Housing assembly, manufacturing method thereof, and blood pump

Abstract

The present invention relates to a housing assembly, a manufacturing method thereof, and a blood pump. The housing assembly comprises: a base housing and a catheter. The base housing comprises a base, an inner convex ring, and an outer convex ring, both of which are protruding from the base, with the outer convex ring disposed around the inner convex ring. The catheter comprises an inner sleeve and an outer sleeve, with the outer sleeve disposed around the inner sleeve. The inner sleeve, with one end near the base welded to the inner convex ring, and the outer sleeve, with one end near the base welded to the outer convex ring, is welded to the end of the inner sleeve welded to the inner convex ring, away from the base. This improves the flatness of the base and prevents compression of the inner cavity of the base housing. When the impeller of the blood pump is housed in this cavity, friction between the impeller and the base housing is prevented, thereby improving the safety of the housing assembly and the blood pump.

Description

Technical Field

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

[0002] As an artificial ventricular assist device, the blood pump is currently the main instrument for treating cardiovascular diseases such as cardiogenic shock and heart failure. The blood pump controls the power supply to the coil through the motor, so that the motor generates a rotating electromagnetic field so that the electromagnetic field drives the impeller to rotate, causing blood to flow into the blood pump's liquid inlet and out of the liquid outlet after passing through the impeller, thereby realizing the circulation of blood.

[0003] Currently, the housing assembly of a blood pump is mainly formed by welding. However, the traditional welding method has the risk of friction between the impeller and the housing assembly, leading to serious events such as hemolysis, which ultimately affects the safety of the blood pump. Summary of the Invention

[0004] One technical problem solved by the present invention is how to improve the safety of the housing assembly and the blood pump. The present invention solves the above technical problem through the following technical solutions.

[0005] In a first aspect, the present invention provides a housing assembly comprising:

[0006] A base shell, comprising a base, an inner convex ring and an outer convex ring, wherein the inner convex ring and the outer convex ring are both convexly arranged on the base, and the outer convex ring is arranged around the inner convex ring; and

[0007] The catheter includes an inner sleeve and an outer sleeve, the outer sleeve is arranged around the inner sleeve, the end of the inner sleeve close to the base is welded to the inner convex ring, the end of the outer sleeve close to the base is welded to the outer convex ring, the end of the inner sleeve welded to the inner convex ring away from the base and the end of the outer sleeve welded to the outer convex ring away from the base are welded.

[0008] In one embodiment, the inner convex ring includes a first inner ring and a second inner ring arranged coaxially, the first inner ring is closer to the base than the second inner ring, the thickness of the first inner ring is greater than the thickness of the second inner ring, so as to form a step surface at the end of the first inner ring, the second inner ring is connected to the first inner ring and is arranged around the step surface, the inner sleeve is in contact with the step surface, and the second inner ring is sleeved on the inner sleeve.

[0009] In one embodiment, the inner sleeve includes a first inner tube and a second inner tube arranged coaxially, the first inner tube is farther away from the base body than the second inner tube and is connected to the outer sleeve, the end of the first inner tube has an inner limit surface, the second inner tube is connected to the end of the first inner tube, the inner limit surface is arranged around the second inner tube, the end of the second inner tube abuts the step surface, the second inner ring is sleeved outside the second inner tube, and the end of the second inner ring maintains a set distance or abuts against the inner limit surface.

[0010] In one embodiment, the outer sleeve includes a first outer tube and a second outer tube arranged coaxially, the first outer tube is farther away from the base than the second outer tube, the end of the first outer tube has an outer limit surface, the second outer tube is connected to the end of the first outer tube, the outer limit surface is arranged around the second outer tube, the outer convex ring is arranged outside the second outer tube, and the end of the outer convex ring is abutted against the outer limit surface.

[0011] In one embodiment, a first annular groove is formed on the outer surface of the inner sleeve, and the first annular groove is arranged around the central axis of the inner sleeve; and / or a second annular groove is formed on the inner side surface of the outer sleeve, and the second annular groove is arranged around the central axis of the outer sleeve.

[0012] In a second aspect, the present invention further provides a blood pump comprising any one of the above-mentioned housing assemblies.

[0013] In a third aspect, the present invention further provides a method for manufacturing a housing assembly, comprising the steps of:

[0014] A base shell is provided, the base shell comprising a base body, an inner convex ring and an outer convex ring, the inner convex ring and the outer convex ring are both convexly arranged on the base body, and the outer convex ring is arranged around the inner convex ring;

[0015] Providing a catheter, the catheter comprising an inner cannula and an outer cannula, the outer cannula being disposed around the inner cannula;

[0016] Welding one end of the inner sleeve close to the base shell to the inner convex ring;

[0017] Welding one end of the outer sleeve close to the base shell to the outer convex ring; and

[0018] The end of the inner sleeve welded to the inner convex ring away from the base body and the end of the outer sleeve welded to the outer convex ring away from the base body are welded.

