Background technology
Heart is the most important organ of human body, and heart is divided into left and right sides two parts, and each part comprises atrium and ventricle again.Left atrium and left and right ventricles are separated by interatrial septum and interventricular septum respectively.In heart, there are four cardiac valve, i.e. Tricuspid valve, valve of pulmonary trunk, Bicuspid valve and aortic valve.In the blood of human body cycling mechanism, four cardiac valve play crucial effects.The anoxia blood of body cycling mechanism enters right atrium through caval vein, enter right ventricle by Tricuspid valve then, right ventricle shrinks blood is pressed into pulmonary circulation mechanism by valve of pulmonary trunk, get back to left atrium through the blood behind the lung oxygen saturation through pulmonary vein, arrive left ventricle through Bicuspid valve again, the left ventricle contraction enters aorta with blood by aortic valve and returns to the body cycling mechanism.Left and right sides coronary ostium is arranged under the aortic valve.Close when valve-open when four valvular structures have guaranteed blood along direction, contrary direction, prevented blood reflux and the heart burden that causes.But, because a variety of causes can cause valvular posteriority damage or pathological changes, as rheumatism, atherosclerosis etc.In addition, congenital heart disease such as fallot's disease, postoperative also can produce the cusps of pulmonary valve pathological changes long term.Show as valvular function after the valve pathological changes and lose gradually, cause blood reflux as valvular insufficiency, valvular stenosis causes blood circulation not smooth, or incompetence and narrow the two merger, so that increase the weight of the heart burden, causes cardiac failure.For valvular posteriority damage or pathological changes, traditional Therapeutic Method is out breast, after the cardiac arrest, under the cryotron outer circulation is supported, opens heart and carries out the surgical repair of pathological changes valve or use artificial cardiac valve replacement.Existing Cardiac valve prosthesis divides two big classes: metal mechanical valve prosthesis and biovalve.Biovalve is made after being handled by animal materials such as bovine pericardium, bovine jugular vein lobe, porcine aortic valve.The method of above-mentioned open heart operation, operating time is long, the expense height, wound is big, has a big risk, and metal mechanical valve prosthesis displacement back patient needs long-term anticoagulant therapy, and the material lifetime of biovalve is limited, needs operation more usually.
In order to solve the problem that above-mentioned open heart operation treatment cardiac valve exists, existing now people attempts not doing open heart operation, and adopts the defeated Cardiac valve prosthesis of putting of percutaneous interventional method.The insertion type Cardiac valve prosthesis of prior art has two kinds:
1, balloon-expandable
This balloon-expandable Cardiac valve prosthesis is a biovalve, its interventional method is a difference fixed biologically valve on the support of a plastically deformable, diminishes by radial compression back diameter on a sacculus, and percutaneous is defeated to be put, pressurization makes the support expansion fixing to sacculus then, reaches duty.
1989 Henning Rud ANDERSEN (patent No. WO9117720) take the lead in having carried out porcine aortic valve through conduit cardiac-valve prosthesis displacement (document ... European Heart Journal 1,992 13,704-708).
Philippe BONHOEFFER (patent No. EP1057460) in 2000 and Alain CRIBIER (patent No. EP0967939) have carried out respectively first in the cusps of pulmonary valve of getting involved through conduit of human body and the Cardiac valve prosthesis displacement of aortic valve.
Shortcoming and problem that balloon-expandable artificial valve exists are: its diameter is determined by balloon diameter, if artificial valve's diameter does not choose at the beginning, or after some physiological change, as self-sow, pathologic vessels expansion etc., the caliber size of nature valve may increase, and artificial valve's bore can not increase by adaptability, and the artificial valve has the danger of loosening or slippage, can only carry out the further expansion of secondary sacculus.
2, self expandable type
This artificial valve is provided with a strain support, can expand voluntarily after the radial compression.
(patent No. FR2826863 FR2828091) has also designed through conduit cardiac-valve prosthesis and has replaced for Marc BESSLER (patent No. US5855601) and Jacques SEGUIN.Different is that they have used an elastically deformable support, can expand voluntarily after the radial compression.
(patent No. EP1281375, Cardiac valve prosthesis US2003036791) utilize an elastically deformable support to Philippe BONHOEFFER, at support upstream extremity or far-end contact are housed, and are pressed in inside and outside two sheath pipes.
The applicant once mentioned in Chinese invention patent application number 200410054347.0 and has used the stage casing to strengthen being combined to stent valve as the stent valve and the self-extending type of drum type, and the cluster apparatus for delivering.
Shortcoming and problem that self expandable type artificial valve exists are: frictional force is big between self expandable type Cardiac valve prosthesis and sheath pipe, influences the artificial valve and accurately discharges.
The support backguy of this cluster apparatus for delivering, frictional force is big when passing artificial valve's deformable unit, and backguy is easily dislocated when not passing.
Common drawback and problem that above-mentioned balloon-expandable and self expandable type Cardiac valve prosthesis exist are:
1, the apparatus for delivering of existing insertion type man-made support valve and the stent valve under the radial compression are harder, and bendability is poor, are not easy through aortic arch, can not aim at nature aortic valve mouth.
Even if 2 under the help of x x ray fluoroscopy x, the axial upstream and downstream location of insertion type man-made support valve and its apparatus for delivering also is not easy because of unstable the becoming of artificial valve under and the blood flow impact inaccurate to the judgement of anatomical position.The resistance coronary ostium if swimming on the upper side, insertion type prosthetic aortic valve position can influence Bicuspid valve, if downstream can be blocked up in the position.
3, the direction of rotation of insertion type aortic valve man-made support valve and its apparatus for delivering location fails to solve.If insertion type prosthetic aortic valve position of rotation is not to blocking up the resistance coronary ostium.
4, under the self-extending type man-made support valve high compression, the rollback of sheath pipe can run into very big resistance.Move back the resistance of sheath pipe and the man-made support valve displacement that difficulty also can make the operator locate.
5, in dispose procedure, stent valve partly is expanded to full expansion gradually, and required time surpasses a heart beat cycle.The stent valve of expansion can hinder blood flow, and stent valve also can make its position change because of blood flow impacts.Balloon-expandable man-made support valve complete blocking blood flow in the balloon expandable process particularly.
If 6 patients have coronary bypass (Coronary Artery Bypass), the man-made support valve of having implanted should not be in the hemoperfusion that the ascending aorta place influences the bridging opening.
7, the aortic valve self-expanding stent valve of Jacques SEGUIN and Philippe BONHOEFFER if can successfully be implanted, though postoperative can not influence perfusion coronarius at once, but mid-stent is not pasted blood vessel wall at aortic root, allow blood flow from the support mesh, flow through, have thrombotic possibility on the one hand; Can influence or hinder following possible coronary artery intervention diagnosis and treatment on the other hand.
8, also there is following problem in the fixing of stent valve that discharges after expanding:
A) systole and the impact of relaxing period blood flow can make fixing bad man-made support valve move.
B) existing pathologic expansion before its aortic root art of the patient of some aortic incompetence needs very big stent valve to coincide fixing with it.
C) some patient implants the part, back at the man-made support valve and has anatomical and change, as expansion, make can not respective change stent valve lose effectively fixing.
9, the man-made support valve after expansion is fixed has perivalvular leakage (Para valvularleaks) under many circumstances, and promptly blood leaked between stent valve and blood vessel wall.
Can to bear very big stress if 11 adopt major diameter stent valve, lobe leaf to unite point (Commi ssure) in order fixing, to cause valve leaflet to unite and a little tear damage.
Summary of the invention
Purpose of the present invention is to overcome the problems referred to above that prior art exists, and a kind of apparatus for delivering of artificial heart stent valve of new structure is provided, and both can be used for the insertion type treatment, also can be used for the Minimally Invasive Surgery treatment.
