CN101184455A - Devices, systems, and methods for reshaping a heart valve annulus - Google Patents
Devices, systems, and methods for reshaping a heart valve annulus Download PDFInfo
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- CN101184455A CN101184455A CNA2006800183909A CN200680018390A CN101184455A CN 101184455 A CN101184455 A CN 101184455A CN A2006800183909 A CNA2006800183909 A CN A2006800183909A CN 200680018390 A CN200680018390 A CN 200680018390A CN 101184455 A CN101184455 A CN 101184455A
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Abstract
Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.
Description
Technical field
For example the present invention relates in the treatment mitral incompetence, to be used to improve equipment, system and the method for cardiac valve function.
Background technology
I. healthy heart anatomy
Heart (referring to Fig. 1) is slightly larger than holds tight fist.Heart is bilateral (left side and right side) self-interacting type muscle pump, and a plurality of part collaborative works of heart are to be pushed to blood all parts of body.The right side of heart receives anoxia (" venous ") blood and it is passed pulmonary artery from body by superior vena cava and postcava and is pumped to lung to carry out Oxygenation.The left side is passed pulmonary vein and is rich in oxygen (" tremulous pulse ") blood from the lung reception, and it is pumped to aorta to be used to be distributed to body.
Heart has four chambers, two of every sides--right atrium and left atrium, and right ventricle and left ventricle.The atrium is the chamber that receives blood, and it is delivered to blood pump in the ventricle.Ventricle is the chamber of discharging blood.The wall (being called the interatrial septum) that is made of fiber and muscle parts separates right atrium and left atrium (referring to Fig. 2 to Fig. 4).Compare with more brittle muscular tissue in the heart, the fiber interatrial septum to a certain degree is more blocky organizational structure in the heart in essence.The anatomic landmark of interatrial septum is to be called avette lacuna, or the depression (as Fig. 4 and shown in Figure 6) of avette, the thumbnail size of fossa ovalis, and fossa ovalis is the traces of oval foramen and is valve when fetus.Described fossa ovalis does not have any important structure such as valve structure, blood vessel and pathway.In conjunction with the inherent fibre structure of fossa ovalis and can make that it passes through that the angiography technology discerns around the fiber protuberance, fossa ovalis is the ideal position of wearing from right side heart to the left side heart every diagnosis and treatment procedure.In utero, pass oval foramen from the Oxygenated blood of Placenta Hominis and enter left atrium, and after birth the oval foramen closure.
The synchronous pump action on left side of heart and right side constitutes cardiac cycle.The described cycle is with the beginning in period (being called ventricular diastole) of ventricular diastole.Finish the period (being called Ventricular systole) of described cycle with ventricular systole.
Heart has four valves (referring to Fig. 2 and Fig. 3), and described valve can guarantee that blood can not flow along the direction of mistake during cardiac cycle; Guarantee that promptly blood can not be back to the corresponding atrium from ventricle, or be back to the corresponding ventricle from tremulous pulse.Valve between left atrium and left ventricle is a Bicuspid valve.Valve between right atrium and the right ventricle is a Tricuspid valve.Valve of pulmonary trunk is at Pulmonic opening part.Aortic valve is at aortal opening part.
When ventricular diastole (that is, ventricular filling) begins (referring to Fig. 2), aortic valve and valve of pulmonary trunk closure are back in the ventricle to prevent driven arteries and veins.Soon afterwards, Tricuspid valve and Bicuspid valve are opened (as shown in Figure 2), flow to the corresponding ventricle from the atrium with permission.Soon, Tricuspid valve and Bicuspid valve closure (referring to Fig. 3) are back to the corresponding atrium from ventricle preventing after paradoxical expansion (ventricle emptying) beginning, and aortic valve and valve of pulmonary trunk open, and are expelled to the tremulous pulse from the ventricle of correspondence to allow blood.
Valvular open and closed mainly owing to pressure differential realizes.For example, mitrally open and closed realize by the pressure differential between left atrium and the left ventricle.During ventricular diastole, when the ventricle diastole, be back to venous return blood the left atrium from pulmonary vein and make pressure in the atrium greater than the pressure in the ventricle.Therefore, Bicuspid valve is opened, thereby allows blood to enter ventricle.When ventricle shrank during Ventricular systole, intraventricular pressure raise and greater than the pressure in the atrium, and promotes MC.
Bicuspid valve and Tricuspid valve are limited by collagen fiber ring-type thing (being called as ring respectively), and described ring forms the part fibrous framework of heart.Described ring is provided for mitral two lobe points or lobe leaf (lobe point and posterior cusp before being called) and tricuspid three lobe points or lobe leaf is attached.Described lobe leaf is from receiving the chordae tendineae chordae tendineae more than a papillary muscles.In healthy heart, these muscle and chordae tendineae thereof support Bicuspid valve and Tricuspid valve, thus the high pressure that allows the opposing of lobe leaf during left ventricle and right ventricle contraction (pumping), to produce.Fig. 5 and Fig. 6 show and support mitral tendon element and papillary muscles in left ventriclies.
As shown in Figures 2 and 3, the non-coronary valve leaf of aortic valve is pressed close to by preceding (A) portion of annulus of mitral valve.Equally as shown in Figures 2 and 3, annulus of mitral valve also near other crucial cardiac structure, as the circumflex branch of left coronary artery (as described in left coronary artery circumflex branch supply left atrium, variable left ventricle and in many people supply sinuatrial node also) and atrioventricular node (as described in atrioventricular node regulate cardiac cycle) with sinuatrial node.
Coronary sinus and branch thereof are also near the rear portion of annulus of mitral valve (P).These vasculars are discharged the blood by the heart area of left coronary artery supply.Coronary sinus and branch thereof receive roughly 85% Coronary vein blood.Coronary sinus empties to the rear portion of right atrium, front portion and bottom (referring to Fig. 4) of fossa ovalis with blood.The branch of coronary sinus is called as great cardiac vein, it is parallel to the annulus of mitral valve operation of most back, and be higher than back annulus of mitral valve (Yamanouchi, Y, Pacing and Clinical Electophysiology 21 (11): 2522-6 with the average distance of about 9.64+/-3.15 millimeter; 1998).
II. the feature of Bicuspid valve malfunction and reason
After left ventricle is being full of from the blood of left atrium and when shrinking, ventricle wall moves inward and with some release of tension from papillary muscles and tendon.The blood that the lower surface of relative mitral leaflet upwards promotes makes mitral leaflet rise towards mitral anchor ring.When mitral leaflet when going in ring into, the leading edge of preceding lobe leaf and posterior valve leaflet is poly-to forming sealing and closed valve together.In healthy heart, the joint of lobe leaf be formed on annulus of mitral valve planar near.Blood is pressurization continuously in left ventricle, injects in the aorta up to it.Ventricular systole and the valve lobe leaf that is used to keep fit were closely closed when the peak systolic pressure that is applied by ventricle when papillary muscles shrank.
In healthy heart (referring to Fig. 7 and Fig. 8), the size of annulus of mitral valve forms anatomic shape and tension force, thereby the lobe leaf engages when peak systolic pressure, connects and form closely.The lobe leaf is called as the lobe leaf in the position that opposed inside (CM) and the outside (CL) of ring engage and unites the place.
Owing to chordae tendineae (tendon) is stretched and tears the dysfunction that produces valve when some situation.When pulled tendon, the result makes the lobe leaf be the flail shape.And the valve of normal configuration can be because increase in the valve annulus or deformation and can not suitably play a role.This state is called as the expansion of ring and normally produces owing to myocardial failure.And valve can be at birth or owing to defective appears in acquired disease.
Which kind of reason (referring to Fig. 9) no matter, when the lobe leaf can not engage during at peak systolic pressure, malfunction will appear in Bicuspid valve.As shown in Figure 9, the closing line of two lobe leaves is not tight at Ventricular systole.Therefore, desirably be back in the left atrium from the blood of left ventricle is non-.
Mitral incompetence is to allow blood to flow to state the left atrium backward from left ventricle at the period two cusp that left ventricle is shunk.This state has two main consequences.
The first, be back to blood in the atrium and can cause higher atrial pressure and reduce flowing to blood flow the left atrium from lung.When blood was retracted in the lung system, escape of liquid caused pulmonary edema to lung.
The second, the blood volume in whereabouts atrium has reduced to advance to the blood volume in the aorta, and cardiac output is reduced.Blood excessive in the atrium makes the ventricle over filling in each cardiac cycle, and makes the blood volume over loading of left ventricle.
Mitral incompetence is measured with the numerical grade scope of 1+ to 4+ by the contrast ventriculography or by doppler ultrasound estimation method.Grade 1+ be the trace backflow and have less clinical meaning.Grade 2+ represents to be back to the injection adverse current in the left ventricle midway.Backflow grade 3 expression left atriums fill upward to pulmonary venous adverse current and three times or the contrast injection that still less empties in the heartbeat of number of times.The backflow class 4 have oppositely to the pulmonary vein adverse current and three times or the contrast injection that still less can not empty from the atrium in the heartbeat of number of times.
Mitral incompetence is divided into two kinds of main types, and is (i) organic or structural, and (ii) functional.Organic mitral incompetence is owing to valve parts unusual on the structure produce, and unusual valve parts leak valve lobe leaf on the described structure in systole.Functional mitral regurgitation is that similar no thanks to serious irreversible ischemia or the cardiopathic reason of constitutional valve cause that the expansion of ring forms owing to the Primary Congestive DHF, and wherein said Primary Congestive DHF itself can not pass through surgical operation therapy usually.
Owing to tendon or papillary muscles are torn when making the lobe leaf be the flail shape to make seal break-off, organic mitral incompetence can appear in the free leading edge of lobe leaf; If or lobe leaf texture is too much, valve can form the higher height that engages in the atrium sagging, and ventricular systole interim further sagging with in the atrium more the highland open valve.
Functional mitral regurgitation is owing to the expansion of the heart that is secondary to heart failure and annulus of mitral valve produces, and more produces owing to coronary artery disease or idiopathic dilatation cardiomyopathy.Unsound ring among ring healthy among Fig. 7 and Fig. 9 is compared, unsound ring extension, and particularly increase along the distance of minor axis (line P-A) from the front portion to the rear portion.Therefore, by the shape that limits of ring and tension force can not become oval (referring to Fig. 7) and more circular (referring to Fig. 9).This state is called expansion.When ring extension, the shape and the tension force that help to engage when peak systolic pressure constantly destroy.
The fiber annulus of mitral valve its 1/3rd circumferentially in be attached to anterior mitral cusp.The muscle annulus of mitral valve constitutes remaining annulus of mitral valve and attached by Bicuspid valve back lobe leaf.Preceding fiber annulus of mitral valve is pressed close to central fibrous body, and the two ends of described central fibrous body are called as fibrous triangle.The just rearward of each fibrous triangle is that the preceding inboard (CM) and the outside, back (CL) two unite the place.The described place of associating is the position of preceding lobe leaf in ring place junction posterior valve leaflet.
As mentioned above, central fibrous body is also pressed close to the non-coronary valve leaf of aortic valve.Central fibrous body carries out certain opposing to elongation during the annulus of mitral valve expansion.What illustrated is that most annulus of mitral valve expansions appear in back 2/3rds (that is the muscle ring) of ring.Can derive thus, when ring extension, the percentage rate relevant with anterior mitral cusp reduces.
In functional mitral regurgitation, the ring of expansion makes the lobe leaf separate at its abutment in all stages of cardiac cycle.In organic or functional mitral regurgitation, the morbidity of mitral incompetence can be acute, or gradual and chronic.
In being derived from ischemic or idiopathic DCM (dilated cardiomyopathy), annulus of mitral valve can be extended to the degree that causes functional mitral regurgitation.About 25 percent have the patient of congestive heart failure this problem can occur in the resting state evaluation.If at the volley, the ultrasoundcardiogram sickness rate that is presented at functional mitral regurgitation among these patients rises to and surpasses 50 percent.
Functional mitral regurgitation is serious apparently problem for the dilatancy heart, compares with the comparable patient who does not have functional mitral regurgitation to reflect that mortality rate increases.The mechanism that functional mitral regurgitation increases the weight of these patients' situation is the increase by the volume over loading of forcing at ventricle.Direct because leak, heart needs to make the blood direct motion to pass aortic valve in each cardiac cycle and the work of passing the Bicuspid valve ejaculation of driving in the wrong direction increases.The latter is called as the regurgitation fraction of left ventricle ejaculation amount.Regurgitation fraction adds to the forward direction ejection fraction to produce total ejection fraction.Normal heart has and is about 50% to 70% forward direction ejection fraction.And functional mitral regurgitation and DCM (dilated cardiomyopathy), total ejection fraction is typically less than 30 percent.If regurgitation fraction is half of total ejection fraction in the DCM (dilated cardiomyopathy) group, then the forward direction ejection fraction can be low to moderate 1 15.
III. prior treatment method
In the treatment of mitral incompetence, diuretic and/or vasodilation can be used to help to reduce the blood volume that is back in the left atrium.If state can not be stable by medicine, then can use the anti-equipment of fighting of endaortic sacculus.For chronic or acute mitral incompetence, usually need to undergo surgery to repair or to replace Bicuspid valve.
Nowadays, patient's choice criteria of Bicuspid valve operation is very selectively.Patient's choice criteria of feasible Bicuspid valve operation comprises: normal ventricular function, substantially good health status, greater than the predicted lifes in 3 to 5 years, NYHA symptom grouping III or IV and the grade 3 that refluxes at least.Carry out mitral valve repair if desired, the not serious young patient of symptom is suitable for carrying out early operation.The most common Bicuspid valve surgical repair program is to be used for because the tendon torn and the organic mitral incompetence that produces in the shellfish portion of posterior valve leaflet.
In the annuloplasty ring-type thing of routine was repaired, back annulus of mitral valve was made the stitching that ring set carries out and circumferentially is reduced along it by passing through annuloplasty.The purpose of this reparation be make Bicuspid valve back lobe leaf forward the lobe leaf move ahead and engage better allowing.
The edge-to-edge who equally also carries out carrying out in blood vessel performs the operation to engage and repairs, and wherein middle part valve lobe leaf to the stitching or the clamping of middle part valve lobe leaf is used to make these abutments of lobe leaf to keep together in whole cardiac cycle.Other trial has developed stitching and the clamping carried out and has reached in conjunction with two mitral leaflets to firmly grasp in the heart of beating in blood vessel.
The organic mitral incompetence of grade 3+ or 4+ can be repaired by this edge-to-edge's technology.This is because in organic mitral incompetence, and problem does not lie in ring and is the valve parts at middle part.
Yet even after the edge-to-edge repairs, functional mitral regurgitation still can maintain higher grade, particularly when the situation of the functional mitral regurgitation of higher level 3+ and 4+.After the operation, the valve of reparation can develop into the functional mitral regurgitation of higher probability in time.
In the technology that another kind occurs, coronary sinus acts on by institute and mechanically be out of shape with method in the blood vessel that only plays a role in coronary sinus comprise.
It is reported among 6,000,000 Americans that 25 percent the patient with congestive heart failure has functional mitral regurgitation to a certain degree.Thereby constitute 1,500,000 patients with functional mitral regurgitation.Wherein, the idiopathic dilatation cardiomyopathy has 600,000 people.All the other have 900,000 philtrums of ischemic diseases, and roughly half is only owing to the dilatancy ring has functional mitral regurgitation.
By the cycle of the functional mitral regurgitation of interrupting carrying out, the survival rate that demonstrates the patient who undergos surgery improves and the forward direction ejection fraction of most of patients in fact increases.The problem of operative treatment is it to the significant injury that these long sexually transmitted disease (STD)s trouble are caused, and long sexually transmitted disease (STD) trouble has higher prevalence and the mortality rate relevant with surgical repair.
For example in treating organic and functional mitral regurgitation, still need the equipment that is used for the treatment of the heart valve function obstacle, the system and method for simple, cost-efficient and less infringement.
Summary of the invention
The invention provides the equipment, system and the method that are used for the shaping heart valve annulus, and comprise the usage of adjustable bridge implant system.
One aspect of the present invention provide a kind of the bridge implant system is installed be used for the treatment of the mitral equipment of heart, system and method.Described bridge implant system comprises: bridgeware, and it forms certain size and is constructed to cross over left atrium between great cardiac vein and the interatrial septum; The back axle stopper, it is connected to described bridgeware and is docked at the interior vein tissue of described great cardiac vein; The propons stopper, it is connected to described bridgeware and is docked at interatrial septum tissue in the right atrium; And the bridgeware governor motion, its shortening and/or prolong described bridgeware.At least one comprises described bridgeware governor motion in described back axle stopper and the described propons stopper.Described implant system comprises also and relocates ring that the wherein said ring that relocates comprises at least one radio opaque markers thing.
