WO2012040865A1

WO2012040865A1 - Medical apparatus and method for heart valve repair

Info

Publication number: WO2012040865A1
Application number: PCT/CH2011/000231
Authority: WO
Inventors: Alberto Weber; Rolf Vogel; Stijn Vandenberghe; Thierry Carrel
Original assignee: Alberto Weber; Rolf Vogel; Stijn Vandenberghe; Thierry Carrel
Priority date: 2010-10-01
Filing date: 2011-10-03
Publication date: 2012-04-05
Also published as: WO2012040865A9

Abstract

In accordance with an aspect of the invention, a surgical apparatus for treating atrioventricular valve prolapse of the human heart is provided. The apparatus is capable of minimally invasive surgical treatment of the beating heart and comprises a catheter (1). It is firstly equipped for temporarily stabilizing a heart valve leaflet during heart beating. It is secondly equipped for implanting a heart valve stabilizer that permanently treats the prolapse. The heart valve stabilizer that can be moved forward in the catheter and comprises an artificial chord (32) for connecting the leaflet to the papillary muscle or other site in the myocardium, an anchor (33) to be anchored in the papillary muscle or other site in the myocardium and equipped for being connected to the artificial chord, and a fixation tool equipped for being connected to the leaflet and to the artificial chord.

Description

MEDICAL APPARATUS AND METHOD FOR HEART VALVE

REPAIR

FIELD OF THE INVENTION

The invention is in the field of surgical, for example interventional, devices for heart valve repair. It more particularly relates to an apparatus for repairing an atrioventricular, in particular the mitral heart valve in a minimally invasive manner.

BACKGROUND OF THE INVENTION

Prolapses of a leaflet of the mitral valve into the left atrium and resulting valve insufficiency can cause serious dysfunctions of the heart. One reason for such prolapse is a damaging of the tendons (chordae tendinae) that connect the leaflets of the mitral valve to the papillary muscle through the left ventricle. Such a damage may for example be a result of a myocardial infarction.

A repair of such a prolapse demands the leaflet or leaflets to be re-connected to the papillary muscle, for example by synthetic fibres, such as Gore-tex® fibres. A disadvantage of such a repair process is that it is only possible while the heart is inactive, thus the surgical repair demands that the heart is stopped and drained of blood, while a cardiopulmonary bypass is used. However, it would be desirable to have a, possibly even minimally invasive, surgical method that is suitable of being performed while the heart is beating.

There have been proposals to use minimally invasive techniques for the treatment of atrioventricular valve prolapses. US 2004/0003819 teaches to treat the prolapse by grasping two leaflets by a catheter and to suture them together. Also US 201070042147 teaches techniques of introducing a surgical suture by means of a catheter to treat this kind of prolapse. US 2008/195126 teaches methods for repairing the heart that are based on an anchor to be attached to the papillary muscle and a suture that is attached to the anchor and for example the leaflet or other place in the heart.

These prior art methods that are based on sutures feature the disadvantage that suturing in minimally invasive setups is difficult, and therefore sufficiently reliable stability is often difficult to achieve.

SUMMARY OF THE INVENTION

The present invention is designed to treat cardiac valve regurgitation or insufficiency, particularly mitral valve regurgitation with leaflet prolapse, in a beating heart but can also be applied during open heart surgery.

In accordance with an aspect of the invention, a surgical apparatus for treating atrioventricular valve prolapse of the human heart is provided. The apparatus is capable of minimally invasive surgical treatment of the beating heart and comprises a catheter. It is firstly equipped for temporarily stabilizing a heart valve leaflet during heart beating. It is secondly equipped for implanting a heart valve stabilizer that permanently treats the prolapse. The heart valve stabilizer that can be moved forward in the catheter and comprises an artificial chord for connecting the leaflet to the papillary muscle or other site in the myocardium, an anchor to be anchored in the papillary muscle or other site in the myocardium and equipped for being connected to the artificial chord, and a fixation tool equipped for being connected to the leaflet and to the artificial chord.

In this, the connection between the fixation tool and the artificial chord on the one hand and/or the connection between the artificial chord and the anchor on the other hand can be pre-made, by the manufacturer of the apparatus or by the surgeon immediately prior to the surgical operation, or can be made in situ.

The fixation tool is an implantable device designed and equipped for being permanently attached to the leaflet. It has a pre-defined shape and is thus a 3D body different from a mere suture.

The catheter is preferably steerable and has a dimension making it suitable for minimally invasive surgery. It may be inserted via a blood vessel. More specifically, it may for example be designed for percutaneous, endovascular, and intra-cardiac trans-septal application. Its distal end may approach the mitral valve via the right atrium through the interatrial septum and via the left atrium. The catheter may reach the mitral valve also retrograde via the aorta, aortic valve and left ventricle. Other approaches, including transapical, are possible.

In many embodiments, the fixation tool is equipped for being fastened to the leaflet through a perforation thereof. More in particular, it may comprise two flange portions designed to lie against the (superior and inferior) surfaces of the leaflet (the leaflet then is held between the flange portions) and a waist portion that reaches through the perforation and connects the flange portions. The flange portions may be capable of abutting against the respective surface of the leaflet and may be disc- shaped and thus be disc portions or have the shape of (for example radial) fingers or of wires or plates or other element of any other shape.

To this end, the fixation tool may be designed in accordance with one of two possibilities:

According to a first possibility, the fixation tool is made of a shape memory metal, is capable of being held in a preliminary shape with a first maximum outer transversal diameter (perpendicular to the proximodistal axis) that fits into the catheter, and upon being released expands into a final shape that comprises the first and second flange portions and the waist portion - similar to an Amplatzer device known in heart surgery for other purposes. In the final shape, the fixation tool has a second maximum transversal outer diameter, the second maximum transversal outer diameter being defined by the diameter of the greater one of the flange portions and being greater than the first maximum transversal outer diameter.

According to a second possibility, the fixation tool comprises two fixation tool parts. A fist fixation tool part has a shaft and possibly the first flange portion pre-mounted to the shaft. The first and second fixation tool parts are then equipped for being mounted to each other in situ, one fixation tool part being brought in place with respect to the preliminarily stabilized leaflet from a proximal side and the other one from a distal side. After being assembled, the shaft constitutes the waist portion. In order to be capable of being assembled in situ, a suitable mechanism may be provided. For example, one of the parts may comprise a resilient portion capable of forming a clamping mechanism. As an other example a bayonet-closure-like mechanism may be chosen. Other mechanisms of in-situ assembling two parts may be know in the art.

The apparatus in addition to the catheter and the heart valve stabilizer comprises equipment for implanting the fixation tool. This equipment may for example include a proximal jaw and a distal jaw, at least the distal jaw being deployable from the catheter, one of the jaws being equipped to hold the first device part and the other one of the jaws being equipped to hold the second tool part. It may optionally further comprise a needle that pre-pierces the leaflet prior to introduction of the first tool part. The needle then is deployable from one jaw and may optionally be guided by the other one of the jaws.

The leaflet tissue may be rather elastic, and the leaflet thus difficult to penetrate. Using a tool (such as the needle) that is deployed from a first jaw while the second jaw serves as an abutment may be advantageous. If the first penetration is done by a needle, the fixation tool may optionally comprise an axial cannulation, the needle being in the cannulation during the step (subsequent to the piercing) of the fixation tool penetrating the leaflet.

