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

The disclosure relates furthermore to procedures and methods 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. Bone anchors for securing soft tissue to a bone are known from <CIT>, <CIT>, <CIT> and <CIT>.

Some embodiments relate to a bone anchor. A bone anchor can include, for example, a bone engaging member having a first proximal bone engaging portion and a second distal bone engaging portion and an expansion feature that allows radial expansion of the first bone engaging portion and the second bone engaging portion. A bone anchor can further include an expander with a first proximal expansion portion and a second distal expansion portion and displaceable between a first position relative to the bone engaging member and a second position relative to the bone engaging member and a tissue capture feature. In some embodiments, the first expansion portion of the expander can expand the first bone engaging portion of the bone engaging member and the second expansion portion of the expander can expand the second bone engaging portion of the bone engaging member when the expander is in the second position.

Some embodiments relate to a bone anchor. A bone anchor can include, for example, a bone engaging member having a first end and a second end. The bone engaging member can include a first plurality of bone-engaging tines extending longitudinally towards the first end, a second plurality of bone-engaging tines extending longitudinally towards the second end, and an expander having a first portion and a second portion positioned along a longitudinal axis. In some embodiments, the expander can be positioned between the first plurality of bone engaging tines when the expander is in a first position. In some embodiments, the expander is positioned between the first plurality of bone engaging tines and between the second plurality of bone engaging tines when the expander is in a second position. In some embodiments, the expander can expand both the first set of tines and the second set of tines outward upon movement of the expander relative to the bone-engaging member from a first position to a second position.

Some embodiments relate to a bone anchor. A bone anchor can include, for example, a bone engaging member having a first proximal bone engaging portion and a second distal bone engaging portion and an expansion feature that allows radial expansion of the first bone engaging portion and the second bone engaging portion. Some embodiments of a bone anchor can include a two piece expander having a first expansion member with a first expansion portion and a second expansion member with a second expansion portion. In some embodiments, the first expansion member and the second expansion member can be displaceable between first positions relative to the bone engaging member and second positions relative to the bone engaging member. Some embodiments of a bone anchor can include a tissue capture feature. In some embodiments of a bone anchor, the first expansion portion of the first expansion member can expand the first bone engaging portion of the bone engaging member and the second expansion portion of the second expansion member can expand the second bone engaging portion of the bone engaging member when first and second expansion members are in their second positions.

Some embodiments relate to a method of attaching soft tissue to bone. The method can include, for example, inserting tissue and an anchor having a first expandable bone engaging portion at a first end of the anchor and a second expandable bone engaging portion at a second end of the anchor into the bone, expanding the first expandable bone engaging portion of the anchor to engage the bone, and expanding the second expandable bone engaging portion of the anchor to engage the bone.

In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of this disclosure.

Some embodiments disclosed herein relate generally to anchors for use in anchoring tissue or objects in a body. More specifically, some embodiments disclosed herein relate generally to anchors for use in anchoring soft tissue to bone in a body. Some embodiments disclosed herein relate generally to anchors for use in anchoring sutures to a bone in a body. Also some elements relate to individual components and subcomponents of the systems described herein, as well as methods of making and using the same. Some embodiments additionally relate to kits and components used in connection with the anchor. Although the following embodiments refer to the use of an anchor in anchoring tissue, a person of skill in the art will recognize that an anchor can be used to anchor any range of items within a body.

An exemplary dual expansion anchor can include features configured for retention of the desired tissue and features configured for affixing the anchor to the desired anchor point. <FIG> depicts a perspective view of one embodiment of an unexpanded dual expansion anchor <NUM> comprising an anchor body <NUM> and an expander <NUM>. An anchor has a distal end <NUM> and a proximal end <NUM>. The anchor <NUM> depicted in <FIG> has a radius of r1. An anchor can have a variety of dimensions. In some embodiments, for example, an anchor can have a length of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or any other desired length. In some embodiments, for example, an anchor can have a diameter of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or any other desired diameter.

The anchor body <NUM> has a first end <NUM> and a second end <NUM>. In some embodiments, the first end <NUM> of the anchor body <NUM> is configured for placement into an anchor location. In some embodiments, the first end <NUM> of the anchor body <NUM> is configured for placement into a hole in a bone. In some embodiments, the second end <NUM> of the anchor body <NUM> is likewise configured for placement into an anchor location, or into a hole in a bone. In some embodiments, the anchor <NUM> is placed in the hole in the bone so that the second end <NUM> is in closer proximity to the entrance hole into the bone than the first end <NUM>.

An anchor <NUM> can be inserted into an anchor point with an insertion tool. In some embodiments, the second end <NUM> of the anchor body <NUM> is configured for interaction with a portion of the insertion tool to thereby allow placement of the anchor <NUM> at the anchor point. In some embodiments, the second end <NUM> of the anchor body <NUM> can be configured to abut portions of the insertion tool. The abutting interaction between the anchor body <NUM> and the insertion tool can facilitate a transfer of forces between the insertion tool and the anchor body <NUM>, which transfer of forces can facilitate anchor insertion and/or result in deployment or expansion of the anchor <NUM>.

The anchor body <NUM> depicted in <FIG> has an axial bore <NUM>. The axial bore <NUM> can extend partially or entirely through the anchor body <NUM>. In some embodiments, the axial bore <NUM> can be a first axial bore partially extending along the length of the anchor body <NUM> and a second axial bore partially extending along the length of the anchor body <NUM>. The axial bore <NUM> depicted in <FIG> extends the entire length of the anchor body <NUM>.

The axial bore <NUM> can be sized and dimensioned to receive the expander <NUM>. The expander <NUM> depicted in <FIG> is partially disposed within the axial bore <NUM> of the anchor body <NUM>. The size and dimensions of the axial bore <NUM> will be discussed at greater length below.

The anchor body <NUM> depicted in <FIG> has an expansion slot <NUM> and teeth (or ridges) <NUM>(a), <NUM>(b). The expansion slot <NUM> allows the expansion of the anchor body <NUM> when the expander <NUM> is moved longitudinally in a direction from the first end <NUM> towards the second end <NUM>. When the anchor <NUM> is placed within a hole in a bone, the longitudinal displacement of the expander <NUM> towards the second end <NUM> of the anchor body <NUM> results in the radial expansion of the anchor body <NUM>. In some embodiments, the anchor body can be sized and dimensioned relative to the hole in which the anchor <NUM> is placed, so that the radial expansion of the anchor body resulting from the longitudinal displacement of the expander <NUM> towards the second end <NUM> causes the teeth <NUM>(a), <NUM>(b) to engage with bone surrounding the hole in which the anchor <NUM> is positioned. In some embodiments, the teeth <NUM>(a), <NUM>(b) are designed to prevent the anchor <NUM> from displacing out of the bone. In some embodiments, the teeth <NUM>(a), <NUM>(b) are designed to stabilize the anchor <NUM> in the bone. In some embodiments, the teeth <NUM>(a), <NUM>(b) are designed to hold the anchored tissue in proximity to the bone. In some embodiments, the teeth <NUM>(a), <NUM>(b) are designed to perform a combination of these and other functions.

In some embodiments, the teeth <NUM>(a), <NUM>(b) may penetrate the bone, the teeth <NUM>(a), <NUM>(b) may partially penetrate the bone, the teeth <NUM>(a), <NUM>(b) may form depressions in the bone, or the teeth <NUM>(a), <NUM>(b) may deform to fit to the bone.

In some embodiments, all of the teeth <NUM>(a), <NUM>(b) on the anchor body <NUM> are similarly sized and dimensioned. As depicted in <FIG>, an anchor body <NUM> may also have two or more types of teeth <NUM>(a), <NUM>(b). Specifically, as depicted in <FIG>, and anchor body may have a first set of teeth <NUM>(a) located proximate to the first end <NUM> of the anchor body <NUM> and a second set of teeth <NUM>(b) located proximate to the second end <NUM> of the anchor body <NUM>.

