Impedance detection catheter, impedance detection system, and impedance detection method

Abstract

The application provides an impedance detection catheter, an impedance detection system and an impedance detection method, and the impedance detection catheter comprises: a sheath tube, the sheath tube has a first lumen; a plurality of probe assemblies, each probe assembly comprises a lead wire and a probe which are connected with each other, the lead wire is used for being connected with an output end of a detection host, and the lead wire is arranged in the first lumen; wherein the probe of at least part of the probe assemblies has a liquid suction cavity and a liquid suction port which are communicated with each other; the probe assembly further comprises a suction tube, the suction tube is communicated with the liquid suction cavity, so that the liquid at a lesion position is sucked through the suction tube and the liquid suction cavity. The impedance detection catheter provided by the application solves the problem that the detection result is inaccurate in the prior art.

Description

Technical Field

[0001] This invention relates to the field of bioimpedance, and more specifically, to an impedance detection catheter, an impedance detection system, and an impedance detection method. Background Technology

[0002] Medical electrical impedance tomography (MET), also known as bioimpedance or simply impedance technology, is a non-invasive detection technique that utilizes the electrical properties (impedance, admittance, dielectric constant, etc.) of biological tissues and organs and their changes to extract biomedical information related to human physiological and pathological conditions. Research on MET began in the late 19th and early 20th centuries.

[0003] Currently, medical electrical impedance tomography (EIT) typically involves applying a small alternating current or voltage to the subject using an electrode system placed on the body surface. The EIT is then measured to detect the corresponding electrical impedance and its changes, and relevant physiological and pathological information is obtained depending on the application. This technique or method is non-invasive, inexpensive, safe, non-toxic, simple to operate, and provides abundant information, making it easily acceptable to doctors and patients and possessing broad application prospects.

[0004] Bioelectrical impedance analysis (BIA) technology can be used to obtain various electrical parameters within biological tissues. Through parameter analysis, it is possible to estimate the rate of cell metabolism, diagnose tissue function, detect edema, and diagnose tumor tissue.

[0005] However, the impedance detection catheter in the prior art is prone to displacement during detection, which can lead to detection interruption or inaccurate results. Summary of the Invention

[0006] The main objective of this invention is to provide an impedance detection catheter, an impedance detection system, and an impedance detection method to solve the problem that impedance detection catheters in the prior art are prone to inaccurate detection results.

[0007] To achieve the above objectives, the present invention provides an impedance detection catheter, comprising: a sheath having a first lumen; a plurality of probe assemblies, each probe assembly including interconnected wires and probes, the wires being used to connect to the output end of a detection host, the wires passing through the first lumen; wherein, at least some of the probe assemblies have probes having interconnected suction chambers and suction ports; the probe assembly further includes an aspiration tube communicating with the suction chambers to aspirate fluid from the lesion site through the aspiration tube and the suction chambers.

[0008] Furthermore, the end of the probe is a straight tube section, and the suction port is located on the end face of the straight tube section; or, the end of the probe is a bent tube section, and the suction port is located on the tube wall of the bent tube section.

[0009] Furthermore, when the suction port is located on the end face of the straight tube section, the end face of the straight tube section is inclined to the axis of the sheath tube so that the suction port is inclined to the axis of the sheath tube and faces the axis of the sheath tube; when the end of the probe is a bent tube section, the suction port is inclined to the axis of the sheath tube and faces the axis of the sheath tube.

[0010] Furthermore, when the end of the probe is a bent tube section, the probe also includes a first straight tube section and a second straight tube section. The two ends of the bent tube section are connected to the first straight tube section and the second straight tube section respectively. The second straight tube section is located outside the sheath. The end of the second straight tube section has an opening that communicates with the outside of the sheath so that some of the liquid inside the cavity wall can be drawn through the opening.

[0011] Furthermore, the impedance detection catheter also includes: an insulating base, a portion of which is inserted into the sheath, and multiple probe assemblies passing through the insulating base; wherein, multiple limiting grooves are formed on the outer peripheral wall of the insulating base located outside the sheath, and the probes of each probe assembly are bent after passing through the insulating base to form a bent section, and the suction port is set on the bent section, with at least a portion of the bent section located within the limiting grooves.

[0012] Furthermore, the bend includes a second straight section and a bent section connected to each other, with the suction port disposed on the bent section, and at least a portion of the second straight section located within a limiting groove; along the extension direction of the sheath, the length of the limiting groove is greater than the length of the second straight section; and / or, the insulating base has a first base section located outside the sheath, with the limiting groove located on the outer peripheral wall of the first base section, and the outer diameter of the first base section being equal to the outer diameter of the sheath, so that the first base section abuts against the end of the sheath.

[0013] Furthermore, the limiting groove has a groove opening along the radial direction of the second straight pipe section, at least a portion of the second straight pipe section being located outside the groove opening; wherein the limiting groove extends radially along the sheath so that the groove opening is located at the edge of the sheath.

[0014] Furthermore, the impedance detection conduit also includes: a stop block, which is fixed inside the sheath, and a probe is movably inserted through the stop block; and a buffer, one end of which is connected to the stop block and the other end of which is connected to the probe, so as to press or release the buffer during the movement of the probe.

[0015] Furthermore, there are multiple buffers, which are sleeved on the probes, and the multiple buffers are arranged one-to-one with the probes of the multiple probe assemblies; and / or, the probe includes a probe body and a stop portion, and the suction port is arranged on the probe body; the stop portion protrudes from the outer peripheral surface of the probe body and is fixedly arranged relative to the probe body to limit the buffer, the buffer is located between the stop portion and the stop block, and both ends of the buffer are connected to the stop portion and the stop block respectively; and / or, the impedance detection conduit also includes an insulating base, which is sleeved on the outside of the buffer and the multiple probe assemblies, and the insulating base abuts against the end face of the stop block on the side away from the suction tube.

[0016] Furthermore, the probes of the multiple probe assemblies each have a suction chamber and a suction port; the suction tube includes a main suction tube and multiple suction branch tubes, and the multiple suction branch tubes are connected to the probes of the multiple probe assemblies one-to-one, and the multiple suction branch tubes are all connected to the main suction tube.

