Catheter assembly for catheter pump, catheter pump and method for making the catheter assembly

Abstract

The present invention discloses a catheter assembly for a catheter pump, a catheter pump and a method for manufacturing the catheter assembly. The catheter assembly for the catheter pump comprises: a catheter, a first wire body and a second wire body inserted in the catheter. At least a portion of the first wire body located in the catheter is spirally arranged to form a receiving channel, and the second wire body is inserted in the receiving channel.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a catheter assembly for a catheter pump, a catheter pump using the catheter assembly, and a method for manufacturing the catheter assembly. Background Art

[0002] The catheter pump includes a catheter and a pump assembly connected to the catheter. The catheter provides space for storing wires. For example, the wires connected to the motor, the optical fibers of the sensor, the flushing liquid tube, etc., all need to pass through the catheter to connect to the pump assembly. Since the catheter pump has a low profile retention requirement, the catheter is thinner. As a result, the catheter has less space for storing these wires.

[0003] In the prior art, the above-mentioned multiple wires are all inserted into the narrow and elongated catheter along the axial direction, which is extremely difficult to insert. In addition, the diameters of these wires are different, and they rub against each other and get entangled during insertion, further increasing the difficulty of insertion. Summary of the invention

[0004] In view of this, the present invention provides a catheter assembly for a catheter pump, a catheter pump and a method for manufacturing the catheter assembly.

[0005] The catheter assembly for the catheter pump comprises a catheter, a first wire body and a second wire body arranged in the catheter. The first wire body is arranged at least partially in a spiral section in the catheter to form an axially extending receiving channel, and the second wire body is arranged in the receiving channel.

[0006] The catheter pump comprises the above-mentioned catheter assembly and a pump assembly connected to the distal end of the catheter assembly, and the first wire body is the wire of the motor.

[0007] The method for making a catheter assembly includes: spirally arranging a first wire body outside a liner core; arranging a second wire body on the liner core; introducing the liner core into the catheter; and pulling the liner core out of the catheter to position the first wire body and the second wire body in the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 This is a schematic diagram of a catheter pump according to an embodiment of the present invention when used as a left heart assist;

[0009] Figure 2 It is a schematic diagram of the enlarged structure of the catheter pump and the catheter assembly according to an embodiment of the present invention;

[0010] Figure 3 is a cross-sectional view of a catheter assembly according to an embodiment of the present invention;

[0011] Figure 4 is a schematic diagram of a structure in which a first wire body is formed on a liner core;

[0012] Figure 5 It is a cross-sectional view when the lining core is a solid structure;

[0013] Figure 6 It is a cross-sectional view when the lining core is a hollow structure;

[0014] Fig. 7A It is a schematic diagram that the first wire body is formed on the liner core, and the second wire body and the traction wire are respectively connected to two ends of the liner core;

[0015] Figure 7B Schematic diagram of the movement of the liner core and the second wire body toward the catheter in order to pull the traction wire;

[0016] Figure 7C for Figure 7B A schematic diagram of pulling the liner core to draw the second wire body to the catheter;

[0017] Fig.7D for Figure 7C Schematic diagram of the catheter after glue injection at both ends;

[0018] Fig. 8A A schematic diagram of forming a first wire body on a liner core and connecting a traction wire to the liner core;

[0019] Figure 8B for Fig. 8A A schematic diagram of pulling the traction wire to pull the liner core to the catheter;

[0020] Figure 8C A schematic diagram of the second wire body penetrating into the hollow liner core;

[0021] Fig.8D It is a schematic diagram of the lining core, the first line body and the second line body in place;

[0022] Fig. 8E It is a schematic diagram after the liner core is removed;

[0023] Fig.8F This is a schematic diagram of the two ends of the catheter after glue injection;

[0024] Fig. 9A A schematic diagram of a first wire body being formed on a liner core, a second wire body being introduced into the liner core, and a traction wire being connected to the liner core;

[0025] Fig. 9B for Fig. 9A A schematic diagram of pulling the traction wire to introduce the liner core, the first wire body and the second wire body into the catheter;

[0026] Fig. 9C for Fig. 9B Schematic diagram after the liner core is removed;

[0027] Fig.9D for Fig. 9C Schematic diagram of the middle duct after glue injection at both ends. DETAILED DESCRIPTION

[0028] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments.