The object of the present invention is achieved like this: a kind of apparatus for delivering of artificial heart stent valve, be characterized in, and comprise conductor housing, interior pipe, near-end controller, middle pipe, wire leading pipe, outer protection mechanism, at least one locking silk and at least one support backguy; Described conductor housing, interior pipe and near-end controller fuse in proper order and are interconnected; the pipe box dress can slide along interior pipe on inner pipe in described; described wire leading pipe is arranged in the conductor housing that fuses, interior pipe and the near-end controller; the far-end of described outer protection mechanism big envelope pipe outside interior pipe and middle pipe and in being movable to, described locking silk and support backguy are located in respectively in the interior pipe and near-end controller that fuses.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, described conductor housing is streamlined hollow cone body structure, its big end is that the rear end is connected with interior pipe far-end, its small end is that front end is provided with thread eye and is communicated with wire leading pipe, and the leading portion of conductor housing is provided with at least one side opening and communicates with interior pipe, and conductor housing is made of softish macromolecular material, wherein contain the opacity material, or be embedded with radiopaque marker.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, Guan Weiyi elongate tubular structure in described, comprise be used for the interior pipe that links to each other with artificial heart stent valve section far away, bow arcual near section of pipe stage casing and the interior pipe that is communicated with the near-end controller, be provided with the vestibule that at least one allows various silks, line pass through in the interior pipe, interior pipe section far away is provided with at least one side opening.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described in pipe for pipe in the single hole, only be provided with a big circular general vestibule in the interior pipe, described wire leading pipe is arranged in this vestibule and can slides along interior pipe.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, pipe is pipe in the single hole in described, only be provided with a big circular general vestibule in the interior pipe, described wire leading pipe is set in this vestibule, also be provided with a backguy pipe and a locking fiber tube, can slide mutually between described wire leading pipe, backguy pipe and the locking fiber tube.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in that described interior pipe is provided with a small circular wire leading pipe for pipe in the diplopore near interior tube edges, remainder forms the general pipe of big semilune, and adhesion is fixing between described small circular wire leading pipe and the big general pipe of semilune can not slide.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, pipe in the Guan Weisan hole in described, be provided with a small circular wire leading pipe near interior tube edges, remainder is divided into two halves, form the identical general pipes of two shapes symmetry, adhesion is fixing between the identical general pipe of described small circular wire leading pipe and two shape symmetries can not slide.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, pipe in the Guan Weisi hole in described, be provided with a small circular wire leading pipe near interior tube edges, the interior tube edges on wire leading pipe opposite is provided with small circular locking fiber tube, remainder is divided into two halves, forms two identical general pipes of shape symmetry, and adhesion is fixing between each pipe can not slide.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, the side opening of pipe section far away is three in described being located at, and comprises distal openings, middle side opening and proximal open, and three side openings are all at the same plane and the same side of interior pipe.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, the periphery of described side opening is provided with reinforcing ring, this reinforcing ring is made of the good metal material of intensity height, frictional property or intensity height, macromolecular material that frictional property is good, when reinforcing ring is made of metal material, be used as radiopaque marker.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, the middle level of described interior pipe accompanies the braiding reinforcing mat, and interior pipe side opening is opened in a grid of braiding reinforcing mat.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described interior pipe is spiral bourdon tube, and the spring wire of bourdon tube section far away forms distal openings, middle side opening and the proximal open of interior pipe at the part formation semi-ring or the domain.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described spiral bourdon tube is surrounded by the macromolecular material pipe outward, and the macromolecular material pipe is provided with opening at semi-ring or domain place corresponding to bourdon tube.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, described near-end controller is a dendritic structure, comprise a main pipe and at least one backguy arm of being communicated with main pipe, at least one locking arm, one wash and radiography arm and at least one seal wire arm.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, the oblique side that is connected near-end controller main pipe of described backguy arm, and be positioned at same side with the side opening of interior pipe, be provided with resistant to blood refluence film in the backguy arm, be provided with the pin hole that allows backguy pass through in the middle of the film, being provided with the backguy fastener in the backguy arm can be fixed on a certain ad-hoc location of backguy on the backguy arm.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, described backguy arm is three, three oblique respectively the same sides that are connected near-end controller main pipe of backguy arm, and correspond respectively to far-end backguy, stage casing backguy and near-end backguy in proper order by front and back, form far-end backguy arm, stage casing backguy arm and near-end backguy arm.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, the oblique side that is movably connected in near-end controller main pipe of described locking silk arm, on main pipe and connector locking silk arm, be provided with the resistant to blood film that backflows, be provided with the pin hole that allows lock-in line pass through in the middle of the film, be provided with a sliding bar in the locking silk arm, the front end of sliding bar links to each other with the locking silk, the rear end protruded tube of sliding bar forms operating grip outward, the middle part of sliding bar has a groove, position corresponding to this groove on the locking silk arm is provided with far-end dowel hole and proximally-located pin-and-hole, two alignment pins can pass two dowel holes on the locking silk arm respectively and will locks a silk arm with groove on the sliding bar and link to each other with sliding bar, by fixing or the releasing alignment pin can determine whether the locking silk of sliding bar and connection thereof slides and control its sliding distance.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described locking silk arm is two, two oblique respectively the same sides that are connected near-end controller main pipe of locking silk arm, and correspond respectively to two locking silks.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, the near-end of pipe is near the near-end controller in described, far-end is less than the proximal open of interior pipe, near section at middle pipe is connected with a side pipe, be provided with in one in the middle pipe and manage backguy, the remote port of pipe during the far-end of middle pipe backguy is fixed on, in the near-end of pipe backguy therefrom manage near section side pipe and draw, in the side pipe of the pipe far-end fixing point of backguy and the nearly section of middle pipe be arranged on same plane and with on one side, respectively be equipped with a shrink-ring at the port of middle pipe near-end and the port of side pipe, can slide along interior pipe when this shrink-ring loosens, fixing certain position on inner pipe during deflation.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, manages slightly certain taper in described, and section far away is thinner, and nearly section is thicker, make apparatus for delivering obtain simultaneously nearly section promotion and in section bendability far away.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, the far-end of described wire leading pipe is communicated with conductor housing, and near-end is communicated with seal wire arm on the near-end controller, and the part of wire leading pipe in interior pipe stage casing is positioned at the protruding side in pipe stage casing.
A kind of apparatus for delivering of artificial heart stent valve; be characterized in; described outer protection mechanism is a tubulose epitheca pipe; the far-end tube wall of this epitheca pipe is embedded with radiopaque marker, and nearly section is provided with flushing/radiography opening and valve, is provided with elastica in the proximal port; elastica central authorities are provided with aperture; little bore closure or have only very little diameter under the normal condition, the diameter of aperture can enlarge when middle pipe passed, and slided and elastica is not leaked blood with pipe in guaranteeing.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described outer protection mechanism is peelable outer protection mechanism, comprises peelable sheath pipe and is used for the provisional take-up lock silk that tightens up the sheath pipe take-up of peelable sheath pipe and be used to lock the take-up of sheath pipe; Far away section of peelable sheath pipe is provided with a longitudinal opening and runs through far-end, longitudinal opening both sides sheath pipe is provided with a plurality of take-up eyes, and the distal diameter of peelable sheath pipe is dwindled, and it is streamlined to constitute bullet, nearly section part is a complete pipe in the peelable sheath pipe, and its diameter is less than or equal to far away section diameter; The far-end of sheath pipe take-up be provided with the take-up ring pass in a side opening of pipe section far away blocked by take-up lock silk, the near-end of sheath pipe take-up is temporarily fixed on the near-end controller, each take-up eye that the take-up of sheath pipe is passed on the peelable sheath pipe constitutes tightening structure, and can take the back releasing of take-up lock silk away; Take-up lock silk is located in the interior pipe and can slides along interior pipe, and its near-end is drawn from the near-end controller.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described peelable sheath pipe is the tubular cloth tubular construction, and its tube wall is the tube wall of sealing.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described peelable sheath pipe is the tubular reticulum tubular construction, and its tube wall is the tube wall that mesh is arranged.
A kind of apparatus for delivering of artificial heart stent valve; be characterized in that described outer protection mechanism is for comprising at least one line ball lock silk and a support line ball around knot and the thread depressing mechanism that can unhitch; the two composition can be around the knot and the thread depressing mechanism that can unhitch, can be with the provisional radial compression of stent valve.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, Guan Bingke slided along interior pipe in described line ball lock silk ran through, and its near-end is drawn from an arm of near-end controller; The near-end of described support line ball is drawn from an arm of near-end controller, its far-end is provided with wire loop, pipe was blocked by line ball lock silk in a side opening of pipe entered in the far-end wire loop passed, before in the far-end wire loop enters, managing side opening, support line ball alternative is in stent valve outside process, or pass the part that does not have diaphragm seal on the stent valve, passed by same or different line ball lock silks when on passing stent valve, not having the part of diaphragm seal midway and block, form around knot and can implement provisional radial compression to stent valve and can after taking line ball lock silk away, unhitch.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, also comprise the side wire leading pipe, described side wire leading pipe rises from the outside at interior pipe section far away middle part and with interior pipe section far away and links to each other, pipe stage casing in inwardly the pipe proximal direction extends to, in also can extending on nearly section of pipe or the near-end controller, the far-end of side wire leading pipe is between the distal openings of interior pipe and proximal open and outwards bending, and the side opening direction of the port direction of formation and interior pipe is angled.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described side wire leading pipe is one, maybe can be equipped with around knot and the thread depressing mechanism that can unhitch with peelable outer protection mechanism.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described side wire leading pipe is two, and can be equipped with around the knot and the thread depressing mechanism that can unhitch, and becomes 120 degree corners to arrange between the wire leading pipe of both sides.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, described locking silk runs through interior pipe, and its section far away is passed stay thimble of one or more support backguy with one or more support backguy locking, and near-end links to each other with sliding bar in the near-end controller lock fixed thread arm.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, described locking silk is two, and two locking silks lock one or more support backguy respectively and also link to each other with two sliding bars that lock in the silk arms of near-end controller respectively.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, the vestibule of pipe in described support backguy is passed, its far-end is provided with a stay thimble, its near-end is drawn from the backguy arm of near-end controller, its section far away is drawn outer section that forms the support backguy from a side opening of interior pipe, outer section same side opening of support backguy around pipe in entering behind network one circle, and by the locked silk locking of the stay thimble of its far-end.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, outer section of described support backguy passes respectively around network the time that the unitary opening of deformable of network, open line turn, sealed line eye and flexibly jointed chain ring, constitutes a lasso trick.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, described support backguy is three, the near-end of three support backguys is drawn from three backguy arms of near-end controller respectively, and the far-end of three support backguys is locked by same or different locking silks in three side openings of interior pipe respectively.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, in described three support backguys, the backguy of drawing from the near-end backguy arm of near-end controller, in the proximal open of pipe, from the backguy that the stage casing backguy arm of near-end controller is drawn, its far-end was connected in the middle side opening of interior pipe in its far-end was connected, from the backguy that the far-end backguy arm of near-end controller is drawn, its far-end is connected in the distal openings of interior pipe.
