Suction part and suction system

Abstract

The invention provides a suction part and a suction system, and relates to the technical field of medical instruments. According to the suction piece, the outer diameter of the suction piece can be kept small, and the suction flow speed and suction force can be improved by fully utilizing a large catheter cavity of a guide catheter. The suction piece comprises a suction pipe, a filling body and a conveying assembly. Wherein the outer wall of the suction pipe is sleeved with the filling body, a filling space is defined by the filling body and the outer wall of the suction pipe, and the filling body can generate elastic deformation; the conveying assembly is connected with the pipe wall of the suction pipe, the part, connected with the pipe wall, of the conveying assembly extends to the position corresponding to the filling body in the axial direction of the suction pipe, the conveying assembly is provided with a conveying channel, and the conveying channel communicates with the filling space.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a suction piece and a suction system. Background Art

[0002] Percutaneous transluminal coronary intervention (PCI) is a minimally invasive procedure that uses catheter technology to clear narrowed or blocked coronary arteries and improve heart blood flow. It is commonly used to treat conditions such as coronary heart disease and acute myocardial infarction. The core steps of PCI include vascular puncture, catheter guidance, balloon dilation, and stent implantation. PCI is characterized by minimal trauma and rapid recovery.

[0003] During PCI surgery, thrombus is usually removed from a blood vessel using an aspiration catheter. In related art, the aspiration catheter is relatively large, especially with a thick outer diameter, making it difficult for the aspiration catheter to enter a smaller blood vessel. Summary of the Invention

[0004] The present application provides a suction piece and a suction system, which can keep the suction piece at a relatively small outer diameter, thereby making full use of the larger lumen of the guide catheter and increasing the suction flow rate and suction force.

[0005] In one aspect, the present application provides a suction device comprising: a suction tube, a filling body, and a delivery assembly. The suction tube has a suction channel; the filling body is sleeved on the outer wall of the suction tube and encloses a filling space with the outer wall of the suction tube, and the filling body is capable of elastic deformation; the delivery assembly is connected to the tube wall of the suction tube, and the portion of the delivery assembly connected to the tube wall extends along the axial direction of the suction tube to a position corresponding to the filling body, and the delivery assembly has a delivery channel that communicates with the filling space.

[0006] The suction piece provided by the present application has a filling body disposed on the outer wall of the suction tube. The filling body can be changed in size by transferring fluid into the filling space enclosed by the filling body and the suction tube. This allows the filling body to fill the gap between the suction tube and the guide catheter. This facilitates generating a relatively high negative pressure within the suction tube when suction is applied to the guide catheter. Simultaneously, a delivery assembly is connected to the tube wall of the suction tube along the axial direction of the suction tube, and the delivery assembly is extended to a position corresponding to the filling space. Fluid can be transferred into the filling space through the delivery channel of the delivery assembly. This structural arrangement utilizes the tube wall of the suction tube to provide an installation location for the delivery assembly, eliminating the need to attach the delivery assembly to the inner or outer wall of the suction tube. This allows the delivery assembly to not completely protrude from the outer wall of the suction tube, eliminating the need to change the overall radial dimensions of the suction piece. This allows the suction piece to maintain a relatively small outer diameter, facilitating full utilization of the larger lumen of the guide catheter and improving suction flow rate and suction force.

[0007] In one possible implementation of the present application, along the axial direction of the suction tube, the conveying assembly includes an extension section and a connecting section, the extension section is used to connect to the pressure source, at least a portion of the connecting section is penetrated into the tube wall along the axial direction of the suction tube, and a connecting gap is provided on the tube wall, and the conveying channel and the filling space are connected through the connecting gap.

[0008] In one possible implementation of the present application, the cross-section of at least a portion of the connecting section is in the shape of a flat ring, the length of the major axis of the flat ring is greater than the length of the minor axis of the flat ring, and the length of the major axis is greater than the thickness of the tube wall, the minor axis is parallel to the radial direction of the suction tube, and the major axis and the minor axis are perpendicular to each other.

[0009] In a possible implementation of the present application, the length of the minor axis is less than or equal to 0.15 mm; and / or the length of the major axis is less than or equal to 0.6 mm.

[0010] In one possible implementation of the present application, the outer diameter of the extension section is greater than the outer diameter of the connecting section;

[0011] And / or, the outer diameter of the extension section is greater than or equal to 0.5 mm, and the outer diameter of the connecting section is less than or equal to 0.4 mm.

[0012] In one possible implementation of the present application, the conveying assembly includes a conveying member and a connecting member, the distal end of the conveying member is sealedly connected to the proximal end of the connecting member, a portion of the conveying member and the connecting member form a connecting section, the hardness of the connecting member is less than the hardness of the conveying member, and the connecting member has a connecting gap.

[0013] In a possible implementation of the present application, the proximal end of the connecting member is sleeved on the distal end of the conveying member and bonded to the distal end of the conveying member.

[0014] In a possible implementation of the present application, the suction tube includes a coating layer, a support layer and a smooth layer. The smooth layer encloses a suction channel, the support layer coats the smooth layer, and the coating layer coats the support layer.

[0015] In a possible implementation of the present application, the strength of the support layer is greater than the strength of at least one of the covering layer and the smooth layer.

[0016] In one possible implementation of the present application, the coating layer includes at least two coating segments, which are sequentially distributed along the axial direction of the suction tube, and the hardness of the at least two coating segments decreases sequentially from the proximal end to the distal end of the suction tube.

[0017] In another aspect, the present application provides an aspiration system comprising: a guide catheter, a filling device, a suction apparatus, and a suction member provided by any of the above. The guide catheter comprises a guide channel having an inner diameter greater than the outer diameter of the suction tube; the filling device is connected to a delivery assembly, and the filling device fills the filling space with fluid via the delivery assembly, enabling the filling fluid to fill the gap between the suction tube and the guide catheter; the suction tube comprises a suction channel, which is connected to the guide channel, and the suction apparatus aspirates the clot at the distal end of the suction tube through the suction channel and the guide channel.

