CN103987341B

CN103987341B - Apparatus and method for treating a regurgitant heart valve

Info

Publication number: CN103987341B
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: 2017-02-22
Anticipated expiration: 2032-01-04
Also published as: JP2014506175A; CN103987341A; JP5695213B2

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

Cross-Reference to Related Applications

This application claims on January 4th, 2011 submits to the, U.S. Provisional Patent Application of Serial No. No.61/429,543 Priority, the main contents of this application are hereby incorporated by.

Technical field

The present invention relates generally to for the apparatus and method treating cardiac valve dysfunctions, more specifically it relates to a kind of There is provided under lobe（sub-valvular）Under leaflet support and lobe, device supports thus helping prevent in passive manner or mitigating The apparatus and method that cardiac valve backflows.

Background technology

Valvular opening and closing are primarily due to pressure difference and occur.For example, mitral beat on an off Close the pressure difference being because between left atrium and left ventricle and occur.In the relaxing period of ventricle, enter the left heart from pulmonary vein The venous return of the blood in room leads to the pressure of left atrium to exceed the pressure of left ventricle.Therefore, Bicuspid valve is opened and is allowed blood Enter left ventricle.Due to left ventricular contraction during ventricular systole, hence in so that the pressure within ventricle is increased to above the heart Pressure within room, and promote MC.

When high pressure exceedingly promotes valve leaflets produced by the contraction by left ventricle, leaflet can be led to overturn and take off Hang down.Under normal circumstances, the generation of this phenomenon, this papillary muscle can be prevented by the contraction of the papillary muscle in left ventricle By chordae tendineae（chords）It is connected with mitral leaflet.The contraction of papillary muscle is simultaneous with the contraction of left ventricle, from And enable the mitral leaflet of health to keep closing in systolic pressure peak value.

Different types of etiopathogenises can lead to Bicuspid valve to lose efficacy.For example, disease intrinsic from leaflet can extensively be arrived the reason mitral reflux Disease（For example, mainly due to the degenerative disease of the patient with mitral valve prolapse（degenerative disease））To function Property mitral reflux（FMR）, in Functional mitral regurgitation, although the anatomical structure of valve is normal, can be because of bundle Tie up and annular ex-pansion（tethering and annular dilatation）And it is impaired（stretched）.Although intrinsic disease In mitral reflux be rendered as leaflet disease initially, but treatment when most patient there occurs secondary annular ex-pansion. The most patient with mitral reflux includes the patient that those do not suffer from the intrinsic disease of leaflet, that is, those features Mitral reflux（FMR）Patient.

Functional mitral regurgitation（FMR）Corrective procedure based on the overcorrection of adjoint annular ex-pansion, utilize Reduced size, complete, rigid valvoplasty ring（annuloplasty ring）, to realize reducing annulus of mitral valve Diameter and be allowed for leaflet engage.Although demonstrating mitral reflux by operation can be corrected completely, Because left atrium constantly expands or deformation can cause the constraint further of mitral leaflet, therefore valvoplasty repairs it Afterwards, a large amount of recurrences of common mitral reflux（25%）.

Content of the invention

According to an aspect of the invention, it is provided a kind of dress for treatment by the blood reflux of diseased cardiac valve Put.Described diseased cardiac valve includes organ under valve annulus, anterior valve leaflets, rear portion valve leaflets and lobe.Described device bag Include support member and at least one ring lower support element of general toroidal, the support member of described ring lower support element and described general toroidal It is securely associated to.The support member of described general toroidal at least has the first pars intermedia, the second pars intermedia and rearward end, described rear end Portion extends between described first pars intermedia and described second pars intermedia.Described rearward end is provided connected to described diseased heart The rear portion of the described valve annulus of valve.Described ring lower support element is securely connected to the support of described general toroidal in primary importance Part.At least one ring lower support element described is set to positioned at described rear portion valve leaflets and described front portion valve leaflets at least one The lower section of person and extend, and pass through under at least one lobe structure or be located at the rear of structure under at least one lobe and extend.

According to a further aspect in the invention, there is provided a kind of dress for treatment by the blood reflux of diseased cardiac valve Put.Described diseased cardiac valve includes organ under valve annulus, anterior valve leaflets, rear portion valve leaflets and lobe.Described device bag Include support member, the first ring lower support element and the second ring lower support element of general toroidal.The support member of described general toroidal is at least There is the first pars intermedia, the second pars intermedia and rearward end, described rearward end is in described first pars intermedia and described second pars intermedia Between extend.Described rearward end is provided for connecting the rear portion of the extremely described valve annulus of described diseased cardiac valve.Described One ring lower support element is securely connected to the support member of described general toroidal in primary importance.Described second ring lower support element is Two positions are securely connected to the support member of described general toroidal.Described first ring lower support element and described second ring lower support element It is set to extend positioned at the lower section of at least one of described rear portion valve leaflets and described front portion valve leaflets, and pass through extremely Structure or be located at the rear of structure under at least one lobe and extend under a few lobe.

According to a further aspect in the invention, there is provided a kind of side for treatment by the blood reflux of diseased cardiac valve Method.Described diseased cardiac valve includes organ under valve annulus, anterior valve leaflets, rear portion valve leaflets and lobe.Methods described One step includes providing step, provides a kind of device in this step, this device include general toroidal support member and with At least one ring lower support element that the support member of described general toroidal is firmly attached.The support member of described general toroidal at least has Have the first pars intermedia, the second pars intermedia and rearward end, described rearward end described first pars intermedia and described second pars intermedia it Between extend.Then, the step of methods described includes Connection Step, in this step by the support member of described general toroidal connect to The described valve annulus of described diseased cardiac valve so that at least one ring lower support element described be located at described rear portion valve leaflets and Described front portion valve leaflets the lower section of at least one and pass through at least one lobe under structure or be located at least one lobe under The rear of structure and extend, to prevent or substantially to reduce the blood reflux by diseased cardiac valve.

Brief description

By reading description referring to the drawings, for the technical staff in field involved in the present invention, this Bright above and other feature will be apparent from, wherein：

Figure 1A is to be configured to according to an aspect of the present invention treat the device through Bicuspid valve blood reflux Axonometric chart；

Figure 1B is the top view of the device in the mitral Figure 1A be implanted to illness；

Fig. 1 C is the top view showing the device being easy to be connected to device 10 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 sectional view cut open along the 1E-1E line in Fig. 1 D；

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

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

Fig. 1 H is the perspective view as part thereof of governor motion included by the device showing in Figure 1A；

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

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

Fig. 1 K is that the percutaneous showing the device in Fig. 1 J are adjusted（percutaneous adjustment）Human heart Sectional view；

Fig. 2 is the sectional view in the left side showing human heart；

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

Fig. 3 B is the top view showing the device being implanted in mitral Fig. 3 A of illness；

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

Fig. 3 D is the top view showing the device being implanted in mitral Fig. 3 C of illness；

Fig. 4 A is the top view showing the alternative structure of device being implanted in mitral Figure 1A of illness；

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

Fig. 4 C is the sectional view showing the device being implanted in mitral Fig. 4 A- Fig. 4 B of illness；

Fig. 4 D is the axonometric chart showing the device being implanted in mitral Fig. 4 A- Fig. 4 B of illness；

Fig. 4 E is mitral annular reinvented and the ring lower horizontal plane showing in Fig. 4 C- Fig. 4 D（levels）Signal Figure；

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

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

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

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

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

Fig. 7 A is the top view of the alternative structure showing 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 being constructed according to a further aspect in the invention；

Fig. 8 B is the side view of the amplification of the end section showing the measuring appliance in Fig. 8 A；

Fig. 8 C is the top view of the measurement part including the measuring appliance in Fig. 8 A；

Fig. 8 D is the top view showing the device connecting to the Figure 1A transmitting utensil or support member；

Fig. 8 E is to show the transmission utensil of device or support member connecting to Figure 1A（Fig. 8 D）Part amplification three-dimensional Figure；

Fig. 9 A is the axonometric chart showing the device being implanted in mitral Fig. 7 A of illness；

Fig. 9 B is the sectional view of device in Fig. 9 A；

Fig. 9 C is display along posterior mitral valve leaflet（the posterior mitral leaflet）Lower free margins extend The sectional view of rear support member under the ring of the device in Fig. 9 B；

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

Figure 10 B is the axonometric chart showing the device being implanted in mitral Figure 10 A of illness；

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

Figure 11 B is the axonometric chart showing the device being implanted in mitral Figure 11 A of illness；

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

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

Figure 12 C is the axonometric chart showing the device being implanted in mitral Figure 12 A- Figure 12 B of illness；

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

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

Figure 14 A is to be configured to according to a further aspect in the invention treat the device through tricuspid blood reflux Top view；

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 showing the device in Figure 14 A；

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

Figure 15 is the sectional view of human heart；

Figure 16 A is the axonometric chart showing the device being implanted in tricuspid Figure 14 A of illness；

Figure 16 B is the tricuspid bottom outward appearance showing in Figure 16 A（inferior aspect）Axonometric chart；

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

Figure 17 B is the axonometric chart of the device in the tricuspid Figure 17 A be implanted to illness；

Figure 17 C is the axonometric chart showing the tricuspid bottom outward appearance in Figure 17 B；

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

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

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

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

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

Specific embodiment

The present invention relates generally to for the apparatus and method treating cardiac valve dysfunctions, more specifically it relates to a kind of There is provided sub- valve leaflets to support and sub- valve device supports the device passively to help prevent or to mitigate cardiac valve to backflow And method.Present invention generally provides a kind of valvoplasty loop systems, this system has ring lower part（infra-annular）, from By device supporting mechanism under the leaflet on side and valve to prevent leaflet in systole from fettering and to backflow.Advantageously, originally Invention provides cardiac valve（Bicuspid valve and Tricuspid valve）The synchronous annular of heart reconstruction and ring lower horizontal plane so that leaflet seam Horizontal plane and angle correctization and normalization, prevent leaflet constraint and eliminate valvular regurgitation through asking of recurring after a while Topic.Therefore, the treatment that the present invention provides is not only for valvular regurgitation（Such as Functional mitral regurgitation）, it is also directed to because of expanding The valvular regurgitation that cardiomyopathy and ischemic cardiomyopathy lead to.

