Reduced volume conduit testing system and testing method

Abstract

The application discloses a kind of volume reduction conduit test system and test method, volume reduction conduit test system includes transmission shaft, volume reduction conduit test system includes main body, main body is equipped with power source and transmission assembly connected with power source, characterized in that, main body is also equipped with the mounting seat for detachably installing volume reduction conduit to be measured, mounting seat is connected with power source by transmission assembly, so that power source can drive mounting seat and transmission shaft installed on mounting seat to rotate.The volume reduction conduit test system and the corresponding test method provided by the application can not only simulate the actual working condition, real-time monitor the operation of volume reduction conduit, but also quickly replace the measured part, can replace different volume reduction conduit under the same working condition, and then can quickly confirm and select the required volume reduction conduit, avoid the problem that unstable causes operation failure or damage to patient due to volume reduction conduit not adapting to excessive torque requirement during operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a volume reduction catheter testing system and testing method. Background Technology

[0002] Arteriosclerosis obliterans (ASO) is a common and frequently occurring disease among middle-aged and elderly people, and it is also an important manifestation of atherosclerosis in the lower extremities.

[0003] Currently, treatment methods for lower extremity arteriosclerosis obliterans mainly include drug therapy, surgery, endovascular treatment, combined surgery, autologous peripheral blood stem cell transplantation, and gene therapy. Endovascular treatment for lower extremity arteriosclerosis obliterans has the advantages of being minimally invasive, safe, effective, and having a rapid recovery, and has become the first choice for the treatment of lower extremity arteriosclerosis obliterans. Current endovascular treatment methods include conventional percutaneous transluminal angioplasty (PTA) and the emerging endovascular volume reduction technique. PTA alone has significant limitations because simply dilating the stenotic segment cannot remove excess tissue, and it inevitably stretches the vessel wall, easily causing barotrauma and dissection, and postoperative rebound leading to restenosis. Therefore, PTA is usually used in combination with endovascular volume reduction. In endovascular volume reduction, intracutaneous mechanical plaque resection can remove plaque, and combined with PTA, it can achieve good therapeutic results. However, not all volume reduction catheters can effectively remove all plaques. When a volume reduction catheter removes a plaque by rotary cutting, the torque of the drive shaft of the volume reduction catheter is related to the resistance provided by the plaque, the rotation speed, and the diameter of the drive shaft. When the torque is too large, the drive shaft is prone to shaking, which will cause the blade to shake as well, thus affecting the normal removal of the plaque, and may even damage normal blood vessels due to shaking. Therefore, after confirming the size and location of the plaque before surgery, a suitable volume-reducing catheter should be tested and selected. However, current technologies mostly test the mechanical properties of the volume-reducing catheter, such as bending and torsional resistance, rather than conducting actual real-time testing. Existing technologies cannot actually confirm whether the current catheter is suitable for the current working conditions. Furthermore, existing technologies do not address the need to select different volume-reducing catheters based on different situations, and cannot identify the required volume-reducing catheter from multiple options. Therefore, a volume-reducing catheter testing system is needed that can replace different volume-reducing catheters under the same working conditions, thereby identifying and selecting the required catheter. This would solve the problem of unstable operation of the volume-reducing catheter during surgery due to its inability to adapt to excessive torque requirements, leading to surgical failure or patient injury. Summary of the Invention

[0004] Therefore, the present invention provides a volume reduction catheter testing system and testing method to solve the problem that the volume reduction catheter is unstable during operation due to its inability to adapt to excessive torque requirements, which in turn leads to surgical failure or damage to the patient.

[0005] The technical solution adopted in this invention is:

[0006] A volume reduction catheter testing system is provided for testing a volume reduction catheter under test. The volume reduction catheter under test includes a drive shaft. The volume reduction catheter testing system includes a main body, on which a power source and a transmission component connected to the power source are provided. The main body also has a mounting base for detachably mounting the volume reduction catheter under test. The mounting base is connected to the power source through the transmission component, so that the power source can drive the mounting base and the drive shaft mounted on the mounting base to rotate.