[0018] The suction system provided in the present application includes the suction piece provided by any one of the above items, so the suction piece can maintain a smaller outer diameter, which is conducive to fully utilizing the larger lumen of the guide catheter to increase the suction flow rate and suction force. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A schematic diagram of the structure of the suction system provided in this application;

[0020] Figure 2 A schematic diagram of the structure of the suction piece provided in this application;

[0021] Figure 3 Provided for this application Figure 2 A magnified schematic diagram of part A;

[0022] Figure 4 Provided for this application Figure 3 Schematic diagram of the cross-sectional structure along the BB direction;

[0023] Figure 5 Provided for this application Figure 3 Schematic diagram of the cross-sectional structure along CC direction;

[0024] Figure 6 This is a schematic cross-sectional structural diagram of the conveying member in the suction member provided in this application;

[0025] Figure 7Provided for this application Figure 6 Schematic diagram of the cross-sectional structure along the DD direction;

[0026] Figure 8 A schematic diagram of the structure of the suction tube in the suction piece provided in this application;

[0027] Figure 9 This is a schematic structural diagram of the covering layer of the suction tube in the suction piece provided in this application.

[0028] Description of reference numerals:

[0029] 1-suction tube; 11-smoothing layer; 12-supporting layer; 13-coating layer; 131-first coating section; 132-second coating section; 133-third coating section; 134-fourth coating section; 135-fifth coating section; 136-sixth coating section; 14-suction channel; 2-filling body; 21-filling space; 3-conveying component; 31-extension section; 32-connecting section; 33-conveying member; 34-connecting member; 35-connecting gap; 36-adhesive layer; 37-conveying channel; 38-long axis; 39-short axis; 4-developing member; 5-guide catheter; 51-guide channel; 6-connecting seat; 7-connecting valve; 71-side branch passage; Y-radial direction; Z-axial direction. DETAILED DESCRIPTION

[0030] To make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the specific technical solutions of the present application will be further described in detail below in conjunction with the drawings in the embodiments of the present application. The following embodiments are used to illustrate the present application but are not intended to limit the scope of the present application.

[0031] In the embodiments of this application, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of this application, unless otherwise specified, "multiple" means two or more.

[0032] In addition, in the embodiments of the present application, directional terms such as "up", "down", "left" and "right" are defined relative to the orientation of the components in the drawings. It should be understood that these directional terms are relative concepts. They are used for relative description and clarification, and they may change accordingly according to changes in the orientation of the components in the drawings.

[0033] In the embodiments of the present application, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense. For example, "connection" can be a fixed connection, a detachable connection, or an integrated connection; it can be a direct connection or an indirect connection through an intermediate medium.

[0034] In the embodiments of the present application, the terms "comprises," "comprising," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not preclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0035] In the embodiments of this application, words such as "exemplary" or "for example" are used to indicate examples, illustrations, or descriptions. Any embodiment or design described as "exemplary" or "for example" in the embodiments of this application should not be interpreted as being preferred or advantageous over other embodiments or designs. Rather, the use of words such as "exemplary" or "for example" is intended to present the relevant concepts in a concrete manner.

[0036] Endovascular treatment for acute ischemic stroke involves removing thrombi from blood vessels via a suction catheter, particularly in highly tortuous and narrow blood vessels such as cerebral vessels. Removing thrombi from blood vessels via a suction catheter has a good therapeutic effect.

[0037] In complex vascular environments, the applicability of the suction catheters provided by related technologies has significant defects. Since the intracranial blood vessels that need to be entered are small in size and have complex anatomical structures, the size of the suction catheter is limited, so that the distal end of the suction catheter has a smaller caliber. Although the smaller caliber of the suction catheter facilitates entry into the intracranial blood vessels, there is a problem of being unable to provide effective suction force. Although some suction catheters adopt a structure with a larger inner lumen at the proximal end and a smaller inner lumen at the distal end, they are limited by the inner diameter of the guide catheter. The inner and outer diameters of the proximal end of such suction catheters are still smaller than the inner lumen of the guide catheter.

[0038] The embodiment of the present application provides a suction piece, which can keep the outer diameter of the suction piece small, which is conducive to fully utilizing the larger lumen of the guide catheter to increase the suction flow rate and suction force. Figure 1 、 Figure 2 and Figure 3 , Figure 1 A schematic diagram of the structure of the suction system provided in this application, Figure 2 This is a schematic diagram of the structure of the suction piece provided in this application. Figure 3 Provided for this application Figure 2 Enlarged schematic diagram of part A.

[0039] The suction device provided in the embodiment of the present application includes: a suction tube 1, a filling body 2, a conveying assembly 3, and a developing assembly 4. The suction tube 1 has a suction channel 14; the filling body 2 is sleeved on the outer wall of the suction tube 1 and encloses a filling space 21 with the outer wall of the suction tube 1. The filling body 2 is capable of elastic deformation; the conveying assembly 3 is connected to the tube wall of the suction tube 1, and the portion of the conveying assembly 3 connected to the tube wall extends along the axial direction Z of the suction tube 1 to a position corresponding to the filling body 2. The conveying assembly 3 has a conveying channel 37, which is connected to the filling space 21; and the developing assembly 4 is disposed at the distal end of the suction tube 1 and is used to display the position of the distal end of the suction tube 1.

[0040] In the embodiment of the present application, the guide catheter 5 can be inserted into the body, and the suction tube 1 can be inserted into a blood vessel within the body along the inner lumen of the guide catheter 5 to suction the blood vessel through the suction tube 1, thereby aspirating the blood clots and the like within the blood vessel out of the body. For example, the suction tube 1 can be configured as a cylindrical, long tubular structure, with the cavity within the tubular suction tube 1 serving as the suction channel 14. By suctioning the suction channel 14, a negative pressure can be generated within the suction channel 14.

