Method of manufacturing a detection assembly, detection assembly, and blood pump

Abstract

The application relates to a manufacturing method of a detection assembly, the detection assembly and a blood pump. The detection assembly comprises a sensor and an inner sealing tube, the inner sealing tube is provided with a sensing opening, the sensor comprises a probe and an optical fiber connected with each other, the probe and at least a part connected with the probe are arranged in the inner sealing tube, the inner sealing tube is filled with a first fixing glue and a second fixing glue, the first fixing glue wraps the probe, and part of the first fixing glue forms a conducting wall at the sensing opening, the conducting wall is in contact with the probe, and the second fixing glue wraps at least part of the optical fiber in the inner sealing tube. The manufacturing method of the detection assembly, the detection assembly and the blood pump can seal most of the sensor in the inner sealing tube, so that the sensor is firmly fixed in the inner sealing tube, is not easy to be washed off by blood, and is not easy to jump along the axial direction, and the detection precision of the sensor is ensured.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method for manufacturing a detection component, the detection component, and a blood pump. Background Technology

[0002] Blood pumps assist the heart in pumping blood and are commonly used devices in the adjunctive treatment of cardiovascular diseases. The motor of a blood pump typically contains sensors for detecting blood parameters (such as pressure or flow rate). To prevent contamination of the sensors by blood or perfusion cleaning fluid, the sensors inside the blood pump are usually encapsulated. However, traditional blood pump sensor encapsulation methods are not very robust, and sensors are prone to loosening or even detachment, leading to inaccurate detection. Summary of the Invention

[0003] Therefore, it is necessary to address the issue of poor robustness in the sensor packaging of traditional blood pumps by providing a manufacturing method for the detection component, the detection component, and the blood pump.

[0004] In one embodiment, the manufacturing method of the detection component provided in this application includes the following steps:

[0005] Provide an inner sealing tube with a sensor port;

[0006] The sensor is inserted into the inner sealing tube, such that the sensor probe and at least a portion of the optical fiber connected to the probe are inside the inner sealing tube, and the probe corresponds to the sensing port;

[0007] The inner sealing tube is filled with a first fixing adhesive and a second fixing adhesive; wherein...

[0008] The first fixing adhesive wraps around the probe, and a portion of the first fixing adhesive forms a conductive wall at the sensing port, the conductive wall contacting the probe; the second fixing adhesive wraps around at least a portion of the optical fiber located in the inner sealing tube.

[0009] In one embodiment, the step of providing the inner sealing tube with the sensing port specifically includes the following steps:

[0010] Standard tubing is available;

[0011] The standard tube is stretched along its axial direction to form an adapter tube that is compatible with the sensor;

[0012] A sensing port is provided on the adapter tube to obtain the inner sealing tube.

[0013] In one embodiment, the step of stretching the standard tube along its axial direction to form the adapter tube adapted to the sensor specifically includes the following steps:

[0014] The standard tube is threaded onto the plug gauge, the diameter of which is equal to the outer diameter of the probe;

[0015] The two ends of the standard tube are stretched axially beyond the two ends of the plug gauge;

[0016] The portion of the standard tube extending beyond both ends of the plug gauge is cut off, and the remaining portion of the standard tube is separated from the plug gauge to form the adapter tube.

[0017] In one embodiment, the inner sealing tube has a distal end, a proximal end, and a filling hole; the filling hole is located on the side wall of the inner sealing tube and adjacent to the distal end; the step of filling the interior of the inner sealing tube with a first fixing adhesive and a second fixing adhesive specifically includes:

[0018] The first adhesive is injected into the inner sealing tube from the distal end of the inner sealing tube, and the first adhesive is cured to form the first fixing adhesive.

[0019] The second adhesive is injected into the inner sealing tube through the injection hole, and the second adhesive is cured to form the second fixing adhesive.

[0020] In one embodiment, the first adhesive comprises a first portion of adhesive and a second portion of adhesive; the step of injecting the first adhesive into the inner sealing tube from the distal end of the inner sealing tube and allowing the first adhesive to cure to form the first fixing adhesive specifically includes the following steps:

[0021] Place the inner sealing tube horizontally and pour in the first portion of adhesive from the far end of the inner sealing tube until the first portion of adhesive flows to the adjacent filling hole.

[0022] The first portion of adhesive is solidified to semi-cured inside the inner sealing tube, and the semi-cured first portion of adhesive forms a first inclined surface at the distal tube opening and a first clearance above the first inclined surface.

[0023] Place the inner sealing tube horizontally, pour the second part of the adhesive into the first gap to fill the first gap, and bond it to the first inclined surface.

[0024] Place the inner sealing tube vertically with the distal end facing upwards, so that the liquid level of the second part of the adhesive is flush with the distal end of the inner sealing tube.

[0025] The second portion of adhesive and the semi-cured first portion of adhesive are solidified to form the first fixing adhesive, and the first fixing adhesive at the distal end of the inner sealing tube forms a conductive wall.

[0026] In one embodiment, the specific method for causing the first portion of adhesive to solidify to semi-cured state in the inner sealing tube is as follows: placing the inner sealing tube filled with the first portion of adhesive in an environment with a first temperature T1 and drying it for a first time S1; wherein, 65℃≤T1≤75℃, 1.5h≤S1≤2.5h;

[0027] And / or, the specific method for causing the second portion of adhesive to solidify with the semi-cured first portion of adhesive to a completely solid state is as follows: the inner sealing tube after being filled with the second portion of adhesive is placed in an environment with a second temperature T2 and dried for a second time S2, wherein 65℃≤T2≤75℃ and S2>S1.

[0028] In one embodiment, after performing the step of injecting a first adhesive into the inner sealing tube from the distal end of the inner sealing tube and allowing the first adhesive to cure to form the first fixing adhesive, a second inclined surface is formed at the end of the first fixing adhesive away from the distal end of the tube. The second inclined surface is located inside the injection hole and can guide the second adhesive to flow toward the proximal end of the tube and bond with the second fixing adhesive formed after the second adhesive has cured.

[0029] In one embodiment, the shortest distance from the second inclined surface to the distal end of the inner sealing tube is L1, and the minimum distance from the edge of the glue-filling hole to the distal end of the inner sealing tube is L. 2min The maximum distance from the edge of the glue-filling hole to the distal end of the inner sealing tube is L. 2max , wherein, the L 2min ≤L1<L 2max .

[0030] In one embodiment, after the step of injecting the second fixing adhesive into the inner sealing tube through the injection hole on the side of the inner sealing tube, the method further includes:

[0031] The specific method for curing the second adhesive to form the second fixing adhesive is as follows: the inner sealing tube filled with the second adhesive is placed in an environment with a third temperature T3 and dried for a third time S3; wherein, 65℃≤T3≤75℃, 30min≤S3≤50min.

[0032] In one embodiment, when performing the step of inserting the sensor into the inner sealing tube such that the sensor probe and at least a portion of the optical fiber connected to the probe are inside the inner sealing tube, and the probe corresponds to the sensing port, a preset gap is reserved between the sensor probe and the distal end of the inner sealing tube, so that the first fixing adhesive subsequently filled in can form a conductive wall at the preset gap.

[0033] This application also provides a detection component, the detection component comprising:

[0034] An inner sealing tube, wherein the inner sealing tube is provided with a sensing port;

[0035] The sensor includes a probe and an optical fiber connected to it, the probe and at least a portion of the optical fiber connected to the probe passing through the inner sealing tube; and

[0036] A first fixative and a second fixative are filled inside the inner sealing tube; wherein the first fixative wraps the probe, and a portion of the first fixative forms a conductive wall at the sensing port, the conductive wall contacting the probe; the second fixative wraps at least a portion of the optical fiber located in the inner sealing tube.

