Catheter assembly

Abstract

The catheter assembly comprises an outer tube, an inner tube and a plugging piece, the outer tube comprises a first end hole and a first through hole area, and the first end hole is located in the far end of the outer tube; the inner tube comprises a second end hole and a second through hole area, the second end hole is located at the far end of the second through hole area, the inner tube is movably inserted into the outer tube, and the blocking piece is movably inserted into the inner tube to block the second end hole and the first end hole. According to the technical scheme, the technical problems that a traditional catheter is single in use scene and small in application range, the catheter needs to be inserted and taken out for multiple times to execute different operations, and the trauma to a patient is large are effectively solved.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to a catheter assembly. Background Technology

[0002] Medical catheters are tubular instruments, typically made of soft materials such as silicone and polyurethane. These products have one open end for insertion into a specific part of the body, and the other end connects to external devices for delivering liquids, gases, or drugs. They are widely used in clinical settings, such as in angiography, thrombolysis, and blood pressure monitoring. Traditional catheters are generally specialized for specific purposes. For example, a dedicated angiography catheter is used for angiography to deliver contrast agents or other medical materials to the lesion site, allowing doctors to clearly observe the internal structure of blood vessels or organs using imaging techniques such as X-rays. Similarly, a dedicated thrombolysis catheter is used for thrombolysis to deliver thrombolytic drugs to the lesion site to flush out the thrombus and dissolve it. A dedicated blood pressure monitoring catheter is used to monitor the patient's blood pressure in real time. This results in limited application scenarios and a narrow scope for traditional catheters. Furthermore, when performing angiography, thrombolysis, or blood pressure monitoring simultaneously on the same lesion site, multiple insertions and withdrawals of different specialized catheters are required, increasing the risk of trauma to the patient. Summary of the Invention

[0003] This application provides a catheter assembly and its usage method to solve the technical problems of traditional catheters having limited application scenarios, narrow applicability, and requiring multiple insertions and removals of the catheter to perform different tasks, resulting in significant trauma to patients.

[0004] Therefore, in a first aspect, embodiments of this application provide a catheter assembly, including an outer tube, an inner tube, and a plugging member. The outer tube includes a first end hole and a first through hole region, with the first end hole located at the distal end of the outer tube. The inner tube includes a second end hole and a second through hole region, with the second end hole located at the distal end of the second through hole region. The inner tube is movably inserted into the outer tube, and the plugging member is movably inserted into the inner tube to plug the second end hole and the first end hole.

[0005] In one possible implementation, the second through-hole area gradually narrows along the axial direction of the inner tube.

[0006] In one possible implementation, the length of the second through-hole region along the axial direction of the inner tube is 5 mm to 15 mm; and / or,

[0007] The second through-hole area is provided with multiple second through-holes, the diameter of which is 0.5mm to 1mm.

[0008] In one possible implementation, the inner tube is provided with a developing mark, which is located near the second through-hole area.

[0009] In one possible implementation, the inner tube comprises a polymer layer;

[0010] Alternatively, the inner tube includes an inner liner membrane layer and a polymer layer, with the inner liner membrane layer disposed inside the polymer layer;

[0011] Alternatively, the inner tube may include an inner lining membrane layer, a reinforcing layer, and a polymer layer, which are arranged sequentially from the inside to the outside along the radial direction of the inner tube.

[0012] In one possible implementation, the length of the first through-hole area in the axial direction of the outer tube is 5cm to 50cm.

[0013] In one possible implementation, a plurality of first through holes are provided in the first through hole region, and the diameter of the first through holes gradually increases in the direction from the first end hole to the first through hole region.

[0014] In one possible implementation, the density of the first through-hole gradually increases; and / or,

[0015] The diameter of the first through hole is 0.5mm to 1.2mm.

[0016] In one possible implementation, the outer tube comprises a polymer layer;

[0017] Alternatively, the outer tube includes an inner liner membrane layer and a polymer layer, with the inner liner membrane layer disposed inside the polymer layer;

[0018] Alternatively, the outer tube may include an inner lining membrane layer, a reinforcing layer, and a polymer layer, which are arranged sequentially from the inside to the outside along the radial direction of the inner tube.

[0019] In one possible implementation, the plugging component includes a guide wire, a first plug, and a second plug, with the first plug and the second plug spaced apart at the distal end of the guide wire. The first plug is used to plug a first end hole, and the second plug is used to plug a second end hole.

[0020] In one possible implementation, a plurality of first plugs are provided, and the outer diameter of the first plugs gradually decreases in the direction from the second end hole to the first end hole.

[0021] In one possible implementation, the sealing element further includes a developing ring disposed on the guide wire and located on the side of the first plug away from the second plug.

[0022] Secondly, this application also provides a conduit assembly, including an outer tube and an inner tube, the outer tube having a first through-hole region, the inner tube having a second through-hole region, the inner tube being movably inserted into the outer tube, and at least a portion of the second through-hole region axially coinciding with at least a portion of the first through-hole region.

[0023] Thirdly, this application also provides a catheter assembly, including an outer tube and a plugging member. The outer tube includes a first end hole and a first through hole region, with the first end hole located at the distal end of the first through hole region. The plugging member is movably inserted into the outer tube to plug the first end hole.

