A tensile pressure measuring catheter

Abstract

The present invention discloses a tensile-resistant pressure measuring catheter, which comprises a force-bearing connecting member and a plurality of pressure measuring units connected in sequence. Each of the pressure measuring units comprises a connected sensor carrier and a hollow tube; one end of the force-bearing connecting member is connected to the sensor carrier, and the other end of the force-bearing connecting member is connected to another sensor carrier or a rigid force-bearing member. The technical problem solved by the present invention is to develop a tensile-resistant pressure measuring catheter with more accurate pressure measurement, higher integrity and connection reliability.

Description

Technical Field

[0001] The present invention relates to the technical field of high-resolution gastroesophageal manometry catheters, and particularly to a tensile-resistant manometry catheter. Background Art

[0002] Currently, gastroesophageal diseases are on the rise year by year. Conventional diagnostic techniques such as gastroscopy and gastrointestinal imaging can only detect most organic lesions of the gastroesophagus and some motility diseases, but for the vast majority of gastroesophageal motility disorders such as gastroesophageal reflux disease and achalasia, they cannot systematically, accurately, and intuitively describe and evaluate. High-resolution esophageal manometry (HRM) technology is often used for detection. The commonly used solid-state manometry catheters on the market are divided into two types: capacitive pressure sensors and resistive pressure sensors. Both have difficulties such as complex processes and high costs, and also have problems such as small manometry angles, poor accuracy, easy breakage, and narrow coverage.

[0003] At the same time, the human gastroesophageal tract has bending changes. Therefore, the manometry catheter needs to maintain a certain flexible bending performance. However, there is also a certain resistance when entering or exiting the gastroesophageal tract, and it also needs to withstand the pressure in the gastroesophageal tract. The manometry catheter also needs to have a certain integrity and connection reliability, and it is necessary to prevent the manometry catheter from being stretched and extended or even pulled and broken, so as to avoid inaccurate measurement and medical accidents.

[0004] Therefore, those skilled in the art are committed to developing a tensile-resistant manometry catheter with more accurate manometry, higher integrity, and connection reliability. Summary of the Invention

[0005] In view of the above-mentioned defects of the prior art, the present invention discloses a tensile-resistant manometry catheter, and the technical problem to be solved is to provide a tensile-resistant manometry catheter with more accurate manometry, higher integrity, and connection reliability.

[0006] To achieve the above object, the present invention provides a tensile-resistant manometry catheter, which includes a force-bearing connector and a plurality of sequentially connected manometry units. Each of the manometry units includes a connected sensor carrier and a hollow tube; one end of the force-bearing connector is connected to the sensor carrier, and the other end of the force-bearing connector is connected to another sensor carrier or a rigid force-bearing member.

[0007] Preferably, the sensor carrier is provided with a first through hole along the axis, and the rigid force-bearing member is provided with a second through hole along the axis.

[0008] Preferably, a rubber tube is connected to the tail ends of the connected plurality of pressure measuring units. The rubber tube is located outside the body during pressure measurement, and the other end of the rubber tube is connected to a transfer device. The rigid force-bearing member is arranged inside the transfer device or inside the rubber tube. In addition to being able to connect and fix two sensor carriers at both ends respectively, the force-bearing connecting member can also connect one end to a sensor carrier and the other end to the above-mentioned separate rigid force-bearing member, so that the rubber tube can also be partially or fully supported, improving the anti-pulling performance of the rubber tube.

