Catheters and blood pumps

Abstract

This application relates to a catheter and a blood pump; the catheter includes a main body segment extending axially and a connecting segment connected to the main body segment, the connecting segment being connectable to a drive device; the main body segment has a first deflection, and the connecting segment has a second deflection, the second deflection being greater than the first deflection; the blood pump includes a cannula, an impeller, a drive device, and a catheter as described in any of the above technical solutions; the cannula is connected to the distal end of the drive device, the connecting segment of the catheter is connected to the proximal end of the drive device, the impeller is disposed within the cannula and is drivenly connected to the drive device; one end of the connecting segment is connected to the main body segment, and the other end of the connecting segment is connected to the drive device; because the second deflection of the connecting segment is greater than the first deflection of the main body segment, the catheter of the connecting segment will not be too flexible due to the presence of the drive device, thus solving the problem of traditional catheters being difficult to bend and damaging blood vessels.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a catheter and a blood pump. Background Technology

[0002] As an important component of the blood pump, the catheter is mainly used to deliver blood to the patient's ventricle through blood vessels, so that the blood pump can deliver blood from the ventricle to the blood vessels.

[0003] However, traditional catheters have the same deflection along their axis, which makes it difficult for the portion of the catheter near the drive device on the blood pump to bend when passing through the bends of small blood vessels, thus preventing damage to the blood vessels. Summary of the Invention

[0004] Therefore, it is necessary to provide a catheter and blood pump to address the problem that the part of the existing catheter near the drive device is not easy to bend.

[0005] On the one hand, this application provides a conduit, which includes a main body segment extending sequentially along the axial direction and a connecting segment connected to the main body segment, the connecting segment being capable of being connected to a driving device;

[0006] The main body segment has a first deflection, and the connecting segment has a second deflection, the second deflection being greater than the first deflection.

[0007] In one embodiment, the main body segment includes a main body and reinforcing wires passing only through the main body; wherein the main body has a third deflection; and the second deflection is less than the third deflection.

[0008] In one embodiment, the main body includes a first inner layer, a first outer layer and a first reinforcing layer disposed between the first inner layer and the first outer layer, which are coaxially arranged.

[0009] The connecting section includes a connecting pipe body connected to the main body. The connecting pipe body includes a second inner layer, a second outer layer and a second reinforcing layer arranged coaxially. The second reinforcing layer is disposed on the inner wall surface of the second inner layer, or between the second inner layer and the second outer layer.

[0010] Wherein, the deflection of the second reinforcing layer is less than that of the first reinforcing layer, so that the second deflection of the connecting segment is less than the third deflection of the main body.

[0011] In one embodiment, at least one of the first reinforcing layer and the second reinforcing layer is a woven mesh or a filler layer; or / and, the first reinforcing layer and the second reinforcing layer are integrally connected.

[0012] In one embodiment, both the first reinforcing layer and the second reinforcing layer are woven meshes made of braided yarns; wherein...

[0013] The braided yarns of the second reinforcing layer have a larger mesh count than those of the braided yarns of the first reinforcing layer, so that the deflection of the second reinforcing layer is less than that of the first reinforcing layer; and / or,

[0014] The deflection of the braided yarns in the second reinforcing layer is less than that in the first reinforcing layer, so that the deflection of the second reinforcing layer is less than that of the first reinforcing layer.

[0015] In one embodiment, the main tube includes a first inner layer and a first outer layer coaxially arranged; the connecting segment includes a connecting tube connected to the main tube, the connecting tube including a second inner layer and a second outer layer coaxially arranged; wherein...

[0016] The wall thickness of one of the first inner layer and the first outer layer is greater than the wall thickness of the second inner layer and / or the second outer layer, and the connecting segment further includes a second reinforcing layer, which is disposed on the inner wall surface of the second inner layer or between the second inner layer and the second outer layer, so that the second deflection of the connecting segment is less than the third deflection of the main body.

[0017] In one embodiment, the connecting segment includes a connecting tube connected to the main body, the wall thickness of the connecting tube being greater than the wall thickness of the main body, such that the second deflection of the connecting segment is less than the third deflection of the main body.

[0018] In one embodiment, the main tube includes a first inner layer and a first outer layer disposed outside the first inner layer; the connecting tube includes a second inner layer and a second outer layer disposed outside the second inner layer, wherein the outer wall surface of the second outer layer is flush with the outer wall surface of the first outer layer along the axial direction.

[0019] Wherein, the wall thickness of one of the second inner layer and the second outer layer is greater than the wall thickness of the first inner layer and / or the wall thickness of the first outer layer.

[0020] In one embodiment, the connecting segment includes a connecting tube connected to the main body, and a reinforcing wire passing through the connecting tube, the reinforcing wire extending axially along the connecting segment, the deflection of the reinforcing wire being greater than the deflection of the reinforcing wire in the main body.

