CN104502085B - Testing device for fatigue property of medical self-expanding non-vascular lumen stent - Google Patents
Testing device for fatigue property of medical self-expanding non-vascular lumen stent Download PDFInfo
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- CN104502085B CN104502085B CN201410796590.3A CN201410796590A CN104502085B CN 104502085 B CN104502085 B CN 104502085B CN 201410796590 A CN201410796590 A CN 201410796590A CN 104502085 B CN104502085 B CN 104502085B
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Abstract
The invention provides a testing device for fatigue property of a medical self-expanding non-vascular lumen stent. The testing device comprises a sensing device and an executive device; the sensing device is used for measuring the working condition of the executive device; the executive device comprises a drive part, a transmission part and a tail end contact part; the drive part comprises an adjustable-speed motor, a speed reducer and an assembled crankshaft which are connected in sequence; the transmission part comprises connecting rods and sliding bar pairs respectively connected with the ends of the connecting rods; the other end of each sliding bar pair is connected to a connecting plate; the connecting plates are connected with the tail end contact part; the tail end contact part comprises a thermostatic water bath, moving pressure heads and fixed pressure heads, wherein the moving pressure heads are connected with the connecting plates, and the fixed pressure heads are fitted with the moving pressure heads; the moving pressure heads and the fixed pressure heads are located in the thermostatic water bath; the connecting rods are pushed periodically during the rotating process of the assembled crankshaft, so that the sliding bar pairs do reciprocating motion.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, particularly a kind of medical self-expanding non-vascular orifice bracket fatigue properties test
Device.
Background technology
For the most patient for occurring tumor or other pathological changes in the non-vascular tract such as esophagus, intestinal, biliary tract, getting up early symptom
Not substantially, the chance of surgical radical treatment has often been lost when late finding, for this kind of patient actively takes palliative treatment, has been connect
Tactile tract obstruction so as to recover unimpeded, is most important remedy measures, and at present, stent endoprosthesis are for raising patient's
Quality of life, extend the life of patient, be a kind of preferable palliative therapy method.
To the various Self-expanded stents for body cavities, its function is to expand the benign or evil caused because of pathological changes or wound
Property Stenosis, such as esophagus, biliary tract, intestinal and blood vessel etc., the diameter of this support are bigger than target tract, compress and are put into
In induction system, it is transported at lesion locations and discharges, support self-expands into preset diameters, after stenter to implant human body, produces and continue
The radial expansion force of fusion, acts on tract inwall, narrow positions is progressively expanded and is recovered unobstructed, due to Self-expanded stent
Typically there is super-elasticity, the wriggling of tract can be obedient to, so as to keep tract unobstructed and without too many sense of discomfort, support is used as long in vivo
Phase implant, which will necessarily be subject to the continuous action of environment, and such as acid or alkali environment, periodically with the effect of acyclic load, people
Special state of body tube chamber etc., in order to evaluate the safety of support product, it is necessary to consider its fatigue life.
Studying its fatigue life must take into specific internal milieu residing for support, and intravascular stent is relative due to its operating mode
Simply, individual variation is little, and grinding for effect suffered after the function and implantation reached required for intravascular stent
Study carefully many also very detailed, U.S. FDA has made the standard of fatigue test, is wherein distinctly claimed in the test of its fatigue test
The dependency of method and its external time and internal time, but to other self expandable orifice brackets is more due to stent size
The complexity that sample and tract are wriggled, the unified standard or test equipment for still not having correlation, is carried out to self expandable orifice bracket
The experiment in vitro of fatigue life is to ensure the safe and reliable work of non-vessel stent and subsequently optimize the necessary means being related to again, therefore
It is necessary to the fatigue property test of self expandable orifice bracket.The fatigue test of intravascular stent should be including 400,000,000 cycles (quite
In 10 years) experiment in vitro, and need the patient for being implanted into self expandable orifice bracket mostly to be late malignant tumour when being found in vivo,
Survival period is short.The wriggling of different tracts is period of wave different, therefore not can determine that unified fatigue period, therefore at present to self expandable chamber
The fatigue property test of road support is mainly to determine its peristalsises number of times for bearing, the i.e. fatigue period of support.
It is big for the change in size scope of various self expandable tracts, peripheral vascular stents, diameter range 6-30mm, length model
Enclose 40-180mm, it is clear that the excursion of diameter and length is all very big, therefore the key of test device is suitable various sizes of
The peristalsises effect of support and simulation tract, in the situation that various orifice bracket area researches are deficient, this expands certainly both at home and abroad
Open orifice bracket fatigue property test device and adopt compacted dynamic load effect of the various tracts of compound cam mechanism analog to support, and
And the true pipe that this self expandable orifice bracket fatigue property test device is born after full simulation stenter to implant human body as far as possible
In the case of wall wriggling environment, rupturing and measuring automatically the tired all of support based on pressure feedback technology real-time detection support
Phase.
