Expandable spinal implants

• US 10,441,430 B2
• Filed: 07/24/2017
• Issued: 10/15/2019
• Est. Priority Date: 07/24/2017
• Status: Active Grant

• Current Assignee: K2M, Inc (Stryker Corporation)
• Original Assignee: K2M, Inc (Stryker Corporation)
• Inventors: Ludwig, Steven, Dhupar, Scott, Bianco, Sabatino, Abbed, Khalid, Doppenberg, Egon, Moore, Jennifer, Donohoe, John, Jones, Scott
• Primary Examiner(s): Sevilla, Christian A
• Application Number:
  US15/657,796
• Publication Number:
  US 20190021868A1
• Time in Patent Office: 813 Days
• 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 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• 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 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30515 using a locking wedge or block
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/443 having two transversal endplates and at least one intermediate component
• 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

Abstract

A spinal implant has proximal and distal regions, and includes upper and lower bodies. A proximal adjustment assembly is disposed between the upper and lower bodies in the proximal region of the spinal implant and is adjustably coupled to the upper and lower bodies, and a distal adjustment assembly is disposed between the upper and lower bodies in the distal region of the spinal implant and is adjustably coupled to the upper and lower bodies. The proximal and distal adjustment assemblies are independently movable with respect to each other, both concurrently and alternately, to change a vertical height of at least one of the proximal or distal regions of the spinal implant. A set screw is removably disposed within the proximal region of the spinal implant to lock the vertical height of the proximal and distal regions of the spinal implant.

Claims

1. A spinal implant having a proximal region and a distal region, the spinal implant comprising:

an upper body including an outer surface and an inner surface;

a lower body including an outer surface and an inner surface, the inner surfaces of the upper and lower bodies disposed in opposed relation relative to each other;

a proximal adjustment assembly disposed between the upper and lower bodies in the proximal region of the spinal implant and adjustably coupled to the upper and lower bodies;

a distal adjustment assembly disposed between the upper and lower bodies in the distal region of the spinal implant and adjustably coupled to the upper and lower bodies, wherein the proximal and distal adjustment assemblies are independently movable, both concurrently and alternately, to change a vertical height of at least one of the proximal region or the distal region of the spinal implant; and

a set screw removably disposed within the proximal region of the spinal implant to lock the vertical height of the proximal and distal regions of the spinal implant.

2. The spinal implant according to claim 1, wherein the distal adjustment assembly includes a pivot linkage assembly including an upper pivot linkage pivotably connected to the inner surface of the upper body, a lower pivot linkage pivotably connected to the inner surface of the lower body, and a connector linkage pivotably connected to the upper and lower pivot linkages such that longitudinal movement of the connector linkage causes a corresponding movement of the upper and lower pivot linkages with respect to each other to change the vertical height of the distal region of the spinal implant.

3. The spinal implant according to claim 2, wherein the distal adjustment assembly includes a threaded post including an elongated threaded body extending through the proximal adjustment assembly and a distal end disposed within a recess defined in the connector linkage such that longitudinal translation of the threaded post effects movement of the pivot linkage assembly.

4. The spinal implant according to claim 3, wherein the distal adjustment assembly includes an expander including a body portion defining a cavity therein and a distal end including a double ramped inner surface, wherein the pivot linkage assembly extends through the cavity of the expander such that the upper and lower pivot linkages contact the double ramped inner surface of the expander when moved by the threaded post.

5. The spinal implant according to claim 4, wherein the expander includes a shaft extending proximally from the body portion, the shaft including a threaded opening defined therein, and wherein the elongated threaded body of the threaded post is threadably engaged with the threaded opening of the shaft and axially movable therethrough into the cavity of the expander.

6. The spinal implant according to claim 3, wherein each of the inner surfaces of the upper and lower bodies includes a pair of proximal fins defining angled slots therethrough, and wherein the proximal adjustment assembly includes:

a linkage body including distal holes defined through lateral sides thereof; and

a first set of pins disposed within the distal holes of the linkage body and into the angled slots of the upper and lower bodies,

such that movement of the linkage body causes the first set of pins to translate within the angled slots to change the vertical height of the proximal region of the spinal implant.