[0007] In one embodiment, the mounting base includes a sleeve, a collar, and a snap-fit ​​assembly, wherein the collar and the snap-fit ​​assembly are sequentially housed in the sleeve from the distal end to the proximal end. The mounting base also includes a channel extending through the sleeve, the collar, and the proximal end of the snap-fit ​​assembly along the length of the sleeve, the channel being used to place the drive shaft.

[0008] In one embodiment, the snap-fit ​​assembly includes a snap-fit ​​member and a connector, the snap-fit ​​member being located between the collar and the connector, and the outer wall of the connector being sealed to the inner wall of the sleeve.

[0009] In one embodiment, the distal end of the snap-fit ​​assembly includes a plurality of circumferentially distributed spring sheet structures, the free ends of the plurality of spring sheet structures or the inner surfaces of the spring sheet structures forming protrusions facing the longitudinal central axis of the snap-fit ​​assembly, and the inner diameter of the ring formed by the protrusions surrounding each other is smaller than the diameter of the channel.

[0010] In one embodiment, the proximal end of the collar includes a tapered cavity with an opening, and the distal end of the snap-fit ​​assembly is movably received within the tapered cavity.

[0011] In one embodiment, the distal end of the snap-fit ​​assembly is tapered, and the side of the distal end of the snap-fit ​​assembly abuts against the inner wall of the collar.

[0012] In one embodiment, the inner wall of the collar protrudes toward the longitudinal central axis of the collar.

[0013] In one embodiment, the distal surface of the connector abuts against the proximal surface of the clip, and the relative position of the connector and the sleeve is axially adjustable.

[0014] In one embodiment, the connector portion is inserted into the sleeve, and the proximal end face of the connector is closed, with the outer wall sealed to the inner wall of the sleeve.

[0015] A method for testing volume-reducing catheters is also provided, including the volume-reducing catheter testing system described above, with the following steps:

[0016] S1 Loosen the connector to move it a suitable distance toward the proximal end or remove the connector;

[0017] S2 will pass the drive shaft of the volume-reducing catheter to be tested through the channel sequentially through the distal end of the sleeve, the collar, and the clamp;

[0018] S3 Install the connector or adjust the connector to move it a suitable distance toward the distal end, and clamp the volume reduction conduit to be tested;

[0019] S4 increases the load on the reduced-volume catheter under test and simulates actual working conditions to detect real-time data;

[0020] After S5 test is completed, loosen the connector to move it toward the near end a suitable distance or remove the connector. The test ends. Proceed to step S6. If the test piece needs to be replaced, proceed to step S7.

[0021] S6 Remove the volume reduction catheter to be tested, and the process ends;

[0022] S7 Replace the volume reduction catheter to be tested and proceed to step S1.

[0023] Beneficial effects of the embodiments of the present invention:

[0024] This invention provides a volume reduction catheter testing system and method, including a mounting base for detachably mounting the volume reduction catheter to be tested. The mounting base drives the test piece to perform a rotary cutting function, which can not only simulate actual working conditions and monitor the operation of the volume reduction catheter in real time, but also quickly replace the test piece. Different volume reduction catheters can be replaced under the same working conditions, thereby quickly identifying and selecting the required volume reduction catheter. This avoids the problem of instability caused by the volume reduction catheter not adapting to excessive torque requirements during surgery, which may lead to surgical failure or damage to the patient. Attached Figure Description

[0025] Figure 1 This is a top view of the volume reduction catheter testing system in Embodiment 1 of the present invention;

[0026] Figure 2 This is a front view of the volume reduction catheter testing system in Embodiment 1 of the present invention;

[0027] Figure 3 along Figure 2 Partial cross-sectional view of plane AA;

[0028] Figure 4 This is a test schematic diagram of the volume reduction catheter in Embodiment 1 of the present invention;

