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SI-TECHNOLOGY

Surgeon Inspired. Superior Innovation.

US10433880B2

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US PATENT 10,433,880 B2

SYSTEMS AND METHODS FOR FUSING A SACROILIAC JOINT AND ANCHORING AN ORTHOPEDIC APPLIANCE

An orthopedic anchoring system for attaching a spinal stabilization system and concomitantly fusing a sacroiliac joint is disclosed that includes a delivery tool and an implant assembly for insertion into a joint space of a sacroiliac joint. The implant assembly may be secured using anchors inserted through bores within the implant body and into the underlying sacrum and/or ilium. The implant body may also include an attachment fitting reversibly attached to a guide to provide attachment fittings for elements of the spinal stabilization system. The implant assembly may be releasably coupled to an implant arm of the delivery tool such that the implant arm is substantially aligned with the insertion element of the implant assembly. An anchor arm used to insert the anchor may be coupled to the implant arm in a fixed and nonadjustable arrangement such that the anchor is generally aligned with a bore within the implant assembly.

US10433880B2cover.jpg

CLAIMS

What is claimed is:

1. A method of fusing a sacroiliac joint and providing an anchor for a spinal support system, the method comprising:

a) providing a sacroiliac joint fusion and anchoring system comprising: i) an implant assembly comprising: 1) an implant body comprising; an insertion element comprising: an insertion plate with a proximal insertion element end, a distal insertion element end, a medial face on a medial side of the insertion element, a lateral face on a lateral side of the insertion element and opposite the medial face, and a first bore extending through the medial and lateral faces of the insertion plate, the first bore extending to the distal insertion element end to define an open distal end; and one or more elongate fins, wherein each of the one or more elongate fins projects substantially perpendicularly outward from the medial face or the lateral face of the insertion plate and extends longitudinally between the proximal insertion element end and the distal insertion element end; and an attachment element mechanically attached or attachable to the proximal insertion element end; wherein the attachment element comprises: a) an anchor fitting formed within the attachment element or mechanically attached to the attachment element; and b) an attachment fitting formed within the attachment element or mechanically attached to the attachment element, the attachment fitting configured to attach to a support element of a spinal support system, the attachment fitting not being a bore extending through the attachment element; and 2) an anchor; and ii) a delivery tool comprising: 1) an implant arm comprising a distal implant arm end releasably coupled to the proximal insertion element end of the implant body;

b) preparing an implant receiving space, wherein the implant receiving space extends from a posterior portion of the sacroiliac joint toward an anterior portion of the sacroiliac joint;

c) situating the insertion element of the implant body non-transversely within the implant receiving space and situating the attachment element on a dorsal aspect of the sacrum such that: i) the attachment element is positioned medial to a joint line of the sacroiliac joint; ii) the anchor fitting is situated over a region of the sacrum; and iii) the attachment fitting is positioned medial to and not longitudinally in line with the insertion element.

2. The method of claim 1, further comprising inserting one or more additional fasteners through additional bores formed within the attachment member or insertion member, the one or more additional fasteners chosen from one or more of: a) a first additional fastener inserted through the ilium in a lateral to medial direction such that a distal tip of the first additional fastener is situated within a blind bore formed within a lateral face of the insertion element; b) a second additional fastener inserted through the ilium in a lateral to medial direction such that a distal tip of the second additional fastener is driven through an open bore formed transversely through the insertion element and into the sacrum adjacent to a medial face of the insertion element; c) a third additional fastener inserted through the sacrum in a medial to lateral direction such that a distal tip of the third additional fastener is situated within a blind bore formed within a medial face of the insertion element; d) a fourth additional fastener inserted through the sacrum in a medial to lateral direction such that a distal tip of the fourth additional fastener is situated within the open bore formed transversely through the insertion element and into the ilium adjacent to a medial face of the insertion element; e) a fifth additional fastener inserted through an additional open bore formed through the attachment element in a fifth fastener direction chosen from any one of: a lateral to medial direction into the sacrum, a medial to lateral direction into the sacrum, a medial to lateral direction into the sacrum and ilium, a cranial direction into the sacrum, and a caudal direction into the sacrum.

3. The method of claim 1, further comprising attaching the support element of the spinal support system to the attachment fitting.

4. The method of claim 1, wherein the attachment element and the insertion element are angled relative to each other at a non-orthogonal angle.

