CN111789700A

CN111789700A - Valve function testing device

Info

Publication number: CN111789700A
Application number: CN202010608802.6A
Authority: CN
Inventors: 吕守良; 吴帅辉
Original assignee: Chengdu Serano Medical Technology Co ltd
Current assignee: Chengdu Celano Medical Technology Co ltd
Priority date: 2020-06-30
Filing date: 2020-06-30
Publication date: 2020-10-20
Anticipated expiration: 2040-06-30
Also published as: CN111789700B

Abstract

The invention discloses a valve function testing device, comprising: cylinder body mechanism, actuating mechanism and piston assembly, cylinder body mechanism includes: the heart valve prosthesis comprises a mounting seat arranged in a first cylinder body and used for mounting a prosthetic heart valve, and a bottom cover arranged at one end of the first cylinder body, wherein the inner wall of the first cylinder body is matched with the bottom cover to form a first cavity, and a driving mechanism drives a piston assembly to reciprocate in the first cavity; the piston assembly is provided with a one-way valve capable of sealing the first cavity; a return passage communicating with both ends of the first chamber; when the piston assembly moves towards the side close to the prosthetic heart valve, the one-way valve is closed, the prosthetic heart valve is opened, and the test solution flows back through the backflow passage; when the piston assembly moves away from the side of the prosthetic heart valve, the prosthetic heart valve is closed, the check valve is opened, and the test liquid flows through the check valve and then fills the space between the piston assembly and the prosthetic heart valve. The invention can simplify the structure of the valve function testing equipment and improve the testing accuracy of the valve function testing equipment.

Description

Valve function testing device

Technical Field

The invention relates to the technical field of medical equipment testing equipment, in particular to valve function testing equipment.

Background

Valvular heart disease is a common heart disease. Currently, for most patients with valvular diseases, an effective treatment option is to perform a prosthetic heart valve (or prosthetic heart valve) replacement procedure, which works with a prosthetic heart valve instead of the diseased valve. The quality of the valve is directly related to the safety of a patient, so after the valve is produced, various performance indexes of the valve need to be tested and evaluated.

Chinese patent application CN106716098A discloses a "system for testing valves", comprising: a proximal chamber portion defining a proximal interior space, a distal chamber portion defining a distal interior space merging with the proximal interior space, a valve holder disposed between the proximal and distal interior spaces, the valve holder configured to receive the valve in a bore of the valve holder, the valve holder including one or more return flow apertures.

During testing, the liquid can move up and down in the chamber through the actuator, when the liquid moves up, the valve is opened, the liquid flows through the backflow holes on the valve and the valve support, and the liquid flows from the lower part to the upper part of the chamber; when the liquid moves downward, the valve closes, the liquid flows through the return orifice and returns to the lower portion of the chamber. Accelerated life testing of prosthetic heart valves is possible with the system. The accelerated life test, also known as an accelerated wear test or endurance test, is used to study materials, design concepts, design modifications, and changes in endurance due to manufacturing technology changes.

At present, although there are some devices for testing and evaluating the performance index of the valve in the prior art, there are still some more or less to be improved.

Disclosure of Invention

In order to overcome at least one defect in the prior art, the invention provides a valve function testing device, which can improve the testing accuracy of the valve function testing device while simplifying the structure of the valve function testing device.

The above object of the present invention can be achieved by the following technical solutions:

a valve function testing device comprising: cylinder body mechanism, actuating mechanism and piston assembly, cylinder body mechanism includes: the heart valve prosthesis comprises a first cylinder body, a mounting seat arranged in the first cylinder body and used for mounting a prosthetic heart valve, and a bottom cover arranged at one end of the first cylinder body, wherein the inner wall of the first cylinder body is matched with the bottom cover to form a first cavity, and the first cavity is provided with a first end close to the bottom cover and a second end far away from the bottom cover; the drive mechanism is configured to drive the piston assembly to reciprocate in the first cavity; the piston assembly is provided with a one-way valve capable of sealing the first cavity; a return passage communicating the first and second ends.

Further, the cylinder mechanism further comprises a second cylinder, the second cylinder is sleeved on the periphery of the first cylinder, a second cavity is formed between the second cylinder and the first cylinder, and the second cavity is communicated with the first end and the second end of the first cavity respectively to form the backflow passage.

Further, the top of the second cylinder is higher than the top of the first cylinder, and the cylinder mechanism further comprises a top cover which is arranged on the top of the second cylinder in a sealing mode.

Further, the bottom cover is in sealing fit with the second cylinder body, and a notch for communicating the first cavity with the second cavity is formed in one end, close to the bottom cover, of the first cylinder body.

Furthermore, a partition plate is arranged between the outer wall of the first cylinder body and the inner wall of the second cylinder body, and a circulation hole is formed in the partition plate.

Further, the piston assembly has a threshold position during movement adjacent the prosthetic heart valve side, a pressure sensor being disposed between the threshold position and the prosthetic heart valve.

Further, the bottom cover is hermetically connected with a first end of the first cavity, a first communication hole is formed in the first cavity at a position close to the first end, a second communication hole is formed in the first cavity at a position above the mounting seat, and the return passage is configured to: at least one connection pipe disposed between the first and second communication holes.

Further, the check valve on the piston assembly is a check valve capable of adjusting the opening pressure.

