WO2021063139A1

WO2021063139A1 - Multifunctional high-frequency electrotome

Info

Publication number: WO2021063139A1
Application number: PCT/CN2020/111856
Authority: WO
Inventors: 唐志; 范茗侨; 沙德青; 李常青; 奚杰峰; 金鸿雁; 李宁; 韦建宇; 刘春俊
Original assignee: 南微医学科技股份有限公司
Priority date: 2019-09-30
Filing date: 2020-08-27
Publication date: 2021-04-08
Also published as: CN110507412A

Abstract

Disclosed is a multifunctional high-frequency electrotome, comprising a cutting unit, an injection unit, an elastic member, and a handle component, wherein the cutting unit comprises an electrode part; the injection unit comprises an injection needle; the cutting unit is arranged inside the injection unit; the elastic member is elastically pressed onto the outer walls of the injection needle and the electrode part, and allows the injection needle to slide to and fro; and the handle component comprises a first handle at the proximal side and a second handle at the distal side, with the first handle being configured to control the sliding of the cutting unit, and the second handle being configured to control the sliding of the injection unit. The multifunctional high-frequency electrotome does not need to exchange instruments during a surgical operation so as to shorten the operation time, and can achieve an adjustable protruding length and accurate positioning of the electrode part so as to avoid the use of multiple different independent instruments during the surgical operation that would increase the patient's medical burden. In addition, the electrode part can be non-return, and high-flow injection is achieved in order to perform rapid liquid injection.

Description

Multifunctional high-frequency electric knife

Cross-references to related applications

This application claims the priority of a Chinese patent application filed with the China Patent Office on September 30, 2019 with the application number 201910937835. 2, titled "a multifunctional high-frequency electric knife", the entire content of which is incorporated into this application by reference .

Technical field

This application relates to a high-frequency electrosurgical knife, in particular to a multifunctional electrosurgical knife that integrates the functions of marking, injection, cutting, washing, scraping and exchange-free and can be accurately positioned.

Background technique

This application relates to a multifunctional high-frequency electrosurgical unit, in particular to an instrument that can realize low-cost passive injection and active high-frequency cutting, which can realize the exemption of instrument exchange during the operation to shorten the operation time, and can achieve high The protruding length of the frequency cutting electrode is adjusted by the handle and accurately positioned, which avoids the use of multiple different instruments during the operation to increase the medical burden of the patient. At the same time, the length of the needle can be adjusted according to different digestive tract tissues to make the liquid injection safer.

Endoscopic submucosal dissection (ESD) refers to a minimally invasive endoscopic technique for submucosal dissection of lesions larger than 2 cm using high-frequency equipment. ESD indications are mainly early gastrointestinal cancer or precancerous lesions with extremely low lymph node metastasis rate. The steps include: ① marking; ② submucosal injection; ③ circumferential incision; ④ mucosal peeling; ⑤ wound treatment; ⑥ specimen processing.

In the traditional technique, ① marking, ③ circumferential incision, ④ mucosal peeling are realized by high-frequency electrosurgical knife; ② submucosal injection is realized by injection needle; ⑤ wound treatment is realized by electrocoagulation forceps. In the process of mucosal dissection, submucosal injection can lift the lesion and separate the muscle layer, which is beneficial to complete the resection of the lesion without damaging the muscularis propria, reducing the occurrence of complications such as perforation and bleeding. Therefore, the high-frequency electrosurgical knife and injection needle need to be frequently replaced during the operation for submucosal rehydration. Frequent replacement of injection needles and high-frequency electrosurgical units greatly prolongs the operation time, increases the patient's anesthesia time, and increases the risk.

In order to improve this situation, there are a variety of high-frequency electrosurgical units for needle-free injection on the market, but submucosal injection is divided into injection during mucosal resection and injection during submucosal peeling. Needle-free injection of the high-frequency electrosurgical unit can achieve swelling of the loose submucosa connective tissue. However, due to the limitation of safety considerations, the high-frequency electrosurgical unit is limited in length and cannot enter the submucosa. The same injection volume makes the elevating effect inferior to injection Needle effect is good. For the injection during mucosal resection, compared with the loose submucosa, the mucosal layer cannot be pierced and injected without a needle under the conventional output pressure. ERBE’s fine water jet separation equipment can provide a stable high-pressure water jet. Although the Haibo knife can penetrate the mucosal layer to achieve submucosal injection without a needle tip, the price of its water jet separation equipment allows ordinary hospitals Discouraged. This undoubtedly brings a great burden to patients and hospitals.

In addition, the minimum inner diameter of the injection channel in the prior art is usually smaller than or equal to the inner diameter of the electrosurgical rod. Due to this limitation, the flow rate during injection is too small, or pressure is required to maintain a larger flow rate.

In summary, there is an urgent need to design a low-cost, replacement-free endoscopic treatment device that can extend through the same endoscopic channel and separate the needle and the knife.

In view of this, this application is hereby submitted.

Summary of the invention

Based on the technical problems of frequent instrument replacement and low injection flow in the prior art, the present application provides a multifunctional high-frequency electrosurgical knife, which includes: a cutting unit, an injection unit, an outer sheath, and a handle part; the cutting unit includes an electrode part The injection unit includes an injection needle; the cutting unit is built in the injection unit; the electrode part can slide proximally relative to the injection needle and completely withdraw from the injection needle.