[0024] According to the embodiments of this application, the catheter assembly includes an outer tube, an inner tube, and a sealing member. The outer tube includes a first end hole and a first through hole area, with the first end hole located at the distal end of the outer tube. The inner tube includes a second end hole and a second through hole area, with the second end hole located at the distal end of the second through hole area. The inner tube is movably inserted into the outer tube, and the sealing member is movably inserted into the inner tube and the outer tube to seal the second end hole and the first end hole. Compared to traditional medical catheters, which are dedicated to a single purpose, have limited application scenarios, are costly, and pose a risk of trauma to patients due to repeated insertion of dedicated catheters for the same lesion, this application proposes a catheter assembly that is highly versatile, versatile in application scenarios, widely applicable, minimally invasive, and highly safe. The outer tube of this catheter assembly is inserted into subcutaneous tissue to provide an operating environment for the inner tube and / or occluder. Thus, when performing different procedures on the same lesion, only the outer tube needs to be inserted once, and then the inner tube and / or occluder within the outer tube needs to be replaced. This allows for procedures such as angiography, thrombolysis, or blood pressure monitoring at the lesion site, simplifying operation, minimizing patient trauma, and ensuring high safety. The inner tube is movably inserted into the outer tube and can be used independently to achieve segmented angiography at different locations within the first orifice area of ​​the outer tube, reducing contrast agent waste and improving angiographic results. The occluder is movably inserted into the inner tube and works in conjunction with the inner and outer tubes to achieve segmented pressure measurement at different locations within the first orifice area of ​​the outer tube, resulting in high blood pressure monitoring accuracy and strong data reliability. In addition, the sealing component can also work alone with the outer tube to seal different positions in the first through-hole area of ​​the outer tube, achieving segmented thrombolysis with high precision and good thrombolysis effect. Attached Figure Description

[0025] The accompanying drawings, incorporated in and forming part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, those skilled in the art can obtain other drawings based on these drawings without creative effort. One or more embodiments are illustrated by way of example through the corresponding images in the accompanying drawings. These exemplary descriptions do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings represent similar elements. Unless otherwise stated, the figures in the drawings do not constitute a limitation on scale.

[0026] Figure 1 A partial cross-sectional view of the catheter assembly provided in the first embodiment of this application;

[0027] Figure 2 for Figure 1 A magnified view of a portion of the image;

[0028] Figure 3 This is a schematic diagram of the outer tube of the conduit assembly provided in an embodiment of this application;

[0029] Figure 4 This is a schematic diagram of the inner tube of the catheter assembly provided in the embodiments of this application;

[0030] Figure 5 This is a schematic diagram of the sealing element of the catheter assembly provided in the embodiments of this application;

[0031] Figure 6 A partial cross-sectional view of the catheter assembly provided in the second embodiment of this application;

[0032] Figure 7 for Figure 6 A magnified view of a portion of the image;

[0033] Figure 8 A partial cross-sectional view of the catheter assembly provided in the third embodiment of this application;

[0034] Figure 9 for Figure 8 A magnified view of a portion of the image.

[0035] Explanation of reference numerals in the attached figures:

[0036] 100. Outer tube; 110. First end hole; 120. First through hole area;

[0037] 200, Inner tube; 210, Second end hole; 220, Second through hole area;

[0038] 300, sealing component; 310, guide wire; 320, first plug; 330, second plug. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0040] The following disclosure provides numerous different embodiments or examples for implementing various structures of this application. To simplify the disclosure, specific examples of components and arrangements are described below. These are merely examples and are not intended to limit the scope of this application. Furthermore, reference numerals and / or letters may be repeated in different examples. Such repetition is for simplification and clarity and does not in itself indicate a relationship between the various embodiments and / or arrangements discussed. In addition, various specific examples of processes and materials are provided in this application; however, those skilled in the art will recognize the applicability of other processes and / or the use of other materials.

[0041] For ease of description, spatial relative terms may be used in the text to describe the relative position or movement of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "front," "back," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure undergoes a positional flip, orientation change, or change of motion, these directional indications will change accordingly. For instance, an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0042] First Embodiment

[0043] Figure 1 A partial cross-sectional view of the assembled conduit assembly is shown; Figure 2 Show Figure 1 A magnified view of a portion of the image; Figure 3 A schematic diagram of the outer tube 100 is shown; Figure 4 A schematic diagram of the inner tube 200 is shown; Figure 5 A schematic diagram of the sealing component 300 is shown.

[0044] like Figure 1 and Figure 2As shown, this application provides a catheter assembly including an outer tube 100, an inner tube 200, and a sealing member 300. The outer tube 100 includes a first end hole 110 and a first through hole region 120, with the first end hole 110 located at the distal end of the first through hole region 120. The inner tube 200 includes a second end hole 210 and a second through hole region 220, with the second end hole 210 located at the distal end of the second through hole region 220. The inner tube 200 is movably inserted into the outer tube 100, and the sealing member 300 is movably inserted into the inner tube 200 to seal the second end hole 210 and the first end hole 110.

