CN107773328A - Testing external performance system and its method of testing through conduit mitral valve support - Google Patents
Testing external performance system and its method of testing through conduit mitral valve support Download PDFInfo
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- CN107773328A CN107773328A CN201610720056.3A CN201610720056A CN107773328A CN 107773328 A CN107773328 A CN 107773328A CN 201610720056 A CN201610720056 A CN 201610720056A CN 107773328 A CN107773328 A CN 107773328A
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- mitral valve
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- valve support
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- circulation
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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
- A61F2/2472—Devices for testing
-
- 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
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/008—Means for testing implantable prostheses
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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
Testing external performance system and its method of testing through conduit mitral valve support, the prosthese being related in implantable, the more particularly, to test device and method of testing of cardiac valves performance test, include the valve test component of built-in mitral valve support, liquid circulating apparatus and monitoring device;First test department is the heart lung preparation that left ventricular apex portion has loop head, and the second test department is artificial blood vessel or the vascular specimen of the tested mitral valve support of one section of suture;Liquid circulating apparatus is connected with the first test department, is formed the first test loop path of steady motion of a fluid circulation or is simulated the second test loop path of human body ventricular beat;Liquid circulating apparatus is connected with the second test department, form the 3rd test loop path of circulation side shoot connection, hydrodynamic performance, support stationary state, valvular regurgitation, perivalvular leakage, the testing in vitro influenceed on vital tissue structure around of mitral valve support can be realized, completes the durability experiment of mitral valve support.
Description
Technical field
The present invention relates to the prosthese in implantable, more particularly to a kind of test device for cardiac valves performance test
And method of testing.
Background technology
Mitral valve disease is one of main heart disease at present, there is rheumatic, degeneration and the Different types of etiopathogenises such as congenital,
Surgical operation changes the Main Means that valve is mitral valve disease patient treatment, heart valve replacement surgery technology maturation, reliable, effect affirmative.But
Wound is big, risk is high, and with percutaneous aortic valve film replacement operation progressively promoting the use of in clinic, percutaneous mitral valve is put
The research changed also has caused the great interest of people.Bicuspid valve is complicated in anatomical structure, the positioning of intervention artificial valve is consolidated
Fixed difficulty, easily injures chordae tendineae or papillary muscle, postoperative easily to form the complication such as perivalvular leakage, left ventricular outflow tract view be narrow, so two points
The research relative difficulty of valve valve bracket.
2014, four doctors of St Thomas hospitals of Britain complete to be implanted into through conduit bicuspid valve earlier in the world
Art (TMVI), has made it possible mitral through conduit valve replacement, and existing a variety of mitral valve supports, which enter, at present faces
Bed conceptual phase.And lack through the relevant testing in vitro device of conduit mitral valve support.
It is inevitable it is to be understood that the properties of valve, the artificial valve research in China start from the research of artificial valve
Nineteen sixty-five, and it is the Tsing-Hua University since the eighties in last century to carry out system research for valve performance testing device
A series of systems for performance in vitro test are have developed, the technical merit that country reaches also according to this covering device, are formulated
The artificial valvular quality inspection standard in China.With progressively going deep into for valve research, vitro detection system also progressively obtains
To improve and perfect, but most test system, by the way that valve is directly sewn on valve frame, distal end connects the materials such as silicon rubber
Expect the active vascular that does, to test valve, and the fixing means of valve, position, and the size of active distal vascular, elastic size
Have an impact to test result.Through conduit valve bracket due to the particularity of its structure, implantation fixed form etc., in general valve
Test system is not particularly suited for the testing in vitro through conduit valve bracket.
(Chinese invention is special for the patent of invention " can be used for intervention valve and the device of other performance in vitro test " of China
Profit number:ZL200610116448.5, Authorization Notice No.:CN101147706B being used for of) disclosing that we previously develop intervenes valve
Film and the device of other performance in vitro test, including one can produce the oscillometer of Pulsating Flow and be connected with oscillometer can be interior
Put one section of (artificial) blood vessel of valve, and the part composition of outsourcing liquid capsule, the device through connect dynamical system, temperature varying system and
After resistance system testing external performance can be carried out to intervention valve and other artificial valves.It is left that one section of band is connected by oscillometer
The sustainer of ventricular outflow tract view, aortic valvular ring, intervention valve can be implanted on aorta petal, under the valve and position of annulus reaches
To the requirement of test intervention valve.The prior art scheme by be connected in test system one section can built-in valve (artificial)
Blood vessel, to test the performance through conduit valve bracket, this solves intervention valve bracket (mainly to intervene pulmonary valve
Film and intervention aortic valve) testing in vitro problem in the blood vessels.But for the external survey through conduit mitral valve support
Examination, because the rear position for being located at atrioventricular junction, the prior art scheme do not apply to simultaneously in mitral valve stenter to implant body.
