SYSTEMS AND METHODS FOR FACET JOINT TREATMENT

• US 20110307061A1
• Filed: 04/11/2011
• Published: 12/15/2011
• Est. Priority Date: 06/15/2010
• Status: Active Grant

• Current Assignee: Surgalign Spine Technologies, Inc. (Surgalign Holdings, Inc.)
• Original Assignee: Zyga Technology, Inc. (Surgalign Holdings, Inc.)
• Inventors: Assell, Robert, Dickhudt, Eugene, Beaubien, Brian
• Granted Patent: US 8,663,293 B2
• Time in Patent Office: Days
• US Class Current: 623/17.11
• 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: 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30321 differing in roughness
• CPC Class Codes: A61F 2002/30322 differing in surface structures
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30685 Means for reducing or preventing the generation of wear particulates
• CPC Class Codes: A61F 2002/30754 Implants for interposition between two natural articular surfaces
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/4629 connected to the endoprosthesis or implant via a threaded connection

Abstract

A system for treating a facet joint of a patient. The facet joint includes a superior articular face and an inferior articular face. The system includes a resurfacing device, an implant insertion tool and a guide cannula. The resurfacing device is positionable between a superior articular face of a facet joint and an inferior articular face of a facet joint. The implant insertion tool is adapted to engage the resurfacing device. The guide cannula has a passage extending therethrough. The guide cannula passage is adapted to receive at least a portion of the resurfacing device and the implant insertion tool.

Claims

1. A system for treating a facet joint of a patient, wherein the facet joint includes a superior articular face and an inferior articular face, wherein the system comprises:

a resurfacing device that is positionable between a superior articular face of a facet joint and an inferior articular face of a facet joint;

an implant insertion tool that is adapted to engage the resurfacing device; and

a guide cannula having an internal passage extending therethrough, wherein the guide cannula passage is adapted to receive at least a portion of the resurfacing device and the implant insertion tool.

2. The system of claim 1, wherein the resurfacing device comprises a first resurfacing portion and a second resurfacing portion.

3. The system of claim 1, wherein the resurfacing device exhibits sufficient flexibility to transition from a relatively flat state to an inserted state in which the resurfacing device substantially matches any multi-planar curvatures of the superior articular face.

4. The system of claim 1, wherein the resurfacing device has a plurality of teeth on at least one surface thereof.

5. The system of claim 1, wherein the resurfacing device comprises a first engagement feature, wherein the implant insertion device comprises a second engagement feature that is capable of mating with the first engagement feature, wherein a force to separate the first engagement feature and the second engagement feature after mating is at least 1 Newton.

6. The system of claim 5, wherein:

the first engagement feature comprises a first aperture region and a second aperture region, wherein the first aperture region intersects an edge of the resurfacing device and wherein the second aperture region is in communication with the first aperture region; and

the second engagement feature comprises a first extension region and a second extension region, wherein the second extension region is attached to the implant insertion device and wherein the first extension region is attached to the second extension region opposite the implant insertion device.

7. The system of claim 1, wherein the implant insertion tool further comprises:

a main portion having a proximal end and a distal end;

a handle portion attached to the main portion proximate the proximal end; and

a shoulder portion extending from at least one of the main portion and the handle portion, wherein the shoulder portion has a width that is greater than a width of the main portion.

8. The system of claim 1, wherein the resurfacing device and the implant insertion tool are slidably mounted with respect to the guide cannula.

9. The system of claim 1, wherein the guide cannula has a concave distal surface that at least partially conforms to an edge of the resurfacing device.

10. The system of claim 1, and further comprising a guide probe assembly that includes a guide probe tip, wherein the guide probe assembly has a width that is smaller than a width of the guide cannula passage and wherein the guide probe assembly has a height that is smaller than a height of the guide cannula passage.

11. The system of claim 10, wherein the guide probe tip is removably mounted to the guide probe assembly.

12. The system of claim 10, wherein a width of the guide probe tip is smaller than the width of the guide probe assembly and wherein a height of the guide probe tip is smaller than the height of the guide probe assembly.

13. The system of claim 1, and further comprising a delivery cannula having an internal passage extending therethrough, wherein the delivery cannula passage is adapted to receive at least a portion of the resurfacing device and the implant insertion tool and wherein the guide cannula passage is adapted to receive the delivery cannula.

14. The system of claim 13, wherein the delivery cannula comprises a pair of leaflets mounted proximate a distal end thereof and wherein the leaflets are fabricated from a resilient material.

15. The system of claim 13, wherein the guide cannula is slidably mounted with respect to the delivery cannula and wherein the resurfacing device and the implant insertion tool are slidably mounted with respect to the delivery cannula.

16. The system of claim 1, and further comprising a retractor tool that comprises:

a first handle section that is capable of engaging the implant insertion tool; and

a second handle section operably connected to the first handle section, wherein the second handle section is capable of engaging the delivery cannula.

