Field of the invention

[0001] The invention relates to an apparatus, a kit of parts and a method for annuloplasty of the mitral valve in a patient body.

Description of prior art

[0002] Document US20120290077A1 describes tissue retaining systems and devices and methods of using such devices. In particular, this document describes a tissue restraining device comprising an annuloplasty member for attachment to a valve annulus; an anchor configured to be located in spaced-apart relation to the annuloplasty member; and a restraint matrix comprising at least one wire extending between the annuloplasty member and the anchor. A method of installing the device by means of catheter that penetrates the left atrium from the coronary sinus is also described, wherein a steerable catheter is used to enter the left atrium from the coronary sinus. The distal end of the catheter may include a balloon configured to stabilize the catheter in the coronary sinus. An implant is configured to hold at least one suture attached to an anchor for attaching the suture to tissue in the left ventricle of the patient. A first arm of the implant may be placed in a coronary sinus and a second arm may be placed in the left atrium, and the arms may be biased toward each other to pinch the common wall between the coronary sinus and the left atrium, thereby securing the tissue retainer in place proximate a mitral valve.

[0003] US20050216039A1 describes a system and method for catheter-based repair of cardiac valves, including transcatheter-mitral-valve-cerclage annuloplasty and transcatheter-mitral-valve reapposition. An exemplary embodiment of the system includes: a guiding catheter, one or more secondary catheters, such as a valvemanipulation catheter and one or more optional suture-clip-pledget assemblies, and/or a canalization-needle catheter. Imaging methods and devices may be used to assist the operator of the system in determining the placement and orientation of the system within a subject's body. One exemplary imaging method is real-time magnetic-resonance imaging. A suture is described which extends through the coronary-sinus ostium into the coronary sinus and crosses the left atrium from a postero-lateral portion to an anterior portion of the mitral valve annulus and back. The resulting suture provides sufficient tension to reappose the anterior leaflet of the mitral valve and the posterior leaflet of the mitral valve without significantly interfering with the opening or closing of the mitral valve during its movement. In another example, suture clips or tension sutures may be implanted on the atrial surface of the mitral valve and connected to the bases of the anterior and posterior leaflets of the mitral valve.

[0004] Document W02007/029252 describes a device for reducing the anteroposterior diameter of a patient's body mitral annulus. The device includes a first anchor attached to an anterior region of the mitral annulus and a second anchor attached to a posterior region of the mitral annulus, and a displacement reduction mechanism coupled to the first and second anchors. The displacement reduction mechanism displacing the first and second anchors toward each other when said displacement reduction mechanism is exposed to energy emitted from an energy source is located outside the heart, such as by magnetic radiation.

[0005] Transcatheter mitral valve repair is known in the art as a way to reduce the invasiveness of the associated surgery. However, it usually involves suturing the mitral valve annulus and or the use of implants with complex shape.

[0006] There is a need for an apparatus, a kit of parts and a method for transcatheter mitral valve repair with reduced invasiveness and easier to position in the body of the patient, while still providing flexibility in the modification of the shape of the mitral valve of the patient.

Summary of the invention

[0007] It is an object of the present invention to provide an apparatus, a kit of parts and a method for repairing the mitral valve and in particular for improving coaptation of the mitral valve leaflets by modifying a shape of the mitral valve annulus. The invasiveness of the apparatus and method is reduced by holding portions of the mitral annulus with threads coupled to anchors fastened to the mitral annulus anterior part in the left atrium and to an implant almost entirely positioned in the coronary sinus of the patient.

[0008] The invention is defined by the independent claims. The dependent claims define advantageous embodiments.

[0009] In a first aspect, the invention relates to an apparatus for permanent annuloplasty of a mitral valve in a patient body, comprising: a set of anchoring elements comprising one or more anchoring elements configured for fastening to an anchoring site in a vicinity of the mitral valve anterior annulus of the patient body, • a thread traversing a passage through a left atrium wall separating a coronary sinus from a left atrium, and coupled to the one or more anchoring elements and attached to,

• an implant configured for being substantially entirely positioned in the coronary sinus and in the passage.

[0010] In a preferred embodiment of the apparatus according to the invention, the anchoring site is located in the vicinity of the mitral valve anterior annulus, and preferably at a level of a left fibrous trigon, or a right fibrous trigon, or substantially equidistant from the left and right fibrous trigon.

[0011] In a preferred embodiment of the apparatus according to the invention, the passage through the left atrium wall is at a level of a mitral valve posterior annulus, preferably in the P2 area.

[0012] In a preferred embodiment of the apparatus according to the invention, the thread extends between a first end and a second end of the thread, and:

• the first and second ends of the thread are attached to the implant, and at least one of the one or more anchoring elements is configured for sliding along the thread, or at least one of the one or more anchoring elements is configured for attaching and remaining stationary with respect to the thread,

• the first end of the thread is attached to the implant and the second end of the thread is coupled to the one or more anchoring elements.

[0013] In a preferred embodiment of the invention, the apparatus comprises a first and a second set of anchoring elements fastened to separate first and second anchoring sites, respectively, the first and a second set of anchoring elements each comprising one or more first and second anchoring elements, respectively.

[0014] In a preferred embodiment of the apparatus according to the invention, the first and second anchoring elements are coupled to a same or to separate threads, and all the threads are attached to the implant and pass through the passage.

[0015] In a second aspect, the invention concerns a kit of parts for annuloplasty of a mitral valve in a patient body, comprising:

• an anchoring catheter extending between an anchoring catheter proximal portion and an anchoring catheter distal portion, and configured for inserting into a patient body up to the anchoring catheter distal portion penetrates from a coronary sinus into a left atrium through a passage in a left atrium wall separating the left atrium from the coronary sinus, the anchoring catheter comprising a suture lumen comprising a suture lumen distal aperture comprised in the anchoring catheter distal portion,

• an apparatus as described here before, o the thread being configured for running through the suture lumen of the anchoring catheter, o the implant comprising an implant thread lumen configured for passing the thread, and a locking mechanism movable from at least a release position to a holding position wherein the locking mechanism is configured for allowing or preventing the implant to thread over the thread in at least one direction, respectively

[0016] The implant is configured for contacting a portion of the coronary sinus in a vicinity of the passage to close the passage, and for adjusting a distance separating the anchoring site from a portion of the left atrium wall in a vicinity of the passage by adjusting a position of the implant along the thread passing through the passage.

[0017] In a preferred embodiment of the invention, the kit of parts comprises a stabilizing catheter extending along a stabilizing catheter longitudinal axis between a stabilizing catheter proximal portion and a stabilizing catheter distal portion and comprising:

• a working lumen comprising a working lumen distal aperture comprised in the stabilizing catheter distal portion,

• preferably a guiding lumen configured for threading the stabilizing catheter over a first guidewire, the stabilizing catheter being configured for threading over the first guidewire and in the patient body up to positioning the stabilizing catheter distal portion in the coronary sinus of the patient body at a level of the passage through the left atrium wall, and the anchoring catheter of the kit of parts being configured for running through the working lumen of the stabilizing catheter.

[0018] In a preferred embodiment of the invention, the kit of parts comprises:

• a needle comprising a needle tip and configured for piercing and creating the passage through the left atrium wall, and preferably for running the first guidewire or a second guidewire through the needle and the needle tip,

• a dilator, preferably configured for running through the working lumen of the stabilizing catheter, the dilator comprising: o a dilator lumen comprising a dilator lumen distal aperture, and configured for running the needle through the dilator lumen distal aperture between a retracted and a deployed position wherein the needle tip is in and out of the dilator lumen, respectively, o a dilator distal tip comprising the dilator lumen distal aperture and configured for passing through the working lumen distal aperture and through the passage, and for widening the pierced passage.

[0019] In a preferred embodiment of the kit of parts according to the invention, the anchoring catheter comprises an anchoring catheter guiding lumen configured for threading the anchoring catheter over the first guidewire or the second guidewire, and the anchoring catheter distal portion is configured for passing through the working lumen distal aperture and through the passage.

[0020] In a preferred embodiment of the kit of parts according to the invention, the implant comprises an implant guiding lumen configured for passing the first guidewire and/or second guidewire, the implant being configured for threading over at least one of the first guidewire and/or second guidewire, and over the thread, up to the coronary sinus at a level of the passage.

[0021] In a preferred embodiment of the invention, the kit of parts comprises an implant catheter comprising an implant catheter lumen configured for passing the first guidewire or the second guidewire or both the first and second guidewires, the implant catheter being configured for threading over the first guidewire or the second guidewire or both the first and second guidewires and for pushing the implant along the first guidewire or the second guidewire or both the first and second guidewires up to positioning the implant in the coronary sinus.

[0022] In a preferred embodiment of the invention, the kit of parts comprises a working catheter comprising:

• a working catheter lumen comprising a working catheter lumen distal aperture and configured for alternatively passing the dilator and the anchoring catheter up to the dilator distal tip and the anchoring catheter distal portion exit the working catheter lumen via the working catheter lumen distal aperture, respectively,

• a working catheter distal portion configured for passing through the working lumen distal aperture and through the widened passage, and comprising: o the working catheter lumen distal aperture, o preferably a working catheter radio-opaque material part configured for monitoring a position of the working catheter distal portion in the patient body, the working catheter being configured for running through the working lumen of the stabilizing catheter.

