WO2013114347A1

WO2013114347A1 - Suture anchor with cleat formation to secure suture thread

Info

Publication number: WO2013114347A1
Application number: PCT/IB2013/050951
Authority: WO
Inventors: Daniel Johannes PIENAAR
Original assignee: Implament Pty Limited; Van Der Walt, Louis, Stephanus
Priority date: 2012-02-05
Filing date: 2013-02-05
Publication date: 2013-08-08

Abstract

A suture anchoring device (10,50,70,120) for lockingly accommodating one or more suture threads is provided. The device comprises an elongate body (12,12',12"12"'), the body defining a cleat formation (14, 14', 14", 14"') comprising an enlarged entrance opening for receiving the suture threads and a relatively narrower slit (18, 18', 18", 18"') extending from the entrance opening in which the suture threads can be lockingly secured. The body defines a proximal end and a distal end that includes the cleat formation. In an embodiment, the body comprises two complementary protrusions (24, 26, 24', 26', 24"', 26"') extending from the distal end of the body, the two protrusions being substantially parallel to each other and defining at least the entrance opening of the cleat formation. In an embodiment, the entrance opening comprises a tapering wedge formation (28, 28', 28"') that tapers from the distal end of the body towards the slit.

Description

SUTURE ANCHOR WITH CLEAT FORMATION TO SECURE SUTURE THREAD

FIELD OF THE INVENTION This disclosure relates to a threaded suture anchoring device for lockingly accommodating one or more suture threads, which in turn may be used to, for example, secure or re-fit a muscle, tendon, ligament or other soft tissue to a bone in which the anchoring device is located.

BACKGROUND TO THE INVENTION

As the treatment of injuries to joints and soft tissue has progressed in the orthopaedic medical arts, there has been a need for medical devices which can be used to attach tendons, ligaments and other soft tissue to bone. When surgically repairing an injured joint, it is preferable to restore the joint by reattaching the damaged soft tissue rather than replacing it with an artificial material equivalent. Such restorations typically require the attachment of soft tissue, such as ligaments and tendons, to bone. Various devices, including sutures, screws, staples, wedges, and plugs have been used in the past to reattach soft tissue to bone.

Recently, various types of threaded suture anchors have been developed for this purpose. Some threaded suture anchors are designed to be inserted into a pre- drilled hole. Other suture anchors are self-tapping.

U.S. Patent No 5, 156,616, for example, discloses a suture anchor having an axial passageway extending through the suture anchor. The passageway has a proximal portion, a central portion, and a distal portion. The proximal portion is hexagonally-shaped to cooperate with a hex driver for installing the anchor. The distal portion is sized to receive a knotted piece of suture, and the central portion has a diameter less than that of the proximal and distal portions to receive the suture being threaded through. Use of the suture anchor disclosed in this patent, however, requires tying a suture knot. If the knot is not tied securely or if the knot is not made large enough, there is a risk that the knot will unravel or be pulled through the distal portion of the passageway.

Another prior art suture anchor is disclosed in U.S. Patent No. 5,370,662 and has an eyelet located at the proximal end of the anchor through which a suture can be passed.

In addition, a number of systems are known for the attachment of soft tissue to bone, such as the well-known Pushlok™ and Magnum™ suture anchors.

Problems can arise if the particular structure or arrangements of the suture anchor for securing the suture fails, thereby allowing the suture to become detached from the anchor. It is thus an aim of the present disclosure to provide a threaded suture anchoring device for lockingly accommodating one or more suture threads, which is simple in structure and easy to use.

SUMMARY OF THE INVENTION According to a first aspect of the disclosure, there is provided a suture anchoring device for lockingly accommodating one or more suture threads, the device comprising an elongate body, the body defining a cleat formation comprising an enlarged entrance opening for receiving the suture threads and a relatively narrower slit extending from the entrance opening in which the suture threads can be lockingly secured.

In an embodiment, the body defines a proximal end and a distal end that includes the cleat formation. In a first embodiment, the body comprises two complementary protrusions extending from the distal end of the body, the two protrusions being substantially parallel to each other and defining at least the entrance opening of the cleat formation. In this first embodiment, the entrance opening comprises a tapering wedge formation that tapers from the distal end of the body towards the slit.

In this first embodiment, the cleat formation extends for approximately one-third of the overall length of the suture anchoring device.

In this first embodiment, the angle of the tapering wedge is approximately between 5 and 30 degrees, with the entrance opening having a length of approximately between 1 mm and 6 mm, and with the slit having a length of approximately between 1 mm and 6 mm.

In this first embodiment, the elongate body defines at least one elongate groove on the outside of the body, the elongate groove extending between the proximate and distal ends of the suture anchoring device.

In a second embodiment, which is substantially similar to the first embodiment, a pair of jaws is fitted to, or extends from, the two protrusions at the distal end of the body, the jaws having curved ends that curve towards each other to define a gap therebetween.

In a third embodiment, the cleat formation is defined as an enclosed aperture within the body.

