WO2007100268A2

WO2007100268A2 - Catheter based mitral valve repair method and apparatus

Info

Publication number: WO2007100268A2
Application number: PCT/RS2007/000006
Authority: WO
Inventors: Uros Babic
Original assignee: Uros Babic
Priority date: 2006-03-02
Filing date: 2007-02-26
Publication date: 2007-09-07
Also published as: WO2007100268A3; WO2007100268B1; EP2023822A2; RS20060147A

Abstract

Method and devices including novel suture composition, catheter type suture transporters, pushers -and tying instruments, implant-pledget for anchoring onto the mitral leaflet, myocardial free wall entry site occluder, and technique for catheter based treatment of mitral regurgitation are presented. In one embodiment, a leaflet tension apparatus is implanted to adjust the systolic leaflet amplitude excursion. A continuous guiding suture track is created from the direct left ventricular puncture site through one or two puncture sites of the leaflet (1114) via the transseptal catheter and femoral vein; a pledget-implant (84) is apposed onto the exteriorized 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 myocardial wall (1113) covering the implant's integrated sutures (841) which are directed through the free myocardial wall oclluder (90) and secured to its epicardial segment by an adjustable knot (9021x841) so as to keep the leaflet at the wanted distance during systole whilst the valve opening remains unhindered.

Description

Catheter based mitral valve repair method and apparatus

Cross reference to related application

In this application an instrument is described as a part of the method that is reported in the patent application YU 209/04 filled March 09, 2004 by the same inventor the entirety of which is included by reference herein* .

Field of the invention

The invention belongs to broad field of medicine and more specific it belongs to field of minimal invasive cardiac surgery and interventional cardiology and relates to reconstruction of insufficient mitral valve on beating heart by catheter based technique. According to international patent classification (MKP, IPC) the specification is A61B17/00, A61B17/068, and A61B17/122.

The invention contributes to armament of treatment of mitral insufficiency due to excessive excursions of one or both cups on beating hear by catheter based -or minimal invasive technique under fluoroscopy and/or ultrasound guidance.

Background

The human heart consists of two atria right and left separated by the atrial septal wall and two ventricles separated by interventricular septal wall. Between atria and ventricles there are valves that open and close in order to allow blood forward transportation. Between the right atrium (RA) and right ventricle (RV) there is tricuspid valve and between the left atrium (LA) and the left ventricle (LV) there is mitral valve. Ventricles forward the blood to the lung and to the whole body through the pulmonary artery and aorta respectively. Between the RV and pulmonary artery there is pulmonary valve and between the LV and the aorta there is aortic valve. Mitral and tricuspid valves are connected via thin structures called chordae tendineae to papillary muscles and myocardial wall. During closure, these chordae keep the valves at physiological distance avoiding overextension of the cusps backwards that would lead to valve insufficiency. Valve dysfunction can be manifested as stenosis (disturbed opening) or insufficiency (incomplete closure). Left sided valves (aortic and mitral) are prone to malfunction because the pressure developed by left heart is higher than the right-sided. Mitral stenosis is treated usually by dilatation with a balloon catheter, or mechanically by instruments (closed surgical procedure) or by open commissurotomy or the valve is replaced. Conventional treatment of mitral insufficiency comprises a valve replacement or valve repair during open cardiac surgery. Open surgical mitral valve repair comprises of partial resection of diseased cusps, shortening or elongation or transposition or implantation of an artificial chordae tendineae and remodeling of papillary muscles and mitral annulus. Recently the so called "edge to edge" technique is being used (J Thorac Cardiovasc Surg 2001; 122:674-81: single stitch is applied at the middle of both cusps; this keeps both cusps together during whole cardiac cycles). The double orifice mitral opening does not affect the inflow but improves significantly the valve closing function. More recently there are attempts to treat mitral insufficiency by catheter based and minimal invasive techniques. US patent No. 200514982 describes catheter based implantation of mitral annulus. This technique can be helpful in cases where the annular dilatation is prominent causal factor but is not useful when mitral cusps are hypermobile or when the chordae tendineae are elongated. Patent WO No. 99/00059 describes technique of mitral insufficiency treatment by clips method: Using initially the approach from the left ventricular apex a metallic clips is introduced and placed to grasp the middle of both cusps- which imitates edge to edge technique. The method of capturing the middle of cusps on beating heart is described in Patent AU 2004229028 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). US Pat. No. 6626930 describes integrated methods reported in WO 99/00059 and AU2004229028 regarding the application of minimal invasive catheter based techniques using clips. After experimental studies this. technique has been applied on humaris as a preliminary clinical study with promising results (Feldman T, Wasserman HS, Hermann 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 a treatment of mitral insufficiency by catheter technique without thoracothomy. Left atrial access with large transseptal sheath (24Fr) is needed for this technique. This size might compromise the femoral venous access site. Cusps capture technique is complex and metallic clips are relatively large for the LV cavity. There is potentiality for dislodgement of the clips (already reported). The thrombogenicity of the clips is to be considered and the metallic implant might lead to blood components damage. There is possibility of myocardial tissue damage by metallic clips during dynamic heart activity.

