Medical implant and implant frame

Abstract

An implant delivery system for delivering an implant to a body. The implant delivery system may comprise 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 comprise a body portion and a plurality of attachment arms extending away from the body portion. At least one soft tissue anchoring portion may be releasably fixable to at least one free end of the plurality of attachment arms and may be configured to releasably fix the implant to the removable frame.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Patent Application No. 63 / 347,737, filed on June 1, 2022, the disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to, but is not limited to, orthopedic implants and methods of treatment. More particularly, the present disclosure relates to systems and methods for delivering tendon repair implants, such as those designed to place an arthroscope across or within an area of a partial or full - 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 damage to the rotator cuff or rotator cuff tendons. Injury to the rotator cuff is a potentially serious medical condition that can occur during acute traumatic lacerations or overuse of the joint, during hyperextension. There is a continuing need to deliver and properly position medical implants during arthroscopic medical procedures to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissues or tendons throughout the body.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] The present disclosure provides, without limitation, alternative means of design, materials, manufacturing methods, and use for implants used for soft - tissue repair such as rotator cuff repair.

Means for Solving the Problems

[0006] One example is an implant delivery system. The implant delivery system includes a delivery shaft having 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 mounting arms extending away from the body portion. At least one soft tissue anchoring portion is releasably secured to the free end of at least one of the plurality of mounting arms. The implant is releasably secured to the frame via at least one soft tissue anchoring portion.

[0007] Additionally or alternatively, in other examples, at least one soft tissue anchoring portion is configured to remain in the body with the implant.

[0008] Additionally or alternatively, in other examples, 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 the implant when the implant is secured to the frame.

[0009] Additionally or alternatively, in other examples, at least one tissue anchoring portion includes a proximal head portion, a distal fixed end, and an intermediate connecting portion extending between the proximal head portion and the distal fixed end.

[0010] Additionally or alternatively, in other examples, the proximal head portion is generally disc-shaped.

[0011] Additionally or alternatively, in other examples, the distal fixed end includes a first catch portion and a second catch portion.

[0012] Additionally or alternatively, in other examples, the intermediate connecting portion includes an elongate bar.

[0013] Additionally or alternatively, in other examples, the proximal head portion is a frustum of a pyramid.

[0014] Additionally or alternatively, in other examples, the distal fixed end has a "U" shape with a catch portion including a first leg portion and a second leg portion.

[0015] Additionally or alternatively, in other examples, the intermediate connecting portion forms a bridge portion between the first leg portion and the second leg portion.

[0016] Additionally or alternatively, in other examples, the system further comprises a recess formed adjacent to the free end in at least one of the plurality of mounting arms.

[0017] Additionally or alternatively, in other examples, the recess extends partially through the thickness of at least one of the plurality of mounting arms to define a thickness reduction region.

[0018] Additionally or alternatively, in other examples, the system further comprises a through hole extending through the thickness reduction region.

[0019] Additionally or alternatively, in other examples, the recess is configured to receive the proximal head portion of at least one soft tissue anchoring portion.

[0020] Additionally or alternatively, in other examples, the intermediate connecting portion extends through a through hole.

[0021] Additionally or alternatively, in other examples, under an applied force, the proximal head portion of at least one soft tissue anchoring portion is configured to be pushed through a thickness reduction region of at least one of the plurality of mounting arms to release the at least one soft tissue anchoring portion from the frame.

[0022] Additionally or alternatively, in other examples, the thickness reduction region is configured to break.

[0023] Additionally or alternatively, in other examples, the thickness reduction region is configured to deform to allow the proximal head portion to pass through the through hole.

[0024] Additionally or alternatively, in other examples, the proximal head portion further comprises one or more radially extending protrusions.

[0025] Additionally or alternatively, in other examples, the system further comprises an opening formed adjacent to its free end through at least one of the plurality of mounting arms.

[0026] Additionally or alternatively, in other examples, the opening extends through the thickness of at least one of the plurality of mounting arms.

[0027] Additionally or alternatively, in other examples, the system further comprises a circumferentially extending groove formed in the side wall of the opening and positioned between a first surface of at least one of the plurality of mounting arms and a second surface of at least one of the plurality of mounting arms.

[0028] Additionally or alternatively, in other examples, the system further comprises at least one axially extending slot formed in the side wall of the opening and extending from a second surface of at least one of the plurality of mounting arms to a circumferentially extending groove.

[0029] Additionally or alternatively, in other examples, during the assembly of at least one soft tissue anchoring portion with at least one of the plurality of mounting arms and during the deployment of at least one soft tissue anchoring portion from at least one of the plurality of mounting arms, one or more radially extending protrusions are configured to slide within at least one axially extending slot.

[0030] Additionally or alternatively, in other examples, one or more radially extending protrusions are rotatably disposed within a circumferentially extending groove during the delivery of the implant to the target site.

[0031] Additionally or alternatively, in other examples, the proximal head portion further comprises one or more radially extending detents.

[0032] Additionally or alternatively, in other examples, the detents extend around the perimeter of the proximal head portion.

[0033] Additionally or alternatively, in other examples, the system further comprises an opening formed adjacent to its free end through at least one of the plurality of mounting arms.

[0034] Additionally or alternatively, in other examples, the opening extends through the thickness of at least one of the plurality of mounting arms.

[0035] Additionally or alternatively, in other examples, the system further comprises a holder configured to slide across the free end of at least one of the plurality of mounting arms.

[0036] Additionally or alternatively, in other examples, the holder comprises an upper side, a lower side, a first lateral side extending between the upper side and the lower side, and a second lateral side opposite the first lateral side extending between the upper side and the lower side.

[0037] Additionally or alternatively, in other examples, the upper side, the lower side, the first lateral side, and the second lateral side collectively define a passage extending from a first end to a second end of the holder, the passage being configured to receive at least one of the plurality of mounting arms.

[0038] Additionally or alternatively, in other examples, the system further comprises a first opening in the upper side of the holder and a second opening defined in the lower side of the holder.

[0039] Additionally or alternatively, in other examples, the first opening has a first diameter and the second opening has a second diameter, the second diameter being larger than the first diameter.

[0040] Additionally or alternatively, in other examples, the first opening and the second opening are generally aligned to define a holder opening extending from the upper side to the lower side.

[0041] Additionally or alternatively, in other examples, the holder opening is aligned with an opening of at least one of the plurality of mounting arms.

[0042] Additionally or alternatively, in other examples, one or more retaining portions extending radially of the proximal head portion are received within mating recesses formed in the sidewalls of the first opening of the retainer.

[0043] Additionally or alternatively, in other examples, the system further comprises an opening formed adjacent to its free end through at least one of the plurality of mounting arms.

[0044] Additionally or alternatively, in other examples, the opening extends through the thickness of at least one of the plurality of mounting arms.

[0045] Additionally or alternatively, in other examples, the system further comprises a retainer configured to slide across the free end of at least one of the plurality of mounting arms.

[0046] Additionally or alternatively, in other examples, the retainer comprises an upper side, a lower side, a first lateral side extending between the upper and lower sides, and a second lateral side opposite the first lateral side and extending between the upper and lower sides.

[0047] Additionally or alternatively, in other examples, the upper side, lower side, first lateral side, and second lateral side collectively define a passage extending from a first end of the retainer to a second end, the passage being configured to receive at least one of the plurality of mounting arms.

[0048] Additionally or alternatively, in other examples, the system further comprises a first opening in the upper side of the retainer and a second opening defined in the lower side of the retainer.

[0049] Additionally or alternatively, in other examples, the first opening and the second opening are generally circular.

[0050] Additionally or alternatively, in other examples, the first opening and the second opening are generally aligned to define a retainer opening extending from the upper side to the lower side.

[0051] Additionally or alternatively, in other examples, the first opening has a first diameter, the second opening has a second diameter, and the second diameter is greater than the first diameter.

[0052] Additionally or alternatively, in other examples, the first diameter of the first opening of the retainer is smaller than the diameter of the proximal head portion of at least one soft tissue anchoring portion.

[0053] Additionally or alternatively, in other examples, the retainer opening is aligned with at least one opening of the plurality of mounting arms.

[0054] Additionally or alternatively, in other examples, the intermediate connecting portion is disposed within the retainer opening and within at least one opening of the plurality of mounting arms, and the lower surface of the proximal head region of at least one soft tissue anchoring portion engages the upper side of the retainer.

[0055] Additionally or alternatively, in other examples, the retainer is configured to break to release at least one soft tissue anchoring portion.

[0056] Additionally or alternatively, in other examples, at least one of the plurality of mounting arms includes a first flexible arm and a second arm adjacent to its free end.

[0057] Additionally or alternatively, in other examples, the first flexible arm and the second flexible arm increase in width towards the free end to define a distal opening having a first width and an opening having a second width greater than the first width.

[0058] Additionally or alternatively, in other examples, the intermediate connecting portion is disposed within the opening.

[0059] Additionally or alternatively, in other examples, the first flexible arm and the second flexible arm are configured to bend away from the longitudinal axis of at least one of the plurality of mounting arms to receive and deploy at least one soft tissue anchoring portion in response to an applied force.

[0060] Additionally or alternatively, in other examples, in the absence of an applied force, the first arm and the second arm are configured to return to an unbiased configuration.

[0061] Additionally or alternatively, in other examples, the first arm and the second arm are configured to engage a recess formed in a sidewall of the proximal head portion.

[0062] Additionally or alternatively, in other examples, the proximal head portion includes an upper side, a lower side, a first lateral side extending between the upper and lower sides, and a second lateral side opposite the first lateral side and extending between the upper and lower sides.

[0063] Additionally or alternatively, in other examples, the upper side, the lower side, the first lateral side, and the second lateral side collectively define a passage extending from a first end to a second end of the proximal head portion, the passage being configured to receive at least one of the plurality of mounting arms.

[0064] Additionally or alternatively, in other examples, the distal fixed end includes a first hook portion and a second hook portion.

[0065] Additionally or alternatively, in other examples, the intermediate connection portion includes a long bar.

[0066] Additionally or alternatively, in other examples, at least one of the plurality of mounting arms includes a first flexible arm and a second flexible arm adjacent to its free end.

[0067] Additionally or alternatively, in other examples, the first flexible arm and the second flexible arm define a gap therebetween.

[0068] Additionally or alternatively, in other examples, each of the first flexible arm and the second flexible arm includes a proximal portion extending generally parallel to a longitudinal axis of at least one of the plurality of mounting arms, and a distal portion terminating at the free end and extending at an angle not parallel to the longitudinal axis of at least one of the plurality of mounting arms.

[0069] Additionally or alternatively, in other examples, each of the free end of the first flexible arm and the free end of the second flexible arm may curve away from the longitudinal axis of at least one of the plurality of mounting arms such that a first width adjacent to the free end of at least one of the plurality of mounting arms is greater than a second width adjacent to the proximal portion of the flexible arm of at least one of the plurality of mounting arms.

[0070] Additionally or alternatively, in other examples, the first flexible arm and the second flexible arm are configured to bend inwardly toward the longitudinal axis of at least one of the plurality of mounting arms under an applied force.

[0071] Additionally or alternatively, in other examples, the first flexible arm and the second flexible arm are configured to bend inwardly to place the first flexible arm and the second flexible arm within a passage of the proximal head portion of at least one soft tissue anchoring portion and to deploy at least one soft tissue anchoring portion from at least one of the plurality of mounting arms.

[0072] Additionally or alternatively, in other examples, at least one of the plurality of mounting arms includes a raised detent extending from its surface adjacent to the free end.

[0073] Additionally or alternatively, in other examples, the raised detent has a distal side and a proximal side.

[0074] Additionally or alternatively, in other examples, the distal side of the raised detent increases in height in the proximal direction.

[0075] Additionally or alternatively, in other examples, the proximal side of the raised detent extends at an angle orthogonal to the surface of at least one of the plurality of mounting arms.

[0076] Additionally or alternatively, in other examples, at least one of the plurality of mounting arms is disposed within a passage of the proximal head portion of at least one soft tissue anchoring portion.

[0077] Additionally or alternatively, in other examples, the raised detent is positioned outside the passage adjacent to the first end of the proximal head portion.

[0078] Additionally or alternatively, in other examples, the raised detent is configured to deform when a lateral tensile force is exerted on the removable frame and to pass at least one of the plurality of mounting arms through the passage of the proximal head portion of at least one soft tissue anchoring portion.

[0079] Additionally or alternatively, in other examples, the proximal head portion further comprises a first detent and a second detent extending from above or below the proximal head portion into the passage.

[0080] Additionally or alternatively, in other examples, at least one of the plurality of mounting arms comprises a first recess and a second recess formed on its surface, the second recess being laterally spaced from the first recess.

[0081] Additionally or alternatively, in other examples, the first detent and the second detent of the proximal head portion are configured to fit with the first recess and the second recess of at least one of the plurality of mounting arms when at least one of the plurality of mounting arms is disposed in the passage of the proximal head portion.

[0082] Additionally or alternatively, in other examples, the first detent and the second detent disengage from the first recess and the second recess when a lateral tensile force is exerted on the removable frame and are configured to pass at least one of the plurality of mounting arms through the passage of the proximal head portion of at least one soft tissue anchoring portion.

[0083] Additionally or alternatively, in other examples, the system further comprises an opening formed adjacent to its free end through at least one of the plurality of mounting arms.

[0084] Additionally or alternatively, in other examples, the aperture extends through the thickness of at least one of the plurality of mounting arms.

[0085] Additionally or alternatively, in other examples, the aperture is generally rectangular.

[0086] Additionally or alternatively, in other examples, the system further comprises a retainer configured to slide across the free end of at least one of the plurality of mounting arms.

[0087] Additionally or alternatively, in other examples, the retainer comprises an upper side, a lower side, a first lateral side extending between the upper and lower sides, and a second lateral side opposite the first lateral side and extending between the upper and lower sides.

[0088] Additionally or alternatively, in other examples, the upper side, the lower side, the first lateral side, and the second lateral side collectively define a passage extending from a first end to a second end of the retainer, the passage being configured to receive at least one of the plurality of mounting arms.

[0089] Additionally or alternatively, in other examples, the system further comprises a first aperture in the upper side of the retainer and a second aperture defined in the lower side of the retainer.

[0090] Additionally or alternatively, in other examples, the first aperture and the second aperture are generally aligned to define a retainer aperture extending from the upper side to the lower side.

[0091] Additionally or alternatively, in other examples, the first aperture has a first width and length, the second aperture has a second width and length, and the second width and length are greater than the first width and length.

[0092] Additionally or alternatively, in other examples, the first width and length of the first aperture of the retainer are less than the width and length of the upper surface of the proximal head portion of at least one soft tissue anchoring portion.

[0093] Additionally or alternatively, in other examples, the retainer opening is aligned with at least one of the openings of the plurality of mounting arms.

[0094] Additionally or alternatively, in other examples, the intermediate connection portion is disposed within the retainer opening and within at least one of the openings of the plurality of mounting arms, and a plurality of sides of the proximal head region of at least one soft tissue anchoring portion engage the upper side of the retainer.

[0095] Additionally or alternatively, in other examples, the retainer is configured to break in order to release at least one soft tissue anchoring portion.

[0096] Additionally or alternatively, in other examples, the retainer is configured to bend in order to release at least one soft tissue anchoring portion.

[0097] The above summaries of some embodiments are not intended to describe each disclosed embodiment, or every implementation of the present disclosure. The figures and detailed description that follow more specifically illustrate these embodiments.

[0098] The present disclosure may be more fully understood in consideration of the following detailed description in connection with the accompanying drawings.

Brief Description of the Drawings

[0099]

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[0100] The present disclosure is capable of accepting various changes and alternative forms, and details thereof are shown and described in detail by way of examples in the drawings. However, it should be understood that the intention is not to limit the present disclosure to the specific embodiments described. On the contrary, the intention is to cover all changes, equivalents, and alternatives within the spirit and scope of the present disclosure.

[0101] For the following defined terms, these definitions apply where different definitions are not provided elsewhere in the claims or in this specification.

[0102] All numerical values are assumed herein to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result). In many instances, the term "about" may include numbers rounded to the nearest significant digit.

[0103] The recitation of a range of numbers by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0104] 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 the sense including “and / or” unless the content clearly dictates otherwise.

[0105] It is noted that references in this specification to “embodiments,” “certain embodiments,” “other embodiments,” etc. indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such recitation does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Also, when a specific feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may be used in connection with other embodiments whether or not explicitly described, unless clearly stated to the contrary.

[0106] The following detailed description should be read with reference to the drawings in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict exemplary embodiments and are not intended to limit the scope of the present disclosure.

