Suction device and suction system

Abstract

The application relates to an aspirating device and an aspirating system. The aspirating device comprises a catheter, an inner layer and an outer layer, the inner layer surrounds independent aspirating cavities and guide wire cavities, the outer layer is sleeved outside the inner layer, the surface energy of the outer layer is higher than that of the inner layer, the outer layer is provided with aspirating ports and mounting notches which are all connected with the aspirating cavities, one end of the mounting notch is arranged in the axial direction of the catheter and is spaced from the aspirating port, and the other end extends to the end of the catheter, and a sealing plug comprises a first plug body and a second plug body which are connected with each other and block one end of the aspirating cavity, the surface energy of the second plug body is higher than that of the inner layer, the second plug body fills the mounting notch and covers the first plug body. Thus, the suction force of the aspirating device can be improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a suction device and suction system. Background Technology

[0002] A thrombus is an abnormal blood clot that forms at the site of damage or repair to the inner wall of a blood vessel in the cardiovascular system. It consists of insoluble fibrin, deposited platelets, accumulated white blood cells, and trapped red blood cells. When a thrombus forms and blocks a blood vessel, it interrupts blood flow and can lead to serious clinical consequences: for example, coronary artery blockage can cause myocardial infarction, cerebral artery blockage can cause cerebral infarction, pulmonary artery blockage can cause pulmonary embolism, and arterial and venous blockage in the limbs can cause limb infarction. These conditions can all be life-threatening and require timely intervention.

[0003] Traditional treatments for thrombosis include open thrombectomy, endarterectomy, and intravenous thrombolysis, but these methods have significant limitations: open surgery is highly invasive, and intravenous thrombolysis carries the risk of systemic bleeding and is inefficient. With the development of endovascular interventional techniques, minimally invasive treatments such as catheter-directed thrombolysis, catheter-directed thrombectomy, thrombectomy aspiration, and mechanical thrombectomy have gradually become the mainstream.

[0004] Thrombus aspiration is widely used in clinical practice due to its advantages such as simple operation, rapid removal, and low cost. Thrombus aspiration uses a suction device to directly remove the thrombus. However, traditional suction devices often suffer from poor airtightness between the device and its mounting base after assembly, which weakens the suction force and ultimately affects the device's effectiveness in removing the thrombus. Summary of the Invention

[0005] One technical problem addressed by this application is how to improve the suction force of a suction device.

[0006] A suction device, comprising:

[0007] A catheter includes an inner layer and an outer layer. The inner layer forms an independent aspiration cavity and a guidewire cavity. The outer layer is fitted over the inner layer, and the surface energy of the outer layer is higher than that of the inner layer. The outer layer has aspiration ports and an installation notch, both communicating with the aspiration cavities. One end of the installation notch is spaced apart from the aspiration ports along the axial direction of the catheter, and the other end extends to the end of the catheter.

[0008] The sealing plug includes a first plug body and a second plug body that are connected to each other and block one end of the suction cavity. The surface energy of the second plug body is higher than that of the inner layer. The second plug body fills the mounting gap and covers the first plug body.

[0009] In one embodiment, the first plug has a first contact surface facing the second plug, and the second plug has a second contact surface facing the first plug. The second contact surface is attached to the first contact surface. A groove is formed on the first contact surface. The second plug includes a protrusion provided on the second contact surface, and the protrusion engages with the groove.

[0010] In one embodiment, the width of the groove decreases, increases, or remains constant along the recess direction of the groove.

[0011] In one embodiment, the second plug further includes a stop block protruding from the end of the second mating surface, the ridge strip is connected to the stop block, and the maximum protrusion height of the stop block relative to the second mating surface is greater than the maximum protrusion height of the ridge strip relative to the second mating surface, and the end of the first plug abuts against the stop block.

[0012] In one embodiment, the outer surface of the second plug is smoothly connected to the outer surface of the outer layer.

[0013] In one embodiment, after the installation notch is made, the exposed inner wall surface of the suction cavity has a length of 1 / 3 to 1 / 2 of the circumference of the suction cavity in the circumferential direction.

[0014] In one embodiment, after the first plug body and the inner layer are connected by an ultrasonic heat fusion process, the second plug body and the first plug body are then connected by an ultrasonic heat fusion process.

