CN103987341A

CN103987341A - Apparatus and method for treating a regurgitant heart valve

Info

Publication number: CN103987341A
Application number: CN201280011750.8A
Authority: CN
Inventors: J·L·纳维亚
Original assignee: Cleveland Clinic Foundation
Current assignee: Cleveland Clinic Foundation
Priority date: 2011-01-04
Filing date: 2012-01-04
Publication date: 2014-08-13
Anticipated expiration: 2032-01-04
Also published as: CN103987341B; JP5695213B2; JP2014506175A

Abstract

An apparatus (10) is provided for treating regurgitation of blood flow through a diseased heart valve. The diseased heart valve includes an annulus, anterior and posterior valve leaflets, and a subvalvular apparatus. The apparatus includes a substantially annular support member (40) and at least one infra - annular support member (42) securely connected thereto. The substantially annular support member has at least a first intermediate portion, a second intermediate portion, and a posterior end portion extending between the first and second intermediate portions. The posterior end portion is dimensioned for attachment to a posterior portion of the annulus of the diseased heart valve. The at least one infra - annular support member is securely connected to the substantially annular support member at a first location. The at least one infra - annular support member is dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind at least one subvalvular structure.

Description

The apparatus and method that treatment cardiac valve backflows

The cross reference of related application

That the application requires is that on January 4th, 2011 submits to, serial number is No.61/429, the priority of 543 U.S. Provisional Patent Application, and the main contents of this application are by reference to being herein incorporated.

Technical field

The present invention relates generally to the apparatus and method that are used for the treatment of the function of heart valve obstacle, more particularly, relate to that one provides under lobe (sub-valvular) thus lobe leaf supports and lobe lower device supports in passive mode and helps prevent or alleviate the apparatus and method that cardiac valve backflows.

Background technology

Valvular opening and closing are mainly to occur because pressure is different.For example, mitral opening and closing are to occur because the pressure between left atrium and left ventricle is different.At the relaxing period of ventricle, the venous return that enters the blood of left atrium from pulmonary vein causes the pressure of left atrium to exceed the pressure of left ventricle.Therefore, Bicuspid valve is opened and is allowed blood to enter left ventricle.Due to left ventricular contraction in the process of ventricular systole, therefore make the pressure of ventricle inside be increased to the pressure higher than inside, atrium, and promote MC.

In the time that the high pressure being produced by the contraction of left ventricle exceedingly promotes valve lobe leaf, can cause lobe leaf to overturn and prolapse.Under normal circumstances, can prevent by the contraction of the papillary muscle in left ventricle the generation of this phenomenon, this papillary muscle is connected with mitral leaflet by chordae tendineae (chords).The contraction of papillary muscle and the contraction of left ventricle are simultaneous, thereby make healthy mitral leaflet can keep closing in the time of systolic pressure peak value.

Different types of etiopathogenises can cause Bicuspid valve to lose efficacy.For example, the reason of mitral reflux from the intrinsic disease of lobe leaf (for example can extensively arrive, mainly due to patient's the degenerative disease (degenerative disease) of suffering from mitral valve prolapse) to Functional mitral regurgitation (FMR), in Functional mitral regurgitation, although the anatomical structure of valve is normal, can be because of constraint and annular expansion (tethering and annular dilatation) impaired (stretched).Although the mitral reflux in intrinsic disease is rendered as lobe leaf disease at first, there is the expansion of secondary annular in most patient in the time for the treatment of.The most patient who suffers from mitral reflux comprises that those do not suffer from the patient of the intrinsic disease of lobe leaf, the namely patient of those Functional mitral regurgitations (FMR).

The overcorrection that the corrective procedure of Functional mitral regurgitation (FMR) expands taking the annular of being followed is basis, utilize valvoplasty ring reduced size, complete, rigidity (annuloplasty ring), engage to realize reducing the diameter of annulus of mitral valve and being allowed for lobe leaf.Although proved that by operation mitral reflux can be corrected completely, but because left atrium expands or distortion can cause the further constraint of mitral leaflet constantly, therefore after valvoplasty reparation, a large amount of recurrences (25%) of common mitral reflux.

Summary of the invention

According to an aspect of the present invention, providing a kind of is used for the treatment of by the device of the blood reflux of diseased heart valve.Described diseased heart valve comprises organ under valve annulus, anterior valve lobe leaf, rear portion valve lobe leaf and lobe.Described device comprises support member and at least one ring lower support element of general toroidal, and described ring lower support element is connected securely with the support member of described general toroidal.The support member of described general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, and described rearward end is extended between described the first pars intermedia and described the second pars intermedia.Described rearward end is set to the rear portion of the described valve annulus that is connected to described diseased heart valve.Described ring lower support element is connected to the support member of described general toroidal securely in primary importance.Described at least one ring lower support element be set to be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and extend, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.

According to a further aspect in the invention, providing a kind of is used for the treatment of by the device of the blood reflux of diseased heart valve.Described diseased heart valve comprises organ under valve annulus, anterior valve lobe leaf, rear portion valve lobe leaf and lobe.Described device comprises support member, first ring lower support element and the second ring lower support element of general toroidal.The support member of described general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, and described rearward end is extended between described the first pars intermedia and described the second pars intermedia.Described rearward end is set to the rear portion of the described valve annulus for being connected to described diseased heart valve.Described first ring lower support element is connected to the support member of described general toroidal securely in primary importance.Described the second ring lower support element is connected to the support member of described general toroidal securely in the second position.Described first ring lower support element and described the second ring lower support element be set to be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and extend, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.

According to a further aspect in the invention, providing a kind of is used for the treatment of by the method for the blood reflux of diseased heart valve.Described diseased heart valve comprises organ under valve annulus, anterior valve lobe leaf, rear portion valve lobe leaf and lobe.A step of described method comprises provides step, at least one the ring lower support element that provides a kind of device, this device to comprise the support member of general toroidal in this step and be connected securely with the support member of described general toroidal.The support member of described general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, and described rearward end is extended between described the first pars intermedia and described the second pars intermedia.Then, the step of described method comprises Connection Step, the support member of described general toroidal is connected to the described valve annulus of described diseased heart valve in this step, make described at least one ring lower support element be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend, to prevent or roughly to reduce by the blood reflux of diseased heart valve.

Brief description of the drawings

By reading the description referring to accompanying drawing, for the technical staff in field involved in the present invention, above and other feature of the present invention will become obviously, wherein:

Figure 1A is the axonometric chart through the device of Bicuspid valve blood reflux that is used for the treatment of constructed according to an aspect of the present invention;

Figure 1B is the top view that is implanted to the device in ill mitral Figure 1A;

Fig. 1 C shows the top view of being convenient to device 10 to be connected to the device in Figure 1A of labelling of annulus of mitral valve;

Fig. 1 D is the side view of the device in Figure 1A;

Fig. 1 E is the cutaway view of cutting open along the 1E-1E line in Fig. 1 D;

Fig. 1 F is the top view that shows the alternative structure of the device in Figure 1B;

Fig. 1 G is the top view of the alternative structure of the device in displayed map 1F;

Fig. 1 H is the perspective view of included its a part of governor motion of conduct of the device in demonstration Figure 1A;

Fig. 1 I is the side view of the device in Fig. 1 H of mode of operation of the governor motion in displayed map 1H;

Fig. 1 J is the top view of the device in Fig. 1 I of mode of operation of vision-control mechanism;

Fig. 1 K is the cutaway view that the percutaneous of the device in displayed map 1J regulates the human heart of (percutaneous adjustment);

Fig. 2 is the cutaway view that shows the left side of human heart;

Fig. 3 A is the axonometric chart that shows the alternative structure of the device in Figure 1A;

Fig. 3 B shows the top view that is implanted to the device in ill mitral Fig. 3 A;

Fig. 3 C is the axonometric chart of the alternative structure of the device in displayed map 3A;

Fig. 3 D shows the top view that is implanted to the device in ill mitral Fig. 3 C;

Fig. 4 A is the top view that shows the alternative structure that is implanted to the device in ill mitral Figure 1A;

Fig. 4 B is the axonometric chart of the device in Fig. 4 A;

Fig. 4 C shows the cutaway view that is implanted to the device in ill mitral Fig. 4 A-Fig. 4 B;

Fig. 4 D shows the axonometric chart that is implanted to the device in ill mitral Fig. 4 A-Fig. 4 B;

Fig. 4 E is the mitral annular of reinventing in displayed map 4C-Fig. 4 D and the schematic diagram that encircles lower horizontal plane (levels);

Fig. 5 A is the axonometric chart of the alternative structure of the device in displayed map 4A-Fig. 4 B;

Fig. 5 B is the axonometric chart of the another kind of alternative structure of the device in displayed map 5A;

Fig. 6 A is the axonometric chart that shows the alternative structure of the device in Figure 1A;

Fig. 6 B is the axonometric chart of the alternative structure of the device in displayed map 6A;

Fig. 6 C is the axonometric chart of the another kind of alternative structure of the device in displayed map 6A;

Fig. 7 A is the top view that shows the alternative structure of the device in Figure 1A;

Fig. 7 B is the three-dimensional view of the device in Fig. 7 A;

Fig. 7 C is the side view of the device in Fig. 7 A-Fig. 7 B;

Fig. 8 A is the axonometric chart of the measuring appliance constructed according to a further aspect in the invention;

Fig. 8 B is the side view of the amplification of the end portion of the measuring appliance in displayed map 8A;

Fig. 8 C is the top view that comprises the measurement component of the measuring appliance in Fig. 8 A;

Fig. 8 D shows the top view that is connected to the device in the Figure 1A that transmits utensil or support member;

Fig. 8 E shows the amplification stereogram that is connected to the transmission utensil of the device in Figure 1A or the part of support member (Fig. 8 D);

Fig. 9 A shows the axonometric chart that is implanted to the device in ill mitral Fig. 7 A;

Fig. 9 B is the cutaway view installing in Fig. 9 A;

Fig. 9 C is the cutaway view of demonstration along rear support parts under the ring of the device in Fig. 9 B of the lower free margins extension of posterior mitral valve leaflet (the posterior mitral leaflet);

Figure 10 A is the axonometric chart of the alternative structure of the device in displayed map 7A-Fig. 7 B;

Figure 10 B shows the axonometric chart that is implanted to the device in ill mitral Figure 10 A;

Figure 11 A is the axonometric chart of the alternative structure of the device in displayed map 7A-Fig. 7 B;

Figure 11 B shows the axonometric chart that is implanted to the device in ill mitral Figure 11 A;

Figure 12 A is the axonometric chart of the alternative structure of the device in displayed map 7A-Fig. 7 B;

Figure 12 B is the side view of the device in Figure 12 A;

