WO2024104184A1 - Bendable tube, blood pump, and method for manufacturing bendable tube - Google Patents

Abstract

Embodiments of the specification provide a bendable tube, comprising an inner tube, a spring tube, an outer tube, and at least one developing ring. The outer tube is coaxially arranged outside the inner tube, a spring wire of the spring tube is spirally arranged between the inner tube and the outer tube, and the developing ring is arranged between the inner tube and the outer tube. The spring tube and the developing ring are coaxially arranged in the length direction of the bendable tube, and the pitch of the spring tube at a position corresponding to the developing ring is larger than the width of the developing ring in the length direction of the bendable tube. Embodiments of the specification also provide a blood pump comprising the described bendable tube. Embodiments of the specification also provide a method for manufacturing the described bendable tube. The method comprises: sleeving the outer surface of a lining rod with the inner tube; sleeving the outer surface of the inner tube with the spring tube and the developing ring; sleeving the outer surface of the spring tube with the outer tube; and sleeving the outer tube with a heat-shrink tube, and carrying out a heat-shrink treatment process to obtain a heat-shrunk bendable tube.

Description

A bendable tube, a blood pump and a method for manufacturing the bendable tube

cross reference

This application claims priority to Chinese patent application 202211432352.5 filed on November 15, 2022, the entire contents of which are incorporated herein by reference.

Technical Field

The present specification relates to the field of medical devices, and in particular to a bendable tube, a blood pump, and a method for manufacturing the bendable tube.

Background technique

Blood pumps (e.g., catheter-intervention heart pumps) are usually used for hemodynamic maintenance. They deliver blood to specific organs through the lift generated by the fluid when the impeller rotates. They can be used to pump blood to the left ventricle, right ventricle, kidneys, and other organs. When the blood pump is applied to the heart, it can reduce the load on the ventricle, improve myocardial ischemia by increasing the blood input of the coronary artery, and enable patients to receive more complete revascularization and more thorough treatment in high-risk surgeries such as high-risk percutaneous coronary intervention (PCI). Current blood pumps are usually delivered to a specific location through a guidewire and through a blood vessel, and their auxiliary functions are realized at the specific location. When the blood pump is pushed through the patient's tortuous path or calcified anatomical structure to reach the specified location, these tortuous paths may cause damage to the blood pump components or the patient, so a flexible tube is required to provide guidance in the blood pump delivery and to withstand the load of blood on the pump housing.

Summary of the invention

One of the embodiments of the present specification provides a bendable tube, which is applied to a blood pump. The bendable tube includes an inner tube, a spring tube, an outer tube and at least one developing ring, wherein the outer tube is coaxially arranged outside the inner tube, the spring wire of the spring tube is spirally arranged between the inner tube and the outer tube, and the developing ring is arranged between the inner tube and the outer tube; the spring tube and the developing ring are coaxially arranged along the length direction of the bendable tube, and the pitch of the spring tube at the corresponding position of the developing ring is greater than the width of the developing ring along the length direction of the bendable tube.

In some embodiments, a notch is provided on the developing ring, and the spring wire of the spring tube passes through the notch.

In some embodiments, the pitch of the spring tube is unevenly distributed.

In some embodiments, the pitch of the middle portion of the spring tube is greater than the pitch of the two end portions.

In some embodiments, the outer diameters of the bendable tubes are the same, and the inner diameters at both ends of the bendable tubes are larger than the inner diameter of the middle portion of the bendable tubes; or, the inner diameters of the bendable tubes are the same, and the outer diameters at both ends of the bendable tubes are smaller than the outer diameter of the middle portion of the bendable tubes.

In some embodiments, the length of the inner tube is different from the length of the outer tube, so that two axial ends of the bendable tube form stepped connecting portions.

In some embodiments, the bendable tube further comprises a fiber channel tube, which is disposed between the inner tube and the outer tube; an inner cavity of the fiber channel tube is used for optical fibers to pass through.

In some embodiments, a notch is provided on the developing ring, and the optical fiber channel tube is disposed at a position corresponding to the notch.

One of the embodiments of the present specification provides a blood pump, which includes the bendable tube described in any of the above embodiments.

In some embodiments, the blood pump further comprises a pigtail catheter, an impeller, a motor and a catheter; the pigtail catheter is connected to the front end of the flexible tube, and a blood inlet is provided between the pigtail catheter and the flexible tube; the catheter is connected to the rear end of the flexible tube, and a blood outlet is provided between the flexible tube and the catheter; the impeller is disposed in the flexible tube, and the motor comprises a stator side and an output shaft, the output shaft is fixedly connected to the impeller, and the stator side is fixedly connected to the catheter.

One of the embodiments of the present specification provides a method for manufacturing a bendable tube, the method comprising: sleeve an inner tube on the outer surface of a liner rod; sleeve a spring tube and a developing ring on the outer surface of the inner tube; sleeve an outer tube on the outer surface of the spring tube; sleeve a heat shrink tube on the outside of the outer tube, and perform a heat shrink treatment process to obtain a bendable tube after the heat shrink treatment.

In some embodiments, the outer surface of the liner rod is provided with a polytetrafluoroethylene coating, and the method further comprises: before the inner tube is sleeved on the outer surface of the liner rod, applying silicone oil on the outer surface of the liner rod.

In some embodiments, a notch is provided on the developing ring; the method further comprises: after the spring tube and the developing ring are sleeved on the outer surface of the inner tube, the relative positions of the spring wire of the spring tube and the developing ring are adjusted so that the spring wire of the spring tube passes through the notch.

In some embodiments, the heat shrinkable tube includes a polyperfluoroethylene propylene heat shrinkable tube or a polytetrafluoroethylene heat shrinkable tube; the heat shrinking temperature in the heat shrinking treatment process is 150-250°; and the heat shrinking time in the heat shrinking treatment process is 5-20 minutes.

In some embodiments, the method also includes a shaping process; the shaping process includes: placing the bendable tube after heat shrinkage treatment into a shaping cavity of a shaping mold, and placing the shaping mold into a hot air box or a heat treatment furnace for shaping, and cooling and drying to obtain the shaped bendable tube; wherein the shaping temperature in the shaping process is 100 to 160°C; and the shaping time in the shaping process is 20 to 60 minutes.

In some embodiments, the diameters of the two end portions of the liner rod are larger than the diameter of the middle portion of the liner rod, so that the inner diameters of the two end portions of the bendable tube are larger than the inner diameter of the middle portion of the bendable tube.

In some embodiments, the method further includes: disposing the fiber channel tube between the spring tube and the inner tube; or disposing the fiber channel tube between the spring tube and the outer tube.

In some embodiments, the fiber optic channel tube is arranged between the spring tube and the inner tube. Before the spring tube and the developing ring are sleeved on the outer surface of the inner tube, the method also includes: sticking the fiber optic channel tube on the outer surface of the inner tube; sleeveing the inner tube and the fiber optic channel tube with a heat shrink tube, and performing a preliminary heat shrink treatment process.