5. The method of claim 1, wherein an obtuse angle is defined between the medial face of the insertion element and a distal face of the attachment element.

6. The method of claim 1, wherein the attachment element is mechanically attached to the insertion element prior to situating the insertion element of the implant body non-transversely within the implant receiving space.

7. The method of claim 1, further comprising mechanically attaching the attachment element to the insertion element subsequent to situating the insertion element of the implant body non-transversely within the implant receiving space.

8. The method of claim 1, wherein the support element of the spinal support system comprises a rod.

9. The method of claim 1, wherein the delivery tool further comprises 2) an anchor arm comprising a proximal anchor arm end coupled to the implant arm and a distal anchor arm end opposite to the proximal anchor arm end, wherein the distal anchor arm end distally ends in a sleeve configured to guide the anchor within a predetermined range of anchor insertion trajectories.

10. The method of claim 1, wherein the implant receiving space is prepared via an extra-articular recess access region of the sacroiliac joint.

11. The method of claim 1, further comprising step d) operating a driving tool to insert the anchor on a S2AI trajectory, wherein the distal end of the anchor passes through the anchor fitting, enters the sacrum near a S1 foramen in a medial to lateral direction and further enters the ilium.

12. The method of claim 1, wherein during step c) the anchor fitting is situated over a region of the sacrum near a S1 foramen.

13. The method of claim 1, wherein the attachment fitting comprises a post extending outward from a proximal surface of the attachment element.

14. The method of claim 13, wherein the post comprises a bulbous end portion.

15. The method of claim 14, wherein the attachment fitting further comprises a head and a compression nut, and wherein the bulbous end portion of the post is configured to operably couple with the head and the compression nut in order to secure the support element of the spinal support system.

16. The method of claim 13, wherein the post comprises a cylindrical end portion.

17. The method of claim 16, wherein the attachment fitting further comprises a hook fitting including a post bore and a curved underside, and wherein the cylindrical end portion of the post is configured to slidably engage the post bore of the hook fitting, the curved underside configured to contact the support element of the spinal support system.

18. The method of claim 16, wherein the cylindrical end portion of the post is threaded and the attachment fitting further comprising a pivoting clamp configured to operably couple to the post.

19. The method of claim 1, wherein the attachment fitting further comprises a longitudinal sliding clamp including an elongated channel for receiving a threaded end of a receiving bolt therein, the bolt comprising a through bore for receiving the support element of the spinal support system.

20. A method of fusing a sacroiliac joint and providing an anchor for a spinal support system, the method comprising:

a) providing a sacroiliac joint fusion and anchoring system comprising: i) an implant assembly comprising: 1) an implant body comprising; an insertion element comprising: an insertion plate with a proximal insertion element end, a distal insertion element end, a medial face on a medial side of the insertion element, a lateral face on a lateral side of the insertion element and opposite the medial face, and a first bore extending through the medial and lateral faces of the insertion plate, the first bore extending to the distal insertion element end to define an open distal end; and one or more elongate fins, wherein each of the one or more elongate fins projects substantially perpendicularly outward from the medial face or the lateral face of the insertion plate and extends longitudinally between the proximal insertion element end and the distal insertion element end; and an attachment element mechanically attached or attachable to the proximal insertion element end; wherein the attachment element comprises: a) an anchor fitting formed within the attachment element or mechanically attached to the attachment element; and b) an attachment fitting formed within the attachment element or mechanically attached to the attachment element, the attachment fitting configured to attach to a support element of a spinal support system, the attachment fitting not being a bore extending through the attachment element; and 2) an anchor; and ii) a delivery tool comprising: 1) an implant arm comprising a distal implant arm end releasably coupled to the proximal insertion element end of the implant body;

b) preparing an implant receiving space, wherein the implant receiving space extends from a posterior portion of the sacroiliac joint toward an anterior portion of the sacroiliac joint;

c) situating the insertion element of the implant body non-transversely within the implant receiving space and situating the attachment element on a dorsal aspect of the sacrum such that: i) the attachment element is positioned medial to a joint line of the sacroiliac joint; ii) the anchor fitting is situated over a region of the sacrum; and iii) the attachment fitting is positioned medial to and not longitudinally in line with the insertion element; and

d) inserting a distal end of the anchor through the anchor fitting and through the sacrum in a medial to lateral direction such that the distal end of the anchor is positioned within the first bore of the insertion element.

