Drive device and blood pump
Patent Information
- Application Number
- CN202311357284.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2023-10-19
- Publication Date
- 2026-09-04
- Estimated Expiration
- 2043-10-19
AI Technical Summary
[0004]基于此,有必要针对传统的血泵中,传感器封装稳定性差,影响检测精度的问题,提供一种驱动装置及血泵
[0020] In the aforementioned drive device, by encapsulating the sensor probe and part of the optical fiber within an inner sealing tube, the sensor of the detection component and the inner sealing tube are integrated into a single structure. This ensures the sensor is firmly fixed inside the inner sealing tube, preventing axial movement along the inner sealing tube. Furthermore, the inner sealing tube of the detection component is then fixed within an outer sealing tube, and finally, the outer sealing tube is fixed inside the motor housing. This effectively encapsulates the sensor within a double-tube structure composed of the inner and outer sealing tubes. Compared to traditional single-tube sensor encapsulation methods, this application, by first encapsulating the sensor within the inner sealing tube and then fixing it to the inside of the outer sealing tube, provides a larger mating surface between the outer and inner walls of the inner and outer sealing tubes. This results in a more stable assembly, preventing the inner sealing tube from moving axially along the outer sealing tube, further enhancing the sensor's encapsulation robustness and preventing axial movement.
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Figure CN117504116B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to drive devices and blood pumps. Background Technology
[0002] Blood pumps typically incorporate sensors within their drive unit to detect blood pressure. To prevent contamination of the sensor by blood or perfusion cleaning fluid, it is usually encapsulated.
[0003] In related technologies, a sensor within a drive unit is housed in a tubing and extends through the tubing into the motor housing of the drive unit. The proximal end of the sensor is fixed to the tubing with rigid adhesive, while the distal end is fixed to both the tubing and the motor housing with flexible adhesive. However, the flexible adhesive at the distal end of the sensor is easily washed away by blood and becomes detached. Furthermore, because the sensor diameter is smaller than the inner diameter of the tubing, once the flexible adhesive at the distal end becomes detached, the sensor is highly susceptible to axial movement along the tubing, leading to inaccurate detection. Summary of the Invention
[0004] Therefore, it is necessary to provide a driving device and a blood pump to address the problem of poor sensor packaging stability in traditional blood pumps, which affects detection accuracy.
[0005] In one embodiment of this application, the driving device includes a motor, an outer sealing tube, and a detection component. The motor includes a motor housing with a detection port. The outer sealing tube extends axially through the motor into the interior of the motor housing and is fixedly connected to the motor housing. The distal end of the outer sealing tube has a side opening opposite to the detection port. The detection component includes a sensor and an inner sealing tube. The inner sealing tube is fixed inside the outer sealing tube, and its distal end extends to the inside of the side opening, with a sensing port corresponding to the side opening. The sensor has a probe and an optical fiber connected to the probe. The probe and part of the optical fiber are encapsulated in the inner sealing tube, and the probe corresponds to the sensing port.
[0006] In one embodiment, the detection port has opposing far and near edges; the inner sealing tube has a distal port for forming the sensing port, the distal port being located in the inner region between the far and near edges; the outer sealing tube has a guide wall located inside the side opening, the guide wall being spaced apart from the distal port by a guide groove.
[0007] In one embodiment, the guide wall has an outer end adjacent to the distal edge and an inner end adjacent to the distal port, the guide wall is inclined toward the distal port from its outer end to its inner end, and the inner end of the guide wall and the distal port are spaced apart by a first distance along the axial direction of the motor.
[0008] In one embodiment, the guide wall is configured as an inclined plane that is tilted relative to the axis of the outer sealing tube; or, the guide wall is configured as a concave arc surface that is recessed in the direction away from the distal end of the tube.
[0009] In one embodiment, the distal end of the inner sealing tube is disposed on a bisecting plane, which is a plane perpendicular to the axis of the motor and passing through the bisector of the axial length of the side opening; the relationship between the inclination angle θ of the guide wall relative to the axis of the motor, the axial length B of the side opening, and the inner diameter D2 of the outer sealing tube is: θ min ≤θ<90°, where θ min =arctan(D2 / 0.5B); or, the range of the tilt angle θ of the guide wall relative to the axis of the motor is: 30°≤θ≤50°.
[0010] In one embodiment, the proximal end of the outer sealing tube is provided with an opening for the insertion of the detection component, and the distal end of the outer sealing tube is provided with a sealing structure that closes the distal end of the outer sealing tube. The inner side of the sealing structure is filled with a third fixing adhesive, and the sidewall of the third fixing adhesive facing the distal end opening defines the guide wall.