[0015] In one embodiment, the amplitude of the ultrasonic waves in the ultrasonic heat-melting process is gradually increased from the start of operation.

[0016] In one embodiment, the initial amplitude of the ultrasonic wave is 4.8 μm to 5.2 μm, the amplitude of the ultrasonic wave increases from the initial value to 5 μm to 25 μm at a rate of 0.1 μm / s to 0.5 μm / s, the frequency of the ultrasonic wave is 12 kHz to 20 kHz, the pre-tightening pressure of the ultrasonic heat-melting process is 100 N to 140 N, the heat-melting time of the ultrasonic heat-melting process is 1 second to 8 seconds, and the holding pressure time after heat-melting is 45 seconds to 105 seconds.

[0017] In one embodiment, the inner layer is made of the same material as the surface of the first plug, and the inner layer includes one or more of polytetrafluoroethylene (PTFE), sodium naphthalene-treated PTFE, and PTFE-coated polymer materials. The outer layer is made of the same material as the surface of the second plug, and the outer layer includes one or more of block polyamide, polyvinyl chloride (PVC), nylon, thermoplastic polyurethane, and ethylene-vinyl acetate copolymer materials.

[0018] In one embodiment, the catheter further includes a reinforcing layer made of a different material than the inner and outer layers, the reinforcing layer being located between the inner and outer layers and surrounding the suction cavity, and the reinforcing layer extending from one end of the suction cavity away from the mounting notch to the mounting notch.

[0019] In one embodiment, the device further includes two convex rings spaced apart along the axial direction of the conduit and sleeved on the outer layer, with the suction port located between the two convex rings, and one of the convex rings located between the suction port and the mounting notch.

[0020] A suction system includes a mounting base and a suction device as described above. The mounting base has a first channel and a second channel that are arranged in a cross configuration and communicate with each other. A conduit is inserted in the first channel so that a sealing plug is located within the first channel. The second channel communicates with the suction port. The mounting base has two input holes that communicate with the first channel. Along the axial direction of the conduit, the suction port is located between the two input holes. In one embodiment, one of the input holes communicates with a position in the first channel that mates with the sealing plug.

[0021] One technical effect of one embodiment of this application is that, given that the outer layer of the conduit and the second plug of the sealing plug are both made of materials with higher surface energy than the inner layer, when the outer layer and the sealing plug are connected to the mounting base by adhesive, the outer layer and the second plug with higher surface energy will be fully wetted by the adhesive, thereby enabling the entire suction device and the mounting base to effectively form a strong intermolecular force through the adhesive, ensuring that the adhesive seals the positions on both sides of the suction port well, thereby improving the airtightness of the suction chamber and the suction force of the entire suction device. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the planar structure of a suction system provided in one embodiment.

[0023] Figure 2 for Figure 1 The diagram shows a planar cross-sectional view of the suction system.

[0024] Figure 3 for Figure 1 A partial planar cross-sectional view of the catheter in the suction system is shown.

[0025] Figure 4 for Figure 1 The diagram shows a planar structure of the catheter in the suction system.

[0026] Figure 5 for Figure 1 A three-dimensional schematic diagram of the catheter in the suction system shown.

[0027] Figure 6 for Figure 1 A three-dimensional structural schematic diagram of the suction device provided in the first example of the suction system shown.

[0028] Figure 7 for Figure 6 A three-dimensional structural diagram of the sealing plug in the suction device shown.

[0029] Figure 8 for Figure 7 A three-dimensional structural diagram of the first plug body in the sealing plug shown.

[0030] Figure 9 for Figure 7 A three-dimensional structural diagram of the second plug body in the sealing plug shown.

[0031] Figure 10 for Figure 1 A three-dimensional structural schematic diagram of the suction device provided in the second example of the suction system shown.

[0032] Figure 11 for Figure 10 A three-dimensional structural diagram of the sealing plug in the suction device shown.

[0033] Figure 12 for Figure 1 A three-dimensional structural diagram of the second plug provided in the third example of the suction system shown.

[0034] Figure 13 for Figure 1 The diagram shows a three-dimensional structure of the suction system with a convex ring on the catheter.

