CN101961273B - Valvular prosthetic replacement device with buffer action and stent - Google Patents
Valvular prosthetic replacement device with buffer action and stent Download PDFInfo
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- CN101961273B CN101961273B CN2010101507617A CN201010150761A CN101961273B CN 101961273 B CN101961273 B CN 101961273B CN 2010101507617 A CN2010101507617 A CN 2010101507617A CN 201010150761 A CN201010150761 A CN 201010150761A CN 101961273 B CN101961273 B CN 101961273B
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- support
- prosthetic replacement
- valvular prosthetic
- stent
- valve
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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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a valvular prosthetic replacement device with a buffer action and a stent. The stent comprises an aorta stent, a valve stent and a flowing channel stent. The stent is provided with a transition section stent and has a mesh-shaped cylindrical structure formed by sequentially connecting the aorta stent, the transition section stent, the valve stent and the flowing channel stent. The top edge of the aorta stent is provided with at least two fixing lugs. The top edges of the fixing lugs are different from each other in height. A transition section is arranged between the valvular prosthetic replacement device and the stent of the invention and can have a buffer action, protect the valve stent and an internal three-leafvalve and ensure seal performance for long-term use. The valvular prosthetic replacement device of the invention has good positioning effect, not only reduces the difficulty of surgery but also realizes recycling.
Description
Technical field
The present invention relates to technical field of medical instruments, relate in particular to a kind of valvular prosthetic replacement's device.
Background technology
, because causing variation, congenital or acquired disease when causing valve normally not open and close, can impact when patient's self cardiac valve healthy living and even life.Valvular variation can be divided into open incomplete and incompetence, and both of these case can cause cardiac load to increase, and whether heart can also operate as normal be whether decider's systemic heart valve should metathetical main foundation under this load.
When patient need change valve, existing method was to adopt surgical operation to change lobe, and the doctor will open breast with cardiac arrest for patient, is attempted by on the external cardiopulmonary circulatory system.Open the cardiac valve excision of heart of patient then, artificial replacement's lobe seam is put in position gone up again, at last heart and thoracic cavity are sewed up pathological changes.This is a very large operation process of wound, and certain mortality risk is arranged, and patients ' recovery is chronic, and health can't bear a lot of patients because operation wound is big, can not undergo surgery although need change lobe.
U.S. Pat 5370685, US5411552 discloses the method and the valvular prosthetic replacement's device that are used for non-open chest surgery replacement heart valve among US5718725 and the US6425916, and the breast that can reduce to perform the operation out changes wound and the misery that lobe causes.
A kind of displacement apparatus is also disclosed in Chinese invention patent application 200710007443.3 in addition; The network of processing by memory metal material; And seam put in this support can unidirectional opening the SANYE valve constitute; For the ease of the location of the use of support, referring to Fig. 1, the support in this technology is divided into the bigger aortic stents of diameter 1, less valve bracket 2 and moderate left ventricular outflow tract support 3 three parts of diameter of diameter; Support back in place is conformed to the cardiac structure characteristics, be difficult for dislocation.
When valvular prosthetic replacement's device is implanted heart by femoral artery; In Chinese invention patent application 200710007443.3 and U.S. Pat 2002/0151970A1, all mentioned conveyer device, the guiding through conveyer device makes that valvular prosthetic replacement's device is in place.
Conveyer device of the prior art is that valvular prosthetic replacement's device is fixed on the support fixing head; This support fixing head front end has fairshaped seeker, and the rear end is connected with conduit, when implanting; At first valvular prosthetic replacement's device card is incorporated in the support fixing head of conveyer device; Through conduit valvular prosthetic replacement's device is pushed to the valve position of pathological changes from the porch of blood vessel, discharges valvular prosthetic replacement's device again, valvular prosthetic replacement's device its support under the effect of body temperature can expand; With the blade of human body valve be pressed to accomplish on the blood vessel wall in place, and then with conduit and support fixing head and seeker extraction.
But conveyer device of the prior art only is dependence seeker contact blood vessel in the time of need turning when stretching in the human vas, under the stopping of blood vessel, realizes turning, but so might cause scratch or damage to the inwall of blood vessel or organ.Moreover after discharging valvular prosthetic replacement's device; Because valvular prosthetic replacement's device is the meeting spreading under the effect of body temperature; And in case find its in place or position words devious and just can't handle; Be difficult to realize that the adjustment of position or secondary are in place, the control accuracy during so not only to operation requires high, and has certain risk.
