Blood window for catheter pump and capable of minimizing thrombus formation, manufacturing method of blood window and catheter pump

Abstract

The blood window comprises a connecting part, a tip located at the far end of the connecting part, a plurality of supporting columns connected between the connecting part and the tip and a sensor comprising a sensing head, and an opening for blood circulation is defined between every two adjacent supporting columns. The end head is provided with a cavity channel, the sensing head is arranged in the cavity channel, and the side wall of the end head is provided with a through hole communicated with the cavity channel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a blood window, a manufacturing method thereof, and a catheter pump. Background Art

[0002] After the catheter pump is inserted into the patient's heart, the inlet pointing to the apex is a key indicator for the normal positioning of the catheter pump. However, in practice, due to various factors, it is difficult to achieve the above ideal state. For example, during the operation of the catheter pump, the heart is still beating, resulting in the axial movement of the catheter pump within the ventricle. Or, due to the stress rebound of the catheter, the catheter pump is offset to one side in the heart valve rather than passing through the center of the valve.

[0003] The poor positioning of the catheter pump often causes the ventricular wall tissue to be sucked into the inlet. In addition, the applicant's latest research found that when a sensor is configured at a position close to the inlet of the catheter pump, the poor positioning of the catheter pump will cause the mitral valve to reciprocate and beat into the inlet, resulting in the free chordae tendineae on the mitral valve being cut off by the side wall of the inlet and blocking the sensor.

[0004] As disclosed in the prior art US9669142B2, the sensing head of the sensor sinks into the pit on the far side of the blood inlet, and a convex portion in the shape of a dot or a U shape is provided on its far side to protect the sensing head from being damaged by collision during the insertion of the blood pump into the patient's body. However, in this solution, the sensing head is set in an exposed manner. Although there is a convex portion to protect its distal end, this convex portion mainly plays a protective role during the insertion of the pump. During the operation of the pump, when the positioning of the pump in the ventricle is poor, the free chordae tendineae in the ventricle will still enter between the convex portion and the sensing head, thereby causing the sensor to be blocked, or a thrombus to form between the two, and further causing the pressure-sensitive surface of the sensor to be blocked, resulting in the failure of pressure detection. Summary of the Invention

[0005] The present invention provides a blood window, a manufacturing method thereof, and a catheter pump, aiming to solve the problem that the sensing head of the traditional catheter pump is easily blocked by the heart inner wall tissue or forms a thrombus.

[0006] The blood window includes a connecting portion, a head at the distal end of the connecting portion, a plurality of struts connected between the connecting portion and the head, and a sensor including a sensing head. An opening for blood flow is defined between adjacent two struts. The head is provided with a cavity, the sensing head is arranged in the cavity, and a through hole communicating with the cavity is provided on the side wall of the head.

[0007] The method for manufacturing the blood window includes: placing the sensor in the cavity; injecting an adhesive material into the cavity and performing a curing operation.

[0008] The catheter pump includes the blood window as described above; or the blood window manufactured by the method as described above. Brief Description of the Drawings

[0009] Figure 1 Schematic diagram of the catheter pump of the present invention applied to left ventricular assistance;

[0010] Figure 2 Three-dimensional view of the blood window;

[0011] Figure 3 Cross-sectional view of the first embodiment of the blood window;

[0012] Figure 4 Cross-sectional view of the second embodiment of the blood window;

[0013] Figure 5 Cross-sectional view of the third embodiment of the blood window;

[0014] Figures 6A to 7 Schematic diagram of the process of manufacturing the blood window of the first embodiment;

[0015] Figures 8 to 11 Schematic diagram of the process of manufacturing the blood window of the second embodiment;

[0016] Figure 12 Fluid simulation diagram of the blood window with different through-hole configurations;

[0017] Figure 13 For Figure 12 Flow velocity comparison diagram after normalizing the flow velocity of the fluid simulation. Detailed implementation manners

[0018] The terms "proximal" and "distal" are relative to the doctor operating the catheter pump 100. "Proximal" refers to the part relatively closer to the doctor, and "distal" refers to the part relatively farther from the doctor. For example, the catheter 110 is located at the proximal end of the pump assembly 120, and the pump assembly 120 is located at the distal end of the catheter 110. It should be understood that these orientation terms are defined for convenience of description and are not restrictive and absolute.

