Facet joint implants and delivery tools

• US 20090312763A1
• Filed: 06/05/2009
• Published: 12/17/2009
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Providence Medical Technology, Inc.
• Original Assignee: Providence Medical Technology, Inc.
• Inventors: McCormack, Bruce M., Smith, Jeffrey D.
• Granted Patent: US 8,361,152 B2
• Time in Patent Office: Days
• US Class Current: 606/83
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1735 for rasps or chisels
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7074 Tools specially adapted for spinal fixation operations other than for bone removal or filler handling A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 2017/00424 ergonomic, e.g. fitting in fist
• CPC Class Codes: A61B 2017/00429 with a roughened portion
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/320028 with reciprocating movements
• CPC Class Codes: A61B 2090/031 torque limiting
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• 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 2/4455 : 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 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30168 : L-shaped
• CPC Class Codes: A61F 2002/30176 : V-shaped
• CPC Class Codes: A61F 2002/30266 : wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30289 : helically-coiled
• CPC Class Codes: A61F 2002/30378 : Spherically-shaped protrusion and recess
• CPC Class Codes: A61F 2002/30405 : made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30471 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30484 : Mechanically expandable devices located on the first prosthetic part for locking into or onto the second prosthetic part
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30523 : by means of meshing gear teeth
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30733 : Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: H04L 45/00 : Routing or path finding of packets in data switching networks routing or path finding in wireless networks H04W40/00
• CPC Class Codes: H04L 45/02 : Topology update or discovery
• CPC Class Codes: H04L 45/22 : Alternate routing
• CPC Class Codes: H04L 45/28 : using route fault recovery
• CPC Class Codes: H04W 28/04 : Error control

Abstract

A spinal joint distraction system is disclosed and may include a delivery device, a driver assembly, and an internal actuator, where the driver assembly is adapted to be hold an implant and be sleevably inserted into the delivery device and the internal actuator is adapted to advance an implant distractor to distract the implant, the system also including an implant, a chisel, an injector, a gripping tool, and a dilator set. Several embodiments of an implant are disclosed as well a method of placing an implant.

Claims

1. A spinal joint distraction system comprising:

a delivery device including;

a tubular shaft;

a receiving assembly positioned on a proximal end of the tubular shaft and including a seating cavity; and

a pair of forks extending from a distal end of the tubular shaft, the forks adapted to penetrate a facet joint;

a chisel including a shaft with a chamfered tip, the chisel being adapted for slidable insertion through the delivery device;

a decorticator sleevably positioned on the tubular shaft of the delivery device, the decorticator comprising;

a tubular shaft portion with a chamfered distal end;

a plurality of serrated teeth at the distal tip of the chamfered end;

a beveled edge extending along the periphery of the chamfered distal end; and

a handle positioned on the proximal end of the tubular shaft portion, the handle having a bore adapted to receive a gripping tool and a threaded bore for receiving a set screw;

a driver assembly adapted for slidable insertion through the delivery device, the driver assembly comprising;

an implant shaft;

a handle positioned on the proximal end of the implant shaft; and

implant holding arms extending from the distal end of the implant shaft;

an internal actuator adapted for slidable insertion through the driver assembly and further adapted to advance an implant distractor, the internal actuator comprising;

a longitudinal shaft;

a handle positioned on the proximal end of the longitudinal shaft and adapted to rotatably advance the implant distractor; and

an internal rod including an engagement feature adapted to secure the implant distractor; and

an injector adapted for slidable insertion through the delivery device, the injector comprising;

a longitudinal delivery shaft;

a seating feature positioned around the shaft; and

a plunger adapted to pass through the longitudinal delivery shaft causing ejection of material from the distal end of the longitudinal delivery shaft.

2. The system of claim 1, wherein the implant holding arms of the driver assembly include an engagement feature for engaging a lateral portion of an implant.

3. The system of claim 2, wherein the engagement feature includes a tab structure.

4. The system of claim 2, wherein the engagement feature includes a bull nose feature adapted to engage a U-shaped slot.

5. The system of claim 1, wherein the internal actuator is rotatably engaged with the implant distractor via the internal rod.

6. The system of claim 1, wherein the engagement feature of the internal rod is a collet.

7. The system of claim 1, wherein the driver assembly further comprises a necked down portion adapted to seat within the seating cavity of the delivery device.

8. The system of claim 1, wherein the injector further comprises a necked down portion adapted to seat within the seating cavity of the delivery device.

9. The system of claim 1, wherein the chisel includes a longitudinal lumen.

10. The system of claim 1 further comprising a gripping tool adapted to engage a bore on the chisel or the decorticator.

11. A spinal joint distraction system comprising:

a delivery device with a decorticator sleevably positioned thereon;

a chisel adapted for insertion through the delivery device;

a driver assembly adapted for insertion through the delivery device and further adapted to hold an implant;

an internal actuator adapted for insertion through the driver assembly and adapted to deliver and advance an implant distractor thereby distracting the implant; and

an injector adapted for insertion through the delivery device and further adapted to deliver flowable material to or around the joint.