A kind of apparatus for delivering of artificial heart stent valve, be characterized in, also comprise Ultrasonic-B probe, this Ultrasonic-B probe be arranged on the rear end of conductor housing or be arranged near the distal openings of pipe or near the proximal open, pipe was drawn from the near-end controller in the lead that connects Ultrasonic-B probe passed.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, also comprises interim exhausting line, and this interim exhausting line is used for helping backguy to get back to the near-end controller when assembling.
The apparatus for delivering of artificial heart stent valve of the present invention makes it compared with prior art owing to adopted above-mentioned technical scheme, has following advantage and good effect:
1, can make stent valve rotation location; Can make the stent valve after the expansion obtain effectively fixing; Can reduce the valve leaflet wearing and tearing; Can reduce the friction of support backguy, prevent the backguy dislocation.
2, being provided with the locking silk can discharge by quick non-resistance stent valve between twice heart beating.
3, can be provided with peelable outer protection mechanism replaces harder epitheca pipe that defeated the putting of stent valve shielded.
4, can be provided with and to replace harder epitheca pipe that defeated the putting of stent valve shielded around knot and the thread depressing mechanism that can unhitch.
5, can be provided with the defeated journey of letting slip of Ultrasonic-B probe monitoring apparatus for delivering.
6, be provided with the backguy of middle Guan Yuzhong pipe, help apparatus for delivering and pass through aortic arch.
7, being provided with the interim exhausting line of the nearly section of backguy can help backguy to get back to the near-end controller before art.
The specific embodiment
Referring to Fig. 1 to Fig. 7; the apparatus for delivering 2 of artificial heart stent valve of the present invention comprises: interior pipe 51, wire leading pipe 61, conductor housing 65, support backguy 70, locking silk 75, near-end controller 80, middle pipe 88, outer protection mechanism 90,92,96 can also comprise Ultrasonic-B probe 87 and side wire leading pipe 99.
Referring to Fig. 1 a, cooperate referring to Fig. 2 a, Fig. 2 b, Fig. 2 c, Fig. 2 d, the interior pipe 51 in the apparatus for delivering 2 of artificial heart stent valve of the present invention is an elongate tubular structure.The cross section can be circle.Interior pipe 51 can be by good springiness, and the macromolecular material that intensity is high constitutes.Check the aerofluxus bubble before the transparent or semitransparent favourable Rhizoma Atractylodis Macrocephalae of interior pipe 51 colors.Interior pipe 51 length are 80-150cm, and its near-end 511 is external, and far-end 512 arrives the position of hearts nature valves.Interior pipe far-end 512 links to each other with conductor housing 65. Inner orifice chamber 52,54,54 ' links to each other with the taper light wall pipe chamber 651 of conductor housing 65.The structure of interior pipe 51 can have different schemes.The vestibules 52,53,54,54 ' that can have one or more distances to communicate in the interior pipe 51.
Referring to Fig. 2 a, the structure of interior pipe 51 can be for managing 51 in the single hole, and pipe 51 has only a big circular general vestibule 52 in the single hole.In big circular general vestibule 52, can be equipped with one or more wire leading pipes 61, one or more backguys 70 and one or more locking silk 75.Can slide mutually between their (61,70,75).Also can be equipped with one or more wire leading pipe 61, backguy pipe 71, lock fiber tube 76 in the big circular general vestibule 52, like this each line each advance corresponding pipe and do not intersect between mutual.A plurality of tubules 61,71,76 are combined as an antipriming pipe in the single hole pipe, can slide between each pipe.
Referring to Fig. 2 e, interior pipe 51 also can be made of spiral spring 57.Spring 57 can be made of monofilament 571, also can be made of multifibres.The diameter of spring wire 571 equals wall thickness, and interior external diameter can change, and section far away is thinner, in nearly section thicker.Spring wire 571 can constitute semi-ring 572d, 572p or domain 572c in the part, is equivalent to distal openings 516d, proximal open 516p and middle side opening 516c.The step pitch of spring 57 can be different: 1, equal filament diameter, spring can only prolong (extension spring); 2, greater than filament diameter, spring can prolong or shorten (stage clip).58 protections of macromolecular material pipe can be arranged outside the spring 57, reach: reduce external friction; Liquid does not leak outside; Macromolecular material pipe at least two ends closely link to each other with spring, and spring can guarantee fold resistance, but does not extend axially.
Referring to Fig. 2 b, interior pipe 51 also can be for managing in the diplopore, and pipe 51 has two tube chambers 53,54 in the diplopore.A small circular 0.035 " guidewire lumen 53 is for 0.035 " seal wire passes through, and is equivalent to wire leading pipe 61 and the common tube chamber 54 of big semilune passes through for support backguy 70, locking silk 75 and possible support line ball 98 and line ball lock silk 97.Between two tube chambers 53,54 is decentered distribution, and adhesion is fixing between each pipe does not slide.
Referring to Fig. 2 c, Fig. 2 d, interior pipe 51 also can be a porous inner tube, and porous inner tube 51 has a plurality of tube chambers 53,54 '.Antipriming pipe is on pipe basis, two holes big semilune tube chamber 54 to be further divided into two or more tubules chamber 54 '.A small circular 0.035 " guidewire lumen 53 is for 0.035 " seal wire passes through, be equivalent to wire leading pipe 61 and a plurality of tubules chamber 54 ' and pass through at separately tube chamber respectively for support backguy 70, locking silk 75 and possible support line ball 98 and line ball lock silk 97.Adhesion is fixing between each pipe does not slide.
Referring to Fig. 1 a, Fig. 1 b, cooperate referring to Fig. 5 a, Fig. 5 b, Fig. 5 c, Fig. 5 d, Fig. 6 a, Fig. 6 b, Fig. 6 c and Fig. 7, interior pipe section 513 far away is positioned at the nearside of pipe far-end 512.Pipe section 513 far away is positioned at man-made support valve 1 inboard in when assembling is carried, and is used for linking to each other with man-made support valve 1.Its internal diameter is about 1.5-2.5mm, and external diameter is about 1.8-3.0mm, and its length slightly is longer than the man-made support valve 1 under the compressive state.In pipe section 513 far away one or above side opening 516d, 516c, 516p are arranged on far and near varying level.Distal openings 516d, middle side opening 516c and proximal open 516p are all on the same plane of interior pipe with on one side, on concave surface limit 517.Distal openings 516d, middle side opening 516c are relative with upstream extremity 184, stage casing 15, the downstream 134 of man-made support valve 1 respectively with proximal open 516p.Distance between distal openings 516d and the proximal open 516p approximates the length under stent valve 1 compression.Side opening 516d, 516c, 516p or communicate with the general vestibule 52 of big circle of pipe 51 in the single hole, or communicate, or communicate simultaneously with support backguy tube chamber, locking fiber tube chamber, support line ball tube chamber and the line ball lock fiber tube chamber 54 ' of porous inner tube 51 with pipe 51 the general tube chamber 54 of big semilune in the diplopore.Far and near two side opening 516d, 516p supply with the independent opening that support backguy 70 is walked separately, also can be the unified openings that support backguy 70 and support line ball 98 share.Side opening 516d, 516c, 516p are used in the inner orifice chamber 52,54,54 ' backguy 70 and go out into and discharge with gas-liquid, as radiography in the art.Side opening on the same level also can have one or more.In the periphery of pipe side opening 516d, 516c, 516p reinforcing ring 55 is arranged, constitute by the good material of intensity height, frictional property such as metal or macromolecular material.Can increase backguy and slide, reduce pipe probability in the backguy cutting.The reinforcing ring 55 of metal material can constitute radiopaque marker.