[0029] Figure 5 This is a cross-sectional schematic diagram of the mounting base in Embodiment 1 of the present invention;

[0030] Figure 6 This is an exploded view of the mounting base in Embodiment 1 of the present invention;

[0031] Figure 7 This is a cross-sectional schematic diagram of the mounting base in Embodiment 2 of the present invention;

[0032] Figure 8 This is a schematic diagram of the working process of the volume reduction catheter in Embodiment 3 of the present invention. Detailed Implementation

[0033] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0034] In the description of this invention, if directional descriptions are involved, such as "up," "down," "front," "back," "left," "right," etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, it is only for the convenience of describing the invention and simplifying the description, and does 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 the invention. If a feature is referred to as "set," "fixed," or "connected" to another feature, it can be directly set, fixed, or connected to the other feature, or it can be indirectly set, fixed, or connected to the other feature.

[0035] In the description of the embodiments of the present invention, the term "several" means one or more, and the term "multiple" means two or more. The terms "greater than," "less than," and "exceeding" should be understood as excluding the stated number, while the terms "above," "below," and "within" should be understood as including the stated number. The terms "first" and "second" should be understood as distinguishing technical features, and not as indicating or implying relative importance, the number of indicated technical features, or the order of the indicated technical features.

[0036] Furthermore, unless otherwise defined, the technical and scientific terms used in the embodiments of this invention have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0037] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0038] Example 1

[0039] like Figure 1-2 As shown, Figure 1 This is a top view of the volume reduction catheter testing system 100 in Embodiment 1 of the present invention. Figure 2 This is a front view of the volume reduction catheter testing system 100 in Embodiment 1 of the present invention. The volume reduction catheter testing system 100 includes a main body 10, on which a power source 11 and a transmission assembly 12 are provided. In this embodiment, the power source 11 is a motor, and the transmission assembly 12 is a gear set. The gear set includes multi-stage gears, that is, the gear set includes a first stage 121 connected to the power source 11 and a second stage 122 connected to the device under test. The device under test (the volume reduction catheter under test) is detachably mounted on the second stage 122. After the device under test is installed, it is driven to move by the second stage 122. Specifically, the main body is provided with a mounting seat 13 and a separating seat 14. The device under test is fixed by the mounting seat 13 and connected to the second stage 122. The device under test 13 extends into the inner cavity of the separating seat 14 and leaves the main body 10 through the channel 141 of the separating seat 14. In accordance with the usual definition in the field of interventional medical devices, the right side of the accompanying drawings of this embodiment is the proximal side, and the left side is the distal side. After the plaque is cut at the distal end of the test piece, the cut tissue enters the inner cavity of the separation seat 14 along the channel 141 as the test piece rotates.

[0040] Power source 11 is connected to an encoder (not shown in the figure) that plays a control role. The encoder distributes a predetermined voltage and current to transmission component 12 to control the rotational speed of transmission component 12, and thus control the operating speed of the device under test (DUT). Conversely, when the DUT rotates at a predetermined speed, the encoder has corresponding voltage and current parameters. Therefore, by collecting the voltage and current data inside the encoder and comparing it with the no-load data when the DUT is not loaded, the load of the DUT can be monitored in real time. Specifically, the angular velocity of the second stage 122 is ω1, which corresponds to the angular velocity ω of the motor's main shaft satisfying ω=i·ω1, where i is the total transmission ratio of transmission system 12. When transmission system 12 and motor are determined, i is a constant. Then, the output torque T of the motor's main shaft satisfies T=P / ω, where P is the power. From the voltage U and current I monitored by the encoder, it can be derived that the output torque T of the motor's main shaft satisfies T=U·I / ω=U·I / (i·ω1). When the DUT is not loaded, the output torque T of the motor's main shaft satisfies T=U·I / ω=U·I / (i·ω1). The output torque is T. After the test piece (DPT) is loaded, it rotates together with the second stage 122, resulting in an angular velocity of ω1 for the DPT. To drive the DPT to rotate, the motor voltage becomes U' and the current becomes I'. Therefore, the output torque T' of the motor's main shaft becomes T' = U'·I' / (i·ω1). The difference between T' and T represents the load on the DPT. During the rotary cutting operation, the output power of the motor's main shaft continues to change, and the load change can be further monitored using an encoder. In general, the DPT is a rotary cutting device, and its load is directly proportional to the torque. When the DPT is in operation (i.e., rotary cutting a patch), there is resistance at the distal end of the DPT, and the load on the DPT is greater than in the non-operational state.

