Artificial functional spinal unit system and method for use

• US 7,794,480 B2
• Filed: 03/08/2006
• Issued: 09/14/2010
• Est. Priority Date: 08/05/2003
• Status: Expired due to Fees

• Current Assignee: Flexuspine Incorporated
• Original Assignee: Flexuspine Incorporated
• Inventors: Gordon, Charles R., Wagner, Erik J., Hanson, Heather S., Harbold, Corey T.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/371,182
• Publication Number:
  US 20060241771A1
• Time in Patent Office: 1,651 Days
• Field of Search: 606/61, 606250-279, 623/16.11, 623 1711- 1716, 403/109.1, 403/187, 403/190, 403/345, 403/347, 403/352
• US Class Current: 606/257
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7005 Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit in the screw or hook heads
• CPC Class Codes: A61B 17/7008 with parts of, or attached to, the longitudinal elements, bearing against an outside of the screw or hook heads, e.g. nuts on threaded rods A61B17/7007 takes precedence
• CPC Class Codes: A61B 17/7023 with a pivot joint
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7037 wherein pivoting is blocked when the rod is clamped
• CPC Class Codes: A61B 17/704 the longitudinal element passing through a ball-joint in the screw head
• CPC Class Codes: A61B 17/7041 with single longitudinal rod offset laterally from single row of screws or hooks A61B17/7044 takes precedence
• CPC Class Codes: A61B 17/7052 of variable angle or length
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/746 the longitudinal elements coupled to a plate opposite the femoral head
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30133 : kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30364 : Rotation about the common longitudinal axis
• CPC Class Codes: A61F 2002/30365 : with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30369 : Limited lateral translation of the protrusion within a larger recess
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30492 : using a locking pin
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30515 : using a locking wedge or block
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30649 : Ball-and-socket joints
• CPC Class Codes: A61F 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/3071 : Identification means; Administration of patients
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/3079 : Stepped or enlarged apertures, e.g. having discrete diameter changes
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• 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 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/0085 : Identification means; Administration of patients
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

A stabilization system for a human spine is provided comprising at least one dynamic interbody device and at least one dynamic posterior stabilization system. In some embodiments the stabilization system comprises a pair of dynamic interbody devices and a pair of dynamic posterior stabilization systems. In some embodiments, a bridge may couple a dynamic interbody device to a dynamic posterior stabilization system. In some embodiments, an elongated member of the dynamic posterior stabilization system may be curved.

Claims

1. A stabilization system for a human spine, comprising:

at least one dynamic interbody device configured to be positioned in a disc space between a first vertebra and a second vertebra, wherein the at least one dynamic interbody device comprises a center of rotation, and wherein the at least one dynamic interbody device accommodates flexion of the first and the second vertebra about the center of rotation; and

at least one dynamic posterior stabilization system configured to be coupled to the first vertebra and the second vertebra, at least one dynamic posterior stabilization system comprising;

a first bone fastener configured to be coupled to the first vertebra;

a second bone fastener configured to be coupled to the second vertebra, wherein the second bone fastener comprises a longitudinal passage;

an elongated member configured to be coupled to the first bone fastener and the second bone fastener, wherein the elongated member is coupled to the second bone fastener such that the second bone fastener can move relative to the elongated member to accommodate movement of vertebrae coupled to the first bone fastener and the second bone fastener, wherein the elongated member comprises a longitudinal axis, wherein the longitudinal axis is curved along at least a portion of its length about a center of curvature,

wherein, during use, the center of curvature of the elongated member aligns or substantially aligns with the center of rotation of the at least one dynamic interbody device when the dynamic interbody device and the dynamic posterior stabilization system are coupled to vertebrae, and

wherein, during use, at least a curved portion of the elongate member comprising the portion of the longitudinal axis curved along its length is configured to pass longitudinally through the longitudinal passage to accommodate flexion of the first vertebra and the second vertebra about the center of rotation;

a first biasing member, during use, at least partially surrounding a first portion of the elongate member located on a first side of the second bone fastener; and

a second biasing member, during use, at least partially surrounding a second portion of the elongate member located on a second side of the second bone fastener opposite the first side.

2. The stabilization system of claim 1, further comprising a bridge coupled to at least one dynamic posterior stabilization system.

3. The stabilization system of claim 1, further comprising a bridge coupled to at least one dynamic posterior stabilization system and to at least one dynamic interbody device.