Figure 12 C shows the axonometric chart that is implanted to the device in ill mitral Figure 12 A-Figure 12 B;

Figure 13 A is the plane graph of the alternative structure of the device in displayed map 7A-Fig. 7 B;

Figure 13 B is the side view of the device in Figure 13 A;

Figure 14 A is the top view through the device of tricuspid blood reflux that is used for the treatment of constructed according to a further aspect in the invention;

Figure 14 B is the perspective view of the device in Figure 14 A;

Figure 14 C is the side view of the device in Figure 14 A;

Figure 14 D is the axonometric chart of the alternative structure of the device in displayed map 14A;

Figure 14 E is the axonometric chart of the another kind of alternative structure of the device in displayed map 14A;

Figure 15 is the cutaway view of human heart;

Figure 16 A shows the axonometric chart that is implanted to the device in ill tricuspid Figure 14 A;

Figure 16 B is the axonometric chart of the tricuspid bottom outward appearance (inferior aspect) in displayed map 16A;

Figure 17 A is the axonometric chart of the alternative structure of the device in displayed map 14A;

Figure 17 B is the axonometric chart that is implanted to the device in ill tricuspid Figure 17 A;

Figure 17 C is the axonometric chart of the tricuspid bottom outward appearance in displayed map 17B;

Figure 17 D is the axonometric chart of the alternative structure of the device in displayed map 17A;

Figure 17 E is the axonometric chart of the another kind of alternative structure of the device in displayed map 17A;

Figure 18 A is the axonometric chart of the alternative structure of the device in displayed map 14A;

Figure 18 B is the axonometric chart of the alternative structure of the device in displayed map 18A; And

Figure 18 C is the axonometric chart of the another kind of alternative structure of the device in displayed map 18B.

Detailed description of the invention

The present invention relates generally to the apparatus and method that are used for the treatment of the function of heart valve obstacle, more particularly, a kind of sub-valve lobe leaf support and sub-valve device of providing is provided and supports to help prevent passively or alleviate the apparatus and method that cardiac valve backflows.The present invention provides a kind of valvoplasty loop systems conventionally, and lobe leaf and valve lower device supporting mechanism that this system has the lower part (infra-annular) of ring, free margins fetter and backflow to prevent heart contraction process mesopetalum leaf.Advantageously; the invention provides synchronous annular and the ring lower horizontal plane of the heart reconstruction of cardiac valve (Bicuspid valve and Tricuspid valve), so that the horizontal plane of lobe leaf seam and correctization of angle and normalization, prevent lobe leaf constraint and eliminate valvular regurgitation through the problem of recurrence after a while.Therefore, treatment provided by the invention is not only for valvular regurgitation (such as Functional mitral regurgitation), also for the valvular regurgitation causing because of dilated cardiomyopathy and ischemic cardiomyopathy.

As the representative of one aspect of the present invention, Figure 1A-Fig. 1 E has illustrated and has been used for the treatment of through such as Bicuspid valve 12(Fig. 2) the device 10 of blood reflux of diseased heart valve.As shown in Figure 2, Bicuspid valve 12 is between left atrium 14 and left ventricle 16, and for stoping heart contraction process to enter the blood back flow of left atrium from left ventricle.Mitral valve 12 has D shape ring 18, these D shape ring 18 openings that defined between left atrium 14 and left ventricle 16, and Bicuspid valve 12 comprises front portion 20 and the rear portion 22 of positioned opposite.Bicuspid valve 12 is by two leaf one-tenth of lobe, that is, anterior lobe leaf 24 and rear portion lobe leaf 26, each lobe leaf comprises upper face 28 and the lower surface 30 of positioned opposite.Anterior lobe leaf 24 extends between two fibrous triangle (not shown) along the planar base roughly of D shape annulus of mitral valve 18.Rear portion lobe leaf 26 extends with circular arc around the curved portion of the D shape annulus of mitral valve 18 of Bicuspid valve 12.Chordae tendineae 32 and chordae tendineae 32 ' respectively the lower free margins 34 of anterior mitral leaflet 24 and the lower free margins 36 of rear portion mitral leaflet 26 to the papillary muscles 38 of left ventricle 16 and papillary muscles 38 ' between extend.

With reference to Figure 1A-Fig. 1 E, device 10 comprises the support member 40 of general toroidal and is securely connected at least one ring lower support element of this support member 40 (such as the lower back support member 42 of ring).Device 10 has the three-dimensional corresponding with the saddle type shape of annulus of mitral valve 18 (3D) shape.In the complicated physiological movement process relevant to cardiac cycle, the 3D shape of device 10 makes device 10 can compensate the 3D shape of Bicuspid valve 12.Like this, for example be implanted in annulus of mitral valve 18 or be implanted on annulus of mitral valve 18 when device 10 being implanted to Bicuspid valve 12() time, can be because installing 10 demands of eliminating Valvectomy and/or circular folding art, thereby help to provide lobe leaf to support in passive mode, make can not deform in the process of cardiac cycle.

The support member 40 of general toroidal at least comprises the first pars intermedia 44, the second pars intermedia 46 and the rearward end 48 of extending between the first pars intermedia 44 and the second pars intermedia 46.Term " general toroidal " used herein can be for describing the annular support member 40 with circle or semicircular structure.Therefore, to refer to annular support member 40 be annular, circle, ellipse, part circular, C shape, D shape, U-shaped etc. completely completely to term " general toroidal ".Term " roughly " used herein can refer to the complete of action, feature, performance, state, structure, project, result or approach complete scope or degree.For example, annular support member 40 is the annular of " roughly ", means that this support member is complete annular or approaches complete annular.Definite admissible deformation extent compared with absolute annular may depend on specific linguistic context.But in general, compared with the result obtaining with absolute and complete annular, approximate annular will have identical whole structure.

As shown in Figure 1A-Fig. 1 C, the support member 40 of general toroidal can be complete annular, and comprises: the first pars intermedia 44; The second pars intermedia 46; Rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46; And leading section 50, this leading section 50 extends between the first pars intermedia 44 and the second pars intermedia 46, and with rear, end 48 is relatively arranged.Alternately, as shown in Fig. 1 F-Fig. 1 G, the support member 40 of general toroidal can be part annular, and comprises: the first pars intermedia 44; The second pars intermedia 46; And rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46.

Leading section 50 and rearward end 48 are set to be connected to respectively front portion 20 and the rear portion 22 of annulus of mitral valve 18.For example, rearward end 48, the first pars intermedia 44, the second pars intermedia 46 form continuous arc, thereby make rearward end 48 have concave shape with respect to leading section 50.Similarly, leading section 50, the first pars intermedia 44, the second pars intermedia 46 form continuous arc, thereby make leading section 50 have convex shape with respect to rearward end 48.As shown in Fig. 1 D, the support member 40 of general toroidal also comprises longitudinal axes L A.The support member 40 of general toroidal can have structure rigidity or semirigid.

Device 10 also comprises the lower back support member 42 of at least one ring, and the lower back support member 42 of ring is directly connected to the support member of general toroidal securely in primary importance 52.For example, as shown in Figure 1A-Fig. 3 B, device 10 only includes back support member 42 under a ring.When device 10 is implanted on annulus of mitral valve 18 or while being implanted to around annulus of mitral valve 18, size, shape and the structure of the lower back support member 42 of ring is set to below rear portion mitral leaflet 26 and extends, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.Under the lobe relevant to Bicuspid valve 12, structure includes but not limited to: the bottom outward appearance of rear portion lobe leaf 26, such as the lower free margins 36 of rear portion lobe leaf 26; The bottom outward appearance of anterior lobe leaf 24, such as the lower free margins 34 of anterior lobe leaf 24; Chordae tendineae 32, this chordae tendineae 32 is relevant to rear portion lobe leaf 26; Chordae tendineae 32 ', this chordae tendineae 32 ' relevant to anterior lobe leaf 24; One or more papillary muscles 38, this papillary muscles 38 is relevant to the chordae tendineae 32 of rear portion lobe leaf 26; One or more papillary muscles 38 ', this papillary muscles 38 ' to the chordae tendineae 32 of anterior lobe leaf 24 ' relevant; And joint portion.

Shape, structure, the size of the lower back support member 42 of ring can be set to extend through following structure or at the rear of following structure: structure under the lobe of structure or two or more a part under the lobe of structure under structure under single complete lobe, two or more complete lobe, a single part.For example, the structure of the lower back support member 42 of ring can be configured to below rear portion mitral leaflet 26 and extend, and through the part of the lower free margins 36 of rear portion mitral leaflet 26 or be positioned at the lower free margins 36 of rear portion mitral leaflet 26 a part rear and extend, alternately, only extend through a part for the lower free margins 36 of rear portion mitral leaflet 26 or be only positioned at the lower free margins 36 of rear portion mitral leaflet 26 a part rear and extend.In addition, the lower back support member 42 of ring can be configured to below rear portion mitral leaflet 26 and extend, and one or more through complete chordae tendineae 32 and/or the papillary muscles 38(relevant to rear portion mitral leaflet 26) or be positioned at complete chordae tendineae 32 and/or the papillary muscles 38(relevant with rear portion mitral leaflet 26 one or more) rear and extending, alternately, through the part of the chordae tendineae 32 of rear portion mitral leaflet 26 or be positioned at the chordae tendineae 32 of rear portion mitral leaflet 26 a part rear and extend.In these cases two kinds or wherein under a kind of situation, the shape of the lower back support member 42 of ring has reflected the 3D shape of rear portion mitral leaflet 26, especially the 3D shape of the lower free margins 36 of rear portion mitral leaflet 26, to prevent or to slow down the action of rear portion mitral leaflet 26 limited, and prevent conversely, or slow down backflowing through the blood of Bicuspid valve 12.

As shown in Fig. 1 D, the lower back support member 42 of ring extends below the longitudinal axes L A of the support member 40 of general toroidal with angle A and distance B.The angle A of the lower back support member 42 of ring makes to encircle lower back support member 42 and can promote best lobe leaf to engage.In one embodiment of the invention, angle A can be between about 10 ° to about 60 ° (such as about 30 °).Similarly, distance B can make to encircle lower back support member 42 extends below rear portion mitral leaflet 26, can promote best lobe leaf to engage thereby make to encircle lower back support member 42.

The lower back support member 42 of ring can have rigidity or semirigid structure.For example, in the time that the lower back support member 42 of ring has semirigid structure, the lower back support member 42 of ring flexible to or can be adjusted to diverse location.The lower back support member 42 of ring can comprise governor motion 54(Fig. 1 H-Fig. 1 K extraly or optionally), governor motion 54 optionally under adjustable ring back support member 42 with respect to the position of longitudinal axes L A.As shown in Figure 1 I, before device 10 is implanted, in and/or afterwards, governor motion 54 allows angle A and/or distance B and/or the lateral attitude LP of back support member 42 under adjustable ring optionally.

