device are covered by a protective cover 1003. The slats 1005 span the distance between the two cables. Figure 11 shows a slightly higher magnification of the tissue modification region of the device shown in Figure 10. In Figure 11, the cutting edges 1101 are shown extending from the slats.

Fixed Tissue Capture Region

The leaf slat stair design described

I Μ Τ Λ a. .l 1 MEXICAN INJTITUTE above for modi fi devices that have flexibly linked slats__pn ^ of inrlm'p spaces between the slats. In some variations, the tissue cutting region can also include holes or openings. These spaces between the slats, holes and / or openings may be part of a tissue capture region, or they may act as pathways or channels to direct the cut tissue to a tissue capture region, as the tissue modification region. modifies and / or removes the tissue, at least a portion of (and preferably most of) the cut tissue can be lodged between the cutting edges or bars and / or between the slats of the device, such that the captured tissue is removed from the patient along with the device as the device is removed from the patient. Alternatively, in some variations, the spacing between the slats can channel the cut tissue to a tissue capture region. As the cutting edges' for example, the triangular teeth shown in some of the above figures) cut through tissue, the tissue can be propelled into a tissue harvesting or capture region. In some variations, the edge of the adjacent slat may cut through tissue as the device is driven against the tissue and moved. In some variations, the edge of the slat may also be sharp or it may include a sharp region. Thus, the fabric can pass through the slats of

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OF THE r ». &gt; NFr ΛΡ &lt;7 ^ - TO! · Ó &amp; í INDUSTRIAL leaves and a tissue collection region. The pressure (commonly upward) of driving the device against the target tissue can therefore assist in packing the tissue to a tissue capture region. In some embodiments, the device may have elements to aid in the movement of the cut tissue. For example, the slats may be designed in such a way that two slats acíyaceiices runcioiia as a vaxvuxa uiiiairüccio ± ia_L, allowing the device to enter through the space between the slats, and then hold them between or under the slats and prevent them from moving. backward. Each slat can flap off an adjacent slat to 'function as a one-way valve. The slats can alternatively be designed in any other appropriate way.

In general, a tissue capture region may require some amount of force or pressure to propel the cut tissue into the capture region. This may be particularly true for expandable tissue capture regions, such as an expandable sac that is attached behind the tissue modification region (eg, behind or within slats that include cutting edges). As the tissue fills the area under the leaves, the sac can expand to accommodate the increased volume. Increased pressure may be required to pack the tissue to the tissue cutting region.

In some applications, it would be beneficial to provide pre-expanded tissue capture regions or tissue capture regions that have a minimum volume that is fixed. The fixed minimum volume is commonly referred to as a fixed open volume. Fixed minimum volume tissue capture regions commonly include a minimum open volume, but this open volume may be increased as the device is put into operation; for example, the volume may be expandable from the fixed minimum open volume. Alternatively, the total volume of the fixed minimum open capture region allows tissue to enter the tissue capture region without having to apply additional force to drive the tissue into the tissue capture region.

In some variations, a tissue ecolection region that has a fixed minimum open space can be defined by the space between the openings to the tissue collection region (which can be the slats over the tissue modification region) and a substrate of tissue collection. The tissue collection substrate is commonly separated from the tissue modifying side of the slats by a thickness that forms the open space. The tissue harvesting region may have a length that extends at least along the tissue modification region.

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Ι, ΜΡΙ i¡-.n&gt; ι υτο mixicani. l't LA ΓΚιΨΙΕϋΑΠ .'NPUSTRIAl of the tissue modifying device (for example, the cutting slats in variations that include slats), but can also be extended proximally / distantly.

For example, Figures 12A-12C illustrate a variation of a tissue modifying device that includes a tissue harvesting region having a fixed minimum open space. Figure 12A shows a section ci. ana see output year j_axgo dcx axis lüiigiLü.CiiXiax &lt;dj.staiit¿ / Pj.uxxíliO) of the device. In this variation, the device includes a plurality of flexibly connected slats 1205 that are connected by a connector (a wire 1215). The slats in the tissue modification region include cutting edges 1209. A tissue collection region 1219 (illustrated in Figure 12B) is formed between the top of the slats 1205 and a tissue collection substrate 1211. In this example , tissue collection substrate 1211 is a semi-rigid substrate element that extends along the proximal / distal length of the device. In some embodiments, the substrate element may additionally include guide elements to move and / or position the tissue in a desired direction, such as towards the outer portions of the device, under the non-cutting slats. For example, a guide element may consist of one or more ridges on the substrate that are in the shape of an arrow or chevron, with the apex of the shape pointing toward the edges.