[0019] In one embodiment, before welding the end of the inner sleeve close to the base shell to the inner convex ring, the manufacturing method further includes:

[0020] Providing a mixture of cleaning liquid and pure water, wherein the volume ratio of the cleaning liquid to the pure water is 18:1 to 22:1, and performing a rough cleaning of the base shell and the conduit for 8 minutes to 12 minutes using the mixture;

[0021] Perform multiple passes of fine cleaning on the base shell and the conduit, with each pass of fine cleaning lasting 8 to 12 minutes;

[0022] The base shell and the conduit are dried, wherein the drying temperature is 70° C. to 75° C. and the drying time is 10 min to 12 min.

[0023] In one embodiment, the welding method is laser spot welding, wherein the laser parameters are as follows: peak power of 1.2kw~1.4kw, frequency of 6HZ~9HZ, single pulse laser energy of 1.56J~7.15J, and pulse width of 1.2ms~2ms.

[0024] In one embodiment, after welding the end of the inner sleeve away from the base and the end of the outer sleeve away from the base, the manufacturing method further includes: grinding the end of the inner sleeve away from the base and the end of the outer sleeve away from the base.

[0025] Compared to the prior art, the housing assembly provided by the present invention effectively prevents over-positioning of the catheter in its own axial direction by welding the inner sleeve to the outer sleeve after the outer sleeve and outer convex ring, as well as the inner sleeve and inner convex ring, have already been welded. This eliminates the axial welding stress imposed by the catheter on the base shell, thereby eliminating the axial welding stress on the base. After the inner sleeve and outer sleeve are welded, the welding stress extends radially along the catheter, thereby reducing or eliminating the effect of the welding stress on the flatness of the base, improving the flatness of the base, and preventing compression of the inner cavity of the base shell. When the blood pump impeller is housed in this inner cavity, friction between the impeller and the base shell can be prevented, thereby improving the safety of the housing assembly and the entire blood pump. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a planar cross-sectional view of a conventional housing assembly.

[0027] Figure 2 for Figure 1 Image showing the flatness of the housing assembly after welding is completed.

[0028] Figure 3 for Figure 1 3D image of the flatness of the housing assembly after welding is completed.

[0029] Figure 4A three-dimensional view of a housing assembly provided in an embodiment of the present invention.

[0030] Figure 5 for Figure 4 A plan cross-sectional view of the housing assembly is shown.

[0031] Figure 6 for Figure 4 A planar cross-sectional view of the base shell in the housing assembly is shown.

[0032] Figure 7 for Figure 4 A plan cross-sectional view of a conduit within the housing assembly is shown.

[0033] Figure 8 for Figure 4 Exploded view of housing assembly shown.

[0034] Figure 9 for Figure 4 Another exploded view of the housing assembly is shown.

[0035] Figure 10 A flowchart of the process flow of a method for manufacturing a housing assembly according to an embodiment of the present invention.

[0036] Figure 11 for Figure 4 Image showing the flatness of the housing assembly after welding is completed.

[0037] Figure 12 for Figure 4 3D image of the flatness of the housing assembly after welding is completed. DETAILED DESCRIPTION

[0038] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. The accompanying drawings illustrate preferred embodiments of the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0039] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly attached to the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0040] The inventors of this application have discovered that Figure 1A conventional housing assembly includes a base shell 20 and a conduit 30. The base shell 20 includes a base 23, an inner convex ring 21, and an outer convex ring 22. Both the inner convex ring 21 and the outer convex ring 22 are protrudingly disposed on a base surface 24 of the base 23. The conduit 30 is integrally formed and may include an inner sleeve 31 and an outer sleeve 32. During assembly, the inner sleeve 31 is typically welded to the inner convex ring 21, and the outer sleeve 32 is welded to the outer convex ring 22. Since the conduit 30 is integrally formed, the conduit 30 is positioned twice along its own axial direction during the welding process with the base shell 20. Therefore, the conduit 30 is over-positioned, also called repeated positioning. This will cause the conduit 30 to apply welding stress along the axial direction of the conduit 30 to the base shell 20, that is, the welding stress is distributed along the axial direction of the conduit 30. The welding stress will also be transmitted to the base surface 24 through the inner convex ring 21 and the outer convex ring 22, so that the direction of the welding stress acting on some local parts of the base surface 24 is from the base shell 20 to the conduit 30 along the axial direction of the conduit 30, that is, the direction of the welding stress is from bottom to top; it also causes the direction of the welding stress acting on other local parts of the base surface 24 to be from the conduit 30 to the base shell 20 along the axial direction of the conduit 30, that is, the direction of the welding stress is from top to bottom. Therefore, the welding stress will pull the base surface 24, thereby causing the base surface 24 to produce concave-convex deformation under the axial force, which ultimately affects the flatness of the base surface 24. After measurement and analysis, refer to Figure 2 、 Figure 3 Table 1 shows the measured flatness values ​​of base surface 24. This table indicates that the flatness of base surface 24 is 0.052 mm, failing to meet the design requirement of a flatness of no greater than 0.045 mm. This compresses the inner cavity of base housing 20, reducing the installation space for the impeller. This can cause friction between the impeller and base housing 20, leading to serious events such as hemolysis, ultimately compromising the safety of the blood pump.

