Catheter sheath activating device

Abstract

A catheter sheath activation device includes a translation mechanism and a test mechanism. The translation mechanism comprises a base, a sliding body and a driving assembly, the sliding body is slidably connected to the base, the driving assembly is arranged on the base, and the driving assembly is in transmission connection with the sliding body so as to drive the sliding body to translate along the base. The testing mechanism is provided with a catheter sheath clamp and a force sensor, and the force sensor is connected with the catheter sheath clamp and used for measuring external force borne by the catheter sheath clamp. When the catheter sheath activation device activates detection, firstly, the catheter sheath clamp is used for clamping the dilator, then the driving assembly operates to drive the catheter sheath clamp to move, the dilator slowly retracts along the catheter sheath, and tension generated in the process can be transmitted to the force sensor. When the tension value displayed by the force sensor is within a certain range, the catheter sheath is good in smoothness, and the product is qualified. And in the aspect of clinical application, the device has the advantages that the product consistency is good, the operation difficulty of medical personnel is small, and the risk of hurting a patient can be reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a catheter sheath activation device. Background Technology

[0002] The catheter sheath 4, also known as the sheath tube, is primarily used to establish a passage and guide catheters, balloon catheters, or other intravascular devices smoothly into the blood vessel. It consists of the sheath body 41, connector 43, dilator 42, and short guidewire. (See...) Figure 1 As shown. The sheath body 41 is a thin-walled soft tube, and the dilator is located inside the sheath body. The dilator is a rigid tube. In clinical use, the dilator supports the catheter sheath to enter the patient's skin tissue, and then the dilator is withdrawn, leaving the catheter sheath in the body for subsequent surgery.

[0003] During the removal of the dilator, it is pulled out from inside the sheath. This presents a problem: since the sheath encloses the dilator, there is some resistance due to friction between the inner wall of the sheath and the outer wall of the dilator when removing it. Because both the dilator and the catheter sheath are made of plastic tubing, there may be tolerances in the manufacturing process. These tolerances can lead to inconsistent tightness between the dilator and the sheath. Furthermore, since catheter sheaths are currently assembled manually, the force applied by each person during manual assembly varies, making it difficult to determine a suitable tightness. This results in inconsistent tightness of the produced catheter sheaths.

[0004] In existing technologies, after catheter sheath assembly, an activation test, commonly known as patency testing, is performed. This test involves inserting a dilator into the catheter sheath and testing its patency. This process requires high precision, and currently, activation testing is primarily conducted manually based on feel or using a cylinder for tension testing. These methods are highly inefficient and struggle to guarantee consistent force output, especially since the force applied by each person holding the dilator varies, making it difficult to ensure consistent patency across all catheter sheaths. Therefore, it's impossible to determine whether the manufactured catheter sheaths are up to standard. This increases the difficulty of operation for medical staff in clinical use and may even pose a risk of harm to patients. How to conduct activation testing to ensure consistent patency across manufactured catheter sheaths is a pressing problem that needs to be solved.

[0005] In view of the above, this utility model is hereby proposed. Utility Model Content

[0006] To address one of the aforementioned technical deficiencies, this utility model provides a catheter sheath activation device.

[0007] This application provides the following technical solution:

[0008] A catheter sheath activation device, comprising:

[0009] A translation mechanism, comprising a base, a slider, and a drive assembly, wherein the slider is slidably connected to the base, the drive assembly is disposed on the base, and the drive assembly and the slider are pulsatorically connected to drive the slider to translate along the base;

[0010] The testing mechanism is disposed on the sliding body. The testing mechanism has a catheter sheath clamp and a force sensor. The force sensor is connected to the catheter sheath clamp and is used to measure the external force on the catheter sheath clamp.

[0011] Optionally, the testing mechanism includes a mounting base and a slide rail disposed on the mounting base;

[0012] The mounting base is connected to the sliding body;

[0013] The catheter sheath clamp is slidably connected to the slide rail;

[0014] The force sensor is fixed to the mounting base, and the force sensor and the catheter sheath clamp are connected by a force transmission shaft.

