Medical implant delivery system

Abstract

Implant delivery systems are disclosed. One implant delivery system includes an outer shaft, an inner shaft movable within the outer shaft, a yoke coupled to a distal end of the inner shaft, and an implant holder pivotably coupled to the yoke. The implant holder is configured to hold a sheet-shaped implant for implantation at a treatment site. Another implant delivery system includes a handle, a delivery sleeve extending from the handle, and a delivery shaft extending through the delivery sleeve to a frame attachable to a sheet-shaped implant. A tether extends from the frame within an inner lumen of the delivery shaft. An actuation member is translatable within a channel of the handle to deploy the frame from the delivery sleeve. A tether clamp positioned within the handle is manipulatable by the actuation member to selectively unlock the tether within the handle.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 004,638, filed April 3, 2020, entitled “Pivot Center Beam for Next-Generation Stent Delivery” and U.S. Provisional Patent Application Serial No. 63 / 004,667, filed April 3, 2020, entitled “Rotation Locking / Unlocking Mechanism for Arthroscopic Delivery Device”, the disclosures of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to, but is not limited to, orthopedic implants, implant delivery systems, and methods of treatment. More specifically, this disclosure relates to a tendon repair implant delivery device for arthroscopic placement of a sheet-like tissue implant above or in the area above or in the region of a tear in all or part of the thickness of a tendon (such as the supraspinatus tendon of the shoulder). Background Technology

[0004] Due to their complexity, range of motion, and widespread use, common soft tissue injuries involve the rotator cuff or rotator cuff tendon. Rotator cuff injuries are potentially serious pathological conditions that can occur during hyperextension due to acute traumatic tears or overuse of the joint. There is a continuing need for arthroscopic procedures to deliver and adequately position medical implants to treat rotator cuff, rotator cuff tendon, or other soft tissue or tendon injuries throughout the body. Summary of the Invention

[0005] This disclosure provides designs, materials, manufacturing methods, and alternatives for use in medical devices.

[0006] A first example includes an implant delivery system. The implant delivery system includes an outer shaft having a proximal end, a distal end, and an inner lumen extending therein. The implant delivery system also includes an inner shaft having a proximal end and a distal end. The inner shaft extends within at least a portion of the inner lumen of the outer shaft. A yoke is coupled to the distal end of the inner shaft. An implant retainer is coupled to the yoke. The implant retainer is configured to capture an implant. The implant retainer is configured to pivot relative to the yoke.

[0007] In addition to, or in any of the above examples, the implant delivery system also includes a spring component that connects both the yoke and the implant retainer.

[0008] In addition, or in any of the above examples, the spring component includes a first end and a second end, wherein the first end is fixedly attached to the yoke, and wherein the second end extends away from the yoke and is positioned inside an inner hole located on the implant retainer.

[0009] In addition, or in any of the above examples, the spring component includes a first end and a second end, wherein the first end is fixedly attached to the implant retainer, and wherein the second end extends away from the implant retainer and is positioned inside an inner hole in the yoke.

[0010] In addition, or in any of the above examples, the spring component is configured to buckle between a first position in which it is aligned with the longitudinal axis of the yoke and a second position in which it is offset from the longitudinal axis of the yoke.

[0011] In addition, or in any of the above examples, the spring component is configured to shift the implant retainer to a second position after the implant has been placed from the inner cavity of the outer shaft.

[0012] In addition to or other than any of the above examples, the implant retainer includes an upper beam connected to the lower beam, and wherein the implant is captured between the upper beam and the lower beam.

[0013] In addition, or in any of the above examples, the lower beam includes a spring member connected to the upper beam, wherein the spring member includes a proximal end that extends into a hole in the yoke.

[0014] In addition, or in any of the above examples, the yoke includes a first longitudinal arm spaced apart from the second longitudinal arm, wherein the first longitudinal arm includes a first groove (configured to receive a first protrusion positioned on the implant retainer), and wherein the second longitudinal arm includes a second groove (configured to receive a second protrusion positioned on the implant retainer).

[0015] In addition, or except for any of the above examples, the first protrusion is configured to pivot within the first groove and the second protrusion is configured to pivot within the second groove.

[0016] Another example includes an implant delivery system. The implant delivery system includes a handle having a distal region, a proximal region, and a channel extending from the distal region to the proximal region. A delivery cannula extends distally from the handle. The delivery cannula has an endometrium extending to the distal end of the delivery cannula. A delivery shaft is positioned within the endometrium of the delivery cannula. The delivery shaft has a distal end, a proximal end, and an endometrium extending therein. A frame is coupled to the distal end of the delivery shaft. The frame can be attached to a sheet-like implant. An actuating member can translate within the channel to place the frame from the delivery cannula. A tether extends from at least a portion of the frame and the handle within the endometrium of the delivery shaft. A tether clamp is positioned within the handle. The tether clamp can be actuated by the actuating member to selectively unlock the tether within the handle.

[0017] In addition, or in any of the above examples, unlocking the tether clamp allows the tether to translate relative to the handle, the conveyor shaft, or both the handle and the conveyor shaft.

[0018] In addition, or in any of the above examples, translating the actuating member from the distal region of the channel to the proximal region of the channel causes the delivery sleeve to shift from a first position to a second position relative to the delivery shaft in the proximal direction.

[0019] In addition to or other than any of the above examples, the tether clamp includes a locking lever that is designed to rotate between a first position in which the locking lever locks the tether to the handle and a second position in which the tether translates freely relative to the handle.

[0020] In addition to or in addition to any of the above examples, the actuating member also includes an engaging member configured to engage with the locking lever, and wherein rotation of the actuating member causes the engaging member to engage with the locking lever, such that the locking lever rotates from a first position in which the locking lever locks the tether to the handle to a second position in which the tether translates freely relative to the handle.

[0021] In addition to or other than any of the above examples, the tether clamp includes a movable part positioned adjacent to the fixed part, wherein the movable part is designed to move between a first position in which the tether is locked between the movable part and the fixed part and a second position in which the tether is freely translated relative to the movable part and the fixed part.

[0022] In addition to, or in any of the examples described above, a spring is attached to a moving part. The spring is configured to apply force to the moving part to lock the tether between the moving part and the stationary part.

[0023] In addition to or in addition to any of the above examples, the actuating member also includes an engaging member configured to engage with the moving member, and wherein rotation of the actuating member causes the engaging member to engage with the moving member, such that the moving member translates between a first position in which the moving member locks the tether to the handle and a second position in which the tether is freely translated relative to the moving member and the fixed member.

[0024] In addition to or besides any of the examples described above, the tether clamp includes a locking block having a groove extending between adjacent first and second sidewalls through which the tether extends, and an engagement feature designed to engage with a mating engagement feature of an actuating member. The first sidewall of the locking block is configured to move relative to the second sidewall of the locking block between a first position in which the tether is pressed between the first and second sidewalls and a second position in which the tether translates freely within the groove.

[0025] In addition, or in any of the above examples, rotation of the actuating member causes the first sidewall to rotate between a first position in which the tether is locked inside the groove of the locking block and a second position in which the tether translates freely inside the groove.

[0026] The above overview of some implementations is not intended to describe all implementations or every embodiment of this disclosure. The following figures and detailed description illustrate these implementations in more specific terms. Attached Figure Description

[0027] This disclosure will be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, wherein:

[0028] Figure 1 An exemplary implant delivery system is shown;

[0029] Figure 2 The shoulder is shown, which includes the humeral head that pairs with the glenoid fossa of the scapula at the glenohumeral joint and an implant attached to the tendon using an implant delivery device;

[0030] Figure 3 An exemplary implant attached to an implant delivery device is shown;

[0031] Figure 4 It shows Figure 3 An exploded view of a portion of the implant delivery device shown;

[0032] Figure 5 It shows along Figure 3 The sectional view intercepted by line 5-5;

[0033] Figure 6 An exemplary implant delivery device in a first position is shown;

[0034] Figure 7 It shows the second position. Figure 6 Implant delivery device;

[0035] Figure 8 Another implant delivery device is shown in the first position;

[0036] Figure 9 It shows the second position. Figure 8 Implant delivery device;

[0037] Figure 10 Another implant delivery device attached to the exemplary implant delivery system is shown;

[0038] Figure 11 This is a perspective view of another implant delivery system;

[0039] Figure 12 yes Figure 11 Another perspective view of the exemplary implant delivery system shown;

[0040] Figure 13 yes Figure 12An exploded view of the exemplary implant delivery system shown;

[0041] Figure 14 yes Figure 11 Another perspective view of the exemplary implant delivery system shown;

[0042] Figure 15 yes Figure 14 An exploded view of the exemplary implant delivery system shown;

[0043] Figure 16 yes Figure 15 A schematic end view of the implant delivery system shown;

[0044] Figure 17 yes Figure 11 Another perspective view of the exemplary implant delivery system shown;

[0045] Figure 18 yes Figure 17 A schematic end view of the implant delivery system shown;

[0046] Figure 19 This is an exploded view of another exemplary implant delivery system;

[0047] Figure 20 yes Figure 19 A schematic end view of the implant delivery system shown;

[0048] Figure 21 It is in the second position. Figure 19 A schematic end view of the implant delivery system shown;

[0049] Figure 22 This is an exploded view of another implant delivery system;

[0050] Figure 23 yes Figure 22 Another exploded view of the implant delivery system shown;

[0051] Figure 24 yes Figure 23 A schematic end view of the implant delivery system shown;

[0052] Figure 25 It is in the second position. Figure 24 A schematic end view of the implant delivery system shown.

