Medical part, pushing part and guiding device

Abstract

The invention relates to the technical field of medical instruments, and discloses a medical part, a pushing part and a guiding device.The medical part comprises a guiding pipe body, a plurality of through holes are formed in the side wall of the guiding pipe body, and the guiding pipe body has an extending configuration in an extending state and an expanding configuration in an expanding state; the axial length of the extension configuration is larger than that of the expansion configuration, and the outer diameter of the extension configuration is smaller than that of the expansion configuration; the supporting tube body is coaxially connected with the near end of the guiding tube body; the axial length of the guiding pipe body is larger than that of the supporting pipe body. The length of the guide tube body is increased, the coverage range of the through holes formed in the guide tube body is larger, the long-section blood drainage requirement can be met in a targeted mode, and the clinical applicability is improved.

Description

Technical Field

[0001] The present invention relates to the field of extracorporeal circulation systems, and in particular to a medical component, a pushing component and a guiding device. Background Art

[0002] The venous and arterial cannulas in extracorporeal circulation are the core pipelines connecting the patient's circulatory system with the extracorporeal circulation circuit during cardiac surgery, jointly maintaining artificial heart and lung function. The venous cannula mainly connects the patient's venous system with the extracorporeal circulation circuit, responsible for drawing out oxygen-deficient venous blood from the body and sending it to the oxygenator for oxygenation and carbon dioxide removal. It is a key component of "blood extraction" in extracorporeal circulation. The arterial cannula connects the oxygenator with the patient's arterial system and is responsible for pumping oxygenated, oxygen-rich blood back into the patient's artery, completing the function of "blood re-transfusion". It is the core pathway for maintaining systemic blood flow.

[0003] Currently, both types of cannulas utilize a fixed outer diameter tubing structure. To maintain adequate blood flow, the cannulas typically require a larger outer diameter, making insertion difficult in tortuous vessels and posing a risk of vascular damage. Summary of the Invention

[0004] In view of this, the present invention provides a medical component, a pushing component and a guiding device to solve the problem that the current guide tube body is short and the support tube body is long, resulting in the through hole only covering a local area and failing to meet the drainage needs of long sections of blood.

[0005] In a first aspect, the present invention provides a medical device comprising:

[0006] The guide tube body has a plurality of through holes formed on its side wall. The guide tube body has an extended configuration in an extended state and an expanded configuration in an expanded state. The axial length of the extended configuration is greater than the axial length of the expanded configuration, and the outer diameter of the extended configuration is smaller than the outer diameter of the expanded configuration. When the guide tube body is converted from the expanded configuration to the extended configuration, the axial length of the guide tube body is extended and the outer diameter of the guide tube body is reduced. When the guide tube body is converted from the extended configuration to the expanded configuration, the axial length of the guide tube body is reduced and the outer diameter of the guide tube body is increased.

[0007] The supporting tube body is connected to the proximal end of the guiding tube body.

[0008] The beneficial effects of the above-mentioned medical device are as follows: the guide tube body can be switched to an extended configuration during the insertion stage, forming a more slender shape, significantly reducing insertion resistance, and facilitating smooth advancement to the target location in complex vascular pathways. The small outer diameter design of the extended configuration can reduce the friction area and contact pressure between the guide tube body and the inner wall of the blood vessel during insertion, avoiding damage to the vascular endothelium caused by forced pushing. After insertion, the guide tube body can be switched to an expanded configuration, increasing the blood drainage flow by expanding the cross-sectional area of ​​the lumen, ensuring that the extracorporeal circulation system receives sufficient blood supply, and avoiding circulatory instability caused by insufficient flow.

[0009] In an optional embodiment, the axial length of the guide tube body is greater than the axial length of the support tube body.

[0010] The beneficial effects of the above technical solution are as follows: by extending the length of the guide tube, the through-holes provided therein cover a wider area, specifically addressing the need for long-distance blood drainage and improving clinical applicability. Furthermore, the rigidity of the supporting tube helps the guide tube maintain its shape, enhancing the reliability of the overall structure.

[0011] In an optional embodiment, at least one of the guide tube body and the support tube body is a tube body having a reinforcement layer.

[0012] The beneficial effect of the above technical solution is that the reinforcement layer compensates for the weakening of the structure caused by the through hole. Even if the axial length of the guide tube body is significantly increased, for example, the axial length of the guide tube body is greater than that of the support tube body, its anti-deformation ability can still remain stable, thereby improving the guide tube body to achieve long-segment blood drainage coverage while avoiding mesh collapse.

[0013] In an optional embodiment, the support tube body is a multi-layer tube and includes at least one first reinforcement layer, and the first reinforcement layer is a braided component, a wound component, or a hypotube cutting component.

[0014] The beneficial effects of this technical solution are as follows: the first reinforcement layer can withstand axial compression, preventing the support tube from shortening or partially collapsing due to excessive force during pushing, ensuring that the thrust is effectively transmitted to the distal guide tube. The braided or coiled first reinforcement layer forms a grid-like support framework, which disperses the radial pressure generated by vascular compression, preventing the support tube from deforming under pressure, leading to stenosis of the lumen and impaired blood flow.

[0015] In an optional embodiment, the support tube body includes an inner layer tube of the support tube body, a first reinforcement layer and an outer layer tube of the support tube body. The inner layer tube of the support tube body, the first reinforcement layer and the outer layer tube of the support tube body are arranged in sequence from the inside to the outside, and the wall thickness of the outer layer tube of the support tube body gradually increases from the distal end to the proximal end or is of equal thickness.

[0016] In an optional embodiment, the support tube body includes an inner layer tube of the support tube body and a first reinforcement layer, and the inner layer tube of the support tube body and the first reinforcement layer are arranged in sequence from the inside to the outside, and the first reinforcement layer has multiple first reinforcement layer gaps. The inner layer tube of the support tube body fills the first reinforcement layer gaps from the inside to the outside and diffuses to the outer surface of the first reinforcement layer or does not diffuse to the outer surface of the first reinforcement layer.

[0017] The beneficial effects of the above technical solution are: when the inner tube of the support tube body fills the gaps in the first reinforcement layer from the inside to the outside and diffuses to the outer surface of the first reinforcement layer, the interface between the layers is further eliminated, forming a continuous structure of inner tube-reinforcement layer-outer layer, avoiding the risk of delamination; if it does not diffuse, the inner layer material filling the gap can also fix the first reinforcement layer by physical interlocking to prevent it from shifting or loosening. After the gaps in the first reinforcement layer are filled with the inner tube material, the support units of the first reinforcement layer are connected into a whole through the inner layer material. When pushing, the axial thrust can be evenly transmitted to the first reinforcement layer through the inner layer material, avoiding fracture or deformation caused by local stress concentration. The filled inner layer material can buffer the deformation of the first reinforcement layer when subjected to radial pressure. At the same time, the first reinforcement layer provides rigid support for the inner tube. The two work together to improve the compressive resistance of the support tube body.

[0018] In an optional embodiment, the support tube body includes a first reinforcement layer and an outer layer of the support tube body, the first reinforcement layer and the outer layer of the support tube body are arranged in sequence from the inside to the outside, the first reinforcement layer has a plurality of first reinforcement layer gaps, and the outer layer of the support tube body fills the first reinforcement layer gaps from the outside to the inside and diffuses to the inner surface of the first reinforcement layer or does not diffuse to the inner surface of the first reinforcement layer.

[0019] The beneficial effects of the above technical solution are as follows: the outer tube material will flow during the molding process and fill the gaps in the first reinforcement layer, forming a physical fit between the outer layer material and the reinforcement layer gaps, so that the outer tube and the first reinforcement layer are tightly combined, avoiding delamination caused by pushing force or blood vessel compression. If the outer tube material diffuses to the inner surface of the first reinforcement layer, a continuous whole of the outer tube-first reinforcement layer-inner layer is formed, eliminating the interface between the layers; if it does not diffuse, the outer layer material filling the gaps still fixes the reinforcement layer through the fit to prevent it from shifting or loosening. After the gaps in the first reinforcement layer are filled with the outer tube material, the support units are connected into a whole through the outer layer material. During pushing, the axial thrust can be evenly transmitted to the reinforcement layer through the outer layer material, avoiding fracture or deformation of the reinforcement layer caused by local stress concentration.

[0020] In an optional embodiment, the guide tube body includes:

[0021] The guide tube body has an inner cavity;

[0022] The distal head is arranged at the distal end of the guide tube body and connected to the guide tube body. The distal head is suitable for abutting against the pushing member inserted into the inner cavity of the guide tube body, and drives the guide tube body and the support tube body to move under the push of the pushing member.

[0023] In an optional embodiment, the guide tube body includes a second reinforcement layer, which is a braided component, a wound component, or a hypotube cutting component.

[0024] The beneficial effects of this technical solution are as follows: the braided or coiled reinforcement layer forms a grid-like support framework, distributing the radial pressure generated by vascular compression, preventing collapse of the guide tube due to localized excessive force, and ensuring the continued patency of the through-hole. The cut or coiled reinforcement layer of the hypotube increases axial tensile strength, preventing breakage or deformation due to excessive stretching even in the extended configuration, while maintaining the outer diameter in the expanded configuration, ensuring a secure drainage area.

[0025] In an optional embodiment, the guide tube body is divided into a guide tube body section C and a guide tube body section D from the proximal end to the distal end, and the guide tube body section D is transitionally connected with the distal head, thereby avoiding an increase in resistance of the medical device during use due to a sudden change in the cross-sectional diameter of the distal head.

[0026] In an optional embodiment, the outer diameters of the D section of the guide tube body and the distal head gradually decrease from the proximal end to the distal end, facilitating the smooth pushing and precise positioning of the medical device in the blood vessel, which not only reduces the resistance of the medical device during the pushing process, but also helps the doctor to more accurately control the position of the medical device during the operation.

[0027] In an optional embodiment, when the guide tube body is in the expanded configuration, the outer diameter of the guide tube body remains unchanged from the distal end to the proximal end.

[0028] In an optional embodiment, when the guide tube body is in the expanded configuration, the outer diameter of the guide tube body gradually increases from the distal end to the proximal end, so that the distal end of the guide tube body is not attached to the blood vessel, and blood can better enter the interior of the guide tube body from the through hole on the distal end of the guide tube body, and the proximal end of the guide tube body can be attached to the blood vessel to provide a supporting effect, thereby enabling the guide tube body to be supported in the blood vessel when in the expanded configuration, and also ensuring that the guide tube body has a better blood suction effect.

[0029] In an optional embodiment, when the guide tube body is in an expanded configuration, the outer diameter of the guide tube body first increases and then decreases from the distal end to the proximal end, and then the middle part of the guide tube body contacts the inner wall of the blood vessel, playing a supporting role. There is a gap between the outer wall of the proximal and distal ends of the guide tube body and the inner wall of the blood vessel, and the blood in the blood vessel can enter the through hole through the gap, which can ensure both the supporting effect of the guide tube body and the blood suction effect of the guide tube body.

[0030] In an optional embodiment, when the guide tube is in the expanded configuration, the outer diameter of the guide tube fluctuates from the distal end to the proximal end. Portions of the outer wall of the guide tube contact the inner wall of the blood vessel to provide support. Other portions of the outer wall of the guide tube do not contact the inner wall of the blood vessel, creating a gap between the through-hole in this portion and the inner wall of the blood vessel. This gap allows blood in the blood vessel to enter the through-hole, thereby ensuring both the support and blood-drawing effects of the guide tube.

[0031] In an optional embodiment, the material hardness of the distal head is greater than the material hardness of the guide tube body.

[0032] The beneficial effects of the above technical solution are as follows: the distal head portion added to the distal end of the medical device does not have a through-hole, and the distal head portion enhances the local material strength or structural thickness, compensating for the problem of regional weakness caused by the through-hole in the distal end of the medical device. The provision of the distal head portion enhances the structural stability of the medical device during the pushing process, preventing deformation or rupture of the medical device due to the insertion of the pushing member. When the pushing member is inserted and pushes the distal head portion, the distal head portion can withstand greater thrust, preventing the distal end of the guide tube body from rupturing due to stress concentration. This is particularly suitable for use in scenarios where blood vessels are tortuous or operational resistance is high, significantly improving the reliability and safety of the medical device.

[0033] In an optional embodiment, the distal head is divided into a distal head segment E and a distal head segment F from the distal end to the proximal end;

[0034] The distal head section E is a single-layer elastic tube, and / or the distal head section F is a multi-layer hardened tube and includes at least one third reinforcement layer.

[0035] In one optional embodiment, the combined area of ​​the through-holes on the guide tube is greater than the combined area of ​​the non-through-hole areas. Through-holes are key channels for blood drainage within the guide tube, and their area directly determines the rate at which blood flows into the lumen. When the through-hole area accounts for more than 50% of the outer surface area, more intravascular blood can quickly enter the guide tube through the through-holes, significantly increasing the drainage flow rate per unit time.

[0036] In an optional embodiment, the sum of the areas of the through holes on the guide tube body accounts for 52.5% or more of the outer surface area of ​​the guide tube body, and the non-through hole area on the guide tube body accounts for 47.5% or less of the outer surface area of ​​the guide tube body; or

[0037] The ratio of the sum of the areas of the through holes on the guide tube body to the non-through hole area on the guide tube body is greater than 1.1; or

[0038] The total area of ​​the through holes on the guide tube body accounts for 52.5% to 50% of the outer surface area of ​​the guide tube body, and the non-through hole area on the guide tube body accounts for 47.5% to 50% of the outer surface area of ​​the guide tube body.

[0039] In an optional embodiment, the diameter of each through hole on the guide tube body gradually decreases from the distal end to the proximal end along the axial direction.

[0040] The beneficial effects of this technical solution are as follows: A larger through-hole at the distal end of the guide tube increases the drainage area in this region and reduces resistance to blood flow into the lumen. The proximal end must withstand the connecting forces supporting the tube as well as external forces such as pushing, pulling, and rotation during surgical operations. The smaller through-hole diameter means a larger non-through-hole area on the proximal tube wall, improving the proximal end's resistance to stretching and compression, and preventing tube rupture due to manipulation or blood flow impact.

[0041] In an optional embodiment, the diameter of each through hole on the guide tube body first increases and then decreases from the distal end to the proximal end along the axial direction.

