WO2016151334A1

WO2016151334A1 - Suture anchor delivery tool

Info

Publication number: WO2016151334A1
Application number: PCT/GB2016/050847
Authority: WO
Inventors: David Foster; Robert Bruns
Original assignee: Summit Medical Ltd
Current assignee: Summit Medical Ltd
Priority date: 2015-03-24
Filing date: 2016-03-24
Publication date: 2016-09-29
Anticipated expiration: 2017-09-24
Also published as: GB201504936D0; GB2537592A

Abstract

A suture anchor delivery device comprising a handle configured to be attached to a shaft for engaging a suture anchor, wherein the handle comprises bobbin means around which a suture, extending, in use, from the anchor attached to the shaft, is wound to secure and hold, under tension, the suture; the device further including, in the handle, locking means for locking the bobbing against rotation and release means for releasing the bobbin to allow rotation so as to allow the suture to unwind from around the bobbin.

Description

Suture Anchor Delivery Tool The present invention is concerned with a tool or device for delivering a suture anchor to a bone site.

Suture anchors are used in various situations for anchoring surgical suture to bone. For example, if soft tissue tears away from bone, reattachment becomes necessary. One way of treating this is to provide a suture anchor that is anchored into the bone site and provides a secure attachment for suture that is then threaded through the tissue, or other material to be reattached to the bone site.

Various types of suture anchors are known, and the most commonly used suture anchors have an externa! thread to allow the anchor to be screwed into and secured in the bone. Alternatively, the anchor may be provided with an interference fit similar to a rawplug or may be provided with other anchoring mechanisms such as tines, protrusions or the like. Various materials are suitable for bone anchors, including metal, PEEK or a biodegradable materia! which dissolves in the body over time.

Most commonly used anchors comprise the anchor itself provided with the external thread or other securing means, and preferably provided with a tapered or pointed end to simplify insertion into the bone. The anchor is also provided with some sort of eyelet or securing means for attachment of the suture to the anchor. The eyelet can be, for example, a hole or a loop in the anchor through which the suture passes or to which the suture is attached.

Various suture materials are known and common sutures can be made of non- absorbable material or absorbable material. In use, generally, an insertion tool is used to drive the anchor into the bone at the insertion site, either by screwing or applying some other force, and the anchor engages with and is secured in place in the bone by means of the thread or other securing means. The suture may be pre- attached to the anchor on insertion or may be threaded through the eyelet once the anchor has been fixed in the bone. The open ends of the suture are then sewn or otherwise attached to the tissue, usually by means of a needle, thus fixing the tendon or tissue to the bone.

There are two main types of procedure for securing the tissue or tendon to the bone using the anchor/suture arrangement in an open surgery approach, the suture is provided with pre-attached needles. The needles are curved and are used to stitch through the soft tissue, e.g. the rotator cuff, that needs reattaching to the bone. This is done once the anchor and suture are inserted into and anchored within the bone. Hand stitching is possible due to the open wound site:

An alternative to open surgery is arthroscopic or keyhole surgery. Here, the sutures are not provided with pre-attached needles. Instead, a secondary device is used to pass the suture through the tissue or tendon, e.g. the rotator cuff. Again, this is done after the anchor and suture have been inserted into and secured in the bone.

As mentioned above, delivery devices are available to deliver and insert the anchor to the bone. Conventional delivery devices comprise an elongate shaft attached to a handie, similar, in appearance, to a conventional screwdriver. The distal end of the shaft engages with the anchor. The handie is attached to the other end of the shaft and force is applied (either axialiy or a rotational force) to push or screw the anchor into the bone. For anchors with pre-attached suture, delivery devices are available which retain the suture to extend away from the implant site, along the shaft, to keep the suture out of the way, whilst the anchor is being inserted into the bone. The free ends of the suture can be attached to or inside the handle of the delivery device so as to keep the suture under tension, which prevents the suture becoming tangled or snagged and also secures the anchor under tension to the distal end of the delivery device shaft. Once the anchor is located, the sutures can be released to attach the tissue/tendons etc. Most existing devices comprise an elongate metailic shaft attached to a plastic handle. The delivery device is generally a single-use, disposable device, although devices with disposable shafts and reusable handles are also available. Delivery devices are available for delivering anchors with pre-attached sutures either with or without pre-attached needles.

As mentioned above, for open surgery, the anchor and suture usually come with pre-attached curved needles, Delivery devices are available that allow the anchor to be received at the distal end of the shaft, with the sutures extending along the outside of the shaft to the handle, where the sutures and, if provided, the pre- attached needles are secured whilst the anchor is inserted, and then released, for use (e.g. Fig. 1). Where the needles are not pre-attached, for example for arthroscopic surgery, the sutures can be retained along the inside of the hollow metal shaft of a delivery device, which retains the sutures better, prior to release (e.g. Fig. 2). The use of a hollow shaft of a delivery device, within which the sutures can pass, avoids the problem of 'tenting', that can arise with delivery devices where the sutures extend along the outside of the shaft to the handle, as discussed below.