Described bridgeware can comprise, for example metal material or polymeric material, the perhaps structure of the structure of form of wires or polymer line form, perhaps suture material, the perhaps mammiferous tissue of pericardium of pericardium of pericardium of horse or pig or cattle or preservation.Described bridgeware also comprises the discontinuous pearl that stops, and regulates with discontinuous length to allow described bridgeware.
Described bridgeware can be regulated shortening described bridgeware by reversing along first direction, and/or described bridgeware reverses to prolong described bridgeware along second direction.Described bridgeware may further include the ring of bridgeware, and the ring of wherein said bridgeware makes the length doubles of described fitting, and the adjusting ratio of 1/2 unit than 1 unit is provided.
In one aspect of the invention, described bridgeware comprises Nitinol (Nitinol) line of braiding and comprises the bridge stopper of one, the nitinol wire of described braiding has first end and second end, described first end comprises the preform part, thereby when described bridgeware is implanted, form the bridge stopper of described one.
In another aspect of the present invention, described bridgeware can comprise dentation tape portion or perforation tape portion or the screw spindle part to small part that extends through in described propons stopper and the described back axle stopper one.Dentation tape portion or perforation tape portion or screw spindle part can also be connected to described bridgeware.
Another aspect of the present invention provides equipment, system and the method that is used to regulate implant tension force (being length), and described implant system comprises: bridgeware, and it forms certain size and is constructed to cross over left atrium between great cardiac vein and interatrial septum; The back axle stopper, it is connected to described bridgeware and is docked at the interior vein tissue of described great cardiac vein; The propons stopper, it is connected to described bridgeware and is docked at interatrial septum tissue in the right atrium; And the bridgeware governor motion, its shortening and/or prolong described bridgeware.Comprise the conduit with near-end and far-end, described conduit has governor motion at its near-end.Described governor motion can comprise, for example hook-shaped top.Described implant system also comprises the ring that relocates that is connected to described implant system.
Another aspect of the present invention provides and has been used for the bridge implant system is arranged on equipment, system and method in the heart chamber, described bridge implant system comprises: bridgeware, and it forms certain size and is constructed to cross over left atrium between great cardiac vein and interatrial septum; The back axle stopper, it is connected to described bridgeware and is docked at the interior vein tissue of described great cardiac vein; The propons stopper, it is connected to described bridgeware and is docked at interatrial septum tissue in the right atrium; And the bridgeware governor motion, its shortening and/or prolong described bridgeware.At least one can comprise described bridgeware governor motion in described back axle stopper and the described propons stopper.Described implant system can comprise also and relocate ring that the wherein said ring that relocates can comprise at least one radio opaque markers thing.
In one aspect of the invention, operate described governor motion to prolong or to shorten bridgeware.This adjusting can repeat, up to the bridgeware that obtains desired length.Further, allow implant system before the step of the described governor motion of repetitive operation, to place preset time.Conduit can be connected to described bridgeware governor motion, and described conduit is used for operating bridge fitting governor motion.Alternatively, conduit can also be connected to bridgeware, and described conduit is used for prolonging or shortening described bridgeware.
In another embodiment, equipment, system and method that the bridge implant system is implanted in the heart chamber further comprise: conduit is provided, described conduit comprises near-end and far-end, and described conduit has first governor motion at its near-end, and has second governor motion at its near-end; Described first governor motion is connected in described back axle stopper and the described propons stopper one; Described second governor motion is connected to described bridgeware; Operate described first governor motion to allow to regulate described bridgeware; Operate described second governor motion to prolong or to shorten described bridgeware; And operate described first governor motion once more to retighten described bridgeware.
One aspect of the present invention provides equipment, system and the method that comprises the bridge implant system, and described bridge implant system comprises: bridge stopper housing, and it has length and width; Aperture, it extends through the length of described bridge stopper housing, and described aperture forms certain size and is constructed to allow bridgeware to extend through the partial-length at least of described aperture; And governor motion, it is connected to described bridge stopper housing to allow to regulate the length of described bridgeware.Described governor motion can comprise conduit, and described conduit is connected to described bridge stopper releasedly to activate described governor motion.And described governor motion can be arranged in the intravital aperture of described bridge stopper shell.Described governor motion can allow only to prolong described bridgeware or only shorten described bridgeware, perhaps allows to prolong described bridgeware and shortens described bridgeware.Described governor motion can form certain size and be constructed to allow repeatably to regulate.Described bridge stopper can also comprise and relocates element, and the described element that relocates further can comprise at least one radio opaque markers thing.
In one embodiment, bridge stopper governor motion comprises static state, and wherein said bridge stopper governor motion needs to allow to regulate the necessary forward actuation force of described bridgeware thus at the described bridgeware of the static limit of described governor motion.
In another embodiment, described bridgeware comprises the discontinuous pearl that stops, and regulates with discontinuous length to allow described bridgeware.Described bridgeware also comprises dentation tape portion or the perforation tape portion or the screw spindle part to small part of the aperture that extends through in the described bridge stopper housing.
Another aspect of the present invention provides equipment, system and the method that comprises the bridge implant system with adjustable bridge stopper, described bridge stopper comprises: bridge stopper housing, described housing comprises inside and outside, and described housing has length and width; Aperture, it extends through the length of described bridge stopper housing, and described aperture forms certain size and is constructed to allow bridgeware to extend through the partial-length at least of described aperture; And governor motion, it is connected to described bridge stopper housing to allow to regulate described bridgeware.Described governor motion can comprise described inside of rotation or described outside.And described inside can be arranged in the described outside fully, and perhaps described inside can partly be extended in the outside of described outside.
Another aspect of the present invention provides equipment, system and the method that comprises the bridge implant system with adjustable bridge stopper, described bridge implant system comprises: bridgeware, and it forms certain size and is constructed to cross over left atrium between great cardiac vein and interatrial septum; The first bridge stopper, it is connected to described bridgeware; And the second bridge stopper, it is connected to described bridgeware, the described second bridge stopper comprises: bridge stopper housing, it has length and width, aperture, it extends through the length of described bridge stopper housing, and described aperture forms certain size and is constructed to allow bridgeware to extend through the partial-length at least of described aperture, and governor motion, it is connected to described bridge stopper housing to allow to regulate described bridgeware.Described bridge stopper housing may further include inside and outside, and wherein said governor motion comprises described inside of rotation or described outside, thereby allows bridgeware to prolong or shortening.
Another aspect of the present invention provides equipment, system and the method for the bridge stopper that is used to regulate implant system, and described bridge stopper comprises: bridge stopper housing, and it has length and width; Aperture, it extends through the length of described bridge stopper housing, and described aperture forms certain size and is constructed to allow bridgeware to extend through the partial-length at least of described aperture; And governor motion, it is connected to described bridge stopper housing to allow to regulate the length of described bridgeware.Described governor motion comprises conduit, and described conduit is connected to described bridge stopper releasedly to activate described governor motion.And described governor motion can be arranged in the intravital aperture of described bridge stopper shell.Described governor motion can allow only to prolong described bridgeware or only shorten described bridgeware, perhaps allows to prolong described bridgeware and shortens described bridgeware.Described governor motion forms certain size and is constructed to allow repeatably to regulate.Described bridge stopper can also comprise and relocates element, and the described element that relocates further can comprise at least one radio opaque markers thing.
Another aspect of the present invention provides equipment, system and the method for the length of the bridgeware that comprises the bridge implant system in the chamber that is used to regulate heart, described equipment, system and method comprise provides the bridge stopper, described bridge stopper: bridge stopper housing, it has length and width; Aperture, it extends through the length of described bridge stopper housing, and described aperture forms certain size and is constructed to allow bridgeware to extend through the partial-length at least of described aperture; And governor motion, it is connected to described bridge stopper housing and regulates the length of described bridgeware with permission, and operates described governor motion subsequently to prolong or to shorten described bridgeware.
In one aspect of the invention, this adjusting can repeat, up to the bridgeware that obtains desired length.Further, allow implant system before the step of the described governor motion of repetitive operation, to place preset time.Conduit can be connected to described bridge stopper governor motion, and described conduit is used to operate described governor motion.Alternatively, conduit can also be connected to bridgeware, and described conduit is used for prolonging or shortening described bridgeware.
In another embodiment, equipment, system and the method for length that is used to regulate the bridgeware of the bridge implant system in the chamber of heart further comprises: conduit is provided, described conduit comprises near-end and far-end, described conduit has first governor motion at its near-end, and has second governor motion at its near-end; Described first governor motion is connected in described back axle stopper and the described propons stopper one; Described second governor motion is connected to described bridgeware; Operate described first governor motion to allow to regulate described bridgeware; Operate described second governor motion to prolong or to shorten described bridgeware; And operate described first governor motion once more to retighten described bridgeware.
Other characteristic of the present invention and advantage will be clearly based on appended explanation, accompanying drawing and claim.
Description of drawings
Fig. 1 is the preceding bitmap of the anatomy of human heart, and wherein part is removed and with the cross section inner heart chamber and adjacent structure is shown.
Fig. 2 is a bitmap on the anatomy in cross section of human heart, it shows the aortic valve between Tricuspid valve, the Bicuspid valve in the left atrium and right atrium and the left atrium in the right atrium, wherein open at ventricular diastole (ventricular filling) the period three cusp and the Bicuspid valve of cardiac cycle, and aortic valve and valve of pulmonary trunk closure.
Fig. 3 is a bitmap on the anatomy in cross section of the human heart shown in Fig. 2, and wherein in Ventricular systole (ventricle emptying) the period three cusp and the Bicuspid valve closure of cardiac cycle, and aortic valve and valve of pulmonary trunk are opened.
Fig. 4 is the anatomy anteposition perspective view of left atrium and right atrium, and wherein part is removed and shown the inside and the dependency structure of heart chamber with the cross section, such as fossa ovalis, coronary sinus and great cardiac vein.
Fig. 5 is the anatomy outside figure of human heart, and wherein the inside and the structure that is connected to mitral related muscles and tendon of left ventricle is removed and illustrated with the cross section to part.
Fig. 6 is the anatomy outside figure of human heart, wherein the part structure removing and the inside of left ventricle and left atrium is shown and is connected to mitral related muscles and tendon with the cross section.
Fig. 7 is healthy mitral bitmap of going up, and its mesopetalum leaf is closed and joint when the Ventricular systole peak systolic pressure.
Fig. 8 is a bitmap on the anatomy in cross section of human heart, and wherein the normal Bicuspid valve shown in Fig. 7 is closed during the Ventricular systole (ventricle emptying) of cardiac cycle.
Fig. 9 is mitral bitmap of going up of malfunction, and its mesopetalum leaf can not engage during the Ventricular systole peak systolic pressure, thereby causes mitral incompetence.
Figure 10 A and Figure 10 B are the anatomy anteposition perspective views of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has back axle stopper and the propons stopper in the great cardiac vein of being arranged on, and comprise diaphragm element, described diaphragm element is arranged on the interatrial septum, and Interatrial bridgeware extends to the interatrial septum from the central region of ring in the path of basic straight shape.
Figure 10 C is the anatomy anteposition perspective view of the selectable embodiment of the implant system shown in Figure 10 A and Figure 10 B, it shows relocating device, described relocating device is arranged on the front side of implant, and a few days, several months or the several years that are used for after initial program or adjusting remove or regulate implant system.
Figure 10 D is the anatomy anteposition perspective view of the selectable embodiment of the implant system shown in Figure 10 A and Figure 10 B, and it shows the propons stopper with diaphragm element.
Figure 11 A is the anatomy anteposition perspective view of left atrium and right atrium, wherein the implant system that has the type shown in Figure 10 A and the 10B is removed and illustrated with the cross section to part, wherein the front area of implant extends through by structure, as diaphragm element, and in the interatrial septum and be arranged in superior vena cava.
Figure 11 B is the anatomy anteposition perspective view of left atrium and right atrium, wherein the implant system that has the type shown in Figure 10 A and the 10B is removed and illustrated with the cross section to part, wherein the front area of implant extends through by structure, as diaphragm element, and in the interatrial septum and be arranged in postcava.
Figure 11 C is the anatomy anteposition perspective view of left atrium and right atrium, wherein the implant system that has the type shown in Figure 10 A and the 10C is removed and illustrated with the cross section to part, wherein the front area of implant is positioned on the interatrial septum, and in superior vena cava and the postcava.
Figure 12 A is the side view of diaphragm element, and described diaphragm element can be used as the parts of the implant system of the type shown in Figure 10 A and Figure 10 B.
Figure 12 B is the side view of the unfolded diaphragm element of the type shown in Figure 21 A, and it shows described member the bore portion that described barrier film passes existence is clipped in the middle.
Figure 12 C is the perspective view of the selectable embodiment of the diaphragm element shown in Figure 12 A, and it shows center or near grommet it or the similar protectiveness equipment that is arranged on diaphragm element.
Figure 13 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum, and Interatrial bridgeware extends from the exterior lateral area of encircling in the path of basic straight shape substantially.
Figure 14 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has the Background Region that is arranged in great cardiac vein and is positioned at front area on the interatrial septum, Interatrial bridgeware be bent upwards or arcual path in extend from the exterior lateral area of ring substantially.
Figure 15 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated to cut and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum, and Interatrial bridgeware extends from the exterior lateral area of encircling in reclinate path substantially.
Figure 16 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum, Interatrial bridgeware trigone extends along curved path, the central region bending from encircling substantially around the trigone of ring simultaneously.
Figure 17 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum, Interatrial bridgeware extends along curved path, simultaneously around the trigone of ring substantially from the central region bending of ring, and along raising towards the arc of the dome of left atrium.
Figure 18 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises the Interatrial bridgeware of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum, Interatrial bridgeware extends along curved path, the central region bending from encircling substantially around the trigone of ring, and downward-sloping towards the plane of valve.
Figure 19 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises two Interatrial bridgewares of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum respectively, and Interatrial bridgeware is all along the directly zones of different extension of the path of shape from encircling substantially.
Figure 20 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises two Interatrial bridgewares of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum respectively, and all the adjacent area from ring extends Interatrial bridgeware along the path that is roughly curve.
Figure 21 is the anatomy anteposition perspective view of left atrium and right atrium, wherein part is removed and is illustrated with the cross section and has implant system, described implant system comprises three Interatrial bridgewares of crossing over annulus of mitral valve, described bridgeware has Background Region that is arranged in great cardiac vein and the front area that is positioned on the interatrial septum respectively, two edges in the Interatrial bridgeware are roughly the path of straight shape extends from the zones of different of ring, and the 3rd Interatrial bridgeware extends towards the trigone that encircles along the path that is roughly curve.
Figure 22 A and Figure 22 B show the sectional view of the effect of bridge stopper, and described bridge stopper uses together with the inwall that does not rely on septum wall and great cardiac vein in conjunction with the implant shown in Figure 10 A to 10C and moves forward and backward.
Figure 23 to Figure 30 is implant system representational based on the equipment of conduit and the internal anatomy of step of describing to be used to implant the type shown in Figure 10 A to Figure 10 C.
Figure 31 is a left atrium and the anatomy sectional view of relevant mitral valve apparatus, and it shows mitral malfunction.
Figure 32 is a bitmap on the venous anatomy of human heart, and it shows the implant system that has the type shown in Figure 10 A and the 10B.
Figure 33 is that it shows the implant system that has the type shown in Figure 10 A and the 10B, and shows the suitable joint of mitral leaflet generally along the anatomy sectional view of the implant system of the line 33-33 incision of Figure 32.
Figure 34 A to Figure 34 D is the sectional view that is used for guide line is connected to the aluminium hydraulic pressed connecting pipe of bridgeware, and shows the multiple variation in employed crimping.
Figure 35 A is patient's the anatomy partial view of inlet point of describing to be used for the implantation of implant system, and it also shows two positions from the enterable annular guide line of engine body exterior.
Figure 35 B is the internal anatomy of representational selectable equipment based on conduit of describing to be used to implant the implant system of the type shown in Figure 10 A to Figure 10 C, and shows the bridgeware that is passed vascular structure by annular guide line pulling.
Figure 36 A shows the patient's of the bridge stopper that is connected to bridgeware anatomy partial view, and described bridgeware is prepared pulling and/or promoted to pass vascular structure and it is arranged in the great cardiac vein.
Figure 36 B is the internal anatomy of representational selectable equipment based on conduit of describing to be used to implant the system of the type shown in Figure 10 A to Figure 10 C, and shows the bridge stopper that is arranged in the great cardiac vein.
Figure 37 A is the perspective view at the conduit of the implant system that is used to implant the type shown in Figure 10 A to Figure 10 C.
