Support removal force test tool

Abstract

The utility model provides a support removing force test tool comprising a loading member and a clamping assembly arranged on the loading member. The clamping assembly comprises a first clamping piece and a second clamping piece; the first clamping piece is provided with a first surface, and a first groove hole is formed in the first surface. The second clamping piece is provided with a second surface, and a second groove hole is formed in the second surface. The first clamping piece is rotatably connected with the second clamping piece so as to allow the first surface and the second surface to be separated or at least partially clung to each other; the first slotted hole and the second slotted hole are spliced to form a mounting hole when the first surface and the second surface at least partially abut against each other. The clamping assembly is used for clamping the support system when the removal force test is carried out on the support, so that man-made influences can be reduced in the test process, and the test process is more stable and more reliable.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a stent removal force testing fixture. Background Technology

[0002] A vascular stent is a transluminal, balloon-expandable or self-expanding implant that provides mechanical support to a blood vessel after implantation and deployment, in order to maintain or restore the vessel's integrity. For balloon-expandable stents, they are gripped in a balloon and then delivered and released into the blood vessel via a delivery device.

[0003] When delivering balloon-expandable stents using a delivery device, if the friction between the stent and the balloon is too low when the delivery device passes through the lesion or tortuous blood vessel, the stent may dislodge before deployment, leading to stent embolism. Therefore, it is necessary to test the removal force between the stent and the balloon. Utility Model Content

[0004] The purpose of this invention is to provide a fixture for testing the force of stent removal, which aims to improve the reliability of stent removal force testing.

[0005] To achieve the above objectives, this utility model provides a bracket removal force testing fixture, including a loading component and a locking assembly, wherein the locking assembly is used to be mounted on the loading component; the locking assembly includes:

[0006] The first fastener has a first surface, on which a first slot is formed;

[0007] The second engaging component has a second surface on which a second slot is formed;

[0008] The first engaging member and the second engaging member are rotatably connected to allow the first surface to separate from or at least partially abut against the second surface; the first slot and the second slot are assembled to form a mounting hole when the first surface and the second surface are at least partially abut against each other.

[0009] Optionally, the engaging assembly further includes a fastener for connecting with the first engaging member and the second engaging member, such that the first surface and the second surface remain in at least partially abutting.

[0010] Optionally, the first engaging member has a third surface, which is at least partially opposite to the first surface; the third surface is provided with a first engaging groove, which is located at least on the portion of the third surface opposite to the first surface;

[0011] The second engaging member has a fourth surface, which is at least partially opposite to the second surface; a second engaging groove is provided on the fourth surface, which is at least located on the portion of the fourth surface opposite to the second surface;

[0012] The fastener includes a clamp that is partially disposed within the first engagement groove and applies a radially inward force along the first slot to the first engaging member; the clamp is also partially disposed within the second engagement groove and applies a radially inward force along the second slot to the second engaging member.

[0013] Optionally, the clamp includes two interconnected clamp rods, each clamp rod having a free end away from the other clamp rod; one clamp rod is used to be at least partially disposed within the first engagement groove, and the other clamp rod is used to be at least partially disposed within the second engagement groove.

[0014] Optionally, the first engaging member includes a first main body and a first edge portion, wherein there are two first edge portions, which are respectively connected to opposite sides of the first main body; the thickness of the first edge portion is less than the thickness of the first main body, and the thickness is the axial dimension of the first engaging member in the first slot;

[0015] The second engaging component includes a second main body and a second edge portion. There are two second edge portions, which are respectively connected to opposite sides of the second main body. Each second edge portion is provided with a third engaging groove, which penetrates the second surface.

[0016] Two second edge portions are provided in a one-to-one correspondence with two first edge portions; one first edge portion is at least partially accommodated in the third engagement groove of the corresponding second edge portion and is rotatably connected to the corresponding second edge portion, and the other first edge portion is at least partially accommodated in the third engagement groove of the corresponding second edge portion when the first surface and the second surface are at least partially abutted.