17. The system of claim 16, wherein the first handle section is pivotally mounted to the second handle section.

33. The system of claim 12, wherein at least one of the teeth is defined by a leading face and a trailing face, an angle defined by the leading face and a plane of the first major surface being smaller than an angle defined by the trailing face and the plane of the first major surface such that the at least one tooth more overtly resists movement of the corresponding resurfacing body relative to a corresponding facet joint articular face in a first direction as compared to a second, opposite direction.

34. The system of claim 12, wherein the plurality of teeth include:

a first teeth set, each tooth of the first teeth set defining a first angle of extension relative to the second major surface; and

a second teeth set, each tooth of the second teeth set defining an angle of extension relative to the first major surface differing from the first angle of extension.

35. The system of claim 15, wherein each tooth of the first teeth set includes a leading face more proximate the leading end and a trailing face more proximate the trailing end, the leading and trailing faces intersecting at a tip opposite the first major surface, and further wherein a length of the leading face is greater than a length of the trailing face such that the corresponding tooth defines a direction of insertion of the corresponding resurfacing body from the leading end to the trailing end.

36. The system of claim 12, wherein the base web defines a substantially uniform thickness and the plurality of teeth include a first tooth proximate the leading end and a second tooth proximate the trailing end, a height of the first tooth being greater than a height of the second tooth.

18. A system for treating a facet joint of a patient, wherein the facet joint includes a superior articular face and an inferior articular face, wherein the system comprises:

a resurfacing device configured to selectively conform to a shape of at least one of a superior articular face of a facet joint and an inferior articular face of the facet joint, wherein the resurfacing device comprises a first engagement feature; and

an implant insertion device having a second engagement feature that is capable of mating with the first engagement feature, wherein a force to separate the first engagement feature and the second engagement feature after mating is at least 1 Newton.

19. The system of claim 18, wherein the force to separate the first engagement feature and the second engagement feature after mating is between about 1 Newton and about 10 Newtons.

20. The system of claim 18, wherein:

the first engagement feature comprises a first aperture region and a second aperture region, wherein the first aperture region intersects an edge of the resurfacing device and wherein the second aperture region is in communication with the first aperture region; and

the second engagement feature comprises a first extension region and a second extension region, wherein the second extension region is attached to the implant insertion device and wherein the first extension region is attached to the second extension region opposite the implant insertion device.

21. The system of claim 20, wherein a width of the first aperture region is smaller than a width of the second aperture region, wherein a width of the first extension region is larger than a width of the second extension region and wherein the width of the first aperture region is larger than the width of the first extension region.

22. The system of claim 18, wherein the resurfacing device comprises a first resurfacing portion and a second resurfacing portion, wherein the first engagement feature is formed in at least one of the first resurfacing portion and the second resurfacing portion.

23. The system of claim 22, wherein:

the first resurfacing body exhibits sufficient flexibility to transition from a relatively flat state to an inserted state in which the first resurfacing body substantially matches any multi-planar curvatures of the superior articular face; and

the second resurfacing body exhibits sufficient flexibility to transition from a relatively flat state to an inserted state in which the second resurfacing body substantially matches any multi-planar curvatures of the inferior articular face.

24. The system of claim 22, wherein first resurfacing body and the second resurfacing body each comprise a first side and a second side, wherein the first side has a plurality of teeth extending therefrom and wherein the second side is substantially flat.

25. The system of claim 24, wherein the plurality of teeth comprise a first set of teeth, a second set of teeth and a third set of teeth, wherein the first set of teeth are oriented differently than the second set of teeth and the third set of teeth.

26. The system of claim 22, wherein the first resurfacing body and the second resurfacing body each define an anchoring surface and an articulating surface, wherein the system is configured such that upon insertion into a facet joint, the articulating surfaces abut one another in a sliding interface.

27. The system of claim 22, wherein the first resurfacing body and the second resurfacing body each have a circular shape that is defined by a diameter in the range of between about 5 and about 13 millimeters.

28. The system of claim 18, wherein the resurfacing device has a thickness of between about 0.25 and about 4 millimeters.

29. The system of claim 18, wherein the implant insertion device has a thickness that is approximately the same as a thickness of the resurfacing device.

30. The system of claim 18, wherein an end of the implant insertion device includes a concave region that corresponds to at least a portion of an edge of the resurfacing device.

31. The system of claim 18, wherein the resurfacing device exhibits a Conformability Factor of not more than 100 N.

32. The system of claim 18, wherein the resurfacing device is formed of polyetherketone-based plastic.

37. A method of treating a facet joint of a patient, wherein the facet joint includes a superior articular face and an inferior articular face, wherein the method comprises:

securing a resurfacing device to an implant insertion tool by mating a first engagement feature on the resurfacing device with a second engagement feature on the implant insertion tool;

positioning a distal end of a guide cannula proximate the facet joint, wherein the guide cannula has an internal passage extending therethrough;

sliding the resurfacing device through the guide cannula passage until the resurfacing device passes through a distal end of the guide cannula passage; and

exerting a force of at least 1 Newton on the implant insertion tool to separate the first engagement feature and the second engagement feature.

