WO2007146928A2 - Implant system and method to treat degenerative disorders of the spine - Google Patents
Implant system and method to treat degenerative disorders of the spine Download PDFInfo
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- WO2007146928A2 WO2007146928A2 PCT/US2007/070981 US2007070981W WO2007146928A2 WO 2007146928 A2 WO2007146928 A2 WO 2007146928A2 US 2007070981 W US2007070981 W US 2007070981W WO 2007146928 A2 WO2007146928 A2 WO 2007146928A2
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- hook
- implant
- spine
- horizontal rod
- vertebra
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7056—Hooks with specially-designed bone-contacting part
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7047—Clamps comprising opposed elements which grasp one vertebra between them
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
- A61B17/7052—Connectors, not bearing on the vertebrae, for linking longitudinal elements together of variable angle or length
Definitions
- Motion preserving devices placed posteriorly typically either rely on the spinous processes to support the implant or require pedicle screws to be inserted.
- spinous processes are not load bearing structures and are not rigid.
- 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.
- Fig. H a perspective view of an embodiment of the dynamic spine stabilization, motion preservation implant of the invention.
- Fig. 2 is a perspective view of another embodiment of the dynamic spine stabilization, motion preservation implant with pedicle screws of the invention.
- FIG. 3 is a side view of an embodiment of a hook of the invention of the embodiment of Fig 2.
- 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.
- f ⁇ OtOJ 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.
- Fig. S is a side perspective view of another embodiment of the hook of the invention.
- f ⁇ OlSJ Fig, 9 is a top view of the embodiment of the invention of Fig. 8.
- f ⁇ l 4 j Fig 10 is a side vi ew of the embodiment of the inveiiti on of Fig. 8.
- FIG. 1 Hs a side partially sectioned view of another embodiment of an implant of the invention.
- Fig. 12 is a side view of an embodiment of a hook of the embodiment of the invention of Fig 1 1.
- 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.
- 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
- FIG. 15 in a different orientation.
- j 00211 Figs. 17A, 17B are scher ⁇ atica! top views of the embodiment of Fig. 15.
- FIGs. 18 A, 18B are side views of another embodiment of the hook of the invention.
- FIG. 19 depicts an embodiment of the method of implantation of the 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.
- the benefits of this implant are:
- the articular facets provide an excellent structure to which to attach an implant.
- a crosslink can be positioned as far anterior as is possible without actually impinging on the spinal canal.
- 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 interspino ⁇ s ligament and permitting the implant to placed using a minimally invasive procedure
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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 morphogenet ⁇ c 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.
- 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
- the first radius of curvature is about 0.625 inches and the second radius of curvature is about 0 785 inches
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the clamps 30, as they appear in Figs. 8, 9, 10 can be used by themselves to repair fractures of the pars i ⁇ teraiticularis on the lamina of the spine.
- the horizontal rods 24, 26 can have variable lengths and diameters in order accommodate the shape of the spine.
- 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.
- rods made of PEEK will provide for a stifier system than rods made of a super elastic material.
- 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.
- the vertical connector system 28 in Figs. 1, 2, connect adjacent horizontal rods 24, 26, which horizontal rods are associated with different vertebral levels.
- 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.
- 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
- 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.
- the vertical connector system can be made of a less stiff biocompatible material as discussed herein, should additional flexibility be desired.
- FIG. 1 1 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.
- the implant 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.
- the first and second hooks have radii to provide conformance with the spine.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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
- 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
- the upper portion 1 10 can rotate in the recess 122 of the lower portion 108 at the 4 JpHt line 522
- 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 po ⁇ ion is assembled with the lowei portion of the hook 102
- 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 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.
- the horizontal rod 106 can be received in a compression block 130 that is received in the bore 1 12
- the compression block is cylindrical and can be comprised of two pieces which mate with facing recesses that can receke the horizontal rod 106
- the compression block can be a one piece construction with a slit
- 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
- 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
- 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
- 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.
- 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.
- Nitinol or nickel-titanium other super elastic materials include copper-zinc-aluminum and copper-aluminum-nickel.
- 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).
- 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).
- 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.
Abstract
An implant has a first hook and a second hook. A connector is coupled to the first and second hooks. The implant is adapted in a preferred embodiment to hook and look onto a spine.
Description
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.
