Artificial cervical and lumbar discs, disc plate insertion gun for performing sequential single plate intervertebral implantation enabling symmetric bi-disc plate alignment for interplate mobile core placement

Abstract

An artificial replacement disc includes a pair of substantially parallel plates formed to occupy a space defined by vertebral endplates, each of the plates including a plurality of spikes on a first surface and a concave trough formed on a second surface opposite of the first surface. A mobile core includes a core rim with opposing convex surfaces extending from opposite sides of the core rim, the mobile core being capable of being disposed between the pair of plates to permit the vertebral endplates to move relative to one another. The spikes on each of the plates extend substantially away from the mobile core and the convex surfaces are formed to integrally fit within the concave trough of at least one of the plates. The core rim limits lateral movement of the mobile core relative to the parallel plates. One or more insertion tools for inserting and implanting the replacement disc are also described.

Claims

1. An artificial disc system comprising: an artificial disc comprising: first and second plates formed to occupy a space defined by vertebral endplates of a spine, each of the first and second plates including an endplate-engaging surface having plurality of anchors and a core-engaging surface positioned opposite the endplate-engaging surface; and a mobile core sized and configured to be positioned between the first and second plates to permit the first and second plates to move relative to one another, wherein the anchors on the endplate-engaging surface extend substantially away from the mobile core and the core-engaging surfaces engage first and second plate-engaging surfaces of the mobile core, wherein both of the first and second plate-engaging surface are configured to slide against adjacent core-engaging surfaces of the first and second plate and wherein at least one of the first and second plate-engaging surface of the mobile core is substantially convex such that the first plate can move with respect to the second plate about an x-axis for lateral bending, a y-axis for flexion/extension, and a z-axis for axial rotation of the spine, wherein the core-engaging surface of the first plate is substantially concave and is sized and shaped for engaging a convex portion of the first plate-engaging surface of the mobile core, wherein the plurality of anchors on the endplate-engaging surface of the first plate comprise a first group of anchors on a left side of the first plate and a second group of anchors on a right side of the first plate with a middle portion of the first plate having no anchors between the first and second groups of anchors, wherein the plurality of anchors on the endplate-engaging surface of the second plate comprise a third group of anchors on a left side of the second plate and a fourth group of anchors on a right side of the second plate with a middle portion of the second plate having no anchors between the third and fourth groups of anchors; and a surgical tool for inserting the artificial disc between vertebral endplates, the surgical tool comprising: a handle; an elongate insertion portion extending distally away from the handle portion; and an implant holder connected at a distal end of the elongate insertion portion and having a first tip sized and configured to engage the first plate and a second tip size and configured to engage the second plate so as to hold both the first and second plates relatively firmly during insertion and position of the first and second plates in the space defined by the vertebral endplates of the spine, wherein the implant holder comprises a claw having first and second curved portions that engage the first plate to hold the first plate, wherein the first curved portion of the claw is pivotable with respect to the second curved portion of the claw so as to release the first plate when the claw is opened.

2. The artificial disc system of claim 1, wherein the claw is biased to a closed position in a natural state to hold the first plate and the claw releases the first plate only in response to a force exerted to open the claw.

3. The artificial disc system of claim 1, wherein the claw comprises a spring that pre-loads the claw to bias the claw to a closed position to hold the first plate.

4. The artificial disc system of claim 3, wherein the spring comprises a leaf spring.

5. The artificial disc system of claim 1, wherein the first plate can tilt with respect to the second plate by over 8 degrees with respect to each of the x-axis and the y-axis.

6. The artificial disc system of claim 1, wherein the mobile core comprises a rim configured to engage a projecting portion on at least one of the first and second plates to limit movement of the mobile core with respect to the at least one of the first and second plates.

7. The artificial disc system of claim 1, wherein the artificial disc is sized and configured to be a cervical artificial disc to be inserted in a cervical disc space.

8. The artificial disc system of claim 1, wherein the convex portion of the first plate-engaging surface of the mobile core has a first height and a first radius with first height less than the first radius, wherein the mobile core has a radially outer portion that is positioned radially outward of the convex.

9. The artificial disc system of claim 1, wherein the mobile core has a first width along the x-axis from a core front to a core back and a second width along the y-axis from a first core side to a second core side, and wherein the second width is equal to the first width.

10. The artificial disc system of claim 1, wherein the mobile core has a first width along the x-axis from a core front to a core back and a second width along the y-axis from a first core side to a second core side, and wherein the second width is at least as great as the first width.

