Steam ablation needle integrating pressure-temperature non-invasive monitoring function

Abstract

The invention discloses a steam ablation needle integrating a pressure-temperature non-invasive monitoring function, and belongs to the field of steam thermal ablation. One end of the ablation needle is fixedly connected to the double-layer stainless steel vacuum tube, the other end of the double-layer stainless steel vacuum tube is fixed to the head of the reducer union, tail end threads of the reducer union are fixed to front end threads of the PEEK tube connector, the PEEK tube connector is provided with a pressure-temperature monitoring probe inlet, and the head of the pressure-temperature monitoring probe extends to the head of the ablation needle. A steam transmission stainless steel pipe is connected into the PEEK pipe connector, one end of the steam transmission stainless steel pipe is connected into the PEEK pipe connector, and the other end of the steam transmission stainless steel pipe is connected to a steam generator. According to the invention, the steam pressure and temperature of the ablation center can be measured while continuous and stable steam ablation is realized, and accurate evaluation of steam thermal ablation is realized.

Description

Technical Field

[0001] This application relates to the technical field of steam thermal ablation, and particularly relates to a steam ablation needle integrating non-invasive pressure-temperature monitoring functions. Background Art

[0002] During the steam ablation process of the steam ablation needle, the gas pressure at the steam outlet directly affects tissue deformation. Excessive pressure is likely to cause tissue tearing and affect the shape of the ablation area. Therefore, using a pressure sensor to monitor and control the steam pressure in real time is a key measure to evaluate the ablation effect.

[0003] Temperature determines whether the cells at the ablation site are completely inactivated. Taking liver tissue as an example, when the temperature is 60°C, the tissue cells are completely inactivated, and effective ablation can be achieved; temperatures above 130°C will cause tissue carbonization. Therefore, if the temperature at the ablation center can be non-invasively detected while performing ablation and the temperature is controlled between 60°C and 130°C, the carbonization phenomenon caused by too high temperature can be avoided.

[0004] Currently, there is a lack of a steam ablation needle integrating non-invasive pressure-temperature detection functions. Summary of the Invention

[0005] This application provides a steam ablation needle integrating non-invasive pressure-temperature monitoring functions, which can accurately monitor the pressure and temperature of the ablation center target while performing thermal ablation, and achieve precise evaluation of thermal ablation.

[0006] This application provides a steam ablation needle integrating non-invasive pressure-temperature monitoring functions, including: an ablation needle head, a double-layer stainless steel vacuum tube, a reducing joint, a pressure-temperature monitoring probe, a PEEK tube joint, a steam transmission stainless steel tube, and a rubber heat insulation tube sleeve; the materials of the ablation needle head, the double-layer stainless steel vacuum tube, the reducing joint, and the steam transmission stainless steel tube are 304 medical stainless steel;

[0007] A steam outlet is provided on the ablation needle head, and there are openings at the front end. The tail end of the ablation needle head is fixedly connected to one end of the double-layer stainless steel vacuum tube;

[0008] The other end of the double-layer stainless steel vacuum tube is fixedly connected to the head of the reducing joint, and the tail end of the reducing joint and the front end of the PEEK tube joint are fixedly connected by threads;

[0009] Two holes are opened inside the PEEK tube joint, which are respectively connected to the pressure-temperature monitoring probe and the steam transmission stainless steel tube. The head of the pressure-temperature monitoring probe passes through the double-layer stainless steel vacuum tube from the opening of the PEEK tube joint and extends out from the opening at the front end of the ablation needle head;

[0010] One end of the steam transmission stainless steel pipe is connected to the inside of the PEEK pipe joint, and the other end extends and is connected to the steam generator.

[0011] The rubber heat insulation pipe sleeve is wrapped around the outside of the steam transmission stainless steel pipe.

[0012] Optionally, in the embodiment of the present application, the ablation needle head includes a puncture tip and a puncture needle rod. The total length of the ablation needle head is 28 mm. The puncture tip is a hollow cone, and the puncture needle rod is a hollow cylinder. The inner diameters of the puncture tip and the puncture needle rod are both 1.8 mm, and the outer diameters are both 2.0 mm.