[0041] It should be noted that the distal end and proximal end described in this application are both based on the axial direction Z of the suction tube 1 as the extension direction. The distal end is the end of the suction piece away from the operator, that is, the distal end is the end that first enters the body or approaches the body, and the proximal end is the end of the suction piece close to the operator, that is, the proximal end is the end that last enters the body or moves away from the body. For example, Figure 2 As shown in Figure 2 The right side of Figure 2 Center left.

[0042] In the embodiment of the present application, after the guide catheter 5 and the suction tube 1 are inserted into the blood vessels in the body, there is a gap between the suction tube 1 and the guide catheter 5. A filling body 2 can be set on the suction tube 1 to fill and seal the gap between the suction tube 1 and the guide catheter 5 through the filling body 2, so that a sealed environment is formed between the suction tube 1 and the blood vessel, so that a larger negative pressure can be formed in the suction channel 14.

[0043] For example, Figure 3As shown, a filling body 2 can be provided at the proximal end of the suction tube 1, or at the distal end of the suction tube 1. The filling body 2 can be made of a compliant or semi-compliant material so that the filling body 2 can easily produce elastic deformation. For example, the filling body 2 can be made of materials such as thermoplastic polyurethane elastomer (TPU) or silicone. The filling body 2 can be provided as an annular thin sheet structure, and the annular filling body 2 can be sleeved on the outer wall of the suction tube 1, and the two side edges of the filling body 2 can be sealed to the outer wall of the suction tube 1. For example, the filling body 2 can be sealed to the suction tube 1 by laser welding or adhesive bonding. In this way, a filling space 21 can be enclosed on the outer wall of the suction tube 1 by the filling body 2, and the volume of the filling body 2 can be changed by transporting fluids such as gas and liquid into the filling space 21, so that the gap between the suction tube 1 and the guide catheter 5 can be blocked by the filling body 2.

[0044] In the embodiment of the present application, the fluid can be transported into the filling space 21 through the transport component 3. For example, the transport component 3 can be set to a tubular structure so that there is a cavity in the transport component 3 that serves as the transport channel 37.

[0045] For example, Figure 2 and Figure 3 As shown, a portion of the conveying assembly 3 can be fixed to the wall of the suction tube 1, and the portion of the conveying assembly 3 fixed to the wall of the suction tube 1 can extend along the axial direction Z of the suction tube 1. For example, a groove extending along the axial direction Z of the suction tube 1 can be provided on the wall of the proximal end of the suction tube 1. The groove matches the conveying assembly 3. The entire conveying assembly 3 or a portion of the conveying assembly 3 along the radial direction Y can then be embedded into the groove at the proximal end of the suction tube 1. For example, the conveying assembly 3 and the wall can be sealed by bonding, laser welding, or the like.

[0046] In another example, the delivery component 3 can be extended within the tube wall to a position corresponding to the filling body 2. For example, a groove on the tube wall can be extended into the filling space 21, and the edge of the filling body 2 and the adjacent portion of the delivery component 3 can be sealed by bonding, laser welding, thermal lamination, etc., so that the distal end of the delivery component 3 can be extended into the filling space 21, thereby connecting the delivery channel 37 and the filling space 21.

[0047] In an embodiment of the present application, a developing member 4 can be provided at the distal end of the suction tube 1. For example, the developing member 4 can be made of a material that is opaque to X-rays, such as platinum-tungsten alloy, tantalum, gold, or other metals. The developing member 4 can be provided in a semi-annular or complete annular shape, and the developing member 4 can be embedded in the distal end of the suction tube 1. For example, the distance between the distal end of the developing member 4 and the distal end of the suction tube 1 can be set to 0.5 mm. In this way, after the suction tube 1 is inserted into the body, the position of the distal end of the suction tube 1 in the body can be quickly determined through the developing member 4.

[0048] The suction piece provided in the embodiment of the present application has a filling body 2 provided on the outer wall of the suction tube 1. The volume of the filling body 2 can be changed by transporting fluid into the filling space 21 enclosed by the filling body 2 and the suction tube 1. In this way, the gap between the suction tube 1 and the guide catheter 5 can be filled by the filling body 2. When the guide catheter 5 is suctioned, it is beneficial to generate a relatively high negative pressure in the suction tube 1. In addition, a developing component 4 is provided at the distal end of the suction tube 1. The developing component 4 can be used to quickly and in real time determine the specific position of the distal end of the suction tube 1 in the blood vessel, making it easier for doctors to confirm whether the distal end of the suction tube 1 is close to a thrombus. At the same time, the conveying component 3 is connected to the wall of the suction tube 1 along the axial direction Z of the suction tube 1, and the conveying component 3 is extended to a position corresponding to the filling space 21. The fluid can be transported into the filling space 21 through the conveying channel 37 of the conveying component 3. Such a structural setting can utilize the tube wall of the suction tube 1 to provide an installation position for the conveying component 3. There is no need to fit the conveying component 3 to the inner wall or outer wall of the suction tube 1, so that the conveying component 3 does not completely protrude from the outer wall of the suction tube 1, and there is no need to change the overall radial Y dimension of the suction piece, thereby allowing the suction piece to maintain a smaller outer diameter, which is conducive to making full use of the larger tube cavity of the guide catheter 5 to increase the suction flow rate and suction force.

[0049] In some possible embodiments of the present application, along the axial direction Z of the suction pipe 1, the conveying assembly 3 includes an extension section 31 and a connecting section 32, the extension section 31 is used to connect to the pressure source, and at least a portion of the connecting section 32 is penetrated into the tube wall along the axial direction Z of the suction pipe 1, and a connecting gap 35 is provided on the tube wall and the connecting section 32, and the conveying channel 37 and the filling space 21 are connected through the connecting gap 35.