[0023] In a preferred embodiment of the kit of parts according to the invention:

• the working lumen of the stabilizing catheter extends along a working lumen axis between a working lumen proximal aperture and the working lumen distal aperture,

• at a level of the working lumen distal aperture along the stabilizing catheter longitudinal axis, an angle between a direction of the working lumen axis and a direction of the stabilizing catheter longitudinal axis is comprised between 30° and 135°, preferably between 45° and 120°, preferably between 60° and 90°,

• the working lumen distal aperture is preferably comprised in a lateral external surface of the stabilizing catheter distal portion.

[0024] In a preferred embodiment of the kit of parts according to the invention, the stabilizing catheter comprises:

• a fluid communication lumen configured for transferring an inflation fluid, preferably an inflation liquid, preferably a contrast agent, between the stabilizing catheter proximal portion and,

• a balloon attached to the stabilizing catheter distal portion and configured for, when positioned in the coronary sinus at a level of the passage, expanding upon being inflated by the inflation fluid up to contacting an internal surface of the coronary sinus, the balloon preferably expanding in a direction opposed to the working lumen distal aperture with respect to the stabilizing catheter longitudinal axis.

[0025] In a preferred embodiment of the kit of parts according to the invention, the anchoring catheter comprises one suture lumen, or a plurality of suture lumens each comprising a respective suture lumen distal aperture comprised in the anchoring catheter distal portion and configured for running the thread.

[0026] In a preferred embodiment of the invention, the kit of parts comprises a plurality of threads each configured for running through one or more of the suture lumens, and each comprising one or more of the anchoring elements coupled thereto and configured for fastening to the one or more anchoring sites in the vicinity of the mitral valve anterior annulus.

[0027] In a third aspect, the invention relates to a method for annuloplasty of a mitral valve in a patient body by using the kit of parts according to the invention, the method comprising the steps of: a) inserting an anchoring catheter into the patient body up to an anchoring catheter distal portion penetrates from a coronary sinus into a left atrium through a passage in a left atrium wall separating the left atrium from the coronary sinus, b) directing the anchoring catheter distal portion towards an anchoring site in a vicinity of a mitral valve anterior annulus, and running a thread through a suture lumen of the anchoring catheter and extending up to an anchoring catheter proximal portion located out of the patient body up to an anchoring element coupled to the thread projects out of the anchoring catheter distal portion, c) fastening the anchoring element to the anchoring site, and removing the anchoring catheter from the patient body, d) after step c), threading an implant over the thread up to positioning the implant substantially entirely in the coronary sinus and the passage, e) adjusting a distance separating the anchoring site from a portion of the left atrium wall adjacent to the passage by adjusting a position of the implant substantially entirely located in the coronary sinus and the passage along the thread passing through the passage, and setting a locking mechanism of the implant into a holding position wherein the locking mechanism is configured for preventing the implant to thread over the thread in at least a direction opposed to the direction of threading of the implant along the thread when inserting the implant in the patient body.

[0028] In a preferred embodiment of the invention, the method comprises the steps of: f) inserting a first guidewire in the patient body up to positioning a first guidewire distal end in a coronary sinus of the patient body, g) threading a stabilizing catheter over the first guidewire up to positioning a stabilizing catheter distal portion in the coronary sinus at a level of the left atrium wall, the first guidewire preferably passing through a guiding lumen of the stabilizing catheter, h) monitoring a position of, and directing a working lumen distal aperture of a working lumen of the stabilizing catheter towards the left atrium wall, i) running a dilator through the working lumen of the stabilizing catheter up to a dilator distal tip exits the working lumen distal aperture at a level of a left atrium wall puncturing site, j) running a needle through a dilator lumen of the dilator up to a needle tip exits a dilator lumen distal aperture comprised in the dilator distal tip, k) piercing, and creating a passage through the left atrium wall at the left atrium wall puncturing site with the needle tip, l) inserting the dilator distal tip through the passage for widening the passage, m) running a chosen one of the first guidewire or a second guidewire through the needle up to the first guidewire distal end or a second guidewire distal end, respectively, exits from the needle via the needle tip and penetrates into the left atrium, n) removing the dilator and the needle from the patient body while keeping the chosen one of the first guidewire distal end or the second guidewire distal end in the left atrium.

[0029] In a preferred embodiment of the invention, the method comprises the steps of: o) threading the anchoring catheter over the first guidewire or the second guidewire and through the working lumen of the stabilizing catheter up to the anchoring catheter distal portion exits the working lumen via the working lumen distal aperture, p) running the thread with the anchoring element coupled thereto through the suture lumen of the anchoring catheter up to the anchoring element exits from the suture lumen by a suture lumen distal aperture comprised in the anchoring catheter distal portion, q) monitoring a position of, and directing the suture lumen distal aperture towards an anchoring site in a vicinity of a mitral valve anterior annulus, r) threading an implant over the first or second guidewire and over the thread up to positioning the implant in the coronary sinus at the level of the passage and closing the passage by contacting a portion of the coronary sinus in a vicinity of the passage. [0030] In a preferred embodiment of the invention, the method comprises the steps of: s) running a working catheter through the working lumen of the stabilizing catheter up to a working catheter distal portion exits the working lumen distal aperture, t) running the dilator through a working catheter lumen up to the dilator distal tip exits the working catheter lumen via a working catheter lumen distal aperture, u) running the working catheter through the working lumen of the stabilizing catheter up to the working catheter distal portion penetrates into the left atrium via the passage, v) running the anchoring catheter through the working catheter lumen up to an anchoring catheter distal portion exits the working catheter lumen distal aperture into the left atrium, w) removing the working catheter from the patient body.

[0031] In a preferred embodiment of the invention, the method comprises the step of: x) inflating a balloon attached to the stabilizing catheter distal portion by injecting or pumping an inflation fluid, preferably an inflation liquid, preferably a contrast agent, in the balloon via a fluid communication lumen of the stabilizing catheter, up to contacting an internal surface of the coronary sinus with the balloon.

[0032] In a preferred embodiment of the invention wherein a set of anchoring elements (171 ) comprises a plurality of anchoring elements (171 a, 171 b) each coupled to the thread (170), the method comprises the step of fastening each anchoring element (171 a, 171 b) in the set of anchoring elements (171 ) to the anchoring site (334).

Short description of the drawings

[0033] These and further aspects of the invention will be explained in greater detail by way of example and with reference to the accompanying drawings in which: Fig.1 represents schematically a view from above of a left atrium and a coronary sinus separated by a left atrium wall comprising a passage.

Fig.2 and 2b represents example of the anchoring catheter according to the invention comprising one or two suture lumens, respectively.

Fig.3a represents an example of apparatus for annuloplasty according to the invention, comprising a single thread and a single anchoring element.

Fig.3b represents an example of apparatus for annuloplasty comprising three threads each coupled to a single anchoring element.

Fig.3c represents an example of apparatus for annuloplasty comprising three threads each coupled to a set (here, a pair) of anchoring elements.

Fig.3d represents an example of apparatus for annuloplasty comprising a single thread coupled to three anchoring elements fastened in separate anchoring sites. Fig.3e represents an example of apparatus for annuloplasty wherein both ends of the single thread are attached to the implant and wherein the anchoring element may slide along the thread.

Fig.3f represents an example of apparatus for annuloplasty wherein a first end of the single thread is attached to the implant and the second end of the single thread is attached to the anchoring element.

Fig.4a represents a view of the mitral valve and coronary sinus during a step of a method according to the invention wherein the first guidewire is inserted in the coronary sinus.

Fig.4b represents a view of the mitral valve and coronary sinus during a step of the method wherein the stabilizing catheter is thread over the first guidewire up to the coronary sinus.

Fig.4c represents a view of the mitral valve and coronary sinus during a step of the method wherein the working lumen distal aperture is oriented towards the left atrium wall.

Fig.4d represents a view of the mitral valve and coronary sinus during a step of the method wherein the dilator and the needle penetrate into the left atrium via the passage.

Fig.4e represents a view of the mitral valve and coronary sinus during a step of the method wherein the second guidewire distal end is left in the left atrium.

Fig.4f represents a view of the mitral valve and coronary sinus during a step of the method wherein the anchoring catheter distal portion penetrates into the left atrium.

Fig.4g represents a view of the mitral valve and coronary sinus during a step of the method wherein the anchoring catheter distal portion is oriented towards the anchoring site in the left atrium.

Fig.4h represents a view of the mitral valve and coronary sinus during a step of the method wherein the anchoring element is fastened in the vicinity of the mitral valve anterior annulus.

Fig.4i represents a view of the mitral valve and coronary sinus during a step of the method wherein the implant is positioned in the coronary sinus.

Fig.5a represents a view of the mitral valve and coronary sinus during a step of the method wherein the dilator and the needle are inserted up to the left atrium by passing in the working catheter. Fig.5b represents a view of the mitral valve and coronary sinus during a step of the method wherein the anchoring catheter is inserted up to the left atrium by passing in the working catheter.