[0017] Optionally, the first edge portion is at least partially located on the same side of a first preset plane as the first main body portion, the first preset plane passing through the axis of the mounting hole and the rotation axis of the first engaging member and the second engaging member; the width of the portion of the first edge portion located on the same side of the first main body portion as the first preset plane decreases in a direction away from the first main body portion, and the width is the dimension of the first engaging member in a first preset direction, the first preset direction being perpendicular to the arrangement direction of the first edge portion and the first main body portion;

[0018] The portion of the third surface located in the first main body is arranged opposite to the first surface;

[0019] The two ends of the first engagement groove extend to the two first edge portions respectively; the lever for being at least partially disposed within the first engagement groove is V-shaped.

[0020] Optionally, the second edge portion is at least partially located on the same side of the second main body portion on the second preset plane, the second preset plane passing through the axis of the second slot and the rotation axis of the second engaging member and the first engaging member; the width of the portion of the second edge portion located on the same side of the second main body portion on the second preset plane decreases in the direction away from the second main body portion, the width being the dimension of the second engaging member in a second preset direction, the second preset direction being perpendicular to the arrangement direction of the second edge portion and the second main body portion;

[0021] The portion of the fourth surface located on the second main body is arranged opposite to the second surface;

[0022] The two ends of the second engagement groove extend to the two second edge portions respectively, and the locking rod, which is at least partially disposed in the first engagement groove, is V-shaped; and / or, the second engagement groove communicates with at least one of the third engagement grooves.

[0023] The lever for at least partially set in the first engagement groove is V-shaped. A first pre-positioning element is also provided on the first surface, and a second pre-positioning element is also provided on the second surface.

[0024] One of the first prepositioning member and the second prepositioning member is a protrusion, and the other is a recess.

[0025] Optionally, the mounting hole includes a first hole segment, which is a tapered hole.

[0026] The lever for being at least partially disposed within the first engagement groove is V-shaped. The loading component includes a third main body portion, on which a fourth engagement groove and a fifth engagement groove are provided.

[0027] The fourth engagement groove extends axially along the third main body and has a first opening through at least one end face of the third main body; the fourth engagement groove also has a second opening through one side face of the third main body.

[0028] The fifth engagement groove includes two slots, which are aligned axially on the third main body and respectively disposed on opposite sides of the fourth engagement groove; the slots communicate with the fourth engagement groove; the slots also penetrate one side of the third main body and have a third opening, which is located on the same side of the third main body as the second opening.

[0029] Compared with the prior art, the bracket removal force testing fixture of this utility model has the following advantages:

[0030] The aforementioned bracket removal force testing fixture includes a loading component and a locking assembly. The locking assembly is mounted on the loading component. The locking assembly includes a first locking member and a second locking member. The first locking member has a first surface with a first slot formed thereon. The second locking member has a second surface with a second slot formed thereon. The first locking member and the second locking member are rotatably connected to allow the first surface to separate from or at least partially abut against the second surface. The first slot and the second slot are assembled to form a mounting hole when the first surface and the second surface are at least partially abut against each other. The locking assembly is used to clamp the bracket system during bracket removal force testing, thereby reducing human interference during the testing process and making the testing process more stable and reliable. Attached Figure Description

[0031] The accompanying drawings are provided to better understand this utility model and do not constitute an undue limitation thereof. Wherein:

[0032] Figure 1 This is a schematic diagram of the loading component of the bracket removal force testing fixture provided according to an embodiment of the present invention;

[0033] Figure 2 This is a partial structural schematic diagram of the loading component of the bracket removal force testing fixture provided according to an embodiment of the present invention;

[0034] Figure 3 This is another partial structural schematic diagram of the loading component of the bracket removal force testing fixture provided according to one embodiment of the present invention;

[0035] Figure 4 This is a schematic diagram of the engaging assembly of the bracket removal force testing fixture provided in one embodiment of the present invention;

[0036] Figure 5 This is a partial structural schematic diagram of the engaging component of the bracket removal force testing fixture provided according to an embodiment of the present invention;

[0037] Figure 6This is another partial structural schematic diagram of the engaging assembly of the bracket removal force testing fixture provided in one embodiment of the present invention;

[0038] Figure 7 This is another partial structural schematic diagram of the engaging assembly of the bracket removal force testing fixture provided in one embodiment of the present invention;

[0039] Figure 8 This is another partial structural schematic diagram of the engaging assembly of the bracket removal force testing fixture provided in one embodiment of the present invention;

[0040] Figure 9 This is a schematic diagram of the engagement component and the support system of the support removal force testing fixture provided according to an embodiment of the present invention. The first engagement component is not shown in the figure.

