Fluid control device with double pipe bodies
By designing a fluid control device with a dual-tube structure, utilizing the gradually enlarging through-hole on the first tube and the movable second tube, the problems of segmental angiography and intimal damage in the diagnosis and treatment of vascular lesions using existing catheters are solved, achieving uniform fluid delivery and reducing damage.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SHENZHEN INSIGHT MED CO LTD
- Filing Date
- 2024-10-29
- Publication Date
- 2026-05-01
AI Technical Summary
Existing angiography catheters have problems in the diagnosis and treatment of vascular lesions, such as difficulty in segmental angiography, inflexible operation, easy intimal damage, and inability to distinguish between true and false lumens. This may lead to surgical failure, especially in the endovascular treatment of aortic dissection.
A fluid control device with a dual-tube structure is designed, comprising a first tube and a movable second tube. The first tube has multiple gradually increasing through holes, and the second tube is movably disposed within the first tube. Fluid enters the first tube through the second tube and is transported in segments through the multiple through holes, thereby reducing friction and damage to the target tissue.
This enables segmented fluid delivery, reduces damage to target tissues, improves fluid flow uniformity and effectiveness, and enhances the operational flexibility and safety of the catheter.
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Figure CN121944339A_ABST
Abstract
Description
Fluid control device with dual tubes Technical Field
[0001] This disclosure relates to the biomedical engineering industry, specifically to a fluid control device with a dual-tube body. Background Technology
[0002] Angiography catheters are medical devices commonly used in the medical field, particularly in interventional radiology and endovascular surgery. They are primarily used in interventional procedures such as angiography, aneurysm treatment, and angioplasty to deliver contrast agents or other medical materials into blood vessels or organs, allowing doctors to clearly observe the internal structures of these vessels or organs using imaging techniques such as X-rays.
[0003] With the development of medical technology, especially the continuous progress in interventional radiology and endovascular surgery, higher requirements have been placed on the performance and function of angiography catheters. Although existing angiography catheters can meet clinical needs to a certain extent, they still have some limitations in the diagnosis and treatment of vascular lesions, particularly in the segmental angiography of blood vessels.
[0004] For example, in endovascular treatment of aortic dissection with stent graft implantation, confirming that the catheter is in the true lumen is crucial for surgical success. Currently, the differentiation between the true and false lumen largely relies on experienced physicians with a good feel for the procedure. These physicians repeatedly adjust the position of the angiography catheter and perform angiography to determine the true and false lumen. Currently, when using ordinary catheters for angiography, the catheter only has a few openings at the tip and 3cm from the tip. However, aortic dissection angiography requires identifying a length of approximately 50-80cm between the true and false lumen. Using ordinary angiography catheters to differentiate between the true and false lumen in aortic dissection requires repeated insertion and withdrawal of the guidewire and catheter. In lesions where true and false lumens are difficult to distinguish, this can lead to intimal damage and unclear identification, resulting in serious consequences such as surgical failure and stent placement in the false lumen.
[0005] For example, in complex or uncertain diagnoses: when the initial angiography results are unclear or questionable, multiple angiography sessions may be required to further confirm the diagnosis and assess the details of the lesion.
[0006] For example, monitoring of interventional treatments: After certain interventional treatments, such as stent implantation, angioplasty, or other endovascular treatments, multiple angiography sessions may be required to monitor the treatment effect and detect possible complications in a timely manner.
[0007] In summary, existing catheter systems have significant shortcomings in terms of functional expansion and operational flexibility. There is an urgent need to develop angiography-integrated, easy-to-operate, and patient-friendly catheter systems through technological innovation to improve treatment outcomes and reduce patient trauma and economic burden. Summary of the Invention
[0008] This disclosure is made in view of the above-mentioned state of the prior art, and its purpose is to provide a fluid control device with a dual-tube body that facilitates segmented fluid delivery and reduces damage to target tissues.
[0009] Therefore, this disclosure provides a fluid control device with a dual-tube structure, including a first tube, a second tube in fluid communication with the first tube, a distal end, and a proximal end; the first tube has a plurality of first through holes, the area of which gradually increases along the direction from the proximal end to the distal end; the second tube has an inlet near the proximal end and a first opening near the distal end, which communicate with the lumen of the second tube; at least a portion of the second tube is movably disposed within the lumen of the first tube, fluid enters the lumen of the second tube through the inlet and flows into the lumen of the first tube through the first opening, and the fluid flowing into the lumen of the first tube flows out through the plurality of first through holes.
[0010] In this disclosure, by distributing multiple first through holes on a first tube body and movably arranging at least a portion of a second tube body within the first tube body, the fluid control device can facilitate segmented fluid delivery when the second tube body is moved to allow fluid to flow out from different positions within the first tube body through the multiple first through holes. Furthermore, since the second tube body moves within the first tube body without direct contact with the target tissue, friction on the target tissue is reduced, thereby minimizing damage. Additionally, because the fluid pressure gradually decreases from the proximal end to the distal end, by gradually increasing the area of the multiple first through holes from the proximal end to the distal end, fluid can flow out of the first tube body through larger area first through holes at lower pressure positions, which helps improve the uniformity of fluid flow and thus enhances the fluid's effectiveness.
[0011] Furthermore, in the fluid control device with a dual-tube body disclosed herein, optionally, the plurality of first through holes are arranged in groups, with the distance between two adjacent groups gradually decreasing along the direction from the proximal end to the distal end. In this case, arranging the plurality of first through holes in groups allows fluid to flow out from the plurality of first through holes in each group, reducing the impact of the fluid on the target tissue. Additionally, since the fluid pressure gradually decreases along the direction from the proximal end to the distal end, by making the distance between two adjacent groups gradually decrease along the direction from the proximal end to the distal end, the fluid can flow out of the first tube body through denser groups at locations of lower pressure, which helps to improve the uniformity of fluid flow.
[0012] Additionally, in the fluid control device with a dual-tube body disclosed herein, optionally, the first opening includes a plurality of second through holes located in the wall of the second tube body. In this case, when fluid flows into the cavity of the first tube body through the first opening of the second tube body, the fluid pressure is reduced by allowing the fluid to flow out through the plurality of second through holes to disperse the fluid, thereby reducing the swaying at the distal end of the second tube body caused by excessive fluid pressure.