[0013] Optionally, in the embodiment of the present application, a pressure-temperature monitoring probe outlet is provided at the head of the puncture tip. The pressure-temperature monitoring probe outlet is a round hole with a diameter of 1 mm. Steam outlets are evenly distributed around the puncture needle rod. In the axial direction of the puncture needle rod, 15 steam outlets are arranged in a row, and the adjacent hole spacing is 0.2 mm. In the circumferential direction of the puncture needle rod, 8 steam outlets are arranged in a circle, and the adjacent hole interval is 45°. The diameter of each steam outlet is 0.2 mm.

[0014] Optionally, in the embodiment of the present application, the maximum diameter of the outer catheter of the pressure-temperature monitoring probe is 1.2 mm, the wire length is 200 mm, the pressure measurement range is 10 - 150 mmHg, the pressure accuracy is ±2 mmHg, the temperature measurement range is 15 - 180 °C, and the maximum accuracy is ±0.3 °C.

[0015] Optionally, in the embodiment of the present application, a piezoresistive wafer and a thermistor are placed at the head of the pressure-temperature monitoring probe. The piezoresistive wafer selects a MEMS half-bridge micro-pressure sensor based on the piezoresistive effect of silicon, and two external resistors form a Wheatstone bridge. By obtaining the electrical signal of the part to be measured, the pressure measurement is realized; the B value of the thermistor is 3950, and the resistance value is 10 KΩ to realize real-time temperature measurement; the piezoresistive wafer and the thermistor are placed in a titanium alloy probe shell with a surface window, and silicone is used for electrical isolation and protection. The interface of the sensor is connected to the pressure-temperature acquisition board.

[0016] Optionally, in an embodiment of the present application, an internal thread is provided at the tail end of the reducing joint, and an external thread is provided at the front end of the PEEK pipe joint. The tail end of the reducing joint is threadedly connected to the front end of the PEEK pipe joint; the front end outlet of the PEEK pipe joint is flexible and is screwed into the reducing joint through an external thread structure. The reducing joint has a gradually decreasing inner diameter. The tail end of the PEEK pipe joint is provided with a connection port for the PEEK pipe joint and the steam transmission stainless steel pipe and a connection port for the PEEK pipe joint and the pressure-temperature monitoring probe; the connection port for the PEEK pipe joint and the steam transmission stainless steel pipe is horizontally arranged, and the connection port for the PEEK pipe joint and the pressure-temperature monitoring probe is obliquely cut.

[0017] A steam ablation needle integrating the function of non-invasive pressure-temperature monitoring in the present application has multiple rows and columns of steam outlets designed at the needle tip, which can evenly transmit the steam, avoid excessive heat accumulation at a single point, make the heat transfer more uniform, and have a larger effective ablation range. The steam ablation needle of the present application integrates the functions of pressure-temperature monitoring, and can monitor the pressure and temperature in the ablation center area in real time to evaluate the ablation effect without inserting a pressure-temperature monitoring probe beside it. When the pressure and temperature in the central area deviate from the safe value, the output parameters of the steam can be adjusted in time to ensure the ablation effect.

[0018] Additional aspects and advantages of the present application will be given in part in the following description, become apparent in part from the following description, or be understood through the practice of the present application. Description of the Drawings

[0019] The above and / or additional aspects and advantages of the present application will become apparent and easy to understand from the following description of the embodiments in conjunction with the drawings, where:

[0020] Figure 1 is a schematic cross-sectional structure diagram of a steam ablation needle integrating the function of non-invasive pressure-temperature monitoring provided by an embodiment of the present application;

[0021] Figure 2 is a schematic three-dimensional structure diagram of a steam ablation needle integrating the function of non-invasive pressure-temperature monitoring provided by an embodiment of the present application;

[0022] Figure 3 is a schematic cross-sectional structure diagram of the ablation needle tip provided by an embodiment of the present application;

[0023] Figure 4 is a schematic cross-sectional structure diagram of the PEEK pipe joint provided by an embodiment of the present application;

[0024] Figure 5 is a schematic diagram of the pressure-temperature monitoring probe provided by an embodiment of the present application;

[0025] Figure 6 Schematic diagram of the system connection of a steam ablation needle integrating non-invasive pressure-temperature monitoring function according to an embodiment of the present application. Detailed implementation manners

[0026] The embodiments of the present application will be described in detail below. Examples of the embodiments are shown in the accompanying drawings, where the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to explain the present application, and should not be construed as a limitation of the present application.