[0021] In one embodiment, one end of the reinforcing wire is connected to the end of the reinforcing wire facing the connecting segment, and the other end of the reinforcing wire is configured to be spaced apart from the driving device or to abut against the driving device.

[0022] Alternatively, the reinforcing filament may be made of the same material as the reinforcing filament, and the diameter of the reinforcing filament may be smaller than the diameter of the reinforcing filament.

[0023] Alternatively, the diameter of the reinforcing filament is the same as the diameter of the reinforcing filament, and the hardness of the material of the reinforcing filament is less than the hardness of the material of the reinforcing filament.

[0024] In one embodiment, the reinforcing wire is bonded to the inner surface of the main tube, or the main tube is provided with a support seat, and the reinforcing wire is fixed in the main tube by the support seat.

[0025] In one embodiment, the connecting segment and the main body segment are made of different materials, such that the second deflection of the connecting segment is greater than the first deflection of the main body segment;

[0026] Alternatively, the connecting segment and the main body segment may be made of the same material with different hardnesses, so that the second deflection of the connecting segment is greater than the first deflection of the main body segment.

[0027] In one embodiment, the axial length of the connecting segment is 20mm to 40mm.

[0028] On the other hand, this application also provides a blood pump, which includes a cannula, an impeller, a drive device, and a catheter as described in any of the above technical solutions. The cannula is connected to the distal end of the drive device, the connecting section of the catheter is connected to the proximal end of the drive device, and the impeller is disposed inside the cannula and is drivenly connected to the drive device.

[0029] The aforementioned catheter and blood pump have a connecting segment with one end connected to the main body and the other end connected to the drive device. Since the second deflection of the connecting segment is greater than the first deflection of the main body, the catheter in the connecting segment will not be too flexible due to the presence of the drive device, thus solving the problem of traditional catheters being difficult to bend and damaging blood vessels. Attached Figure Description

[0030] Figure 1 This is a three-dimensional structural diagram of a blood pump provided in an embodiment of this application.

[0031] Figure 2 This is a cross-sectional view of a catheter provided in an embodiment of this application.

[0032] Figure 3 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0033] Figure 4 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0034] Figure 5 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0035] Figure 6 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0036] Figure 7 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0037] Figure 8 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0038] Figure 9 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0039] Figure 10 for Figure 9 The provided duct is shown in cross-sectional view along the AA direction.

[0040] Figure 11 A cross-sectional view of the main body of another type of catheter provided in this application.

[0041] Figure 12 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0042] Figure 13 for Figure 12 The provided duct is shown in cross-sectional view in the BB direction.

[0043] Figure 14 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0044] Figure 15 for Figure 14 The provided duct is shown in cross-sectional view in the CC direction.

[0045] Figure 16 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0046] Figure 17 This is a cross-sectional view of another catheter provided in an embodiment of this application.

[0047] The labels in the attached diagram are explained as follows:

[0048] 10. Conduit; 110. Connecting tube body; 111. Second outer layer; 112. Second inner layer; 113. Second reinforcing layer; 120. Main tube body; 120a. Positioning groove; 121. First outer layer; 122. First inner layer; 123. First reinforcing layer; 124. Reinforcing wire; 125. Support base; 126. Mounting hole; 20. Sleeve; 20a. Liquid inlet; 20b. Liquid outlet; 30. Drive device. Detailed Implementation

[0049] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0050] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0051] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0052] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0053] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0054] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0055] It should be noted that the terms "distal" and "proximal" in the text are only used to indicate relative positional relationships. The "distal" end of a component refers to the end that enters the patient's body first and / or is farther away from the operator during normal operation, while the "proximal" end refers to the end that enters the patient's body later and / or is closer to the operator.

[0056] A blood pump, also known as a ventricular assist device, pumps blood from the ventricles of the heart to the arteries of the body during surgery or treatment. Figure 1 As shown, the blood pump includes a cannula 20, an impeller, a drive unit 30, and a catheter 10. The proximal end of the cannula 20 is connected to the distal end of the drive unit 30, and the proximal end of the drive unit 30 is connected to the distal end of the catheter 10. The catheter 10 is used to deliver the blood pump to the designated location on the patient. The impeller is located inside the cannula 20 and is connected to the drive unit 30 for transmission. The cannula 20 has an inlet 20a and an outlet 20b. The distal end of the cannula 20 extends into the ventricle, with the inlet 20a located inside the ventricle and the outlet 20b located inside the artery. The drive unit 30 drives the impeller to rotate inside the cannula 20. The impeller pumps blood from the ventricle into the cannula 20 through the inlet 20a. The blood entering the cannula 20 then flows out through the outlet 20b, which is located proximal to the inlet 20a, into the artery, thus realizing the pumping of blood.