Can there be braiding reinforcing mat 56 in interior pipe middle level, and interior pipe side opening 516d, 516c, 516p can open in a grid of braiding reinforcing mat 56.
Continuation is referring to Fig. 1 a, Fig. 1 b, and interior pipe stage casing 514 is positioned at the nearside of pipe section 513 far away.Bow shape is made in interior pipe stage casing 514 in advance, has constituted concave surface limit 517, interior pipe stage casing and convex surface limit 518.Be the arcual interior pipe of bow stage casing 514 and constituted datum plane.In pipe stage casing 514 do not link to each other with man-made support valve 1, its internal diameter and external diameter can be greater than the internal diameter and the external diameters of far away section 513 of interior pipe, but its external diameter should be less than the external diameter of compressive state man-made support valve.After internal diameter increased, the friction between the backguy 70 in it, the locking silk 75 reduced.After interior external diameter increased, interior pipe 51 bending resistances strengthened.Under external force, the bow shape of stage casing nature can be out of shape.
Continuation is referring to Fig. 1 a, Fig. 1 b, and the nearly section 515 of interior pipe is a straight tube, is the extension of interior pipe stage casing 514 proximads.The nearly section 515 of interior pipe stage casing 514 and interior pipe can be bourdon tube or braiding reinforced pipe 56.The near-end 511 of interior pipe links to each other with near-end controller 80.
Referring to Fig. 1 a, cooperation is referring to Fig. 2 a, Fig. 2 b, Fig. 2 c, Fig. 2 d, wire leading pipe 61 in the apparatus for delivering 2 of artificial heart stent valve of the present invention can have two kinds of schemes: 1, in a vestibule pipe be provided with in 51 one independently internal diameter can lead to 0.035 " wire leading pipe 61 of external diameter seal wire; this wire leading pipe 61 always with interior tubular axis line parallel; and come out from interior pipe far-end 512 and near-end 511 respectively; be positioned at protruding side 518 in interior pipe stage casing 514; wire leading pipe far-end 611 links to each other with the seal wire pore 652 of conductor housing 65, near-end links to each other with seal wire arm 86 on the near-end controller 80; 2, in two vestibules or porous intracavity pipe 51, be provided with a small circular guidewire lumen 53, form the fixing wire leading pipe 61 on inner pipe of an adhesion, its internal diameter can lead to 0.035 " the external diameter seal wire; this small circular guidewire lumen 53 is positioned at protruding side 518 in interior pipe stage casing 514; small circular guidewire lumen far-end 531 links to each other with the seal wire pore 652 of conductor housing 65, and near-end 532 links to each other with seal wire arm 86 on the near-end controller 80.
Referring to Fig. 1 c, cooperate referring to Fig. 1 a, Fig. 1 b, the conductor housing 65 in the apparatus for delivering 2 of artificial heart stent valve of the present invention is positioned at the distally of pipe far-end 512, can be the part of interior pipe.Conductor housing 65 is streamlined hollow cone body structure, its big end 654 is connected with interior pipe far-end 512 for the rear end, its small end 653 communicates with wire leading pipe 61 or small circular guidewire lumen 53 for front end is provided with thread eye 652, and small end 653 is the hollow light wall pipe of a taper, and soft and thin tube wall 655 is arranged.The leading portion of conductor housing 65 is provided with the vestibule 52,54,54 ' that one or more side openings 657 communicate with interior pipe distance and communicates, for the flushing final vacuum, wear the lock silk.Big end 654 links to each other with interior pipe far-end 512.Conductor housing 65 is made of softish macromolecular material, can contain the opacity material, or is embedded with radiopaque marker.
Referring to Fig. 1 a, Fig. 1 b, Fig. 1 d, cooperation is referring to Fig. 4 a, Fig. 4 b, Fig. 4 c, Fig. 4 d, Fig. 5 a, Fig. 5 b, Fig. 5 c, Fig. 5 d, and the support backguy 70 in the apparatus for delivering 2 of artificial heart stent valve of the present invention is fine rules of being made by macromolecular material or metal material.Require good springiness, do not have or very little plastic deformation, under pulling force, do not have or have only very little extension, do not have or have only very little cold plastic deformation.A support backguy 70 has a stay thimble 701, stay thimble 701 is positioned at the far-end 702 of backguy, can be the thin ring of 360 ° of sealings or the open semi-ring of the terminal 180 ° of discounting of two-wire, stay thimble 701 be arranged within one that manages distal openings 516d, side opening 516c and proximal open 516p and by a locking silk 75 and blocks.The outer section 703 of backguy is the continuity of stay thimble 701, be positioned at aforementioned pipe side opening 516d, 516c, outside the 516p, the outer section 703 of backguy can be two-wire, also can become and be single line, for assembling man-made support valve 1 on apparatus for delivering 2, the outer section 703 of backguy need be passed deformable unit 101 openings of support 10 or open line and be turned 102 or sealed line eye 103, arrive the support outside at least once, through other deformable unit 101, pass stent valve flexibly jointed chain ring 41, pass same or different deformables unit 101 openings or open line again and turn 102 or sealed line eye 103, get back to the support inboard, constitute a lasso trick 704.Backguy section 705 far away is 703 continuities to apparatus for delivering near-end 511 of the outer section of backguy, backguy section 705 far away is got back within aforementioned same or different interior pipe side opening 516d, 516c, the 516p, be positioned within the pipe section 513 far away, backguy section 705 far away also can be positioned within far away section 513 specific backguy vestibule of pipe 54,54 '.Can in aforementioned, manage side opening 516d, 516c, 516p slip between outer section 703 of backguy and the backguy section 705 far away.Backguy stage casing 706 is 705 continuities to apparatus for delivering near-end 511 of backguy section far away, be positioned at pipe stage casing 514 or specific backguy vestibule 54, within 54 ', it is two-wire that the stage casing 706 of backguy can be continued, also can become single line, also can link to each other with other material, reach good springiness, not prolong under the equal pulling force from certain-length.The nearly section 707 of backguy is the continuity of backguy stage casing 706 to apparatus for delivering near-end 511, and to the apparatus for delivering proximal extension, relevant backguy arm 81d, 81c, the 81p of the nearly section 707 of backguy from near-end controller 80 comes out in the nearly section 515 of interior pipe.Backguy near-end 708 is positioned at outside relevant backguy opening 81d, 81c, the 81p.Each apparatus for delivering 2 can have one or more support backguys 70,70d, 70c, 70p.Each stay thimble 701 is blocked by same or different locking silk 75,75c.Each backguy 70d, 70c, 70p outer section 703 respectively from interior pipe distal openings 516d, side opening 516c and proximal open 516p come out, its stay thimble returns behind support in each opening.Each backguy near-end 708 comes out from each backguy arm 81d, 81c, the 81p of near-end controller 80.Each backguy near-end 708 can two-in-one or three-in-one concentrating be backguy combination 709 outside each backguy arm 81d, 81c, 81p.
Referring to Fig. 1 b, Fig. 1 d, cooperate referring to Fig. 2 a, Fig. 2 b, Fig. 2 c, Fig. 2 d and Fig. 5 a, Fig. 5 b, Fig. 5 c, Fig. 5 d, one or two or more locking silks 75,75c can be arranged in the apparatus for delivering 2 of artificial heart stent valve of the present invention.Each locking silk can lock one or more backguys 70,70d, 70c, 70p.Two covers or above locking silk 75, the 75c of two covers can work together, also can work independently respectively.Locking silk 75 is positioned within inner orifice chamber 52 or the specific locking silk vestibule 54,54 '.Two or more locking silks 75,75c can be positioned within same inner orifice chamber 52,54 or the specific separately locking silk vestibule 54 '.Two or more lockings silk 75,75c accounts for an inner chamber but two or more locking silk 75,75c distal length are the same.Each locking silk 75 far-end 751 is all above interior pipe distal openings 516d.Locking silk 75 passes stay thimble 701 in section far away can not deviate from it from interior pipe side opening 516d, 516c, 516p.Locking silk 75 proximal direction are extended, and come out from the locking silk arm 83 of near-end controller 80, and one or above locking silk 75 come out from different or a same locking arm 83 respectively.Locking silk near-end 752 links to each other with the slide bar head 844 of locking silk arm 84.Locking silk 75,75c can slide in interior pipe 51.