Claims
What is claimed ϊy
1. A n imp] ant corapri si ng a first hook adapted to be hooked onto a first portion of a vertebra; a second hook adapted to be hooked onto a second portion of said same vertebra. a connector coupled to the first and second hooks: and a first lock associated with the first hook and a second lock associated with the second hook, wherein the position of the first hook and the second hook relative to the rod can be adjusted and then locked in place relative to said same vertebra.
2. The implant of claim 1 , wherein the first and second hooks have geometries that conform to a lateral border of a superior articular.
3. The implant of claim 1 , wherein the first and second hooks have several different radii to ensure the hooks match anatomy variations in the articular facets.
4. The implant of claim 1, wherein the first and second hooks have several different radii to ensure the hooks match anatomy variations in the articular facets wherein said first radius is about 0.625 inches and the second radius is about 0.785 inches and the first radius describes a curve in a first plane and the second radius describes a curve that is in a second plane and wherein said first plane is about perpendicular to the second plane
5. 'The implant of claim 1, wherein the first and second hooks have an upper portion that accepts the connector, which upper portion can move relative to a lower portion that is adapted to engage bone of a patient.
6. 'The implant of claim 1, wherein the first and second hooks have an upper portion that accepts the connector, which upper portion can move relative to a Sower portion that is adapted to engage bone of a patient and wherein said first lock can Sock the connector and the upper and lower portion of the first hook together and the second lock can lock the connector and the upper and the lower portion of the second hook together.
7 The implant of claim 1, wherein the first and second hooks have an upper portion that accepts the connector, which upper portion can move relative to a lower portion that is adapted to engage bone of a patient and wherein said first lock can lock the connector and the upper portion of the first hook together and the second lock can lock the connector and the upper portion of the second hook together.
8. The implant of claim 1, wherein the first and second hooks have an upper portion that accepts the connector, which upper portion can rotate relative to a lower portion that is adapted to engage bone of a patient
9. The implant of claim !.. wherein the connector is configured to be fixed with compression applied by a set screw to the first hook and to the second hook,
10. The implant of claim 1 wherein at least one of said first and second hooks includes at least one of one or more spikes, fins, and studs extending therefrom that can pierce the bone of a patient when the hooks implanted in a patient
1 i . The implant of claim S 0 wherein the at least one of one or more spikes, fins and studs have a fiat surface to enable the spike, fin or stud to penetrate the bone being resistant to being worked out of position with the motion of the spine.
12. The implant of claim 1 , wherein the first and second hooks are configured to provide an ability to adjust to and be affixed to the articular facets.
13. The implant of claim 1, wherein the first and second hooks include at least one member adapted to engage with the articular facet.
14 The implant of claim 1, wherein the connector is configured to be inserted to preserve the supraspinous and interspinous ligaments and the spinous processes.
15. The implant of claim L wherein the connector has a fiat surface that conforms to a laminar anatomy or a contoured surface to match the laminar anatomy.
16 The implant of claim J , wherein at least one of the first and second hooks of the implant includes an arm with another hook adapted to engages the laminae
17 The implant of claim 1 , wherein the first and second hooks include a textured inner suf face to facilitate bonej mgiowth
18 The implant of claim 1 wherein said connector is a horizontal rod that is adapted to be about parallel with a vertebral body
10 The implant of claim 1 wherein said connector is a horizontal rod that is flexible
20 The implant of claim ! wherein said connector is a horizontal rod comprised of PEEK
21 The implant of claim ! wherein said connector is a rod and said first hook includes a first bore that received said rod and second hook includes a second bore that recehes said rod with said first hook facing said second hook and said first lock can look said first hook onto said iod and said second lock can lock said second hook on said rod
22 The implant of claim 1 wherein said first hook includes a first pedicle screw bore and a first pedicle screw that can be provided there said first pedicle screw bore and said second hook includes a second pedicle scsevv bore and a second pedicle sciew ihat can be pscn ided through said second pedicle screw bore
23 An implant, comprising a first hook, a second hook, each of the first and second hooks having a geometry that conforms to a lateral border of a superior articular facet, and a connectυi coupled to the first and second hooks
