# Patent

## Title
Manual soft tissue T-shape tensioning device

## Abstract

A soft tissue tensioning system comprises a manual suture tensioning device having a bar and a finger guard which is orthogonal to the bar. A lateral suture cleat is disposed on each lateral end of the bar, and a primary suture cleat extends about a top and a bottom of each of the opposed lateral ends of the bar.

## Background
This application is a divisional application under 35 U.S.C. 120 of commonly assigned U.S. patent application Ser. No. 12/437,020, entitled Manual Soft Tissue Tensioning Systems and Methods, filed on May 7, 2009, now U.S. Pat. No. 8,123,806, issued on Feb. 28, 2012, which in turn claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/052,136, entitled Manual Soft Tissue Tensioner, filed on May 9, 2008. Each of the above referenced applications are expressly incorporated herein by reference, in their entirety.


BACKGROUND OF THE INVENTION
The present invention relates generally to devices, systems and methods for material fixation, and, more particularly, to suture management and tensioning devices used during soft tissue reconstruction or bone-to-bone fixation that will assist in the repair of many soft tissue injuries, such as in the reconstruction of the Anterior Cruciate Ligament (ACL).
Prior to completing the final steps of fixation during an ACL repair, the reconstructed ligament must be tensioned in order to establish joint stability. In The tendons of the Gracilis and Semitendinosus muscles are commonly harvested for use in ACL reconstruction. The tendons are doubled over to create a four strand graft complex. During ACL reconstruction the strands are sutured to form a paired complex of either of two strands sutured together. The strength and stiffness of the graft complex typically surpass that of the native ACL, and both characteristics are optimized when a relatively even tension is applied to each of the four tendon strands. The assignee of the present application has disclosed exemplary ACL repair systems and procedures, particularly, for example, in co-pending commonly assigned U.S. patent application Ser. No. 11/725,981, entitled Method and Apparatus for Attaching Soft Tissue to Bone, filed on Mar. 20, 2007, and Ser. No. 11/923,526, entitled Methods and Systems for Material Fixation, filed on Oct. 24, 2007. Both of these prior applications are herein expressly incorporated by reference in their entirety. It would be advantageous to have a convenient and easily usable suture tensioning device and methods for tensioning the graft complex when practicing ACL techniques of this nature.
SUMMARY OF THE INVENTION
The present invention is a manual suture tensioning device and method for use in surgical procedures for repairing soft tissue, and more particularly for use in arthroscopic procedures of this nature.
The inventive device and methods comprise an adjustable, standalone tensioning system that requires no additional fixturing, weights, or bone surface modification, and allows a single operator to provide an adjustable and repeatable tension to a soft tissue graft, and to install the final fixation implant. Its design facilitates introduction of the suture component of the graft into the tensioning process by simplifying retention of the suture. An even, regulated and reproducible tension is easily achieved. Furthermore, the benefits of the device's suture management system, coupled with its ability to maintain tension on the graft, minimizes obstructions surrounding the installation site and eases installation of the final fixation implant. Therefore, most surgeons will be able to use the device without requiring additional assistance during the tensioning and final fixation procedure.
More particularly, there is provided a soft tissue tensioning system, which comprises a manual suture tensioning device having a generally T-shape. The device comprises a bar and a finger guard which is orthogonal to the bar, wherein the bar has opposed lateral ends. A lateral suture cleat is disposed on each lateral end of the bar, and a primary suture cleat extends about a top and a bottom of each of the opposed lateral ends of the bar. Each primary suture cleat comprises a pair of slots, wherein each of the pair of slots extend about top and bottom portions of the bar. Each lateral suture cleat comprises a slot which intersects each of the pair of slots forming each primary suture cleat. Each lateral suture cleat slot extends vertically on its respective bar end.
Preferably, the manual suture tensioning device is molded of a plastic material. The finger guard comprises a central cannula extending therethrough, with opposed openings on each end thereof. The finger guard extends orthogonally from an approximate center portion of the bar.
The inventive system preferably further comprises a driver having a shaft and a distal working end adapted for engaging and actuating a portion of a fixation implant.
In another aspect of the invention, an inventive method of tensioning suture in connection with an orthopedic repair procedure comprises a step of inserting a first suture bundle extending from a tissue graft into a first lateral cleat on a first end of a bar forming part of a manual suture tensioning device. A second suture bundle extending from the tissue graft is inserted into a second lateral cleat on a second opposing end of the bar. The first suture bundle is wrapped around a first primary cleat disposed on the first end of the bar, and the second suture bundle is wrapped around a second primary cleat disposed on the second end of the bar. Once each of the suture bundles are in place, the user grasps the bar and evenly applies manual tension to each of the first and second suture bundles.
The manual suture tensioning device also comprises a finger guard orthogonally disposed relative to the bar. The above noted grasping step includes a step of grasping both the bar and the finger guard, with the finger guard placed between fingers of the user during the grasping step.
Each of the first and second primary suture cleats comprises a pair of slots extending about top and bottom portions of the bar, and each of the first and second lateral cleats comprises a slot extending vertically on its respective bar end. As a result, the arrangement of slots is such that the corresponding primary and lateral suture cleats intersect, and the respective wrapping steps comprise wrapping the respective suture bundle over itself.
In some procedures, the inventive method may also comprise a step of deploying a fixation implant in a bone opening. A fixation screw is placed onto a driver, and the fixation screw into the fixation implant. A cannula preferably extends through the finger guard. The inserting step may include a further step of disposing the driver through the cannula. Alternatively, the driver may be disposed above or below the manual suture tensioning device. Once in place the driver may be rotated to tighten the fixation screw, and thus secure the fixation implant in place.
Finally, the driver and the manual suture tensioning device are withdrawn from the procedural site. To complete the procedure, once the tissue graft is tensioned as desired, the suture bundles are cut from the manual suture tensioning device and secured by knots or other appropriate methods.
The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a manual soft tissue tensioner constructed in accordance with the principles of the present invention;
FIG. 2 is a plan view of the tensioner of FIG. 1;
FIG. 3 is a top view of the tensioner of FIGS. 1 and 2;
FIG. 4 is a plan view illustrating a first step in performing a suture tensioning method using the device shown in FIGS. 1-3;
FIG. 5 is a plan view similar to FIG. 4 illustrating a second step in performing a suture tensioning method using the device shown in FIGS. 1-3;
FIG. 6 is a plan view similar to FIGS. 3-4, illustrating a third step in performing a suture tensioning method using the device shown in FIGS. 1-3;
FIG. 7 is a plan view of the opposing side of the device shown in FIGS. 1-3, as the third step illustrated in FIG. 6 is being performed;
FIG. 8 is a view showing an implant being inserted into the tibial tunnel during a soft tissue reconstruction procedure while even suture tension is being maintained;
FIG. 9 is a view showing a driver being engaged with a fixation screw on the implant;
FIG. 10 is a view showing the driver shaft being inserted through the central cannulation of the device of FIGS. 1-3;
FIG. 11 is a view similar to FIG. 10 showing an alternative approach wherein the driver shaft is disposed above or below the tensioning bar;
FIG. 12 is a view showing the fixation screw being screwed into the tibial implant; and
FIG. 13 is a view showing the completed procedure, with fixation being complete and manual tension being removed from the implant site.



DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention is a manual suture tensioning device and method for use in surgical procedures for repairing soft tissue, and more particularly for use in arthroscopic procedures of this nature. This disclosure particularly relates to anterior cruciate ligament (ACL) repair procedures, as disclosed in co-pending commonly assigned U.S. patent application Ser. No. 11/725,981, entitled Method and Apparatus for Attaching Soft Tissue to Bone, filed on Mar. 20, 2007, and Ser. No. 11/923,526, entitled Methods and Systems for Material Fixation, filed on Oct. 24, 2007. Both of these prior applications are herein expressly incorporated by reference in their entirety.
Now referring more particularly to the drawings, there is shown in FIGS. 1-3 a manual suture tensioning device 10 which is preferably molded of a suitable plastic material and is configured in a T-shape. The device 10 comprises a bar 12 and a finger guard 14 which is orthogonal to the bar 12. A central cannula 16 extends through the finger guard 14 and bar 12, with openings on each opposed end thereof. Each lateral end of the bar 12 comprises two different types of suture cleats, a lateral suture cleat 18 on the end thereof, and a primary suture cleat 20 extending about the top and bottom thereof. The primary suture cleat 20 preferably comprises a pair of slots 22, and the slot forming the lateral cleat 18 intersects each of these slots 22.
Referring to FIGS. 4-13, a method of tensioning suture in conjunction with an orthopedic repair procedure is illustrated sequentially. In FIG. 4, a first step in the method is to insert sutures 24 extending from a tissue graft, which in a preferred procedure comprises a tendon bundle 26 (FIG. 8), into the lateral cleats 18 on each end of the bar 12. The suture 24 is then wrapped around the primary cleats 20, in a direction shown by arrow 28, simultaneously wrapping over itself, as shown in FIG. 5.
As shown in FIGS. 6 and 7, from opposing directions, a next step in the inventive method is to grasp the bar 12 and finger guard 14, between the respective opposing suture cleats 20, and to evenly apply manual tension to both suture bundles 24. The finger guard 14 is preferably placed between adjacent fingers, as illustrated.
In FIG. 8, there is shown a patient's femur 30 and tibia 32, into which the aforementioned tendon bundle 26 has been placed, in accordance with the procedure described and shown in co-pending U.S. patent application Ser. Nos. 11/725,981 and 11/923,526, already expressly incorporated herein by reference. At this juncture, a femoral implant (not shown) for securing the tendon bundle within a tunnel in the femur 30 has already been inserted and deployed. A tibial implant 34 is inserted into a tunnel in the tibia 32, as shown, between the tendons in the tendon bundle 26, while even suture tension is maintained using the suture tensioning device 10. A deployment tool 36 is utilized to deploy the implant 34. Following this step, a fixation screw 38 (FIG. 9) is placed onto a driver 40.
In FIG. 10, there is shown a procedural step of placing the driver shaft 40 through the central cannula 16 of the finger guard 14. Then, the fixation screw 38 is inserted into the tibial implant 34, as shown. Alternatively, as illustrated in FIG. 11, the driver shaft 40 may be placed above or below the tensioning device 10. Once the fixation screw 38 is in place, it is tightened by rotating the driver 40 in a clockwise direction, as shown in FIG. 12 to secure the implant in position. Then, as illustrated in FIG. 13, the tool 40 and manual tensioning device 10 may be disengaged from the fixation screw 38 and suture 24 and withdrawn from the procedural site.
It is to be understood that the figures of the bone and anchors seen above are purely illustrative in nature, and are not intended to limit the application of the inventive embodiments to any particular physiological application or purpose. The invention is applicable to many different types of procedures involving, in particular, the attachment of connective or soft tissue to bone. All of the terms used herein are descriptive rather than limiting, and many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.