In all three embodiments, the body comprises an external formation, typically a helical formation, to facilitate the anchoring of the body into bone, the helical formation being broken to accommodate the at least one elongate groove on the outside of the body.

According to another aspect of the disclosure, there is provided a method of anchoring more than one suture thread to a suture anchor so as to secure soft tissue to a bone, the suture anchor being pre-loaded with a first suture thread, the suture anchor further including a cleat, the method comprising the steps of: passing a second suture thread through the soft tissue; placing the pre-loaded suture anchor in the bone by means of an inserter; guiding the second suture thread through the suture anchor by means of the first pre-loaded suture thread; in response to the soft tissue being in the required position, removing or sliding the inserter from the suture anchor so as to expose the cleat in the suture anchor; and engaging the second suture thread with the exposed cleat, thereby anchoring the second suture thread to the suture anchor.

According to a further aspect of the disclosure, there is provided a method of anchoring a suture thread to a suture anchor so as to secure soft tissue to a bone, the suture anchor including a cleat, the method comprising the steps of: passing the suture thread through the soft tissue; and looping a free end of the suture thread around the cleat so as to secure the suture thread to the suture anchor..

In an embodiment of the disclosure, the method further comprises the step of: placing the suture anchor with the secured suture thread into a pre-drilled hole in the bone.

According to a further aspect of the disclosure, there is provided a method of anchoring a suture thread to a suture anchor so as to secure soft tissue to a bone, the suture anchor being pre-loaded with a suture thread, the suture anchor further including a cleat, the method comprising the steps of: placing the pre-loaded suture anchor in the bone; and using one or more mayo needles to pass the suture thread through the soft tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a perspective view of a suture anchoring device according to a first aspect of the disclosure;

Figure 2 shows a perspective view and a side view of a suture anchoring device according to a second aspect of the disclosure;

Figure 3 shows a perspective view and a cut-away perspective view of a suture anchoring device according to a third aspect of the disclosure;

Figure 4 shows a graphical representation of a method of anchoring one or more suture threads, in accordance with the proposed functioning of the embodiment of the device of Figure 1 ; and Figure 5 shows a perspective view of a suture anchoring device according to a fourth aspect of the disclosure.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring to Figure 1 of the drawings, a suture anchoring device 10 for lockingly accommodating one or more suture threads (not shown for clarity, but as is well known in the art), is shown. The device 10 is typically made from a Nylon plastics material eg. PEEK (polyether ether ketone) or polyethylene.

The device 10 comprises an elongate body 12, the body 12 defining a groove in the form of a cleat formation 14. The cleat formation 14 in turn comprises an enlarged entrance opening 16 for receiving the suture threads and a relatively narrower slit 18 extending from the entrance opening 16, in which the suture threads can be lockingly secured.

In an embodiment, the body 12 defines a proximal end 20 and a distal end 22 that includes the cleat formation 14.

The body 12 may comprise two complementary semi-circular (in cross-section) protrusions 24, 26 that extend linearly from (so as to be aligned with) the distal end 22 of the body 12. The two protrusions 24, 26 run substantially parallel to each other, and define at least the enlarged entrance opening 16 of the cleat formation 14.

In one version, the entrance opening 16 comprises a tapering wedge formation 28 having planar side walls 30, 32 that taper from the distal end 22 of the body 12 towards the slit 18.

In this version, the cleat formation 14 extends for approximately one-third of the overall length of the suture anchoring device 10.

In a specific embodiment, the angle of the side walls 30, 32 of the tapering wedge 28 is approximately between 5 and 30 degrees, with the entrance opening 16 having a length of approximately between 1 mm and 6 mm, and with the slit 18 having a length of approximately between 1 mm and 6 mm. However, it is to be appreciated that these angles and lengths may vary according to the size of the sutures and the anchor.

The elongate body 12 defines a pair of opposite elongate grooves 34 (only one of which is shown in Figure 1) on the outside of the body 12, which may be used to accommodate the suture threads when in use. The elongate grooves 34 extending between the proximate and distal ends 20, 22 of the suture anchoring device 10.

The body 12 comprises an external formation, typically a helical formation 36, to facilitate the anchoring of the body 12 into bone. As clearly shown, the helical formation 26 is broken longitudinally to accommodate the at least one elongate groove 34 on the outside of the body 12.

In use, there are various ways of attaching soft tissue to bone, with one of the features of the device of the present disclosure being to provide the surgeon with a range of options. The device 10 will come sterile packed and already preloaded with suture thread and attached to an inserter handle. The following are some of the envisaged techniques:

1. The anchor device may be inserted into bone and another suture, already placed through adjacent soft tissue, may then be shuttled through the anchor, typically by sliding along the elongate grooves 34 of the anchor and tracking the preloaded suture. Once the soft tissue is in the required position, the inserter handle may then be removed, thereby exposing the cleat, to cause the suture to be engaged in the cleat and therefore locked in place.

2. The preloaded suture may be removed and the distal end opening in the anchor device may be hooked over a looped suture that has been previously passed through the soft tissue. In this case, the anchor and engaged suture may be punched into a predrilled hole in the bone. This procedure will be mostly used for a medial row placed anchor.