[0042] The beneficial effects of the above technical solution are: the small aperture at the distal end of the guide tube body prevents the tube wall from being too thin due to an excessively large aperture; the large aperture in the middle section of the guide tube body matches the high pressure in the middle section of the blood vessel, increases the drainage area, and significantly improves the blood inflow rate in this area; the small aperture at the proximal end of the guide tube body can improve the strength of the proximal end of the guide tube body.

[0043] In an optional embodiment, the diameter of each through hole on the guide tube body gradually increases from the distal end to the proximal end along the axial direction.

[0044] The beneficial effects of the above technical solution are as follows: the small aperture design at the distal end of the guide tube body reduces the drainage area, but correspondingly increases the thickness of the tube wall, thereby improving the strength of this area. This design is suitable for surgical operations that require higher strength support. The large aperture design at the proximal end facilitates the smooth flow of blood into the lumen and reduces resistance. At the same time, the larger through-hole diameter also means that the non-through-hole area of ​​the proximal tube wall is relatively small, but this can be compensated by optimizing the tube wall material or increasing the tube wall thickness to ensure that the overall strength of the proximal end meets the surgical requirements.

[0045] In an optional embodiment, the diameter of each through hole on the guide tube body first decreases and then increases from the distal end to the proximal end along the axial direction.

[0046] The beneficial effects of this technical solution are as follows: the through-holes at the distal end of the guide tube are larger, increasing the drainage area. The smaller through-holes in the middle section ensure sufficient strength in this area to withstand the various external forces during surgery. The larger through-holes at the proximal end of the guide tube optimize blood flow efficiency and reduce resistance within the lumen. This design balances the performance requirements of the guide tube in different areas, improving its overall effectiveness.

[0047] In an optional embodiment, the diameter of each through hole on the guide tube body is constant along the axial direction from the distal end to the proximal end.

[0048] The beneficial effects of the above technical solution are: not only does it simplify the production process and reduce manufacturing costs, but the constant pore size ensures a more uniform flow of blood in the lumen, avoiding turbulence or increased resistance caused by pore size changes.

[0049] In an optional embodiment, the porosity of the guide tube body decreases gradually from the distal end to the proximal end. The proximal end needs to withstand the connection force of the support tube body and external forces such as pushing, pulling, and rotation during surgical operations.

[0050] The benefits of this technical solution are as follows: low porosity means a higher proportion of non-through-hole area in the proximal tube wall, which improves its resistance to stretching and compression, preventing tube rupture due to manipulation or vascular compression. High porosity at the distal end, however, improves suction efficiency.

[0051] In an optional embodiment, the porosity of the guide tube body first increases and then decreases from the distal end to the proximal end.

[0052] The above technical solution has the following beneficial effects: the distal end of the guide tube has low porosity, which improves its structural strength and prevents it from rupturing during use. The middle section of the guide tube has high porosity, maximizing the drainage area and efficiently collecting high-velocity blood. The proximal end of the guide tube has low porosity, which improves its structural strength.

[0053] In an optional embodiment, the porosity of the guide tube gradually increases from the distal end to the proximal end, making the distal end of the guide tube more flexible and facilitating flexible operation in complex vascular environments. Furthermore, the gradually increasing porosity helps blood flow more smoothly into the guide tube, improving blood collection efficiency.

[0054] In an optional embodiment, the porosity of the guide tube decreases and then increases from the distal end to the proximal end. This design combines the advantages of the two porosity variations described above. The high porosity at the distal end of the guide tube enhances blood suction at that end. The porosity of the midsection is appropriately reduced. Although this sacrifices some drainage area, it further enhances the overall strength of the tube, ensuring stability during surgery. The proximal end of the guide tube adopts a high porosity design to facilitate smooth blood flow.

[0055] In one optional embodiment, the porosity of the guide tube is constant from distal to proximal. This means that the proportion of non-through-hole area in the guide tube wall remains consistent from distal to proximal, simplifying the production process and reducing manufacturing costs. Furthermore, this constant porosity ensures that the guide tube has relatively balanced flexibility and structural strength, making it suitable for general surgical procedures.

[0056] In an optional embodiment, when the guide tube body is in the expanded configuration, the ratio of the axial length of the guide tube body to the axial length of the support tube body is 1 to 8:1;

[0057] When the guide tube body is in the extended configuration, the ratio of the axial length of the guide tube body to the axial length of the support tube body is 2 to 25:1.

[0058] The beneficial effects of the above technical solution are: significantly increasing the axial distribution range of the through hole, and the expanded coverage reduces the need to adjust the cannula position or use multiple cannulas during surgery, thereby improving surgical efficiency and reducing the risk of patient trauma.

[0059] In an optional embodiment, when the guide tube is in the extended configuration, the total length of the medical device is 250-1000 mm, the maximum outer diameter of the medical device is between 3-13 mm, and the maximum inner diameter of the medical device is between 2-12 mm.

[0060] When the guide tube is in the expanded configuration, the total length of the medical device is 200-800 mm, the maximum outer diameter of the guide tube in the medical device is between 4-15 mm, and the maximum inner diameter of the guide tube in the medical device is between 3-14 mm.

[0061] The beneficial effects of the above technical solutions are that the maximum outer diameter of the guide tube body in the elongated configuration, for example 8mm, is smaller than the maximum outer diameter in the expanded configuration, for example 12mm, which can significantly reduce the friction area between the tube body and the blood vessel wall, especially in tortuous, narrow or fragile blood vessels, and the insertion resistance is smaller, reducing the risk of endothelial injury in the blood vessel. The total length of the medical device is 250-1000mm, which is significantly longer than the 200-800mm in the expanded configuration, which cooperates with the axial length advantage of the guide tube body to ensure that the through hole thereon covers a longer blood vessel area, directly solving the problem of insufficient drainage coverage of long lesions.

[0062] In the expanded state, the outer diameter increases significantly, which can increase the contact area between the tube body and the blood vessel wall, fix the position of the tube body through friction, and avoid displacement caused by blood flow or patient activity. Correspondingly, the inner diameter of the medical device in the expanded configuration is significantly larger than that in the elongated configuration. According to the Poiseuille law of fluid mechanics, the increase in the inner diameter can significantly increase the blood pumping flow. For example, the inner diameter of the medical device in the expanded configuration increases from 7mm to 11mm, and the flow increases several times, meeting the demand for high-flow blood drainage in extracorporeal circulation surgery.

[0063] In an optional embodiment, the ratio of the axial length of the guide tube body in the expanded configuration to the axial length of the guide tube body in the elongated configuration is 0.3-0.9; and the ratio of the outer diameter of the guide tube body in the expanded configuration to the outer diameter of the guide tube body in the elongated configuration is 1.1-1.9.

[0064] In an optional embodiment, the support tube body is divided into a first support tube body and a second support tube body, one end of the first support tube body is connected with the guide tube body, and the other end of the first support tube body is connected with the second support tube body.

[0065] The first support tube body has an elongated shape and an expanded shape; when the guide tube body is in the elongated configuration, the first support tube body is in the elongated shape; when the guide tube body is in the expanded configuration, the first support tube body is in the expanded shape, thereby enabling the support tube body to adapt to the elongation and expansion of the guide tube body.

[0066] In an optional embodiment, when the first support tube body is in the elongated shape, the outer diameter of the first support tube body gradually increases from the distal end to the proximal end, and / or the first support tube body and the guide tube body are transitionally connected, and / or the first support tube body and the second support tube body are transitionally connected.

[0067] In an optional embodiment, when the first support tube is in the expanded state, the axial length of the first support tube is 35-75 mm, and / or the outer diameter of the first support tube is 4-15 mm, and / or the wall thickness of the first support tube is 0.1-0.8 mm;

[0068] When the first support tube is in the extended state, the axial length of the first support tube is 100-140 mm, and / or the minimum outer diameter of the first support tube is 3-13 mm.

[0069] In an optional embodiment, the outer diameter of the second support tube body when the guide tube body is in the extended configuration is the same as the outer diameter of the guide tube body when the guide tube body is in the expanded configuration. The second support tube body maintains a constant outer diameter and axial length in both guide tube configurations, providing greater support strength, ensuring a stable connection with the connecting tube, and enhancing the reliability of the overall structure.

[0070] In an optional embodiment, when the first support tube body is in an elongated or expanded state, the axial length of the second support tube body is 110-160 mm; and / or, the outer diameter of the second support tube body is 4-15 mm; and / or, the wall thickness of the second support tube body is 0.14-0.84 mm.

[0071] In an optional embodiment, the axial length of the support tube body when the first support tube body is in the extended state is greater than the axial length of the first support tube body when the first support tube body is in the expanded state.

[0072] In an optional embodiment, when the first support tube is in the expanded state, the axial length of the support tube is 145-235 mm;

[0073] When the first support tube is in the extended state, the axial length of the support tube is 210-300 mm.

[0074] In an optional embodiment, the first supporting tube body includes at least one first supporting layer and at least one first cladding layer, and the first cladding layer is provided on the first supporting layer by spraying, dipping or laminating.

[0075] In an optional embodiment, the second supporting tube body includes at least one second supporting layer and at least one second cladding layer, and the second cladding layer is disposed on the second supporting layer by spraying, dipping or laminating.

[0076] In an optional embodiment, the three-point bending force of the guide tube body and the support tube body meets the following requirements:

[0077]

[0078] F2 is the three-point bending force of the support tube body; F1 is the three-point bending force of the guide tube body.

[0079] In an alternative embodiment, the area of the through hole of the guide tube body in the expanded configuration is larger than the area of the through hole of the guide tube body in the elongated configuration.

[0080] In an alternative embodiment, the outer diameter of the guide tube body at the intersection with the support tube body is different from the outer diameter of the support tube body at the intersection, and the difference between the outer diameter of the guide tube body at the intersection with the support tube body and the outer diameter of the support tube body at the intersection is not greater than 1.2 mm.

[0081] In an alternative embodiment, the difference between the outer diameter of the guide tube body at the intersection with the support tube body and the outer diameter of the support tube body at the intersection is not greater than 1 mm, for example, it can be 0.9-1 mm.

[0082] In a second aspect, the present application also provides a pushing member, which is matched with the medical member.

[0083] In an alternative embodiment, the distal end of the pushing member is provided with a pre-plastic configuration, which is a bent shape matched with the shape of the blood vessel to be inserted.

[0084] The pushing member has the beneficial effect that when the distal end of the pushing member is provided with a pre-plastic configuration, the pre-plastic design of the distal end has a bending angle, and the distal end of the pushing member is provided with a bent shape matched with the shape of the blood vessel to be inserted. During operation, the medical member can be driven to achieve the designed plastic angle, facilitating the positioning of the product.

[0085] In a third aspect, the present application also provides a guide device, comprising:

[0086] a medical member;

[0087] a pushing member, which can be inserted into the medical member and is limited by the distal end of the medical member; when the pushing member is inserted into the medical member and pushes the medical member to move distally, the medical member is converted from the expanded configuration to the elongated configuration, and when the pushing member is separated from the medical member, the medical member is converted from the elongated configuration to the expanded configuration.

[0088] The above technical solution has the beneficial effect that the pushing member is inserted into the medical member, which is elongated, and then inserted into the blood vessel, so that the positioning of the medical member can be achieved even in a tortuous blood vessel, and the positioning is very accurate. After the medical member is inserted into the blood vessel and radially expanded, the lumen of the medical member is enlarged, so that the suction flow during the operation of the medical member is large, and the lumen size can be fully utilized.

[0089] In an alternative embodiment, the guide device further comprises:

[0090] A limiting structure is arranged at the proximal end of the medical member and the proximal end of the pushing member; the limiting structure has a first position and a second position; when the limiting structure is in the first position, the pushing member is positioned inside the medical member and can be synchronously delivered; when the limiting structure is in the second position, the pushing member and the medical member are separated from each other.

[0091] In an alternative embodiment, the limiting structure comprises a connecting tube, a connecting seat and a locking member; the connecting tube is arranged at the proximal end of the guide tube of the medical member; the connecting seat is divided into a distal end part and a proximal end part, and the distal end part is connected with the pushing member; the locking member is arranged between the connecting tube and the connecting seat, and is adapted to lock the connecting tube and the connecting seat.

[0092] The beneficial effects of the above technical solution are as follows: by dividing the connecting seat into a distal end part and a proximal end part, and making the outer diameter of the distal end part smaller than the inner diameter of the through hole and the outer diameter of the proximal end part larger than the inner diameter of the through hole, it is ensured that the distal end part of the connecting seat can be smoothly inserted into the through hole when the pushing member is inserted into the medical member, and the proximal end part of the connecting seat cannot be inserted into the through hole and is located outside the connecting tube, so that when it is necessary to separate the pushing member from the medical member, the proximal end part of the connecting seat located at the tail part can be directly pulled out after the locking member is unlocked, and the separation of the whole pushing member can be easily realized without the need of additional tools or complex steps, thereby simplifying the disassembly process, making the disassembly of the pushing member more convenient and reducing the operation difficulty. On the other hand, the outer diameter of the proximal end part of the connecting seat is larger than the inner diameter of the through hole, so that the proximal end part of the connecting seat cannot be inserted into the through hole when the pushing member is inserted into the medical member, thereby playing a limiting role and avoiding the insertion of the pushing member into the medical member too deep.

[0093] In an alternative embodiment, a through hole is arranged on the connecting tube and communicates with the guide tube;

[0094] The outer diameter of the distal end part of the connecting seat gradually decreases from the proximal end to the distal end, and the maximum outer diameter of the distal end part of the connecting seat is smaller than the inner diameter of the through hole;

[0095] The locking member is an elastic stepped structure arranged at the distal end part of the connecting seat, and the maximum outer diameter of the elastic stepped structure is larger than the inner diameter of the through hole, so that the elastic stepped structure is interference-fitted with the through hole when the distal end part of the connecting seat is inserted into the through hole.

[0096] The beneficial effects of the above technical solution are as follows: when connecting the connecting tube and the connecting seat, the conical surface of the connecting seat can be directly embedded in the connecting tube, and the fit is completed by the self-tensioning force of the elastic step structure. The multiple steps of the step structure form multiple sections of contact with the inner wall of the through hole, which increases the contact area and friction, and avoids loose connections caused by vibration, liquid impact or external force. When the step structure of the elastic material is inserted into the through hole, it generates a radial rebound force due to extrusion, fits tightly to the inner wall of the through hole, and forms a self-locking effect, which can maintain the connection state without additional fasteners. The design of the elastic step structure significantly simplifies the assembly process and can be quickly connected without tools.