[0017] Furthermore, the probe assembly also includes multiple wire fixing tubes, each wire fixing tube being sleeved on the corresponding probe and wire through its lumen, with the conductive parts of the probe and wire in contact, the probe and the inner wall of the wire fixing tube being press-fitted, and the conductive part of the wire and the inner wall of the wire fixing tube being press-fitted; and / or the aspiration tube is inserted into the probe to communicate with the aspiration chamber, with the aspiration tube and the probe being press-fitted.

[0018] Furthermore, the impedance detection conduit also includes: an aspiration connection tube and an aspiration connector, wherein the aspiration tube is connected to the aspiration connector via the aspiration connection tube; a connector connection tube and a detection connector, wherein one end of the lead wire passes through the sheath tube, passes through the connector connection tube, and is connected to the detection connector; and a handle assembly, wherein the end of the sheath tube furthest from the probe is mounted on the handle assembly, and both the aspiration connection tube and the connector connection tube are mounted on the handle assembly.

[0019] Furthermore, the impedance detection catheter also includes: a fitting component disposed on the sheath, at least a portion of which is telescopically disposed in a direction away from the outer peripheral surface of the sheath, such that the fitting component has an expanded state for fitting against the inner wall of the cavity and a contracted state for avoiding the inner wall of the cavity.

[0020] Furthermore, the sheath has an airway cavity, and the fitting assembly includes an airbag component that communicates with the airway cavity to ventilate the airbag component through the airway cavity; wherein the airway cavity and the first lumen are spaced apart; or, the fitting assembly includes a fitting component, the sheath includes a first sheath segment and a second sheath segment spaced apart, the fitting component includes a first connecting portion, a plurality of support bars and a second connecting portion connected in sequence, at least a portion of each support bar is located between the first sheath segment and the second sheath segment, the plurality of support bars are spaced apart around the sheath, the second connecting portion is fixedly connected to the second sheath segment, the first connecting portion is fixedly connected to the first sheath segment, and the first sheath segment or the second sheath segment is movably arranged to drive the first connecting portion or the second connecting portion to move, so that the plurality of support bars are telescopically arranged in a direction close to or away from the axis of the sheath.

[0021] Furthermore, the impedance detection catheter also includes: a cell brush assembly, which is inserted through the sheath, and multiple probe assemblies are arranged at intervals around the cell brush assembly; wherein the cell brush assembly is telescopically arranged along the extension direction of the sheath to have a sampling state that at least partially protrudes from the probe arrangement, so as to brush tissue samples through the cell brush assembly.

[0022] Furthermore, the impedance detection catheter also includes a radiopaque ring, which is disposed on the sheath and located outside the probe.

[0023] According to a second aspect of the present invention, an impedance detection system is provided, comprising: the impedance detection catheter described above; a detection host, wherein the probe assembly of the impedance detection catheter is connected to the detection host; and a negative pressure suction device, wherein the suction connector of the impedance detection catheter is connected to the negative pressure suction device.

[0024] According to a third aspect of the present invention, an impedance detection method is provided, applicable to the aforementioned impedance detection catheter. The impedance detection method includes: inserting a sheath into a cavity; and after the sheath reaches the detection position, aspirating fluid at the lesion location through the aspiration tube and aspiration port of the probe assembly of the impedance detection catheter.

[0025] Furthermore, the impedance detection catheter is the impedance detection catheter described above, and the impedance detection method further includes: placing the fitting component of the impedance detection catheter in a contracted state to insert the sheath into the cavity; after the sheath reaches the detection position, expanding the fitting component to fit against the inner wall of the cavity to position the sheath; and after positioning the sheath and aspirating the fluid from the inner wall of the cavity, using the probe of the impedance detection catheter to detect the location of the lesion.

[0026] Applying the technical solution of this invention, the present invention provides an impedance detection catheter, comprising: a sheath having a first lumen; multiple probe assemblies, each probe assembly including interconnected wires and probes, the wires being connected to the output end of a detection host, and the wires passing through the first lumen; wherein, at least some of the probe assemblies have probes having interconnected suction chambers and suction ports; the probe assembly further includes an aspiration tube communicating with the suction chambers to aspirate fluid from the lesion site through the aspiration tube and the suction chambers. With the above configuration, when performing impedance detection, the impedance detection catheter aspirates fluid from the lumen through the aspiration tube, suction chamber, and suction port, ensuring that the probes are in close contact with the tissue within the lumen, thereby making the detection data more accurate. Attached Figure Description

[0027] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings:

[0028] Figure 1 A schematic diagram of the overall structure of an embodiment of the impedance detection catheter according to the present invention is shown;

[0029] Figure 2 It shows that according to Figure 1 An enlarged schematic diagram of region A of the impedance detection catheter;

[0030] Figure 3 A schematic diagram of the aspiration tube inside the sheath of the impedance detection catheter according to the present invention is shown;

[0031] Figure 4 A schematic diagram of the buffer element within the insulating base of the impedance detection conduit according to the present invention is shown;

[0032] Figure 5 A cross-sectional view of the probe of the impedance detection catheter according to the present invention is shown;

[0033] Figure 6 A schematic diagram of the internal structure of the handle component of the impedance detection conduit according to the present invention is shown;

[0034] Figure 7 A schematic diagram of the structure of the impedance detection catheter according to the present invention, showing the fitting component disposed on the sheath;

[0035] Figure 8 It shows according to Figure 7 An enlarged schematic diagram of region B of the impedance detection catheter;

[0036] Figure 9 A schematic diagram of the structure of the impedance detection catheter according to the present invention, wherein the balloon component is disposed on the sheath, is shown.

[0037] Figure 10 It shows according to Figure 9 A magnified schematic diagram of region C of the impedance detection catheter;

[0038] Figure 11 A schematic diagram of a radiopaque ring disposed on a sheath within the fitting assembly of an impedance detection catheter according to the present invention is shown.