[0057] During implementation, the applicant discovered that the catheter 10 needs to have a certain degree of flexibility. When the blood pump is guiding the blood into the patient's ventricle through the blood vessel, if it passes through a bend in the blood vessel, the catheter 10 bends due to its flexibility, which facilitates the introduction of blood. If the catheter 10 is too flexible, it is very easy to get tangled or twisted when passing through the bend in the blood vessel (especially the bend in small blood vessels), making it difficult to advance the catheter 10 further. At the same time, if the catheter 10 has too much deflection, it will be difficult to bend when passing through the bend in the blood vessel (especially the bend in small blood vessels), which may lead to the catheter 10 being unable to bend further or even damaging the blood vessel.

[0058] The applicant further discovered that in traditional blood pumps, the axial deflection of catheter 10 is uniform. However, the distal end of catheter 10 is connected to drive device 30. The presence of drive device 30 causes the deflection of the distal region of catheter 10 to be less than that of other regions of catheter 10. This results in the distal region of catheter 10 having poor bending ability due to its small deflection during the blood pump's entry into the ventricle, especially when passing through the bends of small blood vessels. This can easily damage blood vessels due to the low degree of bending, posing additional risks to patients and causing inconvenience to doctors.

[0059] Therefore, such as Figure 1 As shown, this embodiment provides a conduit 10, which includes a main body segment extending sequentially along the axial direction and a connecting segment connected to the main body segment. The connecting segment can be connected to a driving device 30. The main body segment has a first deflection, and the connecting segment has a second deflection, the second deflection being greater than the first deflection.

[0060] like Figure 1 As shown, the connecting segment is located at the position where the catheter 10 is connected to the drive device 30. Since it is close to the drive device 30, its deflection is set to be greater than that of the main body segment at other positions of the catheter 10, thereby improving the bending performance of the connecting segment. This prevents the connecting segment from being difficult to bend when passing through small curved blood vessels due to insufficient deflection, thus solving the problem of damage to blood vessels caused by difficulty in deformation due to insufficient deflection.

[0061] It should be noted that the deflection in this application refers to the displacement of each point on the axis of the conduit 10 within the plane normal to the axis at that point when it deforms. The greater the deflection, the stronger the deformation capacity of the conduit 10, that is, the easier it is to bend. For example, if the second deflection of the connecting segment is greater than the first deflection of the main segment, it means that, under the same conditions, the bending deformation capacity of the connecting segment is better than that of the main segment, and it is easier to deform. Of course, it can also be understood that the second deflection of the connecting segment is greater than the first deflection of the main segment, that is, the diameter of the bend after the ultimate bending of the connecting segment is smaller than the diameter of the bend after the ultimate bending of the main segment.

[0062] like Figure 2As shown, in one embodiment, the main body section includes a main tube body 120 and a reinforcing wire 124 that is only disposed within the main tube body 120; wherein, the main tube body 120 has a third deflection; the second deflection is less than the third deflection.

[0063] In the conventional catheter 10, the main body section and the connecting section have the same structure and both are provided with a reinforcing wire 124. Therefore, the deflection of the connecting section is smaller and it is difficult to bend. In this embodiment, the deflection of the connecting section is less than the deflection of the main tube body 120 and at the same time greater than the deflection of the main body section, so that the deflection of the connecting section is neither too large nor too small to adapt to the passing requirements of small blood vessels.

[0064] Define the deflection of the connecting section having the same structure as the main tube body 120 as I1, define the deflection of the connecting section having the same structure as the main tube body 120 after further disposing the reinforcing wire 124 as I2, and define the deflection of the connecting section in this embodiment as I3. Then I2 < I3 < I1; that is, the deflection of the connecting section provided in this embodiment is both increased compared with the deflection of the conventional structure and the bending ability is stronger, and at the same time it is decreased compared with the deflection after directly removing the reinforcing wire 124 from the connecting section, and it is not too easy to bend, so as to obtain a connecting section with a moderate deflection.

[0065] Optionally, the reinforcing wire 124 is a metal guide wire to enhance the deflection of the main body section.

[0066] In one embodiment, as Figure 3 shown, the main tube body 120 includes a first inner layer 122, a first outer layer 121 arranged coaxially, and a first reinforcing layer 123 disposed between the first inner layer 122 and the first outer layer 121. As Figure 3 shown, the connecting section includes a connecting tube body 110 connected to the main tube body 120. The connecting tube body 110 includes a second inner layer 112, a second outer layer 111 arranged coaxially, and a second reinforcing layer 113. The second reinforcing layer 113 is disposed between the second inner layer 112 and the second outer layer 111. Among them, the deflection of the second reinforcing layer 113 is less than the deflection of the first reinforcing layer 123, so that the second deflection of the connecting section is less than the third deflection of the main tube body 120.