24 The implant of claim 23. wherein the first and second hooks have an upper portion that accepts the connector, which upper portion can move relative to a lower portion that is adapted to engage bone of a patient
25 1 he implant of daim 24, wherein at least one of said first and second hooks includes at least one of one or more spikes, fins, studs extending therefrom that can pierce the bone of a patient when the hooks implanted in a patient
2b 1 he implant of claim 23, wherein the at least one of one or more spikes, fins and studs have a fiat surface to enable the spike, fin or stud to penetrate the bone being resistant to being woiked out of position with the motion of the spine
27 The implant of claim 23, wherein at least one of the first and second hooks of the implant includes an arm w ith another hook adapted to engages the laminae
28 An implant adapted to be implanted in a veπebra, the implant comprising a first hook that has a first hooked end and at least a first spike spaced from the first hooked end a second hook that has a second hooked end and at least a second spike spaced from the second hooked end, each of the first and second hooks having a geometry that conforms to a lateral border of a superior articular facet with each of said first and second hooked ends adapted to hook under the respective superior articular facet, and a connector coupled to the fust and second hooks, which eonneetoi is a flexible horizontal rod
29 The implant of claim 28 including
a first Sock to lock said first hook to said horizontal rod and a second lock to lock said second hook to said horizontal rod with said first hook facing said second hook
30. The implant of claim 28, wherein the first hook has a first upper portion that accepts the horizontal rod, which first upper portion can move relative to a first lower portion that has said first spike that is adapted to engage the bone of a patient and wherein said second hook has a second tipper portion that accepts the horizontal rod, which second upper portion can move relative to a second lower portion that has said second spike that is adapted to engage the bone of a patient.
3 1 . An imp] ant compri si ng: a first bone anchor adapted to be attached to a first portion of a vertebra; a second bond anchor adapted to be attached to a second portion of the same vertebra; a flexible horizontal rod connected to the first bone anchor through a first head of the first bone anchor said flexible rod connected through a second head of the second bone anchor; and said first bone anchor including a first upper cradle and a first lower cradle to capture the flexible horizontal rod between the first upper cradle and the first lower cradle and the second bone anchor includes a second upper cradle and a second lower cradle to capture the flexible horizontal rod between the second upper cradle and the second lower cradle.
32. The implant of claim 31 including a first lock to lock the first bone anchor to the horizontal rod and a second lock to lock the second bone anchor to the horizontal rod and wherein the locking of the first and second bone anchors to the horizontal rod with the first and second bone anchors positioned relative to one vertebra locks the implant to the one vertebra.
33 The implant of claim 31 wherein said first bone anchor includes said first head which is an upper portion that can accept the flexible horizontal rod and said first bone anchor includes a lower portion extending from said upper portion which lower portion is adapted to engage bone.
34 The implant of claim 33 wherein the one of the upper portion and the lower portion of the first bone anchor can move relative to the other of the upper portion and the lower portion of the first bone anchor.
35 The implant of claim 3 i wherein said horizontal rod is adapted to be about parallel to the vertebra with the first anchor secured to a first portion of the vertebra and the second anchor secured to a second portion of the vertebra located distal Iy from the first portion of the vertebra.
36 The implant of claim 31 wherein said horizontal rod is made of PB.EK.
37. An imp] ant compri si ng- a first bone anchor adapted to be attached to a first portion of a vertebra; a second bond anchor adapted to be attached to a second portion of the same vertebra; a flexible horizontal rod connected to the first bone anchor and the second bone anchor; a third bone anchor adapted to be attached to a first portion of another vertebra; a fourth bone anchor adapted to be attached to a second portion of the same another vertebra; another flexible horizontal rod connected to the third bone anchor and the fourth bone anchor; a rigid vertical rod connected between the first horizontal rod and the second horizontal rod.
38. The implant of claim 37 wherein said rigid vertical rod is not meant to flex, while at feast of the first and second horizontal rods is meant to absorb and be deflected with respect to at ieast in part the motion of the spine,
39. The implant of claim 37 wherein said rigid vertical rod is curved so as to be adapted to avoid a spinous process of a spine which is located between the flexible horizontal rod and the another flexible horizontal rod.
