CN112399835A

CN112399835A - Chain annuloplasty ring, delivery system, and related methods

Info

Publication number: CN112399835A
Application number: CN201980045860.8A
Authority: CN
Inventors: K·索利姆; J·O·索利姆; D·恩瓦尔; V·克鲁格; M·沃尔夫; J·贝格; A·斯潘伯格
Original assignee: Syntach AG
Current assignee: Syntach AG
Priority date: 2018-07-10
Filing date: 2019-07-10
Publication date: 2021-02-23
Also published as: MX2020013622A; KR20210030927A; JP2021531056A; WO2020011880A1; IL279340A; CA3099627A1; SG11202010733TA; BR112020025223A2; EP3820404A1; AU2019303002A1

Abstract

A partially annuloplasty ring for transcatheter heart valve repair is disclosed. The annuloplasty ring has a plurality of separate chain segments that are interconnected in series and hinged into a chain. The chain has a substantially elongated delivery configuration and a curved unfolding configuration. At least one of the chain segments has at least one tissue anchor attached thereto, wherein the tissue anchor is at least partially movably arranged within the chain segment in the delivery configuration and protrudes from the chain segment in the unfolding configuration for anchoring to cardiac tissue.

Description

Chained annuloplasty rings, delivery systems, and related methods

Technical Field

The present invention relates generally to the field of medical implantable devices for improving the function of heart valves. More particularly, examples of the invention relate to annuloplasty rings for treating heart valve insufficiency.

Background

This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

Heart valve defects such as regurgitation may be caused by the relaxation of tissue surrounding the heart valve (e.g., mitral or tricuspid valve). This causes the valve opening to enlarge, which prevents the valve from sealing properly. Such heart diseases are typically treated by the process of securing or securing an annuloplasty ring around the valve. Tying or securing tissue to the ring may restore the valve opening to approximately its original size and operating efficiency.

Typically, the annuloplasty ring is implanted during an open heart procedure, and thus the annuloplasty ring may be sutured into the valve ring. The open heart procedure is a highly invasive procedure with a high risk to the patient in many clinical aspects. Therefore, minimally invasive concepts for delivering annuloplasty implants are under development. Most commonly, however, ring remodeling is performed, for example, by introducing a remodeling device in the coronary sinus surrounding the mitral annulus. The shape is then fixed by an annuloplasty ring attached to the annulus tissue. Although several concepts were pursued, all have shortcomings.

In US patent application publication No. US2018/0008409a1, a device is disclosed, the device comprising a ring comprising a plurality of struts arranged in an alternating pattern of peaks and valleys, each strut having a first end and a second end, each peak being defined by the convergence of adjacent first ends arranged at an angle relative to each other, and each valley being defined by the convergence of adjacent second ends. The apparatus also includes a plurality of anchors. Each anchor has a longitudinal axis, is configured to be driven into tissue of the heart along the longitudinal axis, and is coupled to the ring at the respective trough in a manner that facilitates (i) movement of the anchor relative to the trough along the longitudinal axis and (ii) deflection of the longitudinal axis relative to the trough.

In U.S. patent application publication No. US2013/0226289a1, devices, systems, and methods are disclosed for repairing a heart valve by percutaneous transcatheter delivery of an annuloplasty ring and fixation to the heart valve. An annuloplasty ring is disclosed that includes an outer hollow body member including a plurality of regions. The adjacent regions cooperate to change the body member from an elongated insertion geometry to a looped operable geometry. Adjacent regions are coupled by a biasing element or stepped connector to allow expansion to an expanded state and contraction to a contracted state in an annular operational geometry. The annuloplasty ring also includes an inner anchor member at least partially within the body member and having a plurality of anchors configured to attach the annuloplasty ring to tissue of the heart valve annulus. An angled ring closure lock allows coupling of an end of an annuloplasty ring at the tip of a D-shaped annular operable geometry.

In U.S. patent application publication No. US2012/0245604a1, devices, kits, and methods are disclosed that may include or employ an implantable device (e.g., an annuloplasty implant) and a plurality of tissue anchors. The implantable device is positionable in a lumen of a body organ (e.g., a heart) and is operable to constrict a body orifice (e.g., a mitral valve). The individual tissue anchors may be guided to precise locations by intravascular or percutaneous techniques. The constriction of the orifice can be achieved via various structures, such as an articulated annuloplasty ring, which is attached to a tissue anchor. Annuloplasty rings may be delivered in an un-anchored, generally elongated configuration and implanted in an anchored, generally arched, arcuate, or annular configuration. This allows access to the septum and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to reduce mitral regurgitation.

Thus, there is a need for a new and improved transcatheter delivered annuloplasty ring that allows for flexibility in the procedure.

Disclosure of Invention

Accordingly, embodiments of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device, a system, and a method according to the appended independent patent claims. Further embodiments of the invention are defined in the dependent claims, wherein the features of the second and subsequent aspects of the invention are the same as the features of the first aspect, mutatis mutandis. The present disclosure may include additional inventions not presently claimed.

In one aspect of the present disclosure, an implantable medical device for heart valve treatment is provided that includes an annuloplasty ring at least in part. Annuloplasty rings have a plurality of separate segments that are interconnected in series and articulated, thereby forming a chain. The strand has a substantially elongated delivery configuration and a curved deployment (deployment) configuration. The smallest one of the segments of the chain has at least one tissue anchor movably attached thereto. The tissue anchor is at least partially disposed within the chain segment in a movable state in the delivery configuration. The tissue anchoring elements of at least one segment are preferably arranged to protrude from the segment in the deployed configuration, oriented towards adjacent cardiac tissue, so as to be anchored with the cardiac tissue.

Thus, an at least partially annuloplasty ring for transcatheter heart valve treatment is provided. A partial ring is defined as an open, non-closed ring, whereby it is only a part of the ring. The term transcatheter means that the annuloplasty ring and associated devices, if any, are delivered by a catheter from outside the patient's body to the cardiac tissue site inside the patient via a catheter (i.e., a tubular elongated device) to receive the annuloplasty ring and associated devices, sequentially if needed, in the inner lumen of the catheter during delivery. The distal end of the catheter is brought to the site while the proximal end is held outside the patient. The device is then advanced into the lumen until the distal end of the catheter reaches the cardiac tissue site and is deployed out of the catheter. Transcatheter delivery includes, for example, intercostal access, transvascular access, transapical access, and the like. Specific examples are provided in the detailed description herein.

In one aspect of the present disclosure, a deployment apparatus for a chain annuloplasty implant is provided. The device comprises a double lumen catheter and a wire with a screwdriver unit.

In one aspect of the present disclosure, a method of deploying a chain annuloplasty implant is provided. The method comprises the following steps: a chain implant 100 is provided. The method comprises the following steps: the chain implant is delivered to the annulus of the heart valve, anchoring the chain implant 100 to the annulus by screwing the screw tissue anchors 120 into the annulus. In the case where the chained implant is not a pure anchor implant but is an annuloplasty implant, the method comprises: the chain implant 100 is optionally shortened for annuloplasty. The method further optionally comprises: the chain implant is stabilized by locking one or more arms 141,142, 143.

In one aspect of the disclosure, a method of treating a heart valve is provided. The method comprises the following steps: performing annuloplasty by shortening the anchored loop implant and preferably by patient-specifically adapting the curvature of the loop implant; stabilizing the link implant with one or more arms 141,142, 143; and optionally connecting the arms to a heart valve tissue anchor, a heart assist device, or a valve repair or replacement unit.

Drawings

Fig. 1 is a schematic view of a heart and its anatomical structures, the structures involved being depicted in a partial cross-sectional schematic view of a human heart.

Fig. 2 is a schematic view of a heart and its associated heart valves and heart axis.

Figure 3 is a top view of an annuloplasty ring chain with tissue anchoring elements.

Fig. 4 is a 3D view of the loop of fig. 3 with the tissue anchor protruding.

Fig. 5 is a 3D view of the ring of fig. 3 with the stabilizing arms attached thereto.

Fig. 6 is a detailed view of the loop of fig. 5, illustrating deployment of the tissue anchor and deployment of the tissue anchor within the chain segment in a deployed state from the delivery catheter.

Fig. 7a, 7b, 7c, 7D are top 3D elevation views of a portion of an elongate annuloplasty chain, with adjacent chain elements extending unconstrained by a catheter, and transitioning to a ring shape for illustration purposes and with protruding tissue anchors.

Fig. 8a, 8b are detailed 3D front views of the chain link.

Fig. 9 and 10 are different top 3D elevation views of a portion of an elongate annuloplasty chain having a chain element and two tissue anchors protruding from the element.

Fig. 11 is a 3D top view of a chain element corresponding to fig. 9-10.

Fig. 12 is a bottom 3D side view of a chain element corresponding to fig. 9-11.

Fig. 13 is a bottom 3D side view of two chain elements during shortening.

Fig. 14 is an elevational 3D top view of the two chain elements after shortening.

Fig. 15 is an elevational, 3D top view of a chain link with anchors after shortening the annuloplasty and with three stabilizing arms locked in the center of the chain link.

Fig. 16 is a 3D front view of the chain link of fig. 15.

Fig. 17 is an elevational, 3D top view of the chain link illustrating the locking unit including the locked arm.

Fig. 18, 19, and 20 are top and 3D elevation views of the link in an elongated delivery configuration.

Figure 21 is a schematic view of an annuloplasty ring in an interior view of a lumen.

Fig. 22 illustrates a delivery view of a chain annuloplasty ring with end segments of the chain protruding from the delivery catheter.

Fig. 23a to 23c are schematic views of a percutaneous transcatheter approach to the heart.

Fig. 24 a-24 b are schematic diagrams showing a direct access path to a heart valve via an incision in the skin and a puncture 95 in the apex of the heart.

Fig. 25-26 are schematic diagrams depicting an example of a complete annuloplasty ring implantation of a medical device.

Fig. 27 is a schematic view of a multi-lumen catheter 150 disposed in a delivery catheter 155 and an introduction catheter 123.

Fig. 28 and 29 are cross-sectional views of two lumens in the multi-lumen catheter 150 from fig. 27.

Fig. 30-42 are schematic step views of a method for deploying a chain annuloplasty implant.

Fig. 43 a-43 b, 44 a-44 b, 45 a-45 b, and 46 are schematic illustrations of separate segments and their components during various stages of assembly.

Figures 47 a-47 c are schematic views of different chain annuloplasty ring configurations.

Figures 48 a-48 d are schematic views of a pre-installed annuloplasty ring.

