IP Library Granted Patent US 9,186,184
Granted Patent B2
US 9,186,184 · App. 13/366,117 · Granted Nov 17, 2015

Spinal fixation system and method

Inventor: Brian P. Janowski (Marquette, MI)
Assignee: PIONEER SURGICAL TECHNOLOGY, INC.
A61B17/7038A61B17/7041A61B17/7082A61B17/7085A61B2019/307
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Quick Facts
Patent No.
US 9,186,184
App. No.
13/366,117
Granted
Nov 17, 2015
Kind
B2
Abstract

A spinal fixation system is provided that, in one form, comprises a pedicle screw assembly having a coupling device with an elongate member for guiding a fixation element, such as a spinal rod, into the coupling device and a lock device for fixing the spinal rod to the coupling device. The pedicle screw assembly may be passed through a small incision and connected to a vertebral bone. By connecting a second pedicle screw assembly to a second vertebral bone, the elongate members of the pedicle screw assemblies provide guideposts for directing the spinal rod subcutaneously between the pedicle screw assemblies and into the coupling devices thereof.

Claims (52)

1. A spinal fixation system for securing a spinal rod relative to a spinal bone, the system comprising:

a bone anchor having a spherical head and a shank depending from the head, the shank extending along a longitudinal axis;

a coupling device for being connected to the bone anchor;

an elongate guide member of the coupling device having a proximal end portion and a distal end portion and a longitudinal axis extending therebetween, the distal end portion including a flexible socket sized for fitting about the spherical head of the bone anchor for forming a ball and socket joint therewith;

an outer surface of the elongate guide member for engaging and guiding the spinal rod;

a body of the coupling device having a through opening sized to receive the proximal end portion of the elongate guide member extending therethrough to permit the body to be advanced along the elongate guide member toward the distal end portion thereof;

an upwardly open seat of the body laterally offset from the shank longitudinal axis and the elongate guide member outer surface to permit the spinal rod to be slid downward along the outer surface and received on the upwardly open seat laterally offset from the shank longitudinal axis;

a cup portion of the body configured to engage and constrict the flexible socket of the elongate guide member about the spherical bone anchor head for fixing the elongate guide member relative to the bone anchor with shifting of the body cup portion distally over the elongate guide member flexible socket;

a locking device having a through opening sized to receive the elongate guide member therethrough and permit the locking device to be guidingly advanced downward along the elongate guide member;

a capture member of the locking device for securing the spinal rod on the body seat; and

mating surfaces of the elongate guide member and the locking device capture member which have a non-rotatable mating fit therebetween with the elongate guide member extending through the locking device through opening.

2. The spinal fixation system of claim 1 wherein the locking device capture member has a through opening sized to receive the elongate guide member therein and the mating surfaces include an outer surface of the elongate guide member and an inner surface of the capture member which defines at least a portion of the capture member through opening.

3. A spinal fixation system for securing a spinal rod to a spinal bone, the system comprising:

a bone anchor having a spherical head portion and a shank portion depending from the spherical head portion;

a body having a seat and a cup portion, the seat configured for receiving a spinal rod;

an elongate actuator having a proximal portion for upstanding from the body configured to permit the spinal rod to travel therealong toward the body and a distal portion having a plurality of flexible fingers defining a socket for receiving the spherical bone anchor head, the body being shiftable relative to the elongate actuator including the proximal and distal portions thereof from an initial position where the body cup portion is not fully seated on the flexible fingers which permits relative movement between the bone anchor and the body toward a locking position where the body cup portion is fully seated on the flexible fingers and constricts the flexible fingers about the spherical bone anchor head which fixes the bone anchor relative to the body;

a locking cap configured to be connected to the elongate actuator to engage the spinal rod and secure the spinal rod on the seat of the body; and

wherein the elongate actuator includes a frangible portion intermediate the proximal and distal portions that is configured to permit the elongate actuator proximal portion to be separated and removed from the distal portion after fixing the bone anchor relative to the body.

4. The spinal fixation system of claim 3 wherein the elongate actuator and the locking cap have rotary locking structures configured to be engaged and shift the locking cap toward the distal portion of the elongate actuator with turning of the locking cap in a locking direction.

5. The spinal fixation system of claim 3 wherein the body has a through opening sized to receive the elongate actuator therein.