BRIEF DESCRIPTION OF THE DRAWINGS

This specification will be further described in the form of exemplary embodiments, which will be described in detail by the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same number represents the same structure, wherein:

FIG1 is a schematic diagram of the structure of a bendable tube according to some embodiments of the present specification;

FIG2 is an enlarged schematic diagram of point A in FIG1;

Fig. 3 is a cross-sectional view taken along line B-B in Fig. 1;

FIG4 is a schematic diagram of the structure of a bendable tube according to other embodiments of the present specification;

FIG5 is a schematic structural diagram of a bendable tube according to some other embodiments of the present specification;

FIG6 is a schematic structural diagram of a bendable tube according to some other embodiments of the present specification;

Fig. 7 is a cross-sectional view taken along the line C-C in Fig. 6;

FIG8 is an enlarged schematic diagram of point D in FIG7;

FIG9A is a schematic diagram of the structure of a fiber channel tube according to some embodiments of the present specification;

FIG9B is a schematic diagram of the structure of a fiber channel tube under stress according to some embodiments of the present specification;

FIG9C is a schematic diagram of the structure of a fiber channel tube according to other embodiments of the present specification;

FIG9D is a schematic diagram of the structure of a fiber channel tube under stress according to other embodiments of the present specification;

FIG10 is a schematic diagram of the structure of a blood pump according to some embodiments of the present specification;

FIG11 is a schematic diagram of an exploded structure of a blood pump according to some embodiments of the present specification;

FIG12 is a diagram showing a use scenario of a blood pump according to some embodiments of this specification;

FIG. 13 is a schematic flow diagram of a method for manufacturing a bendable tube according to some embodiments of the present specification;

FIG. 14 is a schematic flow chart of a method for manufacturing a bendable tube according to other embodiments of the present specification;

FIG. 15 is a schematic diagram of the structure of a shaping mold according to some embodiments of the present specification.

In the figure: 10, blood pump; 100, flexible tube; 110, inner tube; 120, spring tube; 121, groove; 130, outer tube; 140, developing ring; 141, notch; 150, fiber optic channel tube; 160, optical fiber; 200, pigtail catheter; 300, inlet cage; 310, blood inlet; 400, outlet cage; 410, blood outlet; 500, impeller; 600, motor; 610, output shaft; 700, catheter; 800, pressure sensor; 20, lining rod; 30, heat shrink tube; 40, molding mold; 41, molding cavity; 1, left ventricle; 2, aortic arch.

Detailed ways

In order to more clearly illustrate the technical solutions of the embodiments of this specification, the following is a brief introduction to the drawings required for the description of the embodiments. Obviously, the drawings described below are only some examples or embodiments of this specification. For ordinary technicians in this field, without paying creative work, this specification can also be applied to other similar scenarios based on these drawings. Unless it is obvious from the language environment or otherwise explained, the same reference numerals in the figures represent the same structure or operation.

It should be understood that "installed", "connected", "connected" and "coupled" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, an indirect connection through an intermediate medium, or the internal communication of two elements. However, if other words can achieve the same purpose, the words can be replaced by other expressions.

As shown in this specification and claims, unless the context clearly indicates an exception, the words "a", "an", "an" and/or "the" do not refer to the singular and may also include the plural. Generally speaking, the terms "comprises" and "includes" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

The bendable tube in the embodiments of this specification is applied to a blood pump. An intravascular blood pump delivers blood to a specific organ through the lift generated by the fluid when the impeller rotates, and can be used to pump blood in the left ventricle, right ventricle, kidneys and other organs. A blood pump is usually delivered to a specific location through a guide wire and through a blood vessel, and performs its auxiliary function at the specific location. When the blood pump is propelled through the patient's tortuous path or calcified anatomical structure to reach the designated location, these tortuous paths may cause damage to the blood pump assembly or the patient, so a bendable tube is required to provide guidance in the blood pump delivery and to withstand the load of blood on the pump housing.

The bendable tube can be bent in a natural state, and will be elastically deformed under the action of an external force, and will return to a natural state under the action of an elastic restoring force after the external force disappears. In some embodiments, the bendable tube is arranged in the blood pump so that the bendable tube has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the bendable tube to guide the blood flow of the left ventricle into the aorta.

The bendable tube for a blood pump according to the embodiments of this specification will be described in detail below in conjunction with Figures 1 to 9D. It should be noted that the following embodiments are only used to explain the present application and do not constitute a limitation on the present application.

FIG. 1 is a schematic diagram of the structure of a bendable tube according to some embodiments of the present specification; FIG. 2 is an enlarged schematic diagram of point A in FIG. 1 .

As shown in FIG. 1 , an embodiment of the present specification provides a bendable tube 100 , which is applied to a blood pump 10 , and includes an inner tube 110 , a spring tube 120 , an outer tube 130 , and at least one developing ring 140 .

The bendable tube 100 may be a tube for guiding a blood flow path. In some embodiments, the diameter (eg, outer diameter) of the bendable tube 100 may be in the range of 4 mm to 7 mm (eg, 4 mm, 5 mm, 5.5 mm, 6 mm, 7 mm, etc.).

In some embodiments, the outer tube 130 is coaxially arranged outside the inner tube 110, and the spring wire of the spring tube 120 is spirally arranged between the inner tube 110 and the outer tube 130. In some embodiments, the inner tube 110 and the outer tube 130 can be made of polymer materials (for example, thermoplastic polyurethane elastomer, referred to as TPU), and the spring tube 120 can be a spring tube formed by spirally winding nickel-titanium wire. The three-layer structure of the inner tube 110, the spring tube 120 and the outer tube 130 is formed by heat shrinkage to form the bendable tube 100, so that the bendable tube 100 has a certain degree of flexibility to adapt to various bending angles in the blood vessel.

The developing ring 140 can be developed in an imaging device (such as an X-ray imaging device) to locate and mark the position of the bendable tube 100 in the human body. In some embodiments, the developing ring 140 can be made of a metal material, such as tantalum, platinum-iridium alloy, etc. In some embodiments, the developing ring 140 is disposed between the inner tube 110 and the outer tube 130. In some embodiments, the developing ring 140 can be bonded between the inner tube 110 and the outer tube 130 by heat shrinking. The outer surface of the bendable tube 100 prepared in this way is smooth and does not have small sharp steps, which effectively avoids the problem of hemolysis or thrombosis caused by the small sharp steps on the outer surface of the bendable tube 100.

In some embodiments, there may be only one developing ring 140, which is disposed at the maximum bending position of the bendable tube 100, so as to more accurately display the position of the bendable tube 100 in the human body and facilitate observation of the posture of the bendable tube 100 in the human body. The length direction of the tube 100 is respectively arranged at different positions to more accurately display the position and posture of the bendable tube 100 in the human body. In some embodiments, the specific number and position of the developing ring 140 can be set according to different surgical requirements.