Fig. 49a to 49e are schematic views of a single arm system and a pre-mounted holder.

Fig. 50a to 50c are schematic views of a detachable pre-mounted turning tool.

Detailed Description

Specific embodiments of the present invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbering represents like elements.

Fig. 1 depicts the anatomy of a heart 1, at least some of which are involved in an embodiment of the invention, 2 is the Superior Vena Cava (SVC), 4 is the Right Atrium (RA), 6 is the ostium of the Coronary Sinus (CS), 8 is the first portion of the CS, 10 is the Inferior Vena Cava (IVC), 12 is the Great Cardiac Vein (GCV) at the level of the Mitral Valve (MV)

annulus

18, 14 is the left atrial chamber (LA), 16 is the LA wall, 19 is the entire mitral valve, 20 is the anterior leaflet, 21 is the posterior leaflet of the mitral valve, 22 is the Left Ventricular (LV) muscular wall, 24 is the papillary muscle connected to the chordae tendineae, 26 is the left ventricle, 28 is the aortic valve, 30 is the ascending aorta, 32 is the interventricular muscular diaphragm, 34 is the left ventricular chamber, 36 is the right ventricular chamber, 38 is the ventricular muscular wall, and 40 is the tricuspid valve.

Fig. 2 shows a heart valve plane 48 in relation to the heart axis 49 of the left ventricle.

In an example, an implantable medical device for heart valve treatment is provided that includes an annuloplasty ring 100, at least in part. Annuloplasty ring 100 has a plurality of separate segments 110 interconnected in series and hinged to chain 100. The chain 100 has a first, substantially elongated delivery configuration and a second, curved, deployed configuration. At least one segment 110 includes at least one movably attached tissue anchor 120. Fig. 3 is a top view of a chain of annuloplasty rings 100 with tissue anchoring elements 120. Fig. 4 is a 3D view of the loop 100 of fig. 3 with the tissue anchor 120 protruding.

Description of the chain segment 110 elements of the chain link 100:

the segment 110 may include one or more of the following items or features of the segment body. The body preferably has a curved shape 360 and includes a first end 320 joined to the second end 340 of a first adjacent segment.

The first end 320 is matingly received therein. In the illustrated example (see in particular the assembly described below with respect to fig. 43-46), the first end 320 is a protrusion configured to engage with a corresponding groove or slot 342 of the end 340. Similar mating connection interfaces may be provided in other examples. When inserted into the slot 342, the stop surface 343 prevents further movement of the adjacent first end 320. A second tissue anchor hole 346 is provided for receiving tissue anchor 120. When inserted into and blocking slot 342, the tissue anchor acts as a stop to prevent inadvertent tooth 328/358 engagement and irreversible shortening until anchoring into the tissue and releasing slot 342.

The rounded end 344 is provided for tissue friendly properties upon implantation and for ease of tissue overgrowth.

The second end 340 is arranged to engage another adjacent chain segment in the opposite direction of the chain. In the illustrated example, the second end 340 has teeth 358 that matingly receive the teeth 328 of the adjacent segment first portion. Gap 331 allows the arm with teeth 328 to flex over teeth 358. The toe 330 limits the flexible movement and prevents the arm from slipping out too far. The first end 320 has an internal groove with teeth 328 disposed therein along a first axis 322, and the distal end extends beyond the teeth and outwardly along a second axis 324 at an angle to the first axis 322 to allow for a substantially elongated delivery configuration (see below). When assembled, the inner grooves receive therein the attachment units 350 of adjacent segments. The attachment unit is arranged to move relative to the inner groove and along axis 322 and to pivot about knee 326 along axis 324.

The attachment unit 350 has mating engagement teeth 358 arranged externally thereof to provide irreversible engagement and relative movement of two adjacent segments 110. The attachment unit 350 has an inner bore 352. Within the internal bore 352, an element, such as a tissue anchor 120 or a (pivotable) attachment of an arm, may be received. Thus, the attachment unit 350 has several advantageous functions, including pivotably holding the two segments together, providing irreversible shortening (teeth), and attaching additional elements. The attachment unit 350 is elliptical and is received in the elliptical hole 354 to prevent rotation of the attachment unit 350 in the hole.

A spring attachment hole 348 is provided for the spring 135 and receives the wire 130 therethrough. The wires 130 are arranged into adjacent chain elements. The wire end 136 of the attachment element, which may include a threaded element such as shown in fig. 45 a-45 b, is positioned to engage the hole 325 of the adjacent chain segment such that pulling the wire/pull cord 130 will move (shorten) the two chain segments toward each other. The wire 130 (and the spring 135) is in the example arranged to be detachable for removal after shortening and locking of the link segments. This may be advantageously implemented by loosening the threaded wire end 136 or other removable unit. The wire 130 (and spring 135) may then be removed from the body.

Other examples of chain segments include only a first end 320, typically the end piece of the chain.

Some examples of chain segments have two first ends or two second ends connected via a center piece (like an intermediate piece for a symmetrically constructed chain link). In some examples, the links are symmetrically constructed, including "mirror image" chain elements around such centerpiece segments.

The tissue anchor 120 is at least partially disposed within the segment 110 in a movable state in a delivery configuration, see, e.g., fig. 18-22. As such, the delivery catheter 155 having the smallest inner diameter may be used for delivery because no tissue anchor 120 protrudes radially from the annuloplasty implant during delivery until deployment.

The tissue anchor 120 is suitably moved to protrude from the segment 110 in the deployed configuration for anchoring with adjacent cardiac tissue into which the annuloplasty implant is desired to be anchored. When tissue anchor 120 is extruded in the deployed configuration, it remains attached to the annuloplasty implant, such that the annuloplasty implant is securely anchored to the tissue. The transition from the recessed position to the protruding position in the annuloplasty implant may be provided by suitable means, such as a screw-advance, a spring-loaded release, an expandable member pushing the anchor outwards, etc. Examples of thread advancement are described further below.

In an example, when deployed, annuloplasty ring 100 may have an open curved annuloplasty shape. An example is the configuration of a C-shaped annuloplasty ring when deployed. In this case, two opposite end sections 110 of the elongate chain constitute the ends of the open-curved annuloplasty ring 100. Examples are shown in fig. 3, 4, 5, 15, 16, 17, 25, 26, and 38 to 42.

Specific link end segments 110 can be provided, see, for example, fig. 5 and 6, 15, 16, 17, 22, 36, and 38-42. When the ring is embedded in the heart valve tissue at the time of implantation, the end segments may be rounded to be tissue friendly and to allow good endothelialization.

Alternatively, the annuloplasty ring 100 may have a closed loop shape (not shown), such as circular, oval, D-shaped, and the like. When the chain is unfolded, the two opposite end segments 110 of the elongated chain are brought together and connected to each other in place so as to close the loop. The two end segments 110 may be attached to each other by means of a suitable fastening unit. Alternatively or additionally, the two end segments may be magnetic with opposite polarities at the mating ends for magnetic closure of the chain in the body at the heart valve. The link elements may be attached between the two end segments to close the chain loop. Alternatively or additionally, the closure may be provided by inserting an element connecting the first and last chain elements of the chain together after deployment.

The annuloplasty ring 100 is a flexible ring at least in the delivery configuration and when deployed. After deployment, the loop may be reinforced or locked into an inflexible configuration, for example by stabilizing arms, such as arms 141,142,143 shown in the figures.

One or more arms 141,142,143 may serve several advantageous purposes. First, they serve as a retainer 170 for positioning from the catheter into the correct cardiac tissue location during delivery of the implant. The implant can be easily grasped by means of the arms, see for example the delivery examples illustrated in fig. 30 to 42. Second, when locked in place and the delivery system is withdrawn, they serve as a stabilizing unit for the chain link 100. However, after anchoring the links, for example for links that do have annuloplasty options, one or more arms may be removed. This may for example be an anchor chain ring with shortening features. The arm may be removed with the delivery system (and thus be part of the system).

An anchor loop having arms may be provided that does not have a shortening feature and serves as an anchor for a heart assist device for controllably assisting in the movement of the heart valve plane.

In the example, the arm 142 includes an eyelet 145 near its distal end for receiving a securing tether 160. This allows for a simple and safe delivery of the chain implant with a reduced radiation dose required during delivery. The apertures 145 may advantageously be arranged in a surface angled with respect to the longitudinal extension of the arms 142. This latter arrangement of the eyelets 145 reduces the risk of breakage when the tether 160 is tethered.

The arms may have second (distal) ends that matingly engage each other. For example, three arms are shown in the figure. The second end of one or more arms may comprise a level compensation member such that the locking unit is insertable, e.g. positioned in the common through hole, for locking the arms in the centre of the chain ring, see e.g. fig. 5.

Annuloplasty ring 100 is configured to be permanently anchored at an annulus of a patient's heart valve. Preferably, one or more tissue anchors 120 are provided for this purpose. The tissue anchor 120 provides a reliable anchoring in heart tissue, such as preferably in annulus tissue of a heart valve, while being attached directly or indirectly to an annuloplasty implant. In this way, the annuloplasty implant may be secured to the heart tissue by means of the tissue anchor 120.

In an example, the tissue anchor 120 is preferably connected to the segment 110. The tissue anchor 120 has a distal tissue anchoring portion. In an example, the distal tissue anchoring portion includes a helical or threaded tissue anchor 120 portion for screwing the distal anchoring portion into tissue for anchoring therein.

The proximal end of the tissue anchor 120 is configured to remain attached to the annuloplasty implant, and in more detail, to the segment 110 of the annuloplasty implant. The proximal attachment may include a threaded segment that is matingly secured in the chain segment 110. As the threads are rotated, e.g., engaged via a screw head of a suitable rotary screw tool 200, the tissue anchor 120 is advanced distally toward and into adjacent cardiac tissue (if present).

The direction of movement of the tissue anchor 120 is radially outward from the deployed chain 100 toward the tissue. This direction may extend substantially perpendicular to the longitudinal direction of the chain 100 (bending when unfolded). If desired, and as appropriate for optimal tissue anchoring, the direction of removal from the chain elements 110 may be slightly inclined relative to the longitudinal direction. Different tissue anchors 120 along the chain 100 may be provided at different oblique angles to improve anchoring of the annuloplasty implant to the heart tissue.