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INDUSTRIAL _ί external regions of the device. The distal end of this variation also includes a guide wire coupler or region, coupling 1252, and individual links 12 05 can be separated by spacers (shown as bushings) 1245.

Figure 12B shows a cross section through one of the slat elements 1205 shown in Figure 12A. In this variation, the 1205 slat includes two _ _. g ... -¹ *^— i ^r—- t ... L- -,. _. । ... .— - q. 0 ^ * 0 * i '&lt;-CLX ± C.XCO XxXU _y ÜXU U L.XU.VCO UC -LOO Cixclxlxo 1UÜ J-XXJ (Figure 12A) can pass. The top (front) portion of the slat includes a plurality of cutting edges 1209. Within the slat 1205 is a fixed open volume 1219 which is f: η g p-1^Ί '~ b ή' · ”tissue collection 1211 at the bottom of the slat. The tissue collection substrate may be secured within the slat by loops or bands 1223 that extend through the bottom of the slat. Figure 12C shows a top view of the tissue modifying device of Figures 12A and 12B.

The tissue harvesting substrate portion of the tissue modifying device shown in Figures 12A-12C is slidable within the slats (eg, along the bands of the slats). One end of the tissue collection substrate may be fixed (for example, near the distal end of the device) and the other end may include an elastic member or spring member 1272 that

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INjTITMTO .m¿x; CANO DS&gt; ^ • Oh'RDa »industrial, ___ allows the tissue collection substrate to slide as the tissue modification device is bent during operation. Figures 13A-13D illustrate variations of tissue collection substrates that can be used.

For example, in Figure 13A, tissue collection substrate 1211 is a semi-rigid sheet of material, as shown in Figures 12A-12C. The woven collection substrate can be similar to cu.axQu.xer matexiax apiOpiauu, which includes metals or alloys (for example, stainless steel, titanium, NiTi, aluminum, etc.), plastic (for example, PEAK, PET , PP, EP, PET, etc.), and elastic materials. Q. . _ *,, j. □. _ 3 χ. JJ. . J. &lt;, &lt;. .__. · and the.* . ·&gt; _ A. X. . st ... - 4. 4.

use other materials. Since the overall device (including the tissue collection substrate) is generally flexible in the plane that forms the major surfaces, the tissue collection substrate can be bent. Thus, when more rigid materials (eg mesals) are used to form the substrate, the substrate can be relatively thin.

Figures 12D-12G illustrate another variation of a tissue modifying device that includes a tissue harvesting region having a fixed minimum open space. Figure 12D shows a perspective view of a portion of a tissue modifying device that includes a tissue harvesting region 1262. This region

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DELA PROPERTY 'jCVXSLL / ® / TISSUE COLLECTION HAS SIDES AND A REGL ^^AND'dnteE ¥ &amp; F7 and includes a channel through which cables (shown as cables 1266, 1266' in Figure 12D) can pass. The tissue collection region can be a single flexible piece, as indicated in Figure 12D, or it can be a plurality of pieces linked by the connector. In this variation, the tissue harvesting region also includes ¿ÓpC4.C-LUO GL xUO CU-GL-i-LGO XUO XXOGOlrXO Lu.'G.GlGÍII dlCcijGlX, GtÜ Gd. ± so that the connectors can pass through the slats. This is also evident from the top view shown in 'Figure 12Ξ. Figures 12F and 12G illustrate

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tissue modification device that includes a cutting corrod (shown in Figure 12F) and a portion of the chorus tissue modification device is between adjacent cutting slats (shown in Figure 12G).

Alternatively, the tissue collection region may include projections projecting into a gap or slot formed on the slats; the connectors can pass through these projections and through the slats. Additionally, spacers (eg bushings, beads, etc.) can be used between the slats.

In some variations, the substrate can be configured to expand / contract as the tissue modifying device is flexed. For example, as described

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variations, the tissue collection substrate pdédé¹ It will be connected at one (or both) axial ends via a spring or elastic element. Figures 13B1 to 13B3 illustrate a side view of another variation of a substrate that is configured to accordion along its length as the device is attached and folded. For example, CU.G1Í1U.Ü UxDpÜDx L ± vO CIÓ HIL / Úx -L JL / CxU-LUll ClC LCJ 1ÜUO ¿Ó 1 J_ _L U11UUU or folded in a first direction, the substrate can be contracted or closed accordion, as shown in Figure

13B1. In the relaxed state, the substrate is neutral with sample in Figure '13B2. When the tissue modifying device is bent in a second direction, the connrln η '' .'Ό η ί o ._- xz *. · - -k- k&gt; _z x_Z &lt;zk N— X— &lt;.__ - .y.¹ XX - ——--- -X _ k Zxx - --- ----&gt; -. .—- '—- - - Xk - xz -' xL x XX, v 'xz x. . —- N_- x. shown in Figure 13B3.

