US-12616464-B2 - Stabilization devices

Abstract

Stabilization device embodiments for use in orthopedic procedures to couple to target areas of tissue. Stabilization devices described can be used to fuse, fix, provide a preselected spacing, and/or provide a preselected compression to target areas during use. Stabilization devices can be coupled to target areas using alignment elements such as pins, k-wires, and/or screws.

Inventors

• George Matthew AWTREY
• Robert Michael CARLO, III

Assignees

• WRIGHT MEDICAL TECHNOLOGY, INC.

Dates

Publication Date

20260505

Application Date

20221024

Claims (18)

1. 1 . A stabilization device comprising: a first cannulated leg defining a circular cross section and including a first longitudinal slot extending along an outer wall of the leg; a second cannulated leg substantially parallel to the first leg and defining a circular cross section and including a second longitudinal slot extending along an outer wall of the leg; and a cross-member coupling the first leg to the second leg; wherein the cross-member couples to the first and second legs at a predetermined distance from both ends of each of the first and second legs.
2. 2 . The stabilization device of claim 1 wherein each of the first and second legs comprise an opening along longitudinal axes of the first and second legs.
3. 3 . The stabilization device of claim 2 wherein each of the openings is structured to engage an alignment element.
4. 4 . The stabilization device of claim 2 wherein each of the openings is structured to engage a pin.
5. 5 . The stabilization device of claim 1 wherein the first and second legs and the cross-member are formed from a metal alloy.
6. 6 . The stabilization device of claim 1 wherein the first and second legs and the cross-member are formed from Nitinol.
7. 7 . A stabilization device comprising: a first cannulated leg defining a first longitudinal slot arranged in a wall of the leg; a second cannulated leg substantially parallel to the first leg and defining a second longitudinal slot arranged in a wall of the leg; and a V-shaped cross-member including two linear segments that meet at a vertex and coupling the first leg to the second leg; wherein at least one end of each of the first and second legs extend beyond an outermost edge of the cross-member along a longitudinal axis of the stabilization device.
8. 8 . The stabilization device of claim 7 wherein the at least one end of each of the first and second legs extends beyond an outermost edge of the cross-member such that a plane that includes a first end of the first leg and a first end of the second leg does not contact any portion of the cross-member.
9. 9 . The stabilization device of claim 7 wherein the first and second legs and the cross-member are formed from a metal alloy.
10. 10 . The stabilization device of claim 7 wherein the first and second legs and the cross-member are formed from Nitinol.
11. 11 . The stabilization device of claim 7 wherein each of the first and second legs comprise an opening along longitudinal axes of the first and second legs.
12. 12 . The stabilization device of claim 11 wherein each of the openings is structured to engage an alignment element.
13. 13 . The stabilization device of claim 11 wherein each of the openings is structured to engage a pin.
14. 14 . A stabilization device system comprising: a first alignment element; a second alignment element; a cut guide; a stabilization device comprising: a first leg having a first opening positioned along a first longitudinal axis of the first leg; a second leg having a second opening positioned along a second longitudinal axis of the second leg; and a V-shaped cross-member including two linear segments that meet at a vertex and coupling the first leg to the second leg; wherein at least one end of each of the first and second legs extend beyond an outermost edge of the cross-member along a longitudinal axis of the stabilization device; and an inserter device.
15. 15 . The stabilization device of claim 14 wherein the first opening engages the first alignment element.
16. 16 . The stabilization device of claim 14 wherein the second opening engages the second alignment element.
17. 17 . An orthopedic stabilization device comprising: a first cannulated leg defining a first longitudinal slot arranged in a wall of the leg and having a first opening; a second cannulated leg defining a second longitudinal slot arranged in a wall of the leg and having a second opening; and a V-shaped cross-member including two linear segments that meet at a vertex and coupling the first leg to the second leg; wherein the orthopedic stabilization device is configured to secure a target area of tissue during use.
