CN112773567A - Heart valve test fixture and use method thereof - Google Patents
Heart valve test fixture and use method thereof Download PDFInfo
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- CN112773567A CN112773567A CN202110216853.9A CN202110216853A CN112773567A CN 112773567 A CN112773567 A CN 112773567A CN 202110216853 A CN202110216853 A CN 202110216853A CN 112773567 A CN112773567 A CN 112773567A
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 141
- 238000012360 testing method Methods 0.000 title claims abstract description 111
- 238000000034 method Methods 0.000 title claims abstract description 16
- 238000000338 in vitro Methods 0.000 claims abstract description 16
- 239000012530 fluid Substances 0.000 claims description 19
- 239000000463 material Substances 0.000 claims description 13
- 238000011056 performance test Methods 0.000 claims description 6
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- 229920003023 plastic Polymers 0.000 claims description 4
- 239000004033 plastic Substances 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 3
- 230000008569 process Effects 0.000 abstract description 6
- 238000005457 optimization Methods 0.000 abstract description 5
- 238000012795 verification Methods 0.000 abstract description 5
- 238000013461 design Methods 0.000 abstract description 2
- 238000009434 installation Methods 0.000 description 10
- 238000009958 sewing Methods 0.000 description 6
- 238000005452 bending Methods 0.000 description 4
- 238000012545 processing Methods 0.000 description 4
- 238000007789 sealing Methods 0.000 description 4
- 238000005520 cutting process Methods 0.000 description 3
- 238000000465 moulding Methods 0.000 description 3
- 230000008859 change Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000009661 fatigue test Methods 0.000 description 2
- 208000019622 heart disease Diseases 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 238000010146 3D printing Methods 0.000 description 1
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- 210000001367 artery Anatomy 0.000 description 1
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- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 238000012994 industrial processing Methods 0.000 description 1
- 238000011221 initial treatment Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000877 morphologic effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
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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
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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
本发明涉及医疗器械测试设备技术领域，具体涉及一种心脏瓣膜测试夹具，由下至上依次包括夹具底座、固定座；所述夹具底座1包括导向内衬、法兰，所述导向内衬的侧壁上设置有导向内衬弧形开口；所述法兰上设置有若干卡槽；所述固定座的顶部侧壁上设置有连续的若干固定座弧形开口，所述固定座弧形开口之间分别设置有立柱；所述立柱上设置有连接间隙，所述固定座的底部侧壁上设置有若干个卡扣。该心脏瓣膜测试夹具用于瓣膜体外流体动力学测试，无需缝合即可将瓣膜快速固定在工装上，通过连接管道还可与各类体外流体力学测试设备相匹配，实现瓣膜的快速装卸及测试验证，缩短从设计到体外测试的周期，加快人工心脏瓣膜的迭代优化进程。
The invention relates to the technical field of medical device testing equipment, in particular to a heart valve testing fixture, which includes a fixture base and a fixing seat in order from bottom to top; the fixture base 1 includes a guide lining and a flange, and the side of the guide lining A guide lining arc-shaped opening is arranged on the wall; a plurality of clamping grooves are arranged on the flange; a continuous number of arc-shaped openings of the fixing seat are arranged on the top side wall of the fixing seat, and the arc-shaped openings of the fixing seat are arranged between them. Uprights are respectively arranged between the uprights; connection gaps are arranged on the uprights, and a plurality of buckles are arranged on the bottom side wall of the fixing seat. The heart valve test fixture is used for the in vitro hydrodynamic test of the valve. The valve can be quickly fixed on the tool without suturing. It can also be matched with various in vitro hydrodynamic testing equipment through the connecting pipeline, so as to realize the rapid loading and unloading of the valve and test verification. , shorten the cycle from design to in vitro testing, and speed up the iterative optimization process of artificial heart valves.
Description
Technical Field
The invention relates to the technical field of medical equipment testing equipment, in particular to a heart valve testing clamp and a using method thereof.
Background
The heart valves are located between the atria and ventricles and between the ventricles and the arteries, and mainly play a role in ensuring the unidirectional flow of blood. When a valve is diseased, stenosis or insufficiency often occurs, which leads to a series of heart diseases. Heart valve disease is a common heart disease, and currently, the primary treatment is replacement of prosthetic heart valves. The material properties, morphological structures and the like of the artificial heart valve have important influences on the functionality and durability of the artificial heart valve, so the functionality and fatigue of the artificial heart valve need to be tested continuously through an in-vitro test experiment of the valve so as to evaluate the performance index of the artificial heart valve.