[0037] In one embodiment, the inner sealing tube has a distal end and a proximal end; one end of the first fixing adhesive extends to the distal end and is flush with the distal end, and the other end of the first fixing adhesive is connected to the second fixing adhesive; the end of the second fixing adhesive away from the first fixing adhesive extends to the proximal end so as to be flush with the proximal end.

[0038] In one embodiment, the optical fiber includes an inner optical fiber segment located within the inner sealing tube, the inner optical fiber segment including a first sub-segment connected to the probe and a second sub-segment connected to the first sub-segment; wherein, the first fixing adhesive further wraps the first sub-segment and its connection with the probe; the second fixing adhesive wraps the second sub-segment.

[0039] In one embodiment, the inner sealing tube has a distal port and a proximal port, the distal port forming the sensing port; the conductive wall located at the sensing port has a thickness along the axial direction of the inner sealing tube, the thickness being 0.02 mm to 0.05 mm.

[0040] In one embodiment, the inner sealing tube has a filling hole on its side wall for injecting the second fixing adhesive, and the first fixing adhesive has a second inclined surface formed inside the filling hole, the second inclined surface being bonded and fixed to the second fixing adhesive.

[0041] In one embodiment, the first fixing adhesive is a soft gel, and the second fixing adhesive is a hard gel or a soft gel.

[0042] This application also provides a blood pump, the blood pump including a driving device, the driving device comprising:

[0043] An electric motor, the electric motor including a motor housing, the far end of which has a detection port;

[0044] An outer sealing tube, wherein the outer sealing tube is disposed inside the motor housing and fixedly connected to the motor housing, the outer sealing tube having a side opening, the side opening being disposed opposite to the detection port; and

[0045] As described in any of the above embodiments, the detection component is inserted inside the outer sealing tube, the inner sealing tube of the detection component is fixed in the outer sealing tube, and the sensing port of the detection component corresponds to the side opening.

[0046] In one embodiment, the blood pump further includes a cannula assembly and an impeller; the cannula assembly is connected to the distal end of the drive device, and the cannula assembly has a blood inlet and a blood outlet; the impeller is disposed within the cannula assembly and connected to the drive device to be driven to rotate by the drive device.

[0047] The aforementioned detection assembly fills the interior of the inner sealing tube with a first fixing adhesive and a second fixing adhesive. The first fixing adhesive encapsulates the sensor probe, while the second fixing adhesive encapsulates at least a portion of the optical fiber located within the inner sealing tube. This effectively seals most of the sensor within the inner sealing tube, effectively encapsulating the sensor within it using the first and second fixing adhesives. This integrated structure firmly fixes the sensor inside the inner sealing tube, preventing it from easily shifting along its axial direction.

[0048] Furthermore, by forming a conductive wall at the sensing port of the inner sealing tube with a portion of the first fixing adhesive, and with the conductive wall in contact with the probe, blood pressure can be accurately transmitted to the probe through the conductive wall. The conductive wall and the portion of the first fixing adhesive encapsulating the probe form an integral structure, improving the structural stability of the conductive wall and making it less prone to loosening due to blood flow, thus ensuring the sensor's detection accuracy. Therefore, after fixing the detection component of this application into the motor of the blood pump, only the inner sealing tube of the detection component needs to be fixed into the motor to securely encapsulate the sensor within the blood pump, preventing it from easily loosening within the inner sealing tube. Attached Figure Description

[0049] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute an undue limitation of this application.

[0050] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0051] Furthermore, the accompanying drawings are not drawn to a 1:1 scale, and the relative dimensions of the various components are shown as examples only and not necessarily to scale. In the accompanying drawings:

[0052] Figure 1 This is a schematic diagram of the structure of a blood pump according to one embodiment.

[0053] Figure 2 for Figure 1 The blood pump shown is a cross-sectional view under section AA.

[0054] Figure 3 for Figure 2 The image shows a magnified view of part B.

[0055] Figure 4 This is a schematic diagram illustrating the interaction between the detection component and the motor housing in one embodiment.

[0056] Figure 5 This is a schematic diagram of the structure of a detection component according to one embodiment.

[0057] Figure 6 This is a schematic diagram of the structure of a standard tube according to an embodiment.

[0058] Figure 7 This is a schematic diagram of a plug gauge being inserted into a standard tube according to one embodiment.

[0059] Figure 8 This is a schematic diagram of a standard tube being stretched according to one embodiment.

[0060] Figure 9 This is a schematic diagram of a standard tube being cut according to one embodiment.

[0061] Figure 10 This is a schematic diagram of the inner sealing tube in one embodiment.

[0062] Figure 11 This is a schematic diagram of a structure in which a potting hole is opened on the outer side of the inner sealing tube according to one embodiment.

[0063] Figure 12 This is a schematic diagram of a structure in which a sensor is inserted into an inner sealing tube, according to one embodiment.

[0064] Figure 13 This is a schematic diagram of the structure for injecting the first portion of the first fixing adhesive into the inner sealing tube according to an embodiment.

[0065] Figure 14 This is a schematic diagram of a structure for curing the first fixing adhesive of the first part according to an embodiment.

[0066] Figure 15 This is a schematic diagram of the structure for injecting the second part of the first fixing adhesive into the inner sealing tube according to one embodiment.

[0067] Figure 16 This is a schematic diagram of the structure for curing the first fixing adhesive of the second part according to one embodiment.

[0068] Figure 17 This is a schematic diagram of a structure for injecting a second fixing adhesive into an internal sealing tube, according to one embodiment.

[0069] Figure 18 This is a flowchart illustrating a method for manufacturing a detection component according to one embodiment.

[0070] Figure 19 for Figure 18 The flowchart for step S10 shown is shown below.

[0071] Figure 20 for Figure 19 The flowchart for step S12 shown is shown below.

[0072] Figure 21 for Figure 18 The flowchart for step S30 shown is shown below.

[0073] Figure 22 for Figure 21 The flowchart for step S31 shown is shown.

[0074] Explanation of reference numerals in the attached figures:

[0075] 10. Detection component; 11. Sensor; 111. Probe; 112. Fiber optic cable; 1121. First segment; 1122. Second segment; 12. Inner sealing tube; 121. Glue filling hole; 122. Sensing port; 123. Distal port; 124. Proximal port; 12a. Standard tube; 13. First fixing adhesive; 131. Conductive wall; 132. Second inclined surface; 133. First inclined surface; 134. First clearance; 13a. First portion of adhesive; 13b. Second portion of adhesive; 14. Second fixing adhesive; 20. Outer sealing tube; 21. Side opening; 30. Motor; 31. Motor housing; 311. Detection port; 40. Plug gauge; 50. Clamping tool; 60. Glue filling tool; 71. Sleeve assembly; 711. Blood outlet; 72. Impeller. Detailed Implementation

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] It should be noted that in the embodiments of this application, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end closer to the operator during the surgical operation.

[0083] In related technologies, traditional blood pumps have a detection port at the distal end of their motor housing, and a sensor is encapsulated inside the housing, with the distal end of the sensor corresponding to the detection port to detect blood parameters. The conventional method of sensor encapsulation typically involves creating an insertion port at the proximal end of the motor housing, inserting the sensor into a rubber tube, and then inserting the tube containing the sensor into the motor housing through the insertion port. Finally, adhesive is applied to both the detection port and the insertion port to fix the two ends of the sensor to the rubber tube or the motor housing. In other words, this traditional sensor encapsulation method simply fixes the two ends of the sensor to the detection port and the insertion port using adhesive.

