Chordal replacement devices and methods

Abstract

A device for connecting artificial chordae tendineae to the leaflets of an atrioventricular valve, the device comprising: a neochord delivery system comprising a manipulable and pushable catheter that houses a neochord attached to a neochord puncture needle, the catheter being operable to push the puncture needle to puncture and pass the neochord through the papillary muscle of the ventricle; a retriever system comprising a catheter that houses a grasper that is operable to capture the neochord puncture needle after it passes through the papillary muscle and remove the neochord puncture needle and the neochord from the ventricle; and a tissue clamping system comprising a catheter that houses a distal tissue clamp and a proximal tissue clamp that can be deployed to clamp and hold the area of ​​the atrioventricular valve located therebetween so that the area can be punctured by the puncture needle to deliver the neochord through the leaflets and to the papillary muscle.

Description

[0001] Related applications

[0002] This application claims the benefit under 35 USC 119(e) of U.S. Provisional Application No. 62 / 870,693, filed on July 4, 2019, the disclosure of which is incorporated herein by reference.

[0003] field

[0004] Embodiments of the present disclosure relate to devices and methods for replacing damaged heart valve chordae with artificial chordae. background

[0005] The human heart contains two blood pumps that operate synchronously to oxygenate and deliver oxygenated blood to the body. The first pump receives deoxygenated blood from various parts of the body and pumps it through the lungs for oxygenation. The second pump receives the blood after it has been oxygenated in the lungs and pumps it through the blood vessels of the circulatory system to deliver oxygen and nutrients to the body. These two pumps are located adjacent to each other in the heart, and each pump consists of two chambers: the atrium that receives blood and the ventricle that pumps blood. The first pump is located on the right side of the heart and includes the right atrium and right ventricle. The second pump is located on the left side of the heart and includes the left atrium and left ventricle.

[0006] In the first pump, deoxygenated blood enters the right atrium, and during the diastole period of the cardiac cycle, the right ventricle is relaxed, and blood flows from the right atrium through the atrioventricular valve, called the tricuspid valve, into the right ventricle. The right ventricle contracts during the systole period of the cardiac cycle, pumping the deoxygenated blood it receives from the right atrium out of the right ventricle, through the pulmonary valve, and into the pulmonary artery for delivery to and oxygenation of the lungs. The tricuspid and pulmonary valves control the direction of blood flow in the right side of the heart. For example, the tricuspid valve opens to allow deoxygenated blood to flow from the right atrium into the right ventricle, and closes to prevent deoxygenated blood from flowing back into the right atrium when the right ventricle contracts.

[0007] In the second pump, the left atrium receives oxygenated blood from the lungs via the pulmonary veins. Oxygenated blood flows from the left atrium into the left ventricle during diastole via a bicuspid atrioventricular valve called the mitral valve. During systole, the left ventricle contracts to pump the oxygenated blood it receives from the left atrium out of the heart, through the aortic valve and into the aorta for delivery to the body. The mitral and aortic valves function to control the direction of blood flow in the left side of the heart. For example, the mitral valve opens during diastole to allow blood to flow from the left atrium to the left ventricle, and during systole, when the left ventricle contracts to pump oxygenated blood into the aorta, the mitral valve closes to prevent oxygenated blood from flowing back from the left ventricle to the left atrium.

[0008] Each atrioventricular valve (tricuspid and mitral) that controls blood flow between the atria and their associated ventricles comprises a set of matching "flaps," also called "leaflets" or "cusps," that are attached to and extend from a supporting ring structure of fibrous tissue known as the annulus of the valve. The leaflets are passive structures that are operated to open and close the valve by the pressure differential across the valve created by the contraction and relaxation of the heart muscles. The leaflets are configured to align and overlap, or close together, along their free edges to close the valve and prevent unwanted retrograde blood flow when the blood pressure gradient across the valve increases during systole of the heart. The valve opens and the free edges separate when the blood pressure gradient across the valve pushes the leaflets apart, and this pressure gradient acts to produce antegrade blood flow through the valve in the desired antegrade direction during diastole of the heart.

[0009] As passive structures, the leaflets of the atrioventricular valves are connected to the valve-associated papillary muscles in the ventricles by tendon-associated cords (called tendinous chordae or simply chordae) that limit the leaflet's range of motion during systole to prevent the leaflet from prolapsing into the atria. Damage to the chordae tendineae of the atrioventricular valve leaflets often results in the leaflets fluttering in the heart's blood flow as the heart pumps and failing to properly close with the other leaflets, leading to regurgitation and poor heart function. The damage may be severe enough to necessitate surgical intervention to repair or replace the valve and provide an acceptable state of health and quality of life for the person with the heart dysfunction.