[0067] As Figure 3 shown, both the main tube body 120 and the connecting tube body 110 include a three-layer structure. Among them, the deflection of the second reinforcing layer 113 of the connecting tube body 110 is less than the deflection of the first reinforcing layer 123, so that the deflection of the connecting section is less than the deflection of the main tube body 120. However, due to the presence of the reinforcing wire 124, the combined deflection of the main tube body 120 and the reinforcing wire 124 makes the deflection of the main body section less than the deflection of the connecting section, thus avoiding the deflection of the connecting section being too small and difficult to bend.

[0068] Of course, in other embodiments, the second reinforcing layer 113 may also be disposed on the inner wall surface of the second inner layer 112. The second reinforcing layer 113 is located on the radially inner side of the connecting segment. Compared with the inner side, the radially outer side of the connecting segment has a relatively higher deflection, so as to better contact the wall surface of the blood vessel and reduce the stimulation of the blood vessel wall.

[0069] The first outer layer 121, the first inner layer 122, the second outer layer 111, and the second inner layer 112 can all be made of medical-grade materials, such as the polymer material 7233Pebax + 20%–30% BaSO4. It should be noted that 7233Pebax + 20%–30% BaSO4 refers to a thermoplastic elastomer polymerized from flexible polyether and rigid polyamide, containing 20%–30% barium sulfate by mass.

[0070] In one embodiment, please refer to Figures 3 to 5 At least one of the first reinforcing layer 123 and the second reinforcing layer 113 is a woven mesh or a filling layer.

[0071] Both woven mesh and filler layers can improve deflection so that the deflection of the connecting pipe 110 is less than that of the main pipe 120.

[0072] Optionally, such as Figure 3 As shown, both the first reinforcing layer 123 and the second reinforcing layer 113 are woven meshes, and the deflection of the second reinforcing layer 113 is less than that of the first reinforcing layer 123. Alternatively, it could be as follows: Figure 5 As shown, the first reinforcing layer 123 is a filler layer, and the second reinforcing layer 113 is a woven mesh. The deflection of the second reinforcing layer 113 is less than that of the first reinforcing layer 123.

[0073] Both of the above settings can make the deflection of the connecting tube 110 less than that of the main tube 120, and the overall deflection of the connecting section greater than that of the main body. On the one hand, this allows the connecting section to bend better to match the curvature of the small-diameter curved blood vessel, and on the other hand, it has a certain degree of deflection to meet the requirement that it will not bend and knot easily.

[0074] In one embodiment, the first reinforcing layer 123 and the second reinforcing layer 113 are integrally connected.

[0075] The first reinforcing layer 123 and the second reinforcing layer 113 are integrally connected to facilitate integral manufacturing. For example, both the first reinforcing layer 123 and the second reinforcing layer 113 are woven meshes, and the first reinforcing layer 123 and the second reinforcing layer 113 are woven together integrally, which reduces the process cost and also enhances the connection reliability between the main body section and the connecting section.

[0076] In one embodiment, such as Figure 3 and Figure 4As shown, both the first reinforcing layer 123 and the second reinforcing layer 113 are woven meshes made of braided yarns; wherein,

[0077] One implementation method is: such as Figure 3 As shown, the mesh count of the braided yarn in the second reinforcing layer 113 is greater than that in the first reinforcing layer 123, so that the deflection of the second reinforcing layer 113 is less than that of the first reinforcing layer 123.

[0078] Alternatively, the braiding wire can be metal wire. The metal wire can be made of materials such as SUS304 stainless steel, the composition of which is shown in Table 1-1 below.

[0079] Table 1-1

[0080]

[0081] Optionally, the second reinforcing layer 113 is woven with a mesh count of 45 to 55 (e.g., 45, 47, 49, 51, 53, 55, etc.), and the first reinforcing layer 123 is woven with a mesh count of 35 to 42 (e.g., 35, 37, 39, 42, etc.). That is, the weaving density of the second reinforcing layer 113 is greater than that of the first reinforcing layer 123, so that the deflection of the second reinforcing layer 113 is less than that of the first reinforcing layer 123.

[0082] Optionally, the number of spindles in the second reinforcing layer 113 is 15 to 17 (e.g., 15, 16, or 17 spindles).

[0083] Another implementation is that the deflection of the braided yarns of the second reinforcing layer 113 is less than the deflection of the braided yarns of the first reinforcing layer 123, so that the deflection of the second reinforcing layer 113 is less than the deflection of the first reinforcing layer 123.

