CN214104598U

CN214104598U - Electrotome for treating nodules in airway

Info

Publication number: CN214104598U
Application number: CN202022048206.5U
Authority: CN
Inventors: 徐宏; 秦翔翔; 王耀辉; 叶亚彬
Original assignee: Hangzhou Kunbo Biotechnology Co Ltd
Current assignee: Hangzhou Kunbo Biotechnology Co Ltd
Priority date: 2020-09-17
Filing date: 2020-09-17
Publication date: 2021-09-03
Anticipated expiration: 2030-09-17

Abstract

The application provides an electrotome for treating nodules in an airway, which comprises a tube body and electrodes which are connected with each other, wherein the tube body is provided with a far end and a near end which are opposite to each other, and a smoke exhaust hole is formed in the side wall of the tube body adjacent to the far end; the electrode includes: the connecting pipe comprises an internal section fixedly embedded in the pipe body and an external section extending out of the pipe body, the internal section is provided with a hollow area, and the length of the part with the hollow area is at least 3 cm; and the discharge head is connected to the external section and seals the far-end opening of the external section. The utility model provides an electrotome conveniently treats interior knot of air flue, and can reduce the electrode risk of droing.

Description

Electrotome for treating nodules in airway

Technical Field

The application relates to the technical field of medical equipment, in particular to an electrotome for treating nodules in an airway.

Background

An intraairway nodule is an abnormal structure or diseased tissue of the trachea, bronchi or lungs. There are many possible diagnostic outcomes for nodules affected by CT, most of which do not require treatment nor surgery for benign nodules, and for malignant or malignant-prone lung nodules, surgical resection is required in time to avoid progression and deterioration. In clinical treatment, surgery is a common option, such as an open chest lung resection. However, if the diseased portion of the lung is removed by surgery, surgery typically results in a reduction in the effective lung volume of about 15-30%, which may not be sufficient to cause a significant increase in lung function. Meanwhile, lung cancer patients with older age, weak constitution, poor heart and lung functions or complications are not suitable for or tolerant to conventional surgical resection therapy.

The principle of the radio frequency ablation is that alternating high-frequency current with the frequency less than 30MHz (generally 460-480 kHz) is applied to enable ions in tumor tissues to generate high-speed oscillation and mutual friction, radio frequency energy is converted into heat energy, and therefore coagulative necrosis of tumor cells occurs.

In radiofrequency ablation therapy, the device used is an electrotome, the distal electrode of which is capable of transmitting radiofrequency energy to the tissue surrounding the site of penetration after percutaneous penetration. In the operation process, the phenomenon of electrode falling happens occasionally.

SUMMERY OF THE UTILITY MODEL

The application provides an electrotome, conveniently treats interior knot of air flue, and can reduce the electrode risk of droing.

The electrotome for treating the nodules in the airway comprises a tube body and electrodes which are connected with each other, wherein the tube body is provided with a far end and a near end which are opposite to each other, and a smoke exhaust hole is formed in the side wall of the tube body, which is close to the far end; the electrode includes:

the connecting pipe comprises an internal section fixedly embedded in the pipe body and an external section extending out of the pipe body, the internal section is provided with a hollow area, and the length of the part with the hollow area is at least 3 cm;

and the discharge head is connected to the external section and seals the far-end opening of the external section.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the built-in section is of a spiral band structure, and a gap between adjacent circles of the spiral band is used as the hollow area.

Optionally, the length of the part with the hollow area in the built-in section is 5-8 cm.

Optionally, the position of the smoke discharge hole corresponds to the position of the hollow-out area of the built-in section.

Optionally, a plurality of smoke discharge holes are arranged along the length direction of the pipe body.

Optionally, the arrangement mode of the smoke discharge holes is matched with the shape of the hollowed-out area.

Optionally, the discharge head and the connecting pipe are detachably connected or welded and fixed.

Optionally, the discharge head sequentially includes, from the proximal end to the distal end:

the connecting section is connected to the far-end part of the external section;

the conical section, the conical tip position of conical section has the transition cambered surface.

Optionally, a limit step abutting against the distal end face of the external section is arranged between the connecting section and the conical section.

Optionally, the connecting section is inserted into the external section, and the outer peripheral surface of the limiting step is flush with the outer peripheral surface of the external section.