11. The artificial disc system of claim 1, wherein the core-engaging surfaces of both of the first and second plates have substantially curved portions, wherein both of the plate engaging surfaces of the mobile core have substantially curved portions sized and shaped to engage the substantially curved portions of the core-engaging surfaces of the first and second plates, and wherein the first tip of the implant holder is an elongate upper tip and the second tip of the implant holder is an elongate lower tip positioned below the elongate upper tip.

12. The artificial disc system of claim 11, wherein the surgical tool attaches to the first and second plates without engaging the mobile core.

13. The artificial disc system of claim 11, wherein the surgical tool comprises at least one hinge actuatable to allow for grabbing and releasing of the artificial disc and comprises a leaf spring configured to bias the surgical tool in a first position.

14. The artificial disc system of claim 11, wherein the first plate is configured to be capable of tilting with respect to the second plate by over 8 degrees with respect to each of the x-axis and the y-axis.

15. The artificial disc system of claim 11, wherein curved portion of the core-engaging surface of the first plate comprises a concave portion, wherein the core-engaging surface further comprises a substantially flat portion extending circumferentially around the concave portion of the core-engaging surface of the first plate.

16. The artificial disc system of claim 15, wherein the core-engaging surface of the first plate comprises a raised rim between the concave portion and the flat portion.

17. The artificial disc system of claim 11, wherein the artificial disc is sized and configured to be a cervical artificial disc to be inserted in a cervical disc space.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1A is an anterior (or posterior) view of an exemplary cervical artificial disc.

(2) FIG. 1B is an isometric view of the cervical artificial disc of FIG. 1A.

(3) FIG. 1C is an exploded view of the cervical artificial disc of FIG. 1A.

(4) FIG. 1D is a superior (or inferior) view of the cervical artificial disc of FIG. 1A.

(5) FIG. 2A is a side view of an exemplary cervical artificial disc mobile core.

(6) FIG. 2B is an isometric view of the exemplary cervical artificial disc mobile core.

(7) FIG. 2C is a front (or back) view of the exemplary cervical artificial disc mobile core.

(8) FIG. 3A is a side view of an exemplary cervical artificial disc superior or inferior plate.

(9) FIG. 3B is a top oblique-trough side view of the exemplary cervical artificial disc superior or inferior plate.

(10) FIG. 3C is a top oblique-spike view of the exemplary cervical artificial disc superior or inferior plate.

(11) FIG. 3D is a front-trough side view of the exemplary cervical artificial disc superior or inferior plate.

(12) FIG. 3E is a front-spike side view of the exemplary cervical artificial disc superior or inferior plate.

(13) FIG. 4A is a cross-sectional view of a cervical disc core showing the angular movements about the x-axis of the cervical disc core with respect to the upper and lower cervical plates (lateral bending).

(14) FIG. 4Bi is a front view of later cervical disc bending.

(15) FIG. 4Bii is a side view of flexion/extension cervical artificial disc motion.

(16) FIG. 4Ci is a front view of the artificial disc showing the rotations of the mobile core between the two cervical disc plates about the x-axis (lateral bending or roll).

(17) FIG. 4Cii is a side view of the artificial disc showing the y-axis (flexion/extension or pitch).

(18) FIG. 4Ciii is a perspective view of the artificial disc showing the z-axis (rotation or yaw).

(19) FIG. 5A is a front view of a cervical disc plate insertion gun.

(20) FIG. 5B is a top view of the cervical disc plate insertion gun.

(21) FIG. 5C is a bottom view of the cervical disc plate insertion gun.

(22) FIG. 6A is a perspective, left-side, cut-away view of the cervical disc plate insertion gun.

(23) FIG. 6B is a left side, bottom angle view of the cervical disc plate insertion gun.

(24) FIG. 6C is a right side, top angle view of the cervical disc plate insertion gun.

(25) FIG. 6D is a right side, bottom angle view of the cervical disc plate insertion gun.

(26) FIG. 6E is a cut-away view of the tool tip lower cervical disc replacement plate release mechanism.

(27) FIG. 7A is a view of an outside left enclosure of the cervical disc plate insertion gun.

(28) FIG. 7B is a view of an inside left enclosure of the cervical disc plate insertion gun.

(29) FIG. 7C is a view of an outside right enclosure of the cervical disc plate insertion gun.

(30) FIG. 7D is a view of an inside right enclosure of the cervical disc plate insertion gun.

