IP Library Granted Patent US 10,543,024
Granted Patent B2
US 10,543,024 · App. 15/200,459 · Granted Jan 28, 2020

Adjustable spine distraction implant

Inventors: David Lee (Hattiesburg, MS); James Payne (Vancleave, MS)
Assignee: LIFE SPINE, INC.
A61B17/7067A61B17/7068A61B17/7083
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Quick Facts
Patent No.
US 10,543,024
App. No.
15/200,459
Granted
Jan 28, 2020
Kind
B2
Abstract

An adjustable spine distraction implant alleviates pain associated with spinal stenosis and facet arthropathy by expanding the volume and/or cross sectional area in the spinal canal and/or neural foramen. The adjustable implant provides a spinal extension inhibitor. The implant includes elliptical or oval shaped adjustable member or spacer for positioning between and adjustably spacing apart the spinous processes.

Claims (41)

1. An implant positionable between a first spinous process and a second spinous process of a spinal column, the implant comprising:

a central body configured to be inserted between the first spinous process and the second spinous process, the central body comprising:

a housing, and

an elongated member extending from the housing, the elongated member having a longitudinal axis;

a first wing fixed relative to the central body; and

a second wing removably coupled to the elongated member and adjustable along the elongated member, wherein the second wing defines a cutout area configured to receive the elongated member in a transverse direction and the second wing extends only partially about the elongated member;

a threaded fastener extending through the second wing and configured to engage the elongated member to selectively secure the second wing in a desired position, wherein the threaded fastener is threadingly movable between a tightened position configured to maintain the second wing in the desired position and a loosened position configured to enable movement of the second wing relative to the elongated member without threading movement of the threaded fastener;

an adjustment mechanism at least partially located in the housing;

first and second wedging members disposed at least partially within the elongated member and controllable by the adjustment mechanism;

wherein the adjustment mechanism comprises two interfacing geared members operatively coupled to the first and second wedging members such that movement of the at least two interfacing geared members controls expansion and retraction of the first and second wedging members relative to the elongated member in a direction perpendicular to the longitudinal axis to increase or decrease the amount of distraction between the first and second spinous processes.

2. The implant of claim 1 , wherein the elongated member of the central body comprises a cone-shaped insertion guide with lateral truncated sides configured to assist in the insertion of the implant between the first spinous process and the second spinous process.

3. The implant of claim 1 , wherein the elongated member of the central body comprises a pointed and arrow-shaped insertion guide configured to assist in the insertion of the implant between the first spinous process and the second spinous process.

4. The implant of claim 3 , wherein the insertion guide comprises a tip, a first face extending from the tip, and a second face extending from the tip and angled relative to the first face between 25 degrees and 75 degrees.

5. The implant of claim 3 , wherein the insertion guide comprises a tip, a first face extending from the tip, and a second face extending from the tip angled relative to the first face at about 45 degrees.

6. The implant of claim 1 , wherein the first wing includes a first portion and a second portion and both the first portion and the second portion extend from the central body substantially perpendicular to, and offset from, the longitudinal axis.

7. The implant of claim 1 , wherein the second wing comprises a first portion extending from the central body substantially perpendicular to the longitudinal axis, a second portion extending from the central body substantially perpendicular to the longitudinal axis, and a middle section, wherein the first portion, second portion, and middle section define the cutout area.

8. The implant of claim 7 , wherein at least one of the first portion and the second portion of the second wing is offset relative to the longitudinal axis.

9. The implant of claim 7 , wherein the middle section of the second wing comprises a track defining an elongated slot configured to receive the threaded fastener.

10. The implant of claim 9 , wherein the second wing is movable parallel along the elongated member at a distance defined by the engagement of the threaded fastener and elongated slot.

11. The implant of claim 1 , wherein one of the two interfacing geared members has a threaded portion operably connected to the first wedging member and a non-threaded portion which limits the amount of expansion to the first wedging member.

12. The implant of claim 1 , wherein the cutout area is configured to allow the first and second wedging members to move to a position of full distraction when the second wing is coupled to the elongated member.

