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. Adequate procedures do not exist for repairing a partial thickness tear of less than <NUM>% in the supraspinatus tendon. Current procedures attempt to alleviate impingement or make room for movement of the tendon to prevent further damage and relieve discomfort but do not repair or strengthen the tendon. Use of the still damaged tendon can lead to further damage or injury. 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 comprising a delivery shaft and a cartridge for holding an implant is known from the document <CIT>.

The present invention relates to an implant delivery system for delivering a tendon implant as set forth in the appended claims. The method of using the delivery system and the method of implanting the implant do not form part of the invention.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes an implant delivery system having a delivery shaft including a proximal portion and a distal portion and a detachable frame coupled to the distal portion of the delivery shaft. The detachable frame includes a body portion and a plurality of attachment arms extending away from the body portion. The plurality of attachment arms are configured to be attached to an implant and the detachable frame is configured to detach from the delivery shaft in vivo.

Alternatively or additionally to any of the embodiments above, wherein the frame further comprises a first aperture configured to couple with the distal portion of the delivery shaft.

Alternatively or additionally to any of the embodiments above, wherein the distal portion of the delivery shaft is coupled to a connection member, and wherein the connection member is configured to engage with the first aperture.

Alternatively or additionally to any of the embodiments above, the frame further comprises a second aperture, and wherein the distal portion of the delivery shaft is coupled to a connection member, and wherein the connection member is configured to engage with the second aperture.

Alternatively or additionally to any of the embodiments above, the first aperture is located in an extension member of the frame, the second aperture is located in a head portion of the frame, and a surface of the extension member is configured to be positioned against a surface of the head portion.

Alternatively or additionally to any of the embodiments above, wherein the first aperture and the second aperture are coaxial.

Alternatively or additionally to any of the embodiments above, wherein the connection member is configured to disengage from the delivery shaft, and wherein the connection member is configured to remain engaged to the frame after disengaging from the delivery shaft.

Alternatively or additionally to any of the embodiments above, wherein the delivery system includes a tack member.

Alternatively or additionally to any of the embodiments above, wherein the tack member is stationary with respect to the connection member.

Alternatively or additionally to any of the embodiments above, wherein the tack member can translate with respect to the connection member.

Alternatively or additionally to any of the embodiments above, wherein the delivery system includes a tether attached to the connection member, the frame, or both.

Alternatively or additionally to any of the embodiments above, wherein the tether extends within a lumen of the delivery shaft while the delivery shaft is attached to the frame, and wherein the tether remains connected to the frame when the delivery shaft is detached from the frame.

Alternatively or additionally to any of the embodiments above, wherein the frame includes a first surface facing an implant, and wherein the first surface is configured to shift from a convex configuration to a concave configuration.

Alternatively or additionally to any of the embodiments above, wherein each of the plurality of attachment arms include one or more attachment channels extending from a first surface of the attachment arm to a second surface of the attachment arm.

Alternatively or additionally to any of the embodiments above, further comprising an implant coupled to the frame via one or more attachment members.

Alternatively or additionally to any of the embodiments above, wherein the one or more attachment members extends through the one or more attachment channels on one or more of the plurality of attachment arms.

Alternatively or additionally to any of the embodiments above, wherein a locking member disposed along one of the plurality of attachment arms.

Alternatively or additionally to any of the embodiments above, wherein the locking member includes a first position in which the locking member is positioned away from the one or more attachment members and a second position in which the locking member contacts the one or more attachment members, and wherein the locking member is configured to shift from the first position to the second position.

Alternatively or additionally to any of the embodiments above, wherein locking member is slidably disposed along one of the plurality of attachment arms.

Alternatively or additionally to any of the embodiments above, wherein the implant includes a first surface facing the frame and a second surface facing away from the frame, and wherein each attachment member extends from the respective attachment arm through the first surface of the implant to the second surface of the implant.

Alternatively or additionally to any of the embodiments above, wherein the frame is configured to detach from the implant by removing the one or more attachment members from the implant.

An example method for delivering an implant to repair a tendon includes advancing an implant repair system to a target site. The implant repair system includes a delivery shaft including a proximal portion and a distal portion and a detachable frame coupled to the distal portion of the delivery shaft, wherein the detachable frame includes a body portion and a plurality of attachment arms extending away from the body portion. The implant repair system further includes an implant attached to the attachment arms. The method further includes positioning the implant adjacent the target site, detaching the delivery shaft from the frame in vivo and thereafter affixing the implant to the target site.

Alternatively or additionally to any of the embodiments above, wherein the implant repair system further comprises a connection member, the connection member coupled between a distal end of the delivery shaft and the frame, and wherein detaching the delivery shaft from the frame includes disengaging the connection member from the distal end of the delivery shaft.

Alternatively or additionally to any of the embodiments above, wherein the implant repair system further comprises a tack extending from a distal end of the connection member, and wherein positioning the implant adjacent the target site includes anchoring the tack into the target site.

Alternatively or additionally to any of the embodiments above, wherein the method further comprises withdrawing the frame from the target site after affixing the implant to the target site, and wherein withdrawing the frame from the target site includes retracting a tether coupled to the frame.

Another example method for delivering a tendon repair implant to a target site includes advancing an implant repair system to a target site. The implant repair system includes a delivery shaft including a proximal portion and a distal portion and a detachable frame coupled to the distal portion of the delivery shaft, wherein the detachable frame includes a body portion and a plurality of attachment arms extending away from the body portion. The delivery system further includes an implant attached to the attachment arms. The method further includes positioning the implant adjacent the target site, wherein positioning the implant includes positioning a first end of the implant adjacent a bone and positioning a second end of the implant adjacent a tendon. The method further includes attaching the implant to the target site, wherein attaching the implant includes affixing the first end of the implant to the bone prior to affixing the second end of the implant to the tendon.

A method of assembling an implant delivery system includes positioning a frame member adjacent an implant, wherein the frame member includes: a plurality of attachment arms extending away from the frame member, one or more attachment channels disposed along at least one of the attachment arms and one or more locking members disposed along at least one of the attachment arms. The method further includes inserting an attachment member through the implant and at least partially into the one or more attachment channels and shifting the one or more locking members from a first position in which the locking members are free from the attachment member to a second position in which the locking members compress the attachment member against the attachment arm.

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. Current repair procedures may attempt to alleviate impingement or make room for movement of the tendon to prevent further damage and relieve discomfort but do not repair or strengthen the tendon. 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. 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 a cross-sectional view of a shoulder <NUM> including an example implant <NUM>. Shoulder <NUM> further shows a head <NUM> of humerus <NUM> mating with a glenoid fossa <NUM> of scapula <NUM>. The glenoid fossa <NUM> comprises a shallow depression in scapula <NUM>. A supraspinatus tendon <NUM> is also shown. These muscles (along with others) control the movement of humerus <NUM> relative to scapula <NUM>. A distal tendon <NUM> of supraspinatus tendon <NUM> meets humerus <NUM> at an insertion point <NUM>.

In <FIG>, tendon <NUM> includes a damaged portion <NUM> located near insertion point <NUM>. Damaged portion <NUM> includes a tear <NUM> extending partially through tendon <NUM>. 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 that the tendon repair implant <NUM> has been placed over the partial thickness tear <NUM>. In this example, 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.

In some instances, delivery of an 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 target implant site. After creating this "access site," the physician may insert an implant delivery system through the access site and position the distal end of the implant delivery system adjacent the target implant site. The physician may then manipulate the implant delivery system to deploy an implant out of a delivery sheath adjacent the target implant site.

