CN108125732A - Artificial valve and prosthetic valve apparatus - Google Patents
Artificial valve and prosthetic valve apparatus Download PDFInfo
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- CN108125732A CN108125732A CN201810116225.1A CN201810116225A CN108125732A CN 108125732 A CN108125732 A CN 108125732A CN 201810116225 A CN201810116225 A CN 201810116225A CN 108125732 A CN108125732 A CN 108125732A
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- diaphragm seal
- leaflet
- valve
- suture
- artificial valve
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- 230000003014 reinforcing effect Effects 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 3
- 239000004744 fabric Substances 0.000 claims description 2
- 201000010298 pulmonary valve insufficiency Diseases 0.000 abstract description 7
- 238000010586 diagram Methods 0.000 description 14
- 210000003102 pulmonary valve Anatomy 0.000 description 10
- 210000001147 pulmonary artery Anatomy 0.000 description 8
- 239000008280 blood Substances 0.000 description 7
- 210000004369 blood Anatomy 0.000 description 7
- 230000003902 lesion Effects 0.000 description 6
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- 208000032170 Congenital Abnormalities Diseases 0.000 description 5
- 238000010992 reflux Methods 0.000 description 5
- 230000002861 ventricular Effects 0.000 description 5
- 208000002330 Congenital Heart Defects Diseases 0.000 description 4
- 206010010356 Congenital anomaly Diseases 0.000 description 4
- 208000028831 congenital heart disease Diseases 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 210000002216 heart Anatomy 0.000 description 4
- 208000023281 Fallot tetralogy Diseases 0.000 description 3
- 206010061876 Obstruction Diseases 0.000 description 3
- 201000003005 Tetralogy of Fallot Diseases 0.000 description 3
- 210000001367 artery Anatomy 0.000 description 3
- 238000006073 displacement reaction Methods 0.000 description 3
- 210000003709 heart valve Anatomy 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 208000009138 pulmonary valve stenosis Diseases 0.000 description 3
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- 238000001356 surgical procedure Methods 0.000 description 3
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- 210000000709 aorta Anatomy 0.000 description 2
- 239000002473 artificial blood Substances 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 230000001413 cellular effect Effects 0.000 description 2
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- 230000001225 therapeutic effect Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 208000004375 Angiodysplasia Diseases 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
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- 208000029767 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diseases 0.000 description 1
- 208000029497 Elastoma Diseases 0.000 description 1
- 208000001826 Marfan syndrome Diseases 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
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Classifications
-
- 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
-
- 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
- A61F2/2415—Manufacturing methods
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic 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)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a kind of artificial valve and prosthetic valve apparatus, the artificial valve includes diaphragm seal and leaflet, the diaphragm seal is cylindrical in shape, the both ends of the diaphragm seal are respectively provided with outside one and are flared, it is tooth-shape structure at the port of the outer flaring, the middle part of the diaphragm seal is in straight-tube shape, the internal diameter of the outer flaring is more than the internal diameter in the middle part of the diaphragm seal, the diaphragm seal is sutured by least three sealing film units, the loop configuration that the leaflet is connected into for the suture of at least three leaflet units, the leaflet are set on the middle part of the diaphragm seal.The prosthetic valve apparatus includes above-mentioned artificial valve and valve frame.Its purpose is to provide a kind of artificial valve for improving pulmonary regurgitation and prosthetic valve apparatus, the safety used and validity are improved.
Description
Technical field
The present invention relates to the heart valve technologies of medical instruments field, belong to intervention therapeutic apparatus field, more particularly to one
Kind artificial valve and prosthetic valve apparatus.
Background technology
Congenital heart disease is that fetal period heart and congenital cardiovascular system caused by angiodysplasia are abnormal
Shape is children's period most common heart disease.According to statistics, in every 1000 newborns, 6~7 have Congenital malformation of heart.According to
Demographer estimates that China's about 1 million people suffers from congenital heart disease, about increases 200,000 children with CHD, wherein complexity newly every year
Congenital heart disease accounts for about 20%.Many complex congenital heart lesions seriously involve right ventricular outflow, and after surgery efferent tract Reconstruction
Pulmonary regurgitation or restenosis often occurs, needs to rebuild right ventricular outflow again.
It can not only be corrected through conduit cusps of pulmonary valve displacement technique narrow, can also handle valvular regurgitation, the technology is quiet through periphery
Arteries and veins approach will manually band valve bracket be placed at Pulmonary autograft by conduit, instead of having lost the cusps of pulmonary valve of function,
To reach therapeutic purposes.
The reason of pulmonary regurgitaion, is as follows：1. congenital pulmonary is completely lopsided：Can be complete missing, unilobar lung artery
Valve and other deformities, are common in patients with tetralogy of Fallot.2. Marfan syndrome：Lesion mainly involves aorta petal and bicuspid valve,
But have been reported that about 26.9% patient's lesion involves pulmonary valve and has pulmonary regurgitation.3. cardiac tumor：Mamillary is fine
It is in close relations to tie up Elastoma and pulmonary valve lesion, it is seen that tumour is in multiple leaflets and passes through the leaf base of a fruit and be attached to the internal membrane of heart.
