Anchor delivery and evaluation system

Abstract

Systems and methods for evaluating anchoring of one or more tissue anchors, the system including an outer shaft including an inner lumen and an inner shaft configured to fit at least partially within the inner lumen of the outer shaft and drive one or more tissue anchors, where the inner shaft has a generally flexible structure relative to the outer shaft. Other embodiments are also described.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 366,713, entitled “ANCHOR DRIVERS,” filed on June 21, 2022, U.S. Provisional Patent Application Serial No. 63 / 415,595, entitled “ANCHOR DELIVERY SYSTEMS,” filed on October 12, 2022, and U.S. Provisional Patent Application Serial No. 63 / 489,147, entitled “ANCHOR DELIVERY ANDASSESSMENT SYSTEMS,” filed on March 8, 2023, the entire disclosures of which are hereby incorporated by reference herein in their entirety. Background Art

[0003] Annuloplasty generally involves reshaping the tissue of a native heart valve annulus. Annuloplasty can be performed by pulling the tissue surrounding the annulus to a new shape. Tensioning wires / threads connected to tissue anchors and / or other implanted devices can be used to facilitate medical procedures such as annuloplasty or other reshaping procedures. Summary of the invention

[0004] Described herein is one or more methods and / or devices for delivering, actuating, and / or assessing placement and / or anchoring of one or more tissue anchors.

[0005] Some embodiments of the present disclosure relate to a system for evaluating the anchoring of one or more tissue anchors, the system comprising an outer shaft and an inner shaft, the outer shaft comprising an inner lumen, the inner shaft being configured to at least partially fit within the inner lumen of the outer shaft and drive one or more tissue anchors, wherein the inner shaft has a substantially flexible structure relative to the outer shaft.

[0006] In some implementations, the technology described herein relates to a system wherein the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

[0007] In some implementations, the technology described herein relates to a system in which an outer shaft is configured to be advanced and retracted independently of an inner shaft.

[0008] According to some embodiments of the present disclosure, a method for assessing anchoring 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.

[0009] In some embodiments, the method further comprises attaching the inner shaft to the tissue anchor.

[0010] In some embodiments, the method further comprises retracting the outer shaft to expose a distal portion of the inner shaft.

[0011] In some embodiments, the method further comprises advancing the inner shaft to create slack in a distal portion of the inner shaft.

[0012] In some embodiments, the method further comprises evaluating the tissue anchor with the inner shaft attached to the tissue anchor.

[0013] In some embodiments, the method further comprises advancing the outer shaft to drive the tissue anchor into the tissue.

[0014] In some embodiments, the inner shaft is substantially flexible relative to the outer shaft. In some embodiments, the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

[0015] In some embodiments, the outer shaft is configured to be advanced and retracted independently of the inner shaft.

[0016] In some embodiments, the method further comprises removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is properly anchored.

[0017] In some embodiments, advancing the inner shaft to create slack in the distal portion of the inner shaft includes allowing the distal portion of the inner shaft to flex in a plurality of directions.

[0018] In some embodiments, the method further comprises detaching the inner shaft from the tissue anchor.

[0019] In some embodiments, the method further comprises attaching the inner shaft to a second tissue anchor. In some embodiments, the method further comprises retracting the outer shaft to expose a distal portion of the inner shaft.

[0020] In some embodiments, the method further comprises advancing the inner shaft to create slack in a distal portion of the inner shaft.

[0021] In some embodiments, the method further includes evaluating the second tissue anchor with the inner shaft attached to the second tissue anchor.

[0022] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0023] According to some embodiments of the present disclosure, a method for delivering one or more tissue anchors includes delivering an elongated shaft carrying the one or more tissue anchors at a distal end of the elongated shaft to a target tissue location.

[0024] In some embodiments, the elongated shaft includes a flexure configured to move between a first state and a second state.

[0025] In some embodiments, the method can further include moving the flexure portion from the first state to the second state to facilitate driving the one or more tissue anchors into the target tissue location, and moving the flexure portion from the second state to the first state.

[0026] In some embodiments, moving the flexure from the first state to the second state may include compressing the flexure.

[0027] In some embodiments, moving the flexure from the first state to the second state includes twisting the elongated shaft until a gap is formed in the flexure.

[0028] In some embodiments, the flexure comprises at least one detachable tab between segments of the flexure.The segments may be annular.

[0029] In some embodiments, the flexure can include a network of interlocking teeth. In some embodiments, the flexure can include a coil extending through a lumen of the flexure.

[0030] In some embodiments, the coil is configured to interconnect segments of the flexure. In some embodiments, the flexure can include a cutout through the elongated shaft.

[0031] In some embodiments, moving the flexure portion from the first state to the second state includes pulling one or more pull wires extending at least partially through the flexure portion.

[0032] In some embodiments, the flexure comprises two or more segments. In some embodiments, one or more pull wires interconnect the two or more segments.

[0033] In some embodiments, moving the flexure from the second state to the first state includes releasing one or more pull wires.

[0034] In some embodiments, in response to determining that the first tissue anchor is not properly anchored, the method includes moving the flexure portion from the first state to the second state to facilitate driving the first tissue anchor further into the target tissue location.

[0035] In some embodiments, in response to determining that the first tissue anchor is properly anchored, the method includes removing the flexure from the first tissue anchor.

[0036] In some embodiments, the method further includes 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.

[0037] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0038] In some embodiments, a system for delivering one or more tissue anchors includes an elongated shaft carrying one or more tissue anchors at its distal end to a target tissue location. In some embodiments, the elongated shaft includes a flexure configured to move between a first state and a second state.

[0039] In some embodiments, the system further comprises an inner shaft configured to extend at least partially through the lumen of the elongated shaft. In some embodiments, the system may further comprise an outer shaft configured to at least partially surround the elongated shaft.

[0040] In some embodiments, the flexure can be configured to move from the first state to the second state by compressing the flexure.

[0041] In some embodiments, the flexure is configured to form a gap in response to torsion of the elongated shaft.

[0042] In some embodiments, the flexure comprises at least one detachable tab between segments of the flexure.The segments may be annular.

[0043] In some embodiments, the flexure can include a network of interlocking teeth. In some embodiments, the flexure can include a coil extending through a lumen of the flexure.

[0044] In some embodiments, the coil is configured to interconnect segments of the flexure.The flexure may include a cutout through the elongated shaft.

[0045] In some embodiments, the system may further include one or more pull wires configured to extend at least partially through the flexure portion. In some embodiments, the one or more pull wires extend at least partially through multiple sections of the flexure portion.

[0046] Any of the various systems, components, devices, equipment, 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 patients, and the methods herein may include (or the additional methods include or consist of) sterilization of the relevant systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0047] To summarize the present disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all of these advantages may be achieved according to any particular embodiment. Therefore, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or a group of advantages taught herein without necessarily achieving other advantages taught or suggested herein.

[0048] The methods and structures for treating patients disclosed herein also encompass similar methods and structures performed on or placed on simulated patients, which are suitable for, for example, training; demonstration; program 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 a simulation of all or part of a patient, for example, the entire body, a part of the body (e.g., chest), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. The physical element can be: natural, including a human or animal body or part thereof; synthetic; or any combination of natural and synthetic. The virtual element can be entirely in silica or covered on one or more of the physical components. The virtual element can be presented on any combination of a screen, earphones, holographic projections, speakers, headphones, pressure transducers, temperature transducers, or any combination using suitable technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] For the purpose of illustration, various embodiments are depicted in the accompanying drawings, and these embodiments should not be construed as limiting the scope of the present invention. In addition, the various features of the different disclosed embodiments can be combined to form additional embodiments as a part of the present disclosure. In all the accompanying drawings, reference numerals can be reused to represent the corresponding relationship between the reference elements.

[0050] Figure 1 Example representations of the heart and related anatomical structures having various features relevant to certain embodiments of the present disclosure are illustrated.

[0051] Figure 2 A top view of an annuloplasty implant system implanted in a native heart valve annulus is shown in accordance with one or more embodiments.

[0052] Figure 3An example implant system is illustrated in which one or more tissue anchors anchor annuloplasty tube to annuloplasty tissue of mitral valve 3 in accordance with one or more embodiments.

[0053] Figure 4 Example tissue anchors according to one or more implementations are illustrated.

[0054] Figure 5 Example delivery systems for delivering one or more tissue anchors to a target tissue site are illustrated in accordance with one or more embodiments.

[0055] Figure 6

[0013] Systems for delivering one or more tissue anchors into tissue in accordance with one or more embodiments are illustrated.

[0056] Figure 7 Anchoring one or more tissue anchors to tissue is illustrated in accordance with one or more embodiments.

[0057] Figure 8 The delivery of one or more tissue anchors into tissue 10 is illustrated in accordance with one or more embodiments.

[0058] Fig. 9 Delivering a delivery shaft into a chamber of the heart (eg, the right atrium) is illustrated in accordance with one or more embodiments.

[0059] Fig.10 Example flexible delivery shafts are illustrated that are configured for delivering one or more anchors at different portions of the anatomy, which may include at or around the tricuspid valve, the mitral valve, and / or other valves.

[0060] Fig.11 Example assemblies for driving one or more anchors into target tissue in accordance with one or more implementations are illustrated.

[0061] Fig.12 At least a portion of an assembly for delivering and / or driving one or more tissue anchors to a target tissue location is illustrated in accordance with one or more embodiments.

[0062] Fig.13 Example assemblies configured for delivering and / or driving various tissue anchors to a target tissue location are shown in accordance with one or more embodiments.

[0063] FIG. 14A to FIG. 14C Illustrated are example flexures of one or more shafts of a tissue anchor delivery assembly according to one or more embodiments described herein.

[0064] Fig.15Example flexures including one or more rings and / or one or more springs engaging the one or more rings are illustrated in accordance with one or more embodiments.

[0065] Fig.16 Example flexure sections including one or more loops and / or one or more cords and / or a network of cords engaging the one or more loops are illustrated in accordance with one or more embodiments.

[0066] Fig.17 At least a portion of an assembly including an example flexure portion including one or more rings and / or one or more springs engaging the one or more rings is illustrated according to one or more implementations.

[0067] Fig.18 At least a portion of an assembly including an example flexure including one or more segments including a first segment, a second segment, and / or a third segment according to one or more implementations is illustrated.

[0068] Fig.19 Example flexures including one or more interlocking teeth are illustrated in accordance with one or more embodiments.

[0069] Figure 20 Figure 20-1 and Figure 20-2 ) is a flow chart illustrating steps of an example process for delivering one or more tissue anchors via a shaft including a flexure portion according to one or more embodiments.

[0070] Figure 21 Figure 21-1 and Figure 21-2 ) provides example images corresponding to the steps of the process of Figure 20.

[0071] Fig.22A and Fig. 22B At least a portion of an example delivery shaft is illustrated that includes a flexure portion including one or more springs extending across a break in the delivery shaft in accordance with one or more embodiments.

[0072] Fig.23A and Fig. 23B

[00136] A process of driving one or more tissue anchors into tissue is illustrated in accordance with one or more embodiments.

[0073] Fig.24 An example shaft including a flexure according to one or more implementations is illustrated.

[0074] Fig.25A and Fig.25BExample delivery devices for delivering one or more catheters and / or medical devices to a target location within the body are illustrated in accordance with one or more embodiments.

[0075] Fig.26 Example flexures including one or more pull wires configured to control positioning of one or more loops and / or one or more springs engaging the one or more loops are illustrated in accordance with one or more embodiments.

[0076] FIG. 27A to FIG. 27C

[0013] Example compressible and / or adjustable anchor delivery systems configured for delivering one or more tissue anchors in accordance with one or more embodiments are illustrated.

[0077] FIG. 28A to FIG. 28D Example flexures of delivery catheters according to one or more embodiments are illustrated.

[0078] Figure 29 Figure 29-1 and Figure 29-2 ) provides a flowchart illustrating an example process for driving one or more tissue anchors and / or for evaluating anchoring of one or more tissue anchors according to one or more examples.

[0079] Figure 30 Figure 30-1 and Figure 30-2 ) provides images associated with the steps of the process of Figure 29.

[0080] Figure 31 Figure 31-1 and Figure 31-2 ) provides a flow chart illustrating an example method or process for driving one or more tissue anchors and / or for evaluating anchoring of one or more tissue anchors according to one or more embodiments.

[0081] Figure 32( Figure 30-1 and Figure 30-2 ) provides images associated with the steps of the process of Figure 31. DETAILED DESCRIPTION

[0082] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0083] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other optional embodiments and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the resulting claims is not limited to any specific embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any specific disclosed order. Various operations may be described as multiple discrete operations in a manner that helps to understand certain embodiments; however, the order of description should not be interpreted as implying that these operations are sequentially related. In addition, the therapeutic techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein may be performed on a living subject (e.g., a human, other animals, etc.) or on a non-living simulation such as a corpse, a corpse heart, a simulation body, a fictitious person, etc.). When performed on a simulation, a body part (e.g., a heart, tissue, a valve, etc.) may optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, simulated valve, etc.), and may include, for example, a computerized and / or physical representation of a body part, tissue, etc.

[0084] In addition, the structures, systems and / or devices described herein may be implemented as integrated components or independent components. In order to compare various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that realizes or optimizes one advantage or a group of advantages taught herein, without necessarily realizing other aspects or advantages also taught or suggested herein.

[0085] For the convenience of devices, components, systems, features and / or modules with possibly similar features in one or more aspects, certain reference numerals are reused in different figures of the group of figures of the present disclosure. However, with respect to any embodiment in the embodiments disclosed herein, the reuse of common reference numerals in the drawings does not necessarily indicate that these features, devices, components or modules are the same or similar. On the contrary, those of ordinary skill in the art can understand the degree of similarity between the referenced subjects by the context. The use of specific reference numerals in the context of the description of a specific figure can be understood as involving the identified device, component, aspect, feature, module or system in the specific figure, without having to involve any device, component, aspect, feature, module or system identified by the same reference numeral in another figure. In addition, the various aspects of the separate figures identified with common reference numerals can be interpreted as shared characteristics or completely independent of each other.

[0086] Some standard anatomical terms of position are used herein to refer to the anatomy of animals (i.e. humans) regarding preferred embodiments. Although some spatially relative terms, such as "external", "interior", "upper", "lower", "below", "above", "vertical", "horizontal", "top", "bottom" and similar terms, are used herein to describe the spatial relationship between a device / element or anatomical structure and another device / element or anatomical structure, it should be understood that for ease of description, these terms are used herein to describe the positional relationship between elements / structures, as shown in the figure. It should be understood that, in addition to the orientations depicted in the accompanying drawings, spatially relative terms are intended to cover the different orientations of elements / structures in use or operation. For example, an element / structure described as "above" another element / structure can represent a position below or beside such other elements / structures relative to an alternative orientation of a subject patient or element / structure, and vice versa.

[0087] Embodiments described herein relate to devices and / or methods for identifying and / or facilitating successful anchoring of one or more tissue anchors in a patient's body. Various devices for delivering implants (e.g., tissue anchors) to the heart and / or other anatomical structures may require forcing against structures within the heart and / or on the implant itself. In addition, the delivery path (e.g., femoral vein) for delivering devices and / or systems to reach the heart may include sharp tracks to, for example, the tricuspid and / or mitral valve annuli. Therefore, devices (e.g., shafts and / or catheters), particularly the distal portion of the devices, may need to be flexible and / or bendable to allow delivery through such tracks. These devices must also be able to convert vertical pressure to tighten cables and / or position and / or fix anchors delivered via the device. The implementation device may include various features that are configured to facilitate navigation to a target location and / or drive one or more tissue anchors at the target location.

[0088] In some embodiments, the anchor driver includes a flexure and / or at least partially separable shaft. The shaft may include two or more colinear portions, including a distal portion and a proximal portion. In some embodiments, the distal portion and the proximal portion may be at least partially removable and / or discontinuous. The anchor driver may include one or more connectors, which are configured to at least partially form an attachment between the distal portion and the proximal portion. In some embodiments, the connector may include a wire and / or coil extending from the distal portion to the proximal portion. One or more connectors may at least partially extend into the distal portion and / or the proximal portion and / or may be configured to extend across the gap and / or fracture between the distal portion and the proximal portion. In some embodiments, one or more connectors may be configured to maintain contact between the distal portion and the proximal portion via tension and / or mechanical function. One or more connectors may be configured to allow separation between the distal portion and the proximal portion in response to increased resistance at the distal portion and / or the proximal portion. For example, separation of the distal and proximal portions may occur when sufficient torque resistance is experienced at the distal and / or proximal portions and / or is identified fluoroscopically and / or electronically.

[0089] The shaft of the anchor driver may include a distal portion and a proximal portion that are at least partially disconnected, and the distal portion and the proximal portion may be at least partially colinear with each other in a default and / or static state. The spring-loaded wire may hold the two parts together via tension, and the surfaces of the two parts are usually flush with each other in a static and / or first state. The split line may be inclined and / or spiral. When subjected to sufficient torque resistance (e.g., because the anchor head has reached the tissue and / or anchoring is completed), continued rotation of the proximal portion may cause some separation of the proximal portion from the distal portion. The wire and / or coil may maintain the integrity of the driver, but the gap and / or offset generated may be detectable by fluoroscopic examination and / or electronic means. The spring constant of the spring-loaded 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 may be used to adjust the driver to split under a specific torque resistance.