For example, <FIG> provides a perspective view of an implant delivery system <NUM> extending through the shoulder <NUM> of a patient. <FIG> shows implant delivery system <NUM> deployed adjacent a target site (e.g., a tear in the supraspinatus tendon). In at least some embodiments, implant delivery system <NUM> comprises a sheath member <NUM> (e.g., a cannula) including a proximal portion (not shown), a distal portion <NUM> and a lumen extending within at least a portion of cannula <NUM>. Further, implant delivery system <NUM> may include a delivery shaft <NUM> extending within the lumen of sheath member <NUM> and longitudinally movable relative thereto.

Delivery shaft <NUM> may include a proximal portion (not shown) extending out of the proximal portion of sheath member <NUM> and/or otherwise manipulatable relative to sheath member <NUM> by a user. Additionally, in some examples the proximal portion of delivery shaft <NUM> and/o or sheath member <NUM> may be coupled to a handle member (not shown). The handle member may be utilized to manipulate delivery shaft <NUM>. For example, the handle member may be utilized to impart a rotational force to delivery shaft <NUM>.

In addition, delivery shaft <NUM> may include a distal portion <NUM> extending out of the distal portion <NUM> of sheath member <NUM>. Further, delivery shaft <NUM> may include a lumen extending therein. The lumen of delivery shaft <NUM> may extend along a portion or the entire length delivery shaft <NUM> (e.g., from distal portion <NUM> to the proximal portion of delivery shaft <NUM>).

Delivery system <NUM> may further include a detachable frame member <NUM> attached to the distal portion <NUM> of the delivery shaft <NUM>. As shown in <FIG>, detachable frame <NUM> may be attached to an implant <NUM> (e.g., a sheet-like implant). For purposes of the discussion herein, the combined structure including frame <NUM> and implant <NUM> may be defined as having a proximal end <NUM> and a distal end <NUM> as illustrated in <FIG>.

When initially positioning the frame <NUM> and implant <NUM> adjacent a target site, a clinician may orient the frame <NUM> and implant <NUM> (for example, via a handle member attached to a proximal portion of the delivery shaft <NUM>) such that the proximal portion <NUM> may be adjacent (e.g., overlaid) on a portion of the humerus (e.g., on the bone), while the distal portion <NUM> of the frame <NUM> and implant <NUM> may overlay the tendon <NUM>.

As described above, delivery of implant delivery system <NUM> may include the insertion of delivery sheath <NUM> through an access site (e.g., incision) and advancement to a target site. After positioning the distal end <NUM> of 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 located within and along the distal portion <NUM> of the delivery sheath <NUM>, such as by retracting delivery sheath <NUM> relative to delivery shaft <NUM> and frame <NUM>, and positioning implant <NUM> and frame <NUM> over the target site.

Prior to deployment, the detachable frame <NUM> and implant <NUM> combination may be contained (e.g., housed) within the lumen of delivery sheath <NUM> for subsequent deployment distally out distal opening of delivery sheath <NUM>. As will be described in greater detail below, the combination of detachable frame <NUM> and implant <NUM> may wrap and/or fold upon itself such that it may be positioned within the lumen of the delivery sheath <NUM>. Alternatively, detachable frame <NUM> and implant <NUM> may warp and/or fold around implant delivery shaft <NUM> while disposed within delivery sheath <NUM>.

<FIG> shows an example detachable frame member <NUM> attached to example implant <NUM>. As stated above with reference to <FIG>, detachable frame member <NUM> and implant <NUM> may have a proximal portion <NUM> which, for purposes of discussion herein, may be adjacent delivery shaft <NUM> and be configured to be positioned adjacent humerus <NUM>. Further, detachable frame member <NUM> and implant <NUM> may have a distal portion <NUM> which, for purposes of discussion herein, may extend away from deliver shaft <NUM> and be configured to be positioned adjacent tendon <NUM>.

<FIG> further shows fastening regions <NUM> located at various positions within implant <NUM>. As shown in <FIG>, the fastening regions <NUM> are positioned at locations which are free from the structure of frame member <NUM>. In other words, the shape of frame <NUM> may be designed to specifically permit fastening implant <NUM> to the anatomy at locations <NUM>. For example, a clinician may staple implant <NUM> to the anatomy at locations <NUM>.

<FIG> shows an example detachable frame member <NUM>. As shown in <FIG>, frame member <NUM> may include a body portion <NUM>. In some examples, body portion <NUM> may be understood to define a circular, ovular, or similar shaped framework from which other members may extend. For example, body portion <NUM> of frame <NUM> may bear some resemblance to an elongated oval having a proximal portion <NUM> and a distal portion <NUM>. Body portion <NUM> may include one or more apertures <NUM>. Further, frame <NUM> may include a head portion <NUM> positioned within and/or extending away from the proximal portion <NUM>. Head portion <NUM> may include an aperture <NUM>.

As shown in <FIG>, detachable frame <NUM> may include one or more attachment arms <NUM> extending away from body portion <NUM>. Each respective attachment arm <NUM> may include a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> of each of the attachment arms <NUM> may be rigidly attached to body portion <NUM>, while the distal portion <NUM> may be a free end of the attachment arm <NUM> spaced away from body portion <NUM>. In some examples (such as that shown in <FIG>), attachment arms <NUM> and head portion <NUM> may form a monolithic structure with body portion <NUM>. In other words, in some examples body portion <NUM>, head portion <NUM> and attachment arms <NUM> may be formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structure from a single piece of material. However, the above discussion is not intended to be limiting. Rather, it is contemplated that detachable frame <NUM> may be constructed using alternative materials and/or manufacturing methodologies. For example, frame <NUM>, or portions thereof, may be constructed from a polymeric material, a ceramic material and/or other various materials. Additionally, frame <NUM> may be manufactured via an injection molding or alternative polymer manufacturing methodologies. Alternatively, frame <NUM> may be formed through a <NUM>-D printing process, if desired. Further, different portions of frame <NUM> (as described above, for example), may be made from a variety of materials and combined using alternative methodologies. For example, attachment arms <NUM> may be made from a polymer material and combined with a central frame member constructed from a metal. Variations of combining different materials with different portions of frame <NUM> are contemplated.

<FIG> further illustrates that attachment arms <NUM> may include a variety of shapes. For example, in some instances, attachment arms <NUM> may include a bow and/or general curvilinear shape (such as that shown in the attachment arm <NUM> closest to head portion <NUM>). In other examples, an attachment arm <NUM> may include additional features, such as the circular portion <NUM> positioned along the attachment arm <NUM> (as shown in attachment arm <NUM> located farthest from head portion <NUM>).

In some examples, frame <NUM> may include a variety of shapes and/or geometric arrangements. For example, while the above discussion has focused on the shape of frame <NUM> shown in <FIG>, it is not intended to be limiting. For example, frame <NUM> may include one or more stiffening members <NUM> extending throughout frame <NUM>. Further, stiffening members <NUM> may be arranged within frame <NUM> (e.g., within body portion <NUM>) such that they create one or more apertures <NUM>. The number, shape, configuration and/or arrangement of stiffening members <NUM> and/or apertures <NUM> may depend on the particular performance characteristics desired to be imparted to detachable frame <NUM>. For example, additional stiffening members <NUM> may be added to frame <NUM> to provide increased stiffness to frame <NUM>. In other instances, stiffening members <NUM> may take on particular geometries that increase stiffness or flexibility in a particular direction while decreasing stiffness or flexibility in a different direction, for example.

