Artificial disc device

• US 20050192671A1
• Filed: 10/22/2004
• Published: 09/01/2005
• Est. Priority Date: 05/23/2002
• Status: Active Grant

• Current Assignee: Pioneer Surgical Technology Incorporated (Surgalign Holdings, Inc.)
• Original Assignee: Pioneer Laboratories Incorporated
• Inventors: Songer, Matthew N., Kilpela, Thomas S., Berrevoets, Gregory, Trudeau, Jeffrey L., Bao, Qi-Bin, Janowski, Brian Patrick, Yuan, Hansen A.
• Granted Patent: US 8,241,360 B2
• Time in Patent Office: Days
• US Class Current: 623/17.14
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30123 with two diametrically opposed lobes
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30158 trapezoidal
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30245 Partial spheres
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30327 : differing in diameter
• CPC Class Codes: A61F 2002/30331 : made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30369 : Limited lateral translation of the protrusion within a larger recess
• CPC Class Codes: A61F 2002/30387 : Dovetail connection
• CPC Class Codes: A61F 2002/3039 : with possibility of relative movement of the rib within the groove
• CPC Class Codes: A61F 2002/30428 : made by inserting a protrusion into a slot
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30471 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30476 : locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/30485 : plastically deformable
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30528 : Means for limiting said movement
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/3054 : about a connection axis or implantation axis for selecting any one of a plurality of radial orientations between two modular parts, e.g. Morse taper connections, at discrete positions, angular positions or continuous positions
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30574 : with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30588 : filled with solid particles
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30649 : Ball-and-socket joints
• CPC Class Codes: A61F 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/30673 : Lubricating means, e.g. synovial pocket
• CPC Class Codes: A61F 2002/30685 : Means for reducing or preventing the generation of wear particulates
• CPC Class Codes: A61F 2002/30738 : Sleeves
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30919 : Sleeves
• CPC Class Codes: A61F 2002/30934 : Special articulating surfaces
• CPC Class Codes: A61F 2002/30935 : Concave articulating surface composed of a central conforming area surrounded by a peripheral annular non-conforming area
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00574 : Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon

Abstract

An artificial disc device for replacing a damaged nucleus is disclosed. In one form, the device may be inserted in components such that the device may be assembled within and retained by the natural annulus therein. In another form, the device may be inserted into the natural annulus in a collapsed or compressed state or arrangement and then be expanded within and retained by the annulus therein. In a further form, the device may be provided with a releasable connection so that the device may be connected in an insertion configuration and may be released in an operable configuration. Insertion tools and methods are also disclosed.

Claims

1. A prosthetic spinal nucleus device for replacing a nucleus of a spinal disc and for being implanted between adjacent axially spaced upper and lower vertebrae, the device comprising:

a rigid upper shell for contacting the upper vertebra and sized to fit within an annulus of the spinal disc;

a rigid lower shell for contacting the lower vertebra and sized to fit within the annulus of the spinal disc; and

at least one bearing member between the upper and lower shells and allowing for relative movement between the upper and lower shells such that the annulus retains the device therein.

2. The device of claim 1 wherein the at least one bearing member is a polyaxially articulating bearing member between at least one of the upper and lower shells.

3. The device of claim 1 wherein the shells and bearing member may be sequentially inserted through an incision in the annulus, and the device may be assembled within the annulus.

4. The device of claim 1 further including a spacer member forming an articulating bearing member, wherein the device has a compressed arrangement during insertion of the device within the annulus, and the device may be expanded to an expanded arrangement after implantation in the annulus.

5. The device of claim 1 wherein the upper shell has a generally smooth top surface for non-invasive contact with the upper vertebrae within the annulus of the spinal disc, and the lower shell has a generally smooth bottom surface for non-invasive contact with the lower vertebrae within the annulus of the spinal disc.

6. The device of claim 1 wherein each shell has an end with a lateral dimension and an end with a longitudinal dimension larger than the lateral dimension, and each shell may be inserted through an incision in annulus with the end with the lateral dimension leading first into the incision.

7. The device of claim 6 wherein the annulus has a lateral dimension and a longitudinal dimension such that the lateral dimension of the annulus is greater than the longitudinal dimension of the annulus, and each shell maybe positioned such that the lateral dimension of the shell is aligned with the lateral dimension of the annulus.