Generally it is common in aorta petal or pulmonary valve ventricular side.Adhere to gross tumor volume increase, middle severe pulmonary valve may be caused anti-
Stream, not companion or companion's pulmonary stenosis.4. pulmonary valve annulus is expanded：As long-term pulmonary hypertension can lead to pulmonary artery and annulus
Expansion, so as to cause pulmonary regurgitation.Right ventricular outflow (RVOT) is narrow, obstruction patient, may occur in which post-stenotic dilatation and
Expand annulus, so as to cause pulmonary regurgitaion.It is 5. iatrogenic：It is clinically most clinical meaning, most common factor at present,
It is also the current main suitable crowd of percutaneous pulmonary valve implantation (PPVI).At home, tetralogy of Fallot etc. has pulmonary artery
During the narrow patient's row operative correction of valve generally across the valve sticking patch arts of row RVOT (RVOT, pulmonary artery it is longitudinally slit after again plus mend
Piece is to expand official jargon internal diameter) to release pulmonary stenosis, but pulmonary valve annulus can be caused to expand, leaflet Poor fitness is led
Apparent pulmonary artery is caused to shunt；And external many Heart centers then can be placed in band valve artificial blood vessel in ROVT, although in a short time
Pulmonary regurgitaion is not had, but after prolonged application, artificial blood vessel will appear calcification and lead to outflow obstruction, and its biovalve
It will appear functional deterioration and lead to valvular inadequacy or narrow, this kind of crowd is that current PPVI mainly applies crowd.
In October, 2000, the team of Bonhoeffer report it is the first be applied to clinical PPVI, they to one 12 years old
There are patient's successful implementation of pulmonary stenosis merging reflux PPVI operations after receiving tetralogy of Fallot prosthetic.Then,
The technology is used for more patients.2005, Bonhoeffer reported the lung to 100 16-35 Sui in the TCT session
The situation of congenital disorders patient's row PPTV such as arterial valve incompetence or RVOT obstructions, follow-up 0.5-5 is without death, the postoperative right side
Ventricular pressure is decreased obviously, and exercise tolerance significantly improves.
It is relative to the advantages of surgery open chest surgery percutaneous pulmonary valved prosthesis art：(1) long-term anti-freezing is not needed to；(2)
Close to normal Hemodynamics after displacement；(3) chronic tissue can be maintained upper and the integrality of function；(4) wound is small, injures
Gently.
In percutaneous heart valve displacement technique there are two types of common heart valve prosthesises：A kind of is Medtronic companies
Melody balloon expandables intervene valve.Melody devices is are sewed with cloverleaf ox on platinum-iridium balloon-expandable alloy bracket
Jugular vein valve.The internal diameter variation range that valve is implanted into during expansion is larger, is 10~22mm, this is attributed to the fact that the made leaflet of venous valve
Favorable elasticity and larger leaflet faying face.Stock size is 18~22mm.Another kind is the SAPIEN balls of Edwards companies
Capsule expansion intervention valve.The stent of SAPIEN valves uses stainless steel as material, and uses durable bovine pericardium as leaflet material
Expect, while seal cuff also to become the generation that higher has reduced perivalvular leakage.The valve has the models such as 23mm, 26mm at present.They
Structure be all straight barrel type, the pulmonary valve ring diameter used is in 16~22mm, and pulmonary artery annulus is expanded for this and main lung moves
The patient of arteries and veins deformity is not appropriate for.
Invention content
The technical problem to be solved in the present invention is to provide a kind of artificial valves and artificial valve for improving pulmonary regurgitation
Device improves the safety used and validity.
Artificial valve in the present invention, including diaphragm seal and leaflet, the diaphragm seal is cylindrical in shape, the both ends of the diaphragm seal
It is respectively provided with outside one and is flared, be tooth-shape structure at the port of the outer flaring, the middle part of the diaphragm seal is described outer in straight-tube shape
The internal diameter of flaring is more than the internal diameter in the middle part of the diaphragm seal, and the diaphragm seal is sutured by least three sealing film units, institute
The loop configuration that leaflet is connected into for the suture of at least three leaflet units is stated, the leaflet is set on the middle part of the diaphragm seal.
Artificial valve in the present invention, wherein the upper and lower ends of the diaphragm seal unit are obliquely installed outward respectively, institute
The upper and lower ends for stating sealing film unit are respectively equipped with reinforcing ear, and the ear of reinforcing forms the outer tooth form knot being flared at port
Structure, the middle part of the sealing film unit is rectangle, and the both sides of the sealing film unit are joining edge, and the joining edge is wide by 0.5
The groove-like side of~3 ㎜.
