CN112666017A - Evaluation device and method for film-covering strength in esophagus film-covered stent - Google Patents
Evaluation device and method for film-covering strength in esophagus film-covered stent Download PDFInfo
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- CN112666017A CN112666017A CN202110030481.0A CN202110030481A CN112666017A CN 112666017 A CN112666017 A CN 112666017A CN 202110030481 A CN202110030481 A CN 202110030481A CN 112666017 A CN112666017 A CN 112666017A
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Abstract
The invention discloses an evaluation device and method for the film-coating strength in an esophagus covered stent, wherein the evaluation device comprises a test frame, a covered stent fixing part, a test part and a control part, the covered stent fixing part is used for fixing the covered stent, and the covered stent fixing part is arranged on the test frame; the testing part comprises a testing head and a driving part which drives the testing head to reciprocate towards the fixing part of the film coating bracket, and the testing head is connected with the driving part; the control part is connected with the driving part to control the test head. The evaluation device and the evaluation method provided by the invention simulate the clinical practical application scene of the esophageal stent graft, the test result can objectively, scientifically and accurately reflect the practical strength of the stent graft, and an objective, quantitative and qualitative basis is provided for comparing the performance of the stent graft of different products.
Description
Technical Field
The invention relates to the technical field of covered stents, in particular to a device and a method for evaluating the strength of a covered membrane in an esophagus covered stent.
Background
The covered stent is an important medical appliance for treating diseases such as stenosis, slight occlusion, aneurysm and the like of a pipeline organ, the esophagus covered stent is a typical product of the covered stent of a non-vascular pipeline organ, and the most common esophagus covered stent at present is a manually woven stent covered by a silica gel film.
The clinical application practice of the esophagus covered stent shows that the covering membrane is easy to damage to cause the graft failure. Common causes of damage to the cover include adhesion of the silicone membrane, incomplete or uneven vulcanization, and eating.
However, there is no corresponding standard and standardized method for evaluating the strength of the membrane in the esophageal stent graft, and there is no relevant instrument for testing the strength of the membrane in the stent graft. This presents great difficulties in evaluating the strength of the coating in a stent graft. The lack of evaluation of the film covering strength brings huge risks to the clinical application of products, and also brings inconvenience to the development of new products and the comparison of different product qualities.
Therefore, the above prior art has at least the following technical problems: in the prior art, a device and a method for evaluating the strength of a covering film in an esophagus covering film stent are lacked.
Disclosure of Invention
The embodiment of the application solves the technical problem that the evaluation device and method for the film strength in the esophagus covered stent are lacked in the prior art by providing the evaluation device and method for the film strength in the esophagus covered stent.
In order to solve the above problem, in a first aspect, an embodiment of the present application provides an evaluation device for evaluating strength of a stent graft in an esophagus stent graft, the evaluation device including:
a test jig;
the covered stent fixing part is used for fixing the covered stent and is arranged on the test rack;
the testing part comprises a testing head and a driving part which drives the testing head to reciprocate towards the direction of the fixed part of the film coating bracket, and the testing head is connected with the driving part;
and the control part is connected with the driving part to control the test head.
Further, the test jig include the base, tectorial membrane support fixed part include:
the lower chuck is fixed on the base to fix the bottom of the film coating bracket;
and the upper chuck is fixed on the test frame and positioned above the lower chuck so as to fix the top of the film coating support.
Further, the test section further includes:
the moving piece is arranged in the test rack in a vertically sliding manner and is connected with the driving piece;
the top end of the connecting rod is fixed on the lower surface of the moving part, the bottom end of the connecting rod is fixedly connected with the testing head, and the testing head is positioned right above the lower chuck;
the force sensor is fixed between the moving piece and the connecting rod and is connected with the controller.
Furthermore, the driving part is a hydraulic cylinder, and the outer end of a piston rod of the hydraulic cylinder is fixedly connected with the moving part so as to drive the moving part to move up and down.
Further, the test head is a sphere.
Further, the test head includes but is not limited to stainless steel ball, copper ball, plastic ball, glass ball, rubber ball.