[0084] However, the adhesive at the detection port comes into contact with blood flow and is easily washed away and loosened; the adhesive at the insertion port may also loosen due to aging. Once the adhesive at either the detection port or the insertion port loosens, the sensor will become loose. In addition, the diameter of the sensor's optical fiber is usually smaller than the inner diameter of the adhesive tube. After the sensor becomes loose due to the adhesive loosening, it is very easy for the sensor to move along the axial direction of the adhesive tube, resulting in poor sensor encapsulation and inaccurate sensor detection.

[0085] In view of this, see Figures 1 to 3 This application provides a detection component 10, which includes a sensor 11 capable of detecting blood parameters. The detection component 10 can be configured into the motor 30 of a blood pump to detect blood parameters, such as blood pressure or blood flow rate. In this application, the detection component 10 employs a novel packaging method for securing the sensor 11, which reduces the occurrence of sensor 11 loosening, thereby improving the robustness of the sensor packaging and ensuring that the sensor can accurately detect blood parameters.

[0086] See Figure 4 and Figure 5In one embodiment of this application, the detection component 10 includes a sensor 11, an inner sealing tube 12, a first fixing adhesive 13, and a second fixing adhesive 14. The inner sealing tube 12 has a sensing port 122, preferably configured to correspond to the side opening of the outer sealing tube 20. The sensor 11 includes a probe 111 and an optical fiber 112 connected to it. The probe 111 and at least a portion of the optical fiber connected to the probe 111 pass through the inner sealing tube 12. The first fixing adhesive 13 and the second fixing adhesive 14 fill the interior of the inner sealing tube 12. The first fixing adhesive 13 wraps around the probe 111, and a portion of the first fixing adhesive 13 forms a conductive wall 131 at the sensing port 122. The conductive wall 131 contacts the probe 111 to transmit blood pressure to the probe 111. The second fixing adhesive 14 wraps around at least a portion of the optical fiber 112 located within the inner sealing tube 12.

[0087] Specifically, the first fixing adhesive 13 fills the gap between the inner peripheral wall of the inner sealing tube 12 and the probe 111 of the sensor 11, so that the first fixing adhesive 13 both wraps the probe 111 and bonds the probe 111 to the inner peripheral wall of the inner sealing tube 12. A portion of the first fixing adhesive 13 is located at the sensing port 122 to form a conductive wall 131 that contacts the probe 111 at the sensing port 122. In this way, blood flow can enter from the detection port 311 and contact the conductive wall 131 at the sensing port 122. The pressure of the blood flow is transmitted to the probe 111 of the sensor 11 through the conductive wall 131, thus fixing the sensor 11 while ensuring that the sensor 11 can detect blood pressure normally. Similarly, the second fixing adhesive 14 fills the gap between the inner peripheral wall of the inner sealing tube 12 and at least a portion of the optical fiber 112 of the sensor 11, so that the second fixing adhesive 14 both wraps at least a portion of the optical fiber 112 and bonds the at least a portion of the optical fiber 112 to the inner peripheral wall of the inner sealing tube 12. In this way, the probe 112 of the sensor 11 and the small-diameter optical fiber 112 can be firmly fixed in the inner sealing tube 12.

[0088] Therefore, the detection component 10, by filling the inner sealing tube 12 with a first fixing adhesive 13 and a second fixing adhesive 14, with the first fixing adhesive 13 wrapping the probe 111 of the sensor 11 and the second fixing adhesive 14 wrapping at least a portion of the optical fiber 112 located in the inner sealing tube 12, can seal most of the sensor 11 within the inner sealing tube 12. This is equivalent to the sensor 11 being encapsulated within the inner sealing tube 12 by the first fixing adhesive 13 and the second fixing adhesive 14, making the sensor 11 and the inner sealing tube 12 an integrated structure. Thus, the sensor 11 is firmly fixed inside the inner sealing tube 12 and is not easily moved along the axial direction of the inner sealing tube 12.

[0089] Furthermore, by forming a conductive wall 131 at the sensing port 122 of the inner sealing tube 12 with a portion of the first fixing adhesive 13, and the conductive wall 131 contacting the probe 111, blood pressure can be accurately transmitted to the probe 111 through the conductive wall 131. The conductive wall 131 and the portion of the first fixing adhesive 13 encapsulating the probe 111 form an integral structure, improving the structural stability of the conductive wall 131 and making it less prone to loosening due to blood flow, thus ensuring the detection accuracy of the sensor 11. Therefore, after fixing the detection component 10 of this application into the motor of the blood pump, only the inner sealing tube 12 of the detection component 10 needs to be fixed into the motor to securely encapsulate the sensor 11 within the blood pump, preventing easy loosening within the inner sealing tube 12.

[0090] See Figure 5 In one embodiment, the first fixing adhesive 13 is a soft gel. Specifically, the probe 111 of the sensor 11 is a sensitive element. By wrapping the probe 111 with the soft first fixing adhesive 13, the first fixing adhesive 13 can both fix the probe 111 and provide cushioning protection for the probe 111. In addition, the soft first fixing adhesive 13 has good elasticity, so the conductive wall 131 formed by part of the first fixing adhesive 13 is more sensitive to changes in blood pressure, and can more accurately transmit blood pressure to the probe 111, thereby improving the detection accuracy of the sensor 11.

[0091] See Figure 5 In one embodiment, the second adhesive 14 is a rigid adhesive. Specifically, the optical fiber 112 of the sensor 11 is a non-sensitive element. The second adhesive 14 mainly serves to bond and fix the optical fiber 112 to the inner peripheral wall of the inner sealing tube 12 within the inner sealing tube 12. Therefore, configuring the second adhesive 14 as a rigid adhesive makes its adhesion and firmness stronger, and provides higher strength to fix and support the optical fiber 112. Of course, in other embodiments, the second adhesive 14 can also be a soft adhesive, provided that the sensor 11 is not easily loosened.

[0092] It is understood that the soft colloid mentioned in this application refers to the colloid formed after the adhesive solution cures as an elastomer, such as silicone rubber or solvent-based adhesives; the hard colloid refers to the colloid formed after the adhesive solution cures as a rigid, non-elastic body, such as epoxy resin adhesive or structural adhesive. That is, in this application, the first fixing adhesive 13 can be selected as a soft colloid; the second fixing adhesive 14 can be selected as either a hard colloid or a soft colloid.

[0093] See Figure 5In one embodiment, the inner sealing tube 12 has a distal port 123 and a proximal port 124, with the distal port 123 forming a sensing port 122. The optical fiber 112 of the sensor 11 includes an inner optical fiber segment within the inner sealing tube 12 and an outer optical fiber segment extending outward from the proximal port 124 of the inner sealing tube 12. The inner optical fiber segment includes a first sub-segment 1121 connected to the probe 111 and a second sub-segment 1122 connected to the first sub-segment 1121. Optionally, a first fixing adhesive 13 further wraps the first sub-segment 1121 and its connection point with the probe 111; a second fixing adhesive 14 wraps the second sub-segment 1122. Preferably, the probe 111 is welded to the first sub-segment 1121, and a solder joint is formed at the weld between the probe 111 and the first sub-segment 1121, with the first fixing adhesive 13 wrapping the solder joint. Specifically, the probe 111 and the optical fiber 112 are generally fixed by soldering with solder materials such as tin. The solder joint formed by the hot melting of solder materials such as tin is relatively fragile. Therefore, a soft first fixing adhesive 13 is wrapped around the solder joint of the probe 111 and the optical fiber 112. The soft first fixing adhesive 13 can buffer and protect the solder joint, thereby preventing the second fixing adhesive 14 from contacting the solder joint, and thus avoiding the problem of solder joint cracking caused by the second fixing adhesive 14 pressing the solder joint after curing.