In some embodiments, as shown in FIGS. 1-2 , the spring tube 120 and the developing ring 140 are coaxially arranged along the length direction of the bendable tube 100, and the pitch of the spring tube 120 at the corresponding position of the developing ring 140 is greater than the width of the developing ring 140 along the length direction of the bendable tube 100. In some embodiments, the ratio of the pitch of the spring tube 120 at the corresponding position of the developing ring 140 to the width of the developing ring 140 along the length direction of the bendable tube 100 may be 1.1 to 3 times. In some embodiments, the ratio of the pitch of the spring tube 120 at the corresponding position of the developing ring 140 to the width of the developing ring 140 may be 1.5 to 2.6 times. In some embodiments, the ratio of the pitch of the spring tube 120 at the corresponding position of the developing ring 140 to the width of the developing ring 140 along the length direction of the bendable tube 100 may be 1.9 to 2.2 times.

In some embodiments, as shown in FIG2 , the diameter of the spring wire of the spring tube 120 may be greater than or equal to the thickness of the developing ring 140. The developing ring 140 is at least partially disposed between two adjacent spring wires of the spring tube 120 to keep the outer surface of the bendable tube 100 flat and smooth, to avoid unnecessary protrusions on the outer surface of the bendable tube 100, and to prevent hemolysis or thrombosis caused by the uneven outer surface of the bendable tube 100.

FIG3 is a cross-sectional view taken along the B-B direction in FIG1 . In some embodiments, a notch 141 is provided on the developing ring 140, and the width of the notch 141 is greater than the cross-sectional width of the spring wire of the spring tube 120, and the spring wire of the spring tube 120 passes through the notch 141. Since the spring wire of the spring tube 120 is spirally disposed on the outer surface of the inner tube 110, the cross-section of the spring wire in the B-B direction is elliptical, and the cross-sectional width of the spring wire refers to the maximum width of the spring wire at the cross-section in the B-B direction. By arranging both the spring tube 120 and the developing ring 140 between the inner tube 110 and the outer tube 130, the developing ring 140 is clamped between two adjacent spring wires of the spring tube 120, and the spring wire passes through the notch 141, the thickness of the bendable tube 100 in the radial direction at the corresponding position of the developing ring 140 can be reduced, and unnecessary protrusions can be avoided from forming on the outer surface of the bendable tube 100.

In some embodiments, the pitch of the spring tube 120 is unevenly distributed. In some embodiments, the pitch of the spring tube 120 is related to the bending angle thereof. The larger the pitch of the spring tube 120, the larger the bending angle. In some embodiments, the pitch of the spring tube 120 is also related to the strength of the bendable tube 100. The smaller the pitch of the spring tube 120, the higher the strength of the bendable tube 100. Therefore, the pitch of the spring tube 120 can be designed to be unevenly distributed according to different surgical requirements.

In some embodiments, the pitch of the middle part of the spring tube 120 is greater than the pitch of the two end parts. In some embodiments, the middle part of the spring tube 120 may be a part from 1/4 of one end to 1/4 of the other end. In some embodiments, the middle part of the spring tube 120 may be a part within a preset length from the midpoint (for example, a part within 1/3 of each end from the midpoint of the spring tube 120). In some embodiments, the part other than the middle part of the spring tube 120 may be the two end parts. In some embodiments, the pitch of the middle part of the spring tube 120 may be the average pitch of the middle part; the pitch of the two end parts of the spring tube 120 may be the average pitch of the two end parts. As shown in FIG12, during the left ventricular intervention surgery of the blood pump 10, the bendable tube 100 extends into the left ventricle 1, and the bending angle of the middle part of the bendable tube 100 is the largest. Then, the spring tube 120 at the corresponding position of the maximum bending should be set with a larger pitch to adapt to the bending angle of the bendable tube 100. The bending angles of the two ends of the bendable tube 100 are relatively small (e.g., close to a straight line), and the two ends of the bendable tube 100 can be connected to two front and rear parts (as shown in FIG. 10 , the front end is connected to the inlet chuck 300, and the rear end is connected to the outlet chuck 400). If the two ends of the bendable tube 100 require higher strength, the spring tube 120 at the corresponding positions of the two ends of the bendable tube 100 can be set with a smaller pitch.

In some embodiments, the pitch of one end of the spring tube 120 is smaller than the pitch of other parts. For example, the outlet saddle 400 can be integrally formed with the bendable tube 100, and the pitch of the front end of the spring tube 120 is smaller than the pitch of other parts. Since the front end of the spring tube 120 needs to be connected to the inlet saddle 300, the front end of the spring tube 120 is set with a smaller pitch to improve the strength of the connection section to ensure connection stability and sealing.

In some embodiments, the outer diameters of the bendable tube 100 are the same, and the inner diameters of the two ends of the bendable tube 100 are larger than the inner diameter of the middle part of the bendable tube 100. The two ends of the bendable tube 100 may form a stepped hole connection section, and the outer surface of the parts connected to the front and rear ends of the bendable tube 100 may be provided with a matching stepped shaft connection section. After the two ends of the bendable tube 100 are connected to the front and rear parts, the inner and outer surfaces of the bendable tube 100 and the front and rear parts are aligned. As shown in Figures 10 and 11 As shown, the front end of the bendable tube 100 is connected to the inlet chuck 300, and the rear end is connected to the outlet chuck 400. In some embodiments, the blood inlet 310 is provided on the inlet chuck 300, and the inlet chuck 300 is in a grid shape, which can prevent the heart tissue (such as the chordae tendineae of the mitral valve) from being sucked into the bendable tube 100, and prevent the ventricular wall from blocking the blood flow inlet due to negative pressure, resulting in overload of the motor 600. In some embodiments, the inlet chuck 300 can be made of metal material or polymer material. In some embodiments, at least part of the outlet chuck 400 is in a grid shape, forming a blood outlet 410, which can adjust the direction of blood flowing out of the blood outlet 410. In some embodiments, the outlet chuck 400 can be integrally formed with the bendable tube 100, that is, a plurality of incisions are provided on the side wall at the rear end of the bendable tube 100 to form the outlet chuck 400. In some embodiments, the outlet chuck 400 can be a component independent of the bendable tube 100, and is fixed to the rear end of the bendable tube 100 by means of snap-fitting, welding, bonding, etc. In some embodiments, the outlet chuck 400 may be made of metal material or polymer material.

In some embodiments, the inner diameters of the bendable tube 100 are the same, and the outer diameters of the two end portions of the bendable tube 100 are smaller than the outer diameter of the middle portion of the bendable tube 100. The two ends of the bendable tube 100 may form a stepped shaft connection section, and the inner surfaces of the inlet chuck 300 and the outlet chuck 400 may be provided with a stepped hole connection section matching therewith. After the two ends of the bendable tube 100 are connected to the inlet chuck 300 and the outlet chuck 400, the inner and outer surfaces of the bendable tube 100 and the inlet chuck 300 and the outlet chuck 400 are aligned.

In some embodiments, the length of the inner tube 110 is different from the length of the outer tube 130, so that the two axial ends of the bendable tube 100 form a stepped connection portion. The stepped connection portion can be a stepped hole connection section, or the stepped connection portion can be a stepped shaft connection section. In some embodiments, the two ends of the bendable tube 100 can be fixedly connected to the inlet chuck 300 and the outlet chuck 400 respectively by means of clamping, welding, bonding, etc.

