CN216771463U - Clamping device and system for membrane adhesion test of covered stent - Google Patents

Clamping device and system for membrane adhesion test of covered stent Download PDF

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CN216771463U
CN216771463U CN202120892637.1U CN202120892637U CN216771463U CN 216771463 U CN216771463 U CN 216771463U CN 202120892637 U CN202120892637 U CN 202120892637U CN 216771463 U CN216771463 U CN 216771463U
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stent
covered stent
membrane
covered
hollowed
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黄磊
程国政
陈朝辉
陆冬润
周卫超
刘俊
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Shanghai Huikai Medical Technology Co ltd
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Shanghai Huikai Medical Technology Co ltd
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Abstract

The application provides a clamping device and a testing system for testing membrane bonding force of a covered stent, which comprise a far-end clamping piece and a near-end clamping piece; the outer diameter of the first supporting part is matched with the inner diameter of the guiding section of the near end of the covered stent, and the outer diameter of the first limiting part is larger than the inner diameter of a port of the near end of the covered stent; the outer diameter of the second supporting part is matched with the inner diameter of the anchoring section at the far end of the covered stent, and the outer diameter of the second limiting part is larger than the inner diameter of the port at the far end of the covered stent; the outer contour of the first hollow-out part is smaller than the outer contour of at least one stent gap in a plurality of stent gaps on the guiding section of the proximal end of the covered stent; the outer contour of the second hollowed-out portion is smaller than the outer contour of at least one of the stent gaps on the anchoring section at the distal end of the stent graft. The application can keep the stability of the stent not to deform when testing the membrane adhesion force of the covered stent, can judge and acquire the state that the membrane falls off in time, and can be well suitable for the membrane adhesion force test process of the covered stent.