[0090] Some embodiments relate to devices configured to be switchable between a flexible state and a substantially rigid state.The methods described herein provide for delivering a shaft in a flexible form and modifying the shaft to a substantially rigid rod and / or shaft configured for driving one or more anchors.

[0091] The shaft and / or catheter described herein can be used to deliver an anchor configured to straddle a wire and / or line. In some embodiments, when the desired number of anchors is placed, the wire can be tightened to determine the appropriate point to end the procedure. Due to the flexibility of some anchor drivers, it may be difficult for the anchor driver to allow tension to be applied to the wire (e.g., for anchoring inspection). The embodiments described herein can advantageously resist the tension associated with tightening to allow tightening at one or more points and / or fixing the anchor at a point along the wire. In some embodiments, the delivery system includes 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 embodiments, the shaft may be at least partially composed of nitinol and / or other shape memory alloy groups.

[0092] The present disclosure relates to anchoring devices, tensioning devices, systems and methods for anchoring and / or adjusting tension in silk or other lines, which can be connected to one or more tissue anchors or other implant devices. Such embodiments may include linear / axial actuation of one or more anchors and / or tensioning lines. The term "line" is used herein according to its broad and common meaning, and may refer to any elongated filament, tether, rope, strip, strand, suture, rope, filament, tether, string, ribbon, belt or a part thereof, or in a medical procedure for tethering, tightening, fixing, aligning, tying, maintaining or otherwise controlling / manipulating implant devices or components (e.g., tissue anchors) other types / forms of materials. In addition, embodiments of the present disclosure may be implemented in conjunction with non-surgical and / or non-biological line / wire tensioning. In addition, in some contexts herein, the terms "tether", "silk" and "line" may be used interchangeably. In addition, the use of the singular form of any line-related terms (including the terms "tether" and "silk") listed above may be used to refer to a single line / rope or a part thereof.

[0093] In some embodiments, the present disclosure relates to systems, devices and methods for driving and / or anchoring one or more tissue anchors associated with an implant device / assembly. The term "associated with..." is used herein according to its broad and common meaning. For example, when a first feature, element, part, device or member is described as being associated with a second feature, element, part, device or member, this description should be understood to indicate that the first feature, element, part, device or member is directly or indirectly physically connected, attached or connected, integrated, at least partially embedded therein or otherwise physically related to the second feature, element, part, device or member.

[0094] Certain embodiments are disclosed herein in the context of cardiac implant devices. However, although certain principles disclosed herein are particularly applicable to cardiac anatomy, it should be understood that tissue anchor-based implant devices according to the present disclosure may be implanted or configured for implantation in any suitable or desired anatomy.

[0095] The anatomical structure of the heart is described below to assist in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart typically includes a muscular organ having four blood-pumping chambers, wherein blood flow is at least partially controlled by various heart valves (i.e., the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve). The valves may be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to control the flow of blood to corresponding regions and / or blood vessels (e.g., the pulmonary artery, the aorta, etc.) of the heart. Contraction of the various myocardium may be facilitated by signals generated by the heart's electrical system, which will be discussed in detail below.

[0096] Figure 1 An example representation of a heart 1 and associated anatomical structures having various features relevant to certain embodiments disclosed herein is illustrated. In general, the heart 1 includes four chambers, namely a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. In terms of blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery via the pulmonary valve (not shown for clarity), which separates the right ventricle 4 from the pulmonary artery and is configured to open during systole so that blood can be pumped to the lungs, and to close during diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary artery carries deoxygenated blood from the right side of the heart to the lungs.

[0097] In addition to the pulmonary valve, the heart 1 also includes a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 typically has three cusps / leaflets and can typically close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 typically has two cusps / leaflets 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 normally, closes during systole to prevent blood from leaking 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 leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3.

[0098] A heart valve may typically have a relatively dense fibrous / collagen ring-like structure associated therewith (referred to herein as the valve annulus), and a plurality of leaflets or cusps attached to the annulus. Typically, the leaflets or cusps may be sized such that when the heart contracts, the resulting increased blood pressure generated within the corresponding heart chamber forces the leaflets to at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber drops, the pressure in the subsequent chamber or vessel may become dominant and press back on the leaflets. As a result, the leaflets / cusps become juxtaposed to one another, thereby closing the flow passage.

[0099] With respect to heart valves and associated interventions (e.g., annuloplasty procedures), particular reference is made herein to the mitral valve 6. However, it should be understood that any description herein of anatomy and / or devices or procedures associated with the mitral valve may be applied to other valves of the heart (e.g., tricuspid valve, aortic valve); in particular, reference is made to the mitral valve for convenience and / or due to its particular relevance.

[0100] Referring to the mitral valve 6, its annulus 10 attaches the mitral valve leaflets 13 and the left atrium 2 to the orifice and aortic root of the left ventricle 3. Under normal conditions, the mitral valve 6 undergoes significant dynamic changes in shape and size throughout the cardiac cycle. These changes are primarily due to the dynamic motion of the surrounding mitral valve annulus 10. Throughout the cardiac cycle, the annulus 10 typically undergoes sphincteric motion, narrowing the orifice area during systole to facilitate the coaptation of the leaflets 13, and widening during diastole to allow relatively easy diastolic filling of the left ventricle 3. This motion can be further enhanced by a pronounced three-dimensional configuration during systole, which can embody a unique saddle shape. The shape and form of the annulus 10 throughout the cardiac cycle can affect proper leaflet coaptation and / or tissue stress. Dysfunction of the heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) can lead to valve leakage and / or other health complications.

[0101] The atrioventricular (i.e., mitral and tricuspid) heart valves are typically connected to a collection of chordae tendineae 11 and papillary muscles 9 for securing the leaflets of the respective valves to promote and / or facilitate proper engagement of the valve leaflets and prevent their prolapse. For example, the papillary muscles may typically include finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles by the chordae tendineae 11. A muscular wall 17, called the septum, separates the left and right atria 2 and 5 and the left and right ventricles 3 and 4.

[0102] A variety of problems can disrupt blood flow through the heart's valves. For example, regurgitation (also known as valvular insufficiency or malfunction) occurs when a valve does not close properly and allows blood to flow backward instead of flowing in the correct one-way direction. The regurgitation can cause a decrease in the amount of blood that ultimately travels to the body's organs. To compensate for the regurgitation, the heart may work harder, which can ultimately cause heart enlargement / dilation and decreased cardiac output. In some cases, ischemic heart disease can cause valvular regurgitation. For example, mitral valve regurgitation can be caused by a combination of ischemic dysfunction of the papillary muscles and left ventricular dilation that may be present in ischemic heart disease, with subsequent displacement of the papillary muscles and dilation of the mitral valve annulus. Valvular problems may be present at birth or caused by infection, heart attack, heart disease, or injury.

[0103] Certain heart valve diseases / dysfunctions may be treated by performing certain annuloplasty treatments, which may help restore a deformed valve annulus to the physiological form and function of a normal, healthy valve (e.g., mitral valve) device. For example, annuloplasty treatment may include implanting a prosthetic annuloplasty device (e.g., a ring-shaped device, or "annuloplasty ring"). Annuloplasty treatment may be used to restore / reshape the annular dimensions of a heart valve annulus, which may promote proper leaflet coaptation and / or provide a wider coaptation surface. Annuloplasty procedures (including annuloplasty ring implantation) may effectively reshape the annulus to restore the size and physiological shape of the annulus (e.g., a D-shaped or kidney-shaped shape) and / or reduce the overall circumference of the annulus.

[0104] In some cases, the annuloplasty ring / device is constructed of a core material (such as silicone or metal) that provides the desired rigidity; annuloplasty rings can be designed to be relatively flexible, semi-rigid, or rigid. Some annuloplasty rings are wrapped in a cloth (e.g., Dacron or polyester) through which anchoring sutures can be placed. Annuloplasty rings can be formed in a variety of sizes, rigidities, and shapes, and can include partial bands or complete rings. 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, intercommissural distance, intertrigonal distance, etc.).

[0105] An annuloplasty ring implantation procedure may be performed by accessing the heart valve through the chest wall. For example, open heart surgical access may be utilized to access the heart and target valve. Alternatively, certain minimally invasive techniques may be performed in which one or more relatively small incisions are performed in the chest to access the valve. A transcatheter annuloplasty intervention may be used in which an implant device / assembly is advanced to the target valve annulus through the patient's vasculature, which may be accessed through the femoral vein or other access site / path. Transcatheter annuloplasty may be advantageous over surgical and minimally invasive procedures due to the reduced risk to the patient; transcatheter annuloplasty procedures according to aspects of the present disclosure may be particularly ideal for treating patients with mitral regurgitation who are considered inoperable or at high surgical risk.

[0106] Compared to traditional open heart surgery, the less invasive percutaneous implantation of annuloplasty devices according to embodiments of the present disclosure provides a relatively safer treatment. In addition, such procedures may allow for relatively early indication of treatment to increase the chance of prognostic benefit. Transcatheter annuloplasty devices according to embodiments of the present disclosure (including tissue anchors connected by tensioning tether / wire connectors) may produce results similar to surgical annuloplasty rings, such as in terms of reducing the lateral size of the septum and increasing the ability of the leaflets to coapt. An example system that may be used in conjunction with the tensioning solution presented herein is the Cardioband Mitral Reconstruction System by Edwards Lifesciences, a percutaneous direct annuloplasty device implantable in a beating heart. Such devices may be implanted on the posterior annulus under the guidance of fluoroscopy and transesophageal echocardiography (TEE). After implanting the tissue anchor associated with the implant device in or near the native valve annulus, the device may be contracted using wire / thread tensioning to reshape the annulus and improve mitral regurgitation.

[0107] Further references Figure 1 , illustrates at least a portion of an annuloplasty implant system that may be at least partially adjustable after implantation of one or more tissue anchors 102 . Figure 2 1 shows a top view of an annuloplasty implant system 200 implanted in a native heart valve annulus 10 according to one or more embodiments. Figure 2 In the image of FIG. 1 , tension wire 210 is used to interconnect multiple tissue anchors 202 and / or can be tensioned and / or locked. A retractable delivery system (including, for example, outer catheter 101, inner catheter 103, channel 107 and / or delivery shaft 105, such as Figure 1 shown).

[0108] The anchor 102 can be fixed to the native annulus 10 and / or other anatomical structures around the valve orifice / leaflet. In some embodiments, the implant system can include a sleeve (e.g., polyester) surrounding at least a portion of the wire 210 and / or the anchor 102 / 202. Tensioning of the wire 210 can effectively shorten the implant system, thereby adjusting the size of the implant system according to the patient's needs. The tensioning can be performed under imaging (e.g., echo) guidance as a means of producing and confirming the desired regurgitation reduction.

[0109] The tissue anchor 102 / 202 can be delivered to the target anatomical structure using a delivery system that can include, for example, one or more delivery and / or guide catheters and / or access sheaths, including an outer catheter 101, an inner catheter 103, a channel 107, and / or a delivery shaft 105 and / or a sheath, any of which can be steerable. For mitral valve repair, at least a portion of the delivery system can be advanced through the atrial septum. Catheters 101, 103 can include a steerable guide catheter, and a flexible tube configured to be advanced through the guide catheter to facilitate delivery and implantation of the tissue anchor 102 therein. 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 annulus 10 of the target valve (e.g., the mitral valve 6).

[0110] The implant system may include a plurality of implantable tissue anchors 102 / 202 which may include metal or other biocompatible materials. In some embodiments, the anchor 1020 / 202 is a helical tissue anchor having a proximal drive head which may be engaged by a drive shaft 105 to embed 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 embodiments, the tissue anchor 102 / 202 comprises a stainless steel anchor having a length between 5-10 mm (e.g., approximately 6 mm). The anchor 102 / 202 may be used to secure the connecting wire / filament 210 to the target tissue (e.g., the annulus 10). Although Figure 2 Eighteen anchors 202 are shown in FIG. 1 , but it should be understood that any number of tissue anchors may be implemented, such as any number between twelve and twenty. Prior to full deployment of the implant device, the anchors 102 / 202 may be repositionable and / or retrievable, such as Figure 2 shown.

[0111] Certain procedures / operations may be implemented to deliver and anchor the implant device. For example, the delivery system may be advanced toward the annulus 10. In some embodiments, the outer catheter / sheath 101 may be advanced through the patient's vasculature into the right atrium 5 and through the atrial septum until its distal end is positioned in the left atrium 2. The steerable distal end portion of the outer catheter / sheath may then be steered so that it is positioned in a desired spatial orientation within the left atrium 2. The steering procedure may be performed with the assistance of imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0112] Any suitable or desired access route can be used to enter the right atrium 5, such as through the femoral vein and / or through the artery. It should be understood that any suitable starting point is possible. For example, access can be achieved by introducing into the femoral vein of the patient, passing through the inferior vena cava 19, entering the right atrium 5, and entering the left atrium 2 through the septum (e.g., through the fossa ovalis). In some embodiments, access can be achieved by entering the right atrium 5 through the basilic vein, the subclavian vein, the superior vena cava 16. In some embodiments, access can be achieved by entering the right atrium 5 and / or the left atrium 2 via the jugular vein, the subclavian vein, the superior vena cava 16.

[0113] Such access can be used to advance a guidewire to a target location within the left atrium 2. For the purpose of traversing the atrial septum, a relatively rigid guidewire can be used. The delivery system can be advanced into the left atrium 2 over the guidewire. The inner catheter 103 can be placed above the anterior commissure to provide a suitable operating position for deploying the first anchor 202a. Imaging can be used to obtain verification of the first anchor position. In some embodiments, the first anchor 202a is placed near the leaflet hinge, as anteriorly as possible in the annulus, and close to the anterior commissure.

[0114] The first anchor 202a can be delivered and implanted using an anchor delivery drive shaft 105, which can be set in the catheter 101, 103. After checking the correct anchoring with a push-pull test under imaging guidance (e.g., echocardiography, fluoroscopy), the anchor 102 / 202 can be released. After correctly anchoring one anchor, the catheter 101, 103 can be navigated (e.g., using the steering knob of the proximal handle / system, etc.) to the next anchor point along the annulus. Such actions can be repeated until the end of the implant catheter reaches the final anchoring position, in which the final anchor 202b is deployed. The implant device can then be disconnected from the delivery catheter 101, 103, and the tension wire 210 passes from the tissue anchor 102 / 202 through the sheath 101, 103 and the patient's anatomical structure to a position outside the body, where an adjustment tool can be advanced through the tension wire 210 to allow the tension of the wire / line 210 to be adjusted.

[0115] The tension adjustment tool / device can be actuated / controlled to cause the tensioning wire / thread 210 to contract. 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 / thread 210. After and / or during tensioning, imaging (e.g., echo) can be used under beating heart conditions to assess sufficient reduction of heart valve regurgitation or other defects. When tensioning has caused the appropriate implant size / diameter to be achieved, the tensioning device / tool ​​can be used to cut and / or lock the tension in the wire / thread 210, after which the non-implant device can be withdrawn from the patient's body, so that the implant has the desired degree of contraction.

[0116] The anchor 202 may be sequentially anchored around all or part of the annulus 10 (eg, 40-90%, 50-70%, etc.), and then the wire / thread 210 may be tensioned to shrink the annulus 10, such as Figure 2 In some embodiments, the tensioning wire 210 will be sufficient to substantially reduce or eliminate regurgitation through the native valve, in which case the method / procedure may be terminated. In some embodiments, if substantial regurgitation still exists at the native valve (e.g., shortly after the initial procedural step / tensioning, or after more time has passed, such as months or years), a replacement prosthetic valve may be deployed in the native valve annulus.

[0117] Implantation of the device may advantageously increase leaflet coaptation and / or provide support to the posterior annulus to prevent dilatation. Compared to some surgical annuloplasty ring devices, Figure 2 The illustrated annuloplasty implant, including a plurality of tissue anchors 202 coupled to a common tensioning wire / thread 210, may advantageously provide improved flexibility to maintain the three-dimensional contours of the native annulus and some of its natural dynamics.

[0118] Can use locking clamp / mechanism 282 to lock the tension in silk / line 210, locking clamp / mechanism can be connected to silk / line 210 at the near side of last anchor 202b.The redundant part of silk 210 can be cut and removed.In addition, pin 214 and / or similar mechanism can be configured to anchor silk / line 210 at the starting point of silk / line 210.

[0119] Figure 3 An example implant system 300 is illustrated in which one or more tissue anchors 302 anchor annuloplasty tube 330 to annuloplasty tissue 10 of mitral valve 3, in accordance with one or more embodiments. Annuloplasty tube 330 may be additionally anchored using one or more pins, including a first pin 344 at or near a first tissue anchor 302a and / or a second pin 342 at or near a last tissue anchor 302b.

[0120] Figure 4An example tissue anchor 402 is illustrated in accordance with one or more embodiments. The tissue anchor 402 can be a component of a tissue modulation system and can be used to adjust the size of a tissue structure. For example, the tissue modulation system can be an annuloplasty system and / or the tissue anchor 402 can be used to anchor an annuloplasty structure (e.g., an annuloplasty ring, annuloplasty implant, etc.).