Furthermore, the check valve capable of adjusting the opening pressure comprises a pressing cap and a valve seat which are detachably connected, and a spring, a spring block and a valve core which are sequentially arranged between the pressing cap and the valve seat, wherein the spring is abutted between the pressing cap and the spring block, the valve core is fixed in the valve seat, a second opening communicated with the first cavity is formed in the end face of the valve core, the spring block is intermittently abutted with the valve core under the hydraulic action, and the second opening is opened or closed so as to open or close the check valve.

Furthermore, the one-way valve capable of adjusting the opening pressure comprises a pressing cap and a valve seat which are detachably connected, and a spring and a valve core which are sequentially arranged between the pressing cap and the valve seat, wherein the end face of the valve core is a plugging end, the spring is abutted between the pressing cap and the valve core, and the valve core is intermittently abutted with the valve seat under the hydraulic action so as to open or close the one-way valve.

Further, the valve seat comprises an upper valve seat and a lower valve seat which are detachably connected, a threaded hole is formed in the upper valve seat, and an external thread section matched with the threaded hole is formed on the outer side wall of the pressing cap.

Further, the piston assembly further comprises a piston rod, the cylinder mechanism further comprises a bearing, and the piston rod is connected with the bottom cover through the bearing.

Further, the cylinder mechanism further includes: the water-stop sheet is arranged in the bottom cover; the first sealing ring is positioned between the top cover and the second cylinder body, the second sealing ring is positioned between the first cylinder body and the second cylinder body, and the third sealing ring is positioned between the second cylinder body and the bottom cover; and the U-shaped seal is positioned between the piston rod and the bottom cover.

Further, the valve function testing apparatus further comprises a ring for being disposed between the mount and the prosthetic heart valve.

The valve function testing device provided by the embodiment of the application integrates the one-way valve on the piston assembly, and forms a testing device with a compact structure by utilizing the return passage which is matched and arranged by the cylinder mechanism (the cylinder mechanism only needs at least one cylinder). During testing, along with the reciprocating linear movement of the piston assembly, the switching states of the one-way valve and the prosthetic heart valve are changed alternately to form a testing cycle; in addition, for a single test process, when the piston assembly moves towards the prosthetic heart valve side, the liquid for pushing the prosthetic heart valve to open and do work is completely separated from the backflow passage, and the liquid and the backflow passage are not influenced with each other, so that the piston assembly can conveniently establish stable positive pressure at the lower side (namely the position to be tested) of the prosthetic heart valve; when the piston assembly moves away from the side of the prosthetic heart valve, stable negative pressure can be established on the lower side of the prosthetic heart valve under the condition that the moving speed of the piston assembly is stable, namely, stable positive pressure and negative pressure can be formed on the lower side of the prosthetic heart valve in a single test process, so that the actual biological environment can be accurately simulated. On the whole, this valve function test equipment is overall structure compactness, liquid model are simple not only, are convenient for carry out accurate control to pressure moreover to can accurate simulation actual biological environment.

Drawings

The invention is further described with reference to the following figures and embodiments.

Fig. 1 is a perspective view of a valve function testing apparatus provided in an embodiment of the present application;

FIG. 2 is a partial cross-sectional view of a valve function testing apparatus provided in an embodiment of the present application;

fig. 3 is a perspective view of a cylinder mechanism provided with a piston assembly in the valve function testing apparatus provided in the embodiment of the present application;

FIG. 4 is an exploded view of a cylinder mechanism and piston assembly provided in an embodiment of the present application;

FIG. 5A is a schematic illustration of fluid flow within a cylinder during movement of a piston assembly provided in an embodiment of the present application in a first cylinder adjacent a prosthetic heart valve;

FIG. 5B is a schematic illustration of fluid flow within a cylinder during movement of a piston assembly provided in an embodiment of the present application away from a prosthetic heart valve in a first cylinder;

fig. 6 is an exploded view of a first cylinder provided in an embodiment of the present application;

fig. 7 is an exploded view of a bottom cover provided in an embodiment of the present application;

FIG. 8A is a cross-sectional view of a piston assembly provided in an embodiment of the present application;

FIG. 8B is an exploded view of a piston assembly provided in an embodiment of the present application;

FIG. 8C is an exploded view of a check valve provided in an embodiment of the present application;

FIG. 9 is a top view of a piston assembly provided in an embodiment of the present application;

FIG. 10A is a cross-sectional view A-A of the piston assembly with the check valve closed as provided in the embodiments of the present application;

FIG. 10B is a cross-sectional view B-B of the piston assembly with the check valve open as provided in the embodiments of the present application;

fig. 11 is a schematic distribution diagram of a sealing mechanism in a cylinder mechanism provided in an embodiment of the present application;

FIG. 12 is a cross-sectional view of a press cap provided in an embodiment of the present application;

FIG. 13A is a front view of a lower valve seat provided in an embodiment of the present application;

FIG. 13B is a rear view of a lower seat provided in an embodiment of the present application;

FIG. 13C is a cross-sectional C-C view of a lower valve seat provided in an embodiment of the present application;

FIG. 13D is a D-D cross-sectional view of a lower valve seat provided in an embodiment of the present application;

FIG. 14 is a perspective view of a valve cartridge provided in an embodiment of the present application;

FIG. 15 is a cross-sectional view of another piston assembly provided in an embodiment of the present application;

FIG. 16 is a perspective view of a valve cartridge in the piston assembly provided in FIG. 15;

FIG. 17A is a cross-sectional view A-A of the piston assembly with the check valve provided in FIG. 15 in an open state;

FIG. 17B is a cross-sectional view B-B of the piston assembly with the check valve provided in FIG. 15 in a closed state;

fig. 18 is a perspective view of another valve function testing apparatus provided in an embodiment of the present application;

fig. 19 is a partial cross-sectional view of fig. 18.

