Patent Publication Number: US-2023149151-A1

Title: Medical implant delivery system

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of International Application No. PCT/US2021/043668, filed Jul. 29, 2021, titled MEDICAL IMPLANT DELIVERY SYSTEM, which claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 63/060,466, filed on Aug. 3, 2020, titled MEDICAL IMPLANT DELIVERY SYSTEM, the disclosures of which are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure pertains generally, but not by way of limitation, to orthopedic implants and methods of treatment. More particularly, the present disclosure relates to a tendon repair implant, such as one that is engineered for arthroscopic placement over or in the area of a full or partial thickness tear of the supraspinatus tendon of the shoulder or other tendon, and an associated delivery device. 
     BACKGROUND 
     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 procedures for treatment of a torn tendon include affixing a biocompatible implant over the torn tendon. 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. 
     BRIEF SUMMARY 
     This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example implant delivery system includes a delivery shaft including a proximal portion and a distal portion, a frame coupled to the distal portion of the delivery shaft, the frame including a body portion and at least first and second arms, the first and second arms each having first ends attached to the body portion and second, free ends opposite the first ends, the first arm having a first tab disposed adjacent its free end, the second arm having a second tab disposed adjacent its free end, and the body portion having a third tab, wherein the first tab extends toward the free end of the first arm and the second tab extends toward the body portion, and wherein the first, second, and third tabs are all configured to be releasably attached to an implant. 
     Alternatively or additionally to any of the embodiments above, the first and second tabs include a sharp tip configured to extend at least partially through the implant. 
     Alternatively or additionally to any of the embodiments above, the body portion and first and second arms define a Y shape. 
     Alternatively or additionally to any of the embodiments above, the first and second arms each extend at an angle from the body portion such that when the third tab engages an edge of an implant, the free ends of the first and second arms are disposed adjacent opposing edges of the implant. 
     Alternatively or additionally to any of the embodiments above, the third tab extends toward the free ends of the first and second arms. 
     Alternatively or additionally to any of the embodiments above, the third tab is blunt and configured to engage an edge of the implant. 
     Alternatively or additionally to any of the embodiments above, the third tab includes a sharp tip configured to extend at least partially through the implant. 
     Alternatively or additionally to any of the embodiments above, the frame has a concave shape between the body portion and the free ends of the first and second arms. 
     Alternatively or additionally to any of the embodiments above, the frame has an upper surface and a lower surface, and the first and second tabs extend downward from the lower surface. 
     Alternatively or additionally to any of the embodiments above, the first and second arms are fixed to the body portion and have a fixed length. 
     Alternatively or additionally to any of the embodiments above, an entirety of the frame, including the body portion and first and second arms, is formed from a single, monolithic piece. 
     Alternatively or additionally to any of the embodiments above, the implant delivery system further comprises a tack member connected to the body portion. 
     Alternatively or additionally to any of the embodiments above, the frame is removably coupled to the delivery shaft, and configured to be detached from the delivery shaft in vivo. 
     Alternatively or additionally to any of the embodiments above, the implant delivery system further comprises a tether extending through a lumen of the delivery shaft, the tether fixedly attached to the frame such that the tether remains attached to the frame when the delivery shaft is detached from the frame. 
     Another implant delivery system includes a delivery shaft including a proximal portion and a distal portion, a frame coupled to the distal portion of the delivery shaft, the frame including a body portion and at least first and second arms extending from the body portion, the frame including a plurality of tabs configured to releasably engage an implant, the first and second arms each having free ends, the free end of the first arm defining a first tab, the free end of the second arm defining a second tab, and the body portion having a third tab, wherein the first, second, and third tabs are configured to engage at least one edge of the implant. 
     Alternatively or additionally to any of the embodiments above, the free ends of the first and second arms are bent such that when the first and second arms are disposed on an upper surface of a planar implant, the free ends of the first and second arms wrap around side edges of the implant forming first and second tabs that extend along a lower surface of the implant. 
     Alternatively or additionally to any of the embodiments above, the body portion and first and second arms define a Y shape. 
     Alternatively or additionally to any of the embodiments above, the first and second arms each extend at an angle from the body portion such that when the third tab engages the at least one edge of the implant, the free ends of the first and second arms are disposed adjacent the at least one edge at opposing edges of the implant. 
     Alternatively or additionally to any of the embodiments above, when the implant is a polygon and the third tab engages a first edge of the implant, the first and second tabs of the first and second arms are configured to engage second and third edges of the implant adjacent the first edge of the implant. 
     Alternatively or additionally to any of the embodiments above, when the implant is circular and has an outer edge, and the third tab engages a first location on the outer edge, the first and second tabs of the first and second arms are configured to engage second and third locations on the outer edge of the implant spaced apart from the first location. 
     An example implant assembly includes a one-piece planar implant, and a delivery system including an outer shaft including a proximal end, a distal end, and a lumen extending therebetween, an inner shaft slidably disposed within the lumen of the outer shaft, and a frame fixedly attached to a distal end of the inner shaft and configured to be releasably attached to the implant, the frame including a body portion and at least first and second arms extending from the body portion, each of the first and second arms having a free end configured to penetrate the implant when inserted through the implant in a first direction, and to resist withdrawal from the implant when pulled in a second direction opposite the first direction, wherein the first and second arms are woven into and out of the implant. 
     Alternatively or additionally to any of the embodiments above, the free ends of the first and second arms each include a sharp distal tip and a flared region proximal of the sharp distal tip. 
     Alternatively or additionally to any of the embodiments above, the frame, including the body portion and first and second arms, is formed from as a single, monolithic piece. 
     Alternatively or additionally to any of the embodiments above, the frame defines a single concave arc between the body portion and the free ends of the first and second arms. 
     Alternatively or additionally to any of the embodiments above, the first and second arms are fixed to the body portion and have a fixed length. 
     Alternatively or additionally to any of the embodiments above, the body portion and first and second arms define a Y shape. 
