Steam ablation needle with tissue near infrared spectrum noninvasive measurement function

Abstract

The steam ablation needle with the tissue near infrared spectrum noninvasive measurement function comprises an ablation needle head, a hole is formed in the front end of the ablation needle head, the tail end of the ablation needle head is fixedly connected with a double-layer stainless steel vacuum tube, and the other end of the double-layer stainless steel vacuum tube is fixedly connected with the head end of a reducer union; the tail end of the reducer union is fixedly connected with the front end of the PEEK pipe joint, the tail portion of the PEEK pipe joint is connected with the steam transmission stainless steel pipe, one end of the steam transmission stainless steel pipe is connected into the PEEK pipe joint, and the other end of the steam transmission stainless steel pipe is connected with the steam generator. One end of the Y-shaped near-infrared optical fiber penetrates out of a hole in the front end of the ablation needle head, and the other end of the Y-shaped near-infrared optical fiber penetrates out of the tail end of the PEEK tube connector. While steam ablation is achieved, the tissue protein solidification degree of the ablation center can be monitored in real time.

Description

Technical Field

[0001] The invention relates to the technical field of thermal ablation, in particular to a steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function. Background Art

[0002] As one of the determining factors of cell inactivation, temperature cannot accurately reflect the degree of tissue ablation. Thermal damage to biological tissues under thermal ablation is a dynamic process related to temperature and time. It is essentially a process in which proteins denature and gradually coagulate during the ablation process. The near-infrared optical parameters of biological tissues (reduced scattering coefficient, absorption coefficient, blood oxygen saturation, etc.) also change dynamically with the changes in cell morphology and protein tertiary structure during the gradual coagulation of tissues due to thermal damage, and can be used as an evaluation indicator for the degree of steam thermal ablation.

[0003] The current near-infrared optical fiber cannot be integrated with microwave ablation needles, radiofrequency ablation needles, and laser ablation needles. Therefore, the use of Y-shaped near-infrared optical fiber to monitor tissue near-infrared optical parameters during the current microwave, radiofrequency, and laser thermal ablation processes requires puncturing the fiber probe into different positions of the ablation area to obtain the near-infrared spectrum of the tissue in real time and calculate the corresponding optical parameters. Although this method provides a means of monitoring ablation conditions to a certain extent, it has many limitations in practical applications. First, additional punctures not only increase the patient's pain and body damage, but may also cause infection; second, the puncture process will be affected by various factors and deviate from the predetermined target, and the degree of cell inactivation in the ablation center area cannot be accurately assessed.

[0004] The reduced scattering coefficient in the near-infrared optical parameters can characterize the degree of tissue protein coagulation. Our research has shown that when the reduced scattering coefficient is >15cm -1 When the ablation state is 100%, the tissue proteins are completely coagulated and the cells are completely inactivated. Therefore, the ablation state can be evaluated by evaluating the reduced scattering coefficient of the central area.

[0005] Therefore, there is an urgent need to design a steam ablation needle with non-invasive tissue near-infrared spectroscopy measurement function, which can accurately evaluate the degree of protein coagulation at the central target of ablation while performing thermal ablation. Summary of the invention

[0006] The purpose of the present invention is to provide a steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function, which can obtain the near-infrared optical parameters of the tissue during thermal ablation to accurately evaluate the degree of protein coagulation at the ablation center target.

[0007] To achieve the above object, the present invention adopts the following technical solution:

[0008] A steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function, comprising an ablation needle, a double-layer stainless steel vacuum tube, a reducer, a PEEK pipe joint, a Y-shaped near-infrared optical fiber, a steam transmission stainless steel tube, and a rubber insulation tube sleeve, wherein: the front end of the ablation needle has an opening, the tail end is fixedly connected to the double-layer stainless steel vacuum tube, the other end of the double-layer stainless steel vacuum tube is fixedly connected to the head end of the reducer, the tail end of the reducer is fixedly connected to the front end of the PEEK pipe joint, the tail end of the PEEK pipe joint is connected to the steam transmission stainless steel tube, and the steam transmission One end of the stainless steel tube is connected to the inside of the PEEK pipe joint, and the other end is connected to the steam generator. The rubber insulation tube sleeve is wrapped around the outer wall of the steam transmission stainless steel tube. The ablation needle, double-layer stainless steel vacuum tube, reducer, PEEK pipe joint, and steam transmission stainless steel tube are all hollow and interconnected. The Y-shaped near-infrared optical fiber is located in the cavity inside the ablation needle, double-layer stainless steel vacuum tube, reducer, and PEEK pipe joint. One end of the Y-shaped near-infrared optical fiber passes through the hole at the front end of the ablation needle, and the other end passes through the tail end of the PEEK pipe joint.