[0013] Furthermore, in the fluid control device with a dual-tube body disclosed herein, the plurality of second through holes may optionally be distributed circumferentially along the second tube body, or axially and circumferentially. In this case, by distributing the plurality of second through holes circumferentially along the second tube body, fluid can flow out from different directions, reducing the resultant force of the fluid pressure acting on the second tube body, thereby further reducing the swaying at the distal end of the second tube body caused by excessive fluid pressure. Additionally, by distributing the plurality of second through holes axially and circumferentially along the second tube body, the effectiveness of the second through holes in controlling the swaying of the second tube body can be improved.
[0014] Furthermore, in the fluid control device with a dual-tube body disclosed herein, optionally, the distance between the first through-hole and the end of the first tube near the proximal end is greater than or equal to a preset distance. In this case, during the process of the first tube body entering the target tissue, since the fluid in the target tissue has pressure and flows out of the target tissue through the first tube body under the action of pressure, by making the distance between the first through-hole and the end of the first tube near the proximal end greater than or equal to the preset distance, the amount of fluid flowing out of the target tissue can be reduced.
[0015] Furthermore, in the fluid control device with dual tubes disclosed herein, optionally, the distal end of the first tube and / or the distal end of the second tube is bent in a direction away from the axis of the fluid control device. In this case, by bending the distal end of the first tube or the distal end of the second tube, it is easier for the fluid control device to enter the curved portion of the target tissue. Additionally, by bending the distal ends of the first and second tubes, the distal end of the fluid control device can rotate about multiple different axes, thereby further facilitating the fluid control device's entry into the curved portion of the target tissue.
[0016] Furthermore, in the fluid control device with dual tubes disclosed herein, optionally, the elasticity of the first tube and the elasticity of the second tube gradually increase along the direction from the proximal end to the distal end. This reduces damage to the target tissue and facilitates the passage of the first and second tubes through the curved portions of the target tissue.
[0017] Furthermore, in the fluid control device with two tubes disclosed herein, optionally, the length of the second tube is greater than the length of the first tube. This facilitates the second tube extending beyond the first tube.
[0018] Additionally, in the fluid control device with a dual-tube configuration disclosed herein, the second tube may optionally include a protrusion disposed on its outer surface, the protrusion being closer to the proximal end than the first opening. In this case, when fluid flows into the lumen of the first tube through the first opening, the protrusion on the outer surface of the second tube, being closer to the proximal end than the first opening, helps to seal the lumen of the first tube, reducing backflow of fluid within the lumen of the first tube.
[0019] Additionally, in the fluid control device with dual tubes disclosed herein, a marking portion may optionally be included, which is embedded in the first tube and / or the second tube. In this case, it is convenient to obtain the position of the fluid control device in the target tissue. Since the stiffness of the marking portion is generally greater than the stiffness of the first tube or the second tube, by embedding the marking portion in the first tube or the second tube, the risk of the marking portion damaging the target tissue can be reduced. Furthermore, by embedding the marking portion in both the first and second tubes, that is, when the marking portion is simultaneously embedded in both the first and second tubes, the relative position of the first and second tubes can be obtained through the marking portion.
[0020] According to this disclosure, a fluid control device with a dual-tube structure is provided that facilitates segmented fluid delivery and reduces damage to target tissues. Attached Figure Description
[0021] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings.
[0022] Figure 1 is a diagram illustrating an application scenario of the fluid control device involved in the example of this disclosure.
[0023] Figure 2 is a schematic diagram showing the mating of the first tube and the second tube in the example of this disclosure.
[0024] Figure 3A is a structural schematic diagram illustrating a first embodiment of the first tube body involved in the present disclosure.
[0025] Figure 3B is a structural schematic diagram illustrating a second embodiment of the first tube body involved in the example of this disclosure.
[0026] Figure 3C is a structural schematic diagram illustrating a third embodiment of the first tube body involved in the present disclosure.
[0027] Figure 4A is a structural schematic diagram illustrating a first embodiment of the second tube body according to an example of this disclosure.
[0028] Figure 4B is a structural schematic diagram illustrating a second embodiment of the second tube body involved in the example of this disclosure.
[0029] Figure 5 is a schematic diagram showing the second tube extending out of the first tube in the example of this disclosure.
[0030] Figure 6A is a schematic diagram showing the bending of the distal ends of the first tube and the second tube as described in this disclosure example.
[0031] Figure 6B is a schematic diagram showing the curved portion of the first and second tubes involved in the present disclosure entering the target tissue.
[0032] Figure 7A is a schematic diagram showing the first embodiment of the embedding position of the marking portion involved in the example of this disclosure.
[0033] Figure 7B is a schematic diagram showing the second embodiment of the embedding position of the marking portion involved in the example of this disclosure.
[0034] Explanation of reference numerals in the attached figures:
[0035] 1…fluid control device, 11…first tube body, 111…first through hole, 12…second tube body, 121…first opening, 1211…second through hole, 1212…pipe opening, 122…protrusion, 13…guide wire, 14…Y-type connecting valve, 15…stress relief tube, 16…marking part, 2…target tissue. Detailed Implementation
[0036] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures.
[0037] It should be noted that the terms "comprising" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device that includes or has a series of steps or units, are not necessarily limited to those steps or units that are explicitly listed, but may include or have other steps or units that are not explicitly listed or that are inherent to such processes, methods, products, or devices.
[0038] It should be noted that in this article, relative position and direction terms such as "above", "facing upward", "below", "facing downward", "up and down direction", "left side", "facing left side", "left side", "facing left side", "right side", "facing right side", "right side", "facing right side", "left and right direction", "front", "facing forward", "back", "facing backward", and "front and back direction" are used with reference to the usual operating posture and should not be considered as restrictive.
[0039] First, let me introduce the relevant terminology used in this disclosure.
[0040] "The effect of fluid" can refer to the degree to which the fluid exerts its effect after a certain amount of fluid is introduced. For example, if the blood vessels become clearly visible after a certain amount of contrast agent is introduced, the fluid effect can be considered good. Conversely, if the contrast agent concentration varies at different locations within the blood vessel, resulting in some parts of the vessel being clear while others are blurry, the fluid effect can be considered poor.