At present, the existing heart valve test fixture is generally only suitable for a processed and molded artificial heart valve, and valve materials can be installed on valve test equipment for testing after a series of processing steps such as cutting, sewing, fixing and the like. The sewing and fixing processes of the valve need special technicians to complete the sewing and fixing processes for several days to several weeks, so that the period and the cost of the early-stage test of the artificial heart valve are greatly increased, and the research, the development and the optimization of the artificial heart valve are not facilitated.
Disclosure of Invention
On the basis of the common general knowledge in the field, the above-mentioned preferred conditions can be combined arbitrarily without departing from the concept and the protection scope of the invention.
In order to solve the technical problem, a first aspect of the present invention provides a heart valve testing fixture, which sequentially comprises a fixture base 1 and a fixing base 2 from bottom to top;
the clamp base 1 comprises a guide lining 11 and a flange 12, wherein a continuous guide lining arc-shaped opening 15 is formed in the side wall of the top of the guide lining 11, and an inner side ring of the flange 12 is fixedly connected with the bottom of the guide lining 11; a plurality of clamping grooves 13 are formed in the flange 12;
the fixing seat 2 is of a cylindrical structure, a plurality of continuous fixing seat arc-shaped openings 24 are formed in the side wall of the top of the fixing seat 2, and the upright posts 21 are respectively arranged between the fixing seat arc-shaped openings 24; a connecting gap 22 is formed in the upright post 21, and a plurality of buckles 23 are arranged on the side wall of the bottom of the fixed seat 2; the buckle 23 is matched with the card slot 13.
As a preferable technical solution, support columns 14 are respectively disposed between two ends of the arc-shaped opening 15 of the guide liner in the present invention.
As a preferable technical solution, the number of the guide liner arc-shaped openings 15 and the number of the fixing seat arc-shaped openings 24 are at least 3 respectively.
As a preferable technical solution, the fixing manner between the buckle 23 and the slot 13 in the present invention is selected from clamping and spring buckling.
As a preferable technical solution, in the present invention, the connection gap 22 on the upright post 21 is a long groove penetrating from inside to outside, and the connection gap 22 extends downward to the bottom of the fixing base 2.
As a preferable technical solution, the number of the snap 23 and the slot 13 is 2-8.
In a preferred embodiment of the present invention, the material of the fixture base 1 and the material of the fixing base 2 are at least one selected from metal and plastic.
In a second aspect, the present invention provides a method for using the heart valve test fixture of the present invention, comprising the steps of:
step (1): placing the heart valve 4 on the outer wall of the guide lining 11 of the clamp base 1, and placing the attachment edge 43 of the heart valve 4 in alignment with the arc-shaped opening 15 of the guide lining;
step (2): after the fixing seat 2 and the clamp base 1 are coaxially aligned, the fixing seat is fixed in the clamping groove 13 through the buckle 23, the fixing seat arc-shaped opening 24 is aligned with the attachment edge 43 of the heart valve 4, so that the heart valve 4 is positioned between the guide lining arc-shaped opening 15 and the fixing seat arc-shaped opening 24, the attachment edge 43 is aligned with the guide lining arc-shaped opening 15 and the fixing seat arc-shaped opening 24, and the heart valve testing clamp is assembled with the heart valve 4.
As a preferred technical solution, the method for using the heart valve test fixture further comprises the step (3): and placing the assembled heart valve test fixture and the heart valve 4 into a connecting pipeline, wherein the port joints at two sides of the connecting pipeline are connected with valve in-vitro fluid dynamics test equipment, so that the in-vitro performance test of the heart valve can be carried out.
As a preferred technical solution, the connection pipe includes a first connection pipe 51, a second connection pipe 52; the first connecting pipe 51 and the second connecting pipe 52 are in flange connection; the connection ends of the first connection pipe 51 and the second connection pipe 52 are respectively provided with an inner fastening position, the outer ring of the flange 12 is placed at the inner fastening position, and the first connection pipe 51 and the second connection pipe 52 are fixedly assembled through the flange.
