Patent Description:
The present invention relates to medical devices and procedures. More particularly, the present invention relates to devices for securing soft tissue to a rigid material such as bone.

There are several medical procedures where a surgeon needs to attach soft tissue such as tendons or other soft connective tissue to bone. One common example is a biceps tenodesis, a surgical procedure usually performed for the treatment of biceps tendonitis of the shoulder. A biceps tenodesis may be performed as an isolated procedure, but more often is part of a larger shoulder surgery such as a rotator cuff repair.

The biceps tendon connects the biceps muscle to the bone. The tendon passes from the muscle to the shoulder joint. Patients with biceps tendon problems may have a detachment of the biceps tendon from the radial tuberosity, for example, or they may have inflammation and irritation of the biceps tendon itself. Biceps tendon problems can also occur in conjunction with a rotator cuff tear.

A biceps tenodesis is a procedure that cuts the normal attachment of the biceps tendon on the shoulder socket and reattaches the tendon to the bone of the humerus (arm bone). By performing a biceps tenodesis, the pressure of the biceps attachment is taken off the cartilage rim of the shoulder socket (the labrum), and a portion of the biceps tendon can be surgically removed. Essentially a biceps tenodesis moves the attachment of the biceps tendon to a position that is out of the way of the shoulder joint.

To perform a biceps tenodesis repair, typically a surgical procedure is used and requires the multiple steps of externalizing the tendon, whip stitching it, threading suture through a tenodesis screw, drilling the necessary bone hole and anchor insertion via screwing it in. This is a difficult procedure arthroscopically. Systems recently brought to market still require multiple steps and tools.

Another common example is a anterior cruciate ligament repair, a surgical procedure usually performed for the treatment of the ligament of the knee. An ACL repair may be performed as an isolated procedure, but is often part of multiple-repair surgery.

Document <CIT> discloses a knotless suture anchor for securing soft tissue to bone, comprising an hollow inner member, slidable within an hollow outer member, and a suture extending along a path between annular surfaces of members, where the suture is in locked/ unlocked position.

In one embodiment, a tissue capture anchor for attaching tissue to bone is disclosed, the anchor comprising an anchor body comprising at least two expandable tines, and a spreader configured to fit within the anchor body. The spreader comprises a pointed tip configured to spear tissue and an angled portion configured to force the expandable tines to deploy as the spreader is advanced through the anchor body. In some embodiments, the anchor body comprises a central hold adapted to receive the proximal end of the spreader. In yet another embodiment, the outside surface of the spreader comprises a lateral protrusion and the central hole of the anchor body comprises indentations adapted to engage the lateral protrusion for inhibiting movement of the proximal end of the spreader relative to the central hole. In another embodiment, the inside surface of the central hole in the anchor body comprises a groove and the proximal end of the spreader comprises a ridge adapted to fixedly snap within the anchor body's groove. Another embodiment of the anchor body is comprised of polyether-ether-ketone (PEEK). In some embodiments, the the outside surface of each tine comprises at least two teeth. In other embodiments, an outside surface of the tines comprise ridges or teeth which are configured to secure the anchor body within bone.

In one method (not claimed), a tissue capture anchor for attaching tissue to bone, the anchor is disclosed. The anchor includes an anchor body including at least two expandable tines; and a spreader configured to fit within the anchor body, the spreader including an angled portion configured to force the expandable tines outward as the spreader is moved relative to the anchor body. In one embodiment, the tissue capture anchor also included a distal tip comprising a suture loop extending therefrom configured to receive tissue. In one embodiment, the flat tip comprises two holes through which two limbs of the suture loop extend. In one embodiment, the anchor body further comprises a central hole adapted to receive a proximal end of the spreader, the central hole including indentations adapted to engage the lateral protrusion to thereby inhibit movement of the proximal end of the spreader relative to the central hole and also wherein the inside surface of the central hole in the anchor body comprises a groove and the proximal end of the spreader comprises a ridge adapted to fixedly snap within the anchor body's groove. In one embodiment, the anchor is made of polyether-ether-ketone (PEEK). In one embodiment, the anchor comprises at least two tines comprising at least two teeth per tine which are configured to secure the anchor body within bone.

In another embodiment, a tissue capture anchor and inserter combination is disclosed, where the combination comprises an anchor comprising a handle, an outer tube coupled to the handle, an inner rod or tube positioned within the outer tube and coupled to the spreader, an actuator shaft positioned within the handle and coupled to the inner rod, and a deployment knob coupled to the handle and the actuator shaft and configured to move the actuator shaft relative to the handle and the inner rod or tube relative to the outer tube wherein the inserter tool is configured to draw the spreader into the bone anchor to fully deploy the tissue capture anchor and secure tissue to the bone.

In another embodiment a tissue capture anchor and inserter combination is disclosed, the anchor comprising an anchor as described above, a handle; an outer tube coupled to the handle, an inner tube or rod positioned within the outer tube and coupled to the spreader, an actuator shaft positioned within the handle and coupled to the inner tube or rod; and a deployment knob coupled to the handle and the actuator shaft and configured to move the actuator shaft relative to the handle and the inner tube relative to the outer tube and wherein the inserter tool is configured to draw the spreader into the anchor body to expand the tines and secure tissue to the bone. In one embodiment, the captured tissue is folded around the anchor longitudinally. In one embodiment, the anchor further comprises a curved distal end comprising a suture loop, an angled portion, interior to the spreader, configured to force the expandable tines outward as the spreader is moved relative to the anchor body, and wherein the suture loop is configured to receive tissue. In one embodiment, the curved end comprises two holes configured to receive suture and the spreader comprises a central hole adapted to receive the proximal end of anchor body.

In yet another embodiment, a method (not claimed) of attaching soft tissue to bone is disclosed, the method comprising spearing the soft tissue with a bone anchor and inserting the anchor and speared tissue into the bone; wherein the anchor comprises expandable tines which are configured with teeth to engage the bone and deploying the anchor to secure it and the soft tissue in the bone. In another embodiment, the method further comprises making a clearance hole for the tissue capture anchor. In another embodiment, the clearance hole is drilled in the bicipital groove. In yet another embodiment, the clearance hole is sized to receive an anchor. In another embodiment, method further comprises making a bone hole for the tissue capture anchor. In one embodiment, he bone hole is made using an awl. In yet another embodiment, the bone hole is made with a drill. In another embodiment, the bone hole is made with the tip of the spreader.

In one embodiment, a tissue capture anchor for attaching tissue to bone is disclosed, the anchor comprising an anchor body comprising at least two expandable tines, and a spreader configured to fit within the anchor body. The spreader comprises a flat tip with apertures for sutures to form a loop and capture tissue and an angled portion configured to force the expandable tines to deploy as the spreader is advanced through the anchor body. In some embodiments, the anchor body comprises a central hold adapted to receive the proximal end of the spreader. In yet another embodiment, the outside surface of the spreader comprises a lateral protrusion and the central hole of the anchor body comprises indentations adapted to engage the lateral protrusion for inhibiting movement of the proximal end of the spreader relative to the central hole. In another embodiment, the inside surface of the central hole in the anchor body comprises a groove and the proximal end of the spreader comprises a ridge adapted to fixedly snap within the anchor body's groove. Another embodiment of the anchor body is comprised of polyether-ether-ketone (PEEK). In some embodiments, the the outside surface of each tine comprises at least two teeth. In other embodiments, an outside surface of the tines comprise ridges or teeth which are configured to secure the anchor body within bone.

In some embodiments, the tissue is secured without the use of sutures or knots.

In one embodiment, the method is conducted arthroscopically. In another embodiment, the method is conducted percutaneously. In yet another embodiment, the method is conducted in open surgery.