Description of reference numerals:

100. a cylinder mechanism; 120. a first cylinder; 1101. a second drain hole; 110. a second cylinder; 121. a partition plate; 1210. a flow-through hole; 122. a notch; 101. liquid level; 103. a pressure sensor; 130. a bottom cover; 1301. a first drain hole; 140. a mounting seat; 141. a ring; 150. a top cover; 102. a return path; 161. a first seal ring; 162. a second seal ring; 163. a third seal ring; 170. a water-stop sheet; 180. u-shaped sealing; 190. a bearing;

200. a drive mechanism; 210. a motor; 220. a screw rod pushing cylinder;

300. a piston assembly; 310. a one-way valve; 311. pressing the cap; 3110. an external threaded section; 3111. a first opening; 312. an upper valve seat; 313. a spring; 314. a spring block; 315. a valve core; 3151. a second opening; 3150. plugging the end; 3152. a lateral flow aperture; 316. a valve seal ring; 317. a lower valve seat; 3172. a third opening; 3171. a fourth opening; 318. a first screw; 320. a piston seal ring; 331. a second screw; 332. a piston rod;

400. a supporting seat; 401. a support table; 402. a second support cylinder; 403. a first support cylinder;

500. a prosthetic heart valve.

Detailed Description

The technical solutions of the present invention will be described in detail with reference to the accompanying drawings and specific embodiments, it should be understood that these embodiments are merely illustrative of the present invention and are not intended to limit the scope of the present invention, and various equivalent modifications of the present invention by those skilled in the art after reading the present invention fall within the scope of the appended claims.

It will be understood that when an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 to 2 together, in an embodiment of the present disclosure, a valve function testing apparatus is provided, which mainly includes: cylinder mechanism 100, drive mechanism 200, piston assembly 300.

In this embodiment, the cylinder mechanism 100 is used to simulate the biological environment in which the prosthetic heart valve 500 is located. At the time of testing, the cylinder mechanism 100 contains a test liquid (hereinafter, referred to simply as a liquid). The prosthetic heart valve 500 is mounted in a test fluid in the cylinder mechanism 100.

The driving mechanism 200 serves to drive the piston assembly 300 to reciprocate linearly in the cylinder mechanism 100. Specifically, as shown in fig. 2, the driving mechanism 200 may include a motor 210 and a lead screw cylinder 220. The lead screw cylinder 220 may include a rotational input end and a linear output end. The motor 210 is connected to the input end of the lead screw pushing cylinder 220, and the output end of the lead screw pushing cylinder 220 is connected to the piston assembly 300. The rotating motor 210 drives the input end of the lead screw pushing cylinder 220 to rotate. The lead screw cylinder 220 converts the rotational motion of the input end into a linear motion of the output end, so that the output end of the lead screw cylinder 220 drives the piston assembly 300 to move linearly. The motor 210 rotates forward and backward alternately, so that the reciprocating linear motion of the piston assembly 300 can be realized. The driving mechanism 200 may also be a hydraulic cylinder or an air cylinder, or may also be an electromagnetic mechanism capable of performing linear motion, such as a linear motor 210, a voice coil motor 210, etc., and the specific form of the driving mechanism 200 is not specifically limited herein.

Taking the valve function testing apparatus shown in fig. 1 and 2 as an example, the piston assembly 300 is located in the cylinder mechanism 100 and on the lower side of the prosthetic heart valve 500, and the piston assembly 300 can be driven by the driving mechanism 200 to move up and down repeatedly. During the reciprocating up and down movement of the piston assembly 300, the test fluid in the cylinder mechanism 100 is caused to cyclically flow along a predetermined path toward the prosthetic heart valve 500, periodically opening or closing the prosthetic heart valve 500, thereby serving to test the function of the prosthetic heart valve 500.

Referring to fig. 2, fig. 3 and fig. 4, the cylinder mechanism 100 provided by the present application may mainly include: the second cylinder 110, the first cylinder 120, the bottom cover 130, and the mounting base 140.

The second cylinder 110 may have a hollow cylindrical shape. Specifically, the second cylinder 110 may have a cylindrical shape with two open ends, and of course, the second cylinder 110 may have other regular or irregular thin-walled hollow structures, and the application is not limited in this respect. The second cylinder 110 has opposite upper and lower sides. Wherein, a bottom cover 130 is provided at a lower side of the second cylinder 110, and the bottom cover 130 is used for sealing the lower end opening of the second cylinder 110.