[0097] In an optional embodiment, the locking member includes a first connecting member and a second connecting member; the first connecting member is placed on the inner wall of the through hole; the second connecting member is arranged on the side wall of the distal end of the connecting seat and is adapted to the first connecting member; the second connecting member has at least a first position and a second position, when the second connecting member is in the first position, the second connecting member corresponds to the position of the first connecting member, and the second connecting member slides with the first connecting member, when the second connecting member is in the second position, the second connecting member is placed in the through hole and staggered with the first connecting member.

[0098] In an optional embodiment, the first connecting member includes at least one incision, and the second connecting member includes at least one protrusion. When the protrusion is in a first position, the protrusion corresponds to the position of the incision and can pass through the incision. When the protrusion is in a second position, the protrusion is placed in the through hole and staggered with the incision. The protrusion abuts against the inner side surface of the proximal wall of the connecting tube, thereby limiting the movement of the pushing member to the proximal position.

[0099] The above technical solution has the beneficial effect of locking and unlocking the connecting tube and the connecting base with a simple operation, which is very simple to operate and ensures the security of the connection. After the tube is inserted, the connecting base can be easily removed by simply adjusting the protrusion to the first position, without the need for complicated disassembly tools or steps, thus improving disassembly efficiency.

[0100] In an optional embodiment, the via hole is divided into a first via hole and a second via hole from the distal end to the proximal end, and the inner diameter of the first via hole is larger than the inner diameter of the second via hole;

[0101] The outer diameter of the distal end portion of the connection base is smaller than the inner diameter of the second through hole, so that the distal end portion of the connection base can pass through the first through hole and the second through hole;

[0102] The outer diameter of the proximal portion of the connection base is greater than the inner diameter of the second through hole, so that the proximal portion of the connection base cannot penetrate into the first through hole and the second through hole.

[0103] In an optional embodiment, when the protrusion switches from the first position to the second position, the protrusion penetrates into the first through hole along the incision and is offset from the incision after rotation;

[0104] When the protrusion switches from the second position to the first position, the protrusion rotates to a position corresponding to the incision and then passes through the incision. BRIEF DESCRIPTION OF THE DRAWINGS

[0105] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0106] Figure 1 A schematic structural diagram of the medical device provided by the present invention;

[0107] Figure 2 A schematic structural diagram of the medical device provided by the present invention;

[0108] Figure 3 For the present invention Figure 2 AA section view in the figure;

[0109] Figure 4 For the present invention Figure 2 A magnified view of part B;

[0110] Figure 5 It is a structural schematic diagram of the pushing member of the present invention;

[0111] Figure 6 This is a schematic structural diagram of the present invention when the distal end of the pushing member is set to a pre-molded configuration;

[0112] Figure 7 A schematic structural diagram of a connecting pipe in a guiding device provided in Example 4 of the present invention;

[0113] Figure 8 A side view of a connecting pipe in a guide device provided in Example 4 of the present invention;

[0114] Figure 9 A schematic diagram of the connection structure between the pushing member and the connecting seat in the guiding device provided by the present invention;

[0115] Figure 10 A schematic structural diagram of the guiding device provided by the present invention before the medical component is stretched;

[0116] Figure 11 A schematic diagram of the structure of the guiding device provided by the present invention after the medical component is stretched;

[0117] Figure 12 A schematic diagram of the connection structure between the pushing member and the connecting seat in the guiding device provided in Example 5 of the present invention;

[0118] Figure 13 This is a schematic structural diagram of the medical component in the guiding device provided in Example 5 of the present invention after being stretched;

[0119] Figure 14 A side view of a connecting pipe in a guide device provided in Example 6 of the present invention;

[0120] Figure 15 A schematic structural diagram of a pushing member in a guiding device provided in Example 6 of the present invention;

[0121] Figure 16 A schematic structural diagram of the guide device provided in Example 6 of the present invention when the pusher is connected to the connecting seat and the cutout is in the first position;

[0122] Figure 17 A schematic structural diagram of the guide device provided in Example 6 of the present invention when the pusher is connected to the connecting seat and the cutout is in the second position;

[0123] Figure 18 A side view of a connecting pipe in a guide device provided in Example 7 of the present invention;

[0124] Figure 19 A schematic structural diagram of a pushing member in a guiding device provided in Example 7 of the present invention;

[0125] Figure 20 A schematic structural diagram of the second protrusion and the second opening in the first position when the pushing member and the connecting seat are connected in the guiding device provided in Example 7 of the present invention;

[0126] Figure 21 A schematic structural diagram of the second protrusion and the second opening in the second position when the pushing member and the connecting seat are connected in the guiding device provided in Example 7 of the present invention;

[0127] Figure 22 Another structural schematic diagram of the connecting seat in the guiding device provided by the present invention;

[0128] Figure 23 A schematic structural diagram of the medical device provided by the present invention in an extended configuration;

[0129] Figure 24 A schematic diagram of the change in outer diameter of the guide tube body in the medical device provided by the present invention when the guide tube body is in an expanded configuration;

[0130] Figure 25Another schematic diagram of the change in outer diameter of the guide tube body in the medical device provided by the present invention when the guide tube body is in the expanded configuration;

[0131] Figure 26 A schematic structural diagram of the guide tube body of the medical device provided by the present invention, in which a step is formed at the intersection of the guide tube body and the support tube body when the guide tube body is in the expanded configuration;

[0132] Figure 27 A schematic structural diagram of the guide tube body of the medical device provided by the present invention, in which a step is formed at the intersection of the guide tube body and the support tube body when the guide tube body is in an extended configuration;

[0133] Figure 28 For the present invention Figure 26 and Figure 27 A partial enlarged view of part C.

[0134] Description of reference numerals:

[0135] 1. Medical component, 11. Distal head, 111. Guidewire hole, 112. Distal head segment E, 113. Distal head segment F, 12. Guide tube body, 121. Through hole, 122. Guide tube body segment C, 123. Guide tube body segment D, 13. Support tube body, 131. First reinforcement layer, 132. Support tube inner layer, 133. Support tube outer layer, 134. First support tube, 135. Second support tube, 14. Limiting step, 114. Proximal wall of the distal head;

[0136] 2. a pushing member, 21. an elastic material layer;

[0137] 3. Connecting tube, 31. Through hole, 311. First through hole, 312. Second through hole, 32. Notch, 33. Proximal end wall of connecting tube, 34. Inner surface of proximal end wall of connecting tube;

[0138] 4. Connecting seat, 41. Distal end portion of the connecting seat, 411. Elastic stepped structure, 42. Proximal end portion of the connecting seat, 421. Distal end surface of the proximal end portion of the connecting seat, 43. Protrusion, 431. Proximal end surface of the protrusion, 44. Accommodating groove, 45. First protrusion, 46. First opening, 47. Second protrusion, 48. Second opening, 49. Annular groove. DETAILED DESCRIPTION

[0139] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative efforts shall fall within the scope of protection of the present invention.

[0140] In the description of the present invention, it should be noted that, unless otherwise specified or limited, the term "distal end" generally refers to the end of a medical implant away from the operator; "proximal end," in contrast to "distal end," refers to the end of a medical implant closer to the operator; the term "distal surface" refers to the surface located at the distal end; the term "distal portion" refers to the portion located at the distal end; the term "proximal wall" refers to the side wall near the proximal end; the term "radial direction" refers to a direction perpendicular to the axis of the medical implant; and the term "axial direction" refers to a direction coaxial with the axis of the medical implant. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific circumstances.

[0141] Specific embodiments of the present invention will be described in detail below with reference to the medical component of the first aspect of the present invention, the pushing component of the second aspect of the present invention, and the guiding device of the third aspect of the present invention.

[0142] Example 1

[0143] Combine Figures 1 to 4 As shown, according to an embodiment of the present invention, in a first aspect, a medical component is provided, comprising a guide tube body 12 and a support tube body 13. A plurality of through holes 121 are provided on the side wall of the guide tube body 12. The guide tube body 12 has an elongated configuration in an elongated state and an expanded configuration in an expanded state. The axial length of the elongated configuration is greater than the axial length of the expanded configuration, and the outer diameter of the elongated configuration is smaller than the outer diameter of the expanded configuration. The support tube body 13 is coaxially connected to the proximal end of the guide tube body 12. When the guide tube body 12 is transformed from the expanded configuration to the elongated configuration, the axial length of the guide tube body 12 is elongated and the outer diameter of the guide tube body 12 is reduced; when the guide tube body 12 is transformed from the elongated configuration to the expanded configuration, the axial length of the guide tube body 12 is shortened and the outer diameter of the guide tube body 12 is increased.

[0144] In the above-mentioned medical device, the guide tube body 12 can be switched to an elongated configuration (long axial length and small outer diameter) during the insertion stage, forming a more slender shape, significantly reducing the insertion resistance, and facilitating smooth advancement to the target position (such as the right atrium or vena cava) in complex vascular pathways. The small outer diameter design of the elongated configuration can reduce the friction area and contact pressure between the guide tube body 12 and the inner wall of the blood vessel during the insertion process, avoiding damage to the vascular endothelium caused by forced pushing. After being inserted into place, the guide tube body 12 can be switched to an expanded configuration (shortened axial length and increased outer diameter), which increases the blood drainage flow by expanding the cross-sectional area of ​​the lumen, ensuring that the extracorporeal circulation system obtains sufficient hypoxic blood supply, meets the gas exchange requirements of the oxygenator, and avoids circulatory instability caused by insufficient flow.

[0145] When the guide tube body 12 is in the expanded configuration, the axial length of the through hole 121 is shorter than when the guide tube body 12 is in the extended configuration. When the guide tube body 12 is in the expanded configuration, the radial length of the through hole 121 is longer than when the guide tube body 12 is in the extended configuration. That is, when the guide tube body 12 transitions from the extended configuration to the expanded configuration, the axial length of the through hole 121 of the guide tube body 12 shortens, while the radial length of the through hole 121 of the guide tube body 12 increases. Furthermore, the increase in the radial length of the through hole 121 of the guide tube body 12 is greater than the decrease in the axial length, thereby increasing the area of ​​the through hole 121 of the guide tube body 12. This significantly improves the drainage efficiency of the guide tube body 12, optimizes the blood flow path, and reduces blood flow resistance.

[0146] The coaxial connection design between the support tube body 13 and the proximal end of the guide tube body 12 can stabilize the axial position of the guide tube body 12 and prevent displacement caused by changes in tube diameter during configuration conversion; at the same time, the dynamic switching of the two configurations can be flexibly adjusted according to the actual needs of the operation, thereby improving the controllability of the intubation operation.

[0147] The current guide tube 12 is relatively short, while the support tube 13 is relatively long, resulting in the through hole 121 only covering a local area and failing to meet the drainage requirements of a long section of blood. To address this problem, in some embodiments, the axial length of the guide tube 12 is greater than the axial length of the support tube 13.

[0148] By extending the length of the guide tube 12, the through holes 121 opened thereon cover a wider area, which can specifically solve the needs of long-distance blood drainage and improve clinical applicability. At the same time, the rigidity of the support tube 13 can help the guide tube 12 maintain its shape and enhance the reliability of the overall structure.

[0149] The guide tube 12 is designed to have two states: an extended configuration and an expanded configuration. In the extended configuration, the axial length of the guide tube 12 is longer and the outer diameter is smaller, which reduces resistance during insertion into a blood vessel (especially into tortuous vessels) and allows the pusher 2 to more smoothly push the tube to the target location. In the expanded configuration, the axial length of the guide tube 12 is shortened and the outer diameter is increased, which increases the contact area with the vessel wall, stabilizes the tube's position within the vessel, and prevents displacement. Furthermore, in the expanded state, the through-hole 121 is more stretched, improving blood pumping efficiency. Switching between these two configurations balances insertion difficulty and in-place stability, optimizing the user experience.

[0150] Furthermore, when the guide tube body 12 is in the expanded configuration, the ratio of the axial length of the guide tube body 12 to the axial length of the support tube body 13 is 1 to 8:1. When the guide tube body 12 is in the extended configuration, the ratio of the axial length of the guide tube body 12 to the axial length of the support tube body 13 is 2 to 25:1. Setting the ratio of the axial length of the guide tube body 12 to the axial length of the support tube body 13 to 1 to 8:1 significantly increases the axial distribution range of the through hole 121. For example, if the length of the support tube body 13 is 125 mm, the length of the guide tube body 12 can reach 125 to 1000 cm, and the through hole 121 thereon can cover a vascular area of ​​125 to 1000 cm, directly solving the drainage problem of long lesions. The expanded coverage reduces the need to adjust the cannula position or use multiple cannulas during surgery, thereby improving surgical efficiency and reducing the risk of patient trauma.

[0151] Because of the second reinforcement layer, guide tube 12 maintains sufficient anti-collapse capability even when its length increases to 1 to 88 times that of support tube 13. The mesh or cutout structure of the second reinforcement layer disperses external forces such as vascular compression and blood impact, preventing localized deformation or collapse of guide tube 12 due to increased length, ensuring that through-hole 121 remains open.

[0152] In some embodiments, when the guide tube 12 is in the extended configuration, the total length of the medical device is 250-1000 mm, and the maximum outer diameter of the guide tube 12 is between 3-13 mm. For example, the maximum inner diameter of the guide tube 12 is between 2-12 mm. The maximum outer diameter of the guide tube 12 can be 7 mm, and the maximum inner diameter of the guide tube 12 can be 6 mm; the maximum outer diameter of the guide tube 12 can be 8 mm, and the maximum inner diameter of the guide tube 12 can be 7 mm; the maximum outer diameter of the guide tube 12 can be 9 mm, and the maximum inner diameter of the guide tube 12 can be 8 mm.

[0153] When the guide tube 12 is in the expanded configuration, the total length of the medical device is 200-800 mm, and the maximum outer diameter of the guide tube 12 in the medical device is between 4-15 mm. For example, the maximum inner diameter of the medical device is between 3-144 mm. The maximum outer diameter of the guide tube 12 can be 11 mm, and the maximum inner diameter of the guide tube 12 can be 10 mm; the maximum outer diameter of the guide tube 12 can be 12 mm, and the maximum inner diameter of the guide tube 12 can be 11 mm; the maximum outer diameter of the guide tube 12 can be 13 mm, and the maximum inner diameter of the guide tube 12 can be 12 mm.

