Anchor Delivery and Evaluation System

Abstract

A system and method for evaluating the fixation of one or more tissue anchors (502), the system comprising: an outer shaft having an inner lumen; and an inner shaft (505) at least partially received within the inner lumen of the outer shaft and configured to drive one or more tissue anchors, the inner shaft (505) having a substantially flexible structure (507) relative to the outer shaft.

Description

Technical Field

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 366,713, filed on June 21, 2022, entitled ANCHOR DRIVERS; U.S. Provisional Patent Application No. 63 / 415,595, filed on October 12, 2022, entitled ANCHOR DELIVERY SYSTEMS; and U.S. Provisional Patent Application No. 63 / 489,147, filed on March 8, 2023, entitled ANCHOR DELIVERY AND ASSESSMENT SYSTEMS, the entire disclosures of which are incorporated herein by reference.

Background Art

[0002] Annuloplasty generally involves remodeling of the tissue of the native heart annulus. Remodeling of the annulus can be performed by pulling the tissue around the annulus into a new shape. A tensioning wire / line that connects tissue anchors and / or other implant devices can be used to facilitate medical procedures such as annuloplasty or other remodeling procedures.

Summary of the Invention

Means for Solving the Problems

[0003] Described herein are one or more methods and / or devices for delivering, driving, and / or evaluating the placement and / or fixation of one or more tissue anchors.

[0004] Some implementations of the present disclosure are systems for evaluating the fixation of one or more tissue anchors, the system comprising an outer shaft including an inner lumen, and an inner shaft at least partially received within the inner lumen of the outer shaft and configured to drive one or more tissue anchors, the inner shaft having a substantially flexible structure relative to the outer shaft.

[0005] In some implementations, the technology described herein relates to a system where the inner shaft includes one or more cavities configured to improve the flexibility of the inner shaft.

[0006] In some implementations, the technology described herein relates to a system where the outer shaft is configured to advance and retract independently of the inner shaft.

[0007] According to some implementations of the present disclosure, a method for evaluating the fixation of one or more tissue anchors includes delivering an outer shaft and an inner shaft to a target tissue location, the outer shaft at least partially surrounding the inner shaft.

[0008] In some implementations, the method further includes attaching the inner shaft to a tissue anchor.

[0009] In some implementations, the method further includes retracting the outer shaft to expose a distal portion of the inner shaft.

[0010] In some implementations, the method further includes advancing the inner shaft to create slack in a distal portion of the inner shaft.

[0011] In some implementations, the method further includes evaluating the tissue anchor using the inner shaft attached to the tissue anchor.

[0012] In some implementations, the method further includes advancing the outer shaft to drive the tissue anchor into the tissue.

[0013] In some implementations, the inner shaft is substantially flexible relative to the outer shaft. In some implementations, the inner shaft includes one or more cavities configured to improve the flexibility of the inner shaft.

[0014] In some implementations, the outer shaft is configured to advance and retract independently of the inner shaft.

[0015] In some implementations, the method further includes removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is suitably fixed.

[0016] In some implementations, advancing the inner shaft to create a sag in the distal portion of the inner shaft involves enabling the distal portion of the inner shaft to bend in multiple directions.

[0017] In some implementations, the method further includes removing the inner shaft from the tissue anchor.

[0018] In some implementations, the method further includes attaching the inner shaft to a second tissue anchor. In some implementations, the method further includes retracting the outer shaft to expose the distal portion of the inner shaft.

[0019] In some implementations, the method further includes advancing the inner shaft to create a sag in the distal portion of the inner shaft.

[0020] In some implementations, the method further includes evaluating the second tissue anchor using the inner shaft attached to the second tissue anchor.

[0021] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part can optionally be referred to as a "simulation" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized representation and / or a physical representation.

[0022] According to some implementations of the present disclosure, a method for delivering one or more tissue anchors includes delivering an elongate shaft carrying one or more tissue anchors at a distal end of the elongate shaft to a target tissue location.

[0023] In some implementations, the elongate shaft comprises a bend configured to move between a first state and a second state.

[0024] In some implementations, the method may further include driving one or more tissue anchors into the target tissue location and moving the bend from the first state to the second state to facilitate moving the bend from the second state to the first state.

[0025] In some implementations, moving the bend from the first state to the second state may involve compressing the bend.

[0026] In some implementations, moving the bend from the first state to the second state involves twisting the elongate shaft until a gap is formed in the bend.

[0027] In some implementations, the bend comprises at least one removable tab between segments of the bend. The segments can be in a ring shape.

[0028] In some implementations, the bend may comprise an interlocking network of teeth. In some implementations, the bend comprises a coil extending through a lumen of the bend.

[0029] In some implementations, the coil is configured to interconnect segments of the bend. In some implementations, the bend may comprise a cutout through the elongate shaft.

[0030] In some implementations, moving the bend from the first state to the second state involves pulling one or more pull wires that extend at least partially through the bend.

[0031] In some implementations, the bend includes two or more segments. In some implementations, one or more pull wires interconnect the two or more segments.

[0032] In some implementations, moving the bend from the second state to the first state involves releasing one or more pull wires.

[0033] In some implementations, in response to determining that the first tissue anchor is not suitably fixed, the method further includes moving the bend from the first state to the second state to facilitate driving the first tissue anchor further into the target tissue location.

[0034] In some implementations, in response to determining that the first tissue anchor is suitably fixed, the method includes removing the bend from the first tissue anchor.

[0035] In some implementations, the method further includes moving the first tissue anchor from the first state to the second state to facilitate driving a second tissue anchor into a second target tissue location.

[0036] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part can optionally be referred to as a "simulation" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized representation and / or a physical representation.

[0037] In some embodiments, a system for delivering one or more tissue anchors comprises an elongate shaft that carries one or more tissue anchors to a target tissue location at a distal end of the elongate shaft. In some embodiments, the elongate shaft comprises a bend configured to move between a first state and a second state.

[0038] In some embodiments, the system further comprises an inner shaft configured to extend at least partially through the lumen of the elongate shaft. In some embodiments, the system may further comprise an outer shaft configured to at least partially surround the elongate shaft.

[0039] In some embodiments, the bend may be configured to move from the first state to the second state by compressing the bend.

[0040] In some embodiments, the bend is configured to form a gap in response to torsional rotation of the elongate shaft.

[0041] In some embodiments, the bend comprises at least one removable tab between segments of the bend. The segments can be in a ring shape.

[0042] In some embodiments, the bend may comprise an interlocking network of teeth. In some embodiments, the bend comprises a coil extending through the lumen of the bend.

[0043] In some embodiments, the coil is configured to interconnect segments of the bend. The bend may comprise a cutout through the elongate shaft.

[0044] In some embodiments, the system may further comprise one or more pull wires configured to extend at least partially through the bend. In some embodiments, the one or more pull wires extend at least partially through a plurality of segments of the bend.

[0045] In the present disclosure, any of the various systems, assemblies, devices, instruments, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient. The methods herein may include (or additional methods may include or consist of) sterilization of the related systems, devices, instruments, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0046] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features are described. It should be understood that not all such advantages may necessarily be achieved according to any particular implementation. Thus, the disclosed implementations may be carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0047] The methods and structures disclosed herein for treating a patient also include similar methods and structures that are implemented on or disposed on a simulated patient, which are useful, for example, for training, for demonstration, for treatment and / or device development, and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation can include simulation of all or a portion of a patient, such as, for example, the whole body, a body part (e.g., the chest), a system (e.g., the cardiovascular system), an organ (e.g., the heart), or any combination thereof. The physical elements can be natural, which may include a human or animal cadaver or a part thereof, synthetic, or any combination of natural and synthetic. The virtual elements can be entirely within silica or overlaid on one or more of the physical components. The virtual elements can be presented on any combination of a screen, headset, holographic, projection, loudspeaker, headphones, pressure transducer, temperature transducer, or presented using any combination of suitable technologies.

[0048] Various implementation forms are shown in the accompanying drawings for illustrative purposes, but should never be construed as limiting the scope of the present invention. In addition, various features of different disclosed implementation forms can be combined to form additional implementation forms that are part of the present disclosure. Throughout the drawings, reference numerals can be reused to indicate correspondences between reference elements.

Brief Description of the Drawings

[0049]

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[0050] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0051] Specific preferred implementations and examples are disclosed below, but the subject matter of the invention extends beyond the specifically disclosed implementations to other alternative implementations and / or uses, as well as modifications and equivalents thereof. Accordingly, the claims that may arise from this specification are not limited by any of the specific implementations described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be sequentially described as a plurality of distinct operations in a manner that may be useful for understanding a particular implementation, but the order of description should not be construed as implying that these operations are order-dependent. Further, the therapeutic techniques, methods, operations, steps, etc., described or suggested in this specification or in the references incorporated herein may be performed on living animals (e.g., humans, other animals, etc.) or on non-living simulations such as cadavers, cadaver hearts, simulators, virtual humans, etc. When performed in a simulation, body parts such as the heart, tissue, valves, etc., may optionally be referred to as "simulations" (e.g., simulation heart, simulation tissue, simulation valve, etc.) and may include computerized and / or physical representations of body parts, tissues, etc.

[0052] In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various implementations, specific aspects and advantages of these implementations are described. Not all such aspects or advantages are necessarily achieved by any particular implementation. Thus, for example, various implementations may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0053] Certain reference numerals are reused across different drawings throughout the disclosure of the present disclosure, from the perspective of convenience, for devices, components, systems, features, and / or modules that may have features that are similar in one or more respects. However, for any of the implementations disclosed herein, the reuse of common reference numerals in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one of ordinary skill in the art can learn from the context the degree to which the use of common reference numerals can suggest similarities between the referenced subjects. The use of a particular reference numeral in the context of the description of a particular figure can be understood as being related to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily related to any device, component, aspect, feature, module, or system identified by the same reference numeral in another figure. Further, aspects regarding separate figures identified by common reference numerals can be interpreted as either sharing features or being completely independent of each other.

[0054] Certain standard anatomical terms of location are used herein, with respect to the preferred embodiments, to refer to the anatomical structures of an animal, namely a human. Certain spatially relative terms such as "outer", "inner", "upper", "lower", "down", "up", "vertical", "horizontal", "top", "bottom", and like terms are used herein to describe the spatial relationship of one device / element, or anatomical structure, to another device / element, or anatomical structure, but it is understood that these terms are used herein for ease of explanation to describe the positional relationship between the elements / structures illustrated in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the element / structure in addition to the orientation illustrated in the drawings, during use or operation. For example, an element / structure described as "upper" than another element / structure may represent a position located below or beside such other element / structure with respect to the subject patient or an alternative orientation of the element / structure, and vice versa.

[0055] The embodiments described herein relate to devices and / or methods for identifying and / or facilitating the successful fixation of one or more tissue anchors within a patient's body. Various devices used to deliver an implant (e.g., a tissue anchor) to the heart and / or other anatomical structures may be required to strongly press against the structures within the heart and / or the implant itself. Further, the delivery path (e.g., the femoral vein) used to deliver a device and / or system to reach the heart may include, for example, a sharp trajectory to the tricuspid valve and / or the mitral valve annulus. As a result, a device (e.g., a shaft and / or catheter), particularly the distal portion of the device, may need to be flexible and / or bendable to enable delivery through such a trajectory. These devices must also be able to translate vertical pressure, tighten a cable, and / or position and / or secure an anchor delivered through the device. The implementation devices may comprise various features configured to facilitate navigation to a target location and / or actuation of one or more tissue anchors at the target location.

[0056] In some embodiments, the anchor driver comprises a bent portion and / or a shaft that is at least partially separable. The shaft may comprise two or more co-linear portions, including a distal portion and a proximal portion. In some embodiments, the distal and proximal portions may be at least partially removed and / or may be discontinuous. The anchor driver may comprise one or more connectors configured to at least partially form an attachment between the distal portion and the proximal portion. In some embodiments, the connector may comprise a wire and / or coil extending from the distal portion to the proximal portion. The one or more connectors may extend at least partially within the distal and / or proximal portions and / or may be configured to extend across a gap and / or break between the distal and proximal portions. In some embodiments, the one or more connectors may be configured to maintain contact between the distal and proximal portions via tension and / or mechanical function. The one or more connectors may be configured to allow separation between the distal and proximal portions in response to an increase in resistance in the distal and / or proximal portions. For example, separation of the distal and proximal portions may occur when sufficient torque resistance is experienced in the distal and / or proximal portions and / or when identified fluoroscopically and / or electrically.

[0057] The shaft of the anchor driver may comprise a distal portion and a proximal portion that are at least partially disconnected, which may be at least partially collinear with each other in a default and / or stationary state. A spring wire can hold the two parts together via tension, and the faces of the two parts are typically in the same plane as each other in a stationary and / or first state. The dividing line can be diagonal and / or spiral. When sufficient torque resistance is received (e.g., because the anchor head has reached the tissue and / or the anchor is complete), continued rotation of the proximal component can cause a certain degree of separation of the proximal component from the distal component. The wire and / or coil can maintain the integrity of the driver, but the resulting gap and / or offset can be detectable fluoroscopically and / or electrically. The spring constant of the spring wire and / or the characteristics of the faces of the two parts of the shaft (e.g., size, surface, angle) may be known and / or can be used to adjust the driver to divide at a specific torque resistance.

[0058] Some implementations relate to devices configured to be deformable between a flexible state and a substantially rigid state. The methods described herein provide a method for delivering a shaft in a flexible form and changing it to a substantially rigid bar and / or shaft configured to drive one or more anchors.

[0059] The shafts and / or catheters described herein can be used for delivery of an anchor configured to ride on a wire and / or line. In some implementations, the wire can be tightened when a desired number of anchors are placed to determine an appropriate point to end a procedure. Due to the flexibility of some anchor drives, it can be difficult to enable the anchor drive to apply tension to the wire (e.g., for a fixed check). The implementations described herein advantageously can resist the tension associated with tightening to enable tightening at one or more points and / or securing the anchor at points along the wire. In some implementations, the delivery system comprises a compressible drive shaft that can be compressed from a flexible state to a compressed state using a rotatable nut and / or one or more pull wires. In some implementations, the shaft can be at least partially constructed from nitinol and / or other shape memory alloys.

[0060] The present disclosure relates to anchor devices, tensioning devices, systems, and methods for fixing and / or adjusting tension in a wire or other line that can be coupled to one or more tissue anchors or other implant devices. Such implementations may involve linear / axial actuation of one or more anchors and / or tensioned lines. The term "line" is used herein according to its broad and ordinary meaning and refers to any elongated wire, tether, cord, strip, strand, suture, rope, filament, tie, string, ribbon, strap, or portion thereof, or other type / form of material used in a medical procedure to connect, fasten, secure, align, tie, hold, or otherwise control / manipulate an implant device or component (e.g., a tissue anchor). Further, implementations of the present disclosure may be implemented in relation to non-surgical and / or non-biological wire / wire tensioning. Further, in some contexts herein, the terms "tether," "wire," and "line" may be used substantially interchangeably. Further, the use of any singular form of the terms related to lines listed above, including the terms "tether" and "wire," may be used to refer to a single wire / cord, or a portion thereof.

[0061] In some implementations, the present disclosure relates to systems, devices, and methods for driving and / or securing one or more tissue anchors associated with an implant device / assembly. The term "associated with" is used herein according to its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as being "associated with" a second feature, element, component, device, or member, such description is understood to indicate that the first feature, element, component, device, or member is physically coupled to, attached to, connected to, integrated with, at least partially embedded within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0062] Certain implementations are disclosed herein in connection with a heart implant device. However, while the specific principles disclosed herein are particularly applicable to the anatomical structure of the heart, it should be understood that a tissue anchor-based implant device according to the present disclosure can be implanted within or configured to be implanted within any suitable or desired anatomical structure.

[0063] For purposes of assisting in the understanding of the specific inventive concepts disclosed herein with respect to the anatomical structure of the heart, the following is described. In humans and other vertebrates, the heart generally includes a muscular organ having four pumping chambers, the blood flow through which is at least partially controlled by various heart valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves can be configured to control the flow of blood to each region of the heart and / or blood vessels (e.g., pulmonary artery, aorta, etc.) in response to pressure gradients existing during various stages of the cardiac cycle (e.g., relaxation and contraction). The various myocardial contractions can be facilitated by signals generated by the electrical system of the heart, which is discussed in more detail below.

[0064] FIG. 1 illustrates an exemplary representation of a heart 1 and associated anatomical structures having various features related to a particular implementation of the disclosure of the present invention. Generally, the heart 1 includes four heart chambers, namely, a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. With respect to blood flow, generally, blood flows from the right ventricle 4 through a pulmonary valve (not shown for clarity) into the pulmonary artery, which separates the right ventricle 4 from the pulmonary artery and is configured to open during systole so that blood can be pumped towards the lungs and close during diastole to prevent blood from flowing back into the heart from the pulmonary artery. The pulmonary artery carries deoxygenated blood from the right side of the heart to the lungs.

[0065] In addition to the pulmonary valve, the heart 1 further includes the tricuspid valve 8, the aortic valve 7, and the mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps / tips and can generally close during ventricular contraction (i.e., systole) and open during ventricular dilation (i.e., diastole). The mitral valve 6 generally has two cusps / tips and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and when functioning properly, it is configured to close during systole to prevent blood from flowing back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood exiting the left ventricle 3 to enter the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0066] Heart valves can generally be associated with a relatively dense fibrous / collagenous ring-like structure, generally referred to herein as the annulus, and a plurality of valve cusps or leaflets attached to the annulus. Generally, the size of the valve cusps or leaflets is such that when the heart contracts, the blood pressure rise occurring inside the corresponding heart chamber causes the valve cusps to at least partially open, allowing flow from the heart chamber. When the pressure in the heart chamber decreases, the pressure in the subsequent heart chamber or blood vessel becomes dominant and can push the valve cusps back. As a result, the valve cusps / leaflets are juxtaposed to each other, thereby closing the flow path.

[0067] Regarding heart valves and related interventions (e.g., annuloplasty procedures), the mitral valve 6 is specifically mentioned herein. However, any description in this specification of the anatomical structures and / or devices or procedures associated with the mitral valve can be applied to other valves of the heart (e.g., tricuspid, aortic), and the mention of the mitral valve is for convenience only and / or should be understood to be due to its specific relevance.