After valvular prosthetic replacement's device was put into heart in the prior art, aortic stents 1 was positioned on the Tricuspid valve lobe ring, and valve bracket 2 basically just is in the position of Tricuspid valve lobe ring; Efferent tract support 3 is in Tricuspid valve lobe ring below, the SANYE valve-open when flowing because blood makes progress, and the SANYE valve is closed when blood is downward; Because the effect of blood pressure can make aortic stents 1 compressive deformation further expand; Because aortic stents 1 is integrative-structures with valve bracket 2, the expansion of aortic stents 1 can drive valve bracket 2 distortion to a certain extent, and the SANYE valve is to stitch to put in valve bracket 2; Valve bracket 2 frequent distortion can make the also loosening thereupon even distortion of SANYE valve; Poor sealing when causing it to close, part blood refluxes, and further influences patient's heart burden.
Summary of the invention
The present invention provides a kind of SANYE valve of can avoiding loosening, has cushioning effect and is beneficial to the support of valvular prosthetic replacement's device of protecting valve bracket and the valvular prosthetic replacement's device that adopts this support.
A kind of support that has valvular prosthetic replacement's device of cushioning effect; Comprise aortic stents, valve bracket and efferent tract support; Be provided with the changeover portion support; The netted tubular construction that described aortic stents, changeover portion support, valve bracket and efferent tract support connect and compose successively, the top of described aortic stents be along being provided with at least two fixedly ears, and fixedly the height on the edge, top of ear is different between two for each.
The biovalve seam places the valve bracket section of support; The corresponding distortion of whole section support along with heart and aortal expansion and contraction; Relatively stable shaping and the opening and closing campaign thereof to valve of the shape of valve bracket section plays a part key, and the amoeboid movement of other sections of support directly has influence on the valve bracket section.Be delivered to valve bracket for the deformation that cushions aortic stents; Described changeover portion support its between aortic stents and valve bracket; Just played the cushioning effect that distortion is transmitted, the radial strength of changeover portion support is less than the radial strength of valve bracket and soft.That is to say the tensile strength of the tensile strength of changeover portion support less than valve bracket.
Deformation takes place in changeover portion support more easily, such as adopting more crooked and turnover, plays buffering and Absorption to the deformation of aortic stents like this, is unlikely to cause the deformation of valve bracket, firmness and sealing that protection SANYE valve seam is put.
Because the support of valvular prosthetic replacement's device generally all is a RF; The mesh-density of changeover portion support is less than the mesh-density of valve bracket; With the similar cell of shape is example; The cell area of changeover portion support is 3～6: 1 with the ratio of the cell area of valve bracket, preferred 3～4: 1.
The similar features of shape that refers to of the shape here is basic identical, only is variant on the size, for example can be all rhombus and each interior angle correspondence is identical, only is that the length of side is different.
Valvular prosthetic replacement's device need adopt the conveyer device of special construction when getting in the human body, for valvular prosthetic replacement's device is fixed on conveyer device, on the support of valvular prosthetic replacement's device, be provided with fixedly ear, is used for matching with conveyer device.
Described fixedly ear is positioned at the edge, top of support, promptly is positioned at the edge, top of described aortic stents, and for the ease of processing, described fixedly ear and support are the structures of one.
Fixedly the quantity of ear can have several, as preferably, has two～four; Be evenly distributed on the edge, top of aortic stents, but the fixing shape various ways of ear, and its common ground is by head and the cervical region that is used for this head is connected edge, aortic stents top; As its name suggests, comparatively speaking cervical region is thinner, and head is thicker; Head also can be that the top of cervical region forms through expansion or bending, so just can be fastened on the conveyer device.In theory if described head along the projected area of the axis direction of support greater than cervical region projected area just can guarantee that bracket clamp is combined on the conveyer device, can avoid support before release with respect to the displacement of conveyer device generation along the axis direction of support.For example, described fixedly ear can be the T-shape structure, fall structure such as " L " type.
When the quantity of fixing ear during greater than one; The top of a plurality of generally speaking fixedly ears is identical along the projected position on the axis of support; The height that is the edge, top of a plurality of fixedly ears is consistent, but can bring a problem like this, when being fixed to support on the conveyer device; Need be simultaneously that a plurality of fixedly ears are in place, acquire a certain degree of difficulty in the operation.
The invention provides a kind of optimized technical scheme, the top of a plurality of fixedly ears is interspersed along the projected position on the axis of support.The height that is the edge, top of a plurality of fixedly ears is inconsistent; And different between two, like this, when being fixed to support on the conveyer device; Can be successively that a plurality of fixedly ears are in place; At first be that the top is earlier in place along the highest fixedly ear, successively that all fixedly ears is in place highly from high to low according to the edge, top then, like this operation can be much convenient.
