CN104055600B - A kind of repair system for stoping valvular regurgitation with anchoring device - Google Patents
A kind of repair system for stoping valvular regurgitation with anchoring device Download PDFInfo
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- CN104055600B CN104055600B CN201410316922.3A CN201410316922A CN104055600B CN 104055600 B CN104055600 B CN 104055600B CN 201410316922 A CN201410316922 A CN 201410316922A CN 104055600 B CN104055600 B CN 104055600B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
Abstract
The present invention relates to a kind of repair system for stoping valvular regurgitation with anchoring device, comprise the prosthese and anchor log releasing device that stop valvular regurgitation, the prosthese of valvular regurgitation is stoped to comprise fixed cell, connector and help closing member, fixed cell comprises fixture and anchor log, described connector is flexible, fixture is fixed by anchor log, and the near-end of described anchor log is provided with anticreep end, described anchor log releasing device comprises carrier pipe and push rod, anchor log releasing device and fixed cell removably connect, the distal portions of described anchor log releasing device has default shape, make the distal portions of carrier pipe can integrally bending or bend portions, the distalmost end of carrier pipe is provided with rigid section, anchor log is pre-filled with in the distal portions of carrier pipe, push rod is placed in carrier pipe, be positioned at the near-end of anchor log, promoting push rod can make anchor log move to the far-end of carrier pipe, after anchor log is pushed out carrier pipe, its distal portions can reply the shape preset.
Description
Technical field:
The invention belongs to medical instruments field, being specifically related to a kind of repair system for stoping valvular regurgitation with anchoring device.
Background technology:
Mitral position is in left atrioventricular orifice, connected five parts formed by lobe ring, lobe leaf, chordae tendineae, papillary muscles, boundary, its exact name is anatomically Mitral valve structure (mitralapparatus) or mitral complex (mitralcomplex).
Tricuspid valve is positioned at right atrioventricular orifice, there are three subtriangular sail valves, be attached at the bottom of valve in the fibrous ring of atrioventricular orifice, functionally visual fibrous ring, valve, chordae tendineae and papillary muscles, be tricuspid complex (tricuspidvalvarcomplex).
Mitral incompetence (mitralregurgitation) can be divided into following three kinds: functional, degeneration and Combination.Modal is degeneration and functional mitral regurgitation.Functional being generally is secondary to that left ventricular wall motion function is impaired, left ventricular dilatation, papillary muscle dysfunction, generally sees in heart failure patient.This part patient also comprises the Ischemic Mitral Regurgitation that is secondary to coronary heart disease and the relevant mitral incompetence of Nonischemic cardiolmyopathy.Degeneration mitral incompetence disease is generally considered to be the change of valve structure generation pathologic, or under valve, structure pathologic changes, and the exception comprising chordae tendineae extends or fracture.The detailed cause of disease of mitral incompetence can be divided into: 1. coronary atherosclerotic heart disease (coronary heart disease): after myocardial infarction and chronic myocardial ischemia involve papillary muscles and contiguous locular wall cardiac muscle thereof, cause papillary muscles fibrosis to accompany dysfunction; 2. congenital malformation: mitral valve cleft lacks, is most commonly in endocardial cushion defect or the transposition of correction type heart, endocardial fibroelastosis, landing umbellate form Bicuspid valve deformity; 3. mitral annular calcification: be idiopathic degeneration, be more common in old women patient.In addition, hypertension, marfan's syndrome, also easily there is mitral annular calcification in chronic renal failure and the hyperthyroid patient of Secondary cases; 4. left ventricle dilation: the obvious left ventricle dilation that any cause of disease causes, all can make annulus of mitral valve expand, and papillary muscles sidesway, affects the closed of lobe leaf, thus causes mitral incompetence; 5. mitral valve prolapse syndrome; 6. other rare causes of disease: connective tissue disease as systemic lupus erythematosus (sle), rheumatoid arthritis etc.; Hypertrophic obstructive cardiomyopathy; Tetanic sclerosing myelitis.For mitral incompetence, at the U.S. and western developed country, mucus degeneration causes in the highest flight, and about 45% ~ 65%, and rheumatic lesion is still the main cause of many developing countries mitral lesion, accounts for 80%.
Tricuspid regurgitation is generally pulmonary hypertension, and right ventricle expands, and tricuspid annulus expansion causes, after there is tricuspid regurgitation, and the right heart failure exacerbation of symptoms such as weak, ascites, edema, hepatalgia, dyspepsia, poor appetite.Tricuspid incompetence is mainly divided into functional tricuspid insufficiency and organic tricuspid incompetence.The organic insufficiency of the valve caused by rheumatic fever is that number is little, majority is functional incompetence, its modal cause of disease causes right ventricle to expand by pulmonary hypertension, and tricuspid annulus expands, and this body structure of valve is normal relative to incompetence to cause Tricuspid valve.
The traditional treatment means of mitral incompetence and tricuspid regurgitation comprise and being applicable to slightly to the Drug therapy of severe reflux, and have the surgical method of corresponding surgical indication.Wherein, surgical method also comprises Bicuspid valve, replacement of tricuspid valves and Bicuspid valve, Tricuspid valve is repaired.Simple mitral incompetence, needs the patient of mitral valve replacement to only have 30%, and remaining only needs mitral valve repair.In surgical method, typically open breast, open heart operation invasive is excessive, need to set up extracorporeal circulation, there is higher complication rate and infection risk.And in order to reduce operation risk, developed through the displacement of intubation intervention and repairing operation method.
According to document [Enriquez-SaranoM, SchaffHV, OrszulakTA, etal.Valverepairimprovestheoutcomeofsurgeryformitralregu rgitation:amultivariateanalysis [J] .Circulation, 1995,91 (4): 1022-1088] report visible replacement and there is higher total operation case fatality rate and lower survival rate.
Comparing (multicenter) of table 1. plastic surgery for mitral valve and mitral valve replacement postoperative mortality and complication
And transcatheter therapy valvular regurgitation, current problem demanding prompt solution following points: as far as possible under the prerequisite ensureing resistance reflux effect, reduce the implantation amount of implant; The apparatus of resistance reflux must be accurately positioned and fixedly secure at the position needing treatment; The apparatus of resistance reflux needs the impact of minimum degree to remain the motion with the lobe leaf of normal function; The apparatus of resistance reflux needs the diversity of the physiological structure adapting to lobe ring, lists below in currently available technology, different resistance reflux apparatuses and the technical essential of anchoring techniques.
Patent WO2006037073A2 describes a kind of Therapeutic Method using Bicuspid valve folder (mitralclip) to carry out mitral valve repair, the center of mitral valve or corner regions are stitched together, but this technology cannot be applied to following two class patients: gaping of joints > 10mm between systole lobe leaf, cannot accurate synchronization two lobe leaves movable; Another kind is that the structure under lobe ring has and seriously thickens and calcification, because of the raising of chordae tendineae, lobe leaf, lobe ring compression, has the risk of rupture of chordae tendineae.
Patent US20130023985 describes a kind of implant being used for the treatment of valvular insufficiency and other valve disease, implant system and method, described implant comprises an auxiliary lobe leaf conjugant, the fit length of autologous lobe loop section of described lobe leaf conjugant top is 25-35mm, equal the distance between the first and second associating intersections, described lobe leaf conjugant top is to lower length 50-60mm, and selectablely on described lobe leaf conjugant be provided with anchoring device, in its claim, also limit certain part of described conjugant for conical, in another claim, be 25-35mm except limiting described top autologous lobe loop section length of fitting, the height also defining described lobe leaf bonding part and lobe ring vertical direction is 35-45mm, defining ventricle non-bonding part is being 25-35mm with the height in lobe ring vertical direction, define bonding part radius of the radian within 35-45mm.This kind of system is fitted for top the length restriction of autologous lobe loop section, be only applicable to the entirety reparation of anterior mitral valve or back lobe prolapsus, and the prolapsus reparation of the tricuspid global section leaf of part, and show that described conjugant lower length covering at least most of lobe leaf, described bound fraction has specific radian requirement.This kind of technology cannot adapt to the reparation of the prolapsus of valve fraction or less valve such as aortic valve, when repairing the position of incompetence, sacrifices the valve that all the other normally work simultaneously.