[0068] Referring to the mitral valve 6, its annulus 10 attaches the mitral valve leaflets 13 and the left atrium 2 to the left ventricle 3 and the small orifice at the base of the aorta. Under normal conditions, the mitral valve 6 undergoes significant dynamic changes in shape and size throughout the cardiac cycle. These changes are mainly due to the dynamic movement of the surrounding mitral annulus 10. Throughout the cardiac cycle, the annulus 10 generally undergoes sphincter-like movements that constrict the valve orifice area during systole to facilitate leaflet coaptation and widen during diastole to allow relatively easy diastolic filling of the left ventricle 3. This movement can be further enhanced by a prominent three-dimensional configuration during systole that can embody a characteristic saddle shape. The shape and morphology of the annulus 10 throughout the cardiac cycle can affect proper leaflet coaptation and / or tissue stress. Dysfunction of the heart valve and / or related leaflets (e.g., pulmonary valve dysfunction) can result in valve leakage and / or other health complications.

[0069] The atrioventricular (i.e., mitral and tricuspid) heart valves are generally connected to a collection of chordae tendineae 11 and papillary muscles 9 that secure the leaflets of each valve to promote and / or facilitate proper apposition of the leaflets and prevent their prolapse. For example, the papillary muscles can generally include finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae 11. A wall of muscle 17 called the septum separates the left 2 and right 5 atria and the left 3 and right 4 ventricles.

[0070] Various problems can impede blood flow through the heart valves. For example, regurgitation, also known as valvular insufficiency or incompetence, occurs when the valve does not close properly, allowing blood to leak backward instead of moving in a proper one-way flow. Regurgitation can ultimately cause a decrease in the amount of blood that reaches the body's organs. To compensate for the regurgitation, the heart may work harder, which over time can lead to heart enlargement / dilation and reduced cardiac output. In some cases, ischemic heart disease can cause valvular regurgitation. For example, mitral regurgitation can be caused by a combination of ischemic dysfunction of the papillary muscle and dilation of the left ventricle seen in ischemic heart disease, followed by displacement of the papillary muscle and dilation of the mitral annulus. Valvular problems can be present at birth or caused by infections, heart attacks, or heart disease or injury.

[0071] Certain heart valve diseases / dysfunctions can be treated through the implementation of specific annuloplasty treatments, which can help the deformed annulus regain the physiological form and function of a normal, healthy valve (e.g., mitral valve) apparatus. For example, an annuloplasty treatment can involve the implantation of an artificial annuloplasty device (e.g., a ring-shaped device, or "annuloplasty ring"). An annuloplasty treatment can function to restore / remodel the annulus dimensions of the heart valve, which can facilitate proper leaflet coaptation and / or provide a larger coaptation surface. An annuloplasty procedure, including annuloplasty ring implantation, can effectively remodel the annulus to restore its size and physiological shape (e.g., D-shaped or kidney-type shape) and / or to reduce the entire circumference of the annulus.

[0072] In some cases, the annuloplasty ring / device is constructed from a core material such as silicone or metal that provides the desired rigidity, and the annuloplasty ring can be designed to be relatively flexible, semi-rigid, or rigid. Some annuloplasty rings are coated within a fabric material (e.g., dacron or polyester) through which fixation sutures can be placed. The annuloplasty ring can be formed in various sizes, rigidities, and shapes and can comprise a partial band or a complete ring. The size of the annuloplasty ring can be selected / determined based at least in part on the specific dimensions of the target heart valve / annulus (e.g., height of the anterior leaflet, commissural distance, intertrigonal distance, etc.).

[0073] The annuloplasty ring implantation procedure can be performed by accessing the heart valve through the chest wall. For example, open-heart access can be utilized to access the heart and the target valve. Alternatively, certain minimally invasive techniques in which one or more relatively small incisions in the chest are made to access the valve may be performed. A transcatheter annuloplasty intervention can be used, and the implant device / assembly is advanced through the patient's vasculature to the target annulus, which can be accessed through the femoral vein or other access site / pathway. The transcatheter annuloplasty procedure may be preferred over surgical and minimally invasive procedures due to the reduced risk to the patient, and the transcatheter annuloplasty procedure according to aspects of the present disclosure may be particularly desirable for the treatment of patients with mitral regurgitation who are considered inoperable or at high surgical risk.

[0074] The minimally invasive percutaneous implantation of the annuloplasty device according to the embodiments of the present disclosure provides a relatively safe treatment compared to conventional open heart surgery. Further, such a procedure may enable a relatively early adaptation to treatment in order to improve the opportunity for prognostic benefit. A transcatheter annuloplasty device comprising tissue anchors connected by a tensioning tether / line connector according to an embodiment of the present disclosure may provide results similar to those of a surgical annuloplasty ring, for example, with respect to the ability to reduce septal dimensions and increase leaflet coaptation. An exemplary system that may be utilized in connection with the tensioning solutions presented herein is the Cardioband Mitral Reconstruction System by Edwards Lifesciences, a percutaneous surgical-like direct annuloplasty device that may be implanted in a beating heart. Such a device may be implanted on the posterior annulus under fluoroscopy and transesophageal echocardiogram (TEE) guidance. After implantation of the tissue anchors associated with the implant device within or near the native annulus, the device may be contracted using wire / line tensioning to remodel the annulus and improve mitral regurgitation.

[0075] With further reference to FIG. 1, after implantation of one or more tissue anchors 102, at least a portion of an annuloplasty implant system that may be at least partially adjustable is shown. FIG. 2 shows a plan view of an annuloplasty implant system 200 implanted in a native heart annulus 10 according to one or more embodiments. In the image of FIG. 2, tensioning wires 210 are used to interconnect a plurality of tissue anchors 202 and / or may be tensioned and / or locked. A delivery system (e.g., including an outer catheter 101, an inner catheter 103, a channel 107, and / or a delivery shaft 105 as shown in FIG. 1) may be withdrawn.

[0076] The anchor 102 can be fixed to the native valve annulus 10 and / or other anatomical structures surrounding the valve orifice / cusp. In some embodiments, the implant system may include a sleeve (e.g., polyester) around at least a portion of the wire 210 and / or the anchor 102 / 202. Applying tension to the wire 210 can effectively shorten the implant system, thereby adjusting the size of the implant system to the patient's needs. The application of tension can be performed under imaging (e.g., echo) guidance as a means to generate and confirm the desired reduction in regurgitation.

[0077] The tissue anchor 102 / 202 can be delivered to the target anatomical structure using a delivery system, which may comprise one or more delivery and / or guide catheters and / or access sheaths, such as, for example, an outer catheter 101, an inner catheter 103, a channel 107, and / or a delivery shaft 105 and / or sheath, any of which may be operable. For mitral repair, at least a portion of the delivery system can be advanced through the atrial septum. The catheters 101, 103 can include a steerable guide catheter and a flexible tube configured to advance through the guide catheter to facilitate delivery and implantation of the tissue anchor 102 therefrom. During delivery, at least a portion of the potentially steerable distal end of such a flexible tube can be deployed from the distal end of the guide catheter to advance to the valve annulus 10 of the target valve (e.g., mitral valve 6).

[0078] The implant system may comprise a plurality of implantable tissue anchors 102 / 202, which may include metal or other biocompatible materials. In some implementations, the anchors 102 / 202 are corkscrew-type tissue anchors having a proximal drive head, which can be engaged by a drive shaft 105 to implant the anchor into the target tissue. The delivery system may include an anchor delivery shaft for advancing the anchor 102 / 202 from the distal end of the delivery system. In some implementations, the tissue anchors 102 / 202 include stainless steel anchors having a length of 5 to 10 mm (e.g., about 6 mm). The anchors 102 / 202 can be used to fix the connection wire / wire 210 to the target tissue (e.g., the valve annulus 10). Although 18 anchors 202 are shown in FIG. 2, it should be understood that any number of tissue anchors, such as any number from 12 to 20, can be implemented. The anchors 102 / 202 can be repositionable and / or retrievable prior to the complete deployment of the implant device, as shown in FIG. 2.

[0079] Certain processes / operations may be performed to deliver and fix the implant device. For example, the delivery system can advance towards the valve annulus 10. In some implementations, the outer catheter / sheath 101 can advance through the patient's vasculature to within the right atrium 5 and then through the atrial septum until its distal end is positioned within the left atrium 2. The steerable distal end portion of the outer catheter / sheath can then be steered such that the distal end portion is positioned in a desired spatial orientation within the left atrium 2. The steering procedure can be performed using imaging such as fluoroscopy, transesophageal echo, and / or cardiac echo.

[0080] Access to the right ventricle 5 can be performed using any suitable or desirable access route, such as through the femoral vein and / or through arterial access. It should be understood that any suitable origin can be used. For example, access can be performed by transseptal introduction (e.g., through the fossa ovalis) into the patient's femoral vein, within the right atrium 5, and within the left atrium 2 through the inferior vena cava 19. In some embodiments, access can be performed into the right atrium 5 through the ulnar cutaneous vein, the subclavian vein, and the superior vena cava 16. In some embodiments, access can be performed into the right atrium 5 and / or the left atrium 2 through the jugular vein, the subclavian vein, and the superior vena cava 16.

[0081] Such access can be used to advance a guidewire to a target location within the left atrium 2. A relatively stiff guidewire can be utilized for the purpose of crossing the atrial septum. The delivery system can advance over the guidewire into the left atrium 2. The inner catheter 103 can be positioned over the anterior commissure to provide a starting position suitable for deployment of the first anchor 202a. Verification of the first anchor location can be obtained using imaging. In some embodiments, the first anchor 202a is positioned near the anterior commissure, as far forward as possible within the annulus, and near the leaflet hinge.

[0082] The first anchor 202a can be delivered and implanted using an anchor delivery drive shaft 105 that can be provided inside the catheters 101, 103. The anchor 102 / 202 can be released under imaging guidance (e.g., echocardiogram, fluoroscopy) after checking for proper fixation with push-and-pull tests. After proper fixation of one anchor, the catheters 101, 103 can be navigated to the next fixation point along the valve annulus (e.g., using a proximal handle / manipulation knob of the system). Such an action can be repeated until the implant catheter tip reaches the last fixation site where the last anchor 202b is deployed. The implant device can then be disconnected from the delivery catheters 101, 103 using a tensioning wire 210 that passes from the tissue anchor 102 / 202 through the sheaths 101, 103 and the patient's anatomical structure to a location outside the body, and an adjustment tool can advance along the tensioning wire 210 to enable adjustment of the tension of the tensioning wire / line 210.

[0083] The tension adjustment tool / device can be actuated / controlled to contract the tensioning wire / line 210. For example, rotation of a knob or other actuator associated with the handle of the tension adjustment tool / device can be performed to cause tensioning of the wire / line 210. After and / or during tensioning, proper reduction of backflow or other defects in the heart valve can be evaluated using imaging (e.g., echo) under pulsatile heart conditions. When the tensioning reaches an appropriate implant size / diameter, the tensioning device / tool can be used to cut and / or lock the tension of the wire / line 210, after which the non-implant instrument can be withdrawn from the patient, leaving the implant with the desired degree of constriction.

[0084] As shown in FIG. 2, the anchor 202 can be continuously fixed around all or a part (e.g., 40 - 90%, 50 - 70%, etc.) of the valve annulus 10, and then followed by the application of tension to the wire / strand 210 to contract the valve annulus 10. In some implementations, applying tension to the wire 210 is sufficient to adequately reduce or eliminate backflow through the native valve, in which case the method / procedure can be concluded. In some implementations, if a significant amount of backflow still exists in the native valve (e.g., immediately after an initial treatment step / application of tension, or after a greater amount of time has elapsed, such as months or years later), a replacement prosthetic valve can be deployed onto the native valve annulus.

[0085] The implant device can advantageously increase leaflet coaptation and / or provide support for expansion to the posterior valve annulus. Compared to certain surgical valve annuloplasty ring devices, the annuloplasty implant shown in FIG. 2, comprising a plurality of tissue anchors 202 coupled to a common tensioned wire / strand 210, can advantageously provide improved flexibility to maintain a portion of the three-dimensional contour and its natural dynamics of the native valve annulus.

[0086] The tension of the wire / strand 210 can be locked using a locking clamp / mechanism 282 that can be coupled to the wire / strand 210 proximal to the last anchor 202b. The excess portion of the wire 210 can be cut and removed. Further, the pin 214 and / or a similar mechanism can be configured to secure the wire / strand 210 at the starting point of the wire / strand 210.

[0087] FIG. 3 illustrates an exemplary implant system 300 in which one or more tissue anchors 302 secure an annuloplasty tube 330 to the annuloplasty tissue 10 of the mitral valve 3, according to one or more implementations. The annuloplasty tube 330 can be additionally secured using one or more pins, including a first pin 344 at or near the first tissue anchor 302a and / or a second pin 342 at or near the last tissue anchor 302b.

[0088] FIG. 4 illustrates an exemplary tissue anchor 402 according to one or more implementations. The tissue anchor 402 can be a component of a tissue conditioning system and can be used to condition the dimensions of a tissue structure. For example, the tissue conditioning system can be an annulus formation system, and / or the tissue anchor 402 can be used to secure an annulus formation structure (e.g., an annulus formation ring, an annulus formation implant, etc.).

[0089] The anchor 402 can include a tissue engagement element 430 and / or a head 480 portion. The tissue engagement element 430 can be configured in various ways. In some implementations, the tissue engagement element 430 can have a proximal end 432 and / or a distal end 434 and / or can define a central longitudinal axis A of the anchor 402. At the distal end 434, the tissue engagement element 430 can have a sharp distal tip 438 and / or the tissue engagement element 430 can be configured to be driven (e.g., screwed, pushed, etc.) into the target tissue. In some implementations, as shown, the tissue engagement element 430 can be helical and / or can define a central lumen 436 along the axis A. Optionally, the tissue engagement element 430 can be another type of tissue engagement element 430, such as a dart or staple. In some implementations, the tissue engagement element 430 can be in a hook shape, straight, angled, and / or another configuration. In some implementations, the tissue engagement element 430 can include barbs or barbed portions that hold the tissue engagement element in the tissue.

[0090] The tissue engaging element 430 may have any suitable width. For an implementation where the tissue engaging element 430 is helical (e.g., as shown in FIG. 4), the width may be the outer diameter of the helix. The head 480 of the anchor 402 may be connected to the proximal end 432 of the tissue engaging element 430 and / or may include an eyelet 440 that defines a driver interface 482 and / or an aperture 446 therethrough. The driver interface 482 may be configured to be reversibly engaged by an anchor driver (see, e.g., FIG. 5). In some implementations, the anchor driver may include an elongated and / or flexible shaft and / or a driver head connected to the distal end of the shaft. The driver head may be a component of the anchor driver that reversibly engages the driver interface 482. The driver interface 482 can be firmly connected to the tissue engaging element 430.

[0091] In some implementations, as shown, the driver interface 482 may be disposed on the central longitudinal axis A and the eyelet 440 may be disposed laterally from the axis A.

[0092] In some implementations, the anchor 402 (e.g., its connector or eyelet 440) may be configured to facilitate sliding of the anchor 402 along the wire (or sliding of the wire through the anchor 402) while the anchor 402 is aligned with the wire (e.g., while the axis A is parallel to the wire). The anchor 402 (e.g., its connector or eyelet 440) is configured to facilitate sliding of the anchor 402 along the wire (or sliding of the wire through the anchor 402) while the anchor 402 is oriented orthogonally to the wire (i.e., while the axis A is orthogonal to the wire). This can be achieved at least in part due to the shape and dimensions of the connector or eyelet 440.

[0093] The eyelet 440 may define an opening 446 on an opening plane and / or may be mounted such that the opening plane is inclined at a fixed angle (e.g., about 30 to 60 degrees, such as 45 degrees from axis A).

[0094] In some implementations, the eyelet 440 is shaped to define (i) a first transparent straight path passing through the opening 446 along a first line parallel to axis A and (ii) a second transparent straight path passing through the opening 446 along a second line orthogonal to the first line. This shape may advantageously allow the eyelet 440 to slide along the wire in either of these mutually orthogonal orientations. If the shape of the eyelet 440 is in an orientation intermediate between these mutually orthogonal orientations, its slide along the wire may be similarly facilitated.

[0095] Regardless of the actual shape of the opening 446 described above, the eyelet 440 may be shaped and dimensioned such that the opening 446 appears circular both (i) when viewed along a first line (i.e., the first line of sight) parallel to axis A and (ii) when viewed along a second line (i.e., the second line of sight) orthogonal to the first line of sight. This shape may advantageously allow a smooth slide of the eyelet 440 along the wire in either of these orientations (and typically also in the continuum of orientations therebetween). Thus, these lines of sight may be considered the first and second slide axes of the anchor 402 (e.g., of its eyelet 440). This shape may advantageously allow such a slide even when the wire is larger than 50% (e.g., more than 70%, e.g., more than 90%) of the diameter of the apparent circular shape of the opening 446.

[0096] To further facilitate the smooth sliding of the wire through the opening 446, the eyelet 440 defines a chamfered rim around the opening. In some implementations, as shown, the chamfer may be larger on the major axis than on the minor axis (i.e., the sides of the opening 446). In some implementations, on each face of the eyelet 440 (i.e., each side of the opening 446), the eyelet 440 defines a bathtub-shaped cavity having a bottom of a bathtub that mates to form the opening 446.

[0097] In some implementations, as shown, the eyelet 440 is rotatably or pivotably mounted about the axis A, while the opening plane remains tilted at its fixed angle with respect to the central longitudinal axis. Optionally, the eyelet 440 may be rotatable and / or pivotable about another axis. For example, the head 480 may include a ring 484 to which the eyelet 440 is mounted. The ring 484 may surround the axis A and / or be rotatable about the axis A (e.g., by being rotatably coupled to another component of the head 480, such as a driver interface 482 that is fixedly coupled to the tissue engagement element, by being rotatably coupled to the tissue engagement element).

[0098] In some implementations where the tissue engagement element 430 is helical, on the side of the anchor 402 where the eyelet 440 is disposed, the helix of the tissue engagement element 430 is tilted in the same direction as the opening plane with respect to the axis A. However, the lead angle of the helix of the tissue engagement element 430 may be different from the angle of the opening plane.

