CN101443073B - Method and apparatus for improving mitral valve function - Google Patents

Method and apparatus for improving mitral valve function Download PDF

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Publication number
CN101443073B
CN101443073B CN2005800469140A CN200580046914A CN101443073B CN 101443073 B CN101443073 B CN 101443073B CN 2005800469140 A CN2005800469140 A CN 2005800469140A CN 200580046914 A CN200580046914 A CN 200580046914A CN 101443073 B CN101443073 B CN 101443073B
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CN
China
Prior art keywords
stretching
carrier
coronary sinus
equipment
inner chamber
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CN2005800469140A
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Chinese (zh)
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CN101443073A (en
Inventor
J·M·鲁尔克
D·C·泰勒
S·J·布莱克
T·G·巴恩斯
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Viacor Inc
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Viacor Inc
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Publication of CN101443073A publication Critical patent/CN101443073A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451Inserts in the coronary sinus for correcting the valve shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3956Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A method and apparatus for reducing mitral regurgitation. The apparatus (90) is inserted into the coronary sinus (50) of a patient in the vicinity of the posterior leatlet of the mitral valve, the apparatus being adapted to straighten the natural cuwature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation. The apparatus is also configured to work in conjunction with an electrical lead (600) for an implantable bi-ventricular pacing device, an electrical lead for an implantable cardio defibrillator, etc.

Description

Be used to improve the method and apparatus of mitral valve function
Quoting of unsettled patent application formerly
Present patent application: be that to equal the part of the unsettled patent application formerly of the U.S. about " being used to improve the method and apparatus of mitral valve function " No. 10/446470 (attorney docket VIA-43) submitted on May 27th, 2003 by Jonathan Rourke follow-up (i); (ii) be that to equal the part of the unsettled patent application formerly of the U.S. about " being used to improve the method and apparatus of mitral valve function " No. 10/894676 (attorney docket VIA-48) submitted on July 19th, 2004 by Jonathan M.Rourke follow-up;
(iii) require to equal the rights and interests of the unsettled temporary patent application formerly of the U.S. about " being used to improve the method and apparatus of mitral valve function " No. 60/630606 (attorney docket VIA-49) of submission on November 24th, 2004 by Jonathan M.Rourke.
Thereby here by reference and in conjunction with above-mentioned three patent applications.
Invention field
The present invention relates generally to surgical method and equipment, more particularly, relate to the surgical method and the equipment that are used to improve mitral valve function.
Background technology
Mitral position is in heart between left atrium and the left ventricle.Bicuspid valve permission (at diastole) blood when left ventricle dilatation of an operate as normal flows to left ventricle from left atrium, and (at systole) prevents that blood is back to the left atrium from left ventricle when left ventricle is shunk.
In some cases, Bicuspid valve meeting cisco unity malfunction, thus cause refluxing.For example, mitral incompetence is the frequent phenomenon that occurs of patient of heart failure.The mitral incompetence of heart failure patient is that the change owing to the geometrical form of left ventricle, papillary muscles and annulus of mitral valve causes.These geometries changes cause leaflet of mitral valve not exclusively to engage.In this case, generally be to proofread and correct mitral incompetence with circumference that reduces this tensioner ring and the original geometry of recovering this annulus of mitral valve by this annulus of mitral valve of fold.
More particularly, be used to repair the practice of mitral surgical operation at present generally need open left atrium and fixingly sew up or be incorporated into the inner surface of this annulus of mitral valve to reduce the radius of this annulus of mitral valve with the support ring combinated seam more at large by operation; This structure is used in the mode of purse strings this annulus of mitral valve being stretched to littler radius, thereby improves the joint of lobule and reduce mitral incompetence.
This mitral valve repair method is commonly referred to as " annuloplasty ", and it has reduced the mitral incompetence of heart failure patient effectively.This has correspondingly alleviated the symptom of heart failure, has improved quality of life and has increased the time-to-live.Yet, regrettably, intervention essence of this Bicuspid valve operation (promptly generally be anesthesia, cut chest wall, cardiopulmonary bypass, cardiopulmonary stop, originally cutting on one's body to enter this Bicuspid valve or the like at heart) and the risk of being correlated with thereof cause most of heart failure patients to become bad surgical object.Thereby, thereby a kind of mode that increases the still less intervention property of lobule joint and minimizing heart failure patient mitral incompetence will make this therapy be suitable for the patient of bigger percentage ratio.
Mitral incompetence also occurs in about 20% the acute myocardial infarction patients.In addition, mitral incompetence is the main cause that develops into about 10% generation cardiogenic shock among the unsteady patient of serious hematodinamics under the acute myocardial infarction situation.The patient of mitral incompetence and cardiogenic shock has about 50% hospital mortality.The mitral incompetence of eliminating these patients will have significant benefit.Therefore yet regrettably, the patient of the concurrent acute myocardial infarction of acute mitral incompetence is high risk especially surgical object, is not the good object of traditional annuloplasty.Thereby, a kind of minimum intervention property mode that can temporarily reduce or eliminate these heavy patients' mitral incompetence will provide from the time of myocardial infarction or other life-threatening acute situation recoveries for them, and make them become the better object of other medical science, interference or operative therapy.
Summary of the invention
Therefore, an object of the present invention is to provide a kind of method of improved minimizing mitral incompetence.
Another object of the present invention provides a kind of equipment of improved minimizing mitral incompetence.
These and other purposes are realized by the present invention, comprise a kind of improved method and apparatus that is used to reduce mitral incompetence.
In a form of the present invention, a kind of device that is used to reduce mitral incompetence is provided, this device comprises:
The elongate carrier of making by enough flexible materials, be used for constructing first structure that roughly is consistent so that this carrier is inserted into coronary sinus with coronary sinus, with the structure the second more straight structure so that when when this more straight structure departs from, this carrier has a plurality of inner chambers of longitudinal extension therein; With
A plurality of stretching rods that are suitable for by the reception of the inner chamber in this carrier, each stretching rod is formed:
(i) than harder around organizing of posterior mitral leaflet; With
(ii) have the shape more straight than near the shape of the coronary sinus the posterior mitral leaflet; With
(iii) has the length enough with respect to the radius of curvature of this coronary sinus;
Thereby when this stretching rod is set in the inner chamber and this carrier is set in the coronary sinus with posterior mitral leaflet when adjacent, this stretching rod will apply stretching power to the wall of coronary sinus, thereby thereby move forward the back ring to improve lobule and engage and to reduce mitral incompetence;
Wherein the size of at least one inner chamber is set to receive electric wire therein.
In another form of the present invention, a kind of method that is used to reduce mitral incompetence is provided, the method comprising the steps of:
Provide and have a plurality of inner chambers flexible carrier of longitudinal extension therein;
Electric wire is advanced in the patient's blood vessel system, be arranged in patient's the coronary sinus, and lead is advanced in the patient's blood vessel system, be arranged in patient's the coronary sinus up to far-end with this electric wire up to far-end with this electric wire;
Advancing this carrier to be arranged in patient's the coronary sinus on this electric wire and the lead up to far-end with this carrier; With
Thereby a plurality of stretching rods are advanced in these a plurality of inner chambers so that to this carrier and this coronary sinus is applied stretching power, thereby move forward this mitral ring, thereby reduce mitral incompetence.
In another form of the present invention, a kind of method that is used to reduce mitral incompetence is provided, the method comprising the steps of:
Provide and have a plurality of inner chambers flexible carrier of longitudinal extension therein;
Electric wire is advanced in the patient's blood vessel system, be arranged in patient's the coronary sinus up to far-end with this electric wire;
Advancing this carrier to be arranged in patient's the coronary sinus on this electric wire up to far-end with this carrier; With
Thereby a plurality of stretching rods are advanced in these a plurality of inner chambers so that to this carrier and this coronary sinus is applied stretching power, thereby move forward this mitral ring, thereby reduce mitral incompetence.
In another form of the present invention, a kind of method that is used to reduce mitral incompetence is provided, the method comprising the steps of:
Provide and have a plurality of inner chambers flexible carrier of longitudinal extension therein;
Carrier is advanced in the patient's blood vessel system, be arranged in patient's the coronary sinus up to far-end with this carrier;
Electric wire is advanced in the patient's blood vessel system, be arranged in patient's the coronary sinus up to far-end with this electric wire; With
Thereby a plurality of stretching rods are advanced in these a plurality of inner chambers so that to this carrier and this coronary sinus is applied stretching power, thereby move forward this mitral ring, thereby reduce mitral incompetence.