[0053] While this disclosure may have various modifications and alternatives, its details have been revealed by example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to encompass all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0054] For the purposes of the terms defined below, these definitions shall apply unless otherwise given in the claims or elsewhere in this specification.

[0055] All numerical assumptions in this document are modified by the word “approximately”, whether explicitly stated or not. The word “approximately” generally refers to a series of numbers that a person skilled in the art would consider equivalent to the listed values ​​(e.g., having the same function or result). In many cases, the word “approximately” may include numbers rounded to the nearest significant figure.

[0056] Statements of numerical ranges using endpoints include all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0057] The singular forms “a,” “an,” and “the” used in this specification and the appended claims include the plural objects referred to, unless the context otherwise requires. The word “or” used in this specification and the appended claims is generally used to include its meaning of “and / or,” unless the context otherwise expressly provides.

[0058] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in this specification indicate that the described embodiment may include one or more specific features, structures, and / or characteristics. However, such statements do not necessarily mean that all embodiments include that specific feature, structure, and / or characteristic. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in conjunction with other embodiments, whether explicitly stated or not, unless the contrary is explicitly stated.

[0059] The following detailed description should be read with reference to the accompanying drawings, in which similar elements are labeled with the same reference numerals in different drawings. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of this disclosure.

[0060] Due to their complexity, range of motion, and widespread use, common soft tissue injuries involve the rotator cuff or rotator cuff tendon. Rotator cuff injuries are potentially serious pathological conditions that occur during hyperextension due to acute traumatic tears or overuse of the joint. Approved treatment for rotator cuff tears may include reattaching the torn tendon to the humeral head using sutures. Furthermore, approved practices in the treatment of rotator cuff tears may also include placing a brace over the repaired tendon to mechanically reinforce the repaired tendon and / or promote tissue remodeling. Therefore, there is a continuing need for the delivery and adequate positioning of medical implants during arthroscopic surgery to treat injuries to the rotator cuff, rotator cuff tendon, or other soft tissue or tendon injuries throughout the body.

[0061] Figure 1 An exemplary implant delivery system 10 is shown. This exemplary implant delivery system 10 may include a handle 12 having a trigger 14. Furthermore, the implant delivery system 10 may include an outer shaft 16 coupled to the handle 12. Figure 1 An implant delivery system 10 is shown, which may include an inner shaft 18 extending within an outer shaft 16. The implant delivery system 10 may also include an implant delivery device assembly 20 coupled to a distal region of the inner shaft 18 via a yoke 26. The implant delivery device assembly 20 may include a rotating arm 25 coupled to an implant 24.

[0062] The outer shaft 16 of the implant delivery system 10 may include a proximal end (attached to the handle 12), a distal end, and an inner cavity extending within at least a portion of the outer shaft 16. In some embodiments, the distal end of the outer shaft 16 may be attached to a delivery cannula 34. In other words, the delivery cannula 34 may extend away from the distal end of the outer shaft 16, thereby allowing the distal end of the outer shaft 16 to be attached to the proximal end of the delivery cannula 34. In some embodiments, the delivery cannula 34 may resemble a generally cylindrical cannula, a portion of which may be secondary-formed onto the distal end of the outer shaft 16. The delivery cannula 34 may be designed to accommodate the implant delivery device assembly 20 (including the implant 24) in a rolling, folded, or retracted delivery state as the implant delivery system 10 approaches the target site.

[0063] For clarity, Figure 1 An implant delivery device assembly 20 extending from the distal end of the delivery cannula 34 is shown. It will be understood that the implant delivery device assembly 20 may be located within the lumen of the delivery cannula 34 before being placed from the distal end of the delivery cannula 34. For example, the implant delivery device assembly 20 (including the implant 24) may be positioned within the lumen of the delivery cannula 34 in a rolling, folding, or collapsing delivery configuration while being tracked to the target site.

[0064] It is also understood that actuation of trigger 14 can move shaft 16 relative to both implant assembly 20 and inner shaft 18. For example, actuation of trigger 14 can move outer shaft 16 between a first position in which implant assembly 20 is positioned inside the lumen of delivery cannula 34 and a second position in which outer shaft 16 is retracted proximally relative to inner shaft 18, thereby placing implant assembly 20 from the distal region of delivery cannula 34. The individual components of implant assembly 20 will be described in more detail below.

[0065] Figure 2 A cross-sectional view of shoulder 28 is shown. Shoulder 28 shows the head 30 of humerus 32, which mates with the glenoid fossa 35 of scapula 36. The glenoid fossa 35 includes a shallow depression within scapula 36. The supraspinatus tendon 38 is also shown. These muscles (along with other muscles) control movement of humerus 32 relative to scapula 36. Furthermore, Figure 2 The distal tendon 40 of the supraspinatus tendon 38 is shown meeting the humerus 32 at the insertion point.

[0066] exist Figure 2 In this embodiment, tendon 38 includes an injured portion 44 located near the insertion portion 42. The injured portion 44 includes a tear 46 that partially extends through tendon 38. This tear 46 may be referred to as a partial thickness tear. The depicted partial thickness tear 46 is on the bursa side of the tendon; however, the tear may also be on the opposite side or articular side of tendon 38 and / or may include an internal tear of tendon 38 that is not visible on any surface.

[0067] Figure 2 An implant delivery system 10 is also shown, which is used to insert a tendon repair implant 24 into the shoulder 28 and position it above the partial thickness tear 46. Figure 2 In the example shown, the tendon repair implant 24 is placed on the bursa side of the tendon, regardless of whether the tear is on the bursa side, the articular side, or inside the tendon. Furthermore, the tendon repair implant 24 can cover multiple tears.

[0068] from Figure 2 It is understood that delivery of the implant 24 (e.g., a sheet implant) to the patient's target site requires the physician to create an incision in the patient sufficient to reach the implantation site. After creating the entry site, the physician may insert a portion of the implant delivery system 10 through the entry site and position the distal end of the implant delivery system 10 adjacent to the target implantation site. The physician may then manipulate the implant delivery system 10 to place the implant delivery device assembly 20 (including the implant 24) from the delivery cannula 34 adjacent to the target implantation site.

[0069] Figure 3The implant delivery system 10 is shown to include an inner shaft 18 extending within the lumen of a delivery cannula 34 and longitudinally movable relative to that lumen. The inner shaft 18 may include a proximal end (not shown) extending from the proximal end of the delivery cannula 34 and / or be manipulated by a user relative to the delivery cannula 34. (As described above regarding...) Figure 1 As described, the proximal ends of the inner shaft 18 and / or the outer shaft 16 can be coupled to the handle 12 (shown in...). Figure 1 The handle 12 can be used to manipulate the inner shaft 18 relative to the outer shaft 16 and the delivery sleeve 34. For example, the trigger 14 can be actuated to give the inner shaft 18 longitudinal movement relative to the outer shaft 16 and the delivery sleeve 34.

[0070] also, Figure 3 The distal end of the inner shaft 18 is shown to be connectable to the yoke 26. Furthermore, the yoke 26 can be connected to the implant assembly 20, whereby the implant assembly 20 may include an implant retainer (such as a rotating arm 25) connected to the implant 24. Additionally, the rotating arm 25 may include an upper beam 48 and a lower beam 50. It is understood that the rotating arm 25 may be constructed as an integral part comprising the upper beam 48 and the lower beam 50. However, in other cases, the upper beam 48 and the lower beam 50 may be separate parts fastened together. Furthermore, the upper beam 48 may be longitudinally aligned with the lower beam 50.