[0045] Compared to traditional medical catheters, which are dedicated to a single purpose, have limited application scenarios, are costly, and pose a risk of trauma to patients due to repeated insertion of dedicated catheters to the same lesion, this application proposes a catheter assembly that is highly versatile, versatile in application scenarios, widely applicable, minimally invasive, and highly safe. The outer tube 100 of this catheter assembly is inserted into subcutaneous tissue to provide an operating environment for the inner tube 200 and / or the occlusion element 300. Thus, when performing different procedures on the same lesion, only the outer tube 100 needs to be inserted once, and then the inner tube 200 and / or the occlusion element 300 within the outer tube 100 need to be replaced. This allows for procedures such as angiography, thrombolysis, or blood pressure monitoring at the lesion site, simplifying operation, minimizing patient trauma, and ensuring high safety. The inner tube 200 is movably inserted into the outer tube 100 and can be used independently with the outer tube 100 to achieve segmented angiography at different locations in the first through-hole area 120 of the outer tube 100, reducing contrast agent waste and improving angiographic results. The sealing component 300 is movably inserted into the inner tube 200 to work in conjunction with the inner tube 200 and the outer tube 100 to achieve segmented pressure measurement at different positions in the first through-hole area 120 of the outer tube 100, resulting in high blood pressure monitoring accuracy and strong data reliability. Alternatively, the sealing component 300 can also work independently with the outer tube 100 to seal different positions in the first through-hole area 120 of the outer tube 100, achieving segmented thrombolysis with high accuracy and good thrombolysis effect.

[0046] Specifically, the catheter assembly is configured as a combination of at least an outer tube 100, an inner tube 200, and an occlusion element 300. The outer tube 100 can be a long tubular structure, which can include five parts: a catheter seat, a stress-relieving element, a proximal segment, a distal segment, and a tip. The catheter seat and the stress-relieving element are exposed to the skin tissue, at least a portion of the proximal segment extends into the skin tissue, and the distal segment and the tip fully extend into the skin tissue to establish a working channel within the skin tissue. This working channel connects the external environment and the lesion site. The outer tube 100 can be formed by heat-melting 1 to 3 layers of polymer / braided mesh or springs, etc., and has high flexibility. The inner tube 200 can be a long tubular structure with an inner diameter smaller than that of the outer tube 100, allowing it to be moved back and forth within the outer tube 100. The inner tube 200 can include five parts: a catheter seat, a stress-relieving element, a proximal segment, a distal segment, and a tip. The proximal segment, distal segment, and tip of the inner tube 200 are inserted into the proximal and distal segments of the outer tube 100 from the catheter seat and stress-relieving element side of the outer tube 100, so as to cooperate with the outer tube 100 to release different compounds, such as contrast agents and thrombolytic drugs, to the lesion site. The inner tube 200 can be made by heat-melting 1 to 3 layers of polymer / woven mesh or springs, etc., and has high flexibility. The occlusion element 300 can be a wire-like structure, providing enhanced rigidity and a degree of flexibility. For example, the occlusion element 300 can be a shape memory alloy component, allowing it to move back and forth within the inner tube 200. The occlusion element 300 is equipped with an occlusion ball, which can seal the first end hole 110 of the outer tube 100 and / or the second end hole 210 of the inner tube 200, working in conjunction with the inner tube 200 and the outer tube 100 to achieve blood pressure monitoring at the lesion site. The catheter assembly provided in this example, through the coordinated operation of the outer tube 100, the inner tube 200, and the occlusion element 300, can achieve blood pressure monitoring at different locations within the lesion site. The blood pressure monitoring data is highly accurate and reliable, which is beneficial for doctors to understand the patient's condition.

[0047] Based on the above, the operation process of the segmented blood pressure monitoring of the catheter assembly provided in this embodiment is as follows: First, the outer tube 100 is inserted into the subcutaneous tissue to connect the external environment and the lesion site. At this time, the first through-hole area 120 covers the designated pressure measurement position and radiates outward to a certain blood pressure monitoring area. Then, the inner tube 200 is inserted into the outer tube 100 and connected and secured to the outer tube 100 through the Y valve. At this time, the second through-hole area 220 of the inner tube 200 can partially overlap with the first through-hole area 120 or be completely contained within the first through-hole area 120. Then, the sealing member 300 is inserted into the inner tube 200 to seal the second end hole 210 at the distal end of the inner tube 200. During pressure measurement, the occluder 300 is pushed to the farthest end of the inner tube 200, sealing the second end hole 210 to prevent the inner lumen of the inner tube 200 from communicating with the blood supply to the lesion site through the second end hole 210. Then, the catheter seat side of the inner tube 200 is connected to the pressure measuring device via the Y valve, thus enabling pressure monitoring of the lesion area. When it is necessary to measure blood pressure data at different locations, the inner tube 200 can be moved forward or backward to position the second end hole 210 at different locations, thereby enabling blood pressure monitoring at different locations. It is understood that the occluder 300 always seals the second end hole 210 during the movement of the inner tube 200.