[0084] like Figure 4 As shown, the mesh count of the braided filaments in the second reinforcing layer 113 is the same as that in the first reinforcing layer 123. However, in this case, the diameter of the braided filaments in the second reinforcing layer 113 is larger than that in the first reinforcing layer 123, so that the deflection of the braided filaments in the second reinforcing layer 113 is smaller than that in the first reinforcing layer 123.

[0085] Optionally, the diameter of the braided filaments in the second reinforcing layer 113 is 0.045 mm to 0.055 mm (e.g., 0.045 mm, 0.047 mm, 0.049 mm, 0.051 mm, 0.053 mm, 0.055 mm, etc.), and the diameter of the braided filaments in the first reinforcing layer 123 is 0.030 mm to 0.042 mm (e.g., 0.030 mm, 0.032 mm, 0.034 mm, 0.036 mm, 0.038 mm, 0.040 mm, 0.042 mm, etc.).

[0086] The filling layer can be a medical-grade filling material, such as Pebax (polyether block polyamide).

[0087] In one embodiment, such as Figure 6 As shown, the main body 120 includes a first inner layer 122 and a first outer layer 121 coaxially arranged; the connecting section includes a connecting pipe 110 connected to the main body 120, the connecting pipe 110 including a second inner layer 112 and a second outer layer 111 coaxially arranged; wherein, the wall thickness of one of the first inner layer 122 and the first outer layer 121 is greater than the wall thickness of the second inner layer 112 or / and the second outer layer 111, and the connecting section also includes a second reinforcing layer 113, the second reinforcing layer 113 being disposed on the inner wall surface of the second inner layer 112 or between the second inner layer 112 and the second outer layer 111, so that the second deflection of the connecting section is less than the third deflection of the main body 120.

[0088] In this embodiment, the second reinforcing layer 113 improves the deflection of the connecting section, while the main body 120 improves the deflection of the main body section by increasing the wall thickness. Compared with the method of setting the first reinforcing layer 123 in the main body 120, the process is simpler.

[0089] In one embodiment, such as Figure 8 As shown, the connecting section includes a connecting pipe 110 connected to the main pipe 120. The wall thickness of the connecting pipe 110 is greater than the wall thickness of the main pipe 120, so that the second deflection of the connecting section is less than the third deflection of the main pipe 120.

[0090] Compared to using a reinforcing layer to improve the deflection of the connecting pipe 110 and the main pipe 120, simply adjusting the wall thickness of the connecting pipe 110 and the main pipe 120 results in a simpler manufacturing process and lower cost.

[0091] In one embodiment, such as Figure 8 As shown, the main pipe 120 includes a first inner layer 122 and a first outer layer 121 disposed outside the first inner layer 122; the connecting pipe 110 includes a second inner layer 112 and a second outer layer 111 disposed outside the second inner layer 112, with the outer wall surface of the second outer layer 111 flush with the outer wall surface of the first outer layer 121 along the axial direction. The wall thickness of one of the second inner layer 112 and the second outer layer 111 is greater than the wall thickness of the first inner layer 122 and / or the wall thickness of the first outer layer 121.

[0092] like Figure 8 As shown, both the main pipe 120 and the connecting pipe 110 adopt a double-layer structure, and the overall wall thickness of the connecting pipe 110 is greater than the overall wall thickness of the main pipe 120, so that the deflection of the connecting pipe 110 is less than the deflection of the main pipe 120.

[0093] Specifically, the thickness of the second outer layer 111 is the same as the thickness of the first outer layer 121, but the thickness of the second inner layer 112 is greater than the thickness of the first inner layer 122, thereby making the overall wall thickness of the connecting pipe 110 greater than the overall wall thickness of the main pipe 120.

[0094] like Figure 8 As shown, the outer wall surfaces of the first outer layer 121 and the second outer layer 111 are flush with each other along the axial direction of the catheter 10 to form a smooth outer surface of the catheter 10, preventing thrombus formation on the outer surface of the catheter 10.

[0095] In one embodiment, the connecting segment includes a connecting tube 110 connected to the main tube 120, and a reinforcing wire passing through the connecting tube 110. The reinforcing wire extends axially along the connecting segment, and the deflection of the reinforcing wire is greater than the deflection of the reinforcing wire 124 inside the main tube.

[0096] This embodiment adopts a different method of improving the deflection of the connecting pipe body 110 than the aforementioned method of changing the pipe wall thickness or setting a reinforcing layer: by setting reinforcing wires, the deflection of the connecting pipe body 110 is reduced. At the same time, the deflection of the reinforcing wires is greater than the deflection of the reinforcing wires 124, so that the overall deflection of the connecting section is greater than the overall deflection of the main body section, but less than the deflection of the main pipe body 120.

[0097] In one embodiment, one end of the reinforcing wire is connected to one end of the reinforcing wire 124 facing the connecting section, and the other end of the reinforcing wire is configured to be spaced apart from the driving device 30 or to abut against the driving device 30.

