Patent Description:
Disorders of the long head of the biceps tendon are a common source of shoulder pain and may occur in association with other diagnoses such as rotator cuff tears, superior labrum anterior posterior tears, impingement syndrome and capsular injuries, or may be present as an isolated source of shoulder pain. The treatment options for disorders of the long head of the biceps (LHB) continue to evolve and can include LHB tenodesis. In a tenodesis procedure, a suture is passed through the base of the LHB to locate the LHB in the subacromial space and to provide proximal control during the dissection. Once the suture is placed, the LHB is cut near the glenoid attachment. A sizer can be used to measure the tendon size and to thereby determine the appropriately sized bone screw. Once the screw is selected, a bone hole is drilled and a tendon fork is then used to push the tendon down into the bone hole. A bone screw is then delivered into the bone hole to anchor the tendon within the bone hole.

While current procedures can provide an effective means for anchoring a tendon to bone, they can suffer from several drawbacks. For example, current procedures require the use of numerous tools, which can lead to a prolonged procedure and increased costs. The use of a screw can also increase the risk of damage to the tendon, as rotation of the screw into the bone hole can tear or sever through the tendon. Moreover, it can be difficult to maintain the desired tension on the tendon while the screw is being implanted, as the tendon can become misaligned and or can slip during insertion of the screw. Any tension applied to the tendon during insertion of the anchor can also cause the anchor to back-out of the bone hole.

Accordingly, there remains a need for improved methods and devices for anchoring tissue to bone, and in particular for performing a biceps tenodesis.

<CIT> discusses a solid, monolithic shaft member which has an engagement end. <CIT> relates to a delivery device including a generally tubular structure adapted to engage a facet joint, an implant adapted to be delivered through the delivery device and into the facet joint.

Various implants, tools are provided for attaching a tendon to bone. The present invention is as set forth in the appended claims. In one embodiment, an anchor assembly is provided and includes a sheath having a first sidewall with proximal and distal ends and a second sidewall with proximal and distal ends. The distal ends of the first and second sidewalls can be coupled to one another by a hinge pin such that the first and second sidewalls pivot relative to one another about the hinge pin. The anchor assembly can also include an expander having a generally elongate cylindrical configuration. The expander can be configured to be received between the first and second sidewalls of the sheath to cause the first and second sidewalls to pivot about the hinge pin and move laterally away from one another.

While the sheath can have a variety of configurations, in one embodiment each of the first and second sidewalls can have a substantially rectangular shape with a hemi-cylindrical cavity formed on one side thereof for seating the expander. The sheath can include first and second tabs on the first and second sidewalls. The first and second tabs can be positioned at a substantial mid-portion of the first and second sidewalls between the proximal and distal ends, and the first and second tabs can be configured to receive a portion of a tool therebetween when the proximal ends of the first and second sidewalls are positioned adjacent to one another.

In other aspects, the proximal end of each of the first and second sidewalls can include a boss formed thereon and configured to engage threads on the expander to maintain alignment between the sheath and the expander. The boss on each sidewall can extend toward the other one of the first and second sidewalls such that the proximal ends of the first and second sidewalls substantially circumferentially surround the expander.

In another embodiment, the first and second sidewalls can each have an internal surface facing one another and an opposite external surface, and the external surface of each of the first and second sidewalls can have ribs formed thereon. The ribs can extend substantially perpendicular to a longitudinal axis running extending in a proximal-distal direction. In an exemplary embodiment, an external surface of each of the first and second sidewalls has a plurality of rows of ribs arranged in at least on column, each rib extending substantially perpendicular to a longitudinal axis extending in a proximal-distal direction. At least one of the ribs in a proximal-most row of ribs can have a height that is greater than a height of the ribs in the rows distal of the proximal-most row.

In other aspects, each of the first and second sidewalls can have at least one protrusion with a bore formed therein and having the hinge pin extending therethrough. For example, the distal end of the first sidewall can have a first protrusion having a bore formed therein with the hinge pin extending therethrough and a second protrusion having a bore formed therein with the hinge pin extending therethrough, and the second sidewall can have a third protrusion having a bore formed therein with the hinge pin extending therethrough and a fourth protrusion having a bore formed with the hinge pin extending therethrough. In certain aspects, the third protrusion can be positioned between the first and second protrusions, and the second protrusion can be positioned between the third and fourth protrusions.

In another embodiment, at least one of the first and second sidewalls can include a proximal tab extending radially outward from the sidewall such that the tab is effective to limit an insertion depth of the sheath into a bone hole.

At least one of the first and second sidewalls can include a suture-receiving tab formed thereon and defining a suture-receiving opening extending therethrough. In certain aspects, the suture-receiving tab can extend substantially perpendicular to a longitudinal axis of the sheath such that suture-receiving opening has a central axis that extends substantially parallel to the longitudinal axis of the sheath.

In another embodiment, a bone anchor inserter tool is provided and includes an elongate shaft having proximal and distal ends and an inner lumen extending therethrough. The distal end has first and second prongs extending distally therefrom and positioned on opposite sides of the shaft. Each prong has a first pair of bosses positioned adjacent a proximal end of each prong and a second pair of bosses positioned at adjacent a mid-portion of each prong. In one embodiment, the first pair of bosses can extend radially outward from each prong by a first distance and the second pair of bosses can extend radially outward from each prong by a second distance that is less than the first distance. Each prong can have a concave inner surface. The tool can also include other features. For example, the elongate shaft can include at least one viewing window formed in a sidewall thereof at a location proximal to the first and second prongs to allow viewing into the inner lumen of the elongate shaft.

A tendon anchoring system is also provided and in one embodiment the system includes an anchor assembly having a sheath with first and second sidewalls that are coupled at a distal end by a hinge pin such that the first and second sidewalls are configured to pivot about the hinge pin relative to one another. Each sidewall can have an anti-rotation boss formed thereon. The system can also include an inserter tool having an elongate shaft with an inner lumen extending therethrough between proximal and distal ends. The distal end can have first and second prongs extending distally therefrom from opposite sides thereof and configured to extend along opposed sides of the first and second sidewalls of the sheath such that the first and second prongs are engaged between the anti-rotation boss on each sidewall to prevent rotation of the sheath relative to the first and second prongs.

Each sidewall can include a retention boss positioned proximal of the anti-rotation boss and configured to engage an expander positioned between the first and second sidewalls of the anchor assembly. The first and second prongs can each include a proximal boss positioned proximal of the retention boss on the first and second sidewalls, and a distal boss positioned proximal of the anti-rotation boss on the first and second sidewalls and distal of the retention boss on the first and second sidewalls.

The system can also include an expander having a generally elongate cylindrical configuration and configured to be received between the first and second sidewalls of the sheath to cause the first and second sidewalls to pivot about the hinge pin and move laterally away from one another.

In other aspects, a proximal end of at least one of the first and second sidewalls has a tab extending radially outward therefrom. The tab can be received within a slot in the distal end of the elongate shaft of the inserter tool to facilitate engagement between the sheath and the inserter tool.

In another embodiment, a bone anchoring system is provided and includes a sheath having a first sidewall with proximal and distal ends and a second sidewall with proximal and distal ends. The distal ends of the first and second sidewalls are coupled to one another by a hinge pin such that the first and second sidewalls pivot relative to one another about the hinge pin. The system also includes an elongate shaft having a distal end with a distally-extending central protrusion that extends into the sheath between the first and second sidewalls. The distal end has at least first and second distally-extending side protrusions positioned on opposite sides of the central protrusion and extending along opposite outer sides of the first and second sidewalls such that the first and second distally-extending side protrusions prevent rotation of the first and second sidewalls about the hinge pin.