Guidance of such needle and/or of the shaft of the first tool part by the respective other jaw has a also the advantage of absorbing angular momenta that may arise on the entire set-up due to forces acting during penetration of the leaflet and/or assembly of the first and second tool parts. Optionally, the respective other jaw may comprise a mechanism to temporarily fix also the axial position of the needle (if any) and/or the first tool part. Such mechanism may for example be a releasable latch mechanism. The invention also concerns a fixation tool of the hereinbefore described kind, and an apparatus comprising such fixation tool and further comprising equipment for implanting such fixation tool in a minimally invasive manner. Especially, in accordance with an aspect, the invention concerns such a fixation tool and such an apparatus having any combination features of fixation tools and equipment for its implantation described in the present application.

The heart valve stabilizer further comprises a distal anchor, especially to be anchored in the papillary muscle. The present invention also, in accordance with an aspect, concerns an anchor for being anchored in the papillary muscle to provide an anchor for an artificial chord in a treatment of atrioventricular (especially mitral) valve prolapse, which anchor can be used in an apparatus of the hereinbefore or hereinafter described kind or in any other set-up for treating a heart valve prolapse. The following discussion of possible features of the anchor refer to both, an anchor optionally being part of an apparatus according to different aspects o the invention, and an anchor for any set-up of treating heart valve prolapse.

The distal anchor comprises barbs. The anchor comprises anchor body that for example forms a distal anchor tip. In some embodiments, the barbs are formed integrally with the anchor, i.e. the anchor body and the barbs are of one piece. In other embodiments, the barbs are separate elements.

The distal anchor in accordance with this aspect further comprises a guiding element that is movable with respect to the anchor body between a first and a second position. For example, the guiding element may be slidable along a proximodistal axis between the first position and the second position. The barbs in these embodiments are pre-shaped and are for example of a shape memory material, such as Nitinol. In the first position of the guiding element, the barbs are held in a retreated position in which an outer diameter (perpendicular to the proximodistal axis) of the entire anchor (including the barbs) is small. By moving the guiding element to a second position, the barbs may be released to project outwardly.

In examples, distal ends of the barbs may be held in openings of the distal part of the anchor body, whereas proximal ends of the barbs are held by the guiding element. When the guiding element then is moved into the distal direction to the second position, the barbs are released. To this end, for example two possibilities exist:

- According to a first possibility, the axial position of the barbs (or of at least some of the barbs) with respect to the guiding element is fixed, whereas the barbs are slidable with respect to the anchor body. By movement of the guiding element towards the distal direction, the barbs can be distally pushed out of the anchor body, and the distal ends of the barbs then may be bent away from the proximodistal axis. In this, it is also possible to have a segmented or otherwise divided guiding element, so that only selected ones of the barbs can be pushed out to function as barbs.

- According to a second possibility, the axial position of the barbs with respect to the anchor body is fixed. The movement of the guiding element then releases the proximal ends of the barbs, so that the proximal ends of the barbs are bent away from the proximodistal axis.

The first possibility has the advantage that the anchor works also with a minimal penetration depth because the barbs can be arranged rather distally and it is not necessary for the effect to work that the anchor is introduced into the tissue to an extent that the proximal ends of the barbs are fully within the tissue, as is the case for prior art barbs. Thus, the first possibility may help to reduce the possibility of undesirably perforating the heart.

The invention also concerns a surgical method of treating a heart valve. The method comprises the steps of:

• providing a catheter;

• moving a distal end of the catheter to approach a leaflet of the heart valve;

• when the distal end of the catheter has approached the leaflet, temporarily stabilizing the leaflet;

• fastening an anchor of a heart valve stabilizer to the papillary muscle of the heart's ventricle;

• perforating the temporarily stabilized leaflet to yield a perforation;

• fastening a fixation tool to the temporarily stabilized leaflet so that the fixation tool reaches through the perforation;

• wherein the fixation tool and the anchor are connected to an artificial chord; and

• de-activating the stabilizing mechanism and removing the catheter;

• wherein the steps of fastening the anchor to the papillary muscle and of fastening the fixation tool to the leaflet are carried out in arbitrary sequence. The temporary stabilization may be done by a grasping mechanism and/or by any other suitable means, such as suction etc.

The step of perforating may be done by a device (needle) prior to the fastening of the fixation too. Alternatively, it may be done simultaneously with the step of fastening the fixation tool, for example by providing a part of the fixation tool with a piercing edge.

The connection between the fixation tool and the artificial chord can be pre-made. Alternatively, it can be done at any stage during the process, for example by in-situ crimping or laser welding. Similarly, also the connection between the artificial chord and the distal anchor can be pre-made or done in situ, again by any suitable method, for example crimping or laser welding.

The temporary heart valve leaflet stabilization can be active during the fastening of the anchor or not. In other words, if the fixation tool is fastened prior to the anchoring of the distal anchor, then the stabilization can be done already prior to and during anchoring or can be done only after the anchoring. Similarly, if the anchoring is done after the fastening of the fixation tool, then the stabilization may be maintained during the implantation of the anchor or can be released before.

The steps of fastening the anchor and of fastening the fixation tool (while the leaflet is temporarily stabilized) can be carried out by the same one catheter, the respective tools being deployed from its distal end, the catheter then having one lumen or more than one lumina. Alternatively a primary catheter with more than one lumina can be used, so that for example an inner catheter for the distal anchor can be deployed from the primary catheter to fasten the anchor. As yet another alternative, the anchor could be shot across the ventricle from the place where the leaflet is stabilized.

In the step of anchoring the distal anchor, often the papillary muscle may move fast and strongly. To this end, a guide may be used for a safe and exact placement. According to a first option, an artificial guide may be introduced that, for example aided by navigation, may help to direct the catheter (or other means) by which the distal anchor is moved into place prior to being anchored. A timer that is synchronized with the periodic muscle movement may aid in the anchoring process. In addition or as an alternative, a natural guide may be used. Such a natural guide is constituted for example by the existing natural chord, even if it is damaged somehow. To this end, according to an option, the distal anchor and/or the catheter by which the distal anchor is placed may comprise a guidance portion engaging with the natural chord. Such a guidance portion may be constituted by a hook or a guiding slot or similar. Now, the temporary heart valve leaflet stabilization is discussed. The temporary heart valve leaflet stabilization may for example be triggered by the surgeon himself who operates the apparatus having the navigation information available as known from minimally invasive heart (and other) surgery, including ultrasonic image, etc. In addition or as an alternative, (in any embodiment of the invention), an automatic mechanism activated by a light and/or electromagnetic and/or impedance sensor or a manually activatable mechanism aided by such sensor may be provided.

The temporary heart valve leaflet stabilization may according to one possibility be achieved by a clamping mechanism: two parts, the deployment of one of which can be controlled independently of a position of the other, may each form a jaw, between which the leaflet can be clamped. The jaws may at the same time constitute the jaws of the hereinbefore described kind equipped for holding and/or guiding the first and second fixation tool parts, respectively, so that the temporary leaflet stabilization may be provided by the equipment required to implant the fixation tool. In addition or as an alternative, a separate temporary stabilization mechanism may be provided, the separate temporary stabilization mechanism being provided by means of a lumen of the catheter separate from the lumen from which the fixation tool and other elements of the heart valve stabilizer are deployed.