[0009] Preferably, the ablation needle includes a puncture needle tip and a puncture needle rod, the puncture needle tip is a hollow frustum, and the puncture needle rod is a hollow cylinder; the head of the puncture needle tip is provided with an optical fiber outlet, and the puncture needle rod is provided with a plurality of steam outlets around it.

[0010] Preferably, the optical fiber outlet of the puncture needle tip is a circular hole with a diameter of 1 mm.

[0011] Preferably, the steam outlets around the puncture needle rod are evenly distributed. In the axial direction of the puncture needle rod, 15 steam outlets are opened 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 opened in a circle, and the spacing between adjacent holes is 45°; the diameter of each steam outlet is 0.2 mm.

[0012] Preferably, the total length of the ablation needle is 28 mm, the outer diameter of the puncture needle shaft is 1.5 mm, and the inner diameter is 1.2 mm.

[0013] Preferably, the Y-shaped near-infrared optical fiber is CCS200H-6T-7B-1.5 multi-core cable optical fiber with a total length of 15 cm, an outer diameter of 0.9 mm, a transmittance (λ=632.8 nm) of 78% to 84%, and a core diameter / optical window size of 200 um.

[0014] Preferably, the tail end of the reducer is provided with an internal thread, 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 the PEEK pipe joint is screwed into the reducer through its external threaded structure, and the reducer has a gradually decreasing inner diameter.

[0015] Preferably, the tail end of the PEEK pipe joint is provided with a PEEK pipe joint-steam transmission stainless steel pipe connection port and a PEEK pipe joint-optical fiber connection port; the PEEK pipe joint-steam transmission stainless steel pipe connection port is horizontally arranged, and the PEEK pipe joint-optical fiber connection port is obliquely arranged.

[0016] Preferably, a layer of anti-sticking material is coated on the outer surface of the double-layer stainless steel vacuum tube and the reducer.

[0017] Preferably, the double-layer stainless steel vacuum tube consists of an outer tube and an inner tube, the outer tube has an outer diameter of 2.1 mm, the inner tube has an inner diameter of 1.3 mm, the interlayer between the outer tube and the inner tube is vacuum, both ends of the interlayer are sealed, and the inner tube protrudes 1 mm outside.

[0018] Beneficial effects: The steam ablation needle of the present invention has the function of non-invasive measurement of tissue near-infrared spectrum. While performing ablation using hot steam, it strictly controls the ablation situation in the center of the ablation zone to prevent the occurrence of carbonization. Compared with the prior art, it has the following advantages: (1) The multi-row and multi-column steam outlets designed at the needle tip of the present invention can evenly transmit the steam to avoid excessive accumulation of heat at a single point, making the heat transfer more uniform and the effective ablation range larger. (2) The steam ablation needle of the present invention integrates the near-infrared optical parameter monitoring function. It can monitor the protein coagulation degree in the ablation center area in real time without inserting a Y-shaped near-infrared optical fiber probe. When the reduced scattering coefficient value of the central area is close to the carbonization threshold, the steam output parameters can be adjusted in time to prevent carbonization. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the cross-sectional structure of a steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function according to the present invention;

[0020] Figure 2 It is a schematic structural diagram of a steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function according to the present invention;

[0021] Figure 3 is a schematic diagram of the structure of the ablation needle;

[0022] Figure 4 It is a structural schematic diagram of a PEEK pipe joint;

[0023] Figure 5 It is a steam ablation system with the function of non-invasive measurement of tissue near-infrared spectrum;