[0015] Optionally, the mounting base is provided with a mounting plate;

[0016] The mounting plate is located at one end of the slide rail along its length.

[0017] The force sensor is mounted on the mounting plate;

[0018] The force transmission shaft is located between the mounting plate and the catheter sheath clamp, and both ends of the force transmission shaft are connected to the mounting plate and the catheter sheath clamp, respectively.

[0019] Optionally, the mounting plate includes a main board body and side platforms disposed on both sides of the main board body;

[0020] The side platform is detachably connected to the mounting base by fasteners;

[0021] The mainboard body is perpendicular to the mounting base;

[0022] The force sensor is connected to the motherboard.

[0023] Optionally, the catheter sheath clamp includes a support and a clamping assembly;

[0024] The support is slidably connected to the slide rail;

[0025] The clamping assembly is disposed on the support, and the support is provided with a mating platform on the side near the force sensor;

[0026] Both the mating platform and the force sensor have threaded grooves;

[0027] Both ends of the force transmission shaft are provided with external threads, and the two ends of the force transmission shaft are respectively threaded to the threaded grooves on the mating platform and the force sensor.

[0028] Optionally, the clamping assembly includes a finger cylinder and two grippers;

[0029] The finger cylinder includes a cylinder body and two sliders disposed on the cylinder body;

[0030] The cylinder body is connected to the support, and the two grippers are respectively connected to the corresponding sliders;

[0031] The finger cylinder can drive two sliders to move the two grippers closer together or further apart to perform gripping or releasing actions.

[0032] Optionally, a clamping notch is provided on one side of the two grippers facing each other;

[0033] When the two sliders are close together, the clamping notches on the two grippers connect to form a bayonet.

[0034] Optionally, the gripper includes a first extension and a second extension;

[0035] The first extension is connected to the slider;

[0036] The second extension is vertically connected to the first extension, and the clamping notch is provided on the side of the second extension away from the first extension.

[0037] Optionally, a stop is provided along the edge of the support;

[0038] The baffles enclose a concave cavity, and the baffles are provided with a clearance opening that communicates with the concave cavity;

[0039] The cylinder body is partially embedded in the recessed cavity, and the air pipe connecting the finger cylinder extends through the clearance notch.

[0040] Optionally, the drive assembly includes a motor and a lead screw;

[0041] The lead screw is rotatably mounted on the base;

[0042] The sliding body has a threaded groove, and the lead screw is threadedly connected to the threaded groove of the sliding body;

[0043] The motor and the lead screw are connected.

[0044] By adopting the above technical solution, this application has the following beneficial effects:

[0045] The catheter sheath activation device of this application first clamps the dilator using a catheter sheath clamp during activation testing. Then, a drive assembly moves the catheter sheath clamp, causing the dilator to slowly retract along the catheter sheath. The tension generated during this process is transmitted to a force sensor. When the force sensor displays a tension value within a certain range, it indicates that the catheter sheath has good flowability and is a qualified product. In clinical applications, its advantages lie in good product consistency, ensuring ease of operation for medical personnel, and reducing the risk of harm to patients. Attached Figure Description

[0046] The accompanying drawings, which form part of this application, are used to provide a further understanding of the present invention. The illustrative embodiments and descriptions of the present invention are used to explain the present invention, but do not constitute an undue limitation of the present invention. Obviously, the drawings described below are merely some embodiments, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0047] Figure 1 This is a schematic diagram of the structure of the catheter sheath activation device clamping the catheter sheath provided in the embodiments of this disclosure;

[0048] Figure 2 A schematic diagram of the test mechanism of the catheter sheath activation device provided in this embodiment of the present disclosure;

[0049] Figure 3 This is a schematic diagram of the structure of the baffle of the catheter sheath activation device provided in an embodiment of the present disclosure;

[0050] Figure 4 This is a schematic diagram of the cylinder body of the catheter sheath activation device provided in the embodiments of this disclosure;

[0051] Figure 5 This is a schematic diagram of the gripper structure of the catheter sheath activation device provided in an embodiment of this disclosure;

[0052] Figure 6 This is a schematic diagram of the slider of the catheter sheath activation device provided in an embodiment of this disclosure.