In accordance with a further aspect of the present invention, therefore, for example combined with any other aspect of the invention described herein, a surgical apparatus for treating a heart valve is provided, the surgical apparatus comprising a catheter, the catheter comprising a first lumen and a second lumen, the first lumen comprising a leaflet stabilizer capable of stabilizing a leaflet of the mitral valve during heart beating, the apparatus further comprising a heart valve stabilizer that can be moved forward in the second lumen, moved out of the second lumen and attached to tissue of the leaflet and/or to tissue of the papillary muscle.

In addition to the first and second lumen, the catheter may have one or more further lumina.

An (alternative to the above-described clamping) example of a leaflet stabilizer of the first lumen is a vacuum system. The first lumen may proximally be connected to a suction system so that a vacuum causes the leaflet to rest against a distal port of the first lumen. In addition or as an alternative, also mechanical stabilizers are possible, for example a temporary fixation tool as described hereinafter in more detail.

The suction device of embodiments of the invention does not permanently generate a vacuum but can be activated when the catheter's distal end approaches the leaflet. To this end, for example an optional light or electromagnetic or impedance sensor installed on the tip of the catheter can detect an approaching moving leaflet and activate the vacuum, and as a consequence fixate the prolapsing leaflet portion during heart beating. This is achieved with insignificant blood loss. The device, in accordance with an other option, works also without a light sensor, just by approaching the catheter to the leaflet and activating the suction device manually, for example while it is traced, for example by echocardiography and x-ray. The suction system, comprising the suction device and the first lumen, allows temporary fixation of valve leaflets during treatments, without causing injuries by clamping and other mechanisms.

The second lumen may serve as a working port to deploy one or more repair tools while the valve is stabilized by the suction system. This port is stabilized within the catheter and separated from the suction system so that the suction force does not act via the second lumen. The second lumen together with the heart valve stabilizer provides an effector system for deployment and or application of valve repair treatments.

The heart valve stabilizer may comprise different working tools. Especially, it may comprise one or more anchors that can be connected to tissue.

The approach that stipulates a first lumen for suction and a second lumen for deploying one or more working tools, has the significant advantage that the working tool can access the operation site through a perforation in the temporarily stabilized leaflet or alongside the leaflet without causing a permanent blood loss through suctioning blood through the catheter. A possible perforation of the leaflet or an other exit (like a clipping device) for the working tool from the catheter is not subject to the vacuum caused by the suction. The form of the catheter can be variable. The suction and working ports can be open at the distal end of the catheter, in a fashion that the tip of the catheter is approaching to the leaflet to treat. However, the suction and working port openings can also be designed at one or both sides of the catheter in order stabilize in the leaflet by pulling the catheter transvalvular into the next cavity (the ventricle in case of mitral valve if the device advances towards the valve from the atrium) and sliding the side of the catheter close to the leaflet edge and, by doing this, fixate one leaflet or more than one leaflets at a time.

In order to support the suction system or as alternative thereto, the leaflet stabilizer may comprise an additional mechanical temporary fixation tool that is brought into place through second lumen and for example through the valve leaflet. Such a temporary fixation tool may for instance be a tool with retractable tips or a mini- Amplatzer® or a clip or a staple.

The apparatus according to this further aspect is suitable for any kind of working tool that is suitable for an operation step in heart valve repair and that fits in a volume within a catheter of the described kind. This includes, but is not limited to:

A needle, for example with a harpoon-like tip to be anchored in tissue;

A suture for suturing tissue parts together;

A fibre (such as a suture fibre) for serving as artificial chord; - A temporal leaflet stabilizer for temporarily mechanically affixing a leaflet to the distal end of the catheter;

- A permanent leaflet stabilizer for permanently being connected to the leaflet and to an artificial or possibly natural chord; such a permanent stabilizer may also serve to occlude a possible perforation of the leaflet generated during surgery;

- A permanent perforation occluder;

A light source, such as a light conductor (optical fibre or fibre bundle etc.) connected to a laser light source for providing energy, for example for a punctuation and/or for an in-situ welding or cutting process;

- A mechanical perforation tool, such as a punch or a cutter, that serves for perforating the leaflet at the spot where the catheter is attached, through which perforation further tools may be introduced to treat the heart;

A gluing set that includes a glue portion and a glue dispenser to stabilize the heart valve by gluing tissue parts together.

Arbitrary combinations of the above are possible. For such combinations, the working tools may be combined (such as an artificial chord that is already connected to a needle anchor) or may be applied one after an other, for example by subsequently introducing the tools one after the other in the catheter. In embodiments, the tools or some of the tools may be inserted in an additional, inner steerable catheter that is slided through the second lumen and steered through the portions of the heart across which the leaflet has to be fixed, such as through the left ventricle if an artificial chord has to connect the leaflet to the papillary muscle or other site in the ventricle. Such a steerable catheter may comprise a sharp distal edge so that it serves at the same time as a mechanical punch.

A surgical method of treating a heart valve according to this further aspect may comprise the steps of

- providing a catheter with a first lumen and a second lumen (and possibly one or more further lumina), moving a distal end of the catheter to approach a leaflet of the heart valve,

- when the distal end of the catheter has approached the leaflet, stabilizing the leaflet with a grasping mechanism applied via the first lumen to temporarily stabilize the leaflet, - deploying a working tool from the second lumen and using the working tool to treat the heart valve, and de-activating the stabilizing mechanism and removing the catheter.

The step of stabilizing the leaflet with a grasping mechanism may be a step of turning on a suction force through the first lumen to grasp the leaflet by a suction force. Then, the step of de-activating the stabilizing mechanism may be a step of turning off the suction force. In this, the suction force may be applied to grasp the leaflet during the treatment by the working tool. In addition or as an alternative, a temporary fixation tool may be used to affix the leaflet to the distal end of the catheter while the working tool is in operation. The working tool may be any working tool suitable for an operation step in heart valve treatment and fitting in a lumen of a catheter for minimally invasive surgery. Especially, it may be one of the above-specified working tools. Of course, several working tools may be used sequentially and or simultaneously for the surgical treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

Hereinafter, principles and embodiments of the invention are described referring to drawings. In the drawings, same reference numbers refer to same or analogous elements. The drawings show:

- Fig. lb and lb a distal end of a catheter of an exemplary embodiment of an apparatus according to the invention, in a view from the distal end, and in longitudinal section, respectively;

- Fig. 2a and 2b schematically the principle of grasping a leaflet of a mitral valve by an apparatus according to embodiments of the invention;

Figs. 3a-3c steps of a surgical operation;

Figs 4a-4c, schematically, the maneuverability of a catheter; . 5a-5c the working principle of a tool with a barb-like tip;

Figs. 6a-6c the principle of a mini-Amplatzer;

Figs. 7a and 7b the use of a mini-Amplatzer for fixing a leaflet to an artificial chord;

- Figs. 8a-8d a temporary leaflet stabilization;

