CN219021517U

CN219021517U - Flexible sheath tube and combined flexible ablation antenna thereof

Info

Publication number: CN219021517U
Application number: CN202222992734.5U
Authority: CN
Inventors: 欧阳海峰; 陈霞; 王永刚; 孙雪峰
Original assignee: Nanjing Ruibo Medical Technology Co ltd
Current assignee: Nanjing Ruibo Medical Technology Co ltd
Priority date: 2022-11-10
Filing date: 2022-11-10
Publication date: 2023-05-16
Anticipated expiration: 2032-11-10

Abstract

The utility model discloses a flexible sheath and a combined flexible ablation antenna thereof. The flexible sheath tube consists of a guide tube and a grab handle; the guide pipe is internally provided with a water inlet cavity and a water outlet cavity, and a circulating water loop is formed by the guide pipe, a water inlet interface and a water outlet interface on the grab handle. A combined flexible ablation antenna is composed of a flexible ablation antenna and a flexible sheath, wherein the flexible ablation antenna penetrates through the flexible sheath. The flexible ablation antenna consists of a microwave radiation head, a radio frequency coaxial cable, an outer tube and a handle. The radio frequency coaxial cable is connected between the microwave radiation head and the handle, and the outer tube is sleeved outside the microwave radiation head and the radio frequency coaxial cable. The flexible sheath and the flexible ablation antenna can be fixedly combined into a whole. The utility model simplifies the design of the ablation antenna, and the flexible sheath tube and the flexible ablation antenna can be flexibly combined and matched according to the actual use scene, thereby being applicable to microwave ablation under bronchoscope.

Description

Flexible sheath tube and combined flexible ablation antenna thereof

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a flexible sheath and a combined flexible ablation antenna thereof.

Background

Lung cancer is the first place of malignant tumor in incidence and mortality rate in China, wherein GGO is one of important manifestations of early lung cancer, and diseased lung segments or lung lobes are mainly resected through traditional thoracoscopic surgery at present. In recent years, microwave ablation starts to be applied to lung tumor treatment due to the advantages of accuracy and minimally invasive, brings good news to more patients in terms of reducing wounds and surgical risks, sends an ablation antenna to a focus target area through a bronchoscope forceps channel, and can realize noninvasive treatment by implementing microwave ablation treatment.

At present, there is no specific soft ablation needle for pulmonary treatment on the market. The applicant's patent: CN202122791924.6, an outer structural tube for a flexible ablation antenna and a flexible ablation antenna thereof. Although the flexible ablation antenna has good overbending property, the axial pushing force is weak when the flexible ablation antenna is applied to the scene of a certain small-curvature narrow cavity, and occasionally the antenna is bent.

In view of the above, the utility model provides a combined flexible ablation antenna capable of accurately ablating target tissues by means of an ultrasonic imaging system or a CT imaging system to reach a focus position through a natural pulmonary cavity (pulmonary bronchus) under the guidance of a bronchoscope, so that the focus can be accurately reached, accurate treatment is realized, the tolerance of a patient can be improved to the maximum extent, and postoperative complications are reduced.

Disclosure of Invention

The technical scheme of the utility model is as follows:

a flexible sheath tube comprises a guide tube and a grab handle, wherein the guide tube is fixedly connected with the grab handle. The guide tube is entirely through and is used for guiding the flexible ablation antenna. An axial water inlet cavity and a water outlet cavity are arranged between the inner wall and the outer wall of the guide pipe, the distal end of the guide pipe is sealed, the water inlet cavity is communicated with the water outlet cavity at the distal end of the guide pipe, a grab handle is arranged at the proximal end of the guide pipe, the water inlet cavity is communicated with a water inlet interface on the grab handle, and the water outlet cavity is communicated with a water outlet interface on the grab handle. The cooling water is turned back from the water inlet interface to the distal end of the guide tube through the water inlet cavity, flows out from the water outlet interface through the water outlet cavity to form a circulating water loop for cooling the ablation antenna, and can protect the bronchoscope and the pulmonary bronchus tissues of the patient.