Furthermore, the test head is detachably connected with the connecting rod, so that the test head can be replaced conveniently.
In a second aspect, the present application further provides a method for evaluating the strength of a stent graft in an esophageal stent graft, the method including the following steps:
fixing the lower end of the covered stent on the base through the lower chuck, and enabling the covered stent to be in a vertical state;
mounting the test head on the connecting rod, and enabling the test head to enter a test part in the film covering bracket;
fixing the upper end of the covered stent on the test frame through the upper chuck;
setting a test range and a test frequency through the controller, starting a test, and controlling the test head to move in the film covering bracket according to the test range and the test frequency through the controller;
when the covering film begins to be damaged, the test is stopped, and the covering film strength of the covered stent is evaluated based on the test conditions and the test times recorded by the controller.
Further, the test conditions include the test range, the test frequency, the diameter ratio of the test head to the film coating bracket, and the material of the test head.
Further, the test range refers to the distance of the test head moving up and down in the film coating support, and the test range is 1-10 cm; the test frequency refers to the frequency of the test head moving up and down in the film coating support, and is 1-50 Hz; the diameter ratio ranges from 1.01 to 1.25: 1.
One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:
(1) the evaluation device is arranged to evaluate the strength of the membrane in the esophageal stent graft, the evaluation device comprises a stent graft fixing part for fixing the stent graft and a testing part for testing the strength of the membrane, the testing part comprises a testing head and a driving part for driving the testing head to reciprocate towards the direction of the stent graft fixing part, and the driving part drives the testing head to reciprocate in the stent graft under the control of the controller according to a preset test condition so as to simulate the clinical practical application scene of the esophageal stent graft; the method has the advantages that the film covering strength of the covering film is evaluated based on the test condition and the film covering condition after the test is finished, the technical problem that an evaluation device and method for the film covering strength in the esophagus covering stent are lacked in the prior art is solved, and the beneficial effects of simple structure, wide application range, objective test result and good repeatability are achieved.
(2) The embodiment of the application directly evaluates the film coating strength of the covered stent by arranging the evaluation device and the evaluation method, has higher accuracy, and overcomes the defect that the performance evaluation of a substitute product (covered stent) is evaluated by the performance evaluation of a material (film coating material) in the prior art.
(3) The evaluation device and the evaluation method simulate the clinical practical application scene of the esophageal stent graft, the test result can objectively, scientifically and accurately reflect the practical strength of the stent graft, and objective, quantitative and qualitative basis is provided for comparing the performance of the stent graft of different products.
(4) The upper clamping head can clamp the clamping ring at the top of the film covering support, and the clamping ring is convenient to open and close and is fixed firmly.
(5) The test head in this application embodiment with connecting rod detachably connect, so that change the test head.
(6) The utility model provides an elasticity card post with card hole buckle cooperation, insert the bottom of connecting rod in the jack, card post card is gone into in the card hole, can prevent the test head with the connecting rod separation.
Drawings
FIG. 1 is a schematic structural diagram of an apparatus for evaluating the strength of a stent graft in an esophagus according to an embodiment of the present application;
FIG. 2 is a schematic flow chart illustrating a method for evaluating the strength of a stent graft in an esophagus according to an embodiment of the present disclosure;
FIG. 3 is a graphical representation of the strength of the stent graft versus the diameter of the balloon of an integrated stent graft according to an embodiment of the present application;
FIG. 4 is a schematic diagram illustrating the relationship between the material of the test head and the strength of the stent graft of the integrated stent graft when the diameter of the ball is 9.3mm in one embodiment of the present disclosure;
FIG. 5 is a schematic diagram illustrating a relationship between a material of a test head and a film strength of a PU film-covered stent when a diameter of a ball is 9.3mm in an embodiment of the present application;
FIG. 6 is a schematic diagram illustrating a relationship between a material of a test head and a coating strength of a silica gel stent graft when a diameter of a ball is 9.3mm in an embodiment of the present application.