In another form of the present invention, a kind of method that is used to reduce mitral incompetence is provided, the method comprising the steps of:
Provide and have a plurality of inner chambers flexible carrier of longitudinal extension and the electric wire that in inner chamber, extends therein;
Carrier is advanced in the patient's blood vessel system, be arranged in patient's the coronary sinus, and this electric wire is arranged in the heart tissue up to far-end with this carrier; With
Thereby a plurality of stretching rods are advanced in these a plurality of inner chambers so that to this carrier and this coronary sinus is applied stretching power, thereby move forward this mitral ring, thereby reduce mitral incompetence.
Description of drawings
, will be more completely open or these and other purposes of the present invention and feature are provided by following with reference to the detailed description of accompanying drawing for the preferred embodiment of the present invention, the parts that wherein similar numeral is similar, and wherein:
Fig. 1 is the part sketch map of human vascular system;
Fig. 2 is the part sketch map of human heart;
Fig. 3 shows the sketch map that is arranged on the intravital novel Annuloplasty equipment of patient;
Fig. 4 shows the sketch map of the preferred structure of this Annuloplasty equipment;
Fig. 5 and 6 is sectional views that line 5-5 and the 6-6 along Fig. 4 obtains;
Fig. 7,8,9,10 and 10A show the sketch map of multi-form stretching rod;
Figure 11 is the sectional view that the line 11-11 along Fig. 4 obtains;
Figure 12-14 is one group and shows the figure that uses this novelty Annuloplasty equipment to reduce mitral incompetence;
Figure 14 A shows the sketch map how different stretching rod of a cover can provide the stretching power of wide region;
It is how to be designed to fill in to reduce the sketch map of mitral incompetence with respect to the human body low-wound when coronary sinus is straightened that Figure 14 B shows this Annuloplasty equipment;
Figure 15 is the sketch map of auxiliary stretching rod;
Figure 16 shows stretching rod and assists stretching rod how to have the sketch map of the elasticity gradient of counter-rotating coordinate;
Figure 17-21 shows the various forms of push rods that are used for advancing to implant stretching rod;
Figure 22 shows the sketch map that is used for implant is fixed to releasedly a kind of optimal way on the catheter shaft;
Figure 23 shows the sketch map that is used for separating from this implant a kind of possibility mode of lead;
Figure 24 shows the sketch map of the mutual relation between excellent diameter, cross section profile, peak hardness and the peak strain;
Figure 25 shows inner chamber and how to be shaped to form the sketch map of closes flow route;
How the treatment part that Figure 26-28 shows this Annuloplasty equipment is formed with each cross section along its length;
Thereby Figure 29 shows the outer surface of this Annuloplasty equipment and how to be formed the help tissue growth and to strengthen stabilization of equipment performance;
Figure 30 shows the sketch map of another preferred form of the present invention, and wherein this Annuloplasty equipment comprises the structure of " individual unit ", and last at implantation process wherein, and the near-end of this Annuloplasty equipment is stored in " sack " in the patient thoracic cavity;
The sketch map of the Annuloplasty equipment near-end of capping Figure 30 before Figure 31 shows how in being stored in this tissue bag;
Figure 32-38 shows another preferred form of this Annuloplasty equipment; With
Figure 39 shows from the outwardly directed electric wire of the far-end of this Annuloplasty equipment.
Preferred embodiment describes in detail
General introduction
Coronary sinus is a vein maximum in the human heart.During its most of process in the chamber groove, this coronary sinus typically extends with the distance of the adjacent about 5-10cm of left atrium of heart.Importantly, a part of length for it for example typically is about 7-9cm, and this coronary sinus rear perimeter edge of adjacent annulus of mitral valve basically extends.The present invention has utilized this fact.More particularly,, can near posterior mitral leaflet, change the natural torsion of coronary sinus, thereby the ring that moves forward this rear portion engages to improve lobule by the novel equipment of adjacent posterior mitral leaflet configuration in coronary sinus, thus and minimizing mitral incompetence.
Patient anatomy
Refer now to Fig. 1 and 2, wherein show the outward appearance of patient's cardiovascular system 5.More particularly, cardiovascular system 5 generally comprises heart 10, superior vena cava 15, right subclavian vein 20, left subclavian vein 25, jugular vein 30 and postcava 35.Superior vena cava 15 and postcava 35 are communicated with the right atrium 40 of heart.Crown ostium 45 leads to coronary sinus 50.At the far-end 55 (Fig. 2) of coronary sinus 50, blood vessel structure leads to anterior interventricular vein (" AIV ") 60 (Fig. 1 and 2) of vertical decline.For the purposes of the present invention, generally can simply be interpreted as the blood vessel structure that between crown ostium 45 and AIV 60, extends to term " coronary sinus ".
As shown in Figure 2, between crown ostium 45 and AIV 60, coronary sinus 50 generally be basically with the adjacent extension of rear perimeter edge of the ring 65 of Bicuspid valve 70.Bicuspid valve 70 comprises back lobule 75 and preceding lobule 80.Under the mitral situation of anti-stream, back lobule 75 and preceding lobule 80 generally are can not normal engagement at systole, thereby have stayed insertion gap 85, cause taking place undesirable anti-stream.
The Annuloplasty device overview
Then see Fig. 3 and 4, wherein show Annuloplasty equipment 90, it comprises a preferred form of the present invention.Annuloplasty equipment 90 comprises the catheter shaft 100 that is used for rebuilding the implant 95 (Fig. 4) of annulus of mitral valve in medical treatment and is used for implant 95 is transported to treatment position.In a kind of preferred structure, implant 95 and catheter shaft 100 are formed single structure.Standard guide bushings 105 (Fig. 3) and lead 110 can be used for Annuloplasty equipment 90 is directed into patient's coronary sinus.
Implant
3-6 with the aid of pictures then, in a preferred form of the present invention, implant 95 comprises leading part 115 and treatment part 120.
Leading part 115 comprises far-end 125 and near-end 130.Leading part 115 preferably is tapered along its length, has narrower distal tip, and diameter increases when it extends on proximal direction, thereby makes this leading part that attenuates 115 can assist far-end the moving in blood vessel structure of implant 95.Leading part 115 comprises from its far-end at least one inner chamber 135 (Fig. 5) to its proximal extension.Inner chamber 135 uses standard percutaneous tranmission techniques to assist equipment transporting in lead 110, as hereinafter going through.
Leading part 115 is preferably formed by soft relatively, flexible material, soft silicone rubber for example, and its size is set to when its near-end 130 is positioned at the junction of coronary sinus and anterior interventricular vein (AIV), and its far-end 125 can be received among the AIV downwards.Preferably, one or more radio opaque markers devices 140 (Fig. 3 and 4) are set near far-end 125 places of leading part 115 or its, thereby make it possible to see by fluoroscopy etc. the position of far-end 125.
Treatment part 120 comprises the carrier 145 with far-end 150 and near-end 155.The far-end 150 of carrier 145 is fixed to the near-end 130 of leading part 115, thereby when Annuloplasty equipment 90 advanced in blood vessel structure, leading part 115 can soft relatively, low-wound ground guiding treatment part 120.In a preferred structure, leading part 115 and treatment part 120 form single structure.Preferably, one or more radio opaque markers 160 (Fig. 3 and 4) are set near treatment far-end 150 places of part 120 or its, one or more radio opaque markers 165 are set near treatment near-end 155 places of part 120 or its, thereby make it possible to see by fluoroscopy etc. the position of treatment part 120.
Carrier 145 comprises at least one, is preferably a plurality of work inner chambers 170 (Fig. 6) that extend to its far-end 150 from its near-end 155.Work inner chamber 170 can all have mutually the same diameter, and perhaps they can have the diameter that differs from one another.In a preferred structure, three identical work inner chambers 170 that center on the central shaft equidistant placement of carrier 145 extend to the far-end 150 of carrier 145 basically always from the near-end 155 of carrier 145.
In a preferred structure, carrier 145 can also comprise at least one, be preferably a plurality of auxiliary lumen 175 (Fig. 6) of extending to its far-end 150 from its near-end 155.Auxiliary lumen 175 can all have mutually the same diameter, and perhaps they can have the diameter that differs from one another.And one or more auxiliary lumen 175 can have the diameter identical with one or more work inner chamber 170.In a preferred structure, center on the central shaft equidistant placement of carrier 145 and diameter extends to carrier 145 basically always from the near-end 155 of carrier 145 less than three identical auxiliary lumen 175 of the diameter of work inner chamber 170 far-end 150.