[0048] like Figure 1 , Figure 2 and Figure 4 As shown, in one possible implementation, the second through-hole region 220 gradually narrows along the axial direction of the inner tube 200. The distal end of the inner tube 200 provided in this example has a constricted structure, which can be used in conjunction with the sealing member 300 to seal the second end hole 210 of the inner tube 200 during blood pressure monitoring, improving the following relationship between the inner tube 200 and the sealing member 300. It should be explained that the inner diameter of the second through-hole region 220 is slightly larger than the outer diameter of the sealing member 300, so that the sealing member 300 can be inserted and moved back and forth along the axial direction of the inner tube 200.

[0049] like Figure 1 and Figure 4 As shown, in one possible implementation, the length of the second through-hole region 220 in the axial direction of the inner tube 200 is 5mm to 15mm. This configuration ensures that the length of the opening area on the inner tube 200 is within a suitable range, preventing the second through-hole region 220 from being too long and affecting the rigidity of the distal end of the inner tube 200, or the sealing effect of the sealing element 300 on the second end hole 210 at the distal end of the inner tube 200 during blood pressure monitoring. Alternatively, it prevents the second through-hole region 220 from being too short and affecting the release efficiency of the contrast agent during angiography, thereby improving the accuracy and reliability of blood pressure monitoring data and enhancing the angiography efficiency and effect. For example, but not limited to, the length of the second through-hole region 220 can be 7mm, 9mm, 10mm, 11mm, 13mm, or 14mm.

[0050] like Figure 1 and Figure 4 As shown, in one possible implementation, the second through-hole region 220 is provided with a plurality of second through-holes, the diameter of which is 0.5 mm to 1 mm. The plurality of second through-holes provided in this example are distributed at intervals along the axial direction of the inner tube 200 on the sidewall of the distal end of the inner tube 200 to connect the inner cavity of the inner tube 200 and the inner cavity of the outer tube 100; for example, but not limited to, the number of second through-holes in the second through-hole region 220 is 4 to 10, such as 5, 6, 7, 8, or 9. The plurality of second through-holes can be on the same horizontal line for ease of processing; or they can be distributed in a spiral pattern to release the contrast agent on the periphery of the inner tube 200, improving the uniformity of contrast agent distribution and enhancing the contrast effect. The diameter of the second through hole is within a suitable range of 0.5mm to 1mm. This avoids the situation where the diameter of the second through hole is too large, resulting in poor rigidity at the distal end of the inner tube 200 and affecting the sealing effect of the sealing element 300 on the second end hole 210 at the distal end of the inner tube 200 during blood pressure monitoring. Alternatively, it avoids the situation where the diameter of the second through hole is too small, resulting in slow contrast agent release efficiency and improving the synergistic effect of the catheter assembly. For example, but not limited to, the diameter of the second through hole is 0.6mm, 0.7mm, 0.8mm, or 0.9mm.

[0051] In one possible implementation, the inner tube 200 is provided with a radiopaque marker (not shown in the figure), which is positioned near the second through-hole area 220. The radiopaque marker provided in this example is radiopaque under X-ray and is used to locate the distal end of the inner tube 200, facilitating accurate measurement of blood pressure at locations other than those requiring X-ray penetration by physicians. This improves the accuracy and reliability of blood pressure monitoring data and has significant clinical guidance value.

[0052] In one possible implementation, the inner tube 200 includes a polymer layer;

[0053] Alternatively, the inner tube 200 includes an inner liner membrane layer and a polymer layer, with the inner liner membrane layer disposed inside the polymer layer;

[0054] Alternatively, the inner tube 200 may include an inner lining membrane layer, a reinforcing layer, and a polymer layer, which are arranged sequentially from the inside to the outside along the radial direction of the inner tube 200.

[0055] In this embodiment, the inner tube 200 can be made solely from a polymer to save raw materials and reduce costs. This polymer can be any of Pebax, PA, PE, etc., for example, but not limited to, the inner tube 200 is injection molded from PE. The inner tube 200 provided in this example is low-cost and simple to process.

[0056] In one example, the inner tube 200 can be a double-layer structure, with an inner liner membrane layer and an outer polymer layer. The two layers can be joined together by heat fusion or by adhesive bonding. The liner membrane can be PTFE. The inner tube 200 provided in this example has a moderate cost and a relatively simple processing technology.

[0057] In one example, the inner tube 200 can also be a three-layer structure, with an inner lining membrane layer, a middle reinforcing layer, and an outer polymer layer. These three layers can be joined together by heat fusion or by adhesive bonding. The reinforcing layer can be a stainless steel braided mesh or a stainless steel spring, etc. The inner tube 200 provided in this example has high structural strength, enhanced stability, and a long service life.

[0058] In one possible implementation, the length of the first through-hole area 120 along the axial direction of the outer tube 100 is 5cm to 50cm. This configuration ensures that the length of the opening area on the outer tube 100 is within a suitable range, avoiding either excessive length leading to increased processing difficulty and production costs, or excessive length preventing angiography operations. This reduces the processing difficulty and production cost of the outer tube 100, expands the scope of angiography, thrombolysis, and blood pressure monitoring, and allows the catheter assembly to be used for lesions with large areas of lesions, thus increasing the applicability and application scenarios of the catheter assembly. For example, but not limited to, the length of the first through-hole area 120 can be 10cm, 15cm, 20cm, 25cm, 30cm, 35cm, 40cm, or 45cm.

