Patent Description:
With its complexity, range of motion and extensive use, a common soft tissue injury is damage to the rotator cuff or rotator cuff tendons. Damage to the rotator cuff is a potentially serious medical condition that may occur during hyperextension, from an acute traumatic tear or from overuse of the joint. There is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body. An implant delivery system according to the preamble of claim <NUM> is known from the document <CIT>.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices.

The present invention relates to an implant delivery system as set forth in the appended claims. The implant delivery system includes an outer shaft having a proximal end, a distal end and lumen extending therein. The implant delivery system also includes an inner shaft including a proximal end and a distal end. The inner shaft extends within a least a portion of the lumen of the outer shaft. A yoke is coupled to the distal end of the inner shaft. An implant retainer is coupled to the yoke. The implant retainer is configured to capture an implant. The implant retainer is configured to pivot relative to the yoke.

Additionally to any example above, the implant delivery system further includes a spring component coupled to both the yoke and the implant retainer.

Additionally to any example above, the spring component includes a first end and a second end, wherein the first end is fixedly attached to the yoke, and wherein the second end extends away from the yoke and is positioned within an internal bore located on the implant retainer.

Additionally to any example above, the spring component includes a first end and a second end, wherein the first end is fixedly attached to the implant retainer, and wherein the second end extends away from the implant retainer and is positioned within an intemal bore located on the yoke.

Additionally to any example above, the spring component is configured to flex between a first position in which it is aligned with a longitudinal axis of the yoke and a second position in which it is offset from the longitudinal axis of the yoke.

Additionally to any example above, the spring component is configured to bias the implant retainer in the second position after the implant is deployed from the lumen of the outer shaft.

Additionally to any example above, the implant retainer includes an upper beam coupled to a lower beam, and wherein the implant is captured between the upper beam and the lower beam.

Additionally to any example above, the lower beam includes a spring component coupled to the upper beam, and wherein the spring component includes a proximal end portion which extends into a bore of the yoke.

Additionally to any example above, the yoke includes a first longitudinal arm spaced away from a second longitudinal arm, and wherein the first longitudinal arm includes a first recess configured to accept a first projection positioned on the implant retainer, and wherein the second longitudinal arm includes a second recess configured to accept a second projection positioned on the implant retainer.

Additionally to any example above, the first projection is configured to pivot within the first recess and wherein the second projection is configured to pivot within the second recess.

Another example not part of the present invention includes an implant delivery system. The implant delivery system includes a handle having a distal end region, a proximal end region and a channel extending from the distal end region to the proximal end region. A delivery sheath extends distally from the handle. The delivery sheath has a lumen extending to a distal end of the delivery sheath. A delivery shaft is positioned in the lumen of the delivery sheath. The delivery shaft has a distal end, a proximal end and a lumen extending therein. A frame is coupled to the distal end of the delivery shaft. The frame is attachable to a sheet-like implant. An actuation member is translatable within the channel to deploy the frame from the delivery sheath. A tether extends from the frame within the lumen of the delivery shaft and at least a portion of the handle. A tether clamp is positioned within the handle. The tether clamp is manipulatable by the actuation member to selectively unlock the tether within the handle.

Additionally or alternatively to any example above, unlocking the tether clamp permits the tether to translate with respect to the handle, the delivery shaft or both the handle and the delivery shaft.

Additionally or alternatively to any example above, translating the actuation member from a distal end region of the channel to a proximal end region of the channel shifts the delivery sheath in a proximal direction relative to the delivery shaft from a first position to a second position.

Additionally or alternatively to any example above, the tether clamp includes a locking lever designed to rotate between a first position in which the lever locks the tether to the handle and a second position in which the tether is free to translate with respect to the handle.

Additionally or alternatively to any example above, the actuation member further includes an engagement member configured to engage the locking lever, and wherein rotation of the actuation member engages the engagement member with the lever such that the lever rotates from the first position in which the lever locks the tether to the handle to the second position in which the tether is free to translate with respect to the handle.

Additionally or alternatively to any example above, the tether clamp includes a moving component positioned adjacent to a fixed component, wherein the moving component is designed to move between a first position in which the tether is locked between the moving component and the fixed component, and a second position in which the tether is free to translate with respect to the moving component and the fixed component.

Additionally or alternatively to any example above, a spring is attached to the moving component. The spring is configured to apply a force to the moving component to lock the tether between the moving component and the fixed component.

Additionally or alternatively to any example above, the actuation member further includes an engagement member configured to engage the moving component, and wherein rotation of the actuation member engages the engagement member with the moving component such that the moving component translates between the first position in which the moving component locks the tether to the handle and the second position in which the tether is free to translate with respect to the moving component and the fixed component.

Additionally or alternatively to any example above, the tether clamp includes a locking block including a slot extending between adjacent first and second sidewalls of the locking block through which the tether extends, and an engagement feature designed to engage a mating engagement feature of the actuation member. The first sidewall of the locking block is configured to move relative to the second sidewall of the locking block between a first position in which the tether is pressed between the first and second sidewalls and a second position in which the tether is free to translate within the slot.

Additionally or alternatively to any example above, rotation of the actuation member rotates the first sidewall between the first position in which the tether is locked within the slot of the locking block and the second position in which the tether is free to translate within the slot.

The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which <FIG> do not show a delivery device according to the invention.

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

With its complexity, range of motion and extensive use, a common soft tissue injury is damage to the rotator cuff or rotator cuff tendons. Damage to the rotator cuff is a potentially serious medical condition that may occur during hyperextension, from an acute traumatic tear or from overuse of the joint. An accepted treatment for rotator cuff tears may include reattaching the torn tendon to the humeral head using sutures. Additionally, in treating rotator cuff tears, an accepted practice may also include the placement of a scaffold over the repaired tendon to mechanically reinforce the repaired tendon and/or promote tissue reformation. Therefore, there is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body.

<FIG> shows an example implant delivery system <NUM>. The example implant delivery system <NUM> may include a handle <NUM> having a trigger <NUM>. Additionally, the implant delivery system <NUM> may include an outer shaft <NUM> coupled to the handle <NUM>.

Further, <FIG> illustrates that the implant delivery system <NUM> includes an inner shaft <NUM> extending within the outer shaft <NUM>. The implant delivery system <NUM> includes an implant delivery device assembly <NUM> coupled to the distal end region of the inner shaft <NUM> via a yoke <NUM>. The implant delivery device assembly <NUM> may include a swivel arm <NUM> coupled to an implant <NUM>.

The outer shaft <NUM> of the implant delivery system <NUM> may include a proximal end (attached to the handle <NUM>), a distal end and a lumen extending within at least a portion of the outer shaft <NUM>. In some examples, the distal end of the outer shaft <NUM> may be attached to a delivery sheath <NUM>. In other words, the delivery sheath <NUM> may extend away from the distal end of the outer shaft <NUM> whereby the distal end of the outer shaft <NUM> may be attached to a proximal end of the delivery sheath <NUM>. In some examples, the delivery sheath <NUM> may resemble a substantially cylindrical sheath, a portion of which may be over-molded onto the distal end of the outer shaft <NUM>. The delivery sheath <NUM> may be designed to house the implant delivery device assembly <NUM> (including the implant <NUM>) in a rolled, folded or otherwise collapsed delivery state as the implant delivery system <NUM> accesses a target site.

For clarity, <FIG> illustrates the implant delivery device assembly <NUM> extending out of the distal end of the delivery sheath <NUM>. It can be appreciated that the implant delivery device assembly <NUM> may be positioned within the lumen of the delivery sheath <NUM> prior to being deployed out of the distal end of the delivery sheath <NUM>. For example, the implant delivery device assembly <NUM> (including the implant <NUM>) may be positioned in a rolled, folded or otherwise collapsed delivery configuration within the lumen of the delivery sheath <NUM> while being tracked to a target site.

It can be further appreciated that actuation of the trigger <NUM> may shift the outer shaft <NUM> relative to both the implant assembly <NUM> and the inner shaft <NUM>. For example, actuation of the trigger <NUM> may shift the outer shaft <NUM> between a first position in which the implant assembly <NUM> is positioned within the lumen of the delivery sheath <NUM> and a second position in which the outer shaft <NUM> has been retracted proximally relative to the inner shaft <NUM>, thereby deploying the implant assembly <NUM> out of the distal end region of the delivery sheath <NUM>. The individual components of the implant assembly <NUM> will be described in greater detail below.

