Tissue Anchor Access System and Method

Abstract

The present application provides a device for use with an anchor access device (20). The device includes a holder (90) shaped to define a space (92) for receiving the anchor access device (20). The holder (90) includes a coupler (94) configured to reversibly couple the anchor access device (20) to the holder (94). The device further includes a wearable article (100) coupled to the holder (90). The wearable article (100) is configured to temporarily attach the anchor access device (20) to the body of a surgeon using the anchor access device (20). Other applications are also described.

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application 62 / 853,850, filed May 29, 2019, by Brauon et al., titled "Tissue anchor handling systems and methods," which has been assigned to the assignee of the present invention and is incorporated herein by reference in its entirety for all purposes. Background of the Invention

[0003] Various medical procedures may require tissue anchors. And these tissue anchors need to be easily accessible to facilitate access to the tissue anchors during medical procedures. There is a need for improved - designed tissue - anchor holders and magazines as well as devices to make tissue anchors more accessible and usable. Summary of the Invention

[0004] The present summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, the claims do not require any features included in the examples of the present summary unless the claims expressly recite those features. Additionally, the features, components, steps, concepts, etc. described in the examples in the present summary and elsewhere in this disclosure can be combined in various ways. The description herein relates to systems, components, methods, devices, apparatuses, combinations, etc. that can be utilized to anchor something to tissue. The various features and steps described elsewhere in this disclosure can be included in the examples summarized herein. The methods, operations, steps, etc. described herein can be performed on live animals or non - live cadavers, cadaver hearts, simulators (e.g., having simulated body parts, tissues, etc.), etc.

[0005] An anchor - handling device is configured to facilitate access to one or more tissue anchors. The tissue anchors herein can assume a variety of different configurations, shapes, and / or sizes. The anchor - handling device holds the anchor in an anchor - storage partition of a channel and / or storage area or space defined by a housing until a tool (e.g., an anchor driver) is used to retrieve the anchor. The tool is advanced through the channel and / or storage area, coupled to the anchor, and withdrawn proximally from the channel and / or storage area together with the anchor. The anchor - handling device can and in some embodiments is configured to release (e.g., dispense, etc.) the anchor only when the force (e.g., a proximally - directed force) applied to the anchor by the tool is greater than a predefined threshold force (i.e., sufficient) to prevent the anchor from accidentally exiting.

[0006] In some embodiments, the retaining member is configured to retain the tissue anchor in the anchor storage partition.Sufficient force or sufficient proximally directed force moves the retaining member away from the anchor, such as by moving the anchor to move the retaining member.

[0007] The wearable article can be, and in some embodiments is, coupled to a holder that is shaped to define a space for receiving an anchor access device. The holder is shaped to define a housing (e.g., a cradle) and a coupling configured to reversibly couple the anchor access device to the holder. In some embodiments, the wearable article is configured to temporarily attach the anchor access device to the body of a surgeon using the anchor access device. For some applications, the wearable article includes a strap, such as a wristband or a strap configured to be worn around the central portion of the surgeon's hand or around the surgeon's arm. For some applications, the wearable article includes an adhesive to temporarily attach the anchor access device to the surgeon's clothing or gloves.

[0008] The anchor driver for driving the tissue anchor into the tissue of the subject has a first flexible state and a second flexible state that is less flexible than the first flexible state. For some applications, the anchor driver comprises a tube, which is reinforced and made rigid and less flexible by a rigid or semi-rigid shaft that is advanced in the tube of the anchor driver. For some applications, a mechanism is provided at the distal end portion of the anchor driver, which enables the elongated element of the driver to pivot relative to the anchor engagement head of the driver that engages the tissue anchor.

[0009] Therefore, according to some applications, a system and / or apparatus for use with an anchor access device is provided. The system and / or apparatus includes a holder shaped to define a space for receiving the anchor access device, the holder including a coupling configured to reversibly couple the anchor access device to the holder; and a wearable article coupled to and / or integrated with the holder, the wearable article being configured to temporarily attach the anchor access device to the body of a user (e.g., a surgeon, etc.) using the anchor access device.

[0010] In use, the system and / or apparatus includes an anchor access device, and the anchor access device includes a housing shaped to define a channel having an anchor storage partition and a proximal opening.

[0011] In use, the wearable article includes an adhesive configured to temporarily attach the anchor access device to a surgeon's clothing.

[0012] In use, the wearable article includes an adhesive configured to temporarily attach the anchor access device to a surgeon's glove.

[0013] In an application, the wearable item includes a hook-and-loop fastener configured to temporarily attach the anchor access device to a surgeon's clothing.

[0014] In an application, the wearable item includes a hook-and-loop fastener configured to temporarily attach the anchor access device to a surgeon's glove.

[0015] In an application, the wearable item includes a rigid material at at least a portion thereof near the gripper.

[0016] In an application, the wearable item includes a thin metal sheet. In an application, the thin metal sheet is malleable.

[0017] In an application, the system and / or device includes a hingeable coupler configured to couple the gripper to the wearable item in a manner that the gripper is hingeable relative to the wearable item.

[0018] In an application, the hingeable coupler includes a swivel coupler. In an application, the strap includes a shape memory material.

[0019] In an application, the wearable item includes a strap. In an application, at least a portion of the strap includes a stretchable and flexible material. In an application, the strap includes a wristband.

[0020] In an application, the strap includes a first portion and a second portion, the first portion including a stretchable and flexible material, and the second portion including a material that is less stretchable and less flexible compared to the stretchable and flexible material of the first portion.

[0021] In an application, the second portion is near the gripper.

[0022] In an application, the strap is shaped to define a first end and a second end.

[0023] In an application, the strap includes a buckle that reversibly fastens the first end and the second end of the strap. In an application, the strap includes a magnet that reversibly fastens the first end and the second end of the strap.

[0024] In an application, the strap includes at least one spring configured to expand and contract a portion of the strap.

[0025] In an application, at least a portion of the strap is rigid.

[0026] In an application, at least that portion is near the gripper.

[0027] In an application, the strap is shaped to define a closed loop.

[0028] In an application, at least a portion of the strap comprises a stretchable and flexible material.

[0029] In an application, the strap comprises a first portion and a second portion, the first portion comprising a stretchable and flexible material and the second portion comprising a non-stretchable and less flexible material compared to the stretchable and flexible material of the first portion.

[0030] In an application, the second portion is near the gripper.

[0031] In an application, the strap comprises at least one spring configured to expand and contract a portion of the strap.

[0032] In an application, at least a portion of the strap is rigid.

[0033] In an application, the coupler comprises a male coupler configured to project into a space defined by the gripper.

[0034] In an application, the coupler comprises a detent.

[0035] According to some applications, the system and / or device (e.g., the above-described system and / or device or another device or system herein) comprises an anchor access device (e.g., the above-described anchor access device or another anchor access device herein).

[0036] The anchor access device comprises a housing shaped to define a channel and / or storage area / storage space having an anchor storage compartment and a proximal opening.

[0037] In an application, the anchor access device is shaped to define a female coupler configured to receive the male coupler of the gripper to facilitate reversibly locking the anchor access device to the gripper.

[0038] In an application, the anchor access device comprises a detent movable in response to a force applied to the detent by the male coupler of the gripper to facilitate reversibly locking the anchor access device to the gripper.

[0039] In an application, the anchor access device comprises a depressible element coupled to the detent, and the depressible element is pushable by a surgeon to apply a force to the detent.

[0040] In an application, the device further comprises a tissue anchor stored in the anchor storage compartment.

[0041] In an application, the tissue anchor is configured such that when stored in the anchor storage partition, the tissue anchor is movable proximally out of the anchor storage partition in response to a proximally directed force applied to the tissue anchor, the proximally directed force being greater than a predetermined threshold force.

[0042] In an application, the tissue anchor is sized to fit snugly within the anchor storage partition.

[0043] In some applications, the system and / or device further includes a retention member. The retention member has a longitudinal axis and has a retention state in which the retention member is configured to retain the tissue anchor within the anchor storage partition. In some applications, the retention member is further configured to allow the tissue anchor to move out of the anchor storage partition in response to a force (e.g., a proximally directed force, etc.) applied to the tissue anchor by moving in response to the force (e.g., a proximally directed force, etc.), the force being greater than a predetermined threshold force.

[0044] In an application, the device further includes a pivot coupled to the retention member, the pivot including a support post that can be coupled to the tissue anchor, and the pivot pivots the support post and the tissue anchor away from the longitudinal axis of the retention member.

[0045] In an application, the anchor is shaped to define a lumen, and the support post is shaped to define a rod that fits within the lumen of the tissue anchor.

[0046] In an application, the retention member is shaped to define a bracket at its proximal end, the bracket defining a first inclined surface and a second inclined surface, the first and second surfaces being configured to abut the tissue anchor such that the anchor fits snugly within the anchor storage partition.

[0047] In an application, the first inclined surface and the second inclined surface are adjacent to form a vertex of the bracket. In an application, the first inclined surface and the second inclined surface form a generally "V" shape.

[0048] In some applications: The housing is configured to define a plurality of channels, each of the plurality of channels having a corresponding anchor storage partition / region and a corresponding proximal opening. The system / device may include a plurality of tissue anchors that are slidable through the corresponding channels and are configured to be stored in the corresponding anchor storage partitions / regions.