Compared with the prior art, the invention has the following remarkable advantages and effects:
the invention provides a heart valve test fixture which comprises a fixture base and a fixing seat. The fixture base is a cap-shaped structure with a through hole and a crown flange, the fixing seat is a crown-shaped groove sleeve with a corresponding shape, and the fixture base and the fixing seat are connected and fixed in a nesting mode. The heart valve is clamped and fixed between the clamp base and the fixing seat. The heart valve test fixture can be quickly clamped with a pipeline of the valve extracorporeal fluid dynamics test equipment through a flange on the base. The heart valve test fixture is used for valve extracorporeal fluid dynamics test, the valve can be quickly fixed on a tool without sewing, the heart valve can be matched with various extracorporeal fluid dynamics test equipment through a connecting pipeline, quick assembly and disassembly and test verification of the valve are achieved, the period from design to extracorporeal test is shortened, and the iterative optimization process of the artificial heart valve is accelerated. The heart valve test fixture avoids the complex operation that valve materials are usually required to be sewn on the valve frame and then assembled on the customized fixture in the current valve test, and can realize the quick assembly and disassembly and the test verification of the heart valve in the extracorporeal fluid dynamics test through simple steps of positioning, nesting and fixing. The clamp can greatly simplify the flow and preparation time of valve material performance test, and is beneficial to the research and development and optimization of heart valve materials. The invention has simple structure and each characteristic can be designed in a customized way. The heart valve test fixture can be compatible with valve structures with different shapes and sizes, symmetry or asymmetry according to the processing customization and differentiation of the test valve. The clamp can also be connected directly to the extracorporeal hydrodynamic test device of the valve by means of a customizable connection duct. The heart valve test fixture can be directly used as a valve fixture of valve extracorporeal fluid dynamics test equipment, has a simple structure and easy assembly, can realize quick assembly and disassembly and test verification of the heart valve, and quickens the flow of valve function test and iterative optimization.
Drawings
Fig. 1 is a schematic structural diagram of a heart valve test fixture disclosed in embodiment 1 of the present invention.
Fig. 2 is an exploded view of the heart valve test fixture disclosed in example 1 of the present invention.
Figure 3 is an isometric view of a fixture base disclosed in embodiment 1 of the present invention.
Fig. 4 is a top view of the fixture base disclosed in embodiment 1 of the present invention.
Fig. 5 is an isometric view of the mounting block disclosed in embodiment 1 of the present invention.
Fig. 6 is a schematic view of a heart valve as disclosed in example 1 of the present invention.
Fig. 7 is a schematic view of the installation of a heart valve as disclosed in example 1 of the present invention.
Fig. 8 is an exploded view of the assembly of the heart valve test fixture and the connecting tube disclosed in example 1 of the present invention.
FIG. 9 is a cross-sectional view of the assembly of the heart valve test fixture and the connecting tube disclosed in example 1 of the present invention.
Fig. 10 is a schematic view of a heart valve test fixture disclosed in example 2 of the present invention.
Figure 11 is an isometric view of a fixture base disclosed in embodiment 2 of the present invention.
Fig. 12 is a schematic view of a heart valve as disclosed in example 2 of the present invention.
Fig. 13 is a schematic view of the installation of a heart valve as disclosed in example 2 of the present invention.
Figure 14 is a schematic illustration of a heart valve formation as disclosed in example 2 of the present invention.
Description of reference numerals:
1-a clamp base; 2-a fixed seat; 4-a heart valve; 11-a guide liner; 12-a flange; 13-a card slot; 14-a support column; 15-guiding the arc-shaped opening of the lining; 21-erecting a rod; 22-a connection gap; 23-buckling; 24-arc opening of the fixed seat; 41-valve leaflet; 42-a joint edge; 43-attaching the edge; 44-a valve fixation area; 51-a first connection tube; 52-second connecting tube.
Detailed Description
The technical solutions of the present invention are described in detail below with reference to the drawings and the embodiments, but the present invention is not limited to the scope of the embodiments. In order to overcome the defect that most of the existing valve test clamps are only suitable for processing, assembling and forming the artificial heart valve, the invention provides a heart valve test clamp for valve extracorporeal fluid dynamics test, which is used for realizing the quick assembly and disassembly and test verification of new materials and new structures of the artificial heart valve. The heart valve test fixture provided by the invention is mainly used for extracorporeal fluid dynamic tests (including but not limited to pulsating flow tests, steady-state flow tests, fatigue tests and the like) of valves.
The invention provides a heart valve test fixture, which comprises a fixture base 1 and a fixed seat 2 from bottom to top in sequence;
the clamp base 1 comprises a guide lining 11 and a flange 12, wherein a continuous guide lining arc-shaped opening 15 is formed in the side wall of the top of the guide lining 11, and an inner side ring of the flange 12 is fixedly connected with the bottom of the guide lining 11; a plurality of clamping grooves 13 are formed in the flange 12;
the fixing seat 2 is of a cylindrical structure, a plurality of continuous fixing seat arc-shaped openings 24 are formed in the side wall of the top of the fixing seat 2, and the upright posts 21 are respectively arranged between the fixing seat arc-shaped openings 24; a connecting gap 22 is formed in the upright post 21, and a plurality of buckles 23 are arranged on the side wall of the bottom of the fixed seat 2; the buckle 23 is matched with the card slot 13.