[0039] Figure 12 A schematic diagram of the structure of the sheath of the impedance detection catheter according to the present invention, which is provided with a balloon component, is shown.

[0040] Figure 13 A schematic diagram of the internal structure of the handle component with an air bladder part of the impedance detection catheter according to the present invention is shown.

[0041] Figure 14 A schematic diagram of the impedance detection catheter with a cell brush according to the present invention is shown;

[0042] Figure 15 A schematic diagram of the structure of the impedance detection catheter according to the present invention is shown, in which a radiopaque ring with a cell brush and a balloon component is disposed on a sheath.

[0043] Figure 16 A schematic diagram of the sheath structure of the impedance detection catheter according to the present invention, including a cell brush and a balloon component, is shown.

[0044] The above figures include the following reference numerals:

[0045] 10. Sheath; 11. First sheath segment; 12. Second sheath segment; 110. Airway cavity; 111. Connecting opening; 130. First lumen; 140. Lead wire cavity; 150. Motion cavity;

[0046] 100. Probe assembly; 101. Lead wire; 102. Probe; 1021. Suction port; 1022. Suction chamber; 1023. Stop; 1024. Probe body; 120. Bend section; 123. Bent section; 121. First straight section; 122. Second straight section; 1220. Opening; 103. Suction tube; 1031. Main suction tube; 1032. Suction branch tube; 104. Lead wire fixing tube;

[0047] 70. Insulating base; 71. First base section; 710. Limiting groove; 711. Groove opening; 7. Stop block; 8. Buffer component; 9. Developing ring;

[0048] 2. Suction connecting tube; 3. Suction connector; 20. Adhesion assembly; 21. Airbag component; 31. Adhesion component; 310. Support strip; 301. First connecting part; 302. Second connecting part; 30. Vent valve; 40. Transition tube; 50. Valve connecting tube; 60. Detection connector; 61. Connector connecting tube; 1. Handle component; 501. Lower cover; 502. Upper cover;

[0049] 80. Cell brush assembly; 81. Brush head; 82. Connecting tube. Detailed Implementation

[0050] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0051] Please refer to Figures 1 to 16 Because the area to be tested within the cavity contains a large amount of body fluid, the electrode tip does not adhere firmly to the tissue, resulting in inaccurate test data. Therefore, this invention provides an impedance detection catheter, comprising: a sheath 10 having a first lumen 130; multiple probe assemblies 100, each probe assembly 100 including interconnected wires 101 and probes 102, the wires 101 being used to connect to the output end of a detection host, and the wires 101 passing through the first lumen 130; wherein, at least some of the probe assemblies 100 have probes 102 having interconnected suction chambers 1022 and suction ports 1021; the probe assembly 100 also includes a suction tube 103 communicating with the suction chamber 1022 to aspirate fluid from the lesion site through the suction tube 103 and the suction chamber 1022. With the above settings, when performing impedance detection, the impedance detection catheter draws liquid from the cavity through the suction tube, the suction chamber 1022 and the suction port 1021, so that the probe 102 can fully adhere to the tissue in the cavity, thereby making the detection data more accurate.

[0052] Specifically, impedance technology is a non-invasive detection technique that utilizes the electrical properties (impedance, admittance, dielectric constant, etc.) of biological tissues and organs and their changes to extract biomedical information related to human physiological and pathological conditions. It typically involves using an electrode system placed on the body surface to deliver a small alternating current or voltage to the subject, detecting the corresponding impedance and its changes, and then obtaining relevant physiological and pathological information according to different application purposes.

[0053] In order to ensure that the suction port 1021 of the probe fits well with the inner wall of the cavity, the end of the probe 102 can be a straight tube section, and the suction port 1021 can be located on the end face of the straight tube section; or, the end of the probe 102 can be a bent tube section 123, and the suction port 1021 can be located on the tube wall of the bent tube section 123.

[0054] Specifically, when the suction port 1021 is located on the end face of the straight tube section, the end face of the straight tube section is inclined to the axis of the sheath tube 10, so that the suction port 1021 is inclined to the axis of the sheath tube 10 and faces the axis of the sheath tube 10; when the end of the probe 102 is a bent tube section 123, the suction port 1021 is inclined to the axis of the sheath tube 10 and faces the axis of the sheath tube 10. Through the above arrangement, the suction port 1021 fits well with the inner wall of the cavity.

[0055] like Figures 2 to 5 As shown, when the end of the probe 102 is a bent tube section 123, the probe 102 also includes a first straight tube section 121 and a second straight tube section 122. The two ends of the bent tube section 123 are connected to the first straight tube section 121 and the second straight tube section 122 respectively. The second straight tube section 122 is located outside the sheath 10. The end of the second straight tube section 122 has an opening 1220, which communicates with the outside of the sheath 10 so that some of the liquid in the inner wall of the cavity can be drawn through the opening 1220, thus improving the suction effect.

[0056] Specifically, the impedance detection conduit also includes: an insulating base 70, a portion of which is inserted into the sheath 10, and multiple probe assemblies 100 passing through the insulating base 70; wherein, multiple limiting grooves 710 are formed on the outer peripheral wall of the insulating base 70 located outside the sheath 10, and the probes 102 of each probe assembly 100 are bent after passing through the insulating base 70 to form a bent tube section 120, and a suction port 1021 is provided on the bent tube section 120. At least a portion of the tube section 120 is located within the limiting grooves 710, so as to limit the movement of the probes 102 by the limiting grooves 710, prevent the probes 102 from being over-displaced, and the limiting grooves 710 can also guide the movement of the probes 102.

[0057] like Figure 4 As shown, the bent section 120 includes a second straight section 122 and a bent section 123 connected to each other. The suction port 1021 is disposed on the bent section 123. At least a portion of the second straight section 122 is located within the limiting groove 710. Along the extension direction of the sheath 10, the length of the limiting groove 710 is greater than the length of the second straight section 122, so that the probe 102 can move a predetermined distance within the limiting groove 710. And / or, the insulating base 70 has a first base section 71 located outside the sheath 10. The limiting groove 710 is located on the outer peripheral wall of the first base section 71. The outer diameter of the first base section 71 is equal to the outer diameter of the sheath 10, so that the first base section 71 abuts against the end of the sheath 10. In this way, liquid can be prevented from entering the sheath 10 from the gap between the probe 102 and the sheath 10, which can play a sealing role to a certain extent.