[0050] In the embodiment of the present application, the portion where the conveying assembly 3 connects to the suction pipe 1 can be disposed within the wall of the suction pipe 1. That is, along the axial direction Z of the suction pipe 1, the extending section 31 of the conveying assembly 3 can be located outside the suction pipe 1, while the entirety or a portion of the connecting section 32 of the conveying assembly 3 can be located within the wall of the suction pipe 1.

[0051] For example, the length of the extension section 31 can be made longer than the length of the guide catheter 5. After the extension section 31 passes through the guide catheter 5, the proximal end of the extension section 31 can be located outside the proximal end of the guide catheter 5. For example, a connector 6 connected to a pressure source can be provided at the proximal end of the extension section 31. The pressure source can be a filling device such as a syringe, a ram pump, etc. The connector 6 can be a device that facilitates sealing and plugging. For example, the connector 6 can be a needle holder that matches the syringe barrel, so as to facilitate connecting the front end of the syringe barrel to the needle holder. The filling space 21 can be filled with air or liquid using a syringe.

[0052] Another example, such as Figure 3 As shown, the distal end of the connecting section 32 can be inserted into the wall of the proximal end of the suction tube 1. For example, a blind hole extending along the axial direction Z of the suction tube 1 can be provided in the wall of the proximal end of the suction tube 1. This blind hole matches the connecting section 32. The distal end of the connecting section 32 can then be inserted into the blind hole in the wall from the end face of the proximal end of the suction tube 1. The connecting section 32 can then be sealed to the wall by bonding, laser welding, or other methods. In this way, the connecting section 32 is inserted into the wall of the suction tube 1 along the axial direction Z of the suction tube 1.

[0053] Another example, such as Figure 3 As shown, the blind hole in the tube wall can be extended to the location of the filling space 21. In this way, a connecting notch 35 can be provided in the tube wall. The connecting notch 35 can be located on the outer wall at the distal end of the blind hole. If the connecting section 32 is inserted into the bottom of the blind hole, the connecting notch 35 can also be provided in the connecting section 32. The connecting notch 35 in the tube wall and the connecting notch 35 in the connecting section 32 can overlap along the radial direction Y of the suction tube 1. This allows the delivery channel 37 and the filling space 21 to communicate through the connecting notch 35.

[0054] In the above embodiment, since the delivery assembly 3 includes an extension section 31 and a connection section 32, it is convenient to connect the extension section 31 to the pressure source, and the connection section 32 to the suction tube 1. Furthermore, at least a portion of the connection section 32 is disposed within the wall of the suction tube 1 along the axial direction Z of the suction tube 1, allowing the wall to accommodate and install the connection section 32. This allows the connection section 32, which is connected to the wall of the suction tube 1, to be completely concealed within the wall of the suction tube 1. This minimizes the space occupied by the connection section 32 within or outside the wall, allowing the radial Y dimension of the suction member (ignored here because the volume of the filler 2 can vary) to be equal to the radial Y dimension of the suction tube 1. Thus, if the inner lumen of the guide catheter 5 is fixed in size, the suction tube 1 can be provided with a larger inner diameter, which in turn allows the suction member to have a larger inner diameter suction channel 14, thereby facilitating the generation of a greater negative suction pressure.

[0055] In some possible embodiments of the present application, refer to Figure 4 、 Figure 5 、 Figure 6 and Figure 7 , Figure 4 Provided for this application Figure 3 Schematic diagram of the cross-sectional structure along the BB direction, Figure 5 Provided for this application Figure 3 Schematic diagram of the cross-sectional structure along the CC direction, Figure 6 This is a schematic cross-sectional view of the conveying member in the suction member provided in this application. Figure 7 Provided for this application Figure 6 Schematic diagram of the cross-sectional structure along the DD direction. The cross section of at least a portion of the connecting section 32 is flat ring-shaped. The length of the long axis 38 of the flat ring is greater than the length of the short axis 39 of the flat ring, and the length of the long axis 38 is greater than the thickness of the tube wall. The short axis 39 is parallel to the radial direction Y of the suction tube 1, and the long axis 38 is perpendicular to the radial direction Y of the suction tube 1.

[0056] In the embodiment of this application, Figure 3 、 Figure 4 and Figure 5 As shown, the portion of the connecting section 32 inserted into the wall of the suction pipe 1 can be configured as a flat cylinder, or the entire connecting section 32 can be configured as a flat cylinder. That is, the cross section of the portion of the connecting section 32 inserted into the wall of the suction pipe 1 is approximately elliptical.

[0057] For example, the conveying component 3 can be first set to a cylindrical shape, and the distal end of the conveying component 3 can be punched into a flat ring shape by punching, that is, at least a portion of the connecting section 32 can be punched into a flat cylindrical shape with a flat ring cross section. Figure 4 and Figure 5 As shown, the flat ring can be understood as a ring formed by two arc segments and two straight-side segments, both of which can be semicircular arc segments. One straight-side segment connects the corresponding sides of the two semicircular arc segments, and the other straight-side segment connects the other corresponding sides of the two semicircular arc segments, thereby forming a flat cylindrical shape. In this way, the major axis 38 of the cross section of the flat cylindrical flat ring includes the length of the straight-side segment and the radius of the two semicircular arc segments, and the minor axis 39 of the cross section of the flat cylindrical flat ring includes the radius of the semicircular arc segments.

[0058] Another example, such as Figure 5 As shown, when the flat cylindrical connecting section 32 is inserted into the wall of the suction pipe 1, the minor axis 39 of the flat cylindrical connecting section 32 can be parallel or nearly parallel to the radial direction Y of the cylindrical suction pipe 1, while the major axis 38 of the flat cylindrical connecting section 32 can be perpendicular or nearly perpendicular to the radial direction Y of the cylindrical suction pipe 1. In this way, the major axis 38 of the flat cylindrical connecting section 32 can extend along the circumferential direction of the suction pipe 1.