<FIG> shows a cross-sectional view of a shoulder <NUM>. The shoulder <NUM> shows a head <NUM> of the humerus <NUM> mating with a glenoid fossa <NUM> of the scapula <NUM>. The glenoid fossa <NUM> comprises a shallow depression in the scapula <NUM>. A supraspinatus tendon <NUM> is also shown. These muscles (along with others) control the movement of the humerus <NUM> relative to the scapula <NUM>. Additionally, <FIG> illustrates that a distal tendon <NUM> of the supraspinatus tendon <NUM> meets the humerus <NUM> at an insertion point <NUM>.

In <FIG>, the tendon <NUM> includes a damaged portion <NUM> located near the insertion point <NUM>. The damaged portion <NUM> includes a tear <NUM> extending partially through the tendon <NUM>. The tear <NUM> may be referred to as a partial thickness tear. The depicted partial thickness tear <NUM> is on the bursal side of the tendon, however, the tear may also be on the opposite or articular side of the tendon <NUM> and/or may include internal tears to the tendon <NUM> not visible on either surface.

<FIG> further illustrates the implant delivery system <NUM> being utilized to insert the tendon repair implant <NUM> into the shoulder <NUM> and place it over the partial thickness tear <NUM>. In the example shown in <FIG>, the tendon repair implant <NUM> is placed on the bursal side of the tendon regardless of whether the tear is on the bursal side, articular side or within the tendon. Further, the tendon repair implant <NUM> may overlay multiple tears.

It can be appreciated from <FIG> that delivery of the implant <NUM> (e.g., a sheet-like implant) to a target site of a patient may require a physician to create an incision in the patient sufficient to access the implant site. After creating the access site, the physician may insert a portion of the implant delivery system <NUM> through the access site and position the distal end of the implant delivery system <NUM> adjacent the target implant site. The physician may then manipulate the implant delivery system <NUM> to deploy the implant delivery device assembly <NUM> (including the implant <NUM>) out of the delivery sheath <NUM> adjacent the target implant site.

<FIG> illustrates that the implant delivery system <NUM> may include an inner shaft <NUM> extending within the lumen of the delivery sheath <NUM> and longitudinally movable relative thereto. The inner shaft <NUM> may include a proximal end (not shown) extending out of the proximal end of the delivery sheath <NUM> and/or otherwise manipulatable relative to the delivery sheath <NUM> by a user. As described above with respect to <FIG>, the proximal end of the inner shaft <NUM> and/or the outer shaft <NUM> may be coupled to a handle <NUM> (shown in <FIG>). The handle <NUM> may be utilized to manipulate the inner shaft <NUM> relative to the outer shaft <NUM> and the delivery sheath <NUM>. For example, trigger <NUM> may be actuated to impart longitudinal movement of the inner shaft <NUM> relative to the outer shaft <NUM> and the delivery sheath <NUM>.

Additionally, <FIG> illustrates that the distal end of the inner shaft <NUM> may be coupled to a yoke <NUM>. Additionally, the yoke <NUM> may be coupled to the implant assembly <NUM>, whereby the implant assembly <NUM> may include an implant retainer, such as a swivel arm <NUM>, coupled to the implant <NUM>. Further, the swivel arm <NUM> may include an upper beam <NUM> and a lower beam <NUM>. It can be appreciated that the swivel arm <NUM> may be constructed as a monolithic component including an upper beam <NUM> and a lower beam <NUM>. However, in other instances, the upper beam <NUM> and the lower beam <NUM> may be separate components secured together. Further, the upper beam <NUM> may be aligned longitudinally with the lower beam <NUM>.

Additionally, in some examples, the implant retainer (e.g., the swivel arm <NUM>) may include one or more flexible arms <NUM>. Further, in some examples, the one or more flexible arms <NUM> may be coupled to the upper beam <NUM> and/or the implant <NUM>. As will be described in greater detail below, the implant <NUM> may be secured between the upper beam <NUM> and the lower beam <NUM>, with the one or more flexible arms <NUM> positioned along an upper side of the implant <NUM>. In some instances, the one or more flexible arms may be constructed from a shape-memory material (e.g., Nitinol) such that the flexible arms <NUM> may be flexed, bent, or otherwise deflected for placement within the delivery sheath <NUM>.

<FIG> further illustrates that the upper beam <NUM> (which may include the one or more arms <NUM>), the lower beam <NUM> and the implant <NUM> rotate (e.g., pivot, swivel, etc.) with respect to the yoke <NUM>. For example, <FIG> illustrates that after the swivel arm <NUM> (including the upper beam <NUM>, the lower beam <NUM> and the arms <NUM>) and the implant <NUM> are deployed out of the distal end of the delivery sheath <NUM> (via actuation of the trigger <NUM> of the handle <NUM>), the swivel arm <NUM> and the implant <NUM> pivot relative to the yoke <NUM> as a user manipulates the placement of the implant <NUM> along the tendon target site. For instance, the swivel arm <NUM> and the implant <NUM> rotate about a rotational axis extending perpendicular to the longitudinal axis of the inner shaft <NUM> and/or outer shaft <NUM>. Rotation of the swivel arm <NUM> and the implant <NUM> relative to the yoke <NUM> will be described in greater detail below.

As described above, <FIG> illustrates a perspective view of a portion of the implant delivery system <NUM>. <FIG> shows the inner shaft <NUM> extending out of a distal end of the delivery sheath <NUM>. Further, <FIG> illustrates the proximal end region of the yoke <NUM> attached to the distal end of the inner shaft <NUM>. Further yet, <FIG> illustrates the swivel arm <NUM> pivotably coupled to the yoke <NUM>.

In at least some examples, as described above, the implant <NUM> may be disposed between the upper beam <NUM> and the lower beam <NUM>, whereby the upper beam <NUM> and the lower beam <NUM> may releasably retain the implant <NUM> therebetween. For example, the upper beam <NUM> and the lower beam <NUM> may passively retain the implant <NUM> when the implant <NUM> is positioned between the upper beam <NUM> and the lower beam <NUM>, such as by contact forces between the upper beam <NUM> and the implant <NUM> and the lower beam <NUM> and the implant <NUM>. However, in other examples, the implant <NUM> may include one or more features which help retain the implant <NUM> between the upper beam <NUM> and the lower beam <NUM>.

Additionally, as described above, when the implant <NUM> is disposed between the upper beam <NUM> and the lower beam <NUM>, the implant <NUM> may be positioned such that the one or more arms <NUM> engage the upper face of the implant <NUM> along with the upper beam <NUM>. It can be appreciated that the arms <NUM> may aid in unfolding, unwrapping, flattening, or otherwise manipulating the positioning of the implant <NUM> at a target site.

<FIG> illustrates the flexible arms <NUM> in a deployed configuration. It can be appreciated that in a deployed configuration, the arms <NUM> may include four flat heads positioned at a distal end region of each of the four arms, respectively, whereby each of the four arms extend at an angle from the upper beam <NUM>. It can be further appreciated that, in some examples, the arms <NUM> may be separate components that are fixedly attached to the upper beam <NUM>. However, in other examples, the flexible arms <NUM> may be formed as a monolithic component with the upper beam <NUM>.

Additionally, as described above, it can be appreciated that the arms <NUM> may be designed to fit within the lumen of the delivery sheath <NUM> when being advanced to a target site. Accordingly, it can be further appreciated that, when positioned within the lumen of the delivery sheath <NUM>, each arm <NUM> may elastically deform, fold, deflect, bend, flex, etc. in a manner to allow for insertion of implant device <NUM> into the lumen of the delivery sheath <NUM>. Accordingly, the arms <NUM> may generally be flexible, whereby each arm <NUM> may bend, twist, fold, wrap or otherwise deform in order for implant <NUM> to fit within the delivery sheath <NUM> and then revert to an expanded state (shown in <FIG>) when unconstrained by the delivery sheath <NUM>.

<FIG> further illustrates the swivel arm <NUM> (which may include the upper beam <NUM> and the lower beam <NUM>) coupled to the yoke <NUM>. In some examples, the yoke <NUM> may generally include a "U-shaped" component defined by a first longitudinal arm <NUM> and a second longitudinal arm <NUM>. As illustrated in <FIG>, the first longitudinal arm <NUM> may be spaced away from the second longitudinal arm <NUM> to define an opening <NUM> (e.g., slot) within which a proximal portion of the swivel arm <NUM> may be positioned. It can be appreciated that the opening <NUM> permits the swivel arm <NUM> (including the upper beam <NUM> and the lower beam <NUM>) to rotate relative to the longitudinal axis of the yoke <NUM>. For reference, <FIG> illustrates a configuration in which the upper beam <NUM> and the lower beam <NUM> are aligned substantially parallel to the longitudinal axis of the yoke <NUM>, and thus substantially parallel to the longitudinal axis of the inner shaft <NUM>. Further, <FIG> illustrates the rotation of the upper beam <NUM> and the lower beam <NUM> about a rotational axis perpendicular to the longitudinal axis of the yoke <NUM> and the inner shaft <NUM> such that the swivel arm <NUM> is angled away from the longitudinal axis of the yoke <NUM>. In some embodiments the swivel arm <NUM> may be permitted to rotate to an angle of <NUM> degrees or more, <NUM> degrees or more <NUM> degrees or more, or <NUM> degrees or more away from the longitudinal axis of the yoke <NUM> and the inner shaft <NUM>.