[0010] Overview

[0011] One aspect of the disclosed embodiments is directed to providing a percutaneous procedure for replacing damaged leaflet chordae tendineae in a patient's atrioventricular heart valve with artificial chordae tendineae, and to devices for performing the procedure. The artificial chordae may be referred to as "neochordas," and the leaflet with the damaged chordae may be referred to as a "flailing leaflet."

[0012] In an embodiment, the procedure includes percutaneously inserting a neochord delivery system comprising a steerable catheter enclosing neochord fibers for replacing damaged chordae into a ventricle associated with an atrioventricular valve of the patient. The distal end of the neochord can be attached to a needle, optionally referred to as a neochord puncture needle, which is configured to puncture papillary muscle tissue. After introduction into the ventricle, the steerable catheter is manipulated to drive the puncture needle and manipulate a portion of the neochord fibers through the papillary muscles in the ventricle. A retriever system is then introduced subcutaneously into the heart and, optionally, through the perturbed valve leaflet into the ventricle. The retriever system is operated to remove the neochord puncture needle and a segment of the neochord fibers attached to the puncture needle from the ventricle, through the perturbed valve leaflet, and from the patient's body.

[0013] In an embodiment, the retriever system includes a retriever catheter containing a grasper and a pull wire attached to the retriever needle. For introduction through the disturbed leaflet, the retriever system can be housed in a tissue clamping system having a clamping catheter, which can include a pair of horseshoe-shaped tissue clamps. To introduce the retriever system into the ventricle and remove the chordae tendineae needle and the new chordae tendineae, the clamping catheter including the retriever system is advanced into the patient's heart to the retrograde side of the atrioventricular valve. The distal end of the tissue clamping catheter is positioned above the disturbed leaflet and the clamp is clamped to an area of ​​the disturbed leaflet to stabilize the position of the area relative to the distal end of the clamping catheter. The retriever needle is then driven through the clamped area to bring the grasper into the ventricle, and the grasper is manipulated to grasp and hold the new chordae tendineae needle driven through the papillary muscle in the ventricle. The pull wire and the grasper holding the new chordal needle are then pulled back into the retriever catheter through the stabilized region of the disturbed leaflet, and the grasper, the new chordal needle held by the grasper, and a section of new chordal fiber are removed through the tissue clamping catheter. In embodiments, the retriever needle and / or grasper may include a magnetized component to aid in attracting and grasping the new chordal needle.

[0014] After removal, the neochordal fibers are anchored to the disturbed leaflets and papillary muscles. Excess neochordal fibers are severed and removed from the patient's body, leaving behind functioning neochords positioned between the leaflets and papillary muscles, which reduce the leaflet disturbance and enable the leaflet to properly coapt with the other leaflet or leaflets of the atrioventricular valve.

[0015] Optionally, the new chords are anchored to the perturbed leaflet using an anchoring device (also known as a "spider-lock") that slides and locks to the new chord fibers and the leaflet on the regurgitant side of the perturbed leaflet before the new chord fibers are cut to remove excess fibers. In accordance with an embodiment of the present disclosure, the spider lock can be slid and locked to the new chord fibers and the perturbed leaflet using a spider-lock deployment system. Optionally, the spider-lock deployment system includes an inner sliding catheter and an outer holding catheter. The catheter holds the spider lock open and unlocked, and the new chord fibers are slidable within the inner "sliding" catheter during delivery of the spider lock along the new chord fibers to the leaflet anchoring position. The spider lock is closed and locked in the leaflet anchoring position by first retracting the inner sliding catheter to lock the spider lock to the new chord fibers, and then retracting the outer "holding" catheter to lock the spider lock to the perturbed leaflet.

[0016] In embodiments, the new chord fibers are anchored to the papillary muscle by a knot, which may be referred to as an "anchor," or by a crimp lock that is pre-positioned along the length of the new chord.

[0017] This Summary is provided to introduce selected concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Non-limiting examples of embodiments of the present invention are described below with reference to the accompanying drawings listed following this paragraph. Identical features appearing in more than one figure are generally labeled with the same reference numerals in all figures in which they appear. Reference numerals used to designate a given feature of an embodiment of the present disclosure in a figure may be used to refer to the given feature. Dimensions of features shown in the figures are selected for ease of presentation and clarity and are not necessarily shown to scale.