Stiffening members <NUM> may be located (e.g., arranged) throughout frame <NUM> in a variety of configurations to provide additional stiffness and/or structural integrity to a particular frame shape. In other words, a wide variety of different shapes and/or arrangements of stiffening members <NUM> may be included within frame <NUM> in other to impart customized performance characteristics of frame <NUM>. For example, in some instances, it may be desirable to transfer rotational forces placed on head portion <NUM> to attachment arms <NUM> positioned at the distal portion of frame <NUM>. The addition of stiffening members <NUM> may allow transfer of those rotational forces throughout frame <NUM> (e.g., to the distal portion of frame <NUM>) while minimizing the amount of force lost and/or dissipated throughout the frame due to undesirable flexing of the frame members.

<FIG> shows another example of the frame <NUM>. For purposes of simplicity, the reference numerals depicted in <FIG> may represent analogous elements described in <FIG>. As shown in <FIG>, frame <NUM> may include a geometric shape that is similar to that described with respect to frame <NUM> shown in <FIG>. However, as illustrated in <FIG>, frame <NUM> may include stiffening members <NUM> extending and spaced in a different arrangement (as compared with the stiffening members <NUM> shown in <FIG>). Additionally, the frame <NUM> shown in <FIG> may include different apertures <NUM> created by the alternative arrangement of stiffening members <NUM>.

<FIG> and <FIG> further illustrate that frame <NUM> may include one or more attachment apertures <NUM> located along a distal portion <NUM> of one or more attachment arms <NUM>. For example, <FIG>/<FIG> show attachment apertures <NUM> positioned at a distal portion <NUM> of the attachment arms <NUM>. As will be discussed in greater detail below, attachment apertures <NUM> may be utilized to attach the frame <NUM> to an example implant <NUM>.

While <FIG> shows three attachment apertures <NUM> positioned along a distal portion <NUM> of each of the attachment arms <NUM>, the illustrated number of attachment apertures <NUM> is not intended to be limiting. In other embodiments, attachment apertures <NUM> may be located along another region of attachment arms <NUM>, such as a proximal portion of attachment arms <NUM> proximate body portion <NUM>. In other words, it is contemplated that one or more attachment arm apertures may be positioned along any portion of frame <NUM>. For example, <FIG> shows two attachment apertures <NUM> positioned along a distal portion <NUM> of each of the attachment arms <NUM>. The number of attachment apertures positioned along frame <NUM> may be <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more. In other instances, attachment arms <NUM> may be devoid of attachment apertures. In such instances, attachment arms <NUM> may include an alternative attachment structure for attaching to implant <NUM>.

For simplicity purposes, when combined with an example implant <NUM>, frame <NUM> may be defined as having a first surface that faces away from the implant <NUM> when implant <NUM> is attached to frame <NUM> (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant <NUM> (e.g., a second surface that faces a target site in the body). In some instances, attachment apertures <NUM> may extend from the first surface to the second surface. In other words, in some instances, attachment apertures <NUM> may be defined as holes and/or openings that extend through the thickness of frame <NUM> from the first surface of the frame <NUM> that faces away from the implant <NUM> to the second surface of the frame <NUM> that faces toward the implant <NUM>.

As stated above, attachment apertures <NUM> may be utilized to attach and/or couple frame <NUM> to an example implant <NUM>. <FIG> shows an example frame <NUM> attached to an example implant <NUM>. Further, <FIG> shows example frame <NUM> attached to example implant <NUM> at the distal or free end of each of the four attachment arms <NUM>, respectively. Attachment of free distal ends of attachment arms <NUM> to implant <NUM> may be made by any desired attachment mechanism.

<FIG> shows a detailed view of a portion of the proximal portion <NUM> of a frame <NUM> attached to an implant <NUM> in a configuration similar to that discussed above with respect to <FIG>. Further, <FIG> shows example attachment arm <NUM> including a distal portion <NUM>. Three attachment apertures <NUM> are positioned along the distal portion <NUM> of the attachment arm <NUM>. Additionally, <FIG> shows an example attachment member (e.g. wire) <NUM> extending between and through one or more of the attachment apertures <NUM> located on the distal portion <NUM> of attachment arms <NUM>.

Attachment members <NUM> may be one of several structures and/or techniques contemplated to attach example frame <NUM> to example implant <NUM>. As shown in <FIG>, attachment member <NUM> may be positioned, looped, wound and/or threaded through one or more attachment apertures <NUM> such that the member <NUM> is prevented from being pulled away from the distal portion <NUM> of attachment arm <NUM>. In other words, winding attachment member <NUM> through one or more attachment apertures <NUM> may effectively affix attachment member <NUM> onto the attachment arm <NUM>. In other words, it is contemplated that attachment member <NUM> may be affixed to the distal portion <NUM> of attachment arms <NUM> (via attachment apertures <NUM>, for example) without having either end of the attachment member <NUM> directly attached (e.g., welded, tied, etc.) to any structure (e.g., frame <NUM>). In some instances, member <NUM> may be wrapped and/or looped through attachment apertures <NUM> one or more times to provide a friction fit and/or resistive tension to unraveling or unwinding as a withdrawal force is applied to attachment member <NUM>.

While <FIG> shows a single attachment member <NUM> extending between two attachment apertures <NUM>, it is contemplated that attachment member <NUM> may extend and/or wrap between two or more attachment apertures <NUM>. For example, it is contemplated that attachment member <NUM> may be woven (e.g., over-and-under) through three apertures <NUM> in order to lock member <NUM> to the distal end <NUM> of attachment arm <NUM>.

The above discussion and the forgoing examples are not intended to limit the disclosure to using an attachment member (e.g., wire, thread, cable, etc.) to attach frame <NUM> to implant <NUM>. Rather, a variety of methodologies may be utilized to attach frame <NUM> to implant <NUM>. For example, adhesives may be used alone or in combination with another attachment mechanism to attach frame <NUM> to implant <NUM>. Additionally, a variety of injection molding techniques may be employed to attach frame <NUM> to implant <NUM>. Further, combinations of the disclosed techniques may be used to attach frame <NUM> to implant <NUM>. For example, an attachment member <NUM> may be used in conjunction with an adhesive to attach frame <NUM> to implant <NUM> without having to wind attachment member <NUM> through attachment apertures <NUM>.

As stated above, it is contemplated in the examples discussed herein that frame <NUM> may be able to be "detached" from implant <NUM>. For example, frame <NUM> may be configured to detach from implant <NUM> after implant <NUM> has been affixed to a target site in the body, such as with staples and/or sutures. Therefore, it can be appreciated that in some examples disclosed herein, frame member <NUM> may be temporarily attached to implant <NUM>. For example, frame member <NUM> may be coupled, affixed or attached to implant <NUM> while positioned within delivery sheath <NUM>, deployed out of delivery sheath <NUM> and maneuvered into position relative to a target site. Once positioned at the target site (e.g., along the tendon and/or humeral head), implant <NUM> may be rigidly affixed to the target site, such as stapled and/or sutured to bone and/or tendon tissue at the target site. However, once implant <NUM> has been rigidly affixed to the target site, frame <NUM> may be pulled away (e.g., detached) from implant <NUM> and removed from the body.

<FIG> shows an example attachment configuration which may allow frame <NUM> to detach from implant <NUM>. <FIG> shows attachment member <NUM> wound in a spiral pattern <NUM> along the surface of implant <NUM> facing a target site. In other words, attachment member <NUM> may form a spiral pattern <NUM> that remains in a plane substantially parallel to the plane of the surface of implant <NUM> which faces a target site. Further, it can be appreciated that attachment member <NUM> may extend from the side of attachment arm <NUM> facing away from implant <NUM>, through the combined thickness of the attachment arm <NUM> and implant <NUM>, eventually exiting implant <NUM> on the surface of implant <NUM> facing a target site. Further, it can be appreciated that the spiral pattern <NUM> shown in <FIG> is one of a variety of configurations for which attachment member <NUM> may be wound in order to prevent frame <NUM> from prematurely releasing from implant <NUM>.