Fig.6a represents a longitudinal cross section of the stabilizing catheter.

Fig.6b represents a perspective view of the stabilizing catheter.

Fig.6c represents an enlarged view of a longitudinal cross section of the stabilizing catheter distal portion.

Fig.7 represent an arrangement of the first guidewire, the needle, the dilator and the stabilizing catheter.

Fig.8a and 8b represent a longitudinal cross section of the implant wherein the locking mechanism is in the release position and in the holding position, respectively.

[0034] The drawings of the figures are neither drawn to scale nor proportioned. Generally, identical components are denoted by the same reference numerals in the figures.

Detailed description of embodiments of the invention

Kit of parts - anchoring catheter

[0035] Fig.1 is a schematic view from above of a mitral valve (300) in a patient body. In a first aspect, the invention relates to a kit of parts for annuloplasty of a mitral valve (300) in a patient body by a practician, wherein annuloplasty is a procedure to tighten, reshape, or reinforce the ring or annulus of the mitral valve (300) and tissues adjacent thereto in a patient heart. This ring or annulus is usually referred to as the mitral annulus which defines a mitral annular plane comprising the mitral annulus. The mitral annulus is located between a left ventricle and a left atrium (330) of the patient body and is an insertion site for the leaflet tissue. As represented in Fig. 1 , the mitral annulus comprises a mitral valve posterior annulus (337) and a mitral valve anterior annulus (335) i.e. , a posterior and an anterior part of the mitral annulus, respectively. The mitral valve posterior annulus (337) is adjacent and attached to a left atrium wall (331 ), and the left atrium wall (331 ) is a patient body tissue separating the left atrium (330) from the coronary sinus (320). The mitral valve anterior annulus (335) is located opposite to the mitral valve posterior annulus (337) in the left atrium (330).

[0036] As shown in Fig. 2a and 2b, the kit of parts according to the invention comprises an anchoring catheter (160) extending between an anchoring catheter proximal portion and an anchoring catheter distal portion (160d). The anchoring catheter proximal portion preferably comprises an anchoring catheter handle or grip coupled thereto for handling the anchoring catheter (160) by the practician and configured for remaining out of the patient body during an entire duration of an annuloplasty surgical procedure. The anchoring catheter distal portion (160d) is configured for inserting into a patient body up to the anchoring catheter distal portion (160d) penetrates from a coronary sinus (320) into a left atrium (330) through a passage (333; visible in Fig. 1 ) in the left atrium wall (331 ). Preferably, a transcatheter entry point i.e. , a point of entry of the anchoring catheter (160) in the patient body is at a level of a jugular vein of the patient body, and the anchoring catheter distal portion (160d) is configured for entering a blood circulatory system at the level of the jugular vein, and for reaching the coronary sinus (320) via a superior vena cava.

[0037] In the invention, the passage (333) between the coronary sinus (320) and the left atrium (330) can be at any location along the coronary sinus (320) as far as it is comprised in the left atrium wall (331 ) separating the left atrium (330) from the coronary sinus (320), so that the practician can choose the most suitable location depending on a desired change in the mitral valve shape. Preferably, the passage (333) through the left atrium wall (331 ) is at a level of a mitral valve posterior annulus (337), preferably in the P2 area. Preferably, an opening of the passage (333) on a side of the left atrium wall (331 ) oriented towards the left atrium (330) is at a distance from the coronary sinus (320) which is smaller than 10 mm, preferably smaller than 5 mm.

[0038] As represented in Fig. 2a and 2b, the anchoring catheter (160) comprises a suture lumen (161 ) comprising a suture lumen distal aperture (161 d) comprised in the anchoring catheter distal portion (160d). The suture lumen (161 ) preferably extends along the anchoring catheter (160) between the anchoring catheter proximal portion and the anchoring catheter distal portion (160d). The suture lumen (161 ) is configured for passing one or more threads (170). The suture lumen (161 ) may comprise a suture lumen proximal aperture comprised in the anchoring catheter proximal portion, such that the one or more threads (170) passing through the suture lumen (161 ) can exit via the suture lumen proximal aperture and be accessible to the practician.

[0039] For example, the suture lumen (161 ) may be configured for passing a single thread (170) as illustrated in Fig. 2a, wherein only one end of the thread may be accessible to the practician at a level of the anchoring catheter proximal portion. For example, the suture lumen (161 ) may be configured for passing a single thread (170) multiple times, preferably two times i.e., back and forth, such that both ends of the thread are accessible to the practician at the level of the anchoring catheter proximal portion. For example, the suture lumen (161 ) may be configured for passing a plurality of the threads (170-1 , 170-2, 170-3).

[0040] The anchoring catheter (160) may comprise one or more of the suture lumen (161 ), each comprising a respective suture lumen distal aperture (161 d) comprised in the anchoring catheter distal portion (160d), and each configured for passing one or more of the threads (170-1 , 170-2, 170-3). For example, as illustrated in Fig. 2b, the anchoring catheter (160) may comprise two suture lumens (161 ) configured for passing a single thread (170). In this case, both ends of the single thread (170) may be accessible to the practician at a level of the anchoring catheter proximal portion. For example, the anchoring catheter (160) may comprise a plurality of the suture lumen (161 ) illustrated in Fig. 2a, each configured for passing a single thread (170).

[0041] The anchoring catheter (160) may comprise means for orienting and/or guiding the anchoring catheter distal portion (160d) in the patient body up to the left atrium (330). For example, the anchoring catheter (160) may be a deflectable or steerable catheter. For example, a first guidewire (110) and/or a second guidewire (150) may be used for guiding catheters or other parts in the patient body by threading along them. In this case, the anchoring catheter (160) may for example comprise an anchoring catheter guiding lumen (164) as illustrated in Fig. 2a and 2b, which is configured for threading the anchoring catheter (160) along the first and/or the second guidewire (110, 150).

[0042] For example, the anchoring catheter distal portion (160d) may comprise an anchoring catheter radio-opaque material part (163) configured for monitoring a position of the anchoring catheter distal portion (160d) with medical imaging techniques.

Kit of parts - thread

[0043] The kit of parts according to the invention also comprises a thread (170) configured for running through the suture lumen (161 ) of the anchoring catheter (160). The thread (170) may comprise one or more anchoring elements (171 a, 171 b) coupled thereto. Each of the one or more anchoring elements (171 a, 171 b) may be configured for sliding along the thread (170), or for not sliding in at least one direction along the thread (170), or for not sliding in both directions along the thread (170) i.e., be attached to the thread (170). The thread (170) can be a wire, cord, or suture thread. The thread (170) can be made of polymer material, metal. Preferably, the anchoring catheter distal portion (160d) may be configured for coupling to the one or more anchoring elements (171 a, 171 b), and preferably for transmitting a torque to and for screwing one or more anchoring elements (171 a, 171 b) in the anchoring site (334).

[0044] For example, the kit of parts according to the invention may comprise a plurality of threads (170, 170-1 , 170-2, 170-3) each configured for running through one or more of the suture lumens (161 ), and each comprising one or more of the anchoring elements (171 a, 171 b, 172a, 172b) coupled thereto and configured for fastening to one or more anchoring sites (334, 334-1 , 334-2, 334-3) in the vicinity of the mitral valve anterior annulus (335).

[0045] Figures 3a to 3f represent various embodiments of threads (170, 170-1 , 170- 2, 170-3) and anchoring elements (171a, 171 b, 172a, 172b) couplings. In Fig. 3a, an example of thread (170) according to the invention comprises one anchoring element (171 a) attached to one end of the thread (170). In Fig. 3b, an example of three threads (170-1 , 170-2, 170-3) each having a single respective anchoring element (171 a, 172a, 173a) attached to its respective end is represented. In Fig. 3c, an example of three threads (170-1 , 170-2, 170-3) each having a respective set of anchoring elements (171a, 171 b), (172a, 172b), (173a) attached to its respective end is represented. In Fig. 3d, an example of a single thread (170) with three anchoring elements (171 a, 172a, 173a) coupled thereto is represented, wherein the anchoring elements (171 a, 172a, 173a) may slide along the thread (170). In Fig. 3e, an example of a single thread (170) with a single anchoring element (171 a) coupled thereto is represented, wherein the anchoring element (171 a) may slide along the thread (170). [0046] The one or more anchoring elements (171 a, 171 b, 172a, 172b) coupled to the thread (170) according to the invention are configured for fastening to one or more anchoring sites (334) in a vicinity of a mitral valve anterior annulus (335), which means in an internal surface of the left atrium (330) at a distance lower than 10 mm, preferably smaller than 5 mm from the mitral valve anterior annulus (335). They may have a shape of an arrowhead, a screw, or a hook. They are configured for anchoring in the vicinity of the mitral valve anterior annulus (335) and/or nearby tissues such as a left or right fibrous trigon.