<FIG> further illustrates that the implant delivery system <NUM> may include a spring component <NUM> configured to position the swivel arm <NUM> at a desired equilibrium position or non-deflected position, yet allow the swivel arm <NUM> to pivot or rotate away from the equilibrium position when subjected to an external force. For example the spring component <NUM> may be coupled between the yoke <NUM> and the swivel arm <NUM>, for example extending from a proximal portion of the yoke <NUM> into a proximal region of the swivel arms <NUM>. As will be described in greater detail below, the spring component <NUM> may be designed to elastically flex from a first configuration in which it is substantially parallel to the longitudinal axis of the yoke <NUM>, to a second configuration in which it curves away from the longitudinal axis of the yoke <NUM>. The spring component <NUM> and its configuration relative to the yoke <NUM> and the swivel arm <NUM> will be described in greater detail below.

<FIG> is a partially exploded view of the implant delivery system <NUM> described in <FIG>. Specifically, <FIG> illustrates the implant assembly <NUM> (including the swivel arm <NUM> and the implant <NUM>) removed from the yoke <NUM>. As discussed above, <FIG> illustrates that the upper beam <NUM> may be vertically aligned with the lower beam <NUM>, whereby the implant <NUM> is sandwiched between the upper beam <NUM> and the lower beam <NUM>. Further, <FIG> illustrates that, in some examples, the proximal end region of the swivel arm <NUM> may include one or more projections <NUM> extending away from the lateral faces (e.g., the left and right sides) of the swivel arm <NUM>. The projections <NUM> may be substantially cylindrical in shape, however, other shapes are contemplated. For example, the projections may be rounded, ovular, triangular, pointed, or the like. In other examples, the projections may be semi-spherical in shape and resemble rounded bumps extending away from the lateral faces of the swivel arm <NUM>.

<FIG> further illustrates that the proximal end region of the swivel arm <NUM> may further include a longitudinally extending bore positioned therein. It can be appreciated that the longitudinally extending bore <NUM> may be designed to accept the spring component <NUM> (shown extending out of the proximal end region of the yoke <NUM> in <FIG>). While the spring component <NUM> and the bore <NUM> are illustrated as generally including a rectangular shape in <FIG>, other configurations are contemplated. For example, it is contemplated that the spring component <NUM> may be shaped as a flat ribbon, a cylinder, a spiral, a coil, a zig-zag, a tube, or the like. Further, the spring component <NUM> may include one or more undulations, waves, etc. It can be further appreciated that for any given shape and/or configuration the spring component <NUM> includes, the bore <NUM> may include a mating shape which accepts the particular shape of the spring component <NUM>. In other embodiments, the spring component <NUM> may be secured to and extend proximally from the swivel arm <NUM> into a bore formed in the yoke <NUM>.

<FIG> further illustrates that the yoke <NUM> may further include one or more longitudinal channels <NUM>, each of which are positioned along an interior surface of the yoke <NUM> (e.g., an interior surface of each of the first longitudinal arm <NUM> and the second longitudinal arm <NUM>) and extend proximally from the distally facing front face <NUM> of the yoke <NUM>. Additionally, <FIG> illustrates that each channel <NUM> may be positioned vertically between the top surface and the bottom surface of the yoke <NUM>. For example, in some instances, each channel <NUM> may be located approximately halfway between the top surface and the bottom surface of the yoke <NUM>.

Additionally, <FIG> illustrates that the yoke <NUM> may include one or more recesses <NUM> which are designed to mate with the one or more projections <NUM> of the swivel arm <NUM>. As illustrated in <FIG>, the one or more recesses <NUM> may be positioned along each of the longitudinal channels <NUM> extending along the interior surface of the yoke <NUM>. Additionally, each of the dashed lines <NUM> illustrates that each of the projections <NUM> on the swivel arm <NUM> may be configured to be aligned and inserted into each of the recesses <NUM> positioned along the interior surface of the yoke <NUM>, respectively.

It can be further appreciated from <FIG> that the swivel arm <NUM> may be coupled to the yoke <NUM> by aligning, inserting and sliding each of the projections <NUM> into each of the longitudinal channels <NUM> extending from the front face <NUM> of the yoke <NUM>. For example, each of the projections <NUM> may be aligned with its respective longitudinal channel <NUM>, whereby the swivel arm <NUM> may then be slid in a distal-to-proximal direction such that each of the projections <NUM> may be inserted into its respective recess <NUM>. It can be appreciated that the projections <NUM> may be designed to be press-fit into the recesses <NUM> such that the swivel arm <NUM> may be prevented from being separated from the yoke <NUM>, yet still may be free to pivot relative to the yoke <NUM> about a rotational axis extending through the projections <NUM>.

It can be appreciated that while <FIG> illustrates that while the projections <NUM> may be designed to be inserted into the recesses <NUM> positioned along the yoke <NUM>, it is also contemplated that, in other examples, the swivel arm <NUM> may include one or more recesses designed to accept one or more projections extending from the inner surfaces of the yoke <NUM>. In other words, in some examples, the yoke <NUM> may include one more projections which may be located where the recesses <NUM> are illustrated in <FIG>, while the swivel arm <NUM> may include one or more mating recesses located where the projections <NUM> are illustrated in <FIG>. This alternative arrangement would still provide a press-fit arrangement between the projections and the recesses such that the swivel arm <NUM> may be prevented from being separated from the yoke <NUM>, yet still may be free to pivot relative to the yoke <NUM> about a rotational axis extending through the projections.

Additionally, while <FIG> illustrates that the implant delivery system <NUM> may include longitudinal channels <NUM> extending from the front face <NUM> of the yoke <NUM>, it is also contemplated that the implant delivery system <NUM> may include one or more vertical channels extending from the upper or lower surface of the yoke <NUM>. In these examples, the projections <NUM> of the swivel arm <NUM> may be free to translate vertically within the vertical channels. In other words, the "pivot point" of the swivel arm (e.g., the rotational axis which may correspond and extend through the projections <NUM>) may be free to move vertically up or down (toward the upper of lower surface) of the yoke <NUM> as the swivel arm <NUM> rotates relative to the yoke <NUM>.

Additionally, while <FIG> illustrates that spring component <NUM> may be fixedly attached to the yoke <NUM> and extend into a bore <NUM> located in the proximal end region of the swivel arm <NUM>, it is contemplated that, in other examples, the spring component <NUM> may be fixedly attached to the proximal end region of the swivel arm <NUM> and extend into a bore located in the yoke <NUM>. This arrangement would still permit the spring component <NUM> to shift between a first configuration in which it is substantially parallel to the longitudinal axis of the yoke <NUM> and a second configuration in which it flexes relative to the longitudinal axis of the yoke <NUM>.

<FIG> illustrates a cross-sectional view of the implant positioning assembly <NUM> taken along line <NUM>-<NUM> of <FIG>. <FIG> illustrates the implant <NUM> being positioned between the upper beam <NUM> and the lower beam <NUM> of the swivel arm <NUM>. Further, <FIG> illustrates the proximal end region of the swivel arm <NUM> positioned within the opening <NUM> shown in <FIG>) of the yoke <NUM>. Additionally, <FIG> shows the spring component <NUM> fixedly attached to the proximal end portion of the yoke <NUM> and extending into the bore <NUM> located in the proximal end region of the swivel arm <NUM>.

