Measuring device

Abstract

The present disclosure provides a measuring device including a plurality of sensor assemblies and a first pipe body, the sensor assembly including a second pipe body, a sensor positioned inside the second pipe body, and a conducting portion through which the sensor measures a parameter outside the second pipe body, the sensor assembly being fixedly connected to the first pipe body along an axial direction of the measuring device, the second pipe body having a rigidity greater than that of the first pipe body. According to the present disclosure, a measuring device having high measurement stability and being easy to assemble can be provided.

Description

Technical Field

[0001] This disclosure relates to the biomedical engineering industry, specifically to a measuring device. Background Technology

[0002] Cardiovascular disease is one of the major health problems worldwide. These diseases typically require diagnostic tools to assess the health of blood vessels, and measuring catheters are a key one. Measuring catheters are generally equipped with sensors and can be inserted into the blood vessel to measure parameters such as blood pressure, degree of stenosis, blood flow velocity, and oxygen saturation. Accurate measurement results are crucial for determining the severity of the lesion, developing treatment plans, and evaluating surgical outcomes. Because multiple complex lesion areas may need to be assessed during the diagnosis and treatment of cardiovascular diseases, multiple sensors are usually placed at multiple locations on the measuring catheter to facilitate a comprehensive understanding of the vascular condition.

[0003] In existing technologies, there are generally two ways to arrange sensors: the first is to place the sensor on the outside of the measuring catheter, which facilitates sensor placement. The second is to place the sensor inside the measuring catheter, which keeps the outer diameter of the measuring catheter smaller, making it more suitable for insertion into complex vascular structures.

[0004] However, both of these arrangements present challenges: the large overall outer diameter of the measuring catheter makes it difficult to pass through narrow or tortuous blood vessels; and the placement of the sensor inside the measuring catheter makes manufacturing and assembly difficult. Furthermore, to minimize damage to blood vessels, measuring catheters are typically flexible, which means that the internal sensor may be subjected to external pressure when passing through tortuous blood vessels, posing a risk of damage. Summary of the Invention

[0005] This disclosure is made in view of the above-mentioned state of the prior art, and its purpose is to provide a measuring device with high measurement stability and easy assembly.

[0006] To this end, this disclosure provides a measuring device, including a plurality of sensor assemblies and a first tube. The sensor assembly includes a second tube, a sensor located inside the second tube, and a conductive part. The sensor measures parameters outside the second tube via the conductive part. The sensor assembly is fixedly connected to the first tube along the axial direction of the measuring device. The stiffness of the second tube is greater than that of the first tube.

[0007] In this disclosure, the sensor assembly of the measuring device is independent and can be assembled with the first tube. Compared with the solution of directly setting multiple sensors in a single conduit, this disclosure facilitates the assembly of the measuring device by setting an independent sensor assembly including a second tube and adjusting the position and number of the sensor assembly in the measuring device according to actual needs. In addition, setting the sensor in the second tube, which has greater rigidity, can reduce the risk of the overall diameter of the second tube being too large, and can also improve the sensor's resistance to external forces through the protection of the second tube. This reduces the risk of the sensor being damaged by excessive external pressure during operation (e.g., when passing through a highly curved blood vessel), thereby helping to improve the measurement stability of the measuring device.

[0008] Additionally, in the measuring device disclosed herein, optionally, two adjacent sensor assemblies are connected via the first tube. In this case, since the stiffness of the second tube of the sensor assembly is greater than that of the first tube, connecting two adjacent sensor assemblies via the first tube facilitates the establishment of a flexible connection between them, thereby enabling the two adjacent sensor assemblies to pass through complex lesion areas and improving the passability of the measuring device.

[0009] Alternatively, in the measuring device disclosed herein, the second tube body and the first tube body may be fixedly connected by means of sleeve connection, screw connection, adhesive bonding, and / or thermofusion welding. In this case, sleeve connection, screw connection, adhesive bonding, and / or thermofusion welding can help to stably connect the first tube body and the second tube body.

[0010] Additionally, in the measuring device disclosed herein, optionally, at least one end of the second tube has at least one connecting hole, and the first tube is fitted onto the second tube to cover the connecting hole, and at least a portion of the first tube is deformed by hot-melt welding to embed into the connecting hole. In this case, deforming at least a portion of the first tube to embed into the connecting hole of the second tube by hot-melt welding can further improve the stability of the fixed connection between the first tube and the second tube.

[0011] Additionally, in the measuring device disclosed herein, optionally, the second tube includes a main body and a first end and a second end located at opposite ends of the main body, wherein the outer diameter of at least one of the first end and the second end is smaller than the outer diameter of the main body and matches the inner diameter of the first tube. In this case, by making the outer diameter of the first end and / or the second end smaller than the outer diameter of the main body, it is easier for the first end and / or the second end to be embedded in the first tube, thereby improving the stability of the connection between the first tube and the second tube. Furthermore, by making the diameter of the first end and / or the second end match the inner diameter of the first tube, it is easier for the first end and / or the second end to be embedded inside the first tube and the shaking of the first end and / or the second end within the first tube is reduced, thereby further improving the stability of the fixed connection between the first tube and the second tube.

[0012] Furthermore, in the measuring device disclosed herein, optionally, the outer diameter of the first tube is equal to the outer diameter of the second tube. This improves the smoothness of the connection between the first and second tubes, thereby enhancing the permeability of the measuring device and reducing damage to lumens (e.g., blood vessels).

[0013] Furthermore, in the measuring device disclosed herein, optionally, each sensor in the plurality of sensor assemblies is independently selected from any one of a temperature sensor, a pressure sensor, a blood flow sensor, a blood oxygen saturation sensor, and an ultrasonic transducer. This allows for the selection of appropriate sensors according to actual needs, expanding the applicability of the measuring device.

[0014] Additionally, in the measuring device disclosed herein, the sensor assembly may optionally include a wire connected to the sensor, the wire extending outward through the first tube and the second tube. In this case, by connecting the wire to the sensor and extending it outward, it is convenient to acquire multiple physiological parameters measured by the measuring device.