[0041] During the test, the distal end of the test piece needs to overcome a certain resistance when cutting the patch. It should be noted that different diameters and materials of the drive shaft of the test piece can affect the stability of the rotation of the test piece. The purpose of the volume reduction conduit test system 100 is to adapt to test pieces of different diameters and materials for testing.

[0042] Combination Figure 3-6 , Figure 3 It is along Figure 2 Partial cross-sectional view of plane AA in the middle. Figure 4 This is a test schematic diagram of the volume reduction catheter 20 in Embodiment 1 of the present invention. Figure 5 This is a cross-sectional schematic diagram of the mounting base 13 in Embodiment 1 of the present invention. Figure 6This is an exploded view of the mounting base 13 in Embodiment 1 of the present invention. For ease of distinction, the partition plates 101 and 102 on the main body 10 used for mounting and clamping are not shown in cross-section. The transmission system 12 is located between the partition plates 101 and 102. The second stage 122 serves as the final transmission gear of the transmission system 12, which drives the mounting base 13 to rotate as a whole. Therefore, the mounting base 13 is connected to the partition plate 101 through the rolling bearing 103, and the mounting base 13 is connected to the partition plate 101 through the rolling bearing 104.

[0043] For the volume reduction catheter 20 to be tested, the volume reduction catheter 20 includes a cutting section 21, a drive shaft 22 fixedly connected to the cutting section 21, and a sleeve 23 sleeved on the surface of the drive shaft 22. In actual operation, the plaque tissue cut by the cutting section 21 will detach from the blood vessel and gradually transport towards the proximal end of the volume reduction catheter 20 along the gap between the drive shaft 22 and the sleeve 23. During the testing process using the testing system, the cutting section 21 cuts a predetermined plaque, and the plaque tissue gradually transports towards the proximal end of the volume reduction catheter 20 along the gap between the drive shaft 22 and the sleeve 23.

[0044] For the separator 14, the separator 14 includes a channel 141 ( Figure 2 Specifically, channel 141 includes a first channel 1411 and a second channel 1412. The separation seat 14 also includes a receiving cavity 1413 and a discharge channel 1414. During the test, the tissue moving along the gap between the drive shaft 22 and the sleeve 23 passes through the first channel 1411 and the second channel 1412 in sequence, then enters the receiving cavity 1413, and is finally discharged through the discharge channel 1414. This is considered as normal operation of the volume reduction catheter 20.

[0045] Therefore, the storage cavity 1413 and the mounting base 13 are sealed. In this embodiment, a sealing ring 1011 is selected for sealing. Specifically, the sealing ring 1011 is located between the inner wall of the storage cavity 1413 and the rolling bearing 103.

[0046] Furthermore, the inner wall of the first channel 1411 is sealed to the outer wall of the sleeve 23. The sleeve 23 extends to the first channel 1411 and then stops extending. Since the testing system is for testing the stability of the cutting part 21 and the drive shaft 22, the sleeve 23 can be fixed at the second channel 1412 without replacement during testing. The drive shaft 22 passes through the first channel 1411 and the second channel 1412 until it is secured by the mounting base 13.