Summary of the invention

The aim of the present invention is development of technique and means for minimal invasive catheter intervention on insufficient mitral valve under beating heart environment which would enable a control of excursion amplitude of one or both mitral cusps.

Yet another object of this invention is the accomplishment of the procedure by catheter based implantation of chordae tendineae without need for fastening the intracardiac structure with a knot. Objective of this invention is further to apply technique which could enable accomplishment of the procedure per catheters of low profiles. Yet another aim of the invention is to provide means for intracardiac implantation of less traumatic materials with characteristics similar to natural structures of the mitral valve leaflets like polymers polyesters, e.g. silicon, nylon, PTFE . Visual control of the procedure would be provided by fluoroscopy and ultrasound that enable visibility in cardiac chambers filled with blood.

The mentioned objectives can be accomplished by following means and technique : Access to left ventricular apex by direct transthoracic puncture under fluoroscopy and ultrasound or minimal invasive access by thoracoscope under direct visual control; Placement of a sheath or port access trough the intercostals room to the pericardial space can be done as reported in US pat. No 2003114796, WO2004028613, WO03066147. An introducer sheath of small sizes (6,-7 Fr) is introduced into left ventricle by Seldinger technique (technique for introduction of catheters into a vessel by inserting a needle a guiding wire through the needle and over the wire a catheter type instrument). Direct left ventricular puncture has been applied for diagnostic purposes (Ommen SR,Higano ST, Nishimura RA,Holmes DR Jr. Summary of the Mayo Clinic experience with direct left ventricular puncture. Cathet Cardiovsc Diagn 1988 Jun; 44(2): 175-9); under transesophageal echocardiography (TEE) an appropriately sized and shaped needle covered with small dilatator is introduced through the introducer sheath and the mitral cusp is punctured- perforated at the wanted site and the small dilator is advanced over the needle from the LV cavity through the puncture site of the mitral cusp to the left atrium. This step can be done either during the spontaneous cardiac cycles (in phase of mitral valve closure) or utilizing a valve manipulator that holds the cusp in closed position. As mitral valve manipulator the umbrella introduced over the continuous wire track arranged from the femoral vein transseptally to the left atrium , left ventricle and out of the body through the femoral artery as reported ( 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,Babic UU,Hausdorf G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS (multiinstitutional European trial) Am J Cardiol 1998 Decl;82(ll): 1405-13). Alternatively, the mitral cusps can be kept in closed position by additional type of manipulator as described bellow. After leaflet puncture the needle is withdrawn and a nylon suture with wired flexible tip (original manufacture of suture length for visibility under fluoroscopy) is advanced from the left ventricle across the leaflet puncture site to the left atrium using a specially manufactured suture pusher. An 8Fr transseptal sheath is introduced by conventional technique from the femoral vein into left atrium. A lassos catheter ( e.g. Lassos Osypka GMBH Germany- reported in: Sievert H,Babic UU, Hausdorf G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS ( multiinstitutional Europen trial) Am_. J Cardiol 1998 Decl;82(.l l): 1405-13) is introduced through the transseptal sheath into the left atrium. Under fluoroscopy the distal wired tip of the nylon suture within the left atrium is snared by lassos and exteriorized through the femoral vein. A silicon implant (pledget) is mounted onto the exteriorized end of the nylon suture length and advanced through the transseptal sheath to the left atrium to contact the mitral cusp by retracting the suture length. Dilatator is withdrawn over the nylon suture back from the left heart through the