[0019] Figure 1A and Figure 1B Schematically illustrates a neochord delivery system according to an embodiment of the present disclosure, the system comprising a steerable catheter housing a segment of neochord fiber attached to a selectively magnetizable neochord puncture needle and each having an anchor knot and a crimp lock;

[0020] Figure 2A Schematically shows an embodiment of the present disclosure Figure 1A The neochordal delivery system shown is housed in a steerable catheter along with a horseshoe-shaped tissue clamp, thereby enabling selective driving of a neochordal puncture needle through a heart valve leaflet;

[0021] Figure 2B Schematically shows an embodiment of the present disclosure Figure 2A A horseshoe-shaped tissue clamp is shown pushed out from the distal end of the catheter;

[0022] Figure 3A and Figure 3B Schematically shows the operation of an embodiment according to the present disclosure Figure 2A and 2B The catheter and horseshoe-shaped tissue clamp shown are used to puncture and drive a neochordal puncture needle and attach to a segment of neochordal fiber through thin tissue;

[0023] Figures 4A-4C Schematically illustrates a retriever system and a method for grasping and holding a retriever system according to an embodiment of the present disclosure. Figures 2A-3B New chordae tendineae puncture needle shown;

[0024] Figure 4D Schematically shows an embodiment of the present disclosure Figures 4A-4C A retriever is shown, the retriever being housed in a steerable catheter along with a horseshoe-shaped tissue clamp so that the retriever can be selectively driven through a heart valve leaflet;

[0025] Figures 5A-5H Component details of a spider lock deployment system and the use of the deployment system are shown according to an embodiment;

[0026] Figures 6A-6L schematically illustrates the percutaneous deployment of new chordae tendineae to the leaflets of a mitral valve via the aortic valve according to an embodiment of the present disclosure; and

[0027] Figure 7 Schematically depicted is the percutaneous deployment of neo-chordae to the leaflets of a mitral valve via a transseptal approach in accordance with an embodiment of the present disclosure. Detailed description

[0028] In the discussion, unless otherwise indicated, adjectives such as "substantially" and "approximately" that modify a condition or relationship characteristic of one or more features of an embodiment of the present disclosure are understood to represent that the condition or characteristic is defined to fall within a tolerance that is acceptable for operation of the embodiment for the application for which the embodiment is intended. Whenever a general term in the present disclosure is illustrated by reference to an exemplary embodiment or a list of exemplary embodiments, the one or more examples referenced are non-limiting exemplary examples of the general term, and the general term is not intended to be limited to the specific exemplary one or more examples referenced. Unless otherwise indicated, the word "or" in the specification and claims is to be considered an inclusive "or" rather than an exclusive "or" and means combining at least one of the items or combining any combination of more than one of the items.

[0029] Figure 1A A new chord delivery system 20 is schematically shown, comprising a steerable catheter 22 containing a section of new chord fiber 30 attached to a new chord puncture needle 31. In an embodiment, the puncture needle comprises a needle 32 placed on the distal end 24 of the steerable catheter 22 and a handle 33 placed in the catheter. The needle 32 remains held and placed on the distal end 24 due to maintaining appropriate tension on the new chord fiber 30 and optionally by friction between the handle 33 and the catheter 22. Optionally, the puncture needle 31 is magnetized, having a Figure 1A The new chord fibers 30 are optionally tied with anchor knots 36 for anchoring the new chord fibers to the papillary muscles or atrioventricular valve leaflets.

[0030] Figure 1B A new tendon delivery system 20 according to an embodiment of the present disclosure is schematically shown. Figure 1A As shown, however, to anchor the new chord, it has a crimp lock 40 instead of a knot. The crimp lock 40 is formed of a shape memory material and comprises a loop 41 and a set of legs 42 that are crimped onto the new chord fiber 30 at appropriate locations along the fiber. Figure 1B When shown within the catheter 22, the crimp lock is in a folded state, with the legs 41 folded back within the catheter 22 along the neochord fibers 30. When released from the catheter 22, the crimp lock assumes an expanded state, in which the legs 42 open to hook into and anchor the spider lock to the tissue area in which it is deployed. Figure 1B Illustration 201 in FIG. 4 shows the crimp lock 40 in an expanded state. The operation of the new chord delivery system 20 is described and discussed below.