In one embodiment, spearing the tissue and inserting the anchor comprises moving the anchor into the bone so as to capture the soft tissue into the bone. In another embodiment, the soft tissue is secured within the bone by forcing the anchor within the bone after the tissue has been speared by the anchor.

In one embodiment, capturing the tissue and inserting the anchor comprises moving the anchor into the bone so as to capture the soft tissue into the bone. In another embodiment, the soft tissue is secured within the bone by forcing the anchor within the bone after the tissue has been captured and secured by the anchor.

The present invention is particularly suited for use in arthroscopic procedures, including but not limited to biceps tenodesis. More broadly, it can be used in any procedure in which it is desired to capture tissue and secure to bone without the use of sutures and without tying of knots, including not only arthroscopic procedures, but also open surgery.

In various embodiments, soft tissue may be attached to bone utilizing one or more tissue capture anchors. In the following non-limiting examples elements 100a and 100b illustrate two embodiments of a bone anchor, and likewise elements 300a and 300b illustrate a spreader element of the bone anchors. In the following paragraphs, where element <NUM> is used, it is assumed that elements 100a and 100b are contemplated. Where element <NUM> is used, it is assumed that elements 300a and 300b are contemplated. The elements 300a and 300b or their corresponding anchor embodiments 100a and 100b are referenced specifically when pertinent.

In one non-limiting example illustrated in <FIG>, a pointed tip is used to capture tissue. In another non-limiting example illustrated in <FIG>, suture loop is used to capture tissue. <FIG> and <FIG> depict a side view of a tissue capture anchor <NUM> comprising an anchor body <NUM> and a spreader <NUM>. <FIG> additionally comprises a suture loop <NUM>. The anchor body <NUM> is comprised of tines <NUM> and teeth <NUM>. The tines <NUM> expand from the distal end <NUM> of the anchor body <NUM> when the spreader <NUM> is engaged with the anchor body <NUM>. The proximal end of the spreader <NUM> is configured to fit into the distal end <NUM> of the anchor body <NUM>. In <FIG> and <FIG>, the tissue capture anchor <NUM> is in the undeployed, or unexpanded position.

<FIG> and <FIG> show a perspective view of the unexpanded tissue capture anchor <NUM>. In this embodiment, the spreader <NUM> is slightly inserted in the central hole <NUM> at the distal end of the anchor body <NUM>.

<FIG> and <FIG> show a side view of the tissue capture anchor <NUM> in the deployed or expanded position. In the deployed or expanded position, the spreader <NUM> has been drawn up into the anchor body <NUM> causing the tines <NUM> to expand from the distal end of the anchor body <NUM>. When deployed, the teeth <NUM> engage with the bone surface trapping tissue between the bone and the bone anchor <NUM>.

The inside surface of the anchor body <NUM> may comprise a grooved surface <NUM> to engage with the ridge <NUM> of the spreader <NUM> to lock the spreader <NUM> into place when the anchor body <NUM> is fully deployed. The grooved surface <NUM> is oriented such that the distal end of the spreader <NUM> can be easily moved in the proximal direction in central hole <NUM> of the anchor body <NUM> with the ridge <NUM> snapping into the groove <NUM> as the distal end is moved proximally. However, when the ridge <NUM> is snapped into groove <NUM>, proximal movement of distal end is inhibited. In some embodiments, the groove <NUM> can exist at different locations of the surface of the central hole or else even along substantially the entire surface of the central hole <NUM>. In some embodiments the anchor body <NUM> may be coupled to the spreader <NUM> in several positions. In other words, in one embodiment the spreader <NUM> need not be inserted into the anchor body <NUM> as far as it will go for it to be secured to the anchor body <NUM>.

Although a grooved surface is illustrated, it will be appreciated that other shapes are also contemplated, including multiple concentric grooves, a series of protruding ridges, or any other suitable structure that permits a spreader <NUM> to be securely locked within the central hole of the anchor body <NUM>.

With reference to <FIG> and <FIG>, which are each a perspective view of the top and side of anchor body <NUM> engaged with the spreader <NUM>, the top (proximal end) comprises a hole <NUM> in the center for receiving the spreader <NUM>. In some embodiments, the top surface <NUM> of the anchor body <NUM> may be textured such as with a scallop shape or grooves so as to inhibit movement of an insertion tool against the surface of the anchor body.

During deployment, the spreader <NUM> is drawn into the anchor body <NUM> causing the tines <NUM> to expand from the distal end of the anchor body <NUM>. Also during deployment, the spreader <NUM> is drawn into the anchor body <NUM> until the ridge <NUM> of the spreader <NUM> passes a groove <NUM> in the anchor body <NUM>. When the spreader passes this point, the ridge <NUM> and groove <NUM> engage or click and the spreader <NUM> is locked into place and the anchor body <NUM> cannot undeploy or reverse and the spreader <NUM> cannot reverse direction.

<FIG> and <FIG> each show a distal end view of the tissue capture anchor <NUM>. In this view the anchor body <NUM> is fully deployed. The spreader <NUM> is securedly fixed into the anchor body <NUM> and the ridge <NUM> and groove <NUM> of the anchor body <NUM> will keep the spreader <NUM> from being uninserted or reversed from the anchor body <NUM>. The tines <NUM> are fully expanded. Since the teeth <NUM> are facing the opposite direction from the view of <FIG> and <FIG>, only their edges are visible along the edges of the tines <NUM>.

<FIG> depict an embodiment of an undeployed anchor body <NUM>. <FIG> depicts a side view of the anchor body <NUM>. <FIG> depicts a perspective view of an embodiment of the anchor body <NUM>. <FIG> depicts a view from the proximal end of the anchor body <NUM>, and <FIG> depicts a perspective view from the distal end of the anchor body <NUM>. The proximal end <NUM> of the undeployed anchor body <NUM> is generally cylindrical in shape with a diameter larger than distal end <NUM>. With reference to <FIG>, a hole <NUM> may advantageously be provided in the center of proximal end <NUM>. With reference to <FIG>, the bottom of distal end <NUM> also contains a hole <NUM>. Hole <NUM> comprises a central opening that extends through the anchor body <NUM>. In some embodiments the anchor body <NUM> comprises a groove <NUM> in its inner surface, as shown in <FIG>. Thus, the inner surface of the anchor body <NUM> is not flat. In some embodiments, some or all of these surfaces may be textured such as with a scallop shape or grooves so as to inhibit movement of spreader <NUM> once it is withdrawn into the anchor body. In some embodiments, texturing in the inner surfaces of anchor body <NUM> matches texturing in the outer surfaces of the spreader <NUM>. It will be appreciated that the illustrated embodiments represent only one possibility; thus, other shapes for the surface of proximal end <NUM> may also be used.

The distal end <NUM> of the anchor body <NUM> is configured to receive the spreader <NUM>. Hole <NUM> in anchor body <NUM> is an opening into a central ("axial") bore into and through the anchor body <NUM>. The sides of the opening preferably include a groove for engaging with the spreader <NUM>. It will be appreciated that other methods (not claimed) of securing the spreader <NUM> within the anchor body <NUM> may be used, such as a frictional fit or threading.

The anchor body <NUM> is comprised of tines <NUM> which spread outwardly when engaged with the spreader <NUM>. The tines <NUM> engage with the bone fixedly securing the anchor body <NUM> in the bone. The tines comprise a number of teeth <NUM> which further engage with the tissue and bone in the deployed tissue capture anchor <NUM>. The number of tines <NUM> and teeth <NUM> can vary. In one embodiment, there are four tines <NUM> with five teeth <NUM> per tine <NUM>. The proximal end <NUM> of the anchor body <NUM> is configured to receive an inserter component, which is inserted through the hole <NUM> in the center of the anchor body <NUM> and is coupled with a spreader <NUM>.