<FIG> illustrates the implant delivery system <NUM> including the inner shaft <NUM>, the yoke <NUM>, the swivel arm <NUM> and the implant <NUM> positioned within the lumen <NUM> of the delivery sheath <NUM>. As discussed above, the swivel arm <NUM> may include the upper beam <NUM> and the lower beam <NUM> between which the implant <NUM> is positioned (it is noted that, for simplicity purposes, the flexible fingers <NUM> are not shown in <FIG>). <FIG> further illustrates the projection <NUM> of the swivel arm <NUM> positioned within the recess <NUM> of the yoke <NUM>. Additionally, <FIG> illustrates the spring component <NUM> fixedly attached to the proximal end portion of the yoke <NUM> and extending into the bore <NUM> (shown in <FIG>) located in the proximal end region of the swivel arm <NUM>. It can be appreciated that when positioned within the lumen <NUM> of the delivery sheath <NUM> (e.g., in a delivery configuration prior to being deployed from the delivery sheath <NUM>), the swivel arm <NUM> (including the upper beam <NUM> and the lower beam <NUM>) and the implant <NUM> may be aligned substantially parallel to the longitudinal axis <NUM> of the delivery sheath <NUM>.

<FIG> illustrates the implant delivery system <NUM> shown in <FIG> after the outer shaft <NUM> has been retracted in a distal-to-proximal direction. As discussed above, actuation of the trigger <NUM> of the handle <NUM> (shown in <FIG>) may retract the outer shaft <NUM> and delivery sheath <NUM> relative to the inner shaft <NUM>, yoke <NUM>, swivel arm <NUM> (including the upper beam <NUM> and the lower beam <NUM>) and the implant <NUM>. Accordingly, <FIG> illustrates that the proximal retraction of the outer shaft <NUM> may deploy the yoke <NUM>, the swivel arm <NUM> (including the upper beam <NUM> and the lower beam <NUM>) and the implant <NUM> out of the delivery sheath <NUM>.

<FIG> further illustrates that after being deployed out of the delivery sheath <NUM>, the swivel arm <NUM> may rotate relative to the yoke <NUM>. For example, <FIG> illustrates the swivel arm <NUM> (including the upper beam <NUM> and the lower beam <NUM>) may rotate away from the longitudinal axis <NUM> (rotation of the swivel arm <NUM> is depicted by the curved arrow <NUM> in <FIG>). As described above, it can be appreciated that the swivel arm <NUM> may pivot about the recess <NUM> of the yoke <NUM>.

It can be further appreciated that, in some examples, the spring component <NUM> may bias the swivel arm <NUM> to rotate from the position shown in <FIG> (whereby the swivel arm <NUM> is aligned with the longitudinal axis <NUM>) to the position shown in <FIG> (whereby the swivel arm <NUM> is rotated away from the longitudinal axis <NUM>). For example, in some examples, the spring component <NUM> may be constructed from a shape-memory material (e.g., a nickel-titanium alloy) which allows it to flex or otherwise deform after the outer shaft <NUM> is retracted, thereby rotating the swivel arm <NUM> relative to the yoke <NUM>, as described above.

However, in other instances, the spring component <NUM> may be designed such that it biases the swivel arm <NUM> to be aligned with the longitudinal axis <NUM>, yet still permits the swivel arm <NUM> to rotate relative to the yoke <NUM>. Referring back to <FIG>, for example, the implant delivery system <NUM> may be designed such that the swivel arm <NUM> may initially be deployed out of the delivery sheath <NUM> in a substantially straight configuration, whereby the swivel arm <NUM> may then rotate with respect to the yoke <NUM> from an applied external force as the swivel arm <NUM> (and implant <NUM>) are positioned closer to the tendon target site.

<FIG> illustrates a portion of another example implant delivery system <NUM>. The portion of the implant delivery system <NUM> shown in <FIG> may be similar in form and function to the implant delivery system <NUM> described above. For example, the implant delivery system <NUM> may include an inner shaft <NUM> extending within the lumen <NUM> of the delivery sheath <NUM>. Further, the distal end of the inner shaft <NUM> may be coupled to a yoke <NUM>. Additionally, a swivel arm <NUM> may be pivotably coupled to the yoke <NUM>. The swivel arm <NUM> may include an upper beam <NUM> and a lower beam <NUM>. Further, an implant <NUM> may be positioned between the upper beam <NUM> and the lower beam <NUM> with the upper beam <NUM> and the lower beam <NUM> applying a compressive force on the implant <NUM> to securely hold the implant <NUM> therebetween. The swivel arm <NUM> may further include one or more projections <NUM> which engage one or more recesses on the yoke <NUM>, thereby permitting the upper beam <NUM> and the lower beam <NUM> to rotate relative to the yoke <NUM> about a rotational axis extending through the projections <NUM> and perpendicular to the longitudinal axis of the inner shaft <NUM> and yoke <NUM>.

<FIG> further illustrates that, in some examples, the lower beam <NUM> may be formed from a material which is similar in form and function to the material utilized to construct the spring component <NUM> in the implant delivery system <NUM> described above. For example, the lower beam <NUM> may be formed from an elastic material (e.g., a flexible metal material) designed to flex or deflect between a first position (e.g., a position in which the swivel arm <NUM> is aligned with the longitudinal axis <NUM>) to a second position shown in <FIG> (e.g., a position in which the swivel arm <NUM> is rotated away from the longitudinal axis <NUM>). In some examples, the lower beam <NUM> may be constructed from a shape-memory material (e.g., a nickel-titanium alloy).

In some examples, the lower beam <NUM> may be constructed from a shape-memory material which biases the swivel arm <NUM> to rotate from the axially aligned position shown in <FIG> (whereby the swivel arm <NUM> is aligned with the longitudinal axis <NUM> of the delivery sheath <NUM>) to the angled position shown in <FIG> (whereby the lower beam <NUM> bends and rotates the swivel arm <NUM> away from the longitudinal axis <NUM> of the delivery sheath <NUM> to position the swivel arm <NUM> at an oblique or perpendicular angle to the longitudinal axis <NUM>). In some examples, the lower beam <NUM> may be constructed from a shape-memory material (e.g., a nickel-titanium alloy) which allows it to bend or otherwise deform after the delivery sheath <NUM> is retracted, thereby rotating the swivel arm <NUM> relative to the yoke <NUM> as described above.

However, in other instances, the lower beam <NUM> may be designed such that it biases the swivel arm <NUM> to be aligned with the longitudinal axis <NUM>, yet still permits the swivel arm <NUM> to rotate relative to the yoke <NUM> when subjected to an applied external force. Referring back to <FIG>, for example, the implant delivery system <NUM> may be designed such that the swivel arm <NUM> may be initially deployed out of the delivery sheath <NUM> in a substantially straight configuration, whereby the swivel arm <NUM> may rotate with respect to the yoke <NUM> from an applied external force as the swivel arm <NUM> (and the implant <NUM>) are positioned closer to the tendon target site.

It can be appreciated that the lower beam <NUM> may be attached to the upper beam <NUM> using a variety of attachment techniques. In some instances, the lower beam <NUM> may be fixedly attached to the upper beam <NUM> using an adhesive, screws, pins, tongue and groove techniques, or the like. In other examples, such as the example shown in <FIG>, the lower beam <NUM> may be inserted through an aperture (e.g., a bore) extending within the upper beam <NUM>. It can be appreciated the portion of the lower beam <NUM> extending within the aperture of the upper beam <NUM> may be fixedly attached to the upper beam <NUM> (via and adhesive, for example). In other instances, the lower beam <NUM> may be slidably coupled to the upper beam by passing the lower beam <NUM> through the aperture of the upper beam <NUM>.

<FIG> illustrates a portion of another implant delivery system <NUM> (the full implant delivery system <NUM> is shown in <FIG>) including an implant <NUM> coupled to an example frame <NUM> (e.g., implant deployment device, implant retainer). Various components of the implant delivery system <NUM> may be similar in form and function with the implant delivery system <NUM> described above. For example, as shown in <FIG>, the implant delivery system <NUM> may include an outer shaft <NUM> coupled to a handle <NUM>. Further, like the outer shaft <NUM> and delivery sheath <NUM> described herein, the distal end of the outer shaft <NUM> may include a delivery sheath <NUM>. The frame <NUM> may be positioned within the lumen of the delivery sheath <NUM> while being advanced to a target site. Further, it can be appreciated that actuation of an actuation member <NUM> coupled to the handle <NUM> may retract the outer shaft <NUM>, thereby deploying the frame <NUM> and implant <NUM> out of the delivery sheath <NUM>.

Like that described above with respect to the implant delivery system <NUM>, delivery of the implant delivery system <NUM> may include the insertion of the outer shaft <NUM> and delivery sheath <NUM> through an access site (e.g., incision) and advancement to a target site. During advancement to the target site, the detachable frame <NUM> and the implant <NUM> (in combination) may be wrapped and/or folded upon itself such that they are positioned within the lumen of the delivery sheath <NUM>. Further, the combination of the detachable frame <NUM> and the implant <NUM> may remain wrapped and/or folded within the lumen of the delivery sheath <NUM> until deployed from the delivery sheath <NUM>.