In some embodiments, the guide liner 11 is a hollow cylinder structure, and the top side wall of the guide liner 11 is provided with continuous guide liner arc-shaped openings 15 arranged along the circumferential direction of the guide liner 11.
In some embodiments, the guide liner arcuate opening 15 conforms to the shape of the attachment edge 43 of the heart valve 4.
In some embodiments, the flange 12 is generally circular, and the size, thickness, shape, etc. of the flange are matched with the target test equipment installation area, and the circular inner side of the flange 12 is fixedly connected with the bottom of the guide lining 11; the flange 12 is provided with a plurality of clamping grooves 13 near the inner side of the circular ring, and the plurality of clamping grooves 13 are arranged along the circumferential direction of the flange 12.
In some embodiments, the holder 2 is a hollow crown cylinder.
In some embodiments, the holder arc openings 24 are distributed along the circumference of the top of the holder 2.
In some embodiments, the bottom of the fixing base 2 is provided with a plurality of protruding buckles 23, the number and the positions of the buckles 23 are the same as those of the clamping grooves on the fixture base, and the buckles 23 can be clamped in the clamping grooves 13 in the fixture base 1.
Alternatively, the buckle 23 and the card slot 13 may be connected by snap-fit, spring-fit, or the like.
In the invention, the clamp base comprises a guide lining and a flange, the guide lining of the base is a hollow cylinder, and three arc-shaped openings are formed in the side wall of the guide lining. The clamp base flange can be matched with valve extracorporeal fluid dynamics testing equipment, and a clamping groove is formed in the flange. The fixing base cross section is circular, is provided with three pole settings along the circumferencial direction, is equipped with long banding joint gap in the pole setting, is the fixing base arc opening between the pole setting, and the shape is unanimous with anchor clamps base direction inside lining. The bottom of the fixed seat is provided with a convex buckle. The heart valve is placed between the outer wall of the guide lining of the clamp base and the inner wall of the fixing base, the buckle is assembled with the clamping groove of the flange of the clamp base, and the joint edge of the valve leaflet is connected through the connecting gap to complete the fixation of the heart valve.
In some preferred embodiments, the flange is generally cylindrical in shape, fitting the valve function testing device or valve fatigue testing device installation requirements. The flange is provided with three arc-shaped clamping grooves which are distributed along the circumferential direction. The cross section of the guide lining is circular, and three arc-shaped openings are distributed on the ring surface. The arc-shaped opening is matched with the attachment edge shape of the test valve.
In the invention, the heart valve is arranged in the base and the fixed seat. The attachment edge of the valve root is attached and positioned on the inner side surface of the coronary clamping groove of the fixing seat, the joint edge of the valve is attached and positioned on the inner side of the vertical rod of the fixing seat, the joint edge of the valve also can penetrate through the long groove in the vertical rod to be positioned on the outer side of the fixing seat, and then the valve is firmly clamped between the inner cylinder structure and the outer cylinder structure through the embedding of the clamp base and the fixing seat, so that the.
In the present invention, the heart valve test fixture may be custom designed according to specific valve test requirements. According to the shape and size of the heart valve to be tested, the arc-shaped opening of the guide lining and the arc-shaped opening of the fixing seat can be uniformly or non-uniformly, symmetrically or non-symmetrically distributed along the circumferential direction, and the size and shape of the arc-shaped opening of the guide lining and the arc-shaped opening of the fixing seat are matched with the valve to be tested. The flange of the clamp base is generally annular and is matched with target valve extracorporeal fluid dynamics testing equipment through a connecting pipeline with matched shape.
In some embodiments, support posts 14 are provided at positions between the two ends of the guide liner arcuate opening 15, respectively.
In some embodiments, the number of the guide liner arc-shaped openings 15 and the number of the fixing seat arc-shaped openings 24 are at least 3; preferably, the number of the guide lining arc-shaped opening 15 and the number of the fixing seat arc-shaped openings 24 are respectively 3.
In some embodiments, the fastening means between the clip 23 and the clip groove 13 is selected from snap-fit, spring-fit; preferably, the fixing mode between the buckle 23 and the clamping groove 13 is selected from clamping.
In some embodiments, the connecting gap 22 on the upright 21 is a long groove penetrating from inside to outside, and the connecting gap 22 extends downward to the bottom of the fixing base 2.
In some embodiments, the number of the buckles 23 and the card slots 13 is 2-8; preferably, the number of the buckles 23 and the card slots 13 is 3.
The buckles 23 and the clamping grooves 13 can be uniformly or non-uniformly arranged along the circumferential direction.
In some embodiments, the material of the fixture base 1 and the fixture base 2 is at least one selected from metal and plastic; preferably, the material of the clamp base 1 and the material of the fixing base 2 are respectively selected from plastics.
