Minimally invasive expanding spacer and method

• US 7,087,055 B2
• Filed: 06/25/2002
• Issued: 08/08/2006
• Est. Priority Date: 06/25/2002
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Sherman, Michael C., Foley, Kevin T., Lim, Roy
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US10/178,960
• Publication Number:
  US 20030236520A1
• Time in Patent Office: 1,505 Days
• Field of Search: 606/61, 606/69, 606/70, 606/71, 606/90, 606/105, 606/198, 606/205, 606/207, 606/208, 623/17.16, 433/7, 33302-304, 335/12, 336/13, 336/45, 600/222, 600/224
• US Class Current: 606/99
• 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 17/2804 with two or more pivotal connections A61B17/29 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30624 Hinged joint, e.g. with transverse axle restricting the movement

Abstract

A minimaly invasive spacer for positioning between vertebral members. The spacer is adjustable between a first orientation having a reduced size to facilitate insertion between the vertebral members. A second orientation has an enlarged size for contacting the vertebral members. The spacer includes linkages that are attached to a pair of plates. A pull arm is operatively connected to the linkages for adjusting the spacer from the first orientation to the second orientation. A delivery device is attached to the spacer for insertion between the vertebral members. In one embodiment, the delivery device is detachable to be removed from the spacer once positioned between the vertebral members. Methods of using the spacer include positioning the spacer between the vertebral members while in the first orientation. The spacer is then enlarged to the second orientation, and the delivery device is removed with only the spacer remaining within the patient.

Claims

1. A device for spacing vertebral members comprising:

a plurality of linkages each comprising an elongated shape with a first end and a second end, at least one end having teeth;

a pull arm pivotally connected to the first end of each of the plurality of linkages; and

a first plate connected to the second end of at least one of the plurality of linkages and a second plate connected to the second end of at least one of the plurality of linkages;

the pull arm being positioned in a first orientation with the linkages having a first link angle, and a second orientation with the plurality of linkages having a second link angle, with the second link angle being greater than the first link angle.

2. The device of claim 1, wherein the device has a substantially bullet-shape in the first orientation with a narrow first end and a wider second end.

3. The device of claim 1, wherein the first plate and the second plate are symmetric about a centerline in both the first orientation and the second orientation.

4. The device of claim 3, wherein the pair of plates are parallel in both the first orientation and the second orientation.

5. The device of claim 1, wherein the first link angle is greater than 0°

.

6. The device of claim 1, wherein one of the first plate and the second plate is positioned a greater distance outward from a centerline in the second orientation than in the first orientation.

7. The device of claim 1, wherein the pull arm comprises a rounded distal end.

8. The device of claim 1, wherein the pull arm comprises an elongated slot for receiving a pin for attaching the first end of at least one of the plurality of linkages.

9. The device of claim 1, wherein teeth are positioned at the second end of each of the plurality of linkages.

10. The device of claim 9, wherein the teeth are positioned at the first end of each of the plurality of linkages.

11. The device of claim 1, wherein the pull arm is positioned between at least two of the plurality of linkages.

12. The device of claim 1, further comprising an elongated delivery device to position the device between the vertebral members.

13. The device of claim 12, wherein the elongated delivery device comprises a distal section and a proximal section with the pull arm being operatively connected to the proximal section and the distal section being separable from the proximal section.

14. The device of claim 13, further comprising a scroll positioned between the distal section and the proximal section, the scroll being movably attached to the proximal section.

15. The device of claim 12, wherein the elongated delivery device is detachable from the device.

16. The device of claim 1, further comprising a force mechanism operatively attached to the pull arm to apply an axial force, the force mechanism comprising a locking mechanism to attach to the elongated delivery device.

17. The device of claim 1, wherein outer surfaces of the first and second plates extend beyond the plurality of linkages to contact the vertebral members.

18. The device of claim 1, wherein the first plate and the second plate are each wider than the plurality of linkages.

19. The device of claim 1, wherein a distal end of the pull arm is positioned further inward relative to the first and second plates in the second orientation than in the first orientation.

20. A device for spacing vertebral members comprising:

a first plate and a second plate;

a pull arm; and

a first linkage and a second linkage each having a first end and a second end, each of the first ends being pivotally connected to the pull arm, the second end of the first linkage being pivotally connected to the first plate, and the second end of the second linkage pivotally connected to the second plate;

the first linkage and the second linkage being positionable between a first orientation and a second orientation, a distance between the second ends being less in the first orientation than in the second orientation;

wherein each of the first linkage and the second linkage comprise teeth on the first ends that mate together when moving between the first orientation and the second orientation.

21. The device of claim 20, wherein the first linkage and the second linkage overlap in the first orientation.

22. The device of claim 21, wherein the first linkage and the second linkage each include recessed sections that mate together in the first orientation.

23. The device of claim 20, wherein the pull arm is positioned parallel with a device centerline.

24. The device of claim 20, wherein the first and second linkages are positioned completely between the first and second plates in both the first and second orientations.