As depicted in <FIG>, teeth <NUM>(a), <NUM>(b) can have a range of sizes and shapes. A first set of teeth <NUM>(a) can be sized and shaped to particularly resist movement in one direction. A first set of teeth <NUM>(a), as depicted in <FIG>, sized and shaped to particularly resist movement in one direction can be asymmetrical. A second set of teeth <NUM>(b) can be sized and shaped to equally resist movement in all directions. A second set of teeth <NUM>(b), sized and shaped to equally resist movement in all directions can be symmetrical.

<FIG> depicts a perspective view of the same embodiment of the dual expansion anchor <NUM> comprising an anchor body <NUM> and an expander <NUM> depicted in <FIG>. As also depicted in <FIG>, the body <NUM> of the anchor <NUM> depicted in <FIG> has a first end <NUM>, a second end <NUM>, an axial bore <NUM>, an expansion slot <NUM>, and teeth <NUM>(a), <NUM>(b). As depicted in <FIG>, the expander <NUM> is completely positioned within the axial bore <NUM> of the anchor body <NUM>. With the expander <NUM> positioned completely within the axial bore <NUM> of the anchor body <NUM>, the anchor <NUM> has a new radius r2. The expansion of the anchor body <NUM> caused by the new positioning of the expander <NUM> results in radius r2 being larger than radius r1 of the anchor <NUM> depicted in <FIG>. Additionally, while <FIG> depicts an anchor <NUM> defined by a single radius rl, a person of skill in the art will recognize that a plurality of non-constant radii define some embodiments of an anchor <NUM>. Thus, an expanded anchor <NUM> may have uniform or non-uniform radial expansion between a first end <NUM> and a second end <NUM>.

The anchor <NUM> can have a variety of expanded dimensions. In some embodiments, for example, radius r2 is constant across the length of the anchor <NUM>. In some embodiments, radius r2 varies across the length of the anchor <NUM>. As depicted in <FIG>, in some embodiments, radius r2 increases as the longitudinal distance to the first end <NUM> of the anchor <NUM> decreases.

<FIG> depicts a perspective cut-away view of the same embodiment of the dual expansion anchor <NUM> comprising an anchor body <NUM>. The body <NUM> of the anchor <NUM> depicted in <FIG> has a first end <NUM>, a second end <NUM>, an axial bore <NUM>, an expansion slot (not shown), and teeth <NUM>(a), <NUM>(b). An axial bore <NUM> has a longitudinal axis <NUM> and can comprise a variety of shapes and sizes. In some embodiments, an axial bore may have a single shape and constant diameter throughout the length of the anchor body <NUM>. In some embodiments, and as depicted in <FIG>, the shape and size of the axial bore <NUM> may vary along the length of the anchor body <NUM>. A person of skill in the art will recognize that variations in the shape and size of the axial bore <NUM> can be used in connection with variations in the size and shape of the expander (not shown) to achieve desired expansion of the anchor body <NUM>, to achieve desired placement of the expander (not shown) within the anchor body <NUM>, and to facilitate and/or prevent certain movements of the expander (not shown) within the anchor body <NUM>.

As depicted in <FIG>, and axial bore <NUM> can comprise portions that are parallel to the longitudinal axis <NUM> of the axial bore <NUM>, perpendicular to the longitudinal axis <NUM> of the axial bore <NUM>, or angled relative to the longitudinal axis <NUM> of the axial bore <NUM>. The axial bore <NUM> can comprise a sloped portion <NUM>. As depicted in <FIG>, the sloped portion <NUM> can be located proximate to the first end <NUM> of the anchor body <NUM>. The sloped portion <NUM> can be configured to provide a cam surface for the expander (not shown) to facilitate movement of the expander (not shown) into the axial bore <NUM> and to thereby facilitate increasing of the radius of the anchor body <NUM> from radius r1 to radius r2.

An axial bore <NUM> can include a first stop <NUM>. As depicted in <FIG>, a first stop <NUM> is a wall non-parallel, and in some embodiments, for example, perpendicular to the longitudinal axis <NUM> of the anchor body <NUM>. As depicted in <FIG>, the first stop <NUM> can be configured to provide an engageable surface to interact with portions of the expander (not shown) and thereby prevent the retraction of the expander (not shown) once the expander (not shown) has advanced past a designated point. Advantageously, prevention of the retraction of the expander (not shown) enables permanent placement of an anchor <NUM> in bone.

A first stop can be located a desired distance from the first end so as to achieve a desired degree of spreading of the first end <NUM> of the anchor body <NUM>. In some embodiments, the first stop <NUM> can be located so that the first end <NUM> of the anchor body <NUM> achieves an expanded radius of approximately <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeter, or any other desired diameter.

An axial bore <NUM> can include a second stop <NUM>. As depicted in <FIG>, a second stop <NUM> is a wall perpendicular to the longitudinal axis <NUM> of the anchor body <NUM>. The second stop <NUM> can be configured to provide an engageable surface to interact with portions of the expander (not shown) and thereby prevent the retraction of the expander (not shown) once the expander (not shown) has advanced past a designated point. Advantageously, prevention of the retraction of the expander (not shown) enables the permanent placement of an anchor <NUM> in bone.

A second stop <NUM> can be located a desired distance from the first end <NUM> so as to achieve a desired degree of spreading of the second end <NUM> of the anchor body <NUM>. In some embodiments, the second stop <NUM> can be located so that the second end <NUM> of the anchor body <NUM> achieves an expanded radius of approximately <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeter, or any other desired diameter.

An axial bore <NUM> can include a third stop <NUM>. As depicted in <FIG>, a third stop <NUM> can be a wall perpendicular to the longitudinal axis <NUM> of the anchor body <NUM>. As depicted in <FIG>, the third stop <NUM> can be configured to provide an engageable surface to interact with portions of the expander (not shown) and thereby prevent the advancement of the expander (not shown) past a designated point. Advantageously, prevention of advancement of the expander (not shown) past a designated point allows consistent expansion of the anchor body <NUM> and prevents failure of the anchor <NUM> placement due to over penetration of the expander (not shown) into the anchor body <NUM>.

<FIG> depicts a perspective view of one embodiment of an unexpanded dual expansion anchor <NUM> comprising an anchor body <NUM> and an expander <NUM>. The anchor has a distal end <NUM> and a proximal end <NUM>.

The anchor body <NUM> has a first end <NUM> and a second end <NUM>. In some embodiments, the first end <NUM> of the anchor body <NUM> is configured for placement into a hole in a bone. In some embodiments, the anchor <NUM> is placed in the hole in the bone so that the second end <NUM> is in closer proximity to the entrance hole into the bone than the first end <NUM>. The anchor <NUM> depicted in <FIG> has a radius at the first end <NUM> of r4 and a radius at the second end <NUM> of r5. In some embodiments r4 and r5 are the same. In some embodiments, r4 and r5 are different.

Anchor <NUM> can be inserted into an anchor point with an insertion tool. In some embodiments, the second end <NUM> of the anchor body <NUM> is configured for interaction with a portion of the insertion tool to thereby allow placement of the anchor <NUM> at the anchor point. In some embodiments, the second end <NUM> of the anchor body <NUM> can be configured to abut portions of the insertion tool. The abutting interaction between the anchor body <NUM> and the insertion tool can facilitate a transfer of forces between the insertion tool and the anchor body <NUM>, which transfer of forces can facilitate anchor insertion and/or result in deployment or expansion of the anchor <NUM>.

The axial bore <NUM> can be sized and dimensioned to receive the expander <NUM>. The expander <NUM> depicted in <FIG> is partially disposed within the axial bore <NUM> of the anchor body <NUM>.

The anchor body <NUM> depicted in <FIG> has plurality of first tines <NUM> extending from a position proximal to the second end <NUM> of the anchor body <NUM> to the first end <NUM> of the anchor body <NUM>. Each of the first tines <NUM> is internally defined by the axial bore <NUM> and radially defined by a plurality of first expansion slots <NUM>. An anchor body can include any desired number of first tines <NUM> and first expansion slots <NUM>, including <NUM> or less, <NUM> or less, <NUM> or less, or two first tines <NUM> and first expansion slots <NUM>. The anchor body <NUM> depicted in <FIG> has four first tines <NUM> and four first expansion slots <NUM>.

