Apparatus and method of spinal implant and fusion

• US 9,427,264 B2
• Filed: 10/06/2014
• Issued: 08/30/2016
• Est. Priority Date: 12/05/2008
• Status: Active Grant

• Current Assignee: Jeffrey Kleiner
• Original Assignee: Jeffrey Kleiner
• Inventors: Kleiner, Jeffrey
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US14/507,367
• Publication Number:
  US 20150025575A1
• Time in Patent Office: 694 Days
• Field of Search: 606/60, 606246-249, 606/279, 606/301, 606/304, 606/306, 606 75- 78, 606/99, 606/104, 606/86.A, 623 1711- 1716
• US Class Current: 1/1
• 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 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7076 for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
• CPC Class Codes: A61B 17/7082 for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws driving other bone screws A61B17/8875
• CPC Class Codes: A61B 17/846 Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface A61B17/72, A61B17/86 take precedence
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/3433 with different outer diameters of the cannula
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61F 2/30724 Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30622 Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30754 : Implants for interposition between two natural articular surfaces
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61L 24/046 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 24/12 : Ionomer cements, e.g. glass-ionomer cements A61L24/043 takes precedence
• CPC Class Codes: A61L 2400/06 : Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

An apparatus and method of performing a minimally invasive posterior spine fusion. More specifically an apparatus with a handle and a forked head on the distal end of the handle is used to grasp implant material and introduce the material to an implant site. The shaft of the apparatus is shaped so as to allow the affixation of a drill guide and drill while simultaneously holding the implant material in the implant site. After removal of the boring tools and assembly of the fusing element, the apparatus can be selectively removed from the implant site. A method of achieving facet joint fusion with near simultaneous fixation is also disclosed.

Claims

1. A system for minimally invasively accessing a spinal facet joint space to deliver an implant to the spinal facet joint space, the system comprising:

a tool comprising a proximal portion including a handle, a distal portion generally opposite the proximal portion comprising an elongated shaft having a first end connected to the handle and a distal end, said elongated shaft having at least one of ;

an angle between said handle and said distal end, said angle being approximately 45 degrees; and

a generally cylindrical body, and having a hollow portion about a longitudinal axis that is in communication with at least one aperture located at the distal end of the elongated shaft, said shaft having a head, said head having a forked end with a first static tine and a second static tine, said first tine having a free standing distal end, and a second tine having a free standing distal end, wherein the distal end of the first tine and the distal end of the second tine are not connected, wherein said first and second tines are of the same length, said forked end adapted for directly grasping an implantable material; and

wherein the first and second tines engage lateral slots on each side of the implantable material wherein the implantable material is devoid of holes, is sized and shaped to be complementary with said forked ends and wherein the length of said implantable material is substantially encompassed on said each side by the first tine and the second tine, and said lateral slots are adapted to secure the implantable material in said forked end while permitting said implantable material to be dislodged when said implantable material is inset in said facet joint space; and

wherein the first tine and the second tine each have a proximal-distal length adapted to extend substantially across the spinal facet joint space when the first tine and the second tine are positioned in the spinal facet joint space.

2. The system as set forth in claim 1, wherein the head serves as a spacer between the spinal facet joint space.

3. The system as set forth in claim 1, wherein the system further includes a device to inject the implantable material into the spinal facet joint space.

4. The system as set forth in claim 1, wherein the head is selectively detached from the distal end of the elongated shaft and remains in the spinal facet joint space.

5. The system as set forth in claim 4, wherein the head provides mechanical support to the spinal facet joint space.

6. The system as set forth in claim 4, wherein the head is connected to the shaft of by connecting means, said connecting means configured to selectively attach and remove the head from the shaft.

7. The system as set forth in claim 1, wherein implantable material is positioned between the first tine and the second tine.

8. The system as set forth in claim 1, wherein said head is composed of bioactive implantable material.

9. The system as set forth in claim 1, wherein the implantable material measures about 3×

9×

6 mm in size.

10. The system as set forth in claim 1, wherein said implantable material is bioactive.

11. The system of claim 1, wherein when the implantable material is positioned at the forked end and is generally aligned with the distal end of the first tine and the distal end of the second tine.

12. The system of claim 1, wherein the implantable material has a distal edge, a proximal edge, and two parallel lateral edges, the proximal edge adapted to be received by the forked end of the apparatus between the first and second tines.

21. The system as set forth in claim 1, wherein the head comprises variably rigid material designed to allow bioactive material to be frictionally held in place.

22. The system as set forth in claim 1, wherein the head is made of a semi-flexible material adapted to grasp the bioactive material.

23. The system as set forth in claim 1, wherein an interior surface of the tines of the forked head have a groove corresponding to the outer surface of a bioactive material.

24. The system as set forth in claim 1, wherein the forked head has a groove that corresponds to a track of a bioactive material, said groove helping to secure the bioactive material to the forked end.

25. The system as set forth in claim 1, wherein the forked end is devoid of a mechanism that causes the tines to move together.

