RS20060147A - Implant, apparatus and implantation method for catheter based mitral valve repair - Google Patents

Abstract

Method and devices include novel suture composition, catheter type suture transporters, pushers " and tying instruments, implant for anchoring ono mitral leaflet, myocardial free wall entry site, occluder, and technique for catheter based treatment of mitral regurgiation is represented. In one embodiment, a leaflet tension apparatus is implanted to adjust the systolic leaflet aplitude excursion. A continuous guiding suture track is created from teh direct left ventricular puncture site through one or two puncture sites of the leaflet (1114) via the transseptal catheter to the exit of femoral vein, a pledget-implant (84) is apposed onto the exeriorsized distal (venous) suture end via its integrated suture part and is anchored onto the atrial leaflet surface (11141) by retracting the guiding suture from the epicardial end. Silicon tube (70 ) is interposed between the leaflet and the free myocardiall wall (1113) covering the implant's integrated suture (841) which are directed through the free myocardial wall oclluder (90) and secured to its epicardial segment by an adjustable knot (9021 x 841) so as to keep the leaflet at the wanted distance during systole whilst the valve opening remains unhindered.

Description

Implant, device and method of implantation for catheter-based

mitral valve reconstruction

Field to which the invention relates

The invention belongs to the broad field of medicine, especially minimally invasive heart surgery and interventional cardiology, and relates to the reconstruction of a diseased insufficiency mitral valve on a beating heart using the catheterization technique.

According to the international classification of patents (IPC < IPC), the designation is A61B17/00, A61B17/068, A61B17/122.

Technical problem

The invention expands the range of treatment of the impossibility of closing (insufficiency-regurgitation) of the mitral valve (valve) due to excessive mobility of one or both of its leaflets (cuspis) on the beating heart by catheterization and/or minimally invasive technique under roentgen and/or ultrasound control.

State of the art

The human heart consists of two atria (right and left separated by a partition wall) and two chambers separated by a septal wall. Between the atria and the ventricles there are valves that, when opened, let blood flow from the atria into the ventricles, and when closed, do not allow blood to return back. Between the right atrium and the right ventricle there is a tricuspid valve, and between the left atrium and the left ventricle there is a two-leaf mitral valve. The ventricles transport blood to the lungs and the whole organism via the pulmonary artery or aorta. Between the right ventricle and the pulmonary artery is the pulmonary valve, and between the left ventricle and the aorta is the aortic valve. The mitral and tricuspid valves are connected by thin structures - threads (chordae tendineae) to parts of the inner wall of the ventricular muscles (papillary muscles). During the closing of the mitral or tricuspid valve, these threads are tightened like parachute cords and thus do not allow the leaflets of the valve to protrude excessively backwards towards the atrium, which would lead to the impossibility of complete closure of the valve and the passage of blood backwards towards the atrium. Disturbances in the function of the diseased valve can be due to delayed opening (stenosis narrowed valves) or the impossibility of complete closing-sealing (insufficiency or regurgitation) of the valve. The valves of the left heart (mitral and aortic) often get sick because the pressures in the left heart are higher than in the right. Mitral valve stenosis is treated either by dilation with a catheterization balloon or by surgical dilation (introduction of a metal instrument through the top of the left ventricle on a beating heart to the torn valve, or by introducing a finger through the atrium to the valve - closed

commissurotomy, or on an open heart under eye control cutting the fused ends of the valve - open commissurotomy), or complete valve replacement (cutting

patients with the installation of an artificial valve). Conventional surgical technique for the treatment of mitral valve insufficiency involves either replacing the valve with an artificial one or boiling-reconstruction (repair) of the diseased structures of the valve in an open heart with the application of extracorporeal blood flow. Reconstruction of the mitral valve involves cutting, joining and sewing of the leaflets themselves or shortening, lengthening, moving or implantation of artificial threads - tensioners of the valve leaflets (chordae tendineae) or parts of the muscles that hold the threads (papillary leaflets) or the so-called new-shaping of the ring on which the valve rests (annuloplasty). More recently, the so-called "Alfieri" technique has been applied (Alfieri O, Maisano F, DeBonis M, et al. The edge-to-edge technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg 2001;122:674-81). : Two leaflets of an insufficient mitral valve are sewn together in their middle so that when they close, both leaflets touch each other and thus fit better on each other - they seal, preventing blood from flowing back. Recently, there are attempts to treat mitral insufficiency with interventional cardiology techniques and minimally invasive techniques. Patent US 2005149182 describes the technique of mitral annulus implantation by catheterization. This technique can help in cases of enlargement

of the mitral valve support ring, but it is not useful in cases of excessive mobility of the leaflets or in cases of elongated filaments of the leaflet holders. Patent WO 99/00059 describes the application of minimally invasive treatment of mitral insufficiency with a so-called clip (clip): Approaching through the top of the left ventricle, an instrument is introduced which (as with a toothed clip) captures the middle of both mitral leaflets and clamps it, and then the clip is released from the control element and remains suspended in the middle of both leaflets, thus imitating surgical suturing in the middle of both leaflets - according to Alfieri.