[0024] In the figure, 1-ablation needle, 2-double-layer stainless steel vacuum tube, 3-reducing joint, 4-PEEK pipe joint, 5-Y-type near-infrared optical fiber, 6-steam transmission stainless steel tube, 7-rubber insulation tube sleeve, 11-puncture needle tip, 12-puncture needle rod, 111-optical fiber outlet, 121-steam outlet, 41-PEEK pipe joint-steam transmission stainless steel tube connection port, 42-PEEK pipe joint-optical fiber connection port;

[0025] 10- pig liver, 20- steam ablation needle, 30- Y-type near-infrared optical fiber transmission line, 40- spectrometer, 50- transmission line between spectrometer and host computer, 60- host computer, 70- solid-state light source, 80- steam transmission tube, 90- steam generator, 100- transmission line between steam generator and host computer. DETAILED DESCRIPTION

[0026] The present invention will be further explained below in conjunction with the accompanying drawings.

[0027] like Figure 1 and Figure 2 As shown, a steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function of the present invention comprises an ablation needle 1, a double-layer stainless steel vacuum tube 2, a reducer 3, a PEEK pipe joint 4, a Y-shaped near-infrared optical fiber 5, a steam transmission stainless steel tube 6, and a rubber insulation tube sleeve 7, wherein: the front end of the ablation needle 1 is opened, the tail end is fixedly connected to 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 end of the reducer 3, the tail end of the reducer 3 is fixedly connected to the front end of the PEEK pipe joint 4, the tail end of the PEEK pipe joint 4 is connected to the steam transmission stainless steel tube 6, one end of the steam transmission stainless steel tube 6 is connected to the inside of the PEEK pipe joint 4, and the other end is connected to the steam generator, and the rubber insulation tube sleeve 7 is wrapped around the outer wall of the steam transmission stainless steel tube 6 to prevent the loss of steam heat. The ablation needle 1, the double-layer stainless steel vacuum tube 2, the reducer 3, the PEEK tube joint 4, and the steam transmission stainless steel tube 6 are all hollow and interconnected. The Y-shaped near-infrared optical fiber 5 is located in the cavity inside the ablation needle 1, the double-layer stainless steel vacuum tube 2, the reducer 3, and the PEEK tube joint 4. One end of the Y-shaped near-infrared optical fiber 5 passes through the hole at the front end of the ablation needle 1, and the other end passes through the rear end of the PEEK tube joint 4.

[0028] like Figure 3 As shown, the ablation needle 1 includes a puncture needle tip 11 and a puncture needle rod 12. The puncture needle tip 11 is a hollow frustum, and the puncture needle rod 12 is a hollow cylinder. The head of the puncture needle tip 11 is provided with an optical fiber outlet 111 for extending the head of the Y-shaped near-infrared optical fiber 5 therefrom, and the puncture needle rod 12 is provided with a plurality of steam outlets 121 around it.

[0029] The optical fiber outlet 111 at the head of the puncture needle tip 11 is a circular hole with a diameter of 1 mm.

[0030] The steam outlets 121 around the puncture needle rod 12 are evenly distributed. In the axial direction of the puncture needle rod 12, 15 steam outlets 121 are opened in a row, and the distance between adjacent holes is 0.2mm. In the circumferential direction of the puncture needle rod 12, 8 steam outlets 121 are opened in a circle, and the interval between adjacent holes is 45°; the diameter of each steam outlet 121 is 0.2mm.

[0031] The formation of ablation areas of different sizes can be achieved by modifying the size of the openings and the hole spacing of the puncture needle shaft 12 .

[0032] The total length of the ablation needle 1 is 28 mm, and the outer diameter of the puncture needle shaft 12 is 1.5 mm and the inner diameter is 1.2 mm.

[0033] The Y-shaped near-infrared optical fiber 5 uses CCS200H-6T-7B-1.5 multi-core cable optical fiber with a total length of 15 cm, an outer diameter of 0.9 mm, a transmittance (λ=632.8 nm) of 78% to 84%, and a core diameter / optical window size of 200 um.

[0034] The tail end of the reducer 3 is provided with an internal thread, and the front end of the PEEK pipe joint 4 is provided with an external thread. The tail end of the reducer 3 is threadedly connected with the front end of the PEEK pipe joint 4, which is convenient for postoperative inspection and parts disassembly and replacement.