[0121] Anchor 402 may include tissue engagement element 430 and / or head 480 portion. Tissue engagement element 430 can be constructed in a variety of ways. In some embodiments, tissue engagement element 430 may have a proximal end 432 and / or a distal end 434 and / or may define the central longitudinal axis A of anchor 402. At distal end 434, tissue engagement element 430 may have a sharp distal tip 438 and / or tissue engagement element 430 may be configured to be driven (e.g., twisted, pushed, etc.) into the tissue of the subject. In some embodiments, as shown in the figure, tissue engagement element 430 may be spiral and / or may define central lumen 436 along axis A. Optionally, tissue engagement element 430 may be another type of tissue engagement element 430, such as a dart-shaped nail or nail. In some embodiments, tissue engagement element 430 may be hook-shaped, straight, angled and / or another configuration. In some embodiments, tissue engagement element 430 may include a barb or a barb portion to keep the tissue engagement element in the tissue.

[0122] The tissue engaging element 430 may have any suitable lateral width. For embodiments where the tissue engaging element 430 is a spiral (e.g., Figure 4 The head 480 of the anchor 402 may be coupled to the proximal end 432 of the tissue engaging element 430 and / or may include a driver interface 482 and / or an eyelet 440 that may define an orifice 446 therethrough. The driver interface 482 may be configured to be reversibly engaged by an anchor driver (e.g., see Figure 5 ). In some embodiments, the anchor driver can include an elongated and / or flexible shaft and / or a driver head coupled to the distal end of the shaft. The driver head can be a component of the anchor driver that reversibly engages the driver interface 482. The driver interface 482 can be rigidly coupled to the tissue engaging element 430.

[0123] In some embodiments, as shown, the driver interface 482 can be disposed on a central longitudinal axis A, and the eyelet 440 can be disposed laterally from the axis A.

[0124] In some embodiments, the anchor 402 (e.g., its connector or eyelet 440) can be configured to facilitate the sliding of the anchor 402 along the wire (or the sliding of the wire through the anchor 402) when the anchor 402 is aligned with the wire (e.g., when the axis A is parallel to the wire). The anchor 402 (e.g., its connector or eyelet 440) is configured to facilitate the sliding of the anchor 402 along the wire (or the sliding of the wire through the anchor 402) when the anchor 402 is oriented orthogonal to the wire (i.e., when the axis A is orthogonal to the wire). This can be achieved at least in part due to the shape and size of the connector or eyelet 440.

[0125] The eyelet 440 may define an aperture 446 in an aperture plane and / or may be mounted such that the aperture plane is inclined at a fixed angle (eg, approximately 30-60 degrees, such as 45 degrees, to the axis A).

[0126] In some embodiments, the eyelet 440 is shaped to define (i) a first unobstructed linear path through the orifice 446 along a first line parallel to the axis A, and (ii) a second unobstructed linear path through the orifice 446 along a second line orthogonal to the first line. This shape can advantageously allow the eyelet 440 to slide along the wire in any of these mutually orthogonal orientations. The shape of the eyelet 440 can similarly facilitate its sliding along the wire when it is midway between these mutually orthogonal orientations.

[0127] Regardless of the actual shape of the orifice 446 described above, the shape and size of the eyelet 440 can be set so that the orifice 446 appears to be circular when (i) viewed along a first line parallel to the axis A (i.e., a first line of sight) and (ii) viewed along a second line orthogonal to the first line of sight (i.e., a second line of sight). Such a shape can advantageously allow the eyelet 440 to slide smoothly along the wire in any of these orientations (and typically also in continuous orientations between them). Thus, these lines of sight can be considered to be the first and second sliding axes of the anchor 402 (e.g., the eyelet 440 thereof). Such a shape can advantageously allow such sliding even when the wire is greater than 50% (e.g., greater than 70%, such as greater than 90%) of the diameter of the apparent circular shape of the orifice 446.

[0128] To further facilitate smooth sliding of the wire through the orifice 446, the eyelet 440 defines an inclined edge around the orifice. In some embodiments, as shown, the bevel on the major axis is larger than the bevel on the minor axis (i.e., at the sides of the orifice 446). In some embodiments, on each face of the eyelet 440 (i.e., on each side of the orifice 446), the eyelet 440 defines a bathtub-shaped cavity, the bottom of the bathtub meeting to form the orifice 446.

[0129] In some embodiments, as shown in the figure, the eyelet 440 is installed to be rotatable or rotatable around the axis A, while the orifice plane remains tilted at a fixed angle relative to the central longitudinal axis. Optionally, the eyelet 440 can be rotatable and / or rotatable around another axis. For example, the head 480 may include a ring 484 on which the eyelet 440 is installed. The ring 484 can surround the axis A and / or can be rotatable around the axis A (for example, by being rotatably coupled to the tissue engagement element 430, such as by being rotatably coupled to another component of the head 480, such as a driver interface 482 fixedly coupled to the tissue engagement element).

[0130] In some embodiments where tissue engaging element 430 is a helix, the helix of tissue engaging element 430 is inclined in the same direction as the orifice plane relative to axis A on the side of anchor 402 where eyelet 440 is located. However, the lead angle of the helix of tissue engaging element 430 may be different than the angle of the orifice plane.

[0131] As described above, the anchor 402 (e.g., its eyelet 440) can be configured to facilitate the sliding of the anchor 402 along the wire (or the sliding of the wire through the anchor 402) when the anchor 402 is aligned with the wire (e.g., when the axis A is parallel to the wire). This can facilitate the transcatheter advancement of the anchor 402 along the wire. As also described above, the anchor 402 (e.g., its eyelet 440) is configured to facilitate the sliding of the anchor 402 along the wire (or the sliding of the wire through the anchor) when the anchor 402 is oriented orthogonal to the wire (i.e., when the axis A is orthogonal to the wire). This is useful for embodiments where the wire is tensioned after implantation to adjust for anatomical dimensions, such as annuloplasty.

[0132] Figure 5 An example 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 embodiments is illustrated. The delivery system may include an elongated shaft 505, which may include one or more flexures 507, which include any of the various features described herein with respect to the flexures. The elongated shaft 505 may extend between a drive handle 518 at the proximal side and / or end of the shaft 505 and / or a driver 520 at the distal side and / or end of the shaft 505. The driver 520 may be configured to be connected to a head 580 portion and / or a drive interface of the tissue anchor 502. For example, the driver 520 may include a generally rectangular protrusion configured to cooperate with a similar rectangular interface of the tissue anchor 502.

[0133] The drive handle 518 can be coupled to a torque limiter 516 that is configured to prevent and / or inhibit excessive twisting of the elongated shaft 505. For example, the torque limiter 516 and / or the drive handle 518 can be configured to twist to induce twisting and / or torsional forces in the elongated shaft 505 and / or the tissue anchor 502. The torque limiter 516 can be configured to prevent and / or inhibit twisting of the shaft at or above a threshold torque amount.

[0134] In some embodiments, the torque limiter 516 may include various components, which may include a dimple, a ball bearing, and / or a washer pressed against the ball bearing. The torque limiter 516 may be calibrated with a screw and / or similar mechanism. When the torque limiter is rotated, the ball bearing may be configured to shift when the torque exceeds a predetermined amount and / or may rotate freely to not engage the anchor driver.

[0135] The elongated shaft 505 can be an inner shaft of a delivery system and / or can be configured to be delivered at least partially through an outer shaft. For example, at least a portion of the elongated shaft 505 can be configured to extend through a catheter and / or other outer shaft during delivery into a patient. The outer shaft can be configured to at least partially surround the elongated shaft 505.

[0136] like Figure 5 As shown, the flexure 507 can be disposed at or near the distal end of the elongated shaft 505. For example, the flexure 507 can be closer to the driver 520 than the handle 518. However, the flexure 507 can be disposed anywhere along the elongated shaft 505.

[0137] In some embodiments, the flexure 507 can be an extension of the elongated shaft 505. For example, the flexure 507 can represent a portion of the elongated shaft 505 that includes one or more features configured to facilitate a change of state of the elongated shaft 505 and / or the flexure 507. In some embodiments, the flexure 507 can include a cutout 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 separated and / or disconnected portions of the elongated shaft 505. The flexure 507 can include one or more features configured to cause a change of state of the elongated shaft 505 in response to the tissue anchor 502 being fully embedded in the tissue and / or in response to twisting and / or torsion of the elongated shaft 505 meeting and / or exceeding a threshold amount of force. In some embodiments, the flexure 507 can be configured to have a first state during delivery and / or to assume a second state during the actuation and / or delivery process of the tissue anchor 502 (e.g., once the tissue anchor 502 has been fully driven into the tissue and additional torsional forces are applied). For example, once the tissue anchor 502 is fully embedded in the tissue when the driver 520 is engaged with the head 580, additional torsional forces at the elongated shaft 505 and / or the handle 518 can cause the flexure 507 and / or the elongated shaft 505 to move from the first state (e.g., a substantially linear state) to the second state (e.g., a bent state).

[0138] The flexure 507 may include one or more features configured to facilitate delivery and / or actuation of the elongated shaft 505 and / or tissue anchor 502. For example, the flexure 507 may be configured to have a generally flexible state during delivery and / or to assume a generally rigid state prior to actuating the tissue anchor 502 to a target tissue site. In some embodiments, one or more pull wires may extend at least partially through the elongated shaft 505 and / or the flexure 507 (e.g., through an aperture in a wall of the elongated shaft 505 and / or the flexure 507) to facilitate movement of the flexure 507 and / or the elongated shaft from a first state to a second state and / or vice versa.

[0139] Although the flexure 507 is Figure 5 507 is shown as a portion of an elongated shaft 505 configured to drive one or more tissue anchors 502, but the flexure 507 can be a component of other shafts. For example, an outer shaft configured to receive and / or facilitate delivery of the elongated shaft 505 can include one or more flexures 507 at various locations.

[0140] Figure 6A system 600 (e.g., an anchor delivery system, an implant delivery system, etc.) for delivering one or more tissue anchors 602 into a tissue 10 is illustrated according to one or more embodiments. The system 600 may include a catheter 601 (e.g., an elongated shaft and / or an outer shaft) and / or a shaft 605 (e.g., an elongated 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 to deliver one or more tissue anchors 602 and / or a tether 610 (e.g., a wire and / or a rope) on which the tissue anchor 602 is threaded (e.g., through one or more eyelets 640 of the tissue anchor 602). As described in more detail below, during implantation, only the distal portion of the tether 610 may remain implanted in the subject, while the proximal portion of the tether remains attached to the delivery system 600.

[0141] The tissue anchors 602 may be distributed continuously along the tether 610, and the delivery system 600 may be used to implant one or more tissue anchors 602 by using an anchor driver 612, successively for each of the anchors 602, to advance the anchors 602 distally into the subject and anchor the anchors 602 to the subject's internal tissue. For example, as shown, one or more tissue anchors 602 and / or the tether 610 may include an annuloplasty implant that is implanted by distributing the anchors 602 around at least a portion of the annulus of a subject's native heart valve, such as the mitral valve or the tricuspid valve. In addition, in some embodiments, the distal end of the tether 610 may be advanced distally into the subject along with the first anchor, and subsequent anchors 602 may be advanced by sliding them distally along the tether 610. In some embodiments, system 600 and / or the described techniques used therewith are used in combination with one or more of the systems and / or techniques described in U.S. Provisional Patent Application 62 / 949,392, entitled “ANNULOPLASTY AND TISSUE ANCHOR TECHNOLOGIES,” filed by Kasher et al. on December 17, 2019, which is incorporated herein by reference.

[0142] Catheter 601 can be configured to be advanced into a subject. In some embodiments where the implant is an annuloplasty implant, catheter 601 can be a transluminal (e.g., transfemoral) advanceable catheter as shown. Catheter 601 can extend from an extracorporeal unit (e.g., an extracorporeal unit) that is configured to remain outside the subject's body. In some embodiments, the extracorporeal unit defines or is coupled to a handle of the device. Tissue anchor 602 can include various features (e.g., a head 680 portion) to allow tissue anchor 602 to be connected to and / or attached to a driver 612 of shaft 605.

[0143] The extracorporeal unit may include a tensioner including a capstan that facilitates reducing slack on the tether 610 during distal sliding of the anchor 602 along the tether 610. Reducing slack may advantageously reduce the likelihood that the tether 610 will become twisted or tangled, or that the tether 610 will accidentally engage with the delivered anchor 602. Using a capstan to reduce slack rather than manually pulling the proximal end of the tether 610 by a human operator may further advantageously provide greater control over the amount and consistency of tension applied to the tether 610, and may further advantageously reduce the number of human operators required.

[0144] Figure 7 Anchoring one or more tissue anchors to tissue 10 is illustrated in accordance with one or more embodiments. Figure 7 In the figure, at least the rightmost anchor has been successfully anchored, and the leftmost anchor has not been successfully anchored. Therefore, by comparing the left anchor with the other anchors, the behavior of the anchors (including the movement of the protrusion relative to the head 780) can be understood from these figures.

[0145] In some embodiments, the catheter 701 and / or similar devices can be configured to deliver the shaft 705 and / or one or more anchors 702 via the lumen of the catheter 701. The tether 710 can be configured to interconnect the various tissue anchors 702 and / or can be passed through one or more eyelets, which can extend from the head 780 portion of the tissue anchor 702. The driver 712 of the shaft 705 can be configured to engage the head 780 portion to carry and / or drive the tissue anchor 702. The shaft 705 can be configured to drive the tissue engaging element 730 of the anchor 702 into the tissue until the proximal end 734 of the tissue engaging element 730 and / or the washer 732 or similar mechanism of the anchor 702 between the tissue engaging element 730 and the head 780 reaches the tissue 10. The catheter 701 and / or the shaft 705 can be part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0146] Figure 8The delivery of one or more tissue anchors 802 into tissue 10 is illustrated in accordance with one or more embodiments. A delivery system (e.g., an anchor delivery system, etc.) may include an outer catheter 801, an inner catheter 803, and / or a channel 807 through which a drive shaft 805 may pass, etc. In some embodiments, one or more tissue anchors 802 may be configured to be anchored at least partially through an elongated cannula 826. A portion of a lateral wall of the cannula 826 is aligned against the tissue 10 in a manner such that a surface of the portion of the lateral wall is disposed parallel to a flat surface of the tissue 10. Additionally, a distal end of the channel 807 extending about the shaft 805 may be configured to flatten a portion of the side wall against the annular tissue 10 such that the channel 807 sandwiches a portion of the side wall between a distal end of the implant separation channel and a portion of the annular tissue 10 at the flat surface in which the tissue anchor 802 is implanted. In this manner, the anchored portion of the sidewall lies flat against the annulus tissue 10 (parallel to its flat surface), while the remainder of the tubular sidewall is disposed substantially perpendicularly relative to the tissue portion in which the tissue anchor 802 is implanted.

[0147] In some embodiments, different tissue anchors 802 can be deployed through different portions and / or sides of the cannula 826. For example, a first tissue anchor 802 can be deployed through an end wall of the cannula 826 and / or a second tissue anchor can be deployed through a side wall of the cannula 826. However, the plurality of tissue anchors 802 can extend in substantially the same direction and / or into a common substantially flat surface of the valve annulus. In some embodiments, the tissue anchors 802 can be disposed at an angle of between 0 and 45 degrees (e.g., between 0 and 30 degrees, such as between 0 and 20 degrees) relative to each other.

[0148] In some embodiments, the maximum distance between the anchor points of the first and second tissue anchors 802 can be provided by the length of the cannula 826 that has been separated from a portion of the channel 807 (e.g., provided by the distance that the channel 807 has been retracted from the cannula 826, e.g., between 3 and 15 mm, e.g., 8 mm). That is, in some embodiments, the second tissue anchor 802 can be placed anywhere within a circle having a radius equal to the distance between the first and second anchors 802, centered on the first tissue anchor 802. In some embodiments, the cannula 826 can be used as a restraining member (e.g., a tether) that can be used to facilitate the positioning of the second tissue anchor 802. The distance between the tissue anchors 802 can be set by the operating physician retracting the channel 807 from the cannula 826 a specific distance.

[0149] Fig. 9The delivery shaft 905 is illustrated as being delivered to a chamber of the heart (e.g., the right atrium 5) according to one or more embodiments. For example, the delivery shaft 905 may be delivered upwardly via the inferior vena cava 29 into the right atrium 5. In some embodiments, one or more delivery shafts 905 may be configured for delivery via other pathways, including delivery via the superior vena cava into the right atrium 5. For illustrative purposes, delivery via the inferior vena cava 29 is shown, and the devices and / or methods described herein may be applicable to other delivery procedures and / or other anatomical structures. The delivery shaft 905 may be part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0150] The location of the tricuspid valve 6 relative to the inferior vena cava 29 and / or the superior vena cava may require a curvature of the delivery shaft 905 delivered via the inferior vena cava 29 and / or the superior vena cava. For example, the opening of the inferior vena cava 29 into the right atrium 5 may be adjacent to the tricuspid valve 6 at a relatively common plane and / or along a lower portion of the right atrium 5. When the delivery shaft 905 exits the inferior vena cava 29 and enters the right atrium 5, the delivery shaft 905 may be directed toward an upper region of the right atrium 5. In order to reach the tricuspid valve 6, the delivery shaft 905 may need to be bent into a generally U-shape to redirect the distal end of the delivery shaft 905 toward the tricuspid valve 6, such as Fig. 9 Target orientation 914 is shown in FIG. In the case where the delivery shaft 905 is delivered via the superior vena cava, the delivery shaft 905 may similarly need to bend to reach the tricuspid valve 6. Therefore, it may be advantageous for the delivery shaft 905 to be at least partially flexible to enable access to the tricuspid valve 6 via the inferior vena cava 29 and / or the superior vena cava and / or to enable access to other anatomical structures via other pathways.