And in patent CN103338726A, describe a kind of method that joint being used for the treatment of patient's heart valve is bad, described method is included in when implant is in the first configuration to be introduced in heart by described implant, described implant is launched into the second configuration from described first configuration in heart, the described implant being in described second configuration has the joint auxiliary body of the first and second contrary composition surfaces, and support that the implant of described expansion makes described joint auxiliary body along described bonding land from described valvular described journal offset, in its claim, described method also comprises: optionally configure the first anchor log in the first object position near described first associating (described first combines the first junction for the first and second lobe leaves had at described cardiac valve), the second anchor log is optionally configured in the second target location near described second associating (described second combines the second junction for the first and second lobe leaves had at described cardiac valve), to engage auxiliary body introduces in heart, in another claim, describe described implant and comprise joint auxiliary body, first anchor log and the second anchor log, described joint auxiliary body has axis and the first and second contrary main composition surfaces, the horizontal expansion between first transverse edge and the second transverse edge of described joint auxiliary body of each composition surface, described first anchor log is optionally configured in the first object position of the heart near described first associating, make described first transverse edge towards described first united directional, thereafter place is being combined near described second in the anchor station also defining described second anchor log.In another claim, the axis being also particularly limited to described implant need along described valve Axis Extension, and the first and second sides of described joint auxiliary body need along the curve extension of described valvular bonding land, wherein fully laterally conformal by the described joint auxiliary body of the implant supported, the curve transverse curvature that the joint between described implant and heart makes the described joint auxiliary body between described edge limit towards described valvular bonding land.The claims, define described anchor station and be required to be and combine place near described first and second, also defining whole described joint auxiliary body need be fully laterally conformal with described cardiac valve.This kind of technology, cannot adapt to the valve prolapse disease of part, while performance resistance reflux effect, there are two shortcomings, the first, cover the normal valve do not prolapsed, in long-term motor process, easily cause adhesion, sacrifice the normal function running of part normal valve, second, in the autologous lobe leaf part near autologous lobe ring place, in opening and closing process, motion amplitude is less than the motion amplitude of the lobe leaf part at close lobe point place, easy and conformal by abundant transverse direction and the described cardiac valve auxiliary body be affixed with it sticks together, be different from described upper bond auxiliary body and lobe ring place herein, at described lobe ring place, in long-term implantation process, together with implant should grow with described autologous lobe ring, increase the effect be fixed, and the autologous lobe leaf part at described close autologous lobe ring place, once cause adhesion, the movement effects of lobe leaf can be affected, easily cause secondary reflux, cause resistance reflux Endodontic failure, 3rd, because each one size of autologous lobe ring is different, cause product specification in this technology more.
Patent US20130325110A1 describes the conveying of a kind of beating heart and helps lobe leaf to close the treatment Bicuspid valve of prosthese and the method for tricuspid regurgitation, described method comprises and utilizes flexible rail, ventricle fixture is sent into right ventricle from atrium through native valve and carries out grappling, utilize conduit to carry and adjust the position of described prosthese in tricuspid annulus, until make reflux reduce, by relative with described flexible rail for described conduit fixing, and be fixed on postcava.Though this kind of carrying method can regulate the position of described prosthese to adapt to different reflux positions, there is certain pathological changes adaptability, but described in inferior caval fixed position away from lobe ring position, easily cause fixing insecure, prosthese displacement after fixing.
Patent US2005107811A1 and US2008058868A1 describes a kind of anchoring system and carrying method thereof, adopt the anchor pin that marmem is made, this anchor needle set has both feet, both feet are turned to same direction and are intersected, form a closed hoop, this anchor pin is furnished with expansion component and transfer member, and these two parts can be changed mutually, in operation process, anchor pin is discharged from transfer member, make marmem self-expanding enter expansion component, thus make anchor pin both feet can penetrate tissue along anchor pin direction of a curve, carry out tissue and fix.This kind of anchoring system and carrying method thereof, the power that only use only marmem itself penetrates tissue, for such as part with the position that penetrates of the toughness tissues such as endocardium, there is the power of penetrating inadequate, easily penetrating slippage in process, penetrating rear fixing shakiness, the problem such as easily come off.
Current clinical effectiveness shows, does not have the product of a desirable treatment valvular regurgitation.Main cause is that mitral annulus, Tricuspid annulus etc. have special physiological structure, and below lobe ring, have complicated physiological environment, causes product accurately to locate and fixes very difficult.In addition, the degree of valve prolapse pathological changes is different from position, such as some patients to prolapse the incompetence caused for back lobe, the incompetence etc. that some patients causes for associating lobe pathological changes, the above technology is while the incompetence for the treatment of lesion locations, also interfere with the normal mitral physiological structure of residue, pathological changes adaptability is not enough, and above-described anchoring techniques, the standard that can not reach ease of Use and fixedly secure, in sum, although technology described above has certain effect respectively in valve repair, but, in the field of surgery for the treatment of valvular insufficiency, needing one badly, to possess position adjustable simultaneously, accurate positioning, during grappling and apparatus no-float, easy and simple to handle, and can tackle various in various degree with the technology of position pathological changes.
Summary of the invention:
The object of the invention is the restriction overcoming prior art, prolapse for valve member, a kind of repair system for stoping valvular regurgitation with anchoring device is proposed, the present invention can realize that position is adjustable, accurate positioning and secure anchorage, can according to various in various degree with the pathological changes of position, regulate prosthese position, then to position and grappling, simultaneously not easily with patient's lobe ring near tissue adhesion.
The object of the invention is to be achieved through the following technical solutions:
A kind of repair system for stoping valvular regurgitation with anchoring device, comprise the prosthese and anchor log releasing device that stop valvular regurgitation, the prosthese of described prevention valvular regurgitation comprises fixed cell, connector and help closing member, described fixed cell comprises fixture and anchor log, the distal portions of described connector is connected with the proximal part of described fixture, the proximal part of described connector is connected with the described distal portions of closing member that helps, described connector is flexible, make described connector and help closing member can move along with the motion of lobe leaf described in being attached thereto, described fixture is fixed in patient's atrial walls or on lobe ring by described anchor log, describedly help closing member when free state between autologous patient lobe leaf, the distal portions of described anchor log has default shape, the near-end of described anchor log is provided with anticreep end, described anchor log releasing device comprises carrier pipe and push rod, described anchor log releasing device and described fixed cell removably connect, the distal portions of described anchor log releasing device has default shape, make the distal portions of described carrier pipe can integrally bending or bend portions, so that the distalmost end of described carrier pipe is tight against described fixed cell or is tight against autologous tissue before described anchor log is moved, the distalmost end of described carrier pipe is provided with rigid section, described anchor log is pre-filled with in the distal portions of described carrier pipe with extended configuration, described push rod is placed in described carrier pipe, described anchor log is positioned at the far-end of described push rod, promoting described push rod can make described anchor log move to the far-end of described carrier pipe, after described anchor log is pushed out described carrier pipe, the distal portions of described anchor log can recover its shape preset, the prosthese of described prevention valvular regurgitation is fixed between described autologous tissue and the described anticreep end of described anchor log by described anchor log.
Object of the present invention can also be realized further by following technical scheme:
Preferably, the part that described carrier pipe can bend is bending section, the distalmost end of described carrier pipe to the described bending section of described carrier pipe most proximal end between length be more than or equal to 1/6 of the girth of the circle done with the least radius of autologous patient valvular tissue ring (described native valve organizes the radius of ring to be defined as in lobe ring cross-wise direction, from lobe ring to the distance of lobe ring kernel of section).
Preferably, the width that described fixture launches is less than 2/3 of valvular tissue ring girth.
Preferably, the described Breadth Maximum of closing member that helps is less than the Breadth Maximum of single described autologous lobe leaf expansion.
Preferably, the described closing member that helps is monolithic, multi-disc, tubular, bag-shaped, column or sacculus, or described in help closing member to be the combination of monolithic and multi-disc, or described in help closing member to be the combination of monolithic and tubular, or described in help closing member to be monolithic and bag-shaped combination, or described in help closing member to be the combination of monolithic and column, or described in help closing member to be the combination of monolithic and sacculus.
Preferred, described in help closing member to be network, or described in help that to close sheet be macromolecular material sheet or animal derived material piece, when described help close sheet be macromolecular material sheet or animal derived material piece time, described help close sheet is arranged porose.
Preferably, described in help the near-end of closing member to be provided with expanding unit, described expanding unit is made up of tinsel or macromolecule line.
Preferably, described helping in closing member is connected with adjust structure, described adjust structure is tinsel or macromolecule line, help in closing member described in one end of described tinsel or described macromolecule line is connected to, the other end of described tinsel or described macromolecule line is connected on ventricle or the apex of the heart, by the distance between the two ends that adjust described tinsel or described macromolecule line, described in adjusting, help the effect of the resistance reflux of closing member.