[0011] In one embodiment, the detection port includes an inlet region and a positioning region, the inlet region corresponding to the guide channel along the radial direction of the motor; the positioning region corresponding to the distal end of the inner sealing tube along the radial direction of the motor;
[0012] Wherein, a first adhesive is provided in the positioning area, the first adhesive connecting and fixing the inner sealing tube to the outer sealing tube and the motor housing; and / or, the proximal end of the outer sealing tube extends to the proximal end of the motor housing and is connected and fixed to the motor housing by a second adhesive.
[0013] In one embodiment, the length of the inner sealing tube is less than the length of the outer sealing tube; the optical fiber of the sensor includes an inner optical fiber segment and an outer optical fiber segment connected together, wherein the inner optical fiber segment is connected to the probe and both the inner and outer optical fibers are encapsulated within the inner sealing tube, and the outer optical fiber segment is connected to the inner optical fiber segment and is at least partially housed within the outer sealing tube.
[0014] The length of the outer sealing tube is L1, and the length of the inner sealing tube is L2, wherein 0.2L1≤L2≤0.5L1; and / or, at least one of the outer sealing tube and the inner sealing tube is made of an organic polymer material.
[0015] In one embodiment, the inner sealing tube is filled with a first fixing adhesive and a second fixing adhesive. The first fixing adhesive fills the distal portion of the inner sealing tube and wraps the probe. A portion of the first fixing adhesive forms a conductive wall at the sensing port, and the conductive wall contacts the probe. The second fixing adhesive wraps at least a portion of the optical fiber located in the inner sealing tube.
[0016] 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; 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.
[0017] In one embodiment, the first fixing adhesive is a soft gel, and the second fixing adhesive is a soft gel or a hard gel; and / or, one end of the first fixing adhesive extends axially along the inner sealing tube to be flush with the distal end of the inner sealing tube, the other end of the first fixing adhesive is connected to the second fixing adhesive, and the end of the second fixing adhesive away from the first fixing adhesive extends axially along the inner sealing tube to be flush with the proximal end of the inner sealing tube.
[0018] This application also provides a blood pump, which includes a conduit and the aforementioned driving device, wherein the conduit is connected to the driving device and is used for the optical fiber of a sensor to pass through.
[0019] In one embodiment, the blood pump further includes a cannula assembly and an impeller; the cannula assembly is connected to the end of the drive device away from the catheter, 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.
[0020] In the aforementioned drive device, by encapsulating the sensor probe and part of the optical fiber within an inner sealing tube, the sensor of the detection component and the inner sealing tube are integrated into a single structure. This ensures the sensor is firmly fixed inside the inner sealing tube, preventing axial movement along the inner sealing tube. Furthermore, the inner sealing tube of the detection component is then fixed within an outer sealing tube, and finally, the outer sealing tube is fixed inside the motor housing. This effectively encapsulates the sensor within a double-tube structure composed of the inner and outer sealing tubes. Compared to traditional single-tube sensor encapsulation methods, this application, by first encapsulating the sensor within the inner sealing tube and then fixing it to the inside of the outer sealing tube, provides a larger mating surface between the outer and inner walls of the inner and outer sealing tubes. This results in a more stable assembly, preventing the inner sealing tube from moving axially along the outer sealing tube, further enhancing the sensor's encapsulation robustness and preventing axial movement. Attached Figure Description
[0021] 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.
[0022] 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.
[0023] 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:
[0024] Figure 1 This is a schematic diagram of the structure of a blood pump according to one embodiment.
[0025] Figure 2 for Figure 1 The blood pump shown is a cross-sectional view under section AA.
[0026] Figure 3 for Figure 2 The enlarged view of P1 shown.
[0027] Figure 4 for Figure 1 The blood pump shown is a cross-sectional view below the BB section.
[0028] Figure 5 for Figure 4 The image shows a magnified view of part P2.
[0029] Figure 6 This is a partial cross-sectional view of a drive device according to one embodiment.
[0030] Figure 7 This is a cross-sectional view of a detection component according to one embodiment.
[0031] Figure 8 This is a schematic diagram showing the structural division of the sensor in a driving device according to one embodiment.
[0032] Figure 9 This is a dimensional schematic diagram of a portion of the structure of a drive device according to one embodiment.
[0033] Figure 10 This is a dimensional schematic diagram of another part of the structure of the drive device according to one embodiment.
[0034] Figure 11 This is a partial cross-sectional view of a drive device according to another embodiment.