In one embodiment, the distally-extending central protrusion extends a distance beyond the first and second distally-extending side protrusions. In other aspects, the distally-extending central protrusion and the first and second distally-extending side protrusions define a radially extending slot therebetween that seats a proximal-most end of the first and second sidewalls. The distally-extending central protrusion can have an oblong cross-sectional shape such that the distally-extending central protrusion is prevented from rotating within the first and second sidewalls.

The elongate shaft can also include third and fourth distally-extending side protrusions positioned on opposite sides of the central protrusion and extending along opposite outer sides of the first and second sidewalls. In certain aspects, the first and second outer sidewalls each have a plurality of teeth formed thereon, and the first and third distally-extending side protrusions are positioned on opposite sides of a tooth formed on an outer surface of the first sidewall, and the second and fourth distally-extending side protrusions are positioned on opposite sides of a tooth formed on an outer surface of the second sidewall.

The elongate shaft can also include a handle slidably coupled to a proximal end of the elongate shaft. In one embodiment, the elongate shaft has proximal and distal components that are rotatably coupled to one another, and the proximal component is mated to a handle.

In yet another embodiment, a bone anchor inserter tool is provided and includes an outer shaft having proximal and distal ends and an inner lumen extending at least partially therethrough. The distal end has first and second prongs extending distally therefrom. The tool also includes an inner shaft extending through the inner lumen of the outer shaft. At least a portion of the inner shaft can be non-rotatably and freely slidably coupled to the outer shaft, and the inner shaft can have a distal end with a distally-extending central protrusion and at least first and second distally-extending side protrusions positioned on opposite sides of the central protrusion.

In one embodiment, the inner shaft can include a distal component that is non-rotatable relative to the outer shaft, and a proximal component that is rotatably coupled to the distal component. The proximal and distal components of the inner shaft can be mated by a snap-fit connection. The tool can also include a handle coupled to the proximal end of the outer shaft and coupled to the proximal component of the inner shaft. In other aspects, the inner shaft can include third and fourth distally-extending side protrusions positioned on opposite sides of the central protrusion.

A tendon anchoring system is also provided and in one embodiment the system includes an anchor assembly having a sheath with first and second sidewalls that are coupled at a distal end by a hinge pin such that the first and second sidewalls are configured to pivot about the hinge pin relative to one another. The system also includes an inserter tool having an outer shaft with an inner lumen extending therethrough between proximal and distal ends thereof. The distal end can have first and second prongs extending distally therefrom. The inserter tool also includes an inner shaft extending through the inner lumen of the outer shaft and having a distal end configured to engage the first and second sidewalls of the sheath to prevent pivotal movement of the first and second sidewalls about the hinge pin.

The anchor assembly can also include an expander configured to be received within the sheath to cause the first and second sidewalls to pivot away from one another. In one embodiment, the first and second sidewalls each have at least one retention boss formed thereon and configured to engage a proximal end of the expander when the expander is seated between the first and second sidewalls. In other aspects, the expander can have an inner lumen extending therethrough with a cross-bar extending across the inner lumen for receiving a suture therearound.

The sidewalls can have a variety of configurations. The first and second sidewalls can each include at least one anti-rotation boss formed thereon and configured to engage at least one of the first and second prongs therebetween to prevent rotation of the sheath relative to the outer shaft. In other aspects, the first and second prongs can include proximal slots formed therein that receive tabs formed on the proximal ends of the first and second sidewalls of the sheath. The tabs can be configured to slide out of the slots when the first and second sidewalls of the sheath pivotally move away from one another.

Surgical methods, whilst not encompassed by the wording of the claims, are considered as useful for understanding the invention. In one embodiment the method can include advancing a sheath into a bone hole, and advancing an expander into the sheath, the expander causing first and second sidewalls of the sheath to pivot relative to one another about a hinge pin coupling distal ends of the first and second sidewalls. Advancing the sheath can include, for example, manipulating an inserter tool having the sheath mounted on a distal end thereof to advance the sheath into a bone hole. In one aspect, the inserter tool can have first and second prongs that extend between the first and second sidewalls of the sheath, and the first and second prongs can include anti-rotation bosses thereon that prevent rotation of the sheath relative to the first and second prongs during advancement of the sheath into the bone hole. In another aspect, the inserter tool can include an outer shaft and an inner shaft. The inner shaft can have a distally-extending central protrusion that extends into the sheath between the first and second sidewalls, and at least first and second distally-extending side protrusions positioned on opposite sides of the central protrusion and extending along opposite outer sides of the first and second sidewalls such that the first and second distally-extending side protrusions prevent rotation of the first and second sidewalls of the sheath about the hinge pin.

The embodiments described above will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. The drawings are not intended to be drawn to scale. In the drawings:.

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

Reference throughout the specification to "various embodiments," "some embodiments," "one embodiment," or "an embodiment", or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in various embodiments," "in some embodiments," "in one embodiment," or "in an embodiment", or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.

It will be appreciated that the terms "proximal" and "distal" may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient. The term "proximal" refers to the portion of the instrument closest to the clinician and the term "distal" refers to the portion located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.

In general, methods and devices are provided for anchoring a ligament or tendon to bone. In an exemplary embodiment, the methods and devices are used to perform a biceps tenodesis surgery, however, a person skilled in the art will appreciate that the devices and methods can be used in various procedures and for anchoring any tissue to bone. In exemplary embodiments, various inserter tools are provided for delivering various bone anchors including an expandable sheath and an expander into a bone hole to anchor a tendon or other issue within the bone hole. The sheath can be anchored without rotating the sheath, which can eliminate or reduce a possibility of undesirable twisting of the tendon.

<FIG> illustrates one embodiment of a biceps tenodesis system <NUM> that includes a sheath inserter tool <NUM> having an expandable sheath <NUM> coupled thereto, and an expander inserter tool <NUM> having an expander <NUM> coupled thereto. The sheath inserter tool <NUM> has an outer shaft <NUM>, an inner shaft <NUM>, and a handle <NUM> coupled to proximal ends of the outer and inner shafts <NUM>, <NUM>. The sheath inserter tool <NUM> is configured to advance the expandable sheath <NUM>, with a tendon disposed therearound, into a bone hole, and the expander inserter tool <NUM> is configured to advance the expander <NUM> through the outer shaft <NUM> of the sheath inserter tool <NUM> and to drive the expander <NUM> into the sheath <NUM>. The expander <NUM> is configured to be received within a lumen extending at least partially through the expandable sheath <NUM> to thereby expand the sheath <NUM>. In this way, the system <NUM> delivers the tendon or ligament into the bone hole and locks the sheath <NUM> and tendon within the bone hole. A person skilled in the art will appreciate that each of the components of the system <NUM> can have a variety of configurations and thus various expandable sheaths, expanders, sheath inserter tools, and expander inserter tools are disclosed herein, each of which can be used interchangeably with any of the other components disclosed herein.