Referring to fig. 6, the first cylinder 120 may also be hollow and cylindrical. Specifically, the first cylinder 120 may have a cylindrical shape with two open ends, and similarly, the first cylinder 120 may also have other regular or irregular thin-walled hollow structures, and the application is not limited in this respect. Taking the second cylinder 110 and the first cylinder 120 as cylindrical shapes, the inner diameter of the second cylinder 110 is larger than the outer diameter of the first cylinder 120, the first cylinder 120 is disposed inside the second cylinder 110, and an annular gap is formed between the inner wall of the second cylinder 110 and the outer wall of the first cylinder 120.

Further, a mount 140 is provided in the first cylinder block 120. The mount 140 is for receiving a prosthetic heart valve 500 to be tested. Specifically, the mounting seat 140 may be disposed at an upper side of the first cylinder 120, near the top, to facilitate installation and subsequent replacement operations.

Additionally, a ring 141 may also be disposed between the mount 140 and the prosthetic heart valve 500. In particular, prosthetic heart valves 500 of different specifications match the ring 141 of a corresponding specification. The ring 141 acts as an attachment flange to facilitate testing of different sizes of prosthetic heart valves 500 using the same testing equipment.

In the present embodiment, the bottom cover 130 forms a cavity for accommodating liquid together with the second cylinder 110 and the first cylinder 120. Specifically, the inner wall of the first cylinder 120 cooperates with the bottom cover 130 to form a first chamber. The first cavity has a first end proximate the bottom cover 130 and a second end facing away from the bottom cover 130. Further, since the cavity sidewall of the first cavity is formed by the first cylinder 120, the first and second ends of the first cavity coincide with the first and second ends of the first cylinder 120. The inner wall of the second cylinder 110 cooperates with the outer wall of the first cylinder 120 and the bottom head 130 to form a second chamber.

In this embodiment, the second chamber communicates with the top and bottom of the first chamber to form a circulation loop for the test solution. It should be noted that: the top and bottom of the second chamber and the first chamber are opposite concepts, generally referring to the opposite ends of the second chamber and the first chamber. As shown in fig. 2, when the cylinder mechanism 100 in the valve function test apparatus is disposed entirely in the height direction, the two end portions of the second chamber and the first chamber are a top portion and a bottom portion that are opposed to each other in the height direction. The relative positions of the piston assembly 300 and the mounting base 140 in the height direction may be interchanged. In the present description, the embodiments with the piston assembly 300 on the bottom and the mounting base 140 on the top are mainly explained, and the embodiments with the piston assembly 300 mounted on the bottom of the mounting base 140 are not excluded. Further, when the cylinder mechanism 100 in the valve function test apparatus is disposed entirely in the horizontal direction, both end portions of the second chamber and the first chamber are left and right end portions in the horizontal direction.

The driving mechanism 200 drives the piston assembly 300 to reciprocate in the first chamber. The piston assembly 300 is provided with a check valve 310 that seals off the first chamber. As shown in fig. 5A, when the piston assembly 300 moves toward the side close to the prosthetic heart valve 500, the check valve 310 is closed, the piston assembly 300 pushes the test fluid toward the prosthetic heart valve 500, the prosthetic heart valve 500 is opened, and the test fluid flows back through the second chamber into the first chamber below the check valve 310; as shown in FIG. 5B, when the piston assembly 300 is moved away from the prosthetic heart valve 500, the prosthetic heart valve 500 is closed, the check valve 310 is opened, and the fluid under the first chamber flows through the check valve 310 to fill the space between the piston assembly 300 and the prosthetic heart valve 500, completing one cycle of the test fluid.

Specifically, as shown in fig. 4, the lower side of the first cylinder 120 may be provided with at least one communication portion. The communicating portion may be a notch 122 formed in the lower side wall of the first cylinder 120, and the test liquid returned from the second chamber can be returned to the first chamber through the notch 122. When the prosthetic heart valve 500 is opened, the second lumen, the gap 122, to the first lumen below the one-way valve 310 forms a backflow passage 102 for backflow. During the backflow of the fluid through the backflow passage 102, the check valve 310 on the piston assembly 300 is in a closed state, and the fluid for pushing the prosthetic heart valve 500 to open is completely isolated from the backflow passage 102, i.e., the fluid flowing in the backflow passage 102 is not mixed with the fluid in the first chamber for opening the prosthetic heart valve 500, and the backflow fluid does not interfere with the fluid pressure on the lower side of the prosthetic heart valve 500, so that a stable fluid pressure can be obtained on the lower side of the prosthetic heart valve 500. In addition, when the piston assembly 300 moves downward, the check valve 310 opens, and by controlling the moving speed of the piston assembly 300, a stable negative pressure can be formed on the underside of the prosthetic heart valve 500, i.e., the negative pressure is not disturbed by other fluids during the movement of the piston assembly 300. The underside of the prosthetic heart valve 500 is capable of developing a stable hydraulic pressure throughout the testing process to facilitate accurate simulation of the actual biological environment.

Further, the cylinder mechanism 100 may be further provided with a top cover 150. Specifically, the head cover 150 may be sealingly disposed on the top of the second cylinder 110. The top of the second cylinder 110 is higher than the top of the first cylinder 120. During testing, the fluid level 101 in the second cylinder 110 exceeds the prosthetic heart valve 500 located on the mount 140.

