Compression and tension instruments and methods of use to reinforce ligaments

• US 10,426,460 B2
• Filed: 07/05/2017
• Issued: 10/01/2019
• Est. Priority Date: 07/05/2016
• Status: Active Grant

• Current Assignee: Crossroads Extremity Systems, Llc (Johnson & Johnson)
• Original Assignee: Mortise Medical, LLC
• Inventors: Taber, Justin, Fallin, T. Wade, Phisitkul, Phinit
• Primary Examiner(s): Boles, Sameh R
• Application Number:
  US15/642,053
• Publication Number:
  US 20180008330A1
• Time in Patent Office: 818 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 17/8869 Tensioning devices
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0403 Dowels other bone dowels A61B17/68; dowels for connecting prosthetic parts A61F2002/30433
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for

Abstract

The disclosure provides apparatus and methods of use pertaining to syndesmosis reinforcement. Embodiments include a clamp having two jaws that extend toward each other to clamp two bone portions therebetween. The clamp may include an angle gauge and an adjustment mechanism having a force gauge that combine to enable the compression of the two bone portions in an optimal direction or angle and at an optimal, measurable compression force. Embodiments also include a tension instrument configured to knotlessly lock a flexible strand construct between two anchors at the same optimal direction and tension applied by the clamp. Further embodiments include an exemplary syndesmosis reinforcement procedure that employs the clamp and the tension instrument to construct a ligament reinforcement construct that achieves optimal anatomic positioning in both directional alignment and the reduction force applied by the construct. Other embodiments are disclosed.

Claims

1. A clamp for compressing first and second bone portions together to reduce a space therebetween, comprising:

a body comprising opposing first and second ends, the first and second ends comprising respective first and second jaws that define a longitudinal clamp axis, the first jaw engageable with the first bone portion and the second jaw engageable with the second bone portion to define a directional force vector between the first and the second bone portions that is parallel with the longitudinal clamp axis; and

an adjustment mechanism coupled with the second jaw and configured to translate the second jaw distally toward the first jaw along the longitudinal axis to compress the first and the second bone portions between the first and the second jaws, the adjustment mechanism including a force gauge configured to indicate a compression force placed upon the first and the second bone portions by the first and the second jaws along the directional force vector, wherein;

the body forms a bow-shaped angle gauge presenting a series of angle indicia; and

when a reference line defined by a portion of a patient'"'"'s anatomy aligns with a zero-degree marking on the angle indicia, the reference line is perpendicular to the longitudinal clamp axis and the directional force vector.

2. The clamp of claim 1, wherein the clamp further comprises a guide configured for insertion of a drill to form coaxial bone tunnels, parallel with the longitudinal clamp axis, in the first and second bone portions.

3. The clamp of claim 1, wherein the adjustment mechanism includes a gross adjustment control and a fine adjustment control.

4. The clamp axis of claim 1, wherein the clamp includes finger grips and a thumb grip configured to enable one-handed operation to apply compression force.

5. The clamp of claim 1, wherein the clamp includes a release trigger configured to release compression force.

6. The clamp of claim 5, wherein the release trigger is configured to enable one-handed operation for both application of compression force and release of compression force.

7. The clamp of claim 1, wherein the longitudinal clamp axis and the directional force vector are parallel with a native ligament extending between the first and the second bone portions.

8. The clamp of claim 1, wherein the angle indicia on either side of the zero-degree marking indicate an amount of angular deviation between the reference line and the perpendicular.

9. The clamp of claim 1, wherein the first jaw comprises a v-notch configured to register directly upon the first bone portion.

10. The clamp of claim 1, wherein the first jaw comprises a spherical end configured to register upon a bone plate coupled with the first bone portion.

11. The clamp axis of claim 10, wherein the clamp further comprises a guide configured for insertion of a drill to form coaxial bone tunnels, parallel with the longitudinal clamp axis, in the first and second bone portions, wherein the coaxial bone tunnels are coaxial with a hole in the bone plate.

12. The clamp of claim 1, wherein the longitudinal guide comprises a pin, a drill, or a length of k-wire.

13. A clamp for compressing first and second bone portions together to reduce a space therebetween, comprising:

a body comprising opposing first and second ends, the first and second ends comprising respective first and second jaws that define a longitudinal clamp axis, the first jaw engageable with the first bone portion and the second jaw engageable with the second bone portion to define a directional force vector between the first and the second bone portions that is parallel with the longitudinal clamp axis; and

an adjustment mechanism coupled with the second jaw and configured to translate the second jaw distally toward the first jaw along the longitudinal axis to compress the first and the second bone portions between the first and the second jaws, the adjustment mechanism including a force gauge configured to indicate a compression force placed upon the first and the second bone portions by the first and the second jaws along the directional force vector, wherein the first end of the body comprises;

a C-shaped arm that is coaxial with the longitudinal clamp axis; and

a sheath rotatively coupled about the C-shaped arm, the sheath forming a U-shaped groove that is coaxial with the longitudinal clamp axis, wherein;

when the sheath is rotated into a closed configuration, a wall of the C-shaped arm aligns with the U-shaped groove such that the U-shaped groove is configured to receive and retain a longitudinal guide; and

when the sheath is rotated into an open configuration, an opening of the C-shaped arm aligns with the U-shaped groove such that the clamp is transversely removable from the first and the second bone portions and the longitudinal guide.