4. The stabilization system of claim 1, further comprising at least one bias member coupled to the elongated member, wherein at least one bias member is configured to resist movement of the second bone fastener relative to the first bone fastener that accommodates flexion/extension movement of vertebra coupled to the dynamic posterior stabilization system, lateral bending movement of vertebrae coupled to the dynamic posterior stabilization system, or combinations thereof.

5. The stabilization system of claim 4, wherein the resistance provided by the at least one bias member substantially mimics the resistance to movement provided by a normal functional spinal unit.

6. The stabilization system of claim 1, wherein at least one dynamic posterior stabilization system comprises a multi-level dynamic posterior stabilization system.

7. The stabilization system of claim 1, wherein the longitudinal axis of the elongated member is curved along at least a portion of its length substantially at or between the first bone fastener and the second bone fastener.

8. The stabilization system of claim 1, wherein the longitudinal axis of the elongated member is curved along a majority of the length of the elongated member.

9. The stabilization system of claim 1, further comprising a bridge directly coupled to at least one of the first bone fastener and the second bone fastener of the at least one dynamic posterior stabilization system and the bridge coupled to the at least one dynamic interbody device, wherein the bridge comprises a rigid member configured to fix a position of the dynamic interbody with respect to the posterior stabilization system, during use, such that the center of curvature of the elongated member aligns or substantially aligns with the center of rotation of the at least one dynamic interbody device.

10. The stabilization system of claim 1, wherein, during use, the elongated member is coupled to the second bone fastener such that longitudinal movement of the second bone fastener along a length of the longitudinal axis of the elongated member is allowed, such that the second bone fastener is allowed to slide longitudinally along a portion of the elongated member to allow a change in the distance between the first bone fastener and the second fastener to accommodate flexion of the second vertebra relative to the first vertebra.

11. A stabilization system for a human spine, comprising:

at least one dynamic interbody device configured to be positioned in a disc space between a first vertebra and a second vertebra; and

at least one dynamic posterior stabilization system configured to be coupled to the first vertebra and the second vertebra, at least one dynamic posterior stabilization system comprising;

a first bone fastener configured to be coupled to the first vertebra;

a second bone fastener configured to be coupled to the second vertebra, wherein the second bone fastener comprises a longitudinal passage;

an elongated member configured to be coupled to the first bone fastener and the second bone fastener when the first bone fastener and second bone fastener are coupled to the first vertebra and the second vertebra, wherein the elongated member comprises a longitudinal axis, wherein the longitudinal axis is curved along at least a portion of its length;

a first biasing member, during use, at least partially surrounding a first portion of the elongate member located on a first side of the second bone fastener; and

a second biasing member, during use, at least partially surrounding a second portion of the elongate member located on a second side of the second bone fastener opposite the first side,

wherein, during use, longitudinal movement of the first bone fastener along a length of the longitudinal axis of the elongated member is inhibited,

wherein, during use, longitudinal movement of the second bone fastener along a length of the longitudinal axis of the elongated member is allowed, such that the second bone fastener is allowed to slide longitudinally along a portion of the elongated member to allow a change in the distance between the first bone fastener and the second fastener to accommodate flexion of the second vertebra relative to the first vertebra, and

wherein, during use, at least a curved portion of the elongate member comprising the portion of the longitudinal axis curved along its length is configured to pass longitudinally through the longitudinal passage to accommodate flexion of the first and the second vertebra about the center of rotation.

12. The stabilization system of claim 11, wherein lateral rotation of the elongated member about the longitudinal axis and relative to the first bone fastener is inhibited when the elongated member is coupled to the first bone fastener, and wherein lateral rotation of the elongated member about the longitudinal axis and relative to the second bone fastener is allowed to accommodate axial rotation of the first second vertebra relative to the first vertebra.

13. The stabilization system of claim 11, wherein lateral rotation of the elongated member about the longitudinal axis and relative to the second bone fastener is inhibited when the elongated member is coupled to the first bone fastener, and wherein lateral rotation of the elongated member about the longitudinal axis and relative to the first bone fastener is allowed to accommodate axial rotation of the first second vertebra relative to the first vertebra.

14. The stabilization system of claim 11, wherein at least one dynamic interbody device includes a center of rotation, wherein the at least one dynamic interbody device accommodates flexion of the first and second vertebra about the center or rotation, wherein the longitudinal axis of the elongated member is curved along at least a portion of its length about a center of curvature, and wherein, during use, the center of curvature of the elongated member aligns or substantially aligns with the center of rotation of the dynamic interbody device when the dynamic interbody device and the dynamic posterior stabilization system are coupled to vertebrae.