In an alternative variation, the substrate is expandable, and includes a rigid edge with an expandable element between, as illustrated in Figure 14A. In this variation, the rigid portion can be secured to the tissue collection device (eg, to the links of a tissue collection device), and the expandable portion can be made of a mesh or thin plastic material. Figure 14B shows only the rigid portion of a variation of this embodiment, in which the rigid frame 1401 surrounding

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an expandable portion 1403 includes studs 1407. Substrates that include expandable regions may be useful to allow the tissue collection region to expand even beyond the minimum fixed volume, allowing additional tissue collection even after the minimum fixed volume is full.

In general, the tissue collection substrate pLlC: U.¿l DC1 Ιί1θ11χύ.θ11Χ ^ υ CÁX müjyvÚA LX v uúJiUUb by one or more connectors that link the tissue collection substrate to the slat. In Figures 12A-12C, the tissue harvesting region is bounded by the substrate of

-V- .op - pτ-ί A p ° E 7 A p pi]. · Ό pppc; .o rr? i vp A p -. 1 my^Ί pi ir p AP - · ._ · V- V&gt; —- 'v'v'VAV / AX kR. q- v. v- _J -i_ va. Vj_ vi v- t— v&gt; Ca. O v- -q VA. -or. He. dd VA. —- v- aa _ VA. u, VV Va. the * ± d goes. A. _ goes. do loop that is formed by the slat. In some variations, the connectors are not part of the slats, but rather are gIO '^ O'Tv ^ S GGpQAAÓOC ΡθΊΓ C ^ CTpTO / TclS 2_ Λ. - - 2_ 5 C - 1A C v 1 * 3. Ώ.

variations in which the tissue collection substrate is secured to the device by a cable or stem connector between each slat and the tissue collection substrate. In some variations, the connector is formed as part of the tissue collection substrate. Figure 15A shows a cross section through a flexible fabric modifying device having slats 1501 and a tissue collection region 1509 that is formed between the top of slat 1501 and a substrate 1511 that is secured to the slat by a pair of 1515, 1515 'or iNSTnim mexican cables!

CE LA ΡΓ.ΟΡΙΕΗΛΙ 'Cn »BLw,. _ „. - - _. . . , indpstivv offshoots. Figure 15C shows a similar variation in which the substrate is secured to the slat by connectors that can swing or slide. As described, the batten shown can be flexibly connected via one or more cables.

1503, 1503 '. In all these examples of tissue harvesting regions there is an open, minimum volume that has a fixed minimum, such that, even when flexed, the tissue IcCúieCCiÓn region υχ &lt;_χχ · α uu cdeaíCxu oLxulLü UO ρΐυ ^ ΐ . in such a way that the tissue can enter the space. In some variations, this minimum fixed gap is formed by a gap of between about 2 and about 6mm between the slat that forms the top of the gap and the substrate.

Figure 15B shows a cross section at fA Ά Av A d or 4- or -nr * Aro A ro t ηΐ Ί A 'Ί tissue modifying device including a tissue collection strip and pattern shown in Figure 15A. As before, the tissue harvesting substrate in this example is shown axially connected to the device via a spring 1511.

In operation, tissue cut by the blades can be harvested to the tissue harvesting regions described. As mentioned, the openings between the slats can act as channels or pathways through which the cut tissue can pass to the harvesting region (s).

<img file="MX348805B_D0044.tif" />

In some variations, the tissue modifying device may include apertures adjacent the cutting edge (s) through which tissue can pass. Although the examples described above include tissue harvesting regions having a fixed minimum open volume as part of a tissue modifying device comprising a plurality of slats, a region of lécuiecciuii Ge uc vu ± uíucii Cáu-lc-l Lo Fixed minimum can be incorporated as part of any 10 tissue collection region, even those without slats.

Other examples of tissue capture mechanisms that may be used are described, for example, in US Patent 11 / 687,558 (entitled FLEXIBLE TISSUE REMOVAL DEVICES AND METHODS), filed 3/16/2007, and US 11 / 687,548 1 c! a- ή 4-11 Ί mi n wrrcTTr L ·^TJT^mnbm 'r F^tAND^v1BLE

DEVICES), filed 3/16/2007, and US 11 / 952,934 (titled TISSUE REMOVAL DEVICES AND METHODS), filed 7/12/2007; these 'references are all incorporated by reference herein.