As preferably, inwardly draw in or the outer wall of this bottom and the parallel axes of support the bottom of described efferent tract support.
Because the bottom of prior art medium-height trestle expands outwardly; Promptly court tilts away from the direction of the axis of support; Such design is after valvular prosthetic replacement's device is positioned in the heart, and the bottom that its support extends out might contact or strike wall of the heart, and the position of wall of the heart near bracket bottom is sinuatrial node just; Sinuatrial node sends stable bioelectric current and is passed to cardiac muscle, just makes heart keep rhythmical beating.In case and frame bottom contact or strike sinuatrial node will to make sinuatrial node send bioelectrical signals no longer stable directly causes arrhythmia, and patient is caused further harmful effect.
Inwardly draw in the bottom of described efferent tract support or the parallel axes of its outer wall and support can be avoided the stimulation to sinuatrial node, belongs to same design philosophy, but inwardly draw in as the engage in this profession bottom of support of preferred streams.
Aortic stents, valve bracket and efferent tract support can be self-expanding formulas or by the inflation formula.
The height of bottom described here is 1～3cm; Can be slightly variant according to the size of support overall dimension, can be when inwardly draw in described bottom along straight path, and the angle of the axis of this gathering position and support is 10～30 degree; Preferred as further; The angle of the axis of this gathering position and support is 15～20 degree, and suitable angle not only can have been avoided the stimulation of sinuatrial node but also can keep the proper supporting direction, guaranteed the unimpeded of blood runner.
Also can be when inwardly draw in described bottom along arc trajectory, the angle of the axis of the line of this camber line Origin And Destination and support is 10～30 degree equally, and is preferred as further, the angle of the line of this camber line Origin And Destination and the axis of support is 15～20 degree.
Because the SANYE valve in valvular prosthetic replacement's device is unidirectional opening; But the SANYE valve is closed during blood back flow; But because the pressure of blood of human body can make whole pressurized of valvular prosthetic replacement's device and extruding downwards; Valvular prosthetic replacement's device might be shifted downwards gradually, depart from original position.
In order to address this problem; The invention provides a kind of valvular prosthetic replacement's device of good stability in place; Be provided with the location thorn at the position that described valve bracket or efferent tract support contact with heart, this location is stung from the outer wall of valve bracket or efferent tract support is downward-sloping and is stretched out and away from the support axis.
As preferably, the angle of inclination that relative support axis is stung in described location is 15～45 degree.
Described location thorn can be that to be structure as a whole with support also can be to be welded on the support, and the shape of location thorn is not strict with, but need have at least one tip; The location thorn can have several; Being distributed in the outer wall of valve bracket or efferent tract support, generally is the axis uniform distribution around support, and one or more layers can be arranged; When multilamellar was arranged, the location of adjacent layer thorn preferably was dislocatedly distributed.
Preferred as further, the length of described location thorn is 0.3～1.5cm, for just with processing, can the node of the unit grid of support be cut, the freely swinging part of this node top is turned up and has just been formed the location thorn.
Preferred as further, described location thorn has 3～6, is evenly distributed on the position that valve bracket or efferent tract support contact with heart.
The present invention also provides a kind of valvular prosthetic replacement's device, comprises support of the present invention and the SANYE valve that is fixed in this support.
Described SANYE valve seam is put the inwall at valve bracket, and the SANYE valve can adopt the material of prior art and the seam method of putting to fix.
The present invention also provides a kind of being used for that valvular prosthetic replacement's device is delivered to the intravital conveyer device of people, comprising:
Seeker;
Sheath in piped;
The support fixing head of band through hole, the outer wall of the fixing first end of support has the locating slot that matches with the support of valvular prosthetic replacement's device, and the other end is connected with interior sheath;
Hauling rope, an end are connected with seeker after passing the through hole of support fixing head, and the other end passes interior sheath;
Piped epitheca, sheath and support fixing head are outside in being enclosed within.
Described seeker is a pyramidal structure; The termination portion of seeker has streamlined contour, can avoid scratching blood vessel, also helps guiding whole conveyer device to advance along blood vessel; The afterbody of seeker is a planar structure, is used to push against the support of valvular prosthetic replacement's device.
Described piped interior sheath is socketed in the afterbody of support fixing head.