The valve function testing device provided by the embodiment of the application is provided with two layers of cavities (a second cavity and a first cavity), wherein the second cavity is respectively communicated with two ends of the first cavity to form a backflow passage 102; also, a prosthetic heart valve 500 and a piston assembly 300 having a one-way valve 310 are disposed in the first lumen. When the piston assembly 300 moves towards the side close to the prosthetic heart valve 500, the check valve 310 is closed, the piston assembly 300 pushes the test solution to flow towards the prosthetic heart valve 500, the prosthetic heart valve 500 is opened, and the test solution flows back to the check valve 310 through the backflow passage 102 to the first cavity close to the first end; when the piston assembly 300 moves away from the prosthetic heart valve 500, the prosthetic heart valve 500 is closed, the check valve 310 is opened, the test fluid flowing back into the first chamber flows through the check valve 310 to fill the space between the piston assembly 300 and the prosthetic heart valve 500, and the test process is repeated, so that a plurality of cyclic tests can be performed. This test may be used to determine whether the prosthetic heart valve 500 is functioning properly, i.e., opening and closing properly. The use of the testing device also enables prediction of the useful life of the prosthetic heart valve 500 when the cycling test meets the fatigue test criteria requirements.

In general, the valve function testing apparatus provided in the embodiments of the present application, when tested, completely isolates the backflow passage 102 from the fluid used to push the prosthetic heart valve 500 to open, and both do not affect each other, thereby facilitating the piston assembly 300 to establish a stable working environment at the underside of the valve. As the piston assembly 300 moves upward, a positive pressure is established on the upper side of the piston assembly 300; when piston assembly 300 moves down, establish the negative pressure between piston assembly 300 upside and valve downside, on the whole, the liquid model is simple, and interference factor is few, is convenient for carry out accurate control to pressure.

In this embodiment, the valve function testing apparatus may further include a support base 400, and the support base 400 is used to support and fix the cylinder mechanism 100 and the driving mechanism 200. Specifically, the composition and structure of the support base 400 can be adaptively selected and designed according to the specific assembly requirements and the like of the driving mechanism 200 and the like. As shown in fig. 2, the support seat 400 may include: a support table 401, a first support cylinder 403 and a second support cylinder 402. Wherein the support table 401 includes a support panel and a plurality of support legs for supporting the support panel. The support panel has opposite upper and lower surfaces, wherein the first and

second support cylinders

403 and 402 may be mounted on the upper surface of the support panel. The first supporting cylinder 403 is used for installing the screw rod pushing cylinder 220, the upper end of the first supporting cylinder is fixedly connected with the bottom cover 130, and the lower end of the first supporting cylinder is fixedly connected with the second supporting cylinder 402. The second supporting cylinder 402 is used for connecting the part of the motor 210, and the inner side of the upper end thereof is fixedly connected with the first supporting cylinder 403, and the lower end thereof is fixed on the supporting panel. The middle of the supporting panel is provided with a mounting hole for penetrating the motor 210.

As shown in fig. 8A and 8B, in some embodiments, to meet different fluid pressure test requirements, a check valve 310 on the piston assembly 300 may be provided as a check valve 310 that can adjust the cracking pressure. By arranging the check valve 310 capable of adjusting the opening pressure, the valve function testing equipment can rapidly adjust a detection environment meeting the testing requirements in the debugging process.

Referring to fig. 8C and 9 in combination, the adjustable cracking pressure check valve 310 may include: a pressure cap 311, a valve seat, a spring 313, a spring block 314, a valve core 315 and a valve sealing ring 316.

Wherein, the pressing cap 311 is detachably connected with the valve seat. The spring 313 is disposed between the pressing cap 311 and the valve seat, and the amount of compression of the spring 313 can be changed by adjusting the depth of the pressing cap 311 in the valve seat.

Specifically, the valve seat may include a removably attached upper valve seat 312 and lower valve seat 317. The detachable connection may be a threaded connection, but may also be another connection, such as a snap connection. For example, the upper valve seat 312 and the lower valve seat 317 may be coupled by a first screw 318.

In one embodiment, the manner of adjusting the depth of the pressure cap 311 in the valve seat may be a threaded adjustment. Specifically, a threaded hole is provided in the upper valve seat 312, and as shown in fig. 12, an external threaded section 3110 matching with the threaded hole is formed on the outer side wall of the pressing cap 311. The amount of compression of spring 313 can be adjusted up or down by screwing in or out the depth of gland 311 in the threaded hole. When the piston assembly 300 moves away from the prosthetic heart valve 500, the amount of compression of the spring 313 is positively correlated to the pressure under the prosthetic heart valve 500, since the amount of compression of the spring 313 is positively correlated to the opening pressure of the check valve 310. By adjusting the amount of compression of spring 313, the fluid pressure on the underside of prosthetic heart valve 500 as piston assembly 300 moves away from the side of prosthetic heart valve 500 meets the test requirements.

The upper valve seat 312 may be a hollow cavity, and a pressure cap 311, a spring 313, a spring block 314, and a valve core 315 are sequentially accommodated in the hollow cavity of the upper valve seat 312 from top to bottom. The lower end of the valve body 315 abuts against the lower valve seat 317, the valve body 315 is fixed in the lower valve seat 317, and both ends of the spring 313 abut against the pressure cap 311 and the spring block 314, respectively. Spring block 314 is pressed downwardly by spring 313. The spring block 314 is subjected to different hydraulic pressures as the piston assembly 300 moves upward and downward. The spring block 314 intermittently abuts against the valve body 315 under the combined action of the pressure of the spring 313 and the different liquid pressure, and accordingly the check valve 310 is intermittently closed, that is, the open/closed state is switched.