[0151] The delivery shaft 905 can be configured to deliver one or more anchors 902, which can be configured to extend through the lumen of the delivery shaft 905 and / or extend from the distal end of the delivery shaft 905. The delivery shaft 905 can be configured to bend so that the one or more anchors 902 at the distal end of the delivery shaft 905 are positioned at or around the tricuspid valve 6 and / or another valve.

[0152] Fig.10 An example flexible delivery shaft 1005 is illustrated that is configured to deliver one or more anchors 1002 at different portions of the anatomy, which may include at or around the tricuspid valve 6, the mitral valve, and / or another valve. Fig.10One embodiment of a delivery shaft 1005 is illustrated that includes a flexure (including tabs 1017 that interconnect segments 1018 and / or flexures of the delivery shaft 1005 for illustrative purposes), but other embodiments described herein may be used to allow for improved flexibility when delivering one or more anchors 1002 to a target anatomical structure. The delivery shaft 1005 may be part of / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0153] In some embodiments, the delivery shaft 1005 may include multiple portions and / or segments 1018, which may include one or more flexures and / or one or more non-flexures. The flexures 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, the flexure may include a portion of the delivery shaft including one or more tabs 1017 and / or segments 1018, such as Fig.10 In some embodiments, the delivery shaft 1005 can include at least one flexure at or near the distal end and / or distal portion of the delivery shaft 1005. For example, the flexure can be configured to enable the distal portion of the delivery shaft 1005 to bend to allow one or more anchors 1002 to be deployed at a target location from the distal portion.

[0154] The flexures may be configured to selectively provide improved flexibility and / or rigidity. In some embodiments, the flexures may be transformed, converted, and / or modified from a first state providing improved flexibility to a second state providing improved rigidity, and / or from a second state providing improved rigidity to a first state providing improved flexibility. For example, the flexures may be configured to provide improved flexibility during delivery to a target location and / or may be modified 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). In addition, the flexures may be configured to be transformed / modified to provide improved flexibility to facilitate removal of the delivery shaft from the body.

[0155] In some embodiments, one or more flexures may be modified by the surgeon during the procedure and / or in other ways. For example, the surgeon may use one or more pull wires and / or similar devices (e.g., actuating knobs, buttons, or other control devices to tighten the pull wires, etc.) to cause the flexures to transform 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 flexures may be configured to bend into Fig.10 The "U" shape shown.

[0156] Fig.11 An example assembly 1100 for driving one or more anchors into target tissue according to one or more embodiments is illustrated. The assembly 1100 may include a catheter and / or an outer shaft (see Fig.12 and Fig.13 ) and / or can be configured to be used alone or in combination with other components. Assembly 1100 can be configured as an anchor delivery system, or can be a part of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0157] In some embodiments, the assembly 1100 may include a plurality of different and / or interconnected segments. At the distal end of the assembly 1100, the assembly 1100 may include a clamp 1112 that is configured to clamp to and / or otherwise engage one or more tissue anchors. For example, the clamp 1112 may be configured to fit into a notch and / or orifice in the head of the tissue anchor and / or may be configured to fit at least partially around the tissue anchor. In some embodiments, the assembly 1100 may include a groove cut around the clamp 1112 and / or be configured to cooperate with a protrusion of another catheter and / or assembly.

[0158] The assembly 1100 can be at least partially flexible to facilitate delivery of the assembly 1100 through the body and / or to a target tissue site via one or more pathways. In some embodiments, the assembly 1100 can have varying flexibility along the length of the assembly 1100. For example, the assembly 1100 can include a substantially flexible section 1101 at or near a distal end of the assembly 1100, a substantially rigid section 1103 at or near a proximal end of the assembly 1100, and / or a semi-flexible section 1102 between the substantially flexible section 1101 and the substantially rigid section 1103. In some embodiments, the substantially flexible section 1101, the semi-flexible section 1102, and / or the substantially rigid section 1103 can be longitudinally aligned and / or can form an axis extending between a handle 1118 and a clamp 1112 of the device. The flexible section 1101 can have a smaller width and / or diameter than the semi-flexible section 1102 and / or the substantially rigid section 1103, such as Fig.11 1103. However, the flexible segment 1101 may optionally have a width and / or diameter that is approximately equal to the semi-flexible segment 1102 and / or the substantially rigid segment 1103. The flexible segment 1101 may be at least slightly more flexible than the semi-flexible segment 1102 and / or the substantially rigid segment. In some embodiments, the increased flexibility of the flexible segment 1101 and / or the semi-flexible segment 1102 relative to the substantially rigid segment 1103 may be at least partially attributed to being at least partially constructed of a different material and / or having a smaller width, diameter, and / or wall thickness.

[0159] In some embodiments, assembly 1100 may further include a threaded section 1104 disposed at least partially between substantially rigid section 1103 and handle 1118. Flexible section 1101, semi-flexible section 1102, rigid section 1103, and / or threaded section 1104 may be configured to at least partially fit over an outer catheter (e.g., Fig.12 Thus, the various sections of assembly 1100 may be generally thin to allow the sections to fit within the outer catheter.

[0160] In some embodiments, assembly 1100 and / or the shaft of assembly 1100 may be generally incompressible. However, assembly 1100 may have some flexibility. For example, flexible segment 1101 may have a bending radius of approximately 10 mm, semi-flexible segment 1102 may have a bending radius of approximately 25 mm, and / or rigid segment 1103 may have a relatively higher bending radius. Flexible segment 1101 may have a length of approximately 120 mm, semi-flexible segment 1102 may have a length of approximately 988 mm, and / or rigid segment 1103 may have a length of approximately 620 mm.

[0161] The shaft of assembly 1100 may have an inner diameter of about 0.5 mm or greater. The outer diameter may be small enough to fit within an outer assembly (e.g., Fig.12 The shaft may have a default straight and / or linear form.

[0162] In some embodiments, the assembly 1100 may include one or more flexures. For example, the flexible segment 1101 may include cuts that separate the flexible segment 1101 into disconnected portions, and / or may include one or more coils and / or wires configured to interconnect the disconnected portions. The flexures may be configured to bend, and / or the disconnected portions of the flexures may be configured to deflect in response to twisting of the handle 1118 and / or the various axes of the assembly 1100.

[0163] Fig.12 At least a portion of an assembly 1200 for delivering and / or driving one or more tissue anchors to a target tissue location is illustrated in accordance with one or more embodiments. In some embodiments, assembly 1200 can be configured for use with one or more other devices. For example, assembly 1200 can be configured for use as an outer catheter / sheath, and / or can be configured to receive an inner catheter / shaft and / or assembly (e.g., Fig.11 1100). The assembly 1200 can be configured as an anchor delivery system, or can be a part of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0164] In some embodiments, the assembly 1200 can include a plurality of distinct and / or interconnected segments and / or portions, which can include a flexure 1210, a substantially flexible segment 1211, a semi-flexible segment 1212, and / or a substantially rigid segment 1213. The flexure 1210 can be at least partially compressible from an expanded form (e.g., during delivery) to a compressed form (e.g., after delivery and / or when driving one or more tissue anchors into tissue).

[0165] Component 1200 may include one or more control devices or control features, which may include knobs 1215, buttons, switches, sliders and / or similar mechanisms. For example, knob 1215 may be placed at the proximal end of component 1200. In some embodiments, knob 1215 may be configured to control the compression, expansion and / or other transformations of flexure 1210. For example, when knob 1215 is rotated in a first direction (e.g., counterclockwise), flexure 1210 may be compressed to become more rigid. Similarly, when knob 1215 is rotated in a second direction (e.g., clockwise), flexure 1210 may be decompressed and / or may become more flexible. By compression, flexure 1210 may be configured to resist the compressive load applied when the wire passing through component 1200 is under tension.

[0166] In some embodiments, assembly 1200 can be configured to cooperate with various features and / or devices. For example, assembly 1200 can include one or more protrusions (e.g., at the distal end of assembly 1200) that are configured to cooperate with Fig.11 The corresponding groove of the component 1100 of the embodiment can be matched. In this way, the component 1200 and / or other components and / or conduits can be held together to prevent and / or inhibit displacement relative to each other.

[0167] The various segments of assembly 1200 can form a tubular shaft that is configured to receive and / or deliver one or more wires and / or tissue anchors. In some embodiments, the various segments can have varying flexibility to facilitate delivery of assembly 1200 through various anatomical pathways. The various segments of assembly 1200 can be at least partially constructed of different materials and / or can include at least partially different wall thicknesses and / or lumen widths and / or diameters relative to each other.

[0168] The flexure 1210 may be at least partially compressible and / or other portions of the shaft of the assembly 1200 may be substantially incompressible. In some embodiments, the flexure 1210 may have a length of approximately 30 mm and / or the substantially flexible section 1211 may have a length of approximately 90 mm. The semi-flexible section 1212 may have a length of approximately 988 mm and / or the rigid section 1213 may have a length of approximately 620 mm. In some embodiments, the flexure 1210 and / or the substantially flexible section 1211 may be configured to fit within a Fig.11 The semi-flexible section 1212 may be configured to fit at least partially within the substantially flexible section 1101 of the assembly 1100. Fig.11 The rigid section 1213 may be configured to fit at least partially within the semi-flexible section 1102 of the assembly 1100. Fig.11 within the rigid section 1103 and / or the braided section 1104 of the component 1100 .

[0169] In some embodiments, the shaft of assembly 1200 may have an inner diameter large enough to accommodate Fig.11 The outer diameter of the shaft of assembly 1100 fits into the lumen of assembly 1200. The shaft of assembly 1200 may have an outer diameter of about 2.41 mm or less.

[0170] Fig.13 An example assembly 1300 is shown that is configured to deliver and / or drive various tissue anchors to a target tissue location in accordance with one or more embodiments. In some embodiments, the assembly 1300 may include an inner catheter and / or an assembly (e.g., Fig.11 1100) and / or an outer catheter and / or component (e.g., Fig.12 1200 of the assembly). The outer assembly may include an axis 1317 configured to receive a corresponding axis of the inner assembly and / or extend at least partially above the corresponding axis of the inner assembly. Assembly 1300 may include a flexure 1310 configured to facilitate state changes of the outer assembly and / or the inner assembly. For example, the flexure 1310 may be disposed at a distal portion of the axis 1317 and / or may be configured to transition or modify from a flexible state to a rigid state. In some embodiments, assembly 1300 may include a knob 1315 and / or a similar mechanism configured to selectively control the transition of the flexure 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 part of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0171] Assembly 1300 may include a handle 1318 and / or the like configured to be manipulated by a surgeon for controlled delivery of shaft 1317 and / or other portions of assembly 1300 into and / or through the body. In some embodiments, knob 1315 and / or other control mechanisms may be disposed at or near handle 1318.

[0172] The flexure 1310 may include any suitable state change feature as described herein. For example, the assembly 1300 may include one or more pull wires extending at least partially through the flexure 1310 to control and / or facilitate the state change of the flexure 1310. The one or more pull wires may be controlled at least in part using a handle 1318 and / or a knob 1315. Although the flexure 1310 is illustrated as including a series of interlocking plates 1328 and / or teeth, the flexure 1310 may include alternative and / or additional features. For example, the flexure 1310 may include one or more springs and / or a wire network.

[0173] FIG. 14A to FIG. 14C An example flexure 1400 of one or more shafts of a tissue anchor delivery assembly according to one or more embodiments described herein is illustrated. In some embodiments, the delivery assembly may include 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, delivery systems, and / or medical implants (e.g., tissue anchors). The flexure 1400 may similarly have a generally tubular form and / or may include an inner lumen. The flexure 1400 may be a portion / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0174] The flexure 1400 may include a network of one or more loops 1418 interconnected by one or more tabs 1417. One or more tabs 1417 may be configured to extend between multiple loops 1418 of the flexure 1400. In some embodiments, the loops 1418 may have a circular and / or cylindrical form. One or more tabs 1417 may have any suitable form, including a rectangular shape. The flexure 1400 may include any number of tabs 1417 and / or any number of tabs 1417 may be used to bridge two loops 1418 of the flexure 1400. For example, the flexure 1400 may include two tabs 1417 or four tabs 1417 between each pair of loops 1418.

[0175] In some embodiments, the flexure 1400 may include a pair of tabs 1417 that are disposed generally opposite each other across the lumen of the flexure 1400. For example, Fig.14AAs shown, a set of tabs 1417 is shown, wherein a first tab 1417a may be disposed generally opposite a second tab 1417b. The flexure 1400 may include multiple pairs of tabs 1417 bridging two loops 1418. For example, Fig. 14B As shown, a set of tabs 1417 is shown, wherein the flexure may include a first tab 1417a generally opposite a second tab 1417b and / or may include a third tab 1417c generally opposite a fourth tab 1417d.

[0176] The flexure 1400 can have any suitable length l. In some embodiments, the flexure 1400 can include any number of loops 1418 and / or tabs 1417 extending along the length of the flexure 1400. Although the flexure 1400 is shown as including six loops 1418 and / or five groups of tabs 1417, the flexure can include any number of loops 1418 and / or groups of tabs 1417.

[0177] In some embodiments, the flexure 1400 can be in an expanded and / or flexible state (e.g., Fig.14A and Fig. 14B ) and a contracted and / or rigid state (e.g., Figure 4 C). In the expanded and / or flexible state, one or more tabs 1417 can be configured to be attached to the rings 1418 at either side of the tab 1417 (e.g., at the first side 1427 and the second side 1428 of the tab 1417). One or more tabs 1417 can be configured to be at least partially detachable from at least one of the rings 1418. For example, as Fig. 14C As shown, the first side 1427 of the tab 1417 can be disconnected from any of the loops 1418, while the second side 1428 of the tab 1417 remains connected to one or more of the loops 1418. Thus, the tab 1417 can extend generally perpendicular to the length L of the flexure 1400 and / or can extend from any one and / or more sides of the flexure 1400. When the tab 1417 is at least partially removed from the loop 1418, the loop 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, as shown. Fig. 14C As shown. With the rings 1418 coupled together and / or placed in close proximity to each other, the flexure 1400 may have a more rigid structure. In some embodiments, one or more pull wires may be used to pull one or more distal rings 1418 to move the one or more rings 1418 together.

[0178] The tab 1417 may be connected to the ring 1418 in any suitable manner. For example, at least one side of the tab 1417 may form a releasable and / or detachable connection with the ring 1418. The releasable and / or detachable connection may be formed by a protrusion (e.g., a peg, a hook, a button, and / or a latch) extending from the tab 1417 and / or the ring 1418, which is configured to cooperate with an aperture, a notch, a hook, and / or other features at the ring 1418 and / or the tab 1417. In some embodiments, a pull wire and / or other device may be used to facilitate the removal of the tab 1417 from the ring 1418. In some embodiments, one or more tabs 1417 may form a removable connection with a first ring 1418 and / or may form a fixed connection with a second ring 1418. For example, as Fig. 14C As shown, the one or more tabs 1417 can remain coupled to the one or more rings 1418 on the second side 1428 while being detached from the one or more rings 1418 at the first side 1427 .

[0179] Fig.15 An example flexure 1500 including one or more rings 1518 and / or one or more springs 1550 engaging the one or more rings 1518 is illustrated according to one or more embodiments. In some embodiments, the delivery assembly may include the flexure 1500 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 1500 may similarly have a generally tubular form and / or may include an inner lumen. The flexure 1500 may be a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0180] The flexure 1500 may include a network of one or more loops 1518 interconnected by one or more springs 1550 and / or coils. The one or more springs 1550 may be configured to extend between the plurality of loops 1518 of the flexure 1500. In some embodiments, the loops 1518 may have a circular and / or cylindrical form.

[0181] In some embodiments, one or more rings 1518 can include a protrusion 1528 that is configured to mate with a corresponding notch 1529 and / or aperture of another ring 1518. Thus, one or more rings 1518 can be configured to engage together. For example, when one or more rings 1518 are pressed together (e.g., using one or more pull wires configured to apply tension and / or push forces to one or more rings 1518), one or more protrusions 1528 can be configured to slide into one or more notches and / or can form a secure attachment. Although Fig.15Although not shown in the figure, one or more pull wires may extend through the lumen and / or wall of the ring 1518 (e.g., see the Fig.26 ).

[0182] The flexure 1500 can be configured to selectively move between a first state (eg, an expanded and / or substantially flexible state) and a second state (eg, a compressed and / or substantially rigid state). Fig.15 An expanded and / or flexible state is shown. In the expanded state, there may be at least partial separation between the rings 1518 of the flexure 1500. One or more springs 1550 may be configured to interconnect the rings 1518 in the expanded state. After delivery through a narrow anatomical path and / or upon reaching the target tissue site, the rings 1518 may be brought together by any suitable means to move the flexure 1500 to a compressed state. In the compressed state, one or more springs 1550 may be at least partially compressed within the rings 1518.

[0183] In some embodiments, the flexure 1500 may include a single spring 1550 extending at least partially along the length of the flexure 1500. However, the flexure 1500 may include any number of springs 1550. For example, the flexure 1500 may include a spring 1550 for each pair of loops 1518.

