Collapsible, rotatable, and tiltable hydraulic spinal disc prosthesis system with selectable modular components

• US 7,419,505 B2
• Filed: 04/21/2005
• Issued: 09/02/2008
• Est. Priority Date: 04/22/2003
• Status: Expired due to Fees

• Current Assignee: Christopher Galuardi, Lewis W. Fleischmann
• Original Assignee: Christopher Galuardi, Lewis W. Fleischmann
• Inventors: Fleischmann, Lewis W., Galuardi, Christopher
• Primary Examiner(s): Robert; Eduardo C.
• Assistant Examiner(s): Araj; Michael J.
• Application Number:
  US11/110,893
• Publication Number:
  US 20050216084A1
• Time in Patent Office: 1,230 Days
• Field of Search: 606/61, 606/99, 623 1711- 1716
• US Class Current: 623/17.11
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• 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 2002/30566 Helical springs
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30639 having rolling elements between both articulating surfaces
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2310/00203 containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00317 containing silicon nitride

Abstract

A modular hydraulic spinal intervertebral prosthetic device offering individualized optimization of an implantable disc prosthesis by having selectable crown plates modules with differing lordosis angles and differing cross-sectional profiles, and selectable bellows cartridges having differing load-bearing capabilities. The device offers substantially full physiological degrees of motion, and by the incorporation of both a dashpot mechanism and a biasing element within reversibly displaceable and tiltable bellows provides hydraulic load bearing capability. The bellows assembly is advantageously pre-loaded to sub-atmospheric pressure. The dashpot further increases resistance to lateral sheer loading beyond the bellows convolutions acting alone. Rotational coupling of the upper crown plate and center bearings plate permits normal twisting movements, and spinal flexural freedom is provided by the bellows interposed between the center bearings plate and the lower end plate. The bellows also provides a hermetic seal which prevents any wear debris from migrating to the surrounding body tissue.

Claims

1. A modular spinal disc prosthesis system for a surgical implantation of an individually optimized compressible, rotatable and tiltable hydraulic spinal disc prosthesis assembly between a pair of adjacent vertebrae, comprising:

(a) a pair of selectable opposed crown plate modules with chined edges, consisting essentially of a selectable cephalad crown plate module and a selectable caudal crown plate module, with each selectable crown plate module having a predetermined lordotic angle, a predetermined cross-sectional profile, with each of said selectable opposed crown plate modules being fixedly engageable with a vertebral endplate by a plurality of vertebra engaging members fixedly connected to a vertebra engaging surface of each of said selectable opposed crown plate modules;

(b) at least one selectable, compressible, rotatable and tiltable hydraulic disc prosthesis cartridge module, with each selectable disc prosthesis cartridge module comprising an axial load dampening mechanism of a predetermined size and a predetermined load-bearing capacity, wherein at least one selectable cartridge module is sandwiched connectedly between and coupled to said opposed selectable crown plate modules; and

(c) an insertion instrument to facilitate the surgical implantation of said individualized spinal disc prosthesis assembly, wherein said individualized compressible, rotatable and tiltable hydraulic spinal disc prosthesis assembly, comprised of said selectable disc prosthesis cartridge module connectedly interposed between said pair of selectable opposed crown plate;

wherein said axial load dampening mechanism comprises;

(a) a compressible tiltable bellows assembly containing at least one fluid;

(b) a dashpot assembly; and

(c) at least one biasing member positioned within said bellows assembly in co-axial proximity to said dashpot assembly.

2. The modular spinal disc prosthesis system as recited in claim 1, wherein said insertion instrument further comprising a surgical insertion tool having a pair of detachable opposing insertion bars reversibly receivable in a respective slot channel formed on said vertebra engaging surface of said selectable crown plate modules to facilitate thereby the surgical implantation of said individually optimized compressible, rotatable and tiltable hydraulic spinal disc prosthesis assembly positioned between said detachable opposing insertion bars.

3. The modular spinal disc prosthesis system as recited in claim 1, wherein a bellows cartridge module further comprises:

(a) a compressible tiltable bellows assembly;

(b) a pair of opposed endcaps, comprising a cephalad endcap and a caudal endcap, said endcaps connectable to said respective crown plate modules, with said caudal endcap having formed therein at least one sealable fluid conduit fluidically connecting said fluid-tight bellows chamber to an exterior of said spinal prosthesis device;

(c) a center bearings plate being coupled on a caudal side thereof to a cephalad end of said bellows assembly and said caudal endcap being coupled to a caudal end of said bellows assembly, said center bearing plate and said caudal endcap, together defining therebetween a fluid-filled bellows chamber;

(d) a bearing retainer seal member having a radial thrust bearing assembly, said bearing retainer seal member being positioned between and rotationally coupled on a cephalad side to said cephalad endcap and on a caudal side, to said center bearings plate member;

(e) a dashpot assembly positioned between said caudal endcap and said center bearings plate and defining therein a dashpot chamber in fluid communication with said bellows chamber by said at least one sealable fluid conduit, wherein said fluid conduit comprises at least one orifice having a diameter sized to dampen a down stroke of a piston; and

(f) at least one biasing member fixedly positioned within said bellows assembly in co-axial proximity to said dashpot assembly.