Preferably, described anchor log is connected with described fixture, and removably connecting of described anchor log releasing device and described fixed cell is realized by described anchor log and described removably connecting of anchor log releasing device.
Preferred, described anchor log and described fixture are structure as a whole.
Preferably, help described the passage that there is between closing member and described fixture blood supply liquid stream and cross.
Preferably, described connector is lamellar, strip or thread, or described connector is the combination of said structure.
Preferred, described connector is arranged porose, described hole is the passage that blood flows through.
Preferred, described connector is by part overlay film, and described connector does not have the part of film to be the passage that blood flows through.
Preferred, when described connector be single strip or thread time, the both sides of described connector are the passage that blood flows through.
Preferably, described fixture is flexible high molecular sheet or macromolecule screen cloth, or described fixture has framing structure, described framing structure is that shape-memory material braiding is made or one cutting forms, and described framing structure is by part or by whole overlay film.
Preferably, the length of the described rigid section of described carrier pipe is more than or equal to 1/10th of the total length of described anchor log.Preferred, the length of the described rigid section of described carrier pipe is more than or equal to 1/2nd of the total length of described anchor log.
Preferably, the scheduled shape of distal portions of described carrier pipe, make the distal portions of described push rod can along with the distal portion bends of the scheduled shape of described carrier pipe, or the scheduled shape of the distal portions of described push rod, the described distal portions of described carrier pipe is bending with the shape of the scheduled shape of described push rod, or all scheduled shape of the distal portions of described carrier pipe and described push rod, makes the distal portions of described carrier pipe bend together with the distal portions of described push rod.
Preferred, described push rod is made up of one or more in shape-memory alloy wire, marmem pipe, macromolecular material rod or macromolecular material pipe, the scheduled shape of distal portions of described push rod, the distal portions of described carrier pipe is bending with the shape of the scheduled shape of described push rod.
Preferably, the described anticreep end of described anchor log extends coiling further by the near-end of described anchor log and is formed.
Preferably, the described anticreep end of described push rod and described anchor log removably connects.
Preferably, described band anchoring device for stoping the repair system of valvular regurgitation also to comprise bracing or strutting arrangement and bracing or strutting arrangement operating parts, described bracing or strutting arrangement operating parts is fixedly connected with the near-end of described bracing or strutting arrangement, the distal portions of described bracing or strutting arrangement can bend, after described bracing or strutting arrangement is released, the described distal portions of described bracing or strutting arrangement props up autologous tissue.
Preferably, described band anchoring device for stoping the repair system of valvular regurgitation also to comprise bracing or strutting arrangement and induction system, described induction system comprises seeker, outer sheath, sheath core and operating parts, described sheath core is arranged in outer sheath, the far-end of described sheath core is fixedly connected with described seeker, the near-end of described sheath core is fixedly connected with described operating parts, described heart valve prosthesis, described anchor log releasing device and described bracing or strutting arrangement are all arranged between described outer sheath and described sheath core, the near-end of described bracing or strutting arrangement is fixedly connected with the described operating parts of described induction system, or the far-end of described bracing or strutting arrangement is fixedly connected with the described seeker of described induction system, or the near-end of described bracing or strutting arrangement is fixedly connected with the described operating parts of described induction system and the far-end of described bracing or strutting arrangement is fixedly connected with the described seeker of described induction system, when described anchor log releasing device is released, described bracing or strutting arrangement gives described anchor log releasing device support force.
Compared with the existing technology, the invention has the advantages that:
1, be different from overall valve replacement technique, present invention preserves autologous lobe leaf and lobe leaf motor function, by helping closing member to prevent the upset of prolapsus lobe leaf, thus reach the object stoping valvular regurgitation, it is few that it has implant, and hemodynamics such as to learn well at the advantage.
2, the Breadth Maximum helping the Breadth Maximum of closing member to be less than single described autologous lobe leaf expansion of the present invention, described autologous lobe leaf had both comprised front and back lobe lobe leaf, comprise again associating lobe lobe leaf, the scope of application is wider than prior art, not only can avoid helping the wide impact on other adjacent petals leaf closing functions of closing member, and can carry out circumference adjustment make to help closing member to be placed on most suitable prolapsus position, not only implant is less, complication is low, and be adapted to the lobe ring size of different patients, indication is expanded, and manufacturer can reduce product specification.
3, push rod of the present invention is used to the motion controlling anchor log, when pushing, its thrust is in conjunction with the prosthese support force of described prevention valvular regurgitation, the active force of bracing or strutting arrangement described in described carrier pipe or preferred embodiment, the tube wall of the rigid section of the distal portions of described carrier pipe is to one or more in the restraint of described anchor log, make described anchor log by under the difformity preset, can successfully pushed enter toughness endocardium and endocardial tissue, compensate for the autologous power of penetrating of anchor log in prior art insufficient, successfully cannot penetrate the technological deficiency of endocardium and tissue, solve anchor log and locate not easily penetrating in process, easy slippage, penetrate rear fixing shakiness, under blood washes away, the problem such as easily to skid off, technology of the present invention adequately achieves the function of accurately location and secure anchorage.
4, the distal portions of anchor log releasing device of the present invention has default shape, make the distal portions of described carrier pipe can integrally bending or bend portions, ensure when described anchor log moves to the far-end of described carrier pipe, the far-end of described carrier pipe can offset vertical with toughness position of having an acupuncture treatment, and the distalmost end of described carrier pipe is rigid section, the far-end of described carrier pipe is made to be tight against autologous tissue, ensure the angle that anchor log penetrates, and restriction penetrates path, make described anchor log by under the difformity preset, successfully can be pushed into the tissue of malleable soft.
5, connector described in the present invention is flexible, makes described connector and helps closing member can move along with the motion of lobe leaf described in being attached thereto, and can not affect the motor function of autologous lobe leaf.
6, help described the passage that there is between closing member and described fixture blood supply liquid stream and cross in the present invention, the tissue near apparatus and patient's lobe ring can be avoided to stick together because of Long Term Contact.
7, fixture described in the present invention adopts the structure of non-closed loop (width that described fixture launches is less than 2/3 of valvular tissue ring girth), decreases the support force to atrial walls, avoids the impact on atrium and adjacent valve motor function.
8, preferred version of the present invention, is also provided with adjusting device, under Image-aided, can adjust the effect stoping lobe leaf reflux, until be fixed in during best results in the apex of the heart and ventricle wall by controlling adjusting device.
Accompanying drawing explanation
Fig. 1 a-1d is the principle schematic of a kind of repair system for stoping valvular regurgitation with anchoring device of the present invention, and wherein Fig. 1 c is the close-up schematic view of Fig. 1 b; Fig. 1 d be Fig. 1 c autologous lobe leaf open allow blood flow by time schematic diagram.
Fig. 2 a-2p is the structural representation of an embodiment of a kind of repair system for stoping valvular regurgitation with anchoring device of the present invention, and wherein Fig. 2 a-2b is the structural representation of described prevention valvular regurgitation prosthese; Fig. 2 c-2h is the structural representation of the preferred embodiment of anchor log of the present invention; Fig. 2 i-2k is the structural representation of the preferred embodiment of anchor log releasing device of the present invention; Fig. 2 l-2p is the structural representation of the preferred embodiment of carrier pipe of the present invention.
Fig. 3 a-3i is the operating process schematic diagram of a kind of repair system for stoping valvular regurgitation with anchoring device of the present invention.
Fig. 4 a-4m is structural representation and the operating process schematic diagram of another embodiment of a kind of repair system for stoping valvular regurgitation with anchoring device of the present invention, and wherein Fig. 4 a is the structural representation of described prevention valvular regurgitation prosthese; Fig. 4 b is the structural representation of described anchor log releasing device; Fig. 4 c-4h is the operating process schematic diagram of described repair system; Fig. 4 i-4j is the structural representation of the different angles of another preferred embodiment of described bracing or strutting arrangement; Fig. 4 k-4m is respectively the structural representation of three preferred embodiments of described bracing or strutting arrangement.
Fig. 5 a-5g be of the present invention a kind of with anchoring device for stoping the schematic diagram of the repair system of valvular regurgitation when being used to different parts disease, can along the circumference adjustment position of patient's lobe ring after described fixture launches, wherein Fig. 5 a-5d is the schematic diagram that described system is used to when treating mitral valve disorder; Fig. 5 e-5g is the schematic diagram that described system is used to when treating tricuspid valve disorder.