[0041] "The uniformity of fluid flow rate" can refer to the degree of equality of the flow rate of fluid flowing out from each first orifice or each second orifice within the same time period. For example, if the flow rate of fluid flowing out from each first orifice is equal or similar within the same time period, the uniformity of fluid flow rate can be considered high.
[0042] The inventors discovered that during angiography or thrombolysis, frequent catheter manipulation is often required. For example, if residual thrombus is found after thrombolysis, a different catheter size needs to be used to reduce waste of thrombolytic drugs. Dragging the catheter can cause vascular damage and increase patient discomfort. Therefore, the inventors proposed a dual-tube fluid control device that facilitates segmented fluid delivery and reduces damage to target tissues, thereby alleviating patient discomfort. Segmented fluid delivery refers to delivering fluid to and applying it to different locations within the target tissue.
[0043] In addition, the inventors discovered that the flow rate of the fluid flowing out from different through holes of the fluid control device was different, resulting in poor fluid effect. After research, it was found that this was due to the pressure difference of the fluid at different positions of the fluid control device. Therefore, the inventors proposed a fluid control device with a dual tube body to improve the uniformity of fluid flow rate, thereby improving the fluid effect.
[0044] In some examples, the fluid control device with a dual-tube body disclosed herein may also be referred to as a fluid control device, control device, liquid outlet device, fluid control conduit with a dual-tube body, dual-tube conduit, or dual-lumen conduit.
[0045] In some examples, the target tissue can be a lumen. For example, the target tissue can be a vascular lumen. In some examples, the target tissue can include lesions or suspected lesions within a vascular lumen. For example, the target tissue can include a narrowed segment of a blood vessel. However, the lumen involved in the examples of this disclosure may not be limited to vascular lumens, but may also be lumens related to a living organism. For example, the lumen of the esophagus, intestine, or ureter. In some examples, the lumen may also refer to the lumen of non-biological tissue.
[0046] In some examples, "fluid" can refer to a flowable substance delivered by an operator to the target tissue via a fluid control device. For example, when the fluid control device is an angiography catheter, the fluid can refer to a contrast agent. As another example, when the fluid control device is a thrombolytic catheter, the fluid can refer to a thrombolytic drug. In some examples, "fluid" can also refer to a flowable substance within the target tissue. For example, when the target tissue is a blood vessel, the fluid can refer to blood.
[0047] For ease of description, some examples below use blood vessels as the target tissue, and correspondingly, blood as the fluid within the target tissue. It should be noted that this does not constitute a limitation of this disclosure, and unless there is a contradiction, the relevant descriptions also apply to fluids within the target tissue.
[0048] The following detailed description, in conjunction with the accompanying drawings, describes a fluid control device (hereinafter referred to as "fluid control device") with a dual-tube body, as described in this disclosure.
[0049] Figure 1 is a diagram illustrating an application scenario of the fluid control device 1 involved in the example of this disclosure.
[0050] In some examples, the fluid control device 1 can be configured to deliver fluid. In some examples, referring to Figure 1, the fluid control device 1 can extend into the target tissue 2. In some examples, the fluid control device 1 can deliver fluid to the target tissue 2. In some examples, the fluid control device 1 can be flushed with heparinized saline.
[0051] In some examples, the fluid control device 1 may include a distal end and a proximal end. In some examples, the distal end may be the end of the fluid control device 1 furthest from the operator (e.g., a doctor) during operation, and the proximal end may be the end of the fluid control device 1 closest to the operator during operation. In some examples, fluid may flow in from the proximal end of the fluid control device 1. In some examples, fluid may flow out from the distal end of the fluid control device 1. Thus, fluid can be delivered to the target tissue 2 via the fluid control device 1.
[0052] Figure 2 is a schematic diagram showing the cooperation between the first tube 11 and the second tube 12 according to the example of this disclosure. It should be noted that, for ease of description, Figure 2 only schematically illustrates the first embodiment of the first tube 11, and the related description is equally applicable to other embodiments of the first tube 11.
[0053] In some examples, the fluid control device 1 may include a first tube 11 and a second tube 12 (see Figure 2). In some examples, the first tube 11 may be in fluid communication with the second tube 12. Fluid communication may mean that the first tube 11 and the second tube 12 are connected and fluid can flow between the first tube 11 and the second tube 12.
[0054] In some examples, referring to Figure 2, the first tube 11 may include a first through hole 111. In some examples, the second tube 12 may include an infusion port and a first opening 121. In some examples, the first opening 121 may include a second through hole 1211.
[0055] In some examples, fluid can enter the lumen of the second tube 12 through the inlet and flow into the lumen of the first tube 11 through the first opening 121. In some examples, the fluid flowing into the lumen of the first tube 11 can flow out through a plurality of first through holes 111. In some examples, the second tube 12 can be disposed within the first tube 11. In some examples, at least a portion of the second tube 12 can be movably disposed within the lumen of the first tube 11.
[0056] In this disclosure, by distributing a plurality of first through holes 111 on a first tube 11 and movably arranging at least a portion of a second tube 12 within the first tube 11, the fluid control device 1 can facilitate segmented fluid delivery when the second tube 12 is moved to allow fluid to flow out from different positions of the first tube 11 through the plurality of first through holes 111. Furthermore, since the second tube 12 moves within the first tube 11 without direct contact with the target tissue 2, friction on the target tissue 2 is reduced, thereby minimizing damage to the target tissue 2. Additionally, by movably arranging at least a portion of the second tube 12 within the lumen of the first tube 11, it is possible to apply fluid to different positions of the target tissue 2 without moving the first tube 11.
[0057] In some examples, see Figure 2, the diameter of the first tube 11 may be larger than the diameter of the second tube 12.
[0058] In some examples, the diameter of the distal end of the first tube 11 can be larger than the diameter of the second tube 12. This allows the second tube 12 to extend out of the first tube 11 through the distal end of the first tube 11.
[0059] In some examples, referring to Figure 2, the inner diameter of the first tube 11 can be larger than the outer diameter of the second tube 12. This allows the second tube 12 to move within the first tube 11.
[0060] Figure 3A is a schematic diagram showing the structure of a first embodiment of the first tube 11 according to the present disclosure. Figure 3B is a schematic diagram showing the structure of a second embodiment of the first tube 11 according to the present disclosure. Figure 3C is a schematic diagram showing the structure of a third embodiment of the first tube 11 according to the present disclosure.
