WO2009143496A1 - Devices and methods for spinal reduction, displacement and resection - Google Patents

Devices and methods for spinal reduction, displacement and resection

Info

Publication number
WO2009143496A1
WO2009143496A1 PCT/US2009/045088 US2009045088W WO2009143496A1 WO 2009143496 A1 WO2009143496 A1 WO 2009143496A1 US 2009045088 W US2009045088 W US 2009045088W WO 2009143496 A1 WO2009143496 A1 WO 2009143496A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
deformable
element
member
device
rod
Prior art date
Application number
PCT/US2009/045088
Other languages
French (fr)
Inventor
James Marino
Jamil Elbanna
Original Assignee
Trinity Orthopedics, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613Component parts
    • A61B17/1615Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
    • A61B17/1617Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material with mobile or detachable parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine

Abstract

Disclosed are minimally-invasive methods, devices and systems for performing multiple therapeutic procedures in the spine through small access portals of sufficient dimension that minimize trauma to the patient and surrounding tissue. The devices described herein use the mechanical principals of radial expansion resulting from linear approximation of an elastic or hinged element that can be deformed. The deformable element can be biased to displace or bend in a particular direction such as away from an axis of shortening thereby providing space in which a spinal treatment can be performed or wherein the space created is the spinal treatment desired. Additionally, the expanded dimensions of the device can be used to manipulate tissue, as in reduction, dissection, or resection efforts.

Description

DEVICES AND METHODS FOR SPINAL REDUCTION, DISPLACEMENT AND RESECTION

REFERENCE TO PRIORITY DOCUMENT

[0001] This application claims priority of U.S. Provisional Patent Application Serial Number 61/055,392, entitled "DEVICES AND METHODS FOR SPINAL REDUCTION, DISPLACEMENT AND RESECTION" by J. Marino, filed May 22, 2008. Priority of the filing date of May 22, 2008 is hereby claimed, and the disclosure of the Provisional Patent Application is hereby incorporated by reference.

BACKGROUND

[0002] A significant number of adults have had an episode of back pain or chronic back pain emanating from a region of the spinal column or backbone. Many people suffering chronic back pain or an injury requiring immediate intervention resort to surgical intervention to alleviate their pain. A number of spinal disorders are caused by traumatic spinal injuries, disease processes, aging processes, and congenital abnormalities that cause pain, reduce the flexibility of the spine, decrease the load bearing capability of the spine, shorten the length of the spine, and/or distort the normal curvature of the spine.

[0003] Disc degeneration can contribute to back pain. With age, the nucleus pulposus of the intervertebral discs tends to become less fluid and more viscous. Dehydration of the intervertebral disc and other degenerative effects can cause severe pain in many instances. Annular fissures may be associated with a herniation or rupture of the annulus causing the nucleus to bulge outward or extrude out through the fissure and impinge upon the spinal column or nerves (a "ruptured" or "slipped" disc). [0004] In addition to spinal deformities that occur over several motion segments, spondylolisthesis (forward displacement of one vertebra over another, usually in the lumbar or cervical spine) is associated with significant axial and/or radicular pain. Anterior column distortion is often accompanied by or caused by a fracture or partial collapse of one or more vertebrae (usually resulting from osteoporosis or traumatic injury) and/or degeneration of a disc. Patients who suffer from such conditions can experience diminished ability to bear loads, loss of mobility, extreme and debilitating pain, and oftentimes suffer neurological deficit in nerve function.

[0005] Traditional, conservative methods of treatment include bed rest, pain and muscle relaxant medication, physical therapy or steroid injection. Failure of conservative therapies to treat spinal pain often lead to spinal surgical intervention, with or without instrumentation. Fusion of the vertebrae above and below the degenerate intervertebral disc form a single, solid piece of bone.

[0006] Many surgical techniques, instruments and spinal disc implants have been described that are intended to provide less invasive, percutaneous, or minimally invasive access to a degenerated intervertebral spinal disc. Instruments are introduced through the annulus for performing a discectomy and implanting bone growth materials or biomaterials or spinal disc implants within the annulus. One or more annular incisions are made into the disc to receive spinal disc implants or bone growth material to promote fusion or to receive a pre-formed, artificial, functional disc replacement implant.

[0007] Extensive perineural dissection and bone preparation can be necessary for some of these techniques. In addition, the disruption of annular or periannular structures can result in loss of stability or nerve injury. As a result, the spinal column can be further weakened and/or result in surgery-induced pain syndromes. SUMMARY

[0008] There remains a need for minimally-invasive methods, devices and systems for performing multiple therapeutic procedures in the spine through small access portals of sufficient dimension that minimize trauma to the patient.

[0009] Disclosed are devices for treating a spinal structure. In an embodiment, the device includes an elongate member having an outer sheath and an inner rod, the elongate member having a longitudinal axis. The device also includes a deformable member coupled to a distal end portion of the elongate member, the deformable member having a plurality of leaflets each having at least one cutting edge, wherein the deformable member has an initial insertion configuration for placement adjacent a spinal structure and a radially expanded configuration. The device also includes an actuator coupled to the inner rod of the elongate member. The actuator gradually deforms the deformable member from the initial insertion configuration towards the radially expanded configuration upon linear foreshortening of the elongate member along the longitudinal axis. The device also includes a handle coupled to the elongate member and adapted to gradually rotate around the longitudinal axis of the elongate member such that when the deformable member is radially expanded the at least one cutting edge contacts tissue of the adjacent spinal structure. The deformable member can also hinge outward such as by articulating elements moving by a scissor-jack mechanism.