Description

Clamping device and system for membrane adhesion test of covered stent
Technical Field
The utility model relates to the field of medical instrument testing, in particular to a clamping device for testing membrane bonding force of a covered stent.
Background
Urethral stenting has been a major development in our country in recent years. The current method commonly used in clinic is to place a urethral stent at the urethral stricture and to prop open the urethral stricture or obstruction. The bracket is made of stainless steel, synthetic fiber silica gel or nickel-titanium alloy, can be placed on the narrow part of the urethra through a cystoscope, expands the originally narrow and closed posterior urethra, and can restore the urination function of most patients with urination difficulty after the urethral bracket is placed.
After the urethral stent is subjected to the film covering process, the film covering liquid is bonded with the urethral stent connecting ribs, the film covering liquid forms a film on the surface of the urethral stent, and the film is separated from the urethral stent connecting ribs in the finished product inspection of the covered stent (the covered stent is released in a human body model). And in subsequent animal experiments (the covered stent is released in the animal urethra), the membrane is separated from the stent connecting ribs, so that the urethral stent cannot realize the functions. In the prior art, a better device and scheme for detecting the adhesive force between the membrane of the covered stent and the connecting rib of the stent are not provided, and the stability of the membrane covering process of the covered stent is verified.
SUMMERY OF THE UTILITY MODEL
In order to solve the technical problems, the utility model provides a clamping device and a testing system for testing the membrane adhesion force of a covered stent, which can keep the stability and the non-deformation of the stent when the membrane adhesion force of the covered stent is tested, can judge and acquire the membrane falling state in time, and can be well suitable for the membrane adhesion force testing process of the covered stent.
The technical effects of the utility model are realized as follows:
a clamping device for testing membrane bonding force of a covered stent comprises a far-end clamping piece and a near-end clamping piece;
the near-end clamping piece comprises a first limiting part and a first supporting part, the outer diameter of the first supporting part is matched with the inner diameter of the guiding section of the near end of the covered stent, and the outer diameter of the first limiting part is larger than the inner diameter of a port of the near end of the covered stent; the far-end clamping piece comprises a second limiting part and a second supporting part, the outer diameter of the second supporting part is matched with the inner diameter of the anchoring section at the far end of the covered stent, and the outer diameter of the second limiting part is larger than the inner diameter of the port at the far end of the covered stent; the first support part is provided with a first hollow-out part, and the outer contour of the first hollow-out part is smaller than that of at least one of the stent gaps on the guide section of the proximal end of the covered stent; and a second hollow part is arranged on the second supporting part, and the outer contour of the second hollow part is smaller than the outer contour of at least one of the plurality of stent gaps on the anchoring section at the far end of the covered stent.
Further, the first hollowed-out portion is configured such that, when the first limiting portion is attached to the proximal end of the stent graft, the first hollowed-out portion is located inside one of the stent gaps that is larger than the outer contour of the stent graft;
the second hollowed-out portion is configured such that, when the second limiting portion is attached to the proximal end of the stent graft, the second hollowed-out portion is located inside one of the stent gaps that is larger than the outer contour of the stent graft.
Furthermore, the first hollowed-out parts are multiple and are symmetrically arranged on two sides of the first supporting part.
Further, the second supporting part comprises a first conical surface and a second conical surface, and the first conical surface and the second conical surface are matched with the inner diameter of the positioning part of the anchoring section of the covered stent; and the first conical surface and/or the second conical surface are/is provided with a second hollow part.
The outer contours of the first limiting part and the second limiting part are at least partially non-circular outer contours.
In another aspect, the present application provides a system for testing membrane adhesion of a stent graft, comprising a clamping device for testing as described above.
The device further comprises a testing machine and a force measuring pressure rod, wherein the force measuring pressure rod is fixedly connected with a driving device of the testing machine, and the pressing position of the force measuring pressure rod corresponds to the support of the covered support.
Further, the dynamometry depression bar includes fixed connection's centre gripping connecting portion, pressure transmission portion and test pressure head in proper order, centre gripping connecting portion be used for with the drive arrangement fixed connection of testing machine, the test pressure head is used for extrudeing the membrane on the support clearance of tectorial membrane support.
Furthermore, the testing machine also comprises a force measuring module for detecting and recording the pressure of the force measuring pressure rod driven by the driving device.
