Medical implant and implant frame

Abstract

An implant delivery system for delivering an implant to a body. The implant delivery system may include a delivery shaft including a proximal portion and a distal portion; and a removable frame coupled to the distal portion of the delivery shaft. The removable frame may include a body portion and a plurality of attachment arms extending away from the body portion. At least one soft tissue anchor may be releasably secured to a free end of at least one of the plurality of attachment arms and may be configured to releasably secure an implant to the removable frame.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. patent application Ser. No. 63 / 347,737, filed on Jun. 1, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present invention relates generally but not limited to orthopedic implants and treatment methods. More particularly, the present invention relates to systems and methods for delivering tendon repair implants, such as those engineered for arthroscopic placement over or in the area of ​​a full-thickness or partial-thickness tear of the supraspinatus tendon of the shoulder. Background Art

[0003] Due to its complexity, range of motion, and widespread use, a common soft tissue injury is that of the rotator cuff or rotator cuff tendon. Rotator cuff injury is a potentially serious condition that can occur due to an acute traumatic tear or overuse of the joint during hyperextension. There is a continuing need to deliver and adequately position medical implants during arthroscopic surgery in order to treat injuries to the rotator cuff, rotator cuff tendon, or other soft tissue or tendon injuries throughout the body. Summary of the invention

[0004] The present invention provides designs, materials, methods of manufacture, and use alternatives for implants used in soft tissue repair, such as, but not limited to, rotator cuff repair.

[0005] One example is an implant delivery system. The implant delivery system includes a delivery shaft including a proximal portion and a distal portion; and a frame coupled to the distal portion of the delivery shaft. The frame includes a body portion and a plurality of attachment arms extending away from the body portion. At least one soft tissue anchor is releasably secured to a free end of at least one of the plurality of attachment arms. The implant is releasably secured to the frame via the at least one soft tissue anchor.

[0006] Additionally or alternatively, in another example, at least one soft tissue anchor is configured to remain with the implant within the body.

[0007] Additionally or alternatively, in another example, the frame has a first surface configured to face away from the implant when the implant is secured to the frame and a second surface configured to face toward the implant when the implant is secured to the frame.

[0008] Additionally or alternatively, in another example, at least one tissue anchor includes a proximal head, a distal fixation end, and an intermediate connecting portion extending between the proximal head and the distal fixation end.

[0009] Additionally or alternatively, in another example, the proximal head is generally disc-shaped.

[0010] Additionally or alternatively, in another example, the distal fixation end includes a first barb and a second barb.

[0011] Additionally or alternatively, in another example, the intermediate connecting portion includes an elongated rod.

[0012] Additionally or alternatively, in another example, the proximal head is a frustoconical.

[0013] Additionally or alternatively, in another example, the distal fixation end has a barbed "U" shape including a first leg and a second leg.

[0014] Additionally or alternatively, in another example, the intermediate connecting portion forms a bridge between the first leg and the second leg.

[0015] Additionally or alternatively, in another example, the system further includes a recess formed in at least one of the plurality of attachment arms adjacent a free end thereof.

[0016] Additionally or alternatively, in another example, the recess extends partially through a thickness of at least one of the plurality of attachment arms to define an area of ​​reduced thickness.

[0017] Additionally or alternatively, in another example, the system further includes a through hole extending through the region of reduced thickness.

[0018] Additionally or alternatively, in another example, the recess is configured to receive a proximal head of at least one soft tissue anchor therein.

[0019] Additionally or alternatively, in another example, the intermediate connecting portion extends through the through hole.

[0020] Additionally or alternatively, in another example, under an applied force, the proximal head of the at least one soft tissue anchor is configured to push through the region of reduced thickness of at least one of the plurality of attachment arms to release the at least one soft tissue anchor from the frame.

[0021] Additionally or alternatively, in another example, the area of ​​reduced thickness is configured to fracture.

[0022] Additionally or alternatively, in another example, the region of reduced thickness is configured to deform to allow the proximal head to pass through the through hole.

[0023] Additionally or alternatively, in another example, the proximal head further includes one or more radially extending lugs.

[0024] Additionally or alternatively, in another example, the system further includes a hole formed through at least one of the plurality of attachment arms adjacent a free end thereof.

[0025] Additionally or alternatively, in another example, the hole extends through a thickness of at least one of the plurality of attachment arms.

[0026] Additionally or alternatively, in another example, the system further includes a circumferentially extending groove formed in a sidewall of the aperture, the circumferentially extending groove positioned between a first surface of at least one of the plurality of attachment arms and a second surface of at least one of the plurality of attachment arms.

[0027] Additionally or alternatively, in another example, the system further includes at least one axially extending slot formed in a sidewall of the aperture, the at least one axially extending slot extending from the second surface of at least one of the plurality of attachment arms to the circumferentially extending groove.

[0028] Additionally or alternatively, in another example, during assembly of at least one soft tissue anchor with at least one of the plurality of attachment arms and deployment of at least one soft tissue anchor from at least one of the plurality of attachment arms, one or more radially extending lugs are configured to slide within at least one axially extending slot.

[0029] Additionally or alternatively, in another example, one or more radially extending lugs are rotatably disposed within a circumferentially extending groove during delivery of the implant to a target location.

[0030] Additionally or alternatively, in another example, the proximal head further includes one or more radially extending detents.

[0031] Additionally or alternatively, in another example, the detent extends around the circumference of the proximal head.

[0032] Additionally or alternatively, in another example, the system further includes a hole formed through at least one of the plurality of attachment arms adjacent a free end thereof.

[0033] Additionally or alternatively, in another example, the hole extends through a thickness of at least one of the plurality of attachment arms.

[0034] Additionally or alternatively, in another example, the system further includes a retainer configured to slide over a free end of at least one of the plurality of attachment arms.

[0035] Additionally or alternatively, in another example, the retainer includes a top side, a bottom side, a first lateral side extending between the top side and the bottom side, and a second lateral side opposite the first lateral side and extending between the top side and the bottom side.

[0036] Additionally or alternatively, in another example, the top side, the bottom side, the first lateral side, and the second lateral side collectively define a channel extending from the first end to the second end of the holder, the channel being configured to receive at least one of the plurality of attachment arms.

[0037] Additionally or alternatively, in another example, the system further includes a first opening in the top side of the holder and a second opening defined in the bottom side of the holder.

[0038] Additionally or alternatively, in another example, the first opening has a first diameter and the second opening has a second diameter, the second diameter being greater than the first diameter.

[0039] Additionally or alternatively, in another example, the first and second openings are substantially aligned to define a retainer aperture extending from the top side to the bottom side.

[0040] Additionally or alternatively, in another example, the retainer aperture is aligned with an aperture of at least one of the plurality of attachment arms.

[0041] Additionally or alternatively, in another example, one or more radially extending detents of the proximal head are received within mating recesses formed in a sidewall of the first opening of the retainer.

[0042] Additionally or alternatively, in another example, the system further includes a hole formed through at least one of the plurality of attachment arms adjacent a free end thereof.

[0043] Additionally or alternatively, in another example, the hole extends through a thickness of at least one of the plurality of attachment arms.

[0044] Additionally or alternatively, in another example, the system further includes a retainer configured to slide over a free end of at least one of the plurality of attachment arms.

[0045] Additionally or alternatively, in another example, the retainer includes a top side, a bottom side, a first lateral side extending between the top side and the bottom side, and a second lateral side opposite the first lateral side and extending between the top side and the bottom side.

[0046] Additionally or alternatively, in another example, the top side, the bottom side, the first lateral side, and the second lateral side collectively define a channel extending from the first end to the second end of the holder, the channel being configured to receive at least one of the plurality of attachment arms.

[0047] Additionally or alternatively, in another example, the system further includes a first opening in the top side of the holder and a second opening defined in the bottom side of the holder.

[0048] Additionally or alternatively, in another example, the first and second openings are substantially circular.

[0049] Additionally or alternatively, in another example, the first and second openings are substantially aligned to define a retainer aperture extending from the top side to the bottom side.

[0050] Additionally or alternatively, in another example, the first opening has a first diameter and the second opening has a second diameter, the second diameter being greater than the first diameter.

[0051] Additionally or alternatively, in another example, the first opening of the retainer has a first diameter that is smaller than a diameter of the proximal head of the at least one soft tissue anchor.

[0052] Additionally or alternatively, in another example, the retainer aperture is aligned with an aperture of at least one of the plurality of attachment arms.

[0053] Additionally or alternatively, in another example, the intermediate connecting portion is disposed within the retainer aperture, and the aperture of at least one of the plurality of attachment arms and a bottom surface of the proximal head region of the at least one soft tissue anchor engage a top side of the retainer.

[0054] Additionally or alternatively, in another example, the retainer is configured to break to release the at least one soft tissue anchor.

[0055] Additionally or alternatively, in another example, at least one of the plurality of attachment arms includes a first flexible arm and a second arm adjacent a free end thereof.

[0056] Additionally or alternatively, in another example, the widths of the first and second flexible arms increase toward the free ends to define a distal opening having a first width and a hole having a second width, the second width being greater than the first width.

[0057] Additionally or alternatively, in another example, the intermediate connecting portion is disposed within the hole.

[0058] Additionally or alternatively, in another example, the first and second flexible arms are configured to flex away from a longitudinal axis of at least one of the plurality of attachment arms to receive and deploy the at least one soft tissue anchor in response to an applied force.

[0059] Additionally or alternatively, in another example, in the absence of an applied force, the first and second arms are configured to return to an unbiased configuration.

[0060] Additionally or alternatively, in another example, the first and second arms are configured to engage a recess formed in a side wall of the proximal head.

[0061] Additionally or alternatively, in another example, the proximal head includes a top side, a bottom side, a first lateral side extending between the top side and the bottom side, and a second lateral side opposite the first lateral side and extending between the top side and the bottom side.

[0062] Additionally or alternatively, in another example, the top side, the bottom side, the first lateral side, and the second lateral side collectively define a channel extending from the first end to the second end of the proximal head, the channel being configured to receive at least one of the plurality of attachment arms.

[0063] Additionally or alternatively, in another example, the distal fixation end includes a first barb and a second barb.

[0064] Additionally or alternatively, in another example, the intermediate connecting portion includes an elongated rod.

[0065] Additionally or alternatively, in another example, at least one of the plurality of attachment arms includes a first flexible arm and a second flexible arm adjacent a free end thereof.

[0066] Additionally or alternatively, in another example, the first and second flexible arms define a gap therebetween.

[0067] Additionally or alternatively, in another example, the first and second flexible arms each include a proximal portion and a distal portion terminating in a free end, wherein the proximal portion extends substantially parallel to the longitudinal axis of at least one of the plurality of attachment arms, and the distal portion extends at a non-parallel angle to the longitudinal axis of at least one of the plurality of attachment arms.

[0068] Additionally or alternatively, in another example, the free ends of the first and second flexible arms can each be bent away from the longitudinal axis of at least one of the plurality of attachment arms such that a first width of at least one of the plurality of attachment arms adjacent the free end is greater than a second width of at least one of the plurality of attachment arms adjacent the proximal portion of the flexible arm.

[0069] Additionally or alternatively, in another example, the first and second flexible arms are configured to flex inwardly toward a longitudinal axis of at least one of the plurality of attachment arms under an applied force.

[0070] Additionally or alternatively, in another example, the first and second flexible arms are configured to flex inwardly to position the first and second flexible arms within a channel of a proximal head of at least one soft tissue anchor and deploy at least one soft tissue anchor from at least one of the plurality of attachment arms.

[0071] Additionally or alternatively, in another example, at least one of the plurality of attachment arms includes a raised detent extending from a surface thereof adjacent a free end.

[0072] Additionally or alternatively, in another example, the raised detent includes a distal side and a proximal side.

[0073] Additionally or alternatively, in another example, the height of the distal side of the raised detent increases in the proximal direction.

[0074] Additionally or alternatively, in another example, a proximal side of the raised detent extends at an angle normal to a surface of at least one of the plurality of attachment arms.

[0075] Additionally or alternatively, in another example, at least one of the plurality of attachment arms is disposed within a channel of a proximal head of at least one soft tissue anchor.

[0076] Additionally or alternatively, in another example, a raised detent is positioned outside of the channel adjacent the first end of the proximal head.

[0077] Additionally or alternatively, in another example, the raised detent is configured to deform when a lateral pulling force applied to the removable frame allows at least one of the plurality of attachment arms to pass through the passage of the proximal head of the at least one soft tissue anchor.

[0078] Additionally or alternatively, in another example, the proximal head further includes a first stop and a second stop extending from a top side or a bottom side of the proximal head into the channel.

[0079] Additionally or alternatively, in another example, at least one of the plurality of attachment arms includes a first recess and a second recess formed in a surface thereof, the second recess being laterally spaced apart from the first recess.

[0080] Additionally or alternatively, in another example, the first and second detents of the proximal head are configured to cooperate with the first and second recesses of at least one of the plurality of attachment arms when the at least one of the plurality of attachment arms is disposed within the channel of the proximal head.

[0081] Additionally or alternatively, in another example, the first and second detents are configured to disengage from the first and second recesses when lateral pulling force applied to the removable frame allows at least one of the plurality of attachment arms to pass through the passage of the proximal head of the at least one soft tissue anchor.

[0082] Additionally or alternatively, in another example, the system further includes a hole formed through at least one of the plurality of attachment arms adjacent a free end thereof.

[0083] Additionally or alternatively, in another example, the hole extends through a thickness of at least one of the plurality of attachment arms.

[0084] Additionally or alternatively, in another example, the aperture is generally rectangular.

[0085] Additionally or alternatively, in another example, the system further includes a retainer configured to slide over a free end of at least one of the plurality of attachment arms.

[0086] Additionally or alternatively, in another example, the retainer includes a top side, a bottom side, a first lateral side extending between the top side and the bottom side, and a second lateral side opposite the first lateral side and extending between the top side and the bottom side.

[0087] Additionally or alternatively, in another example, the top side, the bottom side, the first lateral side, and the second lateral side collectively define a channel extending from the first end to the second end of the holder, the channel being configured to receive at least one of the plurality of attachment arms.

[0088] Additionally or alternatively, in another example, the system further includes a first opening in the top side of the holder and a second opening defined in the bottom side of the holder.

[0089] Additionally or alternatively, in another example, the first and second openings are substantially aligned to define a retainer aperture extending from the top side to the bottom side.

[0090] Additionally or alternatively, in another example, the first opening has a first width and length, and the second opening has a second width and length, the second width and length being greater than the first width and length.

[0091] Additionally or alternatively, in another example, the first width and length of the first opening of the retainer are less than the width and length of the upper surface of the proximal head of the at least one soft tissue anchor.

[0092] Additionally or alternatively, in another example, the retainer aperture is aligned with an aperture of at least one of the plurality of attachment arms.

[0093] Additionally or alternatively, in another example, the intermediate connecting portion is disposed within the retainer aperture, and the aperture of at least one of the plurality of attachment arms and the plurality of side surfaces of the proximal head region of the at least one soft tissue anchor engage a top side of the retainer.

[0094] Additionally or alternatively, in another example, the retainer is configured to break to release the at least one soft tissue anchor.

[0095] Additionally or alternatively, in another example, the retainer is configured to flex to release the at least one soft tissue anchor.