[0010] Also disclosed are methods for treating a spinal structure that includes the steps of creating at least one intraosseous transpedicular pathway in a posterior pedicle of a vertebra; accessing an adjacent spinal structure through at least a portion of the pathway; introducing a device through the pathway to the adjacent spinal structure; and deforming the deformable member using the actuator to linearly foreshorten the elongate member along the longitudinal axis. The deformable member can bow outwardly and radially expand. The deformable member can also hinge outward such as by articulating elements moving by a scissor-jack mechanism.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 shows a perspective view of an embodiment of a spine treatment device.

[0012] Figures 2A-2D shows a perspective view of the distal end of an embodiment of the device in different stages of expansion.

[0013] Figure 3 shows an exploded view of the device shown in Figure 1.

[0014] Figure 4 shows a cross-sectional view of a distal portion of the device shown in Figure 1.

[0015] Figures 5A-5F show perspective views of various embodiments of a deformable element of the device.

[0016] Figure 6A shows a cross-sectional view of the device shown in Figure 1.

[0017] Figure 6B shows an enlarged view of Figure 6A taken at circle BB.

[0018] Figure 7 shows a side view of a vertebra having an intraosseous transpedicular channel and access entry to the disc space.

[0019] Figures 8 and 9 show perspective views of an embodiment of the device being delivered through a working channel of a cannula. [0020] Figure 10 shows the device in Figures 8 and 9 in the expanded position.

[0021] Figure 11 shows an embodiment of a reduction device according to one embodiment.

[0022] Figure 12 shows an embodiment of a reduction device according to one embodiment.

[0023] Figures 13A-D show an embodiment of a spine treatment device having a hinged deformable element.

DETAILED DESCRIPTION

[0024] Disclosed are methods and devices for accessing and treating the spine, while minimizing trauma to surrounding tissue. The present disclosure relates generally to spinal surgery, particularly methods and apparatus for forming one or more intraosseous access bores in a minimally invasive, low trauma, manner and providing a therapy to the spine employing the intraosseous bore. The devices described herein use the mechanical principals of radial expansion of an elastic or hinged element that can be deformed resulting from linear approximation of proximal and distal elements of the device. The deformable element can be biased to displace or bend in a particular direction such as away from an axis of shortening thereby providing space in which a spinal treatment can be performed or wherein the space created is the spinal treatment desired. Additionally, the expanded dimensions of the device can be used to manipulate tissue, as in reduction, dissection, or resection efforts.

[0025] Figure 1 shows an embodiment of an instrument 10 for treatment of the spine according to one embodiment. The instrument 10 is useful for the preparation of a space or cavity, for example preparing a space within an intervertebral disc. In an embodiment, the instrument 10 can be useful for intrabody and interbody applications such as, for example, reduction of compression fractures including vertebral compression fractures, bone compression or compacting of cancellous bone within the vertebral body, vertebroplasty, kyphoplasty or re-expanding collapsed intervertebral discs, distracting a space between adjacent vertebral bodies, such as the vertebral disc space. It should be further understood that instrument 10 can be used in association with applications outside of the spinal field, such as, for example, to treat other types of structures or body cavities like the appendicular portions of the skeletal system, a blood vessel or other body cavities such as those associated with the genitourinary tract.

[0026] Still with respect to FIG. 1 , instrument 10 includes an actuator mechanism 15 coupled to an elongate member 20 extending along a generally longitudinal axis L. The elongate member 20 is coupled at its proximal end to the actuator mechanism 15 and has a deformable element 215 at its distal end portion. The deformable element 215 is configured to outwardly expand or bow in response to a mechanically induced force effected, for example, by the actuation of the actuator mechanism 15. This will be discussed in more detail below. The elements of the instrument 10, including the deformable element 215 can be radiodense to provide more simple and convenient methods of visualizing their use with radiologic monitoring as compared to methods using balloons made of radiolucent elastomers that generally require radiodense fluid to expand them.

[0027] As best shown in FIGS. 2A-2D, the deformable element 215 can be gradually actuated between a contracted configuration and an expanded configuration and any configuration in between. The contracted configuration (such as seen in FIG. 2A) encompasses a structural configuration of the deformable element 215 that is suitable for placement in or adjacent to a spinal structure. The expanded configuration (such as seen in FIG. 2D) encompasses a structural configuration of the deformable element 215 that is suitable for displacement, compression, reduction and/or resecting of at least a portion of a spinal structure. In one embodiment, the spinal structure is an intervertebral disc. In another embodiment, the spinal structure is a vertebral body, and displacement, compression, reduction and/or resecting of the vertebral body could be associated with either intrabody or interbody applications.

[0028] The expansion of the deformable element 215 is shown in FIGS. 2A-2D as being generally radially uniform. However, it is also contemplated herein that the instrument 10 and its deformable element 215 can apply forces to displace, compress and/or reduce structures along a specific axis or vector. For example, the deformable element 215 can apply forces away from a narrow insertional axis. This is in contrast to devices that expand with air or liquid and are often limited to uniform expansion or devices that expand along only one plane. The deformable element 215 can be relatively restrained along an axis near one or both of its ends and biased to expand radially from that axis. In an embodiment, the deformable element 215 has one or more elements that bow outwardly in response to linear foreshortening. In an embodiment, foreshortening can be accomplished by an axially deployed shaft fixed to one end of the element and translatable to the other. This is discussed in more detail below.