As mentioned above, the spacing and orientation of the cutting edges of tissue modifying devices can be arranged to optimize performance. For example, Figures 16A through 16C illustrate an arrangement of cutting edges (blades) in which adjacent slats 25 have blades that are offset from one another. The

Μ? Ι · Ο&gt; β '' 'VC.no .-------- .CCVI'A.',. NOUS ERIAL shifting the blades in this manner may allow them to cut more evenly as the device is set to modify the tissue. Blade density can be important when it comes to cutting both soft tissue and bone. To improve density and allow material to pass through the blade teeth, the front and next blades can be intergraded. Figures 16A-16C show interdigitation of a set of sheets. The first slat 1601 (Slat A) cuts a forward path and the second slat 1603 (Slat B) cuts a next path. This arrangement of cutting edges and slats can help. ICLz. □ _ ΙΪΙ - - XCL LL.lU C u. O. of X. ÍLÁ ¡C L- 1 CX 1 JC CX - CE U1 - .. .... .. 2 XX L of C 01&gt; _ U. ..... Figure 16C is a side view] of Strip A directly in front of Strip-B.

Nonlinear Forms and Shape Morpheus

In addition to the substantially linear tissue modifying devices described above, any of these tissue modifying devices can also be configured to have a non-linear shape (eg, axial shape) and / or be morpheus shape devices that can be converted between linear and nonlinear shapes. Non-linear devices can be pre-formed to a curved or bent shape (such as s-shaped devices, or serpentine-shaped devices, co-shaped devices and the like).

Alternatively, a

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^:T0 MFXICANU: Linear fxüpiedao can be a “tte — füTiiid — morpheus device that can be changed from a linear to a non-linear form, either before or during use of the device to modify tissue.

The phrase linear and non-linear shapes commonly refers to the shape of the device along the main (distant / proximal) axis, when looking down the main (tissue modifying) surface.

For example, Figure 17A illustrates a device having an S (or serpentine) shape. This is a non-linear device (since the main surface does not travel in a line, but is curved). The device can be constructed using the cable cleat (or wire) cleat design, as illustrated in Figure 18. In Figure 18, the links o κ OVH r \ '• OO prl-n · ^ VV - &gt;&gt; -&gt; / -Ί v ~ .r-.v- &lt;v- r-, / -&gt; C '¹ C SOI¹ Unequal in length from one side of the device (for example, a cable) to the other. This difference in spacing causes the device to bend, as shown. For example, the side of a device with a larger radius of curvature may include spacers such as relatively long bushings 401 (shown in Figure 4), and the side of a device with a smaller radius of curvature may include spacers similar to cord 403 (shown in Figure 4). Curved devices can have a longer stroke length when cutting tissue and can therefore cut

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Df la »· κο? Ιε? Λη &lt;_ * - !! juFL. &lt;r industrial a wider region of tissue. For a given stroke length, the amplitude (peak to peak of the curve) becomes the effective width of the device, producing a wider kick than the individual slat.

Additionally, the devices can be deployed to the spine in a linear configuration and then changed to a non-linear configuration. This shape conversion can be obtained in situ by pulling on a cable on one side of the slat more than the other side. Alternatively, both sides can be pulled with the same tension in combination with variably compressible bushings / spacers between the slats at selected locations. For example, to obtain a concave curve to the device on the right side, the right side would have more compressible (elastomeric) bushings than

Or η ”, '' '' ⁿ i '' rl zN T Tvi —¡ ^τ τρ ^π i C -Ό^L - τ · - -q '' ít '* 1 Q V- q Q linear, the cable wire (s) could be locked in position near the proximal end and / or handle. If desired, the cables could be readjusted to form a linear shape to the device prior to removal of the device. For example, a device can be increased in width by moving parallel links from an oblique angle to a connectable perpendicular, shown in the images below.

In some variations, shape morpheus devices can be transitioned between a first straight configuration (eg, linear) and a second configuration.