[0071] Furthermore, in some instances, the implant retainer (e.g., rotating arm 25) may include one or more flexible arms 54. Additionally, in some instances, one or more flexible arms 54 may be coupled to the upper beam 48 and / or the implant 24. As described in more detail below, the implant 24 may be secured between the upper beam 48 and the lower beam 50, wherein one or more flexible arms 54 are positioned along the upper side of the implant 24. In some cases, one or more flexible arms may be made of a shape memory material (e.g., nitinol), such that the flexible arms 54 can be flexed, bent, or deflected for placement within the delivery cannula 34.

[0072] Figure 3 It is also shown that the upper beam 48 (which may include one or more arms 54), the lower beam 50, and the implant 24 can rotate relative to the yoke 26 (e.g., pivot, rotate, etc.). For example, Figure 3 The diagram illustrates that after the rotating arm 25 (including the upper beam 48, lower beam 50, and arm 54) and the implant 24 are placed from the distal end of the delivery cannula 34 (by actuation of the trigger 14 of the handle 12), the rotating arm 25 and the implant 24 can pivot relative to the yoke 26 when the user manipulates the insertion of the implant 24 along the tendon target site. For example, the rotating arm 25 and the implant 24 can rotate about a rotation axis that extends perpendicular to the longitudinal axis of the inner axis 18 and / or the outer axis 16. The rotation of the rotating arm 25 and the implant 24 relative to the yoke 26 will be described in more detail below.

[0073] As mentioned above, Figure 3 A perspective view of a portion of the implant delivery system 10 is shown. Figure 3 An inner shaft 18 extending from the distal end of the delivery sleeve 34 is shown. Furthermore, Figure 3 The proximal region of the yoke 26, attached to the distal end of the inner shaft 18, is shown. Furthermore, Figure 3 A rotating arm 25 that is pivotally connected to a yoke 26 is shown.

[0074] In at least some instances, as described above, the implant 24 may be positioned between the upper beam 48 and the lower beam 50, whereby the upper beam 48 and the lower beam 50 can releasably hold the implant 24 between them. For example, when the implant 24 is positioned between the upper beam 48 and the lower beam 50, the upper beam 48 and the lower beam 50 may passively hold the implant 24, for example, by utilizing contact forces between the upper beam 48 and the lower beam 50 of the implant 24. However, in other instances, the implant 24 may include one or more features (structures) that facilitate holding the implant 24 between the upper beam 48 and the lower beam 50.

[0075] Furthermore, as described above, when the implant 24 is positioned between the upper beam 48 and the lower beam 50, the implant 24 can be positioned such that one or more arms 54 engage the upper beam 48 with the top surface of the implant 24. It is understood that the arms 54 can facilitate the deployment, disengagement, flattening, or manipulation of the implant 24 at the target site.

[0076] Figure 3 A flexible arm 54 in a placement configuration is shown. It will be understood that in the placement configuration, arm 54 may include four flat heads located at the distal end regions of each of the four arms, whereby each of the four arms extends at an angle relative to the upper beam 48. It will also be understood that in some embodiments, arm 54 may be a separate component fixedly attached to the upper beam 48. However, in other embodiments, the flexible arm 54 may be formed as an integral part of the upper beam 48.

[0077] Furthermore, as described above, it is understood that the arms 54 can be designed to conform to the lumen of the delivery cannula 34 when traveling to the target site. Therefore, it is also understood that when positioned within the lumen of the delivery cannula 34, each arm 54 can elastically deform, fold, shift, bend, kink, etc., in a manner that allows insertion of the implant 24 into the lumen of the delivery cannula 34. Thus, the arms 54 can generally be flexible, thereby allowing each arm 54 to bend, twist, fold, wrap, or deform so that the implant 24 conforms to the lumen of the delivery cannula 34 and then returns to an expanded state when no longer constrained by the delivery cannula 34 (as shown in...). Figure 3 ).

[0078] Figure 3Also shown is a rotating arm 25 (which may include an upper beam 48 and a lower beam 50) connected to the yoke 26. In some instances, the yoke 26 may typically include a "U-shaped" component defined by a first longitudinal arm 52 and a second longitudinal arm 53. Figure 3 As shown, the first longitudinal arm 52 may be spaced from the second longitudinal arm 53 to define an opening 56 (e.g., a slot) in which the proximal portion of the rotating arm 25 may be located. It is understood that the opening 56 allows the rotating arm 25 (including the upper beam 48 and the lower beam 50) to rotate relative to the longitudinal axis of the yoke 26. For reference, Figure 6 This illustrates a configuration in which the upper beam 48 and the lower beam 50 are aligned approximately parallel to the longitudinal axis of the yoke 26 and therefore approximately parallel to the longitudinal axis of the inner shaft 18. Furthermore, Figure 7 The diagram illustrates the rotation of the upper beam 48 and the lower beam 50 about an axis of rotation perpendicular to the longitudinal axis of the yoke 26 and the inner shaft 18, thus causing the rotating arm 25 to tilt away from the longitudinal axis of the yoke 26. In some embodiments, the rotating arm 5 may be allowed to rotate to an angle of 45 degrees or more, 60 degrees or more, 80 degrees or more, or 90 degrees or more corresponding to the longitudinal axis of the yoke 26 and the inner shaft 18.

[0079] Figure 3 The implant delivery system 10 is also shown to include a spring member 60 configured to position the rotating arm 25 in a desired equilibrium or non-deflected position, but allowing the rotating arm 25 to pivot or rotate away from the equilibrium position when subjected to an external force. For example, the spring member 60 may connect between the yoke 26 and the rotating arm 25, extending, for example, from the proximal portion of the yoke 26 into the proximal region of the rotating arm 25. As will be described in more detail below, the spring member 60 may be designed to elastically flex from a first configuration in which it is generally parallel to the longitudinal axis of the yoke 26 to a second configuration in which it bends away from the longitudinal axis of the yoke 26. The spring member 60 and its configuration relative to the yoke 26 and the rotating arm 25 will be described in more detail later.

[0080] Figure 4 yes Figure 3 A partial exploded view of the implant delivery system 10 described herein. Specifically, Figure 4 An implant assembly 20 (including a rotating arm 25 and an implant 24) is shown removed from the yoke 26. As described above, Figure 4 This demonstrates that the upper beam 48 can be vertically aligned with the lower beam 50, thereby clamping the implant 24 between the upper beam 48 and the lower beam 50. Furthermore, Figure 4As shown, in some instances, the proximal region of the rotating arm 25 may include one or more protrusions 58 extending away from the sides of the rotating arm 25 (e.g., left and right). The protrusions 58 may be generally cylindrical in shape, but other shapes are also conceivable. For example, the protrusions may be circular, oval, triangular, pointed, etc. In other instances, the protrusions are hemispherical in shape and resemble circular bumps extending away from the sides of the rotating arm 25.

[0081] Figure 4 It is also shown that the proximal region of the rotating arm 25 may further include a longitudinally extending aperture located therein. It is understood that the longitudinally extending aperture 64 may be designed to receive the spring component 60 (in... Figure 4 (As shown in the diagram, it extends from the proximal region of yoke 26). Although in Figure 4 The spring component 60 and the hole 64 are illustrated as typically comprising a rectangular shape, but other configurations are also contemplated. For example, it is conceivable that the spring component 60 may be designed as a flat strip, cylinder, spiral, coil, zigzag, tube, etc. Furthermore, the spring component 60 may include one or more undulations, waves, etc. It is also understood that for any given shape and / or configuration of the spring component 60, the hole 63 may include a mating shape that receives a particular shape of the spring component 60. In other embodiments, the spring component 60 may be fastened to the rotating arm 25 and extend proximally from the rotating arm 25 into a hole formed in the yoke 26.

[0082] Figure 4 It is also shown that the yoke 26 may further include one or more longitudinal channels (grooves) 66, each longitudinal channel being positioned along an inner surface of the yoke 26 (e.g., the inner surface of each longitudinal arm of the first longitudinal arm 52 and the second longitudinal arm 53) and extending proximally from the distal front end face 80 of the yoke 26. Furthermore, Figure 4 It is shown that each channel 66 can be vertically located between the upper and lower surfaces of the yoke 26. For example, in some cases, each channel 66 can be located approximately halfway between the upper and lower surfaces of the yoke 26.

[0083] also, Figure 4 The yoke 26 is shown to include one or more recesses 68 designed to mate with one or more protrusions 58 of the rotating arm 25. Figure 4 As shown, one or more recesses 68 may be positioned along each longitudinal channel 66, which extends along the inner surface of the yoke 26. Furthermore, each dashed line 70 indicates that each protrusion 58 on the rotating arm 25 may be configured to be aligned and inserted into each recess 68 positioned respectively along the inner surface of the yoke 26.