The tissue anchor 120 is compressible to a compressed configuration in an example. For example, the tissue anchor 120 has a bayonet lock arrangement at its tip as a head. The tissue anchor 120 has a helical spring portion extending from the head. By virtue of the head being configured to interlock with a corresponding bayonet lock seat 119 in the link body, the helical spring portion may be locked in a compressed state in the link body between the bayonet lock seat 119 and the opposite secondary seat 118 for receiving a lower end/tip portion of the helical spring portion. The tissue anchor is contained in the chain element body in a compressed state until delivered/released, for example, by unscrewing the body with a screwing tool 200. In this way, the tissue anchor, when released/extruded from the segmented body into adjacent cardiac tissue, can extend to a length that is longer than the compressed length. See, for example, fig. 43b and 44b, for reference to the seats 118, 119 (compression screws not shown).

In an example, annuloplasty ring 100 has the shape of a ring. The ring shape may be open or closed. Annuloplasty ring 100 has an unlocked state for delivery through delivery catheter 155 and deployment at a heart valve target site. The ring 100 is flexible so that it can change from a substantially elongated delivery shape to a curved or bent annular shape at the heart valve tissue. Flexibility is provided, at least in part, by segments 110 that are interconnected (i.e., linked) together and can articulate relative to one another like a chain. Additionally or alternatively, flexibility may also be provided by non-preferred flexible elements or segments (e.g., flexible chain segments) integrated into the chain. The unlocked state is obtained by articulating the segments 110 to each other by joint segments. The annuloplasty ring 100 is preferably rigid in a direction perpendicular to the longitudinal direction in which the chain 100 is bent. This does not necessarily mean that the ring 100 is flat, having a curvature substantially in a single plane (which is preferred), in an example it may have a three-dimensional shape, such as a saddle or other local anatomical shape adapted to the 3D anatomical curvature of the heart tissue (e.g. the annulus of a heart valve). Lateral or vertical rigidity is achieved, for example, by the fact that one or more joints can each be rotated only in one plane about the joint axis.

The chain length of the annuloplasty ring 100 may, for example, be adjusted by movably arranging at least two adjacent segments 110 with respect to each other. Adjacent segments 110 are preferably arranged to shorten relative to each other upon deployment and more preferably after being anchored to the cardiac tissue by at least tissue anchors 120 attached to the chain 100 being caused to protrude and become anchored to the cardiac tissue. Thus, the shortening of the chain 100 provides annuloplasty, i.e. remodeling of the annulus tissue to treat regurgitation of the heart valve.

Foreshortening may be provided by a drawstring, wire 130, or other tether for drawing at least two adjacent chain segments 110 toward each other. Pulling on the wire 130 will move the two chain segments 110 towards each other, which reduces the total length of the two adjacent chain segments 110, respectively. The reduced length can then be locked by suitable locking units 370, which are preferably configured as irreversible locking lengths.

At least one segment 110 is curved in the longitudinal direction. The curved segments are arranged to shorten relative to adjacent joined chain segments 110 such that the curvature at the joined segments 110 is adjustable as the length of the two joined chain segments 110 shortens. Thus, as two adjacent chain segments 110 move relative to each other, the curvature of the chain 100 changes. For example, by shortening the total length of two adjacent segments 110, for example by sliding one segment 110 over or into the other segment 110, not only is the length made smaller, but the radius of the curve described by the two segments 110 is made smaller. This change in curvature as the overall segment length changes relative to the curvature of the segment 110 is illustrated in more detail herein and with reference to the drawings.

Annuloplasty ring 100 comprises more than two preferably curved segments 110 arranged to be individually shortened relative to adjacent segments 110. Some adjacent segments 110 may not be able to shorten relative to each other, depending on the desired curvature obtained after the segments 110 may shorten. In this way, the curvature of the ring 100 may be adjusted differently at different interconnect segments 110. The desired overall curvature of the link 100 may be determined by its segments 110. The variable adjustability of the segments 110 relative to each other at the time of delivery allows room for actual performance in annuloplasty. This is particularly advantageous because a single chainring 100 can be used for many different patients and treatments. The adjustment by shortening individual or all segments 110 is preferably based on feedback based on imaging, such as Doppler (Doppler) ultrasound reflux determination, contrast agent based X-ray blood flow determination, MR imaging, and the like.

The chain elements 110 may be provided with fixed curvatures that differ from each other. Alternatively or additionally, in some examples, the overall length of the segments 110 may be different. Alternatively or additionally, different pairs of segments 110 of the chain link 100 may have different adjustable overall lengths, thereby having different curvatures of two adjacent segments 110. In this way, flexibility regarding anatomical prerequisites and treatment needs of different patients may be taken into account when selecting a particular link 100 prior to implantation. Thus, even for specific adjustments by the surgeon after deployment of the links 100 at the cardiac tissue site, the curvature, and thus the shape, of the links is flexible and adaptable. As an example, the same link 100 may change from a delivery configuration to a C-shape or horseshoe shape, which is a more elongated C-shape.

Preferably, the link 100 has a final fixed shape upon delivery and anchoring, and an annuloplasty shape change that is at least partially circular, partially elliptical, horseshoe-like, C-shaped, or the like.

The final shape may be predetermined based on the particular patient treatment needs. Input data from the imaging modality may be provided for simulating, for example, a desired shape of a heart valve annulus, a desired coaptation of valve leaflets, etc., in order to improve valve function after treatment, such as reducing regurgitation. Thus, the configuration of the link 100 annuloplasty may be created based on the desired treatment outcome.

The length, size, curvature, number, etc. of the segments may be determined by the desired resulting final shape. Additional inputs would be available delivery modes and pathways, including available minimum and maximum diameters and curvatures of the access pathway, inner and outer diameters of the delivery catheter, bendability of the catheter, and the like.

The final shape of the chain link 100 after deployment may be based on the average population and the desired therapeutic result.

Adjacent segments 110 in annuloplasty ring 100 include cooperatively arranged locking elements 370 for irreversibly shortening the overall length of the two adjacent segments, such as snap-in locking elements.

In some examples, the tissue anchor 120 is arranged as a stop element that, when at least partially arranged within the chain segment 110, prevents shortening of two adjacent chain segments 110 prior to being arranged to protrude from the chain segment 110.

In a particular example, the tissue anchor 120 is arranged as a removable stop element in a delivery configuration. The stop element 120 prevents two adjacent chain segments 110 from shortening. When the stop is removed, the two chain elements 110 can be shortened, which can be done irreversibly.

In this way, tissue anchor 120 acts as a removable stop element to prevent annuloplasty from potentially being performed unintentionally while being delivered. Such a stop element is particularly advantageous when the shortening is irreversible and should not occur unintentionally or accidentally.

In an example, the tissue anchor 120 is a stop screw 120 that prevents irreversible shortening, for example, before the annuloplasty ring 100 implant is anchored in the heart valve tissue. Thus, the tissue anchor 120 prevents the annuloplasty from being performed unintentionally at the time of delivery, and improves delivery safety and safety of the procedure as well as patient safety.

In particular, the proximal end of the tissue anchor 120 may be provided as a screw, i.e., having a proximal portion that is threaded and matingly engages a threaded hole in the segment 110. The distal end of the tissue anchor 120 screw is shaped for secure anchoring in tissue, such as a corkscrew shaped for secure anchoring in heart tissue like valve annulus tissue.

The curved, expanded configuration of annuloplasty link 100 is provided, for example, by inwardly actuating spring elements 135 between adjacent segments 110. In the substantially straightened, elongated delivery configuration of the chain link 100, the spring elements 135 of adjacent segments 110 are stretched from their relaxed configuration by straightening the chain. Such that the link 100 is configured to flex back to the curved deployed configuration from the delivery configuration. The initial shape of the chain link 100 after deployment is a curved shape with the spring elements 135 substantially relaxed. In the case where some chain elements are prevented from returning completely back to return to the spring relaxed configuration, for example by anatomical or artificial structures in the body, this may provide a beneficial clamping effect that initially secures the chain links 100 in place before anchoring the tissue anchor 120 in the heart tissue and before the shape of the chain links 100 is changed for annuloplasty. Thus, link 100 has an initial first curvature shape when deployed from constraining delivery catheter 155.

In an example, the spring element 135 may be provided as a tab (not shown in the figures). The spring element 135 may also be an ejection spring, a pre-bent elongated unit, e.g. attached with a spring element holder 134 along the chain segments 110, such as a pre-bent wire (see e.g. fig. 5, 36, 38-42), such as a pre-bent wire made of superelastic nitinol.

Another example of a spring element 135 is illustrated in "fig. 48a to 48 d". A plurality of arms (four arms in the example, but other numbers of arms may be used, such as at least 2 arms, such as 2, 3, 5, 6, 7, 8 arms) are provided. In the example, four

arms

241, 242, 243, 244 are provided, for example in the form of pre-bent wires, such as made of superelastic nitinol, for use as the spring element 135. The

arms

241, 242, 243, 244 straighten when pulled into the delivery catheter lumen. As the

arms

241, 242, 243, 244 bend, they are spring loaded in the catheter lumen. Upon release from the catheter lumen, the

arms

241, 242, 243, 244 flex back to the curved configuration. Such that the link 100 is configured to flex back to the curved deployed configuration from the delivery configuration. The

arms

241, 242, 243, 244 function as inwardly actuated spring elements 135 between adjacent chain segments 110 similar to that described above. The initial shape of the chain link 100 after deployment is a curved shape with the spring elements 135 substantially relaxed.

The

arms

241, 242, 243, 244 may also be used to adjust the angular orientation of the deployed chain loop 100 relative to the longitudinal axis of its delivery lumen, such as included in the multi-lumen catheter 150, and/or disposed in the delivery catheter 155 and/or the introduction catheter 123.

Adjustment of the angular orientation may be achieved by moving the

arms

241, 242, 243, 244 relative to each other (e.g., by pushing and pulling the arms). The

arms

241, 242, 243, 244 may be individually movable. Thus, the

arms

241, 242, 243, 244 may have different extensions from the delivery lumen, thereby resulting in adjustment of the angular orientation as described herein.

Alternatively or additionally, a change in shape or curvature of the link 100 may be provided by the

arms

241, 242, 243, 244 for annuloplasty. The change in shape or curvature of the chain link 100 may be achieved by moving the

arms

241, 242, 243, 244 relative to each other (e.g., by pushing and pulling the arms).

The

arms

241, 242, 243, 244 may provide similar functionality as the pull cord 130. Thus, the shortening of two adjacent segments 110 may be provided by: the

arms

241, 242, 243, 244 are moved relative to each other in order to move the two adjacent segments 110 relative towards each other to reduce the total length of the two adjacent segments 110, respectively.

The

arms

241, 242, 243, 244 are illustrated as curving back from the opening of the delivery device. The bends may have different curvatures for different arms.

