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1. WO2007146928 - IMPLANT SYSTEM AND METHOD TO TREAT DEGENERATIVE DISORDERS OF THE SPINE

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[ EN ]

IMPLANT SYSTEM AND METHOD TO
TREAT OEGEiNERATlVE DISORDERS OF THE SPINE

CLAIM OF PRIORITY
føøølj This application claims benefit to U S Provisional Application No 60/801,871. filed June 14, 2006, entitled "Implant Positioned Between the Lamina to Treat Degenerative Disorders of the Spine." U.S. Patent Application No 1 1/761 ,006, filed June 11, 2007, entitled "Implant System and Method to Treat Degenerative Orders of the Spine," U.S. Patent Application No 1 1/761, 100, filed June 11, 2007, entitled 'Implant System and Method to Treat Degenerative Disorders of the Spine," and U.S. Patent Application No. 1 1 /76Ll 16. filed June I L 2007, entitled "Implant System and Method to Treat Degenerative Disorders of the Spine." all of which are incorporated herein by reference and in their entireties.

BACKGROl ND OF LNVEMION
[0002} The most dynamic segment of orthopedic and neurosurgical medical practice over the past decade has been spinal devices designed to fuse the spine to treat a broad range of degenerative spinal disorders. Back pain is a significant clinical problem and the annual costs to treat it both surgically and medically, is estimated to be over $2 billion. Motion preserving devices Io treat back and extremity pain have, however, created a treatment alternative to fusion for degenerative disc-disease These devices offer the possibility of eliminating the long term clinical consequences of fusing the spine that is associated with accelerated degenerative changes at adjacent disc levels.
|0003| While total disc replacement is seen as a major advance over fusion, the procedure to implant the devices in the lumbar spine requires a major operation via an anterior approach, subjecting patients to the risk of significant complications These include dislodgement of the device, which may damage the great vessels, and significant scarring as a consequence of the surgical procedure itself, which makes revision surgery difficult and potentially dangerous. Thus, there are advantages to spinal implants that can be inserted from a posterior approach, a technique with which spine surgeons are much more experienced, l he posterior surgical approach also has the benefit of being able to directly address all pathologies that may be impinging the neural elements, which is not possible from an anterior approach Motion preserving spina! devices that can be implanted with a minimally invasive, posterior procedure offer the benefit of less surgical trauma and faster patient recovery and also offer cost savings to payers with patients staying fewer days in the hospital.
{0004] Motion preserving devices placed posteriorly typically either rely on the spinous processes to support the implant or require pedicle screws to be inserted. However, spinous processes are not load bearing structures and are not rigid. In a population of patients with back pain, the laminae offer a much stronger structure to position an implant, since they consist of significantly stronger bone, and the laminae are also closer to the spine's axis of rotation. Pedicle screws have several disadvantages when used as attachments for motion preservation devices. The procedure to implant them is considered major surgery requiring a wide exposure. The screws are also subject to significant loads and screw loosening is a known consequence over time in these cases. Removing the screws and fusing the spine requires major revision surgery.

BRIEF DESCRIPTION OF THE DRAWINGS
{0005] Fig. Hs a perspective view of an embodiment of the dynamic spine stabilization, motion preservation implant of the invention.
[0006} Fig. 2 is a perspective view of another embodiment of the dynamic spine stabilization, motion preservation implant with pedicle screws of the invention.
|0007J Fig. 3 is a side view of an embodiment of a hook of the invention of the embodiment of Fig 2.
|000S| Fig. 4 is a top view of the embodiment of the hook of the embodiment of the invention of Fig. 3.
{O0O9J Fig. S is an end view of the embodiment of the hook of the embodiment of the invention of Fig. 3.
føOtOJ Fig. 6 is a bottom view of the embodiment of the hook of the embodiment of the invention of Fig. 3.
|0011 J Fig. 7 is a side perspective view of the embodiment of the hook of the embodiment of the invention of Fig. 3.
JOOO] Fig. S is a side perspective view of another embodiment of the hook of the invention.