[0009] Preferably, in order to be more convenient to insert into the natural body cavity, an insertion head is connected to the head ends of the connected plurality of pressure measuring units. The insertion head is closed at one end and has a connection head at the other end for cooperating with the sensor carrier. Specifically, the insertion head is a solid conical structure with a smooth transition at one end being closed. The connection head at the other end of the insertion head is connected to the sensor carrier of the first pressure measuring unit, and the first pressure measuring unit is then connected to the second pressure measuring unit, and so on until the Nth pressure measuring unit is connected. The other end of the last pressure measuring unit is connected to the rubber tube and then to the transfer device, and the transfer device is then connected to the data analysis device. The cable formed by the wires of the previous pressure measuring unit passes through the hollow tube in sequence and then passes through the hollow tube of the next pressure measuring unit until it passes out of the terminal pressure measuring unit and the hollow tube. Both the insertion head and the hollow tube are made of flexible materials, and the flexible materials are preferably polyethylene, polypropylene, polyamide, polyurethane, silica gel, etc.

[0010] Preferably, a connection hole is provided at one end of the sensor carrier, and a fixing hole is provided at one end of the rigid force-bearing member. Both the connection hole and the fixing hole can be used to fix the end of the force-bearing connecting member.

[0011] Preferably, the rigid force-bearing member includes a limiting ring, and connecting rings are arranged on both sides of the limiting ring. A second through hole is formed inside the limiting ring and the two connecting rings. Anti-slip convex rings are provided outside both of the connecting rings, and the fixing hole is provided on one of the connecting rings.

[0012] Preferably, the end of the force-bearing connecting member can be fixed on the inner wall of the first through hole or the second through hole.

[0013] The force-bearing connecting member can be connected to the connection hole of the sensor carrier or the fixing hole of the rigid force-bearing member by means of winding and binding; it can also be fixed on the inner wall of the first through hole of the sensor carrier or the inner wall of the second through hole of the rigid force-bearing member by means of adhesive fixation or welding fixation, etc.

[0014] Preferably, the force-bearing connecting member is a connecting line segment made of a material that can be bent, is anti-pulling, and has no elasticity. The length of the force-bearing connecting member is less than or equal to the natural length of the fixed pressure measuring unit, and its material is usually selected from wire harnesses or steel wires, etc.

[0015] Preferably, the sensor carrier includes a mounting portion, and both ends of the mounting portion are connecting portions. The mounting portion and the connecting portions have coaxially hollow first through holes. A receiving groove is provided on the mounting portion. The number of the receiving grooves is multiple, and the multiple receiving grooves are evenly distributed along the circumferential direction of the mounting portion. By increasing the number of the receiving grooves, the number of sensors can be increased, and pressure detection of the axial circumferential surface of 360° can be achieved. A lead hole and a ventilation hole are provided at the bottom of the receiving groove, and the wire of the pressure sensor passes through the lead hole into the through hole. In addition, the diameter of the mounting portion is larger than that of the connecting portion, and a protruding structure is provided outside the connecting portion. The mounting portions at both ends can be respectively inserted into bendable hollow tubes to form a connection and then be successively connected in series to the mounting portion of the next sensor carrier to form a pressure measuring catheter. The protruding structure is an annular protrusion, which can increase the friction force when connecting the hollow tubes, ensure the firmness of the connection, and prevent the sensor carrier from separating and falling off from the hollow tube.

[0016] Further, the pressure sensor in the present invention is a semiconductor resistive pressure sensor made of single crystal silicon. According to the piezoresistive effect of single crystal silicon, the strain resistance circuit on the elastic diaphragm of the pressure sensor generates a resistance change with mechanical deformation, and the strain signal is transmitted to the outside through the corresponding circuit of the sensor. One side of the elastic diaphragm of the pressure sensor communicates with a reference pressure (atmospheric pressure in this case) to form a reference, and the other side of the elastic diaphragm is an induction side for sensing pressure changes. After the pressure sensor is installed in the receiving groove, the induction side faces the outer circumferential surface of the sensor carrier, and the reference side faces the center of the circle. In this case, the bottom of the receiving groove corresponding to the reference side of the pressure sensor has at least one ventilation hole communicating with the atmosphere, which is convenient for the reference side to communicate with the atmosphere. The wire is usually an insulated cable, and each pressure sensor is directly electrically connected to one end of a group of independent wires or is connected through other conductive materials in a transfer manner. Each pressure sensor is connected with at least three wires.