introducer sheath. Over proximal end of the nylon suture length (situated extracardially in front of left ventricular access) a silicon tube of appropriate size (similar to that used for permanent pacemaker lead covering) and with the length equal or minimally longer than the distance between the mitral leaflet in closed position and the inner left ventricular wall is advanced. Silicon tube is advanced over the nylon suture length by a dilator such that the distal tube end contacts the mitral leaflet at the site where the nylon suture length traverses the leaflet, while the proximal end of the tube contacts the inner side of the LV myocardium at the site of access by introducer sheath. Pulling the nylon suture length (that is intracardialy connected to the silicon implant situated at the left atrial surface of the leaflet) the implant is being pulled and stabilized against the distal end of the silicon tube that contacts the ventricular surface of the leaflet guided by the suture length. Since the nylon suture length and silicon tube are flexible structure opening of the mitral valve is not affected. LV access site is closed with an original occluder. Occluder made of silicon parts on both extremities and a central part made of polyurethane or polyvinilalcohol sponge is advanced over the proximal remaining end of the nylon suture length through the sheath into the left ventricular wall compressing thereby the silicon tube situated between the occluder and the puncture site of the mitral leaflet. Pulling the remaining external end of the suture nylon length the silicon implant on the left atrial side of the mitral leaflet is also being pulled and the silicon tube situated between the leaflet and the free wall occluder is compressed in which way the amplitude of leaflet excursions is adjusted to a wanted level as controlled by ultrasound. When the wanted amplitude of leaflet excursion (during systole) is achieved the suture nylon end is tightened to external part of myocardial free wall occluder. The free wall occluder comprises a preformed knot suture for securing the nylon suture length using knot pushers. The free ends of the knotted sutures are cut off by a catheter based cutter leaving silicon implant connected to the occluder at the left ventricular apex by nylon suture covered with a silicon tube situated between the inner surface of the left ventricular apex and the ventricular surface of the mitral leaflet over the nylon suture.

The described technique is a simple typical version. Means and technique described can be used in other locations and other valves and other cardiac and no cardiac locations. Instead of nylon suture any medical grade suture can be utilized. The silicon implant that contacts the leaflet from the left atrial surface can be connected and stabilized with 2 or more suture lengths which . gives the morphology of arborization (like natural chordae tendineae) and after leaflet puncture et 2 or more sites. . . , This technique might be applied to both leaflet simultaneously whereby after individual puncture of both leaflets, anterior an posterior, silicon implant is stabilized and fastened to middle portion of both leaflets by 2 or more suture nylon lengths covered by a single silicon tube from the ventricular side which functions as a knot and approximates the middles of both leaflets like Alfieri procedure without the need of making a surgical intracardiac knot on beating heart.

Brief description of the figures

Fig.1 shows long view of assembly for transthoracic puncture of left ventricle and mitral leaflet.

Fig.2 shows long view of originally constructed surgical suture material for intracardiac application with radiopaque tip for fluoroscopic visualization.

Fig.3 is a long view of catheter type suture transporter for use within vasculature and catheters in position of withdrawing the instrument whilst leaving the suture to be transported in place.

Fig.4 shows the suture transporters of fig 3 whilst pushing the suture within a catheter room.

Fig.5 shows long view of instrument for insertion of a suture into a catheter type instrument in open position.