[0058] Specifically, the limiting groove 710 has a groove opening 711 along the radial direction of the second straight pipe section 122, with at least a portion of the second straight pipe section 122 located outside the groove opening 711; wherein, the limiting groove 710 extends radially along the sheath tube 10 so that the groove opening 711 is located at the edge of the sheath tube 10. This arrangement facilitates suction from the opening 1220 of the second straight pipe section 122, resulting in better suction performance.

[0059] To improve the fit between the suction port and the inner wall of the cavity, the impedance detection catheter also includes: a stop 7, which is fixed inside the sheath 10, and the probe 102 is movably inserted through the stop 7; and a buffer 8, one end of which is connected to the stop 7, and the other end of which is connected to the probe 102. The buffer 8 is pressed or released during the movement of the probe 102. During the detection process, the buffer 8 can flexibly adhere to the tissue being tested based on its position, ensuring sufficient contact and improving detection accuracy. The buffer is a spring.

[0060] Specifically, there are multiple buffer elements 8, which are sleeved on the probe 102. Each buffer element 8 corresponds one-to-one with a probe 102 in the multiple probe assemblies 100, thus improving the buffering effect. And / or, the probe 102 includes a probe body 1024 and a stop portion 1023. A suction port 1021 is disposed on the probe body 1024. The stop portion 1023 protrudes from the outer peripheral surface of the probe body 1024 and is fixedly disposed relative to the probe body 1024 to support the buffer elements. 8 is used for limiting the position. The buffer 8 is located between the stop 1023 and the stop 7. Both ends of the buffer 8 are connected to the stop 1023 and the stop 7 respectively, so that the connection between the buffer 8 and the probe 102 is stable; and / or, the impedance detection conduit also includes an insulating base 70. The insulating base 70 is sleeved on the outside of the buffer 8 and the multiple probe assemblies 100. The insulating base 70 abuts against the end face of the stop 7 on the side away from the suction tube 103, so that the seal between the stop 7 and the sheath 10 can be achieved.

[0061] like Figure 3 As shown, each probe 102 of the multiple probe assemblies 100 has a suction chamber 1022 and a suction port 1021; the suction tube 103 includes a main suction tube 1031 and multiple suction branch tubes 1032, which are connected one-to-one with the probes 102 of the multiple probe assemblies 100, and the multiple suction branch tubes 1032 are all connected to the main suction tube 1031. In this way, the suction of multiple probes 102 is combined into one main suction tube 1031, so as to realize the suction of multiple probes 102 at the same time, making the structural arrangement inside the impedance detection catheter reasonable.

[0062] In this application, the probe assembly 100 further includes multiple wire fixing tubes 104, each wire fixing tube 104 being sleeved on the corresponding probe 102 and wire 101 through its lumen. The conductive parts of the probe 102 and the wire 101 are in contact, and the probe 102 is press-fitted with the inner wall of the wire fixing tube 104, and the conductive part of the wire 101 is press-fitted with the inner wall of the wire fixing tube 104; and / or the suction tube 103 is inserted into the probe 102 to communicate with the suction chamber 1022, and the suction tube 103 is press-fitted with the probe 102. With the above arrangement, impedance detection can be performed while the probe is performing suction, and the wire fixing tube 104 makes the wire less susceptible to liquid interference.

[0063] In this application, the impedance detection conduit further includes: a suction connection tube 2 and a suction connector 3, wherein the suction tube 103 is connected to the suction connector 3 through the suction connection tube 2; a connector connection tube 61 and a detection connector 60, wherein one end of the wire 101 passes through the sheath tube 10 and then through the connector connection tube 61 and is connected to the detection connector 60; and a handle component 1, wherein the end of the sheath tube 10 away from the probe 102 is mounted on the handle component 1, and both the suction connection tube 2 and the connector connection tube 61 are mounted on the handle component 1.

[0064] The main suction tube 1031 is connected to the suction connector 3 via the suction connecting tube 2. The impedance detection catheter also includes a negative pressure suction device. The suction connector 3 is connected to the negative pressure suction device so that the suction tube 103 and the suction connecting tube 2 are connected to the negative pressure suction device. The negative pressure suction device generates negative pressure in the suction tube 103, thereby suctioning the body fluid at the location to be tested in the cavity.

[0065] like Figures 7 to 14 As shown, the impedance detection catheter further includes a fitting component 20, which is disposed on the sheath 10. At least a portion of the fitting component 20 is telescopically disposed in a direction away from the outer peripheral surface of the sheath 10, so that the fitting component 20 has an expanded state for fitting against the inner wall of the cavity and a contracted state for avoiding the inner wall of the cavity. In this application, when the fitting component 20 is in the contracted state, the sheath 10 is inserted into the cavity to reach the detection position. After reaching the detection position, the fitting component 20 begins to expand, so that the fitting component fits against the inner wall of the cavity and is in the expanded state. In this way, the sheath 10 can be positioned to prevent the sheath 10 from shifting, so that the detection is not interrupted, thereby improving the accuracy of the detection results of the impedance detection catheter. Thus, through the combination of the fitting component 20 and the suction structure such as the suction tube 103, the impedance detection catheter is further positioned accurately and will not shift during impedance detection.