The utility model provides an electrotome conveniently treats interior knot of air flue, and can reduce the electrode risk of droing.

Drawings

FIG. 1 is a schematic diagram of an embodiment of an electrotome system of the present application for treating nodules in the airway;

FIG. 2 is an internal block diagram of one embodiment of the electrotome of the present application for treating nodules in the airway;

FIG. 3 is an exploded view of an embodiment of the electrotome of the present application for treating nodules in the airway;

FIG. 4 is an enlarged view of area A of FIG. 2;

FIG. 5 is an enlarged view of area B of FIG. 3;

FIG. 6 is an internal structural view of the operating handle of FIG. 1;

fig. 7 is a schematic diagram of an embodiment of an electrotome with a sharpened tip for treating nodules in the airway.

The reference numerals in the figures are illustrated as follows:

1. a pipe body; 11. a first sheath tube; 12. a second sheath; 2. an electrode; 21. a connecting pipe; 211. a built-in section; 212. an external section; 22. a discharge head; 221. a connecting section; 222. a tapered section; 223. a transition arc surface; 224. a limiting step; 23. cutting a tip part; 24. puncturing the inclined plane; 3. a smoke vent; 4. an operating handle; 41. a first support housing; 42. a second support housing; 5. a wire; 6. a pipeline interface; 7. banana connectors.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

In the prior art, the top electrode of the electrotome for treating the nodules in the airway adopts a simple cylindrical structure, and the connection length between the top electrode and the tube body is limited.

The inventors found that the connection strength between the electrode and the tube body was insufficient, and the electrode was likely to fall off during use of the electric knife.

As shown in fig. 1, 2, 3 and 4, the electrotome for treating nodules in the airway comprises a tube body 1 and an electrode 2 which are connected with each other, wherein the tube body 1 has a distal end (an end close to the patient, such as the end indicated by an arrow X in fig. 1) and a proximal end (an end close to the operator) which are opposite, and the tube body 1 is provided with a smoke discharge hole 3 on the side wall near the distal end. The electrode 2 includes a connection tube 21 and a discharge head 22.

The connecting pipe 21 comprises an internal section 211 fixedly embedded in the pipe body 1 and an external section 212 extending out of the pipe body 1, wherein the internal section 211 is provided with a hollow area, and the length of the part with the hollow area is at least 3 cm. The discharge head 22 is connected to the outer section 212 and closes the distal opening of the outer section 212.

The external section 212 and the tube body 1 which is not coated with the insulating material at the periphery of the discharge head 22 can be close to the nodule in the airway, radio frequency energy is released to the nodule tissue, and the radio frequency energy is absorbed by the tissue in the forms of ohmic loss and dielectric loss, so that the temperature of the nodule part is increased. When the temperature of the nodule reaches 45-50 ℃, protein in cells can be denatured, double-layer lipid membranes are dissolved, cell membranes are cracked, and meanwhile, water inside and outside the cells is lost, so that tissue necrosis is caused.

The outer periphery of the built-in section 211 is coated with the tube body 1 made of insulating materials, and impedance between the tube body and surrounding tissues is large, so that radio frequency energy is guaranteed to be concentrated at the external section 212 and the discharge head 22, and a controllable ablation focus is formed. In the embodiment, the connection strength between the tube body 1 and the electrode 2 is increased by prolonging the length of the built-in section 211 (the length of the built-in section is greater than the length of the hollow-out section is greater than 3cm), and the influence on the effective power (the part of the output power of the ablation instrument which directly causes the tissue heating reaction) is small.

Specifically, in the radial direction (perpendicular to the extending direction of the pipe body 1), the outer peripheral surface of the built-in section 211 in the present embodiment is covered with the pipe body 1, and the inner peripheral surface of the built-in section 211 may be covered with the inner wall of the pipe body 1 or may be exposed to the inside of the pipe body 1. The built-in section 211 in this embodiment mainly serves as a mechanical structure, and plays a role in reinforcing and supporting the pipe body 1 and connecting the pipe body 1.

Another effect of increasing the length of the built-in section 211 is to leave sufficient axial space for machining the hollowed-out area. Due to the arrangement of the hollow-out area, on one hand, the bending strength of the built-in section 211 is reduced, and even if the built-in section 211 is prolonged, the fact that the compliance of the far end of the electrotome is obviously affected is not worried.

