Artificial disc device

• US 8,241,360 B2
• Filed: 10/22/2004
• Issued: 08/14/2012
• Est. Priority Date: 05/23/2002
• Status: Expired due to Fees

• Current Assignee: Pioneer Surgical Technology Incorporated (Surgalign Holdings, Inc.)
• Original Assignee: Pioneer Surgical Technology Incorporated (Surgalign Holdings, Inc.)
• Inventors: Bao, Qi-Bin, Trudeau, Jeffrey L., Janowski, Brian Patrick, Songer, Matthew N., Yuan, Hansen A., Kilpela, Thomas S., Berrevoets, Gregory
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US10/971,734
• Publication Number:
  US 20050192671A1
• Time in Patent Office: 2,853 Days
• Field of Search: None
• 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 two-piece prosthetic spinal nucleus device for replacing a nucleus of a spinal disc and for being implanted in an intervertebral space within a natural annulus between end plates of adjacent axially spaced upper and lower vertebrae, the device comprising:

an upper shell for contacting the upper vertebra having opposite sides with a width therebetween and opposite ends with a length therebetween that is longer than the width and sized to fit within an annulus of the spinal disc;

a lower shell for contacting the lower vertebra having opposite sides with a width therebetween and opposite ends with a length therebetween that is longer than the width and sized to fit within the annulus of the spinal disc;

inner facing surfaces of the upper and lower shells;

smooth outer bearing surfaces of the upper and lower shells each extending continuously without interruption across the entire extent thereof for facing and non-invasively contacting the end plates of the adjacent vertebra for sliding engagement therewith;

a bearing interface between the upper and lower shells comprising a pair of arcuate surface portions of the inner facing surfaces of the upper and lower shells formed monolithically thereon with the arcuate surface portions directly engaged with each other for providing a shifting interface therebetween and allowing for polyaxial movement and sliding of the upper and lower shells with respect to one another, wherein the arcuate surface portions include a convex bearing surface with a radius of curvature, and a concave bearing surface receiving the convex bearing surface and having a radius of curvature;

a post having a rigid body with a solid outer gripping surface integral with one of the inner facing surfaces of one of the shells adjacent to one of the ends thereof so as to be directly connected to the one inner facing surface and having an upper free end, the post extending away from the one inner facing surface towards the other inner facing surface so that the upper free end is spaced from the other inner facing surface with the upper and lower shells substantially parallel to one another, the outer gripping surface extending about the rigid body of the post for interfacing with an insertion tool for manipulating one of said shells with the insertion tool to adjust a position of said one shell with respect to the other shell; and

an insertion tool accessible surface portion of the one inner facing surface adjacent to the arcuate surface portion of the one inner facing surface with the post projecting away from the insertion tool accessible surface portion so that the surface portion at least partially surrounds the post and extends substantially across the entire width of the one shell from either side of the post, the arcuate surface portions being arranged and configured such that no portions of the other shell can engage the surface portion of the one inner facing surface of the one shell surrounding the post including on either side thereof for the entire width of the one shell so that the post is exposed on either side and free to be gripped by an insertion tool at various angles relative thereto to allow the insertion tool to manipulate the post while the one shell is pivoted with respect to the insertion tool.

2. The prosthetic spinal nucleus device according to claim 1, wherein the opposite ends are narrow and the opposite sides of each of the shells extending between the narrow ends thereof are longer than the width across the narrow ends to allow the shells to be arranged with the narrow ends of the shells leading the shells as the shells are inserted through an incision smaller than the elongated sides of the shells so that the annulus retains the shells in the intervertebral space.

3. The prosthetic spinal nucleus device of claim 2, wherein the post is disposed on the inner surface of the upper shell adjacent one of the narrow ends.

4. The prosthetic spinal nucleus device of claim 1, wherein the post is disposed on the upper shell such that the upper shell may be positioned by the insertion tool in an insertion configuration, wherein an insertion end of the device has a reduced profile to ease insertion of the device through an opening in the annulus.

5. The prosthetic spinal nucleus device of claim 1, wherein the arcuate surfaces comprise a PEEK material.

6. The prosthetic spinal nucleus device of claim 1, wherein the outer gripping surface of the post includes an arcuate engagement surface portion for rotating the one shell with the insertion tool, and a generally flat abutment surface portion for locking the one shell against rotation with the tool.

7. The prosthetic spinal nucleus device of claim 1, wherein the post has upper and lower portions, wherein the upper portion is enlarged relative to the lower portion.

8. The prosthetic spinal nucleus device of claim 7, wherein the upper and lower portions of the post each have a generally cylindrical configuration.

9. The prosthetic spinal nucleus device of claim 1, wherein the outer gripping surface of the post has a generally annular configuration.

10. The prosthetic spinal nucleus device of claim 1, wherein the convex surface is generally dome-shaped and formed to project integrally and upwardly from the inner facing surface of the lower shell and the concave surface is generally a dome-shaped recess formed in the inner facing surface of the upper shell.

11. The prosthetic spinal nucleus device of claim 10, wherein a substantially flat inner facing surface portion is disposed adjacent the concave surface of the upper shell.

12. The prosthetic spinal nucleus device of claim 1, wherein the insertion tool accessible surface portion is substantially flat.