Generally speaking, the handle of the delivery device has a greater diameter than that of the metal shaft, as this is the most practical and user-friendly construction. This means, however, that the sutures, extending along the outside of the shaft, start from a narrow point where the shaft engages with the anchor, and then extend radially outwards as they engage with and are secured to or within the handle. This gives rise to a region towards the joint between the handle and the metal shaft where the sutures are spaced from the shaft, and this is known as tenting'. This can mean that the sutures are in the way during anchor insertion, as they can catch on surrounding wound site soft tissue.

For handles with pre-attached needles, the needles also need to be securely stowed, to avoid, for example, tearing the gloves of the surgeon or causing injury,: ln one known delivery device, the ends of the sutures and the pre-attached needles are securely stowed within the body of the handle. To release the suture and needles, after the anchor has been implanted, the handie is opened, by means of a slidable lid, and the suture and needles can then be removed and released.

A disadvantage of such systems is that the surgeon needs two hands to actually open the lid which can be difficult and time consuming during surgery.

An alternative delivery device has been designed having a handle construction for securing the sutures and stowing the pre-attached needles more securely and which is configured to allow an easier release of the sutures and the needles. The delivery device comes pre-loaded with the anchor, sutures and needles. The anchor is mounted to the distal end of the shaft and the sutures extend along the shaft into the handle, running externally to the shaft but within recessed slots. A transitional portion between the shaft and the handle, of an intermediate diameter, ensures that the sutures are kept close to the body of the shaft to avoid tenting. The sutures are gripped and compressed to the handie and are locked in place which secures the suture and also holds the anchor securely to the distal end of the shaft. After the anchor has been inserted, the needles and suture are released by rotation of the handle which allows single-handed release. The needles drop out of cavities inside the handie, on rotation.

Whilst this handle allows for secure stowing of the sutures and needles during implantation of the anchor and allows for single-handed release of the needles, one problem is that the needles merely drop out of the handle once the cavity is opened which could be considered dangerous.

The aim of the present invention is to provide a suture anchor delivery device that securely holds the anchor and suture and, if provided, needles, in place whilst the anchor is being implanted into the bone and which enables simple and safe release of the suture and needles after implantation. in accordance with one aspect, the present invention provides a suture anchor delivery device comprising a handie configured to be attached to a shaft for engaging a suture anchor, wherein the handie comprises bobbin means around which a suture, extending, in use, from the anchor attached to the shaft, is wound to secure and hold, under tension, the suture; the device further including, in the handle, locking means for locking the bobbing against rotation and release means for releasing the bobbin to allow rotation so as to allow the suture to unwind from around the bobbin.

In accordance with a second aspect, the present invention provides a suture anchor delivery device comprising an elongate shaft having, at one end, means for receiving a suture anchor to which a length of suture is attached; and a handie attached to the other end of the shaft, wherein the handle comprises bobbin means around which a suture, extending, in use, from the anchor attached to the shaft, is wound to secure and hold, under tension, the suture; the device further including, in the handie, locking means for locking the bobbing against rotation and release means for releasing the bobbin to allow rotation so as to allow the suture to unwind from around the bobbin, in a third aspect of the invention, the present invention provides a kit comprising a suture anchor delivery device as described in relation to the second aspect, as well as an anchor mounted to the first end of the shaft, and a length of suture attached to the anchor and extending along the length of the shaft into the handle, the free ends of the suture being wound around the bobbin means and held, under tension, by means of the locking means locking the bobbin.

In some embodiments, the shaft is a hollow body and the suture extends along the shaft within the hollow body.

In some embodiments, the handle includes means for retaining one or more curved needles attached to the suture. In the most preferred embodiment, the retaining means are provided within the bobbin means.

Preferred embodiments of the invention will now be described, by way of example only, with reference to the drawings.

Fig. 1 is a side schematic view of a known delivery device;

Fig. 2 is a sectional view of an alternative known device; Fig. 3 is a perspective view of a delivery tool according to an embodiment of the invention;

Fig. 4 is a perspective view of a delivery tool according to an embodiment of the invention;

Fig. 5 is a side sectional view of an embodiment of the invention with the bobbin Eocked;

Fig. 6 is a view as in Fig. 5 but with the bobbin released;

Fig. 7 is a detailed section of the bobbin of one embodiment;

Fig. 8 is a side sectional view of an alternative embodiment;

Fig. 9 is a detaiied section of the bobbin of an alternative embodiment;

Fig. 10 is a detailed perspective view of the handle of one embodiment.

Fig. 3 is a perspective view of a delivery device according to one aspect of the invention. The device comprises a handie 1 which, in preferred embodiments, is made of plastic or a similar light material that can be easily held in the hand of the user. The handie can be disposable or re-usabie.

The distal end of the handie is configured to receive an elongate shaft 2. This shaft may be made of metal or some other suitable material for insertion into the body. The shaft is preferably disposable but could, in theory, be re-usable provided the necessary standards of hygiene are retained.

The distal end 4 of the shaft, furthest from the handle, is arranged to receive the anchor to be positioned in the bone site.

