US-12616587-B2 - Sacro-iliac joint stabilizing implants and methods of implantation

Abstract

Sacro-iliac joint stabilizing implants adapted for implanting across a SI joint from a dorsal approach. Methods of, and delivery tools adapted for implanting sacro-iliac joint stabilizing implants across a SI joint from a dorsal approach.

Inventors

• Mary E. STUART
• Babajide OGUNSEINDE
• David A. PROVENZANO
• Paul M. Sand
• Bret SCHNEIDER
• W. Carlton RECKLING
• Francois FOLLINI
• Scott A. Yerby
• Vikas V. PATEL
• Jack B. RENTZ
• Richard A. Hynes

Assignees

• SI-BONE INC.

Dates

Publication Date

20260505

Application Date

20240722

Claims (13)

1. 1 . A sacroiliac (SI) joint stabilizing implant for implanting across a SI joint from a dorsal approach, comprising: an implant body having a wafer configuration with a width dimension greater than a height dimension, the implant body including: a central joint portion for placement across the SI joint; an ilium portion on a first side of the central joint portion, the ilium portion sized and configured for implanting into an ilium when the implant is implanted across the SI joint from a dorsal approach, the ilium portion comprising an elongate ilium lumen extending from a distal opening to a proximal opening and having an ilium lumen longitudinal axis, the ilium lumen sized and configured to receive therein an ilium positioning guide; and a sacrum portion on a second side of the central joint portion, the sacrum portion sized and configured for implanting into a sacrum when the implant is implanted across the SI joint from the dorsal approach, and wherein with reference to a reference line that is orthogonal to the ilium lumen longitudinal axis, the ilium portion extends further distally than the sacrum portion and/or the sacrum portion extends further proximally than the ilium portion, wherein a sacrum lumen has a length that is greater than a length of the ilium lumen.
2. 2 . The implant of claim 1 , wherein the ilium lumen is parallel with the sacrum lumen.
3. 3 . The implant of claim 1 , wherein the ilium portion has an ilium length, and the sacrum portion has a sacrum length, wherein the ilium length is greater than the sacrum length.
4. 4 . The implant of claim 1 , wherein the ilium portion has an ilium length, and the sacrum portion has a sacrum length, wherein the ilium length is the same as the sacrum length.
5. 5 . A sacroiliac (SI) joint stabilizing implant for implanting across a SI joint from a dorsal approach, comprising: an implant body having a wafer configuration with a width dimension greater than a height dimension, the implant body including: a central joint portion for placement across the SI joint; an ilium portion on a first side of the central joint portion, the ilium portion sized and configured for implanting into an ilium when the implant is implanted across the SI joint from a dorsal approach, the ilium portion comprising an elongate ilium lumen extending from a distal opening to a proximal opening and having an ilium lumen longitudinal axis, the ilium lumen sized and configured to receive therein an ilium positioning guide; and a sacrum portion on a second side of the central joint portion, the sacrum portion sized and configured for implanting into a sacrum when the implant is implanted across the SI joint from the dorsal approach, and wherein with reference to a reference line that is orthogonal to the ilium lumen longitudinal axis, the ilium portion extends further distally than the sacrum portion and/or the sacrum portion extends further proximally than the ilium portion, wherein the ilium portion has an ilium length, and the sacrum portion has a sacrum length, wherein the sacrum length is greater than the ilium length.
6. 6 . The implant of claim 1 , wherein a sacrum lumen extends further proximally than the ilium lumen.
7. 7 . The implant of claim 1 , wherein the ilium lumen extends further distally than a sacrum lumen.
8. 8 . The implant of claim 1 , wherein at least one of the ilium distal opening and a sacrum lumen distal opening extends further distally than at least a portion of the central portion of the implant body.
9. 9 . The implant of claim 8 , wherein both of the ilium distal opening and the sacrum lumen distal opening extend further distally than the central portion.
10. 10 . The implant of claim 1 , wherein the implant body further comprises an inner frame and an outer porous network of interconnected struts extending about at least a top portion and a bottom portion of the implant.
11. 11 . The implant of claim 1 , wherein with reference to the reference line, the ilium portion extends further distally than the sacrum portion and the sacrum portion extends further proximally than the ilium portion.
12. 12 . A sacroiliac (SI) joint stabilizing implant for implanting across a SI joint from a dorsal approach, comprising: an implant body having a wafer configuration with a width dimension greater than a height dimension, the implant body including; a central joint portion for placement across the SI joint; an ilium portion on a first side of the central joint portion, the ilium portion sized and configured for implanting into an ilium when the implant is implanted across the SI joint from a dorsal approach; and a sacrum portion on a second side of the central joint portion, the sacrum portion sized and configured for implanting into a sacrum when the implant is implanted across the SI joint from the dorsal approach, and wherein with reference to a reference line that is orthogonal to an implant body longitudinal axis, the ilium portion extends further distally than the sacrum portion and/or the sacrum portion extends further proximally than the ilium portion, wherein the ilium portion has an ilium length, and the sacrum portion has a sacrum length, wherein the sacrum length is greater than the ilium length.