[0015] According to this disclosure, a measuring device with high measurement stability and easy assembly can be provided. Attached Figure Description

[0016] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings.

[0017] Figure 1 This is a diagram illustrating an application scenario of the measuring device involved in the examples of this disclosure.

[0018] Figure 2 This is a partial schematic diagram of the measuring device involved in the example of this disclosure in the target area.

[0019] Figure 3AThis is a schematic diagram illustrating the structure of a first embodiment of the second tube body involved in the example of this disclosure.

[0020] Figure 3B This is a schematic diagram illustrating the structure of a second embodiment of the second tube body involved in the example of this disclosure.

[0021] Figure 4 This is a schematic diagram illustrating the internal structure of the sensor assembly involved in the example of this disclosure.

[0022] Figure 5A It shows Figure 3A A schematic diagram of the connection between the second tube and the first tube.

[0023] Figure 5B It shows Figure 3B A schematic diagram of the connection between the second tube and the first tube.

[0024] Figure 6A This is a schematic diagram showing the first tube body and the second tube body after thermal fusion welding according to the example of this disclosure.

[0025] Figure 6B This is a schematic diagram showing the first tube body involved in the example of this disclosure flowing into the connection hole after hot-melt welding.

[0026] Figure 7 This is a schematic diagram illustrating the structure of the tip component involved in the example of this disclosure.

[0027] Figure 8 This is a flowchart illustrating a method for assembling the measuring device involved in the example of this disclosure.

[0028] Explanation of reference numerals in the attached figures:

[0029] 1… Measuring device, 11… Sensor assembly, 111… Second tube, 1111… Connecting hole, 1112… Main body, 1113… First end, 1114… Second end, 112… Sensor, 112a… First sensor, 112b… Second sensor, 113… Conducting part, 1131… Opening, 1132… Conducting layer, 114… Wire, 115… Core wire, 116… Fixing part, 12… First tube, 13… Tip assembly, 131… Imaging component, 1311… Imaging ring, 1312… Third tube, 132… Exchange component, 1321… Outer tube, 1322… Inner tube, 1323… Exchange port, 2… Lumen, 3… Patient, A… Target area. Detailed Implementation

[0030] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures.

[0031] It should be noted that the terms "comprising" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device that includes or has a series of steps or units, are not necessarily limited to those steps or units that are explicitly listed, but may include or have other steps or units that are not explicitly listed or that are inherent to such processes, methods, products, or devices.

[0032] It should be noted that in this article, relative position and direction terms such as "above", "facing upward", "below", "facing downward", "up and down direction", "left side", "facing left side", "left side", "facing left side", "right side", "facing right side", "right side", "facing right side", "left and right direction", "front", "facing forward", "back", "facing backward", and "front and back direction" are used with reference to the usual operating posture and should not be considered as restrictive.

[0033] The measuring device described in this disclosure can be used to acquire multiple physiological parameters of a target area. In some examples, the measuring device described in this disclosure may also be referred to as a measuring catheter, a monitoring catheter, an intravascular catheter, a multi-parameter measuring catheter, a multi-sensor catheter, or a measuring catheter with a multi-sensor structure, etc.

[0034] In this disclosure, the measuring device can measure physiological parameters external to it. In some examples, the measuring device can be placed in a target area to measure the physiological parameters of the target area. In some examples, the target area can be a lesion area of ​​a lumen; for a vascular lumen, the target area can be a suspected lesion area of ​​the vascular lumen, such as a stenotic segment of a blood vessel. However, the lumines involved in the examples of this disclosure are not limited to vascular lumines, but can also be lumines related to an organism, such as the esophagus, intestine, or ureter.

[0035] In some examples, for the lumen to be a blood vessel lumen, the physiological parameters can be the physiological parameters of the blood vessel lumen, such as blood temperature, lumen pressure, blood flow velocity, and / or blood oxygen saturation.

[0036] In some examples, passability can refer to the ability of a measuring device to traverse tortuous or diseased areas. In other examples, measurement stability can refer to the ability of a measuring device to resist external influences and maintain normal measurement.

[0037] The measuring device involved in the present disclosure will be described in detail below with reference to the accompanying drawings.

[0038] Figure 1 This diagram illustrates an application scenario of the measuring device 1 involved in the examples of this disclosure. Figure 1 In this illustration, the structure of measuring device 1 has been simplified for clarity, but this should not be construed as a limitation of this disclosure.

[0039] See in some examples Figure 1 The measuring device 1 can enter the lumen 2, and the target area A can be a diseased area in the lumen 2. In some examples, the measuring device 1 can assist the operator (e.g., a doctor) in diagnosing the health status of the patient 3 by measuring physiological parameters in the lumen 2 (e.g., determining the location of the target area A in the lumen 2 and / or the degree of lesion in the target area A). In some examples, the end of the measuring device 1 furthest from the operator can be the distal end, and the end closest to the operator can be the proximal end.

[0040] For ease of description, some examples below use lumen 2 as the vessel lumen, target region A as the lesion area of ​​the vessel lumen, and physiological parameters as the physiological parameters of the vessel lumen. It should be noted that this does not imply limitation of this disclosure, and unless there is a contradiction, the relevant descriptions also apply to other lumens.

[0041] In some examples, the measuring device 1 can pass through and cover the target region A, where covering can mean that the length of the measuring device 1 is greater than the length of the target region A. This allows the measuring device 1 to acquire multiple physiological parameters at various locations within the target region A more comprehensively.

[0042] Figure 2 This is a partial schematic diagram showing the measuring device 1 according to an example of this disclosure in target area A. Figure 2 In this illustration, the ratio of the target area A to the measuring device 1 has been adapted for clarity, but this should not be construed as a limitation of this disclosure.

[0043] See in some examples Figure 2 The measuring device 1 may include a sensor assembly 11. In some examples, the sensor assembly 11 may measure physiological parameters of the lumen 2.

[0044] In some examples, sensor assembly 11 can exist independently. For example, independent existence can mean that sensor assembly 11 is a separate component or part, that sensor assembly 11 can be manufactured independently, or that the position and number of sensor assembly 11 in the measuring device 1 can be independently adjusted according to actual needs. This facilitates the processing and assembly of the measuring device 1.