[0099] As described above, the anchor 402 (e.g., its eyelet 440) can be configured to facilitate sliding of the anchor 402 along the wire (or sliding of the wire through the anchor 402) while the anchor 402 is aligned with the wire (e.g., while axis A is parallel to the wire). This can facilitate advancement of the trans-catheter of the anchor 402 along the wire. Also, as described above, the anchor 402 (e.g., its eyelet 440) is configured to facilitate sliding of the anchor 402 along the wire (or sliding of the wire through the anchor) while the anchor 402 is oriented orthogonally to the wire (i.e., while axis A is orthogonal to the wire). This can be useful in implementations where the wire is tensioned after implantation to adjust anatomical dimensions such as valve annuloplasty.

[0100] FIG. 5 illustrates an exemplary system (e.g., a delivery system, an anchor delivery system, an implant delivery system, etc.) for delivering one or more tissue anchors 502 to a target tissue site according to one or more implementations. The delivery system can include an elongate shaft 505 that can include one or more bend portions 507 having any of the various features described herein with respect to the bend portions. The elongate shaft 505 can extend between a drive handle 518 at the proximal side and / or end of the shaft 505 and a driver 520 at the distal side and / or end of the shaft 505. The driver 520 can be configured to interface with the head 580 portion of the tissue anchor 502 and / or a drive interface. For example, the driver 520 can include a generally rectangular protrusion configured to mate with a similarly rectangular interface of the tissue anchor 502.

[0101] The drive handle 518 can be coupled to a torque limiter 516 configured to prevent and / or arrest over-torque rotation of the elongate shaft 505. For example, the torque limiter 516 and / or the drive handle 518 can be torsionally rotated to cause torsional and / or torque rotation of the elongate shaft 505 and / or the tissue anchor 502. The torque limiter 516 can be configured to prevent and / or arrest torsional rotation of the shaft above a threshold torque amount.

[0102] In some implementations, the torque limiter 516 can comprise various components that can include dimples, ball bearings, and / or washers pressed against the ball bearings. The torque limiter 516 can be calibrated with screws and / or similar mechanisms. When the torque limiter rotates, the ball bearings can be configured to disengage when the torque exceeds a predetermined amount and / or can rotate freely so as not to engage the anchor drive.

[0103] The elongate shaft 505 can be the inner shaft of the delivery system and / or can be configured to pass at least partially through the outer shaft. For example, at least a portion of the elongate shaft 505 can be configured to extend through a catheter and / or other outer shaft during delivery to a patient. The outer shaft can be configured to at least partially surround the elongate shaft 505.

[0104] As shown in FIG. 5, the bend portion 507 can be located at or near the distal end of the elongate shaft 505. For example, the bend portion 507 can be closer to the driver 520 than the handle 518. However, the bend portion 507 can be located at any position along the elongate shaft 505.

[0105] In some implementations, the bending portion 507 can be an extension of the elongated shaft 505. For example, the bending portion 507 can represent a portion of the elongated shaft 505 that includes one or more features configured to facilitate a change in state of the elongated shaft 505 and / or the bending portion 507. In some implementations, the bending portion 507 can include a cutout that passes through at least a portion of the elongated shaft 505 and / or can include one or more components (e.g., springs, coils, and / or wires) configured to interconnect separate and / or disconnected portions of the elongated shaft 505. The bending portion 507 can include one or more features configured to cause a change in state of the elongated shaft 505 in response to the tissue anchor 502 being fully embedded within the tissue and / or in response to torsional and / or torque rotation of the elongated shaft 505 that meets and / or exceeds a threshold amount of force. In some implementations, the bending portion 507 can be configured to have a first state during delivery and / or to assume a second state during actuation and / or delivery of the tissue anchor 502 (e.g., when the tissue anchor 502 is fully driven into the tissue and additional torsional rotational force is applied). For example, when the tissue anchor 502 is fully embedded within the tissue while the driver 520 is engaged with the head 580, additional torsional rotational force in the elongated shaft 505 and / or the handle 518 can move the bending portion 507 and / or the elongated shaft 505 from a first state (e.g., a substantially straight state) to a second state (e.g., a bent state).

[0106] The bend portion 507 may comprise one or more features configured to facilitate the delivery and / or actuation of the elongate shaft 505 and / or the tissue anchor 502. For example, the bend portion 507 may be configured to have a substantially flexible state during delivery and / or to assume a substantially rigid state prior to actuation of the tissue anchor 502 into the target tissue site. In some implementations, one or more pull wires may extend at least partially through the elongate shaft 505 and / or the bend portion 507 (e.g., through an opening in the wall of the elongate shaft 505 and / or the bend portion 507) to facilitate movement of the bend portion 507 and / or the elongate shaft from a first state to a second state and / or vice versa.

[0107] The bend portion 507 is shown in FIG. 5 as part of an elongate shaft 505 configured to drive one or more tissue anchors 502, but the bend portion 507 can be a component of other shafts. For example, an outer shaft configured to receive and / or facilitate the delivery of the elongate shaft 505 may include one or more bend portions 507 at various locations.

[0108] FIG. 6 illustrates a system 600 (e.g., an anchor delivery system, an implant delivery system, etc.) for delivering one or more tissue anchors 602 into tissue 10 according to one or more implementations. The system 600 may include a catheter 601 (e.g., an elongate shaft and / or an outer shaft) and / or a shaft 605 (e.g., an elongate shaft and / or an inner shaft) configured to extend through the catheter 601. The shaft 605 may include an anchor driver 612. The system 600 may be configured for the delivery of one or more tissue anchors 602 and / or a tether 610 (e.g., a wire and / or a cord) through which the tissue anchor 602 is screwed (e.g., through one or more eyelets 640 of the tissue anchor 602). As will be described in more detail below, only the distal portion of the tether 610 may remain embedded in the subject during implantation, while the proximal portion of the tether remains attached to the delivery system 600.

[0109] The tissue anchors 602 are disposed continuously along the tether 610, and the delivery system 600 embeds one or more tissue anchors 602 with an anchor driver 612 that is used continuously for each of the anchors 602, advances the anchors 602 distally into the subject, and can be used to secure the anchors 602 to the internal tissue of the subject. For example, as shown, one or more tissue anchors 602 and / or the tether 610 may comprise an annuloplasty implant implanted by placing the anchors 602 around at least a portion of the annulus of a native heart valve of the subject, such as the mitral valve or tricuspid valve. Further, in some implementations, the distal end of the tether 610 advances distally into the subject with the first anchor, and subsequent anchors 602 can be advanced by sliding them distally along the tether 610. In some implementations, the system 600 and / or the techniques described for use therewith are used in combination with one or more systems and / or techniques described in U.S. Provisional Patent Application No. 62 / 949,392, filed December 17, 2019, by Kasher et al., entitled "ANNULOPLASTY AND TISSUE ANCHOR TECHNOLOGIES", which is incorporated herein by reference.

[0110] The catheter 601 can be configured to advance into the subject. In some implementations where the implant is an annuloplasty implant, as shown, the catheter 601 can be a trans-lumenally (e.g., transfemorally) advanceable catheter. The catheter 601 can extend from an extracorporeal unit (e.g., an extracorporeal unit) configured to remain outside the body of the subject. In some implementations, the extracorporeal unit defines or is coupled to a handle of the device. The tissue anchors 602 can comprise various features (e.g., head 680 portion) that enable the tissue anchors 602 to interface with and / or attach to the driver 612 of the shaft 605.

[0111] The extracorporeal unit may comprise a tensioner having a winch that facilitates reducing the sag of the tether 610 during sliding of the distal anchor 602 along the tether 610. Reducing the sag can advantageously reduce the likelihood that the tether 610 will twist or become entangled, or the likelihood of an unintentional engagement of the tether 610 with the anchor 602 during delivery. Using a winch to reduce the sag can more advantageously provide better control over the magnitude and consistency of the tension applied to the tether 610, and can more advantageously reduce the number of human operators required, compared to a human operator manually pulling on the proximal end of the tether 610.

[0112] FIG. 7 illustrates the fixation of one or more tissue anchors to tissue 10 according to one or more implementations. In FIG. 7, at least the rightmost anchor is already properly fixed, and the leftmost anchor is not yet properly fixed. Thus, the behavior of the anchors (including movement of the protrusion relative to the head 780) can be understood from these figures by comparing the left anchor to the other anchors.

[0113] In some implementations, the catheter 701 and / or a similar device may be configured to deliver the shaft 705 and / or one or more anchors 702 through the lumen of the catheter 701. The tether 710 may be configured to interconnect the various tissue anchors 702 and / or pass through one or more eyelets that may extend from the head 780 portion of the tissue anchor 702. The driver 712 of the shaft 705 may be configured to interface with the head 780 portion to carry and / or drive the tissue anchor 702. The shaft 705 may be configured to drive the tissue engagement element 730 of the anchor 702 into the tissue until the proximal end 734 and / or washer 732 of the tissue engagement element 730, or a similar mechanism of the anchor 702 between the tissue engagement element 730 and the head 780, reaches the tissue 10. The catheter 701 and / or the shaft 705 can be part / components of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0114] Figure 8 illustrates the delivery of one or more tissue anchors 802 into tissue 10 according to one or more implementations. A delivery system (e.g., an anchor delivery system, etc.) can include, among other things, a channel 807 through which an outer catheter 801, an inner catheter 803, and / or a drive shaft 805 can pass. In some implementations, one or more tissue anchors 802 can be configured to at least partially anchor through an elongated sleeve 826. A portion of the sidewall of the sleeve 826 aligns with the tissue 10 in a manner such that the surface of the portion of the sidewall is disposed parallel to the plane of the tissue 10. Further, the distal end of the channel 807 extending around the shaft 805 can be configured such that the channel 807 flattens a portion of the sidewall against the tissue 10 of the valve annulus in a manner that the channel 807 sandwiches a portion of the sidewall between the distal end of the implant-separation channel and a portion of the tissue 10 of the valve annulus in the plane in which the tissue anchor 802 is implanted. In such a manner, the portion of the sidewall to be fixed is placed flat (parallel to its plane) against the tissue 10 of the valve annulus, while the remaining portion of the tubular sidewall is disposed substantially perpendicular to a portion of the tissue into which the tissue anchor 802 is implanted.

[0115] In some implementations, different tissue anchors 802 can be deployed through different portions and / or sides of the sleeve 826. For example, a first tissue anchor 802 can be deployed through an end wall of the sleeve 826, and / or a second tissue anchor can be deployed through a sidewall of the sleeve 826. However, multiple tissue anchors 802 can extend within a substantially common direction and / or within a substantially flat surface of the valve annulus. In some implementations, the tissue anchors 802 can be disposed relative to each other at an angle of 0 to 45 degrees, such as 0 to 30 degrees, such as 0 to 20 degrees.

[0116] In some embodiments, the maximum distance between the fixed points of the first tissue anchor 802 and the second tissue anchor 802 can be provided by the length of the sleeve 826 that is disconnected from a portion of the channel 807 (e.g., the channel 807 retreats from the sleeve 826 by a distance of, for example, 3 to 15 mm, for example, 8 mm). That is, in some embodiments, the second tissue anchor 802 can be placed anywhere within a circle centered on the first tissue anchor 802 and having a radius equal to the distance between the first anchor 802 and the second anchor 802. In some embodiments, the sleeve 826 can function as a restraint member (e.g., a tether) that can be used to facilitate positioning of the second tissue anchor 802. The distance between the tissue anchors 802 can be set by the surgeon who retreats the channel 807 from the sleeve 826 by a specific distance.

[0117] FIG. 9 illustrates the delivery of the delivery shaft 905 into a chamber of the heart (e.g., the right atrium 5) according to one or more embodiments. For example, the delivery shaft 905 can be delivered upward into the right atrium 5 via the inferior vena cava 29. In some embodiments, one or more delivery shafts 905 can be configured for delivery via other routes, including via the superior vena cava into the right atrium 5. Delivery via the inferior vena cava 29 is shown for illustrative purposes, and the devices and / or methods described herein can be applicable to other delivery procedures and / or other anatomical structures. The delivery shaft 905 can be a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0118] The position of the tricuspid valve 6 relative to the inferior vena cava 29 and / or the superior vena cava may require the delivery shaft 905 to be curved as it is delivered through the inferior vena cava 29 and / or the superior vena cava. For example, the opening of the inferior vena cava 29 into the right vena cava 5 may be in a relatively common plane and / or may be adjacent to the tricuspid valve 6 along the lower portion of the right vena cava 5. When the delivery shaft 905 exits the inferior vena cava 29 and enters the right vena cava 5, the delivery shaft 905 may be oriented towards the upper area of the right vena cava 5. To reach the tricuspid valve 6, the delivery shaft 905 may need to be bent substantially into a U-shape to reorient the distal end of the delivery shaft 905 to the tricuspid valve 6, as shown by the target orientation 914 in FIG. 9. When the delivery shaft 905 is delivered through the superior vena cava, the delivery shaft 905 may similarly need to be bent to reach the tricuspid valve 6. Thus, the delivery shaft 905 may advantageously be at least partially flexible to enable access to the tricuspid valve 6 through the inferior vena cava 29 and / or the superior vena cava and / or to enable access to other anatomical structures through other pathways.

[0119] The delivery shaft 905 may be configured for the delivery of one or more anchors 902 that may be configured to pass through the lumen of the delivery shaft 905 and / or extend from the distal end of the delivery shaft 905. The delivery shaft 905 may be configured to bend to position one or more anchors 902 at the distal end of the delivery shaft 905 against and / or around the tricuspid valve 6 and / or another valve.

[0120] FIG. 10 illustrates an exemplary flexible delivery shaft 1005 configured for delivery of one or more anchors 1002 in various portions of an anatomical structure that may include the tricuspid valve 6, the mitral valve, and / or another valve, or around it. FIG. 10 illustrates a delivery shaft 1005 in one implementation that includes a flexure portion and / or a flexure portion for exemplary purposes that includes tabs 1017 interconnecting segments 1018 of the delivery shaft 1005. While other implementations described herein may be used to enable improved flexibility while delivering one or more anchors 1002 to a target anatomical structure. The delivery shaft 1005 may be a part / component of a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0121] In some implementations, the delivery shaft 1005 may comprise a plurality of parts and / or segments 1018, which may comprise one or more flexure portions and / or one or more non-flexure portions. A flexure portion may include any portion configured to provide improved flexibility of the delivery shaft 1005 and / or configured to facilitate a change in state of the shaft 1005. For example, a flexure portion may include a portion of the delivery shaft comprising one or more tabs 1017 and / or segments 1018 as shown in FIG. 10. In some implementations, the delivery shaft 1005 may comprise at least one flexure portion at and / or near the distal end and / or distal portion of the delivery shaft 1005. For example, the flexure portion may be configured to enable flexure of the distal portion of the delivery shaft 1005 to enable one or more anchors 1002 to be deployed from the tip portion at the target location.

[0122] The bendable portion may be configured to selectively provide improved flexibility and / or rigidity. In some implementations, the bendable portion may transition, transform, and / or change from a first state that provides improved flexibility to a second state that provides improved rigidity, and / or from a second state that provides improved rigidity to a first state that provides improved flexibility. For example, the bendable portion may be configured to provide improved flexibility during delivery to a target location, and / or may be changed and / or moved to provide improved rigidity during insertion of one or more anchors 1002 into a target tissue location (e.g., tissue around a valve). Further, the bendable portion may be configured to transition / change to provide improved flexibility to facilitate removal of the delivery shaft from the body.

[0123] In some implementations, one or more bendable portions may be modifiable by a surgeon and / or otherwise during a procedure. For example, a surgeon may use one or more pull wires and / or similar devices (e.g., knobs, buttons, or otherwise actuating controls to apply tension to a pull wire) to cause a transformation of the bendable portion from one state (e.g., a flexible and / or rigid state) to another state (e.g., a rigid and / or flexible state). In the flexible and / or rigid state, the shaft 1005 and / or the bendable portion may be configured to bend in a “U” shape as shown in FIG. 10.

[0124] FIG. 11 illustrates an exemplary assembly 1100 for driving one or more anchors into a target tissue according to one or more implementations. The assembly 1100 may comprise a catheter and / or an outer shaft (see FIGS. 12 and 13), and / or may be configured to be used alone or in combination with other assemblies. The assembly 1100 may be configured as an anchor delivery system, or may be a part of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0125] In some implementations, assembly 1100 may comprise a plurality of discrete and / or interconnected segments. At the distal end of assembly 1100, assembly 1100 may comprise a gripper 1112 configured to grip and / or otherwise engage onto one or more tissue anchors. For example, gripper 1112 may be configured to fit within a notch and / or opening of a tissue anchor head and / or may be configured to at least partially fit around a tissue anchor. In some implementations, assembly 1100 may comprise a groove cut around gripper 1112 and / or may be configured to mate with a protrusion of another catheter and / or assembly.

[0126] Assembly 1100 can be at least partially flexible to facilitate delivery of the assembly 1100 through one or more pathways through the body and / or target tissue site. In some implementations, assembly 1100 can have a flexibility that varies along the length of the assembly 1100. For example, assembly 1100 can include a substantially flexible segment 1101 at or near the distal end of the assembly 1100, a substantially rigid segment 1103 at or near the proximal end of the assembly 1100, and / or a semi-flexible segment 1102 between the substantially flexible segment 1101 and the substantially rigid segment 1103. In some implementations, the substantially flexible segment 1101, the semi-flexible segment 1102, and / or the substantially rigid segment 1103 can be longitudinally aligned and / or can form a shaft that extends between the handle 1118 and the gripper 1112 of the device. The flexible segment 1101 can have a width and / or diameter that is smaller than the semi-flexible segment 1102 and / or the substantially rigid segment 1103, as shown in FIG. 11. However, the flexible segment 1101 can optionally have a width and / or diameter that is substantially equivalent to the semi-flexible segment 1102 and / or the substantially rigid segment 1103. The flexible segment 1101 can be at least somewhat more flexible than the semi-flexible segment 1102 and / or the substantially rigid segment. In some implementations, the increased flexibility of the flexible segment 1101 and / or the semi-flexible segment 1102 relative to the substantially rigid segment 1103 can result from being at least partially composed of different materials and / or having a smaller width, diameter, and / or wall thickness.

[0127] In some implementations, the assembly 1100 may further include a threaded segment 1104 that is at least partially located between the substantially rigid segment 1103 and the handle 1118. The flexible segment 1101, the semi-flexible segment 1102, the rigid segment 1103, and / or the threaded segment 1104 may be configured to at least partially fit within an outer catheter (e.g., the assembly 1200 of FIG. 12). Thus, the various segments of the assembly 1100 may generally be thin so as to enable the segments to fit within the outer catheter.