7. The spinal implant according to claim 6, wherein the proximal adjustment assembly includes a flange nut having a threaded opening defined therethrough that is threadably engaged with the threaded post of the distal adjustment assembly, and the linkage body includes a recess disposed between proximal and distal portions thereof in which the flange nut is disposed, and wherein axial movement of the flange nut along the threaded post effects movement of the linkage body.

8. The spinal implant according to claim 7, wherein the proximal portion of the linkage body includes a threaded inner surface, and the set screw includes a threaded outer surface threadably engageable with the threaded inner surface of the linkage body to prevent the threaded post and the flange nut from moving proximally with respect to the linkage body.

9. The spinal implant according to claim 6, wherein the pair of proximal fins of the upper and lower bodies defines vertical slots therethrough, and wherein the proximal adjustment assembly includes a coupler that includes a pair of nubs extending from lateral sides thereof that is slidably disposed within the vertical slots of the upper and lower bodies.

10. The spinal implant according to claim 1, wherein at least one of the outer surfaces of the upper body or the lower body includes a plurality of tapered ridges.

11. A system comprising:

a spinal implant having a proximal region and a distal region, the spinal implant comprising;

an upper body including an outer surface and an inner surface;

a lower body including an outer surface and an inner surface, the inner surfaces of the upper and lower bodies disposed in opposed relation relative to each other;

a proximal adjustment assembly disposed between the upper and lower bodies in the proximal region of the spinal implant and adjustably coupled to the upper and lower bodies; and

a distal adjustment assembly disposed between the upper and lower bodies in the distal region of the spinal implant and adjustably coupled to the upper and lower bodies, wherein the proximal and distal adjustment assemblies are independently movable, both concurrently and alternately, to change a vertical height of at least one of the proximal region or the distal region of the spinal implant; and

an insertion instrument comprising;

a body portion including an elongated shaft extending along a longitudinal axis; and

a connector assembly including connector arms pivotably secured to opposed sides of the elongated shaft, the connector arms configured to engage an outer surface of the spinal implant.

12. The system according to claim 11, wherein the proximal adjustment assembly of the spinal implant includes a linkage body pivotably coupled to the upper and lower bodies, the linkage body including proximal cavities defined in lateral sides thereof, and each connector arm of the insertion instrument includes an engagement feature radially movable relative to the longitudinal axis such that the engagement features are movable in and out of engagement with the proximal cavities of the spinal implant.

13. The system according to claim 12, wherein each engagement feature is disposed on a distal portion of the respective connector arm and the connector assembly includes connector plates slidably disposed over the connector arms such that when the connector plates are disposed in a proximal position, the distal portions of the connector arms extend radially outwardly relative to the longitudinal axis and when the connector plates are disposed in a distal position, the distal portions of the connector arms are substantially aligned with the longitudinal axis.

14. The system according to claim 13, wherein the body portion of the insertion instrument includes elongated rails slidably disposed on the opposed sides of the elongated shaft, the elongated rails coupled to the connector plates of the connector assembly such that longitudinal movement of the elongated rails causes a corresponding longitudinal movement of the connector plates between the proximal and distal positions.

15. The system according to claim 14, wherein the body portion of the insertion instrument includes a rotation knob threadably engaged with a proximal portion of the elongated shaft and coupled to proximal ends of the elongated rails such that rotation of the rotation knob causes longitudinal movement of the elongated rails.

16. The system according to claim 11, further including a driving instrument positionable through a lumen defined through the insertion instrument, the driving instrument configured to actuate the proximal and distal adjustment assemblies.

17. The system according to claim 11, further including a set screw driver positionable through a lumen defined through the insertion instrument, the set screw driver configured to engage a set screw with the spinal implant to lock a position of the spinal implant.

18. A system comprising:

a spinal implant having a proximal region and a distal region, the spinal implant comprising;

an upper body including an outer surface and an inner surface;

a lower body including an outer surface and an inner surface, the inner surfaces of the upper and lower bodies disposed in opposed relation relative to each other;

a proximal adjustment assembly disposed between the upper and lower bodies in the proximal region of the spinal implant and adjustably coupled to the upper and lower bodies; and

a distal adjustment assembly disposed between the upper and lower bodies in the distal region of the spinal implant and adjustably coupled to the upper and lower bodies, wherein the proximal and distal adjustment assemblies are independently movable, both concurrently and alternately, to change a vertical height of at least one of the proximal region or the distal region of the spinal implant; and

a driving instrument including;