Thus, during deployment, the angular orientation is adjustable relative to other structures (e.g., relative to cardiac tissue at the target). As such, the link 100 may be delivered to its target site to improve anchoring, as the tissue anchor 120 may be brought to a desired location with preferred anchoring capabilities. The link 100 may be substantially apposed to the annulus tissue prior to anchoring. This provides the most reliable annuloplasty when, for example, shortening the anchoring ring for annuloplasty.

Additionally or alternatively, the angular orientation of the chain ring 100 may be adjustable relative to the structure of the medical implantable device or system comprising the device. The structure may comprise an extension unit and/or a locking unit 140 for fixing tissue of the heart valve and/or at least a part of the shape of the fixation link 100 and/or for connecting to a further unit, preferably a heart valve replacement or repair unit and/or a drive unit such as a heart assist device.

For example, adjustment of the angular orientation of the links 100 relative to the extension unit and/or the locking unit 140 may be provided, and may be advantageous for fixing the implanted links relative to the tissue of the heart valve via the connected extension unit and/or locking unit 140. Various extension units and/or locking units 140 are described below. Thus, for example, the links may be inclined, for example, with respect to the longitudinal axis of the heart, while the extension elements extend substantially along such a longitudinal axis.

For example, adjusting the angular orientation of the link 100 may be provided to fix at least a portion of the shape of the link 100.

For example, an angular orientation of the adjustment link 100 may be provided for connection to and spatial orientation relative to another unit, preferably a heart valve replacement or repair unit.

For example, the angular orientation of the adjustment link 100 may be provided relative to a drive unit, such as a heart assist device.

In any case, adjusting the angular orientation of link 100 provides adjustability of the plane of the loop relative to the longitudinal axis of another structure of the medical implantable device, such as an extension unit, a fixation unit for fixation of heart valve tissue, a heart valve replacement or repair unit, and/or a heart assist device. Thereby, the ring positioned at the target site is more flexible and provides improved assembly and long-term functionality of the medical implantable device. Also, in this way, delivery towards difficult to reach anatomical structures is facilitated.

The

arms

241, 242, 243, 244 may be detachable, for example in a similar manner as described below in connection with fig. 50 b-50 c and/or 49 d. The

arms

241, 242, 243, 244 may remain attached after deployment and then later be used as, for example, an extension unit or another unit, preferably a heart valve replacement or repair unit and/or a drive unit, such as a heart assist device, or arranged to secure at least one leaflet and/or chordae tendinae to the extension unit to limit its range of motion during the cardiac cycle.

Thus, a method of performing annuloplasty may be provided by: by shortening the anchored loop implant and preferably patient-specifically adapting the curvature of the loop implant; stabilizing the link implant with one or

more arms

241, 242, 243, 244; and optionally connecting the arms to a heart valve tissue anchor, a heart assist device, or a valve repair or replacement unit.

The

arms

241, 242, 243, 244 may provide similar functionality as the lockable arms 141,142,143 described herein. Both types of arms may be provided alternatively or in combination.

Alternatively or additionally, a spring element 135 of a shape memory material activated by body temperature may be provided. In this way, delivery through the catheter may be easier without requiring the link 100 to be advanced into the catheter and strive to return to the curved configuration. Due to the shape memory material used, a separate sheath around link 100 may be eliminated and/or a simpler delivery catheter 155 without an internal sliding modified liner may be used for delivery.

In an example, the ring 100 is adjustable to a second curved shape (e.g., of smaller radius) for annuloplasty when deployed from an initial first curved deployment configuration in preparation for annuloplasty. After being shaped to the initial first curved deployed configuration and apposed to the heart tissue, the tissue anchors 120 are released or actively engaged into the tissue to anchor the links 100 to the heart tissue, preferably at an annulus such as the mitral valve annulus. Annuloplasty is then performed by changing the shape of the chain loop 100 to a second curved shape, thereby moving and reshaping the heart tissue. In particular, if tissue anchor 120 is a stop screw as described above, and the stop screw is moved to protrude from link segment 110 into the tissue, annuloplasty may only be performed in the correct order, i.e., after anchoring tissue anchor 120.

In an example, the link 100 comprises at least one lockable arm 141,142,143 for stabilizing the annuloplasty link to the heart tissue at the annulus of the heart valve.

The lockable arms 141,142,143 are described in a concurrently filed PCT patent application by the same applicant entitled "implantable heart valve improved device, system and method", and claiming priority from european patent application No. EP18182804.7 filed under the same title on 7/10/2018 and U.S. patent application No. 16/0317327 filed under the same title on 7/10/2018. These patent applications are incorporated herein by reference in their entirety for all purposes. In particular, the disclosure of the lockable arms 141,142,143 for various purposes is incorporated into the examples of the chained annuloplasty ring 100 presently described herein, in particular for stabilization purposes or for connecting additional elements. Fig. 5 is a 3D view of a ring similar to that of fig. 3 with stabilizing arms attached thereto.

For example, the annuloplasty ring 100 alternatively or additionally comprises at least one such lockable arm 141 having a first end pivotally attached at a first circumferential location of the chain link 100 at the chain element 110 of the chain link. The lockable arms 141 are preferably pivotable in a plane drawn upwards by the link 100 and in an inner-centre direction of the link 100.

Thus, the lockable arms 141 may extend in the longitudinal direction of the link 100 during delivery in the delivery configuration and pivot from the link 100 towards the center of the link when deployed.

The lockable arm 141 has an opposite second end portion including the locking unit 140. When the arms 141 are locked by the locking unit 140 relative to the second circumferential position of the chain link 100, at least a part of the shape of the chain link 100 is fixed.

In an example, the ring 100 includes a plurality of lockable arms 141 that are respectively locked to each other at the second end. Preferably, the second ends of the arms 141 meet in a central region of the link 100. An example of three lockable arms 141,142,143 having a star configuration (e.g., about 120 degrees between each arm) is illustrated.

The arms 141,142,143 are locked when the annuloplasty is completed, i.e. when: after performing annuloplasty, link 100 has a second curved shape by changing the shape of link 100 to the second curved shape as described above.

Alternatively or additionally, the chainring 100 is connected to the leaflet tissue via such arms 141. The second end of arm 141 may be locked to the leaflet tissue. Locking may be performed by various fastening units 140 like heart valve tissue locking units, such as tissue screw anchors at the second end, clamps, sutures, staples, attachment units attachable to patches at the leaflets, etc., which are earlier surgically attached to the leaflets. Thus, the movement of the leaflet tissue is restricted.

Suitable arms 141 are described in a concurrently filed PCT patent application by the same applicant entitled "implantable heart valve improved device, system and method", and claiming priority from european patent application No. EP18182804.7 filed on 7/10/2018 under the same title and us patent application No. 16/0317327 filed on 7/10/2018 under the same title. These patent applications are incorporated herein by reference in their entirety for all purposes. In particular, when connected to the example of the chained annuloplasty ring 100 presently described herein, the disclosure of the arms 141,142,143 for connecting the annuloplasty ring in combination with the "leaflet clip" is incorporated herein, in particular for the synergistic treatment of valvular regurgitation, preferably in addition to the stabilization purpose.

Alternatively or additionally, the ring 100 is connected to a heart assist device to support movement of the heart valve.

Cardiac assist devices are disclosed in, for example, international patent applications by the same inventor as the present application, having publication numbers WO 2011/119101a1 or WO 2011/119100a1, both of which are incorporated herein by reference in their entirety for all purposes. The presently described link 100 is in the example attached to the mitral valve plane and assists in the movement of the link during the cardiac cycle, preferably substantially along the long axis of the heart. Thereby, other heart valves may be assisted as well to improve the heart function, such as the tricuspid valve.

Suitable arms 141,142,143 for attachment to a heart assist device are described in a concurrently filed patent application by the same applicant entitled "An implantable cardiac valve improved device, system and method". This patent application is incorporated herein by reference in its entirety for all purposes. In particular, when connected to the example of the chain annuloplasty ring 100 presently described herein, the content of the arms for connecting the annuloplasty ring to the heart assist movement generating unit is incorporated herein, in particular for the synergistic treatment of valvular regurgitation, preferably in addition to the stabilization purpose, and/or preferably in addition to the aforementioned "clipping" of valve tissue.

Alternatively or additionally, the ring 100 is connected to a heart valve replacement or repair unit via coupling units like arms 141,142, 143. Thus, a system is provided that includes an implantable medical device that includes an anchor unit (herein an example of a chained annuloplasty ring) configured to be permanently anchored at a heart valve of a patient. The system comprises at least one coupling unit for connecting the anchor unit to a further unit, such as a heart valve replacement or repair unit, preferably via a locking unit 140 attachable to said further unit. Thereby, the anchor unit is connected to further units, such as heart valve replacement or repair units, preferably to each other via the at least one coupling unit. Suitable arms 141,142,143 are described in a concurrently filed PCT patent application by the same applicant entitled "implantable heart valve improvement device, system and method", and claiming priority from european patent application No. EP18182804.7 filed under the same title on 7/10/2018 and U.S. patent application No. 16/0317327 filed under the same title on 7/10/2018. These patent applications are incorporated herein by reference in their entirety for all purposes. In particular, when connected to the example of the chained annuloplasty ring 100 presently described herein, the disclosure for connecting the arms 141,142,143 of the annuloplasty ring in combination with a heart valve replacement or repair unit via coupling units is incorporated herein, in particular for a synergistic treatment of valve regurgitation, preferably in addition to stabilization purposes.

In the example, the loop 100 has a closed loop shape when the opposite ends of the chain are brought together after deployment.

In some examples, annuloplasty link 100 may have a closed loop shape, such as a circle, an oval, a D-shape, or the like. When the chain 100 is unfolded, the two opposite end segments of the elongated chain 100 are suitably brought together and connected to each other so as to close the loop. The two end segments may be attached to each other by means of a suitable fastening unit. Alternatively or additionally, the two end segments may have magnetic properties of opposite polarity at the mating ends for magnetic closure of the chain 100 in the body at the heart valve. Link elements may be attached between the two end segments to close the chain 100 loop. Alternatively or additionally, closure may be provided by inserting elements that connect the first and last chain elements of the loop 100 together after deployment.

In an example, a system for deploying a chain implant 100 is provided. The system comprises: a multi-lumen catheter 150 having a first lumen 151 arranged to receive a retaining element for the chain implant 100; and at least one screwing tool 200 in the second lumen 152 of the multi-lumen catheter 150 for rotational engagement with the heads of the tissue anchors 120 in the chain ring 100, respectively.