[0029] Referring now to FIG. 3, the elongate member 20 includes an outer sleeve member 205 and an inner rod member 210. The outer sleeve 205 extends generally along the longitudinal axis L of the instrument 10 and defines an inner passage sized to slidably receive the inner rod member 210 therethrough. The proximal ends of the outer sleeve 205 is coupled to an actuator mechanism, for example via a slip plane. The inner rod member 210 is coupled at its proximal end to an actuator mechanism 15, such as a handle, and the deformable element 215 at its distal end. [0030] The illustrated embodiment depicts an inner rod 210 and outer sleeve 205 as having generally linear configurations. It should be understood that they could take on other configurations as well, for example a curvilinear configuration. Further, the inner rod 210 and outer sleeve 205 are shown as having substantially circular cross sections. It should be understood that other shapes and configurations are also contemplated herein, for example, elliptical, fusiform, square, rectangular or other polygonal configurations.

[0031] Similarly, the deformable element 215 is shown in the figures as having a substantially tubular shape. It is contemplated herein that the deformable element 215 can also have other shapes, for example elliptical, fusiform, square, rectangular or other polygonal configurations. Although the deformable element 215 has been illustrated and described as being formed as a single-piece, unitary structure, it should be understood that the deformable element 215 could be formed of separate elements and coupled together by any known method, such as, for example, by fastening, such as with hinges, welding or adhesion. The deformable element 215 can also be formed as a single-piece structure with the elongate element 20 or the deformable element 215 can be interchangeable with the elongate element 20.

[0032] The inner rod member 210 can be formed of a substantially rigid medical grade material such as, for example, titanium or titanium alloys, cobalt chrome alloys, various forms of plastic, or stainless steel.

[0033] The deformable element 215 can be formed of a flexible material that is capable of the expanding and contracting configurations. The deformable element 215 can be formed of materials including, but not limited to, titanium, stainless steel, spring-tempered stainless steel, an elastic metal, a composite material, a shape-memory material such as Nitinol™ or other superelastic SMA. Other materials such as an elastomeric polymer are also considered. [0034] The proximal and/or distal end(s) of the outer sleeve 205 can be discontinuous along the circumference. For example, a slit can be cut in at least one end of the outer sleeve 205 to permit the introduction of an inner rod 210 that has a non-uniform outer dimension such as a fusiform shape. Further, the discontinuity of the outer sleeve 205 can bias the expansion of the deformable element 215 away from the axis of foreshortening. The discontinuity of the outer sleeve 205 can be contained by a collar or the like so as to preserve the mechanical integrity of the design.

[0035] The inner rod member 210 can have a substantially elongate shape. As best shown in FIG. 4, the distal end of the inner rod 210 includes a reduced diameter intermediate portion 305 and a rounded tapered portion 310. In one embodiment, the intermediate portion 305 has a diameter smaller than the diameter of the rounded tapered portion 310 defining a shoulder region 315. The deformable element 215 is disposed within this intermediate portion 305 between the shoulder region 315 at its distal end and the outer sleeve 205 at its proximal end. In an embodiment as shown in FIG. 4, the deformable element 215 is disposed within the intermediate portion 305 between the shoulder region 315 and a collar 320 disposed around the inner rod 210, the arrangement and function of which is to be described in more detail below.

[0036] The deformable element 215 is configured to outwardly bow upon actuation of the device such that it can be useful for reduction as well as for removing, abrading, resecting or shearing surrounding tissue near or adjacent the insertion region. Referring now to FIGS. 5A-5F, the deformable element 215 includes a series of reliefs or stays cut along its length resulting in at least one slot 405 extending generally along the longitudinal axis L of the instrument 10 defining longitudinally extending flexible strips of material or leaflets 410. The slots 405 and leaflets 410 are provided to facilitate outward bowing of the deformable element 215 beyond the dimensions of the distal end of the instrument 10 in at least one predetermined direction upon the selective actuation of the actuator mechanism 15. In an embodiment, the deformable element 215 includes a pair of slots 405 disposed generally opposite one another defining a pair of leaflets 410 (see in particular FIGS 5C-5F). It should be understood, however, that any number of longitudinally extending slots 405, including one or more slots 405, defining a corresponding number of longitudinally extending flexible leaflets 410 are contemplated here.

[0037] The slots 405 and leaflets 410 can be substantially identical in shape and configuration. It should be understood, however, that the slots 405 and leaflets 410 can take on different shapes and configurations having variable edge designs, such as shown in FIGS. 5A-5F. For example, the leaflets 410 can have a sharp serpiginous or serrated edges to improve their cutting effectiveness. The variable edge designs of the leaflets 410 can be provided as interchangeable "cartridges" or a kit of various cutting blades. The geometry of the slots 405 and leaflets 410 can be varied to produce not only a more effective cutting surface, but also to improve durability. For example, proximal and distal bases that are wider than the middle section imparts added durability to the device. The geometry of the slots 405 and leaflets 410 can also improve asymmetric or nonuniform expansion. In one embodiment, the slots 405 and leaflets 410 have a uniform shape. In another embodiment, the slots 405 and leaflets 410 have a non-uniform shape. In an embodiment, the slots 405 can be relatively narrow and straight as shown in FIGS. 5A and 5B. In another embodiment, the slots 405 and leaflets 410 have a shape as shown in FIGS. 5C-5F having a series of arcuate portions.