[0041] Figure 10 This is a schematic diagram of the engagement component and the support system of the support removal force testing fixture provided in one embodiment of the present invention.

[0042] [The annotations in the attached figures are explained below]:

[0043] 100 - Loading component, 110 - Third main body portion, 111 - Fourth engagement groove, 112 - Slot, 120 - Engaging portion, 200 - Engaging assembly, 201 - Mounting hole, 210 - First engaging component, 210a - First main body portion, 210b - First edge portion, 211 - First surface, 211a - First area, 212 - First slot, 213 - First pre-positioning component, 214 - Third surface, 215 - First engagement groove, 220 - Second engaging component, 220a - Second main body, 220b - second edge, 221 - second surface, 221a - second region, 222 - second slot, 222a - second segment, 222b - fourth segment, 223 - second prepositioning member, 224 - fourth surface, 225 - second engagement groove, 226 - third engagement groove, 230 - fastener, 231 - first locking rod, 232 - second locking rod, 233 - connecting rod, 240 - rotating shaft, 20 - support system, 21 - support, 22 - balloon. Detailed Implementation

[0044] The following specific examples illustrate the implementation of this utility model. Those skilled in the art can easily understand other advantages and effects of this utility model from the content disclosed in this specification. This utility model can also be implemented or applied through other different specific embodiments, and various details in this specification can be modified or changed based on different viewpoints and applications without departing from the spirit of this utility model. It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of this utility model. Therefore, the drawings only show components related to this utility model and are not drawn according to the actual number, shape, and size of the components in implementation. In actual implementation, the type, quantity, and proportion of each component can be arbitrarily changed, and the component layout may also be more complex.

[0045] Furthermore, while each embodiment described below possesses one or more technical features, this does not imply that users of this utility model must simultaneously implement all technical features in any embodiment, or can only separately implement some or all technical features in different embodiments. In other words, provided it is feasible, those skilled in the art can selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, based on the disclosure of this utility model and depending on design specifications or implementation requirements, thereby increasing the flexibility in implementing this utility model.

[0046] As used herein, the singular forms “a,” “an,” and “the” include plural objects, and the plural form “multiple” includes two or more objects, unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or,” unless otherwise expressly indicated, and the terms “installed,” “connected,” and “linked” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection. Connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can be internal communication between two elements or an interaction between two elements. Relational terms such as “first,” “second,” etc., are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly specify the number of indicated technical features. It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. For those skilled in the art, the specific meaning of the above terms in this utility model can be understood according to the specific circumstances.

[0047] The purpose of this invention is to provide a stent removal force testing fixture, which is used to test the removal force of a stent held on a balloon, and has the advantage of reliable test results.

[0048] To make the objectives, advantages, and features of this utility model clearer, the following detailed description is provided in conjunction with the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to conveniently and clearly illustrate the objectives of the embodiments of this utility model. The same or similar reference numerals in the drawings represent the same or similar parts.

[0049] like Figures 1 to 10As shown, the bracket removal force testing fixture provided in this embodiment of the present invention includes a loading member 100 and a locking assembly 200. The locking assembly 200 includes a first locking member 210 and a second locking member 220. The first locking member 210 has a first surface 211 on which a first slot 212 is formed. The second locking member 220 has a second surface 221 on which a second slot 222 is formed. The second locking member 220 is rotatably connected to the first locking member 210. Through relative rotation of the second locking member 220 and the first locking member 210, the first surface 211 and the second surface 221 can be separated or at least partially abutted. When the first surface 211 and the second surface 221 are at least partially abutted, the first slot 212 and the second slot 222 are combined to form a mounting hole 201.