[0035] The tail end of the PEEK pipe joint 4 is provided with a PEEK pipe joint-steam transmission stainless steel pipe connection port 41 and a PEEK pipe joint-optical fiber connection port 42; the PEEK pipe joint-steam transmission stainless steel pipe connection port 41 is horizontally arranged, and the PEEK pipe joint-optical fiber connection port 42 is obliquely arranged.

[0036] The outer surfaces of the double-layer stainless steel vacuum tube 2 and the reducer 3 are coated with a layer of anti-sticking material.

[0037] The double-layer stainless steel vacuum tube 2 consists of an outer tube and an inner tube. The outer diameter of the outer tube is 2.1 mm, and the inner diameter of the inner tube is 1.3 mm. The interlayer between the outer tube and the inner tube is vacuum, and both ends of the interlayer are sealed. The inner tube protrudes 1 mm to facilitate assembly and welding with the ablation needle 1.

[0038] The materials used for the ablation needle, double-layer stainless steel vacuum tube, reducer and air intake stainless steel tube are 304 medical stainless steel.

[0039] The front outlet of the PEEK fitting is made of flexible material, and the PEEK fitting is screwed into the reducer through its external thread structure. This reducer is designed with a gradually decreasing inner diameter to match and guide the flexible front outlet of the PEEK fitting. As the threads are gradually tightened, the flexible front end of the PEEK fitting is compressed and pushed deeper into the reducer, and its outlet diameter is gradually reduced accordingly. This design achieves an efficient, reliable and airtight fit between the PEEK fitting and the steam transmission stainless steel pipe, improves the overall sealing performance of the system, simplifies the installation process, and reduces maintenance costs.

[0040] The heat-insulating pipe sleeve is made of rubber material, which is resistant to high temperature, flexible and aging-resistant. It can protect the inner layer of the steam transmission stainless steel pipe from loss, while ensuring that heat is not lost as much as possible during steam transmission. At the same time, the pipe sleeve can still maintain stable performance in a high temperature environment, greatly extending its service life.

[0041] The double-layer stainless steel vacuum tube 2 is fixed to the ablation needle 1 and the reducer 3 by welding. The reducer 3 and the PEEK pipe joint 4 are fixed by threads, and raw tape is inserted between the threads to prevent water leakage. The PEEK4 pipe joint and the Y-shaped near-infrared optical fiber 5 are fixed by organic silicone gel and raw tape. The PEEK pipe joint 4 and the steam transmission stainless steel pipe 6 are fixed by organic silicone gel and raw tape.

[0042] When connecting the PEEK pipe joint and the steam transmission stainless steel pipe, the PEEK pipe joint and the Y-shaped near-infrared optical fiber, and the steam transmission stainless steel pipe and the steam generator, in order to ensure that there is no steam leakage under high pressure conditions, it is necessary to use raw tape and silicone gel to seal the PEEK pipe joint and the screw hole at the steam generator outlet. The raw tape will expand when in contact with steam to ensure air tightness; the silicone gel can fix the raw tape to ensure that the raw tape does not produce lateral displacement along the air inlet pipe.

[0043] High-temperature water vapor is injected from the steam transmission stainless steel tube 6, transmitted along the double-layer stainless steel vacuum tube 2, and reaches the steam outlet 12 to ablate the tissue.

[0044] The method of using the steam ablation needle with tissue near infrared spectrum non-invasive measurement function of the present invention is as follows:

[0045] First assemble as Figure 5The steam ablation system with tissue near infrared spectrum non-invasive measurement function shown in the figure comprises: pig liver 10, steam ablation needle 20, Y-shaped near infrared optical fiber transmission line 30, spectrometer 40, transmission line between spectrometer and host computer 50, host computer 60, solid-state light source 70, steam transmission tube 80, steam generator 90, and transmission line between steam generator and host computer 100. Before ablation begins, the steam ablation needle 2 is punctured into the tissue of pig liver 1 and waits for ablation. The host computer 10 can control the steam generator 9 to generate high-temperature water vapor, which reaches the ablation needle 2 from the steam transmission tube 8. The Y-shaped near-infrared optical fiber transmission line 3 is divided into two, an incident optical fiber and a reflective optical fiber: the solid-state light source 7 can emit light, which is transmitted from the incident optical fiber to the center of the ablated tissue, and then a reflected light is generated by the tissue state of the ablation center. The reflected light is transmitted to the spectrometer 4 through the reflective optical fiber for spectral analysis. The obtained spectral signal is transmitted to the host computer 6 by the spectrometer and the host computer transmission line 5, which can be used for analysis and recording by the experimenter. By analyzing the infrared spectrum of the tissue, the ablation state of the central tissue of the ablation zone can be known.