[0096] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0097] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0098] Figure 1 A cross-section of a front view of a patient's shoulder is shown;

[0099] Figure 2 A shoulder is shown including a humeral head that fits into the socket of the scapula at the glenohumeral joint and an implant attached to a tendon;

[0100] Figure 3A An example implant delivery device attached to an implant is shown;

[0101] Figure 3B An example delivery device attached to an implant is shown;

[0102] Figure 3C An example delivery device attached to an implant is shown;

[0103] Figure 4 An example implant delivery device attached to an implant is shown;

[0104] Figure 5 An example frame attached to an example implant is shown;

[0105] Fig. 6A A detailed view of an illustrative soft tissue anchor assembled with a frame and implant is shown;

[0106] Figure 6B Shows Fig. 6A A cross-sectional view of an illustrative soft tissue anchor and attachment arm;

[0107] Fig. 7A an exploded perspective view showing another illustrative attachment arm of the frame and soft tissue anchor;

[0108] Figure 7B Shows Fig. 7A A cross-sectional view of an illustrative attachment arm;

[0109] Figure 7C Shown with Fig. 7A A top view of an illustrative attachment arm assembled together with the soft tissue anchor;

[0110] Fig. 8A showing a perspective view of another illustrative attachment arm of a frame and soft tissue anchor;

[0111] Figure 8B Shows Fig. 8A An exploded perspective view of a frame and an illustrative attachment arm of a soft tissue anchor;

[0112] Figure 8C Shows Fig. 8A A cross-sectional view of an illustrative attachment arm;

[0113] Fig.8D shows a cross-sectional view of an alternative retainer assembled with an attachment arm;

[0114] Fig. 8E shows a perspective view of the illustrative retainer of FIG. 8 after deployment of a soft tissue anchor from the retainer;

[0115] Fig.9A an exploded perspective view showing another illustrative attachment arm of the frame and soft tissue anchor;

[0116] Fig. 9B Shows Fig.9A a perspective view of an illustrative attachment arm;

[0117] Fig. 9C Shows that Fig.9A and Fig. 9B A cross-sectional view of an alternative soft tissue anchor for use with an attachment arm of;

[0118] Fig. 10A an exploded perspective view showing another illustrative attachment arm of the frame and soft tissue anchor;

[0119] Fig. 10B Shown with Fig. 10A a perspective view of an illustrative attachment arm of a framework assembled with soft tissue anchors;

[0120] Fig.11A an exploded perspective view showing another illustrative attachment arm of the frame and soft tissue anchor;

[0121] Fig. 11B Shown with Fig.11A A side view of an illustrative attachment arm of a frame with a soft tissue anchor and an implant assembled together;

[0122] Fig. 12A an exploded perspective view showing another illustrative attachment arm of the frame and soft tissue anchor;

[0123] Fig. 12B Shown with Fig. 12A A partial cross-sectional view of an illustrative attachment arm of a frame assembled together with a soft tissue anchor;

[0124] Fig.13A showing a perspective view of another illustrative attachment arm of a frame and soft tissue anchor;

[0125] Fig. 13BShows Fig.13A an exploded perspective view of an illustrative attachment arm of a frame, a retainer, and a soft tissue anchor; and

[0126] Fig. 13C yes Fig.13A A cross-sectional view of an illustrative attachment arm.

[0127] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0128] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0129] All numerical values ​​are assumed herein to be modified by the term "about", whether or not expressly indicated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the referenced value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0130] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0131] 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.

[0132] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures, or characteristics. However, such a description does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Additionally, when specific features, structures, and / or characteristics are described in conjunction with one embodiment, it should be understood that such features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0133] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0134] Due to its complexity, range of motion, and widespread use, a common soft tissue injury is an injury to the rotator cuff or rotator cuff tendon. Rotator cuff injury is a potentially serious condition that may occur during hyperextension, due to an acute traumatic tear, or due to overuse of the joint. Current repair surgeries may attempt to lessen the impact or make room for the tendon to move to prevent further injury and relieve discomfort, but will not repair or strengthen the tendon. Acceptable treatment for rotator cuff tears may include reattaching the torn tendon to the humeral head using sutures. In addition, when treating rotator cuff tears, acceptable practice may also include placing a stent on the repaired tendon to mechanically reinforce the repaired tendon. Therefore, there is a continued need to deliver and adequately position medical implants during arthroscopic surgery in order to treat injuries to the rotator cuff, rotator cuff tendon, or other soft tissue or tendon injuries throughout the body.

[0135] Figure 1 A cross-sectional view of a shoulder 10 including an example implant 12 is shown. The shoulder 10 also shows the head 14 of the humerus 16 mating with the glenoid fossa 18 of the scapula 20. The glenoid fossa 18 comprises a shallow depression in the scapula 20. The supraspinatus tendon 22 is also shown. These muscles (among other muscles) control the movement of the humerus 16 relative to the scapula 20. The distal tendon 24 of the supraspinatus 22 intersects the humerus 16 at the insertion point 26.

[0136] exist Figure 1 2, the distal tendon 24 includes a damaged portion 28 located near the insertion point 26. The damaged portion 28 includes a tear 30 that extends partially through the distal tendon 24. The tear 30 may be referred to as a partial thickness tear. The depicted partial thickness tear 30 is located on the bursa side of the tendon, however, the tear may also be located on the opposite side or the joint side of the distal tendon 24 and / or may include an internal tear of the distal tendon 24 that is not visible on any surface. In other cases, the tear 30 may be a full thickness tear.

[0137] Figure 1 Also shown is a tendon repair implant 12 that has been placed over a 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, the joint side, or within the tendon. In addition, the tendon repair implant 12 can cover multiple tears.

[0138] Although a possible treatment site is described as being located in the shoulder joint in the drawings, implant 12 can be used for various treatment sites, such as, hip joint, knee joint, ankle joint etc. In addition, implant 12 can be used for any of various soft tissue repairs, such as but not limited to gluteus medius (it is the large fan-shaped muscle located at the rear of the hip joint) and hip joint capsule (it is also located in the hip joint). Implant 12 can be used for treating the soft tissue injury in the knee joint, such as but not limited to ligament, such as ACL (anterior cruciate ligament), MCL (medial collateral ligament) and PCL (posterior cruciate ligament) and tendon, such as hamstring tendon, quadriceps tendon and patellar tendon. Implant 12 can be used for treating the soft tissue injury in the Achilles tendon. Implant 12 can be used for treating the soft tissue injury in any zone that holds implant 12 in the health.

[0139] In some cases, implant 12 (e.g., sheet implant) may be delivered to the target site of the patient and may require the physician to create an incision on the patient that is sufficient to enter the target implant site. After creating this "entry site", the physician can insert the implant delivery system through the entry site and position the distal end of the implant delivery system adjacent to the target implant site. Then, the physician can manipulate the implant delivery system to deploy the implant from the delivery sheath adjacent to the target implant site.

[0140] For example, Figure 2 A perspective view of an implant delivery system 40 extending through a patient's shoulder 10 is provided. Figure 2 An implant delivery system 40 is shown deployed adjacent a target site (e.g., a tear in the supraspinatus tendon). In at least some embodiments, the implant delivery system 40 includes a sheath member 42 (e.g., a cannula) including a proximal portion (not shown), a distal portion 48, and a lumen extending within at least a portion of the cannula 42. In addition, the implant delivery system 40 can include a delivery shaft 44 extending within the lumen of the sheath member 42 and movable longitudinally relative thereto.

[0141] The delivery shaft 44 can include a proximal portion that extends out of the sheath member 42 and / or a proximal portion (not shown) that can be manipulated by a user in other ways relative to the sheath member 42. Additionally, in some examples, the proximal portion of the delivery shaft 44 and / or the sheath member 44 can be coupled to a handle member (not shown). The handle member can be used to manipulate the delivery shaft 44. For example, the handle member can be used to apply a rotational force to the delivery shaft 44.

[0142] Additionally, the delivery shaft 44 can include a distal portion 50 extending from the distal portion 48 of the sheath member 42. Additionally, the delivery shaft 44 can include a lumen extending therein. The lumen of the delivery shaft 44 can extend along a portion or the entire length of the delivery shaft 44 (e.g., from the distal portion 50 to the proximal portion of the delivery shaft 44).

[0143] The delivery system 40 may also include a removable frame member 46 that is attached to a distal portion 50 of the delivery shaft 44 and, in some cases, may be removable from the delivery shaft 44. Figure 2 As shown, the removable frame 46 can be attached to the implant 12 (e.g., a sheet-like implant) for delivery to the implant site and subsequent placement thereon. For ease of discussion herein, the combined structure including the frame 46 and the implant 12 can be defined as having a proximal end 52 and a distal end 54, such as Figure 2 shown.

[0144] When initially positioning the frame 46 and implant 12 adjacent to a target site, the clinician can orient the frame 46 and implant 12 (e.g., via a handle member attached to the proximal portion of the delivery shaft 44) such that the proximal portion 52 (i.e., the lateral side portion) can be adjacent to (e.g., covering) a portion of the humerus (e.g., on a bone) and the distal portion 54 (i.e., the medial portion) of the frame 46 and implant 12 can cover the distal tendon 24.

[0145] As described above, the delivery of the implant delivery system 40 can include inserting a delivery sheath 42 through an entry site (e.g., an incision) and advancing to the target site. After the distal end 48 of the delivery sheath 42 is positioned proximal to the target site, the clinician can deploy the detachable frame 46 in combination with the implant 12 from a cavity, which is located in and along the distal portion 48 of the delivery sheath 42, such as by retracting the delivery sheath 42 relative to the delivery shaft 44 and the frame 46, and positioning the implant 12 and the frame 46 above the target site.

[0146] Prior to deployment, the combination of the removable frame 46 and the implant 12 can be contained (e.g., housed) within the lumen of the delivery sheath 42 for subsequent deployment distally from the distal opening of the delivery sheath 42. The combination of the removable frame 46 and the implant 12 can be wrapped and / or folded upon itself so that it can be positioned within the lumen of the delivery sheath 42. Alternatively, the removable frame 46 and the implant 12 can be wrapped and / or folded around the implant delivery shaft 44 while disposed within the delivery sheath 42.

[0147] In some cases, the removable frame 46 can be formed as an integral structure by forming (e.g., machining, cutting, forming, stamping, laser cutting, etc.) a single piece of material as an integral structure. It is conceivable that the removable frame 46 can be constructed using alternative materials and / or manufacturing methods. For example, the frame 46 or portions thereof can be constructed of polymer materials, ceramic materials, and / or various other materials. Additionally, the frame 46 can be manufactured via injection molding or alternative polymer manufacturing methods. Alternatively, if necessary, the frame 46 can be formed by a 3-D printing process. In addition, different parts of the frame 46 can be made of various materials and combined using alternative methods. Variations that combine different materials with different parts of the frame 46 can be conceivable.

[0148] For simplicity, when combined with the example implant 12, the frame 46 can be defined as having a first surface that turns away from the implant 12 when the implant 12 is attached to the frame 46 (e.g., a first surface that turns away from the target site in the body) and a second surface that faces the example implant 12 (e.g., a second surface that faces the target site in the body). In some cases, the attachment hole 70 can extend from the first surface to the second surface. In other words, in some cases, the attachment hole 70 can be defined as a hole and / or opening that extends from the first surface of the frame 46 that turns away from the implant 12 through the thickness of the frame 46 to the second surface of the frame 46 facing the implant 12.

[0149] The attachment holes 70 may be used to attach and / or couple the frame 46 to the example implant 12 . Figure 3A An example frame 46 is shown attached to an example implant 12. In addition, Figure 3 shows an example frame 46 attached to an example implant 12 at the distal or free end of each of four attachment arms 64. The free distal ends of the attachment arms 64 may be attached to the implant 12 by any desired attachment mechanism.

[0150] Figure 3B A detailed view of a portion of the proximal portion 54 of the frame 46 attached to the implant 12 is shown. Figure 3B An example attachment arm 64 is shown including a distal portion 68. Three attachment holes 70 are located along the distal portion 68 of the attachment arm 64. Additionally, Figure 3B An example attachment member (eg, wire) 76 is shown extending between and through one or more of the attachment apertures 70 located on the distal portion 68 of the attachment arm 64 .

[0151] The attachment member 76 can be one of several structures and / or techniques contemplated for attaching the example frame 46 to the example implant 12. Figure 3BAs shown, the attachment member 76 can be positioned, wrapped around, wrapped around and / or passed through one or more attachment holes 70 so that the attachment member 76 is prevented from being pulled away from the distal portion 68 of the attachment arm 64. In other words, wrapping the attachment member 76 through one or more of the attachment holes 70 can effectively attach the attachment member 76 to the attachment arm 64. In other words, it is contemplated that the attachment member 76 can be attached to the distal portion 68 of the attachment arm 64 (e.g., via the attachment holes 70) without directly attaching (e.g., welding, tying, etc.) either end of the attachment member 76 to any structure (e.g., the frame 46). In some cases, the attachment member 76 can be wrapped and / or wrapped around the attachment hole 70 one or more times to provide a friction fit and / or resist unraveling or loosening tension when a withdrawal force is applied to the attachment member 76. In other cases, the implant can be attached to the attachment arm 64 in another manner, such as with other attachment members attached to and / or extending from the attachment arm 64.

[0152] Although Figure 3B A single attachment member 76 is shown extending between two attachment apertures 70, but it is also contemplated that the attachment member 76 may extend and / or wrap between two or more of the attachment apertures 70. For example, it is contemplated that the attachment member 76 may be woven through three apertures 70 (e.g., up and down) in order to lock the attachment member 76 to the distal end 68 of the attachment arm 64.

[0153] The above discussion and the foregoing examples are not intended to limit the present invention to the use of attachment members (e.g., wires, lines, cables, etc.) to attach the frame 46 to the implant 12. Rather, various methods may be utilized to attach the frame 46 to the implant 12. For example, an adhesive may be used alone or in combination with another attachment mechanism to attach the frame 46 to the implant 12. Additionally, various injection molding techniques may be employed to attach the frame 46 to the implant 12. Furthermore, a combination of the disclosed techniques may be used to attach the frame 46 to the implant 12. For example, the attachment member 76 may be used in conjunction with an adhesive to attach the frame 46 to the implant 12 without having to wrap the attachment member 76 through the attachment hole 70.

[0154] As mentioned above, in the examples discussed herein, it is conceivable that the framework 46 may be able to "disassemble" from the implant 12. For example, the framework 46 may be configured to be disassembled from the implant 12 after the implant 12 is attached to the target site in the body. Therefore, it should be understood that in some examples disclosed herein, the framework member 46 can be temporarily attached to the implant 12. For example, the framework member 46 can be connected, attached or attached to the implant 12 when positioned in the delivery sheath 42, deployed from the delivery sheath 42 and manipulated to the appropriate position relative to the target site. Once positioned at the target site (for example, along the tendon and / or humeral head), the implant 12 can be attached to the target site via bioadhesive, tissue anchors and / or sutures. However, once the implant 12 is attached to the target site, the framework 46 can be pulled away from the implant 12 (for example, disassembled) and removed from the body. As will be described in more detail herein, in some cases, the implant 12 can be releasably coupled to the frame 46 via one or more tissue anchors that are also used to secure the implant 12 to tissue at the target site and are subsequently released from the frame 46 so as to remain at the target site with the implant at the conclusion of the medical procedure.

[0155] Figure 3B An example attachment configuration is shown that may allow the frame 46 to be detached from the implant 12 . Figure 3B The attachment member 76 is shown wound in a spiral pattern 80 along the surface of the implant 12 facing the target site. In other words, the attachment member 76 can form a spiral pattern 80 that remains in a plane that is substantially parallel to the plane of the surface of the implant 12 facing the target site. In addition, it should be understood that the attachment member 76 can extend from the side of the attachment arm 64 facing away from the implant 12, through the combined thickness of the attachment arm 64 and the implant 12, and ultimately exit the implant 12 on the surface of the implant 12 facing the target site. In addition, it should be understood that Figure 3B The spiral pattern 80 shown in FIG. 8 is one of various configurations that the attachment member 76 may be wrapped around in order to prevent the frame 46 from being released from the implant 12 prematurely.