Figure 37 B shows the partial section of the magnetic head of the conduit shown in Figure 37 A.
Figure 38 is the perspective view at the another kind of conduit of the implant system that can be used to implant the type shown in Figure 10 A to Figure 10 C.
Figure 39 is the interactional fragmentary, perspective view between the magnetic head of the magnetic head of the conduit shown in Figure 37 A and the conduit shown in Figure 38, and it shows the guide line that extends out and enter another magnetic head from a magnetic head.
Figure 40 is the anatomy fragmentary, perspective view of the magnetic catheters head shown in Figure 39, and one of them conduit is illustrated in the left atrium, and a conduit is illustrated in the great cardiac vein.
Figure 41 is the perspective view of the another kind of conduit that uses in can the implantation at the implant system of the type shown in Figure 10 A to Figure 10 C.
Figure 42 A to Figure 42 C is the fragmentary, perspective view of the catheter tip that can use together with the conduit shown in Figure 41.
Figure 43 A is the T shape bridge stopper of the symmetric shape that can use together with the implant system of the type shown in Figure 10 A to 10C or the perspective view of member.
Figure 43 B is the perspective view of the selectable embodiment of the T shape bridge stopper shown in Figure 43 A, and it shows asymmetric and a bridge stopper that is shorter than other.
Figure 44 A is the sectional view of the bridge stopper that can use together with the implant system of the type shown in Figure 10 A to Figure 10 D, and it shows the control characteristic at the make position bridgeware.
Figure 44 B is the sectional view of the bridge stopper of the type shown in Figure 44 A, and it shows the control characteristic at the open position bridgeware.
Figure 45 A is the anatomy fragmentary, perspective view of selectable magnetic catheters head, and one of them conduit is illustrated in the left atrium, and a conduit is illustrated in the great cardiac vein, and the structure of side to the end is shown.
Figure 45 B is the partial section of the selectable magnetic catheters head of the type shown in Figure 45 A, and it shows wall and the left atrium that pierces through great cardiac vein and extends to the guide line that receives in the conduit.
Figure 45 C is the fragmentary, perspective view of the selectable magnetic head of the type shown in Figure 45 B.
Figure 46 is the anatomy fragmentary, perspective view of another kind of selectable embodiment that is used for the magnetic catheters head of the type shown in Figure 45 A, and it illustrates the side to lateral structure.
Figure 47 is the perspective view of selectable embodiment of the implant system of the type shown in depiction 10A to Figure 10 D, and it shows the usage that has the bridgeware control characteristic and also comprise the bridge stopper that relocates ring.
Figure 48 is the perspective view of selectable embodiment of describing to have the bridge stopper of bridgeware control characteristic, and shows the bridgeware control characteristic at open position.
Figure 49 is the perspective view of the bridge stopper shown in Figure 48, and shows the bridgeware control characteristic in make position.
Figure 50 to Figure 52 is the perspective view of selectable embodiment of describing to have the bridge stopper of bridgeware control characteristic.
Figure 53 is the sectional view of the bridge stopper of the type shown in Figure 52, and it shows the bridgeware control characteristic in make position, and shows the adjusting catheter tip before being used to regulate bridgeware being connected to the bridge stopper.
Figure 54 is the sectional view of the bridge stopper of the type shown in Figure 52, and it shows the bridgeware control characteristic at open position, and shows the adjusting catheter tip that is connected to the bridge stopper and is used to regulate bridgeware.
Figure 55 is the vertical view of selectable embodiment of describing to have the bridge stopper of bridgeware control characteristic.
Figure 56 is the front view of the bridge stopper shown in Figure 55, and it shows the maintenance protuberance in the bridge stopper.
Figure 57 A is the sectional view of selectable embodiment with bridge lock of bridgeware control characteristic, and it shows the bridgeware in make position.
Figure 57 B is the perspective view of seeing in the lock of the bridge shown in Figure 57 A into, and it shows the bridgeware in make position.
Figure 57 C is the vertical view of the bridge lock shown in Figure 57 A, and it shows the bridgeware in make position.
Figure 58 A is the sectional view of the bridge lock shown in Figure 57 A, and it shows the bridgeware in not closed position.
Figure 58 B is the perspective view of seeing in the lock of the bridge shown in Figure 57 A, and it shows the bridgeware in not closed position.
Figure 58 C is the vertical view of the bridge lock shown in Figure 57 A, and it shows the bridgeware in not closed position.
Figure 59 A to Figure 60 C is the view of the selectable embodiment of the bridge lock shown in Figure 57 A to 58C, and shows and have revolving door and reset the selectable bridge lock of bridge lock to regulate to provide convenience mechanism.
Figure 61 is the perspective view of the selectable embodiment of bridge lock, and described bridge lockset has the bridgeware control characteristic, and shows the bridgeware control characteristic at open position.
Figure 62 is the perspective view of the re-entrant part of the bridge lock shown in Figure 61, and does not have bridgeware.
Figure 63 is the sectional view generally along the re-entrant part of the bridge lock shown in Figure 62 of the line 63-63 incision of Figure 62.
Figure 64 is the perspective view of the engaging member of the bridge lock shown in Figure 61.
Figure 65 is the front view of the bridge lock shown in Figure 61, and shows in the bridgeware control characteristic of locked position not.
Figure 66 is the front view of the bridge lock shown in Figure 61, and shows the bridgeware control characteristic at locked position.
Figure 67 is the perspective view of the bridge lock shown in Figure 61, and shows the adjusting conduit with pair of interacting catheter tip, and inner torquer top is arranged on the dentation bridgeware, and external torque device top is arranged on bridge and locks.
Figure 68 is the perspective view of the selectable embodiment of the bridge lock shown in Figure 61, and described bridge lockset has internal whorl to allow to regulate the screw thread bridgeware.
Figure 69 is the perspective view of the screwed part of the bridge lock shown in Figure 68.
Figure 70 is the sectional view generally along the screwed part of the bridge lock shown in Figure 69 of the line 70-70 incision of Figure 69.
Figure 71 is the perspective view of the cover joint parts of the bridge lock shown in Figure 68.
Figure 72 is the anatomy anteposition perspective view of left atrium and part right atrium, wherein the selectable implant system that has the type shown in Figure 10 A to Figure 10 D is removed and shown with the cross section to part, described selectable implant system comprises the bridgeware of the multicomponent of crossing over annulus of mitral valve, and relocating ring, the described ring that relocates is used for removing or regulating implant system.
Figure 73 is the anatomy anteposition perspective view of left atrium and part right atrium, wherein the selectable implant system that has the type shown in Figure 10 A to Figure 10 D is removed and shown with the cross section to part, described selectable implant system comprises the dentation tape bridgeware of crossing over annulus of mitral valve, and relocating ring, the described ring that relocates is used for removing or regulating implant system.
Figure 74 and Figure 75 are the perspective views of the selectable embodiment of the T shape bridge stopper of the type shown in Figure 10 A to Figure 10 D or member, and it shows the T shape bridge stopper with bridgeware control characteristic.
Figure 76 and Figure 77 are the perspective views of the selectable embodiment of the T shape bridge stopper of the type shown in Figure 10 A to Figure 10 D or member, and it shows the T shape bridge stopper that only has bridgeware tension characteristic.
Figure 78 is the perspective view of selectable embodiment of the implant system of the type shown in depiction 10A to Figure 10 D, and it shows and uses the tape bridgeware.
Figure 79 is the perspective view of selectable embodiment of the implant system of the type shown in depiction 10A to Figure 10 D, and it shows and uses the ring-type bridgeware.
Figure 80 A is the perspective view of selectable embodiment of the implant system of the type shown in depiction 10A to Figure 10 D, and it shows the bridgeware that uses braiding, and described bridgeware comprises curved end and forms the propons stopper in the front side.
Figure 80 B is the side view of curved end of bridgeware of the braiding of Figure 80 A, and it shows the curved end in a kind of curvature state.
Figure 80 C is the side view of curved end of bridgeware of the braiding of Figure 80 A, and it shows the curved end in another kind of curvature state.
The specific embodiment
Although disclosure of the present invention is detailed and definite, can make those skilled in the art the present invention is put into practice, yet the specific embodiment disclosed herein only is the example that the present invention who implements with other ad hoc structure is carried out.Though preferred implementation of the present invention is described, can make amendment to details yet do not break away from the present invention who limits by claim.
I. be used for directly shortening wearing of heart valve annulus minor axis every implant
A. implant structure
Figure 10 A to Figure 10 D shows the embodiment of implant 10, and described implant 10 forms certain size and is constructed to and extends through left atrium along cardinal principle direction from front to back, thereby crosses over annulus of mitral valve.Implant 10 comprises crosses over zone or bridgeware 12, and described bridgeware 12 has back axle stop area 14 and propons stop area 16.
Back axle stop area 14 forms certain size and is constructed to allow bridgeware 12 to be arranged in the zone of atrial tissue of annulus of mitral valve top, back.Because described zone can provide substantially than the piece of tissue that more is used to obtain to control back axle stop area 14 in the tissue regions that is located on or near the back annulus of mitral valve, therefore described zone is preferred.The joint that is organized in described ring top position also can reduce the danger of damage circumflex branch of coronary artery.Situation than small scale is, above the great cardiac vein of circumflex branch of coronary artery on aspect the left atrium of great cardiac vein by and be positioned at its inboard, thereby between the endocardium of great cardiac vein and left atrium.Yet, owing to the mode that the relative left atrium of active force in the back axle stop area is oriented to upwards and inwardly and not compresses with the long axis along great cardiac vein, other technology that therefore compares the tissue of compression great cardiac vein in this area reduces the circumflex artery possibility of compressing.Yet it is narrow that coronary angiography should disclose circumflex artery, and the back axle stopper of symmetric shape can be replaced by the bridge stopper of asymmetric shape, and for example T shape member situation than other weak point is avoided the compression to the circumflex artery cross point thus.This asymmetric form can at first be selected based on angiogram.
Go back because of some other reason in addition, and can use asymmetric back axle stopper.When finding that the patient has the great cardiac vein of serious narrow tip, select described asymmetric back axle stopper, wherein asymmetric bridge stopper is used to avoid blocking described vascular better.And, select asymmetric bridge stopper and be because its for example be used for when deformity or asymmetric mitral situation along the back annulus of mitral valve select differentially to reach preferably act on difference active force to optimize treatment.
Alternatively, shown in Figure 11 A and 11B, propons stop area 16 can be arranged in superior vena cava (SVC) or the postcava (IVC) or is arranged in superior vena cava or postcava when passing barrier film and enter right atrium, originally is in but not be arranged on barrier film.
In use, crossing over zone or bridgeware 12 can be arranged between two bridge stop areas 14 and 16 with certain tension force.Thus, implant 10 is used for direct mechanicals efforts generally along passing left atrium from back to preceding direction.Described direct mechanical force can be used for shortening the minor axis (the line P-A among Fig. 7) of ring.For this reason, implant 10 can also be along the long axis (the line CM-CL among Fig. 7) that encircles reactively to the ring shaping and/or reactively to the anatomical structure shaping around other.Yet, should be understood that the existence of implant 10 can be used for stable tissue near heart valve annulus, and do not influence the length of minor axis or long axis.
It is to be further understood that when axis is arranged in other valve structure affected axis can be because the dissection of surrounding tissue also can not be long axis and minor axis.And, for therapeutic purposes, when leaking appearred in Bicuspid valve when most of the time, implant 10 only need be during a part of cardiac cycle, as beginning and relaxing period later stage and systole when being full of blood is early interim in ventricular systolic contraction, ring is carried out shaping when heart.For example, implant 10 can form the later stage limit collar outside displacement of certain size with the diastole of ventricular diastole when the ring extension.
The mechanical force of being passed left atrium by implant 10 effects can make heart valve annulus and lobe leaf recover more normal anatomic shape and tension force.More normal anatomic shape and tension force help later stage and the ventricular systolic early stage joint of lobe leaf at ventricular diastole, thereby have reduced mitral incompetence.
In the most basic form of implant 10, implant 10 is by the metal or the polymeric material of biocompatibility, perhaps is suitable for applying, permeate or handles with material and have the metal or the polymeric material of biocompatibility, and perhaps the combination of these materials is made.Described material also is contemplated to be radiopaque or is combined with radiopaque characteristic conveniently to carry out fluoroscopic visualization.
B. back axle stop area
The certain size of back axle stop area 14 formation also is constructed to be arranged in the left atrium that encircles the top position or the left atrium place, in the left atrium after promptly being arranged on above the annulus of mitral valve or near it.
In the embodiment that illustrates, back axle stop area 14 is depicted as the height that is arranged on great cardiac vein substantially, described great cardiac vein near and be parallel to most of back annulus of mitral valve and advance.In radiopaque equipment is arranged on the branch of coronary sinus or when injecting contrast agent wherein, the branch of described coronary sinus can provide strong and fluorescent labeling reliably.As previously mentioned, compare with the program that directly acts on annulus of mitral valve and also reduced the danger of infringement circumflex branch of coronary artery and to its danger that damages in the position that bridgeware 12 is fixed on described ring top.In addition, the position of ring top can guarantee not contact valve lobe leaf, allows to engage and reduced the danger of mechanical damage thus.
The atrial tissue that great cardiac vein also is provided with wherein relatively thin non-fiber is easy to the site that increases and reinforce.In order to strengthen the maintenance and the control of back axle stop area 14 to wherein mainly being the heart tissue of non-fiber, and in order to improve the distribution of the power that applies by implant 10, back axle stop area 14 can comprise back axle stopper 18, and described back axle stopper 18 is arranged in the great cardiac vein and docks vein tissue.Thereby can with still keep to organize tangible maintenance with control a period of time and the mode that can not split (with clinical relevant time range in explain), back axle stop area 14 is fixed in the part of the non-fiber of heart.
C. propons stop area
Shown in Figure 10 A to Figure 10 D, septum wall is passed in the ring top position of top, the plane of propons stop area 16 pro-annulus of mitral valve.In the distance above the ring of front side roughly above the ring at rear side above distance or its.As previously pointed out, propons stop area 16 is being near the lower edge of fossa ovalis or its shown in Figure 10 A to Figure 10 D, although consider need prevent to diaphragm tissue and around damage and in fossa ovalis or the outside can use other site, more bottom or site, top.
By bridgeware 12 being arranged on the height of the ring top in the right atrium, described bridgeware 12 fully left atrium outside and just in time be arranged on preceding annulus of mitral valve above, implant 10 is avoided pro-annulus of mitral valve place or can not be realized near the endovascular attached of preceding annulus of mitral valve place, wherein have the edge of extremely thin ring tissue, front portion, described edge by preceding lobe leaf define, the bottom is defined by the aorta efferent tract and inboard atrioventricular node by conducting system defines.Before annulus of mitral valve be that the non-coronary valve leaf of aortic valve passes central fibrous body and is attached to the position of annulus of mitral valve.The forward position of the ring height of implant 10 in right atrium avoids encroaching on aortic valve and atrioventricular node reaches its danger that damages.
Can be contemplated that atomic little pulling force acts on barrier film by propons stop area 16, the active force that acts on the diaphragm element 30 will disperse on suitable zone, and can not impact valve, vascular or conducting tissue.When pulling force or tension force are sent to ring downwards, realized the shortening of minor axis.The diaphragm element that has certain degree of hardness flexibly is preferred, because when the tension force that acts on bridgeware increases, described diaphragm element is easy to make the direction of bridgeware tension make focus produce less contraction along left atrium.Diaphragm element 30 should also have the surface of low-profile configuration and very anti-cleaning to reduce the thrombosis of the equipment that adopts in heart.Diaphragm element also can have folding structure and unfolded structure.Diaphragm element 30 comprises that also cover joint 31 (referring to Figure 12 A and Figure 12 B) are to allow attached bridge stopper 20.Diaphragm element 30 also comprises the middle part that is arranged on diaphragm element or near the grommet it or similarly protects equipment 32, carries out unconfined move (referring to Figure 12 C) thereby for example allow in the process of regulating bridgeware 12 bridgeware 12 to pass diaphragm element.Cover joint 31 also can provide this specific character.
The barrier film pull bar can use with the active force (referring to Figure 11 C) that distributes equably along barrier film together in conjunction with diaphragm element 30 and propons stopper 20.Alternatively, the equipment among IVC or the SVC can be used as bridge and stops site (referring to Figure 11 A and Figure 11 B), but not is limited to barrier film.