[0084] from Figure 4It is also understood that the rotating arm 25 can be coupled to the yoke 26 by aligning, inserting, and sliding each protrusion 58 into each longitudinal channel 66 extending from the front end face 80 of the yoke 26. For example, each protrusion 58 can be aligned with its respective longitudinal channel 66, thereby allowing the rotating arm 25 to slide in a distal-proximal direction, such that each protrusion 58 can be inserted into its respective recess 68. It is understood that the protrusions 58 can be designed to be pressed into the recesses 68, thus preventing the rotating arm 25 from separating from the yoke 26, but still allowing free pivoting relative to the yoke 26 about an axis of rotation extending through the protrusions 58.

[0085] Understandably, although Figure 4 The diagram shows that the protrusion 58 can be designed to insert into a recess 68 positioned along the yoke 26, but it is also conceivable that in other embodiments, the rotating arm 25 may include one or more recesses designed to receive one or more protrusions extending from the inner surface of the yoke 26. In other words, in some embodiments, the yoke 26 may include one or more protrusions (located in...) Figure 4 The recess 68 shown in the diagram is located at the same position as the rotating arm 25, which may include one or more mating recesses (located in the...). Figure 4 (The location of the protrusion 58 is shown). This alternative arrangement will still provide a press-fit arrangement between the protrusion and the recess, thus preventing the rotating arm 25 from separating from the yoke 26, but it can still pivot freely relative to the yoke 26 about a rotation axis extending through the protrusion.

[0086] In addition, although Figure 4 The implant delivery system 10 is shown to include a longitudinal channel 66 extending from the front end face 80 of the yoke 26, but it is also conceivable that the implant delivery system 10 may include one or more vertical channels extending from the upper or lower surface of the yoke 26. In these examples, the protrusion 58 of the rotating arm 25 can be freely vertically translated within the vertical channel. In other words, as the rotating arm 25 rotates relative to the yoke 26, the "pivot point" of the rotating arm (e.g., the axis of rotation may correspond to and extend through the protrusion 58) can move freely vertically up and down relative to the yoke 26 (towards the lower surface of the upper surface).

[0087] In addition, although Figure 4 The illustration shows the spring member 60 being fixedly attached to the yoke 26 and extending into a hole 64 located in the proximal region of the swivel arm 25. However, it is conceivable that in other embodiments, the spring member 60 may be fixedly attached to the proximal region of the swivel arm 25 and extend into a hole located in the yoke 26. This arrangement would still allow the spring member 60 to shift between a first configuration in which it is generally parallel to the longitudinal axis of the yoke 26 and a second configuration in which it is bent relative to the longitudinal axis of the yoke 26.

[0088] Figure 5 It shows along Figure 3 The sectional view of the implant positioning component 20 intercepted by line 5-5. Figure 5 An implant 24 is shown positioned between the upper beam 48 and the lower beam 50 of the rotating arm 25. Furthermore, Figure 5 The opening 56 located at the yoke 26 is shown (shown in Figures 3-4 The proximal region of the rotating arm 25 inside. Furthermore, Figure 5 A spring component 60 is shown, which is fixedly attached to the proximal end of the yoke 26 and extends into a hole 64 located in the proximal region of the rotating arm 25.

[0089] Figure 6 An implant delivery system 10 is shown, comprising an inner shaft 18, a yoke 26, a rotating arm 25, and an implant 24, all located within the cavity 76 of a delivery cannula 34. As described above, the rotating arm 25 may include an upper beam 48 and a lower beam 50 between which the implant 24 is positioned (it should be noted that, for simplicity, in...). Figures 6-9 (The flexible finger is not shown in the image 54). Figure 6 A protrusion 58 of the rotating arm 25, positioned within the groove 68 of the yoke 26, is also shown. Furthermore, Figure 6 A spring component 60 is shown, which is fixedly attached to the proximal end of the yoke 26 and extends into a hole 64 located in the proximal region of the rotating arm 25 (shown in...). Figure 5 It is understood that when positioned inside the lumen 76 of the delivery cannula 34 (e.g., in a delivery configuration prior to placement from the delivery cannula 34), the rotating arm 25 (including the upper beam 48 and the lower beam 50) can be aligned with the implant 24 in a manner generally parallel to the longitudinal axis 72 of the delivery cannula 34.

[0090] Figure 7 This shows the situation after the outer shaft 16 has been retracted in the distal-proximal direction. Figure 6 The implant delivery system 10 is shown. As described above, the actuation of the trigger 14 of the handle 12 (shown in...) Figure 1 The outer shaft 16 and delivery cannula 34 can be retracted relative to the inner shaft 18, yoke 26, rotating arm 25 (including upper beam 48 and lower beam 50), and implant 24. Therefore, Figure 7 The proximal retraction of the outer shaft 16 is shown to allow placement of the yoke 26, the rotating arm 25 (including the upper beam 48 and the lower beam 50), and the implant 24 from the delivery sleeve 34.

[0091] Figure 7 It is also shown that after being placed from the delivery sleeve 34, the swivel arm 25 can rotate relative to the yoke 26. For example, Figure 7This shows that the rotating arm 25 (including the upper beam 48 and the lower beam 50) can rotate away from the longitudinal axis 72. Figure 7 In the diagram, the rotation of the rotating arm 25 is depicted by the curved arrow 70. As described above, it can be understood that the rotating arm 25 can pivot about the recess 68 of the yoke 26.

[0092] It is also understandable that, in some instances, the spring component 60 deflects the rotating arm 25 to... Figure 6 The position shown (thus aligning the rotating arm 25 with the longitudinal axis 72) is rotated to Figure 7 The position shown (thereby causing the rotating arm 25 to rotate away from the longitudinal axis 72). For example, in some instances, the spring component 60 may be made of a shape memory material (e.g., a nickel-titanium alloy), which allows it to bend or deform after the outer shaft 16 is retracted, thereby causing the rotating arm 25 to rotate relative to the yoke 26, as described above.

[0093] However, in other cases, the spring component 60 can be designed such that it deflects the rotating arm 25 to align with the longitudinal axis 72, but still allows the rotating arm 25 to rotate relative to the yoke 26. See again Figure 2 For example, the implant delivery system 10 may be designed such that the rotating arm 25 can initially be placed from the delivery cannula 34 in a generally flat configuration, whereby when the rotating arm 25 (and the implant 24) is positioned closer to the tendon target site, the rotating arm 25 can then be rotated relative to the yoke 26 due to an applied external force.

[0094] Figure 8 A portion of another exemplary implant delivery system 100 is shown. Figure 8 This portion of the implant delivery system 100 shown may be similar in shape and function to the implant delivery system 10 described above. For example, the implant delivery system 100 may include an inner shaft 118 extending within the lumen 176 of the delivery cannula 134. Furthermore, the distal end of the inner shaft 118 may be coupled to a yoke 126. Additionally, a rotating arm 125 may be pivotally coupled to the yoke 126. The rotating arm 125 may include an upper beam 148 and a lower beam 150. Furthermore, the implant 124 may be positioned between the upper beam 148 and the lower beam 150, wherein the upper beam 148 and the lower beam 150 apply compressive forces to the implant 124 to securely hold the implant 124 between them. The rotating arm 125 may also include one or more protrusions 158 that engage with one or more grooves on the yoke 126, thereby allowing the upper beam 148 and the lower beam 150 to rotate relative to the yoke 126 about a longitudinal axis extending through the protrusions 158 and perpendicular to the inner shaft 118 and the axis of rotation of the yoke 126.

[0095] Figure 8It is also shown that, in some instances, the lower beam 150 may be made of a material similar in shape and function to the material used to manufacture the spring component 60 of the implant delivery system 10 described above. For example, the lower beam 150 may be made of an elastic material (e.g., a flexible metallic material) designed to be in a first position (e.g., where the rotating arm 125 is aligned with the longitudinal axis 172) with Figure 9 The lower beam 150 may flex or deflect between the second positions shown (e.g., where the rotating arm 125 is rotated away from the longitudinal axis 172). In some instances, the lower beam 150 may be made of a shape memory material (e.g., a nickel-titanium alloy).

[0096] In some instances, the lower beam 150 may be made of a shape memory material that causes the rotating arm 25 to deflect from... Figure 8 The axial alignment position shown (thus aligning the rotating arm 125 with the longitudinal axis 172 of the delivery sleeve 134) is rotated to... Figure 9 The tilted position shown (thereby bending the lower beam 150 and rotating the rotating arm 125 away from the longitudinal axis 172 of the delivery sleeve 134, so that the rotating arm 25 is positioned at an angle of inclination or perpendicular to the longitudinal axis 172). In some instances, the lower beam 150 may be made of a shape memory material (e.g., a nickel-titanium alloy), which allows it to bend or deform after the delivery sleeve 134 is retracted, thereby causing the rotating arm 125 to rotate relative to the yoke 126, as described above.

