Developing enhanced dual-lumen microcatheter

Abstract

The utility model provides a kind of developing enhanced double-lumen microcatheter, including first tube body, second tube body and for positioning developing part;It has the proximal end of operation with the approach of operator and the distal end of operation with the distance of operator;First tube body includes forming first inner layer of first guide wire inner cavity and the first outer layer located in the outside of first inner layer;Second tube body includes forming second inner layer of second guide wire inner cavity and the second outer layer located in the outside of second inner layer;Developing part includes developing resin piece and developing metal piece;Wherein, the first outer layer located in distal end and / or the second outer layer located in distal end is developing resin piece;Developing metal piece is set to the distal end of double-lumen microcatheter and is configured to the inside, surface or interlayer of first outer layer and / or second outer layer.According to the utility model, a kind of developing enhanced double-lumen microcatheter can be provided, which is beneficial to realize the accurate positioning of double-lumen microcatheter or guide wire.

Description

Technical Field

[0001] This utility model relates to the field of biomedical engineering industry, specifically to a contrast-enhanced dual-lumen microcatheter. Background Technology

[0002] In interventional medicine, microcatheters, as precision delivery devices, are widely used in cardiovascular and neurointerventional medical applications. Their core function is to precisely deliver embolic materials, drugs, and other therapeutic devices or reagents to the target lesion site through natural cavities such as blood vessels, enabling minimally invasive diagnosis and treatment. For example, in percutaneous coronary intervention (PCI), microcatheters are often used in chronic total occlusion (CTO) lesions to assist guide wires in reaching the proximal end of calcified or tortuous vessels and even traversing the lesion site.

[0003] As interventional techniques evolve towards "high precision and low invasiveness," clinicians are placing higher demands on the functional integration, operational flexibility, and adaptability of microcatheters. Single-lumen microcatheters are increasingly unable to meet the needs of complex diagnostic and treatment scenarios. Compared to single-lumen microcatheters, dual-lumen microcatheters, due to their dual-lumen characteristics, can simultaneously accommodate two guidewires and provide strong "back-to-back" support, giving them unique advantages in severely calcified, long lesions, bifurcation lesions, and even tortuous vessels. For example, dual-lumen microcatheters have significant advantages in applications such as access to side branches, side branch ancher technology, parallel wire, reverse wire, and stent-cross techniques.

[0004] However, existing dual-lumen microcatheters have insufficient X-ray visibility, which may affect the accuracy of the procedure. Utility Model Content

[0005] This invention was made in view of the above-mentioned state of the prior art, and its purpose is to provide a contrast-enhanced dual-lumen microcatheter, which is beneficial for achieving precise positioning of catheters and / or guidewires.

[0006] Therefore, this utility model provides a contrast-enhanced dual-lumen microcatheter, which includes a first tube body, a second tube body, and a contrast-enhancing section for positioning; the contrast-enhanced dual-lumen microcatheter has a proximal end that is close to the operator during operation and a distal end that is far from the operator during operation; the first tube body has a first guidewire lumen that slidably receives a guidewire, and the first tube body includes a first inner layer forming the first guidewire lumen and a first outer layer located outside the first inner layer; the second tube body has a second guidewire lumen that slidably receives a guidewire, and the second tube body includes a second inner layer forming the second guidewire lumen and a second outer layer located outside the second inner layer; the contrast-enhancing section includes a contrast-enhancing resin element and a contrast-enhancing metal element; wherein, the first outer layer located at the distal end and / or the second outer layer located at the distal end are the contrast-enhancing resin elements; the contrast-enhancing metal element is disposed at the distal end of the contrast-enhanced dual-lumen microcatheter and is configured inside, on the surface, or between the layers of the first outer layer and / or the second outer layer.

[0007] In the dual-lumen microcatheter of this invention, the guidewire can move through the first guidewire lumen of the first tube and also through the second guidewire lumen of the second tube. The imaging section includes an imaging resin element and an imaging metal element. The first outer layer and / or the second outer layer located at the distal end are imaging resin elements. In this case, the distal end of the dual-lumen microcatheter can be imaged, providing the surgeon with a larger area of ​​imaging to provide clear positioning information. The imaging metal element is located at the distal end and can provide a clear imaging effect. By having both the imaging metal element and the imaging resin element located at the distal end of the dual-lumen microcatheter, the high-intensity imaging characteristics of the imaging metal element, combined with the imaging resin element, can further improve the clarity of imaging, thereby improving the accuracy of positioning and better positioning of the dual-lumen microcatheter or guidewire. The imaging metal element is disposed inside, on the surface, or between the layers of the first outer layer and / or the second outer layer, which helps to avoid affecting the movement of the guidewire.

[0008] Furthermore, in the contrast-enhanced dual-lumen microcatheter of this invention, optionally, along the proximal to the distal end, the second tube body has a connecting section joined to the outer periphery of the first tube body and a tapered tip protruding from the first tube body; the second outer layer located at the tip is the contrast-enhancing resin element, and the contrast-enhancing metal element is embedded in the second outer layer and in contact with the contrast-enhancing resin element. In this case, the tapered tip can facilitate the advancement of the dual-lumen microcatheter; by making the contrast-enhancing resin element the outer layer of the tip, the entire tip can be contrasted, providing the surgeon with a larger area of ​​positioning information; the high-intensity contrast-enhancing properties of the contrast-enhancing metal element can further improve the clarity of the contrast; the adjacent contrast-enhancing resin elements and contrast-enhancing metal elements can combine to provide conspicuous and clear contrast information.