[0053] In the diagram: Translation mechanism 1, base 11, slider 12, drive assembly 13, motor 131, lead screw 132, reducer 133, coupling 134, testing mechanism 2, catheter sheath clamp 21, support 211, support body 2111, stop 21111, clearance notch 21111a, slider 2112, clamping assembly 212, finger cylinder 2121, cylinder body 21211, slide groove 21211a, slider 21212, slider body 21212a, extension 21212b, fifth connecting hole 21212b1, gripper 2 122, First extension 21221, Sixth connecting hole 21221a, Second extension 21222, Clamping notch 21222a, Mating platform 213, Main platform 2131, Side platform 2132, Third connecting hole 2132a, Force sensor 22, Mounting base 23, Slide rail 24, Force transmission shaft 25, Mounting plate 26, Main body 261, Side platform 262, First connecting hole 2621, Sheath fixing assembly 3, Sheath mounting plate 31, Connecting seat cylinder 32, Connecting seat clamp 33, Catheter sheath 4, Sheath body 41, Expander 42, Connecting seat 43. Detailed Implementation

[0054] To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions in the embodiments will be clearly and completely described below with reference to the accompanying drawings. The following embodiments are used to illustrate the present utility model, but are not intended to limit the scope of the present utility model.

[0055] In the description of this utility model, it should be noted that the terms "upper", "lower", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0056] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0057] See Figures 1 to 6As shown, this disclosure provides a catheter sheath activation device, including a translation mechanism 1 and a testing mechanism 2. The translation mechanism 1 includes a base 11, a slider 12, and a drive assembly 13. The slider 12 is slidably connected to the base 11, and the drive assembly 13 is disposed on the base 11. The drive assembly 13 and the slider 12 are connected in a transmission manner to drive the slider 12 to translate along the base 11. The testing mechanism 2 is disposed on the slider 12 and has a catheter sheath clamp 21 and a force sensor 22. The force sensor 22 is connected to the catheter sheath clamp 21 and is used to measure the external force acting on the catheter sheath clamp 21. During activation detection, the catheter sheath activation device of this application first clamps the dilator 42 using the catheter sheath clamp 21. Then, the drive assembly 13 operates to move the catheter sheath clamp 21, causing the dilator 42 to slowly retract along the catheter sheath 4. The tensile force generated during this process is transmitted to the force sensor 22. When the force sensor 22 displays a tension value within a certain range, it indicates that the catheter sheath 4 has good flowability and is a qualified product. In clinical applications, its advantages lie in its good product consistency, ensuring easy operation for medical personnel and reducing the risk of harm to patients.

[0058] The testing mechanism 2 includes a mounting base 23 and a slide rail 24 disposed on the mounting base 23. The mounting base 23 is connected to the sliding body 12. The catheter sheath clamp 21 is slidably connected to the slide rail 24. The force sensor 22 is fixed to the mounting base 23. The force sensor 22 and the catheter sheath clamp 21 are connected via a force transmission shaft 25. The sliding resistance between the catheter sheath clamp 21 and the slide rail 24 is very small and can be ignored during activation detection. Thus, during the operation of the drive assembly 13 to move the catheter sheath clamp 21, the catheter sheath clamp 21 and the slide rail 24 will have adaptive slight displacements according to the magnitude of the external force, which will not affect the tensile force value detected by the sensor 22.

[0059] In one possible implementation, a mounting plate 26 is provided on the mounting base 23, located at one end of the slide rail 24 along its length, and the force sensor 22 is mounted on the mounting plate 26. A force transmission shaft 25 is located between the mounting plate 26 and the catheter sheath clamp 21, with both ends of the shaft connected to the mounting plate 26 and the catheter sheath clamp 21, respectively. The mounting plate 26 is vertically connected to the slide rail 24, and the force transmission shaft 25 connects the mounting plate 26 and the catheter sheath clamp 21 and is parallel to the slide rail 24. During the operation of the drive assembly 13 to move the catheter sheath clamp 21, the tension force on the catheter sheath clamp 21 is evenly transmitted to the force transmission shaft 25, and then to the force sensor 22. This ensures the accuracy of the tension force detected by the force sensor 22.