For example, after positioning the distal end of the delivery sheath <NUM> proximate the target site, a clinician may deploy the detachable frame <NUM> (in combination with the implant <NUM>) out of the lumen of the delivery sheath <NUM>, such as by retracting the outer shaft <NUM> and delivery sheath <NUM> and positioning the implant <NUM> and the frame <NUM> over the target site. As will be described in greater detail below, the frame <NUM> and the implant <NUM> may automatically expand to an open state when unconstrained by the delivery sheath <NUM>. Further, in some examples, the frame <NUM> may be "shape set" such that its deployed configuration may generally match the curvature of the humeral head. In other words, the frame <NUM> may expand to a substantially curved configuration which matches the curvature of the humeral head when unconstrained by the delivery sheath <NUM>.

As shown in <FIG>, the detachable frame <NUM> may include a body portion <NUM>. In some examples, the body portion <NUM> may resemble a square, rectangular, circular, ovular, or similarly shaped framework from which other members may extend. For example, the body portion <NUM> of the frame <NUM>-<NUM> may bear some resemblance to an elongated rectangle having a proximal portion and a distal portion. Further, the body portion <NUM> may include one or more apertures defined between struts of the body portion <NUM>. Additionally, <FIG> illustrates that the frame <NUM> may further include a connector leg <NUM> and a head portion <NUM>, which may be utilized to connect the frame <NUM> to other components (e.g., an inner shaft <NUM> and a tether <NUM> shown in <FIG>) of the implant delivery system <NUM>. It is noted that the inner shaft <NUM> is depicted in dashed lines and extending over a collar <NUM>, the details of which will be described in greater detail below. Additionally, <FIG> further illustrates that the frame <NUM> may include one or more attachment arms 264a/264c which may be utilized to releasably attach the implant <NUM> to the frame <NUM>.

It can be appreciated that the detachable frame <NUM> may be a monolithic structure formed of a superelastic metal material, such as nitinol. However, it is also contemplated that the detachable frame <NUM> may be constructed using alternative materials and/or manufacturing methodologies. For example, the frame <NUM>, or portions thereof, may be constructed from a polymeric material, a ceramic material and/or other various materials. Additionally, the frame <NUM> may be manufactured via an injection molding or alternative polymer manufacturing methodologies. Alternatively, the frame <NUM> may be formed through a <NUM>-D printing process, if desired. Further, different portions of the frame <NUM> (as described above, for example), may be made from a variety of materials and combined using alternative methodologies. For example, the attachment arms 264a/264c may be made from a polymer material and combined with a central frame member constructed from a metal material. Variations of combining different materials with different portions of the frame <NUM> are contemplated.

<FIG> further illustrates that the implant delivery system <NUM> described herein may include a tack member <NUM> designed to secure the delivery system <NUM> in place prior to a clinician affixing the implant <NUM> to the bone and/or tendon. For example, <FIG> illustrates a tack member <NUM> extending distally from a tack disk <NUM>. As shown in <FIG>, the tack member <NUM> may extend distally from the tack disk <NUM> and be substantially perpendicular to the implant <NUM> and/or frame <NUM>.

In some instances, the tack member <NUM> may resemble a cylindrical pin or rod extending away from the frame <NUM>. Additionally, the tack member <NUM> may be designed to be rigid enough to be pounded and/or inserted into bone. For example, in some instances, a clinician may apply a force to a proximal portion of the implant delivery system <NUM> (e.g., on the proximal end of the inner shaft <NUM>) such that the tack member <NUM> may be "hammered" into a body structure (e.g., bone). As shown in <FIG>, the tack member <NUM> may include a tapered distal tip, which may be a sharpened or blunt tapered distal tip in some instances. <FIG> illustrates that the tack member <NUM> may extend through one of the apertures <NUM> defined in the body portion <NUM> when the frame <NUM> is in the deployed configuration of <FIG>. Furthermore, the tack member <NUM> may extend through the implant <NUM> when attached to the frame <NUM> in the deployed configuration (as shown in <FIG>).

<FIG> further illustrates that the implant delivery system <NUM> may further include a tether <NUM> secured to the proximal end of the tack member <NUM>, such as coupled to a tack disk <NUM>, which in turn may be coupled to or formed as a portion of the tack member <NUM>. Therefore, the tack member <NUM> may be secured to the tether <NUM> via the tack disk <NUM>. Accordingly, after the tack member <NUM> has been inserted into bone, retraction of the tether <NUM> may pull on the tack member <NUM>, thereby releasing it from a target site (e.g., a bone).

Further, the frame <NUM> may also be coupled to the tether <NUM> via a connection, such as the combination of the tack disk <NUM> and a collar <NUM>. It can be appreciated that both the tack disk <NUM> and the collar <NUM> may be fixedly attached to the tether <NUM>. Additionally, as discussed above, <FIG> illustrates that the tack disk <NUM> may be coupled to both the head portion <NUM> and the connector leg 264b of the frame <NUM>. In particular, the head portion <NUM> and the connector leg 264b may be "sandwiched" between a distal facing surface or rim of the collar <NUM> and a proximal facing surface or rim of the tack disk <NUM>. In other words, the head portion <NUM> and the connector leg 264b of the frame <NUM> may be constrained between the collar <NUM> and the tack disk <NUM>. Therefore, the frame <NUM> may be coupled to the tether <NUM> via being sandwiched between the collar <NUM> and the tack disk <NUM>.

As described above, the implant delivery system <NUM> may include an inner shaft <NUM> which may extend within the lumen of the outer shaft <NUM> and be longitudinally movable relative thereto. In some examples, the proximal end of the inner shaft <NUM> and/or the outer shaft <NUM> may be coupled to the handle <NUM>. Further, the distal end of the inner shaft <NUM> may be designed to engage the collar <NUM>. For example, the lumen of the inner shaft <NUM> may be designed to mate with the outer profile of the collar <NUM>, thereby permitting the distal end of the inner shaft <NUM> to extend over the collar <NUM>. Accordingly, manipulation of the inner shaft <NUM> may impart movement to the collar <NUM> (and consequently, the frame <NUM>). It can be appreciated that the handle <NUM> may be utilized to manipulate the inner shaft <NUM> relative to the outer shaft <NUM> and the delivery sheath <NUM>. For example, the handle <NUM> may be utilized to impart a rotational force to the inner shaft <NUM> and/or longitudinal movement of the inner shaft <NUM> relative to the outer shaft <NUM> and delivery sheath <NUM>. In some instances, the tether <NUM> may extend through the lumen of the inner shaft <NUM> proximally to the handle <NUM>. The frame <NUM> may be detachable from the inner shaft <NUM> such that the inner shaft <NUM>, the outer shaft <NUM> and handle <NUM> may be removed while the frame <NUM> may remain attached to the tether <NUM>.

As discussed above, <FIG> illustrates the entire example implant delivery system <NUM>. The implant delivery system <NUM> may include a handle <NUM>. <FIG> further illustrates the implant delivery system <NUM> includes the delivery sheath <NUM>, which my house the combination frame <NUM> and implant <NUM> (shown in <FIG>). <FIG> illustrates that the handle <NUM> may be attached to the delivery sheath <NUM> via an outer shaft <NUM>.

As discussed above, the delivery sheath <NUM> may surround the frame <NUM> and implant <NUM> when in a delivery configuration. In other words, the frame <NUM> and implant <NUM> may be contained in a collapsed, folded delivery configuration within the lumen of the delivery sheath <NUM> during delivery to a treatment site. For example, it can be appreciated that in a delivery configuration, the implant <NUM> may be attached to the frame <NUM>, whereby the implant <NUM> and frame <NUM> (together) may be folded and positioned within the delivery sheath <NUM>.

Additionally, it can be appreciated that retraction of the outer shaft <NUM> may release (e.g., deploy) the implant <NUM> and frame <NUM> from the delivery sheath <NUM>. In other words, the implant <NUM> and frame <NUM> may be positioned within the delivery sheath <NUM> as the outer shaft <NUM> is inserted into a patient's body and advanced toward a target site. After being positioned at the target site, the outer shaft <NUM>, and delivery sheath <NUM> secured thereto, may be retracted while the inner shaft <NUM> may be held stationary relative to the outer shaft <NUM>. As discussed above, retraction of the outer shaft <NUM> relative to the inner shaft <NUM> and frame <NUM> may retract the delivery sheath <NUM> relative thereto, which uncovers (e.g., releases) and deploys the implant <NUM> and the frame <NUM>.