ΟιΡΙ ^^ • '' SnjUTO MEXICANO straight configuration, with the first configurationiÑoqÍSá '_Lnarrower than the second setting. Two ^ j ^ mp¹These are shown in Figures 17B-17C and 17D-17E. In Figure 17B the tissue modifying device has a relatively narrow profile and can be expanded to a wider profile as illustrated in Figure 17C. The slats in Figure 17B are initially diagonal in relation to the parallel cables that flexibly connect them. By pulling on one of the cables, one side of the device to which the slats are connected can be pulled to align the slats perpendicular to the longitudinal axis of the device. Since the slats are relatively rigid, this will expand the width of the tissue modifying device, as indicated in Figure 17C. 17η v 17P in.nt-vnr. ,, v,_n v ··! r- ϊ ή ”qi 7- 4 1 q in which the tissue modifying device can be expanded from a first linear configuration, in which the slats are Chevron-shaped when viewed from the top as in Figure 17D, to a second linear configuration that is wider, in which the slats can be pulled such that they are perpendicular to the longitudinal axis (proximal / distant axis) of the device, as illustrated in Figure 17E. In this variation, a cable, pull wire or the like can be connected to the slats to convert them from the first shape to the second shape. The . IΜ ΡI

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INDUSTRIAL slats can be adapted (eg hinged) for conversion. In some variations, each run actually consists of two slats that are joined end to end.

Decompression of Spinal Regions

Any of the tissue modification devices described herein can be used to decompress one or more spinal regions, as mentioned above. In particular, any of these devices can be used to decompress nerve roots placed within the spinal anatomy along various trajectories, including those shown in Figures 19-19C. Because these devices are flexible, and can be appropriately sized and shaped to fit inside pg 1 ¹ ro moiTvgT, o S ¿Ι "¹'S ^' OS Q ^{1 1} ” ⁷¹¹ 002S0 to access appropriate regions of the spine from a single access point (eg, from the midline or region near the midline of the patient). The procedure can be used to decompress spinal nerve roots on the unilateral or bilateral side of the access point. A probe or guide can be introduced into the spinal epidural space (or along or just inside the ligamentoum flavum) at an appropriate spinal level using image guidance and / or tracking (eg, electromagnetic tracking). In some modalities, in which the probe or guide can be inserted just into the

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IN OU S Ί '&lt;¡L ^ u _ ^ - ligamentoum flavum, the device can be used to cut a portion of the ligamentoum flavum and in some cases can be used to cut a portion of the underlying bone, while leaving the surface of the ligamentoum intact flavum. The introduction can be either. via a percutaneous puncture or open laminotomy.

As shown in Figure 19Ά, the device can be used to decompress an ipsilateral or contralateral proximal nerve (in a lateral recess). A guide can be deployed immediately cephalad to the caudal segment pedicle on the appropriate side (eg, site 1810). This access point can be confirmed radiographically. If the nerve structures adjacent to the guidewire cannot be directly visualized, the ratio of these structures to the guidewire or tissue modification devices can be determined using electrical stimulation, ultrasound imaging, endoscopic means, or other techniques. In some variations, once the guide is deployed and the optional neural location is complete, a guide wire 20 is passed via the channel guide. The guidewire may be sharp on its distal end and penetrate the skin dorsolaterally after exiting the foramen. The guidewire may include a wire exchange tip on its proximal end, as mentioned above. As shown in Figure 19A, the guidewire can be

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r._t ι.Λ i'POl'IEDAÍ),,,,, „. industrial&gt; S * w ** Bí threaded along a path from the site laTü'a where it exits through the foramen, as shown by at least 05 one of the arrows 1812 (for ipsilateral decompression of the root origin of nerve at the disc level) and 1814 (for contralateral decompression of the nerve root origin at the disc level). In some modalities, the probe / guide is removed once the guide wire has been placed.

Next, a flexible tissue modifying device is attached to the proximal wire exchange tip and a distant handle can be secured to the distant wire tip. The device can then be introduced into the epidural space and then into the lateral recess by gentle upward force applied to the distal handle. In some modalities, the device is pulled by the guidewire along the path through the spinal anatomy. As described above, appropriate trajectories include trajectories shown by arrows 1812 and 1814 to decompress the nerve root origin to the disc level. Once the device is in place as confirmed visually or radiographically, bimanual reciprocating strokes can be used to decompress the dorsal impacting bone or soft tissue at the nerve root origin. In some modalities, approximately 30-40 alternate strokes are required to complete decompression. This can be confirmed radiographically or by palpation by

-------——---- UNHEADED instruments. The device can then be

INDUSTRIAL wire removed.