Be described having radiopaque bridge lock and tissue site is better distinguished above ring respectively fluorescently-labeled back axle stop area 14 and the location of propons stop area 16, not only can be to the important structure of key, as to the left coronary valve point of circumflex artery, atrioventricular node and aortic valve with non-coronary valve point causes damage or the part impacts, and the site of concentrating, ring top and do not rely on tissue and directly the penetrating/thrust of tension loading/keep organize control between the attachment mechanism.On the contrary, can use physical arrangement and such as support, T shape member, and the distribution of forces mechanism of diaphragm element and so on, described member can better provide the attached or butt joint of mechanical shaft and bridge lock, and can distribute preferably by the potential tearing force of organizing of described member.Further, bridge stops site 14,16 does not need the operator to use complicated imaging.
In implantation process or broken away from these restrictions after implanting and to be convenient to the implant position is regulated.Bridge stops site 14,16 reclaims implant 10 by catching and shear bridgeware 12 subsequently at the either side of left atrial wall fully in the atrium, wherein implant 10 is exposed from left atrial wall.Shown in Figure 10 C, such as hook or encircle relocating device 24 and be set to help to reenter bridge stopper site 14,16 and carry out adjusting in the future or allow implant to remove allowing.Relocating device after the initial program or a few days after regulating, several months or even the several years allow implant is regulated or removed.
D. the orientation of bridgeware
In the embodiment shown in Figure 10 A to Figure 10 D, implant 10 is depicted as the leap left atrium, be higher than the rear portion point beginning that annulus of mitral valve is roughly the focus of mid point, and along directly to the zone of barrier film middle front part focus substantially directly the path of shape advance along anterior direction.Shown in Figure 10 A to Figure 10 D, the leap zone of implant 10 or bridgeware 12 can preforms or are configured to extend in the path of the straight shape of described cardinal principle above the plane of valve, and height is towards the plane of ring or away from can not departing from significantly on the plane of ring, except as pointed by difference in height between localized Background Region and the front area.
If desired, can give the outside in described track or inboard depart from and/or depart from up or down influence the force vector that implant 10 acts on or the essence and the direction of a plurality of force vectors.Should be understood that cross over zone or bridgeware 12 can preform or be configured to have departing from of multiple medial/lateral and/or downwards/downward and obtain the ring of needs and/or the modification in construction in atrium with the needs of considering concrete treatment and patient's different shape.And, can also give departing from the track of bridgeware to avoid at blood vessel such as the high flow rate in the heart chamber of left atrium.
For example, as shown in figure 13, implant 10 is depicted as the leap left atrium, in Background Region (that is, away from the barrier film) beginning near the outside rhizoma sparganic that encircles.Alternatively, Background Region also can be in the position near the interior rhizoma sparganic (that is, near barrier film) that encircles.From any of these Background Regions, implant 10 can directly extended along forward direction in the path of the straight shape in barrier film middle front part zone.As shown in figure 13, similar Figure 10 A, the leap zone of implant 10 or bridgeware 12 can preforms or are configured to extend in the path of the straight shape of cardinal principle above the plane of valve, and highly can be not significantly towards the plane of ring or away from departing from the plane of ring, if except the difference in height that between Background Region and front area, exists pointed.
Do not consider the concrete location (referring to Figure 14) of Background Region, the leap zone of implant 10 or bridgeware 12 can preforms or are configured to above the plane of valve towards the dome of the left atrium bow that makes progress.Alternatively (referring to Figure 15), the leap zone of implant 10 or bridgeware 12 can preforms or are configured to towards the plane of the valve of ring downward-slopingly, extend near the plane of valve, but can avoid interacting between the valve lobe leaf.Perhaps, still alternatively (referring to Figure 16), the leap zone of implant 10 or bridgeware 12 can preforms or are configured to follow curvilinear path, described track before leading to front area towards the rhizoma sparganic (inboard or the outside) of ring.
Certainly, to depart from the multiple combination that departs from up/down be feasible to the outboard/inboard of the leap zone of implant 10 or bridgeware 12.For example, as shown in figure 17, leap zone or bridgeware 12 can be followed the curvilinear path in rhizoma sparganic (inboard or the outside) bent around of ring, and with the arc lifting away from valve plane.Perhaps, as shown in figure 18, leap zone or bridgeware 12 can be followed the curvilinear path in rhizoma sparganic (inboard or the outside) bent around of ring, and downward-sloping towards valve plane.
Do not consider orientation, can install to form implant system 22 more than one implant 10.For example, Figure 19 shows and comprises and the outside implant 10L of described implant 10 consistent types and the system 22 of inboard implant 10M.Figure 19 shows implant 10L and the 10M that is arranged on public propons stop area 16.Should be understood that implant 10L and 10M also comprise isolated propons stop area.
One of them or two implant 10L and 10M can be straight shape (as Figure 13), or bow (as Figure 14) upwards, or are bent downwardly (as shown in figure 15).Given system 10 can comprise the heteroid outside or inboard implant 10L and 10M.And given system 10 can also comprise the implant 10 more than two.
Figure 20 shows the curve implant 10L that comprises two types shown in Figure 16 and the system 22 of 10M.In Figure 20, curve implant 10L and 10M are depicted as and are positioned at public Background Region, and implant 10 also can be from isolated Background Region.One of them or two implant 10L and 10M can relative valve plane parallel (as Figure 16) or bow (as Figure 17) or be bent downwardly (as Figure 18) upwards.Given system 22 can comprise heteroid curve implant 10L and 10M.
Figure 21 shows the middle part implant 10D that comprises straight, the curve implant 10M of inboard and outside implant 10L straight.One, two or all implant 10 can be parallel to valve or bow or be bent downwardly upwards, as mentioned above.
E. back axle stopper and propons stopper
Should be understood that as the bridge stopper of back axle stopper and propons stopper that comprises described here and described the equipment that keeps bridgeware 12 with the state of tension releasedly.Shown in Figure 22 A and Figure 22 B, bridge stopper 20 and 18 is shown as and is fixed to bridgeware 12 releasedly, thereby in the part cardiac cycle when tension force reduces or be zero, thereby allow the bridge stop structure to move forward and backward, and do not rely on the inwall of interatrial septum and great cardiac vein.Selectable embodiment is described equally, and all embodiments provide this function.It is to be further understood that rear portion and forward big volume description are not limited to the bridge hold function, promptly the back axle stopper can forwardly use, and the propons stopper can use at the rear portion.
When the bridge stopper docked with diaphragm element or T shape member, for example, the bridge stopper allowed bridgeware freely to move in diaphragm element or around the diaphragm element, that is, bridgeware also is not attached to diaphragm element or T shape member.In this structure, bridgeware keeps with tension force by the bridge stopper, and diaphragm element or T shape member are used to distribute and are passed the active force of bigger surf zone by the bridgeware effect for this reason.Alternatively, for example when the bridge stopper was arranged on the cover joint top of diaphragm element or is fixed to diaphragm element cover joint, the bridge stopper can be mechanically connected to diaphragm element or T shape member.In this structure, bridgeware can not freely move around diaphragm element relative to the fixed-site of diaphragm element.
II. wear every the conventional method of implanting
Foregoing implant 10 or implant system 22 make in many ways and himself implant in the heart valve annulus.Implant 10 or implant system 22 can for example be implanted in opening the operative procedure of heart.Alternatively, implant 10 or implant system 22 can use based on the technology of conduit via the peripheral vein entry site and implant, described entry site can be under image guiding femoral vein or jugular vein in (via IVC or SVC), or equally under the image guiding from femoral artery through wear the approach that state tremulous pulse drive in the wrong direction of aorta to left atrium.
Alternatively, implant 10 or implant system 22 use the method for thoracoscope to pass the thoracic cavity and implant, or same access method implantation of passing the operation of right atrium under the guiding of image by other.Image guiding includes but not limited to fluorescence, ultrasonic, magnetic resonance, computed tomography, or its combination.
Figure 23 to Figure 30 shows under image guiding by via skin, based on the representative embodiments of the implant 10 of the type shown in program employing Figure 10 A to 10D of conduit.
Enter by entering femoral vein and jugular vein via the vascular of skin, or the conventional method of both combinations and realizing.As Figure 23 and shown in Figure 24, under image guiding, first conduit or great cardiac vein conduit 40 and second conduit or left atrium conduit 60 turned to pass vascular system and enter right atrium.The function of great cardiac vein (GCV) conduit 40 and left atrium (LA) conduit 60 is to form back axle end stop area.The conduit that leads to right atrium and left atrium can pass the route (when back a kind of state, be used for caval vein pull bar) of femoral vein to the route (in a kind of state in back, being used for the caval vein pull bar) of IVC or SVC or veins of upper extremity or cervical region vein to IVC or SVC.When the state of SVC, the simplest entering is from veins of upper extremity or cervical region Venous system; Yet IVC can also be by passing SVC and right atrium enters.Similarly, the simplest the entering to IVC is through femoral vein; Yet SVC can also be by passing IVC and right atrium enters.Figure 23, Figure 24, Figure 27, Figure 28 and Figure 29 show entering through SVC route and IVC route for the purpose of example.
Being implanted in this and at first describing of implant 10 and implant system 22 with four general steps.Each step and employed multiple instrument are described with extra details in trifle III subsequently hereinafter.And, can use selectable implantation step, and be described at trifle IV.The another kind of selectable embodiment of bridge stopper is described at trifle V, and the another kind of selectable embodiment of T shape instrument or bridge stopper is described at trifle VI, and the another kind of selectable embodiment of bridgeware is described at trifle VII.
First inserting step can be described as forming back axle stop area 14 substantially.As shown in figure 24, GCV conduit 40 enters right atrium through vascular system and handles.GCV conduit 40 passes through coronary sinus subsequently and enters great cardiac vein and handles.Second conduit or LA conduit 60 same process vascular systems also enter right atrium.LA conduit 60 passes through near the septum wall fossa ovalis place or the fossa ovalis subsequently and enters left atrium.Mullins
TMConduit 26 is set to aid in guide LA conduit 60 and enters left atrium.When GCV conduit 40 and LA conduit 60 were respectively in the relevant position in great cardiac vein and left atrium, the function of GCV and LA conduit 40,60 was structure back axle stop area 14.
Second step can be described as substantially forming and wear every bridgeware 12.Expansion conduit 24 via LA conduit 60 is used for location back axle stopper 18 and bridgeware 12 (referring to Figure 27) that is preferably pre-attached and predetermined length in great cardiac vein.Predetermined length (as, two meters) bridgeware 12 pass left atrium, pass fossa ovalis, pass vascular system and extend from back axle stopper 18, and preferably stop the outside that can enter body.Step is afterwards cut the bridgeware of predetermined length or is separated, thereby stays the part that extends to propons stopper 20 from back axle stopper 18.Alternatively, bridgeware 20 can not or separate in propons stopper 20 cutting, but bridgeware 20 can be allowed to extend to and is used for feasible subsequently recovery among the IVC.
Third step can be described as forming propons stop area 16 (referring to Figure 29) substantially.Bridgeware 12 passes diaphragm element 30 at first rotationally.Diaphragm element 30 passes Mullins conduit 26 subsequently and advances through bridgeware 12 under folding state, and is provided with near fossa ovalis place in right atrium or the fossa ovalis and expansion.The stopper 20 that advances is attached to bridgeware 12 and advances by diaphragm element 30, or alternatively the diaphragm element setting or launch after bridge stopper 20 can advance to right atrium one side of diaphragm element 30.
The 4th step can be described as regulating bridgeware 12 substantially to obtain suitable therapeutic effect.When back axle stop area 14, bridgeware 12 and propons stop area 16 were constructed as mentioned above, tension force acted on bridgeware 12.Allow implant 10 and relevant range to place preset time, as five seconds or longer.Bicuspid valve and mitral incompetence are observed to be used for the desired therapeutic effect.The tension force that acts on the bridgeware 12 is regulated or readjusted, up to obtaining expected result.When measurement length that reduces when the tension force that obtains expectation or mitral incompetence or degree, bridge stopper 20 allows fixed bridge fitting 12 subsequently.
III. detailed method and implanting device
The implantation step of four big volume descriptions now is explained in more detail, and is included in the multiple instrument and the device that use in the implantation of implant 10 or implant system 22.Illustrative embodiments will be described the Method and kit for of implanting implant 10.Identical or similar Method and kit for can be used to implant implant system 22.
A. form the back axle stop area
1. implanting instrument
Multiple instrument can be used to form back axle stop area 14.For example, can use great cardiac vein (GCV) conduit 40, left atrium (LA) conduit 60, and cutting catheter 80.
Figure 37 A shows an embodiment according to GCV conduit 40 of the present invention.GCV conduit 40 preferably includes: magnetic or ferromagnetic head 42, and it is arranged on catheter shaft 45 far-ends; And cover joint 46, it is arranged on near-end.Catheter shaft 45 comprises first 48 and second portion 50.First 48 is inflexible substantially, so that axle 45 has rotation, and is the structure of entity or braiding.First 48 comprise predetermined length (as, 50 centimetres) so that axle 45 is positioned in the vascular system.Second portion 50 is flexible substantially, can turn in vascular system, for example enters coronary sinus.Second portion 50 comprise predetermined length (as, ten centimetres).The internal diameter of catheter shaft 45 or tube chamber 52 preferably form certain size so that GCV guide line 54 by and make LA guide line 74 by (referring to Figure 39 and 40) extraly.GCV guide line and LA guide line 74 are prebucklings, and all can turn to.GCV conduit 40 preferably includes radio opaque markers thing 56, aligns with LA conduit 60 so that regulate conduit under the guiding of image.
Preferably magnetic or ferromagnetic head 42 are polarized magnetically to attract or to connect the far-end (referring to Figure 37 B and 25) of LA conduit 60.Head 42 comprises side opening 58, and described side opening 58 is formed in the head to allow LA guide line 74 to pass through.As shown in figure 40, left atrium one side 43 of head 42 has the magnetic force that attraction is arranged, and the outside of heart one side 44 of head 42 has the magnetic force of repulsion.Should be understood that when the magnetic force in each conduit when suitable magnetic attraction conforms to, these magnetic force can reverse.Magnetic head 42 preferably includes bullet or tapered tip 55, enters vascular system to allow conduit along track.Stomidium 59 is in top 55, and described stomidium 59 is constructed to allow GCV guide line 54 to pass through.
Figure 38 shows an embodiment of LA conduit 60.Similar with GCV conduit 40, LA conduit 60 preferably includes: magnetic or ferromagnetic head 62, and it is arranged on the far-end of catheter shaft 65; And cover joint 66, it is arranged on near-end.Catheter shaft 65 comprises first 68 and second portion 70.First 68 has certain degree of hardness substantially, so that axle 45 has rotation, and is the structure of entity or braiding.First 68 comprise predetermined length (as, 90 centimetres), be positioned in the structure of vascular system to allow axle 65.Second portion 70 passes fossa ovalis and enters left atrium to allow to turn to for flexible and form anatomic shape substantially.Second portion 70 comprise predetermined length as, ten centimetres.The internal diameter of catheter shaft 65 or tube chamber 72 preferably form certain size, pass through to allow LA guide line 74, and receive guide line 54 from the GCV process extraly.LA conduit 60 comprises radio opaque markers thing 76, aligns with GCV conduit 40 so that regulate conduit 60 under the guiding of image.
Magnetic or ferromagnetic head 62 to LA conduit 60 polarize magnetically to attract or to connect the far-end of GCV conduit 40.As shown in figure 40, distolateral 64 of head 62 is polarized to attract the head 42 of GCV conduit.When the attraction magnetic pole in LA conduit 60 and the GCV conduit 40 alignd, the magnetic force in the head 62 can reverse.Magnetic head 42 preferably includes and is roughly planar top 75, and the pit of the stomach 78 in comprising, the described middle pit of the stomach 78 forms certain sizes so that cutting catheter 80 and LA guide line 74 pass through (referring to Figure 38).
Figure 41 shows cutting catheter 80, and described cutting catheter 80 preferably forms certain size with in the internal diameter or tube chamber 72 that are arranged on LA conduit 60.Alternatively, when LA conduit 60 was removed, cutting catheter 80 was arranged on the LA guide line 74.
Cutting catheter 80 preferably includes: the cutting tip 82 of hollow, and it is arranged on the far-end of catheter shaft 85; And cover joint 86, it is arranged on near-end.Catheter shaft 85 comprises first 88 and second portion 90.First 88 is roughly has certain degree of hardness, has rotation to allow axle 85, and is the structure of entity or braiding.First 88 comprise predetermined length (as, 90 centimetres) so that axle 85 is positioned in the structure and LA conduit of vascular system.Second portion 90 is substantially flexible, operably passes fossa ovalis and enters left atrium allowing.Second portion 90 also comprise predetermined length as, 20 centimetres.The internal diameter 92 of catheter shaft 85 preferably forms certain size, so that LA guide line 74 passes through.Cutting catheter 80 preferably includes the radio opaque markers thing 96 that is arranged on the axle 85, with the radiopaque magnetic head 62 of the relative LA conduit 60 of labelling or the degree of depth of label 76 cuttings.