[0059] Another example, such as Figure 7 As shown, the length of the minor axis 39 of the flat cylindrical portion of the connecting section 32 can be set to be less than or equal to 0.15 mm; and / or the length of the major axis 38 of the flat cylindrical portion of the connecting section 32 can be set to be less than or equal to 0.6 mm. For example, when the wall thickness of the suction tube 1 is close to 0.4 mm and the outer diameter of the suction tube 1 is close to 2 mm, the length of the minor axis 39 of the flat cylindrical portion of the connecting section 32 can be set to 0.15 mm, 0.13 mm, 0.11 mm, etc., so that the length of the minor axis 39 of the flat cylindrical portion of the connecting section 32 is less than one-third of the wall thickness of the suction tube 1. The length of the major axis 38 of the flat cylindrical portion of the connecting section 32 can be set to 0.6 mm, 0.5 mm, 0.4 mm, etc., so that the length of the major axis 38 of the flat cylindrical portion of the connecting section 32 is less than 0.6 mm but greater than the wall thickness of the suction tube 1. The wall thickness of the flat cylindrical portion of the connecting section 32 can be set to 0.025 mm, 0.023 mm, or 0.02 mm, etc. In this way, after the flat cylindrical portion of the connecting section 32 is arranged in the tube wall of the suction tube 1, the portion of the tube wall surrounding the flat cylindrical portion of the connecting section 32 can have a sufficient thickness, so that the strength of the suction tube 1 can meet the use requirements, which is conducive to improving the reliability of the suction piece.

[0060] In the above embodiment, since the portion where the connecting section 32 is connected to the tube wall of the suction tube 1 is set to be a flat cylindrical shape with a flat ring cross section, and the short axis 39 of the flat ring is parallel to the radial direction Y of the suction tube 1, the long axis 38 of the flat cylindrical connecting section 32 can be extended along the circumference of the suction tube 1 inside the tube wall, thereby reducing the installation space occupied by the flat cylindrical connecting section 32 along the radial direction Y of the suction tube 1, which not only allows the suction tube 1 to maintain a smaller wall thickness, but also allows the connecting section 32 to have a larger cross-sectional area, thereby allowing the conveying channel 37 of the conveying component 3 to have a larger flow area, thereby facilitating the delivery of the fluid to the filling space 21.

[0061] In some possible embodiments of the present application, Figure 6 As shown, the outer diameter of the extension section 31 is greater than the outer diameter of the connecting section 32; and / or, the outer diameter of the extension section 31 is greater than or equal to 0.5 mm, and the outer diameter of the connecting section 32 is less than or equal to 0.4 mm.

[0062] In the embodiment of the present application, the conveying component 3 can be configured to include a variable diameter structure including at least two parts with different pipe diameters. For example, the entire extension section 31 can be configured to be a slender cylindrical shape with a relatively thick outer diameter, while the end of the connecting section 32 connected to the extension section 31 (the proximal end of the connecting section 32) can be configured to be a cylindrical shape with a relatively thin outer diameter, and the end of the connecting section 32 away from the extension section 31 (the distal end of the connecting section 32) can be configured to be a flat cylindrical shape with a relatively thin outer diameter. In other words, the outer diameter of the extension section 31 is larger than the outer diameter of the connecting section 32, and the wall thickness of the extension section 31 and the wall thickness of the connecting section 32 can be the same or different. For example, the wall thickness of the extension section 31 is configured to be larger than the wall thickness of the connecting section 32.

[0063] For example, the outer diameter of the extension section 31 can be set to 0.5 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1 mm, etc., wherein the outer diameter of the extension section 31 needs to be smaller than the inner diameter of the lumen of the guide catheter 5, and the outer diameter of the extension section 31 can be less than or equal to half the inner diameter of the lumen of the guide catheter 5. For example, the outer diameter of the extension section 31 is set to 0.5 mm, the inner diameter of the extension section 31 is set to 0.3 mm, and the wall thickness of the extension section 31 is set to 0.1 mm.

[0064] As another example, the outer diameter of the cylindrical portion of the connecting section 32 can be set to 0.4 mm, 0.38 mm, 0.35 mm, 0.3 mm, 0.28 mm, or 0.25 mm, etc., wherein the outer diameter of the cylindrical portion of the connecting section 32 needs to be larger than the minor axis 39 of the flat cylindrical portion of the connecting section 32. For example, the outer diameter of the cylindrical portion of the connecting section 32 can be set to 0.4 mm, and the inner diameter of the cylindrical portion of the connecting section 32 can be set to 0.3 mm, so that the wall thickness of the cylindrical portion of the connecting section 32 is 0.05 mm.

[0065] As another example, the minor axis 39 of the flat cylindrical portion of the connecting section 32 can be set to 0.15 mm, the major axis 38 of the flat cylindrical portion of the connecting section 32 can be set to 0.6 mm, and the wall thickness of the flat cylindrical portion of the connecting section 32 can be set to 0.025 mm. The cylindrical shape of the connecting section 32 and the extension section 31 can be connected by a truncated cone-shaped ring, and the distal end of the connecting section 32 can be stamped into a flat ring by stamping, and the wall thickness of the flat ring portion can be reduced by stamping.

[0066] In the above embodiment, since the outer diameter of the extension section 31 is greater than that of the connecting section 32, the wall thickness of the extension section 31 can be greater than that of the connecting section 32. This provides the extension section 31 with greater strength, thereby reducing the risk of damage to the extension section 31 when connected to the pressure source. The smaller outer diameter of the connecting section 32 allows for a larger delivery channel 37 by reducing its wall thickness. Furthermore, the connecting section 32 is inserted and fixed within the wall of the suction pipe 1, thus reducing the risk of damage to the connecting section 32.

[0067] In some possible embodiments of the present application, Figure 3 and Figure 4 As shown, the conveying assembly 3 includes a conveying member 33 and a connecting member 34. The distal end of the conveying member 33 is sealedly connected to the proximal end of the connecting member 34. A portion of the conveying member 33 and the connecting member 34 form a connecting section 32. The hardness of the connecting member 34 is less than that of the conveying member 33. A connecting notch 35 is provided on the connecting member 34.