[0061] As described above, the fluid control device 1 may include a first tube body 11.
[0062] In some examples, the elasticity of the first tube 11 can gradually increase from the proximal end to the distal end. This reduces damage to the target tissue 2 and facilitates the passage of the first tube 11 through the curved portion of the target tissue 2. Furthermore, it facilitates the passage of the distal portion of the first tube 11 through the curved portion of the target tissue 2 and reduces the risk of lumen collapse in the proximal portion of the first tube 11.
[0063] In some examples, referring to Figures 3A, 3B, or 3C, the first tube 11 may be cylindrical in shape. In some examples, the tube body of the first tube 11 may be cylindrical in shape.
[0064] In some examples, referring to Figures 3A, 3B, or 3C, the distal end of the first tube 11 may be tapered. That is, the distal end of the first tube 11 may taper towards the axis of the first tube 11. This reduces damage to the target tissue 2.
[0065] In some examples, the distal portion of the first tube 11 can be straight or curved. That is, the distal portion can be generally straight or curved. In this case, a first tube 11 with a straight distal portion facilitates the delivery of the fluid control device 1 into the target tissue 2. Conversely, a first tube 11 with a curved distal portion facilitates the entry of the fluid control device 1 into the curved portion of the target tissue 2. In some examples, the curve can include a J-shape or a pigtail shape. It should be noted that the shape of the distal portion of the first tube 11 can also be other shapes that facilitate intervention in the blood vessel.
[0066] In some examples, the portion of the first tube 11 near its distal end may form an angle with the axis of the first tube 11. In some examples, the angle may be from 10 degrees to 70 degrees. For example, the angle may be 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, and 70 degrees. Preferably, the angle may be from 20 degrees to 60 degrees.
[0067] In some examples, the first tube 11 may be composed of at least one of a polymer, a braided mesh, and a spring. For example, the first tube 11 may consist of only one layer of polymer. As another example, the first tube 11 may be welded together from an inner layer of polymer forming the lumen of the first tube 11, a stainless steel spring disposed outside the inner layer of polymer, and an outer layer of polymer covering the outside of the stainless steel spring. In some examples, the inner layer of polymer may be a PTFE (Polytetrafluoroethylene) membrane.
[0068] As described above, the first tube 11 may have a first through hole 111. In some examples, the first through hole 111 may be configured to allow fluid to pass through. In some examples, the first through hole 111 may be configured to allow fluid in the first tube 11 to pass through so that fluid flows out of the first tube 11. In some examples, the number of first through holes 111 may be multiple (see Figures 3A, 3B, or 3C).
[0069] In some examples, referring to Figures 3B or 3C, the area of the plurality of first through holes 111 can gradually increase in the direction from the proximal end to the distal end. That is, in the direction from the proximal end to the distal end, the total area of the first through holes 111 within a region of the same length of the first tube body 11 gradually increases. In this case, since the fluid pressure gradually decreases in the direction from the proximal end to the distal end, by making the area of the plurality of first through holes 111 gradually increase in the direction from the proximal end to the distal end, the fluid can flow out of the first tube body 11 through the larger area of the first through holes 111 at the position of lower pressure, which helps to improve the uniformity of the fluid flow and thus improve the effect of the fluid.
[0070] In some examples, the first through-hole 111 can also be configured to allow fluid outside the first tube 11 to flow into the lumen of the first tube 11. Taking blood as an example, blood can flow into the lumen of the first tube 11 through the first through-hole 111. In some examples, blood can flow from the distal end to the proximal end of the first tube 11, thereby facilitating blood collection or blood pressure measurement by the operator.
[0071] In some examples, referring to Figures 3A, 3B, or 3C, the first through hole 111 may be located on the wall of the first tube 11. In some examples, the first through hole 111 may be located near the distal end of the first tube 11.
[0072] In some examples, referring to Figure 3C, the number of first through holes 111 can gradually increase along the direction from the proximal end to the distal end. In this case, by increasing the number of first through holes 111 to increase the area of the first through holes 111, the fluid can be dispersed to flow out through multiple first through holes 111, which helps to improve the atomization effect of the fluid. In addition, it is convenient to make the area of multiple first through holes 111 gradually increase along the direction from the proximal end to the distal end.
[0073] In some examples, the first through hole 111 can be circular, elliptical, or rectangular.
[0074] In some examples, referring to Figure 3B, the diameter of the first through hole 111 can gradually increase along the direction from the proximal end to the distal end. In this case, increasing the diameter of the first through hole 111 increases its area, which facilitates the processing of the first tube body 11.
[0075] It should be noted that, while maintaining the area of the plurality of first through holes 111 gradually increasing in the direction from the proximal end to the distal end, the number and diameter of the first through holes 111 can be arbitrarily varied. For example, the number of first through holes 111 can gradually increase in the direction from the proximal end to the distal end and the diameter of the first through holes 111 can gradually decrease in the direction from the proximal end to the distal end. Or, for example, the number of first through holes 111 can gradually decrease in the direction from the proximal end to the distal end and the diameter of the first through holes 111 can gradually increase in the direction from the proximal end to the distal end. However, this does not imply a limitation of this disclosure.
[0076] In some examples, the diameter of the first through hole 111 can be from 0.1 mm to 3 mm. For example, the diameter of the first through hole 111 can be 0.1 mm, 0.2 mm, 0.3 mm, 0.5 mm, 0.7 mm, 1 mm, 1.5 mm, 2 mm and / or 3 mm. Preferably, the diameter of the first through hole 111 can be from 0.5 mm to 1.2 mm.
[0077] As described above, the diameter of the first through hole 111 can gradually increase in the direction from the proximal end to the distal end. In some examples, the diameter of the first through hole 111 can gradually increase from 0.5 mm to 1.2 mm in the direction from the proximal end to the distal end. For example, when there are 8 first through holes 111, the diameters of the first through holes 111 in the direction from the proximal end to the distal end can be successively 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, and 1.2 mm.
[0078] In some examples, the density of the first through holes 111 may gradually increase along the direction from the proximal end to the distal end (see Figure 3C). In some examples, the density of the first through holes 111 may refer to the number of first through holes 111 per 1 cm of the first tube body 11. In some examples, the density of the first through holes 111 may be from 1 to 15 per cm. For example, the density of the first through holes 111 may be 1, 2, 3, 5, 7, 10, 12, and / or 15 per cm. Preferably, the density of the first through holes 111 may be from 3 to 12 per cm.