18. 18 . An orthopedic implant system comprising: at least two stabilization devices comprising: a first cannulated leg defining a first longitudinal slot arranged in a wall of the leg and having a first opening; a second cannulated leg defining a second longitudinal slot arranged in a wall of the leg and having a second opening; and a V-shaped cross-member including two linear segments that meet at a vertex and coupling the first leg to the second leg; and at least two alignment elements for coupling to openings of legs; wherein a first of the at least two alignment elements couples the first legs of the at least two stabilization devices and a second of the at least two alignments couples the second legs of the at least two stabilization devices.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63/265,198, filed on Dec. 10, 2021, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD The present disclosure relates to the field of implants for use in medical procedures. In particular, stabilization devices described herein can be used to join target areas of tissue. BACKGROUND Devices and methods of stabilization of tissue for use in orthopedic procedures may include plates, staples, and devices having a solid body. Current staples consist of two or multi-leg devices with in-line compression and are meant to be used without discrimination across joint/bone surfaces. FIGS. 1-3 depict prior art staples. As shown in FIG. 1, staple 2 includes multiple legs 4. Bridging member 6 is formed such that distal ends 8 of legs 4 are closer together than ends 10 connected to bridging member 6. FIG. 2 depicts staple 12 positioned in tissue 14. Staples having bridges may cause soft tissue damage and/or irritation. As shown in FIG. 2, bridge 16 protrudes beyond tissue 14. Thus, site 18 indicates a potential location of irritation in the surrounding soft tissue. When in use, distal ends 20 of legs 22 of staple 12 are positioned further apart than ends 24 connected to bridging member 16. As shown in FIG. 2, positioning of the distal ends may affect the ability of the staples to couple target areas of tissue such that the distance between the target areas is equidistant. In some instances, this variable distance between the legs may cause uneven compression across the site of the tissue repair which may lead to delayed and/or malunion of the target areas of the tissue being repaired. The target areas of the tissue may include bone, bone segments and/or adjacent areas of bone. Further, as shown in FIG. 3, legs 26, 26′ have reduced torsional stability due to the geometry of staple 28 shown in FIGS. 2-3. In particular, staple 28 has a triangular shaped profile. Thus, there is a continuing need for an improved external fixator that can provide such adaptability. Implants for use in surgery need to be constructed in a manner that reduces or inhibits potential for irritation during use. Designs that provide surgeons with superior control, accuracy and performance are of particular interest. This results in reduced damage, heat and trauma to the tissues and leads to faster operations, more first-time results and an overall improvement in post-surgery healing. SUMMARY A stabilization device can include a first leg, a second leg substantially parallel to the first leg, and one or more cross-members coupling the first leg to the second leg. The one or more cross-members couple to the first and second legs at a predetermined distance from at least one end of each of the first and second legs. Each of the first and second legs includes an opening along longitudinal axes of the first and second legs. The first leg of stabilization device can be positioned substantially within a target area of tissue during use. In some instances, the first and second legs of the stabilization device are positioned completely within at least two target areas of tissue such that the stabilization device couples the at least two target areas of tissue during use. During use the one of more cross-members can extend from a first target area of tissue to a second target area of tissue at an interface of the first and second target areas. Further, during use the first leg can be positioned within the first target area and the second leg can be positioned within the second target area. The stabilization device can be secured to target tissue using one or more alignment elements during use. For example, the stabilization device can be secured to target tissue using one or more pins during use. In some instances, the first and second legs and the one or more cross-member of the stabilization device can be formed from a metal alloys. For example, the first and second legs and the one or more cross-members can be formed from Nitinol. An embodiment of a stabilization device can include a first leg and a second leg substantially parallel to the first leg. The stabilization device can also include one or more cross-members coupling the first leg to the second leg. The ends of each of the first and second legs can extend beyond an outermost edge of the cross-member such that a plane that includes a first end of the first leg and a first end of the second leg does not contact any of the one or more cross-members. In particular, the legs may extend beyond cross-member along a longitudinal axis of the legs. The stabilization device can include first and second legs and the one or more cross-members are formed from a metal alloy such as Nitinol. Each of the first and second legs of the stabilization device can include an opening along longitudinal axes of the first and second legs. The stabilization device ca