At least one work inner chamber 170 and/or auxiliary lumen 175 are communicated with at least one inner chamber 135 (Fig. 5) that extends continuously in leading part 115, thereby the standard of use percutaneous tranmission techniques transports equipment in lead 110, as hereinafter going through.In a preferred structure, a work inner chamber 170 in the carrier 145 is communicated with an inner chamber 135 that extends in conductor part 115.
Carrier 145 is preferably made by the material of relative flexibility, thereby low-wound ground is advanced to carrier 145 in patient's the coronary sinus relatively, and can not cause the natural geometry shape generation significant change of coronary sinus, as hereinafter discussing.In addition, carrier 145 is preferably made by the material of relative low-frictional force, thereby can be easily in the patient's blood vessel system, advance carrier 145 (for example easily in lead, advancing), thereby and can easily rod, lead etc. be advanced in the inner chamber 170 and 175 of carrier 145 or therefrom pull out.In a preferred embodiment, carrier 145 is made by Teflon.
Work inner chamber 170 is used for optionally receiving stretching rod so that annulus of mitral valve is rebuild in medical treatment, as hereinafter discussing.A preferred form of stretching rod is shown in Figure 7 stretching excellent 180.
Refer now to Fig. 3,7,14, each stretching excellent 180 forms:
(i) than harder around organizing of posterior mitral leaflet; With
(ii) have the shape more straight than near the shape of the coronary sinus the posterior mitral leaflet; With
(iii) has the length enough with respect to the radius of curvature of this coronary sinus;
Thereby be set in the work inner chamber 170 of carrier 145 and this carrier when being set in patient's the coronary sinus adjacent when stretching excellent 180 with posterior mitral leaflet, this stretching rod will apply stretching power to the wall of coronary sinus, thereby thereby the ring that moves forward the rear portion engages and the minimizing mitral incompetence to improve lobule, as hereinafter discussing.
In other words, each stretching excellent 180 size and glacing flatness are set to, in the time of in being placed on this bending coronary sinus, stretching excellent 180 can not be held by this coronary sinus, and can not cause coronary sinus or stretching rod or the geometry of the two to change, and by making this stretching rod slightly harder than relative organization, the configuration of this stretching rod in coronary sinus will cause the geometry of this tissue to change, thereby regulate mitral shape, and then reduce mitral incompetence, as hereinafter discussing.
In a preferred form of the present invention, each stretching excellent 180 comprises slightly flexible straight substantially bar (under stress-free conditions), thereby makes this bar can be flexiblely apply stretching power to the wall of coronary sinus.
Each stretching excellent 180 can be accurately applies identical stretching power of each stretching rod with other to the wall of coronary sinus, and perhaps this stretching rod can be designed to provide stretching power in various degree.In a preferred form of the present invention, kit comprises a plurality of different stretching excellent 180, and each provides stretching power in various degree, and the suitable selection by the doctor provides.The difference of stretching power can be by excellent hardness difference (can realize by the difference of bar construction, excellent diameter etc.), excellent length difference, rod position difference relative to each other or the like realizes when using a plurality of rod.
In a preferred form of the present invention, each stretching excellent 180 wall to coronary sinus applies power, itself only is enough to make annulus of mitral valve to move and reduces the finally part of total distance of needs of mitral incompetence institute.In this form of the present invention, can on carrier 145, dispose additional stretching excellent 180 so that provide additional stretching power to annulus of mitral valve; And/or can in one or more auxiliary lumen 175, dispose additional stretching rod so that provide additional stretching power to annulus of mitral valve; And/or can in carrier 145, on it or around it, additional stretching parts be set so that provide additional stretching power to annulus of mitral valve.With example rather than restrictive mode, additional stretching rod can be molded in the main body of the carrier 145 in work inner chamber 170 and auxiliary lumen 175 peripheral regions; And/or on the outer surface of carrier 145, form outside stretching slit or shell or pipe.
In addition, perhaps as aforesaid optional, this equipment can constitute to annulus of mitral valve and apply the stretching power of elasticity, thereby only can make at first annulus of mitral valve move to reduce the power of a part of total distance of the final needs of mitral incompetence institute can dynamically bring into play its therapeutic effect along with the time of this crown tissue reconstruction.
In a preferred form of the present invention, each stretching excellent 180 comprises the multi-region section bar with different flexible regions.Therefore, the different piece of annulus of mitral valve can be reconfigured the lobule joint of not commensurability power to realize improving.
In a specific preferred form of the present invention, each stretching excellent 180 comprises " 5 sections bars " similar with disclosed 5 section bars in No. 60/630606 to for example aforesaid U.S. Patent application the 10/446470th, 10/894676, refer now to Fig. 7, each stretching excellent 180 comprises central area (or hinge) S with selected degree of flexibility 1, have than central area S 1The extension of lower degree of flexibility (or arm) S 2And have than central area S 1The end portion of high flexibility degree (or foot) S more 3Basically, utilize this 5 sections bars, central area S 1Be provided for meshing " saddle " of annulus of mitral valve, arm S 2Be provided for transmitting the rigid structure of load to the lateral wall of coronary sinus, and foot S 3For this load is provided at " soft landing " on the coronary sinus outer wall.Have been found that this 5 sections bars are a kind of particularly advantageous structures, because (1) mode that these 5 sections bars can a kind of " high resiliency energy wall " will himself be arranged on the coronary sinus center and in the position around the posterior mitral leaflet, thereby reduce undesirable longitudinal rod skew, (2) these 5 sections bars joint-bond sizes of can not increasing this lobe by the mitral A-P size that reduces expansion is improved lobule and is engaged, thereby reduce formation undesirable " side spray " and (3) these 5 sections bars and also be found the anatomic differences that reasonably well to hold patient-patient.
In fact, each stretching excellent 180 also is preferably and is formed with a tapered distal end 185 (Fig. 7), its end is a low-wound ball point 190, thereby make that stretching excellent 180 can be advanced to the work inner chamber 170 of carrier 145 from external position at an easy rate when carrier 145 is set in patient's the coronary sinus.As the result of aforementioned structure, each stretching excellent 180 has additional remote part S effectively 4, it has than aforementioned end portion S 3Higher degree of flexibility.
If desired, one or more stretching excellent 180 can have the different flexible region S that provide by the different rod diameter by single a kind of material (for example Nitinol) 1, S 2, S 3And S 4(for example referring to structure shown in Figure 8); And/or stretching excellent 180 can two or more are different material (for example rustless steel and Nitinol etc.) be combined in the composite construction (for example referring to structure shown in Figure 9, wherein this stretching rod comprises Nitinol and stainless alternating segments, the perhaps structure shown in Figure 10 and the 10A, wherein this stretching rod comprises Nitinol and stainless arranged concentric) or the like.
Catheter shaft
Catheter shaft 100 (Fig. 4) is used for implant 95 is transported to treatment position.Catheter shaft 100 comprises far-end 195 and near-end 200.The near-end 155 of the far-end 195 engagement implants 95 of catheter shaft 100, catheter shaft 100 moves to treatment position with implant 95 simultaneously.In a form of the present invention, catheter shaft 100 can optionally be separated with the near-end 155 of implant 95, for example at implant 95 after after this some points are transported to treatment position.At last, as hereinafter will going through, implant 95 can form and separate with catheter shaft 100 and be detachably fixed on it.In another form of the present invention, implant 95 can form with catheter shaft 100 one and can optionally separate (for example by cutting) afterwards with it.In another form of the present invention, implant 95 and catheter shaft 100 can form single structure, and in use remain on this state.
Catheter shaft 100 comprises the sufficiently long elongated structure of being made by enough flexible materials, thereby makes catheter shaft 100 can be used to advance implant 95 to arrive coronary sinus through the patient's blood vessel system.By example rather than restrictive mode, catheter shaft 100 can have certain-length and flexible so that it can be used for jugular vein or the right side of trunk or the inlet point of left subclavian vein of implant 95 from cervical region, be advanced to downwards and enter vein, enter superior vena cava downwards, through the heart right atrium, enter coronary sinus then.
See Fig. 4 and 11 below, catheter shaft 100 comprises at least one, is preferably a plurality of work inner chambers 205.Work inner chamber 205 extends and passes through catheter shaft 100 fully at far-end 195 openings of catheter shaft 100, and at near-end 200 openings of catheter shaft 100.Work inner chamber 205 provides for the entering of the work inner chamber 170 in the carrier 145, and is last, and the quantity and the alignment with it of the work inner chamber 170 that provides in the carrier 145 preferably quantitatively is provided the work inner chamber 205 in the catheter shaft 100.