     The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which: 
         FIG.  1    illustrates a cross-section of an anterior view of a shoulder of a patient; 
         FIG.  2    illustrates a shoulder including a head of the humerus mating with the glenoid fossa of the scapula at a glenohumeral joint and an implant delivery system positioned over a tendon; 
         FIG.  3    illustrates an example implant delivery device attached to an implant; 
         FIG.  4 A  is a cross-sectional view taken along line A-A in  FIG.  3   ; 
         FIG.  4 B  is a cross-sectional view taken along line B-B in  FIG.  3   ; 
         FIG.  5 A  illustrates a side view of the example implant delivery device of  FIG.  3    with the sheath in cross-section; 
         FIG.  5 B  illustrates an end view along line  5 B- 5 B in  FIG.  5 A ; 
         FIGS.  6 - 10    illustrate an exemplary method of installing an implant with an example implant delivery device at a target site; 
         FIG.  11    illustrates another example implant delivery device attached to an implant; 
         FIG.  12    illustrates another example implant delivery device attached to an implant; 
         FIG.  13 A  is a cross-sectional view taken along line  13 - 13  in  FIG.  12    without the implant; 
         FIG.  13 B  is a cross-sectional view taken along line  13 - 13  in  FIG.  12   ; 
         FIG.  14    illustrates another example implant delivery device attached to an implant; and 
         FIG.  15    illustrates another example implant delivery device attached to an implant. 
     
    
    
     While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure. 
     DETAILED DESCRIPTION 
     For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. 
     The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
     As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
     It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary. 
     The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. 
     Rotator cuff surgeries are most frequently performed arthroscopically through various portals outside the shoulder. In order to successfully complete the repairs, the surgeons require appropriately sized medical devices that fit through the skin portals created. An accepted treatment for rotator cuff tears includes 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 or planar implant over the repaired tendon to mechanically reinforce the repaired tendon. In order to fix the implant to the native tendon, a delivery device including a sheath may be used to shield the implant from the soft tissue during insertion into the joint. Once inside the joint space, the implant may be deployed from the sheath. Sufficient control of the implant is needed for manipulation inside the joint space. Additionally, a secure yet releasable connection between the delivery device and the implant is needed to successfully complete the procedure. 
     It is noted that although the disclosure below is in reference to treatment of a tendon of the shoulder joint, it is contemplated and within the understanding of this disclosure that the implants, delivery devices, and uses thereof, are also applicable to other body joints, such as the hip, knee, and elbow, as well as other regions of the body. 
       FIG.  1    shows a cross-sectional view of a shoulder  10  including an example implant  12 . Shoulder  10  further shows a head  14  of humerus  16  mating with a glenoid fossa  19  of scapula  20 . The glenoid fossa  19  comprises a shallow depression in scapula  20 . A supraspinatus tendon  22  is also shown. These muscles (along with others) control the movement of humerus  16  relative to scapula  20 . A distal tendon  24  of supraspinatus tendon  22  meets humerus  16  at an insertion point  26 . 
     In  FIG.  1   , tendon  24  includes a damaged portion  28  located near insertion point  26 . Damaged portion  28  includes a tear  30  extending partially through tendon  24 . Tear  30  may be referred to as a partial thickness tear. However, in other instances the tear  30  may be a full thickness tear. The depicted partial thickness tear  30  is on the bursal side of the tendon, however, the tear may also be on the opposite or articular side of the tendon  24  and/or may include internal tears to the tendon  24  not visible on either surface. 
       FIG.  1    further illustrates that the tendon repair implant  12  has been placed over the partial thickness tear  30 . In this example, the tendon repair implant  12  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  12  may overlay multiple tears. 
     In some instances, delivery of an implant  12  (e.g., a sheet-like, one-piece planar 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 or otherwise deploy the implant adjacent the target implant site. 
     For example,  FIG.  2    provides a perspective view of an implant delivery system  40  extending through the shoulder  10  of a patient.  FIG.  2    shows implant delivery system  40  deployed adjacent a target site (e.g., a tear in the supraspinatus tendon). The implant delivery system  40  may be substantially similar to the implant delivery system disclosed in U.S. Pat. No. 10,314,689, herein incorporated by reference in its entirety. In at least some embodiments, implant delivery system  40  comprises a delivery sheath  42  (e.g., a cannula) including a proximal portion (not shown), a distal end  48  and a lumen extending within at least a portion of delivery sheath  42 . Further, implant delivery system  40  may include a delivery shaft  44  extending within the lumen of delivery sheath  42  and longitudinally movable relative thereto. 
     Delivery shaft  44  may include a proximal portion (not shown) extending out of the proximal portion of delivery sheath  42  and/or otherwise manipulatable relative to delivery sheath  42  by a user. Additionally, in some examples the proximal portion of delivery shaft  44  and/or or delivery sheath  42  may be coupled to a handle member (not shown). The handle member may be utilized to manipulate delivery shaft  44 . For example, the handle member may be utilized to impart a rotational and/or longitudinal force to delivery shaft  44 . 
     In addition, delivery shaft  44  may include a distal portion  50  extending out of the distal end  48  of delivery sheath  42 . Further, delivery shaft  44  may include a lumen extending therein. The lumen of delivery shaft  44  may extend along a portion or the entire length of delivery shaft  44  (e.g., from distal portion  50  to the proximal portion of delivery shaft  44 ). 
     Delivery system  40  may further include a frame  46  coupled to the distal portion  50  of the delivery shaft  44 . In some examples, the frame  46  may be fixedly mounted to the delivery shaft  44 . As shown in  FIG.  2   , frame  46  may be detachably coupled to an implant  12  (e.g., a sheet-like, planar implant). For purposes of the discussion herein, the combined structure including frame  46  and implant  12  may be defined as having a proximal portion  52  and a distal portion  54  as illustrated in  FIG.  2   . 
     When initially positioning the frame  46  and implant  12  adjacent a target site, a clinician may orient the frame  46  and implant  12  (for example, via a handle member attached to a proximal portion of the delivery shaft  44 ) such that the proximal portion  52  may be adjacent (e.g., overlaid) on a portion of the humerus (e.g., on the bone), while the distal portion  54  of the frame  46  and implant  12  may overlay the tendon  24 . 
     As described above, delivery of implant delivery system  40  may include the insertion of delivery sheath  42  through an access site (e.g., incision) and advancement to a target site. After positioning the distal end  48  of delivery sheath  42  proximate the target site, a clinician may deploy the frame  46  in combination with the implant  12  out of the lumen located within and along the distal end  48  of the delivery sheath  42 , such as by retracting delivery sheath  42  relative to delivery shaft  44  and frame  46 , and positioning implant  12  and frame  46  over the target site. 