[0031] Figure 2AA novel chordal delivery system 20 according to an embodiment of the present disclosure is schematically shown, housed in a tissue clamping system 50 that can be used to facilitate the operation of the novel chordal delivery system to penetrate tissue, such as the leaflets of an atrioventricular valve. The tissue clamping system 50 optionally includes a distal horseshoe-shaped tissue clamp 51 and a proximal horseshoe-shaped tissue clamp 52 housed in a catheter 53. The distal horseshoe-shaped clamp 51 and the proximal horseshoe-shaped clamp 52 can be formed of a shape memory material and maintained in their respective contracted states within the catheter 53. When they are pushed out of the catheter 53, the horseshoe-shaped clamps are configured to assume an expanded state, in which the memory linear shapes they ultimately deform into are horseshoe-shaped shapes 55 and 56, respectively. The horseshoe-shaped shape is configured to grasp and hold tissue layers, such as the leaflets of a heart valve, between them. Figure 2B The distal and proximal horseshoe-shaped clamps 51 and 52 are schematically shown pushed out of the catheter 53 of the clamping system to assume their respective expanded linear shapes having horseshoe-shaped ends 55 and 56. It should be noted that although Figure 2B The middle tissue clamps 51 and 52 take a horseshoe shape when extended from the guide tube 53 , but the tissue clamps according to embodiments may take shapes other than horseshoes and may, for example, take a sewing machine footer shape or a simple ribbon shape.

[0032] Figure 3A Schematically shown are a new chord delivery system 20 and horseshoe-shaped clamps 51 and 52 according to an embodiment of the present disclosure, where the new chord delivery system 20 is housed in a tissue clamping system 50, and the horseshoe-shaped clamps 51 and 52 are pushed out from a catheter 53 to grasp and hold an area 58 of tissue 59 located therebetween. Figure 3B A novel chordal delivery system 20 is schematically shown being advanced from a catheter 53 to penetrate a tissue region 58 held between horseshoe-shaped clamps 51 and 52 in accordance with an embodiment of the present disclosure.

[0033] Figure 4A A retriever system 70 is schematically shown that is configured to attract, grasp, and hold ("capture") a new chordal puncture needle 31 ( Figure 3B ), and the new chordal puncture needle and a section of new chordal fiber 30 attached to the needle are removed from the patient's body.

[0034] The retriever system 70 optionally includes an outer holding catheter 71 and an inner clamping catheter 72. The inner clamping catheter 72 includes a grasper 73 having a set of gripping jaws 74 at its distal end and houses a pushable pull wire 76 attached to a capture needle 77. The capture needle 77 can be magnetized in one direction to generate a magnetic field that attracts the magnetized new chord puncture needle 31 to the capture needle 77. The gripping jaws 74 can optionally be formed of a shape-memory material and have a memory shape, where they open to receive the new chord puncture needle 31, or can be spring-loaded to open but restrained closed by the outer holding catheter 71 when within the holding catheter. The inner clamping catheter 72 can be pushed out of the outer holding catheter 71, over the capture needle 77, to release the gripping jaws 74 from the outer holding catheter 71 and allow them to open and receive the new chord puncture needle 31. A pull wire 76 may be used to hold the capture needle 77 so that the inner clamping catheter 72 can be pushed beyond the capture needle.

[0035] Figure 4B The diagram schematically shows the inner holding catheter 72 and the open clamping jaws 74 being pushed out from the outer holding catheter 71, so that the magnetic field of the capture needle 77 attracts the new chordal needle 31 into the clamping jaws 74 and contacts and attracts the capture needle 77. Once the new chordal puncture needle is inside the clamping jaws 74, as shown in FIG. Figure 4C As schematically shown in FIG, the outer retaining catheter 71 can be pushed distally over the inner clamping catheter 72 to close the clamping jaws 74 and securely retain the new chord puncture needle 31. The clamping jaws and new chord puncture needle 31 along with a length of new chord fiber 30 can be removed from the patient's body by pulling the retriever system 70 out of the body, pulling the inner clamping catheter 72 out of the outer retaining catheter 71, and / or pulling the pull wire 76 out of the inner clamping catheter 72.

[0036] Wire 76 can be used to push capture needle 77 out of clamping catheter 72 and holding catheter 71 so that retriever 70 can puncture and pass through tissue, such as atrioventricular valve leaflets, to position the retriever at a desired location. By way of example, Figure 4D The retriever 70 ( Figure 3A and Figure 3B , which houses the new chordal delivery system 20) and a wire 76 that is pushed distally to push the capture needle 77 out of the retriever so that the retriever can penetrate and pass through the tissue area held by the horseshoe-shaped clamps 51 and 52 ( Figure 4D not shown).