12. The system of claim 11, wherein the chisel comprises:

a shaft;

a chamfered tip at the distal end of the shaft;

a coped end at the proximal end of the shaft; and

a horizontal bore passing through the distal end of the shaft, the bore adapted to receive a gripping tool.

13. The system of claim 12, wherein the chamfered tip has a roughened surface for decorticating inner surfaces of the joint.

14. The system of claim 13, wherein the chamfered tip has a length from approximately 11 mm to approximately 17 mm.

15. The system of claim 11, wherein the delivery device comprises:

a tubular shaft;

a receiving assembly positioned on a proximal end of the tubular shaft and including a seating cavity; and

a pair of forks extending from a distal end of the tubular shaft, the forks adapted to penetrate a facet joint.

16. The system of claim 15, wherein the tubular shaft includes a circumferential groove just distal to the receiving assembly.

17. The system of claim 15, wherein the forks have a roughened surface for decorticating the inner surfaces of the joint and for anchoring the delivery device in the joint.

18. The system of claim 17, wherein the forks have a length from approximately 11 mm to approximately 17 mm.

19. The system of claim 15, wherein the receiving assembly includes a bore in alignment with the tubular shaft, the bore having a tapered entrance.

20. The system of claim 11, wherein the decorticator includes a handle with a bore adapted to receiving a gripping tool.

21. The system of claim 20, wherein the handle further comprises a threaded bore for receiving a set screw.

22. The system of claim 11, wherein the decorticator includes a tubular shaft portion with a chamfered and beveled distal end and further includes serrated teeth on the distal tip of the distal end.

23. The system of claim 11, wherein the internal actuator includes a handle with a recessed button.

24. The system of claim 23, wherein the handle of the internal actuator includes a biasing mechanism adapted to resist depressing the button.

25. The system of claim 23, wherein the internal actuator includes an internal rod with a collet for holding the implant distractor.

26. The system of claim 11, further comprising a dilator set.

27. The system of claim 26, wherein the dilator set includes a dilator rod and a plurality of dilator sleeves.

28. A spinal distraction implant comprising:

an upper member and a lower member each with a distal end, the distal end of the lower member coupled to the distal end of the upper member; and

an implant distractor adapted to be advanced between the upper and lower member and separate the upper and lower members causing the upper and lower member to pivot relative to one another about their respective distal ends.

29. The implant of claim 28, wherein the upper and lower member each further comprise a threaded slot and the implant distractor comprises a coil shaped thread feature, each of the threaded slots adapted to receive the coil shaped thread feature.

30. The implant of claim 29, wherein the upper and lower member each further comprise a truncated threaded slot and the implant distractor comprises a cross-cut thread for engaging the truncated threaded slot and preventing the implant from backing out.

31. The implant of claim 28, wherein the upper member and the lower member each further comprise an interlocking scissor feature and the upper and lower member are pivotally coupled via their respective interlocking scissor features.

32. The implant of claim 28, wherein the upper member and the lower member each comprise two later edges and a plurality of teeth spaced along the two lateral edges.

33. The implant of claim 28, wherein the upper member and the lower member each comprise a guide feature for receiving and guiding the implant distractor.

34. A spinal distraction implant comprising:

an upper member and a lower member each comprising;

a distal edge, a proximal edge, and two parallel lateral edges, the edges defining a generally rectangular shape;

an inner surface;

an outer surface;

a threaded slot passing through the member from the inner surface to the outer surface;

a truncated threaded slot passing through the member from the inner surface to the outer surface;

a plurality of teeth spaced along the two parallel lateral edges;

a guide feature positioned on the proximal edge; and

an interlocking scissor feature positioned on the distal edge; and

an implant distractor comprising;

a cylindrical body tapering to a point at a distal end;

a coil shaped thread feature having an abrupt proximal end and being interrupted by at least one cross-cut; and

an annular stop ring;

wherein

the upper and lower members are pivotally coupled to one another via their respective interlocking scissor features;

the respective guide features on the upper member and the lower member oppose one another and are adapted to receive and guide the distal end of the implant distractor between the upper and lower members;

the respective threaded slots on the upper and lower member are adapted to receive the coil shaped thread feature; and

the respective truncated threaded slots are adapted to engage the abrupt proximal end or the at least one cross-cut of the coil shaped thread feature.

35. The implant of claim 34, wherein the plurality of teeth have a linearly sloped distal face and a proximal face positioned orthogonally to the respective upper or lower member.

