IP Library › Granted Patent US 11,806,247
Granted Patent B2
US 11,806,247 · App. 17/676,609 · Granted Nov 7, 2023

Intravertebral implant system and methods of use

Inventors: Randal R. Betz (Bradenton, FL); Dale E. Whipple (Nashua, NH)
Assignee: NOFUSCO CORPORATION
A61F2/4425A61F2002/30405A61F2002/443
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,806,247
App. No.
17/676,609
Granted
Nov 7, 2023
Kind
B2
Abstract

A vertebral implant device is described comprising a wedge, a plate having an external surface configuration and one or more plate tine, a staple having one or more staple tine and a coupling device. The coupling devices is configured to couple the wedge, the plate and the staple whereby when the vertebral implant is secured in a vertebral body, the external surface configuration of the plate alters the relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and alters the alignment of the spine. In some embodiments, plate tines and staple tine are configured to frictionally engage the vertebral body. In some embodiments, the coupling device is a screw and a nut. In some embodiments, interchangeable wedges are used to provide multiple implant device configurations.

Claims (67)

1. A vertebral implant device configured to alter an alignment of a spine, the vertebral implant device comprising:

a wedge having two or more opposing wedge tines;

a plate having an external surface configuration and two or more opposing plate tines;

a coupling device;

a staple having one or more staple tines;

the two or more opposing plate tines and the one or more staple tines are configured to frictionally engage a vertebral body;

the coupling device is configured to couple the wedge, the plate and the staple whereby when the vertebral implant device is secured in the vertebral body, the external surface configuration of the plate is configured to alter a relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and is configured to alter the alignment of the spine; and

the two or more opposing wedge tines are configured to secure the two or more opposing plate tines whereby when the wedge, the plate and the staple are secured in the vertebral body, the two or more opposing wedge tines prevent a change in relative orientation of the two or more opposing plate tines with respect to each other.

2. The vertebral implant device of claim 1 wherein a surface of the two or more opposing wedge tines is configured to engage an external surface of the two or more opposing plate tines to prevent the change in the relative orientation of the two or more opposing plate tines with respect to each other and to prevent an osteotomy in the vertebral body from opening further.

3. The vertebral implant device of claim 1 wherein the two or more opposing wedge tines are configured to provide supplemental fixation of the vertebral implant device to the vertebral body.

4. The vertebral implant device of claim 1 wherein when the wedge, the plate and the staple are secured in the vertebral body, the two or more opposing wedge tines engage the two or more opposing plate tines and secure the relative orientation of the two or more opposing plate tines with respect to each other.

5. The vertebral implant device of claim 1 wherein the staple further comprises a staple swivel coupler configured to allow the staple to articulate relative to the coupling device whereby the staple is configured to better accommodate a sidewall of the vertebral body.

6. The vertebral implant device of claim 1 wherein:

the staple further comprises a staple swivel coupler configured to mate with a coupling device swivel coupler whereby the staple is configured to swivel about a longitudinal axis of the coupling device; and

wherein rotating the coupling device in a first rotation direction rotates the staple to position the one or more staple tines to engage a sidewall of the vertebral body.

7. The vertebral implant device of claim 1 wherein:

the staple further comprises a staple swivel coupler configured to mate with a coupling device swivel coupler whereby the staple is configured to swivel about a longitudinal axis of the coupling device; and

the staple further comprises a proximal end having a radiused corner profile whereby when the coupling device is rotated in a first rotation direction, the proximal end of the staple is rotated in the first rotation direction and is configured to engage the vertebral body to stop a further rotation of the staple.

8. The vertebral implant device of claim 1 wherein:

the plate further comprises a threaded through hole; and

the coupling device further comprises a distal threaded portion configured to engage the threaded through hole of the plate whereby when the coupling device is rotated in a first rotation direction, the coupling device engages the threaded through hole of the plate and adjusts a device length of the vertebral implant device to secure the two or more opposing plate tines and the one or more staple tines to the vertebral body.

9. The vertebral implant device of claim 1 wherein:

the coupling device comprises a screw; and

the screw further comprises a drive portion configured to be engaged by a drive tool whereby when the drive portion is rotated in a first rotation direction by the drive tool, the screw adjusts a device length of the vertebral implant device to secure the two or more opposing plate tines and the one or more staple tines to the vertebral body.

10. The vertebral implant device of claim 1 wherein the coupling device further comprises a distal threaded portion whereby when the coupling device is rotated in a first rotation direction, the coupling device adjusts a device length of the vertebral implant device to secure the vertebral implant device to the vertebral body.

11. The vertebral implant device of claim 1 wherein:

the wedge having a wedge longitudinal angle between a surface plane of a superior surface of the wedge and a surface plane of an inferior surface of the wedge;

the plate having a plate longitudinal angle between a surface plane of a superior surface of the plate and a surface plane of an inferior surface of the plate;

the plate configured to receive the wedge whereby the wedge affects the external surface configuration of the plate to alter the relative orientation of the superior endplate surface plane and the inferior endplate surface plane of the vertebral body and to alter the alignment of the spine; and

one of the plate or the wedge having a transverse angle between their surface planes whereby the transverse angle affects the external surface configuration of the plate to alter the relative orientation of the superior endplate surface plane and the inferior endplate surface plane of the vertebral body to alter the alignment of the spine in both a coronal plane and a sagittal plane.