In a preferred construction, catheter shaft 100 can also comprise at least one, be preferably a plurality of auxiliary lumen 210.Auxiliary lumen 210 is at far-end 195 openings of catheter shaft 100, and extend and pass through catheter shaft 100 fully, and at near-end 200 openings of catheter shaft 100.Auxiliary lumen 210 provides for the entering of the auxiliary lumen in the carrier 145 175, and is last, and the quantity and the alignment with it of the auxiliary lumen 175 that provides in the carrier 145 preferably quantitatively is provided the auxiliary lumen 210 in the catheter shaft 100.
Use
The preferably following use of Annuloplasty equipment 90.
The first, be incorporated into standard guide bushings 105 (Fig. 3) in the patient's blood vessel system and be advanced in the coronary sinus.By example rather than restrictive mode, this can be advanced to superior vena cava downwards by in the jugular vein (or patient's the right side or left subclavian vein) that this guide bushings is inserted into patient, through the right atrium of heart, enters the opening of crown ostium then.Then, lead 110 is advanced to (Figure 12) in the coronary sinus through this standard guide bushings 105.Then, Annuloplasty equipment 90 is loaded on the lead 110.Be constructed such that at Annuloplasty equipment 90 Annuloplasty equipment 90 can be used as a unit and is loaded on the lead 110 under the situation that implant 95 and catheter shaft 100 become one mutually.Be constructed such that at Annuloplasty equipment 90 implant 95 and catheter shaft 100 form under the situation separated from one another, can before being loaded on the lead 110, implant 95 and catheter shaft 100 be become one, perhaps can be respectively implant 95 and catheter shaft 100 be loaded on the lead 110 and after it is gathered together.No matter be when implant 95 and catheter shaft 100 are integrated one (promptly at production period, before being loaded on the lead 110 or after being loaded into lead 110), implant 95 and catheter shaft 100 all are to be integrated one, so that the work inner chamber 170 in the carrier 145 aligns with work inner chamber 205 in the catheter shaft 100, thereby and make the auxiliary lumen 175 in the carrier 145 align with the auxiliary lumen 210 in the catheter shaft 100.Preferably, the work inner chamber by transmitting alignment on the near-end of lead 110 is to 170,205 with Annuloplasty equipment 90 is loaded on the lead 110 to distant place pushing ring plasty equipment 90 along this lead.Alternatively, auxiliary lumen that can be by transmitting alignment on the near-end of lead 110 is to 175,210 and Annuloplasty equipment 90 is loaded on the lead 110 to distant place pushing ring plasty equipment 90 along this lead; Perhaps on Annuloplasty equipment 90, provide other inner chambers so that Annuloplasty equipment 90 is loaded on the lead.
Then, Annuloplasty equipment 90 is advanced near the treatment part 120 with it is set to posterior mitral leaflet downwards along lead 110, simultaneously leading part 115 extends downwards along AIV, is positioned at the joint (Fig. 3 and 13) of coronary sinus and AIV than the joint of domestic strong treatment part 120 and leading part 115.The labelling 140,160 and/or 165 that does not see through ray can be used for helping locating ring plasty equipment 90 under situations such as fluoroscopy.
Preferably, when Annuloplasty equipment 90 is advanced to treatment position, do not have stretching excellent 180 to be set in the work inner chamber 170 of treatment part 120.Therefore, because carrier 145 is made by the relative flexibility material, so when Annuloplasty equipment 90 advanced in the patient's blood vessel system, carrier 145 can bend at an easy rate, thereby assistance equipment advances.This is a significant advantage of the present invention, because it allows to dispose Annuloplasty equipment with the equipment twist risk of minimum organization wound and minimizing.
Because carrier 145 made by the relative flexibility material, can be expected at along lead 110 downward pushing ring plasty equipment 90 and before obturator is inserted into any untapped work inner chamber in 170,205.These obturators can assist to open untapped inner chamber, and especially, when carrier 145 is crooked, aids in when stretching rod is advanced in the carrier subsequently and stop stretching rod to be trapped in the sidewall of carrier.For example, have at carrier 145 under the situation of three work inner chambers 170, the obturator that is arranged in two work inner chambers 170 can be provided for guiding stretching rod to be inserted into " guide rail " of other (promptly the 3rd) work inner chamber.Yet, in this respect, also will be appreciated that, can wish that generally this obturator is flexible as much as possible, thereby make them can keep untapped work inner chamber to open 170,205, and not significantly bending of prevention equipment and/or propelling.
Similarly, can obturator be inserted in any untapped auxiliary lumen 175,210 before lead 110 downward pushing ring plasty equipment 90.
Treatment part 120 is set in the coronary sinus adjacently with posterior mitral leaflet in case Annuloplasty equipment 90 is advanced in the patient's blood vessel system, just is recoverable to lead 110.Alternatively, lead 110 inner chambers of living in are used under the situation of other purposes not needing, lead 110 can be retained in the original place.This will be favourable, because when lead 110 extends in Annuloplasty equipment 90, can provide support for its inner chamber of living in (inner chamber of promptly working is to 170,205).
Then, be advanced in the work inner chamber 170 of carrier 145 one or more stretching excellent 180.Preferably, this is by at first advancing the work inner chamber 170 that enters carrier 145 stretching excellent 180 through the work inner chamber 205 of catheter shaft 100, then to realize.The inner chamber 205 and 170 of working during Annuloplasty equipment 90 is inserted into coronary sinus is full of under the situation of obturator or lead, regains it before inserting this stretching rod.
Along with each stretching excellent 180 is inserted in the work inner chamber 170 of carrier 145, this carrier become more and more harder and thereby more straight, rebuild mitral geometry of this expansion gradually, thereby promote lobule thereafter forward, and then reduce mitral incompetence (Figure 14).Along with subsequently each stretching excellent 180 is inserted in the work inner chamber 170 of carrier 145, can observe the degree of mitral incompetence, this process is proceeded up to anti-flow process degree minimum.If desired, can remove the stretching excellent 180 of previous placement, and/or replace, thereby improve tissue reconstruction and reduce mitral incompetence with different stretching rods.In fact, be inserted in the carrier 145 simultaneously that this carrier is set in the coronary sinus along with stretching excellent 180, implant 95 is assembled on the spot.This method provides a plurality of remarkable advantages.In other factors, stretching excellent being inserted in proper order allowed in the carrier 145 to implement this treatment with " step-by-step system ", thereby allow " fine setting " this tissue reconstruction so that can optimize treatment.In this respect, stretching excellent 180 forms that are preferably to comprise stretching excellent 180 the tool kit of a plurality of differences that should be noted that provide, and each provides stretching power in various degree, thereby assist to transmit the tissue reconstruction power of optimal number.For example referring to Figure 14 A, wherein showing three different stretching excellent length and each, six kinds of different hardness are provided is the selections how 18 kinds of stretching power of available difference are provided for the doctor.In addition, be progressive being applied on the patient body because this treatment loads, so reduced tissue injury.And because the present invention has used wound equipment still less, so this system unit can be done simplyr and be more cheap.By reading this description, those skilled in the art will recognize that other advantages of novel method of the present invention.
In addition, the material by utilizing relatively low friction for example Teflon is made carrier 145, and stretching excellent 180 will be received in the carrier 145 slidably, and carrier 145 will be received in the coronary sinus 30 slidably.Therefore, when subsequently stretching excellent 180 be inserted in the carrier 145 and when moving forward this rear portion ring gradually, the far-end of this equipment and near-end will adopt the needs of more straight structure and freely outwards slide according to this equipment.
More particularly, present 14B with the aid of pictures, the treatment part 120 that shows this Annuloplasty equipment is configured in the patient body.When treatment part 120 since stretching excellent 180 insertion and from non-stretching state (solid line) when stretching state (dotted line) shifts, the far-end of treatment part 120 and near- end 150 and 155 are according to the changes shape of the length of this treatment part and this tissue and along this tissue low-wound ground slip (promptly moving a certain distance X).Make carrier 145 by the material (for example Teflon) that utilizes relatively low friction, low-wound ground realizes that this equipment slides relatively.In fact, because rebuild this tissue gradually, also take place gradually so this equipment slides, thereby further reduced tissue injury along with the insertion of each stretching rod subsequently.
If desired, can also use so-called stylet to send configuration Annuloplasty equipment 90.In this case, use lead that sleeve pipe is advanced in the coronary sinus, remove lead, Annuloplasty equipment 90 is advanced in the sleeve pipe in this coronary sinus, remove this sleeve pipe then, Annuloplasty equipment 90 is retained on the tram in the coronary sinus.In this case, far-end 130 that can locking ring plasty equipment 90 is no longer needed (for example be used to hold electric pin, vide infra) by some other purpose up to it.
