Artificial disc device

• US 9,351,852 B2
• Filed: 08/14/2012
• Issued: 05/31/2016
• 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: Boa, 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:
  US13/585,607
• Publication Number:
  US 20120310287A1
• Time in Patent Office: 1,386 Days
• Field of Search: 623/17.11, 623/17.16
• US Class Current: 1/1
• 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 method of replacing a nucleus of a spinal disc, the steps including:

providing an implant device comprising distinct upper and lower disc members having mating inner arcuate bearing surfaces configured to slidingly engage one another to allow the disc members to shift polyaxially with respect to one another and each having a major dimension extending along a longitudinal axis and a minor dimension transverse to the longitudinal axis;

forming an opening in an annulus of the spinal disc having a predetermined size and defining an insertion axis about which the opening extends;

attaching the upper disc member to a distal end of an inserter instrument at a tool engaging portion of the upper disc member to form a pivotal connection therebetween;

attaching the lower disc member to the distal end of the inserter instrument at a tool engaging portion of the lower disc member to form a pivotal connection therebetween such that each one of the upper and lower disc members is held independently of the other one of the upper and lower disc members by the inserter instrument in a superimposed orientation such that the distinct upper and lower disc members are kept from separating, and each one of the upper and lower disc members is configured to be pivoted about its respective pivotal connection at the distal end of the inserter instrument;

orienting the device with the longitudinal axis aligned with the insertion axis of the opening to keep the predetermined opening size to a minimum;

inserting the device through the opening into the nuclear space along the insertion axis; and

pivoting the device relative to the distal end of the inserter instrument while the device is attached thereto within the nuclear space so that the longitudinal axis of the implant device is transverse to the insertion axis;

releasing the distinct upper and lower disc members from the distal end of the inserter instrument in the nuclear space.

2. The method of claim 1 wherein the step of forming an opening includes incising a portion of the annulus at an angle oblique to an anterior-posterior direction of the spinal disc.

3. The method of claim 1 further including fixedly securing the device in a predetermined orientation relative to the inserter instrument prior to the step of inserting the device.

4. The method of claim 3 wherein the inserter instrument includes a grip member, and the step of fixedly securing the device includes securing the grip member with the device.

5. The method of claim 4 further including the step of adjusting the grip member after the step of insertion such that the inserter instrument and the implant device may pivot relatively to each other.

6. The method of claim 1 wherein the step of forming an opening includes sizing the opening based on at least the minor dimension of the device.

7. The method of claim 1 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.

8. The method of claim 7 further including inserting a trial spacer within the nuclear cavity to select the implant device.

9. The method of claim 8 wherein the step of inserting the trial spacer includes utilizing a trial spacer instrument to direct the trial spacer within the annulus.

10. The method of claim 1 wherein the pivoting of the device occurs during the step of inserting the device.

11. The method of claim 1 wherein the pivoting of the device includes contacting an interior wall of the annulus to slide and position the device therewithin.

12. The method of claim 1, wherein the tool engaging portions of the upper and lower disc members comprise post members, and attaching the upper and lower disc members to the distal end of the inserter instrument comprises receiving each of the post members of the upper and lower disc members with corresponding post member receiving portions of the inserter tool.