[0041] Table 1

[0042]

[0043] In order to improve at least some of the above-mentioned problems, the present application provides a blood pump housing assembly. By forming the catheter separately, two inner sleeves and an outer sleeve that have been independently formed before assembly are welded together to form the catheter. This provides a basis for avoiding over-positioning of the catheter in its own axial direction, thereby eliminating the welding stress applied by the catheter to the base shell along the catheter axis, and thus ensuring that there is no welding stress along the catheter axis on the base surface. After the inner sleeve and the outer sleeve are welded, the welding stress will extend radially along the catheter, thereby reducing or eliminating the effect of the welding stress on the flatness of the base surface, improving the flatness of the base surface, and avoiding compression of the space in the inner cavity of the base shell. When the impeller of the blood pump is housed in this inner cavity, friction between the impeller and the base shell can be prevented, thereby improving the safety of the housing assembly and the entire blood pump. The housing assembly provided by the present application is described in detail below in conjunction with the specific embodiments and the drawings in the specification.

[0044] See Figure 4 、 Figure 5 and Figure 6 A blood pump (not shown) provided in one embodiment of the present invention includes a housing assembly 10. The housing assembly 10 includes a base shell 100 and a catheter 200. The base shell 100 and the catheter 200 are welded together.

[0045] In some embodiments, the base shell 100 includes an inner convex ring 110, an outer convex ring 120, and a base 130. The base 130 has a base surface 131. The inner convex ring 110 is connected to the base surface 131. The inner convex ring 110 protrudes a certain length in the axial direction relative to the base surface 131, so that the inner convex ring 110 is disposed protrudingly relative to the base surface 131. The central axis of the inner convex ring 110 can be perpendicular to the base surface 131. The outer convex ring 120 is connected to the base surface 131. The outer convex ring 120 protrudes a certain length in the axial direction relative to the base surface 131, so that the outer convex ring 120 is disposed protrudingly relative to the base surface 131. The central axis of the outer convex ring 120 can be perpendicular to the base surface 131. The outer convex ring 120 is disposed around the inner convex ring 110. The inner convex ring 110 and the outer convex ring 120 can be coaxial cylindrical rings.

[0046] The inner convex ring 110 includes a first inner ring 111 and a second inner ring 112. The first inner ring 111 and the second inner ring 112 are coaxially arranged. The outer diameters of the first inner ring 111 and the second inner ring 112 can be equal, so that the distances between the outer sides of the first inner ring 111 and the second inner ring 112 and the central axis of the inner convex ring 110 are equal, and the outer sides of the first inner ring 111 and the second inner ring 112 are aligned radially in the inner convex ring 110. The inner diameter of the first inner ring 111 is greater than the inner diameter of the second inner ring 112, so that the distances between the inner sides of the first inner ring 111 and the second inner ring 112 and the central axis of the inner convex ring 110 are unequal, and the outer sides of the first inner ring 111 and the second inner ring 112 are spaced apart radially in the inner convex ring 110. The thickness of the first inner ring 111 is greater than the thickness of the second inner ring 112, so that a step surface 111 is formed at the end of the first inner ring 111. The first inner ring 111 has an end surface located away from the base surface 131. Obviously, this end surface is located at the end of the first inner ring 111. The second inner ring 112 is connected to the end surface. A portion of the end surface away from the central axis of the inner convex ring 110 is covered by the second inner ring 112, while a portion of the end surface close to the central axis of the inner convex ring 110 is not covered by the second inner ring 112. The portion of the end surface not covered by the second inner ring 112 forms a step surface 1111. The step surface 1111 is an annular surface, and the second inner ring 112 is arranged around the step surface 1111. The step surface 1111 can be arranged parallel to the base surface 131, so that the step surface 1111 and the base surface 131 are spaced apart along the axial direction of the inner convex ring 110.