Engage in order to improve lobe leaf, can according to organ structure under lobe leaf tissue structure, lobe (such as chordae tendineae 32 and chordae tendineae 32 ' and papillary muscles 38 and papillary muscles 38 ') and/or free sidelobe leaf engagement angles, optionally regulate encircling the angle A of lower back support member 42 and/or distance B and/or lateral attitude LP.Lateral attitude LP refers to the position of the lower back support member 42 of ring with respect to the direction of axle rearward end 48 and edge parallel with longitudinal axes L A (or almost parallel) of the support member 42 of general toroidal.As shown in Fig. 1 J, can operate governor motion 54 so that the lateral attitude LP of the lower back support member 42 of ring is adjusted to default position (indicated by arrow and dotted line).For example, device 10 can comprise three default positions (indicated by " 1 " " 2 " " 3 ").Understandably, can operate governor motion 54 so that angle A and/or the distance B of the lower back support member 42 of ring are adjusted to preset position.

In one embodiment of the invention, governor motion 54 can comprise that actuator 56(is as shown in Fig. 1 H and Fig. 1 J), such as being at least partially disposed in the support member 40 of general toroidal and may be operably coupled to the screw (such as ratchet-like mechanism) of the lower back support member 42 of ring.Can optionally operate (such as rotating, push away, draw etc.) actuator 56 to regulate angle A and/or distance B and/or the lateral attitude LP of (such as increasing or reducing) the lower back support member 42 of ring.

Can be by adjustment means 58(Fig. 1 I-Fig. 1 K) optionally regulate actuator 56.The structure of adjustment means 58 will depend on the opportunity that needs the position of back support member 42 under adjustable ring.For example, need the position of back support member 42 under adjustable ring in cardiac surgical procedure time, can be similar screw-driven part or other similar parts by the Structural Tectonics of adjustment means 58, thereby surgeon be can be easily hand-held and operate (Fig. 1 J).Alternately, need the position of back support member 42 under adjustable ring after implanting device 10 time, can be conduit by the Structural Tectonics of adjustment means 58, thereby allow to carry out percutaneous adjusting (Fig. 1 I and Fig. 1 K) to encircling lower back support member 42.

In general, in the cardiac surgical procedure under direct-view, can be by using percutaneous crossedpath (Fig. 1 K), use electromagnetic force (description below) and/or under echocardiographic guiding, optionally operating actuator 56.For example, adjustment means 58 can be connected to actuator 56 and by indwelling (be left) by magnetic force, and pass left side atrial walls and externalizing (externalized), thereby, after departing from the extracorporeal circulation stage (after coming off cardiopulmonary bypass), can carry out under adjustable ring back support member 42(such as under echocardiographic guiding by operation actuator), to obtain the best angle that lobe leaf engages and therefore to eliminate Bicuspid valve and/or Tricuspid valve backflows.After this, can interrupt described magnetic force and remove adjustment means 58.

Be understandable that, governor motion 54 can have the structure of back support member 42 under other optionally adjustable ring.For example, the lower back support member 42 of ring whole or only a part can be made up of shape-memory material, thereby can be by optionally energy being applied thereto to the shape (and direction) that regulates this shape-memory material.If recurred along with passage of time Bicuspid valve and/or SAN GUAN lobe backflow, governor motion 54 can advantageously allow position to encircling lower back support member 42 to regulate and without implementing extra operation on heart.

The lower back support member 42(Fig. 1 C of ring) comprise junction surface 60 and the cervical region 62 being integrally formed, cervical region 62 extends to primary importance 52 from junction surface 60.Junction surface 60 is configured to contact with structure under at least one lobe, and generally has elongated S shape structure.Bonding part 60 can have circular cross-sectional profile, V-arrangement cross-sectional profiles, oval cross section profile, square cross-sectional profiles or the cross-sectional profiles of other geometries arbitrarily.Junction surface 60 can have the structure of arc.For example, as shown in Figure 1 C, junction surface 60 can have convex shape with respect to the rearward end of the support member of general toroidal 40 48.

Cervical region 62 forms with junction surface 60.Cervical region 62 is set between this joint close position, extending between the joint close position of the corresponding one of mitral leaflet 24 and mitral leaflet 26 or approx.Like this, primary importance 52 typically but optionally with the joint close position of mitral leaflet 24 and mitral leaflet 26 in one adjacent.As shown in Figure 1B-Fig. 1 C, cervical region 62 comprises the first end 64 and the second end 66 that are oppositely arranged, first end 64 and the second end 66 respectively with the support member 40(of general toroidal such as in primary importance 52) and junction surface 60 form.For example, the first end 64 of cervical region 62 forms with the second pars intermedia 46 of the support member 40 of general toroidal.

Device 10 whole or only a part are made up of rigidity or semi-rigid material, and this material can allow manual distortion, and still enough hardly after implantation be out of shape to bear further (such as, in the time suffering normal physiological stress).The nonrestrictive example that is used for the material of constructing apparatus 10 can comprise biocompatibility medical metal, such as metal alloy, plastics, Nitinol, rustless steel, titanium, RESEARCH OF PYROCARBON, cochrome etc.

Can be by the whole of cover layer 68 cladding systems 10 of biocompatible materials or a part (Fig. 1 E) only.The cover layer 68 of biocompatible materials can comprise synthetic material, such as, terylene (DACRON), braiding velvet, polyurethane, politef, expanded PTFE or heparin coating fiber etc.Alternately, cover layer 68 can comprise biomaterial, as the pericardium of cattle or horse, alloplast, sick body graft or cell construction tissue.Cover layer 68 can cover the support member 40 of general toroidal and/or the inner surface of the lower back support member 42 of ring, the support member 40 of general toroidal and/or the outer surface of the lower back support member 42 of ring, or can be wound around around described inner surface and described outer surface.For example, as shown in Fig. 1 E, cover layer 68 can be arranged to the whole circumference around the support member 40 of general toroidal.Be understandable that any part that cover layer 68 can cladding system 10.

Equally as shown in Figure 1 C, cover layer 68 can comprise at least one labelling 70, to be conducive to that device 10 is connected to annulus of mitral valve 18.Labelling 70 can comprise preform hole, to be conducive to sewing up location and/or color instruction, thereby indicates suture location so that the device 10 in organic live body obtains firmly.Be understandable that, can in the horizontal plane of trigonum, (at the level of the trigones) (not shown) be amplified or be strengthened by a part for device 10, so that the extra biocompatibility cover layer around desired part (one or more) promotes to implant and lobe leaf engages by introducing.

Can process installing at least a portion of 10 with the healing potion that can eluting (eluting) enters one or more combinations of chambers of the heart chamber or cardiac muscular tissue.Healing potion can prevent multiple pathological state, includes but not limited to arrhythmia, thrombosis, valvular stenosis, apoptosis and inflammation.Correspondingly, healing potion can comprise at least one in arrhythmia medicament, anticoagulant, antioxidant, fibrinolytic, steroid, anti-apoptosis medicament, anti-undue growth medicament (, can prevent epithelial cell undue growth) and/or antibiotic medicine.Alternatively or additionally, other diseases or lysis can be treated or prevent to healing potion, such as infected by microbes and heart failure.In these examples, healing potion can comprise Antimicrobial agent (such as, antibiotic), cardiac tonic, chronotropic medicament and/or the biological preparation such as cell or albumen etc.

Fig. 3 A-Fig. 3 D has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Fig. 3 A-Fig. 3 D _aidentical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 3 A-Fig. 3 D, the structure identical with structure in Figure 1A-Fig. 1 I used identical Reference numeral, and with structural similarity in Figure 1A-Fig. 1 I but the not identical subsidiary subscript " a " of structure.Be understandable that device 10 _acan be formed by any above-described material, and device 10 _acan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

As shown in Fig. 3 A-Fig. 3 B, the lower back support member 42 of ring _acan there is bifurcation structure, comprise the first junction surface 72 and the second junction surface 74 that arrange at intervals.The first junction surface 72 and the second junction surface 74 can be spaced apart, and are axially offset (with respect to central shaft CA) distance B 1(Fig. 3 A each other).In general particular valve incompetence and other factors that, distance B 1 can suffer from according to Bicuspid valve anatomical structure, patient change.Especially, distance B 1 can be changed to and promote contacting between structure under the first junction surface 72 and the second junction surface 74 and one or more lobe.For example distance B 1 can change to make the first junction surface 72 to contact a part for the lower free margins 36 of rear portion mitral leaflet 26, and make the second junction surface 74 contact a part for chordae tendineae 32 and/or the papillary muscles 38(relevant to rear portion mitral leaflet 26 one or more).

As shown in Fig. 3 C-Fig. 3 D, the lower back support member 42 of ring alternatively can have arc, loop configuration, and this loop configuration comprises the hole 134 through this extensibility of structure.The junction surface 60 of the lower back support member 42 of ring can have concave shape with respect to the leading section of the support member of general toroidal 40 50.In addition, the junction surface 60 of the lower back support member 42 of ring can be through the whole of structure under at least one lobe or a part and extending only, or is positioned at the rears whole or an only part of structure under at least one lobe and extends.

Fig. 4 A-Fig. 4 E has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Fig. 4 A-Fig. 4 E _bidentical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 4 A-Fig. 4 E, the structure identical with structure in Figure 1A-Fig. 1 I used identical Reference numeral, and with structural similarity in Figure 1A-Fig. 1 I but the not identical subsidiary subscript " b " of structure.Be understandable that device 10 _bcan be formed by any above-described material, and device 10 _bcan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

As shown in Fig. 4 A-Fig. 4 B, the lower back support member 42 of ring _bcan there is bifurcation structure, comprise the first junction surface 72 and the second junction surface 74 that arrange at intervals.The first junction surface 72 and the second junction surface 74 can be spaced apart, and are radially offset (with respect to central shaft CA) distance B 2 each other.In general particular valve incompetence and other factors that, distance B 2 can suffer from according to Bicuspid valve anatomical structure, patient change.Especially, distance B 2 can be changed to and promote contacting between structure under the first junction surface 72 and the second junction surface 74 and one or more lobe.For example, distance B 2 can change to make the first junction surface 72 to contact the part of lower free margins 34 of anterior mitral leaflet 24 and/or the chordae tendineae 32 relevant to anterior mitral leaflet 24 ' (and/or one or more papillary muscles 38 '), and make the second junction surface 74 contact the part of lower free margins 36 of rear portion mitral leaflet 26 and/or the chordae tendineae 32(relevant to rear portion mitral leaflet 26 and/or one or more papillary muscles 38 ').As shown in Fig. 4 C-Fig. 4 E and as described in following more details, two horizontal planes of heart reconstruction can be at device 10 _bwhile implantation securely, produce.

