CN1829485B

CN1829485B - Method and apparatus for improving mitral valve function

Info

Publication number: CN1829485B
Application number: CN2004800215258A
Authority: CN
Inventors: J·M·罗尔克; J·R·利迪科尔特; D·C·泰勒; W·E·科恩
Original assignee: Viacor Inc
Current assignee: Viacor Inc
Priority date: 2003-05-27
Filing date: 2004-05-26
Publication date: 2012-03-21
Anticipated expiration: 2024-05-26
Also published as: JP4456605B2; WO2004105584A2; CA2526110A1; AU2010200752A1; WO2004105584A3; EP1628599A2; AU2004243029A1; AU2004243029B2; EP1628599A4; CN1829485A; JP2007503287A

Abstract

A method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Description

Be used to improve the method and apparatus of mitral valve function

Quoting of unsettled patent application formerly

Present patent application:

(1) be people such as Daniel C.Taylor in the part continuation application of the 02/05/02 unsettled No.10/068264 of U.S. Patent application formerly (attorney docket No.VIA-29) that is entitled as " method and apparatus that is used to improve mitral valve function " that submits to;

(2) be people such as John Liddicoat in the part continuation application of the 03/29/02 unsettled No.10/112354 of U.S. Patent application formerly (attorney docket No.VIA-19202122) that is entitled as " method and apparatus that is used to improve mitral valve function " that submits to;

(3) be people such as Daniel C.Taylor in the part continuation application of the 08/14/02 unsettled No.10/218649 of U.S. Patent application formerly (attorney docket No.VIA-23) that is entitled as " method and apparatus that is used to improve mitral valve function " that submits to;

(4) be people such as William E.Cohn in the part continuation application of the 10/25/02 unsettled No.10/280401 of U.S. Patent application formerly (attorney docket No.VIA-30) that is entitled as " method and apparatus that is used to improve mitral valve function " that submits to;

(5) be people such as Daniel C.Taylor in the part continuation application of the 01/14/03 unsettled No.10/342034 of U.S. Patent application formerly (attorney docket No.VIA-31) that is entitled as " method and apparatus that is used to reduce mitral incompetence " that submits to; With

(6) require to enjoy the rights and interests of people such as William E.Cohn in 06/26/02 unsettled U.S. Patent application formerly (the attorney docket No.VIA-34 PROV) No.60/391790 that is entitled as " method and apparatus that is used to improve mitral valve function " that submits to.

Above-mentioned six patent applications are incorporated herein by reference.

Invention field

The present invention relates generally to surgical method and device, relates more specifically to be used to improve the surgical method and the device of mitral valve function.

Background of invention

Mitral valve repair is to cure the surgical selection of all pathogenicity mitral incompetences.Utilize current surgical technic, can repair the backflow Bicuspid valve between 70% to 95%.Proved well that at present mitral valve repair has more advantage than Bicuspid valve.These advantages comprise can protect cardiac function better, and minimizing hemorrhage, thromboembolism and the endocarditic risk relevant with anticoagulant.

In current practice, the Bicuspid valve operation need have the processing of invasive, and it comprises incision thoracic wall, cardiopulmonary bypass, cardiopulmonary stop fighting and cut heart itself, so that can touch Bicuspid valve.This operation and high incidence and mortality rate link together.Because the very weak patient of the risk relevant with this operation, many healths can't enjoy the potential benefit that the surgery of mitral incompetence is cured.In addition, can't intervene mitral incompetence patient in early days, and can only just can carry out surgery after developing into to a certain degree and cure in that the sense of heart is bad with moderate symptom.

Mitral incompetence usually occurs on one's body the heart failure patient, and is the major reason of these patients' M & M.The patient of heart failure mitral incompetence taking place on one's body is to be changed by the geometric configuration of left ventricle, papillary muscles and Bicuspid valve ring body to cause.The variation of these geometric configurations causes leaflet of mitral valve when heart contraction, can not engage fully.In this case, only make the annulus of mitral valve body form fold, just can cure mitral incompetence, thereby reduce the circumference of expansion ring body through suture or the combination through suture and support ring, and the original geometry configuration of recovery Bicuspid valve ring body.

More particularly, the surgical practice that is used for mitral valve repair at present usually requires to open left atrium through surgical operation, then with suture or more at large the combination of suture and support ring is fixed on the inner surface of ring body, thereby reduces the radius of Bicuspid valve ring body; This structure is used for the mode that the pocket mouth is sewed up ring body being fastened to less radius, thereby reduces mitral incompetence through the joint that improves lobule.

Mitral this restorative procedure is commonly referred to " annuloplasty ", and it has reduced heart failure patient's mitral incompetence effectively.This has alleviated symptoms of heart failure again, has improved quality of life and has improved the life-span.Yet regrettably, the invasive of Bicuspid valve operation causes most of heart failure patients to have only minority can carry out surgical operation with the risk of being followed.The method that therefore, can improve the lobule zygosity and therefore reduce the still less invasive of the mitral incompetence among the heart failure patient can make this therapy be applicable to most humans.

Mitral incompetence also occurs on one's body about 20% the patient who suffers from acute myocardial infarction.In addition, in the recovery of acute myocardial infarction, about 10% develop among the unsettled patient of serious hemodynamics, mitral incompetence is the main cause of cardiogenic shock.The patient who suffers from mitral incompetence and cardiogenic shock has about 50% hospital mortality.The mitral incompetence of eliminating among these patients is extremely beneficial.Yet regrettably, suffering from serious mitral incompetence and acute myocardial infarction is arranged is high-risk especially surgical operation object as the patient of complication, because of rather than the good surgical object of traditional annuloplasty.Therefore; The temporary non-invasive method that reduces or eliminates that realizes mitral incompetence these extremely sick and weak patients on one's body can be the time that it provides rehabilitation from the disease of myocardial infarction or other serious threat life, and makes it become the surgical object of better medical treatment, intervention therapy or surgical treatment.

Brief summary of the invention

Therefore, an object of the present invention is to provide a kind of method and apparatus that is used to reduce the improvement of mitral incompetence.

Another object of the present invention provides a kind of non-invasive method and apparatus that is used to reduce mitral incompetence.

Another object of the present invention provides a kind of method and apparatus that is used to reduce mitral incompetence, and they can permanently (for example be used for the heart failure patient) or temporarily (for example be used to suffer from the patient of mitral incompetence and acute myocardial infarction) configuration and use.

Can realize these and other purpose through the present invention, it comprises a kind of method and apparatus that is used to reduce the improvement of mitral incompetence.

In a kind of form of the present invention, a kind of method that is used to reduce mitral incompetence is provided, it comprises:

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for making near the intrinsic curvature of at least a portion coronary sinus the lobule of Bicuspid valve rear portion to become straight, so that the rear portion ring body is moved forward, engages thereby improve lobule.

In another form of the present invention, a kind of method that is used to reduce mitral incompetence is provided, it comprises:

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for making near at least a portion coronary sinus the lobule of Bicuspid valve rear portion to move forward, so that the rear portion ring body is moved forward, engages thereby improve lobule.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for reducing near the number of degrees of the intrinsic curvature of at least a portion coronary sinus the lobule of Bicuspid valve rear portion, so that the rear portion ring body is moved forward, engages thereby improve lobule.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for increasing near the intrinsic curvature radius of at least a portion coronary sinus the lobule of Bicuspid valve rear portion, so that the rear portion ring body is moved forward, engages thereby improve lobule.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient; This device has far-end, near-end and mid portion; When this device construction becomes near the coronary sinus device is positioned at mitral rear portion lobule, far-end and near-end will apply active force backward to the wall of coronary sinus, and mid portion will apply active force forward to the wall of coronary sinus; So that the rear portion ring body is moved forward, engage thereby improve lobule.

Roughly straight slender body is inserted near the coronary sinus the lobule of the mitral rear portion of patient; The length of the slender body that this is roughly straight is come sized with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when this roughly straight slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure, so that increase the radius of curvature of Bicuspid valve ring body, engage thereby improve lobule.

Inflexible slender body roughly is inserted near the coronary sinus the lobule of the mitral rear portion of patient; This roughly inflexible slender body is provided with respect near the intrinsic curvature of the coronary sinus the lobule of mitral rear portion; Make when this roughly inflexible slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate various structure, so that the rear portion ring body is moved forward, engage thereby improve lobule.

Straight and roughly inflexible slender body roughly is inserted near the coronary sinus the lobule of the mitral rear portion of patient; This is roughly straight and length roughly inflexible slender body is come sized with respect near the intrinsic curvature of the coronary sinus the lobule of mitral rear portion; Make when this roughly straight and roughly inflexible slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure; So that increase the radius of curvature of Bicuspid valve ring body, engage thereby improve lobule.

In another form of the present invention, a kind of device that is used to reduce mitral incompetence is provided, it comprises:

Body with far-end, near-end and mid portion; When this body configuration becomes near the coronary sinus body is positioned at mitral rear portion lobule; Far-end and near-end will apply active force backward to the wall of coronary sinus; And mid portion will apply active force forward to the wall of coronary sinus, so that move forward mitral rear portion ring body, engage thereby improve lobule.

Roughly straight slender body; It is suitable for being inserted near the coronary sinus of the mitral rear portion of patient lobule; The length of the slender body that this is roughly straight customizes with respect near the intrinsic curvature of the coronary sinus the lobule of mitral rear portion; Make that it will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure when the slender body that this is roughly straight is positioned in the coronary sinus, so that increase the radius of curvature of Bicuspid valve ring body; It is moved forward, engage thereby improve lobule.