[0047] In the invention, the use of anchoring elements prevents the need of suturing the mitral annulus. The anchoring elements may be fastened to the vicinity of the mitral valve anterior annulus (335) in different ways. For example, they may be projecting out and coupled to the anchoring catheter distal portion (160d). In this case, they may be fastened by pushing the anchoring catheter distal portion (160d) against the anchoring site (334), or they may be screwed in the anchoring site (334) by rotating the anchoring catheter distal portion (160d) and thus the anchoring element coupled thereto around the anchoring catheter longitudinal axis. For example, an anchoring element (171 a) may be attached to the thread (170) and remain in the suture lumen (161 ) up to contacting the anchoring site (334) with the anchoring catheter distal portion (160d), and then the thread (170) may be run in the suture lumen (161 ) up to the anchoring element (171 a) exits the suture lumen (161 ) and penetrates into the anchoring site (334).

Kit of parts - implant

[0048] As depicted on Figs. 3a to 3f, the kit of parts according to the invention may comprise an implant (180) as represented in Fig. 8a and 8b. The implant (180) comprises an implant thread lumen (182) configured for passing the thread (170) i.e. , for threading the implant over the thread (170). Preferably, the thread lumen (182) is configured for passing a plurality of threads (170, 170-1 , 170-2, 170-3). The implant (180) comprises a locking mechanism (183) movable from at least a release position to a holding position wherein the locking mechanism (183) is configured for allowing or preventing the implant (180) to thread over the one or more thread (170) in at least one direction, respectively. For example, the locking mechanism (183) can be a jaw mechanism, or a clamp. In Fig. 8a, the locking mechanism (183) is in the release position and the implant (180) may thread over the threads (170, 170-1 , 170-2, 170- 3) at least in an insertion direction of the implant (180) in the patient body along the threads (170). In Fig. 8b, the locking mechanism (183) is in a holding position and the implant (180) cannot thread over the threads (170, 170-1 , 170-2, 170-3) in a direction opposed to the insertion direction of the implant (180) in the patient body along the threads (170).

[0049] The implant (180) of the kit of parts according to the invention is configured for positioning almost or substantially entirely in the coronary sinus (320) and the passage (333) i.e., in a space or cavity or volume formed by the coronary sinus (320) and the passage (333) combined. In the present context, positioning the implant (180) almost or substantially entirely in the coronary sinus (320) and the passage (333) means that a main part of the implant (180) is configured for positioning in the coronary sinus (320), and that a minor part of the implant (180) is configured for positioning in the passage (333) and exceeding in the left atrium (330) by a distance from, and measured normal to, the side of the left atrium wall (331 ) oriented towards the left atrium (330) which is less than 4 mm, preferably less than 2 mm, preferably close to 0 mm. The implant (180) is preferably configured for positioning entirely in the coronary sinus (320) and the passage (333). This means that the minor part is preferably configured for not extending in the left atrium (330). The implant (180) may comprise no minor part and be configured for positioning entirely in the coronary sinus (320).

[0050] The implant thread lumen (182) may extend along an implant thread lumen axis between a proximal and a distal aperture of the implant thread lumen (182) located upstream and downstream along an insertion direction of the implant (180) in the patient body, respectively. The implant thread lumen (182) preferably extends through the minor part of the implant (180). The minor part of the implant (180) is preferably configured for avoiding a contact between the passage (333) and the one or more threads (170) passing through the implant thread lumen (182). The implant thread lumen (182) at a level of the minor part may have a diameter measured orthogonal to the implant thread lumen axis comprised between 0.1 and 1.8 mm, preferably between 0.3 and 1.2 mm. An external diameter of the minor part of the implant (180) measured orthogonal to the implant thread lumen axis is comprised between 0.3 and 2 mm, preferably comprised between 0.5 and 1 .5 mm.

[0051] The implant (180) is preferably configured for not requiring to position a first half portion of the implant (180) in the left atrium (330) and to position a second half portion of the implant (180) in the coronary sinus (320) when permanently installed in the patient body as in the prior art.

[0052] Preferably, the main part of the implant (180) is configured for not passing through a passage (333) having a maximum diameter of 4 mm and for letting an amount of blood flow through the coronary sinus (320) sufficient for not affecting a physical condition of the patient when positioned in the coronary sinus (320). Preferably, a length of the implant (180) measured along a longitudinal direction of the implant parallel to an insertion direction of the implant (180) in the coronary sinus (320) is greater than 10 mm, preferably comprised between 20 mm and 80 mm, and a thickness of the implant (180) measured along a lateral direction of the implant (180) orthogonal to the longitudinal direction of the implant (180) is lower than 5 mm, preferably comprised between 2 mm and 5 mm. [0053] The implant (180) of the kit of parts according to the invention is configured for contacting a portion of the coronary sinus in a vicinity of the passage (333) to close the passage (333), and for adjusting a distance separating the anchoring site (334) from a portion of the left atrium wall (331 ) in a vicinity of the passage (333) by adjusting a position of the implant (180) along the thread (170) passing through the passage (333).

[0054] Preferably, the implant (180) of the kit of parts according to the invention comprises an implant guiding lumen (181 ) as illustrated in Fig. 8a and 8b. The implant guiding lumen (181 ) is configured for passing a chosen one of the first guidewire (110) and/or second guidewire (150), and the implant (180) is configured for threading over the chosen one of the first guidewire (110) and/or second guidewire (150), and over the thread (170), up to the coronary sinus (320) at a level of the passage (333). In another example of the implant (180), the implant (180) is configured for threading over the chosen one of the first guidewire (110) and/or second guidewire (150), and over the thread (170), both passing through the implant thread lumen (182), and up to the coronary sinus (320) at a level of the passage (333).

[0055] Preferably, a portion of an external surface of the implant adjacent to a distal aperture of the implant thread lumen (182) is configured for adapting to an internal surface of the passage (333), and/or to an internal surface (320s) of the coronary sinus (320) adjacent to the passage (333), and for closing the passage (333) by contacting the internal surface of the passage (333), and/or the internal surface (320s) of the coronary sinus (320) adjacent to the passage (333), and for thereby preventing blood from circulating between the left atrium (330) and the coronary sinus (320).

[0056] The implant thread lumen (182) may comprise a proximal and a distal aperture of the implant thread lumen (182) located upstream and downstream along an insertion direction of the implant (180) in the patient body. Preferably, the implant (180) comprises an implant blade configured for cutting the one or more threads (170, 170-1 , 170-2, 170-3) at a level comprised between the locking mechanism (183) and the proximal aperture of the implant thread lumen (182). The implant blade may be part of the locking mechanism (183) or part of a separate implant cutting mechanism comprised in the implant (183).

Kit of parts - stabilizing catheter [0057] The kit of parts according to the invention preferably comprises a stabilizing catheter (120). As illustrated in Fig. 6a and Fig. 6b, the stabilizing catheter (120) extends along a stabilizing catheter longitudinal axis (120a) between a stabilizing catheter proximal portion (120p) and a stabilizing catheter distal portion (120d). A length of the stabilizing catheter (120) measured along the stabilizing catheter longitudinal axis (120a) is preferably larger than a distance separating the coronary sinus (320) from the transcatheter entry point in the patient body, such that the stabilizing catheter proximal portion (120p) remains outside of the patient body during the annuloplasty surgery and is accessible to the practician for manipulating the stabilizing catheter (120). The stabilizing catheter (120) preferably comprises a stabilizing catheter handle (121 ) coupled to the stabilizing catheter proximal portion (120p) which is for example configured for manipulating by the practician. The stabilizing catheter (120) preferably comprises a guiding lumen (122) configured for threading the stabilizing catheter (120) over a first guidewire (110) which is previously positioned in the patient body. The stabilizing catheter (120) comprises a working lumen (123) having a working lumen distal aperture (123d) comprised in the stabilizing catheter distal portion (120d). The stabilizing catheter (120) is configured for threading over the first guidewire (110) and in the patient body up to positioning the stabilizing catheter distal portion (120d) in the coronary sinus (320) at the level of the passage (333). The working lumen (123) of the stabilizing catheter (120) is configured for passing or running other catheters, for example the anchoring catheter (160) or a working catheter (200). For example, the anchoring catheter (160) may be configured for running in the working lumen (123) and the anchoring catheter distal portion (160d) is configured for passing through the working lumen distal aperture (123d) towards the passage (333).

[0058] In another example of the kit of part according to the invention, the stabilizing catheter (120) may be configured for threading over the first guidewire (110) passing through the working lumen (123), and preferably comprises no guiding lumen (122). In this case, the stabilizing catheter (120) may be guided in the patient body by following the first guidewire (110) previously positioned therein.

[0059] As represented in Fig. 6c, the working lumen (123) of the stabilizing catheter (120) of the kit of parts according to the invention preferably extends along a working lumen axis (123a) between a working lumen proximal aperture and the working lumen distal aperture (123d), wherein the working lumen proximal aperture is preferably comprised in a stabilizing catheter proximal portion (120p), and preferably accessible to the practician during the annuloplasty surgery. Preferably, at a level of the working lumen distal aperture (123d) along the stabilizing catheter longitudinal axis (120a), an angle a between a direction of the working lumen axis (123a) and a direction of the stabilizing catheter longitudinal axis (120a) is comprised between 30° and 135°, preferably between 45° and 120°, preferably between 60° and 90°. In the case a=0°, the working lumen axis (123a) is parallel to the stabilizing catheter longitudinal axis (120a) at the level of the working lumen distal aperture (123d), and an anchoring catheter distal portion (160d) running through the working lumen (123) will exit through the working lumen distal aperture (123d) in a direction parallel to the insertion direction of the working catheter distal portion (160d) in the coronary sinus (320).