[0107] Due to their complexity, range of motion, and widespread use, common soft tissue injuries are injuries to the rotator cuff or rotator cuff tendons. Injuries to the rotator cuff are potentially serious medical conditions that can occur during hyperextension from acute traumatic lacerations or overuse of the joint. Current rehabilitative medical treatments attempt to reduce impingement or create room for tendon movement to prevent further injury and reduce discomfort, but do not repair or strengthen the tendon. Recognized treatments for rotator cuff lacerations can include reattaching the torn tendon to the head of the humerus using sutures. Also, when treating a rotator cuff laceration, recognized practices can include placement of a scaffold across the repaired tendon to mechanically reinforce the repaired tendon. Therefore, there is a continuing need to deliver and properly position medical implants during arthroscopic medical procedures to treat rotator cuff, rotator cuff tendon, or other soft tissue or tendon injuries throughout the body.

[0108] FIG. 1 shows a cross-sectional view of a shoulder 10 including an exemplary implant 12. Shoulder 10 further shows a head 14 of a humerus 16 that fits into a glenoid fossa 18 of a scapula 20. Glenoid fossa 18 comprises a shallow depression in scapula 20. A supraspinatus tendon 22 is also shown. These muscles control (among other things) the movement of humerus 16 relative to scapula 20. A distal tendon 24 of supraspinatus tendon 22 contacts humerus 16 at an insertion point 26.

[0109] In FIG. 1, distal tendon 24 includes an injured portion 28 positioned near insertion point 26. Injured portion 28 includes a laceration 30 that extends partially through distal tendon 24. Laceration 30 can also be referred to as a partial-thickness laceration. The depicted partial-thickness laceration 30 is on the bursal side of the tendon, but the laceration can be on the opposite or joint side of distal tendon 24 and / or can include an internal laceration to distal tendon 24 that is not visible on either surface. In other examples, laceration 30 can be a full-thickness laceration.

[0110] FIG. 1 further shows that the tendon repair implant 12 is disposed across a partial thickness tear 30. In this example, the tendon repair implant 12 is disposed on the bursal side of the tendon, regardless of whether the tear is on the bursal side, the articular side, or within the tendon itself. Further, the tendon repair implant 12 may overlap multiple tears.

[0111] One possible treatment site is depicted in the figure as being located in the shoulder joint, but the implant 12 can be used at various different treatment sites, such as the hip joint, knee joint, ankle joint, etc. Further, the implant 12 can be used for any of a variety of soft tissue repairs, including but not limited to the gluteus medius, a large fan-shaped muscle located on the posterior hip, and the hip joint capsule, also in the hip joint. The implant 12 can be used for treating soft tissue injuries in the knee, including but not limited to ligaments such as the ACL (anterior cruciate ligament), MCL (medial collateral ligament), and PCL (posterior cruciate ligament), as well as tendons such as the hamstring tendon, quadriceps tendon, and patellar tendon. The implant 12 can be used for treating soft tissue injuries in the Achilles tendon. The implant 12 can be used for treating soft tissue injuries in any area of the body that houses the implant 12.

[0112] In some examples, delivery of the implant 12 (e.g., a sheet-like implant) to the target site of a patient may require the physician to create an incision in the patient that is sufficient to access the target implant site. After creating this “access site,” the physician can insert a delivery system for the implant through the access site and position the distal end of the implant delivery system adjacent to the target implant site. Next, the physician can operate the implant delivery system to deploy the implant from the delivery sheath adjacent to the target implant site.

[0113] For example, FIG. 2 provides a perspective view of an implant delivery system 40 extending through a patient's shoulder 10. FIG. 2 shows the implant delivery system 40 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) having a proximal portion (not shown), a distal portion 48, and a lumen extending through at least a portion of itself. Further, the implant delivery system 40 may include a delivery shaft 44 extending through the lumen of the sheath member 42 and movable longitudinally relative to the sheath member 42.

[0114] The delivery shaft 44 may include a proximal portion (not shown) that extends out of the proximal portion of the sheath member 42 and / or is operable by a user relative to the sheath member 42. Also, in some examples, the proximal portion of the delivery shaft 44 and / or the sheath member 42 may be coupled to a handle member (not shown). The handle member can be utilized to manipulate the delivery shaft 44. For example, the handle member may be utilized to apply a rotational force to the delivery shaft 44.

[0115] Also, the delivery shaft 44 may include a distal portion 50 that extends out of the distal portion 48 of the sheath member 42. Further, the delivery shaft 44 may include a lumen extending therethrough. The lumen of the delivery shaft 44 may 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).

[0116] Delivery system 40 may further include a removable frame member 46 attached to the distal portion 50 of delivery shaft 44, which in some examples may be removable from delivery shaft 44. As shown in FIG. 2, removable frame 46 can be attached to implant 12 (e.g., a sheet-like implant) for delivery to the implantation site and subsequent placement at the implantation site. For the purposes of the discussion herein, the combined structure including frame 46 and implant 12 may be defined as having a proximal end 52 and a distal end 54, as shown in FIG. 2.

[0117] When initially positioning frame 46 and implant 12 adjacent to the target site, the clinician can orient frame 46 and implant 12 (e.g., via a handle member attached to the proximal portion of delivery shaft 44) such that the distal portion 54 (i.e., the inner portion) of frame 46 and implant 12 can overlap the distal tendon 24, while the proximal portion 52 (i.e., the outer portion) can be adjacent to (e.g., overlap) a portion of the humerus bone.

[0118] As previously described, delivery of implant delivery system 40 can include insertion of delivery sheath 42 through an access site (e.g., an incision) and advancement to the target site. After positioning the distal end 48 of delivery sheath 42 adjacent to the target region, the clinician can retract delivery sheath 42 relative to delivery shaft 44 and frame 46 and position removable frame 46, in combination with implant 12, outside of the lumen positioned along distal portion 48 within the distal portion 48 of delivery sheath 42.

[0119] Prior to deployment, the combination of the removable frame 46 and the implant 12 can be included (e.g., contained) within the lumen of the delivery sheath 42 for subsequent distal deployment from the distal opening of the delivery sheath 42. The combination of the removable frame 46 and the implant 12 can wrap around and / or fold upon itself so as to be positioned within the lumen of the delivery sheath 42. Alternatively, the removable frame 46 and the implant 12 can wrap around and / or fold around the implant delivery shaft 44 while being disposed within the delivery sheath 42.

[0120] In some cases, the removable frame 46 can be formed as a single structure from a single piece of material (e.g., machined, cut, shaped, punched, laser cut, etc.) so as to be formed as an integral structure. It is contemplated that the removable frame 46 can be constructed using alternative materials and / or manufacturing methods. For example, the frame 46 or a portion thereof can be constructed from a polymer material, a ceramic material, and / or various other materials. Also, the frame 46 can be manufactured via injection molding or alternative polymer manufacturing methods. Alternatively, the frame 46 can be formed through a 3D printing process, if desired. Further, different portions of the frame 46 may be made from different materials and may be combined using alternative methods. Variations combining different materials for different portions of the frame 46 are contemplated.

[0121] For purposes of simplicity, when combined with the implant 12 of the example, the frame 46 can be defined as having a first surface that faces away from the implant 12 when the implant 12 is attached to the frame 46 (e.g., a first surface that faces away from the target site in the body), and a second surface that faces the implant 12 of the example (e.g., a second surface that faces the target site in the body). In some examples, the attachment opening 70 can extend from the first surface to the second surface. Stated another way, in some examples, the attachment opening 70 can be defined as a hole and / or opening that extends through the thickness of the frame 46 from a first surface of the frame 46 that faces away from the implant 12 to a second surface of the frame 46 that faces the implant 12.

[0122] The attachment opening 70 can be utilized to attach and / or couple the frame 46 to the implant 12 of the example. FIG. 3A shows an example frame 46 attached to an example implant 12. Further, FIG. 3 shows an example frame 46 attached to an example implant 12 at the distal or free end of each of the four attachment arms 64. The attachment of the free distal end of the attachment arm 64 to the implant 12 can be performed by any desired attachment mechanism.

[0123] FIG. 3B shows a detailed view of a portion of the proximal portion 52 of the frame 46 attached to the implant 12. Further, FIG. 3B shows an example attachment arm 64 that includes a distal portion 68. Three attachment openings 70 are positioned along the distal portion 68 of the attachment arm 64. Also, FIG. 3B shows an example attachment member (e.g., a wire) 76 that extends through one or more of the attachment openings 70 positioned in the distal portion 68 of the attachment arm 64.

[0124] The attachment member 76 can be one of several structures and / or techniques contemplated for attaching the exemplary frame 46 to the exemplary implant 12. As shown in FIG. 3B, the attachment member 76 can be positioned, looped, wound, and / or screwed through one or more attachment openings 70 so as to be prevented from being pulled away from the distal portion 68 of the attachment arm 64. In other words, winding the attachment member 76 through one or more of the attachment openings 70 can effectively secure the attachment member 76 to the attachment arm 64. In other words, it is contemplated that the attachment member 76 can be secured to the distal portion 68 of the attachment arm 64 (e.g., via the attachment openings 70) without directly attaching either end of the attachment member 76 to any structure (e.g., the frame 46) (e.g., welding, coupling, etc.). In some examples, the attachment member 76 can be wound and / or looped one or more times through the attachment openings 70 to provide a friction fit and / or a resistant tension against unwinding or loosening when a pulling force is applied to the attachment member 76. In other examples, the implant may be attached to the attachment arm 64 in other manners, such as other attachment members attached to the attachment arm 64 and / or other attachment members extending from the attachment arm 64.

[0125] FIG. 3B shows a single attachment member 76 extending between two attachment openings 70, but it is contemplated that the attachment member 76 can extend and / or be wound between two or more of the attachment openings 70. For example, it is contemplated that the attachment member 76 may be woven through three openings 70 (e.g., above and below the three openings 70) to lock the attachment member 76 to the distal end 68 of the attachment arm 64.

[0126] The above discussion and the foregoing examples are not intended to limit the present disclosure to the use of attachment members (e.g., wires, threads, 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 other attachment mechanisms, to attach the frame 46 to the implant 12. Also, various injection molding techniques may be used to attach the frame 46 to the implant 12. Further, combinations 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 the need to wrap the attachment member 76 through the attachment opening 70.

[0127] As previously described, in the examples contemplated herein, it has been contemplated that the frame 46 be "removable" from the implant 12. For example, the frame 46 may be configured to be removable from the implant 12 after the implant 12 has been secured to the target site in the body. Thus, in some of the examples disclosed herein, it is understandable that the frame member 46 may be temporarily attached to the implant 12. For example, while the frame member 46 can be connected, secured, or attached to the implant 12, it can be positioned within the delivery sheath 42, deployed out of the delivery sheath 42, and manipulated to a predetermined position relative to the target site. (e.g., along the tendon and / or the head of the humerus) Once positioned at the target site, the implant 12 can be secured to the target site via a bioadhesive, tissue anchor, and / or suture. However, once the implant 12 is secured to the target site, the frame 46 can be pulled away (e.g., removed) from the frame 12 and removed from the body. As will be described in more detail herein, in some cases, the implant 12 may be releasably coupled to the frame 46 via one or more tissue anchors, and the one or more tissue anchors are also utilized to secure the implant 12 to the tissue at the target site and then released from the frame 46 so as to remain at the target site with the implant at the completion of the medical procedure.

[0128] FIG. 3B shows an example mounting configuration that allows the frame 46 to be removed from the implant 12. FIG. 3B shows a mounting member 76 wrapped in a helical pattern 80 along the surface of the implant 12 facing the target site. In other words, the mounting member 76 can form a helical pattern 80 that lies in a plane substantially parallel to the plane of the surface of the implant 12 facing the target site. Further, the mounting member 76 can extend through the combined thickness of the mounting arm 64 and the implant 12 from the side of the mounting arm 64 that faces away from the implant 12 and can ultimately exit the implant 12 at the surface of the implant 12 facing the target site. Further, it can be understood that the helical pattern 80 shown in FIG. 3B is one of various configurations in which the mounting member 76 can be wrapped to prevent the frame 46 from being prematurely released from the implant 12.

[0129] The mounting member 76 may have a first end fixed to the free distal end of the mounting arm 64 positioned on a first side of the implant 12 and a second end positioned on a second opposite side of the implant 12. In some examples, the mounting member 76 can extend through the implant 12 from a first side of the implant 12 to a second side of the implant 12. However, in other examples, the mounting member 76 may extend around the edge of the implant 12 from a first side of the implant 12 to a second side of the implant 12.

[0130] In some cases, the attachment member 76 can be configured to be removed from the implant 12 when a threshold level of force is applied. For example, the helical pattern 80 shown in FIG. 3B can provide the frame 46 with the ability to be removed from the implant 12 when a threshold of "pull-off force" is applied to the frame 46. For example, after the implant 12 is fixed to the target site, the clinician can apply a force (e.g., via a tether) to the frame 46 such that the frame 46 is pulled away from the implant 12. On the condition that the force is large enough (e.g., the threshold force is met), the attachment member 76 (e.g., the helical portion 80 of the attachment member 76 shown in FIG. 3B) is 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, on the condition that a threshold pull-off force is applied to the frame 46, the attachment member 76 forming the helix 80 shown in FIG. 3B can be loosened and pulled back through the implant 12.

[0131] FIG. 3C shows another example method for attaching the frame 46 to the exemplary implant 12. As shown in FIG. 3C, the attachment member 76 can include a helix 81 (similar to the helix 80 shown in FIG. 3B) positioned on the surface of the implant 12 facing away from the target site. Also, FIG. 3C shows that the attachment member 76 can include a second helix 82 positioned on the surface of the attachment arm 68 facing away from the implant 12. In other words, FIG. 3C shows two helices 81 / 82 positioned on both the attachment arm 64 (e.g., helix 82 in FIG. 3C) formed at the opposite end of the attachment member 76 and facing away from the implant 12 and the side of the implant 12 located along the treatment site (e.g., helix 81 in FIG. 3C). The configuration of the helices 81 / 82 can provide the frame 46 with a "releasable" connection to the implant 12 similar to that discussed with respect to FIG. 3B.

[0132] Figure 4 shows a frame 46 of an example coupled to an implant 12 of an example via an attachment member 76 as described previously. Further, Figure 4 shows a frame 46 combined with an implant 12 coupled to an implant delivery system 40 of an example. Similar to what was considered with respect to Figure 2, the implant delivery system 40 includes an implant delivery shaft 44 that extends through a lumen 84 of a delivery sheath 42 of an example.

[0133] Further, Figure 4 shows a delivery shaft 44 coupled to the frame 46 via a connection assembly 88. The connection assembly 88 can include a first connection member 90 attached to a head portion 58 of the frame 46 and a second connection member 92 attached to a distal end 50 of the delivery shaft 44. Although Figure 4 does not directly show the first connection member 90 attached directly to the second connection member 92, it can be understood that the first connection member 90 and the second connection member 92 of the connection assembly 88 can form a matching connection. For example, in some examples, the first connection member 90 can form a male connection member, while the second connection member 92 can form a mating female connection member. Stated another way, in one example, the second connection member 92 can include a cavity configured to overlie and extend over the first connection member 90 and allow the first connection member 90 to be inserted therein. In other examples, the first connection member 90 can be a female connection member, while the second connection member 92 can be a mating male connection member.

[0134] Also, as shown in FIG. 4, it is being considered that the second connecting member 92 can be disengaged or disconnected from the first connecting member 90. For example, in some examples, the connection assembly 88 (including the first connecting member 90 and the second connecting member 92) can be defined as a "quick release type" connection assembly or a disconnectable connection assembly. It is further being considered that various designed configurations can be used to engage / disengage (i.e., connect / disconnect) the first connecting member 90 and the second connecting member 92 from each other. For example, the first connecting member 90 and the second connecting member 92 may be connected via screw connection, friction fitting, connection by spring load, bayonet connection, movable ring portion, or other operating mechanisms. Further, the connecting members 90, 92 may be engaged / disengaged by the operator of the device.

[0135] In some examples, the delivery shaft 44 may be attached to the head portion 58 of the frame member 46 (e.g., via the connection assembly 88). As shown in FIG. 4, the first connecting member 90 of the connection assembly 88 can be attached to the head portion 58 via an opening 60 (not shown). In some examples, the first connecting member 90 can be attached to the head portion 58 of the frame member 46 via various mechanical fastening means (e.g., injection molding, encapsulation, bonding, etc.).

[0136] As previously discussed, in some examples, a physician 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 implantation site (e.g., a torn tendon). Adjacent to the target site, the physician can manipulate the implant delivery shaft 44 to advance the implant 12 (while attached to the removable frame 46) from the delivery sheath 42 adjacent to the target implantation site. For example, the physician can retract the delivery sheath 42 proximally relative to the delivery shaft 44 and the frame 46 and / or advance the delivery shaft 44 and the frame 46 distally relative to the delivery sheath 42.