[0050] When performing a removal force test on the bracket system 20 using the bracket removal force testing fixture, the first and second engaging members are rotated until the first slot 212 and the second slot 222 are joined to form the mounting hole 201, and the bracket system 20 is partially inserted through the mounting hole 201, so that the engaging assembly 200 clamps the bracket system 20 through the cooperation of the first engaging member 210 and the second engaging member 220. This allows the engaging assembly 200 to fix the bracket system 20 onto the loading member 100. Then, the loading member 100 is connected to one end of the mechanical testing machine, and the other end of the bracket system 20 is connected to the other end of the mechanical testing machine. Finally, a tensile force is applied to the bracket system 20 by the mechanical testing machine to obtain the bracket removal force of the bracket system 20. By using the engaging assembly 200 to clamp the bracket system 20, the accuracy and consistency of the measurement results can be ensured, as it is not affected by the operator.

[0051] It is understood that the stent system 20 includes a stent 21, a balloon catheter, and a delivery device. Both the balloon 22 of the balloon catheter and the stent are held within the delivery device, and the stent 21 is fitted onto the balloon 22. The "stent removal force" refers to the tensile force applied by the mechanical testing machine when the balloon 22, in its held state, separates from the stent 21, which is also in its held state.

[0052] The following is a more detailed description of the stent removal force testing fixture. The following description is based on only a preferred embodiment of the stent removal force testing fixture and is not a necessary structure of the fixture, nor should it unduly limit the scope of this invention.

[0053] Optionally, at least a portion of the first surface 211 of the first engaging member 210 is planar, and the first slot 212 is provided on the planar area of ​​the first surface 211. Similarly, at least a portion of the second surface 221 of the second engaging member 220 is planar, and the second slot 222 is provided on the planar area of ​​the second surface 221. For ease of description, the planar area of ​​the first surface 211 is referred to as the first region 211a, and the planar area of ​​the second surface 221 is referred to as the second region 221a. Thus, the first slot 212 is provided on the first region 211a, and the second slot 222 is provided on the second region 221a. Moreover, through relative rotation of the first engaging member 210 and the second engaging member 220, the first region 211a and the second region 221a are separated from each other, or the first region 211a and the second region 221a are brought into contact with each other, so that the first slot 212 and the first slot 222 are combined to form the mounting hole 201.

[0054] Optionally, the first slot 212 includes at least a first segment, the wall of which is a portion of a conical surface. The second slot 222 includes at least a second segment 222a, the wall of which is a portion of a conical surface. When the first region 211a and the second region 221a are in contact with each other, the first segment and the second segment 222a are combined to form a conical first hole segment, which is at least a portion of the mounting hole 201.

[0055] Optionally, the first slot 212 may further include a third segment, the wall of which is part of a circumferential surface, and the third segment is connected to the smaller diameter end of the conical surface where the hole wall of the first segment is located. The second slot 222 may include a fourth segment 222b, the wall of which is part of a circumferential surface, and the fourth segment 222b is connected to the smaller diameter end of the conical surface where the hole wall of the second segment 222a is located. When the first region 211a and the second region 221a are in contact with each other, the third segment and the fourth segment 222b are combined to form a cylindrical second hole segment, the second hole segment being located at the smaller diameter end of the first hole segment and constituting part of the mounting hole 201.

[0056] That is, the mounting hole 201 may include a conical first hole segment and a cylindrical second hole segment. It should be understood that the diameter of the second hole segment is equal to the minimum diameter of the first hole segment. The minimum diameter of the second hole segment is determined based on the stent system 20 to be tested; specifically, the minimum diameter of the second hole segment is approximately equal to the outer diameter of the balloon in the gripped state and smaller than the outer diameter of the stent 21 in the gripped state. Thus, during testing, the balloon in the gripped state can pass through the mounting hole 201 along the direction from the first hole segment to the second hole segment under tension, while the stent 21 in the gripped state cannot pass through the mounting hole 201 along the same direction. It can be understood that when the balloon in the gripped state passes through the mounting hole 201 along the direction from the first hole segment to the second hole segment, the balloon in the gripped state separates from the stent 21 in the gripped state.