Patent of invention " can be used for the in-vitro simulated release of intervention valve and performance testing device " (Chinese invention patent of China
Number:ZL201210422865.8, Authorization Notice No.:CN102949252B another) is disclosed to can be used for outside intervention valve body
Simulation release and the test device of performance, including software controlled machine, pulse driving device and in-vitro simulated device;Software controls
Device includes circuit integrated module and operation software, has Regulate signal output channel and data acquisition input channel, and pulse is driven
Dynamic device is power-driven mechanism, and in-vitro simulated device includes the ventricle of simulation human body, is connected to Supraventricularis artificial sustainer
Blood vessel, then connect by human body proportion from the arch of aorta until arcus aortae,artificial's blood vessel of femoral artery;In-vitro simulated dress
Put with for adjusting the temperature adjustment reponse system of the fluid temperature of circulation in the test device, intervening valve release and detecting
The middle camera system observed or taken pictures and for simulating the resistance of cardiovascular system of human body and the damping system of compliance.Should
Prior art is by the method for in-vitro simulated artificial left room, aorta vessel and coronary artery blood vessel, suitable for aortic valve
The test of support, do not applied to equally for the testing in vitro through conduit mitral valve support yet.
Above-mentioned prior art is primarily present following still unsolved technical problem:
1. intervene pulmonary valve valve bracket and intervene aorta petal valve bracket as circular design, and mitral valve
The global shape of support is often the design of the shape of a saddle, with the circular configuration of blood vessel not in full conformity with;Test position is using artificial
Left room, sustainer and design coronarius, also it is only used for testing aorta petal valve bracket in aortic valve position
Feature, it is impossible to be used in implant site is the survey of the mitral valve support of left room and left room boundary position (i.e. mitral position)
Examination.
2. because the fixing device on support directly affects the characteristic of support in the blood vessels, the fixation of mitral valve support
Feature and its to vital tissue structure around influence and mitral valve support testing in vitro important content, due to actively
Arteries and veins valve valve bracket using support in the blood vessels it is fixed by the way of, and mitral valve support mainly passes through the side of overhead kick in vivo
Formula is fixed, and the test position of above-mentioned prior art can not test the fixed character of mitral valve support and its to surrounding
The influence of vital tissue structure.
3. mitral haemodynamics is different from aorta petal, passage of the bicuspid valve between chamber, by the atrium of low pressure
Ventricle is flowed to, turning off makes the blood flow of ventricle to sustainer, and aorta petal flows to sustainer for the blood flow of left ventricle, so
Circulation loop during testing in vitro is entirely different, the simple test loop path by above-mentioned prior art, can not
Meet the testing in vitro requirement of mitral valve support.
The content of the invention
It is an object of the invention to provide a kind of testing external performance system through conduit mitral valve support, dedicated for
The testing external performance of mitral valve support, solves the still unsolved technical problem of above-mentioned prior art.
Technical scheme is used by the present invention solves above-mentioned technical problem:
A kind of testing external performance system through conduit mitral valve support, including built-in tested mitral valve branch
The valve test component of frame, the steady motion of a fluid or the liquid circulating apparatus of Pulsating Flow circulating liquid provided for valve test component, with
And for monitoring the monitoring device of valve bracket performance indications, it is characterised in that:
Described valve test component includes the first test department and the second test department;
The first described test department is the heart lung preparation that left ventricular apex portion has loop head;Described heart lung preparation includes
In vitro animal hearts or the simulation heart made using artificial material, described loop head are one section and are sewn to left ventricular apex portion
Artificial blood vessel or vascular specimen;The tested mitral valve support being implanted into by loop head or left room approach, with simulation
The mode discharged in vivo is discharged into heart lung preparation, is fixed on the anatomy portion complied fully with true mitral valve displacement technique
Position;
The second described test department is one section of diameter artificial blood vessel suitable with tested mitral valve support or blood vessel
Sample, tested mitral valve support be sewn to this section it is intravascular;The upper end open of blood vessel forms Doppler flow mapping entrance, two points
The lower end of valve valve sealing blood vessels, form the cavity of simulation left ventricle;
Described monitoring device includes the first pressure monitoring device for being connected to loop head, is connected to sustainer outlet
Second pressure monitoring device, and be placed in mitral valve support and backflow the meter that backflows of exit passageway;
Described liquid circulating apparatus includes producing Pulsating Flow and the circulating driving device of the steady motion of a fluid, for adjusting Cyclic Rings
The drag devices of roadlock power, and for storing the fluid reservoir of circulating liquid;
Described liquid circulating apparatus is connected with the first test department, form the steady motion of a fluid circulation the first test loop path or
Person simulates the second test loop path of human body ventricular beat;Described liquid circulating apparatus is connected with the second test department, is formed
Circulate the 3rd test loop path of side shoot connection;
Enter the circulating liquid of left ventricle via the first test loop path, backflowed by mitral valve support into left
Atrium simultaneously enters the meter that backflows through pulmonary vein, realizes perivalvular leakage and valvular regurgitation after the displacement of conduit mitral valve support
Testing in vitro;
Enter the circulating liquid of left ventricle via the second test loop path, entered again by pulmonary vein after sustainer submitting
Enter atrium sinistrum, left ventricle is returned via mitral valve support, form the Pulsating Flow circulation of simulation human body ventricular beat, realize two
The test monitoring that the stationary state of cusp valve bracket, valve activity, left ventricular outflow tract view influence, or carry out mitral valve and
The durability experiment of support;
Enter the steady motion of a fluid or Pulsating Flow circulating liquid of the second test department via the 3rd test loop path, pass through bicuspid valve
Valve bracket, which backflows, is directly entered the meter that backflows, and realizes testing in vitro and the evaluation of valvular regurgitation amount.