[0079] In some examples, referring to Figure 3B, a plurality of first through holes 111 can be distributed along the axial direction of the first tube 11. In this case, by distributing a plurality of first through holes 111 along the axial direction of the first tube 11, fluid can be facilitated to flow out from multiple locations along the axial direction of the first tube 11 without moving the first tube 11, thereby further reducing damage to the target tissue 2.
[0080] In some examples, referring to Figure 3A, the plurality of first through holes 111 may be arranged in a spiral shape along the axial direction of the first tube body 11. In this case, by arranging the plurality of first through holes 111 in a spiral shape along the axial direction of the first tube body 11, the orientation of the plurality of first through holes 111 can be different, thereby reducing the impact of fluid flowing out of the plurality of first through holes 111 on the same location of the target tissue 2.
[0081] In some examples, referring to Figure 3B, the plurality of first through holes 111 can be arranged in a straight line along the axial direction of the first tube 11. In this case, by arranging the plurality of first through holes 111 in a straight line along the axial direction of the first tube 11, fluid can flow out from the same side of the first tube 11 through the plurality of first through holes 111, acting more concentratedly on one side of the target tissue 2, thereby improving the effect of the fluid. For example, when the lesion on one side of the target tissue 2 is more severe, by orienting the plurality of first through holes 111 on the same side toward the lesion, fluid can flow out from the first through holes 111 and act more directly on the lesion, thereby improving the effect of the fluid.
[0082] In some examples, the arrangement of the plurality of first through holes 111 along the axial direction of the first tube body 11 may include both spiral and straight arrangements. In some examples, the plurality of first through holes 111 may also be arranged in other forms along the axial direction of the first tube body 11.
[0083] In some examples, referring to Figures 3A, 3B, or 3C, a plurality of first through holes 111 may be distributed along the circumference of the first tube 11. In this case, by distributing a plurality of first through holes 111 along the circumference of the first tube 11, fluid can flow out from multiple locations in the circumference of the first tube 11 without rotating the first tube 11, thereby further reducing damage to the target tissue 2.
[0084] In some examples, referring to Figure 3A, the multiple first through holes 111 can be arranged in groups. In this case, arranging the multiple first through holes 111 in groups, with fluid flowing out from the multiple first through holes 111 in each group, can reduce the impact of the fluid on the target tissue 2. For example, by grouping multiple first through holes 111 with smaller diameters, when the fluid flows out from the through hole group, the fluid will flow out in an atomized form due to the smaller diameter of the multiple first through holes 111, thereby reducing the impact of the fluid on the target tissue 2.
[0085] In some examples, the number of first through holes 111 in each group can be from 3 to 15. For example, the number of first through holes 111 in a group is 3, 4, 5, 7, 10, and 15. Preferably, the number of first through holes 111 in a group can be from 5 to 12. In some examples, the number of first through holes 111 in each group can be the same or different.
[0086] In some examples, the first through holes 111 in each group can be arranged in a square, hexagonal, circular, annular or star shape.
[0087] In some examples, the distance between two adjacent groups gradually decreases from the proximal end to the distal end. In this case, since the fluid pressure gradually decreases from the proximal end to the distal end, by making the distance between two adjacent groups gradually decrease from the proximal end to the distal end, the fluid can flow out of the first tube 11 through denser groups at locations with lower pressure, which helps to improve the uniformity of the fluid flow.
[0088] Additionally, in some examples, see Figure 3A, the distance between two adjacent groups can be equal.
[0089] In some examples, the distance between two adjacent groups can be from 1 mm to 30 mm. For example, the distance between two adjacent groups can be 1 mm, 3 mm, 5 mm, 10 mm, 15 mm, 20 mm, and 30 mm. Preferably, the distance between two adjacent groups can be from 5 mm to 20 mm.
[0090] In some examples, the distance between the first through-hole 111 and the proximal end of the first tube 11 is greater than or equal to a preset distance. In this case, during the process of the first tube 11 entering the target tissue 2, since the fluid in the target tissue 2 is under pressure and flows out of the target tissue 2 through the first tube 11 under the action of pressure, by making the distance between the first through-hole 111 and the proximal end of the first tube 11 greater than or equal to the preset distance, the amount of fluid flowing out of the target tissue 2 can be reduced. For example, when the target tissue 2 is a blood vessel, under the action of blood pressure, blood enters the lumen of the first tube 11 through the first through-hole 111 and flows proximally. If a portion of the first through-hole 111 has not yet entered the blood vessel, blood may flow out of the patient's body through this portion of the first through-hole 111, which would cause unnecessary blood loss.
[0091] In some examples, the distance between the first through hole 111 and the end of the first tube 11 near the proximal end can refer to the distance between the first through hole 111 closest to the proximal end and the end of the first tube 11 near the proximal end. In some examples, the preset distance can be 50 centimeters.
[0092] In some examples, the length of the perforated area of the first tube 11 can be from 1 cm to 60 cm. For example, it can be 1 cm, 3 cm, 5 cm, 10 cm, 15 cm, 20 cm, 30 cm, 40 cm, 50 cm, and 60 cm. Preferably, the length of the perforated area can be from 5 cm to 50 cm. In some examples, the length of the perforated area of the first tube 11 can refer to the distance between the first through hole 111 closest to the proximal end and the first through hole 111 closest to the distal end.
[0093] In some examples, the shape of the first through hole 111 can be square, hexagonal, circular or elliptical.
[0094] Figure 4A is a schematic diagram showing the structure of a first embodiment of the second tube 12 according to the present disclosure. Figure 4B is a schematic diagram showing the structure of a second embodiment of the second tube 12 according to the present disclosure.
[0095] As described above, the fluid control device 1 may include a second tube 12.
[0096] In some examples, the elasticity of the second tube 12 can gradually increase from the proximal end to the distal end. This reduces damage to the target tissue 2 and facilitates the passage of the second tube 12 through the curved portion of the target tissue 2. Additionally, it facilitates the passage of the portion of the second tube 12 closer to the distal end through the curved portion of the target tissue 2.
[0097] In some examples, the second tube 12 may be cylindrical in shape.