12. A method to alter an alignment of a spine, the method comprising:

performing an osteotomy procedure through a vertebral body inferior to a pedicle of the vertebral body;

providing a vertebral implant device comprising:

a wedge having two or more opposing wedge tines,

a plate having an external surface configuration and two or more opposing plate tines,

a coupling device,

a staple having one or more staple tines,

the two or more opposing plate tines and the one or more staple tines are configured to frictionally engage a vertebral body,

the coupling device is configured to couple the wedge, the plate and the staple whereby when the vertebral implant device is secured in the vertebral body, the external surface configuration of the plate is configured to alter a relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and is configured to alter the alignment of the spine, and

the two or more opposing wedge tines are configured to secure the two or more opposing plate tines whereby when the wedge, the plate and the staple are secured in the vertebral body, the two or more opposing wedge tines prevent a change in relative orientation of the two or more opposing plate tines with respect to each other;

inserting the plate and the staple into a vertebral opening created by the osteotomy procedure;

deploying the staple whereby the staple extends outside of the vertebral opening;

rotating the coupling device in a first rotation direction to rotate the staple whereby the one or more staple tines are positioned generally perpendicular to the osteotomy to engage a first sidewall of the vertebral body;

tightening the coupling device by rotating the coupling device in the first rotation direction to adjust a device length of the vertebral implant device whereby the one or more staple tines are drawn towards the plate to frictionally engage the first sidewall of the vertebral body;

positioning the wedge over a proximal end of the coupling device and into a cavity of the plate;

coupling a nut on the proximal end of the coupling device and into a bore of the wedge;

tightening the nut on the coupling device whereby the plate is distracted by the wedge as it is drawn into the vertebral body; and

further tightening the nut onto the coupling device whereby the two or more opposing plate tines frictionally engage a second sidewall of the vertebral body and the wedge is secured within the cavity of the plate defining the external surface configuration of the plate to alter the relative orientation of the superior endplate surface plane and the inferior endplate surface plane of the vertebral body and to alter the alignment of the spine.

13. A vertebral implant device configured to alter an alignment of a spine, the vertebral implant device comprising:

a wedge having two or more wedge tines;

a plate having at least two prongs presenting an external surface configuration and two or more plate tines, each plate tine extending from an end of a respective prong away from the other prong;

a coupling device;

the coupling device is configured to couple the wedge and the plate whereby when the vertebral implant device is secured in a vertebral body, the external surface configuration of the plate is configured to alter a relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and is configured to alter the alignment of the spine; and

the two or more wedge tines are configured to secure the two or more plate tines whereby when the wedge and the plate are secured in the vertebral body, an internal surface of each plate tine is configured to face and engage a sidewall of the vertebral body and an internal surface of a respective wedge tine is configured to face and engage an opposite external surface of the plate tine so that the two or more wedge tines prevent a change in relative orientation of the two or more plate tines with respect to each other.

14. The vertebral implant device of claim 13 further comprising:

a staple configured to frictionally engage the vertebral body; and

the coupling device is further configured to couple the wedge, the plate and the staple.

15. The vertebral implant device of claim 13 further comprising:

a staple having one or more staple tines;

the two or more plate tines and the one or more staple tines are configured to frictionally engage the vertebral body; and

the coupling device is further configured to couple the wedge, the plate and the staple whereby when the vertebral implant device is secured in the vertebral body, the external surface configuration of the plate a is configured to alter the relative orientation of the superior endplate surface plane and the inferior endplate surface plane of the vertebral body and is configured to alter the alignment of the spine.

16. The vertebral implant device of claim 13 wherein the internal surface of the two or more wedge tines is configured to engage the external surface of the two or more plate tines to prevent an osteotomy in the vertebral body from opening further.

17. The vertebral implant device of claim 13 wherein:

the wedge having a wedge longitudinal angle between a surface plane of a superior surface of the wedge and a surface plane of an inferior surface of the wedge;

the plate having a plate longitudinal angle between a surface plane of a superior surface of the plate and a surface plane of an inferior surface of the plate;

the plate configured to receive the wedge whereby the wedge affects the external surface configuration of the plate to alter the relative orientation of the superior endplate surface plane and the inferior endplate surface plane of the vertebral body and to alter the alignment of the spine; and

one of the plate or the wedge having a transverse angle between their surface planes whereby the transverse angle affects the external surface configuration of the plate to alter the relative orientation of the superior endplate surface plane and the inferior endplate surface plane of the vertebral body to alter the alignment of the spine in both a coronal plane and a sagittal plane.

Assignments (2)
CHANGE OF NAME Recorded Aug 4, 2023
From: NOFUSCO CORPORATION
To: FOUNDATION SURGICAL GROUP, INC.
Reel/Frame 064502/0748 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2022
From: BETZ, RANDAL R.; WHIPPLE, DALE E.
To: NOFUSCO CORPORATION
Reel/Frame 059058/0978 →
Continuity (4)
Continuation 17347492 · Jun 14, 2021
Continuation PCTUS2021037285 · Jun 14, 2021
Provisional Application 63039242 · Jun 15, 2020
Related Publication 20220211515A1 · Jul 7, 2022
Cited By (1)
US 12,491,078