The solution to the problem of capturing the middle of both mitral leaflets on a beating heart is described in AU2004229028 and experimentally applied by Alfieri (Alfieri O, Elefteriades JA, Chapolini RJ, et al. Novel suture device for beating-heart mitral leaflet approximation. Ann Thorac Surg 2002;74:1488-93.). Patent: US6626930 describes integrated solutions presented in patents WO 99/00059 and AU2004229028 on the application of minimally invasive catheter-based clips method. After experiments on animals, this technique was applied as part of a preliminary study and on a smaller number of patients with satisfactory results (Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous Mitral Valve Repair Using the Edge-to-Edge Technique Six-Month Results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 2005;46:2134-40). This technique enables the treatment of mitral insufficiency via catheter without opening the chest on the beating heart. To perform it, access to the left atrium is required with a large, thick tubular catheter (sheath) of 24 Fr (about 7 mm), which is burdensome for the entrance from the inguinal vein. The procedure for capturing the middle of the leaves is complex and the clips made of metal covered with artificial polyester material are relatively large in size. There is a possibility that the rod will come off (which is already described in the study), and this prosthesis is relatively thrombogenic, and there is a possibility of trauma to blood elements. Since it is made of rigid material (metal) and has relatively large dimensions inside the left ventricle, where the movements of all structures are dynamic, there is a possibility of mechanical damage to nearby tissues.

Exposition of the essence of the invention

The goal of the invention is to create aids and develop the technique of their application for minimally invasive catheter intervention on the insufficiency of the mitral valve in conditions of a beating heart, which would enable the control of the movement amplitudes of the mitral leaflets individually or together.

The goal of the invention is to perform the mentioned procedure by implanting artificial tendons (chordae tendineae) without making a surgical knot inside the heart.

The aim of the invention is further that the mentioned procedure can be performed through small-sized introducer catheters.

The goal of the invention is to use only elastic, smooth, non-traumatic materials similar to natural structures, such as polymers, polyesters, etc., as implanted components on the mitral valve and inside the heart cavity. silicon, nylon, PTFE polytetrafluoroethylene or biological materials such as the pericardium.

Visual control of the procedure would be possible with Roentgen-fluoroscope and Ultrasound, which enable visibility even in the blood-filled spaces of the beating heart. The stated goals are achieved by applying the following techniques and aids: Access to the left ventricle through the apex (apex) by direct transthoracic percutaneous puncture under the control of Roentgen or Echocardiography or visual control after minimally invasive access (thoracoscope) to the apex of the left ventricle; Insertion of an introducer catheter of appropriate dimensions or installation of a catheter-type working channel from the surface of the chest through the intercostal space to the pericardium can be done as described in patents US 2003114796, WO 2004028613, WO03066147. Using the Seldinger technique (the technique of inserting a catheter into a blood vessel or heart via a previously introduced guide wire that was introduced through a puncture needle), a sheath of small dimensions (n.p 6 or 7 Fr= ca 2-2.3 mm) is introduced into the left ventricle - a procedure that was used for diagnostic purposes (Ommen SR, Higano ST, Nishimura RA, Holmes DR Jr. Summary of the Mayo Clinic experience with direct left ventricular puncture. Cathet Cardiovasc Diagn 1998 Jun;44(2): 175-9.); Under the control of ultrasound from the esophagus (TEE = transoesophageal echo), a puncture needle protected by a plastic tube (dilator) of the appropriate length and shape is inserted through the mentioned sheath to puncture the desired place on the mitral valve. After the puncture is performed, a protective plastic dilator tube is pulled through the puncture site from the LV to the left atrium through the tip of the puncture needle. This step can be done either at the moment when the valve is well expanded in the phase of spontaneous closure or after keeping the valve in an expanded half-closed position using a catheter-based manipulator-valve holder. As a manipulator for the fixation of the mitral leaflets, the umbrella was introduced via a previously placed wire track from the femoral vein through the right and left atrium through the mitral valve to the aorta and femoral artery as described (Babic UU, Grujicic S, Popovic Z et al. Double-umbrella device for transvenous closure of patent ductus arteriosus and atrial septal defect: first experience. J Interv Cardiol. 1991;4(4):283-94, Sievert H, Hausdord G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale (multi-institutional European trial). Am J Cardiol 1998 Dec 1;82(11): 1405-13. Alternative holding of the mitral leaflet and/or leaflets during the puncture is possible with an instrument specially designed for that purpose with access from the apex of the left ventricle, which is described in detail in the following text. It is also possible to keep the valve in a predominantly closed state by rapid electrostimulation of the heart with a pacemaker - a method known in interventional cardiology.