In an example, a method of deploying a chain implant 100 is provided. The method comprises the following steps: the chain implant is delivered to the annulus of the heart valve, and the chain implant 100 is anchored to the annulus by screwing the screw anchor 120 into the annulus. In the case where the chained implant is not a pure anchor implant but is an annuloplasty implant, the method comprises: the chain implant 100 is optionally shortened for annuloplasty. The method further optionally comprises: the chain implant is stabilized by locking one or more arms 141,142, 143.

Figure 21 is a schematic view of an annuloplasty ring in an interior view as viewed from the lumen in the delivery catheter 155. Fig. 22 illustrates a delivery view of a chain annuloplasty ring with end segments of the chain protruding from the delivery catheter 155. Fig. 23a to 23c are schematic views of a percutaneous transcatheter approach to the heart. Fig. 24 a-24 b are schematic diagrams showing a direct access path to a heart valve via an incision in the skin and a puncture 95 in the apex of the heart. Fig. 25-26 are schematic diagrams depicting an example of a complete annuloplasty ring implantation of a medical device. Fig. 27 is a schematic view of a multi-lumen catheter 150 disposed in a delivery catheter 155 and an introduction catheter 123. Fig. 28 and 29 are cross-sectional views of two lumens in the multi-lumen catheter 150 from fig. 27.

In more detail, the delivery system for a medical device is shown with reference to fig. 23a, 23b, 23c, 24a and 24 b.

One access to the heart valve is through the venous system, as illustrated in fig. 23 a. Puncture of the great vein is performed at puncture site 95. The puncture site 95 may be the neck, chest or groin. Introduction conduit 123 is placed in position according to convention.

Another access to the heart valve is through the arterial system, where an introduction catheter 123 is placed in place as illustrated in fig. 23 c.

The third access to the heart valve is through a small incision in the chest wall directly into the heart, in particular the apex 26, where again an introduction catheter 123 is inserted as illustrated in fig. 24a) and 24 b).

Common to the different options for accessing the heart valve is the equipment of the catheter, tube and wire that make up the delivery system. A delivery system includes a first delivery catheter 155 that may have a link 100 loaded inside at the tip. Such a delivery catheter 155 typically has a length from a detachment site inside the human body to outside the body, which allows direct contact with the delivery site.

A push tube 132 having an outer diameter smaller than the inner diameter of delivery catheter 155 may be advanced axially within delivery catheter 155 to push chain ring 100 out of delivery catheter 155 at the desired site, preferably the annulus.

Alternatively, the delivery catheter 155 may be retracted over the push tube/catheter 132 to deliver the device without any axial movement.

The delivery system also includes a guidewire 124 that can guide the delivery catheter 155 to a desired site. The guidewire 124 may extend inside the delivery catheter 155, either near the device, or have a separate lumen in the diagnostic/guidance catheter 122.

Using similar techniques, link 100 is loaded inside delivery catheter 155 for insertion into a heart chamber, preferably into the left or right atrium of the heart. A space is housed inside the delivery catheter 155 for delivering and attaching the chain loop 100 adjacent to the heart valve.

After the chain loop 100 has been pushed out of the delivery catheter 155 by the pusher catheter 132, a multi (such as dual) lumen catheter 150 may be inserted into the delivery catheter 155. Alternatively, the multi-lumen catheter may already be inserted into the delivery catheter 155 and may first be used as the push catheter 132, i.e. in this case no additional push catheter 132 is needed. In the first lumen 151 of the multi-lumen catheter 150, a holding unit may be inserted to position and hold the chain ring 100 in place. In the second lumen 152 of the multi-lumen catheter 150, a suitable tool, such as a screwdriver 200, may be inserted using the guide catheter 122 to secure the tissue anchor 120 to the heart tissue.

The pusher tube 132 and/or delivery catheter 155 houses a lumen for the guidewire 124 that is also allowed to run inside or alongside the chain loop 100, or the pusher tube 132 and/or delivery catheter 155 alternatively has a separate lumen in the diagnostic/guiding catheter 122. The links 100 are released for permanent attachment to the heart valve tissue. One or more arms 141,142,143 may be housed in a delivery catheter 155.

In an example, a medical procedure of implanting a medical device as described herein is disclosed. The process includes the implementation of the elements described above. Initially, introduction catheter 123 is placed into the selected vessel or heart chamber. In all of the following description, introducer dilator 121 may also be used in conjunction with introducer catheter 123 to facilitate its insertion.

Different scenarios exist:

in a first scenario, venous access is illustratively depicted as fig. 23a, preferably the jugular vein on the neck, the subclavian vein on the chest, the femoral vein or more peripheral veins.

Once the introduction catheter 123 is in place, the diagnostic/guide catheter 122 is inserted through the introduction catheter 123 and placed near the delivery site adjacent the heart valve by means of the guidewire 124.

In-vivo navigation is guided by means of x-rays (such as fluoroscopy or CT-scans) and by means of ultrasound devices.

Leaving the guidewire 124 in place allows the delivery catheter 155 to travel over the guidewire 124 to the desired site. In the case where the tricuspid valve between the right atrium and right ventricle is the target, the guidewire 124 is positioned in the right atrium.

If the target is the mitral valve, transseptal puncture of the atrial septum 7 is performed as illustrated in fig. 23b, and penetration of the atrial septum between the left and right atria with the guidewire 124 and diagnostic/guide catheter 122 is required as illustrated in fig. 23 b.

Once the guidewire 124 is inside the left atrium, the guidewire 124 is left inside the left atrium. Over the guidewire 124, a delivery catheter 155 can be advanced over the guidewire 124.

If the aortic valve is the target, the guidewire 124 and delivery catheter 155 can be advanced through the mitral valve into the left ventricle from below facing the aortic valve.

In a second scenario, arterial access is preferred, as illustrated in fig. 23 c. Wherein the puncture of the aorta is given access to the aorta by means of an introduction catheter 123. With the aid of the guidewire 124 and the diagnostic/guidance catheter 122, the guidewire 124 is placed over or under the aortic valve, which allows the delivery catheter 155 to enter the desired delivery point.

If the mitral valve is the target, the guidewire 124 and diagnostic/guide catheter 122 can be advanced from the aorta into the left ventricle, even further from the left ventricle into the left atrium, to access the mitral valve from above as well as from below.

In a third scenario, as illustrated in fig. 24a) and 24b), it is desirable to access from the apex of the heart to directly access the heart valve. Preferably, the mitral and aortic valves are accessed through the left ventricular chamber and the tricuspid and pulmonary valves are accessed from the right chamber. Direct access to the surface of the heart is obtained through a small incision in the chest wall and pericardium.

If the mitral valve is the target, an introduction catheter 123 is inserted into the left ventricle and placed adjacent to the mitral valve, which gives access to the mitral valve and its annulus from above or below.

If introduction catheter 123 is in the left atrium, guidewire 124 may be used or deemed unnecessary.

Once the guidewire 124 or catheter is located near the insertion site, the procedure is equal for all scenarios, and therefore, only the medical device proposed herein for insertion of the mitral valve from the apex of the left ventricle will be described.

If the valve is native, with no implant adjacent to or in the valve, the process can be explained as follows:

with the guidewire 124 at a position adjacent to the valve, the delivery catheter 155 is advanced over the guidewire 124 to the insertion site. The link 100 is advanced through the delivery catheter 155, squeezed and deployed by means of the pusher catheter 132.

The link 100 is attached to or adjacent to the valve annulus using a tissue anchor unit 120. Such a link 100 may be provided with one or more already attached coupling units, such as arms 141,142,143, preferably flexibly attached for unfolding, by insertion. However, in the event that the coupling unit is not attached to the link implant 100, the coupling unit will be advanced to the link implant 100 through the delivery catheter 155 and secured to the link implant by means of the attachment unit.

Fixation by the tissue anchor 120 may be performed by introduction of a suitable tool (e.g., screwdriver 200) through the second lumen of the multi- (dual) lumen catheter 150.

Once assembly of the new medical device is completed inside the heart, the guidewire 124 and all catheters, including the introducer catheter 123, are withdrawn and the insertion site 95 is secured to prevent bleeding.

Fig. 30 to 42 are schematic step views of such a method for deploying the chain annuloplasty implant 100.

The above-described processes and methods have been successfully implemented to insert the chain ring implant 100 into an animal.

In another example, a method of treating a heart valve is provided. The method comprises the following steps: performing annuloplasty by shortening the anchored loop implant and preferably by patient-specifically adapting the curvature of the loop implant; optionally stabilizing the link implant with one or more arms 141,142, 143; and optionally connecting the arms to a heart valve tissue locking unit, a heart assist device or a valve repair or replacement unit.

Assembly of chain links

The assembly and installation of the separate segments 110 is illustrated with reference to fig. 43 a-43 b, 44 a-44 b, 45 a-45 b and 46.

The two chain segments 110 are brought together by first sliding the left side (first end 320) of the chain segment 110 in fig. 44a into the slit on the right side (second end 340) of the chain segment 110 in fig. 43 a.

The chain segments 110 are then locked together by inserting the attachment unit 350 in fig. 43a between the two chain segments 110, wherein e.g. a ratchet type snap-in locking element as in fig. 43a prevents the attachment unit 350 from falling out.

Once the chain segment 110 is assembled, the attachment unit 350 is included in the chain segment 110 and becomes an integral part of the chain segment 110.

In addition to locking the chain segments 110 together, the attachment unit 350 may also be configured to include a cooperatively arranged locking element 358 (see e.g., fig. 11, 14) for irreversibly shortening the overall length of two adjacent chain segments 110, such as a ratchet-type snap-in locking element as illustrated in fig. 43b, which, when assembled, mates with the corresponding snap-in teeth or ratchet 328 of the adjacent chain segments.

The attachment unit 350 can also be configured to include a tissue anchor 120, such as a tissue screw as illustrated in fig. 46, internally.

The next step in the assembly process is to insert the tissue anchor 120 through the

holes

346, 352 of the segment 110, exemplified by see fig. 43a and 43b, and/or the attachment units 350 included in the segment 110.

In some examples, the inserted tissue anchor 120 is arranged as a stop element that prevents unwanted shortening of two adjacent segments 110. For instance, if inserted into the hole 346, i.e. on the left side of the hole 354 in fig. 43a intended for the attachment unit 350, the tissue screw shown in fig. 46 will act as a screw stop, whereby an undesired shortening of two adjacent chain segments 110 will be prevented. Once the tissue anchor is moved to protrude from the chain element 110, the stop function is removed.