[0049] In some applications, the system and / or device includes a plurality of retention members (e.g., within the housing), each retention member being configured to retain a corresponding tissue anchor within a corresponding anchor storage partition and to allow the corresponding tissue anchor to move out of the corresponding anchor storage partition in response to a force (e.g., a proximally directed force) applied to the corresponding tissue anchor.

[0050] In use, the device further includes an anchor driver, and in the retention state, the anchor driver is slidable through at least a portion of the channel and is reversibly lockable to the tissue anchor.

[0051] In some applications, the housing is shaped to define a chamber in fluid communication with the channel, the chamber having a longitudinal axis, and at least a portion of the retention member is configured to slide within the chamber in response to a force applied to the tissue anchor or a proximally directed force applied to the tissue anchor.

[0052] In use, the retention member includes a pin configured to slide through the chamber.

[0053] In some applications, the housing is shaped to define a first cavity and a second cavity in fluid communication with the chamber. At least a portion of the retention member may be resilient. The pin is shaped to define a first leg and a second leg compressible toward each other and toward the longitudinal axis of the chamber, each of the first leg and the second leg being shaped to define a respective ratchet.

[0054] In use, the system / device is sized such that when the retention member allows the tissue anchor to leave the anchor storage compartment, further proximal movement of the retention member causes the respective ratchets of the first leg and the second leg to move into the respective first cavity and second cavity.

[0055] In use, the first cavity and the second cavity and the respective ratchets of the first leg and the second leg are sized such that when each ratchet is disposed within the respective first cavity and second cavity, the distally directed force required to return the device to the retention state is more than twice the threshold force.

[0056] In some applications, the housing is shaped to define a first cavity and a second cavity in fluid communication with the chamber. At least a portion of the retention member may be resilient. In use, the pin is shaped to define a first leg and a second leg compressible toward each other and toward the longitudinal axis of the chamber, each of the first leg and the second leg being shaped to define a respective ratchet. In the retention state, the resiliency of at least a portion of the retention member may be configured to clamp the ratchets of the first leg and the second leg within the respective first cavity and second cavity. In use, the retention member is configured to deform in response to a force applied to the tissue anchor or a proximally directed force applied to the tissue anchor such that the first leg and the second leg compress toward each other and the respective ratchets of the first leg and the second leg withdraw from the respective first cavity and second cavity.

[0057] In some applications, the outer housing is shaped to define a third cavity and a fourth cavity that are in fluid communication with the chamber. The device can be sized such that when the retention member allows the tissue anchor to leave the anchor storage compartment, further proximal movement of the retention member causes the respective pawls of the first leg and the second leg to move into the respective third cavity and fourth cavity.

[0058] In some applications, the third cavity and the fourth cavity and the respective pawls of the first leg and the second leg are sized such that when each pawl is disposed within the respective third cavity and fourth cavity, the distally-directed force required to return the device to the retention state is more than twice the threshold force.

[0059] In some applications, the anchor driver includes an anchor engagement head at its distal end that can be introduced through an opening in the outer housing and actuated to be reversibly coupled to the tissue anchor. The anchor driver includes a handle at its proximal end, and the handle includes a regulator configured to actuate the anchor engagement head. In an application, the anchor driver can further include an elongate, pushable element disposed between the distal end of the anchor driver and the proximal end of the anchor driver and configured to be advanced through a subject's vasculature via a catheter. In an application, the elongate, pushable element is flexible.

[0060] In an application, the anchor engagement head has a longitudinal axis, and the head is shaped to define a tissue anchor engagement slot configured to engage the proximal end of the tissue anchor, and the slot is angled relative to the longitudinal axis at a non-zero angle.

[0061] In an application, the anchor engagement head is pivotable relative to the elongate, pushable element.

[0062] In an application, the device further includes a coupling pin coupled to the distal end of the elongate, pushable element, and the anchor engagement head is shaped to define at least one slot opening, and the coupling pin is movable within the slot opening to facilitate articulation between the anchor engagement head and the elongate, pushable element.

[0063] In an application, the slot opening is shaped to define a terminal section and a major section that is wider than the terminal section, and when the coupling pin is disposed within the terminal section, movement of the anchor engagement head relative to the elongate, pushable element is restricted, and when the coupling pin is disposed within the major section, movement of the anchor engagement head relative to the elongate, pushable element is facilitated.

[0064] In an application, the elongate, pushable element includes a flexible tube shaped to define a lumen, and the device further includes a shaft slidable relative to the flexible tube to control the flexibility of the flexible tube.

[0065] In an application, the shaft is stiffer than the flexible tube.

[0066] In an application, the elongate pushable element has a first flexible state and a second flexible state that is less flexible than the first flexible state, and the elongate pushable element assumes the second flexible state when the shaft is positioned within the lumen of the flexible tube.

[0067] According to some applications, there is also provided a method including temporarily attaching a wearable article to a surgeon's body, the wearable article being coupled to a holder that is shaped to define a space for receiving an anchor access device, the holder including a coupler configured to reversibly couple the anchor access device to the holder; and reversibly coupling the anchor access device to the holder.

[0068] In an application, the wearable article includes an adhesive, and the temporary attachment includes temporarily attaching the anchor access device to the surgeon's clothing.

[0069] In an application, the wearable article includes an adhesive, and the temporary attachment includes temporarily attaching the anchor access device to the surgeon's glove.

[0070] In an application, the wearable article includes hook-and-loop fasteners, and the temporary attachment includes temporarily attaching the anchor access device to the surgeon's clothing.

[0071] In an application, the wearable article includes hook-and-loop fasteners, and the temporary attachment includes temporarily attaching the anchor access device to the surgeon's glove.

[0072] In an application, the wearable article includes a thin metal sheet, and the temporary attachment includes shaping the thin metal sheet to conform to a part of the surgeon's body.

[0073] In an application, the method further includes articulating the holder relative to the wearable article.

[0074] In an application, the method further includes rotating the holder relative to the wearable article.

[0075] In an application, the wearable article includes a strap, and the temporary attachment includes positioning at least a portion of the strap around a part of the surgeon's body.

[0076] In an application, the positioning includes positioning at least a portion of the strap around a central portion of the surgeon's hand. In an application, the positioning includes positioning at least a portion of the strap around the surgeon's wrist.

[0077] In an application, positioning at least the portion includes sliding the strap around a central portion of the surgeon's hand.

[0078] This method, including its various steps, can be performed as part of training or simulation.

[0079] According to some applications, a system and / or device for use with a tissue anchor is also provided. The system / device includes an anchor driver. In some applications, the anchor driver includes an anchor coupling element (e.g., an anchor engagement head, etc.) configured to reversibly couple the tissue anchor to the anchor driver.

[0080] In some applications, an elongate, propellable element is coupled to the anchor coupling element at its distal end, and the elongate, propellable element has a distal portion. In some applications, the anchor driver also has a distal portion, and the distal portion of the anchor driver has a first flexible state and a second flexible state that is less flexible than the first flexible state.

[0081] In an application, when the distal portion of the anchor driver is in the first flexible state, the anchor engagement head is configured to pivot relative to the distal portion of the elongate, propellable element.

[0082] In an application, the elongate, propellable element is shaped to define a flexible tube having a lumen, and the device further includes a shaft slidable relative to the flexible tube to control the flexibility of the flexible tube.

[0083] In an application, the shaft is stiffer than the flexible tube.

[0084] In an application, the shaft is slidable within the lumen of the flexible tube such that the distal portion of the anchor driver assumes the second flexible state, and the shaft is retractable distally from the lumen of the flexible tube at least to the distal portion of the elongate, propellable element such that the distal portion of the anchor driver assumes the first flexible state.

[0085] In an application, the anchor engagement head is hingedly attachable relative to the elongate, propellable element.

[0086] In an application, the system and / or device further includes a coupling pin coupled to the distal end of the elongate, propellable element, and the anchor engagement head is shaped to define at least one slot opening, and the coupling pin and the slot opening are movable relative to each other to facilitate hinging between the anchor engagement head and the elongate, propellable element.

[0087] In an application, the slot opening is shaped to define at least one end section and a main section wider than the end section, and when the coupling pin is disposed within the end section, the relative movement between the anchor engaging head and the elongated propelling element is restricted and the distal portion of the anchor driver assumes a second flexible state. Additionally, in some applications, when the coupling pin is disposed within the main section, the relative movement between the anchor engaging head and the elongated propelling element is facilitated and the distal portion of the anchor driver assumes a first flexible state.

[0088] In an application, the main section has a first width that is 1.5 - 2 times wider than the end section.

[0089] In an application, the elongated propelling element is rotatable relative to the anchor engaging head about the longitudinal axis of the distal portion of the elongated propelling element so as to shift the coupling pin between the main section and the end section.

[0090] According to some applications, a method is also provided that includes reversibly engaging the anchor engaging head of an anchor driver with a tissue anchor. The anchor driver and the tissue anchor can be the same as or similar to other anchor drivers and tissue anchors described herein. In some embodiments, the anchor driver includes an elongated propelling element that is coupled at its distal end to an anchor coupling element and that has a distal portion. In some embodiments, the anchor driver has a distal portion that has a first flexible state and a second flexible state that is less flexible than the first flexible state.

