US10335197

US PATENT 10,335,197 B2

ORTHOPEDIC ANCHORING METHODS

Methods for performing orthopedic surgical procedures to treat a patient are presented herein. A method may include: positioning an implant assembly at the pelvic region, the implant assembly including an implant body including at least a portion of a locking element, an implant outer layer, and a fastener including a longitudinal axis and an attachment feature configured to mechanically interlock with the locking element in an interference mechanical engagement, the attachment feature comprising a distal end and a contracted neck region; delivering the implant outer layer into the ilium, across the sacroiliac joint, and into the sacrum such that a fastener opening of the implant outer lay resides within the sacrum; delivering the fastener through a posterior surface of the sacrum such that the distal end of the attachment feature is received within the implant outer layer; and interlocking the locking element and the attachment feature with each other.

CLAIMS

What is claimed is:

1. A method of performing an orthopedic surgical procedure on a pelvic region of a patient, the pelvic region including a sacrum, an ilium and a sacroiliac joint therebetween, the method comprising:

positioning an implant assembly adjacent the pelvic region, the implant assembly comprising:

i) an implant body comprising at least a portion of a locking element;

ii) an implant outer layer comprising a longitudinal axis, a lumen extending parallel to the longitudinal axis, an exterior surface, and a fastener opening including a fastener opening perimeter, and a fastener path, wherein the lumen is configured to receive at least a portion of the implant body within the lumen;

iii) a fastener comprising a longitudinal axis and an attachment feature configured to mechanically interlock with the locking element in an interference mechanical engagement, the attachment feature comprising a distal end and a contracted neck region, wherein the attachment feature is configured to mechanically interlock with the locking element when the distal end of the attachment feature is received within the fastener opening of the implant outer layer, and when there is a predetermined alignment between the implant body relative to the implant outer layer and the locking element relative to the attachment feature, respectively,

delivering the implant body and the implant outer layer into the ilium, across the sacroiliac joint, and into the sacrum such that the fastener opening resides within the sacrum;

delivering the fastener through a posterior surface of the sacrum such that the distal end of the attachment feature is received within the implant outer layer; and interlocking the locking element and the attachment feature with each other.

2. The method of claim 1, wherein the implant outer layer further comprises a first alignment feature and the implant body further comprises an second alignment feature, wherein the first alignment feature is configured to operatively engage with the second alignment feature resulting in a first portion of the predetermined alignment of the implant body within the lumen of the implant outer layer.

3. The method of claim 1, wherein the exterior surface of the implant outer layer comprises a generally elongate triangular box.

4. The method of claim 1, wherein the locking element comprises a distal region and a slot formed through the implant body at the distal region, wherein the slot comprises a first end, a second end opposite the first end, a first slot side, a second slot side opposite the first slot side, and a slot width, the first and second slot sides attached to the first end and extending generally parallel to one another away from the first slot end and towards the second slot end, the slot width extending between the first slot side and second slot side and being between a diameter of the contracted neck region and a diameter of the distal end of the attachment feature of the fastener, the slot configured to receive the contracted neck region of the attachment feature to retain the distal end of the attachment feature and to produce the interference mechanical engagement.

5. The method of claim 1 further comprising: orienting the fastener opening toward the posterior surface of the sacrum such that the fastener path permits the fastener to extend generally posterior to anterior; and orienting the fastener with the implant outer layer such that the fastener longitudinal axis is aligned with the fastener path.

6. The method of claim 1, wherein the distal end of the attachment feature comprises a ball end.

7. The method of claim 1, wherein the distal end of the attachment feature comprises a rounded end.

8. The method of claim 1, wherein the distal end of the attachment feature comprises a cone end.

9. The method of claim 1, wherein: the fastener further comprises a proximal end, a distal end opposite the proximal end, a threaded shaft extending between the proximal and distal ends, and a head coupled to the proximal end and configured to rotate freely relative to the shaft and further configured to couple with an elongate reinforcing element.

10. The method of claim 9, comprising: coupling the elongate reinforcing element with the head of the fastener.

11. The method of claim 9, wherein: the implant body further comprises a distal region comprising a body depression contoured to a shape of at least a portion of the attachment feature; and wherein, when the body depression is compressed against the attachment feature, a meshing engagement therebetween comprises the interference mechanical engagement.

12. The method of claim 11, wherein: the at least a portion of the attachment feature comprises at least a portion of a spherical shape and the body depression comprises a contour which is a general surface negative of the at least a portion of the spherical shape; and wherein the at least a portion of the spherical shape of the at least a portion of the attachment feature is configured and dimensioned to fit at least partially within the body depression.

13. The method of claim 9, wherein: the implant outer layer comprises a contoured surface shaped to correspond with a shape of the at least a portion of the attachment feature to enhance a locked engagement formed between the attachment feature of the fastener and the locking element of the implant body.

14. The method of claim 13, wherein: the at least a portion of the attachment feature comprises a spherical shape and the contoured surface of the implant outer layer comprises a contour which is a general surface negative of the spherical shape; and wherein the spherical shape of the at least a portion of the attachment feature is configured and dimensioned to fit closely within the contoured surface of the implant outer layer.