[0137] FIG. 4 shows the frame 46 and the implant 12 deployed from the distal portion 48 of the delivery sheath 42. In some examples, the frame 46 and the implant 12 can have a substantially concave shape relative to the delivery sheath 42. It can be understood that the concave shape of the frame member 46 and the implant 12 can facilitate positioning the implant 12 along the generally rounded shape of the head of the humerus in a person's shoulder.

[0138] However, when positioned within the delivery sheath 42 (e.g., prior to deployment), the frame 46 and the implant 12 can be wrapped around the delivery shaft 44 in a convex configuration. Thus, the frame 46 and the implant 12 can change 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 when advanced from the sheath 42 (e.g., when deployed).

[0139] Stated another way, the frame 46 and the implant 12 can be attached to the delivery shaft 44 via the connection assembly 88 when positioned within the lumen 84 of the delivery sheath 42. In one example, when positioned within the delivery sheath 42, the frame 46 and the implant 12 can be wound around the delivery shaft 44 or can extend around the delivery shaft 44. The position of the frame 46 and the implant 12 can be in a convex configuration relative to the distal end 50 of the delivery shaft 44. The frame 46 and the implant 12 can "change" from a convex configuration to a concave configuration (when viewed with respect to the distal end 50 of the delivery shaft 44) when deployed from the distal end 50 of the delivery shaft 44. Additional details regarding the frame 46 and implant delivery system 40 can be found in Patent Document 1, which is hereby incorporated by reference in its entirety.

[0140] The frame 46 and the implant 12 described previously may require the delivery system 40 to deploy the tendon anchor and the bone anchor and subsequently position the implant 12 at the desired location by a separate delivery system to fix the implant 12 to the underlying tendon tissue and bone, respectively. In some cases, the soft tissue anchors can be delivered one at a time using an anchor inserter that requires the user to reattach each individual soft tissue anchor outside of the arthroscopic space. Thereby, the anchor inserter can be inserted into the patient's shoulder (or other implantation site) up to and including eight times, or up to the number of soft tissue anchors, and removed from the patient's shoulder. The bone anchors may be deployed in a similar manner to the soft tissue anchors by individual disposable punches required per deployment of the bone anchor. It is contemplated that the soft tissue anchors may be pre-assembled with the implant and / or the frame 46 to reduce the number of treatment steps and / or to reduce the requirements for the size of the portal / incision.

[0141] FIG. 5 shows another example of a frame member 100 configured to be releasably attached to the implant 12. The frame 100 can be configured to be delivered to a target location in the body in a manner similar to the techniques described previously with respect to frame 46. For purposes of the discussion herein, the combined structure including the frame 100 and the implant 12 can be defined as having a proximal end 102 (i.e., outer end) and a distal end 104 (i.e., inner end). When initially positioning the frame 100 and the implant 12 adjacent to the target site, the clinician can orient the frame 100 and the implant 12 such that the distal portion 104 (i.e., inner end) of the frame 100 and the implant 12 can overlap the tendon, while the proximal portion 102 (i.e., outer end) can be adjacent to (e.g., overlap) a portion of the humerus bone (e.g., to the bone), for example, via a gripping member attached to the proximal portion of the delivery shaft.

[0142] Prior to deployment, the combination of the removable frame 100 and the implant 12 can be included (e.g., housed) within the lumen of the delivery sheath for subsequent distal deployment from the distal opening of the delivery sheath. The combination of the removable frame 100 and the implant 12 can wrap around and / or fold upon itself to be positioned within the lumen of the delivery sheath. Alternatively, the removable frame 100 and the implant 12 can wrap around and / or fold around the implant delivery shaft while being disposed within the delivery sheath.

[0143] In some cases, the removable frame 100 can be formed as a single structure from a single piece of material (e.g., machined, cut, shaped, punched, laser cut, etc.) to form an integral structure. It is contemplated 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 polymer materials, ceramic materials, and / or various other materials. Also, the frame 100 can be manufactured via injection molding or alternative polymer manufacturing methods. Alternatively, the frame 100 can be formed through a 3D printing process, if desired. Further, different portions of the frame 100 may be made from various materials and may be combined using alternative methods. Variations of combining different materials with different portions of the frame 100 are contemplated.

[0144] For the purpose of simplicity, when combined with the implant 12, the frame 100 can be defined as having a first surface 106 that faces away from the implant 12 when the implant 12 is attached to the frame 100 (e.g., a first surface that faces away from the target site in the body), and a second surface 108 that faces the implant 12 or is juxtaposed with the implant 12 (e.g., a second surface that faces the target site in the body) (see, e.g., FIG. 6B). The frame 100 can include a plurality of mounting arms 110a, 110b, 110c, 110d, 110e, 110f (collectively, 110) that extend away from the body portion 112. Although the frame 100 is shown as including six mounting arms 110, it is contemplated that the frame 100 may include fewer than six (e.g., one, two, three, four, or five) or more than six (e.g., seven, eight, or more) mounting arms 110, as desired. In some examples, the number of mounting arms 110 may be correlated with the number of tissue anchors used to secure the implant 12, as described in more detail herein. The soft tissue anchors 120a, 120b, 120c, 120d, 120e, 120f (collectively, 120) may be positioned adjacent to one or more distal or free ends of the mounting arms 110. In some embodiments, each mounting arm 110 may include a soft tissue anchor 120. However, this is not essential. In some examples, not all of the mounting arms 110 necessarily include a soft tissue anchor 120. For example, some mounting arms 110 may not have a tissue anchor or other attachment mechanism, or may include an attachment mechanism configured to remain with the frame 100, such as those described in Patent Document 1, which is incorporated herein by reference in its entirety. In some examples, each of the mounting arms 110b, 110c, 110d, and 110e that overlap soft tissue (e.g., a tendon) includes a soft tissue anchor 120, while each of the mounting arms 110a, 110f that overlap bone (e.g., the head of the humerus) utilizes an attachment mechanism configured to remain with the frame 100, as described above.

[0145] The soft tissue anchoring portion 120 may be utilized to attach and / or couple the frame 100 to the exemplary implant 12 during delivery of the implant 12 to the treatment site. In some cases, the soft tissue anchoring portion 120 may also be able to anchor the implant 12 to body tissue when positioned at the treatment site. For example, the soft tissue anchoring portion 120 or a portion thereof may fix the implant 12 to soft tissue (e.g., tendon), and may remain in the body with the implant 12 after the frame 100 is removed from the treatment site. FIG. 5 shows an exemplary frame 100 attached to an exemplary implant 12. Further, FIG. 5 shows an exemplary frame 100 attached to an exemplary implant 12 at the distal end or free end of each of the six attachment arms 110. The attachment of the free distal end of the attachment arm 110 to the implant 12 can be performed by any desired attachment mechanism.

[0146] FIG. 6A is a detailed view of an exemplary soft tissue anchoring portion 120a assembled with the frame 100 and the implant 12. FIG. 6B is a cross-sectional view of the exemplary soft tissue anchoring portion 120a and the attachment arm 110a taken along line 6B-6B of FIG. 6A. Although the soft tissue anchoring portion 120a is described in relation to a particular attachment arm 110a, it should be understood that the soft tissue anchoring portion 120a may be provided on any of the attachment arms 110 as desired. The soft tissue anchoring portion 120a may include a proximal head portion 122 configured to hold down the implant 12, and a distal fixation end 124 configured to pierce the tissue. An elongated intermediate connection portion or body 126 may extend between the proximal head portion 122 and the distal fixation end 124. It is contemplated that the proximal head portion 122 may be a generally planar component having a width greater than the width of the intermediate connection portion or body 126. In some cases, the proximal head portion 122 may generally be in the form of a disc having a generally circular cross-section. However, this is not essential. The proximal head portion 122 may have other cross-sectional shapes, such as, but not limited to, square, rectangular, elliptical, polygonal, etc.

[0147] The distal fixation end 124 may generally be in a “V” shape, or may have a sharp tip, and may include a first engaging portion 128a and a second engaging portion 128b (collectively, 128). The distal fixation end 124 may be shaped such that when the distal fixation end 124 is assembled with the frame 100 and / or body tissue, proximal retraction of the soft tissue anchoring portion 120a is prevented or impeded. For example, each of the engaging portions 128 may include proximal ends 130a, 130b (collectively, 130) radially spaced from the intermediate connecting portion or body 126, and distal ends 132a, 132b in contact with or connected to the distal fixation end 124. In some cases, fewer than two or more engaging portions 128 may be provided. In some cases, the proximal ends 130 of the engaging portions 128 may be configured to distort radially inward to facilitate distal advancement of the soft tissue anchoring portion 120a through the frame 100, the implant 12, and / or body tissue, and to return to a configuration that extends outwardly after expansion (such as the configuration shown in FIG. 6B), but this is not essential. The distal fixation end or distal tip of the soft tissue anchoring portion 120a is configured to lead the soft tissue anchoring portion 120a when advanced into the body tissue. The engaging portions 128 are angled or inclined such that the soft tissue anchoring portion 120a can be easily advanced distally through the tissue, but proximal retraction of the soft tissue anchoring portion 120a is difficult or impossible. This can help ensure that the soft tissue anchoring portion 120a self-anchors when assembled with the frame 100 and / or implant 12 and / or implanted into the tissue. The angle and / or length of the engaging portions 128 may be varied. It is contemplated that the engaging portions 128 may have a structure or shape different from an angled surface, including, but not limited to, curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 128 may be used to help fix the soft tissue anchoring portion 120a to the frame 100 and implant 12 and / or within the tissue.

[0148] The intermediate connection portion or body portion 126 can be an elongated shaft generally having a cylindrical shape, but can take other shapes as desired. The intermediate connection portion or body portion 126 is shown as generally having a uniform cross-sectional dimension, but it is contemplated that the cross-sectional dimension of the intermediate connection portion or body portion 126 may vary along its length. For example, the intermediate connection portion or body portion 126 may have a reduced cross-sectional dimension from the proximal head portion 122 towards the distal fixed end 124. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 120a may be formed as a single integral structure or as a series of components fixed to each other as desired.

[0149] It is further contemplated that the soft tissue anchoring portion 120a can take other configurations. For example, the soft tissue anchoring portion 120a can be a "U"-shaped tissue anchoring portion with a hook, similar to the needle of a stapler, having two legs extending distally. In such an example, the hooked edge or legs pierce the tissue and are fixed within the tissue, while the "U" shaped connection portion or bridge portion provides support for holding the implant 12 between the hooked legs. In other cases, the soft tissue anchoring portion 120a can be a screw having a threaded body portion. The threaded region can pierce the tissue while the head of the screw provides support for holding the implant 12. These are merely some examples.

[0150] The attachment arm 110a may include a recess 114a for receiving therein the proximal head portion 122. For example, the recess 114a may be a generally circular recess configured to receive the circular proximal head portion 122 of the soft tissue anchor 120. However, the recess 114a can 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 a region 118a of the attachment arm 110a having a reduced thickness. The recess 114a can be sized and shaped to receive the proximal head portion 122 of the soft tissue anchor 120a. The proximal head portion 122 of the soft tissue anchor 120a can be fitted or inserted into the recess 114a. For example, the recess 114a can be deep enough such that the proximal head portion 122 is flush with or lower than the first surface 106 of the frame 100 (e.g., the surface facing away from the implant 12). This can help reduce the profile of the frame 100 during delivery. However, this is not essential. In some cases, the proximal head portion 122 of the soft tissue anchor 120a can extend above or beyond the first surface 106 of the frame 100.

[0151] In some cases, the through-hole or opening 140a may be formed through the thickness reduction region 118a. The through-hole 140a may be sized and shaped to receive the intermediate connection portion 126 and allow the distal fixation end 124 to pass through the through-hole 140a and beyond the lower side 108 of the frame 100. In some embodiments, the through-hole 140a may be pre-formed in the attachment arm 110a. In other embodiments, the through-hole 140a may be formed when the soft tissue anchoring portion 120a is assembled with the attachment arm 110a. For example, the thickness reduction region 118a may be configured to rupture or break when the distal fixation end 124 is pushed through the thickness reduction region 118a. The soft tissue anchoring portion 120a is assembled with the attachment arm 110a such that the implant 12 is connected to the frame 100, such as between the lower side 108 of the frame and the distal tip with the engaging portion of the soft tissue anchoring portion 120a as shown in FIGS. 5 and 6A-6B. It is contemplated that the implant 12 may be positioned along the frame 100 such that the distal fixation end 124 pierces and penetrates through the implant 12.

[0152] Frame 100, implant 12, and soft tissue anchoring portion 120a can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using, for example, a bone tack associated with the delivery frame 100 of the delivery device when positioned at the target location. The delivery shaft of the delivery device can be released from the frame 100 and retracted from the portal to insert other devices. In some cases, a tether may be connected to the frame 100 and can extend outside the body to facilitate retrieval of the frame 100 when the frame 100 is disconnected from the implant 12. Next, an instrument can be advanced to disconnect the soft tissue anchoring portion 120a from the frame 100. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 122 of the soft tissue anchoring portion 120a. Next, a force can be exerted on the proximal head portion 122 by the instrument to advance the soft tissue anchoring portion 120a distally such that the distal fixed end 124 pierces and penetrates the tissue. It is contemplated that the thickness reduction region 118a of the attachment arm 110a can be configured to be prone to cracking such that when a force is exerted on the proximal head portion 122 to pass the proximal head portion 122 through the through-hole or opening 140a, the thickness reduction region 118a breaks away from the attachment arm 110a. In some cases, the thickness reduction region 118a may break away entirely and remain in the body with the soft tissue anchoring portion 120a and implant 12. In other cases, the thickness reduction region 118a may be configured to deform when the proximal head portion 122 passes through the through-hole or opening 140a such that the thickness reduction region 118a remains connected to the attachment arm 110a. The instrument can be repositioned to align the implant 12 with other soft tissue anchoring portions 120 that connect to the frame 100, and a force can be exerted on the soft tissue anchoring portion 120 by the instrument to disconnect additional soft tissue anchoring portions 120 from the frame 100 and penetrate underlying body tissue (e.g., tendon). This can be repeated for each soft tissue anchoring portion 120 provided with the frame 100.This allows a clinician to deploy multiple soft tissue anchoring portions 120 without having to individually attach each soft tissue anchoring portion 120 to the instrument and without having to repeatedly insert and remove the instrument in an incision to access the treatment site.

[0153] FIG. 7A shows an exploded perspective view of an exemplary mounting arm 210 and soft tissue anchoring portion 220 of the frame 200. The frame 200 may be similar in form and function to the frame 100 described herein. The soft tissue anchoring portion 220 may 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. FIG. 7B is a cross-sectional view of the exemplary mounting arm 210 taken along line 7B-7B of FIG. 7A. FIG. 7C is a top view of the soft tissue anchoring portion 220 assembled with the exemplary mounting arm 210. Although the soft tissue anchoring portion 220 is described in relation to a single mounting arm 210, it should be understood that the soft tissue anchoring portion 220 may be provided on any number of mounting arms 210 as desired.

[0154] The soft tissue tether 220 may include a proximal head portion 222 configured to hold down the implant 12 and a distal fixation end 224 configured to pierce into the tissue. An elongated intermediate connecting portion or body 226 may extend between the proximal head portion 222 and the distal fixation end 224. It has been contemplated that the proximal head portion 222 may be a generally planar component having a width greater than the width of the intermediate connecting portion or body 226. In some cases, the proximal head portion 222 may be generally disc-shaped having a generally circular cross-section. However, this is not essential. The proximal head portion 222 may have other cross-sectional shapes, such as, but not limited to, square, rectangular, elliptical, polygonal, etc. The proximal head portion 222 may include one or more radially extending protrusions 234a, 234b (collectively, 234) extending from its outer periphery, the protrusions 234 defining a region of the proximal head portion 222 having a cross-sectional dimension 238 that is greater than the cross-sectional dimension 236 of the proximal head portion without the protrusions 234. The protrusions 234 may be sized and shaped to mate with corresponding slots and / or grooves in the attachment arm 210, as will be described in more detail herein. In some examples, the one or more protrusions 234 may be arranged spirally around the proximal head portion 222 like a male thread.