[0059] like Figure 1 , Figure 2 and Figure 3 As shown, in one possible implementation, a plurality of first through holes are provided within the first through hole region 120, and the diameter of the first through holes gradually increases in the direction from the first end hole 110 to the first through hole region 120. This arrangement can improve the uniformity of thrombolytic drug release in the axial direction and enhance the thrombolytic effect.

[0060] In one example, multiple first through holes are spaced apart along the axial direction of the outer tube 100 on the distal sidewall of the outer tube 100 to connect the inner lumen of the outer tube 100 with the subcutaneous tissue environment. The multiple first through holes can be on the same horizontal line for ease of fabrication; or they can be arranged in a spiral pattern to allow for the release of contrast agents or thrombolytic drugs at the periphery of the outer tube 100, improving the uniformity of contrast agent / thrombolytic drug distribution and enhancing the contrast and thrombolytic effects. The number of first through holes in 1 cm of the first through hole region 120 is 3 to 12. For example, but not limited to, the number of first through holes in 1 cm of the first through hole region 120 is 4, 5, 6, 8, or 10.

[0061] In one possible implementation, the density of the first through-hole gradually increases. This arrangement can reduce the pressure at the distal end of the first through-hole region 120, which is beneficial for the release of contrast agents or thrombolytic drugs, improves the uniformity of axial release of contrast agents or thrombolytic drugs, and enhances the contrast and thrombolytic effects.

[0062] In one possible implementation, the diameter of the first through-hole is 0.5 mm to 1.2 mm. The diameter of the first through-hole provided in this example is within a suitable range, which can avoid the situation where an excessively large diameter would result in poor rigidity at the distal end of the outer tube 100, affecting the sealing effect of the sealing element 300 at the distal end of the outer tube 100 during thrombolysis. Alternatively, it can avoid the situation where an excessively small diameter would result in slow release of contrast agent and thrombolytic drugs, thereby improving thrombolysis efficiency and effect, improving contrast efficiency and effect, and improving the synergistic effect of the catheter assembly. For example, but not limited to, the diameter of the first through-hole is 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1.0 mm.

[0063] In one possible implementation, the outer tube 100 includes a polymer layer;

[0064] Alternatively, the outer tube 100 includes an inner liner membrane layer and a polymer layer, with the inner liner membrane layer disposed inside the polymer layer;

[0065] Alternatively, the outer tube 100 may include an inner lining membrane layer, a reinforcing layer, and a polymer layer, which are arranged sequentially from the inside to the outside along the radial direction of the inner tube 200.

[0066] In this embodiment, the outer tube 100 can be made solely from a polymer to save raw materials and reduce costs. This polymer can be any of Pebax, PA, PE, etc., for example, but not limited to, the outer tube 100 is injection molded from PE. The outer tube 100 provided in this example is low-cost and simple to process.

[0067] In one example, the outer tube 100 can be a double-layer structure, with an inner liner membrane layer and an outer polymer layer. The two layers can be joined together by heat fusion or by adhesive bonding. The liner membrane can be PTFE. The outer tube 100 provided in this example has a moderate cost and a relatively simple processing technology.

[0068] In one example, the outer tube 100 can also be a three-layer structure, with an inner lining membrane layer, a middle reinforcing layer, and an outer polymer layer. These three layers can be joined together by heat fusion or by adhesive bonding. The reinforcing layer can be a stainless steel braided mesh or a stainless steel spring, etc. The outer tube 100 provided in this example has high structural strength, enhanced stability, and a long service life.

[0069] like Figure 1 , Figure 2 and Figure 5 As shown, in one possible implementation, the sealing member 300 includes a guide wire 310, a first plug 320 and a second plug 330. The first plug 320 and the second plug 330 are spaced apart at the distal end of the guide wire 310. The first plug 320 is used to block the first end hole 110 and the second plug 330 is used to block the second end hole 210.

[0070] In this embodiment, the specific configuration of the occlusion element 300 is optimized. Specifically, the occlusion element 300 is configured as a combination of at least a guidewire 310, a first plug 320, and a second plug 330. The guidewire 310 can be a metal wire, which combines rigidity and flexibility, allowing the occlusion element 300 to move back and forth along the axial direction of the inner tube 200 / outer tube 100 under the action of axial force, thereby realizing the relative position adjustment of the occlusion element 300 with the inner tube 200 / outer tube 100, which is beneficial for segmented / localized operations of the catheter assembly. The first plug 320 can be a spherical or ellipsoidal metal structure, used to block the first end hole 110 of the outer tube 100 during thrombolysis, so that the thrombolytic drug can only be released from the first through hole in the first through hole area 120, thereby dissolving the thrombus. The second plug 330 can be a spherical metal structure, used to block the second end hole 210 of the inner tube 200 during blood pressure monitoring operations, so as to isolate the external air pressure and the blood pressure at the lesion site, and realize blood pressure monitoring at the second end hole 210, making it convenient for doctors to monitor the patient's blood pressure level.