Artificial valve in the present invention, wherein the leaflet unit includes the upper rectangle being integrally formed and lower rectangle, it is described
Upper rectangle is connected with the lower rectangle by respective long side, and the long edge lengths of the upper rectangle are more than the length of the lower rectangle
Edge lengths, two angles far from the upper rectangle of the lower rectangle remove and rounded corner, at two short sides of the upper rectangle
To suture ear, the edge of the lower rectangle is fixed edge, and the width of the fixed edge is 0.5~3 ㎜.
Artificial valve in the present invention, wherein the leaflet unit of the leaflet is on the circumferencial direction in the middle part of the diaphragm seal
It is evenly arranged.
Artificial valve in the present invention, wherein the suture way of two neighboring sealing film unit joining edge is spiral suture side
The formula rack suture way that either two sides alternately passes through or matrix suture way or right-angled intersection suture way.
Artificial valve in the present invention, wherein what the suture way of two neighboring sealing film unit joining edge knotted for lasso
The distance between mode, two neighboring knotting node is 1~4 ㎜.
Artificial valve in the present invention, wherein suture way of the leaflet on diaphragm seal is along leaflet unit fixed edge
The rack suture way alternately passed through between diaphragm seal and leaflet two sides either spiral suture way or matrix suture way or
Person's zigzag suture way.
Artificial valve in the present invention, wherein suture way of the leaflet on diaphragm seal is close along leaflet fixed edge
Being alternately passed through between sealer and leaflet two sides makes each node T-shaped, and the distance between two neighboring node is 1~4 ㎜.
Prosthetic valve apparatus in the present invention, including artificial valve and valve frame, the valve frame is both ends in lotus shape, centre
In the network of straight-tube shape, the valve frame is followed successively by upper, middle and lower from top to bottom, and the upper and lower part is in described
Lotus shape, the middle part are in the straight-tube shape, and each portion is connected with each other by multiple rhomboids, and the artificial valve is upper
The artificial valve stated, the outer flaring at the diaphragm seal both ends matches respectively with the valve frame in the both ends of lotus shape, described close
Match in the middle part of the middle part of sealer and the valve frame, the diaphragm seal is sutured on the inner wall of the valve frame.
Prosthetic valve apparatus in the present invention, wherein between the top and middle part of the valve frame and between middle part and lower part
It is connected by rigid montant, connects rigid montant being arranged circumferentially along valve frame at top and middle part, connection middle part is under
The rigid montant in portion is arranged in correspondingly between the rhomboid at middle part and the rhomboid of lower part, the both ends point of the diaphragm seal
It is not sewn to the both ends of the valve frame correspondingly in a manner of package, suture way of the artificial valve on valve frame is
Upper and lower end parts are the mode that lasso knots, remaining position is the bar along the composition rhomboid of valve frame with stepped semi-circular
Mode around rod sutures, and the distance of two neighboring semi-ring is 1~5 ㎜.
Artificial valve difference from prior art in the present invention is：Leaflet is sewn to both ends by the artificial valve
In the inside of the diaphragm seal of bowl-mouth shape, and the peak of leaflet is less than the upper edge of diaphragm seal so that leaflet is completely wrapped
Be rolled among diaphragm seal, when leaflet is closed, the blood of artificial valve upper end reflux be completely limited in diaphragm seal and
In the space that the leaflet of closed state is formed, improve pulmonary regurgitation, the outside lotus shape structure at both ends is (i.e. in tooth form
The outer flaring of structure) can be suitable for pulmonary artery expand or deformity lesion.The leaflet constructor interflow body of the artificial valve
Dynamical structure, and the suture of artificial valve is solid and reliable, improves safety in utilization and validity.
In order to improve the deficiencies in the prior art, the present invention also provides a kind of simple in structure, it be attached to artificial valve and suture
Securely, the prosthetic valve apparatus of blood reflux can be reduced.
The invention will be further described below in conjunction with the accompanying drawings.
Description of the drawings
Fig. 1 is the diaphragm seal cellular construction schematic diagram in the present invention；
Fig. 2 is the seal diaphragm structure schematic diagram in the present invention；
Fig. 3 is the leaflet cellular construction schematic diagram in the present invention；
Fig. 4 is the leaflet structure diagram in the present invention；
Fig. 5 is the prosthetic valve structures schematic diagram in the present invention；
Fig. 6 is prosthetic valve apparatus's structure diagram in the present invention；
Fig. 7 is the lasso knotting suture way schematic diagram in the present invention；
Fig. 8 is that the spiral in the present invention sutures schematic diagram；
Fig. 9 is the rack-shaped suture way schematic diagram in the present invention；
Figure 10 is the matrix suture way schematic diagram in the present invention；
Figure 11 is the right-angled intersection suture way schematic diagram in the present invention；
Figure 12 is that the zigzag in the present invention sutures schematic diagram；
Figure 13 is the T shape suture way schematic diagrames in the present invention；
Figure 14 is the stepped semi-circular suture way schematic diagram in the present invention.