[0047] As for the mounting base 13, the mounting base 13 includes a sleeve 131, a collar 132, a retainer 133 and a connector 134. The mounting base 13 has a channel 135 along the axial direction. The channel 135 passes through the sleeve 131, the collar 132 and the retainer 133 in sequence. The channel 135 is used to place the drive shaft 22 of the volume reduction conduit 20 to be tested.

[0048] Specifically, the proximal end of the sleeve 131 is provided with a mounting cavity 1311, the collar 132 and the retainer 133 are installed inside the mounting cavity 1311, and the distal end of the connector 134 is installed inside the mounting cavity 1311. The outer surface of the collar 132 is cylindrical, and the interior includes a concave, open, hollow conical cavity. That is, the inner wall 1321 of the collar 132 is a concave structure, and the diameter of the cross-section of the concave structure decreases from the proximal end to the distal end of the collar 132 along the axial direction. In other words, the inner wall 1321 of the collar 132 gradually approaches the axis from the proximal end to the distal end along the axial direction. The distal end of the clamp 133 is provided with multiple spring clip structures 1331. The spring clip structures 1331 are distributed circumferentially, and the proximal end of the spring clip structure 1331 is fixed on the clamp 133, while the distal end is a free end. In the natural state, the free end of the spring clip structure 1331 protrudes in the axial direction to form a protrusion 1332. Then, the distal ends of the multiple spring clip structures 1331 converge, and the inner diameter of the ring formed by the protrusions 1332 is smaller than the diameter of the channel 135. This allows the spring clip structure 1331 to naturally clamp the drive shaft 22 of the volume reduction conduit 20 to be tested, and to remain clamped even when the diameter of the drive shaft 22 changes.

[0049] However, since the drive shaft 22 needs to rotate, relying solely on the elasticity of the spring structure 1331 to fix the clamp 133 and the drive shaft 22 is not reliable enough. Therefore, it is also necessary to partially insert the spring structure 1331 of the clamp 133 into the inside of the collar 132 from the proximal end to the distal end. The outer side of the free end of the spring structure 1331 abuts against the inner wall 1321 of the collar 132, and the inner side abuts against the drive shaft 22. The free end of the spring structure 1331 presses against the drive shaft 22, thus achieving a reliable connection between the clamp 133 and the drive shaft 22.

[0050] In order to make the free end of the spring structure 1331 fit more precisely with the inner wall 1321 of the collar 132, the free end of the spring structure 1331 is provided with a tapered surface, and the tapered surface is tightly attached to the inner wall of the collar 132.

[0051] Furthermore, as the inner wall 1321 of the collar 132 gradually approaches the axis from the proximal end to the distal end along the axial direction, when the spring structure 1331 of the clamp 133 moves along the inner wall, the distance between the free ends of the multiple spring structures 1331 changes with the relative position of the clamp 133 and the collar 132. This achieves the function that the clamp 133 and the collar 132 can always clamp the transmission shaft 22 when dealing with different diameters of the transmission shaft 22.

[0052] To prevent test tissue from leaking out of the mounting base 13, the proximal end of the clip 133 is sealed to the inner wall of the mounting cavity 1311 by a seal 1312.

[0053] For connector 134, connector 134 and locking member 133 combine to form locking assembly 135. The distal end of connector 134 abuts against the proximal end of locking member 133, thereby pressing locking member 133 toward collar 132, and then confining locking member 133 and collar 132 inside receiving cavity 1311. The position of connector 134 relative to receiving cavity 1311 can be adjusted by adjusting partition plate 102, that is, partition plate 102 is axially adjustable, and the proximal end of connector 134 abuts against the surface of partition plate 102. In this embodiment, channel 135 passes through connector 134. To prevent test tissue from seeping out of mounting base 13, the inner wall of connector 134 is sealed to the outer surface of drive shaft 22 by an annular silicone strip.

[0054] Furthermore, the connector 134 is threaded to the inner wall of the receiving cavity 1311, so that the relative positional relationship between the collar 132 and the retainer 133 can be adjusted directly by adjusting the connector 134.