     Prior to deployment, the frame  46  and implant  12  combination may be contained (e.g., housed) within the lumen of delivery sheath  42  for subsequent deployment distally out distal opening of delivery sheath  42 . As will be described in greater detail below, the combination of frame  46  and implant  12  may wrap and/or fold upon itself such that it may be positioned within the lumen of the delivery sheath  42 . Alternatively, frame  46  and implant  12  may wrap and/or fold around implant delivery shaft  44  while disposed within delivery sheath  42 . For example, frame  46  may be formed of a flexible material, such as a flexible polymer or metal material, capable of undergoing elastic deformation to collapse frame  46  for placement within the lumen of the delivery sheath  42 . 
       FIG.  3    shows an example frame  46  coupled to example implant  12 . As stated above with reference to  FIG.  2   , frame  46  and implant  12  may have a proximal portion  52  which, for purposes of discussion herein, may be adjacent delivery shaft  44  and be configured to be positioned adjacent humerus  16 . Further, frame  46  and implant  12  may have a distal portion  54  which, for purposes of discussion herein, may extend away from delivery shaft  44  and be configured to be positioned adjacent tendon  24 . 
       FIG.  3    further shows fastening regions  15  located at various positions within implant  12 . As shown in  FIG.  3   , the fastening regions  15  are positioned at locations which are free from the structure of frame  46 . In other words, the shape of frame  46  may be designed to specifically permit fastening implant  12 , such as with staples, to the anatomy at fastening regions  15  while frame overlies and is secured to implant  12 . 
     As shown in  FIG.  3   , frame  46  may include a body portion  56 , first arm  60  and second arm  64 . The body portion  56  may be positionable along a central portion of the implant  12  with first and second arms  60 ,  64  extending laterally from the body portion  56  in opposite directions toward opposite side edges of the implant  12 . The first arm  60  may have a first end  61 , or base, attached to the body portion  56  and a second, free end  62  opposite the first end  61 . The second arm  64  may have a first end  65 , or base, attached to the body portion  56  and a second, free end  66  opposite the first end  65 . In some embodiments, first and second arms  64  may diverge away from the body portion  56  at a convergence point at the base of first and second arms  60 ,  64 . In the example illustrated in  FIG.  3   , the body portion  56  and first and second arms  60 ,  64  define a Y shape. In other examples, the frame  46  may define a U shape. Alternatively, the second ends of the arms may be joined, forming a triangle, other polygon, circle, oval, or any desired shape. In some examples, the first and second arms  60 ,  64  may each have a fixed length and be fixed to the body portion  56 . Arms  60 ,  64  and body portion  56  may be formed as a single, monolithic structure, or arms  60 ,  64  may be formed separate from body portion  56  and thereafter be joined to the body portion  56 , if desired. In some instances, the body portion  56  may include an aperture  63 . As will be discussed in greater detail below, aperture  63  may be utilized to attach the frame  46  to the delivery shaft  44 . 
     In some examples (such as that shown in  FIG.  3   ), first and second arms  60 ,  64  may form a monolithic structure with body portion  56 . In other words, in some examples body portion  56 , first arm  60 , and second arm  64  may be formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) from a single piece of material. In some examples, the frame  46  may be made of a superelastic and/or shape memory material such as nitinol. However, the above discussion is not intended to be limiting. Rather, it is contemplated that frame  46  may be constructed using alternative materials and/or manufacturing methodologies. For example, frame  46 , or portions thereof, may be constructed from a polymeric material, a ceramic material and/or other various materials. Additionally, frame  46  may be manufactured via an injection molding or alternative polymer manufacturing methodologies. Alternatively, frame  46  may be formed through a 3-D printing process, if desired. Further, different portions of frame  46  (as described above, for example), may be made from a variety of materials and combined using alternative methodologies. For example, first and second arms  60 ,  64  may be made from a polymer material and combined with a body portion  56  constructed from a metal. Variations of combining different materials with different portions of frame  46  are contemplated. 
     The frame  46  may include a plurality of attachment members configured to releasably couple with the implant  12 . The first arm  60  may have a first tab  70  disposed adjacent its free end  62 , the second arm  64  may have a second tab  72  disposed adjacent its free end  66 , and the body portion  56  having a third tab  74 . In some instances, first arm  60  may include a plurality of first tabs  70  arranged along a length of the first arm  60  and/or second arm  64  may include a plurality of second arms  72  arranged along a length of the second arm  64 . In some examples, the first, second, and third tabs  70 ,  72 ,  74  may include barbs or projections having a sharp tip configured to pierce and extend at least partially through the implant  12 . In some instances the first, second and/or third tab  70 ,  72 ,  74  may extend entirely through the implant  12  to be exposed on a lower surface of the implant  12 . However, in other instances the first, second and/or third tab  70 ,  72 ,  74  may extend only partially through the thickness of the implant  12 , and thus not be exposed on the lower surface of the implant  12 . 
     In the example illustrated in  FIG.  3   , the first, second, and third tabs  70 ,  72 ,  74  are defined by cut-out portions of the frame  46 . Thus, the arms  60 ,  64  and/or base  56  may include openings where the tabs  70 ,  72 ,  74  are cut from the material forming the arms  60   64  and/or base  56  when the tabs  70 ,  72 ,  74  are bent out of plane from the arms  60 ,  64  and/or base  56 . In other examples, the first, second, and third tabs  70 ,  72 ,  74  may be formed separately and fixed to the frame  46 . The first, second, and third tabs  70 ,  72 ,  74  may extend in different directions. As shown in  FIG.  3   , the free end (e.g., pointed end) of the first tab  70  extends toward the free end  62  of the first arm  60  and thus toward the distal end of the implant  12 , the free end (e.g., pointed end) of the second tab  72  extends toward the body portion  56  and thus toward the proximal end of the implant  12 , and the free end (e.g., pointed end) of the third tab  74  extends toward the free ends  62 ,  66  of the first and second arms  60 ,  64  and thus toward the distal end of the implant  12 . Thus, the first tab  70  and the second tab  72  may be arranged to extend in generally opposite directions and/or may be arranged to extend toward opposite ends of the implant  12 . In embodiments in which the first arm  60  includes a plurality of first tabs  70 , each of the first tabs  70  may extend toward the free end  62  of the first arm and thus toward the distal end of the implant  12 , if desired. In embodiments in which the second arm  64  includes a plurality of second tabs  72 , each of the second tabs  72  may extend toward the body portion  56  and thus toward the proximal end of the implant  12 , if desired. 