[0045] See in some examples Figure 2 The sensor assembly 11 can be distributed on the measuring device 1 along the axial direction of the measuring device 1.

[0046] See in some examples Figure 2 There can be multiple sensor components 11. This allows the measuring device 1 to acquire physiological parameters at multiple locations within the lumen 2. In some examples, adjacent sensor components 11 can be interconnected. In some examples, the spacing between adjacent sensor components 11 can be equal. In some examples, the spacing between adjacent sensor components 11 can be from 0.1 cm to 10 cm. For example, the spacing can be 0.1 cm, 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 8 cm, or 10 cm. Preferably, the spacing can be from 1 cm to 5 cm.

[0047] However, this disclosure is not limited to this. The number of sensor components 11 can be selected according to requirements. For example, when measuring a single area, only one sensor component 11 is needed to meet the measurement requirements. In this case, a measuring device 1 containing only one sensor component 11 can be selected. In other words, this disclosure can also provide a solution where the measuring device 1 includes only one sensor component 11.

[0048] In some examples, the sensor assembly 11 can be a single unit. This facilitates the assembly of the measuring device 1.

[0049] Figure 3A This is a schematic diagram illustrating the structure of a first embodiment of the second tube 111 involved in the example of this disclosure. Figure 3B This is a schematic diagram illustrating the structure of a second embodiment of the second tube 111 involved in the example of this disclosure.

[0050] In some examples, sensor assembly 11 may include a second tube 111 (see Figure 3A or Figure 3B (See some examples.) Figure 3A The radial dimensions of each part of the second tube 111 can be equal. See some examples. Figure 3A The outer diameters at both ends of the second tube 111 can be equal to the outer diameter of the middle part of the second tube 111.

[0051] See in some examples Figure 3B The radial dimensions of the various parts of the second tube 111 may not be equal. See some examples. Figure 3B The outer diameters at both ends of the second tube 111 can be smaller than the outer diameter of the middle part of the second tube 111.

[0052] In some examples, the size of the second tube 111 can be made as small as possible. This allows for maximizing the passability of the measuring device 1.

[0053] In some examples, the dimensions (e.g., length and inner / outer diameter) of the second tube 111 can match the dimensions of the sensor 112. In other words, the dimensions of the second tube 111 can be close to the dimensions of the sensor 112, either slightly larger than, equal to, or slightly smaller than the dimensions of the sensor 112. It should be noted that when the dimensions of the second tube 111 are slightly smaller than the dimensions of the sensor 112, a portion of the sensor 112 will extend out of the second tube 111 and be located within the first tube 12 (described later). Except for a very few extreme cases (e.g., excessive bending at the connection between the first tube 12 and the second tube 111), the second tube 111 can still serve to accommodate and protect the sensor 112.

[0054] In some examples, the length of the second tube 111 can be from 1 mm to 10 mm. For example, the length of the second tube 111 can be 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 8 mm, or 10 mm. Preferably, the length of the second tube 111 can be from 2 mm to 5 mm.

[0055] In some examples, the second tube 111 can be a rigid tube. For example, the second tube 111 can be made of stainless steel, metal alloy, or the like. This reduces the risk that the second tube 111 may deform due to excessive external pressure during operation (e.g., when passing through a highly curved blood vessel).

[0056] In some examples, the surface of the second tube 111 may be covered with a coating (not shown). In some examples, the coating may be biocompatible. This reduces the risk of damage to the lumen 2 from the second tube 111 while protecting the second tube 111.

[0057] See in some examples Figure 3A or Figure 3B The second tube 111 may have a connecting hole 1111. In some examples, the connecting hole 1111 can be used to connect the first tube 12 and the second tube 111. In some examples, at least one end of the second tube 111 may have a connecting hole 1111. In some examples, the connecting hole 1111 can be at least one (…). Figure 3A and Figure 3B One of the connection holes 1111 is schematically identified, for example, one, two, four, or eight. In some examples, at least one end of the second tube 111 may have at least one connection hole 1111. In some examples, the connection hole 1111 may be a square hole.

[0058] See in some examples Figure 3A or Figure 3B The connecting holes 1111 can be evenly distributed at at least one end of the second tube 111. This allows for a more uniform force distribution at the connection between the first tube 12 and the second tube 111, thereby reducing the risk of disconnection due to excessive deformation of the first tube 12 and the second tube 111. In some examples, the connecting holes 1111 can be distributed in a circumferential manner at at least one end of the second tube 111, that is, the connecting holes 1111 can be distributed circumferentially along the second tube 111. In some examples, the connecting holes 1111 can also be distributed axially along the second tube 111 (see...). Figure 3B ).

[0059] In some examples, the second tube 111 may not have a connecting hole 1111. This facilitates the machining of the second tube 111.

[0060] See in some examples Figure 3A or Figure 3B The second tube 111 may include a main body 1112. In some examples, the second tube 111 may include a first end 1113. In some examples, the first end 1113 may be located at one end of the main body 1112. In some examples, the second tube 111 may include a second end 1114. In some examples, the second end 1114 may be located at one end of the main body 1112. In some examples, the first end 1113 and the second end 1114 may be located at both ends of the main body 1112 (see [reference]). Figure 3A or Figure 3B ).

[0061] Figure 4 This is a schematic diagram showing the internal structure of the sensor assembly 11 involved in the example of this disclosure.

[0062] In some examples, sensor component 11 may include sensor 112 (see Figure 4 In some examples, sensor 112 can measure parameters outside the second tube 111.

[0063] See in some examples Figure 4 The sensor 112 can be located inside the second tube 111. In this case, by placing the sensor 112 inside the second tube 111 to reduce the overall diameter of the second tube 111, the risk of an excessively large overall diameter can be reduced, thereby improving the passability of the measuring device 1 and reducing damage to the lumen 2.

[0064] See in some examples Figure 4 The sensor 112 can be located on the central axis of the second tube 111. This reduces the risk of collision between the sensor 112 and the second tube 111.