[0047] See Figure 5 、 Figure 7 and Figure 8 In some embodiments, the catheter 200 includes an inner sleeve 210 and an outer sleeve 220. The inner sleeve 210 and the outer sleeve 220 are connected to form the catheter 200 by a separate connection. Therefore, before the catheter 200 is formed, the inner sleeve 210 and the outer sleeve 220 are both formed as independent entities. The outer sleeve 220 is arranged around the inner sleeve 210. The inner sleeve 210 and the outer sleeve 220 can be coaxially arranged. The cross-sections of the inner sleeve 210 and the outer sleeve 220 can be circular. The end of the inner sleeve 210 near the base surface 131 is welded to the inner convex ring 110, and the end of the outer sleeve 220 near the base surface 131 is welded to the outer convex ring 120. The other ends of the inner sleeve 210 and the outer sleeve 220 away from the base surface 131 are welded to each other. The inner sleeve 210 is coaxial with the inner convex ring 110, and the outer sleeve 220 is coaxial with the outer convex ring 120.

[0048] See Figure 7 、 Figure 8 and Figure 9The inner sleeve 210 includes a first inner tube 211 and a second inner tube 212. The first inner tube 211 and the second inner tube 212 are coaxially arranged. The first inner tube 211 is farther away from the base surface 131 than the second inner tube 212. The first inner tube 211 and the outer sleeve 220 are welded to each other at their ends away from the base surface 131. The thickness of the first inner tube 211 is greater than that of the second inner tube 212. The first inner tube 211 has an end surface located near the base surface 131. Obviously, this end surface is located at the end of the first inner tube 211. The second inner tube 212 is connected to the end surface. A portion of the end surface away from the central axis of the inner sleeve 210 is covered by the second inner tube 212, while a portion of the end surface near the central axis of the inner sleeve 210 is not covered by the second inner tube 212. Therefore, the portion of the end surface not covered by the second inner tube 212 forms an inner limiting surface 2111. The inner limiting surface 2111 is an annular surface and is disposed around the second inner tube 212. The inner limiting surface 2111 can be disposed parallel to the base surface 131, such that the step surface 1111 and the base surface 131 are spaced apart along the axial direction of the inner convex ring 110. Along the axial direction of the inner conduit 200, the step surface 1111 is arranged between the base surface 131 and the inner limiting surface 2111. Therefore, the inner limiting surface 2111 is farther away from the base surface 131 than the step surface 1111.

[0049] See Figure 5 、 Figure 6 and Figure 7 To assemble the inner convex ring 110 with the inner sleeve 210, the second inner ring 112 is sleeved onto the outer surface of the second inner sleeve 212, allowing the second inner ring 112 to radially position the second inner sleeve 212 and the entire inner sleeve 210. The end of the second inner sleeve 212 abuts the step surface 1111, allowing the step surface 1111 of the first inner ring 111 to axially position the second inner sleeve 212 and the entire inner sleeve 210. This improves the assembly accuracy and efficiency between the inner convex ring 110 and the inner sleeve 210. The end of the second inner ring 112 can maintain a certain distance from the inner limiting surface 2111, and the end of the second inner ring 112 can also abut against the inner limiting surface 2111. The provision of the inner limiting surface 2111 allows the outer surfaces of the first inner sleeve 211 and the second inner ring 112 to be flush with each other, and the provision of the step surface 1111 allows the inner surfaces of the second inner sleeve 212 and the first inner ring 111 to be flush with each other. After the inner convex ring 110 and the inner sleeve 210 are assembled, welding is performed at the contact point between the inner convex ring 110 and the inner sleeve 210 , thereby achieving a welded connection between the inner convex ring 110 and the inner sleeve 210 .

[0050] See Figure 7 、 Figure 8 and Figure 9The outer sleeve 220 includes a first outer tube 221 and a second outer tube 222. The first outer tube 221 and the second outer tube 222 are coaxially arranged. The first outer tube 221 is farther from the base surface 131 than the second outer tube 222. The first outer tube 221 and the first inner tube 211 are welded to each other at their ends away from the base surface 131. The first outer tube 221 is thicker than the second outer tube 222. The first outer tube 221 has an end surface located near the base surface 131. This end surface is located at the end of the first outer tube 221. The second outer tube 222 is connected to this end surface. A portion of this end surface away from the central axis of the outer sleeve 220 is covered by the second outer tube 222, while a portion of this end surface near the central axis of the outer sleeve 220 is not covered by the second outer tube 222. Therefore, the portion of this end surface not covered by the second outer tube 222 forms an outer limiting surface 2211. This outer limiting surface 2211 is an annular surface and surrounds the second outer tube 222. The outer limiting surface 2211 may be arranged parallel to the base surface 131 , so that the outer limiting surface 2211 and the base surface 131 are spaced apart from each other along the axial direction of the outer protruding ring 120 .