When valvular prosthetic replacement's device is loaded on the described conveyer device; Support one end of valvular prosthetic replacement's device is fastened in the locating slot of support fixing head through fixing ear; The other end pushes against the afterbody of seeker; The afterbody of seeker is connected with hauling rope, and hauling rope passes the support of valvular prosthetic replacement's device, the through hole and the interior sheath of support fixing head successively, and the part of sheath just can directly be controlled seeker in the pulling hauling rope passed.And described epitheca with interior sheath, support fixing head and valvular prosthetic replacement's device parcel within it; The termination of epitheca also pushes against the afterbody of seeker; So just can valvular prosthetic replacement's device be wrapped up within it fully, can avoid after the support of valvular prosthetic replacement's device is getting in the human body spreading immediately.
Interior sheath passes epitheca away from an end of seeker; Spur the relative motion that this part just can realize interior sheath and epitheca, when valvular prosthetic replacement's device arrived the precalculated position, the pulling epitheca came out valvular prosthetic replacement's device; The support of valvular prosthetic replacement's device just can be under the body temperature effect spreading in place; This moment, support separated with seeker, and the fixedly ear of support is also deviate from from locating slot, spurs hauling rope, interior sheath and epitheca at last seeker and the fixing first-class parts of support are extracted out.
Turn when advancing for the ease of conveyer device, be provided with bail in the housing that closes on the guiding head end of described epitheca, this bail is in the housing of axis arranged at epitheca of epitheca; Axis along epitheca in the housing of epitheca has passage; This passage one end arrives at bail, the other end along away from the direction of seeker until the end of epitheca housing, described passage is built-in with the epitheca hauling rope; Epitheca hauling rope one end is connected with bail; The other end stretches out the outside that passage extends to epitheca, and the part that pulling is stretched out just can directly affect bail, because bail closes on seeker; It is crooked to make the effect of sheath hauling rope outside of seeker position drive whole conveyer device down, is convenient to control the turning of conveyer device.
For the ease of the turning of conveyer device, described interior sheath, epitheca all adopt elasticity better biocompatibility material to process, and concrete selecting for use of material can be adopted prior art.Described bail generally is placed in the housing of epitheca through preembedded mode.
Described epitheca promptly requires to keep the hot strength of necessity, also will avoid when it is crooked, keeping the unobstructed of inside, has fold resistance.As being distributed with spiral metal wire around the epitheca axis in the tubular shell of preferred described epitheca, when epitheca was crooked, spiral metal wire can support its housing, kept the unobstructed of inside.
Moreover, be distributed with netted fortifying fibre in the tubular shell of described epitheca, can make it keep higher draw tensile strength like this, avoid unnecessary deformation.
Conveyer device of the present invention generally is that epitheca is drawn back certain distance when discharging valvular prosthetic replacement's device, and holder part is exposed in the human body environment, promptly at first is that part discharges; Generally can discharge 1/4～3/4 of stent length earlier, d/d part support spreading under the body temperature effect, the effect in place that like this can observe support according to the situation behind the spreading; Can spur interior sheath if find position words devious, drive the support fixing head then, because the fixedly ear of support does not also discharge at this moment; Still under the parcel of epitheca, be in the locating slot; The support fixing head just can spur fixedly that ear makes support progress into epitheca, and under the extruding of epitheca inwall, support can draw in until being got back to the state before discharging by the epitheca parcel fully gradually; Then reorientate again, discharge; Like this just can the first time support in place when unsuccessful, adjustment in time is until the position that valvular prosthetic replacement's device is released in the best.
The artificial valve replacement device of the present invention is located and can be reclaimed when undesirable, carries out the adjustment of position, difficulty and risk when having reduced operation like this.
When being loaded in valvular prosthetic replacement's device on the described conveyer device; Need the fixedly ear that support pushes up the edge be embedded in the locating slot of support fixing head outer wall, match when the position of locating slot and shape size are with fixing ear certainly, and then the interior sheath of twitch makes epitheca that support is wrapped; Promptly under the parcel of epitheca fixedly ear be limited in the locating slot all the time; If a plurality of fixedly ears are arranged, and when fixedly the height of ear is identical, need simultaneously with all fixedly ears be pressed into simultaneously twitch again behind the locating slot in sheath; In case otherwise certain fixedly ear do not have in place and in twitching during sheath, do not have fixedly ear in place will stop epitheca even the outside of translating into epitheca.Certain degree of difficulty is arranged when therefore loading.
And in the optimized technical scheme of the present invention, the height of a plurality of fixedly ears is different, can at first highly the highest fixedly ear be pressed into locating slot when in place; Sheath wraps the epitheca fixedly ear that this is in place in twitching then, because other fixedly auricular height degree is lower, therefore when epitheca when fixedly ear wraps with first; Can not influence remaining fixedly ear be pressed into corresponding locating slot; Next next fixedly ear of height is pressed into corresponding locating slot, in twitching again sheath make epitheca with second fixedly ear wrap, by highly one by one that all fixedly ear parcels is in place by that analogy; Like this each needs to operate a fixedly ear; Promptly handle one by one and be pressed into locating slot, do not need to be pressed into simultaneously locating slot, reduced the operation easier when loading greatly.
