Adjustable implant and insertion tool

• US 9,808,353 B2
• Filed: 06/14/2016
• Issued: 11/07/2017
• Est. Priority Date: 05/20/2013
• Status: Expired

• Current Assignee: K2M, Inc (Stryker Corporation)
• Original Assignee: K2M, Inc (Stryker Corporation)
• Inventors: Suddaby, Loubert, McClintock, Larry
• Primary Examiner(s): JOHANAS, JACQUELINE T
• Application Number:
  US15/181,822
• Publication Number:
  US 20160287403A1
• Time in Patent Office: 511 Days
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/46 Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30281 wedge-shaped
• 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 2002/30522 releasable, e.g. using a releasable ratchet
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/3054 about a connection axis or implantation axis for selecting any one of a plurality of radial orientations between two modular parts, e.g. Morse taper connections, at discrete positions, angular positions or continuous positions
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30568 Multiple spring systems including two or more helical springs
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30624 Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30828 parallel
• CPC Class Codes: A61F 2002/30831 perpendicular with respect to each other
• 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

Abstract

An adjustable spinal implant includes a lower body, an upper body, a locking pawl, and a locking key. The upper body and the lower body are pivotable relative to one another between a collapsed position and an expanded position. The upper body includes a locking flange that extends towards the lower body. The locking pawl is coupled to the lower body and is moveable between a locked position such that the upper and lower bodies are fixed relative to the one another and an unlocked position such that the upper and lower bodies are moveable relative to one another. The locking key is moveable between a locked state such that the locking pawl is fixed in the locked position and an unlocked state wherein the locking pawl is moveable between the locked position and the unlocked position.

Claims

1. A method of expanding an adjustable implant, the method comprising:

positioning the adjustable implant in an intervertebral space, the adjustable implant including;

a lower body;

an upper body including a locking flange extending towards the lower body;

a locking pawl secured to the lower body, the locking pawl preventing the upper body and the lower body from pivoting towards one another; and

a locking key;

pivoting at least one of a distal end of the upper body and a distal end of the lower body away from the distal end of the other one of the upper and lower bodies, the locking pawl ratcheting between a locked position and an unlocked position as one of the upper body and the lower body pivots away from the other one of the upper and lower bodies; and

transitioning the locking key to a locked state to fix the locking pawl in the locked position such that the upper body is fixed relative to the lower body.

2. The method according to claim 1, wherein pivoting the at least one of a distal end of the upper body and a distal end of the lower body away from the distal end of the other one of the upper and lower bodies includes inserting an insertion tool in a passage defined by the upper and lower bodies.

3. The method according to claim 2, further comprising capturing a portion of the lower body within a cutout defined in a distal portion of the insertion tool to longitudinally fix the implant relative to the insertion tool.

4. The method according to claim 2, further comprising translating a spreading rod of the insertion tool into the passage to pivot the distal end of the upper body and the distal end of the lower body away from one another.

5. The method according to claim 4, wherein translating the spreading rod of the insertion tool includes engaging the upper body with a rod guide to pivot the distal end of the upper body and the distal end of the lower body away from one another.

6. The method according to claim 5, wherein translating the spreading rod includes rotating a thumb wheel threadably coupled to a proximal end of the spreading rod.

7. The method according to claim 1, wherein transitioning the locking key to the locked state includes rotating the locking key.

8. The method according to claim 7, wherein rotating the locking key includes engaging a stop pin coupled to the locking pawl with a keyed ring of the locking key to limit rotation of the locking key.

9. The method according to claim 1, further comprising engaging the locking key with a locking rod of an insertion tool and wherein transitioning the locking key to the locked state includes rotating the locking rod to rotate the locking key.

10. The method according to claim 9, wherein engaging the locking key includes receiving a proximal end of the locking key in a recess defined in a distal end of the locking rod.

11. The method according to claim 9, wherein engaging the locking key includes rotating a proximal engagement end of the locking rod disposed within a transport portion of a locking recess defined in an upper section of the insertion tool in a first radial direction and sliding the proximal engagement end of the locking rod within an engagement portion of the locking recess until the locking rod is engaged with the locking key, the engagement portion positioned distal to the transport portion.

12. The method according to claim 11, wherein transitioning the locking key to the locked state includes rotating the locking rod within a locking portion of the locking recess in the first radial direction, the locking portion positioned distal of the engagement portion.

13. The method according to claim 12, further comprising disengaging the locking rod from the proximal end of the locking key by translating the proximal engagement portion proximally within the locking portion of the locking recess.

14. A method of pivoting at least one of an upper body and a lower body of an adjustable implant relative to one another, the method comprising:

pivoting a distal end of at least one of the upper and lower bodies away from one the distal end of the other one of the upper and lower bodies such that a locking pawl, which is in an unlocked state and pivotally secured to the lower body, ratchets against a locking flange of the upper body, the locking flange extending towards the lower body; and

transitioning a locking key having a distal end that extends through the locking pawl and received in the locking flange to a locked position to fix the locking pawl in a locked state such that the upper and lower bodies are fixed relative to one another.

15. The method according to claim 14, wherein pivoting a distal end of at least one of the upper and lower bodies away from one the distal end of the other one of the upper and lower bodies includes inserting an inserter through a passage defined between proximal ends of the upper and lower bodies which are pivotally coupled to one another.

16. The method according to claim 15, further comprising capturing a portion of the lower body within a cutout defined in a distal portion of the insertion tool to longitudinally fix the implant relative to the insertion tool.

17. The method according to claim 14, wherein transitioning the locking key includes rotating the locking key such that the distal end of the locking key prevents the locking pawl from pivoting away from locking flange.

18. The method according to claim 14, further comprising engaging the locking key with a locking rod of an insertion tool, and wherein transitioning the locking key includes rotating the locking rod to affect rotation of the locking key.

19. The method according to claim 14, wherein ratcheting the locking pawl against the locking flange includes positioning a biasing member between the lower body and a biasing finger of the locking pawl to urge the locking pawl towards the locking flange.