[0155] The distal fixation end 224 may generally be in a “V” shape, or may have a sharp tip, and may include a first engaging portion 228a and a second engaging portion 228b (collectively, 228). The distal fixation end 224 may be shaped such that when the distal fixation end 224 is assembled with the frame 200 and / or body tissue, proximal retraction of the soft tissue anchoring portion 220 is prevented or obstructed. For example, each of the engaging portions 228 may include proximal ends 230a, 230b (collectively, 230) radially spaced from the intermediate connecting portion or body 226, and distal ends 232a, 232b (collectively, 232) in contact with or connected to the distal fixation end 224. In some cases, fewer than two or more engaging portions 228 may be provided. In some cases, the proximal ends 230 of the engaging portions 228 may be configured to distort radially inward to facilitate distal advancement of the soft tissue anchoring portion 220 through the frame 200, implant 12, and / or body tissue, and to return to a configuration that extends outwardly after insertion and expands (such as the configuration shown in FIG. 7A), although this is not essential. The distal fixation end or distal tip of the soft tissue anchoring portion 220 is configured to guide the soft tissue anchoring portion 220 when advanced into the body tissue. The engaging portions 228 are angled or inclined such that the soft tissue anchoring portion 220 can be easily advanced distally through the tissue, but proximal retraction of the soft tissue anchoring portion 220 is difficult or impossible. This can help ensure that the soft tissue anchoring portion 220 self-anchors when assembled with the frame 200 and / or implant 12 and / or implanted into the tissue. The angle and / or length of the engaging portions 228 may be varied. It is contemplated that the engaging portions 228 may have a structure or shape different from the angled surface, including but not limited to curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 228 may be used to help fix the soft tissue anchoring portion 220 to the frame 200 and implant 12 and / or within the tissue.

[0156] The intermediate connection portion or body 226 can be an elongated bar generally having a cylindrical shape, but can take other shapes as desired. The intermediate connection portion or body 226 is shown as generally having a uniform cross-sectional dimension, but it is contemplated that the cross-sectional dimension of the intermediate connection portion or body 226 may vary along its length. For example, the intermediate connection portion or body 226 may have a reduced cross-sectional dimension from the proximal head portion 222 toward the distal fixed end 224. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 220 may be formed as a single integral structure, or as a series of components fixed to each other, as desired.

[0157] It is further contemplated that the soft tissue anchoring portion 220 can take other configurations. For example, the soft tissue anchoring portion 220 may be a screw having a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for holding down the implant. This is merely an example.

[0158] The attachment arm 210 can include a generally circular opening 214 configured to receive the proximal head portion 222 of the soft tissue anchoring portion 220. The opening 214 extends through the thickness of the attachment arm 210 from a first surface 206 (e.g., a first surface facing away from the implant 12 when the implant 12 is attached to the frame 200, such as a first surface facing away from the target site in the body) to a second surface 208 facing or juxtaposed to the exemplary implant 12 (e.g., a second surface facing the target site in the body). The opening 214 can be sized and shaped to receive the proximal head portion 222 of the soft tissue anchoring portion 220 therein. The opening 214 can include a circumferential groove 216 extending around its perimeter and positioned between the first surface 206 and the second surface 208. The groove 216 can have a diameter larger than the diameter of the opening 214. It is further contemplated that the groove 216 can have a diameter at least as large as the major cross-sectional dimension 238 of the proximal head portion 222 of the soft tissue anchoring portion 220. As will be described in more detail, this allows the protrusion 234 of the proximal head portion 222 to be rotatably disposed within the groove 216. In some examples, the opening 214 can further include an axially extending slot 218a and / or an axially extending slot 218b (collectively, 218) (see, e.g., FIG. 7C). The slot 218 can extend from the circumferential groove 216 to the second surface 208 as shown in FIG. 7B. The slot 218 can have a width larger than the width of the protrusion 234 to allow the protrusion 234 to slide therein. It is contemplated that the depth of the slot 218 can be similar to the depth of the groove 216, but this is not essential. In other words, the slot 218 can extend to the same radial position as the circumferential groove 216. The slot 218 can be positioned, for example, diametrically opposite sides of the opening 214 (i.e., circumferentially spaced 180 degrees apart). In other examples, the circumferential groove 216 can be a helical groove extending to the second surface 208 of the frame 200.

[0159] To assemble the soft tissue anchoring portion 220 with the mounting arm 210, the protrusion 234 of the proximal head portion 222 may be aligned with the axially extending slot 218 adjacent to the second surface 208 of the mounting arm 210. Next, the protrusion 234 can be advanced in the slot 218 toward the circumferential groove 216 until further movement of the protrusion 234 is prevented by the upper edge of the circumferential groove 216. Next, as shown in FIG. 7C, the soft tissue anchoring portion 220 can be rotated so that the protrusion 234 is displaced circumferentially from the slot 218. When the protrusion 234 is displaced circumferentially from the slot 218, axial movement of the soft tissue anchoring portion 220 (e.g., movement between the first surface 206 and the second surface 208) can be made impossible. In an example where the circumferential groove 216 is a helical groove, the protrusion 234 can enter the circumferential groove 216 at the second surface 208 and can be rotated in the circumferential groove 216 to position the protrusion 234 in the circumferential groove 216. The implant 12 can be fixed adjacent to the second surface 208 of the frame 200 after assembly of the soft tissue anchoring portion 220 with the frame 200. It is contemplated that the soft tissue anchoring portion 220 can pierce or perforate the implant 12 (similar to FIG. 6B) to secure the implant 12 to the frame 200.

[0160] The frame 200, the implant 12, and the soft tissue anchoring portion 220 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be coupled to the frame 200 and can extend outside the body to facilitate retrieval of the frame 200 when the frame 200 is decoupled from the implant 12. Next, an instrument can be advanced to decouple the soft tissue anchoring portion 220 from the frame 200. In some cases, the instrument can be similar to a screwdriver-type instrument, but this is not essential. In some cases, the instrument can include a protrusion or recess configured to engage the protrusion 234 to facilitate rotation of the soft tissue anchoring portion 220. In other embodiments, the instrument can be configured to engage features at the proximal head portion 222, such as, but not limited to, grooves, recesses, angled sides, etc. The instrument can be aligned and engaged with the proximal head portion 222 of the soft tissue anchoring portion 220. Next, a rotational force can be applied to the instrument to rotate the soft tissue anchoring portion 220 until the protrusion 234 is aligned with the slot 218. In some cases, an axial force can be applied while rotating the soft tissue anchoring portion 220 such that the soft tissue anchoring portion 220 is axially displaced within the opening 214 when the protrusion 234 is aligned with the slot 218. If no axial force is applied during rotation, an axial force can be applied to the soft tissue anchoring portion 220 to advance the protrusion 234 along the slot 218 toward the second surface 208 when the protrusion 234 is aligned with the slot 218. The soft tissue anchoring portion 220 can be axially displaced until the proximal head portion 222 exits the opening 214 and the distal fixed end 224 pierces the body tissue.In some examples, after the soft tissue anchor 220 is rotated by an instrument to align the protrusion 234 with the slot 218, the instrument may be used as a punch or driver to exert an axial force on the soft tissue anchor 220, such as by tapping the soft tissue anchor 220 with a mallet to drive the soft tissue anchor 220 into the tissue. In an example where the circumferential groove 216 is a helical groove, rotation of the soft tissue anchor 220 by the instrument can twist the soft tissue anchor 220 into the tissue. The instrument can be repositioned to align with other soft tissue anchors 220, and the steps are repeated to disconnect additional soft tissue anchors 220 from the frame 200. This can be repeated for each soft tissue anchor 220. Thereby, the clinician can deploy multiple soft tissue anchors 220 without having to individually attach each soft tissue anchor 220 to the instrument and without having to repeatedly insert and remove the instrument.

[0161] FIG. 8A shows a perspective view of another exemplary attachment arm 310 and soft tissue anchor 320 of the frame 300. FIG. 8B is an exploded perspective view of the exemplary attachment arm 310 and soft tissue anchor 320 of the frame 300 of FIG. 8A. 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. FIG. 8C is a cross-sectional view of an exemplary attachment arm 310 taken along line 8C-8C of FIG. 8A. Although the soft tissue anchor 320 is described in relation to a single attachment arm 310, it should be understood that the soft tissue anchor 320 may be provided on any number of attachment arms 310 as desired.

[0162] In the exemplary embodiments of FIGS. 8A - 8C, the soft tissue anchoring portion 320 can be removably coupled to the mounting arm 310 via a retainer 340. The retainer 340 can be configured to slide across the free end of the mounting arm 310. Generally, the soft tissue anchoring portion 320 can be advanced through an opening 342 in the retainer and an opening 314 in the mounting arm 310. The retainer 340 can include features configured to engage mating features of the soft tissue anchoring portion 320 to releasably secure the soft tissue anchoring portion 320.

[0163] The soft tissue anchoring portion 320 can include a proximal head portion 322 configured to press against the implant 12 and a distal fixation end 324 configured to penetrate tissue. An elongated intermediate connection portion or body 326 can extend between the proximal head portion 322 and the distal fixation end 324. It is contemplated that the proximal head portion 322 can be a generally planar component having a width greater than the width of the intermediate connection portion or body 326. In some cases, the proximal head portion 322 may be generally disc-shaped having a generally circular cross-section. However, this is not essential. The proximal head portion 322 can have other cross-sectional shapes such as, but not limited to, square, rectangular, oval, polygonal, etc. The proximal head portion 322 can include a radially extending peripheral edge or detent 334 extending from the side surface of the proximal head portion 322. In some cases, the peripheral edge or detent 334 can extend around the entire perimeter of the proximal head portion 322. In other embodiments, the detent 334 can include a plurality of detents (e.g., two, three, four, or more) spaced apart around the perimeter of the proximal head portion 322. When two or more detents 334 are provided, the detents 334 can be raised features that are evenly spaced or unevenly spaced as desired. The detent 334 can be sized and shaped to mate with corresponding slots and / or grooves in the retainer 340 as described in more detail herein.

[0164] The distal fixation end 324 may generally be in a “V” shape, or may have a sharp tip, and may include a first engaging portion 328a and a second engaging portion 328b (collectively, 328). The distal fixation end 324 may be shaped such that when the distal fixation end 324 is assembled with the frame 300 and / or body tissue, proximal retraction of the soft tissue tether 320 is prevented or impeded. For example, each of the engaging portions 328 may include proximal ends 330a, 330b (collectively, 330) radially spaced from the intermediate connection portion 326, and distal ends 332a, 332b (collectively, 332) that are in contact with or connected to the distal fixation end 324. In some cases, fewer than two or more engaging portions 328 may be provided. In some cases, the proximal ends 330 of the engaging portions 328 may be configured to distort radially inwardly to facilitate distal advancement of the soft tissue tether 320 through the frame 300, the implant 12, and / or body tissue, and to return to an outwardly extending configuration (such as the configuration shown in FIGS. 8B and 8C) after insertion, although this is not essential. The distal fixation end 324 or distal tip of the soft tissue tether 320 is configured to lead the soft tissue tether 320 when advanced into body tissue. The engaging portions 328 are angled or inclined such that the soft tissue tether 320 can be easily advanced distally through the tissue, but proximal retraction of the soft tissue tether 320 is difficult or impossible. This can help ensure that the soft tissue tether 320 self - anchors when assembled with the frame 300 and / or the implant 12 and / or when implanted into the tissue. The angle and / or length of the engaging portions 328 may be varied. It is contemplated that the engaging portions 328 may have a structure or shape different from an angled surface, including, but not limited to, curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 328 may be used to help fix the soft tissue tether 320 to the frame 300 and the implant 12 and / or into the tissue.

[0165] The intermediate connection portion or body 326 can be an elongated bar generally having a cylindrical shape, but can take other shapes as desired. The intermediate connection portion or body 326 is shown as generally having a uniform cross-sectional dimension, but it is contemplated that the cross-sectional dimension of the intermediate connection portion or body 326 may vary along its length. For example, the intermediate connection portion or body 326 may have a reduced cross-sectional dimension from the proximal head portion 322 toward the distal fixed end 324. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 320 may be formed as a single integral structure or as a series of components fixed to each other as desired.

[0166] It is further contemplated that the soft tissue anchoring portion 320 can take other configurations. For example, the soft tissue anchoring portion 320 can be a "U"-shaped tissue anchoring portion with hooks similar to a staple needle having two legs extending distally. In such an example, the hooked edge or legs penetrate the tissue and are fixed within the tissue, while the "U" connection portion or bridge portion provides support for holding the implant 12 between the hooked legs. In other embodiments, the soft tissue anchoring portion 320 can be a screw having a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for holding the implant. This is merely an example.

[0167] The attachment arm 310 may include a generally circular opening 314 configured to receive a portion of the soft tissue anchoring portion 320. However, the opening 314 can take other shapes as desired. The opening 314 can have a cross-sectional shape similar to the general cross-sectional shape of the proximal head portion 322 of the soft tissue anchoring portion 320, and extends through the thickness of the attachment arm 310 from a first surface 306 (e.g., a first surface facing away from the implant 12 when the implant 12 is attached to the frame 300, such as a first surface facing away from the target site in the body) and a second surface 308 (e.g., a second surface facing the exemplary implant 12 or juxtaposed with the exemplary implant 12, such as a second surface facing the target site in the body). The opening 314 can be sized and shaped to allow the proximal head portion 322 of the soft tissue anchoring portion 320 to pass through the opening 314. For example, the opening 314 can have a diameter 316 that is larger than the diameter 336 of the proximal head portion 322 and larger than the maximum diameter 338 of the proximal head portion 322 (e.g., at the detent 334).

[0168] The retaining body 340 can include an upper side 344 that faces away from the implant 12 when the implant 12 is attached to the frame 300, a lower side 346 that faces the implant 12 when the implant 12 is attached to the frame 300, a first lateral side 348 that extends between the upper side 344 and the lower side 346, and a second lateral side 350 that extends between the upper side 344 and the lower side 346 and is opposite the first lateral side. Collectively, the upper side 344, the lower side 346, the first lateral side 348, and the second lateral side 350 can define a passageway 352 that extends from a first end 354 of the retaining body 340 to a second end 356. The passageway 352 can be sized and shaped such that (as shown in FIG. 8A) the retaining body 340 can be slid across the attachment arm 310 while preventing the retaining body 340 from inadvertently disengaging from the attachment arm 310 prior to assembly with the soft tissue anchoring portion 320. The retaining body 340 can further include a first opening 358 in the upper side 344 and a second opening 360 defined in the lower side 346. The first opening 358 and the second opening 360 can generally be circular, but can take other shapes as desired. The first opening 358 and the second opening 360 can generally be aligned to define an opening 342 that extends from the upper side 344 to the lower side 346. The first opening 358 and the second opening 360 can have the same diameter, the same diameter, or different diameters as desired. In some embodiments, the first opening 358 can have a diameter that is similar or the same as the diameter 336 of the proximal head portion 322 of the soft tissue anchoring portion 320, and the second opening 360 can have a diameter that is larger than the maximum diameter 338 of the proximal head portion 322 at the detent 334.

[0169] To assemble the soft tissue tether 320 with the mounting arm 310, the holder 340 can be advanced over the free end of the mounting arm 310 until the opening 342 of the holder 340 is generally aligned with the opening 314 of the mounting arm 310. Next, the distal fixation end 324 of the soft tissue tether 320 can be advanced through the openings 314, 342, in a direction from the upper side 344 to the lower side 346 of the holder 340, or from the lower side 346 to the upper side 344, if desired. The soft tissue tether 320 can be advanced until a detent 334 in the proximal head region 322 engages a mating recess 362 (see, e.g., FIG. 8C) formed in the sidewall of a first opening 358 formed in the upper side 344 of the holder 340. The detent 334 and the corresponding recess 362 can form a snap fit or other mechanical engagement to maintain the soft tissue tether 320 in a desired configuration during delivery of the implant 12. It is contemplated that the implant 12 can be positioned adjacent to the second surface 308 of the frame 300 and / or the lower side 346 of the holder 340 during assembly such that the soft tissue tether 320 pierces the implant 12 and secures the implant 12 to the frame 300.

[0170] Frame 300, implant 12, and soft tissue anchoring portion 320 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be coupled to the frame 300 and can extend outside the body to facilitate retrieval of the frame 300 when the frame 300 is decoupled from the implant 12. Next, an instrument can be advanced to decouple the soft tissue anchoring portion 320 from the frame 300. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 322 of the soft tissue anchoring portion 320. Next, force can be applied with a mallet or the like to advance the soft tissue anchoring portion 320 distally such that the distal fixed end 324 or distal tip pierces the tissue. It is contemplated that when force is applied to the proximal head portion 322, the upper side 344 of the retainer 340 can bend, distort, deform, or break, releasing the detent 334 from the mating recess 362. As previously described, the second opening 360 can be sized such that the maximum diameter 338 of the proximal head portion 322 can easily pass through, but this is not essential. The instrument can be repositioned to align with other soft tissue anchoring portions 320, and force is exerted on the soft tissue anchoring portion 320 to decouple it from the frame 300. This can be repeated for each soft tissue anchoring portion 320. Thereby, the clinician can deploy multiple soft tissue anchoring portions 320 without the need to individually attach each soft tissue anchoring portion 320 to the instrument and without the need for repeated insertion and removal of the instrument.