As the representative of one aspect of the present invention, Figure 1A-Fig. 1 E illustrates for treatment through such as Bicuspid valve 12（Figure 2）The blood reflux of diseased cardiac valve device 10.As shown in Fig. 2 Bicuspid valve 12 be located at left atrium 14 and left ventricle 16 it Between, and for stoping the blood back flow entering left atrium in systole from left ventricle.Mitral valve 12 has D-ring 18, this D-ring 18 defines the opening between left atrium 14 and left ventricle 16, and Bicuspid valve 12 includes front portion positioned opposite 20 and rear portion 22.Bicuspid valve 12 is formed by two leaflets, i.e. anterior leaflet 24 and rear portion leaflet 26, and each leaflet includes Upper face 28 positioned opposite and lower surface 30.Anterior leaflet 24 is along the planar base substantially of D-shaped annulus of mitral valve 18 In two fibrous triangles（Not shown）Between extend.Rear portion leaflet 26 is around the curve part of the D-shaped annulus of mitral valve 18 of Bicuspid valve 12 Divide and extended with circular arc.Chordae tendineae 32 and chordae tendineae 32 ' are respectively in lower free margins 34 and the rear portion Bicuspid valve of anterior mitral leaflet 24 The lower free margins 36 of leaflet 26 extend to the papillary muscless 38 and papillary muscless 38 ' of left ventricle 16.

Reference picture 1A- Fig. 1 E, device 10 includes the support member 40 of general toroidal and is attached firmly to this support member 40 At least one ring lower support element（Back support member 42 under such as ring）.Device 10 has the saddle shapes phase with annulus of mitral valve 18 Corresponding three-dimensional（3D）Shape.During the physiological movement of the complexity related to cardiac cycle, the 3D shape of device 10 makes Obtain the 3D shape that device 10 can compensate Bicuspid valve 12.So, when device 10 is implanted to Bicuspid valve 12（For example it is implanted to two In cusp ring 18 or be implanted on annulus of mitral valve 18）When, can eliminate because of device 10 to Valvectomy and/or annular folding The demand of folded art, thus help in passive manner provide leaflet to support so that will not become during cardiac cycle Shape.

The support member 40 of general toroidal at least includes the first pars intermedia 44, the second pars intermedia 46 and in the first pars intermedia 44 And second rearward end 48 extending between pars intermedia 46.Terminology used herein " general toroidal " can be used for description and has circle Or the annular support member 40 of semicircular structure.Therefore, term " general toroidal " refer to annular support member 40 be completely annular, Completely rounded, oval, part circular, C-shaped, D-shaped, U-shaped etc..Terminology used herein " substantially " also refer to action, Feature, performance, state, structure, project, result complete or close to complete scope or degree.For example, annular support member 40 is " substantially " annular is it is meant that this support member is complete annular or close to complete annular.Definite with absolute circular phase ratio Admissible deformation extent be likely to be dependent on specific linguistic context.However, in general, obtained with absolute and complete annular Result compare, approximate annular will have identical whole structure.

As shown in figures ia-c, the support member 40 of general toroidal can be complete annular, and includes：In the middle of first Portion 44；Second pars intermedia 46；Rearward end 48, this rearward end 48 extends between the first pars intermedia 44 and the second pars intermedia 46；With 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 Ground arrangement.Alternately, as shown in Fig. 1 F- Fig. 1 G, the support member 40 of general toroidal can be part-toroidal, and includes：The One pars intermedia 44；Second pars intermedia 46；And rearward end 48, this rearward end 48 the first pars intermedia 44 and the second pars intermedia 46 it Between extend.

Leading section 50 and rearward end 48 are configured to be respectively connecting to the front portion 20 of annulus of mitral valve 18 and rear portion 22.Example As rearward end 48, the first pars intermedia 44, the second pars intermedia 46 form continuous arc, so that rearward end 48 is with respect to front End 50 has concave shape.Similarly, leading section 50, the first pars intermedia 44, the second pars intermedia 46 form continuous arc, from And make leading section 50 have convex shape with respect to rearward end 48.As shown in figure ip, the support member 40 of general toroidal also includes Longitudinal axes L A.The support member 40 of general toroidal can have rigid or semirigid structure.

Device 10 also includes back support member 42 under at least one ring, and under ring, back support member 42 is firm in primary importance 52 Be attached directly to the support member of general toroidal.For example, as shown in Figure 1A-Fig. 3 B, device 10 only includes rear portion under a ring Support member 42.When device 10 is implanted on annulus of mitral valve 18 or is implanted to around annulus of mitral valve 18, back support member under ring 42 size, shape and structure setting are to extend below rear portion mitral leaflet 26, and pass through knot under at least one lobe Structure or be located at the rear of structure under at least one lobe and extend.Under the lobe related to Bicuspid valve 12, structure includes but is not limited to： The lower free margins 36 of the bottom outward appearance of rear portion leaflet 26, such as rear portion leaflet 26；The bottom outward appearance of anterior leaflet 24, such as anterior The lower free margins 34 of leaflet 24；Chordae tendineae 32, this chordae tendineae 32 is related to rear portion leaflet 26；Chordae tendineae 32 ', this chordae tendineae 32 ' and anterior lobe Leaf 24 is related；One or more papillary muscless 38, this papillary muscles 38 is related to the chordae tendineae 32 of rear portion leaflet 26；One or more Papillary muscless 38 ', this papillary muscles 38 ' is related to the chordae tendineae 32 ' of anterior leaflet 24；And joint portion.

The shape of back support member 42, structure under ring, may be sized to through following structure or in following structure Rear extend：Structure, the lobe of a single part under structure under single complete lobe, two or more complete lobe Structure under the lobe of lower structure or two or more a part.For example, under ring, the structure of back support member 42 can construct Be to extend below rear portion mitral leaflet 26, and pass through rear portion mitral leaflet 26 a part for lower free margins 36 or Person is located at the rear of a part for lower free margins 36 of rear portion mitral leaflet 26 and extends, alternately, just through rear portion two The part for lower free margins 36 of cusp leaflet 26 and extend or be only positioned at the lower free margins 36 of rear portion mitral leaflet 26 A part rear and extend.In addition, back support member 42 is it is so structured that prolong below rear portion mitral leaflet 26 under ring Stretch, and pass through complete chordae tendineae 32 and/or the papillary muscless 38 related to rear portion mitral leaflet 26（One or more）Or Positioned at complete chordae tendineae 32 and/or the papillary muscless 38 related to rear portion mitral leaflet 26（One or more）Rear and extend, Alternately, through a part or the chordae tendineae 32 being located at rear portion mitral leaflet 26 of the chordae tendineae 32 of rear portion mitral leaflet 26 The rear of a part and extend.In these cases two kinds or in the case of one of which, back support member 42 under ring Shape reflects the 3D shape of rear portion mitral leaflet 26, the especially three-dimensional of the lower free margins 36 of rear portion mitral leaflet 26 Shape, to prevent or to slow down limited by the action of rear portion mitral leaflet 26, and in turn, prevents or slows down through Bicuspid valve 12 The backflowing of blood.

As shown in figure ip, under ring back support member 42 with angle A and apart from D the support member 40 in general toroidal longitudinal axiss The lower section of line LA extends.Under ring, the angle A of back support member 42 enables back support member 42 under ring to promote optimal leaflet Engage.In one embodiment of the invention, angle A can be between about 10 ° to about 60 °（Such as about 30 °）.Similar Ground, enables to back support member 42 under ring apart from D and extends in the lower section of rear portion mitral leaflet 26, so that rear portion under ring Support member 42 can promote optimal leaflet to engage.

Under ring, back support member 42 can have rigid or semirigid structure.For example, when under ring back support member 42 have When having semirigid structure, under ring back support member 42 flexible to or can be adjusted to diverse location.Back support member 42 under ring Governor motion 54 can additionally or alternatively be included（Fig. 1 H- Fig. 1 K）, governor motion 54 can be selectively adjusted under ring Back support member 42 is with respect to the position of longitudinal axes L A.As shown in Figure 1 I, device 10 implantation before, when and/or afterwards, Governor motion 54 allows to be selectively adjusted under ring the angle A of back support member 42 and/or apart from D and/or lateral attitude LP.

Engage to improve leaflet, can be according to organ structure under leaflet organizational structure, lobe（Such as chordae tendineae 32 and chordae tendineae 32 ' and papillary muscless 38 and papillary muscless 38 '）And/or free margins leaflet engagement angles, the angle A to back support member under ring 42 And/or be selectively adjusted apart from D and/or lateral attitude LP.Lateral attitude LP refers to back support member 42 phase under ring Support member 42 rearward end 48 for general toroidal and along parallel with longitudinal axes L A（Or it is almost parallel）Axle side To position.As shown in figure ij, can operate governor motion 54 with by the lateral attitude LP of back support member under ring 42 adjust to Default position（Indicated by arrow and dotted line）.For example, device 10 can include three default positions（By " 1 " " 2 " " 3 " Indicated）.It is to be understood that governor motion 54 can be operated with by the angle A of back support member under ring 42 and/or apart from D Adjust to preset position.

In one embodiment of the invention, governor motion 54 can include actuator 56（As shown in Fig. 1 H and Fig. 1 J）, Such as it is at least partially disposed in the support member 40 of general toroidal and may be operably coupled to back support member 42 under ring Screw（Such as ratchet-like mechanism）.Can optionally operate（Such as rotate, push away, draw）Actuator 56 is to adjust（Such as increase Add deduct few）The angle A of back support member 42 and/or apart from D and/or lateral attitude LP under ring.