fθOlSJ Fig, 9 is a top view of the embodiment of the invention of Fig. 8.
føøl 4 j Fig 10 is a side vi ew of the embodiment of the inveiiti on of Fig. 8.
|OOI5| Fig. 1 Hs a side partially sectioned view of another embodiment of an implant of the invention.
|0016] Fig. 12 is a side view of an embodiment of a hook of the embodiment of the invention of Fig 1 1.
|0017| Fig. 13 is a perspective view of a hook with barbs of an embodiment of the invention Io be used with the embodiment of the invention of Fig. I I.
{OQl 8] Fig. 14 is a side vi ew of the embodiment of the hook of the inventi on of Fig. 13. |0019j Fig. 15 is a side view of another embodiment of the hook of the invention
|0020 j Fig. 16 is a side view of the another embodiment of the hook of the invention of

Fig. 15 in a different orientation.
j 00211 Figs. 17A, 17B are scherøatica! top views of the embodiment of Fig. 15.
{0022] Figs. 18 A, 18B are side views of another embodiment of the hook of the invention.
|0023| Fig. 19 depicts an embodiment of the method of implantation of the invention

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024} In one embodiment of the present invention, an implant is provided that can be placed between the lamina through a posterior, minimally invasive surgical technique and is designed to treat degenerative disorders of the spine. Degenerative disc disease results from the natural process of aging and ultimately affects all structures of the vertebral motion segment. The degenerative process causes loads that are normally borne by the intervertebral disc to be transferred to the articular facet joints, ligaments and other soft tissues of the spine. |0025| The benefits of this implant are: The articular facets provide an excellent structure to which to attach an implant. They consist of very strong cortical bone, the strongest in the lumbar vertebra There are no major nerves or vessels in the area approximate to the lateral aspect of facets, making them also a very safe point of attachment.
|0026| Attached to hooks, a crosslink can be positioned as far anterior as is possible without actually impinging on the spinal canal.
{0027] The implant can be inserted through two small incisions on either side of the midline, preserving the spinal ligament structures, including the supraspinous ligament and the interspinoυs ligament and permitting the implant to placed using a minimally invasive procedure
|0028| An embodiment of the clamp implant system 20 of the invention is depicted in Fig 1 Implant system 20 provides for dynamic stabilization and motion preservation of the spine Implant system 20 includes anchor systems 22, horizontal rods 24, 26 and vertical connector system 28. Preferably, the anchor systems 22 and the vertical connector system 28 are made of titanium although stainless steel can also be used The horizontal rods 24, 26 are preferably made of PEEK or other similar polymer as described below or are made of a super elastic material such as Nitinol which is an alloy of titanium and nickel Other biocompatible materials can he used and be within the spirit and scope of the invention. Preferably, the vertical system 28 is rigid while the horizontal rods 24, 26 are flexible. Such a system 20 would accordingly have the horizontal rods made of PEEK or a similar polymer or a super elastic material while the vertical system is comprised of titanium or stainless steel With such a system, the load that the spine places on the system would be absorbed by the horizontal rods causing the horizontal rods to flex while the vertical system remains rigid.