[0094] See Figure 5 In one embodiment, the conductive wall 131 located at the sensing port 122 has a thickness h along the axial direction of the inner sealing tube 12. Preferably, the thickness h is 0.02 mm to 0.05 mm. If the conductive wall 131 is too thick, it will hinder pressure transmission; if it is too thin, it will easily loosen or be damaged. By configuring the thickness h to 0.02 mm ≤ h ≤ 0.05 mm, the appropriate thickness of the conductive wall 131 is ensured. The value of the thickness h can be, but is not limited to, 0.02 mm, 0.03 mm, 0.04 mm, or 0.04 mm.

[0095] It is worth noting that in another embodiment, the sensing port 122 can also be opened on the side wall of the inner sealing tube 12. In this case, the conductive wall 131 is formed on the distal side of the inner sealing tube 12, which can also achieve the conduction of blood flow pressure. This will not be elaborated here.

[0096] See Figure 5In one embodiment, one end of the first fixing adhesive 13 extends to the distal end 123 of the inner sealing tube 12 and is flush with the distal end 123; the other end of the first fixing adhesive 13 is connected to the second fixing adhesive 14; the end of the second fixing adhesive 14 away from the first fixing adhesive 13 extends to the proximal end 124 of the inner sealing tube 12 and is flush with the proximal end 124. This arrangement allows the first fixing adhesive 13 and the second fixing adhesive 14 to fill the gaps inside the inner sealing tube 12, thereby wrapping and fixing the portion of the sensor 11 located inside the inner sealing tube 12. This not only improves the reliability of fixing the sensor 11, but also seals the ends of the inner sealing tube 12, effectively improving the sealing performance of the sensor 11.

[0097] See Figure 5 In one embodiment, the inner sealing tube 12 has a filling hole 121 on its side wall for injecting the second fixing adhesive 14. The first fixing adhesive 13 has a second inclined surface 132 formed on the inner side of the filling hole 121, and the second fixing adhesive 14 is bonded and fixed to the second inclined surface 132. Specifically, in one embodiment, when injecting the first fixing adhesive 13 and the second fixing adhesive 14 into the inner sealing tube 12, the first fixing adhesive 13 can be injected first through the distal end port 123 of the inner sealing tube 12, and the second fixing adhesive 14 can be injected through the filling hole 121 after the first fixing adhesive 13 has solidified.

[0098] Since the potting hole 121 is located on the side wall of the inner sealing tube 12, and the first fixing adhesive 13 has a second inclined surface 132 formed inside the potting hole 121, the second inclined surface 132 is inclined relative to the axial direction of the inner sealing tube 12, so that the second inclined surface 132 can guide the adhesive used to form the second fixing adhesive 14 towards the proximal end of the inner sealing tube 12. Thus, when the second fixing adhesive 14 is set, the adhesive used to form the second fixing adhesive 14 can flow from the second inclined surface 132 to the proximal end port 124 of the inner sealing tube 12, so that the air in the inner sealing tube 12 is discharged from the proximal end port 124, avoiding the formation of an air column between the first fixing adhesive 13 and the second fixing adhesive 14, ensuring that the first fixing adhesive 13 and the second fixing adhesive 14 can completely fill the inner sealing tube, and improving the fixing effect of the sensor 11. Meanwhile, the second inclined surface 132 can be bonded and fixed with the cured second fixative 14. Compared with the vertical end face, the second inclined surface 132 has a larger surface area, which can enhance the bonding strength of the first fixative 13 and the second fixative 14.

[0099] See Figures 1 to 3This application also provides a blood pump, which can also be called an interventional blood pump or an interventional ventricular assist device. The blood pump includes a driving device, which includes a motor 30, an outer sealing tube 20, and a detection component 10. The motor 30 includes a motor housing 31, with a detection port 311 at its distal end for blood flow. The outer sealing tube 20 is disposed inside and fixedly connected to the motor housing 31, and has a side opening 21 opposite to the detection port 311. The detection component 10 is used to detect blood flow pressure and is disposed within and fixed in the outer sealing tube 20. The specific structure of the detection component 10 is as described in the above embodiments. Since the blood pump adopts all the technical solutions of all the above embodiments, it possesses at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be elaborated further here.

[0100] When the blood pump equipped with this drive device is inserted into the patient's body, the blood flow F located around the blood pump can enter from the detection port 311 into the side opening 21, and then flow from the side opening 21 to the sensing port 122. At the sensing port 122, it is sensed by the probe 111 of the sensor 11 in the detection assembly 10, allowing the sensor 11 to detect blood pressure. It is understood that, compared to the traditional method of directly inserting the sensor 11 into the outer sealing tube 20, the blood pump of this application first encapsulates the sensor 11 into the inner sealing tube 11 using the first fixing adhesive 13 and the second fixing adhesive 14, integrating it into a single structure. Then, the sensor 11 is inserted into the outer sealing tube 20 through the inner sealing tube 11, and fixed by the cooperation between the inner sealing tube 11 and the outer sealing tube 20, achieving a dual-tube encapsulation of the sensor 11. This further improves the robustness and sealing of the sensor 11 encapsulation.

[0101] Specifically, the inner sealing tube 11 is shorter than the outer sealing tube 20 and is installed at the far end of the outer sealing tube 20. Optionally, with the outer sealing tube 20 fixed to the motor housing 31, the inner sealing tube 11 can be configured to have an interference fit with the outer sealing tube 20, resulting in a larger contact area between the outer peripheral wall of the inner sealing tube 11 and the inner peripheral wall of the outer sealing tube 20, making it less likely for the inner sealing tube 11 to move within the outer sealing tube 20. Alternatively, a sealing structure (such as a sealing cap or sealant) can be provided at both ends of the outer sealing tube 20 to confine the inner sealing tube 11 within the outer sealing tube 20. This configuration further improves the robustness and sealing of the sensor 11 installation.

[0102] In one embodiment, the blood pump is adapted to be inserted into the patient's ventricle via a blood vessel to assist the ventricle in pumping blood into the blood vessels. The blood pump may further include a cannula assembly 71 and an impeller 72. The cannula assembly 71 is connected to the distal end of a drive device and has a blood outlet 711 and a blood inlet (not shown in the figure). The impeller 72 is disposed within the cannula assembly 71 and connected to the drive device. The impeller 72 can be driven to rotate by the drive device, thereby realizing the pumping of blood. Taking the blood pump's intervention in the left ventricle as an example, when the blood pump is inserted into the patient's body, the blood inlet of the blood pump is located within the left ventricle, and the blood outlet 711 of the blood pump is located within the aorta, so as to pump blood from the left ventricle into the aorta.

[0103] This application also provides a method for manufacturing a detection component, used to fabricate the detection component 10 of any of the above embodiments. Specifically, see... Figure 18 A method for manufacturing a detection component according to an embodiment of this application includes the following steps:

[0104] S10: Provide an inner sealing tube 12 with a sensing port 122.

[0105] S20: Insert the sensor 11 into the inner sealing tube 12, so that the probe 111 of the sensor 11 and at least part of the optical fiber 112 connected to the probe 111 are inside the inner sealing tube 12, and the probe 111 corresponds to the sensing port 122.