[0071] In one example, the cross-sectional shape of the sealing element 300 along its radial direction can be any of the following: circular, rectangular, dumbbell-shaped, club-shaped, or elliptical. The specific cross-sectional shape of the sealing element 300 is not limited here, as long as it can achieve the sealing effect.

[0072] like Figure 5 As shown, in one possible implementation, multiple first plugs 320 are provided, and the outer diameter of the first plugs 320 gradually decreases in the direction from the second end hole 210 to the first end hole 110. The multiple first plugs 320 provided in this example are spaced apart along the axial direction of the guidewire 310 at the distal end of the guidewire 310. This increases the contact area with the thrombus through the distal first plugs 320, thereby utilizing the surface tension of the first plugs 320 to adsorb and attach the thrombus on that side to the distal first plug 320. This prevents the thrombus from being completely attached to the proximal first plug 320 and entering the inner cavity of the outer tube 100, thus blocking the outer tube 100. This reduces the resistance between the first plugs 320 and the outer tube 100, facilitates the back-and-forth movement of the first plugs 320, and improves the mobility of the sealing member 300.

[0073] In one possible implementation, the sealing member 300 further includes a developing ring (not shown in the figure), which is disposed on the guide wire 310 and located on the side of the first plug 320 away from the second plug 330.

[0074] In this embodiment, the specific configuration of the occlusion component 300 is further optimized. Specifically, the occlusion component 300 is configured as a combination of at least a guidewire 310, a first plug 320, a second plug 330, and a contrast ring. The contrast ring can be located at the distal end of the guidewire 310 to position the first plug 320, so as to perform precise thrombolysis on the local thrombus at the lesion site, thereby improving the accuracy and effectiveness of thrombolysis.

[0075] In addition, such as Figure 1 and Figure 2 As shown, this application also provides a method of using the catheter assembly as described above, comprising the following steps:

[0076] Clean and lubricate the outer tube 100, inner tube 200, and sealing component 300;

[0077] An arterial inlet was established using a percutaneous puncture technique, and the outer cannula 100 was advanced along the guidewire 310 to the lesion site.

[0078] Insert the inner tube 200 into the outer tube 100, and adjust the position of the second end hole 210 of the inner tube 200 in the first through hole area 120 of the outer tube 100 according to the blood pressure measurement position.

[0079] Insert the sealing component 300 into the inner tube 200 to seal the second end hole 210 and the first end hole 110.

[0080] This embodiment provides a method for real-time blood pressure monitoring using the catheter assembly provided in this embodiment: First, the outer tube 100, inner tube 200, and occluder 300 are flushed with heparinized saline to avoid interference from impurities and bacterial infection; then, the outer tube 100, inner tube 200, and occluder 300 are immersed in heparinized saline to lubricate their outer surfaces, facilitating subsequent insertion into subcutaneous tissue. Next, an arterial inlet is established using percutaneous puncture, and the outer tube 100 is inserted under the guidance of a guidewire 310, so that the distal end of the outer tube 100 is inserted at the lesion site. Next, the inner tube 200 is inserted into the inner cavity of the outer tube 100 via the Y-valve. The relative position of the distal end of the inner tube 200 and the first through-hole area 120 of the outer tube 100 is adjusted according to the blood pressure monitoring location, allowing for blood pressure monitoring at different locations within the lesion site, achieving local / segmented blood pressure monitoring. Simultaneously, the sealing member 300 is inserted into the inner cavity of the inner tube 200 via the Y-valve, sealing the second end hole 210 of the inner tube 200, completing the assembly of the blood pressure monitoring catheter assembly. Finally, the catheter seat end of the inner tube 200 is connected to the pressure measuring device via the Y-valve to achieve real-time monitoring of blood pressure at the second end hole 210 at the distal end of the inner tube 200. When blood pressure monitoring is required at other sites, there is no need to pull the outer tube 100; simply pull the inner tube 200 and the sealing device 300. The operation is simple and convenient, and will not cause secondary trauma to the patient, ensuring high safety. The location of blood pressure monitoring can be confirmed by the contrast marker on the distal end of the inner tube 200. By repeating the above blood pressure monitoring steps, local / segmental blood pressure monitoring can be achieved, resulting in high accuracy and reliability of blood pressure data, which is beneficial for doctors to accurately grasp the patient's blood pressure.

[0081] Second Embodiment

[0082] Figure 6 A partial cross-sectional view of the assembled conduit assembly is shown; Figure 7 Show Figure 6 A magnified view of a portion of the image.

[0083] like Figure 6 and Figure 7 As shown, this application also provides a catheter assembly, including an outer tube 100 and an inner tube 200. The outer tube 100 has a first through-hole region 120, and the inner tube 200 has a second through-hole region 220. The inner tube 200 is movably inserted into the outer tube 100, and at least a portion of the second through-hole region 220 axially coincides with at least a portion of the first through-hole region 120. The difference between this embodiment and the first embodiment is that only the outer tube 100 and the inner tube 200 are selected for interventional surgery to achieve angiography at the lesion site.