In the test, as shown in fig. 10A, when the piston assembly 300 moves upward in the first cylinder 120, the hydraulic pressure on the upper side of the piston assembly 300 is greater than the hydraulic pressure on the lower side of the piston assembly 300, the spring block 314 is acted by the downward pressure of the spring 313 and the downward hydraulic pressure, the spring block 314 abuts against the valve core 315, the check valve 310 is closed, and the liquid passage is cut off. As shown in fig. 10B, when piston assembly 300 moves downward in first cylinder 120, the hydraulic pressure on the lower side of piston assembly 300 is greater than the hydraulic pressure on the upper side of piston assembly 300, spring block 314 is simultaneously acted on by the downward pressure of spring 313 and the upward hydraulic pressure, and when the upward hydraulic pressure is greater than the downward pressure of spring 313, the hydraulic pressure pushes spring block 314 to move upward to compress spring 313 until the upward hydraulic pressure is equal to the downward pressure of spring 313, and spring block 314 stops moving. When the fluid pressure pushes the spring block 314 upward, the one-way valve 310 opens and fluid can pass from the underside of the piston assembly 300 through a hole in the middle of the piston assembly 300 to the upper side of the piston assembly 300, filling the space between the piston assembly 300 and the prosthetic heart valve 500.

Referring to fig. 12, 13A, 13B, 13C, 13D and 14, a hole for allowing liquid to pass through is formed among the pressing cap 311, the valve core 315 and the lower valve seat 317. Specifically, as shown in fig. 12, the middle of the pressing cap 311 is provided with a first opening 3111; as shown in fig. 14, the second opening 3151 is provided in the middle of the end surface of the spool 315. As shown in fig. 13A, 13B, 13C, 13D, the lower valve seat 317 has first and second opposing surfaces, wherein the first surface is centrally provided with a central hole, and the first surface is further provided with a plurality of third openings 3172 disposed around the central hole. The second surface is provided inwardly with a fourth opening 3171 communicating with the third opening 3172. When the check valve 310 is in the open state, the first bore 3111, the second bore 3151, the third bore 3172, and the fourth bore 3171 communicate; on the contrary, when the check valve 310 is in the closed state, the second opening 3151 of the valve core 315 is blocked by the spring block 314 and cannot communicate with the first opening 3111.

Further, as shown in fig. 7 and 8B, the cylinder mechanism 100 may further include a bearing 190. The bearing 190 is disposed in the bottom cover 130. Specifically, the bottom cover 130 may be a hollow solid of revolution, the inner wall of which is formed with a circular cavity for mounting the bearing 190, and the outer wall of which is formed with at least one groove for mounting the sealing ring.

In addition, the piston assembly 300 further includes a piston rod 332. The piston rod 332 may be detachably coupled to the lower valve seat 317 by a second screw 331. With further reference to fig. 2, the piston rod 332 is connected to the bottom cover 130 through a bearing 190, so as to realize circumferential limiting and fixing of the piston rod 332.

Further, as shown in fig. 2, 6, and 7, a partition 121 is disposed between a middle portion of an outer wall of the first cylinder 120 and an inner wall of the second cylinder 110. The partition plate 121 is provided with a flow hole 1210 through which a fluid flows. Specifically, the partition 121 and the first cylinder 120 may be integrally formed, but may be connected by a fixed connection. The second cylinder 110 and the water stop plate 170 are connected by gluing or the like, but may be detachably connected by other methods, for example, the water stop plate 170 and the second cylinder 110 are detachably connected by bolts. In addition, in order to further fix the first cylinder 120, the first cylinder 120 and the bottom cover 130 may be detachably coupled by bolts.

The second cylinder 110 and the first cylinder 120 can be integrated by the partition 121, so that the first cylinder 120 is supported, and the piston assembly 300 is supported and secured to move up and down in the first cylinder 120, thereby enhancing the stability of the system.

Further, as shown in fig. 4, the bottom cover 130 may further be provided with a first drain hole 1301. Correspondingly, the second cylinder 110 is correspondingly provided with a second water discharge hole 1101 matched with the first water discharge hole 1301. In the test, sealing plugs may be provided in the first and

second drain holes

1301 and 1101. After the test is finished, the sealing plug can be opened, so that the first drainage hole 1301 and the second drainage hole 1101 are opened, and the liquid in the second cavity and the first cavity is drained.

Further, as shown in fig. 2, 7, and 11, the cylinder mechanism 100 further includes a water stop plate 170. The water blocking plate 170 is disposed in the bottom cover 130 and serves as a sealing gasket for the bottom cover 130. Specifically, the shape of the water-stop sheet 170 may match the internal structure of the bottom cover 130, and the material thereof may be PTFE.

Further, the cylinder mechanism 100 may also include other sealing mechanisms including: a first sealing ring 161 between the top cap 150 and the second cylinder 110, a second sealing ring 162 between the second cylinder 110 and the first cylinder 120, and a third sealing ring 163 between the second cylinder 110 and the bottom cap 130; a U-shaped seal 180 between piston rod 332 and bottom cap 130.