Figs 9a, 9b, 10 and 1 1 alternative designs of distal ends of a catheter;

Fig. 12 the principle of an to an other side of a left ventricle;

Fig. 13a and 13b a distal anchor in two different configurations;

Figs. 14a- 14c an other distal anchor in different configurations;

- Figs. 15a and 15b yet another distal anchor in two different configurations;

Figs. 16a and 16b a principle of implanting a fixation tool (proximal anchor):

Figs. 17a- 17d a fixation tool and parts thereof; Figs. 18a-18d a equipment for temporarily stabilizing the heart valve leaflet and for implanting a fixation tool in different configurations;

Fig. 19 a detail of a jaw of the equipment of Figs 18a-18d;

Figs 20a-20h steps of a process of implanting a fixation tool, wherein the process steps at the same time illustrate different optional features of the equipment; and

Figs. 21a-23 principles of guiding the catheter by natural chords during implantation of the distal anchor.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The steerable two-lumen catheter 1 shown in Fig. la and Fig. lb has an outer catheter tube 2 and an inner catheter tube 3 to together define a first lumen A and a second lumen B. In the shown embodiment, the catheter tubes 2, 3 are approximately circular in cross section. In the depicted configuration, the first lumen A is defined by the space between the outer and inner catheter tubes 2, 3, whereas the second lumen B is the interior of the inner catheter tube 3. Between the catheter tubes 2, 3 a plurality of connectors 4 secures an approximate relative position of the first and second catheter tubes.

At least the outer catheter tube 2 is of a material or material combination that causes the catheter to sustain the pressure that is encountered in the human heart while a vacuum (underpressure) is applied in the interior. The catheter may further comprise a distal tissue sensor 5 that detects proximity of human tissue and can be used for triggering the suction process once the catheter is close to the leaflet. In following figures, the tissue sensor 5 is sometimes denoted by the reference letter "C".

In variants of the depicted configuration, one or more of the following may hold:

instead of the depicted four connectors 4 or four groups of axially spaced connectors 4, any other number of connectors may be present, for example one connector (that may optionally be axially extended along a substantial portion of the catheter length), or two, three, five etc. connectors/groups of connectors may be present, at equal or non-equal circumferential spacings. In other configurations (see also below) no specific connectors are necessary. For example, the inner tube may be placed off-center in the outer tube and for example affixed to the interior wall of the latter along an axial line.

the shape of the catheter and/or the shape of the inner catheter tube may be of a non-circular cross section. For example, the inner catheter tube by have an elliptical cross section while the outer catheter is circular in cross section. Optionally, then the major extension of the ellipse may approximately correspond to the inner diameter of the outer catheter tube, so that the inner tube touches the interior wall of the outer tube along two axial lines and is attached thereto, and the first lumen A has the cross section of two separate moon-shaped elements. Alternatively, other cross sections such as approximately rectangular or irregular shapes are possible for the catheter as a whole (the outer catheter tube if applicable) and/or of the inner catheter tube (the second lumen if applicable). Instead of comprising an outer and an inner tube, the catheter may comprise a single tube with an axially extended wall that separates the first lumen from the second lumen; such a wall may be straight or have any other shape.

The device can comprise more than two tubes or lumina instead of only two depending on how many working ports or stabilizing systems are needed.

An apparatus for treating a heart valve, especially the mitral valve, in addition to the catheter comprises a suction device for generating a vacuum in the first lumen and at least one tool for treating the heart valve. Examples of such tools are described in somewhat more detail further below.

A possible way to use the apparatus for heart valve treatment is described referring to Figures 2a and 2b illustrating the principle of grasping the heart valve leaflet and subsequent figures illustrating possible treatment steps.

Figure 2a shows, in part, a section through the left ventricle of the human heart with the mitral valve being on the left. A first leaflet 21 of the mitral valve prolapses into the left atrium (not shown) because a chord 14 for connecting the leaflet 21 to the papillary muscle 11 is loose. Further chords 13 are shown to be intact. Also the second leaflet 22 is depicted to be intact.

In Fig. 2a, the catheter 1 approaches the leaflet 21. The catheter end may advance towards the mitral valve via the right atrium, through the interartial septum, and then via the left atrium, thus from the left atrium side. As soon as a tissue detector C detects proximity to the leaflet, the vacuum sets in, and the suction force temporarily secures the leaflet to the proximal end of the catheter 1 (Fig. 2b). Thereafter, a tool may be moved forward through the second lumen B to treat the valve leaflet 21.

In Figures 3a-3c, again the left ventricle with the papillary muscle 1 1 and the mitral valve 21, 22 is depicted. One chord 14 of the chordae tendinae 13, 14 is again shown to be defective. Fig. 3a depicts the situation with the suction system grasping the leaflet 21 and with a tool 30 advancing towards the leaflet in the second lumen. The tool is slided from the exterior into the heart through the catheter working port and through the grasped leaflet. The tool 30 comprises a needle 33 with a barbed hook (a harpoon-like needle) to be anchored in the papillary muscle. The needle 33 is attached - for example welded - to an artificial chord 32. The artificial chord may be a gore-tex suture or an other filament. The needle 33, the artificial chord 32 and a possible fixation tool for fixing a proximal portion of the chord 32 to the leaflet together form a heart valve stabilizer that is to remain in the patient's body after the surgical operation.

Once the leaflet is stabilized by the suction system (either mechanically supported or not, as explained hereinafter), the leaflet may according to an option be perforated in order to deploy the needle with the suture. This can be done by sliding a laser catheter through the working port and using the laser to perforate the leaflet. As an alternative, the leaflet may be mechanically perforated, for example by a punch. In the example depicted in Fig. 3b, the tool 30 comprises an inner steerable catheter 31 with a sharp end that serves as the punch and then advances through the ventricle to the papillary muscle. During advancement through the leaflet and further, the heart valve stabilizer is covered by the inner steerable catheter 31 with the harpoon-like needle retracted; especially, the barb structures may be held back by the catheter against a spring force. The steerable construct is guided (for example echocardiographic or monitored by x-ray) towards a papillary muscle group, which is then punctured. By retrieving the hollow catheter 31 (Fig. 3c), the barb structure of the needle 33 opens and gets fixated into the muscle. The attached gore-tex suture is then fixated at the leaflet level in a for example echocardiographic adjusted length.

In a variant of the method illustrated referring to Figures 3a-3c, the distal anchor of the artificial chord may be shot into the papillary muscle through the ventricle, and for example also through the leaflet. To this end, the energy conserved in a pre- tensioned spring or other conserved energy may be instantaneously released. An other way to conserve mechanical energy is to provide an inflatable balloon within the catheter. The inflatable balloon may for example be provided with a bolus of saline under pressure proximally adjacent the anchor. When the balloon is inflated, the catheter may deform. When the balloon is punctured, the stored energy is instantaneously released, the catheter re-attains its original form and the anchor is expelled towards the distal direction.

An alternative energy source for the shooting step can be electromagnetic forces.

To guide the shooting of the device it is possible to add a targeted system that can be for instance comprise a magnetic ring held at the papillary muscle to 'attract' the shot anchoring system. Between the magnetic ring and the catheter it is possible to provide a guiding catheter.