Referring to Fig. 1 d, the near-end controller 80 in the apparatus for delivering 2 of artificial heart stent valve of the present invention links to each other with the near-end 511 of interior pipe.Near-end controller 80 comprises main pipe and a plurality of arm 81d, 81c, the 81p, 84,85,86 that are connected thereon.Vestibule 52 that these arms and interior pipe 51 are general or specific separately vestibule 54,54 ' communicate.These arms can also can come out by angled bifurcated on the axis of interior pipe 51.Comprise: one or more backguy arm 81 (81d, 81c, 81p); One or more locking silk arm 84; Flushing and radiography arm 85, with preceding two kinds of arms 81,84 and in the general vestibule 52 of pipe or specific separately vestibule 54,54 ' communicate; One or more seal wire arm 86, general vestibule 52 of pipe or specific separately vestibule 54,54 ' communicated in seal wire arm 86 can reach with above-mentioned three kinds of arms 81,84,85.Seal wire arm 86 also can different above-mentioned three kinds of arms 81,84,85 and in the general vestibule 52,54 of pipe communicate, and only communicate or the small circular 0.035 of porous inner tube with wire leading pipe 61 inner chambers " guidewire lumen 53 communicates.
Backguy arm 81 can have one, two or more.Backguy arm 81 can be at the side angle of near-end controller 80, also can be at the end on the axis of near-end controller 80.Each backguy arm 81 generally is to walk a backguy, and far-end backguy 70d comes out from far-end backguy arm 81d, and backguy 70c in stage casing comes out from stage casing backguy arm 81c, and near-end backguy 70p comes out from near-end backguy arm 81p.Two or more backguys 70 also can be come out from same backguy arm 81.In the backguy arm 81 resistant to blood refluence film 811 can be arranged, be made of the elasticity macromolecular material, the centre has a pin hole 812 to allow backguy 70 pass through.Backguy fastener 82 is arranged on the backguy arm 81, a certain ad-hoc location of backguy 70 can be fixed on the backguy arm 81.Backguy arm 81 can be the male and female threaded relation with the relation of backguy fastener 82.Backguy is tied up between the male and female screw thread.Backguy fastener 82 can be a solid stopper, and plug is stuck in backguy on the backguy opening in the backguy opening.Backguy fastener 82 also can be a rotation stopper 822 that backguy passage 821 is arranged, and after rotation stopper 822 and backguy arm 81 rotate, backguy is stuck on the backguy arm.
One or more locking silk arm 84 is arranged on the near-end controller 80.Locking silk arm 84 can be terminal on near-end controller axis, also can be in the side.Be provided with the resistant to blood film 831 that backflows on the connector 83 of main pipe and locking silk arm 84, be made of the elasticity macromolecular material, there is a pin hole 832 centre, can allow locking silk 75 pass through.On the connector 83 of main pipe connect mechanism 833 is arranged, as female thread, can with the connect mechanism 842 of locking silk arm 84, as external screw thread, link fixing.Do not having under the fixed situation, sliding in the pipe 51 in locking silk 75 can reach in locking silk arm 84.Being provided with a sliding bar 843 in the locking silk arm 84 can slide in the inner chamber 841 of locking silk arm 84.The front end 844 of sliding bar links to each other with locking silk near-end 752, the rear end protruded tube of sliding bar forms operating grip outward, the middle part of sliding bar has a groove, position corresponding to this groove on the locking silk arm is provided with far-end dowel hole and proximally-located pin-and-hole, two alignment pins 848 can pass two dowel holes on the locking silk arm respectively and will locks a silk arm with groove on the sliding bar and link to each other with sliding bar, by fixing or the releasing alignment pin can determine whether the locking silk of sliding bar and connection thereof slides and control its sliding distance.Alignment pin 848 is divided into far-end alignment pin 848d and proximally-located pin 848p, the distance in the distance between two alignment pins is less than between the pipe respective openings.One or more alignment pin 848 can prevent that locking silk 75 proximads from moving.After an alignment pin 848 is removed, but locking silk 75 proximads move a certain distance.
Near-end controller 80 is provided with flushing radiography arm 85, is furnished with switch 851 on it.
One or more seal wire arms 86 can be arranged on the near-end controller 80.Seal wire arm 86 is on near-end controller 80 terminal axis.Seal wire arm 86 separates with above-mentioned three arms 81,84,85 and the general vestibule 52 of interior pipe, and only communicates with wire leading pipe 61 or guidewire lumen 53.The diaphragm seal that is made of the elasticity macromolecular material is arranged on the seal wire arm 86, a pin hole is arranged on the diaphragm seal, distortion relief seal wire passes through.The normal condition lower pinhole is closed, and does not leak blood.
Referring to Fig. 1 c, Ultrasonic-B probe 87 in the apparatus for delivering 2 of artificial heart stent valve of the present invention is arranged on the rear end 654 of conductor housing 65, or manage in being arranged on the section 513 far away, as establishing one or more Ultrasonic-B probe 87 by selectivity near the distal openings 516d or near the proximal open 516p.Lead to near-end controller 80 and joint 872 is arranged on the pipe 51 in the lead 871 of Ultrasonic-B probe 87 is attached to.
Referring to Fig. 6 a, Fig. 6 b, Fig. 6 c, Fig. 7; also be provided with side wire leading pipe 99 in the apparatus for delivering of artificial heart stent valve of the present invention; this side wire leading pipe 99 and peelable outer protection mechanism or with can be equipped with around knot and the thread depressing mechanism 96 that can unhitch, can selectivity in interior pipe section far away 513 outsides fix one or more internal diameters and can lead to 0.014 " the side wire leading pipe 99 of external diameter seal wire.Extend at least to interior pipe stage casing 514 by proximad 511 directions from the outside at interior pipe section far away 513 middle parts for 99 of side wire leading pipes, also can arrive on nearly section 515 of interior pipe or the near-end controller 80.Side wire leading pipe 99 can link to each other with the nearly section 515 of interior pipe stage casing 514 and interior pipe, also can not link to each other.Side wire leading pipe far-end 991 is at the middle part of interior pipe section 513 far away, and between interior pipe distal openings 516d and the interior pipe proximal open 516p, unfixing have several millimeters length to separate with interior pipe section 513 far away on inner pipe, is free active state.Side wire leading pipe middle part 992 is fixed with interior pipe section 513 far away, and the near-end 993 of side wire leading pipe is at the nearside of interior pipe proximal open 516p.Side wire leading pipe pore 994 sizes can allow 0.014 at least " the diameter seal wire passes through.Rotary angle position between side wire leading pipe 99 and interior pipe side opening 516d, the 516p can determine in advance that if any two or more side wire leading pipes 99, the rotary angle position between them also can be determined in advance.Different side wire leading pipe far-ends 991 can be at same level or varying level, such as on cross section, a left side wire leading pipe 99 becomes about 60 degree (45-75 degree) corners with interior pipe side opening 516d, 516p, another right side wire leading pipe 99 becomes about 180 degree corners with interior pipe side opening 516d, 516p, become 120 degree corners between the both sides wire leading pipe 99.Both sides wire leading pipe 99 can have only wherein any one.Become 120-180 degree corner as right side wire leading pipe 99 with interior pipe side opening 516d, 516p, or become 0-60 degree corner with interior pipe side opening 516d, 516p as left side wire leading pipe 99.0.014 " side wire leading pipe 99 strengthened the intensity at interior pipe proximal open place.0.014 " position of side wire leading pipe 99 and length guaranteed to use lack (1.5m) 0.014 " the external diameter seal wire makes quick exchange.
Referring to Fig. 3 a, cooperate referring to Fig. 1 a, Fig. 1 b, pipe 88 in being provided with in the apparatus for delivering 2 of artificial heart stent valve of the present invention, middle pipe 88 are tubular structural members independently, are positioned at pipe 51 outsides, can be along interior pipe 51 slips.Pipe 51 external diameters in middle pipe 88 internal diameters are slightly larger than are less than or equal to man-made support valve 1 external diameter under the compressive state.Middle pipe far-end 881 is less than interior pipe proximal open 516p; Middle pipe near-end 882 is near near-end controller 80.Pipe backguy 89 in one is arranged in the middle pipe 88, during being fixed on, the far-end 891 of middle pipe backguy 89 constitutes fixing point 893 on the pipe far-end 881, the side opening 884 that near-end 892 is therefrom managed near-end 882 comes out, and the far-end fixing point 893 of middle pipe backguy 89 and the side opening 884 of middle pipe near-end 882 are on same plane with on one side.After middle pipe backguy 89 tensions, tension force increases, and middle pipe 88 becomes curved, and support backguy 70 slides on the concave surface 517 of bending naturally, and this helps apparatus for delivering and passes through aortic arch.In middle pipe near-end 882 and the side opening 884 shrink-ring is arranged respectively, shrink-ring is the silica gel circulus, slides the certain position in being fixed in during deflation on the pipe when loosening along interior pipe.Middle pipe 88 colors are transparent or semitransparent, check the aerofluxus bubble before the favourable Rhizoma Atractylodis Macrocephalae.The intensity of the nearly section 514,515 of pipe in middle pipe 88 also is used for strengthening.In pipe 88 can be taper, section far away is thinner, nearly section is thicker, make apparatus for delivering obtain simultaneously nearly section promotion and in section bendability far away.Middle pipe 88 can be a braiding reinforced pipe.Middle pipe 88 slides along interior pipe, but the stent valve 1 under the middle pipe far-end 881 pushes compression states goes out epitheca pipe 90.