[0098] In some examples, referring to Figure 4, the distal end of the second tube 12 may be tapered. That is, the distal end of the second tube 12 may taper towards the axis of the second tube 12. This reduces damage to the target tissue 2.
[0099] In some examples, referring to Figures 4A or 4B, the distal portion of the second tube 12 can be straight or curved. This improves the applicability of the fluid control device 1. In some examples, the curve can be J-shaped or pigtail-shaped. It should be noted that the shape of the distal portion of the second tube 12 can also be other shapes that facilitate intervention in blood vessels.
[0100] In some examples, the portion of the second tube 12 near its distal end may form an angle with the axis of the second tube 12, and this angle may be between 10 degrees and 70 degrees. For example, the angle may be 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, and 70 degrees. Preferably, the angle may be between 20 degrees and 60 degrees.
[0101] In some examples, the second tube 12 may be composed of at least one of a polymer, a braided mesh, and a spring. For example, the second tube 12 may consist of only one layer of polymer. As another example, the second tube 12 may be welded together from an inner layer of polymer forming the lumen of the second tube 12, a stainless steel spring disposed outside the inner layer of polymer, and an outer layer of polymer covering the outside of the stainless steel spring. The inner layer of polymer may be a PTFE (Polytetrafluoroethylene) membrane.
[0102] As described above, the second tube 12 may have an inlet port. In some examples, the inlet port may communicate with the lumen of the second tube 12. In some examples, the inlet port may be configured to allow fluid to flow into the fluid control device 1. In some examples, the inlet port may be configured to allow fluid to pass through so that fluid flows into the lumen of the second tube 12; in other words, fluid may enter the lumen of the second tube 12 via the inlet port.
[0103] In some examples, the inlet can be located near the proximal end. This facilitates the introduction of fluid into the second tube 12.
[0104] As described above, the second tube 12 may include a first opening 121. In some examples, the first opening 121 may be configured to allow fluid to pass through. In some examples, the first opening 121 may be configured to allow fluid to flow from the lumen of the second tube 12 into the lumen of the first tube 11; in other words, fluid can flow into the lumen of the first tube 11 through the first opening 121.
[0105] In some examples, the first opening 121 can be located near the distal end. This allows fluid in the second tube 12 to flow into the first tube 11.
[0106] As described above, the first opening 121 may include a second through hole 1211. In some examples, the second through hole 1211 may be located in the wall of the second tube 12. In some examples, the second through hole 1211 may be located near the distal end of the second tube 12.
[0107] In some examples, see Figure 4A or Figure 4B, there may be multiple second through holes 1211. In this case, when fluid flows into the cavity of the first tube 11 through the first opening 121 of the second tube 12, the fluid pressure is reduced by dispersing the fluid through multiple second through holes 1211, thereby reducing the sloshing at the distal end of the second tube 12 caused by excessive fluid pressure.
[0108] In some examples, the number of second through holes 1211 can be from 1 to 15. For example, the number of second through holes 1211 can be 1, 2, 3, 5, 7, 10, and 15. Preferably, the number of second through holes 1211 can be from 1 to 10.
[0109] In some examples, referring back to Figure 2, multiple second through holes 1211 may be distributed along the axial direction of the second tube body 12.
[0110] In some examples, referring to Figure 2, multiple second through holes 1211 are distributed circumferentially along the second tube body 12. In this case, by distributing multiple second through holes 1211 circumferentially along the second tube body 12, fluid can flow out from different directions, reducing the resultant force of the fluid pressure acting on the second tube body 12, thereby further reducing the swaying at the distal end of the second tube body 12 caused by excessive fluid pressure.
[0111] In some examples, multiple second through holes 1211 may be distributed along the axial and circumferential directions of the second tube body 12. In this case, by distributing multiple second through holes 1211 along the axial and circumferential directions of the second tube body 12, the effectiveness of the second through holes 1211 in controlling the sway of the second tube body 12 can be improved.
[0112] In some examples, referring to Figure 4A or Figure 4B, a plurality of second through holes 1211 may be uniformly distributed in the second tube body 12. In some examples, uniform distribution may mean that the plurality of second through holes 1211 are equidistant in both the axial and circumferential directions. That is, the plurality of second through holes 1211 may be distributed at equal intervals along the axial and / or circumferential directions of the second tube body 12. This allows for further swaying of the distal end of the second tube body 12. In some examples, the plurality of second through holes 1211 may be arranged in an array.
[0113] In some examples, the length of the perforated area of the second tube 12 can be from 1 mm to 30 mm. For example, it can be 1 mm, 3 mm, 5 mm, 7 mm, 10 mm, 15 mm, 20 mm, 25 mm, and 30 mm. Preferably, the length of the perforated area can be from 5 mm to 20 mm. In some examples, the length of the perforated area of the second tube 12 can refer to the distance between the second through hole 1211 closest to the proximal end and the second through hole 1211 closest to the distal end.
[0114] In some examples, the diameter of the second through hole 1211 can be from 0.1 mm to 2 mm. For example, the diameter of the second through hole 1211 can be 0.1 mm, 0.2 mm, 0.3 mm, 0.5 mm, 0.7 mm, 1 mm, 1.3 mm, 1.5 mm, and 2 mm. Preferably, the diameter of the second through hole 1211 can be from 0.5 mm to 1 mm.
[0115] In some examples, the shape of the second through hole 1211 can be square, hexagonal, circular, elliptical, or star-shaped. Preferably, the shape of the second through hole 1211 can be square, circular, or elliptical.
[0116] In some examples, referring to Figure 4A or Figure 4B, the first opening 121 may include a port 1212. In some examples, the port 1212 may be configured to allow the guide wire 13 of the fluid control device 1 to pass through. In some examples, the fluid control device 1 may include the guide wire 13. In some examples, the guide wire 13 may be configured to guide the first tube body 11 and the second tube body 12 into the target tissue 2.
[0117] In some examples, the nozzle 1212 may be located at the distal end of the second tube 12 (see Figure 4A or Figure 4B). In some examples, the center of the nozzle 1212 may be located on the axis of the second tube 12. In some examples, the nozzle 1212 may be circular in shape.
[0118] In some examples, see Figure 4A or Figure 4B, the first opening 121 may include a second through hole 1211 and a nozzle 1212.
