Anchor devices and methods of use

• US 9,980,715 B2
• Filed: 02/05/2015
• Issued: 05/29/2018
• Est. Priority Date: 02/05/2014
• Status: Active Grant

• Current Assignee: Trinity Orthopedics, LLC
• Original Assignee: Trinity Orthopedics, LLC
• Inventors: Marino, James F., Elbanna, Jamil
• Primary Examiner(s): Dang, Son
• Application Number:
  US14/615,278
• Publication Number:
  US 20150216523A1
• Time in Patent Office: 1,209 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0403 Dowels other bone dowels A61B17/68; dowels for connecting prosthetic parts A61F2002/30433
• CPC Class Codes: A61B 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0864 Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Abstract

An anchor device for attaching materials within bone including a body having a distal end region, a proximal end region, and a plurality of struts extending between the distal end region to the proximal end region and at least partially surrounding an interior volume of the body. The anchor device includes an attachment feature positioned within the interior volume of the body and coupled near the distal end region. The attachment feature is configured to secure material to the body. Upon removal of a constraint and after delivery of the anchor device into bone, the body passively transitions from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened.

Claims

1. An anchor device for attaching materials within bone, the anchor device comprising:

a body having a distal end region, a proximal end region, and a plurality of struts extending between the distal end region to the proximal end region and at least partially surrounding an interior volume of the body; and

an attachment feature positioned within the interior volume of the body and coupled near the distal end region, the attachment feature comprising a cleat element configured to secure material to the body, the cleat element comprising at least two suture anchor elements, each suture anchor element having an inner post and an aperture configured to allow material to extend through; and

wherein upon removal of a constraint and after delivery of the anchor device into bone the body passively transitions from a constrained, delivery configuration that is radially contracted and axially elongated to a relaxed, deployment configuration that is radially expanded and axially shortened, and

wherein applying tension to the material extending through the apertures of the at least two suture anchor elements forces the at least two suture anchor elements to pivot laterally outward relative to one another to a splayed configuration.

2. The anchor device of claim 1, wherein the material secured by the attachment feature to the anchor device is suture or cable material.

3. The anchor device of claim 1, wherein the material is further configured to be affixed to a soft tissue structure that is selected from the group consisting of tendon, ligament, and joint capsule.

4. The anchor device of claim 1, wherein the tension applied to the material is maintained by the at least two suture anchor elements wherein at least a part of the material passed through the apertures of the at least two suture anchor elements and wrapped around a common post formed by the inner posts of the at least two suture anchor elements resulting in a portion of the material overlapping another portion of the material.

5. The anchor device of claim 1, further comprising a penetrating tip coupled to the distal end region of the body.

6. The anchor device of claim 5, wherein the penetrating tip has a trephine, fluted or conically-tapered outer geometry to facilitate penetration of bone.

7. The anchor device of claim 1, wherein tensioning of the material approximates the distal end region and the proximal end region causing the plurality of struts to radially expand.

8. The anchor device of claim 1, wherein the proximal end region comprises a discontinuous outer wall defining a proximal opening to the interior volume of the body within which the material is disposed such that soft tissue affixed to the material is in direct contact with the bone.

9. The anchor device of claim 1, wherein the plurality of struts expand near the proximal end region to a greater degree than the plurality of struts expand near the distal end region.

10. The anchor device of claim 1, wherein the body is fabricated from a superelastic metal or polymer.

11. The anchor device of claim 1, wherein the constraint comprises a generally rigid tubular element.

12. The anchor device of claim 11, wherein the generally rigid tubular element comprises a slot to accommodate the material.

13. The anchor device of claim 11, wherein the constraint comprises a circumferential ring element.

14. The anchor device of claim 1, wherein the constraint includes a primary constraint and further comprises a secondary constraint, wherein the secondary constraint is positioned over at least a region of the primary constraint during storage of the anchor device.

15. A suture or soft tissue anchor device configured to employ a self-expanding device that is constrained prior to delivery, in a relatively reduced diameter and relatively extended length, with subsequent deployment and delivery within bone, where it expands to a relatively larger diameter with a relatively shortened length;

in which suture material or cable attached to the soft tissue being approximated or secured to the bone anchor is affixed or otherwise associated with a distal terminus or an element associated with the distal terminus of the anchor, such that tension applied on the suture or cable results in a force that foreshortens the length and expands the diameter of the anchor, the device additionally comprising an attachment feature comprising a cleat element comprising at least two suture anchor elements, each suture anchor element having an inner post and an aperture configured to allow the suture material or cable extend through,

wherein applying tension to the suture material or cable extending through the apertures of the at least two suture anchor elements forces the at least two suture anchor elements to pivot laterally outward relative to one another to a splayed configuration.

16. The device of claim 15, wherein the device is fabricated from a superelastic metal or polymer.

17. The device of claim 15, further comprising a distal tip that is conically tapered to facilitate penetration of bone.

18. The device of claim 17, wherein the distal tip is configured with trephine or fluted geometry to facilitate penetration of bone.

19. The device of claim 18, wherein sutures affixed to a soft tissue structure are passed through an aperture located distally within the device and delivered through a proximal aperture of the device for subsequent tensioning.

20. The device of claim 15, wherein a generally tubular configured primary confinement element is used to maintain the self-expanding device in its confined geometry prior to distal delivery out of the primary confinement element and into the bone.

21. The device of claim 20, wherein the primary confinement element has a slot to accommodate introduction of suture material attached to a soft tissue structure.

22. The device of claim 15, wherein a primary confinement element positioned over the self-expanding device during storage is removed after chilling the self-expanding device immediately or shortly prior to deployment within the bone.

23. The device of claim 22 wherein a secondary confinement element is positioned over the primary confinement element during ambient temperature storage and subsequently removed after chilling the self-expanding device immediately or shortly prior to deployment within the bone.

24. The device of claim 15, wherein the suture material or cable is passed through the apertures of the at least two suture anchor elements and wrapped around a common post formed by the inner posts of the at least two suture anchor elements.