[0171] FIG. 8D is a cross-sectional view of an alternative retainer 370 assembled with the attachment arm 310 and the soft tissue anchoring portion 320'. For clarity, the implant is not shown. However, it should be understood that the implant 12 can be assembled with the attachment arm 310, the soft tissue anchoring portion 320', and the retainer 370 in a manner similar to that shown in FIG. 8C. FIG. 8E is a perspective view of an exemplary retainer 370 after the soft tissue anchoring portion 320' has been deployed therefrom. The soft tissue anchoring portion 320' can be similar in form and function to the soft tissue anchoring portion 320 described in connection with FIGS. 8A-8C, and like elements are designated with like reference numerals. The soft tissue anchoring portion 320' may or may not have a radially extending detent, which is not essential. In some examples, the lower surface of the proximal head portion 322 of the soft tissue anchoring portion 320' may include an inclined surface and / or the upper surface or upper side 372 of the retainer 370 may include an inclined surface leading to the first opening 386 to facilitate advancement of the head portion 322 of the soft tissue anchoring portion 320' through the first opening 386 of the retainer 370.

[0172] The retaining body 370 can include an upper side 372 that faces away from the implant 12 when the implant 12 is attached to the frame 300, a lower side 374 that faces the implant 12 when the implant 12 is attached to the frame 300, a first lateral side 376 that extends between the upper side 372 and the lower side 374, and a second lateral side 378 that extends between the upper side 372 and the lower side 374 and is opposite the first lateral side. Collectively, the upper side 372, the lower side 374, the first lateral side 376, and the second lateral side 378 can define a passageway 380 that extends from a first end 382 to a second end 384 of the retaining body 370. The passageway 380 can be sized and shaped such that the retaining body 370 can be slid across the attachment arm 310 while preventing the retaining body 370 from unintentionally disengaging from the attachment arm 310 prior to assembly with the soft tissue anchoring portion 320'. The retaining body 370 can further include a first opening 386 in the upper side 372 and a second opening 388 defined in the lower side 374. The first opening 386 and the second opening 388 can generally be circular, but can take other shapes as desired. The first opening 386 and the second opening 388 can generally be aligned to define an opening 390 that extends from the upper side 372 to the lower side 374. The first opening 386 and the second opening 388 can have the same or similar diameter 392, but this is not essential. It is contemplated that the first opening 386 and the second opening 388 can have different diameters as desired. The diameter 392 of the openings 386, 388 can be made smaller than the diameter 336 of the proximal head portion 322 of the soft tissue anchoring portion 320' such that when the soft tissue anchoring portion 320' is assembled with the retaining body 370 and the attachment arm 310, the proximal head portion 322 presses onto the upper side 372 as shown in FIG. 8D. The diameter 316 of the opening 314 of the attachment arm 310 can be larger than the diameter 336 (and the diameter 392 of the openings 386, 388) of the proximal head portion 322 such that the proximal head portion 322 of the soft tissue anchoring portion 320' can freely pass through the opening 314 during deployment.

[0173] To assemble the soft tissue tether 320' with the mounting arm 310, the holder 370 can be advanced across the free end of the mounting arm 310 until the opening 390 of the holder 370 is roughly aligned with the opening 314 of the mounting arm 310. Next, the distal fixation end 324 of the soft tissue tether 320' can be advanced through the openings 314, 390 in a direction from the upper side 372 to the lower side 374 of the holder 370. The soft tissue tether 320' can be advanced until the lower surface of the proximal head region 322 engages the upper side 372 of the holder 370. It is contemplated that the distal fixation end or distal tip of the soft tissue tether 320' can pierce an implant to fix the soft tissue tether 320' to the frame 300. For example, the structure of the distal fixation end 324 of the soft tissue tether 320' can prevent the tether 320' from retracting when piercing the implant. It is contemplated that during assembly, the implant 12 can be positioned adjacent to the second surface 308 of the frame 300 and / or the lower side 374 of the holder 370 such that the soft tissue tether 320' pierces the implant 12 and fixes the implant 12 to the frame 300 during delivery of the implant 12 to the target site.

[0174] The frame 300, the implant, and the soft tissue anchoring portion 320' can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant can be temporarily fixed using, for example, a bone tack when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be coupled to the frame 300 and can extend out of the body to facilitate retrieval of the frame 300 when the frame 300 is decoupled from the implant 12. Next, an instrument can be advanced to decouple the soft tissue anchoring portion 320' from the frame 300. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 322 of the soft tissue anchoring portion 320'. Next, a force can be applied to advance the soft tissue anchoring portion 320' distally such that the distal fixed end 324 or distal tip pierces the tissue. It is contemplated that when a force is applied to the proximal head portion 322, the upper side 372 of the retainer 370 can bend, distort, deform, or break, allowing the proximal head portion 322 to pass through the opening 390. In some cases, a weak region may be formed in the retainer 370 such that the retainer 370 breaks at a predetermined location 394. However, this is not essential. It is further contemplated that the retainer 370 may be flexible to allow the proximal head portion 322 to pass through without mechanical damage to the retainer 370. In some cases, a second opening 388 can be sized such that the proximal head portion 322 can easily pass through, but this is not essential. The instrument can be repositioned to align with other soft tissue anchoring portions 320', and a force is exerted on the soft tissue anchoring portion 320' to decouple it from the frame 300. This can be repeated for each soft tissue anchoring portion 320'. Thereby, the clinician can deploy multiple soft tissue anchoring portions 320' without the need to individually attach each soft tissue anchoring portion 320' to the instrument and without the need for repeated insertion and removal of the instrument.

[0175] FIG. 9A shows an exploded perspective view of another exemplary attachment arm 410 of frame 400 and soft tissue anchoring portion 420. FIG. 9B is a perspective view of an exemplary attachment arm 410 of frame 400 assembled with soft tissue anchoring portion 420. Frame 400 may be similar in form and function to frame 100 described herein. Soft tissue anchoring portion 420 may be configured to be assembled with frame 400 and implant 12 (not explicitly shown) to releasably secure the implant to frame 400. Although soft tissue anchoring portion 420 is described in relation to a single attachment arm 410, it should be understood that soft tissue anchoring portion 420 may be provided on any number of attachment arms 410 as desired.

[0176] Soft tissue anchoring portion 420 may include a proximal head portion 422 configured to hold down implant 12 and a distal fixation end 424 configured to pierce tissue. An elongated intermediate connection portion or body 426 may extend between proximal head portion 422 and distal fixation end 424. It is contemplated that proximal head portion 422 may be a generally planar component having a width greater than the width of intermediate connection portion 426. In some cases, proximal head portion 422 may be generally disc-shaped having a generally circular cross-sectional shape. However, this is not essential. Proximal head portion 422 may have other cross-sectional shapes, such as, but not limited to, square, rectangular, oval, polygonal, etc.

[0177] The distal fixation end 424 may generally be in a “V” shape, or may have a sharp tip, and may include a first engaging portion 428a and a second engaging portion 428b (collectively, 428). The distal fixation end 424 may be shaped such that when the distal fixation end 424 is assembled with the frame 400 and / or body tissue, proximal retraction of the soft tissue anchoring portion 420 is prevented or impeded. For example, each of the engaging portions 428 may include proximal ends 430a, 430b (collectively, 430) radially spaced from the intermediate connecting portion or body 426, and distal ends 432a, 432b (collectively, 432) that are in contact with or connected to the distal fixation end 424. In some cases, fewer than two or more engaging portions 428 may be provided. In some cases, the proximal ends 430 of the engaging portions 428 may be configured to distort radially inwardly to facilitate distal advancement of the soft tissue anchoring portion 420 through the frame 400, the implant 12, and / or body tissue, and to return to an outwardly extending configuration (such as the configuration shown in FIG. 9A) after insertion, although this is not essential. The distal fixation end 424 or distal tip of the soft tissue anchoring portion 420 is configured to lead the soft tissue anchoring portion 420 when advanced into the body tissue. The engaging portions 428 are angled or inclined such that the soft tissue anchoring portion 420 can be easily advanced distally through the tissue, but proximal retraction of the soft tissue anchoring portion 420 is difficult or impossible. This can help ensure that the soft tissue anchoring portion 420 self-anchors when assembled with the frame 400 and / or implant 12 and / or when implanted into the tissue. The angle and / or length of the engaging portions 428 may be varied. It is contemplated that the engaging portions 428 may have a structure or shape different from an angled surface, including, but not limited to, curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 428 may be used to help fix the soft tissue anchoring portion 420 to the frame 400 and implant 12 and / or within the tissue.

[0178] The intermediate connection portion or body 426 can be an elongated bar generally having a cylindrical shape, but can take other shapes as desired. The intermediate connection portion or body 426 is shown as generally having a cross-sectional dimension of a uniform diameter 434, but it is contemplated that the cross-sectional dimension of the intermediate connection portion or body 426 may vary along its length. For example, the intermediate connection portion or body 426 may have a reduced cross-sectional dimension from the proximal head portion 422 towards the distal fixed end 424. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 420 may be formed as a single integral structure, or a series of components fixed to each other, as desired.

[0179] It is further contemplated that the soft tissue anchoring portion 420 can take other configurations. For example, the soft tissue anchoring portion 420 can be a "U"-shaped tissue anchoring portion with hooks similar to the needle of a stapler, having two legs extending distally. In such an example, the hooked edge or legs penetrate the tissue and are fixed within the tissue, while the "U" shaped connection portion or bridge portion provides support for holding the implant 12 between the hooked legs. In other embodiments, the soft tissue anchoring portion 420 can be a screw having a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for holding the implant. This is merely an example.

[0180] The attachment arm 410 may include a first flexible arm 412a and a second flexible arm 412b (collectively, 412) adjacent to its free end. Since the flexible arms 412 include the first flexible arm 412a and the second flexible arm 412b with slots or openings therebetween, it has been considered that they can be formed by removing some material from the attachment arm 410 or by molding the attachment arm 410, but other techniques may be used as desired. The flexible arms 412 may increase in width towards the free end to define a distal opening 414 having a first width 418 and an opening 416 having a second width 440. The width 418 of the distal opening 414 may be made smaller than the width 440 of the spaced-apart opening 416 proximal to the distal opening 414. The distal opening 414 and the opening 416 can extend through the thickness of the attachment arm 410 from a first surface 406 (e.g., a first surface facing away from the target site on the body) facing away from the implant 12 when the implant 12 is attached to the frame 400 and a second surface 408 (e.g., a second surface facing the target site on the body) facing the exemplary implant 12. The opening 416 can be sized and shaped to prevent passage of the proximal head portion 422 of the soft tissue tether 420 through itself. For example, the width 440 of the opening 416 may be sufficient to receive the intermediate connection portion or body 426, but may be made smaller than the width or diameter 436 of the proximal head portion 422. The width of the opening 414 may be made smaller than both the width or diameter 436 of the proximal head portion 422 and the width or diameter of the intermediate connection portion or body 426.

[0181] The flexible arm 412 can be configured to bend temporarily away from the longitudinal axis 444 of the mounting arm 410 (or generally orthogonally to the longitudinal axis 444), as shown at arrows 442a, 442b (collectively, 442). It is contemplated that the flexible arm 412 can be configured to bend in the direction shown at arrow 442 (i.e., bend away from each other) to temporarily widen the distal opening 414 in response to an applied force and return to its original unbiased configuration when no force is applied. In some cases, the intermediate connection portion or torso 426 of the soft tissue tether 420 can have a diameter 434 that is larger than the width 418 of the distal opening 414. To assemble the soft tissue tether 420 with the mounting arm 410, the intermediate portion or torso 426 can be pushed through the distal opening 414 in a lateral direction parallel to the longitudinal axis 444 of the mounting arm 410. The intermediate portion or torso 426 can deflect the flexible arms 412 outwardly 442 to pass the intermediate portion 426 through the distal opening 414 into the opening 416. When the intermediate portion or torso 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). When no force is applied, the intermediate portion or torso 426 is held within the opening 416 with the head portion 422 above the upper surface 406 of the mounting arm 410 and the distal fixed end 424 positioned below the lower surface 408 of the mounting arm 410. The diameter 440 of the opening 416 may be larger than the diameter 434 of the intermediate portion or torso 426 such that the intermediate portion 426 can move freely within the opening 416. In other embodiments, the diameter 440 of the opening 416 can be approximately the same as the diameter 434 of the intermediate portion or torso 426 to create a friction fit between the intermediate portion or torso 426 and the mounting arm 410. Alternatively, the soft tissue tether 420 can be assembled with the mounting arm 410 by axially advancing the distal fixed end 424 through the opening 416 in the direction from the first surface 406 to the second surface 408.It has been considered that the engaging portion 428 can be distorted toward the intermediate portion 426 to allow the distal fixation end 424 to pass through the opening 416. The implant 12 can be fixed adjacent to the second surface 408 of the frame 400 either simultaneously with or after the assembly of the soft tissue anchoring portion 420 with the frame 400. It has been considered that the soft tissue anchoring portion 420 can pierce or perforate the implant 12 (similar to FIG. 6B) to fix the implant 12 to the frame 400 for delivery to the target site.

[0182] The frame 400, the implant 12, and the soft tissue anchoring portion 420 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be coupled to the frame 400 and can extend out of the body to facilitate retrieval of the frame 400 when the frame 400 is decoupled from the implant 12. Next, an instrument can be advanced to decouple the soft tissue anchoring portion 420 from the frame 400. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 422 of the soft tissue anchoring portion 420. Next, a force can be applied to advance the soft tissue anchoring portion 420 distally so that the distal fixed end 424 or distal tip pierces the tissue. The instrument can be repositioned to align with other soft tissue anchoring portions 420, and a force is exerted on the soft tissue anchoring portion 420 to decouple the soft tissue anchoring portion 420 from the frame 400. This can be repeated for each soft tissue anchoring portion 420. Thereby, the clinician can deploy multiple soft tissue anchoring portions 420 without the need to individually attach each soft tissue anchoring portion 420 to the instrument and without the need for repeated insertion and removal of the instrument. Once each soft tissue anchoring portion 420 is driven into the tissue, the frame 400 can be retracted from the body. Retraction of the frame 400 can exert a lateral pulling force on the attachment arm 410, which can further bias the flexible arm 412 outwardly 442, pass the attachment arm 410 over the intermediate portion or torso 426 of the soft tissue anchoring portion 420, and release the frame 400 from the soft tissue anchoring portion 420.

[0183] FIG. 9C shows a cross-sectional view of an alternative soft tissue anchor 420' for use with the attachment arm 410 of FIGS. 9A and 9B. The soft tissue anchor 420' can be made similar in form and function to the soft tissue anchor 320 described in connection with FIGS. 9A-9B, and like elements are given like reference numerals. The soft tissue anchor 420' may further comprise a circumferentially extending recess 450 formed in the proximal head portion 422. The recess 450 may have a height 452 (e.g., the distance from the first surface 406 to the second surface 408) that is similar to the thickness of the attachment arm 410. It is further contemplated that the cross-section or diameter 454 of the proximal head portion 422 in the recess 450 may be the same as, the same as, or larger than the diameter 440 of the opening 416 in the attachment arm 410.

[0184] To assemble the soft tissue anchor 420' with the attachment arm 410, the proximal head portion 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 portion 422 can deflect the flexible arms 412 outwardly (as shown in FIG. 9A) to pass the proximal head portion 422 through the distal opening 414 and into the opening 416. When the proximal head portion 422 has passed through the distal opening 414, the flexible arms 412 return to or toward their original un-deflected configuration, or move laterally inwardly to apply a gripping or pinching force to the proximal head portion 422. The recess 450 of the proximal head portion 422 can be positioned such that a portion of the flexible arms 412 is disposed within the recess 450. In the absence of applied force, the proximal head portion 422 is retained within the opening 416. The implant 12 can be secured adjacent to the second surface 408 of the frame 400 either simultaneously with or after the assembly of the soft tissue anchor 420' with the frame 400. It is contemplated that the soft tissue anchor 420' can pierce or perforate the implant 12 (similar to FIG. 6B) to secure the implant 12 to the frame 400.

[0185] The frame 400, the implant 12, and the soft tissue anchoring portion 420' can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be connected to the frame 400 and can extend out of the body to facilitate retrieval of the frame 400 when the frame 400 is disconnected from the implant 12. Next, an instrument can be advanced to disconnect the soft tissue anchoring portion 420' from the frame 400. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 422 of the soft tissue anchoring portion 420'. Next, a force can be applied to advance the soft tissue anchoring portion 420' distally so that the distal fixed end 424 or the distal tip pierces the tissue. The instrument can be repositioned to align with other soft tissue anchoring portions 420', and a force is exerted on the soft tissue anchoring portion 420' to disconnect the soft tissue anchoring portion 420' from the frame 400. This can be repeated for each soft tissue anchoring portion 420'. Thereby, the clinician can deploy multiple soft tissue anchoring portions 420' without the need to individually attach each soft tissue anchoring portion 420' to the instrument and without the need for repeated insertion and removal of the instrument. Once each soft tissue anchoring portion 420' is driven into the tissue, the frame 400 can be retracted from the body. Retraction of the frame 400 can exert a lateral pulling force on the attachment arm 410, which can further bias the flexible arm 412 outwardly 442, pass the attachment arm 410 beyond the proximal head portion 422 of the soft tissue anchoring portion 420', and release the frame 400 from the soft tissue anchoring portion 420'.