Like the aforementioned multifunctional high-frequency electrosurgical unit, the injection unit includes an injection needle, an injection needle seat and a middle tube; the inner diameter of the middle tube is larger than the inner diameter of the injection needle; the proximal inner surface of the injection needle seat is tapered to the distal end , Configured to guide the electrode part into the inner cavity of the injection needle.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the injection needle is in fluid communication with the middle tube through the injection needle seat.

As the aforementioned multifunctional high-frequency electrosurgical unit, the proximal end of the injection needle holder and/or the distal end of the middle tube are provided with side holes or side grooves at the junction of the two, configured to connect the inner cavity of the injection needle and the middle tube and The gap cavity of the outer sheath is connected to form a liquid injection channel.

As in the aforementioned multifunctional high-frequency electric knife, the handle component includes a first handle and a second handle, the first handle is configured to control the sliding of the cutting unit, and the second handle is configured to control the sliding of the injection unit.

A multifunctional high-frequency electrosurgical knife is also provided, which includes: a cutting unit, an injection unit, an outer sheath, a handle part, and an elastic member; the cutting unit includes an electrode part; the injection unit includes an injection needle; the cutting unit is built in the injection unit; The elastic member is fixedly arranged in the inner cavity of the distal end of the outer sheath or on the outer tube wall, one end of the elastic member is fixed relative to the outer sheath, and the other end can be crimped on the outer wall of the injection needle and the electrode part to Form a good contact; when the elastic member is elastically crimped onto the electrode part, it realizes the non-return of the electrode part to prevent it from completely retracting into the outer sheath; preferably, the elastic member is elastically crimped onto the electrode part. When the electrode part is engaged with the groove or radial protrusion of the electrode part, the electrode part can be prevented from being completely retracted into the outer sheath.

The handle component includes a first handle and a second handle, the first handle is configured to control the sliding of the cutting unit, and the second handle is configured to control the sliding of the injection unit.

As in the aforementioned multifunctional high-frequency electrosurgical knife, the elastic member includes a first elastic piece and a second elastic piece; the second elastic piece is joined with the electrode part to prevent the electrode part from being retracted completely to prevent it from being completely retracted to the outer sheath Inside.

As the aforementioned multifunctional high-frequency electrosurgical unit, the elastic member includes a first elastic piece and a second elastic piece; the first elastic piece and the second elastic piece are both arranged on the proximal or distal side of the distal end surface of the outer sheath; One end is fixed to the tube wall of the outer sheath, the first elastic piece extends obliquely to the distal end, and the other end of the distal end close to the axis is a free end; the second elastic piece extends radially outward from the free end of the first elastic piece and hangs in the air; When the first elastic piece and the second elastic piece are both arranged on the proximal side of the distal surface of the outer sheath, the radial length of the second elastic piece is less than or equal to the difference between the radius of the outer sheath and the radius of the injection needle, and the elastic member is elastically deformed When the injection needle is allowed to pass through; when the first elastic piece and the second elastic piece are both arranged on the far side of the distal end surface of the outer sheath, the radial length of the second elastic piece is smaller than the radius of the outer sheath, preferably the radial direction of the second elastic piece The length is less than or equal to the difference between the radius of the outer sheath and the radius of the electrode part at the crimped position.

As the aforementioned multifunctional high-frequency electric knife, the elastic member includes a first elastic piece and a second elastic piece; the first elastic piece and the second elastic piece are respectively arranged on the far and near sides of the distal end surface of the outer sheath; One end is fixed to the inner cavity wall of the outer sheath, the first elastic piece extends obliquely to the distal end, and the other end close to the axis is the free end; the second elastic piece extends radially outward from the free end of the first elastic piece and hangs in the air , The radial length of the second elastic piece is less than the radius of the outer sheath, preferably less than or equal to the difference between the radius of the outer sheath and the radius of the electrode part at the crimped position, more preferably less than or equal to the radius of the outer sheath and the radius of the rod electrode It has a larger area for better electrocoagulation and marking.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the elastic member includes a first elastic piece and a second elastic piece; both the first elastic piece and the second elastic piece are arranged on the proximal and distal sides of the distal surface of the outer sheath or are respectively arranged on the outer sheath. The far and near sides of the distal surface of the sleeve; one end of the first elastic piece is fixed on the tube wall of the outer sheath, the first elastic piece extends obliquely to the distal end, and the other end of the distal end close to the axis is a free end; the second elastic piece starts from The free end of the first elastic piece extends axially to the distal end.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the elastic member also has a distal end surface of the elastic piece; the distal end surface of the elastic piece extends radially outward from the distal end of the second elastic piece and is suspended; the radial length of the distal end surface of the elastic piece is less than The radius of the outer sheath, preferably the radial length of the second elastic piece is less than or equal to the difference between the radius of the outer sheath and the radius of the electrode portion at the crimped position, more preferably less than or equal to the radius of the outer sheath and the radius of the rod electrode difference.