Fig. 5 A-Fig. 5 B has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Fig. 5 A-Fig. 5 B _cidentical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 5 A-Fig. 5 B, the structure identical with structure in Figure 1A-Fig. 1 I used identical Reference numeral, and with structural similarity in Figure 1A-Fig. 1 I but the not identical subsidiary subscript " c " of structure.Be understandable that device 10 _ccan be formed by any above-described material, and device 10 _ccan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

Device can comprise the ring lower support element 76 of Y shape or fork shape, and this ring lower support element 76 comprises the lower front support of ring portion 78, and with this ring under back support portion 80 under the ring of front support portion 78 positioned opposite.The lower front support of ring portion 78 and the lower back support of ring portion 80 are connected to primary importance 52 places of the support member 40 of general toroidal integratedly by common cervical region 82.Primary importance 52 can be on the first mid portion 44 or the second mid portion 46, and in the position adjacent with mitral joint close position.

As shown in Figure 5A, each of the lower front support of ring portion 78 and the lower back support of ring portion 80 comprises the first junction surface 72 and the second junction surface 74 that arrange at intervals.The first junction surface 72 and the second junction surface 74 can be spaced apart, and are axially offset (with respect to central shaft CA) distance B 1 each other.Alternately, each of the lower front support of ring portion 78 and the lower back support of ring portion 80 can have structure (Fig. 5 B) elongated, annular.The lower front support of ring portion 78 and radially D2 spaced apart of the lower back support of ring portion 80.Be understandable that, can change D1 and/or D2 and engage to optimize lobe leaf.

Fig. 6 A-Fig. 6 C has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Fig. 6 A-Fig. 6 C _didentical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 6 A-Fig. 6 C, the structure identical with structure in Figure 1A-Fig. 1 I used identical Reference numeral, and with structural similarity in Figure 1A-Fig. 1 I but the not identical subsidiary subscript " d " of structure.Be understandable that device 10 _dcan be formed by any above-described material, and device 10 _dcan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

As shown in Fig. 6 A-Fig. 6 C, device 10 _dthe support member 40 and the lower rear portion of ring and the front support member 180 that comprise general toroidal, under this ring, rear portion and front support member 180 are firmly connected with the support member 40 of general toroidal.The support member 40 of general toroidal can be complete ring, and comprises: the first pars intermedia 44; The second pars intermedia 46; Rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46; And leading section 50, this leading section 50 extends between the first pars intermedia 44 and the second pars intermedia 46, and with, rearward end 48 is oppositely arranged.Alternately, the support member 40 of general toroidal can be part annular, and comprises: the first pars intermedia 44; The second pars intermedia 46; And rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46.

Leading section 50 and rearward end 48 are set to be connected to respectively front portion 20 and the rear portion 22 of annulus of mitral valve 18.For example, rearward end 48, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, thereby make rearward end 48 have concave shape with respect to leading section 50.Similarly, leading section 50, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, thereby make leading section 50 have convex shape with respect to rearward end 48.Similar to the device 10 shown in Fig. 1 D, device 10 _dthe support member 40 of general toroidal also comprise longitudinal axes L A.The support member 40 of general toroidal can have structure rigidity or semirigid.

When device 10 _dbe implanted on annulus of mitral valve 18 or while being implanted to around annulus of mitral valve 18, size, shape and the structure of the lower rear portion of ring and front support member 180 is set to be positioned at rear portion mitral leaflet 26 and anterior mitral leaflet 24 belows and extends, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.The lower rear portion of ring and front support member 180 are directly connected to the support member 40 of general toroidal securely in primary importance 52.For example, as shown in Figure 6A, the lower rear portion of ring and front support member 180 are directly connected to the second pars intermedia 46 securely.Although do not show, be understandable that, alternately, the lower rear portion of ring and front support member 180 can directly be connected to the first pars intermedia 44 securely.

The lower rear portion of ring and front support member 180 comprise hook-type junction surface 182, and this hook-type junction surface 182 is directly connected to the support member 40 of general toroidal integratedly by cervical region 62.Junction surface 182 also comprises the first junction surface 184, the second junction surface 186 and the bending section 188 extending between the first junction surface 184 and the second junction surface 186.Each of the first junction surface 184 and the second junction surface 186 has continuous arc (or arc) structure, to be configured to through structure under at least one lobe or to be positioned at the rear of structure under at least one lobe and to extend.The first junction surface 184 and the second junction surface 186 can (difference) have concave shape or convex shape with respect to the leading section 50 of the support member 40 of general toroidal.

The first junction surface 184 is configured to through structure under at least one lobe or is positioned at the rear of structure under at least one lobe and extends, such as: the bottom outward appearance of rear portion lobe leaf 26, as the lower free margins 36 of rear portion lobe leaf 26; The chordae tendineae 32 relevant to rear portion lobe leaf 26; The one or more papillary muscless 38 relevant to the chordae tendineae 32 of rear portion lobe leaf 26; And the combination of the above part.In addition, the second junction surface 186 is configured to extend through structure under at least one lobe or is positioned at the rear of structure under at least one lobe and extends, such as: the bottom outward appearance of anterior lobe leaf 24, as the lower free margins 34 of anterior lobe leaf 24; The chordae tendineae 32 relevant to anterior lobe leaf 24 '; To one or more papillary muscless 38 of the chordae tendineae 32 of anterior lobe leaf 24 ' relevant '; And the combination of the above part.

The first junction surface 184 and the second junction surface 186 can be positioned at identical transverse plane (lateral plane) (, below longitudinal axes L A and parallel with longitudinal axes L A or substantially in parallel extend plane) in, or, alternately, the first junction surface 184 and the second junction surface 186 are offset each other with respect to central shaft CA.So, the first junction surface 184 can be positioned to contact structure under identical or different corresponding lobe with the second junction surface 186.For example, the first junction surface 184 and the second junction surface 186 are offset each other, the first junction surface 184 be configured to through the bottom outward appearance of rear portion lobe leaf 26 (such as, the lower free margins 36 of rear portion lobe leaf 26) or be positioned at rear portion lobe leaf 26 bottom outward appearance rear and extend, and the second junction surface 186 be configured to through the chordae tendineae 32 relevant to anterior lobe leaf 24 ' or be positioned at the chordae tendineae 32 relevant with anterior lobe leaf 24 ' rear and extend.

Fig. 6 B-Fig. 6 C has illustrated the alternative structure of the lower rear portion of ring and front support member 180.As shown in Figure 6B, the junction surface 182 of the lower rear portion of ring and front support member 180 can have bifurcation structure, comprises the first fastener 190 and the second fastener 192 that arrange at intervals.The first fastener 190 and the second fastener 192 can be spaced apart, and are axially offset (with respect to central shaft CA) distance B 1 each other.In general particular valve incompetence and other factors that, distance B 1 can suffer from according to Bicuspid valve anatomical structure, patient change.Especially, distance B 1 can be changed to and promote contacting between structure under the first fastener 190 and the second fastener 192 and one or more lobe.As mentioned above, each of the first fastener 190 and the second fastener 192 comprises the first junction surface 184 and the second junction surface 186.

As shown in Figure 6 C, the junction surface 182 of the lower rear portion of ring and front support member 180 can alternatively have arc, loop configuration, and this loop configuration comprises the hole 134 through this extensibility of structure.The junction surface 182 of annular can comprise the first fastener 190 and the second fastener 192 that are connected with common arc-shaped bend 194.The first fastener 190 and the second fastener 192 can be spaced apart, and are axially offset (with respect to central shaft CA) distance B 1 each other.In general particular valve incompetence and other factors that, distance B 1 can suffer from according to Bicuspid valve anatomical structure, patient change.

Be understandable that, with shown in Figure 1A-Figure 1B and above-described device 10 the same, device 10 _dcan comprise extraly or optionally other features.For example, device 10 _dcan comprise: governor motion 54; The cover layer 68 of biocompatible materials; Be convenient to device to be connected at least one labelling 70 of annulus of mitral valve 18; And/or the combination of a kind of healing potion or multiple healing potion.

Fig. 7 A-Fig. 7 C has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Fig. 7 A-Fig. 7 C _eidentical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 7 A-Fig. 7 C, the structure identical with structure in Figure 1A-Fig. 1 I used identical Reference numeral, and with structural similarity in Figure 1A-Fig. 1 I but the not identical subsidiary subscript " e " of structure.Be understandable that device 10 _ecan be formed by any above-described material, and device 10 _ecan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

As shown in Fig. 7 A-Fig. 7 C, device 10 _ecomprise back support member 42 under the support member 40, first ring of general toroidal ' and the lower back support member 42 of the second ring ".The support member 40 of general toroidal can be complete ring, and comprises: the first pars intermedia 44; The second pars intermedia 46; Rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46; Leading section 50, this leading section 50 extends between the first pars intermedia 44 and the second pars intermedia 46, and with rearward end 48 positioned opposite.Alternatively, class annular support member 40 can be part annular, and comprises: the first pars intermedia 44; The second pars intermedia 46; And rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46.

Leading section 50 and rearward end 48 are set to be connected to respectively front portion 20 and the rear portion 22 of annulus of mitral valve 18.For example, rearward end 48, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, thereby make rearward end 48 have concave shape with respect to leading section 50.Similarly, leading section 50, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, thereby make leading section 50 have convex shape with respect to rearward end 48.As shown in Fig. 7 C, the support member 40 of general toroidal also comprises longitudinal axes L A.The support member 40 of general toroidal can have rigidity or semirigid structure.

When device 10 _ebe implanted on annulus of mitral valve 18 or while being implanted to around annulus of mitral valve 18, back support member 42 under first ring ' and the lower back support member 42 of the second ring " size, shape and structure be set to be positioned at rear portion mitral leaflet 26 belows and extend, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.Back support member 42 under first ring ' be directly connected to securely the support member 40 of general toroidal in primary importance 52, and the lower back support member 42 of the second ring " is directly connected to the support member 40 of general toroidal securely in the second position 84 that is different from primary importance 52.For example, as shown in Figure 7 A, back support member 42 under first ring ' be directly connected to securely the first pars intermedia 44, and the lower back support member 42 of the second ring " is directly connected to the second pars intermedia 46 securely.