[0097] However, in other cases, the lower beam 150 can be designed such that it biases the rotating arm 125 to align with the longitudinal axis 172, but still allows the rotating arm 125 to rotate relative to the yoke 126 when subjected to an applied external force. See again Figure 2 For example, the implant delivery system 100 may be designed such that the rotating arm 125 can initially be placed within the delivery cannula 134 in a generally flat configuration, whereby the rotating arm 125 (and the implant 124) can rotate relative to the yoke 126 due to the applied external force when the rotating arm 125 (and the implant 124) is located closer to the tendon target.

[0098] Understandably, the lower beam 150 can be attached to the upper beam 148 using various attachment techniques. In some cases, adhesives, screws, pins, tenons, etc., can be used to securely attach the lower beam 150 to the upper beam 148. In other examples, such as Figure 8In the example shown, the lower beam 150 can be inserted through an opening (e.g., a hole) extending inside the upper beam 148. It is understood that the portion of the lower beam 150 extending inside the opening in the upper beam 148 can be fixedly attached to the upper beam 148 (e.g., using adhesive). In other cases, the lower beam 150 can be slidably coupled to the upper beam by passing the lower beam 150 through the opening in the upper beam 148.

[0099] Figure 10 A portion of another implant delivery system 200 is shown (the entire implant delivery system 200 is shown in...). Figure 11 This part includes an implant 224 attached to an exemplary frame 246 (e.g., an implant placement device, an implant retainer). Various components of the implant delivery system 200 may be similar in shape and function to the implant delivery system 10 described above. For example, such as... Figure 11 As shown, the implant delivery system 200 may include an outer shaft 216 coupled to a handle 212. Furthermore, as with the outer shaft 16 and delivery cannula 34 described herein, the distal end of the outer shaft 216 may include a delivery cannula 234. A frame 246 may be positioned within the lumen of the delivery cannula 234 upon travel to the target site. Additionally, it is understood that actuation of the actuating member 218 coupled to the handle 212 may retract the outer shaft 216, thereby placing the frame 246 and the implant 224 from the delivery cannula 234.

[0100] As described above with respect to implant delivery system 10, delivery by implant delivery system 200 may include insertion of outer shaft 216 and delivery cannula 234 through an entry point (e.g., an incision) and advancement to the target site. During advancement to the target site, the removable frame 246 and implant 224 (combination) may be rolled up and / or folded onto themselves such that they are located within the lumen of delivery cannula 234. Furthermore, the combination of removable frame 246 and implant 224 may remain rolled up and / or folded within the lumen of delivery cannula 234 until it is placed from delivery cannula 234.

[0101] For example, after positioning the distal end of the delivery cannula 234 near the target site, the clinician can place a removable frame 246 (along with the implant 224) from the lumen of the delivery cannula 234, for example, by retracting the outer shaft 216 and the delivery cannula 234 and positioning the implant 224 and frame 246 above the target site. As will be described in more detail below, when not constrained by the delivery cannula 234, the frame 246 and implant 224 can automatically expand to an open state. Furthermore, in some instances, the frame 246 can be "shape-set" so that its placement configuration generally matches the curvature of the humeral head. In other words, when not constrained by the delivery cannula 234, the frame 246 can expand to a generally curved configuration that matches the curvature of the humeral head.

[0102] like Figure 10 As shown, the detachable frame 246 may include a body portion 256. In some instances, the body portion 256 may resemble a square, rectangular, circular, oval, or similarly shaped frame from which other components may extend. For example, the body portion 256 of frame 246 may share some similarities with an elongated rectangle having proximal and distal portions. Furthermore, the body portion 256 may include one or more openings defined between struts of the body portion 256. Additionally, Figure 10 The frame 246 may also include connecting legs 264 and a head 258, which can be used to connect the frame 246 to other components of the implant delivery system 200 (e.g., Figure 10 The inner shaft 236 and the tether 282 are shown. It should be noted that the inner shaft 236 is depicted with dashed lines and extends above the collar 276; its details will be described in more detail later. Furthermore, Figure 10 It is also shown that frame 246 may include one or more attachment arms 264a / 264c, which can be used to releasably attach implant 224 to frame 246.

[0103] It is understood that the detachable frame 246 can be a monolithic structure made of a hyperelastic metallic material (such as nitinol). However, it is also conceivable that the detachable frame 246 can be made of alternative materials and / or manufacturing methods. For example, the frame 246 or its parts can be made of polymeric materials, ceramic materials, and / or various other materials. Furthermore, the frame 246 can be manufactured using injection molding or alternative polymeric manufacturing methods. Alternatively, if desired, the frame 246 can be formed by a 3D printing process. Moreover, different parts of the frame 246 (e.g., as described above) can be made of various materials and combined using alternative methods. For example, attachment arms 264a / 264c can be made of polymeric materials and combined with a central frame member made of metallic materials. Variations combining different materials with different parts of the frame 246 are conceivable.

[0104] Figure 10 It is also shown that the implant delivery system 200 described herein may include a tackmember 292, which is designed to secure the delivery system 200 in place before the clinician attaches the implant 224 to the bone and / or tendon. For example, Figure 10 A positioning member 292 extending distally from the positioning disk 280 is shown. (See figure) Figure 10 As shown, the positioning member 292 may extend distally from the positioning disc 280 and is substantially perpendicular to the implant 224 and / or the frame 246.

[0105] In some cases, the positioning member 292 may resemble a cylindrical pin or rod extending away from the frame 246. Furthermore, the positioning member 292 may be designed to have sufficient rigidity to be struck and / or inserted into bone. For example, in some situations, a clinician may apply force to the proximal portion of the implant delivery system 200 (e.g., at the proximal end of the inner shaft 236) such that the positioning member 292 can be "hammered" into a body structure (e.g., bone). Figure 10 As shown, the positioning member 292 may include a tapered distal tip, which may in some cases be a pointed or blunt tapered distal tip. Figure 10 This shows when frame 246 is in Figure 10 In the placement configuration, the positioning member 292 can extend through one of the openings 252 defined in the main body 256. Furthermore, when the positioning member 292 is attached to the frame 246 in the placement configuration (e.g., Figure 10 (As shown) can extend through implant 224.

[0106] Figure 10 The implant delivery system 200 is also shown to include a tether 282 secured to the proximal end of the positioning member 292, for example, coupled to a positioning disc 280, which is correspondingly coupled to or formed as part of the positioning member 292. Thus, the positioning member 292 can be secured to the tether 282 via the positioning disc 280. Therefore, after the positioning member 292 has been inserted into the bone, the tether 282 can be pulled back on the positioning member 292, thereby releasing it from the target site (e.g., bone).

[0107] Furthermore, the frame 246 can also be connected to the tether 282 via a connector (e.g., a combination of the positioning disc 280 and the collar 276). It is understood that both the positioning disc 280 and the collar 276 can be securely attached to the tether 282. Furthermore, as described above, Figure 10 The diagram shows that the positioning disc 280 can be coupled to both the head 258 and the connecting leg 264b of the frame 246. Specifically, the head 258 and the connecting leg 264b can be "clamped" between the distal surface or edge of the collar 276 and the proximal surface or edge of the positioning disc 280. In other words, the head 258 and the connecting leg 264b of the frame 246 can be constrained between the collar 276 and the positioning disc 280. Thus, by being clamped between the collar 276 and the positioning disc 280, the frame 246 can be coupled to the tether 282.

[0108] As described above, the implant delivery system 200 may include an inner shaft 236 that extends within the lumen of the outer shaft 216 and is longitudinally movable relative to the lumen. In some instances, the proximal ends of the inner shaft 236 and / or the outer shaft 216 may be coupled to a handle 212. Furthermore, the distal end of the inner shaft 236 may be designed to engage a collar 276. For example, the lumen of the inner shaft 236 may be designed to mate with the outer contour of the collar 276, thereby allowing the distal end of the inner shaft 236 to extend over the collar 276. Thus, manipulation of the inner shaft 236 may induce movement in the collar 276 (and consequently, the frame 246). It is understood that the handle 212 may be used to manipulate the inner shaft 236 relative to the outer shaft 216 and the delivery cannula 234. For example, the handle 212 may be used to apply a rotational force to the inner shaft 236 and / or the longitudinal movement of the inner shaft 236 relative to the outer shaft 216 and the delivery cannula 234. In some cases, the tether 282 may extend proximally through the cavity of the inner shaft 236 to the handle 220. The frame 246 may be detached from the inner shaft 236, allowing the inner shaft 236, outer shaft 216, and handle 212 to be removed while the frame 246 remains attached to the tether 282.