On the other hand, the tube body 1 or the bonding material between the tube body 1 and the electrode 2 can be filled into the hollow area along the radial direction, and interfere with the axial extraction path of the electrode 2. Therefore, when the electrode 2 is pulled, not only the chemical bond force and the friction force between the peripheral surface of the electrode 2 and the tube body 1 are overcome, but also the larger mechanical embedding force is overcome, and the risk of falling of the electrode is greatly reduced.

Referring to fig. 2, the tube 1 includes multiple sheath tubes sequentially butted from the proximal end to the distal end, and the elastic modulus of each sheath tube is gradually decreased, wherein the sheath tube at the distal end is the first sheath tube 11, and the built-in section 211 extends to the proximal end of the first sheath tube 11. Specifically, in one embodiment, the distance between the inner segment 211 and the proximal end surface of the first sheath 11 is 0-10 mm.

The sheath near the proximal end is relatively hard, the control stability is good, and the electrode 2 is convenient to be sent to the focus position. The sheath close to the far end is relatively soft and easy to deform, the control flexibility is good, the fitting posture of the electrode 2 and nodules in the air flue is easy to adjust, and the sheath is suitable for focus environments in different forms. The electrode 2 may be made of various materials such as conductive polymer, conductive ceramic, and metal. When the electrode 2 is made of metal, the built-in section 211 is used as a lining or a framework, so that the thermal stability of the structure at the first sheath 11 can be increased.

As shown in fig. 2, the proximal side of first sheath 11 is second sheath 12, and built-in section 211 extends into second sheath 12. The first sheath 11 and the second sheath 12 made of different materials may be directly bonded or thermally fused at end surfaces, and the contact area of the connection portions is small. Specifically, in one embodiment, the first sheath 11 has a hardness of 55D, and the second sheath 12 has a hardness of 72D. In this embodiment, another connection form is provided, and both the first sheath 11 and the second sheath 12 are connected to the peripheral surface of the built-in section 211, and the contact area of the connection portions is larger and is firmer.

Further, the inner segment 211 is located inside the first sheath 11 as a first connecting segment, which is L1 in length; the connecting part is positioned in the second sheath 12 and is a second connecting section, and the length of the second connecting section is L2; and the L1 is 3-10 times of the L2, so that the length of the second connecting section can ensure higher connecting strength without obviously changing the bending performance of the second sheath tube 12.

In order to prevent the inner wall of the built-in section 211 from contacting with the body fluid of the human body, reduce scab in the pipeline, and improve the utilization rate of the radio frequency energy, as shown in fig. 4, the built-in section 211 is fixed in the pipe wall of the pipe body 1 in a hot melting manner and is completely wrapped by the pipe wall. Specifically, the electrode 2 can be pre-embedded in the cavity when the tube body 1 is molded, the tube body 1 which is molded respectively can be sleeved outside the electrode 2, a core rod is added in the electrode 2 for supporting, and the whole body is heated to form the electrode. When the pipe wall material continuously distributed tubular structure is bent, the inner side and the outer side of the bent portion bear compressive stress and tensile stress respectively, the shape and the distribution of the hollow areas are reasonably arranged, so that the bending stress can be effectively reduced, and the pipe body is allowed to be bent at least through the distribution of the hollow areas.

As shown in fig. 5, the built-in section 211 is a spiral band structure, and a gap between adjacent turns of the spiral band is used as a hollow-out area.

The spiral belt structure has good elastic deformation capacity, stress generated when the built-in section 211 is bent can be reduced, and radial support strength of the pipe body 1 can be guaranteed.

For convenient processing, the internal section 211 and the external section 212 are formed by integrally cutting pipes. Specifically, the ribbon has a width of M1, and the gap between adjacent turns of the ribbon has a width of M2, and satisfies M2>0.5 × M1.

As shown in FIG. 2, the length of the part with the hollow-out area in the built-in section is 5-8 cm.

The band width M1 of the spiral band is 1.2-3.5 mm, and the gap width M2 is 1-1.7 times of the band width M1 of the spiral band. The lift angle alpha of the spiral belt is 10-20 degrees.

The thickness of the spiral belt is 1/7-1/4 of the thickness of the pipe body 1. The appropriate wall thickness of the spiral belt and the combined belt width can ensure the connection strength and also can take compliance and supporting force into consideration.