The cutting of hollow or penetrate top 82 and comprise the far-end 98 of sharpening and preferably form certain size to pass LA conduit 60 and magnetic head 62 is installed (referring to Figure 42 A).Alternatively, shown in Figure 42 B and 42C, cut or penetrate that top 100 and 105 can replace or use in conjunction with the cutting tip 82 of hollow.Three blades 100 of Figure 42 B comprise sharp-pointed distal tip 101 and three cutting blades 102, although can use the blade of arbitrary number.Three blades 100 can be used for avoiding producing the tissue of core, and the cutting tip 82 of hollow can produce the tissue that core is arranged.There is the elimination of core tissue to help to reduce thrombus complication.Can also use the pointed tip guide line 105 shown in Figure 42 C.Pointed end 106 is arranged on the end of guide line to pierce through the wall of left atrium and great cardiac vein.
2. method for implantation
The method that enters vascular system is usually by using introducer known in the art to provide.16F or less hemostatic introducer sheath (not shown) at first are arranged in the superior vena cava (SVC), enter GCV conduit 40 with setting.Alternatively, introducer can also be arranged in the subclavian vein.The 2nd 16F or less hemostatic introducer sheath (not shown) are arranged in the right femoral vein subsequently, enter LA conduit 60 with setting.Enter at SVC and right femoral vein, for example also allow method for implantation to utilize annular guide line.For example, after in the program described, annular guide line is by making LA guide line 74 and pass before the vascular system and then produce, and draws and extends at the engine body exterior of superior vena cava sheath and femoral sheath from body up to annular guide line.LA guide line 74 can be along endovascular path, in this blood vessel the path pass at least the interatrial septum from the superior vena cava sheath to left atrium and pass atrial tissue and pass great cardiac vein and extend from left atrium to femoral sheath.The annular guide line can make the doctor not only can promote but also can spur equipment (referring to Figure 35 A and Figure 36 A) to vascular system in the process of implant procedure.
Selectable step comprises conduit or a plurality of conduit is arranged in the vascular system so that the base line measurement method to be provided.AcuNav
TMIntracardiac ultrasoundcardiogram (ICE) conduit (not shown) or similar devices via right common femoral artery or vein setting with provide by unrestriced example such as the baseline barrier film outside (S-L) separating distance measuring method, atrial walls is separated and the mitral incompetence measuring method measuring method.And the ICE conduit is used to estimate entering of aortic valve, Tricuspid valve, valve of pulmonary trunk, IVC, SVC, pulmonary vein and left atrium.
The GVC conduit is launching near in the great cardiac vein of PM ring subsequently.Under the guiding of image,, for example, advance in the coronary sinus and to great cardiac vein from 0.035 inch the GCV guide line 54 of SVC.Alternatively, can enter the left side aorta from the image of aorta and the left coronary system of shooting with the correlated injection of angiographic catheter to estimate the position of important coronary artery structure.And, great cardiac vein is compared injection so that image and measuring method to be provided.If great cardiac vein is too little, then great cardiac vein enlarges 5 to 12 millimeters air bags, for example, and to the centre of posterior valve leaflet.GCV conduit 40 advances subsequently and passes the position of GCV guide line 54 to the great cardiac vein, for example, and near posterior valve leaflet or back annulus of mitral valve (referring to Figure 23).The position that is used for GCV conduit 40 of expectation also is counted as in the past, and the ventricle angular vein begins roughly 2 to 6 centimetres.When GCV conduit 40 is set up, inject to confirm GCV conduit 40 enough blood flows on every side.If blood flow is lower or do not exist, then GCV conduit 40 is pulled rearward to coronary sinus, when needs GCV conduit.
As shown in figure 24, next, LA conduit 60 advances and passes LA guide line 74 and be arranged in the left atrium.If GCV conduit 40 returns to allow blood flow, then GCV conduit 40 is back in the suitable position now.GCV conduit 40 roughly is rotated subsequently magnetically to align with LA conduit 60.Refer now to Figure 25, preferably under the guiding of image, LA conduit 60 advances and rotates in case of necessity, magnetically is attracted to the magnetic induced head 42 of GCV conduit 40 up to the magnetic induced head 62 of LA conduit 60.The wall of left atrium separates LA conduit 60 and GCV conduit 40 with the vein tissue of great cardiac vein.In case of necessity, magnetic is attached preferably confirms via the image from a plurality of visual angles.
Next, enter tube chamber 115 and be formed on (referring to Figure 26) in the great cardiac vein.Cutting catheter 80 at first places on the LA guide line 74 in the LA conduit 60.Cutting catheter 80 and LA guide line 74 advance up to feeling the resistance of wall of relative left atrium.LA guide line 74 is withdrawn slightly, and when forward pressure acted on cutting catheter 80, cutting catheter 80 was rotated and/or promotes.Under the guiding of image, confirm that cutting catheter 80 penetrates in the great cardiac vein.LA guide line 74 advances in the great cardiac vein subsequently, and further enters in the GCV conduit 40 towards coronary sinus, draws body at the sheath place of cervical region.LA conduit 60 and GCV conduit 40 can be removed now.LA guide line 74 and GCV guide line 54 are located now in position to be used to form the next procedure of wearing every bridgeware 12.
B. form and wear every bridgeware
Since formed back axle stop area 14, wear so every bridgeware 12 be set to from back axle stop area 14 along from after forward direction extend through left atrium and extend to propons stop area 16.
In the described exemplary embodiment of method for implantation, wear every bridgeware 12 and implant via left atrium to the approach of GCV.In this approach, GCV guide line 54 is not used and can removes.Alternatively, equally GCV is described to the left atrium approach.Selectable be used to form to wear every the GCV of bridgeware 12 in trifle IV, describe in detail to the left atrium approach.
For example the bridge stopper of T shape bridge stopper 120 preferably is connected to the bridgeware 12 of predetermined length.Bridgeware 12 is fixed to T shape bridge stopper 120 (referring to Figure 44) by using bridge stopper 150, perhaps by for example binding, weld or glue together or the fixture 121 of its combination in any and so on being connected to T shape bridge stopper 120.Shown in Figure 43 A and 43B, T shape bridge stopper 120 can be symmetric shape or asymmetric shape, can be crooked or straight shape, and preferably include flexible pipe 122, described flexible pipe 122 has predetermined length, as three to eight centimetres, and the certain size of its internal diameter 124 formation is passed to make guide line at least.Pipe 122 preferably braiding forms, and is entity, and polymeric material is stamped in lining.Each end 126 of pipe 122 preferably includes radio opaque markers thing 128 to help the location and T shape bridge stopper 120 is set.Pipe 122 also preferably includes AT end 130 with the protection tube wall.T shape bridge stopper 120 be flexible bending or preformed with the curved shape that meets great cardiac vein or interatrial septum substantially and to around tissue produce less wound.The overall shape of T shape bridge stopper 120 be scheduled to and based on many factors, described factor includes but not limited to the load that the material of length, the bridge stopper of bridge stopper constitutes and waits to act on the bridge stopper.
Reinforce central canal 132 and also include T shape bridge stopper 120.Reinforcing pipe 132 can be arranged on the top of flexible pipe 122, go out as shown, or alternatively, reinforcing pipe 132 can be arranged in the flexible pipe 122.Reinforcing pipe 132 is entity preferably, form but also can weave, and its length is than flexible pipe 122 short a centimetre.Reinforcing central canal 132 has increased hardness for T shape bridge stopper 120 and has helped to prevent that the tube chamber 115 that core is arranged or pierce through that T shape member 120 is passed in great cardiac vein and the left atrial wall from drawing.
The device that selectable T shape member or bridge lock and being used for is connected to bridgeware 12 on T shape bridge lock is described at trifle VI.
As shown in figure 27, T shape bridge stopper 120 (being connected to the front end of bridgeware 12) at first is arranged on the LA guide line 74 or the top.Launching conduit 24 is arranged on the LA guide line 74 (it keeps in position and extends in the great cardiac vein) subsequently and is used to promote T shape bridge stopper 120 and pass Mullins conduit 26 and enter in the right atrium, and pass the interatrial septum from right atrium and enter left atrium, and pass atrial tissue from left atrium and enter the zone near the great cardiac vein of back annulus of mitral valve.LA guide line 74 is withdrawn into the top nearside that launches conduit 24 subsequently.Launch conduit 24 and guide line 74 and be withdrawn into left atrial wall subsequently.T shape bridge stopper 120 and attached bridgeware 12 rest in the great cardiac vein.The length of bridgeware 12 is passed left atrium, passes fossa ovalis, is passed the vascular system extension from back T shape bridge stopper 120, and preferably tail end keeps from the outside near body.Preferably under the guiding of image, the tail end of bridgeware 12 is gently spurred, and wrong make T shape bridge stopper 120 and launches conduit 24 and separate.When confirm separating, bridgeware 12 is gently spurred once more so that T shape bridge stopper 120 relative vein tissues are arranged in the zone of great cardiac vein, and great cardiac vein enter tube chamber 115 above between two parties.Launch conduit 24 and guiding and 74 can be removed (referring to Figure 28) subsequently down.
Wear every bridgeware 12 now in position also along passing left atrium and extend to propons stop area 16 from back axle stop area 14 from back to preceding direction.Bridgeware 12 preferably extends through the structure of vascular system and extends at engine body exterior.
C. form the propons stop area
Since wear in position, next will form propons stop area 16 every bridgeware 12.
In one embodiment, the close end or the tail end of the bridgeware 12 that extends at engine body exterior, be rotated subsequently by or rotation around the propons stopper, for example diaphragm element 30.Preferably, bridgeware 12 passes the diaphragm element 30 in the body outside at close its center, and when the latter launched above fossa ovalis, bridgeware 12 was sent to central point on the diaphragm element 30 with its active force, has reduced reversing or waving of diaphragm element thus.Diaphragm element advances above bridgeware 12 by Mullins conduit 26 with folding structure, and is arranged in the right atrium, docks in the expansion of fossa ovalis place and with the interatrial septum tissue.Bridgeware 12 keeps (referring to Figure 29 and Figure 30) by bridge stopper 20 with tension force subsequently.Propons stopper 20 is attached to or is arranged on the top of bridgeware 12 and advances with diaphragm element 30, and perhaps alternatively, after diaphragm element setting or the expansion, bridge stopper 20 advances to right atrium one side of diaphragm element 30 above bridgeware 12.Alternatively, bridge stopper 20 can also be arranged on the top of LA guide line 74 and be pushed in the right atrium by launching conduit 24.When in right atrium, bridge stopper 20 is attached to or is arranged on the top of bridgeware 12 subsequently, and LA guide line 74 and launch conduit 24 and remove from body fully subsequently.
Figure 44 A shows the sectional view of bridge stopper 170.Bridge stopper 170 is depicted as and is connected to conduit 172, and described conduit 172 has the bridge lock in catheter tip and adjusts bolt 174.In one embodiment, after adjusting was finished, the bridge lock was adjusted bolt 174 and is kept being connected to bridge stopper 170.In selectable embodiment, after adjusting was finished, the bridge lock was adjusted bolt 174 and is kept being connected to bridge stopper 170 to remove.Bridge stopper 170 comprises housing 176, and described housing 176 has and extends axially the tube chamber 178 that passes housing 176.In tube chamber 178, be provided with and be used to keep and regulate bridgeware and closing spring 182 such as anchor clamps or jaw spare 180.Go out as shown, anchor clamps spare 180 is in the position of closure.Anchor clamps top 184 is forced together by the active force that acts on anchor clamps 180 by closing spring 182.In the position of closure, 182 pairs of anchor clamps tops 184 of closing spring apply predetermined active force, and thus bridgeware 12 are applied clamping force to keep the position of bridgeware.Discontinuous stop member 158 provides another obstacle bridgeware 12 kept in position and to be allowed bridgeware 12 to be regulated to cooperate the predetermined interval of stop member.
Alternatively, when anchor clamps 180 closures, conduit 172 is used to reduce the length (increase tension force) of bridgeware 12.Conduit with hook-shaped top 146 is used to hook the ring 156 of exposure.Regulate bolt 174 subsequent section ground spirals to the bridge stopper 170 so that conduit 172 is connected to bridge stopper 170.When conduit 172 was maintained fixed, bridgeware 12 was pulled to active force that bridgeware 12 and relevant discontinuous stop member 158 are applied enough greatly can overcoming the retentivity of anchor clamps 180, thereby allows bridgeware 12 and stop member 158 by anchor clamps top 184.
As at this to the description of bridge stopper 170 and hereinafter to the description of selectable bridge stopper, can comprise and relocate/readjust device (that is, relocating ring 156) so that the function that relocates and/or readjust after implant a few days, several weeks or several years to be provided.To implant relocate/readjust can be after initial implant procedure or before adjusting after carry out.
Figure 44 B is the sectional view of the bridge stopper 170 shown in Figure 44 A, and it shows the control characteristic at the open position bridgeware.Go out as shown, regulate bolt 174 and be depicted as spiral to the tube chamber 178 of bridge lock housing body 176.When adjusting bolt 174 spirals were to bridge stopper 170,186 pairs of anchor clamps 180 in top of regulating bolt 174 applied enough active forces to overcome the active force of closing spring 182.Open to allow the shortening and the elongation of bridgeware 12 on anchor clamps top 184.
Another kind of selectable bridge stopper embodiment is described in trifle V.
D. to the adjusting of bridgeware
When back axle stop area 14, bridgeware 12 and propons stop area 16 were constructed as mentioned above, tension force acted on bridgeware 12, or in the outside of the proximal portion body of bridgeware 12, or in inside, be included in vascular structure and the cardiac structure.At first apply tension to after the bridgeware 12, can make implant 10 and relevant range thereof that preset time is set, as five seconds.In order to obtain the desired therapeutic effect, Bicuspid valve and relevant mitral incompetence thereof are observed subsequently.Act on tension force on the bridgeware 12 and repeat to regulate (as description) along with these steps, up to the result who obtains expectation the embodiment of each bridge stopper.The tension force of bridge stopper 20 fixed bridge fitting 12 expectations subsequently.Bridgeware 12 subsequently with the distance predetermined with bridge stopper 20 (as in to right atrium zero to three centimetres) be cut or separate.The residue length of bridgeware 12 is removed from vascular structure subsequently.Alternatively, bridgeware 12 comprises relocating device or other structure such as hook or ring, is used for to allow to reenter bridge stopper site 14,16 in the future implant system 10 being regulated, being reclaimed or removes.
Alternatively, bridgeware 12 is allowed to extend among the IVC and extends in the femoral vein, perhaps finally extends to the femoral vein inlet point.If the adjusting of bridgeware is necessary or needs, then allow bridgeware to extend among the IVC and extend to bridgeware to be reclaimed after allowing in the femoral vein.
Adjusting program as the bridgeware that just has been described comprises the step that tension force, wait, observation is set and regulates again in case of necessity, the described adjusting program following program of comparing is preferred, promptly comprise adjusting, and the program of while or Real Time Observation and adjusting, apply tension force as working as the doctor, and observe real-time ultrasonoscopy simultaneously and proceed adjusting based on real-time ultrasonoscopy.Because waiting step allows heart and implant through the quiescent period, so waiting step is favourable.This quiescent period allows heart and implant to settle and allows tension force and equipment in back axle stop area and the propons stop area to begin to arrive poised state.When allowing heart and implant that tension force is settled before fixing, relatively when the in sight and real-time adjustment of tonicity of Bicuspid valve was not provided before fixing tension force under the arrangement time situation,, can keep the result of expectation better.
Figure 31 shows the anatomical view of Bicuspid valve malfunction before implant 10 is implanted.As can be seen, two lobe leaves do not engage, and the blood of not expecting that can occur thus from left ventricle to left atrium refluxes.Implant 10 as just described implanted after, implant 10 is used to shorten the minor axis of ring, allows two lobe leaves to engage and reduce the mitral incompetence (referring to Figure 32 and 33) of non-expectation thus.Go out as shown, implant 10 is arranged in the heart, and described implant 10 comprises: bridgeware 12, and it crosses over annulus of mitral valve; Propons stopper 20 and diaphragm element 30, it is on the fossa ovalis or near fossa ovalis; And back axle stopper 18, it is in great cardiac vein.
IV. selectable implantation step
Aforesaid implantation step is because such as patient's age, health and physique size, and the multiple reason of desired therapeutic effect and so on changes.In a selectable embodiment, back T shape bridge stopper 120 (or selectable embodiment) is implanted via the GCV approach, but not via aforesaid left atrium approach.In another selectable embodiment, the sample program of left atrial wall is replaced by the program that pierces through from great cardiac vein to left atrium.