[0017] Preferably, a soft sticky block is coated on the outer surface of the pressure sensor. The soft sticky block can not only be used as a medium to transfer the external pressure to make the pressure transfer more sensitive, but also protect the induction side outside the pressure sensor from external force damage, and can also protect the connection between the pressure sensor and the wire from being damaged. The soft sticky block is preferably a medical adhesive that meets biocompatibility requirements and is coated on the surface of the pressure sensor.

[0018] The beneficial effects of the present invention are:

[0019] The two ends of the force-bearing connecting member are respectively connected and fixed to the sensor carriers of at least two or more pressure measuring units of the pressure measuring catheter. The force-bearing connecting member is used to bear the tensile stress in the length direction of the pressure measuring catheter, so that the pressure measuring units within the connection and fixation range are restricted and cannot expand and extend when subjected to external tensile force, thereby playing a role in protecting the pressure measuring catheter, wires, etc. from being pulled and broken, and improving the integrity and connection reliability. At the same time, one end of the force-bearing connecting member can be connected to the sensor carrier, and the other end extends backward until the end of the pressure measuring unit or the rubber tube connected to the pressure measuring unit. By setting a rigid force-bearing member to fix the other end of the force-bearing connecting member, the overall connection reliability is further enhanced, avoiding overall elongation, and the integrity and connection reliability are higher. On the other hand, by setting the sensor carrier, the position of the pressure sensor can be fixed and the pressure sensor, etc. can be protected, making the pressure measurement result more accurate. Brief Description of the Drawings

[0020] Figure 1 is a schematic diagram of a partial external structure of the pressure measuring catheter of the present invention;

[0021] Figure 2 is a schematic diagram of a partial internal structure of the pressure measuring catheter of the present invention;

[0022] Figure 3 is a schematic diagram of the overall structure of the pressure measuring catheter of the present invention;

[0023] Figure 4 is a schematic diagram of the structure of the insertion head of the pressure measuring catheter of the present invention;

[0024] Figure 5 is a schematic diagram of the structure of the rigid force-bearing member of the pressure measuring catheter of the present invention;

[0025] Figure 6 is a schematic diagram of the structure of the sensor carrier of the pressure measuring catheter of the present invention;

[0026] Figure 7 is a schematic diagram of a partial cross-sectional view of the pressure measuring catheter of the present invention.

[0027] In the above-mentioned drawings: 1. Sensor carrier; 11. Mounting part; 111. Accommodating groove; 112. Lead hole; 113. Ventilation hole; 12. Connecting part; 121. Protruding structure; 122. Connecting hole; 13. First through hole; 2. Hollow tube; 3. Force-bearing connecting member; 4. Rigid force-bearing member; 41. Limiting ring; 42. Connecting ring; 421. Anti-slip convex ring; 43. Second through hole; 44. Fixing hole; 5. Rubber tube; 6. Transfer device; 7. Insertion head; 71. Connecting head; 8. Pressure sensor; 81. Wire. Detailed Description of the Invention

[0028] The present invention will be further described below in conjunction with the accompanying drawings and embodiments. It should be noted that in the description of the present invention, the orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific manner, and therefore cannot be construed as a limitation on the present invention. The terms "first", "second", "third", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0029] As Figure 1 and Figure 2 shown, the present invention provides a tensile-resistant pressure measuring catheter, which includes a force-bearing connector 3 and a plurality of pressure measuring units connected in sequence. Each pressure measuring unit includes a connected sensor carrier 1 and a hollow tube 2; one end of the force-bearing connector 3 is connected to the sensor carrier 1, and the other end of the force-bearing connector 3 is connected to another sensor carrier 1 or a rigid force-bearing member 4. The force-bearing connector 3 is a connecting line segment made of a bendable, tensile-resistant, and non-elastic material, and the length of the force-bearing connector 3 is less than or equal to the natural length of the fixed pressure measuring unit. Its material is usually selected from wire harnesses or steel wires, etc.