As described above, the present invention has the following advantageous effects,
1) the clamping device and the testing system for testing the membrane bonding force of the covered stent can keep the stability and the non-deformation of the stent when testing the membrane bonding force of the covered stent, can judge and acquire the membrane falling state in time, and can be well suitable for the membrane bonding force testing process of the covered stent;
2) the first hollow-out part and the second hollow-out part are just arranged to correspond to the inner part of the bracket gap to be tested, so that the bracket around the bracket gap to be tested can be well supported without deformation, and the film can be smoothly separated after being pressed;
3) the multi-point test fixture is provided with a plurality of hollow parts, and after the covered stent and the test fixture in the embodiment are assembled, a multi-point test can be carried out, and a plurality of tests can also be carried out after the covered stent is turned over;
4) the testing machine also comprises a force measuring module for detecting and recording the pressure of the force measuring pressure rod driven by the driving device, so that the real-time pressure data in the force measuring module can be obtained when the membrane is separated from the bracket connecting rib, and the adhesive force between the membrane and the urethral bracket connecting rib can be measured.
Drawings
In order to more clearly illustrate the technical solution of the present invention, the drawings used in the description of the embodiment or the prior art will be briefly described below. It is obvious that the drawings in the following description are only some embodiments of the utility model, and that for a person skilled in the art it is also possible to derive other drawings from these drawings without inventive effort.
FIG. 1 is a schematic structural view of a stent graft being tested in the present application;
FIGS. 2(a) - (c) are schematic views of the proximal holding device from different perspectives;
FIGS. 3(a) - (c) are schematic views of the distal holding device from different perspectives;
FIG. 4 is a schematic view of a force strut according to an embodiment of the present disclosure;
FIG. 5 is a top view of a clamping device of an embodiment of the present application during assembly to a stent graft;
FIG. 6 is a side view of a clamping device of an embodiment of the present application during assembly to a stent graft.
Wherein the reference numbers in the drawings correspond to the following:
the device comprises a near-end clamping piece 1, a first limiting part 11, a first supporting part 12, a first hollowed-out part 13, a far-end clamping piece 2, a second limiting part 21, a second supporting part 22, a first conical surface 221, a second conical surface 222, a second hollowed-out part 23, a covered stent 3, a guiding section 31, an anchoring section 32, a stent gap 33, a positioning part 321, a force measuring pressure rod 4, a clamping connecting part 41, a pressure transmitting part 42 and a testing pressure head 43.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
Example one
The clamping device for testing the membrane adhesion force of the covered stent in the embodiment belongs to test equipment of medical instruments, and is used for detecting the adhesion force of a covered stent membrane and a stent connecting rib and verifying the stability of a covered stent membrane covering process. The definition of the azimuth appearing in the present application is specifically: the proximal end is the end of the stent close to the operator when the operator places the stent, and the distal end is the end of the stent far from the operator when the operator places the stent, as can also be seen from fig. 1, specifically, the left end of the stent graft in the figure is the proximal end, and the right end is the distal end.
Specifically, as shown in fig. 1 to 6, the clamping device for membrane adhesion test of a stent graft of the present embodiment includes a distal clamping member 2 and a proximal clamping member 1, which are respectively used for fixing the proximal end and the distal end of the stent graft 3, specifically, the stent graft includes a guiding section 31 and an anchoring section 32, which are sequentially arranged from the proximal end to the distal end, the guiding section 31 is used for urethral catheterization, and the anchoring section 32 is used for positioning in cooperation with the bladder neck. Wherein, the outer diameter of the anchoring section 32 is larger than that of the guiding section 31, and the anchoring section 3 comprises a positioning part 321 for positioning with the bladder neck, which is specifically formed by a large middle and two small sides. The stent graft in the present embodiment is specifically a urinary tract stent, and in other embodiments, is not limited to a stent for a urinary tract. Specifically, in order to be elastic, the stent in this embodiment is a collapsible stent having stent gaps 33, and the coating on the stent gaps 33 needs to be tested for adhesion to determine the pressure at which the coating is released from the urethral stent struts.
In this embodiment, in order to meet the above test function requirement, specifically, the proximal clamping member 1 includes a first limiting portion 11 and a first supporting portion 12, an outer diameter of the first supporting portion 12 matches an inner diameter of the guiding section 31 of the proximal end of the stent graft, and an outer diameter of the first limiting portion 11 is greater than an inner diameter of a port of the proximal end of the stent graft;