As the aforementioned multifunctional high-frequency electrosurgical unit, the elastic member includes a first elastic piece, a second elastic piece, a connecting portion of the elastic piece and a distal end surface of the elastic piece; the distal end surface of the elastic piece covers the distal end of the outer sheath; One end of an elastic piece is fixed to the inner cavity wall of the outer sheath, and one end of the second elastic piece is electrically connected and fixed on the periphery of the distal end surface of the elastic piece; the first elastic piece and the second elastic piece extend obliquely to the distal and proximal sides, respectively. The other end is connected by a radially arranged elastic piece connecting portion; the elastic piece connecting portion and the axial hole on the distal end surface of the elastic piece constitute a stepped portion, which is configured to realize the check of the radial protrusion to prevent it from retracting into the outer sheath.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the radial length of the connecting portion of the shrapnel is less than or equal to the difference between the radius of the outer sheath and the radius of the injection needle, and when the elastic member is elastically deformed, the injection needle is allowed to pass; The shaft hole allows the injection needle to pass through; the distal end surface of the shrapnel can be electrically connected with the radial protrusion to jointly perform electrocoagulation and marking functions.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the proximal end of the elastic member or the first elastic piece is also provided with an elastic piece tubular section; the elastic piece tubular section is adapted to the inner cavity or outer tube wall of the outer sheath, or is arranged in the outer sheath The tube wall of the sleeve is configured to firmly fix the elastic member to the outer sheath by a fixing method such as bonding, welding, or clamping.

As in the aforementioned multifunctional high-frequency electric knife, when the tubular section of the shrapnel is arranged on the outer tube wall of the outer sheath, it is made of insulating material or provided with an insulating coating.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the elastic member includes a first elastic piece, a second elastic piece, a distal end surface of the elastic piece and a tubular section of the elastic piece; both the first elastic piece and the second elastic piece are arranged in the inner cavity of the distal end of the outer sheath One end of the first elastic piece is fixed to the inner cavity wall of the outer sheath, the first elastic piece extends obliquely to the distal end, and the other end of the distal end close to the axis is the free end; the second elastic piece is radially from the free end of the first elastic piece Extend and suspend, the radial length of the second elastic piece is less than or equal to the difference between the radius of the outer sheath and the radius of the injection needle, and when the elastic member is elastically deformed, the injection needle is allowed to pass; the tubular section of the elastic piece and the inner cavity of the outer sheath The distal end of the shrapnel covers the distal end of the outer sheath, and is electrically connected to the first shrapnel through the tubular section of the shrapnel; the radial length of the distal end of the shrapnel is greater than or equal to the difference between the radius of the outer sheath and the radius of the injection needle, And its axial hole allows the injection needle to pass through; the distal surface of the shrapnel can perform electrocoagulation and marking functions together with the radial protrusion.

There is also provided a multifunctional high-frequency electrosurgical knife, including: a cutting unit, an injection unit, an electrocoagulation unit, and a handle part; the cutting unit includes an electrode part; the injection unit includes an injection needle; the cutting unit is built in the injection unit; and the electrocoagulation unit includes The metal electrocoagulation ring at the distal end and a conductive elastic member; the metal electrocoagulation ring is arranged in the inner cavity of the distal end of the outer sheath, and the inner cavity of the metal electrocoagulation ring allows the injection needle to slide through; the elastic member is elastically crimped in the injection The outer wall of the needle to form a good electrical connection and allow the injection needle to slide; the handle component includes a first handle and a second handle, the first handle is configured to control the sliding of the cutting unit, and the second handle is configured to control the The sliding of the injection unit.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the electrode part includes a rod-shaped electrode and a radial protrusion located at the distal end of the rod-shaped electrode; the electrode part is slidably arranged in the injection needle, and the radial protrusion is electrically connected to the inner wall of the injection needle.

As in the aforementioned multifunctional high-frequency electrosurgical unit, when the elastic member is elastically crimped onto the rod-shaped electrode, the engagement with the groove or the radial protrusion of the electrode part can stop the radial protrusion, so as to Prevent the electrode part from completely retracting into the outer sheath.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the rod-shaped electrode includes a conductive section at the distal end and an insulating outer coating section at the proximal end.

As in the aforementioned multifunctional high-frequency electrosurgical knife, the cutting unit further includes a conductive shaft and a connector; the proximal end of the electrode part and the distal end of the conductive shaft are fixed and electrically connected by the connector provided on the outside; and the radial protrusion The proximal end is provided with a guide member configured to guide the radial protrusion to retract into the injection needle after protruding the injection needle.

Like the aforementioned multifunctional high-frequency electrosurgical unit, the injection unit also includes an injection needle seat and a middle tube; the injection needle is made of rigid conductive material, has a distal tip, and is in fluid communication with the outer sheath or the middle tube through the injection needle seat The injection needle holder is arranged at the distal end of the middle tube, and the proximal inner surface of the injection needle holder is tapered to the distal end and is configured to guide the electrode part into the inner cavity of the injection needle.

As the aforementioned multifunctional high-frequency electrosurgical unit, the inner cavity of the metal electrocoagulation ring is provided with an insulating layer; the distal end surface of the metal electrocoagulation ring is flush with the distal end surface of the outer sheath, or the metal electrocoagulation ring has a protruding outer surface. The end of the distal face of the sheath.