[0068] In the embodiment of the present application, the conveying assembly 3 can be set to a structure including a conveying member 33 and a connecting member 34, that is, the conveying assembly 3 is formed by connecting the conveying member 33 and the connecting member 34.

[0069] For example, Figure 6 As shown, the conveying member 33 can be made of metal materials. For example, the conveying member 33 can be made of 304 stainless steel or nickel-titanium alloy. The conveying member 33 can be configured as an elongated hypotube, and the hypotube can be configured as a cylindrical structure with a variable diameter. That is, the surface of the hypotube has micro-engineering properties. For example, specific notches or spiral patterns can be provided on the surface of the hypotube to enhance the flexibility and thrust transmission efficiency of the hypotube. The portion of the conveying member 33 with a larger outer diameter can be used as the extension section 31 of the conveying assembly 3, while the portion of the conveying member 33 with a smaller outer diameter can be used as part of the connecting section 32 of the conveying assembly 3. The portion of the conveying member 33 with a smaller outer diameter can be stamped so that the distal end of the conveying member 33 is formed into a flat cylindrical shape.

[0070] Another example, such as Figure 3 As shown, the connector 34 can be made of a material with a lower hardness than the conveying member 33. For example, the connector 34 can be made of a polymer material and made into a thin film. For example, the polymer can be polyimide (PI). The PI can be made into a cylinder that matches the flat cylindrical shape of the distal end of the conveying member 33. For example, the PI can be made into a cylindrical PI tube with an outer diameter of 0.6 mm and an inner diameter of 0.5 mm. The cylindrical PI tube is then sealed and connected to the flat cylindrical portion of the distal end of the conveying member 33, and then the PI tube is also flattened into a flat cylindrical shape. A connecting notch 35 can be provided on the PI tube to connect the conveying channel 37 with the filling space 21 through the connecting notch 35.

[0071] Another example, such as Figure 3 and Figure 4 As shown, the proximal end of the connecting member 34 can be sleeved onto the flat cylindrical distal end of the conveying member 33. For example, the connecting member 34 can be fixedly and hermetically connected to the distal end of the conveying member 33 by bonding. Adhesive can be applied to the outer wall of the distal end of the conveying member 33, and then the connecting member 34 is sleeved onto the distal end of the conveying member 33. After the adhesive is cured, an adhesive layer 36 is formed. The flattened connecting member 34 and the distal end of the flattened conveying member 33 can be inserted into a blind hole in the wall of the suction tube 1, and then the flattened connecting member 34 and the distal end of the flattened conveying member 33 are sealed and fixedly connected to the suction tube 1 through a thermal bonding process.

[0072] In the above embodiment, since the conveying component 3 includes a conveying member 33 and a connecting member 34, the extension section 31 of the conveying component 3 can have higher strength by selecting the materials of the conveying member 33 and the connecting member 34, and it is convenient to seal the connecting member 34 located at the far end of the conveying component 3 with the suction tube 1.

[0073] In some possible embodiments of the present application, refer to Figure 8 and Figure 9 , Figure 8 This is a schematic diagram of the structure of the suction tube in the suction piece provided in this application. Figure 9 This is a schematic diagram of the structure of the coating layer 13 of the suction tube in the suction device provided in this application. The suction tube 1 includes a coating layer 13, a support layer 12, and a smooth layer 11. The smooth layer 11 encloses a suction channel 14. The support layer 12 is coated on the smooth layer 11, and the coating layer 13 is coated on the support layer 12.

[0074] In the embodiment of the present application, the suction tube 1 can be configured as an elongated cylindrical shape. From the inside out, the suction tube 1 can include a smooth layer 11, a support layer 12, and a coating layer 13. The smooth layer 11 can reduce the resistance to the flow of blood clots, the support layer 12 can provide sufficient strength for the suction tube 1, and the coating layer 13 can provide high toughness for the suction tube 1. For example, the length of the suction tube 1 can be set to 250 mm to 450 mm.

[0075] For example, the smooth layer 11 may be made of a material with a low friction coefficient, such as polytetrafluoroethylene (PTFE) or high-density polyethylene (HDPE), and may be cylindrical with an inner diameter of 1.04 mm to 2.24 mm.

[0076] In another example, the support layer 12 may be made of a material having a strength greater than that of at least one of the coating layer 13 and the smooth layer 11. For example, the support layer 12 may be made of a metal material such as 304 stainless steel, nickel titanium alloy, platinum tungsten alloy, etc. Figure 8 As shown, the support layer 12 can be configured as a coil spring structure. For example, the support layer 12 can be wound with 304 stainless steel wire. The diameter of the 304 stainless steel wire can be 0.05 mm, and the pitch of the wound stainless steel coil spring can be 0.09 mm. The distal end of the stainless steel coil spring can be fixed by laser welding. The developing element 4 can also be welded to the stainless steel coil spring. The support layer 12 can also be configured as a metal braided structure. The support layer 12 made of metal material can serve as the developing element 4. The specific structure of the support layer 12 is not limited in this embodiment of the application.

[0077] In another example, the coating layer 13 may be made of a material with high toughness and elasticity. For example, the coating layer 13 may be made of a polymer, such as polyether block polyamide (PEBAX), nylon, polyurethane elastomer (TPU), etc.

[0078] Another example, such as Figure 9 As shown, the coating layer 13 can be configured as at least two coating segments, with the at least two coating segments sequentially distributed along the axial direction Z of the suction tube 1. The hardness of the at least two coating segments decreases from the proximal end to the distal end of the suction tube 1. In other words, different polymers can be used for the different coating segments, so that the hardness of the coating layer 13 gradually decreases from the proximal end to the distal end. For example, the inner diameter of the smoothing layer 11 can be set to 1.78 mm, and the outer diameter of the coating layer 13 can be set to 2.17 mm, resulting in a wall thickness of 0.39 mm for the suction tube 1, a length of 420 mm for the suction tube 1, and a length of 1500 mm for the entire suction member. This means that the length of the extension section 31 of the conveying assembly 3 is approximately 1080 mm.