[0186] FIG. 10A shows an exploded perspective view of another exemplary attachment arm 510 and soft tissue anchoring portion 520 of frame 500. FIG. 10B is a perspective view of an exemplary attachment arm 510 of frame 500 assembled with soft tissue anchoring portion 520. Frame 500 may be similar in form and function to frame 100 described herein. Soft tissue anchoring portion 520 may be configured to be assembled with frame 500 and an implant 12 (not explicitly shown) to releasably secure the implant to frame 500. Although soft tissue anchoring portion 520 is described in relation to a single attachment arm 510, it should be understood that soft tissue anchoring portion 520 may be provided on any number of attachment arms 510 as desired.

[0187] Soft tissue anchoring portion 520 may include a proximal head portion 522 configured to hold down implant 12, and a distal fixation end 524 configured to pierce tissue. An elongate intermediate connecting portion or body 526 may extend between proximal head portion 522 and distal fixation end 524. It is contemplated that proximal head portion 522 may have a width greater than the width of intermediate connecting portion 526. Proximal head portion 522 may include an upper side 534 that faces away from implant 12 when implant 12 is attached to frame 500, a lower side 536 that faces implant 12 or is juxtaposed with implant 12 when implant 12 is attached to frame 500, a first lateral side 538 that extends between upper side 534 and lower side 536, and a second lateral side 540 that extends between upper side 534 and lower side 536 and is opposite first lateral side 538. Collectively, upper side 534, lower side 536, first lateral side 538, and second lateral side 540 may define a passageway 542 that extends from a first end 544 to a second end 546 of proximal head portion 522. Passageway 542 may be sized and shaped such that proximal head portion 522 can be slid across attachment arm 510 (as shown in FIG. 10B), while preventing proximal head portion 522 from inadvertently disengaging from attachment arm 510 prior to assembly with soft tissue anchoring portion 520.

[0188] The distal fixation end 524 may generally be in a “V” shape, or may have a sharp tip, and may include a first engaging portion 528a and a second engaging portion 528b (collectively, 528). The distal fixation end 524 may be shaped such that when the distal fixation end 524 is assembled with the frame 500 and / or body tissue, proximal retraction of the soft tissue anchoring portion 520 is prevented or impeded. For example, each of the engaging portions 528 may include proximal ends 530a, 530b (collectively, 530) radially spaced from an intermediate connecting portion or body 526, and distal ends 532a, 532b (collectively, 532) that are in contact with or connected to the distal fixation end 524. In some cases, fewer than two or more engaging portions 528 may be provided. In some cases, the proximal ends 530 of the engaging portions 528 may be configured to distort radially inwardly to facilitate distal advancement of the soft tissue anchoring portion 520 through the frame 500, the implant 12, and / or body tissue, and to return to an outwardly extending configuration (such as the configuration shown in FIG. 10A) that expands after insertion, although this is not essential. The distal fixation end or distal tip of the soft tissue anchoring portion 520 is configured to lead the soft tissue anchoring portion 520 when advanced into body tissue. The engaging portions 528 are angled or inclined such that the soft tissue anchoring portion 520 can be easily advanced distally through tissue, but proximal retraction of the soft tissue anchoring portion 520 is made difficult or impossible. This can help ensure that the soft tissue anchoring portion 520 self-anchors when assembled with the frame 500 and / or implant 12 and / or implanted into tissue. The angle and / or length of the engaging portions 528 may be varied. It is contemplated that the engaging portions 528 may have a structure or shape different from an angled surface, including, but not limited to, curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 528 may be used to help fix the soft tissue anchoring portion 520 to the frame 500 and implant 12 and / or within tissue.

[0189] The intermediate connection portion or body 526 can be an elongated bar generally having a cylindrical shape, but can take other shapes as desired. The intermediate connection portion or body 526 is shown as generally having a cross-sectional dimension with a uniform diameter, but it is contemplated that the cross-sectional dimension of the intermediate connection portion or body 526 may vary along its length. For example, the intermediate connection portion or body 526 may have a reduced cross-sectional dimension from the proximal head portion 522 toward the distal fixed end 524. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 520 may be formed as a single integral structure or as a series of components fixed to each other as desired.

[0190] It is further contemplated that the soft tissue anchoring portion 520 can take other configurations. For example, the soft tissue anchoring portion 520 can be a "U"-shaped tissue anchoring portion with hooks similar to a stapler needle having two legs extending distally. In such an example, the hooked edge or legs penetrate the tissue and are fixed within the tissue, while the "U" shaped connection portion or bridge portion provides a passage for engaging the attachment arm 510 and provides support for holding the implant 12 between the hooked legs. In other embodiments, the soft tissue anchoring portion 520 can be a screw having a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for holding the implant. This is merely an example.

[0191] The mounting arm 510 may include a first flexible arm 512a and a second flexible arm 512b (collectively, 512) adjacent to its free end. Since the flexible arms 512 include the first flexible arm 512a and the second flexible arm 512b with slots or openings therebetween, it has been considered that they can be formed by removing some material from the mounting arm 510 or by molding the mounting arm 510, although other techniques may be used as desired. Each of the flexible arms 512 may include proximal portions 511a, 511b (collectively, 511) that generally extend parallel to the longitudinal axis 504 of the mounting arm 510, and distal portions 513a, 513b (collectively, 513) that extend at an angle not parallel to the longitudinal axis 504 of the mounting arm 510. The arms 512 can define a gap 516 or region without material therebetween. The proximal end of the gap 516 may include a strain relief notch 518 in some examples. The gap 516 can bend the flexible arms 512 inwardly toward the longitudinal axis 504, as indicated by arrows 550a, 550b (collectively, 550), and, by extension, the flexible arms 512 can bend inwardly toward each other. Each of the free ends 514a, 514b (collectively, 514) of the flexible arms 512 may curve away from the longitudinal axis 504 of the mounting arm 510 such that, for example, the width 552 of the mounting arm 510 adjacent to the free end 514 is greater than the width 554 adjacent to the proximal portion 511 of the flexible arm and / or the width 554 of the mounting arm 510 adjacent to the strain relief portion 518. The free end 514 is described as generally having a curved configuration, although it has been considered that other configurations that increase the width 552 at the free end 514 relative to the width 554 adjacent to the strain relief portion 518 may be included.

[0192] The flexible arm 512 can be configured to bend temporarily towards the longitudinal axis 504 of the mounting arm 510 (or generally orthogonally to the longitudinal axis 504), and thus towards each other, as shown at arrows 550a, 550b (collectively, 550). It is contemplated that the flexible arm 512 can be configured to bend in the direction shown at arrow 550 in order to temporarily narrow the width 552 adjacent to the free end 514 in response to an applied force, and to return to its original configuration when no force is applied. The passage 542 of the proximal head portion 522 of the soft tissue tether 520 can have a width 548 that is greater than the width 554 of the mounting arm 510 adjacent to the strain relief 518, or less than the width 552 at the free end 514 in a relaxed or unbiased configuration. The strain of the flexible arm 512 in direction 550 can temporarily reduce the width 552 in order to insert the flexible arm 512 into the passage 542 of the proximal head portion 522 of the soft tissue tether 520. The soft tissue tether 520 can be slid along the mounting arm 510 (or the mounting arm 510 can be slid within the passage 542) until it is disposed across the proximal portion 511 of the flexible arm 512. When the soft tissue tether 520 is disposed across the proximal portion 511 of the flexible arm 512, the flexible arm 512 can return to or towards its original unbiased configuration, 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 passage 542 to hold the soft tissue tether 520 on the mounting arm 510. The width 548 of the passage 542 may be made greater than the width 554 of the proximal portion 511 of the flexible arm 512 such that the soft tissue tether 520 can slide freely across a portion of the mounting arm 510. Alternatively, the width 548 of the passage 542 can be approximately 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 tether to the mounting arm 510. The implant 12 can be secured adjacent to the second surface 508 of the frame 500 either simultaneously with or after the assembly of the soft tissue tether 520 with the frame 500.It has been contemplated that the soft tissue anchoring portion 520 can pierce or perforate the implant 12 (similar to FIG. 6B) to fix the implant 12 to the frame 500 for delivery to the target site.

[0193] The frame 500, the implant 12, and the soft tissue anchoring portion 520 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be connected to the frame 500 and can extend out of the body to facilitate retrieval of the frame 500 when the frame 500 is disconnected from the implant 12. Next, the instrument can be advanced to disconnect the soft tissue anchoring portion 520 from the frame 500. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 522 of the soft tissue anchoring portion 520. Next, force can be applied to advance the soft tissue anchoring portion 520 distally so that the distal fixed end 524 or the distal tip pierces the tissue. The instrument can be repositioned to align with other soft tissue anchoring portions 520, and force is exerted on the soft tissue anchoring portion 520 to disconnect the soft tissue anchoring portion 520 from the frame 500. This can be repeated for each soft tissue anchoring portion 520. Thereby, the clinician can deploy multiple soft tissue anchoring portions 520 without the need to individually attach each soft tissue anchoring portion 520 to the instrument and without the need for repeated insertion and removal of the instrument. When each soft tissue anchoring portion 520 is driven into the tissue, the frame 500 can be retracted from the body. Retraction of the frame 500 can exert a lateral pulling force on the attachment arm 510, which can further bias the flexible arm 512 inwardly to 550. The attachment arm 510 can pass through the passage 542 of the proximal head portion 522 of the soft tissue anchoring portion 520, releasing the frame 500 from the soft tissue anchoring portion 520.

[0194] FIG. 11A shows an exploded perspective view of another exemplary attachment arm 610 of the frame 600 and the soft tissue anchoring portion 620. FIG. 11B is a side view of an exemplary attachment arm 610 of the frame 600 assembled with the soft tissue anchoring portion 620 and the implant 12. The frame 600 may be similar in form and function to the frame 100 described herein. The soft tissue anchoring portion 620 may be configured to be assembled with the frame 600 and the implant 12 (not explicitly shown) to releasably secure the implant 12 to the frame 600. Although the soft tissue anchoring portion 620 is described in relation to a single attachment arm 610, it should be understood that the soft tissue anchoring portion 620 may be provided on any number of attachment arms 610 as desired.

[0195] The soft tissue anchoring portion 620 may include a proximal head portion 622 configured to hold down the implant 12, and a distal fixation end 624 configured to penetrate the tissue. An elongated intermediate connection portion or body 626 may extend between the proximal head portion 622 and the distal fixation end 624. It is contemplated that the proximal head portion 622 may have a width greater than the width of the intermediate connection portion 626. The proximal head portion 622 includes an upper side 634 that faces away from the implant 12 when the implant 12 is attached to the frame 600, a lower side 636 that faces the implant 12 when the implant 12 is attached to the frame 600, a first lateral side 638 that extends between the upper side 634 and the lower side 636, and a second lateral side 640 that extends between the upper side 634 and the lower side 636 and is opposite the first lateral side 638. Collectively, the upper side 634, the lower side 636, the first lateral side 638, and the second lateral side 640 can define a passage 642 that extends from a first end 644 to a second end 646 of the proximal head portion 622. The passage 642 can allow the proximal head portion 622 to slide across the attachment arm 610 (as shown in FIG. 11B), while being sized and shaped to prevent the proximal head portion 622 from unintentionally disengaging from the attachment arm 610 prior to assembly with the soft tissue anchoring portion 620.

[0196] The distal fixation end 624 may generally be in a "V" shape or may have a sharp tip, and may include a first engaging portion 628a and a second engaging portion 628b (collectively, 628). The distal fixation end 624 may be shaped such that when the distal fixation end 624 is assembled with the frame 600 and / or body tissue, proximal retraction of the soft tissue anchoring portion 620 is prevented or impeded. For example, each of the engaging portions 628 may include proximal ends 630a, 630b (collectively, 630) radially spaced from the intermediate connecting portion or body 626, and distal ends 632a, 632b (collectively, 632) that are in contact with or connected to the distal fixation end 624. In some cases, fewer than two or more engaging portions 628 may be provided. In some cases, the proximal ends 630 of the engaging portions 628 may be configured to distort radially inward to facilitate distal advancement of the soft tissue anchoring portion 620 through the frame 600, the implant 12, and / or body tissue, and to return to a configuration that extends outwardly after insertion and expands (such as the configuration shown in FIG. 11A), although this is not essential. The distal fixation end 624 of the soft tissue anchoring portion 620 is configured to lead the soft tissue anchoring portion 620 when advanced into the body tissue. The engaging portions 628 are angled or inclined such that the soft tissue anchoring portion 620 can be easily advanced distally through the tissue, but proximal retraction of the soft tissue anchoring portion 620 is made difficult or impossible. This can help ensure that the soft tissue anchoring portion 620 self-anchors when assembled with the frame 600 and / or the implant 12 and / or implanted into the tissue. The angle and / or length of the engaging portions 628 may be varied. It is contemplated that the engaging portions 628 may have a structure or shape different from the angled surface, including but not limited to curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 628 may be used to help fix the soft tissue anchoring portion 620 to the frame 600 and the implant 12 and / or within the tissue.

[0197] The intermediate connection portion or body 626 can be an elongated bar generally having a cylindrical shape, but can take other shapes as desired. Although the intermediate connection portion or body 626 is shown as generally having a uniform diameter cross-sectional dimension, it is contemplated that the cross-sectional dimension of the intermediate connection portion or body 626 may vary along its length. For example, the intermediate connection portion or body 626 may have a reduced cross-sectional dimension from the proximal head portion 622 towards the distal fixed end 624. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 620 may be formed as a single integral structure or as a series of components fixed to each other, as desired.

[0198] It is further contemplated that the soft tissue anchoring portion 620 can take other configurations. For example, the soft tissue anchoring portion 620 can be a "U"-shaped tissue anchoring portion with hooks similar to a staple needle having two legs extending distally. In such an example, the hooked edge or legs penetrate the tissue and are fixed within the tissue, while the "U" shaped connection portion or bridge provides a passage for engaging with the attachment arm 610 and provides support for holding down the implant 12 between the hooked legs. In other embodiments, the soft tissue anchoring portion 620 may have a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for holding down the implant. This is merely an example.

[0199] The attachment arm 610 may include a raised detent portion 612 positioned adjacent to its free end 614. The detent portion 612 may extend in a direction away from the implant 12 from the first surface 606 of the frame 600 (e.g., the surface facing away from the implant 12). However, it is contemplated that the detent portion 612 may extend in a direction toward the implant 12 from the second surface 608 of the frame 600 (e.g., the surface facing the implant 12). In some embodiments, the detent portion 612 may be provided on both the first surface 606 and the second surface 608. The detent portion 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 distal side 616 may increase in height in a curved or inclined manner. This can facilitate the assembly of the soft tissue anchoring portion 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 may have a curve or inclination that is steeper than the distal side 616. The proximal side 618 may be configured to provide a mechanical stop between the first end 644 of the proximal head portion of the soft tissue anchoring portion 620 and the detent portion 612. It is contemplated that the detent portion 612 may be configured to deform or bend when a force is applied to the attachment arm 610 to disconnect the soft tissue anchoring portion 620 from the attachment arm 610.

[0200] To assemble the soft tissue anchoring portion 620 with the mounting arm 610, the free end 614 of the mounting arm 610 can be inserted into the passage 642 of the proximal head portion 622 of the soft tissue anchoring portion 620 adjacent to the second end 646 of the soft tissue anchoring portion 620. The mounting arm 610 can be advanced within the passage 642 until the detent 612 is positioned outside the passage 642 adjacent to the first end 644 of the proximal head portion 622. Alternatively, the soft tissue anchoring portion 620 can be advanced relative to the mounting arm 610 until the detent 612 is positioned outside the passage 642 adjacent to the first side of the proximal head portion 622. The passage 642 of the proximal head portion 622 of the soft tissue anchoring portion 620 can have a width 648 greater than the width 650 of the mounting arm 610. The width 648 of the passage 642 may be made greater than the width 650 of the mounting arm 610 such that the soft tissue anchoring portion 620 can freely slide over a portion of the mounting arm 610. Alternatively, the width 648 of the passage 642 can be approximately the same as the width 650 of the mounting arm 610 to provide a friction fit and further secure the soft tissue anchoring portion 620 to the mounting arm 610. The implant 12 can be secured adjacent to the second surface 608 of the frame 600 either simultaneously with or after the assembly of the soft tissue anchoring portion 620 with the frame 600. It is contemplated that the soft tissue anchoring portion 620 can pierce or perforate the implant 12 (see, e.g., FIG. 11B) to secure the implant 12 to the frame 600 for delivery to the target site.