The A.GCV approach
As mentioned above, cutting catheter 60 penetrates into and obtain confirming (referring to Figure 26) in the great cardiac vein under the image guiding.When penetrating when being identified, LA guide line 74 advances in the great cardiac vein and to GCV conduit 40.LA guide line 74 passes GCV conduit 40 and is advanced further, and draws body (preferably at superior vena cava sheath place) up to its end.LA conduit 60 and GCV conduit 40 are removed now.LA guide line 74 and GCV guide line 54 all are being used for the next appropriate location (referring to Figure 35 A) of wearing every the step of bridgeware 12 that forms.At this moment, selectable exchanging pipe 28 advances above LA guide line 74, begin and enter body at arbitrary end of guide line 74, and exchanging pipe 28 is advanced draw body at the other end of guide line 74 up to described exchanging pipe 28 at femoral sheath or superior vena cava sheath place.The effect of this exchanging pipe is to make things convenient for LA guide line 74 and bridgeware 12 to pass through in the program of describing hereinafter, and needn't cut vascular and heart tissue or it is damaged.In preferred embodiment, about 0.040 to 0.060 inch of the ID of exchanging pipe 28, about 0.070 to 0.090 inch of OD, the about 150cm of length; Has slick inside diameter surface; And at least one end, have the soft top that prevents to cause damage, advance thereby exchanging pipe 28 passes vascular system, and can not cause damage tissue.Should be understood that ID, OD and length change according to pending specific program.
In the GCV approach, wear every bridgeware 12 and implant to the left atrium approach via GCV.Predetermined length (as, two meters) bridgeware 12 (having front end and tail end) before front end is connected to, draw the top of the LA guide line 74 of body at superior vena cava sheath and femoral sheath.In said embodiment, LA guide line 74 is as annular guide line, thereby the permission bridgeware is gently spurred or is retracted to or pass through to the vascular structure of small part and enters heart chamber.The vascular path of bridgeware is passed coronary sinus from the superior vena cava sheath and is extended to the zone of great cardiac vein near the back annulus of mitral valve, and pass atrial tissue from great cardiac vein and extend to the left atrium, and pass the interatrial septum from left atrium and extend to the right atrium, and extend to femoral sheath from right atrium.
Shown in Figure 34 A to 34D, aluminium hydraulic pressed connecting pipe or adapter 800 are used for bridgeware 12 is connected at least one end of LA guide line 74.Figure 34 A shows the aluminium hydraulic pressed connecting pipe 800 that preferably has outer protection shell 802 and interior pipe 04.Outer protection shell 802 is preferably made the pliability that prevents from aluminium hydraulic pressed connecting pipe is caused damage to provide by polymeric material, though but can also use the material of other crimping.In pipe 804 make by ductility such as ductile metal or toughness material, to allow crimp bridgeware 12 and guide line 74 are kept in position.The end 806 of aluminium hydraulic pressed connecting pipe curves inwardly slightly, moves to help aluminium hydraulic pressed connecting pipe when aluminium hydraulic pressed connecting pipe 800 moves through vascular system.Should be understood that aluminium hydraulic pressed connecting pipe can only comprise the single pipe of being made by ductility or toughness material.
Shown in Figure 35 B, LA guide line 74 is gently withdrawn, thereby makes bridgeware 12 and then pass vascular structure.If use exchanging pipe 28 (shown in Figure 35 A and Figure 35 B) arbitrarily, then LA guide line 74 passes the tube chamber withdrawal of exchanging pipe 28, and can not damage tissue.LA guide line 74 is removed from the outside of body fully at sheath of femoral vein, and makes bridgeware 12 extend (preferably at femoral sheath), pass vascular structure, also draw at the superior vena cava sheath once more from engine body exterior.LA guide line 74 is removed with bridgeware 12 by cutting or be separated in aluminium hydraulic pressed connecting pipe 800 places or near the bridgeware aluminium hydraulic pressed connecting pipe 800 12 subsequently.
Back axle stopper such as T shape bridge stopper 120 preferably is connected to from the tail end of the bridgeware 12 of superior vena cava sheath extension.T shape bridge stopper 120 is arranged on the GCV guide line 54 or the top subsequently.Launching conduit 24 is arranged on the GCV guide line 54 or top and be used to make T shape bridge stopper 120 and bridgeware 12 to advance or promote it and pass right atrium, pass coronary sinus and enter in the great cardiac vein subsequently.If use selectable exchanging pipe 28, then exchanging pipe is with bridgeware 12 or gently withdraw in its front portion slightly (referring to Figure 36 A and 36B).Selectively, bridgeware 12 or pull out so that T shape bridge stopper 120 and bridgeware 12 advance in the appropriate location the great cardiac vein from the femoral vein zone separately or in conjunction with launching conduit 24.GCV guide line 54 is withdrawn subsequently and T shape bridge stopper 120 is separated with expansion conduit 24 with GCV guide line 54.Preferably under the guiding of image, and when separating when being identified, bridgeware 12 gently spurred with T shape bridge stopper 120 is provided with dock with vein tissue in great cardiac vein and above GCV enters tube chamber 115 between two parties.Launching conduit 24 and selectable exchanging pipe 28 is removed subsequently.
T shape bridge stopper 120 and attached bridgeware 12 rest in the great cardiac vein.The length of bridgeware 12 extends through left atrium, passes fossa ovalis, passes vascular system from back T shape bridge stopper 120, and preferably keeps and can enter from the outside at body.Bridgeware 12 prepares to form the next procedure of propons stop area 16 now, as mentioned above, and shown in Figure 28 to 30.
B. pierce through program
In described selectable embodiment, the program of tube chamber coring is replaced from left atrium to great cardiac vein the passage the pointed tip guide line in the i.e. great cardiac vein is used to produce from great cardiac vein to left atrium by following program.The selectable embodiment of both magnetic heads of GCV conduit 40 and LA conduit 60 preferably is used to described program.
Figure 45 A and Figure 45 B show the polar embodiment of end-to-side that is used for GCV conduit magnetic head 200 and LA conduit magnetic head 210.Alternatively, also can use the side to lateral polarity.GCV conduit magnetic head 200 can be kept the polarity of end-to-side and the polarity identical construction of end to end, and LA conduit magnetic head 215 be depicted as for the polar embodiment in side to side rotated substantially 90 the degree (referring to Figure 46).
Shown in Figure 45 B, GCV conduit magnetic head 200 comprises the double lumen structure.Navigation guide spool chamber 202 permission GCV conduits 54 extend through the taper or the bullet shaped end 204 of head 200, to handle GCV conduit 400 to suitable position.The second side opening tube chamber that radially bends 206 allows pointed tip guide line 105 (or three blades 100) to extend through head 200 and guides in pointed tip guide line 105 to the LA conduit magnetic heads 210.LA conduit magnetic head 210 comprises funnelform end 212 and guide wire lumen 214 (referring to Figure 45 C).Funnelform end 212 guides pointed end guide line 105 to enter tube chamber 214 and enter LA catheter shaft 65.
Figure 46 shows the selectable embodiment of the LA conduit magnetic head 215 that uses the polar embodiment in side to side.Head 215 has GCV conduit magnetic head 42 identical construction that illustrate with Figure 39 and Figure 40 and describe in trifle III.Head 215 is included in the navigation guide spool chamber 216 at taper or 218 places, bullet shaped end, and side opening 220.Side opening 220 makes pointed end guide line 105 (or three blades 100) from GCV conduit 40 to LA conduits, 60 funnels and guide guide line 105 to enter the LA catheter shaft 65.
In use, GCV conduit 40 and LA conduit 60 all advance in great cardiac vein and the left atrium as mentioned above.GCV conduit 40 and LA conduit 60 comprise selectable magnetic induced head as described respectively.Shown in Figure 45 A and Figure 45 B, the guide line 105 of pointed tip passes the inwall that GCV conduit 40 advances to great cardiac vein.The guide line 105 of pointed tip is advanced further, and punctures or pierce through the wall of great cardiac vein and left atrium up to guide line 105, and enters the funnelform end 212 in the LA catheter head 210.The guide line 105 of pointed tip is advanced further up to guide line 105 draws from the near-end of LA conduit 60.Now GCV conduit 40 and LA conduit 60 are all removed, thereby the guide line 105 of GCV guide line 54 and pointed tip is stayed in position.Back T shape bridge stopper 120 is implanted via the GCV approach, as mentioned above and shown in Figure 35 A to 36B.
The embodiment of V. selectable bridge stopper
Can use the selectable embodiment of bridge stopper, and be described at this.The bridge stopper is used for locating fixed bridge fitting 12 at back axle stop area 14 or propons stop area 16 or both.The selectable embodiment that should be understood that the bridge stopper can comprise discrete component, maybe can comprise a plurality of elements.And the characteristic of the selectable embodiment of bridge stopper is that bridgeware is regulated with only tension or only release, or tension and release.
Figure 47 shows the perspective view of selectable embodiment of the implant system 10 of the type shown in Figure 10 A to Figure 10 D.The implant system 10 of Figure 47 shows the use of the ring 156 that is used to allow exposure that implant system is regulated or removed.Go out as shown, the conduit with hook-shaped top 146 can be used for hooking the ring 156 of exposure.Radio opaque markers thing 160 can be with so that catch or hook the ring 156 of exposure.Bridgeware 12 also is depicted as the usage that comprises in conjunction with propons stopper 170 discontinuous stop member 158 together.
Figure 48 is the perspective view according to the selectable embodiment of bridge stopper 390 of the present invention.Selectable bridge stopper 390 preferably includes dentation tape 392 and bridge stopper housing 394.Dentation tape 392 comprises all or part of bridgeware 12 and comprises the isolated tooth 396 of at least one row that described tooth 396 is provided with along at least one edge of tape.Housing at one end comprises locking circle 398.Locking circle 398 comprises rectangular aperture 400, thereby when locking circle during at open position, allows dentation tape 392 to move freely (referring to Figure 48); And when locking circle during at locked position, soldered tooth 398 (referring to Figure 49).Another bridgeware or stitched type material 402 can be connected to dentation tape 492, thereby allow housing 494 and locking circle 398 to be arranged on the dentation tape.
In use, bridge stopper 390 allows to open position the length of the bridgeware that comprises dentation tape 392 to be regulated (referring to Figure 48) by rotary locking circle 398.The function that the conduit (not shown) desirably is used to catch locking circle 398 and is used to provide rotation.When locking circle during at open position, tape 392 freely moves, the length of regulating bridgeware 12 thus.When forming the tension force of expectation, conduit is used for rotary locking circle 398 90 degree once more, keeps (referring to Figure 49) in position with soldered tooth 396 and with tape 392.
Figure 50 is the perspective view according to the selectable embodiment of bridge stopper 410 of the present invention.Selectable bridge stopper 410 preferably includes adjusting ring or nut 414, locking circle or nut 416 and thread spindle 412, and described thread spindle 412 comprises all or part of bridgeware 12.Go out as shown, adjusting nut 414 and locking nut 416 comprise the characteristic of being convenient to rotate.Adjusting nut 414 is depicted as has bar or a plurality of bar 418, and described bar 418 radially extends from nut.The periphery that locking nut 416 is shown in nut has one or more recesses 420.These revolving properties allow conduit to be arranged on thread spindle and adjusting nut 414 and locking nut 416 tops, with the locking nut 416 that gets loose, regulate the position of adjusting nut 414, regulating action is in the tension force of bridgeware 12 thus, and retightens locking nut 416 subsequently.Another bridgeware or suture material 402 can be connected to thread spindle 412, to allow adjusting nut 414 and locking nut 416 to be arranged on the thread spindle.
Alternatively, can use the single nut 422 (referring to Figure 51) that has such as nylon wire from the locking screw thread.Single nut has the advantage of the quantity that has reduced adjusting bridgeware 12 needed steps.
Figure 52 is the perspective view according to the selectable embodiment of bridge stopper 430 of the present invention.Selectable bridge stopper 430 preferably includes perforation tape 432 and bridge stopper housing 434.Perforation tape 432 comprises all or part of bridgeware 12 and comprises at least one row's spaced perforations 436 that described perforation 436 is along the length setting of tape.Another bridgeware or suture material 402 can be connected to perforation tape 432, thereby allow bridge stopper housing 434 to be arranged on the perforation tape.
With reference to Figure 53 and Figure 54, housing comprises the locking spring 438 that is arranged in the recess 440.Housing 434 also comprises protuberance or a plurality of protuberance 442, thereby allows connecting duct or regulate conduit 444.Go out as shown, conduit 444 comprises that linking arm or a plurality of linking arm 446 are to be connected to housing protuberance 442 (referring to Figure 54).This connection between housing and adjusting conduit keeps the position of bridge stopper housing 434, thereby allows perforation tape 432 is regulated to increase or to reduce the length of bridgeware.
Figure 53 shows the bridge stopper 430 in the locking structure.Locking spring 438 is depicted as in the perforation 436 that extends in the tape 432.In order to regulate bridgeware, conduit 444 at first is connected to bridge stopper housing protuberance 442 by engaging conduit linking arm 446.Shown in Figure 54, regulate conduit 444 and be connected to bridge stopper 430.In described adjusting structure, perforation tape 432 can be pulled or promote, thereby makes locking spring 438 temporarily go out and enter the empty recess 440 from 436 bendings of boring a hole.Perforation 436 has circular edge, thereby when tape 432 is regulated, is convenient to locking spring 438 and goes out from 436 bendings of boring a hole.Tape is adjusted to locking spring 438 and is bent in the perforation 436 some place with the position of keeping bridgeware 12 once more.
Figure 55 and Figure 56 show the selectable embodiment according to bridge stopper 450 of the present invention.Selectable bridge stopper 450 preferably includes unidirectional dentation tape 452 and bridge stopper housing 454, and described bridge stopper housing 454 has the tube chamber 456 that radially extends through housing.Unidirectional dentation tape 452 comprises all or part of bridgeware 12 and comprises the isolated tooth 458 of at least one row that described tooth 458 is provided with along at least one edge of tape.In one embodiment, tooth 458 tilts to allow that tape 452 is carried out unidirectional adjusting (referring to Figure 55).In the tube chamber 456 of housing, be provided with the device that is used for unidirectional dentation tape 452 is remained on the appropriate location.Shown in Figure 55 and Figure 56, protuberance 460 grades are arranged on the tube chamber 456 interior teeth 458 with engage angled of housing, and allow tooth along a direction, but are not passing through of twocouese.In one embodiment, the tooth 458 of inclination is roughly flexible, and that protuberance 460 is roughly is inflexible, thereby allows housing to promote above tooth 458 along a direction, and resists mobile along opposite direction housing.In selectable embodiment, the tooth 458 of inclination is roughly inflexible, and that protuberance 460 is roughly is flexible.Should be understood that bridge stopper 450 can be modified to comprises that substantially flexible tooth 458 and protuberance 460 move to allow dentation tape 452 two-wayly.
Figure 57 A to Figure 58 C shows the another kind of selectable embodiment according to bridge stopper 470 of the present invention.Figure 57 A to 57C shows the bridge stopper 470 of the bridgeware 12 in the structure that is included in restriction.Figure 58 A to 58C shows the bridge stopper 470 of the bridgeware 12 in the structure that is included in not restriction.Selectable bridge stopper 470 preferably includes housing 472, though described housing 472 is nonessential, can be tubulose; Described housing comprises top side 474, bottom side 476, inner surface 478 and outer surface 480.In housing, be provided with from the top side 474 or extend in the bottom side 476 or near the wall or the inclined-plane 482 of the inclination of the inner surface it 478 near it.Groove or slit 484 are arranged in the inclined-plane 482, and described groove or slit 484 extend to the circular open 486 of biasing.Slit 484 is arranged near 474 places, top side or its and extends to and is arranged on 476 places, bottom side or near the circular open 486 it.
Figure 57 A to Figure 57 C shows at the bridgeware 12 of restriction site and relevant discontinuous stop member 158.Go out as shown, slit 484 forms certain size and moves in slit only to allow bridgeware 12.Allow inclined-plane 482 to help to make stop member 158 and bridgeware 12 to move in the slit 484 and along the tension force that acts on bridgeware 12 to (towards housing top side 474) upward, go out as shown to restriction site.Stop member 158 prevent bridgeware 12 basically along upward to move.
Figure 58 A to 58C shows at the not bridgeware 12 and relevant discontinuous stop member 158 of restriction site.In described structure, can regulate the length (tension force) of bridgeware 12.Go out as shown, circular open 486 forms certain size and is constructed to allow comprise that the bridgeware 12 of discontinuous stop member 158 is by opening 486.Should be understood that opening can adopt any shape relevant with the shape of stop member 158.The tension force that (towards housing bottom side 476) acts on bridgeware 12 allows inclined-plane 482 to help to make stop member 158 and bridgeware 12 482 to move down (that is, shift out slit 484 and enter in the opening 486) along the inclined-plane and to restriction site not, goes out as shown.Stop member 158 (with bridgeware 12) can freely pass through circular open 486.Should be understood that bridgeware 12 and discontinuous stop member 158 can comprise discrete component, maybe can comprise the single stop member that is connected to bridgeware.