The proximal end of the grab handle is provided with a groove or a thread which is matched with the front end of the handle of the flexible ablation antenna and is used for fixedly connecting the flexible sheath tube and the flexible ablation antenna, the flexible sheath tube and the flexible ablation antenna are integrated, and the handle is convenient to hold.

The guide tube is made of flexible materials, and the flexible materials can be medical polymer materials such as polytetrafluoroethylene, polyether-ether-ketone and the like.

The water inlet cavity and the water outlet cavity can be axially arranged in a multi-cavity structure, the structure is uniformly distributed on the circumference of the section of the guide tube, the flexibility of different parts of the sheath tube can be uniform, the flow of circulating water can be increased, and the cooling of the ablation antenna can be rapidly and uniformly realized.

The flexible sheath length L1 is: 1200-2000mm, the external diameter D1 of the flexible sheath is: 1.4-2.5mm.

A combined flexible ablation antenna comprises a flexible sheath and a flexible ablation antenna, wherein the flexible ablation antenna penetrates through the flexible sheath.

The flexible ablation antenna comprises a microwave radiation head, a radio frequency coaxial cable, an outer tube and a handle. The microwave radiation head is positioned at the far end of the flexible ablation antenna, the tail end of the microwave radiation head is provided with a blind hole, the blind hole is electrically connected with the inner conductor of the radio frequency coaxial cable, and the other end of the radio frequency coaxial cable is led out through the radio frequency coaxial cable connector in the handle.

The microwave radiation head is made of medical metal material and is in a blunt solid shape, the external structure of the microwave radiation head is in a shape of big head and small tail, the outer diameter of the tail end of the microwave radiation head is slightly smaller than that of the head, the tail end of the microwave radiation head is sleeved in the outer tube, and the outer diameter of the head of the microwave radiation head is matched with that of the outer tube.

The temperature sensor is positioned between the outer conductor of the radio frequency coaxial cable and the outer tube, the temperature sensor is connected to a sensor signal interface in the handle, and the handle can be connected with a microwave power source and output a temperature signal output by the temperature sensor.

An insulating medium sleeved on the medium layer of the radio frequency coaxial cable is arranged between the tail end of the microwave radiation head and the outer conductor of the radio frequency coaxial cable, the bushing is sleeved on the far end part of the outer conductor of the radio frequency coaxial cable, and the insulating medium and the bushing are both positioned in the outer tube.

The front end of the handle of the flexible ablation antenna is provided with a boss or a thread, and the front end of the handle is fixedly connected with the tail end of the handle of the flexible sheath tube into a whole.

The utility model has the beneficial effects that:

1. simplifying the design of the ablation antenna. Because of microwave radiation, the ablation antenna can generate heat and heat in the using process, and the ablation antenna is generally provided with a cooling water circulation pipeline, as in patent CN202122791924.6 of the applicant, an outer structure pipe for a flexible ablation antenna and the flexible ablation antenna thereof. According to the utility model, a combined mode is adopted to separate the ablation antenna from the cooling water circulation pipeline, so that cooling water circulation is realized in the flexible sheath, the structural design of the ablation antenna is simplified, and the reliability of the ablation antenna is improved.

2. The sheath tube and the ablation antenna which are separated can be combined for use in various specifications, and are suitable for different use scenes. If the microwave radiation heads with different lengths are selected according to different sizes of the focus, the optimal ablation effect is realized. Meanwhile, the sheath tube and the ablation antenna can be fixedly connected and also can be separated for use.

3. The puncture difficulty of the flexible ablation antenna is reduced, and the accuracy and reliability of the puncture process are improved. The ablation antenna is not directly led into the patient, but is indirectly led into the patient through the flexible sheath, so that the ablation antenna is easier to lead.

Drawings

FIG. 1 is a schematic view of a flexible sheath of the present utility model;

FIG. 2 is a cross-sectional view of a guide tube 2 of the flexible sheath of the present utility model;

FIG. 3 is a cross-sectional view of the handle 3 of the flexible sheath of the present utility model;

FIG. 4 is an axial cross-sectional view of the guide tube 2 of the flexible sheath of the present utility model;

FIG. 5 is a schematic diagram of a combined flexible ablation antenna of the utility model;

fig. 6 is a front cross-sectional view of a microwave radiation head according to the present utility model.