     In the example shown in  FIG.  3   , the third tab  74  has a rounded or blunt end and does not pierce the implant  12 . Instead, the tab  74  is configured to grasp, wrap around or otherwise engage the proximal edge  17  of the implant  12 . In other examples, the third tab  74  may have a sharp tip piercing and extending at least partially through the implant  12 . The first and second arms  60 ,  64  may extend at an angle from the body portion  56  such that when the third tab  74  engages the edge  17  of the implant, the free ends of the first and second arms  60 ,  64  are disposed adjacent opposing edges of the implant  12 . In some instances, first and second tabs  70 ,  72  may extend through implant  12  from the first side of implant  12  to the second side of implant  12 . As illustrated, the first, second, and third tabs  70 ,  72 ,  74  extend downward from the lower surface  68  of the frame  46  which is juxtaposed with an upper surface of the implant  12 . The upper surface  69  of the frame  46  may be devoid of any raised structures. The first, second, and third tabs  70 ,  72 ,  74  may be angled at an oblique angle relative to the frame  46 , as illustrated in  FIGS.  4 A and  4 B , in order to secure the implant  12  to the frame  46 . 
     In some instances, one or more of the first, second, and third tabs  70 ,  72 ,  74  may be made of a superelastic and/or shape memory material, such as nitinol, configured to provide a secure grip on the implant  12  during delivery, but to be pulled free of the implant  12  without damaging the implant  12  as a withdrawal force is applied to frame  46 . While a single tab is shown on each of the first and second arms  60 ,  64 , it is contemplated that two or more tabs may be disposed on each arm. When multiple tabs are present on a single arm, the tabs may extend in the same direction or they may extend in opposite directions. In other words, in some instances, the first arm  60  may include one or more tabs having a free end (e.g., pointed end) extending toward the proximal end of the implant  12  and one or more tabs having a free end (e.g., pointed end) extending toward the distal end of the implant  12 . Likewise, the second arm  64  may include one or more tabs having a free end (e.g., pointed end) extending toward the proximal end of the implant  12  and one or more tabs having a free end (e.g., pointed end) extending toward the distal end of the implant  12 . 
     As stated above, it is contemplated in the examples discussed herein that frame  46  may be able to be detached from implant  12  upon securement of the implant  12  at a treatment site. For example, frame  46  may be configured to detach from implant  12  after implant  12  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  46  may be temporarily attached to implant  12 . For example, frame  46  may be coupled, affixed or attached to implant  12  while positioned within delivery sheath  42 , deployed out of delivery sheath  42  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  12  may be securely affixed to the target site, such as stapled and/or sutured to bone and/or tendon tissue at the target site. However, once implant  12  has been securely affixed to the target site, frame  46  may be pulled away (e.g., detached) from implant  12  and removed from the body. The first and second tabs  70 ,  72  may be configured to be detached or disengaged from implant  12  upon application of a threshold level of force. For example, the second tab  72  shown in  FIG.  4 A  may provide frame  46  the ability to detach from implant  12  when a threshold “pull-away force” is applied to frame  46 . For example, after implant  12  is affixed to a target site, a clinician may apply a force to frame  46  such that frame  46  is pulled away from implant  12 . Provided the force is great enough (e.g., the threshold force is met), the first tab  70  and second tab  72  may be pulled back through the thickness of implant  12  as the third tab  74  disengages the edge  17  of the implant  12 , thereby releasing frame  46  from implant  12 . 
       FIG.  4 A  shows the frame  46  coupled to the implant  12  via second and third tabs  72 ,  74  as described above. Further,  FIG.  4 A  shows frame  46  in combination with implant  12  coupled to an implant delivery shaft  44  extending through a delivery sheath  42 . In some instances, delivery shaft  44  may be attached to the body portion  56  of frame  46  via a first connection member  90 . The first connection member  90  may attach to body portion  56  via the aperture  63  (shown in  FIG.  3   ). In some instances, the first connection member  90  may be attached to the body portion  56  of frame  46  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  40  (including a delivery sheath  42 , delivery shaft  44 , frame  46  and implant  12 ) through an incision and position the distal end of the implant delivery system  40  adjacent a target implant site (e.g., torn tendon). Once adjacent the target site, the physician may manipulate the implant delivery shaft  44  to advance the implant (while attached to the detachable frame  46 ) out of the delivery sheath  42  adjacent the target implant site. For example, the physician may retract delivery sheath  42  proximally relative to delivery shaft  44  and frame  46  and/or may advance delivery shaft  44  and frame  46  distally relative to delivery sheath  42 . 
       FIG.  4 A  shows frame  46  and implant  12  deployed from the distal end of delivery sheath  42 . In some instances, frame  46  may have a substantially concave shape with respect to delivery sheath  42 . The concave curve may extend between the body portion  56  and the free ends  62 ,  66  of the first and second arms  60 ,  64 . It can be appreciated that the concave shape of frame  46  may facilitate positioning the implant  12  along the generally rounded shape of the human shoulder, as shown in  FIG.  2   . 
     However, when positioned in the delivery sheath  42  (e.g., prior to deployment) the frame  46  and implant  12  may be wrapped around the delivery shaft  44  in a convex configuration. Therefore, frame  46  and implant  12  may shift from a first convex configuration (while wrapped tightly around delivery shaft  44  within the lumen of delivery sheath  42 ) to a second concave configuration when advanced (e.g., deployed) out of delivery sheath  42 . 