Wherein, each reference numeral in figure：
100- seals film unit, and 101- seals the joining edge of film unit, and 102- seals the reinforcing ear of film unit, 103- and branch
The matching sideline of frame, 110- diaphragm seals, 111- diaphragm seals upper edge, 112- diaphragm seals lower edge, 113- diaphragm seal splicing lines,
In the middle part of 114- diaphragm seals and the boundary line at both ends, 200- leaflet units, 201- suture ear, 202- leaflet unit fixed edges, 203-
Leaflet unit dissociates side, 210- leaflets, 211- suture ear splice sections, 212- leaflet fixed edges, 300- artificial valves, 301- leaflets
Suture path in diaphragm seal, 400- prosthetic valve apparatus, 500- valve framves.
Specific embodiment
As shown in figure 5, and with reference to shown in Fig. 1-4, the artificial valve in the present invention, including diaphragm seal 110 and leaflet 210,
The diaphragm seal 110 is cylindrical in shape, and the both ends of the diaphragm seal 110, which are respectively provided with outside one, to be flared, and is at the port of the outer flaring
Tooth-shape structure, it can be seen that, in lotus shape, the middle part of the diaphragm seal 110 is in straight-tube shape, described at the both ends of diaphragm seal 110
The internal diameter of outer flaring is more than the internal diameter at 110 middle part of diaphragm seal, and the diaphragm seal 110 is by least three sealing film units 100
It sutures, the loop configuration that the leaflet 210 is connected into for the suture of at least three leaflet units 200, the leaflet 210 is set on
The middle part of the diaphragm seal 110.
As shown in Fig. 2, the artificial valve in the present invention, wherein the upper and lower ends difference of the diaphragm seal unit 100 is outside
Side is obliquely installed, and the upper and lower ends of the sealing film unit 100, which are respectively equipped with, reinforces ear 102, and the reinforcing ear 102 forms described
Tooth-shape structure at outer flaring port, it can be seen that, sealing film unit 100 crown-shaped outside for both ends, the diaphragm seal list
The middle part of member 100 is rectangle, and the both sides of the sealing film unit 100 are joining edge 101, and the joining edge 101 is wide by 0.5~3
The groove-like side of ㎜.
As shown in figure 3, the artificial valve in the present invention, wherein the leaflet unit 200 includes the upper rectangle being integrally formed
With lower rectangle, the upper rectangle is connected with the lower rectangle by respective long side, and the long edge lengths of the upper rectangle are more than
The long edge lengths of the lower rectangle, two angles far from the upper rectangle of the lower rectangle remove and rounded corner, the upper square
It is suture ear 201 at two short sides of shape, the edge of the lower rectangle is fixed edge 202, and the width of the fixed edge 202 is
0.5~3 ㎜.
Artificial valve in the present invention, wherein the leaflet unit 200 of the leaflet 210 is at 110 middle part of diaphragm seal
It is evenly arranged on circumferencial direction.
As illustrated in figs. 8-11, the artificial valve in the present invention, wherein the suture of two neighboring sealing film unit joining edge 101
Mode is the spiral suture way rack suture way that either two sides alternately passes through or matrix suture way or right-angled intersection
Suture way.
As shown in fig. 7, the artificial valve in the present invention, wherein the suture side of two neighboring sealing film unit joining edge 101
Formula is that the distance between the mode that lasso knots, two neighboring knotting node is 1~4 ㎜.
As shown in Fig. 8,9,10,12, the artificial valve in the present invention, wherein seam of the leaflet 210 on diaphragm seal 110
Conjunction mode be the rack suture way that is alternately passed through between 210 two sides of diaphragm seal 110 and leaflet along leaflet unit fixed edge 202 or
Person's spiral suture way either matrix suture way or zigzag suture way.
As shown in figure 13, the artificial valve in the present invention, wherein suture way of the leaflet 210 on diaphragm seal 110
Make each node T-shaped to be alternately passed through between 210 two sides of diaphragm seal 110 and leaflet along leaflet fixed edge 202, it is two neighboring
The distance between node is 1~4 ㎜, and above-mentioned suture way is T shape suture ways.
As shown in fig. 6, the prosthetic valve apparatus 400 in the present invention, including artificial valve 300 and valve frame 500, the valve frame
500 for both ends in lotus shape, it is intermediate be in straight-tube shape network, the valve frame 500 be followed successively by from top to bottom top, middle part and
Lower part, the upper and lower part are in the lotus shape, and the middle part is in the straight-tube shape, and each portion is mutual by multiple rhomboids
Be formed by connecting, the artificial valve 300 is above-mentioned artificial valve, the outer flaring at 110 both ends of diaphragm seal respectively with it is described
Valve frame 500 matches in the both ends of lotus shape, and the middle part of the diaphragm seal 110 and the middle part of the valve frame 500 match, described
Diaphragm seal 110 is sutured on the inner wall of the valve frame 500.