25. A device for spacing vertebral members comprising:

a first plate and a second plate;

a first linkage pair pivotally attached to the first plate and the second plate;

a second linkage pair pivotally attached to the first plate and the second plate;

when a distance between the first plate and the second plate changes, a first toothed end of the first linkage pair attached to the first plate mates with a first toothed end of the second linkage pair, and a second toothed end of the first linkage pair attached to the second plate mates with a second toothed end of the second linkage pair when a distance between the first plate and the second plate increases.

26. The device of claim 25, wherein each of the first linkage pair and the second linkage pair comprises a first link member and a second link member pivotally connected together.

27. The device of claim 25, wherein a total of four linkage pairs are positioned between the first plate and the second plate.

28. A device for spacing vertebral members comprising:

a first plate;

a second plate;

a pull arm positioned between the first plate and the second plate;

a first linkage pair and a second linkage pair each comprising a first end connected to the first plate, a second end connected to the second plate, the first linkage pair connected to the pull arm at a first connection point, and the second linkage pair connected to the pull arm at a second connection point;

the device positionable between a first orientation having a first height and a second orientation having a second height greater than the first height, a distance between the first connection point and the second connection point being greater in the first orientation than in the second orientation;

the first ends each having teeth that mate together as the device moves between the first orientation and the second orientation.

29. The device of claim 28, wherein the pull arm further comprises an elongated slot sized to receive a pin to attach the second linkage pair to the pull arm, the pin positioned at a first position within the elongated slot at the first orientation, and a second position within the elongated slot at the second orientation.

30. The device of claim 29, wherein the first linkage pair is statically connected to the pull arm with the first connection point being at the same position relative to the pull arm at the first orientation and the second orientation.

31. A method of spacing vertebral members comprising the steps of:

inserting a spacer in a first orientation with a first height between the vertebral members;

applying an axial force in a proximal direction to a pull arm to axially move the pull arm; and

pivoting linkages attached to the pull arm and increasing the spacer to a second height larger than the first height.

32. The method of claim 31, wherein the step of pivoting the linkages comprises moving the linkages from a first link angle to a second larger link angle.

33. The method of claim 31, wherein the step of pivoting the linkages causes one of first and second plates to move outward from a centerline of the spacer to increase the spacer from the first height to the second height with first and second plates contacting the vertebral members.

34. The method of claim 31, further comprising contacting the vertebral members with first and second plates in the second orientation as the linkages are positioned away from the vertebral members.

35. The method of claim 31, further comprising moving a pull arm in a proximal direction relative to a first plate during movement from the first orientation to the second orientation.

36. A method of spacing vertebral members comprising the steps of:

positioning a spacer between the vertebral members, the spacer being in a first orientation with a first height and a linkage having a first link angle; and

expanding the spacer from the first orientation to a second orientation with a second height greater than the first height and a second link angle greater than the first link angle;

with a distance between first attachment points between first and second linkages with a pull arm being greater in the first orientation than in the second orientation, and second attachment points between the first and second linkages with a plate being equal in both the first and second orientations.

37. A method of spacing vertebral members comprising the steps of:

inserting a spacer between the vertebral members;

applying an axial force to move a pull arm in a proximal direction;

pivoting at least one pair of linkages from a first orientation having a first link angle to a second orientation having a second link angle greater than the first link angle; and

moving a pair of plates from the first orientation sized to fit between the vertebral members to a second orientation having a height greater than the first orientation to contact the pair of plates against the vertebral members.

38. The method of claim 37, further comprising mating together teeth positioned at ends of the one pair of linkages when pivoting from the first orientation to the second orientation.

39. The method of claim 37, further comprising determining a distance between vertebral members based on the positioning of the pair of plates in the second orientation.

40. A method of spacing vertebral members comprising the steps of:

inserting a spacer between the vertebral members, the spacer being in a closed orientation and having a closed height;

applying a first deployment force and moving an arm in a proximal direction to move the spacer from the closed orientation to a first opened orientation and increasing the spacer to a first height larger than the closed height; and

applying a second deployment force less than the first deployment force and moving the spacer from the first opened orientation to a second opened orientation and increasing the spacer to a second height greater than the first height.

41. The method of claim 40, further comprising increasing a link angle from a first angle to a greater second angle when moving the spacer from the closed orientation to the second opened orientation.

42. The method of claim 41, further comprising positioning the first angle to be greater than zero degrees.

43. A method of spacing vertebral members comprising the steps of:

positioning a spacer between the vertebral members;

applying a deployment force in a proximal direction;

pivoting a pair of linkages each attached to a pull arm;

separating a pair of plates from a first orientation having a first height to a second height greater than the first height; and

applying a disc space load to the vertebral members, the disc space load being greater at the second height than at the first height.

44. The method of claim 43, wherein the step of applying the deployment force comprises applying an axial force to a pull arm that is operatively connected to the pair of linkages.

45. The method of claim 43, further comprising pivoting the pair of linkages from a first link angle in the first orientation to a second link angle in the second orientation, the second link angle being greater than the first link angle.

46. The method of claim 43, further comprising maintaining the pair of linkages between the pair of plates in both first and second orientations.