As the aforementioned multifunctional high-frequency electrosurgical knife, the elastic member includes a first elastic piece, a second elastic piece, and a connecting portion configured to connect the first elastic piece and the second elastic piece; the first elastic piece is radially arranged and connected near the metal electrocoagulation ring End; the first elastic piece and the second elastic piece are arranged at an obtuse angle, the first elastic piece is closer to the distal end than the second elastic piece.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the diameter of the connecting portion is smaller than the outer diameter of the injection needle. When the elastic member is elastically pressed against the outer wall of the injection needle, the first elastic piece is inclined toward the proximal end, and the connecting portion It is electrically connected to the second elastic piece and crimped on the outer wall of the injection needle; when the injection needle is retracted proximally to the nearest end of the stroke, the connecting part is disconnected from the injection needle, and the first elastic piece returns to the radial orientation, so that the second The free end of the shrapnel can tightly press the rod-shaped electrode.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the elastic member includes a radially arranged limiting protrusion, a first elastic piece, a second elastic piece, and a connecting portion configured to connect the first elastic piece and the second elastic piece; the first elastic piece is radially arranged And connected to the proximal end of the metal electrocoagulation ring; the first elastic piece and the second elastic piece are arranged at an obtuse angle, and the second elastic piece is closer to the distal end than the first elastic piece.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the diameter of the connecting portion is smaller than the outer diameter of the injection needle. Therefore, when the elastic member is elastically pressed against the outer wall of the injection needle, the first elastic piece is inclined to the distal end, and the connection When the injection needle is retracted proximally to the nearest end of the stroke, the connecting part is disconnected from the injection needle, and the first elastic plate returns to the radial orientation, so that the second elastic plate The free end of the rod can be pressed tightly to the rod-shaped electrode; at this time, the rod-shaped electrode can slide far and near by pushing and pulling, so that the second elastic piece can act as a scraper and is configured to scrape off the condensate attached to the rod-shaped electrode to restore the rod-shaped electrode The cutting function; the limiting protrusion abuts on the proximal end of the first elastic piece to prevent the first elastic piece from being excessively deformed proximally during the sliding process of the rod electrode after the first elastic piece restores its radial orientation.

As in the aforementioned multifunctional high-frequency electrosurgical knife, there are multiple first elastic pieces and multiple second elastic pieces; the elastic member is formed by pressing ring-shaped elastic pieces, and the connecting part is formed by bending and pressing to form a groove structure with an arc-shaped cross section. The annular elastic piece is divided into an outer ring portion and an inner ring portion; wherein the outer ring portion is configured to form a first elastic piece, and the inner ring portion is configured to form the second elastic piece; by cutting a number of lines on the outer ring portion of the annular elastic piece Grooves to form a plurality of the first elastic pieces; by cutting a plurality of rectangular grooves, triangular grooves, trapezoidal grooves, fan-shaped grooves, or fan-ring grooves at positions corresponding to the wire grooves of the inner ring portion, a plurality of correspondingly formed One said second shrapnel.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the first handle is located at the proximal end of the second handle, and the two are arranged coaxially; the first handle includes a first core rod, a first positioning block and a first handle sliding part; The distal end of the core rod is fixedly connected to the proximal end of the second handle sliding part of the second handle; the proximal end of the first core rod is slidably arranged in the inner cavity of the first handle sliding part, and the two can slide relative to each other to drive the cutting The unit slides; the first positioning block is provided at the distal end of the sliding portion of the first handle, and the first positioning block is configured to lock or release the sliding connection between the first core rod and the sliding portion of the first handle.

As the aforementioned multifunctional high-frequency electrosurgical unit, the second handle includes a diameter-reducing handle portion, a second core rod, a second positioning block and a second handle sliding portion; the distal end of the diameter-reducing handle portion and the proximal end of the outer sheath Connected, the proximal lumen of the variable-diameter handle portion is fixed with a second core rod; the proximal end of the second core rod is slidably arranged in the lumen of the second handle sliding portion, and the two are in fluid communication and can slide relatively to drive the The injection unit slides, the second handle sliding part is provided with a luer connector; the second handle sliding part is provided with the second positioning block at the distal end, and the second positioning block is configured to lock or release the second core rod and Sliding connection of the sliding part of the second handle.

As the aforementioned multifunctional high-frequency electrosurgical knife, the first positioning block and the second positioning block are screw cap tubes that cooperate with the corresponding threaded parts on the first handle sliding part and the second handle sliding part, and the first handle slides The threaded parts on the sliding part of the second handle and the second handle are both provided with a plurality of axial grooves.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the first positioning block and the second positioning block are pipe fittings that are non-threaded with the corresponding first handle sliding part and the second handle sliding part.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the first positioning block and the second positioning block are pressable elastic elements, which cooperate with the positioning slots provided on the corresponding first and second core rods. Realize the adjustment of positioning position.

As the aforementioned multifunctional high-frequency electrosurgical unit, when the injection needle protrudes from the distal end of the electrocoagulation unit, and the electrode part retracts proximally relative to the injection needle, separates from the inner cavity of the injection needle, and retracts into the middle tube, it can be injected. liquid.

As in the aforementioned multifunctional high-frequency electrosurgical unit, the injection needle is provided with an extension in the lumen of the middle tube, and the extension is configured to retract proximally and extend distally at the electrode portion. During the entire stroke, the electrode part is always in the inner cavity of the injection needle, the proximal end of the extension part is provided with a bendable part, and the bendable part is configured to allow the injection needle to pass through the bend For the cavity or endoscope, the bendable portion is provided with a slit configured to allow liquid to enter the injection needle, such as a spiral slit. As the aforementioned multifunctional high-frequency electrosurgical unit, when the rod-shaped electrode protrudes from the distal end of the electrocoagulation unit, and the distal end of the insulating outer coating section at the proximal end also extends outside the distal end of the electrocoagulation unit, the electrocoagulation unit is de-energized , The rod-shaped electrode is energized to realize the electric cutting.

Based on the above technical solution, this application has the following advantages:

1. It integrates the functions of check, marking, injection, cutting, washing and scraping.

2. When liquid is injected, the cutting unit retracts and has the characteristics of large flow injection for quick liquid injection.

3. When retracting the injection unit to expose the cutting unit to the maximum extent, the condensate attached to the rod electrode can be scraped off.