[0091] The method may further include, after the engagement, shifting the distal portion of the anchor driver to the first flexible state.

[0092] In an application, before engaging the anchor engaging head of the anchor driver with the tissue anchor, the distal portion of the anchor driver is shifted from the first flexible state to the second flexible state.

[0093] In an application, during the engagement, the distal portion is in the second flexible state and the shift includes shifting the distal portion of the anchor driver from the second flexible state to the first flexible state.

[0094] In an application, the method further includes disengaging the anchor engaging head from the tissue anchor and during the disengagement, the distal portion of the anchor driver is in the second flexible state.

[0095] In an application, when the distal portion of the anchor driver is in the first flexible state, the anchor engaging head and the distal portion of the elongated propelling element are pivoted relative to each other.

[0096] In an application, the method further includes driving the tissue anchor into a subject's tissue (e.g., heart tissue, heart valve tissue, vasculature tissue, muscle tissue, etc.), and the method further includes applying torque to the elongate pushable element, and during the application of the torque, a distal portion of the anchor driver is in a second flexible state.

[0097] In an application, the method further includes advancing the elongate pushable element through a subject's vasculature, and during the advancement, a distal end of the anchor driver is in a first flexible state, and before applying the torque, transitioning the distal portion of the anchor driver from the first flexible state to the second flexible state.

[0098] In an application, the elongate pushable element is shaped to define a flexible tube having a lumen, and the method further includes controlling the flexibility of the flexible tube by sliding a shaft relative to the flexible tube.

[0099] In an application, the shaft is stiffer than the flexible tube.

[0100] In an application, the method further includes hinging the anchor engaging head and the elongate pushable element relative to each other.

[0101] In an application, a distal end of the elongate pushable element includes a coupling pin, and the anchor engaging head is shaped to define at least one slot opening, and the method further includes facilitating the hinging by promoting movement between the coupling pin and the at least one slot opening.

[0102] In an application, the slot opening is shaped to define at least one end section and a main section wider than the end section, and transitioning the distal portion of the elongate pushable element to the first flexible state includes promoting movement between the coupling pin and the at least one slot opening when the coupling pin is disposed within the main section.

[0103] The method may further include transitioning the distal portion of the anchor driver to the second flexible state by promoting positioning of the coupling pin within the end section and restricting movement by positioning the anchor engaging head and the elongate pushable element relative to each other.

[0104] In an application, the main section has a first width that is 1.5 - 2 times wider than the end section.

[0105] In an application, the elongate pushable element is rotatable relative to the anchor engaging head about a longitudinal axis of a distal portion of the elongate pushable element, and transitioning the distal portion of the anchor driver to the first flexible state includes rotating the elongate pushable element relative to the anchor engaging head and moving the coupling pin from the end section to the main section by the rotation.

[0106] In an application, after transforming the distal portion of the anchor driver into a first flexible state, the distal portion of the anchor driver is transformed into a second flexible state by rotating the elongate propelling element relative to the anchor engaging head, and the coupling pin is moved from the primary section to the end section by rotation.

[0107] In an application, moving the coupling pin from the primary section to the end section includes locking the anchor engaging head relative to the distal portion of the elongate propelling element.

[0108] The method including its respective steps can be performed as part of training or simulation (e.g., may involve simulating tissue, etc.).

[0109] According to some applications, there is also provided a system and / or device for use with a tissue anchor, the system and / or device including an anchor access device having a housing. In some applications, the anchor access device and / or its housing are shaped to define a passage having an anchor storage partition or area and a proximal opening.

[0110] In some applications, the anchor access device and / or its housing include a retaining member in the passage of the anchor access device. The retaining member can have a retaining state in which the retaining member is configured to hold the tissue anchor in the anchor storage partition. In some applications, the retaining member is configured to allow the tissue anchor to leave the anchor storage partition / area in response to a force applied to the tissue anchor. In some embodiments, the force is a proximally directed force, and the retaining member is configured to allow the tissue anchor to leave the anchor storage partition / area in response to the proximally directed force by moving in response to the proximally directed force applied to the tissue anchor. In some embodiments, the proximally directed force is greater than a predetermined threshold force, and / or the retaining member is configured such that the predetermined threshold force is less than a desired amount of the proximally directed force.

[0111] In some applications, the retaining member is shaped to define a bracket at its proximal end, the bracket defining a first inclined surface and a second inclined surface, the first surface and the second surface being configured to abut against the tissue anchor such that the anchor fits snugly in the anchor storage partition.

[0112] In an application, the first inclined surface and the second inclined surface are adjacent to form a vertex of the bracket.

[0113] In an application, the first inclined surface and the second inclined surface form a substantially "V" shape.

[0114] According to some applications, there is also provided a system and / or device for use with a tissue anchor, the system / device including an anchor access device having a housing. The system / device and / or its housing is shaped to define a passage having an anchor storage compartment / area and a proximal opening.

[0115] In some embodiments, the system / device and / or its housing includes a retaining member disposed within the passage of the anchor access device. In some embodiments, the retaining member has a longitudinal axis and a retaining state in which the retaining member is configured to hold the tissue anchor within the anchor storage compartment. The retaining member can be configured to allow the tissue anchor to move out of the anchor storage compartment in response to a force (e.g., a proximally directed force, etc.) applied to the tissue anchor by moving in response to the force. The force (e.g., a proximally directed force, etc.) can be greater than a predetermined threshold force, and / or the retaining member can be configured to release the tissue anchor in response to a force above the predetermined threshold force.

[0116] In some embodiments, a pivot is coupled to the retaining member, the pivot including a support post that can be coupled to the tissue anchor, the pivot being configured to pivot the support post and the tissue anchor away from the longitudinal axis of the retaining member.

[0117] In an application, the anchor is shaped to define a lumen, and the support post is shaped to define a rod that fits within the lumen of the tissue anchor.

[0118] Additional features, components, steps, etc. can be incorporated into the systems, devices, methods, etc. described in this Summary of the Invention.

[0119] The present invention will be more fully understood in conjunction with the accompanying drawings, through the following detailed description of the present application, wherein: BRIEF DESCRIPTION OF THE DRAWINGS

[0120] Figures 1 - 2 and Figures 3A - 3C is a schematic view of an example of an anchor access device according to some applications, the anchor access device being configured to facilitate access to at least one tissue anchor;

[0121] Figures 4A - 4B 、 Figures 5A - 5B and Figures 6A - 6C are schematic views of examples of corresponding pins according to some applications, the pins being shaped to define brackets for supporting and clamping corresponding tissue anchors;

[0122] Figures 7A - 7C 、 Figure 8 、 Figure 9 and Figures 10A - 10B are schematic views of examples of wearable articles according to some applications, the wearable articles being coupled to a clamp that holds the anchor access device;

[0123] Figures 11A - 11B is a schematic view of an example of an elongate, propellable element of an axially enhanced anchor driver according to some applications; and

[0124] Figure 12 、 Figures 13A - 13C and Figures 14A - 14B is a schematic view of an example of an anchor driver pivotally rotatable relative to a tissue anchor according to some applications. DETAILED DESCRIPTION

[0125] Referring Figures 1 - 2 and Figures 3A - 3C to FIGS. and, which are schematic views of a system 10 according to some applications including an anchor access device 20 (e.g., a reservoir, a magazine, a carrier, etc.) configured to facilitate access to at least one tissue anchor 40. As shown, the device 20 is configured to access a plurality of anchors 40, and for such applications, the device 20 defines a multi-anchor access device. The device 20 includes a housing 22 defining a channel 24, an anchor storage compartment 26 (e.g., at the proximal end of the channel), and an opening 28 (e.g., at the proximal end of the channel) providing access to the channel and the anchor storage compartment. There may be a smooth transition between the anchor storage compartment 26 and the channel 24. The device 20 also includes a retaining member, such as a pin 30, configured to hold the tissue anchor 40 in the compartment 26 and to stop holding the tissue anchor in response to a sufficient force (e.g., a proximally directed force) applied to the tissue anchor. That is, when a force greater than a predetermined threshold force or a proximally directed force greater than a predetermined threshold force is applied to the tissue anchor 40, the retaining member stops holding (e.g., releases) the tissue anchor.

[0126] In some embodiments, the retaining member (e.g., pin 30) has a retaining state in which the retaining member holds the tissue anchor 40 within the compartment 26, and the retaining member is moved out of the retaining state when a sufficient proximally directed force is applied to the tissue anchor. Figure 1 The pin 30 is shown in its retaining state according to some applications, in which at least a portion 29 (e.g., a restricting portion and / or a distal portion) of the pin is disposed within a cavity 32 (e.g., distally of the anchor 40) to hold the anchor in the compartment 26 by restricting proximal movement of the tissue anchor (described below). As Figure 2 shown, the device 20 may include two housing portions 22a and 22b that are adjacent to each other. Each housing portion 22a and 22b is shaped to define a plurality of cavities 32.