[0009] Furthermore, in the imaging-enhanced dual-lumen microcatheter of this invention, optionally, the first tube body further includes a first reinforcing layer and a second reinforcing layer. The first reinforcing layer is embedded in the first outer layer of the proximal segment and the transition segment; the second reinforcing layer is embedded in the first outer layer of the distal segment, and the second reinforcing layer extends partially or completely along the axial direction of the first tube body to the distal segment. In this case, the radial support of the proximal segment and the transition segment can be enhanced by the first reinforcing layer, and the radial support of the distal segment can be enhanced by the second reinforcing layer. This helps to improve the distal segment deformation caused by excessive force or insufficient radial support at the distal end of the dual-lumen microcatheter when the operator inserts the guidewire at the distal end of the dual-lumen microcatheter.

[0010] Furthermore, in the imaging-enhanced dual-lumen microcatheter of this invention, optionally, the diameter of the second reinforcing layer is smaller than the diameter of the first reinforcing layer. This further enhances the radial support of the distal segment.

[0011] Furthermore, in the imaging-enhanced dual-lumen microcatheter of this invention, the imaging metal element may optionally be a closed annular structure. In this case, imaging can be easily performed in various projection directions.

[0012] Furthermore, in the imaging-enhanced dual-lumen microcatheter of this invention, optionally, the imaging metal element is a semi-closed annular structure. In this case, when the distal end of the dual-lumen microcatheter rotates, the orientation of the distal end of the first tube (i.e., the opening of the first tube) can be determined by the change in the imaging shape of the semi-closed annular imaging metal element, thereby facilitating the operator to align the opening of the first tube with the target position and manipulate the guidewire to enter the target position.

[0013] Furthermore, in the contrast-enhanced dual-lumen microcatheter of this invention, optionally, the contrast-enhanced dual-lumen microcatheter is arranged with the first tube body above and the second tube body below, projected in the direction from the proximal end to the distal end, and the opening of the semi-closed annular structure is parallel or perpendicular to the arrangement direction of the first tube body and the second tube body. In this case, it is easier to indicate the orientation of the outlet of the first tube body by the orientation of the opening of the semi-closed annular structure, thereby facilitating precise operation by the surgeon.

[0014] Furthermore, in the imaging-enhanced dual-lumen microcatheter of this invention, optionally, along the proximal end to the distal end, the first outer layer is composed of multiple first segments with different hardnesses, and the second outer layer is composed of multiple second segments with different hardnesses. The hardness of the second segment located at the proximal end is higher than the hardness of the other second segments, but not lower than the hardness of the first segment it engages with. In this case, the higher hardness at the proximal end of the second tube reduces the risk of tearing at that point when the guidewire enters or exits the lumen of the second guidewire, thus improving tear resistance.

[0015] Furthermore, in the radiopaque-enhanced dual-lumen microcatheter of this invention, the radiopaque metal element may optionally be selected from gold, platinum, iridium, tungsten, and their alloys. This provides a radiopaque metal element with high density, high radiopaqueness, and good biocompatibility.

[0016] In addition, in the radiopaque-enhanced dual-lumen microcatheter of this invention, optionally, the radiopaque-enhanced dual-lumen microcatheter further includes a catheter seat and a stress buffer. The catheter seat is disposed on the outer periphery of the proximal segment, and the stress buffer is disposed on the outer periphery of the transition segment and connected to the catheter seat. In this case, assembling the catheter seat on the proximal segment facilitates guiding the guidewire, injecting reagents, or connecting it to other instruments within the lumen of the first guidewire. The stress buffer helps reduce bending of the dual-lumen microcatheter caused by stress concentration at the catheter seat connection.

[0017] According to this invention, a contrast-enhanced dual-lumen microcatheter can be provided, which is beneficial for achieving precise positioning of dual-lumen microcatheters or guidewires. Attached Figure Description

[0018] Embodiments of the present invention will now be explained in further detail by way of example with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram showing the overall structure of the dual-lumen microcatheter involved in the example of this utility model.

[0019] Figure 2 This is a schematic diagram of the overall structure of a dual-lumen microcatheter, illustrating another perspective of an example of this utility model.

[0020] Figure 3 This is an axial cross-sectional view showing a double-lumen microcatheter with a second reinforcing layer of the present invention, as illustrated in the first example.

[0021] Figure 4 This is an axial cross-sectional view showing a double-lumen microcatheter with a second reinforcing layer of the present invention, as an example of the second type.

[0022] Figure 5 This illustrates the present invention. Figure 3 or Figure 4 The diagram shows a cross-sectional structure of the double-lumen microcatheter along the AA direction.