15. The method of claim 1, further comprising: positioning a delivery tool at the pelvic region, the delivery tool comprising: an implant guide configured to releasably couple to at least one of the implant body or the implant outer layer; and a fastener guide operably coupled to the implant guide and configured to deliver the attachment feature of the fastener to the locking element; wherein a final manufactured configuration of the delivery tool and the implant assembly are such that, when the system is assembled such that the implant guide is releasably coupled to the at least one of the implant body or the implant outer layer, a delivery arrangement automatically exists such that the fastener guide is correctly oriented to deliver the attachment feature to the locking element.

16. The method of claim 15, wherein: the fastener guide is operably coupled to the implant guide via a targeting arm comprising a single continuous structural element having a fixed elongate shape.

17. The method of claim 15, wherein: the fastener guide is operably coupled to the implant guide via a targeting arm comprising two or more linked structural elements having an adjustable elongate shape.

18. The method of claim 17, wherein: the targeting arm comprises a telescoping arrangement via the two or more linked structural elements.

19. The method of claim 18, wherein: the targeting arm comprises a first section ending in a first arm end and a second section ending in a second arm end, the first and second sections including matching circular arc shapes with a common center.

20. The method of claim 17, wherein: the targeting arm further comprises a sliding attachment fitting which permits sliding between the two or more linked structural elements to adjust a relative position thereof.

21. The method of claim 20, wherein: the targeting arm comprises a first section ending in a first arm end and a second section ending in a second arm end, the first and second sections including matching circular arc shapes with a common center.

22. The method of claim 15, wherein: the targeting arm comprises two or more hinged or jointed subsections resulting in the delivery arrangement.

23. The method of claim 15, wherein: the targeting arm comprises one or more bendable subsections having limited deformability resulting in the delivery arrangement.

24. The method of claim 15, wherein: the fastener guide is operably coupled to the implant guide via a targeting arm, the targeting arm attached to the fastener guide at a fastener guide attachment fitting, the fastener guide attachment fitting configured to receive a portion of the fastener guide in a reversibly locked mechanical engagement; wherein, when unlocked, the fastener guide attachment fitting permits limited movement of the fastener guide including at least one of rotation of the fastener guide about the fastener longitudinal axis and translation of the fastener guide along the fastener longitudinal axis such that, when unlocked, the fastener guide attachment fitting is configured to maintain a fixed orientation between the fastener longitudinal axis and the longitudinal axis of the implant outer layer.

25. The method of claim 24, wherein: the fastener guide attachment fitting comprises a collar having a locking mechanism configured to compresses a fastener guide shaft, thereby locking the fastener guide shaft in a reversibly locked mechanical engagement, the locking mechanism selected from one or more set screws, cotter pins, pegs, clamps, bands, compression fittings, and any combination thereof.

26. The method of claim 15, wherein: the fastener further comprises a proximal end, a distal end opposite the proximal end, a threaded shaft extending between the proximal and distal ends, and a head coupled to the proximal end configured to rotate freely relative to the shaft and further configured to couple with an elongate reinforcing element; and, the fastener guide includes a bone screw inserter nested within a sleeve comprising a threaded distal end, a distal end of the bone screw inserter configured to protrude from the threaded distal end of the sleeve, the distal end of the bone screw inserter comprising a screwdriver tip, a screw head fitting positioned proximal the screwdriver tip and wherein the threaded distal end of the sleeve and the screw head fitting of the bone screw inserter are configured to cooperatively reversibly attach to the head of the fastener in a mechanically locked engagement during a formation of the implant assembly and wherein the screwdriver tip is configured to be received within a corresponding screwdriver fitting formed within a portion of the fastener at the proximal end, the screw head fitting configured to be received within an upward-opening groove formed within support elements of the fastener head of the fastener.

27. The method of claim 1, wherein the implant body is at least partially within the lumen of the implant outer layer upon delivery of the implant body and the implant outer layer into the ilium, across the sacroiliac joint, and into the sacrum.

28. A method of performing an orthopedic surgical procedure on a pelvic region of a patient, the pelvic region including a sacrum, an ilium and a sacroiliac joint therebetween, the method comprising:

positioning an implant assembly adjacent the pelvic region, the implant assembly comprising:

i) an implant body comprising at least a portion of a locking element;

ii) an implant outer layer comprising a longitudinal axis, a lumen extending parallel to the longitudinal axis, an exterior surface, and a fastener opening including a fastener opening perimeter, and a fastener path, wherein the lumen is configured to receive at least a portion of the implant body within the lumen;

iii) a fastener comprising a longitudinal axis and an attachment feature configured to mechanically interlock with the locking element in an interference mechanical engagement, the attachment feature comprising a distal end and a contracted neck region, wherein the attachment feature is configured to mechanically interlock with the locking element when the distal end of the attachment feature is received within the fastener opening of the implant outer layer, and when there is a predetermined alignment between the implant body relative to the implant outer layer and the locking element relative to the attachment feature, respectively,

delivering the implant outer layer into the ilium, across the sacroiliac joint, and into the sacrum such that the fastener opening resides within the sacrum;

delivering the implant body into engagement with the implant outer layer; delivering the fastener through a posterior surface of the sacrum such that the distal end of the attachment feature is received within the implant outer layer; and interlocking the locking element and the attachment feature with each other.

29. The method of claim 28, wherein delivering the implant body into engagement with the implant outer layer comprises inserting the implant body at least partially within the lumen of the implant outer layer.