The distal end <NUM> of the anchor body <NUM> may advantageously be tapered to facilitate insertion of the anchor body <NUM> into bone. The anchor body <NUM> has at its widest point, a diameter not larger than the widest point of the spreader <NUM>.

<FIG> depict an alternate embodiment of an anchor body <NUM>. In this embodiment, the anchor body also comprises webbed portions <NUM> across the distal ends of the tines <NUM>. These webs <NUM> are easily broken when the spreader <NUM> is engaged with the anchor body <NUM>. The webs <NUM> protect against premature deployment of the anchor upon insertion into the bone by keeping the tines <NUM> intact until they are expanded via the spreader <NUM>.

<FIG> depict one embodiment of a spreader 300a with a pointed tip. <FIG> depict another embodiment of a spreader 300b with a flat face and comprising a suture loop.

<FIG> shows a side view of an embodiment of the spreader 300a. <FIG> shows a perspective view of the spreader 300a. The spreader 300a comprises a generally cone-shaped <NUM> pointed distal end <NUM> and a proximal end <NUM> with a means for receiving an insertion tool <NUM>, a central body <NUM>, a ridge <NUM> and a narrow section <NUM>. The distal end <NUM> further comprises a tip <NUM> for engaging the tissue. The proximal end <NUM> is configured for coupling with an inserter. For instance, in this embodiment, the proximal end <NUM> of the spreader 300a comprises a hole <NUM> that receives the inserter tool for coupling.

The spreader 300a further comprises central body <NUM> which gradually widens from the proximal end and forms a ridge <NUM> before it narrows again <NUM> and joins with proximal end of the tip <NUM>. The distal end <NUM> is generally cone shaped <NUM>, meaning that it gradually widens in a conical shape until it fits with the central body <NUM> at the site of the ridge <NUM>. In some embodiments, the ridge <NUM> may be slightly undercut <NUM> which may result in a stronger lock in the bone when then the anchor is fully deployed.

The tip <NUM> of the spreader 300a can be sharp and configured to spear or stab tissue and drag it into a bone hole before the tissue capture anchor <NUM> is deployed.

The spreader 300a is configured to be drawn into the distal end of the anchor body <NUM> via an insertion tool. As the tissue capture anchor <NUM> is deployed, the spreader <NUM> is further advanced into the anchor body <NUM>, spreading the tines <NUM> of the anchor body <NUM> until the ridge <NUM> of the spreader 300a engages the groove <NUM> in the inside of the anchor body <NUM> at which point it locks into place. In one embodiment, the ridge <NUM> is undercut <NUM> providing even more security for reversing.

In another embodiment, the spreader 300a further comprises a hole <NUM> that extends longitudinally through the spreader 300a to the distal end. In this embodiment, the tip of the spreader <NUM> is open to allow the insertion tool to extend through the spreader 300a. In some embodiments, the tip of the insertion tool will be pointed and/or sharp to assist in spearing tissue.

In one alternative embodiment, the spreader 300a comprises a transverse through-hole configured to receive soft tissue. <FIG> depicts a side view of a spreader 300a having the through-hole <NUM>. In this embodiment, tissue is captured by the anchor by threading one or more tissue bundles (for example, single or double bundles of tendon) through the through-hole <NUM>. When the anchor with threaded tissue bundles is inserted into bone, the tissue will follow a serpentine path along the sides of the anchor, through the through-hole <NUM>, and back out of the bone. In these embodiments, tissue may be captured by only threading through the through-hole <NUM> or also by piercing with the tip <NUM> of the spreader <NUM> (for example, piercing of other bundles of soft tissue).

In some embodiments, the entire anchor may be enlarged to accommodate a suitably sized through-hole <NUM> in the spreader 300a. In one non-limiting embodiment, an <NUM> diameter anchor with a <NUM> diameter through-hole <NUM> is used. In one embodiment, the through-hole is approximately <NUM> in diameter. Other sizes of through hole are contemplated.

<FIG> shows a side view of an embodiment of the spreader 300b. <FIG> shows a perspective distal view of the spreader 300b, and <FIG> shows a perspective proximal view. The spreader 300b comprises a generally flat face at distal end <NUM> and a proximal end <NUM> with a means for receiving an insertion tool <NUM>, a central body <NUM>, and a ridge <NUM>. The distal end <NUM> further comprises two holes 305a and 305b for receiving the limbs of a suture loop <NUM>. The proximal end <NUM> is configured for coupling with an inserter. For instance, in this embodiment, the proximal end <NUM> of the spreader 300b comprises a hole <NUM> that receives the inserter tool.

The spreader 300b further comprises central body <NUM> which gradually widens from the proximal end and forms a ridge <NUM> around the face <NUM>. The spreader 300b comprises a tube shaped base <NUM> at the proximal end <NUM> with a axial bore <NUM> for receiving sutures <NUM> and an insertion tool, a generally conical shaped spreader at the distal end which is wider than the proximal end, and an optional ridge <NUM> at the tip of the distal end. The distal end can further comprise a flat area around the axial bore <NUM>. The proximal end <NUM> is configured for receiving sutures and coupling with an inserter. For instance, in this embodiment, the proximal end <NUM> of the spreader 300b comprises a hole <NUM> that receives the inserter tool for coupling and sutures <NUM>.

The spreader 300b comprises the base section which joins with the gradually expanding distal spreader end <NUM>. The distal end is generally <NUM>, meaning that it gradually widens in a conical shape from the base section to the distal end of the spreader 300b, which comprises a flat area <NUM> and through which the axial bore <NUM> extends into two openings 305a, 305b. In one embodiment, the distal end may also comprise a ridge <NUM>, which may optionally be slightly undercut <NUM> to result in a stronger lock in the bone anchor when the anchor is fully deployed.

The axial bore <NUM> may be used to receive sutures (see <FIG>). In one embodiment, a loop of suture is secured through the axial bore <NUM> such that a loop of suture extends from the spreader for use in a surgical procedure. The distal end of the spreader 300b comprises two openings 305a, 305b to the axial bore <NUM> through which the suture loop <NUM> extends. The resulting length of suture extends from the proximal end of the spreader through the axial bore <NUM> and through to the distal end where it is threaded through hole 305a and then back through 305b and back through the proximal end, forming a loop. The suture loop <NUM> extending through the distal end of the spreader 300b is freely slidable, for example, such that it can be moved or adjusted back through the axial bore <NUM>.

The spreader 300b is configured to be drawn into the distal end of the anchor body <NUM> via an insertion tool. As the tissue capture anchor <NUM> is deployed, the spreader 300b is further advanced into the anchor body <NUM>, spreading the tines <NUM> of the anchor body <NUM> until the ridge <NUM> of the spreader 300b engages the groove <NUM> in the inside of the anchor body <NUM> at which point it locks into place. In one embodiment, the ridge <NUM> is undercut <NUM> providing even more security against reversing.

As discussed above, the tines <NUM> in the anchor may be in a low-profile streamlined position prior to insertion into bone. A spreader 300b is used after insertion to expand the tines <NUM> such that their teeth <NUM> engage bone. The spreader 300b may comprise any suitable shape configured to be inserted through the axial bore <NUM> in the anchor body <NUM> and make contact with the tines <NUM>. The spreader 300b may be at least partially positioned within the axial bore of the anchor prior to tine expansion as depicted in <FIG>. As the spreader 300b is moved from a first lower position to a second upper position, the proximal end of the spreader 300b is designed to spread or force the tines <NUM> from a first low-profile position (for example, an internal lateral position) to a second external lateral position. In one embodiment, the proximal end of the spreader 300b may have ridges to assist in preventing slippage or mis-alignment.