[0128] In some implementations, the assembly 1100 and / or the shaft of the assembly 1100 may generally be compressible. However, the assembly 1100 may have a degree of flexibility. For example, the flexible segment 1101 may have a bending radius of about 10 mm, the semi-flexible segment 1102 may have a bending radius of about 25 mm, and / or the rigid segment 1103 may have a relatively high bending radius. The flexible segment 1101 may have a length of about 120 mm, the semi-flexible segment 1102 may have a length of about 988 mm, and / or the rigid segment 1103 may have a length of about 620 mm.

[0129] The shaft of the assembly 1100 may have an inner diameter of about 0.5 mm or more. The outer diameter may be small enough to fit within the lumen of the shaft of an outer assembly (e.g., the assembly 1200 illustrated in FIG. 12). The shaft may have a default straight and / or linear configuration.

[0130] In some embodiments, the assembly 1100 may comprise one or more flexure portions. For example, the flexible segment 1101 may comprise a cut-off portion that separates the flexible segment 1101 into disconnected portions, and / or may comprise one or more coils and / or wires configured to interconnect the disconnected portions. The flexure portion may be configured to flex, and / or the disconnected portions of the flexure portion may be configured to be offset in response to torsional rotation of the handle 1118 and / or various shafts of the assembly 1100.

[0131] FIG. 12 illustrates at least a portion of an assembly 1200 for delivering and / or driving one or more tissue anchors to a target tissue location according to one or more embodiments. In some embodiments, the assembly 1200 may be configured for use with one or more other devices. For example, the assembly 1200 may be configured for use as an outer catheter / sheath and / or may be configured to receive an inner catheter / shaft and / or an assembly (e.g., various segments of the assembly 1100 of FIG. 11). The assembly 1200 may be configured as an anchor delivery system or may be a part of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0132] In some embodiments, the assembly 1200 may comprise a plurality of distinct and / or interconnected segments and / or portions, which may include a flexure portion 1210, a substantially flexible segment 1211, a semi-flexible segment 1212, and / or a substantially rigid segment 1213. The flexure portion 1210 may be at least partially compressible from an extended configuration (e.g., during delivery) to a compressed configuration (e.g., after delivery and / or during driving one or more tissue anchors into tissue).

[0133] Assembly 1200 may include one or more controls or control features, which may include a knob 1215, buttons, switches, sliders, and / or similar mechanisms. For example, the knob 1215 may be located at the proximal end of the assembly 1200. In some implementations, the knob 1215 may be configured to control compression, expansion, and / or other transformations of the flexure portion 1210. For example, when the knob 1215 rotates in a first direction (e.g., counterclockwise), the flexure portion 1210 may be compressed to become more rigid. Similarly, when the knob 1215 rotates in a second direction (e.g., clockwise), the flexure portion 1210 may be decompressed and / or become more flexible. By compressing, the flexure portion 1210 may be configured to resist the compressive load applied when the wire passing through the assembly 1200 is placed under tension.

[0134] In some implementations, the assembly 1200 may be configured to mate with various features and / or devices. For example, the assembly 1200 may include one or more protrusions (e.g., at the distal end of the assembly 1200) configured to mate with corresponding grooves of the assembly 1100 of FIG. 11. In this way, the assembly 1200 and / or other assemblies and / or catheters may be held together to prevent and / or inhibit relative displacement between them.

[0135] The various segments of the assembly 1200 may form a tubular shaft configured to receive and / or convey one or more wires and / or tissue anchors. In some implementations, the various segments may have various flexibilities to facilitate delivery of the assembly 1200 through various anatomical paths. The various segments of the assembly 1200 may be at least partially composed of different materials and / or may include at least partially different wall thicknesses and / or lumen widths and / or diameters relative to each other.

[0136] The flexure portion 1210 can be at least partially compressible, and / or other portions of the shaft of the assembly 1200 can generally be non-compressible. In some implementations, the flexure portion 1210 can have a length of about 30 mm, and / or the substantially flexible segment 1211 can have a length of about 90 mm. The semi-flexible segment 1212 can have a length of about 988 mm, and / or the rigid segment 1213 can have a length of about 620 mm. In some implementations, the flexure portion 1210 and / or the substantially flexible segment 1211 can be configured to fit within the substantially flexible segment 1101 of the assembly 1100 of FIG. 11. The semi-flexible segment 1212 can be configured to at least partially fit within the semi-flexible segment 1102 of the assembly 1100 of FIG. 11. The rigid segment 1213 can be configured to at least partially fit within the rigid segment 1103 and / or the braided segment 1104 of the assembly 1100 of FIG. 11.

[0137] In some implementations, the shaft of the assembly 1200 can have an outer diameter large enough to fit the outer diameter of the shaft of the assembly 1100 of FIG. 11 within the lumen of the assembly 1200. The shaft of the assembly 1200 can have an outer diameter of about 2.41 mm or less.

[0138] FIG. 13 illustrates an exemplary assembly 1300 configured for delivery and / or actuation of various tissue anchors to a target tissue location according to one or more implementations. In some implementations, assembly 1300 may comprise an inner catheter and / or assembly (e.g., assembly 1100 of FIG. 11), and / or an outer catheter and / or assembly (e.g., assembly 1200 of FIG. 12). The outer assembly may comprise a shaft 1317 configured to at least partially receive and / or extend along a corresponding shaft of the inner assembly. Assembly 1300 may comprise a flexure portion 1310 configured to facilitate a change in state of the outer assembly and / or the inner assembly. For example, flexure portion 1310 may be located at a distal portion of shaft 1317 and / or may be configured to transition or change from a flexible state to a rigid state. In some implementations, assembly 1300 may comprise a knob 1315 and / or a similar mechanism configured to selectively control the transition of flexure portion 1310 from a first state (e.g., a flexible state) to a second state (e.g., a rigid state), and / or vice versa. Assembly 1300 may be configured as an anchor delivery system or may be a part of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0139] Assembly 1300 may comprise a handle 1318 and / or a similar device configured for handling by a surgeon for controlled delivery of shaft 1317 and / or other portions of assembly 1300 into and / or through the human body. In some implementations, knob 1315 and / or other control mechanisms may be located on or near handle 1318.

[0140] The flexure portion 1310 may comprise any suitable state change feature described herein. For example, the assembly 1300 may comprise one or more pull wires extending at least partially through the flexure portion 1310 to control and / or facilitate a state change of the flexure portion 1310. The one or more pull wires may be at least partially controlled using the handle 1318 and / or the knob 1315. The flexure portion 1310 is illustrated as comprising a series of interlocking plates 1328 and / or teeth, while on the other hand, the flexure portion 1310 may comprise alternative and / or additional features. For example, the flexure portion 1310 may comprise one or more springs and / or networks of wires.

[0141] Figures 14A - 14C illustrate an exemplary flexure portion 1400 of one or more shafts of a tissue anchor delivery assembly according to one or more implementations described herein. In some implementations, the delivery assembly can comprise a shaft having a generally tubular form and / or comprising an inner lumen. The inner lumen can be configured to receive and / or facilitate the conveyance of one or more wires, a delivery system, and / or a medical implant (e.g., a tissue anchor). The flexure portion 1400 can similarly have a generally tubular form and / or comprise an inner lumen. The flexure portion 1400 can be a part / component of a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0142] The flexure portion 1400 may comprise a network of one or more rings 1418 interconnected by one or more tabs 1417. The one or more tabs 1417 may be configured to extend between multiple rings 1418 of the flexure portion 1400. In some implementations, the rings 1418 may have a circular and / or cylindrical form. The one or more tabs 1417 may have any suitable form including a rectangular shape. The flexure portion 1400 may comprise any number of tabs 1417, and / or any number of tabs 1417 may be used to bridge two rings 1418 of the flexure portion 1400. For example, the flexure portion 1400 may comprise two tabs 1417 or four tabs 1417 between each pair of rings 1418.

[0143] In some implementations, the flexure portion 1400 may comprise a pair of tabs 1417 that are positioned substantially transverse to each other across the lumen of the flexure portion 1400. For example, as shown in FIG. 14A, a set 1417 of tabs is shown where a first tab 1417a may be positioned substantially transverse from a second tab 1417b. The flexure portion 1400 may comprise multiple pairs 1417 of tabs that bridge two rings 1418. For example, as shown in FIG. 14B, a set 1417 of tabs is shown and the flexure portion may comprise a first tab 1417a substantially transverse from a second tab 1417b and / or a third tab 1417c substantially transverse from a fourth tab 1417d.

[0144] The flexure portion 1400 may have any suitable length L. In some implementations, the flexure portion 1400 may comprise any number of rings 1418 and / or tabs 1417 that extend along the length of the flexure portion 1400. The flexure portion 1400 is shown as comprising six rings 1418 and / or five sets of tabs 1417, but the flexure portion may comprise any number of rings 1418 and / or sets of tabs 1417.

[0145] In some implementations, the flexure portion 1400 can be controllably moved between an extended and / or flexible state (e.g., as shown in FIGS. 14A and 14B) and a crushed and / or rigid state (e.g., as shown in FIG. 4C). In the extended and / or flexible state, one or more tabs 1417 can be configured to be attached to the ring 1418 on both sides of the tab 1417 (e.g., the first side surface 1427 and the second side surface 1428 of the tab 1417). One or more tabs 1417 can be configured to be at least partially removed from at least one of the rings 1418. For example, as shown in FIG. 14C, the first side surface 1427 of the tab 1417 can be disconnected from any of the rings 1418, while the second side surface 1428 of the tab 1417 remains connected to one or more rings 1418. Thus, the tab 1417 can extend substantially perpendicular to the length L of the flexure portion 1400 and / or can extend from any side and / or multiple sides of the flexure portion 1400. As shown in FIG. 14C, when the tab 1417 is at least partially removed from the ring 1418, the ring 1418 can be configured to close the distance previously filled by the tab 1417 and / or can be configured to move closer together and / or couple together. When the rings 1418 are coupled together and / or are positioned close to each other, the flexure portion 1400 can have a more rigid structure. In some implementations, one or more pull wires can be used to pull on one or more distal rings 1418 to move the one or more rings 1418 together.

[0146] Tab 1417 can be connected to ring 1418 in any suitable manner. For example, at least one side of tab 1417 can form a releasable and / or removable connection to ring 1418. The releasable and / or removable connection can be formed by protrusions (e.g., pegs, hooks, buttons, and / or latches) extending from tab 1417 and / or ring 1418 configured to mate with openings, notches, hooks, and / or other features in ring 1418 and / or tab 1417. In some implementations, a pull wire and / or other device can be used to facilitate removal of tab 1417 from ring 1418. In some implementations, one or more tabs 1417 can form a removable connection to a first ring 1418 and / or a secure connection to a second ring 1418. For example, as shown in FIG. 14C, one or more tabs 1417 can remain coupled to one or more rings 1418 on a second side 1428 while being removed from one or more rings 1418 on a first side 1427.

[0147] FIG. 15 illustrates an exemplary flexure portion 1500 comprising one or more rings 1518 and / or one or more springs 1550 joining the one or more rings 1518, according to one or more implementations. In some implementations, the delivery assembly can comprise a flexure portion 1500 and / or a shaft having a generally tubular form and / or an inner lumen. The inner lumen can be configured to receive and / or facilitate the conveyance of one or more wires and / or tissue anchors. The flexure portion 1500 can similarly have a generally tubular form and / or an inner lumen. The flexure portion 1500 can be a part / component of a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0148] The flexure portion 1500 may comprise a network of one or more rings 1518 interconnected by one or more springs 1550 and / or coils. The one or more springs 1550 may be configured to extend between a plurality of rings 1518 of the flexure portion 1500. In some implementations, the rings 1518 may have a circular and / or cylindrical form.

[0149] In some implementations, one or more rings 1518 may include protrusions 1528 configured to mate with corresponding notches 1529 and / or apertures of another ring 1518. Accordingly, one or more rings 1518 may be configured to join together. For example, when one or more rings 1518 are pushed together (e.g., using one or more pull wires configured to apply a pulling force and / or a pushing force to the one or more rings 1518), one or more protrusions 1528 may be configured to slide into one or more notches and / or form a secure attachment. Although pull wires are not shown in FIG. 15, one or more pull wires may extend through a lumen and / or through the wall of the ring 1518 (see, e.g., FIG. 26 of this specification).

[0150] The flexure portion 1500 may be configured to selectively move between a first state (e.g., an expanded and / or substantially flexible state) and a second state (e.g., a compressed and / or substantially rigid state). The expanded and / or flexible state is shown in FIG. 15. In the expanded state, there may be at least a partial separation between the rings 1518 of the flexure portion 1500. The one or more springs 1550 may be configured to interconnect the rings 1518 in the expanded state. After delivery through a narrow anatomical passage and / or upon arrival at a target tissue site, the rings 1518 may be brought together by any suitable means for moving the flexure portion 1500 to the compressed state. In the compressed state, the one or more springs 1550 may be at least partially compressed within the rings 1518.

[0151] In some implementations, the flexure portion 1500 may include a single spring 1550 that extends at least partially along the length of the flexure portion 1500. However, the flexure portion 1500 may include any number of springs 1550. For example, the flexure portion 1500 may include a spring 1550 for each pair of rings 1518.

[0152] FIG. 16 illustrates an exemplary flexure portion 1600 that includes one or more rings 1618 and / or one or more cords 1617 that join the one or more rings 1618 and / or a network of cords 1617, according to one or more implementations. In some implementations, the delivery assembly may include the flexure portion 1600 and / or a shaft having a generally tubular form and / or including an inner lumen. The inner lumen may be configured to receive and / or facilitate the delivery of one or more wires and / or tissue anchors. The flexure portion 1600 may similarly have a generally tubular form and / or include an inner lumen. The flexure portion 1600 may be a part / component of a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0153] The flexure portion 1600 may include a network of one or more rings 1618 interconnected by one or more cords 1617 and / or a bundle of cords. The one or more cords 1617 may be configured to extend between adjacent rings 1618 of the flexure portion 1600. In some implementations, the rings 1618 may have a circular and / or cylindrical form. For example, the rings 1618 may include a tubular piece of material.

[0154] The flexure portion 1600 can be configured to selectively move between a first state (e.g., an extended and / or substantially flexible state) and a second state (e.g., a compressed and / or substantially rigid state). The extended and / or flexible state is shown in FIG. 16. In the extended state, there can be at least a partial separation between the rings 1618 of the flexure portion 1600. One or more cords 1617 can be configured to interconnect the rings 1618 in the extended state. After delivery through a narrow anatomical passageway and / or upon arrival at the target tissue site, the rings 1618 can be brought together by any suitable means for moving the flexure portion 1600 to the compressed state. In the compressed state, one or more cords 1617 can be at least partially located within the rings 1618.

[0155] In some implementations, a single cord 1617 and / or a network / bundle of cords 1617 can be used. In some implementations, a plurality of separate cords 1617 and / or cord bundles can be used to interconnect each pair of rings 1618.

[0156] One or more of the rings 1618 can include one or more protrusions 1622 configured to fit within and / or engage corresponding recesses 1623, notches, and / or openings of other rings 1618. For example, after delivery of the flexure portion 1600 to the target location, a force can be applied to one or more of the rings 1618 to move the one or more rings 1618 closer together. The protrusions 1622 can fit within the recesses 1623 (e.g., similar to a puzzle piece) to allow the rings 1618 to move closer together and / or to form a more rigid connection between the rings 1618 in the rigid state.

[0157] Figure 17 illustrates at least a portion of an assembly 1700 comprising an exemplary flexure portion 1707 with one or more rings 1718 and / or one or more springs 1717 joining the one or more rings 1718, according to one or more implementations. In some implementations, the delivery assembly may comprise the flexure portion 1707 and / or a shaft 1705 having a generally tubular form and / or comprising an inner lumen. The inner lumen may be configured to receive and / or facilitate the delivery of one or more wires and / or tissue anchors. The flexure portion 1707 may similarly have a generally tubular form and / or comprise an inner lumen. The assembly 1700 may be configured as part of a component of an anchor delivery system, or an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0158] The flexure portion 1707 may comprise a network of one or more rings 1718 interconnected by one or more springs 1717 and / or coils. The one or more springs 1717 may be configured to extend between multiple rings 1718 of the flexure portion 1707. In some implementations, the rings 1718 may have a circular and / or cylindrical form. For example, the ring 1718 may comprise a tubular piece of material.

[0159] The flexure portion 1707 may be configured to selectively move between a first state (e.g., an expanded and / or generally flexible state) and a second state (e.g., a compressed and / or generally rigid state). The expanded and / or flexible state is shown in Figure 17. In the expanded state, there may be at least a partial separation between the rings 1718 of the flexure portion 1707. The one or more springs 1717 may be configured to interconnect the rings 1718 in the expanded state. After delivery through a narrow anatomical path and / or upon arrival at a target tissue site, the rings 1718 may be brought together by any suitable means for moving the flexure portion 1707 to the compressed state. In the compressed state, the one or more springs 1717 may be at least partially compressed within the rings 1718.

[0160] In some embodiments, the flexure portion 1707 may comprise a single spring 1717 that extends at least partially along the length of the flexure portion 1707. However, the flexure portion 1707 may comprise any number of springs 1717. For example, the flexure portion 1707 may comprise a spring 1717 between each pair of rings 1718.

[0161] FIG. 18 illustrates at least a portion of an assembly comprising an exemplary flexure portion 1800 that includes one or more segments including a first segment 1801, a second segment 1803, and / or a third segment 1805. The second segment 1803 may be at least partially positioned between the first segment 1801 and the third segment 1805 and / or may comprise one or more cords 1817 that can be screwed together. The second segment 1803 may be configured to join the first segment 1801 and the third segment 1805. In some embodiments, the delivery assembly may comprise a flexure portion 1800 and / or a shaft having a generally tubular form and / or comprising an inner lumen. The inner lumen may be configured to receive and / or facilitate the delivery of one or more wires and / or tissue anchors. The flexure portion 1800 may similarly have a generally tubular form and / or may comprise an inner lumen. In some embodiments, the flexure portion 1800 may be a central portion and / or an end portion of the shaft. The flexure portion 1800 may be a part / component of a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0162] The first segment 1801 and / or the third segment 1805 may comprise one or more coiled wires. In some embodiments, the second segment 1803 may comprise one or more cords forming the first segment 1801 and / or the third segment 1805 and / or may comprise different cords.