In general, by providing the above-mentioned sealing mechanism, the top cover 150 forms a sealed cavity together with the second cylinder 110 and the bottom cover 130 for containing liquid, so that the cylinder mechanism 100 becomes a liquid-tight enclosure.

Further, in order to observe whether the valve leaflets of the prosthetic heart valve 500 are normally opened or closed during the test, the top cover 150, the second cylinder 110, and the first cylinder 120 may be made of transparent materials.

Further, the cylinder mechanism 100 may further include a pressure sensor 103. As shown in fig. 2, the piston assembly 300 has a critical position during movement adjacent the prosthetic heart valve 500 side. This critical position may be the highest position of piston assembly 300 when piston assembly 300 moves up and down. In the following, the critical position is mainly taken as the highest position for example, and in other cases, for example, the critical position is the lowest position, or the leftmost position, the rightmost position, and the like, analog reference can be made, and the description of the present application is omitted here.

The pressure sensor 103 is arranged between the highest position and the prosthetic heart valve 500, and the installation position of the pressure sensor 103 is the position to be measured. Through set up pressure sensor 103 in cylinder body mechanism 100, can be used for detecting the liquid pressure of prosthetic heart valve 500 downside department (be the pressure position that awaits measuring promptly), be convenient for match corresponding diastolic pressure and systolic pressure to simulate real biological pressure environment, follow-up can be according to pressure sensor 103 to measure liquid pressure, compare with test environment pressure target value, according to the comparative value, adjust pressure cap 311, thereby adjust test environment pressure, form closed loop control.

Referring to fig. 15 and 16 in combination, another piston assembly 300 is provided in the present embodiment, and the piston assembly 300 of this embodiment is structurally different from the piston assembly 300 of the previous embodiment in a portion of the valve element 315. In the process of closing the check valve 310, the valve core 315 is mainly matched with the lower valve seat 317 and the valve sealing ring 316 positioned between the lower valve seat 317 and the lower valve seat.

Specifically, in the present embodiment, the end surface of the valve body 315 is a stopper end 3150, the second opening 3151 is not provided in the middle, and a plurality of side flow holes 3152 are formed in the side wall of the valve body 315 in the circumferential direction. When the piston assembly 300 is at rest, the valve core 315 is pressed by the pressing cap 311, the spring 313 and the spring block 314 to abut against the lower valve seat 317, and is sealed by the valve sealing ring 316, so that the one-way valve 310 is closed. The spring 313 indirectly abuts against the valve core 315 through the spring block 314, the spring block 314 can better conduct the force of the spring 313 to the valve core 315, and compared with the direct abutting without the spring block 314, the contact area between the spring block 314 and the valve core 315 is larger, and the stress of the valve core 315 is more uniform.

Referring to fig. 17A, when the piston assembly 300 moves downward, the valve core 315 overcomes the pre-tightening force of the spring 313 under the action of the lower hydraulic pressure, so as to push the spring block 314 and the spring 313 to move upward integrally, the check valve 310 is opened, and the test fluid flows upward through the lateral flow hole 3152 on the side of the valve core 315. When the fluid pressure is great enough, the spool 315 will abut the upper seat 312 and the check valve 310 will fully open. Referring to fig. 17B, when the piston assembly 300 moves upward, the valve core 315 is in sealing engagement with the lower valve seat 317 through the valve sealing ring 316 under the action of the liquid pressure and the pre-tightening force of the spring 313, and the check valve 310 is closed.

Referring to fig. 18 and 19 in combination, another valve function testing device is provided in an embodiment of the present application, which also includes: cylinder mechanism 100, drive mechanism 200, piston assembly 300. In the present description, the structural differences from the above embodiments are mainly described, and other parts, such as specific testing processes, corresponding technical effects, etc., please refer to the detailed description of the above embodiments, which will not be described herein again.

In the present embodiment, the form of the return passage 102 is mainly different from that of the above-described embodiment. In particular, the first chamber has opposing first and second ends. Wherein the bottom cover 130 is hermetically connected with the first end of the first cavity. A cap 150 may be sealingly connected to the second end of the first chamber. A first communication hole is formed at a position of the first chamber close to the first end, a second communication hole is formed at a position of the first chamber above the mounting seat 140, and at least one connection pipe is arranged between the first communication hole and the second communication hole to form the return passage 102.

Wherein, the number of the connecting pipes can be one or more. When the number of the connecting pipes is multiple, the connecting pipes can be evenly distributed along the circumferential direction of the first cavity at intervals.

The valve function testing apparatus provided in the embodiment of the present application integrates the check valve 310 on the piston assembly 300, and uses the cylinder mechanism 100, wherein the cylinder mechanism 100 only needs one cylinder at least, and the return passage 102 is provided to form a compact testing apparatus. During testing, along with the reciprocating linear movement of the piston assembly 300, the on-off states of the one-way valve 310 and the prosthetic heart valve 500 are changed alternately to form a testing cycle; and for a single test process, when the piston assembly 300 moves towards the prosthetic heart valve 500, the liquid for pushing the prosthetic heart valve 500 to open and do work is completely isolated from the backflow passage 102, and the two do not affect each other, so that the piston assembly 300 can establish stable positive pressure at the lower side (namely the position to be measured) of the prosthetic heart valve 500, and when the piston assembly 300 moves away from the prosthetic heart valve 500, stable negative pressure can be established at the lower side of the prosthetic heart valve 500 under the condition that the moving speed of the piston assembly 300 is stable, namely, in the test process, the lower side of the prosthetic heart valve 500 can form stable positive pressure and negative pressure, so as to accurately simulate the actual biological environment. On the whole, this valve functional test equipment is overall structure compactness not only, the liquid model is simple, is convenient for carry out accurate control to pressure moreover to can accurate simulation actual biological environment, thereby obtain accurate test data.