[0029] The terms "first", "second", etc. used in the present invention are used to distinguish similar objects, rather than to describe a specific order or sequence. The directional terms "proximal", "distal", "front", and "rear" are relative to the doctor who operates the catheter pump. "Proximal" and "rear" refer to the parts relatively close to the doctor, and "distal" and "front" refer to the parts relatively far away from the doctor. For example, the handle is located at the proximal or rear end, and the pump assembly is located at the distal or front end. It should be understood that these directional terms are defined for the convenience of description. Since the catheter pump can be used in many directions and positions, these directional terms are not restrictive and absolute.

[0030] like Figure 1 and Figure 2 As shown, the catheter pump includes a catheter assembly 900 and a pump assembly 1000. The pump assembly 1000 includes: a motor 200 connected to the distal end of the catheter assembly 900, an impeller (not shown) driven by the motor 200 to rotate for pumping blood, a bleeding window 310 connected to the distal end of the motor 200, a fluid cannula 300 connected to the distal end of the bleeding window 310, a blood inlet window 320 connected to the distal end of the fluid cannula 300, a protective structure 330 connected to the distal end of the blood inlet window 320, a distal sensor 340 provided on the blood inlet window 320, a proximal sensor 350 provided on the bleeding window 310, a blood inlet port 321 formed on the blood inlet window 320, and a bleeding port 311 formed on the bleeding window 310. The pump assembly 1000 can be inserted into the patient's body by percutaneous puncture, and pushed forward by the catheter assembly 900 in the patient's aorta until the blood inlet window 320 passes through the aortic valve AV and enters the left ventricle LV, and the fluid cannula 300 crosses the aortic valve AV, and the bleeding port 311 is located in the aorta AO. When the pump assembly 1000 is in operation, the blood in the left ventricle LV can be pumped to the aorta AO to assist the heart's pumping function and reduce the heart's burden.

[0031] The above example is used as a left ventricular assist, which is only a feasible application scenario of the catheter pump. In other scenarios, the catheter pump can also be used as a right ventricular assist pump, and the catheter assembly 900 is inserted into the right ventricle, so that the blood inlet 321 is located in the right ventricle and the bleeding port 311 is located in the pulmonary artery. The following is explained with the catheter pump used as a left ventricular assist as the main scenario, but based on the above description, it can be seen that the protection scope of the embodiment of the present invention is not limited by this.

[0032] like Figure 1 and Figure 2As shown, the catheter assembly 900 includes a catheter 100, a first wire body 210 and a second wire body 220 that are inserted into the catheter 100. The proximal end of the catheter 100 is connected to the handle 910, and the distal end is connected to the motor 200. The handle 910 is connected to the control device 930 through the cable 920, and at least one of the first wire body 210 and the second wire body 220 is connected to the cable 920 in the handle 910 to realize the electrical or signal connection between the pump assembly 1000 and the control device 930. For example, the first wire body 210 is a wire connected to the motor 200, and the control device 930 provides the motor 200 with an electric energy signal to drive the motor 200 to operate through the first wire body 210. The second wire body 220 is a signal line connected to the sensors 340 and 350, and is used to transmit the signals (for example, pressure signals) detected by the sensors 340 and 350 to the control device 930.

[0033] The sensors 340 and 350 may adopt any suitable existing structure, including but not limited to piezoelectric pressure sensors, piezoresistive pressure sensors, optical fiber pressure sensors, etc., which are not limited in this embodiment. Corresponding to the above-mentioned various types of pressure sensors, the second line body 220 as a signal line is a cable, a cable, and an optical fiber.

[0034] The number of the first wire bodies 210 is equal to the number of phases of the motor 200. For example, a three-phase motor is commonly used in the art, and the first wire bodies 210 are three. Correspondingly, when the motor 200 is a single-phase, two-phase, four-phase or even more-phase motor, the first wire bodies 210 are one, two, four or more. Regarding the connection between motors with different numbers of phases and the corresponding number of wires, please refer to the description of CN118043103A, which will not be repeated here.