Roughly inflexible slender body; It is suitable for being inserted near the coronary sinus of the mitral rear portion of patient lobule; This roughly inflexible slender body is constructed with respect near the intrinsic curvature of the coronary sinus the lobule of mitral rear portion, makes that it will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate various structure when this roughly inflexible slender body is positioned in the coronary sinus; So that the rear portion ring body is moved forward, engage thereby improve lobule.

Roughly straight and roughly inflexible slender body; It is suitable for being inserted near the coronary sinus of the mitral rear portion of patient lobule; This is roughly straight and length roughly inflexible slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of mitral rear portion; Make that it will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure when this roughly straight and roughly inflexible slender body is positioned in the coronary sinus, so that increase the radius of curvature of Bicuspid valve ring body; It is moved forward, engage thereby improve lobule.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for making near the intrinsic curvature of at least a portion coronary sinus the lobule of Bicuspid valve rear portion to become straight, so that the rear portion ring body is moved forward, engages thereby improve lobule;

This device comprises slender body; Before being inserted into slender body in the coronary sinus; It has the degree of curvature littler than the degree of curvature of coronary sinus under unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve, makes the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improves the lobule joint.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for making near at least a portion coronary sinus the lobule of Bicuspid valve rear portion to move forward, so that the rear portion ring body is moved forward, engages thereby improve lobule;

This device comprises slender body; Before being inserted into slender body in the coronary sinus; It has the structure more straight than coronary sinus under unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve, makes the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improves the lobule joint.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for reducing near the intrinsic curvature number of degrees of at least a portion coronary sinus the lobule of Bicuspid valve rear portion, so that the rear portion ring body is moved forward, engages thereby improve lobule; This device is included in has relative slender body than flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Device is inserted near the coronary sinus the lobule of the mitral rear portion of patient, and this device is suitable for increasing near the intrinsic curvature radius of at least a portion coronary sinus the lobule of Bicuspid valve rear portion, so that the rear portion ring body is moved forward, engages thereby improve lobule;

This device is included in has relative slender body than flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Device is inserted near the coronary sinus that is arranged in the lobule of the mitral rear portion of patient; Device has far-end, near-end and mid portion; When this device construction Cheng Dangqi is positioned near the coronary sinus the lobule of Bicuspid valve rear portion, far-end and near-end will apply active force backward to the wall of coronary sinus, and mid portion will apply active force forward to the wall of coronary sinus; So that the rear portion ring body is moved forward, engage thereby improve lobule;

Roughly straight slender body is inserted near the coronary sinus the lobule of patient's Bicuspid valve rear portion; The length of this roughly straight slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when this roughly straight slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure, so that increase the radius of curvature of Bicuspid valve ring body, engage thereby improve lobule;

This roughly straight slender body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Inflexible slender body roughly is inserted near the coronary sinus the lobule of patient's Bicuspid valve rear portion; This roughly inflexible slender body is constructed with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when this roughly inflexible slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate various structure, so that the rear portion ring body is moved forward, engage thereby improve lobule;

This roughly inflexible slender body is included in has relative rod member than flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Straight and roughly inflexible slender body roughly is inserted near the coronary sinus the lobule of the mitral rear portion of patient; This is roughly straight and length roughly inflexible slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when this roughly straight and roughly inflexible slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure; So that increase the radius of curvature of Bicuspid valve ring body, engage thereby improve lobule;

This is roughly straight and roughly inflexible slender body is included in and has the roughly rod member of flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Body with far-end, near-end and mid portion; When this body configuration becomes near the coronary sinus body is positioned at Bicuspid valve rear portion lobule; Far-end and near-end will apply active force backward to the wall of coronary sinus; And mid portion will apply active force forward to the wall of coronary sinus, so that mitral rear portion ring body is moved forward, engage thereby improve lobule;

This body is included in has relative rod member than flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Roughly straight slender body; It is suitable for being inserted near the coronary sinus of patient's Bicuspid valve rear portion lobule; The length of the slender body that this is roughly straight customizes with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make that it will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure when this roughly straight slender body is positioned in the coronary sinus, so that increase the radius of curvature of Bicuspid valve ring body; It is moved forward, engage thereby improve lobule;

This body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of this device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint.

Roughly inflexible slender body; It is suitable for being inserted near the coronary sinus of patient's Bicuspid valve rear portion lobule; This roughly inflexible slender body is constructed with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion, makes that working as this roughly inflexible slender body is positioned in the coronary sinus, and it will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate various structure; So that the rear portion ring body is moved forward, engage thereby improve lobule;

Roughly straight and roughly inflexible slender body; It is suitable for being inserted near the coronary sinus of patient's Bicuspid valve rear portion lobule; This is roughly straight and length roughly inflexible slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make that it will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure, so that the radius of curvature of increase Bicuspid valve ring body when this roughly straight and roughly inflexible slender body is positioned in the coronary sinus; It is moved forward, engage thereby improve lobule;

Device is inserted near the coronary sinus the lobule of patient's Bicuspid valve rear portion; This device is suitable near the intrinsic curvature of at least a portion coronary sinus the lobule of Bicuspid valve rear portion is transformed; So that the rear portion ring body is moved forward; Engage thereby improve lobule, wherein said device comprises rod member and the center rest that links to each other with said rod member.

Slender body; It is suitable for being inserted near the coronary sinus of patient's Bicuspid valve rear portion lobule; This device is suitable near the intrinsic curvature of at least a portion coronary sinus the lobule of Bicuspid valve rear portion is transformed; So that the rear portion ring body is moved forward, engage thereby improve lobule, wherein said device comprises rod member and the center rest that links to each other with said rod member.

Importantly, can be through noninvasive mode embodiment of the present invention permanently or temporarily, so that reduce mitral incompetence.

Brief description

Through the detailed description of the preferred embodiment of the present invention considered below in conjunction with accompanying drawing, more completely open or disclosed these and other purpose of the present invention and characteristic, adopt identical label to represent identical parts in the accompanying drawings, wherein:

Fig. 1 is the sketch map of human blood circulatory system's a part;

Fig. 2 is the sketch map of the part of human heart;

Fig. 3 is the sketch map of the optimum decision system that forms according to the present invention;

Fig. 4-the 7th has shown and has adopted system shown in Figure 3 to reduce a picture group of mitral incompetence;

Fig. 8 has shown a kind of alterative version of delivery conduit;

Fig. 9 has shown a kind of alterative version of flexible push rod;

Figure 10 has shown another alterative version of the present invention;

Figure 11 has shown another alterative version of the present invention;

Figure 12-14 has shown the constructive alternative of the slender body that constitutes a kind of form of the present invention;

Figure 15 has shown the alternative system that forms according to the present invention;

Figure 16 has shown the structure of system shown in Figure 15 during the slender body of configuration using system;

Figure 17-the 19th, the side view of other alternative of slender body;

Figure 20 is the sketch map that acts on the active force on the operation part of assembly of the present invention;

Figure 21 is another alternative sketch map of the present invention;

Figure 22 has shown the sketch map that is configured in the structure shown in Figure 21 in the coronary sinus;

Figure 23 is another alternative sketch map of the present invention;

Figure 24 has shown the sketch map that is configured in the structure shown in Figure 23 in the coronary sinus;

Figure 25 is normal mitral sketch map;

Figure 26 is mitral sketch map that refluxes;

Figure 27 and 28 has shown the sketch map that is inserted into the slender body in the coronary sinus, and wherein this slender body comprises roughly straight and roughly inflexible middle body;

Figure 29 and 30 has shown the sketch map that is inserted into another slender body in the coronary sinus, and wherein this slender body comprises elastic middle body and end portion;

Figure 31 and 32 has shown the sketch map that is inserted into another slender body in the coronary sinus, and wherein to have along its length be variable elasticity to this slender body.

Figure 33 is the sketch map that shows that to be used for two kinds of materials be Nitinol and stainless active force deformation curve;

Figure 34 and 35 is side views of other alternative of slender body;

Figure 36 is the sketch map of another alternative of slender body;

Figure 37 is the schematic side elevation that has shown the slender body shown in Figure 35 that engages with the center rest cooperating type;

Figure 38 is the schematic cross sectional views that is configured in the step in the center rest shown in Figure 37;

Figure 39 is shown as the slender body shown in Figure 37 that is in the coronary sinus and the sketch map of center rest;

Figure 40 is the sketch map of another form of the present invention;

Figure 41 is the cutaway view of the line 41-41 in Figure 40;

Figure 42 is the sketch map of another form of the present invention;

Figure 43 is the cutaway view of the line 43-43 in Figure 42;

Figure 44 is the sketch map of another form of the present invention;

Figure 45 is the cutaway view of the line 44-44 in Figure 44;

Figure 46 is the sketch map that has shown structure shown in the Figure 40-45 that is configured in the coronary sinus;

Figure 47 is the sketch map of another form of the present invention;

Figure 48-51 has shown and has been used for constructive alternative that slender body and center rest are combined;

Figure 52 is the perspective schematic view of the combination of slender body shown in Figure 51 and center rest;

Figure 53 is the perspective view with slender body of the rib that therefrom stretches out;

Figure 54 is the top plan view of slender body shown in Figure 53 and rib assembly;

Figure 55 is the perspective schematic view of another combination of slender body and center rest;

Figure 56 is the perspective illustration of the combination of slender body and center rest, and wherein the structure of center rest comprises a plurality of slender body parts;

Figure 57 is the schematic side elevation of the slender body that is made up of the center rest member fully;

Figure 58 is the schematic side elevation that has shown another combination of the slender body that forms according to the present invention and center rest;

Figure 59 is the schematic side elevation that has shown center rest shown in the Figure 57 that is configured in patient's coronary sinus;

Figure 60 is the schematic side elevation that has shown the combination of slender body shown in the Figure 57 that is configured in patient's coronary sinus and center rest;

Figure 61 is the schematic side elevation that has shown another combination of the slender body that forms according to the present invention and center rest;

Figure 62 is the schematic side elevation that has shown center rest shown in the Figure 60 that is configured in patient's coronary sinus; With

Figure 63 is the schematic side elevation that has shown the combination of slender body shown in the Figure 60 that is configured in patient's coronary sinus and center rest.