[0079] For another example, the coating layer 13 may be configured to include six coating segments. From the proximal end to the distal end of the suction tube 1 , the six coating segments are made of nylon 12, pebax6333, pebax5533, pebax4033, pebax3533, and TPU80A, respectively. Specifically, the first coating section 131 is made of nylon 12, has a length of 150 mm, and a Shore hardness of 70D to 80D; the second coating section 132 is made of pebax 6333, has a length of 20 mm, and a Shore hardness of 62D to 65D; the third coating section 133 is made of pebax 5533, has a length of 20 mm, and a Shore hardness of 52D to 56D; the fourth coating section 134 is made of pebax 4033, has a length of 20 mm, and a Shore hardness of 39D to 43D; the fifth coating section 135 is made of pebax 3533, has a length of 20 mm, and a Shore hardness of 30D to 34D; and the sixth coating section 136 is made of TPU 80A, has a length of 20 mm, and a Shore hardness of 18D to 23D. The total length of the coating layer 13 is 420 mm. The distance between the distal end of the developing member 4 and the distal end of the suction tube 1 can be 0.5 mm.

[0080] In this way, the proximal end of the coating layer 13 can have a higher hardness, providing stronger support for the suction tube 1, allowing the proximal end of the suction tube 1 to easily maintain its shape and facilitate application of a propulsive force to the suction tube 1. The distal end of the coating layer 13 can also have a lower hardness, making the distal end of the suction tube 1 relatively flexible, thereby making it easier to bend and deform the distal end of the suction tube 1, facilitating insertion of the suction tube 1 into a blood vessel in the body.

[0081] It should be noted that the hardness and length measurements of the above-mentioned coating sections are all measured at room temperature and pressure (20°C, one standard atmospheric pressure). The hardness can be measured using a D-type Shore hardness tester, and the length can be measured using a millimeter tape measure.

[0082] In the above embodiment, since the suction tube 1 includes the coating layer 13, the support layer 12 and the smooth layer 11, by selecting the respective materials of the coating layer 13, the support layer 12 and the smooth layer 11, the liquid such as thrombus can have good fluidity in the suction tube 1, and the distal end of the suction tube 1 can have a lower hardness to facilitate intervention in a curved blood vessel, and the proximal end of the suction tube 1 can also have good bending and folding resistance to facilitate applying a driving force to the suction tube 1, and the suction tube 1 can also have a higher strength, so that it can resist the negative pressure force during suction and keep the suction channel 14 unobstructed.

[0083] In addition, the present application also provides a suction system, such as Figure 1As shown, the suction system includes: a guide catheter 5, a filling device, a suction apparatus, and a suction member provided by any of the above-mentioned embodiments. The guide catheter 5 has a guide channel 51, the inner diameter of which is larger than the outer diameter of the suction tube 1. The filling device is connected to the delivery assembly, and the filling device fills the filling space 21 with fluid via the delivery assembly 3, enabling the filler 2 to fill the gap between the suction tube 1 and the guide catheter 5. The suction tube 1 has a suction channel 14, which is connected to the guide channel 51. The suction apparatus aspirates the clot at the distal end of the suction tube 1 through the suction channel 14 and the guide channel 51.

[0084] In this embodiment of the present application, the guide catheter 5 is used to guide the suction device into the body. For example, the guide catheter 5 can be configured as a cylindrical tube with a lumen, with the lumen of the guide catheter 5 serving as a guide channel 51 for the suction tube 1. For example, the inner diameter of the lumen of the guide catheter 5 can be set to 2.23 mm. The proximal end of the delivery assembly 3 can be passed through the proximal end of the guide catheter 5.

[0085] like Figure 1 As shown, when the filling body 2 is not filled, the suction piece can slide in the guide channel 51 along the axial direction Z; when the filling body 2 is filled, the filling body 2 expands and abuts against the inner wall of the guide catheter 5 to block the gap between the outer wall of the suction tube 1 and the inner wall of the guide catheter 5, so that the suction channel 14 can be connected with the guide channel 51.

[0086] For example, a connecting valve 7 can be provided at the proximal end of the guide catheter 5. The connecting valve 7 has a side branch passage 71. The side branch passage 71 communicates with the guide channel 51 of the guide catheter 5, and thus with the suction channel 14 of the suction tube 1. A one-way valve can be provided within the side branch passage 71. The one-way valve allows flow from the suction channel 14 to the side branch passage 71, but is normally closed from the side branch passage 71 to the suction channel 14. The side branch passage 71 can also be connected to a heparin cap to prevent the filled medium from flowing out of the side branch passage 71, thereby preventing backflow.

[0087] In this way, when using the suction system, the distal end of the guide catheter 5 can be first placed into the blood vessel in the body, and then the suction tube 1 can be inserted into the blood vessel along the guide channel 51 of the guide catheter 5 until the distal end of the suction tube 1 reaches the location of the thrombus. Then the proximal end of the guide catheter 5 is sealed, and the filling device (such as a syringe) is connected to the delivery component 3 to deliver fluid into the filling body 2 so that the filling body 2 expands and fills the gap between the suction tube 1 and the guide catheter 5. Corresponding to the heparin cap setting, a needle syringe can be used to insert the heparin cap to deliver fluid, so that the filling body 2 expands. Corresponding to the one-way valve setting, a syringe with a Luer connector can be used to connect the one-way valve to deliver fluid, so that the filling body 2 expands. Finally, negative pressure is provided by a suction device (such as a syringe) connected to the side branch passage 71 of the guide catheter 5 to aspirate the clot (such as a thrombus, broken plaque).