The next step in the assembly process may be to insert a pull cord 130 and/or a spring element 135, for example in the form of a spring, around a proximal portion of the wire with a threaded attachment element 136 at the other end of the wire, as illustrated in fig. 45a and 45 b.

The end 136 of the pull cord 130 including the attachment element is inserted into an aperture 348 on the top of the chain segment 110 in fig. 43a (i.e., the aperture to the left of the aperture 346, intended for screw stop). The attachment element 136 on the end of the pull cord 130 is then attached to the adjacent chain segment 110, such as by screwing the threaded attachment element 136 into the threaded hole 325 on the adjacent chain segment 110 or on one side of the attachment unit 350 included in the adjacent chain segment 110. Thus, the shortening of two adjacent segments 110 may be provided by: the pull cord 130 is pushed so as to move the two adjacent chain segments 110 toward each other to respectively reduce the overall length of the two adjacent chain segments 110.

Once all of the chain segments 110 are interconnected in series and hinged to the chain with all parts assembled, the chain can be loaded into the delivery catheter 155. To load the chain into the delivery catheter 155, the spring element 135 is pushed downward/rearward and the separated chain segments 110 are stretched such that the chain assumes its elongated delivery configuration, and then the chain is pushed into the delivery catheter 155.

The two figures 43b and 44b are the same figures as fig. 43a and 44a, but are shown from a different point of view where the chain segments have been turned 180 degrees.

Description of different chain configurations

At least part of annuloplasty ring 100 comprises a plurality of discrete segments 110 interconnected in series and hinged to a chain, having three distinct configurations as exemplified in fig. 47a, 47b and 47 c. The three different configurations are: a substantially elongated delivery configuration (fig. 47a), a curved pre-shortened deployed configuration (fig. 47b), and a shortened curved shape configuration having a smaller radius than the deployed configuration, i.e., an annuloplasty configuration (fig. 47 c).

The delivery configuration is obtained by pushing the spring element 135 downwards/backwards and then bending the separated chain segments 110 such that the chain assumes its substantially elongated delivery configuration, see fig. 47 a. The inner groove (i.e. the large hole) on the right side (i.e. the first end 320) of the segment 110 in fig. 47a has a widening in the hole on the right end, which widening bends the hole in a knee 326-shaped manner. The features of this particular knee 326 shape in the design of the chain segment 110 allow the chain segment 110 to bend and stretch in an almost straight manner, which results in a substantially elongated delivery configuration.

Once the spring element 135 has sprung back and pushed the separated chain segments 110 into a bent, predetermined state, the deployed configuration is obtained. The tissue anchor 120 is arranged to protrude from the chain segment 110 in the deployed configuration to anchor with cardiac tissue. In one embodiment of the invention, the tissue anchor 120 is arranged as a stop element that prevents unwanted shortening of two adjacent segments 110 when arranged at least partially within the segments 110 before being arranged to protrude from the segments 110. Such a stop element is obtained if a tissue anchor 120, such as the tissue screw illustrated in fig. 46, is included in the hole 346, i.e. shown on the right side of the attachment unit 350 in fig. 47b, whereby an undesired shortening of two adjacent segments 110 will be prevented.

The annuloplasty configuration is obtained by pulling the pull cord 130 so as to move the two adjacent segments 110 relatively towards each other, thereby reducing the total length of the two adjacent segments 110, respectively. Thus, an annuloplasty of the heart valve is obtained by shortening two adjacent segments 110. The annuloplasty configuration has a curved shape with a radius smaller than the radius of the curved deployed configuration, i.e. the annuloplasty configuration not only has a reduced overall length, but also a more curved shape than the shape of the deployed configuration, see fig. 47b and 47 c. When the locking elements 370, such as teeth 328/358, are engaged, the shortening is irreversible.

Collar/sock/stocking/pouch/bag/big bag

The annuloplasty ring 100 may be covered with, for example, a collar, sock, stocking, pouch, bag, or sack. The covering material may for example be at least partially constituted by polyethylene terephthalate (commonly abbreviated PET, PETE or discarded PETP or PET-P and may also be called the trademarks Terylene, Lavsan and Dacron), polytetrafluoroethylene (commonly abbreviated PTFE, or stretched/expanded PTFE also called ePTFE, also more commonly called the common trademark Teflon or the registered trademark Gore-Tex), polyurethane (commonly abbreviated PUR and PU and also commonly used for the manufacture of synthetic fibres, such as Spandex, Lycra or Elastane), other polyester materials, textile materials or any other biocompatible material. The covering material may be, for example, at least partially threaded, taped, tethered, sutured, sewn, or sprayed onto the annuloplasty ring 100.

The covering material may completely surround the segments 110, covering the entire annuloplasty ring 100, but need not always cover all the way around the segments 110, and may, for example, cover only the sides and/or bottom of the annuloplasty ring 100. The top of the tissue anchor 120, such as the tissue screw in fig. 46, may protrude through the covering material to provide easy access to the screw head. Alternatively, the top of the annuloplasty ring 100 may remain uncovered, or there may be holes in the cover material over the holes containing the tissue anchors 120, to provide easy access to the top of the tissue anchors 120.

The covering material has several particular advantages, such as the covering material can be configured to promote better ingrowth of the annuloplasty ring 100, the covering material can be configured to avoid any sharp edges of the annuloplasty ring 100, and/or the covering material can be configured to avoid any heart tissue around the annuloplasty ring 100 from being squeezed as the segments 110 are shortened. The cover material may also improve the sealing of the links to the valve tissue. Thereby, it may alternatively or additionally prevent or reduce possible backflow of blood.

Stabilization of annuloplasty ring 100 with foreshortening

In some examples, the plurality of separate chain segments 110 interconnected in series and hinged to the chain 100 are flexible relative to each other in the deployed configuration. The flexibility is configured to allow the different segments 110 to easily follow the annulus of the heart valve in order to facilitate anchoring of the tissue anchor 120 in the annulus.

Once the annuloplasty ring 100 is anchored in the annulus of the heart valve, in the illustrated example, annuloplasty of the heart valve is obtained by pulling the drawstring 130 so as to move the adjacent segments 110 relatively towards each other, thereby reducing the overall length of the adjacent segments 110, respectively.

The shortening of adjacent segments 110 is configured to stabilize the separate segments 110 relative to one another, whereby the flexibility in the deployed configuration is adjusted away from the annuloplasty ring 100 to the flexibility of the annuloplasty configuration.

Locking elements 370 included in the segments 110 for irreversible shortening, such as a mating arrangement provided by teeth 328/358 of a mating and engaging arrangement, may be configured to achieve stabilization of the annuloplasty ring 100. The locking element 370 may for example be a ratchet type snap-in locking element as illustrated in fig. 43a and 43 b. The locking element 370 comprising a mating arrangement in the segment 110 for irreversible shortening may also be configured to obtain flexibility of the detached segment 110, wherein said locking element 370 may snap into the locking element, such as e.g. a tapered and/or conical shape of the ratchet type as exemplified in fig. 43a and 43 b.

Individualization

In one embodiment of the present invention, the segments 110 are arranged to be individually shortened relative to adjacent segments 110, respectively, such that the curvature of the annuloplasty ring 100 may be adjusted differently at different interconnecting segments 110. Thereby, different adjacent segments 110 may be shortened differently, i.e. the relative movement towards each other may be different for different adjacent segments 110. The reduction in the total length of two adjacent segments 110 may be anything from none to the maximum allowable reduction. In this way, the annuloplasty ring 100 may be individualized for each patient because the same annuloplasty ring 100 may be shortened in multiple ways. Thus, the same annuloplasty ring 100 may be used for different patients having different needs for annuloplasty, as the annuloplasty ring 100 is configured to be adaptable and have the ability to be customized to the needs of an individual annuloplasty. Personalization and customization of the shortening of the annuloplasty ring 100 may be performed during ongoing heart valve treatment, for example by changing the shortening at different locations until the leak in the heart valve disappears.

Anchoring at cardiac tissue

The tissue anchor 120 may be arranged to protrude from the chain segment 110 by means of, for example, a screwdriver or some other suitable tool, which may be inserted into the correct position, for example, with a multi/double lumen catheter 150. Alternatively, each tissue anchor 120 can be configured, for example, to include a wire, chain, rope, or wire attached to the top of the tissue anchor 120. Each tissue anchor 120 is then arranged to protrude from its chain segment 110 by turning, twisting and/or pushing each attached wire, chain, string or thread. In one embodiment of the present invention, the wire, chain, string or thread is configured to be automatically and/or manually detached and removed from the top of the tissue anchor 120 once the tissue anchor 120 is anchored at the cardiac tissue.

The screwing tool 200 can be pre-mounted to one or more tissue anchors 120 prior to insertion into the delivery catheter 155. In this way, navigation and positioning of the various tissue anchors 120 is not required. Thus, the individual tissue anchors may also be individually anchored in a desired sequence for improved and rapid anchoring. After anchoring tissue anchor 120 at the heart tissue, pre-installed driver tool 200 may be automatically or manually removed.

For example, examples of manually detachable pre-mounted turning tools 200 are shown in fig. 48 a-48 d, 50 b-50 c, and/or 49 d. In more detail, an example of pre-mounting the screwing tool 200 to each tissue anchor 120 is illustrated.

After the tissue anchor 120 is anchored at the cardiac tissue, the pre-installed screwing tool 200 is detachable, illustrated in fig. 50 b-50 c and/or 49 d. A detailed illustration of the head of one of the turning tools 200 engaged with the head of the tissue anchor 120 is shown in fig. 50 c. Here, the tissue anchor 120 is screwed clockwise into place in the heart tissue by rotating the screwing tool 200 clockwise. The head of the screwing tool 200 and the head of the tissue anchor 120 are matingly threadedly engaged and are arranged to rotate together as a unit, i.e., "lock" together in at least a clockwise direction. By rotating the screwing tool 200 in the opposite rotational direction (here, counterclockwise), the head of the screwing tool 200 can be unscrewed from the head of the tissue anchor 120.

The rotation stop member 220 abuts against the seat 230 to prevent rotation in one direction. Once the head of the tissue anchor 120 has reached the bottom of the chain segment 110, the rotation stop element 220 is automatically released into the hole in the bottom of the chain segment 110 (where the thread for the tissue anchor is arranged). Thus, by rotating the screwing tool 200 clockwise until the desired engagement or fixation is obtained, the tissue anchor 120 may be screwed into the segment 110. Stop element 220 does not prevent counterclockwise rotation of screwing tool 200 relative to the head of tissue anchor 120. The end of the stop element 220 is arranged to abut against the seat in a counter-clockwise direction, thereby allowing the threaded locking of the head 120a of the tissue anchor 120 with the head 210 of the screwing tool 200 to be released by a counter-clockwise rotation of the screwing tool 200.