The helical band is close to the inner circumferential surface of the pipe body 1 in the radial direction of the pipe body 1. Specifically, the distance between the ribbon and the inner circumferential surface of the tube 1 is D1, the distance between the ribbon and the outer circumferential surface of the tube 1 is D2, and D2 is 5 to 9 times of D1.

As shown in fig. 4, the position of the smoke discharge hole 3 corresponds to the position of the hollow area (e.g., the area sandwiched by the two dotted lines in fig. 4) of the built-in section 211.

Specifically, along the length direction of the pipe body 1, the smoke discharge holes 3 are at least partially overlapped with the hollow areas, so that smoke generated by ablation can enter the pipe body 1 through the smoke discharge holes 3 and the hollow areas in sequence, and the smoke is discharged outside the body under the condition that power is applied to the outside (for example, the near end of the pipe body 1 is connected with a vacuum pump).

As shown in FIG. 2, a plurality of smoke discharge holes 3 are arranged along the longitudinal direction of the pipe body 1.

Under the same flue gas removal flow, the pressure difference between the inside and the outside of the pipe body 1 can be reduced by increasing the number of the smoke discharge holes 3, and the position change of the electrode 2 relative to the node part caused by the distortion of the pipe body 1 during the exhaust is prevented.

As shown in fig. 2, the arrangement of the smoke discharge holes 3 is matched with the shape of the hollow-out area.

When the shape of the hollow-out area is spiral, the plurality of smoke discharge holes 3 are arranged in a spiral mode.

In order to increase the number of the smoke exhaust holes 3 while ensuring the radial support strength of the pipe body, a plurality of smoke exhaust holes 3 arranged along the length direction of the pipe body 1 are a group, and a plurality of groups of smoke exhaust holes 3 are arranged along the circumferential direction of the pipe body 1. In order to ensure that the strength of the pipe body part corresponding to the hollowed-out areas is uniformly distributed in the length direction, the smoke exhaust holes 3 and the hollowed-out areas are uniformly arranged along the length direction, and the distance between every two adjacent rows of smoke exhaust holes 3 is matched with the distance between every two adjacent hollowed-out areas.

The discharge head 22 is detachably connected or welded to the connection pipe 21.

The detachable connection is such as plug-in connection, threaded connection and the like, after the discharge head 22 is detached, the sectional area of the far end of the electrode is reduced, the radio frequency energy is concentrated, and the electrode can be used for cutting pathological tissues. The discharge head 22 and the connecting pipe 21 are welded and fixed, so that the connection strength is guaranteed.

As shown in fig. 4, the discharge head 22 includes a connecting section 221 and a tapered section 222 in this order from the proximal end to the distal end. The connecting section 221 is connected to a distal portion of the external section 212. The conical tip of the conical section 222 has a transition arc 223.

The size of the transition arc 223 is adapted to the size of the nodule, so that the normal tissue can be prevented from being scratched while a sufficiently large ablation range is obtained.

A limit step 224 which is abutted against the distal end face of the external section 212 is arranged between the connecting section 221 and the conical section 222.

The axial sliding of the discharge head 22 relative to the outer positioned section 212 is further limited by the limit step 224.

The connecting section 221 is inserted into the external section 212, and the outer peripheral surface of the limiting step 224 is flush with the outer peripheral surface of the external section 212.

The limit step 224 is abutted against the far end of the external section 212, so that no obvious gap exists at the connecting part of the limit step and the external section in the axial direction. The two are flush with each other on the outer peripheral surface of the connecting part, so that steps caused by radial size difference are further avoided, and finally the purpose of preventing the connecting part of the discharge head 22 and the external section 212 from scratching tissues is achieved.

As shown in fig. 1 and 6, the present application further provides an electrotome system for treating nodules in the airway, which comprises the electrotome for treating nodules in the airway in the above embodiments, an operating handle 4 connected to the proximal end of the tube 1, and a lead 5 threaded into the tube 1 for delivering radio frequency energy to the electrode 2.

The proximal end of the catheter is provided with a pipeline interface 6, the pipeline interface 6 is connected with a power device (not shown) for driving the medium in the catheter to flow, and the distal end of the electrode 2 is used as a fluid passing port. When the internal segment of the air flue is treated, negative pressure smoke exhaust can be formed in the external segment 212 through the power device.