Other preferred construction details
Stretching excellent 180 size and dimension is configured to will make that coronary sinus is stretching when they are configured in the coronary sinus.More particularly, each stretching excellent 180 is formed: (i) than harder around organizing of posterior mitral leaflet; (ii) has the more straight shape of natural torsion than near the coronary sinus of patient posterior mitral leaflet; (iii) has the length enough with respect to the radius of curvature of this coronary sinus; Thereby when stretching rod is set in patient's the coronary sinus, it will apply stretching power to coronary sinus, thereby posterior mitral leaflet is applied forward power to reduce mitral incompetence.
Importantly, carrier 145 can be constituted as and make and himself only the wall of coronary sinus is applied nominal stretching power.This layout can be very favorable, because it means that can easily will lack stretching excellent 180 carrier 145 with low-wound ground is advanced to treatment position.
And importantly, each stretching excellent 180 needs applies the part that will be applied to the total stretching power on the coronary sinus, because can utilize a plurality of stretching accumulative effects of excellent 180.This is very favorable, can easily with low-wound ground each single stretching rod be advanced to treatment position because it means.
And, importantly, by when using the stretching rod of one or more separate configurations, applying stretching power to Bicuspid valve, can be by using more or less stretching bar and/or waiting the stretching power that applies in various degree by the stretching bar that uses more or less hardness.
Importantly, by utilize elastomeric material make each stretching excellent 180, each stretching excellent 180 needs applies realizes that basically complete lobule engages the part of required power, because when this tissue is rebuild gradually, this stretching rod can dynamically realize that lobule engages along with the time.In this respect, it should be noted that, tissue tends to dynamic response, thereby can use rods to come this tissue of progressive driving to move closer to the final position, thereby realize tissue reconstruction in a time cycle, wherein this tissue will be subjected to than the tissue reconstruction wound still less that realizes fully a moment expecting.
If desired, can also before being advanced to Annuloplasty equipment 90 in the coronary sinus, be pre-loaded onto in one or more work inner chambers 170 of treatment part 120 stretching excellent 180; Perhaps can before being advanced to Annuloplasty equipment 90 in the coronary sinus, be pre-loaded onto in one or more work inner chambers 205 of catheter shaft 100 stretching excellent 180.Yet, as mentioned above, generally more wish after Annuloplasty equipment 90 being advanced in the coronary sinus, to be loaded in the work inner chamber 170, thereby keep flexible during making this Annuloplasty equipment in being inserted into patient's coronary sinus as much as possible stretching excellent 180.
If desired, can be inserted into stretching rod in the auxiliary lumen 175 of carrier 145 to realize stretching this Bicuspid valve of expection.This can realize by being inserted into stretching rod in the work inner chamber 170 simultaneously or as an alternative stretching rod being inserted in the work inner chamber 170.
In a preferred structure, it is stretching with the ring of realizing expection all to dispose stretching rod in work inner chamber 170 and auxiliary lumen 175.
In a particularly preferred structure, it is stretching that the flexibility of the stretching rod in the work inner chamber 170 and the flexibility one of the stretching rod in the auxiliary lumen 175 are shown the improved ring of realization.
More particularly,, will recall referring now to Fig. 7, in a preferred form of stretching excellent 180, stretching excellent 180 distal portions S 4Have higher relatively degree of flexibility, thereby assist stretching rod is advanced in patient's the coronary sinus at intracavity.Yet this feature also has minimizing by distal portions S 4The effect of the stretching power that is produced, this will to coronary sinus should the zone the stretching adverse effect of bringing of ring.At last, see Figure 15 now, provide a kind of auxiliary stretching excellent 211, it comprises the proximal part S with first degree of flexibility at least 5With distal portions S with second higher degree of flexibility 6, distal portions S wherein 6Flexibility and stretching excellent 180 distal portions S 4Flexible consistent, thereby the stretching power of ring of expection is provided jointly.
In a preferred form of the present invention, auxiliary stretching excellent 211 far-end has the flexible gradient that reduces on proximal direction, thereby compensates stretching excellent 180 the far-end with the flexible gradient that increases on proximal direction.Schematically shown this effect among Figure 16.These flexible gradients can obtain in every way, for example by changing excellent diameter, use more than a kind of structural material etc.
In a kind of preferred form of the present invention, before being advanced to Annuloplasty equipment 90 in the coronary sinus, be configured in the auxiliary lumen 210, after Annuloplasty equipment 90 being advanced in the coronary sinus, be configured in the work inner chamber 170 then one or more stretching excellent 180 with one or more stretching excellent 211.
If desired, stretching excellent 180 can make by adapting to the strained material of height that is applied on stretching excellent 180 (for example highly elastic material for example Nitinol), and stretching excellent 211 can provide carrier 145 required high-intensity material (for example operation rustless steel) by another kind.
As mentioned above, generally can wish after Annuloplasty equipment 90 being advanced in the coronary sinus, to be inserted in the work inner chamber 170, thereby assist to make Annuloplasty equipment 90 enter into coronary sinus stretching excellent 180.
In a kind of form of the present invention, can use a simple push rod 215 (Figure 17) to promote stretching excellent 180 by the work inner chamber 205 in the catheter shaft 100 and enter the work inner chamber 170 of treatment in the part 120.Push rod 215 can with stretching excellent 180 form separately or become one.In a kind of preferred form of the present invention, push rod 215 forms as one with stretching excellent 180 or is connected to stretching excellent 180.
In some cases, can wish to remove stretching excellent 180 from work inner chamber 170.By the mode of example rather than restriction, need or wish to replace a stretching rod with another stretching rod when treating part 120 when being arranged in coronary sinus, be applied to power on the annulus of mitral valve with adjusting.Perhaps can need or wish to remove the Annuloplasty equipment 90 that is disposed from coronary sinus, this correspondingly will need or wish to remove stretching excellent 180 from treatment part 120 when the treatment part is arranged in coronary sinus.Form one with stretching excellent 180 or be connected under stretching excellent 180 the situation at push rod 215, remove stretching excellent 180 from treatment part 120 and be easy to realize; In this case, can remove stretching excellent 180 by the near-end of on proximal direction, pulling out push rod 215 simply.
Removing stretching excellent 180 from treatment part 120 can also realize by the far-end that stretching excellent 180 near-end is coupled to releasedly the push rod that is used to advance this stretching rod.
More particularly, see Figure 18 now, wherein show the push rod 220 that is fixed to releasedly on stretching excellent 180.Push rod 220 comprises far-end 225 and near-end 230.Flexible coil spring 235 is preferably on the far-end 225 that is formed on push rod 220 and meshes stretching excellent 180 near-end.Handle 240 is fixed on the near-end 230 of push rod 220.Central lumen 255 is formed in the push rod 220.Central lumen 255 receives stretching lead 260.One end of stretching lead 260 is connected to stretching excellent 180 near-end, and the other end of stretching lead 260 is connected to the stretcher 265 by handle 240 loads.
In use, when stretching excellent 180 are connected to push rod 220, use handle 240 with in the stretching excellent 180 work inner chambers 170 that are advanced in the treatment part 120, perhaps if desired, from 170 withdrawals stretching excellent 180 of work inner chamber.Then, if separate stretching excellent 180 from push rod 220, can use 265 pairs of stretching leads 260 of stretcher to apply enough pulling force so that the stretching lead is discharged from stretching excellent 180, thereby can be from Annuloplasty equipment 90 withdrawal push rods 220 and in the stretching excellent 180 work inner chambers 170 that still remain on the treatment part 120.
Figure 19-21 shows and is used for stretching rod is coupled to other equipment on the push rod releasedly.The structure of Figure 19-21 and the structural similarity of Figure 18, wherein they all allow stretching excellent 180 to be coupled to this push rod releasedly, but they also have other advantages, and promptly the structure of Figure 19-21 allows to be obtained by push rod again after push rod discharges at stretching rod.
See Figure 19 below, wherein show and be used for being fixed to releasedly on the push rod 220 so that this push rod can obtain the structure of this stretching rod subsequently once more stretching excellent 180.More particularly, utilize this specific structure, (i) stretching excellent 180 near-end comprise recess 270 and (ii) push rod 220 comprise and outer be in charge of 275 and inner wedge bar 280.When inner wedge bar 280 from outside when being in charge of 275 proximal retraction, be in charge of 275 inner surfacies that will adopt relaxation state so that it can slip into and skid off recess 270 and can not firmly grasp recess 270 outward.Yet, when outside be in charge of 275 and be placed in the recess 270 and when outside far-end is advanced to, being in charge of inner wedge bar 280 in 275 then, be in charge of 275 states that will be forced expanded in diameter outward, can firmly grasp the inner surface of recess 270 thereby be in charge of 275 outside making, thereby be fixed on the push rod 220 stretching excellent 180.Then can by from outside be in charge of 275 to proximal retraction inner wedge bar 280 to discharge from push rod 220 with stretching excellent 180, regain push rods 220 from stretching excellent 180 then.