Figures 4a-4c yet illustrates the principle of a steerable catheter as is used as catheter 1 that contains the two lumina and, as single lumen catheter for embodiments described hereinafter, and/or if present, as steerable inner catheter. The catheter's distal end may be steered to assume a particular orientation and advanced in the according direction, as illustrated in Figures 4a-4c. The principle of steerable catheters is known in minimally invasive surgery and not explained any further here. Figures 5a-5c show in somewhat more detail elements of the tool, including the artificial chord 32 with the harpoon-like needle 33, and the steerable inner catheter 31.

One example of a tool for fixing the proximal end of the artificial chord to the leaflet 21 is illustrated in Figures 6a-6c and Figures 7a-7b. Figures 6a-6c show a fixation tool 41 the working principle of which resembles the principle of an Amplatzer occluder. The fixation tool 41 is of a resilient material (for example nitinol). If held in a catheter (Fig. 6c), it has an approximately tubular or cylindrical shape (Fig. 6b), but if it is released, it expands to the shape depicted in Fig. 6a with two disc portions 41.1 , 41.2 and a waist portion 41.3 between the disc portions. The disc portions may have, as known from Amplatzer tools, a meshed structure. As illustrated in Figs 7a and 7b, after the approaching step and after the step of fixing the distal end of the stabilizer to the papillary muscle, the catheter 1 is retracted while the artificial chord 32 is tensioned and while the fixation tool 41 is kept in place at the site of perforation of the leaflet. Retraction of the catheter causes the fixation tool to expand into the configuration of Fig. 6a and to therefore occlude the perforation and fix the leaflet. The artificial chord may thereby also be clamped in an interior of the fixation tool (Fig. 7b, right panel), and/or an in-situ attached or produced retaining portion 42 (that may be a suture retainer or a knot etc.) on the artificial chord may keep the chord from being pulled out towards the distal direction.

Figures 8a and 8b yet depict an optional mechanical auxiliary temporary fixation tool. Such a temporary fixation tool 51 may be put in place prior to the steps of bringing the heart valve stabilizer into position and of permanently fixing the heart valve stabilizer to the leaflet. It may be based on a similar principle as the (permanent) fixation tool 41 that fixes the stabilizer to the leaflet, but it has the purpose of assisting the connection between the distal end of the catheter and the leaflet. Alternatively, the suction force may be turned off after placement of such a temporary fixation tool, so that after an initial grasping of the leaflet by suction through the first lumen the temporary fixation tool stabilizes the leaflet during surgical operation instead of the suction system.

In the embodiment shown in Figures 8a and 8b, the temporary fixation tool 51 in contrast to the permanent fixation tool is configured as a double star device with two groups of retractable tips 51.1, 51.2. As shown in Figures 8c and 8d, a first group of retractable tips 51.1 is used for holding the leaflet relative to the catheter, while the second group 51.2 may stabilize the temporary fixation tool 51 against the catheter. The waist portion 51.3 between the two groups of retractable tips penetrates the leaflet.

Figures 9a and 9b show a first variant of a distal end of the catheter. The first lumen A as well as the second lumen B are accessible from a lateral side. By this construction, it becomes possible to move the catheter slightly into the ventricle and to grasp an edge of the damaged leaflet 21, and it may be unnecessary to pierce the leaflet by a tool during the operation.

The embodiment of Figure 10 comprises two lateral openings of the catheter 1 , for example to grasp both of the leaflets of the mitral valve. In the embodiment of Figure 11, the first lumen A is located centrally and is surrounded by the second lumen B. Also such a configuration can be used to grasp an edge of the leaflet so that it may be unnecessary to pierce the leaflet.

At the end of the procedures, the suction is turned off, the leaflet released and the catheter retrieved. Figure 12 yet shows the principle of shooting a working tool (an anchor for an artificial chord) to an other side of a chamber of a heart, such as a left ventricle. The anchor - which may be a tip with a barb feature, as illustrated in previous figures - is shot from a catheter 1 across the blood filled chamber. In the depicted embodiment, this is done from the catheter of the apparatus according to the invention, which catheter temporarily stabilizes the leaflet 21, into the papillary muscle 15 (the principle of shooting an anchor with an artificial chord/suture attached to it from a catheter into tissue across a blood filled space could also apply in other interventional cardiology treatments). A magnetic ring target 61 is used to direct the shot anchoring system. Such a ring target 61 may have been introduced by an other catheter, or via a lumen of the catheter 1. Alternatively, it may be placed externally of the heart or even externally of the patient's body. Especially in the latter case, the target does not need to be a ring magnet but may for example be of an electromagnetic type or be based on any other kind of interaction acting through human tissue. In addition or as an alternative to the target 61, a guiding tube 63 may be present, the guiding tube being catheter like. Holding and directing means 62, 64 for the target and the catheter, respectively, are also illustrated in the figure.

The distal anchor 33 shown in Figures 13a and 13b is configured to be introduced into the papillary muscle. Like in the subsequently described embodiments or in any embodiment of a distal anchor, this is for example done using a steerable catheter; either an inner steerable catheter of the above-described kind that can be deployed from the main catheter or by the main catheter itself.

The distal anchor comprises a tip portion 71 and proximally thereof a shaft portion 72. The tip portion and the shaft portion are formed integrally and constitute together an anchor body. The distal anchor 33 further comprises a plurality of pre-formed barbs 74 that are held proximally by a guiding element 75 and distally by guiding holes 71.2 of the tip portion. The guiding element 75 is torus-shaped encompassing the shaft portion and being slidable on it along the longitudinal (proximodistal) axis. In the depicted configuration, the shaft portion is not circularly symmetric but has a plurality of grooves into which the pre-formed barbs 74 (or, alternatively, corresponding protrusions of the guiding element 75) engage to fix the angular position. The outer contour of the guiding element in the depicted embodiment and other embodiments is such that its radial extension corresponds to the radial extension of the tip portion 71.

The proximal ends of the pre-shaped barbs 74 or of at least some of the pre-shaped barbs may fixedly connected to the guiding element 75. The distal ends of at least these pre-shaped barbs are slidable in the guiding holes 71.2, which guiding holes 71.2 are open to the distal side. By sliding the guiding element towards the distal direction, the pre-shaped barbs fixedly connected to it are forced out of the guiding holes. The pre-shaped barbs 74 may be pre-shaped to fold outward in a manner as shown in Fig. 13b. may for example by made of a shape memory material, such as Nitinol. Other materials, including ordinary (not shape memory) metals of medical quality that can be pre-tensioned to assume a particular shape after being released are possible.

As an alternative to fixing the proximal ends of at least some of the pre-shaped barbs 74 to the guiding element 75, it is also possible to provide a configuration in which such fixation is done in situ, for example by laser welding. Similarly, the respective other barbs may be fixed to the tip portion. In addition or as an alternative, some of the barbs can be left away (i.e. in only some of the guiding indentations of the guiding element and guiding holes 71.2 of the tip portion are there barbs. As yet another alternative, the guiding element may be segmented or otherwise divided so that a plurality of guiding elements results, each one of the plurality of guiding elements connected to one or more of the barbs. By any one of these means, the barbs become individually controllable: if necessary, only one or two or more barbs can be moved forward depending on in which muscle portions the anchor is to be anchored. Embodiments based on this principle feature the advantage that the tip portion has to penetrate only little into the papillary muscle tissue for the barbs to be able to become effective. This principle thus permits less tissue penetration and therefore minimizes the risk of hear wall perforation.