It should be noted that, in the description of the present application, the terms "first", "second", and the like are used for descriptive purposes only and for distinguishing similar objects, and no precedence between the two is intended or should be construed to indicate or imply relative importance. In addition, in the description of the present application, "a plurality" means two or more unless otherwise specified.

The above embodiments in the present specification are all described in a progressive manner, and the same and similar parts among the embodiments may be referred to each other, and each embodiment is described with emphasis on being different from other embodiments.

The above description is only a few embodiments of the present invention, and although the embodiments of the present invention are described above, the above description is only for the convenience of understanding the present invention, and is not intended to limit the present invention. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A valve function testing apparatus, comprising: a cylinder mechanism, a driving mechanism and a piston assembly,

the cylinder mechanism includes: the heart valve prosthesis comprises a first cylinder body, a mounting seat arranged in the first cylinder body and used for mounting a prosthetic heart valve, and a bottom cover arranged at one end of the first cylinder body, wherein the inner wall of the first cylinder body is matched with the bottom cover to form a first cavity, and the first cavity is provided with a first end close to the bottom cover and a second end far away from the bottom cover;

the drive mechanism is configured to drive the piston assembly to reciprocate in the first cavity; the piston assembly is provided with a one-way valve capable of sealing the first cavity;

a return passage communicating the first and second ends.

2. The valve function testing apparatus of claim 1, wherein the cylinder mechanism further comprises a second cylinder, the second cylinder is disposed around the first cylinder, a second cavity is formed between the second cylinder and the first cylinder, and the second cavity is communicated with the first end and the second end of the first cavity to form the backflow passage.

3. The valve function testing apparatus of claim 2, wherein a top of the second cylinder is higher than a top of the first cylinder, the cylinder mechanism further comprising a cap sealingly disposed at the top of the second cylinder.

4. The valve function testing apparatus of claim 2, wherein the bottom cap is in sealing engagement with the second cylinder, and the first cylinder is provided with a notch at an end proximate the bottom cap that communicates with the first and second chambers.

5. The valve function testing apparatus of claim 4, wherein a partition is disposed between an outer wall of the first cylinder and an inner wall of the second cylinder, and a flow hole is disposed on the partition.

6. The valve function testing apparatus of claim 3, wherein the piston assembly has a threshold position during movement adjacent a prosthetic heart valve side, a pressure sensor being disposed between the threshold position and the prosthetic heart valve.

7. The valve function testing apparatus of claim 1, wherein the bottom cap is sealingly coupled to a first end of the first chamber, the first chamber is provided with a first communication hole proximate the first end, the first chamber is provided with a second communication hole above the mounting seat, and the return channel is configured to: at least one connection pipe disposed between the first and second communication holes.

8. The valve function testing apparatus of claim 1, wherein the one-way valve on the piston assembly is an adjustable cracking pressure one-way valve.

9. The valve function testing device of claim 8, wherein the check valve with the adjustable opening pressure comprises a pressing cap and a valve seat which are detachably connected, and a spring, a spring block and a valve core which are sequentially arranged between the pressing cap and the valve seat, wherein the spring is abutted between the pressing cap and the spring block, the valve core is fixed in the valve seat, a second opening communicated with the first cavity is formed in the end face of the valve core, and the spring block is intermittently abutted with the valve core under the action of hydraulic pressure to open or close the second opening so as to open or close the check valve.

10. The valve function testing device of claim 8, wherein the check valve with the adjustable opening pressure comprises a pressing cap and a valve seat which are detachably connected, and a spring and a valve core which are sequentially arranged between the pressing cap and the valve seat, wherein the end surface of the valve core is a blocking end, the spring is abutted between the pressing cap and the valve core, and the valve core is intermittently abutted with the valve seat under the hydraulic action so as to open or close the check valve.

11. The valve function testing device of claim 9 or 10, wherein the valve seat comprises an upper valve seat and a lower valve seat which are detachably connected, a threaded hole is arranged in the upper valve seat, and an external threaded section matched with the threaded hole is formed on the outer side wall of the pressing cap.

12. The valve function testing apparatus of claim 1, wherein the piston assembly further comprises a piston rod, the cylinder mechanism further comprising a bearing, the piston rod being coupled to the bottom cap via the bearing.

13. The valve function testing apparatus of claim 3, wherein the cylinder mechanism further comprises: the water-stop sheet is arranged in the bottom cover; the first sealing ring is positioned between the top cover and the second cylinder body, the second sealing ring is positioned between the first cylinder body and the second cylinder body, and the third sealing ring is positioned between the second cylinder body and the bottom cover; and the U-shaped seal is positioned between the piston rod and the bottom cover.

14. The valve function testing apparatus of claim 1, further comprising an annulus for disposition between the mount and the prosthetic heart valve.