The processing mode of the clamp base and the fixed seat can select industrial processing or 3D printing.
In the invention, when the heart valve test fixture is used, the heart valve 4 is firstly placed on the outer wall of the guide lining 11 in the fixture base 1 and is tightly attached to the outer wall of the guide lining 11. The heart valve 4 is positioned with its attachment edge 43 aligned with the guide liner arcuate opening 15.
In the present invention, a second aspect provides a method for using the heart valve test fixture of the present invention, comprising the steps of:
step (1): placing the heart valve 4 on the outer wall of the guide lining 11 of the clamp base 1, and placing the attachment edge 43 of the heart valve 4 in alignment with the arc-shaped opening 15 of the guide lining;
step (2): after the fixing seat 2 and the clamp base 1 are coaxially aligned, the fixing seat is fixed in the clamping groove 13 through the buckle 23, the fixing seat arc-shaped opening 24 is aligned with the attachment edge 43 of the heart valve 4, so that the heart valve 4 is positioned between the guide lining arc-shaped opening 15 and the fixing seat arc-shaped opening 24, the attachment edge 43 is aligned with the guide lining arc-shaped opening 15 and the fixing seat arc-shaped opening 24, and the heart valve testing clamp is assembled with the heart valve 4.
In some preferred embodiments, the method for using the heart valve test fixture further comprises the step (3): and placing the assembled heart valve test fixture and the heart valve 4 into a connecting pipeline, wherein the port joints at two sides of the connecting pipeline are connected with valve in-vitro fluid dynamics test equipment, so that the in-vitro performance test of the heart valve can be carried out.
In some preferred embodiments, the connection pipes include a first connection pipe 51, a second connection pipe 52; the first connecting pipe 51 and the second connecting pipe 52 are in flange connection; the connection ends of the first connection pipe 51 and the second connection pipe 52 are respectively provided with an inner fastening position, the outer ring of the flange 12 is placed at the inner fastening position, and the first connection pipe 51 and the second connection pipe 52 are fixedly assembled through the flange.
In the present invention, the valve fixing region 44 under the attachment edge 43 can be fixed to the outer wall of the guide liner 11 by means of adhesion, thermal molding, or the like, or can be fixed only by clamping the guide liner 11 and the fixing base 2. The leaflets 41 are folded inwardly to obtain the final valve configuration. The joint edge 42 of the heart valve 4 passes through the connecting gap 22 from inside to outside, and can be fixed on the upright rod 21 by sewing, adhering and the like, so as to complete the installation of the heart valve 4. The upright 21 is outside the heart valve 4 and does not affect the movement and deformation of the heart valve 4.
The valve test fixture of the invention can be connected with an extracorporeal fluid mechanics testing device through a connecting pipeline 5 which can change the shape. The connecting pipe 5 shown in fig. 8 and 9 can be connected with the test fixture main body in an end face sealing and fixing mode, so that the valve test fixture is ensured not to be washed away by water flow in the test process while sealing is realized. The inner buckling position of the connecting pipeline 5 is matched with the flange 12. After the installation of the heart valve 4 is completed, the flange 12 of the heart valve test fixture base is buckled and assembled with the connecting pipeline 5, the fixing can be carried out through bolts, the port joints at the left side and the right side of the connecting pipeline 5 are connected with the valve in-vitro fluid dynamics test equipment, and the in-vitro performance test of the heart valve can be carried out quickly. Alternatively, the connection of the port of the connecting pipeline 5 can be butted with various interfaces of extracorporeal fluid mechanics tests by adopting connection modes such as a pagoda joint, a cutting sleeve joint and the like.
In another embodiment, support columns 14 are respectively disposed at positions between two ends of the arc-shaped opening 15 of the guide liner. The two ends of the arc-shaped opening 15 of the guide lining are provided with 3 support columns 14 in total, and the support columns 14 are arranged along the circumferential direction of the guide lining.
In some preferred embodiments, when the heart valve test fixture is assembled, the heart valve 4 is located between the guide liner 11 and the holder 2. After assembly, the exposed portion of the prosthetic heart valve 4 is the area of the valve leaflet 41, and by applying a slight inward pressure to this area, the heart valve 4 is bent inward, with the bent edge just aligned with the holder arcuate opening 24, forming the attachment edge 43 of the heart valve 4. The heart valve 4 cannot move inwardly at the point of contact with the support posts 14 due to the obstruction of the support posts 14 during bending, thereby forming a combined edge 42. The heart valve 4 can be quickly shaped into the tested valve configuration by bending.