[0019] Such as Figure 1As shown, the catheter pump 100 includes a catheter 110, a pump assembly 120, and a controller 150 located outside the patient's body for controlling the operation of the pump assembly 120. The pump assembly 120 includes a motor 140 connected to the distal end of the catheter 110, a blood window 122 connected to the distal end of the motor 140, an intubation tube 121 connected to the distal end of the blood window 122, a blood window 123 connected to the distal end of the intubation tube 121, a protection structure 124 (including a flexible hollow pigtail tube with a rounded or coiled end in its natural state or a round head structure with a smooth outer surface) connected to the distal end of the blood window 123 for preventing damage to the blood vessels and the inner wall tissue of the left ventricle LV, and an impeller (not shown) located in the blood window 122 and driven by the motor 140 to rotate for pumping blood. Openings 120a and 120b are respectively provided on the side walls of the blood windows 122 and 123. One of the openings 120a and 120b constitutes the blood inlet, and the other constitutes the blood outlet, depending on the applicable scenario of the catheter pump 100. When the catheter pump 100 is used for left ventricular assistance, the opening 120a is the blood outlet, and the opening 120b is the blood inlet. When the catheter pump 100 is used for right ventricular assistance, the opening 120a is the blood inlet, and the opening 120b is the blood outlet.

[0020] Taking the catheter pump 100 used for left ventricular assistance as an example, the doctor inserts the pump assembly 120 into the patient's body through a puncture opening made in the patient's skin, pushes the catheter 110 forward, and the pump assembly 120 moves forward in the patient's body until the distal end of the pump assembly 120 passes through the aortic valve AV and enters the left ventricle LV, so that the intubation tube 121 straddles the aortic valve AV, the opening 120b is located in the left ventricle LV, and the opening 120a is located in the aorta AO. The impeller rotates to suck the blood in the left ventricle LV through the opening 120b into the intubation tube 121 and pump it out through the opening 120a to the aorta AO to assist the heart's pumping function and reduce the heart burden.

[0021] That is to say, the catheter pump 100 of this embodiment is not only applicable to the scenario of left ventricular assistance, but also applicable to the scenario of right ventricular assistance (the opening 120a is located in the right ventricle, and the opening 120b is located in the pulmonary artery). Of course, it can also be applicable to the assistance of the kidneys as a renal pump. The following mainly describes the catheter pump 100 used as the main scenario of left ventricular assistance, but based on the above description, the protection scope of this embodiment is not limited thereby.

[0022] The pump assembly 120 further includes a distal sensor 240 adjacent to the opening 120b, and may also include a proximal sensor 130 adjacent to the opening 120a. After the pump assembly 120 is correctly positioned, the sensor 240 is used to measure the actual pressure LVP in the position (left ventricle LV) where the opening 120b is located, and the sensor 130 is used to measure the actual pressure AOP in the position (aorta AO) where the opening 120a is located.

[0023] A cable 160 is threaded through the conduit 110 to electrically and signal - connect the pump assembly 120 and the controller 150. The cable 160 includes wires connected to the motor 140 for transmitting an electrical signal to drive the rotation of the motor 140. The cable 160 also includes sensing cables connected to the sensors 130 and 240 for transmitting the signals measured by the sensing heads of the sensors 130 and 240 to the controller 150. The controller 150 can store the electrical signal for driving the motor 140 and the pressure signals measured by the sensors 130 and 240 in a memory, and can associate the electrical signal and the pressure signal with time and display them on a display screen.

[0024] The sensors 130 and 240 can adopt any suitable existing structures, including but not limited to piezoelectric pressure sensors, piezoresistive pressure sensors, optical pressure sensors, etc., and this embodiment does not limit this. The corresponding sensing cables for the above - mentioned various types of pressure sensors are cables, cables, and optical fibers respectively. Below, the main scenario is described with the sensors 130 and 240 being optical pressure sensors and the sensing cables being optical fibers. The protection scope of this embodiment is not limited thereby.

[0025] Please refer to Figures 2 to 4 , the blood window 200 provided by the present invention for the above - mentioned catheter pump 100 is the blood window 122, which includes a connecting portion 210, a head 220, a plurality of struts 230 arranged at intervals in the circumferential direction, and a sensor 240. The head 220 is located at the distal end of the connecting portion 210. The struts 230 are connected between the connecting portion 210 and the head 220. An opening 231 (corresponding to the opening 120b) is defined between two adjacent struts 230. The head 220 is provided with a cavity 221. The sensing head 241 of the sensor 240 is at least partially disposed in the cavity 221, so that the pressure - sensitive surface 241a at the distal end of the sensing head 241 is located in the cavity 221. A through - hole 222 communicating with the cavity 221 is provided on the side wall of the head 220.