[0038] In the contracted state, the leaflets 410 can be disposed convex to the distal axis of the elongate element 20. This can be accomplished by a portion of the inner rod 210 having a region with, for example a fusiform shape. Such design elements would ensure that when each of the otherwise independent leaflets 410 are foreshortened along their longitudinal axes, the leaflets 410 bow outward rather than buckle inward. [0039] As mentioned above and best shown in FIG. 4, the deformable element 215 is disposed within the intermediate portion 305 of the inner rod 210 between the shoulder region 315 distally and the outer sleeve 205 proximally. In one embodiment the proximal end of the deformable element 215 makes contact with the outer sleeve 205 via the collar 320. The collar 320 can be secured near the distal end of the inner rod 210 by a fastener or pin 325. The pin 325 extends through apertures 330 in the collar 320 and a channel 335 in the inner rod 210. The arrangement of the collar 320, pin 325, and channel 335 with the inner rod 210 and outer sleeve 205 allow for linear displacement or foreshortening between the inner rod 210 and outer sleeve 205 up to a pre-determined set- point. This arrangement results in the deformable element 215 gradually expanding and contracting within a pre-set range of outward radial dimensions. Additionally, the pin 325 or some variant thereof, can provide an additional means of imparting torque from rotation of the handle, the handle attached to the inner rod 210) to the collar 320 and thus, to the deformable element 215. This torque transfer arrangement can be augmented by the interlocking geometry of the inner rod 210 with the deformable element 215 distally.

[0040] In one embodiment, the linear displacement of the outer sleeve 205 and collar 320 in a distal direction (arrow D in Figure 4) past the inner rod 210 displaced in the proximal direction (arrow P in Figure 4) results in contraction of the deformable element 215. The shoulder 315 presses against the deformable element 215 at its distal end whereas the collar 320 presses against the deformable element 215 at its proximal end. The linear foreshortening of the elongate element 20 causes the proximal and distal ends of the deformable element 215 to approach one another resulting in the bowing outward of the leaflets 410 of the deformable element 215. The pin/channel interaction can set a limit on the degree of outward expansion of which the device is capable. It should be noted that the mechanism need not include movement of both the outer sleeve 205 and the inner rod 210, but can also involve only distal movement of the outer sleeve 205 or only proximal movement of the inner rod 210 to effect an outward expansion of the deformable element 215 that is disposed therebetween.

[0041] Linear foreshortening of the elongate element 20 occurs upon actuation of the actuator mechanism 15 (best shown in FIGS. 6A-6B). The actuator mechanism 15 includes a movable handle 505, a stationary handle 510, and an actuator member 515. The movable handle 505 is coupled to the stationary handle 510 by way of one or more fasteners 560 with the actuator member 515 disposed therebetween. The one or more fasteners 560 extend through an aperture 580 in the movable handle 505 contacting a flange 575 on the stationary handle 510. This arrangement allows for the movable handle 505 to remain coupled to the stationary handle 510 yet still be movable with respect to the stationary handle 510, for example rotated.

[0042] As mentioned above, the actuator member 515 is disposed between the movable and stationary handles 505, 510. In one embodiment, the actuator member 515 includes a threaded shank portion 520 and an unthreaded shank portion 525. The threaded shank portion 520 is configured to threadingly engage a partially threaded bore 530 in the movable handle 505. The unthreaded shank portion 525 of the actuator member 515 is disposed within a recess 565 near the proximal end of the stationary handle 510 where the stationary handle 510 couples to the movable handle 505. As the movable handle 505 is rotated, the threads of the shank portion 520 and the threads of the bore 530 engage and result in proximal movement of the actuator member 515.

[0043] The actuator member 515 includes a socket 535 extending therethrough that is aligned with a socket 540 in the stationary handle 510. The sockets 535, 540 accept the proximal portion of the inner rod 210. The proximal portion of the inner rod 210 is affixed within the socket 535 of the actuator member 515 by one or more fasteners 545. The fasteners 545 can be threaded through apertures 555 in the stationary handle, through apertures 550 in the unthreaded shank portion 525 such that they extend into apertures 570 in the proximal portion of the inner rod 210. The one or more fasteners 545 couple the rod 210 to the actuator member 515.

[0044] As the movable handle 505 is rotated and the threads of the shank portion 520 and the threads of the bore 530 engage resulting in proximal movement of the actuator member 515, the inner rod 210 likewise moves in the proximal direction. Linear displacement of the actuator member 515 (and the inner rod 210 coupled thereto) along the longitudinal axis L of the instrument 10, for example by rotary movement of the movable handle 505, results in linear displacement of the inner rod 210 relative to the outer sleeve 205 resulting in a foreshortening of the elongate element 20. Foreshortening of the elongate element 20 causes the deformable element 215 to expand in configuration. The outer sleeve 205 pushes distally and the inner rod 210 pulls proximally such that the leaflets 410 move outwardly. In one embodiment, the threaded shank portion 520 and the bore 530 each define right hand threads. Thus, linear foreshorting occurs upon rotation of the movable handle 505 in a clockwise direction and linear lengthening occurs upon rotation of the movable handle 505 in a counterclockwise direction. Described above is one embodiment of an actuation mechanism and it should be appreciated that other actuation mechanisms can be used.