[0055] In another embodiment, the channel 135 does not penetrate or reach the connector 134, that is, the proximal end face of the connector 134 is closed, and the distal end face is closed or open (to accommodate a part of the drive shaft of the test piece). The outer wall of the connector 134 is sealed with the mounting cavity 1311. With this setting, it is only necessary to ensure that the connector 134 abuts against the clamp 133 to limit the clamp 133, without having to consider the sealing problem between the connector 134 and the drive shaft 22.

[0056] In another embodiment, the connector 134 and the locking piece 133 are an integral structure. The spring plate structure 1331 of the locking piece 133 is threadedly engaged with the inner wall 1321 of the collar 132. That is, by rotating the connector 134, the relative position of the locking piece 133 and the collar 132 along the axial direction can be adjusted, thereby changing the distal inner diameter of the locking piece 133.

[0057] In summary, when using the testing system 100 provided in this embodiment for testing, first remove or loosen the connector 134 to move it a suitable distance toward the near end. Then, the drive shaft 22 of the test piece passes through the first channel 1411 and the second channel 1412 in sequence, and passes through the sleeve 131, collar 132, and clamp 133 in sequence along the channel 135 (when there is a channel on the connector 134, the drive shaft 22 also enters or passes through the connector 134). Then, install the connector 134 or adjust the connector 134 to move it a suitable distance toward the far end to complete the installation of the test piece. Then, add load to the test piece and simulate actual working conditions, detect real-time data, and after the test is completed, remove or loosen the connector 134 to move it a suitable distance toward the near end, remove the test piece to complete the test, or replace the test piece to perform another round of testing.

[0058] The testing system 100 provided in this embodiment can not only check whether a single test piece has quality defects, but also quickly replace and select the appropriate volume reduction conduit according to different actual situations.

[0059] Example 2

[0060] The same content as in Example 1 will not be repeated here. The difference is that the inner wall of the collar in Example 2 is curved. See [link to example]. Figure 7 As shown, Figure 7 This is a cross-sectional schematic diagram of the mounting base 33 in Embodiment 2 of the present invention. The inner wall 3321 of the collar 332 is an arc surface. Specifically, along the axial direction, from the near end to the far end, the inner wall 3321 of the collar 332 gradually approaches the axis, and the inner wall 3321 protrudes in the axial direction.

[0061] The collar 332 configured in this way can further clamp the drive shaft of the test piece 333. Specifically, for test pieces of the same diameter, when the pressure between the clamp and the test piece is the same, the distance from the proximal end face of the collar 332 to the proximal end face of the clamp 333 in this embodiment is less than the distance from the proximal end face of the collar 132 to the proximal end face of the clamp 133 in Embodiment 1.

[0062] Example 3

[0063] The contents of Example 3 are the same as those of Example 1 and will not be repeated. The difference is that in Example 3, the collar is threaded to the inner wall of the mounting cavity. After the clamp is tightly pressed against the collar, rotation can drive the collar to rotate and move axially along the inner wall of the mounting cavity. Furthermore, the connecting component in Example 3 is an elastic structure (such as a rubber plug), the purpose of which is to allow for adjustable axial relative position between the drive shaft and the mounting seat. This example is for a special type of volume-reducing conduit, such as... Figure 8 As shown, Figure 8 This is a schematic diagram of the operation of the volume reduction catheter 40 in Embodiment 3. The volume reduction catheter 40 includes a coaxially assembled cutting head 401, a limiting member 402, and a first sleeve 403. The cutting head 401 is the main working component for cutting and transporting excess tissue. The limiting member 402 is rotatably connected to the cutting head 401 and can axially limit the cutting head 401. The distal end of the limiting member 402 engages with the proximal end of the cutting head 401 and can rotate relative to it. Furthermore, the limiting member 402 can further decompose the tissue transported by the cutting head 401. The first sleeve 403 is fitted onto the proximal end of the cutting head 401. This serves two purposes: firstly, to prevent the proximal end of the cutting head 401 from rotating and cutting normal blood vessel walls or normal tissue; and secondly, to limit the radial displacement of the cutting head 401, i.e., to radially limit the cutting head 401.