[0109] As mentioned above, Figure 11 The entire exemplary implant delivery system 200 is shown. The implant delivery system 200 may include a handle 212. Figure 11 The implant delivery system 200 is also shown, including a delivery cannula 234 that can accommodate a combination of a frame 246 and an implant 224 (shown in...). Figure 10 ). Figure 11 It is shown that the handle 212 can be attached to the delivery sleeve 234 via the outer shaft 216.

[0110] As described above, when in the delivery configuration, the delivery cannula 234 can surround the frame 246 and the implant 224. In other words, during delivery to the treatment site, the frame 246 and the implant 224 can be accommodated within the lumen of the delivery cannula 234 in a folded delivery configuration. For example, it can be understood that in the delivery configuration, the implant 224 can be attached to the frame 246, whereby the implant 224 and the frame 246 (together) can be folded and positioned within the delivery cannula 234.

[0111] Furthermore, it is understood that retraction of the outer shaft 216 can release (e.g., place) the implant 224 and frame 246 from the delivery cannula 234. In other words, when the outer shaft 216 is inserted into the patient's body and directed toward the target site, the implant 224 and frame 246 can be positioned inside the delivery cannula 234. After positioning at the target site, the outer shaft 216 and the delivery cannula 234 secured to it can be retracted while the inner shaft 236 remains stationary relative to the outer shaft 216. As described above, retraction of the outer shaft 216 relative to the inner shaft 236 and frame 246 can retract the delivery cannula 234 relative to them, which exposes (e.g., releases) and places the implant 224 and frame 246.

[0112] Figure 11 It is also shown that the handle 212 may include an actuating member 218 (e.g., a trigger) positioned within a first circumferential recess 221 of the channel 220. As will be described in more detail below, actuation of the actuating member 218 (by translating the actuating member 218 within the channel 220) retracts the outer shaft 216 relative to the inner shaft 236 and the handle 212. Furthermore, it is understood that the actuating member 218 may be fixedly fastened to the proximal end of the outer shaft 216 (while the proximal end of the inner shaft 236 may be fixedly fastened to the housing of the handle 212). Thus, displacement of the actuating member 218 from a position where it is closer to the distal end 213 of the handle 212 to a position where it is closer to the proximal end 215 of the handle 212 retracts the outer shaft 216 relative to the inner shaft 236, which also retracts the delivery sleeve 234, thereby placing the frame 246 and the implant 224.

[0113] Figure 11 A tether 282 extending from the proximal end 215 of the handle 212 is also shown. It is understood that the tether 282 should be easily accessible to the user in order to release the positioning member 292 using the tether 282. Figure 11 The diagram shows the tether 282 extending from the positioning member 292 through the inner shaft 236 (located inside the cavity of the outer shaft 216), through the handle 212, and to a position outside the handle 212 (e.g., extending past the handle 212 to a position proximal to the handle 212). As described above, the tether 282 can also be secured to the frame 246 (e.g., using the combination of the collar 276 and the positioning disc 280), or secured to the frame 246 by other methods as described above.

[0114] Figure 11An actuating member 218 is shown located within a recess 221 of channel 220. It is understood that when positioned within the recess 221, the actuating member 218 is prevented from shifting in the distal-proximal direction, thereby preventing unintentional placement of the frame 246 and implant 224. In other words, the frame 246 and implant 224 will not be placed until the user chooses to rotate the actuating member 218 out of the recess 221 and slide the actuating member in the distal-proximal direction within the longitudinal channel (groove) 220. This is an important safety feature during operation of the implant delivery system 200.

[0115] As described above, the tether 282 can be used to release the positioning member 292 after it has been inserted into the bone. It is understood that pulling on the tether 282 requires the tether 282 to move freely relative to the handle 212. However, in some cases, it is preferable to clamp and secure the tether 282 relative to the handle 212 until the user chooses to release it. Therefore, in some instances, the delivery system 200 may include a tether clamping mechanism 228 (e.g., ...). Figure 13 As shown in the diagram, it can clamp and secure the tether member 282 relative to the handle 212. In some cases, after retracting the outer sheath 234, further manipulation of the actuating member 218 exposes the frame 246, and the implant 224 can release or loosen the tether member 282 from the handle 212. For example, further manipulation of the actuating member 218 can cause the actuating member 218 to move the tether clamping mechanism 228 from a locked or engaged position to an unlocked disengaged position to release the tether member 282. In some cases, the actuating member 218 can be retracted proximally in the longitudinal direction (along the longitudinal axis) to retract the outer sheath 234, and then further manipulation of the actuating member 218 in the circumferential direction (e.g., rotation about the longitudinal axis) can cause the actuating member 218 to move the tether clamping mechanism 228 from a locked or engaged position to an unlocked disengaged position to release the tether member 282. Figures 12-18 The image further illustrates a possible configuration.

[0116] As mentioned above, Figure 12 This shows that the actuating member 218 has rotated out of the groove 221 and has been translated in the proximal direction along the longitudinal channel 220 to approximately the midpoint between the first groove 221 and the second groove 223. Furthermore, in Figure 12 As can be understood from the position shown, the outer shaft 216 has been retracted, and thus the implant 224 and frame 246 have been partially placed from the lumen of the delivery cannula 234. Figure 12 The implant 224 and frame 246 are shown in a coiled configuration before being fully expanded.

[0117] Figure 13 It shows Figure 12The exploded view of the handle 212 shown. As described above, the actuating member 218 has been rotated out of the groove 221 and has been translated in the proximal direction along the channel 220 to approximately the middle between the first groove 221 and the second groove 223. Figure 13 An outer shaft 216 extending proximally from the delivery sleeve 234 to the actuating member 218 is also shown. As described above, Figure 13 It is also shown that the tether 282 can be drawn from the (foregoing) member 292, through the inner cavity of the inner shaft 236 (extending through the outer shaft 216), through the orifice 226 located in the actuating member 218, through the tether clamping mechanism 228 and thereafter away from the proximal end of the handle 212.

[0118] As described above, it is understood that the tether clamping mechanism 228, when in the locked position, can securely fasten the tether 282 to prevent relative longitudinal movement with respect to the inner shaft 236, the outer shaft 216 and the handle 212. Figure 13 The tether clamping mechanism 228 is shown to include a rotatable rod 230 located adjacent to the stop member 232. As will be described in more detail below, the tether 282 may extend through the orifice 226 of the actuating member 218 and be juxtaposed along the surface of the stop member 232, for example, supported along a V-shaped notch of the stop member 232, before exiting the proximal end of the handle 212.

[0119] Furthermore, lever 230 can be biased to a first position in which it clamps (e.g., locks, grips, holds, secures) the tether 282 against the surface of the blocking member 232 (e.g., inside the V-shaped notch of the blocking member 232). For example, lever 230 can be coupled to a spring (or a similar mechanism) that biases lever 230 to a first position in which it clamps (e.g., locks, grips, holds, secures) the tether 282 against the surface of the blocking member 232 (e.g., inside the V-shaped notch of the blocking member 232). In other cases, lever 230 can be flexible and deflected, causing lever 230 to be biased to a first position in which it clamps (e.g., locks, grips, holds, secures) the tether 282 against the surface of the blocking member 232 (e.g., inside the V-shaped notch of the blocking member 232). Thus, and as will be described in more detail below, lever 230 can be rotated or moved away from the blocking member 232 to release the tether 282. The rotation of rod 230 can be achieved by actuating member 218, as described below.

[0120] Figures 14-15 The first step of releasing the tether 282 is shown by rotating the rod 230 relative to the blocking member 232 using the actuating member 218. Specifically, Figure 14The actuating member 218 is shown to have been proximally translated along the channel 220 to a position where it aligns with the second circumferential groove 223. It is understood that the proximal translation of the actuating member 218 along the longitudinal axis retracts the outer shaft 216, allowing the implant 224 and frame 246 to be fully placed from the delivery cannula 234 (e.g., Figure 14 (As shown in the image). Furthermore, Figure 14 A portion of the inner shaft 236 is shown positioned on the distal side of the delivery cannula 234, thereby connecting the inner shaft 236 to the fully expanded frame 246 and the implant 224. Figure 14 Also shown is a tether 282 extending through the inner shaft 236. As described above, the tether 282 can be connected to the positioning member 292.