[0098] The proximal end of the reinforcing wire is connected to the reinforcing wire 124, for example, they can be coaxially connected.

[0099] The distal end of the reinforcing wire can be spaced from the proximal end of the drive device 30. On the one hand, the deflection of the reinforcing wire is greater than that of the reinforcing wire 124, so that the deflection of the connecting section is greater than that of the main body section. On the other hand, the length of the reinforcing wire does not abut against the drive device 30, further increasing the deflection of the connecting section, but at the same time being less than the deflection of the main body 120.

[0100] Of course, since the deflection of the reinforcing wire is greater than that of the reinforcing wire 124, even if the far end of the reinforcing wire abuts against the near end of the drive device 30, that is, the reinforcing wire runs through the entire connecting section, the deflection of the connecting section is greater than that of the main body section, but less than that of the main body 120.

[0101] Of course, in other embodiments, the deflection of the reinforcing filament can be greater than that of the reinforcing filament 124 by using different materials. For example:

[0102] One approach is to use a reinforcing wire made of the same material as the reinforcing wire 124, with the diameter of the reinforcing wire being smaller than that of the reinforcing wire 124.

[0103] Although the materials are the same, the diameter of the reinforcing wire is smaller than that of the reinforcing wire 124, so the deflection of the reinforcing wire is greater than that of the reinforcing wire 124.

[0104] Another approach is to use a reinforcing wire with the same diameter as the reinforcing wire 124, and to use a material with a lower hardness than the material with a reinforcing wire 124.

[0105] Although the reinforcing wire and the reinforcing wire 124 have the same diameter, the material hardness of the reinforcing wire is less than that of the reinforcing wire 124, which makes the deflection of the reinforcing wire greater than that of the reinforcing wire 124.

[0106] In one embodiment, such as Figures 9 to 13 As shown, the reinforcing wire 124 is bonded to the inner surface of the main body 120.

[0107] The reinforcing wire 124 is fixed to the main body 120 by bonding, so that the position of the reinforcing wire 124 does not change, improving the structural stability of the conduit 10. At the same time, the bonding method is easy to operate.

[0108] like Figure 9 and Figure 10 In the embodiment shown, the reinforcing wire 124 is directly bonded to the inner wall of the main tube 120.

[0109] For example Figures 11 to 13 In the illustrated embodiment, the inner wall of the main tube 120 is provided with a positioning groove 120a, which is opened along the axial direction of the main tube 120, and the groove wall of the positioning groove 120a matches the outer wall of the reinforcing wire 124. This arrangement allows the reinforcing wire 124 to extend along the groove wall of the positioning groove 120a and be positioned and bonded, thus achieving better installation and positioning and preventing the reinforcing wire 124 from becoming entangled with other wiring, such as control wiring.

[0110] In one embodiment, such as Figures 14 to 17 The main body 120 is provided with a support seat 125, and the reinforcing wire 124 is fixed in the main body 120 through the support seat 125.

[0111] Compared to adhesive bonding, the support base 125 can better fix the position of the reinforcing wire 124 and prevent the reinforcing wire 124 from moving within the main body 120; at the same time, the support base 125 can also be used as a wiring bracket for other lines such as control lines or flushing pipes.

[0112] like Figures 14 to 17 As shown, the support base 125 is roughly a circular plate structure, and the peripheral wall of the support base 125 is connected to the inner wall of the main body 120 by means of bonding or interference fit.

[0113] like Figure 14 and Figure 15 As shown, the distal end of the reinforcing wire 124 is bonded and fixed to or abuts against the support base 125.

[0114] like Figure 16 and Figure 17 As shown and combined Figure 15 The support base 125 is provided with at least two mounting holes 126 along the axial direction. One mounting hole 126 is used to support the reinforcing wire 124, and the other mounting holes 126 (through-hole) are used to allow the control line and / or flushing pipeline to pass through and provide support. They also serve to separate the reinforcing wire 124, the control line and the flushing pipeline to prevent them from getting tangled together.

[0115] like Figure 16 As shown, the mounting hole 126 for mounting the reinforcing wire 124 is a blind hole opened along the axial direction of the support 125, and the distal end of the reinforcing wire 124 extends into the blind hole. The reinforcing wire 124 can be fixed to the support 125 by adhesive bonding or by interference fit with the support 125 through the blind hole.

[0116] like Figure 17 As shown, the mounting hole 126 for mounting the reinforcing wire 124 is a through hole that extends through the support base 125 along the axial direction. The distal end of the reinforcing wire 124 extends into the through hole and is bonded and fixed to the support base 125 to achieve better support and connection.

[0117] In one embodiment, the connecting segment and the main body segment are made of different materials, such that the second deflection of the connecting segment is greater than the first deflection of the main body segment.