[0023] Figure 6 This illustrates an example of the utility model involved. Figure 3 or Figure 4 A schematic diagram of the structural cross-section along the BB direction.

[0024] Figure 7 This illustrates an example of the utility model involved. Figure 3 or Figure 4 A schematic cross-sectional view of the structure along the CC direction.

[0025] Figure 8 This is an axial cross-sectional view of a dual-lumen microcatheter with another example of a radiopaque metal element according to the present invention.

[0026] Figure 9 This illustrates an example of the utility model involved. Figure 8 A schematic diagram of the cross-sectional structure of the tube along the AA direction.

[0027] Explanation of icon numbers: 1…Dual-lumen microcatheter, 10…First tube body, S1…Proximal segment, S2…Transition segment, S3…Distal segment, 11…First inner layer, 121…First reinforcing layer, 1211…Spring layer, 1212…Braided layer, 122…Second reinforcing layer, 13…First outer layer, a…First segment, b…First segment, c…First segment, d…First segment, e…First segment, 20…Second tube body, K1…Connecting segment, K2…Tip segment, 21…Second inner layer, 22…Second outer layer, f…Second segment, g…Second segment, h…Second segment, i…Second segment, j…Second segment (31…Reflecting resin component), 30…Reflecting section, 32…Reflecting metal component, 40…Catheter seat, 50…Stress buffer component. Detailed Implementation

[0028] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0029] It should be noted that the terms "first," "second," "third," and "fourth," etc., in the specification, claims, and accompanying drawings of this utility model are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices. In the following description, the same reference numerals are used for the same parts, and repeated descriptions are omitted. Additionally, the accompanying drawings are merely schematic diagrams, and the scale of the dimensions of the parts or the shape of the parts may differ from the actual figures.

[0030] This application relates to a radiopaque-enhanced dual-lumen microcatheter, which in this embodiment can be simply referred to as a "dual-lumen microcatheter". The dual-lumen microcatheter involved in this invention has excellent radiopaque performance.

[0031] The dual-lumen microcatheter involved in this utility model will be described and explained below with reference to the accompanying drawings.

[0032] To facilitate understanding, the application scenarios of the dual-lumen microcatheter 1 involved in this invention will be briefly described first. For example, in some examples, the dual-lumen microcatheter 1 involved in this invention can be used for interventional treatment of chronic total occlusion (CTO) of the coronary artery. Specifically, interventional treatment of CTO includes: firstly, pushing a guidewire into the coronary artery and reaching the location of the chronic total occlusion; then, allowing the dual-lumen microcatheter 1 to enter the location of the chronic total occlusion of the coronary artery along the guidewire; then, allowing the guidewire to enter the lesion area using the support force of the dual-lumen microcatheter 1; then, advancing the dual-lumen microcatheter 1 along the guidewire and entering the lesion area; finally, using the support force provided by the dual-lumen microcatheter 1 for the guidewire to cross the area of ​​the chronic total occlusion of the coronary artery. When a bifurcation lesion occurs, or when the lesion is located at a vascular bifurcation, the guidewire may enter a false lumen, forming a pathway into the false lumen. After the guidewire enters the false lumen through the lumen of the first guidewire, the false lumen pathway is sealed by the dual-lumen microcatheter 1, and another guidewire attempts to pass through the lumen of the second guidewire of the dual-lumen microcatheter 1 to enter the true lumen. In this case, since the false lumen pathway has been blocked by the dual-lumen microcatheter 1, the probability of the second guidewire entering the true lumen is greatly increased. It should be noted that this description indicates that the contrast-enhanced dual-lumen microcatheter 1 of this invention is particularly suitable for this application scenario, and does not mean that it is limited to use only in this scenario. The contrast-enhanced dual-lumen microcatheter 1 of this invention can also be used in other conventional scenarios where dual-lumen microcatheters 1 can be used.

[0033] In some examples, the dual-lumen microcatheter 1 can advance alongside the guidewire as it traverses the lesion area. This provides continuous support for the guidewire. In other examples, the dual-lumen microcatheter 1 can advance alternately with the guidewire. Specifically, the dual-lumen microcatheter 1 can alternately traverse the lesion area with the guidewire, thereby improving the reliability of the traverse and providing continuous support for the guidewire.

[0034] Figure 1 This is a schematic diagram showing the overall structure of the dual-lumen microcatheter 1 involved in the example of this utility model. Figure 2 This is a schematic diagram of the overall structure of the dual-lumen microcatheter 1, which is shown from another perspective in the example of this utility model.

[0035] like Figure 1 and Figure 2 As shown, in some examples, the dual-lumen microcatheter 1 may include a first tube body 10 and a second tube body 20. In some examples, the second tube body 20 may be partially joined to the outer periphery of the first tube body 10. In some examples, one end of the dual-lumen microcatheter 1 may be connected to a catheter seat 40. The catheter seat 40 can accommodate a guidewire. In some examples, the transition region of the dual-lumen microcatheter 1 connected to the catheter seat 40 may be fitted with a stress buffer 50. The stress buffer 50 can be used to prevent bending caused by stress concentration.