After puncturing the selected place of the mitral valve, the needle is pulled out and a guide thread with a spiral wire sheath on its initial (distal) part is placed through the dilator using the original suture pushers for better X-ray visibility (original construction of the guide thread) from the left ventricle through the mitral valve to the left atrium. With the conventional technique, a catheter with the appropriate diameter of the inner tube (transseptal sheath) is introduced through the femoral inguinal vein into the left atrium (8 Fr transseptal sheath). A lasso type catheter is introduced through this sheath (n.p. Lassos Firme Osypka GmBH Germany - described in "Sievert H, Babic UU, Hausdord G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS (multi-institutional European trial). Am J Cardiol 1998 Dec 1;82(11): 1405-13". Under Roentgen control, the wire end is grasped with the lasso catheter guide wire in the left atrium and is pulled out through the sheath through the inguinal vein. An originally constructed implant (pledget) made of polymer or biological material is mounted and the guide wire is pulled back through the transseptal sheath and further to rest on the mitral valve. The dilator is pulled back over the guide wire through the sheath in the left ventricle. the end of the guide thread (which is located outside the body before entering the top of the left ventricle) an elastic thin polymer (e.g. silicone or PTFE) hose is pulled on - a hearing stabilizer (similar to the one that covers the implantation electrodes of a pacemaker) slightly longer than the length of the distance from the top of the left ventricle to the mitral valve in the closed position. This tube is pushed over the guide wire of the catheter introducer (dilator) so that one end of the tube tightly touches the mitral valve at the point where the thread passes through it, and the other end tightly touches the inside of the heart muscle at the point of entry of the introducer catheter (sheath) in the top of the left ventricle. By externally tightening the nylon thread (which is attached to the implant by the intracardial end), the implant that is located on the atrial surface of the mitral valve is pulled and pressed towards the end of the silicone tube, which, guided by the thread, is placed on the puncture site of the valve on the ventricular surface of the valve. Since both the thread and the ear are flexible, opening the mitral valve is not disturbed. The entry point (puncture point) into the top of the left ventricle is closed with an originally made closure (occluder). An occluder made of polymer (n.p. silicone) edges and a polyurethane or polyvinyl alcohol sponge in the central part is introduced through the introducer catheter through the extracorporeal proximal remaining end of the thread into the top of the left ventricle, where it is additionally compressed - the auditory stabilizer placed between the wall of the left ventricle and the punctured site of the mitral leaf (observed in the valve closing phase) and over the guide thread.

By tightening the thread - by pulling its end that remained outside the heart, the implant (resting on the atrial surface of the valve) and the measuring hearing stabilizer (pulled over the thread from the ventricular entrance to the contact with the mitral valve on the ventricular side) are tightened, the amplitude of the movement during the closing of the mitral valve is dosed to the desired level under ultrasound control. When, by tightening the thread, the amplitude of the closing movement of the manipulated valve (during systole) is brought to the desired level, the outer extracorporeal end of the thread is tied to the outer element of the occluder of the inlet opening of the apex of the heart muscle of the left ventricle. On the originally constructed occluder, there is an already installed end of the thread with a preformed knot of the loop type (loop knot), which, after connecting with the end of the thread from the heart, is tied and tightened with catheter-type tensioners (knot pushers), and the ends of the thread are cut with catheter scissors (suture knot cutter), leaving the implant lying on the atrial side of the mitral valve, taut - connected with a thread to the occluder (occluder) in the muscle of the top of the left ventricle and supported and stabilized by the ear located between the inside of the tip of the left ventricular muscle and the ventricular surface of the mitral valve and over the thread.

The mentioned application of technique and aids is its simple typical example.

The aids and techniques of this invention can be used in other locations such as other heart valves and other heart structures as well as other parts of the body. Any medically suitable thread material can be used as a guide thread. The implant (pledget) that rests on the mitral valve from the atrial surface can be tightened with two or more guide threads, which gives it the shape of a branched (arborization) natural string of tension (chordae tendineae), and after puncturing the mitral leaf in 2 or more selected places. It is also possible to apply this technique to both valves at the same time, where after individual punctures of the anterior and posterior valves, a silicone implant is tightened over the guide threads for both central parts of the valves from the atrial side, and from the ventricular side, a stabilizing tube is pulled over both threads and pulled to the contact of both leaflets, thereby performing the function of a surgical knot, and thus the central part of both valves is joined as in the mentioned "Alfieri" procedure without the need to tie a surgical knot on with a beating heart.

Brief description of the draft images

Figure 1 shows a longitudinal section of a set for transthoracic (directly through the chest) puncture of the left ventricle and mitral valve.

Figure 2 shows a longitudinal section of the originally constructed suture thread within the heart with a guiding function and a radiopaque part for X-ray visibility.

Figure 3 shows a longitudinal section of a catheter-type suture material transporter inside the blood vessels (or catheter) and the cavity in the function of pulling the instrument back, leaving the thread (suture) in the same place.

Figure 4 shows the pusher (suture pusher) from Figure 3 in the function of pushing the thread into the limited space of the catheter.

Figure 5 shows a longitudinal section of a catheter-type instrument for inserting a thread (suture) into a catheter-type device in the open state.

Fig. 5B shows the instrument from Fig. 5A in the function of fixing a thread (suture) within the catheter space and ready for a pulled (pulling) maneuver into a catheter-type instrument.

Figure 6 A shows a catheter-type pusher knot made outside the body for transport to remote areas of the blood vessels and heart.