[0066] Optionally, such as Figures 9 to 12As shown, the sheath 10 has an airway cavity 110, and the fitting assembly 20 includes an airbag component 21, which communicates with the airway cavity 110 to allow air to be supplied to the airbag component 21 through the airway cavity 110; wherein, the airway cavity 110 and the first lumen are spaced apart; or, as shown Figure 7 and Figure 8 As shown, the fitting assembly 20 includes a fitting component 31, and the sheath 10 includes a first sheath segment 11 and a second sheath segment 12 spaced apart. The fitting component 31 includes a first connecting part 301, a plurality of support bars 310 and a second connecting part 302 connected in sequence. At least a portion of each support bar 310 is located between the first sheath segment 11 and the second sheath segment 12. The plurality of support bars 310 are spaced apart around the sheath 10. The second connecting part 302 is fixedly connected to the second sheath segment 12, and the first connecting part 301 is fixedly connected to the first sheath segment 11. The first sheath segment 11 or the second sheath segment 12 is movably arranged to drive the first connecting part 301 or the second connecting part 302 to move, so that the plurality of support bars 310 are telescopically arranged in a direction close to or away from the axis of the sheath 10.

[0067] Optionally, each support bar 310 is a strip-shaped plate structure; or, each support bar 310 is a tubular structure.

[0068] like Figures 14 to 16 As shown, the impedance detection catheter also includes a cell brush assembly 80, which is inserted through the sheath 10, and multiple probe assemblies 100 are spaced apart around the cell brush assembly 80. The cell brush assembly 80 is retractably arranged along the extension direction of the sheath 10 to have a sampling state where at least a portion protrudes beyond the probe 102, allowing for the collection of tissue samples by brushing. This arrangement enables simultaneous collection of tissue samples by the cell brush and impedance detection by the probes, enhancing the functional versatility of the impedance detection catheter. This saves surgical time, solves the problem of limited functionality and accuracy in existing catheter technologies, and further improves the accuracy of the impedance detection catheter.

[0069] like Figure 11 and Figure 15 As shown, the impedance detection catheter also includes a radiopaque ring 9, which is disposed on the sheath 10 and located outside the probe 102. By placing the radiopaque ring 9 inside the fitting assembly 20 or on the side of the radiopaque ring 9 near the probe 102, this application makes it easier to position the end of the sheath 10 containing the probe assembly 100 under the imaging system.

[0070] Preferably, there are multiple developing rings 9, which are spaced apart along the extension direction of the sheath 10, so as to make it easier to position the end of the sheath 10 where the probe assembly 100 is located in the imaging system.

[0071] Specifically, the probe 102 can be made of stainless steel. The probe 102 is sealed to the suction tube 103 to prevent leakage of body fluid. The probe 102 is connected to the wire 101 through the wire fixing tube 104. The wire 101 is an insulated enameled wire. After the insulation layer of the end of the wire 101 near the probe assembly 100 is stripped to expose the inner copper core, the outer peripheral surface of the copper core is interference-fitted with the outer peripheral surface of the probe 102. Furthermore, the outer peripheral surface of the copper core of the wire 101 and the outer peripheral surface of the probe 102 are both interference-fitted with the inner wall surface of the cavity of the wire fixing tube 104. The other end of the wire 101 passes through the sheath tube 10 and the connector connecting tube 61 and is connected to the output end of the detection host through the Remo connector to achieve conductivity.

[0072] The wire fixing tube 104 can be made of polymer material.

[0073] Specifically, the insulating base can be made of a biocompatible polymer material. The buffer element 8 can be made of spring steel or other materials.

[0074] Among them, the sheath 10 can be made of medical catheter material with good biocompatibility, non-toxicity, corrosion resistance, bending resistance, and a certain degree of supporting strength; such as Figure 6 The handle component 1 shown is a lower cover 501, and the rear end of the sheath 10 is fixed to the lower cover. The suction tube 103 can be made of polymer material.

[0075] The handle component 1 includes an upper cover 502 and a lower cover 501. The handle component 1 can be made of polymer material. A first mounting hole, a second mounting hole and a third mounting hole are provided between the upper cover and the lower cover. The first mounting hole is for the sheath tube 10 to extend into, and the third mounting hole is for the connector tube 61 to extend out. At this time, the second mounting hole is for the suction connector tube 2 to extend out. After the upper cover and the lower cover are fastened together, the sheath tube, the suction connector tube and the connector tube are fixed between the upper cover and the lower cover.

[0076] The suction connecting tube can be made of polymer material. The suction connector 3 can be a standard part, connected to the suction connecting tube, and connected to the negative pressure suction device. The connector connecting tube 61 can be made of polymer material, through which the wire 101 passes and is soldered to the corresponding pin of the Remo connector (detection connector 60). The connector connecting tube 61 is fixed to the lower cover, and the connector connecting tube 61 is fixedly connected to the Remo connector. The Remo connector can be a standard part, with its front end connected and fixed to the connector connecting tube 61. After the wire 101 passes through the connector connecting tube 61, the wire 101 is soldered to the corresponding pin of the Remo connector, and the Remo connector is connected to the detection host.

[0077] In the specific implementation process of the embodiments of this application: 1. Insertion: The sheath 10 is inserted into the cavity with the endoscope or under the guidance of the imaging system and reaches the detection position; 2. Aspiration: The aspiration connector 3 is connected to the negative pressure suction device, the pressure is adjusted and excess fluid at the detection position is aspirated; 3. Detection: The detection data detected by the probe assembly 100 is read / recorded on the detection host; 4. Removal or repositioning detection: After the above detection is completed, the negative pressure suction device is turned off, and the catheter is withdrawn from the body through the guidance system. If repositioning detection is required, the sheath 10 is replaced, and steps 1-4 above are repeated.

[0078] The present invention also provides an impedance detection system, comprising: the impedance detection conduit described above; a detection host, wherein the probe assembly 100 of the impedance detection conduit is connected to the detection host; and a negative pressure suction device, wherein the suction connector 3 of the impedance detection conduit is connected to the negative pressure suction device.

[0079] The present invention also provides an impedance detection method applicable to the above-mentioned impedance detection catheter. The impedance detection method includes: placing the fitting component 20 in a contracted state to insert the sheath 10 into the cavity; after the sheath 10 reaches the detection position, aspirating the fluid at the lesion position through the aspiration tube 103 and the aspiration port 1021 of the probe component 100 of the impedance detection catheter.