the far-end clamping piece 2 comprises a second limiting part 21 and a second supporting part 22, the outer diameter of the second supporting part 22 is matched with the inner diameter of the anchoring section 32 at the far end of the covered stent, and the outer diameter of the second limiting part 21 is larger than the inner diameter of a port at the far end of the covered stent.
Thereby, the first supporting part 12 and the second supporting part 22 can be respectively inserted into the near end and the far end of the tectorial membrane bracket 3, and the first limiting part 11 and the second limiting part 12 are matched to realize clamping and positioning of two sides.
Further, in the present embodiment, the first hollow portion 13 is disposed on the first supporting portion 12, and an outer contour of the first hollow portion 13 is smaller than an outer contour of at least one stent gap 33 of the plurality of stent gaps 33 on the guiding section 31 of the proximal end of the stent graft; the second hollow portion 23 is arranged on the second supporting portion 22, and the outer contour of the second hollow portion 23 is smaller than the outer contour of at least one stent gap 33 in the plurality of stent gaps 33 on the anchoring section 32 at the far end of the covered stent, that is, the first hollow portion 13 is arranged on the first supporting portion 12 and the second hollow portion 23 is arranged on the second supporting portion 22, so that the supporting stent can prevent the stent from deforming, and meanwhile, the membrane can be smoothly separated when the membrane is subjected to pressure larger than the separation pressure so as to be convenient for observation. After the first hollowed-out part 13 and the second hollowed-out part 23 are configured on the bracket at the far-end clamping piece 2 and the near-end clamping piece 1, the first hollowed-out part 13 and the second hollowed-out part 23 are just arranged to correspond to the inner part of the bracket gap to be tested, so that the bracket around the bracket gap to be tested can be well supported without deformation, and the film can be smoothly separated after being pressed.
Specifically, the positions of the first hollowed-out portion 13 and the second hollowed-out portion 23 are set such that, when the first limiting portion 11 is fitted to the proximal end of the stent graft, the first hollowed-out portion 13 is located inside one of the stent gaps 33, which is larger than the outer profile thereof; when the second limiting portion 21 is attached to the proximal end of the stent graft, the second hollow portion 23 is located inside one of the stent gaps 33 that is larger than the outer contour thereof.
Further preferably, as shown in the perspective view of fig. 2(c), the number of the first hollow-out portions 13 is multiple, and the multiple first hollow-out portions 13 are symmetrically disposed on two sides of the first supporting portion 12, in this embodiment, as shown in the drawing, the number of the first hollow-out portions 13 is four, and two of the first hollow-out portions are symmetrically disposed on two sides of the first supporting portion 12, so that after the stent graft and the clamping device for testing in this embodiment are assembled, a multi-point test can be performed, and a plurality of tests can also be performed after the stent graft is turned over.
Further, in the present embodiment, the second support portion 22 includes a first tapered surface 221 and a second tapered surface 222, and the first tapered surface 221 and the second tapered surface 222 match with the inner diameter of the positioning portion 321 of the anchoring section 32 of the stent graft; the first tapered surface 221 and/or the second tapered surface 222 are/is provided with a second hollowed-out portion 23. Since the stent graft in the present application can be expanded and deformed, the second support portion 22 can be pressed into the anchoring section 32 at the distal end of the stent graft 3 and better fit with the positioning portion 321 of the anchoring section 32 through the two tapered surfaces.
Further, the outer contour of the first limiting portion 11 and the outer contour of the second limiting portion 21 are at least partially non-circular outer contours, preferably regular polygons, the outer diameters of the first limiting portion 11 and the second limiting portion 21 can be the same, it can be guaranteed that after the covered stent is supported and positioned by the near-end clamping piece and the far-end clamping piece, the whole testing device can be placed or clamped on the testing platform through the first limiting portion and the second limiting portion, and due to the non-circular outer contours, the tool can be prevented from rotating or moving during testing, and testing results are affected.
Example two:
in one embodiment, a system for testing membrane adhesion of a stent graft includes the clamping device of the first embodiment. Further specifically, in this embodiment, the device further includes a testing machine and a force measurement pressure lever 4, the force measurement pressure lever 4 is fixedly connected to a driving device of the testing machine, a pressing position of the force measurement pressure lever 4 corresponds to a stent of the stent graft, that is, an adjustable position of the force measurement pressure lever 4 aligns to a stent graft in a gap of the stent graft to be tested, and then the driving device drives the pressing device to press down, so as to test the stent graft. The testing machine is preferably a WDW-05 type microcomputer control electronic universal testing machine, the device is provided with a computer system, the computer system controls a servo motor to rotate through a controller speed regulating system, and the moving beam is driven to ascend and descend through a precision lead screw pair after being decelerated by a deceleration system, so that various mechanical property tests such as stretching, compression, bending, shearing and the like are completed.