The support that need to prove valvular prosthetic replacement's device is the state that draws in when not using; It is fine and close tubular structure; Generally be that tubing through memory metal material forms through Laser cutting, and get into human body and discharge after can under the body temperature effect, form fluffy tubular structure by spreading, if there is not specified otherwise among the present invention; When describing the structure of valvular prosthetic replacement's device and support thereof, all be meant the structure under the complete spreading state in human body.
The artificial valve replacement device of the present invention does not need surgical operation just can replace the cardiac valve of pathological changes; Process blood vessel during displacement; Generally be to implant heart through femoral artery; And heart and aorta do not need surgical incision, and certain valvular prosthetic replacement's device of the present invention also can be inserted through the mode that between chest rib, spiles with the apex of the heart.
Artificial valve replacement device of the present invention and support have changeover portion; Can play cushioning effect; Can protect valve bracket and inner SANYE valve, long-time use also can guarantee sealing, the artificial valve replacement device of the present invention good positioning effect; Not only reduced the difficulty of operation, also realized recyclable.
Description of drawings
Fig. 1 is the supporting structure sketch map of valvular prosthetic replacement's device in the prior art.
Fig. 2 is the supporting structure sketch map of the artificial valve replacement device of the present invention.
Fig. 3 is the structural representation of the another kind of embodiment of the support of the artificial valve replacement device of the present invention.
Fig. 4 is the structural representation of the third embodiment of the support of the artificial valve replacement device of the present invention.
Fig. 5 discharges preceding expansion sketch map for the support of the artificial valve replacement device of the present invention.
Fig. 6 loads the internal structure sketch map behind valvular prosthetic replacement's device for conveyer device of the present invention.
Fig. 7 loads the preceding internal structure sketch map of valvular prosthetic replacement's device for conveyer device of the present invention.
Fig. 8 is the internal structure sketch map of conveyer device of the present invention when valvular prosthetic replacement's device partly stretches out epitheca.
Fig. 9 is the perspective view of conveyer device medium-height trestle fixing head of the present invention.
Figure 10 is the perspective view of another angle of Fig. 9 medium-height trestle fixing head.
Figure 11 is the sketch map of Figure 10 medium-height trestle fixing head along Z direction among the figure.
Figure 12 is the profile of Figure 11 medium-height trestle fixing head.
Figure 13 is the profile along another section of Figure 11 medium-height trestle fixing head.
Figure 14 is the trisected profile in edge of Figure 11 medium-height trestle fixing head.
Figure 15 is the profile at position, epitheca termination in the conveyer device of the present invention.
Figure 16 is conveyer device of the present invention structural representation when crooked.
Figure 17 is the internal structure sketch map of epitheca in the conveyer device of the present invention.
Figure 18 is the structural representation of the 4th kind of embodiment of the support of the artificial valve replacement device of the present invention.
The specific embodiment
The artificial valve replacement device of the present invention is made up of support and the SANYE valve that is fixed in the support; Referring to Fig. 2; The support netted tubular construction that the aortic stents 4, changeover portion support 5, valve bracket 6 and the efferent tract support 7 that connect constitute of serving as reasons successively; Match with conveyer device when being used in the implant into body along being provided with fixedly ear 60 in aortic stents 4 tops.
The radial strength of changeover portion support 5 is less than the radial strength of valve bracket 6.That is to say the tensile strength of the tensile strength of changeover portion support 5 less than valve bracket 6.Deformation takes place in changeover portion support 5 more easily, only in this way could play buffering and Absorption to the deformation of aortic stents 4, is unlikely to cause the deformation of valve bracket 6, firmness and sealing that protection SANYE valve seam is put.
Visible changeover portion carrier unit lattice are similar with valve bracket cell shape among the figure, and the cell area of changeover portion support is 4: 1 with the ratio of the cell area of valve bracket.This also certainly will cause changeover portion support 5 that deformation takes place more easily.
Referring to Fig. 3, be provided with location thorn 9a and location thorn 9b at the position that valve bracket contacts with heart, location thorn 9a and location thorn 9b stretch out and away from the support axis from the valve bracket outer wall is downward-sloping.Be provided with three location thorns altogether, because 9a and location thorn 9b are stung in rarely seen location among the angle problem figure, the length that the location is stung is 1cm.