Fig. 6 a-6g is structural representation and the operating process schematic diagram of another embodiment of a kind of repair system for stoping valvular regurgitation with anchoring device of the present invention, and wherein Fig. 6 b is the partial enlargement structural representation of Fig. 6 a; Fig. 6 g is the partial enlargement structural representation of Fig. 6 f.
Fig. 7 a-7d is the structural representation of the preferred embodiment of anchor log of the present invention.
Fig. 8 a-8e is the structural representation of the preferred embodiment of the prosthese of prevention valvular regurgitation of the present invention.
Detailed description of the invention:
For making object of the present invention, technical scheme and advantage clearly understand, to develop simultaneously embodiment referring to accompanying drawing, the present invention is described in more detail.
The present invention is directed to the prosthese of described prevention valvular regurgitation, described far-end refers to the one end away from the apex of the heart, and described near-end refers to the one end close to the apex of the heart.The present invention is directed to described anchor log releasing device, described near-end refers to the one end near described anchor log releasing device operating parts or operator, and described far-end refers to the one end away from described releasing device operating parts or operator.
Specific embodiment one:
As shown in Figure 1a, a kind of repair system for stoping valvular regurgitation with anchoring device, comprises and stops the prosthese 1, four of valvular regurgitation to overlap anchor log releasing device 2 and induction system 3, is used for the treatment of the prolapsus of Bicuspid valve back lobe part.
As illustrated in figures 2 a-2b, the prosthese 1 of described prevention valvular regurgitation comprises fixed cell 11, connector 12 and helps closing member 13.Described fixed cell 11 comprises fixture 111 and two anchor logs 112, described fixture 111 is fixed on autologous patient tissue 4 by described anchor log 112, in the present embodiment, only in adjacent two cover anchor log releasing devices 2, be mounted with anchor log 112, the releasing device 2 not loading anchor log 112 is used as bracing or strutting arrangement, its distal portions is tight against autologous patient tissue after being released, give a whole set of described releasing device 2 support force, thus its enough counteracting force can be given in propelling movement anchor log 112 later stage, be convenient to anchor log 112 and penetrate patient's toughness tissue.The width of the expansion of described fixture 111 equals 1/3 of valvular tissue ring girth, described fixture 111 has and is woven and the framing structure made of heat setting by shaped-memory nitinol silk, it is coated with polymeric membrane, and is sewed with the netted dacron membrane of close weave at the two ends of described fixture 111, as shown in Figure 2 c, described anchor log 112 is made up of the shaped-memory nitinol silk of diameter 0.25mm, the distalmost end 1121 of described anchor log 112 is tip shape, the distal portions 1122 of described anchor log 112 is preheated and is shaped as arc, the near-end of described anchor log is provided with anticreep end 1123, described anticreep end 1123 is preheated the circle being shaped to diameter 1.1mm, described anchor log 112 is fixedly connected with position line 1124, described fixed form is for adopting metal canula clamping connection, as illustrated in figures 2 a-2b, the other end of described position line 1124, be fixed on described fixture 111, when in the distal portions that described anchor log 112 is pre-filled with described anchor log releasing device 2, the extended configuration of described anchor log 112 as shown in Figure 2 d, in a preferred embodiment, as shown in Fig. 2 e-2f, the anticreep end 1123 of described anchor log 112 extends pre-heat setting further by described distal portions 1122 and forms, described position line 1124 by solderless wrapped connection on described anticreep end 1123, in a further advantageous embodiment, as shown in Fig. 2 g-2h, the anticreep end 1123 of described anchor log 112 is made up of the scheduled dicyclo that formed of shape-memory alloy wire.As illustrated in figures 2 a-2b, described connector 12 is lamellar, be made up of polymeric membrane, for flexibility, the distal portions of described connector 12 is connected with the proximal part of described fixture 111, the proximal part of described connector 12 is connected with the described distal portions of closing member 13 that helps, and described connector 12 is arranged porose, and described hole is the passage 121 that blood flows through.In a preferred embodiment, the described closing member 13 that helps is the combination of monolithic and multi-disc, the described distalmost end of closing member 13 that helps is extended by the monolithic polymeric membrane of described connector 12, two panels is divided at the described middle part of closing member 13 that helps, the described proximal part of closing member 13 that helps is provided with expanding unit 131, described expanding unit 131 is made for shape memory titanium-nickel wire, be preheated setting, help described in described expanding unit 131 is fixed in closing member 13, across the described proximal part helping closing member 13, described in preventing, help closing member 13 wrinkling or compressed; Described helping in closing member 13 is connected with adjust structure 132, described adjust structure 132 is made up of high-molecule metal silk or macromolecule line, help on the near-end of closing member 13 described in one end of described adjust structure 132 is connected to, the other end of described adjust structure 132 is connected on ventricle or the apex of the heart, by adjusting the distance between described adjust structure 132 two ends, the effect of the resistance reflux of closing member 13 is helped described in can adjusting, as shown in Fig. 1 c-1d, described in help closing member 13 when free state part between autologous patient lobe leaf 7.In the present embodiment, described anchor log 112 and described fixture 111 are interconnected by position line 1124, and removably connecting of described anchor log releasing device 2 and described fixed cell 11 is realized with described removably connecting of anchor log releasing device 2 by described anchor log 112.
As shown in fig. 2i, described four cover anchor log releasing devices 2 comprise four cover carrier pipe 21 and four cover push rods 22, in a preferred embodiment, as shown in Fig. 2 j-2k, described anchor log releasing device 2 comprises three cover carrier pipe 21 and three cover push rod 22 (not shown).As shown in fig. 2i, described induction system 3 is made up of known technology, comprise Tip head (seeker) 31, sheath core 35, outer sheath 32 and operating parts 33,34, the far-end of described sheath core 35 is fixedly connected with described seeker 31, the near-end of described sheath core 35 is fixedly connected with described operating parts, proximal part 211 and 221 (not shown) of described carrier pipe 21 and described push rod 22, being fixedly connected on described operating parts 33 and 34 respectively, described carrier pipe 21 and described push rod 22 can being moved respectively by operating described operating parts 33 and 34.As shown in Fig. 2 l-2p, the distal portions 212 of described carrier pipe 21 can integrally bending or bend portions, the part that described carrier pipe 21 can bend is bending section 2121, the distalmost end of described carrier pipe 21 is provided with rigid section 2122, the length of described rigid section 2122 equals the total length of described anchor log, described bending section 2121 is for having the rustless steel pipeline section of joint-cutting, or the anti-broken pipe of macromolecule that described bending section 2121 strengthens for tinsel, and the internal diameter of described carrier pipe 21 is 1.0mm.The distalmost end of described carrier pipe equals 1/3 of the girth of the circle done for radius with the least radius r of autologous patient valvular tissue ring to the length of the most proximal end of the bending section 2121 of described carrier pipe 21, described least radius is defined as the cross-wise direction at lobe ring, from lobe ring to the beeline of lobe ring kernel of section.As shown in Figure 3 a, described push rod 22 in described anchor log releasing device 2 is made up of shape-memory alloy wire, the distal portions of described push rod 22 has the shape and angle that are preheated setting, when described anchor log releasing device 2 is released, described push rod 22 can revert to 1/4 circular shape of the circle organizing the least radius r of ring to do for radius with described native valve, as shown in Figure 3 d, make the distal portions 212 of described carrier pipe 21 can along with the distal portions integrally bending being preheated setting of described push rod 22 or bend portions, so that the distalmost end of described carrier pipe 21 is tight against described fixed cell 11 or is tight against autologous tissue 4 before described anchor log 112 is moved.As shown in Figure 3 a, described push rod 22 and described anchor log 112 are all placed in described carrier pipe 21, and described anchor log 112 is positioned at the far-end of described push rod 22.