[0030] As Figure 3 shown, a rubber tube 5 is connected to the tails of a plurality of connected pressure measuring units. The rubber tube 5 is located outside the body during pressure measurement. The other end of the rubber tube 5 is connected to a transfer device 6, and the rigid force-bearing member 4 is arranged inside the transfer device 6 or inside the rubber tube 5. In addition to being able to connect and fix two sensor carriers 1 at both ends respectively, the force-bearing connector 3 can also connect one end to the sensor carrier 1 and the other end to the above-mentioned separate rigid force-bearing member 4, so that the rubber tube 5 can also be partially or fully supported, improving the tensile resistance of the rubber tube 5.

[0031] At the same time, in order to be more convenient to insert into the natural cavity of the human body, an insertion head 7 is connected to the heads of a plurality of connected pressure measuring units. As shown in 4, the insertion head 7 has one end closed and the other end is a connection head 71 that cooperates with the sensor carrier 1. Specifically, the insertion head 7 is a solid conical structure with a smooth transition at one end closed. The connection head 71 at the other end of the insertion head 7 is connected to the sensor carrier 1 of the first pressure measuring unit, and the first pressure measuring unit is then connected to the second pressure measuring unit, and so on, until the Nth pressure measuring unit is connected. The other end of the last pressure measuring unit is connected to the rubber tube 5 and then connected to the transfer device 6, and the transfer device 6 is then connected to the data analysis device. The cable formed by the wires 81 of the previous pressure measuring unit passes through the hollow tube 2 in sequence and then passes through the hollow tube 2 of the next pressure measuring unit until it passes through the hollow tube 2 of the last pressure measuring unit at the end. Both the insertion head 7 and the hollow tube 2 are made of flexible materials, and the flexible materials are preferably polyethylene, polypropylene, polyamide, polyurethane, silicone, etc.

[0032] As Figure 5 and Figure 6 shown, the sensor carrier 1 is provided with a first through hole 13 along the axial direction, and the rigid force-bearing member 4 is provided with a second through hole 43 along the axial direction. In the first implementation mode, the end of the force-bearing connecting member 3 can be fixed on the inner wall of the first through hole 13 or the second through hole 43; in another implementation mode, a connecting hole 122 is opened at one end of the sensor carrier 1, and a fixing hole 44 is opened at one end of the rigid force-bearing member 4. Both the connecting hole 122 and the fixing hole 44 can be used to fix the end of the force-bearing connecting member 3.

[0033] Specifically, as Figure 5 shown, the rigid force-bearing member 4 includes a limiting ring 41. When connecting, the two side surfaces of the limiting ring 41 abut against the end faces of the rubber hose 5, playing a role of limiting and sealing. On both sides of the limiting ring 41 are connecting rings 42. Inside the limiting ring 41 and the two connecting rings 42 is the second through hole 43. Anti-slip convex rings 421 are provided outside both of the two connecting rings 42. The anti-slip convex rings 421 play a role of preventing detachment when the connecting rings 42 are connected to the end of the rubber hose 5. A fixing hole 44 is opened on one of the connecting rings 42.

[0034] As Figure 6 and Figure 7 shown, the sensor carrier 1 includes a mounting portion 11. The two ends of the mounting portion 11 are connecting portions 12. The mounting portion 11 and the connecting portions 12 have a coaxial hollow first through hole 13. The mounting portion 11 is provided with receiving grooves 111. The number of the receiving grooves 111 is multiple, and the multiple receiving grooves 111 are evenly distributed along the circumferential direction of the mounting portion 11. By increasing the number of the receiving grooves 111, the number of sensors is increased, and pressure detection of the 360° axial circumferential surface can be realized. A lead hole 112 and a ventilation hole 113 are provided at the bottom of the receiving groove 111. The wire 81 of the pressure sensor 8 passes through the lead hole 112 and penetrates into the through hole. In addition, the diameter of the mounting portion 11 is larger than that of the connecting portion 12, and a protruding structure 121 is provided outside the connecting portion 12. The mounting portions 11 at both ends can be respectively inserted into the bendable hollow tubes 2 to form a connection and then be successively connected in series to the mounting portion 11 of the next sensor carrier 1 to form a pressure measuring conduit. The protruding structure 121 is an annular protrusion, which can increase the friction force when connecting the hollow tubes 2, ensure the firmness of the connection, and prevent the sensor carrier 1 from separating and falling off from the hollow tubes 2.