an outer shaft including a distal end configured to actuate the proximal adjustment assembly;

a distal inner shaft disposed within the outer shaft and including a distal end configured to actuate the distal adjustment assembly; and

a proximal shaft assembly including a proximal outer shaft, a proximal inner shaft disposed within the proximal outer shaft, and an adjustment knob for adjusting the position of the proximal inner shaft relative to the proximal outer shaft, a distal portion of the proximal outer shaft disposed within a proximal portion of the distal inner shaft, the adjustment knob movable between a height position configured to allow for simultaneous actuation of the proximal and distal adjustment assemblies, a proximal position configured to allow for actuation of only the proximal adjustment assembly, and a distal position configured to allow for actuation of only the distal adjustment assembly.

19. The system according to claim 18, wherein the proximal adjustment assembly of the spinal implant includes a flange nut that is longitudinally movable to drive a change in the vertical height of the proximal region of the spinal implant, and the distal adjustment assembly of the spinal implant includes a threaded post that is longitudinally movable to drive a change in the vertical height of the distal region of the spinal implant, the flange nut including a threaded opening defined therethrough that is threadably engaged with the threaded post.

20. The system according to claim 19, wherein the outer shaft of the driving instrument includes an open distal tip having an inner surface configured to engage an outer surface of the flange nut, and the distal inner shaft of the driving instrument including a distal tip configured to engage a recessed proximal end of the threaded post.

21. A method of implanting a spinal implant into a disc space between adjacent vertebral bodies, the method comprising:

inserting a spinal implant that is releasably attached to a distal end of an insertion instrument into a disc space, the spinal implant including;

an upper body including an outer surface and an inner surface;

a lower body including an outer surface and an inner surface, the inner surfaces of the upper and lower bodies disposed in opposed relation relative to each other;

a proximal adjustment assembly disposed between the upper and lower bodies in the proximal region of the spinal implant and adjustably coupled to the upper and lower bodies; and

a distal adjustment assembly disposed between the upper and lower bodies in the distal region of the spinal implant and adjustably coupled to the upper and lower bodies, wherein the proximal and distal adjustment assemblies are independently movable, both concurrently and alternately, to change a vertical height of at least one of the proximal region or the distal region of the spinal implant;

inserting a driving instrument into a lumen defined through the insertion instrument and into engagement with the spinal implant, the driving instrument including;

an outer shaft including a distal end configured to actuate the proximal adjustment assembly;

a distal inner shaft disposed within the outer shaft and including a distal end configured to actuate the distal adjustment assembly; and

a proximal shaft assembly including a proximal outer shaft, a proximal inner shaft disposed within the proximal outer shaft, and an adjustment knob for adjusting the position of the proximal inner shaft relative to the proximal outer shaft, a distal portion of the proximal outer shaft disposed within a proximal portion of the distal inner shaft, the adjustment knob movable between a height position configured to allow for simultaneous actuation of the proximal and distal adjustment assemblies, a proximal position configured to allow for actuation of only the proximal adjustment assembly, and a distal position configured to allow for actuation of only the distal adjustment assembly; and

adjusting at least one of the proximal or distal adjustment assemblies of the spinal implant with the driving instrument.

22. The method according to claim 21, further comprising attaching the spinal implant to the distal end of the insertion instrument with the outer surfaces of the upper and lower bodies substantially parallel to each other.

23. The method according to claim 21, wherein adjusting at least one of the proximal or distal adjustment assemblies includes setting the driving instrument to the height position to actuate both the proximal and distal adjustment assemblies such that the upper and lower bodies of the spinal implant are expanded while maintaining the upper and lower bodies in substantially parallel relation to each other until the spinal implant engages the vertebral bodies.

24. The method according to claim 22, further comprising individually actuating at least one of the proximal or distal adjustment assemblies to adjust the height of at least one of the proximal or distal regions of the spinal implant to accommodate lordosis.

25. The method according to claim 21, wherein adjusting at least one of the proximal or distal adjustment assemblies includes setting the driving instrument to the proximal or distal position to individually actuate the proximal or distal adjustment assembly.

26. The method according to claim 21, further comprising locking the position of the spinal implant with a set screw.

27. The method according to claim 21, further comprising adjusting the vertical height of at least one of the proximal or distal regions of the spinal implant prior to inserting the spinal implant into the disc space.