[0035] The second line body 220 is not limited to the above-mentioned sensor signal line, and its number varies according to the change of the applicable scenario. For example, the second line body 220 can be only one, which is an optical fiber or a flushing tube, corresponding to the scenario where the catheter pump is configured with a single sensor (for example, only the proximal sensor 350) or flushing seal. The second line body 220 can also be two, which are two optical fibers, or one optical fiber + a flushing tube, corresponding to the scenario where the catheter pump is configured with dual sensors, or a single sensor (for example, only the proximal sensor 350) + flushing seal. The second line body 220 can also be three, which are two optical fibers + a flushing tube, corresponding to the scenario where the catheter pump is configured with dual sensors + flushing seal. Among them, the specific description of the flushing seal scenario can be referred to US9550017B2, which will not be repeated here.

[0036] like Figure 2 and Figure 3As shown, at least a portion of the first wire body 210 located in the catheter 100 is arranged in a spiral shape to form a receiving channel 110 extending along the axial direction of the catheter 100, and the second wire body 220 is inserted into the receiving channel 110. The spiral section 211 of the first wire body 210 abuts against the inner wall of the catheter 100, and the radius of the receiving channel 110 is greater than the radial distance between the spiral section 211 of the first wire body 210 and the inner wall of the catheter 100, so as to ensure that the receiving channel 110 has a sufficiently large receiving space for the second wire body 220 to pass through.

[0037] This embodiment adopts a spirally configured first wire body 210, and allows the second wire body 220 to pass through the receiving channel 110 of the first wire body 210, which has at least the following beneficial effects:

[0038] 1. The spirally configured first wire body 210 not only provides space for the second wire body 220 to be inserted, thereby reducing the difficulty of inserting the second wire body 220, but also avoids distortion in the axial space due to entanglement between the second wire body 220 and the first wire body 210, thereby increasing the axial and radial degrees of freedom of the second wire body 220 and reducing the stress on the second wire body 220 due to the bending of the catheter 100.

[0039] 2. During the intervention of the catheter pump, the catheter 100 needs to bend and deform in accordance with the curvature of the patient's blood vessels. Compared with the traditional axially threaded wire body, the spirally configured first wire body 210 can play a toughness gain role for the catheter 100, improve the bending resistance or bending resilience of the catheter 100, and avoid kinking (Kink) caused by the inability of the catheter 100 to recover due to excessive bending. In addition, the good bending resistance or bending resilience of the catheter 100 provides better pushing performance, ensuring the smooth intervention of the catheter assembly 900.

[0040] 3. Taking the second wire body 220 as an optical fiber as an example, the traditional method of threading the optical fiber requires inserting a fiber optic sleeve for protecting the optical fiber into the catheter 100 in advance. Since the fiber optic sleeve is a hollow and thin-walled hollow tube, the material strength is much weaker than the motor wire. In the narrow catheter cavity, the motor wire will squeeze the fiber optic sleeve, causing the fiber optic sleeve to deform radially or even kink. This will cause the passage of the fiber optic sleeve to be blocked and the optical fiber cannot be inserted. The spiral setting of the first wire body 210 reduces the occupancy of the catheter cavity. When the diameter of the catheter 100 remains unchanged, the space reserved for the optical fiber is increased, and the axial and radial degrees of freedom of the optical fiber are increased, so that the optical fiber can be threaded and positioned even without a fiber optic sleeve, reducing the difficulty of threading the optical fiber.

[0041] 4. Make the wiring in the catheter 100 more regular and avoid the adverse consequences caused by the entanglement of the wires. As described above, the spirally configured first wire 210 provides more space for the second wire 220 to pass through, so that compared with the traditional wiring method of the first wire 210 (such as the motor wire) and the second wire 220 (such as the optical fiber) both extending axially, the friction generated by the contact between the spiral first wire 210 and the axially extending second wire 220 is greatly reduced, and the phenomenon that the axial movement freedom of the second wire 220 and the first wire 210 is restrained or interfered with each other due to the friction is basically avoided, preventing the first wire 210 and the second wire 220 from entangled and tangled together, and thus avoiding the entanglement that causes the first wire 210 and / or the second wire 220 to be under stress all the time, which is beneficial to prevent the weaker optical fiber from being broken, kinked, radially collapsed, etc.