[0027] As Figure 1 and Figure 2 shown, the steam ablation needle integrating non-invasive pressure-temperature monitoring function includes: an ablation needle head 1, a double-layer stainless steel vacuum tube 2, a reduced-diameter joint 3, a PEEK tube joint 4, a pressure-temperature monitoring probe 5, a steam transmission stainless steel tube 6, and a rubber heat insulation tube sleeve 7.

[0028] Among them, as Figure 3 shown, a steam outlet 1.2 is provided on the ablation needle head 1, and the front end is opened as the head outlet of the pressure-temperature monitoring probe. The tail end of the ablation needle head 1 is fixedly connected to one end of the double-layer stainless steel vacuum tube 2; the other end of the double-layer stainless steel vacuum tube 2 is fixedly connected to the head of the reduced-diameter joint 3, and the tail end of the reduced-diameter joint 3 and the front end of the PEEK tube joint 4 are fixedly connected by threads; two holes are opened inside the PEEK tube joint 4, which are respectively connected to the pressure-temperature monitoring probe 5 and the steam transmission stainless steel tube 6. The head of the pressure-temperature monitoring probe 5 passes through the double-layer stainless steel vacuum tube 2 from the opening of the PEEK tube joint 4 and extends out from the front-end opening of the ablation needle head 1; one end of the steam transmission stainless steel tube 6 is connected to the inside of the PEEK tube joint 4, and the other end extends and is connected to a steam generator; the rubber heat insulation tube sleeve 7 is wrapped outside the steam transmission stainless steel tube 6 to prevent the loss of steam heat.

[0029] A layer of anti-adhesive layer material is coated on the surfaces of the ablation needle head 1, the double-layer stainless steel vacuum tube 2 and the reduced-diameter joint 3. A threaded connection is adopted between the reduced-diameter joint 3 and the PEEK tube joint 4, which is convenient for postoperative inspection and disassembly and replacement of parts. The pressure-temperature monitoring probe 5 extends in from the connection port between the PEEK tube joint and the pressure-temperature monitoring probe until the head outlet of the pressure-temperature monitoring probe at the needle head. High-temperature water steam is injected into the steam transmission stainless steel tube 6, is transmitted along the double-layer stainless steel vacuum tube 2, reaches the steam outlet, and ablates the tissue.

[0030] In the embodiment of the present application, the materials of the ablation needle head, the double-layer stainless steel vacuum tube, the reduced-diameter joint and the steam transmission stainless steel tube are 304 medical stainless steel.

[0031] In an embodiment of the present application, the ablation needle 1 includes a puncture tip and a puncture needle shaft. The total length of the ablation needle is 28 mm. The puncture tip is a hollow cone, and the puncture needle shaft is a hollow cylinder. The inner diameters of both the puncture tip and the puncture needle shaft are 1.8 mm, and the outer diameters are both 2.0 mm.

[0032] In an embodiment of the present application, a pressure-temperature monitoring probe outlet 1.1 is provided at the head of the puncture tip. The pressure-temperature monitoring probe outlet is a round hole with a diameter of 1 mm. Steam outlets are evenly distributed around the puncture needle shaft, allowing steam to escape from here. Axially on the puncture needle shaft, 15 steam outlets are arranged in a row, with a hole spacing of 0.2 mm between adjacent holes. Circumferentially on the puncture needle shaft, 8 steam outlets are arranged in a circle, with an adjacent hole interval of 45°. The diameter of each steam outlet is 0.2 mm. In the present application, different-sized ablation regions can be formed by modifying the opening size and hole spacing of the puncture needle shaft.

[0033] In an embodiment of the present application, the outer diameter of the outer layer tube of the double-layer stainless steel vacuum tube is 2.4 mm, the inner diameter is 1.8 mm, the interlayer is vacuum, and both ends are sealed for heat insulation; 1 mm of the inner layer tube protrudes outward to facilitate assembly and welding with the needle. The double-layer stainless steel vacuum tube, the ablation needle, and the reducer joint are fixed by welding. The reducer joint and the PEEK tube joint are fixed by threading, and raw tape is inserted between the threads as a water leakage prevention measure. The PEEK tube joint and the steam transmission stainless steel tube are fixed by a combination of silicone gel and raw tape. The PEEK tube joint and the pressure-temperature monitoring probe are fixed by a combination of silicone gel and raw tape. When bonding, a high-temperature-resistant silicone sealant is used as the adhesive.