[0106] S30: Fill the interior of the inner sealing tube 12 with a first fixing adhesive 13 and a second fixing adhesive 14; wherein, the first fixing adhesive 13 wraps the probe 111 of the sensor 11, and a portion of the first fixing adhesive 13 forms a conductive wall 131 at the sensing port 122 that contacts the probe 111; the second fixing adhesive 14 wraps at least a portion of the optical fiber 112 located in the inner sealing tube 12.

[0107] Specifically, sensor 11 includes a probe 111 and an optical fiber 112 connected to the probe 111. The outer diameter of probe 111 is typically larger than the outer diameter of optical fiber 112. Therefore, in step S10, the inner diameter of inner sealing tube 12 should not be smaller than the outer diameter of probe 111 of sensor 11, ensuring that sensor 11 can be inserted into the interior of inner sealing tube 12. In step S20, after sensor 11 is inserted into the interior of inner sealing tube 12, the gap between the outer peripheral surface of optical fiber 112 and the inner peripheral wall of inner sealing tube 12 will be larger than the gap between the outer peripheral surface of probe 111 and the inner peripheral wall of inner sealing tube 12, making optical fiber 112 more mobile and able to pull on probe 111. Therefore, in step S30, the present application fills the interior of the inner sealing tube 12 with a first fixing adhesive 13 and a second fixing adhesive 14, so that the first fixing adhesive 13 wraps the probe 111 of the sensor 11, and the second fixing adhesive 14 wraps at least part of the optical fiber 112 located in the inner sealing tube 12. Not only can the probe 111 of the sensor 11 be fixed in the inner sealing tube 12, but the optical fiber 112 of the sensor 11 can also be glued and fixed in the inner sealing tube 12.

[0108] The aforementioned detection component 10 fills the interior of the inner sealing tube 12 with a first fixing adhesive 13 and a second fixing adhesive 14, such that the first fixing adhesive 13 wraps around the probe 111 of the sensor 11, and the second fixing adhesive 14 wraps around at least a portion of the optical fiber 112 located within the inner sealing tube 12. This encapsulates most of the sensor 11 within the inner sealing tube 12, effectively encapsulating the sensor 11 within the inner sealing tube 12 using the first fixing adhesive 13 and the second fixing adhesive 14. This integrates the sensor 11 and the inner sealing tube 12 into a single structure, firmly fixing the sensor 11 inside the inner sealing tube 12 and preventing it from easily shifting along the axial direction of the inner sealing tube 12.

[0109] Furthermore, by forming a conductive wall 131 at the sensing port 122 of the inner sealing tube 12 with a portion of the first fixing adhesive 13, and the conductive wall 131 contacting the probe 111, blood pressure can be accurately transmitted to the probe 111 through the conductive wall 131. The conductive wall 131 and the portion of the first fixing adhesive 13 encasing the probe 111 form an integral structure, improving the structural stability of the conductive wall 131 and making it less prone to loosening due to blood flow, thus ensuring the detection accuracy of the sensor 11. Therefore, after fixing the detection component 10 of this application into the motor of the blood pump, it is only necessary to fix the inner sealing tube 12 of the detection component 10 in conjunction with the motor to securely encapsulate the sensor 11 within the blood pump, preventing easy loosening within the inner sealing tube 12.

[0110] Considering that the inner sealing tube 12 used in traditional blood pumps is mostly a standard tube 12a directly purchased from the market or mass-produced, the inner or outer diameter of the standard tube 12a inevitably has certain manufacturing errors. This may result in mismatch issues such as the inner diameter of the standard tube 12a being smaller than the outer diameter of the probe 111 of the sensor 11, or the outer diameter of the standard tube 12a being larger than the inner diameter of the outer sealing tube 20. Based on this, see... Figure 19 In one embodiment, step S10 specifically includes the following steps:

[0111] S11: Standard tube 12a is provided.

[0112] Specifically, the standard tube 12a can be a standard part purchased from the market or mass-produced, with dimensions not significantly different from the sensor 11. See also Figure 6 Assume the initial inner diameter of standard tube 12a is D1, the initial outer diameter is D2, and the initial length is M. Preferably, standard tube 12a is a rubber tube, such as a PI tube, to give it a certain degree of ductility. The PI tube refers to a tube made of polyimide or polyamide material.

[0113] S12: The standard tube 12a is stretched along its axial direction to form an adapter tube 12b that is adapted to the sensor 11.

[0114] In this way, the cavity structure of the adapter tube 12b is adapted to the size (e.g., radial dimension) and / or shape (e.g., outer contour) of the sensor 11, ensuring that the sensor 11 can be inserted into the interior of the adapter tube 12b.

[0115] Specifically, by stretching the standard tube 12a along its axial direction, the inner and outer diameters of the standard tube 12a can be adjusted so that the inner diameter of the adapter tube 12b formed by stretching the standard tube 12a can be adapted to the probe 111 of the sensor 11, thereby ensuring that the standard tube 12a can be inserted into the probe 111 of the sensor 11; preferably, the outer diameter of the adapter tube 12b can also be adapted to the inner diameter of the outer sealing tube 20, so that the adapter tube 12b can be inserted into the outer sealing tube 20.

[0116] S13: A sensing port 122 is provided on the adapter tube 12b to obtain the inner sealing tube 12.

[0117] Specifically, in one embodiment, the sensing port 122 may be formed on the side wall of the inner sealing tube 12. Preferably, see... Figure 10 The sensing port 122 can also be formed directly from one end of the inner sealing tube 12, thus eliminating step S13.

[0118] See Figure 20 In one embodiment, step S12 specifically includes the following steps:

[0119] S121: Insert the standard tube 12a onto the plug gauge 40; the diameter of the plug gauge 40 is equal to the outer diameter of the probe 111.

[0120] Specifically, see Figure 7 The plug gauge 40 is a cylindrical structure, and its diameter is equal to the outer diameter of the probe 111. Preferably, the length of the plug gauge 40 is longer than the initial length M of the standard tube 12a, so that both ends of the plug gauge 40 can extend out of the two ends of the standard tube 12a respectively. Of course, in critical cases, the length of the plug gauge 40 can also be equal to the initial length M of the standard tube 12a.

[0121] S122: Stretch both ends of the standard tube 12a axially beyond the ends of the plug gauge 40;

[0122] Specifically, see Figure 8 The standard tube 12a can be stretched and extended along its axis by clamping the two ends of the standard tube 12a with two clamping tools 50 respectively and moving the two clamping tools 50 in opposite directions. In this way, the inner diameter of the standard tube 12a is expanded to be equal to the diameter of the plug gauge 40, and the outer diameter of the standard tube 12a is reduced due to stretching, ensuring that the inner and outer diameters of the standard tube 12a meet the usage requirements.

[0123] S123: The portion of the standard tube 12a that extends beyond both ends of the plug gauge 40 is cut off, and the remaining portion of the standard tube 12a is separated from the plug gauge 40 to form the adapter tube 12b.

[0124] Specifically, see Figure 9 The length of the adapter tube 12b is equal to the length of the plug gauge 40, thus controlling the length of the plug gauge 40 ensures that the length of the adapter tube 12b meets the usage requirements. Specifically, in conjunction with... Figure 10 The adapter tube 12b is obtained by stretching and cutting the standard tube 12a. The inner diameter d1 of the adapter tube 12b is expanded relative to the inner diameter D1 of the standard tube 12a, that is, d1 > D1; the outer diameter d2 of the adapter tube 12b is reduced relative to the outer diameter D2 of the standard tube 12a, that is, d2 < D2; the length m of the adapter tube 12b is unchanged or extended relative to the length M of the standard tube 12a, that is, m ≥ M. Thus, the standard tube 12a is transformed into an adapter tube 12b that is compatible with the sensor 11.