[0026] By burying the sensing head 241 in the cavity 221, it can be avoided that the catheter pump 100 is scratched by the inner wall of the blood vessel or the sensing head 241 is damaged by collision during the intervention process. In addition, by opening the through - hole 222 on the side wall of the head 220, with the communication effect of the through - hole 222 and the cavity 221, during the operation of the catheter pump 100, blood is introduced into the cavity 221 from the through - hole 222 to wash the pressure - sensitive surface 241a of the sensing head 241. While achieving the purpose of blood pressure detection, the blood flushing effect is used to prevent the formation of thrombus on the pressure - sensitive surface 241a due to the slow blood flow velocity, and it can also avoid the blockage of the pressure - sensitive surface 241a by the inner ventricular wall tissues such as free chordae tendineae, mitral valve, etc.

[0027] The connecting portion 210 is generally cylindrical and is used to connect with the cannula 121. The end 220 is generally in the shape of a water droplet with a gradually larger outer diameter from near to far, and is used to connect with the protection structure 124. Each strut 230 is arranged at equal intervals in the circumferential direction to form a plurality of openings 231 with substantially the same structure. The cavity 221 extends in a long shape from near to far and is axially aligned with one of the struts 230. A groove 221a is formed on the outer wall of the strut 230 axially aligned therewith. The groove 221a is axially aligned and communicated with the cavity 221 for the optical fiber 242 of the sensor 240 to pass through.

[0028] As Figures 2 to 5 shown, the end 220 is provided with a guiding channel 223 that axially penetrates and is used for the guide wire guiding tube to movably pass through. The cavity 221 extends obliquely gradually in the direction approaching the guiding channel 223 from near to far. The cavity 221 that is inclined inward from near to far helps to form a cavity 221 with sufficient length in the end 220 to accommodate the sensing head 241, and the inclined distal inner wall 221a formed thereby preferably stops and positions the sensing head 241 in the cavity 221 and guides the sensing head 241 to incline towards the guiding channel 223. In this way, the sensing head 241 can be stably fixed in the cavity 221 and will not pop out of the cavity 221 due to the resilience generated by the bending of the optical fiber 242. In addition, the inclined cavity 221 makes the outer distal end point of the sensing head 241 abut against the distal inner wall 221a, preventing the distal pressure-sensitive surface 241a of the sensing head 241 from contacting the distal inner wall 221a, preventing mechanical damage to the fragile pressure-sensitive surface 241a, and ensuring that the pressure-sensitive surface 241a is always unobstructed and in communication with the blood to achieve accurate measurement of blood pressure. Moreover, the inclined cavity 221 enables the optical fiber 242 connected to the sensing head 241 to have a smooth transition, avoiding violent bending of the optical fiber 242, reducing the bending angle of the optical fiber 242, and reducing the risk of fragmentation of the hard and brittle optical fiber 242.

[0029] The aspect ratio of the guiding channel 223 is small, resulting in a large resistance to blood passage and easy retention of blood during the operation of the catheter pump 100, which is likely to form blood clots or coagulation. In view of this, the guiding channel 223 is configured to communicate with the through hole 222. The specific communication method is that the through hole 222 is opened on the side wall of the end 220 and forms an outer end orifice located on the outer wall of the end 220. As Figure 3 and Figure 4 shown, in one embodiment, the inner end orifice is formed at the inner wall where the cavity 221 intersects with the guiding channel 223, and the through hole 222 is directly communicated with the cavity 221 and the guiding channel 223 through the inner end orifice. Or, as Figure 5As shown, in another embodiment, the inner end orifice is formed on the side wall of the guiding channel 223 and is offset from the cavity 221. The through hole 222 is directly connected to the guiding channel 223 through the inner end orifice, and is indirectly connected to the cavity 221 through the guiding channel 223. Alternatively, in yet another embodiment, the inner end orifice is formed on the inner wall of the cavity 221 and is offset from the guiding channel 223 (not shown). The through hole 222 is directly connected to the cavity 221 through the inner end orifice, and is indirectly connected to the guiding channel 223 through the cavity 221.