Fig. 4 is a schematic diagram of the structure of a bendable tube according to other embodiments of the present specification. In some embodiments, as shown in Fig. 4, the inner tube 110 is longer than the outer tube 130, and the length of the spring tube 120 is the same as that of the inner tube 110, so that the axial ends of the bendable tube 100 form stepped shaft connection sections.

Fig. 5 is a schematic diagram of the structure of a bendable tube according to some other embodiments of the present specification. In some embodiments, as shown in Fig. 5, the outer tube 130 is longer than the inner tube 110, and the length of the spring tube 120 is the same as that of the outer tube 130, so that the axial ends of the bendable tube 100 form a stepped hole connection section.

FIG6 is a schematic diagram of the structure of a bendable tube according to some other embodiments of the present specification; FIG7 is a cross-sectional view taken along the C-C axis in FIG6; and FIG8 is an enlarged schematic diagram of D in FIG7. In some embodiments, as shown in FIG6, FIG7 and FIG8, the bendable tube 100 further includes a fiber channel tube 150, which is disposed between the inner tube 110 and the outer tube 130. The inner cavity of the fiber channel tube 150 is used for passing an optical fiber 160. The inner diameter of the fiber channel tube 150 is greater than the outer diameter of the optical fiber 160, and the optical fiber 160 is inserted into the fiber channel tube 150 through a traction wire. The optical fiber 160 is a medium for data and signal transmission, and can be used to realize signal connection between a pressure sensor (e.g., the pressure sensor 800 described below) disposed in the blood pump 10 and an external controller. Generally, the pressure sensor used in the blood pump 10 is an optical fiber pressure sensor. The optical fiber of the optical fiber pressure sensor is usually made of glass fiber, which is brittle and easy to break. When the blood pump 10 is pushed through the patient's tortuous path or calcified anatomical structure to reach the designated position, the optical fiber 160 is easily damaged, resulting in damage to the insulation layer of the optical fiber 160, which reduces the life of the optical fiber 160 or makes it unusable. At the same time, the commonly used bonding method of the blood pump sensor is to bond the optical fiber of the pressure sensor to the outside of the bendable tube 100, which increases the size of the entire device and affects the blood flow movement. The embodiment of this specification minimizes the effect of the optical fiber 160 on the blood flow movement by placing the optical fiber 160 inside the bendable tube 100 without increasing the size of the device, and at the same time changes the placement of the optical fiber 160 to reduce the force on the optical fiber 160 when the bendable tube 100 is bent, thereby increasing the service life of the optical fiber 160.

In some embodiments, the inner diameter of the fiber channel tube 150 is 1.1 to 3 times the outer diameter of the optical fiber 160. In some embodiments, the inner diameter of the fiber channel tube 150 is 1.4 to 2.6 times the outer diameter of the optical fiber 160. The inner diameter of the fiber channel tube 150 is 1.8 to 2.2 times the outer diameter of the optical fiber 160. The inner cavity of the fiber channel tube 150 is not only for the optical fiber 160 to pass through, but the fiber channel tube 150 can also provide a certain activity space for the optical fiber 160, so that when the bendable tube 100 is subjected to external force, the optical fiber 160 can be deformed within a certain space range, such as the optical fiber 160 can be appropriately stretched, but will not be damaged, thereby increasing the service life of the optical fiber 160.

In some embodiments, as shown in FIG. 6 , the fiber channel tube 150 is disposed along the length direction of the bendable tube 100. The side of the bendable tube 100 that bends inward when it is bent. Since the side of the bendable tube 100 that bends inward has relatively more blood flow during surgery, arranging the fiber channel tube 150 and the pressure sensor on this side can better monitor the pressure. Arranging the fiber channel tube 150 on the side of the bendable tube 100 can also reduce the deformation of the optical fiber 160 when it is bent (such as the elongation of the optical fiber 160 when the fiber channel tube 150 is bent).

In some embodiments, the developing ring 140 is provided with a notch 141, and the setting position of the fiber channel tube 150 corresponds to the notch 141. In some embodiments, when the fiber channel tube 150 is set inside the spring tube 120, the fiber channel tube 150 passes through the notch 141 (not shown in the figure). In other embodiments, when the fiber channel tube 150 is set outside the spring tube 120, it can be set radially outside the notch 141 (not shown in the figure). By making the setting position of the fiber channel tube 150 correspond to the notch 141 on the developing ring 140, the axial thickness of the flexible tube 100 at the corresponding position of the developing ring 140 and the fiber channel tube 150 can be reduced, and unnecessary protrusions can be avoided on the outer surface of the flexible tube 100, so as to prevent hemolysis or thrombosis caused by the uneven outer surface of the flexible tube 100.

In some embodiments, the bendable tube 100 may be provided with only the developing ring 140 without the fiber channel tube 150, or only the fiber channel tube 150 without the developing ring 140. In some embodiments, the bendable tube 100 may be provided with both the developing ring 140 and the fiber channel tube 150.

In some embodiments, the fiber channel tube 150 is disposed between the spring tube 120 and the outer tube 130. In some embodiments, the spring tube 120 may be provided with a groove 121, the groove 121 being opened along the axial direction of the spring tube 120, and the fiber channel tube 150 is partially embedded in the groove 121. As shown in FIGS. 6 and 7, the groove 121 may be opened on the outer circumference of the spring tube 120. In some embodiments, the fiber channel tube 150 is disposed between the spring tube 120 and the inner tube 110. The groove 121 may be opened on the inner circumference of the spring tube 120 (not shown in the figure). In some embodiments, the spring tube 120 may further open an axial groove 121 on its outer circumference or inner circumference after the spring wire is spirally formed. The opening of the groove 121 may be processed by a rod milling cutter, end milling or laser cutting.

In some embodiments, the fiber channel tube 150 may be attached to the inner surface or the outer surface of the spring tube 120. In some embodiments, a groove for accommodating the fiber channel tube 150 may be provided on the outer surface of the inner tube 110 or the inner surface of the outer tube 130. In this embodiment, the thickness of the inner tube 110 and/or the outer tube 130 is greater than the outer diameter of the fiber channel tube 150.

In some embodiments, the fiber channel tube 150 can be arranged in a spiral shape along the length direction of the bendable tube 100, and its spiral direction is the same as the spiral direction of the spring wire of the spring tube 120. In some embodiments, the fiber channel tube 150 can be arranged in a spiral shape along the gap of the spring wire of the spring tube 120. The optical fiber 160 passes through the spiral fiber channel tube 150, so that the optical fiber 160 can also be spiral, so as to increase the deformation margin of the optical fiber 160. This structure allows the optical fiber 160 to be appropriately stretched when the bendable tube 100 passes through the patient's tortuous or calcified anatomical structure to reach a predetermined position, and can reduce the force on the optical fiber 160 when the bendable tube 100 is bent, so that the optical fiber 160 will not be damaged when it is deformed.