[0035] In the above two implementation modes, the force-bearing connecting member 3 can be connected to the connecting hole 122 of the sensor carrier 1 or the fixing hole 44 of the rigid force-bearing member 4 by means of winding and bundling; it can also be fixed on the inner wall of the first through hole 13 of the sensor carrier 1 or the inner wall of the second through hole 43 of the rigid force-bearing member 4 by means of adhesive fixation or welding fixation, etc.

[0036] Furthermore, the pressure sensor 8 in the present invention is a semiconductor resistive pressure sensor 8 made of single-crystalline silicon. According to the piezoresistive effect of single-crystalline silicon, the strain resistance circuit on the elastic diaphragm of the pressure sensor 8 generates a resistance change with mechanical deformation, and transmits the strain signal to the outside through the corresponding circuit of the sensor. One side of the elastic diaphragm of the pressure sensor 8 communicates with the reference pressure (atmospheric pressure in this case) to form a reference, and the other side of the elastic diaphragm is the sensing side for sensing pressure changes. After the pressure sensor 8 is installed in the accommodation groove 111, the sensing side faces the outer circumferential surface of the sensor carrier 1, and the reference side faces the center of the circle. In this case, the bottom of the accommodation groove 111 at the corresponding position of the reference side of the pressure sensor 8 has a vent hole 113 communicating with the atmosphere, and the number of vent holes 113 is at least one, facilitating the communication between the reference side and the atmosphere. The wire 81 is usually an insulated cable, and each pressure sensor 8 is directly electrically connected to one end of a group of independent wires 81 or connected through other conductive materials for transfer. Each pressure sensor 8 is connected to at least three wires 81.

[0037] In addition, the outer surface of the pressure sensor 8 is coated with a soft sticky block. The soft sticky block can not only be used as a medium to transfer external pressure, making the pressure transfer more sensitive, but also protect the sensing side outside the pressure sensor 8 from external force damage, and can also protect the connection between the pressure sensor 8 and the wire 81 from being damaged. The soft sticky block is preferably a medical adhesive that meets biocompatibility requirements and is coated on the surface of the pressure sensor 8.

[0038] In the above embodiments, the two ends of the force-bearing connector 3 are respectively connected and fixed to the sensor carriers 1 of at least two or more pressure-measuring units of the pressure-measuring catheter. The force-bearing connector 3 is used to bear the tensile stress in the length direction of the pressure-measuring catheter, so that the pressure-measuring units within the connection and fixation range are restricted and cannot expand and extend when subjected to external tensile force, thereby playing a role in protecting the pressure-measuring catheter and the wire 81 from being pulled and broken, and improving the integrity and connection reliability. At the same time, one end of the force-bearing connector 3 can be connected to the sensor carrier 1, and the other end extends backward until the end of the pressure-measuring unit or the rubber tube 5 connected to the pressure-measuring unit. By setting the rigid force-bearing member 4 to fix the other end of the force-bearing connector 3, the overall connection reliability is further enhanced, avoiding overall elongation, and the integrity and connection reliability are higher. On the other hand, by setting the sensor carrier 1, the position of the pressure sensor 8 can be fixed, and the pressure sensor 8 and the like can be protected, making the pressure measurement result more accurate.