[0154] When the guide tube body 12 is in the extended configuration, the maximum outer diameter of the guide tube body 12 is 8 mm, and the maximum inner diameter of the guide tube body 12 is 7 mm. The maximum outer diameter of the guide tube body 12 in the extended configuration is 8 mm, which is smaller than the 12 mm in the expanded configuration. This significantly reduces the friction area between the tube body and the blood vessel wall, especially in tortuous, narrow, or fragile blood vessels, resulting in less resistance during insertion and reducing the risk of endothelial damage. The total length of the medical device is 250-1000 mm, significantly longer than the 200-800 mm in the expanded configuration. Combined with the axial length advantage of the guide tube body 12 itself, it ensures that the through hole 121 thereon covers a longer blood vessel area, directly solving the problem of insufficient drainage coverage for long-segment lesions.

[0155] When the guide tube 12 is in the expanded configuration, with a maximum outer diameter of 15 mm, the contact area between the tube and the vessel wall is increased, securing the tube's position through friction and preventing displacement due to blood flow or patient movement. The guide tube 12 has a maximum inner diameter of 14 mm, significantly larger than in the telescopic configuration. According to Poiseuille's law in fluid mechanics, an increase in inner diameter significantly increases blood flow. For example, increasing the inner diameter of a medical device from 7 mm to 11 mm can increase flow several times, meeting the high-flow blood drainage requirements required during extracorporeal circulation surgery.

[0156] As an alternative embodiment, the ratio of the axial length of the guide tube body 12 when in the expanded configuration to the axial length of the guide tube body 12 when in the extended configuration is 0.3 to 0.9; the ratio of the outer diameter of the guide tube body 12 when in the expanded configuration to the outer diameter of the guide tube body 12 when in the extended configuration is 1.1 to 1.9.

[0157] In some embodiments, because a plurality of through holes 121 are provided on the side wall of the guide tube body 12, these holes will weaken the mechanical strength of the tube body. When the length of the guide tube body 12 increases, its compressive resistance will be weakened. When the guide tube body 12 is subjected to large external forces such as blood vessel squeezing and blood impact, local deformation and mesh collapse are prone to occur, resulting in blockage of the through holes 121 or reduction of the drainage area. Therefore, the current solution sets the guide tube body 12 to be shorter or to be of the same length as the support tube body 13, but such an arrangement will cause the through holes 121 to only cover a local area and cannot meet the drainage needs of long sections of blood.

[0158] To address the mesh collapse issue when the guide tube body 12 is long and to ensure that the through-holes 121 of the guide tube body 12 can cover a wider area, in this embodiment, at least one of the guide tube body 12 and the support tube body 13 is provided with a reinforcement layer. This compensates for the structural weakening caused by the through-holes 121. Even if the axial length of the guide tube body 12 is significantly increased, for example, if the axial length of the guide tube body 12 is greater than that of the support tube body 13, its deformation resistance remains stable. This improves the long-range blood drainage coverage of the guide tube body 12 while also preventing mesh collapse.

[0159] In some embodiments, the support tube 13 is a multi-layered tube and includes at least one first reinforcement layer 131, which is a braided, coiled, or cut hypotube structure. The first reinforcement layer 131 can withstand axial compression, preventing the support tube 13 from shortening or partially collapsing due to excessive force during pushing, thereby ensuring effective transmission of the thrust to the distal guide tube 12. The braided or coiled first reinforcement layer 131 forms a grid-like support framework that disperses radial pressure generated by vascular compression, preventing compression-induced deformation of the support tube 13, which could lead to stenosis of the lumen and impair blood flow.

[0160] The support tube 13 can be configured in at least three schemes, and all of the design schemes of the support tube 13 need to ensure its airtightness so that it does not leak during operation. Specific design schemes of the support tube 13 are described in detail below.

[0161] The first design of the support tube 13: combined with Figure 3 As shown, the support tube body 13 is composed of three layers, including, from the inside to the outside, a support tube inner layer 132, a first reinforcement layer 131, and a support tube outer layer 133. The support tube inner layer 132 can be made of a polymer material (TPU, PEBAX, silicone, or other materials with equivalent performance). The first reinforcement layer 131 can be made of round wire, flat wire, or other shaped wire made of Niti or stainless steel or other materials, by weaving and winding, or can be made by cutting patterns using Niti or stainless steel sea wave tubes. The support tube outer layer 133 is made of a polymer material. In this embodiment, the design of the support tube body 13 provides the medical device with stronger connection strength and stability between the pusher 2 and the distal head 11. The polymer material of the support tube outer layer 133 has good elasticity and biocompatibility, which can ensure that the medical device does not cause additional damage to the blood vessel when inserted into the blood vessel. The reinforcement effect of the first reinforcement layer 131 enables the support tube body 13 to withstand greater external forces, preventing breakage or damage due to external forces during use. At the same time, the material and manufacturing process of the first reinforcement layer 131, such as weaving, spring winding or cutting patterns, can be adjusted according to actual needs to meet the requirements of different medical scenarios.

[0162] The wall thickness of the outer layer 133 of the support tube increases gradually from the distal end to the proximal end, or is of uniform thickness. A uniform thickness of the outer layer 133 of the support tube facilitates processing and production. The wall thickness of the outer layer 133 of the support tube increases gradually from the distal end to the proximal end, significantly improving the compressive strength of the proximal end. Because the proximal end typically bears greater external forces (e.g., during connections and fixation), the increased wall thickness can better resist external pressure and prevent the tube from rupturing or deforming.

[0163] The second design of the support tube body 13: Traditional multi-layer tubes are prone to peeling when pushed or subjected to force due to insufficient interlayer interface bonding, resulting in structural failure. The support tube body 13 of this embodiment includes a support tube inner layer tube 132 and a first reinforcement layer 131. The support tube inner layer tube 132 and the first reinforcement layer 131 are arranged in sequence from the inside to the outside. The first reinforcement layer 131 has multiple first reinforcement layer gaps. The support tube inner layer tube 132 fills the first reinforcement layer gaps from the inside to the outside and diffuses to the outer surface of the first reinforcement layer 131 or does not diffuse to the outer surface of the first reinforcement layer 131. When the support tube inner layer tube 132 fills the first reinforcement layer gaps from the inside to the outside and diffuses to the outer surface of the first reinforcement layer 131, the interlayer interface is further eliminated, forming a continuous structure of inner layer tube-reinforcement layer-outer layer, avoiding the risk of delamination; if it does not diffuse, the inner layer material filling the gaps can also fix the first reinforcement layer 131 through physical interlocking to prevent it from shifting or loosening. After the gaps in first reinforcement layer 131 are filled with the inner tube material, the supporting elements of first reinforcement layer 131 are connected together by the inner material. During pushing, axial thrust is evenly transmitted through the inner material to first reinforcement layer 131, preventing fracture or deformation caused by localized stress concentration. The filled inner material cushions the deformation of first reinforcement layer 131 under radial pressure, while first reinforcement layer 131 provides rigid support for the inner tube. Together, these two enhance the compressive strength of the supporting tube.

[0164] The wall thickness of the inner layer 132 of the support tube can be uniform or gradually increase from the distal end to the proximal end. A uniform wall thickness of the inner layer 132 of the support tube facilitates processing and production. The wall thickness of the inner layer 132 of the support tube gradually increases from the distal end to the proximal end. This design significantly improves the compressive strength of the proximal end. Because the proximal end typically bears greater external forces (e.g., during connections and fixation), the increased wall thickness can better withstand external pressure and prevent the tube from rupturing or deforming.

[0165] The third design scheme of the support tube body 13: Traditional multi-layer tubes are prone to peeling when pushed or subjected to force due to insufficient inter-layer interface bonding strength, resulting in structural failure. The support tube body 13 of this embodiment includes a first reinforcement layer 131 and a support tube body outer layer tube 133. The first reinforcement layer 131 and the support tube body outer layer tube 133 are arranged in sequence from the inside to the outside. The first reinforcement layer 131 has multiple first reinforcement layer gaps. The support tube body outer layer tube 133 fills the first reinforcement layer gaps from the outside to the inside and diffuses to the inner surface of the first reinforcement layer 131 or does not diffuse to the inner surface of the first reinforcement layer 131. During the molding process, the outer layer tube material will flow and fill the gaps in the first reinforcement layer 131, forming a physical fit between the outer layer material and the reinforcement layer gaps, so that the outer layer tube is tightly combined with the first reinforcement layer 131, avoiding delamination caused by pushing force or blood vessel compression. If the outer tube material diffuses onto the inner surface of the first reinforcement layer 131, it forms a continuous outer tube-first reinforcement layer-inner layer structure, eliminating the interlayer interface. If it does not diffuse, the outer layer material filling the gaps still secures the reinforcement layer by interlocking, preventing it from shifting or loosening. After the gaps in the first reinforcement layer 131 are filled with the outer tube material, the support unit is connected to the outer layer material to form a single unit. During pushing, axial thrust can be evenly transmitted through the outer layer material to the reinforcement layer, preventing localized stress concentration that could cause fracture or deformation of the reinforcement layer.

[0166] The wall thickness of the outer layer tube 133 of the support tube body can be uniform or gradually thickened from the distal end to the proximal end.

[0167] In some embodiments, a large number of through holes 121 are provided at the distal end of the medical component. The area near the through holes 121 becomes weak due to the openings and easily becomes the starting point of rupture. In scenarios where the blood vessels are tortuous or the operating resistance is large, the distal end of the medical component 1 is easily ruptured during the process of the pusher 2 being inserted into the interior of the medical component 1 and pushing the medical component 1 toward the distal pusher 2. In order to solve this problem, the guide tube body 12 of this embodiment includes a guide tube body and a distal head 11. The distal head 11 is provided at the distal end of the guide tube body, and the material hardness of the distal head 11 is greater than the material hardness of the guide tube body. The distal head 11 is suitable for abutting against the pusher 2 inserted into the inner cavity of the guide tube body, and drives the guide tube body and the support tube 13 to move under the push of the pusher 2.

[0168] The material of the distal head 11 can be TPU, PEBAX, nylon, silicone, etc. of different hardness. The selection of these materials can be adjusted according to the requirements of the actual application scene. TPU has excellent elasticity and can withstand a large pushing force without deforming; PEBAX combines elasticity and toughness, suitable for use in complex vascular environments; nylon material has high strength, suitable for occasions that require high hardness and support force; and silicone material is soft and biocompatible, suitable for direct contact with human tissues. By selecting the appropriate material for the distal head 11, the guide device can effectively transfer force during the pushing process and reduce damage to the blood vessel wall, improving the safety and success rate of the operation.

[0169] In this embodiment, the distal head 11 added at the distal end of the medical member does not have a through hole 121, and the local material strength or structural thickness is enhanced by the distal head 11, which makes up for the problem of weak area caused by the through hole 121 at the distal end of the medical member. The setting of the distal head 11 enhances the structural stability of the medical member 1 during the pushing process, preventing deformation or rupture of the medical member 1 due to the insertion of the pushing member 2. When the pushing member 2 is inserted and pushes the distal head 11, the distal head 11 can withstand a larger pushing force, avoiding rupture of the distal end of the guide tube body due to stress concentration, especially suitable for scenes with tortuous blood vessels or large operating resistance, greatly improving the reliability and safety of the medical member 1. The design of the distal head 11 directly abutting the pushing member 2 allows the pushing force to be transmitted to the entire medical member 1 through the more rigid distal head 11, rather than relying solely on the flexible tube wall at the distal end, reducing the deformation or wrinkling of the medical member 1 during the pushing process, ensuring that the tube body advances stably along the blood vessel path, thereby reducing frictional damage to the inner wall of the blood vessel, and allowing the medical member 1 to be inserted into place. By reducing the risk of rupture of the medical member 1 and the possibility of damage to the blood vessel, this embodiment directly reduces the incidence of intraoperative complications, shortens the operation time, reduces the physiological burden on the patient, and improves postoperative recovery.

[0170] Further, the distal head 11 has a certain length in the axial direction, for example, the axial length of the distal head 11 is set to 10-30 mm, so that the distal head 11 can effectively increase the hardness of the distal end of the guide tube body and improve the anti-rupture performance, without reducing the flexibility of the medical member 1 during use due to the excessive length of the distal head 11.

[0171] In some embodiments, the distal head 11 has a proximal wall 114 of the distal head, which is adapted to abut the pushing member 2 and can form a stable and efficient mechanical contact surface with the pushing member 2, allowing the medical member 1 to move more smoothly to the target position under the action of the pushing member 2.

[0172] The proximal wall 114 of the distal head is a plane perpendicular to the central axis of the lumen. The distal surface of the pusher 2 is a plane perpendicular to the central axis of the lumen. Consequently, when the pusher 2 pushes the medical device 1 to extend, the medical device 1 can extend completely along its axis, thereby ensuring the accuracy and stability of the pushing process and preventing possible deviation or distortion of the medical device 1 during the pushing process. Furthermore, the proximal wall 114 of the distal head contacts the plane of the distal surface of the pusher 2, increasing the contact area and dispersing the pushing force, further reducing the risk of rupture of the distal end of the medical device 1 during the pushing process.

[0173] In some embodiments, the central axis of the guidewire hole 111 is parallel to the central axis of the lumen. More specifically, the central axis of the guidewire hole 111 is collinear with the central axis of the lumen, which can ensure that the guidewire can be smoothly inserted into the guidewire hole 111 along the lumen.

[0174] In some embodiments, the guide tube body includes a second reinforcement layer, which is a braided member, a coiled member, or a hypotube cutting member. In this embodiment, the braided or coiled reinforcement layer (such as nickel-titanium alloy wire braiding) can form a grid-like support skeleton to disperse the radial pressure generated by blood vessel compression, prevent the guide tube body 12 from collapsing due to excessive local force, and ensure that the through hole 121 remains open. The hypotube cutting or coiling reinforcement layer can increase the axial tensile strength, and even if the guide tube body 12 is in an elongated configuration, it can avoid breakage or deformation caused by excessive stretching, while maintaining the outer diameter shape in the expanded configuration to ensure the drainage area.

[0175] The guide tube body is divided into a guide tube body C section 122 and a guide tube body D section 123 from the proximal end to the distal end. The guide tube body D section 123 is transitionally connected with the distal head 11, avoiding an increase in resistance of the medical device 1 during use due to a sudden change in the cross-sectional diameter of the distal head 11.