Back support member 42 under first ring ' and lower back support member 42 " extended distance D3 and the distance B 4 below the longitudinal axes L A of the support member 40 of general toroidal with angle A 1 and angle A 2 respectively of the second ring.Back support member 42 under first ring ' angle A 1 and the lower back support member 42 of the second ring " angle A 2 make back support member 42 under first ring ' and the lower back support member 42 of the second ring " can promote to optimize lobe leaf and engage.In one embodiment of the invention, back support member 42 under first ring ' angle A 1 and the lower back support member 42 of the second ring " angle A 2 in one or both can be between about 10 ° to about 60 ° (such as 30 °).Be understandable that, angle A 1 and angle A 2 can be identical or different.Similarly, distance B 3 and distance B 4 can make back support member 42 under first ring ' back support member 42 under encircling with second, and " part is separately extended below rear portion mitral valve lobe leaf 26, and to make, back support member 42 under first ring ' under encircling with second, back support member 42 " can promote to optimize lobe leaf joint.Be understandable that, distance B 3 and distance B 4 can be identical or different.

Back support member 42 under first ring ' with the lower back support member 42 of the second ring " each be configured to respectively similar or identical with back support member 42 shown in Figure 1A-Figure 1B and under above-described ring.For example, back support member 42 under first ring ' and the lower back support member 42 of the second ring " each comprise junction surface 60(Fig. 7 A) and the cervical region 62 that is integrally formed, this cervical region 62 extends to primary importance 52 from junction surface 60.Back support member 42 under first ring ' and the lower back support member 42 of the second ring " each junction surface 60 can there is bowed shape, to make each junction surface 60 there is concave shape with respect to the leading section 50 of the support member 40 of general toroidal.

Be understandable that, with shown in Figure 1A-Figure 1B and above-described device 10 the same, device 10 _ecan comprise extraly or optionally other features.For example, device 10 _ecan comprise: governor motion 54; The cover layer 68 of biocompatible materials; Be convenient to device to be connected at least one labelling 70 of annulus of mitral valve 18; And/or the combination of a kind of healing potion or multiple healing potion.

Fig. 8 A-Fig. 9 C has illustrated another aspect of the present invention, comprises the method for the blood reflux that is used for the treatment of the mitral valve by backflowing 12.Although will use the illustrated device 10 of Fig. 7 A-Fig. 7 B _edescribe Therapeutic Method of the present invention, but be understandable that, any device described herein also can be used for the treatment of the blood reflux by ill mitral valve.For example, the device 10f shown in Figure 13 A-Figure 13 B can be used for the treatment of dysfunction (such as, move limited) anterior mitral leaflet 24.

As mentioned above, device 10 _e(Fig. 7 A-Fig. 7 B) comprises D shape ring support member 40, and D shape ring support member 40 has saddle type shape, and in order to be connected to the three dimensional structure size of annulus of mitral valve 18.Device 10 _ealso comprise back support member 42 under the first ring of positioned opposite ' and the lower back support member 42 of the second ring ", shape back support member 42 under first ring ' and the lower back support member 42 of the second ring " form with the first pars intermedia 44 and second pars intermedia 46 of the support member 40 of general toroidal respectively.Although Fig. 7 A-Fig. 7 B does not show, be understandable that, can use the cover layer 68(of biocompatible materials such as suture ring) cladding system 10 _ea whole or part (such as, the support member 40 of general toroidal) only.

In order to treat the Bicuspid valve 12 backflowing, first should obtain mitral size with determining device 10 _eoptimum size.Can use valve measuring appliance to realize the dimensional measurement of Bicuspid valve 12.The example of valve dimensional measurement utensil is well known in the art, can comprise the measuring device that can buy on market, such as the measuring device (ATS medical company, Minneapolis city, the Minnesota State) of bileaflet heart valve standard measurer (ATS OPEN PIVOT STAND SIZER) series.In one embodiment of the invention, the size of Bicuspid valve 12 can be by being used the U.S. Patent application No.2009/0132036(of Na Weiya (Navia) hereinafter referred to as " 036 application ") disclosed valve measuring appliance 86 measures, and its full content is by reference to being incorporated into this.

As shown in Fig. 8 A-Fig. 8 C, measuring appliance 86 comprises handle member 88, and handle member 88 is connected to measuring piece 90 securely.Handle member 88 comprises that flexibly (fluidly) is connected to the handle 92 of far-end connecting portion 94.Handle 92 is for guiding measuring utensil 86, and far-end connecting portion 94 is for being connected to measuring piece 90 by handle 92.With reference to Fig. 8 B-Fig. 8 C, measuring piece 90 comprises annular support member 96, this annular support member 96 has leading section 98, rearward end 100, the first pars intermedia 102 and the second pars intermedia 104, the first pars intermedias 102 and the second pars intermedia 104 is oppositely arranged and extension between leading section 98 and rearward end 100.Annular support member 96 has planar structure (Fig. 8 B), also can have three-dimensional or saddle structure.

Measuring piece 90 defines longitudinal axis 106(Fig. 8 B), and comprise leg portion 108, this leg portion 108 has bindiny mechanism 110, such as the hole for coordinating with the far-end connecting portion 90 of handle member 88.As shown in Figure 8 B, leg portion 108 is extended above the longitudinal axis 106 of annular support member 96.Measuring piece 90 also comprise ring lower support element 112 and lobe lower device (such as, chordae tendineae 32 and chordae tendineae 32 ' and/or one or more papillary muscles 38 and papillary muscles 38 '), ring lower support element 112 is for supporting heart valve leaflet (such as, the bottom outward appearance of rear portion lobe leaf 26, following free margins 36).As shown in Figure 8 B, ring lower support element 112 extends below the longitudinal axis 106 of annular support member 96.In one embodiment of the invention, ring lower support element 112 can be set to below rear portion lobe leaf 26 to extend, and with at least one lobe under structural engagement.

In order to determine the size of Bicuspid valve 12 with measuring appliance 86, by beginning to speak, operation process obtains the path that arrives mitral valve.In this process, mitral valve 12 is directly perceived visual, therefore can by measuring appliance 86 particularly measuring piece 90 be positioned to the top outward appearance around Bicuspid valve 12.Use handle 92 to enter left atrium 14 with guiding measuring part 90, measuring appliance 86 is positioned to around Bicuspid valve 12, makes annular support member 96 contact annulus of mitral valve 18 and encircles lower support element 112 from rear contact or engage at least one lobe undertissue.

Next step, to monitoring to estimate the joint between anterior mitral leaflet 24 and rear portion mitral leaflet 26 by the blood volume of Bicuspid valve 12.The measuring piece of different size 90 is placed on Bicuspid valve 12 until observe normal Bicuspid valve joint roughly." normal blood flow " refer on physiology under normal pressure with normal speed on physiology unblocked through the valve of mammals biology or the blood motion of vascular system.In the time observing normal blood flow roughly through Bicuspid valve 12, record the size of measuring piece 90 and selection and have the device 10 of the size matching with the size of measuring piece 90 _ein order to implement implantation.Be understandable that, can engage and blood flow with the suitable lobe leaf that saline solution is tested to estimate by Bicuspid valve 12 extraly or alternately.

Selecting the suitable device 10 of size _eafterwards, will install 10 _ebe connected to and transmit utensil 114 or such as on disclosed supporter in " 036 application " (Fig. 8 D-Fig. 8 E).As shown in Fig. 8 D-Fig. 8 E, transmit utensil 114 or supporter and comprise annular support member 116, this annular support member 116 has leading section 118, rearward end 120, the first pars intermedia 122 and the second pars intermedia 124, the first pars intermedias 122 and the second pars intermedia 124 is oppositely arranged and extension between leading section 118 and rearward end 120.Transmit utensil 114 or supporter and comprise bindiny mechanism 126, such as the hole of the far-end connecting portion 94 for being connected to measuring appliance 86 (or structure) similarly.Annular support member 116 has the cross section of C shape, and the cross section of this C shape defines passage 128(Fig. 8 E).Passage 128 is around the circumferential extension of annular support member 116, and comprises that multiple extensions 130 are to promote installing 10 _ebe connected to and transmit utensil 114 or supporter.Transmit utensil 114 or supporter and can comprise multiple stitching thread junction points 132, can implement seam zygonema will install 10 through stitching thread junction point 132 _ebe connected to and transmit utensil 114 or supporter.Can carry out apparatus for removing 10 by the stitching thread excising on different stitching thread junction points 132 _e.

For starting apparatus 10 _eimplant procedure, can be by silica gel tube (not shown) through at least one joint close position of Bicuspid valve 12 and be positioned at the rear of structure under at least one lobe, such as the chordae tendineae relevant to rear portion mitral leaflet 26 32 and chordae tendineae 32 ' and/or one or more papillary muscles 38 and papillary muscles 38 '.When device 10 _ebe connected to securely while transmitting utensil 114, stitching thread (not shown) is arranged in annulus of mitral valve 18.Transmit utensil 114 and be positioned to the top outward appearance around Bicuspid valve 12.Then, stitching thread through one or more labelling 70(such as, hole), transmit utensil 114 simultaneously and engage Bicuspid valve 12 and device 10 _ethe support member 40 of general toroidal be pushed to annulus of mitral valve 18.Then, operation silica gel tube so that the open end of silica gel tube engage back support member 42 under first ring ' and the lower back support member 42 of the second ring " at least one far-end.Then by silica gel tube never abutting end extract out lightly, this will cause back support member 42 under first ring ' and the lower back support member 42 of the second ring " through moving and engage from rear with structure under at least one lobe in joint close position.Then throw off silica gel tube, then remove handle member 88 and tension stitching thread, to make device 10 _ebe positioned to securely around Bicuspid valve 12.When completing after sutural tension, cut off stitching thread will transmit utensil 114 or supporter from installing 10 _eupper separation also removes from left atrium 14.

Along with device, 10e locates (Fig. 9 A-Fig. 9 C) securely, can produce the horizontal plane of two heart reconstructions simultaneously.At ring lower horizontal plane, by moving forward structure under lobe (one or more), back support member 42 under first ring ' and the lower back support member 42 of the second ring " support structure under at least one lobe (such as; the lower free margins 36 of rear portion mitral leaflet 26, the chordae tendineae 32 relevant to rear portion lobe leaf 26 and chordae tendineae 32 ' and/or one or more papillary muscless 38 relevant with rear portion lobe leaf 26 and papillary muscles 38 '), this action by minimizing rear portion mitral leaflet is limited and prevent or alleviate by the blood reflux of Bicuspid valve 12.In addition, promote (or mobile) rear portion left ventricular wall by (or placed in the middle) forward and can prevent or alleviate the Left Ventricular Remodeling (, oppositely reinventing mechanism) being caused by ischemic expansion cardiomyopathy.In addition, on annular horizontal plane, a part that promotes forward rear portion left ventricular wall not only can prevent or alleviate the Ventricular Remodeling that ischemic expansion cardiomyopathy causes, and can reduce in time the relapse rate that the mitral valve passed backflows.Or on annular horizontal plane, device 10 _ethree-dimensional saddle type geometry also reinvented annulus of mitral valve 18 and reduced annular diameter, thereby can improve lobe leaf engage.Based on device 10 _esuitable implantation, complete this program and can recover by the normal blood flow of Bicuspid valve 12.