[0036] In some examples, the dual-lumen microcatheter 1 has a proximal end that is close to the surgeon during the procedure and a distal end that is farther from the surgeon during the procedure. It should be noted that the surgeon refers to the physician performing the surgery or medical procedure, who is the executor of the surgery or procedure.

[0037] In some examples, the chamber formed by the first tube 10 can be called an OTW (Over-The-Wire) chamber, also known as an overall exchange chamber. The chamber formed by the second tube 20 can be called an RX (Rapid Exchange) chamber, also known as a fast exchange chamber. The distal end of the first tube 10 has an opening, which is the OTW port. The proximal end of the second tube 20 has an opening, which is the RX port.

[0038] In some examples, the dual-lumen microcatheter 1 also includes a radiopaque section 30 (see Figure 1 The imaging unit 30 is capable of imaging under X-rays to position the double-lumen microcatheter 1. In some examples, the imaging unit 30 is located at the distal end of the double-lumen microcatheter 1. Thus, the distal end of the double-lumen microcatheter 1 can be imaged, that is, the outlet of the double-lumen microcatheter 1 can be imaged.

[0039] In some examples, the first tube 10 may have a proximal segment S1, a transition segment S2, and a distal segment S3 connected sequentially from proximal to distal end (see [reference]). Figure 2).

[0040] In some examples, the catheter hub 40 may be located on the periphery of the proximal segment S1. The stress buffer 50 may be located on the periphery of the transition segment S2 and connected to the catheter hub 40. In this case, the proximal segment S1, fitted with the catheter hub 40, facilitates the guidance of the guidewire, injection of reagents, or connection to other instruments within the lumen of the first guidewire, while the stress buffer 50 helps prevent bending of the double-lumen microcatheter 1 due to stress concentration at the connection point of the catheter hub 40.

[0041] Figure 3 This is an axial cross-sectional view showing a double-lumen microcatheter with a second reinforcing layer as described in the first example of this invention. Figure 4 This is an axial cross-sectional view showing a double-lumen microcatheter with a second reinforcing layer according to a second example of the present invention. Figure 5 This illustrates an example of the utility model involved. Figure 3 or Figure 4 A schematic diagram of the cross-sectional structure of the tube along the AA direction. Figure 6 This illustrates an example of the utility model involved. Figure 3 or Figure 4 A schematic cross-sectional view of the structure along the BB direction. Figure 7 This illustrates an example of the utility model involved. Figure 3 or Figure 4 A schematic cross-sectional view of the structure along the CC direction.

[0042] like Figure 3 or Figure 4 As shown, in some examples, the first tube 10 may include a first inner layer 11 and a first outer layer 13 located outside the first inner layer 11. The first inner layer 11 may form a first guidewire lumen for slidably receiving a guidewire. That is, the first tube 10 has a first guidewire lumen for slidably receiving a guidewire.

[0043] In some examples, the first inner layer 11 may be selected from a polymer material. In some examples, the first inner layer 11 may be made of a relatively smooth polymer material. This facilitates relative sliding between the guidewire and the first guidewire lumen. In some examples, the first inner layer 11 may be selected from polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkylene (PFA), polyethylene terephthalate (PET), and polyetheretherketone (PEEK).

[0044] In some examples, the first outer layer 13 may be selected from a polymer material. In some examples, the first outer layer 13 may be a thermoplastic resin material. This facilitates the fixing of the first tube body 10 to the first inner layer 11 by means of heat melting, thermoplasticizing, or heat shrinking, thus forming an integral part of the first tube body 10. In some examples, the first outer layer 13 may be selected from polyamide (PA), polyether block polyamide (PEBAX), polyurethane (TPU), polyether ether ketone (PEEK), polyimide (PI), polyphenylene sulfone (PPSU / PES), synthetic rubber, and other synthetic rubbers.

[0045] In some examples, the first outer layer 13 may consist of multiple first segments. The hardness of the different first segments may vary. In some examples, the hardness of the first outer layer 13 may be 30~90 HA, where HA represents the Shore hardness value. For example, as... Figure 3 As shown, along the direction from proximal to distal, the first outer layer 13 may sequentially include first segment a, first segment b, first segment c, first segment d, and first segment e. First segment a, first segment b, first segment c, first segment d, and first segment e are connected sequentially.

[0046] In some examples, the first segments a, b, c, d, and e have different hardness values. This allows for the selection of appropriate hardness based on the different positions of the first segments, further improving the bending resistance of the dual-lumen microcatheter 1 while ensuring flexibility. Specifically, the first segments with different hardnesses can be spliced ​​together and then fitted onto the outer periphery of the first inner layer 11, and fixed by heat fusion, thermoplasticizing, or heat shrinking to form an integrated first outer layer 13. In some examples, the hardness of the first segments a, b, c, d, and e decreases sequentially. This enhances the bending resistance of the dual-lumen microcatheter 1.

[0047] In some examples, the first segment a can be set in the proximal segment S1 and the transition segment S2. The first segment b can be set in the transition segment S2 and the distal segment S3. The first segments c, d, and e can be set in the distal segment S3.