[0051] See Figure 5 、 Figure 6 and Figure 7 To assemble the outer convex ring 120 with the outer sleeve 220, the outer convex ring 120 is placed outside the second outer tube 222, so that the outer convex ring 120 radially positions the second outer tube 222 and the entire outer sleeve 220. The end of the outer convex ring 120 abuts the outer limiting surface 2211, so that the outer convex ring 120 axially positions the first outer tube 221 and the entire outer sleeve 220. This improves the assembly accuracy and efficiency between the outer convex ring 120 and the outer sleeve 220. The provision of the outer limiting surface 2211 allows the outer side surfaces of the first outer tube 221 and the outer convex ring 120 to be flush with each other. After the outer convex ring 120 and the outer sleeve 220 are assembled, the outer convex ring 120 and the outer sleeve 220 are welded at the contact point, thereby achieving a welded connection between the outer convex ring 120 and the outer sleeve 220.

[0052] See Figure 5 and Figure 8In some embodiments, a first annular groove 231 is recessed and formed on the outer surface of the inner sleeve 210. This first annular groove 231 is not covered by the inner convex ring 110. The first annular groove 231 extends along the circumference of the inner sleeve 210, so that the first annular groove 231 occupies a 360° angle along the circumference of the inner sleeve 210, thereby forming a closed loop. The base surface 131 is closer to the first annular groove 231 than the end of the inner sleeve 210 away from the base surface 131. In other words, along the axial direction of the catheter 200, the distance from the end of the inner sleeve 210 away from the base surface 131 to the first annular groove 231 is greater than the distance from the base surface 131 to the first annular groove 231, thereby maintaining a reasonably small distance between the first annular groove 231 and the base surface 131.

[0053] A second annular groove 232 is also recessed and formed on the inner side of the outer sleeve 220. This second annular groove 232 extends circumferentially around the outer sleeve 220, thereby forming a closed loop. The base surface 131 is closer to the second annular groove 232 than the end of the outer sleeve 220 distal to the base surface 131. In other words, along the axial direction of the catheter 200, the distance from the end of the outer sleeve 220 distal to the base surface 131 to the second annular groove 232 is greater than the distance from the base surface 131 to the second annular groove 232, thereby maintaining a reasonably small spacing between the second annular groove 232 and the base surface 131.

[0054] See Figure 4 The blood pump further includes an impeller (not shown), which can be at least partially housed within the inner cavity defined by the base 130. The end of the lumen of the inner cannula 210, located away from the base surface 131, is a liquid inlet 241, and the base 130 is provided with a liquid outlet 242. When the impeller rotates, it generates centrifugal force, causing blood to flow from the liquid inlet 241 into the lumen of the inner cannula 210 and the inner cavity of the base 130, and finally out through the liquid outlet 242.

[0055] See Figure 10 The present invention also provides a manufacturing method for processing and manufacturing the housing assembly 10. The manufacturing method mainly includes the following steps:

[0056] S310 , providing a base shell 100 , the base shell 100 includes an inner convex ring 110 , an outer convex ring 120 and a base body 130 , the inner convex ring 110 and the outer convex ring are both convexly disposed on a base surface 131 of the base body 130 , and the outer convex ring 120 is disposed around the inner convex ring 110 .

[0057] S320 , providing a catheter 200 , wherein the catheter 200 includes an inner sleeve 210 and an outer sleeve 220 , wherein the outer sleeve 210 is disposed around the inner sleeve 220 .

[0058] S330: The end of the inner sleeve 210 closest to the base shell 100 is welded to the inner convex ring 110. Specifically, the base shell 100 and inner sleeve 210 can be first secured with a fixture, and then the end of the inner sleeve 210 closest to the base surface 131 is welded to the inner convex ring 110. After the base shell 100 and inner sleeve 210 are secured by the fixture, the fixture holding the base shell 100 and inner sleeve 210 is secured to the rotating shaft of a welding machine. As the fixture rotates with the rotating shaft, the welding head of the welding machine can perform spot welding. This welds the inner sleeve 210 and the inner convex ring 110 at their contact point, ultimately achieving a fixed connection between the inner sleeve 210 and the inner convex ring 110 by welding.