[0080] Specifically, the impedance detection catheter is the impedance detection catheter described above. The impedance detection method further includes: expanding the fitting component 20 so that the fitting component 20 fits against the inner wall of the cavity to position the sheath 10, and after positioning the sheath 10 and aspirating the fluid from the inner wall of the cavity, using the probe 102 of the impedance detection catheter to detect the location of the lesion.

[0081] Among them, the sheath 10 is the guide tube of the balloon component 21, which is used to establish vascular access during the operation, deliver interventional equipment, and can also temporarily block blood vessels at the same time.

[0082] Specifically, the sheath tube 10 is provided with a connecting opening 111, and the airway cavity 110 is connected to the cavity of the airbag component 21 through the connecting opening 111 to inflate or deflate the airbag component 21; wherein, the connecting opening 111 is located inside the airbag component 21; and / or the airbag component 21 is sleeved on the sheath tube 10, and both ends of the airbag component 21 are sealed to the sheath tube 10 to prevent the airbag component 21 from leaking air.

[0083] Specifically, the airway cavity 110 is disposed on the wall of the sheath 10 and extends along the extension direction of the sheath 10; and / or the guide cavity 140 is the cavity of the sheath 10; and / or the impedance detection conduit includes a vent valve 30 and a valve connecting pipe 50, one end of the valve connecting pipe 50 is connected to the airway cavity 110, and the other end of the valve connecting pipe 50 is connected to the vent valve 30. The vent valve 30 is used to connect to a gas supply device to regulate the amount of gas entering the airbag component 21.

[0084] Specifically, the impedance detection conduit includes a transition tube 40, one end of the valve connection tube 50 is connected to the airway cavity 110 through the transition tube 40, and the other end of the valve connection tube 50 is connected to the ventilation valve 30.

[0085] The impedance detection conduit also includes a detection host, and the detection connector 60 is a Remo connector. The Remo connector is connected to the output end of the detection host so that the probe 102 is connected to the output end of the device through the wire 101 and the detection connector 60 to achieve conduction.

[0086] Multiple suction pipes 1032 are evenly distributed on the cross-section of the main suction pipe 1031.

[0087] In this application, the sheath 10 has a motion chamber 150, and the cell brush assembly 80 is movably disposed within the motion chamber 150; the sheath 10 also includes an airway chamber 110 and a guide chamber 140, with the guide 101 disposed within the guide chamber 140.

[0088] Specifically, the sheath 10 is a tube with multiple cavities, and there are multiple guide tube cavities 140. The airway cavity 110 and the multiple guide tube cavities 140 are arranged at intervals around the motion cavity 150.

[0089] Optionally, the airbag component 21 is a spherical structure; or, the airbag component 21 is an ellipsoidal spherical structure.

[0090] In this application, the sheath 10 may be made of a medical catheter material that is biocompatible, non-toxic and harmless, corrosion-resistant, bend-resistant, and has a certain supporting strength.

[0091] The first embodiment, as Figure 10 and Figure 12 As shown:

[0092] The sheath 10 is divided into two independent chambers: an airway chamber 110 and a lead wire chamber 140. The airway chamber 110 is a sealed chamber through which gas reaches the airbag component 21, while the lead wire chamber 140 allows the lead wire 101 to pass through. Two independent tubing lines are provided at the end of the sheath 10 furthest from the probe assembly 100. The airway chamber 110 is sealed to the ventilation valve 30 via a valve connecting pipe 50, and the lead wire 101 is connected to the Remo connector (detection connector 60) via a connector connecting pipe 61. The handle component 1 includes an upper cover and a lower cover connected to each other, with at least a portion of the valve connecting pipe 50 and the connector connecting pipe 61 located between the upper and lower covers. The upper and lower covers are distributed along the thickness direction of the handle component 1.

[0093] Among them, the vent valve 30 is used to connect to the gas supply equipment, and the Remo connector is connected to the output end of the detection host of the impedance detection conduit.

[0094] Specifically, the probe 102 is made of 304 stainless steel and is welded to the wire 101. The end of the probe 102 away from the wire 101 is fixed in the probe hole on the insulating base 70.

[0095] Specifically, the conductor 101 is an insulated enameled wire. After the insulation layer is stripped off at one end of the conductor 101 to expose the inner copper core, the copper core is fixed to the probe 102 by welding. The other end of the conductor 101 passes through the inside of the sheath tube so that the conductor 101 is connected to the output end of the detection host of the impedance detection conduit through the connector connecting tube 61 and the Remo connector to achieve conduction.

[0096] Specifically, the insulating base 70 is made of a biocompatible polymer material, the probe 102 penetrates through the pre-set cavity, and the insulating base 70 is bonded to the sheath 10.

[0097] The insulating base 70 includes a first insulating section and a second insulating section. The cross-sectional area of ​​the first insulating section is smaller than that of the second insulating section, so that an installation step is formed between the first insulating section and the second insulating section. The installation step is matched with the end of the sheath tube 10 to limit the fit, so that the insulating base 70 is bonded to the sheath tube 10 through the installation step.

[0098] Specifically, the airbag component 21 is made of a high-pressure resistant polymer material, and the airbag component 21 is sealed to the sheath tube 10; along the extension direction of the sheath tube 10, the connecting opening 111 on the sheath tube 10 is located at the center of the balloon.

[0099] In the specific implementation of the first embodiment, the airbag component 21 is initially in a contracted state. After the sheath 10 and probe assembly 100 reach the detection position guided by an endoscope or guidance system, the ventilation valve 30 is opened, and a certain volume of gas is introduced into the airway cavity 110 through the air supply device, causing the airbag component 21 to inflate. The airbag component 21 is tightly attached to the inner wall of the cavity, at which point the entire structure presents... Figure 1 The shape shown is used to limit the position of the sheath 10. During impedance testing, the probe 102 contacts the tissue to be tested to detect the voltage across the tissue and the current flowing through it. The test results are fed back to the main unit, which calculates the resistivity and records the data. After the above tests are completed, the ventilation valve 30 is turned to release the gas from the airbag component 21. Guided by the guidance system, the sheath 10 is withdrawn from the body. If a different position is required for testing, the catheter is replaced, and the above steps are repeated.