The spreader 300b will remain in the anchor with the tines <NUM> in their fully spread position. The force provided by the tines' <NUM> interaction with the bone keeps the spreader 300b tightly engaged. Further protection against slipping or tilting of the spreader 300b is provided by the optionally ridged sides of the spreader 300b. In one embodiment, the spreader 300b may have ridges or indentations to assist in a tight fit such that accidental slipping or adjustments are minimized. In one embodiment, one or more of the tines <NUM> have an indentation on a side facing the central axis of the anchor. A ridge on the spreader can then engage the indentation, thereby stabilizing the spreader 300b and preventing the spreader 300b from being advanced too far into the anchor. In an alternative embodiment, the spreader comprises an indentation (for example, an indentation in a ridge on the spreader 300b) that can engage with a protrusion on a side of a tine facing the central axis of the anchor. In addition to stabilizing the spreader 300b and preventing over insertion, this feature also prevents rotation of the spreader 300b relative to the anchor.

In this embodiment, tissue is captured by the anchor by threading one or more tissue bundles (for example, single or double bundles of tendon) through the suture loop <NUM>. The suture loop is tightened around the tendon such that the tendon is secured to the face <NUM> of the spreader 300b. Securing the tissue can be accomplished by pulling or advancing the suture loop so that it secured the tissue to the anchor <NUM>. When the anchor with threaded tissue bundles is inserted into bone, the tissue is held in place at the distal end of the spreader and will be held secure against the sides of the bone hole and further secured by the expanded tines, as described herein, along the sides of the anchor, and back out of the bone. In these embodiments, tissue may be captured by only threading through the suture loop <NUM>. In some embodiments, the suture loop may additionally comprise a knot on the end.

In a preferred embodiment, the tissue capture anchor <NUM> is made entirely of a biocompatible engineering plastic such as polyether-ether-ketone (PEEK). Other embodiments include a tissue capture anchor entirely or in part of a non-metallic substance that is biocompatible. Biocompatible materials such as poly ether ketone (PEK), polyetherimide (ULTEM), ultrahigh molecular weight polyethylene (UHMPE), polyphenylene, or some other engineering polymer materials known to those of skill in the art may be used. A non-metallic anchor system may provide certain advantages such as, for example, eliminating MRI artifacts.

<FIG> depicts individual components of an inserter tool. The inserter tool comprises an inner rod or tube <NUM>, an outer tube <NUM>, a handle body <NUM>, a threaded actuator shaft <NUM>, and a deployment knob <NUM>. In some embodiments, the inserter <NUM> is coupled to the tissue capture anchor <NUM> during manufacturing. In a preferred embodiment, the inserter tool is disposable.

The inserter tool <NUM> is designed to insert and manipulate a tissue capture anchor such the tissue capture anchor <NUM> described in <FIG>, <FIG>, <FIG> and <FIG>. In some embodiments, the tissue capture anchor <NUM> is manufactured to be attached to inserter tool before packaging. In other embodiments, the tissue capture anchor is coupled to the inserter tool prior to insertion. In a basic configuration, the inserter tool is assembled as follows: the inserter tool <NUM> is configured such that the inner rod <NUM> is disposed within the outer tube <NUM>. The outer tube is configured to fit against the proximal end of the stabilizer. The inner rod <NUM> extends through outer tube <NUM> and is configured to attach to the spreader <NUM> via threading on both the proximal hole in the spreader <NUM> and threading on the distal end of the inner rod <NUM>. The proximal end of the outer tube <NUM> is connected to a handle <NUM> and the inner rod <NUM> extends through the proximal end of the outer tube <NUM> and screws into the threaded actuator shaft <NUM>. The actuator shaft <NUM> extends just past the proximal end of the handle <NUM> where it is configured to secure with a deployment knob <NUM>.

The individual components of the inserter tool are further described in detail below.

<FIG> shows a perspective view and a side view of an embodiment of the inner rod <NUM>, respectively. In some embodiments, the inner rod is an inner tube. The inner rod comprises a distal end configured to secure to the spreader <NUM>, a proximal end which is configured to interact with the other components of the inserter, for instance the actuator shaft <NUM>. The inner rod <NUM> is configured that a proximal end is advanced through the outer tube <NUM> and into the handle <NUM> where it is further secured within the actuator shaft <NUM> via threading. The distal end of the inner rod <NUM> is configured to be advanced through the central hole in the anchor body <NUM> and then secured to the spreader <NUM> until the tissue capture anchor <NUM> is fully deployed and the inner rod <NUM> is separated from the anchor <NUM>.

The inner rod <NUM> extends through the central hole <NUM> in the anchor body <NUM> before coupling with the spreader <NUM>. In one embodiment, the inner rod <NUM> couples with the spreader <NUM> through threads on the end of the inner rod <NUM> and within the proximal end of the spreader <NUM>. In other embodiments, the inner rod <NUM> may couple to the spreader <NUM> through other securing mechanisms such as adhesives, welding or frictional fit.

<FIG> shows an embodiment of the outer tube <NUM>. The outer tube <NUM> is attached at its proximal end <NUM> to the distal end of handle <NUM> via threading <NUM>. The distal end <NUM> of the outer tube <NUM> is configured such that the inner rod <NUM> is drawn into the outer tube <NUM> and through the distal end <NUM> of outer tube <NUM> where it is secured to the spreader <NUM>. When the inner tube <NUM> is advanced far enough that the spreader <NUM> locks into place or cannot advance anymore, the outer tube <NUM> distal surface is surface-to-surface with the proximal surface of the anchor body <NUM>. When the inner rod <NUM> withdraws further into the outer tube upon the continued rotation of the deployment knob and advancement of the actuator shaft, the inner rod <NUM> strips the threading from the spreader <NUM> and the inserter tool <NUM> detaches from the anchor.

<FIG> and <FIG> show embodiments of a handle body <NUM>. <FIG> is a cut-away view of the handle body <NUM>. The proximal end of the handle <NUM> is configured to receive the deployment knob <NUM> via the ridges <NUM> which hold the knob <NUM> secure. The actuator shaft <NUM> is housed within the handle body <NUM>. A set of flat brackets or braces <NUM> secure the actuator shaft <NUM> within the handle <NUM>. The distal end of the handle is configured to receive the outer tube <NUM> via threads <NUM> at opening <NUM>. The outer tube <NUM> is permanently affixed to the handle <NUM> at its distal end.

<FIG> depicts a cross-sectional view of one embodiment of a handle <NUM>. In <FIG> the flat surface <NUM> of the bracket <NUM> is shown.

<FIG> depicts the threaded actuator shaft <NUM>. The actuator shaft <NUM> is comprised of a distal end <NUM> comprising a threaded hole <NUM> which is configured to receive the inner rod <NUM>, a second threaded portion <NUM> on the body of the shaft configured to advance the inner rod <NUM>, and a proximal end <NUM> configured to secure within the deployment knob <NUM>. The threading <NUM> of the actuator <NUM> has two flat areas <NUM>, one on each side, where there is no threading. These flat areas <NUM> fit within the flat brackets <NUM> of the handle such that the actuator <NUM> cannot rotate within the handle.