Detailed Description
The embodiment of the application solves the technical problem that the evaluation device and method for the film strength in the esophagus covered stent are lacked in the prior art by providing the evaluation device and method for the film strength in the esophagus covered stent.
In order to solve the technical problems, the general idea of the embodiment of the application is as follows: the evaluation device is arranged for evaluating the strength of a film in the esophageal stent graft, the evaluation device comprises a stent graft fixing part for fixing the stent graft and a testing part for testing the strength of the film, the testing part comprises a testing head and a driving part for driving the testing head to reciprocate towards the direction of the stent graft fixing part, and the driving part drives the testing head to reciprocate in the stent graft under the control of the controller according to preset testing conditions so as to simulate the clinical practical application scene of the esophageal stent graft; the method has the advantages that the film covering strength of the covering film is evaluated based on the test conditions and the film covering condition after the test is finished, the technical problem that an evaluation device and method for the film covering strength in the esophagus covering stent are lacked in the prior art is solved, and the beneficial effects of simple structure, wide application range, objective test result and good repeatability are achieved.
In order to better understand the technical solution, the technical solution will be described in detail with reference to the drawings and the specific embodiments.
Example one
FIG. 1 is a schematic structural diagram of an evaluation device for the strength of a stent graft in an esophageal stent graft according to an embodiment of the present application, and the evaluation device includes a test frame 21, a stent graft fixing portion, a test portion and a control portion 29, as shown in FIG. 1.
The two sides of the test frame 21 are provided with side walls vertically arranged along the up-down direction. The covered stent fixing part is used for fixing the covered stent 10, and the covered stent fixing part is arranged at the lower part of the test jig 21.
The testing part is located directly over the tectorial membrane support fixed part, just the testing part includes test head 25 and drive test head 25 to tectorial membrane support fixed part direction reciprocating motion's driving piece, just test head 25 with the driving piece links to each other. Specifically, the driving member may drive the test head 25 to reciprocate up and down.
The control section 29 is connected to the drive member to control the test head 25 to move according to a predetermined trajectory and frequency. Specifically, in this embodiment, the control unit 29 is a computer in which a control program is provided, and the control unit 29 can control the movement direction, the movement frequency, the movement distance, and the like of the test head 25 by controlling the driving member.
The evaluation device is arranged to evaluate the strength of the membrane in the esophageal stent graft, the evaluation device comprises a stent graft fixing part for fixing the stent graft 10 and a testing part for testing the strength of the membrane, the testing part comprises a testing head 25 and a driving part for driving the testing head 25 to reciprocate towards the direction of the stent graft fixing part, and the driving part drives the testing head to reciprocate in the stent graft under the control of the controller 29 according to preset testing conditions so as to simulate the clinical practical application scene of the esophageal stent graft; the method has the advantages that the film covering strength of the covering film is evaluated based on the test condition and the film covering condition after the test is finished, the technical problem that an evaluation device and method for the film covering strength in the esophagus covering stent are lacked in the prior art is solved, and the beneficial effects of simple structure, wide application range, objective test result and good repeatability are achieved.
Further, the testing jig 21 includes a base 22, the stent graft fixing portion includes a lower chuck 23 and an upper chuck 24 for vertically fixing the stent graft 10, the upper chuck 23 and the lower chuck 24 are aligned up and down, and in this embodiment, the upper chuck and the lower chuck 24 are coaxially disposed up and down. The lower clamping head 23 is fixed on the base 22 to fix the bottom of the film covering bracket 10; the upper clamp 24 is fixed on the test frame 21 to fix the top of the stent graft 10.
Specifically, in this embodiment, the lower clamp 23 is a groove fixed on the base 22, and the bottom of the stent graft 10 is inserted into the groove and fixed on the base 22; the upper chuck 24 is a clamping ring capable of clamping the top of the covered stent 10, the clamping ring comprises two clamping flaps, the fixed ends of the two clamping flaps are hinged, the free ends of the two clamping flaps are occluded, and the top of the covered stent 10 can be sleeved with the clamping flaps; the fixed ends are pinched, the free ends of the clamping flaps are mutually separated, and the covered stent 10 can be taken out; and one side of the clamping ring is fixed on the inner side wall of the test frame 21 through a rod piece, and the clamping ring is convenient to open and close and is fixed firmly.