[0088] Table 1

[0089]

[0090] As another example, referring to Table 1, Table 1 shows the test data of the suction force of the suction system using the suction member provided in the embodiment of the present application and the suction system in the related art. At room temperature and pressure (20°C, one standard atmospheric pressure), a 60ml syringe was used to suction the ACE68 thrombus aspiration catheter of Jianshi Medical, the Sofia6PLUS aspiration catheter of MicroVention, the Catalyst6 aspiration catheter of Stryker, and the aspiration catheter provided in the embodiment of the present application, respectively, to form a negative pressure in the aspiration catheter.

[0091] As can be seen from Table 1, the suction negative pressure of the suction system using the suction piece provided in the embodiment of the present application reaches 60.75 mmHg, while the suction negative pressure of the other three existing suction catheters is about 26 mmHg. The suction negative pressure of the suction system of the present application is at least 2.3 times the suction negative pressure of the other three existing suction catheters. When the tip areas of the tips of the suction pieces (the other three existing suction catheters) are similar, the tip force of the tip of the suction piece provided in the embodiment of the present application reaches 51.2 g, while the tip force of the tips of the other three existing suction catheters is about 21 g. The tip force of the tip of the suction piece provided in the embodiment of the present application is at least 2.4 times the tip force of the tips of the other three existing suction catheters. It can be seen from this that when the suction piece provided in the embodiment of the present application is used to aspirate the clot in the patient's blood vessel, a greater suction force can be generated than that of the suction catheter in the related art.

[0092] The suction system provided in the embodiment of the present application includes the suction piece provided in any one of the above embodiments. Therefore, the suction piece can maintain a smaller outer diameter, which is conducive to fully utilizing the larger lumen of the guide catheter 5 to increase the suction flow rate and suction force.

[0093] The present application provides a method for performing thrombus aspiration using the above-mentioned suction system, which includes: using the guide catheter 5 that extends into the patient's blood vessel in a percutaneous structure to guide the suction piece, and after the filling body 2 expands, it abuts against the inner wall of the guide channel 51 and maintains a sealing effect, and suction is applied through the guide channel 51 and the suction channel 14 to aspirate the fluid out of the guide catheter 5, thereby removing the clot from the blood vessel.

[0094] The above embodiments are intended only to illustrate the technical solutions of the present application, and are not intended to limit them. Although the present application has been described in detail with reference to the above embodiments, those skilled in the art should understand that they may still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. Such modifications or replacements do not deviate from the essence of the corresponding technical solutions within the scope of the technical solutions of the embodiments of the present application, and they should all be included within the scope of the specification of the present application. In particular, as long as there is no structural conflict, the various technical features mentioned in the various embodiments may be combined in any manner.

Claims

1. A suction piece, characterized in that: include: Suction tube; a filling body, the filling body being sleeved on the outer wall of the suction tube and enclosing the filling body and the outer wall of the suction tube to form a filling space, the filling body being capable of elastic deformation; A conveying component is connected to the tube wall of the suction tube, and the part of the conveying component connected to the tube wall extends along the axial direction of the suction tube to a position corresponding to the filling body. The conveying component has a conveying channel, which is connected to the filling space.

2. The suction piece according to claim 1, characterized in that Along the axial direction of the suction pipe, the conveying assembly includes an extension section and a connecting section, the extension section is used to connect to the pressure source, at least a portion of the connecting section is penetrated into the tube wall along the axial direction of the suction pipe, and a connecting gap is provided on the tube wall, and the conveying channel and the filling space are connected through the connecting gap.

3. The suction piece according to claim 2, characterized in that The cross-section of at least a portion of the connecting section is in the form of a flat ring, the length of the major axis of the flat ring is greater than the length of the minor axis of the flat ring, and the length of the major axis is greater than the thickness of the tube wall, the minor axis is parallel to the radial direction of the suction tube, and the major axis is perpendicular to the minor axis.

4. The suction piece according to claim 3, characterized in that The length of the minor axis is less than or equal to 0.15 mm; And / or, the length of the major axis is less than or equal to 0.6 mm.

5. The suction piece according to claim 2, characterized in that The outer diameter of the extension section is greater than the outer diameter of the connecting section; And / or, the outer diameter of the extension section is greater than or equal to 0.5 mm, and the outer diameter of the connecting section is less than or equal to 0.4 mm.

6. The suction piece according to any one of claims 2 to 5, characterized in that The conveying assembly includes a conveying member and a connecting member, the distal end of the conveying member is sealedly connected to the proximal end of the connecting member, a portion of the conveying member and the connecting member form the connecting section, the hardness of the connecting member is less than the hardness of the conveying member, and the connecting member has the connecting gap.

7. The suction piece according to claim 6, characterized in that The proximal end of the connecting member is sleeved on the distal end of the conveying member and is bonded to the distal end of the conveying member.

8. The suction piece according to any one of claims 1 to 5, characterized in that The suction pipe includes a coating layer, a support layer and a smooth layer. The smooth layer encloses a suction channel. The support layer coats the smooth layer, and the coating layer coats the support layer.

9. The suction piece according to claim 8, characterized in that The support layer has a strength greater than a strength of at least one of the cover layer and the slippery layer.

10. The suction piece according to claim 8, characterized in that The coating layer includes at least two coating segments, which are sequentially distributed along the axial direction of the suction tube. The hardness of the at least two coating segments decreases sequentially from the proximal end to the distal end of the suction tube.

11. A suction system, characterized in that: include: A guide catheter, an inflation device, a suction apparatus, and a suction piece according to any one of claims 1 to 10; The guide catheter has a guide channel, the inner diameter of which is larger than the outer diameter of the suction tube; the filling device is connected to the conveying component, and the filling device fills the fluid into the filling space through the conveying component, so that the filling body can fill the gap between the suction tube and the guide catheter; the suction tube has a suction channel, which is connected to the guide channel, and the suction device sucks the clot at the distal end of the suction tube through the suction channel and the guide channel.

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