[0035] Reference numerals: suction system 10, suction device 20, bonding area 21, mounting base 30, first channel 31, second channel 32, input hole 33, guide wire 40, guide tube 100, inner layer 110, suction cavity 111, guide wire cavity 112, outer layer 120, suction port 121, mounting notch 122, bottom surface 1221, reinforcing layer 130, sealing plug 200, first plug body 210, first mating surface 211, groove 212, second plug body 220, second mating surface 221, protrusion 222, stop block 223, protruding ring 300. Detailed Implementation

[0036] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0037] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application 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, and therefore should not be construed as a limitation of this application.

[0038] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0039] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; 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; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0040] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0041] In the field of interventional medical devices, the end of a medical device that is at least partially inserted into the human or animal body is generally referred to as the "proximal end" (closer to the operator) and the end farther from the operator as 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 of the medical device during delivery, while "radial direction" generally refers to the direction perpendicular to the "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0042] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0043] See Figure 1 and Figure 2 An embodiment of this application provides a suction system 10 including a suction device 20 and a mounting base 30. The mounting base 30 has a first channel 31 and a second channel 32 that are interconnected. The first channel 31 and the second channel 32 are arranged at an angle, thus forming a roughly Y-shaped structure. The mounting base 30 has two input holes 33 that are interconnected with the first channel 31 and are used to inject glue into the first channel 31. Along the extension direction of the first channel 31, with the connection point between the first channel 31 and the second channel 32 as a reference position, the two input holes 33 are located on opposite sides of the reference position, that is, the reference position is located between the two input holes 33. Of course, the mounting base 30 may also have vent holes that are interconnected with and correspond one-to-one with the input holes 33, so that gas can be discharged from the vent holes during the injection of glue from the input holes 33.

[0044] See Figure 2 , Figure 3 , Figure 4 , Figure 5 and Figure 6 The suction device 20 includes a conduit 100 and a sealing plug 200. The conduit 100 includes an inner layer 110 and an outer layer 120. The inner layer 110 forms a suction cavity 111 and a guidewire cavity 112. The suction cavity 111 and the guidewire cavity 112 are independent of each other and do not communicate with each other. The outer layer 120 is sleeved outside the inner layer 110 and is located on the outermost side of the conduit 100. The surface energy of the outer layer 120 is higher than that of the inner layer 110. For example, the surface energy of the inner layer 110 is extremely low. The surface energy of the inner layer 110 can be from 16.4 mJ / m² to 25 mJ / m², such as 16.4 mJ / m², 20 mJ / m², or 25 mJ / m². The surface energy of the outer layer 120 can be from 29 mJ / m² to 50 mJ / m², for example, the surface energy of the outer layer 120 can be 29 mJ / m², 40 mJ / m² or 50 mJ / m², etc. The outer layer 120 is provided with a suction port 121 and a mounting notch 122. When the conduit 100 exists alone, both the suction port 121 and the mounting notch 122 are in communication with the suction chamber 111 and the outside. One end of the mounting notch 122 is spaced apart from the suction port 121 along the axial direction of the conduit 100, and the other end of the mounting notch 122 extends to the end of the conduit 100 near the suction port 121. The sealing plug 200 includes a first plug body 210 and a second plug body 220 connected to each other. The first plug body 210 blocks one end of the suction cavity 111. The surface energy of the second plug body 220 is also higher than that of the inner layer 110. For example, the second plug body 220 and the outer layer 120 can be made of the same or different materials. The first plug body 210 and the inner layer 110 can be made of the same or different materials. The second plug body 220 fills the installation notch 122 and covers the first plug body 210.

[0045] During the assembly of the suction device 20 and the mounting base 30, the conduit 100 is first inserted into the first channel 31, so that the sealing plug 200 is located within the first channel 31, and the suction port 121 is located at the position where the first channel 31 and the second channel 32 communicate with each other. This allows the suction chamber 111 to communicate with the second channel 32 through the suction port 121. Since the connection between the first channel 31 and the second channel 32 is located between the two input holes 33, the suction port 121 is also located between the two input holes 33. One of the input holes 33 communicates with the position in the first channel 31 that mates with the sealing plug 200; this can be understood as the input hole 33 corresponding to the sealing plug 200. In subsequent operations, the guide wire 40 can be inserted through the first channel 31 and the guide wire cavity 112 and extend outside the body. It can be understood that during the process of the suction device 20 entering the body, the guide wire 40 can guide the movement of the suction device 20, ensuring that the suction device 20 smoothly enters the designated position within the body. The thrombus extracted from the body through the suction chamber 111 can be discharged out of the body through the second channel 32. Then, glue is injected into the two inlet ports 33, forming two adhesive areas 21 on the catheter 100. These two adhesive areas 21 are located on opposite sides of the suction port 121, with one adhesive area 21 corresponding to the location of the sealing plug 200. After the glue cures and forms a bond, the bond securely connects the entire suction device 20 to the mounting base 30. The bond also effectively seals the first channel 31 on both sides of the suction port 121, preventing the suction chamber 111 from communicating with the outside through the suction port 121 and the first channel 31, thus affecting the vacuum level of the suction chamber 111. This increases the suction force of the suction device 20, ultimately improving its effectiveness in removing thrombi.