38. The method of claim 37, wherein the resurfacing device comprises a first resurfacing portion and a second resurfacing portion and wherein the first resurfacing portion is shaped similar to the second resurfacing portion.

39. The method of claim 38, wherein the first resurfacing portion and the second resurfacing portion each have a plurality of teeth formed on at least one surface thereof

40. The method of claim 37, wherein the first engagement feature comprises a first aperture region and a second aperture region, wherein the first aperture region intersects an edge of the resurfacing device, wherein the second aperture region is in communication with the first aperture region, wherein the second engagement feature comprises a first extension region and a second extension region, wherein the second extension region is attached to the implant insertion device, wherein the first extension region is attached to the second extension region opposite the implant insertion device, and wherein the first extension region is seated in the second aperture region when the resurfacing device is secured to the implant insertion tool.

41. The method of claim 37, wherein the resurfacing device has a diameter of between about 5 millimeters and about 13 millimeters and a thickness of between about 0.25 millimeters and about 4 millimeters.

42. The method of claim 37, and further comprising defining a joint line in the facet joint by extending a guide probe assembly between the superior articular face and the inferior articular face, wherein the guide probe assembly has a width that is smaller than a width of the guide cannula passage and wherein the guide probe assembly has a height that is smaller than a height of the guide cannula passage.

43. The method of claim 37, wherein sliding the resurfacing device through the guide cannula passage comprises:

sliding the resurfacing device through an internal passage in a delivery cannula, wherein the deliver cannula comprises a pair of leaflets mounted proximate a distal end thereof and wherein the leaflets are fabricated from a resilient material; and

sliding the delivery cannula through the guide cannula passage.

44. The method of claim 37, and further comprising:

engaging the implant insertion tool with a first handle section of a retractor tool;

engaging the delivery cannula with a second handle section of the retractor tool; and

pivoting the first handle section with respect to the second handle section to cause the implant insertion tool to move with respect to the delivery cannula.

45. The method of claim 38, further comprising:

loading the first resurfacing device and the second resurfacing device into an internal passage of a delivery cannula in a stacked arrangement, wherein the delivery cannula assembly has a distal end and defining the delivery cannula passage to be open at the distal end;

slidably disposing an implant insertion tool into the delivery cannula passage, wherein a distal portion of the implant insertion tool abuts the superior resurfacing device and the inferior resurfacing device;

delivering the distal end of the delivery cannula assembly to the facet joint; and

sliding the implant insertion tool distally within the deliver cannula passage to eject the first resurfacing body and the second resurfacing body from the distal end and into the facet joint.

46. The method of claim 45, wherein the first resurfacing body and the second resurfacing body each a first engagement feature and the distal portion of the implant insertion tool has a second engagement feature and wherein the first engagement feature is matable with the second engagement feature.

47. A kit for treating a facet joint of a patient, wherein the facet joint comprises a superior articular face and an inferior articular face, wherein the kit comprises:

a superior resurfacing device configured to selectively transition to a shape that at least partially conforms to a shape of a superior articular face of a facet joint;

an inferior resurfacing device configured to selectively transition to a shape that at least partially conforms to a shape of an inferior articular face of the facet joint, wherein the superior resurfacing device is separate from the inferior resurfacing device; and

an insertion tooling set comprising;

a delivery cannula having an internal passage,

a guide cannula having an internal passage; and

an implant insertion device sized to be slidably received within the delivery cannula passage;

wherein the kit is configured to provide an insertion arrangement in which the superior resurfacing device, the inferior resurfacing device and the implant insertion device are slidably received within the delivery cannula passage, wherein the superior resurfacing device and the inferior resurfacing device are stacked against one another adjacent a distal region of the implant insertion device.

48. The kit of claim 47, wherein at least one of the superior resurfacing device and the inferior resurfacing device comprises a first engagement feature and wherein the implant insertion device comprises a second engagement feature that is capable of mating with the first engagement feature, wherein a force to separate the first engagement feature and the second engagement feature after mating is at least 1 Newton.

49. The kit of claim 47, wherein the superior resurfacing device and the inferior resurfacing device are identical and wherein the superior resurfacing device and the inferior resurfacing device each have a diameter of between about 5 millimeters and about 13 millimeters and a thickness of between about 0.25 millimeters and about 4 millimeters.

50. The kit of claim 47, wherein the superior resurfacing device and the inferior resurfacing device are each formed of a polyetherketone-based material.