(31) FIG. 8A is a top view of inner components of the cervical plate insertion gun including the lower insertion handle.

(32) FIG. 8B is a lower insertion handle bottom view.

(33) FIG. 8C is top view of a lower insertion link.

(34) FIG. 8D is bottom view of the lower insertion link.

(35) FIG. 8E is a view of the wedge link.

(36) FIG. 8F is a top view of the upper insertion handle.

(37) FIG. 8G is a lower view of the upper insertion handle lower view.

(38) FIG. 8H is a close-up bottom view of a rear portion of the upper insertion handle.

(39) FIG. 8I is a close-up, top view of a forward portion of the upper insertion handle.

(40) FIG. 8J is a top view from left of the upper insertion release link.

(41) FIG. 8K is a top view from a right side of the upper insertion link.

(42) FIG. 8L is a view of a manual upper disc replacement plate driver.

(43) FIG. 8M is a view of a trigger spring.

(44) FIG. 8N is a view of a trigger.

(45) FIG. 8O is a view of a wedge.

(46) FIG. 9A is a perspective cut away view of an exemplary lumbar disc plat insertion gun.

(47) FIG. 9B is a cut-away view of the tool tip of the lower lumbar disc replacement plate release mechanism.

DESCRIPTION OF PREFERRED EMBODIMENTS

(48) The Medical Device of FIG. 1-9.

(49) Referring now to FIGS. 1-9, the above described problems of the background art can be solved in the cervical spine (and lumbar spine) after the performance of an anterior complete cervical discectomy. The disc device 10 includes an upper cervical plate 100 and lower cervical plate 110, one of which is inserted first by a plate insertion gun 500. The opposite (second) cervical disc plate 110 is then inserted with the plate insertion gun 500 maintaining parallel opposition, with opposite plates 100, 110 and troughs 102, 112 perfectly aligned. A mobile core 150 is then inserted and sandwiched in-between both cervical plates 100, 110.

(50) FIGS. 1A-D illustrate different views of the cervical artificial disc 10. The disc 10 includes an upper plate 100 and a lower plate 110. Each plate has a plurality of spikes 101, 111, e.g., six spikes 101, 111 on each plate in a preferred embodiment, on an outer surface of the respective plate, and a centralized trough 102, 112 on an inner surface of each plate 100, 110.

(51) FIGS. 2A-C illustrate different views of the cervical mobile core 150. The core 150 has a centralized base rim 151 with a superior convexity 152 which interacts with the trough 102 of the upper plate 100, and an inferior convexity 153 which interacts with the trough 112 of the lower plate 110.

(52) FIGS. 3A-E illustrate different views of the cervical plate (superior or inferior) 100 (110). The plate 100 includes a base 114. On an upper surface of the inferior plate 110 is a trough 112. On a lower surface of the inferior plate 110 are 6 peripherally arranged spikes 111. The position of the trough 112 and spikes 111 are reversed for the superior plate (100). A groove 113 is defined by the trough 112 (102) and base 114 (104) of each plate 110 (100).

(53) FIG. 4A illustrates a cross-sectional view of the cervical artificial disc 10 and the degrees of motion of the mobile core 150 movement about the x-axis with respect to the upper plate 100 and lower plate 110. Each disc plate 100 can bend about the x axis by 4.39 degrees clockwise and counter-clockwise (lateral bending). This means that a disc plate 100, 110 can move or +8.78 degrees with respect to the opposite plate 110, 100.

(54) FIG. 4B illustrates a front view of lateral bending of the artificial disc 10 (FIG. 4Bi), and a side view illustrating flexion-extension of the cervical disc 10 about the y axis which is 4.39 degrees in either flexion or extension.

(55) FIG. 4C illustrates the rotation of the mobile core 150 between two cervical plates 100, 110 about the x (FIG. 4Ci), y (FIG. 4Cii) and z (FIG. 4Ciii) axes. Rotation about the x-axis is referred to as roll (alpha) which is lateral bending. Rotation about the y axis is referred to as pitch (Beta) which is flexion/extension. Rotation about the z axis is referred to as yaw (gamma) which is axial rotation. These figures display different views that show a reference frame for the disc assembly 10 with an origin O at the center of the core 150. The axes of rotation pass through the spherical face of the core 150 which is lower than 0 but are parallel to both the x and y axes. The rotation of the disc plates 100, 110 about the z-axis is constrained only by the spine motions once the disc 10 is implanted.