[0156] The attachment member 76 can have a first end fixed to the free distal end of the attachment arm 64 positioned on a first side of the implant 12, and have a second end positioned on a second, opposite side of the implant 12. In some cases, the attachment member 76 can extend from the first side of the implant 12, through the implant 12 to the second side of the implant 12. However, in other cases, the attachment member 76 can extend from the first side of the implant 12 around the edge of the implant 12 to the second side of the implant 12.

[0157] In some cases, the attachment member 76 can be configured to detach from the implant 12 when a threshold level of force is applied. Figure 3B The spiral pattern 80 shown in FIG. 4 can provide the frame 46 with the ability to be detached from the implant 12 when a threshold "pull-off force" is applied to the frame 46. For example, after attaching the implant 12 to the target site, the clinician can apply a force to the frame 46 (e.g., via a tether) so that the frame 46 is pulled away from the implant 12. If the force is large enough (e.g., reaches a threshold force), the attachment member 76 (e.g., Figure 3B The spiral portion 80 of the attachment member 76 shown in FIG. 1 can be loosened and pulled back through the “body” (e.g., thickness) of the implant 12, thereby releasing the frame 46 from the implant 12. In other words, if a threshold pull-off force is applied to the frame 46, then Figure 3B The attachment member 76 shown in FIG. 1 , which forms a spiral 80 , can be loosened and pulled back through the implant 12 .

[0158] Figure 3C Another example method of attaching the frame 46 to the example implant 12 is shown. Figure 3C As shown, the attachment member 76 may include a spiral 81 (similar to the spiral 81) positioned on the surface of the implant 12 facing away from the target site. Figure 3B In addition, Figure 3C The attachment member 76 is shown to include a second spiral 82 positioned on a surface of the attachment arm 68 facing away from the implant 12. In other words, Figure 3C Two spirals 81 / 82 are shown, which are formed at opposite ends of the attachment member 76 and are positioned on the attachment arm 64 facing away from the implant 12 (eg, Figure 3C 82) and on one side of the implant 12 along the treatment site (e.g., Figure 3C The configuration of the helices 81 / 82 can provide the frame 46 with a "releasable" connection to the implant 12, similar to the configuration associated with Figure 3B discussed.

[0159] Figure 4 An example frame 46 is shown, which is coupled to the example implant 12 via the attachment member 76 as described above. In addition, Figure 4 The frame 46 is shown coupled to the example implant delivery system 40 in combination with the implant 12. Figure 2 Similar to the discussion, the implant delivery system 40 includes an implant delivery shaft 44 that extends through the example lumen 84 of the example delivery sheath 42 .

[0160] also, Figure 4 The delivery shaft 44 is shown coupled to the frame 46 via a connection assembly 88. The connection assembly 88 may include a first connection member 90 attached to the head 58 of the frame 46 and a second connection member 92 attached to the distal end 50 of the delivery shaft 44. Figure 4 The first connection member 90 directly attached to the second connection member 92 is not directly shown, but it should be understood that the first and second connection members 90 / 92 of the connection assembly 88 can form a mating connection. For example, in some cases, the first connection member 90 can form a male connection member, and the second connection member 92 can form a mating female connection member. In other words, in some examples, the second connection member 92 can include a cavity that is configured to extend on the first connection member 90 and allow the first connection member 90 to be inserted therein. In other cases, the first connection member 90 can be a female connection member, and the second connection member 92 can be a mating male connection member.

[0161] In addition, if Figure 4 As shown, it is contemplated that the second connecting member 92 can be disengaged or separated from the first connecting member 90. For example, in some cases, the connecting assembly 88 (including the first and second connecting members 90 / 92) can be defined as a "quick release" connecting assembly, or other separation connecting assembly. It is also contemplated that various design configurations can be used to engage / disengage the first and second connecting members 90 / 92 from each other (i.e., connect / disconnect). For example, the first and second connecting members 90 / 92 can be connected via threaded connections, friction fits, spring-loaded connections, bayonet connections, removable collars or other actuating mechanisms. In addition, the connecting members 90 / 92 can be engaged / disengaged by an operator of the device.

[0162] In some cases, the delivery shaft 44 can be attached (e.g., via a connection assembly 88) to the head 58 of the frame member 46. Figure 4 As shown, the first connection member 90 of the connection assembly 88 can be attached to the head 58 via the hole 60 (not shown). In some cases, the first connection member 90 can be attached to the head 58 of the frame member 46 via various mechanical fastening methods (e.g., injection molding, potting, bonding, etc.).

[0163] As discussed above, in some cases, a clinician can insert an implant delivery system 40 (including a delivery sheath 42, a delivery shaft 44, a frame 46, and an implant 12) through an incision and position the distal end of the implant delivery system 40 adjacent to a target implant site (e.g., a torn tendon). Once adjacent to the target site, the physician can manipulate the implant delivery shaft 44 to push the implant 12 (when attached to the removable frame 46) out of the delivery sheath 42 adjacent to the target implant site. For example, the physician can retract the delivery sheath 42 proximally relative to the delivery shaft 44 and the frame 46 and / or can advance the delivery shaft 44 and the frame 46 distally relative to the delivery sheath 42.

[0164] Figure 4The frame 46 and implant 12 are shown deployed from the distal portion 48 of the delivery sheath 42. In some cases, the frame 46 and implant 12 can have a generally concave shape relative to the delivery sheath 42. It should be appreciated that the concave shape of the frame member 46 and implant 12 can facilitate positioning the implant 12 along the generally circular shape of the humeral head of a person's shoulder.

[0165] However, when positioned in the delivery sheath 42 (e.g., prior to deployment), the frame 46 and implant 12 can be wrapped in a convex configuration around the delivery shaft 44. Thus, when pushed out of the sheath 42 (e.g., deployed), the frame 46 and implant 12 can transition from a first convex configuration (while tightly wrapped around the delivery shaft 44 within the lumen 84 of the delivery sheath 42) to a second concave configuration.

[0166] In other words, when positioned within the cavity 84 of the delivery sheath 42, the frame 46 and the implant 12 can be attached to the delivery shaft 44 via the connection assembly 88. In one example, when positioned within the delivery sheath 42, the frame 46 and the implant 12 can be wrapped or extended on the delivery shaft 44. The position of the frame 46 and the implant 12 can be in a convex form relative to the distal end 50 of the delivery shaft 44. When the frame 46 and the implant 12 are deployed out of the distal end 50 of the delivery shaft 44, the frame 46 and the implant 12 can "transform" from a convex form to a concave form (as observed relative to the distal end 50 of the delivery shaft 44). Additional details about the frame 46 and the implant delivery system 40 can be found in U.S. Patent No. 10,314,689, the entire contents of which are incorporated herein by reference.

[0167] Above-mentioned implant 12 and framework 46 may need delivery system 40 that implant 12 is positioned at desired position, then tendon anchor and bone anchor are deployed by independent delivery system, so that implant 12 is fixed to following tendon tissue and bone respectively.In some cases, can use anchor inserter to deliver a soft tissue anchor once, this needs user to reload each independent soft tissue anchor outside arthroscopic space.Therefore, anchor inserter can insert patient's shoulder (or other implant position) and remove up to eight times or more times or the same number of times as the soft tissue anchor existing therefrom.Bone anchor can be deployed in a manner similar to soft tissue anchor, wherein each time bone anchor deploys the punch that needs independent single use.It is conceivable that soft tissue anchor can be preassembled with implant and / or framework 46, to reduce the quantity of surgical steps and / or reduce the requirement of entrance / incision size.

[0168] Figure 5Another example framework member 100 is shown, which is configured to be releasably attached to the implant 12. The framework 100 can be configured to be delivered to a target location in the body in a manner similar to that described above with respect to the framework 46. For the convenience of discussion herein, the combined structure including the framework 100 and the implant 12 can be defined as having a proximal end 102 (i.e., lateral side end) and a distal end 104 (i.e., medial end). When the framework 100 and the implant 12 are initially positioned adjacent to the target site, the clinician can orient the framework 100 and the implant 12 (e.g., via a handle member attached to the proximal portion of the delivery shaft) so that the proximal portion 102 (i.e., lateral side end) can be adjacent to (e.g., covered) a portion of the humerus (e.g., on the bone), and the distal portion 104 (i.e., medial end) of the framework 100 and the implant 12 can cover the tendon.

[0169] Before deployment, the combination of detachable framework 100 and implant 12 can be included in (for example, accommodated in) the cavity of the delivery sheath, so that the distal opening of the delivery sheath is subsequently deployed to the distal side. The combination of detachable framework 100 and implant 12 can be self-wound and / or folded so that it can be positioned in the cavity of the delivery sheath. Alternatively, detachable framework 100 and implant 12 can be wound around the implant delivery shaft when being arranged in the delivery sheath and / or folded.

[0170] In some cases, the removable frame 100 can be formed as a monolithic structure by forming (e.g., machining, cutting, forming, stamping, laser cutting, etc.) a monolithic structure from a single piece of material. It is conceivable that the removable frame 100 can be constructed using alternative materials and / or manufacturing methods. For example, the frame 100 or a portion thereof can be constructed from a polymer material, a ceramic material, and / or various other materials. Additionally, the frame 100 can be manufactured via injection molding or an alternative polymer manufacturing method. Alternatively, if necessary, the frame 100 can be formed by a 3-D printing process. In addition, different parts of the frame 100 can be made of various materials and combined using alternative methods. Variations that combine different materials with different parts of the frame 100 can be conceivable.

[0171] For simplicity, when combined with the example implant 12, the frame 100 can be defined as having a first surface 106 facing away from the implant 12 when the implant 12 is attached to the frame 100 (e.g., a first surface facing away from the target site in the body) and a second surface 108 facing or juxtaposed with the example implant 12 (e.g., a second surface facing the target site in the body) (see, for example, Figure 6B). The frame 100 may include a plurality of attachment arms 110a, 110b, 110c, 110d, 110e, 110f (collectively referred to as 110) extending away from the body portion 112. Although the frame 100 is shown as including six attachment arms 110, it is contemplated that the frame 100 may also include less than six (e.g., one, two, three, four, or five) or more than six (e.g., seven, eight, or more) attachment arms 110 as desired. In some cases, the number of attachment arms 110 may be related to the number of tissue anchors used to secure the implant 12, as will be described in more detail herein. Soft tissue anchors 120a, 120b, 120c, 120d, 120e, 120f (collectively referred to as 120) may be positioned adjacent to the distal or free end of one or more of the attachment arms 110. In some embodiments, each attachment arm 110 may include a soft tissue anchor 120. However, this is not required. In some cases, not all of the attachment arms 110 include soft tissue anchors 120. For example, some of the attachment arms 110 may not have tissue anchors or other attachment mechanisms, or may include attachment mechanisms that are configured to remain with the frame 100, such as, but not limited to, those described in U.S. Pat. No. 10,314,689, the entire contents of which are incorporated herein by reference. In some cases, the attachment arms 110b, 110c, 110d, and 110e that cover soft tissue (e.g., tendons) each include a soft tissue anchor 120, while the attachment arms 110a and 110f that cover bones (e.g., humeral heads) each utilize an attachment mechanism that is configured to remain with the frame 100, as described above.

[0172] The soft tissue anchor 120 can be used to attach and / or couple the framework 100 to the example implant 12 during delivery of the implant 12 to the treatment site. In some cases, the soft tissue anchor 120 can also anchor the implant 12 to body tissue once positioned at the treatment site. For example, the soft tissue anchor 120 or a portion thereof can secure the implant 12 to soft tissue (e.g., a tendon) and remain in the body with the implant 12 after the framework 100 is removed from the treatment site. Figure 5 An example frame 100 is shown attached to an example implant 12. In addition, Figure 5 The example frame 100 is shown attached to the example implant 12 at the distal or free end of each of six attachment arms 110. The free distal ends of the attachment arms 110 may be attached to the implant 12 by any desired attachment mechanism.

[0173] Fig. 6A A detailed view of an illustrative soft tissue anchor 120a assembled with the frame 100 and implant 12 is shown. Figure 6B is Fig. 6A6B-6B of the cross-sectional view of an illustrative soft tissue anchor 120a and an attachment arm 110a. Although the soft tissue anchor 120a is described with respect to a particular attachment arm 110a, it should be understood that the soft tissue anchor 120a can be provided in any of the attachment arms 110 as desired. The soft tissue anchor 120a can include a proximal head 122, which is configured to press against the implant 12; and a distal fixation end 124, which is configured to penetrate the tissue. An elongated intermediate connecting portion or handle 126 can extend between the proximal head 122 and the distal fixation end 124. It is contemplated that the proximal head 122 can be a generally planar member having a width greater than the width of the intermediate connecting portion or handle 126. In some cases, the proximal head 122 can be generally disc-shaped, having a generally circular cross-sectional shape. However, this is not required. The proximal head 122 can have other cross-sectional shapes, such as, but not limited to, square, rectangular, elliptical, polygonal, and the like.

[0174] The distal fixation end 124 can be generally "V" shaped or pointed and can include a first barb 128a and a second barb 128b (collectively 128). The distal fixation end 124 can be shaped so that once the distal fixation end 124 is assembled with the frame 100 and / or body tissue, the proximal retraction of the soft tissue anchor 120a can be prevented or hindered. For example, the barbs 128 can each include a proximal end 130a, 130b (collectively 130) radially spaced from the intermediate connecting portion or handle 126 and a distal end 132a, 132b in contact with or coupled to the distal fixation end 124. In some cases, less than two or more than two barbs 128 can be provided. In some cases, the proximal ends 130 of the barbs 128 can be configured to deflect radially inwardly to advance the soft tissue anchor 120a distally through the frame 100, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Figure 6B), however, this is not required. The distal fixed end 124 or distal tip of the soft tissue anchor 120a is configured to guide the soft tissue anchor 120a when it is advanced into the body tissue. The barbs 128 are angled or inclined so that the soft tissue anchor 120a is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 120a to the proximal side is difficult or prevented. This can help ensure that once the soft tissue anchor 120a is assembled with the frame 100 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 128 can vary. It is conceivable that the barbs 128 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 128 can be used to help fix the soft tissue anchor 120a to the frame 100 and the implant 12 and / or in the tissue.

[0175] The intermediate connecting portion or handle 126 can be an elongated shaft having a generally cylindrical shape; however, the intermediate connecting portion or handle 126 can have other shapes as desired. Although the intermediate connecting portion or handle 126 is shown as having a generally uniform cross-sectional dimension, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 126 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 126 can decrease from the proximal head 122 toward the distal fixed end 124. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 120a can be formed as a single unitary structure or a series of components attached to each other as desired.

[0176] It is also contemplated that the soft tissue anchor 120a may be of other configurations. For example, the soft tissue anchor 120a may be a barbed "U" shaped tissue anchor similar to a staple, having two distally extending legs. In this case, the barbed edges or legs penetrate and secure within the tissue, while the connecting portion or bridge of the "U" provides support to press the implant 12 between the barbed legs. In other cases, the soft tissue anchor 120a may be a screw with a threaded shank. The threaded region may penetrate the tissue, while the head of the screw provides support to hold down the implant 12. These are just some examples.

[0177] The attachment arm 110a may include a recess 114a to accommodate the proximal head 122 therein. For example, the recess 114a may be a generally circular recess configured to receive the circular proximal head 122 of the soft tissue anchor 120. However, the recess 114a may take other shapes as desired. In some cases, the recess 114a may extend partially through the thickness 116a of the attachment arm 110a to define an area 118a of the attachment arm 110a having a reduced thickness. The recess 114a may be sized and shaped to receive the proximal head 122 of the soft tissue anchor 120a therein. The proximal head 122 of the soft tissue anchor 120a may be recessed or embedded in the recess 114a. For example, the recess 114a may be deep enough so that the proximal head 122 is flush with or below the first surface 106 (e.g., the surface facing away from the implant 12) of the frame 100. This may help reduce the delivery profile of the frame 100. However, this is not required. In some cases, the proximal head 122 of the soft tissue anchor 120a can extend above or beyond the first surface 106 of the frame 100.