[0048] In some examples, the first tube body 10 may include a reinforcing layer. The reinforcing layer may be disposed within the first outer layer 13 to enhance the radial support of the dual-lumen microcatheter 1.

[0049] In some examples, the reinforcing layer may include a first reinforcing layer 121 and a second reinforcing layer 122. For example... Figure 3 or Figure 4In some examples, the first tube body 10 may include a first reinforcing layer 121. In some examples, the first reinforcing layer 121 may be embedded in a first outer layer 13. The first reinforcing layer 121 may be located in the proximal segment S1 and / or the transition segment S2. In some examples, the first reinforcing layer 121 is embedded in the first outer layer 13 of the proximal segment S1 and the transition segment S2. Thus, the radial support of the dual-lumen microcatheter 1 at the proximal segment S1 and the transition segment S2 can be improved by the first reinforcing layer 121.

[0050] In some examples, the first reinforcing layer 121 may extend axially throughout the proximal section S1 and the transition section S2 of the first tube body 10. In other words, in some examples, the first reinforcing layer 121 may axially penetrate the entire proximal section S1 and the transition section S2 of the first tube body 10. Thus, the entire proximal section S1 and the transition section S2 are provided with the first reinforcing layer 121, which can improve the radial support of the entire proximal section S1 and the transition section S2.

[0051] In other examples, the first reinforcing layer 121 may extend in the axial portion of the first tube body 10 into the proximal section S1 and the transition section S2. In other words, in other examples, the first reinforcing layer 121 may penetrate the proximal section S1 and the transition section S2 in the axial portion of the first tube body 10. It should be noted that the first outer layer 13 at the proximal section S1 and the transition section S2 typically has higher rigidity and better support than the distal section S3; in this case, by providing the first reinforcing layer 121 in part of the proximal section S1 or part of the transition section S2, a good and sufficient improvement in the radial support of the proximal section S1 or the transition section S2 can be achieved.

[0052] In some examples, the first reinforcing layer 121 may include at least one of a spring layer 1211 and a braided layer 1212. Thus, the strength of the dual-lumen microcatheter 1 can be further enhanced by the spring layer 1211 and the braided layer 1212. In some examples, the spring layer 1211 may be made of metal. Specifically, the spring layer 1211 may be made of 304 stainless steel wire. In some examples, the braided layer 1212 may be made of metal or fiber. Specifically, the braided layer 1212 may be made of 304 stainless steel.

[0053] In some examples, the spring layer 1211 may be wound around the first inner layer 11 and arranged along the length of the first inner layer 11 (see [reference]). Figure 3 In some examples, the braided layer 1212 may be disposed outside the spring layer 1211 (see [reference]). Figure 3In this case, even if a continuous torque is input from the outside, the portion of the spring layer 1211 wrapped with the braided layer 1212 will not come apart because of the protection of the outer braided layer 1212, thereby improving the reliability of the dual-lumen microcatheter 1.

[0054] In some examples, the spring layer 1211 may be arranged along the outer periphery of the first inner layer 11 and in close contact with the first inner layer 11. For example, the spring layer 1211 may be formed by winding wire in a clockwise direction. Alternatively, the spring layer 1211 may be formed by winding wire in a counterclockwise direction.

[0055] In some examples, the braided layer 1212 may be arranged along the outer periphery of the first inner layer 11 and closely adhering to the spring layer 1211 (e.g. Figure 7 For example, braided layer 1212 can be formed by winding braided yarn in a clockwise direction. Alternatively, braided layer 1212 can be formed by winding braided yarn in a counterclockwise direction. In other examples, braided layer 1212 can be formed by interlacing braided yarn in a mesh pattern.

[0056] In some examples, the first tube 10 may include a second reinforcing layer 122 (e.g., Figure 3 , Figure 4 , Figure 6 In some examples, the first tube body 10 may be located in the distal segment S3. In some examples, the second reinforcing layer 122 may be embedded in the first outer layer 13 of the distal segment S3. Thus, the radial support of the dual-lumen microcatheter 1 at the distal segment S3 can be improved by the second reinforcing layer 122. In some examples, the second reinforcing layer 122 may include at least one of a spring layer and a braided layer.

[0057] In some examples, the second reinforcing layer 122 may extend in the axial portion of the first tube 10 to the distal segment S3 (see [reference]). Figure 4 In other words, in some examples, the second reinforcing layer 122 can partially penetrate (i.e., partially penetrate) the distal segment S3 in the axial direction of the first tube body 10. This enhances the radial support of the distal segment S3 through the second reinforcing layer 122, thereby helping to mitigate deformation of the distal segment S3 caused by excessive force or insufficient radial support at the distal end of the dual-lumen microcatheter 1 when the operator inserts the guidewire.

[0058] In some examples, the second reinforcing layer 122 may extend axially to the distal segment S3 of the first tube 10 (see [reference]). Figure 3 In other words, in some examples, the second reinforcing layer 122 can completely penetrate (i.e., fully penetrate) the distal segment S3 in the axial direction of the first tube 10. This allows the second reinforcing layer 122 to provide stronger radial support to the distal segment S3.