Further, the test section includes a moving member 28, a connecting rod 26, and a force sensor 27 in addition to the test head 25 and the driving member. The moving member 28 is disposed in the testing jig 21 in a vertically slidable manner, and the moving member 28 is connected to the driving member, in this embodiment, the moving member 28 is a rod body with two ends capable of sliding along the side wall of the testing jig 21, for example, a sliding slot extending vertically is disposed on the side wall of the testing jig 21, and two ends of the moving member 28 are slidably inserted into the sliding slot.
The top end of the connecting rod 26 is fixed on the lower surface of the moving part 28, the bottom end of the connecting rod 26 is fixedly connected with the test head 25, and the test head 25 is positioned right above the lower chuck 24;
the force sensor 27 is fixed between the moving part 28 and the connecting rod 26, the force sensor 27 is connected with the controller 29, the force sensor 27 collects the force fed back by the testing head 25 to reflect the friction force applied to the film in the testing process, and transmits the friction force to the controller for storage and display, and the friction force can reflect the testing conditions of the film.
Further, the driving member is a hydraulic cylinder, and the outer end of the piston rod of the hydraulic cylinder is fixedly connected with the moving member 28 to drive the moving member 28 to move up and down. Specifically, the piston rod of the hydraulic cylinder is arranged along the vertical direction, the moving member 28 can be driven to move up and down, and the controller 29 is connected with the hydraulic cylinder so as to control the expansion, movement frequency and movement distance of the hydraulic cylinder.
Further, the test head 25 is a sphere. And the test head comprises but is not limited to stainless steel balls, copper balls, plastic balls, glass balls and rubber balls, and the test results of the coated film are different by the balls made of different materials.
Further, the diameter of the test head 25 ranges from 16 mm to 39 mm.
Further, the test head 25 is detachably connected to the connection rod 26, so that the test head 25 can be easily replaced. For example, the test head 25 on seted up the jack, the bottom of connecting rod 26 can be inserted in the jack, the lateral wall of jack is equipped with the card hole, be equipped with the elasticity card post that extends to both sides on the side of connecting rod 26 bottom, elasticity card post with card hole snap-fit, the bottom of connecting rod 26 is inserted in the jack, card post card is gone into in the card hole, in order to prevent the test head 25 with connecting rod 26 separate.
Example two
Based on the same inventive concept as the evaluation device for the strength of the membrane in the esophageal stent graft in the first embodiment, the invention also provides an evaluation method for the strength of the membrane in the esophageal stent graft, which comprises the following steps:
step 110: fixing the lower end of the covered stent 10 on the base 22 through the lower chuck 23, and enabling the covered stent 10 to be in a vertical state;
step 120: mounting the test head 25 on the connecting rod 26 and allowing the test head 25 to enter a test site in the stent graft 10;
step 130: fixing the upper end of the covered stent 10 on the test frame 21 through the upper chuck 24;
step 140: setting a test range and a test frequency through the controller 29, starting a test, controlling the driving part to drive the moving part 28 to move downwards by the controller, and enabling the test head 25 to move in the covered stent 10 according to the test range and the test frequency;
specifically, the distances between the test part of the covered stent 10 and the parts of the lower chuck 23 and the upper chuck 24 are both more than 10 mm.
Specifically, the controller 29 is a computer, the controller 29 is connected to an input device (keyboard), and the controller 29 can control the driving member, i.e., the test head 25, according to the test range and the test frequency by inputting the preset test range and the test frequency on the input device.
Further, the test range refers to the distance of the test head 25 moving up and down in the film coating support 10, and the test range is 1-10 cm; the test frequency refers to the frequency of the test head 25 moving up and down in the film coating support 10, and the test frequency is 1-50 Hz.
Step 150: when the membrane starts to be damaged, the test is stopped, the test head 25 stops moving, the upper chuck 24 is unloaded, the test head 25 is withdrawn, the covered stent 10 is taken out from the lower chuck 23, the structural form change of the membrane is observed, and the membrane strength of the covered stent is evaluated based on the test conditions and the test times recorded by the controller.