[0060] The mounting plate 26 includes a main body 261 and side platforms 262 disposed on both sides of the main body 261. The side platforms 262 are detachably connected to the mounting base 23 by fasteners (not shown). The main body 261 is perpendicular to the mounting base 23, and the force sensor 22 is connected to the main body 261. A first connecting hole 2621 is provided on the side platform 262, and a second connecting hole (not shown) is provided on the mounting base 23. The fasteners can be bolts and nuts. When the mounting plate 26 is connected to the mounting base 23, the bolt shank passes through the first connecting hole 2621 and the second connecting hole and is threadedly connected to the nut. The bolt head and the nut are located on both sides of the side platform 262 and the mounting base 23. The height of the side platform 262 is lower than the height of the main body 261, and an installation space for fasteners is formed between the side platform 262 and the main body 261, facilitating the installation and removal of the mounting plate 26.

[0061] In one possible implementation, the catheter sheath clamp 21 includes a support 211 and a clamping assembly 212. The support 211 is slidably connected to the slide rail 24, and the clamping assembly 212 is disposed on the support 211. A mating platform 213 is provided on the side of the support 211 near the force sensor 22. Both the mating platform 213 and the force sensor 22 have threaded grooves. Both ends of the force transmission shaft 25 are provided with external threads, and the two ends of the force transmission shaft are respectively threaded to the threaded grooves on the mating platform 213 and the force sensor 22. The support 211 includes a support body 2111 and a sliding block 2112, and the sliding block 2112 is slidably connected to the slide rail 24. The clamping assembly 212 is connected to the side of the support body 2111 opposite to the sliding block 2112. The mating platform 213 has a main platform body 2131 and side platforms 2132 disposed on both sides of the main platform body 2131. The threaded groove of the mating platform 213 is disposed on the main platform body 2131. The side platforms 2132 are detachably connected to the support body 2111 by fasteners (not shown). The height of the side platforms 2132 is lower than the height of the main platform body 2131. An installation space for fasteners is formed between the side platforms 2132 and the main platform body 2131, which facilitates the assembly and disassembly of the mating platform 213. The side platform 2132 is provided with a third connecting hole 2132a, and the support body 2111 is provided with a fourth connecting hole (not shown). The fastener can be a bolt and a nut. When the mating platform 213 is connected to the support body 2111, the bolt thread passes through the third connecting hole 2132a and the fourth connecting hole and is threaded to the nut. The bolt nut and the nut are located on both sides of the side platform 2132 and the support body 2111.

[0062] In one possible implementation, the clamping assembly 212 includes a finger cylinder 2121 and two grippers 2122. The finger cylinder 2121 includes a cylinder body 21211 and two sliders 21212 disposed on the cylinder body 21211. The cylinder body 21211 is connected to the support 211. The two grippers 2122 are respectively connected to the corresponding sliders 21212. The finger cylinder 2121 can drive the two sliders 21212 to move the two grippers 2122 closer together or further apart to perform clamping or releasing actions. The cylinder body 21211 has a groove 21211a on the side opposite to the mating platform 213, and the two sliders 21212 are slidably disposed in the groove 21211a. The slider 21212 includes a slider body 21212a and an extension body 21212b. The slider body 21212a is slidably disposed in the slide groove 21211a, and the extension body 21212b extends out of the slide groove 21211a and is connected to the corresponding gripper 2122.

[0063] The two grippers 2122 have clamping notches 21222a on their opposite sides. When the two sliders 21212 are close together, the clamping notches 21222a on the two grippers 2122 connect to form a bayonet. The bayonet is used to clamp the outer wall of the expander 42.