Prosthetic valve apparatus 400 in the present invention, wherein between the top and middle part of the valve frame 500 and middle part is under
It is connected between portion by rigid montant, connects rigid montant being arranged circumferentially along valve frame 500 at top and middle part, connection
The rigid montant of middle part and lower part is arranged in correspondingly between the rhomboid at middle part and the rhomboid of lower part, as shown in fig. 6,
That is, it is connected between the corresponding rhomboid in middle part and lower part by a rigid montant, the both ends of the diaphragm seal 110
It is sewn to the both ends of the valve frame 500 correspondingly in a manner of package respectively, the artificial valve 300 is on valve frame 500
Suture way be upper and lower end parts be lasso knot mode (as shown in Figure 7), remaining position is the composition institute along valve frame 500
Bar around rod suture (as shown in figure 14) in a manner of stepped semi-circular of rhomboid is stated, the distance of two neighboring semi-ring is 1~5
㎜。
Leaflet 210 is sewn to inside of the both ends in the diaphragm seal 110 of bowl-mouth shape by the artificial valve 300 in the present invention, and
And the peak of leaflet 210 be less than diaphragm seal 110 upper edge so that leaflet 210 be completely wrapped in diaphragm seal 110 it
In, when leaflet 210 is closed, the blood of 300 upper end of artificial valve reflux has completely been limited in diaphragm seal 110 and has been closed
In the space that the leaflet 210 of state is formed, improve pulmonary regurgitation, the outside lotus shape structure at both ends is (i.e. in tooth form
The outer flaring of structure) can be suitable for pulmonary artery expand or deformity lesion.The leaflet constructor interflow body of the artificial valve
Dynamical structure, and the suture of artificial valve is solid and reliable, improves safety in utilization and validity.
As shown in fig. 6, in order to improve the deficiencies in the prior art, the present invention also provides a kind of simple in structure, it is attached to people
The suture of work valve is secured, can reduce the prosthetic valve apparatus 400 of blood reflux.
Diaphragm seal 110 in the present embodiment is to be sutured to form two-by-two by the joining edge 101 on 3 sealing film units, valve
Leaf 210 is formed by connecting by the suture of 3 leaflet units 200, seals the joining edge 101 of film unit from the upper end of sealing film unit 100
The lower end of sealing film unit 100 is through to, the middle part straight-tube shape of diaphragm seal 110 is equipped with leaflet 210, and leaflet 210 is by leaflet list
Suture ear 201 in member 200 sutures the loop configuration connected into two-by-two, and suture path of the leaflet 210 on diaphragm seal 110 is valve
The fixed edge 202 of leaf unit, circumferencial direction of the suture ear 201 at the middle part of diaphragm seal 110 after leaflet unit 200 is connected are equal
Cloth.Diaphragm seal 110 and the suture ear 201 of leaflet 210 are fixed on both ends in the valve frame 500 among lotus shape being in straight-tube shape
On, valve frame 500 is network；Valve frame 500 is made of from top to bottom three parts, and each part is mutual by several rhomboids
It is formed by connecting.Artificial valve 300 is sewn on matched valve frame 500, forms prosthetic valve apparatus 400.
Several footings (i.e. above-mentioned reinforcing ear 102), reinforcing portion parting is distributed in 100 both ends of the sealing film unit
Together in corresponding 500 both ends of valve frame.
The leaflet unit 200 is flowerpot shape.The fixed edge 202 is from 201 edge of suture ear of 200 one end of leaflet unit
The crescent side that the suture ear 201 of lower end curve to the other end is formed, 0.5~3 ㎜ of fixed hem width.
The leaflet unit 200 of the leaflet is uniformly distributed on the circumferencial direction of 110 middle part straight-tube shape of diaphragm seal.
The suture way of two sealing film unit joining edges 101 is the mode or spiral suture way or two sides that lasso knots
The rack suture way or matrix suture way or right-angled intersection suture way alternately passed through.
Preferably, the suture way of the two sealing film units joining edge 101 is the mode that lasso knots, two neighboring to beat
The distance of nodal point is 1~4mm.
Suture way of the leaflet 210 on diaphragm seal 110 be along leaflet unit fixed edge 202 diaphragm seal 110 with
The rack suture way or spiral suture way that are alternately passed through between 210 two sides of leaflet or along fixed edge matrix suture way or sawtooth
Shape suture way or T shape suture ways.
Preferably, suture way of the leaflet 210 on diaphragm seal 110 is in diaphragm seal 110 along leaflet fixed edge 212
Being alternately passed through between 210 two sides of leaflet makes each node T-shaped, and the distance of two neighboring node is 1~4 ㎜.
The upper and lower part of the valve frame 500 is in outside lotus shape, and the middle part of the valve frame 500 is in a tubular form.
Three parts of the valve frame 500 are connected by rigid montant, wherein the connection at the top and the middle part is non-
One-to-one uniform distribution type connection, that is, connect rigid montant being arranged circumferentially along valve frame 500 at top and middle part, middle part with
The connection of lower part is one-to-one full connection, i.e. connection middle part and the rigid montant of lower part is arranged in middle part correspondingly
Between rhomboid and the rhomboid of lower part, as shown in Figure 6, that is to say, that logical between the corresponding rhomboid in middle part and lower part
A rigid montant connection is crossed, this structure helps to improve compliance of the valve frame 500 in releasing position.
