IP Library Granted Patent US 8,043,342
Granted Patent B2
US 8,043,342 · App. 11/832,643 · Granted Oct 25, 2011

Craniospinal fusion method and apparatus

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Quick Facts
Patent No.
US 8,043,342
App. No.
11/832,643
Granted
Oct 25, 2011
Kind
B2
Abstract

A method for effecting reduction, stabilization and enhancement of fusion of the human cranio-cervical junction, which may be performed in order to relieve mechanical stresses imparted to the spinal cord and brainstem as a result of an abnormal clivo-axial angle, includes steps of achieving the correct craniocervical relationship, of effecting a fusion of a first portion of a bone forming material based structural member to a human cranium, and effecting fusion of a second portion of the bone forming material based structural member to a least one portion of a human cervical spine. Fusion of the bone forming material based structural member to the human cranium may be promoted through the use of plate member that is shaped to define a graft accommodation space between the plate member and the cranium.

Claims (45)

1. A system for effecting fusion of the human cranio-cervical junction, comprising:

a plate member, said plate member being constructed and arranged to securely position a bone forming material against a human cranium, said plate member having a hole defined therein, wherein said hole is defined by a threaded inner surface of the plate member and is configured as cylindrical through hole;

a rod member;

a triple screw member positioned within said hole, wherein said triple screw member comprises:

a first portion that is inserted within said hole so as to directly contact a surface of said plate member defining said hole, wherein said first portion is threaded and has a cylindrical configuration that engages said threaded inner surface of the plate member;

a second portion comprising a threaded surface capable of engaging the human cranium;

a third portion comprising a threaded surface;

wherein said rod member is received within and positioned through a width of said triple screw member; and

a nut member secured to said third portion, wherein said rod member is secured below said nut member, and whereby said nut member may be tightened in order to fix said rod member and said plate member relative to said triple screw member and the cranium, such that said plate member adjoins said second portion and such that said rod member directly contacts said nut member.

2. A system according to claim 1 , wherein said system comprises two of said rod members, two of said triple screw members and two of said nut members, and wherein said plate member has more than one hole defined therein, whereby attachment between said members and the human cranium may be made in more than one location.

3. A system for effecting fusion of the human cranio-cervical junction, comprising:

surgically implantable instrumentation comprising:

a first support rod;

a second support rod;

a plate member for attaching respective first portions of said first and second support rods to bone, wherein said plate member comprises a hole defined by a threaded inner surface of the plate member, wherein said hole is configured as cylindrical through hole; and

a triple screw attachment means for attaching said first portion of said first support rod and said plate member to said bone without requiring an independent means for attaching said plate member to said first support rod, wherein said triple screw attachment means is inserted within and directly contacts the threaded inner surface of the plate member defining said cylindrical through hole and wherein said triple screw attachment means directly engages said first support rod such that an upper or lower surface of said first support rod is clamped by and directly contacts a surface of said triple screw attachment means, wherein said upper or lower surface faces a direction aligned with a length of said triple screw attachment means, wherein said triple screw attachment means is capable of engaging the bone while contacting the plate member and while said first support rod is clamped by and directly contacts said surface of said triple screw attachment means.

4. A system according to claim 3 , wherein each of said first and second support rods incorporate a βrise to allow the first and second support rods to contact the C1 and C2 laminae.

5. A system according to claim 3 , further comprising a transverse connector that is connected to said first and second support rods for providing lateral stability and spacing to said first and second support rods.

6. A system according to claim 3 , wherein said first and second support rods are configured so that there is substantially no ventral brainstem compression and craniospinal junction deformity is reduced.

7. A system according to claim 3 , wherein an angle between a first portion of said first and second support rods and the second portion of said first and second support rods is about 75° to about 90°.

8. A system according to claim 1 , wherein said second portion comprises a cortical thread, cancellous thread or a rivet-type fixation.

9. A system according to claim 1 , wherein said triple screw member is positioned in a region of said plate member selected from the group consisting of: an upper portion of said plate member, a lower aspect of said plate member, a lateral side of said plate member, and a middle region of said plate member.

10. A system according to claim 1 , wherein an inner surface of said plate member is composed of a material that promotes fusion to bone.