Description of the drawings

Fig. 1A is an overall schematic diagram of the first embodiment of the multifunctional high-frequency electric knife.

Fig. 1B is an overall schematic diagram of the second embodiment of the multifunctional high-frequency electric knife.

2A-2B are schematic diagrams of electrode parts.

Figures 3A-3D are schematic diagrams of the injection unit.

4A-4H are schematic diagrams of different configurations of the elastic member when the electrode part is elastically crimped.

Fig. 5 is an overall schematic diagram of the third embodiment of the multifunctional high-frequency electric knife.

Fig. 6 is a schematic diagram of the first configuration of the electrocoagulation unit.

Fig. 7 is a schematic diagram of the second configuration of the electrocoagulation unit.

Figure 8 is a schematic diagram of the handle components.

Figure 9 is a schematic diagram of the distal end structure of the multifunctional high-frequency electrosurgical unit under "coagulation"/"marking".

Figure 10 is a schematic diagram of the distal structure of the multifunctional high-frequency electrosurgical unit during "injection/flushing".

Figure 11 is a schematic diagram of the distal end of the multifunctional high-frequency electrosurgical unit during "resection".

Figure 12 is a schematic diagram of the distal end of the multifunctional high-frequency electrosurgical unit during "scraping".

13A-13B are schematic diagrams of the structure of the elastic member in the second embodiment.

Fig. 14 is a schematic diagram of two configurations of the elastic member in the second embodiment.

Fig. 15 is a schematic diagram of markings of the first core rod and the second core rod.

Description of reference signs:

1-cutting unit, 11-electrode section, 111-rod electrode, 1111-conductive section, 1112-insulating outer coating section, 112-radial protrusion at the distal end, 12-conductive shaft, 13-connector, 2 -Injection unit, 21-injection needle, 22-injection needle seat, 221-side hole or side groove, 23-in tube, 231-single steel wire, 3-electrocoagulation unit, 31-metal electrocoagulation ring, 311-insulation layer , 32-conductive elastic member, 3211-first shrapnel, 3212-second shrapnel, 3213-shrapnel connecting part, 322- shrapnel distal surface, 323-shrapnel tubular section, 324-limiting ring, 4-outer guard Sleeve, 41-middle slender part, 42-distal enlarged part, 43-tapered transition part, 421-distal indented end face/distal face, 5-handle part, 51-first handle, 511-first Core rod, 512-first positioning block, 513-first handle sliding part, 5131-electrical connection terminal, 52-second handle, 521-reducing handle part, 522-second core rod, 523-second positioning Block, 524-the sliding part of the second handle

Detailed ways

The technical content of this application will be described in detail with reference to the drawings and specific embodiments.

The embodiments of the present application will be described in detail below in conjunction with examples, but those skilled in the art will understand that the following examples are only used to illustrate the present application, and should not be regarded as limiting the scope of the present application.

Some terms involved in this application are explained. The proximal end refers to the end close to the operator outside the body; the distal end refers to the end located in the target tissue to be treated in the body; the axial direction refers to the longitudinal direction extending along the central axis of the device body; the radial refers to the direction perpendicular to the axial direction; The circumferential direction refers to the circumferential direction around the axial direction; the radial length refers to the length in the radial direction perpendicular to the axial direction, that is, the length in the radial direction on one side of the central axis.

As shown in FIG. 1A, FIG. 1B and FIG. 5, the multifunctional high-frequency electric knife of the present application includes: a cutting unit 1, an injection unit 2, an outer sheath 4, a handle part 5 and an elastic member 32.

The cutting unit 1 includes an electrode part 11, a conductive shaft 12 and a connecting member 13. The cutting unit 1 is built in the injection unit 2.

As shown in FIGS. 3A to 3D, the injection unit 2 includes an injection needle 21, an injection needle seat 22 and a middle tube 23.

The electrode part 11 includes a rod-shaped electrode 111 and a distal radial protrusion 112; the electrode part 11 can be slidably arranged in the injection needle 21. The proximal end of the electrode portion 11 and the distal end of the conductive shaft 12 are fixed and electrically connected by the connecting member 13 provided on the outside.

As shown in FIG. 2A, the rod electrode 111 can be further divided into a conductive section 1111 at the distal end and an insulating outer coating section 1112 at the proximal end. The proximal end of the radial protrusion 112 has a guide member configured to guide the radial protrusion 112 to retract into the injection needle 21 after protruding the injection needle 21. The radial protrusion 112 is preferably spherical, or a protruding structure with a tapered structure that tapers toward the proximal end at the proximal end.

The conductive shaft 12 is a spiral part covered with an insulating coating, including a conductive spiral part and an insulating coating covering the surface of the spiral part. The material of the insulating coating is a polymer material or other insulating properties that can be used for the human body. material. The proximal end of the conductive shaft 12 is connected to the electrical connection terminal 5131, and the distal end of the conductive shaft 12 is connected to the proximal end of the electrode part 11 to supply power to the electrode part 11.

The conductive shaft 12 may also be a straight groove covered with an insulating coating.

As shown in FIG. 2B, the electrode part 11 also has another configuration, which is a hollow structure with an inner cavity. A connecting filament may also be arranged between the distal end of the conductive shaft 12 and the connecting member 13, so that the inner cavity of the electrode portion 11 and the inner cavity of the middle tube 23 are connected to form a part of the fluid infusion channel.