[0184] Fig.16 An example flexure 1600 including one or more loops 1618 and / or one or more ropes 1617 and / or a rope net 1617 engaging the one or more loops 1618 is illustrated according to one or more embodiments. In some embodiments, the delivery assembly may include a flexure 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 1600 may similarly have a generally tubular form and / or may include an inner lumen. The flexure 1600 may be a part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0185] The flexure 1600 may include a network of one or more loops 1618 interconnected by one or more cords 1617 and / or cord bundles. The one or more cords 1617 may be configured to extend between adjacent loops 1618 of the flexure 1600. In some embodiments, the loops 1618 may have a circular and / or cylindrical form. For example, the loops 1618 may include a tubular piece of material.

[0186] The flexure 1600 can be configured to selectively move between a first state (eg, an expanded and / or substantially flexible state) and a second state (eg, a compressed and / or substantially rigid state). Fig.16 An expanded and / or flexible state is shown. In the expanded state, there may be at least partial separation between the rings 1618 of the flexure 1600. One or more cords 1617 may be configured to interconnect the rings 1618 in the expanded state. After delivery through a narrow anatomical path and / or upon reaching the target tissue site, the rings 1618 may be brought together by any suitable means to move the flexure 1600 to a compressed state. In the compressed state, one or more cords 1617 may be at least partially disposed within the rings 1618.

[0187] In some embodiments, a single rope 1617 and / or a network of ropes / rope bundles 1617 may be used. In some embodiments, a plurality of different ropes 1617 and / or rope bundles may be used to interconnect each pair of rings 1618.

[0188] One or more rings 1618 may include one or more protrusions 1622 configured to fit into and / or cooperate with corresponding recesses 1623, notches, and / or apertures of other rings 1618. For example, after the flexure 1600 is delivered to the target location, a force may be applied to one or more rings 1618 to move one or more rings 1618 closer together. The protrusions 1622 may fit into the recesses 1623 (e.g., similar to a puzzle piece) to allow the rings 1618 to move closer together and / or form a more secure connection between the rings 1618 in a rigid state.

[0189] Fig.17 At least a portion of an assembly 1700 including an example flexure 1707 according to one or more embodiments is illustrated, the example flexure including one or more rings 1718 and / or one or more springs 1717 engaging the one or more rings 1718. In some embodiments, the delivery assembly may include a flexure 1707 and / or a shaft 1705 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 1707 may similarly have a generally tubular form and / or may include an inner lumen. Assembly 1700 may be configured as an anchor delivery system or a portion / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0190] The flexure 1707 may include 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 the plurality of rings 1718 of the flexure 1707. In some embodiments, the rings 1718 may have a circular and / or cylindrical form. For example, the rings 1718 may include a tubular piece of material.

[0191] The flexure 1707 can be configured to selectively move between a first state (eg, an expanded and / or substantially flexible state) and a second state (eg, a compressed and / or substantially rigid state). Fig.17 An expanded and / or flexible state is shown. In the expanded state, there may be at least partial separation between the rings 1718 of the flexure 1707. 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 reaching the target tissue site, the rings 1718 may be brought together by any suitable means to move the flexure 1707 to a compressed state. In the compressed state, one or more springs 1717 may be at least partially compressed within the rings 1718.

[0192] In some embodiments, the flexure 1707 can include a single spring 1717 extending at least partially along the length of the flexure 1707. However, the flexure 1707 can include any number of springs 1717. For example, the flexure 1707 can include a spring 1717 between each pair of rings 1718.

[0193] Fig.18 At least a portion of an assembly including an example flexure 1800 according to one or more embodiments is illustrated, the example flexure comprising one or more sections including a first section 1801, a second section 1803, and / or a third section 1805. The second section 1803 may be at least partially disposed between the first section 1801 and the third section 1805 and / or may include one or more ropes 1817 that may be threaded together. The second section 1803 may be configured to engage the first section 1801 and the third section 1805. In some embodiments, the delivery assembly may include the flexure 1800 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 1800 may similarly have a generally tubular form and / or may include an inner lumen. In some embodiments, the flexure 1800 may be an intermediate portion and / or an end portion of the shaft. The flexure 1800 can be part of / component of an anchor delivery system (eg, any of the anchor delivery systems described herein).

[0194] The first segment 1801 and / or the third segment 1805 may include one or more wound filaments. In some embodiments, the second segment 1803 may include one or more cords forming the first segment 1801 and / or the third segment 1805 and / or may include a different cord.

[0195] In some embodiments, the second segment 1803 can 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 can be configured to move from a relatively flexible state to a relatively rigid state. For example, by pressing the third segment 1805 toward the first segment 1801 and / or pressing the first segment 1801 toward the third segment 1805, the second segment 1803 can be compressed to assume a more rigid state.

[0196] Fig.19 An example flexure 1900 including one or more interlocking teeth 1921 according to one or more embodiments is illustrated. In some embodiments, a delivery assembly may include a flexure 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 1900 may similarly have a generally tubular form and / or may include an inner lumen. The flexure 1900 may be part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0197] The flexure 1900 may include any number of teeth 1921 and / or the teeth 1921 may have any suitable shape and / or size. In some embodiments, the teeth 1921 may be configured to fit together in a puzzle piece manner. For example, the first section 1918 may include one or more teeth 1921 configured to mate with corresponding teeth 1921 of the second section 1919. Fig.19 As shown, the teeth 1921 may include a T-shaped protrusion from each segment. However, the teeth 1921 may have other shapes. In some embodiments, the first segment 1918 and the second segment 1919 may have substantially equal sizes and / or shapes that may be staggered so that the protrusion at the first segment 1918 fits into the recess of the second segment 1919 and / or vice versa. The teeth 1921 of one or more segments may extend around the entire circumference of the flexure 1900.

[0198] The flexure 1900 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). In the expanded state, there may be at least a partial separation between the teeth 1921 of adjacent sections of the flexure 1500. After delivery through a narrow anatomical path and / or upon reaching the target tissue site, the teeth 1921 may be brought together by any suitable means to move the flexure 1900 to a compressed state. In the compressed state, one or more teeth 1921 may be locked together and / or may be more tightly engaged than in the expanded state. In some embodiments, the teeth 1921 may include locking features (e.g., pegs and / or notches) configured to provide a secure attachment between the teeth 1921.

[0199] Figure 20 Figure 20-1 and Figure 20-2 ) is a flow chart illustrating steps of an example method or process 2000 for delivering one or more tissue anchors via a shaft including a flexure according to one or more embodiments. FIG. 21 ( Figure 21-1 and Figure 21-2 ) provides example images corresponding to the steps of method / process 2000 of Figure 20.

[0200] At step 2002, process 2000 includes 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 a tricuspid valve 6 delivery process is illustrated in FIG. 21, the steps of process 2000 may be applicable to delivery at various tissue sites including the mitral valve. The delivery shaft 2105 may be part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0201] The delivery shaft 2105 may include a flexure 2133 that includes any of a variety of features for facilitating the transition of the delivery shaft from a first state to a second state (e.g., a compressed and / or rigid state) and / or from a second state to a first state. For example, as shown in image 2102, the flexure 2133 may include one or more rings 2118 interconnected by one or more tabs 2117. However, the flexure may have any of the various features described herein with respect to the flexure. The shaft 2105 and / or the flexure 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).

[0202] At step 2004, process 2000 includes modifying the delivery shaft 2105 and / or flexure 2133 from a first state to a second state (e.g., a compressed and / or rigid state). In some embodiments, the flexure 2133 may include one or more tabs 2117 configured to at least partially disconnect and / or detach from one or more rings 2118 to allow the one or more rings 2118 to engage together and / or move into close proximity with each other, as shown in image 2104 of FIG. 21. Other example flexures 2133 may include springs, cords, interlocking teeth, and / or other features configured to facilitate transition of the shaft 2105 from a first state to a second state and / or vice versa.

[0203] In the embodiment shown in image 2104, tabs 2117 may each be disconnected from ring 2118 on one side and / or may extend generally vertically and / or axially from shaft 2105 and / or tissue anchor 2112. Thus, ring 2118 may be allowed to fill the space previously occupied by tab 2117. When in the first state shown in image 2102, tab 2117 may extend generally in line with shaft 2105 and / or may allow for improved flexibility of shaft 2105. For example, one or more tabs 2117 may serve as a hinge and / or may include a flexible structure that may facilitate bending of shaft 2105. In some embodiments, ring 2118 may include a generally rigid and / or solid material and / or may have minimal flexibility. When in the second state illustrated in image 2104, one or more rings 2118 may be joined together and / or may close gaps between rings 2118. Thus, the rigidity of ring 2118 may provide flexure 2133 with a generally rigid structure.

[0204] The shaft 2105 may also include one or more proximal segments 2131 extending between the flexure 2133 and the handle and / or other proximal device. 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 embodiments, at least a portion of the one or more proximal segments 2131 adjacent to the flexure 2133 may be at least partially flexible to allow the shaft 2105 to bend, as shown in image 2104.

[0205] At step 2006, process 2000 includes driving one or more tissue anchors 2112 into tissue using delivery shaft 2105 and / or flexure 2133 when flexure 2133 is in the second state, as shown in image 2106 of FIG21. In some embodiments, the increased rigidity of shaft 2105 due to flexure 2133 being in the second state can facilitate driving tissue anchors 2112 into tissue. For example, flexure 2133 may not bend in response to driving pressure from shaft 2105 and into flexure 2133.

[0206] Fig.22A and Fig. 22B At least a portion of an example delivery shaft 2205 is illustrated including a flexure that includes one or more springs extending across a break in the delivery shaft 2205 in accordance with one or more embodiments. In some embodiments, the delivery shaft 2205 can include a driver 2212 at a distal end of the delivery shaft 2205 that is configured to drive one or more tissue anchors into a target tissue location (e.g., at or around one or more valves of the heart). The driver 2212 can 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 can be part / component of an anchor delivery system (e.g., any of the anchor delivery systems described herein).

[0207] In some embodiments, the delivery shaft 2205 can include a flexure at or near the driver 2212 and / or the distal end of the delivery shaft 2205. The flexure can be configured to facilitate changing from a first state (e.g., a generally linear and / or continuous state) to a second state (e.g., a generally curved and / or discontinuous state) and / or from the second state to the first state.

[0208] The flexure may include a break 2252 and / or a cutout in the delivery shaft 2205. In some embodiments, the break 2252 may include a cutout through the shaft 2205 that separates the shaft into a proximal section 2206 and a distal section 2208. Fig.22A and Fig. 22B 2205, but the break 2252 can be any type of cut and / or can have any angle.

[0209] In some embodiments, the flexure can include one or more springs 2250 and / or the like extending across the break 2252 and / or at least partially disposed within the proximal segment 2206 and the distal segment 2208. The one or more springs 2250 can be configured to form a bridge between the proximal segment 2206 and the distal segment 2208 and / or press the proximal segment 2206 and the distal segment 2208 into contact with each other. The one or more springs 2250 can be configured to assume a resting, relaxed, and / or compressed form when the proximal segment 2206 and the distal segment 2208 are in continuous and / or linear alignment, such as Fig.22A shown.

[0210] like Fig. 22BAs shown, the one or more springs 2250 can be configured to expand and / or twist 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 each other and / or are not aligned. 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 form to extend across any gap between the proximal segment 2206 and the distal segment 2208.

[0211] In some embodiments, the shaft 2205 can have a default and / or natural alignment of the proximal section 2206 and the distal section 2208. For example, the proximal edge 2221 of the proximal section 2206 can be configured to align with the distal edge 2223 of the distal section 2208, and / or the proximal section 2206 and the distal section 2208 can naturally contact. In the first state, the proximal edge 2221 and the distal edge 2223 can contact each other and / or be in close proximity. One or more springs 2250 can be configured to maintain the alignment of the proximal section 2206 and the distal section 2208. Therefore, the one or more springs 2250 can be configured to resist misalignment of the proximal section 2206 and the distal section 2208. For example, if a torsional force is applied to the proximal segment 2206, the one or more springs 2250 may be configured to maintain alignment and / or resist twisting of the proximal segment 2206 out of alignment with the distal segment 2208. If the proximal segment 2206 and / or the distal segment 2208 are twisted out of alignment, the one or more springs 2250 may 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.

[0212] The flexures can be configured to provide torque limiting at the distal end and / or distal portion 2208 of the shaft 2205. For example, the flexures can be configured to provide a measurement and / or reading when the amount of torque at the distal portion 2208 of the shaft 2205 exceeds a given amount. The flexures can be designed to become misaligned when the distal portion 2208 of the shaft 2205 reaches a desired and / or set maximum torque level.

[0213] Although the shaft 2305 is shown as including an angled break 2252 (e.g., a break and / or cutout of approximately 45 degrees), the break 2252 may have a different angle and / or may be substantially vertical. One or more coils 2250 and / or springs may be configured to maintain the proximal segment 2206 and the distal segment 2208 aligned when the shaft 2205 is twisted until the twisting causes the torque of the distal segment 2208 to exceed a predetermined level. For example, one or more coils 2250 may be configured to transfer torque from the proximal segment 2206 to the distal segment 2208. In some embodiments, 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 the transfer of torque 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, ridges, and / or other protrusions configured to mate with corresponding notches and / or indentations at the distal segment 2208 and / or the proximal segment 2206 .

[0214] The flexures may be configured to facilitate various methods of testing the extent to which a tissue anchor is anchored into tissue. For example, after the shaft 2205 has been at least slightly twisted to at least partially embed the tissue anchor at the distal end of the shaft 2205 into the tissue, the surgeon may axially pull back the shaft 2205 and / or the proximal section 2206 of the shaft 2205. The amount of resistance presented by the distal section 2208 may indicate the extent to which the tissue anchor is embedded and / or may be reflected by the ease with which the proximal section 2206 is pulled away from the distal section 2208 to create a gap 2252 between the proximal section 2206 and the distal section 2208. For example, if the distal section 2208 remains in place when the proximal section 2206 is pulled away from the distal section 2208 and / or a predetermined amount of separation is achieved before the distal section 2208 is pulled out, the tissue anchor may be properly embedded and further anchoring may not be required. In contrast, if the distal section 2208 is pulled away from the tissue along with the proximal section 2206 and / or does not provide an appropriate amount of resistance when the proximal section 2206 is pulled, further anchoring may be required.

[0215] In some embodiments, the break 2252 can be configured to allow at least partial separation between the proximal section 2206 and the distal section 2208 during delivery of the shaft 2205 to a target tissue location. For example, the break 2252 can be widened to allow increased bending of the shaft 2205 as the shaft 2205 moves around a bend in the patient's anatomy. The shaft 2205 can be constructed at least in part from a braided cable to allow some flexibility of the shaft 2205. Additionally, the thickness of the shaft 2205 can be variable across the shaft 2205 as desired to facilitate delivery of the shaft 2205. For example, the shaft 2205 can have a reduced thickness at or near the flexure and / or distal portion of the shaft 2205 to facilitate bending of the flexure and / or distal portion.

[0216] Fig.23A and Fig. 23B The process of driving one or more tissue anchors 2302 into tissue 10 is illustrated in accordance with one or more embodiments. In some embodiments, the shaft 2305 may include a driver 2312 configured to connect with the tissue anchor 2302 (e.g., at the head 2380 portion of the anchor 2302) to twist and / or press the tissue anchor 2302 into the tissue. The shaft 2305 may include a flexure portion including one or more springs 2350 bridging a break 2352 in the shaft 2305. The break 2352 may represent a separation between the proximal segment 2306 and the distal segment 2308 of the shaft 2305. During delivery and / or before the tissue anchor at the distal end of the shaft 2305 is fully embedded, the contact between the proximal segment 2306 and the distal segment 2308 may be flush. The driver 2312 and / or shaft 2305 and associated features may be configured as an anchor delivery system (which may be similar to other anchor delivery systems described herein) or a portion / component of an anchor delivery system.

[0217] In some embodiments, the shaft 2305 can be configured to twist to cause a corresponding twist of the driver 2312 and / or the tissue anchor 2302. In some embodiments, the tissue anchor 2302 can include a coil 2327 configured to embed into the tissue 10 when the tissue 10 is twisted. Thus, when the shaft 2305 is twisted, the tissue anchor 2302 can further embed into the tissue 10, such as Fig. 23B shown.

[0218] When at least a portion of the tissue anchor 2302 (e.g., the coil of the tissue anchor 2302) is fully embedded in the tissue 10, the base portion of the tissue anchor 2302 can be pressed against the tissue 10 and / or the tissue anchor 2302 can provide an increased amount of resistance to the driver 2312 and / or the shaft 2305. This increased resistance can cause the distal section 2308 of the shaft 2305 to resist further twisting.

[0219] The proximal portion 2306 may be disposed between the distal segment 2308 and a handle and / or other control mechanism. Force from the handle and / or other control mechanism may be transferred first to the proximal segment 2306 and then to the distal segment 2308 via one or more springs 2350 and / or friction between the proximal segment 2306 and the distal segment 2308. When the distal segment 2308 presents increased resistance due to the tissue anchor 2302 being fully and / or at least partially embedded in the tissue 10, torsion of the proximal segment 2306 may not be transferred to torsion of the distal segment 2308. Therefore, the proximal segment 2306 may twist without being aligned with the distal segment 2308, as shown in FIG. Fig. 23B shown.

[0220] When the proximal segment 2306 is twisted out of alignment with the distal segment 2308, the break 2352 between the proximal segment 2306 and the distal segment 2308 may at least partially widen and / or one or more gaps may be formed between the proximal segment 2306 and the distal segment 2308. In addition, the proximal edge 2321 of the proximal segment 2306 may move out of contact with and / or alignment with the distal edge 2323 of the distal segment 2308.