Detailed description of preferred embodiment

Coronary sinus is the maximum vein in the human heart.In most of process in it gets into coronary sulcus, coronary sinus extends near about 5 to the 10 cm distance parts the heart left atrium usually.Importantly, a part of length of coronary sinus, for example be about usually a part of 7-9 centimetre roughly extend to the Bicuspid valve ring body the rear portion circumference near.The present invention has utilized this fact.More particularly; Through a kind of novel apparatus being configured near the coronary sinus the lobule of Bicuspid valve rear portion, just can make amendment, so that the rear portion ring body is moved forward near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Engage so that improve lobule, thereby reduce mitral incompetence.

In a preferred embodiment of the invention; This novel apparatus comprises having the roughly slender body of flat construction; When the length of this slender body is made near the coronary sinus slender body is positioned at Bicuspid valve rear portion lobule; Slender body will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate more straight structure, so that the rear portion ring body is moved forward, engage thereby improve lobule.

In a preferred embodiment of the invention, can touch coronary sinus to the percutaneous formula, for example; Can slender body be introduced in the patient's blood vessel system through jugular vein or through left subclavian vein; Be sent to superior vena cava downwards, pass right atrium, get into coronary sinus afterwards and be arranged on the there.Perhaps, can be through small incision on heart or other is cut into the otch in the patient's blood vessel system and slender body is incorporated in the coronary sinus via some.

In a preferred embodiment of the invention; In the following manner slender body is imported to the correct position in the coronary sinus: the conduit that (i) it is passed pre-determined bit; And/or (ii) on the lead of pre-determined bit, transmit slender body, and/or (iii) send it to the surgical site place with the mode (for example on the end that can handle means of delivery) of not having guiding.

In case configure; This new device just can permanently be stayed correct position (for example under the patient's who suffers from the mitral incompetence relevant with heart failure situation), perhaps just temporarily this new device is stayed correct position (for example under the patient's who suffers from the mitral incompetence relevant with acute myocardial infarction situation).

Can wait and realize the visual of operation process through fluoroscopy, ultrasonic cardiography, intravascular ultrasound, blood vessel microscope, nuclear magnetic resonance in real time.Can confirm the curative effect of operation process through ultrasonic cardiography, yet other imaging mode is suitable for also.

Refer now to Fig. 1, it has shown the each side of patient's cardiovascular system 3.More particularly, cardiovascular system 3 comprises heart 6, superior vena cava 9, right subclavian vein 12, left subclavian vein 15, jugular vein 18 and postcava 21 substantially.Superior vena cava 9 is communicated with heart right atrium 24 with postcava 21.Coronary ostium 27 leads to coronary sinus 30.Far-end 31 (Fig. 2) at coronary sinus 30 is located, and vascular structure leads to the anterior interventricular vein (AIV) 32 (referring to Fig. 1 and 2) of vertical decline.For the object of the invention, can think easily that usually term " coronary sinus " refers to the vascular structure that between coronary ostium 27 and AIV 32, extends.

As shown in Figure 2, between coronary ostium 27 and AIV 32, coronary sinus 30 roughly extends near the rear portion circumference of ring body 33 of Bicuspid valve 36.Bicuspid valve 36 comprises rear portion lobule 39 and anterior lobule 42.Produce under the situation about refluxing at Bicuspid valve, rear portion lobule 39 can't correctly engage when heart contraction with anterior lobule 42 usually, thereby stay the intermediate space 45 that allows to take place unfavorable backflow.

Then, shown the system 100 that comprises a preferred embodiment of the invention among the figure referring to Fig. 3.More particularly, system 100 comprises lead 103, delivery conduit 106 and push rod 109 substantially.

Lead 103 comprises the flexible body 112 with far-end 115 and near-end 118.The far-end 115 of lead 103 preferably includes elastic top 121, for example when lead 103 passes the patient's blood vessel system, passes vascular structure the far-end non-invasive of its permission lead 103.

Delivery conduit 106 comprises the flexible body 124 with far-end 127 and near-end 130, and preferably is connected with adjustable valve 133.Center lumen 136 extends to near-end 130 from far-end 127.In some cases retention mechanism can be provided, be used for the far-end 127 of delivery conduit 106 is fixed in the vascular structure.As an example but not restrictive, sense, with expandable air bag 139 be positioned at flexible body 124 outside around, just near far-end 127, and expansion lumen 142 is extended between air bag 139 and expansion pipe 145.

Push rod 109 comprises the flexible body 148 with far-end 151 and near-end 154.On flexible body 148, formed roughly straight and roughly inflexible slender body 157 with various different lengths near far-end 151 parts.Between slender body 157 and near-end 154, be provided with movable near-end bracing boom (or handle) 160, so that promote manually to clamp flexible body 148 to realize advancing or regaining purpose.

System 100 can use to reduce mitral incompetence with being described below.

At first the far-end 115 of lead 103 is passed down through patient's jugular vein 18 (or left subclavian vein 15),, passes the right atrium 24 of heart, extend along coronary sinus 30 afterwards down to superior vena cava 9.Referring to Fig. 4.Should be appreciated that along with flexible wire 103 is sent in the coronary sinus 30 because the flexibility of lead, lead will tend to demonstrate the natural torsion shape of coronary sinus downwards.When handling lead 103 when in place, the elastic top 121 that can not cause wound of lead will help to guarantee that the wound that vascular structure is caused is minimum.

Then the far-end 127 with delivery conduit 106 is positioned on the near-end 118 of lead 103, and transmits downwards along lead, is positioned in the coronary sinus 30 up to the far-end 127 of delivery conduit 106.Referring to Fig. 5.It is also understood that when being delivered in the coronary sinus downwards that because the flexibility of delivery conduit, conduit will tend to demonstrate the natural torsion shape of coronary sinus along with flexible delivery conduit 106.

In case delivery conduit 106 is positioned in the coronary sinus, just removes lead 103.Referring to Fig. 6.Air bag 139 is expanded, so that the far-end 127 of delivery conduit 106 is fixed in the coronary sinus 30.

Then push rod 109 is sent to downwards in the center lumen 136 of delivery conduit 106.When passing the center lumen 136 of delivery conduit 106 along with the roughly straight and roughly inflexible slender body 157 of push rod, this is roughly straight and roughly inflexible slender body 157 will force delivery conduit 106 to demonstrate roughly straight structure (Fig. 7) in straight and roughly inflexible slender body 157 present located positions roughly.Along with push rod 109 promotes downwards along delivery conduit 106, air bag 139 will work, thereby the far-end 127 of delivery conduit 106 is fixed in the coronary sinus 30.

Can utilize proximal handle 160 that push rod 109 is promoted (Fig. 3) downwards along delivery conduit 106 as required, near this roughly straight and roughly inflexible slender body 157 is positioned at the rear portion ring body 33 of Bicuspid valve 36.Referring to Fig. 7.When this thing happens, the existence of the roughly straight and roughly inflexible slender body 157 in the delivery conduit 106 will cause at least a portion coronary sinus 30 to demonstrate roughly straight structure in this, make that the rear portion ring body 33 of Bicuspid valve 36 is pushed forward.This will cause mitral rear portion lobule 39 also to move forward, and engage thereby improve mitral lobule, and therefore reduce (or eliminating fully) mitral incompetence.Should be appreciated that about this point the rear portion ring body can move forward, thereby realize or attempt to reach the degree that lobule-lobule engages or lobule-ring body engages (for example holding onto under the situation of lobule) possible on the anatomy in the left ventricle distortion.Use term " lobule of improvement engages " and/or " enhanced lobule joint " to wait in this article and include these two types joints or target joint.The visual means of use standard (like ultrasonic cardiography and/or fluoroscopy) can be adjusted this definite position roughly straight and roughly inflexible slender body 157, thereby reduce the backflow in (or eliminating fully) Bicuspid valve 36.

It is more smaller than the length of the coronary sinus between coronary ostium 27 and AIV 32 to should be appreciated that in this respect gravel size decision roughly straight and roughly inflexible slender body 157 is processed into.Yet in some cases, need roughly straight and roughly inflexible slender body 157 to be dimensioned to make it extend to outside the coronary sinus 30 and get into right atrium 24.

Further, it is to be appreciated that system provides tactile feedback to a certain degree for the user during disposing.More particularly, be pushed out right atrium 24 and when getting into coronary sinus 30, will run into sizable resistance usually when straight and roughly inflexible slender body 157 roughly; Resistance will move through coronary sinus along with body 157 usually and descend afterwards; And along with the preceding end of the far-end 151 (Fig. 3) of push rod 109 and/or body 157 far-end 31 near coronary sinus, resistance will enlarge markedly usually once more afterwards.Like this; When roughly straight and roughly inflexible slender body 157 is positioned in the coronary sinus between coronary ostium 27 and the AIV 32; Just have some sense of touch " available point ", this sense of touch " available point " help the user will be roughly straight and roughly inflexible slender body 157 correctly be positioned in the coronary sinus 30.