The probe / guide can be reinserted to decompress the distant ipsilateral or contralateral (foraminal) portion of the nerve root, such that the same tissue modification device (or a different one) can be used to decompress another region of the spine. (or nerve root) using the same site of access or entry. Thus, a guide can be deployed immediately caudal to the causal segment pedicle on the appropriate side. The guide can be deployed at the same access point (site 1810) as described above. Transforaminal placement and relationship to neural elements can again be confirmed visually, radiographically, and / or with electrical stimulation, ultrasound, or alternative means. A voice that the proper location is confirmed, the guide wing can be passed through and the probe / guide removed. As shown in Figure 19A, the guidewire can be threaded along a path from site 1810 to where it exits through the foramen, as shown by at least one of arrows 1816 (for ipsilateral decompression along along the nerve root) and 1818 (for contralateral decompression along the nerve root). A handle is attached to the distant guidewire and the tissue modifying device to the proximal exchange tip. Then the device is introduced to iNSiiTu.oa: ex: cah ···

L'C LA LROPItHAO | Λ- * Rr «t industrial the spine (eg, the epidural space or the region anterior to the posterior border of the ligamentoum flavum) with careful upward force applied to the distant shaft. In some modalities, the device is pulled by the eyeglass wire on the path through the spinal anatomy. As described above and as shown in Figure 19A, appropriate trajectories include trajectories shown by arrows 1816 and 1818 to decompress along the nerve root. Foraminal decompression is performed using bimanual reciprocating strokes to remove impacted bone and soft tissue. In some modalities, approximately 30-40 strokes are required to decompress the root. Confirmation of decompression can be done radiographically or by using instruments to palpate along the root. The device can then be detached and the guidewire removed.

As shown in Figure 19B, the devices described herein can be used to decompress the ipsilateral or contralateral regions (not shown), or both regions adjacent to the level near the nerve root (lateral recess). A guide can be deployed at the same access point (site 1810) as described above. Transioraminal placement and relationship to neural elements are once again confirmed visually, radiographically, and / or with electrical stimulation, ultrasound, or alternative means. Once the appropriate locator is, confirmed

<img file="MX348805B_D0046.tif" />

can be passed and the probe / guide rCTOTiji'X Cuno c and mn ^ gt-ra _ in Figure 19B, the guidewire can then be threaded along a path from site 210 to where it exits through the foramen , as shown by arrow 220 (for ipsilateral decompression of adjacent nerve root origin). A handle can be attached to the distal guidewire and the guidewire can then be attached to the distal end of one of the tissue modifying devices described herein. The device can then be inserted into the spine by pulling on the guide wire. In some embodiments, the decompression device is pulled by the guidewire along the path through the spinal anatomy as illustrated in Figures 19Ά, 19B, or 19C. As described above, and as shown in Figure 19B, appropriate trajectories include the trajectory shown by arrow 1820 adjacent to the nerve root origin. Lateral recess decompression can be performed using bimanual reciprocating strokes to remove impacted bone and soft tissue. In some modalities, approximately 30-40 strokes are required to decompress the nerve. Confirmation of decompression can be done radiographically or using instruments to palpate along the root.

As shown in Figure 19C, a probe / guide can be used to introduce a tissue modifying device as described herein to decompress the central canal. The guide can be deployed at the same access point (site 1810) as described above. Once the proper location is confirmed, the guidewire can be passed and the probe / guide removed. As shown in Figure 5, the guidewire can be threaded along a path from site 1810 to where it exits through the intralaminar window, as shown by arrow 1822 (not the adjacent foramen). A handle can be attached to the distal guidewire, and the tissue modifying device can be attached to the proximal end of the guidewire. The device can then be introduced into the epidural space by pulling the distal end of the guidewire along the path through the spinal anatomy, removing the device adjacent to the target tissue in the spinal canal. As described above, and as shown in Figure 19C, appropriate trajectories include the trajectory shown by arrow 1822 to decompress tissue associated with the central canal and may be effective in treating patients with central spinal stenosis. Decompression can be accomplished using bimanual reciprocating strokes to remove impacted bone and soft tissue. In some modes, approximately 30-40 strokes are required to decompress the

<img file="MX348805B_D0047.tif" />

root.

Confirmation of decompression radiographically or using instruments to palpate the length of the nerve.

In some embodiments, the probe, guide, or guidewire may also include a tracking element or a plurality of tracking elements. The tracking element may be similar to the tracking element of the tissue modification device. As described above, in some embodiments, the tracking element is a material that is detected by an imaging system, while in some embodiments. The tracking element is preferably a coil configured to be detected by an electromagnetic tracking or navigation system.

Any of the procedures described herein can be done in combination with other techniques that include an open or minimally invasive decompression procedure where tools such as rongeurs and powered drills are used to remove tissue primarily around the proximal end of the tube. nerve root (lateral recess). Such techniques can include laminotomies, etc.