[0046] If the suction device 20 is made of the same single material as the inner layer 110, the surface energy of the suction device 20 will be relatively low. When glue is injected into the inlet 33, the glue needs to flow into the tail end (i.e., proximal end) of the conduit 100 and enter the suction chamber 111 to seal the tail end of the suction chamber 111. However, due to the low surface energy of the inner layer 110, it has extremely strong anti-adhesion properties, making it difficult for the glue to effectively wet the inner surface of the suction chamber 111. As a result, it is difficult for the inner surface of the suction chamber 111 to form a strong intermolecular force with the glue after curing. Even if the connection between the tail end of the conduit 100 and the mounting base 30 can meet the relevant requirements for breaking force, the glue will not be able to seal the tail end of the suction chamber 111 well. This will cause the suction chamber 111 to communicate with the outside through the first channel 31, thus failing to guarantee the airtightness and vacuum requirements of the suction chamber 111, ultimately affecting the suction force and suction effect of the suction device 20.

[0047] Regarding the suction device 20 in the above embodiments, since the outer layer 120 of the conduit 100 and the second plug 220 of the sealing plug 200 are both made of materials with a surface energy higher than that of the inner layer 110, when glue is injected into the input hole 33, the outer layer 120 and the second plug 220 with higher surface energy will be fully wetted by the glue, thereby enabling the suction device 20 and the mounting base 30 to effectively form a strong intermolecular force through the adhesive, ensuring that the adhesive seals the first channel 31 well at the positions on both sides of the suction port 121, thereby improving the airtightness of the suction chamber 111 and the suction force of the entire suction device 20.

[0048] In some embodiments, the inner layer 110 comprises polytetrafluoroethylene (PTFE), specifically medical-grade modified PTFE, which makes the surface of the inner layer 110 smooth, facilitating the passage of fluids and blood clots. 2% polyether block copolymer may be added to the inner layer 110 as a compatibilizer, thereby improving the compatibility between the inner layer 110 and the outer layer 120. Alternatively, the inner layer 110 may also use sodium naphthalene-treated PTFE or have PTFE coated on the surface of a polymer material. The outer layer 120 comprises block polyamide (Pebax) material, thus providing a sufficiently high surface energy. Alternatively, the outer layer 120 may also comprise polyvinyl chloride (PVC), nylon (PA), thermoplastic polyurethane (TPU), or ethylene-vinyl acetate copolymer (EVA), as long as the surface energy of the outer layer 120 meets the requirements. The suction port 121 can be oval, rectangular, triangular, or other polygonal shapes, or it can be circular or elliptical. The length of the suction port 121 can be 5mm to 6mm, and the width of the suction port 121 can be less than the diameter of the conduit 100. The length of the installation notch 122 can be 5mm to 6mm.

[0049] See Figure 3 and Figure 5In some embodiments, the conduit 100 further includes a reinforcing layer 130. The reinforcing layer 130 is made of a different material than the inner layer 110 and the outer layer 120. The reinforcing layer 130 is located between the inner layer 110 and the outer layer 120, and surrounds the suction cavity 111. The reinforcing layer 130 extends from the end of the suction cavity 111 away from the mounting notch 122 to the mounting notch 122. That is, after the conduit 100 is processed, the reinforcing layer 130 can be omitted from a small section of the conduit 100 corresponding to the section where the mounting notch 122 needs to be subsequently opened, while the reinforcing layer 130 is provided at other locations of the conduit 100. In short, the length of the reinforcing layer 130 is less than the length of the outer layer 120, such that the length of the reinforcing layer 130 is approximately equal to the difference in length between the inner layer 110 and the mounting notch 122. The reinforcing layer 130 can be made of stainless steel braided mesh, or at least one of nickel-titanium alloy braided mesh tubing, polymer braided mesh tubing, stainless steel spring tubing, nickel-titanium alloy spring tubing, and polymer spring tubing. By setting the reinforcing layer 130, the structural strength and anti-collapse and anti-bending performance of the entire catheter 100 can be improved, thereby improving the flexibility and pushability of the catheter 100.