<FIG> illustrate the sheath <NUM> of <FIG> in more detail. In general, the sheath is configured to seat a tendon therearound, and to receive the expander <NUM> therein, which is effective to cause the sheath to expand into bone to anchor the tendon within a bone hole. The sheath can be formed from any bio-compatible material, and, in some embodiments, it can be bio-absorbable. The shape and configuration of the sheath can vary. By way of example, the sheath <NUM> can be configured as described at least in <CIT>, and in <CIT>, entitled "Biceps Repair Device,".

In general, the sheath <NUM> has an elongate substantially rectangular shape, with a length extending between a proximal end 200p and a distal end 200d that is greater than a width extending between opposing sides. The sheath <NUM> is configured to move from a collapsed position to an expanded position in which the sheath has more of a cylindrical configuration for conforming to the cylindrical shape of a bone hole. In this embodiment, the sheath <NUM> is a split sheath, with first and second separate and distinct sidewalls <NUM>, <NUM> that are connected at the distal end 200d. Each sidewall <NUM>, <NUM> can have a substantially rectangular shape with an outer bone engaging surface and an inner surface configured to mate with the expander <NUM>. The sidewalls <NUM>, <NUM> can define an inner lumen <NUM> therebetween as well as slots 200a, 200b extending along opposite sides thereof adjacent to the edges of each sidewall <NUM>, <NUM>.

In the illustrated embodiment, the outer surface of each sidewall <NUM>, <NUM> has a substantially convex shape with a plurality of bone engaging surface features formed thereon. While the surface features can have a variety of shapes and sizes, in the illustrated embodiment the surface features are in the form of ribs or teeth <NUM> that are aligned in columns between the proximal and distal ends 200p, 200d as well as in rows between the opposed sides. In particular, the illustrated sidewalls <NUM>, <NUM> each have three columns of teeth arranged in five rows. A person skilled in the art will appreciate that each sidewall <NUM>, <NUM> can include any numbers of rows and columns of teeth, such as two or more columns and any number of rows which can vary based on the length of the sidewall. While each row can include a single elongate rib, providing multiple ribs in a single row (and thus providing multiple columns) can increase the flexibility of the sidewall <NUM>, <NUM>, allowing each sidewall to more readily deform against an inner surface of a bone hole. Moreover, the one or more longitudinal gaps formed between each column can help prevent damage to the tendon. The space in between the columns can provide an area for the tendon to deform into, thus preventing the tendon from being entirely pinched by the ribs.

Each tooth can have a variety of configurations. In the illustrated embodiment, each tooth is generally rectangular with four sides and a top surface that is substantially planar. The teeth <NUM> can all have substantially the same height such that the top surfaces all reside in the same plane. However, in one embodiment one or more of the proximal-most teeth can differ from the remainder of the teeth. For example, the proximal-most central tooth 208c can have a height that is greater than the height of the remainder of the teeth. Such a configuration can facilitate engagement with the bone hole to prevent sheath back-out. Such a configuration can also help prevent intra-operative or post-operative push-in of the implant further into the bone hole, especially where a modicum of cancellous bone exists. One or more of the teeth nearest the proximal end can also include ridges formed on the top surface thereof to further facilitate engagement with bone. For example, each tooth in the top row of teeth, including central tooth 208c, is shown having three ridges formed thereon. A person skilled in the art will appreciate that the teeth can have a variety of configurations and that in other embodiments the sidewalls <NUM>, <NUM> can have threads or any other bone engaging surface features formed thereon.

The inner surface of each sidewall <NUM>, <NUM> can also have a variety of configurations, but it is preferably configured to receive the expander <NUM> therein. In the illustrated embodiment, the inner surface of each sidewall <NUM>, <NUM> has a substantially concave configuration with threads <NUM> formed therein for mating with corresponding threads formed on the expander <NUM>. In this way, when the expander <NUM> is threaded into the sheath <NUM>, the expander <NUM> will engage the threads <NUM> in the sheath <NUM> to prevent the expander <NUM> from backing out of the sheath <NUM>.

As indicated above, the first and second sidewalls <NUM>, <NUM> are connected at their distal ends. In the illustrated embodiment, the sidewalls <NUM>, <NUM> are connected by a hinge such that the sidewalls <NUM>, <NUM> are pivotably movable relative to one another. As a result, the sidewalls <NUM>, <NUM> can be moved away from one another at the proximal end 200p of the sheath <NUM> when the expander <NUM> is received therein. The hinged connection at the distal end 200d of the sheath <NUM> can be achieved using a variety of techniques. As shown in <FIG>, the distal end of each sidewall <NUM>, <NUM> has a bore 202bg, 204b formed therein and extending across the sidewall <NUM>, <NUM>. The distal end of each sidewall <NUM>, <NUM> also includes gaps or cutout regions 202c, 204c formed therein and offset from the other sidewall <NUM>, <NUM> such that each sidewall <NUM>, <NUM> has two cylindrical protrusions 212a, 212b, 214a, 214b, each having a bore formed therethrough. The two cylindrical protrusions 212a, 212b on one sidewall <NUM> are received between the two cylindrical protrusions 214a, 214b on the other sidewall <NUM> so as to align all of the bores 202b, 204b and form a single bore, as shown in <FIG>, for receiving a single hinge pin <NUM> therethrough.

The hinge pin <NUM>, also shown in <FIG>, is in the form of a generally elongate cylindrical member having a head <NUM> at one end and opposed spring arms 226a, 226b at the opposite end. The spring arms 226a, 226b are formed by a cutout <NUM> extending partially into the end of the hinge pin <NUM>. Each spring arm 226a, 226b includes a flange 228a, 228b formed around an external surface thereof. In use, the hinge pin <NUM> can be passed through the bore 202b, 204b formed in the protrusions at the distal end of the sidewalls <NUM>, <NUM>. The spring arms 226a, 226b will deflect inward while being passed through the bore, and once the flange 228a, 228b on each spring arm 226a, 226b exits the opposite side of the bore, the spring arms 226a, 226b will deflect outward returning to their resting position in which the flange 228a, 228b on each spring arm 226a, 226b will engage the end surface of protrusion 212a on sidewall <NUM> (or protrusion 214b on sidewall <NUM>) so as to prevent removal of the hinge pin <NUM> from the sidewalls <NUM>, <NUM>. The hinge pin <NUM> is thus fixed within the bore and is not removable. The sidewalls <NUM>, 204are free to pivot about the hinge pin <NUM>.

The sheath <NUM> can also include other features formed thereon or therein to facilitate engagement with the bone, the expander <NUM>, or the various tools used therewith. For example, in one embodiment the sidewalls can each include one or more tabs extending outward from opposite sides thereof to engage the prongs on the inserter tool therebetween and thereby prevent rotation of the sheath relative to the tool, which will be discussed in more detail below. As shown in <FIG>, each sidewall <NUM>, <NUM> of the sheath <NUM> includes left and right proximal or upper tabs 216a, 216b, 216c, 216d (only tabs 216a, 216b are shown in <FIG>) extending radially outward from opposite sides of a proximal end 200p of the sheath <NUM>, as well as left and right distal or lower tabs 218a, 218b, 218c, 218d (only tabs 218a, 218b are shown in <FIG>) extending radially outward from opposite sides of a mid- or distal-portion of each sidewall <NUM>, <NUM>. Each of the illustrated tabs has a substantially rectangular configuration, however the tabs can have a variety of shapes and sizes.