[0176] The outer diameter of the guide tube body D section 123 and the distal head 11 gradually decreases from the proximal end to the distal end, which facilitates the smooth pushing and precise positioning of the medical device 1 in the blood vessel. It not only reduces the resistance of the medical device 1 during the pushing process, but also helps the doctor to control the position of the medical device 1 more accurately during the operation.

[0177] The connection between the distal surface of the distal head 11 and the side wall is set as an arc-shaped transition section, so that the distal end of the distal head 11 is a rounded head end, thereby avoiding scratching the blood vessel when contacting the inner wall of the blood vessel.

[0178] The guide tube body is comprised of a coiled component, a mesh braided component, a tubular cutting component, or a carved component. The coiled component is a metal coiled tube with excellent elasticity and plasticity, capable of adapting to various blood vessel shapes. The mesh braided component is woven from nickel-titanium alloy wire or a biocompatible material, forming a tubular structure with multiple through-holes 121. The tubular cutting component can be created by cutting a pattern into a NiTi or stainless steel hypotube. The carved component uses precision engraving technology to carve tiny through-holes 121 into the surface of the guide tube body.

[0179] The guide tube body is an elastic and retractable component. When the pusher 2 is in contact with the distal head 11, the axial length of the guide tube body is extended, and the radial length of the guide tube body is shortened; when the pusher 2 is out of contact with the distal head 11, the axial length of the guide tube body is shortened, and the radial length of the guide tube body is extended. In this embodiment, the medical component 1 can more flexibly adapt to the shape of the blood vessel during the pushing process, reducing the resistance and damage to the blood vessel during pushing. At the same time, after the pusher 2 is out of contact with the distal head 11, the guide tube body can return to its original state, maintain a stable support effect, and ensure the accuracy and safety of the medical operation.

[0180] In some embodiments, the outer diameter of the distal head 11 gradually decreases from the proximal end to the distal end. More specifically, the distal head 11 is configured to be conical.

[0181] Currently, in order to insert the medical device 1 into a blood vessel, a pusher 2 needs to extend from the distal end of the medical device 1. The distal end of the pusher 2 is often configured in a pointed cone shape. When the pusher 2 and the medical device 1 move within the blood vessel, the distal end of the pusher 2 may scratch the blood vessel. In some embodiments, the distal head 11 is divided from the distal end to the proximal end into a distal head segment E 112 and a distal head segment F 113. The distal head segment E 112 and the distal head segment F 113 are provided with a guidewire hole 111, which allows a guidewire to pass therethrough. The inner diameter of the guide tube body segment D 123 is larger than the inner diameter of the guidewire hole 111, so that a limiting step 14 is formed between the guide tube body segment D 123 and the distal head segment F 113. The outer diameter of the distal end of the pusher 2 is larger than the inner diameter of the guidewire hole 111, and smaller than the inner diameter of the guide tube body D section 123. Consequently, when the pusher 2 is inserted into the interior of the medical device 1, it is restrained by the stop step 14. In this embodiment, the distal end of the pusher 2 mates with the stop step 14 within the medical device 1, stretching the medical device 1. This embodiment completely incorporates the distal end of the pusher 2 within the medical device 1, thus avoiding the situation where the distal end of the pusher 2 is configured as a pointed cone, thereby preventing the entire device from damaging the blood vessel during insertion.

[0182] Furthermore, the limiting step 14 is a plane perpendicular to the axis of the medical device 1, and the distal end surface of the pusher 2 is a plane perpendicular to the axis of the pusher 2. Thus, when the pusher 2 pushes the medical device 1 to extend, the medical device 1 can extend completely along its axis. Alternatively, the limiting step 14 is a concave surface, with a shape that matches the distal end of the pusher 2.

[0183] The through-holes 121 currently provided on the medical device 1 are relatively small, resulting in low blood flow and velocity, making it impossible to fully utilize the lumen of the medical device 1. Furthermore, when the tube body adheres to the wall during operation, the side wall through-holes 121 are blocked, affecting the suction efficiency. To address this issue, in some embodiments, the distal head segment F 113 and the guide tube body 12 are provided with a metal reinforcement layer, and the through-holes 121 are provided on the distal head segment F 113. The metal reinforcement layer of the distal head segment F 113 and the guide tube body 12 is a wound component, a mesh woven component, a tubular cut component, or a carved component, thereby enlarging the formed through-holes 121. Even if the tube body adheres to the blood vessel, a blood flow gap will still exist between the through-holes 121 and the blood vessel wall, thereby ensuring blood suction efficiency.

[0184] In some embodiments, the distal head section E 112 is a single-layer elastic tube. The distal head section E 112 is configured to be elastic. The distal head section E 112 is made of a polymer material and has a through hole 121 to prevent scratches on blood vessels. The distal head section F 113 is a multi-layer hardened tube and includes at least one third reinforcement layer to prevent deformation after the pusher 2 is inserted, which may affect its normal use. In a specific embodiment, the distal head section F 113 can be a three-layer tube, which, from the inside to the outside, comprises an inner polymer layer, a metal reinforcement layer, and an outer polymer layer. The inner polymer layer can be filled with a polymer material or an injection molded part.

[0185] As a specific embodiment, the distal head F segment 113 can be a three-layer tube, consisting of, from the inside out, an inner polymer layer, a third reinforcement layer, and an outer polymer layer. The inner polymer layer can be filled with a polymer material or an injection molded part. The third reinforcement layer is a metal reinforcement layer, which has excellent mechanical properties and stability, effectively enhancing the overall strength and rigidity of the distal head F segment 113 and preventing deformation or damage due to external forces during use. The outer polymer layer provides a certain degree of elasticity and flexibility, allowing the medical device 1 to be inserted into a blood vessel more smoothly and reducing damage to the blood vessel.

[0186] In the aforementioned medical device 1, the first, second, and third reinforcement layers are all metal reinforcement layers, and they are integrated into a single unit, eliminating any interlayer interfaces. This prevents the risk of fracture caused by stress concentration at the joints when separate components are installed. The integrated molding of the first, second, and third reinforcement layers reduces the number of component assembly steps and reduces process complexity.

[0187] In addition, the first, second, and third reinforcement layers can be arranged separately and set to different strengths. The first reinforcement layer 131 can be designed as a highly rigid structure to accommodate the needs of pushing over long distances or through tortuous blood vessels. The second reinforcement layer can be designed as a flexible mesh structure, enhancing collapse resistance while retaining a certain degree of radial expandability to ensure full expansion of the through-holes 121. The third reinforcement layer can be designed as a locally hardened structure to enhance the compression resistance of the contact area with the pusher 2, thereby preventing deformation of the head due to excessive thrust.

[0188] In some embodiments, combined Figure 1 As shown, when the guide tube body 12 is in the expanded configuration, the outer diameter of the guide tube body 12 remains constant from the distal end to the proximal end. Preferably, the outer diameter of the guide tube body C segment 122 remains constant from the distal end to the proximal end, so that the guide tube body C segment 122 adheres to the inner wall of the blood vessel.

[0189] As an alternative embodiment, in combination with Figure 24 As shown, when the guide tube body 12 is in the expanded configuration, the outer diameter of the guide tube body 12 gradually increases from the distal end to the proximal end. Preferably, the outer diameter of the guide tube body C segment 122 gradually increases from the distal end to the proximal end, so that the distal end of the guide tube body C segment 122 does not adhere to the blood vessel, allowing blood to better enter the guide tube body 12 through the through hole 121 on the distal end of the guide tube body C segment 122. The proximal end of the guide tube body C segment 122 can adhere to the blood vessel to provide support, thereby enabling the guide tube body 12 to be supported within the blood vessel when in the expanded configuration, while also ensuring that the guide tube body 12 has a good blood aspiration effect.

[0190] As an alternative embodiment, in combination with Figure 25 As shown, the outer wall of the guide tube body 12 fluctuates from the distal end to the proximal end. Preferably, the outer diameter of the guide tube body C segment 122 fluctuates from the distal end to the proximal end. Part of the outer wall of the guide tube body C segment 122 contacts the inner wall of the blood vessel to provide support. The remaining outer wall of the guide tube body C segment 122 does not contact the inner wall of the blood vessel, so that a gap exists between the through hole 121 in this portion and the inner wall of the blood vessel, ensuring that blood in the blood vessel can enter the through hole 121 through this gap, thereby ensuring both the support effect of the guide tube body 12 and the blood suction effect of the guide tube body 12.

[0191] As an alternative embodiment, the outer diameter of the guide tube body 12 increases first and then decreases from the distal end to the proximal end. Preferably, the outer diameter of the guide tube body C segment 122 increases first and then decreases from the distal end to the proximal end, so that the middle portion of the guide tube body C segment 122 contacts the inner wall of the blood vessel, providing support. A gap exists between the outer walls of the proximal and distal ends of the guide tube body C segment 122 and the inner wall of the blood vessel, allowing blood in the blood vessel to enter the through-hole 121 through the gap, thereby ensuring both the support effect of the guide tube body 12 and the blood suction effect of the guide tube body 12.

[0192] In some embodiments, the radial support force of the guide tube 12 is 15-45 N when its diameter is 7-9 mm after compression. After compression to the minimum diameter, the guide tube 12 naturally rebounds to a diameter of 7-9 mm. The chronic outward force is 2-15 N. When the average compression along the diameter is 5 mm, the force range is 5-15 N. After the guide tube 12 is compressed to the minimum diameter, it naturally rebounds with a slow external force of 2-15 N. This avoids the impact of sudden rebound on the inner wall of the blood vessel, allowing the guide tube 12 to gradually conform to the blood vessel wall, reducing mechanical stimulation to fragile blood vessels and improving intubation safety.

[0193] In some embodiments, combined Figure 23 As shown, the support tube 13 is divided into a first support tube 134 and a second support tube 135. One end of the first support tube 134 is connected to the guide tube 12, and the other end of the first support tube 134 is connected to the second support tube 135. The first support tube 134 has an extended state and an expanded state. When the guide tube 12 is in the extended configuration, the first support tube 134 is in the extended state; when the guide tube 12 is in the expanded configuration, the first support tube 134 is in the expanded state, thereby enabling the support tube 13 to adapt to the extension and expansion of the guide tube 12.

[0194] The diameter of the second support tube 135 when the guide tube 12 is in the extended configuration is the same as the diameter when the guide tube 12 is in the expanded configuration. The second support tube 135 maintains a constant diameter and axial length in both configurations of the guide tube 12, providing greater support strength, ensuring a stable connection with the connecting tube 3, and enhancing the reliability of the overall structure.

[0195] When the first support tube 134 is in the extended configuration, the diameter of the first support tube 134 gradually increases from the distal end to the proximal end, thereby preventing a sudden change in the shape between the guide tube 12 and the second support tube 135 when the guide tube 12 is in the extended configuration. Preferably, when the first support tube 134 is in the extended configuration, the first support tube 134 is configured to be conical.

[0196] The transition between the first support tube 134 and the guide tube 12 makes the junction between the two more rounded and less likely to damage blood vessels. The transition between the first support tube 134 and the second support tube 135 makes the junction between the two more rounded and less likely to damage blood vessels.

[0197] When the first support tube 134 is in the expanded configuration, the axial length of the first support tube 134 is 35-75 mm, preferably 45-65 mm. The diameter of the first support tube 134 is 4-15 mm, preferably 8-10 mm. The wall thickness of the first support tube 134 is 0.1-0.8 mm, preferably 0.3-0.5 mm. In other words, the axial length of the first support tube 134 can be 35 mm, 45 mm, 55 mm, 65 mm, or 75 mm. Preferably, the axial length of the first support tube 134 is 55 mm. The diameter of the first support tube 134 can be 4 mm, 8 mm, 9 mm, 10 mm, or 15 mm. Preferably, the diameter of the first support tube 134 is 10 mm. The wall thickness of the first support tube body 134 can be 0.1 mm, 0.3 mm, 0.4 mm, 0.5 mm, or 0.8 mm. Preferably, the wall thickness of the first support tube body 134 is 0.4 mm.

[0198] When the first support tube 134 is in the extended state, the axial length of the first support tube 134 is 100-140 mm, preferably 110-130 mm. The minimum diameter of the first support tube 134 is 3-13 mm, preferably 4.5-5 mm. In other words, the axial length of the first support tube 134 can be 100 mm, 110 mm, 120 mm, 130 mm, or 140 mm. Preferably, the axial length of the first support tube 134 is 120 mm. The minimum diameter of the first support tube 134 can be 3 mm, 4.5 mm, 4.8 mm, 5 mm, or 13 mm. Preferably, the minimum diameter of the first support tube 134 is 4.8 mm.

[0199] When the first support tube 134 is in the extended or expanded configuration, the axial length of the second support tube 135 is 110-160 mm, preferably 120-150 mm. Specifically, the axial length of the second support tube 135 can be 110 mm, 120 mm, 130 mm, 140 mm, 150 mm, or 160 mm. The diameter of the second support tube 135 is 4-15 mm, preferably 8-10 mm. Specifically, the diameter of the second support tube 135 can be 4 mm, 8 mm, 9 mm, 10 mm, or 15 mm. Preferably, the diameter of the second support tube 135 is 10 mm. The wall thickness of the second support tube body 135 is 0.14-0.84 mm, and the wall thickness of the second support tube body 135 is preferably 0.34-0.54 mm, that is, the wall thickness of the second support tube body 135 can be 0.14 mm, 0.34 mm, 0.44 mm, 0.54 mm, or 0.84 mm. Preferably, the wall thickness of the second support tube body 135 is 0.44 mm.

[0200] The axial length of the support tube 13 when the first support tube 134 is in the extended state is greater than the axial length when the first support tube 134 is in the expanded state. When the first support tube 134 is in the expanded state, the axial length of the support tube 13 is 145-235 mm, preferably 165-215 mm. In other words, the axial length of the support tube 13 in this state can be 145 mm, 165 mm, 175 mm, 200 mm, 215 mm, or 235 mm. When the first support tube 134 is in the extended state, the axial length of the support tube 13 is 210-300 mm, preferably 230-280 mm. In other words, the axial length of the support tube 13 in this state can be 210 mm, 230 mm, 240 mm, 250 mm, 260 mm, 270 mm, 280 mm, or 300 mm.