[0125] Specifically, see Figure 11 as well as Figure 12 The inner sealing tube 12 has a distal port 123, a proximal port 124, and a filling hole 121; the filling hole 121 is located on the side wall of the inner sealing tube 12 and is adjacent to the distal port 123. See also Figure 21 Step S30 specifically includes the following steps:

[0126] S31: The first adhesive liquid is injected into the inner sealing tube 12 from the distal end port 123 of the inner sealing tube 12, and the first adhesive liquid is cured to form the first fixing adhesive 13.

[0127] S32: The second adhesive is injected into the inner sealing tube 12 through the injection hole 121, and the second adhesive is cured to form the second fixing adhesive 14.

[0128] Specifically, since the first fixing adhesive 13 is used to wrap and fix the probe 111 of the sensor 11, the first adhesive liquid is first poured into the inner sealing tube 12 in step S31 to form the first fixing adhesive 13. Because the optical fiber 112 of the sensor 11 has not yet been fixed at this time, the probe 111 of the sensor 11 can be adjusted in time during the pouring of the first adhesive liquid, so that the probe 111 is precisely aligned with the sensing port of the inner sealing tube 12. After step S31, the position of the probe 111 has been precisely fixed by the first fixing adhesive 13 and will not easily shift. Thus, when the second adhesive liquid is poured into the inner sealing tube 12 in the subsequent execution of step S32, the probe 111 will not easily shift due to the operation of pouring the second adhesive liquid into the inner sealing tube 12.

[0129] In one embodiment, the distal end 123 of the inner sealing tube 12 is used as the sensing port 122 of the inner sealing tube 12. The first fixing adhesive 13 is flush with the distal end 123 of the inner sealing tube 12, such that the portion of the first fixing adhesive 13 at the distal end 123 forms a conductive wall 131. Specifically, see Figure 12 When performing step S20, a preset interval h is maintained between the distal end of the probe 111 of the sensor 11 and the distal end of the inner sealing tube 123, so that the first fixing adhesive 13 that is subsequently filled can form a conductive wall 131 at the preset interval h.

[0130] Generally, the conductive wall 131 is relatively flat, which can improve the accuracy of transmitting blood pressure from the conductive wall 131 to the probe 111. However, the study found that when the first adhesive is injected, the first adhesive is easily affected by gravity and flows downwards. This causes the first fixing adhesive 13 formed after the first adhesive has solidified to be uneven with the distal end 123 of the inner sealing tube 12. In other words, the conductive wall 131 is not flush, which can easily affect the detection accuracy of the sensor 11.

[0131] Therefore, to ensure that the first adhesive, after curing, is flush with the distal opening 123 of the inner sealing tube 12, optionally, the first adhesive is injected in two stages during step S31. Specifically, the first adhesive includes a first portion of adhesive and a second portion of adhesive, see [link to relevant documentation]. Figure 22 Step S31 includes steps S311 to S315; wherein:

[0132] S311: See also Figure 13Place the inner sealing tube 12 horizontally and pour the first part of the adhesive 13a into the far end of the inner sealing tube 12 through the tube opening 123 until the first part of the adhesive 13a flows to the adjacent filling hole 121.

[0133] Specifically, before injecting the first portion of adhesive 13a, an injection hole 121 can be made on the side of the inner sealing tube 12. The injection hole 121 is located on the side wall between the proximal end opening 124 of the inner sealing tube 12 and the probe 111. The injection hole 121 can be used to inject the second portion of adhesive, and it also facilitates observation of the spread of the first portion of adhesive 13a in the inner sealing tube 12. When the first portion of adhesive 13a flows from the distal end opening 123 of the inner sealing tube 12 to its proximal end and reaches the adjacent injection hole 121, it can be determined that the first portion of adhesive 13a has wrapped around the probe 111. When performing step S311, the inner sealing tube 12 is placed horizontally under a microscope. Then, the first part of the adhesive 13a is injected from the distal end of the inner sealing tube 123 using the glue-pouring tool 60. At the same time, the glue-pouring hole 121 is observed in real time through the microscope. When the first part of the adhesive 13a is observed from the glue-pouring hole 121, it means that the first part of the adhesive 13a has passed through the gap around the probe 111 from the distal end of the inner sealing tube 123 and reached the proximal end of the probe 111. That is, the first part of the adhesive 13a has wrapped around the probe 111. At this time, the injection can be stopped to prevent the first part of the adhesive from overflowing from the distal end of the inner sealing tube 123.

[0134] S312: The first portion of adhesive 13a is solidified to semi-cured in the inner sealing tube 12. The semi-cured first portion of adhesive 13a forms a first inclined surface 133 at the distal tube opening 123 and a first clearance 134 above the first inclined surface 133.

[0135] Specifically, since the inner sealing tube 12 is placed horizontally during step S311, when the first portion of adhesive 13a is injected, the first portion of adhesive 13a is affected by gravity, and one end of the first portion of adhesive 13a will spread outward towards the distal opening 123, that is, towards... Figure 13 The adhesive spreads diagonally downwards to the left of the viewing angle shown, and will not completely fill the distal end of the tube opening 123; the other end of the first portion of adhesive 13a will spread towards the inside of the dispensing hole 121, that is, towards... Figure 13The adhesive spreads downwards and to the right from the shown perspective, resulting in bevels at both ends of the first portion of adhesive 13a. Therefore, after step S312, the distal end of the semi-cured first portion of adhesive 13a cannot be filled to be flush with the distal opening 123 of the inner sealing tube 12. Instead, a first bevel 133 and a first gap 134 above the first bevel 133 are formed at the distal opening 123 of the inner sealing tube 12. A second bevel 132 is formed at the proximal end of the semi-cured first portion of adhesive 13a. Since the first portion of adhesive 13a is in a semi-cured state at this time, the first bevel 133 still has a certain degree of tackiness to facilitate adhesion to the subsequent second portion of adhesive 13b.

[0136] S313: See also Figure 15 The inner sealing tube 12 is placed horizontally, and the second portion of adhesive 13b is poured into the first gap 134 to fill the first gap 134 and bond it to the first inclined surface 133. At this time, the second portion of adhesive 13b is liquid, while the first portion of adhesive 13a is semi-cured, which makes the first inclined surface 133 also have a certain degree of viscosity. Therefore, after the liquid second portion of adhesive 13b comes into contact with the first inclined surface 133 of the semi-cured first portion of adhesive 13a, they can bond together to form a whole, with stronger adhesion and avoiding delamination.

[0137] S314: See also Figure 16 The inner sealing tube 12 is placed upright with its distal end facing upwards, so that the liquid level of the second part of adhesive 13b is flush with the distal end opening 123 of the inner sealing tube 12. Since the amount of adhesive in the second part of adhesive 13b is less than that in the first part of adhesive 13a, when step S314 is performed, the inner sealing tube 12 is quickly erected with its distal end facing upwards before the second part of adhesive 13b has spread out, so that the second part of adhesive 13b fills the first gap 134, and the liquid level of the second part of adhesive 13b is flush with the distal end opening 123 of the inner sealing tube 12 under the action of gravity.