A kind of preferable technical scheme of the testing external performance system through conduit mitral valve support of the present invention, its
It is characterised by that the first described test loop path includes main circulation loop and valve bracket backflows branch road, described major cycle is returned
The liquid circulation path on road is:Loop head-the left ventricle in circulating driving device-first pressure monitoring device-left ventricular apex portion-
Left ventricular outflow tract view-aorta petal-sustainer-second pressure monitoring device-drag devices-fluid reservoir-circulating driving device;Circulation
Liquid forms the steady motion of a fluid circulated along main circulation loop under the driving of circulating driving device;Described valve bracket backflows branch
Lu Wei:Left ventricle-backflow mitral valve support-left-atrial pulmonary vein junction-meter;Valve week caused by mitral valve support
Leakage and valvular regurgitation, the meter that backflows is flowed into along mitral reflux branch road, carries out valvular regurgitation gauge amount.
A kind of superior technique scheme of the testing external performance system through conduit mitral valve support of the present invention, institute
The liquid circulation path for the second test loop path stated is:Circulating driving device-first pressure monitoring device-left ventricular apex portion
Loop head-left ventricle-left ventricular outflow tract view-aorta petal-sustainer-second pressure monitoring device-drag devices-liquid storage
Tank-pulmonary vein-atrium sinistrum-mitral valve support-left ventricle;Driving Imitating human body of the circulating liquid in circulating driving device
Left ventricle beating, formed and flow through the Pulsating Flow of mitral valve support.
A kind of preferable technical scheme of the testing external performance system through conduit mitral valve support of the present invention, its
It is characterised by that the 3rd described test loop path includes circulation side shoot link circuit and valvular regurgitation branch road, described circulation side
The liquid circulation path of branch link circuit is:Circulating driving device-first pressure monitoring device-Doppler flow mapping entrance-resistance dress
Put-fluid reservoir-circulating driving device;Circulating liquid is formed along circulation side shoot link circuit under the driving of circulating driving device
The steady motion of a fluid or Pulsating Flow of circulation;Described valvular regurgitation branch road enters from Doppler flow mapping entrance via mitral valve support to be returned
Flowmeter measuring device;Perivalvular leakage and valvular regurgitation caused by mitral valve support, the meter that backflows is flowed into along valvular regurgitation branch road, is entered
Row valvular regurgitation gauge amount.
A kind of improved technical scheme of the testing external performance system through conduit mitral valve support of the present invention, its
It is characterised by that described liquid circulating apparatus also includes the changing device for being connected to fluid reservoir, for adjusting the temperature of circulation of fluid
Make its control in the range of 35~40 DEG C, there is provided simulate the test environment of body temperature.
A kind of further improved technology of the testing external performance system through conduit mitral valve support of the present invention
Scheme, it is characterised in that described monitoring device also includes the super detection means of the heart that probe is placed in heart surface, and described is external
Performance Test System by through the super detection operation of the heart lung preparation surface heart, to valve bracket stationary state, valve active state and
Perivalvular leakage carries out inspection monitoring, and influence of the valve bracket to left ventricular outflow tract view is assessed in observation.
It is a further object to provide a kind of mitral valve support for above-mentioned testing external performance system
Testing external performance method, used technical scheme are:
A kind of outer performance test methods of mitral valve stake body for above-mentioned testing external performance system, its feature exist
In comprising the following steps:
Step 1:The heart lung preparation for forming the first test department is selected, one section is sutured in the left ventricular apex portion of heart lung preparation
Blood vessel is as loop head, under normal human's body temperature environment, loop head through left ventricular apex portion or is passed through through atrium sinistrum skidding
Conduit mitral valve Stent, tested mitral valve support is accurately planted under through the super guiding of the heart lung preparation surface heart
Enter mitral position;
Step 2:The main circulation loop of the first test department is connected according to the first test loop path setting and valve bracket returns
Branch road is flowed, starts circulating driving device and the steady motion of a fluid is provided, coordinates drag devices regulation circulating pressure, meter is collected using backflowing
The amount of liquid that backflows of left room side outflow is measured, calculates perivalvular leakage and valvular regurgitation after the displacement of conduit mitral valve support
Amount;
Step 3:The liquid circulation path of the first test department is connected according to the second test loop path setting, starts circulation and drives
Dynamic device provides the Pulsating Flow of simulation human body ventricular beat, by detecting operation through the heart lung preparation surface heart is super, to valve bracket
Stationary state, valve active state, left ventricular outflow tract view influence, perivalvular leakage and valvular regurgitation amount carry out ultrasonic monitoring.