[0045] Displacement of the movable handle 505 relative to the stationary handle 510, such as in a clockwise direction (assuming right hand threading) will cause the actuator member 515 to be linearly displaced in the direction of arrow P, which will correspondingly cause the inner rod 210 to be linearly displaced in the direction of arrow P. Because the distal end of the inner rod 210 is engaged with the deformable element 215, linear displacement of the rod 210 in the direction of arrow P will cause the deformable element 215 to expand outwardly toward the expanded configuration as shown in FIG. 5. In such an embodiment, it should be apparent that displacement of the movable handle 505 relative to stationary handle 510 in an opposite direction will cause the actuator member 515 to be linearly displaced in the direction of arrow D, which will correspondingly cause the inner rod 210 to be linearly displaced in the direction of arrow D. Linear displacement of the rod 210 in the direction of arrow D will cause the deformable element 215 to reform back toward the contracted configuration.

[0046] The movable handle 505 can have a variety of configurations, such as for example, what is shown in FIGS. 1, 2, and 3. The movable handle 505 can also have other configurations such as, for example, what is shown in FIGS. 8 and 9. The movable handle 505 can also include a pair of lateral extensions extending outwardly defining a T-handle arrangement to aid the surgeon in moving the handle 505 relative to the stationary handle 510. It is contemplated herein other configurations that aid and assist the surgeon in securely gripping the instrument 10 and maintaining the handles 505, 510 in a stationary or moveable position, such as for example during rotation. The moveable and stationary handles 505, 510 can be generally conical shape and can include outer surface ribs that provide comfort and non-slip surface for the surgeon.

[0047] Although one specific embodiment of the actuator mechanism 15 has been illustrated and described herein, it should be understood that the use of other types and configurations of actuator mechanisms are also contemplated as would occur to one of skill in the art. As should be apparent, any type of actuator mechanism that is capable of imparting relative displacement between the inner rod 210 and outer sleeve 205 to reform the deformable element 215 between the contracted and expanded configurations can be used. It should further be understood that the rod 210 can be manually displaced by the surgeon relative to sleeve 205, thereby eliminating the need for a separate actuator mechanism 15.

[0048] Figures 11-13 show embodiments of instruments that employ a scissor-jack mechanism for deforming the distal end. Figures 11 and 12 illustrate embodiments of instruments that employ a scissor-jack mechanism of resection and/or reduction. These instruments effect reduction at angles approaching 90 degrees to the axis of the pedicle fixture. Outer sleeve 1105 translates along inner rod 1110 producing articulation of elements 1115, 1120 and a force normal to the axis of outer sleeve 1105 and inner rod 1110. FIG. 12 shows an alternative embodiment of the device to effect reduction having two pairs of articulating elements 1115a, b and 1120a, b.

[0049] Figures 13A-D show another embodiment of an instrument 1310 that employs a scissor-jack mechanism of resection and/or reduction. The instrument 1310 includes an actuator mechanism 1320 coupled to an elongate member 1325 extending along a generally longitudinal axis L. The elongate member 1325 is coupled at its proximal end to the actuator mechanism 1320 and has a hinged deformable element 1315 at its distal end portion. The deformable element 1315 is configured to apply force outwardly to displace, compress and/or reduce structures along a specific axis or vector that is away from a narrow insertional axis L in response to a mechanically induced force effected, for example, by the actuation of the actuator mechanism 1320 or linear foreshortening accomplished by an axially deployed shaft, as discussed in more detail below. The deformable element 1315 is also capable of resection of surrounding tissues.

[0050] As best shown in FIGS. 13C and 13D, the deformable element 1315 is hinged and includes two articulation elements 1330, 1335 with a cylindrical segment 1340 coupled between them. Articulation element 1330 is coupled at one end to the forked distal end 1380 of the inner rod 1345 by a pin 1350 or the like and the opposite end of the articulation element 1330 is coupled to the cylindrical segment 1340 also by a pin 1355 or the like. Similarly, articulation element 1335 is coupled at one end to a cap member 1370 by a pin 1360 or the like and at the opposite end of the articulation element 1335 is coupled to the cylindrical segment 1340 also by a pin 1365 or the like. The pins 1350, 1355, 1360, 1365 allow for the articulation elements 1330, 1335 and associated cylindrical segment 1340 to hinge outward upon linear foreshortening of the elongate element 1325 by telescoping the inner rod 1345 with respect to the outer shaft 1375. It should be appreciated instrument 1310 can have more than one cylindrical segment and associated articulation elements.

[0051] The deformable element 1315 can be gradually actuated between a contracted configuration and an expanded configuration where the cylindrical segment 1340 juts outward from the longitudinal axis of the elongate element 1325. The deformable element 1315 can also take on any configuration in between the contracted and expanded configurations. The contracted configuration (such as seen in FIG. 13B) encompasses a structural configuration of the deformable element 1315 that is suitable for placement in or adjacent to a spinal structure. The expanded configuration (such as seen in FIG. 13B) encompasses a structural configuration of the deformable element 1315 that is suitable for displacement, compression, reduction and/or resecting of at least a portion of a spinal structure. In one embodiment, the spinal structure is an intervertebral disc and the cylindrical segment 1340 has sharpened edges that are configured to shear or resect tissue upon actuation or rotation of the instrument 1310. In another embodiment, the spinal structure is a vertebral body, and displacement, compression, reduction and/or resecting of the vertebral body could be associated with either intrabody or interbody applications.