Regulation instrument 58 can be passed through（Fig. 1 I- Fig. 1 K）It is selectively adjusted actuator 56.The structure of regulation instrument 58 will Depending on the opportunity needing the position of back support member 42 under regulation ring.For example, need under regulation ring in cardiac surgical procedure During the position of back support member 42, the structure of regulation instrument 58 can be configured to similar screw-driven part or other similar portions Part, thus surgeon can be easily handheld and be operated（Fig. 1 J）.Alternately, need after implantation of the device 10 Under regulation ring during the position of back support member 42, the structure of regulation instrument 58 can be configured to conduit, thus allowing under ring Back support member 42 enters percutaneous and adjusts（Fig. 1 I and Fig. 1 K）.

In general, in the cardiac surgical procedure under direct-view, can be by using percutaneous crossedpath（Fig. 1 K）, use Electromagnetic force（Hereinafter describe）And/or under echocardiographic guiding, optionally operate actuator 56.For example, adjust instrument 58 can by be magnetically coupled to actuator 56 and by indwelling（be left）, and the externalizing through left atrium wall （externalized）, thus, after departing from the extracorporeal circulation stage（after coming off cardiopulmonary bypass）, can be by operating actuator come back support member under regulation ring 42（Such as under echocardiographic guiding）, with Obtain the best angle of leaflet joint and therefore eliminate Bicuspid valve and/or tritubercular cycloid.Hereafter, described magnetic force can be interrupted And remove regulation instrument 58.

It is understood that governor motion 54 can have others can be selectively adjusted back support member 42 under ring Structure.For example, under ring, a completely or only part for back support member 42 can be made up of shape-memory material, such that it is able to logical Cross and optionally apply energy to thereon and adjust the shape of this shape-memory material（And direction）.If over time passage Bicuspid valve and/or SAN GUAN lobe backflow and recur, then governor motion 54 can advantageously allow for back support member under ring 42 Position is adjusted and need not implement extra operation on heart.

Back support member 42 under ring（Fig. 1 C）Including junction surface 60 and integral part of cervical region 62, cervical region 62 is from junction surface 60 Extend to primary importance 52.Junction surface 60 is configured to and form touch under at least one lobe, and typically has elongated S-shaped knot Structure.It is transversal that bonding part 60 can have circular cross-sectional profile, V-arrangement cross-sectional profiles, elliptic cross-section facial contour, square The cross-sectional profiles of facial contour or arbitrarily other geometries.Junction surface 60 can have the structure of arc.For example, as Fig. 1 C institute Show, junction surface 60 can have convex shape with respect to the rearward end 48 of the support member 40 of general toroidal.

Cervical region 62 is formed with junction surface 60.Cervical region 62 is set in mitral leaflet 24 and mitral leaflet 26 Extend between one of corresponding joint close position or approx between this joint close position.So, primary importance 52 is typically But it is optionally adjacent with one of the joint close position of mitral leaflet 24 and mitral leaflet 26.As shown in Figure 1B-Fig. 1 C, Cervical region 62 includes the first end 64 being oppositely arranged and the second end 66, first end 64 and the second end 66 respectively with substantially ring The support member 40 of shape（Such as in primary importance 52）Form with junction surface 60.For example, the first end 64 of cervical region 62 with Second pars intermedia 46 of the support member 40 of general toroidal forms.

A completely or only part for device 10 is made up of rigidity or semi-rigid material, and this material can allow manual deformation, And still hard enough after the implantation further deformed with bearing（Such as, when suffering from normal physiological stress）.For structure The nonrestrictive example making the material of device 10 can include biocompatibility medical metal, such as metal alloy, plastics, nickel Titanium alloy, rustless steel, titanium, pyrolytic carbon, cochrome etc..

A completely or only part for cover layer 68 cladding system 10 of biocompatible materialses can be used（Fig. 1 E）.Biofacies The cover layer 68 of capacitive material can include synthetic material, such as, terylene（DACRON）, braiding velvet, polyurethane, polytetrafluoroethyl-ne Alkene, expanded PTFE or heparin coating fiber etc..Alternately, cover layer 68 can include biomaterial, such as cattle or horse Pericardium, alloplast, sick body graft or cell construction tissue.Cover layer 68 can cover the support member of general toroidal 40 and/or ring under the inner surface of back support member 42, under the support member 40 of general toroidal and/or ring back support member 42 appearance Face, or can be wound around described inner surface and described outer surface.For example, as referring to figure 1e, cover layer 68 can set It is set to whole circumference of the support member 40 around general toroidal.It is understood that cover layer 68 can appointing with cladding system 10 What part.

Equally as shown in Figure 1 C, cover layer 68 can include at least one labelling 70, be conducive to by device 10 connect to Annulus of mitral valve 18.Labelling 70 can include preformed hole, to be conducive to suture positioning and/or color instruction, thus indicating suture Position is so that the device 10 in vivo is consolidated.It is understood that can be in the horizontal plane of trigonum（at the level of the trigones）（Not shown）A part for device 10 is amplified or strengthens, with extra by introducing Around desired part（One or more）Biocompatibility cover layer come to promote implantation and leaflet engage.

Can use being capable of eluting（eluting）Enter the curative of one or more combination of chambers of the heart chamber or cardiac muscular tissue Agent is processed at least a portion of device 10.Healing potion is prevented from multiple pathological states, the including but not limited to rhythm of the heart Not normal, thrombosiss, valvular stenosiss, apoptosis and inflammation.Correspondingly, healing potion can include anti-arrhythmic Agent, anticoagulant, antioxidant, fibrinolytic, steroid, anti-apoptotic medicament, anti-undue growth medicament（That is, it is prevented from Epithelial cell undue growth）At least one of and/or antibiotic medicine.Alternatively, or in addition, healing potion can be treated or anti- Only other diseases or lysis, such as microorganism infection and heart failure.In these examples, healing potion can include resisting Microbial reagent（Such as, antibiotic）, the biological preparation of cardiac tonic, chronotropic medicament and/or cell or albumen etc..

Fig. 3 A- Fig. 3 D illustrates another aspect of the present invention.In addition to described below, the device 10 shown in Fig. 3 A- Fig. 3 D_a Identical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 3 A- Fig. 3 D, with the structure identical structure in Figure 1A-Fig. 1 I Using identical reference, and the subsidiary subscript " a " of structure that is similar to the structure in Figure 1A-Fig. 1 I but differing.Can manage Solution, device 10_aCan be made up of any materials set forth above, and device 10_aAbove-described biofacies can be included The cover layer 68 of capacitive material and/or healing potion（One or more）.

As shown in Fig. 3 A- Fig. 3 B, back support member 42 under ring_aCan have bifurcation structure, including arrange at intervals First junction surface 72 and the second junction surface 74.First junction surface 72 and the second junction surface 74 can be spaced apart, and each other axially Ground skew（With respect to central shaft CA）Apart from D1（Fig. 3 A）.In general, can be according to mitral anatomy, patient apart from D1 The particular valve incompetence being suffered from and other factors and change.Especially, can become apart from D1 to turn to promotes first to connect Contact between conjunction portion 72 and the second junction surface 74 and structure under one or more lobes.For example can change apart from D1 so that Obtain the part that the first junction surface 72 contacts the lower free margins 36 of rear portion mitral leaflet 26, and the second junction surface 74 is connect A part for tactile chordae tendineae 32 and/or the papillary muscless 38 related to rear portion mitral leaflet 26（One or more）.

As shown in Fig. 3 C- Fig. 3 D, under ring, back support member 42 alternatively can have arc, loop configuration, this annular Structure includes the hole 134 through this extensibility of structure.Under ring, the junction surface 60 of back support member 42 can be with respect to general toroidal The leading section 50 of support member 40 has concave shape.In addition, the junction surface 60 of back support member 42 can pass through at least one under ring Under individual lobe structure completely or only a part and extend, or be located at least one lobe under structure completely or only a part after Just extend.

Fig. 4 A- Fig. 4 E illustrates another aspect of the present invention.In addition to described below, the device 10 shown in Fig. 4 A- Fig. 4 E_b Identical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 4 A- Fig. 4 E, with the structure identical structure in Figure 1A-Fig. 1 I Using identical reference, and the subsidiary subscript " b " of structure that is similar to the structure in Figure 1A-Fig. 1 I but differing.Can manage Solution, device 10_bCan be made up of any materials set forth above, and device 10_bAbove-described biofacies can be included The cover layer 68 of capacitive material and/or healing potion（One or more）.

As can be seen from figures 4a-b, back support member 42 under ring_bCan have bifurcation structure, including arrange at intervals First junction surface 72 and the second junction surface 74.First junction surface 72 and the second junction surface 74 can be spaced apart, and each other radially Ground skew（With respect to central shaft CA）Apart from D2.In general, can be suffered from according to mitral anatomy, patient apart from D2 Particular valve incompetence and other factors and change.Especially, can become apart from D2 and turn to promotion the first junction surface 72 And second contact between junction surface 74 and structure under one or more lobes.For example, can change apart from D2 so that One junction surface 72 contacts a part for lower free margins 34 for anterior mitral leaflet 24 and/or related to anterior mitral leaflet 24 Chordae tendineae 32 '（And/or one or more papillary muscless 38 '）, and make the second junction surface 74 contact rear portion mitral leaflet 26 A part for lower free margins 36 and/or the chordae tendineae 32 related to rear portion mitral leaflet 26（And/or one or more papillary muscless 38′）.Shown in Fig. 4 C- Fig. 4 E and as described in following more details, two horizontal planes of heart reconstruction can be in device 10_bFirmly Produce during ground implantation.

Fig. 5 A- Fig. 5 B illustrates another aspect of the present invention.In addition to described below, the device 10 shown in Fig. 5 A- Fig. 5 B_c Identical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 5 A- Fig. 5 B, with the structure identical structure in Figure 1A-Fig. 1 I Using identical reference, and the subsidiary subscript " c " of structure that is similar to the structure in Figure 1A-Fig. 1 I but differing.Can manage Solution, device 10_cCan be made up of any materials set forth above, and device 10_cAbove-described biofacies can be included The cover layer 68 of capacitive material and/or healing potion（One or more）.