Figure 10 A-Figure 12 C has illustrated other geometry deformations of the device 10 shown in Figure 1A-Fig. 1 D.For example, as shown in Figure 10 A, back support member 42 under first ring ' and the lower back support member 42 of the second ring " each junction surface 60 can alternatively there is fork configuration.Especially, each junction surface 60 can comprise that the first junction surface 72 of positioned opposite and 74, the first junction surfaces 72, the second junction surface and the second junction surface 74 arrange at intervals, and skew (with respect to central shaft CA) distance B 1 axially.According to the anatomical structure of patient's Bicuspid valve 12, particular valve incompetence and other factors that patient suffers from, back support member 42 under first ring ' and the second ring under back support member 42 " between distance B 1 can be identical or different.Each of the first junction surface 72 and the second junction surface 74 can have concave shape with respect to the leading section of the support member of general toroidal 40 50.In addition, each of the first junction surface 72 and the second junction surface 74 can be through the whole of structure under at least one lobe or a part or be positioned at the rears whole or an only part of structure under at least one lobe and extend (Figure 10 B) only.

As shown in Figure 11 A-Figure 11 B, back support member 42 under first ring ' and the lower back support member 42 of the second ring " each can alternately there is curved annular structure, this structure comprises the hole 134 of extending through this structure.Back support member 42 under first ring ' and the lower back support member 42 of the second ring " each junction surface 60 can there is concave shape with respect to the leading section of the support member of general toroidal 40 50.Alternately, back support member 42 under first ring ' and the lower back support member 42 of the second ring " each junction surface 60 through the whole of structure under at least one lobe or a part or be positioned at the rears whole or an only part of structure under at least one lobe and extend (Figure 11 B) only.

As shown in Figure 12 A-Figure 12 C, back support member 42 under first ring ' and the lower back support member 42 of the second ring " each can be configured to the illustrated first ring of Fig. 7 A-Fig. 7 B under back support member 42 ' and the lower back support member 42 of the second ring " similar.But, as shown in Figure 12 B, back support member 42 under first ring ' be set to extend the first distance B ', this first distance B ' be less than and back support member 42 under the second ring " corresponding second distance D ".That is to say the first distance B ' be less than second distance D " to make back support member 42 under first ring ' back support member 42 under encircling with second " with respect to central shaft CA axially skew (Figure 12 A) each other.

In addition, in Figure 12 A, can see, back support member 42 under first ring ' length L 1 be set to the second ring under back support member 42 " corresponding length L2 overlaid.Back support member 42 under first ring ' and the lower back support member 42 of the second ring " each junction surface 60 can there is concave shape with respect to the leading section of the support member of general toroidal 40 50.In addition, back support member 42 under first ring ' and the lower back support member 42 of the second ring " each junction surface 60 through the whole of structure under at least one lobe or a part or be positioned at the rears whole or an only part of structure under at least one lobe and extend (Figure 12 C) only.

Figure 13 A-Figure 13 B has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Figure 13 A-Figure 13 B _fwith the device 10 shown in Fig. 7 A-Fig. 7 B _estructure identical.In Figure 13 A-Figure 13 B, the structure identical with structure in Fig. 7 A-Fig. 7 B used identical Reference numeral, and with structural similarity in Fig. 7 A-Fig. 7 B but the not identical subsidiary subscript " f " of structure.Be understandable that device 10 _fcan be formed by any above-described material, and device 10 _fcan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

As shown in Figure 13 A-Figure 13 B, device 10 _fcomprise front support member 136 and the lower front support member 138 of the second ring under the support member 40, first ring of general toroidal.The support member 40 of general toroidal can be complete annular, and comprises: the first pars intermedia 44; The second pars intermedia 46; Rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46; And leading section 50, this leading section 50 extends between the first pars intermedia 44 and the second pars intermedia 46, and with rearward end 48 positioned opposite.Alternately, class annular support member 40 can be part annular, and comprises: the first pars intermedia 44; The second pars intermedia 46; And rearward end 48, this rearward end 48 is extended between the first pars intermedia 44 and the second pars intermedia 46.

Leading section 50(Figure 13 A-Figure 13 B) and rearward end 48 be set to be connected to respectively front portion 20 and the rear portion 22 of annulus of mitral valve 18.For example, rearward end 48, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, thereby make rearward end 48 have concave shape with respect to leading section 50.Similarly, leading section 50, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, thereby make leading section 50 have convex shape with respect to rearward end 48.As shown in Figure 13 B, the support member 40 of general toroidal also comprises longitudinal axes L A.The support member 40 of general toroidal can have rigidity or semirigid structure.

When device 10 _fbe implanted on annulus of mitral valve 18 or while being implanted to around annulus of mitral valve 18, under first ring, size, shape and the structure of front support member 136 and the lower front support member 138 of the second ring are set to be positioned at anterior mitral leaflet 24 belows and extend, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.Under first ring, front support member 136 is directly connected to the support member 40 of general toroidal securely in primary importance 52, and the lower front support member 138 of the second ring is directly connected to the support member 40 of general toroidal securely in the second position 84 that is different from primary importance 52.For example, as shown in FIG. 13A, under first ring, front support member 136 is directly connected to the first pars intermedia 44 securely, and the lower front support member 138 of the second ring is directly connected to the second pars intermedia 46 securely.

As shown in Figure 13 B, lower front support member 138 extended distance D3 and the distance B 4 below the longitudinal axes L A of the support member 40 of general toroidal with angle A 1 and angle A 2 respectively of front support member 136 and the second ring under first ring.Under first ring, the angle A 2 of the angle A 1 of front support member 136 and the lower front support member 138 of the second ring makes respectively under first ring front support member 136 and the lower front support member 138 of the second ring can promote to optimize lobe leaf to engage.In one embodiment of the invention, under first ring, the one or both in the angle A 2 of the angle A 1 of front support member 136 and the lower front support member 138 of the second ring can be respectively between about 20 ° to about 60 ° (such as 30 °).Be understandable that, angle A 1 and angle A 2 can be identical or different.Similarly, distance B 3 and distance B 4 can make front support member 136 under first ring and the lower front support member 138 of a second ring part separately below anterior mitral leaflet 24, extend respectively, engage to make under first ring front support member 136 and the lower front support member 138 of the second ring can promote to optimize lobe leaf.Be understandable that, distance B 3 and distance B 4 can be identical or different.

Under first ring, each of front support member 136 and the lower front support member 138 of the second ring is configured to respectively the structural similarity of back support member 42 shown in Figure 1A-Figure 1B and under above-described ring or identical.For example, under first ring, front support member 136 and the lower front support member 138 of the second ring each (Figure 13 A) comprises respectively junction surface 140 and the cervical region 142 being integrally formed, and this cervical region 142 extends to primary importance 52 from junction surface 140.Under first ring, each junction surface 140 of front support member 136 and the lower front support member 138 of the second ring can have bowed shape (such as, convex) with respect to the leading section of the support member of general toroidal 40 50.

Be understandable that, with the device 10 shown in Fig. 7 A-Fig. 7 B _eand the above is the same, device 10 _fcan comprise extraly or optionally other features.For example, device 10 _fcan comprise: governor motion 54; The cover layer 68 of biocompatible materials; Be convenient to device to be connected at least one labelling 70 of annulus of mitral valve 18; And/or the combination of a kind of healing potion or multiple healing potion.

Figure 14 A-Figure 14 C has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Figure 14 A-Figure 14 C _grespectively with the device 10 shown in Figure 1A-Fig. 1 E and Figure 13 A-Figure 13 B shown device 10 _fstructure identical.In Figure 14 A-Figure 14 C, the structure identical with structure in Figure 1A-Fig. 1 E and Figure 13 A-Figure 13 B used identical Reference numeral, and with structural similarity in Figure 1A-Fig. 1 E and Figure 13 A-Figure 13 B but the not identical subsidiary subscript " g " of structure.Be understandable that device 10 _gcan be formed by any above-described material, and device 10 _gcan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

As shown in figure 15, Tricuspid valve 144 is between right atrium 146 and right ventricle 148.Tricuspid valve 144 is by tricuspid valve leaflets (describing below), tricuspid annulus 150, support chordae tendineae (generally by 152 instructions) and papillary muscles (generally by 154 instructions).Tricuspid valve 144 itself favours vertical direction a little, therefore the edge of valve in front upper position, the next and in every position, and by these link positions, lobe leaf is named.Front upper lobe leaf 156 is maximum lobe leaves, and is inserted between atrioventricular orifice (not shown) and arterial cone (not shown).Rear lobe leaf 158 is second largest lobe leaves, and according to the relative rearward position at its place and concern in the edge of right ventricle 148 and name.The 3rd is connected to right fibrous trigone and left fibrous trigone (not shown) and chamber barrier film every position lobe leaf 160 in little also minimum.Under tricuspid valve lobe, organ comprises anterior papillary muscles, rear portion papillary muscles and middle septal papillary muscles 154 and their true chordae tendineae (their true chordae tendineae) 152.False chordae tendineae (False chordae) (not shown) can connect two papillary muscless 154, connects papillary muscles with ventricle wall or be connected the point (points) in ventricle wall.True chordae tendineae 152 typically originates in top the 3rd papillary muscles 154, but also can originate in ventricle wall the same as middle septal cusp 160.

With reference to Figure 14 A-Figure 14 C, device 10 _gcan comprise the support member 40 of general toroidal _gand the lower front support member 162 of at least one ring, the support member 40 of the lower front support member 162 of ring and general toroidal _gfirmly connect.The support member 40 of general toroidal _gcan there is Figure 15 with tricuspid annulus 150() 3D shape corresponding to 3D shape.The support member 40 of general toroidal _gcan limit longitudinal axes L A(Figure 14 C), and the support member 40 of general toroidal _gcomprise leading section 50 _g, rearward end 48 _g, and positioned opposite at leading section 50 _gwith rearward end 48 _gbetween extend the first pars intermedia 44 _gwith the second pars intermedia 46 _g.Leading section 50 _gwith rearward end 48 _gbe set to be connected to respectively the front and rear (Figure 15) of tricuspid annulus 150.Although the support member 40 of general toroidal _g(Figure 14 A-Figure 14 C) is shown as has C shape or part loop configuration, but is understandable that the support member 40 of general toroidal _gcan there are other structures, such as complete loop configuration.