13. 13 . The implant of claim 12 , wherein with reference to the reference line, the ilium portion extends further distally than the sacrum portion and the sacrum portion extends further proximally than the ilium portion.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 18/356,880, filed Jul. 21, 2023, which is a continuation of U.S. application Ser. No. 17/812,945, filed Jul. 15, 2022, now U.S. Pat. No. 11,752,011, which is a continuation of International Application No. PCT/US2021/062337, filed Dec. 8, 2021, which claims the benefit of priority of U.S. Provisional Application No. 63/123,404, filed Dec. 9, 2020, and U.S. Provisional Application No. 63/202,390 filed Jun. 9, 2021, the disclosures of which are incorporated by reference herein in their entirety for all purposes. INCORPORATION BY REFERENCE This application incorporates by reference in its entirety for all purposes the entire disclosure of PCT publication WO2021/119126A1. All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND Implants may be positioned across a sacro-iliac (“SI”) joint to help stabilize the joint. Portions of the ilium may have greater density than portions of the sacrum into which the implant is implanted. Depending on one or more of the delivery trajectories, the target location for implantation, and the configuration of the implant, the differences in bone density may present challenges while advancing some SI joint implants across the SI joint. Implants and methods of delivery are needed that accommodate for the differences in bone density and can facilitate the successful delivery of the SI joint implant from a dorsal approach across the SI joint. Additionally, implants are needed that are configured and sized to be safely implanted into a target anatomical region. SUMMARY OF THE DISCLOSURE This disclosure describes implants that are sized and configured to be implanted across an SI Joint from a dorsal trajectory to stabilize the joint. This disclosure also describes delivery tools that are adapted to deliver and position implants across an SI Joint from a dorsal trajectory. This disclosure also describes methods of implanting implants across an SI Joint from a dorsal trajectory. One aspect of the disclosure is a sacro-iliac joint stabilizing implant for implanting across a SI joint from a dorsal approach, the implant having an implant body. The implant body has a central joint portion for placement across the SI joint, an ilium portion on a first lateral side of the central joint portion, the ilium portion sized and configured for implanting into an ilium when the implant is implanted across a SI joint from a dorsal approach, and a sacrum portion on a second lateral side of the central joint portion, the sacrum portion sized and configured for implanting into a sacrum when the implant is implanted across the SI joint from the dorsal approach. In this aspect, the implant body may have a wafer configuration with a width dimension greater than a height dimension. In this aspect, the ilium portion may comprise and define an elongate ilium lumen that extends from a distal opening to a proximal opening and has an ilium lumen longitudinal axis, the ilium lumen sized and configured to receive therein an ilium positioning guide. In this aspect, and with reference to a line that is orthogonal to an ilium lumen axis, the sacrum portion may extend further proximally than the ilium portion. In this aspect, the implant body may include a distal portion that includes a sharpened distal end extending at least in the central joint portion, the sharpened distal end having a tapered configuration with a first surface that tapers downward and distally from a top portion of the implant body and a second surface that tapers upward and distally from a bottom portion of the implant body. In this aspect, the implant body may have a proximal end having at least one surface feature configured to interface with a delivery tool (e.g., an impactor) to facilitate delivery of the implant body in a direction of implantation, and with reference to a line orthogonal to the direction of implantation, the sacrum portion may extend further proximally than the ilium portion. In this aspect, a sharpened distal end of the implant body may have, in a top view, a concave curved configuration along at least a portion of the sharpened distal end. A curved configuration may be asymmetrical about a long axis of the implant body. A sharpened distal end may extend further distally in the ilium portion than in the sacrum portion. In this aspect, a sharpened distal end of the implant body may extend laterally through the sacrum portion, the central portion, and the ilium portion. In this aspect, a sharpened distal end may comprise a smooth curve. In this aspect, a portion of the ilium portion may extend further distally than a sharpened distal end. In this aspect, a portion of the sacrum portion may extend further distally