[0221] In some embodiments, the flexure of the shaft 2305 can be at least partially visible to the surgeon via any suitable viewing device and / or the like. Thus, when the proximal section 2306 and the distal section 2308 move out of alignment, the surgeon can see and / or notice the misalignment. Using this information, the surgeon and / or the drive mechanism can stop applying the drive force and / or can separate the shaft 2305 and / or the driver 2312 from the tissue anchor 2302. In some embodiments, the flexure can be configured to act as a slip clutch and / or can be configured to prevent the application of a torque exceeding a configured threshold.

[0222] Various factors that determine how much torque can be applied before the shaft 2305 reaches deformation and / or becomes misaligned may include the strength of the coil 2350 and / or the surface characteristics (e.g., coefficient of friction) between the proximal section 2306 and the distal section 2308. The shaft 2305 may be calibrated based on how much torque may be required to drive the tissue anchor into the tissue. The flexures may be configured to limit the force applied in the torque direction and / or in the push / pull and / or linear directions.

[0223] The inclined and / or angled break 2352 can be configured to facilitate testing torque and / or linear direction. For example, the break 2352 can be configured to cause deformation due to excessive torque and / or tension. The separation of the proximal segment 2306 and the distal segment 2308 can be identified in any suitable manner, which may include fluoroscopic examination and / or electronic means. In some embodiments, the break 2352 can be inclined and / or spiral.

[0224] The friction along the length of the shaft 2305 may depend on and / or may be determined based at least in part on 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 at the shaft 2305. In some cases, the catheter around the shaft 2305 may constrain the shaft 2305 to a certain extent and / or may help prevent and / or inhibit the shaft 2305 from shaking and / or otherwise moving out of alignment and / or may hold the shaft 2305 in place, which may accumulate friction at the shaft 2305. Wherever the outer catheter resists movement of the shaft 2305, some torque at the shaft 2305 may be lost.

[0225] Fig.24 An example shaft 2405 including a flexure portion is illustrated according to one or more embodiments. The shaft 2405 can be a component / portion of an anchor delivery system (e.g., similar to other anchor delivery systems described herein). The flexure portion can include one or more coils 2450 that are at least partially disposed within the shaft 2405 and / or are configured to extend between a distal segment 2408 and a proximal segment 2406 of the shaft 2405. The flexure portion can also 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 in the shaft 2405, such as Fig.24 However, the break 2452 may include a diagonal cut and / or may have any suitable angle.

[0226] In some embodiments, the shaft 2405 and / or the flexure portion may include one or more edge portions that may protrude from the shaft 2405. For example, the proximal segment 2406 may include a first edge portion 2421 and / or the distal segment 2408 may include a second edge portion 2432. The first edge portion 2421 and / or the second edge portion 2432 may be disposed at either side of the break 2452 and / or may be configured to contact each other in a stationary state of the shaft 2405. For purposes of illustration, the shaft 2405 is Fig.242406 and the distal section 2408. However, one or more coils 2450 and / or springs may be configured to pull the proximal section 2406 and the distal section 2408 together so that the first edge portion 2421 and the second edge portion 2432 are in contact in a static and / or default state.

[0227] The shaft 2405 can be configured to twist 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 the 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.

[0228] Fig.25A and Fig.25B An example delivery device 2500 for delivering one or more catheters and / or medical devices to a target location in the body according to one or more embodiments is illustrated. The delivery device 2500 may be configured as an anchor delivery system (which may be similar to other anchor delivery systems herein) or a portion / component of an anchor delivery system. The delivery device 2500 may include a plurality of handles and / or engagement mechanisms, including a first handle 2511 and / or a second handle 2513. The first handle 2511 may be configured to extend and / or control the extension of a wire 2520 (e.g., a nitinol wire) and / or a medical implant through an outer catheter 2505 and / or an inner catheter 2515. The second handle 2513 may be configured to extend and / or control the extension of one or more pull wires. One or more pull wires may be at least partially disposed within the outer catheter 2505 and / or the inner catheter 2515, and / or may be configured to facilitate the movement of one or more flexures at the outer catheter 2505 and / or the inner catheter 2515 from an expanded and / or flexible state to a compressed and / or rigid state. Fig.25A The device 2500 is illustrated in a first state, wherein the first handle 2511 has not yet been engaged to cause extension and / or protrusion of the wire 2520. Fig.25B A second state of the device 2500 is illustrated, wherein the first handle 2511 has been pressed toward the second handle 2513 to cause extension and / or protrusion of the wire 2520 relative to the outer catheter 2505 and / or the inner catheter 2515.

[0229] Fig.26An example flexure 2600 including one or more pull wires 2630 according to one or more embodiments is illustrated, and the one or more pull wires are configured to control the positioning of one or more rings 2618 and / or one or more springs 2650 engaging the one or more rings 2618. In some embodiments, the delivery assembly may include a flexure 2600 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 transmission of one or more wires and / or tissue anchors. The flexure 2600 may similarly have a generally tubular form and / or may include an inner lumen. The flexure 2600 may be a part / component of an anchor delivery system (which may be the same or similar to other anchor delivery systems herein).

[0230] The flexure 2600 may include a network of one or more loops 2618 interconnected by one or more springs 2650 and / or coils. The one or more springs 2650 may be configured to extend between the plurality of loops 2618 of the flexure 2600. In some embodiments, the loops 2618 may have a circular and / or cylindrical form.

[0231] In some embodiments, one or more rings 2618 can include a protrusion 2628 that is configured to mate with a corresponding notch 2629 and / or aperture of another ring 2618. Thus, one or more rings 2618 can be configured to engage together.

[0232] The flexure 2600 can be configured to selectively move between a first state (eg, an expanded and / or substantially flexible state) and a second state (eg, a compressed and / or substantially rigid state). Fig.26 An expanded and / or flexible state is shown. In the expanded state, there may be at least partial separation between the rings 2618 of the flexure 2600. One or more springs 2650 may be configured to interconnect the rings 2618 in the expanded state. After delivery through a narrow anatomical path and / or upon reaching the target tissue site, the rings 2618 may be brought together by any suitable means to move the flexure to a compressed state. In the compressed state, one or more springs 2650 may be at least partially compressed within the rings 2618.

[0233] In some embodiments, the flexure 2600 may include a single spring 2650 extending at least partially along the length of the flexure 2600. However, the flexure 2600 may include any number of springs 2650. For example, the flexure 2600 may include a spring 2650 for each pair of rings 2618.

[0234] The flexure 2600 and / or a delivery device for delivering the flexure 2600 may include one or more pull wires 2630 configured to extend at least partially through one or more loops 2618 to control the position of the one or more loops 2618 relative to each other. For example, the one or more pull wires 2630 may be passed through an orifice of a loop 2618 and / or may be pulled to pull the distal loop 2618 toward the proximal loop 2618. By pulling the loops 2618 together, the one or more pull wires 2630 may be configured to facilitate movement of the flexure 2600 from a flexible and / or expanded state to a compressed and / or rigid state.

[0235] The flexure 2600 is shown as including a first pull wire 2630a and a second pull wire 2630b. However, the flexure 2600 and / or the delivery device may include any number of pull wires 2630. For example, the flexure 2600 and / or the delivery device may include four pull wires 2630. In some embodiments, two pull wires 2630 may be disposed on substantially opposite sides of the loop 2618, such as Fig.26 In some embodiments, one or more pull wires 2630 can be configured to extend through each loop 2618 of the flexure 2600. However, one or more pull wires 2630 can be configured to extend through only a portion of the flexure 2600.

[0236] According to one or more embodiments of the present disclosure, a method for delivering one or more tissue anchors includes delivering an elongated shaft carrying one or more tissue anchors at a distal end of the elongated shaft to a target tissue location. The elongated shaft includes a flexure configured to move between a first state and a second state. The method may also include moving the flexure from the first state to the second state to facilitate driving the one or more tissue anchors into the target tissue location, and moving the flexure from the second state to the first state.

[0237] Moving the flexure from the first state to the second state may include compressing the flexure. In some embodiments, moving the flexure from the first state to the second state includes twisting the elongated shaft until a gap is formed in the flexure.

[0238] In some embodiments, the flexure comprises at least one detachable tab between segments of the flexure.The segments may be annular.

[0239] The flexure may comprise a network of interlocking teeth.In some embodiments, the flexure comprises a coil extending through a lumen of the flexure.

[0240] In some embodiments, the coil is configured to interconnect segments of the flexure.The flexure may include a cutout through the elongated shaft.

[0241] Moving the flexure portion from the first state to the second state includes pulling one or more pull wires extending at least partially through the flexure portion.

[0242] The above methods can be performed on a living animal or a simulated object, such as a cadaver, a cadaver heart, a simulated object (eg, a simulated body part, heart, tissue, etc.), and the like.

[0243] Some embodiments of the present disclosure are directed to a system for delivering one or more tissue anchors, the system comprising an elongated shaft carrying the one or more tissue anchors at a distal end thereof to a target tissue location. The elongated shaft comprises a flexure portion configured to move between a first state and a second state.

[0244] 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.

[0245] The flexure may be configured to move from the first state to the second state by compressing the flexure.In some embodiments, the flexure is configured to form a gap in response to torsion of the elongated shaft.

[0246] In some embodiments, the flexure comprises at least one detachable tab between segments of the flexure.The segments may be annular.

[0247] The flexure may comprise a network of interlocking teeth.In some embodiments, the flexure comprises a coil extending through a lumen of the flexure.

[0248] In some embodiments, the coil is configured to interconnect segments of the flexure.The flexure may include a cutout through the elongated shaft.

[0249] The system may also include one or more pull wires configured to extend at least partially through the flexure portion. In some embodiments, the one or more pull wires extend at least partially through multiple sections of the flexure portion.

[0250] Sterilization

[0251] Any of the various systems, devices, equipment, 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 patients, and any of the methods herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) as one of the steps of the method.

[0252] Compressible Anchor Driver

[0253] FIG. 27A to FIG. 27C An example anchor delivery system 2700 constructed for delivering one or more tissue anchors according to one or more examples is illustrated. 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., reinforcing components, steering components, softening components, flexible components, etc.) or features. The anchor delivery system may include a portion or component (e.g., an outer shaft, an inner shaft, a rod, a wire, an extension, etc.) that moves (e.g., axially, rotationally, etc.) relative to another portion or component (e.g., an outer shaft, an inner shaft, a rod, a wire, an extension, etc.) to change one or more of the hardness, rigidity, softness, flexibility, etc. of the anchor delivery system.

[0254] In some embodiments, the system 2700 can be configured to extend the outer shaft 2715 of the system 2700 without twisting the outer shaft 2715. The outer shaft 2715 may not be required to resist torque loads. For example, torque accumulation at the distal end of the outer shaft 2715 can cause adhesion of the outer shaft 2715 and / or one or more anchors connected to the distal end of the outer shaft 2715. The system 2700 may additionally include an inner shaft 2717. The outer shaft 2715 and / or the inner shaft 2717 can be coupled to a holder (not shown; see, e.g., Fig.11 ).

[0255] In some embodiments, the outer shaft 2715 and / or the inner shaft 2717 can be configured to receive one or more wires 2710 (eg, nitinol wires). FIG. 27A to FIG. 27C Only a single wire 2710 is shown in the system 2700, but the system 2700 may include any number of wires 2710. In some embodiments, one or more wires 2710 may be configured to move the flexures of the outer shaft 2715 and / or the inner shaft 2717 between multiple states. For example, one or more wires 2710 may include a pull wire that is configured to be selectively tensioned to cause movement of the flexures of various shafts and / or catheters.

[0256] In some embodiments, the outer shaft 2715 and / or the inner shaft 2717 may include a laser cut hypotube and / or similar components. In some embodiments, the outer shaft 2715 and / or the inner shaft 2717 may include one or more drill bits and / or similar devices at the distal end of the outer shaft 2715 and / or the inner shaft 2717, which are configured to cooperate with the clamp at the distal end of the system 2700. Torsion of the outer shaft 2715 and / or the inner shaft 2717 may cause bonding problems at the clamp and / or other areas. Such bonding problems may be caused by metal-to-metal contact between the metal clamp and / or the metal outer shaft 2715 and / or the inner shaft 2717. In some embodiments, the system 2700 may advantageously not require torsion of the outer shaft 2715 and / or may include a longitudinal extension of the outer shaft 2715 with minimal or no torque on the outer shaft 2715. The system 2700 may further advantageously prevent unnecessary and / or excessive compression of the inner shaft 2717 .

[0257] In some embodiments, the outer shaft 2715 and / or the inner shaft 2717 can be welded to the holder to secure the holder and / or the distal end of the system 2700 in place. In some embodiments, the system 2700 can include a nut 2712 (e.g., a screw, bolt, and / or threaded member) configured to apply force and / or compression to the button 2714 and / or the outer shaft 2715. In some embodiments, the outer shaft 2715 can be coupled to the button 2714. In some embodiments, the nut 2712 can be threaded and / or can be configured to twist along the threaded surface of a set screw 2719 (e.g., a threaded screw).

[0258] The torsion and / or torque of the nut 2712 may not be transferred to the knob 2714 and / or the outer shaft 2715. For example, the nut 2712 may be configured to slide along the surface of the knob 2714 to press the knob 2714 without generating a corresponding torsion in the knob 2714. In some embodiments, the system 2700 may include a washer and / or a sliding member (e.g., a bearing surface, a Teflon washer, etc.) between the nut 2712 and the knob 2714 to prevent the friction torque from being transferred from the nut 2712 to the knob 2714. The nut 2712 may not be attached to the outer shaft 2715. The knob 2714 may be configured not to twist in response to the force applied from the nut 2712.

[0259] In some embodiments, the knob 2714 can include a channel 2720 configured to receive a pin 2721 and / or a protrusion extending from the inner shaft 2717. The pin 2721 can be configured to prevent rotation and / or extension of the knob 2714. The channel 2720 can have a generally rectangular shape and / or can include a recess and / or a cavity through the knob 2714. The inner shaft 2717 can be configured to extend at least partially through the knob 2714 and / or the screw 2719.

[0260] like Fig.27B As shown, in some embodiments, rotation of nut 2712 (e.g., clockwise and / or counterclockwise rotation) can cause the nut to extend axially along set screw 2719. For example, nut 2712 can be configured to slide and / or glide along the threads of set screw 2719. In some embodiments, movement and / or extension of nut 2712 along screw 2719 can be configured to cause corresponding movement and / or extension of knob 2714. For example, nut 2712 can be configured to press against knob 2714 and / or apply axial force and / or pressure to knob 2714. Knob 2714 can be configured not to twist in response to the force applied by nut 2712.

[0261] In some embodiments, the system 2700 may include one or more arms 2726 that are coupled to the nut 2712 and / or the knob 2714 and / or are configured to form one or more bridges between the nut 2712 and the knob 2714. For example, the knob 2714 may include one or more pegs 2728 that may include any knobs, recesses, and / or other protrusions that are configured to be grasped and / or otherwise engaged by the one or more arms 2726. In some embodiments, the one or more pegs 2728 may include an elliptical extension extending from the knob 2714 around the entire circumferential surface of the knob 2714, and / or may include one or more discrete protrusions that are configured to engage with discrete arms 2726 coupled to the nut 2712. Although FIG. 27A to FIG. 27C A peg 2728 is illustrated extending from the knob 2714 , but the knob 2714 may additionally or alternatively include one or more cavities, apertures, and / or recesses configured to receive corresponding protrusions from one or more arms 2726 .

[0262] In some embodiments, one or more arms 2726 can be configured to apply a push and / or pull force to one or more pegs 2728. For example, when the nut 2712 is extended, one or more arms 2726 can be configured to apply a force to the proximal surface of one or more pegs 2728. Similarly, when the nut 2712 is extended, Fig.27CWhen rotated in the opposite direction as illustrated, the nut 2712 can be retracted and / or can be configured to apply a pulling force to the distal surface of one or more pegs 2728. In some embodiments, one or more arms 2726 can include a proximal wall and / or a distal wall and / or a protrusion configured to engage the proximal side and / or distal side of the peg 2728, respectively. In some embodiments, one or more arms 2726 can include a hollow spherical extension configured to surround one or more pegs 2728.

[0263] In some embodiments, the system 2700 can include a stop 2722 (e.g., a stop nut) configured to prevent the nut 2712 from retracting beyond a certain point along the screw 2719. For example, the stop 2722 can be disposed along the screw 2719 between the nut 2712 and the handle 2718. The system 2700 can include a handle nut 2724 disposed between the screw 2719 and the handle 2718.

[0264] FIG. 28A to FIG. 28D An example flexure 2800 of a delivery catheter according to one or more embodiments is illustrated. The delivery catheter may be an anchor delivery system (which may be similar to other anchor delivery systems herein) or a portion / component of an anchor delivery system. In some embodiments, the flexure 2800 may include one or more pull wires 2830, which are configured to control the positioning of one or more segments 2818 (e.g., rings) of the flexure 2800. In some embodiments, the delivery assembly may include a flexure 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 delivery of one or more wires and / or tissue anchors. The flexure 2800 may similarly have a generally tubular form and / or may include an inner lumen. In some embodiments, the flexure 2800 may include a network of one or more segments 2818 interconnected by one or more pull wires 2830. In some embodiments, the segment 2818 may have a circular and / or cylindrical form.