Referring to Fig. 3 b, Fig. 6 a, Fig. 6 b, Fig. 6 c, Fig. 7, the outer protection mechanism in the apparatus for delivering 2 of artificial heart stent valve of the present invention can have following three kinds of Scheme Choice:
1, the epitheca pipe 90
Epitheca pipe 90 is a tubular structure, is made of macromolecular material, and epitheca pipe 90 colors are transparent or semitransparent, has or not bubble after the inspection flushing before the favourable Rhizoma Atractylodis Macrocephalae.Epitheca pipe section far away 901 tube walls are thin, and internal diameter is slightly larger than the external diameter of the man-made support valve 1 under the compression, and its length is slightly larger than the length of the man-made support valve 1 under the compression.Section 901 compressions far away of epitheca pipe, protective cradle valve 1.Epitheca pipe far-end 902 has radiopaque sign 903 to be embedded in the tube wall.Epitheca pipe stage casing 904 can be with far away section 901 the same pipe, also can be tube wall thicker but internal diameter and external diameter all less than the pipe of section 901 far away, its internal diameter is uneven in length greater than the external diameter of middle pipe, in the case, section junctional area pipe 905 far away in is arranged between stage casing and the section far away.The nearly section 906 of epitheca pipe is the pipe that an external diameter increases, the internal diameter of pipe 88 during its internal diameter is equal to or greater than, and be provided with flushing/radiography opening and valve 907.Epitheca pipe near-end 908 has an elastica or manages 909, and there is a pin hole 910 in elastica 909 central authorities, and normal condition lower pinhole 910 is closed or had only very little diameter, middle pipe 88 to pass pin hole 910 diameters and can enlarge, and does not leak blood with 88 slips of pipe in guaranteeing and elastica 909.
2, peelable outer protection mechanism 92
It comprises: take-up lock silk 93, peelable sheath pipe 94 and sheath pipe take-up 95.Pipe 51 in the central authorities of peelable outer protection mechanism 92 have; far away section 513 of interior pipe has far away section distal openings 516d and proximal open 516p; these two side opening 516d, 516p supply with the independent opening that sheath pipe take-up 95 is walked separately, also can be the unified openings that share with support backguy 70.The stage casing of interior pipe and nearly section are the same.
Have at least one take-up lock silk 93 to slide along interior pipe 51 in the interior pipe 51, silk 93 is locked in take-up a far-end 931 and near-end 932, and a take-up lock silk near-end 932 can come out from near-end controller 80.
Outside the interior pipe 51 is peelable sheath pipe 94.Peelable sheath pipe 94 is and interior pipe 51 concentric tube-shaped structures to be arranged in outside pipe 51, man-made support valve 1 and the pipe 88.Can slide between peelable sheath pipe 94 and the interior pipe 51.Peelable sheath pipe 94 can be by natural or synthetic tubulose stringing 941 or 942 two kinds of forecast scheme configurations of tubulose webmaster that spin and be made into.The tube wall of tubulose stringing 941 is the tube wall of sealing, and the tube wall of tubulose webmaster 942 is the tube wall that mesh 943 is arranged, and the mesh tube wall can be braiding gauze or a crocheted net, and mesh diameter is less than 1mm, mesh 943 shape variable shapes, but constant with the length on limit.The far away section part 944 of peelable sheath pipe 94 and interior pipe section 513 far away is in same level and an axial or longitudinal opening 945 is arranged, on the longitudinal opening 945 both sides sheath pipes take-up eye 946 is arranged, be the opening of sealed tube wall or certain eye 943 in the mesh tube wall, mesh 943 periphery sealings are complete on the webmaster on the both sides of opening.The diameter of section 944 far away or girth can be consistent.The far-end 947 of section 944 far away or and the diameter or the girth of near-end 948 can be inconsistent, under the situation of curling, constitute far-end vertebra shape 947 ' and near-end vertebra shape 948 '.Far-end 947 diameters of peelable sheath pipe 94 are less, and it is streamlined to constitute bullet.Longitudinal opening 945 runs through far-end 947.A nearly section part 949 is a complete pipe or a pipe network in the peelable sheath pipe 94, and its diameter or girth are less than or equal to far away section 944 diameter or girth.Between interior pipe section 513 far away and peelable sheath pipe section 944 far away, can accompany stent valve 1.Do not show at Fig. 6 a, Fig. 6 b, Fig. 6 c medium-height trestle valve 1.Stent valve 1 is the same with interior pipe 51 combinations.
Peelable sheath pipe section 944 far away has longitudinal opening 945, and take-up eye 946 is arranged on the longitudinal opening limit.Under sheath pipe take-up 95 helped, the longitudinal opening 945 of peelable sheath pipe section 944 far away can provisionally tighten up, and the stent valve 1 in it vertically compresses.Far section 944 is in the distally and nearside and interior 51 provisional linking to each other of pipe of longitudinal opening 945 for peelable sheath pipe, and this moment, peelable sheath pipe 94 and 51 of interior pipes can not slide, and stent valve 1 vertically is being limited between these two.Sheath pipe take-up 95 has a far-end take-up ring 951 to pass interior of managing among distal openings or proximal open 516d, the 516p, is blocked by take-up lock silk 93.This sheath pipe take-up 95 can be passed stent valve 1 or outside stent valve (far away or nearside).95 one-tenth of sheath pipe take-ups are two, pass the take-up eye 946 of peelable sheath pipe section far away 944 longitudinal openings 945 both sides simultaneously, constitute the opposite single line line of both direction on first limit and turn 952, constitute a two-wire line on second limit and turn 953, the single line line turns 952 and constitutes and the vertical two-wire vertical section 954 of the sheath pipe longitudinal axis between turning 953 with the two-wire line.95 one-tenth pairs of sheath pipe take-ups are turned 953 from the two-wire line and are continued to walk then to constitute two-wire parallel-segment 955 along the longitudinal axis, constitute a take-up semi-ring 956 to adjacent take-up eye 946 places.Pilot process is shown in Fig. 6 a, Fig. 6 b, Fig. 6 c.The other end of sheath pipe take-up 95 is turned 952 from the single line line and is continued proximads or single line parallel-segment 957 is walked to constitute in the distally, becomes two take-up eye 946 and aforesaid take-up semi-rings 956 that pass longitudinal opening 945 both sides successively to constitute another take-up semi-ring 956 to another adjacent take-up eye 946 places at next take-up eye 946 places.Take-up semi-ring 956 is turned 953 by two-wire 95 follow-up two-wire lines and blocks.Repeat with this: the single line line turns 952 1 two-wire vertical sections, 954 1 two-wire lines and turns 953 a pair of line parallel sections, 955 1 take-up semi-rings, 956 1 single line parallel-segment 957.The length of two-wire vertical section 954 is represented the radial compression level of sheath pipe take-up 95 degrees of tightness or stent valve 1.Pipe 51 another side opening 516p, 516d were blocked by same or another take-up lock silk 93 in last take-up semi-ring 956e entered.This take-up semi-ring 956e can pass stent valve 1, also can not pass stent valve and outside it nearside.Sheath pipe take-up 95 is softish fine rule, any two-wire line turn 953 and take-up semi-ring 956 can be out of shape, become straight, the position between sheath pipe take-up 95 each sections can change.Nearly section 958 can be led to relieving mechanism nearside 511 through nearly section 949 inboards or the outside in the peelable sheath pipe in the take-up of sheath pipe.Sheath pipe take-up near-end 959 is temporarily fixed on the near-end controller 80.Between peelable sheath pipe section far away 944 longitudinal openings 945 both sides, and between 95 two adjacent two-wire vertical sections 954 of take-up, the interim little opening 945s of sheath pipe that is interlinked to the outside in constituting, longitudinal opening 945 can be divided into the interim little opening 945s of a plurality of sheath pipes.Peelable sheath pipe 94 longitudinal openings 945 tighten up under the situation, one or above lateral guide fiber tube 99 or seal wire, " wire leading pipe; can be from interior pipe 51; from inside to outside, pass the part of not sealing film on the stent valve 1 passes interim little opening 945s of sheath pipe or longitudinal opening 945 and comes out; enters the collateral artery opening, as coronary ostium as 0.014.If have only a longitudinal opening 945, lateral guide fiber tube 99 or seal wire can only come out to a direction opening on same cross section.
The operation principle of peelable outer protection mechanism 92 is as follows:
If a is pulled outwardly take-up lock silk near-end 932, take-up lock silk 93 slides to near-end, and take-up lock silk far-end 931 skids off far-end take-up ring 951 or last take-up semi-ring 956e, and sheath pipe take-up 95 is not blocked and obtained to discharge by take-up lock silk 93.