[0118] In this embodiment, the different deflections of the connecting section and the main body section are achieved simply by using different materials. Compared with setting a reinforcing layer, reinforcing wire 124 or different pipe wall thicknesses, the method of achieving this solely through materials is simpler.

[0119] The connecting segment and the main body segment can be made of different materials, all of which are medical grade, such as Pebax (polyether block polyamide), TPU (thermoplastic polyurethane elastomer), PE (polyethylene), HDPE (high-density polyethylene), LDPE (low-density polyethylene), etc. For example, the connecting segment can be LDPE (low-density polyethylene), while the main body segment can be HDPE (high-density polyethylene).

[0120] Of course, in other embodiments, the same material can be used, but different hardnesses are required. That is, the connecting segment and the main body segment are made of the same material with different hardnesses, so that the second deflection of the connecting segment is greater than the first deflection of the main body segment.

[0121] For example, both the connecting segment and the main body segment may use Pebax (polyether block polyamide), but the hardness of the Pebax used in the connecting segment may be different from that of the Pebax used in the main body segment, so that the second deflection of the connecting segment is greater than the first deflection of the main body segment.

[0122] like Figure 7 As shown, the main body segment includes a main pipe 120 and reinforcing wires 124, and the connecting segment includes a connecting pipe 110. The wall thickness of the connecting pipe 110 is the same as that of the main pipe 120, and both are made of the same Pebax. The Pebax used in the connecting pipe 110 can have a hardness of 55D, while the Pebax used in the main pipe 120 can have a hardness of 45D, so that the deflection of the connecting pipe 110 is less than that of the main pipe 120. Due to the presence of the reinforcing wires 124, the overall deflection of the main body segment is less than that of the connecting segment. It should be noted that D here refers to Shore hardness.

[0123] In one embodiment, the axial length of the connecting segment is 20mm to 40mm.

[0124] The axial length of the connecting segment can be 20mm, 25mm, 30mm, 35mm, 40mm, etc., so that the connecting segment of the catheter 10 can be adapted to the curvature of the small blood vessels in the patient's body after bending, thereby facilitating the advancement of the blood pump towards the ventricle.

[0125] In one embodiment, the catheter 10 is provided with an indicator on its exterior, which has a scale to facilitate the introduction of blood by medical personnel based on the scale. The indicator can be a coating or a sheet-like or annular protrusion on the outer wall of the catheter 10, and the material used for the indicator is a medical-grade material with corrosion resistance.

[0126] For example, the indicator may be an indicator scale obtained by laser etching on the outer surface of the conduit 10.

[0127] For example, the indicator section can be obtained by spraying medical-grade ink material onto the outer wall of the catheter 10. The medical-grade ink material can be PU (polyurethane) or TPU (thermoplastic polyurethane elastomer), etc.

[0128] like Figure 1 As shown, this application also provides a blood pump, which includes a cannula 20, an impeller, a drive device 30, and a catheter 10 as described in any of the above embodiments. The cannula 20 is connected to the distal end of the drive device 30, the connecting section of the catheter 10 is connected to the proximal end of the drive device 30, and the impeller is disposed inside the cannula 20 and is connected to the drive device 30 for transmission.

[0129] In this blood pump, the catheter 10 has one end connected to the main body and the other end connected to the drive device 30. Since the second deflection of the connecting section is greater than the first deflection of the main body, the catheter 10 of the connecting section will not be too flexible due to the presence of the drive device 30, thus solving the problem that traditional catheters 10 are not flexible and damage blood vessels.

[0130] like Figure 1 As shown, the proximal end of the cannula 20 is connected to the distal end of the drive device 30, and the proximal end of the drive device 30 is connected to the distal end of the catheter 10. The catheter 10 is used to deliver blood to the designated location on the patient. The impeller is located inside the cannula 20 and is connected to the drive device 30 for transmission. The cannula 20 has an inlet 20a and an outlet 20b. The distal end of the cannula 20 extends into the ventricle, with the inlet 20a located inside the ventricle and the outlet 20b located inside the artery. The drive device 30 drives the impeller to rotate inside the cannula 20. The impeller pumps blood from the ventricle into the cannula 20 through the inlet 20a. The blood entering the cannula 20 then flows out through the outlet 20b, which is located proximal to the inlet 20a, into the artery, thus realizing the pumping of blood.

[0131] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0132] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A catheter, characterized in that, The conduit includes a main body segment extending sequentially along the axial direction and a connecting segment connected to the main body segment. The connecting segment is located at the position where the conduit is connected to the driving device and can be connected to the driving device. The main body segment has a first deflection, and the connecting segment has a second deflection, wherein the second deflection is greater than the first deflection; The main body segment includes a main tube and reinforcing wires that pass through the main tube only; wherein the main tube has a third deflection; the second deflection is less than the third deflection.