Figure 6B shows another variant of the instrument of Figure 6A.

Figure 6C shows a catheter-type knot pusher showing the thread and knot.

Figure 7 A and B shows a stabilizing hose-tube (tube) as a supporting element in the construction of a functional artificial mitral leaflet tension thread (cuspis).

Figure 8 A shows a schematic of the tissue protector implant (pledget) on the mitral cusps from the atrial and ventricular sides.

Fig. 8B shows a variant of Fig. 8A of the implant with details of the part that abuts the atrial surface of the mitral leaflets and the part that supports from the ventricular surface of the mitral valve leaflets.

Figure 8C shows an additional variant of the implant shown in Figures 8A and B with a part that rests on the atrial surface of the mitral leaflets and already integrated extension threads (suture) in which a spiral is installed to receive the ends of the guide thread - by which the implant is connected to the guide rail.

Figure 8 D shows a variant of the implant of Figure 8C having integrated sutures at both ends of the implant with spiral elements on both sides ready to connect to the ends of the 2 guide sutures.

Figure 9 shows the occluder of the defect (opening-channel) of the free wall of the splenic muscle.

Figure 10 A shows the method of keeping the mitral leaflets in a closed or semi-closed position (mitral valve manipulator) so that they can be punctured with a needle.

Figure 10B shows another variant of the method of Figure 10A.

Figure 11 shows a schematic of the left heart with the atrium and the ventricle between which the mitral cusps are located. Puncture of the posterior mitral cusp with a long puncture needle (without a lumen) covered with a tube-type catheter (polyurethane dilator) of small diameter.

Figure 12 shows the introduction of a special guide wire with a spiral metal part through the tube from the outer wall of the heart to the left ventricle through the back leaf of the mitral valve into the left atrium.

Figure 13 shows the capture of the end of the inserted thread (suture) in the left atrium with a special "lasso" catheter.

Figure 14 shows a diagram of tightening the loosened posterior mitral valve leaf (posterior mitral cusp) with a new technique.

Figure 15 shows a schematic of the anterior mitral cusp tightening with the new tightening technique using the implant of Figure 8C.

Figure 16 shows a diagram of the formation of a double-striped guide wire rail for tightening the loosened anterior mitral leaflet.

Figures 17 and 17B show the anterior mitral leaflet tightening procedure using the implant of Figure 8D.

Figure 18 shows a diagram of the formation of a double guideway through both (posterior and anterior) mitral leaflets for the procedure of their joining at the moment of closure (systole). Figure 19 shows catheter-based knot tying with a knot pusher on the outer surface of the heart introduced through an introducer catheter.

Figure 20 shows the cutting of the ends of the knotted thread with catheter-based scissors on the outer surface of the heart introduced through the introducer catheter.

Figure 21 shows a procedure that functionally disables the movements of the central parts of the free edges of both mitral leaflets.

Figure 22 shows the procedure shown in si 21 with the enhancement of the limiting function of the closure of both central parts of the valve with the addition of a left ventricular implant.

Detailed description of the invention

The individual devices of the invention are shown in detail in the drawings (figure 1-10), and their application and stages of the procedure in figures 11-20.