4. The modular spinal disc prosthesis system as recited in claim 2, wherein the cross-sectional profile of each of said selectable crown plate modules is substantially congruent with a vertebral endplate to which said selected crown plate module is fixedly positioned.

5. The modular spinal disc prosthesis system as recited in claim 2, wherein said selectable cephalad crown plate module is provided with a first predetermined lordotic angle ranging from 0 degrees to 30 degrees, and said selectable caudal crown plate module is provided with a second predetermined lordotic angle ranging from 0 degrees to 30 degrees.

6. The modular spinal disc prosthesis system as recited in claim 5, wherein the cephalad crown plate module and the caudal crown plate module are fixedly positioned onto said respective endcaps of the bellows assembly by a screw threadingly advanced into a respective threaded through hole formed in said crown plate modules and received into a recess formed in said endcaps.

7. The modular spinal disc prosthesis system as recited in claim 5 wherein a vertebra engaging surface of said pair of selectable opposed crown plate modules includes a plurality of endplate engaging spike members projecting therefrom for securing said crown plate modules to the respective endplates of the adjacent vertebrae.

8. The modular spinal disc prosthesis system as recited in claim 3 wherein said center bearings plate member has a cephalad surface with an annular groove formed therein and said cephalad endcap has a corresponding annular groove formed on a caudal surface therein, and said cephalad endcap has a plurality of ball bearings received within a race formed by a juxtaposition of said annular groove of said cephalad endcap and said annular groove of said center bearings plate member.

9. The modular spinal disc prosthesis system as recited in claim 3, said dashpot assembly further comprising:

(a) a piston formed on an inner surface of said center bearings plate and protruding through a bore of a spherical bearing slidingly engaged to an outer surface of said piston and rotationally contiguous within a retaining ring element co-axial with and positioned inside said bellows assembly; and

(b) a dashpot recess formed on an inner surface of said caudal endcap to receive said piston therein, said dashpot recess being in fluid communication with said at least one fluid conduit, wherein said dashpot assembly is fixedly positioned centrally within and co-axial with said bellows assembly.

10. The modular spinal disc prosthesis system assembly as recited in claims 7 or 9, wherein said bearings are composed of a hard substantially inelastic material chosen from the group consisting of a ceramic, a metal, a high-density polymer, and a combination thereof.

11. The modular spinal disc prosthesis system as recited in claim 8, wherein said ceramic material comprises Silicone Nitride Si₃ N₄.

12. The modular spinal disc prosthesis system as recited in claim 3 wherein said compressible, rotatable and tiltable bellows assembly is pre-loaded according to the method comprising the steps of:

(a) providing a compressible tiltable bellows assembly having a bellows member with a cephalad opening and a caudal opening and formed from a plurality of washers sealingly connected edgewise one to another, and having a cephalad endcap and a caudal endcap fixedly attached to said openings respectively to define thereby a fluid-tight bellows chamber having at least one fluid conduit formed therethrough and fluidly connecting said bellows chamber to an exterior to allow ingress of a fluid in a subsequent filling operation;

(b) subsequently, compressing said bellows assembly to a predetermined full stroke excursion, and subsequently applying a constraining member to said compressed bellows assembly to maintain the assembly in a compressed condition;

(c) subsequently, fully immersing said compressed bellows assembly in a volume of at least one fluid;

(d) subsequently, exposing said immersed compressed bellows assembly to a predetermined sub-atmospheric pressure at a predetermined temperature under a vacuum condition so as to evacuate air from an interior of said bellows assembly;

(e) subsequently, admitting an atmosphere of pressure into the vacuum condition to cause thereby said immersed bellows assembly to fill with said at least one fluid;

(f) subsequently, returning said compressed fluid-filled bellows assembly to atmospheric pressure;

(g) subsequently, sealing said at least one fluid conduit with a sealing member; and

(h) subsequently, uncompressing said bellows assembly to expand the assembly to a substantially no-load condition by releasing said constraining member maintaining the compressed condition of said bellows, whereby a biasing member positioned within the compressed bellows assembly exerts a distracting force to separate said caudal endcap from said cephalad endcap and thereby establish a predetermined sub-atmospheric pre-load pressure within said expanded pre-loaded bellows assembly.