FIG. 9A is a schematic diagram of the structure of a fiber channel tube according to some embodiments of the present specification; FIG. 9B is a schematic diagram of the structure of a fiber channel tube under stress according to some embodiments of the present specification.

In some embodiments, the optical fiber 160 can be pre-shaped into a curved shape that can increase the deformation margin, for example, the optical fiber 160 can be S-shaped, wavy or spiral. The pre-shaping of the optical fiber 160 refers to the pre-shaping of the originally linear optical fiber 160 into an S-shape, wavy or spiral shape, which can be pre-shaped manually or by tooling. As shown in FIG9A, the optical fiber 160 is in an S-shaped curved shape. When the bendable tube 100 is assembled for the blood pump, the front end of the optical fiber 160 is bonded with a traction wire. After the optical fiber 160 passes through the optical fiber channel tube 150, the traction wire is removed, so that the optical fiber 160 can maintain an S-shaped curved shape in a natural state in the optical fiber channel tube 150. When the optical fiber 160 of this structure reaches the predetermined position through the patient's tortuous or calcified anatomical structure, the optical fiber 160 can be appropriately stretched, which can reduce the force on the optical fiber 160 when the bendable tube 100 is bent, as shown in FIG9B.

FIG. 9C is a schematic diagram of the structure of a fiber channel tube according to other embodiments of the present specification; FIG. 9D is a schematic diagram of the structure of a fiber channel tube under stress according to other embodiments of the present specification. In some embodiments, as shown in FIG. 9C , the predetermined bending angle of the optical fiber 160 is greater than the predetermined bending angle of the bendable tube 100. In some embodiments, as shown in FIG. 9D , the predetermined bending angle of the optical fiber 160 can be the same as the maximum bending angle of the bendable tube 100. After the blood pump passes through the aortic arch and enters the left ventricle, the optical fiber 160 can bend together with the bendable tube 100, thereby reducing the risk of the optical fiber 160 bending. Excessive bending may cause the insulation layer to be damaged, which may reduce the life of the optical fiber 160 or make it unusable.

In some embodiments, the predetermined bending angle of the optical fiber 160 can be determined according to the expected bending angle of the bendable tube 100. If the expected bending angle of the bendable tube 100 is large, the predetermined bending shape of the optical fiber 160 can be an S-shape for the entire optical fiber 160; if the expected bending angle of the bendable tube 100 is small, the predetermined bending shape of the optical fiber 160 can be an S-shape corresponding to the bent section of the bendable tube 100, and a straight shape corresponding to the straight section of the bendable tube 100.

In some embodiments, the bendable tube 100 can be prepared by casting, and the fiber channel tube 150 is formed by using a mold during the casting process. For example, when the bendable tube 100 is cast, a long steel rod is added at the position of the fiber channel tube 150, and the fiber channel tube 150 can be formed by removing the steel rod after casting.

In some embodiments, the bendable tube 100 is formed by heat shrinking, and the fiber channel tube 150 is formed by pre-embedded channel tube. In some embodiments, the fiber channel tube 150 can be a polyimide tube (PI tube for short). The specific heat shrinking molding manufacturing method of the bendable tube 100 is described below.

The blood pump involved in the embodiments of this specification will be described in detail below in conjunction with Figures 10 and 11. Figure 10 is a schematic diagram of the structure of a blood pump according to some embodiments of this specification; Figure 11 is a schematic diagram of the exploded structure of a blood pump according to some embodiments of this specification.

The blood pump 10 may include a flexible tube as described in any embodiment of the present specification. As shown in Figures 10 and 11, the blood pump 10 also includes a pigtail catheter 200, a blood inlet 310, a blood outlet 410, an impeller 500, a motor 600 and a catheter 700. The pigtail catheter 200 is connected to the front end of the flexible tube 100, and a blood inlet 310 is provided between the pigtail catheter 200 and the flexible tube 100. The catheter 700 is connected to the rear end of the flexible tube 100, and a blood outlet 410 is provided between the flexible tube 100 and the catheter 700. The impeller 500 is arranged in the flexible tube 100, and the motor 600 includes a stator side and an output shaft 610, the output shaft 610 is fixedly connected to the impeller 500, and the stator side is fixedly connected to the catheter 700. Among them, the front end in the embodiment of the present specification refers to the end that first enters the human body during surgery, and the rear end refers to the end that enters the human body later during surgery.

In some embodiments, the blood pump 10 further includes a pressure sensor 800. The pressure sensor 800 includes, but is not limited to, a piezoelectric pressure sensor, a piezoresistive pressure sensor, an electromagnetic pressure sensor, a capacitive pressure sensor, and the like.

In some embodiments, the pressure sensor 800 is disposed at the front end of the bendable tube 100, and the pressure sensor 800 can be used to detect the blood perfusion pressure at the front end of the bendable tube 100. In some embodiments, if the bendable tube 100 is inserted into the left ventricle 1, as shown in FIG12, when the blood pump enters the left ventricle 1, the bendable tube 100 guides the blood pump to cross the aortic arch 2 and reach the left ventricle 1, and the pressure sensor 800 can be used to detect the blood perfusion pressure in the left ventricle. In some embodiments, if the bendable tube 100 is inserted into the aorta, the pressure sensor 800 can be used to detect the perfusion pressure in the aorta. In some embodiments, the setting position of the pressure sensor 800 is closer to the front end of the blood pump 10 relative to the blood inlet 310 (as shown in FIG10 and FIG11).

In some embodiments, the blood pump 10 further includes a second pressure sensor (not shown in the figure), which is disposed at the rear end of the flexible tube 100. By adding the pressure sensor 800 and/or the second pressure sensor at the blood inlet 310 and/or the blood outlet 410 of the blood pump 10, the left ventricular and aortic pressures can be monitored in real time, and the working state of the blood pump 10 can be conveniently known.

In some embodiments, the second pressure sensor is disposed at the rear end of the bendable tube 100, and the second pressure sensor can be used to detect the blood perfusion pressure at the rear end of the bendable tube 100. The blood perfusion pressure at the rear end of the bendable tube 100 can be the blood pressure after the blood is pressurized by the bendable tube 100, the impeller 500 and other components.

In some embodiments, the pressure sensor 800 transmits signals through the optical fiber 160 in the optical fiber channel tube 150. One end of the optical fiber 160 is connected to the pressure sensor 800 signal, and the other end is connected to the external controller signal. The controller can receive the first pressure signal of the pressure sensor 800 through the optical fiber 160.

According to the structure of the blood pump 10 in the above embodiment, it can be inserted into tissues and organs such as the heart or blood vessels, and the impeller 500 can increase the perfusion pressure of the heart or blood vessels, thereby increasing the heart's pumping function and reducing the burden on the heart. By providing the bendable tube 100, the bendable tube 100 has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the bendable tube 100 to guide the blood flow of the left ventricle into the aorta.