[0201] The first support tube 134 includes at least one first support layer and at least one first cladding layer. The first cladding layer is applied to the first support layer by spraying, dipping, or laminating. The first support layer is connected to the reinforcement layer of the guide tube 12. The second support tube 135 includes at least one second support layer and at least one second cladding layer. The second cladding layer is applied to the second support layer by spraying, dipping, or laminating. The second support layer is connected to the first support layer.

[0202] As a preferred embodiment, the first support tube body 134 is a double-layer tube body including a first support layer and a first cladding layer, and the second support tube body 135 is a three-layer tube body including a first support layer and two first cladding layers.

[0203] When both the first support tube 134 and the guide tube 12 are extended, the wall thickness of the first support tube 134 is greater than the wall thickness of the guide tube 12. For example, when the wall thickness of the first support tube 134 is 0.4 mm, the wall thickness of the guide tube 12 is 0.36 mm.

[0204] In some embodiments, the three-point bending force of the guide tube 12 and the support tube 13 meets the following requirements:

[0205]

[0206] Wherein: F2 is the three-point bending force of the supporting tube body 13; F1 is the three-point bending force of the guiding tube body 12.

[0207] The guide tube body 12 and the support tube body 13 are coaxially connected at the proximal end and need to bear the bending load together during the surgical operation. If the difference in bending force between the two is too large, the connection interface is prone to stress concentration due to stiffness mismatch, and long-term use may cause the interface to tear or break. The above formula shows that the bending strength of the two is similar, and the deformation is coordinated when subjected to force, which reduces local stress and prolongs the service life. The above formula enables the guide tube body 12 and the support tube body 13 to jointly maintain the tube shape when bending, which not only avoids bends but also ensures the configuration conversion capability of the guide tube body 12.

[0208] In some embodiments, the combined area of ​​the through-holes 121 on the guide tube body 12 is greater than the combined area of ​​the non-through-hole regions of the guide tube body 12. Through-holes 121 are key channels for blood drainage through the guide tube body 12, and their area directly determines the rate at which blood flows into the lumen. When the area of ​​through-holes 121 accounts for more than 50% of the outer surface area, more intravascular blood can quickly enter the guide tube body 12 through through-holes 121, significantly increasing the drainage flow rate per unit time.

[0209] More specifically, the sum of the areas of the through holes 121 on the guide tube body 12 accounts for 52.5% or more of the outer surface area of ​​the guide tube body 12 , and the non-through hole area on the guide tube body 12 accounts for 47.5% or less of the outer surface area of ​​the guide tube body 12 .

[0210] As an alternative embodiment, the ratio of the sum of the areas of the through holes 121 on the guide tube body 12 to the non-through hole area on the guide tube body 12 is greater than 1.1.

[0211] As an alternative embodiment, the sum of the areas of the through holes 121 on the guide tube body 12 accounts for 52.5% to 50% of the outer surface area of ​​the guide tube body 12 , and the non-through hole area on the guide tube body 12 accounts for 47.5% to 50% of the outer surface area of ​​the guide tube body 12 .

[0212] In some embodiments, the aperture of each through hole 121 on the guide tube body 12 gradually decreases axially from the distal end to the proximal end. The design of a through hole 121 with a larger aperture at the distal end of the guide tube body 12 can increase the drainage area of ​​this area and reduce the resistance of blood flowing into the lumen. The proximal end needs to withstand the connection force of the support tube body 13 and external forces such as pushing, pulling, and rotation during surgical operations. A smaller through hole diameter means a larger non-through hole area of ​​the proximal tube wall, which can improve the proximal end's resistance to stretching and extrusion, and avoid tube rupture caused by operation or blood flow impact.

[0213] As an alternative embodiment, the diameter of each through hole 121 in the guide tube body 12 increases and then decreases axially from the distal end to the proximal end. The small diameter at the distal end of the guide tube body 12 prevents the tube wall from being too thin due to an excessively large diameter. The large diameter in the middle section of the guide tube body 12 matches the high pressure in the middle section of the blood vessel, increases the drainage area, and significantly improves the blood flow rate in this area. The small diameter at the proximal end of the guide tube body 12 can improve the strength of the proximal end of the guide tube body 12.

[0214] As an alternative embodiment, the aperture of each through hole 121 on the guide tube body 12 gradually increases axially from the distal end to the proximal end. Although the small aperture design at the distal end of the guide tube body 12 reduces the drainage area, it correspondingly increases the thickness of the tube wall and improves the strength of this area. This design is suitable for surgical operations that require higher strength support. The large aperture design at the proximal end is conducive to the smooth flow of blood into the lumen and reduces resistance. At the same time, the larger through hole aperture also means that the non-through hole area of ​​the proximal tube wall is relatively small, but this can be compensated by optimizing the tube wall material or increasing the tube wall thickness to ensure that the overall strength of the proximal end meets the surgical requirements.

[0215] As an alternative embodiment, the aperture of each through hole 121 on the guide tube body 12 first decreases and then increases from the distal end to the proximal end along the axial direction. The through hole aperture at the distal end of the guide tube body 12 is larger, which increases the drainage area. The middle section adopts a smaller through hole aperture to ensure that the tube body has sufficient strength in this area to withstand various external forces during the operation. The proximal end of the guide tube body 12 adopts a larger through hole aperture to optimize the blood inflow efficiency and reduce the resistance in the lumen. This design takes into account the performance requirements of the guide tube body 12 in different areas and improves its overall use effect.

[0216] As an alternative embodiment, the diameter of each through hole in the guide tube body 12 is constant along the axial direction from the distal end to the proximal end. This not only simplifies the production process and reduces manufacturing costs, but also ensures more uniform blood flow within the lumen, avoiding turbulence or increased resistance caused by varying hole diameters.

[0217] In some embodiments, the porosity of the guide tube 12 decreases gradually from the distal end to the proximal end. The proximal end must withstand the connection forces of the support tube 13 as well as external forces such as pushing, pulling, and rotation during surgical operations. Low porosity means a higher proportion of non-through-hole area in the proximal tube wall, improving its resistance to stretching and compression, and preventing tube rupture due to manipulation or vascular compression. High porosity at the distal end, however, can enhance suction effectiveness.

[0218] As an alternative embodiment, the porosity of the guide tube body 12 increases and then decreases from the distal end to the proximal end. The low porosity at the distal end of the guide tube body 12 improves its structural strength and prevents rupture during use. The high porosity in the middle section of the guide tube body 12 maximizes the drainage area and efficiently collects high-velocity blood. The low porosity at the proximal end of the guide tube body 12 improves its structural strength.

[0219] As an alternative embodiment, the porosity of the guide tube 12 gradually increases from the distal end to the proximal end, making the distal end of the guide tube 12 more flexible and facilitating flexible operation in complex vascular environments. Furthermore, the gradually increasing porosity helps blood flow more smoothly into the guide tube 12, improving blood collection efficiency.

[0220] As an alternative embodiment, the porosity of the guide tube body 12 decreases and then increases from the distal end to the proximal end. This design combines the advantages of the two aforementioned porosity variations. The high porosity at the distal end of the guide tube body 12 enhances the blood suction capacity of the distal end of the guide tube body 12. The porosity of the middle section is appropriately reduced. Although this sacrifices some drainage area, it further improves the overall strength of the tube body and ensures stability during surgery. The proximal end of the guide tube body 12 adopts a high porosity design to facilitate smooth blood flow.

[0221] As an alternative embodiment, the porosity of the guide tube body 12 is constant from the distal end to the proximal end. This means that the proportion of non-through-hole area in the guide tube body 12 remains consistent from the distal end to the proximal end, simplifying the production process and reducing manufacturing costs. Furthermore, this constant porosity ensures that the guide tube body 12 has relatively balanced flexibility and structural strength overall, making it suitable for general surgical procedures.

[0222] In some embodiments, the outer diameters of the guide tube body 12 and the support tube body 13 at the intersection of the two are different, that is, the outer diameter of the guide tube body 12 near the support tube body 13 is different from the outer diameter of the support tube body 13 near the guide tube body 12. The intersection of the guide tube body 12 and the support tube body 13 is stepped. Figures 26 to 28As shown. The outer diameter difference at the intersection of the guide tube body 12 and the support tube body 13 is no more than 1.2mm, so that the surface lines between the guide tube body 12 and the support tube body 13 are smoother, which is conducive to puncture. The outer diameter difference at the intersection of the guide tube body 12 and the support tube body 13 can be 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm. Preferably, the outer diameter difference at the intersection of the guide tube body 12 and the support tube body 13 is 0.9-1mm. Preferably, the outer diameter difference at the intersection of the guide tube body 12 and the support tube body 13 does not exceed 1mm, for example, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm. More preferably, the difference in outer diameters of the guide tube body 12 and the support tube body 13 at the intersection thereof does not exceed 0.1 mm, but is not limited thereto.

[0223] The guide tube body 12 and the support tube body 13 can be smoothly transitioned and connected at the intersection thereof, and a certain step can also be provided at the intersection thereof.

[0224] Example 2

[0225] Combine Figure 5 As shown, according to an embodiment of the present invention, in a second aspect, a pusher 2 is provided, which is adapted to the medical device 1. The pusher 2 is mainly made of polymer material or metal tube or composite tube, and has a shape of a constant diameter through hole or a variable diameter through hole.

[0226] The pushing member 2 is configured as a straight tube configuration, and the distal wall of the pushing member 2 is configured as a plane and perpendicular to its central axis. The proximal wall 114 of the distal head is a plane perpendicular to the central axis of the lumen. Therefore, when the pushing member 2 pushes the medical component 1 to extend, the medical component 1 can be completely extended along its axis, thereby ensuring the accuracy and stability of the pushing process and avoiding possible deviation or distortion of the medical component 1 during the pushing process. In addition, the proximal wall 114 of the distal head contacts the plane of the distal surface of the pushing member, which increases the contact area, disperses the pushing force, and further reduces the risk of rupture of the distal end of the medical component 1 during the pushing process.

[0227] When the pusher 2 is inserted into the medical device 1, if the insertion speed or force of the pusher 2 is too high, the distal end of the pusher 2 may break. To address this problem, the distal end wall of the pusher 2 in this embodiment is provided with an elastic material layer 21. The elastic material layer 21 can be made of silicone, rubber, or other soft materials with similar properties. The elastic material layer 21 has a certain degree of softness and elasticity. The elastic material layer 21 can act as a buffer, reducing the impact force caused by the pusher 2 on the medical device 1 when inserted, further reducing the risk of the medical device 1 breaking during the pushing process.

[0228] Example 3

[0229] Combine Figure 6 As shown, according to an embodiment of the present invention, a pushing member is provided. The difference between this embodiment and Example 2 is that the distal end of the pushing member 2 of this embodiment is set to a pre-molded configuration. When the distal end of the pushing member 2 is set to a pre-molded configuration, the pre-plastic designed distal end is designed with a bending angle, and the distal end of the pushing member 2 is set to a bending shape that matches the shape of the blood vessel to be inserted. During operation, the pushing member 2 can drive the medical device 1 to achieve the designed shaping angle, making it easier for the product to be put into place. The pushing member itself has a smaller diameter and a smaller contact area with the blood vessel wall. Combined with the fit of the pre-molded bend, the friction resistance during insertion is further reduced, making it easier for the medical device 1 to be put into place in a tortuous blood vessel.

[0230] Example 4

[0231] Combine Figures 1 to 11 As shown, according to an embodiment of the present invention, in a third aspect, a guiding device is provided. The guiding device is a blood guiding device used in an extracorporeal circulation system to establish a temporary extracorporeal circulation path in specific surgical scenarios. The guiding device includes a medical component 1, a pushing component 2, and a limiting structure.

[0232] The pusher 2 can be inserted into the interior of the medical device 1 and is limited by the distal end of the medical device 1. The medical device 1 is a tube of variable diameter that can be stretched axially. After the stretching force is removed, the medical device 1 can rebound to its original size. The medical device 1 has an elongated configuration that stretches in the axial direction and an expanded configuration that expands in the radial direction. The elongated configuration of the medical device 1 is as follows: Figure 11 As shown, the expanded configuration of the medical component 1 is as follows Figure 1 As shown. The pushing member 2 can be inserted into the medical member 1 from the proximal end of the medical member 1. When the medical member 1 is in the extended configuration, the pushing member 2 is inserted into the medical member 1 and the two are locked by the limiting structure. When the medical member 1 is in the expanded configuration, the pushing member 2 is pulled out from the medical member 1. When the pushing member 2 is inserted into the medical member 1, the pushing member 2 drives the medical member 1 to extend axially, and the medical member 1 is converted from the expanded configuration to the extended configuration. When the pushing member 2 is pulled out from the medical member 1, the medical member 1 is converted from the extended configuration to the expanded configuration.

[0233] The limiting structure is provided at the proximal end of the medical component 1 and the proximal end of the pushing component 2. The limiting structure has a first position and a second position. When the limiting structure is in the first position, the pushing component 2 is positioned inside the medical component 1 and can be synchronously transported. When the limiting structure is in the second position, the pushing component 2 and the medical component 1 are separated from each other.

[0234] In this embodiment, a pusher 2 is inserted into the medical device 1, causing it to stretch before being inserted into the blood vessel. This allows for precise positioning of the medical device 1, even in tortuous vessels. Because the medical device 1 radially expands after insertion, the lumen of the device 1 is enlarged, resulting in a greater suction flow rate during operation and fully utilizing the lumen size.

[0235] More specifically, the axial length of the extended configuration is greater than that of the expanded configuration, and the outer diameter of the extended configuration is smaller than that of the expanded configuration. In the extended configuration, the medical device 1 has a relatively long axial length, allowing it to extend more effectively within the blood vessel. Simultaneously, the smaller outer diameter of the extended configuration facilitates passage through narrowed blood vessels, minimizing damage to the patient's vessel wall. When the medical device 1 is in the expanded configuration, its outer diameter increases, correspondingly widening the lumen and thereby increasing suction flow.

[0236] In some embodiments, the outer diameter of the proximal wall 114 of the distal head of the medical device 1 is no less than the outer diameter of the pusher 2. The outer diameter of the pusher 2 is greater than the inner diameter of the guidewire hole 111. When the pusher 2 is inserted into the interior of the medical device 1, the distal end of the pusher 2 does not extend out of the medical device 1. Therefore, during use, the pusher 2 does not cause additional damage to the patient's tissue, thereby improving the safety and reliability of the surgery. Combined with the rounded distal end of the distal head 11, when the medical device 1 moves within the blood vessel, only the rounded tip contacts the blood vessel wall, reducing the risk of damage to the blood vessel wall by the medical device 1.