[0163] In some implementations, the second segment 1803 may have increased flexibility relative to the first segment 1801, the third segment 1805, and / or other portions of the shaft and / or delivery assembly. The second segment 1803 may be configured to move from a relatively flexible state to a relatively rigid state. For example, by pushing the third segment 1805 toward the first segment 1801 and / or the first segment 1801 toward the third segment 1805, the second segment 1803 can be compressed to assume a more rigid state.

[0164] FIG. 19 illustrates an exemplary flexure portion 1900 with one or more interlocking teeth 1921 according to one or more implementations. In some implementations, the delivery assembly may include the flexure portion 1900 and / or a shaft having a generally tubular form and / or including an inner lumen. The inner lumen may be configured to receive and / or facilitate the delivery of one or more wires and / or tissue anchors. The flexure portion 1900 may similarly have a generally tubular form and / or include an inner lumen. The flexure portion 1900 may be a part / component of a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0165] The flexure portion 1900 can comprise any number of teeth 1921, and / or the teeth 1921 can have any suitable shape and / or size. In some implementations, the teeth 1921 can be configured to fit together in a puzzle-piece fashion. For example, the first segment 1918 can comprise one or more teeth 1921 configured to mate with corresponding teeth 1921 of the second segment 1919. As shown in FIG. 19, the teeth 1921 can comprise T-shaped protrusions from each segment. However, the teeth 1921 can have other shapes. In some implementations, the first segment 1918 and the second segment 1919 can have substantially the same size and / or shape such that the protrusions of the first segment 1918 fit into the recesses of the second segment 1919 and / or vice versa, and can be staggered. The teeth 1921 of one or more segments can be continuous around the entire circumference of the flexure portion 1900.

[0166] The flexure portion 1900 can be configured to selectively move between a first state (e.g., an expanded and / or substantially flexible state) and a second state (e.g., a compressed and / or substantially rigid state). In the expanded state, there can be at least a partial separation between the teeth 1921 of adjacent segments of the flexure portion 1500. After delivery through a narrow anatomical passage and / or upon arrival at a target tissue site, the teeth 1921 can be brought together by any suitable means for moving the flexure portion 1900 to the compressed state. In the compressed state, one or more of the teeth 1921 can be locked together and / or can be more closely coupled than in the expanded state. In some implementations, the teeth 1921 can comprise locking features (e.g., pegs and / or notches) configured to provide a secure attachment between the teeth 1921.

[0167] FIG. 20 (FIGS. 20-1 and 20-2) is a flowchart illustrating steps of an exemplary method or process 2000 for delivering one or more tissue anchors via a shaft having a flexure portion according to one or more implementations. FIG. 21 (FIGS. 21-1 and 21-2) provides exemplary images corresponding to the steps of the method / process 2000 of FIG. 20.

[0168] In step 2002, process 2000 involves delivering one or more tissue anchors 2112 to a target tissue site (e.g., tricuspid valve 6) via a delivery shaft 2105 that is in a first state (e.g., an expanded and / or flexible state) during delivery, as shown in image 2102 of FIG. 21. Although the delivery process of tricuspid valve 6 is illustrated in FIG. 21, the steps of process 2000 may be applicable to delivery at various tissue sites, including the mitral valve. Delivery shaft 2105 may be part of a component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0169] Delivery shaft 2105 may include a flexure portion 2133 that includes any of a variety of features to facilitate transition of the delivery shaft from a first state to a second state (e.g., a compressed and / or rigid state) and / or from the second state to the first state. For example, as shown in image 2102, flexure portion 2133 may include one or more rings 2118 interconnected by one or more tabs 2117. However, the flexure portion may have any of the various features described herein with respect to the flexure portion. Shaft 2105 and / or flexure portion 2133 may be delivered to the right atrium 5 and / or the target tissue site via one or more catheters 2101 (e.g., an outer shaft).

[0170] In step 2004, process 2000 involves changing delivery shaft 2105 and / or flexure portion 2133 from a first state to a second state (e.g., a compressed and / or rigid state). In some implementations, as shown in image 2104 of FIG. 21, flexure portion 2133 may include one or more tabs 2117 configured to at least partially disconnect and / or remove from one or more rings 2118, enabling the one or more rings 2118 to move together and join and / or move closer to each other. Other exemplary flexure portions 2133 may include springs, cords, interlocking teeth, and / or other features configured to facilitate the transition of shaft 2105 from a first state to a second state and / or vice versa.

[0171] In the implementation shown in image 2104, tabs 2117 can each be disconnected from one side from rings 2118 and / or can extend substantially perpendicular and / or axially from shaft 2105 and / or tissue anchor 2112. As a result, rings 2118 can be enabled to fill the space previously occupied by tabs 2117. During the first state shown in image 2102, tabs 2117 can extend substantially in line with shaft 2105 and / or can enable improved flexibility of shaft 2105. For example, one or more tabs 2117 can function as a hinge and / or can include a flexible structure that facilitates bending of shaft 2105. In some implementations, rings 2118 can include substantially rigid and / or solid material and / or can have minimal flexibility. During the second state illustrated in image 2104, one or more rings 2118 can be joined together and / or can close the gap between rings 2118. As a result, the rigidity of rings 2118 can cause flexure portion 2133 to have a substantially rigid structure.

[0172] The shaft 2105 may further include one or more proximal segments 2131 that extend between the bending portion 2133 and the handle and / or other proximal devices. The one or more proximal segments 2131 may have a generally tubular structure and / or may have a generally flexible, semi-flexible, and / or rigid structure. In some implementations, as shown in the image 2104, at least a portion of the one or more proximal segments 2131 adjacent to the bending portion 2133 may be at least partially flexible to allow the shaft 2105 to bend.

[0173] In step 2006, the process 2000 involves driving one or more tissue anchors 2112 into the tissue using the delivery shaft 2105 and / or the bending portion 2133 while the bending portion 2133 is in the second state, as shown in the image 2106 of FIG. 21. In some implementations, the increased rigidity of the shaft 2105 resulting from the bending portion 2133 being in the second state may facilitate driving the tissue anchor 2112 into the tissue. For example, the bending portion 2133 may not bend in response to the driving pressure from the shaft 2105 into the bending portion 2133.

[0174] FIGS. 22A and 22B illustrate at least a portion of an exemplary delivery shaft 2205 that includes a bending portion that includes one or more springs extending across a break portion of the delivery shaft 2205, according to one or more implementations. In some implementations, the delivery shaft 2205 may include a driver 2212 at the distal end of the delivery shaft 2205 configured to drive one or more tissue anchors into a target tissue location (e.g., within or around one or more valves of the heart). The driver 2212 may have an increased width and / or diameter relative to the width and / or diameter of other portions of the delivery shaft 2205. The delivery shaft 2205 may be a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0175] In some embodiments, the delivery shaft 2205 may include a bend at or near the distal end of the driver 2212 and / or the delivery shaft 2205. The bend may be configured to facilitate a change from a first state (e.g., substantially linear and / or continuous) to a second state (e.g., substantially bent and / or discontinuous), and / or from the second state to the first state.

[0176] The bend may include a break 2252 and / or a cut in the delivery shaft 2205. In some embodiments, the break 2252 may include a cut through the shaft 2205 that separates the shaft into a proximal segment 2206 and a distal segment 2208. The break 2252 is shown as a diagonal cut through the shaft 2205 in FIGS. 22A and 22B, but the break 2252 may be any type of cut and / or may have any angle.

[0177] In some embodiments, the bend may include one or more springs 2250 and / or similar devices that extend across the break 2252 and are at least partially located within the proximal segment 2206 and the distal segment 2208. The one or more springs 2250 may be configured to form a bridge between the proximal segment 2206 and the distal segment 2208 and / or to push the proximal segment 2206 and the distal segment 2208 into contact with each other. The one or more springs 2250 may be configured to be in a static, relaxed, and / or compressed form when the proximal segment 2206 and the distal segment 2208 are in continuous and / or linear alignment, as shown in FIG. 22A.

[0178] As shown in FIG. 22B, one or more springs 2250 can be configured to expand and / or torsionally rotate as needed to maintain the connection between the proximal segment 2206 and the distal segment 2208 even when the proximal segment 2206 and the distal segment 2208 are not in contact with and / or not aligned with each other. If the break 2252 between the proximal segment 2206 and the distal segment 2208 widens, the one or more springs 2250 can assume an expanded and / or stretched configuration so as to extend across any gap between the proximal segment 2206 and the distal segment 2208.

[0179] In some implementations, the shaft 2205 can have a default and / or natural alignment of the proximal segment 2206 to the distal segment 2208. For example, the proximal edge 2221 of the proximal segment 2206 can be configured to align with the distal edge 2223 of the distal segment 2208 and / or the proximal segment 2206, and the distal segment 2208 can naturally contact. In a first state, the proximal edge 2221 and the distal edge 2223 can contact and / or be close to each other. The one or more springs 2250 can be configured to maintain the alignment between the proximal segment 2206 and the distal segment 2208. Thus, the one or more springs 2250 can be configured to resist misalignment between the proximal segment 2206 and the distal segment 2208. For example, when a torsional force is applied to the proximal segment 2206, the one or more springs 2250 can be configured to maintain alignment and / or resist the proximal segment 2206 from twisting out of alignment with the distal segment 2208. If the proximal segment 2206 and / or the distal segment 2208 twist out of alignment, the one or more springs 2250 can be configured to elastically deform as needed to maintain the bridge between the proximal segment 2206 and the distal segment 2208 while providing a reaction force to pull the proximal segment 2206 and the distal segment 2208 back into alignment.

[0180] The flexion portion may be configured to provide torque limitation at the distal end and / or the distal portion 2208 of the shaft 2205. For example, the flexion portion may be configured to provide measurement and / or reading when the amount of torque in the distal portion 2208 of the shaft 2205 exceeds a given amount. The flexion portion may be designed to become misaligned when the distal portion 2208 of the shaft 2205 reaches a desired and / or set maximum torque level.

[0181] The shaft 2305 is shown to include an angled break 2252 (e.g., a break and / or cut of about 45 degrees), although the break 2252 may have a different angle and / or may be substantially perpendicular. One or more coils 2250 and / or springs may be configured to maintain alignment of the proximal segment 2206 and the distal segment 2208 while the shaft 2205 is being twisted until torsional rotation causes the torque of the distal segment 2208 to exceed a predetermined level. For example, one or more coils 2250 may be configured to transmit torque from the proximal segment 2206 to the distal segment 2208. In some implementations, the proximal segment 2206 and / or the distal segment 2208 may additionally or alternatively include various features to increase friction and / or attachment between the proximal segment 2206 and the distal segment 2208 to facilitate torque transmission from the proximal segment 2206 to the distal segment 2208. For example, the proximal segment 2206 and / or the distal segment 2208 may include one or more pegs, bumps, and / or other protrusions configured to mate with corresponding notches and / or depressions in the distal segment 2208 and / or the proximal segment 2206.

[0182] The flexion portion can be configured to facilitate various methods of testing how well the tissue anchor is fixed within the tissue. For example, after the shaft 2205 is at least somewhat twisted to at least partially embed the tissue anchor at the distal end of the shaft 2205 within the tissue, the surgeon can axially pull back on the shaft 2205 and / or on the proximal segment 2206 of the shaft 2205. The amount of resistance presented by the distal segment 2208 can indicate how well the tissue anchor is embedded, and / or can be reflected by how easily the proximal segment 2206 is pulled away from the distal segment 2208 to create a gap 2252 between the proximal segment 2206 and the distal segment 2208. For example, if the distal segment 2208 remains in place while the proximal segment 2206 is being pulled away from the distal segment 2208 and / or while a predetermined amount of separation is achieved before the distal segment 2208 is withdrawn, the tissue anchor may be suitably embedded and may not require further fixation. In contrast, if the distal segment 2208 is pulled away from the tissue by the proximal segment 2206 and / or does not provide a suitable amount of resistance when the proximal segment 2206 is pulled, further fixation may be required.

[0183] In some implementations, the break portion 2252 can be configured to allow at least partial separation between the proximal segment 2206 and the distal segment 2208 during delivery of the shaft 2205 to the target tissue location. For example, as the shaft 2205 moves around a bend within the patient's anatomical structure, the break portion 2252 can expand to allow increased flexion of the shaft 2205. The shaft 2205 can be at least partially constructed from a braided cable to allow some flexibility of the shaft 2205. Further, the thickness of the shaft 2205 can be variable along the shaft 2205 as needed to facilitate delivery of the shaft 2205. For example, the shaft 2205 can have a reduced thickness at or near the flexure portion and / or distal portion of the shaft 2205 to facilitate flexion of the flexure portion and / or distal portion.

[0184] Figures 23A and 23B illustrate the driving process of one or more tissue anchors 2302 into tissue 10 according to one or more implementations. In some implementations, the shaft 2305 may include a driver 2312 configured to interface with the tissue anchor 2302 (e.g., at the head 2380 portion of the anchor 2302) to screw and / or push the tissue anchor 2302 into the tissue. The shaft 2305 may include a bent portion having one or more springs 2350 bridging a break portion 2352 within the shaft 2305. The break portion 2352 may represent a separation between a proximal segment 2306 and a distal segment 2308 of the shaft 2305. Prior to delivery and / or before the tissue anchor at the distal end of the shaft 2305 is fully implanted, the contact between the proximal segment 2306 and the distal segment 2308 may be in the same plane. The driver 2312 and / or the shaft 2305 and associated features may be configured as an anchor delivery system (which may be similar to other anchor delivery systems herein) or as a part / component of an anchor delivery system.

[0185] In some implementations, the shaft 2305 may be configured to be twisted to cause a corresponding torsional rotation of the driver 2312 and / or the tissue anchor 2302. In some implementations, the tissue anchor 2302 may include a coil 2327 configured to be implanted into the tissue 10 when twisted. Thus, when the shaft 2305 is twisted, the tissue anchor 2302 may be further implanted into the tissue 10 as shown in FIG. 23B.

[0186] When at least a portion of the tissue anchor 2302 (e.g., the coil of the tissue anchor 2302) is fully implanted into the tissue 10, the base portion of the tissue anchor 2302 may press against the tissue 10 and / or the tissue anchor 2302 may provide an increased amount of resistance to the driver 2312 and / or the shaft 2305. This increased resistance may resist further torsional rotation of the distal segment 2308 of the shaft 2305.

[0187] The proximal segment 2306 can be positioned between the distal segment 2308 and the handle and / or other control mechanisms. Forces from the handle and / or other control mechanisms can first be applied to the proximal segment 2306 and then, via one or more springs 2350, to the distal segment 2308 and / or converted to friction between the proximal segment 2306 and the distal segment 2308. If the distal segment 2308 presents increased resistance as a result of the tissue anchor 2302 being fully and / or at least partially embedded in the tissue 10, the torsional rotation of the proximal segment 2306 may not be converted to torsional rotation of the distal segment 2308. As a result, the proximal segment 2306 can twist out of alignment with the distal segment 2308, as shown in FIG. 23B.

[0188] When the proximal segment 2306 twists out of alignment with the distal segment 2308, the break 2352 between the proximal segment 2306 and the distal segment 2308 can at least partially widen and / or one or more gaps can be formed between the proximal segment 2306 and the distal segment 2308. Further, the proximal edge 2321 of the proximal segment 2306 can move out of contact and / or alignment with the distal edge 2323 of the distal segment 2308.

[0189] In some implementations, the bent portion of the shaft 2305 can be at least partially visible to the surgeon via any suitable scope device and / or similar means. Thus, when the proximal segment 2306 and the distal segment 2308 move out of alignment, the misalignment can be visible and / or significant to the surgeon. Using this information, the surgeon and / or drive mechanism can interrupt the application of the driving force and / or disconnect the shaft 2305 and / or driver 2312 from the tissue anchor 2302. In some implementations, the bent portion can be configured to function as a slip clutch and / or configured to prevent being applied beyond a configured threshold torque.

[0190] Before the shaft 2305 reaches distortion and / or becomes misaligned, various factors that determine how much torque can be applied may include the strength of the coil 2350 and / or the surface characteristics (e.g., coefficient of friction) between the proximal segment 2306 and the distal segment 2308. The shaft 2305 can be calibrated based on how much torque may be required to drive the tissue anchor into the tissue. The bending portion can be configured to limit the forces applied in the torque direction and / or push / pull direction and / or linear direction.

[0191] The inclined and / or angled break 2352 can be configured to facilitate torque and / or linear direction testing. For example, the break 2352 can be configured to cause distortion as a result of excessive torque and / or pulling force. The separation of the proximal segment 2306 and the distal segment 2308 can be identified in any suitable manner, which may include fluoroscopic and / or electrical. In some implementations, the break 2352 can be inclined and / or helical.

[0192] Friction along the length of the shaft 2305 can at least partially depend on and / or be determined by the curvature of the catheter around the shaft 2305. For example, the greater the curvature of the catheter around the shaft 2305, the greater the friction in the shaft 2305. In some cases, the catheter around the shaft 2305 can somewhat restrict the shaft 2305 and / or help prevent and / or inhibit the shaft 2305 from shifting and / or otherwise getting out of alignment and / or can accumulate friction with the shaft 2305 and hold the shaft 2305 in a fixed position. If the outer catheter resists the movement of the shaft 2305, some torque in the shaft 2305 can be lost.

[0193] FIG. 24 illustrates an exemplary shaft 2405 with a flexure portion according to one or more implementations. The shaft 2405 can be a component / part of an anchor delivery system (e.g., similar to other anchor delivery systems herein). The flexure portion can include one or more coils 2450 that are at least partially located within the shaft 2405 and / or configured to extend between a distal segment 2408 and a proximal segment 2406 of the shaft 2405. The flexure portion can further include a break 2452 and / or a gap between the proximal segment 2406 and the distal segment 2408. The break 2452 can be a substantially vertical and / or 90-degree cut of the shaft 2405 as illustrated in FIG. 24. However, the break 2452 can include a diagonal cut and / or have any suitable angle.