[0042] 5. When assembling the catheter assembly 900 and the motor 200, it is necessary to first thread the first wire 210 and the second wire 220 into the catheter 100, and then connect the catheter 100 to the motor 200. Since the first wire 210 and the second wire 220 are both led out from the proximal end of the motor 200, sometimes in order to align the catheter 100 and the motor 200 in a specific orientation to avoid bending of the second wire 220, it is necessary to rotate the catheter 100 and / or the motor 200. The traditional axial threading method will cause the wire to twist in the catheter 100 due to this rotation, resulting in greater stress on the wire. When the catheter assembly 900 of this embodiment is connected to the motor 200, even if there is rotation, the spiral first wire 210 will adaptively untwist or add rotation to absorb or release the stress caused by the rotation. Although the second wire body 220 is still inserted axially, it has more space and freedom, and is not tightly attached to the first wire body 210 and the inner wall of the catheter 100 as in the prior art. Therefore, the above-mentioned rotation will not cause the second wire body 220 to be twisted together with the first wire body 210 and the catheter 100, thereby effectively avoiding the generation of torsional stress in the second wire body 220, which is beneficial to avoiding the second wire body 220 from breaking, kinking, radial collapse, etc. as mentioned above.

[0043] 6. Under the condition of the same axial length, the first wire 210 arranged in spiral is longer and has a greater resistance than the conventional axially inserted wire. When the control device 930 drives the motor 200 in a constant voltage manner, the first wire 210 consumes less power and generates less heat, which lowers the temperature of the outer wall of the catheter 100 and reduces the risk of hemolysis when the blood contacts the catheter 100. At the same time, the power input to the motor 200 increases, and the power transmission and conversion efficiency is improved.

[0044] 7. The traditional axially threaded wire has a greater probability of receiving electromagnetic interference from other active instruments in the operating room, such as high-frequency electric knives and microwave instruments. This interference will cause induced eddy currents in the wires, resulting in unstable current input to the motor 200. The spirally configured first wire body 210 will greatly reduce the probability of receiving the above-mentioned electromagnetic interference due to the constantly changing routing method, so that the catheter assembly 900 can have better EMC compatibility even without any shielding protection, and achieve at least partial self-shielding effect. Similarly, this better EMC compatibility is also applicable to the catheter assembly 900 as an interference source to reduce electromagnetic interference to other active instruments listed above.

[0045] The spiral section 211 of the first wire body 210 is shorter than the length of the catheter 100, so that the first wire body 210 includes straight sections 212 formed at both ends of the spiral section 211, and the straight sections 212 are located in both ends of the catheter 100. The length of the spiral section 211 accounts for more than 50% of the length of the catheter 100, and further more than 80%, so that the above-mentioned effects can be fully achieved, especially providing sufficient bending resistance and avoiding twisting with the second wire body 220.

[0046] Filling material 400 is provided at both ends of the conduit 100, and the length of the filling material 400 is not less than the length of the straight section 212, so that at least the straight section 212 is wrapped therein and the straight section 212 is fixed in the conduit 100. The filling material 400 also fixes both ends of the second wire body 220 in the conduit 100, thereby making both ends of the first wire body 210 and the second wire body 220 relatively fixed in the conduit 100. The filling material 400 is formed by curing an adhesive and still has elasticity after curing, for example, epoxy resin glue with a hardness of 55D and 90A can be used.