[0030] By providing that the through hole 222 is connected to the guiding channel 223, when blood enters through the through hole 222, the suction force in the guiding channel 223 directly or indirectly connected thereto is increased, promoting the flow of blood therein (specifically, blood enters the cavity 221 and the guiding channel 223 through the through hole 222 and flows out from the openings at both ends of the guiding channel 223), avoiding low blood flow velocity or even blood flow dead zones in the guiding channel 223, and thus preventing the formation of blood clots or coagulation. Moreover, during this process, the blood continuously flushes the pressure-sensitive surface 241a, preventing the formation of blood clots on the pressure-sensitive surface 241a.

[0031] Taking the cavity 221 as a reference, the through hole 222 can be classified into different types according to its orientation. For example, in the embodiments shown in Figure 2 and Figure 3 , the through hole 222 penetrates through the radial two sides of the end head 220, such that the two outer end orifices of the through hole 222 are located on the left and right sides of the cavity 221 (hereinafter referred to as the side hole scheme). Or, in the embodiments shown in Figure 4 and Figure 5 , the through hole 222 penetrates through the side of the end head 220 facing away from the cavity 221 to form an outer end orifice, and the outer end orifice and the cavity 221 are respectively located on the radial two sides of the end head 220 (hereinafter referred to as the bottom hole scheme). The through hole 222 can adopt any of the above embodiments, or can adopt the superposition of at least two embodiments. For example, as shown in Figure 2 and Figure 3 , Figure 5 respectively show the schemes with only side holes and only bottom holes, while Figure 4 shows the combined scheme of side holes + bottom holes.

[0032] Taking the guiding channel 223 as a reference, the through hole 222 can be further classified into a straight hole scheme and an inclined hole scheme. In the embodiments shown in Figure 2 and Figure 3 , the through hole 222 is disposed substantially perpendicular to the guiding channel 223 at 90°, then the through hole 222 in this embodiment is a straight hole scheme. As shown in Figure 4In the combination scheme of the side holes + bottom holes shown, the through holes 222 perpendicular to the paper plane and the through holes 222 vertically extending on the paper plane are both disposed at approximately 90° perpendicular to the guiding channel 223. Thus, the two through holes 222 in this embodiment are also both straight hole schemes. And in the embodiment as shown in Figure 5 , the through hole 222 extends obliquely in a direction gradually away from the guiding channel 223 from near to far. Thus, the through hole 222 in this embodiment is an inclined hole scheme. Of course, the through hole 222 can also adopt a combination scheme of straight holes + inclined holes (not shown). For example, modifying the through hole 222 vertically extending on the paper plane in Figure 4 to an inclined hole as shown in Figure 5 can obtain this combination scheme.

[0033] In summary, Figure 2 and Figure 3 show the side and straight hole schemes, Figure 4 shows the side, bottom and straight hole schemes, Figure 5 shows the bottom and inclined hole schemes.

[0034] It should be noted that in this specification, "substantially" can be understood as close to, approximate, or within a predetermined range of difference from the target value. For example, the through hole 222 being disposed at approximately 90° perpendicular to the guiding channel 223 can mean that the difference between the angle between the two and 90° is within 5% of the range, and further within 2% of the range. The same understanding can be made for "substantially" described below, and will not be elaborated further.

[0035] As shown in Figure 12 , when blood is inhaled into the opening 231, it is distributed substantially radially. Therefore, the blood basically impacts the end head 220 at an angle inclined to the axis. Thus, in order to maximize the utilization of the impact kinetic energy of the blood and reduce the shear stress brought by the impact to the blood, in the embodiment where the through hole 222 is an inclined hole, the inclination angle is between 30° and 60°, and further between 40° and 50°, such as 43°, 45°, 47°. Among them, the inclination angle is the angle between the axis of the through hole 222 and the axis of the blood window 200. In this way, the direction of the through hole 222 is basically the same as the direction in which the blood is inhaled into the opening 231, thereby maximizing the speed of blood flushing the guiding channel 223 and reducing the risk of blood coagulation or blood clots forming in the guiding channel 223. And, the inclined direction of the through hole 222 conforms to the direction of the blood entering the opening 231, which can reduce the impact force of the blood colliding with the through hole 222 and reduce blood damage.