The experimental methods without specifying specific conditions in the following examples were selected according to the conventional methods and conditions, or according to the commercial instructions. The reagents and starting materials used in the present invention are commercially available.
Example 1
A heart valve test fixture is shown in figures 1-9 and comprises a fixture base 1 and a fixed seat 2 in sequence from bottom to top;
the jig base 1 includes a guide liner 11 and a flange 12. The guide lining 11 is a hollow cylinder, the side wall of the guide lining 11 is provided with 3 guide lining arc-shaped openings 15 which are distributed along the circumferential direction of the guide lining 11, the flange 12 is generally in a circular ring shape, the size, the thickness, the shape and the like are matched with the installation area of target test equipment, and the inner side of the circular ring of the flange 12 is fixedly connected with the bottom of the guide lining 11. The flange 12 is provided with 3 draw-in grooves 13 near the ring inboard, and 3 draw-in grooves 13 are arranged along flange 12 circumferencial direction.
The fixing seat 2 is a hollow crown-shaped cylinder, 3 fixing seat arc-shaped openings 24 are arranged on the side wall of the fixing seat 2, and the 3 fixing seat arc-shaped openings 24 are distributed along the circumferential direction of the fixing seat 2. 3 pole setting 21 are provided with between the fixing base arc opening 24, and 3 pole setting 21 are arranged along 2 circumferencial directions of fixing base. An elongated slot penetrating from inside to outside is arranged in the upright rod 21, the elongated slot is a connecting gap 22, and the connecting gap 22 extends to the bottom of the fixed seat 2. The bottom of the fixing seat 2 is provided with 3 convex buckles 23, the number and the positions of the buckles 23 are the same as those of the clamping grooves in the fixture base, and the buckles 23 can be clamped in the clamping grooves 13 in the fixture base 1. The buckle 23 and the card slot 13 can be connected in a clamping manner.
When the heart valve test fixture disclosed in the embodiment is used, the heart valve 4 is firstly placed on the outer wall of the guide lining 11 in the fixture base 1 and is tightly attached to the outer wall of the guide lining 11. The heart valve 4 is positioned with its attachment edge 43 aligned with the guide liner arcuate opening 15. After the fixing seat 2 is coaxially aligned with the clamp base 1, the position of the buckle 23 is aligned with the clamping groove 13 on the clamp base 1 by rotating the fixing seat 2, and the fixing seat 2 is moved close to the clamp base 1 along the axial direction. The buckle 23 is clamped in the clamping groove 13, the arc-shaped opening 24 of the fixing seat is just aligned with the attachment edge of the heart valve, and the clamp base 1 and the fixing seat 2 are assembled. When the assembly of the heart valve test fixture is completed, the heart valve 4 is positioned between the guide lining 11 and the fixing seat 2, and the positions of the attachment edge 43, the guide lining arc-shaped opening 15 and the fixing seat arc-shaped opening 24 are aligned. The valve fixing area 44 under the attachment edge 43 can be fixed to the outer wall of the guide liner 11 by means of gluing, heat molding, or the like, or can be fixed only by clamping the guide liner 11 and the fixing base 2. The leaflets 41 are folded inwardly to obtain the final valve configuration. The joint edge 42 of the heart valve 4 passes through the connecting gap 22 from inside to outside, and can be fixed on the upright rod 21 by sewing, adhering and the like, so as to complete the installation of the heart valve 4. The upright 21 is outside the heart valve 4 and does not affect the movement and deformation of the heart valve 4.
The valve test fixture of the invention can be connected with an extracorporeal fluid mechanics testing device through a connecting pipeline 5 which can change the shape. The connecting pipe 5 shown in fig. 8 and 9 can be connected with the test fixture main body in an end face sealing and fixing mode, so that the valve test fixture is ensured not to be washed away by water flow in the test process while sealing is realized. The inner buckling position of the connecting pipeline 5 is matched with the flange 12. After the installation of the heart valve 4 is completed, the flange 12 of the heart valve test fixture base is buckled and assembled with the connecting pipeline 5, the fixing can be carried out through bolts, the port joints at the left side and the right side of the connecting pipeline 5 are connected with the valve in-vitro fluid dynamics test equipment, and the in-vitro performance test of the heart valve can be carried out quickly. Alternatively, the connection of the port of the connecting pipeline 5 can be butted with various interfaces of extracorporeal fluid mechanics tests by adopting connection modes such as a pagoda joint, a cutting sleeve joint and the like.
The heart valve test fixture disclosed by the embodiment can be used for rapidly assembling and fixing the heart valve, is simple and convenient to use and operate, and can be used for rapidly assembling, disassembling and testing and verifying the heart valve.