[0065] In some examples, there can be multiple sensors 112. In some examples, the sensors 112 can be arrayed along the axis of the measuring device 1. In this case, the measurement range of the measuring device 1 can be increased. In addition, since multiple parameters at multiple locations in the lumen 2 can be measured by pushing the measuring device 1 into the lumen 2 once, the number of pushes can be reduced compared to the scheme of directly placing multiple sensors 112 in a single catheter, which helps to improve diagnostic efficiency.

[0066] In some examples, the number of sensors 112 may be equal to the number of second tubes 111. In other words, there is one sensor 112 in one second tube 111. Alternatively, in some examples, there may be multiple sensors 112 in one second tube 111.

[0067] In some examples, the second tube 111 can be used to house and protect the sensor 112. In this case, the protection provided by the second tube 111 reduces the risk that the sensor 112 may be damaged by excessive external pressure during operation (e.g., when passing through a large, tortuous blood vessel), thereby helping to improve the measurement stability of the measuring device 1.

[0068] In some examples, sensor 112 can be any one of a temperature sensor, pressure sensor, blood flow sensor, blood oxygen saturation sensor, and ultrasonic transducer.

[0069] As described above, the sensors 112 in the plurality of sensor assemblies 11 can each operate independently. In some examples, the sensors 112 in the plurality of sensor assemblies 11 can each be independently selected from any one of a temperature sensor, a pressure sensor, a blood flow sensor, a blood oxygen saturation sensor, and an ultrasonic transducer. Thus, a suitable sensor 112 can be selected according to actual needs, expanding the applicability of the measuring device 1.

[0070] As described above, the measuring device 1 can enter the lumen 2. In some examples, the health status of the patient 3 can be diagnosed using data from one or more sensors 112 on the measuring device 1. For ease of description, the following example uses two sensors 112, and the type of sensors 112 is a pressure sensor.

[0071] In some examples, the position of the main lesion area relative to sensor 112 can be determined based on data acquired by multiple sensors 112. In some examples, referencing... Figure 2 After the measuring device 1 is pushed to the target area A, data from the first sensor 112a and the second sensor 112b can be obtained. In some examples, the degree of lesion can be determined based on the magnitude of the data from the first sensor 112a and the second sensor 112b.

[0072] In some examples, sensor assembly 11 may include conductive portion 113 (see Figure 4 In some examples, sensor 112 can measure parameters (i.e., physiological parameters of the external environment) outside the second tube 111 via conductive part 113. In other words, conductive part 113 can transmit parameters outside the second tube 111 to sensor 112. Taking pressure as the parameter outside the second tube 111 and sensor 112 as a pressure sensor as an example, when conductive part 113 is subjected to pressure from outside the second tube 111, conductive part 113 can deform, thereby transmitting the pressure to sensor 112.

[0073] See in some examples Figure 4 The conductive part 113 may include an opening 1131. In some examples, the conductive part 113 may include an opening 1131 on the wall of the second tube 111. In other words, the opening 1131 may be located on the wall of the second tube 111. This facilitates the sensor 112 in measuring parameters outside the second tube 111.

[0074] In some examples, the orientation of the openings 1131 in multiple sensor assemblies 11 can be adjusted according to actual needs. Specifically, the orientations of the multiple openings 1131 can be the same or different. For example, when it is necessary to measure the areas on both sides of the measuring device 1, a measuring device 1 with multiple openings 1131 having different orientations can be selected. This allows the physiological parameters on both sides of the measuring device 1 to be measured without rotating the measuring device 1. By reducing the rotation frequency or angle of the measuring device 1, damage to the lumen 2 by the measuring device 1 can be reduced.

[0075] See in some examples Figure 4 Within the second tube 111, the position of the sensor 112 can correspond to the position of the opening 1131. For example, the axial position of the sensor 112 in the second tube 111 can be the same as the axial position of the opening 1131 in the second tube 111. This allows the sensor 112 to easily measure external parameters of the second tube 111 through the opening 1131.

[0076] In some examples, the length of the opening 1131 along the axial direction of the second tube 111 can be greater than the length of the sensor 112. This reduces the obstruction of the second tube 111 to the measurement of the sensor 112, thereby improving the measurement accuracy of the measuring device 1.

[0077] In some examples, the length of the opening 1131 along the axial direction of the second tube 111 can be less than the length of the sensor 112. This reduces the risk of the sensor 112 falling out of the second tube 111 from the opening 1131 during operation of the measuring device 1.

[0078] See in some examples Figure 4 The conductive portion 113 may include a conductive layer 1132. In some examples, the conductive layer 1132 may cover the opening 1131. In this case, by having the conductive layer 1132 cover the opening 1131, the influence of the external environment of the second tube 111 on the measurement of the sensor 112 can be reduced. For example, when the measuring device 1 is placed in a blood vessel for measurement, the possibility of blood entering the second tube 111 can be reduced.

[0079] In some examples, the stiffness of the conductive layer 1132 may be less than the stiffness of the second tube 111. In this case, by setting the conductive layer 1132 to have lower stiffness, it is possible for the sensor 112 located inside the second tube 111 to measure parameters outside the tube. For example, when the sensor 112 is a pressure sensor, the pressure sensor can accurately measure the pressure outside the tube through the deformation of the conductive layer 1132.

[0080] In some examples, the conductive layer 1132 may be made of a biocompatible material. For example, when the sensor 112 is a pressure sensor, the conductive layer 1132 may be made of silicone gel. It should be noted that for different types of sensors 112, the conductive layer 1132 may be made of different types of materials to reduce the impact of the conductive layer 1132 on the measurement accuracy of the sensor 112.

[0081] See in some examples Figure 4 The sensor assembly 11 may also include a wire 114. In some examples, the wire 114 may be connected to the sensor 112.

[0082] In some examples, the lead wire 114 can transmit data measured by the sensor 112 to an external body. In some examples, the lead wire 114 can extend outward. In some examples, the lead wire 114 can extend outward via the first tube 12 and the second tube 111. In this case, by connecting the lead wire 114 to the sensor 112 and extending it outward, it is convenient to acquire multiple physiological parameters measured by the measuring device 1.