Figures 43A-F illustrate a variation of a system that includes one embodiment of the tissue modifying device described above. Any of the tissue modification devices (and modalities of

I .Μ I IN511! '&gt; U MEXICAN ___ ____. ^. j____. , ___ __, ____DE LA / ROI'IETAD these devices) described in the present®isrMpueeeJE_í5? Er included in a system for the treatment ^ —e &amp; fewaftsjj — eseiüaX *. In this variation, the system includes two types of tools to place a guidewire (43F), as shown in the

Figures 43A and 43B. These tools are commonly cannulated devices that can be used to place the guidewire around the target tissue. These fluted tools can be steerable or they can have distal ends that are curved and / or extensible for directing the guidewire around the target tissue. During guidewire placement, the placement of one or more nerves can be configured using a neural locating device (for example, Figure 43C) that is configured to be placed by pulling it into place using the guidewire, similar to the method described herein for placing the tissue modifying device into operation. The neural localization device may include one or more electrodes to create a localized electromagnetic field capable of stimulating only nearby nerves (thereby confirming that they are adjacent to the guidewire path, or one or more sides of the guidewire pathway). guide) . In some variations, the tissue modifying device includes one or more neural locating devices. A handle can also be included, to attach to the guide wire, better

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• UICANO υ-tzOMciwn guide wire control. For example, eñ '^ he¹ shown in Figures 43A-43F, the handle '(' 1 '1 and Ufa — Φ9Ε) isLá- * configured to connect to the guidewire (Figure 43F), allowing the distal end of the guidewire to be pulled when the end proximal of the guidewire is attached to the tool (eg, tissue modifying device, Figure 43D).

Any of the devices illustrated herein can be used to modify tissue, as discussed above. Figures 44A-44E illustrate one embodiment of a method for modifying tissue using one of the flexible tissue modifying devices 10 described herein. In Figures 44Ά-44Ε, the patient's skin, TT target tissue, and NTT non-target tissue are shown schematically, rather than as specific structures. In one embodiment, the method of Figures 44A-44E can be employed on the spine, to remove ligamentum flavum, bone, or both, with it. device 10 that passes through an intervertebral foramen between two vertebrae. In other modalities, other tissue in other areas of the body can be removed.

As shown in Figure 44A, the guidewire 22 with the sharpened tip 23 and the formed end 27 can be passed into the skin, between the target tissue and non-target tissue, and out of the skin. The guide wire can also be referred to as a pull wire, since it is used

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INDUSTRIAL to pull one or more devices into position, as described. Methods for passing the guide wire / pull wire 22 are further described, for example, in US Patent Application Nos. 11 / 457,416, 11 / 463,247 and 11 / 468,252, which were previously incorporated by reference. As described in those references, in various embodiments, guidewire 22 can be positioned using a percutaneous method, such as with a needle, or using an open method, such as with a probe. In some embodiments, neural tissue localization, such as with nerve stimulation over a guidewire passing the probe or guidewire passing the guide element, can be used to confirm that the guidewire 22 is done. pass between the target tissue and the non-target tissue. For example, a neural locating device (as shown in Figure 43C, above) can be used when pulling into position using the guide wire / pull wire.

In some embodiments, where the method is performed on the spine, one or more substances or devices may be placed in the epidural space of the spine before or after placement of guidewire 22, to create additional space between target tissues, such as such as ligamentum flavum, and non-target tissues, such as cauda equina and nerve root. Substances can include, for example, any of a number of fluids or gels, such as Instituto Mexicano OS LA PR&gt; i'IEI) AL&gt; _ medium. , _. ,. . INDUSTRIAL Ns radiographic contrast. The devices can include, for example, a barrier or shielding device. Injection of substances into the epidural space to create a safety zone is described in U.S. Patent Application Serial No. 11 / 193,557 (Publication No. 2006/0036211), entitled Spinal Ligament Modification Kit, assigned to X-Sten, Inc., and filed July 29, 2005, the entire disclosure of which is incorporated herein by reference. Various barrier devices for spinal placement are described, for example, in U.S. Patent Application Serial No. 11 / 405,859 (Attorney Docket No. 026445-000722US), entitled Tissue Modification Barrier Devices and Methods, and filed April 17, 2005, the entire disclosure of which is incorporated herein by reference.

Referring to Figure 44B, the distal handle 24 (another variation of which is shown in Figure 43E), can be passed over the sharp point 23 and tightened around the guide wire 22, such as by moving the clamping lever. 25. In some variations, the handle captures or otherwise retains the sharp distal tip, to prevent injury or interference. Distant handle 24 can be engaged with guidewire 22 at this point in the process or at a later point in the process, according to various embodiments.