[0201] The frame 600, the implant 12, and the soft tissue anchoring portion 620 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be coupled to the frame 600 and can extend outside the body to facilitate retrieval of the frame 600 when the frame 600 is decoupled from the implant 12. Next, an instrument can be advanced to decouple the soft tissue anchoring portion 620 from the frame 600. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 622 of the soft tissue anchoring portion 620. Next, force can be applied to advance the soft tissue anchoring portion 620 distally such that the distal fixed end 624 or distal tip pierces the tissue. The instrument can be repositioned to align with other soft tissue anchoring portions 620 and force is exerted on the soft tissue anchoring portion 620 to decouple the soft tissue anchoring portion 620 from the frame 600. This can be repeated for each soft tissue anchoring portion 620. Thereby, the clinician can deploy multiple soft tissue anchoring portions 620 without the need to individually attach each soft tissue anchoring portion 620 to the instrument and without the need for repeated insertion and removal of the instrument. Once each soft tissue anchoring portion 620 is driven into the tissue, the frame 600 can be retracted from the body. Retraction of the frame 600 can exert a pulling force on the attachment arm 610, which can further deform by pressing the detent portion 612 against the first end 644 of the proximal head portion 622, whereby the attachment arm 610 can pass through the passage 642 of the proximal head portion 622 of the soft tissue anchoring portion 620, releasing the frame 600 from the soft tissue anchoring portion 620.

[0202] FIG. 12A shows an exploded perspective view of another exemplary attachment arm 710 and soft tissue anchoring portion 720 of frame 700. FIG. 12B is a partial cross-sectional view of an exemplary attachment arm 710 of frame 700 assembled with soft tissue anchoring portion 720 and implant 12. Frame 700 may be similar in form and function to frame 100 described herein. Soft tissue anchoring portion 720 may be configured to be assembled with frame 700 and implant 12 (not explicitly shown) to releasably secure implant 12 to frame 700. Although soft tissue anchoring portion 720 is described in relation to a single attachment arm 710, it should be understood that soft tissue anchoring portion 720 may be provided on any number of attachment arms 710 as desired.

[0203] The soft tissue tether 720 may include a proximal head portion 722 configured to hold down the implant 12, and a distal fixation end 724 configured to penetrate into the tissue. An elongated intermediate connection portion or body 726 may extend between the proximal head portion 722 and the distal fixation end 724. It has been contemplated that the proximal head portion 722 may have a width greater than the width of the intermediate connection portion 726. The proximal head portion 722 has an upper side 734 that faces away from the implant 12 when the implant 12 is attached to the frame 700, a lower side 736 that faces the implant 12 or is juxtaposed with the implant 12 when the implant 12 is attached to the frame 700, a first lateral side 738 that extends between the upper side 734 and the lower side 736, and a second lateral side 740 that extends between the upper side 734 and the lower side 736 and is opposite the first lateral side 738. Collectively, the upper side 734, the lower side 736, the first lateral side 738, and the second lateral side 740 can define a passageway 742 that extends from a first end 744 to a second end 746 of the proximal head portion 722. The passageway 742 can slide the proximal head portion 722 across the attachment arm 710 (as shown in FIG. 12B), while being sized and shaped to prevent the proximal head portion 722 from unintentionally disengaging from the attachment arm 710 prior to assembly with the soft tissue tether 720. A first detent 750a and a second detent 750b (collectively, 750) can extend from the upper side 734 into the passageway 742. The detents 750 can be considered protrusions. Alternatively or additionally, the detents 750 may extend from the lower side 736 (not explicitly shown) and / or the lateral sides 738, 740 into the passageway 742. It has been contemplated that fewer than two (e.g., one) or more than two (e.g., three, four, five, or more) detents 750 can extend from the surface of the proximal head portion 722 into the passageway 742. In other examples, the detents 750 can extend from a protrusion or some other portion of the proximal head portion 722 without extending into the passageway 742. The detents 750 are shown as generally having a hemispherical shape, but it has been contemplated that the detents 750 can take any desired shape, including but not limited to conical, cubic, pyramidal, etc.Furthermore, although the detent portion 750 is shown as being positioned in a linear arrangement, this is not essential. The detent portion 750 can be positioned in any configuration of desired symmetry or asymmetry.

[0204] The distal fixation end 724 may generally be in a “V” shape, or may have a sharp tip, and may include a first engaging portion 728a and a second engaging portion 728b (collectively, 728). The distal fixation end 724 may be shaped such that when the distal fixation end 724 is assembled with the frame 700 and / or body tissue, proximal retraction of the soft tissue anchoring portion 720 is prevented or impeded. For example, each of the engaging portions 728 may include proximal ends 730a, 730b (collectively, 730) radially spaced from the intermediate connecting portion or body 726, and distal ends 732a, 732b (collectively, 732) that are in contact with or connected to the distal fixation end 724. In some cases, fewer than two or more engaging portions 728 may be provided. In some cases, the proximal ends 730 of the engaging portions 728 may be configured to distort radially inward to facilitate distal advancement of the soft tissue anchoring portion 720 through the frame 700, implant 12, and / or body tissue, and to return to a radially expanded outwardly extending configuration (such as the configuration shown in FIG. 12A) after insertion, although this is not essential. The distal fixation end or distal tip of the soft tissue anchoring portion 720 is configured to guide the soft tissue anchoring portion 720 when advanced into body tissue. The engaging portions 728 are angled or inclined such that the soft tissue anchoring portion 720 can be easily advanced distally through tissue, but proximal retraction of the soft tissue anchoring portion 720 is difficult or impossible. This can help ensure that the soft tissue anchoring portion 720 self - anchors when assembled with the frame 700 and / or implant 12 and / or implanted into tissue. The angle and / or length of the engaging portions 728 may be varied. It is contemplated that the engaging portions 728 may have a structure or shape different from an angled surface, including, but not limited to, curvature, steps, etc. It is contemplated that alternative or additional other structural features of the engaging portions 728 may be used to help fix the soft tissue anchoring portion 720 to the frame 700 and implant 12 and / or within the tissue.

[0205] The intermediate connection portion or body 726 can be an elongated bar generally having a cylindrical shape, but can take other shapes as desired. Although the intermediate connection portion or body 726 is shown as generally having a uniform diameter cross-sectional dimension, it is contemplated that the cross-sectional dimension of the intermediate connection portion or body 726 may vary along its length. For example, the intermediate connection portion or body 726 may have a decreasing cross-sectional dimension from the proximal head portion 722 towards the distal fixed end 724. This is merely one example. Other configurations can be used as desired. It is contemplated that the soft tissue anchoring portion 720 may be formed as a single integral structure, or as a series of components fixed to each other, as desired.

[0206] It is further contemplated that the soft tissue anchoring portion 720 can take other configurations. For example, the soft tissue anchoring portion 720 can be a "U"-shaped tissue anchoring portion with hooks similar to a stapler's needle, having two legs extending distally. In such an example, the hooked edge or legs penetrate the tissue and are fixed within the tissue, while the "U" shaped connection portion or bridge provides a passage for engaging with the attachment arm 710 and provides support for holding the implant 12 between the hooked legs. In other embodiments, the soft tissue anchoring portion 720 may have a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for holding the implant. This is merely an example.

[0207] The attachment arm 710 includes a first surface 706 (e.g., the surface facing away from the implant 12) and a second surface 708 (e.g., the surface facing the implant 12) that define a thickness 718 therebetween. The attachment arm 710 can include a first hole or recess 712a positioned adjacent its free end 714 and a second hole or recess 712b (collectively, 712) laterally spaced from the first recess 712a. In some cases, the recesses 712 can extend partially through the thickness 718 of the attachment arm 710. In other cases, the recesses 712 can 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 further contemplated that some recesses 712 extend partially through the thickness 718 while other recesses 712 extend completely through the thickness 718 of the attachment arm 710. The attachment arm 710 can include fewer than two (e.g., one) or more than two (e.g., three, four, five, or more) recesses 712. The recesses 712 are generally shown as hemispherical in order to generally mate with the detents 750, but it is contemplated that the recesses 712 can take any desired shape including, but not limited to, conical, cubic, pyramidal, etc. Further, the recesses 712 are shown as being positioned in a linear arrangement, but this is not essential. The recesses 712 can be positioned in any desired symmetric or asymmetric configuration. It is contemplated that the configuration of the recesses 712 can be a mirror image or match the configuration of the detents 750 at the proximal head portion 722 of the soft tissue tether 720.

[0208] To assemble the soft tissue tether 720 with the mounting arm 710, the free end 714 of the mounting arm 710 can be inserted into the passage 742 of the proximal head portion 722 of the soft tissue tether 720 adjacent to the second end 746 of the soft tissue tether 720. The mounting arm 710 may be advanced in the passage 742 until the retaining portion 750 of the proximal head portion 722 engages the recess 712 of the mounting arm 710. For example, as shown in FIG. 12B, to form a mechanical interlock between the two components, the first retaining portion 750a of the soft tissue tether 720 may be configured to be disposed within or engage the first recess 712a of the mounting arm 710, and the second retaining portion 750b of the soft tissue tether 720 may be configured to be disposed within or engage the second recess 712b of the mounting arm 710. The passage 742 of the proximal head portion 722 of the soft tissue tether 720 can have a width 748 that is greater than the width 716 of the mounting arm 710. The width 748 of the passage 742 may be made greater than the width 716 of the mounting arm 710 such that the soft tissue tether 720 can slide freely over a portion of the mounting arm 710. Alternatively, the width 748 of the passage 742 may be approximately the same as the width 716 of the mounting arm 710 to provide a friction fit and further secure the soft tissue tether 720 to the mounting arm 710. The implant 12 can be secured adjacent to the second surface 708 of the frame 700 either simultaneously with or after the assembly of the soft tissue tether 720 with the frame 700. It is contemplated that the implant 12 can be stabbed or perforated (see, e.g., FIG. 12B) to secure the soft tissue tether 720, the implant 12 to the frame 700.

[0209] Positioning the detent 750 and the recess 712 at staggered positions with respect to the width 748 of the passage 742 and the width 716 of the mounting arm 710 can help facilitate assembly by preventing the detent (e.g., detent 750b) from engaging prematurely with a recess (e.g., recess 712a) intended for a different detent (e.g., detent 750a), although this is not essential. For example, the first recess 712a may be laterally offset from the longitudinal axis 702 of the mounting arm 710 in a first direction, and the second recess 712b may be laterally offset from the longitudinal axis 702 of the mounting arm 710 in a second direction opposite the first direction. The corresponding detents 750 in the proximal head portion 722 may be similarly arranged so that the detents 750 can be assembled with the recesses 712.

[0210] Frame 700, implant 12, and soft tissue anchoring portion 720 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be coupled to the frame 700 and can extend out of the body to facilitate retrieval of the frame 700 when the frame 700 is decoupled from the implant 12. Next, an instrument can be advanced to decouple the soft tissue anchoring portion 720 from the frame 700. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 722 of the soft tissue anchoring portion 720. Next, a force can be applied to advance the soft tissue anchoring portion 720 distally such that the distal fixed end 724 or distal tip pierces the tissue. The instrument can be repositioned to align with other soft tissue anchoring portions 720, and a force is exerted on the soft tissue anchoring portion 720 to decouple the soft tissue anchoring portion 720 from the frame 700. This can be repeated for each soft tissue anchoring portion 720. Thereby, the clinician can deploy multiple soft tissue anchoring portions 720 without the need to individually attach each soft tissue anchoring portion 720 to the instrument and without the need for repeated insertion and removal of the instrument. Once each soft tissue anchoring portion 720 is driven into the tissue, the frame 700 can be retracted from the body. Retraction of the frame 700 can exert a pulling force on 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 passageway 742 of the proximal head portion 722 of the soft tissue anchoring portion 720 and releasing the frame 700 from the soft tissue anchoring portion 720.

[0211] FIG. 13A shows a perspective view of another exemplary attachment arm 810 of frame 800 and a soft tissue anchoring portion 820 to which implant 12 is attached. FIG. 13B is an exploded perspective view of an exemplary attachment arm 810, a retainer 840, and an exemplary soft tissue anchoring portion 820 of frame 800 of FIG. 13A. Frame 800 may be similar in form and function to frame 100 described herein. Soft tissue anchoring portion 820 may be configured to be assembled with frame 800 and implant 12 to releasably secure the implant to frame 800. FIG. 13C is a cross-sectional view of an exemplary attachment arm 810 taken along line 13C-13C of FIG. 13A. Although soft tissue anchoring portion 820 is described in relation to a single attachment arm 810, it should be understood that soft tissue anchoring portion 820 may be provided on any number of attachment arms 810 as desired.

[0212] In the exemplary embodiments of FIGS. 13A-13C, soft tissue anchoring portion 820 may be removably coupled to attachment arm 810 via retainer 840. Retainer 840 may be configured to slide over free end 814 of attachment arm 810. Generally, soft tissue anchoring portion 820 can be advanced through an opening 842 in retainer 840 and an opening 812 in attachment arm 810. Retainer 840 may include features configured to engage mating features of soft tissue anchoring portion 820 to releasably secure soft tissue anchoring portion 820, although this is not essential.

[0213] The soft tissue anchoring portion 820 may include a proximal head portion 822 configured to hold down the implant 12 and a distal fixation end 824 configured to pierce the tissue. An elongated intermediate connection portion 826 may extend between the proximal head portion 822 and the distal fixation end 824. In some examples, the proximal head portion 822 may include two or more or a plurality of inclined surfaces. The proximal head portion 822 may take the form of a frustum of a pyramid. The proximal head portion 822 may have an upper surface 821 and a lower surface 823. The upper surface 821 may have a length 833 and a width 835 that are larger than those of the lower surface 823, but this is not essential. The lower surface 823 may be connected to the intermediate connection portion 826 or may be positioned adjacent to the intermediate connection portion 826. The proximal head portion 822 may further include a first lateral surface 825, a second lateral surface 827 opposite the first lateral surface 825, a third lateral surface 829, and a fourth lateral surface 831 opposite the third lateral surface 829. In some examples, the lateral surfaces may be inclined surfaces that are acute angles with respect to the insertion direction of the soft tissue anchoring portion 820. The proximal head portion 822 may take other shapes as desired, such as, but not limited to, a rectangular prism, a cube, an ellipsoid, etc.

[0214] The distal fixation end 824 can have a "U" shape with a hanging portion including a first leg 834a and a second leg 834b (collectively, 834) extending from the intermediate connection portion 826. The legs 834 can be laterally spaced so as to define a passage 836 therebetween. The first leg 834a can comprise a distal tip including a first hanging portion 828a, and the second leg 834b can comprise a distal tip including a second hanging portion 828b (collectively, 828). The distal fixation end 824 can be shaped such that when the distal fixation end 824 is assembled with the frame 800 and / or body tissue, proximal retraction of the soft tissue anchoring portion 820 is prevented or obstructed. For example, each of the hanging portions 828 can comprise proximal ends 830a, 830b (collectively, 830) radially spaced from their respective legs 834, and distal ends 832a, 832b (collectively, 832) in contact with or connected to the distal fixation end 824. In some cases, fewer than two or more hanging portions 828 may be provided. In some cases, the proximal ends 830 of the hanging portions 828 can be configured to distort radially inwardly to facilitate distal advancement of the soft tissue anchoring portion 820 through the frame 800, the retainer 840, the implant 12, and / or body tissue, and to return to a radially outwardly extending configuration (such as the configuration shown in FIGS. 13B and 13C) after insertion, although this is not essential. The distal fixation end or distal tip of the leg 834 of the soft tissue anchoring portion 820 is configured to lead the soft tissue anchoring portion 820 when advanced into body tissue. The hanging portions 828 are angled or inclined such that the soft tissue anchoring portion 820 can be easily advanced distally through tissue, but proximal retraction of the soft tissue anchoring portion 820 is made difficult or impossible. This can help ensure that the soft tissue anchoring portion 820 self-anchors when assembled with the frame 800 and / or implant 12 and / or implanted into tissue. The angle and / or length of the hanging portions 828 can be varied. It is contemplated that the hanging portions 828 can have a structure or shape different from an angled surface, including but not limited to curvature, steps, etc.It is contemplated that alternative or additional other structural features of the engaging portion 828 may be used to assist in securing the soft tissue anchoring portion 820 to the frame 800 and the implant 12 and / or into the tissue.

[0215] The elongate intermediate connecting portion 826 can connect the proximal head portion 822 and the distal fixed end 824. In some cases, the intermediate connecting portion 826 can form a bridging portion between the first leg portion 834a and the second leg portion 834b. It is contemplated that the soft tissue anchoring portion 820 may be formed as a single integral structure or a series of components fixed to each other as desired.