See Figure 20 below, wherein show and be used for the another kind of possible structure that is fixed to releasedly on the push rod 220 stretching excellent 180.More particularly, utilize this specific structure, (i) stretching excellent 180 near-end comprise male part 285 and (ii) the far-end of push rod 220 comprise spring recess 290 and (iii) sealed tube 295 be installed in one heart on the push rod 220.Utilize this structure, when sealed tube 295 from spring recess 290 during to proximal retraction, the spring state that the near-end of push rod 220 loosens employing is so that spring recess 290 can advance on male part 285 or male part 285 promptly from its withdrawal and.Yet, when the near-end of push rod 220 advance on the male part 275 and sealed tube 295 then on the spring recess 290 when far-end advances, the far-end of push rod 220 will be firmly grasped male part 285, thereby be fixed on the push rod 220 stretching excellent 180.By discharging from push rod 220 stretching excellent 180, regain push rod 220 from stretching excellent 180 then then from spring recess 290 withdrawal sealed tubes 295.
See Figure 21 below, show wherein that be used for may structure with stretching excellent 180 another kinds that are fixed to releasedly on the push rod 220.More particularly, utilize this specific structure, stretching excellent 180 and push rod 220 in one or another comprise half of bayonet mount, stretching excellent 180 and push rod 220 in another comprise second half of bayonet mount, thereby stretching excellent 180 can be releasably connected to push rod 220.
According to this description, those skilled in the art will know other modes that are fixed to releasedly on the push rod 220 stretching excellent 180 of being used for.
As mentioned above, catheter shaft 100 (Fig. 4) is used for implant 95 is sent to the treatment place.When catheter shaft 100 was transported to treatment position with implant 95, the near-end of the far-end of catheter shaft 100 195 engagement implants 95 in forms more of the present invention, was preferably at subsequently certain point and separates with the near-end 155 of implant 95.At last, implant 95 can form and separate with catheter shaft 100 and removably be fixed to the upper, and perhaps implant 95 can form as one with catheter shaft 100 and separate with it subsequently.
Form under the situation of separating with catheter shaft 100 and removably being fixed to the upper at implant 95, can use various layouts optionally to connect these parts.
In a preferred construction, see Figure 22 now, lead 300 can be used for implant 95 is fixed to catheter shaft 100 releasedly.More particularly, the far-end of one or more leads 300 is fixedly installed in the auxiliary lumen 175 of treatment in the part 120, and in the auxiliary lumen 210 of catheter shaft to proximal extension.Then, by pushing the far-end 195 of catheter shaft 100 with respect to the near-end 155 of treatment part 120, the lead 300 that stretches simultaneously is so that its tension, and implant 95 and catheter shaft 100 are configured to as a cell operation.More particularly, when Annuloplasty equipment 90 is advanced in patient's the coronary sinus downwards along lead 110, use catheter shaft 100 to promote implant 95 to far-end.The Annuloplasty equipment 90 of withdrawing if desired can be pulled out lead 300 to near-end, pulls out implant 95 (thereby and pulling out catheter shaft 100 to near-end) to near-end.
If desired implant 95 is retained in treatment position and regains catheter body 100 from it, pull out lead 300 and catheter shaft 100 keeps static to near-end so, thereby lead 300 will be pulled out disengaging with implant 95, thereby lead 300 and catheter shaft 100 can be regained from treatment position.Figure 23 show be used to obtain a kind of of this result may structure, wherein lead 300 is installed in the auxiliary lumen 175 by friction but can regains (i.e. the powerful pulling force of near-end when use catheter shaft 300 is held in place implant 95) based on applying enough power.
Alternatively, if desired, catheter shaft 100 lead 300 that can get loose simply is retained in treatment position with implant 95, and lead 300 from the implant 95 of this configuration to proximal extension.The advantage of this method is that if need to obtain again implant 95 afterwards, lead 300 will make it possible to easily arrive the implant 95 of this configuration.This performance of removing implant 95 in the patient body is a significant advantage of the present invention.
In addition, there is the near-end that allows the medicated cap (not shown) is rotated and is installed to implant 95 from implant 95 to the exposed lead 300 of proximal extension.This medicated cap can be used for providing for implant 95 at least some of terminal and sealing implant 95 inside of low-wound, thereby reduces agglomerative probability or the like.
Should be appreciated that above-mentioned implant 95 is included in a preferred form of the prolate body 157,184 described in No. the 10/446470th, the aforesaid U.S. Patent application.Like this, can also recognize, implant 95 can dispose (for example direct inwall with respect to coronary sinus) separately, and perhaps it can be configured to combine with aforesaid any other equipment that is connected with prolate body 157,184, and it can be configured to combine or the like with steady rest.
In this respect, it should also be appreciated that with a plurality of littler rods (for example above-mentioned stretching excellent 180,211) replaces the rod (for example at the prolate body 157,184 described in No. the 10/446470th, the aforementioned U.S. Patent application) of a relatively large diameter to have significant advantage.More particularly, see Figure 24 now, wherein show the sketch map of the mutual relation between expression excellent diameter (A or B), cross section profile (CP), peak hardness (SF) and the peak stress (ST).As used herein, term " cross section profile " is used for the indication equipment cross section.More particularly, when when having that more the bar of spillikin diameter B replaces excellent diameter to be the single bar of A, reducing the cross section profile (CP) of implant, increase the peak hardness (SF) of implant and reduce this peak stress (ST) with a plurality of.Thereby the combination rod implant that is formed by a plurality of spillikins of the present invention has significant advantage with respect to the excellent implant that the clavate by single relatively large diameter becomes.
It should also be appreciated that implantation equipment formed according to the present invention has provided a plurality of parameters that can be regulated by the doctor, thereby produce different stretching power, thereby and obtain optimum result.These parameters comprise: the implant position in (1) anatomical tissue, the excellent position that (2) implant, (3) excellent length, the hardness of (4) excellent hardness and (5) whole implant.
Will be appreciated that, because Annuloplasty equipment 90 can be formed with multiple different configuration, so Annuloplasty equipment 90 can be used for multiple different purpose.For example in a form of the present invention, Annuloplasty equipment 90 can be used as the independent use of diagnostic device and regains fully when process finishes.Perhaps, in another form of the present invention, complete Annuloplasty equipment 90 can be retained in the original place when process finishes.In these cases, owing to the cost reason, can wish to form Annuloplasty equipment so that make implant 95 and catheter shaft 100 form as one (for example by molded).In another form of the present invention, Annuloplasty equipment 90 can form and make and only implant 95 is retained in treatment site and regains the remainder of this equipment when process finishes.In this case, can wish implant 95 is separated formation with catheter shaft 100, and during disposing, they be combined releasedly, thereby when process finishes, be retained in implant 95 in the coronary sinus and regain the remainder of this equipment.
In many situations, be important with this equipment of fluid flushing.This can be used to eliminate air slide, and contrast medium perhaps is provided, and perhaps is used for some other purpose.In this case, see Figure 25 now,, can wish the far-end of two or more inner chambers is connected with one or more connector components 305, thereby form closed flow path in order to reduce in the patient body, to introduce the probability of allochthon.In this sense, implant 95 separates formation with catheter shaft 100, thereby make fluid must flow to the work inner chamber 170 in the implant 95 from the work inner chamber 205 the catheter shaft 100, it is important that the fluid-tight connection between implant 95 and the catheter shaft 100 is provided.
If desired, treatment part 120 can be formed with circular cross-section (for example shown in Figure 6) along its length, and perhaps it can have the cross section that varies along its length.Mode by example rather than restriction, if desired, treatment part 120 can have circular cross-section (Figure 26) at its far-end 150, is rectangle or trapezoid cross section (promptly in the zone that is close to mitral P2 lobule) in its mid-length, is flat relatively cross section (Figure 27) at its near-end 155.In addition, have under the situation in the cross section that is not circular in treatment part 120, if desired, during being inserted into operative site, treatment part 120 can be restricted to circular configuration, so that assist to make the treatment part by the patient's blood vessel system.This can remove that (Figure 28) realizes in the sleeve pipe 310 by a treatment part 120 is encapsulated in, and wherein in case treat part 120 and be set at operative site and just can remove this sleeve pipe 310, thereby allows treatment part 120 its expected structures of employing.