[0060] Preferably, the working lumen distal aperture (123d) is comprised in a lateral external surface (120s) of the stabilizing catheter distal portion (120d), wherein a normal of the lateral external surface (120s) of the stabilizing catheter distal portion (120d) is preferably substantially orthogonal to the stabilizing catheter longitudinal axis (120a). In the example of Fig. 6c, the angle a is substantially equal to 90°.

[0061] As represented in Fig. 4c, the stabilizing catheter (120) preferably is a balloon catheter and comprises a fluid communication lumen (126) configured for transferring an inflation fluid, preferably an inflation liquid, preferably comprising a contrast agent, between the stabilizing catheter proximal portion (120p) and a balloon (125) attached to the stabilizing catheter distal portion (120d). The balloon (125) is configured for, when positioned in the coronary sinus (320) at a level of a left atrium wall puncturing site (332) which is a future location of the passage (333), expanding upon being inflated by the inflation fluid up to contacting an internal surface (320s) of the coronary sinus (320). Preferably, the balloon (125) of the stabilizing catheter (120) is configured for expanding in a direction opposed to the working lumen distal aperture (123d) with respect to the stabilizing catheter longitudinal axis (120a). Preferably, the balloon (125) of the stabilizing catheter (120) is configured for expanding up to contacting an internal surface (320s) of the coronary sinus (320) and applying a pressure force on the internal surface (320s) which balances a puncturing force for piercing the left atrium wall (331 ) with the needle (130) and/or a penetration force for widening the passage (333) by the dilator (140). [0062] Alternatively, the stabilizing catheter distal portion (120d) may comprise a nitinol structure or stent instead of the balloon (125), wherein the nitinol structure or stent is configured for contacting the internal surface (320s) of the coronary sinus (320) when deployed in the coronary sinus (320) for maintaining a chosen position of the stabilizing catheter distal portion (120d) in the coronary sinus (320).

[0063] Preferably, the stabilizing catheter (120) comprises a stabilizing catheter radio-opaque material part (124) attached to the stabilizing catheter distal portion (120d) and configured for monitoring a position of the stabilizing catheter distal portion (120d) in the patient body using medical imaging methods. Preferably, a portion of the stabilizing catheter radio-opaque material part (124) has no continuous rotational symmetry around the stabilizing catheter longitudinal axis (120a) and is configured for monitoring an angular position of the stabilizing catheter distal portion (120d) around the stabilizing catheter longitudinal axis (120a). Preferably, the portion of the stabilizing catheter radio-opaque material part (124) is located in a vicinity of the working lumen distal aperture (123d).

Kit of parts - needle

[0064] As represented in Fig. 7, the kit of parts according to the invention preferably comprises a needle (130) comprising a needle tip (130d). The needle (130) is configured for piercing the left atrium wall (331 ) at a left atrium puncturing site (332) with the needle tip (130d), and for creating the passage (333) through the left atrium wall (331 ). This allows traversing the left atrium wall (331 ) and entering the left atrium (330) from the coronary sinus (320) with other tools or catheters. Preferably, the needle (130) is a hollow needle configured for running the first guidewire (110) or a second guidewire (150) through the needle (130) and the needle tip (130d). The needle (130) may be retractable in the dilator (140).

Kit of parts - dilator

[0065] As represented in Fig. 5a, the kit of parts according to the invention preferably comprises a dilator (140). The dilator (140) is configured for increasing a size or diameter of the passage (333) such that catheters larger than the needle (130) may pass through the passage (333), for example. Preferably, the dilator is configured for enlarging the passage (333) up to the passage (333) is suitable for passing a catheter with a circular cross section of a diameter comprised between 3 and 5 mm, preferably 4 mm therethrough. The dilator (140) is preferably configured for running through the working lumen (123) of the stabilizing catheter (120). It comprises a dilator lumen (141 ) comprising a dilator lumen distal aperture (141 d) and configured for running the needle (130) through the dilator lumen distal aperture (1 1 d) between a retracted and a deployed position wherein the needle tip (130d) is in and out of the dilator lumen (141 ), respectively. The dilator (140) comprises a dilator distal tip (140t) comprising the dilator lumen distal aperture (141 d) and configured for passing through the working lumen distal aperture (123d) and through the passage (333), and for widening the passage (333) previously pierced by the needle (130). As shown in Fig. 7, the dilator distal tip (140t) may have a conical shape.

[0066] Preferably, the dilator (140) comprises a dilator distal portion adjacent to the dilator distal tip (140t), and a dilator radio-opaque material part (142) attached to the dilator distal portion and configured for monitoring a position of the dilator distal portion with medical imaging means.

Kit of parts - implant catheter

[0067] As represented in Fig. 4i, the kit of parts (110) according to the invention preferably comprises an implant catheter (190) configured for threading over at least one of the first guidewire and/or the second guidewire (150), and for pushing the implant (180) along the first guidewire (110) and/or the second guidewire (150) up to positioning the implant (180) in the coronary sinus (320). The implant catheter (190) comprises an implant catheter lumen (191 ) configured for passing the first guidewire (110) and/or the second guidewire (150). Preferably, the implant catheter (190) is also configured for threading over the one or more thread (170), wherein the one or more thread (170) either passes in the implant catheter lumen (191 ) or in a separate lumen of the implant catheter (190).

[0068] In an example of the implant catheter (190) according to the invention, the implant catheter (190) comprises an implant catheter blade configured for cutting the one or more thread (170) passing through it.

[0069] Preferably, the implant catheter (190) extends between a proximal end of the implant catheter which is coupled to an implant catheter handle and a distal end of the implant catheter which is configured for pushing the implant (180) along the first guidewire (110) and/or the second guidewire (150) up to positioning the implant (180) in the coronary sinus (320), preferably by coupling the distal end of the implant catheter (190) with the implant (180). Preferably, the implant catheter (190) is configured for changing a position of the locking mechanism (183) and/or for changing a position of the cutting mechanism of the implant (180) coupled to the distal end of the implant catheter (190) by modifying a position of the implant catheter handle relative to the implant catheter (190).

Kit of parts - working catheter

[0070] The kit of parts according to the invention may further comprise a working catheter (200) configured for running through the working lumen (123) of the stabilizing catheter (120). As represented in Fig. 5a and 5b, the working catheter (200) comprises a working catheter lumen (201 ) comprising a working catheter lumen distal aperture (201 d) and configured for alternatively passing the dilator (140) or the anchoring catheter (160) up to the dilator distal tip (140t) or the anchoring catheter distal portion (160d), respectively, exit the working catheter lumen (201 ) via the working catheter lumen distal aperture (201 d). As represented in Fig. 5b, the working catheter (200) comprises a working catheter distal portion (200d) configured for passing through the working lumen distal aperture (123d) and through the widened passage (333). The working catheter distal portion (200d) comprises the working catheter lumen distal aperture (201 d), and preferably a working catheter radioopaque material part (202) configured for monitoring a position of the working catheter distal portion (200d) in the patient body via medical imaging means. Once the working catheter distal portion (200d) is positioned in the left atrium (330) as shown in Fig. 5a and 5b, the working catheter (200) is configured for providing transcatheter access to the left atrium via the passage (333) by keeping the tissues forming the passage (333) apart.

[0071] The working catheter (200) may be a deflectable or steerable catheter, such that a position or a direction of the working catheter distal portion (200d) may be modified by the practician, while preferably remaining substantially comprised in the mitral annular plane. In this case, a position, or a direction of the anchoring catheter distal portion (160d) which is located in or projecting out of the working catheter distal portion (200d) may be modified by changing the position or direction of the working catheter distal portion (200d) holding it. Preferably, the working catheter proximal portion (200p) comprises a working catheter handle configured for holding by a practician and for driving a steering mechanism of the working catheter (200).

Method

[0072] In a second aspect, the invention relates to a method for annuloplasty of a mitral valve (300) in a patient body using the kit of parts according to the invention and comprising at least the anchoring catheter (160), the thread (170) with an anchoring element (171 a, 171 b, 172a, 172b, 173a) coupled thereto, and the implant (180). Fig.4a to 4i represent steps of an example of the method.

[0073] As represented in Fig. 4b, the method comprises a step a) of inserting the anchoring catheter (160) into the patient body up to the anchoring catheter distal portion (160d) penetrates from the coronary sinus (320) into the left atrium (330) through a passage (333) in the left atrium wall (331 ). For example, the transcatheter entry point may be at the level of the jugular vein of the patient, and the anchoring catheter distal portion (160d) penetrates into the blood circulatory system at the level of the jugular vein and is inserted up to the coronary sinus via the superior vena cava. Positioning the anchoring catheter distal portion (160d) may be achieved in different ways. For example, it may comprise directing or orienting the anchoring catheter distal portion (160d) in the blood circulatory system of the patient body if the anchoring catheter (160) is deflectable or steerable. For example, it may comprise threading the anchoring catheter (160) along a first guidewire (110) or a second guidewire (150) previously inserted in the patient body along an insertion path to be followed by the anchoring catheter distal portion (160d), wherein the insertion path preferably extends from the jugular vein up to the coronary sinus (320) at a level of the passage (333), and preferably up to the left atrium (330) via the passage (333) through the left atrium wall (331 ).