The proximal or upper tabs 216a, 216b, 216c, 216d and the distal or lower tabs 218a, 218b, 218c, 218d can function as anti-rotation tabs. For example, the prongs of the inserter tool <NUM> (discussed below) can extend between the tabs on sidewall <NUM> and the tabs on sidewall <NUM> such that the tabs engage the prongs therebetween. As a result, the entire sheath <NUM> is prevented from rotating about an axis that extends between the sidewalls <NUM>, <NUM> and perpendicular to the longitudinal axis of the sheath.

The upper tabs 216a, 216b, 216c, 216d and the lower tabs 218a, 218b, 218c, 218d can also maintain the position of the sheath <NUM> on the distal end of the sheath inserter tool <NUM>. As will be discussed in more detail below, since a feature on the prongs extends between the upper and lower tabs 216a-d, 218a-d on the sheath <NUM>, the position of the sheath <NUM> with respect to the prongs on the sheath inserter tool <NUM> is fixed.

The upper tabs 216a, 216b, 216c, 216d can also be used to advance the sheath into a bone hole, or to maintain the sheath within the bone hole during insertion of the expander into the sheath. For example, with particularly thick tendon, the tendon may apply a proximal force to the sheath. It may be desirable to apply a distal force to the tool, which in turn acts on the upper tabs, to hold the sheath in place or to advance the sheath into the bone hole.

As best shown in <FIG> and <FIG>, each sidewall <NUM>, <NUM> can also include a retention boss 219a, 219b formed on at least one side of the proximal end thereof. Each retention boss 219a, 219b can be in the form of a protrusion extending circumferentially from the terminal end of the sidewall <NUM>, <NUM> such that the protrusion forms an extension of the proximal-most thread on each sidewall <NUM>, <NUM>. Each retention boss 219a, 219b will thus extend partially around the expander <NUM> to circumferentially engage the expander to maintain contact with the expander once the sheath <NUM> and expander <NUM> are implanted. Such a configuration can reduce the risk of expander dislodgment post-operatively. As shown in <FIG> and <FIG>, in order to accommodate the retention boss (only 219b is shown), one of the side teeth in the proximal-most row of teeth can include a notch or cut-out <NUM> formed therein for allowing the retention boss to extend therethrough.

A person skilled in the art will appreciate that the sheath <NUM> can additionally or alternatively include any other suitable features. For example, the sheath <NUM> can include anticollapse tabs or depth-stop tabs, discussed in more detail in <CIT>.

By way of non-limiting example, <FIG> illustrates sheath <NUM>', which is similar to sheath <NUM> but that includes depth-stop tabs 221a', 221b' formed thereon adjacent to the retention bosses 219a', 219b'. The depth-stop tabs 221a', 221b' extend outward from the sheath on opposed sides thereof such that they extend beyond the largest width of each sidewall of the sheath. As a result, when the sheath is inserted into a bone hole having substantially the same diameter as the sheath, the depth-stop tabs 221a', 221b' will abut against a proximal surface of the bone to prevent further insertion of the sheath into the bone hole. Such a configuration can be particularly advantageous with certain types of bone wherein it is desired to prevent the sheath from falling into the bone hole. For example, the use of a sheath having depth-stop tabs 221a', 221b' can be particularly advantageous in sub-pectoral locations since visibility can be particularly difficult.

<FIG> illustrates another embodiment of a sheath <NUM>" which is also similar to sheath <NUM>, but that includes a suture-receiving tab <NUM>" formed thereon. As shown, the tab <NUM>" is in the form of a u-shaped member that extends across one of the sidewalls, e.g., sidewall <NUM>", and that is located along a mid-portion of the sidewall <NUM>" adjacent to a distal end 200d" of the sidewall <NUM>". While only one tab <NUM>" is shown on one of the sidewalls <NUM>", a person skilled in the art will appreciate that the other sidewall, e.g., sidewall <NUM>", may or may not have a suture-receiving tab <NUM>" formed thereon. As a result of the orientation of the tab <NUM>", the opening <NUM>" of the tab will extend in a proximal-distal direction so as to allow a suture coupled to a tendon located distal of the sheath <NUM>" to be advanced through the tab <NUM>" from the distal end toward the proximal end. The trailing ends of the suture extending proximally from the tab <NUM>" can be used to tension the tendon to pull the tendon toward the sheath <NUM>". The trailing ends of the suture can also be wrapped around a portion of the sheath inserter tool, as discussed below, to maintain the sheath <NUM>" on the distal end of the inserter tool. A person skilled in the art will appreciate that the suture-receiving tabs <NUM>" can have a variety of shapes and sizes, and that various other suture-receiving features can be formed on the sheath at various locations.

As indicated above, the sheath <NUM> is configured to receive an expander that is effective to expand the sheath <NUM> to anchor the sheath <NUM> and tendon coupled thereto within a bone hole. As shown in <FIG>, in one embodiment, the expander <NUM> is in the form of a threaded member or screw having a generally cylindrical shape that tapers distally inward to a reduced diameter along at least a distal portion of the length thereof. Preferably, the taper is minor along a majority of the length so that the expander <NUM> causes slow expansion of the sheath as it is inserted therein. The expander <NUM> has a thread <NUM> formed on the outer surface thereof and extending along the entire length of the expander <NUM> to facilitate engagement with the sheath <NUM>.

The expander <NUM> can be fully cannulated so that it has a bore or inner lumen <NUM> therein. The inner lumen <NUM>, or at least a proximal portion thereof, can have a shape and size corresponding to a shape and size of a drive feature configured to be received within the inner lumen <NUM> so as to rotate the expander <NUM>. In the illustrated embodiment, the inner lumen <NUM> is in the form of a hexagonal drive socket configured to receive a hexagonal distal portion of the expander inserter tool, discussed below. The hexagonal distal portion of the expander inserter tool can be inserted into the inner lumen <NUM> as to extend along a substantial portion of the entire length of the lumen <NUM>. A person skilled in the art will appreciate, however, that other configurations of the inner lumen <NUM> can be used.

As further shown in <FIG>, the expander <NUM> can have a flat proximal facing surface <NUM> and a flat distal facing surface <NUM>. The proximal surface <NUM> and the distal surface <NUM>, however, can have various shapes and the shape can be configured to conform to the sheath and/or the bone surface. A length of the expander <NUM> can be less than, equal to, or greater than the length of the sheath <NUM>.

The expander <NUM> can also include features to allow for receipt of a suture. For example, as shown in <FIG>, the expander <NUM> includes a suture receiving bar or post-<NUM> extending thereacross for receiving a suture there around. The post can be located anywhere along the length of the expander <NUM> between the proximal and distal ends thereof, and it can extend at any angle. In the illustrated embodiment, the post <NUM> extends substantially perpendicular to a longitudinal axis of the expander <NUM>.

A person skilled in the art will appreciate that the expander can have a variety of other configurations, and the expander can be configured to be non-rotatably inserted into the sheath, rotatably inserted into the sheath, or partially non-rotatably and partially rotatably inserted into the sheath. For example, the expander can include a proximal portion having threads formed thereon and a distal portion that is non-threaded and free of surface features. In use, the non-threaded distal portion of the expander can be non-rotatably advanced into the sheath. Once the distal portion is fully disposed within the sheath, the expander can then be rotated to thread the proximal portion into the sheath. The sheath can include corresponding threads along an entire inner surface thereof, or along on a proximal portion of the inner surface thereof, for mating with the threads on the expander.