[0083] In some examples, the wires 114 can be arranged in a straight line in the first tube 12 and the second tube 111. In other words, the wires 114 can be naturally straight in the first tube 12 and the second tube 111. In this case, by arranging the wires 114 of the multiple sensors 112 in an orderly manner in the first tube 12 and the second tube 111, the influence of the wires 114 on the installation and measurement of the sensors 112 can be reduced.

[0084] See in some examples Figure 4The measuring device 1 may include a core wire 115. In some examples, the core wire 115 may be used to support the measuring device 1. In some examples, the core wire 115 may be fixed (e.g., welded or bonded) to the inner wall of the second tube 111, excluding the opening 1131 of the conductive portion 113. In some examples, the core wire 115 may be a variable diameter core wire, specifically, the outer diameter of the core wire 115 may gradually increase from the distal end to the proximal end of the measuring device 1. This improves the passability of the measuring device 1 and reduces the risk of the core wire 115 breaking due to stress concentration. In some examples, the core wire 115 may be located inside the measuring device 1.

[0085] In some examples, the core wire 115 can be arranged in a straight line within the measuring device 1. In this case, by reducing the twisting or rotation of the core wire 115, the risk of the core wire 115 breaking due to twisting or rotation can be reduced. In addition, it facilitates the assembly of the core wire 115 into the measuring device 1.

[0086] In some examples, the core wire 115 can be arranged in a spiral shape within the measuring device 1. In this case, by making the core wire 115 resemble a spring, the radial support of the core wire 115 to the measuring device 1 can be improved.

[0087] In some examples, the core wire 115 can be set as one segment or multiple segments. Taking the core wire 115 as a straight line in the measuring device 1 as an example, when the multiple openings 1131 have the same orientation, the core wire 115 can be set as one segment; when the multiple openings 1131 have different orientations, there is a risk that the core wire 115 may block the openings 1131 if the core wire 115 is only one segment. In this case, the core wire 115 can be set as multiple segments, so that the position of each segment of the core wire 115 in the measuring device 1 can be adjusted independently to make each segment of the core wire 115 avoid the openings 1131.

[0088] In some examples, the core wire 115 can be made of a metallic material. In this case, supporting the first tube 12 and the second tube 111 with the core wire 115 can improve the passability of the measuring device 1.

[0089] See in some examples Figure 4 The sensor assembly 11 may also include a fixing part 116. In some examples, the fixing part 116 may be configured to fix the sensor 112. This can suppress unwanted movement of the sensor 112, thereby improving the measurement stability of the measuring device 1.

[0090] In some examples, the sensor 112 can be fixed at a position that contacts the conductive portion 113. This facilitates measurement by the sensor 112 through the conductive portion 113. In some examples, the sensor 112 can be fixed at a position that maintains contact with the conductive portion 113 by the fixing portion 116.

[0091] See in some examples Figure 4 The fixing part 116 can be configured to fix the sensor 112 at a position in contact with the conductive part 113. In this case, fixing the sensor 112 at the position in contact with the conductive part 113 by the fixing part 116 can help the sensor 112 to perform measurements through the conductive part 113, and the fixing part 116 can suppress unwanted movement of the sensor 112, thereby improving the measurement stability of the measuring device 1.

[0092] In some examples, the sensor 112 can be fixed by injecting adhesive into the second tube 111. In some examples, the fixing part 116 can be formed after the adhesive has solidified. In this case, since the measuring device 1 is relatively thin (i.e., has a small radial dimension), fixing the sensor 112 by injecting adhesive to form the fixing part 116 facilitates the assembly of the sensor 112. In addition, fixing the sensor 112 without additional fixing structures simplifies the processing of the second tube 111 and facilitates the miniaturization of the measuring device 1. In some examples, the adhesive may include glue.

[0093] In some examples, the fixing part 116 can also be a mechanical fixing structure, such as a slot. In some examples, the fixing part 116 can be integrally formed with the second tube body 111.

[0094] In some examples, the fixing part 116 can also be used to fix the wire 114 and the core wire 115. This reduces the swaying of the wire 114 and the core wire 115 within the second tube 111, thereby reducing the impact of the swaying of the wire 114 and the core wire 115 on the measurement of the sensor 112.

[0095] In some examples, see [reference] Figure 2 The measuring device 1 may include a first tube 12. In some examples, the first tube 12 may be a flexible tube. In this case, by providing the first tube 12, the overall flexibility of the measuring device 1 can be improved, thereby improving the passability of the measuring device 1. In some examples, the first tube 12 may be made of a polymer material. For example, the first tube 12 may be made of a polymer material such as PEBAX (polyether block polyamide) or PE (polyethylene).

[0096] In some examples, the first tube 12 can be cylindrical. This reduces the damage that the first tube 12 can cause to the lumen 2. In some examples, the first tube 12 can also be a rounded square. In some examples, the axial length of the first tube 12 can be greater than the axial length of the sensor assembly 11.

[0097] See in some examples Figure 2The sensor assembly 11 can be connected to the first tube 12. In this case, by connecting the sensor assembly 11 to the first tube 12, the sensor assembly 11 and the first tube 12 can be assembled, thereby facilitating the assembly of the measuring device 1. In some examples, the two ends of the sensor assembly 11 can be connected to two different first tubes 12.

[0098] See in some examples Figure 2 The sensor assembly 11 and the first tube 12 can be connected along the axial direction of the measuring device 1. In some examples, the sensor assembly 11 can be alternately connected to the first tube 12, that is, multiple sensor assemblies 11 and multiple first tubes 12 can be alternately connected in sequence.

[0099] In some examples, the connection between the sensor assembly 11 and the first tube 12 can be a fixed connection. In some examples, the sensor assembly 11 and the first tube 12 can be fixedly connected along the axial direction of the measuring device 1. For example, the sensor assembly 11 can be fixedly connected to the first tube 12 by means of sleeve connection, screw connection, bonding, and / or thermoforming welding. This helps to ensure a stable connection between the sensor assembly 11 and the first tube 12.