Methods of Use

[0052] As described above, the instruments 10, 1310 can be useful for the preparation of a space or cavity, for example preparing a space within an intervertebral disc by abrading, removing, resecting or shearing surrounding tissue near or adjacent the insertion region to provide access to the disc space and prepare the disc space for further procedures. In an embodiment, the instruments 10, 1310 can be useful for intrabody and interbody applications such as, for example, reduction of compression fractures including vertebral compression fractures, bone compression or compacting of cancellous bone within the vertebral body, vertebroplasty, kyphoplasty or re-expanding collapsed intervertebral discs, distracting a space between adjacent vertebral bodies, such as the vertebral disc space. In one embodiment, the spinal structure treated is an intervertebral disc and resecting of the intervertebral disc tissue is considered. In another embodiment, the spinal structure treated is a vertebral body, and displacement, compression, reduction and/or resecting of the vertebral body could be associated with either intrabody or interbody applications.

[0053] Referring now to FIGS. 7-10, an exemplary method of using the described system and devices for disc resection is now described. At least one pathway is formed in the patient to provide access to the disc space to be treated. For example, an intraosseous transpedicular entry 705 can be formed, for example an entry hole in the posterior pedicle (see FIG. 7). The entry 705 can be used to create an access 710 to the intervertebral disc space and as a bore 715 for subsequent pedicle screw fixation. An advantage of the intraosseous transpedicular entry 705 for both pedicle screw fixation and access to the disc space can include better pedicle screw performance and screw purchase. Various methods and devices can be used to form the pathways 705, 710 and 715.

[0054] FIGS. 8-10 show an embodiment in which the introduction and expansion of instrument 10 through entry 705 uses a cannula assembly 805. The cannula assembly 805 can be inserted through entry 705 formed in the pedicle of a vertebra that has an access 710 to the disc space as shown in FIG. 7. In an exemplary embodiment, a pair of intraosseous transpedicular entries 705 are formed on either side of the vertebral midline wherein each entry 705 also provides an access 710 into the disc space and uses a pair of cannula assemblies 805 positioned in entries 705 (see FIGS 8-10). 45088

[0055] In an embodiment, a guide frame can be used to align operative cannula systems 805 on a plane defined by the axis of pedicles on either side of the midline of target vertebra. Cannula guides can be positioned at a distance on either side of the vertebral midline and on an angle relative to each other and a neutral lateral axis of vertebra to allow for guided advancement of obturators and cannulas to a region of the accessory process on the vertebra. A pilot hole can be drilled to a depth determined by, for example, lateral imaging through the axis of the pedicles. A cannulated fitting can be advanced over the drill and screwed into the pedicle on either side of the midline and the drill bit removed. Instruments can be then passed through the pedicle fittings to perform a variety of procedures.

[0056] It may be necessary to reduce fractures in the treatment region and/or create a central void. Reduction instruments can include rod-like instruments that are deployed through the pedicle fittings, such as the devices described above or shown in the Figures. Some of these reduction instruments are stiff and straight, while others can have memory properties allowing for reduction of a collapsed portion of vertebra away from the midline of axis of the pedicles. Other instruments, such as those described above in FIGS. 11-13, can employ a scissor-jack mechanism of reduction. Distraction can be performed as well, for example, pursuant to the methods and devices described in U.S. Provisional Application Serial No. 61/068,048, filed March 3, 2008, entitled "Spool intervertebral distraction device and method", which is incorporated herein by reference in its entirety.

[0057] Instruments can be fed through a working channel 810 of the cannula 805. FIGS. 8 and 9 show the elongate element 20 of the instrument 10 (or 1310) ready for insertion through the working channel 810 of the cannula 805. The deformable element 215 (or 1315) is in a contracted configuration during insertion through the working channel 810 providing a relatively low profile for facilitating the positioning within the disc space. The rounded tapered portion 310 reduces the likelihood of damage to adjacent tissue during such positioning. In an embodiment, the outer diameter of the cannula 805 can be, for example, 5.5 mm such that the procedure and the entry 705 are minimally invasive. The inner diameter of the working channel of the cannula can be, for example, 5.0 mm or from 3.0 to 8.0 mm.

[0058] Subsequent to insertion within the disc space, the deformable element 215 (or 1315) can be mechanically-induced to create a force outward (see FIG. 10). The deformable element 215 (or 1315) is expanded, for example, by linearly displacing the inner rod 210 relative to the outer sleeve 205 as described above. The inner rod 210 can be displaced proximally, or the outer sleeve 205 can be displaced distally or both to effect linear movement along the longitudinal axis of the device. As a result, the deformable element 215 (or 1315) is outwardly deformed.

[0059] When in the expanded configuration, the leaflets 410 of the deformable element 215 form a number of radially extending projections. As discussed above, the configuration may define any number of radially extending projections, including a single or two or three or more projections. The direction of the radially extending projections is at least partially controlled by the configuration and placement of the leaflets 410. The direction of expansion can be unidirectional, bi-directional or multi-directional. In one embodiment, the leaflets 410 of the deformable element 215 are outwardly deformed along a multi-axial plane.