11. A system according to claim 10 , wherein said material comprises a metallurgically bonded porous metal coating that is constructed and arranged to encompass and contain bone forming material.

12. A system according to claim 1 , wherein said plate member comprises a plurality of perforations.

13. A kit for use in effecting fusion of the human cranio-cervical junction, comprising:

a triple screw member adapted to be surgically implanted in bone, wherein said triple screw member comprises:

a first portion sized to engage a plate, wherein said first portion has a cylindrical configuration and a threaded surface adapted for directly contacting a surface of said plate defining a threaded cylindrical through hole;

a second portion comprising a threaded surface for engaging bone;

a third portion comprising a threaded surface on an exterior surface thereof;

a nut member secured to said third portion, whereby said nut member comprises a threaded surface on an interior surface thereof and wherein said nut member is fitted over and screwed onto said third portion in order to secure a rod;

wherein said rod is received within and is positioned through a width of said triple screw member adjoining said first portion and below said nut member, wherein said triple screw member is capable of being surgically implanted in a body and attached to said bone, and wherein said triple screw member is adapted to fix said plate and said rod to said bone, such that said plate adjoins said second portion and such that said rod directly contacts said nut member.

14. A kit according to claim 13 , wherein said threaded surface of said second portion is selected from the group consisting of a cortical thread and cancellous thread.

15. A system according to claim 1 , wherein said a triple screw member consists essentially of said first portion, said second portion, said third portion and said nut member.

16. A system according to claim 1 , wherein said rod member engages said triple screw member between said first portion and said third portion.

17. A system according to claim 1 , wherein said first portion is positioned between said second and third portions such that said plate member is positioned adjacent to said rod member.

18. A kit according to claim 13 , further comprising a tool for securely attaching said triple screw member to said bone, wherein said tool comprises:

a shaft;

a screwdriver blade positioned at a distal end of said shaft; and

a sleeve adapted to be slidably positioned relative to said shaft, wherein said sleeve comprises a internally threaded socket adapted to mate with a threaded exterior surface of said third portion of said triple screw member and wherein said sleeve secures said screwdriver blade to said nut.

19. A kit according to claim 18 , wherein said sleeve is mounted to said shaft so as to be slidably position along the length of said sleeve wherein said sleeve is rotatably fixed relative to said shaft.

20. A system for stabilizing the human cranio-cervical junction, consisting essentially of:

one or more support rods;

one or more plates, wherein said one or more plates have a continuous inner surface with exception of one or more holes formed therein, wherein a surface of said one or more plates that forms said one or more holes are threaded and wherein the continuous inner surface is adapted to be placed against and conform to a contour of a bone surface; and

one or more triple screw attachment means for attaching said one or more support rods and said one or more plates to said bone surface without requiring an independent means for attaching said one or more plates to said one or more support rods, wherein said triple screw attachment means is positioned within one of said one or more holes and wherein said triple screw attachment means directly contacts and engages said one or more support rods and said bone surface wherein said one or more triple screw attachment means includes a first threaded portion that engages said one or more holes, a second threaded portion capable of engaging the human cranium, and a third threaded portion that engages a threaded nut member.

Assignments (10)
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 →
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 →
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 →
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 →
RELEASE OF SECURITY INTEREST Recorded Oct 28, 2016
From: BMO HARRIS BANK N.A.
To: LIFE SPINE, INC.
Reel/Frame 040511/0788 →
SECURITY INTEREST Recorded Oct 26, 2016
From: LIFE SPINE, INC.; GIZMO MEDICAL, LLC
To: MB FINANCIAL BANK, N.A.
Reel/Frame 040491/0791 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2014
From: POLARIS BIOTECHNOLOGY, INC.
To: LIFE SPINE, INC.
Reel/Frame 033921/0104 →
SECURITY INTEREST Recorded Oct 9, 2014
From: POLARIS BIOTECHNOLOGY, INC.
To: LIFE SPINE, INC.
Reel/Frame 033921/0068 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2008
From: HENDERSON, FRASER CUMMINS; NEWMAN, JOHN W.
To: POLARIS BIOTECHNOLOGY, INC.
Reel/Frame 020483/0425 →