[0119] In some examples, referring to Figure 4A or Figure 4B, the second tube 12 may include a protrusion 122. In some examples, the protrusion 122 may be configured to block backflow of fluid. In some examples, the protrusion 122 may be configured to block backflow of fluid from the lumen of the first tube 11 outside the second tube 12.
[0120] In some examples, the protrusion 122 may be provided on the outer surface of the second tube 12. In some examples, the protrusion 122 may be located closer to the proximal end than the first opening 121. In this case, when fluid flows into the lumen of the first tube 11 through the first opening 121, providing the protrusion 122 on the outer surface of the second tube 12 closer to the proximal end than the first opening 121 helps to close the lumen of the first tube 11 and reduce the backflow of fluid in the lumen of the first tube 11. In addition, by reducing the backflow of fluid in the lumen of the first tube 11, the fluid utilization rate can be improved.
[0121] In some examples, the protrusion 122 may be located between the inner surface of the first tube 11 and the outer surface of the second tube 12 (see Figure 2). In some examples, the protrusion 122 may be annular in shape.
[0122] In some examples, the number of protrusions 122 can be at least one. For example, there can be one, two, three, or four.
[0123] In some examples, the inner contour of the protrusion 122 may be the same as the outer contour of the second tube 12. In some examples, the inner diameter of the protrusion 122 may be equal to or slightly smaller than the outer diameter of the second tube 12. In this case, by making the protrusion 122 fit tightly against the outer surface of the second tube 12, it is possible to help block backflow of fluid.
[0124] In some examples, see Figure 4A or Figure 4B, the outer diameter of the protrusion 122 may be slightly larger than the outer diameter of the second tube 12.
[0125] In some examples, referring back to Figure 2, the outer edge and inner edge of protrusion 122 can respectively conform to the inner surface of the first tube 11 and the outer surface of the second tube 12. This helps to prevent backflow of fluid.
[0126] In some examples, the protrusion 122 and the wall of the second tube 12 can be separate. In some examples, the protrusion 122 can be fixed to the second tube 12. For example, the protrusion 122 can be bonded to the second tube 12.
[0127] In some examples, the protrusion 122 can be integrally formed with the wall of the second tube 12.
[0128] In some examples, there may be multiple protrusions 122. In some examples, multiple protrusions 122 may be arranged on the outer surface of the second tube 12 in a direction from proximal to distal end. This helps to block backflow of fluid.
[0129] In some examples, the protrusion 122 can be an elastomer. That is, the protrusion 122 can be made of an elastic material. For example, the protrusion 122 can be made of at least one of natural rubber, thermoplastic elastomer, polydimethylsiloxane, and bio-based polyester elastomer.
[0130] In some examples, taking blood vessels as an example, during the process of extending the first tube 11 from the outside into the blood vessel, blood may flow out through the first through-hole 111 on the part of the first tube 11 that is not inserted into the body under the influence of blood pressure. In this case, a second tube 12 with a protrusion 122 can be inserted into the first tube 11, and the protrusion 122 can be used to block the blood flow. This reduces blood loss.
[0131] Figure 5 is a schematic diagram showing the second tube 12 extending out of the first tube 11 according to the example of this disclosure.
[0132] In some examples, the second tube 12 may extend beyond the first tube 11 (see Figure 5). In some examples, the distal portion of the second tube 12 may extend beyond the distal end of the first tube 11. In some examples, the stiffness of the second tube 12 may be less than that of the first tube 11. In this case, by extending the less stiff second tube 12 from the first tube 11, it is easier for the fluid control device 1 to pass through the curved portion of the target tissue 2 and to reduce damage to the target tissue 2 caused by the fluid control device 1.
[0133] As described above, the second through-hole 1211 can be located on the wall of the second tube 12. In some examples, when the second tube 12 extends out of the first tube 11, fluid can flow out of the second tube 12 through the second through-hole 1211 and act on the target tissue 2. In this case, taking the target tissue 2 as a blood vessel as an example, since the second through-hole 1211 is located on the wall of the second tube 12, that is, the second through-hole 1211 faces the blood vessel wall, compared with flowing out from the opening 1212 of the second tube 12, the fluid flowing out through the second through-hole 1211 can act more directly on the blood vessel wall, reducing the risk of the fluid being washed away by blood flow and improving the effect of the fluid.
[0134] As described above, the stiffness of the first tube 11 can be greater than that of the second tube 12. In this case, when fluid is injected into the second tube 12, the first tube 11 can provide support for the second tube 12, thereby reducing the risk of the second tube 12 swaying under the pressure of the fluid and facilitating the operation of the second tube 12. In addition, it can reduce the risk of the fluid control device 1 deforming and collapsing under pressure.
[0135] In some examples, the length of the second tube 12 can be greater than the length of the first tube 11. This allows the second tube 12 to extend beyond the first tube 11. In some examples, the length of the second tube 12 can be 5 to 30 centimeters longer than the length of the first tube 11. For example, it can be 5, 7, 10, 15, 20, or 30 centimeters longer. Preferably, the length of the second tube 12 can be 10 to 20 centimeters longer than the length of the first tube 11.
[0136] In some examples, referring to Figure 2 or Figure 5, the first tube 11 and the second tube 12 can be arranged coaxially. That is, the axis of the first tube 11 can coincide with the axis of the second tube 12. This allows the second tube 12 to extend out of the first tube 11.
[0137] Figure 6A is a schematic diagram showing the distal ends of the first tube 11 and the second tube 12 of the present disclosure bent. Figure 6B is a schematic diagram showing the bent portions of the first tube 11 and the second tube 12 of the present disclosure entering the target tissue 2.
[0138] The inventors discovered that when accessing complex blood vessel branches, it is necessary to select and replace catheters with suitable distal shapes to facilitate passage through the complex bends of the vessel, which complicates the surgical procedure and may damage the vessel. Therefore, the inventors improved the structure of the fluid control device 1 to facilitate superselection of blood vessels.
[0139] In some examples, referring to Figures 6A or 6B, the distal end of the first tube 11 or the distal end of the second tube 12 is bent in a direction away from the axis of the fluid control device 1. In this case, by bending the distal end of the first tube 11 or the distal end of the second tube 12, it is possible to facilitate the fluid control device 1 to enter the bent portion of the target tissue 2.