[0059] S340: Weld the end of the outer sleeve 220 closest to the base shell 100 to the outer convex ring 120. Specifically, the base shell 100 and the outer sleeve 220 can be first fixed by a clamp, and then the end of the outer sleeve 220 closest to the base surface 131 can be welded to the outer convex ring 120. After the base shell 100 and the outer sleeve 220 are fixed by the clamp, the clamp holding the base shell 100 and the outer sleeve 220 is fixed to the rotating shaft of a welding machine. The welding head of the welding machine can perform laser spot welding to weld the outer sleeve 220 and the outer convex ring 120 at the contact point, thereby finally achieving a fixed connection between the outer sleeve 220 and the outer convex ring 120 by welding.

[0060] S350, the end of the inner sleeve 210 welded to the inner convex ring 110 away from the base 130 and the end of the outer sleeve 220 welded to the outer convex ring 120 away from the base 130 are welded. Specifically, after the inner sleeve 210 and the outer sleeve 220 are welded to the base shell 100, the other ends of the inner sleeve 210 and the outer sleeve 220 away from the base surface 131 are welded. Without the use of a fixture, the base shell 100 with the inner sleeve 210 and the outer sleeve 220 welded thereto can be directly placed on a welding workbench. The welding head of the welding machine can perform laser spot welding to weld the inner sleeve 210 and the outer sleeve 220 at their contact point, ultimately achieving a fixed connection of the inner sleeve 210 and the outer sleeve 220 by welding.

[0061] During the laser spot welding process, the laser parameters can be reasonably set to improve the welding strength and welding efficiency. For example, the peak power of the laser is 1.2kw to 1.4kw, and the specific value of the peak power can be 1.2kw, 1.3kw, or 1.4kw. The frequency of the laser is 6HZ to 9HZ, and the specific value of the frequency can be 6HZ, 7HZ, or 9HZ. The energy of a single pulse laser is 1.56J to 7.15J, and the specific value of the energy of a single pulse laser can be 1.56J, 2.30J, or 7.15J. The pulse width of a single pulse laser can be 1.2ms to 2ms, and the specific pulse width of a single pulse laser can be 1.2ms, 1.8ms, or 2ms.

[0062] In some embodiments, for example, step S330, step S340, and step S350 are performed sequentially in chronological order, i.e., step S330 is performed first, step S340 is performed second, and step S350 is performed last. For another example, step S340, step S330, and step S350 are performed sequentially in chronological order, i.e., step S340 is performed first, step S330 is performed second, and step S350 is performed last. Therefore, it is sufficient to ensure that step S350 is performed after step S330 and step S340 in chronological order.

[0063] In the manufacturing method of the above embodiment, since step S350 is always located after step S330 and step S340, the conduit 200 is not connected to form a whole during the welding process with the base shell 100, thereby effectively avoiding over-positioning of the conduit 200 in its own axial direction. This eliminates the welding stress applied by the conduit 200 to the base shell 100 along the axial direction of the conduit 200, thereby eliminating the welding stress along the axial direction of the conduit 200 on the base surface 131. After step S330 is completed, the welding stress will extend along the radial direction of the conduit 200, thereby reducing or eliminating the effect of the welding stress on the flatness of the base surface 131, and ultimately improving the flatness of the base surface 131. After measurement and analysis, refer to Figure 11 、 Figure 12 Table 2 shows the measured flatness values ​​of base surface 131. This table indicates that the flatness of base surface 131 is 0.018 mm, less than 0.045 mm, and therefore well meets design requirements. Since the flatness of base surface 131 well meets design tolerance requirements, the inner cavity of base housing 100 will not be compressed, preventing friction between the impeller and base housing 100, thus avoiding serious events such as hemolysis and ultimately improving the safety of the blood pump.

[0064] Table 2

[0065]

[0066] Furthermore, given that both the inner sleeve 210 and the outer sleeve 220 have annular grooves 230 , and a reasonably small distance is maintained between the annular grooves 230 and the base surface 131 , this will further release welding stress and prevent the base surface 131 from deforming and affecting the flatness of the base surface 131 .

[0067] In some embodiments, before the above steps S330 and S340, there is a step of cleaning and drying the base shell 100, the inner sleeve 210 and the outer sleeve 220. The cleaning and drying steps mainly include the following sub-steps:

[0068] First, a mixture of cleaning liquid and pure water is provided, with a volume ratio of the cleaning liquid to the pure water ranging from 18:1 to 22:1. Specifically, the volume ratio of the cleaning liquid to the pure water can be 18:1, 20:1, or 22:1. The mixed liquid is used to perform a rough cleaning of the base shell 100, the inner sleeve 210, and the outer sleeve 220 using ultrasonic cleaning for 8 to 12 minutes. Specifically, the rough cleaning time can be 8 minutes, 10 minutes, or 12 minutes.