3. The anchor with the preloaded suture may be inserted into the bone and Mayo surgical needles may be used to pass the suture ends through the soft tissue. In this procedure, knot tying will be required.

Turning now to Figure 2, a second embodiment of a suture anchoring device 50 is shown. The device 50 is substantially similar to the device 10 shown in Figure 1 , and thus similar components will have the same reference numeral, save for the addition of a single apostrophe ('). Similar components will accordingly not be described again. In this second embodiment, a pair of jaws 52, 54 extends from the two protrusions 24', 26' at the distal end 22' of the body 12'. The jaws 52, 54 terminate in curved ends 56, 58 that curve towards each other to define a gap 60 therebetween. The jaws 52, 54 serve to prevent the suture threads from escaping from the device 50.

In a specific embodiment, the angle of the side walls 30', 32' of the tapering wedge 28' is approximately between 5 and 30 degrees, with the entrance opening 16' having a length of approximately between 1 mm and 6 mm, and with the slit 18' having a length of approximately between 1 mm and 6 mm.

Turning now to Figure 3, a third embodiment of a suture anchoring device 70 is shown. The device 70 is substantially similar to the device 10 shown in Figure 1 , and thus similar components will have the same reference numeral, save for the addition of a double apostrophe ("). Similar components will accordingly not be described again.

In this third embodiment, the cleat formation 14" is defined as an enclosed aperture within the body 12". In other words, the cleat formation 14" is surrounded by the body 12" and extends the entire width of the body 12". In particular, the cleat formation 14" is bell-shaped and comprises an enlarged entrance opening 16" for receiving the suture threads and a relatively narrower slit 18", in which the suture threads can be lockingly secured.

With reference to Figure 4, a method of anchoring one or more suture threads is generally indicated by reference numeral 100.

According to a first step of the method 100, a suture anchoring device having a first, pre-loaded suture thread is placed in a bone by means of an inserter device, at block 102. A second suture thread is passed through the soft tissue sought to be secured to the bone, at block 104.

At block 106, the second suture thread is then shuttled through the pre-loaded suture anchor with the help of the first suture thread. Once the soft tissue is in the required position, at block 108, the inserter device is removed from the anchor member. In particular, through removal of the inserter device two linear protrusions in the anchor member is exposed. Subsequently, the second suture thread can then be secured to the suture anchor through engagement with the groove defined between the two exposed linear protrusions, at block 110. In one version, the method 100 may comprise the step of exposing the tapered indentation (i.e. the cleat formation) of the anchor.

Finally, turning now to Figure 5, a fourth embodiment of a suture anchoring device 120 is shown. The device 120 is substantially similar to the device 10 shown in Figure 1 , and thus similar components will have the same reference numeral, save for the addition of a triple apostrophe ("'). Similar components will accordingly not be described again.

In this fourth embodiment, a pair of jaws 122, 124 extends from the two protrusions 24"', 26"' at the distal end 22"' of the body 12"'. The jaws 122, 124 terminate in curved ends 126, 128 that curve towards each other to define a gap 130 therebetween. The jaws 122, 124 serve to prevent the suture threads from escaping from the device 120. In the specific embodiment, the angle of the side walls 30"', 32"' of the of the tapering wedge 28"' is approximately between 5 and 30 degrees, with the entrance opening 16"' having a length of approximately between 1 mm and 6 mm, and with the slit 18"' having a length of approximately between 1 mm and 6 mm.

Claims

A suture anchoring device for lockingly accommodating one or more suture threads, the device comprising an elongate body, the body defining a cleat formation comprising an enlarged entrance opening for receiving the suture threads and a relatively narrower slit extending from the entrance opening in which the suture threads can be lockingly secured.

The suture anchoring device of claim 1 , wherein the body defines a proximal end and a distal end that includes the cleat formation.

The suture anchoring device of claim 2, wherein the body comprises two complementary protrusions extending from the distal end of the body, the two protrusions being substantially parallel to each other and defining at least the entrance opening of the cleat formation.

The suture anchoring device of claim 3, wherein the entrance opening comprises a tapering wedge formation that tapers from the distal end of the body towards the slit.

The suture anchoring device of either claim 3 or claim 4, wherein a pair of jaws is fitted to, or extends from, the two protrusions at the distal end of the body, the jaws having curved ends that curve towards each other to define a gap therebetween.

The suture anchoring device of claim 2, wherein the cleat formation defined as an enclosed aperture within the body.

The suture anchoring device of any one of claims 2 to 6, wherein the elongate body defines at least one elongate groove on the outside of the body, the elongate groove extending between the proximate and distal ends of the suture anchoring device. The suture anchoring device of claim 7, wherein the body comprises an external formation, typically a helical formation, to facilitate the anchoring of the body into bone, the formation being broken to accommodate the at least one elongate groove on the outside of the body.

The suture anchoring device of any one of the preceding claims, wherein the cleat formation extends for approximately one-third of the overall length of the suture anchoring device.