[0060] Once the deformable element 215 (or 1315) is in its outwardly expanded configuration, the deformable element 215 (or 1315) can be rotated to remove, abrade, resect or shear surrounding tissue near or adjacent the insertion region. The slots 405 and leaflets 410 permit the initial intrusion of soft tissue between the edges of the leaflets 410 into the slots 405 as the deformable element 215 gradually expands and allow subsequent egress of cut tissue as the deformable element 215 collapses. Rotation of the deformable element 215 (or 1315) including its expanded leaflets 410 can be such that the lateral or side edges remove surrounding soft tissue such as intervertebral disc material, cartilage, ligament, etc. Dissection and/or resection of soft tissue is created by rotating the device along its longitudinal axis and causing contact between the radially expanded deformable element 215 (or 1315) or leaflet edges (or edges of the cylindrical segment 1340) and the adjacent tissue into which it has been expanded. Alternatively, an articulating shaft such as a universal joint can be employed, such that rotation of the handle induces rotation of the deformable element 215 (or 1315) along a non-common axis.

[0061] Actuation of the device can occur using a variety of controls capable of imparting displacement of the inner rod past the outer sleeve. It should also be contemplated herein that expansion control and cutting controls can be separate systems. For example, the expansion can occur through a dial mechanism using threaded features at the proximal end of the device as described above and a separate control can be used to cause the expanded deformable element 215, 1315 to rotate and resect. For example, the instrument 10, 1310 can be rotated using the stationary handle 510 to effect rotation of the deformable element 215, 1315. It also should be contemplated that both expansion and cutting systems can be gradual.

[0062] Following reduction and/or resection procedures, the deformable element 215 can be reformed toward its initial insertion configuration by displacing the inner rod 210 relative to the outer sleeve 205. As a result, the leaflets 410 are inwardly deformed to allow for the removal of the instrument from the entry 705 and if using a cannula system 805 removed through the working channel 810.

[0063] Other instruments can be inserted through the access hole 705 or working channel 810 of the cannula system 805. In an embodiment, substantially short, straight distal segments having a diameter smaller than the cannula 805 can be placed on operating instruments (e.g. power burr, shaver, and resector) or implants and devices such as those described in U.S. Patent Application Serial No. 12/397,130; and U.S. Patent Publication Nos. 2008- 0234759; 2009-0036895; 2009-0062914 and 2009-0062852, which are incorporated herein by reference in their entirety.

[0064] In other embodiments, access to the disc space can involve the use of a curvilinear or non-cylindrical cannula system inserted through the pedicle, such as for example at L5-S1 or at L4-L5. For example, the iliac ala can present an impediment to the pedicle at the L5 or S1 level. In order to optimize the transpedicular approach, it can be advantageous to use a non-linear or non-cylindrical cannula such as at the lowest lumbar levels or the upper sacrum. A curvilinear or non-cylindrical cannula can avoid the iliac ala and improve the intradiscal convergence of a biportal transpedicular approach.

[0065] In this embodiment, the curvilinear or non-cylindrical cannula can be guided with an extracorporeal arcuate redirection guide to a posterior pedicle entry location that is common with the pedicle screw entry and pedicle axis. The radiused cannula path can generally extend from the posterior mid-pedicle axis superiorly and medially within the pedicle and then through the upper vertebral endplace and into the intervertebral disc space. Instruments used with a radiused cannula can have a flexible shaft, for example.

[0066] The curvilinear cannula can be generally concave relative to the midline or midsagittal plane of the body within the body, such as extending from the skin through the subcutaneous tissue, muscle and pedicle. The embodiment can also have a segment that is straight or radiused in the opposite direction, such as convex relative to the midline of the body, external to the body to avoid crowding of the surgeon's hands and instruments external to the body. An advantage of curvilinear cannulas is they can be larger than the linear cannulas. 9 045088

A curvilinear cannula can be, for example 6.5 mm or 7.5 mm compared to typically 5.5 mm linear cannulas used at more proximal lumbar or thoracic levels (e.g. L2, L3, and L4).

[0067] Following treatment of the region and the removal of the instrument(s), the cavity can be treated and/or filled. The region can be treated with therapeutic substances to promote healing such as, for example, osteoconductive, proliferative, and/or inductive material can be introduced into the remainder of the disc space for fusion. In another embodiment, a relatively elastic material such as polyurethane can be applied into the center of a partially evacuated intervertebral disc as a nuclear replacement. The cavity can also be filled, for example, with biocompatible filling material, bone cement, pelletized material (e.g. various forms of calcium sulfate), cortical allograft material, autograft, and other materials that polymerize or aggregate. Space created by the device can be used for subsequent insertion of bone cement ( such as, for example, Poly(methyl methacrylate) (PMMA)) or bone void filling material or an in situ expandable graft containment system (such as, for example, OPTIMESH, manufactured by Spineology) that can be inserted through a minimally invasive approach and conform to a defect structure.

[0068] While this specification contains many specifics, these should not be construed as limitations on the scope of the claims or of what can be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub- combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results.