[0178] In some cases, a through hole or aperture 140a can be formed through the region of reduced thickness 118a. The through hole 140a can be sized and shaped to receive the intermediate connecting portion 126 and allow the distal fixation end 124 to pass therethrough beyond the underside 108 of the frame 100. In some embodiments, the through hole 140a can be preformed in the attachment arm 110a. In other embodiments, the through hole 140a can be formed when the soft tissue anchor 120a is assembled with the attachment arm 110a. For example, the region of reduced thickness 118a can be configured to be pierced or broken when the distal fixation end 124 is pushed through the region of reduced thickness 118a. It is contemplated that the implant 12 can be positioned along the frame 100 such that when the soft tissue anchor 120a is assembled with the attachment arm 110a, the distal fixation end 124 pierces and penetrates the implant 12 such that the implant 12 is coupled to the frame 100, such as between the underside 108 of the frame and the barbed distal tip of the soft tissue anchor 120a, as shown. Figure 5 and FIG. 6A to FIG. 6B as shown in .

[0179] You can use something similar to the above Figures 2 to 4The delivery system and method described are delivered to the body by framework 100, implant 12 and soft tissue anchor 120a. Once implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws associated with the delivery framework 100 of the delivery device. The delivery shaft of the delivery device can be released from the framework 100 and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to the framework 100 and extend from the body so that once it is separated from the implant 12, the framework 100 can be retrieved. Then a tool can be advanced to separate the soft tissue anchor 120a from the framework 100. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 122 of the soft tissue anchor 120a. Then, force can be applied to the proximal head 122 by the tool to advance the soft tissue anchor 120a distally so that the distal fixed end 124 pierces the tissue to penetrate into the tissue. It is contemplated that the reduced thickness region 118a of the attachment arm 110a can be configured to be brittle so that when a force is applied to the proximal head 122 to pass the proximal head 122 through the through hole or hole 140a, the reduced thickness region 118a is detached from the attachment arm 110a. In some cases, the reduced thickness region 118a may be completely broken, so that the reduced thickness region 118a remains in the body with the soft tissue anchor 120a and the implant 12. In other cases, the reduced thickness region 118a can be configured to deform when the proximal head 122 passes through the through hole or hole 140a, so that the reduced thickness region 118a remains connected to the attachment arm 110a. The tool can be repositioned to align with another soft tissue anchor 120 that connects the implant 12 to the frame 100, and a force can be applied to the soft tissue anchor 120 with the tool to separate the additional soft tissue anchor 120 from the frame 100 and penetrate into the underlying body tissue (e.g., tendon). This can be repeated for each soft tissue anchor 120 provided with the frame 100. This can allow for deployment of multiple soft tissue anchors 120 without requiring the clinician to individually load each soft tissue anchor 120 into a tool and repeatedly insert and remove the tool from an incision into the treatment site.

[0180] Fig. 7A An exploded perspective view of an illustrative attachment arm 210 of a frame 200 and a soft tissue anchor 220 is shown. The frame 200 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 220 can be configured to be assembled with the frame 200 and the implant 12 to releasably secure the implant to the frame 200 during delivery of the implant 12 to the target site. Figure 7B is Fig. 7A 7B-7B of FIG. 7B is a cross-sectional view of an illustrative attachment arm 210 taken at line 7B-7B. Figure 7C2 is a top view of a soft tissue anchor 220 assembled with an illustrative attachment arm. Although the soft tissue anchor 220 is described with respect to a single attachment arm 210, it should be understood that the soft tissue anchor 220 can be provided in any number of attachment arms 210 as desired.

[0181] The soft tissue anchor 220 may include a proximal head 222 configured to press against the implant 12; and a distal fixed end 224 configured to penetrate the tissue. An elongated intermediate connecting portion or handle 226 may extend between the proximal head 222 and the distal fixed end 224. It is contemplated that the proximal head 222 may be a generally planar component having a width greater than the width of the intermediate connecting portion or handle 226. In some cases, the proximal head 222 may be generally disc-shaped having a generally circular cross-sectional shape. However, this is not required. The proximal head 222 may have other cross-sectional shapes, such as but not limited to square, rectangular, elliptical, polygonal, etc. The proximal head 222 may include one or more radially extending lugs 234a, 234b (collectively referred to as 234) extending from its outer periphery, such that the lugs 234 define an area of ​​the proximal head 222, whose cross-sectional dimension 238 is greater than the cross-sectional dimension 236 of the proximal head without the lugs 234. The lugs 234 can be sized and shaped to mate with corresponding slots and / or grooves in the attachment arm 210, as will be described in greater detail herein. In some cases, one or more lugs 234 can be arranged helically around the proximal head 222 like a male thread.

[0182] The distal fixation end 224 can be generally "V" shaped or pointed and can include a first barb 228a and a second barb 228b (collectively 228). The distal fixation end 224 can be shaped so that once the distal fixation end 224 is assembled with the frame 200 and / or body tissue, the proximal retraction of the soft tissue anchor 220 can be prevented or hindered. For example, the barbs 228 can each include a proximal end 230a, 230b (collectively 230) radially spaced from the intermediate connecting portion or handle 226 and a distal end 232a, 232b (collectively 232) in contact with or coupled to the distal fixation end 224. In some cases, less than two or more than two barbs 228 can be provided. In some cases, the proximal ends 230 of the barbs 228 can be configured to deflect radially inwardly to advance the soft tissue anchor 220 distally through the frame 200, the implant 12, and / or body tissue, and to resume an expanded, outwardly extended configuration (e.g., Fig. 7A), however, this is not required. The distal fixed end 224 or distal tip of the soft tissue anchor 220 is configured to guide the soft tissue anchor 220 when it is advanced into the body tissue. The barbs 228 are angled or inclined so that the soft tissue anchor 220 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 220 to the proximal side is difficult or prevented. This can help ensure that once the soft tissue anchor 220 is assembled with the frame 200 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 228 can vary. It is conceivable that the barbs 228 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 228 can be used to help fix the soft tissue anchor 220 to the frame 200 and the implant 12 and / or in the tissue.

[0183] The intermediate connecting portion or handle 226 can be an elongated rod having a generally cylindrical shape; however, the intermediate connecting portion or handle 226 can have other shapes as desired. Although the intermediate connecting portion or handle 226 is shown as having a generally uniform cross-sectional dimension, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 226 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 226 can decrease from the proximal head 222 toward the distal fixed end 224. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 220 can be formed as a single unitary structure or a series of components attached to each other as desired.

[0184] It is also contemplated that the soft tissue anchor 220 may be in other configurations. For example, the soft tissue anchor 220 may be a screw having a threaded distal region. The threaded region may penetrate the tissue, while the head of the screw provides support to hold down the implant. This is just one example.

[0185] The attachment arm 210 may include a generally circular hole 214 configured to receive a proximal head 222 of a soft tissue anchor 220. The hole 214 may extend through the thickness of the attachment arm 210 from a first surface facing away from the implant 12 when the implant 12 is attached to the frame 200 (e.g., a first surface facing away from a target site in the body) and a second surface 208 facing or juxtaposed with the example implant 12 (e.g., a second surface facing a target site in the body). The hole 214 may be sized and shaped to receive the proximal head 222 of the soft tissue anchor 220 therein. The hole 214 may include a circumferential groove 216 extending around its periphery and positioned between the first surface 206 and the second surface 208. The diameter of the groove 216 may be greater than the diameter of the hole 214. It is also contemplated that the diameter of the groove 216 may be at least as large as the major cross-sectional dimension 238 of the proximal head 222 of the soft tissue anchor 220. As will be described in more detail, this can allow the lug 234 of the proximal head 222 to be rotatably disposed within the recess 216. In some cases, the aperture 214 can also include a first axially extending slot 218a and / or a second axially extending slot 218b (see, e.g., Figure 7C ) (collectively referred to as 218). The slot 218 may extend from the circumferential groove 216 to the second surface 208, such as Figure 7B As shown. The width of the slot 218 can be greater than the width of the lug 234 to allow the lug 234 to slide therein. It is contemplated that the depth of the slot 218 can be similar to the depth of the groove 216, however this is not required. In other words, the slot 218 can extend to the same radial position as the circumferential groove 216. For example, the slot 218 can be positioned on diametrically opposite sides of the hole 214 (i.e., circumferentially spaced 180 degrees apart). In other cases, the circumferential groove 216 can be a spiral groove extending to the second surface 208 of the frame 200.

[0186] To assemble the soft tissue anchor 220 with the attachment arm 210, the lug 234 of the proximal head 222 can be aligned with the axially extending slot 218 adjacent the second surface 208 of the attachment arm 210. The lug 234 can then be advanced within the slot 218 toward the circumferential groove 216 until the upper edge of the circumferential groove 216 blocks further movement of the lug 234. The soft tissue anchor 220 can then be rotated such that the lug 234 is displaced circumferentially from the slot 218, as shown in FIG. Figure 7CAs shown. Once the lug 234 is circumferentially displaced from the slot 218, axial movement of the soft tissue anchor 220 (e.g., movement between the first and second surfaces 206, 208) can be prevented. In the case where the circumferential groove 216 is a spiral groove, the lug 234 can enter the circumferential groove 216 at the second surface 208 and rotate therein to position the lug 234 in the circumferential groove 216. After the soft tissue anchor 220 is assembled with the frame 200, the implant 12 can be attached adjacent to the second surface 208 of the frame 200. It is contemplated that the soft tissue anchor 220 can penetrate or pierce the implant 12 (similar to Figure 6B ) to secure the implant 12 to the frame 200.

[0187] You can use something similar to the above Figures 2 to 4The delivery system and method described delivers the framework 200, implant 12 and soft tissue anchor 220 to the body. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow the insertion of other devices. In some cases, a tether can be connected to the framework 200 and extend from the body so that the framework 200 can be retrieved once it is separated from the implant 12. The tool can then be advanced to separate the soft tissue anchor 220 from the framework 100. In some cases, the tool can be similar to a screwdriver-type tool, but this is not necessary. In some cases, the tool can include a protrusion or recess, which is configured to engage the lug 234, so as to rotate the soft tissue anchor 220. In other embodiments, the tool can be configured to engage features in the proximal head 222, such as, but not limited to, grooves, recesses, angled sides, etc. The tool can be aligned and engaged with the proximal head 222 of the soft tissue anchor 220. A rotational force may then be applied to the tool to rotate the soft tissue anchor 220 until the lug 234 is aligned with the slot 218. In some cases, an axial force may be applied while rotating the soft tissue anchor 220 so that the soft tissue anchor 220 is axially displaced within the hole 214 when the lug 234 is aligned with the slot 218. If an axial force is not applied during rotation, once the lug 234 is aligned with the slot 218, an axial force may be applied to the soft tissue anchor 220 to urge the lug 234 along the slot 218 toward the second surface 208. The soft tissue anchor 220 may be axially displaced until the proximal head 222 exits the hole 214 and the distal fixation end 224 penetrates body tissue. In some cases, after the soft tissue anchor 220 is rotated by the tool to align the lug 234 with the slot 218, the tool can then be used as a punch or driver to apply an axial force to the soft tissue anchor 220, such as by striking with a mallet to drive the soft tissue anchor 220 into the tissue. In the case where the circumferential groove 216 is a spiral groove, the rotation of the soft tissue anchor 220 by the tool can screw the soft tissue anchor 220 into the tissue. The tool can be repositioned to align with another soft tissue anchor 220, and the above steps are repeated to separate the additional soft tissue anchor 220 from the frame 200. This can be repeated for each soft tissue anchor 220. This can allow multiple soft tissue anchors 220 to be deployed without the clinician having to load each soft tissue anchor 220 individually into the tool and repeatedly insert and remove the tool.

[0188] Fig. 8A A perspective view of another illustrative attachment arm 310 of a frame 300 and a soft tissue anchor 320 is shown. Figure 8B yes Fig. 8A1 and 12. An exploded perspective view of an illustrative attachment arm 310 of a frame 300 and a soft tissue anchor 320. The frame 300 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 320 can be configured to be assembled with the frame 300 and the implant 12 to releasably secure the implant to the frame 300. Figure 8C is Fig. 8A 8C-8C of a cross-sectional view of an illustrative attachment arm 310. Although the soft tissue anchor 320 is described with respect to a single attachment arm 310, it should be understood that the soft tissue anchor 320 can be provided in any number of attachment arms 310 as desired.

[0189] exist FIG. 8A to FIG. 8C In the illustrative embodiment of the present invention, the soft tissue anchor 320 can be removably coupled to the attachment arm 310 via a retainer 340. The retainer 340 can be configured to slide over the free end of the attachment arm 310. Generally, the soft tissue anchor 320 can be advanced through the hole 342 in the retainer and the hole 314 in the attachment arm 310. The retainer 340 can include a feature that is configured to engage a mating feature of the soft tissue anchor 320 to releasably secure the soft tissue anchor 320 to the feature.

[0190] The soft tissue anchor 320 may include a proximal head 322 configured to press against the implant 12; and a distal fixed end 324 configured to penetrate the tissue. An elongated intermediate connecting portion or handle 326 may extend between the proximal head 322 and the distal fixed end 324. It is contemplated that the proximal head 322 may be a generally planar component having a width greater than the width of the intermediate connecting portion or handle 326. In some cases, the proximal head 322 may be generally disc-shaped having a generally circular cross-sectional shape. However, this is not required. The proximal head 322 may have other cross-sectional shapes, such as, but not limited to, square, rectangular, elliptical, polygonal, and the like. The proximal head 322 may include a radially extending edge or stop 334 extending from a side surface of the proximal head 322. In some cases, the edge or stop 334 may extend around the entire circumference of the proximal head 322. In other embodiments, the detents 334 can include a plurality of detents (e.g., two, three, four, or more) spaced about the circumference of the proximal head 322. When more than one detent 334 is provided, the detents 334 can be evenly spaced or eccentrically spaced protrusions, as desired. The detents 334 can be sized and shaped to mate with corresponding slots and / or recesses in the retainer 340, as will be described in greater detail herein.

[0191] The distal fixation end 324 can be generally "V" shaped or pointed and can include a first barb 328a and a second barb 328b (collectively 328). The distal fixation end 324 can be shaped so that once the distal fixation end 324 is assembled with the frame 300 and / or body tissue, the proximal retraction of the soft tissue anchor 320 can be prevented or hindered. For example, the barbs 328 can each include a proximal end 330a, 330b (collectively 330) radially spaced from the intermediate connecting portion 326 and a distal end 332a, 332b (collectively 332) in contact with or coupled to the distal fixation end 324. In some cases, less than two or more than two barbs 328 can be provided. In some cases, the proximal ends 330 of the barbs 328 can be configured to deflect radially inwardly to advance the soft tissue anchor 320 distally through the frame 300, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Figure 8B and Figure 8C ), however, this is not required. The distal fixed end 324 or distal tip of the soft tissue anchor 320 is configured to guide the soft tissue anchor 320 when it is advanced into the body tissue. The barbs 328 are angled or inclined so that the soft tissue anchor 320 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 320 to the proximal side is difficult or blocked. This can help ensure that once the soft tissue anchor 320 is assembled with the framework 300 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 328 can vary. It is conceivable that the barbs 328 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 328 can be used to help fix the soft tissue anchor 320 to the framework 300 and the implant 12 and / or in the tissue.

[0192] The intermediate connecting portion or handle 326 can be an elongated rod having a generally cylindrical shape; however, the intermediate connecting portion or handle 326 can have other shapes as desired. Although the intermediate connecting portion or handle 326 is shown as having a generally uniform cross-sectional dimension, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 326 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 326 can decrease from the proximal head 322 toward the distal fixed end 324. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 320 can be formed as a single unitary structure or a series of components attached to each other as desired.