B, pulling take-up near-end 959, two-wire 953,954,955,956 can withdraw from the d/d two-wire ring 956 in back that is stuck earlier, the both sides of removing the longitudinal opening 945 of peelable sheath pipe 94 by opposite order connect, peelable sheath pipe 94 becomes real longitudinal opening 945, and sheath pipe take-up 95 can all be received the apparatus for delivering near-end.
3, can be around knot and the thread depressing mechanism 96 that can unhitch
It comprises: line ball lock silk 97 and support line ball 98, the two composition can be around knot and the thread depressing mechanism 96 that can unhitch.Being in can be ditto described around interior pipe 51 structures in knot and the thread depressing mechanism 96 that can unhitch.Pipe 51 can have a big circular general vestibule 52 in the single hole; Pipe 51 can have two tube chambers, one 0.035 in the diplopore " guidewire lumen 53 is for 0.035 " seal wire passes through and big semilune general tube chamber 54 voltage supply lines lock silk 97 and support line ball 98 pass through.Porous inner tube 51 can have a plurality of tube chambers, one 0.035 " guidewire lumen 53 is for 0.035 " seal wire passes through and a plurality of tube chamber 54 ' voltage supply line lock silk 97 and support line ball 98 pass through at separately tube chamber respectively.Interior pipe section 513 far away has at least two openings, distal openings 516d and proximal open 516p.Two openings or communicate with the interior tube chamber 52 of pipe in the single hole, or communicate with the general tube chamber 54 of pipe in the diplopore, or communicate simultaneously with the support line ball tube chamber 54 ' and the line ball lock fiber tube chamber 54 ' of porous inner tube.Distance between two openings approximates the length under the stent valve compression, and these two side opening 516d, 516p supply with the independent opening that support line ball 98 is walked separately, also can be the unified openings that share with support backguy 70.
In single hole in the interior tube chamber 52 of pipe, or in the diplopore in the common tube chamber 54 of pipe, or in the line ball of the porous inner tube lock fiber tube chamber 54 ', one or more line ball lock silk 97 is arranged, 511 run through from far-end 512 to near-end.Line ball lock silk 97 has a far-end 971 and near-end 972, and near-end 972 can come out from an arm of near-end controller 80.Line ball lock silk 97 can be along interior tube chamber 52, or along common tube chamber 54, or slides along line ball lock fiber tube chamber 54 '." seal wire comes out between stent valve 1 middle part and support line ball 98 each sections in that 99 guiding 0.014 of two side wire leading pipes can be arranged on same level or the cross section.
In the far away section of pipe 513 is outer that the stent valve that will be transferred 1 that entangles is with one heart arranged, stent valve 1 is not included in the apparatus for delivering 2, but stent valve 1 is discharging anteposition in thread depressing mechanism 96 structures.In stent valve 1 can be temporarily anchored to by aforesaid support backguy 70 on pipe 51 the same side opening or other side opening 516d, 516c, the 516p.
Stent valve 1 can be by support line ball 98 provisional radial compression.Support line ball 98 is a deformable fine rule of softness, is positioned at stent valve 1 outside.One end of support line ball 98 has far-end wire loop 981, manages among distal openings or proximal open 516d, the 516p in far-end wire loop 981 passes, and enters or interior tube chamber 52 or common tube chamber 54 or support line ball tube chamber 54 ', is blocked by line ball lock silk 97.In entering before far away or proximal open 516d, the 516p of pipe, far-end wire loop 981 alternatives are in stent valve 1 outside process, or pass the part that does not have diaphragm seal on the stent valve 1.Support line ball 98 extends at stent valve 1 outer surface, constitutes a single line line and turns 982.Support line ball 98 one-tenth two-wire 98a, 98a ' move on, around stent valve 1 about 360 degree, two-wire passes aforementioned single line line and turns 982 and constitute first two-wire lines and turn 983a, move on and constitute first line ball semi-ring 984a, support line ball 98 next section continue into two-wire 98b, 98b ' and spend around stent valve 1 about 180 along aforementioned opposite direction, pass second two-wire line of aforesaid first line ball semi-ring 984a formation and turn 983b, moving on constitutes second line ball semi-ring 984b.Repeat in this way, double bracket line ball 98 is first to a direction pitch of the laps at stent valve 1 outer surface, then to another opposite direction pitch of the laps, constitute the opposite two-wire line of other both directions and turn 983c, 983d and other two line ball semi-ring 984c, 984d, a back two-wire line turns 983d and passes previous line ball semi-ring 984e.Such two-wire unit can repeatable countless times.Support line ball 98 is softish fine rule, any two-wire line turn 983 and line ball semi-ring 984 can be out of shape, become straight, the position between them can change.But support line ball 98 two-wire in the process of shuttling back and forth, turn between 983a, 983b, 983c, 983d...983x and line ball semi-ring 984a, 984b, 984c, the 984d...984x at any one two-wire line, passing stent valve 1 does not simultaneously have the part of coverlay, from outside to inside, and then from inside to outside, support line ball 98 and stent valve 1 is together temporary fixed.Last line ball semi-ring 984z, after passing previous line ball semi-ring 984x and constituting last two-wire line and turn 983z, pass pipe side opening 516p, 516d in the other end, enter or interior tube chamber 52 or common tube chamber 54 or support line ball tube chamber 54 ', blocked by same or another line ball lock silk 97.Before in entering, managing side opening 516p, 516d, this last line ball semi-ring 984z optionally passes outside stent valve 1, or pass the part that stent valve 1 does not have diaphragm seal, far-end wire loop 981 and last line ball semi-ring 984z passed by same or different line ball lock silks 97 block after, draw support line ball near-end 985 can tighten up line ball 98 and the radial compression stent valve 1 below it.Far-end wire loop 981 and last line ball semi-ring 984z passed by same or different line ball lock silks 97 block after, support line ball 98 is also optionally in the same way for the second time around knot stent valve 1, for the second time the support line ball 98 around knot stent valve 1 be the continuity of same line ball, for the second time around 98 sections of the support line balls of knot for the first time around the outside of tying 98 sections of support line balls.Trend around 98 sections of the support line balls of tying is opposite around the overall trend of 98 sections of knot support line balls with the first time for the second time, and gets back near the initial far-end wire loop 981.Can enter and pipe side opening or different interior pipe side opening 516p in far-end wire loop 981 is same for the second time, and be passed by another line ball lock threads 97 and to block around last line ball semi-ring 984z of 98 sections of the support line balls of knot.Nearly section 986 is optionally walked between interior pipe 51 and middle pipe 88 in the support line ball, or walks at interior pipe 51 intracavity.Line ball near-end 985 can with 80 provisional linking to each other of near-end controller.Can there be the middle pipe 88 that entangles in the concentric circular mode in nearly section 514,515 outsides in the interior pipe.Middle pipe 88 internal diameters are greater than interior pipe 51 external diameters, and pipe 88 can slide along interior pipe 51 in making.Can walk support line ball 98 between middle pipe 88 and the interior pipe 51.
Can be as follows around the operation principle of knot and the thread depressing mechanism 96 that can unhitch:
A, support line ball 98 tensions and blocked by line ball lock silk 97 after, tighten up support line ball 98 and make self expandable type stent valve 1 radial compression below it, diameter diminishes, and is compressive state or feed status;
B, under aforementioned compressive state, the middle and lower reaches section 15,13 that one or more lateral guide fiber tube far-ends 991 or side direction seal wire can pass stent valve 1 does not from inside to outside have the deformable unit 101 of diaphragm seal, between support line ball 98, arrive stent valve 1 outside, enter the inlet of collateral blood vessels, as coronary ostium.Behind one or more side direction seal wire approaching side branch blood vessels, can determine the rotation location of apparatus for delivering 2 and stent valve 1.Because line ball 98 area occupied are little, side wire leading pipe far-end 991 can be drawn a plurality of different side direction seal wires in Different Plane and different rotary angle.Side wire leading pipe far-end 991 enters the open zone 987 between support line ball 98 each sections, even the side direction seal wire that makes side wire leading pipe far-end 991 and connected at support line ball 98 under the situation that knot is removed, when support line ball 98 reclaims to near-end, can not block mutually between side direction seal wire and the support line ball 98.
C, one or more line ball lock silk 97 are moved to near-end successively, and line ball lock silk far-end 971 skids off last line ball semi-ring 984z and far-end wire loop 981, and support line ball 98 is released.Can remove two-wire line outside the stent valve 1 to near-end 511 pulling line ball near-ends 985 and turn line ball between 983a, 983b, 983c, 983d...983x and line ball semi-ring 984a, 984b, 984c, 984d...984x, and support line ball 98 all is recovered to near-end 511 around knot.The side direction seal wire is positioned at the open zone 987 of 98 of support line balls, and the support line ball 98 that is not moved influences.