[0057] Optionally, a first pre-positioning member 213 is further provided on the first surface 211, and a second pre-positioning member 223 is further provided on the second surface 221. The second pre-positioning member 223 and the first pre-positioning member 213 are used for pre-positioning when the first engaging member 210 and the second engaging member 220 are spliced ​​together, so as to reduce the production precision requirements of the engaging assembly 200 and thus reduce the production cost of the engaging assembly 200. One of the first pre-positioning member 213 and the second pre-positioning member 223 is a protrusion and the other is a recess.

[0058] For preferred options, please refer to Figure 7 The engaging assembly 200 further includes a fastener 230, which is used to connect with the first engaging member 210 and the second engaging member 220 during testing, and to apply relative forces to the first engaging member 210 and the second engaging member 220 so that the first engaging member 210 and the second engaging member 220 remain in contact with the first region 211a and the second region 221a. That is, by setting the fastener 230, it can be ensured that the first engaging member 210 and the second engaging member 220 will not rotate to the point where the first slot 212 and the second slot 222 separate and cannot be assembled into the mounting hole 201 during testing, thus ensuring that the engaging assembly 200 can effectively clamp the bracket system 20, allowing the test to proceed smoothly.

[0059] In one example, the first engaging member 210 has a third surface 214, which is at least partially disposed opposite to the first surface 211. A first engaging groove 215 is provided on the third surface 214. The second engaging member 220 has a fourth surface 224, which is at least partially disposed opposite to the second surface 221. A second engaging groove 225 is provided on the fourth surface 224. The fastener 230 includes a clamp that, when the first engaging member 210 and the second engaging member 220 are rotated to abut the first region 211a and the second region 221a, partially engages in the first engaging groove 215 and applies a radially inward force along the first slot 212 to the first engaging member 210, and also partially engages in the second engaging groove 225 and applies a radially inward force along the second slot 212 to the second engaging member 220. Under the force applied by the clamp, the first engaging member 210 and the second engaging member 220 cannot easily rotate in the direction that separates the first region 211a and the second region 221a.

[0060] Optionally, the clamp includes two levers connected by a connecting rod 233, which may be referred to as the first lever 231 and the second lever 232, respectively. The end of the first lever 231 away from the second lever 232 is a free end, and the end of the second lever 232 away from the first lever 231 is also a free end. The first lever 231 is used to at least partially engage with the first engagement groove 215 and apply force to the first engaging member 210, and the second lever 232 is used to at least partially engage with the second engagement groove 225 and apply force to the second engaging member 220.

[0061] It should be noted that the clamp is configured to be elastic. When the first clamp 231 is subjected to a first external force along the direction of the second clamp 232 pointing towards the first clamp 231, the first clamp 231 moves away from the second clamp 232 and stores elastic potential energy; when the first external force is removed, the first clamp 231 releases the elastic potential energy, moves towards the second clamp 232, and returns to its initial position. Similarly, when the second clamp 232 is subjected to a second external force along the direction of the first clamp 231 pointing towards the second clamp 232, the second clamp 232 moves away from the first clamp 231 and stores elastic potential energy; when the second external force is removed, the second clamp 232 releases the elastic potential energy, moves towards the first clamp 231, and returns to its initial position. When the first locking lever 231 is at least partially engaged in the first engaging groove 215, the first engaging member 210 applies an external force to the first locking lever 231 along the direction of the second locking lever 232 pointing towards the first locking lever 231; when the second locking lever 232 is at least partially engaged in the second engaging groove 225, the second engaging member 220 applies an external force to the second locking lever 232 along the direction of the first locking lever 231 pointing towards the second locking lever 232. Thus, the fastener 230 allows the first engaging member 210 and the second engaging member 220 to remain in the state where the first slot 212 and the second slot 222 are combined to form the mounting hole 201, ensuring that the engaging assembly 200 effectively clamps the bracket system 20 during testing.

[0062] Optionally, the first engaging member 210 includes a first main body portion 210a and a first edge portion 210b. There are two first edge portions 210b, each connected to opposite sides of the first main body portion 210a. Similarly, the second engaging member 220 includes a second main body portion 220a and two second edge portions 220b. The two second edge portions 220b are connected to opposite sides of the second main body portion 220a. Each of the two second edge portions 220b corresponds one-to-one with one of the two first edge portions 210b, and each second edge portion 220b is rotatably connected to each first edge portion 210b via a rotating shaft 240.