[0034] In an embodiment of the present application, the maximum diameter of the outer catheter of the pressure-temperature monitoring probe is 1.2 mm, the wire length is 200 mm, the pressure measurement range is 10 - 150 mmHg, the pressure accuracy is ±2 mmHg, the temperature measurement range is 15 - 180 °C, and the maximum accuracy is ±0.3 °C.

[0035] In an embodiment of the present application, as Figure 4 shown, the tail end of the PEEK tube joint 4 is provided with a PEEK tube joint and steam transmission stainless steel tube connection port 4.1 and a PEEK tube joint and pressure-temperature monitoring probe connection port 4.2; the PEEK tube joint and steam transmission stainless steel tube connection port is horizontally arranged, and the PEEK tube joint and pressure-temperature monitoring probe connection port is obliquely cut.

[0036] In an embodiment of the present application, as Figure 5As shown in the figure, a pressure-measuring wafer and a thermistor are placed at the head of the pressure-temperature monitoring probe. The pressure-measuring wafer selects a MEMS half-bridge micro-pressure sensor based on the piezoresistive effect of silicon, and is externally equipped with two ordinary resistors to form a Wheatstone bridge. By acquiring the electrical signal of the part to be measured, the measurement of pressure is realized; the B value of the thermistor is 3950 and the resistance value is 10K, so as to realize real-time temperature measurement; the pressure-measuring wafer and the thermistor are placed in a titanium alloy probe housing with a surface opening, and are electrically isolated and protected with silicone. The interface of the sensor is connected to the pressure-temperature acquisition board.

[0037] In the embodiment of the present application, an internal thread is provided at the tail end of the reducing joint, and an external thread is provided at the front end of the PEEK pipe joint. The tail end of the reducing joint is threadedly connected to the front end of the PEEK pipe joint; the front end outlet of the PEEK pipe joint is made of a flexible material and is screwed into the reducing joint through an external thread structure. The reducing joint has a gradually shrinking inner diameter to match and guide the flexible front end outlet of the PEEK pipe joint. As the thread is gradually tightened, the flexible front end of the PEEK pipe joint is compressed and pushed deeper into the reducing joint, and at the same time its outlet diameter gradually shrinks accordingly. This design realizes an efficient, reliable and airtight fit between the PEEK pipe joint and the steam transmission stainless steel pipe, improves the overall sealing performance of the system, simplifies the installation process and reduces the maintenance cost.

[0038] In the embodiment of the present application, the heat-insulating pipe sleeve is made of rubber material, has high temperature resistance, flexibility and aging resistance, can protect the inner steam transmission stainless steel pipe from loss, and at the same time ensures that the heat is not lost as much as possible during the steam transmission process, and at the same time enables the pipe sleeve to maintain stable performance in a high temperature environment, greatly extending the service life.

[0039] As Figure 6 shown, it shows the connection of a steam ablation needle integrating non-invasive pressure-temperature monitoring function during application, including: a - pig liver; b - MCU; c - steam generator; d - host computer. Before ablation starts, first puncture the steam ablation needle with pressure-temperature monitoring function into the tissue of the pig liver a and wait for ablation. The host computer d can control the steam generator c to generate high-temperature water vapor and transmit it to the ablation needle. The pressure-temperature monitoring probe monitors the pressure and temperature signals at the ablation center respectively, transmits them to the MCU b, and the obtained information is transmitted to the host computer d for experimental personnel to analyze and record.

[0040] A steam ablation needle integrating non-invasive pressure-temperature monitoring function proposed according to the embodiment of the present application can measure the steam pressure and temperature at the ablation center while realizing continuous and stable steam ablation, and realize the accurate evaluation of steam thermal ablation.