As indicated above, the sheath <NUM> can be delivered into a bone hole using the sheath inserter tool <NUM>. The sheath inserter tool <NUM> is shown in more detail in <FIG>, and as shown the tool generally includes a cannulated outer shaft <NUM>, an inner shaft <NUM> that extends through the outer shaft <NUM>, and a cannulated handle <NUM> that is mated to both the outer and inner shaft <NUM>, <NUM>. The outer shaft <NUM> has a proximal end 102p that fixedly mates to the handle <NUM> and a distal end 102d having first and second prongs 108a, 108b extending distally therefrom. In the illustrated embodiment, the proximal end 102p includes threads <NUM> formed thereon that threadably engage corresponding threads 106t (shown in <FIG>) formed within the handle <NUM> to fixedly mate the outer shaft <NUM> to the handle <NUM>. Various other mating techniques can be used, such as a snap-fit or other mechanical interlock. The inner shaft <NUM> also has a proximal end 104p that fixedly mates to the handle <NUM>, but that is freely rotatable relative to the handle <NUM> to allow the handle <NUM> to rotate and threadably engage the outer shaft <NUM>.

The handle can have a variety of configurations, but in the illustrated embodiment it has a generally elongate cylindrical shape with an inner lumen extending therethrough. A proximal end of the handle can be generally planar for allowing a mallet to be applied thereto for advancing the anchor coupled to the tool into a bone hole. The outer surface of the handle can have any shape and size to facilitate grasping. As indicated above, an inner lumen of the handle can be configured to receive the proximal ends of the outer and inner shafts <NUM>, <NUM>. The configuration of the inner lumen will be discussed in detail below.

The handle can include features for mating a suture to the handle <NUM>. In the illustrated embodiment, the handle includes opposed wings 106a, 106b that have a suture receiving channel <NUM> formed therearound (shown in <FIG>) for receiving a suture coupled to the implant. Thus, when an implant is being inserted through tissue and into a bone hole, the trailing ends of the suture coupled to the implant can be tensioned and wrapped around one of the wings 106a, 106b. In another embodiment, one or more suture receiving elements can be located on the outer shaft, rather than on the handle. Such a configuration allows the handle and the inner shaft to be removed, leaving the outer shaft with the suture and sheath coupled thereto.

Referring back to <FIG>, the outer shaft <NUM> can have a variety of configurations. The illustrated proximal end 102p of the outer shaft <NUM> is shown having a knurled or other textured surface <NUM> to facilitate grasping thereof. <FIG> also illustrates a window <NUM> formed in a sidewall of the outer shaft <NUM> to enable viewing of the inner shaft <NUM> disposed therein. The window <NUM> can be formed at any location along the length of the outer shaft <NUM>, and the outer shaft <NUM> can include any number of windows formed therein. As indicated above, the proximal end 102p of the outer shaft <NUM> includes threads <NUM> formed on an outer surface thereof for engaging corresponding threads 106t formed within a distal portion of the inner lumen extending through the handle <NUM>, as shown in <FIG>. The threaded engagement allows the handle <NUM>, with the inner shaft <NUM> coupled thereto, to be advanced distally during threaded engagement with the outer shaft <NUM>, thereby advancing a distal end of the inner shaft <NUM> into engagement with the sheath, as will be discussed in more detail below. Threading of the handle <NUM> onto the outer shaft <NUM> will also align the distal end of the inner shaft <NUM> with the sheath <NUM> and the outer shaft <NUM>, as will also be discussed in more detail below.

The distal end 102d of the outer shaft <NUM> is shown in more detail in <FIG>, and as shown the distal end 102d tapers inward in the distal direction and has opposed U-shaped cutouts 103a, 103b formed therein such that the distal end 102d includes first and second opposed arms or prongs 108a, 108b extend distally therefrom and configured to extend along the opposed slots in the sheath <NUM>.

While the prongs 108a, 108b can have a variety of configurations and features, in the illustrated embodiment each prong 108a, 108b is in the form of elongate pin or rod that is integrally formed with the outer shaft <NUM> or fixedly attached to the outer shaft <NUM>. Each prong 108a, 108b is shown having a proximal portion with a width that tapers inward and then flares outward to form a pair of proximal boss 114a, 114b, 114c, 114d. Each prong 108a, 108b also has a distal portion having a generally elongate shape with a substantially square or rectangular cross-section and a substantially constant diameter with a rounded or tapered distal tip. The proximal bosses 114a, 114b, 114c, 114d on the prongs 118a, 118b can abut against the proximal or upper tabs 216a, 216b, 216c, 216d on the sheath <NUM> to prevent proximal movement of the sheath when mated to the sheath inserter tool <NUM>. A pair of distal bosses 116a, 116b, 116c, 116d is formed at a location distal of the proximal bosses 114a, 114b, 114c, 114d around a mid-portion of each prong 118a, 118b. Each of the bosses 116a, 116b, 116c, 116d is in the form of a protrusion extending outward from opposite sides of the prong 108a, 108b.

When the sheath <NUM> is mated to the sheath inserter tool <NUM>, as shown in <FIG>, the upper and central tabs 216a, 218a on the first sidewall <NUM> and the upper and central tabs 216c, 218c on the second sidewall <NUM> will engage the second prong 108b therebetween, and while not shown the upper and central tab 216b, 218b on the first sidewall <NUM> and the upper and central tabs 216d, 218d on the second sidewall <NUM> will engage the first prong 108a therebetween. Due to the elongate generally rectangular configuration of the tabs and the prongs being engaged therebetween, the sheath <NUM> is prevented from rotating as a unit relative to the sheath inserter tool <NUM>.

As further shown in <FIG>, the upper tab 216a on the first sidewall <NUM> will be seated between proximal boss 114c and distal boss 116c on the second prong 108b, and upper tab 216c on the second sidewall <NUM> will be seated between proximal boss 114d and distal boss 116d on the second prong 108b. While not shown, upper tab 216b on the first sidewall <NUM> will be seated between proximal boss 114a and distal boss 116a on the first prong 108a, and upper tab 216d on the second sidewall <NUM> will be seated between proximal boss 114b and distal boss 116b on first prong 108a. As a result, the sheath <NUM> is prevented from moving proximally relative to the prongs 108a, 108b.

As further shown in <FIG>, when the sheath <NUM> is mated to the sheath inserter tool <NUM>, the prongs 108a, 108b will extend a distance beyond the distal end of the sheath <NUM>. Such a configuration allows a tendon to be wrapped around the distal end of the sheath <NUM> and received between the prongs 108a, 108b, and it allows the prongs 108a, 108b to guide the sheath <NUM> into a bone hole.

Referring back to <FIG>, the inner shaft <NUM> of the sheath inserter tool <NUM> can also have a variety of configurations, but is generally in the form of an elongate shaft having a proximal end 104p that is mated to the handle <NUM>, and a distal end 104d that mates to the sheath <NUM>. The proximal end 104p can mate to the handle <NUM> using a variety of techniques, but in an exemplary embodiment the proximal end 104p is fixedly, but freely rotatably mated to the handle <NUM>. In the illustrated embodiment, the proximal end 104p of the inner shaft <NUM> includes a slot formed therein that defines two deflectable arms or fingers 105a, 105b. Each arm or finger 105a, 105b has a flange 107a, 107b on the proximal-most end thereof. The handle <NUM> is configured mate to the proximal end 104p of the inner shaft <NUM> using a snap-fit arrangement. As shown in <FIG>, the inner lumen extending through the handle <NUM> has a portion located proximal of the threads 106t that includes a proximal section 120p with a large diameter and a mid-section 120d with a reduced diameter, such that a step <NUM> is formed therebetween. The diameter of mid-section 120d is configured to receive the inner shaft <NUM> and to cause the fingers 105a, 105b on the proximal end of the inner shaft <NUM> to deflect inward when passed therethrough. Once the flanges 107a, 107b extend proximally past the step <NUM>, the fingers 105a, 105b are allowed to deflect outward back to their resting position, in which the flanges 107a, 107b will engage the step <NUM> to prevent removal of the inner shaft <NUM> from the handle <NUM>. The step <NUM> will also prevent distal movement of the inner shaft <NUM> relative to the handle <NUM>. The handle <NUM> will remain free to rotate relative to the inner shaft <NUM>, thus allowing the handle <NUM> to be threaded onto the outer shaft <NUM> with the inner shaft <NUM> coupled thereto.