[0063] The third surface 214 extends from one first edge portion 210b to the first body portion 210a, and further to another first edge portion 210b, with the portion of the third surface 214 on the first body portion 210a arranged opposite to the first surface 211. Optionally, the first latch 231 is V-shaped, and preferably the corners of the V-shape are rounded. Correspondingly, the first edge portion 210b is at least partially located on the same side of a first preset plane as the first body portion 210a. The first preset plane is a plane passing through the axis of the first slot 212 and the rotation axes of the first engaging member 210 and the second engaging member 220. The first preset plane is, for example, the plane where the first region 211a is located. The width of the portion of the first edge portion 210b that is on the same side of the first main body portion 210a on the first preset plane decreases in the direction away from the first main body portion 210a. This width refers to the dimension of the first engaging member 210 in a first preset direction (as shown by the double-headed arrow X in the figure), which is perpendicular to the arrangement direction of the first edge portion 210b and the first main body portion 210a. The two ends of the first engaging groove 215 extend to the two first edge portions 210b respectively, so that the shape of the first engaging groove 215 matches the shape of the first latch 231. The fourth surface 224 extends from one second edge portion 220b to the second main body portion 220a, and further to the other second edge portion 220b, with the portion of the fourth surface 224 on the second main body portion 220a arranged opposite to the second surface 221. Optionally, the second latch 232 is V-shaped, and preferably, the corners of the V-shape are rounded. Correspondingly, the second edge portion 210b is at least partially located on the same side of the second main body portion 220a on a second preset plane. The second preset plane is a plane passing through the axis of the second slot 212 and the rotation axis of the first engaging member 210 and the second engaging member 220. The second preset plane is, for example, the plane where the second region 221a is located. The width of the portion of the second edge portion 220b located on the same side of the second main body portion 220a on the second preset plane decreases in a direction away from the second main body portion 220a. Here, the width refers to the dimension of the second engaging member 220 in a second preset direction (as shown by the double-headed arrow Y in the figure), which is perpendicular to the arrangement direction of the second edge portion 220b and the second main body portion 220a. The two ends of the second engaging groove 225 extend to the second edge portion 220b, so that the shape of the second engaging groove 225 is adapted to the shape of the second latch 232.The advantage of this design is that it improves the clamping effect of the fastener 230 on the first engaging member 210 and the second engaging member 220, making it less likely for the first locking rod 231 to pop out from the first engaging groove 215, and making it less likely for the second locking rod 232 to pop out from the second engaging groove 225.

[0064] It should be understood that when the first region 211a and the second region 221a are in contact, the first preset direction is the same as the second preset direction, and when the first preset plane is the plane where the first region 211a is located and the second preset plane is the plane where the second region 221a is located, the first preset plane and the second preset plane coincide.

[0065] Further, the thickness of the first edge portion 210b is less than the thickness of the first main body portion 210a. The thickness of any element on the first engaging member 210 refers to the axial dimension of that element in the first slot 212. A third engaging groove 226 is formed on the second edge portion 220b, the third engaging groove 226 penetrating the second surface 222. One first edge portion 210b is partially accommodated in the third engaging groove 226 on the corresponding second edge portion 220b and is rotatably connected to the corresponding second edge portion 220b; another first edge portion 210b can be at least partially accommodated in the third engaging groove 226 of the corresponding second edge portion 220 when the first region 211a and the second region 221a are in contact. In addition, the third engaging groove 226 can communicate with the second engaging groove 225.

[0066] This embodiment of the invention does not have special requirements for the materials of the first locking component 210 and the second locking component 220, as long as the materials are easy to process and assemble, and have a long service life. Optional materials include, but are not limited to, stainless steel, aluminum alloy, etc.