[0084] In this embodiment, a catheter assembly is provided for use as an imaging technique. The outer tube 100 is inserted into the subcutaneous tissue, and the inner tube 200 can be pushed back and forth within the outer tube 100 to achieve imaging of the first through-hole area 120 of the outer tube 100, as well as targeted imaging of specific locations within the first through-hole area 120, reducing contrast agent waste and improving imaging efficacy. The contrast agent enters the outer tube 100 through the inner lumen of the inner tube 200 via the second end hole 210 and the second through-hole in the second through-hole area 220, and flows out through the first through-hole in the first through-hole area 120 of the outer tube 100, thereby achieving imaging of the lesion site. The catheter assembly provided in this example can achieve localized and segmented imaging of the lesion site, reducing contrast agent waste and providing good imaging efficacy.

[0085] In addition, such as Figure 6 and Figure 7 As shown, this application also provides a method of using the catheter assembly as described above, comprising the following steps:

[0086] Clean and lubricate the outer tube 100 and the inner tube 200;

[0087] An arterial inlet was established using a percutaneous puncture technique, and the outer cannula 100 was advanced along the guidewire 310 to the lesion site.

[0088] Insert the inner tube 200 into the outer tube 100, and adjust the position of the second end hole 210 and the second through hole area 220 of the inner tube 200 in the first through hole area 120 of the outer tube 100 according to the imaging position.

[0089] This embodiment provides a method for performing angiography using the catheter assembly provided in this embodiment: First, the outer tube 100 and inner tube 200 are flushed with heparinized saline to avoid interference from impurities and bacterial infection; then, the outer tube 100 and inner tube 200 are immersed in heparinized saline to lubricate their outer surfaces, facilitating subsequent insertion into subcutaneous tissue. Next, the inner tube 200 is inserted into the lumen of the outer tube 100 through the Y valve and gently pushed forward until the second end hole 210 of the inner tube 200 covers the farthest first through hole on the first through hole area 120 of the outer tube 100, completing the assembly of the catheter assembly for angiography. Next, an arterial inlet is established using percutaneous puncture, and the aforementioned outer tube 100 and inner tube 200 are simultaneously inserted under the guidance of guidewire 310 to improve angiography efficiency. Under X-ray guidance, the outer tube 100 is moved to the distal end of the lesion site. At this time, the position of the inner tube 200 can be adjusted so that the distal end of the inner tube 200 (i.e., the second end hole 210) reaches the position required for angiography, thereby enabling local release of contrast agent at the lesion site to achieve local / segmental angiography. Finally, contrast agent is introduced into the inner tube 200. The contrast agent flows through the lumen of the inner tube 200 and flows into the lumen of the outer tube 100 from the second through hole in the second through hole area 220 of the inner tube 200 and the second end hole 210. It then flows out from the first through hole in the first through hole area 120 of the outer tube 100 and acts on the tissues surrounding the lesion site to form the required angiography. This angiographic image can be projected onto a fluorescent screen and recorded. When angiography is required on other parts of the body, there is no need to pull the outer tube 100; simply pull the inner tube 200 directly. The operation is simple and convenient, and will not cause secondary trauma to the patient, ensuring high safety. The angiography location is confirmed by the contrast marker on the distal end of the inner tube 200. By repeating the above angiography steps, segmental angiography can be performed on different locations, resulting in high angiography accuracy and good angiography effect.

[0090] Third Embodiment

[0091] Figure 8 A partial cross-sectional view of the assembled conduit assembly is shown; Figure 9 Show Figure 8 A magnified view of a portion of the image.

[0092] like Figure 8 and Figure 9 As shown, this application also provides a catheter assembly, including an outer tube 100 and a occlusion element 300. The outer tube 100 includes a first end hole 110 and a first through-hole region 120, with the first end hole 110 located at the distal end of the first through-hole region 120. The occlusion element 300 is movably inserted into the outer tube 100 to block the first end hole 110. The difference between this embodiment and the first embodiment is that only the outer tube 100 and the occlusion element 300 are selected for interventional surgery to achieve thrombolysis at the lesion site.

[0093] In this embodiment, a catheter assembly is provided for use as a thrombolytic therapy. The outer tube 100 is inserted into the subcutaneous tissue, and the occlusion element 300 can be pushed back and forth within the outer tube 100 to deliver thrombolytic drugs to the first through-hole area 120 of the outer tube 100, and to deliver thrombolytic drugs to specific locations within the first through-hole area 120, improving the accuracy and efficacy of thrombolysis. The occlusion element 300 blocks the first end hole 110, allowing the thrombolytic drug to flow through the inner lumen of the outer tube 100 and out through the first through-hole in the first through-hole area 120 of the outer tube 100, delivering the drug to the lesion site and dissolving the thrombus at the lesion site. The catheter assembly provided in this example can achieve localized and segmented thrombolysis at the lesion site, with precise drug delivery and good thrombolytic effect.

[0094] In addition, such as Figure 8 and Figure 9 As shown, this application also provides a method of using the catheter assembly as described above, comprising the following steps:

[0095] Clean and lubricate the outer tube 100 and the sealing component 300;

[0096] An arterial inlet was established using a percutaneous puncture technique, and the outer cannula 100 was advanced along the guidewire 310 to the lesion site.

[0097] The occlusion element 300 is inserted into the outer tube 100, and the occlusion position of the occlusion element 300 in the first through-hole area 120 of the outer tube 100 is adjusted according to the length and location of the thrombus.