[0121] Figure 15 It shows Figure 14 An exploded view of the handle 212 shown. As described above, Figure 15 This shows that the actuating member 218 has been translated proximally along the channel 220 to a position where it aligns with the second groove 223. Furthermore, Figure 15 The actuating member 218 is shown to include engagement features, such as a protrusion 225 (e.g., an arm, a rib) extending proximally away from the proximal end of the actuating member 218. Figure 15 As shown, the engagement feature or protrusion 225 may be aligned with the rod 230 before rotating into the second groove 232 about the longitudinal axis. In other words, the engagement feature or protrusion 225 may extend above the upper surface of the blocking member 232 and between the inner surfaces of the rod 230 and the handle 212 before rotating into the second groove 232.

[0122] For example, Figure 16 It shows Figure 15 End views of the actuating member 218, rod 230, and blocking member 232 shown. As described above, Figure 16 The tether 282 is shown inside the V-shaped notch 235 of the blocking member 232. Furthermore, Figure 16 The lever 230 is shown to include a first end 233 biased to clamp the tether 282 within or against the surface of the stop member 232. Additionally, the lever 230 may also include a second end 241 located adjacent to the protrusion 225 of the actuating member 218. (See above regarding...) Figure 15 As described, before rotating into the second groove 232, the protrusion 225 may extend above the upper surface 243 of the blocking member 232 and between the second end 241 of the rod 230 and the inner surface of the handle 212.

[0123] Figures 17-18The following step is illustrated: actuating member 218 is driven to rotate rod 230 relative to blocking member 232, thereby releasing tether 282. Specifically, Figure 17 An actuating member 218 is shown rotating about the longitudinal axis into the second recess 223. It is understood that while the actuating member 218 is rotating into the second recess 223, the outer shaft 216 remains in the retracted position, allowing the implant 224 and frame 246 to be fully placed from the delivery cannula 234. Figure 17 A tether 282 extending through the inner shaft 236 is also shown. When the actuating member 218 is rotated, an engagement feature (e.g., a protrusion 225) engages with the rod 230, causing the rod 230 to move from an engaged or locked position to a disengaged or unlocked position. Therefore, in Figure 17 In the configuration shown, after the actuating member 218 is rotated into the second groove 223 and the rod 230 is moved to the unlocked position, the tether 282 moves freely relative to the inner shaft 236, the outer shaft 216 and the handle 212.

[0124] Figure 18 It shows Figure 17 An end view showing the positions of the actuating member 218, rod 230, and blocking member 232. Specifically, Figure 18 An end view of the actuating member 218, which rotates relative to the blocking member 232, is shown. The rotation of the actuating member 218 is depicted by arrow 237. Figure 18 Understandably, rotation of the actuating member 218 causes the protrusion 225 to engage with the second end 241 of the rod 230. Furthermore, the engagement of the protrusion 225 with the second end 241 of the rod 230 causes the rod 230 to pivot about the pivot point 239, thereby causing the first end 233 of the rod 230 to rotate away from the tether 282. In this configuration, the tether 282 is freely movable relative to the inner shaft 236, the outer shaft 216, and the handle 212.

[0125] Figure 19 Another implant delivery system 300 is shown. It will be understood that the implant delivery system 300 may be similar in shape and function to other implant delivery systems described herein. It will also be understood that... Figure 19 The configuration of the conveying system 300 shown can be similar to... Figure 15 The conveyor system 200 shown.

[0126] For example, the implant delivery system 300 may include an outer shaft 316 coupled to the handle 312. Furthermore, the distal end of the outer shaft 316 may include a delivery cannula 334. As with other delivery systems described herein, the frame 346 and the implant 324 may be positioned within the lumen of the delivery cannula 334 as the system travels to the target site. Additionally, as... Figure 19As shown, it can be understood that the actuation of the handle 312 retracts the outer shaft 316 to place the frame 346 and the implant 324 from the delivery cannula 334. Furthermore, Figure 19 Also shown is a tether 382 extending from the positioning member 392 through the cavity of the inner shaft 336 (which extends through the cavity of the outer shaft 316), through an orifice located in the actuating member 318, through the tether clamping mechanism 340, and exiting the proximal end of the handle 312. Similar to the embodiments described above, after retracting the outer sheath 334 to expose the frame 346 and the implant 324, further manipulation of the member 318 can release or disengage the tether member 382 from the handle 312. For example, further manipulation of the actuating member 318 can cause it to move the tether clamping mechanism 328 from a locked or engaged position to an unlocked disengaged position to release the tether member 382. In some cases, the actuating member 318 may retract proximally in the longitudinal direction (along the longitudinal axis) to retract the outer sheath 334, after which further manipulation of the actuating member 318 in the circumferential direction (e.g., rotation about the longitudinal axis) will cause the actuating member 318 to move the tether clamping mechanism 328 from a locked or engaged position to an unlocked disengaged position to release the tether member 382.

[0127] Figure 19 An actuating member 318 is shown positioned adjacent to the tether clamping mechanism 340. Furthermore, Figure 19 The actuating member 318 is shown to include an engaging member, such as a protrusion 325 located adjacent to the tether clamping mechanism 340 and configured to engage with the surface of the tether clamping mechanism 340. As with the implant delivery system 200 described above, it is understood that rotation of the actuating member 318 can engage the protrusion 325 with the tether clamping mechanism 340 to move the tether clamping mechanism from an engaged or locked position to a disengaged or unlocked position, thereby releasing the tether 382.

[0128] For example, Figure 20 An end view of the actuating member 318 relative to the tether clamping mechanism 340 is shown. Figure 20 Also shown is a tether 382 located between a movable (e.g., sliding) component or block 342 (e.g., block, wedge, etc.) of the tether clamping mechanism 340 and a fixed component 348 (e.g., block, wedge, etc.). In some cases, the fixed component 348 may be an extension of the handle 312 (e.g., the fixed component may be an integral part of the handle 312 and extend away from its inner surface). It is understood that the sliding component 342 may be freely movable relative to the fixed component 348. For example, the movable or sliding component 342 may be freely displaced to a position closer to or further away from the fixed component 348.

[0129] also, Figure 20The tether locking mechanism 340 shown may include a configuration member or a spring 344. For example, the spring 344 may include a first end coupled to a movable or sliding member 342 and a second end coupled to an inner surface of a handle 312. Therefore, it can be understood that the spring 344 can apply a force that moves or slides the member 342, thereby biasing the sliding member 342 toward the fixed member 348, thereby compressing the tether member 382 between them. It can also be understood that the force applied to the movable or sliding member 342 by the spring 344 can clamp (e.g., secure, lock, retain) the tether 382 between the movable or sliding member 342 and the fixed member 348. Furthermore, Figure 20 The protrusion 325 of the actuating member 318 is shown to be aligned with the moving or sliding member 342. As described above with respect to the implant delivery system 200, the tether 382 can be clamped or compressed between the moving or sliding member 342 and the fixed member 348 before the actuating member 318 is rotated, and cannot move freely relative to the inner shaft 336, the outer shaft 316, or the handle 312.

[0130] Figure 21 An actuating member 318 that rotates relative to the moving or sliding member 342 and the fixed member 348 is shown. The rotation of the actuating member 318 is depicted by arrow 350. It is understood that the actuating member 318 can be rotated about the longitudinal axis into the second recess of the handle 312. It is also understood that when the actuating member 318 rotates, the engaging feature or protrusion 325 of the actuating member 318 can engage with the sliding member 342. Furthermore, rotation of the protrusion 325 can cause the protrusion 325 to engage with the moving or sliding member 342 and move the moving or sliding member 342 away from the fixed member 348, thereby releasing the tether 382. Therefore, in Figure 21 In the configuration shown, after the actuating member 318 is rotated to the disengaged or unlocked position, the tether 382 moves freely relative to the inner shaft 336, the outer shaft 316, and the handle 312. However, it is also understood that the outer shaft 316 remains in the retracted state, such that the implant 324 and the frame 346 are fully placed from the delivery sleeve 334 when the actuating member 318 is rotated into the recess 323.

[0131] Figure 22 Another implant delivery system 400 is shown. It will be understood that the components of the implant delivery system 400 may be similar in shape and function to other implant delivery systems described herein.

[0132] For example, the implant delivery system 400 may include an outer shaft 416 coupled to an actuating member 458, thereby coupling the actuating member 458 to a handle 412. Furthermore, the distal end of the outer shaft 416 may include a delivery cannula 434. As with other delivery systems described herein, the frame 446 and the implant 424 may be located within the lumen of the delivery cannula 434 while being tracked to the target site. Furthermore, as... Figure 22 As shown, the proximal translation 459 of the actuating member 458 retracts the outer shaft 416 to place the frame 446 and the implant 424 from the delivery cannula 434. This is as described above with respect to the implant delivery system 200. Figure 13 , Figure 22 This shows that the actuating member 458 has been translated in the proximal direction along the handle 412 to approximately the midpoint between the first groove 421 and the second groove 423 of the handle 412. Furthermore, it can be understood that... Figure 22 In the position shown, the outer shaft 416 has been retracted, so that the implant 424 and the frame 446 have been partially placed from the lumen of the delivery cannula 434.