The first tines <NUM> and first expansion slots <NUM> can be positioned at any desired radial position around the anchor body <NUM>. In some embodiments, the first tines <NUM> and first expansion slots <NUM> can be positioned at regular intervals around the anchor body <NUM>. In some embodiments, the first tines <NUM> and first expansion slots <NUM> can be irregularly positioned around the anchor body <NUM>. <FIG> depicts an embodiment of an anchor body <NUM> in which the first tines <NUM> and first expansion slots <NUM> are equiangularly positioned around the anchor body <NUM>.

Different embodiments of an anchor body <NUM> can additionally include first tines <NUM> and first expansion slots <NUM> of different lengths. In some embodiments, the first tines <NUM> and first expansion slots <NUM> of an anchor body <NUM> can have equal lengths. In some embodiments the first tines <NUM> and first expansion slots <NUM> may have different lengths. In some embodiments, the first tines <NUM> and first expansion slots <NUM> can be configured to have different lengths in that some of the first tines <NUM> may extend further from the second end <NUM> of the anchor body <NUM> toward the first end <NUM> of the anchor body <NUM> than other of the first tines <NUM>. In some embodiments, the first tines <NUM> and first expansion slots <NUM> can have different lengths in that some of the first expansion slots <NUM> can extend further from the first end <NUM> of the anchor body <NUM> toward the second end <NUM> of the anchor body <NUM> than others of the first expansion slots <NUM>. <FIG> depicts and embodiment of an anchor body <NUM> in which the first tines <NUM> and first expansion slots <NUM> have equal lengths.

The anchor body <NUM> depicted in <FIG> has plurality of second tines <NUM> extending from a position proximal to the first end <NUM> of the anchor body <NUM> toward the second end <NUM> of the anchor body <NUM>. Each of the second tines <NUM> is internally defined by the axial bore <NUM> and radially defined by a plurality of second expansion slots <NUM>. An anchor body can include any desired number of second tines <NUM> and second expansion slots <NUM>, including <NUM> or less, <NUM> or less, <NUM> or less, or two second tines <NUM> and second expansion slots <NUM>. The anchor body <NUM> depicted in <FIG> has four second tines <NUM> and four second expansion slots <NUM>.

The second tines <NUM> and second expansion slots <NUM> can be positioned at any desired radial position around the anchor body <NUM>. In some embodiments, the second tines <NUM> and second expansion slots <NUM> can be positioned at regular intervals around the anchor body <NUM>. In some embodiments, the second tines <NUM> and second expansion slots <NUM> can be irregularly positioned around the anchor body <NUM>. <FIG> depicts an embodiment of an anchor body <NUM> in which the second tines <NUM> and second expansion slots <NUM> are equiangularly positioned around the anchor body <NUM>.

Different embodiments of an anchor body <NUM> can additionally include second tines <NUM> and second expansion slots <NUM> of different lengths. In some embodiments, the second tines <NUM> and second expansion slots <NUM> of an anchor body <NUM> can have equal lengths. In some embodiments the second tines <NUM> and second expansion slots <NUM> may have different lengths. In some embodiments, the second tines <NUM> and second expansion slots <NUM> can be configured to have different lengths in that some of the second tines <NUM> may extend further from the first end <NUM> of the anchor body <NUM> toward the second end <NUM> of the anchor body <NUM> than other of the second tines <NUM>. In some embodiments, the second tines <NUM> and second expansion slots <NUM> can have different lengths in that some of the second expansion slots <NUM> can extend further from the second end <NUM> of the anchor body <NUM> toward the first end <NUM> of the anchor body <NUM> than others of the second expansion slots <NUM>. <FIG> depicts and embodiment of an anchor body <NUM> in which the second tines <NUM> and second expansion slots <NUM> have equal lengths.

Some embodiments of an anchor body <NUM> can have a first set of tines <NUM> and a second set of tines <NUM> of equal length. Some embodiments of an anchor body <NUM> can have a first set of tines <NUM> and a second set of tines <NUM> of different lengths. <FIG> depicts one embodiment of an anchor body <NUM> in which the first set of tines <NUM> is longer than the second set of tines <NUM>.

Some embodiments of an anchor body <NUM> can have first expansion slots <NUM> and second expansion slots <NUM> of equal length. Some embodiments of an anchor body <NUM> can have first expansion slots <NUM> and second expansion slots <NUM> of different lengths. <FIG> depicts one embodiment of an anchor body <NUM> in which the first expansion slots <NUM> are longer than the second expansion slots <NUM>.

The first tines <NUM> and first expansion slots <NUM> and the second tines <NUM> and second expansion slots <NUM> allow the expansion of the anchor body <NUM> when the expander <NUM> is moved longitudinally in a direction from the first end <NUM> towards the second end <NUM> of the anchor body. When the anchor <NUM> is placed within a hole in a bone, the longitudinal displacement of the expander <NUM> towards the second end <NUM> of the anchor body <NUM> results in the radial expansion of the anchor body <NUM>, and specifically results in the radial expansion of the first tines <NUM> and first expansion slots <NUM> located at the first end <NUM> of the anchor body and of the second tines <NUM> and second expansion slots <NUM> located at the second end <NUM> of the anchor body <NUM>. In some embodiments, the anchor body <NUM> can be sized and dimensioned relative to the hole in which the anchor <NUM> is placed, so that the radial expansion of the anchor body resulting from the longitudinal displacement of the expander <NUM> towards the second end <NUM> causes the first tines <NUM> and the second tines <NUM> to engage with bone surrounding the hole in which the anchor <NUM> is positioned. In some embodiments, the engagement of the bone by the first tines <NUM> and the second tines <NUM> can be facilitated by teeth <NUM> located on some or all of the first tines <NUM> and/or the second tines <NUM>. <FIG> depicts one embodiment of an anchor body <NUM> in which teeth <NUM> are located on all of the first tines <NUM> and the second tines <NUM>. In some embodiments, the teeth (or ridges) <NUM> are designed to prevent the anchor <NUM> from displacing out of the bone. In some embodiments, the teeth <NUM> are designed to stabilize the anchor <NUM> in the bone. In some embodiments, the teeth <NUM> are designed to hold the anchored tissue in proximity to the bone. In some embodiments, the teeth <NUM> are designed to perform a combination of these and other functions.

In some embodiments, the teeth <NUM> may penetrate the bone, the teeth <NUM> may partially penetrate the bone, the teeth <NUM> may form depressions in the bone, or the teeth <NUM> may deform to fit to the bone.

In some embodiments, all of the teeth <NUM> on the anchor body <NUM> are similarly sized and dimensioned. An anchor body <NUM> may also have two or more types of teeth <NUM>. Specifically, an anchor body <NUM> may have a first set of teeth located proximate to the first end <NUM> of the anchor body <NUM> on some or all of the first tines <NUM>, and a second set of teeth located proximate to the second end <NUM> of the anchor body <NUM> on some or all of the second tines <NUM>.

<FIG> depicts a perspective view of one embodiment of the dual expansion anchor <NUM> comprising an anchor body <NUM> and an expander <NUM>. The body <NUM> of the anchor <NUM> depicted in <FIG> has a first end <NUM>, a second end <NUM>, an axial bore <NUM>, first tines <NUM>, first expansion slots <NUM>, second tines <NUM>, second expansion slots <NUM>, and teeth <NUM>. As depicted in <FIG>, the expander <NUM> is completely positioned within the axial bore <NUM> of the anchor body <NUM>. With the expander <NUM> positioned completely within the axial bore <NUM> of the anchor body <NUM>, the first end <NUM> of the anchor body <NUM> has a new radius r6 and the second end <NUM> of the anchor body <NUM> has a new radius r7. The expansion of the anchor body <NUM> caused by the new positioning of the expander <NUM> results in radius r6 at the first end <NUM> of the anchor body <NUM> being larger than radius r4 at the first end <NUM> of the anchor body <NUM> as depicted in <FIG>, and in radius r7 at the second end <NUM> of the anchor body <NUM> being larger than radius r5 at the second end <NUM> of the anchor body <NUM> as depicted in <FIG>. In some embodiments r6 and r7 are the same. In some embodiments r6 and r7 are different. Additionally, while <FIG> and <FIG> depict an anchor <NUM> defined respectively by two radii r4, r5 or r6, r7, a person of skill in the art will recognize that a plurality of constant or non-constant radii can define some embodiments of an anchor <NUM>. Thus, an expanded anchor <NUM> may have uniform or non-uniform radial expansion between a first end <NUM> and a second end <NUM>.