Device can include the ring lower support element 76 of Y shape or fork shape, and this ring lower support element 76 includes front support under ring Portion 78, and with back support portion 80 under front support portion 78 ring positioned opposite under this ring.Under front support portion 78 and ring under ring Back support portion 80 is integrally attached to by common cervical region 82 at the primary importance 52 of support member 40 of general toroidal.First Putting 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 Put.

As shown in Figure 5A, under ring, under front support portion 78 and ring, each in back support portion 80 includes arranging at intervals The first junction surface 72 and the second junction surface 74.First junction surface 72 and the second junction surface 74 can be spaced apart, and axle each other To ground skew（With respect to central shaft CA）Apart from D1.Alternately, back support portion 80 under front support portion 78 and ring under ring Each can have elongated, annular structure（Fig. 5 B）.Front support portion 78 and back support portion under ring 80 radial direction under ring Ground D2 spaced apart.It is understood that D1 and/or D2 can be changed to optimize leaflet joint.

Fig. 6 A- Fig. 6 C illustrates another aspect of the present invention.In addition to described below, the device 10 shown in Fig. 6 A- Fig. 6 C_d Identical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 6 A- Fig. 6 C, with the structure identical structure in Figure 1A-Fig. 1 I Using identical reference, and the subsidiary subscript " d " of structure that is similar to the structure in Figure 1A-Fig. 1 I but differing.Can manage Solution, device 10_dCan be made up of any materials set forth above, and device 10_dAbove-described biofacies can be included The cover layer 68 of capacitive material and/or healing potion（One or more）.

As shown in Fig. 6 A- Fig. 6 C, device 10_dRear portion and front support member under support member 40 including general toroidal and ring 180, 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 include：First pars intermedia 44；Second pars intermedia 46；Rearward end 48, this rearward end 48 is in first Between between portion 44 and the second pars intermedia 46 extend；And leading section 50, this leading section 50 is in the middle of the first pars intermedia 44 and second Extend between portion 46, and with rearward end 48 is oppositely arranged.Alternately, the support member 40 of general toroidal can be part ring Shape, and include：First pars intermedia 44；Second pars intermedia 46；And rearward end 48, this rearward end 48 is in the first pars intermedia 44 He Extend between second pars intermedia 46.

Leading section 50 and rearward end 48 are configured to be respectively connecting to the front portion 20 of annulus of mitral valve 18 and rear portion 22.Example As, rearward end 48, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc so that rearward end 48 with respect to Leading section 50 has concave shape.Similarly, leading section 50, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc Shape, so that leading section 50 has convex shape with respect to rearward end 48.Similar to the device 10 shown in Fig. 1 D, device 10_d The support member 40 of general toroidal also include longitudinal axes L A.The support member 40 of general toroidal can have rigid or semi-rigid Structure.

When device 10_dWhen being implanted on annulus of mitral valve 18 or being implanted to around annulus of mitral valve 18, rear portion and front portion under ring The size of support member 180, shape and structure setting are positioned at rear portion mitral leaflet 26 and anterior mitral leaflet 24 lower section Extend, and pass through under at least one lobe structure or be located at the rear of structure under at least one lobe and extend.Under ring rear portion and Front support member 180 is attached directly to the support member 40 of general toroidal securely in primary importance 52.For example, as Fig. 6 A institute Show, under ring, rear portion and front support member 180 are attached directly to the second pars intermedia 46 securely.Although not showing, permissible It is understood by, alternately, under ring, rear portion and front support member 180 can be attached directly to the first pars intermedia 44 securely.

Under ring, rear portion and front support member 180 include hook-type junction surface 182, and it is straight that cervical region 62 is passed through at this hook-type junction surface 182 Ground connection is integrally attached to the support member 40 of general toroidal.Junction surface 182 also includes the first junction surface 184, the second junction surface 186 And between the first junction surface 184 and the second junction surface 186 extend bending section 188.First junction surface 184 and the second joint The each in portion 186 has continuous arc（Or arch）Structure, to be configured to pass through under at least one lobe structure or to be located at The rear of structure under at least one lobe and extend.First junction surface 184 and the second junction surface 186 are permissible（Respectively）With respect to substantially The leading section 50 of the support member 40 of annular has concave shape or convex shape.

First junction surface 184 is configured to pass through structure or the rear being located at structure under at least one lobe under at least one lobe And extend, such as：The bottom outward appearance of rear portion leaflet 26, the such as lower free margins 36 of rear portion leaflet 26；Related to rear portion leaflet 26 Chordae tendineae 32；The one or more papillary muscless 38 related to the chordae tendineae 32 of rear portion leaflet 26；And the combination of the above part.Separately Outward, the second junction surface 186 is configured to pass through structure under at least one lobe and extends or be located under at least one lobe after structure Just extend, such as：The bottom outward appearance of anterior leaflet 24, the lower free margins 34 of such as anterior leaflet 24；Related to anterior leaflet 24 Chordae tendineae 32 '；The one or more papillary muscless 38 ' related to the chordae tendineae 32 ' of anterior leaflet 24；And the group of the above part Close.

First junction surface 184 and the second junction surface 186 may be located at identical transverse plane（lateral plane）（That is, Below longitudinal axes L A and parallel or substantially parallel with longitudinal axes L A the plane extending）In, or, alternately, First junction surface 184 and the second junction surface 186 are offset from one another with respect to central shaft CA.So, the first junction surface 184 and second connects Conjunction portion 186 may be positioned such that structure under the identical or different corresponding lobe of contact.For example, the first junction surface 184 and the second junction surface 186 are offset from one another, and the first junction surface 184 is configured to pass through the bottom outward appearance of rear portion leaflet 26（Such as, rear portion leaflet 26 lower from By side 36）Or be located at the rear of bottom outward appearance of rear portion leaflet 26 and extend, and the second junction surface 186 be configured to pass through with The chordae tendineae 32 ' of anterior leaflet 24 correlation or be located at the rear of chordae tendineae 32 ' related to anterior leaflet 24 and extend.

Fig. 6 B- Fig. 6 C illustrates the alternative structure of rear portion and front support member 180 under ring.As shown in Figure 6B, after under ring The junction surface 182 of portion and front support member 180 can have bifurcation structure, including the first fastener 190 arranging at intervals With the second fastener 192.First fastener 190 and the second fastener 192 can be spaced apart, and axially offset each other（Phase For central shaft CA）Apart from D1.In general, the specific lobe that can be suffered from according to mitral anatomy, patient apart from D1 Film incompetence and other factors and change.Especially, can become apart from D1 to turn to promotes the first fastener 190 and second to connect Contact between component 192 and structure under one or more lobes.As described above, the first fastener 190 and the second fastener 192 Each includes the first junction surface 184 and the second junction surface 186.

As shown in Figure 6 C, under ring, the junction surface 182 of rear portion and front support member 180 can alternatively have arc, ring Shape structure, this loop configuration includes the hole 134 through this extensibility of structure.The junction surface 182 of annular can include and common arc First fastener 190 of bending 194 connection and the second fastener 192.First fastener 190 and the second fastener 192 can between Separate, and axially offset each other（With respect to central shaft CA）Apart from D1.In general, can be according to Bicuspid valve solution apart from D1 Cut open structure, particular valve incompetence that patient is suffered from and other factors and change.

It is understood that with shown in Figure 1A-Figure 1B and as devices discussed above 10, device 10_dCan be extraly Or optionally include other features.For example, device 10_dCan include：Governor motion 54；The cover layer of biocompatible materialses 68；It is easy at least one labelling 70 device being connected to annulus of mitral valve 18；And/or a kind of healing potion or multiple curative The combination of agent.

Fig. 7 A- Fig. 7 C illustrates another aspect of the present invention.In addition to described below, the device 10 shown in Fig. 7 A- Fig. 7 C_e Identical with the structure of the device 10 shown in Figure 1A-Fig. 1 I.In Fig. 7 A- Fig. 7 C, with the structure identical structure in Figure 1A-Fig. 1 I Using identical reference, and the subsidiary subscript " e " of structure that is similar to the structure in Figure 1A-Fig. 1 I but differing.Can manage Solution, device 10_eCan be made up of any materials set forth above, and device 10_eAbove-described biofacies can be included The cover layer 68 of capacitive material and/or healing potion（One or more）.

As shown in Fig. 7 A- Fig. 7 C, device 10_eIncluding back support member 42 ' under the support member 40 of general toroidal, the first ring with And second back support member 42 under ring ".The support member 40 of general toroidal can be complete ring, and includes：First pars intermedia 44；Second pars intermedia 46；Rearward end 48, this rearward end 48 extends between the first pars intermedia 44 and the second pars intermedia 46；Front end Portion 50, this leading section 50 extends between the first pars intermedia 44 and the second pars intermedia 46, and positioned opposite with rearward end 48.Can Selection of land, class annular support member 40 can be part-toroidal, and includes：First pars intermedia 44；Second pars intermedia 46；And rear end Portion 48, this rearward end 48 extends between the first pars intermedia 44 and the second pars intermedia 46.

Leading section 50 and rearward end 48 are configured to be respectively connecting to the front portion 20 of annulus of mitral valve 18 and rear portion 22.Example As, rearward end 48, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc so that rearward end 48 with respect to Leading section 50 has concave shape.Similarly, leading section 50, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc Shape, so that leading section 50 has convex shape with respect to rearward end 48.As seen in figure 7 c, the support member 40 of general toroidal Including longitudinal axes L A.The support member 40 of general toroidal can have rigid or semirigid structure.