[0036] As shown in Figure 12 , the applicant adopted through holes 222 of different configuration types for the blood window 200, and through flow simulation and Min - Max normalization processing of the blood flow velocity in the guiding channel 223, obtained as shown in Figure 13The normalized maximum flow rate comparison diagram shown. Among them, Figure 12 (a) shows the case where the blood window 200 does not have a through hole, Figure 12 (b) is Figure 3 the embodiment shown, Figure 12 (c) is Figure 4 the embodiment shown, Figure 12 (d) is Figure 5 the embodiment shown. It can be seen that, compared with the design of the blood window 200 without through holes, the through hole 222 can significantly increase the blood flow rate in the guiding channel 223, and increasing the number of through holes 222 can further improve the blood flow rate in the guiding channel 223, and the inclined through hole 222 is more beneficial for increasing the blood flow rate in the guiding channel 223.

[0037] A filling material 250 for fixing the sensing head 241 is provided in the channel 221. A gap is formed between the outer wall of the sensor 240 and the inner wall of the channel 221, and the filling material 250 completely fills the gap to ensure that the sensor 240 is fixed relative to the end 220. The filling material 250 is flush with the outer surface of the end 220 to ensure that the outer surface of the end 220 is smooth and fluent, avoiding scratching the blood vessel and the inner wall of the tissue during the intervention process, and avoiding causing shear stress to the blood during the operation of the pump to form thrombus.

[0038] The filling material 250 is formed by curing an adhesive material 260 with fluidity, and the fluidity of the adhesive material 260 ensures that it can fill the above-mentioned gap. As Figures 6A to 7 shown, the filling material 250 can be formed only by curing one adhesive material 260. Or, as Figures 3 to 5 、 Figures 8 to 11 shown, the filling material 250 is formed by curing two adhesive materials 260, including a first filling material 251 located inside and formed by curing a first adhesive material 261 and a second filling material 252 located outside and formed by curing a second adhesive material 262. The hardness of the filling material 251 is less than the hardness of the filling material 252 (for example, the hardness of the filling material 251 is Shore D 20-40, and the hardness of the filling material 252 is Shore D80-95). In this way, the filling material 252 with greater hardness forms a part of the outer surface of the end 220, preventing surface damage caused by being scratched by the inner wall of the blood vessel and the inner wall of the ventricle during the intervention process of the catheter pump 100 and during the working process. Surface damage will cause the filling material 252 to be uneven, which is not conducive to hemolysis. Moreover, the filling material 252 with higher hardness provides the possibility of grinding to eliminate the height difference between its surface and the outer surface of the end 220 (introduced below), and avoids leaving scratches on its surface or being taken out of the channel 221 as a whole during grinding.

[0039] As Figures 6A to 11 shown, the method for manufacturing the blood window 200 includes:

[0040] Step S100: Place the sensor 240 in the cavity 221.

[0041] Step S200: Inject the bonding material 260 into the cavity 221 and perform a curing operation.

[0042] In this embodiment, first, obtain the tip 220 and the sensor 240 with the above characteristics. Subsequently, place the sensing head 241 of the sensor 240 into the cavity 221, and the outer distal end of the sensing head 241 abuts against the distal inclined side wall 221a of the cavity 221 to initially position the sensing head 241 in the cavity 221. Then, inject the bonding material 260 into the cavity 221 and perform a curing operation. The curing operation can be matched with the type of the bonding material 260, such as natural curing at room temperature, heat curing, light curing with a specified wavelength band, etc.

[0043] As Figures 6A to 7 shown, in one embodiment, the bonding material 260 is only one type, such as AB glue, and finally, a single filling material 250 is obtained after curing. For the convenience of injecting the bonding material 260, the blood window 200 is initially in a substantially horizontal state, as Figure 6A shown, that is, the guiding channel 223 extends substantially in the horizontal direction, and the cavity 221 is in the upper side or facing upward state. At this time, injecting the bonding material 260 into the cavity 221 can ensure that the bonding material 260 can flow naturally into the cavity 221 and prevent the bonding material 260 from leaking out.