21. A method of fusing a sacroiliac joint and providing an anchor for a spinal support system, the method comprising:

a) providing a sacroiliac joint fusion and anchoring system comprising: i) an implant assembly comprising: 1) an implant body comprising; an insertion element comprising: an insertion plate with a proximal insertion element end, a distal insertion element end, a medial face on a medial side of the insertion element, a lateral face on a lateral side of the insertion element and opposite the medial face, and a first bore extending through the medial and lateral faces of the insertion plate, the first bore extending to the distal insertion element end to define an open distal end; and one or more elongate fins, wherein each of the one or more elongate fins projects substantially perpendicularly outward from the medial face or the lateral face of the insertion plate and extends longitudinally between the proximal insertion element end and the distal insertion element end; and an attachment element mechanically attached or attachable to the proximal insertion element end the attachment element projecting outward from the medial side of the insertion element while not projecting outward from the lateral side of the insertion element; wherein the attachment element comprises: a) an anchor fitting formed within the attachment element or mechanically attached to the attachment element; and b) an attachment fitting formed within the attachment element or mechanically attached to the attachment element, the attachment fitting configured to attach to a support element of a spinal support system, the attachment fitting not being a bore extending through the attachment element; and 2) an anchor; and ii) a delivery tool comprising: 1) an implant arm comprising a distal implant arm end releasably coupled to the proximal insertion element end of the implant body;

b) preparing an implant receiving space, wherein the implant receiving space extends from a posterior portion of the sacroiliac joint toward an anterior portion of the sacroiliac joint;

c) situating the insertion element of the implant body non-transversely within the implant receiving space and situating the attachment element on a dorsal aspect of the sacrum such that: i) the attachment element is positioned medial to a joint line of the sacroiliac joint; ii) the anchor fitting is situated over a region of the sacrum; and iii) the attachment fitting is positioned medial to and not longitudinally in line with the insertion element.

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    • SG182463
    • TWI599348
  • Materials/

SI-TECHNOLOGY

SI-TECHNOLOGY, LLC is an orthopedic medical device company currently developing new techniques and implants as part of the patented SI-TECHNOLOGY™ SI-DESIS™ Sacroiliac Joint Implant System to help assist physicians address the need for treatment, fixation and proper fusion of painful and dysfunctional sacroiliac joints (SIJ). Those suffering from SIJ pain represent a large group of patients, perhaps 10%-30% of those with low back pain, and until recently sacroiliac joint disease was a condition physicians frequently overlooked or even misdiagnosed.

U.S. Patent Nos. 8,808,377 8,979,928 9,017,407 9,333,090 9,381,045 9,421,109 9,510,872 9,554,909 9,603,638 9,700,356 9,717,539 9,757,154 9,788,961 9,795,396 9,795,419 9,801,546 9,820,783 9,826,986 9,833,265 9,833,320 9,931,212 9,949,835 10,034,676 10,058,430 10,064,727 10,064,728 10,130,477 10,136,995 10,154,861 10,159,573 10,245,087 10,265,176 10,292,720 10,314,710 10,335,197 10,383,664 10,433,880 10,441,318 10,492,688 10,492,802 10,492,915 10,517,734 10,548,643 10,596,003 10,596,004 10,603,055 10,646,236 10,646,258 11,129,718 11,172,939 11,213,325 11,284,798 11,376,026 11,877,931 11,950,813 11,998,222 12,150,733 and 12,318,298; EP Patent Nos. 2523633 (FR, DE, IE, NL, ES, CH, and GB) 2720628 (FR, DE and GB) 2758002 (FR, DE and GB) and 2967651 (FR, DE and GB); AU Patent Nos. 2011205597 2012312658 2014204494 2016204937 2017254857 and 2019216659; CA Patent Nos. 2787152 2849095 and 3002234; CN Patent Nos. 102361601 and 105287056; HK Patent Nos. 1165984 and 1219646; IL Patent Nos. 220892 231588 and 243911; JP Patent Nos. 5710646 5956630 and 6131371; KR 101754138; MX Patent No. 327506; SG Patent No. 182463; TW Patent No. I599348; pending U.S. and foreign patent applications. The SI Logo, SI-TECHNOLOGY, SI-Dx, PELFIX, SI-MOTION, SI-DESIS, SI-DESIS X and their respective icons are trademarks of JCBD, LLC and are used by permission.©2025 SI-TECHNOLOGY, LLC. All rights reserved.