[0098] This embodiment provides a method for thrombolysis using the catheter assembly provided in this embodiment: First, the outer tube 100 and the occluder 300 are flushed with heparinized saline to avoid interference from impurities and bacterial infection; then, the outer tube 100 and the occluder 300 are immersed in heparinized saline to lubricate their outer surfaces, facilitating subsequent insertion into subcutaneous tissue. Next, an arterial inlet is established using percutaneous puncture, and the outer tube 100 is inserted under the guidance of a guidewire 310; then, the occluder 300 is inserted into the lumen of the outer tube 100 through a Y-valve, and its position is adjusted according to the thrombus length and location. Finally, thrombolytic drugs are injected into the lumen of the outer tube 100 through the Y-valve. The thrombolytic drugs flow through the lumen of the outer tube 100 and out through the first through-hole in the first through-hole area 120 of the outer tube 100, acting on the thrombus at the lesion site to perform thrombolysis; the thrombolysis image can be projected onto a fluorescent screen and recorded. After a period of thrombolysis, the thrombus clearance is reassessed using angiography. If local thrombus is present, the outer tube 100 does not need to be pulled; the occlusion device 300 can be pulled directly instead. This operation is simple and convenient, and will not cause secondary trauma to the patient, ensuring high safety. The location of the thrombolysis is confirmed by the contrast ring on the distal end of the occlusion device 300. The above thrombolysis steps are repeated to achieve local / segmented thrombolysis with high precision and good thrombolysis effect.

[0099] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0100] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0101] The above description is merely a specific embodiment of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A catheter assembly, characterized in that, The device includes an outer tube, an inner tube, and a sealing component. The outer tube includes a first end hole and a first through hole area, with the first end hole located at the distal end of the outer tube. The inner tube includes a second end hole and a second through hole area, with the second end hole located at the distal end of the second through hole area. The inner tube is movably inserted into the outer tube, and the sealing component is movably inserted into the inner tube to seal the second end hole and the first end hole.

2. The catheter assembly according to claim 1, characterized in that, Along the axial direction of the inner tube, the second through-hole area gradually narrows.

3. The catheter assembly according to claim 1, characterized in that, In the axial direction of the inner tube, the length of the second through-hole area is 5mm to 15mm; and / or, The second through-hole area is provided with a plurality of second through holes, the diameter of which is 0.5mm to 1mm.

4. The catheter assembly according to claim 1, characterized in that, The inner tube is provided with a developing mark, which is located near the second through hole area.

5. The catheter assembly according to any one of claims 1 to 4, characterized in that, The inner tube includes a polymer layer; Alternatively, the inner tube may include an inner liner membrane layer and a polymer layer, wherein the inner liner membrane layer is disposed inside the polymer layer; Alternatively, the inner tube may include an inner lining membrane layer, a reinforcing layer, and a polymer layer, wherein the inner lining membrane layer, the reinforcing layer, and the polymer layer are arranged sequentially from the inside to the outside along the radial direction of the inner tube.

6. The catheter assembly according to claim 1, characterized in that, Along the axial direction of the outer tube, the length of the first through-hole area is 5cm to 50cm.

7. The catheter assembly according to claim 1, characterized in that, The first through-hole area is provided with a plurality of first through holes, and the diameter of the first through holes gradually increases in the direction from the first end hole to the first through-hole area.

8. The catheter assembly according to claim 7, characterized in that, The density of the first through-hole gradually increases; and / or, The diameter of the first through hole is 0.5mm to 1.2mm.

9. The catheter assembly according to any one of claims 6 to 8, characterized in that, The outer tube includes a polymer layer; Alternatively, the outer tube may include an inner liner membrane layer and a polymer layer, wherein the inner liner membrane layer is disposed inside the polymer layer; Alternatively, the outer tube may include an inner lining membrane layer, a reinforcing layer, and a polymer layer, wherein the inner lining membrane layer, the reinforcing layer, and the polymer layer are arranged sequentially from the inside to the outside along the radial direction of the inner tube.

10. The catheter assembly according to claim 1, characterized in that, The sealing component includes a guide wire, a first plug, and a second plug. The first plug and the second plug are spaced apart at the distal end of the guide wire. The first plug is used to seal the first end hole, and the second plug is used to seal the second end hole.

11. The catheter assembly according to claim 10, characterized in that, The first plug is provided in multiple parts, and the outer diameter of the first plug gradually decreases in the direction from the second end hole to the first end hole.

12. The catheter assembly according to claim 10, characterized in that, The sealing component also includes a developing ring, which is disposed on the guide wire and located on the side of the first plug away from the second plug.

13. A catheter assembly, characterized in that, It includes an outer tube and an inner tube, the outer tube having a first through-hole area and the inner tube having a second through-hole area, the inner tube being movably inserted into the outer tube, and at least a portion of the second through-hole area axially coinciding with at least a portion of the first through-hole area.

14. A catheter assembly, characterized in that, The device includes an outer tube and a sealing element. The outer tube includes a first end hole and a first through hole area, with the first end hole located at the distal end of the first through hole area. The sealing element is movably inserted into the outer tube to seal the first end hole.

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