[0035] Figure 12 This is a schematic diagram of the structure of a detection component according to one embodiment.
[0036] Figure 13 This is a schematic diagram of the structure of an outer sealing tube according to one embodiment.
[0037] Explanation of reference numerals in the attached figures:
[0038] 10. Detection component; 11. Sensor; 111. Probe; 112. Optical fiber; 1121. Outer optical fiber segment; 1122. Inner optical fiber segment; 1123. First sub-segment; 1124. Second sub-segment; 12. Inner sealing tube; 121. Potting hole; 122. Sensing port; 123. Distal port; 124. Proximal port; 13. First fixing adhesive; 131. Conductive wall; 132. First inclined surface; 14. Second fixing adhesive; 2 0. External sealing tube; 21. Side opening; 22. Third fixing adhesive; 221. Guide wall; 222. Guide groove; 23. Closed structure; 24. Opening; 30. Motor; 31. Motor housing; 311. Detection port; 3111. Far edge; 3112. Near edge; 3113. Inlet area; 3114. Positioning area; 40. Catheter; 71. Sleeve assembly; 711. Blood outlet; 72. Impeller; AF. Bisector. Detailed Implementation
[0039] 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.
[0040] 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.
[0041] 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.
[0042] 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.
[0043] 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] In view of this, see Figures 1 to 3 This application provides a driving device and a blood pump in one embodiment. The blood pump includes the driving device, which drives the impeller 70 of the blood pump to rotate, thereby driving blood flow. For ease of understanding, the driving device will be described first in the following embodiments.
[0049] See Figures 2 to 5 In one embodiment, the driving device includes a motor 30, an outer sealing tube 20, and a detection assembly 10. The motor 30 includes a motor housing 31, which has a detection port 311 for blood flow. The outer sealing tube 20 extends axially through the motor 30 into the motor housing 31 and is fixedly connected to it. The outer sealing tube 20 has a side opening 21, which is opposite to the detection port 311. Figure 6 The detection component 10 is installed inside the outer sealing tube 20. The detection component 10 includes a sensor 11 and an inner sealing tube 12. The inner sealing tube 12 is fixed in the outer sealing tube 20. The distal end of the inner sealing tube 12 extends to the inside of the side opening 21 and is provided with a sensing port 122 corresponding to the side opening 21. The sensor 11 includes a probe 111 and an optical fiber 112 connected to the probe 111. The probe 111 and part of the optical fiber 112 are encapsulated in the inner sealing tube 12. The probe 111 corresponds to the sensing port 122 so as to sense blood through the sensing port 122.
[0050] For the motor housing 31, the detection port 311 of the motor housing 31 can be located at the far end of the motor housing 31 or at the middle of the motor housing 31. Specifically, the detection port 311 of the motor housing 31 is located at the far end of the motor housing 31, so that the detection port 311 is closer to the blood outlet 711 of the blood pump, so that the detection component 10 detects blood pressure that is closer to the pressure of the blood discharged from the blood outlet 711.
[0051] For the detection component 10, encapsulating the probe 111 and part of the optical fiber 112 of the sensor 11 within the inner sealing tube 12 means that the probe 111 and part of the optical fiber 112 are fixed and sealed within the inner sealing tube 12, so that the sensor 11 of the detection component 10 and the inner sealing tube 12 are integrated into a single structure. When a blood pump with this driving 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, where it is sensed by the probe 111 of the sensor 11 in the detection component 10, so that the sensor 11 can sense the blood pressure. Wherein, as... Figure 8 and Figure 12 As shown, the inner sealing tube 12 has a distal port 123 and a proximal port 124; the distal port 123 of the inner sealing tube 12 can be used as the sensing port 122. Of course, in other embodiments, the distal port 123 of the inner sealing tube 12 can also be closed, and a sensing port 122 can be additionally formed on the side wall at the distal end of the inner sealing tube 12.