[0041] In the description of this specification, the descriptions referring to terms such as "one embodiment", "some embodiments", "some examples", "specific examples", or "some examples" mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of this application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in any one or N embodiments or examples in a suitable manner. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0042] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of the features. In the description of this application, "a plurality" means at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

Claims

1. A steam ablation needle integrating pressure-temperature non-invasive monitoring function, characterized in that: include: Ablation needle, double-layer stainless steel vacuum tube, reducer, pressure-temperature monitoring probe, PEEK pipe joint, steam transmission stainless steel tube, rubber insulation tube sleeve; the ablation needle, the double-layer stainless steel vacuum tube, the reducer and the steam transmission stainless steel tube are made of 304 medical stainless steel; The ablation needle is provided with a steam outlet, a hole is opened at the front end, and the tail end of the ablation needle is fixedly connected to one end of the double-layer stainless steel vacuum tube; The other end of the double-layer stainless steel vacuum tube is fixed to the head of the reducer, and the tail end of the reducer and the front end of the PEEK pipe joint are fixedly connected by threads; Two holes are opened inside the PEEK pipe joint, respectively connecting the pressure-temperature monitoring probe and the steam transmission stainless steel pipe, and the head of the pressure-temperature monitoring probe passes through the double-layer stainless steel vacuum tube from the opening of the PEEK pipe joint and then extends out from the front end opening of the ablation needle; One end of the steam transmission stainless steel pipe is connected to the inside of the PEEK pipe joint, and the other end is extended and connected to the steam generator; The rubber heat-insulating pipe sleeve is wrapped around the outside of the steam transmission stainless steel pipe.

2. The steam ablation needle integrating pressure-temperature non-invasive monitoring function according to claim 1, characterized in that: The ablation needle includes a puncture needle tip and a puncture needle rod. The total length of the ablation needle is 28 mm. The puncture needle tip is a hollow cone, and the puncture needle rod is a hollow cylinder. The inner diameter of the puncture needle tip and the puncture needle rod are both 1.8 mm, and the outer diameter is both 2.0 mm.

3. The steam ablation needle integrating pressure-temperature non-invasive monitoring function according to claim 2, characterized in that: The head of the puncture needle tip is provided with a pressure-temperature monitoring probe outlet, which is a circular hole with a diameter of 1 mm. Evenly distributed steam outlets are provided around the puncture needle rod. In the axial direction of the puncture needle rod, 15 steam outlets are provided in a row, and the spacing between adjacent holes is 0.2 mm. In the circumferential direction of the puncture needle rod, 8 steam outlets are provided in a circle, and the adjacent holes are spaced 45° apart. The diameter of each steam outlet is 0.2 mm.

4. The steam ablation needle integrating pressure-temperature non-invasive monitoring function according to claim 1, characterized in that: The outer catheter of the pressure-temperature monitoring probe has a maximum diameter of 1.2 mm, a wire length of 200 mm, a pressure measurement range of 10 to 150 mmHg, a pressure accuracy of ±2 mmHg, a temperature measurement range of 15 to 180°C, and a maximum accuracy of ±0.3°C.

5. The steam ablation needle integrating pressure-temperature non-invasive monitoring function according to claim 1, characterized in that: A pressure measuring wafer and a thermistor are placed at the head of the pressure-temperature monitoring probe. The pressure measuring wafer uses a MEMS half-bridge micro-pressure sensor based on the silicon piezoresistive effect, and two external resistors form a Wheatstone bridge. The pressure measurement is achieved by acquiring the electrical signal of the measured part; the thermistor has a B value of 3950 and a resistance of 10KΩ, which can achieve real-time temperature measurement; the pressure measuring wafer and the thermistor are placed in a titanium alloy probe shell with a window on the surface, and are electrically isolated and protected with silicone, and the interface of the sensor is connected to the pressure-temperature acquisition board.

6. The steam ablation needle integrating pressure-temperature non-invasive monitoring function according to claim 1, characterized in that: The tail end of the reducer is provided with an internal thread, and the front end of the PEEK pipe joint is provided with an external thread, and the tail end of the reducer is threadedly connected to the front end of the PEEK pipe joint; the front end outlet of the PEEK pipe joint is flexible and is screwed into the reducer through an external threaded structure, and the reducer has a gradually decreasing inner diameter, and the tail end of the PEEK pipe joint is provided with a connection port between the PEEK pipe joint and the steam transmission stainless steel pipe and a connection port between the PEEK pipe joint and the pressure-temperature monitoring probe; the connection port between the PEEK pipe joint and the steam transmission stainless steel pipe is horizontally arranged, and the connection port between the PEEK pipe joint and the pressure-temperature monitoring probe is obliquely arranged.

Images