[0037] Figure 5AA spider lock delivery system 80 in accordance with an embodiment of the present disclosure is schematically shown sliding over a section of neo-chordal fiber 30 that has passed through, for example, region 213 of an atrioventricular valve leaflet 212 to lock a shape memory spider lock 90 to the neo-chordal fiber and tissue region.

[0038] The delivery system 80 includes an inner sliding catheter 81 in which the neochord fibers 30 slide freely, and a concentric outer retaining catheter 82. The spider lock 90 optionally includes a support ring 91 that supports optionally four cable clamps 92 and optionally four legs 94 having barbed ends 95. The cable clamps 92 grip the inner sliding catheter 81 and the barbed ends 95 bite into and retain the inside of the outer retaining catheter 82. The retaining catheter 82 optionally includes an engagement fork 84 that engages the support ring 91 to help hold the spider lock 90 in place at the distal end 86 of the retaining catheter 82.

[0039] Figure 5B The delivery system 80 is schematically shown having been slid distally over the neochord fibers 30 to an anchoring region 215 along the neochord fibers adapted to anchor the spider lock 90 to a region 213 of the neochord fibers and leaflets 212. Figure 5C In the embodiment of the present invention, the sliding catheter 81 is moved proximally away from the spider lock 90 and the anchoring area 213 to enable the cable clamp 92 to snap onto the new chord fibers 30 and clamp the spider lock 90 to the new chord fibers. Figure 5D The sliding catheter 81 is then moved distally to contact and rest on the cable clamp 92 to hold the spider lock in place on the leaflets 212 while the outer holding catheter is moved to release the spider legs 94 to deploy and attach the spider lock 90 to the leaflets 212, as shown. Figure 5E and Figure 5F As shown. Figure 5G As schematically shown in FIG, both the sliding catheter 81 and the retaining catheter 82 are removed distally from the spider lock 90 and the patient's body, leaving the patient as shown. Figure 5H The schematic diagram in FIG shows a new chordal fiber 30 tied to the leaflet 212 and with the artificial new chord in place, the new chordal fiber 30 is ready to be disconnected from the redundant fibers.

[0040] Figures 6A-6LA percutaneous procedure according to an embodiment of the present disclosure is schematically illustrated for replacing the chordae tendineae of the anterior leaflet of the mitral valve of an optional patient (not shown) with neochordae tendineae utilizing a neochordae delivery system 20, a tissue clamping system 50, a retriever system 70, and a spider lock delivery system 80. The accompanying drawings schematically illustrate a cross-sectional view of a patient's heart 100 showing the left atrium 102, the left ventricle 104, and the mitral valve 110 connecting them. The mitral valve 110 has an annulus 111, an anterior leaflet 112, and a posterior leaflet 114, which are shown for ease of illustration in FIG. Figures 6A-6L The esophagus can be dissected at different angles. Optionally, the procedure is performed with transesophageal echocardiography (TTE) and / or intracardiac echo (ICE) imaging.

[0041] In an embodiment employing a transfemoral approach, a catheter 120 is passed into the patient's heart 100 and used to introduce the neochordal delivery system 20 ( Figure 1A ), optionally through the aortic valve 106 and into the left ventricle 104, as Figure 6A As shown schematically. Figure 6B In the embodiment of the present invention, the catheter 22 of the delivery system 20 is pushed out from the catheter 120 and manipulated to push the new chordal puncture needle 31 through the papillary muscle 108 in the left ventricle. Thereafter, in a transseptal approach, the retriever system 70 ( Figure 4D ) is introduced into the left atrium 102 of the heart, and horseshoe-shaped clamps 51 and 52 are deployed to grasp and hold the anterior leaflet 112 of the mitral valve 110, as Figure 6C Shown schematically.

[0042] In deploying horseshoe-shaped clamps 51 and 52, distal horseshoe-shaped clamp 51 is first passed through the opening of mitral valve 110 between the edges of mitral valve leaflets 112 and 114, where the leaflets meet, with horseshoe-shaped end 55 positioned below anterior leaflet 112. Proximal horseshoe-shaped clamp 52 is then extended to anterior leaflet 112, with horseshoe-shaped end 56 positioned above anterior leaflet 112. The distal and proximal horseshoe-shaped clamps are then manipulated to approximate each other and clamp the desired region of the anterior leaflet therebetween. Figure 6C Schematically depicted are the deployed distal clamp 51, proximal clamp 52, and horseshoes 55 and 56, which clamp therebetween a desired region 113 of the anterior leaflet 112. The retriever 70 is then advanced out of the tissue clamping system 50 to puncture the anterior leaflet 112 in the region 113 clamped by the clamping system 50 and into the ventricle 104. Figure 6D The retriever 70 is schematically shown after entering the ventricle.