8. The device of claim 7 wherein each shell may be rotated as it is inserted through the incision so that the inserted shell is positioned such that the lateral dimension of the shell is aligned with the lateral dimension of the annulus.

9. The device of claim 7 wherein each shell may be rotated after it is inserted through the incision so that the inserted shell is positioned such that the lateral dimension of the shell is aligned with the lateral dimension of the annulus.

21. The device of claim 1 wherein the device the upper and lower shells include cooperating structure to allow the shells to be implanted simultaneously between the vertebrae.

10. A prosthetic spinal nucleus device for replacing a nucleus of a spinal disc and for being implanted between adjacent axially spaced upper and lower vertebrae, the device comprising:

a upper shell for contacting the upper vertebra and sized to fit within an annulus of the spinal disc;

a lower shell for contacting the lower vertebra and sized to fit within the annulus of the spinal disc; and

at least one bearing member between the upper and lower shells and allowing for polyaxial movement and sliding of the upper and lower shells movement between the upper and lower shells.

11. The device of claim 10 wherein the bearing member includes:

a convex surface with a radius of curvature; and

a concave surface receiving the convex surface and having a radius of curvature wherein the relative radii of curvature may be selected to provide a stiffness for the polyaxial movement between the upper and lower shells.

12. A prosthetic spinal nucleus device for replacing a nucleus of a spinal disc and for being implanted between adjacent axially spaced upper and lower vertebrae, the device comprising:

a upper shell with a convex top surface for contacting the upper vertebra and selected according to a concavity of the vertebra top surface, the shell being sized to fit within an annulus of the spinal disc;

a lower shell with a convex bottom surface for contacting the lower vertebra and selected according to a concavity of the lower vertebrae, the shell being sized to fit within the annulus of the spinal disc; and

at least one bearing member between the upper and lower shells and allowing for relative movement between the upper and lower shells.

13. The device of claim 12 wherein at least one of the convex surfaces has a radius of curvature greater than a radius of curvature of the vertebra the at least one convex surface contacts.

14. The device of claim 12 wherein at least one of the convex surfaces has a radius of curvature smaller than a radius of curvature of the vertebra the at least one convex surface contacts.

15. The device of claim 12 wherein at least one of the convex surfaces has a radius of curvature equal to a radius of curvature of the vertebra the at least one convex surface contacts.

16. A method of replacing a nucleus of a spinal disc, the steps including:

providing an implant device including a plurality of components;

determining a minimum incision size through which each of the components can pass;

providing an incision in an annulus of the spinal disc such that the incision forms a deformable opening sized according to the minimum incision size through which each of the components can pass;

orienting the components for insertion through the incision;

inserting sequentially the components through the incision; and

assembling the components to form the device within the annulus.

17. The method of claim 16 further including the step of rotating at least one of the components after a leading edge of the component is inserted within the annulus.

18. A method of replacing a nucleus of a spinal disc, the steps including:

providing an implant device having a rigid top member, a rigid bottom member, and a spacer member;

assembling the device in a collapsed arrangement with a pre-determined size in a pre-determined direction;

providing an incision in an annulus of the spinal disc such that the incision forms a deformable incision sized according to the pre-determined size such that the device in the collapsed arrangement can pass through the incision;

inserting the device in the collapsed arrangement through the incision; and

expanding the device such that the device has an expanded arrangement with a size greater than the pre-determined size at least in the pre-determined direction.

19. The method of claim 18 wherein the step of expanding the device includes moving a portion of the spacer member relative to at least one of the top and bottom members.

20. The method of claim 18 wherein the step of expanding the device includes injecting a flowable material into the spacer member to expand the spacer member between the top and bottom members.

22. An artificial disc device for being inserted between upper and lower vertebrae, the artificial disc device comprising:

a disc body;

first and second portions of the body that are connected in an insertion configuration to allow for low force insertion between the vertebrae, and an operable configuration for allowing relative movement between the body portions as the vertebrae move, the first and second body portions being shifted from the insertion configuration to the operable configuration upon insertion between the vertebrae.

23. The artificial disc device of claim 22 wherein the body portions include engagement portions in the insertion configuration sized to engage against the upper and lower vertebrae to cause the body portions to shift from the insertion configuration to the operable configuration as the body portions are inserted between the vertebrae.