[0127] The housing 22 of device 20 can be shaped to define a plurality of channels 24, each of the plurality of channels having a corresponding anchor storage compartment / region 26 and a corresponding proximal opening 28. In some embodiments, device 20 includes a plurality of tissue anchors 40 that are slidable through corresponding channels 24 and are configured to be stored in the corresponding anchor storage compartments / regions. Accordingly, device 20 includes a plurality of retaining members, such as pins 30. Each retaining member can be configured to hold a corresponding tissue anchor 40 in the corresponding anchor storage compartment / region 26 and to allow the corresponding tissue anchor 40 to leave the corresponding anchor storage compartment / region 26 in response to a force applied to the corresponding tissue anchor 40 (e.g., a proximally directed force).

[0128] A variety of tissue anchors can be used that can have a variety of configurations, shapes, and sizes. In some embodiments, tissue anchor 40 is shaped to define a core 41 and a tissue engaging member 44. Tissue anchor 40 can be sized to fit snugly within the anchor storage compartment 26 of the housing. The tissue anchor (e.g., its core 41) can be sized to slide snugly through the channel 24 of the housing, and for some applications, this snug sliding prevents the tissue engaging member 44 of the anchor from contacting the housing (e.g., the wall of the channel) as the anchor moves through the channel. At least a portion of the pin can be sized to slide snugly through the chamber.

[0129] As Figures 3A - 3B shown, the retaining member (e.g., pin 30) has a retaining state in which the retaining member holds the tissue anchor 40 within compartment 26. When sufficient force (e.g., sufficient proximally directed force) is applied to the tissue anchor, the retaining member can be moved out of the retaining state. Figures 3A - 3B Pin 30 is shown in its retaining state for some applications, in which at least the distal portion of the pin is disposed within the channel of chamber 25 (e.g., distally of anchor 40), thereby holding the anchor within compartment 26 by restricting proximal movement of the tissue anchor. Chamber 25 is defined by housing 22 and can be in fluid communication with channel 24 (e.g., in the absence of pin 30). In some embodiments, chamber 25 has a central longitudinal axis that is parallel to the central longitudinal axis of channel 24.

[0130] It should be noted that while pin 30 is shown as being generally rectangular (i.e., having a generally rectangular cross-section), the term "pin" as used throughout this application, including the specification and claims, can include pins having different shapes (e.g., having a circular cross-section). Pin 30 includes a first leg and second legs 33 and 35 that can be compressed radially inwardly and toward each other and toward the longitudinal axis 27 of channel 24 and chamber 25 in response to a compressive force applied thereto.

[0131] Figure 3C Illustrated is an anchor 40 withdrawn proximally from a partition 26 of a channel 24 by sufficient force or sufficient proximally-directed force applied to the anchor by an anchor driver 60. In response to sufficient force or sufficient proximally-directed force applied to the tissue anchor (i.e., if the force or proximally-directed force is greater than a predetermined threshold force), a retention member (e.g., pin 30) stops retaining the tissue anchor in the partition 26. For example, and as Figure 3C shown, the sufficient force or sufficient proximally-directed force overcomes the retention force provided by the pin 30 and legs 33 and 35 of the pin being compressed towards each other.

[0132] It is assumed that this configuration of the device 20 requires sufficient force or sufficient proximally-directed force to be applied to the tissue anchor 40 to prevent unintentional movement and / or withdrawal of the tissue anchor (e.g., due to general transportation or access of the device), and / or withdrawal of the anchor when the driver is not optimally coupled to the anchor.

[0133] After the anchor 40 is removed from the channel 24, the proximal portion of the pin 30 remains exposed from the opening 28. This is particularly useful for a doctor using a multi-anchor access device (e.g., device 20), e.g., to prevent the doctor from inadvertently attempting to obtain an anchor from an empty partition 26. That is, the proximal portion of the pin 30 serves as an empty-shell indicator.

[0134] Now refer to Figures 4A - 4B 、 Figures 5A - 5B and Figures 6A - 6C which are schematic views of corresponding pins 30 according to some applications, the pin 30 being shaped to define a bracket 50 at its proximal end for cradling and gripping the corresponding tissue anchor 40. As Figures 4A - 4BAs shown, the bracket 50 is shaped to define a first inclined surface and a second inclined surface 51a and 51b. For some applications, the inclined surfaces 51a and 51b are adjacent to form a vertex 52 of the bracket 50. For some applications, a narrow horizontal surface connects the bottom edges of the inclined surfaces 51a and 51b such that three surfaces of the bracket 50 contact the anchor 40. For some applications, a narrow curved or semi-circular surface connects the bottom edges of the inclined surfaces 51a and 51b such that three surfaces of the bracket 50 contact the anchor 40. For clarity of illustration, the anchor 40 is not shown. The surfaces 51a and 51b are configured to abut against the anchor 40 such that the anchor 40 fits snugly within the anchor storage partition 26. As shown, the first inclined surface and the second inclined surface 51a and 51b together form a generally "V"-shaped cross-section, as shown. For some applications, the surfaces 51a and 51b are curved such that the bracket 50 forms a semi-circular cross-section. In any embodiment, the surfaces 51a and 51b are configured to contact as much of the surface area of the anchor 40 as possible to support the longitudinal length of the anchor 40 and prevent translation of the anchor 40. Since the anchor 40 is typically rigid, the surfaces 51a and 51b contact as much of the surface area of the anchor 40 as possible to distribute the load.

[0135] For some applications, the surfaces 51a and 51b support only the core 41 of the anchor 40. For some applications, the surfaces 51a and 51b support the entire anchor 40 including the core 41 and the tissue engaging member 44.

[0136] Figures 5A - 5B Shown is a bracket 50 that defines a first straight surface and a second straight surface 53a and 53b that are coupled to a flat base 55 such that three surfaces of the bracket 50 contact the anchor 40. For some applications, the base 55 defines a narrow curved or semi-circular surface that connects the bottom edges of the straight surfaces 53a and 53b such that three surfaces of the bracket 50 contact the anchor 40. For clarity of illustration, the anchor 40 is not shown. The surfaces 53a and 53b and the base 55 are configured to abut against the anchor 40 such that the anchor 40 fits snugly within the anchor storage partition 26. In any embodiment, the surfaces 53a and 53b and the base 55 are configured to contact as much of the surface area of the anchor 40 as possible to support the longitudinal length of the anchor 40 and prevent translation of the anchor 40. Since the anchor 40 is typically rigid, the surfaces 53a and 53b and the base 55 contact as much of the surface area of the anchor 40 as possible to distribute the load.

[0137] For some applications, the bracket 50 is shaped to define only the base 55 and not the surfaces 53a and 53b.

[0138] For some applications, surfaces 53a and 53b support only the core 41 of the anchor 40. For some applications, surfaces 53a and 53b support the entire anchor 40 including the core 41 and the tissue engaging member 44.

[0139] For Figures 4A - 4B and Figures 5A - 5B any of the brackets 50 shown, for some applications, the bracket 50 includes a pivot support post 57, as Figures 6A - 6C shown, once the bracket 50 of the pin 30 is exposed and in response to at least partial proximal pulling of the pin 30 from within the channel 24 and exposure from within the anchor storage partition 26, the pivot support post 57 enables the anchor 40 to pivot. The pivot post 57 may extend within the tissue engaging member 44 and enable the anchor 40 to be articulated and pivot away from the bracket 50. As shown, the member 44 is shaped to define a helix, and the post 57 is disposed within the lumen defined by the helix. Additionally, the post 57 provides support and distributes load for the tissue anchor 40. The post 57 is shaped to define a rod. For such applications, the pin 30 is shaped to define a pivot pin 59 or pivot coupled to the pivot post 57 that enables the pivot post to facilitate angular pivoting of the tissue anchor 40 away from the bracket 50, e.g., angularly away from the longitudinal axis of the retaining member.

[0140] Now refer to Figures 3A - 3C 、 Figures 4A - 4B and Figures 5A - 5B 。In the application shown, the device 20 includes a detent configured to configure a retaining member (e.g., the pin 30) to (i) hold the tissue anchor within the anchor storage partition 26, and (ii) stop holding the tissue anchor in response to sufficient force or sufficient proximally directed force. The distal portion of each pin 30 is shaped to define a first leg and a second leg 33 and 35. Each leg may include or define a respective at least one ratchet at its distal portion. For example, each leg 33 and 35 of the pin 30 includes a portion 29 that serves as a ratchet, while the anchor 40 is disposed within the anchor storage partition 26 and is clamped within a cavity 32 (e.g., a notch) defined within the chamber 25 by a spring mechanism and thus serves as a detent. Additionally, each leg 33 and 35 of the pin 30 includes or defines a second ratchet 31. For some applications, at least a portion of the retaining member (e.g., the pin 30) is elastic to provide the spring mechanism. However, it should be noted that other spring mechanisms are possible. Since the legs 33 and 35 can be radially inwardly compressed towards each other, the legs 33 and 35 also serve as a spring mechanism.