[0052] In the aforementioned drive device, by encapsulating the probe 111 and part of the optical fiber 112 of the sensor 11 in the inner sealing tube 12, the sensor 11 of the detection component 10 and the inner sealing tube 12 are integrated into a single structure. This ensures that the sensor 11 is firmly fixed inside the inner sealing tube 12, preventing it from easily moving along the axial direction of the inner sealing tube 12. Furthermore, the inner sealing tube 12 of the detection component 10 is fixed in the outer sealing tube 20, and finally, the outer sealing tube 20 is fixed inside the motor housing 31. This is equivalent to encapsulating the sensor 11 in a double-tube structure composed of the inner sealing tube 12 and the outer sealing tube 20. Compared to the traditional single-tube packaging method for sensors, this application first encapsulates the sensor 11 inside the inner sealing tube 12, and then fixes it to the inside of the outer sealing tube 20 through the inner sealing tube 12. The outer peripheral wall of the inner sealing tube 12 and the inner peripheral wall of the outer sealing tube 20 have a larger mating surface, which makes the connection and assembly of the inner sealing tube 12 and the outer sealing tube 20 more stable. The inner sealing tube 12 is not easy to move along the axial direction of the outer sealing tube 20, which can further improve the robustness of the sensor 11 packaging and prevent the sensor 11 from moving along the axial direction.
[0053] With the outer sealing tube 20 fixed to the motor housing 31, optionally, the inner sealing tube 11 can be configured to have an interference fit with the outer sealing tube 20. With this configuration, even if the adhesive at the detection port 311 loosens, the interference fit between the inner sealing tube 11 and the outer sealing tube 20 prevents the detection component 10 from easily moving within the outer sealing tube 20, allowing the detection component 10 to perform its detection function correctly. 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.
[0054] Considering that after the blood pump is inserted into the patient's body, the blood in the blood vessels flows along the axis of the blood pump. When the blood reaches the detection port 311 of the blood pump, part of the blood flow changes from axial to radial, turning into the detection port 311 at a deflection angle of nearly 90°. This part of the blood impacts the inner wall of the outer sealing tube 20 vertically and then turns 90° axially towards the probe 111 of the sensor 11, so that the probe 111 of the sensor 11 can sense the blood pressure. During this process, the angle change of the blood flow is too large, and the pressure is reduced to a certain extent, which may lead to inaccurate detection results from the detection component 10.
[0055] See Figures 6 to 8 To improve the above problems, in one embodiment, the detection port 311 has a distal edge 3111 and a proximal edge 3112, which are opposite each other along the axial direction of the motor 30. The inner sealing tube 12 has a distal port 123 for forming the sensing port 122, which is located in the inner region between the distal edge 3111 and the proximal edge 3112. The outer sealing tube 20 has a guide wall 221 located inside the side opening 21, and a guide groove 222 is spaced between the guide wall 221 and the distal port 123 (i.e., the sensing port 122). The guide groove 222 is used to guide blood flow from the detection port 311 to the distal port 123.
[0056] Specifically, the distal end 123 of the inner sealing tube 12 serves as the sensing port 122. A guide wall 221 is located distal to the distal end 123 of the inner sealing tube 12, and is inclined relative to the axis of the motor 10. After blood flows sequentially through the detection port 311 and the side opening 21, it enters the guide groove 222 and then flows smoothly along the guide wall 221 to the distal end 123 of the inner sealing tube 12 (i.e., the sensing port 122) for detection by the probe 111. This reduces the deflection angle of the blood flow from the detection port 311 to the sensing port 122, ensuring the deflection angle is less than 90°. This avoids large-angle abrupt changes in blood flow direction, effectively reducing blood pressure loss and improving the detection accuracy of the sensor 11.
[0057] See Figure 8 and Figure 13 Optionally, in one embodiment, the proximal end of the outer sealing tube 20 is provided with an opening 24, so that the detection component 10 can be inserted into the outer sealing tube 20 through the opening 24 at the proximal end of the outer sealing tube 20, which is simple to operate. The distal end of the outer sealing tube 20 may be provided with a closing structure 23, which closes the distal end of the outer sealing tube 20. Theoretically, with the flow guide wall 221 provided on the outer sealing tube 20, the flow guide wall 221 can be molded together with the outer sealing tube 20 (i.e., integrally molded). However, considering that the diameter of the outer sealing tube 20 is small, the mold for manufacturing the outer sealing tube 20 is also small. If the flow guide wall 221 is to be molded together with the outer sealing tube 20, the mold needs to be modified, the precision is difficult to control, the manufacturing may be difficult, and the cost will increase relatively.
[0058] Therefore, a simpler method for providing a flow guide wall 221 on the outer sealing tube 20 is provided here. Specifically, a third fixing adhesive 22 is filled inside the sealing structure 23, and the sidewall of the third fixing adhesive 22 facing the distal end opening 123 (i.e., the sensing port 122) of the inner sealing tube 12 defines the flow guide wall 221. During manufacturing, after the outer sealing tube 20 is formed, adhesive liquid can be applied from the side opening 21 of the outer sealing tube 20 to the inside of the sealing structure 23. During the curing process, the adhesive liquid will spread towards the distal end opening 123 of the inner sealing tube 12 due to gravity (equivalent to spreading towards the inner sealing tube 12). Figure 6 (Spreading out to the lower right of the view shown), thus the third fixing adhesive 22 formed by the curing of the adhesive has a sidewall that extends obliquely toward the distal end port 123 of the inner sealing tube 12, and the sidewall can serve as a guide wall 221. It can be seen that this setting method is simple to operate and has low cost.