<FIG> further illustrates that the handle <NUM> may include an actuation member <NUM> (e.g., trigger) positioned within a first circumferential recess <NUM> of a channel <NUM>. As will be described in greater detail below, actuation of the actuation member <NUM> (via translating the actuation member <NUM> within the channel <NUM>) may retract the outer shaft <NUM> relative to the inner shaft <NUM> and handle <NUM>. Additionally, it can be appreciated that the actuation member <NUM> may be fixedly secured to a proximal end of the outer shaft <NUM> (while a proximal end of the inner shaft <NUM> may be fixedly secured to the housing of the handle <NUM>). Accordingly, shifting the actuation member <NUM> from a position in which it is closer to the distal end <NUM> of the handle <NUM> to a position in which it is closer to the proximal end <NUM> of the handle <NUM> may retract the outer shaft <NUM> relative to the inner shaft <NUM>, which may also retract the delivery sheath <NUM>, thereby deploying the frame <NUM> and implant <NUM>.

<FIG> further illustrates the tether <NUM> extending out of the proximal end <NUM> of the handle <NUM>. It can be appreciated that to utilize the tether <NUM> to release the tack member <NUM>, the tether <NUM> should be accessible to the user. <FIG> illustrates the tether <NUM> extending from the tack member <NUM>, through the inner shaft <NUM> (which is positioned within the lumen of the outer shaft <NUM>), through the handle <NUM> to a position outside the handle <NUM> (e.g., through the handle <NUM> to a location proximal of the handle <NUM>). As discussed above, the tether <NUM> may also be secured to the frame <NUM>, such as via the combination of the collar <NUM> and tack disk <NUM>, or otherwise secured to the frame <NUM>, as described above.

<FIG> illustrates the actuation member <NUM> positioned within the recess <NUM> of the channel <NUM>. It can be appreciated that when positioned within the recess <NUM>, the actuation member <NUM> is prevented from shifting in a distal-to-proximal direction, thereby preventing an inadvertent deployment of the frame <NUM> and implant <NUM>. In other words, until a user chooses to rotate the actuation member <NUM> out of the recess <NUM> and slide the actuation member in a distal-to-proximal direction within the longitudinal channel <NUM>, the frame <NUM> and implant <NUM> will not deploy. This may be an important safety feature during operation of the implant delivery system <NUM>.

As described above, the tether <NUM> may be utilized to release the tack member <NUM> after the tack member <NUM> has been inserted into bone. It can be appreciated that pulling on the tether <NUM> requires the tether <NUM> to move freely relative to the handle <NUM>. However, in some instances, it may be desirable to clamp and secure the tether <NUM> relative to the handle <NUM> until a user opts to release it. Accordingly, in some examples, the delivery system <NUM> may include a tether clamp mechanism <NUM> (shown in <FIG>) which may clamp and secure the tether member <NUM> relative to the handle <NUM>. In some instances, further manipulation of the actuation member <NUM> after retracting the outer sheath <NUM> to expose the frame <NUM> and implant <NUM> may release or unclamp the tether member <NUM> from the handle <NUM>. For example, further manipulation of the actuation member <NUM> may cause the actuation member <NUM> to move the tether clamp mechanism <NUM> from a locked or engaged position to an unlocked of disengaged position to release the tether member <NUM>. In some instances, the actuation member <NUM> may be withdrawn proximally in a longitudinal direction (along the longitudinal axis) to retract the outer sheath <NUM>, and thereafter, further manipulation of the actuation member <NUM> in a circumferential direction (e.g., rotated about the longitudinal axis) may cause the actuation member <NUM> to move the tether clamp mechanism <NUM> from a locked or engaged position to an unlocked of disengaged position to release the tether member <NUM>. One possible configuration is further shown in <FIG>.

As described above, <FIG> illustrates the actuation member <NUM> has been rotated out of the recess <NUM> and has been translated in a proximal direction along the longitudinal channel <NUM> to a position in which it is approximately midway between the first recess <NUM> and the second recess <NUM>. Further, in the position illustrated in <FIG>, it can be appreciated that the outer shaft <NUM> has been retracted such that the implant <NUM> and frame <NUM> have been partially deployed out of the lumen of the delivery sheath <NUM>. <FIG> shows the implant <NUM> and frame <NUM> in a wrapped configuration prior to being fully expanded.

<FIG> illustrates a partially exploded view of the handle <NUM> shown in <FIG>. As described above, the actuation member <NUM> has been rotated out of the recess <NUM> and has been translated in a proximal direction along the channel <NUM> to a position in which it is approximately midway between the first recess <NUM> and the second recess <NUM>. <FIG> further illustrates the outer shaft <NUM> extending proximally from the delivery sheath <NUM> to the actuation member <NUM>. As discussed above, <FIG> further illustrates the tether <NUM> may extend from the tack member <NUM> (discussed above), through the lumen of the inner shaft <NUM> (extending through the outer shaft <NUM>), through an aperture <NUM> located in the actuation member <NUM>, through the tether clamp mechanism <NUM> and thereafter exit the proximal end of the handle <NUM>.

As discussed above, it can be appreciated that the tether clamp mechanism <NUM> may fixedly secure the tether <NUM> from relative longitudinal movement relative to the inner shaft <NUM>, the outer shaft <NUM> and the handle <NUM> when in a locked position. <FIG> illustrates that the tether clamp mechanism <NUM> may include a rotatable lever <NUM> positioned adjacent to a block component <NUM>. As will be described in greater detail below, the tether <NUM> may extend though the aperture <NUM> of the actuation member <NUM> and be juxtaposed along a surface of the block component <NUM>, such as rest along a v-shaped notch of the block component <NUM> before exiting the proximal end of the handle <NUM>.

Further, the lever <NUM> may be biased in a first position in which it pinches (e.g., locks, grips, holds, secures) the tether <NUM> against the surface of the block component <NUM> (e.g., within the v-shaped notch of the block component <NUM>). For example, the lever <NUM> may be coupled to a spring (or similar mechanism) which biases the lever <NUM> to a first position in which it pinches (e.g., locks, grips, holds, secures) the tether <NUM> against the surface of the block component <NUM> (e.g., within the v-shaped notch of the block component <NUM>). In other instances, the lever <NUM> may be flexible and be deflected which biases the lever <NUM> to a first position in which it pinches (e.g., locks, grips, holds, secures) the tether <NUM> against the surface of the block component <NUM> (e.g., within the v-shaped notch of the block component <NUM>) Accordingly, and as will be described in further detail below, the lever <NUM> may be rotated or otherwise moved away from the block component <NUM> to free the tether <NUM>. Rotation of the lever <NUM> may be accomplished using the actuation member <NUM>, as described below.

<FIG> illustrate a first step in utilizing the actuation member <NUM> to rotate the lever <NUM> relative to the block component <NUM>, thereby freeing the tether <NUM>. Specifically, <FIG> illustrates that the actuation member <NUM> has been translated proximally along the channel <NUM> to a position in which it is aligned with the second circumferential recess <NUM>. It can be appreciated that the proximal translation of the actuation member <NUM> along the longitudinal axis may retract the outer shaft <NUM> such that the implant <NUM> and frame <NUM> are fully deployed out of the delivery sheath <NUM> (as shown in <FIG>). Further, <FIG> illustrates a portion of the inner shaft <NUM> positioned distal to the delivery sheath <NUM>, whereby the inner shaft <NUM> is coupled to the fully expanded frame <NUM> and implant <NUM>. <FIG> further illustrates the tether <NUM> extending through the inner shaft <NUM>. As discussed above, the tether <NUM> may be coupled to the tack member <NUM>.

<FIG> illustrates a partially exploded view of the handle <NUM> shown in <FIG>. As described above, <FIG> illustrates that the actuation member <NUM> has been translated proximally along the channel <NUM> to a position in which it is aligned with the second recess <NUM>. Further, <FIG> illustrates that the actuation member <NUM> may include an engagement feature, such as a projection <NUM> (e.g., arm, fin) extending proximally away from the proximal end of the actuation member <NUM>. As shown in <FIG>, prior to being rotated about the longitudinal axis into the second recess <NUM>, the engagement feature or projection <NUM> may be aligned with the lever <NUM>. In other words, prior to being rotated into the second recess <NUM>, the engagement feature or projection <NUM> may extend over the upper surface of the block component <NUM> and between the lever <NUM> and the inner surface of the handle <NUM>.