When device 10_eWhen being implanted on annulus of mitral valve 18 or being implanted to around annulus of mitral valve 18, under the first ring, rear portion is propped up The size of back support member 42 under support member 42 ' and the second ring ", shape and structure setting are below rear portion mitral leaflet 26 And extend, and pass through under at least one lobe structure or be located at the rear of structure under at least one lobe and extend.Under first ring Back support member 42 ' is attached directly to the support member 40 of general toroidal securely in primary importance 52, and under the second ring after Portion's support member 42 " is attached directly to the support member of general toroidal securely in the second position 84 different from primary importance 52 40.For example, as shown in Figure 7 A, under the first ring, back support member 42 ' is attached directly to the first pars intermedia 44 securely, and the Back support member 42 under bicyclo- " is attached directly to the second pars intermedia 46 securely.

Under back support member 42 ' and the second ring under first ring, back support member 42 is " respectively with angle A 1 and angle A 2 big Cause extended distance D3 and apart from D4 below longitudinal axes L A of support member 40 of annular.The angle of back support member 42 ' under first ring The angle A 2 of back support member 42 under degree A1 and the second ring " makes rear portion under back support member 42 ' and the second ring under the first ring prop up Support member 42 " can promote to optimize leaflet joint.In one embodiment of the invention, under the first ring back support member 42 ' angle One of angle A 2 of back support member 42 under degree A1 and the second ring " or both can be between about 10 ° to about 60 ° （Such as 30 °）.It is understood that angle A 1 can be identical or different with angle A 2.Similarly, apart from D3 with apart from D4 energy " a respective part is in rear portion mitral valve enough to make back support member 42 under back support member 42 ' and the second ring under the first ring The lower section of leaflet 26 extends, so that back support member 42 " can promote excellent under back support member 42 ' and the second ring under the first ring Change leaflet to engage.It is understood that can be identical or different with apart from D4 apart from D3.

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

It is understood that with shown in Figure 1A-Figure 1B and as devices discussed above 10, device 10_eCan be extraly Or optionally include other features.For example, device 10_eCan include：Governor motion 54；The cover layer of biocompatible materialses 68；It is easy at least one labelling 70 device being connected to annulus of mitral valve 18；And/or a kind of healing potion or multiple curative The combination of agent.

Fig. 8 A- Fig. 9 C illustrates another aspect of the present invention, including the blood of the mitral valve 12 by backflowing for treatment The method that liquid backflows.Although will be using the device 10 illustrated by Fig. 7 A- Fig. 7 B_eThe Therapeutic Method of the present invention to be described, but It is understood that any device described herein can be used for treating the blood reflux by ill mitral valve.For example, Device 10f shown in Figure 13 A- Figure 13 B can be used for treating dysfunction（Such as, limited by action）Anterior mitral leaflet 24.

As described above, device 10_e（Fig. 7 A- Fig. 7 B）Including D-ring support member 40, D-ring support member 40 has saddle type shape Shape, and in order to connect to the three dimensional structure size of annulus of mitral valve 18.Device 10_eAlso include rear portion under the first ring positioned opposite to prop up Back support member 42 under support member 42 ' and the second ring ", back support member 42 under shape back support member 42 ' and the second ring under the first ring " Form with the first pars intermedia 44 of the support member 40 of general toroidal and the second pars intermedia 46 respectively.Although Fig. 7 A- Fig. 7 B Do not show, but it is understood that, the cover layer 68 of biocompatible materialses can be used（Such as suture ring）Cladding system 10_eCompletely or only a part（Such as, the support member 40 of general toroidal）.

In order to treat the Bicuspid valve 12 backflowing, mitral size should be obtained first to determine device 10_eOptimum size. The dimensional measurement of Bicuspid valve 12 can be realized using valve measuring appliance.The example of valve size measuring appliance be it is well known that , the measuring device that can buy, such as bileaflet heart valve standard measurer can be included on market（ATS OPEN PIVOT STAND SIZER）The measuring device of series（ATS medical company, Minneapolis, Minnesota city）.In the present invention one In embodiment, the size of Bicuspid valve 12 can be by using Na Weiya（Navia）U.S. Patent application No.2009/0132036 （Hereinafter referred to as " 036 application "）Disclosed valve measuring appliance 86 measures, and entire contents are incorporated herein by reference.

As shown in Fig. 8 A- Fig. 8 C, measuring appliance 86 includes handle member 88, and handle member 88 is securely connected to measuring piece 90. Handle member 88 is included flexibly（fluidly）Connect to the handle 92 of distal connection 94.Handle 92 is used for guiding measuring utensil 86, and distal connection 94 is for being connected to measuring piece 90 by handle 92.Reference picture 8B- Fig. 8 C, measuring piece 90 includes 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 One pars intermedia 102 and the second pars intermedia 104 are oppositely arranged and extend between leading section 98 and rearward end 100.Annular brace Part 96 has planar structure（Fig. 8 B）, it is possible to have three-dimensional or saddle structure.

Measuring piece 90 defines longitudinal axis 106（Fig. 8 B）, and including leg portion 108, this leg portion 108 has Bindiny mechanism 110, is such as used for the hole with distal connection 90 cooperation of handle member 88.As shown in Figure 8 B, leg portion 108 exists Longitudinal axis 106 top of annular support member 96 extends.Measuring piece 90 also includes device under ring lower support element 112 and lobe（Such as, Chordae tendineae 32 and chordae tendineae 32 ' and/or one or more papillary muscless 38 and papillary muscless 38 '）, ring lower support element 112 is used for supporting heart Valve leaflets（Such as, the bottom outward appearance of rear portion leaflet 26, following free margins 36）.As shown in Figure 8 B, ring lower support element 112 is in ring Longitudinal axis 106 lower section of shape support member 96 extends.In one embodiment of the invention, ring lower support element 112 can be arranged It is to extend below rear portion leaflet 26, and engage with structure under at least one lobe.

In order that determine the size of Bicuspid valve 12 with measuring appliance 86, obtained by open procedures process and reach Bicuspid valve The path of film.In the process, mitral valve 12 is intuitively visual, therefore can be by measuring appliance 86 particularly measuring piece 90 It is positioned around the top outward appearance of Bicuspid valve 12.Using handle 92, left atrium 14, measuring appliance 86 are entered with guiding measuring part 90 It is positioned around Bicuspid valve 12 so that annular support member 96 contacts annulus of mitral valve 18 and ring lower support element 112 contacts from rear Or engage at least one lobe undertissue.

Next step, is monitored estimating anterior mitral leaflet 24 and rear portion two point to by the blood volume of Bicuspid valve 12 Joint between lobe leaflet 26.Various sizes of measuring piece 90 is placed on Bicuspid valve 12 until observing normal two substantially Cusp engages." normal blood flow " refer under physiologically normal pressure with physiologically normal speed unblocked pass through The biological valve of mammalss or the blood motion of vascular system.When observing that normal blood flow substantially passes through Bicuspid valve 12, note The size and selecting of record measuring piece 90 has the device 10 of the size matching with the size of measuring piece 90_eIn order to implement to plant Enter.It is understood that can be additionally or alternatively suitable by Bicuspid valve 12 to estimate using saline solution test Leaflet engages and blood flow.

Selecting the suitable device of size 10_eAfterwards, by device 10_eConnect to transmission utensil 114 or such as " 036 Shen On supporter disclosed in please "（Fig. 8 D- Fig. 8 E）.As shown in Fig. 8 D- Fig. 8 E, transmission utensil 114 or supporter include 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 intermedia 122 and the second pars intermedia 124 are oppositely arranged and extend between leading section 118 and rearward end 120.Pass Send utensil 114 or supporter to include bindiny mechanism 126, be such as used for connection to the hole of the distal connection 94 of measuring appliance 86 （Or similar structure）.Annular support member 116 has the cross section of C-shaped, and the cross section of this C-shaped defines passage 128（Figure 8E）.Passage 128 extends around the circumference of annular support member 116, and includes multiple extensions 130 to promote device 10_eEven It is connected to transmission utensil 114 or supporter.Transmission utensil 114 or supporter can include multiple stitching thread junction points 132, can wear Cross stitching thread junction point 132 and implement suture stitching thread with by device 10_eConnect to transmission utensil 114 or supporter.Can pass through Excise stitching thread on different stitching thread junction points 132 to remove device 10_e.

For starting apparatus 10_eImplant procedure, can be by silica gel tube（Do not show）Through Bicuspid valve 12 at least one Joint close position and be positioned at the rear of structure under at least one lobe, such as related to rear portion mitral leaflet 26 chordae tendineae 32 and Chordae tendineae 32 ' and/or one or more papillary muscless 38 and papillary muscless 38 '.When device 10_eWhen being securely connected to transmit utensil 114, Stitching thread（Not shown）It is arranged in annulus of mitral valve 18.Transmission utensil 114 is positioned around the top outward appearance of Bicuspid valve 12.Connect , stitching thread passes through one or more labellings 70（Such as, hole）, transmission utensil 114 joint Bicuspid valve 12 and device 10 simultaneously_e The support member 40 of general toroidal be pushed to annulus of mitral valve 18.Then, operation silica gel tube is so that the open end of silica gel tube engages the The far-end of at least one in back support member 42 under back support member 42 ' and the second ring under one ring ".Then silica gel tube is never connect Close end lightly to extract out, this will lead to back support member 42 under back support member 42 ' and the second ring under the first ring " through joint close portion Displacement is moved and is engaged from rear with structure under at least one lobe.Then disengage silica gel tube, then remove handle member 88 and draw Suture, so that device 10_eIt is positioned around Bicuspid valve 12 securely.After completing the tension of stitching thread, cut-out suture Line will be will transmit utensil 114 or supporter from device 10_eUpper separation simultaneously removes from left atrium 14.