[0193] It is also contemplated that the soft tissue anchor 320 may be of other configurations. For example, the soft tissue anchor 320 may be a barbed "U" shaped tissue anchor similar to a staple, having two distally extending legs. In this case, the barbed edges or legs penetrate and secure within the tissue, while the connecting portion or bridge of the "U" provides support to press the implant 12 between the barbed legs. In other embodiments, the soft tissue anchor 320 may be a screw having a threaded distal region. The threaded region may penetrate the tissue, while the head of the screw provides support to hold the implant down. This is just one example.

[0194] The attachment arm 310 may include a generally circular hole 314 configured to receive a portion of the soft tissue anchor 320. However, the hole 314 may take other shapes as desired. The hole 314 may have a cross-sectional shape similar to the cross-sectional shape of the proximal head 322 of the soft tissue anchor 320 and extend through the thickness of the attachment arm 310 from a first surface 306 facing away from the implant 12 when the implant 12 is attached to the frame 300 (e.g., a first surface facing away from the target site in the body) and a second surface 308 facing the example implant 12 or juxtaposed therewith (e.g., a second surface facing the target site in the body). The hole 314 may be sized and shaped to allow the proximal head 322 of the soft tissue anchor 320 to pass therethrough. For example, the hole 314 may have a diameter 316 that is larger than the diameter 336 of the proximal head 322 and larger than the maximum diameter 338 of the proximal head 322 (e.g., at the stop 334).

[0195] The retainer 340 may include a top side 344 facing away from the implant 12 when the implant 12 is attached to the frame 300, a bottom side 346 facing the implant 12 when the implant 12 is attached to the frame 300, a first lateral side 348 extending between the top side 344 and the bottom side 346, and a second lateral side 350 opposite the first lateral side and extending between the top side 344 and the bottom side 346. The top side 344, the bottom side 346, the first lateral side 348, and the second lateral side 350 can collectively define a channel 352 extending from a first end 354 to a second end 356 of the retainer 340. The channel 352 can be sized and shaped to allow the retainer 340 to slide on the attachment arm 310 (e.g., Fig. 8A344 ), while preventing the retainer 340 from accidentally disengaging from the attachment arm 310 before being assembled with the soft tissue anchor 320. The retainer 340 may also include a first opening 358 in the top side 344 and a second opening 360 defined in the bottom side 346. The first and second openings 358, 360 may be generally circular; however, the first and second openings 358, 360 may take other shapes as desired. The first and second openings 358, 360 may be generally aligned to define a hole 342 extending from the top side 344 to the bottom side 346. The first and second openings 358, 360 may have similar or identical diameters as desired, or may have different diameters. In some embodiments, the diameter of the first opening 358 may be similar or identical to the diameter 336 of the proximal head 322 of the soft tissue anchor 320, while the diameter of the second opening 360 may be greater than the maximum diameter 338 of the proximal head 322 at the stop 334.

[0196] To assemble the soft tissue anchor 320 with the attachment arm 310, the retainer 340 can be advanced over the free end of the attachment arm 310 until the aperture 342 of the retainer 340 is substantially aligned with the aperture 314 of the attachment arm 310. The distal fixed end 324 of the soft tissue anchor 320 can then be advanced through the apertures 314, 342 in a direction from the top side 344 toward the bottom side 346 or from the bottom side 346 toward the top side 344 of the retainer 340, as desired. The soft tissue anchor 320 can be advanced until the detent 334 on the proximal head region 322 engages a mating recess 362 formed in the side wall of the first opening 358 (see, e.g., Figure 8C ), a first opening 358 is formed in the top side 344 of the retainer 340. The detent 334 and the corresponding recess 362 can form a snap fit or other mechanical engagement to maintain the soft tissue anchor 320 in a desired configuration during delivery of the implant 12. It is contemplated that during assembly, the implant 12 can be positioned adjacent the second surface 308 of the frame 300 and / or the bottom side 346 of the retainer 340 such that the soft tissue anchor 320 pierces the implant 12 and secures it to the frame 300.

[0197] You can use something similar to the above Figures 2 to 4The delivery system and method described are delivered to the body by the framework 300, the implant 12 and the soft tissue anchor 320. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow the insertion of other devices. In some cases, a tether can be connected to the framework 300 and extend from the body so that the framework 300 can be retrieved once it is separated from the implant 12. Then a tool can be advanced to separate the soft tissue anchor 320 from the framework 300. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 322 of the soft tissue anchor 320. Then, a force can be applied, such as with a mallet, to advance the soft tissue anchor 320 distally so that the distal fixed end 324 or the distal top pierces the tissue. It is contemplated that when force is applied to the proximal head 322, the top side 344 of the retainer 340 may flex, deflect, deform, or break, thereby allowing the detent 334 to be released from the mating recess 362. As described above, the second opening 360 may be sized so that the maximum diameter 338 of the proximal head 322 easily passes therethrough, however this is not required. The tool may be repositioned to align with another soft tissue anchor 220, and force applied to the soft tissue anchor 320 to separate it from the frame 300. This may be repeated for each soft tissue anchor 320. This may allow for the deployment of multiple soft tissue anchors 320 without requiring the clinician to individually load each soft tissue anchor 320 into the tool and repeatedly insert and remove the tool.

[0198] Fig.8D A cross-sectional view of an alternative retainer 370 assembled with attachment arms 310 and soft tissue anchors 320' is shown. For clarity, the implant is not shown. However, it should be understood that the implant 12 may be similar to the Figure 8C 310 , soft tissue anchor 320 ′ and retainer 370 are assembled together in the manner shown in . Fig. 8E is a perspective view of an illustrative retainer 370 after a soft tissue anchor 320' is deployed from the retainer 370. The soft tissue anchor 320' may be similar in form and function to the FIG. 8A to FIG. 8C 386 of the retainer 370 to facilitate advancement of the head 322 of the soft tissue anchor 320' through the first opening 386.

[0199] The retainer 370 may include a top side 372 facing away from the implant 12 when the implant 12 is attached to the frame 300, a bottom side 374 facing the implant 12 when the implant 12 is attached to the frame 300, a first lateral side 376 extending between the top side 372 and the bottom side 374, and a second lateral side 378 opposite the first lateral side and extending between the top side 372 and the bottom side 374. The top side 372, the bottom side 374, the first lateral side 376, and the second lateral side 378 may collectively define a channel 380 extending from a first end 382 to a second end 384 of the retainer 370. The channel 380 may be sized and shaped to allow the retainer 370 to slide on the attachment arm 310 while preventing the retainer 370 from accidentally becoming detached from the attachment arm 310 prior to assembly with the soft tissue anchor 320'. The retainer 370 can also include a first opening 386 in the top side 372 and a second opening 388 defined in the bottom side 374. The first and second openings 386, 388 can be generally circular; however, the first and second openings 386, 388 can have other shapes as desired. The first and second openings 386, 388 can be generally aligned to define a hole 390 extending from the top side 372 to the bottom side 374. The first and second openings 386, 388 can have similar or identical diameters 392, however, this is not required. It is contemplated that the first and second openings 386, 388 can have different diameters as desired. The diameter 392 of the openings 386, 388 can be smaller than the diameter 336 of the proximal head 323 of the soft tissue anchor 320' so that when the soft tissue anchor 320' is assembled with the retainer 370 and the attachment arm 310, the proximal head 322 is located at the top of the top side 372, as shown in FIG. Fig.8D The diameter 316 of the hole 314 of the attachment arm 310 may be larger than the diameter 336 of the proximal head 322 (and the diameter 392 of the openings 386, 388) so that the proximal head 322 of the soft tissue anchor 320' passes freely through the hole 314 when deployed.

[0200] To assemble the soft tissue anchor 320' with the attachment arm 310, the retainer 370 can be advanced over the free end of the attachment arm 310 until the hole 390 of the retainer 370 is generally aligned with the hole 314 of the attachment arm 310. The distal fixation end 324 of the soft tissue anchor 320' is then advanced through the holes 314, 390 in a direction from the top side 372 toward the bottom side 374 of the retainer 370. The soft tissue anchor 320' can be advanced until the bottom surface of the proximal head region 322 engages the top side 372 of the retainer 370. It is contemplated that the distal fixation end 324 or distal tip of the soft tissue anchor 320' can pierce the implant to secure the soft tissue anchor 320' to the frame 300. For example, the structure of the distal fixation end 324 of the soft tissue anchor 320' can prevent the anchor 320' from retracting once it has pierced the implant. It is contemplated that during assembly, the implant 12 may be positioned adjacent the second surface 308 of the frame 300 and / or the bottom side 374 of the retainer 370 such that the soft tissue anchor 320' pierces the implant 12 and secures it to the frame 300 during delivery of the implant 12 to the target site.

[0201] You can use something similar to the above Figures 2 to 4The delivery system and method described delivers the framework 300, implant and soft tissue anchor 320' to the body. Once the implant is positioned at the target location, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow the insertion of other devices. In some cases, a tether can be connected to the framework 300 and extend from the body so that the framework 300 can be retrieved once it is separated from the implant 12. Then a tool can be advanced to separate the soft tissue anchor 320' from the framework 300. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 322 of the soft tissue anchor 320'. Then, a force can be applied to advance the soft tissue anchor 320' distally so that the distal fixed end 324 or the distal top pierces the tissue. It is conceivable that when a force is applied to the proximal head 322, the top side 372 of the retainer 370 can be flexed, deflected, deformed or broken, thereby allowing the proximal head 322 to pass through the hole 390. In some cases, a weak area can be formed in the retainer 370 so that the retainer 370 breaks at the predetermined position 394. However, this is not required. It is also conceivable that the retainer 370 can be flexible so as to allow the proximal head 322 to pass through without causing mechanical damage to the retainer 370. In some cases, the second opening 388 can be sized so that the proximal head 322 can easily pass through it, however, this is not required. The tool can be repositioned to align with another soft tissue anchor 320', and a force is applied to the soft tissue anchor 320' to separate it from the frame 300. This can be repeated for each soft tissue anchor 320'. This can allow multiple soft tissue anchors 320' to be deployed without the clinician having to load each soft tissue anchor 320' individually into the tool and repeatedly insert and remove the tool.

[0202] Fig.9A An exploded perspective view of another illustrative attachment arm 410 of the frame 400 and soft tissue anchor 420 is shown. Fig. 9B 4 is a perspective view of an illustrative attachment arm 410 of a frame 400 assembled with a soft tissue anchor 420. The frame 400 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 420 can be configured to be assembled with the frame 400 and an implant 12 (not explicitly shown) to releasably secure the implant to the frame 400. Although the soft tissue anchor 420 is described with respect to a single attachment arm 410, it should be understood that the soft tissue anchor 420 can be provided in any number of attachment arms 410 as desired.

[0203] The soft tissue anchor 420 may include a proximal head 422 configured to press against the implant 12 and a distal fixed end 424 configured to penetrate tissue. An elongated intermediate connecting portion or handle 426 may extend between the proximal head 422 and the distal fixed end 424. It is contemplated that the proximal head 422 may be a generally planar component having a width greater than the width of the intermediate connecting portion 426. In some cases, the proximal head 422 may be generally disc-shaped having a generally circular cross-sectional shape. However, this is not required. The proximal head 422 may have other cross-sectional shapes, such as, but not limited to, square, rectangular, elliptical, polygonal, and the like.

[0204] The distal fixation end 424 can be generally "V" shaped or pointed and can include a first barb 428a and a second barb 428b (collectively 428). The distal fixation end 424 can be shaped so that once the distal fixation end 424 is assembled with the frame 400 and / or body tissue, the proximal retraction of the soft tissue anchor 420 can be prevented or hindered. For example, the barbs 428 can each include a proximal end 430a, 430b (collectively 430) radially spaced from the intermediate connecting portion or handle 426 and a distal end 432a, 432b (collectively 432) in contact with or coupled to the distal fixation end 424. In some cases, less than two or more than two barbs 428 can be provided. In some cases, the proximal ends 430 of the barbs 428 can be configured to deflect radially inwardly to advance the soft tissue anchor 420 distally through the frame 400, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Fig.9A ), however, this is not necessary. The distal fixed end 424 or distal tip of the soft tissue anchor 420 is configured to guide the soft tissue anchor 420 when it is advanced into the body tissue. The barbs 428 are angled or inclined so that the soft tissue anchor 420 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 420 to the proximal side is difficult or blocked. This can help ensure that once the soft tissue anchor 420 is assembled with the framework 400 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 428 can vary. It is conceivable that the barbs 428 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 428 can be used to help fix the soft tissue anchor 420 to the framework 400 and the implant 12 and / or in the tissue.

[0205] The intermediate connecting portion or handle 426 can be an elongated rod having a generally cylindrical shape; however, the intermediate connecting portion or handle 426 can take other shapes as desired. Although the intermediate connecting portion or handle 426 is shown as having a cross-sectional dimension of a generally uniform diameter 434, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 426 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 426 can decrease from the proximal head 422 toward the distal fixed end 424. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 420 can be formed as a single unitary structure or a series of components attached to each other as desired.

[0206] It is also contemplated that the soft tissue anchor 420 may be in other configurations. For example, the soft tissue anchor 420 may be a barbed "U" shaped tissue anchor similar to a staple, having two distally extending legs. In this case, the barbed edges or legs penetrate and secure within the tissue, while the connecting portion or bridge of the "U" provides support to press the implant 12 between the barbed legs. In other embodiments, the soft tissue anchor 420 may be a screw with a threaded distal region. The threaded region may penetrate the tissue, while the head of the screw provides support to hold the implant down. This is just one example.

[0207] The attachment arm 410 can include a first flexible arm 412a and a second flexible arm 412b (collectively 412) adjacent its free end. It is contemplated that the flexible arm 412 can be formed by removing some material from the attachment arm 410, or otherwise shaping the attachment arm 410 to include the first and second flexible arms 412a / 412b with a slot or opening therebetween, although other techniques can be used as desired. The width of the flexible arm 412 can increase toward the free end to define a distal opening 414 having a first width 418 and an aperture 416 having a second width 440. The width 418 of the distal opening 414 can be less than the width 440 of the aperture 416 spaced proximally from the distal opening 414. The distal opening 414 and the hole 416 can extend through the thickness of the attachment arm 410 from a first surface facing away from the implant 12 when the implant 12 is attached to the frame 400 (e.g., a first surface facing away from a target site in the body) and a second surface 408 facing the example implant 12 (e.g., a second surface facing a target site in the body). The hole 416 can be sized and shaped to prevent the proximal head 422 of the soft tissue anchor 420 from passing therethrough. For example, the width 440 of the hole 416 can be sufficient to accommodate the intermediate connecting portion or handle 426, but still be less than the width or diameter 436 of the proximal head 422. The width of the opening 414 can be less than the width or diameter 436 of the proximal head 422 and the width or diameter of the intermediate connecting portion or handle 426.