As shown in Figure 14 A-Figure 14 C, device 10 _gcomprise the lower front support member 162 of ring.But be understandable that device 10 _gcan comprise front support member 162(Figure 14 D-Figure 14 E under more than one ring) and/or one or more for supporting ring lower support element (Figure 17 A-Figure 17 E) and/or the rear tricuspid valve leaflets 158 every position lobe leaf 160.The lower front support member 162 of ring is set to be positioned at the below of front upper lobe leaf 156 and extends, and through the whole of structure under at least one lobe or a part or be positioned at the belows whole or an only part of structure under at least one lobe and extend only.Under ring as shown in Figure 14 A-Figure 14 C, front support member 162 can be set to through following structure or be positioned at the rear of following structure and extend: the lower free margins of an only part for whole lower free margins (not shown) of front upper tricuspid valve leaflets 156, front upper tricuspid valve leaflets 156, the chordae tendineae 152 relevant to front upper tricuspid valve leaflets 156 whole or only a part and/or the papillary muscles 154 relevant with front upper tricuspid valve leaflets 156 whole or only a part of.

Be understandable that, shape, structure and the size of the lower front support member 162 of ring can be set to through structure under other lobes or be positioned at the below of structure under other lobes and extend, such as: in every whole lower free margins (showing demonstration) of position tricuspid valve leaflets 160; In every position tricuspid valve leaflets 160 only a part lower free margins; To in every the whole of the relevant chordae tendineae 152 of position tricuspid valve leaflets 160 or only a part; To in every the whole of the relevant papillary muscles 154 of position tricuspid valve leaflets 160 or only a part; Whole lower free margins (not shown) of rear tricuspid valve leaflets 158; The only lower free margins of a part of rear tricuspid valve leaflets 158; The chordae tendineae 152 relevant to rear tricuspid valve leaflets 158 whole or only a part and/or the papillary muscles 154 relevant with rear tricuspid valve leaflets 158 whole or only a part.

The lower front support member 162 of ring can have rigidity or semirigid structure.For example, when the lower front support member 162 of ring has semirigid structure, under first ring, front support member can be bending or be adjusted to different positions.It is described above that the lower front support member 162 of ring can extraly or preferably include governor motion 54(), the support member 40 in order to front support member 162 under adjustable ring optionally with respect to general toroidal _gthe position of longitudinal axes L A.

As shown in Figure 14 C, the lower front support member 162 of ring with angle A 3 support member 40 in general toroidal _flongitudinal axes L A below extended distance D5.The angle A 3 of the lower front support member 162 of ring can make to encircle lower front support member 162 and promote to optimize lobe leaf joint.In one embodiment of the invention, the angle A 3 of the lower front support member 162 of ring can be about 20 ° to about 40 ° (such as about 30 °).Similarly, distance B 5 can make a part of encircling lower front support member 162 extend below front upper tricuspid valve leaflets 156, to promote that optimizing lobe leaf engages.

The lower front support member 162 of ring has structure long and narrow, that be roughly U-shaped, and comprises cervical region 164(Figure 14 A), this cervical region 164 forms with junction surface 166.Cervical region 164 is set between this joint close position, extending between the joint close position of the corresponding one of tricuspid valve leaflets 156, tricuspid valve leaflets 158 and tricuspid valve leaflets 160 or approx.As shown in Figure 14 A-Figure 14 B, cervical region 164 comprises first end 168 and second end 170 of positioned opposite, this first end 168 and the second end 170 respectively with the support member 40 of general toroidal _gform with junction surface 166.For example, the first end 168 of cervical region 164 can with the support member of general toroidal 40 _fthe first pars intermedia 44 _gform.

The junction surface 166 of the lower front support member 162 of ring is with respect to the support member 40 of general toroidal _grearward end 48 _gthere is concave shape.Based on implantation, junction surface 166 whole or only a part are set to contact structure under lobe whole or an only part.Be understandable that, the lower front support member 162 of ring can have one or more combination of structure shown in Fig. 4 A-Fig. 4 B, Fig. 5-Fig. 6, Figure 14 D-Figure 14 E and Figure 17 D-Figure 17 E; Certainly the junction surface 166, providing is with respect to the support member 40 of general toroidal _gleading section 50 _gor rearward end 48 _gthere is concave shape.

Another aspect of the present invention that Figure 16 A-Figure 16 B illustrates, comprises a kind of being used for the treatment of by the method for the blood reflux of the tricuspid valve 144 that backflows.To this Therapeutic Method be described with the device 10g shown in Figure 14 A-Figure 14 C although following, but should be understood that, also can use the device of any one or the multiple combination that comprise the geometry variation this place discussed to treat by the blood reflux of the tricuspid valve 144 that backflows.

As mentioned above, device 10 _g(Figure 14 A-Figure 14 C) comprises the support member 40 of part annular _g, this has the support member 40 of the part annular of three dimensional structure _gbe set to for being connected to tricuspid annulus 150.Device 10 _galso comprise the lower front support member 162 of ring, the support member 40 of front support member 162 and general toroidal under this ring _gthe first pars intermedia 44 _fform.Although do not show at Figure 14 A-Figure 14 C, be understandable that, can be with the cover layer 68(of biocompatible materials such as suture ring), the combination of at least one labelling 70 and/or a kind of healing potion or multiple healing potion carrys out cladding system 10 _fwhole or only a part (such as, annular support member 40 _f).

Described Therapeutic Method can be according to carrying out with the roughly the same mode of the above-described method that is used for the treatment of the mitral valve 12 backflowing.The size that for example, first should obtain Tricuspid valve 144 is with determining device 10 _goptimum size.Can use valve measuring appliance to realize the dimensional measurement of Tricuspid valve 144, such as above-described measuring appliance 86.After determining the size of tricuspid valve 144, can to monitor by the blood volume of tricuspid valve to estimate front upper lobe leaf 156, rear lobe leaf 158 and in described above every position lobe leaf 160() between joint.The measuring piece of different size 90 can be placed on Tricuspid valve 144 until observe normal liquid stream roughly by Tricuspid valve 144 (such as, blood or saline).In the time observing normal blood flow roughly by Tricuspid valve 144, the device 10g that records the size of measuring piece 90 and select to have the size matching with the size of measuring piece 90 implants in order to implementing.Should be understood that, can test to estimate by the liquid stream of Tricuspid valve 144 and suitable lobe leaf joint with saline solution extraly or alternately.

Selecting the suitable device 10 of size _gafterwards, will install 10 _gbe connected to and transmit on utensil 114 or above-described supporter.In order to start implant procedure, can be by silica gel tube (not shown) through at least one joint close position of Tricuspid valve 144 and be positioned at the rear of structure under at least one lobe, such as chordae tendineae 152 and/or the one or more papillary muscles 154 relevant to front upper tricuspid valve leaflets 156.When device 10 _gbe connected to securely while transmitting utensil 114, stitching thread (not shown) is arranged in tricuspid annulus 150.Then transmit utensil 114 and be positioned to the top outward appearance around Tricuspid valve 144.Then, stitching thread through one or more labelling 70(such as, hole), transmit utensil 114 simultaneously and engage Tricuspid valve 144 and device 10 _gthe support member 40 of general toroidal _gbe pushed to tricuspid annulus 150.

After finishing these, operation silica gel tube is so that the open end of silica gel tube engages the far-end of front support member 162 under first ring.Then by silica gel tube never abutting end extract out lightly, this will cause under first ring front support member 162 to move through joint close position and with at least one lobe under structural engagement.Then throw off silica gel tube, then remove handle member 88 and tension stitching thread, to make device 10 _gbe positioned to securely around Tricuspid valve 144.When completing after sutural tension, cut off stitching thread will transmit utensil 114 or supporter from installing 10 _gupper separation also removes from right atrium 14.

Along with device, 10g locates (Figure 16 A-Figure 16 B) securely, can produce the horizontal plane of two heart reconstructions simultaneously.On ring lower horizontal plane, by move forward structure under lobe (one or more) in heart contraction process, under first ring front support member 162 support structure under at least one lobe (such as, before lower free margins, the chordae tendineae 152 relevant to anterior lobe leaf and/or the one or more papillary muscless 154 relevant with anterior lobe leaf of upper tricuspid valve leaflets 156), this action by minimizing front tricuspid valve leaflets 24 is limited and prevent or alleviate by the blood reflux of Tricuspid valve 144.In addition, can prevent or alleviate by the antetheca or the rear wall that promote forward (or mobile) right ventricle 148 Ventricular Remodeling being caused by ischemic expansion cardiomyopathy.In addition, on annular horizontal plane, device 10 _gthree-dimensional saddle type geometry also reinvented tricuspid annulus 150 and reduced annular diameter, thereby can improve lobe leaf engage.Based on device 10 _gsuitable implantation, complete this program and can recover by the normal blood flow of Tricuspid valve 144.

Figure 18 A-Figure 18 C has illustrated another aspect of the present invention.Except the following stated, the device 10 shown in Figure 18 A-Figure 18 C _hwith the device 10 shown in Figure 14 A-Figure 14 C _gstructure identical.In Figure 18 A-Figure 18 C, the structure identical with structure in Figure 14 A-Figure 14 C used identical Reference numeral, and with structural similarity in Figure 14 A-Figure 14 C but the not identical subsidiary subscript " h " of structure.Be understandable that device 10 _hcan be formed by any above-described material, and device 10 _hcan comprise cover layer 68 and/or the healing potion (one or more) of above-described biocompatible materials.

Device 10 _hcomprise the support member 40 of general toroidal _gand with the support member 40 of this general toroidal _gthe lower triplen support member 200 of at least one ring connecting securely.Annular support member 40 roughly _gcan there is Figure 15 with tricuspid annulus 150() 3D shape corresponding to 3D shape.The support member 40 of general toroidal _gcan limit longitudinal axes L A(as shown in Figure 14 C), and the support member 40 of general toroidal _gcomprise leading section 50 _g, rearward end 48 _g, and positioned opposite at leading section 50 _gwith rearward end 48 _gbetween extend the first pars intermedia 44 _gwith the second pars intermedia 46 _g.Leading section 50 _gwith rearward end 48 _gbe set to be connected to respectively the front and rear (Figure 15) of tricuspid annulus 150.Although the support member 40 of general toroidal _gbe shown as the structure with C shape or part annular, but be understandable that the support member 40 of general toroidal _gcan there are other structures, such as complete loop configuration.

When device 10 _hbe implanted in tricuspid annulus 150 or while being implanted to around tricuspid annulus 150, size, shape and the structure of the lower triplen support member 200 of ring are set to be arranged in front upper lobe leaf 156, rear lobe leaf 158 and extend every lobe leaf 160 belows, position, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.The lower triplen support member 200 of ring is directly connected to the support member 40 of general toroidal securely in primary importance 202 _g.For example, as shown in Figure 6A, the lower triplen support member 200 of ring is directly connected to the first pars intermedia 44 securely _g.Although do not show, be understandable that, the lower triplen support member 200 of ring can alternately directly be connected to the second pars intermedia 46 securely _g.