## Claims

1. A soft tissue tensioning system, comprising:
a manual suture tensioning device having a generally T-shape, said device comprising a bar and a finger guard which is orthogonal to the bar, said bar having opposed lateral ends;
a lateral suture cleat disposed on each lateral end of the bar and having a depth extending through the bar toward the finger guard, forming a slot; and
a primary suture cleat extending about a top and a bottom of each of said opposed lateral ends of said bar and comprising a slot which intersects with its corresponding lateral suture cleat.

2. The soft tissue tensioning system as recited in claim 1, wherein each primary suture cleat comprises a pair of slots.

3. The soft tissue tensioning system as recited in claim 2, wherein each of said pair of slots forming each said primary suture cleat extend about top and bottom portions of said bar.

4. The soft tissue tensioning system as recited in claim 1, wherein each said lateral suture cleat slot extends vertically on its respective bar end.

5. The soft tissue tensioning system as recited in claim 4, wherein said manual suture tensioning device is molded of a plastic material.

6. The soft tissue tensioning system as recited in claim 1, wherein said finger guard comprises a central cannula extending therethrough, with opposed openings on each end thereof.

7. The soft tissue tensioning system as recited in claim 6, wherein said finger guard extends orthogonally from an approximate center portion of the bar.

8. The soft tissue tensioning system as recited in claim 1, and further comprising a driver having a shaft and a distal working end adapted for engaging and actuating a portion of a fixation implant.

9. A soft tissue tensioning system, comprising:
a manual suture tensioning device having a generally T-shape, said device comprising a bar and a finger guard which is orthogonal to the bar, said bar having opposed lateral ends, wherein said finger guard comprises a central cannula extending therethrough, with opposed openings on each end thereof;
a lateral suture cleat disposed on each lateral end of the bar; and
a primary suture cleat extending about a top and a bottom of each of said opposed lateral ends of said bar.

10. The soft tissue tensioning system as recited in claim 9, wherein said finger guard extends orthogonally from an approximate center portion of the bar.

11. The soft tissue tensioning system as recited in claim 9, and further comprising a driver having a shaft and a distal working end adapted for engaging and actuating a portion of a fixation implant.

12. The soft tissue tensioning system as recited in claim 9, wherein each primary suture cleat comprises a pair of slots.

13. The soft tissue tensioning system as recited in claim 12, wherein each said pair of slots extend about top and bottom portions of said bar.

14. The soft tissue tensioning system as recited in claim 12, wherein each lateral suture cleat comprises a slot which intersects each of the pair of slots forming each primary suture cleat.

15. The soft tissue tensioning system as recited in claim 14, wherein each said lateral suture cleat slot extends vertically on its respective bar end.

16. The soft tissue tensioning system as recited in claim 15, wherein said manual suture tensioning device is molded of a plastic material.