The injection needle 21 is made of a rigid conductive material and has a distal tip, as shown in FIGS. 3A to 3D, which is in fluid communication with the middle tube 23 through the injection needle seat 22. In addition, the outer wall of the injection needle 21 may also be provided with an insulating layer. The proximal end of the injection needle 21 is connected to the inner cavity of the injection needle hub 22. The injection needle holder 22 is sleeved in the distal lumen of the middle tube 23. The proximal inner surface of the injection needle holder 22 is tapered toward the distal end and is configured to guide the electrode portion 11 into the lumen of the injection needle 21.

In addition, alternatively, as shown in FIG. 1A, the proximal end of the injection needle holder 22 and/or the distal end of the middle tube 23 are provided with a side hole 221 or a side groove 221 at the connection between the two, configured to connect the injection needle 21 The inner cavity communicates with the gap cavity between the middle tube 23 and the outer sheath 4 to form a liquid injection channel.

As shown in FIG. 1A, the elastic member 32 is a structure made of conductive material that is symmetrical with respect to the longitudinal axis. It is fixedly arranged in the inner cavity of the distal end of the outer sheath 4 and can be elastically crimped on the injection needle 21. And the outer wall of the electrode part 11. The proximal peripheral edge of the elastic member 32 is fixed relative to the outer sheath 4, and the axial side of the elastic member 32 is inclined toward the distal end in the elastic pressing state. When the injection needle 21 is withdrawn and the electrode portion 11 protrudes out of the injection needle 21, the elastic member 32 can be elastically crimped onto the rod-shaped electrode 111, and snap-fitted with the proximal end of the radial protrusion 112 to achieve radial alignment. The protrusion 112 is stopped to prevent it from retracting into the outer sheath 4. The elastic member 32 can also be snap-fitted with the guide member at the proximal end of the radial protrusion 112 to achieve a non-return. As a result, the guide member can not only be engaged with the elastic member 32 to achieve a non-return, but also can guide the radial protrusion 112 to retract into the injection needle 21 after protruding the injection needle 21. In addition, the elastic member 32 can also function as a scraper, configured to scrape off the condensate attached to the rod-shaped electrode 111, so as to restore the cutting function of the rod-shaped electrode 111.

The elastic member 32 has a variety of configurations. All or part of the elastic member 32 is located on the proximal or distal side of the distal retracted end face/distal face 421 of the outer sheath 4, that is, the outer sheath 4 The distal end in or outside the lumen. 4A-4F show various configurations of the elastic member 32 in a state where the elastic member 32 is elastically crimped on the electrode part, and it is emphasized that all or part of it is located at the distal end of the outer sheath 4 with the retracted end face/distal face 421 The proximal side is described as an example.

As shown in FIG. 1B, the middle tube 23 that drives the injection needle 21 is replaced with a single steel wire 231 to drive the injection needle 21. The single steel wire 231 is driven by the handle member 5 to obtain a larger injection channel space and thus a larger Liquid flow.

In the configuration shown in FIG. 4A, the elastic member 32 includes a first elastic piece 3211. The first elastic piece 3211 is arranged on the proximal or distal side of the distal retracted end face/distal face 421 of the outer sheath 4, and its proximal peripheral edge is fixed on the inner cavity wall (as shown in the upper figure of FIG. 4A) or the outer wall of the outer sheath 4 (Figure 4A, the bottom figure), or set in the tube wall of the outer sheath 4. The first elastic piece 3211 extends obliquely to the distal end, and the distal axis side thereof is a free end. When the elastic member 32 is elastically deformed, the first elastic piece 3211 allows the injection needle 21 to pass through. When abutting against the radial protrusion 112, the first elastic piece 3211 is configured to prevent the radial protrusion 112 from retracting into the outer sheath 4.

In the configuration shown in FIG. 4B, the elastic member 32 includes a first elastic piece 3211 and a second elastic piece 3212. The first elastic piece 3211 and the second elastic piece 3212 are arranged at an acute angle in the longitudinal section, and both are arranged on the proximal side of the distal retracted end surface/distal surface 421 of the outer sheath 4. The proximal peripheral edge of the first elastic piece 3211 is fixed to the inner cavity wall of the outer sheath 4, which extends obliquely to the distal end, and the axial side is a free end; the second elastic piece 3212 extends radially from the free end of the first elastic piece 3211 Extending outside, the peripheral edge of the second elastic piece 3212 is suspended. The radial length of the second elastic piece 3212 on the central axis side is less than or equal to the difference between the radius of the outer sheath 4 and the radius of the injection needle 21, and when the elastic member 32 is elastically deformed, the hole formed by the second elastic piece 3212 allows the injection needle 21 by. The second elastic piece 3212 and the axial hole of the distal retracted end surface/distal surface 421 constitute a stepped portion, which is configured to prevent the radial protrusion 112 from retracting into the outer sheath 4.

In another configuration as shown in FIG. 4C, the first elastic piece 3211 and the second elastic piece 3212 are respectively disposed on the far and near sides of the retracted end face/distal face 421 of the distal end of the outer sheath 4. The radial length of the second elastic piece 3212 is also greater, and it is set to be smaller than the radius of the outer sheath 4, preferably less than or equal to the difference between the radius of the outer sheath 4 and the radius of the rod electrode 111, so as to have a larger area for more Perform electrocoagulation and marking well.