A kind of operating procedure for the repair system stoping valvular regurgitation with anchoring device is as follows: as shown in Figure 3 a, stoping the prosthese 1, four of valvular regurgitation to overlap anchor log releasing device 2 is held in described outer sheath 32 by radial direction pressure, wherein as shown in Figure 2 d, two cover anchor logs 112 are loaded in the described rigid section 2122 of far-end of the described carrier pipe 21 of adjacent two cover respectively in advance, in extended configuration, described anticreep end 1123 is limited in described carrier pipe 21 because of elasticity.The described push rod 22 of four covers is placed in described four cover carrier pipes 21 respectively in advance, and prosthese 1, the anchor log releasing device 2 of described prevention valvular regurgitation through apex of the heart approach, are admitted to atrium 5 from ventricle 6, as shown in Figure 1a by described induction system 3.As shown in Fig. 3 b-3c, to be dropped back outer sheath 32 by operation induction system 3, discharge prosthese 1 and the anchor log releasing device 2 of described prevention valvular regurgitation, described carrier pipe 21 bends along with described push rod 22, revert to the shape of the scheduled shape of described push rod 22, namely the distal portions of described anchor log releasing device 2 reverts to default shape.As shown in Figure 3 d, in the process, the width due to the expansion of described fixture 111 equals 1/3 of valvular tissue ring girth, so can by rotating described induction system 3, adjust the position of described fixture 111, until arrive the best position of resistance reflux effect.Due to the restriction positioning action of described position line 1124, between the far-end that described fixture 111 is sandwiched in described carrier pipe 21 and described autologous tissue 4, as shown in Fig. 3 d-3f, now, the path that penetrates of described anchor log 112 is defined, and completes positioning action.As shown in figure 3g, promoting described push rod 22 makes described anchor log 112 move to the far-end of described carrier pipe 21, described anchor log 112 is released, described anchor log distalmost end 1121 punctures the dacron membrane at described fixture 111 two ends, through described fixture 111, thrust autologous tissue 4, the distal portions 1122 of described anchor log recovers described by the shape preset.As illustrated in figure 3h, the described outer sheath 32 of recession, helps the far-end of closing member 13 and adjust structure 132 described in release further.As shown in figure 3i, to drop back described carrier pipe 21, discharge the anticreep end 1123 of described anchor log 112, now, the anticreep end 1123 of described anchor log recovers its shape formalized in advance, the prosthese 1 of described prevention valvular regurgitation, between autologous tissue 4 and the anticreep end 1123 of described anchor log, is securely held.The joint 1-3mm place of distance outer sheath 32 and described Tip 31 will be pushed into before described outer sheath 32, to drop back described induction system 3, exit from the apex of the heart, now the near-end of described adjust structure 132 is withdrawn from heart along with described induction system 3, then is drawn out from described induction system 3, finally, as shown in Figure 1 b, image auxiliary under, adjust the degree of tightness of its fixing apex of the heart end, adjust the resistance reflux effect of the prosthese of described tissue valve prosthesis reflux.As shown in figs. lb-1d, described in help closing member 13 to move together with described autologous lobe leaf 7, play resistance reflux effect.
Specific embodiment two:
As depicted in figure 4 a-4 c, a kind of repair system for stoping valvular regurgitation with anchoring device, comprises and stops the prosthese 1, two of valvular regurgitation to overlap anchor log releasing device 2, induction system 3 and two cover bracing or strutting arrangements 8, be used for the treatment of the prolapsus of anterior mitral valve part.
As shown in fig. 4 a, the prosthese 1 of described prevention valvular regurgitation comprises fixed cell 11, connector 12 and helps closing member 13.Described fixed cell 11 comprises fixture and two anchor logs 112, in the present embodiment, described fixture and described anchor log 112 are structure as a whole, described fixture is fixed on autologous patient tissue by described anchor log 112, after described fixed cell 11 launches, the width between two described anchor logs 112 equals 1/4 of valvular tissue ring girth; Described connector 12 is strip, by the coiling of bifilar marmem titanium-nickel wire and pre-heat setting form, the both sides of described connector 12 are the passage 121 that blood passes through, one end of described connector 12 is fixedly connected on described anchor log 112, helps in closing member 13 described in the other end of described connector 12 is fixedly connected at; The described closing member 13 of helping, for single sheet, is made up of polymeric membrane, described in help the near-end of closing member 13 to be provided with expanding unit 131, described expanding unit 131 helps in the outer perimeter of closing member 13 and makes described in development silk is centered around, and helps the expansion of closing member 13 described in being convenient to; As shown in figure 4d, described anchor log 112 is made up of the shaped-memory nitinol silk of diameter 0.3mm, the distalmost end 1121 of described anchor log 112 is tip shape, the distal portions 1122 of described anchor log 112 is preheated and is shaped as arc, the near-end of described anchor log 112 is provided with anticreep end 1123, described anticreep end 1123 is made up of the stainless steel tube being provided with female thread structure, described anticreep end 1123 and described anchor log 112 proximally by being welded to connect.As shown in Fig. 4 b-4c, described anchor log releasing device 2 comprises two cover carrier pipe 21 and two cover push rod 22 (not shown), described induction system 3 is made up of known technology, comprise Tip head (seeker) 31, outer sheath 32 and operating parts 33, 34 (not shown), sheath core 35, the far-end of described sheath core 35 is fixedly connected with described seeker 31, the near-end of described sheath core 35 is fixedly connected with described operating parts, the near-end of described carrier pipe 21 and described push rod 22 is fixedly connected on described operating parts 33 and 34 respectively, described carrier pipe 21 and described push rod 22 can be moved respectively by operating described operating parts 33 and 34.As shown in figure 4d, the distal portions 212 of described carrier pipe 21 strengthens polymer tube by metal spiral and makes, can integrally bending, the proximal part of described carrier pipe 21 is stainless steel tube, described distal portions 212 is socketed on the proximal part of described carrier pipe 21 by hot melt, the distalmost end of described carrier pipe 21 is provided with the rigid section that length equals the half of described anchor log total length, be made up of stainless steel tube, the distalmost end of described carrier pipe equals 1/2 of the girth of the circle done for radius with the least radius r of autologous patient valvular tissue ring to the length of the most proximal end of the bending section 212 of described carrier pipe, described least radius is defined as the cross-wise direction at lobe ring, from lobe ring to the beeline of lobe ring kernel of section.Described push rod 22 is made up of double-layer spiral braided wires, can transmitting torque, liner has marmem titanium-nickel wire, its distal portions 222 is preheated to be shaped as has certain angle, when described anchor log releasing device 2 is released, described push rod 22 can revert to 1/4 circular shape of the circle organizing the maximum radius R of ring to do for radius with described native valve, the distalmost end 223 of described push rod is provided with the steel bushing of the external thread structure matched with the female thread with described anticreep end 1123, described push rod 22 is placed in described carrier pipe 21, the anticreep end 1123 of described anchor log 112 is positioned at the far-end of described push rod 22, be threaded connection with the distalmost end 223 of described push rod 22, removably connecting of described anchor log releasing device 2 and described fixed cell 11 is realized with the removably connecting of push rod 22 of described anchor log releasing device 2 by described anchor log 112, the distal portions 222 of described push rod 22 reverts to default shape, the described bending section 212 of described carrier pipe 21 is bent thereupon.As shown in Figure 4 b, described band anchoring device for stoping the repair system of valvular regurgitation also to comprise two cover bracing or strutting arrangements 8, the near-end of described bracing or strutting arrangement 8 is fixedly connected with the operating parts of described induction system 3, described bracing or strutting arrangement 8 is made up of the marmem titanium-nickel wire of diameter 0.8mm, distal portions has the preheating amorphous form identical with described push rod 22, can bend, after described bracing or strutting arrangement 8 is released, distal portions props up autologous tissue 4, due to the elasticity of autologous tissue 4 self, when the distal portions of described bracing or strutting arrangement 8 is tight against autologous tissue 4, autologous tissue 4 gives described distal portions opposite effect power F, because described bracing or strutting arrangement 8 directly contacts or mediate contact with described carrier pipe 21, such as described bracing or strutting arrangement 8 circumferentially divides equally distribution with described carrier pipe 21, the carrier pipe 21 or passed to by the component of described counteracting force F that described counteracting force F is correspondingly passed to its offside by described bracing or strutting arrangement 8 is in direct contact with it or the carrier pipe 21 of mediate contact, the support force F that described bracing or strutting arrangement 8 provides can ensure to be in direct contact with it or the carrier pipe 21 of mediate contact can continue to prop up described autologous tissue 4, limit acupuncture treatment route, ensure that described anchor log 112 can thrust autologous tissue 4.