Position securely with device 10e（Fig. 9 A- Fig. 9 C）, the horizontal plane of two heart reconstructions can be produced simultaneously.? Ring lower horizontal plane, by moving forward structure under lobe（One or more）, under back support member 42 ' and the second ring under the first ring after Portion's support member 42 " supports structure under at least one lobe（Such as, the lower free margins 36 of rear portion mitral leaflet 26 and rear portion leaflet The chordae tendineae 32 of 26 correlations and chordae tendineae 32 ' and/or the one or more papillary muscless 38 related to rear portion leaflet 26 and papillary muscless 38 '）, This will reduce limited by the action of rear portion mitral leaflet and prevent or alleviate the blood reflux by Bicuspid valve 12.In addition, passing through Forward（Or it is placed in the middle）Promote（Or it is mobile）Rear portion left ventricular wall can prevent from or alleviate expanding, by ischemic, the left side that cardiomyopathy leads to Ventricular Remodeling（That is, reversely reinvent mechanism）.In addition, on annular horizontal surface, promoting forward a part for rear portion left ventricular wall not Only can prevent or alleviate ischemic and expand the Ventricular Remodeling that cardiomyopathy leads to, and the Bicuspid valve of over time can be reduced The relapse rate that film backflows.Or on annular horizontal surface, device 10_eThree-dimensional saddle type geometry also reinvented annulus of mitral valve 18 And reduce the diameter of annular, engage such that it is able to improve leaflet.Based on device 10_eSuitable implantation, completing this program can To recover the normal blood flow by Bicuspid valve 12.

Figure 10 A- Figure 12 C illustrates other geometry deformations of the device 10 shown in Figure 1A-Fig. 1 D.For example, as Figure 10 A institute Show, back support member 42 under back support member 42 ' and the second ring under the first ring " the junction surface 60 of each can be alternatively There is fork configuration.Especially, each junction surface 60 can include the first junction surface 72 positioned opposite and the second junction surface 74, First junction surface 72 and the second junction surface 74 are arranged at intervals, and axially offset（With respect to central shaft CA）Apart from D1. Particular valve incompetence and other factors that the anatomical structure of the Bicuspid valve 12 according to patient, patient are suffered from, first Can be identical or different apart from D1 between back support member 42 under back support member 42 ' and the second ring under ring ".First junction surface 72 Can have concave shape with each at the second junction surface 74 with respect to the leading section 50 of the support member 40 of general toroidal.Separately Outward, each at the first junction surface 72 and the second junction surface 74 can pass through a completely or only part for structure under at least one lobe Or it is located at the completely or only rear of a part of structure under at least one lobe and extend（Figure 10 B）.

As shown in Figure 11 A- Figure 11 B, back support member 42 under back support member 42 ' and the second ring under the first ring " each Person can alternately have curved annular structure, and this structure includes the hole 134 extending through this structure.Rear portion under first ring The junction surface 60 of each of back support member 42 under support member 42 ' and the second ring " can be with respect to the support member of general toroidal 40 leading section 50 has concave shape.Alternately, back support member under back support member 42 ' and the second ring under the first ring The junction surface 60 of each 42 " is through a completely or only part for structure under at least one lobe or under at least one lobe Structure completely or only a part rear and extend（Figure 11 B）.

As shown in Figure 12 A- Figure 12 C, back support member 42 under back support member 42 ' and the second ring under the first ring " each Person is so structured that and back support member 42 " class under back support member 42 ' under the first ring illustrated by Fig. 7 A- Fig. 7 B and the second ring Seemingly.However, as shown in Figure 12 B, under the first ring, back support member 42 ' is set to extend first apart from D ', and this is first little apart from D ' In with back support member under the second ring 42 " corresponding second distance D ".That is, first is less than second distance D apart from D ' " So that back support member 42 is " axially inclined each other with respect to central shaft CA under back support member 42 ' and the second ring under the first ring Move（Figure 12 A）.

In addition, can see in fig. 12, under the first ring length L1 of back support member 42 ' be set to the second ring under Corresponding length L2 of back support member 42 " overlaps.Back support member 42 under back support member 42 ' and the second ring under first ring " The junction surface 60 of each can have concave shape with respect to the leading section 50 of the support member 40 of general toroidal.In addition, the The junction surface 60 of each of back support member 42 under back support member 42 ' and the second ring under one ring " passes through under at least one lobe Structure completely or only a part or be located at least one lobe under structure completely or only a part rear and extend（Figure 12C）.

Figure 13 A- Figure 13 B illustrates another aspect of the present invention.In addition to described below, the dress shown in Figure 13 A- Figure 13 B Put 10_fWith the device 10 shown in Fig. 7 A- Fig. 7 B_eStructure identical.In Figure 13 A- Figure 13 B, with the structure phase in Fig. 7 A- Fig. 7 B Same structure uses identical reference, and the subsidiary subscript of structure that is similar to the structure in Fig. 7 A- Fig. 7 B but differing “f”.It is understood that device 10_fCan be made up of any materials set forth above, and device 10_fAbove institute can be included The cover layer 68 of the biocompatible materialses stated and/or healing potion（One or more）.

As shown in Figure 13 A- Figure 13 B, device 10_fIncluding front support member 136 under the support member 40 of general toroidal, the first ring And second front support member 138 under ring.The support member 40 of general toroidal can be complete annular, and includes：In first Between portion 44；Second pars intermedia 46；Rearward end 48, this rearward end 48 extends 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 phase To arrangement.Alternately, class annular support member 40 can be part-toroidal, and includes：First pars intermedia 44；Second pars intermedia 46；And rearward end 48, this rearward end 48 extends between the first pars intermedia 44 and the second pars intermedia 46.

Leading section 50（Figure 13 A- Figure 13 B）It is configured to be respectively connecting to the front portion 20 of annulus of mitral valve 18 with rearward end 48 With rear portion 22.For example, rearward end 48, the first pars intermedia 44 and the second pars intermedia 46 form continuous arc, so that after End 48 has 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, so that leading section 50 has convex shape with respect to rearward end 48.As shown in Figure 13 B, substantially ring The support member 40 of shape also includes longitudinal axes L A.The support member 40 of general toroidal can have rigid or semirigid structure.

When device 10_fWhen being implanted on annulus of mitral valve 18 or being implanted to around annulus of mitral valve 18, anterior under the first ring Under support member 136 and the second ring, the size of front support member 138, shape and structure setting are below anterior mitral leaflet 24 And extend, and pass through under at least one lobe structure or be located at the rear of structure under at least one lobe and extend.Under first ring Front support member 136 is attached directly to the support member 40 of general toroidal securely in primary importance 52, and under the second ring before Portion's support member 138 is attached directly to the support member of general toroidal securely in the second position 84 different from primary importance 52 40.For example, as shown in FIG. 13A, under the first ring, front support member 136 is attached directly to the first pars intermedia 44 securely, and Under second ring, front support member 138 is attached directly to the second pars intermedia 46 securely.

As shown in Figure 13 B, under the first ring under front support member 136 and the second ring front support member 138 respectively with angle A 1 With angle A 2 below longitudinal axes L A of the support member 40 of general toroidal extended distance D3 and apart from D4.Anterior under first ring Under the angle A 1 of support member 136 and the second ring, the angle A 2 of front support member 138 makes front support member 136 He under the first ring respectively Under second ring, front support member 138 can promote to optimize leaflet joint.In one embodiment of the invention, anterior under the first ring Under the angle A 1 of support member 136 and the second ring one of angle A 2 of front support member 138 or both can be respectively about Between 20 ° to about 60 °（Such as 30 °）.It is understood that angle A 1 can be identical or different with angle A 2.Similarly, Enable to respective one of front support member 138 under front support member 136 and the second ring under the first ring apart from D3 with apart from D4 Extend in the lower section of anterior mitral leaflet 24 point respectively, so that anterior under front support member 136 and the second ring under the first ring Support member 138 can promote to optimize leaflet joint.It is understood that can be identical or different with apart from D4 apart from D3.

Under front support member 136 and the second ring under first ring, each of front support member 138 is configured to Figure 1A-figure The structure of back support member 42 is similar or identical shown in 1B and under above-described ring.For example, front support member under the first ring The each of 136 and second front support members 138 under ring（Figure 13 A）Include junction surface 140 and integral part of cervical region respectively 142, this cervical region 142 extends to primary importance 52 from junction surface 140.Anterior under front support member 136 and the second ring under first ring The junction surface 140 of each of support member 138 can have arch shape with respect to the leading section 50 of the support member 40 of general toroidal Shape（Such as, convex）.

It is understood that with the device 10 shown in Fig. 7 A- Fig. 7 B_eAnd as the above, device 10_fCan be extraly Or optionally include other features.For example, device 10_fCan include：Governor motion 54；The cover layer of biocompatible materialses 68；It is easy at least one labelling 70 device being connected to annulus of mitral valve 18；And/or a kind of healing potion or multiple curative The combination of agent.

Figure 14 A- Figure 14 C illustrates another aspect of the present invention.In addition to described below, the dress shown in Figure 14 A- Figure 14 C Put 10_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- In Figure 14 C, with Figure 1A-Fig. 1 E and Figure 13 A- Figure 13 B in structure identical structure use identical reference, and with figure Structure in 1A- Fig. 1 E and Figure 13 A- Figure 13 B is similar but the subsidiary subscript " g " of the structure that differs.It is understood that device 10_gCan be made up of any materials set forth above, and device 10_gAbove-described biocompatible materialses can be included Cover layer 68 and/or healing potion（One or more）.

As shown in figure 15, Tricuspid valve 144 is located between right atrium 146 and right ventricle 148.Tricuspid 144 is by Tricuspid valve Leaflet（Hereinafter describe）, tricuspid annulus 150, support chordae tendineae（Typically indicated by 152）And papillary muscless（Typically indicated by 154）. Tricuspid valve 144 is slightly angled relative to vertical direction in itself, the edge of therefore valve be in front upper, the next and in every position, and By these link positions, leaflet is named.Front upper leaflet 156 is maximum leaflet, and is inserted in atrioventricular orifice （Do not show）With arterial cone（Do not show）Between.Rear leaflet 158 is second largest leaflet, and the phase being located according to it Rearward position and concerning is named in the edge of right ventricle 148.3rd little be also minimum in connect every position leaflet 160 To right fibrous trigone and left fibrous trigone（Do not show）And chamber barrier film.Under tricuspid lobe organ include anterior papillary muscless, Rear portion papillary muscless and middle septal papillary muscles 154 and their true chordae tendineae（their true chordae tendineae）152.False Chordae tendineae（False chordae）（Do not show）Two papillary muscless 154 can be connected, connect papillary muscless and ventricle wall or be connected the heart Point on locular wall（points）.True chordae tendineae 152 typically begins with top the 3rd papillary muscless 154, but can also be with middle septal leaflet Leaf 160 equally originates in ventricle wall.