24. The artificial disc device of claim 22 wherein the first and second body portions include a releasable connection therebetween that is released with the body portions shifted from the insertion configuration to the operable configuration thereof.

25. The artificial disc device of claim 22 wherein the first and second body portions include a snap-fit connection therebetween so that the body portions are snap-fit together in the insertion configuration.

26. The artificial disc device of claim 22 wherein the insertion configuration comprises a wedge configuration.

27. The artificial disc device of claim 22 wherein the body portions are in a substantially fixed orientation relative to each other in the insertion configuration thereof.

28. The artificial disc device of claim 22 wherein each of the body portions includes:

first and second ends thereof; and

corresponding first ends of the body portions being connected so that the corresponding second ends of each body are spaced from each other by a greater distance than the connected first ends with the body portions in the insertion configuration thereof.

29. The artificial disc device of claim 28 wherein one of the first and second body portions includes a bearing portion with the other body portion extending from the first connected end thereof along the bearing portion and generally away from the one body portion to the second end thereof.

30. A method of implanting an artificial disc device between upper and lower vertebrae, the method comprising:

connecting the disc device in an insertion configuration;

inserting the disc device between the vertebrae;

engaging the vertebrae with portions of the disc device during insertion;

continuing insertion of the disc device causing the connection to be released; and

shifting the disc device to an operable configuration by releasing the connection.

31. The method of claim 30 further including orienting upper and lower members of the disc device in the insertion configuration with upper and lower outer surfaces forming a predetermined angle, wherein the step of connecting the disc device includes connecting the upper and lower members with cooperating structure.

32. The method of claim 31 wherein the step of connecting the upper and lower members includes forming an interference fit between the upper and lower members.

33. The method of claim 32 wherein the interference fit is a snap-fit.

34. The method of claim 33 further including camming the upper and lower surfaces against the upper and lower vertebrae to separate the cooperating structures.

35. A method of replacing a nucleus of a spinal disc, the steps including:

providing an implant device having a major dimension and a minor dimension;

forming an incision in an annulus of the spinal disc having a predetermined size;

orienting the device with the minimum dimension aligned with the incision to keep the predetermined incision size to a minimum;

inserting the device through the incision into the nuclear space; and

turning the device so that at least a portion of the major dimension is aligned with the incision.

36. The method of claim 35 wherein the step of forming an incision includes incising a portion of the annulus at an angle oblique to an anterior-posterior direction of the spinal disc.

37. The method of claim 35 further including selectively attaching an inserter instrument to the device.

38. The method of claim 37 further including fixedly securing the device in a predetermined orientation relative to the inserter instrument prior to the step of inserting the device.

39. The method of claim 38 wherein the inserter instrument includes a grip member, and the step of fixedly securing the device includes securing the grip member with the device.

40. The method of claim 39 further including the step of adjusting the grip member after the step of insertion such that the inserter instrument and artificial disc device may pivot relatively to each other.

41. The method of claim 35 wherein the step of forming an incision includes sizing the incision based on at least the minor dimension of the device.

42. The method of claim 35 further including selecting the device based on one of a size of the spinal disc, an angle formed between the upper and lower vertebrae, and the size of a nuclear cavity.

43. The method of claim 42 further including inserting a trial spacer within the nuclear cavity to select the artificial disc device.

44. The method of claim 43 wherein the step of inserting the trial spacer includes utilizing a trial spacer instrument to direct the trial spacer within the annulus.

45. The method of claim 35 wherein the turning of the device occurs during the step of inserting the device.

46. The method of claim 35 wherein the turning of the device includes contacting an interior wall of the annulus to slide and position the device therewithin.

47. A system for replacing a nucleus of a spinal disc, the system comprising:

a prosthetic nucleus device; and

an insertion tool, wherein the device is rotatably attachable to the insertion tool, and the device may be rotated to at least two discrete positions.

48. A system for replacing a nucleus of a spinal disc, the system comprising:

a prosthetic nucleus device having an end with a minor dimension; and

an insertion tool, wherein the device is attachable to the insertion tool at the end with the minor dimension.

49. A prosthetic spinal nucleus device for replacing a nucleus of a spinal disc, the nucleus device comprising:

an upper shell; and

a lower shell, wherein the nucleus device is implanted between adjacent upper and lower vertebrae, and at least one of the shells having an outer surface with a predetermined angle related to at least one of the vertebrae.