|0029} Fig. 2 includes another embodiment of the clamp implant system 20 which has an additional provision for pedicle screws 38 to assist in holding the system 20 to the spine Elements of the embodiment of Figs S, 2 that are the same have similar numerical references fOOSOJ Generally, the clamping implant system 20 (Figs. 1 , 2) includes opposing clamps 30, 32 that can wrap around the facets (from posterior to anterior) and hook or angle under the facets to assist in maintaining the clamps in position and resist pull-out forces Accordingly, the clamps 30, 32 hook or angle around the outside of the facets and are held in place by the design of the clamps 30, 32. The system 20 also includes opposing clamps 34, 36 which are the similar to opposing clamps 30. 32 The clamps 30. 32, 34, 36 have set screws 40 as explained below to lock in the horizontal rods 24, 26
|00311 The opposing clamps 30, 32. and opposing clamps 34. 36 as can be seen in Figs. 3, 4, 5, 6.. 7, include a head 42 and a foot or hook 44. Preferably, the clamps are of one piece construction, however, as described below, the clamps can be of several piece construction with the added advantage of more degrees of freedom in implanting the clamps in the patient. The clamps 30. 32, 34, 36 include a threaded set screw bore 46 for receiving the set screw 40 and a horizontal rod bore 48 for receiving the horizontal rods 24. 26. The head 42 also includes a pedicle screw bore 50 which is preferably unthreaded and which can receive the pedicle screw 38 The bore 50 is angled in order to guide the pedicle screw into the pedicle of the spine. The head 42, accordingly, accepts in this embodiment a horizontal rod that is transversely mounted in the head and the top mounted set screw 40. As will be discussed below, the head 42 can include a split retainer, such as a split ball retainer that lias a central bore for accepting the horizontal rod, and, which split retainer can be compressed by the set screw to retain the horizontal rod in the head of the clamp. The foot 44, points like a finger away from the head and in Fig 3 looks much like an index finger of a right hand of a human extending from the rest of the hand, with the fingers and thumb of the rest of the hand folded down into the palm of the human hand Stated another way there is an L-shaped junction between the head 42 and the foot or hook 44. As is evident from the figures, there is in this preferred embodiment, a continuous transition from the head 42 to the foot or hook 44. The inner surface of the foot 44 can be comprised of a textured surface to provide for bony ingrowth of the spine bone into the foot 44. Also the inner surface can be coated with bone growth inducing materials such as bone morphogenetϊc proteins or BMPs. The inner surface of the foot 44 in this preferred embodiment, is comprised of a compound surface that can accommodate the anatomical shape of the facets in order to secure the clamps about the facets. In this embodiment the foot 44 has a first radius of curvature 52 (Fig 5} which defines the first curve of the foot along the length of the foot. The foot 44 also includes a second radius of curvature 54 (Fig 6) which defines the second curve of the foot across the width of the foot with the first curve and the second curve in this embodiment being about perpendicular to each other. The first curve runs about vertically and the second curve runs about horizontally In this embodiment the first radius of curvature is about 0.625 inches and the second radius of curvature is about 0 785 inches These curves allow the foot or hook 44 to optimally conform to the anatomical shape of the outside of the facet with a contour for maximum contact area In this preferred embodiment, the clamps 30, 32, 34, 36 have about up to 40 degrees of adjustment upon implantation relative to the coronal orientation of the spine and up to about 10 degrees of adjustment upon implantation relative to the sagittal orientation of the spine.
|0032| As can be seen in Figs 3, 5, 6, spikes 56 extend from the inner surface of the foot or hook 44 of the clamps 30, 32, 34, 30. These spikes 56 are used to also secure the foot or hook 44 to the outer surface of the facets. The tips of the spikes 56 are designed to cut and penetrate the facet bone and not to compress the facet bone. The spikes have flat surfaces 58 that increase lateral resistance to lateral movement of the clamps 30, 32, 34, 36, and, thus, assist in preventing the clamps from working themselves out of engagement with the facets.