[0138] S315: The second portion of adhesive 13b and the semi-cured first portion of adhesive 13a are solidified to form a first fixing adhesive 13. The first fixing adhesive 13 at the distal end 123 of the inner sealing tube 12 forms a conductive wall 131. Since the liquid surface of the second portion of adhesive 13b is flush with the distal end 123 of the inner sealing tube 12 under the action of gravity in step S314, the conductive wall 131 formed by the portion of the first fixing adhesive 13 filling the distal end 123 is a flat wall surface flush with the distal end 123. This allows for more accurate transmission of blood pressure to the probe 111 of the sensor 11, thereby improving the detection accuracy of the sensor 11.

[0139] In the aforementioned step S312, since the first part of the adhesive 13a needs to be dried to a semi-cured state, the ambient temperature and drying time are subject to strict requirements. The ambient temperature should not be too high, and the drying time should not be too long, otherwise the first part of the adhesive 13a may quickly and completely cure. Therefore, experimental studies were conducted with the ambient temperature and drying time as variables to obtain parameter data of the curing state of the first part of the adhesive 13a under different experimental conditions. The study of these parameter data showed that the optimal working conditions for the semi-curing of the first part of the adhesive 13a are an ambient temperature of 65℃~75℃ and a drying time of 1.5h~2.5h.

[0140] Based on this, in one embodiment, when performing step S312, the specific method for solidifying the first portion of adhesive 13a to a semi-cured state within the inner sealing tube 12 is as follows: the inner sealing tube 12 filled with the first portion of adhesive 13a is placed in an environment with a first temperature T1 and dried for a first time S1; wherein, 65℃≤T1≤75℃, 1.5h≤S1≤2.5h. Under these conditions, the semi-cured state of the first portion of adhesive 13a is better. Specifically, the value of T1 can be, but is not limited to, 65℃, 68℃, 70℃, 73℃, etc. The value of S1 can be, but is not limited to, 1.7h, 2.0h, 2.2h, 2.4h, etc.

[0141] In one embodiment, optionally, during step S315, the specific method for solidifying the second portion of adhesive 13b and the semi-cured first portion of adhesive 13a to form the first fixing adhesive 13 is as follows: the inner sealing tube 12, after being filled with the second portion of adhesive 13b, is placed vertically in an environment with a second temperature T2 and dried for a second time S2 to completely solidify the second portion of adhesive 13b and the semi-cured first portion of adhesive 13a, so that the first portion of adhesive 13a and the second portion of adhesive 13b form an integral first fixing adhesive 13, wherein 65℃≤T2≤75℃, and S2>S1. It should be noted that the second temperature T2 can be equal to the first temperature T1; the second time S2 should be longer than the first time S1 to ensure that both the first portion of adhesive 13a and the second portion of adhesive 13b can be completely cured, and the first fixing adhesive 13 formed after complete curing has better elasticity. Optionally, 5h≤S2≤7h. Specifically, the value of T2 can be, but is not limited to, 66℃, 68℃, 70℃, 74℃, etc. The value of S2 can be, but is not limited to, 1.7h, 2.0h, 2.2h, 2.4h, etc.

[0142] See Figure 21Because the second fixing adhesive 14 is a hard colloid, the curing conditions for the second adhesive are different from those for the first adhesive, which is cured in two stages. The drying temperature of the second adhesive should not be too low, and the drying time should not be too short, otherwise incomplete curing may occur. Therefore, experiments were conducted using the drying temperature and drying time as variables to obtain parameter data on the curing state of the second adhesive under different experimental conditions. Analysis of these parameter data revealed that the optimal curing conditions for the second adhesive are an ambient temperature of 65℃~75℃ and a drying time of 30min~50min.

[0143] Based on this, in one embodiment, during the execution of step S32, the specific method for curing the second adhesive to form the second fixing adhesive 14 is as follows: the inner sealing tube 12 filled with the second adhesive is placed in an environment with a third temperature T3 and dried for a third time S3; wherein, 65℃≤T3≤75℃, 30min≤S3≤50min. Under these conditions, the second adhesive can be completely cured into the second fixing adhesive 14, and the second fixing adhesive 14 has strong strength, thus improving the firmness of the second fixing adhesive 14 in fixing the optical fiber 112. Specifically, the value of T3 can be, but is not limited to, 65℃, 68℃, 70℃, 74℃, etc. The value of S3 can be, but is not limited to, 30min, 35minh, 40min, 50min, etc.

[0144] Further, see Figure 17 After step S312 is executed, a second inclined surface 132 is formed at the end of the first fixing adhesive 13 away from the distal end port 123. The second inclined surface 132 is located inside the glue-filling hole 121. When step S32 is executed in the subsequent step, the second inclined surface 133 can guide the second adhesive liquid to flow toward the proximal end port 124 and bond with the second fixing adhesive 14 formed after the second adhesive liquid is cured, so that the first fixing adhesive 13 and the second fixing adhesive 14 are bonded together.

[0145] Specifically, the second inclined surface 132 is axially inclined relative to the inner sealing tube 12, so that during the subsequent execution of step S32, the second adhesive can be guided by the second inclined surface 132 to flow towards the proximal end port 124 of the inner sealing tube 12, thereby forcing the air in the inner sealing tube 12 to be discharged from the proximal end port 124, avoiding the formation of an air column between the first fixing adhesive 13 and the second fixing adhesive 14, and ensuring that the first fixing adhesive 13 and the second fixing adhesive 14 together fill the inner sealing tube 12. At the same time, the second inclined surface 132 can bond and fix with the second fixing adhesive 14 formed by the cured second adhesive. Compared with the vertical end face, the second inclined surface 132 has a larger surface area, which can enhance the bonding strength of the first fixing adhesive 13 and the second fixing adhesive 14.

[0146] Further, see Figure 14The shortest distance from the second inclined surface 132 to the distal end of the inner sealing tube 123 is L1, and the minimum distance from the edge of the glue-filling hole 121 to the distal end of the inner sealing tube 123 is L. 2min The maximum distance from the edge of the glue-filling hole 121 to the distal end of the inner sealing tube 123 is L. 2max L 2min ≤L1<L 2max That is, the end of the second inclined surface 132 closest to the far end of the inner sealing tube 12, the far end of the tube 123, is located on the side wall of the glue-filling hole 121, thereby completely avoiding the presence of air between the first fixing glue 13 and the second fixing glue 14, and improving the anti-air column effect.

[0147] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered within the scope of this specification. The embodiments described above only illustrate several implementation methods of this application, and their descriptions are relatively specific and detailed, but 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 several 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 method for manufacturing a detection component, characterized in that, Includes the following steps: An inner sealing tube with a sensing port is provided, wherein the distal end of the inner sealing tube serves as the sensing port. The sensor is inserted into the inner sealing tube, such that the sensor probe and at least a portion of the optical fiber connected to the probe are inside the inner sealing tube, and the probe corresponds to the sensing port; The inner sealing tube is filled with a first fixing adhesive and a second fixing adhesive; the first fixing adhesive wraps around the probe, and a portion of the first fixing adhesive forms a conductive wall at the sensing port, the conductive wall contacting the probe; the second fixing adhesive wraps around at least a portion of the optical fiber located in the inner sealing tube. The step of filling the interior of the inner sealing tube with a first fixing adhesive and a second fixing adhesive specifically includes: The first adhesive is injected into the inner sealing tube from the distal end of the inner sealing tube, and the first adhesive is cured to form the first fixing adhesive. A second inclined surface is formed at the end of the first fixing adhesive away from the distal end of the tube. An adhesive injection hole is formed on the side wall of the inner sealing tube. The second inclined surface is located inside the adhesive injection hole and is inclined relative to the axial direction of the inner sealing tube. The second adhesive is injected into the inner sealing tube through the injection hole, and the second adhesive flows along the second inclined surface toward the proximal end of the inner sealing tube, so that the second adhesive cures to form the second fixing adhesive, which is then bonded and fixed to the second inclined surface.