[0059] In some examples, the diameter of the second reinforcing layer 122 can be smaller than the diameter of the first reinforcing layer 121 (e.g.) Figure 3 or Figure 4 This further enhances the radial support of the second reinforcing layer 122 to the distal segment S3.

[0060] In some examples, the second tube 20 may have a connecting segment K1 and a tip segment K2 connected sequentially from proximal to distal. The connecting segment K1 may engage with the outer periphery of the first tube 10. The tip segment K2 may protrude from the first tube 10. The tip segment K2 may taper from proximal to distal. This facilitates the advancement of the dual-lumen microcatheter 1.

[0061] In some examples, the second tube 20 may include a second inner layer 21 and a second outer layer 22 located outside the second inner layer 21. The second inner layer 21 may form a second guidewire lumen for slidably receiving a guidewire. That is, the second tube 20 has a second guidewire lumen for slidably receiving a guidewire.

[0062] In some examples, the second inner layer 21 may be selected from a polymer material. In some examples, the second inner layer 21 may be made of a relatively smooth polymer material. This facilitates the relative sliding of the guidewire and the lumen of the second guidewire. In some examples, the second inner layer 21 may be selected from polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkylene (PFA), polyethylene terephthalate (PET), and polyetheretherketone (PEEK).

[0063] In some examples, the second outer layer 22 may be selected from a polymer material. In some examples, the second outer layer 22 may be a thermoplastic resin material. This facilitates the fixation of the second outer layer 21 to the second inner layer 21 by means of heat melting, thermoplasticizing, or heat shrinking, thus forming an integral second tube 20 with the second inner layer 21. In some examples, the second outer layer 22 may be selected from polyamide (PA), polyether block polyamide (PEBAX), polyurethane (TPU), polyether ether ketone (PEEK), polyimide (PI), polyphenylene sulfone (PPSU / PES), synthetic rubber, and other synthetic rubbers.

[0064] In some examples, the second outer layer 22 may consist of multiple second segments. The hardness of different second segments may vary. In some examples, the hardness of the second outer layer 22 may be 30–90 HB, where HB represents the Brinell hardness value. For example, as... Figure 3As shown, along the direction from proximal to distal, the second outer layer 22 may sequentially include second segment f, second segment g, second segment h, second segment i, and second segment j.

[0065] In some examples, the second segments f, g, h, i, and j have different hardness values. This allows for the selection of appropriate hardness based on the different positions of the second segments, further improving the bending resistance of the dual-lumen microcatheter 1 while ensuring flexibility. Specifically, the second segments with different hardnesses can be spliced ​​together and then fitted onto the second inner layer 21, and fixed to the outer periphery of the second inner layer 21 by heat fusion, thermoplasticizing, or heat shrinking to form an integrated second outer layer 22. In some examples, the hardness of the second segments f, g, h, i, and j decreases sequentially. This enhances the bending resistance of the dual-lumen microcatheter 1.

[0066] In some examples, second segments f, g, h, and i can be located in the connecting segment K1. Second segment j can be located in the tip segment K2.

[0067] refer to Figure 3 In some examples, the hardness of the second segment at the proximal end (i.e., second segment f) can be higher than that of the other second segments (the other second segments refer to second segments g, h, i, and j) and not lower than that of the first segment it engages with (the first segments engaged with second segment f refer to first segments b and c). In this case, the higher hardness at the proximal end of the second tube reduces the risk of tearing at that point when the guidewire enters or exits the second guidewire lumen, thus improving the tear resistance of the second guidewire lumen opening.

[0068] In some examples, the hardness of the first segment a, the second segment f, the first segment b, and the first segment c can decrease sequentially. In some examples, the hardness of the second segment g, the first segment d, the second segment h, the first segment e, the second segment i, and the second segment j can decrease sequentially. Therefore, by setting the hardness to decrease stepwise, the hardness of the dual-lumen microcatheter 1 can be gradually changed, resulting in good flexibility; by alternating the decrease in hardness of the first and second segments, the difference in flexibility between the first outer layer 13 and the second outer layer 22 can be increased, thereby improving the bending resistance of the dual-lumen microcatheter 1.

[0069] In some examples, the second tube 20 may also include a reinforcing layer (not shown). The reinforcing layer may be disposed within the second outer layer 22 to enhance the radial support of the dual-lumen microcatheter 1. The reinforcing layer may include at least one of a spring layer and a braided layer. A description of the reinforcing layer of the second tube 20 can be found in the description of the reinforcing layer of the first tube 10; the reinforcing layer of the second tube 20 may be the same as the reinforcing layer of the first tube 10.

[0070] like Figure 1 or Figure 4 As shown, in some examples, the dual-lumen microcatheter 1 further includes a imaging section 30. The imaging section 30 may be disposed at the distal end of the dual-lumen microcatheter 1. Thus, the distal end of the dual-lumen microcatheter 1 can be imaging, that is, the outlet of the dual-lumen microcatheter 1 can be imaging.

[0071] In some examples, the developing unit 30 may include a developing resin member 31. In some examples, the developing unit 30 may include a developing metal member 32. In some examples, the developing unit 30 may include both a developing resin member 31 and a developing metal member 32.