[0050] In some embodiments, the overall length of the catheter 100 can be 40cm to 150cm, the outer diameter of the catheter 100 is 2mm to 8mm, the inner diameter of the guidewire lumen 112 is 0.5mm to 1.5mm, and the inner diameter of the aspiration lumen 111 is 1.5mm to 7mm. The length of the sealing plug 200 can be 20mm to 60mm.

[0051] See Figure 5 , Figure 6 and Figure 7 In some embodiments, after the first plug 210 cooperates with the suction cavity 111 to seal the suction cavity 111, the first plug 210 can be connected to the inner layer 110 via an ultrasonic heat fusion process. Since the first plug 210 and the inner layer 110 are made of the same material, this can improve the connection strength between the first plug 210 and the inner layer 110, and also enhance the sealing performance of the first plug 210 at the end of the suction cavity 111. After the first plug 210 is connected to the inner layer 110, the second plug 220 is then connected to the first plug 210 via the same ultrasonic heat fusion process.

[0052] It is understood that during the connection process between the first plug 210 and the inner layer 110 via ultrasonic heat fusion, the first pressure plate can be positioned below the conduit 100, providing support to the conduit 100 and emitting ultrasonic waves. The second pressure plate can be positioned above the first plug 210, exerting downward pressure on the first plug 210, thereby pressing the conduit 100 and the first plug 210 between the first and second pressure plates. During the connection process between the first plug 210 and the second plug 220 via ultrasonic heat fusion, the first pressure plate remains below the conduit 100, providing support, while the second pressure plate is positioned above the second plug 220, exerting downward pressure on it. This ensures that the first plug 210 and the second plug 220 are tightly fitted together and form a good connection.

[0053] See Figure 6 , Figure 7 , Figure 8 and Figure 9 In some embodiments, the first plug 210 has a first mating surface 211, which faces the second plug 220. The second plug 220 has a second mating surface 221, which faces the first plug 210. The second mating surface 221 and the first mating surface 211 are mated together to form a connection, so that the second plug 220 can completely cover the first plug 210. A groove 212 is formed on the first mating surface 211, and the second plug 220 includes a protrusion 222, which protrudes from the second mating surface 221. The protrusion 222 cooperates with the groove 212, so that the number of protrusions 222 and grooves 212 are equal and correspond one-to-one. This can guide and position the assembly of the second plug 220, thereby improving the assembly efficiency and accuracy between the first plug 210 and the second plug 220, and reducing the possibility of them slipping against each other during the ultrasonic hot-melt process. On the other hand, it can also create an interlocking relationship between the first plug 210 and the second plug 220, thereby improving the connection strength between the first plug 210 and the second plug 220. When the groove 212 is provided on the first mating surface 211, during the process of connecting the first plug 210 and the inner layer 110 through ultrasonic heat fusion, the second pressure plate will smoothly contact the first mating surface 211 to apply stable pressure to the first plug 210, thereby improving the connection strength between the first plug 210 and the inner layer 110. In other embodiments, a protrusion 222 can be provided on the first mating surface 211, and the groove 212 can be formed on the second mating surface 221.

[0054] In some embodiments, see Figure 7For example, along the concave direction of groove 212, the width of groove 212 increases. In this case, groove 212 can be a dovetail groove, and the number of dovetail grooves can be one or more. (See also...) Figure 10 and Figure 11 For example, along the concave direction of groove 212, the width of groove 212 decreases, and groove 212 can be a serrated groove, etc., and the number of serrated grooves can be multiple. Alternatively, along the concave direction of groove 212, the width of groove 212 remains constant, and groove 212 can be a rectangular groove.