This moment, for example the adjustable valve 133 (Fig. 3) through closure catheter for closing just can lock straight and roughly inflexible slender body 157 roughly, and makes air bag 139 venting in operation process.

System 100 (no lead 103, it is removed) is retained on this position, when it no longer needs till.Under some situation (for example suffering from the patient's of the mitral incompetence relevant with acute myocardial infarction situation), this possibly mean that system 100 will keep several hours, several days or the time in several weeks in this position.Under other situation (for example suffering from the patient's of the mitral incompetence relevant with heart failure situation), system 100 is nonvolatil basically.If removal system 100 then takes out push rod 109 from delivery conduit 106, take out delivery conduit 106 on one's body from patient then.

Therefore can see, utilize the present invention, roughly straight and roughly inflexible slender body 157 roughly enters near the part of common bending of the coronary sinus the lobule of Bicuspid valve rear portion through interference fit.Through will be roughly the length of straight and roughly inflexible slender body 157 carry out correct dimensioned with respect to the intrinsic curvature of differences in patient; And straight and roughly inflexible slender body 157 correctly is positioned in patient's the coronary sinus through inciting somebody to action roughly, and this is roughly straight and roughly inflexible slender body will cause at least a portion coronary sinus near the rear portion of Bicuspid valve 36 lobule 39, to demonstrate roughly straight structure.This effect can make mitral rear portion ring body move forward again, engages thereby improve lobule, and therefore reduces mitral incompetence.Therefore, through will be roughly straight and roughly inflexible slender body 157 be inserted near the coronary sinus 30 the rear portion lobule 39 of Bicuspid valve 36, can mitral ring body 33 effectively be operated, make it demonstrate the radius curve of increase.

As stated; Through will be roughly the length of straight and roughly inflexible slender body 157 carry out correct dimensioned with respect to the intrinsic curvature of differences in patient; And straight and roughly inflexible slender body 157 correctly is positioned in patient's the coronary sinus through inciting somebody to action roughly; This is roughly straight and roughly inflexible slender body 157 will cause at least a portion coronary sinus near the rear portion of Bicuspid valve 36 lobule 39, to demonstrate roughly straight structure; Drive mitral rear portion ring body thus and move forward, engage thereby improve lobule, and therefore reduce mitral incompetence.For this reason; Push rod 109 preferably provides as the part of tool set, and this tool set has a plurality of different push rods 109, and each push rod is corresponding to the slender body 157 of different size; Like this, the doctor can be the particular patient anatomical structure and selects and be provided with the suitable slender body of size 157.In addition, need the slender body 157 of different size if when being provided with, find (for example through ultrasonic cardiography and/or fluoroscopy), so available second push rod 109 with slender body 157 of required size is replaced first push rod 109.

In a kind of preferred form of the present invention, the appropriate length for the slender body 157 of confirming to be applicable to the particular patient anatomical structure at the very start can at first be inserted into diagnosis in patient's the coronary sinus with push rod 109; Equally, in order to confirm the preferred size of slender body 157, can the diagnosis of a series of different sizes sequentially be inserted in patient's the coronary sinus with push rod 109.Afterwards, can the treatment of suitable dimension be inserted in the coronary sinus with push rod 109, engage, thereby reduce mitral incompetence so that improve lobule.

In addition, in will diagnosing the coronary sinus that is inserted into patient with push rod 109 before, the doctor can carry out entry evaluation to the size of coronary sinus, thereby confirms the initial estimation length of diagnosis with the slender body 157 of push rod 109.This can in fluoroscopy, utilize lead 103 with radiopaque sign, or through use have the radiopaque sign delivery conduit 106, or another device (like flexible member) that will have a radiopaque sign is inserted in the coronary sinus, or the alternate manner that utilizes those of skill in the art and known accomplish.Utilize the radiopaque sign, the doctor can carry out entry evaluation to the size of coronary sinus, so that confirm the initial estimation length of diagnosis with the slender body 157 of push rod 109; The exchange diagnosis is with push rod 109 as required afterwards, and till the appropriate length of confirming slender body 157, push rod is used in the diagnosis that replace this suitable dimension with treatment with push rod 109 this moment.

Also find, through will be roughly straight and roughly inflexible slender body 157 be inserted near the coronary sinus the lobule of mitral rear portion, can also reinvent (remodeling) patient's left ventricle, thereby help to alleviate congestive heart failure.

Especially be noted that; According to the present invention; This is roughly straight and the far-end of roughly inflexible slender body 157 and near-end can apply backward active force (for example among Fig. 7 shown in the arrow P) on the wall of coronary sinus 30, and this pars intermedia branch roughly straight and roughly inflexible slender body 157 applies forward active force (for example among Fig. 7 shown in the arrow A) on the wall of coronary sinus 30.

In some cases, standard patient care method capable of using such as adhesive tape, pocket mouth stitching thread, skin staple etc. are fixed on the near-end 130 (Fig. 3) of delivery conduit 106 on patient's the crust.In other cases, the near-end 130 of delivery conduit 106 can comprise the suture cover, thereby can be through sewing up the tissue that delivery conduit is fixed on patient.For example, shown among the figure that suture cover 166 is connected on the near-end 130 of delivery conduit 106 referring to Fig. 8.If necessary, element 169 can be provided near adjustable valve 133, so that make flexible push rod 109 under the condition of not using adjustable valve 133 (Fig. 3), be sent to delivery conduit 106 fast.As an example, element 169 comprises and can flexible push rod 109 be fixed on the curled element on the delivery conduit 106, for example utilizes suture cover 166 can delivery conduit 106 be fixed on one's body the patient.If necessary, for example under permanent implanted situation, can the near-end of assembly be embedded under patient's the skin.

As stated, before being pushed into push rod 109 in the delivery conduit, it is helpful that the far-end of delivery conduit 106 is anchored in the coronary sinus.When straight and roughly inflexible slender body 157 roughly overturns in right atrium and gets in the coronary sinus, this set will make delivery conduit remain on correct position.When not carrying out this anchoring, push rod possibly order about under the delivery conduit and slide in the postcava 21.More particularly; When straight and roughly inflexible slender body 157 roughly runs into initial resistance and in coronary sinus, overturns; Be fixed on through far-end on the wall of coronary sinus 30, just can make conduit settle out and can not redirect in the postcava 21 delivery conduit 106.Air bag 139 is a kind of modes that realize this anchoring.Yet, can also utilize retention mechanism such as the alligator clamp of other type, rib to wait far-end 127 to be anchored at the correct position in the coronary sinus 30 with delivery conduit 106.

If desired, the far-end 151 of push rod 109 itself can be provided with terminal anchor, terminal anchor 172 for example shown in Figure 9.This terminal anchor on the push rod 109 helps straight and roughly inflexible slender body 157 is roughly remained on the appropriate position in the coronary sinus 30.

Under the condition on the wall that far-end of delivery conduit 106 is not anchored at coronary sinus, can prevent that also delivery conduit 106 from forwarding in the postcava 21 downwards.More particularly, referring now to Figure 10, shown a kind of supporting tube 173 that forms by flexible body 124 firmer materials among the figure than delivery conduit 106.Supporting tube 173 is configured to when push rod 109 is passed down through delivery conduit 106; Its far-end 174 is positioned in the coronary ostium 27; Afterwards its sidewall 174A can with delivery conduit 106 be supported on postcava 21 near forward to downwards in the postcava 21 so that prevent delivery conduit 106.Figure 10 has also shown the insertion conduit 174B of the porch that is positioned at jugular vein 18.

In the system of discussing in the above 100; Push rod 109 is described as and can be advanced to the surgical site place through delivery conduit 106, and the orthopaedic surgical operations surgical site is retained in the delivery conduit 106, and in the time will taking out push rod 109; Can take out push rod 109 earlier, take out delivery conduit 106 then.Yet if necessary, in case push rod 109 is configured in the surgical site place, just can take out delivery conduit 106, the orthopaedic surgical operations operative site only stays push rod 109.For example referring to Figure 11.

Also can push rod 109 directly be advanced to surgical site, and needn't transmit through conduit; In this case, push rod 109 can advance through vascular structure between the chamber voluntarily, in the time of in being configured in coronary sinus 30 till.

As stated, in the time of near the zone push rod 109 is advanced to mitral rear portion ring body, roughly straight and roughly inflexible slender body 157 will make the inherent structure distortion of coronary sinus, make it demonstrate roughly straight structure.Though can bringing out required Bicuspid valve, this effect reinvents; But it also maybe be on the wall of coronary sinus, especially cause great stress in roughly far-end and proximal end straight and roughly inflexible slender body 157, will produce stress concentration (referring to the arrow P among Fig. 7) in these places., can make amendment by structure roughly straight to this and roughly inflexible slender body 157 for this reason, these stress can be distributed better.

