Systems and methods for stabilizing the motion or adjusting the position of the spine

• US 9,023,084 B2
• Filed: 12/06/2004
• Issued: 05/05/2015
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Kim, Daniel H.
• Primary Examiner(s): HOFFMAN, MARY C
• Application Number:
  US11/006,521
• Publication Number:
  US 20060122620A1
• Time in Patent Office: 3,802 Days
• Field of Search: 606/61, 623 1711- 1716
• US Class Current: 606/248
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine

Abstract

Systems and methods for stabilizing or adjusting the position of at least one spinal motion segment, such as a posterior element distraction system. The system includes an implantable member having at least one of a lateral member and a transverse member. The lateral member may be expandable in at least one dimension, for example, in a direction along the axis of the spine. The expandable member may be an inflatable balloon, expandable scaffolding, strut, or combination thereof and may provide stability and anchoring to the implantable member. The transverse member is configured to engage the spinous process and may extend from the lateral member or may extend between two laterally-opposed members. For example, the transverse members may be configured to engage an outer surface of the spinous process, and as such, act as a saddle or cradle.

Claims

1. A posterior element distraction system for implantation at a spinal motion segment comprising a superior vertebra, an inferior vertebra, each vertebra comprising a posterior element comprising a spinous process, laminal portions and a set of facet joints, and further comprising an interspinous space between the spinous processes, the system comprising:

a delivery configuration for delivery through a working lumen of a delivery system and a deployed configuration for distracting the spinal motion segment;

a first and a second lateral member, the first lateral member configured to extend adjacent to a first side of spinous processes of both superior and inferior vertebrae, the second lateral member configured to extend adjacent to a second side of spinous processes of both superior and inferior vertebrae, each lateral member is configured to expand outside the interspinous space along the side of a spinal motion segment when the lateral member moves from a first unexpanded configuration for insertion between the spinous processes of the inferior and superior vertebrea to a second expanded configuration while the delivery system is detachably coupled to the posterior element distraction system; and

at least one of a transverse member extending transversely between the lateral members, the transverse member is configured to extend across the interspinous space and is further configured to engage a portion of the spinous processes when the posterior element distraction system is located at the spinal motion segment and each lateral member is driven from the first unexpanded configuration to the second expanded configuration by the delivery system such that the posterior element distraction system distracts the superior and inferior posterior elements,

wherein the first and the second lateral member comprises a balloon configuration.

2. The system of claim 1 further comprising a second transverse member, wherein each transverse member is a strap extending between the first and the second lateral members.

6. The system of claim 1, wherein the transverse member has a pre-formed configuration.

7. The system of claim 1, wherein the transverse member has a flexible configuration.

12. The system of claim 1 wherein the at least one of the transverse member includes a first transverse member and a second transverse member, wherein the first transverse member and the second transverse member move away from one another when the posterior element distraction system moves toward the deployed configuration.

13. The system of claim 1 wherein the posterior element distraction system is configured to move from the delivery configuration to the deployed configuration by operation of the delivery system while the posterior element distraction system is connected to the delivery system.

14. The system of claim 1 wherein the at least one of the transverse member includes a first transverse member and a second transverse member, wherein the first and second transverse members move away from each other when the first and second lateral members move from the first unexpanded configuration toward the second expanded configuration such that the first transverse member pushes against the spinous process of the inferior vertebra and the second transverse member pushes against the spinous process of the second vertebra to distract the superior and inferior posterior elements.

3. A posterior element distraction system for implantation at a spinal motion segment comprising a superior vertebra, an inferior vertebra, each vertebra comprising a posterior element comprising a spinous process, laminal portions and a set of facet joints, and further comprising an interspinous space between the spinous processes, the system comprising:

a delivery configuration for delivery through a working lumen of a delivery system and a deployed configuration for distracting the spinal motion segment;

a first and a second lateral member, the first lateral member configured to extend adjacent to a first side of spinous processes of both superior and inferior vertebrae, the second lateral member configured to extend adjacent to a second side of spinous processes of both superior and inferior vertebrae, each lateral member is configured to expand outside the interspinous space along the side of a spinal motion segment when the lateral member moves from a first unexpanded configuration for insertion between the spinous process of the inferior and superior vertebrea to a second expanded configuration while the delivery system is detachably coupled to the posterior element distraction system;

at least one transverse member extending transversely between the lateral members, the transverse member is configured to extend across the interspinous space and is further configured to engage a portion of the spinous processes when the posterior element distraction system is located at the spinal motion segment and each lateral member is driven from the first unexpanded configuration to the second expanded configuration by the delivery system such that the posterior element distraction system distracts the superior and inferior posterior elements; and

a mesh configured to at least partially enclose the first and the second lateral members.

4. A posterior element distraction system for implantation at a spinal motion segment comprising a superior vertebra, an inferior vertebra, each vertebra comprising a posterior element comprising a spinous process, laminal portions and set of facet joints, and further comprising an interspinous space between the spinous processes, the system comprising:

a delivery configuration for delivery through a working lumen of a delivery system and a deployed configuration for distraction the spinal motion segment;

a first second lateral member, the first member configured to extend adjacent to a first side of spinous processes of both superior and inferior vertebrae, the second lateral member configured to extend adjacent to a second side of spinous processes of both superior and inferior vertebrae, each lateral member is configured to expand outside the interspinous space along the side of a spinal motion segment when the lateral member moves from a first unexpanded configuration for insertion between the spinous processes of the inferior and superior vertebrea to a second expanded configuration while the delivery system is detachably coupled to the posterior element distraction system; and

a transverse member extending transversely between the lateral members, the transverse member is configured to extend across the interspinous space and is further configured to engage a portion of the spinous processes when the posterior element distraction system is located at the spinal motion segment and each lateral member is driven from the first unexpanded configuration to the second expanded configuration by the delivery system such that the posterior element distraction system distracts the superior and inferior posterior elements,

wherein the system comprises only one transverse member.