<FIG> depicts a perspective cut-away view of the same embodiment of the dual expansion anchor <NUM> comprising an anchor body <NUM> configured for use with an expander (not shown). The body <NUM> of the anchor <NUM> depicted in <FIG> has a first end <NUM>, a second end <NUM>, an axial bore <NUM>, first tines <NUM> and first expansion slots <NUM>, second tines <NUM> and second expansion slots <NUM>. An axial bore <NUM> has a longitudinal axis <NUM> and can comprise a variety of shapes and sizes. In some embodiments, an axial bore may have a single shape and constant diameter throughout the length of the anchor body <NUM>. In some embodiments, and as depicted in <FIG>, the shape and size of the axial bore <NUM> may vary along the length of the anchor body <NUM>. A person of skill in the art will recognize that variations in the shape and size of the axial bore <NUM> can be used in connection with variations in the size and shape of the expander (not shown) to achieve desired expansion of the anchor body <NUM>, to achieve desired placement of the expander (not shown) within the anchor body <NUM>, and to facilitate and/or prevent certain movements of the expander (not shown) within the anchor body <NUM>.

As depicted in <FIG>, and axial bore <NUM> can comprise portions that are parallel to the longitudinal axis <NUM> of the axial bore <NUM>, perpendicular to the longitudinal axis <NUM> of the axial bore <NUM>, or angled relative to the longitudinal axis <NUM> of the axial bore <NUM>. The axial bore <NUM> can comprise a first sloped portion <NUM>. The first sloped portion <NUM> can be located proximate to the first end <NUM> of the anchor body <NUM>, or as depicted in <FIG>, separated from the first end <NUM> of the anchor body <NUM> by a parallel portion <NUM>, parallel to the longitudinal axis <NUM> of the axial bore <NUM>. The first sloped portion <NUM> can be configured to provide a cam surface for the expander (not shown) to facilitate movement of the expander (not shown) into the axial bore <NUM> and to thereby facilitate expansion of the radius of the first end <NUM> of the anchor body <NUM> from radius r4 to radius r6.

The axial bore <NUM> can include a first stop <NUM>. As depicted in <FIG>, a first stop <NUM> is a wall non-parallel to the longitudinal axis <NUM> of the anchor body <NUM>. As depicted in <FIG>, the first stop <NUM> can be configured to provide an engageable surface to interact with portions of the expander (not shown) and thereby prevent the expander (not shown) from retracting once the expander (not shown) has advanced past a designated point. Advantageously, prevention of the retraction of the expander (not shown) enables the permanent placement of an anchor <NUM> in bone.

A first stop can be located a desired distance from the first end <NUM> so as to achieve a desired degree of spreading of the first end <NUM> of the anchor body <NUM>. In some embodiments, the first stop <NUM> can be located so that the first end <NUM> of the anchor body <NUM> achieves an expanded radius of approximately <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeter, or any other desired diameter.

The axial bore <NUM> can comprise a second sloped portion <NUM>. As depicted in <FIG>, the second sloped portion <NUM> can be located proximate to the second end <NUM> of the anchor body <NUM>. The second sloped portion <NUM> can be configured to provide a cam surface for the expander (not shown) to facilitate movement of the expander (not shown) down the axial bore <NUM> and to thereby facilitate expansion of the radius of the second end <NUM> of the anchor body <NUM> from radius r5 to radius r7. In some embodiments, the second end <NUM> of the anchor body <NUM> achieves an expanded radius of approximately <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeters, <NUM> millimeter, or any other desired diameter.

An anchor can be used with a variety of expanders. <FIG> depicts one embodiment of an expander <NUM> comprising an expansion member <NUM> having a first end <NUM> and a second end <NUM>. An expansion member <NUM> can have one or more features configured to cause expansion of an anchor body when the expander <NUM> is longitudinally displaced into the anchor body. The expander <NUM> depicted in <FIG> has a spreading head <NUM> having a radius r8 and located proximate to the first end <NUM> of the expansion member <NUM>. The spreading head <NUM> can be manufactured to any desired size and shape. As depicted in <FIG>, spreading head <NUM> can comprise a conical frustum having a base <NUM> located at the first end <NUM> of the expander. A person of skill in the art will recognize that the shape and size of the head <NUM> will affect the ultimate degree and shape of expansion of the anchor body, as well as the requisite forces to longitudinally displace the expander <NUM> within the anchor body.

In some embodiments, an expansion member <NUM> can include a shaft <NUM> having a diameter r9. As depicted in <FIG>, shaft <NUM> can extend longitudinally from the spreading head <NUM> to the second end <NUM> of the expansion member <NUM>. Shaft <NUM> can have a variety of sizes and shapes. The shaft <NUM> depicted in <FIG> is a conical shaft. In some embodiments, the shaft <NUM> can have a diameter r9 configured to fit within the axial bore of an anchor body without causing expansion of the anchor body. Thus, in some embodiments, expander <NUM> can be non-expandingly disposed within the axial bore of the anchor body when the shaft <NUM> is located in the axial bore and features of the expansion member <NUM> configured for expanding the anchor body are positioned so as to not cause expansion of the anchor body.

In some embodiments, and as depicted in <FIG>, the shaft <NUM> can comprise a caming surface <NUM>. In some embodiments, caming surface <NUM> can, for example, facilitate placement of the expander <NUM> in an axial bore of an anchor, or facilitate the expansion of the anchor body.

In some embodiments, an expander <NUM> can include features to facilitate application of forces to the expander <NUM> to affect deployment of the anchor. In some embodiments, an expander <NUM> can comprise a threaded hole in the second end <NUM> configured for threading engagement with a threaded portion of the insertion tool. In some embodiments of an anchor in which the anchor is deployed or expanded by the proximal movement of the expander <NUM> relative to the anchor, the anchor body can abut with a portion of the insertion tool so as to prevent movement of the anchor body relative to the insertion tool. The expander <NUM> can be connected to a portion of the insertion tool that is relatively moveable as compared to the portion of the insertion tool against which the anchor body abuts. In some embodiments, the abutting interaction of the anchor body and the insertion tool, and the connection of the expander <NUM> to a relatively moveable portion of the insertion tool can allow the longitudinal displacement of the expander from a first, undeployed, unexpanded position proximate to the distal end of the anchor toward the proximate end of the anchor and to a second, deployed, expanded position.

An expander can include features configured for engaging with and capturing material to be secured to the bone, such as, for example, tissue or a suture. These features can be located on a variety of portions of the expansion member <NUM>, including, for example, the head <NUM>, shaft <NUM>, or any other feature configured for expansion. <FIG> depicts several embodiments of features configured for engaging with material to be secured to the bone, such as, for example, tissue or a suture, mounted on the base of the head of the expansion member. In some embodiments, an expander <NUM> can comprise a head <NUM> having a base <NUM>. In some embodiments, the expander <NUM> can further include a penetrating member <NUM> extending from the base <NUM> of the spreading head <NUM>. The penetrating member <NUM> can comprise a variety of sizes and shapes. As depicted in <FIG>, the penetrating member <NUM> comprises a feature having a triangular cross-section, such as, for example, a feature comprising a cone, a triangular pyramid, a square pyramid, or a rectangular pyramid. The penetrating member <NUM> can be configured for deforming the material to be secured to the bone, or for piercing a hole into or through the material to be secured to the bone.