[0055] See Figure 6 and Figure 10 In some embodiments, the outer surface of the second plug 220 smoothly transitions to the outer surface of the outer layer 120. This can be understood as the outer surface of the second plug 220 being flush with the outer surface of the outer layer 120, so that the outer surface of the second plug 220 and the outer surface of the outer layer 120 are located on the same cylindrical surface. For example, the shape of the first plug 210 is approximately adapted to the shape of the suction cavity 111. When the first plug 210 mates with the suction cavity 111, the first mating surface 211 can be flush with the bottom surface 1221 extending axially along the conduit 100 on the mounting notch 122. When the second plug 220 is connected to the first plug 210, the second plug 220 can abut against the bottom surface 1221 of the mounting notch 122, thereby covering the bottom surface 1221. After the second plug 220 has just filled the mounting notch 122, the outer surface of the second plug 220 can smoothly transition to the outer surface of the outer layer 120. This improves the flowability of the adhesive after it is injected into the inlet 33, preventing air bubbles and thus enhancing the sealing performance of the bonded joint. In other embodiments, the second plug 220 may not cover the bottom surface 1221 of the mounting notch 122.

[0056] See Figure 12In some embodiments, the second plug 220 further includes a stop 223, which may protrude from the end of the second mating surface 221. The stop 223 may cooperate with the suction cavity 111, and the protrusion 222 may be connected to the stop 223. For example, the stop 223 may be provided on both ends of the second mating surface 221, i.e., there are two stop 223s. Alternatively, the stop 223 may be provided on one end of the second mating surface 221, i.e., there is one stop 223. The maximum protrusion height of the stop 223 relative to the second mating surface 221 is greater than the maximum protrusion height of the protrusion 222 relative to the second mating surface 221, and the end of the first plug 210 abuts against the stop 223. By setting the stop 223, the positioning accuracy of the second plug 220 can be reasonably improved during the assembly process, and the possibility of the first plug 210 and the second plug 220 sliding against each other during the ultrasonic hot melt process can be reduced. After the assembly is completed, the stop 223 can also further improve the sealing effect and suction effect.

[0057] See Figure 5 and Figure 6 In some embodiments, after the installation notch 122 is opened, the exposed inner wall surface of the suction cavity 111 has a circumferential length of 1 / 3 to 1 / 2 of the total circumference of the suction cavity 111. This can improve the connection strength between the first plug 210 and the inner layer 110. Specifically, during the connection process between the first plug 210 and the inner layer 110 via ultrasonic heat fusion, given the reasonable circumferential length of the exposed inner wall surface of the suction cavity 111, less pressure can be used to ensure that the first plug 210 and the inner wall surface of the suction cavity 111 are fully fitted, thereby improving the connection strength between the first plug 210 and the inner layer 110. On the other hand, during the process of connecting the second plug 220 and the first plug 210 through ultrasonic heat fusion, the distance between the first mating surface 211 and the second mating surface 221 and the first pressure plate emitting ultrasonic waves below is relatively small. This makes it easier for the ultrasonic waves emitted by the first pressure plate to reach the first mating surface 211 and the second mating surface 221, thereby improving the connection efficiency and strength between the first mating surface 211 and the second mating surface 221.

[0058] If the entire sealing plug 200 is integrally molded to seal the suction cavity 111, that is, the first plug body 210 and the second plug body 220 are integrally connected to form an integral sealing plug 200, and then the integral sealing plug 200 is connected to the inner layer 110 to seal the suction cavity 111. Therefore, during the connection process between the integral sealing plug 200 and the inner layer 110 through ultrasonic heat fusion, the distance between the first pressure plate and the second pressure plate is relatively large, and the first pressure plate and the second pressure plate form line contact with the conduit 100 and the sealing plug 200, respectively. This results in uneven force between the sealing plug 200 and the inner layer 110, leading to defects in the local area of ​​poor welding effect between the sealing plug 200 and the inner layer 110, ultimately affecting the connection strength between the sealing plug 200 and the inner layer 110 and the sealing effect of the sealing plug 200 on the suction cavity 111. On the other hand, in order to make the sealing plug 200 fully contact the inner layer 110, the first pressure plate and the second pressure plate need to generate greater pressure. However, the inner layer 110 has poor creep resistance and is difficult to recover its initial shape after being compressed, which will also affect the connection strength between the sealing plug 200 and the inner layer 110, as well as the sealing effect of the sealing plug 200 on the suction cavity 111.