     In other words, frame  46  and implant  12  may be attached to the delivery shaft  44  when positioned within the lumen of the delivery sheath  42 . In one example, when positioned within the delivery sheath  42 , the frame  46  and implant  12  may wrap, or extend around, the delivery shaft  44 . The position of the frame  46  and implant  12  may be in a convex, or rolled up configuration with respect to the distal portion  50  of the delivery shaft  44 . As the frame  46  and implant  12  are deployed out of the distal end of the delivery sheath  42 , the frame  46  and implant  12  may “shift” from a convex configuration to a concave configuration (as viewed with respect to the distal portion  50  of delivery shaft  44 ). Additionally,  FIG.  4 A  shows a tack member  94  extending through a portion of frame  46  such that the distal tip of tack member  94  would penetrate the head  14  of the humerus  16 . In some examples, the tack member  94  may extend through the aperture  63  in the body portion  56  (see  FIG.  3   ), and/or extend from a connection member secured to the aperture  63 . Tack member  94  will be described in greater detail below. 
     In some instances, the configuration of frame  46  shown in  FIGS.  3 ,  4 A, and  4 B  may provide both precise control and maneuverability to a clinician or other operator of the medical device. The delivery shaft  44  may be able to impart a downward force (e.g., a force directed toward a patient&#39;s shoulder) and/or rotational force onto frame  46  via the first connection member  90 . Further, the concave geometry of frame  46  may allow the distal portion  54  of frame  46  to extend along the surface of the shoulder for which the implant  12  is to be positioned. In other words, the geometry of frame  46  shown in  FIGS.  4 A and  4 B  may prevent the distal portion  54  of frame  46  (including free ends  62 ,  66  of arms  60 ,  64 ) from pulling up and away from the shoulder surface as a clinician manipulates frame  46  within the body. Further, the geometry of frame  46  may allow the distal portion  54  of frame  46  to be advanced toward the surface of the shoulder in which an implant  12  is to be positioned. 
     As briefly described above, any of the implant delivery systems described herein may include a tack member  94  designed to anchor the delivery system in place prior to a clinician affixing implant  12  to the bone and/or tendon. As shown in  FIG.  4 A , a tack member  94  extends distally from the first connection member  90 . The tack member  94  may extend distally from the first connection member  90  and be substantially perpendicular to implant  12  and/or frame  46 . The tack member  94  may be aligned along the central longitudinal axis of the delivery shaft  44 . In some instances, tack member  94  may resemble a cylindrical pin or rod extending away from frame  46 . The tack member  94  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  40  (e.g., delivery shaft  44 ) such that tack member  94  may be “hammered” into a body structure (e.g., bone). In some instances, tack member  94  may include a tapered distal tip, which may be a sharpened or blunt tapered distal tip in some instances. The tack member  94  may include one or more flanges proximal of the distal tip. In some instances, tack member  94  may be stationary (e.g., fixed in place) relative to frame  46  and/or first connection member  90 . In other instances, the tack member  94  may be retractable. The tack member  94  may be fixed to the frame  46  or may be removably attached to the frame  46 . 
     In some examples, frame  46  and implant  12  may be positioned within delivery sheath  42  (depicted as dashed line) as shown in  FIG.  5 A .  FIG.  5 A  shows frame  46  (with implant  12 ) substantially aligned longitudinally with delivery shaft  44  and tack member  94 . In this example, the distal portion  54  of frame  46  and implant  12  may be located distal of tack member  94  within delivery sheath  42 , and thus are the first portion of delivery system  40  that exits the distal end  48  of delivery sheath  42  when the frame  46  and delivery shaft  44  are advanced out of the delivery sheath  42  upon deployment of the delivery system  40 . In some examples, the frame  46  may be constrained into a rolled up shape within the lumen of the delivery sheath  42 , however upon being advanced out of the delivery sheath  42 , the frame  46  may resume its biased, curved shape, as shown in  FIGS.  4 A and  4 B . 
     Additionally,  FIG.  5 B  illustrates that implant  12  may be rolled up and positioned between frame  46  and the delivery sheath  42 . Upon exiting the distal end of delivery sheath  42 , implant  12  may unwrap to a configuration illustrated in  FIG.  3    and  FIGS.  4 A and  4 B .  FIG.  6    illustrates delivery system  40  with attached frame  46  and implant  12  after being maneuvered and/or positioned adjacent an example target site. The proximal portion  52  of the frame  46  is positioned adjacent the humeral head  16  with the tack member  94  driven into the humeral head  16 . In this position, the distal portion  54  of the frame  46  is positioned adjacent the tendon  24 , and the implant  12  is positioned over the tear  30  in the tendon  24 . 
     In other examples, tack member  94  may translate (e.g., slide, move, etc.) along a longitudinal axis within a lumen (not shown) of first connection member  90  of connection assembly  88 . For example,  FIG.  7    shows example delivery system  40  positioned adjacent an example target site with the proximal portion  52  of the frame  46  (along with implant  12 ) positioned adjacent the humeral head  16 . In this position, the distal portion  54  of the frame  46  is positioned adjacent the tendon  24 .  FIG.  7    further illustrates that the tack member  94  has not been advanced and/or extended out of the first connection member  90  of connection assembly  88  and driven into the humeral head. Rather, the tack member  94  remains positioned within the connection assembly  88  (e.g., positioned within first connection member  90 ). However, in some examples contemplated herein, tack member  94  may be advanced out of the distal portion of delivery shaft  44  and/or connection assembly  88 . In other words, the tack member  94  translates (e.g., slides, moves, etc.) relative to connection assembly  88  and advances away from the distal portion  50  of delivery shaft  44 . Once the delivery shaft  44  (along with frame  46  and implant  12 ) has been maneuvered and/or positioned adjacent an example target site, as shown in  FIG.  7   , the tack member  94  may be advanced out of the distal portion  50  of delivery shaft  44 . Once the tack member  94  has been advanced out of the distal portion  50  of the delivery shaft  44  (e.g., advanced distally of first connection member  90 ) and into the humeral head  16 , the device is in the position as shown in  FIG.  6   . The tack member  94  may be advanced out of the distal portion  50  of delivery shaft  44  via the application of a force at the proximal end of the delivery system  40  and/or actuation of an actuation mechanism to move tack member  94  relative to first connection member  90 . In some instances, a handle component may be utilized to generate a force to advance tack member  94  along a longitudinal axis of delivery shaft  44  and exit the distal portion  50  of delivery shaft  44  distal of first connection member  90 . 