[0046] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A steam ablation needle with a tissue near-infrared spectrum non-invasive measurement function, characterized in that: The invention comprises an ablation needle (1), a double-layer stainless steel vacuum tube (2), a reducer (3), a PEEK pipe joint (4), a Y-shaped near-infrared optical fiber (5), a steam transmission stainless steel tube (6), and a rubber heat-insulating tube sleeve (7), wherein: the front end of the ablation needle (1) is opened, the rear end is fixedly connected to 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 front end of the reducer (3), the rear end of the reducer (3) is fixedly connected to the front end of the PEEK pipe joint (4), the rear end of the PEEK pipe joint (4) is connected to the steam transmission stainless steel tube (6), and one end of the steam transmission stainless steel tube (6) is connected to the PEEK pipe joint (4). The inner part of the Y-shaped near-infrared optical fiber (5) is located in the cavity inside the ablation needle (1), the double-layer stainless steel vacuum tube (2), the reducer (3), the PEEK tube joint (4), and the PEEK tube joint (4). One end of the Y-shaped near-infrared optical fiber (5) passes through the hole at the front end of the ablation needle (1), and the other end passes through the rear end of the PEEK tube joint (4).

2. The steam ablation needle with tissue near-infrared spectrum non-invasive measurement function according to claim 1, characterized in that: The ablation needle (1) comprises a puncture needle tip (11) and a puncture needle rod (12); the ablation needle (1) has a total length of 28 mm, the puncture needle tip (11) is a hollow truncated cone, and the puncture needle rod (12) is a hollow cylinder with an outer diameter of 1.5 mm and an inner diameter of 1.2 mm; the head of the puncture needle tip (11) is provided with an optical fiber outlet (111), and the optical fiber outlet (111) is a circular hole with a diameter of 1 mm; uniformly distributed steam outlets (121) are provided around the puncture needle rod (12); in the axial direction of the puncture needle rod (12), 15 steam outlets (121) are provided in a row, and the spacing between adjacent holes is 0.2 mm; in the circumferential direction of the puncture needle rod (12), 8 steam outlets (121) are provided in a circle, and the spacing between adjacent holes is 45°; the diameter of each steam outlet (121) is 0.2 mm.

3. The steam ablation needle with tissue near-infrared spectrum non-invasive measurement function according to claim 1, characterized in that: The Y-shaped near-infrared optical fiber is CCS200H-6T-7B-1.5 multi-core cable optical fiber with a total length of 15 cm, an outer diameter of 0.9 mm, a transmittance (λ=632.8 nm) of 78% to 84%, and a core diameter / optical window size of 200 um.

4. The steam ablation needle with tissue near-infrared spectrum non-invasive measurement function according to claim 1, characterized in that: The tail end of the reducer (3) is provided with an internal thread, the front end of the PEEK pipe joint (4) is provided with an external thread, and the tail end of the reducer (3) is threadedly connected to the front end of the PEEK pipe joint (4); the front end outlet of the PEEK pipe joint (4) is flexible, and the PEEK pipe joint (4) is screwed into the reducer (3) through its external thread structure, and the reducer (3) has a gradually decreasing inner diameter; the tail end of the PEEK pipe joint (4) is provided with a PEEK pipe joint-steam transmission stainless steel pipe connection port (41) and a PEEK pipe joint-optical fiber connection port (42); the PEEK pipe joint-steam transmission stainless steel pipe connection port (41) is horizontally arranged, and the PEEK pipe joint-optical fiber connection port (42) is obliquely arranged.

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