The use of the apparatus for delivering of artificial heart stent valve of the present invention, operation principle and function can comprehensively be described as follows:
1, assembling
The assembling of man-made support valve and apparatus for delivering 2 comprises: the preparation of interior pipe backguy 70 and interim exhausting line 72; Backguy 70 perforating branches frame valves before the art, rotation pre-adjustment during assembling; Backguy 70 is got back to near-end controller 80 before the art under interim exhausting line 72 helps.For this process is simplified minimum level, two kinds of selectable schemes are arranged:
A, shown in Fig. 5 c, Fig. 5 d, interior pipe 51 internal lock silks 75 have put in place.Interior pipe each side opening 516d, 516c, the last backguy 70 of 516p are pinned by lock silk 75.But the outer section 703 of backguy is outside interior pipe.Also have near section interim exhausting line 72 of backguys in the interior pipe 51, it reclaims ring 721 outside side opening 516d, 516c, 516p, and exhausting line 72 is in interior pipe, and interim exhausting line near-end 722 extends to near-end controller 80 and stretches out from its specific backguy arm 81.Backguy 70 pass open line certain on the support turn 102 or sealed line eye 103 after, pass the recovery ring 721 of interim exhausting line 72, draw interim exhausting line near-end 722, by interim exhausting line 72 708 recovery of backguy near-end are moved to outside the specific backguy arm 81 of near-end controller 80, the interior exhausting line 72 temporarily of pipe changes backguy 70 in realizing.
B, identical with a, but backguy 70 pass open line on the support turn 102 or sealed line eye 103 backs be linked to be a long backguy 70 with interim exhausting line 72 knottings.Each side opening 516d, 516c of interior pipe section 513 far away, 516p are on same reference plane RP.Stent valve under the help of backguy 70 and locking silk 75, be fixed and radial compaction to interior pipe 51.Backguy 70 passes, pierce into that deformable unit on the stent valve girth, the anglec of rotation relation of side opening 516d, 516c, 516p or the reference plane RP of stent valve and interior pipe section far away just can determine, and with half to one deformable unit girth unit level definite anglec of rotation of adjustment when the external assembling in advance.Each apparatus for delivering 2 can have following combination that far-end, middle part and the near-end of backguy 70 at stent valve temporarily anchored on the interior pipe 51 of apparatus for delivering 2: 1, single stay 70 and monolock silk 75; 2, Duola's line 70 and monolock silk 75; 3, two covers or above independent monolock silk 75 and corresponding backguy 70.
2, radial compression
The radial compression of man-made support valve comprises: stent valve compression, backguy 70 tension after-poppet valve radial compression; Enter an outer protection mechanism 90 or 92 or 96, radial compression lower carriage valve enters epitheca pipe 90 or peelable outer protection mechanism 92 maybe can be around knot and the thread depressing mechanism 96 that can unhitch.
3, enter
Man-made support valve and entering of apparatus for delivering 2 comprise:
3.1, prepare before inserting: insert that one 0.035 " seal wire enters left ventricle; Using the peelable outer protection mechanism 92 maybe can be under thread depressing mechanism 96 situations that knot also can unhitch, can inserting one or two in case of necessity, 0.014 " seal wire enters a left side or right coronary artery.
3.2, corresponding seal wire enters corresponding wire leading pipe 61,99.
3.3, apparatus for delivering 2 is along the seal wire intravasation, epitheca pipe 90 or peelable outer protecting tube mechanism 92 maybe can be around the stent valve intravasations under knot and the thread depressing mechanism that can unhitch 96 protections.
3.4, enter aortic arch before, epitheca pipe 90 halts, compressed stent valve and interior pipe 51 and in pipe go out epitheca pipe 90 and move on.
3.5, slide between interior pipe and middle pipe.
3.6, the compressed stent valve descended aortic arch in no epitheca pipe 90 situations.
3.7, after backguy 70 tension, backguy 70 tensions in the interior pipe 51, shorten, and interior pipe itself can not axial compression.Manage section 513 far away and middle reaches section 514 in the apparatus for delivering 2 because softer, so just make straight interior pipe become curved, and interior pipe middle reaches section 514 flexibility that are made as bow shape are in advance strengthened, then be arc, particularly interior pipe middle reaches section 514 is in aortic arch.Interior pipe section 513 far away has the reinforcing of compression lower carriage valve, and still linearly.The nearly section 515 of apparatus for delivering is reinforced because of having than thick harder middle pipe, and still linearly.
3.8, the backguy 70 of tension simultaneously and lock silk 75 slide into naturally in pipe concave surface limit 517, and straight seal wire and wire leading pipe are managed convex surface limit 518 in sliding into naturally.
4, the location of man-made support valve
Apparatus for delivering 2 is arciform interior pipe middle reaches section 514 and has constituted consistent with the aortic arch plane or relevant datum level RP, with two coronary ostiums of making peace the rotation reference plane of fixed space has been arranged, the side wire leading pipe 99 of apparatus for delivering 2 helps axial upstream and downstream and rotary angle position location.
5, the expansion but do not discharge
Backguy 70 is loosened in the no release property expansion of man-made support valve but lock silk 75 does not slide, man-made support valve radial dilatation, but do not discharge.
6, the possibility of expansion back recompression
Tension backguy 70, the man-made support valve radially recompresses.
7, discharge expansion
Locking silk 75 slides to near-end, relevant stay thimble 701 releases, and the release expansion of man-made support valve comprises: once discharge radial dilatation; Merogenesis discharges radial dilatation; Elder generation's far-end upstream extremity, middle reaches section then, back near-end downstream discharges to be expanded; Or outer circulus 155 of first middle reaches section or outer free tongue 156 discharge expansion, and behind the location, far and near then end discharges expansion.Discharge position adjustment in the expansion.
8, after the radial dilatation, before near-end discharges, the possibility of repress withdrawal epitheca pipe 90
Man-made support valve merogenesis discharges expansion, and is tapered before near-end discharges expansion.The man-made support valve can repress withdrawal epitheca pipe 90.
9, fixing
The man-made support valve is fixed on ad-hoc location.
In sum, the apparatus for delivering of artificial heart stent valve of the present invention has following characteristics and advantage:
1, can make stent valve rotation location
Interior pipe section far away side opening 516d, 516c, 516p are all on the same anglec of rotation.After backguy 70 tensions, interior pipe middle reaches section 514 becomes curved under backguy 70 pulling force effects, interior pipe section far away side opening 516d, 516c, 516p have arrived the concave surface 517 of curved interior pipe naturally, backguy 70 and lock silk 75 slide into the recessed side 517 of bend pipe naturally, 0.035 " wire leading pipe 61 or guidewire lumen 53 slide into the protruding side 518 of bend pipe automatically under straight seal wire effect, be arranged off-centre.During particularly by aortic arch, interior like this pipe stage casing 514 becomes in backguy tension back bends, and has determined the datum level RP consistent with aortic arch.This datum level or interior pipe section far away side opening 516d, 516c, 516p and two arteria coronaria open C A have fixed rotation relationship.On pipe section far away side opening 516d, 516c, the 516p, the rotation relationship between the two can half external in advance rotation adjustment in deformable unit 101 in stent valve can be fixed to.
2, be provided with locking silk 75, the locking silk 75 of apparatus for delivering 2 can discharge by quick non-resistance stent valve between twice heart beating.Locking silk 75 can be from as far as discharging closely according to the order of sequence.Two or above locking silk 75 can discharge by selectivity.
3, can be provided with peelable outer protection mechanism 92, peelable sheath pipe 94 and the take-up 95 of sheath pipe in the peelable outer protection mechanism 92 are soft and thin, can replace harder epitheca pipe 90.Sheath pipe take-up 95 can be passed stent valve.On the same cross section in stent valve middle part, can walk a side direction seal wire through side wire leading pipe 99.
4, can be provided with can be around knot and the thread depressing mechanism 96 that can unhitch
Can replace harder epitheca pipe 90 around knot and thread depressing mechanism 96 good bandabilities that can unhitch.Support line ball 98 can pass stent valve, and support line ball 98 can tighten up the radial compression stent valve, on the same cross section in stent valve middle part, can walk one or more side direction seal wire through side wire leading pipe 99.
5, be provided with Ultrasonic-B probe 87, on the interior pipe section 513 far away one or more Ultrasonic-B probe 87 can be arranged optionally.
6, be provided with middle pipe 88 and middle pipe backguy 89, after middle pipe backguy 89 tensions, tension force increases, and middle pipe 88 becomes to be bent, and helps apparatus for delivering and passes through aortic arch.Middle pipe 88 slides along interior pipe, but the stent valve under the middle pipe far-end 881 pushes compression states goes out epitheca pipe 90.
7, be provided with the interim exhausting line 72 of the nearly section of backguy, interim exhausting line 72 can help backguy 70 to get back to near-end controller 80 before the art.