The lower triplen support member 200 of ring comprises hook-type junction surface 182 _h, this hook-type junction surface 182 _hdirectly be connected to integratedly the support member 40 of general toroidal by cervical region 164 _g.Hook-type junction surface 182 _halso comprise the first junction surface 184 _h, the second junction surface 186 _hand at the first junction surface 184 _hwith the second junction surface 186 _hbetween extend bending section 188 _h.The first junction surface 184 _hwith the second junction surface 186 _heach there is continuous arc (or arc) structure, with through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.The first junction surface 184 _hwith the second junction surface 186 _hcan be with respect to the support member of general toroidal 40 _gleading section 50 _g(difference) has concave shape and convex shape.

The first junction surface 184 _hbe configured to through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend, such as: the bottom outward appearance of rear portion lobe leaf 158, such as the lower free margins (not shown) of rear portion lobe leaf 158; The chordae tendineae 152 relevant to rear portion lobe leaf 158; The one or more papillary muscless 154 relevant to the chordae tendineae of rear portion lobe leaf 158; And the combination of the above part.In addition the second junction surface 186, _hbe configured to through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend, such as: the bottom outward appearance of front upper lobe leaf 156, such as the lower free margins (not shown) of front upper lobe leaf; The chordae tendineae 152 relevant to front upper lobe leaf; The one or more papillary muscless 154 relevant to the chordae tendineae of front upper lobe leaf; In every the bottom outward appearance of position lobe leaf 160, such as in every the lower free margins (not shown) of position lobe leaf 160; To in every the relevant chordae tendineae of position lobe leaf 160; The one or more papillary muscless relevant to the chordae tendineae of front upper lobe leaf; And the combination of the above part.In one embodiment of the invention, the second junction surface 186 _hbe configured to through at least one to front upper lobe leaf 156 and under the lobe of position lobe leaf 160 relevant (or comprising) structure or be arranged at least one with front upper lobe leaf 156 and the lobe of being correlated with (or comprising) every position lobe leaf 160 under structure rear and extend.

The first junction surface 184 _hwith the second junction surface 186 _hcan be positioned at identical transverse plane (that is, and below longitudinal axes L A and parallel with longitudinal axes L A or substantially in parallel extend plane), or, alternately, the first junction surface 184 _hwith the second junction surface 186 _hdo not show in Figure 18 A-Figure 18 C with respect to central shaft CA() skew each other.So, the first junction surface 184 _hwith the second junction surface 186 _hcan be positioned to contact structure under identical or different corresponding lobe.For example, the first junction surface 184 _hwith the second junction surface 186 _hskew each other, the first junction surface 184 _hbe configured to bottom outward appearance through rear portion lobe leaf 158 (such as, the lower free margins of rear portion lobe leaf 158) or be positioned at rear portion lobe leaf 158 bottom outward appearance rear and extend and the second junction surface 186 _hbe configured to through to front upper lobe leaf 156 and in every the relevant chordae tendineae 152 of position lobe leaf 160 or be arranged in front upper lobe leaf 156 with every the rear of the relevant chordae tendineae 152 of position lobe leaf 160 and extend.

Be understandable that, the same with the device 10 shown in Figure 1A-Figure 1B and the above, device 10 _dcan comprise extraly or optionally other features.For example, device 10 _dcan comprise: governor motion 54; The cover layer 68 of biocompatible materials; Be convenient to device to be connected at least one labelling 70 of annulus of mitral valve 18; And/or the combination of a kind of healing potion or multiple healing potion.

By the above description of this invention, it will be appreciated by those skilled in the art that improvement of the present invention, distortion and amendment.The skill that these improve, distortion and amendment belong to this area and have the personnel of ordinary skill.

Claims (according to the amendment of the 19th article of treaty)

1. treatment is by a device for the blood reflux of diseased heart valve, and described diseased heart valve comprises organ under valve annulus, anterior valve lobe leaf, rear portion valve lobe leaf and lobe, and described device comprises:

The support member of general toroidal, the support member of this general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, described rearward end is extended between described the first pars intermedia and described the second pars intermedia, and described rearward end is set to the rear portion of the described valve annulus for being connected to described diseased heart valve; And

At least one encircles lower support element, this ring lower support element is connected to the support member of described general toroidal securely in primary importance, described at least one ring lower support element be set to be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and extend, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.

2. device according to claim 1, wherein, the support member of described general toroidal has the saddle structure matching with the three dimensional structure of described valve annulus.

3. device according to claim 1, wherein, the support member of described general toroidal also comprises leading section, described leading section extends and relatively arranges with described rearward end between described the first pars intermedia and described the second pars intermedia, and described leading section is set to be connected with the front portion of the described valve annulus of described diseased heart valve.

4. device according to claim 1, wherein, described at least one ring lower support element also comprises:

Arcuate engagement portion, this arcuate engagement portion is configured to contact from rear with structure under described at least one lobe; And

The cervical region being integrally formed, this cervical region extends to described primary importance from described junction surface.

5. device according to claim 4, wherein, described junction surface has convex shape with respect to the described rearward end of the support member of described general toroidal.

6. device according to claim 1, wherein, described at least one ring lower support element has bifurcation structure, and this bifurcation structure comprises the first junction surface and the second junction surface that arrange at intervals.

7. device according to claim 6, wherein, described the first junction surface and described the second junction surface be axially skew each other.

8. device according to claim 6, wherein, described the first junction surface and described the second junction surface be radially skew each other.

9. device according to claim 1, wherein, described at least one ring lower support element has long and narrow loop configuration.

10. device according to claim 1, wherein, this device also comprises the second ring lower support element, this second ring lower support element is connected to the support member of described general toroidal securely in described primary importance.

11. devices according to claim 1, wherein, described at least one ring lower support element comprises governor motion, this governor motion is for optionally regulating the position of described at least one ring lower support element with respect to the longitudinal axis of the support member of described general toroidal.

12. devices according to claim 1, wherein, under described at least one lobe, structure at least comprises: a part for a part for the lower free margins of described rear portion valve lobe leaf or described anterior valve lobe leaf, the chordae tendineae relevant to described rear portion valve lobe leaf or described anterior valve lobe leaf, or a part for the papillary muscles relevant to described rear portion valve lobe leaf or described anterior valve lobe leaf.

13. 1 kinds of treatments are by the device of the blood reflux of diseased heart valve, and described diseased heart valve comprises organ under valve annulus, anterior valve lobe leaf, rear portion valve lobe leaf and lobe, and described device comprises:

The support member of general toroidal, the support member of this general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, described rearward end is extended between described the first pars intermedia and described the second pars intermedia, and described rearward end is set to the rear portion of the described valve annulus for being connected to described diseased heart valve;

First ring lower support element, this first ring lower support element is connected to the support member of described general toroidal securely in primary importance; And

The second ring lower support element, this second ring lower support element is connected to the support member of described general toroidal securely in the second position;

Wherein, described first ring lower support element and described the second ring lower support element be set to be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and extend through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.

14. devices according to claim 13, wherein, described primary importance and the described second position arrange relative to one another.

15. devices according to claim 13, wherein, a part for described first ring lower support element and described second ring lower support element a part overlapping and axially skew.

16. devices according to claim 13, wherein, under described at least one lobe, structure at least comprises: a part for a part for the lower free margins of described rear portion valve lobe leaf or described anterior valve lobe leaf, the chordae tendineae relevant to described rear portion valve lobe leaf or described anterior valve lobe leaf, or a part for the papillary muscles relevant to described rear portion valve lobe leaf or described anterior valve lobe leaf.

Claims

Wherein, described first ring lower support element and described the second ring lower support element be set to be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and extend, and through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend.

17. 1 kinds of treatments are by the method for the blood reflux of diseased heart, and described diseased heart valve comprises organ under valve annulus, anterior valve lobe leaf, rear portion valve lobe leaf and lobe, and described method comprises the steps:

Step is provided, a kind of device is provided in this step, at least one ring lower support element that this device comprises the support member of general toroidal and is connected securely with the support member of described general toroidal, the support member of this general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, and described rearward end is extended between described the first pars intermedia and described the second pars intermedia; And

Connection Step, the support member of described general toroidal is connected to the described valve annulus of described diseased heart valve in this step, make described at least one ring lower support element be positioned at described rear portion valve lobe leaf and described anterior valve lobe leaf at least one below and extend through structure under at least one lobe or be positioned at the rear of structure under at least one lobe and extend, to prevent or roughly to reduce by the blood reflux of diseased heart valve.

Method described in 18. described in claim 17, wherein, the step that the support member of described general toroidal is connected to the described valve annulus of described diseased heart valve also comprises:

Step is provided, a kind of measuring appliance is provided in this step, this measuring appliance comprises measuring piece and is connected to the handle member of far-end connecting portion, described measuring piece comprises the annular element that limits longitudinal axis, this annular element has leading section and rearward end, and the first pars intermedia and the second pars intermedia that between described leading section and described rearward end, extend, the lobe leaf support member that described measuring piece also comprises support portion and is connected with described support portion, extend between described the first pars intermedia and described the second pars intermedia described support portion, described lobe leaf support member extends below described longitudinal axis,

Place step, in this step, described measuring piece is placed in the ventricle relevant to described diseased heart valve, to make described annular element contact the described valve annulus of described diseased heart valve; And

Measuring process, in this step to measuring by the liquid stream of described diseased heart valve, to determine the optimum size of described device;

Wherein, can indicate the described optimum size of described device by the normal liquid stream of described diseased heart valve.

19. methods according to claim 18, wherein, described method also comprises the steps:

Connection Step is connected to the device of described optimum size and transmits utensil or supporter in this step;

Positioning step is positioned to the described valve annulus around described diseased heart valve by described transmission utensil in this step; And

Set-up procedure is adjusted described device in this step.

20. methods according to claim 17, wherein, the support member of described general toroidal is connected to described diseased heart valve described valve annulus described Connection Step by oppositely reinvent mechanism side by side provide heart reconstruction annular horizontal plane and ring lower horizontal plane.

21. methods according to claim 20, wherein, describedly oppositely reinvent described horizontal plane and correctization of angle and normalization that mechanism side by side makes lobe leaf engage, prevent lobe leaf constraint and eliminate the recurrence of the valvular regurgitation of passing in time.

22. methods according to claim 20, wherein, the heart reconstruction at described annular horizontal plane place can be prevented or be alleviated Ventricular Remodeling by mobile rear portion ventricle wall, and, the heart reconstruction at described ring lower horizontal plane place can make at least one in described rear portion lobe leaf, described anterior lobe leaf, chordae tendineae or papillary muscles move, thereby it is limited to reduce the action of heart contraction process postmedian lobe leaf or anterior lobe leaf.