WO2016205351A1

WO2016205351A1 - System for tissue graft anchoring

Info

Publication number: WO2016205351A1
Application number: PCT/US2016/037601
Authority: WO
Inventors: Stephen Anthony SANTANGELO; James J. Kennedy, Iii; Alfred Rodrigue BERUBE, Jr.; Gary Robert Mccarthy; Mark Edwin Housman
Original assignee: Smith & Nephew, Inc.
Priority date: 2015-06-15
Filing date: 2016-06-15
Publication date: 2016-12-22

Abstract

A device for securing soft tissue includes a suture construct having a first end and a second end, a braided tubular portion formed from yarn and defining a lumen, the lumen being open at the first end, and a non-braided portion formed from the yarn at the second end. The non-braided portion forms a loop at the second end. A method of securing a graft includes placing a graft through the loop of the suture construct, pulling on the suture construct to locate the loop and graft in a bone tunnel, and placing a locking device within the lumen of the suture construct to secure the suture construct and graft in the bone tunnel.

Description

SYSTEM FOR TISSUE GRAFT ANCHORING

FIELD

This invention relates to tissue graft anchoring and a suture loop for anchoring tissue grafts.

BACKGROUND

An increasing number of surgical techniques are now performed arthroscopically. One type of arthroscopic procedure reconstructs the anterior cruciate ligament (ACL) in the knee. Several ACL reconstruction techniques are described in U.S. Pat. Nos. 5,139,520, 5,306,301, and 5,769,894, incorporated herein by reference in their entirety.

When the ACL has ruptured and is nonrepairable, it can be replaced using a substitute graft harvested from the patient or from a donor. The substitute ACL graft may be a portion of a patellar tendon or a semitendinosus and/or gracilis tendon graft. Alternatively, an artificial graft formed from synthetic materials or from a combination of artificial and natural materials may be used and is sometimes referred to as a ligament augmentation device (LAD). The term "tissue graft" is used herein to encompass all of these tissue replacements.

In general, the replacement tissue graft is placed within a passage formed within the femur and a passage formed in the tibia, and secured to the femur and tibia. Current graft anchoring devices, which fix the graft to bone, include fixed-length continuous and non- continuous loops of fiber attached to a solid button. The graft is placed through the loop of fiber, where it may be moved and secured by the device. It is therefore desirable to have a graft anchoring device that allows for adjustable positioning of the device, depending on the length of the bone passages and the graft.

SUMMARY

Described herein is a graft fixation device for securing soft tissue to bone. The graft fixation device includes a suture construct having a braided tubular portion formed from yarn and defining a lumen, and a non-braided portion formed from the same yarn. A locking device within the lumen secures the soft tissue to cortical bone. A method of securing a graft includes placing a graft through the loop of the suture construct and pulling on the suture construct to locate the loop and graft in a bone tunnel. The locking device can then be placed within the lumen of the suture construct to secure the suture construct and the graft in the bone tunnel. The method of this disclosure advantageously allows for the assembly of an infinitely adjustable device within the length of the associated suture construct with an integral continuous loop which is fixated with mechanical strength.

In one aspect, a graft fixation device for securing soft tissue includes a suture construct having a first end and a second end; a braided tubular portion formed from yarn and defining a lumen, the lumen being open at the first end; and a non-braided portion at the second end. The non-braided portion extends from the braided tubular portion and is formed from the yarn. The non-braided portion forms a loop at the second end. The graft fixation device includes a locking device sized for receipt within the lumen.

One or more of the following features may be included.

The locking device includes surface features. The surface features are threads or spiked tips. The locking device is formed from suture. The locking device includes pointed ends. A long dimension of at least a portion of the locking device is about 4 mm. A diameter of the braided tubular portion is about 5 mm to about 12 mm. The locking device includes at least one suture receiving hole. The graft fixation device includes at least one suture attached to the locking device.

According to another aspect, a method of securing a graft includes forming a bone tunnel in bone; placing a graft through a loop of a suture construct; pulling on the suture construct to locate the loop and graft in a bone tunnel; and placing a locking device within a lumen of the suture construct to secure the suture construct and graft in the bone tunnel.

One or more of the following features may be included.