A kind of preferable technical scheme of the outer performance test methods of the mitral valve stake body of the present invention, it is characterised in that
It is further comprising the steps of:
Step 4:One section of diameter artificial blood vessel suitable with tested mitral valve support or vascular specimen are selected, will be by
Test mitral valve support is sewn in artificial blood vessel or vascular specimen, forms the second test department;
Step 5:The circulation side shoot link circuit and valve of the second test department are connected according to the 3rd test loop path setting
Backflow branch road;Start circulating driving device and the steady motion of a fluid or Pulsating Flow are provided, coordinate drag devices regulation circulating pressure, using backflowing
Meter collects the amount of liquid that the mitral valve support of suture in metering intravascular backflows, and evaluates valvular regurgitation amount.
A kind of superior technique scheme of the outer performance test methods of the mitral valve stake body of the present invention, it is characterised in that
Described step 2 also includes the operation through the super detection of the heart lung preparation surface heart, stationary state, perivalvular leakage that can be to valve bracket
Influence to carry out ultrasonic monitoring with left ventricular outflow tract view.
A kind of improved technical scheme of the outer performance test methods of the mitral valve stake body of the present invention, it is characterised in that
Described step 3 also includes the operation that durability experiment is carried out to mitral valve support;By using drag devices and alternating temperature
Device adjusts the pressure and temperature of circulating liquid, can be to mitral valve support in different circulating pressures and different temperatures environment
Under durability assessed.
The beneficial effects of the invention are as follows:
1st, the testing external performance system and its method of testing through conduit mitral valve support of the invention, using complete
Cardiac module or heart lung preparation, coordinate the mitral valve support being implanted into delivery mode in analogue body through conduit, by changing
The connection become between the artificial blood vessel of atrium sinistrum, left ventricle, sustainer and the suture of left ventricular apex portion, structure is a variety of can to simulate two
The test loop path of cusp flow characteristic, realize the hydrodynamic performance, support stationary state, valve of mitral valve support
Backflow, perivalvular leakage, the testing in vitro influenceed on vital tissue structure around, can be the research through conduit mitral valve support
Technical support is provided with clinical practice.
2nd, the testing external performance system and its method of testing through conduit mitral valve support of the invention, will have been used
The second test department that first test department of whole heart lung preparation is connected artificial blood vessel or vascular specimen with circulation side shoot be combined with each other, real
The testing external performance and durability experiment of existing mitral valve support, can be significantly reduced through conduit mitral valve support
The cost of studies and clinical application experiment.
Brief description of the drawings
Fig. 1 is the structural representation of the first test department of the testing external performance system through conduit mitral valve support;
Fig. 2 is the structural representation of the second test department of the testing external performance system through conduit mitral valve support;
Fig. 3 is the first test loop path of the testing external performance system through conduit mitral valve support of the present invention
Schematic diagram;
Fig. 4 is the second test loop path of the testing external performance system through conduit mitral valve support of the present invention
Schematic diagram;
Fig. 5 is the 3rd test loop path of the testing external performance system through conduit mitral valve support of the present invention
Schematic diagram.
In figure, 10- mitral valve supports, the test departments of 20- first, the test departments of 21- second, 22- atrium sinistrums, the left hearts of 23-
Room, 24- left ventricular apexs portion, 25- left ventricular outflow tract views, 26- aorta petals, 27- sustainers, 28- pulmonary veins, 29- loop heads,
30- Doppler flow mapping entrances, 31- circulating driving devices, 32- first pressure monitoring devices, 33- second pressure monitoring devices, 34- resistances
Power apparatus, 35- fluid reservoirs, 36- changing devices, 37- backflow meter, the super detection means of the 38- hearts.
Embodiment
For better understanding of the above-mentioned technical proposal of the present invention, carry out with reference to the accompanying drawings and examples further
It is described in detail.