For example, <FIG> illustrates an end view of the actuation member <NUM>, lever <NUM> and block component <NUM> shown in <FIG>. As described above, <FIG> illustrates the tether <NUM> positioned within the v-notch <NUM> of the block component <NUM>. Additionally, <FIG> illustrates that the lever <NUM> may include a first end <NUM> which is biased to pinch the tether <NUM> within the v-notch <NUM> of the block component <NUM> or otherwise against a surface of the block component <NUM>. Further, the lever <NUM> may also include a second end <NUM> which may be positioned adjacent to the projection <NUM> of the actuation member <NUM>. As described above with respect to <FIG>, prior to being rotated into the second recess <NUM>, the projection <NUM> may extend over the upper surface <NUM> of the block component <NUM> and between the second end <NUM> of the lever <NUM> and the inner surface of the handle <NUM>.

<FIG> illustrate a next step in actuating the actuation member <NUM> to rotate the lever <NUM> relative to the block component <NUM>, thereby freeing the tether <NUM>. Specifically, <FIG> illustrates the actuation member <NUM> being rotated about the longitudinal axis into the second recess <NUM>. It can be appreciated that as the actuation member <NUM> is being rotated into the second recess <NUM>, the outer shaft <NUM> remains retracted such that the implant <NUM> and frame <NUM> are fully deployed out of the delivery sheath <NUM>. <FIG> further illustrates the tether <NUM> extending through the inner shaft <NUM>. AS the actuation member <NUM> is rotated, the engagement feature (e.g., the projection <NUM> engages the lever <NUM> and causes the lever <NUM> to move from the engaged or locked position to the disengaged or unlocked position. Accordingly, in the configuration shown in <FIG>, after the actuation member <NUM> is rotated into the second recess <NUM> and moved the lever <NUM> to the unlocked position, the tether <NUM> is free to move relative to the inner shaft <NUM>, the outer shaft <NUM> and the handle <NUM>.

<FIG> illustrates an end view of the position of the actuation member <NUM>, the lever <NUM> and block component <NUM> shown in <FIG>. Specifically, <FIG> illustrates an end view of the actuation member <NUM> rotated relative to the block component <NUM>. Rotation of the actuation member <NUM> is depicted by the arrow <NUM>. It can be appreciated from <FIG> that the rotation of the actuation member <NUM> causes the projection <NUM> to engage the second end <NUM> of the lever <NUM>. Further, the engagement of the projection <NUM> with the second end <NUM> of the lever <NUM> pivots the lever <NUM> about the pivot point <NUM>, thereby rotating the first end <NUM> of the lever <NUM> away from the tether <NUM>. In this configuration, the tether <NUM> is free to move relative to the inner shaft <NUM>, the outer shaft <NUM> and the handle <NUM>.

<FIG> illustrates another an implant delivery system <NUM>. It can be appreciated that the implant delivery system <NUM> may be similar in form and function to other implant delivery systems described herein. It can be further appreciated that the configuration of the delivery system <NUM> shown in <FIG> may be similar to the delivery system <NUM> shown in <FIG>.

For example, the implant delivery system <NUM> may include an outer shaft <NUM> coupled to a handle <NUM>. Further, the distal end of the outer shaft <NUM> may include a delivery sheath <NUM>. Like other delivery systems described herein, a frame <NUM> and an implant <NUM> may be positioned within the lumen of the delivery sheath <NUM> while being tracked to a target site. Further, as shown in <FIG>, it can be appreciated that the actuation of the handle <NUM> may retract the outer shaft <NUM> to deploy the frame <NUM> and implant <NUM> out of the delivery sheath <NUM>. Additionally, <FIG> further illustrates a tether <NUM> extending from a tack member <NUM>, through the lumen of the inner shaft <NUM> (which extends through the lumen of the outer shaft <NUM>), through an aperture located in the actuation member <NUM>, through a tether clamp mechanism <NUM> and thereafter exit the proximal end of the handle <NUM>. Similar to the embodiment above, further manipulation of the actuation member <NUM> after retracting the outer sheath <NUM> to expose the frame <NUM> and implant <NUM> may release or unclamp the tether member <NUM> from the handle <NUM>. For example, further manipulation of the actuation member <NUM> may cause the actuation member <NUM> to move the tether clamp mechanism <NUM> from a locked or engaged position to an unlocked of disengaged position to release the tether member <NUM>. In some instances, the actuation member <NUM> may be withdrawn proximally in a longitudinal direction (along the longitudinal axis) to retract the outer sheath <NUM>, and thereafter, further manipulation of the actuation member <NUM> in a circumferential direction (e.g., rotated about the longitudinal axis) may cause the actuation member <NUM> to move the tether clamp mechanism <NUM> from a locked or engaged position to an unlocked of disengaged position to release the tether member <NUM>.

<FIG> illustrates an actuation member <NUM> positioned adjacent to the tether clamp mechanism <NUM>. Further, <FIG> illustrates that the actuation member <NUM> may include an engagement member, such as a projection <NUM> positioned adjacent to the tether clamp mechanism <NUM>, configured to engage a surface of the tether clamp mechanism <NUM>. Like the implant delivery system <NUM> described above, it can be appreciated that rotation of the actuation member <NUM> may engage the projection <NUM> with the tether clamp mechanism <NUM> to move the tether clamp mechanism from an engaged or locked position to a disengaged or unlocked position to free the tether <NUM>.

For example, <FIG> illustrates an end view of the actuation member <NUM> relative to the tether clamp mechanism <NUM>. <FIG> further illustrates the tether <NUM> positioned between a moving (e.g., sliding) component or block <NUM> (e.g., block, wedge, etc.) and a fixed component <NUM> (e.g., block, wedge, etc.) of the tether clamp mechanism <NUM>. In some instances, the fixed component <NUM> may be an extension of the handle <NUM> (e.g., the fixed component may be a monolithic structure with the handle <NUM> and extend away from and inner surface thereof). It can be appreciated that the sliding component <NUM> may be free to move relative to the fixed component <NUM>. For example, the moving or sliding component <NUM> may be free to shift closer to or away from the fixed component <NUM>.

Additionally, <FIG> illustrates that the tether lock mechanism <NUM> may include a biasing member or spring <NUM>. The spring <NUM> may include a first end coupled to the moving or sliding component <NUM> and a second end which may be coupled to an inner surface of the handle <NUM>, for example. Accordingly, it can be appreciated that the spring <NUM> may exert a force of the moving or sliding component <NUM> which biases the sliding component <NUM> toward the fixed component <NUM> to thereby press the tether member <NUM> therebetween. It can be further appreciated that the force imparted by the spring <NUM> to the moving or sliding component <NUM> may pinch (e.g., secure, lock, hold) the tether <NUM> between the moving or sliding component <NUM> and the fixed component <NUM>. Additionally, <FIG> illustrates that the projection <NUM> of the actuation member <NUM> may be aligned with the moving or sliding component <NUM>. Like that described above with respect to the implant delivery system <NUM>, prior to rotation of the actuation member <NUM>, the tether <NUM> may be pinched or otherwise pressed between the moving or sliding component <NUM> and the fixed component <NUM>, and may not be free to move relative to the inner shaft <NUM>, the outer shaft <NUM> or the handle <NUM>.

<FIG> illustrates the actuation member <NUM> rotating relative to the moving or sliding member <NUM> and the fixed component <NUM>. Rotation of the actuation member <NUM> is depicted by the arrow <NUM>. It can be appreciated that the actuation member <NUM> may be rotated about the longitudinal axis into a second recess of the handle <NUM>. It can be further appreciated that as the actuation member <NUM> is rotated, the engagement feature or projection <NUM> of the actuation member <NUM> may engage the sliding component <NUM>. Further, rotation of the projection <NUM> may engage the projection <NUM> with the moving or sliding component <NUM> and move the moving or sliding component <NUM> away from the fixed component <NUM>, thereby freeing the tether <NUM>. Accordingly, in the configuration shown in <FIG>, after the actuation member <NUM> is rotated to the disengaged or unlocked position, the tether <NUM> is free to move relative to the inner shaft <NUM>, the outer shaft <NUM> and the handle <NUM>. However, it can be further appreciated that the outer shaft <NUM> remains retracted such that the implant <NUM> and the frame <NUM> are fully deployed out of the delivery sheath <NUM> when the actuation member <NUM> is rotated into the recess <NUM>.

<FIG> illustrates another an implant delivery system <NUM>. It can be appreciated that the components of the implant delivery system <NUM> may be similar in form and function with other implant delivery systems described herein.

