Methods and devices for treating a syndesmosis injury

• US 9,138,219 B2
• Filed: 07/15/2011
• Issued: 09/22/2015
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: Tarsus Medical Incorporated (Integra LifeSciences Holdings Corporation)
• Original Assignee: Tarsus Medical Incorporated (Integra LifeSciences Holdings Corporation)
• Inventors: Sand, Paul M., Keith, Peter, Lofthouse, Trevor, Mourlas, Nick, Roop, John Avi, Lettmann, Jason W., Horrell, Chuck
• Primary Examiner(s): Lawson, Matthew
• Assistant Examiner(s): KU, SI MING
• Application Number:
  US13/183,818
• Publication Number:
  US 20120172936A1
• Time in Patent Office: 1,530 Days
• Field of Search: 606300-321, 623 1313- 1316
• US Class Current: 1/1
• 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 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/844 with expandable anchors or anchors having movable parts
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61B 17/8891 at its periphery
• 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 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61F 2/4202 for ankles

Abstract

Embodiments relate to implantable devices for the treatment of syndesmosis injuries. Embodiments include a first anchor attachable to a first bone, the first anchor being coupled to a flexible component, the flexible component in turn being coupled to a base component. The base component may be rigid, and may be externally threaded for engaging with a second anchor. Position of the second anchor may be adjusted by rotating the second anchor with respect to the base component, thereby adjusting relative position of the two bones. An assembly may be created in which an outer tube contains the flexible component and the base component inside the outer tube, and at its distal end the outer tube may engage the first anchor so as to allow transmission of torque. The outer tube may be withdrawn proximally after implantation of the first anchor. The bones may be a tibia and a fibula.

Claims

1. A method of treating a syndesmosis injury, comprising:

forming a hole through a second bone and into a first bone;

inserting a deployment assembly into the hole in the second bone, the deployment assembly comprising;

(a) an outer tube having a distal end, a proximal end, an outer diameter, and an inner diameter

(b) a tether disposed within the outer tube, the tether comprising;

(i) a flexible component; and

(ii) a base component coupled to the flexible component, said base component being substantially rigid, the base component having a distal portion that is externally threaded having a base component external thread having a base component external thread major diameter, and having a proximal portion; and

(c) a first bone anchor disposed at a distal end of the outer tube, the first bone anchor having a first bone anchor external thread having a first bone anchor external thread major diameter, the first bone anchor being coupled to a distal end of the flexible component, wherein the outer tube has a torque-transmitting engagement feature cooperating with the first bone anchor;

positioning the first bone anchor in the first bone;

removing the outer tube; and

coupling a second anchor to the base component and positioning the second anchor in the second bone or in a plate connected to the second bone,

wherein the first bone anchor external thread major diameter is greater than the outer tube outer diameter at the distal end, the outer tube outer diameter is greater than the outer tube inner diameter, the outer tube inner diameter is greater than the base component external thread major diameter, and the base component proximal portion is sufficiently narrow so that the second anchor can advance non-rotatingly along the proximal portion of the base component.

2. The method of claim 1, wherein the positioning the first bone anchor further comprises rotating the deployment assembly to screw the first bone anchor into the first bone.

3. The method of claim 1, further comprising urging the second anchor distally in relation to the tether, wherein urging the second anchor distally comprises sliding the second anchor distally along the proximal portion of the base component, followed by engaging an internal thread of the second anchor with the base component external thread, followed by rotating the second anchor with respect to the base component to further advance the second anchor distally, and further comprising severing an extending portion of the base component so that a remaining portion of the base component does not protrude beyond the second anchor.

4. The method of claim 1, further comprising first positioning a guide wire through the second bone and into the first bone, wherein the forming the hole in the second bone further comprises positioning a drill over the guide wire and drilling the hole in the second bone.

5. A method of treating a syndesmosis injury, comprising:

forming a hole through a second bone and into a first bone;

inserting an implantation tool comprising a deployment assembly into said hole in said second bone, said deployment assembly comprising;

a first bone anchor, said first anchor being suitable for placement in said first bone, said first bone anchor having a first anchor external thread having a first anchor external thread major diameter, said first bone anchor having at its proximal end a coupling feature;

an outer tube having a lumen therewithin and having, at its distal end, a protrusion capable of being received in said coupling feature of said first anchor;

a tether comprising a flexible component coupled to said first bone anchor and a base component coupled to said flexible component, said base component being substantially rigid,

wherein when the outer tube is coupled with the first bone anchor said first bone anchor is disposed distally of said outer tube and said base component is contained entirely within said lumen of said outer tube and does not extend beyond a proximal end of the implantation tool;

positioning said first bone anchor in said first bone;

removing said outer tube; and

coupling a second anchor to a proximal end of said base component and positioning said second anchor in said second bone or in a plate connected to said second bone,

wherein a distal portion of the base component has an external thread and a proximal portion of the base component is unthreaded, and wherein the second anchor has an internal thread engageable with the external thread of the base component, and wherein the unthreaded portion of the base component is sufficiently long so that when the second anchor, while engaged with a driver tool having a central bore therethrough, begins to engage the external thread of the base component, some of the base component protrudes proximally from the driver tool.