[0100] In some examples, the stiffness of at least a portion of the sensor assembly 11 may be greater than the stiffness of the first tube 12. In some examples, among multiple sensor assemblies 11, two adjacent sensor assemblies 11 can be connected via the first tube 12. That is, two adjacent sensor assemblies 11 can be mechanically connected to the first tube 12 via their respective second tubes 111. In this case, since the stiffness of the second tube 111 of the sensor assembly 11 is greater than the stiffness of the first tube 12, connecting two adjacent sensor assemblies 11 via the first tube 12 can help establish a flexible connection between the two adjacent sensor assemblies 11, thereby facilitating the passage of the two adjacent sensor assemblies 1 through complex lesion areas and improving the passability of the measuring device 1.

[0101] Figure 5A It shows Figure 3A A schematic diagram of the connection between the second tube 111 and the first tube 12. Figure 5B It shows Figure 3B A schematic diagram of the connection between the second tube 111 and the first tube 12. It should be noted that... Figure 5A and Figure 5B In this illustration, only the first end 1113 is shown for clarity, but it should not be construed as a limitation of this disclosure. The same description applies to the second end 1114 as well.

[0102] See in some examples Figure 5A or Figure 5BThe second tube 111 can be connected to the first tube 12. In some examples, the second tube 111 can be fixedly connected to the first tube 12.

[0103] In some examples, the connection between the second pipe body 111 and the first pipe body 12 can be at least one of the following: sleeve connection, screw connection, adhesive bonding, and thermofusion welding. In some examples, the second pipe body 111 and the first pipe body 12 can be fixedly connected by sleeve connection, screw connection, adhesive bonding, and / or thermofusion welding. In this case, sleeve connection, screw connection, adhesive bonding, and / or thermofusion welding can help to stably connect the first pipe body 12 and the second pipe body 111.

[0104] In some examples, the first tube 12 may be fitted over the second tube 111. In some examples, the first tube 12 may be fitted over the second tube 111 in a manner that covers the connection hole 1111. In some examples, the first tube 12 may be a flexible tube. For example, the first tube 12 may be made of a polymer material.

[0105] In some examples, at least a portion of the first tube 12 can be deformed by thermofusion welding. In some examples, at least a portion of the first tube 12 can be embedded in the connection hole 1111. In some examples, at least a portion of the first tube 12 can be deformed by thermofusion welding to embed in the connection hole 1111. In this case, deforming at least a portion of the first tube 12 by thermofusion welding to embed in the connection hole 1111 of the second tube 111 can further improve the stability of the fixed connection between the first tube 12 and the second tube 111.

[0106] See in some examples Figure 5A or Figure 5B The first tube 12 can be fitted over the second tube 111.

[0107] As described above, the radial dimensions of each part of the second tube 111 can be equal. In some examples, when the first tube 12 is made of a polymer material (i.e., the first tube 12 is elastic) and the outer diameter of the first tube 12 can be equal to the outer diameter of the second tube 111, the end of the first tube 12 connected to the second tube 111 can be deformed by manpower or tools to fit over the second tube 111. Thus, the elastic force after the first tube 12 is deformed can make the connection between the first tube 12 and the second tube 111 more stable.

[0108] As described above, the radial dimensions of the various parts of the second tube 111 may be unequal (for example, the outer diameter of at least one of the first end 1113 and the second end 1114 is smaller than the outer diameter of the main body 1112). In this case, since the first tube 12 has a certain thickness, by making the outer diameters of both ends of the second tube 111 smaller than the outer diameter of the main body 1112, it is possible to help align the outer peripheral surface of the first tube 12 with the outer peripheral surface of the second tube 111, thereby improving the smoothness of the connection between the first tube 12 and the second tube 111.

[0109] In some examples, the first tube 12 can also be embedded within the second tube 111. That is, the first tube 12 can be mechanically connected to the second tube 111 in a manner that allows it to be embedded within the second tube 111.

[0110] In some examples, the second tube 111 can have a similar shape to the first tube 12; for example, when the first tube 12 is cylindrical, the second tube 111 can also be cylindrical. This improves the smoothness of the connection between the first tube 12 and the second tube 111.

[0111] See in some examples Figure 5A or Figure 5B The second tube 111 can be coaxial with the first tube 12, for example, the second tube 111 can be aligned with the first tube 12. This reduces the outer diameter of the measuring device 1, thereby improving the passability of the measuring device 1.

[0112] In some examples, the outer diameter of the first tube 12 can be equal to the outer diameter of the second tube 111. This improves the smoothness of the connection between the first tube 12 and the second tube 111, thereby improving the passability of the measuring device 1 and reducing damage to the cavity 2. It should be noted that when the radial dimensions of different parts of the second tube 111 are not equal, the equality of the outer diameter of the first tube 12 with the outer diameter of the second tube 111 can mean that the outer diameter of the first tube 12 is equal to the outer diameter of the main body 1112 of the second tube 111.

[0113] In some examples, the stiffness of the second tube 111 can be greater than that of the first tube 12. In this case, the protection provided by the second tube 111 can improve the resistance of the sensor 112 to external forces, reduce the risk of the sensor 112 being damaged by excessive external pressure during operation (e.g., when passing through a large, tortuous blood vessel), and thus help improve the measurement stability of the measuring device 1.

[0114] In other examples, the stiffness of the second tube 111 may not be greater than the stiffness of the first tube 12. This improves the passability of the measuring device 1.

[0115] As described above, the second tube 111 may include a first end 1113 and a second end 1114. See also: [examples omitted] Figure 5A or Figure 5B At least one of the first end 1113 and the second end 1114 can be connected to the first tube 12. Specifically, at least one of the first end 1113 and the second end 1114 can be embedded in the first tube 12.

[0116] See in some examples Figure 5A The outer diameter of at least one of the first end portion 1113 and the second end portion 1114 may be equal to the outer diameter of the main body portion 1112.

[0117] See in some examples Figure 5B The outer diameter of at least one of the first end 1113 and the second end 1114 may be smaller than the outer diameter of the main body 1112. In this case, by making the outer diameter of the first end 1113 and / or the second end 1114 smaller than the outer diameter of the main body 1112, it is easier for the first end 1113 and / or the second end 1114 to be embedded in the first tube 12, thereby improving the stability and convenience of the connection between the first tube 12 and the second tube 111.