Wherein: the microwave radiation device comprises a 1-microwave radiation head, a 2-guiding pipe, a 3-grab handle, a 4-handle, a 5-water outlet interface, a 6-water inlet interface, a 7-inner conductor, an 8-filling medium, a 9-insulating medium, a 10-bushing, an 11-medium layer, a 12-outer conductor, a 13-outer pipe, a 14-water inlet cavity, a 15-water outlet cavity and an 18-temperature sensor.

Detailed Description

The utility model is further described below with reference to the accompanying drawings.

A schematic view of the flexible sheath of the present utility model is shown in fig. 1. The flexible sheath tube comprises a guide tube 2 and a grab handle 3, the grab handle 3 is positioned at the proximal end of the guide tube 2 and fixedly connected with the guide tube 2, and the grab handle 3 is provided with a water inlet interface 6 and a water outlet interface 5. The guiding tube 2 is penetrated all the way through for guiding in the flexible ablation antenna, i.e. the flexible ablation antenna is inserted from the proximal end of the guiding tube 2, and the microwave radiation head is exposed at the distal end of the guiding tube. The length L1 of the flexible sheath tube is 1200-2000mm, and the guide tube 2 is made of flexible materials, such as polyether-ether-ketone or polytetrafluoroethylene. In use, the guide tube 2 can accommodate deformation of a bronchoscope passageway along which it is introduced into patient tissue.

Fig. 2 shows a cross-sectional view of the guide tube 2 of the flexible sheath of the present utility model. Two groups of axial water inlet cavities 14 and water outlet cavities 15 are uniformly distributed between the inner wall and the outer wall of the guide pipe 2 along the circumference, and the water inlet cavities 14 and the water outlet cavities 15 can be uniformly distributed on the circumference of the cross section of the guide pipe 2 by other groups of channels, so that the aim is to increase the circulating water flow while ensuring certain flexibility of the guide pipe 2, and the cooling effect on the melting antenna is ensured.

Figure 3 shows a cross-section of the grip 3 of the flexible sheath of the utility model. The water inlet cavity 14 is communicated with the water inlet interface 6 on the grab handle 3, and the water outlet cavity 15 is communicated with the water outlet interface 5 on the grab handle 3. The cooling water is turned back at the far end of the guide pipe 2 through the water inlet cavity 14 from the water inlet interface 6, flows out from the water outlet interface 5 through the water outlet cavity 15, and forms a circulating water loop. The proximal end of the grab handle 3 may be provided with a groove or a thread, which is matched with the front end of the handle of the flexible ablation antenna, and is used for fixedly connecting the flexible sheath and the flexible ablation antenna, and the flexible sheath and the flexible ablation antenna are integrated, so that the handle is convenient to hold and operate.

Fig. 4 shows an axial cross-section of the guide tube 2 of the flexible sheath of the present utility model. The guiding pipe 2 is communicated in the whole course, a water cavity is arranged between the inner wall and the outer wall, the arrow direction indicates the flowing direction of circulating cooling water, and the water inlet cavity 14 is communicated with the water outlet cavity 15 at the far end of the guiding pipe 2.

Fig. 5 is a schematic diagram of a combined flexible ablation antenna of the utility model. The combined flexible ablation antenna comprises a flexible sheath tube and a flexible ablation antenna, the flexible ablation antenna penetrates through the flexible sheath tube, and the grab handle 3 and the handle 4 are in a separated state. The microwave radiation head 1 is exposed at the distal end of the guide tube 2. The front end of the flexible ablation antenna handle 4 is provided with a boss or a thread, and the front end of the handle 4 and the tail end of the flexible sheath handle 3 can be fixedly connected into a whole by adopting the fit of a groove and the boss or the fit of the thread.

Fig. 6 is a cross-sectional view of the front end of the microwave applicator of the present utility model. The microwave radiation head 1 is made of medical metal materials and is in a blunt shape, the external structure of the microwave radiation head 1 is in a big head and a small tail, the outer diameter of the tail is slightly smaller than that of the head, the tail end of the microwave radiation head 1 is sleeved in the outer tube 13, and the outer diameter of the head of the microwave radiation head 1 is matched with that of the outer tube 13.