More particularly, next referring to Figure 12, roughly straight and the far-end of roughly inflexible slender body 157 and the part 175 that near-end comprises relative flexibility, its stress that helps to be applied on the wall of coronary sinus distributes better.As additional and/or alternative, the far-end and any cone on the near-end that are applied to roughly straight and roughly inflexible slender body 157 can be elongated, shown in the label among Figure 13 178, thereby the stress that is applied are distributed on the wall of coronary sinus better.In a kind of preferred form of the present invention, referring now to Figure 14, this is roughly straight and roughly inflexible slender body 157 comprises the relative part 175 than long and relative flexibility with relative slender cones 178.If necessary, each relatively long and part 175 relative flexibility that comprises relative slender cones 178 can be the same long, perhaps more longer with the roughly straight and roughly inflexible mid portion of slender body 157.

Follow Figure 15, shown the system 181 that comprises another preferred embodiment of the present invention among the figure.More particularly, system 181 generally includes lead 103, roughly straight and roughly inflexible slender body 184 and pushing sleeve pipe 187.

Lead 103 is as indicated above.

The roughly straight and roughly inflexible slender body 184 that provides with various different lengths comprises far-end 188 and near-end 190.Center lumen 193 is extended between far-end 188 and near-end 190.Center lumen 193 can be held lead 103.

Pushing sleeve pipe 187 comprises far-end 194 and near-end 196.Center lumen 199 is extended between far-end 194 and near-end 196.Center lumen 199 can be held lead 103.

System 181 uses so that reduce mitral incompetence in the following manner.

At first the far-end 115 of lead 103 is passed patient's jugular vein 18 (or left subclavian vein 15),, pass the right atrium 24 of heart, and extend along coronary sinus 30 down to superior vena cava 9.Should be appreciated that when flexible wire 103 passes coronary sinus 30 because the flexibility of lead, lead will trend towards demonstrating the natural torsion shape of coronary sinus.When the non-invasive elastic top 121 of lead will help to reduce to greatest extent to advance to appropriate position along with lead to damage that vascular structure caused.

Next roughly far-end 188 straight and roughly inflexible slender body 184 is positioned on the near-end 118 of lead 103, and transmits one section downwards than short distance along lead.The far-end 194 that will push sleeve pipe 187 then is positioned on the near-end 118 of lead 103, advances pushing sleeve pipe 187 downwards along lead afterwards.Along with pushing sleeve pipe 187 advances along lead, its far-end 194 is pushed the roughly straight and roughly inflexible slender body 184 that is positioned at its place ahead.Referring to Figure 16.

Along with will be roughly straight and roughly inflexible slender body 184 be passed in the coronary sinus, it will force coronary sinus to demonstrate roughly straight structure in straight and roughly inflexible slender body 184 present located positions roughly.Can promote to push sleeve pipe 187 downwards along lead as required, in the time of near roughly straight and roughly inflexible slender body 184 is positioned mitral rear portion ring body till.When this happens, this is roughly straight and the existence of roughly inflexible slender body 184 in coronary sinus will cause coronary sinus to demonstrate roughly straight structure at this some place, thereby makes mitral rear portion ring body receive compressing forward.This will cause mitral rear portion lobule also to move forward, and engage thereby improve lobule, and therefore reduce (or eliminating fully) mitral incompetence.Utilize the visual means of standard (like ultrasonic cardiography and/or fluoroscopy) can adjust this definite position roughly straight and roughly inflexible slender body, thereby reduce the backflow in (or eliminating fully) Bicuspid valve.

If necessary, pushing sleeve pipe 187 can be provided with releasable connecting interface (for example grasper), thereby it is fixed near-end 190 straight and roughly inflexible slender body 184 roughly releasedly.This characteristic will allow for the purpose of locating or taking out this roughly straight and roughly inflexible slender body to be withdrawn in the coronary sinus.

Therefore can see that according to the present invention, roughly straight and roughly inflexible slender body 184 enters near the part of common bending of the coronary sinus the lobule of Bicuspid valve rear portion through interference fit basically.Come correctly to process length roughly straight and roughly inflexible slender body 184 through intrinsic curvature with respect to differences in patient; And through will be roughly straight and roughly inflexible slender body 184 correctly be positioned in patient's the coronary sinus, this roughly straight and roughly inflexible slender body 184 just will cause at least a portion coronary sinus near the rear portion of Bicuspid valve 36 lobule 39, to demonstrate roughly straight structure.This effect makes mitral rear portion ring body move forward again, engages thereby improve lobule, and therefore reduces mitral incompetence.Like this, through will be roughly straight and roughly inflexible slender body 184 be inserted near the coronary sinus 30 the rear portion lobule 39 of Bicuspid valve 36, can mitral ring body 33 effectively be operated, make it demonstrate the radius curve of increase.

As stated; Come correctly to process length roughly straight and roughly inflexible slender body 184 through intrinsic curvature with respect to differences in patient; And straight and roughly inflexible slender body 184 correctly is positioned in patient's the coronary sinus through inciting somebody to action roughly; This roughly straight and roughly inflexible slender body 184 just will cause at least a portion coronary sinus near the rear portion of Bicuspid valve 36 lobule 39, to demonstrate roughly straight structure; This can order about mitral rear portion ring body again and move forward, and engages thereby improve lobule, and therefore reduces mitral incompetence.For this reason; This is roughly straight and roughly inflexible slender body 184 preferably provides as the part of tool set; This tool set comprises a plurality of different roughly straight and roughly inflexible slender bodies 184; They all have the slender body 184 of different size, and like this, the doctor can be the particular patient anatomical structure and selects and the suitable slender body 184 of configuration sized.In addition; If find that when configuration (for example through ultrasonic cardiography and/or fluoroscopy) needs the slender body 184 of different size; So available second slender body 184 with required size is replaced first slender body 184, thereby reaches required therapeutic effect.

In a kind of preferred form of the present invention, the appropriate length for the slender body 184 of just confirming to be applicable to the particular patient anatomical structure at the beginning can at first be inserted into diagnosis slender body 184 in patient's the coronary sinus; Equally, in order to confirm the preferred size of treatment slender body 184, can the diagnosis slender body of a series of different sizes sequentially be inserted in patient's the coronary sinus.Afterwards, can the treatment of suitable dimension be inserted in the coronary sinus with slender body 184, engage, thereby reduce mitral incompetence so that improve lobule.

In addition, in will diagnosing the coronary sinus that is inserted into patient with slender body 184 before, the doctor can carry out entry evaluation to the size of coronary sinus, thereby confirms the initial estimation length of diagnosis with slender body 184.This can in fluoroscopy, utilize lead 103 with radiopaque sign, or another device (like flexible member) that will have a radiopaque sign is inserted in the coronary sinus, or the alternate manner that utilizes those of skill in the art and known accomplish.Utilize radiopaque sign, the doctor can carry out entry evaluation to the size of coronary sinus, so that confirm the initial estimation length of diagnosis with slender body 184; Afterwards as required exchange diagnosis with slender body 184, till confirming the appropriate length of diagnosis with slender body 184, use this moment treat replace this suitable dimension with slender body 184 diagnosis with slender body 184.

Equally as stated; In the time of near this roughly straight and roughly inflexible slender body 184 is advanced to Bicuspid valve rear portion ring body the zone; This is roughly straight and roughly inflexible slender body 184 will make the inherent structure of coronary sinus be out of shape, and makes it demonstrate roughly straight structure.Though can bringing out required Bicuspid valve, this effect reinvents; But it also maybe be on the wall of coronary sinus, especially cause great stress in roughly far-end and proximal end straight and roughly inflexible slender body 184, will produce stress concentration (referring to the arrow P among Fig. 7) in these places., can make amendment by structure roughly straight to this and roughly inflexible slender body 184 for this reason, these stress can be distributed better.

More particularly, next referring to Figure 17, roughly straight and the far-end of roughly inflexible slender body 184 and the part 188A that near-end can comprise relative flexibility, 190A, its stress that helps to be applied on the wall of coronary sinus distributes better.As additional and/or alternative; The far-end and any cone on the near-end that are applied to roughly straight and roughly inflexible slender body 184 can be elongated; Like the label 188B among Figure 18, shown in the 190B, thereby the stress that is applied is distributed on the wall of coronary sinus better.In a kind of preferred form of the present invention, referring now to Figure 19, this is roughly straight and roughly inflexible slender body 184 comprises having relative slender cones 188B, the part 188A of the relatively long and relative flexibility of 190B, 190A.If necessary, each comprises relative slender cones 188B, the part 188A of the relatively long and relative flexibility of 190B, and 190A can be the same long, perhaps more longer with the roughly straight and roughly inflexible mid portion of slender body 184.

In the discussion formerly, it is roughly straight and roughly inflexible that slender body 157 (or 184) is described as usually, has or do not have part 175 (Figure 12) (or the 188A of relative flexibility; 190A, Figure 17) and/or cone 178 (Figure 13) (or 188B, 190B; Figure 18) and/or conical section 175,178 (Figure 14) (188A, the 188B of relative flexibility of elongation; 190A, 190B, Figure 19).Yet should be appreciated that term " roughly straight ", " roughly rigidity ", " relative flexibility " etc. should understand in relating to the context of anatomical tissue, do not understand and be taken on the absolute sense.

Taking it by and large; Slender body 157 (or 184) is configured such that (1) intermediate portion has applied active force forward (for example shown in the arrow A among Fig. 7) on the wall of coronary sinus, and (2) its far-end and near-end have applied active force backward (for example shown in the arrow P among Fig. 7) on the wall of coronary sinus.On the contrary; On the mid portion of slender body 157 (or 184), applied higher centre-line load L1 (Figure 20) through the Bicuspid valve ring body, and the rear portion of coronary sinus applies less end load L2 (Figure 20) on the far-end of slender body 157 (or 184) and near-end.