[0064] The proximal end of the cutting head 401 is provided with multiple through grooves 4013, each through groove 4013 penetrating the cutting edge 4011 circumferentially and connecting to the adjacent conveying groove 4012. The distal end of the limiting member 402 is provided with multiple disintegration members 4021 near the end, each disintegration member 4021 being a boss shape, protruding inward from the inner wall of the limiting member 402, and the multiple disintegration members 4021 are spaced apart circumferentially along the limiting member 402. When the cutting head 401 rotates, the disintegration members 4021 alternately enter the through grooves 4013 and the conveying grooves 4012, colliding with the tissue within the conveying grooves 4012 and disintegrating it into smaller tissue volumes. In this embodiment, the multiple disintegration members 4021 move simultaneously, alternately passing through the multiple through grooves 4013 and the corresponding multiple conveying grooves 4012, resulting in high processing efficiency.

[0065] The first sleeve 403 is fitted over the outside of the blade head 401. It not only restricts the radial displacement of the blade head 401 itself, but also, after the blade head 401 cuts and captures the narrowed tissue in the blood vessel distal to the blade head 401, the cut tissue is transported along the delivery channel 4012 from the distal end to the proximal end of the volume-reducing catheter 40. The first sleeve 403 also prevents the cut tissue from directly leaving the delivery channel 4012 of the blade head 401 radially. In other words, the first sleeve 403, in conjunction with the blade head 401, causes the captured narrowed tissue to move proximally along the delivery channel 4012, realizing the instrument's function of cutting and transporting the tissue. Specifically, the first sleeve 403 covers the proximal portion of the blade head 401 and the distal portion of the limiting member 402.

[0066] The axial width L1 of the disassembly component 4021 and the axial width L2 of the through groove 4013 in the cutter head 401 can be set to different values. That is, the axial position of the disassembly component 4021 in the through groove 4013 can change. The axial width L1 of the disassembly component 4021 is less than the axial width L2 of the through groove 4013. The volume-reducing conduit 40 has an axial extension length change (L2-L1) along the axial direction. By adjusting the axial distance between the proximal end of the disassembly component 4021 and the proximal end of the through groove 4013, the extension amount of the cutter head 401 from the first sleeve 403 is changed. When the volume-reducing conduit 40 does not include the first sleeve 403, by adjusting the axial distance between the proximal end of the disassembly component 4021 and the proximal end of the through groove 4013, the axial distance from the distal end of the cutter head 401 to the distal end of the limiting component 402 is changed. In essence, regardless of whether the reducing conduit 40 includes the first sleeve 403, the axial distance between the proximal end of its adjusting disassembly member 4021 and the proximal end of the through groove 4013 is the axial distance between the distal end of the adjusting tip 401 and the distal end of the limiting member 402. Therefore, the tip 401 has at least two different extension lengths relative to the limiting member 402 or the first sleeve 403. When the extension length is at its maximum, the distal portion of the blade 401 used for cutting is the largest, and the cutting ability of the blade 401 is the strongest. At this time, the distal end of the disassembly element 4021 abuts against the distal end of the through groove 4013. In this state, the volume-reducing catheter 40 is suitable for cutting severe, coaxial calcified lesions. When the extension length is at its minimum, the distal portion of the blade 401 used for cutting is the smallest, and the cutting ability of the blade 401 is relatively weakest. At this time, the proximal end of the disassembly element 4021 abuts against the proximal end of the through groove 4013. In this state, the volume-reducing catheter 40 is suitable for cutting curved, irregular lesions.

[0067] By adjusting the relative position of the drive shaft to the mounting base, the axial position of the disassembled component within the through groove can be adjusted, thereby enabling the detection of the cutting status when the same volume-reducing catheter is used to cut different lesion locations.