Attachment member <NUM> may have a first end secured to a free distal end of attachment arm <NUM> positioned on a first side of implant <NUM> and have a second end positioned on a second, opposite side of implant <NUM>. In some instances, attachment member <NUM> may extend through implant <NUM> from the first side of implant <NUM> to the second side of implant <NUM>. However, in other instances, attachment member <NUM> may extend around an edge of implant <NUM> from the first side of implant <NUM> to the second side of implant <NUM>.

The attachment member <NUM> may be configured to be detached from implant <NUM> upon application of a threshold level of force. For example, the spiral pattern <NUM> shown in <FIG> may provide frame <NUM> the ability to detach from implant <NUM> when a threshold "pull-away force" is applied to frame <NUM>. For example, after implant <NUM> is affixed to a target site, a clinician may apply a force to frame <NUM> (via a tether, for example) such that frame <NUM> is pulled away from implant <NUM>. Provided the force is great enough (e.g., the threshold force is met), attachment members <NUM> (e.g., spiral portion <NUM> of attachment member <NUM> shown in <FIG>) may be unwound and pulled back through the "body" (e.g., thickness) of implant <NUM>, thereby releasing frame <NUM> from implant <NUM>. In other words, provided a threshold pull-away force is applied to frame <NUM>, the attachment member <NUM> forming the spiral <NUM> shown in <FIG> may unwind and pull back through implant <NUM>.

<FIG> shows another example method to attach frame <NUM> to an example implant <NUM>. As shown in <FIG>, attachment member <NUM> may include a spiral <NUM> positioned on the surface of the implant <NUM> which faces away from a target site (similar to spiral <NUM> shown in <FIG>). Additionally, <FIG> shows that attachment member <NUM> may include a second spiral <NUM> positioned on the surface of attachment arm <NUM> that faces away from implant <NUM>. In other words, <FIG> shows two spirals <NUM>/<NUM> formed at opposite ends of attachment member <NUM> and positioned on both the attachment arm <NUM> facing away from implant <NUM> (e.g., spiral <NUM> of <FIG>) and on the side of the implant <NUM> lying along a treatment site (e.g., spiral <NUM> of <FIG>). The configuration of spirals <NUM>/<NUM> may provide a frame <NUM> with a "releasable" connection to implant <NUM> similar to that discussed with respect to <FIG>.

<FIG> shows an example frame <NUM> coupled to an example implant <NUM> via attachment members <NUM> as described above. Further, <FIG> shows frame <NUM> in combination with implant <NUM> coupled to an example implant delivery system <NUM>. Similar to that discussed with respect to <FIG>, implant delivery system <NUM> includes implant delivery shaft <NUM> extending through an example lumen <NUM> of an example delivery sheath <NUM>.

Further, <FIG> shows the delivery shaft <NUM> coupled to frame <NUM> via a connection assembly <NUM>. Connection assembly <NUM> includes a first connection member <NUM> attached to the head portion <NUM> of frame <NUM> and a second connection member <NUM> attached to the distal end <NUM> of delivery shaft <NUM>. While <FIG> does not directly show first connection member <NUM> attached directly to second connection member <NUM>, it can be appreciated that the first and second connection members <NUM>/<NUM> of connection assembly <NUM> form a mating connection. For example, in some instances, first connection member <NUM> may form a male connection member while second connection member <NUM> may form a mating female connection member. In other words, in some examples second connection member <NUM> may include a cavity which is configured to extend over and allows first connection member <NUM> to be inserted therein. In other instances, the first connection member <NUM> may be a female connection member, while second connection member <NUM> may be a mating male connection member.

Additionally, as shown in <FIG>, according to the invention, the second connection member <NUM> disengages or decouples from first connection member <NUM>. For example, in some instances connection assembly <NUM> (including first and second connection members <NUM>/<NUM>) may be defined as a "quick release" connection assembly, or otherwise decoupling connection assembly.

The delivery shaft <NUM> is attached (via connection assembly <NUM>, for example) to the head portion <NUM> of frame member <NUM>. As shown in <FIG>, the first connection member <NUM> of connection assembly <NUM> is attached to head portion <NUM> via an aperture <NUM> (shown in <FIG>). In some instances, first connection member <NUM> may be attached to the head portion <NUM> of frame member <NUM> via a variety of mechanical fastening means (e.g., injection molding, encapsulation, bonding, etc.).

As discussed above, in some instances, a physician may insert implant delivery system <NUM> (including a delivery sheath <NUM>, delivery shaft <NUM>, frame <NUM> and implant <NUM>) through an incision and position the distal end of the implant delivery system <NUM> adjacent a target implant site (e.g., torn tendon). Once adjacent the target site, the physician may manipulate the implant delivery shaft <NUM> to advance the implant (while attached to the detachable frame <NUM>) out of the delivery sheath <NUM> adjacent the target implant site. For example, the physician may retract delivery sheath <NUM> proximally relative to delivery shaft <NUM> and frame <NUM> and/or may advance delivery shaft <NUM> and frame <NUM> distally relative to delivery sheath <NUM>.

<FIG> shows frame <NUM> and implant <NUM> deployed from the distal portion <NUM> of delivery sheath <NUM>. In some instances, frame <NUM> and implant <NUM> may have a substantially concave shape with respect to delivery sheath <NUM>. It can be appreciated that the concave shape of frame member <NUM> and implant <NUM> may facilitate positioning the implant <NUM> along the generally rounded shape of the human shoulder.

However, when positioned in the delivery sheath <NUM> (e.g., prior to deployment) the frame <NUM> and implant <NUM> may be wrapped around the delivery shaft <NUM> in a convex configuration. Therefore, frame <NUM> and implant <NUM> may shift from a first convex configuration (while wrapped tightly around delivery shaft <NUM> within lumen <NUM> of delivery sheath <NUM>) to a second concave configuration when advanced (e.g., deployed) out of sheath <NUM>.

In other words, frame <NUM> and implant <NUM> may be attached to the deliver shaft <NUM> via the connection assembly <NUM> when positioned within the lumen <NUM> of the delivery sheath <NUM>. In one example, when positioned within the delivery sheath <NUM>, the frame <NUM> and implant <NUM> may wrap, or extend around, the delivery shaft <NUM>. The position of the frame <NUM> and implant <NUM> may be in a convex configuration with respect to the distal end <NUM> of the delivery shaft <NUM>. As the frame <NUM> and implant <NUM> are deployed out of the distal end <NUM> of the delivery shaft <NUM>, the frame <NUM> and implant <NUM> may "shift" from a convex configuration to a concave configuration (as viewed with respect to the distal end <NUM> of delivery shaft <NUM>).

<FIG> illustrates another example detachable frame member <NUM> attached to an implant <NUM>. It is contemplated that any of the frame members and/or implants disclosed herein may be utilized in conjunction with any of the delivery systems and/or delivery system features disclosed herein. Further, frame member <NUM> and/or implant <NUM> may be similar in form and functionality to other example frame members described herein. For example, detachable frame member <NUM> and implant <NUM> may have a proximal portion <NUM> which, for purposes of discussion herein, may be adjacent delivery shaft <NUM> (described above) and be configured to be positioned adjacent humerus <NUM> (shown in <FIG>). Further, detachable frame member <NUM> and implant <NUM> may have a distal portion <NUM> which, for purposes of discussion herein, may extend away from deliver shaft <NUM> (described above) and be configured to be positioned adjacent tendon <NUM> (shown in <FIG>).