The body of the actuator shaft <NUM> is configured with threading <NUM> to permit the shaft <NUM> to advance the inner tube <NUM>. The body of the actuator shaft <NUM> is not perfectly round, but rather is oval shaped with flat sides <NUM> that are fit into the handle body <NUM> in such a way that the actuator shaft <NUM> cannot itself rotate when the deployment knob <NUM> is turned and the shaft <NUM> advances via knob <NUM>. Thus, the threads do not go all the way around the shaft but rather flatten out on the flattened sides of the shaft. The actuator shaft is configured as a coaxial system. That is, the spreader <NUM>, inner tube <NUM> and actuator <NUM> are configured to operate as one piece. The flat brackets <NUM> in the handle make the actuator shaft <NUM> stay on plane such that the actuator shaft <NUM> itself cannot rotate within the handle <NUM>. The proximal end of the inner tube <NUM> couples with the distal end of the actuator shaft <NUM> via threading.

Moving to <FIG>, a deployment knob <NUM> is shown. The deployment knob <NUM> comprises a central hole <NUM> which is configured with threading <NUM>, and a groove <NUM> configured to be received by a corresponding ridge <NUM> of the handle <NUM>. The threading <NUM> in the central hole <NUM> is configured to receive the actuator shaft <NUM>. The deployment knob <NUM> is configured to advance, relative to the deployment knob <NUM>, the inner rod <NUM> via the actuator shaft <NUM>. The actuator shaft <NUM> is joined at its proximal end to the distal end of the deployment knob <NUM> via threading <NUM> in the central hole <NUM>. The actuator shaft <NUM> is attached to the inner rod <NUM> by way of the proximal end of the inner rod <NUM> advancing into the distal end of the actuator shaft via threading so that when the deployment knob <NUM> is rotated, the mechanism of the shaft <NUM> advances the inner rod <NUM> proximally such that the spreader <NUM> is then advanced into the anchor body <NUM> to expand the anchor body <NUM> into bone and secure the tissue capture anchor <NUM>.

In one embodiment, the deployment knob <NUM> is threaded <NUM> to receive the actuator shaft via the groove <NUM> of knob <NUM> fitting with the proximal end ridge <NUM> of the handle body <NUM> As the deployment handle is turned, the actuator shaft <NUM> is advanced in a proximal direction until the anchor body <NUM> is deployed and locked into place.

<FIG> show a tissue capture anchor <NUM> coupled to the inserter tool <NUM>. The tissue capture anchor <NUM> comprises the anchor body <NUM> and the spreader <NUM>. The inserter tool <NUM>, as shown, includes the outer tube <NUM>, the handle <NUM> and the deployment knob <NUM>. The inner rod <NUM> is positioned within the outer tube <NUM>, and the outer tube is flush with the anchor body <NUM>. The outer tube <NUM> may hold the anchor body <NUM> steady during insertion and deployment. The inner rod <NUM> extends through the anchor body <NUM> and couples with the spreader <NUM> via threading. The spreader <NUM> is configured to be advanced through the distal end of the anchor body <NUM> by the inner rod <NUM> via a rotating the deployment knob <NUM>.

In another embodiment, the inner rod <NUM> extends through the spreader <NUM> which is configured such that the central hole <NUM> extends through the spreader tip <NUM>. The inner rod <NUM> is configured with a sharp, pointed tip such that the tip of the inner rod <NUM> spears or captures tissue to secure into the bone hole before the anchor body <NUM> is fully deployed.

The inner rod <NUM> provides the mechanism to draw the spreader <NUM> into the central hole <NUM> in the anchor body <NUM> to fully expand the anchor body <NUM>. During deployment of the tissue capture anchor <NUM>, the inner rod <NUM> is continually advanced via a screwing motion until the spreader locks with the anchor body. As the deployment knob <NUM> continues to turn and the inner rod <NUM> continues to pull on the threads of the spreader <NUM>, the inner rod <NUM> strips the threads from the inside of the spreader <NUM> and the insertion tool <NUM> releases from the anchor body <NUM>. Any thread shavings are contained within the outer tube <NUM>.

<FIG> illustrates an exploded view of the anchor <NUM> and the inserter <NUM>. The tissue capture anchor <NUM> comprises the anchor body <NUM> and the spreader <NUM>. The inserter tool <NUM>, as shown, includes the outer tube <NUM>, the handle <NUM> and the deployment knob <NUM>. The inner rod <NUM> is positioned within the outer tube <NUM>, and the outer tube is flush with the anchor body <NUM>. The outer tube <NUM> may hold the anchor body <NUM> steady during insertion and deployment. The inner rod <NUM> extends through the anchor body <NUM> and couples with the spreader <NUM> via threading. The spreader <NUM> is configured to be advanced through the distal end of the anchor body <NUM> by the inner rod <NUM> via a rotating the deployment knob <NUM>.

The inner rod <NUM> provides the mechanism to draw the spreader <NUM> into the central hole <NUM> in the anchor body <NUM> to fully expand the anchor body <NUM>. During deployment of the tissue capture anchor <NUM>, the inner rod <NUM> is continually advanced via a screwing motion until the spreader locks with the anchor body. As the deployment knob <NUM> continues to turn and the inner rod <NUM> continues to pull on the threads of the spreader <NUM>, the inner rod <NUM> strips the threads from the inside of the spreader <NUM> and the insertion tool <NUM> releases from the anchor body <NUM>. Any thread shavings are contained within the outer tube <NUM>. Once the anchor is deployed, the sutures are then removed via pulling them free or else cut at the top of the anchor.

In some embodiments, a pre-attached delivery handle is provided. In some embodiments, the insertion tool or delivery handle is disposable. In other embodiments, the insertion tool can be sterilized, reloaded and reused.

Those of skill in the art will appreciate other inserters and mechanisms that may be used to insert and deploy the tissue capture anchor <NUM> described herein.

Although a particular inserter device for inserting and manipulating tissue capture anchor <NUM> has been described, it should be understood that other inserter designs may be used for manipulating the parts of tissue capture anchor <NUM> described above to insert the anchor into bone and tissue to the bone. For example, it may be possible to use separate tools for inserting the anchor and deploying the anchor.

It will be appreciated that there are numerous combinations of anchors and their placement that may be used to secure soft tissue to bone by the methods (not claimed) and devices described herein. These variations as well as variations in the design of the above described anchor devices and inserter devices are within the scope of the present disclosure.

In another embodiment, anchors as described herein are used for anterior cruciate ligament (ACL) repair. In one embodiment, a femoral tunnel is drilled in the femur. One or two bundles of tendon are then fed through the suture loop <NUM> of the spreader <NUM>. The anchor <NUM> is then inserted into the bone and deployed as discussed below.

In various embodiments, soft tissue may be attached to bone utilizing one or more tissue capture anchors. In one non-limiting example, depicted in <FIG>, a suture loop is coupled to the distal end of the anchor. <FIG> depicts a side view of a tissue capture anchor <NUM> comprising an anchor body <NUM>, a spreader <NUM>, and a suture loop <NUM>. The anchor body <NUM> is comprised of tines <NUM> and one or more teeth <NUM>. The tines <NUM> expand from the distal end of the anchor body <NUM> when the spreader <NUM> is engaged with the anchor body <NUM>. The proximal end of the spreader <NUM> is configured to fit around the outside of the proximal end <NUM> of the anchor body <NUM>. In <FIG>, the tissue capture anchor <NUM> is in the undeployed, or unexpanded position.

<FIG> shows a perspective view of the unexpanded tissue capture anchor <NUM>. In this embodiment, the anchor body <NUM> is slightly inserted in the central hole <NUM> at the proximal end of the spreader <NUM>.

<FIG> shows a side view of the tissue capture anchor <NUM> in the deployed or expanded position. In the deployed or expanded position, the spreader <NUM> has been drawn up in between the tine <NUM> causing them to expand from the distal end of the anchor body <NUM> through openings in the spreader <NUM>. When deployed, the one or more teeth <NUM> engage with the bone surface trapping tissue between the bone and the bone anchor <NUM>.

