Systems and methods for posterior dynamic stabilization of the spine

• US 10,278,744 B2
• Filed: 04/22/2015
• Issued: 05/07/2019
• 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: Altarac, Moti, Tebbe, Shawn, Kim, Daniel H., Flaherty, J. Christopher
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US14/693,572
• Publication Number:
  US 20160030092A1
• Time in Patent Office: 1,476 Days
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• 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 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/681 Alignment, compression, or distraction mechanisms
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0077 : Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include an expandable spacer having an undeployed configuration and a deployed configuration, wherein the spacer has axial and radial dimensions for positioning between the spinous processes of adjacent vertebrae. The systems include one or more spacers and a mechanical actuation means for delivering and deploying the spacer. The methods involve the implantation of one or more spacers within the interspinous space.

Claims

1. A device for implantation in a subject, comprising:

a first member including first extension members and a first contact section;

a second member including second extension members and a second contact section; and

a main body rotatably coupled to the first and second members and including at least one drive component and a delivery instrument interface configured to be releasably coupled to a delivery instrument such that operation of the delivery instrument by a user causes rotation of the first extension members and the first contact section relative to the main body and/or rotation of the second extension members and the second contact section relative to the main body such that the first and second members move from an undeployed configuration to a deployed configuration, wherein the delivery instrument interface moves in response to operation of the delivery instrument to controllably move the at least one drive component to gradually drive the first and/or second members toward the deployed configuration, wherein the first and second extension members are positioned to be inserted between a first spinous process and a second spinous process when in the undeployed configuration, wherein the first extension members are spaced apart from one another so as to be positioned on opposite sides of the first spinous process when the first member is in the deployed configuration and when the first contact section is positioned at the interspinous space, and wherein the second extension members are spaced apart to be positioned on opposite sides of the second spinous process when the second member is in the deployed configuration and when the second contact section is positioned at the interspinous space.

2. The device of claim 1, further comprising a pin rotatably coupling the first member to the main body, and wherein the first extension members and the first contact section form a U-shaped portion of the first member.

3. The device of claim 1, wherein

the first extension members extend in an anterior direction relative to the main body when the first member is in the undeployed configuration, and wherein the first extension members extend in a superior direction relative to the main body when the first member is in the deployed configuration, and

the second extension members extend in an anterior direction relative to the main body when the second member is in the undeployed configuration, and wherein the second extension members extend in an inferior direction relative to the main body when the second member is in the deployed configuration.

4. The device of claim 3, wherein the first and second extension members and a long axis of the main body extend in an anterior-to-posterior direction relative to the subject'"'"'s spine when the first and second members are in the undeployed configuration and the main body is at an interspinous space between the first and second spinous processes.

5. The device of claim 1, wherein the first contact section is saddle shaped.

6. The device of claim 1, wherein at least a portion of the main body is positioned directly between the first and second contact sections when the first and second members are in the deployed configuration.

7. The device of claim 1, wherein the first extension members and the second extension members extend in opposite directions when the first and second members are in the undeployed configuration.

8. The device of claim 1, wherein the first member is rotatable about a first axis of rotation relative to the main body, wherein the second member is rotatable about a second axis of rotation relative to the main body, and wherein the first and second axes of rotation are substantially parallel to one another.

9. The device of claim 8, wherein the first and second axes are substantially perpendicular to a sagittal plane of the device.

10. The device of claim 1, wherein

each of the first extension members defines a first long axis that

extends in an anterior direction relative to the subject when the first member is in the undeployed configuration and the main body is at the interspinous space, and

extends in a superior direction relative to the subject when the first member is in the deployed configuration and the main body is at the interspinous space;

and

each of the second extension members defines a second long axis that

extends in the anterior direction relative to the subject when the second member is in the undeployed configuration, and

extends in the inferior direction relative to the subject when the second member is in the deployed configuration.

11. A device for implantation in a subject, comprising:

a first member including a first U-shaped portion with first ends spaced apart to receive a superior spinous process therebetween;

a second member including a second U-shaped portion with second ends spaced apart to receive an inferior spinous process therebetween; and

a main body rotatably coupled to the first and second members such that the first and second U-shaped portions receive respective superior and inferior spinous processes when the main body rotates the first and second members from an undeployed configuration for delivering the first and second members into an interspinous space to a deployed configuration for engaging an inferior region of the superior spinous process and a superior region of the inferior spinous process, wherein the interspinous space is directly between the inferior region and the superior region, wherein the main body includes at least one drive component and a delivery instrument interface configured to couple to a delivery instrument, and wherein the delivery instrument interface moves in response to operation of the delivery instrument to controllably move the at least one drive component to gradually drive the first and second members toward the deployed configuration.

12. The device of claim 11, wherein a portion of the main body is positioned directly between saddle shaped portions of the first and second U-shaped positions when the first and second members are in the deployed configuration.

13. The device of claim 11, wherein the first member traverses an arc of about 90 degrees when the first member moves from the undeployed configuration to the deployed configuration.

14. The device of claim 11, wherein at least one of the first and second members is positioned substantially perpendicular to a longitudinal axis of the main body when the least one of the first and second members is in the deployed configuration.

15. The device of claim 11, wherein the first and second members rotate relative to the main body in response to an actuator moving through the main body.

16. The device of claim 11, wherein the first U-shaped portion includes

a pair of elongate arms including the first ends that define an opening for receiving the superior spinous process, and

a contact region extending between the elongate arms.

17. The device of claim 11, wherein at least one of the first and second members is positioned substantially perpendicular to a longitudinal axis of the main body when the at least one of the first and second members is in the deployed configuration.