[0069] Next, the base shell 100, inner sleeve 210, and outer sleeve 220 that have undergone rough cleaning are sequentially subjected to multiple passes of fine cleaning. Each pass of fine cleaning uses pure water and ultrasonic cleaning, and each pass of fine cleaning lasts for 8 to 12 minutes. The specific value of each fine cleaning time can be 8 minutes, 10 minutes, or 12 minutes. For example, the base shell 100, inner sleeve 210, and outer sleeve 220 can undergo three passes of fine cleaning.

[0070] Finally, the base shell 100, inner sleeve 210, and outer sleeve 220, which have undergone multiple fine cleanings, are dried. Specifically, the base shell 100, inner sleeve 210, and outer sleeve 220 can be placed in a drying oven for drying at a temperature of 70°C to 75°C, with specific values ​​of 70°C, 72°C, or 75°C being possible. The drying time is 10 to 12 minutes, with specific values ​​of 10 minutes, 11 minutes, or 12 minutes being possible.

[0071] Therefore, the base shell 100 , the inner sleeve 210 and the outer sleeve 220 that have been cleaned and dried can effectively prevent the influence of dirt and moisture on the welding during the subsequent welding process, thereby improving the welding strength between the various components.

[0072] In some embodiments, the rough cleaning and the fine cleaning are performed in different cleaning tanks, and multiple passes of fine cleaning are performed in different cleaning tanks. For example, if the base shell 100, the inner sleeve 210, and the outer sleeve 220 undergo three passes of fine cleaning, multiple cleaning tanks may be provided, and the cleaning tanks may be labeled "rough cleaning tank," "fine cleaning tank for the first pass," "fine cleaning tank for the second pass," and "fine cleaning tank for the third pass." The base shell 100, the inner sleeve 210 and the outer sleeve 220 are roughly cleaned in the "rough cleaning tank"; when the rough cleaning is completed, the base shell 100, the inner sleeve 210 and the outer sleeve 220 are transferred to the "first fine cleaning tank" for the first fine cleaning; when the first fine cleaning is completed, the base shell 100, the inner sleeve 210 and the outer sleeve 220 are transferred to the "second fine cleaning tank" for the second fine cleaning; when the second fine cleaning is completed, the base shell 100, the inner sleeve 210 and the outer sleeve 220 are transferred to the "third fine cleaning tank" for the third fine cleaning, and finally the rough cleaning and multi-pass fine cleaning of the base shell 100, the inner sleeve 210 and the outer sleeve 220 are achieved.

[0073] In other embodiments, the rough cleaning and multiple fine cleanings are both completed in the same cleaning tank; after the previous cleaning is completed, the waste liquid in the cleaning tank is drained, and pure water is injected into the cleaning tank to complete the next cleaning. For example, in the case where the base shell 100, the inner sleeve 210, and the outer sleeve 220 undergo three fine cleanings, only one cleaning tank can be provided. After the base shell 100, the inner sleeve 210, and the outer sleeve 220 complete the rough cleaning, the waste liquid in the cleaning tank is drained, and then pure water is injected into the cleaning tank for the first time to perform the first fine cleaning; after the first fine cleaning is completed, the waste liquid in the cleaning tank is drained, and then pure water is injected into the cleaning tank for the second time to perform the second fine cleaning; after the second fine cleaning is completed, the waste liquid in the cleaning tank is drained, and then pure water is injected into the cleaning tank for the third time to perform the third fine cleaning, thereby finally achieving rough cleaning and multiple fine cleaning of the base shell 100, the inner sleeve 210, and the outer sleeve 220.

[0074] In some embodiments, after step S350 , the end of the inner sleeve 210 away from the base surface 131 may be polished, and the end of the outer sleeve 220 away from the base surface 131 may also be polished to improve the smoothness of the entire catheter 200 .

[0075] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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.

[0076] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A blood pump, characterized in that: The blood pump comprises a housing assembly and an impeller, wherein the housing assembly comprises: A base shell, comprising a base, an inner convex ring, and an outer convex ring, wherein the impeller is at least partially accommodated in an inner cavity surrounded by the base, the inner convex ring and the outer convex ring are both convexly disposed on the base, and the outer convex ring is disposed around the inner convex ring, the base having a base surface, and the inner convex ring and the outer convex ring are both connected to the base surface; and The catheter includes an inner sleeve and an outer sleeve, the outer sleeve is arranged around the inner sleeve, the end of the inner sleeve close to the base is welded to the inner convex ring, the end of the outer sleeve close to the base is welded to the outer convex ring, the end of the inner sleeve welded to the inner convex ring away from the base and the end of the outer sleeve welded to the outer convex ring away from the base are welded.