The inner shaft <NUM> can also include alignment features formed thereon for aligning the inner shaft with the outer shaft <NUM>, thereby aligning the distal end 104d of the inner shaft <NUM> with the sheath <NUM> coupled to the outer shaft <NUM>. As shown in <FIG>, the inner shaft <NUM> includes opposed elongate protrusions (only one protrusion <NUM> is shown) formed on opposed sides of a proximal end thereof. The outer shaft <NUM> includes corresponding cut-outs or slots (only one slot <NUM> is shown) formed in opposite sides thereof for slidably receiving the protrusions <NUM> therein.

The distal end of the inner shaft <NUM> is shown in more detail in <FIG>, and as shown the distal end has a reduced diameter portion <NUM> and an increased diameter portion in the form of a radial flange <NUM> having a circular shape. The diameter of the flange <NUM> can be substantially the same as the diameter of the sheath <NUM>, and the flange <NUM> can have a substantially planer distal-facing end surface that abuts up against the proximal end of the sheath <NUM>. The end surface can include one or more protrusions formed thereon for mating with the sheath. As shown in FIG. 3E, the end surface includes a central protrusion <NUM> that is configured to be received between the sidewalls of the sheath <NUM>. The central protrusion <NUM> can thus have a size and shape that generally matches the size and shape of the inner lumen of the sheath <NUM>. In the illustrated embodiment, the central protrusion <NUM> has a generally oblong cross-sectional shape. The noncircular geometry can be advantageous as it will prevent rotation of the inner shaft <NUM> relative to the sheath <NUM>.

The end surface of the inner shaft <NUM> can also include one or more protrusions formed adjacent an outer perimeter thereof and configured to extend along an outer surface of each sidewall of the sheath. As shown inFIG. 3E, the end surface includes four protrusions 130a-d formed thereon, with two protrusions 130a, 130b being positioned on a first side to extend along an outer surface of the first sidewall <NUM> of the sheath <NUM>, and the other two protrusions 130c, 130d being positioned on a second, opposite side to extend along an outer surface of the second sidewall <NUM> of the sheath <NUM>. The four protrusions 130a-d have a length and diameter that is significantly less than a length of the central protrusion <NUM>, as the central protrusion is intended to occupy a substantial portion of the inner lumen of the sheath <NUM>. The four protrusions 130a-d can also vary in shape, but in an exemplary embodiment each protrusion has a generally rectangular or square cross-sectional shape and is configured to extend between teeth in the proximal-most row of teeth on the sidewalls of the sheath <NUM>. In particular, as shown in <FIG>, two of the protrusions 130a, 130b located on one side of the inner shaft <NUM> will extend between the proximal-most central tooth 208c and an outer tooth <NUM>. Such positioning of the protrusions 130a, 130b between the teeth can further assist in preventing rotation of the inner shaft <NUM> relative to the sheath <NUM>.

Referring back to <FIG>, when the system <NUM> is assembled, the sheath <NUM> is positioned at the distal end 102d of the outer shaft <NUM> such that the first and second prongs 108a, 108b extend along the elongate slots 200a, 200b in the sheath <NUM> and extend beyond the distal end 200d of the sheath <NUM>. The central protrusion <NUM> on the inner shaft <NUM> will extend into the central lumen of the sheath <NUM>, and the outer protrusions 130a-d on the inner shaft <NUM> will extend around the outer sidewalls of the sheath <NUM>. The upper and lower tabs 216a-d, 218a-d on the sheath <NUM> will engage the prongs 108a, 108b so as to prevent rotation of the sheath <NUM> about an axis extending laterally across a mid-portion of the sheath <NUM>. The upper tabs 216a-d on the sheath <NUM> will be engaged between the proximal and distal bosses 116a-d on the prongs 108a, 108b.

With continued reference to <FIG>, as indicated above the system can also include an expander inserter tool <NUM> for inserting the expander <NUM> through the sheath inserter tool <NUM> and into the sheath <NUM>. In an exemplary embodiment, as shown in <FIG>, the expander inserter tool <NUM> is in the form of a screw driver having a drive tip configured to extend into the expander <NUM>. In particular, the expander inserter tool <NUM> has a handle <NUM> and an elongate shaft <NUM> extending distally from the handle <NUM>. The distal end of the elongate shaft <NUM> includes a drive tip <NUM> formed thereon for engaging the lumen <NUM> in the expander <NUM>. In the illustrated embodiment, the drive tip <NUM> has a hexagonal configuration for extending into a corresponding hexagonal drive socket (shown in <FIG>) formed in the expander <NUM> to thereby allow the expander inserter tool <NUM> to rotate the expander <NUM>. However, one skilled in the art will appreciate that the drive tip <NUM> can have any other configuration so as to fit within the inner lumen of the expander <NUM> and rotatably engage the expander <NUM>.

When assembled, the expander inserter tool <NUM> extends through the outer shaft <NUM> of the sheath inserter tool <NUM> (with the inner shaft <NUM> being removed). The expander inserter tool <NUM> can rotate freely relative to the outer shaft <NUM> so as to thread the expander <NUM> into the sheath <NUM>. <FIG> illustrate the expander inserter tool <NUM> positioned within the outer shaft <NUM> of the sheath inserter tool <NUM> and about to advance the expander <NUM> into the sheath <NUM>. As the expander <NUM> is introduced into the sheath <NUM>, the retention boss (only one boss 219a is shown) will engage the threads on the expander <NUM>. Such a configuration can reduce the likelihood for intra- or post-operative disengagement between the sheath and the expander. Since the diameter of the expander <NUM> is greater than an inner diameter of the sheath <NUM> in the collapsed position, the expander <NUM> will cause the sidewalls <NUM>, <NUM> of the sheath <NUM> to pivot about the pivot pin and thereby expand outward to into bone. The assembly will thus engage the bone thereby anchoring the tendon within the bone hole. <FIG> illustrates a proximal end view of the sheath and expander in the fully implanted configuration.

<FIG> illustrate another embodiment of a biceps tenodesis system <NUM> that includes a sheath inserter tool <NUM> according to an embodiment of the present invention having an expandable sheath <NUM> coupled thereto. The system <NUM> can be used with the expander inserter tool and expander described above, and thus these components are not discussed with respect to this embodiment. In this embodiment, the sheath <NUM> has two separate and distinct halves that are not mated, but rather that have cross-bars that are held together by the sheath inserter tool <NUM> and that receive a tendon therearound. The sheath inserter tool <NUM> can include various feature for mating with and interacting with the sheath.