An insulating medium 9 sleeved on a medium layer 11 of the radio frequency coaxial cable is arranged between the tail end of the microwave radiation head 1 and an outer conductor 12 of the radio frequency coaxial cable, the insulating medium 9 is used for blocking the electric connection between the microwave radiation head 1 and the outer conductor 12 of the radio frequency coaxial cable, and the insulating medium 9 is a medical high polymer material with good temperature resistance.

The sleeve 10 is looped over the distal portion of the outer conductor 12 of the rf coaxial cable, and the sleeve 10 functions to alter the distribution of microwave radiation energy and thereby alter the morphology of the ablated tissue. The liner 10 is a medical grade metallic material.

A temperature sensor 18 is located between the outer conductor 12 of the radio frequency coaxial cable and the outer tube 13, the signal transmission of the temperature sensor 18 being externally connected through a sensor signal interface within the handle 4. The temperature sensor 18 is used to sense the temperature of the active ablation antenna, which may be a thermocouple or thermistor, etc.

In order to ensure the tightness between the microwave radiation head 1 and the outer tube 13, gaps among the microwave radiation head 1, the outer tube 13 and the outer conductor 12 are filled with a filling medium 8, and the filling medium 8 is a medical polymer material.

The distal end of the outer tube 13 extends to the tail end of the microwave radiation head 1, the length of the outer tube 13 can extend to the handle 4 of the flexible ablation antenna along the radio frequency coaxial cable to wrap the whole radio frequency coaxial cable, the length of the outer tube 13 can be shorter, and the outer conductor 12 of part of the radio frequency coaxial cable can be wrapped. The far end of the outer tube 13 is sleeved on the thin end of the tail part of the microwave radiation head 1, and the matching surface is sealed by high-temperature resistant medical glue.

The microwave radiation head 1 is of a solid structure, and has an outer diameter of 1.2-2.1mm, so that the design can smoothly pass through an endoscope without damaging a mirror. The length L2 of the microwave applicator 1 is 4.5-6mm, so that an optimal ablation pattern can be achieved. The length L3 from the microwave radiation head 1 to the lining 10 is 7-9mm, and the requirement of ablating multiple lesions below 3cm can be met.

The use process of the flexible sheath and the combined flexible ablation antenna in clinical lung ablation is as follows:

the method comprises the steps of determining the focus position through preoperative CT examination, then enabling a bronchoscope to be close to a focus under the assistance of a nurse according to a planned endoscope entering path of a CT image shot by a patient before operation, inserting a flexible sheath tube and a combined flexible ablation antenna thereof into a bronchoscope forceps channel, and inserting the head of the ablation antenna into the focus. Then C-arm CT scanning is used for confirming whether the ablation needle head is inserted into the focus target position or not, after confirming that the microwave ablation antenna is inserted into the focus, the flexible sheath tube and the combined flexible ablation antenna thereof are connected with the microwave ablation instrument through a radio frequency cable and connected with a water pipe; and (3) starting a microwave ablation instrument, opening water circulation, performing microwave ablation operation, and evaluating an ablation result through a CT image and a bronchoscope visual environment after the microwave ablation operation.

The flexible sheath of the present utility model has the following advantages:

1. can enter the target area through the natural cavity of the lung, is safe, noninvasive, good in patient tolerance, low in clinical complications after ablation, good in bending property of an ablation needle and wide in coverage of an ablation area.

2. The focus location is more accurate. The microwave belongs to a single electrode, and the product has the advantages that an needle insertion path is planned by means of an endoscope channel in an electronic navigation mode, the visualization degree is high, and the product can directly reach the focus position under a basically direct-view state.

3. The circulating water is cooled, the rod temperature is low, and the ablation form is more round. The liquid circulation cooling mode is adopted, the clinical operation is more convenient, meanwhile, cooling water is directly led into the sheath tube, the temperature of the whole needle rod is guaranteed not to exceed 40 ℃, the safety of an endoscope and a normal tissue cavity is protected, and the ablation form is closer to an ideal range.