6. The spinal fixation system of claim 5 wherein the locking cap includes a through opening sized to receive the elongate actuator therein which is aligned with the through opening of the body when the locking cap is connected to the elongate actuator.

7. The spinal fixation system of claim 3 wherein the shank portion of the bone anchor extends along a longitudinal axis thereof and the seat of the body is laterally offset from the shank portion longitudinal axis to permit the spinal rod to travel along the elongate actuator proximal portion and be received on the seat laterally offset from the shank portion longitudinal axis.

8. A spinal fixation system for securing a spinal rod relative to a spinal bone, the system comprising:

a bone anchor having a head with a socket and a shank depending from the head, the shank extending along a longitudinal axis;

a coupling device for being connected to the bone anchor;

an elongate guide member of the coupling device having a longitudinal axis;

an outer surface of the elongate guide member for engaging and guiding the spinal rod;

an upwardly open seat of the coupling device laterally offset from the shank longitudinal axis and the elongate guide member outer surface to permit the spinal rod to be slid downward along the outer surface and received on the upwardly open seat laterally offset from the shank longitudinal axis; and

a flexible ball portion of the coupling device that is integral with the upwardly open seat of the coupling device so that the flexible ball portion and the upwardly open seat have a one-piece construction with the flexible ball portion thereof being sized and configured to be received in the socket of the bone anchor head to form a ball and socket joint therewith;

wherein the coupling device includes a one-piece body that includes the seat and the flexible ball portion;

the body and elongate guide member include primary engagement surfaces arranged and configured such that shifting the elongate guide member from an initial position toward a locking position brings the primary engagement surfaces together which deflects the flexible ball portion outwardly against an inner surface of the bone anchor socket; and

wherein the body and the elongate guide member include secondary engagement surfaces adjacent the primary engagement surfaces that are configured such that shifting the elongate guide member to an intermediate position between the initial and locking positions brings the secondary engagement surfaces together and produces an initial outward deflection of the flexible ball portion.

9. A spinal fixation system for securing a spinal rod to a spinal bone, the system comprising:

a bone anchor having a spherical head portion and a shank portion depending from the spherical head portion;

a body having a seat and a cup portion, the seat configured for receiving a spinal rod;

an elongate actuator having a proximal portion for upstanding from the body configured to permit the spinal rod to travel therealong toward the body and a distal portion having a plurality of flexible fingers defining a socket for receiving the spherical bone anchor head, the body being shiftable relative to the elongate actuator including the proximal and distal portions thereof from an initial position where the body cup portion is not fully seated on the flexible fingers which permits relative movement between the bone anchor and the body toward a locking position where the body cup portion is fully seated on the flexible fingers and constricts the flexible fingers about the spherical bone anchor head which fixes the bone anchor relative to the body; and

a locking cap configured to be connected to the elongate actuator to engage the spinal rod and secure the spinal rod on the seat of the body;

wherein the body has a through opening sized to receive the elongate actuator therein; and

wherein the body includes an arm that includes at least a portion of the seat with the arm extending laterally from the body through opening such that the spinal rod is positioned laterally relative to the elongate actuator on the arm.

10. A spinal fixation system for securing a spinal rod relative to a spinal bone, the system comprising:

a bone anchor having a spherical head and a shank depending from the head, the shank extending along a longitudinal axis;

a coupling device for being connected to the bone anchor;

an elongate guide member of the coupling device having a proximal end portion and a distal end portion and a longitudinal axis extending therebetween, the distal end portion including a flexible socket sized for fitting about the spherical head of the bone anchor for forming a ball and socket joint therewith;

an outer surface of the elongate guide member for engaging and guiding the spinal rod;

a body of the coupling device having a through opening sized to receive the proximal end portion of the elongate guide member extending therethrough to permit the body to be advanced along the elongate guide member toward the distal end portion thereof;

an upwardly open seat of the body laterally offset from the shank longitudinal axis and the elongate guide member outer surface to permit the spinal rod to be slid downward along the outer surface and received on the upwardly open seat laterally offset from the shank longitudinal axis;

a cup portion of the body configured to engage and constrict the flexible socket of the elongate guide member about the spherical bone anchor head for fixing the elongate guide member relative to the bone anchor with shifting of the body cup portion distally over the elongate guide member flexible socket; and

wherein the upwardly open seat of the body extends about a seat axis along which the spinal rod is oriented with the spinal rod received on the upwardly open seat and the seat axis is laterally offset from the bone anchor shank longitudinal axis.