[0067] The loading member 100 includes a third main body 110, on which a fourth engaging groove 111 and a fifth engaging groove are provided. The fourth engaging groove 111 extends axially along the third main body 110 and has a first opening, penetrating at least one end face of the third main body 110. The fourth engaging groove 111 also penetrates one side of the third main body 110 and has a second opening. The fifth engaging groove includes two slots 112, which are axially aligned with the third main body 110 and respectively disposed on opposite sides of the fourth engaging groove 111. The slots 112 communicate with the fourth engaging groove 111, and each slot 112 also penetrates one side of the third main body 110 and has a third opening, which is located on the same side of the third main body 110 as the second opening. During operation, the engaging component 200 engages with the fifth engagement groove through the third opening, thereby connecting with the loading component 100. The bracket system 20, which is clamped by the engaging component 200, is located within the fifth engagement groove 111.

[0068] Optionally, the loading member 100 further includes a connecting portion 120, which is connected to the end of the third main body portion 110 away from the first opening. The connecting portion 120 is used for connection with the mechanical testing machine.

[0069] This embodiment of the invention does not impose any special limitations on the structure of the joint 120, as long as it can enable the connection between the loading member 100 and the mechanical testing machine.

[0070] Preferably, the third main body 110 is detachably connected to the joint 120 so that the joint 120 connected to the third main body 110 can be replaced according to the type of the mechanical testing machine.

[0071] The following describes a detailed process for testing the removal force of a bracket using the bracket removal force testing fixture provided in this embodiment of the invention.

[0072] First, the removal force at the proximal end of the stent was tested. The procedure is as follows:

[0073] The portion of the bracket system 20 near the proximal end of the bracket 21 is placed at the first segment of the first slot 212 (or at the third segment of the second slot 222). Then, the first engaging member 210 and the second engaging member 220 are rotated relative to each other so that the first slot 212 and the second slot 222 are assembled into the mounting hole.

[0074] The loading component 100 is connected to the mechanical testing machine. During connection, the joint portion 120 is located below the third main body portion 110, such that the end face where the first opening is located is the upper end face of the third main body portion 110.

[0075] The engaging assembly 200, which clamps the support system 20, is loaded into the fifth engagement groove. During installation, the second hole segment is positioned above the first hole segment, such that the distal end of the support 21 is positioned below the proximal end. The upper end of the support system 20 is then connected to the mechanical testing machine.

[0076] The mechanical testing machine is controlled to apply a tensile force until the balloon separates from the stent 21. The test data is recorded to obtain the removal force at the proximal end of the stent.

[0077] Next, the removal force at the distal end of the stent 21 was tested, as follows:

[0078] The portion of the bracket system 20 near the distal end of the bracket 21 is placed at the first segment of the first slot 212 (or at the third segment of the second slot 222). Then, the first engaging member 210 and the second engaging member 220 are rotated relative to each other so that the first slot 212 and the second slot 222 are assembled into the mounting hole 201.

[0079] The loading component 100 is connected to the mechanical testing machine. During connection, the joint portion 120 is located below the third main body portion 110, such that the end face where the first opening is located is the upper end face of the third main body portion 110.

[0080] The engaging assembly 200, which clamps the support system 20, is loaded into the fifth engagement groove. During installation, the second hole segment is positioned above the first hole segment, such that the proximal end of the support 21 is positioned below the distal end. The lower end of the support system 20 is then connected to the mechanical testing machine in any suitable manner.

[0081] The mechanical testing machine is controlled to apply a tensile force until the balloon separates from the stent 21. The test data is recorded to obtain the removal force at the distal end of the stent.

[0082] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims of the present invention and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. A fixture for testing the force of bracket removal, characterized in that, The assembly includes a loading component and an engaging component, the engaging component being disposed on the loading component; the engaging component includes: A first engaging member has a first surface and a third surface, wherein a first slot is formed on the first surface; the third surface is at least partially opposite to the first surface; and a first engaging groove is provided on the third surface, wherein the first engaging groove is located at least on the portion of the third surface opposite to the first surface. The second engaging member has a second surface and a fourth surface, wherein a second slot is formed on the second surface; the fourth surface is at least partially opposite to the second surface; and a second engaging groove is provided on the fourth surface, wherein the second engaging groove is located at least on the portion of the fourth surface opposite to the second surface. The first engaging member and the second engaging member are rotatably connected to allow the first surface to separate from or at least partially abut against the second surface; the first slot and the second slot are assembled to form a mounting hole when the first surface and the second surface are at least partially abut against each other; The engaging assembly further includes a fastener, the fastener including a clamp, the clamp being configured to partially engage within the first engaging groove and apply a radially inward force along the first engaging hole to the first engaging member; the clamp is also configured to partially engage within the second engaging groove and apply a radially inward force along the second engaging member to the second engaging member, so that the first surface and the second surface remain in at least partially abutting.