40 The implant of claim 3C> including another rigid vertical rod that is curved so as to be adapted to a\oid a spinous process of a spine which is located between the flexible horizontal rod and the another flexible hoπ/ontal rod, with the curved rigid rod and said another curved rigid vertical rod together defining at least part of a circle
41 An i ui pi am comprising a first bone anchor adapted to be attached to a first portion of a vertebra, a second bond anchor adapted to be attached to a second portion of the same \ ertebia and a flexible horizontal rod connected to the first bone anchoi directly through a fϊr>t head of the first bone anchor said flexible rod connected directly through a second head of the second bone anchor, which flexible horizontal rod flexes to carry and accommodate a load placed on the implant by the spine
42 1 he implant of claim 41 including said first bone anchor including a first upper cradle and a first lower cradle to capture the flexible horizontal rod between the fust upper cradle and the first lower cradle and the second bone anchor includes a second upper cradle and a second lower cradle to capture the flexible horizontal rod between the second upper cradle and the second lower cradle
43 The implant of claim 41 including a first lock to lock the fust bone anchoi to the horizontal iod and a second lock to lock the second bone anchor to the horizontal rod and whereto the locking of the first and second bone anchors to the horizontal rod with the first and second bone anchors positioned relative to one \ertebia locks the implant Io the one \ ertebra
44 The implant of claim 41 wherein said first bone anchor includes said first head which is an upper portion that can accept the flexible horizontal rod and said first bone anchor includes a lower portion extending from said upper portion which lower portion is adapted to engage bone
45 The implant of claim 41 wherein one of the upper portion and the lower portion of the first bone anchor can move relative to the other of the upper portion and the lower portion of the first bone anchor.
46 The implant of claim 44 wherein one of the upper portion and the lower portion of the first bone anchor can rotate relative to the other of the upper portion and the lower portion of the first bone anchor.
47. The implant of claim 1 1 including a first lock to lock the first bone anchor to the horizontal rod and a second lock to lock the second bone anchor to the horizontal rod and wherein the locking of the first and second bone anchors to the horizontal rod with the first and second bone anchors positioned relative to one vertebra Socks the implant to the one vertebra.
48 A method of implanting an implant in a spine including the steps of: locating a first hook relative to a part of the spine; locating a second hook relative to a part of the spine, locating a connector between the first hook and the second hook; adjusting the first hook, the second hook and the connector to fit relative to the spine; and locking the connector to the first hook and the second hook in order to lock the implant in the spine.
49 The method of claim 48 wherein the first locating step locates the first hook adjacent to a facet of the spine; and the second locating step locates the second hook adjacent to a facet of the spine and locking step locks the implant about the opposite facets on lateral sides of the spine.
50. The method of claim 48 including the step of causing spikes, fins or stubs of at least one of the first and second hooks to penetrate the bone of the spine to assist in securing the implant to the spine.
5 ! The method of claim 48 wherein said first locating step locates the first hook about and under a first facet of a vertebra of the spine, and the second locating step locates the second hook about and under a second facet of the spine on the same vertebra.
52 The method of claim 48 wherein said first locating step locates the first hook about and under a first facet of a vertebra of the spine on one side of a spinous process of the same vertebra, and the second locating step locates the second hook about and under a second facet of the spine on an opposite side of the same spinous process on the same vertebra.
S3 The method of claim 48 including the step of selecting a connector that is flexible and can support and absorb and be deflected with respect to the load that the spine places on the connector
54. The method of claim 48 including the step of selecting a connector make of PEEK.
55. The method of claim 48 including selecting a first hook that conforms to the shape of a facet and selecting a second hook that conforms to the shape of a facet.
56 The method of claim 48 including the steps of: selecting the connector to be a flexible rod; and said first locking step locks the implant in the spine relative to a first vertebra; locating a third hook relative to a part of the spine; locating a fourth hook relative to a part of the spine; selecting anther connector to be a flexible rod; locating said another connector between the third hook and the fourth hook; adjusting the third hook, the fourth hook and the another connector to fit relative to a first vertebra of the spine; and locking the connector to the third hook and the fourth hook in order to lock the implant in the spine relative to the second vertebra; and connecting a rigid vertical connector between the connector and the another connector so that any spina! load that the implant carries causes a deflection of one or both of the connector and the another connector.