Fig.5B shows instrument from Fig5 in function of suture fixation within a catheter and made ready for pulling the suture into the catheter lumen.

Fig.βA shows catheter type knot pusher for transportation of an extracorporeally created knot towards distant vascular and cardiac locations.

Fig.6B shows another version of instrument from that presented in Fig.όA.

Fig.βC shows catheter type knot pusher with prepared suture knot.

Fig.7 shows silicon tube for support function of artificial tension apparatus of the mitral leaflets.

Fig.8 A shows schema of implant (pledget) on mitral leaflet from left atrial and ventricular side.

Fig.8B shows the implant from Fig.8 A with modified parts leaning individually onto the atrial surface of leaflet and onto the leaflet from the ventricular side.

Fig.8C shows a variant of implants showed in Fig.8A and B with the part that leans onto the atrial leaflet surface comprising integrated suture length with a wired spiral for coupling with the end of a guiding suture.

Fig.8D shows the variant shown in. Fig 8C but with integrated double suture length and with wired spirals for coupling with 2 guiding suture ends.

Fig.9 shows free myocardial wall occluder

Fig.10 A shows method of immobilization of the mitral leaflet in semi-or closed position for leaflet puncture.

Fig.1OB shows another variant of method shown in Fig.1OA. Fig.l 1. shows schematic view of the left heart with atrium and ventricle and the mitral valve between them. Puncture of the posterior mitral leaflet with elongated solid needle covered with a catheter type dilator of small diameter made of polymer.

Fig.12. Shows insertion of the special guiding suture with spiral wired tip through a tubular access from outer myocardial wall to the left ventricle through the posterior mitral leaflet into the left atrium.

Fig.13. shows catching of the inserted guiding suture length within the left atrium with a lassos catheter.

Fig.14 shows schema of tension of the posterior mitral leaflet with the new technique.

Fig.15. shows schema of tension of the anterior mitral leaflet with the new technique with the use of implant of Fig.8C.

Fig.16 shows the creation of double guiding suture track for tension of prolapsed anterior leaflet.

Fig.17 and 17B show the procedure of tension of the anterior leaflet using the implant from Fig.8D.

Fig 18. Shows schema of creation of double guiding suture track through both

,anterior and posterior, leaflets for their approximation during systole.

Fig.19. shows catheter based tying a knot by catheter knot pusher on the outer myocardial surface through a catheter type access.

Fig.20. shows cutting off of the free ends of a knot by catheter type cutter introduced through a catheter type access.

Fig.21 shows the procedure that limits the functional mobility of the middle part of the leaflets.

Fig.22 shows the procedure shown in Fig 21 with reinforced limitation of closing mobility of middle parts of both leaflets by added left ventricular implant.

Detailed description of the invention

Application of technique in this invention, necessitates utilization of many tools - instruments of cardiovascular catheter type some of which are well known in everyday practice and some of which are new constructions. New instruments are depicted in Fig 1-10 and their application and procedure details are depicted in Fig.l 1-22.