[0140] In some examples, referring to Figures 6A or 6B, the distal ends of the first tube 11 and the second tube 12 are bent in a direction away from the axis of the fluid control device 1. In this case, by bending the distal ends of the first tube 11 and the second tube 12, the distal end of the fluid control device 1 can be rotated about multiple different axes, thereby further facilitating the fluid control device 1 to enter the bent portion of the target tissue 2, for example, when the target tissue 2 is a blood vessel, it is easier to superselect blood vessels.
[0141] In some examples, referring back to Figure 2, the fluid control device 1 may include a Y-connector valve 14. In some examples, the Y-connector valve 14 may be connected to the proximal end of the first tube 11. In some examples, the second tube 12 may be connected to the first tube 11 via the Y-connector valve 14.
[0142] In some examples, the fluid control device 1 may include a stress-relieving tube 15. In some examples, one end of the stress-relieving tube 15 may be connected to a Y-type connecting valve 14, and the other end of the stress-relieving tube 15 may be connected to the proximal end of the first tube body 11. This reduces the risk of the first tube body 11 breaking at the connection point with the Y-type connecting valve 14.
[0143] In some examples, referring back to FIG5, the fluid control device 1 may include a marking section 16. In some examples, the marking section 16 may be configured to mark the position of the fluid control device 1. This facilitates obtaining the position of the fluid control device 1 in the target tissue 2. In some examples, the marking section 16 may be configured to display the positions of the first tube 11 and the second tube 12 in the target tissue 2.
[0144] In some examples, the marking portion 16 may be embedded in the first tube 11 and / or the second tube 12. For example, the marking portion 16 may be welded to the inside of the tube wall of the first tube 11 and / or the second tube 12. In this case, since the rigidity of the marking portion 16 is generally greater than the rigidity of the first tube 11 or the second tube 12, the risk of the marking portion 16 damaging the target tissue 2 can be reduced by embedding the marking portion 16 in the first tube 11 or the second tube 12.
[0145] Furthermore, by embedding the marking portion 16 in both the first tube 11 and the second tube 12, the relative positions of the first tube 11 and the second tube 12 can be obtained through the marking portion 16. For example, when the second tube 12 extends beyond the first tube 11, the position of the portion of the second tube 12 extending beyond the first tube 11 can be obtained through the marking portion 16, thereby facilitating the operation of the second tube 12.
[0146] Figure 7A is a schematic diagram showing the first embodiment of the embedding position of the marking portion 16 according to the example of this disclosure. Figure 7B is a schematic diagram showing the second embodiment of the embedding position of the marking portion 16 according to the example of this disclosure.
[0147] In some examples, the marking portion 16 may be enclosed by the wall of the second tube 12 (see Figure 7A). In some examples, the marking portion 16 may be embedded in the surface of the second tube 12 (see Figure 7B). For example, when the wall of the second tube 12 is composed of two layers of material, the marking portion 16 may be located between the two layers of material.
[0148] In some examples, the marking section 16 can be a developing ring.
[0149] In some examples, see Figure 6, there may be multiple markings 16. This allows for a more complete display of the positions of the first tube 11 and the second tube 12 within the target tissue 2.
[0150] In this disclosure, by distributing a plurality of first through holes 111 on a first tube 11 and movably arranging at least a portion of a second tube 12 within the first tube 11, the fluid control device 1 can facilitate segmented fluid delivery when the second tube 12 is moved to allow fluid to flow out from different positions of the first tube 11 through the plurality of first through holes 111. Furthermore, since the second tube 12 moves within the first tube 11 without direct contact with the target tissue 2, friction on the target tissue 2 is reduced, thereby minimizing damage to the target tissue 2. Additionally, since the fluid pressure gradually decreases along the proximal to distal direction, by gradually increasing the area of the plurality of first through holes 111 along the proximal to distal direction, fluid can flow out of the first tube 11 through larger area first through holes 111 at positions with lower pressure, which helps improve the uniformity of fluid flow and thus enhances the fluid's effectiveness.
[0151] In summary, according to this disclosure, a fluid control device 1 with a dual-tube body is provided, which facilitates segmented fluid delivery and reduces damage to the target tissue 2.
[0152] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.
Claims
1. A fluid control device with a dual-tube body, characterized in that, It includes a first tube body, a second tube body in fluid communication with the first tube body, a distal end, and a proximal end; the first tube body has a plurality of first through holes, the area of which gradually increases along the direction from the proximal end to the distal end; the second tube body has an infusion port near the proximal end and a first opening near the distal end, which are in communication with the lumen of the second tube body. At least a portion of the second tube is movably disposed within the cavity of the first tube. Fluid enters the cavity of the second tube through the inlet and flows into the cavity of the first tube through the first opening. The fluid flowing into the cavity of the first tube flows out through the plurality of first through holes.
2. The fluid control device with a dual-tube body according to claim 1, characterized in that, The plurality of first through holes are arranged in groups, and the distance between two adjacent groups gradually decreases along the direction from the proximal end to the distal end.
3. The fluid control device with a dual-tube body according to any one of claims 1 to 2, characterized in that, The first opening includes a plurality of second through holes located in the wall of the second tube.
4. The fluid control device with a dual-tube body according to claim 3, characterized in that, The plurality of second through holes are distributed circumferentially along the second tube body, or axially and circumferentially.
5. The fluid control device with a dual-tube body according to any one of claims 1 to 2 and 4, characterized in that, The distance between the first through hole and the end of the first tube near the proximal end is greater than or equal to a preset distance.
6. The fluid control device with a dual-tube body according to any one of claims 1 to 2 and 4, characterized in that, The distal end of the first tube and / or the distal end of the second tube bends toward the axis away from the fluid control device.
7. The fluid control device with a dual-tube body according to any one of claims 1 to 2 and 4, characterized in that, The elasticity of the first tube and the elasticity of the second tube gradually increase along the direction from the proximal end to the distal end.
8. The fluid control device with a dual-tube body according to any one of claims 1 to 2 and 4, characterized in that, The length of the second tube is greater than the length of the first tube.
9. The fluid control device with a dual-tube body according to any one of claims 1 to 2 and 4, characterized in that, The second tube includes a protrusion disposed on the outer surface of the second tube, the protrusion being closer to the proximal end than the first opening.
10. The fluid control device with a dual-tube body according to any one of claims 1 to 2 and 4, characterized in that, It also includes a marking part, which is embedded in the first tube body and / or the second tube body.