Specifically, the test frequency refers to the frequency of the up-and-down reciprocating movement of the test head 25 in the stent graft 10 when the stent graft is damaged.
Further, the test conditions include the test range, the test frequency, the diameter ratio of the test head to the stent graft 10, and the material of the test head 25.
Specifically, the film strength is defined as the number of times of the test when the film is broken under a certain test condition.
Further, the diameter ratio ranges from 1.01 to 1.25: 1.
Under the fixed condition that the test range is 1.5cm and the test frequency is 1Hz, the tectorial membrane stent with the length of 7cm and the inner diameter of 9mm is selected for evaluation of tectorial membrane strength, and the specific results are shown in Table 1.
TABLE 1 film-covered Stent Strength test results
The relationship between the strength of the coating and the diameter of the ball (diameter of the test head) of the integrated stent graft obtained from the above table 1 is shown in FIG. 3; when the diameter of the ball is 9.3mm, the relation between the material of the test head and the film-coating strength of the integrated film-coated stent is shown in figure 4; when the diameter of the ball is 9.3mm, the relation between the material of the test head and the film-coating strength of the PU film-coated stent is shown in figure 5; the relationship between the material of the test head and the film strength of the silica gel covered stent is shown in FIG. 6 when the diameter of the ball is 9.3 mm.
The evaluation device provided by the embodiment of the application is used for evaluating the strength of the coating film in the esophagus coated stent according to the evaluation method provided by the embodiment of the application, and the clinical practical application scene of the esophagus coated stent is simulated, so that the test result can objectively, scientifically and accurately reflect the actual strength of the coating film, and an objective, quantitative and qualitative basis is provided for comparing the coating film performances of different products.
The technical scheme in the embodiment of the application at least has the following technical effects or advantages:
(1) the evaluation device is arranged to evaluate the strength of the membrane in the esophageal stent graft, the evaluation device comprises a stent graft fixing part for fixing the stent graft 10 and a testing part for testing the strength of the membrane, the testing part comprises a testing head 25 and a driving part for driving the testing head 25 to reciprocate towards the direction of the stent graft fixing part, and the driving part drives the testing head to reciprocate in the stent graft under the control of the controller 29 according to preset testing conditions so as to simulate the clinical practical application scene of the esophageal stent graft; the method has the advantages that the film covering strength of the covering film is evaluated based on the test condition and the film covering condition after the test is finished, the technical problem that an evaluation device and method for the film covering strength in the esophagus covering stent are lacked in the prior art is solved, and the beneficial effects of simple structure, wide application range, objective test result and good repeatability are achieved.
(2) The embodiment of the application directly evaluates the film coating strength of the covered stent by arranging the evaluation device and the evaluation method, has higher accuracy, and overcomes the defect that the performance evaluation of a substitute product (covered stent) is evaluated by the performance evaluation of a material (film coating material) in the prior art.
(3) The evaluation device and the evaluation method simulate the clinical practical application scene of the esophageal stent graft, the test result can objectively, scientifically and accurately reflect the practical strength of the stent graft, and objective, quantitative and qualitative basis is provided for comparing the performance of the stent graft of different products.
(4) The upper clamping head 24 of the embodiment of the application is a clamping ring which can clamp the top of the film covering bracket 10, and the clamping ring is convenient to open and close and is fixed firmly.
(5) The test head 25 according to the embodiment of the present application is detachably connected to the connecting rod 26, so that the test head 25 can be replaced.
(6) The embodiment of the application elastic clamping column with the clamping hole is in buckled fit, the bottom end of the connecting rod is inserted into the jack, the clamping column is clamped into the clamping hole, and the test head 25 can be prevented from being separated from the connecting rod 26.
It should be understood that terms of orientation such as outer, middle, inner, etc., referred to or as may be referred to in this specification are defined relative to the configuration shown in the drawings and are relative terms, such that the terms may be changed correspondingly according to the position and the use state of the terms. Therefore, these and other directional terms should not be construed as limiting terms.