[0059] Furthermore, since a sealing structure 23 is provided at the distal end of the outer sealing tube 20, the sealing structure 23 can prevent the adhesive used to form the third fixative 22 from overflowing from the distal end of the outer sealing tube 20 during injection. Simultaneously, after the third fixative 22 solidifies to form the guide wall 221, it can also support the third fixative 22, thereby enhancing its firmness and preventing it from loosening due to blood flow. Optionally, the third fixative 22 is a rigid gel, thus improving the firmness and durability of the guide wall 221.
[0060] See Figure 8 and Figure 9 In one embodiment, the flow guide wall 221 has an outer end adjacent to the distal edge 3111 and an inner end adjacent to the distal port 123 (i.e., the sensing port 122). The flow guide wall 221 is inclined from its outer end to its inner end toward the distal port 123, so that after the blood enters from the side opening 21 of the outer sealing tube 20, it can flow obliquely along the flow guide wall 221 toward the distal port 123 of the inner sealing tube 12 without vertically impacting the inner wall surface of the outer sealing tube 20.
[0061] Furthermore, the inner end of the flow guide wall 221 is axially spaced by a first distance D1 from the sensing port 122. That is, the inner end of the flow guide wall 221 does not contact the distal end port 123 of the inner sealing tube 12. Because the flow guide wall 221 is formed of the third fixing adhesive 22, if the adhesive used to form the third fixing adhesive 22 comes into contact with the distal end port 123 of the inner sealing tube 12 during injection, it may adhere to the sensor 11 at the distal end port 123 or the conductive wall 131 in contact with the sensor 11, resulting in a decrease in the sensitivity of the conductive wall 131 or the sensor 11 in sensing blood pressure. Therefore, axially separating the inner end of the flow guide wall 221 from the sensing port 122 by a first distance D1 can prevent the adhesive of the flow guide wall 221 from adhering to the detection component 10, thereby preventing the flow guide wall 221 from interfering with the detection accuracy of the detection component 10.
[0062] See Figure 8 and Figure 9 In one embodiment, the inclination angle of the guide wall 221 relative to the axis of the outer sealing tube 20 is θ, then θ min ≤θ<90°, where θ min This represents the minimum limit of the tilt angle θ, when θ = θ min At this time, the inner end of the guide wall 221 extends exactly to the sensing port 122. The sensing port 122 is formed based on the distal end port 123 of the inner sealing tube 12. Optionally, the distal end port 123 of the inner sealing tube 12 is positioned on a bisecting plane AF, which is a plane perpendicular to the axis of the motor 30 and passing through the bisector of the axial length of the side opening 21. In this case, it is equivalent to positioning the distal end port 123 of the inner sealing tube 12 at the midpoint of the axial length of the side opening 21. This allows the detection component 10 to be viewed from the side opening 21 and facilitates further fixation by bonding the outer sealing tube 20 to the detection component 10 and the motor housing 30 at the side opening 21.
[0063] Based on the fact that the distal end port 123 of the inner sealing tube 12 is located on the bisecting plane AF, the side opening 21 has an axial length B, and the axial distance between the distal end port 123 of the inner sealing tube 12 and the distal edge of the side opening 21 is 0.5B, based on this, the minimum limit θ min The relationship between the axial length B of the side opening 21 and the inner diameter D2 of the outer sealing tube 20 can be derived from geometric principles: θ min =arctan(D² / 0.5B). That is to say, the relationship between the inclination angle θ of the guide wall 221, the axial length B of the side opening 21, and the inner diameter D² of the outer sealing tube 20 is: θ min ≤θ<90°, and θ min =arctan(D² / 0.5B). Understandably, at θ... minWithin the range of ≤θ<90°, the smaller the tilt angle θ, the better the guiding effect of the guide wall 221. It should also be noted that the size of the side opening 21 of the outer sealing tube 20 is the same as or smaller than the detection port 311.
