SPINAL JOINT IMPLANT DELIVERY DEVICE AND SYSTEM

• US 20180303631A1
• Filed: 10/13/2016
• Published: 10/25/2018
• Est. Priority Date: 10/13/2015
• Status: Active Grant

• Current Assignee: Providence Medical Technology, Inc.
• Original Assignee: Providence Medical Technology, Inc.
• Inventors: Phan, Christopher U., Tanaka, Shigeru, Liou, Edward, Smith, Jeffrey D., Schneider, Scott
• Granted Patent: US 10,682,243 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8042 the additional component being a cover over the screw head
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 17/8888 at its central region
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30517 using a locking plate
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/308 : oblong
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• 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: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2002/4687 : Mechanical guides for implantation instruments

Abstract

Provided herein are devices, systems, apparatus and methods for accessing the cervical spine via an anterior approach and implanting a spinal fixation member between two vertebrae of the cervical spine in the disc or intervertebral joint space, such as in an ACDF procedure. The delivery device includes a distal end that can be anchored to the spinal fixation member. Once anchored to the spinal fixation member, the delivery device is operable to both advance and attach the spinal fixation member within a cervical disc joint space.

Claims

1. An apparatus for guiding a fixation member to a cervical disc joint space in a spine in an ACDF procedure, the apparatus comprising:

a delivery device comprising;

an anchor shaft comprising a central lumen defining a longitudinal axis, a distal portion and a proximal portion extending from the distal portion;

a guide member operably associated with the anchor shaft, the guide member defining a first lumen coaxial with the central lumen, two angled lumen offset from the first lumen and at least one fixation member engagement feature; and

a fixation member having at least one threaded opening and at least one guide member engagement feature such that when the guide member engagement feature receives the fixation member engagement feature, the engagement hinders rotation of the fixation member relative to the guide member.

2. The apparatus of claim 1, further comprising a rod member having at least one threaded end extending at least partially through the central lumen of the anchor shaft to releasably engage the threaded opening of the fixation member.

3. The apparatus of claim 2, further comprising a handle, the handle operably coupled to the proximal portion of the anchor shaft and rotatably coupled to the rod, wherein rotation of the rod releasably engages the rod with the fixation member.

4. The apparatus of any of the preceding claims, wherein the at least one fixation member engagement feature includes at least one, and preferably two slots.

5. The apparatus of any of the preceding claims, wherein the first angled lumen defines a first trajectory that is angled relative to the longitudinal axis and the second angled lumen defines a second trajectory that is angled relative to the longitudinal axis

6. The apparatus of claim 5, wherein the first trajectory is different from the second trajectory.

7. The apparatus of any of the preceding claims, wherein the fixation member further comprises two angled threaded apertures offset from the at least one threaded opening, the two angled threaded apertures coextensive or coaxial with a respective angled lumen of the guide member when the guide member and the fixation member are engaged.

8. The apparatus of any of the preceding claims, wherein when the guide member and the fixation member are engaged, the opening of the fixation member is coextensive or coaxial with the central lumen of the anchor shaft.

9. The apparatus of any of the preceding claims, wherein a surface of the guide member and a surface of the fixation member abut each other.

10. The apparatus of claim 1, wherein the guide member is slidably coupled with anchor shaft.

11. A system for guiding and securing a fixation member to a cervical disc joint space in a spine in an ACDF procedure, the system comprising:

a fixation member delivery device including;

an anchor shaft comprising a central lumen defining a longitudinal axis, a distal portion and a proximal portion extending from the distal portion; and

a guide member operably associated with the anchor shaft, the guide member defining a first lumen coaxial with the central lumen, two angled lumen offset from the first lumen and at least one fixation member engagement feature; and

a fixation member having at least one threaded opening and at least one guide member engagement feature such that when the guide member engagement feature receives the fixation member engagement feature, the engagement hinders rotation of the fixation member relative to the guide member; and

a drive member having a first end operably associated with the guide member adjacent the anchor shaft.

14. The system of any of claims 11-14, wherein the fixation member further comprises two angled threaded apertures offset from the at least one threaded opening, the two angled threaded apertures coextensive or coaxial with a respective angled lumen of the guide member when the guide member and the fixation member are engaged.

15. The system of claim 14 wherein the first trajectory guides a first fastener to a superior vertebral surface and the second trajectory guides a second fastener to an inferior vertebral surface.

16. The system of claims of any of claims 11-15 further comprising at least one fastener, the at least one fastener received in one of the two angled threaded apertures of the fixation member to secure the fixation member to a vertebral surface.

17. The system of claim 16, wherein the fastener is an anti-backout screw or a self-locking screw, with an interference thread at the head of the screw.

18. The system of any of claims 11-17, wherein the first end of the drive member includes a coupling that permits the drive member to rotate and/or articulate with a fastener at a desired angle to deploy the fastener at a desired angle with minimal tissue retraction.

19. The system of claim 18, wherein the coupling is selected from a group consisting of a universal joint, a coil spring, or a relief cut tube portion.