In the configuration shown in FIG. 4D, the elastic member 32 includes a first elastic piece 3211 and a second elastic piece 3212. Both the first elastic piece 3211 and the second elastic piece 3212 are arranged on the proximal side of the distal end retracted/distal surface 421 of the outer sheath 4. The proximal peripheral edge of the first elastic piece 3211 is fixed to the inner cavity wall of the outer sheath 4, which extends obliquely to the distal end, and the axial side is a free end; the second elastic piece 3212 extends from the free end of the first elastic piece 3211 in the axial direction. Extend distally. When elastically deformed, the elastic member 32 allows the injection needle 21 to pass through. When abutting against the radial protrusion 112, the second elastic piece 3212 is configured to prevent the radial protrusion 112 from retracting into the outer sheath 4.

In addition, in another configuration as shown in FIG. 4E, the proximal end of the first elastic piece 3211 is also provided with an elastic piece tubular section 323. The elastic piece tubular section 323 is adapted to the inner cavity of the outer sheath 4 and is configured to firmly fix the elastic member 32 to the outer sheath 4 by a fixing method such as bonding, welding, or clamping.

In addition, in another configuration as shown in FIG. 4F, the elastic member 32 further has a distal end surface 322 of an elastic piece. The distal end surface 322 of the elastic piece extends radially outward from the distal end of the second elastic piece 3212, and the peripheral edge thereof is suspended. When abutting against the radial protrusion 112, the distal end surface 322 of the elastic piece is configured to prevent the radial protrusion 112 from retracting into the outer sheath 4. The radial length of the distal end surface 322 of the shrapnel is smaller than the radius of the outer sheath 4, preferably less than or equal to the difference between the radius of the outer sheath 4 and the radius of the rod-shaped electrode 111, so as to have a greater electrical connection with the radial protrusion 112 Area to better implement electrocoagulation and marking.

As shown in FIG. 4G, the elastic member 32 has another different configuration. The elastic member 32 includes a first elastic piece 3211, a second elastic piece 3212, an elastic piece connecting portion 3213 and a distal end surface 322 of the elastic piece. The difference from the first and second configurations is that the outer sheath 4 in this technical solution does not have a distal retracted end surface/distal surface 421, but instead is replaced by an elastic piece of the elastic member 32 The distal end surface 322 covers the distal end of the outer sheath 4. The axial sides of the first elastic piece 3211 and the second elastic piece 3212 extend obliquely to the distal side and the proximal side, respectively, and they are connected by a radially arranged elastic piece connecting portion 3213. The elastic piece connecting portion 3213 can also be arranged obliquely so that its peripheral edge is inclined to the proximal side, that is, the angle α formed by the first elastic piece 3211 and the elastic piece connecting portion 3213 is a larger angle than that of the elastic piece connecting portion 3213 shown in FIG. 4G when the elastic piece connecting portion 3213 is arranged radially. Smaller acute angle. The peripheral edge of the proximal end of the first elastic piece 3211 is fixed to the inner cavity wall of the outer sheath 4, and the peripheral edge of the second elastic piece 3212 is electrically connected and fixed to the peripheral edge of the distal surface 322 of the elastic piece. The radial length of the elastic piece connecting portion 3213 is smaller than the difference between the radius of the outer sheath 4 and the radius of the injection needle 21, and when the elastic member 32 is elastically deformed, the hole formed by the elastic piece connecting portion 3213 allows the injection needle 21 to pass through. In addition, the elastic piece connecting portion 3213 and the axial hole of the distal end surface 322 of the elastic piece constitute a stepped portion, which is configured to prevent the radial protrusion 112 from retracting into the outer sheath 4. The distal end surface 322 of the shrapnel covers the distal end of the outer sheath 4, and the radial length of the distal end surface 322 of the shrapnel is greater than or equal to the difference between the radius of the outer sheath 4 and the radius of the injection needle 21, and its axial hole allows the injection needle 21 to pass through . The distal end surface 322 of the shrapnel can perform electrocoagulation and marking functions together with the radial protrusion 112.

As shown in FIG. 4H, the elastic member 32 has another different configuration. The elastic member 32 includes a first elastic piece 3211, a second elastic piece 3212, a distal end surface 322 of the elastic piece, and a tubular section 323 of the elastic piece. The first elastic piece 3211 and the second elastic piece 3212 are arranged at an acute angle in the longitudinal section, and both are arranged in the inner cavity of the distal end of the outer sheath 4. The proximal peripheral edge of the first elastic piece 3211 is fixed on the inner cavity wall of the outer sheath 4, the first elastic piece 3211 extends obliquely to the distal end, and the distal axis side is a free end; the second elastic piece 3212 is separated from the first elastic piece 3211 The free end extends radially outward, the peripheral edge of the second elastic piece 3212 is suspended, the radial length of the second elastic piece 3212 is less than or equal to the difference between the radius of the outer sheath 4 and the radius of the injection needle 21, and the elastic member 32 is elastically deformed At this time, the hole formed by the second elastic piece 3212 allows the injection needle 21 to pass through. The elastic piece tubular section 323 is adapted to the inner cavity of the outer sheath 4; the distal end surface 322 of the elastic piece covers the distal end of the outer sheath 4, and is electrically connected to the first elastic piece 3211 through the elastic piece tubular section 323. The radial length of the distal end surface 322 of the elastic piece is greater than or equal to the difference between the radius of the outer sheath 4 and the radius of the injection needle 21, and its axial hole allows the injection needle 21 to pass through. The distal end surface 322 of the shrapnel can perform electrocoagulation and marking functions together with the radial protrusion 112.