Placing the graft includes placing the graft through a non-braided portion of the suture construct. Placing the locking device includes placing the locking device within a braided tubular portion of the suture construct. The bone tunnel includes a first portion extending through cortical bone and a second portion passing through cancellous bone. A diameter of the first portion is selected to the smaller than a diameter of the second portion. A long dimension of at least a portion of the locking device is selected to be larger than the diameter of the first portion of the bone tunnel. The long dimension of the at least a portion of the locking device is 4 mm. A diameter of the first portion of the bone tunnel is about 2.4 mm. A diameter of the second portion of the bone tunnel is between about 2.5 and 4.5 mm. Pulling on the suture construct to locate the loop and graft in a bone tunnel includes pulling on a suture attached to the suture construct through the bone tunnel. Placing a locking device within a lumen of the suture construct includes pulling on a suture attached to the locking device through the lumen of the suture construct.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and the drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

Objects, features and advantages will be apparent from the following more particular description of the embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the embodiments.

Fig. 1 shows an embodiment of a tissue graft implanted in a knee during an ACL reconstruction procedure and secured at one end by a graft fixation device including a suture loop.

Fig. 2 illustrates the tissue graft and the graft fixation device positioned in a femoral tunnel.

Fig. 3 is an illustration of the graft fixation device.

Figs. 4 and 5 depict an embodiment process for forming the closed loop suture.

Figs. 6 and 7 shows the tissue graft being implanted during an ACL reconstruction procedure.

Figs. 8 and 9 illustrate use of an alternative embodiment of a locking device of the graft fixation device.

Figs. 10 and 11A-11C illustrate additional alternative embodiments of locking devices.

Fig. 12 illustrates an additional alternative embodiment of a locking device. DETAILED DESCRIPTION

Embodiments of the graft fixation device and methods of use will now be discussed with reference to the figures.

In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different embodiments. To illustrate embodiment s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments.

Comprise, include, and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. And/or is open ended and includes one or more of the listed parts and combinations of the listed parts.

Referring to Fig. 1, a graft fixation device 10 secures soft tissue, for example, a tissue graft 12, within a knee 14 during an anterior cruciate ligament (ACL) repair and

reconstruction procedure. The graft fixation device 10, described in more detail below, can also be used to secure any suitable kind of graft, such as allografts, autografts, and xenografts and can be used in surgical soft tissue reconstruction procedures other than those related to ACL repair and reconstruction. For example, the graft fixation device 10 can be used for the fixation of tendons and ligaments during other orthopedic reconstruction procedures such as posterior cruciate ligament (PCL) repair and reconstruction, biceps tenodesis, distal biceps, and small joint procedures.

In Fig. 1, the graft fixation device 10 generally includes a suture loop 16 and a locking device 18 disposed within a suture construct 30, embodiments of which are described in more detail below. The tissue graft 12 is attached to the graft fixation device 10 by looping the tissue graft 12 through the suture loop 16. The tissue graft 12 is sized to fit within a femoral channel 20 formed in a femur 22 and a tibial channel 24 formed in a tibia 26. The femoral channel 20 extends through both the outer cortical bone 46 and the inner cancellous bone 47. The tissue graft 20 is secured to the femur 22 using the locking device 18, and is secured to the tibia 26 using another fastener 28 (for example, an interference screw, a post, or other fixation device). Referring to Fig. 2, the suture construct 30 of the graft fixation device 10 has a first end 32 and a second end 34. The suture construct 30 also has a braided tubular portion 36 formed from yarn 38 and defining a lumen 40. The braided tubular portion 36 has a diameter of, for example, about 5 mm to about 12 mm. The lumen 40 has an opening 42 at the first end 32. The suture construct 30 further has a non-braided portion 44 at the second end 34. The non-braided portion 44 extends from the braided tubular portion 36 and is formed from the yarn 38 that forms the braided tubular portion 36. The non-braided portion 44 forms the suture loop 16, which is located at the second end 34. The locking device 18 of the graft fixation device 10 is sized for receipt within the lumen 40 through the open end 42. The locking device 18 may be a button, plug, wedge or other appropriate device, and may have any suitable size or shape. The locking device 18 may be comprised of a metal, plastic, bioreabsorbable, braided or other suitable material.

One embodiment of a locking device 18 is shown in Fig. 3. In this embodiment, the locking device 18 has a threaded exterior surface 48, but the locking device 18 can also incorporate other surface features, such as ribs, barbs, spiked tips or the like, that capture the suture construct 30 so that the locking device 18 can slide into the suture construct 30 but not slip back out. The locking device 18 may further include a channel 49 for receipt of a drive tool (not shown).

