US9554909B2

US PATENT 9,554,909 B2         ORTHOPEDIC ANCHORING SYSTEM AND METHODS

Systems and methods for performing orthopedic surgical procedures to treat a patient are presented herein. The orthopedic anchoring system may include an implant assembly and a delivery tool to perform the orthopedic surgical procedure. The implant assembly may include an implant outer layer, an implant body situated within the implant outer layer, and a fastener attached to a locking element of the implant body. The delivery tool may include a targeting arm, a fastener guide removably attached at a first end of the targeting arm and an implant guide removably attached to a second end of the targeting arm. The delivery tool may maintain a fixed spatial relationship between a longitudinal axis of the fastener and a longitudinal axis of the implant outer layer and implant body. The orthopedic anchoring system may be used to perform orthopedic surgical procedures related to joint reinforcement or immobilization.

CLAIMS

What is claimed is: 

1. An orthopedic anchoring system comprising:

an implant assembly comprising:

an implant body comprising at least a portion of a locking element comprising a slot having lateral sides formed in the implant body;

an implant outer layer comprising a longitudinal axis and a lumen extending parallel to the longitudinal axis, wherein the lumen is configured to receive at least a portion of the implant body within the lumen; and

a fastener comprising an attachment feature configured to mechanically interlock with the locking element in a force-fit mechanical engagement, the attachment feature comprising a fastener distal end attached to the fastener by a contracted neck region, wherein the fastener distal end is configured to be forced through the slot to produce the force-fit mechanical engagement between the lateral sides of the slot and the fastener distal end;

a 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 a final manufactured configuration of the implant assembly are such that, when the system is assembled such that the implant guide is releasably coupled to 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. 

2. The system of claim 1, wherein in being coupled together, the implant guide and fastener guide form an angle relative to each other, and the angle is non-adjustable. 

3. The system of claim 1, wherein the locking element is situated near a distal end of the implant body. 

4. The system of claim 3, wherein the implant outer layer further comprises a fastener opening configured to provide a path through which the attachment feature passes to engage the locking element in a force-fit mechanical engagement. 

5. The system 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 connect to the second alignment feature, resulting in a predetermined angular alignment of the implant body within the lumen about a rotational axis aligned parallel to the longitudinal axis and situated along a centerline of the implant body. 

6. The system of claim 5, wherein: the first alignment feature comprises a first non-circular cross-sectional profile, the second alignment feature comprises a second non-circular cross-sectional profile corresponding to the first non-circular cross-sectional profile, and the first non-circular cross-sectional profile and the second non-circular cross-sectional profile are aligned only at the predetermined angular alignment. 

7. The system of claim 5, wherein: the first alignment feature is chosen from a longitudinal ridge or groove formed on an outer surface of the implant body and aligned with the longitudinal axis; the second alignment feature is chosen from corresponding longitudinal groove or ridge formed on an inner surface defining the lumen of the implant outer layer and aligned with the longitudinal axis; and the longitudinal ridge or groove meshes with the corresponding longitudinal groove or ridge as the implant body is advanced distally into the lumen only at the predetermined angular alignment. 

8. The system of claim 1, wherein the delivery tool further comprises a targeting arm comprising a first arm end and an opposite second arm end, wherein the first arm end is configured to releasably attach the fastener guide and the second arm end is configured to releasably attach the implant guide to operatively couple the fastener guide and the implant guide. 

9. The system of claim 8, wherein the targeting arm comprises a fixed structural element configured to operatively couple the fastener guide and the implant guide at a non-adjustable angle relative to each other. 

10. The system of claim 1, wherein a pair of longitudinal projections comprises the lateral sides and forms the slot between the pair of longitudinal projections, wherein the fastener distal end is configured to be forced through the slot to produce the force-fit mechanical engagement between the pair of longitudinal projections and the fastener distal end. 

11. The system of claim 1, wherein the fastener distal end comprises a ball end. 

12. The system of claim 1, wherein the fastener distal end comprises a rounded end. 

13. The system of claim 1, wherein the fastener distal end comprises a cone end. 

14. An orthopedic anchoring system comprising:

an implant assembly comprising:

an implant body comprising at least a portion of a locking element comprising a slot formed within the implant body;

an implant outer layer comprising a longitudinal axis and a lumen extending parallel to the longitudinal axis, wherein the lumen is configured to receive at least a portion of the implant body within the lumen; and

a fastener comprising an attachment feature configured to mechanically interlock with the locking element in an interference mechanical engagement, the attachment feature comprises a fastener distal end attached to the fastener by contracted neck region, the locking element extending from a distal end of the implant body in a direction parallel with the longitudinal axis, wherein the slot comprises a slot width between a diameter of the neck region and a diameter of the fastener distal end, the slot is configured to receive the neck region of the attachment feature to retain the fastener distal end and to produce the interference mechanical engagement;

a 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 a final manufactured configuration of the implant assembly are such that, when the system is assembled such that the implant guide is releasably coupled to the implant body, a delivery arrangement automatically exists such that the fastener guide is correctly oriented to deliver the attachment feature to the locking element. 