<FIG> shows example detachable frame member <NUM>. As illustrated in <FIG>, frame member <NUM> may include a central body portion <NUM>. In some examples, body portion <NUM> may be understood to define a circular, ovular, square, rectangular or similar shaped framework from which other members may extend. For example, body portion <NUM> of frame <NUM> may bear some resemblance to an elongated rectangle having a proximal portion <NUM> and a distal portion <NUM>. Body portion <NUM> may include one or more apertures <NUM>. Further, frame <NUM> may include a head portion <NUM> positioned within and/or extending away from the body portion <NUM>. Head portion <NUM> may include an aperture <NUM>.

<FIG> further illustrates that attachment arms <NUM> may include a variety of shapes. For example, in some instances, attachment arms <NUM> may include a bow and/or general curvilinear shape (such as that shown in the attachment arm <NUM> closest to head portion <NUM>). In other examples, an attachment arm <NUM> may include additional features, such as the circular portion <NUM> positioned adjacent one or more attachment arms <NUM> (as shown adjacent two attachment arms <NUM> located farthest from head portion <NUM>).

In some examples, frame <NUM> may include a variety of shapes and/or geometric arrangements. For example, while the above discussion has focused on the shape of frame <NUM> shown in <FIG>, it is not intended to be limiting. For example, frame <NUM> may include one or more stiffening members <NUM> extending throughout frame <NUM>, such as throughout body portion <NUM>. Further, stiffening member <NUM> may be arranged within frame <NUM> (e.g., within body portion <NUM>) such that it creates the one or more apertures <NUM>. The number, shape, configuration and/or arrangement of stiffening members <NUM> and/or apertures <NUM> may depend on the particular performance characteristics desired to be imparted to detachable frame <NUM>. For example, additional stiffening members <NUM> may be added to frame <NUM> to provide increased stiffness to frame <NUM>. In other instances, stiffening members <NUM> may take on particular geometries that increase stiffness or flexibility in a particular direction and/or region while decreasing stiffness or flexibility in a different direction and/or region, for example.

Stiffening members <NUM> may be located (e.g., arranged) throughout frame <NUM> in a variety of configurations to provide additional stiffness and/or structural integrity to a particular frame shape. In other words, a wide variety of different shapes and/or arrangements of stiffening members <NUM> may be included within frame <NUM> to impart customized performance characteristics on frame <NUM>. For example, in some instances it may be desirable to transfer rotational forces placed on head portion <NUM> to attachment arms <NUM> positioned at the distal portion <NUM> of frame <NUM>. The addition of stiffening members <NUM> may transfer those rotational forces throughout frame <NUM> (e.g., to the distal portion <NUM> of frame <NUM>) while minimizing the amount of force lost and/or dissipated throughout the frame <NUM> due to undesirable flexing of the frame members.

<FIG> further illustrates that frame <NUM> may include an extension member <NUM> extending away from head portion <NUM> (when viewed in the planar configuration shown in <FIG>). Extension member <NUM> may include a connection aperture <NUM> formed in a proximal region <NUM> of extension member <NUM><NUM>. Additionally, extension member <NUM> may include one or more extension arms <NUM> extending to a proximal portion of body portion <NUM>. Extension arms <NUM> may be part of (e.g., a monolithic structure with) body portion <NUM>. <FIG> illustrates that extension arms <NUM> may include a curve. However, it is contemplated that the shape of extension portion <NUM> (including extension arms <NUM> and/or aperture <NUM>) may include a variety of shapes and/or configurations.

<FIG> further illustrates that frame <NUM> may include one or more attachment channels <NUM> located along a distal portion <NUM> of one or more attachment arms <NUM>. For example, <FIG> shows attachment channels <NUM> positioned at a distal portion <NUM> of the attachment arms <NUM>. As will be discussed in greater detail below, attachment channels <NUM> may be utilized to attach the frame <NUM> to an example implant. While <FIG> shows a single attachment channel <NUM> positioned along a distal portion <NUM> of each of the attachment arms <NUM>, the illustrated number of attachment channels <NUM> is not intended to be limiting. In other words, it is contemplated that one or more attachment channels <NUM> may be positioned along any portion of frame <NUM>. The number of attachment channels <NUM> positioned along frame <NUM> may be <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more. In other instances, attachment arms <NUM> may be devoid of attachment channels <NUM>. In such instances, attachment arms <NUM> may include an alternative attachment structure for attaching to an implant.

When combined with an example implant, frame <NUM> may be defined as having a first surface that faces away from the implant when the implant is attached to frame <NUM> (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant (e.g., a second surface that faces a target site in the body). In some instances, attachment channels <NUM> may extend from the first surface to the second surface. In other words, in some instances, attachment channels <NUM> may be defined as openings that extend through the thickness of frame <NUM> from the first surface of the frame <NUM> that faces away from the implant to the second surface of the frame <NUM> that faces toward the implant.

As stated above, attachment channels <NUM> may be utilized to attach and/or couple frame <NUM> to an example implant. <FIG> shows an example frame <NUM> attached to an example implant <NUM>. Further, <FIG> shows example frame <NUM> attached to example implant <NUM> at the distal or free end of each of the four attachment arms <NUM>, respectively. Attachment of free distal ends of attachment arms <NUM> to implant <NUM> may be made by any desired attachment mechanism.

As will be described in greater detail below, <FIG> further illustrates locking covers <NUM> positioned along the distal portion <NUM> of attachment arms <NUM>. Locking cover <NUM> may be used in conjunction with attachment channels <NUM> to secure frame <NUM> to implant <NUM>. Locking covers <NUM> may be constructed of a variety of materials. For example, locking covers <NUM> may include a metal, a polymer or combinations thereof, for example.

<FIG> shows a detailed view of a portion of frame <NUM> attached to an implant <NUM> in a configuration similar to that discussed above with respect to <FIG> and <FIG>. Specifically, <FIG> shows example attachment arm <NUM> including a distal portion <NUM>. Attachment channels <NUM> are positioned along the distal portion <NUM> of the attachment arm <NUM>. Additionally, <FIG> shows an example attachment member (e.g. wire) <NUM> extending between and/or through one or more of the attachment channels <NUM> located on the distal portion <NUM> of attachment arms <NUM>.

Attachment member <NUM> may include a variety of structures and/or techniques designed to attach example frame <NUM> to example implant <NUM>. As shown in <FIG>, attachment member <NUM> may be inserted, looped, wound and/or threaded through one or more attachment channels <NUM> such that the attachment member <NUM> is prevented from being pulled away from the distal portion <NUM> of attachment arm <NUM>. In other words, sliding, inserting and/or winding attachment member <NUM> through one or more attachment channels <NUM> may effectively affix attachment member <NUM> to attachment arm <NUM>. In other words, it is contemplated that attachment member <NUM> may be affixed to the distal portion <NUM> of attachment arms <NUM> (via attachment channels <NUM>, for example) without having either end of the attachment member <NUM> permanently attached (e.g., welded, etc.) to any structure (e.g., frame <NUM>). In some instances, attachment member <NUM> may be wrapped and/or looped through attachment channel <NUM> one or more times to provide a friction fit, interference fit, and/or resistive tension to unraveling or unwinding as a withdrawal force is applied to attachment member <NUM>.