[0118] In some examples, the outer diameter of at least one of the first end 1113 and the second end 1114 may match the inner diameter of the first tube 12. In some examples, the outer diameter of at least one of the first end 1113 and the second end 1114 may be greater than or equal to the inner diameter of the first tube 12. For example, the first end 1113 and / or the second end 1114 may form an interference fit with the first tube 12. In this case, by matching the outer diameter of the first end 1113 and / or the second end 1114 with the inner diameter of the first tube 12, it is easier for the first end 1113 and / or the second end 1114 to be embedded inside the first tube 12 and to reduce the shaking of the first end 1113 and / or the second end 1114 within the first tube 12, thereby further improving the stability of the fixed connection between the first tube 12 and the second tube 111.

[0119] In some examples, the outer diameter of the first end 1113 and / or the second end 1114 can be equal to or less than the inner diameter of the first tube 12. This facilitates the connection between the first tube 12 and the second tube 111. In some examples, the outer diameter of the first end 1113 and / or the second end 1114 can be greater than the inner diameter of the first tube 12. This allows the first tube 12 and the second tube 111 to form an interference fit, thereby further improving the stability of the fixed connection between the first tube 12 and the second tube 111.

[0120] See in some examples Figure 5A or Figure 5BThe end of the second tube 111 may have a connection hole 1111 (for example, at least one of the first end 1113 and the second end 1114 has a connection hole 1111). In other words, the connection hole 1111 may be provided at the first end 1113 and / or the second end 1114.

[0121] See in some examples Figure 5A or Figure 5B The connecting holes 1111 can be evenly distributed at the first end 1113 and / or the second end 1114. This allows for a more uniform force distribution at the connection between the first tube 12 and the second tube 111, thereby reducing the risk of disconnection due to excessive deformation of the first tube 12, the first end 1113, and / or the second end 1114.

[0122] In some examples, the connecting holes 1111 may be distributed in a circumferential manner at the first end 1113 and / or the second end 1114, that is, the connecting holes 1111 may be distributed circumferentially along the first end 1113 and / or the second end 1114. In some examples, the connecting holes 1111 may also be distributed axially along the first end 1113 and / or the second end 1114 (see...). Figure 3B or Figure 5B ).

[0123] Figure 6A This is a schematic diagram showing the first tube 12 and the second tube 111 after thermal fusion welding according to the example of this disclosure. Figure 6B This is a schematic diagram showing the first tube 12 involved in the example of this disclosure flowing into the connection hole 1111 after hot-melt welding.

[0124] The following description uses the first embodiment of the second tube 111 as an example. As described above, at least a portion of the first tube 12 can be deformed by hot-melt welding. In some examples, when the first tube 12 is made of a polymer material, the first tube 12 can deform after hot-melt welding, for example, by flowing. In this case, after the first tube 12 cools and solidifies, the transition at the connection between the first tube 12 and the second tube 111 can be made more natural and smooth, thereby improving the passability of the measuring device 1. In addition, by hot-melt welding, the fit between the first tube 12 and the second tube 111 can be improved, thereby further improving the stability of the fixed connection between the first tube 12 and the second tube 111.

[0125] See in some examples Figure 6BAt least a portion of the first tube 12 can be embedded in the connection hole 1111. In some examples, at least a portion of the first tube 12 can be deformed (e.g., flowed) by thermoforming welding to embed in the connection hole 1111. Specifically, when the first tube 12 is fitted onto the second tube 111 and covers the connection hole 1111 of the second tube 111, the first tube 12 at the connection can be thermoformed, changing the first tube 12 from a solid state to a molten state so that it can flow into the connection hole 1111. Then, the first tube 12 is cooled, changing the first tube 12 from a molten state to a solid state and forming a protrusion that is embedded in the connection hole 1111. The protrusion of the first tube 12 is tightly embedded in the connection hole 1111 of the second tube 111, thereby forming a fixed connection between the first tube 12 and the second tube 111. In this case, by deforming at least a portion of the first tube 12 through hot-melt welding to embed it into the connection hole 1111 of the second tube 111, the stability and firmness of the fixed connection between the first tube 12 and the second tube 111 can be further improved.

[0126] In other examples, the connecting hole 1111 may be located on the first tube 12, and the second tube 111 may be heat-fused to embed the second tube 111 into the connecting hole 1111 of the first tube 12 and form a protrusion. The protrusion of the second tube 111 fits tightly with the connecting hole 1111 of the first tube 12 to fix the first tube 12 and the second tube 111 in place.

[0127] Figure 7 This is a schematic diagram illustrating the structure of the tip component 13 involved in the example of this disclosure.

[0128] See in some examples Figure 2 and Figure 7 The measuring device 1 may include a tip assembly 13 for positioning. In some examples, the tip assembly 13 may be located at the distal end of the measuring device 1.

[0129] See in some examples Figure 7 The tip component 13 may include a imaging member 131. In some examples, the imaging member 131 may include an imaging ring 1311 and a third tube 1312. In some examples, the imaging ring 1311 covers the outer surface of the third tube 1312. In some examples, the imaging ring 1311 can be used to position the measuring device 1. In some examples, after the measuring device 1 is inserted into the lumen 2, the position of the distal end of the measuring device 1 in the lumen 2 can be obtained through the imaging member 131. This facilitates the acquisition of the location of the lesion area.

[0130] In some examples, the third tube 1312 can be a flexible tube. This improves the passability of the measuring device 1. In some examples, the third tube 1312 can be a polymer tube, such as a tungsten powder tube.

[0131] See in some examples Figure 7 The tip assembly 13 may include an exchange member 132. In some examples, the exchange member 132 may include an outer tube 1321 and an inner tube 1322. In some examples, the outer tube 1321 may overlap with the inner tube 1322, and the outer tube 1321 may be heat-shrinkably fitted onto the inner tube 1322. In some examples, an exchange port 1323 may be formed at the overlap of the outer tube 1321 and the inner tube 1322 by beveling. In some examples, a guide wire (not shown) guiding the measuring device 1 into the lumen 2 may pass through the imaging member 131 and exit through the exchange port 1323.