[0072] In some examples, the developing resin component 31 may be composed of resin and developing material. The developing material may be at least one of the following: gold, platinum, iridium, platinum-iridium alloy, barium, barium sulfate, bismuth, bismuth-based compounds, zirconium oxide, tantalum, cobalt-chromium alloy, tungsten, tungsten-based compounds, stainless steel, titanium, or other non-transmitting linear metals or metallic compounds. Among these, bismuth-based compounds may be, for example, bismuth oxide, bismuth trioxide, bismuth oxycarbonate, bismuth subcarbonate, or bismuth tungstate. Tungsten-based compounds may be, for example, tungsten oxide, tungsten dioxide, or tungsten trioxide. In some examples, the developing material may be in powder form. In some examples, in the developing resin component 31, the developing material is dispersed in the resin in powder form. In some examples, the developing material content (mass percentage) in the developing resin component 31 may be 30% to 90%. Thus, the developing material can provide good developing effect to the resin.

[0073] In some examples, the developing metal element 32 can be made of pure metal. In some examples, the developing metal element 32 can be selected from gold, platinum, iridium, tungsten, and their alloys. Thus, a developing metal element 32 with high density, high developability, and good biocompatibility can be provided.

[0074] In some examples, the first outer layer 13 and / or the second outer layer 22 located distally are radiopaque resin elements 31. For example, the first segment e can be a radiopaque resin element 31, or the second segment j can be a radiopaque resin element 31, or both the first segment e and the second segment j can be radiopaque resin elements 31. This provides a larger area of ​​radiopaque coverage, allowing the operator to clearly identify the distal location of the double-lumen microcatheter 1.

[0075] In some examples, the radiopaque metal element 32 can be positioned at the distal end of the dual-lumen microcatheter 1. This allows the high radiopaqueness of the radiopaque metal element 32 to indicate the distal position of the dual-lumen microcatheter 1.

[0076] In some examples, the developing metal part 32 can be in contact with the developing resin part 31. Therefore, the high developing properties of the developing metal part 32 can further enhance the clarity of the developed image, and the developing metal part 32 can be combined with the developing resin part 31 to improve the developing effect.

[0077] In some examples, the imaging metal element 32 may be disposed inside, on the surface, or between the layers of the first outer layer 13 and / or the second outer layer 22. For example, the imaging metal element 32 may be disposed inside the first outer layer 13, or on the surface of the second outer layer 22, or between the first outer layer 13 and the second outer layer 22. Preferably, the imaging metal element 32 may be disposed inside or between the first outer layer 13 and / or the second outer layer 22, thereby helping to reduce the impact of the imaging metal element 32 on the smoothness of the push of the dual-lumen microcatheter 1.

[0078] In some examples, the second outer layer 22 located at the tip segment K2 can be a developing resin element 31, and a developing metal element 32 can be embedded in the second outer layer 22. For example, the second segment j can be a developing resin element 31, and the developing metal element 32 can be embedded in the second outer layer 22, with the developing metal element 32 and the developing resin element 31 in contact. In some examples, the developing metal element 32 is located below the outlet of the first guidewire lumen. In this case, the location of the outlet of the first guidewire lumen can be indicated by the development of the developing metal element 32 and the developing resin element 31.

[0079] like Figure 5 As shown, in some examples, the developing metal element 32 can be a closed annular structure. In this case, it is convenient to develop in various projection directions.

[0080] Figure 8 This is an axial cross-sectional view showing a dual-lumen microcatheter with another example of a radiopaque metal element according to the present invention. Figure 9 This illustrates an example of the utility model involved. Figure 8 A schematic diagram of the cross-sectional structure of the tube along the AA direction.

[0081] like Figure 8 and Figure 9As shown, in some examples, the imaging metal element 32 can be a semi-closed annular structure. In other words, the imaging metal element 32 can be a semi-annular structure. In this case, when the distal end of the dual-lumen microcatheter 1 rotates, the orientation of the outlet of the first tube body 10 (i.e., the outlet of the first guidewire lumen) can be determined by the change in the imaging shape of the semi-closed annular imaging metal element 32.

[0082] In some examples, the double-lumen microcatheter 1 is arranged with the first tube 10 above and the second tube 20 below, projected in a proximal-to-distal direction. The opening of the semi-closed annular structure is parallel or perpendicular to the arrangement direction of the first and second tubes. That is, with the first tube 10 above and the second tube 20 below, and projected in a proximal-to-distal direction, the opening of the semi-closed annular structure can face directly upward, downward, left, or right. In this case, it is easier to indicate the orientation of the outlet of the first tube 10. It should be noted that, for example, assuming the opening of the semi-closed annular structure faces directly upwards, when X-rays are irradiated from the outside, as the surgeon rotates the dual-lumen microcatheter 1 to gradually shorten the length of the line ("I" shape) formed by the projection of the imaging metal element 32 to its shortest state, this indicates that the outlet of the first guidewire lumen is facing upwards or downwards; when the length of the line ("I" shape) formed by the projection of the imaging metal element 32 gradually lengthens to its longest state, this indicates that the outlet of the first guidewire lumen is facing left or right (that is, the outlet of the first guidewire lumen is perpendicular to the screen outwards or perpendicular to the screen inwards). Therefore, the surgeon can accurately determine the orientation of the outlet of the first guidewire lumen by observing the changes in the projection of the imaging metal element 32, facilitating precise operation.