The content of the invention
Goal of the invention：The technical problem to be solved is for the deficiencies in the prior art, there is provided one kind is medical certainly
Expansion non-vascular orifice bracket fatigue characteristic testing device.
In order to solve above-mentioned technical problem, the invention discloses a kind of medical self-expanding non-vascular orifice bracket fatigue properties
Test device, including sensing device and performs device, the sensing device is used for measuring the working condition of performs device；It is described to hold
Luggage is put including drive part, running part and end contact part, buncher that the drive part includes being sequentially connected,
Decelerator and built-up crankshaft, the slide bar pair that the running part is included connecting rod and is connected with connecting rod one end；The slide bar pair
The other end is connected to connecting plate, and the connecting plate connects end contact part, and end contact part includes constant temperature water bath and connects
The mobile pressure head of fishplate bar connection, and the fixed pressure head being adapted to mobile pressure head；The mobile pressure head and fixed pressure head are located at perseverance
In warm water bath；Built-up crankshaft promotes connecting rod in rotary course, periodically so that slide bar is secondary to be moved back and forth.
In the present invention, the mobile pressure head be one group of spaced semicircular ring, be provided with the fixed pressure head with it is described
The recess of spaced semicircular ring adaptation.
In the present invention, the fixed pressure head is removable semicircular ring with mobile pressure head.
In the present invention, the sensing device includes the spin counter for measuring buncher, and is arranged on slide bar
Pressure transducer between secondary and connecting plate.
In the present invention, the slide bar is secondary and connecting plate junction is higher than mobile pressure head and the junction of connecting plate.
In the present invention, in water bath, simulated body fluid can be put, such as simulated gastric fluid, model bile, simulated body fluid etc., so
Actual condition can be more fed back just.
Beneficial effect：This stent fatigue performance testing device, by operating the design for processing that software controls performs device, leads to
Cross pressure head and fix tested support, simulate tract and the long-duration load of support is acted on, apply annular radial systolic pressure, electricity to support
Machine is simulated tract and the periodicity wriggling of support is carried by the compound cam mechanism of decelerator driving relative misalignment certain angle
Lotus acts on, and the device is suitable for the fatigue property test of multiple diameter scope support, by sensing detection technology, gathers in real time
With the bounce of fatigue analysis test process medium-height trestle, judge whether support has fracture of wire situation, and then according to cycle during fracture
Count to assess self expandable orifice bracket fatigue behaviour, the device can effectively simulate the complicated wriggling of tract, and have fast
The advantages of speed, reliability, digitized and automatization, the fatigue behaviour of support is analyzed using the device, support can be optimized
Design.
Description of the drawings
With reference to the accompanying drawings and detailed description the present invention is done and is further illustrated, the present invention it is above-mentioned or
Otherwise advantage will become apparent.
Fig. 1 is the structural representation of performs device of the present invention.
Specific embodiment
The present invention is elaborated below in conjunction with accompanying drawing.
As shown in figure 1, the present invention includes sensing device and performs device, the sensing device is used for measuring performs device
Working condition；Performs device includes drive part 1, running part 2, end contact part 3 and tested support 10, wherein, drives
Part 1 includes buncher 4, decelerator 5 and the built-up crankshaft 6 being sequentially connected, and includes connecting rod 7, connecting rod 7 on running part 2
One end connects built-up crankshaft 6, and other end connection slide bar pair 8,8 ends of slide bar pair are provided with pressure transducer 13, and rear end is accessed and connected
Fishplate bar 9,9 another side bottom of connecting plate connection mobile pressure head 12, in end contact part 3 include constant temperature water bath 14, and connection
The mobile pressure head 12 of plate connection, the fixed pressure head 11 being adapted to mobile pressure head 12, fixed pressure head 11 are half with mobile pressure head 12
Cirque structure and fixed pressure head 11 is provided with the recess being adapted to mobile pressure head 12, when built-up crankshaft 6 is rotated, can pass through
The promotion of connecting rod 7, slide bar secondary 8 and connecting plate 9, mobile pressure head 12 is advanced in the recess of fixed pressure head 11.