FIG. 13 is a schematic flow chart of a method for manufacturing a bendable tube according to some embodiments of the present specification; FIG. 14 is a schematic flow chart of a method for manufacturing a bendable tube according to other embodiments of the present specification.

As shown in FIG. 13 and FIG. 14 , some embodiments of the present specification provide a method for manufacturing a bendable tube, and a process 1000 of the method for manufacturing a bendable tube may include the following steps.

Step 1100, sleeve the inner tube 110 on the outer surface of the liner rod 20. The liner rod 20, which can also be called a core shaft, can be a metal rod (for example, a long cylindrical rod made of stainless steel, titanium, aluminum alloy, etc.). The inner tube 110 can be made of polyurethane material (TPU for short), and TPU of different hardness can be selected according to needs (for example, TPU with a hardness range of 60A to 92A).

In some embodiments, the outer surface of the liner rod 20 is provided with a polytetrafluoroethylene coating (PTFE for short), and the PTFE coating can reduce the friction between the inner tube 110 and the liner rod 20. Step 1100 may also include steps 1110 and 1120. Step 1110, applying silicone oil on the outer surface of the liner rod 20. Lubricating the liner rod 20 with silicone oil can further reduce friction and facilitate the flexible tube 100 to fall off from the liner rod 20 after heat shrinkage. Step 1120, sleeve the inner tube 110 on the outer surface of the liner rod 20. The inner diameter of the inner tube 110 can be slightly larger than the outer diameter of the liner rod 20, so as to facilitate sleeve the inner tube 110 on the outside of the liner rod 20.

Step 1200: sleeve the spring tube 120 and the developing ring 140 on the outer surface of the inner tube 110. In some embodiments, the spring tube 120 and the developing ring 140 can be sleeved on the outer surface of the inner tube 110 simultaneously or successively.

In some embodiments, step 1200 may include step 1210 and step 1220. Step 1210, bonding or clamping the developing ring 140 to the expected position of the inner tube 110. The expected position refers to the corresponding position of the developing ring 140 on the inner tube 110 after the bendable tube 100 is manufactured and formed by heat shrinking. In some embodiments, a notch 141 is provided on the developing ring 140, so that the developing ring 140 has a certain amount of deformability, which facilitates the developing ring 140 to be quickly put on the outer surface of the inner tube 110 (for example, under the action of external force, the notch 141 can be slightly opened to expand the inner diameter of the developing ring 140, which is convenient for putting on the inner tube 110). In some embodiments, the developing ring 140 can be bonded to the TPU inner tube by glue or other means for positioning, and maintain a certain stability to avoid displacement during hot melting.

Step 1220, the spring wire of the spring tube 120 is sleeved on the outer surface of the inner tube 110. In some embodiments, after the spring wire of the spring tube 120 is sleeved on the outer surface of the inner tube 110, the spring wire can be dispersed to avoid the local bending of the spring tube 120 during the force process. The spring wire can preferably be a shape memory material (for example: nickel-titanium alloy, copper-aluminum alloy, etc.). In some embodiments, the inner diameter of the spring tube 120 formed by the spring wire can be slightly smaller than the outer diameter of the inner tube 110 to avoid the spring wire of the spring tube 120 from being loose after being installed on the outer surface of the inner tube 110. At this time, the pitch of the spring tube 120 can also be manually adjusted to make the pitch of the spring tube 120 evenly distributed or unevenly distributed.

In some embodiments, after the spring tube 120 is sleeved on the outer surface of the inner tube 110, the pitch of the spring tube 120 can be adjusted to make the pitch uniform or uneven. For example, in one of the above embodiments, the pitch of the middle part of the spring tube 120 is greater than the pitch of the two end parts. Then, after the spring tube 120 is sleeved on the outer surface of the inner tube 110, the pitch of the spring tube 120 is adjusted according to the bending requirements of the bendable tube 100 to meet the requirements of uneven pitch. For another example, when it is required that any position of the entire bendable tube 100 can be bent, the pitch of the spring tube 120 can be adjusted to a uniform pitch.

In some embodiments, the diameter of the spring wire of the spring tube 120 is greater than or equal to the thickness of the developing ring 140. When placing the spring wire, the spring wire and the developing ring 140 can be staggered to avoid forming unnecessary protrusions.

Step 1300, sleeve the outer tube 130 on the outer surface of the spring tube 120. The outer tube 130 can be made of polyurethane material (TPU for short), and TPUs of different hardnesses can be selected as needed (for example, TPUs with a hardness range of 60A to 92A). In some embodiments, the inner diameter of the outer tube 130 can be slightly larger than the outer diameter of the spring tube 120, so that the outer tube 130 can be smoothly sleeved on the outer surface of the spring tube 120 without damaging the adjusted pitch of the spring tube 120.

Step 1400 may include step 1410 and step 1420. Step 1410: Cover the outer tube 130 with a heat shrink tube 30 and perform a heat shrinking process to obtain a heat-shrinkable bendable tube 100. Step 1420: After heat shrinking, remove the heat shrink tube 30 and the lining rod 20 in the inner tube 110.

The heat shrink tube 30 is mainly used to transfer heat and pressurize the inner tube 110 and the outer tube 130 by shrinking itself, so that the inner tube 110 and the outer tube 130 can be melted by heat and then, under the action of pressure, the inner tube 110, the spring tube 120 and the outer tube 130 can be integrated into a structure. In some embodiments, the heat shrink tube 30 can be made of polytetrafluoroethylene (FEP) or polytetrafluoroethylene (PTFE). Materials. In some embodiments, step 1410 performs a heat shrinking process by hot air equipment, rheoforming machines and other equipment. In some embodiments, the heat shrinking temperature in the heat shrinking process is 150-250°. The heat shrinking time in the heat shrinking process is 5-20 minutes. In some embodiments, the heat shrinking temperature in the heat shrinking process is 180-230°. The heat shrinking time in the heat shrinking process is 7-18 minutes. In some embodiments, the heat shrinking temperature in the heat shrinking process is 190-220°. The heat shrinking time in the heat shrinking process is 10-16 minutes. In some embodiments, the heat shrinking temperature in the heat shrinking process is 200-215°. The heat shrinking time in the heat shrinking process is 12-15 minutes.

In some embodiments, the manufacturing method of the bendable tube further includes a shaping process. The shaping process includes: as shown in FIG15, placing the bendable tube 100 after heat shrinkage treatment into the shaping cavity 41 of the shaping mold 40, and placing the shaping mold 40 into a hot air box or a heat treatment furnace for shaping, and cooling and drying to obtain the shaped bendable tube 100. In some embodiments, the shaping temperature in the shaping process is 100 to 160°C. In some embodiments, the shaping time in the shaping process is 20 to 60 minutes. As shown in FIG15, a plurality of shaping cavities 41 can be opened on the shaping mold 40, and a plurality of bendable tubes 100 can be shaped at the same time to improve production efficiency.