The spines 58 are arranged down the length of the foot 44 and across the base of the foot 44, where the foot 44 transitions to the head 42. As depicted, the spikes 56 are arrayed in the foot in order to obtain optimal stability of the clamp as secured to the facets. The smooth transition between the head 42 and the foot 44 allows for. in this embodiment, continuous sagittal adjustment. This additionally allows for optimal positioning and orientation of the horizontal rods 24, 26 upon implantation of the system 20. The shape and radii of the foot and the transition from the head to the foot allow the clamp to match the anatomical variations in the junction between the transverse process and articular processes of the spine.
J0033] Figs. 8, 9, 10, depict alternative embodiments of the clamps 30, 32, 34, 36, which have lamina articular process hooks 60, 62 which have a hook element 64, 66, respectively, that is curved to fit around the lamina and assist in holding the clamp in piace in the spine. The hooks 60, 62 include adjustable arms 68, 70 that can adjust to the size of the lamina of the spine. As is evident from Figs. 8, 9, 10, each arm 68, 70 includes an elongate slot such as slot 72 with a set screw such as set screw 74, provided through said slot 72. The set screw 74 is mounted in a threaded bore in the clamp 30 and the arm 68 can slide relative to the rest of the clamp to adjust to the spine and then the arm 68 can be locked into position by the set screw It is evident from the depiction that clamp 30 in Figs. 8, 9, 10, has a different head than the head depicted in the prior embodiment of the clamp 30. In order to accommodate the laminar hooks 60, 62, the embodiments of the clamp 30 in Figs. 1 - 7 can be modified in a number of ways. For example, the top of the head of the clamp in these figures can be widened to accept the arm 68 and the set screw 74, and, thus, both the set screw 40 and the set screw 74, can be tightened from the top of the head of the damp. Alternatively, the slot 72 of the arm can be rotated by about ninety degrees so that the set screw can lock the arm to the clamp along the outside of the clamp, opposite to the surface of the clamp that has the spines and conforms to the surface of the facet. It is also to be understood that the clamps 30, as they appear in Figs. 8, 9, 10, can be used by themselves to repair fractures of the pars iπteraiticularis on the lamina of the spine.
|0034| The horizontal rods 24, 26 can have variable lengths and diameters in order accommodate the shape of the spine. Preferably, the diameters of the horizontal rods 24, 26 can be selected to adjust the dynamic stabilization, motion preservation feature afforded by these embodiments, larger diameter, generally, will provide for a suffer system while smaller diameters will provide for a less stiff system. For the same diameter, rods made of PEEK will provide for a stifier system than rods made of a super elastic material. Also rods made of stainless steel will be stiffer than rods made of titanium, PEEK rods will be less stiff than rods made of titanium or stainless steel Accordingly, the rods can be selected to give the degree of flex desired, and, thus, the degree of dynamic stabilization desired in response to dynamic loads placed on the system 20 by the spine in motion. It is to be understood that the horizontal rods can also be bent or bowed out in order to accommodate the anatomical structures of the spine.
|00351 The vertical connector system 28 in Figs. 1, 2, connect adjacent horizontal rods 24, 26, which horizontal rods are associated with different vertebral levels. In this embodiment the vertical connector system 28 is about U-shaped. The vertical connector system 28 includes an upper half connector 76 joined to a lower half connector 78, along the split line 86, by a locking screw 80. With the upper connector and the lower connector joined, the system 28 defines a first horizontal rod capture bore 82 and a second horizontal rod capture bore 84 The vertical connector systems 28 are curved at the midpoint or apex of the curve in order to accommodate, and, thus, preserve the spinous processes and the associated ligaments. In this particular embodiment, the locking screw 80 is located at the midpoint and is used to lock the system 28 about the first and second horizontal rods 24, 26 It is to be appreciated that another vertical connector system 28 can be used with the system 20 in order to impart additional stiffness. If two systems 28 were used, one would be closer to the first clamp 30 (also clamp 34) and the other would be closer to the second clamp 32 (also clamp 36) in order to accommodate the spinous processes and ligament structures of the spine. If two systems 28 were used, the set screws 80 and the midpoint or apex of each system would be closer to the respective clamps in order to define a large opening between the two vertical connector systems 20 to accommodate the spinous processes and associated ligaments. If desired, the vertical connector system can be made of a less stiff biocompatible material as discussed herein, should additional flexibility be desired.
(0036] Referring to Figs 1 1 , 12, another embodiment of the present invention is an implant, generally denoted as 100, with a first hook 102, a second hook 104 and a cross-link or horizontal rod 106 coupled to the first and second hooks 102 and 104. The first and second hooks 102 and 104 have geometries that conform to a lateral border of a superior articular facet.
(0037] In various embodiments, the implant (i) engages the laminae to stabilize the spine in a dynamic manner, and (ii) can be made stiff enough to rigidly stabilize the spine as an aid to a fusion.