11. The spinal fixation system of claim 10 further comprising a locking device having a clamping portion configured to engage the spinal rod and an opening sized to receive the elongate guide member therethrough to allow the locking device to be advanced onto and downward along the elongate guide member to clamp the spinal rod against the body seat.

12. The spinal fixation system of claim 11 wherein the locking device has an inner portion configured to be connected to the elongate guide member and the clamping portion includes an outer clamping member extending laterally from the inner portion to clamp the spinal rod against the body seat.

13. The spinal fixation system of claim 10 wherein the body includes a lateral opening to the seat in communication with the body through opening to minimize the lateral distance between the elongate guide member and the spinal rod with the spinal rod received on the seat.

14. The spinal fixation system of claim 10 wherein the elongate guide member flexible socket and the bone anchor spherical head portion are configured to permit the elongate guide member longitudinal axis and the bone anchor shank longitudinal axis to be coaxially aligned with the flexible socket connected to the spherical head portion.

Assignments (13)
SECURITY INTEREST Recorded Aug 11, 2024
From: XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.; SURGALIGN SPV, INC.; XTANT MEDICAL HOLDINGS, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 068539/0492 →
SECURITY INTEREST Recorded Aug 11, 2024
From: XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.; SURGALIGN SPV, INC.; XTANT MEDICAL HOLDINGS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 068539/0665 →
SECURITY AGREEMENT SUPPLEMENT (TERM) Recorded Dec 22, 2023
From: XTANT MEDICAL HOLDINGS, INC.; XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 066095/0635 →
SECURITY AGREEMENT SUPPLEMENT (REVOLVING) Recorded Dec 22, 2023
From: XTANT MEDICAL HOLDINGS, INC.; XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 066095/0652 →
MERGER Recorded Oct 19, 2023
From: PIONEER SURGICAL TECHNOLOGY, INC.
To: PIONEER SURGICAL TECHNOLOGY NEWCO, INC.
Reel/Frame 065287/0641 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2023
From: PIONEER SURGICAL TECHNOLOGY NEWCO, INC.
To: XTANT MEDICAL HOLDINGS, INC.
Reel/Frame 065218/0590 →
RELEASE OF SECURITY INTEREST Recorded Jul 21, 2020
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: RTI SURGICAL, INC.; PIONEER SURGICAL TECHNOLOGY, INC.; TUTOGEN MEDICAL, INC.
Reel/Frame 053260/0398 →
RELEASE OF SECURITY INTEREST Recorded Jul 20, 2020
From: ARES CAPITAL CORPORATION, AS AGENT
To: RTI SURGICAL, INC.; PIONEER SURGICAL TECHNOLOGY, INC.; TUTOGEN MEDICAL, INC.; PARADIGM SPINE, LLC; FOURTH DIMENSION SPINE, LLC
Reel/Frame 053257/0652 →
SECURITY INTEREST Recorded Mar 8, 2019
From: RTI SURGICAL, INC.; PIONEER SURGICAL TECHNOLOGY, INC.; TUTOGEN MEDICAL, INC.; PARADIGM SPINE, LLC; FOURTH DIMENSION SPINE, LLC
To: ARES CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT
Reel/Frame 048543/0505 →
RELEASE OF SECURITY INTEREST Recorded Jun 7, 2018
From: TD BANK, N.A., AS ADMINISTRATIVE AGENT
To: PIONEER SURGICAL TECHNOLOGY, INC.
Reel/Frame 046320/0040 →
SECURITY INTEREST Recorded Jun 6, 2018
From: RTI SURGICAL, INC.; PIONEER SURGICAL TECHNOLOGY, INC.; TUTOGEN MEDICAL, INC.
To: JPMORGAN CHASE BANK, N.A., AS THE ADMINISTRATIVE AGENT
Reel/Frame 046303/0926 →
SECURITY AGREEMENT Recorded Jul 29, 2013
From: PIONEER SURGICAL TECHNOLOGY, INC.
To: TD BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 030892/0193 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2012
From: JANOWSKI, BRIAN P.
To: PIONEER SURGICAL TECHNOLOGY, INC.
Reel/Frame 027965/0250 →
Continuity (2)
Provisional Application 61442617 · Feb 14, 2011
Related Publication 20120209332A1 · Aug 16, 2012