The lotus shape at 110 both ends of diaphragm seal and the lotus shape of 500 upper and lower part of valve frame match, and close
110 both ends of sealer are sewn in a manner of wrapping up on valve frame 500 correspondingly.
Suture way of the artificial valve 300 on valve frame 500 for upper and lower end parts be lasso knot mode, remaining position
The around rod suture in a manner of stepped semi-circular along all bars of valve frame 500 is set to, the distance of two neighboring semi-ring is 1~5 ㎜.
The invention will be further described below in conjunction with the accompanying drawings.The invention mainly relates to a kind of artificial valve, both ends are only
Special lotus shape structure causes the present invention that can preferably be applied to pulmonary artery and expand or the patient of deformity.The upper end of artificial valve is
Its blood efferent tract, lower end are that its blood stream is taken part in Taoism.
The first embodiment：As shown in Figs. 1-2, the diaphragm seal 110 in the present embodiment is led to by three pieces sealing film unit 100
The joining edge 101 crossed to each other splices two-by-two to be sutured, due to the crown-shaped structure at sealing film unit both ends so that after suture
Entire diaphragm seal shows the lotus shape at both ends and intermediate straight structure, and forms splicing line 113.Joining edge 101 is
The groove-like structure to concave, diaphragm seal lower edges 111,112 are tooth-shape structure.114 be diaphragm seal straight-tube shape section and lotus flower
The boundary line of shape section is equipped with leaflet 210 between two boundary lines 114.Footing on sealing film unit 100 reinforces ear
102 be to be designed to increase intensity when diaphragm seal is sewn on valve frame with stability, and be designed with the matching sideline with valve frame
103。
The mode for being sewed with lasso knotting or spiral suture way or two sides at joining edge between sealing film unit are handed over
For across rack suture way or matrix suture way or right-angled intersection suture way, as shown in figs. 7-14.What lasso knotted
Suture way is to thread a needle a little to make a call to a slip-knot and be held together two joining edges at each using a suture, and this mode makes
The connection that must be sealed between film unit is more firm.Spiral suture way is that a piece suture is passed through two from same direction always
Joining edge, path substantially one are spiral-shaped.The rack suture way that two sides alternately passes through is suture successively from two sutures
The exposure on side passes through.Matrix suture way is formed by rack suture way round trip.Right-angled intersection suture way is spiral shell
Rotation suture way round trip is formed.Each of more than suture way is threaded a needle a little along the distance of joining edge in 1~4mm
It is interior.
As in Figure 3-5, the leaflet 210 being located between diaphragm seal boundary line 114 is to pass through it by three pieces leaflet unit 200
On suture ear 201 suture be formed by connecting two-by-two, form three suture ear splice sections 211, and the fixed edge of three leaflet units
It has been spliced to form leaflet fixed edge 212.Wherein suture ear splice sections 211 and leaflet fixed edge 212 are leaflet 210 in diaphragm seal
Control of the artificial valve to blood flow direction can be realized by the free side 203 of each leaflet unit in suture path 301 in 110.
The suture way in suture path 301 has the rack suture way alternately passed through between two sides or spiral suture way or along fixed edge square
Battle array suture way or zigzag suture way or T shape suture ways, as shown in figs. 7-14.The rack suture alternately passed through between two sides
It is mode, spiral suture way, identical with the suture way of diaphragm seal along fixed edge matrix suture way.Zigzag suture way is
Developed by matrix suture way, i.e., deviated rotating the needle point alternatively up and down.T shape suture ways are to use a suture
It alternately passes through and is formed between two sides.
As shown in figure 5, the leaflet 210 being sewn in diaphragm seal 110 and diaphragm seal upper end (the i.e. blood stream outlet of artificial valve
End) a good space of sealing performance is formd, it can effectively reduce perivalvular leakage and backflow.
Second of embodiment：As shown in fig. 6, artificial valve 300 is mounted on by the present embodiment has shape memory effect energy
Prosthetic valve apparatus 400 is made in the valve frame 500 voluntarily expanded, suture way of the artificial valve on valve frame is for upper and lower end parts
The mode that lasso knots, for all bars along stent, the around rod in a manner of stepped semi-circular is sutured (such as Figure 14 institutes for remaining position
Show), the distance of two neighboring semi-ring is 1~5 ㎜.Each bar of valve frame is stitched together with the diaphragm seal of artificial valve.
Artificial valve in the present embodiment is using the artificial valve in embodiment one.
Embodiment described above is only that the preferred embodiment of the present invention is described, not to the model of the present invention
It encloses and is defined, under the premise of design spirit of the present invention is not departed from, those of ordinary skill in the art are to the technical side of the present invention
The various modifications and improvement that case is made should all be fallen into the protection domain that claims of the present invention determines.