13. An implant positionable between a first spinous process and a second spinous process of the spinal column, the implant comprising:

a central body configured to be inserted between the first spinous process and the second spinous process, the central body comprising:

a housing having at least a portion of an adjustment mechanism provided therein, the adjustment member including two interfacing geared members, and

an elongated member extending from the housing, the elongated member having a longitudinal axis;

a first wedging member disposed at least partially within the elongated member and controllable by the adjustment mechanism, the first wedging member able to linearly expand and retract relative to the elongated member in a direction perpendicular to the longitudinal axis in order to increase or decrease the amount of distraction between the first and second spinous processes;

a first wing extending from the central body substantially perpendicular to the longitudinal axis; and

a second wing removably coupleable to the elongated member in a direction perpendicular to the longitudinal axis and defining a cutout to receive the elongated member and allow the first wedging member to be positioned in a fully distracted position when the second wing is coupled to the elongated member;

a threaded fastener extending through the second wing and configured to engage the elongated member to selectively secure the second wing in a desired position, wherein the threaded fastener is threadingly movable between a tightened position configured to maintain the second wing in the desired position and a loosened position configured to enable movement of the second wing relative to the elongated member without threading movement of the threaded fastener.

14. The implant of claim 13 , wherein the first wedging member is substantially flush with an exterior surface of the central body when the first wedging member is in a retracted position.

15. The implant of claim 14 , further comprising a second wedging member disposed at least partially within the elongated member and controllable by the adjustment mechanism, the second wedging member able to linearly expand and retract relative to the elongated member in a direction perpendicular to the longitudinal axis and opposite the first wedging member to increase or decrease the amount of distraction between the first and second spinous processes.

16. The implant of claim 15 , wherein the second wedging member is substantially flush with an exterior surface of the central body when the second wedging member is in a retracted position.

17. An implant positionable between a first spinal body and a second spinal body, the implant comprising:

a central body comprising:

a housing;

an adjustment mechanism at least partially located within the housing and including two interfacing geared members;

an elongated member extending from the housing; and

first and second wedging members at least partially disposed within the elongated member and controllable by the adjustment mechanism to increases or decrease an amount of distraction between the first and second spinal bodies;

a first wing fixedly coupled to the central body; and

a second wing removably coupled to the elongated member of the central body and adjustable along a length of the elongated member, the second wing enabling full distraction of the first and second wedging members when the second wing is coupled to the elongated member;

a threaded fastener extending through the second wing and configured to engage the elongated member to selectively secure the second wing in a desired position, wherein the threaded fastener is threadingly movable between a tightened position configured to maintain the second wing in the desired position and a loosened position configured to enable movement of the second wing relative to the elongated member without threading movement of the threaded fastener.

Assignments (9)
RELEASE OF SECURITY INTEREST Recorded Jul 14, 2023
From: ASSOCIATED BANK, NATIONAL ASSOCIATION
To: LIFE SPINE, INC.
Reel/Frame 064275/0446 →
SECURITY INTEREST Recorded Jun 30, 2021
From: LIFE SPINE, INC.
To: ASSOCIATED BANK, NATIONAL ASSOCIATION, AS AGENT
Reel/Frame 056728/0438 →
RELEASE OF SECURITY INTEREST Recorded Dec 23, 2020
From: FIFTH THIRD BANK, NATIONAL ASSOCIATION
To: LIFE SPINE, INC.; GIZMO MEDICAL, LLC
Reel/Frame 054843/0755 →
SECURITY INTEREST Recorded Dec 23, 2020
From: LIFE SPINE, INC.; GIZMO MEDICAL, LLC
To: ST. CLOUD CAPITAL PARTNERS III SBIC, LP
Reel/Frame 054844/0239 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2018
From: LEE, DAVID; PAYNE, JAMES, JR.
To: INNOVATIVE SPINAL DESIGN, LLC
Reel/Frame 047119/0405 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2018
From: INNOVATIVE SPINAL DESIGN, LLC
To: LIFE SPINE, INC.
Reel/Frame 047119/0444 →
CORRECTIVE ASSIGNMENT TO CORRECT THE LEGAL DOCUMENT PREVIOUSLY RECORDED AT REEL: 040497 FRAME: 0926. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT . Recorded Mar 24, 2017
From: GIZMO MEDICAL, LLC; LIFE SPINE, INC.
To: ST CLOUD CAPITAL PARTNERS III SBIC, LP
Reel/Frame 042243/0607 →
CORRECTIVE ASSIGNMENT TO CORRECT THE LEGAL DOCUMENT ATTACHED TO THE FILING PREVIOUSLY RECORDED AT REEL: 040497 FRAME: 0926. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 24, 2017
From: GIZMO MEDIACL, LLC; LIFE SPINE, INC.
To: ST CLOUD CAPITAL PARTNERS III SBIC, LP
Reel/Frame 042084/0917 →
SECURITY INTEREST Recorded Oct 26, 2016
From: GIZMO MEDICAL, LLC; LIFE SPINE, INC.
To: ST CLOUD CAPITAL PARTNERS III SBIC, LP
Reel/Frame 040497/0926 →
Cited By (2)
US 12,201,337 US 12,232,790