<FIG> further illustrates that attachment channel <NUM> may include an opening that extends through the thickness of attachment arm <NUM> (e.g., from a top surface to the bottom surface of attachment arm <NUM>) and also that attachment channel <NUM> may extend through the sidewall <NUM> of attachment arm <NUM> such that attachment member <NUM> may be laterally inserted into and/or removed from attachment channel <NUM>. Additionally, attachment channel <NUM> may include one or more widths along the length of attachment channel <NUM>. For example, <FIG> shows attachment channel <NUM> including a first width "X" which extends through sidewall <NUM> of attachment arm <NUM>. Attachment channel <NUM> further includes a second width "Y. " In some instances, width "X" may be narrower than width "Y. " Further, it can be appreciated that width "X" may be sized such that it is slightly smaller than the width (e.g., diameter) of attachment member <NUM>. Additionally, the general shape of attachment channel <NUM> may be designed such that it may flex to an extent sufficient to permit attachment member to extend (e.g., be inserted) through the narrower portion of channel <NUM> defined by the width "X" and further advanced into the wider portion of channel <NUM> defined by width "Y.

<FIG> further illustrates example detents <NUM>. Detents may extend inwardly from the surface of sidewall <NUM>. In some instances, detents <NUM> may be designed to mate with a protrusion or tab extending from an inner surface of locking member <NUM>. Alternatively, detents may be protrusions or protuberances extending from the surface of attachment arm <NUM> configured to engage and/or mate with a feature of locking cover <NUM>.

Similar to that described above with respect to <FIG>, <FIG> shows an example attachment configuration which may allow frame <NUM> to detach from implant <NUM>. For example, <FIG> shows a portion of attachment member <NUM> wound in a spiral pattern <NUM> along the surface of implant <NUM> facing a target site. In other words, attachment member <NUM> may form a spiral pattern <NUM> that remains in a plane substantially parallel to the plane of the surface of implant <NUM> which faces a target site. Further, it can be appreciated that attachment member <NUM> may extend from the side of attachment arm <NUM> facing away from implant <NUM>, through the combined thickness of the attachment arm <NUM> (e.g., via attachment channel <NUM>) and implant <NUM>, eventually exiting implant <NUM> on the surface of implant <NUM> facing a target site. The attachment member <NUM> may include a retention portion, such as a spiral pattern <NUM> positioned on the opposite side of implant <NUM> from attachment arm <NUM> for coupling implant <NUM> to attachment arm <NUM>. Further, it can be appreciated that the spiral pattern <NUM> shown in <FIG> is one of a variety of configurations for which attachment member <NUM> may be wound in order to prevent frame <NUM> from prematurely releasing from implant <NUM>. Further, as described above, when a sufficient threshold pull-away force is applied to frame <NUM>, the portion of attachment member <NUM> forming the spiral <NUM> shown in <FIG> may unwind and/or straighten and pull back through implant <NUM>. Instead of spiral <NUM>, it is contemplated that attachment member <NUM> may have another shaped configuration positioned on the surface of implant <NUM> facing a target site, which may be straightened upon a sufficient removal force to pull back through implant <NUM>.

<FIG> further shows locking member <NUM> positioned along the distal portion <NUM> of attachment arm <NUM>. In at least some examples disclosed herein, locking member <NUM> may be able to translate (e.g., slide) along attachment arm <NUM>. For example, <FIG> shows the distal portion <NUM> of attachment arm <NUM> extending through at least a portion of locking member <NUM>. In such instances, locking member <NUM> may be a sleeve in which attachment arm <NUM> extends through lumen of sleeve. In at least some examples disclosed herein, locking member <NUM> is designed such that there is sufficient clearance between the inner surface (e.g., the inner diameter) of locking member <NUM> and the outer surface (e.g., the outer diameter) of attachment arm <NUM> such that locking member <NUM> can slide along attachment arm <NUM>.

It can further be appreciated that locking member <NUM> may slide along attachment arm <NUM> to a position in which locking member <NUM> covers attachment member <NUM> and/or attachment channel <NUM>. For example, <FIG> shows locking member <NUM> positioned at the distal end <NUM> of the attachment arm <NUM>. Further, <FIG> shows locking member <NUM> positioned over the top (e.g., covering) of attachment member <NUM> and attachment channel <NUM>. It can be appreciated that when positioned over the top of the attachment member <NUM> and/or attachment channel <NUM>, locking member <NUM> may pinch, hold, secure, and/or lock attachment member <NUM> to attachment arm <NUM>, such as by securing or locking attachment member <NUM> in attachment channel <NUM>. In some examples, locking member <NUM> may resemble a "compression-like" fitting wherein locking member <NUM> is drawn over the top of attachment member <NUM>, thereby compressing attachment member <NUM> onto attachment arm <NUM> such that attachment member <NUM> is prevented from separating from attachment arm <NUM>.

Additionally, when locking member <NUM> is positioned over the top of attachment member <NUM> and/or attachment channel <NUM>, locking member <NUM> may lock in place via detents <NUM>. In other words, when locking member <NUM> is positioned in its securement position, in which the attachment member <NUM> is secured to attachment arm <NUM>, a feature of locking member <NUM> engages detents <NUM> to inhibit or prevent locking member <NUM> from moving back to the unsecured position shown in <FIG>. For example, it can be appreciated that the locking member <NUM> may include one or more inwardly projecting tabs (not shown) designed to be inserted (e.g., mate with) detents <NUM>. The combination of tabs and detents <NUM> are, therefore, designed to prevent locking member <NUM> from moving along attachment arm <NUM> after having been positioned over top the attachment member <NUM> and/or attachment channel <NUM>.

During assembly of implant <NUM> to frame <NUM>, attachment member <NUM> may be passed through implant <NUM> with distal enlarged portion (e.g., spiral <NUM>) positioned on a second surface of implant <NUM> facing away from frame <NUM>. Portion of attachment member <NUM> extending from a first surface of implant <NUM> facing frame <NUM> may then be passed through attachment channel <NUM>, such as passed laterally into attachment channel <NUM> and then bent, wound or otherwise manipulated around attachment arm <NUM>. Locking member <NUM> may then be moved from a first, unsecured position, shown in <FIG> to a second, secured position, shown in <FIG> to secure attachment member <NUM> to attachment arm <NUM>.

<FIG> illustrates a perspective view of frame <NUM> representing the configuration frame <NUM> would be in when inserted into the body. For example, <FIG> shows frame <NUM> including extension member <NUM> coupled to both connection member <NUM> (similar in form and function to connection member <NUM> discussed above) and head portion <NUM>. As illustrated in <FIG>, extension member <NUM> may curve upward and back on itself (e.g., upward and back toward the distal end <NUM> of frame <NUM>). Further, head portion <NUM> may extend upward and away from the body portion <NUM> of frame <NUM>. It can be appreciated that connection member <NUM> may couple extension member <NUM> to head portion <NUM> via the apertures <NUM> and <NUM>. In other words, connection member <NUM> may be inserted through both apertures <NUM> and <NUM>, thereby securing extension member <NUM> to head portion <NUM>. Additionally, <FIG> shows a tack member <NUM> extending through a portion of frame <NUM>. Tack member <NUM> will be described in greater detail below.

Additionally, <FIG> illustrates that frame <NUM> may form a concave configuration when being inserted into the body. It can be appreciated that the concave shape of frame <NUM> may follow the contour of anatomy (e.g., shoulder) in which the example implant is to be secured.

<FIG> illustrates a side view of frame <NUM> described in <FIG>. <FIG> illustrates the concave shape of frame <NUM>. Additionally, <FIG> shows extension member <NUM> curving upward and back toward distal portion <NUM> of frame <NUM> as described above. Further, <FIG> shows head portion <NUM> extending upward and away from body portion <NUM> of frame <NUM>. Extension member <NUM> and the head portion <NUM> are coupled to one another via connection member <NUM> extending through connection apertures <NUM>, <NUM>. Thus, connection apertures <NUM>, <NUM> may be coaxial, with connection member <NUM> extending therethrough. Additionally, <FIG> shows tack member <NUM> (similar in form and function to connection member <NUM> discussed above) extending through a portion of frame <NUM>, such that the distal tip of tack member <NUM> would penetrate through implant <NUM> to be positioned a distance below the lower surface (the surface of implant <NUM> opposite the frame <NUM>) of implant <NUM>.

