Systems and methods for posterior dynamic stabilization of the spine

• US 9,283,005 B2
• Filed: 02/25/2013
• Issued: 03/15/2016
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Tebbe, Shawn, Altarac, Moti, Kim, Daniel H.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US13/776,630
• Publication Number:
  US 20130165975A1
• Time in Patent Office: 1,114 Days
• Field of Search: 606247-249
• US Class Current: 1/1
• 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 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• 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 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; 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 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: 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 stabilizing at least one spinal motion segment including a first vertebra having a first spinous process and a second vertebra having a second spinous process, wherein an interspinous space is defined therebetween, comprising:

a. a body defining a passageway and an axis;

b. a superior U-shaped member rotatably coupled to the body near the superior U-shaped member'"'"'s proximal end, the superior U-shaped member having a U-shape at a distal end, and the superior U-shaped member having a tip at the proximal end;

c. an inferior U-shaped member rotatably coupled to the body near the inferior U-shaped member'"'"'s proximal end, the inferior U-shaped member having a U-shape at a distal end, and the inferior U-shaped member having a tip at the proximal end, wherein the tip of the superior U-shaped member and the tip of the inferior U-shaped member are on opposite sides of the axis; and

d. an actuator shaft disposed along the passageway, the actuator shaft having a distal end configured such that distal motion of the actuator shaft along the axis causes the actuator shaft to contact the tips at the proximal ends of the superior and inferior U-shaped members and cause rotation of the superior and inferior U-shaped members;

wherein the superior and inferior U-shaped members are rotatable from an undeployed configuration to a deployed configuration, and wherein the actuator shaft has first and second angled surfaces positioned on opposite sides of the axis such that the tip of the superior U-shaped member lays flat on the first angled surface and the tip of the inferior U-shaped member lays flat on the second angled surface when the superior and inferior U-shaped members are in the deployed configuration, wherein most of the tip of the superior U-shaped member and the first angled surface are on a first side of a sagittal plane defined by the body, wherein most of the tip of the inferior U-shaped member and the second angled surface are located on a second side of the sagittal plane, and wherein the second side is opposite the first side.

2. The device of claim 1, wherein the superior and inferior U-shaped members rotate about 90 degrees from an undeployed to a deployed position.

3. The device of claim 1, wherein the actuator shaft has a distal tip that is in a wedge shape.

4. The device of claim 1, wherein the distal ends of the superior and inferior U-shaped members are structured to receive a spinous process when deployed.

5. The device of claim 1, wherein a proximal end of the body and a proximal end of the actuator shaft are configured to attach to an insertion device.

6. The device of claim 5, wherein the insertion device is structured to attach to the body and the actuator shaft in only one orientation.

7. The device of claim 5, wherein the insertion device is structured to provide relative movement between the body and the actuator shaft.

8. The device of claim 1, wherein the actuator shaft has contact surfaces that are angled with respect to one another and positioned to lay against the tips when the superior and inferior U-shaped members are in a deployed position for holding the first and second spinous processes.

9. A device for stabilizing at least one spinal motion segment including a first vertebra having a first spinous process and a second vertebra having a second spinous process, wherein an interspinous space is defined therebetween, comprising;

a. a body defining a passageway and an axis;

b. a superior U-shaped member rotatably coupled to the body near the superior U-shaped member'"'"'s proximal end, the superior U-shaped member having a U-shape at a distal end, and the superior U-shaped member having a tip at the proximal end;

c. an inferior U-shaped member rotatably coupled to the body near the inferior U-shaped member'"'"'s proximal end, the inferior U-shaped member having a U-shape at a distal end, and the inferior U-shaped member having a tip at the proximal end, wherein the tip of the superior U-shaped member and the tip of the inferior U-shaped member are on opposite sides of the axis;

d. an actuator shaft disposed along the passageway, the actuator shaft having a distal end configured such that distal motion of the actuator shaft along the axis causes the actuator shaft to contract the tips at the proximal ends of the superior and inferior U-shaped members and cause rotation of the superior and inferior U-shaped member, wherein the actuator shaft has a distal tip that is in a fork shape.