[0133] Figure 22 The implant delivery system 400 is also shown to potentially include a tether clamping mechanism 460 located proximal to the actuating member 458. The tether clamping mechanism 460 may include engagement features (such as protrusions 461) designed to engage (e.g., for insertion) with mating engagement features (such as orifices 462) located on the actuating member 458. Although Figure 22 The tether clamping mechanism 460 shown may include a protrusion 461 designed to engage with an orifice 462 of an actuating member 458, but it is also conceivable that in other instances, for example, the actuating member 458 may include a protrusion designed to engage with an orifice located on the tether clamping mechanism 460. Figure 22 It is also shown that the tether member 482 can extend through a portion of the tether clamping mechanism 460, for example, between adjacent sidewalls of the tether clamping mechanism 460.

[0134] Understandably, when in the locked position, the tether clamping mechanism 460 can be used to securely fasten the tether 482 to prevent relative longitudinal movement with respect to the inner shaft 436, the outer shaft 416, and the handle 412. As will be described in more detail below, the tether 482 may extend through the orifice of the tether clamping mechanism 460 before exiting the proximal end of the handle 412. Furthermore, the tether clamping mechanism 460 may be displaced in a first position where it compresses or clamps (e.g., locks, grips, holds) the tether 482 within the orifice of the tether clamping mechanism 460. Therefore, and as will be described in more detail below, a portion of the tether clamping mechanism 460 may be moved (e.g., rotated) to release the tether 482. Rotation of the tether clamping mechanism 460 may be accomplished using an actuating member 458, as described below.

[0135] Figure 23 It shows Figure 14 The implant delivery device 400 shown here, wherein the actuating member 458 has been translated proximally to a position in which it aligns with the second circumferential groove 423. Therefore, from Figure 23 Understandably, the outer shaft 416 has been retracted, allowing the implant 424 and frame 446 to be fully placed from the delivery cannula 434. Figure 23 Also shown is a tether 482 that extends from the positioning member 492 through the cavity of the shaft 436 (extending through the outer shaft 416), through an orifice in the actuating member 458, through the tether clamping mechanism 460, and then away from the proximal end of the handle 412.

[0136] also, Figure 23 It is also shown that the actuating member 458 has engaged with the tether clamping mechanism 460 in the retracted position, as described above. It is understood that in Figure 23 In the configuration shown, the engagement feature of the tether clamping mechanism 460 (e.g., protrusion 461) has engaged with the mating engagement feature of the actuating member 458 (e.g., it has been inserted into the orifice 462 of the actuating member 458). Figure 23 In the configuration shown, the tether member 482 can be compressed or clamped (e.g., locked, secured, retained) inside the orifice of the tether clamping mechanism 460. As described above, a portion of the tether clamping mechanism 460 can be rotated to release the tether 482. For example, a first sidewall of the tether clamping mechanism 460 can be pivoted or offset relative to an adjacent second sidewall of the tether clamping mechanism 460, thereby widening a portion of the orifice as the tether 482 extends. Rotation of the tether clamping mechanism 460 can be accomplished using an actuating member 458, as described below.

[0137] For example, Figure 24 The actuating member 458 is shown relative to Figure 23 End view of the position of the rope clamping mechanism 460 shown. Figure 24 The tether clamping mechanism 460 is also shown to include a first sidewall 470 spaced from the second sidewall 468, whereby the tether 482 can be positioned between the first sidewall 470 and the second sidewall 468. Furthermore, Figure 24 The bottom of the tether clamping mechanism 460 is shown to connect the first sidewall 470 to the second side 468 and can also be secured to the frame 465. The frame 465 extends from the inner surface of the handle 412.

[0138] It is understood that when positioned between the first sidewall 470 and the second sidewall 468, the tether 482 can be in a locked position, thereby preventing the tether 482 from moving relative to the inner shaft 436, the outer shaft 416, or the handle 412. Furthermore, it is understood that rotation of the first sidewall 470 away from the second sidewall 468 can release the tether 482 and allow it to move relative to the inner shaft 436, the outer shaft 416, or the handle 412.

[0139] also, Figure 24 The tether clamping mechanism 460 is shown to include an angled protrusion 466 designed to engage with a first end 467 of a second sidewall 468. This engagement of the protrusion 466 with the first end 467 of the second sidewall 468 provides an interference fit between the protrusion 466 and the first end 467 of the second sidewall 468, which needs to be overcome to allow the first sidewall 470 to rotate away from the second sidewall 468. Furthermore, Figure 24 An aperture 462 of the actuating member 458 is shown, which can be designed to receive a protrusion 461 of the tether clamping mechanism 460, as described above.

[0140] Figure 25 An actuating member 458 that rotates relative to the handle 412 is shown. Figure 25 In the diagram, rotation of the actuating member 458 is depicted by arrow 471. It is understood that after retracting the actuating member 458 proximally to place the implant 424, the actuating member 458 can be rotated into the second recess 423 of the handle 412. It is also understood that when the actuating member 458 is rotated, a portion of the tether clamping mechanism 460 can also rotate with the actuating member 458 (because the tether clamping mechanism 460 engages with the actuating member 458 via a protrusion 461 of the tether clamping mechanism 460 extending into the orifice 462 of the actuating member 458). For example... Figure 25 The diagram shows that when the actuating member 458 rotates into the second recess 423 of the handle 412, the first sidewall 470 rotates away from the second sidewall 468. However, as described above, in order to rotate the tether clamping mechanism 460 (together with the actuating member 458), the interference force formed between the inclined protrusion 466 and the first end 467 of the second sidewall 468 needs to be overcome. However, if this interference force is overcome and the tether clamping mechanism 460 is rotated, the tether 482 can move freely relative to the inner shaft 436, the outer shaft 416, and the handle 412. It is also understood that the outer shaft 416 remains in the retracted state, so that when the actuating member 458 and the tether clamping mechanism 460 are rotated, the implant 424 and the frame 446 are fully placed from the delivery cannula 434.

[0141] It should be understood that this disclosure is illustrative in many respects. Changes may be made in the details, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of this disclosure. This may include, to appropriate extent, applying any feature of one exemplary embodiment to other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. An implant delivery system, the implant delivery system comprising: An outer shaft having a proximal end, a distal end, and an inner cavity extending therein; An inner shaft including a proximal end and a distal end, the inner shaft extending within at least a portion of the cavity of the outer shaft; A yoke, which is fixed to the distal end of the inner shaft; as well as An implant retainer is attached to the yoke, wherein the implant retainer is configured to capture the implant, the implant retainer has an upper beam fixed to the lower beam, the implant retainer is configured to capture the implant between the upper beam and the lower beam, and wherein the implant retainer is configured to rotate about a rotation axis perpendicular to a longitudinal axis perpendicular to the yoke and the inner axis.

2. The implant delivery system of claim 1 further includes a spring component connected to both the yoke and the implant retainer.

3. The implant delivery system of claim 2, wherein the spring component includes a first end and a second end, wherein the first end is fixedly attached to the yoke, and wherein the second end extends away from the yoke and is positioned inside an inner hole in the implant retainer.

4. The implant delivery system of claim 2, wherein the spring component includes a first end and a second end, wherein the first end is fixedly attached to the implant retainer, and wherein the second end extends away from the implant retainer and is positioned inside an inner hole on the yoke.

5. The implant delivery system of any one of claims 2 to 4, wherein the spring member is configured to buckle between a first position in which it is aligned with the longitudinal axis of the yoke and a second position in which it is offset from the longitudinal axis of the yoke.

6. The implant delivery system of claim 5, wherein the spring member is configured to bias the implant retainer to the second position after the implant is placed from the cavity of the outer shaft.

7. The implant delivery system of claim 6, wherein the lower beam includes a spring member coupled to the upper beam, and wherein the spring member includes a proximal end extending into a hole in the yoke.

8. The implant delivery system of any one of claims 1 to 4, wherein the yoke includes a first longitudinal arm spaced apart from the second longitudinal arm, and wherein the first longitudinal arm includes a first recess configured to receive a first protrusion positioned on the implant retainer, and wherein the second longitudinal arm includes a second recess configured to receive a second protrusion positioned on the implant retainer.

9. The implant delivery system of claim 8, wherein the first protrusion is configured to pivot within the first recess, and wherein the second protrusion is configured to pivot within the second recess.

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