6. The method of claim 5, further comprising first positioning a guide wire through said second bone and into said first bone, wherein the forming said hole in said second bone further comprises positioning a drill over said guide wire and drilling said hole in said second bone.

7. The method of claim 5, wherein the positioning said first bone anchor in said first bone further comprises rotating said deployment assembly to screw said first bone anchor into said first bone.

8. The method of claim 5, wherein positioning said first bone anchor into said first bone further comprises positioning said first bone anchor into said first bone such that said proximal end of said first bone anchor is substantially flush with a surface of said first bone.

9. The method of claim 5, further comprising, after said coupling said second anchor to said proximal end of said base component, urging said second anchor distally in relation to said tether, thereby urging said second anchor toward said first borne anchor.

10. The method of claim 9, wherein urging the second anchor distally in relation to the tether further comprises rotating the second anchor with respect to said base component.

11. The method of claim 5, wherein said flexible component comprises a suture.

12. The method of claim 5, wherein said flexible component comprises a resorbable suture.

13. The method of claim 5, wherein said flexible component has a strength such that said flexible component fails before either said first bone anchor or said second anchor is pulled from a respective implantation site.

14. The method of claim 5, wherein said outer tube does not extend radially beyond said major diameter of said external threads of said first bone anchor.

15. The method of claim 5, further comprising:

examining a radiographic image to determine an initial position of said second bone in relation to said first bone; and

adjusting the positioning of said second anchor based on said initial position of said second bone in relation to said first bone to achieve a desired position.

16. The method of claim 5, further comprising:

evaluating ankle function to determine an initial position of said second bone in relation to said first bone; and

adjusting the positioning of the second anchor based on the initial position of said second bone in relation to the first bone to achieve a desired position.

17. The method of claim 5, wherein said first bone is the tibia bone and said second bone is the fibula bone.

18. A method of treating a syndesmosis injury, comprising:

forming a hole through a second bone and into a first bone;

inserting a deployment assembly into said hole in said second bone, said deployment assembly comprising;

a first anchor, said first anchor being suitable for placement in said first bone, said first anchor being distally located;

a tether, said tether comprising a flexible component and a base component, wherein said base component is substantially rigid, wherein said first anchor is coupled to said flexible component, and said flexible component is coupled to said base component, and said base component extends more proximally than said flexible component, and wherein said base component has an external thread and a proximal portion of the base component is unthreaded;

positioning said first anchor in said first bone; and

coupling a second anchor to a proximal end of said base component, wherein said second anchor has an internal thread complementary to said base component external thread; and

positioning said second anchor in said second bone or in a plate connected to said second bone,

wherein the unthreaded portion of the base component is sufficiently long so that when the second anchor, while engaged with a driver tool having a central bore therethrough, begins to engage the external thread of the base component, some of the base component protrudes proximally from the driver tool.

19. The method of claim 18, further comprising removing an excess length from said proximal portion of said base component.

20. The method of claim 18, wherein positioning said second anchor in said second bone comprises rotating said second bone anchor with respect to said base component.

21. The method of claim 18, wherein said flexible component comprises a resorbable suture.

22. The method of claim 18, further comprising, after said positioning said second anchor in said second bone, evaluating a relative position of said bones, and re-positioning said second anchor to achieve desired positioning of said bones.

23. The method of claim 18, wherein said second anchor comprises a head having a curved underside of said head between a top of said head and a body of said second anchor, wherein said curved underside has a shape that corresponds to a shape of a hole in said plate.

24. A method of treating a syndesmosis injury, comprising:

forming a hole through a second bone and into a first bone;

inserting a deployment assembly into said hole in said second bone, said deployment assembly comprising;

an outer tube having an outer diameter and an inner diameter and having a lumen therewithin and having, at its distal end, a protrusion;

a first anchor located distally of said distal end of said outer tube, said first anchor being suitable for placement in said first bone, said first anchor having an external thread having a major diameter, said first anchor having a coupling feature located within said major diameter and capable of receiving said protrusion of said outer tube;

a tether comprising a flexible component coupled to said first anchor and a base component coupled to said flexible component, said base component being substantially rigid,

wherein some of said base component is more proximal than said flexible component,

wherein said base component has a base component external thread,

wherein said base component fits inside said lumen of said outer tube;

positioning said first anchor in said first bone, wherein said positioning comprises applying torque to said outer tube causing rotation and advancement in a distal direction of said first anchor;

withdrawing said outer tube in a proximal direction while said flexible component remains coupled to said first anchor and said base component remains coupled to said flexible component; and

coupling a second anchor to said base component and positioning said second anchor in said second bone or in a plate connected to said second bone, wherein said second anchor has an internal thread complementary to said base component external thread, wherein said coupling includes rotating said second anchor with respect to said base component,

wherein the first bone anchor external thread major diameter is greater than the outer tube outer diameter at the distal end, the outer tube outer diameter is greater than the outer tube inner diameter, the outer tube inner diameter is greater than the base component external thread major diameter, and the base component further comprises a proximal portion that is sufficiently narrow so that the second bone anchor can advance non-rotatingly along the proximal portion of the base component.