57 A method of implanting an implant in the spine comprising the steps of: selecting a first hook that conforms to the outer lateral side of a facet on a first vertebra and locating the first hook adjacent to the lateral side of the facet, selecting a second hook that conforms to the outer lateral side of an opposite facet on the same first vertebra and locating the second hook adjacent to the lateral side of the opposite facet; place a horizontal rod through the first hook and through the second hook so that the horizontal rod is about parallel to the first vertebra, adjusting the position of the first hook relative to the facet; adjusting the position of the second hook relative to the opposite facet, and securing the first hook to the rod and securing the second hook to the rod in order to secure the implant to the spine.
58 The method of claim 57 including the step of causing spikes, fins or stubs of at least one of the first and second hooks to penetrate the bone of the spine to assist in securing the implant to the spine.
59 The method of claim 57 wherein said first locating step locates the first hook about and under a first facet of a vertebra of the spine, and the second locating step locates the second hook about and under a second facet of the spine on the same vertebra
60. The method of claim 57 wherein said first locating step locates the first hook about and under a first facet of a vertebra of the spine on one side of a spinous process of the same vertebra, and the second locating step locates the second hook about and under a second facet of the spine on an opposite side of the same spinous process on the same vertebra.
61. "The method of ciaim 57 including the step of selecting a horizontal rod that is flexible and can support and absorb and be deflected with respect to the load that the spine places on the connector.
62. "The method of ciaim 57 including the step of selecting a horizontal rod that is make of PEEK.
63 A method to implant an implant in a spine comprising the steps of placing a first anchor in a first vertebra on one side of a spinous process; placing a second anchor in the first vertebra on the opposite side of a spinous process: in any order connecting a flexible horizontal rod to the first anchor and to the second anchor and positioning the flexible horizontal rod to be about parallel to the first vertebra as connected to and between the first and second anchors, wherein said connecting step causes the flexible horizontal rod to be received through a first head of the first anchor and causes the flexible horizontal rod to be received through a second head the second anchor, locking the first anchor to the flexible horizontal rod and locking the second anchor to the flexible horizontal rod in order to secure the implant in the spine and to allow the horizontal rod to absorb and deOect with respect to motion of the spine,
64 The method of c! aim 63 including the step of selecting a horizontal rod that is flexible and can support and absorb and be deflected with respect to the ioad that the spine places on the implant
65. The method of claim 63 including the step of selecting a horizontal rod that is make of PEEK
66 The method of claim 63 including the steps of: placing a third anchor in a second vertebra on one side of another spinous process, placing a fourth anchor in the second vertebra on the opposite side of the another spinous process; in any order connecting another flexible horizontal rod to the third anchor and to the fourth anchor and positioning the another flexible horizontal rod to be about parallel to the second vertebra as connected to and between the third and fourth anchors, wherein said connecting step causes the another ϋexibSe horizontal rod to be received through a third head of the third anchor and causes the flexible horizontal rod to be received through a fourth head the fourth anchor; locking the third anchor to the another flexible horizontal rod and locking the fourth anchor to the another flexible horizontal rod in order to secure the implant in the spine; and
in any order securing a rigid vertical rod to the flexible horizontal rod and the another flexible horizontal rod to allow the horizontal rods to absorb and deflect with respect to motion of the spine.
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US80187106P | 2006-06-14 | 2006-06-14 | |
US60/801,871 | 2006-06-14 | ||
US11/761,116 US20080058808A1 (en) | 2006-06-14 | 2007-06-11 | Implant system and method to treat degenerative disorders of the spine |
US11/761,100 US8043337B2 (en) | 2006-06-14 | 2007-06-11 | Implant system and method to treat degenerative disorders of the spine |
US11/761,116 | 2007-06-11 | ||
US11/761,006 | 2007-06-11 | ||
US11/761,006 US8172882B2 (en) | 2006-06-14 | 2007-06-11 | Implant system and method to treat degenerative disorders of the spine |
US11/761,100 | 2007-06-11 |
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PCT/US2007/070981 WO2007146928A2 (en) | 2006-06-14 | 2007-06-12 | Implant system and method to treat degenerative disorders of the spine |
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Also Published As
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US20080058808A1 (en) | 2008-03-06 |
US8172882B2 (en) | 2012-05-08 |
US20080058807A1 (en) | 2008-03-06 |
WO2007146928A3 (en) | 2008-07-03 |
US8043337B2 (en) | 2011-10-25 |
US20080058806A1 (en) | 2008-03-06 |
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