[0043] After being introduced into the ventricle 104, the retriever 70 is operated to capture the new chordal needle 31, as described above with reference to Figures 4A-4C As stated. Figure 6E and Figure 6F The retriever system 70 is schematically shown capturing the new chordal needle 31 in the ventricle 104 of the heart 100. The retriever system 70 is then removed from the ventricle 104 through the area 113 clamped by the horseshoe-shaped clamps 51 and 52 to pull the new chordal needle 31 and a section of the new chordal fiber 30 into the catheter 53 of the tissue clamping system and out of the patient's body from the heart 100. The new chordal needle 31 and the new chordal fiber 30 are pulled a certain distance outside the patient's body so that the anchor knot 36 tied in the new chordal fiber is stuck and anchors the new chordal fiber in the papillary muscle 108. Figure 6H The schematic diagram shows the neochordal fibers 30 and the catheter 53 of the clamping system in the heart 100 after the anchoring knot 36 is captured in the papillary muscle 108. The horseshoe-shaped clamps 51 and 52 are then detached from the anterior leaflet 112, retracted into the catheter 53 of the tissue clamping system, and the clamping system 50 is removed from the body, leaving the neochordal fibers 30 anchored in the papillary muscle and passing through the heart 100 and the inferior vena cava (IV) to the outside of the body. Figure 6I The new chord fibers 30 are schematically shown after the clamping system 50 has been removed from the patient's body.

[0044] In an embodiment, after the clamping system 50 is removed, the spider lock delivery system 80 ( Figures 5A-5H ) onto the new chordae tendineae 30, into the left atrium 102 and position the spider lock 90 on the retrograde side of the anterior leaflet 112, as shown in FIG. Figure 6J As shown schematically. Figures 5A-5H The spider lock delivery system 80 is operated as shown to lock the spider lock 90 to the new chord fibers 30 and the anterior leaflet 112. The delivery system is then removed from the body, leaving the new chord fibers 30 anchored to the papillary muscles 108 and the anterior leaflet 112, as shown. Figure 6K The excess new tendon fibers extending from the papillary muscles through the heart and vena cava to the outside of the body and from the papillary muscles 108 through the aortic valve and femoral artery to the outside of the body are removed, leaving Figure 6L Functional neochordae are shown.

[0045] Note that although Figures 6A-6L The procedure is schematically shown with the catheter 120 delivering the neochord delivery system 20 across the aortic valve 106, but in embodiments, the neochord delivery system 20 can be introduced into the left ventricle via a transseptal approach. In a transseptal approach, the neochord delivery system 20, along with the clamping system 50 and the retriever system 70 ( Figure 6C-6H) is introduced into the left atrium via a puncture in the septum of the heart, either through the same puncture in the septum or through a different puncture in the septum. By way of example, Figure 7 The schematic diagram shows the introduction of the new chordal delivery system 20 into the ventricle 104 through the septum, according to an embodiment. Figure 7 , after puncturing the cardiac septum, the neochordal delivery system is introduced into the ventricle between the edges of the anterior and posterior leaflets 112, 114 using a transseptal approach.

[0046] Note further that, despite Figures 6A-6L and Figure 7 The procedure schematically illustrates the neochordal delivery system 20 being introduced into the ventricle 104 through the aortic valve 106 or through the space between the edges of the mitral valve using a transseptal approach, but practice of the disclosed embodiments is not limited to the delivery arrangements shown in the figures. The retriever system 70 can be introduced into the ventricle 104 through the aortic valve 106 or through a puncture in the leaflets of the mitral valve.

[0047] Therefore, according to an embodiment of the present disclosure, there is provided a device for connecting artificial chordae tendineae to the leaflets of an atrioventricular valve, the device comprising: a new chord delivery system, the new chord delivery system comprising a manipulable and pushable clamping catheter, the clamping catheter accommodating the new chord attached to the new chord puncture needle, the clamping catheter being operable to push the puncture needle to puncture and pass the new chord through the papillary muscle of the ventricle; a retriever system, the retriever system comprising a retriever catheter accommodating a grabber, the grabber being operable to capture the new chord puncture needle after the new chord puncture needle passes through the papillary muscle, and remove the new chord puncture needle and the new chord from the ventricle; and a tissue clamping system, the tissue clamping system comprising a clamping catheter accommodating a distal tissue clamp and a proximal tissue clamp, the distal tissue clamp and the proximal tissue clamp being deployable to clamp and hold the area of ​​the atrioventricular valve located therebetween so that the area can be punctured to allow the new chord to pass through the leaflets.