Specifically, the force measuring pressure rod 4 comprises a clamping connecting part 41, a pressure transmitting part 42 and a testing pressure head 43 which are fixedly connected in sequence, the clamping connecting part 41 is fixedly connected with a driving device of the testing machine, the testing pressure head 43 is used for extruding a membrane on a stent gap 33 of the covered stent, and the testing machine further comprises a force measuring module used for detecting and recording the pressure of the driving force measuring pressure rod 4 driven by the driving device, so that real-time pressure data in the force measuring module can be obtained when the membrane is separated from a stent connecting rib, and the bonding force of the membrane and a urethral stent connecting rib can be measured.
Specifically, based on the system, the test process of the present application is as follows:
1. the near-end clamping piece is inserted from the near end of the covered stent, the first supporting part penetrates through the near-end inner hole of the covered stent, the positions of the covered stent and the first supporting part are adjusted, and the film between the connecting ribs of the covered stent is ensured to be aligned with the first hollowed-out part.
2. The far-end clamping piece is inserted from the far end of the covered stent, the second supporting part penetrates through the inner hole in the far end of the covered stent, the positions of the covered stent and the second supporting part are adjusted, and the film between the connecting ribs of the covered stent is ensured to be aligned with the second hollowed-out part.
3. The tectorial membrane support after clamping device is used in the installation is placed on the testing machine platform.
4. And adjusting the distance between the upper platform of the testing machine and the covered stent, ensuring the installation space of the upper tool for the bonding force test, and fixing the force measuring pressure rod and the driving device of the testing machine relatively by using a G-shaped fixing frame.
5. The position of the covered stent provided with the clamping device is adjusted, the hollow-out parts of the connecting ribs of the covered stent (the covered positions of the gaps between the stents corresponding to the first hollow-out parts and the second hollow-out parts) are vertically corresponding to the stress position of the force measuring pressure rod, and the stress point of the force measuring pressure rod can be aligned to the film of the covered stent to apply force and press down when the driving device on the testing machine moves up and down.
6. And observing the stress change process of the membrane of the covered stent in the continuous pressing process of the driving device on the testing machine, and if the membrane is separated or damaged, immediately stopping the testing machine. Observing test software of the testing machine, acquiring data from the force measuring module, obtaining a test force-time curve, and determining the maximum force in the rectifying and reforming experiment process, wherein the force is the force when the membrane of the covered stent is separated from the connecting rib.
According to the embodiment, the application has the following beneficial effects:
1) the clamping device and the testing system for testing the membrane adhesion force of the covered stent can keep the stability and the non-deformation of the stent when testing the membrane adhesion force of the covered stent, can judge and acquire the membrane falling state in time, and can be well suitable for the membrane adhesion force testing process of the covered stent;
2) the first hollow-out part and the second hollow-out part are just arranged to correspond to the inner part of the bracket gap to be tested, so that the bracket around the bracket gap to be tested can be well supported without deformation, and the film can be smoothly separated after being pressed;
3) the multi-point test fixture is provided with a plurality of hollow parts, and after the covered stent and the test fixture in the embodiment are assembled, a multi-point test can be carried out, and a plurality of tests can also be carried out after the covered stent is turned over;
4) the testing machine also comprises a force measuring module for detecting and recording the pressure of the force measuring pressure rod driven by the driving device, so that the real-time pressure data in the force measuring module can be obtained when the membrane is separated from the bracket connecting rib, and the adhesive force between the membrane and the urethral bracket connecting rib can be measured.
Although the present invention has been described by way of preferred embodiments, the present invention is not limited to the embodiments described herein, and various changes and modifications may be made without departing from the scope of the present invention.
In this document, the terms front, back, upper and lower are used to define the components in the drawings and the positions of the components relative to each other, and are used for clarity and convenience of the technical solution. It is to be understood that the use of the directional terms should not be taken to limit the scope of the claims.
The embodiments and features of the embodiments described herein above can be combined with each other without conflict.
While the utility model has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the utility model is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims (9)