[0208] The flexible arms 412 can be configured to temporarily flex away from (or substantially orthogonal to) the longitudinal axis 444 of the attachment arm 410, as shown at arrows 442a, 442b (collectively 442). It is contemplated that the flexible arms 412 can be configured to flex in the directions shown at arrows 442 (i.e., flex away from each other) to temporarily widen the distal opening 414 in response to an applied force and return to an original, unbiased configuration in the absence of an applied force. In some cases, the intermediate connecting portion or handle 426 of the soft tissue anchor 420 can have a diameter 434 that is greater than the width 418 of the distal opening 414. To assemble the soft tissue anchor 420 with the attachment arm 410, the intermediate portion or handle 426 can be pushed through the distal opening 414 in a lateral direction parallel to the longitudinal axis 444 of the attachment arm 410. The intermediate portion or handle 426 can bias the flexible arms 412 outwardly 442 to allow the intermediate portion 426 to pass through the distal opening 414 and into the hole 416. Once the intermediate portion or handle 426 passes through the distal opening 414, the flexible arms 412 can return to or toward their original unbiased configuration (i.e., the flexible arms 412 can move toward each other). In the absence of an applied force, the intermediate portion or handle 426 remains within the hole 416, with the head 422 located on the top surface 406 of the attachment arm 410 and the distal fixed end 424 located below the lower surface 408 of the attachment arm 410. The diameter 440 of the hole 416 can be greater than the diameter 434 of the intermediate portion or handle 426, so that the intermediate portion 426 is free to move within the hole 416. In other embodiments, the diameter 440 of the hole 416 can be substantially the same as the diameter 434 of the middle portion or handle 426 to form a friction fit between the middle portion or handle 426 and the attachment arm 410. Alternatively, the soft tissue anchor 420 can be assembled with the attachment arm 410 by axially advancing the distal fixation end 424 through the hole 416 in a direction from the first surface 406 to the second surface 408. It is contemplated that the barb 428 can be deflected toward the middle portion 426 to allow the distal fixation end 424 to pass through the hole 416. Simultaneously with or after the soft tissue anchor 420 is assembled with the frame 400, the implant 12 can be attached adjacent to the second surface 408 of the frame 400. It is contemplated that the soft tissue anchor 420 can penetrate or pierce the implant 12 (similar to Figure 6B ) to secure the implant 12 to the frame 400 for delivery to the target site.

[0209] You can use something similar to the above Figures 2 to 4The delivery system and method described delivers the framework 400, implant 12 and soft tissue anchor 420 to the body. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to the framework 400 and extend from the body so that once it is separated from the implant 12, the framework 400 can be retrieved. Then a tool can be advanced to separate the soft tissue anchor 420 from the framework 400. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 422 of the soft tissue anchor 420. Then, a force can be applied to advance the soft tissue anchor 420 distally so that the distal fixed end 424 or the distal top pierces the tissue. The tool can be repositioned to align with another soft tissue anchor 420, and a force is applied to the soft tissue anchor 420 to separate it from the framework 400. This can be repeated for each soft tissue anchor 420. This can allow for deployment of multiple soft tissue anchors 420 without requiring the clinician to individually load each soft tissue anchor 420 into the tool and repeatedly insert and remove the tool. Once each soft tissue anchor 420 is driven into the tissue, the frame 400 can be retracted from the body. The retraction of the frame 400 can apply a lateral pulling force to the attachment arms 410, which in turn can bias the flexible arms 412 outwardly 442, thereby allowing the attachment arms 410 to pass over the middle portion or handle 426 of the soft tissue anchor 420, thereby releasing the frame 400 from the soft tissue anchor 420.

[0210] Fig. 9C Shows that Fig.9A and Fig. 9B 4. A cross-sectional view of an alternative soft tissue anchor 420' for use with the attachment arm 410 of FIG. The soft tissue anchor 420' may be similar in form and function to the FIG. 9A to FIG. 9B 408. The soft tissue anchor 420' is similar to the soft tissue anchor 320 described above, and like elements are labeled with like numbers. The soft tissue anchor 420' can also include a circumferentially extending recess 450 formed in the proximal head 422. The recess 450 can have a height 452 similar to the thickness of the attachment arm 410 (e.g., the distance from the first surface 406 to the second surface 408). It is also contemplated that the cross-section or diameter 454 of the proximal head 422 at the recess 450 can be similar to, equal to, or greater than the diameter 440 of the hole 416 in the attachment arm 410.

[0211] To assemble the soft tissue anchor 420' with the attachment arm 410, the proximal head 422 can be pushed through the distal opening 414 in a lateral direction parallel to the longitudinal axis 444 of the attachment arm 410, with the recess 450 aligned with the attachment arm 410. The proximal head 422 can bias the flexible arm 412 outward (e.g., Fig.9A 416). As shown in the figure, the proximal head 422 is moved through the distal opening 414 and into the hole 416 to allow the proximal head 422 to pass through the distal opening 414 and into the hole 416. Once the proximal head 422 passes through the distal opening 414, the flexible arm 412 returns to its original unbiased configuration or moves back toward it or laterally inward to apply a clamping force or squeezing force to the proximal head 422. The recess 450 of the proximal head 422 can be positioned so that a portion of the flexible arm 412 is disposed within the recess 450. In the absence of an applied force, the proximal head 422 remains within the hole 416. While or after the soft tissue anchor 420' is assembled with the frame 400, the implant 12 can be attached adjacent to the second surface 408 of the frame 400. It is contemplated that the soft tissue anchor 420' can penetrate or pierce the implant 12 (similar to Figure 6B ) to secure the implant 12 to the frame 400.

[0212] You can use something similar to the above Figures 2 to 4 The delivery system and method described delivers the framework 400, implant 12 and soft tissue anchor 420' to the body. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to the framework 400 and extend from the body so that once it is separated from the implant 12, the framework 400 can be retrieved. Then a tool can be advanced to separate the soft tissue anchor 420' from the framework 400. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 422 of the soft tissue anchor 420'. Then, a force can be applied to advance the soft tissue anchor 420' distally so that the distal fixed end 424 or the distal top pierces the tissue. The tool can be repositioned to align with another soft tissue anchor 420', and a force is applied to the soft tissue anchor 420' to separate it from the framework 400. This can be repeated for each soft tissue anchor 420'. This can allow for the deployment of multiple soft tissue anchors 420' without requiring the clinician to individually load each soft tissue anchor 420' into the tool and repeatedly insert and remove the tool. Once each soft tissue anchor 420' is driven into the tissue, the frame 400 can be retracted from the body. The retraction of the frame 400 can apply a lateral pulling force to the attachment arms 410, which in turn can bias the flexible arms 412 outwardly 442, thereby allowing the attachment arms 410 to pass over the proximal heads 422 of the soft tissue anchors 420', thereby releasing the frame 400 from the soft tissue anchors 420'.

[0213] Fig. 10A An exploded perspective view of another illustrative attachment arm 510 of a frame 500 and a soft tissue anchor 520 is shown. Fig. 10B5 is a perspective view of an illustrative attachment arm 510 of a frame 500 assembled with a soft tissue anchor 520. The frame 500 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 520 can be configured to be assembled with the frame 500 and an implant 12 (not explicitly shown) to releasably secure the implant to the frame 500. Although the soft tissue anchor 520 is described with respect to a single attachment arm 510, it should be understood that the soft tissue anchor 520 can be provided in any number of attachment arms 510 as desired.

[0214] The soft tissue anchor 520 may include a proximal head 522 configured to press against the implant 12; and a distal fixed end 524 configured to penetrate tissue. An elongated intermediate connecting portion or handle 526 may extend between the proximal head 522 and the distal fixed end 524. It is contemplated that the width of the proximal head 522 may be greater than the width of the intermediate connecting portion 526. The proximal head 522 may include a top side 534 facing away from the implant 12 when the implant 12 is attached to the frame 500, a bottom side 536 facing toward or juxtaposed with the implant 12 when the implant 12 is attached to the frame 500, a first lateral side 538 extending between the top side 534 and the bottom side 536, and a second lateral side 540 opposite the first lateral side 538 and extending between the top side 534 and the bottom side 536. The top side 534, the bottom side 536, the first lateral side 538, and the second lateral side 540 can collectively define a channel 542 extending from a first end 544 to a second end 546 of the proximal head 522. The channel 542 can be sized and shaped to allow the proximal head 522 to slide on the attachment arm 510 (e.g., Fig. 10B ), while preventing the proximal head 522 from accidentally becoming detached from the attachment arm 510 prior to assembly with the soft tissue anchor 520.

[0215] The distal fixation end 524 can be generally "V" shaped or pointed and can include a first barb 528a and a second barb 528b (collectively 528). The distal fixation end 524 can be shaped so that once the distal fixation end 524 is assembled with the frame 500 and / or body tissue, the proximal retraction of the soft tissue anchor 520 can be prevented or hindered. For example, the barbs 528 can each include a proximal end 530a, 530b (collectively 530) radially spaced from the intermediate connecting portion or handle 526 and a distal end 532a, 532b (collectively 532) in contact with or coupled to the distal fixation end 524. In some cases, less than two or more than two barbs 528 can be provided. In some cases, the proximal ends 530 of the barbs 528 can be configured to deflect radially inwardly to advance the soft tissue anchor 520 distally through the frame 500, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Fig. 10A ), however, this is not necessary. The distal fixed end 524 or distal tip of the soft tissue anchor 520 is configured to guide the soft tissue anchor 520 when it is advanced into the body tissue. The barbs 528 are angled or inclined so that the soft tissue anchor 520 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 520 to the proximal side is difficult or blocked. This can help ensure that once the soft tissue anchor 520 is assembled with the framework 500 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 528 can vary. It is conceivable that the barbs 528 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 528 can be used to help fix the soft tissue anchor 520 to the framework 500 and the implant 12 and / or in the tissue.

[0216] The intermediate connecting portion or handle 526 can be an elongated rod having a generally cylindrical shape; however, the intermediate connecting portion or handle 526 can have other shapes as desired. Although the intermediate connecting portion or handle 526 is shown as having a cross-sectional dimension of a generally uniform diameter, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 526 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 526 can decrease from the proximal head 522 toward the distal fixed end 524. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 520 can be formed as a single unitary structure or a series of components attached to each other as desired.

[0217] It is also contemplated that the soft tissue anchor 520 may be of other configurations. For example, the soft tissue anchor 520 may be a barbed "U" shaped tissue anchor similar to a staple, having two distally extending legs. In this case, the barbed edges or legs penetrate and secure within the tissue, while the connecting portion or bridge of the "U" provides a channel to engage the attachment arm 510 and provides support to press the implant 12 between the barbed legs. In other embodiments, the soft tissue anchor 520 may be a screw with a threaded distal region. The threaded region may penetrate the tissue, while the head of the screw provides support to hold down the implant. This is just one example.

[0218] The attachment arm 510 can include a first flexible arm 512a and a second flexible arm 512b (collectively 512) adjacent its free end. It is contemplated that the flexible arm 512 can be formed by removing some material from the attachment arm 510, or otherwise shaping the attachment arm 510 to include first and second flexible arms 512a / 512b with a slot or opening therebetween, although other techniques can be used as desired. The flexible arms 512 can each include a proximal portion 511a, 511b (collectively 511) extending generally parallel to the longitudinal axis 504 of the attachment arm 510; and a distal portion 513a, 513b (collectively 513) extending at a non-parallel angle to the longitudinal axis 504 of the attachment arm 510. The arms 512 can define a gap 516 or an area without material therebetween. In some cases, the proximal end of the gap 516 can include a strain relief notch 518. The gap 516 can allow the flexible arms 512 to flex inwardly toward the longitudinal axis 504, as indicated by arrows 550a, 550b (collectively 550), and thus the flexible arms 512 can flex inwardly toward each other. The free ends 514a, 514b (collectively 514) of the flexible arms 512 can each bend away from the longitudinal axis 504 of the attachment arm 510, such that, for example, a width 552 of the attachment arm 510 adjacent the free end 514 is greater than a width 554 of the proximal portion 511 of the flexible arm and / or the attachment arm 510 adjacent the strain relief 518. While the free end 514 is described as having a generally curved configuration, it is contemplated that the free end 514 can include other configurations that increase the width 552 at the free end 514 relative to the width 554 adjacent the strain relief 518.

[0219] The flexible arms 512 can be configured to temporarily flex toward (or generally orthogonal to) the longitudinal axis 504 of the attachment arm 510, and thus toward each other, as indicated at arrows 550a, 550b (collectively 550). It is contemplated that the flexible arms 512 can be configured to flex in the direction indicated at arrow 550 to temporarily narrow the width 552 adjacent the free end 514 in response to an applied force, and return to an original configuration in the absence of an applied force. The width 548 of the channel 542 of the proximal head 522 of the soft tissue anchor 520 can be greater than the width 554 of the attachment arm 510 adjacent the strain relief 518, and less than the width 552 at the free end 514 in its relaxed or unbiased configuration. Deflection of the flexible arms 512 in the direction 550 can temporarily reduce the width 552 to allow the flexible arms 512 to be inserted into the channel 542 of the proximal head 522 of the soft tissue anchor 520. The soft tissue anchor 520 can slide along the attachment arm 510 (or the attachment arm 510 slides within the channel 542) until the soft tissue anchor 520 is disposed on the proximal portion 511 of the flexible arm 512. Once the soft tissue anchor 520 is disposed on the proximal portion 511 of the flexible arm 512, the flexible arm 512 can return to or toward its original unbiased configuration, thereby increasing the width 552 at the free end 514. In the absence of an applied force, the distal portion 513 and the free end 514 extend laterally beyond the width 548 of the channel 542 to retain the soft tissue anchor 520 on the attachment arm 510. The width 548 of the channel 542 can be greater than the width 554 of the proximal portion 511 of the flexible arm 512 so that the soft tissue anchor 520 can slide freely on that portion of the attachment arm 510. Alternatively, the width 548 of the channel 542 can be substantially the same as the width 554 of the proximal portion 511 of the flexible arm 512 to provide a friction fit and further secure the soft tissue anchor relative to the attachment arm 510. The implant 12 can be attached adjacent to the second surface 508 of the frame 200 while or after the soft tissue anchor 520 is assembled with the frame 500. It is contemplated that the soft tissue anchor 520 can penetrate or pierce the implant 12 (similar to Figure 6B ) to secure the implant 12 to the frame 500 for delivery to the target site.

[0220] You can use something similar to the above Figures 2 to 4The delivery system and method described delivers the framework 500, implant 12 and soft tissue anchor 520 to the body. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to the framework 500 and extend from the body so that once it is separated from the implant 12, the framework 500 can be retrieved. Then a tool can be advanced to separate the soft tissue anchor 520 from the framework 500. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 522 of the soft tissue anchor 520. Then, a force can be applied to advance the soft tissue anchor 520 distally so that the distal fixed end 524 or the distal top pierces the tissue. The tool can be repositioned to align with another soft tissue anchor 520, and a force is applied to the soft tissue anchor 520 to separate it from the framework 500. This can be repeated for each soft tissue anchor 520. This can allow for deployment of multiple soft tissue anchors 520 without requiring the clinician to individually load each soft tissue anchor 520 into the tool and repeatedly insert and remove the tool. Once each soft tissue anchor 520 is driven into the tissue, the frame 500 can be retracted from the body. The retraction of the frame 500 can apply a lateral pulling force to the attachment arms 510, which in turn can bias the flexible arms 512 inwardly 550, thereby allowing the attachment arms 510 to pass through the channels 542 of the proximal heads 522 of the soft tissue anchors 520, thereby releasing the frame 500 from the soft tissue anchors 520.

[0221] Fig.11A An exploded perspective view of another illustrative attachment arm 610 of the frame 600 and soft tissue anchor 620 is shown. Fig. 11B 6 is a side view of an illustrative attachment arm 610 of a frame 600 assembled with a soft tissue anchor 620 and an implant 12. The frame 600 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 620 can be configured to be assembled with the frame 600 and an implant 12 (not explicitly shown) to releasably secure the implant 12 to the frame 600. Although the soft tissue anchor 620 is described with respect to a single attachment arm 610, it should be understood that the soft tissue anchor 620 can be provided in any number of attachment arms 610 as desired.