[0141] As Figure 3A shown, for each channel 24, the housing 22 is shaped to define a respective convex coupling 39 near the cavity 32. As Figure 2As shown, each lateral portion 22a and 22b of the outer shell 22 is shaped to define a respective cavity 32 in fluid communication with the channel 24 and / or the chamber 25. During the holding state of the holding member (e.g., the pin 30), the pin 30 is configured to hold the anchor 40 in the anchor storage partition 26. During the holding state, the pawls or portions 29 of each leg 33 and 35 are maintained within the respective cavities 32 of the outer shell 22. Additionally, the portions 29 and the pawls 31 of each leg 33 and 35 of the pin 30 surround and embrace the convex coupling member 39. In this way, the portion 29 serves as a restrictor. The restrictor provides a resistance that (i) inhibits the sliding of the pin 30 through the chamber 25, e.g., prevents the sliding of the pin in the absence of sufficient proximally-directed force (e.g., as shown in Figures 3A - 3B ), and (ii) stops inhibiting the sliding in response to sufficient proximally-directed force by the pawl 31 moving proximally away from the convex coupling member 39 and into the cavity 32 (e.g., as shown in Figure 3C ). For example, and as shown, the resilient portions (e.g., the legs 33 and 35) deform (e.g., bend or move) in response to sufficient proximally-directed force. In this way, the legs 33 and 35 move towards each other. This can be facilitated by the pawls 31 of each leg 33 and 35 and the convex coupling member 39. Since each pawl 31 has a properly angled or inclined face 37, the proximally-directed force is translated into a lateral movement of the pawl 31 proximally around the convex coupling member 39 and into the cavity 32, as shown in Figure 3C . For example, and as shown, the pawl 31 can have a beveled edge.

[0142] For such an application, once the pawl 31 has moved into the cavity 32, a proximally-directed force less than a threshold force is sufficient to move the pin 30 further proximally. That is, once the initial resistance provided by the restrictor is overcome, the anchor 40 can be withdrawn further using a force less than the force required to overcome the initial resistance.

[0143] (Those skilled in the art will understand that it is possible to use other configurations to achieve similar performance as described above. For example, the outer shell 22 can define a protrusion (e.g., a pawl) and the pin 30 can include a cavity (e.g., a notch) into which the protrusion extends.)

[0144] Due to the inclined face 37 of the pawl 31, a distal force can be applied to push the pin 30 back to Figures 3A - 3BThe retention state shown. That is, once the anchor 40 is removed from the bracket 50, a new anchor 40 can be reloaded into the bracket 50 of the pin 30, and the pin 30 can be pushed distally into the channel 24 of the housing 22 such that the newly loaded anchor 40 is positioned within the anchor storage compartment 26 of the housing 22. That is, when a distally directed force greater than a predetermined threshold force is applied to the pin 30 and / or to the tissue anchor 40 newly loaded into the bracket 50, the pin 30 is capable of retaining the new anchor 40.

[0145] For some applications, the housing 22 defines therein a second cavity (not shown) that is disposed proximal to the cavity 32. Once the pin 30 is moved proximally, the portion 29 engages the second cavity while the pawl 31 is disposed within the cavity 32. In some applications, the housing 22 is at least partially transparent to enable observation of the coupling of the anchor driver to the anchor 40 and / or the withdrawal of the anchor from the housing. For such applications, for each pin, the housing 22 defines a first cavity, a second cavity, a third cavity, and a fourth cavity. The portion 29 engages the first and second cavities and the pawl 31 engages the third and fourth cavities.

[0146] Now referring to Figures 7A - 7C , Figure 8 , Figure 9 and Figures 10A - 10B , which are schematic views of a wearable article 100 coupled to a gripper 90 according to some applications, the gripper 90 being shaped to define a space 92 for receiving the anchor access device 20. The gripper 90 is shaped to define a housing (e.g., a cradle, as shown) and a coupler 94 that is configured to reversibly couple the anchor access device 20 to the gripper 90. The wearable article 100 is configured to temporarily attach the anchor access device 20 to the body of a surgeon using the anchor access device.

[0147] The bracket 90 can be shaped to define two scaffolding lateral arms that create two openings at opposite ends of the bracket 90. That is, even though the device 20 is shown entering and exiting an opening at the first end of the gripper 90 in Figures 7A - 7C , it should be noted that the device 20 can also enter and exit the opposite opening at the other end of the housing 90. It should be noted that for some applications, one end of the gripper 90 can be closed while the opposite end is open (configuration not shown).

[0148] For some applications, the wearable item 100 includes an adhesive configured to temporarily attach the anchor access device 20 to a surgeon's clothing. For some applications, the wearable item 100 includes an adhesive configured to temporarily attach the anchor access device 20 to a surgeon's glove. For some applications, the wearable item 100 includes a hook-and-loop fastener configured to temporarily attach the anchor access device 20 to a surgeon's clothing. For some applications, the wearable item 100 includes a hook-and-loop fastener configured to temporarily attach the anchor access device 20 to a surgeon's glove. Note that any suitable device (such as a magnet, pin, etc.) can be used to temporarily attach the anchor access device 20 to the doctor.

[0149] For some applications, the wearable item 100 includes a thin metal sheet. For some applications, the thin metal sheet is malleable to conform the item 100 to a particular part of the surgeon's body.

[0150] Now refer to Figure 8 , Figure 9 and Figures 10A - 10B . For some applications, the wearable item 100 includes a strap 102. For some applications, the wearable item 100 includes a wristband. In some embodiments, the strap 102 is flexible. For some applications, the strap 102 includes a stretchable material. For some applications, the strap 102 includes a shape memory material. For some applications, the item 100 (such as the strap 102) includes a rigid material at at least a portion thereof near the gripper 90.

[0151] For some applications, the strap 102 includes a closed loop and is stretchable to pass over or slide onto a surgeon's hand such that the surgeon can wear the device 20 on his / her wrist or around a portion of the central part of the surgeon's hand. For some applications, the strap 102 includes a first portion and a second portion, the first portion including a stretchable and flexible material and the second portion including a material that is less stretchable and less flexible compared to the stretchable and flexible material of the first portion. For such applications, the strap 102 is variably stretchable and variably flexible. For such applications, the second portion can be near the gripper 90. For some applications, the more flexible and more stretchable sections of the strap 102 are arranged in the transverse portion of the strap, e.g., not near the gripper 90.

[0152] As Figure 10AAs shown, the strap 102 includes a first end and a second end 103. For some applications, the first end and the second end 103 are separable, for example, by using an adjustment mechanism 104 coupled to the wearable item 100 near the gripper 90 to separate the first and second portions (e.g., halves) of the strap 102. The adjustment mechanism 104 includes a spring-loaded coupler 106 that allows the two portions of the strap 102 to expand and move away from each other. Due to the presence of the spring-loaded coupler 106, the portions of the strap 102 tend to move closer to each other to facilitate contraction of the strap 102 and facilitate a snug coupling of the device 20 to the surgeon. Details of the spring-loaded coupler 106 are shown in Figure 10B as shown.

[0153] As Figure 8 shown, the strap 102 can be adjusted using a buckle 112. As Figure 8 shown, the buckle 112 is shaped to define a plurality of openings in one portion of the strap 102, while the strap 102 is shaped to define a coupler (not shown) in the opposing portion of the strap 102 that engages any one of the openings of the buckle 112. For some applications, the buckle 112 includes a magnet and magnetically fastens the ends of the strap 102. For either embodiment, the size of the strap 102 is adjustable.

[0154] For some applications, the system 10 includes a design in which a single strap 102 can be wrapped around both the wrist and the central portion of the hand of the surgeon. For some applications, the system 10 includes a multi-strap design in which two or more straps are used to wrap around the wrist and the central portion of the hand of the surgeon. In either embodiment, the multi-wrap or multi-strap design provides greater stability during use of the device 20.

[0155] Now refer to Figure 8 and Figure 9 and Figures 10A - 10B . For some applications, the strap 102 includes an adhesive to prevent the wearable item 100 from moving or sliding relative to the body of the surgeon.

[0156] Now refer to Figures 7A - 7C and Figures 10A - 10B . The gripper 90 is shaped to define a space 92 for receiving the anchor access device 20 and includes a coupler 94 that is configured to reversibly couple the device 20 to the gripper 90 and thus reversibly couple to the wearable item 100. In some embodiments, the coupler 94 includes a convex coupler that projects into the space 92. For some applications, the coupler 94 is rigid. For some applications, the coupler 94 includes a pawl that is movable relative to the wall of the gripper 90 in response to a force applied to the pawl, for example, through the housing 22 of the device 20.

[0157] The device 20 is shaped to define a concave coupler 84 (e.g., a cavity) that is shaped to receive a convex coupler 94 of the gripper 90 to facilitate reversible locking of the anchor access device 20 to the gripper 90.

[0158] The anchor access device 20 includes a pawl 82 that is movable in response to a force applied to the pawl 82 by the convex coupler 94 of the gripper 90 to facilitate reversible locking of the anchor access device 20 to the gripper 90. As Figure 7A shown, the pawl 82 is disposed in its rest and locked position distal to the convex coupler 94 to lock the device 20 in place. The anchor access device 20 includes a depressible element 80 coupled to the pawl 82. As shown, the device 20 is shaped to define corresponding pawl 82 and depressible element 80 at two lateral sides of the housing 22. As Figure 7B shown, the depressible element 80 can be pushed by a surgeon to apply an inward force to the pawl 82 such that the pawl 82 disengages from the convex coupler 94 of the gripper 90. Once the pawl 82 is not engaged with the convex coupler 94 of the gripper 90, the device 20 can be moved proximally away from the gripper 90 such that the device 20 is separated from the gripper 90, as Figure 7C shown. At this time, no force is applied to the depressible element 80 and the pawl returns to its rest position.