[0265] In some embodiments, one or more segments 2818 can include a protrusion 2828 configured to mate with a corresponding recess 2829 and / or aperture of another segment 2818. Thus, one or more segments 2818 can be configured to be joined together and / or interconnected.

[0266] In some embodiments, the flexure 2800 can be configured to selectively move between a plurality of states, including Fig.28A The illustrated open state (eg, expanded and / or generally flexible state), Fig.28B The closed state (eg, compressed and / or substantially rigid state) illustrated, Fig.28CThe illustrated bending states and / or Fig.28D The zigzag state illustrated. In the expanded state, there may be at least partial separation between the segments 2818 of the flexure 2800. One or more pull wires 2830 may be configured to interconnect the segments 2818 in the expanded state. After delivery through a narrow anatomical path and / or upon reaching the target tissue site, the segments 2818 may be brought together by any suitable means to move the flexure 2800 to a compressed state.

[0267] In some embodiments, the transition between the various states of the flexure 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 press and / or pull, for example, the distal segment 2818a toward the proximal segment 2818b and / or to move the segments 2818 together. In order to move all of the segments 2818 together, multiple pull wires 2830 can be tensioned and / or pulled simultaneously and / or in a synchronized manner so that all of the pull wires 2830 apply a force to the segments 2818 to cause the segments 2818 to move toward each other. Thus, the flexure 2800 can be moved to Fig.28B The compressed form shown.

[0268] In some embodiments, 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. Thus, the second pull wire 2830 may cause the segments 2818 to engage at one side of the flexure 2800, and / or the first pull wire 2830a may allow spacing between the segments 2818 at the other side of the flexure 2800. The flexure 2800 may form a bend toward the second pull wire 2830b, such as Fig.28C shown.

[0269] The relaxation and / or absence of tension in one or more pull wires 2830 can allow the flexure 2800 to bend and / or migrate in various directions. For example, the flexure 2800 can form a zigzag shape, wherein the distal segment 2818a and the proximal segment 2818b can face different directions, such as Fig.28D The flexure 2800 can be configured to move in response to movement of an anatomical structure in contact with the flexure 2800 to allow the flexure 2800 to maintain contact with the anatomical structure and / or one or more anchors anchored therein as the anatomical structure moves.

[0270] In some embodiments, one or more pull wires 2830 can be configured to extend at least partially through one or more segments 2818 to control the position of one or more segments 2818 relative to each other. For example, one or more pull wires 2830 can be passed through an orifice of a segment 2818 and / or can be pulled to pull the distal segment 2818 toward the proximal segment 2818. By pulling the segments 2818 together, one or more pull wires 2830 can be configured to facilitate movement of the flexure 2800 from a flexible and / or expanded state to a compressed and / or rigid state.

[0271] The flexure 2800 is shown to include a first pull wire 2830a, a second pull wire 2830b, and / or additional pull wires 2830. However, the flexure 2800 and / or the delivery device may include any number of pull wires 2830. For example, the flexure 2800 and / or the delivery device may include four pull wires 2830. In some embodiments, two pull wires 2830 may be disposed on substantially opposite sides of a segment 2818, as shown in FIG. 28. In some embodiments, one or more pull wires 2830 may be configured to extend through each segment 2818 of the flexure 2800. However, one or more pull wires 2830 may be configured to extend through only a portion of the flexure 2800.

[0272] Figure 29 Figure 29-1 and Figure 29-2 ) provides a flow chart illustrating an example method or process 2900 for actuating one or more tissue anchors and / or for evaluating one or more tissue anchors according to one or more embodiments. FIG. 30 ( Figure 30-1 and Figure 30-2 ) provides images associated with the steps of process 2900 of Figure 29.

[0273] In some embodiments, at step 2902, the method / process 2900 includes compressing the catheter 3001 (e.g., the elongated shaft) and / or other delivery devices and / or a flexure of the catheter 3001 to facilitate driving one or more anchors 3005 into tissue via the catheter 3001, as shown in image 3000a of FIG. 30. The catheter 3001 can be configured as an anchor delivery system (which can be similar to other anchor delivery systems described herein) or can be a part / component of an anchor delivery system. The catheter 3001 can be configured to move between multiple states and / or can include multiple forms. For example, during delivery through the body, the catheter 3001 can be configured to assume a generally flexible form (see, e.g., Fig.28A and / or Fig.28D). The catheter 3001 may include one or more pull wires 3030 configured to control the positioning of the various segments 3018 of the catheter 3001 relative to each other. During delivery, the one or more pull wires 3030 may have a generally relaxed state and / or may be configured to allow the segments 3018 to move independently of other segments 3018 and / or to allow gaps to form between the segments 3018. The catheter 3001 may include any number of segments 3018 and / or may include two or more segments 3018.

[0274] 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 chambers. The flexure 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 the sections 3018 of the catheter 3001. The pull wire 3030 can be released to move the flexure of the catheter 3001 from the compressed state to the flexible state. The catheter 3001 can be configured to carry one or more tissue anchors and / or engage one or more tissue anchors (e.g., at the distal end of the catheter 3001).

[0275] When the target tissue site is reached, one or more pull wires 3030 can be tensioned and / or pulled to draw the segments 3018 together and / or move the catheter 3001 to a generally compressed and / or rigid form. The rigid form of the catheter 3001 can allow the catheter 3001 to resist bending and / or twisting when the anchor 3005 is driven into the tissue (e.g., into the valve leaflet 10). In some embodiments, the anchor 3005 can be configured to anchor the prosthetic leaflet 3003 and / or the like.

[0276] The catheter 3001 may be configured to not bow and / or bend when in the compressed form shown in image 3000a. For example, the drive pressure may be applied to the catheter 3001 without the catheter 3001 and / or the flexure of the catheter 3001 bending.

[0277] In some embodiments, at step 2904, the method / process 2900 includes releasing wire tension of one or more pull wires 3030 of the catheter 3001 to allow at least partial expansion of the catheter 3001, as shown in image 3000b of Figure 30. For example, the catheter 3001 and / or a flexure of the catheter 3001 may bend in response to the release of the wire tension.

[0278] In some embodiments, at step 2906, the method / process 2900 includes maintaining contact between the catheter 3001 and / or the flexure and / or the distal end of the catheter 3001 and the anchor 3005 to assess retention and / or anchoring of the anchor 3005 to the native tissue and / or the leaflets 3003, as illustrated in image 3000c of Fig. 30. For example, the catheter 3001 and / or the distal end of the catheter 3001 can be configured to move with the anchor 3005, the prosthetic leaflets 3003, and / or the tissue 10 while maintaining contact between the catheter 3001 and the anchor 3005.

[0279] If it is determined that the anchoring of the anchor 3005 is incomplete, the catheter 3001 and / or the flexure of the catheter 3001 may be advantageously compressed and / or tensioned to allow further actuation of the anchor 3005 without reattaching the catheter 3001 to the anchor 3005. For example, one or more pull wires 3030 may be in a flexible and / or untensioned state to allow the catheter 3001 to move and / or may be tensioned to restore the compressed and / or rigid form of the catheter 3001. In a flexible state, the flexure of the catheter 3001 may be configured to freely swing in rhythm with external forces and / or in various directions (e.g., complex three-dimensional and / or circular movement).

[0280] If anchoring of anchor 3005 is determined to be adequate, catheter 3001 and / or the flexure of catheter 3001 may be removed from anchor 3005 and / or may be moved to a different position to facilitate driving a second anchor into prosthetic leaflet 3003, tissue 10 and / or other target location.

[0281] The catheter 3001 may be configured to selectively assume a stiff and / or soft state to assist in various stages of delivery and / or anchor actuation. The catheter 3001 may be configured for use in transcatheter procedures. In some embodiments, the catheter 3001 may be configured to facilitate navigation to a target location by assuming a flexible state and / or facilitate actuation by assuming a stiff state. In addition, the catheter 3001 may be configured to re-assume a flexible and / or soft state after actuating one or more anchors to continue actuating one or more anchors after evaluating one or more factors (e.g., mitral regurgitation) in response to the initial actuation of the one or more anchors.

[0282] After delivery, it may be advantageous to immediately assess the placement and / or anchoring of the anchor and / or implant. In some embodiments, the systems, devices, apparatus, methods, etc. herein advantageously allow for immediate assessment of one or more anchors and / or implants prior to removal of the delivery system. In some embodiments, these advantageously allow for adjustment of the delivered anchor and / or implant after and / or immediately following delivery and / or actuation of the anchor and / or implant.

[0283] Figure 31 Figure 31-1 and Figure 31-2 ) provides a flow chart illustrating an example method or process 3100 for actuating one or more tissue anchors and / or for evaluating one or more tissue anchors according to one or more embodiments. FIG. 32 ( Figure 30-1 and Figure 30-2 ) provides images associated with example steps of process 3100 of Figure 31.

[0284] At step 3102, the example method or process 3100 may include delivering, driving and / or anchoring one or more anchors including a first anchor 3205 at a target tissue site, as shown in image 3200a of FIG. The first anchor 3205 may be delivered via a delivery system including a catheter 3201 (e.g., an elongated shaft), an outer shaft 3204, and / or an inner shaft 3206. In some embodiments, the catheter 3201 may be a steerable catheter 3201 and / or may be configured to bend and / or otherwise navigate through an anatomical path. The catheter 3201 may include one or more pull wires configured to facilitate advancement and / or retraction of the outer shaft 3204 and / or the inner shaft 3206.

[0285] In some embodiments, the outer shaft 3204 and / or the inner shaft 3206 can be used to guide and / or place the first anchor 3205. In some embodiments, the outer shaft 3204 can be at least partially rigid. For example, the outer shaft 3204 can be at least partially resistant to bending. The outer shaft 3204 can be configured to provide sufficient rigidity and / or hardness to allow the outer shaft 3204 to extend to cause the driving and / or anchoring of the first anchor 3205. The outer shaft 3204 may include sufficient pushing ability and / or bending rigidity for driving through the implant 3203 and / or natural tissue. In some embodiments, the outer shaft 3204 may include a braided polymer and / or a laser cut hypotube.

[0286] In some embodiments, during delivery, the inner shaft 3206 can be at least partially encased within the outer shaft 3204 and / or the outer shaft 3204 can be at least partially encased within the catheter 3201. For example, the outer shaft 3204 can include an inner lumen sized to fit at least partially around the inner shaft 3206, and / or the inner shaft 3206 can be sized and / or shaped to fit within the outer shaft 3204.

[0287] In some embodiments, during guidance and / or placement of the first anchor 3205 , the outer shaft 3204 can extend beyond the distal end of the catheter 3201 to allow the stiffness of the outer shaft 3204 to facilitate driving the first anchor 3205 .

[0288] In some embodiments, the inner shaft 3206 can be at least partially flexible. In some embodiments, the inner shaft 3206 can extend with the outer shaft 3204 during actuation and / or placement of the first anchor 3205. However, the outer shaft 3204 can be configured to at least partially prevent bending and / or movement of the inner shaft 3206 during actuation and / or delivery of the first anchor 3205.

[0289] 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 be coupled to the first anchor 3205 at the distal end of the inner shaft 3206. Therefore, the extension of the inner shaft 3206 may cause the first anchor 3205 to extend toward the implant 3203 accordingly. 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.

[0290] At step 3104, process 3100 can include at least partially retracting outer shaft 3204 and / or at least partially exposing a distal portion of inner shaft 3206, as shown in image 3200b of FIG. 32. Retracting outer shaft 3204 can include pulling outer shaft 3204 further into catheter 3201 and / or away from first anchor 3205.

[0291] In some embodiments, the outer shaft 3204 can be retracted once the first anchor 3205 is at least partially driven, anchored, placed, and / or secured to the implant 3203 and / or the anatomical structure beneath the implant 3203. The retraction of the outer shaft 3204 can result in the exposure of the inner shaft 3206.

[0292] In some embodiments, the inner shaft 3206 may have a generally flexible structure and / or may be configured to bend in response to pressure against the inner shaft 3206. In some embodiments, the inner shaft 3206 may include a laser cut hypotube and / or may include one or more features configured to enhance the flexibility of the inner shaft 3206. For example, the inner shaft 3206 may have a generally thin structure and / or may be thinner relative to the outer shaft 3204. In some embodiments, the inner shaft 3206 may include one or more cavities 3208 (e.g., openings, slits, orifices, holes, grooves, etc.) configured to improve the flexibility of the inner shaft 3206. One or more cavities 3208 may extend completely and / or partially through the wall of the inner shaft 3206. For example, one or more cavities 3208 may provide an opening to the inner lumen of the inner shaft 3206. However, one or more cavities may include grooves partially cut from the wall of the inner shaft 3206.

[0293] In some embodiments, 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 generally wavy and / or oscillating form. Thus, the inner shaft 3206 can include a cavity 3208 on multiple sides and / or along a majority of the length of the inner shaft 3206 (e.g., along the entire inner shaft 3206).

[0294] In some embodiments, the inner shaft 3206 may include a lumen 3208 on one or more sides of the inner shaft 3206 and / or may not include a lumen 3208 on one or more sides of the inner shaft 3206 .

[0295] In some embodiments, the inner shaft 3206 can include a lumen 3208 only at the distal end of the inner shaft 3206 and / or not along the entire length of the inner shaft 3206 .

[0296] The inner shaft 3206 is illustrated as a tube having a solid circumferential wall, however the inner shaft 3206 may have different forms. For example, the inner shaft 3206 may include a coil and / or a wound wire and / or line. In some embodiments, the inner shaft 3206 may include an inflatable tube and / or balloon configured to be pressurized and / or depressurized with one or more gases and / or fluids.

[0297] In some embodiments, the inner shaft 3206 can be configured to maintain contact with the first anchor 3205 after the outer shaft 3204 is retracted. For example, the inner shaft 3206 can be coupled to the first anchor 3205 and / or can be configured to grasp the first anchor 3205 and / or maintain a grip on the first anchor 3205 after the outer shaft 3204 is retracted.

[0298] At step 3106, the method / process 3100 may include at least partially advancing the inner shaft 3206 further beyond the outer shaft 3204 and / or the catheter 3201 to create slack in the inner shaft 3206 and / or promote bending thereof, as shown in image 3200c of FIG. 32. As the inner shaft 3206 is advanced, the catheter 3201 and / or the outer shaft 3204 may remain in place. Thus, the distance between the first anchor 3205 and the outer shaft 3204 may remain constant. As the inner shaft 3206 is advanced, a greater amount of the inner shaft 3206 may extend and / or may fill the space between the outer shaft 3204 and the first anchor 3205.

[0299] In some embodiments, the inner shaft 3206 can be configured to naturally bend into a curved and / or wavy form to allow the distal portion of the inner shaft 3206 to fill 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, advancement and / or retraction of the outer shaft 3204 may not cause corresponding advancement and / or retraction of the inner shaft 3206.

[0300] In some embodiments, advancing the inner shaft 3206 can be configured to reduce the load from the inner shaft 3206 on the first anchor 3205 and / or create slack in the inner shaft 3206. For example, the bend and / or slack in 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 the tissue anchor 3205 and / or implant 3203 to perform a maximum amount of natural movement in response to the movement of the tissue.

[0301] In some embodiments, the inner shaft 3206 can be at least partially inflatable and / or compressible. For example, the inner shaft 3206 can be configured to be inflated with gas and / or fluid during delivery to facilitate gripping and / or actuation of the first anchor 3205. The gas and / or fluid can be aspirated out of the inner shaft 3206 and / or the inner shaft 3206 can be decompressed before or after the outer shaft 3204 is retracted to soften and / or increase the flexibility of the inner shaft 3206.

[0302] In the flexible state, the inner shaft 3206 can be configured to freely swing and / or bend (eg, complex three-dimensional and / or circular movements) in rhythm with external forces and / or in various (eg, multiple) directions.

[0303] At step 3108, the method / process 3100 may include evaluating the anchoring and / or placement of the implant 3203 and / or the first anchor 3205, wherein the inner shaft 3206 is in a relaxed and / or loose form. The relaxed inner shaft 3206 may allow movement of the anchor 3205 and / or the implant 3203. Thus, the first anchor 3205 and / or the implant 3203 may be observed when the inner shaft 3206 is in a relaxed state to determine whether the first anchor 3205 and / or the implant 3203 moves naturally and / or in a desired manner.

[0304] Any suitable imaging means may be used to assess the placement and / or anchoring of the first anchor 3205 and / or additional anchors and / or implant 3203. For example, echo and / or fluorescence imaging may be used to assess the anchors and / or implant 3203. Although process 3100 describes the placement of only the first anchor 3205, additional anchors may be delivered, assessed, and / or anchored in a similar manner.

[0305] If it is determined that anchoring of the anchor 3205 is incomplete, the inner shaft 3206 can be advantageously at least partially retracted (or pressurized) and / or the outer shaft 3204 can be advantageously advanced to allow further actuation of the anchor 3205 without reattaching the inner shaft 3206 to the anchor 3205.

[0306] If anchoring of the anchor 3205 is determined to be adequate, the catheter 3201, outer shaft 3204 and / or inner shaft 3206 may be removed from the anchor 3205 and / or may be moved to a different position to facilitate driving a second anchor into the prosthetic leaflet 3203, tissue 10 and / or other target location.