15. The system of claim 14, wherein the fastener is situated in a final fastener position and the implant body is advanced in a distal direction to form the interference mechanical engagement. 

16. The system of claim 15, wherein the implant outer layer further comprises a second locking element comprising a fastener opening configured to receive the attachment feature and to produce the interference mechanical engagement cooperatively with the locking element of the implant body when the implant body is advanced distally within the lumen of the implant outer layer. 

17. The system of claim 14, 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 connect to the second alignment feature, resulting in a predetermined angular alignment of the implant body within the lumen about a rotational axis aligned parallel to the longitudinal axis and situated along a centerline of the implant body, the first alignment feature comprises a first non-circular cross-sectional profile, the second alignment feature comprises a second non-circular cross-sectional profile corresponding to the first non-circular cross-sectional profile, and the first non-circular cross-sectional profile and the second non-circular cross-sectional profile are aligned only at the predetermined angular alignment. 

18. The system of claim 14, 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 connect to the second alignment feature, resulting in a predetermined angular alignment of the implant body within the lumen about a rotational axis aligned parallel to the longitudinal axis and situated along a centerline of the implant body, the first alignment feature is chosen from a longitudinal ridge or groove formed on an outer surface of the implant body and aligned with the longitudinal axis; the second alignment feature is chosen from corresponding longitudinal groove or ridge formed on an inner surface defining the lumen of the implant outer layer and aligned with the longitudinal axis; and the longitudinal ridge or groove meshes with the corresponding longitudinal groove or ridge as the implant body is advanced distally into the lumen only at the predetermined angular alignment. 

19. The system of claim 5, wherein the attachment feature is configured to mechanically interlock with the locking element in an interference mechanical engagement, and wherein: the first alignment feature is chosen from a pin or pin receptacle formed on an outer surface of the implant body; the second alignment feature is chosen from a corresponding pin receptacle or pin formed on an inner surface defining the lumen of the implant outer layer; and wherein when the implant body is actuated within the lumen the locking element is guided in a predetermined orientation as a result of the first alignment feature being operatively connected to the second alignment feature via a meshing of the pin or pin receptacle with the corresponding pin receptacle or pin. 

20. The system of claim 14, 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. 

21. The system of claim 20, wherein: the implant outer layer comprises a contoured surface at a distal end of the lumen shaped to correspond with a shape of 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. 

22. The system of claim 20, wherein: at least a portion of the attachment feature comprises a spherical shape and the body depression 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 body depression. 

23. The system of claim 21, wherein: at least a portion of the attachment feature comprises a spherical shape and the contoured surface at a distal end of the lumen 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 at a distal end of the lumen. 

24. The system of claim 14, wherein the fastener distal end comprises a ball end. 

25. The system of claim 14, wherein the fastener distal end comprises a rounded end. 

26. The system of claim 14, wherein the fastener distal end comprises a cone end. 

27. An orthopedic anchoring system comprising:

an implant assembly comprising:

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

an implant outer layer comprising a longitudinal axis and a lumen extending parallel to the longitudinal axis, wherein the lumen is configured to receive at least a portion of the implant body within the lumen, the implant outer layer further comprises a first alignment feature formed on the inner surface of the lumen, an exterior surface, a fastener opening, a fastener opening perimeter; and

a fastener comprising an attachment feature configured to mechanically interlock with the locking element in an interference mechanical engagement, the attachment feature comprising a distal end attached to the fastener by a contracted neck region;

a 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 a final manufactured configuration of the implant assembly are such that, when the system is assembled such that the implant guide is releasably coupled to 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, wherein the fastener opening communicates between the exterior surface and the lumen through a lumen wall and is configured to provide a path through which the attachment feature passes to engage the locking element in the interference mechanical engagement;

the implant body further comprises a second alignment feature formed on an exterior surface of the implant body configured to operatively engage with the first alignment feature;

the locking element comprises a slot formed through the implant body at a distal region of the implant body, wherein the slot comprises a first end and a second end opposite the first end, a first slot side and a second slot side opposite the first slot side, each of the first and second slot sides attached to the first end and toward the second slot end, a slot width extending between the first slot side and second slot side near a first slot end and dimensioned to include a width which is between a diameter of the contracted neck region and a diameter of the distal end of the attachment feature of the fastener; and the slot is 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; and

wherein, when the implant assembly transitions from a first or open condition to a second or locked condition, the first alignment feature being operatively connected to the second feature results in a predetermined alignment of both the implant body relative to the implant outer layer and the slot relative to a position of the attachment feature when received within the lumen through the fastener opening such that the slot and the attachment feature mechanically interlock once in the second or locked condition, the first or open condition being when the locking element does not engage the attachment feature and the second or locked condition being when the locking element engages the attachment feature. 