[0047] The solution of using the filling material 400 to fix both ends of the first wire body 210 and the second wire body 220 in the catheter 100 in this embodiment has at least the following beneficial effects:

[0048] 1. Since the two ends of the catheter 100 are connected to the motor 200 and the handle 910 respectively, and the material strength of the motor 200 and the handle 910 is greater than the material strength of the catheter 100. This leads to the formation of a significant strength gradient at the connection between the catheter 100 and the motor 200 and the handle 910, and numerous tests have verified that the connection strength gradient is often the most likely place for the connection to break. By arranging elastic filling material 400 at both ends of the catheter 100, the material strength at both ends of the catheter 100 can be increased. While improving the connection strength between the catheter 100 and the motor 200 and the handle 910, a material strength transition area can be formed at the connection between the catheter 100 and the motor 200 and the handle 910, thereby weakening the strength gradient and reducing the risk of the connection between the catheter 100 and the motor 200 and the handle 910 being broken. The filling material 400 is not filled to the middle section of the catheter 100, and the existence of the first wire middle spiral section 211 is maintained (more than 50% or even 80% of the length of the catheter 100), so that the middle section of the catheter 100 maintains flexibility. The maintenance of this flexibility allows the catheter 100 to follow the direction of the blood vessels to achieve smooth intervention, and avoids the catheter 100 being too hard to bend or pierce the inner wall of the tissue.

[0049] 2. The filling material 400 is used to increase the strength of both ends of the catheter 100, so that the material strength of the slender catheter 100 changes evenly, which is particularly beneficial to the pushability of the catheter 100, avoiding bending or kinking at the strength gradient, and further protecting the second wire 220 (such as optical fiber) from damage.

[0050] 3. The straight sections 212 at both ends have poorer bendability than the spiral section 211 in the middle. The packing material 400 protects the straight sections 212, making up for the poor bendability of the straight sections 212. The middle spiral section 211 has better bendability, which just corresponds to the middle section of the catheter 100 that maintains better bendability, and is also the section where the catheter 100 bends the most during the pushing process, and can maximize its function of absorbing bending stress.

[0051] 4. If the filling material 400 is injected into the entire slender and narrow catheter 100, exhaust will become difficult. If the gas is not fully exhausted, air pockets will be formed in the cured filling material 400, resulting in uneven strength of the filling material 400. When the catheter 100 is damaged due to severe kinking, the gas in the air pockets will overflow and form gas embolism, which is extremely harmful to the patient. However, if the filling material 400 is only distributed at both ends of the catheter 100, the difficulty of injecting and curing the filling material 400 is reduced. In addition, the filling material 400 does not occupy the entire lumen of the catheter 100, and there is no need to completely exhaust the lumen of the catheter 100. In addition, when the amount of filling material 400 is small, the bubbles entrained in the filling material 400 are more likely to precipitate, which can effectively avoid the situation where air pockets are retained in the cured filling material 400. As a result, the strength of the filling material 400 after curing is more uniform, and there is no risk of air pockets forming and subsequent overflow.

[0052] 5. The filling material 400 seals both ends of the catheter 100 to prevent the gas in the catheter 100 from escaping due to disconnection between the catheter 100 and the motor 200. In addition, the gas is sealed and retained in the lumen of the catheter 100, which can maintain the pressure difference balance between the inside and outside of the catheter 100, and prevent the catheter 100 from radial expansion due to excessive internal pressure or radial contraction due to excessive internal pressure, which is very beneficial to maintaining the stability of the structure of the catheter 100, especially the radial size.

[0053] 6. As will be described below, since the length of the core liner 500 is determined by the length of the spiral section 211 of the first wire body 210, as the length of the spiral section 211 decreases, the length of the core liner 500 will also decrease. This will reduce the difficulty of making the core liner 500 (especially the hollow core liner), making it possible to prepare a core liner 500 of a required length and use the core liner 500 of this length to guide the positioning operation of the second wire body 220 in the catheter 100.

[0054] The present embodiment also provides a method for making the catheter assembly 900. Although the present embodiment provides the following method operation steps, based on conventional or no creative labor, more or fewer operation steps may be included in the method. In addition, in the steps of the method where there is no necessary causal relationship logically, the execution order of these steps is not limited to the execution order provided in the embodiment of the present application. Specifically, for example, step S20 and step S30 can be performed in a sequential order or in reverse order.