[0307] In some embodiments, after evaluating one or more factors (eg, mitral valve regurgitation) in response to initial actuation of one or more anchors, the outer shaft 3204 can be advanced to continue actuating the one or more anchors.

[0308] In some embodiments, multiple anchors can be implanted and / or evaluated simultaneously.

[0309] In some embodiments, a system for evaluating the anchoring of one or more tissue anchors includes: an outer shaft and an inner shaft, the outer shaft including an inner lumen, the inner shaft being configured to at least partially fit within the inner lumen of the outer shaft and drive one or more tissue anchors, wherein the inner shaft has a substantially flexible structure relative to the outer shaft.

[0310] In some implementations, the technology described herein relates to a system wherein the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

[0311] In some implementations, the technology described herein relates to a system in which an outer shaft is configured to be advanced and retracted independently of an inner shaft.

[0312] According to some embodiments of the present disclosure, a method for assessing anchoring 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.

[0313] In some embodiments, the method further comprises attaching the inner shaft to the tissue anchor.

[0314] In some embodiments, the method further comprises retracting the outer shaft to expose a distal portion of the inner shaft.

[0315] In some embodiments, the method further comprises advancing the inner shaft to create slack in a distal portion of the inner shaft.

[0316] In some embodiments, the method further comprises evaluating the tissue anchor with the inner shaft attached to the tissue anchor.

[0317] In some embodiments, the method further comprises advancing the outer shaft to drive the tissue anchor into the tissue.

[0318] In some embodiments, the inner shaft is substantially flexible relative to the outer shaft. In some embodiments, the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

[0319] In some embodiments, the outer shaft is configured to be advanced and retracted independently of the inner shaft.

[0320] In some embodiments, the method further comprises removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is properly anchored.

[0321] In some embodiments, advancing the inner shaft to create slack in the distal portion of the inner shaft includes allowing the distal portion of the inner shaft to flex in a plurality of directions.

[0322] In some embodiments, the method further comprises detaching the inner shaft from the tissue anchor.

[0323] In some embodiments, the method further comprises attaching the inner shaft to a second tissue anchor. In some embodiments, the method further comprises retracting the outer shaft to expose a distal portion of the inner shaft.

[0324] In some embodiments, the method further comprises advancing the inner shaft to create slack in a distal portion of the inner shaft.

[0325] In some embodiments, the method further includes evaluating the second tissue anchor with the inner shaft attached to the second tissue anchor.

[0326] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0327] According to some embodiments of the present disclosure, a method for delivering one or more tissue anchors includes delivering an elongated shaft carrying the one or more tissue anchors at a distal end of the elongated shaft to a target tissue location.

[0328] In some embodiments, the elongated shaft includes a flexure configured to move between a first state and a second state.

[0329] In some embodiments, the method can further include moving the flexure portion from the first state to the second state to facilitate driving the one or more tissue anchors into the target tissue location, and moving the flexure portion from the second state to the first state.

[0330] In some embodiments, moving the flexure from the first state to the second state may include compressing the flexure.

[0331] In some embodiments, moving the flexure from the first state to the second state includes twisting the elongated shaft until a gap is formed in the flexure.

[0332] In some embodiments, the flexure comprises at least one detachable tab between segments of the flexure.The segments may be annular.

[0333] In some embodiments, the flexure can include a network of interlocking teeth. In some embodiments, the flexure can include a coil extending through a lumen of the flexure.

[0334] In some embodiments, the coil is configured to interconnect segments of the flexure. In some embodiments, the flexure can include a cutout through the elongated shaft.

[0335] In some embodiments, moving the flexure portion from the first state to the second state includes pulling one or more pull wires extending at least partially through the flexure portion.

[0336] In some embodiments, the flexure comprises two or more segments. In some embodiments, one or more pull wires interconnect the two or more segments.

[0337] In some embodiments, moving the flexure from the second state to the first state includes releasing one or more pull wires.

[0338] In some embodiments, in response to determining that the first tissue anchor is not properly anchored, the method includes moving the flexure portion from the first state to the second state to facilitate driving the first tissue anchor further into the target tissue location.

[0339] In some embodiments, in response to determining that the first tissue anchor is properly anchored, the method includes removing the flexure from the first tissue anchor.

[0340] In some embodiments, the method further includes 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.

[0341] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0342] In some embodiments, a system for delivering one or more tissue anchors includes an elongated shaft carrying one or more tissue anchors at its distal end to a target tissue location. In some embodiments, the elongated shaft includes a flexure configured to move between a first state and a second state.

[0343] In some embodiments, the system further comprises an inner shaft configured to extend at least partially through the lumen of the elongated shaft. In some embodiments, the system may further comprise an outer shaft configured to at least partially surround the elongated shaft.

[0344] In some embodiments, the flexure can be configured to move from the first state to the second state by compressing the flexure.

[0345] In some embodiments, the flexure is configured to form a gap in response to torsion of the elongated shaft.

[0346] In some embodiments, the flexure comprises at least one detachable tab between segments of the flexure.The segments may be annular.

[0347] In some embodiments, the flexure can include a network of interlocking teeth. In some embodiments, the flexure can include a coil extending through a lumen of the flexure.

[0348] In some embodiments, the coil is configured to interconnect segments of the flexure.The flexure may include a cutout through the elongated shaft.

[0349] In some embodiments, the system may further include one or more pull wires configured to extend at least partially through the flexure portion. In some embodiments, the one or more pull wires extend at least partially through multiple sections of the flexure portion.

[0350] Any of the various systems, components, devices, equipment, 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 patients, and the methods herein may include (or the additional methods include or consist of) sterilization of the relevant systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0351] Additional description of the example

[0352] A list of examples is provided below, each of which may include aspects of any other examples disclosed herein. In addition, aspects of any of the examples above may be implemented in any of the numbered examples provided below.

[0353] Depending on the example, some actions, events or functions of any process or algorithm described herein may be performed in a different order, may be added, combined or omitted entirely. Therefore, in some examples, not all described actions or events are necessary to practice the process.

[0354] Some implementations of the present disclosure are directed to various examples, including the following.

[0355] Example 1: A system for evaluating the anchoring of one or more tissue anchors, the system comprising an outer shaft and an inner shaft, the outer shaft comprising an inner lumen, the inner shaft being configured to at least partially fit within the inner lumen of the outer shaft and drive one or more tissue anchors, wherein the inner shaft has a substantially flexible structure relative to the outer shaft.

[0356] Example 2: A system as described in any example herein, in particular Example 1, wherein the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

[0357] Example 3: A system as described in any example herein, in particular examples 1 to 2, wherein the outer shaft is configured to be advanced and retracted independently of the inner shaft.

[0358] Example 4: A method for evaluating the anchoring 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 the 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 with the inner shaft attached to the tissue anchor.

[0359] Example 5: A method as described in any example herein, particularly Example 4, further comprising advancing the outer shaft to drive the tissue anchor into tissue.

[0360] Example 6: A method as described in any example herein, in particular examples 4 to 5, wherein the inner shaft is substantially flexible relative to the outer shaft.

[0361] Example 7: A method as described in any example herein, in particular Example 6, wherein the inner shaft includes one or more lumens configured to improve the flexibility of the inner shaft.

[0362] Example 8: A method as described in any example herein, in particular examples 4 to 7, wherein the outer shaft is configured to be advanced and retracted independently of the inner shaft.

[0363] Example 9: The method as described in any example herein, particularly Examples 4 to 8, further comprising removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is properly anchored.

[0364] Example 10: A method as described in any example herein, in particular examples 4 to 9, wherein the inner shaft includes one or more lumens configured to improve the flexibility of the inner shaft.

[0365] Example 11: A method as described in any example herein, in particular examples 4 to 10, wherein the outer shaft is configured to be advanced and retracted independently of the inner shaft.

[0366] Example 12: A method as described in any example herein, particularly examples 4 to 11, wherein advancing the inner shaft to create slack in the distal portion of the inner shaft includes allowing the distal portion of the inner shaft to bend in multiple directions.

[0367] Example 13: A method as described in any of the examples herein, in particular Examples 4 to 12, further comprising: detaching the inner shaft from the tissue anchor; attaching the inner shaft to a second 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 second tissue anchor with the inner shaft attached to the second tissue anchor.

[0368] Example 14: A method for delivering one or more tissue anchors, the method comprising: delivering a slender shaft to a target tissue location, the slender shaft comprising a flexure 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.

[0369] Example 15: A method as described in any example herein, particularly Example 14, wherein the elongated shaft is configured to carry one or more tissue anchors at the distal end of the elongated shaft.

[0370] Example 16: A method as described in any example herein, in particular examples 14 to 15, wherein moving the flexure from the first state to the second state includes compressing the flexure.

[0371] Example 17: A method as described in any example herein, in particular examples 14 to 16, wherein the flexure comprises two or more segments.

[0372] Example 18: A method as described in any example herein, in particular example 17, wherein the segment is annular.

[0373] Example 19: A method as described in any example herein, particularly Example 17, wherein moving the flexure from the first state to the second state includes pulling one or more pull wires extending at least partially through the two or more segments.

[0374] Example 20: A method as described in any example herein, in particular Example 19, wherein the one or more pull wires interconnect the two or more segments.

[0375] Example 21: A method as described in any example herein, particularly Example 19, wherein moving the flexure from the second state to the first state includes releasing the one or more pull wires.

[0376] Example 22: As described in any of the examples herein, in particular the method described in Examples 14 to 21, further comprising, in response to determining that the first tissue anchor is not properly anchored, moving the flexure portion from the first state to the second state to facilitate further driving of the first tissue anchor into the target tissue location.

[0377] Example 23: A method as described in any of the examples herein, particularly Examples 14 to 22, further comprising removing the flexure portion from the first tissue anchor in response to determining that the first tissue anchor is properly anchored.

[0378] Example 24: The method as described in any of the examples herein, particularly Example 23, 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.

[0379] 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 along the threaded screw and press against the knob.

[0380] Example 26: The system as described in any example herein, in particular Example 25, further includes an inner shaft configured to extend at least partially through the knob and the threaded screw.

[0381] Example 27: A system as described in any example herein, particularly Example 26, further comprising a peg extending from the inner shaft.

[0382] Example 28: A system as described in any example herein, in particular Example 27, wherein the knob includes a channel configured to receive the peg.

[0383] Example 29: A system as described in any example herein, in particular Example 28, wherein the peg is configured to prevent rotation of the knob.

[0384] Example 30: A system as described in any example herein, particularly Examples 25 to 29, further comprising an arm coupled to the bolt, the arm being configured to press against or pull a protrusion extending from an outer surface of the knob.

[0385] Example 31: A system as described in any example herein, particularly Examples 25 to 30, further comprising a stop nut disposed along the threaded screw and located between the bolt and the handle.

[0386] Example 32: A system as described in any example herein, in particular examples 25 to 31, further comprising a washer disposed between the knob and the bolt.

[0387] Example 33: A system as described in any example herein, particularly examples 25 to 32, wherein the knob is configured not to twist in response to a force from the bolt.

[0388] Conditional language used herein, such as "may", "can", "could", "might", "for example", etc., unless explicitly stated otherwise or otherwise understood as used in the context, is generally intended to convey that certain embodiments include certain features, elements and / or components, while other embodiments do not include certain features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are required in any case for one or more embodiments, or that one or more embodiments must include logic for determining whether these features, elements and / or steps are included in any particular embodiment or to be executed therein with or without user input or prompting. The terms "include", "comprising", "having", etc. are synonyms, used in their ordinary sense, and are used inclusively in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in a non-exclusive sense (and is not used in an exclusive sense), so that when used, for example, with a list of connected elements, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is generally understood in context to convey that an item, term, element, etc. can be X, Y, or Z. Thus, such linking language is generally not intended to imply that certain embodiments require that at least one of X, at least one of Y, and at least one of Z each be present.

[0389] It should be understood that in the above description of the embodiments, various features are sometimes combined in a single embodiment, figure or its specification for the purpose of simplifying the present disclosure and helping to understand one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting the intention that any claim requires more features than the features explicitly stated in the claim. In addition, any component, feature or step shown and / or described in a specific embodiment of this document may be applied to any other embodiment or used with any other embodiment. In addition, for each embodiment, no component, feature, step or group of components, features or steps is necessary or indispensable. Therefore, the scope of the present invention disclosed herein and claimed below should not be limited to the above-mentioned specific embodiments, but should only be determined by clearly reading the attached claims.

[0390] It should be understood that certain ordinal terms (such as "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms (such as "first", "second", "third", etc.) used to modify elements (such as structures, components, operations, etc.) do not necessarily indicate the priority or order of the elements relative to any other elements, but can generally distinguish the elements from another element with a similar or identical name (but using ordinal terms). In addition, as used herein, indefinite articles ("one" and "an") can indicate "one or more" instead of "one". In addition, operations performed "based on" a condition or event can also be performed based on one or more other conditions or events that are not explicitly stated.

[0391] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments belong. It should also be understood that unless explicitly defined as such herein, terms (such as those defined in commonly used dictionaries) should be interpreted as having a meaning consistent with their context in the relevant art and the present invention, and will not be interpreted in an idealized or overly formal sense.

[0392] Spatially relative terms "external," "internal," "upper," "lower," "below," "above," "vertical," "horizontal," and similar terms may be used herein to describe the relationship between one element or component and another element or component, as shown in the figures. It should be understood that the spatially relative terms are intended to cover different orientations of the device in use or operation in addition to the orientations described in the figures. For example, in the case where the device shown in the figures is turned over, a device positioned "below" or "below" another device can be placed "above" the other device. Thus, the illustrative term "below" can include a lower position and an upper position. The device may also be oriented in another direction, and thus the spatially relative terms may be interpreted differently depending on the direction.

[0393] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less", "more", "greater", etc. are intended to encompass the concept of equality. For example, "less" may not only mean "less" in the strictest mathematical sense, but also mean "less than or equal to".

Claims

1. A system for evaluating anchoring of one or more tissue anchors, the system comprising: an outer shaft, the outer shaft comprising an inner lumen; as well as An inner shaft is configured to fit at least partially within the inner lumen of the outer shaft and to actuate one or more tissue anchors, wherein the inner shaft has a generally flexible structure relative to the outer shaft.

2. The system of claim 1, wherein the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

3. The system of any one of claims 1 to 2, wherein the outer shaft is configured to be advanced and retracted independently of the inner shaft.

4. A method for evaluating anchoring 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; as well as The tissue anchor is evaluated with the inner shaft attached to the tissue anchor.

5. The method of claim 4, further comprising advancing the outer shaft to drive the tissue anchor into tissue.

6. The method of any one of claims 4 to 5, wherein the inner shaft is substantially flexible relative to the outer shaft.

7. The method of claim 6, wherein the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

8. The method of any one of claims 4 to 7, wherein the outer shaft is configured to be advanced and retracted independently of the inner shaft.

9. The method of any one of claims 4 to 8, further comprising removing the inner shaft from the tissue anchor in response to determining that the tissue anchor is properly anchored.

10. The method of any one of claims 4 to 9, wherein the inner shaft comprises one or more lumens configured to improve flexibility of the inner shaft.

11. The method of any one of claims 4 to 10, wherein the outer shaft is configured to be advanced and retracted independently of the inner shaft.

12. The method of any one of claims 4 to 11, wherein advancing the inner shaft to create slack in the distal portion of the inner shaft comprises allowing the distal portion of the inner shaft to flex in multiple directions.

13. The method according to any one of claims 4 to 12, further comprising: detaching the inner shaft from the tissue anchor; attaching the inner shaft to a second 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; as well as The second tissue anchor is evaluated with the inner shaft attached to the second tissue anchor.

14. A method for delivering one or more tissue anchors, the method comprising: delivering an elongated shaft to a target tissue location, the elongated 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; as well as The flexure portion is moved from the second state to the first state while maintaining contact between the flexure portion and the first tissue anchor.

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

16. The method of any one of claims 14 to 15, wherein moving the flexure from the first state to the second state comprises compressing the flexure.

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

18. The method of claim 17, wherein the segments are annular.

19. The method of claim 17, wherein moving the flexure from the first state to the second state comprises 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 flexure from the second state to the first state comprises releasing the one or more pull wires.

21. The method of any one of claims 14 to 20, further comprising, in response to determining that the first tissue anchor is not properly anchored, moving the flexure portion from the first state to the second state to facilitate driving the first tissue anchor further into the target tissue location.

22. The method of any one of claims 14 to 21, further comprising removing the flexure from the first tissue anchor in response to determining that the first tissue anchor is properly anchored.

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.

24. A system for delivering one or more tissue anchors, the system comprising: handle; a threaded screw coupled to the handle; Knobs; an outer shaft coupled to the knob; as well as A bolt is configured to be twisted along the threaded screw and pressed against the knob.

25. The system of claim 24, further comprising an inner shaft configured to extend at least partially through the knob and the threaded screw.

26. The system of claim 25, further comprising a peg extending from the inner shaft.

27. The system of claim 26, wherein the knob comprises a channel configured to receive the peg and / or wherein the peg is configured to prevent rotation of the knob.

28. The system of any one of claims 24 to 27, further comprising an arm coupled to the bolt, the arm being configured to press against or pull against a protrusion extending from an outer surface of the knob.

29. The system of any one of claims 24 to 28, further comprising a stop nut disposed along the threaded screw and located between the bolt and the handle.

30. The system of any one of claims 24 to 29, wherein the knob is configured not to twist in response to force from the bolt.

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