Fig.1 illustrates long view of a kit for thransthoracic direct left ventricular puncture through intercostals space. The kit consist of needle 11 without lumen with sharp distal end 12 and stump proximal end 13 made of medical grade stainless steel 20-25 cm long and 1 mm thick. The needle is covered with a plastic catheter (angiographic dilator) 21 with central lumen that ends as opening 22 and 23 through which the needle 11 is introduced. Fig.2 illustrates modified surgical suture length 30 with wired spiral tip 31 that enables fluoroscopical visualization during procedure within the body. Fig.3 and 4 illustrate a pusher 40 of surgical suture 30 within vasculature and heart composed of a narrow elongated metal cannula-catheter 40 with central channel that ends as openings 41 . and 42 and proximal part 43 that releases the suture during instrument withdrawal (fig.3) or fixate the suture during instrument advancement (fig.4) with fastener 45. In order to make transportation of suture length into distant intravascular and intracardiac locations by catheters it is necessary to insert the suture into the narrow lumen of catheters which is achieved by means depicted in fig 5 a and 5b. Metal cannula 50 with narrow central lumen which ends with opening 51 with a proximal part 53 with integrated fastener 54 that enables passage of a thin wire 55 through the central lumen. The wire tip is formed into a ball 56 with the diameter slightly smaller than the central lumen of the cannula which enables the passage through the opening 51. To insert a suture end extracorporeally into a cardiovascular catheter 4003 the metal cannula 50 is placed into the catheter 4003 or into a pusher 40 and the exteriorized suture end (one end is within the vasculature or heart) is inserted into the opening 51 and the wire 55 is retracted such that the ball 56 on the wire compresses the suture end 30 and the wire position is fixated with the fastener 54. The whole instrument is retracted keeping the catheter 4003 immobilized whereby the suture 30 is inserted together with the instrument 50. After the suture end was traversed the total length of the catheter or pusher the fastener 54 is released and the instrument 50 is removed leaving the suture length within the catheter 4003 lumen or within a pusher catheter 40. Fig;6A B and C illustrate some variants of knot pushers and knot tying means. Fig 6A illustrates knot pusher comprising of an elongated catheter type member 60 with a central channel 64 that begins with an opening 61 and ends as a lateral opening 62. A pusher may be made also of metal cannula 601 on which distal end a piece of plastic of conical catheter dilator like part 603 is apposed. Its central lumen begins from the distal opening 604 and ends after certain length on lateral wall as opening 62 as illustrated with Fig.6B. Advancement of a knot made extra corporeally from sutures' ends 30 and 30' (which second ends are placed within the vasculature or are intracardially situated at target tissue to be sutured) is illustrated in fig. 6C. Exteriorized suture ends 30 and 30' are knotted with a simple one step knot and the end of the suture length 30 is inserted into the central channel 603 of pusher 601 and exeteriorized through the lateral opening 602. Keeping the end of the suture 30 slightly under tension the pusher 601 is introduced into the vasculature (usually through a sheath) whereby the one step knot is being advanced forward ; releasing the suture end 30 such that allows the one step knot transportation the knot is advanced through narrow space to reach the target location as illustrated in Fig.6C. Fig.7 illustrates thin elongated tube 70 made preferable of silicon with central lumen from opening 71 to 72. This tube is used for supporting the suture length over which is advanced as described in details in further text. Figure 8A, B, C, and D illustrate modalities of implants (pledgets) to be implanted onto the mitral leaflet and fastened with tension sutures. Fig 8 A illustrates the implant as a small oval silicon part 81 that is introduced through a catheter and contacts the atrial surface of the leaflet held by the tension suture while the second smaller part 812 of similar characteristics is placed onto the ventricular surface of the leaflet. Another variant of implant is shown inFig.8B; part that leans onto the atrial leaflet surface 82 has 2 arms 820 and a central part 821 with a central channel 8211 for passage of the guiding suture while the part 822 is aimed for supporting the implant from the ventricular side. Third variant of implant 83 is seen in Fig. 8C. It comprises a semi lunar silicon part with centrally integrated suture length 831 that ends as a wired spiral (radiopaque) 832 aimed to be connected with the end of an exteriorized guiding suture 30. Fourth