Through using slender body 157 (or 184) especially can produce this influence; Wherein, (1) with the rear portion lobule of Bicuspid valve ring body near the intrinsic curvature of coronary sinus part compare; Slender body 157 (or 184) is more straight (but needn't be straight fully), and (2) are compared with the anatomical tissue that is moved by the slender body that is disposed 157 (or 184), and slender body 157 (or 184) has more rigidity (but needn't be perfect rigidity).

As stated, be distributed on the proximal part of coronary sinus part 175 (Figure 12) (or the 188A that the far-end of slender body 157 (or 184) and near-end have relative flexibility better in order to make load; 190A, Figure 17) and/or cone 178 (Figure 13) (or 188B, 190B; Figure 18) and/or conical section 175,178 (Figure 14) (188A, the 188B of elongated relative flexibility; 190A, 190B, Figure 19).In addition, these parts 175 (188A, 190A), 178 (188B, 190B) and/or 175,178 (188A, 188B, 190A, flexibility 190B) can change along its length; Thereby, the conical section 175,178 (Figure 14) of elongated relative flexibility (188A, 188B, 190A, 190B Figure 19) has more flexibility along with it becomes towards its outer end extension.

Really, in the present invention and do not require that the mid portion of slender body 157 (or 184) is an absolute rigidity; In fact, as long as it has certain resistance to the higher centre-line load L1 (Figure 20) that the Bicuspid valve ring body is applied basically, can play gratifying effect.Far-end and near-end through making slender body 157 (or 184) form less resistance to the less end load L2 (Figure 20) that rear wall guided by coronary sinus, also can further improve design.Like this; Utilize a kind of device that has a rigidity gradient along its length just can realize gratifying design; Wherein the highest rigidity is positioned at or near the center, and relatively low stiffness is positioned at or (perhaps opposite, this device has the flexible gradient along its length near its two ends; Wherein minimum flexibility is positioned at or near the center, and higher flexibility is positioned at or near its two ends).This can be tapered through making slender body; And/or through changing its composition and/or material properties; And/or through those of skill in the art according to the disclosure and clearly other technology realize.Perhaps, a kind of device that has flexibility to a certain degree along its whole length capable of using is realized gratifying design; This flexibility can change along with length, and perhaps the whole length along slender body 157 (or 184) all is constant.

Therefore, as stated, utilize slender body 157 (or 184) can realize gratifying design; Wherein, (1) with the rear portion lobule of Bicuspid valve ring body near the intrinsic curvature of coronary sinus part compare, slender body 157 (or 184) is more straight (but needn't be straight fully), and; (2) compare with the anatomical tissue that is moved by the slender body that is disposed 157 (or 184), slender body 157 (or 184) has more rigidity (but needn't be perfect rigidity).

In other alternative embodiment, slender body 157,184 can be made up of two or more roughly straight and roughly inflexible part R, and these are roughly straight and roughly inflexible part R is linked together by one or more flexible portion F.For example referring to Figure 21 and 22, it has shown this structure.Through the relative length of change part R and F, and, can realize that just good ring body moves, thereby reduce mitral incompetence better through changing roughly rigid element R relative rigidity and the relative flexibility that changes flexible portion F.

Figure 23 and 24 has shown another kind of preferable configuration, and wherein roughly straight and roughly inflexible slender body 157,184 comprises a plurality of part S ₁, S ₂And S ₃, part S wherein ₁Be constructed with the flexibility of selected degree, part S ₂Be constructed with than part S ₁The flexibility of low degree more, and part S ₃Be constructed with than part S ₁The flexibility of higher degree.Part S ₁, S ₂And S ₃Can be integrally formed each other, perhaps link together through joint.Since this structure, part S ₁With the load of carrying reconstruct Bicuspid valve ring body, part S ₂This load is transferred to part S laterally ₃, and part S ₃This load is diffused into laterally on the sidewall of coronary sinus.In a kind of preferred form of the present invention, part S ₁Be constructed with flexibility to a certain degree, this flexibility can support reinventing of Bicuspid valve ring body, allows part S simultaneously ₁Roughly conform to the curvature camber line of Bicuspid valve ring body at junction point; Part S ₂Be constructed with the flexibility of enough low degrees, make that all will be passed to part S by the load that reinventing of Bicuspid valve ring body causes basically ₃On; And part S ₂Has sufficiently long length, so that the active force backward (for example shown in the arrow P among Fig. 7) on the wall that acts on coronary sinus is applied on the near-end and far-end of valve commissures basically.In this way, pure stretching effect produces outside pressure, and it makes the fibrous continuous part tensioning of heart substrate, but not this therein active force can cause tensioning between the valve commissures of backflow.Wherein, this being configured to define to making in the zone around the lobule of rear portion centering naturally, and conform to naturally with the curvature of rear portion lobule.If necessary, the slender body of this " five region-types " can be formed by a kind of material, wherein utilizes different diameters to form different body regions.

Therefore can see that in various alternatives, slender body 157 and/or 184 is flexible along the one of which partial-length at least.Zonal flexibility and zonal rigidity can make the selected location of coronary sinus become straight, and corresponding to the position of rear portion Bicuspid valve ring body.This can cause the zone of Bicuspid valve ring body to move forward, thereby in lobule engages, forms regional the improvement.In addition; Slender body can be formed by two ends that filament links together: through coming these two ends of anchoring with respect to anatomical structure and straining filament; Can the wall straightening of the natural torsion of coronary sinus so that rear portion Bicuspid valve ring body is moved forward, thereby be reduced mitral incompetence.

Through changing the rigidity of slender body 157,184, can bring the variation on the anatomical structure of certain limit to Bicuspid valve.More particularly, Figure 25 has shown the normal Bicuspid valve 36 that

lobule

39,42 fully engages, and Figure 26 Bicuspid valve 36 that refluxes that shown generation that

lobule

39,42 does not fully engage.

At slender body 157; 184 middle body has more absolute rigidity more greatly and obviously for anatomical structure; And slender body 157; 184 two ends end under the situation of part (the for example structure shown in Figure 14 and 19) of relative flexibility, the moving basically shown in Figure 27 and 28 of anatomical structure.

Has heart S therein at slender body 157,184 ₁With its two ends S ₃The place have certain flexibility and in the coupling part S ₂Locate under the situation of inflexible comparatively speaking rod member (the for example structure shown in Figure 23 and 24), can be made into and to be provided for supporting ring body and to form the slight flexible suspender belt that engages, for example shown in Figure 29 and 30 with the wall of coronary sinus.In a kind of preferred form of the present invention; Slender body 157; 184 have along the flexibility of its length customization, it can closely be conformed to, so that rear portion ring body (and rear portion lobule) is moved towards anterior lobule with the geometry of natural ring body; Keep the rear portion ring body to be under its intrinsic curvature simultaneously, shown in Figure 31 and 32.

In a kind of preferable configuration, slender body 157,184 has the geometry and the flexibility of customization, makes on the position of active force backward on the wall act on coronary sinus (for example among Fig. 7 shown in the arrow P) with far-end that is mainly used in forward and backward Colaesce respectively and near-end.For example referring to Figure 30 and 32; How structure was applied to its active force on patient's the anatomical structure shown in it had shown; Be that mid portion applies active force (shown in arrow A) forward on the wall of coronary sinus, and far-end and near-end apply active force (shown in arrow P) backward on the wall of coronary sinus.Active force P is applied in the zone of valve commissures through inciting somebody to action backward, and the side that just can reduce to greatest extent in the Colaesce zone sprays, and the good lobule of obtained performance engages.

In addition to the foregoing, should be appreciated that the active force total amount that acts on the Bicuspid valve ring body be slender body 157,184 size and geometry with and flexible function.In a kind of preferred form of the present invention; Slender body 157; 184 size, geometry and elasticity preferably make has higher active force (active force of 2-5 pound according to appointment) to be applied on the middle body of Bicuspid valve ring body; When being inserted into slender body 157,184 in the coronary sinus, will realize at once basically that usually Bicuspid valve is reinvented completely thus.In another preferred form of the present invention; Slender body 157; 184 size, geometry and elasticity preferably make has obvious littler active force (pressure of 1-3 pound according to appointment) to be applied on the Bicuspid valve ring body; Thus when be inserted into slender body 157,184 in the coronary sinus, usually will be only at once the Bicuspid valve of implementation part reinvent; Yet; Through forming slender body 157 by enough flexibilities or preferred hyperelastic material such as Nitinol; 184; Even under the situation that anatomical structure begins in response to load to move, slender body also will lastingly afterwards apply the Bicuspid valve ring body and reinvent active force, thereby realize required reinventing fully gradually so.

Form by elastomeric material and under required Bicuspid valve reinvented the latter event of progressively realizing in time, the active force that often slender body 157,184 is applied kept constant relatively in time at slender body 157,184.For this reason, some material may be better than other material.More particularly, next referring to Figure 33, it has shown the sketch map that to be used for two kinds of materials be Nitinol and stainless active force deformation curve.Shown in figure 33, when Nitinol when deforming then during tissue remodeling subsequently relaxation during initial the implantation, it has applied constant relatively active force to tissue; Yet when rustless steel was out of shape then relaxation, it had applied the active force that alters a great deal to tissue.Therefore, slender body 157,184 needs to be formed by Nitinol or other hyperelastic material at least in part usually.