Fig. 3 to Fig. 5 is one embodiment of the testing external performance system through conduit mitral valve support of the present invention
As indicated, including the valve test component of built-in tested mitral valve support 10, provided for valve test component permanent
The liquid circulating apparatus of stream or Pulsating Flow circulating liquid, and for monitoring the monitoring device of valve bracket performance indications;
Described valve test component includes the first test department 20 and the second test department 21;
The first described test department 20 is the heart lung preparation that left ventricular apex portion 24 has loop head 29;Described heart mark
This, which includes in vitro animal hearts or the simulation heart made using artificial material, described loop head 29, is one section and is sewn to a left side
The artificial blood vessel of room apex 24 or vascular specimen;The tested mitral valve being implanted into by loop head 29 or left room approach
Support 10, is discharged into heart lung preparation in a manner of being discharged in analogue body, is fixed on complete with true mitral valve displacement technique
The region of anatomy met, referring to Fig. 1;
The second described test department 21 be one section of diameter artificial blood vessel suitable with tested mitral valve support 10 or
Vascular specimen, tested mitral valve support 10 be sewn to this section it is intravascular;The upper end open of blood vessel forms Doppler flow mapping and entered
Mouth 30, the lower end of mitral valve sealing blood vessels, the cavity for simulating left ventricle is formed, referring to Fig. 2;
Described monitoring device includes being connected to the of loop head (including loop head 29 or offshoot circulation entrance 30)
One pressure monitoring device 32, is connected to the second pressure monitoring device 33 of the outlet of sustainer 27, and is placed in mitral valve branch
Frame 10 backflows the meter 37 that backflows of exit passageway;The specific embodiment of the described meter 37 that backflows is placed in mitral valve
Support 10 backflow exit passageway measuring cup or other liquid containers with containing mark.
Described liquid circulating apparatus includes producing Pulsating Flow and the circulating driving device 31 of the steady motion of a fluid, is circulated for adjusting
The drag devices 34 of loop resistance, and for storing the fluid reservoir 35 of circulating liquid;Described circulating driving device 31 is to use
In the power drive unit for producing Pulsating Flow and the steady motion of a fluid;Described Pulsating Flow can adjust the frequency and pressure of pulsation, be used for
The ventricle drive system of simulation human body is provided, promotes the activity of distal end valve;The described steady motion of a fluid can adjust pressure size and
Flow velocity, the circulating liquid for providing smooth pressure flow.Described drag devices 34 are for adjusting circulation loop resistance
Device, resistance can be adjusted by way of adjusting circulation loop inner chamber size, for simulating blood circulation of human body system
Circulation resistance.
Described liquid circulating apparatus is connected with the first test department 20, forms the first test loop path of steady motion of a fluid circulation
Or the second test loop path of simulation human body ventricular beat;Described liquid circulating apparatus is connected with the second test department 21,
Form the 3rd test loop path of circulation side shoot connection;By first pressure monitoring device 32 and second pressure monitoring device 33
Instruction, can adjust the circulating pressure of each test loop path by adjusting drag devices 34.
Via the first test loop path enter left ventricle 23 circulating liquid, by mitral valve support 10 backflow into
Enter atrium sinistrum 22 and enter the meter 37 that backflows through pulmonary vein 28, realize the perivalvular leakage after the displacement of conduit mitral valve support
With valvular regurgitation testing in vitro;
Enter the circulating liquid of left ventricle 23 via the second test loop path, it is quiet by lung again after the submitting of sustainer 27
Arteries and veins 28 enters atrium sinistrum 22, returns to left ventricle 23 via mitral valve support 10, forms the pulsation of simulation human body ventricular beat
Stream circulation, realize the test monitoring that stationary state, valve activity, the left ventricular outflow tract view of mitral valve support influence, Huo Zhejin
The durability experiment of row mitral valve and support;
Enter the steady motion of a fluid or Pulsating Flow circulating liquid of the second test department 21 via the 3rd test loop path, pass through two points
Valve valve bracket, which backflows, is directly entered the meter 37 that backflows, and realizes testing in vitro and the evaluation of valvular regurgitation amount.
The embodiment of the testing external performance system of the invention through conduit mitral valve support according to Fig. 3,
The first described test loop path includes main circulation loop and valve bracket and backflowed branch road, the liquid of described main circulation loop
Circulating path is:The loop head 29- left ventricles in circulating driving device 31- first pressure monitoring device 32- left ventricular apexs portion 24
23- left ventricular outflow tract view 25- aorta petal 26- sustainer 27- second pressure monitoring device 33- drag devices 34- fluid reservoirs 35- is followed
Ring drive device 31;Circulating liquid forms the steady motion of a fluid circulated along main circulation loop under the driving of circulating driving device 31;Institute
The valve bracket the stated branch road that backflows is:Left ventricle 23- mitral valve support 10- atrium sinistrum 22- pulmonary veins 28- backflow meter
37;Perivalvular leakage and valvular regurgitation caused by mitral valve support 10, the meter 37 that backflows is flowed into along mitral reflux branch road, is entered
Row valvular regurgitation gauge amount.