36. The implant of claim 35, wherein the lateral edges of the upper and lower members follow a first radiused curve from the inner surface to the outer surface, wherein the extension of the first radiused curve beyond the outer surface of the upper or lower member defines an outside face of the teeth.

37. The implant of claim 36, wherein an inside face of the teeth is defined by a second radiused curve offset from the first radiused curve such that the plurality of teeth have a substantially constant thickness.

38. The implant of claim 37, wherein the teeth are equally spaced.

39. The implant of claim 34, wherein the implant distractor includes a square proximal end adapted to be received by a collet.

40. The implant of claim 39, wherein the square proximal end further comprises a circumferential groove.

41. The implant of claim 34, wherein the respective guide features each comprise a half-conical feature.

42. The implant of claim 34, wherein the distal edges are further coupled together via a weld.

43. A method of distracting a facet joint of the spine comprising:

dilating a path to a facet joint using a dilator set;

inserting a chisel into the facet joint;

advancing a delivery device over the chisel and inserting forks of the delivery device into the facet joint;

removing the chisel from the joint;

inserting a driver assembly with an implant into the delivery device, seating the driver assembly in the delivery device thereby positioning the implant between the forks of the delivery device and in the facet joint;

inserting an internal actuator into the driver assembly and advancing an implant distractor into the implant thereby distracting the implant;

actuating a button on the internal actuator thereby releasing a grip on the implant distractor and removing the internal actuator and the driver assembly; and

inserting an injector and injecting a flowable material into or around the facet joint.

44. The method of claim 43, wherein advancing the implant distractor includes turning a handle on the internal actuator thereby rotating an internal rod and threadably advancing an implant distractor.

45. A method of distracting a facet joint of the spine comprising:

inserting a chisel into a facet joint to provide initial distraction and decorticate the surface of the joint;

inserting a delivery device over the chisel to maintain the initial distraction;

inserting an implant through the delivery device and into the joint, the implant having teeth adapted to engage the surfaces of the joint;

distracting the implant by advancing an implant distractor, the implant distractor having a coil-shaped thread feature for engaging threaded slots of the implant, the implant distractor further having cross-cut threads for engaging truncated threaded slots on the implant, wherein, advancing the implant distractor includes causing the cross-cut threads to engage the truncated threaded slots and prevent backing out of the implant; and

releasing the implant distractor and removing the delivery device thereby leaving the implant and the implant distractor in place in the joint.

46. A spinal joint distraction system comprising:

a delivery device;

a driver assembly adapted for insertion through the delivery device and further adapted to hold an implant; and

an internal actuator adapted for insertion through the driver assembly and adapted to deliver and advance an implant distractor thereby distracting the implant.

47. A spinal joint distraction system comprising:

a driver assembly adapted to hold an implant; and

an internal actuator adapted for insertion through the driver assembly and adapted to deliver and advance an implant distractor thereby distracting the implant.

48. A spinal joint distraction system comprising:

an implant;

an implant distractor adapted to engage the implant; and

an internal actuator adapted to advance the implant distractor thereby distracting the implant.

49. A method of distracting a facet joint of the spine comprising:

inserting a delivery device into a facet joint;

inserting an implant through the delivery device and into the joint; and

distracting the implant by advancing an implant distractor.

50. A method of distracting a facet joint of the spine comprising:

partially engaging an implant distractor with an implant and engaging the implant distractor with an internal actuator to form an assembly;

inserting the implant portion of the assembly into the facet joint; and

distracting the facet joint.

51. The method of claim 50, wherein distracting facet joint includes actuating the internal actuator which advances the implant distractor.

52. A spinal distraction implant comprising an upper member and a lower member each with a distal end, the distal end of the lower member coupled to the distal end of the upper member, wherein the upper member and lower member each comprise a plurality of threaded slots adapted to engage an implant distractor.

53. The implant of claim 52, wherein the plurality of threaded slots on the upper member or the lower member further comprises a truncated threaded slot.

54. The implant of claim 53, wherein the plurality of threaded slots on the upper member and the lower member each comprises a truncated threaded slot.

55. A spinal distraction implant comprising an upper member and a lower member each with a distal end, the distal end of the lower member including an interlocking scissor feature coupled to a corresponding interlocking scissor feature included on the distal end of the upper member.

56. A spinal distraction implant comprising an upper member and a lower member, each with a distal end, the distal end of the lower member coupled to the distal end of the upper member, wherein the implant is adapted to receive an implant distractor between the upper and lower member.

57. The implant of claim 56, further comprising a guide feature positioned on a proximal end of the upper member and the lower member.

58. A spinal distraction implant comprising an upper member and a lower member, the upper member and lower member coupled at respective distal ends, the upper and lower members being biased toward a position parallel to one another.

59. The spinal distraction implant of claim 58, further comprising an implant distractor adapted to be advanced between the upper and lower member and force the upper and lower member apart and counter to the biased position.