1. A clamping device for testing the membrane bonding force of a covered stent is characterized in that,
comprises a near-end clamping piece (1) and a far-end clamping piece (2);
the near-end clamping piece (1) comprises a first limiting part (11) and a first supporting part (12), the outer diameter of the first supporting part (12) is matched with the inner diameter of a guide section (31) of the near end of the covered stent, and the outer diameter of the first limiting part (11) is larger than the inner diameter of a port of the near end of the covered stent;
the far-end clamping piece (2) comprises a second limiting part (21) and a second supporting part (22), the outer diameter of the second supporting part (22) is matched with the inner diameter of an anchoring section (32) at the far end of the covered stent, and the outer diameter of the second limiting part (21) is larger than the inner diameter of a port at the far end of the covered stent;
a first hollow-out part (13) is arranged on the first supporting part (12), and the outer contour of the first hollow-out part (13) is smaller than the outer contour of at least one stent gap (33) in a plurality of stent gaps (33) on the guiding section (31) of the proximal end of the covered stent;
the second support part (22) is provided with a second hollowed-out part (23), and the outer contour of the second hollowed-out part (23) is smaller than the outer contour of at least one stent gap (33) in the plurality of stent gaps (33) on the anchoring section (32) at the far end of the covered stent.
2. The clamping device for membrane adhesion test of a stent graft of claim 1, wherein,
the first hollowed-out part (13) is arranged such that, when the first limiting part (11) is attached to the proximal end of the stent graft, the first hollowed-out part (13) is located inside one of the stent gaps (33) which is larger than the outer contour thereof;
the second hollowed-out portion (23) is configured such that, when the second limiting portion (21) is attached to the proximal end of the stent graft, the second hollowed-out portion (23) is located inside one of the stent gaps (33) that is larger than the outer profile thereof.
3. The clamping device for testing the membrane bonding force of the covered stent according to claim 1, wherein the number of the first hollowed-out portions (13) is multiple, and the multiple first hollowed-out portions (13) are symmetrically arranged on two sides of the first supporting portion (12).
4. The clamping device for membrane adhesion test of a stent graft of claim 1, wherein,
the second supporting part (22) comprises a first conical surface (221) and a second conical surface (222), and the first conical surface (221) and the second conical surface (222) are matched with the inner diameter of a positioning part (321) of the anchoring section (32) of the covered stent; the first conical surface (221) and/or the second conical surface (222) are/is provided with a second hollow-out part (23).
5. The clamping device for membrane adhesion test of a stent graft of claim 1, wherein,
the outer contours of the first limiting part (11) and the second limiting part (21) are at least partially non-circular outer contours.
6. A membrane adhesion testing system for stent grafts, comprising the test fixture of any of claims 1-5.
7. The membrane adhesion force test system of a covered stent according to claim 6, further comprising a testing machine and a force measuring pressure rod (4), wherein the force measuring pressure rod (4) is fixedly connected with a driving device of the testing machine, and the pressing position of the force measuring pressure rod (4) corresponds to the stent of the covered stent.
8. The membrane adhesion test system of a stent graft according to claim 7, wherein the force measuring pressure rod (4) comprises a clamping connection part (41), a pressure transmission part (42) and a test pressure head (43) which are fixedly connected in sequence, the clamping connection part (41) is fixedly connected with a driving device of the testing machine, and the test pressure head (43) is used for extruding the membrane on the stent graft gap (33).
9. The membrane adhesion test system of a stent graft of claim 7, wherein the testing machine further comprises a force measuring module for detecting and recording the amount of pressure of the force measuring pressure rod (4) driven by the driving device.
CN202120892637.1U 2021-04-25 2021-04-25 Clamping device and system for membrane adhesion test of covered stent Active CN216771463U (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202120892637.1U CN216771463U (en) 2021-04-25 2021-04-25 Clamping device and system for membrane adhesion test of covered stent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202120892637.1U CN216771463U (en) 2021-04-25 2021-04-25 Clamping device and system for membrane adhesion test of covered stent

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Publication Number Publication Date
CN216771463U true CN216771463U (en) 2022-06-17

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Inventor after: Huang Lei

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Inventor after: Liu Jun

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Inventor before: Chen Chaohui

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