Returning now to Fig. 2, in use, the locking device 18 is received within the lumen 40 of the braided tubular portion 36 from the opening 42 and secures the graft fixation device 10 against the cortical bone 46 of the femur 22 with the suture loop 16 extending into the femoral bone tunnel 20. The diameter of the femoral channel 20 is selected based on the size of the graft 12. A cortical tunnel portion 21 of the femoral channel 20 extends through the cortical bone 46. The diameter of the cortical tunnel portion 21 is selected to be smaller than the diameter of the remainder of the femoral channel 20. For example, the diameter of the femoral channel 20 may be about 4.5 mm or less, and the diameter of the cortical tunnel portion may be about 2.4 mm. The locking device 18 can include a portion with a diameter at least slightly larger than the diameter of the cortical tunnel portion 21 so that the locking device 18 does not pass through the cortical tunnel portion 21.

Referring to Fig. 4, a method of manufacturing the graft fixation device 10 includes forming a suture construct 50 having a first braided tubular portion 52 and a second braided tubular portion 54 spaced by a non-braided portion 56. The braided portions 52, 54 and the non-braided portions 56 can be manufactured, for example, using standard commercial braiding machinery, such as that described in U.S. Patent No. 8,881,635, hereby incorporated by reference. The process of forming the suture construct 50 includes, for example, braiding the first braided portion 52 using the braiding machine, stopping the braiding machine from braiding, while the braiding machine is stopped, pulling the yarns 38 that are loaded on the carriers of the braiding machine through the braiding machine to form the non-braided portion 56, and then again braiding the yarns 38 to form the second braided portion 54 using the braiding machine, as described in U.S. Patent No. 5, 147,400, which is hereby incorporated by reference. By following this process, the resulting suture construct 50 has the braided portions 52, 54 and the non-braided portion 56 formed from continuous yarns 38.

Referring now to Fig. 5, the method of manufacturing the graft fixation device 10 further includes forming the suture loop 16 of the non-braided portion 56 by placing an end 60 of the second braided portion 54 within a lumen 62 of the first braided portion 52 through an end 64, or further down the length, of the first braided portion 52, creating a looped-back portion 58. The looped-back portion 58 is woven, spliced or otherwise integrated into the first braided portion 52. In an alternative embodiment, the second braided portion 54 is not braided or tubular.

Referring to Fig. 6, a method of securing the tissue graft 12 using graft fixation device 10 includes placing the tissue graft 12 through the suture loop 16 of the graft fixation device 10 and pulling the graft fixation device 10 through the tibial channel 24 and the femoral channel 20 to locate the suture loop 16 and the attached tissue graft 12 in the femoral channel 20. The graft fixation device 10 can be pulled through the channels 20, 24 using, for example, a suture 70 which may be whip-stitched or otherwise attached to the proximal end of the braided tubular portion 36. As shown in Fig. 7, the locking device 18 is then advanced from the open end 42 through the lumen 40 of the braided tubular portion 36 and secured against the cortical bone 46. Excess length of the braided tubular portion 36 is then removed.

Other embodiments are within the scope of the following claims.

Referring to Fig. 8, another embodiment of a locking device 118 is formed by a radially expanding all suture device 120, such as described in U.S. Patent 8,795,334, hereby incorporated by reference. The locking device 118 includes a pull/ locating suture 122 and a deployment suture 124. Once the suture loop 16 is positioned in the femoral channel 20, the operator pulls on the suture 122 to advance the all suture device 120 through the lumen 40 until the all suture device 120 is at the entrance to the cortical tunnel portion 21 through the cortical bone 46. As shown in Fig. 9, the operator then pulls on the deployment suture 124 to expand the all suture device 120 and secure the graft 12 in the femoral channel 20.