In some instances, the configuration of frame <NUM> shown in <FIG> may provide both precise control and maneuverability to a clinician or other operator of the medical device. For example, the geometry of the extension member <NUM> in combination with head portion <NUM> and connection member <NUM> may provide precise maneuverability of the distal portion <NUM> of frame <NUM>. For example, in some instances, an operator may manipulate connection member <NUM> with a delivery shaft <NUM> (described above). The delivery shaft may be able to impart a downward force (e.g., a force directed toward a patient's shoulder) onto frame <NUM> via the combination of connection member <NUM>, extension member <NUM> and head portion <NUM>. Further, the concave geometry of frame <NUM> may allow the distal portion of frame <NUM> to extend along the surface of the shoulder for which the implant <NUM> is to be positioned. In other words, the geometry of frame <NUM> shown in <FIG> and <FIG> may prevent the distal portion <NUM> of frame <NUM> (including attachment arms <NUM>) from pulling up and away from the shoulder surface as a clinician manipulates frame <NUM> within the body. Further, the geometry of frame <NUM> shown in <FIG> and <FIG> may allow the distal portion <NUM> of frame <NUM> to be advanced toward the surface of the shoulder in which an implant <NUM> is to be positioned.

Additionally, the geometry of frame <NUM> shown in <FIG> may allow a clinician improved visibility of the frame <NUM> (e.g., the distal portion <NUM> of frame <NUM>) during implantation of the medical device. For example, in some instances a clinician may position a camera adjacent the implantation site. The clinician may utilize the camera to accurately maneuver and/or position an example implant into the patient. However, in some instances, the camera my obscure and/or impede the visibility of all or a portion of the frame or implant (e.g., frame <NUM> and/or implant <NUM>). However, the geometry of frame <NUM> shown in <FIG> may allow the connection member <NUM> (and delivery sheath <NUM> coupled to connection member <NUM>) to be inserted at an angle (depicted as "θ" in <FIG>) which is directed away from the distal end <NUM> of frame <NUM>. It can be appreciated that angle θ may be measured from a line <NUM> that is orthogonal to a line <NUM> tangent to a point <NUM> generally positioned at the apex of a curve defined by body portion <NUM>. Orienting connection member <NUM> such that it is directed away from the distal end <NUM> of frame <NUM> may increase the amount of space for which a camera may be placed during a procedure. In other words, a clinician may be able to maneuver the camera such that it provides improved visibility of all or a portion of the medical device being implanted (e.g., implant <NUM> via frame <NUM>).

As briefly described above with respect to <FIG> and <FIG>, any of the implant delivery systems described herein may include a tack member designed to "anchor" the delivery system in place prior to a clinician affixing implant <NUM> to the bone and/or tendon. For example, <FIG> illustrates a tack member <NUM> extending distally from the first connection member <NUM>. As shown in <FIG>, tack member <NUM> may extend distally from first connection member <NUM> and be substantially perpendicular to implant <NUM> and/or frame <NUM>. In some instances, tack member <NUM> may extend generally parallel to the longitudinal axis of delivery sheath <NUM> and/or delivery shaft <NUM> with the frame <NUM> and implant <NUM> extending generally perpendicular to the longitudinal axis of delivery sheath <NUM> and/or delivery shaft <NUM>. However, this configuration is not intended to be limiting. Rather, it is contemplated that tack member <NUM> may extend distally from the first connection member <NUM> and/or frame <NUM> at an oblique angle to the longitudinal axis of delivery sheath <NUM>, delivery shaft <NUM>, and/or frame <NUM>.

In some instances, tack member <NUM> may resemble a cylindrical pin or rod extending away from frame <NUM>. 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., delivery shaft <NUM>) such that tack member <NUM> may be "hammered" into a body structure (e.g., bone). In some instances, tack member <NUM> may include a tapered distal tip, which may be a sharpened or blunt tapered distal tip in some instances.

In some instances, tack member <NUM> may be stationary (e.g., fixed in place) relative to frame <NUM> and/or first connection member <NUM> of connection assembly <NUM>. For example, tack member <NUM> may extend distally from first connection member <NUM> and away from the surface of frame <NUM> which faces a target site.

Further, in one example tack member <NUM> may be the first portion of delivery system <NUM> that exists the distal end <NUM> of delivery sheath <NUM> when the frame <NUM> and delivery shaft <NUM> are advanced out of the delivery sheath <NUM> upon deployment of the delivery system <NUM>. In some instances, as the delivery sheath <NUM> is advanced through an insertion site toward a target site, the frame <NUM> (to which implant <NUM> is attached) and a stationary tack member <NUM> may be fully housed within the lumen <NUM> of delivery sheath <NUM>. Additionally, as the delivery shaft <NUM> is advanced out the distal end <NUM> of the delivery sheath <NUM>, the stationary tack member <NUM> may be driven directly into an adjacent structure (e.g., bone).

However, in other examples, frame member <NUM> and implant <NUM> may be positioned within delivery sheath <NUM> (depicted as dashed line) as shown in <FIG> shows frame member <NUM> (with implant <NUM>) substantially aligned longitudinally with delivery shaft <NUM> and tack member <NUM>. In this example, the distal portion <NUM> of frame <NUM> and implant <NUM> may be located distal of tack member <NUM> within delivery sheath <NUM>, and thus the first portion of delivery system <NUM> that exits the distal end <NUM> of delivery sheath <NUM> when the frame <NUM> and delivery shaft <NUM> are advanced out of the delivery sheath <NUM> upon deployment of the delivery system <NUM>.

In yet other examples, a frame member <NUM> and implant <NUM> may be positioned within delivery sheath <NUM> (depicted in dashed lines) as shown in <FIG>. Delivery sheath <NUM> may be similar in form and function to delivery sheath <NUM> discussed above. Further, <FIG> shows frame member <NUM> (and implant <NUM>) substantially aligned longitudinally with delivery shaft <NUM> (similar in form and function to delivery shaft <NUM> discussed above) and tack member <NUM>. In this example, the distal portion of frame <NUM> and implant <NUM> may be located distal of tack member <NUM> within delivery sheath <NUM>, and thus the first portion of delivery system <NUM> that exits the distal end of delivery sheath <NUM> when the frame <NUM> and delivery shaft <NUM> are advanced out of the delivery sheath <NUM> upon deployment of the delivery system <NUM>.

Additionally, <FIG> illustrates that implant <NUM> may be rolled up and positioned between frame member <NUM> and the delivery sheath <NUM>. Further, it can be appreciated that when positioned in delivery sheath <NUM> as illustrated in <FIG>, implant <NUM> may wrap around frame member <NUM> with frame member <NUM> located radially inward of implant <NUM>, and thereby extend along all or a portion of the inner surface of delivery sheath <NUM>. Upon exiting the distal end of delivery sheath <NUM>, implant <NUM> may unwrap to a configuration illustrated in <FIG> and <FIG>.