[0064] In another embodiment, the distal port 123 of the inner sealing tube 12 may not be located on the bisecting plane AF. In this case, the inclination angle θ of the guide wall 221 relative to the axis of the outer sealing tube 20 can be selected from 30°≤θ≤50°. The inclination angle θ can be, but is not limited to, 32°, 35°, 40°, 44°, and 49°. In this way, the guide wall 221 can be guaranteed to have a good guiding effect, while avoiding the guide wall 221 from extending to the sensing port 122 and contacting the detection component 10.
[0065] See Figure 9 Optionally, in one embodiment, the guide wall 221 is configured as an inclined plane relative to the axis of the outer sealing tube 20. See also Figure 11 In another embodiment, the flow guide wall 221 may also be configured as a concave arc surface recessed in the direction away from the distal port 123 (i.e., the sensing port 122). Preferably, the concave arc surface flow guide wall 221 can be formed by pressing the third fixative 22 with a spherical tool before the third fixative 22 is fully cured.
[0066] See Figure 9 and Figure 10 The length of the outer sealing tube 20 is L1, and the length of the inner sealing tube 12 is L2, where L2 < L1, meaning the inner sealing tube 12 is shorter than the outer sealing tube 20. This reduces material consumption and saves costs. Furthermore, while ensuring good fixation of the inner sealing tube 12 within the outer sealing tube 20, it also reduces the axial contact area between the inner sealing tube 12 and the inner wall of the outer sealing tube 20 during insertion, thus reducing the resistance encountered by the inner sealing tube 12 during insertion and making it easier to insert. Optionally, 0.2L1 ≤ L2 ≤ 0.5L1.
[0067] Preferably, at least one of the outer sealing tube 20 and the inner sealing tube 12 is made of an organic polymer material. For example, if the inner sealing tube 12 is made of an organic polymer material, it will have a certain degree of ductility. When the outer diameter of the inner sealing tube 12 is slightly larger than the inner diameter of the outer sealing tube 20, the inner sealing tube 12 can be stretched to slightly reduce its outer diameter, allowing it to be inserted into the outer sealing tube 20. Conversely, the inner sealing tube 12 can also be expanded to increase both its inner and outer diameters.
[0068] See Figure 11The detection port 311 includes an inlet region 3113 and a positioning region 3114. The inlet region 3113 corresponds to the guide channel 221 radially along the motor 30; the positioning region 3114 corresponds to the distal end of the inner sealing tube 12 radially along the motor 30. A first adhesive is provided in the positioning region 3114, which connects and fixes the inner sealing tube 12, the outer sealing tube 20, and the motor housing 31. Furthermore, the proximal end of the outer sealing tube 20 extends to the proximal end of the motor housing 31, and the proximal end of the outer sealing tube 20 is connected and fixed to the motor housing 31 by a second adhesive, thus strengthening the connection stability between the outer sealing tube 20 and the motor housing 31 at the proximal end of the outer sealing tube 20. Since both the first and second adhesives are far from the probe 111, both the first and second adhesives can be selected as hard adhesives.
[0069] See Figure 6 and Figure 8 In one embodiment, the optical fiber 112 of the sensor 11 includes an inner optical fiber segment 1122 and an outer optical fiber segment 1121 connected together. The inner optical fiber segment 1122 is connected to the probe 111, and both the inner optical fiber segment 1122 and the probe 111 are encapsulated within an inner sealing tube 12. The outer optical fiber segment 1121 is connected to the inner optical fiber segment 1122, and at least a portion of the outer optical fiber segment 1121 is housed within an outer sealing tube 20. The position where the outer optical fiber segment 1121 protrudes from the proximal end of the outer sealing tube 20 can also be bonded and fixed to the outer sealing tube 20 and the motor housing 31 using the second adhesive.
[0070] See Figure 7 Optionally, in one embodiment, the inner sealing tube 12 is filled with a first fixing adhesive 13 and a second fixing adhesive 14. The first fixing adhesive 13 fills the distal portion of the inner sealing tube 12 and wraps around the probe 111. A portion of the first fixing adhesive 13 forms a conductive wall 131 at the sensing port 122, which contacts the probe 111 to transmit pressure. The second fixing adhesive 14 wraps around at least a portion of the optical fiber 112 located in the inner sealing tube 12.