[0064] The gripper 2122 includes a first extension 21221 and a second extension 21222. The first extension 21221 is connected to the slider 21212, and the second extension 21222 is perpendicularly connected to the first extension 21221. A clamping notch 21222a is provided on the side of the second extension away from the first extension 21221. A fifth connecting hole 21212b1 is provided on the extension body 21212b, and a sixth connecting hole 21221a is provided on the first extension 21221. The first extension 21221 and the extension body 21212b can be connected by fasteners (not shown). The fasteners can be bolts and nuts. The bolt shank passes through the fifth connecting hole 21212b1 and the sixth connecting hole 21221a and is threadedly connected to the nut. The bolt nut and the nut are located on opposite sides of the extension body 21212b and the first extension 21221. The fasteners are detachable for easy assembly and disassembly. When the two sliders 21212 are far apart, the distance between the two clamping notches 21222a is large, facilitating the placement of the expander 42 between the two clamping notches 21222a. When the two sliders 21212 are close together, the outer wall of the expander 42 fits against the inner wall of the notch. This allows the jaws to easily clamp the expander 42.

[0065] The support 211 has a baffle 21111 along its edge, forming a concave cavity. A clearance notch 21111a communicating with the concave cavity is provided on the baffle 21111. A portion of the cylinder body 21211 is embedded in the concave cavity, and the air pipe connecting the finger cylinder 2121 extends through the clearance notch 21111a. The baffle 21111 is located on the side of the support 211 body opposite to the sliding block 2112.

[0066] In one possible implementation, the drive assembly 13 includes a motor 131 and a lead screw 132, the lead screw 132 being rotatably mounted on the base 11. The sliding body 12 has a threaded groove, and the lead screw 132 is threadedly connected to the threaded groove of the sliding body 12. The motor 131 and the lead screw 132 are drively connected. The drive assembly 13 may further include a reducer 133 and a coupling 134, the input end of the reducer 133 being connected to the motor 131, and the output end of the reducer 133 being connected to the coupling 134, the coupling 134 being connected to the lead screw. The motor 131 operates, sequentially driving the reducer 133, the coupling 134, and the lead screw 132 to move. This causes the sliding body 12 connected to the lead screw 132 to move along the length of the lead screw 132. The movement of the sliding body 12 causes the catheter sheath clamp 21, which holds the dilator 42, to move, allowing the dilator 42 to slowly retract along the catheter sheath 4. The tension generated during this process is transmitted to the force sensor 22. When the force sensor 22 displays a tension value within a certain range, it indicates that the catheter sheath 4 has good smoothness and the product is qualified.

[0067] The catheter sheath activation device further includes a sheath fixing assembly 3, which comprises a sheath mounting plate 31, a connecting seat cylinder 32, and a connecting seat clamp 33. The connecting seat cylinder 32 is vertically connected to the sheath mounting plate 31, and the connecting seat clamp 33 is connected to the side of the connecting seat cylinder 32 opposite to the sheath mounting plate 31. The connecting seat clamp 33 is used to clamp and fix the catheter sheath 4.

[0068] The specific steps for activation testing of the catheter sheath activation device in this application are as follows:

[0069] Step 1: The connecting seat cylinder 32 drives the connecting seat clamp 33 to clamp the catheter sheath 4, and the connecting seat clamp 33 is used to lock and fix the catheter sheath 4.

[0070] Step 2: The motor 131 drives the test mechanism 2 to move forward to the position of the expander 42 connector. After it is in position, the finger cylinder 2121 drives the gripper 2122 to clamp the position of the expander 42 connector. At this time, the system will send a zeroing signal (reset to zero) to the force sensor 22.

[0071] Step 3: The motor 131 drives the test mechanism 2 to slowly retract, and the dilator 42 will slowly retract into the sheath body 41. During this process, a pulling force will be transmitted to the force sensor 22 through the force transmission shaft 25 to measure the data. When the force sensor 22 shows that the pulling force value is within a certain range, it means that the catheter sheath 4 has good smoothness and the product is qualified.

[0072] Step 4: The test is complete once the expander 42 is withdrawn into the sheath body 41.