[0055] like Figures 4 to 9D As shown, the method of this embodiment mainly uses the liner core 500 to position the first wire body 210 and the second wire body 220 in the catheter 100, and specifically includes the following steps:

[0056] Step S10: spirally arrange the first wire body 210 on the outer circumferential surface of the liner core 500. Figures 4 to 6 As shown, the first wire body 210 is arranged on the liner core 500 in a manner that the first wire body 210 is wound on the liner core 500 in a spiral manner, or the first wire body 210 is pre-wound and then sleeved on the liner core 500. The pre-winding of the spiral first wire body 210 is specifically made by a twisting process, and the pitch and diameter of the spiral can be set according to requirements. When in use, the spiral first wire body 210 of the required length is cut and sleeved into the liner core 500. Further, the first wire body 210 prepared by the twisting process can be subjected to a shaping treatment so that it maintains the existing diameter and does not easily expand or collapse. This is beneficial for the first wire body 210 to be introduced into the catheter 100 and to maintain contact with the inner wall of the catheter 100 to maintain the shape of its receiving channel 110 stable, thereby making it easier to pass the second wire body 220 and not twisted with the first wire body 210 after passing.

[0057] In one embodiment, after the first wire body 210 is disposed on the liner core 500, both ends of the first wire body 210 are straightened to obtain a straight section 212, such as Fig. 7A or Fig. 8A Before the liner core 500 and the first wire body 210 are introduced into the catheter 100 together, the straight section 212 is fixed to the liner core 500 to maintain and fix the position and shape of the first wire body 210 on the liner core 500 to prevent the first wire body 210 from shifting and the spiral section 211 from loosening. The straight section 212 is fixed to the liner core 500 in a manner including but not limited to bonding, welding, heat shrink band binding, etc.

[0058] Step S20: The second wire body 220 is arranged on the liner core 500. In this embodiment, the liner core 500 can be a solid liner core or a hollow liner core. Selecting different forms of the liner core 500 will result in different ways of arranging the second wire body 220 on the liner core 500, and will affect the order of positioning the second wire body 220 in the catheter 100, which will be described in detail below.

[0059] Step S30: Introduce the liner core 500 into the catheter 100. Fig. 7A , 8AAs shown in FIG9A , in order to improve the compliance of the liner core 500 when being introduced into the catheter 100, before the liner core 500 is introduced into the catheter 100, a traction wire 600 may be inserted into the catheter 100 in advance, and one end (e.g., distal end) of the traction wire 600 is led out from one end (e.g., distal end) of the catheter 100 and connected to the liner core 500 (e.g., bonding, welding), and the other end (e.g., proximal end) is exposed outside one end (e.g., proximal end) of the catheter 100. The liner core 500 is pulled into the catheter 100 by pulling the other end of the traction wire 600. Since the first wire body 210 is fixed to the liner core 500 through the straight sections 212 at both ends, the first wire body 210 is not easy to fall off from the liner core 500 during the process of being pulled into the catheter 100.

[0060] Step S40: Pull the liner core 500 out of the catheter 100 to position the first wire body 210 and the second wire body 220 in the catheter 100. Before pulling the liner core 500 out of the catheter 100, first release the fixing between the straight section 212 and the liner core 500 to prevent the first wire body 210 that has been positioned from being taken out when the liner core 500 is pulled out.

[0061] like 7A to 7C As shown, when the liner core 500 is a solid structure, before the liner core 500 is introduced into the catheter 100, the second wire body 220 is connected to an end (e.g., distal end) of the liner core 500, and the other end (e.g., proximal end) of the liner core 500 is connected to one end (e.g., distal end) of the traction wire 600 that has been previously positioned in the catheter 100, as shown in FIG. Fig. 7A Subsequently, the other end (e.g., the proximal end) of the traction wire 600 is manipulated to be pulled toward the proximal end, and the liner core 500 together with the first wire body 210 thereon is introduced into the catheter 100, and the second wire body 220 is driven together to move toward the catheter 100 until the liner core 500 is positioned in the catheter 100, as shown in FIG. Figure 7B At this time, the traction wire 600 has been completely moved out of the catheter 100, and the second wire body 220 is close to the catheter 100 but still outside the catheter.