f0038| In one embodiment, the first and second hooks have radii to provide conformance with the spine. As discussed below, the first and second hooks 102 and 104 can be symmetrical in a sagittal orientation and free to rotate around a coronal axis The first and second hooks 102 and 104, can provide an ability to adjust to, and be affixed to, the articular facets. In one embodiment, the first and second hooks 102 and 104 include at least one member to engage with the articular facet. This member can be a fin, stud, spike, and the like, as discussed above with respect to other embodiments.
|0039J Further as seen in Figs. I I , 12, the hooks include a ventral or lower hooked section 108 and an dorsal or upper head section 1 10. The hooked section 108 can conform to the spine as described herein and the head section 1 10 can mount the cross-link or horizontal rod 106. The head sections S 10 can include a top bore 1 S 2 that is threaded and can accept a set screw to lock the horizontal rod 106 in place. The head section 1 i0 also includes either (1) a recess 1 14 that can receive an end of the horizontal rod 100 such that the set screw can lock the rod 106 in place, or (2) a bore 1 16 through which the rod 106 can be received so that the spacing between the hooks !02, 104 can be adjusted. Once the rod 106 is received in the bore i 16 and the spacing of the hooks 102, 104 is adjusted by sliding the hook 102 on the rod 106, a set screw can be used to lock the rod 106 in place. It is to be understood, that procedural!}/ and preferably, the hooks 102, 104 are placed adjacent to the facets and the length between the hooks is adjusted prior to the tightening of the set screws to lock the rod 106 and the hooks 102. 106 together. Alternatively, the rod 106 can be telescoping such that a first portion ! 18 of the rod S 06 can slide into a second portion S 20 of the rod S 06 in order to adjust the length of the rod 106. If desired, an additional set screw can be mounted on the second portion 120 of the rod 106 to lock the first portion to the second portion of the rod.
|0040| As illustrated in Figs 13, 14, 15. 16, 17A, 17B the first and second hooks such as hook 102 can have a ventral or lower section 108 and dorsal or upper sections 1 10 that can move and in this embodiment, rotate relative to each other. The ventral or lower hooked sections 108 has a freedom of motion about an axiai plane to allow for variations in anatomy of the articular facet. The dorsal or upper section 1 10 accepts the horizontal rod 106. The dorsal or upper section 1 10, as previously discussed, includes a recess or bore to accept the horizontal rod 106 in this embodiment, the horizontal rod 106 rests in the saddle or head or upper portion ! 10 and a set screw locks the horizontal rod in place in the head
{00411 As depicted in Figs 15, 16, 17A, 17B, the lower hooked portion 108 can rotate relative to the upper head portion 110. The rotation occurs at split line 122 Preferably, the upper portion J 10 can snap into the lower portion 108 and be captured under a lip of the cylindrical recess of the lower portion 108 Thus, the upper portion 1 10 can rotate in the recess 122 of the lower portion 108 at the 4JpHt line 522 If desired the rotation can be limited h> a limit rod 126 that is mounted on the lower portion 108 and projects through the cylindrical recess 122 The uppet portion includes an enlatged bore 128 thtough which the limit rod 126 is received, when the upper poπion is assembled with the lowei portion of the hook 102 In a preferred embodiment, the limit rod allows the upper portion of the hook 102 to rotate about 15 degrees on each side of a central axis, for a total of about 30 degrees of rotation it is to be understood that 360 degrees of rotation is possible with the limit rod 126 remo\ ed, and also that changes to the size of the bore 128 can be made to adjust the degree of rotation of the upper portion to the lower portion or the hook 102 According! \ , the first and second hooks 102 and 104 illustrated in Figs 15, 16 are adjustable and can be re-adjusted after the hooks 102 and 104 are initialK implanted