28. The system of claim 27, 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 selectively rotate freely relative to the shaft and further configured to couple with an elongate reinforcing element. 

29. The system of claim 28, wherein: the implant outer layer comprising an exterior surface with a transverse cross sectional profile comprising at least three apices. 

30. The system of claim 28, wherein: the first alignment feature comprises a first non-circular cross-sectional profile, the second alignment feature comprises a second non-circular cross-sectional profile corresponding to the first non-circular cross-sectional profile, and the first non-circular cross-sectional profile and the second non-circular cross-sectional profile are aligned only at the predetermined alignment. 

31. The system of claim 28, wherein: the first alignment feature is chosen from a longitudinal ridge or groove formed on an outer surface of the implant body and aligned with the longitudinal axis; the second alignment feature is chosen from corresponding longitudinal groove or ridge formed on an inner surface defining the lumen of the implant outer layer and aligned with the longitudinal axis; and the longitudinal ridge or groove meshes with the corresponding longitudinal groove or ridge as the implant body is advanced distally into the lumen only at the predetermined alignment. 

32. The system of claim 28, wherein: the first alignment feature is chosen from a pin or pin receptacle formed on an outer surface of the implant body; the second alignment feature is chosen from corresponding pin receptacle or pin formed on an inner surface defining the lumen of the implant outer layer; and wherein when the implant body is actuated within the lumen the locking element is guided in a predetermined orientation as a result of the first alignment feature being operatively connected to the second alignment feature via a meshing of the pin or pin receptacle with the corresponding pin receptacle or pin. 

33. The system of claim 28, 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. 

34. The system of claim 33, wherein: the implant outer layer comprises a contoured surface at a distal end of the lumen shaped to correspond with the 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. 

35. The system of claim 33, wherein: the at least a portion of the attachment feature comprises a spherical shape and the body depression 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 body depression. 

36. The system of claim 34, wherein: the at least a portion of the attachment feature comprises a spherical shape and the contoured surface at the distal end of the lumen 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 at the distal end of the lumen. 

37. The system of claim 28, 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. 

38. The system of claim 28, 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. 

39. The system of claim 38, wherein: the targeting arm comprises a telescoping arrangement via the two or more linked structural elements. 

40. The system of claim 39, wherein: the targeting arm comprises a first section ending in a first arm end and a second section ending in a second arm end; both sections having matched circular arc shapes with a common center. 

41. The system of claim 40, wherein: one of the first or second sections comprises a hollow cross-section having a central lumen, and one of the second or first sections is shaped and dimensioned to fit within the central lumen by sliding along an arc length of one of the first or second sections. 

42. The system of claim 38, 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. 

43. The system of claim 42, wherein: the targeting arm further comprises a locking mechanism selected from at least one of a set screw, a clamp, a peg, a compression fitting, and any combination thereof and configured such that the elongate shape of the targeting arm and the sliding attachment fitting may be locked into a fixed position when employing the locking mechanism. 

44. The system of claim 42, wherein: the two or more linked structural elements comprises a horizontal segment linked to a vertical segment wherein the arrangement between the horizontal segment and vertical segment result in a sliding in a horizontal direction along the horizontal segment to adjust a relative position of the vertical segment. 

45. The system of claim 28, wherein: the targeting arm comprises two or more hinged or jointed subsections resulting in the delivery arrangement. 

46. The system of claim 28, wherein: the targeting arm comprises one or more bendable subsections having limited deformability resulting in the delivery arrangement. 

47. The system of claim 28, wherein: the fastener guide is operably couple 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 allows limited movement of the fastener guide including at least one of rotation of the fastener guide about a fastener longitudinal axis and translation of the fastener guide along the fastener longitudinal axis such that even 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. 

48. The system of claim 47, 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. 

49. The system of claim 28, wherein: 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 head of the fastener. 

50. The system of claim 27, wherein the distal end of the attachment feature comprises a ball end. 

51. The system of claim 27, wherein the distal end of the attachment feature comprises a rounded end. 

52. The system of claim 27. wherein the distal end of the attachment feature comprises a cone end.