[0059] Regarding the suction device 20 in the above embodiments, since the first plug 210 and the second plug 220 are formed separately, the second plug 220 is connected to the first plug 210 after the first plug 210 is connected to the inner layer 110. This results in a smaller distance between the first pressure plate and the second pressure plate during the connection process between the first plug 210 and the inner layer 110, allowing for sufficient contact between the contact surfaces of the first plug 210 and the inner layer 110 without excessive pressure. This prevents excessive creep between the first plug 210 and the inner layer 110 due to excessive pressure, thereby improving the connection strength between the first plug 210 and the inner layer 110. During the connection process between the second plug 220 and the first plug 210, a good surface contact is formed between the first contact surface 211 and the second contact surface 221, so that the force between the first contact surface 211 and the second contact surface 221 is uniform. The first contact surface 211 and the second contact surface 221 can be fully attached without excessive pressure, thereby improving the connection effect between the first contact surface 211 and the second contact surface 221.

[0060] In some embodiments, during the operation of the ultrasonic heat fusion process, the amplitude of the ultrasonic waves is gradually increased from the start of operation, i.e., from the emission of ultrasonic waves from the first pressure plate. This improves the uniformity of the weld and avoids uneven welding caused by stress concentration due to a single large amplitude.

[0061] In some embodiments, the initial amplitude of the ultrasonic wave is 4.8 μm to 5.2 μm, and the amplitude increases from the initial value to 5 μm to 25 μm at a rate of 0.1 μm / s to 0.5 μm / s. The frequency of the ultrasonic wave is 12 kHz to 20 kHz. The pre-tightening pressure of the ultrasonic heat-melting process is 100 N to 140 N, the heat-melting time is 1 second to 8 seconds, and the pressure holding time after heat-melting is 45 seconds to 105 seconds. It is understood that if the pre-tightening pressure of the first and second pressure plate supports is too high, the sealing plug 200 or the conduit 100 will deform or shift. If the pre-tightening pressure is too low, the welding time will be too long, also affecting the sealing effect of the sealing plug 200 on the suction cavity 111. If the heat-melting time is too long, it will cause excessive decomposition of the material of the sealing plug 200 or the conduit 100. After the ultrasonic waves stop being emitted, the first and second pressure plates continue to apply pressure to create a pressure-holding effect, and the pressure-holding time is maintained for a certain length to ensure the connection strength.

[0062] See Figure 1 , Figure 2 and Figure 13 In some embodiments, the suction device 20 further includes two protruding rings 300, which are spaced apart along the axial direction of the conduit 100. The two protruding rings 300 are fitted onto the outer layer 120, such that the protruding rings 300 protrude a certain height relative to the outer layer 120 along the radial direction of the conduit 100. The suction port 121 is located between the two protruding rings 300, with one protruding ring 300 located between the suction port 121 and the mounting notch 122. When the suction device is assembled with the mounting base 30, the two protruding rings 300 can be located between the two input holes 33, that is, between the two bonding areas 21. Therefore, during the injection of adhesive into the input holes 33, the protruding rings 300 can effectively prevent adhesive from flowing into the suction port 121, effectively avoiding the adhesive from blocking the suction port 121.

[0063] During the manufacturing process of the suction system 10, a suction port 121 and an installation notch 122 can be first opened on the conduit 100. Then, the first plug 210 is connected to the inner layer 110 by an ultrasonic heat fusion process, and the second plug 220 is connected to the first plug 210 by an ultrasonic heat fusion process, thus sealing the suction cavity 111 with the sealing plug 200. Next, the processed suction device 20 is inserted into the first channel 31 of the mounting base 30, and a support mandrel passes through the first channel 31 and the guide wire cavity 112. The diameter of the support mandrel can be no less than the diameter of the guide wire cavity 112. During the injection of adhesive, the support mandrel can effectively prevent adhesive from entering the guide wire cavity 112. After the adhesive cures to form a bond, the suction device 20 will be connected to the mounting base 30, and the bond will effectively seal the positions of the first channel 31 on both sides of the suction port 121, thereby improving the airtightness of the suction cavity 111 and the suction force of the entire suction device 20.