As shown in fig. 6, in an embodiment, the operating handle 4 includes a first supporting shell 41 and a second supporting shell 42 which are mutually oblique and communicated, and the operating handle 4 can be in a radial split fastening mode in general.

The proximal end of the catheter (not shown in fig. 6) passes through the first support housing 41 and then communicates with the line connector 6, and the line connector 6 is connected to a power device (such as a vacuum pump) through a luer connector.

One end opening of the second supporting shell 42 is communicated with the first supporting shell 41, the banana junction 7 is installed in the second supporting shell 42, and the banana junction 7 extends out of the other end opening of the second supporting shell 42.

As shown in fig. 5, the conducting wire 5 may be an enameled wire, and in the extending direction of the conducting wire 5, the middle part of the conducting wire is embedded in the pipe wall of the pipe body 1, and the part of the conducting wire 5 is insulated from the electrode 2.

The distal portion of lead 5 is electrically connected to electrode 2 and may also be electrically connected to the inner section 211, such as to the proximal, distal or axially intermediate portion of inner section 211.

The lead 5 is connected to the electrode 2 or the inner segment 211 and is typically fixed by welding, and the lead 5 may be located on the outer peripheral surface of the electrode 2 or the inner segment 211, and in another embodiment, the lead 5 may extend radially from the outer side to the inner peripheral surface. The proximal end of the lead 5 passes through the tube body 1, enters the second supporting shell 42 through the first supporting shell 41, and is electrically connected with the banana joint 7, so as to be conveniently connected with an external circuit.

In one embodiment, as shown in FIG. 7, the distal end of the connecting tube 21 is provided with a sharpened portion 23, so that the sharpened portion 23 can reduce the resistance of the distal end of the electrode 2 to penetrate into the tissue, and facilitate obtaining a sample of the diseased tissue for detection. Specifically, the distal end of the sharp point part 23 is provided with a puncture inclined plane 24, and the included angle between the puncture inclined plane 24 and the axial direction of the tube body 1 is 20-60 degrees.

The tip cutting part 24 is arranged at the far end of the electrode 2, so that an operator can conveniently master the accurate information of the lesion tissue. In one aspect, prior to delivery of the electrical discharge ablation, the tissue can be removed through the sharpened portion 24 and the lesion in the tissue detected, providing guidance on the ablation treatment to be delivered, such as providing a reference for ablation time and power. On the other hand, the cutting tip 24 may be used to perform the electric discharge ablation on the lesion tissue, and after the ablation is finished, the cutting tip 24 is still used to take out the tissue sample from the original ablation site for the secondary detection, so as to determine whether the ablation is sufficient.

In particular, the sampling operation may be accomplished through the distal end of the tube 1. The detection step and the treatment step are combined through the sharpened portion 24, and tedious repeated positioning is omitted. The application provides an electrotome and electrotome system conveniently treats interior knot of air flue, and can reduce the electrode risk of droing.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The electrotome for treating the nodules in the airway comprises a tube body and electrodes which are connected with each other, wherein the tube body is provided with a far end and a near end which are opposite to each other; the electrode includes:

2. The electrotome according to claim 1, wherein the inner section is a helical band structure, and the hollow area is defined by the gap between adjacent turns of the helical band.

3. The electrotome for treating nodules in the airway as claimed in claim 1, wherein the length of the section with hollowed-out area in the built-in section is 5-8 cm.

4. The electrotome for treating nodules in the airway as claimed in claim 1, wherein the position of the smoke evacuation holes corresponds to the position of the hollowed out area of the inner section.

5. The electrotome according to claim 1, wherein the smoke evacuation holes are arranged in a plurality along the length of the tube.

6. The electrotome for treating nodules in the airway as claimed in claim 1, wherein said smoke evacuation holes are arranged in a manner matching the shape of said hollowed out area.

7. The electrotome for treating nodules in the airway as claimed in claim 1, wherein said discharge head is removably attached or welded to said connecting tube.

8. The electrotome according to claim 1 for treating nodules within the airway, wherein said discharge head comprises, in order from proximal to distal:

9. The electrotome according to claim 8, wherein a stop step is provided between the connecting section and the tapered section against the distal end face of the externally positioned section.

10. The electrotome for treating nodules in the airway as claimed in claim 9, wherein the connecting section is inserted into the external section, and the outer circumferential surface of the limiting step is flush with the outer circumferential surface of the external section.