The embodiment of the testing external performance system of the invention through conduit mitral valve support according to Fig. 4,
The liquid circulation path of the second described test loop path is:The left rooms of circulating driving device 31- first pressure monitoring device 32-
The loop head 29- left ventricle 23- left ventricular outflow tract view 25- aorta petal 26- sustainer 27- second pressures monitoring dress of apex 24
Put 33- drag devices 34- fluid reservoir 35- pulmonary vein 28- atrium sinistrums 22- mitral valve support 10- left ventricles 23;Circulating liquid
In the left ventricle beating of the driving Imitating human body of circulating driving device 31, the pulsation for flowing through mitral valve support 10 is formed
Stream.
The embodiment of the testing external performance system of the invention through conduit mitral valve support according to Fig. 5,
The 3rd described test loop path includes circulation side shoot link circuit and valvular regurgitation branch road, described circulation side shoot connect back to
The liquid circulation path on road is:Circulating driving device 31- first pressure monitoring device 32- Doppler flow mapping entrance 30- drag devices
34- fluid reservoir 35- circulating driving devices 31;Circulating liquid is formed and connected along circulation side shoot under the driving of circulating driving device 31
Connect the steady motion of a fluid or Pulsating Flow of circuit cycle;Described valvular regurgitation branch road is from Doppler flow mapping entrance 30 via mitral valve branch
Frame 10 enters the meter 37 that backflows;Perivalvular leakage and valvular regurgitation caused by mitral valve support 10, along valvular regurgitation branch road stream
Enter to backflow meter 37, carries out valvular regurgitation gauge amount.
In the implementation of the testing external performance system of the invention through conduit mitral valve support shown in Fig. 3 to Fig. 5
In example, described liquid circulating apparatus also includes the changing device 36 for being connected to fluid reservoir 35, for adjusting the temperature of circulation of fluid
Degree makes its control in the range of 35~40 DEG C, there is provided simulates the test environment of body temperature.
The reality of the testing external performance system of the invention through conduit mitral valve support according to Fig. 3 and Fig. 4
Example is applied, described monitoring device also includes the super detection means 38 of the heart that probe is placed in heart surface, described testing external performance
System to valve bracket stationary state, valve active state and perivalvular leakage by through the super detection operation of the heart lung preparation surface heart, entering
Row checks monitoring, and influence of the valve bracket to left ventricular outflow tract view is assessed in observation.
Mitral valve stake body for the testing external performance system through conduit mitral valve support of the present invention
One embodiment of outer performance test methods comprises the following steps:
Step 1:The heart lung preparation for forming the first test department 20 is selected, is sutured in the left ventricular apex portion 24 of heart lung preparation
One section of artificial blood vessel or vascular specimen are as loop head 29, under 37 DEG C or so of normal human's body temperature environment, through the left room heart
The loop head 29 of tip 24 or through atrium sinistrum skidding through conduit mitral valve Stent, through the heart lung preparation surface heart
Tested mitral valve support 10 is accurately implanted into mitral position under super guiding;
Step 2:The main circulation loop and valve bracket of the first test department 20 are connected according to the first test loop path setting
Backflow branch road, starts circulating driving device 31 and provides the steady motion of a fluid, coordinate drag devices 34 to adjust circulating pressure, utilizes metering of backflowing
Device 37 collects the amount of liquid that backflows of metering left room side outflow, calculates perivalvular leakage and valve after the displacement of conduit mitral valve support
Film regurgitation volume;This step adjusts circulating pressure, mould by adjusting the output pressure of circulating driving device 37, with reference to drag devices 34
Intend the perivalvular leakage and valvular regurgitation after the displacement of conduit mitral valve support;By collecting two points by the first test department 20
Valve valve bracket 10 backflows the amount of liquid of exit passageway (pulmonary vein 28) outflow, realize perivalvular leakage and valvular regurgitation amount metering and
Evaluation.
Step 3:The liquid circulation path of the first test department 20 is connected according to the second test loop path setting, starts circulation
Drive device 37 provides the Pulsating Flow of simulation human body ventricular beat, by being operated through the super detection of the heart lung preparation surface heart, to valve
Support stationary state, valve active state, left ventricular outflow tract view influence, perivalvular leakage and valvular regurgitation amount carry out ultrasonic monitoring.
According to one embodiment of performance test methods outside the mitral valve stake body of the present invention, in addition to following step
Suddenly:
Step 4:One section of diameter artificial blood vessel suitable with tested mitral valve support 10 or vascular specimen are selected, will
Tested mitral valve support 10 is sewn to this section of intravascular, the second test department 21 of composition;
Step 5:The circulation side shoot link circuit and valve of the second test department 21 are connected according to the 3rd test loop path setting
Film backflows branch road;Start circulating driving device 37 and the steady motion of a fluid or Pulsating Flow are provided, coordinate drag devices 34 to adjust circulating pressure, profit
The amount of liquid that the mitral valve support 10 sutured in metering intravascular backflows is collected with the meter 37 that backflows, evaluates valvular regurgitation
Amount.This step adjusts circulating pressure by adjusting the output pressure of circulating driving device 37, with reference to drag devices 34, simulates through leading
Valvular regurgitation after the displacement of pipe mitral valve support;Returned by collecting by the mitral valve support 10 of the second test department 21
The amount of liquid of flow export passage outflow, realizes the metering and evaluation of valvular regurgitation amount.