[0159] The device 20 can then be re-coupled to the gripper 90. For some applications, when the device 20 is moved distally into the space 92 of the gripper 90, the depressible element 80 is pushed inward to move the pawl inward to disengage from the convex coupler 94. For some applications, the pawl moves in response to distal movement of the housing 22 of the device 20 against the convex coupler 94 of the gripper 90.

[0160] Referring again to Figure 8 、 Figure 9 and Figures 10A - 10B . For some applications, a hinge coupler (e.g., a swivel coupler) couples the gripper 90 to the wearable article 100 such that the gripper is hingeable (e.g., rotatable) relative to the wearable article. For some applications, a first portion of the wearable article 100 is stiffer than a second portion of the wearable article 100. For such applications, the second portion of the wearable article 100 imparts flexibility and stretchability to the article 100.

[0161] Figure 9It is shown that the anchor 40 has been completely withdrawn from the channel 24 via the opening 28. The anchor driver 60 is brought towards the gripper 90 and the wearable article 100 (such as the shown strap 102) so as to engage the driver 60 with the anchor disposed within the device 20. As described above, the driver 60 withdraws the anchor 40. Once the anchor 40 has been completely withdrawn, the driver 60 can be used to anchor the tissue anchor 40 to the tissue of a subject, for example, by driving the tissue engaging member 44 of the anchor into the tissue.

[0162] A variety of tissue anchors known in the art can be used.

[0163] In some embodiments, using the driver 60, the anchor 40 can be advanced through an endoluminal implant delivery system and used to couple an implant (such as an annuloplasty structure) to the tissue of a subject.

[0164] In some embodiments, the driver 60 includes an anchor engaging head 62 at the distal end of the driver, and an elongate pushable element 64 proximal to the anchor engaging head. For some applications, the elongate pushable element 64 includes a tube shaped to define a lumen. For some applications, the elongate pushable element 64 includes a shaft. The elongate pushable element 64 is flexible and pushable (e.g., transcatheter) through the vasculature of a subject, and can have a length greater than 20 cm and / or less than 2.5 m, such as greater than 50 cm and / or less than 1.5 m, such as between 0.9 m and 1.2 m. For some applications, the driver 60 includes a handle (not shown) at the proximal end of the elongate pushable element 64, the handle including a regulator (such as a switch or lever) configured to actuate the engaging head 62.

[0165] Figure 9 It is shown that the anchor 40 has been completely removed from the housing. For some applications, to facilitate complete disengagement of the anchor 40 from the pin 30, the anchor is moved slightly laterally relative to the pin 30. For some applications, the pin 30 includes a pivot post 57, as described above with reference to Figures 6A - 6C Once the anchor 40 has been completely withdrawn, the driver 60 can be used to anchor the tissue anchor 40 to the tissue of a subject.

[0166] As Figure 9 As shown, two anchors 40 have been removed from the device 20. After removal of the anchor 40, the proximal portion of the corresponding pin 30 protrudes from the corresponding opening 28 and serves as an indicator of how many anchors have been removed from the device 20. For some applications, new anchors can be reloaded into the device by placing them in the holder of the pin 30 exposed from within the housing 22 of the device 20.

[0167] Now refer toFigures 11A - 11B , which are schematic diagrams of an anchor driver 60 that is advanced through a patient's vasculature for some applications. The anchor driver includes an elongate pushable element 64. For such applications, the elongate pushable element 64 may include a flexible, elongate tube. The distal end of element 64 is coupled to an anchor engagement head 62. A shaft 66 is pushable through the lumen of the tube of element 64. In some embodiments, the shaft 66 is stiffer than the element 64.

[0168] The shaft 66 is slidable proximally and distally relative to the tube of the element 64. When the distal portion of the element 64 is without the shaft 66 (as Figure 11A shown), the distal portion of the element 64 is more flexible and less rigid, and thus the distal portion of the anchor driver 60 is more flexible and less rigid, and enables a greater range of motion of the anchor engagement head 62. When the distal portion of the element 64 is without the shaft 66, the anchor driver 60 (or at least the distal portion of the element 64) is in a more flexible state.

[0169] Once the surgeon advances the shaft 66 within the distal portion of the tube of the element 64, the distal portion of the element 64 is less flexible and more rigid. The presence of the shaft 66 within the lumen of the tube of the element 64 (as Figure 11B shown) reduces the ability of the tube of the element 64 to bend. When a portion of the shaft 66 is within the lumen of the distal portion of the element 64, the anchor driver 60 (or at least the distal portion of the element 64) is in a less flexible state.

[0170] During navigating the anchor driver 60 through the vasculature and manipulating the distal portion of the anchor driver 60 along the tissue of the annulus of the valve to a proper position, the increased flexibility of the element 64 is useful. Thus, during these steps, the shaft 66 is not present within the lumen of the tube of the element 64, as Figure 11A shown. During these steps, the distal end of the elongate pushable element 64 and the distal portion of the anchor driver 60 are in a first flexible state (as Figure 11A shown).

[0171] In some applications, during connecting the anchor driver 60 to the anchor within the anchor access device 20 as described above, and during rotating the element 64 and applying torque to the element 64, the shaft 66 is positioned within the lumen of the tube of the element 64 to apply torque to the anchor 40 during inserting the anchor 40 into the tissue (e.g., driving the anchor 40 into the tissue) and removing the anchor 40 from the tissue. During these steps, the distal end of the elongate pushable element 64 and the distal portion of the anchor driver 60 are in a second flexible state that is less flexible than the first flexible state (as Figure 11BAs shown). In the second flexible state, the distal portions of the element 64 and the anchor driver 60 are more rigid.

[0172] Thus, longitudinal proximal and distal movement of the shaft 66 relative to the element 64 facilitates transition of the distal end of the elongate, advanceable element 64 between a first flexible state and a second flexible state.

[0173] As Figure 11A shown, when the element 64 is without the shaft 66, pivoting, tilting, movement, bending, flexing, or articulation of the distal portion of the element 64 increases and the distal portions of the elongate, advanceable element 64 and the anchor driver 60 assume a more flexible state. That is, the head 62 is permitted to pivot, tilt, move, bend, flex, or articulate relative to the distal portion of the elongate element 64.

[0174] For some applications, the anchor driver 60 is assembled such that the shaft 66 is disposed within the lumen of the element 64 (as Figure 11B shown). During coupling of the anchor driver 60 to the tissue anchor 40 (e.g., as described above with reference to Figures 1 - 6C ), it is advantageous for the driver 60 to be in a less flexible state, as Figure 11B shown. The anchor driver 60 is then transitioned to a more flexible state by retracting the shaft 66 from at least the distal portion of the elongate, advanceable element 64 (as Figure 11A shown). In this state, the anchor driver 60 is more flexible. This more flexible state of the anchor driver 60 ( Figure 11A shown) is advantageous during navigating the anchor driver 60 through the vasculature and manipulating the distal portion of the anchor driver 60 along the tissue of the annulus of the valve to an appropriate position. Once the anchor driver 60 has delivered the anchor 40 to the appropriate position in the tissue, the anchor driver 60 is transitioned to a less flexible state by advancing the shaft 66 within the distal portion of the element 64 (as Figure 11B shown) to impart rigidity to the anchor driver 60 when torque is applied to the elongate, advanceable element 64 in order to apply torque to the anchor 40 to drive the anchor 40 into the tissue. Transition of the anchor driver 60 between the more flexible and less flexible states is facilitated by distal and proximal sliding of the shaft 66 within the lumen of the element 64.

[0175] As Figure 11B shown, when the shaft 66 is disposed within the lumen of the distal portion of the elongate, advanceable element 64, the distal portion of the anchor driver 60 assumes a less flexible state. That is, pivoting, tilting, movement, bending, flexing, or articulation of the head 62 relative to the distal portion of the elongate element 64 is restricted, limited, or in some cases prevented.

[0176] During detachment of the anchor engagement head 62 from the tissue anchor 40, the shaft 66 is retracted to transition the anchor driver 60 to a more flexible state and impart additional flexibility to the distal end of the anchor driver 60 during flexure and bending of the element 64 relative to the now-implanted tissue anchor 40.

[0177] Now refer to Figure 12 、 Figures 13A - 13C and Figures 14A - 14B , which are schematic views of example anchor engagement heads 62 hinged relative to an elongate, axially advanceable element 64 for some applications. A variety of anchor driver designs and a variety of anchor engagement head designs are possible. In some applications, the distal end of the elongate, axially advanceable element 64 is coupled to at least one coupling pin 162 (e.g., a plurality of coupling pins 162 as shown). The anchor engagement head 62 can be shaped to define at least one slot opening 160 (e.g., a plurality as shown), and the coupling pin 162 and the slot opening 160 are movable relative to each other to facilitate hinging between the anchor engagement head 62 and the elongate, axially advanceable element 64.