5. A posterior element distraction system for implantation at a spinal motion segment comprising a superior vertebra, an inferior vertebra, each vertebra comprising a posterior element comprising a spinous process, laminal portions and a set of facet joints, and further comprising an interspinous space between the spinous processes, the system comprising:

a first and a second lateral member, the first lateral member configured to extend adjacent to a first side of spinous processes of both superior and inferior vertebrae, the second lateral member configured to extend adjacent to a second side of spinous processes of both superior and inferior vertebrae, each lateral member is configured to expand outside the interspinous space along the side of a spinal motion segment from a first unexpanded configuration to a second expanded configuration, wherein the first lateral member comprises a balloon and the second lateral member comprises a strut; and

at least one transverse member extending transversely between the lateral members, wherein at least one of the first and second lateral members is continuous across the at least one transverse member, and wherein the at least one transverse member is configured to extend across the interspinous space and is further configured to engage a portion of the spinous processes when the system is operatively implanted at a spinal motion segment and the lateral members are in the second expanded configuration, thereby providing distraction between superior and inferior posterior elements.

8. A system for implantation at a spinal motion segment comprising a superior vertebra, an inferior vertebra, each vertebra comprising a posterior element comprising a spinous process, laminal portions and a set of facet joints, and further comprising an interspinous space between the spinous processes, the system comprising:

a posterior element distraction system having a delivery configuration for delivery through a working lumen of a delivery system and a deployed configuration for distracting the spinal motion segment, the posterior element distraction system including

a first and a second lateral member, the first lateral member configured to extend adjacent to a first side of spinous processes of both superior and inferior vertebrae, the second lateral member configured to extend adjacent to a second side of spinous processes of both superior and inferior vertebrae, each lateral member is configured to expand outside the interspinous space along the side of a spinal motion segment when the lateral member moves from a first unexpanded configuration to a second expanded configuration;

at least one of a transverse member extending transversely between the lateral members, wherein at least one of the first and second lateral members is continuous across the at least one of the transverse member, the transverse member is configured to extend across the interspinous space and is further configured to engage a portion of the spinous processes when the posterior element distraction system is operatively implanted at a spinal motion segment and the lateral members are in the second expanded configuration, thereby providing distraction between superior and inferior posterior elements; and

a temporary distraction device having an expanded configuration and an unexpanded configuration and further configured for insertion within the interspinous space, wherein upon expansion of the temporary distraction device, the superior and inferior vertebrae are distracted from each other, and wherein the temporary distraction device comprises a balloon.

9. The system of claim 8, further comprising:

a working channel for delivering the temporary distraction device and the posterior element distraction system, wherein the temporary distraction device is deliverable in the unexpanded configuration.

10. The system of claim 9, wherein the temporary distraction device and the posterior element distraction system are deliverable simultaneously to the spinal motion segment.

15. The system of claim 8 wherein the at least one of the transverse member includes a first transverse member and a second transverse member, and wherein the first transverse member and the second transverse member move away from one another when the posterior element distraction system moves toward the deployed configuration.

16. The system of claim 8 wherein the posterior element distraction system is configured to be moved from the delivery configuration to the deployed configuration by operation of the delivery system while the posterior element distraction system is connected to the delivery system.

17. The system of claim 8 wherein the at least one of the transverse member includes a superior transverse member and an inferior transverse member, wherein the superior and inferior transverse members move away from each other when the lateral members move from the first unexpanded configuration toward the second expanded configuration such that the superior transverse member pushes against the spinous process of the superior vertebra and the inferior transverse member pushes against the spinous process of the inferior vertebra to distract the superior and inferior vertebrae.

11. A posterior element distraction system for implantation at a spinal motion segment comprising a superior vertebra, an inferior vertebra, each vertebra comprising a posterior element comprising a spinous process, laminal portions and a set of facet joints, and further comprising an interspinous space between the spinous processes, the system comprising:

a first and a second lateral member, the first lateral member configured to extend adjacent to a first side of spinous processes of both superior and inferior vertebrae, the second lateral member configured to extend adjacent to a second side of spinous processes of both superior and inferior vertebrae, each lateral member is configured to expand outside the interspinous space along the side of a spinal motion segment from a first unexpanded configuration to a second expanded configuration, wherein the first and the second lateral member comprises a balloon configuration;

at least one of a transverse member extending transversely between the lateral members, the at least one of the transverse member is configured to extend across the interspinous space and is further configured to engage a portion of the spinous processes when the system is operatively implanted at a spinal motion segment and the lateral members are in the second expanded configuration, thereby providing distraction between superior and inferior posterior elements; and

wherein the at least one of the transverse member comprises a balloon configured to interconnect with the lateral members such that the at least one of the transverse member and the lateral members expand from the first unexpanded configuration to the second expanded configuration at substantially the same time.