When the anchor 5 is mounted on the distal end of the shaft, the suture 6 attached to the anchor is extended along the length of the shaft and is secured in the handle. In some embodiments the suture length can be provided within the metal shaft, in which case the shaft is a hollow body, as shown in Fig. 8 and described further below.

one hand but, of course, the actual shape of the handie can be any design and shape and the shape of the handle is not part of the invention. In the embodiment shown, the end of the handle to which the shaft is attached has two openings to receive the free ends of the sutures and these extend into the body of the handle. In this embodiment, a handle lid 7, which is preferably removable, is provided and a button 8, movable between two positions, is mounted on the handle. The example of the button is for locking and releasing the bobbins, as described below. Any button or other mechanism that can be operated by the user, to cause the locking and releasing, can be used.

Fig. 4 shows the delivery device of Fig. 3, with the handle lid 7 removed.

Inside the handle is provided the bobbin means 9 for receiving and securing the free ends of the suture 6. In the embodiment shown, two bobbins are provided, one for each free end of the length of suture. It is conceivably, however, that a single bobbin could be used.

While the delivery device is provided pre-loaded with the anchor and sutures, the anchor is mounted to the distal end of the shaft and the sutures are pulled into the handle and wound tightly around the bobbins and then secured in place by locking the bobbins.

For delivery devices where the suture ends are provided with a curved needle, the handle is configured to stow the needles in the pre-loaded configuration, as will be described further below. The handle is provided with means for locking the bobbin agsinst rotation, prevent unwinding of the suture and means for releasing the bobbin to allow rotation to allow unwinding of the suture for use. Preferred embodiments are shown in Figs. 5 and 6. In the preferred embodiment, the bobbin comprises a number of teeth 10 arranged around the bobbin. The handle is provided with a movable lug 11 that can be moved, for example by means of the button, or other slider or configuration to engage with the teeth, in the locked position, thus preventing the bobbin from rotating. To release the bobbin, the button or other release means moves the lug 11 out of engagement with the teeth as shown in Fig. 6, thus allowing the bobbin to rotate and to release the suture and, if provided, the needles. Otter means can be used to lock and release the bobbin, e.g. by means of friction or other forms of engagement. Fig, 7 shows a detail section of the bobbin in an embodiment having means for stowing pre-attached needies 12. The bobbin is provided with a slot 13 within which the needie(s) fits. As the bobbin rotates to release, the suture will unwind and draw the needle out of the slot. In some embodiments, as mentioned above, but not those having pre-attached needies, the shaft may be a holiow shaft and the sutures can be retained within and along the length of the hollow shaft as shown in Fig. 8.

Other aspects of the attachment, within the handle, are as described above.

As shown in Fig. 9, in one embodiment, a separating tab, for example a small triangular tab 14, can be provided at the entrance to the bobbin, along the sides of which the sutures are fed and are locked to either side of the tab as can be seen in Fig. 9. Other means can be provided, of course, for securing the sutures within the bobbin.

In embodiments where the suture extends along the outside of the tab, means may also be provided to avoid the problems of tenting described above. The handle may include, preferably close to the point where the shaft meets the handie, a retaining means 15 for retaining the suture close to the shaft. In the embodiment shown in Fig. 10, this may be in the form of a L-shaped peg 1:5 that provides a retaining force on the suture.

The handle arrangement of the present invention ensures that the bobbins and, therefore, the sutures and, where available, needies, unwind in a controlled manner, and that the release of the sutures can be performed easily, by the surgeon, with one hand, simply by sliding the button or other release mechanism on the handle and pulling the handle in a direction away from the patient.

Claims

1. A suture anchor delivery device comprising a handle configured to be attached to a shaft for engaging a suture anchor, wherein the handle comprises bobbin means around which a suture, extending, in use, from the anchor attached to the shaft, is wound to secure and hold, under tension, the suture; the device further including, in the handle, locking means for locking the bobbing against rotation and release means for releasing the bobbin to allow rotation so as to allow the suture to unwind from around the bobbin.

2. A suture anchor delivery device comprising an elongate shaft having, at one end, means for receiving a suture anchor to which a length of suture is attached; and a handle attached to the other end of the shaft, wherein the handle comprises bobbin means around which a suture, extending, in use, from the anchor attached to the shaft, is wound to secure and hold, under tension, the suture; the device further including, in the handle, locking means for locking the bobbing against rotation and release means for releasing the bobbin to allow rotation so as to allow the suture to unwind from around the bobbin.

3. A kit comprising a suture anchor delivery device as described in relation to the second aspect, as well as an anchor mounted to the first end of the shaft, and a length of suture attached to the anchor and extending along the length of the shaft into the handle, the free ends of the suture being wound around the bobbin means and held, under tension, by means of the locking means Socking the bobbin.

4. The device of claim 1 or 2 or the kit of claim 3, wherein the shaft is a hollow body and the suture extends along the shaft within the hollow body.

5. The device of claim 1 , 2 or 4 or the kit of claim 3 or 4, wherein the handle includes means for retaining one or more curved needles attached to the suture.

6. The device or kit of claim 5, wherein the retaining means areprovided within the bobbin means.