2. The catheter according to claim 1, characterized in that, The reinforcing wire is a metal guide wire.

3. The catheter according to claim 1, characterized in that, The main body includes a first inner layer, a first outer layer and a first reinforcing layer disposed between the first inner layer and the first outer layer, which are coaxially arranged. The connecting section includes a connecting pipe body connected to the main body. The connecting pipe body includes a second inner layer, a second outer layer and a second reinforcing layer arranged coaxially. The second reinforcing layer is disposed on the inner wall surface of the second inner layer, or between the second inner layer and the second outer layer. Wherein, the deflection of the second reinforcing layer is less than that of the first reinforcing layer, so that the second deflection of the connecting segment is less than the third deflection of the main body.

4. The catheter according to claim 3, characterized in that, At least one of the first reinforcing layer and the second reinforcing layer is a woven mesh or a filler layer; or / and the first reinforcing layer and the second reinforcing layer are integrally connected.

5. The catheter according to claim 3, characterized in that, Both the first reinforcing layer and the second reinforcing layer are woven meshes made of braided yarns; wherein, The braided yarns of the second reinforcing layer have a larger mesh count than those of the braided yarns of the first reinforcing layer, so that the deflection of the second reinforcing layer is less than that of the first reinforcing layer; and / or, The deflection of the braided yarns in the second reinforcing layer is less than that in the first reinforcing layer, so that the deflection of the second reinforcing layer is less than that of the first reinforcing layer.

6. The catheter according to claim 2, characterized in that, The main body includes a first inner layer and a first outer layer coaxially arranged; the connecting section includes a connecting pipe body connected to the main body, the connecting pipe body including a second inner layer and a second outer layer coaxially arranged; wherein... The wall thickness of one of the first inner layer and the first outer layer is greater than the wall thickness of the second inner layer and / or the second outer layer, and the connecting segment further includes a second reinforcing layer, which is disposed on the inner wall surface of the second inner layer or between the second inner layer and the second outer layer, so that the second deflection of the connecting segment is less than the third deflection of the main body.

7. The catheter according to claim 2, characterized in that, The connecting segment includes a connecting pipe body connected to the main body, wherein the wall thickness of the connecting pipe body is greater than the wall thickness of the main body, so that the second deflection of the connecting segment is less than the third deflection of the main body.

8. The catheter according to claim 7, characterized in that, The main tube includes a first inner layer and a first outer layer disposed outside the first inner layer; the connecting tube includes a second inner layer and a second outer layer disposed outside the second inner layer, wherein the outer wall surface of the second outer layer is flush with the outer wall surface of the first outer layer along the axial direction. Wherein, the wall thickness of one of the second inner layer and the second outer layer is greater than the wall thickness of the first inner layer and / or the wall thickness of the first outer layer.

9. The catheter according to claim 2, characterized in that, The connecting section includes a connecting tube body connected to the main body, and a reinforcing wire passing through the connecting tube body. The reinforcing wire extends axially along the connecting section, and the deflection of the reinforcing wire is greater than the deflection of the reinforcing wire in the main body.

10. The catheter according to claim 9, characterized in that, One end of the reinforcing wire is connected to the end of the reinforcing wire facing the connecting section, and the other end of the reinforcing wire is configured to be spaced apart from the driving device or to abut against the driving device. Alternatively, the reinforcing filament may be made of the same material as the reinforcing filament, and the diameter of the reinforcing filament may be smaller than the diameter of the reinforcing filament. Alternatively, the diameter of the reinforcing filament is the same as the diameter of the reinforcing filament, and the hardness of the material of the reinforcing filament is less than the hardness of the material of the reinforcing filament.

11. The catheter according to claim 2, characterized in that, The reinforcing wire is bonded to the inner surface of the main tube, or the main tube is provided with a support seat, and the reinforcing wire is fixed in the main tube by the support seat.

12. The catheter according to claim 1, characterized in that, The connecting segment and the main body segment are made of different materials, so that the second deflection of the connecting segment is greater than the first deflection of the main body segment; Alternatively, the connecting segment and the main body segment may be made of the same material with different hardnesses, so that the second deflection of the connecting segment is greater than the first deflection of the main body segment.

13. The catheter according to claim 1, characterized in that, The length of the connecting section in the axial direction is 20mm~40mm.

14. A blood pump, characterized in that, The blood pump includes a cannula, an impeller, a drive unit, and a catheter as described in any one of claims 1 to 13, wherein the cannula is connected to the distal end of the drive unit, the connecting section of the catheter is connected to the proximal end of the drive unit, and the impeller is disposed within the cannula and is drivenly connected to the drive unit.

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