Figure 59 A to Figure 60 C shows the selectable embodiment of bridge stopper 970.Selectable bridge stopper 970 preferably includes the additament of revolving door 988.Revolving door 988 provides a kind of mechanism easily to reset to allow bridgeware 12 and discontinuous stop member 158, thereby allows to regulate in the process of program.Figure 59 A to Figure 59 C shows the bridge stopper 970 that is included in the bridgeware 12 in the restriction structure, and Figure 60 A to Figure 60 C shows the bridge stopper 970 that is included in bridgeware 12 in the restriction structure.
The revolving door 988 that is arranged in the housing 972 comprises slit 989, and described slit 989 forms certain size and is constructed to be equipped with the length and the width of the slit 984 in inclined-plane 982.Revolving door 988 is with hinged or be connected to housing 972 or inclined-plane 982 rotatably.Go out as shown, revolving door 988 comprises pin or protuberance 990, and described pin or protuberance 990 are arranged in the aperture 991 to allow door 988 to pivot or rotation around protuberance 990.Aperture 991 is arranged in the housing 972 to allow the slit 984 of revolving door 988 in inclined-plane 982 to engage the position or near the pivot or the rotation it of the circular open 986 of biasing.Revolving door 988 can remain on the position (shown in Figure 59 A to 59C) of restriction by spring 994, perhaps can allow door freely to move, and it moves the tension force that depends on bridgeware 12 and discontinuous stop member 158.Reset the outer rim 992 that ring 993 is connected to revolving door 988, the described ring 3 that resets has radio opaque markers thing 160.
Figure 59 A to Figure 59 C shows at the bridgeware 12 of restriction site and relevant discontinuous stop member 158.Go out as shown, slit 984 and the slit in the door 988 989 in the inclined-plane 982 form certain size, move in each slit only to allow bridgeware 12.Allow door 988 to help to make stop member 158 and bridgeware 12 to move in the slit 988 (with slit 984) and along the tension force that acts on bridgeware 12 to (towards housing top side 974) upward, go out as shown to restriction site.Stop member 158 prevent bridgeware 12 basically along upward to move.
Figure 60 A to Figure 60 C shows at the not bridgeware 12 and relevant discontinuous stop member 158 of restriction site.In described structure, can regulate the length (tension force) of bridgeware 12.Go out as shown, circular open 986 forms certain size and is constructed to allow comprise that the bridgeware 12 of discontinuous stop member 158 is by opening 986.Should be understood that opening can adopt any shape relevant with the shape of stop member 158.Under the help of conduit (not shown), reset ring 993 (towards housing bottom side 976) pulling in a downward direction to drive bridgeware 12 and discontinuous stop member 158 downwards (promptly along revolving door 988, come out from slit 989) and enter the circular open 986 of biasing and to the not position of restriction that is used to regulate, go out as shown.Stop member 158 (with bridgeware 12) can freely pass through circular open 986.Should be understood that bridgeware 12 and discontinuous stop member 158 can comprise discrete component, maybe can comprise being connected to for example single stop member of bridgeware.
Figure 61 is the perspective view according to another selectable embodiment of bridge stopper 500 of the present invention.Selectable slidably bridge stopper 500 preferably includes dentation tape 502 and bridge stopper slider part 504.Dentation tape 502 comprises all or part of bridgeware 12 and comprises the isolated tooth 506 of at least one row that described tooth 506 is provided with along at least one edge of tape.Go out as shown, dentation tape 502 comprises that one comes isolated tooth 506 on each side of tape.Tooth 506 illustrates and is set to not staggered sawtooth pattern.In one embodiment, dentation tape 502 has about 0.060 inch height H 1, yet height H 1 can change.Slider part 504 comprises re-entrant part 508 and engaging member 510.
Figure 62 and Figure 63 show re-entrant part 508 (Figure 63 shows re-entrant part with sectional view).Go out as shown, re-entrant part can be roughly tubulose and comprise the tube chamber 512 that extends through described re-entrant part.Groove or passage 520 are arranged on the outer surface 518 substantially, the centre of first end 514 and second end 516, and described groove or passage 520 extend around outer surface 518.Recess or recessed 522 is arranged in the passage 520.What expect is that passage 520 comprises four recesses 522, and described recess 522 is set to be spaced apart from each other with 90 degree.Re-entrant part 508 can also comprise and reverse pin or a plurality of pin 524 that reverses that the described pin 524 that reverses radially extends from outer surface 518.
Be provided with axial symmetry groove 526 (specifically referring to Figure 63) in the tube chamber 512 of re-entrant part 508.Groove 526 is not to extend around tube chamber 512 internal diameters fully.At least one bridgeware passage 528, and the length of two parallel channels extending flute parts 508 desirably.
Figure 64 shows engaging member 510, and described engaging member 510 rotatably partly is arranged on re-entrant part 508 tops and passes re-entrant part 508.Engaging member 510 comprises: base portion 530; At least one finger piece 532, it extends from described base portion 530; And base portion extension 534.Base portion 530 and base portion extension comprise the passage 536 that extends through it.At least one finger piece desirably comprises four finger pieces 532, and each recess 522 on the re-entrant part 508 has a finger piece.Top at each finger piece 532 can be provided with protuberance 538, and described protuberance 538 and recess 522 cooperate with as brake, center on rotatablely moving of re-entrant part 508 thereby limit engaging member 510.
In use, engaging member 510 is arranged on re-entrant part 508 tops, shown in Figure 61.Punctual when the passage in the re-entrant part 508 528 with 536 pairs in passage in the engaging member, allow dentation tape 502 is regulated (prolonging or shorten bridgeware).In this adjusting structure (referring to Figure 65), the isolated tooth 506 on the dentation tape 502 does not limit by the groove 526 that is arranged in the re-entrant part 508, and tape 502 freely slides in bridge stopper 500.Braking characteristic (recess 522 and protuberance 538) provides predetermined adjusting position and restriction site, thereby makes bridge stopper 500 regulate structure and limit between the structure and change more simply.
When obtaining to act on the tension force of bridgeware 12 expectations, the conduit (referring to Figure 67) that has a torque tool 540 at its far-end is used for or rotates re-entrant part 508 along clockwise direction or in the counterclockwise direction, and keep the dentation tape position of (with engaging member 510), thereby be bonded on the isolated tooth 306 in the coupling groove 526 of re-entrant part 508, limited dentation tape 502 (referring to Figure 66) thus.And braking characteristic (recess 522 and protuberance 538) provides predetermined restriction site, thereby bridge stopper 500 is maintained in the described restriction structure.
Shown in Figure 67, torque tool 540 comprises external torque device 542 and inner torquer 544.Outside torque tool 542 comprises that at its far-end 548 at least one recess 546 reverses pin or a plurality of pin 524 that reverses to be bonded on the re-entrant part 508.Inner torquer 544 (being arranged in the external torque device 542) comprises passage 550, and described passage 550 forms certain size and is constructed to allow the dentation tape to extend in inner torquer 544.
In the selectable embodiment of bridge stopper 500 slidably, the bridge stopper 560 (referring to Figure 68) of screw preferably includes dentation tape 562 and bridge stopper screw parts 564.Dentation tape 562 comprises all or part of bridgeware 12 and comprises the isolated tooth 566 of at least one row that described tooth 566 is provided with along at least one edge of tape.Go out as shown, dentation tape 562 comprises the isolated tooth 566 of a row on each side of tape.Tooth 566 illustrates the sawtooth pattern that is set to interlock.In one embodiment, dentation tape 562 has about 0.060 inch height H 2, yet height H 2 can change.Screw parts 564 comprise screwed part 568 and base element 570.
Figure 69 and Figure 70 show screwed part 568 (Figure 70 shows screwed part with sectional view).Go out as shown, screwed part is roughly tubulose and comprises the tube chamber 572 that extends through described screwed part.Groove or passage 580 are arranged on the outer surface 578 substantially, the centre of first end 574 and second end 576, and described groove and passage 580 extend around outer surface 578.Screwed part 568 can also comprise pin or a plurality of pin 584, and described pin 584 radially extends from outer surface 578.
In the tube chamber 572 of screwed part 578, be provided with helical form (screw thread) groove 586 (specifically shown in Figure 70).Groove 586 extends around the internal diameter of tube chamber 572 fully.
Figure 71 shows base element 570, and described base element 570 rotatably partly is arranged on screwed part 568 tops and passes screwed part 568.Base element 570 comprises base portion or cover joint 590 and base portion extension 594.Cover joint 590 and base portion extension 594 comprise the passage 596 that extends through it.One or more holes 598 are arranged in the cover joint 590, and form certain size and be constructed to banking pin 600.Two holes 598 shown in Figure 71.Screwed part 568 is connected to after the base element 570, sells 600 patchholes 598.Hole 598 is set to allow the pin 600 that inserts to be arranged in the passage 580 on the screwed part 568.Pin 600 remains on base element 570 on the screwed part 568, and allows screwed part 568 relative base element 570 to rotate.
In use, base element 570 is arranged on re-entrant part 568 tops, shown in Figure 68.When bridgeware 12 was regulated, the conduit (shown in Figure 67 and described above) that has a torque tool 540 at its far-end was used for or rotates screwed part 568 along clockwise direction or in the counterclockwise direction.The helical groove 586 of screwed part 568 engages the tooth 566 of dentation tape 562, thereby makes the dentation tape pass bridge stopper 560 spirally, and it prolongs or shorten dentation tape 562 (bridgeware) again.When the tension force of the bridgeware that obtains expectation, torque tool 540 is removed.Each embodiment that should be understood that the bridge stopper can be configured to have the bridge fixture construction when static state, allow bridgeware to move freely necessary forward actuation force in the bridge stopper or around it with needs.When obtaining the tension force of expection in bridgeware, actuation force can be removed, and thus the bridge stopper is back to its static state, and the bridge stopper is fixed to bridgeware.Alternatively, the bridge stopper also is constructed to allow moving freely of bridgeware 12 in static state, needs thus bridgeware is fixed on the needed forward bed knife that remains on the bridge stopper in the bridge stopper.
Preferably, the bridge fixed characteristic is clear via the feedback of sense of touch or fluorescence.Fixed function is locking and opening repeatedly preferably, allows thus bridgeware is regulated again.The material of bridge stopper still desirably is radiopaque or has made up radiopaque characteristic and be provided with fluorescence can make the bridge stopper.
As mentioned above, bridgeware 12 can comprise discrete component, maybe can comprise a plurality of elements.In multiple above-mentioned embodiment, bridgeware comprises a plurality of elements.The dentation tape 502 that Figure 72 shows bridge stopper 500 comprises the example of part bridgeware 12.Go out as shown, dentation tape 502 for example, extends through bridge stopper 500 and passes diaphragm element 30, and be connected to the segment of bridgeware 12 subsequently.Dentation tape 502 can by bind, gummed, crimping, welding or single piece of material processed be connected to bridgeware 12, shown as limiting examples.
In selectable embodiment, dentation tape 502 for example can comprise the bridgeware of one, shown in Figure 73.Go out as shown, dentation tape 502 extends through bridge stopper 500 and passes diaphragm element 30, and continues to pass through left atrium and the back axle stop area 14 that arrives, and wherein dentation tape 502 is connected to back axle stopper 18.
The segment of bridgeware 12 can extend to right atrium, to allow reclaiming implant system or adjusting bridgeware, shown in Figure 72.Go out as shown, comprise that the segment of bridgeware of the ring 156 of exposure is extended from dentation tape 502.Radio opaque markers thing 160 is used so that catch or hook the ring 156 of exposure.
In selectable embodiment, dentation tape 502 comprises the hook of one or encircles 303, to allow reclaiming implant system or adjusting bridgeware, shown in Figure 72.Can use radio opaque markers thing 160 so that catch or hook the ring 303 of exposure.
The embodiment of the selectable T shape of VI bridge stopper
Can use the selectable embodiment of T shape bridge stopper, and be described at this.T shape bridge stopper can be used for locating fixed bridge fitting 12 (the perhaps embodiment of selectable bridgeware) at propons stop area 16 or back axle stop area 14 or both.The selectable embodiment that should be understood that T shape bridge stopper can comprise discrete component, maybe can also comprise a plurality of elements, shown in Figure 43 A and Figure 43 B and describe.The selectable embodiment that it is to be further understood that T shape bridge arrestment can be symmetric, perhaps can also be asymmetric shape.And the selectable embodiment of T shape bridge stopper has characteristic that bridgeware is regulated with only fastening, perhaps gets loose and fastening.
Figure 74 is the perspective view according to the selectable embodiment of T shape bridge stopper 680 of the present invention.Selectable T shape bridge stopper 680 preferably includes outside screw male member 682, and described outside screw male member 682 partly is inserted in the inside thread female member 684.Male member 682 comprises tube 686, described tube 686 is from being arranged on the middle part that end 688 in the female member extends to about male member 682, though the middle part of tube 686 extend past male members comprises the whole length of extending male member 682, perhaps can extend not middle part to male member.Aperture 690 is arranged in the male member 682 and extends to tube 686 from the outer surface 692 of male member.
In use, T shape bridge stopper 680 allow by or clockwise direction or counterclockwise rotate the length that female member is regulated bridgeware 12.Shown in Figure 74, conduit 694 is used to be connected to the end 696 of female member 684, so that the rotation of female member to be provided.Bridgeware 12 is fixed on 698 places in the female member 684, thereby the rotation of female member 684 makes the whole length of T shape bridge stopper 680 extend or shrinks the length of regulating bridgeware 12 thus.T shape bridge stopper 680 is depicted as in the tube chamber that is arranged on blood vessel 700.Bridgeware 12 extends through the tube 686 of male member from fixing point 698, passes aperture 690 subsequently, and passes blood vessel wall 702.Bridgeware 12 penetrates to pass blood vessel wall and pass aperture 690 702 male member 682 is stopped the rotation, and allows female member 684 rotations thus and the length of adjusting bridgeware 12.T shape bridge stopper 680 is depicted as in the tube chamber that is arranged on vascular 700.Bridgeware 12 extends through the tube 686 of male member from fixing point 698, passes aperture 690 then, and passes the catheter wall at 702 places.Passing of the catheter wall at 12 pairs 702 places of bridgeware and aperture 690 stopped the rotation male member 682, allows female member 684 rotations to regulate the length of bridgeware 12 thus.Figure 75 is the perspective view according to the selectable embodiment of T shape bridge stopper 710 of the present invention.Selectable T shape bridge stopper 710 preferably includes: ratchet mechanism 712, and it has first member 720 and second member 722 (as, the mechanism of ball pen type); And compression spring 714, itself and ratchet mechanism 712 and operate; Ratchet mechanism 712 and compression spring 714 all are arranged in the tubular element 716.Aperture 718 is arranged on the centre (although also be feasible along other position of the length of bridge stopper) of tubular element 716 substantially, and described aperture 718 allows bridgewares 12 to pass the wall of tubular element 716 and be connected to ratchet mechanism 712.
In use, T shape bridge stopper 710 allows the length of regulating bridgeware 12 by the operation of ratchet mechanism 712.Shown in Figure 75, conduit 694 is used to be connected to first member 720 of ratchet mechanism 712, providing axial force to ratchet mechanism, and rotates second member 722 of ratchet mechanism thus.When first end 720 promotes by conduit 694, allow the discontinuous segment of bridgeware 12 to pass aperture 718 and provide or withdraw.Conduit 694 also can and reset any tension force that acts on bridgeware 12 by 712 releases of rotation ratchet mechanism.The rotation of second member 722 makes bridgeware 12 twine the length of regulating bridgeware 12 thus around second member 722.Shown in Figure 74, T shape bridge stopper 710 is arranged in the blood vessel or organ walls setting relatively.Bridgeware 12 penetration rate of blood tube walls and penetrate aperture 718 tubular element 716 is stopped the rotation allow 722 rotations of second member and the length of regulating bridgeware 12 thus.
Figure 76 is the perspective view according to the selectable embodiment of T shape bridge stopper 730 of the present invention.Selectable T shape bridge stopper 730 preferably includes: tubular element 732, and it has aperture 734; And anchor clamps 736, it is arranged in the tubular element 732.Aperture 734 is arranged on the centre (although also be feasible along other position of the length of bridge stopper) of tubular element 732 substantially, and anchor clamps 736 be arranged on substantially tubular element first end 738 near.In tubular element 732, near second end 740, bridgeware is connected to tubular element at fixing point 742 places substantially.