Figure 26-28 also shows, and if necessary, how the inner chamber that extends in treatment part 120 all has identical diameter.
As mentioned above, implant 95 can be configured to combine with steady rest, for example disclosed the sort of steady rest in No. the 10/446470th, aforementioned U.S. Patent application.This steady rest can help distributing equipment load on the wall of coronary sinus, with the core that helps stable treatment part 120 with respect to vertically moving (yet, to recall generally and be preferably, permission owing to insert the needs that stretching rod adopts more straight structure, makes the far-end of this equipment and near-end slide on this anatomical tissue according to this equipment).In addition, if desired, the part of the outer surface of treatment part 120 can comprise the structure 315 (Figure 29) that is used for the facilitate tissue growth, thereby the core that further will treat part 120 is anchored in the coronary sinus.By the mode of example rather than restriction, the outer surface of treatment part 120 can have morphology irregular or " bluring ", and/or it can scribble tissue growth promoter etc.In a preferred form of the present invention, structure 315 comprises the transplanting parts, and it is preferably made by the Dacron/Teflon mixture, anchors on the Teflon body of treatment part 120 and has high stretch and a high endotheliazation characteristic.
The passageway system
See Figure 30 and 31 below, wherein show a preferred Annuloplasty equipment 90, it is arranged such that reentering " passageway " extends downwardly in the implant 95 when this implantation process finishes.At last, (i) Annuloplasty equipment 90 preferably includes " individual unit " structure, wherein treating the near-end 155 of part 120 and the far-end 195 of catheter shaft 100 forms as one each other, (ii) Annuloplasty equipment 90 tends to enter the patient's blood vessel system by subclavian vein, (iii) in the end of this implantation process, cover the near-end of catheter shaft with medicated cap 320, be fixed to then in " bag " that under skin, forms, as hereinafter going through.
More particularly, in this form of the present invention, the mode that Annuloplasty equipment 90 is preferably with previous discussion is configured on the lead, thereby make its end portion 115 extend downwardly among the AIV, treatment part 120 is configured in the coronary sinus with mitral back lobule contiguous, and catheter shaft 100 extends through the right atrium of heart, upward to superior vena cava, in a subclavian vein, the sidewall from this subclavian vein comes out then.In a preferred form of the present invention, Annuloplasty equipment 90 has the diameter of about 7French.
Preferably, Annuloplasty equipment 90 extends through bracing frame 325, and this bracing frame 325 is set in the coronary sinus and near this Annuloplasty equipment of sliding support crown atrium 45.This bracing frame 325 can be disclosed the sort of in No. the 10/446470th, aforementioned U.S. Patent application.Alternatively, this bracing frame 325 can be any other suitable design, and it helps to distribute the load of Annuloplasty equipment 90 on the sidewall of coronary sinus, and allows Annuloplasty equipment 90 to slide with respect to this bracing frame.Annuloplasty equipment 90 comprises also that preferably tissue growth zone 315 is anchored in the coronary sinus with the core that helps to treat part 120, and can be included in anticorrosive sleeve or the grafting device 330 of the far-end of treatment part 120 around Annuloplasty equipment 90.
According to above stated specification,, just be inserted in the work inner chamber 205,170 so that reconfigure patient's anatomical tissue and reduce mitral incompetence stretching excellent 180 in case Annuloplasty equipment 90 has been set correctly in coronary sinus.
Be configured in the work inner chamber 170 with the anatomical tissue that reconfigures patient and after reducing mitral incompetence with stretching excellent 180, tubulose vibration damping coil 335 (Figure 31) or other suitable equipment can be advanced to downwards in the work inner chamber 205 filling work inner chamber 205, thereby and guarantee that stretching excellent 180 keep static in work inner chamber 170.In this regard, stretching excellent 180 also comprise aforesaid stretching lead 260 (Figure 18), and these stretching leads can extend through the inside of tubulose vibration damping coil 335.
Alternatively, be fixed under the situation of push rod 215 (for example shown in Figure 17) stretching excellent 180, vibration damping coil or like device typically will be unessential, because push rod 215 will play the effect identical with the vibration damping coil, promptly they will be filled work inner chamber 205 and guarantee on stretching excellent 180 positions that remain in the work inner chamber 170.
In this point, the near-end of catheter shaft 100 is stored in " bag " in patient's trunk.More particularly, the near-end of catheter shaft 100 is cut certain size (if desired), covers with medicated cap 320, is stored in then in this tissue bag.If desired, medicated cap 320 can be simple " individual unit " medicated cap, perhaps more preferably, medicated cap 320 can comprise that interior medicated cap 340 (comprises and is used for keeping stretching leads 260 and vibroshock 335 strip of paper used for sealing 345 and stopper 350 in place with respect to interior medicated cap 340, perhaps alternatively, comprise push rod 215, wherein stretching excellent 180 are fixed on the push rod 215) and outer medicated cap 355 (be used on the whole rear end of Annuloplasty equipment, forming and simply be slidingly matched).Preferably, outer medicated cap 355 comprises that the profile of low-wound is to reduce patient's any discomfort.
This " passageway system " embodiment has a plurality of remarkable advantages.Wherein, by the passageway that enters easily that arrives implanted equipment is provided, if wish to regulate the tissue reconstruction degree subsequently, just can realize at an easy rate, for example by opening this tissue bag to enter the far-end of Annuloplasty equipment, remove outer medicated cap 355, medicated cap 340 in removing is removed tubulose vibration damping coil 335, utilizes stretching lead 260 to remove stretching excellent 180, install alternate stretching excellent 180, reinstall tubulose vibration damping coil 335 and cover this equipment again (perhaps being fixed under the situation of push rod 215 stretching excellent 180, by opening this tissue bag to enter the far-end of Annuloplasty equipment, remove outer medicated cap 355, medicated cap 340 in removing is removed tubulose vibration damping coil 335, utilizes push rod 215 to remove stretching excellent 180, by push rod 215 install alternate stretching excellent 180 and cover this equipment again).Alternatively, by the passageway that enters easily that arrives implanted equipment is provided, if necessary, can in the patient body, remove this entire equipment subsequently, promptly by opening this tissue bag to enter the far-end of Annuloplasty equipment, remove outer medicated cap 355, medicated cap 340 in removing, remove tubulose vibration damping coil 335, utilize stretching lead 260 to remove stretching excellent 180, (perhaps, be fixed under the situation of push rod 215, by the remainder of removing this Annuloplasty equipment to the near-end stretching at the near-end of catheter shaft 100 then by opening this tissue bag to enter the far-end of Annuloplasty equipment stretching excellent 180, remove outer medicated cap 355, medicated cap 340 in removing, it is stretching excellent 180 to utilize push rod 215 to remove, and stretches to near-end by the near-end in catheter shaft 100 then and removes the remainder of this Annuloplasty equipment).
In addition, by a kind of Annuloplasty equipment 90 is provided, it comprises and near-end size (i.e. cutting) is set being assemblied in " individual unit " structure in the tissue bag according to needing in using, thus the problem of simplified apparatus dimensioned (and corresponding inventory problem) greatly.
Below 32-38 with the aid of pictures, wherein show another preferred form of Annuloplasty equipment 90.In this structure, implant 95 forms as one (seeing Figure 32-34 and 36) with catheter shaft 100, and stretching excellent 180 are fixed on the push rod 215 and (see Figure 38).In addition, catheter shaft 100 is formed with three work inner chambers 205 (Figure 35), and implant 95 is formed with three work inner chambers 170 (not shown in Figure 32-38).This structure 315 is used for the core and the facilitate tissue growth of grappling treatment part 120, and it can form (Figure 32-34 and 36) by stitching thread or other singles that is spirally wound on treatment part external surface peripheral.If desired, can form increaser 400 (Figure 38) on the bar of push rod 215 to aid in demonstration under the fluoroscopy.The near-end of medicated cap 500 closes ducts bars 100.
The equipment of Figure 32-38 preferably uses " passageway " method.More particularly, Annuloplasty equipment 90 preferably is incorporated in the patient's blood vessel system and is advanced in the coronary sinus by subclavian vein.Then, one or more stretching excellent 180 be inserted in the work inner chamber 205,170 with the anatomical tissue of rebuilding patient and reduce mitral incompetence.Then, use the near-end of medicated cap 500 these Annuloplasty equipment of sealing.Near-end with Annuloplasty equipment 90 is arranged in the tissue bag then.Then, if Annuloplasty equipment 90 needs to regulate (for example by increase, remove or change one or more stretching excellent 180), can enter this system once more by this tissue bag and medicated cap 500.