2. The blood pump according to claim 1, characterized in that The inner convex ring includes a first inner ring and a second inner ring arranged coaxially, the first inner ring is closer to the base than the second inner ring, the thickness of the first inner ring is greater than the thickness of the second inner ring, so as to form a step surface at the end of the first inner ring, the second inner ring is connected to the first inner ring and is arranged around the step surface, the inner sleeve is in contact with the step surface, and the second inner ring is sleeved on the inner sleeve.

3. The blood pump according to claim 2, characterized in that The inner sleeve includes a first inner tube and a second inner tube arranged coaxially, the first inner tube is farther away from the base than the second inner tube and is connected to the outer sleeve, the end of the first inner tube has an inner limit surface, the second inner tube is connected to the end of the first inner tube, the inner limit surface is arranged around the second inner tube, the end of the second inner tube abuts the step surface, the second inner ring is sleeved outside the second inner tube, and the end of the second inner ring maintains a set distance or abuts against the inner limit surface.

4. The blood pump according to claim 1, wherein The outer sleeve includes a first outer tube and a second outer tube arranged coaxially, the first outer tube is farther away from the base than the second outer tube, the end of the first outer tube has an outer limiting surface, the second outer tube is connected to the end of the first outer tube, the outer limiting surface is arranged around the second outer tube, the outer convex ring is sleeved outside the second outer tube, and the end of the outer convex ring abuts against the outer limiting surface.

5. The blood pump according to claim 1, wherein A first annular groove is formed on the outer surface of the inner sleeve, and the first annular groove is arranged around the central axis of the inner sleeve; and / or a second annular groove is formed on the inner side surface of the outer sleeve, and the second annular groove is arranged around the central axis of the outer sleeve.

6. The blood pump according to claim 1, characterized in that A first annular groove is formed in a depression on the outer surface of the inner sleeve, the first annular groove is arranged around the central axis of the inner sleeve, and the base surface is closer to the first annular groove relative to the end of the inner sleeve away from the base surface; and / or a second annular groove is formed in a depression on the outer surface of the outer sleeve, the second annular groove is arranged around the central axis of the outer sleeve, and the base surface is closer to the second annular groove relative to the end of the outer sleeve away from the base surface.

7. A method for manufacturing a blood pump, characterized in that: The blood pump comprises a housing assembly and an impeller, and the manufacturing method comprises the steps of: A base shell is provided, the base shell comprising a base body, an inner convex ring, and an outer convex ring, the impeller being at least partially accommodated in an inner cavity surrounded by the base body, the inner convex ring and the outer convex ring both being convexly disposed on the base body, the outer convex ring being disposed around the inner convex ring, the base body having a base surface, the inner convex ring and the outer convex ring both being connected to the base surface; Providing a catheter, the catheter comprising an inner cannula and an outer cannula, the outer cannula being disposed around the inner cannula; Welding one end of the inner sleeve close to the base shell to the inner convex ring; Welding one end of the outer sleeve close to the base shell to the outer convex ring; and The end of the inner sleeve welded to the inner convex ring away from the base body and the end of the outer sleeve welded to the outer convex ring away from the base body are welded.

8. The manufacturing method according to claim 7, characterized in that Before welding the end of the inner sleeve close to the base shell to the inner convex ring, the manufacturing method further includes: Providing a mixture of cleaning liquid and pure water, wherein the volume ratio of the cleaning liquid to the pure water is 18:1 to 22:1, and performing a rough cleaning of the base shell and the conduit for 8 minutes to 12 minutes using the mixture; Perform multiple passes of fine cleaning on the base shell and the conduit, with each pass of fine cleaning lasting 8 to 12 minutes; The base shell and the conduit are dried, wherein the drying temperature is 70° C. to 75° C. and the drying time is 10 min to 12 min.

9. The manufacturing method according to claim 7, characterized in that: The welding method is laser spot welding, wherein the laser parameters are as follows: peak power of 1.2 kW to 1.4 kW, frequency of 6 Hz to 9 Hz, single pulse laser energy of 1.56 J to 7.15 J, and pulse width of 1.2 ms to 2 ms.

10. The manufacturing method according to claim 7, characterized in that: After welding the end of the inner sleeve away from the base and the end of the outer sleeve away from the base, the manufacturing method further includes: grinding the end of the inner sleeve away from the base and the end of the outer sleeve away from the base.

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