[0039] Therefore, the pressure-measuring catheter of the present invention has the following advantages:

[0040] 1) Simple structure, accurate measurement, and high reliability: The pressure signal is measured by a resistive pressure sensor. Compared with the existing methods of feedback pressure such as water perfusion, the signal feedback is more accurate. At the same time, the main body of the pressure measurement catheter is a pressure sensor, which requires fewer supporting parts, has a simple structure, and high reliability.

[0041] 2) Reliable connection: After adding force-bearing connectors to the connection between pressure measurement units, it can avoid the overall and local elongation of the catheter, and problems such as catheter loosening and internal signal cable breakage.

[0042] 3) Reduce the defective rate and improve the first-pass yield of products: It avoids problems such as unreliable connection and wire breakage caused by the elongation of the pressure measurement catheter during the pulling in the production process, can reduce the defective rate in the production process, improve the first-pass yield of products, and reduce production costs.

[0043] The preferred specific embodiments of the present invention have been described in detail above. It should be understood that those of ordinary skill in the art can make many modifications and variations based on the concept of the present invention without creative labor. Therefore, all technical solutions that can be obtained by those skilled in the art in the technical field according to the concept of the present invention through logical analysis, reasoning, or limited experiments on the basis of the prior art should be within the protection scope determined by the claims.

Claims

1. A tensile pressure measuring catheter, characterized in that: It includes a force-bearing connecting member (3) and a number of pressure-measuring units connected in sequence. Each of the pressure-measuring units includes a connected sensor carrier (1) and a hollow tube (2); one end of the force-bearing connecting member (3) is connected to the sensor carrier (1), and the other end of the force-bearing connecting member (3) is connected to another sensor carrier (1) or to a rigid force-bearing member (4). The force-bearing connecting member (3) is a connecting line segment made of a bendable, tensile-resistant, and inelastic material, and the length of the force-bearing connecting member (3) is less than or equal to the natural length of the fixed pressure-measuring unit.

2. The tensile pressure measuring catheter according to claim 1, characterized in that: The sensor carrier (1) is provided with a first through hole (13) along the axis, and the rigid force-bearing member (4) is provided with a second through hole (43) along the axis.

3. The tensile pressure measuring catheter according to claim 1, characterized in that: The ends of the connected number of pressure-measuring units are connected to a rubber tube (5), the other end of the rubber tube (5) is connected to a transfer device (6), and the rigid force-bearing member (4) is arranged inside the transfer device (6) or inside the rubber tube (5).

4. The tensile pressure measuring catheter according to claim 3, characterized in that: The heads of the connected number of pressure-measuring units are connected to an insertion head (7), and the insertion head (7) has one end closed and the other end is a connection head (71) that mates with the sensor carrier (1).

5. The tensile pressure measuring catheter according to claim 3, characterized in that: One end of the sensor carrier (1) is provided with a connection hole (122), and one end of the rigid force-bearing member (4) is provided with a fixing hole (44). Both the connection hole (122) and the fixing hole (44) can be used to fix the end of the force-bearing connecting member (3).

6. The tensile pressure measuring catheter according to claim 5, wherein: The rigid force-bearing member (4) includes a limiting ring (41), both sides of the limiting ring (41) are connecting rings (42), the second through hole (43) is inside the limiting ring (41) and the two connecting rings (42), and anti-slip convex rings (421) are provided outside both of the connecting rings (42). The fixing hole (44) is opened on one of the connecting rings (42).

7. The tensile pressure measuring catheter according to claim 2, wherein: The end of the force-bearing connecting member (3) can be fixed on the inner wall of the first through hole (13) or the second through hole (43).

8. The tensile pressure measuring catheter according to claim 1, characterized in that: The outer side surface of the sensor carrier (1) is provided with a receiving groove (111), a lead hole (112) is provided at the bottom of the receiving groove (111), and a pressure sensor (8) is installed inside the receiving groove (111).

9. The tensile pressure measuring catheter according to claim 8, wherein: The outer surface of the pressure sensor (8) is coated with a soft sticky block.

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