Claims (10)
1. a kind of artificial valve, it is characterised in that：Including diaphragm seal and leaflet, the diaphragm seal is cylindrical in shape, the diaphragm seal
Both ends are respectively provided with outside one and are flared, and are tooth-shape structure at the port of the outer flaring, and the middle part of the diaphragm seal is in straight-tube shape, institute
State outer flaring internal diameter be more than the diaphragm seal in the middle part of internal diameter, the diaphragm seal by least three sealing film units suture and
Into the loop configuration that the leaflet is connected into for the suture of at least three leaflet units, the leaflet is set in the diaphragm seal
Portion.
2. artificial valve according to claim 1, it is characterised in that：The upper and lower ends difference of the sealing film unit is outside
Side is obliquely installed, and the upper and lower ends of the sealing film unit are respectively equipped with reinforcing ear, and the reinforcing ear forms the outer flared end
The tooth-shape structure at mouthful place, rectangle is in the middle part of the sealing film unit, and the both sides of the sealing film unit are joining edge, the seam
It closes in the groove-like for wide 0.5~3 ㎜.
3. artificial valve according to claim 2, it is characterised in that：The leaflet unit includes the upper rectangle being integrally formed
With lower rectangle, the upper rectangle is connected with the lower rectangle by respective long side, and the long edge lengths of the upper rectangle are more than
The long edge lengths of the lower rectangle, two angles far from the upper rectangle of the lower rectangle remove and rounded corner, the upper square
It is suture ear at two short sides of shape, the edge of the lower rectangle is fixed edge, and the width of the fixed edge is 0.5~3 ㎜.
4. artificial valve according to claim 3, it is characterised in that：The leaflet unit of the leaflet is in the diaphragm seal
It is evenly arranged on the circumferencial direction in portion.
5. artificial valve according to claim 4, it is characterised in that：The suture side of two neighboring sealing film unit joining edge
Formula is the spiral suture way rack suture way that either two sides alternately passes through or matrix suture way or right-angled intersection seam
Conjunction mode.
6. artificial valve according to claim 4, it is characterised in that：The suture side of two neighboring sealing film unit joining edge
Formula is that the distance between the mode that lasso knots, two neighboring knotting node is 1~4 ㎜.
7. artificial valve according to claim 5 or 6, it is characterised in that：Suture way of the leaflet on diaphragm seal
For the rack suture way or spiral suture way alternately passed through between diaphragm seal and leaflet two sides along leaflet unit fixed edge
Either matrix suture way or zigzag suture way.
8. artificial valve according to claim 5 or 6, it is characterised in that：Suture way of the leaflet on diaphragm seal
Make each node T-shaped to be alternately passed through between diaphragm seal and leaflet two sides along leaflet fixed edge, between two neighboring node
Distance be 1~4 ㎜.
9. a kind of prosthetic valve apparatus, including artificial valve and valve frame, it is characterised in that：The valve frame for both ends in lotus shape,
Centre is in the network of straight-tube shape, and the valve frame is followed successively by upper, middle and lower from top to bottom, and the upper and lower part is in
The lotus shape, the middle part are in the straight-tube shape, and each portion is connected with each other by multiple rhomboids, the artificial valve
For claim 1~8 any one of them artificial valve, the outer flaring at the diaphragm seal both ends is in respectively lotus flower with the valve frame
The both ends of shape match, and match in the middle part of the middle part of the diaphragm seal and the valve frame, the diaphragm seal is sutured in the valve
On the inner wall of frame.