[0100] The second embodiment, as follows Figures 14 to 16 As shown:

[0101] A cell brush assembly 80 is provided on the sheath 10 to obtain tissue samples for biopsy during or after impedance detection, saving surgical time. The cell brush assembly 80 includes a connecting tube 82 and a brush head 81.

[0102] Specifically, the brush head can be made of polymer or natural materials; the connecting tube can be made of stainless steel; the cable can be made of stainless steel or nickel-titanium; the electrode (probe 102) can be made of stainless steel; and the sheath 10 can be made of medical catheter material that is biocompatible, non-toxic, harmless, corrosion-resistant, bend-resistant, and has a certain supporting strength.

[0103] In this embodiment, the sheath 10 is provided with two cavities: a lead wire cavity 140 and a movement cavity 150; after the lead wire 101 passes through the lead wire cavity 140, the end of the lead wire away from the probe assembly 100 extends out and connects to the detection connector 60, and the brush head 81 of the cell brush assembly 80 moves in the movement cavity 150.

[0104] Specifically, the wire 101 is an insulated enameled wire. The insulation layer of the end of the wire near the probe assembly 100 is stripped to expose the inner copper core. The inner copper core is soldered to the probe 102. The end of the wire 101 away from the probe assembly 100 passes through the sheath tube 10 and the connector connecting tube 61 and then passes through to connect the wire to the detection connector 60. The detection connector 60 is connected to the output end of the detection host to achieve conductivity.

[0105] Specifically, the handle component 1 may be made of polymer material.

[0106] Among them, the test connector 60 can be a standard part. One end of the test connector 60 is connected and fixed to the connector connecting tube 61. After the wire 101 extends through the connector connecting tube 61, the wire 101 is soldered to the corresponding pin of the Remo connector (test connector 60). The Remo connector is connected to the test host.

[0107] In the specific implementation of the second embodiment, 1. Tube delivery: the sheath 10 is as follows Figure 16 In the initial state shown, the endoscope or other guiding device enters the cavity and reaches the detection position under the guidance of the imaging system. At this time, the brush head 81 of the cell brush assembly 80 is not extended. 2. Detection: Detection data is read / recorded on the detection host. 3. Tissue collection: The brush head 81 is extended to collect tissue samples. 4. Tube removal or repositioning detection: After the above detection is completed, the brush head 81 is retracted into the sheath 10, and then the sheath 10 is withdrawn from the body through the guidance system. If repositioning detection is required, the sheath 10 is replaced, and steps 1-4 above are repeated. In summary, this application can solve the problem that impedance detection and biopsy cannot be performed simultaneously, adds biopsy function, and improves the accuracy of diagnosis.

[0108] As can be seen from the above description, the embodiments of the present invention achieve the following technical effects:

[0109] This invention provides an impedance detection catheter, comprising: a sheath 10 having a first lumen 130; a plurality of probe assemblies 100, each probe assembly 100 including an interconnected wire 101 and a probe 102, the wire 101 being connected to the output end of a detection host, and the wire 101 passing through the first lumen 130; wherein, at least some of the probe assemblies 100 have probes 102 having interconnected suction chambers 1022 and suction ports 1021; the probe assembly 100 further includes a suction tube 103 communicating with the suction chamber 1022 to aspirate fluid from the lesion site through the suction tube 103 and the suction chamber 1022. With the above configuration, when performing impedance detection, the impedance detection catheter aspirates fluid from the lumen through the suction tube, suction chamber 1022, and suction port 1021, ensuring that the probe 102 is in close contact with the tissue within the lumen, thereby making the detection data more accurate.

[0110] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An impedance detection catheter, characterized in that, include: Sheath (10), the sheath (10) having a first lumen (130); Multiple probe assemblies (100), each of the probe assemblies (100) includes interconnected wires (101) and probes (102), the wires (101) are used to connect to the output end of the detection host, and the wires (101) pass through the first lumen (130); Among them, at least a portion of the probe assemblies (100) have probes (102) having interconnected suction chambers (1022) and suction ports (1021); the probe assembly (100) also includes a suction tube (103) communicating with the suction chamber (1022) to aspirate fluid from the lesion site through the suction tube (103) and the suction chamber (1022); The impedance detection conduit also includes: An insulating base (70) is partially inserted into the sheath (10), and multiple probe assemblies (100) are inserted through the insulating base (70). Multiple limiting grooves (710) are provided on the outer peripheral wall of the insulating base (70) located outside the sheath (10). The probes (102) of each probe assembly (100) are bent after passing through the insulating base (70) to form a bent tube section (120). A suction port (1021) is located on the bent tube section (120), and at least a portion of the bent tube section (120) is located within the limiting grooves (710). The bent section (120) includes a second straight section (122) and a bent section (123) connected to each other. The suction port (1021) is disposed on the bent section (123). At least a portion of the second straight section (122) is located within the limiting groove (710). Along the extension direction of the sheath (10), the length of the limiting groove (710) is greater than the length of the second straight section (122). The insulating base (70) has a first base section (71) located outside the sheath (10). The limiting groove (710) is located on the outer peripheral wall of the first base section (71). The outer diameter of the first base section (71) is equal to the outer diameter of the sheath (10) so that the first base section (71) abuts against the end of the sheath (10). The limiting groove (710) has a groove opening (711) along the radial direction of the second straight pipe section (122), at least a portion of the second straight pipe section (122) being located outside the groove opening (711); wherein the limiting groove (710) extends radially along the sheath (10) such that the groove opening (711) is located at the edge of the sheath (10).

2. The impedance detection conduit according to claim 1, characterized in that, The end of the probe (102) is a bent tube section (123), and the suction port (1021) is located on the tube wall of the bent tube section (123).

3. The impedance detection conduit according to claim 2, characterized in that, When the end of the probe (102) is a bent tube section (123), the suction port (1021) is inclined to the axis of the sheath (10) and is set toward the axis of the sheath (10).