In all embodiments, the barbs' tips and/or (if present) edges may be polished and sharpened so that they penetrate the tissue smoothly when the anchor is pulled back.

The embodiment of Figures 14a-14c comprises a distal anchor that is formed by a barbed hook. The barbs 82 are one-piece/formed integrally with the tip portion 71 and project outwardly when released (Fig. 14b, Fig. 14c), especially from its proximal end. During approximation, the barbs 82 are held in an interior position by the catheter 1, 31 or a guiding rod deployed with the anchor. After the anchor is pushed out of the catheter 1, 31 (or the guiding rod, respectively), the barbs shoot outwardly due to the material's pre-shaping. Figs 14a and 14b yet depict a pusher portion 81 by which the pushing out is achieved.

The distal ends of the barbs 91 in the embodiment of Figures 15a and 15b are attached to the tip portion 71. They may be one-piece with the tip portion as in Figures 14a- 14c, or may be separate therefrom as in Figures 13 a- 13b. A guiding element 92 in an initial, retrieved position holds the proximal ends of the barbs 74. The guiding element - that again may be torus-shaped like in the embodiment of Figs 13 a, 13b, - is slidable with respect to the shaft portion 72 and to the barbs 74. By sliding the guiding element forward, into the distal direction, the barbs are released, and they deploy into the tissue. In many embodiments, the fixation tool 41 for being (permanently) connected to the leaflet like in the embodiment of Figs. 6a-6c has a waist portion and two disc portions, between which the waist portion is arranged. Whereas in the embodiment of Figs. 6a-6c the fixation tool is initially tube-shaped and expands after being released into the named configuration with a waist portion and two disc portions, other embodiments are possible. Especially, it is possible to provide an in-situ assemblable fixation tool 41 as illustrated referring to the figures 16a-20h.

The fixation tool 41 to be attached to the leaflet (the fixation tool may also be referred to as 'proximal anchor) in these embodiments comprise a first part and a second part initially separate from the first part and attachable in situ to the first part. In the following, the first part is referred to as the proximal part and the second part is referred to as distal part. However, the entire configuration can readily be rotated by 180°, i.e. in a different embodiment, the part that is here described as "proximal" part can be arranged to be attached to the leaflet from its distal side, and the "distal part" can be on the proximal side.

The principle is most schematically illustrated in Figures 16a-16d. The fixation tool is implanted using two separate tools or, often preferably, a tool having two jaws that can approach the leaflet from the proximal and the distal side, respectively, and between which the leaflet for example can be temporarily clamped. The proximal part 101 of the fixation tool 41 comprises a proximal disc portion 111 and a shaft 1 12 that forms, after assembly, the waist portion of the fixation tool. In the depicted embodiment, the proximal jaw 121 holds and guides and advances the proximal part 101, whereas the distal jaw 122 holds the distal part 102. In a first step (Fig. 16a), the tool is placed so that the leaflet (which can be temporarily fixated or not, for example by means of a first lumen of the catheter as described hereinbefore) is between the jaws. Then, the leaflet is clamped between the jaws (Fig. 16b). This clamping can serve as temporary fixation and a potential temporary fixation by an other means (such as by suction) can then be relieved. Alternatively, it is possible to use the clamping between the jaws as only temporary fixation, in which case it may be not necessary to provide the catheter with two lumina.

The clamped leaflet is then penetrated (Fig. 16c) by the proximal part 101 that comprises the shaft. The distal end of the fist part may be guided by a guide of the second jaw as will be explained in somewhat more detail hereinafter. The distal part 102 is configured so that it is affixed to the first part after removal of the tool (Fig. 16d), so that the first part and the second part together form the fixation tool 41 with the two disc portions and the waist portion between them.

In the depicted configuration, the artificial chord 32 is shown attached proximally to the fixation tool 41. The chord will thus be guided along the edge of the leaflet into the ventricle. The fact that the leaflet is thereby held in a downward bent orientation is in accordance with the natural position and is desired. In alternative configurations, the artificial chord can also be attached to the distal side of the fixation tool or can be fixed to the proximal or distal side and extend through a central axial opening in the shaft to the respective other side.

Fixation of the fixation tool to the leaflet can be done prior to the anchoring of the anchor in the papillary muscle or thereafter.

The artificial chord may be pre-assembled with the proximal (or in alternative embodiments, distal) fixation tool part, for example by being crimped or welded and/or otherwise fastened to it. Figures 17a-17d show an embodiment of the fixation tool in somewhat more detail. The fixation tool in this embodiment comprises a shaft part 1 12 and a head part 1 1 1 affixed to the shaft part, the shaft part and the head part together forming the first (proximal) fixation tool part. The shaft part and the head part may be loosely or fixedly connected to each other, by reversible or irreversible fixation techniques (crimping, welding etc.) or may, in alternative embodiments, be formed integrally with each other.

The distal part 102 may have a resilient structure - here formed by inwardly projecting lobes - that allows it to be clamped onto the shaft. The shaft may optionally comprise a circumferential groove with which the inwardly projecting resilient structure may engage to provide for an additional fixation security. Figures 17a- 17c show the individual parts, and Fig. 17d shows the device after assembly.

The head part 1 1 1 of the fixation tool forms a first disc portion, and the distal part 102 forms a second disc portion in accordance with the previously discussed concept. As an alternative to being a disc portion, at least one of the flange portions may have an other shape. For example, it may comprise a plurality of fingers, similar to the temporary fixation tool shown in Fig. 8b, or it may have any other suitable shape.

Figures 18a-18d show details of the tip of the catheter 1, 31 by which the fixation tool is attached. Only the tip (the distal end) of the catheter is shown in the figures; the catheter extends from the catheter tip 131 downwards in the orientation according to the figures. In the process described above with reference to Figures 16a-16d, firstly, the catheter is brought into position. Until it is positioned, all parts are stashed within the catheter (Fig. 18a). Then the grabber constituted by the above-described two jaws 121 , 122 is opened (Fig. 18b) by first pushing the distal jaw 122 out of the catheter, as indicated by the arrow. The according pushing tool 132 may have any suitable shape. The leaflet 32 is grabbed by pushing the proximal jaw 121 out of the catheter (Fig. 18c). Then the fixation tool is deployed by pushing the proximal part 101 out so that the shaft 112 penetrates the leaflet.

Figure 19 depicts a detail of an embodiment of the distal jaw. It has an essentially cylindrical body 141 that carries a holder 142. The body may be mounted to the catheter by laser welding. The holder 142 has a structure that guides the proximal anchor after it has penetrated the leaflet in an opening 143 constituted by a tube portion 144. Further the tube portion 144 has the function of keeping the proximal part 102 in an open position to minimize the force necessary to deploy the device.

The tool can optionally be configured so that it is useable only for single-use by being capable of preventing reuse of the device.