Reference picture 14A- Figure 14 C, device 10_gThe support member 40 of general toroidal can be included_gAnd it is anterior under at least one ring Support member 162, the support member 40 of front support member 162 and general toroidal under ring_gFirmly connect.The support member 40 of general toroidal_gCan To have and tricuspid annulus 150（Figure 15）The corresponding 3D shape of 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_gIncluding leading section 50_g, rearward end 48_g, and positioned opposite In leading section 50_gWith rearward end 48_gBetween extend the first pars intermedia 44_gWith the second pars intermedia 46_g.Leading section 50_gAnd rear end Portion 48_gIt is set to be respectively connecting to the front and rear of tricuspid annulus 150（Figure 15）.Although the support member 40 of general toroidal_g（Figure 14A- Figure 14 C）It is shown as with C-shaped or part annular configuration, but it is understood that, the support member 40 of general toroidal_gPermissible There are other structures, such as complete loop configuration.

As shown in Figure 14 A- Figure 14 C, device 10_gIncluding front support member under ring 162.But it is understood that, device 10_g Can comprise more than front support member 162 under the ring of（Figure 14 D- Figure 14 E）And/or one or more for support in every position The ring lower support element of leaflet 160（Figure 17 A- Figure 17 E）And/or rear tricuspid valve leaflets 158.Under ring, front support member 162 sets Be set to and extend positioned at the lower section of front upper leaflet 156, and pass through at least one lobe under structure completely or only a part or Person is located at the completely or only lower section of a part of structure under at least one lobe and extends.Before under ring as shown in Figure 14 A- Figure 14 C Portion's support member 162 could be arranged to the rear through following structure or positioned at following structure and extends：Front upper Tricuspid valve lobe Whole lower free margins of leaf 156（Do not show）, front upper tricuspid valve leaflets 156 the lower free margins of only a part and front on Position tricuspid valve leaflets 156 correlation chordae tendineae 152 completely or only a part and/or related to front upper tricuspid valve leaflets 156 A completely or only part for papillary muscless 154.

It is understood that the shape of front support member 162, structure and may be sized to through under other lobes under ring Structure or be located at the lower section of structure under other lobes and extend, such as：In every position tricuspid valve leaflets 160 whole lower free margins （Show display）；In every position tricuspid valve leaflets 160 only a part lower free margins；To in related every position tricuspid valve leaflets 160 A completely or only part for chordae tendineae 152；To in every the related papillary muscless of position tricuspid valve leaflets 160 154 completely or only a part； Whole lower free margins of rear tricuspid valve leaflets 158（Do not show）；Under the only a part of rear tricuspid valve leaflets 158 Free margins；The chordae tendineae 152 related to rear tricuspid valve leaflets 158 completely or only a part and/or with rear Tricuspid valve A completely or only part for the papillary muscless 154 of leaflet 158 correlation.

Under ring, front support member 162 can have rigid or semirigid structure.For example, under ring, front support member 162 has When having semirigid structure, under the first ring, front support member can bend or adjust to different positions.Front support member under ring 162 can extraly or preferably include governor motion 54（As mentioned above）, in order to be selectively adjusted front support member under ring 162 with respect to general toroidal support member 40_gLongitudinal axes L A position.

As shown in Figure 14 C, under ring front support member 162 with angle A 3 general toroidal support member 40_fLongitudinal axis Extended distance D5 below LA.Under ring, the angle A 3 of front support member 162 enables to front support member 162 promotion optimization lobe under ring Leaf engages.In one embodiment of the invention, under ring, the angle A 3 of front support member 162 can be about 20 ° to about 40 ° （Such as about 30 °）.Similar, enable to a part for front support member 162 under ring in front upper Tricuspid valve lobe apart from D5 The lower section of leaf 156 extends, to promote to optimize leaflet joint.

Under ring, front support member 162 has structure that is long and narrow, being substantially U-shaped, and includes cervical region 164（Figure 14 A）, should Cervical region 164 is formed with junction surface 166.Cervical region 164 is set in tricuspid valve leaflets 156, tricuspid valve leaflets 158 and tricuspid Extend approx between one of the corresponding joint close position of lobe leaflet 160 or between this joint close position.As Figure 14 A- figure Shown in 14B, cervical region 164 includes first end 168 positioned opposite and the second end 170, and this first end 168 and the second end 170 are respectively Support member 40 with general toroidal_gForm with junction surface 166.For example, the first end 168 of cervical region 164 can with substantially The support member 40 of annular_fThe first pars intermedia 44_gForm.

Under ring, the junction surface 166 of front support member 162 is with respect to the support member 40 of general toroidal_gRearward end 48_gHave Concave shape.Based on implantation, the completely or only part at junction surface 166 is disposed in contact with tying under the whole or lobe of only a part Structure.It is understood that front support member 162 can have Fig. 4 A- Fig. 4 B, Fig. 5-Fig. 6, Figure 14 D- Figure 14 E and figure under ring The combination of one or more of structure shown in 17D- Figure 17 E；Certainly, the junction surface 166 being provided propping up with respect to general toroidal Support member 40_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, including a kind of for treating by the tricuspid 144 that backflows Blood reflux method.Although will be used below the device 10g shown in Figure 14 A- Figure 14 C to describe this Therapeutic Method, should When being understood by, it is possible to use the device including any one or more combination of geometry variation described herein is controlled Treat the blood reflux by the tricuspid 144 that backflows.

As described above, device 10_g（Figure 14 A- Figure 14 C）Support member 40 including part-toroidal_g, this has three dimensional structure The support member 40 of part-toroidal_gIt is provided for connecting to tricuspid annulus 150.Device 10_gAlso include front support member 162 under ring, The support member 40 of front support member 162 and general toroidal under this ring_gThe first pars intermedia 44_fForm.Although in Figure 14 A- Figure 14 C does not show, but it is understood that, the cover layer 68 of biocompatible materialses can be used（Such as suture ring）, at least The combination of one labelling 70 and/or a kind of healing potion or multiple healing potion carrys out cladding system 10_fCompletely or only one Point（Such as, annular support member 40_f）.

Described Therapeutic Method can be according to the method substantially phase with the above-described mitral valve 12 backflowing for treatment Same mode executes.For example, the size that should obtain Tricuspid valve 144 first is to determine device 10_gOptimum size.Lobe can be used The dimensional measurement of Tricuspid valve 144 realized by film measuring appliance, than measuring appliance 86 as described above.Determine tricuspid 144 After size, can to by the blood volume of tricuspid be monitored estimating front upper leaflet 156, rear leaflet 158 with And in every position leaflet 160（As mentioned above）Between joint.Various sizes of measuring piece 90 can be placed on Tricuspid valve 144 Until observing the normal liquor stream substantially by Tricuspid valve 144（Such as, blood or saline）.When observing normal blood substantially When stream is by Tricuspid valve 144, the size selecting of record measuring piece 90 has the size matching with the size of measuring piece 90 Device 10g is in order to implement to implant.It should be appreciated that can additionally or alternatively be passed through to estimate using saline solution test The liquor stream of Tricuspid valve 144 and suitable leaflet engage.

Selecting the suitable device of size 10_gAfterwards, by device 10_gConnect to transmission utensil 114 or above-described On support thing.In order to start implant procedure, can be by silica gel tube（Do not show）Through Tricuspid valve 144 at least one joint close position simultaneously And it is positioned at the rear of structure under at least one lobe, such as related to front upper tricuspid valve leaflets 156 chordae tendineae 152 and/or Individual or multiple papillary muscless 154.When device 10_gWhen being securely connected to transmit utensil 114, stitching thread（Not shown）It is arranged at tricuspid In annulus 150.It is then transported on the top outward appearance that utensil 114 is positioned around Tricuspid valve 144.Then, stitching thread pass through one or Multiple labellings 70（Such as, hole）, transmission utensil 114 joint Tricuspid valve 144 and device 10 simultaneously_gGeneral toroidal support member 40_gIt is pushed to tricuspid annulus 150.

After finishing these, operation silica gel tube is so that the open end of silica gel tube engages front support member 162 under the first ring Far-end.Then silica gel tube never abutting end is lightly extracted out, this will lead to front support member 162 under the first ring to pass through joint close portion Displacement is moved and is engaged with structure under at least one lobe.Then disengage silica gel tube, then remove handle member 88 and strain suture Line, so that device 10_gIt is positioned around Tricuspid valve 144 securely.After completing the tension of stitching thread, cut-out stitching thread is to incite somebody to action Transmission utensil 114 or supporter are from device 10_gUpper separation simultaneously removes from right atrium 14.

Position securely with device 10g（Figure 16 A- Figure 16 B）, the horizontal plane of two heart reconstructions can be produced simultaneously. On ring lower horizontal plane, by moving forward structure under lobe in systole（One or more）, anterior under the first ring Support member 162 supports structure under at least one lobe（Such as, the lower free margins of front upper tricuspid valve leaflets 156 and anterior leaflet phase The chordae tendineae 152 closing and/or the one or more papillary muscless 154 related to anterior leaflet）, this will reduce front tricuspid valve leaflets 24 action is limited and prevents or alleviates the blood reflux by Tricuspid valve 144.In addition, by promoting forward（Or it is mobile）Right The antetheca of ventricle 148 or rear wall can prevent from or alleviate expanding, by ischemic, the Ventricular Remodeling that cardiomyopathy leads to.In addition, in annular On horizontal plane, device 10_gThree-dimensional saddle type geometry also reinvented tricuspid annulus 150 and reduce annular diameter, from And leaflet can be improved and engage.Based on device 10_gSuitable implantation, complete this program and by Tricuspid valve 144 just can recover Often blood flow.