13. The modular spinal disc prosthesis system as recited in claim 1, wherein the insertion instrument comprises:

(a) a handle assembly having a hand grip and a rotatable knob at a distal position;

(b) an elongate hollow shaft connecting said handle assembly proximally to an effector head, said effector head having a top surface and a bottom surface, and further having a respective pair of top and bottom proximal arcuate engaging edges provided with a substantially circular concave profile and a chined contour matingly complementary to said chined edges of the respective crown plate modules;

(c) an effector rod slidably positioned longitudinally within said elongate shaft and connecting said rotatable knob to at least one effector cam housed within said effector head;

(d) an upper pair of pawls and a lower pair of pawls, each of said paired pawls displaceably juxtaposed with at least one respective pair of lever arms in displaceable juxtaposition with said cam, with each pair of pawls positioned to be protrudingly displaceable through a respective pair of openings formed through a top and a bottom surface of said effector head, wherein rotation of said knob causes a displacement of said cam by a displacement of said effector rod, so as to displace said pawls through said respective openings, said pawls being received into a corresponding set of pawl recesses formed on at least one an inner surface of said opposed crown plate modules.

14. A method of preloading a compressible, rotatable and tiltable bellows assembly for an axial-load-bearing shear-resisting prosthetic device comprising the steps of:

(a) providing a compressible tiltable bellows assembly having a bellows member with a cephalad opening and a caudal opening and formed from a plurality of washers sealingly connected edgewise one to another, and having a cephalad endcap and a caudal endcap fixedly attached to said openings respectively to define thereby a fluid-tight bellows chamber having at least one fluid conduit formed therethrough and fluidly connecting said bellows chamber to an exterior to allow ingress of a fluid in a subsequent filling operation;

(b) subsequently, compressing said bellows assembly to a predetermined full stroke excursion, and subsequently applying a constraining member to said compressed bellows assembly to maintain the assembly in a compressed condition;

(c) subsequently, fully immersing said compressed bellows assembly in a volume of at least one fluid;

(d) subsequently, exposing said immersed compressed bellows assembly to a predetermined sub-atmospheric pressure at a predetermined temperature under a vacuum condition so as to evacuate air from an interior of said bellows assembly;

(e) subsequently, admitting an atmosphere of pressure into the vacuum condition to cause thereby said immersed bellows assembly to fill with said at least one fluid;

(f) subsequently, returning said compressed fluid-filled bellows assembly to atmospheric pressure;

(g) subsequently, sealing said at least one fluid conduit with a sealing member; and

(h) subsequently, uncompressing said bellows assembly to expand the assembly to a substantially no-load condition by releasing said constraining member maintaining the mechanically compressed condition of said bellows, whereby a biasing member positioned within the compressed bellows assembly exerts a distracting force to separate said caudal endcap from said cephalad endcap and thereby establish a predetermined sub-atmospheric pre-load pressure within said expanded pre-loaded bellows assembly.

15. A unitary compressible, rotatable and tiltable hydraulic spinal disc prosthesis assembly for a surgical implantation between a pair of adjacent vertebrae, comprising:

(a) a cephalad crown plate member with a cephalad vertebral engaging surface formed with a convex profile to provide a substantially fixed complementary juxtaposition with a concave shape of a vertebral endplate;

(b) at least one center bearings plate member rotationally coupled to said cephalad crown plate member and further comprising a radial thrust bearing assembly;

(c) a caudal crown plate member hydraulically coupled to said center bearing plate member and having a caudal vertebral engaging surface formed with a convex profile to provide a substantially fixed complementary juxtaposition with a concave shape of a vertebral endplate;

(d) a bellows assembly having a bellows chamber defined therein, fixedly interposed between said caudal crown plate member and said center bearings plate member;

(e) a dashpot device for dampening axial force loads and for resisting shearing force loads between said cephalad crown plate member and said caudal crown plate member, being positionally located between said center bearings plate member and said caudal crown plate member within and coaxial with said bellows assembly; and

(f) at least one biasing member in coaxial proximity with said dashpot device for further dampening axial force loads on said unitary compressible, rotatable and tiltable hydraulic spinal disc prosthesis assembly.

16. The unitary compressible, rotatable and tiltable hydraulic spinal disc prosthesis assembly for a surgical implantation between a pair of adjacent vertebrae as recited in claim 15, wherein said bellows chamber is provided with a pre-loaded sub-atmospheric pressure.