[0194] In some implementations, the shaft 2405 and / or the flexure portion can include one or more edge portions that can project from the shaft 2405. For example, the proximal segment 2406 can include a first end portion 2421 and / or the distal segment 2408 can include a second end portion 2432. The first end portion 2421 and / or the second end portion 2432 can be located on opposite sides of the break 2452 and / or configured to contact each other in a rest state of the shaft 2405. The shaft 2405 is illustrated in FIG. 24 with a gap formed between the proximal segment 2406 and the distal segment 2408 for illustrative purposes. However, one or more coils 2450 and / or springs can be configured to pull the proximal segment 2406 and the distal segment 2408 together such that the first end portion 2421 and the second end portion 2432 contact in a rest and / or default state.

[0195] The shaft 2405 can be configured to be twisted to facilitate driving one or more tissue anchors into tissue via a driver 2412 at the distal end of the shaft 2405. Based at least in part on a break 2452 between the proximal segment 2406 and the distal segment 2408, the proximal segment 2406 can be configured to twist out of alignment with the distal segment 2408 when at least a portion of the tissue anchor is fully embedded in the tissue.

[0196] Figures 25A and 25B illustrate an exemplary delivery device 2500 for delivering one or more catheters and / or medical devices to a target location within the body according to one or more implementations. The delivery device 2500 can be configured as an anchor delivery system (which can be similar to other anchor delivery systems herein) or as a part / component of an anchor delivery system. The delivery device 2500 can include a plurality of handles and / or engagement mechanisms including a first handle 2511 and / or a second handle 2513. The first handle 2511 can be configured to extend and / or control a wire 2520 (e.g., a nitinol wire) and / or an extension of a medical implant through the outer catheter 2505 and / or the inner catheter 2515. The second handle 2513 can be configured to extend and / or control an extension of one or more pull wires. The one or more pull wires can be at least partially located within the outer catheter 2505 and / or the inner catheter 2515 and / or can be configured to facilitate movement of one or more bend portions in the outer catheter 2505 and / or the inner catheter 2515 from an expanded and / or flexible state to a compressed and / or rigid state. Figure 25A illustrates the device 2500 in a first state where the first handle 2511 is not engaged to produce an extension and / or protrusion of the wire 2520. Figure 25B illustrates a second state of the device 2500 where the first handle 2511 is pushed towards the second handle 2513 to cause an extension and / or protrusion of the wire 2520 relative to the outer catheter 2505 and / or the inner catheter 2515.

[0197] FIG. 26 illustrates an exemplary flexure portion 2600 comprising one or more pull wires 2630 configured to control the positioning of one or more rings 2618 and / or one or more springs 2650 that join the one or more rings 2618, according to one or more embodiments. In some embodiments, the delivery assembly may comprise the flexure portion 2600 and / or a shaft having a generally tubular form and / or comprising an inner lumen. The inner lumen may be configured to receive and / or facilitate the conveyance of one or more wires and / or tissue anchors. The flexure portion 2600 may similarly have a generally tubular form and / or comprise an inner lumen. The flexure portion 2600 may be a part / component of an anchor delivery system (and may be identical or similar to other anchor delivery systems herein).

[0198] The flexure portion 2600 may comprise a network of one or more rings 2618 interconnected by one or more springs 2650 and / or coils. The one or more springs 2650 may be configured to extend between multiple rings 2618 of the flexure portion 2600. In some embodiments, the rings 2618 may have a circular and / or cylindrical form.

[0199] In some embodiments, the one or more rings 2618 may comprise protrusions 2628 configured to mate with corresponding notches 2629 and / or openings of another ring 2618. Accordingly, the one or more rings 2618 may be configured to join together.

[0200] The flexible portion 2600 can be configured to selectively move between a first state (e.g., an expanded and / or substantially flexible state) and a second state (e.g., a compressed and / or substantially rigid state). The expanded and / or flexible state is shown in FIG. 26. In the expanded state, there can be at least a partial separation between the rings 2618 of the flexible portion 2600. One or more springs 2650 can be configured to interconnect the rings 2618 in the expanded state. After delivery through a narrow anatomical pathway and / or upon arrival at the target tissue site, the rings 2618 can be brought together by any suitable means for moving the flexible portion to the compressed state. In the compressed state, one or more springs 2650 can be at least partially compressed within the rings 2618.

[0201] In some implementations, the flexible portion 2600 can comprise a single spring 2650 that extends at least partially along the length of the flexible portion 2600. However, the flexible portion 2600 can comprise any number of springs 2650. For example, the flexible portion 2600 can comprise a spring 2650 for each pair of rings 2618.

[0202] The flexible portion 2600 and / or the delivery device for delivering the flexible portion 2600 can comprise one or more pull wires 2630 that extend at least partially through one or more of the rings 2618 and are configured to control the position of the one or more rings 2618 relative to each other. For example, one or more pull wires 2630 can pass through the openings of the rings 2618 and / or can be pulled to pull the distal ring 2618 towards the proximal ring 2618. By pulling the rings 2618 together, the one or more pull wires 2630 can be configured to facilitate movement of the flexible portion 2600 from the flexible and / or expanded state to the compressed and / or rigid state.

[0203] The bending portion 2600 is shown to include a first pull wire 2630a and a second pull wire 2630b. However, the bending portion 2600 and / or the delivery device may include any number of pull wires 2630. For example, the bending portion 2600 and / or the delivery device may include four pull wires 2630. In some implementations, as shown in FIG. 26, two pull wires 2630 may be located on substantially opposite sides of the ring 2618. In some implementations, one or more pull wires 2630 may be configured to extend through each ring 2618 of the bending portion 2600. However, one or more pull wires 2630 may be configured to extend through only a portion of the bending portion 2600.

[0204] According to one or more implementations of the present disclosure, a method for delivering one or more tissue anchors includes delivering an elongate shaft carrying one or more tissue anchors at a distal end of the elongate shaft to a target tissue location. The elongate shaft includes a bending portion configured to move between a first state and a second state. The method may further include driving one or more tissue anchors into the target tissue location and moving the bending portion from the first state to the second state to facilitate moving the bending portion from the second state to the first state.

[0205] Moving the bending portion from the first state to the second state may involve compressing the bending portion. In some implementations, moving the bending portion from the first state to the second state involves twisting the elongate shaft until a gap is formed in the bending portion.

[0206] In some implementations, the bending portion includes at least one removable tab between segments of the bending portion. The segments may be in the shape of rings.

[0207] The bending portion may include an interlocking network of teeth. In some implementations, the bending portion includes a coil extending through the lumen of the bending portion.

[0208] In some embodiments, the coil is configured to interconnect segments of the bent portion. The bent portion may comprise a cut passing through the elongated shaft.

[0209] Moving the bent portion from the first state to the second state involves pulling one or more pull wires extending at least partially through the bent portion.

[0210] The above method can be performed in a living animal or in a simulation, for example, on a cadaver, cadaver heart, simulator (e.g., a simulated body part, heart tissue), etc.

[0211] Some embodiments of the present disclosure relate to a system for delivering one or more tissue anchors, comprising an elongated shaft carrying the one or more tissue anchors to a target tissue location at a distal end of the elongated shaft. The elongated shaft comprises a bent portion configured to move between a first state and a second state.

[0212] In some embodiments, the system further comprises an inner shaft configured to extend at least partially through the lumen of the elongated shaft. The system may further comprise an outer shaft configured to at least partially surround the elongated shaft.

[0213] The bent portion may be configured to move from the first state to the second state by compressing the bent portion. In some embodiments, the bent portion is configured to form a gap in response to a torsional rotation of the elongated shaft.

[0214] In some embodiments, the bent portion comprises at least one removable tab between segments of the bent portion. The segments can be in a ring shape.

[0215] The flexure portion may comprise an interlocking network of teeth. In some implementations, the flexure portion comprises a coil extending through the lumen of the flexure portion.

[0216] In some implementations, the coil is configured to interconnect segments of the flexure portion. The flexure portion may comprise a cutout through an elongate shaft.

[0217] The system may further comprise one or more pull wires configured to extend at least partially through the flexure portion. In some implementations, the one or more pull wires extend at least partially through multiple segments of the flexure portion.

[0218] Sterilization Any of the various systems, devices, instruments, etc. in the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and any of the methods herein may include sterilization of the associated system, device, instrument, etc. as one of the steps of the method (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0219] Compressible anchor driver Figures 27A - 27C illustrate an exemplary anchor delivery system 2700 configured for the delivery of one or more tissue anchors, according to one or more examples. The anchor delivery system 2700 may be configured to be compressible and / or adjustable. The anchor delivery system 2700 may include one or more shafts and / or other components (e.g., reinforcement components, steering components, softening components, flexible components, etc.) or features. The anchor delivery system may include a portion or component (e.g., outer shaft, inner shaft, rod, wire, extension, etc.) that moves (e.g., axially, rotationally, etc.) relative to another portion or component (e.g., outer shaft, inner shaft, rod, wire, extension, etc.) to change one or more of the hardness, rigidity, flexibility, flexibility, etc. of the anchor delivery system.

[0220] In some implementations, system 2700 can be configured to extend the outer shaft 2715 of system 2700 without torsionally rotating the outer shaft 2715. The outer shaft 2715 may not be required to resist a torque load. For example, the accumulation of torque at the distal end of the outer shaft 2715 can cause the coupling of the outer shaft 2715 and / or one or more anchors interfacing with the distal end of the outer shaft 2715. System 2700 can additionally include an inner shaft 2717. The outer shaft 2715 and / or the inner shaft 2717 can be coupled to a gripper (not shown, see, e.g., FIG. 11) at the distal end of system 2700.

[0221] In some implementations, the outer shaft 2715 and / or the inner shaft 2717 can be configured to receive one or more wires 2710 (e.g., nitinol wires). Although only a single wire 2710 is shown in FIGS. 27A - 27C, system 2700 can include any number of wires 2710. In some implementations, one or more wires 2710 can be configured to move the bend portions of the outer shaft 2715 and / or the inner shaft 2717 between multiple states. For example, one or more wires 2710 can include pull wires configured to be selectively tensioned to cause movement of the bend portions of various shafts and / or catheters.

[0222] In some implementations, the outer shaft 2715 and / or the inner shaft 2717 may comprise a laser cut hypo tube and / or similar components. In some implementations, the outer shaft 2715 and / or the inner shaft 2717 may comprise one or more bits and / or similar devices at the distal end of the outer shaft 2715 and / or the inner shaft 2717 configured to fit with a gripper at the distal end of the system 2700. The torsional rotation of the outer shaft 2715 and / or the inner shaft 2717 may cause coupling problems in the gripper and / or other areas. Such coupling problems may arise from metal-to-metal contact between the metal gripper and / or the metal outer shaft 2715 and / or the inner shaft 2717. In some implementations, the system 2700 may advantageously not require torsional rotation of the outer shaft 2715 and / or may have a longitudinal extension of the outer shaft 2715 with minimal or no torque on the outer shaft 2715. The system 2700 may more advantageously prevent unnecessary and / or excessive compression of the inner shaft 2717.

[0223] In some implementations, the outer shaft 2715 and / or the inner shaft 2717 may be welded to the gripper to fixedly position the gripper and / or the distal end of the system 2700. In some implementations, the system 2700 may comprise a nut 2712 (e.g., a screw, bolt, and / or threaded member) configured to apply force and / or compression to the push knob 2714 and / or the outer shaft 2715. In some implementations, the outer shaft 2715 may be coupled to the push knob 2714. In some implementations, the nut 2712 may be threaded and / or may be configured to rotate torsionally along the threaded surface of the setscrew 2719 (e.g., a threaded screw).

[0224] The torsional rotation and / or torque of nut 2712 may not be converted to the knob 2714 and / or the outer shaft 2715. For example, nut 2712 may be configured to slide along the surface of knob 2714 and push on knob 2714 without causing a corresponding torsional rotation in knob 2714. In some implementations, system 2700 may include a washer and / or a sliding member (e.g., a bearing surface, a Teflon® washer, etc.) between nut 2712 and knob 2714 to prevent frictional torque transfer from nut 2712 to knob 2714. Nut 2712 may not be attached to outer shaft 2715. Knob 2714 may be configured not to twist in response to the force applied from nut 2712.

[0225] In some implementations, knob 2714 may include a channel 2720 configured to receive a pin 2721 and / or a protrusion extending from inner shaft 2717. Pin 2721 may be configured to prevent rotation and / or extension of knob 2714. Channel 2720 may have a generally rectangular shape and / or may include a recess and / or cavity passing through knob 2714. Inner shaft 2717 may be configured to extend at least partially through knob 2714 and / or screw 2719.

[0226] As shown in FIG. 27B, in some implementations, rotation of nut 2712 (e.g., clockwise and / or counterclockwise rotation) may cause an axial extension of the nut along screw 2719. For example, nut 2712 may be configured to slide and / or glide along the threads of screw 2719. In some implementations, the movement and / or extension of nut 2712 along screw 2719 may be configured to cause a corresponding movement and / or extension of knob 2714. For example, nut 2712 may be configured to press against knob 2714 and / or exert an axial force and / or a pressing force on knob 2714. Knob 2714 may be configured not to twist in response to the force applied by nut 2712.

[0227] In some implementations, system 2700 may include one or more arms 2726 configured to be coupled to nut 2712 and / or knob 2714 and / or to form one or more bridges between nut 2712 and knob 2714. For example, knob 2714 may include one or more pegs 2728 configured to be gripped and / or otherwise engaged by one or more arms 2726. In some implementations, one or more pegs 2728 may include an oval extension from knob 2714 that extends around the entire circumferential surface of knob 2714 and / or may include one or more discrete protrusions configured to engage a discrete arm 2726 coupled to nut 2712. FIGS. 27A-27C illustrate pegs 2728 extending from knob 2714, but knob 2714 may additionally or alternatively include one or more cavities, openings, and / or recesses configured to receive corresponding protrusions from one or more arms 2726.

[0228] In some implementations, one or more arms 2726 may be configured to apply a pushing and / or pulling force to one or more pegs 2728. For example, as nut 2712 extends, one or more arms 2726 may be configured to apply a force to the proximal surface of one or more pegs 2728. Similarly, when nut 2712 rotates in the opposite direction as illustrated in FIG. 27C, nut 2712 may retract and / or may be configured to apply a pulling force to the distal surface of one or more pegs 2728. In some implementations, one or more arms 2726 may include proximal and / or distal walls and / or protrusions configured to engage the proximal and / or distal sides of peg 2728, respectively. In some implementations, one or more arms 2726 may include a hollow spherical extension configured to surround one or more pegs 2728.

[0229] In some implementations, system 2700 may include a stopper 2722 (e.g., a stopper nut) configured to prevent the nut 2712 from retreating beyond a particular point along the screw 2719. For example, the stopper 2722 may be disposed along the screw 2719 between the nut 2712 and the handle 2718. The system 2700 may include a handle nut 2724 disposed between the screw 2719 and the handle 2718.

[0230] Figures 28A - 28D illustrate an exemplary bent portion 2800 of a delivery catheter according to one or more implementations. The delivery catheter may be configured as an anchor delivery system (which may be similar to other anchor delivery systems herein) or as a part / component of an anchor delivery system. In some implementations, the bent portion 2800 may include one or more pull wires 2830 configured to control the positioning of one or more segments 2818 (e.g., rings) of the bent portion 2800. In some implementations, the delivery assembly may include the bent portion 2800 and / or a shaft (e.g., a catheter) having a generally tubular form and / or including an inner lumen. The inner lumen may be configured to receive and / or facilitate the conveyance of one or more wires and / or tissue anchors. The bent portion 2800 may similarly have a generally tubular form and / or include an inner lumen. In some implementations, the bent portion 2800 may include a network of one or more segments 2818 interconnected by one or more pull wires 2830. In some implementations, the segments 2818 may have a circular and / or cylindrical form.

[0231] In some implementations, one or more segments 2818 may include protrusions 2828 configured to mate with corresponding notches 2829 and / or openings of another segment 2818. Accordingly, one or more segments 2818 may be configured to join and / or interconnect together.

[0232] In some embodiments, the flexure portion 2800 can be configured to selectively move between a plurality of states including the open state (e.g., expanded and / or substantially flexible state) illustrated in FIG. 28A, the closed state (e.g., compressed and / or substantially rigid state) illustrated in FIG. 28B, the flexed state illustrated in FIG. 28C, and / or the zigzag state illustrated in FIG. 28D. In the expanded state, there can be at least a partial separation between segments 2818 of the flexure portion 2800. One or more pull wires 2830 can be configured to interconnect segments 2818 in the expanded state. After delivery through a narrow anatomical passageway and / or upon arrival at the target tissue site, segments 2818 can be brought together by any suitable means for moving the flexure portion 2800 to a compressed state.

[0233] In some embodiments, the transition between the various states of the flexure portion 2800 can be controlled via one or more pull wires 2830. For example, the pull wires 2830 can be selectively tensioned and / or pulled to, for example, push and / or pull the distal segment 2818a towards the proximal segment 2818b and / or to move the various segments 2818 together. To move all of the segments 2818 together, the plurality of pull wires 2830 can be tensioned and / or pulled in a simultaneous and / or synchronized manner such that all of the pull wires 2830 apply a force to the segments 2818 to move the segments 2818 towards each other. As a result, the flexure portion 2800 can move to the compressed configuration shown in FIG. 28B.

[0234] In some implementations, only a portion of the pull wire 2830 may be tensioned and / or pulled. For example, the first pull wire 2830a may not be tensioned and / or may have a relatively low tension, and / or the second pull wire 2830b may be tensioned and / or may have a relatively high tension. As a result, the second pull wire 2830 may cause the joining of the segments 2818 on one side of the bent portion 2800, and / or the first pull wire 2830a may allow for the separation between the segments 2818 on the other side of the bent portion 2800. The bent portion 2800 may form a bend toward the second pull wire 2830b, as shown in FIG. 28C.

[0235] The relaxation and / or lack of tension in one or more of the pull wires 2830 may allow the bent portion 2800 to bend and / or move in various directions. For example, the bent portion 2800 may form a zigzag shape in which the distal segment 2818a and the proximal segment 2818b may face in different directions, as shown in FIG. 28D. The bent portion 2800 may be configured to move in response to the movement of an anatomical structure in contact with the bent portion 2800, allowing the bent portion 2800 to maintain contact with the anatomical structure and / or one or more anchors fixed within the anatomical structure while the anatomical structure moves.