Another preferred embodiment in, as shown in Fig. 4 i-4j, described a kind of repair system for stoping valvular regurgitation with anchoring device, comprise the prosthese 1 stoping valvular regurgitation, two cover anchor log releasing devices 2, induction system 3 and two cover bracing or strutting arrangements 8, described two cover bracing or strutting arrangements 8 are adjacent, overlap anchor log releasing device 2 circumferentially divide equally distribution with described two, described induction system 3 comprises seeker 31, outer sheath (not shown), sheath core 35 and operating parts (not shown), described sheath core 35 is arranged in outer sheath, the far-end of described sheath core 35 is fixedly connected with described seeker 31, the near-end of described sheath core 35 is fixedly connected with described operating parts, before releasing, described heart valve prosthesis 1, described anchor log releasing device 2 and described bracing or strutting arrangement 8 are all arranged between described outer sheath and described sheath core 35, described bracing or strutting arrangement 8 is made up of stainless steel tube, the near-end 81 of described bracing or strutting arrangement 8 is fixedly connected with the described operating parts of described induction system 3, the distal portions 82 of described bracing or strutting arrangement 8 is provided with joint-cutting, the distal portions 82 of described bracing or strutting arrangement 8 can be bent, the distal portions 82 of described bracing or strutting arrangement 8 is also connected with the support bar 822 of rigidity, the far-end of described support bar 822 is flexibly connected with described seeker 31.In a preferred embodiment, as shown in figure 4j, with the junction of the distal portions 82 of described bracing or strutting arrangement 8 and described support bar 822 for demarcation line, the part 821 that described distal portions 82 is being positioned at described demarcation line far-end is contrary with the position being positioned at the joint-cutting that the part 823 of described marginal near-end is arranged, to form the bending of serpentine.The distal portions of described push rod 22 is preheated to be shaped as has certain angle, described push rod 22 can revert back to 1/4 circular shape of the circle organizing the maximum radius R of ring to do for radius with described native valve, the distalmost end of described push rod 22 is in pushed process, all the time the part 823 of described marginal near-end is positioned at, after described anchor log releasing device 2 and described bracing or strutting arrangement 8 are released, the described distal portions 82 of described bracing or strutting arrangement 8 is at the flex under action of described seeker 31 and described support bar 822, first be that the shape that the part 823 being positioned at described marginal near-end is preset along with described push rod bends, after the part 821 being positioned at described marginal far-end contacts with autologous tissue, owing to being provided with joint-cutting, the part 821 being positioned at described marginal far-end bends gradually, then tightly autologous tissue is propped up.Due to the elasticity of autologous tissue self, when the described distal portions 82 of described bracing or strutting arrangement 8 is tight against autologous tissue, autologous tissue gives described distal portions 82 opposite effect power F, due to described bracing or strutting arrangement 8 and the mediate contact of described carrier pipe 21, such as described bracing or strutting arrangement 8 circumferentially divides equally distribution with described carrier pipe 21, described counteracting force F is correspondingly passed to the carrier pipe of its offside by described bracing or strutting arrangement 8, the support force that described bracing or strutting arrangement 8 provides can ensure can continue to prop up described autologous tissue with the carrier pipe 21 of its mediate contact, limit acupuncture treatment route, ensure that described anchor log 112 can thrust autologous tissue.In a preferred embodiment, the distal portions of described carrier pipe 21 is also connected with the support bar 822 of rigidity, the far-end of described support bar 822 is flexibly connected with described seeker 31, to control the angle of bend of the distal portions of described carrier pipe 21 better.In a further advantageous embodiment, as shown in fig. 4k, described bracing or strutting arrangement 8 quantity is a set of, and when described carrier pipe 21 quantity is a set of, described bracing or strutting arrangement 8 is symmetric with described carrier pipe 21.Or in a further advantageous embodiment, as shown in Fig. 4 l, the near-end of described bracing or strutting arrangement 8 is fixedly connected with the described operating parts of described induction system and the far-end of described bracing or strutting arrangement 8 is flexibly connected with the described seeker 31 of described induction system, the distal portions of described carrier pipe 21 is connected with the support bar 822 of rigidity, and the far-end of described support bar 822 is flexibly connected with described seeker 31.Or in a further advantageous embodiment, as shown in Fig. 4 m, the near-end of described bracing or strutting arrangement 8 is fixedly connected with the described operating parts of described induction system, the distal portions of described bracing or strutting arrangement 8 can bend, and its distalmost end is dissociated, the distal portions of described carrier pipe 21 is connected with the support bar 822 of rigidity, and the far-end of described support bar 822 is flexibly connected with described seeker 31.In another preferred embodiment, the quantity of described anchor log 112 and described anchor log releasing device 2 is not one to one, the tricks of described anchor log releasing device 2 is greater than the quantity of described anchor log 112, and the anchor log releasing device 2 not placing described anchor log 112 can use as described bracing or strutting arrangement 8.
A kind of operating procedure for the repair system stoping valvular regurgitation with anchoring device is as follows: as illustrated in fig. 4 c, the prosthese 1, two of valvular regurgitation cover anchor log releasing device 2 and two cover bracing or strutting arrangements 8 are stoped to be held in described outer sheath 32 by radial direction pressure, wherein said two cover anchor logs 112 are loaded in the distal portions of the adjacent described carrier pipe 21 of two covers respectively in advance, the distal portions 1122 of described anchor log 112 is positioned at the described rigid section of described carrier pipe 21, in extended configuration, described anticreep end 1123 is threaded with the distalmost end 223 of described push rod.The described push rod 22 of two covers is placed in the described carrier pipe 21 of two covers respectively in advance, the prosthese 1 of described prevention valvular regurgitation, anchor log releasing device 2 by described induction system 3 through apex of the heart approach, to be dropped back outer sheath 32 by operation induction system 3, discharge the prosthese 1 of described prevention valvular regurgitation, anchor log releasing device 2 and bracing or strutting arrangement 8, as shown in figure 4d, described carrier pipe 21 bends along with described push rod 22, revert to the shape of the scheduled shape of described push rod 22, the distal portions of described bracing or strutting arrangement 8 reverts to the shape identical with the scheduled shape of described push rod 22, same, in the process, after described fixed cell 11 expansion, width between described anchor log 112 equals 1/4 of valvular tissue ring girth, so can by rotating described induction system 3, adjust the position of described anchor log 112 (i.e. fixture), until arrive the best position of resistance reflux effect.As shown in Fig. 4 e-4f, promoting described push rod 22 makes described anchor log 112 move to the far-end of described carrier pipe 21, described anchor log 112 is released, the distalmost end 1121 of described anchor log 112 thrusts autologous tissue 4, and the distal portions 1122 of described anchor log 112 recovers the arcuate shape of described scheduled shape.As shown in figure 4g, operate the operating parts of described induction system 3, described push rod 22 is reversed, thus the removably connecting of distalmost end 223 of described anticreep end 1123 and described push rod 22 is removed, discharge described anticreep end 1123.As shown in figure 4h, operate the operating parts of described induction system 3, described carrier pipe 21 is dropped back, and the prosthese 1 of described prevention valvular regurgitation is fixed on autologous patient tissue 4 by described anchor log 112, the described closing member 13 that helps is moved together with described autologous lobe leaf 7, plays the effect of resistance reflux.
Specific embodiment three:
As shown in Fig. 5 a-5g, the prosthese 1 of described prevention valvular regurgitation comprises fixed cell 11, connector 12 and help closing member 13, described fixed cell 11 comprises fixture 111 and anchor log 112, be different from complete loop structures product in prior art, can along the circumference adjustment position of patient's lobe ring after described fixed cell 11 launches, as combined lobe position (Fig. 5 a), front lobe leaf position (Fig. 5 b) or posterior valve leaflet position (Fig. 5 c), until operator according to described help closing member 13 and self lobe leaf 7 situation of fitting to judge the position of most suitable resistance reflux after, carry out grappling location again, discharge described anchor log 112, realize fixing between described prosthese 1 and autologous tissue 4, really achieve while accurately treating pathological changes, remain the valvular normal physiological function of residue, decrease the valvular interference to normal operation, realize position adjustable, accurate positioning, secure anchorage and pathological changes adaptability, and can prevent because compressing associating lobe causes new perivalvular leakage.When there is the prolapse of valve cusp of many places diverse location in patient, traditional complete loop product is owing to limitting in space, the closing member that helps according to larger area then can oppress self normal lobe leaf closedown, then good efficacy cannot be obtained according to the closing member that helps compared with small size, and complete loop structures product can oppress adjacent organs, as aortic valve, affect its normal function.And the width that fixture 111 of the present invention launches is less, allow doctor to implant many pieces of apparatuses at different lesions position, as fig 5d, strengthen the effect stoping valvular regurgitation.When the prosthese 1 of described prevention valvular regurgitation is applied to treatment tricuspid incompetence, same, after described fixed cell 11 launches, position can be adjusted, as shown in Fig. 5 e-5g along patient's lobe ring circumference.