[0068] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

[0069] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present invention, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application. Furthermore, unless otherwise specified, the embodiments of the present invention and the features described therein can be combined with each other.

Claims

1. A volume-reducing conduit testing system for performing torque testing on a volume-reducing conduit under test, wherein the volume-reducing conduit under test includes a drive shaft, and the volume-reducing conduit testing system includes a main body, wherein the main body is provided with a power source and a transmission assembly connected to the power source, characterized in that, The main body is provided with a mounting base and a separation base; the mounting base is connected to the power source through the transmission assembly, so that the power source can drive the mounting base and the transmission shaft mounted on the mounting base to rotate, wherein the power source is connected to an encoder that plays a control role, and the encoder distributes a predetermined voltage and current to the transmission assembly to control the rotational speed of the transmission assembly; The mounting base includes a sleeve, a collar, and a snap-fit ​​assembly. From the distal end to the proximal end, the collar and the snap-fit ​​assembly are sequentially housed in the sleeve. The mounting base also includes a channel that passes through the sleeve, the collar, and the proximal end of the snap-fit ​​assembly along the length of the sleeve. The channel is used to place the drive shaft. The proximal end of the collar includes a conical cavity with an opening, and the distal end of the snap-fit ​​assembly is movably received inside the conical cavity; the distal end of the snap-fit ​​assembly is conical, and the side of the distal end of the snap-fit ​​assembly abuts against the inner wall of the collar. The separation seat includes a first channel, a second channel, a receiving cavity, and a discharge channel; The drive shaft of the volume-reducing conduit to be tested passes sequentially through the first channel, the second channel of the separation seat, and the channel of the mounting seat, and can be detachably installed on the mounting seat.

2. The volume reduction catheter testing system according to claim 1, characterized in that, The snap-fit ​​assembly includes a snap-fit ​​component and a connector. The snap-fit ​​component is located between the collar and the connector, and the outer wall of the connector is sealed to the inner wall of the sleeve.

3. The volume reduction catheter testing system according to claim 1, characterized in that, The distal end of the snap-fit ​​assembly includes multiple circumferentially distributed spring sheet structures. The free ends of the multiple spring sheet structures or the inner surfaces of the spring sheet structures form protrusions facing the longitudinal central axis of the snap-fit ​​assembly. The inner diameter of the ring formed by the protrusions surrounding each other is smaller than the diameter of the channel.

4. The volume reduction catheter testing system according to claim 1, characterized in that, The inner wall of the collar protrudes towards the longitudinal central axis of the collar.

5. The volume reduction catheter testing system according to claim 2, characterized in that, The distal surface of the connector abuts against the proximal surface of the clip, and the relative position of the connector and the sleeve is axially adjustable.

6. The volume reduction catheter testing system according to claim 5, characterized in that, The connector is partially inserted into the sleeve, and the proximal end face of the connector is closed, while the outer wall is sealed to the inner wall of the sleeve.

7. A method for testing a volume-reducing catheter, comprising the volume-reducing catheter testing system as described in any one of claims 2, 5, and 6, comprising the following steps: S1 Loosen the connector to move it a suitable distance toward the proximal end or remove the connector; S2 will pass the drive shaft of the volume-reducing catheter to be tested through the channel sequentially through the distal end of the sleeve, the collar, and the clamp; S3 Install the connector or adjust the connector to move it a suitable distance toward the distal end, and clamp the volume reduction conduit to be tested; S4 increases the load on the reduced-volume catheter under test and simulates actual working conditions to detect real-time data; After S5 test is completed, loosen the connector to move it toward the proximal end a suitable distance or remove the connector. The test ends. Proceed to step S6. If the test piece needs to be replaced, proceed to step S7. S6 Remove the volume reduction catheter to be tested, and the process ends; S7 Replace the volume reduction catheter to be tested and proceed to step S1.

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