[0074] After inserting the anchoring catheter distal portion (160d) into the left atrium (300), the method comprises a step b) of directing the anchoring catheter distal portion (160d), and preferably an anchoring catheter distal tip comprised in the anchoring catheter distal portion (160d), towards an anchoring site (334) in the vicinity of the mitral valve anterior annulus (335). The step b) also comprises running the thread (170) through the suture lumen (161 ) of the anchoring catheter (160) up to an anchoring element (171a, 171 b, 172a, 172b, 173a) coupled to the thread (170) exits the suture lumen (161 ) by the suture lumen distal aperture (161 d) and/or projects out of the anchoring catheter distal portion (160d). During this step, the thread (170) extends up to an anchoring catheter proximal portion located out of the patient body, such that the practician has access to the thread (170). Running the thread (170) through the suture lumen (161 ) up to the anchoring element exits the suture lumen (161 ) can be performed before or after directing the anchoring catheter distal portion (160d) towards the anchoring site (334). After step b), the anchoring catheter distal portion (160d), and preferably the anchoring catheter distal tip, has at least one anchoring element (171 a, 171 b, 172a, 172b, 173a) coupled thereto and preferably projecting out thereof in a longitudinal direction of the anchoring catheter and towards the anchoring site (334). The at least one anchoring element (171 a, 171 b, 172a, 172b, 173a) is coupled to the thread (170) passing through the suture lumen (161 ) of the anchoring catheter (160), the suture lumen (161 ) and the thread (170) extending up to the anchoring catheter proximal portion located out of the patient body. The at least one anchoring element (171 a, 171 b, 172a, 172b, 173a) may be coupled to the anchoring catheter distal portion (160d) directly or via the thread (170) passing through the suture lumen (161 ).

[0075] The thread (170) may be preloaded or inserted in the suture lumen (161 ) before or after inserting the anchoring catheter distal portion (160d) in the patient body, respectively.

[0076] Once the anchoring catheter distal portion (160d) is directed towards the anchoring site (334), the method comprises a step c) of fastening the anchoring element (171 ) to the anchoring site (334). For example, the step c) may comprise inserting one or more anchoring elements (171 a, 171 b) having a shape of an arrowhead or a hook in the anchoring site (334). It may also comprise screwing one or more anchoring elements (171 a, 171 b) preferably having a shape of a screw in the anchoring site (334). The step c) also comprises removing the anchoring catheter (160) from the patient body after the fastening of the anchoring elements (171 a, 171 b). Following this, other parts may be thread over the thread (170), such as an implant (180) or an implant catheter (190).

[0077] After step c), the method comprises a step d) of threading the implant (180) over the thread (170) up to positioning the implant (180) substantially entirely in the coronary sinus (320) and the passage (333), see Fig. 4i. Preferably, the implant (180) is thread over the thread (170) up to contacting a portion of an internal surface (320s) of the coronary sinus (320) in a vicinity of the passage (333) i.e. , up to contacting a portion of the left atrium wall (331 ) which is adjacent to the passage (333) and oriented towards the coronary sinus (320). If the implant comprises the minor part of the implant, step d) may comprise positioning the minor part of the implant in the passage (333). During this step, remaining out of the left atrium (330) with the implant (180) allows to reduce the size or diameter of the passage (333) pierced through the left atrium wall (331 ) and thereby to reduce the invasiveness of the annuloplasty surgery. Reducing the size of the passage (333) also reduces a parasitic flow of blood passing through the passage (333) and circulating between the left atrium (330) and the coronary sinus (320).

[0078] Once the implant (180) is in the coronary sinus (320), the method comprises a step e) of adjusting a distance separating the anchoring site (334) from the portion of the left atrium wall (331 ) adjacent to the passage (333) by adjusting a position of the implant (180) almost entirely located in the coronary sinus (320) and the passage (333) along the thread (170) passing through the passage (333). As a consequence, a distance D separating the anchoring site (334) from the portion of the left atrium wall (331 ) adjacent to the passage (333) may be reduced or shortened, and the shape of the mitral annulus is altered. Once the distance D reaches a desired value by appropriately threading the implant (180) along the thread (170), the step e) of the method comprises setting the locking mechanism (183) of the implant (180) into a holding or locking position wherein the locking mechanism (183) is configured for preventing the implant (180) to thread over the thread (170) in at least a direction opposed to the direction of threading of the implant (180) along the thread (170) when inserting the implant (180) in the patient body. Preferably, the locking mechanism (183) of the implant (180) is configured for preventing the implant (180) to thread over the thread (170) such that the implant (180) is stationary relative to the thread (170). The implant (180) of the invention is configured for remaining in the coronary sinus and for not passing through the passage (333) when a traction force is applied on it by the thread (170) coupled thereto and to anchoring site (334) and passing through the passage (333).

Method - first guidewire

[0079] As represented in Fig. 4a, the method according to the invention preferably comprises a step f) before step a), of inserting a first guidewire (110) in the patient body up to positioning a first guidewire distal end (110d) in a coronary sinus (320) of the patient body, preferably at a level of the left atrium wall (331 ). This first guidewire (110) helps providing transcatheter access to the coronary sinus (320) by allowing to thread other catheters over the first guidewire (110) up to the coronary sinus (320). Preferably, the transcatheter entry point may be at the level of the jugular vein of the patient, and the first guidewire distal end (110d) penetrates into the blood circulatory system at the level of the jugular vein and is inserted up to the coronary sinus (320) via the superior vena cava.

Method - stabilizing catheter [0080] Preferably, the method comprises a step g), preferably between steps f) and a), of threading the stabilizing catheter (120) over the first guidewire (110) and into the patient body up to positioning the stabilizing catheter distal portion (120d) in the coronary sinus (320) at the level of the left atrium wall (331 ), as illustrated in Fig. 4b. In the step g), the first guidewire (110) previously inserted in the patient body guides the stabilizing catheter distal portion (120d) in the patient body by preferably passing through the guiding lumen (122) of the stabilizing catheter (120), as represented in Fig. 6b and 6c. Alternatively, the stabilizing catheter (120) may thread over the first guidewire (110) passing through the working lumen (123).

[0081] After performing step g), the stabilizing catheter (120) thus provides an access for other catheters such as the dilator (140) or the anchoring catheter (160) or the working catheter (200) to the coronary sinus (320), and guides the other catheters such as the dilator (140) or the anchoring catheter (160) or the working catheter (200) in the patient body. In other words, the other catheters such as the dilator (140) or the anchoring catheter (160) or the working catheter (200) may run through and follow the working lumen (123) in the patient body up to reaching the coronary sinus (320).

[0082] Preferably, the step g) may comprise a monitoring of a position of a stabilizing catheter radio-opaque material part (124) attached to the stabilizing catheter distal portion (120d), so that the practician may verify that the stabilizing catheter distal portion (120d) is positioned in the coronary sinus (320), for example via medical imaging means.

[0083] As illustrated in Fig. 4c, the method preferably comprises a step h), preferably between steps g) and a), of monitoring a position of, and directing the working lumen distal aperture (123d) of the working lumen (123) of the stabilizing catheter (120) towards the left atrium wall (331 ). For example, the monitoring of the position of the working lumen distal aperture (123d) may be achieved by monitoring the position of the stabilizing catheter radio-opaque material part (124) attached to the stabilizing catheter distal portion (120d). For example, in the case of a stabilizing catheter (120) wherein, at a level of the working lumen distal aperture (123d) along the stabilizing catheter longitudinal axis (120a), the direction of the working lumen axis (123a) and the direction of the stabilizing catheter longitudinal axis (120a) forms an angle comprised between 30° and 135°, preferably between 45° and 120°, preferably between 60° and 90°, the stabilizing catheter (120) may be rotated around the stabilizing catheter longitudinal axis (120a) by the practician preferably holding the stabilizing catheter handle (121 ) up to orienting the working lumen distal aperture (123d) towards the left atrium wall (331 ) such that another catheter or tool running through the working lumen (123) exits via the working lumen distal aperture (123d) towards the left atrium wall (331 ).

[0084] Step h) preferably comprises the step x) of inflating the balloon (125) attached to the stabilizing catheter distal portion (120d) by injecting or pumping the inflation fluid, preferably the inflation liquid, preferably the contrast agent, in the balloon (125) via the fluid communication lumen (126) of the stabilizing catheter (120), at least up to contacting an internal surface (320s) of the coronary sinus (320) with the balloon (125).