[0222] The soft tissue anchor 620 may include a proximal head 622 configured to press against the implant 12; and a distal fixed end 624 configured to penetrate tissue. An elongated intermediate connecting portion or handle 626 may extend between the proximal head 622 and the distal fixed end 624. It is contemplated that the width of the proximal head 622 may be greater than the width of the intermediate connecting portion 626. The proximal head 622 may include a top side 634 facing away from the implant 12 when the implant 12 is attached to the frame 600, a bottom side 636 facing the implant 12 when the implant 12 is attached to the frame 600, a first lateral side 638 extending between the top side 634 and the bottom side 636, and a second lateral side 640 opposite the first lateral side 638 and extending between the top side 634 and the bottom side 636. The top side 634, the bottom side 636, the first lateral side 638, and the second lateral side 640 can collectively define a channel 642 extending from a first end 644 to a second end 646 of the proximal head 622. The channel 642 can be sized and shaped to allow the proximal head 622 to slide on the attachment arm 610 (e.g., Fig. 11B ), while preventing the proximal head 622 from accidentally becoming detached from the attachment arm 610 prior to assembly with the soft tissue anchor 620.

[0223] The distal fixation end 624 can be generally "V" shaped or pointed and can include a first barb 628a and a second barb 628b (collectively 628). The distal fixation end 624 can be shaped so that once the distal fixation end 624 is assembled with the frame 600 and / or body tissue, the proximal retraction of the soft tissue anchor 620 can be prevented or hindered. For example, the barbs 628 can each include a proximal end 630a, 630b (collectively 630) radially spaced from the intermediate connecting portion or handle 626 and a distal end 632a, 632b (collectively 632) in contact with or coupled to the distal fixation end 624. In some cases, less than two or more than two barbs 628 can be provided. In some cases, the proximal ends 630 of the barbs 628 can be configured to deflect radially inwardly to advance the soft tissue anchor 620 distally through the frame 600, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Fig.11A), however, this is not necessary. The distal fixed end 624 of the soft tissue anchor 620 is configured to guide the soft tissue anchor 620 when it is advanced into the body tissue. The barbs 628 are angled or inclined so that the soft tissue anchor 620 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 620 to the proximal side is difficult or blocked. This can help ensure that once the soft tissue anchor 620 is assembled with the framework 600 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 628 can vary. It is conceivable that the barbs 628 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 628 can be used to help fix the soft tissue anchor 620 to the framework 600 and the implant 12 and / or in the tissue.

[0224] The intermediate connecting portion or handle 626 can be an elongated rod having a generally cylindrical shape; however, the intermediate connecting portion or handle 626 can have other shapes as desired. Although the intermediate connecting portion or handle 626 is shown as having a cross-sectional dimension of a generally uniform diameter, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 626 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 626 can decrease from the proximal head 622 toward the distal fixed end 624. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 620 can be formed as a single unitary structure or a series of components attached to each other as desired.

[0225] It is also conceivable that the soft tissue anchor 620 can adopt other configurations. For example, the soft tissue anchor 620 can be a barbed "U" shaped tissue anchor similar to a suture staple, which has two legs extending distally. In this case, the barbed edge or legs penetrate and fix in the tissue, and the connecting portion or bridge of the "U" provides a channel to engage the attachment arm 610 and provides support to press the implant 12 between the barbed legs. In other embodiments, the soft tissue anchor 620 can have a threaded distal region. The threaded region can penetrate the tissue, and the head of the screw provides support to hold the implant. This is just an example.

[0226] The attachment arm 610 may include a raised stop 612 positioned adjacent to its free end 614. The stop 612 may extend from a first surface 606 of the frame 600 (e.g., a surface facing away from the implant 12) in a direction away from the implant 12. However, it is contemplated that the stop 612 may extend from a second surface 608 of the frame 600 (e.g., a surface facing the implant 12) in a direction toward the implant 12. In some embodiments, the stop 612 may be disposed on both the first and second surfaces 606, 608. The stop 612 may include a distal side 616 and a proximal side 618. In some cases, the distal side 616 may include an inclined surface that increases in height in the proximal direction. For example, the height of the distal side 616 may increase in a curved or inclined manner. This may facilitate assembly of the soft tissue anchor 620 with the attachment arm 610. In some cases, the proximal side 618 may extend at an angle orthogonal to the first surface 606 of the attachment arm 610. In other cases, the proximal side 618 can have a steeper curve or slope than the distal side 616. The proximal side 618 can be configured to provide a mechanical stop between the first end 644 of the proximal head of the soft tissue anchor 620 and the detent 612. It is contemplated that the detent 612 can be configured to deform or flex when a force is applied to the attachment arm 610 to allow the soft tissue anchor 620 to be separated from the attachment arm 610.

[0227] To assemble the soft tissue anchor 620 with the attachment arm 610, the free end 614 of the attachment arm 610 can be inserted into the channel 642 of the proximal head 622 of the soft tissue anchor 620 adjacent to its second end 646. The attachment arm 610 can be advanced within the channel 642 until the detent 612 is positioned outside of the channel 642 adjacent to the first end 644 of the proximal head 622. Alternatively, the soft tissue anchor 620 can be advanced relative to the attachment arm 610 until the detent 612 is positioned outside of the channel 642 adjacent to the first side of the proximal head 622. The width 648 of the channel 642 of the proximal head 622 of the soft tissue anchor 620 can be greater than the width 650 of the attachment arm 610. The width 648 of the channel 642 can be greater than the width 650 of the attachment arm 610 so that the soft tissue anchor 620 can slide freely on that portion of the attachment arm 610. Alternatively, the width 648 of the channel 642 can be substantially the same as the width 650 of the attachment arm 610 to provide a friction fit and further secure the soft tissue anchor 620 relative to the attachment arm 610. Simultaneously with or after assembling the soft tissue anchor 620 with the frame 600, the implant 12 can be attached adjacent to the second surface 608 of the frame 600. It is contemplated that the soft tissue anchor 620 can penetrate or pierce the implant 12 (see, e.g., Fig. 11B ) to secure the implant 12 to the frame 600 for delivery to the target site.

[0228] You can use something similar to the above Figures 2 to 4 The delivery system and method described delivers the framework 600, implant 12 and soft tissue anchor 620 to the body. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to the framework 600 and extend from the body so that once it is separated from the implant 12, the framework 600 can be retrieved. Then a tool can be advanced to separate the soft tissue anchor 620 from the framework 600. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 622 of the soft tissue anchor 620. Then, a force can be applied to advance the soft tissue anchor 620 distally so that the distal fixed end 624 or the distal top pierces the tissue. The tool can be repositioned to align with another soft tissue anchor 620, and a force is applied to the soft tissue anchor 620 to separate it from the framework 600. This can be repeated for each soft tissue anchor 620. This can allow for deployment of multiple soft tissue anchors 620 without requiring the clinician to individually load each soft tissue anchor 620 into the tool and repeatedly insert and remove the tool. Once each soft tissue anchor 620 is driven into the tissue, the frame 600 can be retracted from the body. The retraction of the frame 600 can apply a pulling force to the attachment arm 610, which in turn can deform the first end 644 of the detent 612 against the proximal head 622, thereby allowing the attachment arm 610 to pass through the channel 642 of the proximal head 622 of the soft tissue anchor 620 and release the frame 600 from the soft tissue anchor 620.

[0229] Fig. 12A An exploded perspective view of another illustrative attachment arm 710 of the frame 700 and soft tissue anchor 720 is shown. Fig. 12B 7 is a partial cross-sectional view of an illustrative attachment arm 710 of a frame 700 assembled with a soft tissue anchor 720 and an implant 12. The frame 700 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 720 can be configured to be assembled with the frame 700 and an implant 12 (not explicitly shown) to releasably secure the implant 12 to the frame 700. Although the soft tissue anchor 720 is described with respect to a single attachment arm 710, it should be understood that the soft tissue anchor 720 can be provided in any number of attachment arms 710 as desired.

[0230] The soft tissue anchor 720 may include a proximal head 722 configured to press against the implant 12; and a distal fixed end 724 configured to penetrate tissue. An elongated intermediate connecting portion or handle 726 may extend between the proximal head 722 and the distal fixed end 724. It is contemplated that the width of the proximal head 722 may be greater than the width of the intermediate connecting portion 726. The proximal head 722 may include a top side 734 facing away from the implant 12 when the implant 12 is attached to the frame 700, a bottom side 736 facing toward or juxtaposed with the implant 12 when the implant 12 is attached to the frame 700, a first lateral side 738 extending between the top side 734 and the bottom side 736, and a second lateral side 740 opposite the first lateral side 738 and extending between the top side 734 and the bottom side 736. The top side 734, the bottom side 736, the first lateral side 738, and the second lateral side 740 can collectively define a channel 742 extending from a first end 744 to a second end 746 of the proximal head 722. The channel 742 can be sized and shaped to allow the proximal head 722 to slide on the attachment arm 710 (e.g., Fig. 12B 742 ). The first and second detents 750a, 750b (collectively 750) may extend from the top side 734 into the channel 742. The detents 750 may be viewed as protrusions. Alternatively or additionally, the detents 750 may extend from the bottom side 736 (not explicitly shown) and / or the lateral sides 738, 740 into the channel 742. It is contemplated that less than two (e.g., one) or more than two (e.g., three, four, five, or more) detents 750 may extend from the surface of the proximal head 722 into the channel 742. In other cases, the detents 750 may extend from a lug or other portion of the proximal head 722 without extending into the channel 742. Although the detents 750 are shown as having a generally hemispherical shape, it is contemplated that the detents 750 may take any desired shape, including, but not limited to, conical, cubic, pyramidal, and the like. Furthermore, while the detents 750 are shown positioned in a linear arrangement, this is not required. The detents 750 may be positioned in any configuration, symmetrical or asymmetrical, as desired.

[0231] The distal fixing end 724 can be generally "V" shaped or pointed and can include a first barb 728a and a second barb 728b (collectively 728). The distal fixing end 724 can be shaped so that once the distal fixing end 724 is assembled with the frame 700 and / or body tissue, the proximal retraction of the soft tissue anchor 720 can be prevented or hindered. For example, the barbs 728 can each include a proximal end 730a, 730b (collectively 730) radially spaced from the intermediate connecting portion or handle 726 and a distal end 732a, 732b (collectively 732) in contact with or coupled to the distal fixing end 724. In some cases, less than two or more than two barbs 728 can be provided. In some cases, the proximal ends 730 of the barbs 728 can be configured to deflect radially inwardly to advance the soft tissue anchor 720 distally through the frame 700, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Fig. 12A ), however, this is not necessary. The distal fixed end 724 or distal tip of the soft tissue anchor 720 is configured to guide the soft tissue anchor 720 when it is advanced into the body tissue. The barbs 728 are angled or tilted so that the soft tissue anchor 720 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 720 to the proximal side is difficult or blocked. This can help ensure that once the soft tissue anchor 720 is assembled with the framework 700 and / or the implant 12 and / or implanted in the tissue, it will self-anchor. The angle and / or length of the barbs 728 can vary. It is conceivable that the barbs 728 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barbs 728 can be used to help fix the soft tissue anchor 720 to the framework 700 and the implant 12 and / or in the tissue.

[0232] The intermediate connecting portion or handle 726 can be an elongated rod having a generally cylindrical shape; however, the intermediate connecting portion or handle 726 can have other shapes as desired. Although the intermediate connecting portion or handle 726 is shown as having a cross-sectional dimension of a generally uniform diameter, it is contemplated that the cross-sectional dimension of the intermediate connecting portion or handle 726 can vary along its length. For example, the cross-sectional dimension of the intermediate connecting portion or handle 726 can decrease from the proximal head 722 toward the distal fixed end 724. This is merely an example. Other configurations can be used as desired. It is contemplated that the soft tissue anchor 720 can be formed as a single integral structure or a series of components attached to each other as desired.

[0233] It is also conceivable that the soft tissue anchor 720 can adopt other configurations. For example, the soft tissue anchor 720 can be a barbed "U" shaped tissue anchor similar to a suture staple, which has two legs extending distally. In this case, the barbed edge or legs penetrate and fix in the tissue, and the connecting portion or bridge of the "U" provides a channel to engage the attachment arm 710 and provides support to press the implant 12 between the barbed legs. In other embodiments, the soft tissue anchor 720 can have a threaded distal region. The threaded region can penetrate the tissue, and the head of the screw provides support to hold the implant. This is just an example.

[0234] The attachment arm 710 includes a first surface 706 (e.g., a surface facing away from the implant 12) and a second surface 708 (e.g., a surface facing the implant 12), thereby defining a thickness 718 therebetween. The attachment arm 710 may include a first hole or recess 712a positioned adjacent to its free end 714 and a second hole or recess 712b (collectively referred to as 712) spaced laterally from the first recess 712a. In some cases, the recess 712 may extend partially through the thickness 718 of the attachment arm 710. In other cases, the recess 712 may extend completely through the thickness 718 of the attachment arm 710 (e.g., from the first surface 706 to the second surface 708). It is also contemplated that some recesses 712 may extend partially through the thickness 718, while others extend completely through the thickness 718 of the attachment arm 710. The attachment arm 710 may include less than two (e.g., one) or more than two (e.g., three, four, five or more) recesses 712. Although the recesses 712 are shown as having a generally hemispherical shape to generally mate with the detent 750, it is contemplated that the recesses 712 may take any desired shape, including, but not limited to, conical, cubic, pyramidal, etc. In addition, although the recesses 712 are shown as being positioned in a linear arrangement, this is not required. The recesses 712 may be positioned in any configuration, symmetrical or asymmetrical, as desired. It is contemplated that the configuration of the recesses 712 may mirror or match the configuration of the detent 750 in the proximal head 722 of the soft tissue anchor 720.

[0235] To assemble the soft tissue anchor 720 with the attachment arm 710, the free end 714 of the attachment arm 710 can be inserted into the channel 742 of the proximal head 722 of the soft tissue anchor 720 adjacent to the second end 746 thereof. The attachment arm 710 can be advanced within the channel 742 until the detent 750 of the proximal head 722 engages the recess 712 of the attachment arm 710. For example, the first detent 750a of the soft tissue anchor 720 can be configured to be disposed within or otherwise engage the first recess 712a of the attachment arm 710, and the second detent 750b of the soft tissue anchor 720 can be configured to be disposed within or otherwise engage the second recess 712b of the attachment arm 710 to form a mechanical interlock between the two components, such as Fig. 12B As shown. The width 748 of the channel 742 of the proximal head 722 of the soft tissue anchor 720 can be greater than the width 716 of the attachment arm 710. The width 748 of the channel 742 can be greater than the width 716 of the attachment arm 710 so that the soft tissue anchor 720 can slide freely on that portion of the attachment arm 710. Alternatively, the width 748 of the channel 742 can be substantially the same as the width 716 of the attachment arm 710 to provide a friction fit and further secure the soft tissue anchor 720 relative to the attachment arm 710. The implant 12 can be attached adjacent to the second surface 708 of the frame 700 while or after the soft tissue anchor 720 is assembled with the frame 700. It is contemplated that the soft tissue anchor 720 can penetrate or pierce the implant 12 (see, for example, Fig. 12B ) to secure the implant 12 to the frame 700.

[0236] It is contemplated that positioning the detents 750 and recesses 712 at staggered locations about the width 748 of the channel 742 and the width 716 of the attachment arm 710 can facilitate assembly by preventing a detent (e.g., detent 750b) from prematurely engaging a recess (e.g., recess 712a) intended to correspond to a different detent (e.g., detent 750a), however this is not required. For example, the first recess 712a can be laterally offset from the longitudinal axis 702 of the attachment arm 710 in a first direction, and the second recess 712b can be laterally offset from the longitudinal axis 702 of the attachment arm 710 in a second direction opposite the first direction. The corresponding detent 750 on the proximal head 722 can be similarly arranged so that the detent 750 can be assembled with the recess 712.