Specific embodiment four:
As shown in Fig. 6 a-6g, being a kind of repair system for stoping valvular regurgitation with anchoring device of the present invention, comprising the prosthese 1, anchor log releasing device 2 and the induction system 3 that stop valvular regurgitation, from apex of the heart approach, being used for the treatment of mitral incompetence.
As shown in Figure 6 a, be with the difference of specific embodiment two, described prosthese fixture 111 is separated in the process being transported to diseased region with described anchor log 112, and removably connecting of described anchor log releasing device 2 and described fixed cell 11 is realized with described removably connecting of anchor log releasing device 2 by described fixture 111.As shown in Figure 6 a, described anchor log 112 is made up of the shaped-memory nitinol silk of diameter 0.4mm, the distalmost end 1121 of described anchor log 112 is tip shape, the distal portions 1122 of described anchor log 112 is preheated and is shaped as arc, the near-end of described anchor log 112 is equipped with anticreep end 1123, described anticreep end 1123 is made up of the stainless steel tube being provided with female thread structure, and described anticreep end 1123 is connected with the near-end of described anchor log 112 is soldered.As shown in Fig. 6 a-6b, described carrier pipe 21 is made up of stainless steel tube, comprise two-layer pipe 211 and 212, wherein inner tube 211 is placed in outer tube 212, the distal portions of described outer tube 212 is fixedly connected with connecting line 23, prevent wraparound after the prosthese 1 of valvular regurgitation described in the other end of described connecting line 23 passes, be sandwiched between described inner tube 211 and the distal portions of outer tube 212, described connecting line 23 is made up of the marmem titanium-nickel wire of diameter 0.1mm.The far-end of described inner tube 211 and outer tube 212 is by reducing reducing, the shape preset that the distal portions of described inner tube 211 and outer tube 212 can have due to the distal portions of described anchor log releasing device 2 and realize integrally bending, the part that described inner tube 211 and outer tube 212 can bend is bending section, described bending section has joint-cutting, the seemless section of rigidity is provided with in the distalmost end of described carrier pipe 21, the length of described rigid section is greater than 1/3rd of described anchor log 112 total length, the near-end of described carrier pipe 21 is fixedly connected with carrier pipe operating parts (not shown), described inner tube 211 and outer tube 212 are fixedly connected on described carrier pipe operating parts respectively, or the near-end of described carrier pipe 21 is fixedly connected on the described operating parts of described induction system 3.The distalmost end of described carrier pipe 21 equals 1/3 of the girth of the circle done for radius with the maximum radius R of autologous patient valvular tissue ring to the length of the most proximal end of the bending section 212 of described carrier pipe 21, described maximum radius is defined as the cross-wise direction at lobe ring, from lobe ring to the longest distance of lobe ring kernel of section.As shown in Figure 6 b, the distal portions of described outer tube 212 has hole, be used for fixing described connecting line 23.As shown in Figure 6 a, described anchor log 112 and described push rod 22 prepositioned in the described inner tube 211 of described carrier pipe 21, the described anticreep end 1123 of described anchor log 121 is positioned at described push rod 22 far-end.As shown in figure 6g, the far-end of described push rod 22 is provided with has externally threaded ferrule 223, removably connect with the anticreep end 1123 of described anchor log 112, described push rod 22 is made up of double-layer spiral braided wires, can transmitting torque, liner has marmem titanium-nickel wire, and distal portions is preheated to be shaped as to be had certain angle and have default shape to the distal portions realizing described anchor log releasing device 2.When described anchor log releasing device is released, described push rod 22 can revert to 1/4 circular shape of the circle organizing the maximum radius R of ring to do for radius with described native valve.
As fig. 6 c, promote described push rod 22, make described anchor log 112 be pushed out the far-end of described inner tube 211, now the distalmost end 1121 of described anchor log 112 is through described prosthese fixture 111, thrust autologous tissue 4, the distal portions of described anchor log 112 recovers its shape preset.As shown in fig 6d, by controlling described carrier pipe operating parts (not shown), described inner tube 211 of dropping back, what discharge the prosthese 1 of described carrier pipe 21 and described prevention valvular regurgitation removably connects 23.As shown in fig 6e, by controlling described carrier pipe operating parts (not shown), described outer tube 212 of dropping back, makes one end of described connecting line 23 be pulled out until be separated with described fixture 111.As shown in Fig. 6 f-6g, by operating the operating parts of described induction system 4, described push rod 22 is reversed, thus the removably connecting of ferrule 223 of described anticreep end 1123 and described push rod far-end is removed, discharge described anticreep end 1123, the prosthese 1 of described prevention valvular regurgitation is firmly held on mitral lobe ring, continues to recall described releasing device 2 and induction system 3, complete implantation process.
Specific embodiment five:
Preferably, described anchor log 112 can have multiple default shape, and as Fig. 7 a, the scheduled shape of distal portions of described anchor log 112 is the combination shape of camber line and straight line, also with an agnail, increases the anchoring effect of described anchor log 112; As shown in Figure 7b, the shape of the distalmost end 1121 of described anchor log is designed to anticreep step; As shown in Figure 7 c, the scheduled shape of distal portions 1122 of described anchor log 112 is arc, and also with two agnails, described anticreep end 1123 is extended further by the distal portions 1122 of described anchor log 112; As shown in figure 7d, the distalmost end 1121 of described anchor log 112 is tip shape, the scheduled shape of distal portions 1122 of described anchor log 112 is spiral type, described anticreep end 1123 is the inner stainless steel tube containing rustless steel screw thread, in a further preferred embodiment, described anchor log 112 can be made up of elastic alloy, and being previously cut to distal portions is arc (not shown).
Specific embodiment six:
Fig. 8 a-Fig. 8 e shows the numerous embodiments of the prosthese 1 of described prevention valvular regurgitation.As shown in Figure 8 a, the prosthese 1 of described prevention valvular regurgitation, comprise fixed cell 11, connector 12 and help closing member 13, described fixed cell 11 comprises fixture 11l and at least two anchor log 112, described fixture 111 has framing structure and by part overlay film, described fixture 111 is fixed in patient's atrial walls or on lobe ring by described anchor log 112.The distal portions of described connector 12 is connected with the proximal part of described fixture 111, the proximal part of described connector 12 is connected with the described distal portions of closing member 13 that helps, described connector 12 is flexible, the remote extension of described connector 12 goes out many wire-wounds and is connected on the proximal part of described fixture 111, describedly help the remote extension of closing member 13 to go out many wire-wounds to be connected on the proximal part of described connector 12, preferably, described line extends to described fixture 111 from the described closing member 13 that helps always.Help described the passage 121 that there is between closing member 13 and described fixture 111 blood supply liquid stream and cross, preferably, described in help closing member 13 for column, its cross section be ellipse, helps closing member 13 can to fit substantially patient self lobe leaf described in making.As shown in Figure 8 b, described fixture 111 is high molecular sheet, described anchor log 112 is connected with described fixture 111 by line 1124, described connector 12 is strip, formed by multiply macromolecule wire-wound system, the both sides of described connector 12 are the passage that blood flows through, described in help closing member 13 for single sheet, described fixture 111 is connected with the described closing member 13 that helps by described connector 12.As shown in Figure 8 c, described anchor log 112 is structure as a whole with described fixture 111, described connector 12 is two rhizoids, the far-end of described connector 12 is connected on described anchor log 112, help in closing member 13 described in the near-end of described connector 12 is connected to, described in help closing member 13 to be the combination of monolithic and tubular.As shown in figure 8d, by part overlay film on described fixture 111, be convenient to the fixing of described anchor log 112, described helping in closing member 13 is provided with adjust structure 132, described adjust structure 132 is tinsel or macromolecule line, help in closing member 13 described in one end of described tinsel or macromolecule line is connected to, the other end of described tinsel or macromolecule line is connected on ventricle or the apex of the heart, the benefit of such design is that doctor can adjust described tinsel or macromolecule line in art, again the other end of described tinsel or macromolecule line is fixed on ventricle or the apex of the heart when making valvular regurgitation reach minima, expanding unit 131 is also provided with at the described near-end of closing member 13 that helps, described expanding unit 131 is by the wavy shaped configuration of metal memory material filament winding system or zigzag structure, closing member 13 is helped to launch described in being convenient to.As figure 8 e shows, described fixture 111 has framing structure, described framing structure is latticed support, described framing structure film, described anchor log 112 is connected with described film, described in help closing member 13 to be the combination of monolithic and sacculus, described balloon surface is for dredging Porous materials, the inside is containing water uptake expansion material, and it can be fitted with patient's lobe leaf after expanding in blood, is used for the treatment of the patient that reflux area is larger.