     In some instances, once tack member  94  has been anchored into a target site (e.g., humeral head  16 ) it may be desirable to remove the delivery shaft  44  to make room for additional instruments to be advanced adjacent the target site.  FIG.  8    illustrates removing delivery shaft  44  from the target site (depicted by the arrow in  FIG.  8   ) while the frame  46  and implant  12  remain anchored to the humeral head  16  via the tack member  94 . As discussed above, delivery shaft  44  may be detached from frame  46  via uncoupling (e.g., detaching) a second connection member  92  from the first connection member  90 . In some instances, it may be desirable to reengage delivery shaft  44  after detaching second connection member  92  from first connection member  90 . For example, in some instances, the bone (e.g., humeral head) in which tack member  94  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 delivery shaft  44  to frame  46  via re-coupling second connection member  92  to first connection member  90 , such as after implant  12  has been attached to a target site via one or more bone and/or tendon staples, as described below. Alternatively, delivery shaft  44  may remain engaged to frame  46  while attaching implant  12  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  46  and/or tack member  94  when attaching implant  12  to an example target site via one or more bone and/or tendon staples. 
     In some instances, delivery system  40  may include a tether  96  coupled to frame  46 . For example,  FIG.  8    shows tether  96  attached to first connection member  90 . However, it is contemplated that in some examples tether  96  may be coupled directly to frame  46  and/or any other suitable structure. Further, tether  96  may be a rigid structure (e.g., rod) or it may be a non-rigid structure (e.g., a wire, cable, suture, etc.). Additionally, it can be appreciated that tether  96  may be long enough to extend from frame  46  positioned at the target site to a location exterior of the patient through insertion site (i.e., incision), such as through a lumen  86  of delivery shaft  44  and out of a proximal portion of the implant delivery system  40  (e.g., proximal portion of delivery shaft  44 ). The tether  96  may be fixedly attached to the frame  46  such that the tether remains attached to the frame when the delivery shaft  44  is detached from the frame  46 . 
     Further, it can be appreciated that tether  96  may remain attached to frame  46  (e.g., via first connection member  90 ) and extend to a location exterior of the patient through insertion site (i.e., incision) with delivery shaft  44  detached from frame  46  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.  9    shows a medical instrument  98  (e.g., implant stapler) positioned adjacent the proximal portion  52  of the frame  46  and implant  12 . As discussed above and shown in  FIG.  8   , tether  96  remains attached to frame  46  (e.g., via first connection member  90 ) and is positioned exterior of and alongside example medical instrument  98 . The medical instrument  98  may be used to attach implant  12  to treatment site, such as with one or more, or a plurality of staples and/or sutures. 
     As discussed above, in some instances, implant  12  may be affixed to a target site after which the frame  46  may be detached (and removed) from both implant  12  and the target site. For example, in some instances, implant  12  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  98 ). 
     Further, in some instances, it may be beneficial to affix implant  12  to the bone portion of the target site (e.g., humeral head  16 ) prior to affixing the implant to the tendon portion  24  of the target site. For example, it may be beneficial for a clinician to orient and/or position the frame  46  and implant  12  in the location/arrangement shown in  FIG.  9    prior to affixing the implant to the target site. As shown in  FIG.  9    (and previously discussed) the implant  12  is positioned such that the proximal portion  52  of the frame  46  and implant  12  are positioned adjacent the humeral head  16 , while the distal portion  54  is positioned adjacent the tendon  24 . Once the frame  46  and implant  12  have been placed appropriately, it may be desirable to utilize a stapling instrument to first insert staples along the proximal portion  52  of the implant  12  (e.g., the portion of the implant  12  positioned adjacent the bone) and into bone, followed by insertion of staples along the sides and distal portion of implant  12  and into tendon tissue. 
     It can be further appreciated that because the examples disclosed herein allow for the removal of the delivery sheath  42  and delivery shaft  44  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  52  of the implant  12  adjacent the humeral head  16 . Further, as discussed above, the frame  46  is shaped to allow access to fastening regions  15  (shown in  FIG.  3   ) of the implant  12  so the implant  12  may be stapled without removing the frame  46 . 
     Additionally, as discussed above, the tack member  94  may anchor the frame  46  and implant  12  in place (e.g., to the bone  16 ), thereby allowing a clinician to remove the delivery shaft  44  without fear that the frame/implant  46 / 12  combination will change position prior to the insertion of staples into the implant  12 . 
     Once the implant  12  has been sufficiently affixed to the target site, the clinician may detach the frame  46  from the implant  12  (within the body) and remove it from the body via the insertion site. For example,  FIG.  10    shows the detachment and removal of the frame  46  from the implant  12  (within the body) after the implant  12  has been affixed (e.g., via staples) to the target site. In some instances, the clinician may detach and remove frame  46  from the implant  12  and the body via application of a withdrawal force to the frame  46 . The withdrawal force may be applied via the tether  96 . For example, a clinician may pull on the tether  96  (the proximal end of which may be positioned outside of the body), thereby applying a withdrawal force to frame  46 . Once the withdrawal force reaches a threshold level (as discussed above), the first, second, and third tabs  70 ,  72 ,  74  on the frame  46  will detach from implant  12 . Further withdrawal of the tether  96  may be continued to pull frame  46  out of the body via the insertion site. 
       FIG.  11    illustrates another example frame  146  for releasably holding a sheet-like or planar implant  12 . The frame  146  is similar to the frame  46  shown in  FIG.  3   , except that instead of first and second tabs  70 ,  72  on arms  60 ,  64  securing the implant  12 , as in  FIG.  3   , the free end  162  on the first arm  160  and the free end  166  on the second arm  164  of the frame  146  are bent to define first and second tabs configured to removably attached to the implant  12  by wrapping around edges (e.g. wrapping around opposing side edges  18 ) of the implant  12 . When the first and second arms  160 ,  164  are disposed on and juxtaposed with an upper surface of a planar implant  12 , the free ends  162 ,  166  of the first and second arms  160 ,  164  wrap around side edges  18  of the implant  12  and extend along and face a lower surface of the implant  12 . The implant  12  may be grasped between the free ends  162 ,  166  (on the lower surface of the implant  12 ) and the medial portion of the first and second arms  160 ,  164  (on the upper surface of the implant  12 ). 