Referring to Figures 20a-20h, some optional features that may be advantageous for some embodiments are discussed. Figs. 20a-20h show the tool - with the catheter 1 , 31 shown only in part - again during different stages of the process of fastening the fixation tool 41 to the leaflet. Fig. 20a shows the assembly in somewhat more detail than in Fig. 18b and in section, with the grabber opened.

A first optional feature of the assembly is a needle used to pierce the leaflet prior to penetrating it by the shaft 112. The needle 151 is introduced from the proximal side as shown in Fig. 20b. The needle at the other side - the distal side in the depicted configuration is guided. This gives the overall configuration an increased overall stability and absorbs an angular momentum that would act on the assembly when the fixation tool 41 - or, to be precise, its proximal part in the depicted configuration - is advanced against a resistance that naturally arises when the tissue of the leaflet is penetrated.

The distal jaw 1 12 optionally comprises a latching mechanism that cooperates with the needle to hold the needle 151 distally. The needle after piercing the leaflet is pushed further until a ramp-shaped portion 152 of the needle 151 reaches the latch 154 that is displaced by the needle against the force of a spring and latches behind a retaining portion 153 of the needle (Figs. 20c and 20d).

After the needle has been introduced and is distally guided by the distal jaw (with or without latching mechanism), the proximal fixation tool part 101 is deployed (Fig. 20e) until its distal end is encompassed by the distal fixation tool part 102. Thereafter, the needle may be removed. In the depicted embodiment, the latching mechanism is released by a 180° twist of the needle that causes the retaining portion to be pressed against a side wall of the guide and the needle to thereby displace the latch 154 so that it can be withdrawn (Fig. 20 f). Fig. 20g depicts the configuration with the needle released, and Fig. 20h shows the removal of the tool with the fixation tool 41 remaining affixed to the leaflet (not shown).

A further optional feature, that may be implemented independent of the needle or of other features shown in Figs. 20a-20h is the pushing aside of the holder by the introduction of the proximal fixation tool part. In Figs. 20a-20d the holder 142 is shown in the proximal, initial position where its tube portion 144 keeps the distal fixation tool part opened. As can best be seen in Fig. 20e, the proximal fixation tool portion 101 pushes the holder away into a retracted position. Thereby, the tube portion is pushed out of the distal fixation tool part and the latter clamps onto the shaft of the proximal fixation tool portion. Figures 21a and 21b yet depict a possibility of a guidance portion for the catheter 1, 31 (that again, like in all embodiments dealing with the anchoring of the distal anchor and possibly also in the embodiments dealing with implanting the fixation tool) may be the primary catheter or an inner catheter deployable from the primary catheter). The catheter comprises a grabbing hook 161 that, after the chord 13 has been grabbed (Fig. 21a), may be retracted to form the guidance portion (Fig. 21b). When the distal end portion is guided by the chord 13, as shown in Fig. 21b, the distal anchor may be safely driven into the papillary muscle 15.

A variant of a guiding hook 171 that is arranged near the distal end of the catheter and is not necessarily retractable is shown in Figure 22. Figure 23 yet shows an embodiment with a guidance slot 181 of the catheter's distal end. In the embodiment shown in Figure 23 also - optional suction cups 182 are shown that can be used to temporarily stabilize the catheter 1 , 31 in contact with the papillary muscle when the distal anchor is anchored. Such suction ports can be optionally present in any embodiment in which a catheter (primary catheter or inner catheter) is used to implant the distal anchor in the papillary muscle.

A guidance mechanism that somehow couples to the natural chord (for example by grabbing it) and that may be configured similar to the embodiments shown in Figs 21-23 may also be present directly at the distal anchor in addition or as an alternative to being present at the catheter.

Various other embodiments can be envisaged. For example, other distal anchors than the one based on the harpoon principle illustrated herein may be envisaged, including possibly anchors that fully pierce the papillary muscle and are anchored at an outside of the ventricle. Also, different means of fixing an artificial chord to the leaflet may be used, including tying the chord by known surgical methods such as a knot proximally of the leaflet. Also, the approach according to the invention is not restricted to artificial chords but may also work with other heat valve treatment methods.

While the invention in this text has been described referring to a treatment of the mitral valve, it may also be applicable for treatment of other heart valves, especially of the tricuspid heart valve.

Claims

WHAT IS CLAIMED IS:

A surgical apparatus for treating atrioventricular valve prolapse of the human heart, the apparatus comprising a catheter (1, 31), the apparatus being equipped for temporarily stabilizing a heart valve leaflet (21) during heart beating, the apparatus further comprising a heart valve stabilizer that can be moved forward in the catheter, the heart valve stabilizer comprising an artificial chord (32) for connecting the leaflet (21) to the papillary muscle or other site in the myocardium, an anchor (33) to be anchored in the papillary muscle or other site in the myocardium and equipped for being connected to the artificial chord, and a fixation tool (41) equipped for being connected to the leaflet and to the artificial chord.

The apparatus according to claim 1 , wherein the fixation tool is equipped for being fastened to the leaflet through a perforation of the leaflet.

The apparatus according to claim 2, wherein the fixation tool (41) comprises two flange portions (41.1, 41.2) and a waist portion (41.3) between the flange portions, wherein the waist portion is capable of reaching through the perforation and the flange portions are capable of resting against the superior and inferior surfaces of the leaflet.

The apparatus according to claim 3, wherein the fixation tool comprises a first fixation tool part that comprises a shaft, and a separate second fixation tool part that comprises the second flange portion, wherein the first and second fixation tool parts are equipped for being assembled in situ in a position wherein the shaft penetrates the leaflet, and after assembly constitutes the waist portion. The apparatus according to claim 4, comprising a proximal jaw and a distal jaw, at least the distal jaw being deployable from the catheter, one of the jaws being equipped to hold the first tool part and the other one of the jaws being equipped to hold the second tool part.

The apparatus according to claim 5, further comprising a piercing needle deployable from a first one of the jaws, the needle being positioned and equipped for piercing the leaflet held between the first and the second jaw prior to the introduction of the first fixation tool part.

The apparatus according to claim 6, wherein the needle is positioned and equipped to be guided by the second jaw after leaflet has been pierced.

The apparatus according to claim 7, wherein the second jaw comprises a latch mechanism for holding the needle when it reaches to the second jaw.

The apparatus according to any one of claims 5-8, wherein the one of the jaws that holds the second device part is equipped for guiding the first device part when the same is deployed.

The apparatus according to any one of claims 5-9, wherein the one of the jaws that holds the second device parts comprises a holder for holding the second device part in a release configuration, the holder being displaceable by introduction of the first device part so that the second device part is clamped on the first device part. The apparatus according to any one of the previous claims, wherein the anchor comprises an anchor body and a plurality of pre-shaped barbs and a guiding element that is slidable with respect to the anchor along a proximodistal axis body between a first position and a second position, wherein in the first position the guiding element holds and retains a first portion of the barbs and the anchor body holds and retains a second portion of the barbs, and in the second position the barbs project outward away from the proximodistal axis.

12. The apparatus according to any one of the previous claims, the catheter comprising a first lumen (A) and a second lumen (B), the first lumen comprising a temporary leaflet stabilizer capable of stabilizing the heart valve leaflet (21) during heart beating, wherein the heart valve stabilizer can be moved forward in the second lumen (B), moved out of the second lumen and attached to tissue of the leaflet and to tissue of the papillary muscle or other site in the myocardium.