According to another embodiment of performance test methods outside the mitral valve stake body of the present invention, described step 2
Also include the operation through the super detection of the heart lung preparation surface heart, the stationary state of valve bracket, perivalvular leakage and left room can be flowed out
Road influences to carry out ultrasonic monitoring.
According to one embodiment of performance test methods outside the mitral valve stake body of the present invention, described step 3 is also
Operation including carrying out durability experiment to mitral valve support;Followed by using drag devices 34 and the regulation of changing device 36
The pressure and temperature of ring liquid, can be durable under different circulating pressures and different temperatures environment to mitral valve support 10
Property is assessed.
Those of ordinary skill in the art is it should be appreciated that the embodiment of the above is intended merely to the explanation present invention's
Technical scheme, and be not used as limitation of the invention, any connotation based on the present invention is to embodiment described above
Change, the modification made, it will all fall in the scope of the claims of the present invention.
Claims (10)
1. a kind of testing external performance system through conduit mitral valve support, including built-in tested mitral valve support
Valve test component, for valve test component provide the steady motion of a fluid or Pulsating Flow circulating liquid liquid circulating apparatus, and
For monitoring the monitoring device of valve bracket performance indications, it is characterised in that:
Described valve test component includes the first test department and the second test department;
The first described test department is the heart lung preparation that left ventricular apex portion has loop head;Described heart lung preparation includes in vitro
Animal hearts or the simulation heart made using artificial material, described loop head is one section of people for being sewn to left ventricular apex portion
Work blood vessel or vascular specimen;The tested mitral valve support being implanted into by loop head or left room approach, with analogue body
The mode of release is discharged into heart lung preparation, is fixed on the region of anatomy complied fully with true mitral valve displacement technique;
The second described test department is one section of diameter artificial blood vessel suitable with tested mitral valve support or vascular specimen,
Tested mitral valve support be sewn to this section it is intravascular;The upper end open of blood vessel forms Doppler flow mapping entrance, bicuspid valve valve
The lower end of membrane closure blood vessel, form the cavity of simulation left ventricle;
Described monitoring device includes the first pressure monitoring device for being connected to loop head, is connected to the second of sustainer outlet
Pressure monitoring device, and be placed in mitral valve support and backflow the meter that backflows of exit passageway;
Described liquid circulating apparatus includes producing Pulsating Flow and the circulating driving device of the steady motion of a fluid, for adjusting Cyclic Rings roadlock
The drag devices of power, and for storing the fluid reservoir of circulating liquid;
Described liquid circulating apparatus is connected with the first test department, forms the first test loop path or mould of steady motion of a fluid circulation
Second test loop path of anthropomorphic body ventricular beat;Described liquid circulating apparatus is connected with the second test department, forms circulation
3rd test loop path of side shoot connection;
Enter the circulating liquid of left ventricle via the first test loop path, backflowed by mitral valve support into atrium sinistrum
And enter the meter that backflows through pulmonary vein, realize that the perivalvular leakage after the displacement of conduit mitral valve support and valvular regurgitation are external
Test;
Enter the circulating liquid of left ventricle via the second test loop path, a left side is entered by pulmonary vein again after sustainer submitting
Atrium, left ventricle is returned to via mitral valve support, form the Pulsating Flow circulation of simulation human body ventricular beat, realize bicuspid valve
The test monitoring that stationary state, valve activity, the left ventricular outflow tract view of valve bracket influence, or carry out mitral valve and support
Durability experiment;
Enter the steady motion of a fluid or Pulsating Flow circulating liquid of the second test department via the 3rd test loop path, pass through mitral valve
Support, which backflows, is directly entered the meter that backflows, and realizes testing in vitro and the evaluation of valvular regurgitation amount.
2. the testing external performance system according to claim 1 through conduit mitral valve support, it is characterised in that institute
The the first test loop path stated includes main circulation loop and valve bracket and backflowed branch road, and the liquid of described main circulation loop follows
Endless path is:Loop head-the left ventricle in circulating driving device-first pressure monitoring device-left ventricular apex portion-left room outflow
Road-aorta petal-sustainer-second pressure monitoring device-drag devices-fluid reservoir-circulating driving device;Circulating liquid is being followed
Under the driving of ring drive device, the steady motion of a fluid circulated along main circulation loop is formed;The described valve bracket branch road that backflows is:Zuo Xin
Room-backflow mitral valve support-left-atrial pulmonary vein junction-meter;Perivalvular leakage and valve return caused by mitral valve support
Stream, the meter that backflows is flowed into along mitral reflux branch road, carries out valvular regurgitation gauge amount.