[0062] Subsequently, the liner core 500 is released from the traction wire 600 and the straight section 212 of the first wire body 210 (specifically, before the distal straight section 212 is about to enter the catheter 100, the distal straight section 212 is released from the liner core 500. The traction wire 600 is pulled to make the liner core 500 continue to move proximally until the proximal straight section 212 moves out of the catheter 100, and the proximal straight section 212 is released from the liner core 500. Then, the liner core 500 is released from the traction wire 600, and the first wire body 210 is pushed backward to reset, so that the proximal straight section 212 is moved back into the proximal end of the catheter 100), and the other end (for example, the proximal end) of the liner core 500 is manipulated to be pulled proximally and gradually withdrawn from the catheter 100. During this process, the second wire body 220 is pulled into the catheter 100 by the liner core 500, as shown in FIG. Figure 7C shown.

[0063] When the liner core 500 is a hollow structure, the second wire body 220 can be disposed on the liner core 500 before the liner core 500 is introduced into the catheter 100 , or can be disposed on the liner core 500 after the liner core 500 is introduced into the catheter 100 .

[0064] The first case, such as Figures 8A to 8E As shown, after the liner core 500 is introduced into the catheter 100, the second wire body 220 is inserted into the liner core 500. After the second wire body 220 is positioned in the liner core 500, the liner core 500 is removed from the catheter 100. Specifically, as shown in FIG. Fig. 8A As shown, one end (eg, the proximal end) of the liner core 500 wrapped with the first wire body 210 is fixedly connected to one end (eg, the distal end) of the traction wire 600 that has been previously positioned in the catheter 100. Figure 8B As shown, the other end (eg, the proximal end) of the traction wire 600 is manipulated to be pulled toward the proximal end, and the liner core 500 together with the first wire body 210 thereon is introduced into the catheter 100. Figure 8C As shown, the fixed connection between the liner core 500 and the traction wire 600 is released, and the liner core 500 is kept in the catheter 100. The hollow channel 510 of the hollow liner core 500 is used as a threading channel for the second wire body 220. The proximal end of the second wire body 220 is inserted into the hollow liner core 500 until the second wire body 220 is positioned in the hollow liner core 500. Fig.8D Subsequently, the hollow liner core 500 is pulled out from the catheter 100 .

[0065] The second case, such as 9A to 9C As shown, before the liner core 500 is introduced into the catheter 100, the second wire body 220 is inserted into the hollow channel 510 of the hollow liner core 500. After the hollow liner core 500 is introduced into the catheter 100, the first wire body 210 and the second wire body 220 are simultaneously introduced into the catheter 100. Specifically, as Fig. 9A As shown, the second wire body 220 is inserted into the hollow liner core 500 wrapped with the first wire body 210, and one end (e.g., the proximal end) of the hollow liner core 500 is fixedly connected to one end (e.g., the distal end) of the traction wire 600 that has been pre-positioned in the catheter 100. To prevent the second wire body 220 from escaping from the hollow liner core 500, the proximal end of the second wire body 220 can be fixed to the hollow liner core 500 by bonding, welding, etc. Fig. 9B As shown, the other end (eg, the proximal end) of the traction wire 600 is manipulated to be pulled toward the proximal end, and the liner core 500 together with the first wire body 210 thereon and the second wire body 220 therein are introduced into the catheter 100. Fig. 9CAs shown, the fixed connection between the liner core 500 and the traction wire 600 and the second wire body 220 is released, and the hollow liner core 500 is pulled out of the catheter 100 , and the first wire body 210 and the second wire body 220 are positioned in the catheter 100 .

[0066] like Fig.7D , Fig.8F and Fig.9D As shown, after the first wire body 210 and the second wire body 220 are positioned in the catheter 100 using various embodiments, adhesive is filled in both ends of the catheter 100, so that the adhesive at least seals the straight section 212 of the first wire body 210, and also seals the two ends of the second wire body 220. That is, the sealing depth of the adhesive is at least greater than the length of the straight section 212. Subsequently, a curing process such as standing and baking is performed to cure the adhesive, and a filling material 400 is obtained that wraps and fixes the straight section 212 and the two ends of the second wire body 220 therein.

[0067] Obviously, the embodiments described above are only some embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, ordinary technicians in this field can make other different forms of changes or modifications without creative work, which should fall within the scope of protection of the present invention.