Figure 1 shows a longitudinal section of a kit for direct puncture of the left ventricle through the sternum intercostal space. The set consists of a needle 11 without a central channel (no lumen) with a sharpened initial (distal) part 12 and a blunt (proximal) end 13 made of medical stainless steel 20-25 cm long and up to 1 mm thick. The needle is covered with a plastic catheter (angiographic dilator) 21 with a central channel that ends with an opening 22 and 23 through which a puncture needle 11 is introduced. Figure 2 shows the original construction of the guide wire 30, the initial part of which is coated with a wire spiral 31 that enables X-ray visibility during intervention in the interior of the organism, i.e. inside blood-filled blood vessels and the heart. Figures 3 and 4 show the pusher 40 of the surgical thread 30 inside the blood vessels and the heart composed of a narrow elongated metal cannula 40 with a central channel that ends with openings 41 and 42 and a starting part 43 that releases the thread when pulled back (in figure 3) or tightens the thread when pushed forward (in figure 4) by tensioner 45. In order for the thread to be transported in remote locations of blood vessels or the heart via the catheter, it is necessary to previously insert the thread into a narrow catheter, which is achieved with the aid shown in Figure 5A and 5B. A metal cannula (metal narrow tube) 50 with a narrow central channel that ends with an opening 51 and begins with a part 53 on which a clamp 54 is mounted allows the passage of a thin wire 55 through the central channel. At the beginning of the wire there is a metal thickening of the ball 56, which is smaller than the diameter of the central channel and can be tightly inserted through the opening 51. In order to insert the surgical thread into the catheter 4003, which is located outside the body, the metal cannula 50 is placed through the catheter 4003 or through the pusher 40, and then the end of the thread located outside the body (where the initial part of the thread is placed inside the blood vessels or heart) is inserted through the initial opening 51 and the wire 55 is pulled back so that the ball 56 at the beginning of the wire presses the end of the surgical thread 30 and the position of the wire is fixed with the tensioner 54. The whole instrument is pulled back keeping the catheter 4003 in the same place (immobilized) whereby the thread 30 is drawn into the catheter together with the entire instrument-cannula 50. When the end of the thread is pulled out of the catheter (or pusher) the tensioner 54 is unscrewed and the instrument 50 is pulled out leaving the thread 30 inside the catheter 4003 or inside the catheter-thread 40. In Figure 6A B, and C show variants of catheter-type surgical knot pushers and knot tying. Figure 6A shows a node pusher consisting of an elongated plastic tube (medical catheter type) 60 with a central channel (lumen) 64 that begins with an opening 61 and ends on the side wall with an opening 62. The pusher can also be made of a metal cannula 601 at the beginning of which a plastic conical part 603 is mounted with a central channel 603 passing from the initial opening 604 along a certain length of the inside of the instrument and exits to the side wall 62, which is shown in Figure 6B. The pushing (pushing) of the surgical knot made outside the body with the ends of the threads 30 and 30', the initial parts of which inside the blood vessels and/or the heart have already been brought to the places where the two parts of the tissue should be pressed against each other is shown in Fig. 6C: With the pulled ends of the threads 30 and 30', a simple ladder knot is made, and the end of the thread 30 is passed through the central lumen 603, pushed 601 through the lateral opening 602. Holding the end of the thread 30 with a taut pusher 601, the vessel is drawn into the blood (usually through the introducer catheter) pushing a single-degree knot in front of it, while at the same time the end of the thread 30' is loosened to allow the knot to travel through narrow spaces to the target site as shown in Figure 6C. Figure 7 A and B shows a thin elongated stabilization tube-hose (tube) 70 made of a soft thin elastic compressible material preferably medical silicone with a central lumen from the initial opening 71 to the end opening 72. In one variant (not shown) this tube has a side opening at a distance of up to 10 mm from the end opening 72. This tube is intended to support the thread the retainer-tensioner structure inside the heart, during which it is pulled over the thread of the tensioner, which replaces the surgical knot inside the heart, which is described in more detail in the following text. Figures 8A, B, C, and D show the modalities of the implant - pads (pledget) on the mitral leaflets that are tensioned with artificial cords during the procedure. The implant shown in Figure 8A consists of a small oval-shaped part 81 which is introduced through the catheter and is located between the ends of the tensioner and the mitral leaf from the atrial side, while the other smaller part 812 of similar properties is intended for tamponing (support) between the ventricular (ventricular) surface of the mitral leaves and other elements of the tension artificial set. Another variant of the implant on the mitral leaflets can be seen in Fig. 8B: the part 82 located on the atrial surface of the mitral leaf consists of two arms 820 and a central part 821 which has a central channel 8211 that serves for the passage of the guide wire through which the element is introduced to the target place, while the part 822 is intended for the support of the implant from the ventricular side. The third variant of the implant 83 supporting the mitral leaflets is seen in Fig. 8C and consists of a half-moon-shaped pad which in the central part has an integrated implantation thread (made preferably of ePTFE) 831 which continues in the extension to a spiral wire construction similar to the known "stent" (X-ray visible) 832 and which can be easily connected by mechanical pressure to the end of the second thread (voilje) 30 due from the organism. The fourth variant of the mitral support implant 84 is shown in Figure 8D. The implant has integrated two ends of the implantation threads 841 on its end parts, the threads continue on 2 spiral wires 842 each formed so that it can be connected to the end of the guide thread 30. Figure 9 shows - the occluder-stopper 90 of the entrance opening on the free wall of the heart muscle. It consists of a central part of a spongy mass made of medical polymers (polyurethane or Ivalon-polyvinylalcohol) reinforced with a network of thin threads 903, solid end parts - half-moon and/or hemispherical parts 901 and 902. On the larger element 902, thread 9021 is integrated, which is formed into a knot (the so-called modified "bowline", Rettungsknoten" Pasnjak" knot). 90212 with additional spiral loops 90211 that form a prepared thread bodice 30 that passes through the central portion of the occluder implant 90. The maneuver to retract, hold the mitral leaflets 1114 and 1115 in a closed and/or semi-closed position to facilitate needle puncture of the valve is shown in Figure 10 A. Self-opening instrument 1021 (umbrella described earlier) is introduced through the catheter 400 from the vein through the left atrium 1112 to the left ventricle 1111a via a thin guide wire 1014, which is led out of the body through the artery via the aorta at the other end. By pushing the element 1012 out of the catheter, it expands, and its withdrawal and thereby the tightening of the mitral leaflets is achieved by pulling the guide wire 1014 and the cone 1013 mounted on it towards the left atrium 1112. Alternatively, the other end of the guide wire of this mitral leaflet tensioner can be carried out of the body directly through the top of the left ventricle into which the introducer catheter 4001 is introduced. Figure 10 B shows an alternative the construction of the mitral leaf tensioner 1003 with its part 100 that self-extends upon exiting the catheter, and by pushing its end 1002 through the introducer 4001, the tensioner does not allow the mitral leaf 1114 or 1115 to open. Alternatively, valve puncture can be performed during a short acceleration of the heart rhythm by electrostimulation of the heart with a temporary pacemaker, which keeps the valves in a predominantly closed state. The beginning of the new procedure by which the invention is applied is shown in Figure 11: A set for direct puncture of the left ventricle consisting of a needle 11 protected by a catheter dilator type 21, the catheter is introduced through the intercostal space through the muscle of the apex of the left ventricle 1111 through the posterior mitral leaflet 1115 into the left atrium 1112 under the control of ultrasound and Roetgen, previously a catheter 400 is placed in the left atrium, the so-called introducer transseptally. Figure 12 shows the scheme of introducing the guide wire 30 with the spiral wire 31 through the dilator catheter 21 to the left atrium 1112a through the posterior mitral leaflet 1115 which was previously perforated - punctured. Pushing the guide thread 30 through the catheter dilator 30 is enabled by the thread conveyor 40 (pictures 3 and 4). Through the introduction catheter 400, which is placed from the right inguinal vein through the right atrium through the septum between the atria (known routine transseptal catheterization), a thin catheter 500 with a loop (snare) 501 is introduced into the left atrium and the wire end 31 of the guide wire 30 is captured with it, which is shown in Figure 13. The captured end of the guide wire is pulled out through the catheter 400 outside the body through right inguinal vein. Figure 14 shows the scheme of implantation of implants 82 and 822 over the guide thread 30 which is formed in the rail from entering through the tip of the left ventricle 1111 through the posterior mitral leaf 1115 into the left atrium 1112 through the transseptal catheter 400 to the exit into the inguinal vein; the implant 82 is tied to the removed end of the guide thread 30 through the inguinal vein, and the thread 30 is pulled back into the left atrium 1112 and further tightened so that the pledget implant rests firmly on the posterior mitral leaf 1115; through the inlet catheter at the top of the left ventricle and over the guide wire 30, the ventricular part of the implant 822 is inserted with the help of the catheter 21 and is tightened to join with the part 82, squeezing the tissue of the mitral leaf between them, the central element 821 of the implant 82 is serrated so that passing through the central element of the implant 822 does not allow its separation. Over the guide wire 30 and through the introducer catheter at the top of the left ventricle, the occluder 90 of the entrance opening of the heart muscle is introduced; the guide thread 30 is directly passed through the made knot integrated on the outer part of the closure. The closure 90 is made of a spongy central part (Polyvinylalcohol-Ivalon or Polyurethane) which is compressible so that it can be easily introduced as a whole through the introducer catheter and over the guide 30. By tightening the end of the guide 30 while simultaneously controlling the movement of the mitral leaflets with ultrasound from the esophagus (transesophageal echo-TEE), the systolic amplitudes of the closing movement are brought to the desired level and manually (if it is done under control) eye) by tightening the knot 9021x30 the position is fixed. The thread and knot tightening maneuver on the outer surface of the heart can also be done without direct manual access using the instrument 50, the initial part of the guide thread is pulled into the catheter and a one-stage knot is made extracorporeally around the thread integrated on the outer part of the entrance hole closure, and the knot is transported by catheters with knot pushers 60, 601. The free ends of the knot threads are cut off directly with scissors if the procedure is performed under eye control or scissor-type catheter shown below through the catheter approach. A variant of the implantation of an artificial mitral valve tensioner is shown in Figure 15. The implant pad (pledget) 83 with integrated implantation thread 831 is introduced through the transseptal catheter introducer 400. After bringing the pad implant to the surface of the target valve, which is achieved by pulling the guide thread 30 (which is connected extracorporeally by means of a wire spiral 832 to the integrated thread 831 on the implant pad - (Fig. 8C) the guide thread 30 is removed as well as the wire segment 832 of the implantation thread so that the implantation thread 831 remains as an extension of the guide pad through the left ventricle 1111 to the apex of the heart and to the closure of the entrance opening 90.