In other examples, tack member <NUM> may translate (e.g., slide, move, etc.) along a longitudinal axis within a lumen (not shown) of first connection member <NUM> of connection assembly <NUM>. For example, <FIG> shows example deployment system <NUM> positioned adjacent an example target site. <FIG> shows the proximal portion <NUM> of the frame <NUM> (along with implant <NUM>) positioned adjacent the humeral head <NUM>. In this position, the distal portion <NUM> of the frame <NUM> is positioned adjacent the tendon <NUM>. <FIG> further illustrates that the tack member <NUM> has not been advanced and/or extended out of the first connection member <NUM> of connection assembly <NUM> and driven into the humeral head. Rather, the tack member <NUM> remains positioned within the connection assembly <NUM> (e.g., positioned within first connection member <NUM>). However, in some examples contemplated herein, tack member <NUM> may be advanced out of the distal portion of delivery shaft <NUM> and/or connection assembly <NUM>. In other words, the tack member <NUM> translates (e.g., slides, moves, etc.) relative to connection assembly <NUM> and advances away from the distal end <NUM> of delivery shaft <NUM>.

<FIG> illustrates tack member <NUM> being advanced out of the distal portion <NUM> of delivery shaft <NUM> after delivery shaft <NUM> (along with frame <NUM> and implant <NUM>) have been maneuvered and/or positioned adjacent an example target site. In some examples, <FIG> may depict delivery system <NUM> (discussed with respect to <FIG> and <FIG>) after the tack member <NUM> has been advanced out of the distal end <NUM> of the delivery shaft <NUM> (e.g., advanced distally of first connection member <NUM>) and into the humeral head <NUM>. As discussed above, tack member <NUM> may be advanced out of the distal end <NUM> of delivery shaft <NUM> via the application of a force at the proximal end of the delivery system <NUM> and/or actuation of an actuation mechanism to move tack member <NUM> relative to first connection member <NUM>. In some instances, a handle component may be utilized to generate a force to advance tack member <NUM> along a longitudinal axis of delivery shaft <NUM> and exit the distal end <NUM> of delivery shaft <NUM> distal of first connection member <NUM>.

In some instances, once tack member <NUM> has been anchored into a target site (e.g., humeral head <NUM>) it may be desirable to remove the delivery shaft <NUM> to make room for additional instruments to be advanced adjacent the target site. <FIG> illustrates removing delivery shaft <NUM> from the target site (depicted by the arrow in <FIG>) while the frame <NUM> and implant <NUM> remain anchored to the humeral head <NUM> via the tack member <NUM>. As discussed above, delivery shaft <NUM> may be detached from frame <NUM> via uncoupling (e.g., detaching) second connection member <NUM> from first connection member <NUM>.

In some instances, it may be desirable to reengage delivery shaft <NUM> after detaching second connection member <NUM> from first connection member <NUM>. For example, in some instances, the bone (e.g., humeral head) in which tack member <NUM> is initially inserted may be abnormally soft or hard, and therefore, may require additional force to either maintain placement (e.g., if the bone is too soft) or to remove (e.g., if the bone is too hard). Therefore, a clinician may choose to reinsert and reengage shaft member <NUM> to frame <NUM> via re-coupling second connection member <NUM> to first connection member <NUM>, such as after implant <NUM> has been attached to a target site via one or more bone and/or tendon staples, as described below. Alternatively, shaft member <NUM> may remain engaged to frame <NUM> while attaching implant <NUM> to a target site via one or more bone and/or tendon staples, as described below. The clinician may then be able to apply additional force to frame <NUM> and/or tack member <NUM> when attaching implant <NUM> to an example target site via one or more bone and/or tendon staples.

In some instances, delivery system <NUM> may include a tether <NUM> coupled to frame <NUM>. For example, <FIG> shows tether <NUM> attached to first connection member <NUM>. However, it is contemplated that in some examples tether <NUM> may be coupled directly to frame <NUM> and/or any other suitable structure. Further, tether <NUM> may be a rigid structure (e.g., rod) or it may be a non-rigid structure (e.g., a wire, cable, etc.). Additionally, it can be appreciated that tether <NUM> may be long enough to extend from frame <NUM> positioned at the target site to a location exterior of the patient through insertion site (i.e., incision), such as through a lumen <NUM> of delivery shaft <NUM> and out of a proximal portion of the implant delivery system <NUM> (e.g., proximal portion of delivery shaft <NUM>).

Further, it can be appreciated that tether <NUM> may remain attached to frame <NUM> (e.g., via first connection member <NUM>) and extend to a location exterior of the patient through insertion site (i.e., incision) with delivery shaft <NUM> detached from frame <NUM> and removed from insertion site (i.e., incision) while additional instruments are advanced through the insertion site and to the target site. For example, <FIG> shows a medical instrument <NUM> (e.g., implant stapler) positioned adjacent the proximal end <NUM> of the frame <NUM> and implant <NUM>. As discussed above and shown in <FIG>, tether <NUM> remains attached to frame <NUM> (e.g., via first connection member <NUM>) and is positioned exterior of and alongside example medical instrument <NUM>. The medical instrument <NUM> may be used to attach implant <NUM> to treatment site, such as with one or more, or a plurality of staples and/or sutures.

As discussed above, in some instances, implant <NUM> may be affixed to a target site after which the frame <NUM> may be detached (and removed) from both implant <NUM> and the target site. For example, in some instances, implant <NUM> may be attached to a target site via one or more bone and/or tendon staples. The staples may be applied to the target site via a stapling instrument (e.g., medical instrument <NUM>).

Further, in some instances, it may be beneficial to affix implant <NUM> to the bone portion of the target site (e.g., humeral head <NUM>) prior to affixing the implant to the tendon portion <NUM> of the target site. For example, it may be beneficial for a clinician to orient and/or position the frame <NUM> and implant <NUM> in the location/arrangement shown in <FIG> prior to affixing the implant to the target site. As shown in <FIG> (and previously discussed) the implant is positioned such that the proximal portion <NUM> of the frame <NUM> and implant <NUM> are positioned adjacent the humeral head <NUM>, while the distal portion <NUM> is positioned adjacent the tendon <NUM>. Once the frame <NUM> and implant <NUM> have been placed appropriately, it may be desirable to utilize a stapling instrument to first insert staples along the proximal portion <NUM> of the implant (e.g., the portion of the implant <NUM> positioned adjacent the bone) and into bone, followed by insertion of staples along the sides and distal portion of implant <NUM> and into tendon tissue.

It can be further appreciated that because the examples disclosed herein allow for the removal of the delivery sheath <NUM> and delivery shaft <NUM> prior to insertion of the stapling instrument, sufficient room exists to manipulate the stapling instrument in order to accurately place the staples along the proximal portion <NUM> of the implant adjacent the humeral head <NUM>.

Additionally, as discussed above, the tack member <NUM> may anchor the frame <NUM> and implant <NUM> in place (e.g., to the bone <NUM>), thereby allowing a clinician to remove the delivery shaft <NUM> without fear that the frame/implant <NUM>/<NUM> combination will change position prior to the insertion of staples into the implant <NUM>.

Claim 1:
An implant delivery system for delivering a tendon implant, the implant delivery system comprising:
a delivery shaft (<NUM>) including a proximal portion and a distal portion (<NUM>); characterised by
a detachable frame (<NUM>) coupled to the distal portion (<NUM>) of the delivery shaft (<NUM>), wherein the detachable frame (<NUM>) includes a body portion (<NUM>) and a plurality of attachment arms (<NUM>) extending away from the body portion (<NUM>); and
a connection assembly (<NUM>) including a first connection member (<NUM>) attached to the frame (<NUM>) and a second connection member (<NUM>) attached to the distal portion (<NUM>) of the delivery shaft (<NUM>), wherein the first connection member (<NUM>) and the second connection member (<NUM>) form a releasable mating connection;
wherein the plurality of attachment arms (<NUM>) are attached to an implant (<NUM>);
wherein the detachable frame (<NUM>) is configured to detach from the delivery shaft (<NUM>) in vivo while the detachable frame (<NUM>) remains attached to the implant.