[0071] Specifically, the probe 111 of the sensor 11 is wrapped with a first fixing adhesive 13, and the optical fiber 112 located in the inner sealing tube 12 is wrapped with a second fixing adhesive 14. In this way, most of the sensor 11 is sealed in the inner sealing tube 12, so that the sensor 11 is firmly fixed in the inner sealing tube 12 and is not easy to move along the axial direction of the inner sealing tube 12. Simultaneously, 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, the conductive wall 131 seals the sensing port 122 and contacts the probe 111, preventing blood from entering the inner sealing tube 12 from the sensing port 122. However, blood pressure can be transmitted to the probe 11 through the conductive wall 131. This ensures that the sensor 11 can detect blood pressure normally while fixing it. Furthermore, the conductive wall 131 and the portion of the first fixing adhesive 13 covering 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. Preferably, the conductive wall 131 is flush with the end face of the sensing port 122.
[0072] See Figure 7 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.
[0073] See Figure 7 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.
[0074] 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.
[0075] See Figure 6 and Figure 8 Furthermore, the inner fiber segment 1122 of the optical fiber 112 includes a first sub-segment 1123 connected to the probe 111, and a second sub-segment 1124 connected to the first sub-segment 1123. The first fixing adhesive 13 also wraps the first sub-segment 1123 and its connection point with the probe 111; the second fixing adhesive 14 wraps the second sub-segment 1124. Preferably, the probe 111 is welded to the first sub-segment 1123, and a solder joint is formed at the weld between the probe 111 and the first sub-segment 1123, 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.
[0076] Furthermore, one end of the first fixing adhesive 13 extends axially along the inner sealing tube 12 to be flush with the distal end 123 of the inner sealing tube 12, and 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 axially along the inner sealing tube 12 to be flush with the proximal end 124 of the inner sealing tube 12. 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.
[0077] See Figure 6 , Figure 7 and Figure 12 Optionally, in one embodiment, the inner sealing tube 12 has a filling hole 121 on its side for injecting the second fixing adhesive 14. See also Figure 7 The first fixing adhesive 13 forms a first inclined surface 132 on the inner side of the injection hole 121, and the second fixing adhesive 14 is bonded and fixed to the first 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 injection hole 121 after the first fixing adhesive 13 has partially solidified.
[0078] 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 first inclined surface 132 formed on the inner side of the potting hole 121, the first inclined surface 132 is inclined relative to the axial direction of the inner sealing tube 12, so that the first 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 124124 of the inner sealing tube 12, so that the air in the inner sealing tube 12 is discharged from the proximal end port 124124, 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 12, 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.
[0079] Optionally, after the detection component 10 is inserted into the interior of the outer sealing tube 20, the glue-filling hole 121 on the side wall of the inner sealing tube 12 of the detection component 10 is covered by the side wall of the outer sealing tube 20 to prevent the glue-filling hole 121 from being exposed inside the side opening 21 of the outer sealing tube 20, thereby reducing the flushing of blood on the glue-filling hole 121 and reducing the risk of blood entering through the glue-filling hole 121.
[0080] Finally, it should be noted that a sealing structure (such as sealant) is usually provided between the periphery of the detection port 311 of the motor housing 31 and the outer peripheral wall of the outer sealing tube 20 to seal the gap between the periphery of the detection port 311 of the motor housing 31 and the outer peripheral wall of the outer sealing tube 20, so as to prevent blood from entering the interior of the motor housing 31 through the gap. The specifics will not be elaborated here.
[0081] See Figures 1 to 3 In another aspect, this application also provides a blood pump. Specifically, in one embodiment, the blood pump includes a catheter 40 and a drive device of any of the above embodiments, with the catheter 40 connected to the drive device. The catheter 40 is used for the optical fiber 112 of the sensor 11 to pass through. Further, the catheter 40 can also be used to pass through a control cable for the drive device and a flushing line, wherein the control cable is used to transmit electrical signals, and the flushing line delivers cleaning fluid or lubricating fluid, such as saline or heparin, to the drive device for flushing, which will not be elaborated here.
[0082] 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.
[0083] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0084] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are quite specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.
Claims
1. A driving device, characterized in that, The driving device includes: An electric motor, the electric motor including a motor housing, the motor housing having a detection port; An outer sealing tube is inserted into the motor housing along the axial direction of the motor and is fixedly connected to the motor housing. The distal end of the outer sealing tube has a side opening opposite to the detection port. The system also includes a detection component comprising a sensor and an inner sealing tube; wherein the inner sealing tube is fixed inside the outer sealing tube, the distal end of the inner sealing tube extends to the inside of the side opening, and is provided with a sensing port corresponding to the side opening; the sensor has a probe and an optical fiber connected to the probe, the probe and part of the optical fiber are encapsulated in the inner sealing tube, and the probe corresponds to the sensing port. The outer sealing tube has a guide wall inside the side opening. The guide wall is inclined relative to the axis of the motor. A guide groove is spaced between the guide wall and the sensing port. Blood flow passing through the detection port and the side opening can enter the guide groove.