In some embodiments, the expander <NUM> can include a first hole <NUM> and a second hole <NUM>. Holes <NUM>, <NUM> can comprise a range of sizes and shapes, and can be configured for allowing threading of the material to be secured to the bone or a securement feature, such as, for example, a suture, through the holes <NUM>, <NUM>. As also depicted in <FIG>, in some embodiments of the expander <NUM>, a suture <NUM> can pass through the first hole <NUM> and the second hole <NUM> to form a loop <NUM>, which, in combination with base <NUM> defines an encircled area <NUM> through which a tendon or other material to be secured to the bone can be passed. A tendon, or other material to be secured to the bone can be passed through the encircled area <NUM> and the ends of the suture <NUM> can be tensioned to constrict the loop <NUM> and thereby secure the material to be secured to the bone in the loop <NUM> and against the base <NUM>. The suture <NUM> can then be secured to prevent loosening of the suture <NUM> and release of the tendon or other material to be secured to the bone.

In some embodiments, the expander <NUM> can further include a loop member <NUM> extending from the base <NUM> of the spreading head <NUM>. The loop member <NUM> can comprise a variety of sizes and shapes. As depicted in <FIG>, the loop member <NUM> can comprise an elongated torus. The loop member <NUM> as depicted in <FIG> can be configured for allowing threading of the material to be secured to the bone or a securement feature, such as, for example, a suture, through the loop member <NUM>.

In some embodiments, the expander <NUM> can further include a retention penetrating member comprising a penetrating element <NUM> and a shaft element <NUM> extending from the base <NUM> of the spreading head <NUM>. The retention penetrating member can comprise a variety of sizes and shapes. As depicted in <FIG>, the retention penetrating member comprises a penetrating element <NUM> having a triangular cross-section, such as, for example, a feature comprising a cone, a triangular pyramid, a square pyramid, or a rectangular pyramid. As depicted in <FIG>, the larger size the penetrating element <NUM> as compared to the shaft element <NUM> can create a retention penetrating member capable of facilitating penetration of the material to be secured to the bone and hindering the retraction of the retention penetrating member from the material to be secured to the bone after penetration.

In some embodiments, the expander <NUM> can further include a plurality of penetrating members <NUM> extending from the base <NUM> of the spreading head <NUM>. The penetrating members <NUM> can comprise a variety of sizes and shapes. As depicted in <FIG>, the penetrating members <NUM> comprises features having a triangular cross-section, such as, for example, a feature comprising a cone, a triangular pyramid, a square pyramid, or a rectangular pyramid. In some embodiments, the penetrating members <NUM> can be each configured to create punctuate contact, linear contact, or any other type of desired contact with the material to be secured. In embodiments in which the penetrating members <NUM> are configured for punctuate contact, each of the penetrating members <NUM> can be configured to extend to a point. In embodiments in which the penetrating members <NUM> are configured for linear contact, each of the penetrating members may linearly stretch across base <NUM> of the spreading head <NUM> and extend to a linear edge. The penetrating members <NUM> can be configured for deforming the material to be secured to the bone, or for piercing a hole into or through the material to be secured to the bone.

In some embodiments, the expander <NUM> can comprise a first hole <NUM> and a second hole <NUM>, both extending through the spreading head <NUM> of the expander <NUM>, a suture <NUM> passing through the first hole <NUM> and the second hole <NUM>, and a stirrup <NUM> extending from the base <NUM> of the spreading head <NUM> of the expander <NUM>. The stirrup <NUM> can comprise a first prong <NUM> and a second prong <NUM>. In some embodiments, the stirrup <NUM> can be configured to facilitate the retention of material for securing to a bone between the first prong <NUM> and the second prong <NUM>. The stirrup <NUM>, and the first and second prongs <NUM>, <NUM> can comprise a variety of shapes and sizes, and can be made from a variety of materials.

The stirrup <NUM> can be configured for different degrees of movement relative to the anchor. In some embodiments, the stirrup <NUM> can be configured to partially fit within the anchor when the anchor is deployed, and in some embodiments, the stirrup <NUM> may be wholly outside of the anchor when the anchor is deployed. In some embodiments, the stirrup <NUM> can be static and in some embodiments, the stirrup <NUM> can be dynamic. In some specific embodiments, the first and second prongs <NUM>, <NUM> can be static and/or dynamic relative to each other.

In some embodiments, the stirrup <NUM> can further comprise a shelf <NUM>. The shelf <NUM> can extend between the first and second prongs <NUM>, <NUM>. In some embodiments, the shelf <NUM> can be configured to facilitate in bending of the material to be secured to the bone, and can advantageously prevent the material from moving relative to the shelf <NUM> while securing the material to the bone.

The shelf <NUM> can comprise a variety of shapes and sizes. In some embodiments, the shelf <NUM> can have a rectangular cross-section, a triangular cross-section, a trapezoidal cross-section, or have any other desired cross-sectional shape.

In some embodiments, the expander <NUM> can comprise a first hole <NUM> extending through the spreading head <NUM> of the expander <NUM>. The first hole <NUM> can comprise a variety of shapes and sizes, and can be located in a variety of positions on the spreading head <NUM>. As depicted, the first hole <NUM> can extend axially through the spreader head <NUM>.

In some embodiments, the expander <NUM> can further comprise a suture <NUM> extending through the first hole <NUM>. In some embodiments, the suture <NUM> can be formed into a loop <NUM> and can be manipulated into a knot <NUM>. In some embodiments, the knot <NUM> can be performed before a procedure using the expander <NUM>, and in some embodiments, the knot <NUM> can be formed during the procedure. In some embodiments, the knot <NUM> can be configured to maintain a constant size of the loop <NUM>, and in some embodiments, the knot <NUM> can be configured to allow the loop <NUM> to change size. In some embodiments, the loop <NUM> can be configured to receive and retain the material that is to be secured to the bone. Advantageously, in some embodiments, the size of the suture <NUM> and the size of the knot <NUM> can prevent the loop <NUM> of the suture <NUM> from moving through the first hole <NUM> of the expander <NUM>.

In some embodiments, the expander <NUM> can comprise a stirrup <NUM> comprising a first prong <NUM> and a second prong <NUM>, a first hole <NUM>, and a spike <NUM>. The spike <NUM> can be configured to retain material that is positioned between the first and second prongs <NUM>, <NUM>. In some embodiments, the spike <NUM> can be configured to retain the material positioned between the first and second prongs <NUM>, <NUM> by piercing that material.

The spike <NUM> can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the spike can be sized and shaped to be positionable via the first hole <NUM> between the first prong <NUM> and the second prong <NUM>.

In some embodiments, the expander can comprise a combination of the above disclosed features configured for engaging with and capturing material to be secured to the bone. Thus, in some embodiments, an expander may include, for example, one or several penetrating members and a suture or loop member. A person skilled in the art will recognize that the present disclosure contemplates a variety of different combination of features configured for engaging with and capturing material to be secured to the bone, and is not limited to the specific embodiments outlined above.

<FIG> depicts one such hybrid embodiment of an expander including multiple features configured for engaging with and capturing material to be secured to the bone. As depicted in <FIG>, expander 750b comprises a head 752b having a base 754b. The expander 750b further includes a plurality of penetrating members 796b extending from the base 754b of the spreading head 752b. As seen in <FIG>, these penetrating members 796b can comprise a variety of shapes and dimensions. As further seen in <FIG>, base 754b further comprises a first hole 766b and a second hole 768b configured to receive a suture to form suture loop 763b. A tendon, or other material to be secured to the bone can be passed through the suture loop 763b and over penetrating member 796b. Further, tension of the suture loop 763b increases the force with which the secured material contacts the penetrating members 796b, and thereby further secures the material.

<FIG> depicts one embodiment of a single piece expander <NUM> comprising and expansion member <NUM> having a first end <NUM> and a second end <NUM>. The expansion member <NUM> further comprises a spreading head <NUM> having a radius r10 and having a base <NUM>, a first shaft portion <NUM> having a radius r11, an spreading shoulder <NUM> having a radius r12, and a second shaft portion <NUM> having a radius r13. The spreading head <NUM> depicted in <FIG> comprises a conical frustum having a base at the first end <NUM> of the single piece expander <NUM>. The base <NUM> of the spreading head <NUM> depicted in <FIG>, is radially elevated above the first shaft portion <NUM>, above the spreading shoulder <NUM>, and above the second shaft portion <NUM>, in that the radius r10 of the base <NUM> of the spreading head <NUM> is larger than the radius r11 of the first shaft portion <NUM>, larger than the radius r12 of the spreading shoulder <NUM>, and larger than the radius r13 of the second shaft portion <NUM>. The spreading head <NUM> can comprise a variety of sizes and shapes and a variety of relative sizes according to application requirements for an anchor.