In some embodiments, in order to manufacture a variable diameter bendable tube 100, a variable diameter liner rod 20 can be used. In some embodiments, the diameter of the two end portions of the liner rod 20 is greater than the diameter of the middle portion of the liner rod 20, so that the inner diameter of the two end portions of the obtained bendable tube 100 is greater than the inner diameter of the middle portion of the bendable tube 100, and the two end portions of the bendable tube 100 form stepped holes. In this embodiment, in order to facilitate the removal of the liner rod 20 from the inner tube 110 in the subsequent process, the liner rod 20 can be set into a multi-section combination according to different diameters. For example, the two sections with larger diameters at the two end portions of the liner rod 20 can be detachably connected to the middle section. In step 1100, the inner tube 110 is first sleeved on the middle section of the liner rod 20 with a smaller diameter, and then the two sections with larger diameters at the two end portions are connected to the middle section to assemble into a complete liner rod 20. In step 1420, the two sections at the two end portions of the liner rod 20 are first removed, and then the middle section of the liner rod 20 is taken out.

In some embodiments, the diameter of the two ends of the liner rod 20 is smaller than the diameter of the middle part of the liner rod 20, so that the outer diameter of the two ends of the bendable tube 100 is smaller than the outer diameter of the middle part of the bendable tube 100, and the two ends of the bendable tube 100 form a stepped axis.

In some embodiments, in order to manufacture a bendable tube 100 with a variable diameter, an inner tube 110 and/or an outer tube 130 with different thicknesses in the radial direction may be used, so that a bendable tube 100 with a variable diameter is obtained after heat shrinkage. For example, an outer tube 130 with a thick middle portion and thin end portions may be used, so that the outer diameter of the end portions of the bendable tube 100 obtained is smaller than the outer diameter of the middle portion of the bendable tube 100, and the end portions of the bendable tube 100 form a stepped shaft.

In some embodiments, a spring tube 120 with a variable diameter can also be used to manufacture a bendable tube 100 with a variable diameter. For example, according to the expected demand for the bendable tube 100 with a variable diameter, the diameter of the spring tube 120 at different axial positions can be changed when the spring tube 120 is made by spirally winding the spring wire. In some embodiments, a spring tube 120 with an outer diameter at both ends smaller than the outer diameter at the middle portion can be manufactured to manufacture a bendable tube 100 with an outer diameter at both ends smaller than the outer diameter at the middle portion. In some embodiments, a spring tube 120 with an inner diameter at both ends larger than the outer diameter at the middle portion can be manufactured to manufacture a bendable tube 100 with an inner diameter at both ends larger than the outer diameter at the middle portion.

In some embodiments, the method for manufacturing the bendable tube 100 further includes: disposing the fiber channel tube 150 between the spring tube 120 and the inner tube 110 ; or disposing the fiber channel tube 150 between the spring tube 120 and the outer tube 130 .

In some embodiments, the optical fiber channel tube 150 is formed by pre-embedded tube during the manufacturing process of the bendable tube 100 , and the pre-embedded tube may be a polyimide tube (PI tube for short).

In some embodiments, the fiber channel tube 150 is disposed between the spring tube 120 and the inner tube 110. Before the spring tube 120 and the developing ring 140 are sleeved on the outer surface of the inner tube 110 (i.e., before step 1200), the fiber channel tube 150 is first pasted on the outer surface of the inner tube 110. In some embodiments, a groove for accommodating the embedded tube can be provided along the axial direction on the outer surface of the inner tube 110. The groove can be a groove matching the embedded tube, or a groove having a width greater than or less than the diameter of the embedded tube. By using the groove as the accommodating space for the embedded tube, it is possible to avoid or reduce the situation in which the thickness of the bendable tube 100 corresponding to the embedded tube increases due to the embedded tube, thereby causing the outer surface to be uneven.

In some embodiments, the fiber channel tube 150 is disposed between the spring tube 120 and the outer tube 130. In this case, the spring tube 120 and the developing ring 140 can be sleeved on the outer surface of the inner tube 110, and then the fiber channel tube 150 can be pasted on the inner tube 110. On the outer surface of the spring tube 120 or the inner surface of the outer tube 130, and then perform steps 1300 and 1400.

In some embodiments, a groove for accommodating the embedded pipe may be provided along the axial direction on the inner surface of the outer tube 130. The groove may be a groove matching the embedded pipe, or a groove having a width greater than or less than the diameter of the embedded pipe. By using the groove as the accommodating space for the embedded pipe, it is possible to avoid or reduce the situation where the thickness of the bendable pipe 100 corresponding to the embedded pipe increases due to the embedded pipe, thereby causing the outer surface to be uneven.

In some embodiments, grooves for accommodating the embedded tubes may also be provided on the inner surface and the outer surface of the spring tube 120 .

In some embodiments, one end of the fiber channel tube 150 near the pressure sensor 800 is sealed and connected to the pressure sensor 800, the optical fiber 160 in the fiber channel tube 150 is electrically connected to the pressure sensor 800, and the portion of the other end of the fiber channel tube 150 extending out of the bendable tube can be disposed on a subsequent structure (such as the motor 600, the catheter 700), for example, the subsequent fiber channel tube 150 can be disposed inside or outside the subsequent structure of the blood pump 10. The second pressure sensor can be connected to another optical fiber, which can also be disposed in the fiber channel tube 150 and located inside or outside the subsequent structure of the blood pump 10.

In some embodiments, the fiber channel tube 150 is disposed between the spring tube 120 and the inner tube 110. Before the spring tube 120 and the developing ring 140 are sleeved on the outer surface of the inner tube 110, the fiber channel tube 150 can be pasted on the outer surface of the inner tube 110, and then the heat shrink tube 30 is sleeved on the outer surface of the inner tube 110 and the fiber channel tube 150, and a preliminary heat shrink treatment process is performed. Through the preliminary heat shrink treatment process, the fiber channel tube 150 is pasted on the outer surface of the inner tube 110. After the preliminary heat shrink treatment process, the heat shrink tube 30 is removed and step 1200 is continued.

In some embodiments, the fiber channel tube 150 can also be glued to the outer surface of the inner tube 110 to facilitate shaping and maintain relative stability. After the fiber channel tube 150 is glued, no preliminary heat shrinking process is required, and step 1200 can be performed directly.

The beneficial effects that may be brought about by the embodiments of the present specification include but are not limited to: 1) In the bendable tube of the embodiment of the present specification, the developing ring 140 is arranged between the inner tube 110 and the outer tube 130. This structural design makes the outer surface of the bendable tube 100 smooth without the problem of small sharp steps, effectively avoiding the problem of hemolysis or thrombosis caused by the small sharp steps on the outer surface of the bendable tube 100; 2) In the bendable tube of the embodiment of the present specification, by arranging the optical fiber inside the bendable tube 100, the size of the device is reduced, and the influence of the optical fiber on the blood flow movement is minimized; 3) In the bendable tube of the embodiment of the present specification, when experiencing certain special anatomical structures, such as tortuous paths or calcification, the optical fiber can be appropriately stretched, but will not be damaged, which can effectively extend the service life of the optical fiber; 4) The variable diameter structure design of the two end parts of the bendable tube 100 can eliminate the steps at the connection and avoid the phenomenon of hemolysis or thrombosis; 5) The manufacturing method of the bendable tube of the embodiment of the present specification has a simple processing method and controllable processing steps, which can effectively improve production efficiency.