The top of support is along having three fixedly ears, because rarely seen fixedly ear 60a and fixing ear 60b among the angle problem figure.Fixedly ear is the T-shape structure, three fixedly the height on the edge, top of ear be inconsistent, visible fixedly ear 60b will be apparently higher than fixing ear 60a among the figure.
Referring to Fig. 4; Inwardly draw in to avoid the stimulation to sinuatrial node the bottom of efferent tract support 6; The height H of the bottom of inwardly drawing in here is 0.5cm, and along arc trajectory, the included angle A of the line of this camber line Origin And Destination and the axis of support was 20 degree when inwardly drew in the bottom; Suitable angle not only can have been avoided the stimulation of sinuatrial node but also can keep the proper supporting direction, guaranteed the unimpeded of blood runner.
Referring to Fig. 5, the support of valvular prosthetic replacement's device is the state that draws in when not using, and is fine and close tubular structure; Be that tubing through memory metal material forms through Laser cutting; Fig. 5 is the expanded view of the support after cutting, visible three height different fixed ears among the figure, and wherein fixedly ear 60c is the highest; Fixedly ear 60b secondly, and fixedly ear 60a is minimum.
Referring to Fig. 6, the present invention is used for valvular prosthetic replacement's device is delivered to the intravital conveyer device of people, comprising:
The support fixing head 105 of band through hole, the outer wall of support fixing head 105 1 ends has the locating slot 107 that matches with the support of valvular prosthetic replacement's device, and the other end is connected with interior sheath 102;
Piped epitheca 101, sheath 102 and support fixing head 105 outsides in being enclosed within.
Establish between visible seeker 103 and the support fixing head 105 among Fig. 7 in addition and be connected with core pipe 106, hauling rope 104 passes in core pipe 106, and core pipe 106 is weaved into by fiber, and it is soft again flexible to have good tensile strength.
Referring to Fig. 9, Figure 10; For engagement height different fixed ear; The length of the locating slot of support fixing head 105 outer walls also has nothing in common with each other, and visible support fixing head 105 has through hole 110 among the figure, is used to pass hauling rope 104; Support fixing head 105 is the tubular structures that are made up of head of somewhat larger in diameter 108 and the smaller afterbody 109 of diameter, wherein in sheath 102 be exactly to be socketed on the afterbody 109 of support fixing head 105.
The length of locating slot described herein is meant along the length of support fixing head 105 axis directions; As being example to adopt support shown in Figure 5; In order to cooperate three height different fixed ears; Support fixing head 105 outer walls have the shortest locating slot 107a of length, middle locating slot 107b of length and the longest locating slot 107c of length.
In Figure 11～Figure 14, can further find out locating slot 107a, the length of locating slot 107b and locating slot 107c has nothing in common with each other.
Visible among Figure 11 in addition, be pressed in the locating slot for the ease of fixing ear, the position that the locating slot opening part promptly matches with the fixing cervical region of ear has chamfering 111, can guide fixedly ear entering locating slot smoothly.
Referring to Figure 15 and Figure 16, turn when advancing for the ease of conveyer device, be provided with bail 120 in the housing that closes on seeker 103 ends of epitheca 101; In the housing of epitheca 101, the axis along epitheca in the housing of epitheca 101 has passage to bail 120 around the axis arranged of epitheca 101, and this passage one end arrives at bail 120; The other end is along away from the direction of seeker 103 end until epitheca 101 housings; Passage is built-in with epitheca hauling rope 121, and epitheca hauling rope 121 1 ends are connected with bail 120, and the other end stretches out the outside that passage extends to epitheca 101; The part that pulling is stretched out just can directly affect bail 120; Because bail 120 closes on seeker 103, it is crooked to make seeker 103 positions under the effect of epitheca hauling rope 121, drive whole conveyer device, is convenient to control the turning of conveyer device.
For the ease of the turning of conveyer device, described in sheath, epitheca all adopt elasticity preferably biocompatible material process, concrete selecting for use of material can be adopted prior art.Described bail generally is placed in the housing of epitheca through preembedded mode.
Referring to Figure 17; Epitheca 101 requires to keep the hot strength of necessity; Also to avoid when it is crooked, keeping the unobstructed of inside, so be distributed with spiral metal wire 122 around epitheca 101 axis in the tubular shell of epitheca 101, when epitheca 101 bendings; Spiral metal wire 122 can support its housing, keeps the unobstructed of inside.Also be distributed with netted fortifying fibre 123 in the tubular shell of epitheca 101, can make it keep higher draw tensile strength and the expansion that can resist support like this, avoid unnecessary deformation.