The expansion member <NUM> depicted in <FIG> comprises a spreading shoulder located between the first end <NUM> and the second end <NUM> of the single piece expander <NUM>. However, in other embodiments, the spreading shoulder <NUM> can be located in other positions on the single piece expander <NUM>, including, at the second end <NUM> of the single piece expander <NUM>. The spreading shoulder <NUM> depicted in <FIG> is radially elevated above the first shaft portion <NUM> and above the second shaft portion <NUM> in that the radius r12 of the spreading should <NUM> is larger than the radius r11 of the first shaft portion <NUM> and larger than the radius <NUM> of the second shaft portion <NUM>. The spreading shoulder <NUM> can comprise a variety of sizes and shapes and a variety of relative sizes according to application requirements for an anchor. In some embodiments, the spreading shoulder <NUM> can be radially smaller than, radially equal to, or radially larger than the base <NUM> of the spreading head <NUM>, than the first shaft portion <NUM>, or than the second shaft portion <NUM> Likewise, the shapes and dimensions of the other features of the single piece expander can be varied to achieve desired results.

<FIG> depicts a perspective cut-away view of an anchor <NUM> comprising an anchor body <NUM> and an expander <NUM> in an expanded or deployed configuration.

The expander depicted in <FIG> comprises an expansion member <NUM> having a first end <NUM> and a second end <NUM>. The expansion member <NUM> further comprises a spreading head <NUM> having a base <NUM> located at the first end <NUM>. The expansion member additionally comprises a caming surface <NUM> located proximate to the second end <NUM> of the expansion member <NUM> and between the first end <NUM> of the expansion member <NUM> and the second end <NUM> of the expansion member <NUM>.

The anchor body <NUM> depicted in <FIG> comprises a first end <NUM>, a second end <NUM>, an axial bore <NUM>, first tines <NUM> and first expansion slots <NUM>, second tines <NUM> and second expansion slots (not shown). The axial bore <NUM> of the anchor body <NUM> depicted in <FIG> also has a first stop <NUM> and a caming abutment <NUM>.

As depicted in <FIG>, the expander <NUM> is wholly positioned within the axial bore <NUM> of the anchor body <NUM>. Specifically, the expander <NUM> is positioned within the axial bore <NUM> of the anchor body <NUM> such that the first stop <NUM> prevents movement of the expander <NUM> towards the first end <NUM> of the anchor body <NUM> by abuttingly engaging with the base <NUM> of the spreading head <NUM> of the expander <NUM>.

As depicted in <FIG>, the spreading head <NUM> and other portions of the expander <NUM> expandingly engage with portions of the axial bore to deploy or expand the anchor body <NUM>.

<FIG> depicts one embodiment of a two piece expander <NUM> comprising a first expansion member <NUM> and a second expansion member <NUM>. In some embodiments, a two piece expander <NUM> can include features to facilitate application of forces to the expander <NUM> to affect deployment of the anchor. In some embodiments of an anchor in which the anchor is deployed, or expanded, by the movement of the expander <NUM> relative to the anchor, the anchor body can abut with a portion of the insertion tool so as to prevent movement of the anchor body relative to the insertion tool. The pieces of the expander <NUM> can be connected to one or multiple portions of the insertion tool that are relatively moveable as compared to the portion of the insertion tool against which the anchor body abuts. In some embodiments, the abutting interaction of the anchor body and the insertion tool, and the connection to the pieces of the expander <NUM> allow the relatively moveable portion of the insertion tool to longitudinally displace the expander pieces from a first, undeployed, unexpanded position to a second, deployed, expanded position.

The first expansion member has a first end <NUM> and a second end <NUM>. The first expansion member <NUM> has a first spreading head <NUM> having a base <NUM> defined by a radius r14, and a first shaft portion <NUM> defined by a radius r15. The first spreading head <NUM> depicted in <FIG> comprises a conical frustum having a base <NUM> at the first end <NUM> of the first expansion member <NUM> of the double piece expander <NUM>. The base <NUM> of the first spreading head <NUM> depicted in <FIG>, is radially elevated above the first shaft portion <NUM> in that the radius r14 of the base <NUM> of the first spreading head <NUM> is larger than the radius r15 of the first shaft portion <NUM>. The first spreading head <NUM> can comprise a variety of sizes and shapes and a variety of relative sizes according to application requirements for an anchor.

The second expansion member <NUM> has a first end <NUM> and a second end <NUM>. The second expansion member <NUM> has a second spreading head <NUM> having a base <NUM> defined by a radius r16, and a second shaft portion <NUM> defined by a radius r17. The second spreading head <NUM> depicted in <FIG> comprises a conical frustum having a base <NUM> at the first end <NUM> of the second expansion member <NUM> of the double piece expander <NUM>. The base <NUM> of the second spreading head <NUM> depicted in <FIG>, is radially elevated above the second shaft portion <NUM> in that the radius r16 of the base <NUM> of the second spreading head <NUM> is larger than the radius r17 of the second shaft portion <NUM>. The second spreading head <NUM> can comprise a variety of sizes and shapes and a variety of relative sizes according to application requirements for an anchor. The first and second spreading heads <NUM>, <NUM> can comprise a variety of sizes and shapes and a variety of relative sizes according to application requirements for an anchor. In some embodiments, the base <NUM> of the first spreading head <NUM> can be radially smaller than, radially equal to, or radially larger than the base <NUM> of the second spreading head <NUM>. Similarly, the relative sizes of the first shaft portion <NUM> and the second shaft portion <NUM> can vary with respect to each other and with respect to the first and second spreading heads <NUM>, <NUM>.

In some embodiments of a double piece expander <NUM>, the second expansion member can comprise a thru-hole <NUM>. The thru-hole can be sized and shaped to allow a portion of the insertion tool configured for attachment to the first expansion member <NUM> to pass through the second expansion member <NUM>.

In some additional embodiments, the second end <NUM> of the second expansion member <NUM> can be configured for abutting contact with a portion of an insertion tool. In some embodiments, the portion of the insertion tool can be configured to allow movement of the second expansion member <NUM> relative to the anchor body.

<FIG> depicts a perspective cut-away view of an anchor <NUM> in an expanded or deployed configuration comprising an anchor body <NUM> and a double piece expander <NUM>.

The double piece expander <NUM> depicted in <FIG> comprises a first expansion member <NUM> and a second expansion member <NUM>. The first expansion member <NUM> has a first end <NUM> and a second end <NUM> and comprises a first spreading head <NUM> having a base <NUM> located at the first end <NUM>. The second expansion member <NUM> has a first end <NUM> and a second end <NUM> and comprises a second spreading head <NUM> having a base <NUM> located at the first end <NUM>.

The anchor body <NUM> depicted in <FIG> comprises a first end <NUM>, a second end <NUM>, an axial bore <NUM>, first tines <NUM> and first expansion slots <NUM>, second tines <NUM> and second expansion slots (not shown). The axial bore <NUM> of the anchor body <NUM> depicted in <FIG> also has a first stop <NUM> and a second stop <NUM>.

As depicted in <FIG>, the expander <NUM> is wholly positioned within the axial bore <NUM> of the anchor body <NUM>. Specifically, the expander <NUM> is positioned within the axial bore <NUM> of the anchor body <NUM> such that the first stop <NUM> prevents movement of first expansion member <NUM> towards the first end <NUM> of the anchor body <NUM> by abuttingly engaging with the base <NUM> of the first spreading head <NUM> of the first expansion member <NUM>. The second expansion member <NUM> of the expander <NUM> is positioned within the axial bore <NUM> of the anchor body <NUM> such that the second stop <NUM> prevents movement of second expansion member <NUM> towards the second end <NUM> of the anchor body <NUM> by abuttingly engaging with the second spreading head <NUM> of the second expansion member <NUM>. As additionally depicted in <FIG>, the first expansion member <NUM> is not in contact with second expansion member <NUM>. However, a person of skill in the art will recognize that in some embodiments, a first expansion member <NUM> may be in contact with a second expansion member <NUM>.