2. The driving device according to claim 1, characterized in that, The detection port has a relative far edge and a near edge; the inner sealing tube has a distal end for forming the sensing port, the distal end being located in the inner region between the far edge and the near edge.
3. The driving device according to claim 2, characterized in that, The guide wall has an outer end adjacent to the distal edge and an inner end adjacent to the distal port. The guide wall is inclined toward the distal port from its outer end to its inner end. The inner end of the guide wall and the distal port are spaced apart by a first distance along the axial direction of the motor.
4. The driving device according to claim 2, characterized in that, The guide wall is configured as an inclined plane that is tilted relative to the axis of the outer sealing tube; or, the guide wall is configured as a concave arc surface that is recessed in the direction away from the distal end of the tube.
5. The driving device according to any one of claims 2 to 4, characterized in that, The distal end of the inner sealing tube is positioned on a bisecting plane, which is a plane perpendicular to the axis of the motor and passing through the bisector of the axial length of the side opening; the relationship between the inclination angle θ of the guide wall relative to the axis of the motor, the axial length B of the side opening, and the inner diameter D2 of the outer sealing tube is: θ min ≤θ<90°, where θ min =arctan(D² / 0.5B); Alternatively, the tilt angle θ of the guide wall relative to the axis of the motor is in the range of 30°≤θ≤50°.
6. The driving device according to any one of claims 2 to 4, characterized in that, The proximal end of the outer sealing tube is provided with an opening for the insertion of the detection component, and the distal end of the outer sealing tube is provided with a sealing structure. The sealing structure closes the distal end of the outer sealing tube, and the inner side of the sealing structure is filled with a third fixing adhesive. The sidewall of the third fixing adhesive facing the distal end opening defines the guide wall.
7. The driving device according to any one of claims 2 to 4, characterized in that, The detection port includes an inlet area and a positioning area. The inlet area corresponds to the flow guide groove along the radial direction of the motor. The positioning area corresponds to the distal end of the inner sealing tube along the radial direction of the motor. Wherein, a first adhesive is provided in the positioning area, the first adhesive connecting and fixing the inner sealing tube to the outer sealing tube and the motor housing; and / or, the proximal end of the outer sealing tube extends to the proximal end of the motor housing and is connected and fixed to the motor housing by a second adhesive.
8. The driving device according to any one of claims 1 to 4, characterized in that, The inner sealing tube and the outer sealing tube are interference-fitted; or, the length of the inner sealing tube is less than the length of the outer sealing tube; the optical fiber of the sensor includes an inner optical fiber segment and an outer optical fiber segment connected together, wherein the inner optical fiber segment is connected to the probe and both the inner and outer optical fibers are encapsulated in the inner sealing tube, and the outer optical fiber segment is connected to the inner optical fiber segment and is at least partially housed in the outer sealing tube.
9. The driving device according to any one of claims 1 to 4, characterized in that, The length of the outer sealing tube is L1, and the length of the inner sealing tube is L2, wherein 0.2L1≤L2≤0.5L1; and / or, at least one of the outer sealing tube and the inner sealing tube is made of an organic polymer material.
10. The driving device according to any one of claims 1 to 4, characterized in that, The inner sealing tube is filled with a first fixing adhesive and a second fixing adhesive. The first fixing adhesive fills the distal portion of the inner sealing tube and wraps the probe. A portion of the first fixing adhesive forms a conductive wall at the sensing port, and the conductive wall contacts the probe. The second fixing adhesive wraps at least a portion of the optical fiber located in the inner sealing tube.
11. The driving device according to claim 10, 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.
12. The driving device according to claim 10, characterized in that, The first fixing adhesive is a soft gel, and the second fixing adhesive is a soft gel or a hard gel; and / or, one end of the first fixing adhesive extends along the axial direction of the inner sealing tube to be flush with the distal end of the inner sealing tube, the other end of the first fixing adhesive is connected to the second fixing adhesive, and the end of the second fixing adhesive away from the first fixing adhesive extends along the axial direction of the inner sealing tube to be flush with the proximal end of the inner sealing tube.
13. A blood pump, characterized in that, The blood pump includes a catheter and a drive device according to any one of claims 1-12, the catheter being connected to the drive device, and the catheter being used for the passage of an optical fiber from a sensor.
14. The blood pump as claimed in claim 13, characterized in that, The blood pump also includes: A cannula assembly, connected to the end of the drive device remote from the catheter, 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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