[0236] In some implementations, one or more of the pull wires 2830 may be configured to extend at least partially through one or more of the segments 2818 to control the position of one or more of the segments 2818 relative to each other. For example, one or more of the pull wires 2830 may pass through an opening in the segment 2818 and / or may be pulled to pull the distal segment 2818 toward the proximal segment 2818. By pulling the segments 2818 together, one or more of the pull wires 2830 may be configured to facilitate the movement of the bent portion 2800 from a flexible and / or expanded state to a compressed and / or rigid state.

[0237] The flexion portion 2800 is shown to include a first pull wire 2830a, a second pull wire 2830b, and / or an additional pull wire 2830. However, the flexion portion 2800 and / or the delivery device may include any number of pull wires 2830. For example, the flexion portion 2800 and / or the delivery device may include four pull wires 2830. In some implementations, as shown in FIG. 28, two pull wires 2830 may be located on substantially opposite sides of the segment 2818. In some implementations, one or more pull wires 2830 may be configured to extend through each segment 2818 of the flexion portion 2800. However, one or more pull wires 2830 may be configured to extend through only a portion of the flexion portion 2800.

[0238] FIG. 29 (FIGS. 29-1 and 29-2) provides a flowchart illustrating an exemplary method or process 2900 for driving one or more tissue anchors and / or evaluating the fixation of one or more tissue anchors according to one or more examples. FIG. 30 (FIGS. 30-1 and 30-2) provides images associated with the steps of the process 2900 of FIG. 29.

[0239] In some implementations, at step 2902, method / process 2900 involves compressing catheter 3001 (e.g., an elongate shaft) and / or other delivery devices and / or a bend portion of catheter 3001 to facilitate driving one or more anchors 3005 into tissue, as shown in image 3000a of FIG. 30. Catheter 3001 can be configured as an anchor delivery system (which may be similar to other anchor delivery systems herein) or as a part / component of an anchor delivery system. Catheter 3001 can be configured to be movable between multiple states and / or can include multiple configurations. For example, during delivery through the body, catheter 3001 can be configured to assume a substantially flexible configuration (see, e.g., FIGS. 28A and / or 28D). Catheter 3001 can include one or more pull wires 3030 configured to control the positioning of various segments 3018 of catheter 3001 relative to each other. During delivery, the one or more pull wires 3030 can have a substantially relaxed state and / or can be configured to allow segments 3018 to move independently of other segments 3018 and / or to form gaps between segments 3018. Catheter 3001 can include any number of segments 3018 and / or can include two or more segments 3018.

[0240] Before compressing the catheter 3001, the catheter 3001 and / or other delivery systems can be delivered to the target tissue location via one or more blood vessels and / or heart cavities. The bent portion of the catheter 3001 can be in a flexible state during delivery and / or can be moved to a compressed state using one or more pull wires 3030 and / or similar devices to facilitate driving one or more tissue anchors into the target tissue location. The pull wire 3030 can be configured to interconnect segments 3018 of the catheter 3001. The pull wire 3030 can be released to move the bent portion of the catheter 3001 from a compressed state to a flexible state. The catheter 3001 can be configured to carry and / or engage with one or more tissue anchors (e.g., at the distal end of the catheter 3001).

[0241] Upon reaching the target tissue site, one or more pull wires 3030 can be tensioned and / or pulled to pull segments 3018 together and / or to move the catheter 3001 to a substantially compressed and / or rigid form. The rigid form of the catheter 3001 can enable the catheter 3001 to resist bending and / or torsional rotation while the anchor 3005 is being driven into the tissue (e.g., within the valve leaflet 10). In some implementations, the anchor 3005 can be configured to secure the prosthetic valve leaflet 3003 and / or similar devices.

[0242] The catheter 3001 can be configured not to bend and / or flex while in the compressed form shown in image 3000a. For example, a driving pressure can be applied to the catheter 3001 without the catheter 3001 and / or the bent portion of the catheter 3001 bending.

[0243] In some implementations, at step 2904, method / process 2900 involves releasing the wire tension of one or more pull wires 3030 of catheter 3001 to allow at least partial expansion of catheter 3001, as shown in image 3000b of FIG. 30. For example, catheter 3001 and / or the bent portion of catheter 3001 may bend in response to the release of wire tension.

[0244] In some implementations, at step 2906, method / process 2900 involves maintaining contact between catheter 3001 and / or the bent portion and / or distal end of catheter 3001 and anchor 3005, as illustrated in image 3000c of FIG. 30, to evaluate the retention and / or fixation of anchor 3005 to native tissue and / or valve tip 3003. For example, catheter 3001 and / or the distal end of catheter 3001 may be configured to move with anchor 3005, artificial valve tip 3003, and / or tissue 10 while maintaining contact between catheter 3001 and anchor 3005.

[0245] If it is determined that the fixation of anchor 3005 is incomplete, catheter 3001 and / or the bent portion of catheter 3001 may advantageously be compressed and / or tensioned to allow further driving of anchor 3005 without the need to reattach catheter 3001 to anchor 3005. For example, one or more pull wires 3030 may be flexible and / or in a non-tensioned state to allow movement of catheter 3001, and / or may be tensioned to restore a compressed and / or rigid form of catheter 3001. In the flexible state, the bent portion of catheter 3001 may be configured to freely swing in response to the rhythm of an external force and / or in various directions (e.g., complex three-dimensional and / or circular movements).

[0246] If it is determined that the fixation of the anchor 3005 is sufficient, the catheter 3001 and / or the bent portion of the catheter 3001 can be removed from the anchor 3005 and / or can be moved to different locations to facilitate driving a second anchor into the artificial valve tip 3003, the tissue 10, and / or other target locations.

[0247] The catheter 3001 can be configured to selectively assume a rigid state and / or a flexible state to assist with various stages of delivery and / or anchor driving. The catheter 3001 can be configured for a transcatheter procedure. In some implementations, the catheter 3001 can be configured to facilitate navigation to the target location by assuming a flexible state and / or to facilitate driving by assuming a rigid state. Further, the catheter 3001 can be configured to again assume a flexible and / or soft state after driving one or more anchors and to continue driving one or more anchors after evaluation of one or more factors (e.g., mitral regurgitation) in response to the initial driving of the one or more anchors.

[0248] It can be advantageous to rapidly evaluate the placement and / or fixation of the anchor and / or implant after delivery. In some implementations, the systems, devices, apparatuses, methods, etc. herein advantageously enable rapid evaluation of one or more anchors and / or implants prior to removal of the delivery system. In some implementations, these advantageously enable adjustment of the delivered anchor and / or implant after and / or immediately after delivery and / or driving of the anchor and / or implant.

[0249] FIG. 31 (FIGS. 31-1 and 31-2) provides a flowchart illustrating an exemplary method or process 3100 for driving one or more tissue anchors and / or for evaluating the fixation of one or more tissue anchors according to one or more examples. FIG. 32 (FIGS. 30-1 and 30-2) provides images associated with exemplary steps of the process 3100 of FIG. 31.

[0250] In step 3102, exemplary method or process 3100 may involve delivering, driving, and / or securing one or more anchors, including a first anchor 3205, to a target tissue site, as shown in image 3200a of FIG. 32. The first anchor 3205 may be delivered via a delivery system comprising a catheter 3201 (e.g., an elongate shaft), an outer shaft 3204, and / or an inner shaft 3206. In some implementations, the catheter 3201 may be a steerable catheter 3201 and / or may be configured to bend and / or otherwise navigate an anatomical path. The catheter 3201 may comprise one or more pull wires configured to facilitate advancement and / or retraction of the outer shaft 3204 and / or the inner shaft 3206.

[0251] In some implementations, the first anchor 3205 may be oriented and / or positioned using the outer shaft 3204 and / or the inner shaft 3206. In some implementations, the outer shaft 3204 may be at least partially rigid. For example, the outer shaft 3204 may be at least partially resistant to bending. The outer shaft 3204 may be configured to provide sufficient rigidity and / or stiffness such that the outer shaft 3204 extends to enable driving and / or securing of the first anchor 3205. The outer shaft 3204 may have sufficient pushability and / or flexural rigidity to drive through the implant 3203 and / or native tissue. In some implementations, the outer shaft 3204 may comprise a braided polymer and / or a laser-cut hypotube.

[0252] In some embodiments, the inner shaft 3206 may be at least partially covered within the outer shaft 3204, and / or the outer shaft 3204 may be at least partially covered within the catheter 3201 during delivery. For example, the outer shaft 3204 may comprise an inner lumen sized to at least partially receive the inner shaft 3206 therearound, and / or the inner shaft 3206 may be sized and / or shaped to fit within the outer shaft 3204.

[0253] In some embodiments, the outer shaft 3204 extends beyond the distal end of the catheter 3201 during the orientation and / or placement of the first anchor 3205, such that the stiffness of the outer shaft 3204 enables facilitating the driving of the first anchor 3205.

[0254] In some embodiments, the inner shaft 3206 may be at least partially flexible. In some embodiments, the inner shaft 3206 may extend with the outer shaft 3204 during the driving and / or placement of the first anchor 3205. However, the outer shaft 3204 may be configured to at least partially prevent the bending and / or movement of the inner shaft 3206 during the driving and / or delivery of the first anchor 3205.

[0255] In some embodiments, the outer shaft 3204 and / or the catheter 3201 may not be directly coupled to the first anchor 3205. For example, the inner shaft 3206 may be configured to couple to the first anchor 3205 at the distal end of the inner shaft 3206. Thus, the extension of the inner shaft 3206 may cause a corresponding extension of the first anchor 3205 toward the implant 3203. The inner shaft 3206 and the outer shaft 3204 may extend together and / or separately. For example, the extension of the outer shaft 3204 may be configured to cause a corresponding extension of the inner shaft 3206, and / or the extension of the inner shaft 3206 may be configured to cause a corresponding extension of the outer shaft 3204. However, in some embodiments, the outer shaft 3204 and the inner shaft 3206 may extend separately and / or via separate drive components.

[0256] In step 3104, the process 3100 may involve at least partially retracting the outer shaft 3204 and / or at least partially exposing the distal portion of the inner shaft 3206, as shown in image 3200b of FIG. 32. Retraction of the outer shaft 3204 may involve further pulling the outer shaft 3204 into the catheter 3201 and / or pulling it away from the first anchor 3205.

[0257] In some embodiments, the outer shaft 3204 may retract when the first anchor 3205 is at least partially driven, anchored, positioned, and / or secured to the implant 3203 and / or the anatomical structure under the implant 3203. Retraction of the outer shaft 3204 may result in the exposure of the inner shaft 3206.

[0258] In some implementations, the inner shaft 3206 can have a substantially flexible structure and / or can be configured to bend in response to pressure on the inner shaft 3206. In some implementations, the inner shaft 3206 can comprise a laser cut hypo tube and / or can comprise one or more features configured to enhance the flexibility of the inner shaft 3206. For example, the inner shaft 3206 can generally have a thin structure and / or can be thinner relative to the outer shaft 3204. In some implementations, the inner shaft 3206 can comprise one or more cavities 3208 (e.g., openings, slits, apertures, holes, grooves, etc.) configured to improve the flexibility of the inner shaft 3206. The one or more cavities 3208 can extend completely and / or partially through the wall of the inner shaft 3206. For example, the one or more cavities 3208 can provide an opening into the inner lumen of the inner shaft 3206. However, the one or more cavities can comprise grooves that are partially cut out from the wall of the inner shaft 3206.

[0259] In some implementations, the inner shaft 3206 can be configured to bend in multiple directions. For example, the inner shaft 3206 can be configured to bend in a substantially wavy and / or oscillatory pattern. Accordingly, the inner shaft 3206 can comprise cavities 3208 on multiple sides and / or along a substantial length of the inner shaft 3206 (e.g., along the entire inner shaft 3206).

[0260] In some implementations, the inner shaft 3206 may or may not comprise cavities 3208 on one or more sides of the inner shaft 3206.

[0261] In some implementations, the inner shaft 3206 can comprise cavities 3208 only at the distal end of the inner shaft 3206 and / or not along the entire length of the inner shaft 3206.

[0262] The inner shaft 3206 is illustrated as a tube having a solid circumferential wall, but the inner shaft 3206 may have a different form. For example, the inner shaft 3206 may comprise a coil and / or a coiled wire and / or a line. In some implementations, the inner shaft 3206 may comprise an expandable tube and / or balloon configured to be pressurized and / or depressurized with one or more gases and / or fluids.

[0263] In some implementations, the inner shaft 3206 may be configured to maintain contact with the first anchor 3205 after the outer shaft 3204 retracts. For example, the inner shaft 3206 may be coupled to the first anchor 3205 and / or configured to grip the first anchor 3205 and / or maintain a grip on the first anchor 3205 after the outer shaft 3204 retracts.

[0264] In step 3106, the method / process 3100 may involve advancing the inner shaft 3206 at least partially beyond the outer shaft 3204 and / or the catheter 3201, as shown in the image 3200c of FIG. 32, to create sagging and / or facilitate bending of the inner shaft 3206. As the inner shaft 3206 advances, the catheter 3201 and / or the outer shaft 3204 may remain in place. Accordingly, the distance between the first anchor 3205 and the outer shaft 3204 may be kept constant. As the inner shaft 3206 advances, a greater amount of the inner shaft 3206 may be extended and / or may fill the space between the outer shaft 3204 and the first anchor 3205.

[0265] In some embodiments, the inner shaft 3206 can be configured to naturally bend into a bent and / or wavy configuration to allow the distal portion of the inner shaft 3206 to cover a smaller distance and / or space. In some embodiments, the inner shaft 3206 and / or the outer shaft 3204 can be configured to advance and / or retract independently of each other. For example, the advancement and / or retraction of the outer shaft 3204 may not cause a corresponding advancement and / or retraction of the inner shaft 3206.

[0266] In some embodiments, advancing the inner shaft 3206 can be configured to reduce the load on the inner shaft 3206 from the first anchor 3205 and / or create sag in the inner shaft 3206. For example, the bending and / or sagging of the inner shaft 3206 can reduce the pulling force from the distal end of the inner shaft 3206 on the first anchor 3205. In the advanced state, the distal end of the inner shaft 3206 can be configured to loosely grip the first anchor 3205 and / or allow for a maximum amount of natural movement of the tissue anchor 3205 and / or the implant 3203 in response to tissue movement.

[0267] In some embodiments, the inner shaft 3206 can be at least partially expandable and / or compressible. For example, the inner shaft 3206 can be configured to expand with gas and / or fluid during delivery to facilitate gripping and / or driving of the first anchor 3205. The gas and / or fluid can be drawn from the inner shaft 3206 and / or the inner shaft 3206 can be decompressed before or after the retraction of the outer shaft 3204 to soften and / or increase the flexibility of the inner shaft 3206.

[0268] In the flexible state, the inner shaft 3206 can be configured to freely oscillate in response to the rhythm of an external force and / or in various (e.g., multiple) directions (e.g., complex three-dimensional and / or circular movements).

[0269] In step 3108, method / process 3100 may involve evaluating the fixation and / or placement of implant 3203 and / or first anchor 3205 with respect to a slack and / or loose inner shaft 3206. A slack inner shaft 3206 may allow movement of anchor 3205 and / or implant 3203. Thus, the first anchor 3205 and / or implant 3203 may be visualized while the inner shaft 3206 is in a slack state to determine whether the first anchor 3205 and / or implant 3203 move naturally and / or in a desired manner.

[0270] Any suitable imaging means may be used to evaluate the placement and / or fixation of the first anchor 3205 and / or additional anchors and / or implant 3203. For example, echo and / or fluorescence imaging may be utilized for the evaluation of the anchor and / or implant 3203. Although process 3100 has been described with respect to the placement of only the first anchor 3205, additional anchors may be delivered, evaluated, and / or fixed in a similar manner.

[0271] If it is determined that the fixation of the anchor 3205 is incomplete, the inner shaft 3206 may advantageously be at least partially retracted (or pressurized), and / or the outer shaft 3204 may advantageously be advanced to allow further driving of the anchor 3205 without the need to reattach the inner shaft 3206 to the anchor 3205.

[0272] If it is determined that the fixation of the anchor 3205 is sufficient, the catheter 3201, outer shaft 3204, and / or inner shaft 3206 may be removed from the anchor 3205 and / or moved to a different location to facilitate driving a second anchor into the prosthetic valve tip 3203, tissue 10, and / or other target location.

[0273] In some implementations, the outer shaft 3204 can be advanced to continue driving one or more anchors after evaluation of one or more factors (e.g., mitral regurgitation) in response to initial driving of the one or more anchors.

[0274] In some implementations, multiple anchors can be implanted and / or evaluated simultaneously.

[0275] Some implementations are systems for evaluating fixation of one or more tissue anchors, including an outer shaft that includes an inner lumen, and an inner shaft that at least partially fits within the inner lumen of the outer shaft and is configured to drive one or more tissue anchors, the inner shaft having a generally flexible structure relative to the outer shaft.

[0276] In some implementations, the techniques described herein relate to a system, and the inner shaft includes one or more cavities configured to improve the flexibility of the inner shaft.

[0277] In some implementations, the techniques described herein relate to a system, and the outer shaft is configured to advance and retract independently of the inner shaft.

[0278] According to some implementations of the present disclosure, a method for evaluating fixation of one or more tissue anchors includes delivering an outer shaft and an inner shaft to a target tissue location, the outer shaft at least partially surrounding the inner shaft.

[0279] In some implementations, the method further includes attaching the inner shaft to a tissue anchor.

[0280] In some implementations, the method further includes retracting the outer shaft to expose a distal portion of the inner shaft.

[0281] In some implementations, the method further includes advancing the inner shaft to create a slack in a distal portion of the inner shaft.

[0282] In some implementations, the method further includes evaluating the tissue anchor using the inner shaft attached to the tissue anchor.

[0283] In some implementations, the method further includes advancing the outer shaft to drive the tissue anchor into the tissue.

[0284] In some implementations, the inner shaft is substantially flexible relative to the outer shaft. In some implementations, the inner shaft includes one or more cavities configured to improve the flexibility of the inner shaft.

[0285] In some implementations, the outer shaft is configured to advance and retract independently of the inner shaft.

[0286] In some implementations, the method further includes removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is suitably fixed.

[0287] In some implementations, advancing the inner shaft to create a slack in the distal portion of the inner shaft involves enabling the distal portion of the inner shaft to bend in multiple directions.