[0044] To control the flow depth of the bonding material 260 in the cavity 221 and avoid the bonding material 260 covering the pressure-sensitive surface 241a due to excessive flow, as Figure 6AAs shown, in one embodiment, a hollow mandrel 300 can be pre-inserted into the through hole 222. The side wall of the mandrel 300 is provided with air holes 310 corresponding to the cavity 221, and both ends of the guiding channel 223 are blocked (for example, blocked by the material 400). During the process of injecting the bonding material 260 into the cavity 221, the horizontal state of the blood window 200 is maintained, and gas is introduced through the mandrel 300, so that the gas blows towards the bonding material 260 in the cavity 221 through the air holes 310. Since both ends of the guiding channel 223 are blocked, the gas injected from the air holes 310 forms a stable pressure atmosphere greater than the external air pressure in the cavity 221 and the guiding channel 223. Therefore, this operation of applying gas to the bonding material 260 while injecting the bonding material 260 can, on the one hand, partially resist the gravitational force, effectively prevent the bonding material 260 from flowing too deeply into the guiding channel 223 and the through hole 222, resulting in the bonding material 260 covering the pressure-sensitive surface 241a of the sensing head 241, and ensure that the pressure-sensitive surface 241a can maintain the exposed state required for detection. On the other hand, when the gas is a hot air flow, it can pre-cure the bonding material 260, reduce the too-fast flow of the bonding material 260 deep into the cavity 221, and facilitate the positioning of the bonding material 260 at a position close to the pressure-sensitive surface 241a. Or, as Figure 6B As shown, in another embodiment, after injecting the bonding material 260, the blood window 200 can be adjusted from the horizontal state to the vertical state or the inclined state. Among them, the vertical state is that the guiding channel 223 extends substantially in the vertical direction, and the distal end of the blood window 200 faces upward and the proximal end faces downward. The inclined state is that the cavity 221 is located on the upper side and its outer end opening is inclined downward. In this way, the vertical or inclined blood window 200 can partially offset the gravitational force and prevent the bonding material 260 from flowing too deeply into the guiding channel 223.

[0045] After the bonding material 260 has basically lost its fluidity, it is considered that the pre-curing is completed, which can be simply estimated by the pre-curing time. Subsequently, after removing the blockage of the material 400 and adjusting the blood window 200 to the vertical state or the inclined state, a secondary curing process is performed, such as curing in an oven.

[0046] The injection amount of the bonding material 260 is configured to overflow the outer end opening of the cavity 221. An appropriately excessive amount of the bonding material 260 is used to provide a redundant material configuration to avoid poor fixing effects and the formation of pits after the material is cured. After the bonding material 260 is cured, a protrusion is formed at the outer end opening of the cavity 221, as shown in Figure 6A and Figure 6B the part shown outside the dotted line at the bonding material 260 or the filling material 250 in. Therefore, after the bonding material 260 is cured, the protruding part of the filling material 250 that overflows to the outer end opening of the cavity 221 is polished until the filling material 250 is flush with the outer surface of the end 220, obtaining asFigure 7 The final blood window 200 shown.

[0047] As Figures 8 to 11 shown, in another embodiment, the bonding material includes two types: bonding materials 261 and 262, and two filling materials: filling materials 251 and 252 are finally obtained by curing. Similarly, as Figure 8 shown, for the convenience of injecting the bonding material, the bonding material 261 is first injected into the channel 221 when the blood window 200 is basically in a horizontal state. As Figure 9A , Figure 9B or Figure 9C shown, then a curing operation is performed on the bonding material 261. As Figure 10 shown, after the bonding material 261 is at least partially cured, the bonding material 262 is injected into the channel 221, and a curing operation is performed on the bonding material 262.

[0048] In this embodiment, the curing speed of the bonding material 261 is greater than that of the bonding material 262, which makes the bonding material 261 more likely to be at least partially cured within a very short time (e.g., within 2 s) when subjected to curing conditions (e.g., as Figure 9A shown by irradiating with UV light 170), so as to quickly achieve the pre-fixation of the sensing head 241, facilitate the injection and curing operations of the bonding material 262, and prevent the sensing head 241 and the optical fiber 242 from shifting during the injection and / or curing of the bonding material 262.

[0049] Due to this expectation of pre-fixation for the bonding material 261, its filling amount should be less than that of the bonding material 262 (e.g., the two are filled in a ratio of 1:9 to 4:6). The bonding material 261 with a smaller filling amount is more conducive to rapid curing, while the bonding material 262 with a larger filling amount results in a harder filling material 252 after curing, which is beneficial to improving the fixing strength of the sensing head 241 and the protection effects such as earthquake resistance and impact resistance.