Claims

1. A catheter assembly for a catheter pump, wherein the distal end of the catheter assembly is connected to a pump assembly, and the pump assembly is provided with a blood inlet and a blood outlet, characterized in that: The catheter assembly includes: a catheter, a first wire body and a second wire body inserted into the catheter; wherein at least a portion of the first wire body located in the catheter is spirally arranged to form a receiving channel extending axially; the second wire body is inserted into the receiving channel, the first wire body maintains contact with the inner wall of the catheter, and the second wire body is not in close contact with the first wire body.

2. The catheter assembly for a catheter pump according to claim 1, characterized in that Filling materials are arranged at both ends of the conduit, and the filling materials fix both ends of the first wire body and the second wire body in the conduit.

3. The catheter assembly for a catheter pump according to claim 2, characterized in that: The length of the spiral segment of the first wire body is smaller than the length of the conduit, so that the first wire body includes straight segments formed at both ends of the spiral segment, and the two straight segments are located at both ends of the conduit; the length of the filling material is not smaller than the length of the straight segment, and the straight segment is wrapped in the filling material.

4. The catheter assembly for a catheter pump according to claim 2, characterized in that: The filling material is formed by curing the adhesive and has elasticity.

5. The catheter assembly for a catheter pump according to claim 1, characterized in that: The spiral section of the first wire body abuts against the inner wall of the conduit; or the radius of the receiving channel is greater than the radial distance between the spiral section of the first wire body and the inner wall of the conduit.

6. A catheter pump, characterized in that: include: A catheter assembly for a catheter pump as described in any one of claims 1 to 5, and a pump assembly connected to the distal end of the catheter assembly, the pump assembly comprising a motor connected to the distal end of the catheter and an impeller driven by the motor to pump blood; wherein the first wire body is a conductive wire connected to the motor.

7. The catheter pump according to claim 6, characterized in that The pump assembly is provided with a sensor, and the diode includes an optical fiber connected to the sensor.

8. A method for manufacturing a catheter assembly for a catheter pump as claimed in any one of claims 1 to 5, characterized in that: include: The first wire body is spirally arranged outside the liner core; The second wire body is arranged on the lining core; introducing the liner core into the conduit; The liner core is pulled out from the conduit so that the first wire body and the second wire body are positioned in the conduit.

9. The method according to claim 8, characterized in that The lining core is a solid structure; Before the liner core is introduced into the catheter, the second wire body is connected to the end of the liner core; when the liner core is withdrawn from the catheter, the second wire body is pulled into the catheter by the liner core.

10. The method according to claim 8, characterized in that The lining core is a hollow structure; After the liner core is introduced into the catheter, that is, after the first wire body is positioned in the catheter, the second wire body is inserted into the liner core; after the liner core is withdrawn from the catheter, the second wire body is positioned in the catheter; or, Before the liner core is introduced into the catheter, the second wire body is inserted into the liner core; then, during the process of the liner core being introduced into the catheter, the second wire body and the first wire body are simultaneously introduced into the catheter by the liner core; after the liner core is pulled out of the catheter, the positioning of the first wire body and the second wire body in the catheter is completed.

11. The method according to claim 8, characterized in that Before the liner core is introduced into the catheter, a traction wire is first inserted into the catheter; one end of the traction wire is connected to the liner core, and the other end is exposed outside the catheter; the liner core is pulled into the catheter by pulling the other end of the traction wire.

12. The method according to claim 8, characterized in that After the first wire body is arranged on the liner core, two ends of the first wire body are straightened to obtain a straight section.

13. The method according to claim 12, characterized in that Before the liner core and the first wire body are introduced into the conduit together, the straight section is fixed to the liner core; before the liner core is pulled out of the conduit, the fixing relationship between the straight section and the liner core is released.

14. The method according to claim 12, characterized in that After the first wire body and the second wire body are positioned in the catheter, the method further includes: Filling adhesive into both ends of the conduit so that the adhesive at least seals the straight section; The adhesive is cured to obtain a filling material that wraps and fixes the straight section therein.

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