[0237] Currently, when the pusher 2 drives the medical device 1 to the target location, an end cap is installed at the proximal end of the medical device 1 to ensure that the distal end of the medical device 1 is always in contact with the pusher 2, thereby confining the pusher 1 within the end cap. However, because the outer diameter of the pusher 2 is comparable to the inner diameter of the medical device 1, it is very inconvenient to remove the end cap to extract the pusher 1.

[0238] To solve this problem, in some embodiments, the limiting structure includes a connecting tube 3, a connecting seat 4, and a locking member. The connecting tube 3 is arranged at the proximal end of the medical component 1, and a through hole 31 is provided on the connecting tube 3 to communicate with the medical component 1. The connecting seat 4 is divided into a connecting seat distal end 41 and a connecting seat proximal end 42. The connecting seat distal end 41 is connected to the proximal end of the push member 2. The outer diameter of the connecting seat distal end 41 is smaller than the inner diameter of the through hole 31, and the outer diameter of the connecting seat proximal end 42 is larger than the inner diameter of the through hole 31. The connecting seat distal end 41 and the proximal end of the push member 2 can be connected by gluing, or other connection methods can be used.

[0239] The locking member is disposed between the connecting tube 3 and the connecting seat 4. After the pusher 2 is inserted into the medical device 1 and moves axially toward the distal end of the medical device 1, the distal end 41 of the connecting seat is inserted into the through hole 31, and the locking member locks the connecting tube 3 and the connecting seat 4. The locking member is disposed between the connecting tube 3 and the connecting seat 4, locking them together during insertion to prevent accidental detachment. During the intubation process, the locking member connects the connecting tube 3 to the connecting seat 4, effectively pushing the medical device 1 to the target position while ensuring that the distal end of the medical device 1 is always abutted by the pusher 2, improving its positioning accuracy and avoiding deviation or jamming caused by the soft texture of the medical device 1.

[0240] In this embodiment, the connector 4 is divided into a distal portion 41 and a proximal portion 42, and the outer diameter of the distal portion 41 is smaller than the inner diameter of the through hole 31, while the outer diameter of the proximal portion 42 is larger than the inner diameter of the through hole 31. This ensures that when the pusher 2 is inserted into the medical device 1, the distal portion 41 can be smoothly inserted into the through hole 31, while the proximal portion 42 cannot be inserted into the through hole 31 and is located outside the connecting tube 3. Therefore, when the pusher 2 needs to be removed from the medical device 1, the locking member can be unlocked and the proximal portion 42 of the connector at the rear can be directly pulled out to easily remove the pusher 2 as a whole. No additional tools or complicated steps are required, simplifying the disassembly process, making the disassembly of the pusher 2 more convenient and reducing the difficulty of operation. On the other hand, the outer diameter of the proximal portion 42 of the connector is larger than the inner diameter of the through hole 31, so that when the pusher 2 is inserted into the medical device 1, the proximal portion 42 of the connector will not be inserted into the through hole 31, thereby acting as a limiter and preventing the pusher 2 from being inserted too deeply into the medical device 1.

[0241] In some embodiments, combined Figure 7As shown, the through hole 31 is divided into a first through hole 311 and a second through hole 312 from the distal end to the proximal end. The inner diameter of the first through hole 311 is larger than the inner diameter of the second through hole 312. The second through hole 312 is provided on the proximal wall 33 of the connecting tube. The outer diameter of the distal end portion 41 of the connecting base is smaller than the inner diameter of the second through hole 312, so that the distal end portion 41 of the connecting base can pass through the first through hole 311 and the second through hole 312. The outer diameter of the proximal end portion 42 of the connecting base is larger than the inner diameter of the second through hole 312, so that the proximal end portion 42 of the connecting base cannot pass through the first through hole 311 and the second through hole 312, thereby limiting the insertion of the push member 2 into the medical device 1.

[0242] In some embodiments, the locking member includes a first connector and a second connector. The first connector is disposed on the inner wall of the through hole 31. The second connector is disposed on the sidewall of the distal end portion 41 of the connector base and is adapted to mate with the first connector. The second connector has at least a first position and a second position. When the second connector is in the first position, the second connector corresponds to the position of the first connector and the second connector and the first connector are slidably engaged. When the second connector is in the second position, the second connector is positioned within the through hole 31 and offset from the first connector.

[0243] More specifically, combined with Figure 8 As shown, the first connecting member includes at least one incision 32, which is provided on the inner wall of the second through hole 312. The second connecting member includes at least one protrusion 43, which is provided on the side wall of the distal end portion 41 of the connecting seat and is adapted to the incision 32. The protrusion 43 has at least a first position and a second position. When the protrusion 43 is in the first position, the protrusion 43 corresponds to the position of the incision 32 and can pass through the incision 32, so that the distal end portion 41 of the connecting seat can be smoothly inserted into or pulled out of the connecting tube 3. When the protrusion 43 is in the second position, the protrusion 43 is placed in the first through hole 311 and is staggered with the incision 32. At this time, the protrusion 43 abuts against the inner side surface 34 of the proximal wall of the connecting tube, thereby limiting the movement of the push member 2 to the proximal position.

[0244] When the protrusion 43 switches from the first position to the second position, the protrusion 43 penetrates into the first through hole 311 along the incision 32 and is offset from the incision 32 after rotation. At this time, the locking member is in a locked state. When the protrusion 43 switches from the second position to the first position, the protrusion 43 rotates to a position corresponding to the incision 32 and then passes through the incision 32. At this time, the locking member is in an unlocked state. In this embodiment, the connecting tube 3 and the connecting seat 4 can be locked and unlocked by a simple operation. The operation is very simple and ensures the firmness of the connection. After the insertion is completed, the connecting seat 4 can be easily pulled out by simply adjusting the protrusion 43 to the first position. No complicated disassembly tools or steps are required, which improves the disassembly efficiency.

[0245] More specifically, the connecting tube 3 can be made of silicone or other elastomers, with a closed end at the proximal end. The incision 32 can be in the shape of a rectangular incision, a polygonal incision, or the like.

[0246] In some embodiments, combined Figure 10 As shown, a receiving groove 44 is formed between the proximal end surface 431 of the protrusion, the side wall surface of the distal end portion 41 of the connection seat, and the distal end surface 421 of the proximal end portion of the connection seat. The side wall surface of the distal end portion 41 of the connection seat is the side wall surface of the distal end portion 41 of the connection seat between the protrusion 43 and the proximal end portion 42 of the connection seat. When the protrusion 43 is in the second position, the proximal end wall 33 of the connecting tube is accommodated in the receiving groove 44.

[0247] If only one protrusion 43 is arranged along the axial direction of the distal end portion 41 of the connection seat, when the protrusion 43 is inserted into the position of the incision 32 and is misaligned with the incision 32, the length of the pusher 2 extending into the medical device 1 is limited. When the extension length of the medical device 1 needs to be changed, a pusher 2 of another length needs to be replaced. In order to make one pusher 2 meet the various extension requirements of the medical device 1, in some embodiments, the pusher 2 is combined with the pusher 2 to extend the medical device 1. Figure 22 As shown, a plurality of protrusions 43 are arranged at intervals along the axial direction of the distal end portion 41 of the connection seat, and the axial distance between two adjacent protrusions 43 along the axial direction is greater than the axial length of the second through hole 312 .

[0248] Because there are multiple protrusions 43 arranged at axial intervals along the distal end portion 41 of the connecting seat, each protrusion 43 is located on the same axis. When one of the protrusions 43 is aligned with the cutout 32, the remaining protrusions coaxial with the protrusion 43 will also be aligned with the cutout 32.

[0249] In this embodiment, multiple protrusions 43 allow the pusher 2 to be locked in different positions, thereby achieving multi-level adjustment of the extension length of the medical device 1. By selecting different protrusions 43 to mate with the incision 32, the user can precisely control the insertion depth of the pusher 2 to meet different clinical needs. By adjusting the position of the protrusions 43, various extension requirements can be achieved without replacing the pusher, simplifying the operation process and improving surgical efficiency.

[0250] The working process of the above-mentioned guiding device is as follows:

[0251] Before work (i.e. before stretching), combine Figure 10 As shown, the medical part 1 and the pushing part 2 are separate components.

[0252] When working, combine Figure 11As shown, the pusher 2 is inserted into the medical device 1, with the distal end of the pusher 2 abutting against the stop step 14, aligning the axes of the pusher 2 and the medical device 1. The connector 4 is pushed, pushing the medical device 1 distally, stretching the entire device 1, reducing its overall outer diameter, and placing it firmly against the pusher 2. The protrusion 43 enters the first through-hole 311 from the position of the notch 32. The connector 4 is rotated, driving the pusher 2 and the protrusion 43 to rotate, dislocating the protrusion 43 from the notch 32, thereby achieving a locked connection between the pusher 2 and the medical device 1. A guidewire is inserted into the device, and the device is delivered to the target location via the guidewire.

[0253] After reaching the target area, the connector 4 is rotated so that the protrusion 43 aligns with the incision 32. The pusher 2 is removed, and the medical device 1 rebounds to its original size. The proximal end of the medical device 1 is connected to the extracorporeal circulation device and operates in conjunction with the proximal extracorporeal circulation device. Once completed, the medical device 1 is completely removed from the human body.

[0254] Example 5

[0255] Combine Figures 12 to 13 As shown, based on Example 4, the present invention provides a guiding device. The difference between this embodiment and Example 4 is that the specific structure of the locking member of the limiting structure is different.

[0256] In this embodiment, the outer diameter of the distal portion 41 of the connection seat gradually decreases from the proximal end to the distal end, and the maximum outer diameter of the distal portion 41 of the connection seat is smaller than the inner diameter of the through hole 31 .

[0257] The locking element is a resilient stepped structure 411 disposed on the distal end 41 of the connector. The maximum outer diameter of the resilient stepped structure 411 is larger than the inner diameter of the through hole 31, ensuring an interference fit between the resilient stepped structure 411 and the through hole 31 when the distal end 41 is inserted into the through hole 31. When connecting the connecting tube 3 and the connector 4, the conical surface of the connector 4 can be directly inserted into the connecting tube 3, with the tension of the resilient stepped structure 411 completing the engagement.

[0258] The multiple steps of the stepped structure create multiple contact areas with the inner wall of via 31, increasing the contact area and friction, preventing loosening due to vibration, liquid impact, or external forces. The elastic material of the stepped structure generates a radial rebound force when inserted into via 31, tightly fitting the inner wall of via 31 and creating a self-locking effect, maintaining the connection without the need for additional fasteners.

[0259] Traditional connection methods (such as threaded tightening and snap locking) require additional operating steps or tools, while the design of the elastic step structure 411 significantly simplifies the assembly process: tool-free quick connection, only need to align the distal end 41 of the connecting seat with the through hole 31, and apply axial thrust to complete the insertion. The elastic step structure 411 enters the through hole 31 through its own deformation, and then rebounds and tightens. The entire process does not require tools such as screwdrivers and wrenches, saving surgical time; the insertion force of the elastic step structure 411 is uniform and controllable, and the doctor or nurse can complete the assembly of the connecting seat 4 and the connecting tube 3 with one hand, and the other hand can assist in fixing other instruments, thereby improving the convenience of intraoperative operations; there is no need for complicated alignment or tightening steps, reducing connection failures caused by operational errors and improving surgical safety.

[0260] Example 6

[0261] Combine Figures 14 to 17 As shown, based on Example 4, the present invention provides a guiding device. The difference between this embodiment and Example 4 is that the specific structures of the first connecting member and the second connecting member in the limiting structure are different from those in Example 4.

[0262] In this embodiment, the first connecting member includes at least one protrusion 43, and the second connecting member includes an annular groove 49 and at least one incision 32. The annular groove 49 is located at the proximal end of the incision 32 and is connected to the incision 32. When the incision 32 is in the first position, the protrusion 43 corresponds to the position of the incision 32 and can pass through the incision 32. When the incision 32 is in the second position, the protrusion 43 is placed in the annular groove 49 and is staggered with the incision 32.

[0263] In this embodiment, the connecting tube 3 and the connecting base 4 can be locked and unlocked with a simple operation, which is very simple and ensures the security of the connection. After the insertion is completed, the connecting base 4 can be easily removed by simply adjusting the notch 32 to the second position, without the need for complicated disassembly tools or steps, thus improving disassembly efficiency.

[0264] Example 7

[0265] Combine Figures 18 to 21 As shown, based on Example 4, the present invention provides a guiding device. The difference between this embodiment and Example 4 is that the specific structures of the first connecting member and the second connecting member in the limiting structure are different from those in Example 1.

[0266] In this embodiment, the first connecting member includes at least one first protrusion 45 and at least one first opening 46, and the second connecting member includes an annular groove 49, at least one second protrusion 47 and at least one second opening 48. The annular groove 49 is located proximal to the second protrusion 47 and the second opening 48, and the annular groove 49 is connected to the second opening 48.

[0267] When the second protrusion 47 and the second opening 48 are in the first position, the first protrusion 45 corresponds to the second opening 48 and can pass through the second opening 48 , and the second protrusion 47 corresponds to the first opening 46 and can pass through the first opening 46 .

[0268] When the second protrusion 47 and the second opening 48 are in the second position, the second protrusion 47 is disposed in the through hole 31 and staggered with the first opening 46 , and the first protrusion 45 is disposed in the annular groove 49 and staggered with the second opening 48 .

[0269] The retaining structure in this embodiment achieves locking and unlocking functions between the connecting tube 3 and the connecting base 4 through the interaction of the first protrusion 45, the first opening 46, the second protrusion 47, and the second opening 48. To lock the connecting tube 3 and the connecting base 4, simply pass the first protrusion 45 through the second opening 48 and the second protrusion 47 through the first opening 46 to achieve initial locking. Subsequently, by adjusting the position of the second protrusion 47 and the second opening 48 to the second position, the locking can be further strengthened, preventing the connecting tube 3 from accidentally falling off.

[0270] Furthermore, the retaining structure of this embodiment is simple in structure and easy to operate. The user does not need to use complicated disassembly tools or procedures. Simply adjusting the position of the second protrusion 47 and the second opening 48 allows the connecting tube 3 and the connecting base 4 to be unlocked and disassembled, greatly improving efficiency.