[0050] Furthermore, the viscosity of the bonding material 261 is less than that of the bonding material 262 (e.g., the viscosity of the bonding material 262 is about 10 times that of the bonding material 261), so that the bonding material 261 has relatively better fluidity, which can shorten the flow time for the front end of the bonding material 261 to be positioned near the pressure-sensitive surface 241a, and cooperate with its faster curing speed to achieve its rapid curing.

[0051] In addition, the thermal conductivity of the bonding material 261 is inferior to that of the bonding material 262 (for example, the thermal conductivity of the bonding material 261 is 10% - 50% of that of the bonding material 262), but its flexibility is better than that of the bonding material 262. Since the filling amount of the bonding material 262 is larger, and based on the material properties of the bonding material 262, the heat release during its curing process is greater. Therefore, the relatively poor thermal conductivity of the bonding material 261 can play a role in thermal isolation, while its better flexibility after curing can absorb the curing thermal stress of the bonding material 262, thereby reducing or even avoiding the curing thermal stress and heat transfer of the bonding material 262 to the pressure-sensitive surface 241a, preventing the pressure-sensitive surface 241a from being damaged by heat.

[0052] The bonding material 261 meeting the above characteristics includes UV curable adhesives, heat-curable UV adhesives (photo-thermal dual-curing) such as UV adhesives, medical-grade silicone rubbers or instant adhesives, etc., and the bonding material 262 meeting the above characteristics includes epoxy resin AB adhesives, medical polyurethane (PU) adhesives, etc. Among them, UV adhesives and AB adhesives are preferred because they are widely used in the field of medical connections.

[0053] Similarly to the above, to prevent the bonding material 261 from flowing too deeply and covering the pressure-sensitive surface 241a, in one embodiment, as Figure 9A shown, when the blood window 200 is basically in a horizontal state, the bonding material 261 is irradiated with UV light to achieve rapid curing. This curing process does not require changing the position state of the blood window 200, which is beneficial for operation. When the blood window 200 is placed basically horizontally on the operating table without manual interference by the operator, the injection of the UV adhesive and the irradiation of the UV light source 170 on the UV adhesive are carried out seamlessly, so that the glue injection and curing operation efficiency is high and the operation is convenient.

[0054] As Figure 9B shown, in another embodiment, after injecting the bonding material 261, the blood window 200 can be adjusted to a vertical state or an inclined state to prevent the bonding material 261 from flowing too deeply. The bonding material 261 can also be cured in this state through matching curing conditions such as UV light irradiation, hot air gun heating, etc. Or, as shown in 9C, in another embodiment, a hollow mandrel 300 is inserted into the through hole 222 in advance, and the two end ports of the guiding channel 223 are blocked by the material 400. Then, while maintaining the horizontal state of the blood window 200, during the injection of the bonding material 261, purge gas is introduced through the mandrel 300, and the gas is blown towards the bonding material 261 in the cavity 221 through the air holes 310. The purge gas can be hot gas (for example, 80 - 150 °C), which is used to promote the curing of the bonding material 261.

[0055] As Figure 10As shown, after at least partial curing of the bonding material 261, the plug of the material 400 is removed, the blood window 200 is readjusted to a horizontal state, and then the injection of the bonding material 262 and subsequent curing operations (for example, curing in an oven as described above) are performed. The injection amount of the bonding material 262 is also configured to overflow the outer end port of the channel 221. After the filling material 252 is formed by its curing, the portion where the filling material 252 overflows to the outer end port (such as Figure 10 the portion shown outside the dotted line at the bonding material 262 in Figure 11 ) is polished until the filling material 252 is flush with the outer surface of the end 220, obtaining the final blood window 200 as shown in

[0056] The above are only the preferred embodiments of the present invention, and do not limit the scope of the present invention accordingly. Any equivalent structural transformation made under the inventive concept of the present invention by using the content of the specification and drawings of the present invention, or direct / indirect application in other related technical fields, is included in the patent protection scope of the present invention.

Claims

1. A blood window, comprising: Connecting part; A terminal, located at the distal end of the connecting portion; A plurality of pillars arranged at intervals along the circumferential direction, wherein the pillars are connected between the connecting portion and the end head, and an opening for blood to flow through is defined between two adjacent pillars; as well as, Sensors, including sensor heads; Wherein, the end head is provided with a cavity, the sensor head is arranged in the cavity, and the side wall of the end head is provided with a through hole connected to the cavity.