10. prosthetic valve apparatus according to claim 9, it is characterised in that：Between the top and middle part of the valve frame with
And connected between middle part and lower part by rigid montant, connect the uniform cloth of circumferential direction of rigid montant along the valve frame at top and middle part
It puts, the rigid montant of connection middle part and lower part is arranged in correspondingly between the rhomboid at middle part and the rhomboid of lower part, institute
The both ends for stating diaphragm seal are sewn to the both ends of the valve frame correspondingly in a manner of package respectively, and the artificial valve is in valve
Suture way on frame is that upper and lower end parts are the mode that lasso knots, remaining position is the composition rhomboid along valve frame
Bar around rod in a manner of stepped semi-circular sutures, and the distance of two neighboring semi-ring is 1~5 ㎜.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810116225.1A CN108125732A (en) | 2018-02-06 | 2018-02-06 | Artificial valve and prosthetic valve apparatus |
| PCT/CN2019/073156 WO2019154124A1 (en) | 2018-02-06 | 2019-01-25 | Prosthetic valve and prosthetic valve device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810116225.1A CN108125732A (en) | 2018-02-06 | 2018-02-06 | Artificial valve and prosthetic valve apparatus |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108125732A true CN108125732A (en) | 2018-06-08 |
Family
ID=62430371
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810116225.1A Pending CN108125732A (en) | 2018-02-06 | 2018-02-06 | Artificial valve and prosthetic valve apparatus |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN108125732A (en) |
| WO (1) | WO2019154124A1 (en) |
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| CN109172041A (en) * | 2018-11-21 | 2019-01-11 | 杭州嘉和众邦生物科技有限公司 | A kind of valved conduit and preparation method thereof |
| CN109549751A (en) * | 2018-11-21 | 2019-04-02 | 杭州嘉和众邦生物科技有限公司 | A kind of valved conduit and the method for making valved conduit |
| WO2019154124A1 (en) * | 2018-02-06 | 2019-08-15 | 北京迈迪顶峰医疗科技有限公司 | Prosthetic valve and prosthetic valve device |
| WO2021030244A1 (en) * | 2019-08-12 | 2021-02-18 | Edwards Lifesciences Corporation | Prosthetic heart valves |
| JP2022527076A (en) * | 2019-03-26 | 2022-05-30 | エドワーズ ライフサイエンシーズ コーポレイション | Artificial heart valve |
| CN115192263A (en) * | 2022-07-28 | 2022-10-18 | 上海化创医疗科技有限公司 | Surgical venous valve |
| CN115517819A (en) * | 2022-05-13 | 2022-12-27 | 科凯(南通)生命科学有限公司 | Transapical mitral valve replacement device |
| CN119055410A (en) * | 2024-10-24 | 2024-12-03 | 北京审谛医疗科技有限公司 | Cardiac outflow tract valved patch |
| CN119868015A (en) * | 2025-03-27 | 2025-04-25 | 国家心血管病中心 | Suture preparation method of polymer valve and related products |
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| US11833034B2 (en) | 2016-01-13 | 2023-12-05 | Shifamed Holdings, Llc | Prosthetic cardiac valve devices, systems, and methods |
| AU2019325548B2 (en) | 2018-08-21 | 2025-06-26 | Shifamed Holdings, Llc | Prosthetic cardiac valve devices, systems, and methods |
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| WO2022036022A1 (en) * | 2020-08-12 | 2022-02-17 | Edwards Lifesciences Corporation | Prosthetic heart valve |
| CN116456937A (en) | 2020-08-31 | 2023-07-18 | 施菲姆德控股有限责任公司 | Prosthetic Valve Delivery System |
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| CN109549751B (en) * | 2018-11-21 | 2024-01-09 | 杭州创心医学科技有限公司 | Valved conduit and method for manufacturing same |
| CN109549751A (en) * | 2018-11-21 | 2019-04-02 | 杭州嘉和众邦生物科技有限公司 | A kind of valved conduit and the method for making valved conduit |
| CN109172041A (en) * | 2018-11-21 | 2019-01-11 | 杭州嘉和众邦生物科技有限公司 | A kind of valved conduit and preparation method thereof |
| CN109172041B (en) * | 2018-11-21 | 2024-03-12 | 杭州创心医学科技有限公司 | Valved pipeline and preparation method thereof |
| US12186185B2 (en) | 2019-03-26 | 2025-01-07 | Edwards Lifesciences Corporation | Prosthetic heart valve |
| JP7520034B2 (en) | 2019-03-26 | 2024-07-22 | エドワーズ ライフサイエンシーズ コーポレイション | Artificial Heart Valves |
| JP2022527076A (en) * | 2019-03-26 | 2022-05-30 | エドワーズ ライフサイエンシーズ コーポレイション | Artificial heart valve |
| CN114025712A (en) * | 2019-08-12 | 2022-02-08 | 爱德华兹生命科学公司 | artificial heart valve |
| JP2022543971A (en) * | 2019-08-12 | 2022-10-17 | エドワーズ ライフサイエンシーズ コーポレイション | artificial heart valve |
| US20220160505A1 (en) * | 2019-08-12 | 2022-05-26 | Edwards Lifesciences Corporation | Prosthetic heart valves |
| JP7597745B2 (en) | 2019-08-12 | 2024-12-10 | エドワーズ ライフサイエンシーズ コーポレイション | Artificial Heart Valves |
| WO2021030244A1 (en) * | 2019-08-12 | 2021-02-18 | Edwards Lifesciences Corporation | Prosthetic heart valves |
| CN115517819A (en) * | 2022-05-13 | 2022-12-27 | 科凯(南通)生命科学有限公司 | Transapical mitral valve replacement device |
| CN115192263A (en) * | 2022-07-28 | 2022-10-18 | 上海化创医疗科技有限公司 | Surgical venous valve |
| CN119055410A (en) * | 2024-10-24 | 2024-12-03 | 北京审谛医疗科技有限公司 | Cardiac outflow tract valved patch |
| CN119055410B (en) * | 2024-10-24 | 2025-05-13 | 北京审谛医疗科技有限公司 | Cardiac outflow tract valved patch |
| CN119868015A (en) * | 2025-03-27 | 2025-04-25 | 国家心血管病中心 | Suture preparation method of polymer valve and related products |
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| WO2019154124A1 (en) | 2019-08-15 |
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Application publication date: 20180608 |