implant variant 84 is shown in Fig. 8D. Semi lunar silicon implant has two integrated sutures lengths 841 with 2 wired spirals 842 aimed to be connected to the guiding suture ends 30. Fig.9 illustrates the free myocardial wall occluder 90. It consists of a central part 903 made of sponge of medical polymer (polyurethane or polyvinilalcohol) reinforced with a suture mash and distal 901 and proximal 902 semilunar or semi oval shaped silicon parts. Ont the larger part 902 a suture 9021 is integrated with a preformed knot 90212 (modified "bowline" Rettungsknotten", Pasnjak knot) with additional looping 90211 that create a potential fastening for the tension suture length that passes through the central part of the occluder 90. Maneuver of holding the mitral leaflets 1114 and 1115 in semi closed position during puncture with the needle catheter assembly is shown in fig. 10 A . Self opening umbrella (described earlier) 1021 is introduced through a catheter 400 transvenously to the. left atrium 1112 and to left ventricle 1111 over a thin guiding wire 1014 that is exteriorized through the aorta and out of the body through the femoral artery. Pushing the umbrella 1012 out of the covering sheath it opens spontaneously and its retraction over the guiding wire 1014 with a conus on the wire 1013 the mitral leaflets are retracted towards left atrium 1112 . Alternatively the guiding wire can be exteriorized through the left ventricular access introducer 4001. Fig.1OB shows an alternative valve manipulator 1003 with a part 100 that extends spontaneously after exiting the covering catheter and by pushing its end 1002 through the introducer 4001 the manipulator hinder the opening of mitral leaflets 1114 and 1115. The begin of the new procedure using the invention is illustrated in Fig.l l. The kit for direct left ventricular puncture composed of needle 11 covered with dilator 21 is introduced through the intercostals space . through the myocardial wall of left ventricular apex 111 ! , through the posterior mitral leaflet 1115 into the left atrium 1112 under ultrasound and fluoroscopy; a transseptal; sheath 400 is placed into the left atrium. Fig.12 shows introduction of the suture length 30 with wired spiral tip 31 through the dilator 21 to the left atrium through the punctured posterior mitral leaflet 1115. Hereby the suture transporter 40 shown in Fig.3 and 4 can be utilized to push the suture through the dilator 21 (not shown). Through the transseptal sheath 400 a snare catheter 500 with a snare 501 is placed into the left atrium and the wired spiral tip 31 of suture length 30 is snared as shown in Fig.13. The snared end of the suture length 30 is exteriorized through the transseptal sheath 400 out of the body through the femoral vein. Fig.14. illustrates schematic the placement of the silicon implant 82 and 822 over guiding suture length 30 that is placed as a continuous track from the left ventricular apex 1111 through the posterior mitral leaflet 1115 , via the left atrium 1112 through the transseptal sheath 400 to right femoral exit; the implant 82 is connected to the exteriorized end of the suture length 30 and advanced through the femoral vein by retracting the suture length 30 until the implant contacts the left atrial surface of the posterior mitral leaflet 1115. ventricular part of the implant 822 is advanced over the suture 30 through the left ventricular apex and by pushing it with the catheter 21 against the leaflet tissue and connecting it to the left atrial implant part 82; the central part 821 of implant 82 is made serrated to enable safe joining together with the central part of the implant 822. The free wall occluder 90 is introduced through the left ventricular apical sheath over the guiding suture length 30. The suture 30 is placed through the looping of the preformed loop knot on the occluder. Occluder 90 made of sponge part (polyvinilanlcohol or polyurethane) is compressible and thus can be easily introduced through the introducer sheath over the guiding suture 30. By slight pulling the suture length 30 under control of mitral leaflet position by transesophageal echocardiography the systolic amplitude of closing position of the leaflet is adjusted and the wanted length of the intracardiac part of the suture 30 is fixated by the knot 9021x30. Free ends of the knot are cut off by scissors by minimal invasive procedures or by catheter based cutter (as described further in the text) by catheter based procedures. Another variant of implantation of mitral valve tension apparatus is illustrated in Fig.15. Silicon implant (pledget) 83 with integrated suture length 831 is introduced through the transseptal sheath 400. The exteriorized end of the suture 30 is coupled with the suture length 831 by the wired spiral tip 832 (fig.8C), the implant 83 is placed