Method - dilator

[0085] Preferably, the method comprises a step i), preferably between steps h) and a), of running the dilator (140) through the working lumen (123) of the stabilizing catheter (120) up to a dilator distal tip (140t) exits the working lumen distal aperture (123d) at a level of a left atrium wall puncturing site (332) wherein a passage (333) shall be pierced. This does not restrict the scope of the invention to inserting the dilator (140) in the working lumen between steps h) and a), but only to run the dilator

(140) through the working lumen (123) for exiting the working lumen (123) via the working lumen distal aperture with the dilator distal tip (140t) between steps h) and a). The dilator (140) may be inserted in the working lumen (123) before or after inserting the stabilizing catheter (120) in the patient body i.e. , the dilator (140) may be preloaded in the stabilizing catheter (120) or not.

[0086] If the stabilizing catheter (120) is inserted in the patient body by threading over the first guidewire (110) passing through the working lumen (123) and not in the guiding lumen (122), the first guidewire (110) may pass through the dilator lumen

(141 ) of the dilator (140) before or after inserting the dilator (140) in the working lumen (123).

Method - needle

[0087] Preferably, the method comprises a step j), preferably between steps h) and a) or between steps i) and a), of running the needle (130) through the dilator lumen (141 ) of the dilator (140) up to the needle tip (130d) exits the dilator lumen distal aperture (141 d) comprised in the dilator distal tip (140t). This does not necessarily imply that the needle (130) is inserted in the dilator lumen (141 ) between steps i) and a), but it means that the needle tip (130d) exits the dilator lumen distal aperture ( 141 d) between steps i) and a). For example, the needle (130) may be inserted in the dilator lumen (141 ) before or after inserting the dilator (140) in the patient body via the working lumen (123). For example, the needle (130) may be inserted in the dilator lumen (141 ) before or after inserting the dilator (140) in the stabilizing catheter (120). [0088] The needle is preferably a hollow needle. If the stabilizing catheter (120) is inserted in the patient body by threading over the first guidewire (110) passing through the working lumen (123) and not in the guiding lumen (122), the first guidewire (110) may pass through the hollow needle (130) before or after inserting the hollow needle (130) in the dilator (140), and before or after inserting the dilator (140) in the working lumen (123).

[0089] After performing steps g) to j), the needle tip (130d) is in the coronary sinus (320) and pointing towards the left atrium wall (331 ). As illustrated in Fig. 4d, the method preferably comprises a step k), preferably between steps i) and a), preferably between steps j) and a), of piercing and creating a passage (333) through the left atrium wall (331 ) at the left atrium wall puncturing site (332) with the needle tip (130d). The force for piercing the left atrium wall (331 ) with the needle (130) may be achieved by running the needle tip (130d) further out of the dilator lumen (141 ), and/or by running the dilator distal tip (140t) with the needle (130) projecting out thereof further out of the working lumen (123).

[0090] As illustrated in Fig. 4d, the method preferably comprises a step I), preferably between steps k) and a), of inserting the dilator distal tip (140t) through the passage (333) for widening the passage (333). This means following the needle (150) in the passage (333) with the dilator distal tip (140t), for enlarging the passage (333). Preferably, the dilator is configured for enlarging the passage (333) up to the passage (333) is suitable for passing a catheter having a circular cross section with a diameter comprised between 3 and 5 mm, preferably 4 mm therethrough.

Method - guidewire in the left atrium

[0091] As illustrated in Fig. 4d, the method preferably comprises a step m), preferably between steps k) and a), of running a chosen one of the first guidewire (110) or the second guidewire (150) through the needle (130) being a hollow needle up to the first guidewire distal end (110d) or the second guidewire distal end (150d), respectively, exits from the needle (130) via the needle tip (130d) and penetrates into the left atrium (330). After creating the passage (333), the step m) of placing the chosen one of the first guidewire distal end or the second guidewire distal end in the left atrium (330) thus allows to thread other catheters such as the anchoring catheter along the chosen one of the first or second guidewire to easily access the left atrium and perform other operations. Preferably, the step m) is performed between steps k) and I).

[0092] As illustrated in Fig. 4e, the method preferably comprises a step n), preferably between steps m) and a), of removing the dilator (140) and the needle (130) from the patient body while keeping the chosen one of the first guidewire distal end (110d) or the second guidewire distal end (150d) in the left atrium (330).

[0093] As illustrated in Fig. 4f, the step a) of inserting an anchoring catheter (160) into the patient body in the method according to the invention preferably comprises a step o) of entering and inserting the anchoring catheter (160) in the patient body via the working lumen (123) of the stabilizing catheter (120) which thus guides the anchoring catheter (160) up to the anchoring catheter distal portion (160d) exits the working lumen (123) via the working lumen distal aperture (123d). While running through the working lumen (123) in step o), the anchoring catheter (160) may preferably thread over the chosen one of the first guidewire (110) or the second guidewire (150) having its distal end in the left atrium (330) up to the anchoring catheter distal portion (160d) exits the working lumen (123) via the working lumen distal aperture (123d).

[0094] As illustrated in Fig. 4g, the step b) of directing the anchoring catheter distal portion (160d) with an anchoring element (171 a, 171 b, 172a, 172b, 173a) coupled thereto and preferably projecting out thereof towards an anchoring site (334) in the method according to the invention preferably comprises a step p). The step p) comprises running the thread (170) with the anchoring element (171 a, 171 b, 172a, 172b) coupled thereto through the suture lumen (161 ) of the anchoring catheter (160) up to the anchoring element (171 a, 171 b, 172a, 172b) exits from the suture lumen (161 ) by a suture lumen distal aperture (161 d) comprised in the anchoring catheter distal portion (160d). The thread (170) may be inserted in the suture lumen (161 ) before or after the anchoring catheter (160) is inserted in the patient body, but the anchoring element (171a, 171 b, 172a, 172b) exits the suture lumen (161 ) during step P)-

[0095] As illustrated in Fig. 4g, the step b) may also comprise a step q) before and/or after step p), of monitoring a position of, and directing the suture lumen distal aperture (161 d) towards an anchoring site (334) in the vicinity of the mitral valve anterior annulus (335).

[0096] As illustrated in Fig. 4h, the method preferably comprises removing the anchoring catheter (160) and the stabilizing catheter (120) from the patient body before step d) which comprises threading an implant (180) over the thread (170) up to positioning a substantially entirety of the implant (180) in the coronary sinus (320) and the passage (333). When removing the anchoring catheter (160), the one or more threads (170, 170-1 , 170-2, 170-3) run in the suture lumen (161 ) and remain coupled to the one or more anchoring elements (171 a, 171 b, 172a, 172b).

[0097] Preferably, step d) comprises the step r) of threading an implant (180) over the first and/or the second guidewire (110, 150) in addition to the thread (170) up to positioning the implant (180) in the coronary sinus (320) at the level of the passage (333) and closing the passage (333). Preferably, the passage (333) may be closed by the implant (180) without requiring suturing the passage (333). For example, the implant (180) may be configured for contacting a portion of the internal surface (320s) of the coronary sinus (320) in a vicinity of the passage (333) for closing the passage (333).

Method - working catheter

[0098] In the method according to the invention, a working catheter (200) may also be used for guiding other catheters, for example, the dilator (140) and the anchoring catheter (160), in the patient body up to the left atrium (330), as illustrated in Fig. 5a and 5b.

[0099] As illustrated in Fig. 5a, the method preferably comprises a step s), preferably between steps h) and n), of running the working catheter (200) through the working lumen (123) of the stabilizing catheter (120) up to a working catheter distal portion (200d) exits the working lumen distal aperture (123d). Step s) does not necessarily comprises inserting the working catheter (200) in the stabilizing catheter (120), but at least exiting the working lumen distal aperture (123d) with the working catheter distal portion (200d). The working catheter (200) may be inserted in the working lumen (123) before or after inserting the stabilizing catheter (120) in the patient body. A position of the working catheter distal portion (200d) may be monitored using medical imaging techniques and/or method if the working catheter distal portion (200d) comprises a working catheter radio-opaque material part (202). [0100] The working catheter (200) comprises a working catheter lumen (201 ) extending between the working catheter distal portion (200d) and the working catheter proximal portion (200p), and the working catheter (200) is configured for inserting in the patient body while keeping the working catheter proximal portion (200p) accessible to the practician outside of the patient body. The dilator (140) may be inserted in the working catheter (200) before or after inserting the working catheter in the patient body, and before or after inserting the working catheter (200) in the stabilizing catheter (120). The needle (130) may be inserted in the dilator (140) before or after inserting the dilator (140) in the working catheter (200).

[0101] As illustrated in Fig. 5a, the method preferably comprises a step t), preferably between steps s) and I), of running the dilator (140) through the working catheter lumen (201 ) up to the dilator distal tip (140t) exits the working catheter lumen (201 ) via a working catheter lumen distal aperture (201 d).

[0102] As illustrated in Fig. 5a, the method preferably comprises a step u), preferably between steps I) and n), of running the working catheter (200) through the working lumen (123) of the stabilizing catheter (120) up to the working catheter distal portion (200d) penetrates into the left atrium (330) via the passage (333). Preferably, the working catheter distal portion (200d) enters the left atrium (330) immediately following the dilator distal tip (140t) to keep the tissues adjacent to the passage (333) apart and the passage (333) open.