2. The method for manufacturing the detection component according to claim 1, characterized in that, The step of providing the inner sealing tube with the sensing port specifically includes the following steps: Standard tubing is available; The standard tube is stretched along its axial direction to form an adapter tube that is compatible with the sensor; A sensing port is provided on the adapter tube to obtain the inner sealing tube.

3. The method for manufacturing the detection component according to claim 2, characterized in that, The step of stretching the standard tube along its axial direction to form an adapter tube adapted to the sensor specifically includes the following steps: The standard tube is threaded onto the plug gauge, the diameter of which is equal to the outer diameter of the probe; The two ends of the standard tube are stretched axially beyond the two ends of the plug gauge; The portion of the standard tube extending beyond both ends of the plug gauge is cut off, and the remaining portion of the standard tube is separated from the plug gauge to form the adapter tube.

4. The method for manufacturing the detection component according to claim 1, characterized in that, The first fixing adhesive is flush with the distal end of the inner sealing tube, so that the portion of the first fixing adhesive at the distal end forms the conductive wall.

5. The method for manufacturing the detection component according to claim 1, characterized in that, The first adhesive comprises a first portion of adhesive and a second portion of adhesive; the step of injecting the first adhesive into the inner sealing tube from the distal end of the inner sealing tube and allowing the first adhesive to cure to form the first fixing adhesive specifically includes the following steps: Place the inner sealing tube horizontally and pour in the first portion of adhesive from the far end of the inner sealing tube until the first portion of adhesive flows to the adjacent filling hole. The first portion of adhesive is solidified to semi-cured inside the inner sealing tube, and the semi-cured first portion of adhesive forms a first inclined surface at the distal tube opening and a first clearance above the first inclined surface. Place the inner sealing tube horizontally, pour the second part of the adhesive into the first gap to fill the first gap, and bond it to the first inclined surface. Place the inner sealing tube vertically with the distal end facing upwards, so that the liquid level of the second part of the adhesive is flush with the distal end of the inner sealing tube. The second portion of adhesive and the semi-cured first portion of adhesive are solidified to form the first fixing adhesive, and the first fixing adhesive at the distal end of the inner sealing tube forms a conductive wall.

6. The method for manufacturing the detection component according to claim 5, characterized in that: The specific method for solidifying the first portion of adhesive solution into a semi-cured state within the inner sealing tube is as follows: placing the inner sealing tube filled with the first portion of adhesive solution in an environment with a first temperature T1 and drying it for a first time S1; wherein, 65℃≤T1≤75℃, 1.5h≤S1≤2.5h; And / or, the specific method for causing the second portion of adhesive to solidify with the semi-cured first portion of adhesive to a completely solid state is as follows: the inner sealing tube after being filled with the second portion of adhesive is placed in an environment with a second temperature T2 and dried for a second time S2, wherein 65℃≤T2≤75℃ and S2>S1.

7. The method for manufacturing the detection component according to claim 1, characterized in that, The end of the second inclined plane closest to the distal end of the inner sealing tube is located on the side wall of the glue-filling hole.

8. The method for manufacturing the detection component according to claim 1, characterized in that, Let L1 be the shortest distance from the second inclined surface to the distal end of the inner sealing tube, and let L be the minimum distance from the edge of the glue-filling hole to the distal end of the inner sealing tube. 2min The maximum distance from the edge of the glue-filling hole to the distal end of the inner sealing tube is L. 2max , wherein, the L 2min ≤L1<L 2max .

9. The method for manufacturing the detection component according to claim 1, characterized in that, The specific method for curing the second adhesive to form the second fixing adhesive is as follows: the inner sealing tube filled with the second adhesive is placed in an environment with a third temperature T3 and dried for a third time S3; wherein, 65℃≤T3≤75℃, 30min≤S3≤50min.

10. A method for manufacturing a detection component according to any one of claims 1 to 9, characterized in that, When performing the step of inserting the sensor into the inner sealing tube, such that the sensor probe and at least a portion of the optical fiber connected to the probe are inside the inner sealing tube, and the probe corresponds to the sensing port, a preset gap is reserved between the sensor probe and the distal end of the inner sealing tube, so that the first fixing adhesive subsequently filled can form the conductive wall at the preset gap.

11. A detection component, characterized in that, The detection component includes: An inner sealing tube, wherein the inner sealing tube is provided with a sensing port; The sensor includes a probe connected to it and an optical fiber, the probe and at least a portion of the optical fiber connected to the probe passing through the inner sealing tube; and A first fixative and a second fixative are filled inside the inner sealing tube; wherein, the first fixative wraps the probe, and a portion of the first fixative forms a conductive wall at the sensing port, the conductive wall contacting the probe; the second fixative wraps at least a portion of the optical fiber located in the inner sealing tube. The inner sealing tube has a distal end port, a proximal end port, and a filling hole; the distal end port serves as the sensing port, the filling hole is located on the side wall of the inner sealing tube and adjacent to the distal end port, the first fixing adhesive forms a second inclined surface on the inner side of the filling hole, the second inclined surface is inclined relative to the axial direction of the inner sealing tube, the second inclined surface is used to guide the second adhesive liquid forming the second fixing adhesive to flow towards the proximal end port of the inner sealing tube, and the second inclined surface is bonded and fixed to the second fixing adhesive.

12. The detection component according to claim 11, characterized in that, One end of the first fixing adhesive extends to the distal end of the tube and is flush with the distal end of the tube; the other end of the first fixing adhesive is connected to the second fixing adhesive; the end of the second fixing adhesive away from the first fixing adhesive extends to the proximal end of the tube and is flush with the proximal end of the tube.

13. The detection component according to claim 11, characterized in that, The optical fiber includes an inner optical fiber segment located within the inner sealing tube. The inner optical fiber segment includes a first sub-segment connected to the probe and a second sub-segment connected to the first sub-segment. The first fixing adhesive also wraps the first sub-segment and its connection with the probe. The second fixing adhesive wraps the second sub-segment.

14. The detection component according to claim 11, characterized in that, The conductive wall located at the sensing port has a thickness along the axial direction of the inner sealing tube, the thickness being 0.02 mm to 0.05 mm.

15. The detection component according to claim 11, characterized in that, The end of the second inclined plane closest to the distal end of the inner sealing tube is located on the side wall of the glue-filling hole.

16. The detection component according to any one of claims 11 to 15, characterized in that, The first fixing adhesive is a soft gel, and the second fixing adhesive is a hard gel or a soft gel.

17. A blood pump, characterized in that, The blood pump includes a drive unit, the drive unit comprising: An electric motor, the electric motor including a motor housing, the far end of which has a detection port; An outer sealing tube, wherein the outer sealing tube is disposed inside the motor housing and fixedly connected to the motor housing, the outer sealing tube having a side opening, the side opening being disposed opposite to the detection port; and The detection component as described in any one of claims 11 to 16, wherein the detection component is disposed within the outer sealing tube, the inner sealing tube of the detection component is fixed within the outer sealing tube, and the sensing port of the detection component corresponds to the side opening.

18. The blood pump according to claim 17, characterized in that, The blood pump also includes: A cannula assembly, connected to the distal end of the drive device, the cannula assembly having a blood inlet and a blood outlet; and An impeller is disposed within the sleeve assembly and connected to the drive device for rotation by the drive device.

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