A narrow stabilizing tube (tube) 70 is pulled over the implantation thread, which is pushed by the catheter pulled over the thread with the instrument 50 so that it exerts slight pressure on the chamber side of the anterior mitral leaflet 1114 and its weakened part 11141. By pulling the implantation thread 831, the pledget 83 pulls the excessively mobile part of the anterior leaflet 11141 towards the chamber and in the desired position, the bandage for the occluder 90 knot 9021x831 performs the function of artificial chordae tendineae. An additional variant of mitral leaflet tightening is shown in Figure 16. Consecutively through the same introducing catheter at the top of the left ventricle 4001, a part of the mitral leaflet is pierced (perforated) in two places and two rails are made - guides 30 and 30' from the entrance at the top of the left ventricle through, in the case shown, the anterior mitral leaflet 1114 to the left atrium 1112 through the transseptal catheter introducer 400 to the exit through inguinal vein. At the end of these two guide wires, the implant pad 84 is connected and pulled back until the contact of the implant 84 with the atrial surface of the part of the mitral leaf 11141; After bringing the pads by pulling the guide thread 30 which is connected extracorporeally to the wire coil 842 (Figure 8D) and the integrated implantation thread 841 on the implant, the guide thread 30 and the wire coupler 842 on the integration thread are removed so that the implantation thread 841 remains as an extension of the guide of the pad implant through the left ventricle 1111 to the top of the heart and to the closure of the entrance opening 90 and further outside the body as a free end.