Except that aforementioned, it is the shape of non-straight along its length that slender body 157 and/or 184 can have various.For example, slender body can be waveform, spiral type or along it whole or partial-length is crooked shape.As an example, slender body 157 and/or 184 can have a kind of warp architecture that can change the intrinsic curvature of coronary sinus, that is, make it crooked towards anterior ring body.Perhaps, slender body has the compound shape along its length, and for example, it can have a kind of " w " shape, and wherein anterior ring body is pointed at the center of " w ".Any of these or other alternative shape all can realize moving forward of rear portion ring body, and this has just caused the minimizing of mitral incompetence.

Next referring to Figure 34-36, can see that slender body 157 and/or 184 is provided with the circumferential rib 200 (Figure 34 and 35) that extends radially outwardly from slender body 157,184.Rib 200 engages with the wall of delivery conduit 106, perhaps engages with the wall of coronary sinus 30 not using delivery conduit 106 or taken out under the situation of delivery conduit 106, so that alleviate slender body 157,184 displacement in time.Rib 200 is also limited by the annular groove in the slender body 157,184 202 (Figure 36), and in this case, the circumferential surface 204 of rib 200 overlaps with body circumferential surface 205.Rib 200 is provided with the periphery 207 (Figure 35) of roughly straight periphery 206 (Figure 34 and 36) or somewhat frusto-conical structure.Under latter event, preferably the inclined-plane 208 at the edge 207 of some rib 200 is towards proximal direction, and the inclined-plane 208 of all the other ribs is towards distal direction (Figure 35).Comprise flexible portion 175 (Figure 12) (or 188A, 190A at slender body 157,184; Figure 17) and/or cone 178 (Figure 13) or (188B, 190B, Figure 18) and/or the conical section 175 of elongated relative flexibility; 178 (Figure 14) (or 188A, 188B, 190A; 190B under situation Figure 19), also can form rib 200 on these structures.

Shown that in Figure 37 slender body 157,184 shown in combination Figure 34 uses together the alternative of center rest 210.In this embodiment, center rest 210 comprises the substantial cylindrical roof beam structure that is placed in the coronary sinus that engages with it, and is anchored at securely on the wall of coronary sinus, afterwards slender body 157,184 (with the rib 200 on it) is placed in the center rest 210.The rib 200 of slender body 157,184 engages with the some parts of center rest 210, makes slender body be anchored at securely on the correct position in the coronary sinus 30.For example, comprise under the situation that is in the perforate between its Vierendeel girder that rib 200 can interact with Vierendeel girder and perforate, so that help slender body 157,184 is locked on the center rest 210 at center rest 210.

More particularly; Utilize this form of the present invention, can center rest 210 be anchored on the wall of coronary sinus securely (for example through outwards expanding, and/or through being penetrated into the tissue in the bracket holes; And/or through the entrained barb of support etc.); And slender body 157,184 (with the rib 200 on it) is anchored at (for example engaging through rib-support) on the center rest 210 securely, thereby (1) helps elongate body 157; 184 in order to avoid vertically move; So that provide maintainable mitral incompetence to reduce, and/or the some place that (2) help to act on coronary sinus at maximum load L1 (Figure 20) supports coronary sinus 30, and/or (3) help slender body 157; 184 concentrated end load L2 (Figure 20) is distributed on the big zone of coronary sinus; So that reduce damage that host blood vessel is caused to greatest extent, and/or (4) help to limit the metamorphosis that the blood vessel section takes place in response to acting on the load on the blood vessel inner face, so that guarantee reliable blood flow and reduce blood vessel injury to greatest extent.Should be appreciated that in this respect coronary sinus takes on a different character (for example, the robustness of diameter, wall etc.) along its length usually, and can correspondingly center rest 210 is designed to demonstrate different character along himself length.As a nonrestrictive example, center rest 210 can be had and had less diameter at its far-end and have bigger diameter in its proximal end, so that corresponding to the typical geometry of coronary sinus.As another nonrestrictive example, can center rest 210 be designed to near-end (vein is always softer relatively) at coronary sinus here and locate the support that provides bigger, and locate to provide less support here at the far-end (vein is always firmer relatively) of coronary sinus.

In of the present invention a kind of form in slender body 157 is placed on the center rest 210 in the coronary sinus 30, as indicated above, at first lead 103 is advanced in the coronary sinus.The support configuration that will have center rest 210 is advanced in the coronary sinus along lead 103 with conduit 212 (Figure 38).When center rest 210 is in the desired location in the coronary sinus; The buffer 214 that bridges on lead 103 engages with center rest; And the support configuration is withdrawn into the degree that is enough to dispose center rest 210 with conduit 212; Remove with buffer 214 afterwards, stay center rest 210 and be on the correct position in the coronary sinus 30 with lead 103.Transmit delivery conduits 106 along lead 103 then, till the far-end of conduit is in coronary sinus and center rest.In case delivery conduit 106 is positioned in coronary sinus and the center rest, just can removes lead 103.Transmit push rod 109 via the center lumen 136 of delivery conduit 106 then, be positioned near the rear portion ring body of Bicuspid valve 36 up to slender body 157 and till being arranged in center rest 210.Recall delivery conduit 106 then, make the rib 200 of body engage with center rest, as stated, push rod 109 stays in place, and slender body 157 is locked in the center rest 210.

Slender body 184 is placed in another form of the present invention in the center rest 210 in the coronary sinus therein, lead 103 is pushed in the coronary sinus as indicated abovely.The support configuration that has center rest 210 within it is installed on the lead 103 with conduit 212, and is advanced in the coronary sinus 30.Utilize buffer 214 that center rest 210 is remained on correct position afterwards; And support configuration is withdrawn into the degree that is enough to dispose center rest 210 with conduit 212; Afterwards it is recalled with buffer 214 in the lump, and lead 103 and center rest 210 are stayed correct position.On lead 103, promote body 184 and pushing sleeve pipe 187 then, till slender body 184 is arranged in the center rest 210.To push sleeve pipe 187 afterwards and recall in the lump, and slender body 184 and center rest 210 will be stayed correct position, and slender body 184 will be locked in the center rest with lead 103.

Referring to Figure 39, can see that the maximum load (L1) that acts on slender body 157,184 and the center rest 210 is positioned at the office, intermediate portion, this has just reduced the displacement of center rest, and has therefore reduced the displacement of body 157,184 to far-end or near-end.

Next referring to Figure 40 and 41, can also see that slender body 157,184 can have than the obvious littler diameter of the diameter of center rest 210.In this case, center rest 210 can be provided with the guide rail 211 that is used to accept slender body 157,184.As an example, guide rail 211 comprises the hollow pipe that is formed on center rest 210 inwalls, and the size of guide rail 211 is suitable for accepting slender body 157,184, and it is fixed with respect to center rest 210.If necessary, center rest 210 can be shorter than the end of slender body 157,184 and stop, and Figure 40 for example is shown in 41.As alternative, center rest 210 stops with the terminal of slender body 157,184 synchronously, and for example with mode shown in Figure 42 and 43, perhaps, center rest 210 may extend into outside the end of slender body 157,184, for example with the mode shown in Figure 44 and 45.

At a kind of use Figure 40,41 or Figure 42,43 or Figure 44; 45 center rest 210 and slender body 157; In 184 the method for optimizing, at first utilize the support configuration to dispose center rest 210 with conduit 212 and buffer 214, this is similar with Figure 38; Difference is lead 103 is modified as eccentric, so that extend through the guide rail 211 of center rest with mode shown in Figure 46.Center rest 210 is configured at first in the above described manner, and uses lead 103 that slender body 157,184 is encased in the correct position in the coronary sinus, comprises the guide rail 211 that passes center rest.

Referring now to Figure 47,, in another structure, when center rest is encased in support configuration with conduit 212 in the time, can slender body 157,184 be pre-loaded in the guide rail 211 of center rest; Utilize this structure, can in coronary sinus, dispose center rest 210 and slender body 157,184 simultaneously.

Shown in figure 48, slender body 157,184 can be configured as the part of center rest 210; The center rest of this combination partly is positioned at slender body 157; 184 pars intermedia office, here coronary sinus has applied maximum load L 1, and it is the load because of the mobile coronary sinus of treatment.Equally, center rest 210 can be shorter than slender body 157,184 ends and stop (Figure 48); Perhaps center rest 210 can with slender body 157; 184 ends synchronously stop (Figure 49), and perhaps center rest 210 extends to outside the end of slender body 157,184 (Figure 50).

In another embodiment shown in Figure 51 and 52; Slender body 157; 184 comprise two or more holder part with the combination of center rest 210, for

example part

210A and 210B, and wherein part 210A is arranged on the mid portion of this combination; And part 210B extends through part 210A and from its end, stretch, and defines to have bigger elastic end portion.Body 157,184 is fixed on the substantial cylindrical holder part 210A in the mid portion that is positioned at body 157,184, and is fixed on the semi-cylindrical support end portion 210B.Mid portion 210A is the firmest part in the combination of slender body and center rest, and it is that part that is used for carrying maximum load L1.

In Figure 53 and 54, show an alternative, wherein on slender body 157,184, be fixed with the rib 215 of one group of two capable rib form.Shown in Figure 54, the row of rib 215 preferably departs from each other, make be positioned on slender body 157,184 one sides rib not with the slender body opposite side on rib relative.This can make rib 215 can not close with relative ribbed joint towards the opposite side bending.The bending of rib allows rib to be compressed and to be arranged in the conduit.

In Figure 55, shown a constructive alternative similar with Figure 54, however its demonstrate rib 215 and link to each other with ridges 216, this ridges 216 is a hollow, so that accept slender body 157,184 therein.