4. A rod temperature monitoring module is arranged. The normal working state of the water circulation system can be guaranteed by monitoring the temperature of the needle bar in real time, the effect of reducing the carbonization of the central area and expanding the ablation range is guaranteed by cooling the needle bar on one hand, the tissue is prevented from being scalded due to the fact that the temperature of the needle bar is too high, and no energy output caused by microwave output faults is prevented on the other hand.

Claims

1. A flexible sheath, characterized by: comprises a guiding pipe (2) and a grab handle (3), wherein the guiding pipe (2) is fixedly connected with the grab handle (3);

the guide tube (2) is communicated in the whole process and used for guiding the flexible ablation antenna, and an axial water inlet cavity (14) and an axial water outlet cavity (15) are arranged between the inner wall and the outer wall of the guide tube (2); the distal end of the guide pipe (2) is sealed, and the water inlet cavity (14) and the water outlet cavity (15) are communicated with each other at the distal end of the guide pipe (2); the grab handle (3) is positioned at the proximal end of the guide pipe (2), the water inlet cavity (14) is communicated with the water inlet interface (6) on the grab handle (3), and the water outlet cavity (15) is communicated with the water outlet interface (5) on the grab handle (3); the cooling water is turned back at the far end of the guide pipe (2) through the water inlet cavity (14) by the water inlet interface (6) and flows out of the water outlet interface (5) through the water outlet cavity (15) to form a water loop.

2. A flexible sheath according to claim 1, wherein: the proximal end of the grab handle (3) is provided with a groove or a thread for fixedly connecting with a handle (4) of the flexible ablation antenna.

3. A flexible sheath according to claim 1 or 2, wherein: the guide tube (2) is made of flexible materials, and the flexible materials are medical polymer materials.

4. A flexible sheath according to claim 3, wherein: the water inlet cavity (14) and the water outlet cavity (15) are axially arranged in multiple cavities and are uniformly distributed on the circumference of the section of the guide pipe (2);

the flexible sheath length L1 is: 1200-2000mm, the sheath outside diameter D1 is: 1.4-2.5mm.

5. A combination flexible ablation antenna, characterized by: comprising the flexible sheath of any one of claims 1-4 and a flexible ablation antenna extending through the flexible sheath;

the flexible ablation antenna comprises a microwave radiation head (1), a radio frequency coaxial cable, an outer tube (13) and a handle (4);

the microwave radiation head (1) is positioned at the far end of the flexible ablation antenna, the tail end of the microwave radiation head is provided with a blind hole, and the blind hole is electrically connected with the inner conductor (7) of the radio frequency coaxial cable; the other end of the radio frequency coaxial cable is led out through a radio frequency coaxial cable connector in the handle (4);

the microwave radiation head (1) is made of medical metal materials, is in a blunt solid shape, adopts a head-to-tail shape with a tail outer diameter slightly smaller than the head outer diameter, is sleeved in the outer tube (13) at the tail end of the microwave radiation head (1), and the head outer diameter of the microwave radiation head (1) is matched with the outer diameter of the outer tube (13).

6. A combined flexible ablation antenna according to claim 5, wherein: a temperature sensor is located between the outer conductor (12) and the outer tube (13) of the radio frequency coaxial cable, the temperature sensor being connected to a sensor signal interface within the handle (4).

7. A combined flexible ablation antenna according to claim 6, wherein: an insulating medium (9) sleeved on a medium layer (11) of the radio frequency coaxial cable is arranged between the tail end of the microwave radiation head (1) and an outer conductor (12) of the radio frequency coaxial cable, a bushing (10) is sleeved on the far end part of the outer conductor (12) of the radio frequency coaxial cable in a ring mode, and the insulating medium (9) and the bushing (10) are both positioned in the outer tube (13).

8. A combined flexible ablation antenna according to claim 7, wherein: the front end of the flexible ablation antenna handle (4) is provided with a boss or a thread, and the front end of the handle (4) is fixedly connected with the tail end of the flexible sheath handle (3) into a whole.