The rotation stop element 220 will allow the tissue anchor 120 to still rotate freely clockwise in the segment 110, but will be locked from rotation in the opposite rotational direction. If the head 210 of the turning tool 200 is rotated counterclockwise, the rotation stop element 220 will face the seat 230 in the bore of the chain segment 110. Once rotational stop element 220 faces seat 230, tissue anchor 120 and head 210 of screwing tool 200 are unlocked counterclockwise relative to one another. Screwing tool 200 will be able to be detached from head 120a of tissue anchor 120 by continued counterclockwise rotation. Screwing tool 200 can be detached from head 120a of tissue anchor 120, e.g., using threads, as illustrated in fig. 50 b. After being fully unscrewed, the screwing tool 200 may be removed from the patient.

The tissue anchor 120 is free to rotate in any direction as long as the head 120a of the tissue anchor is not engaged in the bottom of the segment 110. This means that the tissue anchor can be advantageously repositioned (by rotating in a counter-clockwise direction in this example) if desired. The head 120a of the tissue anchor 120 and the head 210 of the screwing tool 200 may be screwed together in this manner: the stop elements do not unscrew from each other until they prevent the head 120a of the tissue anchor 120 from rotating in one direction. Also, the skilled person understands that the exemplary rotation directions may be chosen as desired.

In some examples, the rotation stop element 220 abuts the seat 230 on both sides of the rotation stop element 220 to prevent rotation in both directions. Once the head of the tissue anchor 120 reaches the bottom of the chain segment 110, the rotation stop element 220 is automatically released into the hole at the bottom of the chain segment 110, which contains the seat 230 on both sides or around the rotation stop element 220. Once the rotational stop element 220 faces the seat 230 in the bore of the segment 110, the tissue anchor 120 is rotationally locked in both directions. This may allow for easy removal of the screwing tool 200 from the head 120a of the tissue anchor 120, for example, by continued rotation in any direction.

In some examples, the pre-installed screwing tool 200 is automatically disassembled after the tissue anchor 120 is anchored at the cardiac tissue. Thus, the pre-installed screwing tool 200 is configured to be (automatically) detachable from the tissue anchor while securely anchoring the tissue anchor in the tissue. For example, once the head of the tissue anchor 120 has reached the bottom of the chain segment 110, the rotation stop element 220 automatically releases into the hole in the bottom of the chain segment 110, which automatically releases the screwing tool 200 from the head of the tissue anchor 120. For example, automatic release of screwing tool 200 from the head of tissue anchor 120 may be provided by release of a pin or latch arrangement into a hole triggered by rotation stop element 220. Furthermore, a predetermined breaking point may be provided in the connection of the screwing tool to the tissue anchor, such as when the rotational threshold force is exceeded when the rotational stop element 220 is released into the hole so as to prevent rotation in at least one direction. After the automatic release, the turning tool 200 may be removed from the patient.

In some examples, the tissue anchor 120 may be arranged to protrude from the segment 110 only when in contact with cardiac tissue. For example, the rotational force required on screwing tool 200 to rotate tissue anchor 120 is provided to be different when tissue anchor 120 is in or out of contact with cardiac tissue. A higher rotational force is required when the tissue anchor 120 is in contact with the heart tissue than with blood. Thus, if the rotational force required is too low, the tissue anchor 120 will not protrude from the segment 110. The rotational force is dependent on the media surrounding the anchor portion of the tissue anchor 120. For example, soft or cartilaginous tissue provides a higher rotational resistance than fluid. Once a high rotational force is imparted, the tissue anchor is pulled from the chain into the tissue. On the other hand, rotation of the tissue anchor with the surrounding fluid/blood does retain the tissue anchor in the segment 100, except for, for example, the sharp tip of the tissue anchor. The tip may protrude slightly to engage with tissue and then protrude by rotational engagement with the tissue. This "sensitivity" of the surrounding medium has many advantages, such as safe anchoring in the tissue only, avoidance of inadvertent release of the anchoring elements during deployment of the loop 100, and/or safe delivery through a delivery catheter, etc.

In an example, a deployment device for such a chained implant 100 described herein is provided. The deployment device comprises: a multi-lumen catheter 150 having a first lumen 151 arranged to receive a retaining element for the chain implant 100; and at least one screwing tool 200 in the second lumen 152 of the multi-lumen catheter 150 for rotational engagement with the heads of the tissue anchors 120 in the chain loop 100, respectively.

Short operation time

A particular advantage of the present invention is that the surgical procedure time for annuloplasty treatment will be short, since the tissue anchor 120 is at least partially integrated within the segment 110 from the beginning, and the surgeon does not need additional time to insert the tissue anchor 120 into the segment 110.

Open loop

In an example, when deployed, annuloplasty ring 100 may have an open curved shape. Annuloplasty ring 100 may have an open ring shape, for example, the shape may be at least partially circular, semi-circular, at least partially elliptical, semi-elliptical, or semi-elliptical. The two opposing end segments 110 of the elongated chain may point toward each other in the same direction, slightly away from each other, or anything in between. Annuloplasty ring 100 may have a symmetrical shape or an asymmetrical shape.

An example of a chain ring 100 having one arm 141 and a pre-installed retainer 170 is illustrated in fig. 49a to 49 e.

The retainer 170 may be removable, for example in a similar manner to that described in connection with fig. 50 b-50 c and/or 49 d. Thus, after deployment, the retainer 170 may be removed from the patient.

If the retainer 170 is disassembled, the arms 141 may also be disassembled, or folded back toward the chain ring 100, or left in the deployed/open position. If the arms 141 are left in the deployed/open position, the arms 141 may later be used as coupling units for connecting said links 100, for example, to at least one locking unit 140 for fixing the tissue of the heart valve and/or fixing at least a part of the shape of the links 100 and/or to another unit, preferably a heart valve replacement or repair unit and/or a drive unit, such as a heart assist device.

The retainer 170 may alternatively remain attached to the arm 141 as the link 100 is deployed. The arms then serve subsequently as, for example, an extension unit or a further unit, preferably a heart valve replacement or repair unit and/or a drive unit, such as a heart assist device, or are arranged to secure at least one leaflet and/or chordae tendinae to the extension unit to limit its range of motion during the cardiac cycle.

A substantially elongated delivery configuration of the link 100 with one arm 141 and a pre-installed retainer 170 is illustrated in fig. 49 a. Also illustrated in fig. 49a is a threaded locking unit 140 in one end of the arm 141, e.g. for attaching and/or detaching the holder 170 to/from the arm 141.

As exemplified in fig. 49c, for example, one or more tissue anchors 120 can be oriented in other orientations than substantially perpendicular to the plane extending from deployed link 100. For example, one or more tissue anchors 120 can be angled such that the tissue anchors point radially outward from link 100. This allows for improved anchoring in the heart tissue, as the tissue anchor 120 may reach the target area with a more suitable anchoring capability.

The invention has been described above with reference to specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. The scope of the invention is only limited by the appended patent claims.

List of reference numerals

1 Structure of the heart

2 Superior Vena Cava (SVC)

3 subclavian vein

4 Right Atrium (RA)

5 foramen ovale

6 Coronary Sinus (CS)

7 house partition

First part of 8 CS

10 Inferior Vena Cava (IVC)

12 heart vena cava (GCV)

14 left atrial chamber (LA)

16 LA wall

18 Mitral Valve (MV) ring

19 whole mitral valve

20 anterior leaflet of mitral valve

21 posterior leaflet of mitral valve

22 left ventricular muscle wall

24 papillary muscles connected to the chordae tendineae

26 left ventricular apex

28 aortic valve

30 ascending aorta

32 ventricular septum

34 left ventricular cavity

36 right ventricle cavity

37 abdominal and thoracic aorta

38 right ventricular muscle wall

39 iliac or femoral artery

40 tricuspid valve

48 heart valve plane

49 heart axis

95 puncture site

100-segment annuloplasty ring 100

110 chain segment

118 opposite secondary seats

119 bayonet lock base

120 tissue anchor/stop screw

120a tissue anchor 120 head

121 introducing dilator

122 diagnostic/guide catheter

123 introduction catheter

124 guide wire

130 metal wire and pull rope

132 push tube/push catheter

134 spring element retainer

135 spring element

136 wire end (may include an attachment element)

140 locking unit

141. 142,143 lockable arms

145 for securing the eyelet of the tether 160

150 multi (e.g. double) lumen catheter

151 first lumen of catheter 150

152 second lumen of catheter 150

153 sealing valve

155 delivery catheter

160 fixed tether

170 holder

200 screwing tool

210 turning tool head

220 rotation stop element

230 seats at the bottom of the chain segment 110

241. 242, 243, 244 arm

320 first end of segment 110

322 first axis

324 second axis

325 for the bore of the wire end 136

326 knee

328 teeth

330 toe part

331 gap

340 second end of segment 110

342 slot

343 stop member

344 rounded end

346 second anchor hole

348 spring attachment holes

350 attachment unit

352 first anchor eye

354 oval hole

358 attachment unit teeth

360 degree of curvature

370 locking element for chain segment

Claims

1. An annuloplasty ring (100) for use in transcatheter heart valve treatment, at least in part, comprising a plurality of separate segments (110) interconnected in series and articulated to form a chain (100), said chain (100) having a substantially elongated delivery configuration and a curved deployed configuration,

at least one of the segments (110) comprises at least one attached tissue anchor (120), the tissue anchor (120) being at least partially movably arranged within the segment (110) in the delivery configuration and arranged to protrude from the segment (110) in the deployed configuration for anchoring with cardiac tissue.

2. The annuloplasty ring (100) according to claim 1, wherein the tissue anchor (120) is connected to the segment (110) and comprises a helical or threaded tissue anchor.

3. The annuloplasty ring (100) according to claim 1, wherein the tissue anchor (120) is lockable in the segments (110) in a longitudinally compressed state.

4. The annuloplasty ring (100) according to claim 1, the annuloplasty ring (100) having a ring shape with a flexible curvature in an unlocked state by the segments (110) being hinged to each other by joint segments, and the ring (100) being rigid in a transverse direction of the curvature by each of the joints being rotatable in only one plane, respectively.