The end contact part of this stent fatigue performance testing device is made up of one group of paired pressure head arranged in parallel, pressure head
Matching can be changed according to various sizes of support, simulate long-term annular radial systolic pressure of the tract to support.Drive
Part includes built-up crankshaft, buncher and decelerator, and built-up crankshaft is by one group along the axial certain angle of mutually staggering of support
Camshaft and corresponding push rod composition that the cam of degree is constituted.Pressure transducer is arranged on each push rod.By designing cam wheel
Wide and mutual phase place, it is possible to achieve any wriggling rule load of simulation.The change of temperature has notable shadow to the elastic characteristic of support
Ring, be the fatigue behaviour for ensureing accurate test bracket, end contact part is placed in constant temperature water bath, temperature accuracy can reach
±0.5℃。
In the present invention, the design of symmetric double semi arch indenter device and thermostat water bath of the surface with silicone rubber can
Contact situation of the non-vascular tract with support is simulated to greatest extent；Symmetrical double semi arch indenter devices, can be adapted to difference
The support of size.Also can be by double semi arch indenter devices of replacing different radii so that higher with the matching of support.
In water bath, simulated body fluid can be put, such as simulated gastric fluid, model bile, simulated body fluid etc., thus more can be anti-
Feedback actual condition.
The control system of this stent fatigue performance testing device, is processed comprising a high-performance PC, interface card and operation
Software, it is the Digital Signals output and real-time data acquisition program write based on LabVIEW platform that operation processes software, should
Program has interactive interface, not only provides control signal to interface card, and the signal detected by sensing device is carried out
Collection analysises, judge the fracture of wire situation of identification support, draw the fatigue period of support；This stent fatigue performance testing device connects
Mouth card, the digital signal that PC is exported is changed, and by control signal output to performs device；This stent fatigue performance is surveyed
The sensing device that trial assembly is put, comprising spin counter and array of pressure sensors.The buncher of grating belt encoder can be straight
The number of times of compression motion when calculating cradling function timeliness is connect, the rotating speed and revolution of motor, when support is shunk under load effect
Bounce, corresponding signal can be detected by sensing device, feed back to operation process software processes.
The present invention when in use, first chooses to install suitable pressure head according to the size of tested support, tested support is fixed on
On loading pressure head, the wriggling rule (wriggling waveform and wavelength) according to needed for test selects cam set and constant phase angle, leads to
Control system setting wriggling wave velocity is crossed, control system sends control signals to interface card, and interface card is exported after signal is changed
To drive part, drive part band dynamic head moves reciprocatingly, and realizes that the load to support is acted on, in test process, by end
Contact portion is placed in constant temperature water bath, the rotating speed and revolution of spin counter real-time detection motor, array of pressure sensors reality
When detect pressure size, detection signal feeds back to control system by interface card, by operation process software to tach signal and pressure
Force signal is analyzed, and judges whether support occurs fatigue fracture, draws the fatigue period of support.
The present invention when in use, can be by the relative deflection angle of the independent bent axle unit of setting, so as to change compression motion
Rule, to adapt to the wriggling rule of different non-vascular tracts.Can also be in same blood vessel tract, by changing compression motion rule
Rule, to investigate impact of the different wriggling rules to support.
The invention provides a kind of medical self-expanding non-vascular orifice bracket fatigue characteristic testing device, implements the skill
The method and approach of art scheme is a lot, and the above is only the preferred embodiment of the present invention, it is noted that for this technology is led
For the those of ordinary skill in domain, under the premise without departing from the principles of the invention, some improvements and modifications can also be made, these
Improvements and modifications also should be regarded as protection scope of the present invention.In the present embodiment, clearly each ingredient not can use prior art
Realized.
Claims (4)
1. a kind of medical self-expanding non-vascular orifice bracket fatigue characteristic testing device, it is characterised in that including sensing device and
Performs device, the sensing device are used for measuring the working condition of performs device；
The performs device includes drive part (1), running part (2) and end contact part (3), drive part (1)
Including the buncher (4), decelerator (5) and built-up crankshaft (6) that are sequentially connected, described running part (2) include connecting rod (7)
And slide bar pair (8) being connected with connecting rod (7) one end；Described slide bar pair (8) other end is connected to connecting plate (9), the connection
Plate (9) connection end contact part (3), end contact part (3) include constant temperature water bath (14), and connecting plate (9) connect
Mobile pressure head (12), and the fixed pressure head (11) being adapted to mobile pressure head (12)；Mobile pressure head (12) and fixed pressure head
(11) it is located in constant temperature water bath (14)；
Built-up crankshaft (6) promotes connecting rod (7) in rotary course, periodically so that slide bar pair (8) is moved back and forth；It is described
Mobile pressure head (12) is to be provided with and the spaced semicircle in one group of spaced semicircular ring, fixed pressure head (11)
The recess of ring adaptation.