[0064] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0065] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A suction device, characterized in that, include: A catheter includes an inner layer and an outer layer. The inner layer forms an independent aspiration cavity and a guidewire cavity. The outer layer is fitted over the inner layer, and the surface energy of the outer layer is higher than that of the inner layer. The outer layer has aspiration ports and an installation notch, both communicating with the aspiration cavities. One end of the installation notch is spaced apart from the aspiration ports along the axial direction of the catheter, and the other end extends to the end of the catheter. The sealing plug includes a first plug body and a second plug body that are connected to each other and block one end of the suction cavity. The surface energy of the second plug body is higher than the surface energy of the inner layer. The second plug body fills the mounting gap and covers the first plug body.

2. The suction device according to claim 1, characterized in that, The first plug has a first contact surface facing the second plug, and the second plug has a second contact surface facing the first plug. The second contact surface is attached to the first contact surface. A groove is formed on the first contact surface. The second plug includes a protruding strip that is provided on the second contact surface. The protruding strip cooperates with the groove.

3. The suction device according to claim 2, characterized in that, Along the concave direction of the groove, the width of the groove may decrease, increase, or remain constant.

4. The suction device according to claim 2, characterized in that, The second plug also includes a stop block protruding from the end of the second mating surface. The convex strip is connected to the stop block, and the maximum protrusion height of the stop block relative to the second mating surface is greater than the maximum protrusion height of the convex strip relative to the second mating surface. The end of the first plug abuts against the stop block.

5. The suction device according to claim 1, characterized in that, The outer surface of the second plug is smoothly connected to the outer surface of the outer layer.

6. The suction device according to claim 1, characterized in that, When the installation notch is made, the length of the inner wall surface of the suction cavity exposed in the circumferential direction of the suction cavity is 1 / 3 to 1 / 2 of the circumference of the suction cavity.

7. The suction device according to claim 1, characterized in that, After the first plug body and the inner layer are connected by an ultrasonic hot-melt process, the second plug body and the first plug body are then connected by an ultrasonic hot-melt process.

8. The suction device according to claim 7, characterized in that, From the start of operation, the amplitude of the ultrasonic waves in the ultrasonic heat-melting process is gradually increased.

9. The suction device according to claim 8, characterized in that, The initial amplitude of the ultrasonic wave is 4.8 μm to 5.2 μm, and the amplitude of the ultrasonic wave increases from the initial value to 5 μm to 25 μm at a rate of 0.1 μm / s to 0.5 μm / s. The frequency of the ultrasonic wave is 12 kHz to 20 kHz. The pre-tightening pressure of the ultrasonic heat-melting process is 100 N to 140 N. The heat-melting time of the ultrasonic heat-melting process is 1 second to 8 seconds. The pressure holding time after heat-melting is 45 seconds to 105 seconds.

10. The suction device according to claim 1, characterized in that, The inner layer is made of the same material as the surface of the first plug, and the inner layer includes polytetrafluoroethylene (PTFE), sodium naphthalene-treated PTFE, or a polymer material coated with PTFE. The outer layer is made of the same material as the surface of the second plug, and the outer layer includes block polyamide, polyvinyl chloride, nylon, thermoplastic polyurethane, or ethylene-vinyl acetate copolymer.

11. The suction device according to claim 1, characterized in that, The catheter also includes a reinforcing layer made of a different material than the inner and outer layers. The reinforcing layer is located between the inner and outer layers and surrounds the suction cavity. The reinforcing layer extends from the end of the suction cavity away from the mounting notch to the mounting notch.

12. The suction device according to claim 1, characterized in that, It also includes two convex rings spaced apart along the axial direction of the conduit and sleeved on the outer layer, with the suction port located between the two convex rings, and one of the convex rings located between the suction port and the mounting notch.

13. A suction system, characterized in that, The device includes a mounting base and a suction device according to any one of claims 1 to 12. The mounting base has a first channel and a second channel that are arranged in a cross configuration and communicate with each other. The conduit is inserted in the first channel so that the sealing plug is located in the first channel. The second channel communicates with the suction port. The mounting base has two input holes that communicate with the first channel. Along the axial direction of the conduit, the suction port is located between the two input holes. One of the input holes communicates with a position in the first channel that mates with the sealing plug.

Images