Expandable trial with telescopic stabilizers

• US 10,322,014 B2
• Filed: 01/31/2018
• Issued: 06/18/2019
• Est. Priority Date: 09/09/2013
• Status: Active Grant

• Current Assignee: Integrity Implants, Inc.
• Original Assignee: Integrity Implants, Inc.
• Inventors: To, John, Rao, Praveen Gopal
• Primary Examiner(s): Beccia, Christopher J
• Application Number:
  US15/885,183
• Publication Number:
  US 20180221175A1
• Time in Patent Office: 503 Days
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/4425 made of articulated components
• 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 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30154 square
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices

Abstract

Systems and methods for distracting an intervertebral disc space are provided. The systems use an expandable trial with telescopic stabilizers. The systems and methods of distracting an intervertebral space are provided in a manner that addresses the problem of subsidence. The method includes inserting the trial into the intervertebral space in a collapsed state and, once inserted, the trial is then used for distracting the intervertebral space using an expansion that includes a first stage and a second stage. The first stage includes expanding the trial laterally toward the peripheral zones of the top vertebral plate and the bottom vertebral plate, and the second stage includes expanding the trial vertically to distract the intervertebral space.

Claims

1. A method of distracting an intervertebral space, the method comprising:

using an expandable trial for an intervertebral space, the trial including

an expandable shell having a proximal region with an end, a mid-region, a distal region with an end, and a lumen;

the proximal region having a slider-guide flexibly attached to an expandable head in the distal region, the expandable head having

a top subhead and a bottom subhead operably connected through a plurality of telescopic stabilizers, each telescopic stabilizer having

a linear member; and

,

a guide;

wherein, the linear member slidably translates with it'"'"'s respective guide to stabilize and/or align the relationship between the top subhead and the bottom subhead when expanding the expandable shell from a collapsed state to an expanded state and collapsing the expandable shell from the expanded state to the collapsed state;

creating a point of entry into an intervertebral disc, the intervertebral disc having a nucleus pulposus surrounded by an annulus fibrosis, and the point of entry having the maximum lateral dimension created through the annulus fibrosis;

removing the nucleus pulposus from within the intervertebral disc through the point of entry, leaving the intervertebral space for expansion of the head of the trial within the annulus fibrosis, the intervertebral space having the top vertebral plate and the bottom vertebral plate;

inserting the head in the collapsed state through the point of entry into the intervertebral space; and

,

distracting the intervertebral space, the distracting including slidably translating the telescopic stabilizer in the expansion of the head to the expanded state.

2. The method of claim 1, further comprising retaining the trial with a retractable retention plunger and retracting the plunger to expand the trial.

3. The method of claim 1, wherein the lateral dimension of the point of entry ranges from about 5 mm to about 18 mm.

4. The method of claim 1, wherein the distracting includes selecting an amount of vertical expansion.

5. The method of claim 1, wherein the distracting includes selecting a vertical expansion component that includes a vertical-expansion wedge with angle ⊖

_V ranging from 30°

to 50°

.

6. The method of claim 4, wherein the distracting includes selecting a vertical expansion component that includes a vertical-expansion wedge with angle ⊖

_V ranging from 10°

to 90°

.

7. The method of claim 1, wherein for the inserting and the distracting, the head has

a transverse cross-section in the collapsed state having a maximum dimension ranging from 5 mm to 18 mm for placing the frame in an intervertebral space through an annular opening for expansion in the intervertebral space;

and,

a transverse cross-section in the expanded state having a maximum dimension ranging from 6.5 to 28 mm in the intervertebral space.

8. The method of claim 1, wherein for the inserting and the distracting, the linear member comprises a rod, and the guide is configured complementary to the rod.

9. The method of claim 1, wherein for the inserting and the distracting, the proximal end of a shim is configured to receive an axial proximal-to-distal force through an actuation bar for an axial translation of the shim into the shell, the actuation bar having a proximal portion with a proximal end, a distal portion with a distal end, and configured to transfer the axial proximal-to-distal force to the shim through the slider-guide.

10. The method of claim 1, wherein for the inserting and the distracting, the trial has at least 2 telescopic stabilizers.

11. The method of claim 1, wherein the using of the expandable trial includes inducing the vertical expansion of the head in the intervertebral space with a vertical expansion component.

12. The method of claim 11, wherein the inducing of the vertical expansion includes transferring an axial proximal-to-distal force from an actuation screw that is operably attached to the proximal end of the actuation bar to an actuation component having a proximal end and a distal end that is operably connected to the vertical expansion component.