Example 2
Based on the embodiment described in example 1, example 2 discloses another embodiment of the present invention, and this example provides a heart valve test fixture, as shown in fig. 10 to 12, which comprises a fixture base 1 and a fixing base 2 in sequence from bottom to top; the holder 2 corresponds to that described in example 1.
This embodiment differs from embodiment 1 in that the jig base 1 includes a guide liner 11 and a flange 12. The side wall of the guide lining 11 is provided with 3 guide lining arc-shaped openings 15 which are arranged along the circumferential direction of the guide lining 11. The two ends of the arc-shaped opening 15 of the guide lining are provided with 3 support columns 14 in total, and the support columns 14 are arranged along the circumferential direction of the guide lining.
When the heart valve test fixture disclosed by the embodiment is used, the heart valve 4 is curled into a cylindrical shape, and the artificial heart valve 4 is nested on the outer wall of the guide lining 11 in the fixture base 1 and is tightly attached to the outer wall of the guide lining 11. After the fixing seat 2 is coaxially aligned with the clamp base 1, the position of the buckle 23 is aligned with the clamping groove 13 on the clamp base 1 by rotating the fixing seat 2, and the fixing seat 2 is moved close to the clamp base 1 along the axial direction. The buckle 23 is clamped in the clamping groove 13, and the clamp base 1 and the fixing seat 2 are assembled. The heart valve 4 and the outer wall of the guide lining 11 are fixed on the outer wall of the guide lining 11 by means of sticking, heat molding and the like, or are fixed only by clamping the guide lining 11 and the fixed seat 2. When the heart valve test fixture is assembled, the heart valve 4 is positioned between the guide lining 11 and the fixing seat 2. After assembly, the exposed portion of the prosthetic heart valve 4 is the area of the valve leaflet 41, and by applying a slight inward pressure to this area, the heart valve 4 is bent inward, with the bent edge just aligned with the holder arcuate opening 24, forming the attachment edge 43 of the heart valve 4. The heart valve 4 cannot move inwardly at the point of contact with the support posts 14 due to the obstruction of the support posts 14 during bending, thereby forming a combined edge 42. The heart valve 4 can be quickly shaped into the tested valve configuration by bending.
The heart valve test fixture disclosed by the embodiment can quickly form the heart valve 4 into a valve shape, realizes the forming and installation of the valve, and is used for testing the valve in-vitro fluid dynamics test equipment, so that the in-vitro test flow of the heart valve material is greatly shortened.
The embodiments of the present invention have been described in detail with reference to the accompanying drawings, but the present invention is not limited to the above embodiments, and the above is only a preferred embodiment of the present invention, and is not limited to the present invention. Variations may be made without departing from the spirit of the invention within the knowledge of one of ordinary skill in the art. The present invention is not limited to the above-described embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents and are included in the scope of the present invention.
Claims (10)
1. A heart valve test fixture is characterized by sequentially comprising a fixture base (1) and a fixed seat (2) from bottom to top;
the clamp base (1) comprises a guide lining (11) and a flange (12), wherein a continuous guide lining arc-shaped opening (15) is formed in the side wall of the top of the guide lining (11), and an inner side ring of the flange (12) is fixedly connected with the bottom of the guide lining (11); the flange (12) is provided with a plurality of clamping grooves (13);
the fixing seat (2) is of a cylindrical structure, a plurality of continuous fixing seat arc-shaped openings (24) are formed in the side wall of the top of the fixing seat (2), and vertical columns (21) are arranged between the fixing seat arc-shaped openings (24); a connecting gap (22) is formed in the upright column (21), and a plurality of buckles (23) are arranged on the side wall of the bottom of the fixed seat (2); the buckle (23) is matched with the clamping groove (13).
2. The heart valve test fixture of claim 1, wherein support posts (14) are provided at positions between the two ends of the guide liner arcuate opening (15), respectively.
3. The heart valve test fixture of claim 1, wherein the number of the guide liner arc-shaped openings (15) and the number of the fixing seat arc-shaped openings (24) are at least 3 respectively.
4. The heart valve test fixture of claim 1, wherein the fastening means between the snap (23) and the locking groove (13) is selected from snap-fit or spring-fit.
5. The heart valve test fixture of claim 1, wherein the connecting gap (22) on the upright (21) is an elongated slot penetrating from inside to outside, and the connecting gap (22) extends downwards to the bottom of the fixed base (2).
6. The heart valve test fixture of claim 1, wherein the number of the snap (23) and the snap groove (13) is 2-8.
7. The heart valve test fixture of claim 1, wherein the fixture base (1) and the fixing seat (2) are made of at least one material selected from metal and plastic.