In use, T shape bridge stopper 730 allows by by having the length (increase tension force) that ring 744 that conduit such as the adjusting device on hook-shaped top 746 spurs the exposure of bridgeware 12 shortens bridgeware 12.Should be understood that another kind is connected to the device of the exposed ends of bridgeware 12, also expects such as anchor clamps, ring or magnetics.Shown in Figure 76, conduit 746 is used to hook and spur subsequently the ring 744 of exposure.By the ring that pulling exposes, anchor clamps 736 are passed in a lower limb pulling of bridgeware 12.Pulling force must be greater than the chucking power of anchor clamps 736, thereby when the ring 744 that exposes discharges, the position of in anchor clamps, keeping bridgeware.Anchor clamps 736 comprise zigzag jaw 748, thereby the performance that improves anchor clamps 736 is passed zigzag jaw 748 and is improved tension force to allow pulling bridgeware 12, bridgeware 12 is not retracted passes anchor clamps 736 (this will cause tensile reduction) but do not allow to act on tension force on the bridgeware 12.
Figure 77 is the perspective view according to the selectable embodiment of T shape bridge stopper 750 of the present invention.Selectable T shape bridge stopper 750 preferably includes tubular element 752, and described tubular element 752 comprises slit 754.Slit 754 is arranged in the middle of the tubular element 752 substantially, although also be feasible along other position of the length of bridge stopper.
In use, T shape bridge stopper 750 allows by by having the length (increase tension force) that ring 756 that adjusting conduit such as hook-shaped top 146 spurs the exposure of bridgeware 12 shortens bridgeware 12.Shown in Figure 77, in said embodiment, bridgeware 12 comprises discontinuous pearl or stop member 158.Conduit 146 is used to hook and spur subsequently the ring 156 of exposure.By the ring that pulling exposes, comprise that slit 754 is passed in bridgeware 12 pullings of discontinuous stop member 158.Slit 754 allows pearl to be pulled in the tubular element 752, but can not pull out from tubular element 752.Slit 754 comprises tablet 760 (as the sheet in duckbill valve), helping the keeping tension force that acts on bridgeware 12, and prevents that discontinuous stop member 158 from pulling out from tubular element 752 by the tension force that acts on bridgeware 12.The length that discontinuous stop member 158 is set to and is scheduled to (as, approximately 2mm is to about 5mm) be spaced apart from each other, with the contraction in length bridgeware of permission to be scheduled to.
VII. the embodiment of selectable bridgeware
The embodiment of selectable bridgeware can be used and be described at this.Bridgeware is used to propons stop area 16 is fixed to back axle stop area 14.The selectable embodiment that should be understood that bridgeware can comprise discrete component, maybe can also comprise a plurality of elements.
Figure 78 is the perspective view according to the selectable embodiment of the implant system 10 with bridgeware 770 of the present invention.Bridgeware 770 with first end 772 and second end 774 is depicted as and extends through diaphragm element 30 and be connected to back axle stopper 18.Bridgeware also is connected to diaphragm element 30.Bridgeware 770 desirably comprises the tape of the material of ductility such as rustless steel (that is, can molding, bending or be drawn out).By reversing bridgeware 770 what back axle stop area 14 and/or propons stop area 16 were finished, bridgeware shortens or prolongs, and because the bending of bridgeware, bridgeware remains on the length of expectation.Regulate the required twisting resistance of bridgeware 770 greater than the tension force that acts on bridgeware.Reverse and to finish by regulating the conduit (not shown).
Figure 79 is the perspective view according to the another kind of selectable embodiment of the implant system 10 with bridgeware 780 of the present invention.Bridgeware 780 is depicted as and extends through diaphragm element 30 and be connected to back axle stopper 18.Bridgeware can also be connected to diaphragm element 30.Bridgeware 780 desirably comprises at least one ring of bridgeware.First end 782 of bridgeware 780 can be connected to diaphragm element 30, or selectively is connected to propons stopper 20, or selectively is connected to grommet 32.Since first end 782, bridgeware is around hook or holder 784, and described hook or holder 784 are connected to back axle stopper 18 and extend subsequently and get back to and pass diaphragm element 30.Annular bridgeware 780 makes the length doubles of bridgeware and since described 1/2 unit that has improved than 1 unit the pulling ratio, with regard to permission implant system 10 carried out meticulousr adjusting like this.
Figure 80 A is the perspective view according to the another kind of selectable embodiment of the implant system 10 with bridgeware 790 of the present invention.Bridgeware 790 with first end 792 and second end 794 is depicted as the propons stopper 26 with one and is connected to back axle stopper 18.Should be understood that bridgeware 790 can have the back axle stopper of one, maybe can have propons stopper and back axle stopper.Bridgeware 790 desirably comprises the nitinol wire of the braiding with predetermined length.The nitinol wire of braiding desirably will be scheduled to scope (as, approximately 8cm is to about 10cm) be left straight.The predetermined portions of the nitinol wire of braiding (as, approximately 1cm is to about 3cm) be preformed, thus when the delivery catheter from right atrium discharges, curl to propons stopper 796.Figure 80 B and Figure 80 C show when the tension force that acts on bridgeware 790 increases (referring to Figure 80 B) or when reducing (referring to Figure 80 C), the structure that first end 792 (that is, the propons stopper 796) changes.
Above only think example to the principle of the invention.In addition, owing to be easy to carry out numerous modifications and variations, therefore will the present invention not be limited to definite structure and operation shown and that describe for those skilled in the art.Though, can not change details yet do not break away from the present invention who is defined by the claims to preferred embodiment being described.
Claims (42)
1. implant system comprises:
Bridgeware, it forms certain size and is constructed to cross over left atrium between great cardiac vein and interatrial septum,
The back axle stopper, it is connected to described bridgeware and docks vein tissue in described great cardiac vein,
The propons stopper, it is connected to described bridgeware and docks the interatrial septum tissue in right atrium, and
The bridgeware governor motion, its shortening and/or prolong described bridgeware.
2. implant system according to claim 1,
Wherein, described bridgeware reverses shortening described bridgeware along first direction, and/or described bridgeware reverses to prolong described bridgeware along second direction.
3. implant system according to claim 2,
Wherein, described bridgeware comprises ductile material.
4. implant system according to claim 1,
Wherein, described bridgeware further comprises the ring of bridgeware, and the ring of described bridgeware makes the length doubles of described fitting, and the adjusting ratio of 1/2 unit than 1 unit is provided.
5. implant system according to claim 1,
Wherein, described bridgeware comprises the nitinol wire of braiding and comprises the bridge stopper of one, and the nitinol wire of described braiding has first end and second end, and described first end comprises the preform part, thereby when described bridgeware is implanted, form the bridge stopper of described one.
6. implant system according to claim 5,
Wherein, described preform partly comprise about one centimetre to about three centimetres scope.
7. implant system according to claim 1,
Wherein, at least one comprises described bridgeware governor motion in described back axle stopper and the described propons stopper.
8. implant system according to claim 1,
Wherein, described bridgeware comprises the discontinuous pearl that stops, and regulates with discontinuous length to allow described bridgeware.
9. bridge stopper according to claim 1,
Wherein, described bridgeware comprises dentation tape portion or perforation tape portion or the screw spindle part to small part that extends through in described propons stopper and the described back axle stopper one.
10. bridge stopper according to claim 1,
Wherein, described bridgeware comprises the dentation tape portion that is connected to described bridgeware or perforation tape portion or screw spindle part, described dentation tape portion or described perforation tape portion or described screw spindle part extend through in described propons stopper and the described back axle stopper one to small part.
11. bridge stopper according to claim 1,
Wherein, described bridgeware further comprises first edge and second edge.
12. bridge stopper according to claim 11,
Wherein, at least one comprises the dentation pattern in described first edge and second edge.
13. bridge stopper according to claim 11,
Wherein, described first edge comprises the dentation pattern, and described second edge comprises the dentation pattern that the described dentation pattern from described first edge departs from.
14. bridge stopper according to claim 1,
Wherein, described bridgeware comprises at least one radio opaque markers thing.
15. bridge stopper according to claim 1,
Wherein, described bridgeware comprises and relocates ring.
16. bridge stopper according to claim 15,
Wherein, the described ring that relocates comprises at least one radio opaque markers thing.
17. bridge stopper according to claim 1,
Wherein, described bridgeware comprises metal material or polymeric material, perhaps the structure of the structure of form of wires or polymer line form, perhaps suture material, the perhaps mammiferous tissue of pericardium of pericardium of pericardium of horse or pig or cattle or preservation.
18. one kind is used to regulate the tensile system of implant, comprises:
Implant system limits as claim 1, and
Conduit, it has near-end and far-end, and described conduit has governor motion at its near-end.
19. system according to claim 18,
Comprise further relocating ring that the described ring that relocates is connected to described implant system.
20. system according to claim 18,
Wherein, described conduit governor motion comprises hook-shaped top.
21. system according to claim 19,
Wherein, the described ring that relocates comprises at least one radio opaque markers thing.
22. a bridge stopper device comprises:
Bridge stopper housing, it has length and width;
Aperture, it extends through the described length of described bridge stopper housing, described aperture form certain size and be constructed to allow bridgeware extend through described aperture to the described length of small part, and
Governor motion, it is connected to described bridge stopper housing to allow to regulate the length of described bridgeware.
23. bridge stopper according to claim 22,
Wherein, described governor motion comprises conduit, and described conduit is connected to described bridge stopper releasedly to activate described governor motion.
24. bridge stopper according to claim 22,
Wherein, described governor motion is arranged in the intravital described aperture of described bridge stopper shell.
25. bridge stopper according to claim 22,
Wherein, described governor motion comprises retainer.
26. bridge stopper according to claim 22,
Wherein, described governor motion allows only to prolong described bridgeware or only shortens described bridgeware.
27. bridge stopper according to claim 22,
Wherein, described governor motion allows to prolong described bridgeware and shortens described bridgeware.
28. bridge stopper according to claim 22,
Wherein, described governor motion forms certain size and is constructed to allow repeatably to regulate.
29. bridge stopper according to claim 22,
Wherein, described bridge stopper governor motion comprises static state, and
Described bridge stopper governor motion needs to allow to regulate the necessary forward actuation force of described bridgeware thus at the described bridgeware of the static limit of described governor motion.
30. bridge stopper according to claim 22,
Wherein, described bridgeware comprises the discontinuous pearl that stops, and regulates with discontinuous length to allow described bridgeware.
31. bridge stopper according to claim 22,
Wherein, described bridgeware comprises dentation tape portion or the perforation tape portion or the screw spindle part to small part of the described aperture that extends through in the described bridge stopper housing.
32. bridge stopper according to claim 22,
Wherein, the described length of described bridge stopper housing is greater than the described width of described bridge stopper housing.
33. bridge stopper according to claim 22,
Wherein, described bridge stopper housing further comprises at least one radio opaque markers thing.
34. bridge stopper according to claim 22,
Wherein, described bridge stopper comprises and relocates element.
35. bridge stopper according to claim 33,
Wherein, the described element that relocates further comprises at least one radio opaque markers thing.
36. a bridge stopper device comprises:
Bridge stopper housing, described housing comprises inside and outside, described housing has length and width;
Aperture, it extends through the described length of described bridge stopper housing, and described aperture forms certain size and is constructed to allow bridgeware to extend through the partial-length at least of described aperture, and
Governor motion, it is connected to described bridge stopper housing to allow to regulate described bridgeware.
37. bridge stopper according to claim 36,
Wherein, described governor motion comprises the rotation of described inside or described outside.
38. bridge stopper according to claim 36,
Wherein, described inside is arranged in the described outside fully.
39. bridge stopper according to claim 36,
Wherein, described interior section ground extends in the outside of described outside.
40. an implant system comprises:
Bridgeware, it forms certain size and is constructed to cross over left atrium between great cardiac vein and interatrial septum;
The first bridge stopper, it is connected to described bridgeware;
The second bridge stopper, it is connected to described bridgeware, and the described second bridge stopper comprises:
Bridge stopper housing, it has length and width,
Aperture, it extends through the described length of described bridge stopper housing, described aperture form certain size and be constructed to allow bridgeware extend through described aperture to the described length of small part, and
Governor motion, it is connected to described bridge stopper housing to allow to regulate described bridgeware.
41. according to the described implant system of claim 40,
Wherein, described bridge stopper housing further comprises inside and outside.
42. according to the described implant system of claim 40,
Wherein, described governor motion comprises the rotation of described inside or described outside, thereby makes it possible to prolong or shorten described bridgeware.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/089,940 | 2005-03-25 | ||
| US11/089,939 US20050228422A1 (en) | 2002-11-26 | 2005-03-25 | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools |
| US11/089,939 | 2005-03-25 | ||
| US11/089,949 | 2005-03-25 | ||
| US11/255,663 | 2005-10-21 | ||
| US11/255,529 | 2005-10-21 | ||
| US11/389,819 | 2006-03-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101184455A true CN101184455A (en) | 2008-05-21 |
Family
ID=39449420
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006800183909A Pending CN101184455A (en) | 2005-03-25 | 2006-03-27 | Devices, systems, and methods for reshaping a heart valve annulus |
| CN2006800183896A Expired - Fee Related CN101184454B (en) | 2005-03-25 | 2006-03-27 | Devices, systems, and methods for reshaping a heart valve annulus |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2006800183896A Expired - Fee Related CN101184454B (en) | 2005-03-25 | 2006-03-27 | Devices, systems, and methods for reshaping a heart valve annulus |
Country Status (1)
| Country | Link |
|---|---|
| CN (2) | CN101184455A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103930068A (en) * | 2011-08-12 | 2014-07-16 | 釜山大学校产学协力团 | Device for mitral valve membrane cerclage procedure |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9522062B2 (en) * | 2010-02-24 | 2016-12-20 | Medtronic Ventor Technologies, Ltd. | Mitral prosthesis and methods for implantation |
| EP2468215A1 (en) * | 2010-12-22 | 2012-06-27 | Centre Hospitaller Universitaire Vaudois (CHUV) | Annuloplasty ring |
| CN103491901B (en) * | 2011-04-04 | 2016-04-20 | 特拉维夫医学中心医学研究,基础设施及健康服务基金 | The equipment of heart valve repair and method |
| EP2522307B1 (en) * | 2011-05-08 | 2020-09-30 | ITSO Medical AB | Device for delivery of medical devices to a cardiac valve |
| US9855048B2 (en) | 2013-11-20 | 2018-01-02 | James E. Coleman | Controlling a size of a pylorus |
| US9848880B2 (en) | 2013-11-20 | 2017-12-26 | James E. Coleman | Adjustable heart valve implant |
| FR3021860A1 (en) * | 2014-06-05 | 2015-12-11 | Bernard Pain | TRANSCATHETER DEVICE FOR ABLATION OF CALCIFIED FABRICS AT THE LEVELS OF AN AORTIC VALVE |
| AU2016381357B2 (en) * | 2015-12-30 | 2019-11-28 | Pipeline Medical Technologies, Inc. | Mitral leaflet tethering |
| US9877833B1 (en) | 2016-12-30 | 2018-01-30 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
| US11083580B2 (en) | 2016-12-30 | 2021-08-10 | Pipeline Medical Technologies, Inc. | Method of securing a leaflet anchor to a mitral valve leaflet |
| US10925731B2 (en) | 2016-12-30 | 2021-02-23 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
| CN117959037A (en) * | 2017-08-04 | 2024-05-03 | 姆维亚克斯股份有限公司 | Delivery systems and methods for reshaping a heart valve annulus, including the use of magnetic tools |
| CN108543196B (en) * | 2018-05-16 | 2021-07-13 | 先柏（武汉）医疗科技有限公司 | Magnetic orientation kiss catheter |
| EP3893810A4 (en) | 2018-12-12 | 2022-12-14 | Pipeline Medical Technologies, Inc. | Method and apparatus for mitral valve chord repair |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6260552B1 (en) * | 1998-07-29 | 2001-07-17 | Myocor, Inc. | Transventricular implant tools and devices |
| US8956407B2 (en) * | 2000-09-20 | 2015-02-17 | Mvrx, Inc. | Methods for reshaping a heart valve annulus using a tensioning implant |
-
2006
- 2006-03-27 CN CNA2006800183909A patent/CN101184455A/en active Pending
- 2006-03-27 CN CN2006800183896A patent/CN101184454B/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103930068A (en) * | 2011-08-12 | 2014-07-16 | 釜山大学校产学协力团 | Device for mitral valve membrane cerclage procedure |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101184454A (en) | 2008-05-21 |
| CN101184454B (en) | 2010-10-20 |
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