The sheath <NUM> is shown in more detail in <FIG> and as shown, the sheath <NUM> has first and second sidewalls <NUM>, <NUM> that are configured to couple, but not mechanically mate, to one another. Each sidewall <NUM>, <NUM> has a substantially hemi-cylindrical shape with an inner concave surface 602i, 604i configured to seat the expander, and an outer convex surface with bone-engaging surface features formed thereon for engaging bone within a bone hole. The bone-engaging surface features can have the same configuration as discussed above with respect to sheath <NUM>, or they can have other configurations. As best shown in <FIG>, in this embodiment each sidewall <NUM>, <NUM> has three columns of teeth spaced longitudinally along the sidewall between the proximal and distal ends, namely a central column of teeth 608c, and left and right side columns of teeth <NUM>, 608r. Each tooth is generally rectangular in shape, however a distal facing sidewall 608d of each tooth can be angled toward the proximal end 600p to facilitate insertion into the bone hole, and to prevent proximal movement of the sheath <NUM> once implanted in the bone hole.

As indicated above, a distal end 600d of each sidewall <NUM>, <NUM> can include a cross-bar 610a, 610b formed thereon. Each cross-bar 610a, 610b can extend substantially perpendicular to the longitudinal axis of the sheath <NUM> and can have a length that is substantially the same as or more preferably greater than a width of the sidewalls of the sheath <NUM>. Such a configuration can allow the cross-bars 610a, 610b to be seated within a notch formed in prongs on the sheath inserter tool <NUM>, discussed below. The illustrated cross-bars 610a, 610b have a substantially cylindrical shape with a planar inner surface such that the cross-bars will form a complete cylinder when the sidewalls <NUM>, <NUM> are seated adjacent to one another. A tendon or ligament can be positioned around the cross-bars 610a, 610b and can extend along the outer surface of each sidewall <NUM>, <NUM>. In use, when an expander <NUM> (shown in <FIG>) is inserted into the sheath <NUM>, the sheath inserter tool <NUM> will maintain the cross-bars 610a, 610b in a coupled configuration and thus the sidewalls <NUM>, <NUM> will pivot about a longitudinal axis of the cross-bars 610a, 610b to move apart and engage bone, as will be discussed in further detail below.

As indicated above, the sheath inserter tool <NUM> in this embodiment can include various features for mating with and interacting with the sheath <NUM>. As shown in more detail in <FIG> and <FIG>, the sheath inserter tool <NUM> generally includes an outer shaft <NUM>, an inner shaft <NUM> configured to extend through the outer shaft <NUM>, and a handle <NUM> for coupling to the outer and inner shafts <NUM>, <NUM>. The sheath inserter tool <NUM> can include any of the features described above with respect to the sheath inserter tool <NUM>. In general, the outer shaft <NUM> is similar to the above embodiment and includes opposed first and second prongs <NUM>, <NUM> extending distally from a distal end 510d thereof. A proximal end 510p of the outer shaft <NUM> is configured to fixedly mate to the handle <NUM>, e.g., by a press-fit or other known techniques, such that the outer shaft <NUM> and the handle <NUM> function as a unit. In this embodiment, the handle <NUM> has a generally elongate shape with an outer diameter that increases at a distal end 530d and that tapers radially outward toward the proximal end 530p, however the handle <NUM> can have a variety of shapes and sizes.

The prongs <NUM>, <NUM> extending from the distal end 510d of the outer shaft <NUM> can each have a configuration similar to the prongs described above, however in this embodiment each prong <NUM>, <NUM> includes a notch 502n, 504n formed in the distal-most end thereof for seating the cross-bars 610a, 610b. As shown, each notch 502n, 504n can have a generally circular shape that corresponds to a shape of the cross-bars 610a, 610b when mated. The length of the prongs <NUM>, <NUM> are configured such that the prongs <NUM>, <NUM> will maintain the sheath <NUM> in a position in which a proximal-most end 600p of the sheath <NUM> is aligned with a shoulder <NUM> formed on the distal end 510d of the outer shaft <NUM>. The shoulder <NUM> is configured to abut against an outer surface of bone when the prongs <NUM>, <NUM> are positioned within a bone hole to limit insertion of the outer shaft <NUM> into the bone hole. The prongs <NUM>, <NUM> will thus position the sheath <NUM> at a desired depth within the bone hole.

The prongs <NUM>, <NUM> can include other features similar to those described above. For example, as shown in more detail in <FIG>, each prong <NUM>, <NUM> includes first and second bosses (only two bosses 506a, 506b on prong <NUM> are shown) formed on an internal surface thereof. As shown, the first boss 506a is positioned at or near the proximal end of the prong <NUM> and it can be in the form of a protrusion that is configured to extend between the left row of teeth <NUM> on each sidewall <NUM>, <NUM> of the sheath <NUM>. The second boss 506b is located distal of the first boss 506a, e.g., around a mid-portion of the prong <NUM>, and it can extend between the right row of teeth 608R on each sidewall <NUM>, <NUM> of the sheath <NUM>. The bosses 506a, 506b can function to prevent distal movement of the sheath <NUM> with respect to the sheath inserter tool <NUM>, i.e., to prevent the sheath <NUM> from falling into the bone hole. While <FIG> only illustrates the bosses 506a, 506b on the first prong <NUM>, a person skilled in the art will appreciate that the second prong <NUM> can include a corresponding set of bosses.

<FIG> also illustrates shaped opening <NUM> at the distal end of the inner lumen in the outer shaft <NUM> and located at the proximal end of the prongs <NUM>, <NUM>. The shaped opening <NUM> has a shape that conforms to an outer surface of the inner shaft <NUM> at the distal end so as to receive the inner shaft <NUM> therethrough and to maintain the inner shaft <NUM> in longitudinal alignment with the sheath <NUM> during advancement of the inner shaft <NUM> into the sheath <NUM>. In the illustrated embodiment, the shaped opening <NUM> is circular, however the opening can have various configurations.

<FIG> also illustrates several windows or cut-outs <NUM> formed in the outer shaft <NUM> adjacent the distal end for enabling viewing into the inner lumen, and in particular for enabling viewing of the inner shaft <NUM> as well as the expander inserter tool when positioned within the outer shaft <NUM>. A person skilled in the art will appreciate that the outer shaft <NUM> can have any number of windows or cut-outs formed therein at various locations, as discussed above with respect to outer shaft <NUM>.

As indicated above, the sheath inserter tool <NUM> also includes an inner shaft <NUM> that is configured to extend through the outer shaft <NUM>. Referring back to <FIG>, the inner shaft <NUM> generally has an elongate cylindrical shape with a proximal end having a handle <NUM> formed thereon and a distal end having a plug or distal tip <NUM> configured to extend into the sheath <NUM>. The handle <NUM> can have various configurations, but as shown the handle <NUM> is generally discshaped with a planar proximal end surface for receiving a force from a hammer if necessary. When the inner shaft <NUM> is inserted into the outer shaft <NUM>, the handle <NUM> on the inner shaft <NUM> will abut the proximal end surface of the handle <NUM> coupled to the outer shaft <NUM>, thereby limiting an insertion depth of the distal tip <NUM> on the inner shaft <NUM> into the sheath <NUM>.