The apparatus according to claim 12, wherein the temporary leaflet stabilizer comprises a vacuum system, wherein the first lumen is connected to a suction device, and wherein the leaflet stabilizer is capable of stabilizing the heart valve leaflet by an applied vacuum.

14. The apparatus according to any one of claims 12 or 13 further comprising an inner steerable catheter (31) that can be deployed from the second lumen (B) and houses the heart valve stabilizer or parts thereof.

15. The apparatus according to any one of the previous claims, wherein the anchor (33) has barb structures.

16. The apparatus according to any one of the previous claims further comprising a tissue proximity detector device (5) that detects whether a leaflet (21) is close to the first lumen.

17. The apparatus according to claim 16 comprising a vacuum system with a suction device to which the first lumen is connected, wherein the proximity detector device is operable to activate the suction device when the leaflet is close to the suction port.

The apparatus according to any one of the previous claims, wherein at least one of the anchor (33) and of a distal anchor placement device comprises a guidance portion capable of coupling to a natural chord to guide the anchor to the papillary muscle.

A surgical method of treating a heart valve comprising the steps of providing a catheter with a first lumen and a second lumen, moving a distal end of the catheter to approach a leaflet of the heart valve, when the distal end of the catheter has approached the leaflet, stabilizing the leaflet with a grasping mechanism applied via the first lumen to temporarily stabilize the leaflet, deploying a working tool from the second lumen and using the working tool to treat the heart valve, and de-activating the stabilizing mechanism and removing the catheter. The method according to claim 19, wherein the step of stabilizing the leaflet with a grasping mechanism is a step of turning on a suction force through the first lumen to grasp the leaflet by a suction force and the step of de-activating the stabilizing mechanism may be a step of turning off the suction force.

21. A surgical method of treating a heart valve, comprising the steps of:

• providing a catheter;

• moving a distal end of the catheter to approach a leaflet of the heart valve; when the distal end of the catheter has approached the leaflet, temporarily stabilizing the leaflet; · fastening an anchor of a heart valve stabilizer to the papillary muscle of the heart's ventricle;

• perforating the temporarily stabilized leaflet to yield a perforation;

• fastening a fixation tool to the temporarily stabilized leaflet so that the fixation tool reaches through the perforation; · wherein the fixation tool and the anchor are connected to an artificial chord; and

• de-activating the stabilizing mechanism and removing the catheter; wherein the steps of fastening the anchor to papillary muscle and of fastening the fixation tool to the leaflet are carried out in arbitrary sequence. The method according to claim 21 , wherein in the step of fastening the anchor to the papillary muscle the anchor is guided by a natural chord attached to the papillary muscle.

The method according to claim 21 or 22, wherein the step of perforating the leaflet is carried out by a needle, and wherein the fixation tool is caused to penetrate the leaflet through the perforation after the step of perforating.

The method according to claim 23, wherein the needle comprises a first end with a needle tip and a second end, and wherein the needle is kept in a position in which it penetrates the leaflet and in which both, the first and the second end are mechanically stabilized while the fixation tool is caused to penetrate the leaflet.

The method according to any one of claims 23 or 24, wherein the fixation tool is cannulated and wherein the needle guides the fixation tool by being in the cannulation of the fixation tool while the fixation tool is caused to penetrate the leaflet.

An anchor (33) for being anchored in the papillary muscle to provide an anchor for an artificial chord in a treatment of atrioventicular valve prolapse in the human heart, for example in an apparatus according to any one of claims 1-16, the anchor comprising an anchor body the anchor further comprising a plurality of pre-shaped barbs and a guiding element that is movable with respect to the anchor body between a first position and a second position, wherein in the first position the guiding element holds and retains a first portion of the barbs and the anchor body holds and retains a second portion of the barbs, and in the second position the barbs project outward away from the proximodistal axis.

27. The anchor according to claim 26, wherein the anchor body comprises a distal tip portion and a shaft portion proximally of the tip portion, wherein the guiding element is slidable along the shaft portion in direction of the proximodistal axis..

28 The anchor according to claim 26 or 27, wherein the first portion of the barbs that is held and retained by the guiding element is proximal of the second portion, and wherein the barbs are connected to the guiding element and are slidable with respect to the anchor body.

29 The anchor according to claim 28, wherein the barbs are mounted to be pushed out of holes in the anchor body, which holes are open to the distal side, and wherein the barbs are pre-shaped to bend from a distal direction away from the anchor body.

30 The anchor according to claim 26 or 27, wherein the barbs are connected to the anchor body, wherein the guiding element is slidable also with respect to the barbs, and wherein in the second position a proximal end of the barbs is bent away from the anchor body.

31. The anchor according to any one of claims 26-30, wherein the barbs are made of a shape memory material. A fixation tool for being affixed to a leaflet of an atrioventicular heart valve, for example in an apparatus according to any one of claims 1 -18 and/or for example in a surgical apparatus further comprising an anchor according to any one of claims 26-31 , the fixation tool being equipped for being affixed to an artificial chord in a treatment of atrioventricular heart valve prolapse in the human heart, the fixation tool comprising a first flange portion, a second flange portion, and a waist portion between the flange portions, wherein at least one of the following conditions is fulfilled:

The fixation tool is made of a shape memory metal, is capable of being held in a preliminary shape with a first maximum outer transversal diameter, and upon being released expands into a final shape that comprises the first and second flange portions and the waist portion, wherein in the final shape the fixation tool has a second maximum transversal outer diameter, the second maximum transversal outer diameter being greater than the first maximum transversal outer diameter;

The fixation tool comprises a first fixation tool part that comprises a shaft, and a separate second fixation tool part that comprises the second flange portion, wherein the first and second fixation tool parts are equipped for being assembled in situ from in a position wherein the shaft penetrates the leaflet, and after assembly constitutes the waist portion.

An apparatus for treating atrioventicular valve prolapse of the human heart during heart beating, the apparatus comprising a catheter (1, 31), and further comprising a fixation tool according to claim 32 deployable from the catheter.

34. The apparatus according to claim 33, comprising a proximal jaw and a distal jaw, at least the distal jaw being deployable from the catheter, one of the jaws being equipped to hold the first device part and the other one of the jaws being equipped to hold the second device part.

The apparatus according to claim 34, further comprising a piercing needle deployable from a first one of the jaws, the needle being positioned and equipped for piercing the leaflet held between the first and the second jaw prior to the introduction of the first fixation tool part.

The apparatus according to claim 35, wherein the needle is positioned and equipped to be guided by the second jaw after leaflet has been pierced.

The apparatus according to claim 36, wherein the second jaw comprises mechanism for holding the needle when it reaches to the second jaw.

The apparatus according to any one of claims 34-37, wherein the one of the jaws that holds the second device part is equipped for guiding the first device part when the same is deployed.

The apparatus according to any one of claims 34-38, wherein the one of the jaws that holds the second device parts comprises a holder for holding the second device part in a release configuration, the holder being displaceable by introduction of the first device part so that the second device part is clamped on the first device part.