(56) FIGS. 5-8 illustrate the components of the cervical disc plate insertion gun 500. Various opening mechanism functions will be described in greater detail hereinafter with respect to FIGS. 5-8. The handle 512 of the opening mechanism is made up of left and right enclosures 501, 502 (FIGS. 5, 6, and 7). FIG. 7 illustrates the inside and outside aspects of left and right enclosures 501, 502. These enclosures 501, 502 are held together by five enclosure fastening screws 590 (FIG. 6B). The handle 512 holds the mechanism used to insert the upper disc plate 100 and lower disc plate 110 (FIGS. 5-6, and FIG. 8) into the vertebrae. The mechanism has two functions, including: 1) Holding onto the disc plates 100, 110 until the user releases them, and 2) opening the tip 560 and forcing one disc plate at a time into a vertebra.

(57) 1. Holding onto the Discs Until User Releases them

(58) The mechanism has two tips 565, 580 each holding a disc plate 100, 110. The lower tip 580 is composed of two parts: the lower insertion release link 576 and the lower insertion release handle 551 (FIGS. 6 and 8). The upper tip 565 includes two parts: the upper insertion handle 550 and the upper insertion link 575 (FIGS. 6 and 8). Each tip 565, 580 works like a lobster claw that holds a disc plate by the groove 552 on its cylindrical extrusion. When the tip 565, 580 is closed the two opposing parts e.g. the lower insertion release link 576 and the lower insertion release handle 551 (FIGS. 6 and 8) hold a disc plate 110 firmly.

(59) A tip 580 opens to release a disc plate as follows. A lower tension cable 571 pulls on the lower insertion release link 576 (FIGS. 6 and 8) that pivots about the lower release pin 598 (FIG. 6) and opens up a gap big enough to loosen the grip on the disc groove 552. The lower tension cable 571 (FIG. 6) can only exert a tensile force to open the lobster claw 580. The natural state of the lobster claw 580 is to be closed. This is ensured by pre-loading the lower insertion release link 576 with the help of a leaf spring 599 cut into the lower insertion release handle 551 (FIGS. 6E and 8). The lower tension cable 571 pulls on the lower insertion release link 576 (FIGS. 6 and 8) each time the user presses on the lower release button 540. The lower tension cable 571 is clamped on one end by a lower rear crimp 592 (FIGS. 6 and 8). Hence when the lower release button 540 is pressed, the tension on the lower tension cable 571 increases (in the same way the tension of a guitar string increase when one presses on the string with a finger). The tension then pulls the lower insertion release link 576 forcing it to swing open. When the user lets go of the button 540, the tension disappears and the spring 599 carved in the lower insertion release handle 551 forces the lower insertion release link 576 to swing closed (FIG. 6E).

(60) The upper tip 565 works in a similar fashion except that its opening is triggered by the upper release button 530.

(61) 2. Opening its Tip and Forcing One Disc at a Time into a Vertebra

(62) The mechanism tips 565, 580 open each time the user presses on trigger 510. When the trigger 510 rotates, it pushes on the wedge link 513 which in turn pushes on the wedge part 525 (FIG. 8). The wedge part 525 is wedged at its front action end that creates a gap in between the lower tool tip 580 and upper tool tip 565 forcing them to open.

(63) A typical disc insertion operation starts with a lower disc plate 110 placed in the lower tip 580 and the opposing upper disc plate 100 placed on the upper side but away from the tip 565 (as shown in FIGS. 5,6, and 8). A channel 553 along the upper tip 565 that is formed by the upper insertion release handle 550 and the upper insertion release link 575 which holds the second disc plate 100 in place and serves to guide it to the tip 565 when needed.

(64) Once the tool tip 560 is inserted into the inter-vertebral space, the first disc plate 100 is inserted into the lower vertebra by opening the tool tip 560. To keep alignment, the lower tool tip 585, lower lobster claw, is kept closed (FIG. 6), securing the disc plate just inserted. The tool 500 should be left in place. The second, upper, disc 100 initially placed in the upper tool half, away from the upper lobster claw 565 but away from the tip is then slid down to the end of the upper lobster claw 565 by a flexible and manually activated upper disc replacement plate driver 520 (FIGS. 6 and 8). Once the second disc 100 is positioned at the tip of the upper lobster claw 565 (FIG. 6), the tool tip 560 is opened once more, i.e., the upper tip 565 and lower lobster claw tip 580 are separated from each other, by virtue of the wedge 525 that is activated by the trigger 510, via wedge link 513 action. Once the second, upper, disc plate 100 is inserted, the user can press on the upper release button 530 and lower release button 540 to release both discs (by opening the upper and lower lobster claws 565, 580) and at the same time close the tool tip 560 (by releasing the trigger 510). The tool tip 560 then closes while both lobster claws 565, 580 remain open, leaving both disc plates 100, 110 in place. The tool tip 560 can then be removed from the patient and a mobile core placed in between the two aligned disc plates 100, 110.