onto the mitral leaflet by retracting the suture length 30 until the joining part of the two suture lengths 30 and 831 is exteriorized and the suture 30 is severed and removed leaving the integrated suture length 831 the only guiding suture intracardially from the implant through the left ventricle 1111 to left ventricular apex and to the occluder 90. Over this suture a thin silicon tube 70 is advanced through the left ventricular apex to contact the ventricular surface of the anterior mitral leaflet 1114 and its prolapsed part 11141. Pulling the suture length 831 the implant 83 pulls with it the leaflet towards the left ventricle and hinders excessive systolic backwards mobility of the prolapsed anterior leaflet part 11141; After the amplitude of excursions was adjusted by pulling the suture lengths 831, the suture is fastened at that point to the oclluder 90 by the knot 9021x831 functioning as the artificial chordae tendineae. An additional variant of the tension apparatus for individual leaflet is shown in Fig.16. Through the left ventricular apical access sheath 4001 the mitral leaflet is punctured consecutively at two sites and two guiding suture tracks 30 and 30' are created from the left ventricular apex through the anterior mitral leaflet 1114 to the left atrium through the transseptal sheath 400 and out of the body through the femoral vein. Implant 84 is apposed onto the exteriorized ends of both guiding suture ends and is advanced to the left atrial surface of the mitral leaflet 11141 by retracting both guiding suture lengths 30 and 30' from the epicardial end until the joining part of the two guiding suture lengths 30 and implant's integrated sutures 841 are exteriorized. The sutures 30 and 30' are severed and removed leaving the integrated suture lengths 841 the only guiding sutures intracardially from the implant through the left ventricle 1111 to left ventricular apex and to the occluder 90. A silicon tube 70 is advanced over both suture lengths 841 from the left ventricular apex towards the ventricular surface of the leaflet; both integrated sutures 841 are traversed through the occluder 90. Pulling both integrated sutures 841 the anterior leaflet 1114 and its prolapsed part 11141 are tightened during the systole at wanted amplitude after which the sutures 841 are fastened to the occluder 90 which is introduced through the sheath 4001 as illustrated in Fig.17 and 17B. Immobilization of the middle of both mitral leaflets is illustrated in Fig 18. Two guiding suture tracks are created from the left ventricular apex through the sheath 4001 via the left ventricle 1111 through the punctured site of the middle of free leaflet margins of the anterior 1114 and posterior 1115 leaflet via the left atrium through the transseptal sheath 400 and out of the body through the femoral vein.; the implant 84 is mounted onto the exteriorized ends of sutures 30 and 30' and is advanced to the left atrial surface of the leaflets by retracting both guiding sutures. Fig 19 shows creation of a knot on the cardiac surface after installation of tension apparatus for the mitral leaflet by catheter based pusher 60 or 601 transportation of the individual knots through the sheath 4001 to the target site: one suture end 841 is held immobilized and individual one step knot is formed with the second suture end 841 around the first suture end 841 and the knot is being pushed with knot pusher to the target site in typical case through the intercostals space to the left ventricular apex. Insertion of the exteriorized suture end into a pusher catheter is accomplished with the instrument 50 as shown in Fig.5A and 5B. Fig 20 shows cutting off of the free ends of the knot by catheter based cutter 102 on cardiac surface (in typical case left ventricular apex) through the sheath 4001 placed through the intercostals space to the left ventricular apex. Detailed description of the catheter based cutter is reported in : "Babic U , Patent No. P-209/94: Serbia &Montenegro Belgrade, Intellectual Property Gazette 2006;2:258-259" the entirety of which is included as a reference herein*. Fig 21 illustrates immobilization of middle of both leaflets 1115 and 1114 with the silicon implant 84 placed onto the atrial surface of the leaflet guided by integrated sutures 841 traced from the implant through both punctured leaflets and through the left ventricular apex covered with the silicon tube 70 and knotted to the occluder 90 with the knot 9021x841._. Approximation of middle of both leaflets with implant 81 placed onto the atrial surface of mitral leaflets and implant 812 placed onto the ventricular surface of the leaflets over two guiding sutures 30 and 30' stabilized with the silicon tube 70 and fastened to the outer element 9021 of the myocardial wall occluder 90 is illustrated in Fig 22.