The distal end of the anchor body <NUM> may comprise a grooved surface <NUM> to engage with the ridge <NUM> of the spreader <NUM> to lock the spreader <NUM> into place when the anchor body <NUM> is fully deployed. The grooved surface <NUM> is oriented such that the distal end of the spreader <NUM> can be easily moved in the proximal direction in between the tines <NUM>. The spreader <NUM> fits over the proximal end of the anchor body <NUM>, via the central hole <NUM> of the spreader <NUM> with the ridge <NUM> snapping into the groove <NUM> as the distal end of the spreader <NUM> is moved proximally. However, when the ridge <NUM> is snapped into groove <NUM>, proximal movement of distal end is inhibited. In some embodiments, the groove <NUM> can exist at different locations of the surface of the central hole or else even along substantially the entire surface of the central hole <NUM>. In some embodiments the anchor body <NUM> may be coupled to the spreader <NUM> in several positions. In other words, in one embodiment the spreader <NUM> need not be inserted over the anchor body <NUM> as far as it will go for it to be secured to the anchor body <NUM>.

It will be appreciated that other shapes are also contemplated, including multiple concentric grooves, a series of protruding ridges, or any other suitable structure that permits an anchor <NUM> to be securely locked within the central hole of the spreader <NUM>.

With reference to <FIG>, which is a perspective view of the top and side of anchor body <NUM> engaged with the spreader <NUM>, the top (proximal end) of the spreader <NUM> comprises a hole <NUM> in the center for receiving the anchor body <NUM>. In some embodiments, the top surface <NUM> of the spreader <NUM> may be textured such as with a scallop shape or grooves so as to inhibit movement of an insertion tool against the surface of the spreader.

During deployment, the spreader <NUM> is drawn proximally in between the tines <NUM> causing them to expand from the distal end of the anchor body <NUM>. Also during deployment, the spreader <NUM> is drawn proximally until the ridge <NUM> of the spreader <NUM> passes a groove <NUM> in the anchor body <NUM>. When the spreader passes this point, the ridge <NUM> and groove <NUM> engage or click and the spreader <NUM> is locked into place and the anchor body <NUM> cannot undeploy or reverse and the spreader <NUM> cannot reverse direction.

<FIG> shows a distal end view of the tissue capture anchor <NUM>. In this view the anchor body <NUM> is fully deployed. The spreader <NUM> is securedly fixed between the tines <NUM> and the ridge <NUM> and groove <NUM> of the anchor body <NUM> will keep the spreader <NUM> from being uninserted or reversed from the anchor body <NUM>. The tines <NUM> are fully expanded. Since the teeth <NUM> are facing the opposite direction from the view of <FIG>, only their edges are visible along the edges of the tines <NUM>.

<FIG> depict an embodiment of an undeployed anchor body <NUM>. <FIG> depicts a side view of the anchor body <NUM>. <FIG> depicts a perspective view of an embodiment of the anchor body <NUM>. <FIG> depicts a view from the proximal end, or base, of the anchor body <NUM>, and <FIG> depicts a perspective view from the distal end, or tines, of the anchor body <NUM>. The proximal end of the undeployed anchor body <NUM> is generally comprised of a slightly rectangular shaped structure which is flat on at least two sides. The anchor body <NUM> tapers distally into at least two tines. The anchor body <NUM> generally comprises a shape complementary with the spreader, with flat sides and with a diameter larger than distal end <NUM>. In some embodiments, the proximal end of the anchor body is rounded. In other embodiments, the proximal end of the anchor body is rectangular. With reference to <FIG>, a hole <NUM> may advantageously be provided in the center of proximal end <NUM>. With reference to <FIG>, the bottom of distal end <NUM> includes two tines <NUM>, or projections which originate from about half to a third of the way distally from the proximal end of the bone anchor <NUM>. At the point where the tines begin to project from the proximal end of the anchor body, is the other end of hole <NUM>. Central hole <NUM> comprises a central opening that extends through the anchor body <NUM>. In some embodiments the anchor body <NUM> comprises a groove <NUM> in its inner surface, as shown in <FIG>. Thus, the inner surface of the anchor body <NUM> is not flat. In some embodiments, some or all of these surfaces may be textured such as with a scallop shape or grooves so as to inhibit movement of the wedge portion <NUM> of spreader <NUM> once it is withdrawn into the anchor body. In some embodiments, texturing in the outer surfaces of anchor body <NUM> matches texturing in the inner surfaces of the spreader <NUM>. It will be appreciated that the illustrated embodiments represent only one possibility; thus, other shapes for the surface of proximal end <NUM> may also be used.

During assembly, the distal end <NUM> of the anchor body <NUM> is configured to be received within the proximal end of spreader <NUM>. Hole <NUM> in anchor body <NUM> is an opening into a central ("axial") bore into and through the proximal end of the anchor body <NUM>.

The sides of the tines <NUM> preferably include a groove for engaging with the spreader <NUM>. It will be appreciated that other methods (not claimed) of securing the wedge portion <NUM> of the spreader <NUM> within the anchor body <NUM> may be used, such as a frictional fit or threading.

The anchor body <NUM> is comprised of one or more tines <NUM> which spread outwardly when engaged with the spreader <NUM>. In one embodiment shown in these figures, there are two tines. The tines <NUM> engage with the bone, fixedly securing the anchor body <NUM> in the bone. The tines comprise a number of teeth <NUM> which further engage with the tissue and bone in the deployed tissue capture anchor <NUM>. The number of tines <NUM> and teeth <NUM> can vary. In one embodiment, there are two tines <NUM> with one tooth <NUM> per tine <NUM>. The proximal end <NUM> of the anchor body <NUM> is configured to receive an inserter component, which is inserted through the hole <NUM> in the center of the anchor body <NUM> and is coupled with a spreader <NUM>. In one embodiment, the spreader is attached and deployed as disclosed above.

<FIG> shows a side view of an embodiment of the spreader <NUM>. <FIG> shows a perspective view of the spreader <NUM>. The spreader <NUM> comprises a generally inwardly curved face at distal end <NUM> and a proximal end <NUM> comprising an axial bore <NUM> for receiving an insertion tool <NUM>, a central body <NUM>, a triangular-shaped expander portion <NUM>, and a ridge <NUM>. The distal end <NUM> further comprises two holes 1305a and 1305b for receiving a suture loop <NUM>. The proximal end of the wedge <NUM> is configured for coupling with an inserter. In one embodiment, the inserter used is as described above. For instance, in this embodiment, the proximal end <NUM> of the spreader <NUM> comprises a hole <NUM> that receives the inserter tool for coupling.

The distal end <NUM> of the spreader <NUM> may advantageously be tapered to facilitate insertion of the spreader <NUM> into bone.

The spreader <NUM> further comprises central body <NUM> which gradually narrows from the proximal end The distal portion of the spreader forms a ridge (or groove) <NUM> just proximal to the curved face at distal end <NUM>. The distal end <NUM> of spreader <NUM> comprises axial bores 1305a and 1305b for receiving sutures <NUM> and axial bore <NUM> which optionally receives an insertion tool. The distal end comprises a rounded area <NUM> for securing tissue in place. The proximal end <NUM> is configured for coupling with an anchor body <NUM> and optionally receives an inserter. For instance, in this embodiment, the proximal end <NUM> of the spreader <NUM> comprises a hole <NUM> that receives the anchor body <NUM>. In one embodiment, sutures <NUM> are received into one of holes 1305a and 1305b from a location exterior to the inserter, looped, threaded into the other of holes 1305a and 1305b and returned along the exterior of the insertion tool to the proximal end of the insertion tool where the surgeon can secure the sutures <NUM>.