[0073] Step 5: Motor 131 drives the test mechanism 2 to move forward, returning the expander 42 connector to its original position. Finger cylinder 2121 resets the expander 42 gripper 2122. Motor 131 drives the test mechanism 2 to return to its original position. Connector cylinder 32 resets the connector clamp 33. The test is completed. The tested catheter sheath 4 is removed, and the next product cycle test is performed.

[0074] The preferred embodiments disclosed above are merely illustrative of this application. These preferred embodiments do not exhaustively describe all details, nor do they limit the application to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of this application, thereby enabling those skilled in the art to better understand and utilize this application. This application is limited only by the claims and their full scope and equivalents.

Claims

1. A catheter sheath activation device, characterized in that, include: A translation mechanism, comprising a base, a slider, and a drive assembly, wherein the slider is slidably connected to the base, the drive assembly is disposed on the base, and the drive assembly and the slider are pulsatorically connected to drive the slider to translate along the base; The testing mechanism is disposed on the sliding body. The testing mechanism has a catheter sheath clamp and a force sensor. The force sensor is connected to the catheter sheath clamp and is used to measure the external force on the catheter sheath clamp.

2. The catheter sheath activation device according to claim 1, characterized in that, The testing mechanism includes a mounting base and a slide rail disposed on the mounting base; The mounting base is connected to the sliding body; The catheter sheath clamp is slidably connected to the slide rail; The force sensor is fixed to the mounting base, and the force sensor and the catheter sheath clamp are connected by a force transmission shaft.

3. The catheter sheath activation device according to claim 2, characterized in that, The mounting base is provided with a mounting plate; The mounting plate is located at one end of the slide rail along its length. The force sensor is mounted on the mounting plate; The force transmission shaft is located between the mounting plate and the catheter sheath clamp, and both ends of the force transmission shaft are connected to the mounting plate and the catheter sheath clamp, respectively.

4. The catheter sheath activation device according to claim 3, characterized in that, The mounting plate includes a main body and side platforms disposed on both sides of the main body; The side platform is detachably connected to the mounting base by fasteners; The mainboard body is perpendicular to the mounting base; The force sensor is connected to the motherboard.

5. The catheter sheath activation device according to claim 2, characterized in that, The catheter sheath clamp includes a support and a clamping assembly; The support is slidably connected to the slide rail; The clamping assembly is disposed on the support, and the support is provided with a mating platform on the side near the force sensor; Both the mating platform and the force sensor have threaded grooves; Both ends of the force transmission shaft are provided with external threads, and the two ends of the force transmission shaft are respectively threaded to the threaded grooves on the mating platform and the force sensor.

6. The catheter sheath activation device according to claim 5, characterized in that, The clamping assembly includes a finger cylinder and two grippers; The finger cylinder includes a cylinder body and two sliders disposed on the cylinder body; The cylinder body is connected to the support, and the two grippers are respectively connected to the corresponding sliders; The finger cylinder can drive two sliders to move the two grippers closer together or further apart to perform gripping or releasing actions.

7. The catheter sheath activation device according to claim 6, characterized in that, A clamping notch is provided on one side of the two jaws facing each other; When the two sliders are close together, the clamping notches on the two grippers connect to form a bayonet.

8. The catheter sheath activation device according to claim 7, characterized in that, The gripper includes a first extension and a second extension; The first extension is connected to the slider; The second extension is vertically connected to the first extension, and the clamping notch is provided on the side of the second extension away from the first extension.

9. The catheter sheath activation device according to claim 6, characterized in that, A retaining platform is provided along the edge of the support; The baffles enclose a concave cavity, and the baffles are provided with a clearance opening that communicates with the concave cavity; The cylinder body is partially embedded in the recessed cavity, and the air pipe connecting the finger cylinder extends through the clearance notch.

10. The catheter sheath activation device according to any one of claims 1-9, characterized in that, The drive assembly includes a motor and a lead screw; The lead screw is rotatably mounted on the base; The sliding body has a threaded groove, and the lead screw is threadedly connected to the threaded groove of the sliding body; The motor and the lead screw are connected.

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