Finally should be noted that; the foregoing is only preferred embodiment of the present invention; not in order to limit the present invention, all any amendments done within the spirit and principles in the present invention, equivalent replacement and improvement etc., all should be included within protection scope of the present invention.
Claims (15)
1. the repair system for stoping valvular regurgitation with anchoring device, it is characterized in that, comprise the prosthese and anchor log releasing device that stop valvular regurgitation, the prosthese of described prevention valvular regurgitation comprises fixed cell, connector and help closing member, described fixed cell comprises fixture and anchor log, the distal portions of described connector is connected with the proximal part of described fixture, the proximal part of described connector is connected with the described distal portions of closing member that helps, described connector is flexible, make described connector and help closing member can move along with the motion of lobe leaf described in being attached thereto, described fixture is fixed in patient's atrial walls or on lobe ring by described anchor log, describedly help closing member when free state between autologous patient lobe leaf, the distal portions of described anchor log has default shape, the near-end of described anchor log is provided with anticreep end, described anchor log releasing device comprises carrier pipe and push rod, described anchor log releasing device and described fixed cell removably connect, the distal portions of described anchor log releasing device has default shape, make the distal portions of described carrier pipe can integrally bending or bend portions, so that the distalmost end of described carrier pipe is tight against described fixed cell or is tight against autologous tissue before described anchor log is moved, the distalmost end of described carrier pipe is provided with rigid section, described anchor log is pre-filled with in the distal portions of described carrier pipe with extended configuration, described push rod is placed in described carrier pipe, described anchor log is positioned at the far-end of described push rod, promoting described push rod can make described anchor log move to the far-end of described carrier pipe, after described anchor log is pushed out described carrier pipe, the distal portions of described anchor log can recover its shape preset, the prosthese of described prevention valvular regurgitation is fixed between described autologous tissue and the described anticreep end of described anchor log by described anchor log.
2. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, it is characterized in that, the part that described carrier pipe can bend is bending section, the distalmost end of described carrier pipe to the described bending section of described carrier pipe most proximal end between length be more than or equal to 1/6th of the girth of the circle done with the least radius of autologous patient valvular tissue ring.
3. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, is characterized in that, the width that described fixture launches is less than 2/3rds of valvular tissue ring girth.
4. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, is characterized in that, the described Breadth Maximum of closing member that helps is less than the Breadth Maximum of single described autologous lobe leaf expansion.
5. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, it is characterized in that, the described closing member that helps is monolithic, multi-disc, tubular, bag-shaped, column or sacculus, or described in help closing member to be the combination of monolithic and multi-disc, or described in help closing member to be the combination of monolithic and tubular, or described in help closing member to be monolithic and bag-shaped combination, or described in help closing member to be the combination of monolithic and column, or described in help closing member to be the combination of monolithic and sacculus.
6. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, is characterized in that, described in help the near-end of closing member to be provided with expanding unit, described expanding unit is made up of tinsel or macromolecule line.
7. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, it is characterized in that, described helping in closing member is connected with adjust structure, described adjust structure is tinsel or macromolecule line, help in closing member described in one end of described tinsel or described macromolecule line is connected to, the other end of described tinsel or described macromolecule line is connected on ventricle or the apex of the heart, by the distance between the two ends that adjust described tinsel or described macromolecule line, described in adjusting, help the effect of the resistance reflux of closing member.
8. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, it is characterized in that, described anchor log is connected with described fixture, and removably connecting of described anchor log releasing device and described fixed cell is realized by described anchor log and described removably connecting of anchor log releasing device.
9. the repair system for stoping valvular regurgitation of band anchoring device according to claim 8, is characterized in that, described anchor log and described fixture are structure as a whole.
10. the repair system for stoping valvular regurgitation of band anchoring device according to claim 1, is characterized in that, helps described the passage having blood supply liquid stream between closing member and described fixture and cross.
The repair system for stoping valvular regurgitation of 11. band anchoring devices according to claim 1, is characterized in that, the length of the described rigid section of described carrier pipe is more than or equal to 1/10th of the total length of described anchor log.
The repair system for stoping valvular regurgitation of 12. band anchoring devices according to claim 1, it is characterized in that, the scheduled shape of distal portions of described carrier pipe, make the distal portions of described push rod can along with the distal portion bends of the scheduled shape of described carrier pipe, or the scheduled shape of the distal portions of described push rod, the described distal portions of described carrier pipe is bending with the shape of the scheduled shape of described push rod, or all scheduled shape of the distal portions of described carrier pipe and described push rod, the distal portions of described carrier pipe is bent together with the distal portions of described push rod.
The repair system for stoping valvular regurgitation of 13. band anchoring devices according to claim 1, is characterized in that, the described anticreep end of described push rod and described anchor log removably connects.
The repair system for stoping valvular regurgitation of 14. band anchoring devices according to claim 1, it is characterized in that, described band anchoring device for stoping the repair system of valvular regurgitation also to comprise bracing or strutting arrangement and bracing or strutting arrangement operating parts, described bracing or strutting arrangement operating parts is fixedly connected with the near-end of described bracing or strutting arrangement, the distal portions of described bracing or strutting arrangement can bend, after described bracing or strutting arrangement is released, the described distal portions of described bracing or strutting arrangement props up autologous tissue.
The repair system for stoping valvular regurgitation of 15. band anchoring devices according to claim 1, it is characterized in that, described band anchoring device for stoping the repair system of valvular regurgitation also to comprise bracing or strutting arrangement and induction system, described induction system comprises seeker, outer sheath, sheath core and operating parts, described sheath core is arranged in outer sheath, the far-end of described sheath core is fixedly connected with described seeker, the near-end of described sheath core is fixedly connected with described operating parts, the prosthese of described prevention valvular regurgitation, described anchor log releasing device and described bracing or strutting arrangement are all arranged between described outer sheath and described sheath core, the near-end of described bracing or strutting arrangement is fixedly connected with the described operating parts of described induction system, or the far-end of described bracing or strutting arrangement is fixedly connected with the described seeker of described induction system, or the near-end of described bracing or strutting arrangement is fixedly connected with the described operating parts of described induction system and the far-end of described bracing or strutting arrangement is fixedly connected with the described seeker of described induction system, when described anchor log releasing device is released, described bracing or strutting arrangement gives described anchor log releasing device support force.
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| CN104055605B (en) | 2014-07-07 | 2016-06-01 | 宁波健世生物科技有限公司 | A kind of for stoping the prosthese of valve reflux |
| CN104055604B (en) * | 2014-07-07 | 2016-06-01 | 宁波健世生物科技有限公司 | The heart valve implantation instrument of a kind of band anchoring device |
| GB2536538B (en) | 2014-09-17 | 2018-07-18 | Cardiomech As | Anchor for implantation in body tissue |
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| JP7111610B2 (en) | 2015-08-21 | 2022-08-02 | トゥエルヴ， インコーポレイテッド | Implantable Heart Valve Devices, Mitral Valve Repair Devices, and Related Systems and Methods |
| JP6659845B2 (en) * | 2015-12-18 | 2020-03-04 | ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． | Cardiac tissue anchor |
| CN106264793B (en) * | 2016-10-24 | 2021-04-27 | 宁波健世生物科技有限公司 | Self-adaptive heart valve prosthesis |
| US11419719B2 (en) | 2017-02-06 | 2022-08-23 | Mtex Cardio Ag | Methods and systems for assisting or repairing prosthetic cardiac valves |
| EP3576676A2 (en) * | 2017-02-06 | 2019-12-11 | MTEx Cardio AG | Methods and systems for assisting or repairing prosthetic cardiac valves |
| CN107260365B (en) * | 2017-06-22 | 2024-01-09 | 上海形状记忆合金材料有限公司 | Interventional system for repairing mitral valve |
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| CN108904100B (en) * | 2018-06-22 | 2021-01-19 | 宁波健世生物科技有限公司 | Implanting instrument for preventing valve regurgitation and conveying system thereof |
| CN110179566B (en) * | 2019-04-11 | 2023-07-28 | 宁波健世科技股份有限公司 | Prosthesis conveying system with positioning function |
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