Referring to Figs. 10 and 11 A, in another embodiment, a locking device 218a is in the shape of a crescent moon with end points 220a and first and second suture receiving holes 222a, 222b. In use, the locking device 218a, located within the braided tubular portion 36, is sized to be pulled through the femoral channel 20 along with the braided tubular portion 36, in this case facilitated by a pull suture 224 connected to the suture receiving hole 222a. Once the locking device is pulled through the cortical bone 46, a deployment suture 226, also connected to suture receiving hole 222a and located within the femoral channel 20, is pulled to flip the locking device 218a from a vertical orientation to a horizontal orientation, as viewed in Fig. 10. An additional escape suture 228 can be connected to the second suture receiving hole 222b. In the horizontal orientation, the end points 220a engage the braided tubular portion 36. At least a portion of the long dimension of the locking device 218a, being, for example, about 4 mm, is longer than the diameter of the cortical tunnel portion 21 (i.e., about 2.4 mm). The tension placed on the braided tubular portion 36 by the tissue graft 12 is resisted by the locking device 218a being up against the surface of the cortical bone 46, thus holding the locking device 218a in place to secure the tissue graft 12.

Alternatives to locking device 218a are illustrated in Figs. 1 IB and 11C. In Fig. 1 IB, embodiments of locking devices 218b include flex wings 230 with end points 220b. In Fig. 11C, a locking device 218c is boat-shaped with end points 220c.

As illustrated in Fig. 12, in another embodiment, a locking device 318 has a generally bottle cap shape with spike type features 320 to engage the braided tubular portion 36. The locking device 318 can be introduced into the braided tubular portion 36 from the outside in after the braided tubular portion 36 is pulled through the femoral channel 20. Alternatively, if a hinge (not shown) is included in the locking device 318, the locking device 318 can be internal to the braided tubular portion 36 while the braided tubular portion 36 is passed through the femoral channel 20. In either configuration, the locking device 318 is pulled down to the cortical bone 46 using knotted sutures 322, 324 previously attached to the locking device 318.

Although the present disclosure has been described with respect to various embodiments, it would be apparent to one of ordinary skill in the art that various other embodiments are possible, without departing from the spirit and scope as defined in the appended claims.

Claims

CLAIMS What is claimed is:

1. A graft fixation device for securing soft tissue to bone, the device comprising:

a suture construct comprising:

a first end and a second end;

a braided tubular portion formed from yarn and defining a lumen, the lumen being open at the first end;

a non-braided portion at the second end, the non-braided portion extending from the braided tubular portion and being formed from the yarn, the non-braided portion forming a loop at the second end; and

a locking device sized for receipt within the lumen of the braided tubular portion.

2. The device of claim 1 wherein the locking device includes surface features.

3. The device of claim 2 wherein the surface features are threads.

4. The device of claim 2 wherein the surface features are spiked tips.

5. The device of claim 1 wherein the locking device is formed from suture.

6. The device of claim 1 wherein the locking device includes pointed ends.

7. The device of claim 1 wherein a long dimension of at least a portion of the locking device is about 4 mm.

8. The device of claim 1 wherein a diameter of the braided tubular portion is about 5 mm to about 12 mm.

9. The device of claim 1 wherein the locking device comprises at least one suture receiving hole.

10. The device of claim 1 further comprising at least one suture attached to the locking device.

11. A method of securing a graft in a bone tunnel, the method comprising:

forming a bone tunnel in a bone;

placing a graft through a loop of a suture construct;

pulling on the suture construct to locate the loop and graft in the bone tunnel; and placing a locking device within a lumen of the suture construct to secure the suture construct and graft in the bone tunnel.

12. The method of claim 11 wherein placing the graft comprising placing the graft through a non-braided portion of the suture construct.

13. The method of claim 11 wherein placing the locking device comprising placing the locking device within a braided tubular portion of the suture construct.

14. The method of claim 11 wherein the bone tunnel comprises a first portion extending through cortical bone and a second portion passing through cancellous bone, a diameter of the first portion selected to the smaller than a diameter of the second portion.

15. The method of claim 11 wherein a long dimension of at least a portion of the locking device is selected to be larger than the diameter of the first portion of the bone tunnel.

16. The device of claim 11 wherein a long dimension of at least a portion of the locking device is about 4 mm.

17. The method of claim 11 wherein a diameter of the first portion of the bone tunnel is about 2.4 mm.

18. The method of claim 11 wherein a diameter of the second portion of the bone tunnel is between about 2.5 and 4.5 mm.

19. The method of claim 11 wherein pulling on the suture construct to locate the loop and graft in a bone tunnel comprises pulling on a suture attached to the suture construct through the bone tunnel.

20. The method of claim 11 wherein placing a locking device within a lumen of the suture construct comprises pulling on a suture attached to the locking device through the lumen of the suture construct.