2. The blood window according to claim 1, wherein the end is provided with a guide channel penetrating along the axial direction, and the guide channel is connected with the through hole; Preferably, the cavity extends from near to far in a direction gradually approaching the guide channel.

3. The blood window as described in claim 2, wherein the cavity has an inclined distal inner wall; the sensor head is stopped and limited in the cavity by the distal inner wall so that the pressure-sensitive surface of the sensor head is inclined toward the guide channel.

4. The blood window as claimed in claim 2, wherein the through hole penetrates the radial sides of the end at a direction substantially 90° to the guide channel to form two outer end openings, and the two outer end openings are respectively located on both sides of the cavity; and / or, The through hole penetrates a side of the end facing away from the cavity to form an outer end opening, and the outer end opening and the cavity are arranged on two radial sides of the end; and / or, The through hole extends from near to far and gradually tilts away from the guide channel; Preferably, the inclination angle of the through hole is not less than 30° and not more than 60°; Preferably, the inclination angle of the through hole is not less than 40° and not more than 50°.

5. The blood window according to claim 1, wherein a filling material for fixing the sensor head is provided in the cavity, and the filling material is flush with the outer surface of the end head; Preferably, the filling material includes a first filling material located on the inner side and formed by curing a first adhesive material, and a second filling material located on the outer side and formed by curing a second adhesive material, and the hardness of the first filling material is smaller than that of the second filling material.

6. A method for making a blood window, comprising: placing the sensor in the cavity; An adhesive material is injected into the cavity and a curing operation is performed.

7. The method according to claim 6, wherein the bonding material comprises a first bonding material and a second bonding material, and a curing speed of the first bonding material is greater than a curing speed of the second bonding material; The steps of injecting the adhesive material into the cavity and performing a curing operation include: Adjusting the blood window to a horizontal state where the outer end of the cavity is substantially facing upward; Injecting a first adhesive material into the cavity, and performing a curing operation on the first adhesive material; After the first adhesive material is at least partially cured, injecting a second adhesive material into the cavity and performing a curing operation on the second adhesive material; Preferably, the curing operation of the first adhesive material is performed under the condition that the blood window is substantially in a horizontal state and is subjected to UV light; Preferably, the curing operation of the first adhesive material is performed when the blood window is adjusted to a vertical state or the cavity is located at the upper side and its outer end cavity opening is tilted downward; Preferably, after the first adhesive material is at least partially cured, the blood window is first readjusted to a horizontal state, and then the second adhesive material is injected and subsequently cured; Preferably, before injecting the first adhesive material, a hollow core rod is inserted into the through hole, and the side wall of the core rod is provided with an air hole corresponding to the cavity; during the process of injecting the first adhesive material, a gas for at least partially resisting the effect of gravity is purged into the injected first adhesive material through the air hole; Preferably, the injection amount of the second adhesive material is configured to overflow the outer end cavity opening of the cavity; after the second adhesive material is completely cured to form the second filling material, the portion of the second filling material overflowing outside the outer end cavity opening is polished until the second filling material is flush with the outer surface of the end head; Preferably, the viscosity of the first adhesive material is less than the viscosity of the second adhesive material; and / or, The filling amount of the first adhesive material is less than the filling amount of the second adhesive material; and / or, The thermal conductivity of the first adhesive material is inferior to the thermal conductivity of the second adhesive material; Preferably, the first adhesive material is UV glue, and the second adhesive material is epoxy resin glue.

8. The method according to claim 6, before injecting the bonding material, inserting a hollow core rod into the through hole, wherein the side wall of the core rod is provided with air holes corresponding to the cavity; During the process of injecting the adhesive material, a hot fluid is blown toward the injected adhesive material through the air hole to promote the pre-curing thereof; After the adhesive material is partially cured, the blood window is adjusted to a vertical state or an inclined state, and a secondary curing procedure is performed.

9. The method according to claim 7 or 8, wherein the end head is provided with a guide channel penetrating along the axial direction, and the guide channel is connected with the through hole; Prior to injecting gas / fluid through the gas holes, the channel ports of the guide channels are blocked.

10. A catheter pump, comprising: The blood window according to any one of claims 1 to 5; Or a blood window produced by the method according to any one of claims 6 to 9.

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