[0216] It is further contemplated that the soft tissue anchoring portion 820 can take other configurations. For example, the soft tissue anchoring portion 820 can be any of the soft tissue anchoring portions described herein. In other embodiments, the soft tissue anchoring portion 820 can be a screw having a threaded distal end region. The threaded region can penetrate the tissue while the head of the screw provides support for pressing against the implant. This is merely an example.

[0217] The attachment arm 810 can include an opening 812 configured to receive a portion of the soft tissue anchoring portion 820. The opening 812 can have a rectangular cross-sectional shape similar to the approximate cross-sectional shape of the proximal head portion 822 of the soft tissue anchoring portion 820 and can extend through the thickness of the attachment arm 810 from a first surface 806 (e.g., a first surface facing away from the target site in the body) that faces away from the implant 12 when the implant 12 is attached to the frame 800 and a second surface 808 (e.g., a second surface facing the target site in the body) that faces the exemplary implant 12. The opening 812 can be sized and shaped to allow the proximal head portion 822 of the soft tissue anchoring portion 820 to pass through the opening 812. For example, the opening 812 can have a width 816 greater than the width 835 of the proximal head portion 822 and a length 818 greater than the length 833 of the proximal head portion 822.

[0218] The retainer 840 can include an upper side 844 that faces away from the implant 12 when the implant 12 is attached to the frame 800, a lower side 846 that faces the implant 12 when the implant 12 is attached to the frame 800, a first lateral side 848 that extends between the upper side 844 and the lower side 846, and a second lateral side 850 that extends between the upper side 844 and the lower side 846 and is opposite the first lateral side. Collectively, the upper side 844, the lower side 846, the first lateral side 848, and the second lateral side 850 can define a passageway 852 that extends from a first end 854 to a second end 856 of the retainer 840. The passageway 852 can be sized and shaped such that the retainer 840 can be slid across the attachment arm 810 (as shown in FIG. 13A), while preventing the retainer 840 from inadvertently disengaging from the attachment arm 810 prior to assembly with the soft tissue anchoring portion 820. The retainer 840 can further include a first opening 858 in the upper side 844 and a second opening 860 defined in the lower side 846. The first opening 858 and the second opening 860 can have a rectangular cross-sectional shape similar to the approximate cross-sectional shape of the proximal head portion 822 of the soft tissue anchoring portion 820, although this is not essential. The first opening 858 and the second opening 860 can generally be aligned to define an opening 842 that extends from the upper side 844 to the lower side 846. The first opening 858 and the second opening 860 can have the same diameter, the same diameter, or different diameters, as desired. In some embodiments, the first opening 858 can have a width 862 that is smaller than the width 835 of the proximal head portion 822 and a length 864 that is smaller than the length 833 of the proximal head portion 822, and the second opening 860 can have a width that is larger than the width 835 of the proximal head portion 822 and a length that is larger than the length 833 of the proximal head portion 822.

[0219] To assemble the soft tissue anchoring portion 820 with the mounting arm 810, the holder 840 can be advanced across the free end 814 of the mounting arm 810 until the opening 842 of the holder 840 is roughly aligned with the opening 812 of the mounting arm 810. Next, the distal fixed end 824 of the soft tissue anchoring portion 820 can be advanced through the openings 812, 842 in a direction from the upper side 844 to the lower side 846 of the holder 840. The soft tissue anchoring portion 820 can be advanced until the first surface 825, the second surface 827, the third surface 829, and the fourth surface 831 engage the side walls of the first opening 858 in the holder 840. The surfaces 825, 827, 829, 831 can form a friction fit with the first opening 858 such that a first force fixes the soft tissue anchoring portion 820 within the first opening 858 and a second force greater than the first force presses the soft tissue anchoring portion 820 through the first opening 858, the opening 842, and the second opening 860. It is contemplated that during assembly, the implant 12 can be positioned adjacent to the second surface 808 of the frame 800 and / or the lower side 846 of the holder 840 such that the soft tissue anchoring portion 820 pierces the implant 12 and secures the implant 12 to the frame 800.

[0220] The frame 800, the implant 12, and the soft tissue anchoring portion 820 can be delivered to the body using a delivery system and method similar to those previously described with respect to FIGS. 2-4. The implant 12 can be temporarily fixed using a bone tack or the like when positioned at the target location. The delivery system can be released from the portal and retracted to allow insertion of other devices. In some cases, a tether may be connected to the frame 800 and can extend outside the body to facilitate recovery of the frame 800 when it is disconnected from the implant 12. Next, an instrument can be advanced to disconnect the soft tissue anchoring portion 820 from the frame 800. In some cases, the instrument can be similar to a punch-type instrument, but this is not essential. The instrument can be aligned with the proximal head portion 822 of the soft tissue anchoring portion 820. Next, a force can be applied to advance the soft tissue anchoring portion 820 distally such that the distal fixed end 824 or distal tip of the leg pierces the tissue. It is contemplated that when a force is applied to the proximal head portion 822, the upper side 844 of the retainer 840 can bend, distort, deform, or break, allowing the proximal head portion 822 to pass through or disengage from the first opening 858. In some cases, the angled or slanted surfaces of the first surface 825, the second surface 827, the third surface 829, and the fourth surface 831 can facilitate passage of the proximal head portion 822 through the first opening 858. As previously described, the second opening 860 can be sized such that the proximal head portion 822 can easily pass through, but this is not essential. The instrument can be repositioned to align with other soft tissue anchoring portions 820, and a force is exerted on the soft tissue anchoring portion 820 to disconnect it from the frame 800. This can be repeated for each soft tissue anchoring portion 820. Thereby, the clinician can deploy multiple soft tissue anchoring portions 820 without the need to individually attach each soft tissue anchoring portion 820 to the instrument and without the need for repeated insertion and removal of the instrument.

[0221] It should be understood that the present disclosure is merely illustrative in many respects. Changes can be made in detail, particularly as to the shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This can include the use of any of the features of one exemplary embodiment in other embodiments, as appropriate. The scope of the present disclosure is, of course, defined by the words in which the appended claims are expressed.

Explanation of Reference Numerals

[0222] 10 Shoulder 12 Tendon repair implant 14 Head 16 Humerus 18 Glenoid fossa 20 Scapula 22 Supraspinatus tendon 24 Distal tendon 26 Insertion point 28 Damaged part 30 Laceration 40 Implant delivery system 42 Sheath member, cannula 44 Delivery shaft 46 Frame member 48 Distal portion, distal end of sheath member 42 50 Distal portion, distal end of delivery shaft 44 52 Proximal end 54 Distal end, distal portion 58 Head portion 60 Opening 64 Mounting arm 68 Distal portion, distal end 70 Mounting opening 76 Mounting member 80 Spiral pattern, spiral portion 81 Spiral 82 Second spiral 84 Lumen 88 Connection assembly 90 First connection member 92 Second connection member 100 Frame member 102 Proximal end 104 Distal end 106 First surface 108 Second surface, lower side 110, 110a, 110b, 110c, 110d, 110e, 110f Mounting arm 114a Recess 116a Thickness of mounting arm 110a 118a Thickness reduction region 120, 120a, 120b, 120c, 120d, 120e, 120f Soft tissue tethering part 122 Proximal head part 124 Distal fixed end 126 Intermediate connection part, body 128, 128a, 128b Hanging part 130, 130a, 130b Proximal end 132a, 132b Distal end 200 Frame 206 First surface 208 Second surface 210 Mounting arm 214 Opening 216 Circumferential groove 218, 218a, 218b Axially extending slot 220 Soft tissue tethering part 222 Proximal head part 224 Distal fixed end 226 Intermediate connection part, body 228, 228a, 228b Hanging part 230, 230a, 230b Proximal end 232, 232a, 232b Distal end 234, 234a, 234b Protrusion 236 Cross-sectional dimension of proximal head part without protrusion 234 238 Cross-sectional dimension of proximal head part with protrusion 234, main cross-sectional dimension 300 Frame 310 Mounting arm 314 Opening 316 Diameter of opening 314 320, 320´ Soft tissue tethering part 322 Proximal head part, proximal head region 324 Distal fixed end 326 Intermediate connection part, body 328, 328a, 328b Hanging part 330, 330a, 330b Proximal end 332, 332a, 332b Distal end 334 Periphery, retaining part 336 Diameter of proximal head part 322 338 Maximum diameter of proximal head part 322 340 Retaining body 342 Opening 344 Upper side 346 Lower side 348 First lateral side 350 Second lateral side 352 Passageway 354 First end 356 Second end 358 First opening 360 Second opening 362 Fitting recess 370 Retaining body 372 Upper surface, upper side 374 Lower side 376 First lateral side 378 Second lateral side 380 Passageway 382 First end 384 Second end 386 First opening 388 Second opening 390 Opening 392 Diameter of openings 386, 388 394 Predetermined location 400 Frame 406 First surface, upper surface 408 Second surface, lower surface 410 Mounting arm 412, 412a, 412b Flexible arm 414 Distal opening 416 Opening 418 First width, width of distal opening 414 420, 420´ Soft tissue tethering part 422 Proximal head part 424 Distal fixed end 426 Intermediate connection part, body 428, 428a, 428b Hanging parts 430, 430a, 430b Proximal end 432, 432a, 432b Distal end 434 Diameter of the intermediate connection part 426 436 Width or diameter of the proximal head part 422 440 Width, diameter of the opening 416 442, 442a, 442b Bending direction, outward of the flexible arm 412 450 Recess 452 Height of the recess 450 500 Frame 504 Longitudinal axis 508 Second surface 510 Mounting arm 511, 511a, 511b Proximal part 512, 512a, 512b Flexible arms 513, 513a, 513b Distal part 514, 514a, 514b Free ends 516 Gap 518 Strain relief notch 520 Soft tissue anchoring part 522 Proximal head part 524 Distal fixed end 526 Intermediate connection part, body 528, 528a, 528b Hanging parts 530, 530a, 530b Proximal end 532, 532a, 532b Distal end 534 Upper side 536 Lower side 538 First lateral side 540 Second lateral side 542 Passageway 548 Width of the passageway 542 550, 550a, 550b Inward bending of the flexible arm 512 552 Width of the mounting arm 510 at the free end 514 554 Width of the flexible arm at the proximal part 511 600 Frame 606 First surface 608 Second surface 610 Mounting arm 612 Raised detent portion 614 Free end 616 Distal side 618 Proximal side 620 Soft tissue anchoring portion 622 Proximal head portion 624 Distal fixed end 626 Intermediate connection portion, trunk 628, 628a, 628b Hanging portion 630, 630a, 630b Proximal end 632, 632a, 632b Distal end 634 Upper side 636 Lower side 638 First lateral side 640 Second lateral side 642 Passageway 644 First end 646 Second end 648 Width of passageway 642 650 Width of mounting arm 610 700 Frame 702 Longitudinal axis 706 First surface 708 Second surface 710 Mounting arm 712, 712a, 712b Hole, recess 716 Width of mounting arm 710 718 Thickness of mounting arm 710 720 Soft tissue anchoring portion 722 Proximal head portion 724 Distal fixed end 728, 728a, 728b Hanging portion 734 Upper side 736 Lower side 738 First lateral side 740 Second lateral side 742 Passageway 744 First end 746 Second end 748 Width of passageway 742 750, 750a, 750b Return stop parts 800 Frame 806 First surface 808 Second surface 810 Mounting arm 812 Opening 814 Free end 816 Width of opening 812 818 Length of opening 812 820 Soft tissue tethering part 821 Upper surface 822 Proximal head portion 823 Lower surface 824 Distal fixed end 825 First lateral side 826 Intermediate connection part 827 Second lateral side 828, 828a, 828b Hanging parts 829 Third lateral side 830, 830a, 830b Proximal end 831 Fourth lateral side 832, 832a, 832b Distal end 833 Length of upper surface 821, length of proximal head portion 822 834, 834a, 834b Leg parts 835 Width of upper surface 821, width of proximal head portion 822 836 Passageway 840 Retaining body 842 Opening 844 Upper side 846 Lower side 848 First lateral side 850 Second lateral side 852 Passageway 854 First end 856 Second end 858 First opening 860 Second opening 862 Width of first opening 858 864 Length of first opening 858

Claims

1. A delivery shaft including a proximal portion and a distal portion, A frame coupled to the distal portion of the delivery shaft, the frame including a body portion and a plurality of mounting arms extending away from the body portion, At least one soft tissue anchor releasably fixed to a free end of at least one of the plurality of mounting arms, An implant releasably fixed to the frame via the at least one soft tissue anchor, An implant delivery system comprising.

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

3. The implant delivery system according to claim 1 or 2, wherein the at least one tissue anchor comprises a proximal head portion, a distal fixed end, and an intermediate connecting portion extending between the proximal head portion and the distal fixed end.

4. The implant delivery system according to claim 3, wherein the proximal head portion is generally disc-shaped.

5. The implant delivery system according to claim 3 or 4, wherein the distal fixed end comprises a first hook portion and a second hook portion.

6. The implant delivery system according to any one of claims 3 to 5, wherein the intermediate connecting portion comprises a long bar.

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

8. The implant delivery system according to claim 7, wherein the recess extends partially through the thickness of the at least one of the plurality of mounting arms to define a reduced thickness region.

9. The implant delivery system according to claim 8, further comprising a through hole extending through the thickness reduction region.

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

11. The implant delivery system according to claim 9 or 10, wherein the intermediate connection portion extends through the through hole.

12. Under an applied force, the proximal head portion of the at least one soft tissue anchoring portion is configured to be pushed through the at least one thickness reduction region of the plurality of mounting arms to release the at least one soft tissue anchoring portion from the frame. The implant delivery system according to any one of claims 9 to 11.

13. The implant delivery system according to claim 12, wherein the thickness reduction region is configured to break.

14. The implant delivery system according to claim 12, wherein the thickness reduction region is configured to deform to allow the proximal head portion to pass through the through hole.

15. The implant delivery system according to any one of claims 3 to 6, wherein the proximal head portion further comprises one or more protrusions extending radially.

16. The implant delivery system according to claim 15, further comprising an opening formed adjacent to the free end thereof through at least one of the plurality of mounting arms.

17. The implant delivery system according to claim 16, wherein the opening extends through the thickness of at least one of the plurality of mounting arms.

18. A circumferentially extending groove formed in a side wall of the opening, the circumferentially extending groove being positioned between at least one first surface of the plurality of mounting arms and at least one second surface of the plurality of mounting arms, the implant delivery system according to claim 16 or 17, further comprising a circumferentially extending groove.

19. At least one axially extending slot formed in a side wall of the opening, the implant delivery system according to claim 18, further comprising at least one axially extending slot extending from at least one of the second surfaces of the plurality of mounting arms to the circumferentially extending groove.

20. During assembly of at least one of the at least one soft tissue anchoring portion with at least one of the plurality of mounting arms and during deployment of at least one of the at least one soft tissue anchoring portion from at least one of the plurality of mounting arms, the one or more radially extending protrusions are configured to slide within at least one axially extending slot, the implant delivery system according to claim 19.

21. The one or more radially extending protrusions are rotatably disposed within the circumferentially extending groove during delivery of the implant to a target location, the implant delivery system according to claim 18 or 19.

22. The proximal head portion further comprises one or more radially extending retaining portions, the implant delivery system according to any one of claims 3 to 6.

23. The retaining portion extends around the proximal head portion, the implant delivery system according to claim 22.

24. The implant delivery system according to claim 22 or 23, further comprising an opening formed adjacent to the free end thereof through at least one of the plurality of mounting arms.

25. The implant delivery system according to claim 24, wherein the opening extends through the thickness of at least one of the plurality of mounting arms. **Claim 26** The implant delivery system according to claim 24 or 25, further comprising a retainer configured to slide over a free end of at least one of the plurality of mounting arms. **Claim 27** The implant delivery system according to claim 26, wherein the retainer includes an upper side, a lower side, a first lateral side extending between the upper side and the lower side, and a second lateral side extending between the upper side and the lower side and opposite the first lateral side. **Claim 28** The upper side, the lower side, the first lateral side, and the second lateral side collectively define a passage extending from a first end to a second end of the retainer, and the passage is configured to receive at least one of the plurality of mounting arms. The implant delivery system according to claim 27. **Claim 29** The implant delivery system according to claim 27 or 28, further comprising a first opening in the upper side of the retainer and a second opening defined in the lower side of the retainer, the first opening having a first diameter, the second opening having a second diameter, and the second diameter being larger than the first diameter. **Claim 30** The first opening and the second opening of the retainer are aligned with the opening of at least one of the plurality of mounting arms, and one or more detents extending in the radial direction of the proximal head portion are received in a fitting recess formed in a side wall of the first opening of the retainer. The implant delivery system according to claim 29.

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