2. The bracket removal force testing fixture according to claim 1, characterized in that, The clamp includes two interconnected clamp rods, each clamp rod having a free end away from the other clamp rod; one clamp rod is used to be at least partially disposed within the first engagement groove, and the other clamp rod is used to be at least partially disposed within the second engagement groove.

3. The bracket removal force testing fixture according to claim 2, characterized in that, The first engaging member includes a first main body and a first edge portion. There are two first edge portions, which are respectively connected to opposite sides of the first main body. The thickness of the first edge portion is less than the thickness of the first main body, and the thickness is the axial dimension of the first engaging member in the first slot. The second engaging component includes a second main body and a second edge portion. There are two second edge portions, which are respectively connected to opposite sides of the second main body. Each second edge portion is provided with a third engaging groove, which penetrates the second surface. Two second edge portions are provided in a one-to-one correspondence with two first edge portions; one first edge portion is at least partially accommodated in the third engagement groove of the corresponding second edge portion and is rotatably connected to the corresponding second edge portion, and the other first edge portion is at least partially accommodated in the third engagement groove of the corresponding second edge portion when the first surface and the second surface are at least partially abutted.

4. The bracket removal force testing fixture according to claim 3, characterized in that, The first edge portion is at least partially located on the same side of the first main body portion on the first preset plane, the first preset plane passing through the axis of the mounting hole and the rotation axis of the first engaging member and the second engaging member; The width of the portion of the first edge portion located on the same side of the first main body portion on the first preset plane decreases in the direction away from the first main body portion, and the width is the size of the first engaging member in the first preset direction, which is perpendicular to the arrangement direction of the first edge portion and the first main body portion. The portion of the third surface located in the first main body is arranged opposite to the first surface; The two ends of the first engagement groove extend to the two first edge portions respectively; The lever, which is at least partially disposed within the first engagement groove, is V-shaped.

5. The bracket removal force testing fixture according to claim 3, characterized in that, The second edge portion is at least partially located on the same side of the second main body portion on the second preset plane, the second preset plane passing through the axis of the second slot and the rotation axis of the second engaging member and the first engaging member; The width of the portion of the second edge portion located on the same side of the second main body portion on the second preset plane decreases in the direction away from the second main body portion. The width is the dimension of the second engaging member in the second preset direction, which is perpendicular to the arrangement direction of the second edge portion and the second main body portion. The portion of the fourth surface located on the second main body is arranged opposite to the second surface; The two ends of the second engagement groove extend to the two second edge portions respectively, and the lever for being at least partially disposed in the first engagement groove is V-shaped; and / or, the second engagement groove communicates with at least one of the third engagement grooves.

6. The bracket removal force testing fixture according to claim 1, characterized in that, The first surface is further provided with a first prepositioning element, and the second surface is further provided with a second prepositioning element; One of the first prepositioning member and the second prepositioning member is a protrusion, and the other is a recess.

7. The bracket removal force testing fixture according to claim 1, characterized in that, The mounting hole includes a first hole section, which is a tapered hole.

8. The bracket removal force testing fixture according to claim 1, characterized in that, The loading component includes a third main body, on which a fourth engagement groove and a fifth engagement groove are provided; The fourth engagement groove extends axially along the third main body and has a first opening through at least one end face of the third main body; the fourth engagement groove also has a second opening through one side face of the third main body. The fifth engagement groove includes two slots, which are aligned axially on the third main body and respectively disposed on opposite sides of the fourth engagement groove; the slots communicate with the fourth engagement groove; the slots also penetrate one side of the third main body and have a third opening, which is located on the same side of the third main body as the second opening.

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