The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only for example and does not constitute a limitation of this specification. Although not explicitly stated here, those skilled in the art may make various modifications, improvements and corrections to this specification. Such modifications, improvements and corrections are suggested in this specification, so such modifications, improvements and corrections still belong to the spirit and scope of the exemplary embodiments of this specification.

At the same time, this specification uses specific words to describe the embodiments of this specification. For example, "one embodiment", "an embodiment", and/or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that "one embodiment" or "an embodiment" or "an alternative embodiment" mentioned twice or more in different positions in this specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of this specification can be appropriately combined.

Finally, it should be understood that the embodiments described in this specification are only used to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, as an example and not a limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly introduced and described in this specification.

Claims (18)

1. A bendable tube, applied to a blood pump, characterized in that it comprises an inner tube (110), a spring tube (120), an outer tube (130) and at least one developing ring (140), wherein the outer tube (130) is coaxially arranged outside the inner tube (110), a spring wire of the spring tube (120) is spirally arranged between the inner tube (110) and the outer tube (130), and the developing ring (140) is arranged between the inner tube (110) and the outer tube (130);

   The spring tube (120) and the developing ring (140) are coaxially arranged along the length direction of the bendable tube, and the pitch of the spring tube (120) and the developing ring (140) at corresponding positions is greater than the width of the developing ring (140) along the length direction of the bendable tube.
2. The bendable tube according to claim 1 is characterized in that a notch (141) is provided on the developing ring (140), and the spring wire of the spring tube (120) passes through the notch (141).
3. The bendable tube according to claim 1, characterized in that the pitch of the spring tube (120) is unevenly distributed.
4. The bendable tube according to claim 3 is characterized in that the pitch of the middle portion of the spring tube (120) is greater than the pitch of the two end portions.
5. The bendable tube according to claim 1, characterized in that the outer diameters of the bendable tubes (100) are the same, and the inner diameters of the two ends of the bendable tube (100) are larger than the inner diameter of the middle part of the bendable tube (100);

   Alternatively, the inner diameters of the bendable tubes (100) are the same, and the outer diameters of the two end portions of the bendable tube (100) are smaller than the outer diameter of the middle portion of the bendable tube (100).
6. The bendable tube according to claim 1, characterized in that the length of the inner tube (110) is different from the length of the outer tube (130), so that two axial ends of the bendable tube (100) form stepped connecting portions.
7. The bendable tube according to claim 1 is characterized in that it also includes a fiber channel tube (150), wherein the fiber channel tube (150) is arranged between the inner tube (110) and the outer tube (130); the inner cavity of the fiber channel tube (150) is used for the optical fiber (160) to pass through.
8. The bendable tube according to claim 7, characterized in that a notch (141) is provided on the developing ring (140), and the optical fiber channel tube (150) is arranged at a position corresponding to the notch (141).
9. A blood pump, characterized by comprising the bendable tube (100) according to any one of claims 1-8.
10. The blood pump according to claim 9, characterized in that: the blood pump (10) further comprises a pigtail catheter (200), an impeller (500), a motor (600) and a catheter (700);

    The pigtail catheter (200) is connected to the front end of the bendable tube (100), and a blood inlet (310) is provided between the pigtail catheter (200) and the bendable tube (100);

    The catheter (700) is connected to the rear end of the bendable tube (100), and a blood outlet (410) is provided between the bendable tube (100) and the catheter (700);

    The impeller (500) is disposed in the bendable tube (100), the motor (600) comprises a stator side and an output shaft (610), the output shaft (610) is fixedly connected to the impeller (500), and the stator side is fixedly connected to the guide tube (700).
11. A method for manufacturing a bendable tube, characterized in that the method comprises:

    The inner tube (110) is sleeved on the outer surface of the lining rod (20);

    The spring tube (120) and the developing ring (140) are sleeved on the outer surface of the inner tube (110);

    The outer tube (130) is sleeved on the outer surface of the spring tube (120);

    A heat shrink tube (30) is sheathed on the outer side of the outer tube (130), and a heat shrinking treatment process is performed to obtain a bendable tube (100) after the heat shrinking treatment.
12. The method for manufacturing a bendable pipe according to claim 11, characterized in that the outer surface of the lining rod (20) is provided with a polytetrafluoroethylene coating, and the method further comprises:

    Before the inner tube (110) is sleeved on the outer surface of the liner rod (20), silicone oil is applied to the outer surface of the liner rod (20).
13. The method for manufacturing a bendable tube according to claim 11, characterized in that a notch (141) is provided on the developing ring (140); the method further comprises:

    After the spring tube (120) and the developing ring (140) are sleeved on the outer surface of the inner tube (110), the relative positions of the spring wire of the spring tube (120) and the developing ring (140) are adjusted so that the spring wire of the spring tube (120) passes through the notch (141).
14. The method for manufacturing a bendable tube according to claim 11, characterized in that the heat shrinkable tube (30) comprises a polytetrafluoroethylene heat shrinkable tube or a polytetrafluoroethylene heat shrinkable tube;

    The heat shrinking temperature in the heat shrinking treatment process is 150-250°; the heat shrinking time in the heat shrinking treatment process is 5-20 minutes.
15. The method for manufacturing a bendable tube according to claim 11, characterized in that the method further comprises a shaping process; the shaping process comprises: placing the bendable tube (100) after heat shrinkage treatment into a shaping cavity (41) of a shaping mold (40), and placing the shaping mold (40) into a hot air box or a heat treatment furnace for shaping, and cooling and drying to obtain the shaped bendable tube (100);

    Wherein, the setting temperature in the setting treatment process is 100-160° C.; the setting time in the setting treatment process is 20-60 minutes.
16. The method for manufacturing a bendable tube as described in claim 11 is characterized in that the diameter of the two end portions of the lining rod (20) is larger than the diameter of the middle portion of the lining rod (20), so that the inner diameter of the two end portions of the obtained bendable tube (100) is larger than the inner diameter of the middle portion of the bendable tube (100).
17. The method for manufacturing a bendable tube according to claim 11, characterized in that the method further comprises: arranging the optical fiber channel tube (150) between the spring tube (120) and the inner tube (110); or,

    The fiber channel tube (150) is disposed between the spring tube (120) and the outer tube (130).
18. The method for manufacturing a bendable tube according to claim 17, characterized in that the optical fiber channel tube (150) is arranged between the spring tube (120) and the inner tube (110), and before the spring tube (120) and the developing ring (140) are sleeved on the outer surface of the inner tube (110), the method further comprises:

    Adhere the optical fiber channel tube (150) to the outer surface of the inner tube (110);

    A heat shrink tube (30) is sheathed on the outer sides of the inner tube (110) and the optical fiber channel tube (150), and a preliminary heat shrinkage treatment process is performed.