[0178] Each slot opening 160 can be shaped to form a major section 166 and at least one circumferential end section 164 around a circumference. As shown, each opening 160 is shaped to define corresponding end sections 164 on either side of the major section 166. For some applications, the opening 160 can define a single end section 164. The major section 166 is wider longitudinally than each end section 164. For example, in some embodiments, the major section 166 is 1.5 - 2 times wider than the width of each end section 164. That is, the width of the section 166 measured along the longitudinal axis 165 of the distal portion of the elongate, axially advanceable element 64 is greater than the width of the section 164 measured along the axis 165. The opening 160 can be diamond-shaped or other shapes.

[0179] Now refer to Figures 13A - 13C . The elongate, axially advanceable element 64 is shown rotatable relative to the anchor engagement head 62 about the longitudinal axis 165 of the distal portion of the elongate, axially advanceable element 64 to transition the coupling pin 162 between the major section 166 and the end section 164.

[0180] As Figures 13A - 13B shown, when the coupling pin 162 is disposed within the major section 166, movement of the anchor engagement head 62 and the elongate, axially advanceable element 64 relative to each other is facilitated, and the distal portion of the elongate, axially advanceable element 64 and the distal portion of the anchor driver 60 assume a more flexible state. That is, pivoting, tilting, movement, bending, flexing, or hinging of the head 62 relative to the distal portion of the elongate element 64 is permitted.

[0181] For some applications, the anchor driver 60 is assembled such that the pin 162 is disposed within the end section 164 (as Figure 13C shown). During coupling of the anchor driver 60 to the tissue anchor 40 (e.g., as described above with reference to Figures 1 - 6C ), it is advantageous for the driver 60 to be in a less flexible state, as Figure 13C shown. The anchor driver 60 is then transitioned to a more flexible state by rotating the elongate pushable element 64 relative to the anchor engagement head 62 and by rotating and moving the coupling pin 162 from the end section 164 to the main section 166 ( Figures 13A - 13B shown). In this state, the anchor driver 60 is more flexible. This more flexible state of the anchor driver 60 ( Figures 13A - 13B shown) is advantageous during navigating the anchor driver 60 through the vasculature and manipulating the distal portion of the anchor driver 60 along the tissue of the annulus of the valve to the appropriate position. Once the anchor driver 60 has delivered the anchor 40 to the appropriate position in the tissue, the anchor driver 60 is transitioned to a less flexible state ( Figure 13C shown) by rotating the element 64 to move the pin 162 into the end section 164 to impart rigidity to the anchor driver 60 when torque is applied to the elongate pushable element 64 to apply torque to the anchor 40 to drive the anchor 40 into the tissue. The transition of the anchor driver 60 between the more flexible and less flexible states is facilitated by rotation of the element 64 relative to the head 62 and thereby affecting the movement of the pin 162 between the sections 164 and 166 of the opening 160.

[0182] As Figure 13C shown, when the coupling pin 162 is disposed within the end section 164, the relative movement between the anchor engagement head 62 and the elongate pushable element 64 is restricted and the distal portion of the elongate pushable element 64 and the distal portion of the anchor driver 60 exhibit a less flexible state. That is, pivoting, tilting, moving, bending, flexing, or articulating of the head 62 relative to the distal portion of the elongate element 64 is restricted, limited, or in some cases prevented. Moving the coupling pin 162 from the main section 166 to the end section 164 includes locking the anchor engagement head 62 relative to the distal portion of the elongate pushable element 64.

[0183] When the anchor driver 60 engages the anchor (e.g., from within the device 20 as described above), the coupling pin 162 is moved back into the main section 166 to transition the anchor driver 60 to a more flexible state and impart more flexibility to the distal end of the anchor driver 60.

[0184] During detachment of the anchor engagement head 62 from the tissue anchor 40, the coupling pin 162 is moved back into the primary section 166 to transition the anchor driver 60 to a more flexible state and impart more flexibility to the distal end of the anchor driver 60 during flexure and bending of the element 64 relative to the now-implanted tissue anchor 40.

[0185] Now refer to Figures 14A - 14B , which are schematic views of examples of an anchor engagement head 62 and an anchor retention rod 170 for some applications. The rod 170 is slidable within the lumen of the elongate, advanceable element 64 to reinforce the coupling between the anchor engagement head 62 and the tissue anchor 40. The tissue anchor 40 is shaped to define a coupling member 172 at the proximal end of the tissue anchor 40.

[0186] Now refer to Figure 12 and Figures 14A - 14B . In some applications, as shown, the anchor engagement head 62 is shaped to define a protrusion 150 that is shaped to fit within a space defined by the core 41 of the tissue anchor 40. The protrusion 150 is shaped to define a slot 152 for receiving the coupling member 172 of the tissue anchor 40. The anchor engagement head 62 has a longitudinal axis (i.e., axis 165 of the distal portion of the elongate, advanceable element 64), and the slot 152 is at a non-zero angle relative to the longitudinal axis. The anchor driver 60 pivots to engage the head 62 with the coupling member 172 of the anchor 40.

[0187] As Figure 14A shown, prior to engagement of the head 62 with the anchor 40, the distal end of the rod 170 may be disposed proximal to the slot 152. Once the engagement head 62 pivots to slide the coupling member 172 within the slot 152, the rod 170 may slide distally such that the distal end of the rod 170 slides within a portion of the slot 152 to reinforce the coupling between the anchor engagement head 62 and the tissue anchor 40 ( Figure 14B ). The rod 170 may also assist in reinforcing the coupling during attachment and insertion of the anchor 40 into tissue (e.g., corkscrewing, etc.). The distal portion of the rod 170 partially blocks the slot 152 to limit separation of the anchor 40 from the head 62.

[0188] Once the tissue anchor 40 has been inserted into tissue, the head 62 may be disengaged from the anchor 40 by pulling proximally on the rod 170 such that the distal end of the rod 170 is disposed proximal to the slot 152. The head 62 may then be pivoted and slid proximally such that the slot 152 slides proximally away from the coupling member 172.

[0189] Other designs of the tissue anchor and the anchor driver and mechanisms for attaching and releasing between them are also possible.

[0190] Now refer to Figures 1 - 14B For some applications, the device 20 is used in combination with one or more of the techniques described in one or more of the following references, all of which are incorporated herein by reference:

[0191] U.S. Patent Application 12 / 437,103, filed May 7, 2009 by Zipory et al., having publication number US2010 / 0286767. For example, (1) the device 20 of the present application can be used to facilitate the Figure 2 -FIG. 3 and / or Figures 6A - 12 techniques described, with necessary modifications; (2) the anchor driver 60 of the present application can include or correspond to the anchor driver 68 and / or the anchor deployment manipulator 24 of US2010 / 0286767 granted to Zipory et al., with necessary modifications; (3) the tissue anchor 40 of the present application can include or correspond to the anchor 38 of US2010 / 0286767 granted to Zipory et al., with necessary modifications; and / or (4) the implant 140 of the present application can include or correspond to the annuloplasty ring 22 of US2010 / 0286767 granted to Zipory et al., with necessary modifications.

[0192] U.S. Patent Application 12 / 689,635, filed January 19, 2010 by Zipory et al., having publication number US2010 / 0280604. For example, (1) the device 20 of the present application can be used to facilitate the Figure 2 -FIG. 3 and / or Figures 11A - 1 techniques described in 7, with necessary modifications; (2) the anchor driver 60 of the present application can include or correspond to the anchor driver 68 and / or the anchor deployment manipulator 24 of US2010 / 0280604 granted to Zipory et al., with necessary modifications; (3) the tissue anchor 40 of the present application can include or correspond to the anchor 38 of US2010 / 0280604 granted to Zipory et al., with necessary modifications; and / or (4) the implant 140 of the present application can include or correspond to the annuloplasty ring 22 of US2010 / 0280604 granted to Zipory et al., with necessary modifications.

[0193] The PCT patent application IL2012 / 050451 filed by Sheps et al. on November 8, 2013, with a publication number of WO2013 / 069019. For example, (1) the device 20 of the present application can be used to facilitate the Figures 14A - 1 techniques described in 4I of WO 2013 / 069019 granted to Sheps et al., with necessary modifications; (2) the system 120 of the present application can include or correspond to the system 10 of WO 2013 / 069019 granted to Sheps et al., with necessary modifications; (3) the anchor driver 60 of the present application can include or correspond to the anchor deployment manipulator 61 and / or the anchor driver 36 of WO 2013 / 069019 granted to Sheps et al., with necessary modifications; and / or (4) the implant 140 of the present application can include or correspond to the annuloplasty structure 222 and / or the cannula 26 of WO 2013 / 069019 granted to Sheps et al., with necessary modifications.

[0194] The PCT patent application IL2013 / 050860 titled "Controlled steering functionality for implant-delivery tool" filed by Sheps et al. on October 23, 2013, with a publication number of WO 2014 / 064694. For example, (1) the device 20 of the present application can be used to facilitate the Figures 10A - 1 0I, Figure 12 A- Figure 14B, the techniques described in FIGS. 18A - 18C, FIGS. 21 - 28, FIG. 34, and FIG. 36, with necessary modifications; (2) The system 120 of the present application may include or correspond to the system 10 of the PCT application titled "Controlled steering functionality for implant - delivery tool", with necessary modifications; The anchor driver 60 of the present application may include or correspond to the anchor deployment manipulator 61, the anchor driver 36, and / or the anchor driver 2338 of the PCT application titled "Controlled steering functionality for implant - delivery tool", with necessary modifications; and / or (4) The implant 140 of the present application may include or correspond to the annuloplasty structure 222 and / or the cannula 26 of the PCT application titled "Controlled steering functionality for implant - delivery tool", with necessary modifications.