The alternative combinations that in Figure 56, has shown slender body and carriage assembly, wherein center rest 210 comprises that form is the slender body part 157,184 of the rod member that integrates with support.In the embodiment shown in Figure 56, at least one body part 157,184 extends to the other end from an end of assembly, and 157,184 mid portions that extend to assembly of another body part.Therefore, the end portion of assembly is poorer than the rigidity of intermediate portion.

Can see referring to Figure 57; Body 157; 184 include only center rest; Center rest 210 ＇ that are provided with of telescopically for example; 210 ＂ and 210

; Like this; Mid portion comprise all three center rests 210 '; 210 ＂ and 210

; The part that just is positioned at the mid portion outside comprise center rest 210 ＂ and 210

, and end portion includes only center rest 210

.Therefore, the mid portion of body 157,184 is maximum to the repellence that moves, and the repellence of end portion is minimum, and the zone of center rest 210 ＂ produces than mid portion resistance still less, but its resistance is greater than end portion.

Next referring to Figure 58-60, shown the alternative combinations of slender body and carriage assembly among the figure, wherein slender body comprises five region-type slender bodies 157 shown in Figure 23 and 24; 184; And support comprises three supporting brackets, and each is all shown in Figure 40-47, promptly; Has the guide rail 211 that is used to accept slender body 157,184.More particularly, this five region-types slender body 157,184 comprises a plurality of part S ₁, S ₂And S ₃, part S wherein ₁Be constructed with the flexibility of selected degree, part S ₂Be constructed with than part S ₁The flexibility of low degree more, and part S ₃Be constructed with than part S ₁The flexibility of higher degree.Since this structure, part S ₁With the load of carrying reconstruct Bicuspid valve ring body, part S ₂This load is transferred to part S laterally ₃, and part S ₃This load is diffused into laterally on the sidewall of coronary sinus.In a kind of preferred form of the present invention, part S ₁Be constructed with flexibility to a certain degree, this flexibility can support reinventing of Bicuspid valve ring body, allows part S simultaneously ₁Roughly conform to the curvature camber line of Bicuspid valve ring body at junction point; Part S ₂Be constructed with the flexibility of enough low degrees, make that all will be passed to part S by the load that reinventing of Bicuspid valve ring body causes basically ₃On; And part S ₂The active force backward (for example shown in the arrow P among Fig. 7) on the wall that acts on coronary sinus has sufficiently long length, so that will be applied in the zone of valve commissures.Supporting bracket 210 is positioned in the coronary sinus 30, makes a support 210 hold part S ₁, a support 210 has held a part S ₂, also have a support 210 to hold another part S ₃Slender body 157,184 can be configured with supporting bracket 210 simultaneously, perhaps after having disposed supporting bracket 210, is configured.Part S ₃Preferably can on support guide 211, slide, especially work as slender body 157,184 and be designed in the long term, progressively realize under the situation of tissue remodeling.Wherein, this structure is configured as and can makes in himself zone around the lobule of rear portion centering naturally, and conforms to well with the curvature of rear portion lobule.If necessary, the slender body of this " five region-types " can be formed by a kind of material, wherein utilizes different diameters to form different body regions.

It is also understood that support 210 has the extended position structure, or have the rib-like structure shown in Figure 53 and 54.

Then referring to Figure 61-63; Shown the combination of a kind of slender body and carriage assembly among the figure, it is similar to shown in Figure 58-60, and difference is; Guide rail 211 extends between each stent area, thereby forms the single supporting structure with three zones that engage with the wall of coronary sinus.

Like this, can provide different center rest structure to produce displacement to prevent this roughly straight and roughly inflexible slender body, the combination that various bodies and center rest also can be provided is to prevent or to alleviate this displacement similarly.

Should be appreciated that the present invention never is limited to these concrete structures disclosed herein and/or that illustrate in the drawings, but comprise all remodeling or equivalent constructions in the claim scope.

Claims

1. device that is used to reduce mitral incompetence comprises:

Body with far-end, near-end and mid portion; When said body configuration becomes near the coronary sinus said body is positioned at mitral rear portion lobule; Said far-end and near-end apply active force backward to the wall of coronary sinus; And said mid portion applies active force forward to the wall of coronary sinus, so that said mitral rear portion ring body is moved forward, engages thereby improve lobule;

Said body is included in the rod member that has flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint;

Said body comprises a central area, two zone lines and two perimeters; Wherein, Said two zone lines lay respectively between a said central area and said two perimeters; Said central area is constructed with the flexibility of selected degree, and said zone line is constructed with than the said central area flexibility of low degree more, and said perimeter is constructed with the flexibility than said central area higher degree.

2. device according to claim 1 is characterized in that said device also comprises the center rest that links to each other with said rod member.

3. device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the roughly straight slender body near the coronary sinus of the mitral rear portion of patient lobule; The length of said roughly straight slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when said roughly straight slender body is positioned in the coronary sinus; It will cause at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure; So that increase the radius of curvature of Bicuspid valve ring body, it is moved forward, engage thereby improve lobule;

Said body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body will be moved forward, and improve the lobule joint;

4. device according to claim 3; It is characterized in that; Said roughly straight slender body is roughly straight before in being inserted into patient, and after in being inserted into patient because of and anatomical structure between passive type elastic interaction but general curved.

5. device according to claim 3 is characterized in that said device comprises the center rest that is connected on the said rod member.

6. device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the roughly inflexible slender body near the coronary sinus of the mitral rear portion of patient lobule; Said roughly inflexible slender body is constructed with respect near the intrinsic curvature of the coronary sinus the lobule of Bicuspid valve rear portion; Make when said roughly inflexible slender body is positioned in the coronary sinus; It causes at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate various structure, so that the rear portion ring body is moved forward, engages thereby improve lobule;

Said body is included in has the roughly rod member of flat construction under the unstress state; And the rigidity of said device is higher than the anatomical tissue that is between device and the Bicuspid valve; Make the layout of said device in coronary sinus that the rear portion ring body is moved forward, and improve the lobule joint;

7. device according to claim 6 is characterized in that the rigidity of said roughly inflexible slender body is higher than the anatomical tissue that is between device and the Bicuspid valve, but still is flexible.

8. device according to claim 6 is characterized in that said device comprises the center rest that is connected on the said rod member.

9. device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the roughly straight and roughly inflexible slender body near the coronary sinus of the mitral rear portion of patient lobule; Said length roughly straight and roughly inflexible slender body customizes with respect near the intrinsic curvature of the coronary sinus the lobule of said Bicuspid valve rear portion; Make when said roughly straight and roughly inflexible slender body is positioned in the coronary sinus; It causes at least a portion coronary sinus near the lobule of mitral rear portion, to demonstrate roughly straight structure; So that increase the radius of curvature of Bicuspid valve ring body, it is moved forward, engage thereby improve lobule;

10. device according to claim 9 is characterized in that, said slender body is roughly straight in being inserted into patient before, and is general curved after in being inserted into patient.

11. device according to claim 9 is characterized in that, the rigidity of said roughly inflexible slender body is higher than the anatomical structure that is between device and the Bicuspid valve, but still is flexible.

12. device according to claim 9 is characterized in that, said device comprises the center rest that is connected on the said rod member.

13. device according to claim 9; It is characterized in that; Said device also comprises and is suitable for being positioned at the delivery conduit in patient's coronary sinus; Said delivery conduit is formed by flexible material, makes its structure that will roughly demonstrate coronary sinus, and said delivery conduit is suitable for accepting therein said straight and roughly inflexible slender body.

14. device according to claim 13; It is characterized in that; Said straight and roughly inflexible slender body is installed on the rod member; Said rod member is formed by flexible material, make said rod member will demonstrate the structure of coronary sinus, and the size of said rod member is adapted to be mounted within the said delivery conduit.

15. device according to claim 13 is characterized in that, said device also comprises the lead removed that is used for said delivery conduit is positioned at coronary sinus.

16. device according to claim 9; It is characterized in that; Said device also comprises the lead that is suitable for being positioned in the coronary sinus, and said lead is formed by flexible material, makes it will roughly demonstrate the structure of coronary sinus; And said straight and roughly inflexible slender body is a hollow, so that be enclosed within on the said lead.

17. device according to claim 9; It is characterized in that; Said far-end straight and roughly inflexible slender body and at least one in the near-end comprise flexible portion, are used for when said straight and roughly inflexible slender body is arranged on coronary sinus, alleviating the stress that is applied on the coronary sinus.

18. device according to claim 9; It is characterized in that; Said far-end straight and roughly inflexible slender body and in the near-end at least one are tapered, are used for when said straight and roughly inflexible slender body is arranged on coronary sinus, alleviating the stress that is applied on the coronary sinus.

19. device according to claim 9 is characterized in that, said straight and roughly inflexible slender body has the length that is no more than the coronary sinus part that is between coronary ostium and the AIV.

20. device according to claim 13 is characterized in that, said device also comprises supporting tube, is used for when said straight and roughly inflexible slender body passes said delivery conduit, preventing that said delivery conduit from redirecting to postcava.

21. a device that is used to reduce mitral incompetence comprises:

Be suitable for being inserted into the slender body near the coronary sinus of patient's Bicuspid valve rear portion lobule; Said device is suitable for transforming near the intrinsic curvature of at least a portion coronary sinus of Bicuspid valve rear portion lobule; So that said rear portion ring body is moved forward; Engage thereby improve lobule, wherein said device is included in rod member that has flat construction under the unstress state and the center rest that links to each other with said rod member;