[0048] Optionally, the clamping catheter can slidably receive the new chord catheter. Alternatively, the clamping catheter can slidably receive the retriever catheter.

[0049] In an embodiment, the retrieval catheter houses a gripping catheter having a distal end to which a set of gripping jaws are attached. Optionally, the retrieval system includes a capture needle for coupling to the introducer needle. The device may include a pushable pull wire having a distal end to which the capture needle is attached. Optionally, the pushable pull wire is housed in the gripping catheter.

[0050] In an embodiment, the puncture needle and the capture needle are magnetized. The distal ends of the puncture needle and the capture needle may have opposite magnetic polarity.

[0051] In an embodiment, the expanded shape of the proximal clamp comprises a horseshoe-shaped end for clamping the atrioventricular valve region. In an embodiment, the expanded shape of the distal clamp comprises a horseshoe-shaped end for clamping the atrioventricular valve region.

[0052] The device may include a lock deployment system operable to lock the new chordae tendineae to the atrioventricular valve leaflets and comprising: a first catheter having an inner lumen in which the new chordae tendineae are slidably received; a new chord lock having an unlocked state and a locked state, in which the lock grasps the first catheter and is slidable along the new chordae tendineae, and in which the new chord lock does not grasp the first catheter and is locked to the new chordae tendineae and the atrioventricular valve leaflets; a second catheter receiving the first catheter and the new chord lock in the unlocked state, wherein the lock is pressed against and retained on the inner surface of the second catheter; wherein the lock is releasable to lock to the new chordae tendineae and the atrioventricular valve leaflets by sliding the first catheter and the second catheter relative to each other.

[0053] Optionally, the new chord lock includes a plurality of cable clamps, and in the unlocked state the cable clamps clamp the first catheter and in the locked state the cable clamps clamp the new chords. The new chord lock optionally includes a plurality of legs that extend in a direction substantially perpendicular to the first catheter to enable the lock to clamp and lock to tissue of the atrioventricular valve leaflets. Optionally, in the unlocked state, the legs fold back in a proximal direction to press against an inner surface of the second catheter, and in the locked state the cable clamps open to extend and lock the lock to tissue of the atrioventricular valve leaflets. Optionally, the legs are shaped to have barbed ends that pierce tissue of the atrioventricular valve leaflets to lock the lock to tissue of the atrioventricular valve leaflets.

[0054] According to an embodiment, a tissue clamping system is also provided, which includes: a clamping catheter; a first tissue clamp, the first tissue clamp including a first pushable stem wire extending along the clamping catheter, and including a first clamping end maintained in a tightened state within the clamping catheter, and the first clamping end presents an expanded state when pushed out of the clamping catheter; and a second tissue clamp, the second tissue clamp including a second pushable stem wire extending along the clamping catheter, and including a second clamping end maintained in a tightened state within the clamping catheter, and the second clamping end presents an expanded state when pushed out of the clamping catheter; wherein the first clamping end and the second clamping end can be sequentially pushed out of the clamping catheter to clamp an area of ​​the tissue layer located between them.

[0055] According to an embodiment, there is also provided a device for attaching a new chord to a leaflet of an atrioventricular valve of a heart, the device comprising: a tissue clamping system according to an embodiment of the present disclosure; a new chord delivery system operable to puncture and pass the new chord through the leaflet region clamped by the clamping system and pass the new chord through the papillary muscle of the ventricle of the heart; and a retriever system operable to capture the new chord puncture needle after the puncture needle has punctured and passed the new chord through the papillary muscle. Optionally, the new chord delivery system or the retriever system is housed in a clamping catheter.

[0056] According to an embodiment, there is also provided a lock deployment system operable to lock a fiber to a tissue region, the system comprising: a first catheter having an inner lumen in which the fiber is slidably received; a fiber lock having an unlocked state and a locked state, wherein the lock grasps the first catheter and can slide along the fiber, and wherein the fiber lock does not grasp the first catheter and is locked to the fiber and the tissue region; a second catheter receiving the first catheter and the fiber lock in the unlocked state, wherein the lock is pressed against and retained to an inner surface of the second catheter; wherein the lock is releasable to lock the fiber and the tissue region by sliding the first catheter and the second catheter relative to each other.

[0057] In the description and claims of this application, each verb "comprise," "include," and "have" and its cognates are used to indicate that one or more objects of the verb are not necessarily a complete enumeration of the parts, elements, or portions of the one or more subjects of the verb.