{00421 Jft the embodiment of Hgs 18A, S 8B, the horizontal rod 106 is configured to be fixed with compression applied by a set screw received though bore 1 12 in head 1 10 1 he set screw can fix an orientation of the ventral or upper section 108 of the hooks 102 and horizontal rod 106. as well as, lock the upper portion of the hook to the lower portion 108 at the same time in this embodiment, the horizontal rod 106 can be received in a compression block 130 that is received in the bore 1 12 Generally, the compression block is cylindrical and can be comprised of two pieces which mate with facing recesses that can receke the horizontal rod 106 Alternat ely, the compression block can be a one piece construction with a slit In eithei embodiment, the set screw, when turned down in the bore 112, causes the compression block 130 to compress about, and without causing damage to, the horizontal rod 106 to lock the rod in place
|0043j In one embodiment the horizontal rod 106 has a flat surface that conforms to a laminar anatoro> or a contoured surface to match the laminar anatomy
{0044 j In another embodiment of the present itnenϋon, the implant 100 includes an artificial ligament attached to the horizontal rod 106 The artificial ligament can be looped around the superior spinous process and then re-attached to the horizontal rod 106 The artificial ligament provides a limit to flexion and increases rigidit\ of the implant The artificial ligament can be made of a biocompatible material
{00451 ^n another embodiment of the present invention, an implant assembly is provided that lias first and second implants 100 The fust and second implants !00 can be coupled by at least one vertically running rod configured to provide rigid stability as an aid in fusing the spine.
|0046| It is to be understood that the various features, designs and functions of the various embodiments can be selected for and or combined in other embodiments as is advantageous. J0047J With respect to the method of implantation (Tigs. 19), the hooks can be placed adjacent to the facets, and then the position of the horizontal rod relative to the hooks can be adjusted. The hooks can be pressed into the bone and the set screws can be tightened to hold the hooks and horizontal rod in place. With two such configurations in the spine, the configurations can be connected with vertical rods and the like. Alternatively, the implant, including the hooks and the horizontal rod loosely coupled together, can be inserted as an assembly and then once positioned, the set screws can be tightened to lock the system 100 in place in the spine.
J0Q48J Materials for use with the implant include the following:
J0049] As indicated above, the implant can be made of titanium, stainless steel, super elastic materi als and/or polymers such as PEEK.
|0050} In addition to Nitinol or nickel-titanium (NiTi) other super elastic materials include copper-zinc-aluminum and copper-aluminum-nickel. However for biocompatibility the nickel -titanium is the preferred material.
f0051J Other suitable material include, by way of example, only polyetheretherketone (PEEK), poly etherketoneket one (PEKK), poiyetherketone (PKK), polyetherketoneether-ketoneketone (PEKEKK), and polyeiheretherketoneketone (PEEKK). Still, more specifically, the material can be PEEK 450G, which is an unfilled PEEK approved for medical implantation available from Victrox of Lancashire, Great Britain. (Victrex is located at wwvv.matweb.com or see Boedeker www boedeker.com). Other sources of this material include Gharda located in Panoli, India (www.ghardapolymers.com).
|0052| Preferably, the horizontal rods are made of PEEK or a similar polymer or a super elastic material which materials are flexible, or the rods are made of another flexible material and the anchors and the vertical systems are made of titanium or stainless steel which are stiff or made of another stiff material.
|0053} Further, it should be apparent to those skilled in the art that various changes in form and details of the invention as shown and described may be made. It is intended that such changes be included within the spirit and scope of the claims appended hereto The foregoing description of preferred embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.