8. A method of using the heart valve test fixture of any of claims 1-7, the steps comprising:
step (1): placing the heart valve (4) on the outer wall of the guide lining (11) of the clamp base (1) so that the attachment edge (43) of the heart valve (4) is aligned with the arc-shaped opening (15) of the guide lining;
step (2): fix fixing base (2) and coaxial alignment back of anchor clamps base (1), fix in draw-in groove (13) through buckle (23), fixing base arc opening (24) are aligned with adhering to edge (43) of heart valve (4) and are placed for heart valve (4) are in between direction inside lining arc opening (15), fixing base arc opening (24), and adhere to edge (43) and direction inside lining arc opening (15), fixing base arc opening (24) position and align, heart valve test fixture accomplishes the assembly with heart valve (4).
9. The method of using a heart valve test fixture of claim 8, further comprising step (3): and placing the assembled heart valve test fixture and the heart valve (4) into a connecting pipeline, wherein the port joints at two sides of the connecting pipeline are connected with a valve in-vitro fluid dynamic test device, so that the in-vitro performance test of the heart valve can be carried out.
10. The method of using a heart valve test fixture of claim 9, wherein the connection conduit comprises a first connection tube (51), a second connection tube (52); the first connecting pipe (51) and the second connecting pipe (52) are in flange connection; the connecting ends of the first connecting pipe (51) and the second connecting pipe (52) are respectively provided with an internal buckling position, the outer side ring of the flange (12) is placed at the internal buckling position, and the first connecting pipe (51) and the second connecting pipe (52) are fixedly assembled through the flange.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110216853.9A CN112773567A (en) | 2021-02-26 | 2021-02-26 | Heart valve test fixture and use method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110216853.9A CN112773567A (en) | 2021-02-26 | 2021-02-26 | Heart valve test fixture and use method thereof |
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|---|---|
| CN112773567A true CN112773567A (en) | 2021-05-11 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202110216853.9A Pending CN112773567A (en) | 2021-02-26 | 2021-02-26 | Heart valve test fixture and use method thereof |
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| US5406857A (en) * | 1992-07-09 | 1995-04-18 | Medtronic, Inc. | Method and apparatus for testing of circumferentially compliant bioprosthetic valve |
| CN1244107A (en) * | 1997-01-24 | 2000-02-09 | 奥特克欧洲有限公司 | Heart valve prosthesis |
| US20030125804A1 (en) * | 2001-12-28 | 2003-07-03 | Kruse Steven D. | Fatigue test for prosthetic stent |
| CN103536377A (en) * | 2012-07-17 | 2014-01-29 | 李莉 | Heart bioprosthetic valve with valve leaflet capable of being repeatedly replaced through minimally invasive surgery |
| CN105578993A (en) * | 2014-06-20 | 2016-05-11 | 爱德华兹生命科学公司 | Surgical heart valves identifiable post-implant |
| CN106535825A (en) * | 2014-06-17 | 2017-03-22 | 国家研究会议 | A process of manufacturing a heart valve made of a polymeric material and the heart valve thereby obtained |
| CN110538003A (en) * | 2019-08-30 | 2019-12-06 | 宁波健世生物科技有限公司 | Heart valve opening and closing detector |
| CN111982667A (en) * | 2020-08-17 | 2020-11-24 | 四川大学 | Heart valve clamp |
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2021
- 2021-02-26 CN CN202110216853.9A patent/CN112773567A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5406857A (en) * | 1992-07-09 | 1995-04-18 | Medtronic, Inc. | Method and apparatus for testing of circumferentially compliant bioprosthetic valve |
| CN1244107A (en) * | 1997-01-24 | 2000-02-09 | 奥特克欧洲有限公司 | Heart valve prosthesis |
| US20030125804A1 (en) * | 2001-12-28 | 2003-07-03 | Kruse Steven D. | Fatigue test for prosthetic stent |
| CN103536377A (en) * | 2012-07-17 | 2014-01-29 | 李莉 | Heart bioprosthetic valve with valve leaflet capable of being repeatedly replaced through minimally invasive surgery |
| CN106535825A (en) * | 2014-06-17 | 2017-03-22 | 国家研究会议 | A process of manufacturing a heart valve made of a polymeric material and the heart valve thereby obtained |
| CN105578993A (en) * | 2014-06-20 | 2016-05-11 | 爱德华兹生命科学公司 | Surgical heart valves identifiable post-implant |
| CN110538003A (en) * | 2019-08-30 | 2019-12-06 | 宁波健世生物科技有限公司 | Heart valve opening and closing detector |
| CN111982667A (en) * | 2020-08-17 | 2020-11-24 | 四川大学 | Heart valve clamp |
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