2. a kind of medical self-expanding non-vascular orifice bracket fatigue characteristic testing device according to claim 1, its feature
It is that fixed pressure head (11) are removable semicircular ring with mobile pressure head (12).
3. a kind of medical self-expanding non-vascular orifice bracket fatigue characteristic testing device according to claim 1, its feature
It is that the sensing device includes the spin counter for measuring buncher (4), and is arranged on slide bar pair (8) and connects
Pressure transducer (13) between fishplate bar (9).
4. a kind of medical self-expanding non-vascular orifice bracket fatigue characteristic testing device according to claim 1, its feature
It is that slide bar pair (8) is with connecting plate (9) junction higher than mobile pressure head (12) and the junction of connecting plate (9).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410796590.3A CN104502085B (en) | 2014-12-18 | 2014-12-18 | Testing device for fatigue property of medical self-expanding non-vascular lumen stent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410796590.3A CN104502085B (en) | 2014-12-18 | 2014-12-18 | Testing device for fatigue property of medical self-expanding non-vascular lumen stent |
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| Publication Number | Publication Date |
|---|---|
| CN104502085A CN104502085A (en) | 2015-04-08 |
| CN104502085B true CN104502085B (en) | 2017-03-22 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410796590.3A Active CN104502085B (en) | 2014-12-18 | 2014-12-18 | Testing device for fatigue property of medical self-expanding non-vascular lumen stent |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108955990B (en) * | 2018-04-19 | 2020-12-11 | 东南大学 | Experimental device for radial holding power of vascular support in real-time supervision simulation environment |
| CN110749435B (en) * | 2019-11-28 | 2021-05-18 | 江苏理工学院 | Testing arrangement of vascular support bending property |
Citations (5)
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| CN1739463A (en) * | 2005-06-29 | 2006-03-01 | 东南大学 | Extracorporeal test device and method for the dilation performance of saccule dilating intravascular rack |
| CN201517966U (en) * | 2009-08-08 | 2010-06-30 | 黄研昕 | Guy cable type radial force performance measuring device for medical inner support product |
| CN103604596A (en) * | 2013-12-02 | 2014-02-26 | 南京林业大学 | Extracorporeal testing device of fatigue performance of woven-type non-vessel support |
| CN103645038A (en) * | 2013-11-25 | 2014-03-19 | 北京垠海工程技术研究有限责任公司 | Bracket fatigue testing machine |
| CN204694453U (en) * | 2014-12-18 | 2015-10-07 | 南京微创医学科技有限公司 | Medical self-expanding non-vascular orifice bracket fatigue characteristic testing device |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6810751B2 (en) * | 2002-07-29 | 2004-11-02 | Michael R. Moreno | Method and apparatus for vascular durability and fatigue testing |
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2014
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|---|---|---|---|---|
| CN1739463A (en) * | 2005-06-29 | 2006-03-01 | 东南大学 | Extracorporeal test device and method for the dilation performance of saccule dilating intravascular rack |
| CN201517966U (en) * | 2009-08-08 | 2010-06-30 | 黄研昕 | Guy cable type radial force performance measuring device for medical inner support product |
| CN103645038A (en) * | 2013-11-25 | 2014-03-19 | 北京垠海工程技术研究有限责任公司 | Bracket fatigue testing machine |
| CN103604596A (en) * | 2013-12-02 | 2014-02-26 | 南京林业大学 | Extracorporeal testing device of fatigue performance of woven-type non-vessel support |
| CN204694453U (en) * | 2014-12-18 | 2015-10-07 | 南京微创医学科技有限公司 | Medical self-expanding non-vascular orifice bracket fatigue characteristic testing device |
Non-Patent Citations (1)
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| 基于有限元仿真的食管支架疲劳寿命计算;倪晓宇等;《东南大学学报》;20090930;第39卷(第5期);第921页 * |
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Address after: 210061 hi tech Industrial Development Zone, Pukou District, Jiangsu, hi tech Road, No. three, No. 10, No. Applicant after: MICRO-TECH (NANJING) CO., LTD. Address before: 210061 hi tech Industrial Development Zone, Pukou District, Jiangsu, hi tech Road, No. three, No. 10, No. Applicant before: Nanjing Micro-Tech Co., Ltd. |
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Address after: 210061, No. 10, hi tech three road, Pukou hi tech Industrial Development Zone, Nanjing, Jiangsu Patentee after: Nanwei Medical Technology Co., Ltd Address before: 210061, No. 10, hi tech three road, Pukou hi tech Industrial Development Zone, Nanjing, Jiangsu Patentee before: Micro-Tech (Nanjing) Co., Ltd. |
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