     The implant  12  shown in  FIG.  11    is rectangular, with the free ends  162 ,  166  wrapping around and clamping the opposing side edges  18  of the implant  12 . Similar to the frame  46  shown in  FIG.  3   , frame  146  has a tab  174  disposed on the body portion  156  of the frame  146  that is configured to grasp or be juxtaposed with lower edge  17  of the implant  12 . When the tab  174  engages one edge  17  of the implant  12 , the free ends  162 ,  166  of the first and second arms  160 ,  164  are disposed adjacent opposing side edges  18  of the implant  12 . For example, when the implant  12  is a polygon and the tab  174  engages a first edge  17  of the implant  12 , the first and second free ends  162 ,  166  of the first and second arms  160 ,  164  are configured to engage (e.g., wrap around) second and third opposing side edges  18  of the implant  12 . In instances in which the implant  12  is circular and the tab  174  may engage a first location on the edge of the implant  12 , the first and second free ends  162 ,  166  of the first and second arms  160 ,  164  are configured to engage (e.g., wrap around) second and third locations on the edge of the implant  12  spaced apart from the first location. 
     The frame  146 , coupled to the implant  12 , may be secured to a delivery system  40  including a delivery shaft  44 , as described above. The free ends  162 ,  166  and tab  174  combine to securely hold the implant  12  during delivery, yet allow for the frame  146  to be pulled free of the implant  12  after the implant  12  has been stapled or otherwise secured within the body. 
     Another example frame  246  for delivering the implant  12  is illustrated in  FIG.  12   . The frame  246  is configured to be releasably attached to the implant  12 . The frame  246  may include a body portion  256 , a first arm  260  and a second arm  264  extending from the body portion  256 . The body portion  256  may be positionable along a central portion of the implant  12  with first and second arms  260 ,  264  extending laterally from the body portion  256  in opposite directions toward opposite side edges of the implant  12 . In some examples, the first and second arms  260 ,  264  have free ends  262 ,  266  including a sharp distal tip  270 ,  272  and a flared region  271 ,  273  proximal of the sharp distal tip  270 ,  272  configured to penetrate the implant  12  when inserted through the implant  12  in a first direction, and to resist withdrawal from the implant  12  when pulled in a second direction opposite the first direction. The flared region  271 ,  273  may have a width larger than a width of the arm  260 ,  264  immediately proximal of the flared region  271 ,  273  to define a shoulder portion. The first and second arms  260 ,  264  may be woven into and out of the implant  12 , as shown in  FIG.  12   . The first and second arms  260 ,  264  may be fixed to the body portion  256  and may have a fixed length. In some examples, the entire frame  246 , including the body portion  256  and first and second arms  260 ,  264 , is formed from as a single, monolithic piece. The first and second arms  260 ,  264  may have a fixed length. The first and second arms  260 ,  264  may diverge from the body portion  256 . For example, the body portion  256  and first and second arms  260 ,  264  may define a Y shape, as shown in  FIG.  12   . In some examples, the frame  246  may define a single concave arc between the body portion  256  and the free ends  262 ,  266  of the first and second arms  260 ,  264 , as shown in  FIG.  13 A . One example of the woven configuration of the first and second arms  260 ,  264  into and out of the implant  12  is illustrated in  FIG.  13 B . In some examples, the body portion  256  and first end  261  and free end  262  of each arm  260  lies along an upper surface of the implant  12  while a middle region  267  of each arm  260  lies along a lower surface of the implant  12 , as shown in  FIG.  13 B . 
     The frame  246  illustrated in  FIG.  12    is in the deployed state with the first and second arms  260 ,  264  extending at an oblique angle from the body portion  256 . The frame  246  may be attached to a delivery system including a delivery sheath  242  having a proximal end, a distal end, and a lumen extending therebetween, and a delivery shaft  244  extending within the lumen of delivery sheath  242  and longitudinally movable relative thereto. The frame  246  may be rigidly and fixedly attached to the distal end  245  of the delivery shaft  244 . In some examples, the implant  12  is deployed substantially in-line with the delivery shaft  244 . In other examples, the frame  246  may have a curve that matches a curved target site. Additionally, in some examples the proximal portion of delivery shaft  444  and/or or delivery sheath  242  may be coupled to a handle member (not shown). The handle member may be utilized to manipulate delivery shaft  244 . For example, the handle member may be utilized to impart a rotational and/or longitudinal force to delivery shaft  244  during deployment. 
     In the undeployed state, frame  246  may be configured to fit within the delivery sheath  242 . Accordingly, in such an example, each arm  260 ,  264  may deform in a manner to allow insertion of the frame  246  and attached implant  12  into delivery sheath  242 . Accordingly, the frame  246  may generally be flexible, and in the example of  FIG.  12   , each arm  260 ,  264  may bend, twist, fold, wrap or otherwise deform in order for the frame  246  to fit within the delivery sheath  242 , and to return to the deployed shape shown in  FIG.  12    when extended out of the delivery sheath  242 . 
     Although  FIG.  12    depicts the frame  246  having a Y shape, it will be understood that the frame  246  can be shaped in any number of different configurations. For instance, as illustrated in  FIG.  14   , the frame  346  includes multiple sets of arms that diverge from the main body  356 . The main body  356  may extend in a longitudinal direction from the inner shaft  344  and a plurality of appendages that extend away from the trunk at an angle.  FIG.  14    depicts frame  346  with a main body  356  and four arms  360   a ,  360   b ,  360   c ,  360   d  (collectively  360 ). The main body  356  may be positioned or juxtaposed along an upper surface of the implant  12 . The arms  360  may have a base attached to the main body  356  and also positioned or juxtaposed along the upper surface of the implant  12 . The arms  360  may have a free end ending in a sharp distal tip  370   a ,  370   b ,  370   c ,  370   d  (collectively  370 ) and a flared region  371   a ,  371   b ,  371   c ,  371   d  (collectively  371 ) proximal of the sharp distal tip  370 . The sharp distal tip  370  may be configured to penetrate the implant  12  when inserted through the implant  12  in a first direction, and the flared region  371  may resist withdrawal from the implant  12  when pulled in a second direction opposite the first direction. The arms  360  may be woven into and out of the implant, as shown in  FIG.  14   , with a medial portion  367   a ,  367   b ,  367   c ,  367   d  (collectively  367 ) of each arm  360  facing or juxtaposed with the lower surface of the implant  12 , opposite the upper surface. The distal tips  370  of the arms  360  may be positioned on and face the upper surface of the implant  12 . 