[0132] In some examples, the developing member 131 may be fixed (e.g., welded or bonded) to the exchange member 132. In some examples, the exchange member 132 may be connected to the first tube 12, for example, the outer tube 1321 of the exchange member 132 may be fitted over the first tube 12.

[0133] In some examples, the measuring device 1 may include a support tube (not shown). In some examples, the support tube can be used to support the wound of the patient 3. In some examples, the support tube may be located at the proximal end of the measuring device 1. In some examples, the support tube may be made of a rigid material, such as a rigid medical plastic tube. This reduces the risk of wound collapse in the patient 3, thereby facilitating the operator's manipulation of the measuring device 1. Furthermore, the support tube improves the support of the measuring device 1, making it easier to push the measuring device 1 deeper into the lumen 2.

[0134] In some examples, the outer diameter of the support tube may be larger than the outer diameter of the sensor assembly 11 and the first tube 12. In some examples, the wire 114 and the core wire 115 may extend from the support tube. In some examples, the wire 114 and the core wire 115 may be fixed (e.g., welded or bonded) to the support tube.

[0135] In some examples, the support tube can be of constant diameter. This facilitates the fabrication of the support tube. In other examples, the support tube can be of variable diameter. This optimizes the stress distribution within the support tube, thereby facilitating the movement of the measuring device 1.

[0136] In some examples, the measuring device 1 may include a transition tube (not shown) for connecting the support tube body to the sensor assembly 11 or the first tube body 12. In some examples, the transition tube may be a flexible tube body with a variable diameter. In this case, since the outer diameter of the support tube body is larger than the outer diameter of the sensor assembly 11 and the first tube body 12, the transition tube can improve the stability of the connection between the support tube body and the sensor assembly 11 and / or the first tube body 12 by covering and connecting the support tube body to the sensor assembly 11 and / or the first tube body 12.

[0137] Figure 8 This is a flowchart illustrating the assembly method of the measuring device 1 involved in the example of this disclosure.

[0138] See in some examples Figure 8 The assembly method of the measuring device 1 may include: connecting the first tube 12 and the second tube 111 (step S100); inserting the sensor 112 into the second tube 111 and fixing the sensor 112 inside the second tube 111 (step S200).

[0139] Taking two first tubes 12, two second tubes 111, and two sensors 112 as an example, in steps S100 and S200, the first first tube 12 and the first second tube 111 can be connected first, then the first sensor 112 can be inserted into the first second tube 111 and fixed. Next, the second first tube 12 and the second second tube 111 can be connected, the second sensor 112 can be inserted into the second second tube 111 and fixed. This process can be repeated for cases with two or more first tubes 12, second tubes 111, and sensors 112. This facilitates the assembly of the sensors 112 into the measuring device 1 and allows for easy adjustment of the position, type, and number of the sensors 112. In some examples, the order of steps S100 and S200 can be reversed.

[0140] In some examples, preferably, the measuring device 1 includes a plurality of sensor assemblies 11 and a first tube 12. The sensor assembly 11 includes a second tube 111, a sensor 112 located inside the second tube 111, and a conductive part 113. The sensor 112 measures parameters outside the second tube 111 via the conductive part 113. The sensor assembly 11 is fixedly connected to the first tube 12. The stiffness of the second tube 111 is greater than the stiffness of the first tube 12.

[0141] The sensor assembly 11 of the measuring device 1 involved in this disclosure is independent and can be assembled with the first tube 12. Compared with the solution of directly setting multiple sensors 112 in a single conduit, this disclosure facilitates the assembly of the measuring device 1 by setting an independent sensor assembly 11 including a second tube 111 and adjusting the position and number of sensor assemblies 11 in the measuring device 1 according to actual needs. In addition, setting the sensor 112 in the second tube 111, which has greater rigidity, can reduce the risk of the overall diameter of the second tube 111 being too large. On the other hand, the protection of the second tube 111 can improve the resistance of the sensor 112 to external forces, reducing the risk of the sensor 112 being damaged by excessive external pressure during operation (e.g., when passing through a large, tortuous blood vessel), thereby helping to improve the measurement stability of the measuring device 1.

[0142] In summary, according to this disclosure, a measuring device 1 with high measurement stability and easy assembly can be provided.

[0143] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.

Claims

1. A measuring device, characterized in that, The device includes multiple sensor assemblies and a first tube. Each sensor assembly includes a second tube, a sensor located within the second tube, and a conductive portion. The sensor measures parameters outside the second tube via the conductive portion. The sensor assemblies are fixedly connected to the first tube along the axial direction of the measuring device. The second tube has a higher stiffness than the first tube. The second tube and the first tube are fixedly connected by a sleeve connection and thermal fusion welding. At least one end of the second tube has at least one connection hole. The first tube is sleeved onto the second tube to cover the connection hole, and at least a portion of the first tube is deformed by thermal fusion welding to embed into the connection hole. The conductive portion transmits parameters from the outside of the second tube to the sensor. The conductive portion includes an opening in the wall of the second tube and a conductive layer covering the opening. The conductive layer is made of a biocompatible material. The sensor assembly further includes a fixing part located within the second tube, the fixing part being configured to fix the sensor at a position in contact with the conductive part.

2. The measuring device according to claim 1, characterized in that, In the plurality of sensor assemblies, two adjacent sensor assemblies are connected through the first tube.

3. The measuring device according to claim 1, characterized in that, The second tube includes a main body and a first end and a second end located at both ends of the main body, wherein the outer diameter of at least one of the first end and the second end is smaller than the outer diameter of the main body and matches the inner diameter of the first tube.

4. The measuring device according to claim 1, characterized in that, The outer diameter of the first tube is equal to the outer diameter of the second tube.

5. The measuring device according to claim 1, characterized in that, Each sensor in the plurality of sensor assemblies is independently selected from any one of a temperature sensor, a pressure sensor, a blood flow sensor, a blood oxygen saturation sensor, and an ultrasonic transducer.

6. The measuring device according to claim 1, characterized in that, The sensor assembly also includes a wire connected to the sensor, the wire extending outward through the first tube and the second tube.

Images