4. The impedance detection conduit according to claim 2, characterized in that, When the end of the probe (102) is a bent tube section (123), the probe (102) also includes a first straight tube section (121) and a second straight tube section (122). The two ends of the bent tube section (123) are respectively connected to the first straight tube section (121) and the second straight tube section (122). The second straight tube section (122) is located outside the sheath (10). The end of the second straight tube section (122) has an opening (1220). The opening (1220) communicates with the outside of the sheath (10) so that part of the liquid in the inner wall of the cavity is drawn through the opening (1220).

5. The impedance detection conduit according to claim 1, characterized in that, The impedance detection conduit also includes: A stop (7) is fixed inside the sheath (10), and the probe (102) is movably inserted through the stop (7); A buffer (8) is provided, one end of which is connected to the stop (7) and the other end of which is connected to the probe (102) to press or release the buffer (8) during the movement of the probe (102).

6. The impedance detection conduit according to claim 5, characterized in that, There are multiple buffer elements (8), each buffer element (8) is sleeved on the probe (102), and the multiple buffer elements (8) are arranged one-to-one with the probes (102) of the multiple probe assemblies (100); and / or, The probe (102) includes a probe body (1024) and a stop (1023), and the suction port (1021) is disposed on the probe body (1024); the stop (1023) protrudes from the outer peripheral surface of the probe body (1024) and is fixedly disposed relative to the probe body (1024) to limit the buffer (8), the buffer (8) is located between the stop (1023) and the stop (7), and both ends of the buffer (8) are respectively connected to the stop (1023) and the stop (7); and / or, The impedance detection conduit also includes an insulating base (70), which is sleeved on the outside of the buffer (8) and the plurality of probe assemblies (100), and the insulating base (70) abuts against the end face of the stop (7) on the side away from the suction tube (103).

7. The impedance detection conduit according to any one of claims 1 to 6, characterized in that, The probes (102) of the plurality of probe assemblies (100) each have the suction chamber (1022) and the suction port (1021). The suction tube (103) includes a main suction tube (1031) and multiple suction branch tubes (1032). The multiple suction branch tubes (1032) are connected to the probes (102) of the multiple probe assemblies (100) in a one-to-one correspondence. The multiple suction branch tubes (1032) are all connected to the main suction tube (1031).

8. The impedance detection conduit according to any one of claims 1 to 6, characterized in that, The probe assembly (100) further includes a plurality of wire fixing tubes (104), each of which is sleeved on the corresponding probe (102) and the wire (101) through its lumen. The conductive parts of the probe (102) and the wire (101) are in contact. The probe (102) is press-fitted with the inner wall of the wire fixing tube (104), and the conductive part of the wire (101) is press-fitted with the inner wall of the wire fixing tube (104); and / or The suction tube (103) is inserted into the probe (102) to communicate with the suction chamber (1022), and the suction tube (103) and the probe (102) are interference-fitted.

9. The impedance detection catheter according to any one of claims 1 to 6, characterized in that, The impedance detection conduit also includes: A suction connecting tube (2) and a suction connector (3), wherein the suction tube (103) is connected to the suction connector (3) through the suction connecting tube (2); The connector connecting tube (61) and the detection connector (60) are connected together. One end of the wire (101) passes through the sheath tube (10) and then through the connector connecting tube (61) and is connected to the detection connector (60). Handle component (1), the end of the sheath (10) away from the probe (102) is mounted on the handle component (1), the suction connecting tube (2) and the connector connecting tube (61) are both mounted on the handle component (1).

10. The impedance detection catheter according to any one of claims 1 to 6, characterized in that, The impedance detection conduit also includes: Adhesion assembly (20) is disposed on the sheath (10), at least a portion of the adhesion assembly (20) is extensibly disposed in a direction away from the outer peripheral surface of the sheath (10) so that the adhesion assembly (20) has an expanded state for adhering to the inner wall of the cavity and a contracted state for avoiding the inner wall of the cavity.

11. The impedance detection conduit according to claim 10, characterized in that, The sheath (10) has an airway cavity (110), and the fitting assembly (20) includes an airbag component (21) communicating with the airway cavity (110) to ventilate the airbag component (21) through the airway cavity (110); wherein the airway cavity (110) and the first lumen are spaced apart; or, The fitting assembly (20) includes a fitting component (31). The sheath (10) includes a first sheath segment (11) and a second sheath segment (12) spaced apart. The fitting component (31) includes a first connecting part (301), a plurality of support bars (310), and a second connecting part (302) connected in sequence. At least a portion of each support bar (310) is located between the first sheath segment (11) and the second sheath segment (12). The plurality of support bars (310) are spaced apart around the sheath (10). The second connecting part (302) is fixedly connected to the second sheath segment (12). The first connecting part (301) is fixedly connected to the first sheath segment (11). The first sheath segment (11) or the second sheath segment (12) is movably arranged to drive the first connecting part (301) or the second connecting part (302) to move, so that the plurality of support bars (310) are telescopically arranged in a direction close to or away from the axis of the sheath (10).

12. The impedance detection catheter according to any one of claims 1 to 6, characterized in that, The impedance detection conduit also includes: A cell brush assembly (80) is inserted through the sheath (10), and a plurality of probe assemblies (100) are arranged at intervals around the cell brush assembly (80); The cell brush assembly (80) is telescopically disposed along the extension direction of the sheath (10) to have a sampling state that at least partially protrudes from the probe (102) so as to brush tissue samples through the cell brush assembly (80).

13. The impedance detection catheter according to any one of claims 1 to 6, characterized in that, The impedance detection conduit also includes: A developing ring (9) is disposed on the sheath (10) and located outside the probe (102).

14. An impedance detection system, characterized in that, include: Impedance detection catheter as described in any one of claims 1 to 13; The detection host is connected to the probe assembly (100) of the impedance detection conduit. The negative pressure suction device is connected to the suction connector (3) of the impedance detection catheter.

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