As depicted in <FIG>, the first spreading head <NUM> and the second spreading head <NUM> expandingly engage with portions of the axial bore to deploy or expand the first tines <NUM> and first expansion slots <NUM> located at the first end <NUM> of the anchor body <NUM> and the second tines <NUM> and second expansion slots <NUM> located at the second end <NUM> of the anchor body <NUM> respectively.

The above described dual expansion anchor can be made from a variety of materials, including, natural, or manmade materials. The dual expansion anchor can be made of metal, plastic, polymer, composite, or other materials. In some embodiments, the anchor is made of a biocompatible polymer, plastic, or metal. 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), polyether ether ketone (PEEK), 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 one embodiment of an inserter tool. An inserter tool comprises a range of features configured to allow the inserter tool to insert an anchor and then deployingly interact with the anchor. One embodiment of an inserter tool may be configured for use with a specific anchor configuration, or with a specific spreader configuration. <FIG> depicts an embodiment of an inserter configured for use with a single piece expander. 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 anchor during manufacturing. In a preferred embodiment, the inserter tool is disposable.

The inserter tool <NUM> is designed to insert and manipulate an anchor such as the anchor described in <FIG>. In some embodiments, the anchor is manufactured to be attached to an 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. The inner rod <NUM> extends through outer tube <NUM> and is configured to attach to the expander via threading on both the proximal hole in the expander 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> depicts an embodiment of an inserter configured for use with a two piece expander. Like the inserter tool <NUM> depicted in <FIG>, inserter tool 1000a comprises an inner rod or tube 1100a, an outer tube 1200a, a handle body 1300a, a threaded actuator shaft 1400a, and a deployment knob 1500a. In some embodiments, the inner rod or tube 1100a, the outer tube 1200a, the handle body 1300a, the threaded actuator shaft 1400a, and the deployment knob 1500a of inserter tool 1000a can fit together as described in relation to those features of <FIG>. In some embodiments, some or all of the inner rod or tube 1100a, the outer tube 1200a, the handle body 1300a, the threaded actuator shaft 1400a, and the deployment knob 1500a of inserter tool 1000a can include additional features configured to facilitate use with a two piece expander. These differences can include, for example, additional features located on the outer tube 1200a, or on any other feature of the inserter tool 100a. Additional features of the outer tube 1200a will be discussed in greater detail below.

<FIG> shows a perspective view of an embodiment of the inner rod <NUM>. In some embodiments, the inner rod is an inner tube. The inner rod comprises a distal end configured to secure to the expander, 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 <NUM> 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 <NUM> of the inner rod <NUM> is configured to be advanced through the central hole in the anchor body and then secured to the expander until the anchor is fully deployed and the inner rod <NUM> is separated from the anchor. In some embodiments, the distal end <NUM> can comprise features configured to engage with the expander, such as, for example, threads <NUM>. The body <NUM> of the inner rod <NUM> is configured for sliding positioning within outer tube <NUM>.

The inner rod <NUM> extends through the central hole in the anchor body before coupling with the expander. In one embodiment, the inner rod <NUM> couples with the expander through threads on the end of the inner rod <NUM> and within the proximal end of the expander. In other embodiments, the inner rod <NUM> may couple to the expander 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 via threading <NUM>. The distal end <NUM> of the outer tube <NUM> is configured such that the inner rod is drawn into the outer tube <NUM> and through opening <NUM> in the distal end <NUM> of outer tube <NUM> where it is secured to the expander. When the inner tube is advanced far enough that the expander 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. When the inner rod withdraws further into the outer tube upon the continued rotation of the deployment knob and advancement of the actuator shaft, the inner rod strips the threading from the expander and the inserter tool detaches from the anchor.

<FIG> shows an embodiment of the outer tube 1200a configured for use with a two piece expander. The outer tube 1200a is attached at its proximal end 1205a to the distal end of handle via threading 1225a. The distal end 1210a of the outer tube 1200a is configured such that the inner rod is drawn into the outer tube 1200a and through opening 1220a of the distal end 1210a of outer tube 1200a where it is secured to the expander. In some embodiments of an outer tube 1200a configured for use with a two piece expander, the distal end 1210a of the outer tube comprises a first abutment 1212a. In some embodiments, the first abutment 1212a is configured for abutting engagement with the second end <NUM>, <NUM> of a dual expansion anchor <NUM>, <NUM>.

In some embodiments, the distal end 1210a of the outer tube 1200a comprises a first base 1260a and a first elevated abutment 1262a. In some embodiments, the first base <NUM> is sized and dimensioned to fit within portions of the axial bore <NUM>, <NUM> proximate to the second end <NUM>, <NUM> of anchor <NUM>, <NUM>. The first base 1260a can be, for example, sized and shaped to slidably enter portions of the axial bore <NUM>, <NUM> proximate to the second end <NUM>, <NUM> of the dual expansion anchor <NUM>, <NUM> when the dual expansion anchor <NUM>, <NUM> is in its deployed or expanded configuration, or, alternatively, to slidably enter portions of the axial bore <NUM>, <NUM> proximate to the second end <NUM>, <NUM> of the dual expansion anchor <NUM>, <NUM> when the dual expansion anchor <NUM>, <NUM> is in its undeployed or unexpanded configuration. In some embodiments, the first elevated abutment 1262a of the outer tube 1200a is configured for abutting engagement with the second end <NUM> of the second expansion member <NUM>.

In some embodiments, the distal end 1210a of the outer tube 1200a comprises a second base 1270a and a second elevated abutment 1272a. In some embodiments, the second base 1270a is sized and dimensioned to fit within portions of the axial bore <NUM>, <NUM> proximate to the second end <NUM>, <NUM> of anchor <NUM>, <NUM>. In some embodiments, second base 1270a is configured to slidingly extend through a thru-hole in the second expansion member <NUM>. In some embodiments, the second base 1270a can be sized and configured to extend through the second expansion member <NUM>. In some embodiments, the second base 1270a terminates at a point within the axial bore <NUM>, <NUM> of the anchor <NUM>, <NUM> where the second elevated abutment 1272a abuts the second end <NUM> of the first expansion member <NUM> when the dual expansion anchor is in its deployed or expanded configuration.

In some embodiments, the features of the distal end 1210a of the outer tube 1200a are configured to facilitate deployment of a dual expansion anchor <NUM>, <NUM> with a two piece expander <NUM>. In some embodiments, a dual expansion anchor <NUM>, <NUM> can be positioned on the distal end <NUM> of the outer tube 1200a of an inserter tool 1000a. Specifically, in some embodiments, the second expansion member <NUM> of a dual expansion anchor <NUM>, <NUM> can abut the first elevated abutment 1262a. In some embodiments, the second base 1270a and the inner tube 1100a can extend through a thru-hole in the second expansion member <NUM> of a dual expansion anchor <NUM>. In some embodiments, a second end <NUM>, <NUM> of the anchor body <NUM>, <NUM> can contact the second expansion member <NUM> of the two piece expander <NUM> and the first end <NUM>, <NUM> of the dual expansion anchor <NUM>, <NUM> can contact the first expansion member <NUM> of the two piece expander <NUM>. In some embodiments the first expansion member <NUM> of the two piece expander <NUM> can be affixed to the inner tube 1100a. When the inner tube 1100a is longitudinally displaced to expand/deploy the anchor <NUM>, <NUM>, the inner tube 1100a applies a force to the first expansion member <NUM> of the two piece expander <NUM> while the first elevated abutment 1262a applies a reactionary force to the second expansion member <NUM> of the two piece expander <NUM>. The application of these forces can displace the first and second expansion members <NUM>, <NUM> of the two piece expander <NUM> until both the first and second expansion members <NUM>, <NUM> of the two piece expander <NUM> are in their deployed position. More specifically, the first expansion member <NUM> of the two piece expander <NUM> can displace under applied forces until the first expansion member <NUM> of the two piece expander <NUM> contacts the second elevated abutment 1272a. Additionally, the second expansion member <NUM> of the two piece expander <NUM> can displace under the applied forces until second end <NUM>, <NUM> of the anchor body <NUM>, <NUM> contacts the first abutment 1212a of the distal end 1210a of the outer tube 1200a. In some embodiments, the second elevated abutment 1272a can be positioned relative to the first elevated abutment 1262a, and the dual expansion anchor <NUM>, <NUM> can be designed such that the first expansion member <NUM> of the two piece expander <NUM> only contacts the second elevated abutment 1272a after the second end <NUM>, <NUM> of the anchor body <NUM>, <NUM> contacts the first abutment 1212a of distal end 1210a of the outer tube 1200a. After both the first and second expansion members <NUM>, <NUM> of the two piece expander <NUM> reach their deployed/expanded positions, the inner tube 1100a is separated from the first expansion member <NUM> of the two piece expander <NUM>, and the connection between the inserter tool 1000a and the anchor <NUM>, <NUM> is terminated.