       FIG.  15    illustrates another example of an implant delivery system  400  that may be used to deliver an implant  12  to a target site in the body. The implant delivery system  400  may be substantially similar to the implant delivery system disclosed in U.S. Pat. No. 10,258,459, herein incorporated by reference in its entirety. The implant delivery system  400  may include a delivery sheath  442  and a delivery shaft  444  slidable within a lumen of the delivery sheath  442 . In some examples, first and second beams  480  may be fixed to the distal end  445  of the delivery shaft  444  and extending substantially parallel to the delivery shaft  444 . In the top view shown in  FIG.  15   , only the first beam  480  is shown extending over the implant  12 . The second beam mirrors the first beam  480  and extends below the implant  12  directly under the first beam  480 . The implant  12  may be disposed between the first and second beams  480 , and first and second beams  480  may releasably retain or grasp implant  12 . For instance, first and second beams  480  may passively retain implant  12  when implant  12  is positioned between first and second beams  480 , such as by contact forces between first and second beams  480  and implant  12 . Alternatively, first and second beams  480  may be biased towards each other, creating a gripping force to retain implant  12 . 
     The implant delivery system  400  may include an active retention mechanism to retain implant  12 . The active retention mechanism may require manipulation by a user to retain and/or release implant  12 . In some examples, the active retention mechanism may include a frame  446  releasably connected to delivery shaft  444 . In some examples, frame  446  may be fixed to the distal end  445  of delivery shaft  444  and extend substantially parallel to the delivery shaft  444 . In other examples, frame  446  may be fixed to first beam  480 , frame  446  may be incorporated with first beam  480 , or frame  446  may be positioned between first and second beams  480 . When implant  12  is disposed between first and second beams  480 , frame  446  may engage implant  12 . In other examples, the implant delivery system  400  does not include the first and second beams  480 . Instead, frame  446  alone may releasably engage the implant  12 . 
     The frame  446  may be similar to frame  246  described above, with first and second arms  460 ,  466  having sharp distal tips  470 ,  472  configured to penetrate implant  12  when inserted in a first direction and to resist withdrawal from implant  12  when pulled in a second direction opposite the first direction. The arms may be woven into and out of implant  12  as shown in  FIG.  15   . In some examples, first and second beams  480  and frame  446  may be fixed to the distal end  445  of delivery shaft  444  such that implant  12  extends generally parallel to the longitudinal axis of delivery shaft  444 . 
     In implant delivery system  400 , once implant  12  is moved out of delivery sheath  442 , implant  12  may extend generally parallel to the longitudinal axis of the delivery shaft  444 , as illustrated in  FIG.  15   . Implant delivery system  40  provides an alternative position for implant  12  in that once implant  12  is moved out of delivery sheath  42 , implant  12  extends at an angle, such as substantially perpendicular) to the longitudinal axis of the delivery shaft  44 , as illustrated in  FIG.  2   . The frames  46 ,  146 ,  246 ,  346 ,  446  may be connected to either of the implant delivery systems  40 ,  400 , depending on the desired angle/orientation/trajectory of delivery. 
     In the undeployed state, frame  46 ,  146 ,  246 ,  346 ,  446  may be configured to fit within delivery sheath  42 ,  242 ,  442 . Accordingly, in such an example, each arm of frame  46 ,  146 ,  246 ,  346 ,  446  may deform in a manner to allow insertion of frame  46 ,  146 ,  246 ,  346 ,  446  into delivery sheath  42 ,  242 ,  442 . Accordingly, frame  46 ,  146 ,  246 ,  346 ,  446  may generally be flexible, and each arm of frame  46 ,  146 ,  246 ,  346 ,  446  may bend, twist, fold, wrap or otherwise deform in order for frame  46 ,  146 ,  246 ,  346 ,  446  with attached implant  12  to fit within delivery sheath  42 ,  242 ,  442 . 
     In at least some examples, the frame  46 ,  146 ,  246 ,  346 ,  446  is made of a material that may deform elastically into one or more shapes in order to fit within the confines of delivery sheath  42 ,  242 ,  442 . Some suitable example materials include metals and metal alloys including stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material. 
     As alluded to above, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol. 
     In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming. 
     In some examples, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties. 
     In some examples, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties. 
     In other examples, implant positioning component may be constructed of one or more of the above described materials configured as an inlay. For instance, the frame  46 ,  146 ,  246 ,  346 ,  446  may comprise a metal structure encased in one or more other materials, such as a plastic or silicone material. The plastic or silicone material may be molded either completely or partly over the metal structure. Such hybrid-material structures may reduce the manufacturing cost of producing frame  46 ,  146 ,  246 ,  346 ,  446  or provide frame  46 ,  146 ,  246 ,  346 ,  446  with physical properties unable to be achieved by using only metal. 
     In the above examples, implant  12  may comprise one or multiple of a number of different materials without deviating from the spirit and scope of the present disclosure. In some examples, implant  12  may comprise a plurality of fibers. The fibers may be interlinked with one another. When this is the case, implant  12  may comprise a plurality of apertures comprising the interstitial spaces between fibers. Various processes may be used to interlink the fibers with one another. Examples of processes that may be suitable in some applications including weaving, knitting, and braiding. In some embodiments, implant  12  may comprise a laminate including multiple layers of film with each layer of film defining a plurality of micro-machined or formed holes. Implant  12  may also comprise a reconstituted collagen material having a porous structure. Additionally, implant  12  may also comprise a plurality of electro-spun nanofiber filaments forming a composite sheet. Additionally, implant  12  may comprise a synthetic sponge material that defines a plurality of pores. Implant  12  may also comprise a reticulated foam material. Implant  12  may be circular, oval, oblong, square, rectangular, triangular, or any other shape configured to suit the target anatomy. 
     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. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure&#39;s scope is, of course, defined in the language in which the appended claims are expressed.