While the foregoing is directed to the preferred embodiment of the present application, and not to the limiting thereof in any way and any way, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention as defined by the appended claims. Those skilled in the art can make various changes, modifications and equivalent arrangements to those skilled in the art without departing from the spirit and scope of the present application; moreover, any equivalent alterations, modifications and variations of the above-described embodiments according to the spirit and techniques of this application are intended to be within the scope of the claims of this application.
Claims (10)
1. An evaluation device for the strength of a stent graft in an esophageal stent graft, the evaluation device comprising:
a test jig;
the covered stent fixing part is used for fixing the covered stent and is arranged on the test rack;
the testing part comprises a testing head and a driving part which drives the testing head to reciprocate towards the direction of the fixed part of the film coating bracket, and the testing head is connected with the driving part;
and the control part is connected with the driving part to control the test head.
2. The device of claim 1, wherein the test frame comprises a base, and the stent graft fixing portion comprises:
the lower chuck is fixed on the base to fix the bottom of the film coating bracket;
and the upper chuck is fixed on the test frame and positioned above the lower chuck so as to fix the top of the film coating support.
3. The apparatus of claim 2, wherein the test portion further comprises:
the moving piece is arranged in the test rack in a vertically sliding manner and is connected with the driving piece;
the top end of the connecting rod is fixed on the lower surface of the moving part, the bottom end of the connecting rod is fixedly connected with the testing head, and the testing head is positioned right above the lower chuck;
the force sensor is fixed between the moving piece and the connecting rod and is connected with the controller.
4. The device for evaluating the strength of a stent graft on an esophageal stent graft of claim 3, wherein the driving member is a hydraulic cylinder, and the outer end of the piston rod of the hydraulic cylinder is fixedly connected with the moving member to drive the moving member to move up and down.
5. The device of claim 3, wherein the test head is a sphere.
6. The device as claimed in claim 5, wherein the test head includes but is not limited to stainless steel ball, copper ball, plastic ball, glass ball, rubber ball.
7. The apparatus of claim 3, wherein the test head is detachably connected to the connection rod to facilitate replacement of the test head.
8. A method for evaluating the strength of a coating in an esophagus coated stent is characterized by comprising the following steps:
fixing the lower end of the covered stent on the base through the lower chuck, and enabling the covered stent to be in a vertical state;
mounting the test head on the connecting rod, and enabling the test head to enter a test part in the film covering bracket;
fixing the upper end of the covered stent on the test frame through the upper chuck;
setting a test range and a test frequency through the controller, starting a test, and controlling the test head to move in the film covering bracket according to the test range and the test frequency through the controller;
when the covering film begins to be damaged, the test is stopped, and the covering film strength of the covered stent is evaluated based on the test conditions and the test times recorded by the controller.
9. The method of claim 8, wherein the test conditions include the test range, the test frequency, the ratio of the test head to the stent graft, and the material of the test head.
10. The method for evaluating the strength of a coating in an esophageal stent graft according to claim 9, wherein the test range is a distance of up and down movement of the test head in the stent graft, and the test range is 1-10 cm; the test frequency refers to the frequency of the test head moving up and down in the film coating support, and is 1-50 Hz; the diameter ratio ranges from 1.01 to 1.25: 1.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110030481.0A CN112666017A (en) | 2021-01-11 | 2021-01-11 | Evaluation device and method for film-covering strength in esophagus film-covered stent |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110030481.0A CN112666017A (en) | 2021-01-11 | 2021-01-11 | Evaluation device and method for film-covering strength in esophagus film-covered stent |
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| Publication Number | Publication Date |
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| CN112666017A true CN112666017A (en) | 2021-04-16 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202110030481.0A Pending CN112666017A (en) | 2021-01-11 | 2021-01-11 | Evaluation device and method for film-covering strength in esophagus film-covered stent |
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| CN (1) | CN112666017A (en) |
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2021
- 2021-01-11 CN CN202110030481.0A patent/CN112666017A/en active Pending
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