As shown in <FIG>, the handle <NUM> on the inner shaft <NUM> can include an anti-rotation lock <NUM> formed thereon and extending distally from a distal-facing surface thereof. The anti-rotation lock <NUM> can be configured to extend into a corresponding slot or bore <NUM> formed in the proximal end of the handle <NUM> coupled to the outer shaft <NUM> to thereby prevent rotation of the inner shaft <NUM> relative to the outer shaft <NUM>. The anti-rotation lock <NUM> and bore <NUM> also facilitate alignment of the distal tip <NUM> with the sheath <NUM>. As further shown in <FIG>, the anti-rotation lock <NUM> can include a protrusion or boss <NUM> formed therein that is configured to engage a corresponding detent or bore <NUM> extending from the bore <NUM>. The boss <NUM> and bore <NUM> create a frictional detect between the handle <NUM> on the inner shaft <NUM> and the handle <NUM> on the outer shaft <NUM>.

The distal tip <NUM> of the inner shaft <NUM> is shown in more detail in <FIG>, and as shown the distal tip <NUM> has a protrusion <NUM>, similar to the protrusion <NUM> discussed above with the previous embodiment. The illustrated protrusion <NUM> has a generally oval-shaped cross-section such that it corresponds to a shape of the inner lumen of the sheath <NUM> when the sidewalls <NUM>, <NUM> are coupled and the sheath <NUM> is in the closed configuration.

As further shown in <FIG>, the inner shaft <NUM> can also include a groove <NUM> formed in the distal end thereof and extending circumferentially around the distal tip <NUM>. The groove <NUM> can have a shape and size that corresponds to a shape and size of the proximal end of each sidewall <NUM>, <NUM> of the sheath <NUM> such that the groove <NUM> is configured to seat the proximal end of each sidewall <NUM>, <NUM> of the sheath <NUM>. As a result of the groove <NUM>, the outer sidewalls of the inner shaft <NUM> will extend around the proximal ends of the sidewalls <NUM>, <NUM> of the sheath <NUM>, thereby preventing movement (e.g., opening) of the sheath <NUM> when the inner shaft <NUM> is coupled to the sheath <NUM>. The inner shaft <NUM> will thus maintain the sheath <NUM> in the closed position.

<FIG> illustrates the sheath <NUM> and sheath inserter tool <NUM> fully assembly, with the distal tip (not shown) of the inner shaft <NUM> fully inserted into the sheath <NUM>. As shown, the cross-bars 610a, 610b on the sheath <NUM> are seated within the notches 502n, 504n in the distal ends of the prongs <NUM>, <NUM>, and the bosses (only two bosses 506a, <NUM> are shown) on the prongs <NUM>, <NUM> extend between the teeth (bosses 506a, 506b are shown extending between the right teeth <NUM>) on the sheath <NUM> to prevent the sheath <NUM> from moving distally relative to the prongs <NUM>, <NUM>. The proximal end of the sheath <NUM> is aligned with the shoulder <NUM> on the outer shaft <NUM>, and the proximal end of each sidewall <NUM>, <NUM> extends into the groove <NUM> in the inner shaft <NUM>. The inner shaft <NUM> will thus maintain the sidewalls <NUM>, <NUM> in the closed position during insertion into a bone hole. The groove <NUM> seating the proximal end of each sidewall <NUM>, <NUM> can also function to apply a distally-directed force on the sheath <NUM> during insertion into a bone hole so as to alleviate some of the force applied to the cross-bars 610a, 610b. Once the sheath <NUM> is fully inserted into the bone hole, the inner shaft <NUM> can be removed from the outer shaft <NUM> and the expander inserter tool <NUM> can be advanced through the outer shaft <NUM> to drive the expander <NUM> into the sheath <NUM> and thereby expand and anchor the sheath <NUM>, and a tendon positioned there around, within the bone hole. As the sheath <NUM> is expanded, the bosses will become disengaged with the teeth on the sheath sidewalls <NUM>, <NUM>, thus allowing the outer shaft <NUM> to be subsequently removed.

The systems described herein can be used to implant a sheath or anchor in a bone in various different ways. One exemplary method for implanting an anchor in bone, for example, to perform a biceps tenodesis surgery, is described in <CIT> and entitled "Biceps Tenodesis Implants and Delivery Tools,".

In a biceps tenodesis procedure, a biceps tendon is retrieved in a suitable manner and a size of the tendon is determined to allow a surgeon to select an appropriately sized implant and tools. Further, in some embodiments, the sheath inserter tool <NUM> or <NUM> can be used to size the tendon by using the prongs 108a, 108b or <NUM>, <NUM>. Tools having different sizes can have differently sized prongs or forks. After properly sizing the tendon, the proper size reamer can be used to ream a bore in the bone, e.g., the humerus. However, a person skilled in the art will appreciate that the bone hole can be formed using any suitable bone hole preparation techniques and devices.

The bone hole diameter can be sized to allow the prongs having a tendon positioned between the prongs thereof and around the sheath to be easily inserted therein. If sheath <NUM>' is used, the depth-stop tabs 221a', 221b' on the sheath <NUM>' can prevent over insertion of the sheath into the bone hole. In other embodiments, the outer shaft, e.g., outer shaft <NUM> of sheath inserter tool <NUM>, can include laser markings formed therein for indicating the insertion. In yet another embodiment, the outer shaft, e.g., outer shaft <NUM> of sheath inserter tool <NUM>, can include a shoulder <NUM> formed thereon having a greater diameter compared to the bone hole, so that the outer shaft <NUM> will be prevented from entering into the bone hole.

After a bone hole in bone is prepared, the sheath coupled to a distal end of the sheath inserter tool can be positioned adjacent to the tendon to be advanced into the bone hole. The inserter tool with the sheath coupled thereto can be advanced into the bone hole, and the inner shaft, e.g., inner shaft <NUM> or <NUM>, can be removed leaving the outer shaft, e.g., outer shaft <NUM> or shaft <NUM> in place holding the sheath within the bone hole. The expander inserter tool, e.g., tool <NUM>, can be advanced with the expander <NUM> coupled thereto through the outer shaft and it can be driven into the sheath. A surgeon can hold the handle coupled to the outer shaft of the sheath inserter tool so that the handle remains stationary while the expander inserter tool is rotated. The outer shaft of the sheath inserter tool will thus prevent rotation of the sheath during rotation of the expander into the sheath. The expander will cause the sheath to expand, with the proximal end expander radially outward by a distance that is greater than the distal end. The sheath will engage the bone hole with the tendon therebetween, thus anchoring the tendon within the bone hole. It should be appreciated that in some embodiments a guidewire and/or a suture can be additionally used.

A person skilled in the art will appreciate that the biceps tenodesis methods and devices disclosed herein can be used in a variety of surgical procedures to prevent trauma or damage to a tendon being attached to a bone via a bone hole. The present invention also has application in conventional joint repair surgeries.

The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly.

Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

It is preferred that device is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam.

Claim 1:
A bone anchor inserter tool (<NUM>, <NUM>), comprising:
an elongate shaft (<NUM>, <NUM>) having proximal and distal (102d, 510d) ends and an inner lumen extending therethrough, the distal end having first and second prongs (108a, 108b, <NUM>, <NUM>) extending distally therefrom and positioned on opposite sides of the shaft,
characterized in that each prong (108a, 108b, <NUM>, <NUM>) has a first boss (114a, 114b, 114c, 114d, 506a) positioned adjacent a proximal end of each prong and a second boss (116a, 116b, 116c, 116d, 506b) positioned adjacent a mid-portion of each prong.