The spreader <NUM> comprises a proximal section comprising a hole for receiving the bone anchor <NUM>. The spreader <NUM> comprises a distal section which further comprises a wedge <NUM> at the interior distal end of the spreader. This distal portion of the spreader including the wedge-shaped portion <NUM> is configured to fit between the tines <NUM> of the anchor and advance the tines outward as the insertion tool deploys the anchor <NUM>.

In one embodiment, a loop of suture is secured through the axial bores 1305a and 1305b from a location exterior to the insertion tool such that a loop of suture extends from the spreader for use in a surgical procedure. The distal end of the spreader <NUM> comprises two openings 1305a, 1305b through which the suture loop <NUM> extends. The resulting length of suture extends from the proximal end of the inserter tool <NUM> to the distal end where the suture <NUM> is threaded through hole 1305a forms a loop, and then back through 1305b and extending once again to the proximal end of the insertion tool. The suture loop <NUM> extending through the distal end of the spreader <NUM> is freely slidable, for example, such that it can be moved or adjusted back through the holes 1305a and 130b. In one alternate embodiment, the axial bore <NUM> may be used to receive sutures.

The spreader <NUM> is configured to be drawn in between the tines <NUM> via an insertion tool. As the tissue capture anchor <NUM> is deployed, the spreader <NUM> is advanced, such that the wedge shaped portion <NUM> of spreader <NUM> is advanced between the tines <NUM> of the distal end of anchor body <NUM>, spreading the tines <NUM> of the anchor body <NUM> until the ridge <NUM> of the spreader <NUM> engages the groove <NUM> in the inside of the anchor body <NUM> at which point it locks into place. In one embodiment, the ridge <NUM> is undercut <NUM> providing even more security for reversing.

As discussed above, the tines <NUM> in the anchor may be in a low-profile streamlined position prior to insertion into bone. A spreader <NUM> is used after insertion to expand the tines <NUM> such that their one or more teeth <NUM> engage bone. The wedge portion <NUM> of the spreader <NUM> may comprise any suitable shape configured to be inserted through the axial bore <NUM> in the anchor body <NUM> and make contact with the tines <NUM>. The wedge portion <NUM> of the spreader <NUM> may be at least partially positioned within the axial bore of the bone anchor prior to tine expansion as depicted in <FIG>. As the spreader <NUM> is moved from a first lower position to a second upper position, the proximal end of the wedge <NUM> of spreader <NUM> is designed to spread or force the tines <NUM> from a first low-profile position (for example, an internal lateral position) to a second external lateral position. In one embodiment, the proximal end of the spreader <NUM> may have ridges to assist in preventing slippage or mis-alignment.

The spreader <NUM> will remain in a locked position with the anchor body <NUM> with the tines <NUM> in their fully spread position. The force provided by the tines' <NUM> expansion and compression interaction with the bone walls keeps the spreader <NUM> tightly engaged. Further protection against slipping or tilting of the spreader <NUM> is provided by the optionally ridged sides of the spreader <NUM>. In one embodiment, the spreader <NUM> may have ridges or indentations to assist in a tight fit such that accidental slipping or adjustments are minimized. In one embodiment, one or more of the tines <NUM> have an indentation on a side facing the central axis of the anchor. A ridge on the spreader can then engage the indentation, thereby stabilizing the spreader <NUM> and preventing the spreader <NUM> from being advanced too far into the anchor. In an alternative embodiment, the spreader comprises an indentation (for example, an indentation in a ridge on the spreader <NUM>) that can engage with a protrusion on a side of a tine facing the central axis of the anchor. In addition, to stabilizing the spreader <NUM> and preventing over insertion, this feature also prevents rotation of the spreader <NUM> relative to the anchor.

In this embodiment, tissue is captured by the anchor by threading one or more tissue bundles (for example, single or double bundles of tendon) through the suture loop <NUM>. The suture loop is secured around the tendon such that the tendon is secured to or within the curved portion <NUM> of the spreader <NUM>. When the anchor with threaded tissue bundles is inserted into bone, the tissue is held into place at the distal end of the spreader and will be held secure against the sides of the bone hole and further secured by the expanded tines, as described herein, along the sides of the anchor, and back out of the bone. In these embodiments, tissue may be captured by only threading through the suture loop <NUM>.

In the preferred embodiment, the tissue capture anchor <NUM> is made entirely of a biocompatible engineering plastic such as polyether-ether-ketone (PEEK). Other embodiments include a tissue capture anchor entirely or in part of a non-metallic substance that is biocompatible. Biocompatible materials such as poly ether ketone (PEK), polyetherimide (ULTEM), ultrahigh molecular weight polyethylene (UHMPE), polyphenylene, or some other engineering polymer materials known to those of skill in the art may be used. A non-metallic anchor system may provide certain advantages such as, for example, eliminating MRI artifacts.

The inserter tool shown in <FIG> depicts individual components of an inserter tool used in conjunction with the anchor <NUM>. The inserter tool comprises an inner rod or tube <NUM>, an outer tube <NUM>, a handle body <NUM>, a threaded actuator shaft <NUM>, and a deployment knob <NUM>. In some embodiments, the inserter <NUM> is coupled to the tissue capture anchor <NUM> during manufacturing. In a preferred embodiment, the inserter tool is disposable.

The inserter tool <NUM> is designed to insert and manipulate a tissue capture anchor such the tissue capture anchor <NUM> described in <FIG> and <FIG>. In some embodiments, the tissue capture anchor <NUM> is manufactured to be attached to the inserter tool before packaging. In other embodiments, the tissue capture anchor is coupled to the inserter tool prior to insertion. In a basic configuration, the inserter tool is assembled as follows: the inserter tool <NUM> is configured such that the inner rod <NUM> is disposed within the outer tube <NUM>. The outer tube is configured to fit against the proximal end of the anchor body <NUM>. The inner rod <NUM> extends through outer tube <NUM> and is configured to attach to the spreader <NUM> via threading within the hole in the spreader <NUM> and threading on the distal end of the inner rod <NUM>. The proximal end of the outer tube <NUM> is connected to a handle <NUM> and the inner rod <NUM> extends through the proximal end of the outer tube <NUM> and screws into the threaded actuator shaft <NUM>. The actuator shaft <NUM> extends just past the proximal end of the handle <NUM> where it is configured to secure with a deployment knob <NUM>. Suture <NUM> is threaded through the around the cleat in the handle and is permitted to freely extend down the exterior of the outer tube to the distal end of the spreader where it is threaded through holes 1305a and 1305b forming a loop and extending back up the length of the outer tube to the proximal end of the inserter tool. In some embodiments, the suture <NUM> is wound around the cleat on the handle.

The individual components of the inserter tool are described above, and illustrated in <FIG>.

<FIG> shows an exploded view of the tissue capture anchor and the inserter. <FIG> shows a tissue capture anchor <NUM> coupled to the inserter tool <NUM>. The tissue capture anchor <NUM> comprises the anchor body <NUM> and the spreader <NUM>. The inserter tool <NUM>, as shown, includes the outer tube <NUM>, the handle <NUM> and the deployment knob <NUM>. The inner rod <NUM> is positioned within the outer tube <NUM>, and the outer tube is flush with the anchor body <NUM>. The outer tube <NUM> may hold the anchor body <NUM> steady during insertion and deployment. The inner rod <NUM> extends through the anchor body <NUM> and couples with the spreader <NUM> via threading. The spreader <NUM> is configured to be advanced through the distal end of the anchor body <NUM> by the inner rod <NUM> via rotating the deployment knob <NUM>.