Use Annuloplasty equipment to combine with electric wire
Also may use the Annuloplasty equipment of novelty of the present invention to combine, for example be used for the electric wire of implantable two ventricle pace-making equipment and/or be used for electric wire of implantable cardiac defibrillator etc. with electric wire.This method is very favorable because these electric wires can be placed in the anatomic passages identical with Annuloplasty equipment 90 jointly, promptly from conventional blood vessel in-position (for example left subclavian vein 25) to AIV 60.
By the mode of example rather than restriction, in a preferred form of the present invention, one or more electric wires are pushed downwards and enter in the coronary sinus, down among the AIV and enter in the correct tissue.In case these are all finished, just lead 110 is advanced in the coronary sinus.Alternatively, can before these one or more electric wires, lead 110 be advanced in the coronary sinus.Work inner chamber by passing through alignment on the near-end of this lead is to 170,205 then, and the work inner chamber by passing through alignment in these one or more electric wires each is to 170,205 (perhaps other inner chambers auxiliary lumen of for example aliging is to 175,210), and be loaded into Annuloplasty equipment on this lead and these one or more electric wires on.Then Annuloplasty equipment 90 is advanced to far-end along this lead and one or more electric wire.In case Annuloplasty equipment 90 is advanced to the tram in the coronary sinus, just install stretching excellent 180 as discussed.
For example referring to Figure 39, wherein show the electric wire 600. that the far-end at this Annuloplasty equipment stretches out
Alternatively, in another preferred form of the present invention, can use electric wire that this Annuloplasty equipment is inducted on the position in the coronary sinus, can omit this lead in a word.More particularly, utilize this form of the present invention, for the first time one or more electric wires are advanced to downwards in the coronary sinus, down among the AIV and enter in the correct tissue.Work inner chamber by passing through alignment on each the near-end in these one or more electric wires advances along these one or more electric wires Annuloplasty equipment 90 then to 170,205 (perhaps other inner chambers auxiliary lumen of for example aliging is to 175,210) and Annuloplasty equipment is loaded on these one or more electric wires to far-end then.In case Annuloplasty equipment 90 is set correctly in the coronary sinus, just install stretching excellent 180 as discussed.
Certainly, can recognize, when when this one or more electric wire is set, being increased in the inner chamber quantity that provides in this Annuloplasty equipment at the inner chamber that may need to be used for other purposes (the work inner chamber of alignment that for example may need to be used to hold stretching rod is to 170,205).It is also envisioned that, when electric wire and stretching rod all must be accommodated in the same inner chamber, can provide this stretching rod by the inner chamber of himself, and can be on this electric wire this stretching rod of coaxial loading.
In another preferred form of the present invention, can advance one or more electric wires to advance the Annuloplasty equipment of previous setting that passes.More particularly, utilize this form of the present invention, be set in the coronary sinus in case cross Annuloplasty equipment, just advance one or more electric wires to pass inner chamber in this Annuloplasty equipment, pass the terminal of this Annuloplasty equipment then and enter in the correct tissue.In this form of the present invention, can or use as previously discussed stylet to transport on lead Annuloplasty equipment 90 is transported in the coronary sinus.
And it is in another form of the present invention, can be with one or more electric wires embedded or be installed in advance in the Annuloplasty equipment.In this structure, this Annuloplasty equipment and electric wire can be installed in the patient body simultaneously.
According to this description, those skilled in the art can understand this novelty Annuloplasty equipment of use and bonded other modes of electric wire.
Revise
Will be understood that those skilled in the art can be for describing in order to explain the present invention's essence and illustrative details, material, step and modular construction are made many other changes in claims in represented the principle and scope of the present invention here.

Claims (26)

1. device that is used to reduce mitral incompetence, this device comprises:
The elongate carrier of making by enough flexible materials, so that first structure that structure roughly is consistent with coronary sinus when being inserted into this carrier in the coronary sinus, with with box lunch to the second more straight structure of the described carrier of second structure bias voltage time structure, this carrier has a plurality of inner chambers of longitudinal extension therein; With
A plurality of stretching rods of holding by the inner chamber in this carrier of being suitable for, each stretching rod is formed:
(i) organize harder than anatomy around posterior mitral leaflet; With
(ii) have the shape more straight than near the shape of the coronary sinus the posterior mitral leaflet; With
(iii) has the length enough with respect to the radius of curvature of this coronary sinus;
Thereby when this stretching rod be set in the inner chamber and this carrier be set at coronary sinus in posterior mitral leaflet when adjacent, this stretching rod will apply stretching power to the wall of coronary sinus, thus moving forward the back ring engages to improve lobule, thereby and reduce mitral incompetence;
Wherein the size of at least one inner chamber is set to hold electric wire therein.
2. device as claimed in claim 1, wherein this carrier at least a portion is a circular cross-section.
3. device as claimed in claim 1, wherein this carrier at least a portion is an oval cross section.
4. device as claimed in claim 1, wherein this stretching rod provides the hardness of variation along its length.
5. device as claimed in claim 1, wherein this stretching rod is to select from the group that comprises a plurality of rods with different hardness.
6. device as claimed in claim 1, wherein this stretching rod is to select from the group that comprises a plurality of rods with different length.
7. device as claimed in claim 1, wherein this device also comprises lead, and this carrier also comprises opening, wherein lead can move in this opening.
8. device as claimed in claim 7, wherein this opening comprises in this inner chamber one.
9. device as claimed in claim 8, wherein this inner chamber has different diameters.
10. device as claimed in claim 8, wherein said a plurality of stretching rods comprise the first stretching rod and the second stretching rod, the described first stretching rod has and the different hardness of the described second stretching rod.
11. device as claimed in claim 10, wherein the hardness of this first stretching rod along the hardness of its at least a portion and this second stretching rod along its at least a portion cooperates in the mode of contrary.
12. device as claimed in claim 1, wherein this device also comprises the sleeve pipe that is used to comprise described carrier, and described sleeve pipe can be removed from described carrier.
13. device as claimed in claim 12, wherein this sleeve pipe is restricted to first cross-sectional structure with this carrier, and when removing sleeve pipe, discharges this carrier to become second cross-sectional structure.
14. device as claimed in claim 1, wherein this stretching rod is straight basically under unstress state.
15. device as claimed in claim 1, wherein this stretching rod is crooked in being inserted into coronary sinus afterwards.
16. device as claimed in claim 1, wherein this stretching rod comprises first and second ends that link together by mid portion, wherein this mid portion comprises first and second zones that link together by the central area, wherein after this elongate carrier is inserted in the coronary sinus, this central area and first and second ends are crooked, and wherein after this elongate carrier was inserted in the coronary sinus, this first and second zone was straight basically.
17. device as claimed in claim 16, wherein this first and second zone is harder than the central area, and wherein this central area is harder than first and second ends.
18. device as claimed in claim 16, wherein this central area, first and second ends and first and second zones have certain-length, so that this elongate carrier applies forward power to the wall of coronary sinus near posterior mitral leaflet, and wherein with the Bicuspid valve junction near the wall of this coronary sinus is applied backward power.
19. device as claimed in claim 1, wherein this stretching excellent at least a portion is formed by elastomeric material.
20. device as claimed in claim 1, wherein this stretching rod is rebuild Bicuspid valve on continuous foundation in the time cycle of a prolongation.
21. device as claimed in claim 1, wherein this stretching excellent at least a portion is formed by highly elastic material.
22. device as claimed in claim 1, wherein this device also comprises the steady rest that is engaged to described elongate carrier.
23. device as claimed in claim 1, wherein at least a portion of this elongate carrier is configured to the facilitate tissue growth.
24. device as claimed in claim 1, wherein this device also is included in the electric wire that extends in the inner chamber.
25. device as claimed in claim 24 wherein was arranged on this electric wire in this inner chamber before being arranged on this elongate carrier in the patient body.
26. device as claimed in claim 24 wherein is arranged on this electric wire in this inner chamber after this elongate carrier being arranged in the patient body.
CN2005800469140A 2004-11-24 2005-11-23 Method and apparatus for improving mitral valve function Expired - Fee Related CN101443073B (en)

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US60/630,606 2004-11-24
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EP1827581A2 (en) 2007-09-05
WO2006058163A3 (en) 2006-12-14
JP2008521501A (en) 2008-06-26
CN101443073A (en) 2009-05-27
CA2588653A1 (en) 2006-06-01
WO2006058163A2 (en) 2006-06-01
WO2006058163A9 (en) 2008-12-11

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