[0069] Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

CLAIMSWhat is claimed is:
1. A device for treating a spinal structure, comprising: an elongate member comprising an outer sheath and an inner rod, the elongate member having a longitudinal axis; a deformable member coupled to a distal end portion of the elongate member, the deformable member comprising a plurality of leaflets each having at least one cutting edge, wherein the deformable member has an initial insertion configuration for placement adjacent a spinal structure and a radially expanded configuration; an actuator coupled to the inner rod of the elongate member, wherein the actuator gradually deforms the deformable member from the initial insertion configuration towards the radially expanded configuration upon linear foreshortening of the elongate member along the longitudinal axis; and a handle coupled to the elongate member and adapted to gradually rotate around the longitudinal axis of the elongate member such that when the deformable member is radially expanded the at least one cutting edge contacts tissue of the adjacent spinal structure.
2. The device of claim 1 , further comprising a collar surrounding the inner rod secured by a pin extending through an aperture in the collar and a channel near a distal end of the inner rod, wherein the pin is slidably positioned within the channel and the collar is disposed between a distal end of the outer sheath and a proximal end of the deformable member.
3. The device of claim 2, wherein the pin slides in the channel in the distal direction upon linear foreshortening of the elongate member along the longitudinal axis.
4. The device of claim 3, wherein the channel sets a distal limit to which the pin can slide and a maximum radial dimension to which the deformable member can radially expand.
5. The device of claim 1 , wherein the inner rod has a non-uniform outer dimension.
6. The device of claim 5, wherein the outer sheath is discontinuous along its circumference.
7. The device of claim 1 , wherein the elongate member is curvilinear.
8. The device of claim 1 , wherein the deformable member is comprised of a radiodense material.
9. The device of claim 1 , wherein the deformable member is interchangeably coupled to the distal end portion of the elongate member.
10. The device of claim 1 , wherein radial expansion of the deformable member exerts a displacing force when the device is at least partially positioned adjacent the spinal structure.
11. The device of claim 10, wherein the adjacent spinal structure comprises intervertebral disc tissue or a vertebral body.
12. The device of claim 1 , wherein rotation of the radially expanded deformable member resects, removes, abrades, shears or trims the adjacent spinal structure when the device is at least partially positioned adjacent the spinal structure.
13. The device of claim 12, wherein the adjacent spinal structure comprises intervertebral disc tissue.
14. The device of claim 1 , wherein radial expansion of the deformable member reduces the adjacent spinal structure when the device is at least partially positioned near the adjacent spinal structure.
15. The device of claim 14, wherein the adjacent spinal structure comprises a vertebral body.
16. The device of claim 1 , wherein the plurality of leaflets comprises two or more leaflets disposed generally opposite one another.
17. The device of claim 1 , wherein the at least one cutting edge of the plurality of leaflets has an arcuate geometry.
18. The device of claim 1 , wherein the at least one cutting edge of the plurality of leaflets has a non-uniform geometry.
19. The device of claim 1 , wherein the plurality of leaflets are biased to radially expand in a pre-determined direction that is away from the axis of linear foreshortening.
20. The device of claim 1 , wherein the actuator comprises a proximal portion threadably engaged with a knob and a distal portion coupled to the inner rod.
21. The device of claim 20, wherein the knob linearly displaces the actuator in a step-wise direction relative to the inner rod to radially expand the deformable member.
22. A method for treating a spinal structure, comprising: creating at least one intraosseous transpedicular pathway in a posterior pedicle of a vertebra; accessing an adjacent spinal structure through at least a portion of the pathway; introducing a device through the pathway to the adjacent spinal structure, the device comprising an elongate member having a longitudinal axis, an actuator coupled to a proximal end portion of the elongate member, a deformable member coupled to a distal end portion of the elongate member, the deformable member comprising a plurality of leaflets having at least one cutting edge, and a handle, wherein the device is introduced in an initial insertion configuration; and deforming the deformable member to bow outwardly and radially expand using the actuator to linearly foreshorten the elongate member along the longitudinal axis.
23. The method of claim 22, wherein the device comprises a collar surrounding the inner rod and secured by a pin extending through an aperture in the collar and a channel near a distal end of the inner rod, wherein the collar is disposed between a distal end of the outer sheath and a proximal end of the deformable member.
24. The method of claim 23, wherein the pin is adapted to slide within the channel in the distal direction upon liner foreshortening of the elongate member along the longitudinal axis.
25. The method of claim 24, wherein the channel sets a distal limit to which the pin can slide and a maximum radial dimension to which the deformable member can radially expand.
26. The method of claim 22, wherein the outward bowing of the deformable member displaces the adjacent spinal structure.
27. The method of claim 26, wherein the adjacent spinal structure comprises a vertebral body.
28. The method of claim 27, wherein displacing the vertebral body comprises performing vertebroplasty or reduction of vertebral compression factures.
29. The method of claim 26, wherein the adjacent spinal structure comprises an intervertebral disc.
30. The method of claim 22, further comprising rotating the handle.
31. The method of claim 30, wherein rotating the handle rotates the deformable member such that the at least one cutting edge contacts intervertebral disc tissue.
32. The method of claim 31 , wherein the at least one cutting edge resects, removes, abrades, shears or trims the intervertebral disc tissue as the deformable member rotates.
33. The method of claim 22, wherein introducing a device comprises positioning a guide for advancement of a cannula through at least a portion of the pathway and inserting the device through a working channel of the cannula.
34. The method of claim 33, wherein the cannula is curvilinear.
35. The method of claim 34, wherein the guide comprises an arcuate redirection guide.
36. The method of claim 30, wherein the steps of deforming the deformable member and rotating the handle are performed gradually.
37. The method of claim 36, wherein the steps of deforming the deformable member and rotating the handle are performed simultaneously.
38. The method of claim 22, further comprising treating a cavity created with the device, wherein the treatment comprises introducing a material selected from the group consisting of osteoconductive material, proliferative material, inductive material, elastic material, nuclear replacing material, biocompatible filling material, bone cement, palletized material, calcium sulfate hemihydrate, cortical allograft material, polymerizing material, aggregating material, structural implants, plugs, poly(methyl methacrylate), bone void filling material, and an expandable graft containment system.
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