15. The stabilization system of claim 14, further comprising a bridge directly coupled to at least one of the first bone fastener and the second bone fastener of the at least one dynamic posterior stabilization system and the bridge coupled to the at least one dynamic interbody device, wherein the bridge comprises a rigid member configured to fix a position of the dynamic interbody with respect to the posterior stabilization system, during use, such that the center of curvature of the elongated member aligns or substantially aligns with the center of rotation of the at least one dynamic interbody device.

16. The stabilization system of claim 11, further comprising a bridge coupled to at least one dynamic posterior stabilization system.

17. The stabilization system of claim 11, further comprising a bridge coupled to at least one dynamic posterior stabilization system and to at least one dynamic interbody device.

18. The stabilization system of claim 11, further comprising at least one bias member coupled to the elongated member, wherein at least one bias member is configured to resist movement of the second bone fastener relative to the first bone fastener that accommodates flexion/extension movement of vertebrae coupled to the dynamic posterior stabilization system, lateral bending movement of vertebrae coupled to the dynamic posterior stabilization system, or combinations thereof.

19. The stabilization system of claim 18, wherein the resistance provided by the at least one bias member substantially mimics the resistance to movement provided by a normal functional spinal unit.

20. The stabilization system of claim 11, wherein at least one dynamic posterior stabilization system comprises a multi-level dynamic posterior stabilization system.

21. The stabilization system of claim 11, wherein the longitudinal axis of the elongated member is curved along at least a portion of its length substantially at or between the first bone fastener and the second bone fastener.

22. The stabilization system of claim 11, wherein the longitudinal axis of the elongated member is curved along a majority of the length of the elongated member.

23. A method of stabilizing a portion of a human spine, comprising:

coupling at least one dynamic interbody device to a first vertebra and a second vertebra;

securing a first bone fastener to the first vertebra;

securing a second bone fastener to the second vertebra, wherein the second bone fastener comprises a longitudinal passage;

coupling an elongated member to the first bone fastener to inhibit movement of the first bone fastener longitudinally with respect to the elongated member, wherein the elongated member comprises a longitudinal axis, and wherein the longitudinal axis is curved along at least a portion of its length;

coupling the elongated member to the second bone fastener to allow longitudinal movement of the second bone fastener along a length of the longitudinal axis of the elongated member, such that the second bone fastener is allowed to slide longitudinally along a portion of the elongated member during use, wherein at least a curved portion of the elongate member comprising the portion of the longitudinal axis curved along its length is configured to pass longitudinally through the longitudinal passage to accommodate flexion of the first and the second vertebra about the center of rotation;

coupling a first biasing member at least partially surrounding a first portion of the elongate member located on a first side of the second bone fastener; and

coupling a second biasing member at least partially surrounding a second portion of the elongate member located on a second side of the second bone fastener opposite the first side.

24. The method of claim 23, further comprising:

securing a third bone fastener to a third vertebra;

coupling a second elongated member to the second bone fastener to inhibit movement of the second bone fastener longitudinally with respect to the second elongated member; and

coupling the elongated member to the third bone fastener to allow longitudinal movement of the third elongated member with respect to the third bone fastener.

25. The method of claim 23, further comprising coupling a bridge to the second bone fastener.

26. The method of claim 25, wherein coupling the bridge comprises directly coupling the bridge to the second bone fastener, wherein the bridge comprises a rigid member configured to fix a position of the dynamic interbody with respect to the posterior stabilization system, during use, and wherein, during use, the bridge is coupled to the second bone fastener such that the center of curvature of the elongated member aligns or substantially aligns with a center of rotation of the at least one dynamic interbody device.

27. The method of claim 23, wherein coupling at least one dynamic interbody device to a first vertebra and a second vertebra comprises separating the first vertebra from the second vertebra to form a disc space between the vertebrae, positioning a first dynamic interbody device in the disc space on the first side of the vertebrae, and positioning a second dynamic interbody device on a contralateral side of the vertebrae in the disc space.

28. The method of claim 23, wherein the longitudinal axis of the elongated member is curved along at least a portion of its length substantially at or between the first bone fastener and the second bone fastener.

29. The method of claim 23, wherein the longitudinal axis of the elongated member is curved along a majority of the length of the elongated member.