12. The system of claim 12 wherein the device further comprises a rod member having at least one threaded end extending at least partially through the central lumen of the anchor shaft to releasably engage the threaded opening of the fixation member.

13. The system of claim 13 wherein the device further comprises a handle, the handle operably coupled to the proximal portion of the anchor shaft and rotatably coupled to the rod, wherein rotation of the rod releasably engages the rod with the fixation member.

20. A method of implanting a spinal fixation implant, the method comprising:

advancing a delivery apparatus into a disc joint space between two adjacent vertebrae in an ACDF procedure, the delivery apparatus comprising;

an anchor shaft comprising a central lumen defining a longitudinal axis, a distal portion and a proximal portion extending from the distal portion;

a guide member operably associated with the anchor shaft, the guide member defining a first lumen coaxial with the central lumen, two angled lumen offset from the first lumen and at least one fixation member engagement feature; and

a fixation member having at least one threaded opening and at least one guide member engagement feature such that when the guide member engagement feature receives the fixation member engagement feature, the engagement hinders rotation of the fixation member relative to the guide member;

advancing a drill/drive member adjacent the delivery apparatus, the drill/drive member having a fastener releasably attached to a first end of the drill/drive member; and

advancing the fastener through the one of the two angled lumen of the guide member to attach the fixation member to at least one of the two adjacent vertebrae.

21. The method of claim 20 wherein the first end of the drill/drive member includes a coupling that permits the drill/drive member to rotate and/or articulate with a fastener at a desired angle to deploy the fastener at a desired angle with minimal tissue retraction.

22. The method of claim 21 wherein the coupling is selected from a group consisting of a universal joint, a coil spring, or a relief cut tube portion.

23. The method of claim 20, wherein the fastener is an anti-backout screw or a self-locking screw, with an interference thread at the head of the screw.

24. A delivery device for guiding a fixation member to a spine, the delivery device comprising:

an anchor shaft having a distal portion and a proximal portion extending from the distal portion, the distal portion being keyed or threaded to anchor onto the fixation member; and

a guide member operably associated with the anchor shaft.

25. The delivery device of claim 24, wherein the guide member is slidably coupled with anchor shaft.

26. The delivery device of any of claims 24 and 25, wherein the anchor shaft is a cannulated tube or solid rod.

27. The delivery device of any of claim 24, further comprising a screw guide operably connected to the anchor shaft.

28. The delivery device of claim 27, wherein the screw guide is formed monolithically with the guide member.

29. The delivery device of any of claims 27 and 28, wherein the screw guide includes one or more formed or removable angled lumen to set a trajectory for a bone screw.

30. The delivery device of any of claims 24-25, wherein the guide member is a double or single cannulated member slidably coupled with the anchor shaft.

31. The delivery device of any of claims 24-25, wherein the guide member is a guidewire extending adjacent the anchor shaft and configured to anchor onto the fixation member.

32. The delivery device of any of claims 24-31, wherein the guide member defines at least one drill/drive path therein.

33. A system for guiding and securing a fixation member to a spine, the system comprising:

an intervertebral implant delivery device including;

an anchor shaft having a distal portion and a proximal portion extending from the distal portion, the distal portion being releasably affixed to anchor onto the fixation member; and

a guide member operably connected to the anchor shaft; and

a drill/driver member having a first end and slidably coupled with the guide member adjacent the anchor shaft.

34. The system of claim 33, further comprising a screw guide for supporting the drill/drive member and a bone screw connected to the drill or driver member at a desired angle for insertion of the bone screw into the fixation member.

35. The system of any of claims 33 and 34, wherein the guide member is a single or double cannulated member slidably coupled with the anchor shaft and the drill/drive member.

36. The system of claim 35, wherein the drill/drive member is releasably coupled with the guide member.

37. The system of any of claim 33-35, wherein the anchor shaft is a cannulated tube and the system further comprises a guidewire slidably received within the cannulated anchor shaft.

38. The system of claim 37, wherein the guidewire is operable to guide and position a cannulated screw onto the fixation member.

39. The system of any of claim 33, wherein the drill/drive member is cannulated to receive a shaft therein to preset an angle of the first end of the drill/drive member for bone screw insertion into the fixation member.

40. The system of any of claims 33-39, wherein the first end of the drill/drive member includes a coupling that permits the drill/drive member to rotate and articulate with a bone screw at a desired angle.

41. The system of claim 40, wherein the coupling is selected from a group consisting of a universal joint, a coil spring, or a relief cut tube portion.

42. A method of implanting a spinal fixation implant, the method comprising:

advancing a delivery device into a joint between two adjacent vertebrae, the delivery device including a fixation member releasably attached to a distal end thereto;

advancing a drill/drive member adjacent the delivery device; and

attaching the fixation member to at least one of the two adjacent vertebrae.

43. The method of claim 42, further comprising guiding a bone screw releasably attached to the drill/drive member into the fixation member at a desired angle.