3. the testing external performance system according to claim 1 through conduit mitral valve support, described second surveys
The liquid circulation path of examination peripheral passage is:Circulating driving device-first pressure monitoring device-left ventricular apex portion is recycled into
Mouth-left ventricle-left ventricular outflow tract view-aorta petal-sustainer-second pressure monitoring device-drag devices-fluid reservoir-pulmonary vein-
Atrium sinistrum-mitral valve support-left ventricle;Circulating liquid is fought in the left ventricle of the driving Imitating human body of circulating driving device
It is dynamic, form the Pulsating Flow for flowing through mitral valve support.
4. the testing external performance system according to claim 1 through conduit mitral valve support, it is characterised in that institute
The 3rd test loop path stated includes circulation side shoot link circuit and valvular regurgitation branch road, described circulation side shoot link circuit
Liquid circulation path be:Circulating driving device-first pressure monitoring device-Doppler flow mapping entrance-drag devices-fluid reservoir-
Circulating driving device;Circulating liquid is formed along the permanent of circulation side shoot link circuit circulation under the driving of circulating driving device
Stream or Pulsating Flow;Described valvular regurgitation branch road enters the meter that backflows from Doppler flow mapping entrance via mitral valve support;
Valvular regurgitation caused by mitral valve support, the meter that backflows is flowed into along valvular regurgitation branch road, carries out valvular regurgitation gauge amount.
5. the testing external performance system according to claim 1 through conduit mitral valve support, it is characterised in that also
Changing device including being connected to fluid reservoir, the temperature for adjusting circulation of fluid make its control be carried in the range of 35~40 DEG C
Test environment for simulating body temperature.
6. the testing external performance system according to claim 1 through conduit mitral valve support, it is characterised in that institute
The monitoring device stated also includes probe and is placed in the super detection means of the heart of heart surface, described testing external performance system pass through through
The super detection operation of the heart lung preparation surface heart, inspection monitoring is carried out to valve bracket stationary state, valve active state and perivalvular leakage,
Influence of the valve bracket to left ventricular outflow tract view is assessed in observation.
A kind of 7. mitral valve branch of the testing external performance system described in any claim for claim 1 to 6
The outer performance test methods of support body, it is characterised in that comprise the following steps:
Step 1:The heart lung preparation for forming the first test department is selected, one section is sutured in the left ventricular apex portion of heart lung preparation manually
Blood vessel or vascular specimen are as loop head, under normal human's body temperature environment, loop head through left ventricular apex portion or through a left side
Atrial side is passed through conduit mitral valve Stent, by tested mitral valve under through the super guiding of the heart lung preparation surface heart
Support is accurately implanted into mitral position;
Step 2:The main circulation loop of the first test department is connected according to the first test loop path setting and valve bracket backflows branch
Road, start circulating driving device and the steady motion of a fluid is provided, coordinate drag devices regulation circulating pressure, meter collects metering using backflowing
The amount of liquid that backflows of atrium sinistrum side outflow, calculate perivalvular leakage and valvular regurgitation amount after the displacement of conduit mitral valve support;
Step 3:The liquid circulation path of the first test department is connected according to the second test loop path setting, starts circulation driving dress
The Pulsating Flow that simulation human body ventricular beat is provided is put, by through the super detection operation of the heart lung preparation surface heart, being fixed to valve bracket
State, valve active state, left ventricular outflow tract view influence, perivalvular leakage and valvular regurgitation amount carry out ultrasonic monitoring.
8. the outer performance test methods of mitral valve stake body according to claim 7, it is characterised in that also including following
Step:
Step 4:One section of diameter artificial blood vessel suitable with tested mitral valve support or vascular specimen are selected, will be tested
Mitral valve support is sewn in artificial blood vessel or vascular specimen, forms the second test department;
Step 5:The circulation side shoot link circuit and valvular regurgitation of the second test department are connected according to the 3rd test loop path setting
Branch road;Start circulating driving device and the steady motion of a fluid or Pulsating Flow are provided, coordinate drag devices regulation circulating pressure, utilize metering of backflowing
Device collects the amount of liquid that the mitral valve support of suture in metering intravascular backflows, and evaluates valvular regurgitation amount.
9. the outer performance test methods of mitral valve stake body according to claim 7, it is characterised in that described step 2
Also include the operation through the super detection of the heart lung preparation surface heart, the stationary state of valve bracket, perivalvular leakage and left room can be flowed out
Road influences to carry out ultrasonic monitoring.
10. the outer performance test methods of mitral valve stake body according to claim 7, it is characterised in that described step
3 also include the operation to mitral valve support progress durability experiment;Followed by using drag devices and changing device regulation
The pressure and temperature of ring liquid, durability that can be to mitral valve support under different circulating pressures and different temperatures environment
Assessed.
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