[0288] In some implementations, the method further includes removing the inner shaft from the tissue anchor.

[0289] In some implementations, the method further includes attaching the inner shaft to a second tissue anchor. In some implementations, the method further includes retracting the outer shaft to expose the distal portion of the inner shaft.

[0290] In some embodiments, the method further includes advancing the inner shaft to create slack in a distal portion of the inner shaft.

[0291] In some embodiments, the method further includes evaluating a second tissue anchor using an inner shaft attached to the second tissue anchor.

[0292] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, cadaver heart, virtual human, simulator, etc.). In a simulation, body parts can optionally be referred to as a "simulation" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, computerized representations and / or physical representations.

[0293] According to some embodiments of the present disclosure, a method for delivering one or more tissue anchors includes delivering a slender shaft carrying the one or more tissue anchors at a distal end of the slender shaft to a target tissue location.

[0294] In some embodiments, the slender shaft comprises a bend configured to move between a first state and a second state.

[0295] In some embodiments, the method may further include driving the one or more tissue anchors into the target tissue location and moving the bend from the first state to the second state to facilitate moving the bend from the second state to the first state.

[0296] In some embodiments, moving the bend from the first state to the second state may involve compressing the bend.

[0297] In some embodiments, moving the bend from the first state to the second state involves twisting the slender shaft until a gap is formed in the bend.

[0298] In some embodiments, the flexure portion comprises at least one removable tab between segments of the flexure portion. The segments can be in a ring shape.

[0299] In some embodiments, the flexure portion can comprise an interlocking network of teeth. In some embodiments, the flexure portion comprises a coil extending through the lumen of the flexure portion.

[0300] In some embodiments, the coil is configured to interconnect segments of the flexure portion. In some embodiments, the flexure portion can comprise a cutout through an elongate shaft.

[0301] In some embodiments, moving the flexure portion from a first state to a second state involves pulling one or more pull wires extending at least partially through the flexure portion.

[0302] In some embodiments, the flexure portion includes two or more segments. In some embodiments, one or more pull wires interconnect the two or more segments.

[0303] In some embodiments, moving the flexure portion from a second state to a first state involves releasing one or more pull wires.

[0304] In some embodiments, in response to determining that a first tissue anchor is not suitably fixed, the method further includes moving the flexure portion from a first state to a second state to facilitate driving the first tissue anchor further into a target tissue location.

[0305] In some embodiments, in response to determining that a first tissue anchor is suitably fixed, the method includes removing the flexure portion from the first tissue anchor.

[0306] In some implementations, the method further includes facilitating moving a first tissue anchor from a first state to a second state and driving a second tissue anchor within a second target tissue location.

[0307] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, body parts can optionally be referred to as "simulations" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, computerized representations and / or physical representations.

[0308] In some implementations, a system for delivering one or more tissue anchors includes an elongate shaft configured to carry one or more tissue anchors to a target tissue location at a distal end of the elongate shaft. In some implementations, the elongate shaft includes a bend configured to move between a first state and a second state.

[0309] In some implementations, the system further includes an inner shaft configured to extend at least partially through a lumen of the elongate shaft. In some implementations, the system may further include an outer shaft configured to at least partially surround the elongate shaft.

[0310] In some implementations, the bend can be configured to move from the first state to the second state by compressing the bend.

[0311] In some implementations, the bend is configured to form a gap in response to a torsional rotation of the elongate shaft.

[0312] In some implementations, the bend includes at least one removable tab between segments of the bend. The segments can be ring-shaped.

[0313] In some embodiments, the flexure may comprise an interconnected network of teeth. In some embodiments, the flexure comprises a coil extending through the lumen of the flexure.

[0314] In some embodiments, the coil is configured to interconnect segments of the flexure. The flexure may comprise a cutout through an elongate shaft.

[0315] In some embodiments, the system may further comprise one or more pull wires configured to extend at least partially through the flexure. In some embodiments, the one or more pull wires extend at least partially through a plurality of segments of the flexure.

[0316] Any of the various systems, assemblies, devices, instruments, etc. in the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by a patient, and the methods herein may include (or additional methods may include or consist of) sterilization of the associated systems, devices, instruments, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0317] Additional Explanation of Examples A list of examples is provided below, each of which may include aspects of any of the other examples disclosed herein. Further, aspects of any of the above examples may be implemented in any of the numbered examples provided below.

[0318] Depending on the example, any particular action, event, or function of any of the processes or algorithms described herein may be performed in a different order, may be added, may be combined, or may be completely excluded. Thus, in a particular example, not all of the described actions or events are necessary for the practice of the process.

[0319] Some embodiments of the present disclosure relate to various examples including the following.

[0320] Example 1: A system for evaluating the fixation of one or more tissue anchors, the system comprising: an outer shaft having an inner lumen; and an inner shaft at least partially received within the inner lumen of the outer shaft and configured to drive one or more tissue anchors, the inner shaft having a substantially flexible structure relative to the outer shaft.

[0321] Example 2: Any example herein, particularly the system of Example 1, wherein the inner shaft comprises one or more cavities configured to improve the flexibility of the inner shaft.

[0322] Example 3: Any example herein, particularly the systems of Examples 1-2, wherein the outer shaft is configured to advance and retract independently of the inner shaft.

[0323] Example 4: A method for evaluating the fixation of one or more tissue anchors, the method comprising: delivering an outer shaft and an inner shaft to a target tissue location, the outer shaft at least partially surrounding the inner shaft; attaching the inner shaft to a tissue anchor; retracting the outer shaft to expose a distal portion of the inner shaft; advancing the inner shaft to create slack in the distal portion of the inner shaft; and evaluating the tissue anchor using the inner shaft attached to the tissue anchor.

[0324] Example 5: Any example herein, particularly the method of Example 4, further comprising advancing the outer shaft to drive the tissue anchor into the tissue.

[0325] Example 6: Any example herein, particularly the methods of Examples 4-5, wherein the inner shaft is substantially flexible relative to the outer shaft.

[0326] Example 7: Any example herein, particularly the method of Example 6, wherein the inner shaft comprises one or more cavities configured to improve the flexibility of the inner shaft.

[0327] Example 8: The method of any example herein, particularly the methods of Examples 4-7, wherein the outer shaft is configured to advance and retract independently of the inner shaft.

[0328] Example 9: The method of any example herein, particularly the methods of Examples 4-8, further comprising removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is suitably fixed.

[0329] Example 10: The method of any example herein, particularly the methods of Examples 4-9, wherein the inner shaft comprises one or more cavities configured to improve the flexibility of the inner shaft.

[0330] Example 11: The method of any example herein, particularly the methods of Examples 4-10, wherein the outer shaft is configured to advance and retract independently of the inner shaft.

[0331] Example 12: The method of any example herein, particularly the methods of Examples 4-11, wherein advancing the inner shaft to create a sag in the distal portion of the inner shaft allows the distal portion of the inner shaft to bend in multiple directions.

[0332] Example 13: The method of any example herein, particularly the methods of Examples 4-12, further comprising removing the inner shaft from the tissue anchor, attaching the inner shaft to a second tissue anchor, retracting the outer shaft to expose the distal portion of the inner shaft, advancing the inner shaft to create a sag in the distal portion of the inner shaft, and evaluating the second tissue anchor using the inner shaft attached to the second tissue anchor.

[0333] Example 14: A method for delivering one or more tissue anchors, the method comprising delivering an elongate shaft to a target tissue location, the elongate shaft comprising a flexure portion configured to move between a first state and a second state; moving the flexure portion from the first state to the second state to facilitate driving a first tissue anchor into the target tissue location; and moving the flexure portion from the second state to the first state while maintaining contact between the flexure portion and the first tissue anchor.

[0334] Example 15: The method of any example herein, particularly the method of Example 14, wherein the elongate shaft is configured to carry one or more tissue anchors at a distal end of the elongate shaft.

[0335] Example 16: The method of any example herein, particularly the method of Examples 14 - 15, wherein moving the flexure portion from the first state to the second state involves compressing the flexure portion.

[0336] Example 17: The method of any example herein, particularly the method of Examples 14 - 16, wherein the flexure portion includes two or more segments.

[0337] Example 18: The method of any example herein, particularly the method of Example 17, wherein the segments are ring-shaped.

[0338] Example 19: The method of any example herein, particularly the method of Example 17, wherein moving the flexure portion from the first state to the second state involves pulling one or more pull wires that extend at least partially through two or more segments.

[0339] Example 20: The method of any example herein, particularly the method of Example 19, wherein one or more pull wires interconnect two or more segments.

[0340] Example 21: The method of any example herein, particularly the method of Example 19, wherein moving the flexure portion from the second state to the first state involves releasing one or more pull wires.

[0341] Example 22: In response to determining that the first tissue anchor is not suitably fixed, further including moving the flexure portion from the first state to the second state to facilitate further driving the first tissue anchor into the target tissue location, any example herein, particularly the methods of Examples 14-21.

[0342] Example 23: In response to determining that the first tissue anchor is suitably fixed, further including removing the flexure portion from the first tissue anchor, any example herein, particularly the methods of Examples 14-22.

[0343] Example 24: Further including moving the first tissue anchor from the first state to the second state to facilitate driving the second tissue anchor into the second target tissue location, any example herein, particularly the method of Example 23.

[0344] Example 25: A system for delivering one or more tissue anchors, the system comprising a handle, a threaded screw coupled to the handle, a knob, an outer shaft coupled to the knob, and a bolt configured to twist and rotate along the threaded screw and press against the knob.

[0345] Example 26: Any example herein, particularly the system of Example 25, further comprising an inner shaft configured to extend at least partially through the knob and the threaded screw.

[0346] Example 27: Any example herein, particularly the system of Example 26, further comprising a peg extending from the inner shaft.

[0347] Example 28: Any example herein, particularly the system of Example 27, wherein the knob comprises a channel configured to receive the peg.

[0348] Example 29: Any example herein, particularly the system of Example 28, wherein the peg is configured to prevent rotation of the knob.

[0349] Example 30: Any example of the present specification, particularly the systems of Examples 25 to 29, further comprising an arm coupled to the bolt, the arm being configured to press against or pull on a protrusion extending from the outer surface of the knob.

[0350] Example 31: Any example of the present specification, particularly the systems of Examples 25 to 30, further comprising a stopper nut disposed along a threaded screw and between the bolt and the handle.

[0351] Example 32: Any example of the present specification, particularly the systems of Examples 25 to 31, further comprising a washer disposed between the knob and the bolt.

[0352] Example 33: Any example of the present specification, particularly the systems of Examples 25 to 32, wherein the knob is configured not to torsionally rotate in response to a force from the bolt.

[0353] In particular, conditional language used in this specification such as "can", "could", "might", "may", "for example (e.g.)", etc. is intended in its ordinary sense and, unless otherwise specified or understood differently within the context in which it is used, and it is generally intended to convey that a particular implementation form includes certain features, elements, and / or steps, while other implementation forms do not. Thus, such conditional language is generally not intended to mean that features, elements, and / or steps are necessary in some way for one or more implementation forms, or to determine whether these features, elements, and / or steps are included in any particular implementation form, or whether they should be performed in any particular implementation form, regardless of the author's input or the presence of prompts, and that one or more implementation forms necessarily include the logic for this. Terms such as "comprising", "including", "having", etc. are synonymous and are used in their ordinary sense, in an inclusive and non-limiting manner, and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive sense (and not in its exclusive sense) when used, for example, to connect a list of elements, such that the term "or" means one, some, or all of the elements in the list. Connective language such as the phrase "at least one of X, Y, and Z" is understood in the context as being generally used to convey that items, terms, elements, etc. can be any of X, Y, or Z, unless otherwise specified. Thus, such connective language is generally not intended to imply that a particular implementation form requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0354] In the above description of the implementation forms, for the purpose of rationalizing the present disclosure and assisting in the understanding of one or more aspects of various inventions, it should be understood that various features are sometimes grouped together in a single implementation form, figure, or its description. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than are explicitly recited in that claim. Moreover, any component, feature, or step exemplified and / or described in a particular example herein can be applied to, or used in conjunction with, any other implementation form. Furthermore, there are no components, features, steps, or groups of components, features, or steps that are necessarily required or indispensable for each implementation form. Therefore, the scope of the invention of this specification disclosed and claimed below is not intended to be limited by the specific implementation forms described above, but rather is intended to be determined only by a fair reading of the following claims.

[0355] It should be understood that specific ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply a physical characteristic or order. Thus, as used herein, ordinal terms (e.g., "first", "second", "third", etc.) used to modify elements such as structures, components, operations, etc. do not necessarily indicate a priority or order of the element with respect to any other element, but rather generally distinguish (except for the use of ordinal terms) the element from another element having a similar or identical name. In addition, when used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one". Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0356] Unless otherwise defined, all terms (including technical and scientific terms) used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary implementations belong. Further, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0357] Spatially relative terms, such as "outer", "inner", "upper", "lower", "below", "above", "vertical", "horizontal", and the like, may be used herein for ease of explanation to describe the relationship between one element or component and another as shown in the drawings. It is understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device shown in the drawings is turned over, a device positioned "below" or "beneath" another device may be positioned "above" the other device. Thus, the exemplary term "below" may include both a lower and an upper position. The device may also be oriented in other directions, and thus, spatially relative terms may be interpreted differently depending on the orientation.

[0358] Unless explicitly stated otherwise, comparative terms and / or quantitative terms, such as "less", "more", "greater", and the like, are intended to encompass equivalent concepts. For example, "less" may mean not only "less" in the strictest mathematical sense, but also "less than or equal to".

Claims

**Claim 1** A system for evaluating the fixation of one or more tissue anchors, the system comprising: an outer shaft having an inner lumen; an inner shaft at least partially received within the inner lumen of the outer shaft and configured to drive one or more tissue anchors, the inner shaft having a generally flexible structure relative to the outer shaft. **Claim 2** The system of claim 1, wherein the inner shaft comprises one or more cavities configured to improve the flexibility of the inner shaft. **Claim 3** The system of claim 1 or 2, wherein the outer shaft is configured to advance and retract independently of the inner shaft. **Claim 4** A method for evaluating the fixation of one or more tissue anchors, the method comprising: delivering an outer shaft and an inner shaft to a target tissue location, the outer shaft at least partially surrounding the inner shaft; attaching the inner shaft to a tissue anchor; retracting the outer shaft to expose a distal portion of the inner shaft; advancing the inner shaft to create slack in the distal portion of the inner shaft; and evaluating the tissue anchor using the inner shaft attached to the tissue anchor. **Claim 5** The method of claim 4, further comprising advancing the outer shaft to drive the tissue anchor into the tissue. **Claim 6** The method of claim 4 or 5, wherein the inner shaft is generally flexible relative to the outer shaft. **Claim 7** The method of claim 6, wherein the inner shaft comprises one or more cavities configured to improve the flexibility of the inner shaft. **Claim 8** The method of any one of claims 4-7, wherein the outer shaft is configured to advance and retract independently of the inner shaft. **Claim 9** The method of any one of claims 4-8, further comprising removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is suitably fixed. **Claim 10** The method of any one of claims 4-9, wherein the inner shaft comprises one or more cavities configured to improve the flexibility of the inner shaft. **Claim 11** The method according to any one of claims 4 to 10, wherein the outer shaft is configured to move forward and backward independently of the inner shaft.

12. Advancing the inner shaft to create slack in the distal portion of the inner shaft involves enabling the distal portion of the inner shaft to bend in multiple directions, the method according to any one of claims 4 to 11.

13. Removing the inner shaft from the tissue anchor, Attaching the inner shaft to a second tissue anchor, Retracting the outer shaft to expose the distal portion of the inner shaft, Advancing the inner shaft to create slack in the distal portion of the inner shaft, Further comprising evaluating the second tissue anchor using the inner shaft attached to the second tissue anchor, the method according to any one of claims 4 to 12.

14. A method for delivering one or more tissue anchors, the method comprising: Delivering an elongate shaft to a target tissue location, the elongate shaft comprising a flexure portion configured to move between a first state and a second state; Moving the flexure portion from the first state to the second state to facilitate driving a first tissue anchor into the target tissue location; Moving the flexure portion from the second state to the first state while maintaining contact between the flexure portion and the first tissue anchor.

15. The method according to claim 14, wherein the elongate shaft is configured to carry one or more tissue anchors at a distal end of the elongate shaft.

16. The method according to claim 14 or 15, wherein moving the flexure portion from the first state to the second state involves compressing the flexure portion.

17. The method according to any one of claims 14 to 16, wherein the flexure portion comprises two or more segments.

18. The method according to claim 17, wherein the segments are ring-shaped.

19. The method according to claim 17, wherein moving the flexure portion from the first state to the second state involves pulling one or more pull wires extending at least partially through the two or more segments.

20. The method of claim 19, wherein moving the bent portion from the second state to the first state involves releasing the one or more pull wires. **Claim 21** The method according to any one of claims 14 to 20, further comprising moving the bent portion from the first state to the second state in response to determining that the first tissue anchor is not properly fixed, to facilitate further driving the first tissue anchor into the target tissue location. **Claim 22** The method according to any one of claims 14 to 21, further comprising removing the bent portion from the first tissue anchor in response to determining that the first tissue anchor is properly fixed. **Claim 23** The method of claim 22, further comprising moving the first tissue anchor from the first state to the second state to facilitate driving a second tissue anchor into a second target tissue location. **Claim 24** A system for delivering one or more tissue anchors, the system comprising a handle, a threaded screw coupled to the handle, a knob, an outer shaft coupled to the knob, and a bolt configured to twist and rotate along the threaded screw and press against the knob. **Claim 25** The system of claim 24, further comprising an inner shaft configured to extend at least partially through the knob and the threaded screw. **Claim 26** The system of claim 25, further comprising a peg extending from the inner shaft. **Claim 27** The system of claim 26, wherein the knob comprises a channel configured to receive the peg and / or the peg is configured to prevent rotation of the knob. **Claim 28** The system according to any one of claims 24 to 27, further comprising an arm coupled to the bolt, the arm being configured to press against or pull on a protrusion extending from an outer surface of the knob. **Claim 29** The system according to any one of claims 24 to 28, further comprising a stopper nut disposed along the threaded screw and between the bolt and the handle. **Claim 30** The system according to any one of claims 24 to 29, wherein the knob is configured not to torsionally rotate in response to the force from the bolt.

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