[0103] As illustrated in Fig. 5b, step a) of the method preferably comprises a step v) of running the anchoring catheter (160) through the working catheter lumen (201 ) up to an anchoring catheter distal portion (160d) exits the working catheter lumen distal aperture (201 d) into the left atrium (330). Before this step v), the dilator (140) and the needle (130) are removed from the patient body while leaving the first or the second guidewire distal end (110d, 150d) in the left atrium (330) as well as the working catheter distal portion (200d) in the left atrium (330) too. The anchoring catheter (160) may pass through the working lumen (123) and reach the left atrium (330) by threading along the first guidewire (110) or the second guidewire (150), or just by passing inside the working catheter lumen (201 ).

[0104] The method preferably comprises a step w), preferably during the removal the anchoring catheter (160) from the patient body in step c) or preferably between steps c) and d), of removing the working catheter (200) from the patient body. The anchoring catheter distal portion (160d) is preferably retracted within the working catheter lumen (201 ) before exiting from the left atrium (330) with the working catheter (200) i.e., before removing the working catheter distal portion (200d) from the left atrium (330). The working catheter distal portion (200d) is preferably retracted in the working lumen (123) of the stabilizing catheter (120) before removing the stabilizing catheter distal portion (120d) from the coronary sinus (320).

[0105] If the anchoring catheter (160) is a steerable catheter, the directing of the anchoring catheter distal portion (160d) in step b) of the method may comprise positioning the anchoring catheter distal portion (160d) by displacing the anchoring catheter distal portion (160d) along a trajectory substantially comprised in a mitral annular plane of the patient body. If the working catheter (200) is a steerable catheter, the directing of the anchoring catheter distal portion (160d) in step b) of the method may comprise positioning the anchoring catheter distal portion (160d) projecting out of the working catheter distal portion (200d) by displacing the working catheter distal portion (200d) along a trajectory substantially comprised in a mitral annular plane of the patient body.

Method - cutting the thread

[0106] After step e) of the method comprising the setting of the locking mechanism (183) of the implant (180) into a holding or locking position, the method may comprise the step y) of cutting a proximal parts (174, 174-1 , 174-2, 174-3) of the one or more threads (170) located upstream of the implant (180) along an insertion direction of the implant (180) into the patient body, and removing the proximal parts (174, 174-1 , 174-2, 174-3) of the threads (170, 170-1 , 170-2, 170-3) from the patient body. Of course, the practician should also remove all the parts of the kit of parts remaining in the patient body, such as the first guidewire except the parts comprised in the implanted apparatus before ending the annuloplasty. These parts to be removed comprise the first guidewire (110), the second guidewire (150), the implant catheter (190). If a second guidewire is used, it may be removed from the left atrium (330) by the practician before the step of cutting the proximal parts.

Apparatus

[0107] In a third aspect, the invention relates to an apparatus for permanent annuloplasty of a mitral valve (300) in a patient body. The apparatus comprises one or more sets (171 , 172, 173) of anchoring elements (171 a, 171 b, 172a, 172b, 173a). Each of the sets (171 , 172, 173) of anchoring elements comprises one or more anchoring elements (171 a, 171 b, 172a, 172b, 173a) configured for fastening to one or more anchoring sites (334, 334-1 , 334-2, 334-3) in the vicinity of the mitral valve anterior annulus (335), wherein the anchoring elements comprised in a same set are configured for fastening to a same anchoring site. For example, the anchoring elements are configured for fastening to one or more anchoring sites (334) in the vicinity of the mitral valve anterior annulus (335) at a level of a left fibrous trigon, or a right fibrous trigon, or between the left and right fibrous trigon, or substantially equidistant from the left and right fibrous trigon.

[0108] The apparatus comprises one or more threads (170, 170-1 , 170-2, 170-3) traversing the passage (333) through the left atrium wall (331 ) separating the coronary sinus (320) from the left atrium (330), and coupled to the one or more anchoring elements (171 a, 171 b). All the anchoring elements (171a, 171 b, 172a, 172b, 173a) are coupled to one or more threads (170, 170-1 , 170-2, 170-3).

[0109] The apparatus comprises an implant (180) configured for being almost entirely positioned in the coronary sinus (320) and the passage (333), and attached to one or more threads (170, 170-1 , 170-2, 170-3) of the apparatus, preferably to all of the threads of the apparatus.

[0110] Examples of sets of anchoring elements are represented in Figs. 3a-3f. In Fig. 3a, the apparatus comprises a single thread (170) which is coupled and attached to a single set (171 ) comprising one anchoring element (171 a) fastened to one anchoring site (334-1 ). In Fig. 3b, the apparatus comprises three threads (170-1 , 170- 2, 170-3) each coupled and attached to a respective, single set (171 , 172, 173), each of the sets (171 , 172, 173) comprising a respective, single anchoring element (171 a, 172a, 173a) fastened to a respective anchoring site (334-1 , 334-2, 334-3). In Fig. 3c, the apparatus comprises three threads (170-1 , 170-2, 170-3) each coupled and attached to a respective, single set (171 , 172, 173), each of the sets (171 , 172, 173) comprising a respective set of anchoring elements (171 a, 171 b), (172a, 172b), (173a) coupled to a same, respective anchoring site (334-1 , 334-2, 334-3). For example, a first thread (170-1 ) is coupled to a first anchoring element (171 a) and to a second anchoring element (171 b) both comprised in a first set (171 ) of anchoring elements, and the first and second anchoring elements (171 a, 171 b) are coupled to a first anchoring site (334-1 ) in a vicinity of the left fibrous trigon. In Fig. 3d, the apparatus comprises a single thread (170) which is coupled to three sets (171 , 172, 173) each comprising one respective anchoring element (171 a, 172a, 173a) fastened to a respective anchoring site (334-1 , 334-2, 334-3). The three anchoring sites are preferably located in a vicinity of the left fibrous trigon, the right fibrous trigon, and substantially equidistant from the left and right fibrous trigons. In this apparatus, the anchoring elements (171 a, 172a, 173a) are coupled to but not attached to the thread (170) and may thus slide along the thread (170). For example, each of the anchoring elements (171 a, 172a, 173a) comprise a ring for passing the thread (170).

[0111] In a preferred example of the invention, the apparatus comprises a first and a second set of anchoring elements (171 , 172) fastened to separate first and second anchoring sites (334-1 , 334-2), respectively, the first and a second set of anchoring elements (171 , 172) each comprising one or more first and second anchoring elements (171 a, 171 b, 172a, 172b), respectively. The first and second anchoring elements (171a, 171 b, 172a, 172b) may be coupled to a same or to separate threads (170, 170-1 , 170-2), and all of the threads may be attached to the implant (180) and pass through the passage (333).

[0112] In the apparatus according to the invention, a thread (170) traversing a passage (333) and coupled to the one or more anchoring elements (171a, 171 b) and attached to the implant (180) may extend between a first end (170a) and a second end (170b). For example, as illustrated in Fig. 3e, the first and second ends (170a, 170b) of the thread (170) may both be attached to the implant (180), and at least one of the one or more anchoring elements (171 a, 171 b) is configured for sliding along the thread (170), or at least one of the one or more anchoring elements (171a, 171 b) is configured for attaching i.e., not sliding along the thread (170). For example, as illustrated in Fig. 3f, the first end (170a) of the thread (170) may be attached to the implant (180) and the second end (170b) of the thread (170) may be coupled to the one or more anchoring elements (171a, 171 b).

[0113] References of the drawings

110 first guidewire

110d first guidewire distal end

120 stabilizing catheter

120a stabilizing catheter longitudinal axis

120d stabilizing catheter distal portion

120p stabilizing catheter proximal portion

120s lateral external surface of the stabilizing catheter distal portion

121 stabilizing catheter handle

122 guiding lumen working lumen a working lumen axis d working lumen distal aperture stabilizing catheter radio opaque part balloon fluid communication lumen needle d needle tip dilator t dilator distal tip dilator lumen d dilator distal aperture second guidewire d second guidewire distal end anchoring catheter d anchoring catheter distal portion suture lumen (in catheter) d suture lumen distal aperture anchoring catheter radio-opaque material part anchoring catheter guiding lumen thread a first end of the thread 170 b second end of the thread 170 -1 thread -2 thread -3 thread set of anchoring elements a anchoring element b anchoring element set of anchoring elements a anchoring element b anchoring element set of anchoring elements a anchoring element 174 proximal part of the thread 170

174-1 proximal part of the thread 170-1

174-2 proximal part of the thread 170-2

174-3 proximal part of the thread 170-3

180 implant

181 implant guiding lumen

182 implant thread lumen

183 locking mechanism

190 implant catheter

200 working catheter

200d working catheter distal portion

201 working catheter lumen

201 d working catheter lumen distal aperture

202 working catheter radio-opaque material part

300 mitral valve

320 coronary sinus

320s internal surface of the coronary sinus

330 left atrium

331 left atrium wall

332 left atrium wall puncturing site

333 passage in the left atrium

334 anchoring site

334-1 anchoring site

334-2 anchoring site

334-3 anchoring site

335 mitral valve anterior annulus

337 mitral valve posterior annulus

P2 P2 area a angle between a direction of the working lumen axis (123a) and a direction of the stabilizing catheter longitudinal axis