[0083] In some examples, the developing metal part 32 can be fixed to the outer periphery of the second inner layer 21 near the tip segment K2. The fixing method can be one of heat fusion, heat molding, heat shrinking, soldering, or snap-fit. Thus, the developing metal part 32 can be fixed near the tip segment K2 by one of these methods.

[0084] In some examples, the developing metal part 32 can be firmly fixed to the outer wall of the second inner layer by micro-spot welding or mechanical embedding. In some examples, the second outer layer 22 covering the outside of the developing metal part 32 can be wrapped and encapsulated by a thermoplastic reconstruction process to form a smooth, integrated distal structure. This helps to ensure that there is no relative rotation between the developing metal part 32 and the second tube body, improving the accuracy of positioning.

[0085] In summary, according to this utility model, a dual-lumen microcatheter 1 with better imaging effect and improved positioning accuracy can be provided.

[0086] Although the present invention has been specifically described above in conjunction with the accompanying drawings and embodiments, it is to be understood that the above description does not limit the present invention in any way. Those skilled in the art can make modifications and variations to the present invention as needed without departing from the essential spirit and scope of the present invention, and all such modifications and variations fall within the scope of the present invention.

Claims

1. A contrast-enhanced dual-lumen microcatheter, characterized in that, The imaging-enhanced dual-lumen microcatheter includes a first tube body, a second tube body, and an imaging section for positioning; The contrast-enhanced dual-lumen microcatheter has a proximal end that is close to the operator during operation and a distal end that is far from the operator during operation; the first tube body has a first guidewire lumen that slidably receives a guidewire, the first tube body including a first inner layer forming the first guidewire lumen and a first outer layer located outside the first inner layer; the second tube body has a second guidewire lumen that slidably receives a guidewire, the second tube body including a second inner layer forming the second guidewire lumen and a second outer layer located outside the second inner layer; the contrast-enhancing part includes a contrast-enhancing resin element and a contrast-enhancing metal element; wherein, the first outer layer located at the distal end and / or the second outer layer located at the distal end are the contrast-enhancing resin elements; the contrast-enhancing metal element is disposed at the distal end of the contrast-enhanced dual-lumen microcatheter and is configured inside, on the surface or between the layers of the first outer layer and / or the second outer layer.

2. The imaging-enhanced dual-lumen microcatheter according to claim 1, characterized in that, Along the proximal end to the distal end, the second tube has a connecting section that engages with the outer periphery of the first tube and a tapering tip section that protrudes from the first tube. The second outer layer located at the tip section is the developing resin element, and the developing metal element is embedded in the second outer layer and in contact with the developing resin element.

3. The imaging-enhanced dual-lumen microcatheter according to claim 1, characterized in that, Along the proximal end to the distal end, the first tube has a proximal segment, a transition segment and a distal segment connected in sequence, wherein the first tube further includes a first reinforcing layer and a second reinforcing layer, the first reinforcing layer being embedded in the first outer layer of the proximal segment and the transition segment; the second reinforcing layer being embedded in the first outer layer of the distal segment, and the second reinforcing layer extending partially or completely along the axial direction of the first tube to the distal segment.

4. The imaging-enhanced dual-lumen microcatheter according to claim 3, characterized in that, The diameter of the second reinforcing layer is smaller than the diameter of the first reinforcing layer.

5. The imaging-enhanced dual-lumen microcatheter according to any one of claims 1 to 4, characterized in that, The developing metal part has a closed ring structure.

6. The imaging-enhanced dual-lumen microcatheter according to any one of claims 1 to 4, characterized in that, The developing metal part has a semi-closed ring structure.

7. The imaging-enhanced dual-lumen microcatheter according to claim 6, characterized in that, The imaging-enhanced dual-lumen microcatheter is arranged with the first tube above and the second tube below, and projected in the direction from the proximal end to the distal end. The opening of the semi-closed annular structure is parallel or perpendicular to the arrangement direction of the first tube and the second tube.

8. The imaging-enhanced dual-lumen microcatheter according to claim 1, characterized in that, Along the proximal end to the distal end, the first outer layer is composed of a plurality of first segments with different hardnesses, and the second outer layer is composed of a plurality of second segments with different hardnesses, wherein the hardness of the second segment located at the proximal end is higher than the hardness of the other second segments and not lower than the hardness of the first segment it is engaged with.

9. The imaging-enhanced dual-lumen microcatheter according to claim 1, characterized in that, The developing metal is selected from gold, platinum, iridium, tungsten, and their alloys.

10. The imaging-enhanced dual-lumen microcatheter according to claim 3, characterized in that, The imaging-enhanced dual-lumen microcatheter also includes a catheter seat and a stress buffer. The catheter seat is disposed on the outer periphery of the proximal segment, and the stress buffer is disposed on the outer periphery of the transition segment and connected to the catheter seat.

Images