Those of skill in the art will appreciate other inserters and mechanisms that may be used to insert and deploy the tissue capture anchors <NUM> and <NUM> described herein.

Although a particular inserter device for inserting and manipulating tissue capture anchors <NUM> and <NUM> have been described, it should be understood that other inserter designs may be used for manipulating the parts of tissue capture anchors <NUM> and <NUM> described above to insert the anchor into bone and tissue to the bone. For example, it may be possible to use separate tools for inserting the anchor and securing tissue capture anchor.

It will be appreciated that there are numerous combinations of anchors and their placement that may be used to secure soft tissue to bone by the methods (not claimed) and devices described herein.

Various embodiments include methods for attaching soft tissue to bone. In some embodiments, the methods include using the tissue capture anchors described above. In one preferred embodiment, a biceps tenodesis procedure is performed arthroscopically.

The biceps tendon connects the biceps muscle to the bone. The biceps tendon connects the biceps muscle to the bone. The tendon passes from the muscle to the shoulder joint. Biceps tendon problems can also occur in conjunction with a rotator cuff tear.

A biceps tenodesis is often, but not always, performed in patients with significant biceps tendon symptoms, and evidence at the time of arthroscopy of biceps tendon inflammation or tears.

The procedure using a tissue capture anchor described herein merely requires drilling the bone hole and capturing the tendon with the anchor and dragging the tendon into the bone hole. In some embodiments, a further advantage when using an awl to make the bone hole is that the whole procedure can be percutaneous.

In a preferred method (not claimed), the procedure is performed arthroscopically. A percutaneous approach may be used in the alternative. In one embodiment, a <NUM> PEEK tissue capture anchor is used, although different sizes and materials may be used. In some instances the hole into which the tissue capture anchor will be inserted is made by making a clearance hole for the anchor in the superior portion of the bicipital groove <NUM> using a drill bit or suitably sized awl. In one embodiment, the hole is made by the spreader <NUM> tip after the spreader <NUM> captures the tissue to be secured. The hole may also be made in any other suitable position depending on pathology of the tendon, etc. <FIG> and <FIG> show different views of the bicipital groove and surrounding bone of the shoulder and biceps. The bicipital groove is a furrow on the upper part of the humerus occupied by the long head of the biceps and is also called the intertubercular groove. In some embodiments a <NUM> drill bit is used; however in other embodiments, a different sized drill bit can be used. In one embodiment, the clearance hole can range from <NUM> wide to <NUM> wide. In other embodiments, the size of the clearance hole will vary, as the size depends on the size of the anchor. Depending on the softness of the bone and the size of the anchor, the hole can be from <NUM> - <NUM> deep. For example, in one embodiment, a <NUM> tissue capture anchor is used, and for soft bone, the hole can be at least <NUM> deep. For average bone, the hole can be approximately <NUM>-<NUM> deep. For very soft bone, the hole can be approximately <NUM>.

The implantation site is cleared of any soft tissue in the region of the bone hole using a bur or other suitable means. When the hole in the bone is pre-drilled, the hole is advantageously drilled with a diameter smaller than the diameter of anchor body <NUM> and spreader <NUM> so that the tines can engage the bone through the sides of the hole. Angled protrusions or teeth may be used that provide greater resistance to removal of the anchor body <NUM> than to insertion. As shown in <FIG>, the tendon will then be captured by the anchor and forced into the clearance hole and the anchor deployed as shown in <FIG>. As shown in <FIG>, the tendon is essentially folded around the anchor longitudinally resulting in a double surface contact. As described above, the tendon may be captured using a variety of methods (not claimed) including spearing with the anchor of <FIG>, threading tissue through the through-hole in the anchor of <FIG>, and threading tissue through the suture loop in the anchors of <FIG> and <FIG>.

In one nonlimiting embodiment, the shoulder preparation is as that used by <NPL>). The shoulder will undergo soft tissue dissection to the level of the rotator cuff. At this point, the surpraspinatus tendon insertion is reflected by sharp dissection and the long head biceps tendon inspected for any evidence of pathology. The tendon of the LHB is then sharply incised, freeing from its intra-articular origin at the superior aspect of the glenoid as well as dividing it as the musculotendinous junction so that the biceps tendon is a free segment. In other embodiments, other methods of shoulder preparation are used.

Repairs are complete by drilling a clearance hole for the anchor in the superior portion of the bicipital groove using a standard drill bit. As shown in <FIG>, the tendon will then be captured by the anchor and forced in to the clearance hole and the anchor placed to capture the tendon. The tendon will be essentially folded around the anchor longitudinally, resulting in a double surface contact. The proximal surface of the anchor will be situated flush with the cortical surface.

In another embodiment, anchors as described below are used for anterior cruciate ligament (ACL) repair. In this embodiment, a femoral tunnel is drilled in the bone. One or two bundles of hamstring tendon are captured by the anchor. The anchor is then inserted into the bone and deployed as discussed above. As described above, the tendon may be captured using a variety of methods (not claimed) including spearing with the anchor of <FIG>, threading tissue through the through-hole in the anchor of <FIG>, and threading tissue through the suture loop in the anchors of <FIG> and <FIG>.

The bone anchor is made of any acceptable material. In one embodiment, the anchor is made of PEEK. The procedure using the PEEK tissue capture anchor merely requires drilling the bone hole and "capturing" the tendon within the suture loop of the anchor, dragging the tendon into the bone hole. In some embodiments, the tendon is captured using a spear tip. In one embodiment, the suture loop is used to capture and secure the tendon. In some embodiments, a further advantage when using an awl to make the bone hole is that the whole procedure can be percutaneous.

In one embodiment, a hole is drilled in to the bone at a diameter of about <NUM>. The anchor is positioned such that a grasper tool can be implemented to grasp a tendon through the suture loop and secure the suture around the tendon. The tendon can then be manipulated and moved or positioned. In one embodiment, a double bundle of tendons is inserted into a single bone tunnel in the femur. In one embodiment, a gracilis and a semitendinosus tendon are both doubled over for insertion into the bone hole. The anchor, which, in one embodiment may be about <NUM> or <NUM> in diameter, is inserted into the bone hole with the doubled over tendons. Due to the size of the hole, the anchor, which may be <NUM> or <NUM> in diameter is inserted with the doubled over tendons draped over its tip into the hole. The anchor is also suited for single bundle single tunnel and single bundle double tunnel procedures. In other embodiments, the bone hole and the anchor can be difference sizes as needed.

In one embodiment, the surgeon drills through the tibia and up into the femur and loads the anchor plus tendons through the tibial tunnel. In one embodiment, an anteromedial portal is used to drill the femoral tunnel and a separate tibial tunnel.

Claim 1:
A tissue capture anchor (<NUM>) for attaching tissue to bone, the anchor (<NUM>) comprising:
an anchor body (<NUM>) comprising a proximal end (<NUM>) and at least two expandable tines (<NUM>) distally extending from the proximal end (<NUM>) and having a non-threaded inner surface; and
a spreader (<NUM>) configured to engage with the anchor body (<NUM>) at the non-threaded inner surface, the spreader (<NUM>) comprising:
a distal end comprising a suture loop (<NUM>);
a central hole (<NUM>) adapted to receive the proximal end (<NUM>) of the anchor body (<NUM>); and
an angled portion (<NUM>), interior to the spreader (<NUM>), configured to force the expandable tines (<NUM>) outward as the spreader (<NUM>) is moved relative to the anchor body (<NUM>), wherein the suture loop (<NUM>) is configured to receive tissue.