For example, the implant delivery system <NUM> may include an outer shaft <NUM> coupled to an actuation member <NUM>, whereby the actuation member <NUM> is coupled to a handle <NUM>. Further, the distal end of the outer shaft <NUM> may include a delivery sheath <NUM>. Like other delivery systems described herein, a frame <NUM> and implant <NUM> may be positioned within the lumen of the delivery sheath <NUM> while being tracked to a target site. Further, as shown in <FIG>, proximal translation <NUM> of the actuation member <NUM> may retract the outer shaft <NUM> to deploy the frame <NUM> and implant <NUM> out of the delivery sheath <NUM>. Like <FIG> described above with respect to the implant delivery system <NUM>, <FIG> illustrates that the actuation member <NUM> has been translated in a proximal direction along the handle <NUM> to a position in which it is approximately midway between the first recess <NUM> and the second recess <NUM> of the handle <NUM>. Further, in the position illustrated in <FIG>, it can be appreciated that the outer shaft <NUM> has been retracted such that the implant <NUM> and frame <NUM> have been partially deployed out of the lumen of the delivery sheath <NUM>.

<FIG> further illustrates that the implant delivery system <NUM> may also include a tether clamp mechanism <NUM> positioned proximal to the actuation member <NUM>. The tether clamp mechanism <NUM> may include an engagement feature, such as a projection <NUM>, which is designed to engage (e.g., insert into) a mating engagement feature, such as an aperture <NUM>, located on the actuation member <NUM>. While <FIG> illustrates that the tether clamp mechanism <NUM> may include a projection <NUM> designed to engage the aperture of the <NUM> of the actuation member <NUM>, it is also contemplated that, in other examples, the actuation member <NUM> may include a projection designed to engage an aperture located on the tether clamp mechanism <NUM>, for example. <FIG> further illustrates that the tether member <NUM> may extend through a portion of the tether clamp mechanism <NUM>, such as between adjacent sidewalls of the tether clamp mechanism <NUM>.

It can be appreciated that the tether clamp mechanism <NUM> may be utilized to fixedly secure the tether <NUM> from relative longitudinal movement relative to the inner shaft <NUM>, the outer shaft <NUM> and the handle <NUM>, when in a locked position. As will be described in greater detail below, the tether <NUM> may extend though the aperture of the tether clamp mechanism <NUM> before exiting the proximal end of the handle <NUM>. Further, the tether clamp mechanism <NUM> may be biased in a first position in which it presses or pinches (e.g., locks, grips, holds) the tether <NUM> within the aperture of the tether clamp mechanism <NUM>. Accordingly, and as will be described in further detail below, a portion of the tether clamp mechanism <NUM> may be moved (e.g., rotated) to free the tether <NUM>. Rotation of the tether clamp mechanism <NUM> may be accomplished using the actuation member <NUM>, as described below.

<FIG> illustrates the implant delivery device <NUM> shown in <FIG> whereby the actuation member <NUM> has been translated proximally to a position in which it is aligned with the second circumferential recess <NUM>. Accordingly, it can be appreciated from <FIG> that the outer shaft <NUM> has been retracted such that the implant <NUM> and the frame <NUM> are fully deployed out of the delivery sheath <NUM>. <FIG> further illustrates the tether <NUM> may extend from the tack member <NUM>, through the lumen of the inner shaft <NUM> (extending through the outer shaft <NUM>), through an aperture located in the actuation member <NUM>, through the tether clamp mechanism <NUM> and thereafter exit the proximal end of the handle <NUM>.

Further, <FIG> further illustrates that the actuation member <NUM> has engaged the tether clamp mechanism <NUM> in the retracted position, as described above. It can be appreciated that in the configuration shown in <FIG>, the engagement feature (e.g., projection <NUM>) of the tether clamp mechanism <NUM> has engaged the mating engagement feature of the actuation member <NUM> (e.g., has been inserted into the aperture <NUM> of the actuation member <NUM>). In the configuration shown in <FIG>, the tether member <NUM> may be pressed or pinched (e.g., locked, secured, held) within an aperture of the tether clamp mechanism <NUM>. As described above, a portion of the tether clamp mechanism <NUM> may be rotated to free the tether <NUM>. For example, a first side wall of the tether clamp mechanism <NUM> may be pivoted or deflected relative to an adjacent second side wall of the tether clamp mechanism <NUM> to widen a portion of the aperture through while the tether <NUM> extends. Rotation of the tether clamp mechanism <NUM> may be accomplished using the actuation member <NUM>, as described below.

For example, <FIG> illustrates an end view of the position of the actuation member <NUM> relative to the tether clamp mechanism <NUM> shown in <FIG>. <FIG> further illustrates that the tether clamp mechanism <NUM> may include a first side wall <NUM> spaced away from a second side wall <NUM>, whereby the tether <NUM> may be positioned between the first side wall <NUM> and the second side wall <NUM>. Additionally, <FIG> illustrates that a bottom portion of the tether clamp mechanism <NUM> may connect the first side wall <NUM> to the second side <NUM> and may also be secured to a shelf <NUM>. The shelf <NUM> may extend from an inner surface of the handle <NUM>.

It can be appreciated that when positioned between the first side wall <NUM> and the second side wall <NUM>, the tether <NUM> may be in a locked position, whereby the tether <NUM> may not be able to move relative to the inner shaft <NUM>, the outer shaft <NUM> or the handle <NUM>. Further, it can be appreciated that rotation of the first side wall <NUM> away from the second side wall <NUM> may free the tether <NUM> and permit it to move relative to the inner shaft <NUM>, the outer shaft <NUM> or the handle <NUM>.

Additionally, <FIG> illustrates that the tether clamp mechanism <NUM> may include an angled projection <NUM> which is designed to engage a first end <NUM> of the second side wall <NUM>. Engagement of the projection <NUM> with the first end <NUM> of the second side wall <NUM> may provide an interference fit between the projection <NUM> and the first end <NUM> of the second side wall <NUM> which may need to be overcome to permit the first side wall <NUM> to rotate away from the second side wall <NUM>. Additionally, <FIG> illustrates the aperture <NUM> of the actuation member <NUM>, which may be designed to accept the projection <NUM> of the tether clamp mechanism <NUM>, as described above.

<FIG> illustrates the actuation member <NUM> rotating relative to the handle <NUM>. Rotation of the actuation member <NUM> is depicted by the arrow <NUM> in <FIG>. It can be appreciated that after withdrawing the actuation member <NUM> proximally to deploy the implant <NUM>, the actuation member <NUM> may be rotated into a second recess <NUM> of the handle <NUM>. It can be further appreciated that as the actuation member <NUM> is rotated, a portion of the tether clamp mechanism <NUM> may also rotate along with the actuation member <NUM> (as the tether clamp mechanism <NUM> is engaged with the actuation member <NUM> via the projection <NUM> of the tether clamp mechanism <NUM> extending into the aperture <NUM> of the actuation member <NUM>). For example, <FIG> illustrates the first side wall <NUM> rotating away from the second side wall <NUM> as the actuation member <NUM> rotates into the second recess <NUM> of the handle <NUM>. However, as discussed above, in order for the tether clamp mechanism <NUM> to rotate (along with the actuation member <NUM>), the interference force established between the angled projection <NUM> and the first end <NUM> of the second side wall <NUM> may need to be overcome. However, if the interference force is overcome, and the tether clamp mechanism <NUM> is rotated, the tether <NUM> may be free to move relative to the inner shaft <NUM>, the outer shaft <NUM> and the handle <NUM>. It can be further appreciated that the outer shaft <NUM> remains retracted such that the implant <NUM> and the frame <NUM> are fully deployed out of the delivery sheath <NUM> while the actuation member <NUM> and the tether clamp mechanism <NUM> are rotated.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure.

Claim 1:
An implant delivery system (<NUM>), the implant delivery system comprising:
an outer shaft (<NUM>) having a proximal end, a distal end and lumen extending therein;
an inner shaft (<NUM>) including a proximal end and a distal end, the inner shaft (<NUM>) extending within a least a portion of the lumen of the outer shaft (<NUM>);
a yoke (<NUM>) coupled to the distal end of the inner shaft (<NUM>); and
an implant retainer (<NUM>) coupled to the yoke (<NUM>); the implant retainer (<NUM>) is configured to capture an implant characterised in that the implant retainer (<NUM>) is configured to pivot relative to the yoke (<NUM>) by rotating about a rotational axis extending perpendicular to a longitudinal axis of the inner shaft (<NUM>).