13. A system for treating a spinal facet joint, the system comprising:

a) a spinal facet implant configured for minimally invasive insertion into the spinal facet joint; and

b) a delivery assembly comprising;

i) a tool configured for minimally invasively accessing the spinal facet joint comprising an elongated shaft having a distal end and having at least one of;

an angle between said handle and said distal end, said angle being approximately 45 degrees; and

a generally cylindrical body and having a hollow portion about a longitudinal axis that is in communication with at least one aperture located at the distal end of the elongated shaft, said shaft having a head, said head having a forked end adapted for grasping said spinal facet implant, said forked end comprising a first static tine and a second static tine, said first tine having a free standing distal end, and a second tine having a free standing distal end, wherein the distal end of the first tine and the distal end of the second tine are not connected, and collectively define a distal tip of the tool and wherein the first and second tines directly engage lateral slots on the side of the spinal facet implant wherein the implantable material is devoid of holes, is sized and shaped to be complementary with said forked ends and wherein the length of said implantable material is substantially encompassed on said each side by the first tine and the second tine, and said lateral slots are adapted to secure the implantable material in said forked end while permitting said implantable material to be dislodged when said implantable material is inset in said facet joint space;

ii) a plunger distally displaceable within a channel and along a longitudinal axis of the tool,

wherein the system is configured such that distal displacement of the plunger along the longitudinal axis causes the spinal facet implant to distally displace between the first tine and the second tine for implantation of the spinal facet implant into the spinal facet joint and wherein the first tine and the second tine are fixedly connected to said head in an immovable manner.

14. The system of claim 13, wherein the plunger pushes the head out of engagement with the elongated shaft.

15. The system according to claim 13, wherein said elongated shaft is angled at 45°

.

16. The system according to claim 13, wherein said elongated shaft is comprised of a flexible shaft.

17. The system according to claim 13 wherein the head is connected to the shaft by connecting means, the connecting means comprising means for selectively attaching and removing the head from the shaft.

18. A method of treating a spinal facet joint, the method comprising:

inserting into the spinal facet joint, via a minimally invasive approach, a pair of tines of a forked distal region of an implant delivery tool, the tines being offset from each other transverse to a longitudinal axis of the tool, the pair of tines comprising a first static tine having a free standing distal end, and a second static tine having a free standing distal end, wherein the distal end of the first tine and the distal end of the second tine are not connected and are of the same length, said forked end adapted for receiving a spinal facet implant wherein the first and second tines directly engage lateral slots on the side of the spinal facet implant, said implant delivery tool having an elongated shaft with at least one of;

an angle between said handle and said distal end, said angle being approximately 45 degrees; and

a generally cylindrical body and having a hollow portion about a longitudinal axis of the generally cylindrical body that is in communication with at least one aperture located at a distal end of the elongated shaft wherein the implantable material is devoid of holes, is sized and shaped to be complementary with said forked ends and wherein the length of said implantable material is substantially encompassed on said each side by the first tine and the second tine, and said lateral slots are adapted to secure the implantable material in said forked end while permitting said implantable material to be dislodged when said implantable material is inset in said facet joint space; and

distally displacing a plunger within the hollow portion of the tool to cause a distal end of the plunger to distally displace said spinal facet implant located between the pair of tines, the distal displacing of the plunger taking place while the tines are located within the spinal facet joint.

19. The method of claim 18, wherein the spinal facet implant comprises allograft.

20. The method of claim 18, wherein the spinal implant is configured to fuse the spinal facet joint, said spinal implant being generally planar, and includes a malleable material that conforms to the facet joint upon implantation.

26. A system for minimally invasively accessing a spinal facet joint space to deliver an implant to the spinal facet joint space, the system comprising:

a tool comprising a proximal portion including a handle, a distal portion generally opposite the proximal portion comprising an elongated shaft having a first end connected to the handle and a distal end, said elongated shaft having at least one of;

an angle between said handle and said distal end, said angle being approximately 45 degrees; and

a generally cylindrical body and having a hollow portion about a longitudinal axis that is in communication with at least one aperture located at the distal end of the elongated shaft, said shaft having a head, said head having a forked end with a first static tine and a second static tine, said first tine having a free standing distal end, and a second tine having a free standing distal end, wherein the distal end of the first tine and the distal end of the second tine are not connected, and wherein said first and second tines are of the same length, said forked end adapted for directly grasping an implantable material, wherein the first and second tines engage lateral slots on the side of the implantable material; and

wherein the first tine and the second tine each have a proximal-distal length adapted to extend substantially across the spinal facet joint space when the first tine and the second tine are positioned in the spinal facet joint space;

wherein when the implantable material is positioned at the forked end and is generally aligned with the distal end of the first tine and the distal end of the second tine;

wherein the implantable material has a distal edge, a proximal edge, and two parallel lateral edges, the proximal edge adapted to be received by the forked end between the first and second tines and wherein the length of said implantable material is substantially encompassed on said each side by the first tine and the second tine; and

wherein the forked end of the apparatus between the first and second tines is devoid of a mechanism that causes the tines to move together.