[0195] The PCT patent application IL2013 / 050861 titled "Percutaneous tissue anchor techniques" filed by Herman et al. on October 23, 2013, with a publication number of WO 2014 / 064695. For example, (1) The device 20 of the present application can be used to facilitate the Figure 9 A - Figure 9 C and / or Figures 13A - 1 the techniques described in 3D, with necessary modifications; (2) The tissue anchor 40 of the present application may include or correspond to the tissue anchor 40 of the PCT application titled "Percutaneous tissue anchor techniques", with necessary modifications; and / or (3) The anchor driver 60 of the present application may include or correspond to the anchor driver 500, the anchor driver 236, the deployment manipulator 261, or the tool 80 of the PCT application titled "Percutaneous tissue anchor techniques", with necessary modifications.

[0196] Refer to Figures 1 - 14B. In some embodiments, a sterile anchor is provided within the anchor access device. As described above, for some applications, the anchor access device is configured such that returning an exposed portion of a retaining member into the housing requires a distally directed force that is greater (in the opposite direction) than twice the threshold force previously required to move the portion out of the housing. For example, the portion can be effectively prevented from moving back into the housing. In addition to facilitating use of the exposed portion as an empty shell indicator, this feature of the anchor access device discourages and / or prevents an operator from returning a previously removed anchor into the device, for example, thereby ensuring that only sterile anchors are disposed within the device.

[0197] For some applications, the anchor access devices described herein are configured to be at least partially submerged in saline prior to and / or during use, for example, to reduce the likelihood that air (e.g., bubbles) will be retained by the anchor and / or driver and subsequently introduced into the subject.

[0198] Those skilled in the art will appreciate that the present invention is not limited to what is specifically shown and described above. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications of the various features that are not prior art, which would occur to those skilled in the art after reading the foregoing description. In addition, the techniques, methods, operations, steps, etc. described herein may be performed on a living animal or a non-living simulation, such as a cadaver, a cadaver heart, a simulator (e.g., simulated with a body part, tissue, etc.), etc.

Claims

1. A device for use with a tissue anchor, the device comprising: an anchor access device including a housing shaped to define a passage having an anchor storage compartment and a proximal opening; and a retaining member disposed within the passage of the anchor access device, the retaining member: having a retaining state in which the retaining member is configured to hold the tissue anchor within the anchor storage compartment, and being configured to move in response to a proximally-directed force applied to the tissue anchor to permit the tissue anchor to exit the anchor storage compartment in response to the proximally-directed force, the proximally-directed force being greater than a predetermined threshold force, wherein the retaining member is shaped to define a bracket at its proximal end, the bracket defining a first inclined surface and a second inclined surface configured to bear against the tissue anchor such that the tissue anchor fits snugly within the anchor storage compartment.

2. The device according to claim 1, wherein the first inclined surface and the second inclined surface are adjacent to form a vertex of the bracket.

3. The device according to claim 1, wherein the first inclined surface and the second inclined surface form a generally "V" shape.

4. A device for use with a tissue anchor, the device comprising: an anchor access device including a housing shaped to define a passage having an anchor storage compartment and a proximal opening; a retaining member disposed within the passage of the anchor access device, the retaining member: having a longitudinal axis, having a retaining state in which the retaining member is configured to hold the tissue anchor within the anchor storage compartment, and being configured to permit the tissue anchor to exit the anchor storage compartment in response to a proximally-directed force applied to the tissue anchor and moving in response thereto, the proximally-directed force being greater than a predetermined threshold force; and a pivot coupled to the retaining member, the pivot including a support post that can be coupled to the tissue anchor, the pivot being configured to pivot the support post and the tissue anchor away from the longitudinal axis of the retaining member.

5. The device according to claim 4, wherein the tissue anchor is shaped to define a lumen, and wherein the support post is shaped to define a rod that fits within the lumen of the tissue anchor.

6. A device for use with a tissue anchor and an anchor driver, the device comprising: a housing shaped to define a passage that: has (i) an anchor storage compartment and (ii) a proximal opening configured to provide access for the anchor driver to the anchor storage compartment, and is configured to enable the tissue anchor to slide therein for storage within the anchor storage compartment; and a retaining member, the retaining member: is shaped to define a bracket for supporting and clamping the tissue anchor in the anchor storage partition, and includes a post that is pivotable relative to the bracket and is configured to support the tissue anchor at the bracket.

7. The apparatus according to claim 6, further comprising the tissue anchor, wherein the tissue anchor is shaped to define a core and a tissue engaging member.

8. The apparatus according to claim 7, wherein the tissue engaging member is shaped to define a lumen, and wherein the post is received within the lumen of the tissue engaging member.

9. The apparatus according to claim 7, wherein the tissue anchor is sized to slide through the channel without the tissue engaging member contacting the housing.

10. The apparatus according to claim 6, wherein the retaining member further includes a pivot that is coupled to the post and is configured to enable the post to pivot angularly away from the longitudinal axis of the retaining member.

11. The apparatus according to claim 6, wherein the post is configured to distribute the load borne by the tissue anchor supported at the bracket.

12. The apparatus according to claim 6, wherein the bracket is shaped to define a first inclined surface and a second inclined surface.

13. The apparatus according to claim 12, wherein the first inclined surface and the second inclined surface are adjacent to form a vertex of the bracket.

14. The apparatus according to claim 12, further comprising the tissue anchor, wherein: the tissue anchor is shaped to define a core and a tissue engaging member, and the first inclined surface and the second inclined surface are configured to support only the core of the tissue anchor.

15. The apparatus according to claim 12, wherein the first inclined surface and the second inclined surface are configured to abut against the tissue anchor.

16. The apparatus according to claim 6, further comprises: a gripper shaped to define a space for receiving the housing therein, the gripper including a coupler configured to reversibly couple the housing to the gripper; and a wearable item coupled to the gripper and configured to temporarily attach the apparatus to a body part of a user.

17. The apparatus according to claim 16, wherein: the body part is a body part selected from the group consisting of the user's arm, the wrist connected to the user's arm, and the hand connected to the user's arm.

18. The apparatus according to claim 16, wherein the gripper is shaped to receive the housing via a first end of the gripper and is further shaped to receive the housing via a second end of the gripper, the second end being opposite the first end.

19. The apparatus according to claim 16, wherein the wearable item includes a rigid material at least near the gripper.

20. The apparatus according to claim 16, wherein the wearable article includes a strap having a first portion terminating at a first end and a second portion terminating at a second end.

21. The apparatus according to claim 20, wherein the first end and the second end are separable by an adjustment mechanism including a spring-loaded coupler that enables the first and second portions of the strap to move away from each other.

22. The apparatus according to claim 21, wherein the spring-loaded coupler is configured to bias the first and second portions of the strap toward each other to facilitate a snug coupling of the apparatus to the body part.

23. The apparatus according to claim 6, wherein: the housing is shaped to define a chamber in fluid communication with the channel, the chamber having a longitudinal axis, and at least a portion of the retaining member is configured to slide within the chamber in response to a proximally-directed force applied to the tissue anchor.

24. The apparatus according to claim 23, wherein the retaining member includes a pin configured to slide through the chamber.

25. The apparatus according to claim 24, wherein: the housing is shaped to define a first cavity and a second cavity in fluid communication with the chamber, at least a portion of the retaining member is elastic, the pin is shaped to define a first leg and a second leg that are compressible toward each other and toward the longitudinal axis of the chamber, each of the first leg and the second leg is shaped to define a respective ratchet, and the apparatus is sized such that when the retaining member permits the tissue anchor to leave the anchor storage compartment, further proximal movement of the retaining member causes the respective ratchets of the first leg and the second leg to move into the first cavity and the second cavity, respectively.

26. The apparatus according to claim 6, further comprising the anchor driver.

27. An apparatus for use with a tissue anchor and an anchor driver, the apparatus comprising: a housing shaped to define a channel that: has (i) an anchor storage compartment and (ii) a proximal opening configured to provide access for the anchor driver to the anchor storage compartment, and is configured to enable the tissue anchor to slide therein for storage in the anchor storage compartment; and a retaining member that: is shaped to define a bracket for cradling and clamping the tissue anchor in the anchor storage compartment, has a retaining state in which the retaining member is configured to hold the tissue anchor in the anchor storage compartment, is disposed within the housing such that proximal sliding of the tissue anchor out of the anchor storage compartment and through the channel causes the retaining member to slide proximally, and includes a post configured to support the tissue anchor at the bracket.

28. The apparatus according to claim 27, wherein the post is pivotable relative to the bracket.

29. The apparatus according to claim 27, further comprising the tissue anchor stored in the anchor storage partition.

30. The apparatus according to claim 27, further comprising the anchor driver.

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