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

<FIG> depicts a perspective view of one embodiment of the handle portion <NUM> of a handle <NUM>. Handle portion <NUM> includes a threaded hole for threading engagement with threading <NUM> of the outer tube <NUM>. Handle portion <NUM> depicted in <FIG> further includes brace receiving openings <NUM>. Handle portion <NUM> additionally includes flat surfaces <NUM>.

<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 surfaces <NUM> of the handle <NUM> 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 expander, inner tube <NUM> and actuator <NUM> are configured to operate as one piece. The flat surfaces <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 expander is then advanced into the anchor body to expand the anchor body into bone and secure the anchor.

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 is deployed and locked into place.

<FIG> shows one embodiment of a dual expansion anchor <NUM> coupled to the inserter tool <NUM> and <FIG> shows one embodiment of a dual expansion anchor <NUM> coupled to the inserter tool <NUM>. The anchors comprise the anchor body <NUM>, <NUM> and the expander <NUM>, <NUM>. Expander <NUM> depicted in <FIG> includes a penetrating member <NUM> for securing the anchored material. Expander <NUM> as depicted in <FIG> includes a suture <NUM> passing through holes <NUM>, <NUM> in the expander <NUM> and forming a loop <NUM> for securing the anchored material. A person of skill in the art will recognize that any of the above disclosed, or other features configured for engaging with and capturing material to be secured to the bone can be used in connection with a dual expansion anchor <NUM>, <NUM> coupled to an inserter tool <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>, <NUM>. The outer tube <NUM> may hold the anchor body <NUM>, <NUM> steady during insertion and deployment. The inner rod <NUM> extends through the anchor body <NUM>, <NUM> and couples with the expander <NUM>, <NUM> via threading. The expander <NUM>, <NUM> is configured to be advanced through the distal end of the anchor body <NUM>, <NUM> by the inner rod <NUM> via a rotating the deployment knob <NUM>.

In another embodiment, the inner rod <NUM> extends through the expander <NUM>, <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>, <NUM> is fully deployed.

The inner rod <NUM> provides the mechanism to draw the expander <NUM>, <NUM> into the central bore <NUM>, <NUM> in the anchor body <NUM>, <NUM> to fully expand the anchor body <NUM>, <NUM>. During deployment of the tissue capture anchor <NUM>, <NUM>, the inner rod <NUM> is continually advanced via a screwing motion until the expander 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 expander <NUM>, <NUM>, the inner rod <NUM> strips the threads from the inside of the expander <NUM>, <NUM> and the insertion tool <NUM> releases from the anchor body <NUM>, <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 expander <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 expander <NUM> via threading. The expander <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 expander <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 expander 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 expander <NUM>, the inner rod <NUM> strips the threads from the inside of the expander <NUM> and the insertion tool <NUM> releases from the anchor body <NUM>. Any thread shavings are contained within the outer tube <NUM>.

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 dual expansion anchor <NUM>, <NUM> described herein.

Although a particular inserter device for inserting and manipulating dual expansion anchor <NUM>, <NUM> has been described, it should be understood that other inserter designs may be used for manipulating the parts of dual expansion anchor <NUM>, <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 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.

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 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 j oint.

A biceps tenodesis is often, but not always, performed in patients with significant biceps tendon symptoms, and evidence at the time of viewing 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 one method, the procedure is performed arthroscopically. In one embodiment, the procedure is performed non-arthroscopically. In one embodiment, for example, a percutaneous approach may be used. In one embodiment, a <NUM> 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>, as shown in <FIG>, using a drill bit or suitably sized awl. 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, from <NUM> to <NUM> wide, or any other desired range. 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, approximately <NUM> deep, approximately <NUM> deep, or any other desired depth. 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. Angled protrusions or teeth may be used that provide greater resistance to removal of the anchor body <NUM>, <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 including those associated with the different expander types of <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.

In some exemplary embodiments, 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 some embodiments, the hole can be located in other portions of the bone. In one exemplary embodiment, the hole may be placed, approximately, <NUM> distal to the end of the bicipital groove.

In another embodiment, anchors as described above 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 including those associated with the different expander types of <FIG>.

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 secure 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.

It will be appreciated by those of skill in the art that the tissue capture anchor <NUM>, <NUM> and inserter tool <NUM> provide a system for easy attachment of a tendon or tissue to bone. The anchor <NUM>, <NUM> may be inserted into bone with minimal disruption of surrounding tissue. Only an access route having the diameter of the outer tube <NUM> and the anchor body <NUM>, <NUM> is required. Furthermore, the anchor can be securely attached to the bone without having to insert additional instrumentation into the site or without performing any cumbersome attachment maneuvers such as knot tying.

In another embodiment, anchors as described above are used for other procedures in the knee such as, for example, patellofemoral ligament reconstruction, posterolateral corner reconstruction, and tibial anchor back-up for an ACL procedure.

In some embodiments, anchors as described above can be used for numerous tissue fixation procedures in foot and ankle. These include flexor hallucis longus transfer to Achilles for loss of Achilles mechanism; posterior tibial tendon to anterior midfoot (middle cuneiform) also known as bridle/modified bridle procedure for foot drop; Lateral ligament reconstruction with allograft (potentially as primary with Brostrom-Gould type procedure) for ankle instability or non-anatomic lateral ligament reconstruction using split peroneus brevis; deltoid ligament reconstruction with allograft (for deltoid insufficiency); flexor digitorum longus or flexor hallucis longus transfer to peroneal for non-reconstructable peroneal tendon tears and reconstruction of torn tibialis anterior with extensor hallucis longus tendon transfer.

Claim 1:
A bone anchor (<NUM>), comprising: a bone engaging member (<NUM>, <NUM>, <NUM>) comprising:
a first proximal bone engaging portion (120b, <NUM>, <NUM>) and a second distal bone engaging portion (120a, <NUM>, <NUM>); and
an expansion feature configured to allow radial expansion of the first bone engaging portion (120b, <NUM>, <NUM>) and the second bone engaging portion (120a, <NUM>, <NUM>);
a two-piece expander (<NUM>) having a first proximal expansion portion (<NUM>) and a separable, second distal expansion portion (<NUM>);
wherein the two-piece expander (<NUM>) is displaceable between a first position relative to the bone engaging member (<NUM>, <NUM>, <NUM>) and a second position relative to the bone engaging member (<NUM>, <NUM>, <NUM>);
wherein the second distal expansion (<NUM>) portion has a most distal end with a first diameter and a most proximal end with a second diameter;
a tissue capture feature; and
wherein the first expansion portion (<NUM>) of the expander (<NUM>) is configured to expand the first bone engaging portion (120b, <NUM>, <NUM>) of the bone engaging member (<NUM>, <NUM>, <NUM>) and the second expansion portion (<NUM>) of the expander (<NUM>) is configured to expand the second bone engaging portion (120a, <NUM>, <NUM>) of the bone engaging member (<NUM>, <NUM>, <NUM>) when the expander (<NUM>) is in the second position;
characterized in that the first diameter is larger than the second diameter.