Referring to Figure 18; In the artificial valve replacement device of the present invention aortic stents 4, the changeover portion support 5; The serpentine lines have more been adopted in the network structure; Like this radial motion and the bending of aortic stents 4, changeover portion support 5 can further be absorbed, and can reduce the influence of valve bracket 6 and efferent tract support 7.
The present invention will at first be loaded on the conveyer device when artificial valve replacement device uses; At first make the support fixing head stretch out epitheca; The fixedly ear that seeker passes behind valvular prosthetic replacement's device the edge, support top of valvular prosthetic replacement's device embeds in the locating slot of support fixing head outer wall, and the position of locating slot and shape are big or small certainly matches during with fixing ear, when the height of a plurality of fixedly ears is different; Can at first highly the highest fixedly ear be pressed into locating slot when in place; Sheath wraps the epitheca fixedly ear that this is in place in twitching then, because other fixedly auricular height degree is lower, therefore when epitheca when fixedly ear wraps with first; Can not influence remaining fixedly ear be pressed into corresponding locating slot; Next next fixedly ear of height is pressed into corresponding locating slot, in twitching again sheath make epitheca with second fixedly ear wrap, by highly one by one that all fixedly ear parcels is in place by that analogy.
Valvular prosthetic replacement's device stretches to heart inside together with valvular prosthetic replacement's device by femoral artery with conveyer device after loading and accomplishing, and can cooperate pulling epitheca hauling rope 121 when needing to turn.
Conveyer device is drawn back certain distance with epitheca after arriving the precalculated position, and valvular prosthetic replacement's device partly is exposed in the human body environment; Promptly at first be that part discharges, generally can discharge 1/2 of stent length earlier, d/d part support spreading under the body temperature effect; Like this can observe the effect in place of support, can spur interior sheath, drive the support fixing head then if find position words devious according to the situation behind the spreading; Because this moment, the fixedly ear of support did not also discharge, still under the parcel of epitheca, be in the locating slot, the support fixing head just can spur fixedly that ear makes support progress into epitheca; Under the extruding of epitheca inwall; Support can draw in until being got back to the state before discharging by the epitheca parcel fully gradually, then reorientates again, discharges, until valvular prosthetic replacement's device being released in best position.
The artificial valve replacement device of the present invention does not need surgical operation just can replace the cardiac valve of pathological changes; Process blood vessel during displacement; Generally be to implant heart through femoral artery; And heart and aorta do not need surgical incision, and certain valvular prosthetic replacement's device of the present invention also can be inserted through the mode that between chest rib, spiles with the apex of the heart.
Claims (10)
1. support that has valvular prosthetic replacement's device of cushioning effect; Comprise aortic stents, valve bracket and efferent tract support; It is characterized in that, be provided with the changeover portion support, the netted tubular construction that described aortic stents, changeover portion support, valve bracket and efferent tract support connect and compose successively; The top of described aortic stents is along being provided with at least two fixedly ears, and fixedly the height on the edge, top of ear is different between two for each.
2. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 1 is characterized in that the radial strength of described changeover portion support is less than the radial strength of valve bracket.
3. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 1; It is characterized in that; Described changeover portion support has the similar cell of shape with valve bracket, and the cell area of changeover portion support is 3～6: 1 with the ratio of the cell area of valve bracket.
4. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 3 is characterized in that, the cell area of changeover portion support is 3～4: 1 with the ratio of the cell area of valve bracket.
5. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 1 is characterized in that, described fixedly ear is made up of head and the cervical region that is used for this head is connected edge, aortic stents top.
6. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 5 is characterized in that, described fixedly ear is the T-shape structure or " L " type of falling.
7. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 1 is characterized in that, inwardly draw in or the outer wall of this bottom and the parallel axes of support the bottom of described efferent tract support.
8. like each described support that has valvular prosthetic replacement's device of cushioning effect of claim 1～7; It is characterized in that; Be provided with the location thorn at the position that described valve bracket or efferent tract support contact with heart, this location is stung from the outer wall of valve bracket or efferent tract support is downward-sloping and is stretched out and away from the support axis.
9. the support that has valvular prosthetic replacement's device of cushioning effect as claimed in claim 8 is characterized in that, the length of described location thorn is 0.3～1.5cm.