As shown in Figure 44C,

<img file="MX348805B_D0049.tif" />

can then be coupled with the near faithful tí'iyputlLivw 11, by coupling the end of the formed guidewire 27 (not visible) with the guidewire coupler 18. In the embodiment shown, for example, the formed end of the wire Guide 27 can be attached to coupling element 18 (hollow pointed arrow).

Referring to Figure 44D, the distal handle 24 can then be pulled (hollow pointed arrow) to pull the device 10 onto the patient and thus place the tissue modifying elements 16 in contact with the target tissue.

TT. In some embodiments, such as when device 10 is used in a spinal procedure and passes through an intervertebral foramen, the surgeon or other medical user may use tactile feedback from device 10 passing into the foramen, such as when the coupling element 18 and / or tissue modifying elements 16 pass into the foramen, to determine when the tissue modifying elements 16 are positioned at a desired site in relation to the target tissue TT. Alternatively or additionally, the surgeon can confirm that a desired placement has been obtained by using radiographic imaging, such as fluoroscopy, direct visualization, such as in an open surgery case, or a combination of multiple methods.

In some modes, in which the device

<img file="MX348805B_D0050.tif" />

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DE LA I HOPIEDAI industrial 10 is used in the spine to treat spinal stenosis and / or neural or neurovascular shock, the device 10 can be passed to the patient and to a position to modify tissue without removing any vertebral bone. More specifically, in some embodiments, device 10 can be advanced to the patient through an intervertebral foramen, and out of the patient without removing bone. This is contrary to most current surgical methods for the treatment of spinal stenosis, which commonly include removal of at least some vertebral bone, such as performing a laminotomy or laminectomy, and which frequently remove significant amounts of the vertebral lamina. , spinous process, facet and / or pedicular bone tissue, simply to access the surgical site. In one embodiment, for example, device 10 can be manually advanced to the patient, used to remove ligamentum flavum only and removed from the patient without removing any vertebral bone.

As shown in Figure 44E, once the tissue modifying elements 16 (e.g., slats including tissue modifying surfaces, as described above) are positioned as desired, relative to the target tissue TT, the proximal handle 20 and guidewire handle 2 4 can be pulled (hollow pointed arrows) to drive the rate modifying elements

NST1TUTO MEXICAN

LIE INDUSTRIAL EROEIETY tissue 16 against TT target tissue (single-headed arrows with continuous tip). As long as the pulling / tensioning forces are maintained, the handles 20, 24 can be used to alternately move the device 10 (double headed arrow, solid line tips) to remove the target tissue TT. In some variations, the tissue modifying device includes a rigid proximal shaft portion 13 (or rigid or rigidifiable somi) that can be used to help direct the device 10 or more specifically the flexible distant shaft portion 14 relative to the target tissue TT. For example, a rigid shaft portion 13 can be used to move the flexible portion 14 laterally or to pivot the shaft 12 about an axis positioned along the flexible portion 14. In one embodiment, for example, the rigid portion 13 can be used to manipulate the flexible portion 14 within an intervertebral foramen, such as by pivoting the shaft 12 or moving the flexible portion 14 laterally in a caudad direction and / or headache, relative to the patient. The stiffness of the rigid proximal shaft portion 13 can generally facilitate such targeting, compared to a fully flexible device.

When a desired amount of tissue is removed, the device 10 can be removed from the patient, such as by detaching the guidewire handle 24 from the guidewire.

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-,. -, -,,. ^ Laphoíuiia »and when 3alar the next handle 20 to extract the^Notdí »sposí ^^^^r and guide wire 22 out of .......¹____ Π11 qignngg modalities, device 10 or an additional device can be reinserted into the patient and used at a second site to remove additional tissue. For example, in a spinal stenosis treatment procedure, device 10 can be used to remove tissue from (and thus decompress) a first intervertebral foramen and can then be removed and reinserted to remove tissue from a second foramen. This process can be repeated to remove tissue from any number of foramina. In one embodiment, device 10 may include a guidewire lumen, such that a guidewire can be placed in a second foramen while device 10 is in the epidural space of the patient. Device 10 can then be removed along with the first figure 22, attached to the second blind wire, and reinserted into the second foramen to remove tissue. In some embodiments, tissue can be removed from device 10 before device 10 is reinserted into the patient to remove more tissue.

Although various illustrative embodiments are described above, any of a number of changes can be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps

101

ΓΜΡΙ are performed they can frequently be INDUSTRIAL alternative modalities and in other modalities, one or more method steps can be omitted altogether. Optional elements of various device and method modalities may be included in some modalities and not in others. Accordingly, the foregoing description is provided primarily for exemplary purposes and should not be construed to limit the scope of the invention as summarized in the claims.