The stabilizing tube 70 is pulled over both integrated implantation threads 841 and pushed with the catheter towards the ventricular surface of the mitral leaf 1114 so that it tightens both threads starting from the silicone pad 84 on the surface of the valve, thus performing the function of tightening the system without creating a knot inside the heart. Both threads 841 are passed through the occluder 90 of the entry site on the left ventricle. By further pulling the implant threads, the anterior mitral leaf 1114, i.e. its excessively mobile part 11141, is tightened to the desired level in which during the ventricular contraction it does not move towards the atrium, and in that position both ends of the threads are tied to the outer element of the inlet opening closure 90 which was introduced through the introducer catheter 4001 and through both implantations on the implant integrated threads 841 (Fig. 17 and 17B). Tightening of the central parts of both mitral leaflets at the same time is shown in Figure 18. Two rails of the guide thread are traced from the top of the left ventricle through the introducer catheter 4001 through the left ventricle 1111 through the central part of the free edges of the posterior 1115 and anterior 1114 of the mitral leaflet through the left atrium 1112 through the transseptal introducer catheter 400 to the inguinal vein; on the ends of the pulled guide threads 30 and 30', an implant pad 84 is mounted outside the body, and the guide threads are pulled back towards the left atrium; Figure 19 shows the tying of a knot on the outer surface of the heart after installing a tension device on the mitral valve using a catheter-based pusher (60,601) of individually made knots outside the body and lowered individually through the introducer catheter (4001) to the target site, one end of the withdrawn thread 841 is held taut and an individual knot is made with the other end of the thread around the first thread and lowered by the pusher to the target site in a typical example through the intercostal space to the top of the left ventricle. Insertion of the ends of the withdrawn thread into the catheter or the catheter-based pusher 601 or 60 is performed using the instrument 50 as shown in S1.5A and 5B.

Figure 20 shows cutting the ends of the knot made with a catheter-based "cutter"

(cutter) 102 on the surface of the heart (in a typical example at the top of the left ventricle) through the introducer catheter (4001) introduced through the intercostal spaces to the top of the left ventricle. A detailed description of the cutter-based cutter 102 can be found in patent application 209/04 dated March 9, 2004 by the same inventor.

Figure 21 shows the tightening of the central part of both mitral valves 1115 and 1114 with a pledget 84 on the atrial surface of the mitral leaflets by implanting integrated guide threads 841 that are passed from the pledget through both mitral leaflets through the entrance opening in the top of the left ventricle 1111a over which the stabilizing tube 70 is pulled to stabilize the pledget on the valves instead knot by clamping both guide threads and the closure of the entrance of the left ventricle 90. The set composed of the implant pad 84 and the implant of integrated threads 841x841 is stabilized inside the heart with a sluha 70 and tightened - tied with a knot for the outer element 9021 of the closure of the entrance to the left ventricle 90. Tightening of both central segments of both mitral leaflets with pads (pledget) from the atrial side of the mitral leaflets with a pad 81 and from the ventricular surface additionally with a pad 812 over two guides 30 and 30' stabilized by a tube (tube) 70 and attached to the outer element 9021 of the occluder-closer 90 of the entry site on the free wall of the cardiac chamber part of the muscle shown in Figure 22.

It goes without saying that the listed variants of the implant pads 81, 82, 83, 84 are only the simplest prototypes that schematically show the possibility of applying the device system. Implant pads can have a different shape, dimensions and consistency adapted to the tissue of the heart valve, for example, the implant pad can have the form of an expanded flattened strip of the same material as the implantation threads to which it continues at its ends (not shown in the pictures). The implant pad should have a small thickness and a smooth surface so as not to create turbulence in the blood that flows over the valve. The surface covered by the implant pad should be sufficient so that by tightening it, it can pull part of the weakened valve leaf. It is possible to install more than one pad implant on one or both valves. It is also possible to construct implant pads with 3 or more implant threads with the same installation method. It is further understood that the wire coil (like stent) implantation wire connector 832 and 842 with the guide wire 30 can be replaced with any type of mechanical connector (such as n.p type with a micro-threading mechanism) that would connect the ends of these two wires in such a small diameter that the connector can be transported through the lumen of the cardiovascular catheter. It is further understood that the implants are made of biocompatible polymers, preferably "expanded polytetrafluorourethane e-PTFE or silicone or any biocompatible polymer. It is further understood that the shown method of assembling the individual elements of the system into a whole implant inside the heart is only a simple representation of the technical aspect of completing the functional unit.

In another variant (not shown in the pictures), the implant pad can be placed on any side of the valve, and the implant threads or guides can pass through the valve with one arm and through the opening between the valve leaves with the other, and through the same entrance opening outside the heart and outside the body, with fixation to the target valve with a stabilizing tube as described. The stabilization hose 70 can have a side opening through which one arm of the tensioner thread can be passed, whereby a part of the stabilization hose can serve as a valve pad (not shown in the pictures).