5. Annuloplasty ring (100) according to claim 1, wherein the chain (100) has a chain length which is adjustable by at least two adjacent chain segments (110) being arranged shortened with respect to each other, and/or wherein at least one chain segment (110) is longitudinally curved and arranged to be shortened with respect to an adjacent joined chain segment (110), such that a curvature of the joined segments is adjustable when the length of two joined chain segments is shortened.

6. Annuloplasty ring (100) according to claim 5, comprising more than two preferably curved chain segments (110) arranged to be individually shortened with respect to adjacent chain segments (110), respectively, such that the curvature of the ring (100) is differently adjustable at different interconnected chain segments (110).

7. The annuloplasty ring (100) according to claim 5, wherein adjacent segments (110) comprise cooperatively arranged locking elements (370) for irreversible shortening of the total length of both of said adjacent segments (110), such as snap-in locking elements (328, 358).

8. The annuloplasty ring (100) according to claim 1, wherein the tissue anchor (120) is arranged as a stop element preventing shortening of two adjacent segments (110) when arranged at least partially within the segments (110) before being arranged to protrude from the segments (110).

9. The annuloplasty ring (100) according to claim 1, wherein the tissue anchor (120) is a stop screw preventing shortening of two adjacent segments (110) in the delivery configuration, wherein the stop is removed when screwing the stop screw (120) into adjacent annulus tissue in the deployed configuration.

10. The annuloplasty ring (100) according to claim 1, wherein the curved, deployed configuration of the ring (100) is provided by: actuating spring elements (135) between adjacent segments (110) inward such that the ring (100) is configured to flex from the delivery configuration to the curved deployed configuration having a shape of a first radius of curvature while restricting deployment of a delivery catheter (155).

11. The annuloplasty ring (100) according to claim 1, wherein the ring is adjustable from a first curved deployed configuration to a second smaller radius curved shape for the annuloplasty when deployed.

12. The annuloplasty ring (100) according to claim 1, wherein the ring (100) comprises at least one lockable arm (141) for stabilizing the ring (100) at the annulus.

13. Annuloplasty ring (100) according to claim 12, wherein the lockable arm (141) has a first end pivotably attached to the ring (100) at a first circumferential position of the ring (100) and pivotable in the direction of the center of the ring (100), wherein the arm (141) has an opposite second end comprising a locking unit (140) such that at least a part of the shape of the ring (100) is fixed when the arm (141) is locked by the locking unit (140) with respect to a second circumferential position of the ring (100).

14. Annuloplasty ring (100) according to claim 1, wherein the ring (100) comprises a plurality of lockable arms (141, 142, 143) which are lockable to each other at the second end, respectively.

15. The annuloplasty ring (100) according to claim 1, wherein the ring (100) has a closed ring shape when opposite ends of the chain are brought together after deployment.

16. The annuloplasty ring (100) according to claim 1, comprising at least one arm (141), wherein the ring (100) is connectable to leaflet tissue via the at least one arm (141) to restrict movement of the leaflet tissue; and/or the ring is connectable to a heart assist device to support movement of the heart valve; and/or the ring is connectable to a heart valve replacement or repair unit via the arms (141).

17. The annuloplasty ring (100) according to claim 1, wherein the tissue anchor (120) comprises a rotation stop element (220) arranged to rotationally abut against a seat (230) to prevent rotation of the tissue anchor (120) in one rotational direction.

18. The annuloplasty ring (100) according to claim 17, wherein the tissue anchor (120) is free to rotate until the rotation stop element (220) abuts the seat (230).

19. A medical implantable device for anchoring at heart valve tissue, the medical implantable device comprising: a plurality of separate chain segments (110) serially interconnected and hinged to a chain (100), the chain (100) having a substantially elongated delivery configuration and a curved deployment configuration; and at least one arm which can be attached or attached, preferably pivotably attached, to one of the segments, and

at least one of the segments (110) preferably comprises at least one attached tissue anchor (120), the tissue anchor (120) being at least partially movably arranged within the segment (110) in the delivery configuration and arranged to protrude from the segment (110) in the deployed configuration for anchoring with cardiac tissue.

20. A deployment device for a chain implant (100), such as according to any one of claims 1 to 17, comprising: a multi-lumen catheter (150) having a first lumen (151) arranged for receiving a retaining element for the chain implant (100); and at least one screwing tool (200) in the second lumen (152) of the multi-lumen catheter (150) for rotational engagement with the heads of the tissue anchors (120) in the chain loop (100), respectively.

21. The deployment device of claim 20, wherein the chain implant is the chain implant of claim 17 or 18, and wherein the screwing tool and the tissue anchor are securely and releasably connected to each other when deployed, and wherein the screwing tool is releasable from the tissue anchor (120) once the stop element prevents rotation of the tissue anchor in one direction.

22. Deployment device according to claim 20 or 21, comprising at least two arms (241, 242, 243, 244) having a pre-bent deployment configuration, such as pre-bent wires, and being arranged as spring elements (135), whereby the link (100) is configured to flex back from the delivery configuration to the bent deployment configuration.

23. The spreading device according to claim 22, wherein each of said at least two arms (241, 242, 243, 244) is respectively comprised in one of said screwing tools (200).

24. The deployment device according to any of claims 20 to 23, wherein the spatial orientation of at least some portions of the links (100) with respect to the longitudinal axis of their delivery lumens is adjustable upon deployment.

25. The deployment device according to claim 24, wherein said arms (241, 242, 243, 244) are arranged to provide said adjustable spatial orientation.

26. Deployment device according to any one of claims 20 to 25, comprising a removable holder (170) comprising an arm (141) pre-mounted to said link (100).

27. The deployment device according to claim 26, wherein said arm (141) is detachable from said link, such that said holder (170) and arm (141) can be removed when said link (100) is deployed.

28. The deployment device according to claim 26, wherein said arms (141) are detachable from said holders (170) and permanently connected to said links (100).

29. The deployment device according to claim 26, wherein the holder (170) and the arm (141) are permanently connected to the link (100).

30. A segment (110) for a medical implant, the segment comprising:

-at least one arm (141, 142, 143) attachable or attached, preferably pivotably attached, to the segment (110), the segment having a longitudinal extension and the arm being arranged along the longitudinal extension in a first configuration and arranged extending radially outwards from the segment in a second configuration; and/or

-at least one attached tissue anchor (120), the tissue anchor (120) being at least partially movably arranged within the chain segment (110) in a first configuration and arranged to protrude from the chain segment (110) to anchor with cardiac tissue in a second configuration.

31. A method of deploying a chain implant, preferably for use in annuloplasty, such as a chain implant according to any of claims 1 to 17, the method comprising: providing a chain implant (100);

delivering the chain implant to an annulus of a heart valve;

anchoring the chain implant (100) to the annulus by screwing a screw anchor (120) into the annulus; and optionally shortening the chain implant (100) for the annuloplasty; and/or

Optionally, the chain implant (100) is stabilized by locking one or more arms (141, 142, 143) having a fixed or adjustable length to the implant.

32. A method of treating a heart valve, the method comprising:

performing annuloplasty by shortening the anchored loop implant and preferably by patient-specifically adapting the curvature of the loop implant;

-optionally, stabilizing the link implant with one or more arms (141, 142, 143); and

-optionally, connecting the arms to a heart valve tissue locking unit, a heart assist device or a valve repair or replacement unit.

33. An annuloplasty ring (100) for use in transcatheter heart valve treatment, at least in part, comprising a plurality of separate segments (110) interconnected in series and articulated to form a chain (100), said chain (100) having a substantially elongated delivery configuration and a curved deployed configuration,

at least one of the segments (110) comprises at least one attached tissue anchor (120), the tissue anchor (120) being at least partially movably arranged within the segment (110) in the delivery configuration and arranged to protrude from the segment (110) in the deployed configuration for anchoring with cardiac tissue, and wherein,

the substantially elongated delivery configuration is a substantially straightened elongated delivery configuration of the annuloplasty ring (100).

34. An annuloplasty ring (100) for use in transcatheter heart valve treatment, at least in part, comprising a plurality of separate segments (110) interconnected in series and articulated to form a chain (100), said chain (100) having a substantially elongated delivery configuration and a curved deployed configuration,

the chain (100) has a chain length which can be adjusted by at least two adjacent chain segments (110) being arranged to be shortened with respect to each other.

35. An annuloplasty ring (100) for part of a transcatheter heart valve treatment, comprising a plurality of separate segments (110) interconnected in series and articulated to form a chain (100), said chain (100) having a substantially elongated delivery configuration and a curved deployed configuration, at least one of said segments (110) comprising at least one attached tissue anchor (120), said tissue anchor (120) being at least partially movably arranged within said segment (110) in said delivery configuration and arranged to protrude from said segment (110) in said deployed configuration for anchoring with heart tissue.

36. An annuloplasty ring (100) for use in transcatheter heart valve treatment, at least in part, comprising a plurality of separate segments (110) interconnected in series and articulated to form a chain (100), said chain (100) having a substantially elongated delivery configuration and a curved deployed configuration,

at least one of the chain segments (110) comprises at least one attached tissue anchor (120), the tissue anchor (120) being at least partially movably arranged within the chain segment (110) in the delivery configuration and arranged to protrude from the chain segment (110) to anchor with cardiac tissue in the deployed configuration, and wherein the anchor is arranged to be rotationally moved from the delivery configuration to the deployed configuration, preferably in a direction substantially perpendicular to a longitudinal extension of the chain segment.

37. An annuloplasty ring (100) for use in transcatheter heart valve treatment, at least in part, the annuloplasty ring comprising: a plurality of separate chain segments (110) interconnected in series and articulated to form a chain (100), the chain (100) having a substantially elongated delivery configuration and a curved deployed configuration,

at least one of the segments (110) comprises at least one attached tissue anchor (120), the tissue anchor (120) being at least partially movably arranged within the segment (110) in the delivery configuration and arranged to protrude from the segment (110) in the deployed configuration for anchoring with cardiac tissue; and

at least one arm pivotably attached or attached to one of the segments.

38. An annuloplasty ring (100) for use in transcatheter heart valve treatment, at least in part, the annuloplasty ring comprising: a plurality of separate chain segments (110) interconnected in series and articulated to form a chain (100), the chain (100) having a substantially elongated delivery configuration and a curved deployed configuration; and

-at least one arm (141, 142, 143) attachable or attached, preferably pivotably attached, to said segment (110), said segment having a longitudinal extension and said arm being arranged along said longitudinal extension in a first configuration and arranged extending radially outwards from said segment in a second configuration, wherein said ring (100) is reinforced or locked to a non-flexible configuration by said at least one arm (141, 142, 143) after deployment.