[0271] Although the embodiments of the present invention have been described with reference to the accompanying drawings, those skilled in the art may make various modifications and variations without departing from the spirit and scope of the present invention. Such modifications and variations are all within the scope defined by the appended claims.

Claims

1. A medical device, characterized in that: include: The guide tube body (12) has a plurality of through holes on its side wall. The guide tube body (12) has an elongated configuration in an elongated state and an expanded configuration in an expanded state. The axial length of the elongated configuration is greater than the axial length of the expanded configuration, and the outer diameter of the elongated configuration is smaller than the outer diameter of the expanded configuration. When the guide tube body (12) is converted from the expanded configuration to the elongated configuration, the axial length of the guide tube body (12) is elongated and the outer diameter of the guide tube body (12) is reduced. When the guide tube body (12) is converted from the elongated configuration to the expanded configuration, the axial length of the guide tube body (12) is shortened and the outer diameter of the guide tube body (12) is increased. The supporting tube body (13) is connected to the proximal end of the guiding tube body (12).

2. The medical component according to claim 1, wherein: The axial length of the guide tube body (12) is greater than the axial length of the support tube body (13).

3. The medical component according to claim 2, wherein: At least one of the guide tube body (12) and the support tube body (13) is a tube body having a reinforcement layer.

4. The medical component according to claim 3, characterized in that The support tube body (13) is a multi-layer tube and comprises at least one first reinforcement layer (131), wherein the first reinforcement layer (131) is a braided component, a wound component, or a hypotube cutting component.

5. The medical component according to claim 4, characterized in that The support tube body (13) comprises a support tube body inner layer tube (132), a first reinforcement layer (131) and a support tube body outer layer tube (133); the support tube body inner layer tube (132), the first reinforcement layer (131) and the support tube body outer layer tube (133) are arranged in sequence from the inside to the outside; and the wall thickness of the support tube body outer layer tube (133) gradually increases from the distal end to the proximal end or has a constant thickness; and / or The support tube body (13) comprises a support tube body inner layer tube (132) and a first reinforcement layer (131); the support tube body inner layer tube (132) and the first reinforcement layer (131) are arranged in sequence from the inside to the outside; the first reinforcement layer (131) has a plurality of first reinforcement layer gaps; the support tube body inner layer tube (132) fills the first reinforcement layer gaps from the inside to the outside and diffuses to the outer surface of the first reinforcement layer (131) or does not diffuse to the outer surface of the first reinforcement layer (131); and / or The support tube body (13) comprises a first reinforcement layer (131) and a support tube outer layer tube (133); the first reinforcement layer (131) and the support tube outer layer tube (133) are arranged in sequence from the inside to the outside; the first reinforcement layer (131) has a plurality of first reinforcement layer gaps; the support tube outer layer tube (133) fills the first reinforcement layer gaps from the outside to the inside and diffuses to the inner surface of the first reinforcement layer (131) or does not diffuse to the inner surface of the first reinforcement layer (131).

6. The medical component according to claim 3, characterized in that The guide tube body (12) comprises: The guide tube body has an inner cavity; The distal head (11) is arranged at the distal end of the guide tube body and connected to the guide tube body. The distal head (11) is suitable for abutting against a pushing member (2) inserted into the inner cavity of the guide tube body, and drives the guide tube body and the support tube body (13) to move under the push of the pushing member (2).

7. The medical device according to claim 6, characterized in that The guide tube body includes a second reinforcement layer, which is a braided component, a wound component, or a hypotube cutting component.

8. The medical device according to claim 6, characterized in that The guide tube body is divided into a guide tube body C section (122) and a guide tube body D section (123) from the proximal end to the distal end, and the guide tube body D section (123) is transitionally connected with the distal head (11).

9. The medical component according to claim 8, characterized in that The outer diameters of the guide tube body D section (123) and the distal head (11) gradually decrease from the proximal end to the distal end.

10. The medical device according to claim 6, wherein: The material hardness of the distal head (11) is greater than the material hardness of the guide tube body.

11. The medical device according to claim 10, characterized in that The distal head (11) is divided into a distal head section E (112) and a distal head section F (113) from the distal end to the proximal end; The distal head section E (112) is a single-layer elastic tube, and / or the distal head section F (113) is a multi-layer hardened tube and includes at least one third reinforcement layer.

12. The medical device according to claim 1, wherein When the guide tube body (12) is in the expanded configuration, the outer diameter of the guide tube body (12) remains constant from the distal end to the proximal end, or When the guide tube body (12) is in the expanded configuration, the outer diameter of the guide tube body (12) gradually increases from the distal end to the proximal end, or When the guide tube body (12) is in the expanded configuration, the outer diameter of the guide tube body (12) first increases and then decreases from the distal end to the proximal end, or When the guide tube body (12) is in the expanded configuration, the outer diameter of the guide tube body (12) is in a fluctuating shape from the distal end to the proximal end.

13. The medical component according to any one of claims 1 to 12, characterized in that: The sum of the areas of the through holes on the guide tube body (12) is not less than the sum of the areas of the non-through hole regions on the guide tube body (12).

14. The medical device according to claim 13, wherein: The sum of the areas of the through holes on the guide tube body (12) accounts for 52.5% or more of the outer surface area of ​​the guide tube body (12), and the non-through hole area on the guide tube body (12) accounts for 47.5% or less of the outer surface area of ​​the guide tube body (12); or The ratio of the sum of the areas of the through holes on the guide tube body (12) to the non-through hole area on the guide tube body (12) is greater than 1.1; or The sum of the areas of the through holes on the guide tube body (12) accounts for 52.5% to 50% of the outer surface area of ​​the guide tube body (12), and the non-through hole area on the guide tube body (12) accounts for 47.5% to 50% of the outer surface area of ​​the guide tube body (12).

15. The medical component according to any one of claims 1 to 12, characterized in that: The diameter of each through hole on the guide tube body (12) gradually decreases from the distal end to the proximal end along the axial direction; or The diameter of each through hole on the guide tube body (12) first increases and then decreases from the distal end to the proximal end along the axial direction; The diameter of each through hole on the guide tube body (12) gradually increases from the distal end to the proximal end along the axial direction; or The diameter of each through hole on the guide tube body (12) first decreases and then increases from the distal end to the proximal end along the axial direction; or The aperture of each through hole on the guide tube body (12) is constant along the axial direction from the distal end to the proximal end.

16. The medical component according to any one of claims 1 to 12, characterized in that: The porosity of the guide tube body (12) gradually decreases from the distal end to the proximal end; or The porosity of the guide tube body (12) first increases and then decreases from the distal end to the proximal end; or The porosity of the guide tube body (12) gradually increases from the distal end to the proximal end; or The porosity of the guide tube body (12) first decreases and then increases from the distal end to the proximal end; or The porosity of the guide tube body (12) is constant from the distal end to the proximal end.

17. The medical component according to any one of claims 1 to 12, characterized in that: When the guide tube body (12) is in the expanded configuration, the ratio of the axial length of the guide tube body (12) to the axial length of the support tube body (13) is 1 to 8:1; When the guide tube body (12) is in an extended configuration, the ratio of the axial length of the guide tube body (12) to the axial length of the support tube body (13) is 2 to 25:

1.

18. The medical component according to any one of claims 1 to 12, characterized in that: When the guide tube body is in the extended configuration, the total length of the medical device is 250-1000 mm, and the maximum outer diameter of the guide tube body (12) is between 3-13 mm; When the guide tube body is in the expanded configuration, the total length of the medical component is 200-800 mm, and the maximum outer diameter of the guide tube body (12) is 4-15 mm.

19. The medical component according to any one of claims 1 to 12, characterized in that: The ratio of the axial length of the guide tube body (12) when in the expanded configuration to the axial length of the guide tube body (12) when in the extended configuration is 0.3 to 0.9; the ratio of the outer diameter of the guide tube body (12) when in the expanded configuration to the outer diameter of the guide tube body (12) when in the extended configuration is 1.1 to 1.

9.

20. The medical component according to any one of claims 1 to 12, characterized in that: The support tube body (13) is divided into a first support tube body (134) and a second support tube body (135); one end of the first support tube body (134) is connected to the guide tube body (12), and the other end of the first support tube body (134) is connected to the second support tube body (135); The first support tube body (134) has an elongated form and an expanded form; when the guide tube body (12) is in the elongated configuration, the first support tube body (134) is in the elongated form; when the guide tube body (12) is in the expanded configuration, the first support tube body (134) is in the expanded form.

21. The medical device according to claim 20, characterized in that When the first support tube body (134) is in an extended state, the outer diameter of the first support tube body (134) gradually increases from the distal end to the proximal end, and / or the first support tube body (134) and the guide tube body (12) are transitionally connected, and / or the first support tube body (134) and the second support tube body (135) are transitionally connected.

22. The medical device according to claim 20, wherein: When the first support tube (134) is in an expanded state, the axial length of the first support tube (134) is 35-75 mm, and / or the outer diameter of the first support tube (134) is 4-15 mm, and / or the wall thickness of the first support tube (134) is 0.1-0.8 mm; When the first support tube (134) is in an extended state, the axial length of the first support tube (134) is 100-140 mm, and / or the minimum outer diameter of the first support tube (134) is 3-13 mm.

23. The medical device according to claim 20, wherein: The outer diameter of the second support tube (135) when the guide tube (12) is in the extended configuration is the same as the outer diameter of the guide tube (12) when the guide tube (12) is in the expanded configuration.

24. The medical device according to claim 21, wherein When the first support tube body (134) is in an elongated state or an expanded state, the axial length of the second support tube body (135) is 110-160 mm, and / or the outer diameter of the second support tube body (135) is 4-15 mm, and / or the wall thickness of the second support tube body (135) is 0.14-0.84 mm.

25. The medical device according to claim 20, wherein The axial length of the support tube (13) when the first support tube (134) is in an elongated state is greater than the axial length of the first support tube (134) when the first support tube (134) is in an expanded state.

26. The medical device according to claim 25, characterized in that When the first support tube (134) is in an expanded state, the axial length of the support tube (13) is 145-235 mm; When the first support tube (134) is in an extended state, the axial length of the support tube (13) is 210-300 mm.

27. The medical device according to claim 20, wherein The first supporting tube body (134) comprises at least one first supporting layer and at least one first cladding layer, and the first cladding layer is arranged on the first supporting layer by spraying, dipping or laminating.

28. The medical device according to claim 20, wherein The second supporting tube body (135) comprises at least one second supporting layer and at least one second cladding layer, and the second cladding layer is arranged on the second supporting layer by spraying, dipping or laminating.

29. The medical device according to any one of claims 1 to 12, characterized in that The three-point bending force of the guide tube body (12) and the support tube body (13) meets the following requirements: Wherein: F2 is the three-point bending force of the supporting tube body (13); F1 is the three-point bending force of the guiding tube body (12).

30. The medical device according to any one of claims 1 to 12, characterized in that The through-hole area of ​​the guide tube body (12) when it is in the expanded configuration is greater than the through-hole area of ​​the guide tube body (12) when it is in the extended configuration.

31. The medical device according to any one of claims 1 to 12, characterized in that The outer diameters of the guide tube body (12) and the support tube body (13) at the intersection thereof are different, and the difference in the outer diameters of the guide tube body (12) and the support tube body (13) at the intersection thereof is no greater than 1.2 mm.

32. The medical device according to claim 31, wherein The difference in outer diameter between the guide tube body (12) and the support tube body (13) at the intersection thereof is no greater than 1 mm.

33. A pushing member, characterized in that: The pushing member (2) is compatible with the medical member (1) according to any one of claims 1 to 32.

34. The pushing member according to claim 33, characterized in that The distal end of the pushing member (2) is arranged in a pre-shaped configuration, and the pre-shaped configuration is a bent shape adapted to the shape of the blood vessel to be inserted.

35. A guiding device, characterized in that: include: The medical device (1) according to any one of claims 1 to 32 ； The pushing member (2) described in claim 33 or 34 is capable of being inserted into the interior of the medical member (1) and being limited by the distal end of the medical member (1); when the pushing member (2) is inserted into the interior of the medical member (1) and pushes the medical member (1) to move distally, the medical member (1) is converted from an expanded configuration to an extended configuration, and when the pushing member (2) is separated from the interior of the medical member (1), the medical member (1) is converted from an extended configuration to an expanded configuration.

36. The guiding device according to claim 35, characterized in that The guiding device further comprises: A limiting structure is provided at the proximal end of the medical component (1) and the proximal end of the pushing component (2); the limiting structure has a first position and a second position. When the limiting structure is in the first position, the pushing component (2) is positioned inside the medical component (1) and can be transported synchronously. When the limiting structure is in the second position, the pushing component (2) and the medical component (1) are separated from each other.

37. The guiding device according to claim 36, characterized in that The limiting structure comprises a connecting tube (3), a connecting seat (4) and a locking member; the connecting tube (3) is arranged at the proximal end of the guide tube body (12) of the medical device (1); the connecting seat (4) is divided into a connecting seat distal end portion (41) and a connecting seat proximal end portion (42), and the connecting seat distal end portion (41) is connected to the pushing member (2); the locking member is arranged between the connecting tube (3) and the connecting seat (4), and the locking member is suitable for locking the connecting tube (3) and the connecting seat (4).

38. The guiding device according to claim 37, characterized in that The connecting pipe (3) is provided with a through hole (31) communicating with the guide pipe body (12); The outer diameter of the distal end portion (41) of the connection seat gradually decreases from the proximal end to the distal end, and the maximum outer diameter of the distal end portion (41) of the connection seat is smaller than the inner diameter of the through hole (31); The locking member is an elastic step structure (411) provided at the distal end portion (41) of the connection seat, wherein the maximum outer diameter of the elastic step structure (411) is greater than the inner diameter of the through hole (31), so that when the distal end portion (41) of the connection seat is inserted into the through hole (31), the elastic step structure (411) and the through hole (31) are interference-fitted.

39. The guiding device according to claim 37, characterized in that The locking member includes a first connecting member and a second connecting member; the first connecting member is placed on the inner wall of the through hole (31); the second connecting member is arranged on the side wall of the distal end portion (41) of the connecting seat and is adapted to the first connecting member; the second connecting member has at least a first position and a second position, when the second connecting member is in the first position, the second connecting member corresponds to the position of the first connecting member, and the second connecting member and the first connecting member are slidably matched, when the second connecting member is in the second position, the second connecting member is placed in the through hole (31) and is staggered with the first connecting member.

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