Figure 18 A- Figure 18 C illustrates another aspect of the present invention.In addition to described below, the dress shown in Figure 18 A- Figure 18 C Put 10_hWith the device 10 shown in Figure 14 A- Figure 14 C_gStructure identical.In Figure 18 A- Figure 18 C, with the knot in Figure 14 A- Figure 14 C Structure identical structure uses identical reference, and structure that is similar to the structure in Figure 14 A- Figure 14 C but differing is subsidiary Subscript " h ".It is understood that device 10_hCan be made up of any materials set forth above, and device 10_hCan include with The upper described cover layer 68 of biocompatible materialses and/or healing potion（One or more）.

Device 10_hSupport member 40 including general toroidal_gAnd the support member 40 with this general toroidal_gIt is firmly attached Triplen support member 200 under at least one ring.Annular support member 40 substantially_gCan have and tricuspid annulus 150（Figure 15） The corresponding 3D shape of 3D shape.The support member 40 of general toroidal_gLongitudinal axes L A can be limited（As shown in Figure 14 C）, And the support member 40 of general toroidal_gIncluding leading section 50_g, rearward end 48_g, and positioned opposite in leading section 50_gAnd rear end Portion 48_gBetween extend the first pars intermedia 44_gWith the second pars intermedia 46_g.Leading section 50_gWith rearward end 48_gIt is set to connect respectively Front and rear to tricuspid annulus 150（Figure 15）.Although the support member 40 of general toroidal_gIt is shown as with C-shaped or part The structure of annular, but it is understood that, the support member 40 of general toroidal_gCan have other structures, such as complete annular Structure.

When device 10_hWhen being implanted in tricuspid annulus 150 or being implanted to around tricuspid annulus 150, triplen under ring The size of support member 200, shape and structure setting be positioned at front upper leaflet 156, rear leaflet 158 and in every position leaflet 160 lower sections and extend, and pass through under at least one lobe structure or be located at the rear of structure under at least one lobe and extend.Ring Lower triplen support member 200 is attached directly to the support member 40 of general toroidal securely in primary importance 202_g.For example, such as Shown in Fig. 6 A, under ring, triplen support member 200 is attached directly to the first pars intermedia 44 securely_g.Although not showing, It is understood that triplen support member 200 alternately can be attached directly to the second pars intermedia securely under ring 46_g.

Under ring, triplen support member 200 includes hook-type junction surface 182_h, this hook-type junction surface 182_hBy cervical region 164 1 It is attached directly to the support member 40 of general toroidal body_g.Hook-type junction surface 182_hAlso include the first junction surface 184_h, second connect Conjunction portion 186_hAnd at the first junction surface 184_hWith the second junction surface 186_hBetween extend bending section 188_h.First junction surface 184_h With the second junction surface 186_hEach there is continuous arc（Or arch）Structure, with through structure under at least one lobe or The rear of structure under at least one lobe and extend.First junction surface 184_hWith the second junction surface 186_hCan be with respect to substantially The support member 40 of annular_gLeading section 50_g（Respectively）There is concave shape and convex shape.

First junction surface 184_hAfter being configured to pass through under at least one lobe structure or being located at structure under at least one lobe Just extend, such as：The lower free margins of the bottom outward appearance of rear portion leaflet 158, such as rear portion leaflet 158（Do not show）；With rear portion The chordae tendineae 152 of leaflet 158 correlation；The one or more papillary muscless 154 related to the chordae tendineae of rear portion leaflet 158；And above institute State the combination of part.Additionally, the second junction surface 186_hIt is configured to pass through under at least one lobe structure or be located at least one lobe The rear of lower structure and extend, such as：The bottom outward appearance of front upper leaflet 156, the lower free margins of such as front upper leaflet（Do not show Show）；The chordae tendineae 152 related to front upper leaflet；The one or more papillary muscless 154 related to the chordae tendineae of front upper leaflet；In Every the bottom outward appearance of position leaflet 160, such as in every position leaflet 160 lower free margins（Do not show）；To in related every position leaflet 160 Chordae tendineae；The one or more papillary muscless related to the chordae tendineae of front upper leaflet；And the combination of the above part.At this In a bright embodiment, the second junction surface 186_hBe configured to pass through at least one with front upper leaflet 156 and in every position leaflet 160 is related（Or include）Lobe under structure or be located at least one to front upper leaflet 156 and in related every position leaflet 160 （Or include）Lobe under the rear of structure and extend.

First junction surface 184_hWith the second junction surface 186_hMay be located at identical transverse plane（That is, under longitudinal axes L A The plane extending squarely and parallel or substantially parallel with longitudinal axes L A）, or, alternately, the first junction surface 184_hWith Second junction surface 186_hWith respect to central shaft CA（Figure 18 A- Figure 18 C does not show）It is offset from one another.So, the first junction surface 184_hWith the second junction surface 186_hMay be positioned such that structure under the identical or different corresponding lobe of contact.For example, the first junction surface 184_h With the second junction surface 186_hIt is offset from one another, the first junction surface 184_hIt is configured to pass through the bottom outward appearance of rear portion leaflet 158（Such as, after The lower free margins of portion's leaflet 158）Or be located at the rear of bottom outward appearance of rear portion leaflet 158 and extend, and the second junction surface 186_hBe configured to pass through to front upper leaflet 156 and in every the related chordae tendineae of position leaflet 160 152 or be located at and front upper leaflet 156 and in extend every the rear of the chordae tendineae 152 of position leaflet 160 correlation.

It is understood that as the device 10 shown in Figure 1A-Figure 1B and the above, device 10_dCan be extraly Or optionally include other features.For example, device 10_dCan include：Governor motion 54；The cover layer of biocompatible materialses 68；It is easy at least one labelling 70 device being connected to annulus of mitral valve 18；And/or a kind of healing potion or multiple curative The combination of agent.

By the above description of this invention, it will be appreciated by those skilled in the art that the improvement of the present invention, deformation and modification.This A little improvement, deformation and modification belong to the technical ability scope that this area has one of ordinary skill.

Claims

1. the device by the blood reflux of diseased cardiac valve for a kind for the treatment of, described diseased cardiac valve includes valve annulus, front Structure under portion's valve leaflets, rear portion valve leaflets and lobe, described device includes：

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 extends between described first pars intermedia and described second pars intermedia, and described rearward end is provided for connecting extremely The rear portion of the described valve annulus of described diseased cardiac valve；And

At least one ring lower support element, this ring lower support element is securely connected to the support of described general toroidal in primary importance Part, at least one ring lower support element described is set to positioned at described rear portion valve leaflets and described front portion valve leaflets at least one The lower section of person and extend, and pass through under at least one lobe structure or be located at the rear of structure under at least one lobe and extend；

Wherein, described ring lower support element is configured to and is designed as contacting the lower free margins of described rear portion valve leaflets, thus passively Help prevent or mitigate cardiac valve and backflow.

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

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

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

Integral part of cervical region, this cervical region extends to described primary importance from described junction surface.

4. device according to claim 3, wherein, described junction surface is with respect to described in the support member of described general toroidal Rearward end has convex shape.

5. device according to claim 1, wherein, at least one ring lower support element described has bifurcation structure, this bifurcated Structure includes the first junction surface arranging at intervals and the second junction surface.

6. device according to claim 5, wherein, described first junction surface and described second junction surface are axially inclined each other Move.

7. device according to claim 5, wherein, described first junction surface and described second junction surface are inclined radially from each other Move.

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

9. device according to claim 1, wherein, this device also includes the second ring lower support element, supports under this second ring Part is securely connected to the support member of described general toroidal in described primary importance.

10. device according to claim 1, wherein, at least one ring lower support element described includes governor motion, this regulation Mechanism is used for being selectively adjusted the longitudinal axiss of at least one support member with respect to described general toroidal for the ring lower support element described The position of line.

11. devices according to claim 1, wherein, at least one ring lower support element described has free end.

12. devices according to claim 1, wherein, described ring lower support element partly in described first mid portion and Extend between second mid portion.

13. devices according to claim 1, wherein, described ring lower support element is connected to described annular in single position Support member.

14. devices according to claim 1, wherein, described ring lower support element is through extensibility of structure under partly described lobe.

15. devices according to claim 1, wherein, described ring lower support element passes through the described of described rear portion valve leaflets The part extension of lower free margins.

A kind of devices by the blood reflux of diseased cardiac valve for 16. treatments, described diseased cardiac valve includes valve annulus, front Structure under portion's valve leaflets, rear portion valve leaflets and lobe, described device includes：

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 extends between described first pars intermedia and described second pars intermedia, and described rearward end is provided for connecting extremely The rear portion of the described valve annulus of described diseased cardiac valve；

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

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

Wherein, described first ring lower support element and described second ring lower support element are set to positioned at described rear portion valve leaflets and institute State the lower section of at least one of anterior valve leaflets and pass through structure under at least one lobe and extend or be located at least one The rear of structure under lobe and extend；

17. devices according to claim 16, wherein, described primary importance and the described second position set relative to one another Put.

18. devices according to claim 16, wherein, under a part for described first ring lower support element and described second ring Support member a part of overlapping and axially offseting.

A kind of devices by the blood reflux of diseased cardiac valve for 19. treatments, described diseased cardiac valve includes valve annulus, front Organ under portion's valve leaflets, rear portion valve leaflets and lobe, described device includes：

At least one ring lower support element, this ring lower support element has free end, and is securely connected to described in primary importance The support member of general toroidal, at least one ring lower support element described is set to positioned at described rear portion valve leaflets and described front portion lobe The lower section of at least one of film leaflet and extend, and pass through at least one lobe under structure or be located at least one lobe under structure Rear and extend；

Wherein, each of the support member of described annular and described ring lower support element all have continuous arcuate structure；