Claims

1.Methods and means that enable controlling of excursion amplitudes of one or more cardiac valve leaflets or their parts in certain phases of cardiac cycles by implantation of elements that fasten the leaflet tissue to the myocardial wall tissue by catheter based technique on beating heart using interventional/minimal invasive surgical (hybrid) or non- surgical percutaneous access exemplary presented with the catheter based implantation of artificial chordae tendineae.

2. Method and means of claim 1 comprising a pledget implant for apposition onto the left atrial surface of the mitral leaflet whereby the said implant has integrated suture lengths that traverse from the implant through the leaflet and via the left ventricular cavity through the free myocardial wall occluder to witch the said sutures are fastened; comprising further a silicon tube that longitudinally covers the said suture lengths functioning as a system fastener whereby the said tube is interposed between the leaflet and the myocardial wall occluder.

3. Method of claim 2 comprising the utilization of a specially manufactured suture (preferably Nylon or Prolen or so called expanded Polytetrafluoroethylen -PTFE) of various lengths with a wired spiral radiopaque tip for creation of intracardiac guiding suture rails.

4.Method of claim 1 that includes direct puncture of cardiac chamber through the myocardial wall, placement of introducer sheath through this access, puncture of a valve leaflet at one or two sites and creation of one or two guiding suture rails from cardiac entry site through the leaflet to opposite surface of the leaflet, snaring of the wired spiral tip of the guiding suture and its exteriorization through the catheter type sheath; apposition of the implant onto the exteriorized end of the guiding suture and retraction of the tracking suture until the implant contacts the surface of the target leaflet; placement of a stabilization tube between the leaflet's surface opposite to that of implant placement and the free myocardial wall over the tracking suture and fastening of this tension assembly to the myocardial free wall ocluder which is placed across the myocardiac access site.

5. Suture transporter within vasculature comprising an elongated metal cannula through which distal opening the suture is advanced until it exits through the proximal opening where it can be fixated or released; in fixated position pushing the metal cannula the suture within its lumen is being pushed too, releasing the suture on proximal part and retracting the cannula leaves the distal suture end in place; repeating this maneuver a suture can be transported to distant location through the cardiovascular catheters.

6 Implant- pledget made of biocompatible polymers preferably of silicon that can be compressed to be situated within a cardiovascular sheath and has a sufficient "expanded" surface to amortize the tension forces by dispersing them onto larger area and thus avoiding leaflet damage during fixation to the myocardial free wall and during incessant activity of cardiac structures during lifespan whereby the said implant is made ready to be coupled onto the end of an exteriorized guiding suture for advancement through a catheter type access by retracting the guiding suture track until the implant contacts the one surface of the target leaflet through which the guiding suture traverses.

7. The implant of claim 6 made preferable of silicon comprising two parts atrial and ventricular one and both placed individually onto the atrial and ventricular leaflet's surfaces respectively over the same suture track.

8. Implant of claim 6 with integrated suture length prepared for coupling with exteriorized guiding suture end whereby the said integrated suture comprises a wired spiral tip through which a guiding suture end can be advanced and fixated by crimping the wired spiral tip.

9. Implant of claim 6 with two suture lengths integrated with wired spiral connectors for coupling to 2 guiding suture tracks.

10. Myocardial free wall occluder comprising a central part made of resilient sponge biocompatible polymer such as polyvinilalcohol or polyurethane reinforced with a suture mash and 2 elements on both ends: smaller within the heart of semi oval shape made of silicon and outer larger of same form and material but of larger diameter with integrated suture whereby the said integrated suture has preformed loop knot which can secure the end of the tension suture after its passage from the implant through the leaflet across the left ventricle covered with a silicon tube through the occluder. With this integrated suture the artificial tension apparatus is fastened to the occluder at wanted level.

11. Methods and means of claim 1 modified for approximation of middle parts of both mitral leaflets by implantation of tension system whereby two suture tracks traverse individually through middle segments of the free leaflet margins of both leaflets and are stabilized by convergent passage through a silicon tube interposed between the leaflets and the left ventricular free myocardial wall occluder.