[0237] You can use something similar to the above Figures 2 to 4The delivery system and method described delivers the framework 700, implant 12 and soft tissue anchor 720 to the body. Once the implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to the framework 700 and extend from the body so that once it is separated from the implant 12, the framework 700 can be retrieved. Then a tool can be advanced to separate the soft tissue anchor 720 from the framework 700. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 722 of the soft tissue anchor 720. Then, a force can be applied to advance the soft tissue anchor 720 distally so that the distal fixed end 724 or the distal top pierces the tissue. The tool can be repositioned to align with another soft tissue anchor 720, and a force is applied to the soft tissue anchor 720 to separate it from the framework 700. This can be repeated for each soft tissue anchor 720. This can allow for deployment of multiple soft tissue anchors 720 without requiring the clinician to individually load each soft tissue anchor 720 into the tool and repeatedly insert and remove the tool. Once each soft tissue anchor 720 is driven into the tissue, the frame 700 can be retracted from the body. The retraction of the frame 700 can apply a pulling force to the attachment arm 710, which in turn can disengage the detent 750 from the recess 712, thereby allowing the attachment arm 710 to pass through the channel 742 of the proximal head 722 of the soft tissue anchor 720 and release the frame 700 from the soft tissue anchor 720.

[0238] Fig.13A A perspective view of the frame 800 and another illustrative attachment arm 810 of the soft tissue anchor 12 is shown with the implant 12 attached thereto. Fig. 13B yes Fig.13A 800, retainer 840, and an illustrative attachment arm 810 of a frame 800, a retainer 840, and a soft tissue anchor 820. The frame 800 can be similar in form and function to the frame 100 described herein. The soft tissue anchor 820 can be configured to be assembled with the frame 800 and the implant 12 to releasably secure the implant to the frame 800. Fig. 13C is Fig.13A 13C-13C of the cross-sectional view of the illustrative attachment arm 810. Although the soft tissue anchor 820 is described with respect to a single attachment arm 810, it should be understood that the soft tissue anchor 820 can be provided in any number of attachment arms 810 as desired.

[0239] exist FIG. 13A to FIG. 13CIn the illustrative embodiment of the present invention, the soft tissue anchor 820 can be removably coupled to the attachment arm 810 via a retainer 840. The retainer 840 can be configured to slide over the free end 814 of the attachment arm 810. Generally, the soft tissue anchor 820 can be advanced through the hole 842 in the retainer 840 and the hole 812 in the attachment arm 810. The retainer 840 can include a feature that is configured to engage a mating feature of the soft tissue anchor 820 to releasably secure the soft tissue anchor 820 to the feature, however this is not required.

[0240] The soft tissue anchor 820 may include a proximal head 822 configured to press against the implant 12; and a distal fixed end 824 configured to penetrate the tissue. An elongated intermediate connecting portion 826 may extend between the proximal head 822 and the distal fixed end 824. In some cases, the proximal head 822 may include one or more chamfered surfaces. The proximal head 822 may be in the form of a truncated cone. The proximal head 822 may have an upper surface 821 and a lower surface 823. The length 833 and width 835 of the upper surface 821 may be greater than the lower surface 823, but this is not required. The lower surface 823 may be connected to the intermediate connecting portion 826 or positioned adjacent to the intermediate connecting portion 826. The proximal head 822 may also include a first lateral side 825, a second lateral side 827 opposite to the first lateral side 825, a third lateral side 829, and a fourth lateral side 831 opposite to the third lateral side 829. In some cases, the lateral sides may be beveled at an acute angle to the direction of insertion of the soft tissue anchor 820. The proximal head 822 may take other shapes as desired, such as, but not limited to, a rectangular prism, a cuboid, an ellipsoid, and the like.

[0241] The distal fixation end 824 can have a barbed "U" shape, including a first leg 834a and a second leg 834b (collectively referred to as 834) extending from the intermediate connecting portion 826. The legs 834 can be laterally spaced apart to define a channel 836 therebetween. The first leg 834a can include a distal tip including a first barb 828a, and the second leg 834b can include a distal tip including a second barb 828b (collectively referred to as 828). The distal fixation end 824 can be shaped so that once the distal fixation end 824 is assembled with the frame 800 and / or body tissue, the proximal retraction of the soft tissue anchor 820 can be prevented or hindered. For example, the barbs 828 can each include a proximal end 830a, 830b (collectively referred to as 830) radially spaced apart from the corresponding leg 834 and a distal end 832a, 832b (collectively referred to as 832) contacting or coupled to the distal fixation end 824. In some cases, less than two or more than two barbs 828 may be provided. In some cases, the proximal ends 830 of the barbs 828 may be configured to deflect radially inwardly to advance the soft tissue anchor 820 distally through the frame 800, the retainer 840, the implant 12, and / or body tissue, and to resume an expanded, outwardly extending configuration (e.g., Fig. 13B and Fig. 13C ), however this is not necessary. The distal fixed end 824 or distal tip of the leg 834 of the soft tissue anchor 820 is configured to guide the soft tissue anchor 820 when it is advanced into the body tissue. The barb 828 is angled or tilted so that the soft tissue anchor 820 is easily advanced distally through the tissue, but the retraction of the soft tissue anchor 820 to the proximal side is difficult or blocked. This can help ensure that once the soft tissue anchor 820 is assembled with the framework 800 and / or the implant 12 and / or implanted in the tissue, it will be self-anchored. The angle and / or length of the barb 828 can vary. It is conceivable that the barb 828 can have a structure or shape different from the angled surface, including but not limited to curves, steps, etc. It is conceivable that other structural features that replace or supplement the barb 828 can be used to help fix the soft tissue anchor 820 to the framework 800 and the implant 12 and / or in the tissue.

[0242] The intermediate connecting portion 826 can connect the proximal head 822 and the distal fixation end 824. In some cases, the intermediate connecting portion 826 can form a bridge between the first and second legs 834a, 834b. It is contemplated that the soft tissue anchor 820 can be formed as a single unitary structure or a series of components attached to each other as desired.

[0243] It is also contemplated that the soft tissue anchor 820 may be of other configurations. For example, the soft tissue anchor 820 may be any of the soft tissue anchors described herein. In other embodiments, the soft tissue anchor 820 may be a screw having a threaded distal region. The threaded region may penetrate the tissue, while the head of the screw provides support to hold down the implant. This is just one example.

[0244] The attachment arm 810 may include a hole 812 configured to receive a portion of the soft tissue anchor 820. The hole 812 may have a rectangular cross-sectional shape similar to the approximate cross-sectional shape of the proximal head 822 of the soft tissue anchor 820 and extend through the thickness of the attachment arm 810 from a first surface 806 facing away from the implant 12 when the implant 12 is attached to the frame 800 (e.g., a first surface facing away from a target site in the body) and a second surface 808 facing the example implant 12 (e.g., a second surface facing a target site in the body). The hole 812 may be sized and shaped to allow the proximal head 822 of the soft tissue anchor 820 to pass therethrough. For example, the hole 812 may have a width 816 greater than a width 835 of the proximal head 822 and a length 818 greater than a length 833 of the proximal head 822.

[0245] The retainer 840 may include a top side 844 facing away from the implant 12 when the implant 12 is attached to the frame 800, a bottom side 846 facing the implant 12 when the implant 12 is attached to the frame 800, a first lateral side 848 extending between the top side 844 and the bottom side 846, and a second lateral side 850 opposite the first lateral side and extending between the top side 844 and the bottom side 846. The top side 844, the bottom side 846, the first lateral side 848, and the second lateral side 850 can collectively define a channel 852 extending from a first end 854 to a second end 856 of the retainer 840. The channel 852 can be sized and shaped to allow the retainer 840 to slide on the attachment arm 810 (e.g., Fig.13A840) while preventing the retainer 840 from accidentally disengaging from the attachment arm 810 prior to being assembled with the soft tissue anchor 820. The retainer 840 may also include a first opening 858 in the top side 844 and a second opening 860 defined in the bottom side 846. The first and second openings 858, 860 may have a rectangular cross-sectional shape similar to the approximate cross-sectional shape of the proximal head 822 of the soft tissue anchor 820, however this is not required. The first and second openings 858, 860 may be generally aligned to define a hole 842 extending from the top side 844 to the bottom side 846. The first and second openings 858, 860 may have similar or identical diameters as desired, or may have different diameters. In some embodiments, the first opening 858 may have a width 862 that is less than the width 835 of the proximal head 822 and a length 864 that is less than the length 833 of the proximal head 822, while the second opening 860 may have a width that is greater than the width 835 of the proximal head 822 and a length 864 that is greater than the length 833 of the proximal head 822.

[0246] To assemble the soft tissue anchor 820 with the attachment arm 810, the retainer 840 can be advanced over the free end 814 of the attachment arm 810 until the hole 842 of the retainer 840 is substantially aligned with the hole 812 of the attachment arm 810. The distal fixed end 824 of the soft tissue anchor 820 is then advanced through the holes 812, 842 in a direction from the top side 844 toward the bottom side 846 of the retainer 840. The soft tissue anchor 820 can be advanced until the first, second, third, and fourth surfaces 825, 827, 829, 831 engage the sidewalls of the first opening 858 in the retainer 840. The surfaces 825, 827, 829, 831 can form a friction fit with the first opening 858 such that a first force secures the soft tissue anchor 820 within the first opening 858 and a second force greater than the first force pushes the soft tissue anchor 820 through the first opening 858, the hole 842, and the second opening 860. It is contemplated that during assembly, the implant 12 may be positioned adjacent the second surface 808 of the frame 800 and / or the bottom side 846 of the retainer 840 such that the soft tissue anchor 820 pierces the implant 12 and secures it to the frame 800 .

[0247] You can use something similar to the above Figures 2 to 4The delivery system and method described are delivered to the body by framework 800, implant 12 and soft tissue anchor 820. Once implant 12 is positioned at the target position, it can be temporarily fixed using, for example, bone screws. The delivery system can be released and retracted from the entrance to allow insertion of other devices. In some cases, a tether can be connected to framework 800 and extend from the body so that once it is separated from implant 12, framework 800 can be retrieved. Then a tool can be advanced to separate soft tissue anchor 820 from framework 800. In some cases, the tool can be similar to a punch-type tool, but this is not necessary. The tool can be aligned with the proximal head 822 of soft tissue anchor 820. Then, force can be applied to advance soft tissue anchor 820 distally so that the distal fixed end 824 or distal top of the leg pierces the tissue. It is contemplated that when a force is applied to the proximal head 822, the top side 844 of the retainer 840 may bend, deflect, deform, or break, thereby allowing the proximal head 822 to pass through the first opening 858 or to disengage from the first opening 858. In some cases, the angles or inclined surfaces of the first, second, third, and fourth surfaces 825, 827, 829, 831 may facilitate the passage of the proximal head 822 through the first opening 858. As described above, the second opening 860 may be sized so that the proximal head 822 can easily pass through it, however this is not required. The tool may be repositioned to align with another soft tissue anchor 820, and a force may be applied to the soft tissue anchor 820 to separate it from the frame 800. This may be repeated for each soft tissue anchor 820. This may allow for the deployment of multiple soft tissue anchors 820 without requiring the clinician to load each soft tissue anchor 820 individually into the tool and repeatedly insert and remove the tool.

[0248] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. An implant delivery system, comprising: a delivery shaft comprising a proximal portion and a distal portion; as well as a frame coupled to the distal portion of the delivery shaft, wherein the frame includes a body portion and a plurality of attachment arms extending away from the body portion; and at least one soft tissue anchor releasably secured to a free end of at least one of the plurality of attachment arms; and An implant is releasably secured to the framework via the at least one soft tissue anchor.

2. The implant delivery system of claim 1, wherein: The at least one soft tissue anchor is configured to remain with the implant within the body.

3. The implant delivery system according to any one of claims 1 to 2, wherein: The at least one tissue anchor includes a proximal head, a distal fixation end, and an intermediate connecting portion extending between the proximal head and the distal fixation end.

4. The implant delivery system of claim 3, wherein: The proximal head is generally disc-shaped.

5. The implant delivery system according to any one of claims 3 to 4, wherein: The distal fixation end includes a first barb and a second barb.

6. An implant delivery system according to any one of claims 3 to 5, wherein: The intermediate connecting portion includes an elongated rod.

7. The implant delivery system of any one of claims 3 to 6, further comprising a recess formed in said at least one of said plurality of attachment arms adjacent said free end thereof.

8. The implant delivery system of claim 7, wherein: The recess extends partially through the thickness of the at least one of the plurality of attachment arms to define an area of ​​reduced thickness.

9. The implant delivery system of claim 8, further comprising a through hole extending through the region of reduced thickness.

10. An implant delivery system according to any one of claims 7 to 9, wherein: The recess is configured to receive the proximal head of the at least one soft tissue anchor therein.

11. The implant delivery system according to any one of claims 9 to 10, wherein: The intermediate connecting portion extends through the through hole.

12. An implant delivery system according to any one of claims 9 to 11, wherein: Under an applied force, the proximal head of the at least one soft tissue anchor is configured to push through the region of reduced thickness of the at least one of the plurality of attachment arms to release the at least one soft tissue anchor from the frame.

13. The implant delivery system of claim 12, wherein: The region of reduced thickness is configured as a fracture.

14. The implant delivery system of claim 12, wherein: The region of reduced thickness is configured to deform to allow the proximal head to pass through the through hole.

15. An implant delivery system according to any one of claims 3 to 6, wherein: The proximal head also includes one or more radially extending lugs.

16. The implant delivery system of claim 15, further comprising a hole formed through said at least one of said plurality of attachment arms adjacent said free end thereof.

17. The implant delivery system of claim 16, wherein: The hole extends through a thickness of the at least one of the plurality of attachment arms.

18. An implant delivery system according to any one of claims 16 to 17, further comprising a circumferentially extending groove formed in the side wall of the hole, wherein the circumferentially extending groove is positioned between a first surface of at least one of the plurality of attachment arms and a second surface of at least one of the plurality of attachment arms.

19. The implant delivery system of claim 18, further comprising at least one axially extending slot formed in a side wall of the hole, the at least one axially extending slot extending from the second surface of at least one of the plurality of attachment arms to the circumferentially extending groove.

20. The implant delivery system of claim 19, wherein: During assembly of the at least one soft tissue anchor with the at least one of the plurality of attachment arms and deployment of the at least one soft tissue anchor from the at least one of the plurality of attachment arms, the one or more radially extending lugs are configured to slide within the at least one axially extending slot.

21. An implant delivery system according to any one of claims 18 to 19, wherein: The one or more radially extending lugs may be rotatably disposed within the circumferentially extending groove during delivery of the implant to a target location.

22. An implant delivery system according to any one of claims 3 to 6, wherein: The proximal head also includes one or more radially extending detents.

23. The implant delivery system of claim 22, wherein: The detent extends around the circumference of the proximal head.

24. The implant delivery system of any one of claims 22 to 23, further comprising a hole formed through said at least one of said plurality of attachment arms adjacent said free end thereof.

25. The implant delivery system of claim 24, wherein: The hole extends through a thickness of the at least one of the plurality of attachment arms.

26. The implant delivery system of any one of claims 24 to 25, further comprising a retainer configured to slide over the free end of the at least one of the plurality of attachment arms.

27. The implant delivery system of claim 26, wherein: The retainer includes a top side, a bottom side, a first lateral side extending between the top side and the bottom side, and a second lateral side opposite the first lateral side and extending between the top side and the bottom side.

28. The implant delivery system of claim 27, wherein: The top side, the bottom side, the first lateral side, and the second lateral side collectively define a channel extending from a first end to a second end of the retainer, the channel being configured to receive the at least one of the plurality of attachment arms.

29. The implant delivery system of any one of claims 27 to 28, further comprising a first opening in the top side of the retainer and a second opening defined in the bottom side of the retainer, wherein: The first opening has a first diameter and the second opening has a second diameter, the second diameter being greater than the first diameter.

30. The implant delivery system of claim 29, wherein: The first and second openings of the retainer are aligned with the aperture of at least one of the plurality of attachment arms, and the one or more radially extending detents of the proximal head are received within mating recesses formed in a side wall of the first opening of the retainer.

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