10. valvular prosthetic replacement's device; It is characterized in that, by constituting like the support of each described valvular prosthetic replacement's device that has a cushioning effect of claim 1～9 and SANYE valve in the support that is fixed on the valvular prosthetic replacement's device that has cushioning effect.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101507617A CN101961273B (en) | 2010-04-19 | 2010-04-19 | Valvular prosthetic replacement device with buffer action and stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101507617A CN101961273B (en) | 2010-04-19 | 2010-04-19 | Valvular prosthetic replacement device with buffer action and stent |
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| Publication Number | Publication Date |
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| CN101961273A CN101961273A (en) | 2011-02-02 |
| CN101961273B true CN101961273B (en) | 2012-11-21 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2010101507617A Active CN101961273B (en) | 2010-04-19 | 2010-04-19 | Valvular prosthetic replacement device with buffer action and stent |
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| CN (1) | CN101961273B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2017196912A1 (en) * | 2016-05-13 | 2017-11-16 | St. Jude Medical, Cardiology Division, Inc. | Heart valve with stent having varying cell densities |
| US11819403B2 (en) | 2016-02-05 | 2023-11-21 | Edwards Lifesciences Corporation | Devices and systems for docking a heart valve |
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| CN103330605B (en) * | 2013-03-15 | 2016-01-20 | 杭州启明医疗器械有限公司 | A kind of sheath core and comprise the intervention apparatus conveying system of this sheath core |
| CN103431926B (en) * | 2013-09-04 | 2015-09-30 | 杭州启明医疗器械有限公司 | For intervention apparatus conveying sheath core and there is the induction system of this sheath core |
| CN104546224A (en) * | 2014-06-17 | 2015-04-29 | 赛诺医疗科学技术有限公司 | Stent type heart valves and stent thereof |
| CN107252363B (en) * | 2015-03-26 | 2020-04-28 | 杭州启明医疗器械股份有限公司 | Valve stent with reduced compressed length and valve replacement device with same |
| US10653523B2 (en) | 2017-01-19 | 2020-05-19 | 4C Medical Technologies, Inc. | Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves |
| US10561495B2 (en) | 2017-01-24 | 2020-02-18 | 4C Medical Technologies, Inc. | Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve |
| USD867595S1 (en) | 2017-02-01 | 2019-11-19 | Edwards Lifesciences Corporation | Stent |
| CN109498213A (en) | 2017-09-14 | 2019-03-22 | 上海微创心通医疗科技有限公司 | A kind of valve bracket and valve prosthesis |
| US11857441B2 (en) | 2018-09-04 | 2024-01-02 | 4C Medical Technologies, Inc. | Stent loading device |
| US11931253B2 (en) | 2020-01-31 | 2024-03-19 | 4C Medical Technologies, Inc. | Prosthetic heart valve delivery system: ball-slide attachment |
| US11992403B2 (en) | 2020-03-06 | 2024-05-28 | 4C Medical Technologies, Inc. | Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells |
| CN111772882B (en) * | 2020-08-17 | 2021-07-13 | 四川大学 | Pulmonary artery support and pulmonary valve replacement device convenient to control |
| CN114073603B (en) * | 2020-08-20 | 2023-05-02 | 先健科技(深圳)有限公司 | Valve support and artificial heart valve |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8062359B2 (en) * | 2005-04-06 | 2011-11-22 | Edwards Lifesciences Corporation | Highly flexible heart valve connecting band |
| EP2901967B1 (en) * | 2005-05-24 | 2019-10-02 | Edwards Lifesciences Corporation | Rapid deployment prosthetic heart valve |
| US9572660B2 (en) * | 2007-06-04 | 2017-02-21 | St. Jude Medical, Inc. | Prosthetic heart valves |
| US8747458B2 (en) * | 2007-08-20 | 2014-06-10 | Medtronic Ventor Technologies Ltd. | Stent loading tool and method for use thereof |
| CN101352376A (en) * | 2008-09-02 | 2009-01-28 | 中国人民解放军第二军医大学 | Aorta valve stent with anchoring foot |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11819403B2 (en) | 2016-02-05 | 2023-11-21 | Edwards Lifesciences Corporation | Devices and systems for docking a heart valve |
| WO2017196912A1 (en) * | 2016-05-13 | 2017-11-16 | St. Jude Medical, Cardiology Division, Inc. | Heart valve with stent having varying cell densities |
| US10321994B2 (en) | 2016-05-13 | 2019-06-18 | St. Jude Medical, Cardiology Division, Inc. | Heart valve with stent having varying cell densities |
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|---|---|
| CN101961273A (en) | 2011-02-02 |
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Address after: 310051 311, 3 building, 2 building, 88 Jiangling Road, Binjiang District, Hangzhou, Zhejiang. Patentee after: Hangzhou Qiming Medical Devices Co., Ltd. Address before: 310000 East Building of Tax Youyou Building, 3738 Nanhuan Road, Binjiang District, Hangzhou City, Zhejiang Province Patentee before: Hangzhou Qiming Medical Device Co., Ltd. |