10. The device of claim 9, wherein the actuator shaft has a distal tip that is in a split or offset fork shape.

11. A stabilization device, comprising:

a body defining a passageway;

a first member rotatably coupled to the body and including distal first arms and a proximal first contact portion, wherein the proximal first contact portion is located on a first side of the passageway;

a second member rotatably coupled to the body and including distal second arms and a proximal second contact portion, wherein the proximal second contact portion is located on a second side of the passageway opposite the first side; and

an actuator including first and second engagement surfaces, wherein the actuator is movable along the passageway to cause rotation of the first and second members relative to the body such that the first and second members move from an undeployed configuration to a deployed configuration, wherein the first and second contact portions contact the first and second engagement surfaces, respectively, to lock the first and second members in the deployed configuration when a first spinous process of a subject is located between the distal first arms and a second spinous process of the subject is located between the distal second arms,

wherein the body defines a sagittal plane located between the distal first arms and between the distal second arms when the first and second members are in the undeployed and deployed configurations, and wherein the first and second engagement surfaces are positioned on opposite sides of the sagittal plane.

12. The device of claim 11, wherein the actuator has a distal contact portion that is in a wedge shape.

13. The device of claim 11, wherein the proximal first contact portion has a substantially flat first surface that lays generally flat on the first engagement surface when the first member is in the deployed configuration, and wherein the proximal second contact portion has a substantially flat second surface that lays generally flat on the second engagement surface when the second member is in the deployed configuration.

14. The device of claim 11, wherein the actuator is movable in a direction generally parallel to a longitudinal axis of the body to push the first and second members toward the deployed configuration.

15. The device of claim 11, wherein the first and second members hold the first and second spinous processes, respectively, when the first and second members are in the deployed configuration.

16. The device of claim 11, wherein the first and second members are translationally fixed to the body and rotatable about 90 degrees to move from the undeployed configuration to the deployed configuration.

17. A stabilization device, comprising:

a body defining a passageway;

a first member rotatably coupled to the body and including distal first arms and a proximal first contact portion, wherein the proximal first contact portion is located on a first side of the passageway;

a second member rotatably coupled to the body and including distal second arms and a proximal second contact portion, wherein the proximal second contact portion is located on a second side of the passageway opposite the first side; and

an actuator including first and second engagement surfaces, wherein the actuator is movable along the passageway to cause rotation of the first and second members relative to the body such that the first and second members move from an undeployed configuration to a deployed configuration, wherein the first and second contact portions contact the first and second engagement surfaces, respectively, to lock the first and second members in the deployed configuration when a first spinous process of a subject is located between the first arms and a second spinous process of the subject is located between the distal second arms, wherein the actuator has a distal contact portion that is fork shaped.

18. A stabilization device,comprising:

a body defining a passageway;

a first member rotatably coupled to the body and including distal first arms and a proximal first contact portion, wherein the proximal first contact portion is located on a first side of the passageway;

a second member rotatably coupled to the body and including distal second arms and a proximal second contact portion, wherein the proximal second contact portion is located on a second side of the passageway opposite the first side; and

an actuator including first and second engagement surfaces, wherein the actuator is movable along the passageway to cause rotation of the first and second members relative to the body such that the first and second members move from an undeployed configuration to a deployed configuration, wherein the first and second contact portions contact the first and second engagement surfaces, respectively, to lock the first and second members in the deployed configuration when a first spinous process of a subject is located between the distal first arms and a second spinous process of the subject is located between the distal second arms, wherein the body has a longitudinal axis that extends in a posterior-to-anterior direction relative to the subject'"'"'s spine when the first spinous process is located between the distal first arms and when the second spinous process is located between the distal second arms.

19. A device for stabilizing at least one spinal motion segment including a first vertebra having a first spinous process and a second vertebra having a second spinous process, wherein an interspinous space is defined therebetween, comprising:

a body defining a passageway and a longitudinal axis;

a superior U-shaped member rotatably coupled to the body near the superior U-shaped member'"'"'s proximal end, the superior U-shaped member having a U-shape at a distal end, and the superior U-shaped member having a tip at the proximal end;

an inferior U-shaped member rotatably coupled to the body near the inferior U-shaped member'"'"'s proximal end, the inferior U-shaped member having a U-shape at a distal end, and the inferior U-shaped member having a tip at the proximal end, wherein the tip of the superior U-shaped member and the tip of the inferior U-shaped member are on opposite sides of the longitudinal axis; and

an actuator shaft disposed along the passageway, the actuator shaft having a distal end configured such that distal motion of the actuator shaft in the direction of the longitudinal axis causes the actuator shaft to contact the tips at the proximal ends of the superior and inferior U-shaped members and cause rotation of the superior and inferior U-shaped members,

wherein the longitudinal axis extends in a posterior-to-anterior direction relative to the subject'"'"'s spine when the first spinous process is located between first arms of the superior U-shaped member and when the second spinous process is located between second arms of the inferior U-shaped member.

20. The device of claim 19, wherein the distal end of the actuator shaft has angled surfaces that lay flat along the tips of the superior and inferior U-shaped members to keep the superior and inferior U-shaped members in a deployed position.