Claims (9)

1. A system of implants that enable the limitation of the movement amplitudes of parts or as a whole of one or more leaflets of the heart valves in certain phases of cardiac activity, characterized by the fact that it is made of three separate elemental polymeric implants of the tissue pad type (83-84) with integrated threads (831), (841); occluder (90) of the entrance site on the free wall of the heart muscle and elastic polymer stabilization hose (70). 2. The implant according to claim 1, characterized by the fact that it consists of a polymer base (83) with an integrated thread (831) at the end of which an integrated adapter-coupling is presented in one variant but not exclusively as a wire spiral (832) of small outer diameter (<lmm) that allows passage through the channel-lumen of a cardiovascular catheter, similar to a vascular "stent", with a free internal lumen in which can be placed at the end of the pulled guide thread (30), which can be strengthened by external mechanical pressure so that the thread of the washer (831) is firmly connected to the guide thread (30). 3. The implant according to claim 2, characterized by the fact that it has two integrated threads (841) at the ends of which there are adapted connectors (842) for connection with the ends of two threads or guide wires (30). 4. The tissue polymer pad (82) indicated by this consists of two elements (82) and (822) behind the toothed central articulation mechanism (821), one of which is located on one surface of the valve and the other on the other surface of the valve, both placed over the end of the guide rail (30) that passes through the central channel (8211), both elements individually on one and the other side of the valve 5. The implant according to claim 1, indicated by this, consists of a closure of the entrance opening on the free wall of the heart muscle (90), which consists of a central segment (903) preferably, but not exclusively, made of a resilient (self-healing) sponge made of a biocompatible polymer (polyurethane or polyvinyl alcohol - Ivalon) reinforced with a network of thin surgical sutures, and two end segments, a smaller inner one (inside the heart). (901) of hemispherical shape preferably but not exclusively of silicone material and an outer (902) of the same shape and material only of larger dimensions with an integrated thread (9021) and a preformed "loop" knot (90211-90212) ready to receive one or more ends of the guide thread (30) or implantable integrated thread (831) and (841) valve leaflet tensioners which pass through the valve (or through the valve with one arm and the opening between the valves with the other arm), through the valve pads (82), (83), (84), through the stabilization tube (70) between the valve and the heart muscle, through the inner middle and outer segment of the closure (902) to which it is tied. 6. The implant according to claim 1 is indicated by the fact that it is made of an elastic polymer thin-walled compressible hose (70) whose length, inner channel, wall thickness and outer circumference are adapted to the threads of the implant according to claims 1, 2, and 3 or to the guide thread (30) and further adapted to the dimensions inside the cardiac structures between the closures of the entrance opening according to claim 5 on the free wall of the heart muscle and the leaflet of the heart valve on which the implant pad according to claim 2 and 3 is located. 7. The transport guide-rail through the heart and blood vessels (30) indicated by time is made of two parts: one of medical thread (such as nylon, prolene) of arbitrary length, on one end of which there is a Roentgen-visible part made of easily bendable medical wire (31) and of small thickness that allows the placement of ordinary cardiovascular catheters (< 1 mm) of arbitrary length to form a transport rails inside the heart and blood vessels and through cardiovascular catheters. 8. The catheter guide wire transporter, indicated by the fact that it consists of an element of the type of metallic tubular canula (40), with a small outer diameter so that it can be placed in the internal channel (lumen) of the cardiovascular catheter, through whose tip (41) the beginning of the thread (30) is inserted, which is passed through the entire length of the cannula, and is pulled out through the initial entrance of the cannula, on which there is an element (45) with which the thread in the interior of the central channel cannulae can be fixed or released; in the fixed state, by pushing the cannula, the guide thread located inside the cannula is also pushed; when the thread tensioner is unscrewed, i.e. when the thread is freed from fixation, the cannula can be pulled back for a certain length, leaving the guide thread at the reached point; by repeating these moves, the thread can be transported through the cardiovascular catheter to remote locations within the body. 9. The method of assembling the individual elements of the implant system according to claim 1 into a functional unit inside the organism, indicated by first installing one or more transport guides according to claim 7 from the entry point on the heart through the target valve and to the exit from the heart, through another opening or back through the same entrance opening, and outside the body, so that the beginning and end of the guide is outside the body and the rest of the length of the guide is inside the body on the described path, with the help of a conveyor guide according to the request 8; mounting of the implant according to claim 2 and 3 on the end of the guide taken outside the body; transporting the implant according to claim 2 and 3 to the target valve by pulling the guide backward; cutting off the coupling adapter (832, 842); pulling the stabilization hose according to claim 6 over the guide and/or over the threads (831) or (841) and placing it between the entrance opening on the free wall of the heart muscle and the valve on which the implant is placed according to claims 2 and 3; pulling (through the mentioned threads and guides) the closure of the entrance opening on the free part of the heart muscle according to claim 5; dosed and controlled tightening and tying of threads (831) or (841) or (30) to the outer part of the closure according to claim 5.