[0058] The description of the embodiments of the present invention in this application is provided by way of example and is not intended to limit the scope of the invention. The described embodiments include different features, not all of which are required in all embodiments of the invention. Some embodiments utilize only some features or possible combinations of features. Those skilled in the art will recognize variations of the described embodiments of the invention, as well as embodiments of the invention including different combinations of the features mentioned in the described embodiments. The scope of the invention is limited only by the claims.

[0059] The description of the embodiments of the present invention in this application is provided by way of example and is not intended to limit the scope of the invention. The described embodiments include different features, not all of which are required in all embodiments of the invention. Some embodiments utilize only some features or possible combinations of features. Those skilled in the art will recognize variations of the described embodiments of the invention, as well as embodiments of the invention including different combinations of the features mentioned in the described embodiments. The scope of the invention is limited solely by the appended claims.

Claims

1. A device for connecting artificial chordae tendineae to atrioventricular valve leaflets, the device comprising: a neo-chord delivery system comprising a steerable and pushable clamping catheter housing a neo-chord attached to a neo-chord puncture needle, the steerable and pushable clamping catheter being operable to push the neo-chord puncture needle to puncture and pass the neo-chord through a papillary muscle of a ventricle; a retriever system comprising a retriever catheter housing a grasper operable to capture the neo-chordal puncture needle after it has passed through the papillary muscle and to remove the neo-chordal puncture needle and the neo-chord from the ventricle; as well as A tissue clamping system comprising a clamping catheter, the clamping catheter of the tissue clamping system accommodating a distal tissue clamp and a proximal tissue clamp, the distal tissue clamp and the proximal tissue clamp being deployable to clamp and hold an atrioventricular valve region located between the distal tissue clamp and the proximal tissue clamp so that the region can be punctured to pass the new chordae tendineae through the atrioventricular valve leaflets.

2. The device according to claim 1, wherein The steerable and pushable clamping catheter slidably receives the new chordal catheter.

3. The device according to claim 1, wherein The steerable and pushable clamping catheter slidably receives the retriever catheter.

4. The device according to claim 1, wherein The retriever catheter houses a gripping catheter having a distal end to which a set of gripping jaws are attached.

5. The device according to claim 4, wherein The retriever system includes a capture needle for coupling to the new chordal puncture needle.

6. The device of claim 5, comprising a pushable pull wire having a distal end, the capture needle being attached to the distal end.

7. The device according to claim 6, wherein The pushable pull wire is housed in the clamping catheter.

8. The device according to claim 5, wherein The new chordal puncture needle and the capture needle are magnetized.

9. The device according to claim 8, wherein The distal ends of the new chordal puncture needle and the capture needle have opposite magnetic polarities.

10. The device according to claim 1, wherein In the expanded shape, the proximal tissue clamp includes a horseshoe-shaped end for clamping the atrioventricular valve region.

11. The device according to claim 1, wherein In the expanded shape, the distal tissue clamp includes a horseshoe-shaped end for clamping the atrioventricular valve region.

12. The device of claim 1 , comprising a lock deployment system operable to lock the neo-chordae to the atrioventricular valve leaflets and comprising: a first catheter having an inner lumen in which the neo-chord is slidably received; a new chord lock having an unlocked state in which the new chord lock clamps the first catheter and is slidable along the new chords, and a locked state in which the new chord lock does not clamp the first catheter and is locked to the new chords and atrioventricular valve leaflets; a second catheter receiving the first catheter and the new chord lock in the unlocked state, wherein the new chord lock is pressed against and retained on an inner surface of the second catheter; Wherein the neo-chord lock is releasable to lock to the neo-chords and atrioventricular valve leaflets by sliding the first catheter and the second catheter relative to each other.

13. The device according to claim 12, wherein The new chord lock includes a plurality of cable clamps, and in the unlocked state the cable clamps clamp the first conduit and in the locked state the cable clamps clamp the new chord.

14. The device according to claim 13, wherein The new chord lock includes a plurality of legs extending in a direction substantially perpendicular to the first catheter to clamp and lock the new chord lock to tissue of the atrioventricular valve leaflet.

15. The device according to claim 14, wherein In the unlocked state the legs are folded back in a proximal direction to press against the inner surface of the second catheter, and in the locked state the cable clamp is expanded to extend and lock the new chord lock to the tissue of the atrioventricular valve leaflets.

16. The device according to claim 15, wherein The legs are formed with barbed ends that pierce tissue of the atrioventricular valve leaflets to lock the neochordal lock to the tissue of the atrioventricular valve leaflets.

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