(65) This anterior cervical disc gun can be modified and enlarged for placement of anterior lumbar disc plates. FIG. 9A illustrates the modified posterior lumbar disc plate insertion gun 700. The gun 700 is identical to the cervical disc plate insertion gun 500 except its tips 660 are angled to allow insertion of the specifically sized lumbar disc plates 100, 110 in the posterior lumbar spine underneath the thecal sac.

(66) FIG. 9B illustrates an enlarged cut-away view of the tool tip 660 of the lumbar lower disc replacement plate release mechanism 670. The mechanism 670 is identical to that described for the cervical mechanism which is illustrated FIG. 6E. The tips 660 of the lumbar tool are however, specifically designed and adapted for the typically bean shaped lumbar disc plates.

(67) The Surgical Method

(68) The method of insertion of the cervical artificial disc (or lumbar artificial disc) into the anterior cervical spine can be performed open microscopically, or closed tubularly, using endoscopic and/or fluoroscopic guidance.

(69) After the adequate induction of anesthesia the patient is positioned in the supine position. Routine exposure of the anterior cervical spine is performed and the appropriate disc space is radiographically identified and exposed. A routine complete anterior cervical discectomy is performed.

(70) The cervical disc plates are inserted onto the cervical disc plate insertion gun 500. The tips 560 of the gun 500 are placed into the intervertebral space. Fluoroscopy is used to assure centrality of disc plate placement.

(71) The trigger 510 of the gun 500 is depressed and the bottom plate 110 is inserted into the lower vertebrae. Once this penetrates the bone, the lower plate releasing button 540 is depressed, thereby releasing the plate from the inserter claws 580 (FIG. 6E). The second upper plate 100 is now manually driven into the space by the gun's manual plate driver 520. Because of the design of the gun 500, the upper plate 100 is perfectly aligned with the lower plate 110. The gun trigger 510 is depressed and this drives the upper plate 100 into the upper vertebrae. The upper plate releasing button 530 is now depressed, releasing the upper plate 100 from the inserter lobster claws 565. The gun 500 is removed from the interspace. A mobile core 150 of the appropriate height is selected and placed in between the upper and lower cervical disc plates 100, 110, respectively. The patient is closed routinely.

(72) The surgical method for the posterior insertion of the PPLTAD into the posterior lumbar interspace can be performed open microscopically, or closed tubularly, using endoscopic and or fluoroscopic guidance.

(73) After the adequate induction of anesthesia the patient is positioned in the prone position. A midline incision is made, the appropriate unilateral lamina is radiographically identified and exposed, and a unilateral hemi-laminotomy is performed preserving facet stability. A complete discectomy is performed, and the superior and inferior endplates are exposed. The lumbar plate insertion gun 700 is placed underneath the thecal sac. Fluoroscopic guidance may be used to verify centrality of lumbar disc plate placement. The trigger of the gun 700 is depressed which leads to insertion of the lower lumbar disc plate 100 into the lower vertebra. The lower lumbar disc plate releasing button is depressed which releases the plate from the inserter claws 551 (FIG. 9B). The second upper plate 100 is now manually driven into the interspace by the gun's 700 manual plate driver (520). Because of the design of the gun mechanism as described above, the second plate 100 is now perfectly aligned with the first lumbar disc plate 110. The gun trigger is depressed, and this drives the upper plate 100 into the upper vertebrae. The upper lumbar disc plate release button is now depressed and this releases the upper lumbar disc plate from the claws of the inserter gun 700. The gun 700 is removed from the space. An appropriately sized mobile core 150 is now inserted in between upper and lower lumbar disc plates 100, 110. The patient is closed routinely.

(74) The current device allows safe placement of lumbar and cervical artificial discs into the spine without intervertebral distraction, and therefore places minimal tension on facet joints. The method of insertion is quick, gentle, and time efficient. The plate insertion gun could potentially be adapted for other inter joint orthopedic devices, and further adaptations may have applications in manufacturing, toy, carpentry and other industries.