The first elastic piece 3211 has a hole formed at the axis of the multifunctional high-frequency electrosurgical unit in a natural state that is smaller than the outer diameter of the rod-shaped electrode 111. When the first elastic piece 3211 is elastically crimped to the outer wall of the rod-shaped electrode 111 and/or the injection needle 21, the two are electrically connected. When the first elastic piece 3211 is elastically crimped to the outer wall of the rod-shaped electrode 111, it can also act as a scraper. It is configured to scrape off the condensate attached to the rod-shaped electrode 111 to restore the cutting function of the rod-shaped electrode 111.

The outer sheath 4 has a configuration in which the inner diameter and the outer diameter are the same as a whole, and may also have a configuration with different inner diameters and outer diameters. As shown in FIG. 1A, the outer sheath 4 has a middle elongated portion 41, a distal enlarged portion 42 and a tapered transition portion 43 connected between the two, wherein the inner diameter of the distal enlarged portion 42 is larger than the middle elongated portion 41 The inner diameter of the distal enlarged portion 42 is configured to accommodate the injection needle 21 and the injection needle hub 22. The distal end of the injection needle hub 22 is slidably fitted to the inner cavity of the distal enlarged portion 42, and is configured in cooperation with the tapered transition portion 43 In order to limit the retraction of the injection needle 21. The proximal end portion of the injection needle hub 22 is slidingly fitted with the inner cavity of the middle elongated portion 41.

In addition, in order to securely fix the elastic member 32 to the outer sheath 4, the embodiment shown in FIGS. 4A to 4G and similar configurations are arranged on the distal side of the distal end face/distal face 421. In the embodiment, the proximal end of the first elastic piece 3211 may be further provided with an elastic piece tubular section 323. The elastic piece tubular section 323 fits with the inner cavity or the outer tube wall of the outer sheath 4, or is arranged in the tube wall of the outer sheath 4, and is configured to fix the elastic member 32 by bonding, welding, or clamping. Securely fixed to the outer sheath 4. In addition, when the shrapnel tubular section 323 is arranged on the outer tube wall of the outer sheath 4, it is made of an insulating material or provided with an insulating coating.

As shown in Figure 8, the handle component 5 includes a proximal first handle 51 and a distal second handle 52. The first handle 51 is configured to control the sliding of the cutting unit 1, and the second handle 52 is configured to control The injection unit 2 slides. The first handle 51 is located at the proximal end of the second handle 52, and the two are arranged coaxially.

The first handle 51 includes a first core rod 511, a first positioning block 512 and a first handle sliding portion 513. The distal end of the first core rod 511 is fixedly connected to the proximal end of the second handle sliding portion 524 of the second handle 52. The proximal end of the first core rod 511 is slidably arranged in the inner cavity of the first handle sliding portion 513, and the two can slide relative to each other to drive the cutting unit 1 to slide. The first positioning block 512 is provided at the distal end of the first handle sliding portion 513, and the first positioning block 512 is configured to lock or release the sliding connection between the first core rod 511 and the first handle sliding portion 513.

As shown in FIG. 15, the first core rod 511 is provided with a scale and three functional positions are marked. The three functional positions are electrocutting, electrocoagulation, and injection/washing from far and near, and the reciprocating arrows mark "scrape" between the "resurgery" and "electrocoagulation" positions to show the two Sliding between the rod electrodes 111 can scrape off the condensate attached to the rod-shaped electrode 111.

The inner cavity of the proximal end of the first handle sliding portion 513 is provided with an electrical connection terminal 5131, which is configured to be connected to the high-frequency generator through a connecting cable, and the electrical connection terminal 5131 is electrically connected to the conductive shaft 12.

The second handle 52 includes a reducing handle portion 521, a second core rod 522, a second positioning block 523 and a second handle sliding portion 524. The distal end of the diameter-reducing handle portion 521 is connected to the proximal end of the outer sheath 4, and the inner cavity of the proximal end of the diameter-reducing handle portion 521 is fixed with a second core rod 522. The proximal end of the second core rod 522 is slidably arranged in the inner cavity of the second handle sliding portion 524, and the two are in fluid communication and can slide relatively to drive the injection unit 2 to slide. The second handle sliding portion 524 is provided with a luer connector. The second positioning block 523 is provided at the distal end of the second handle sliding portion 524, and the second positioning block 523 is configured to lock or release the sliding connection between the second core rod 522 and the second handle sliding portion 524.

The second core rod 522 is provided with a scale and three functional positions are marked. The three functional positions from far to near are injection/washing, electrocoagulation/cutting and scraping.

The first positioning block 512 and the second positioning block 523 are screw cap tubes that cooperate with the threaded parts on the corresponding first handle sliding part 513 and the second handle sliding part 524, the first handle sliding part 513 and the second handle The threaded parts on the sliding part 524 are all provided with a number of axial grooves.

The first positioning block 512 and the second positioning block 523 may also be pressable elastic elements, which can achieve positioning position by cooperating with positioning slots provided on the corresponding first core rod 511 and second core rod 522 Adjustment.

For the use of the configuration shown in Figures 4A-4H above, the process is as follows:

"Coagulation"/"Marking"

Set the first handle sliding portion 513 at the "electrocoagulation" position, and set the second handle sliding portion 524 at the "electrocoagulation/electrocutting" position, and pass the corresponding first positioning block 512 and second positioning block 523 Positioning. At this time, the injection needle 21 is inside the outer sheath 4, and the distal tip does not protrude from the distal end of the outer sheath 4; electrocoagulation/marking is performed through the radial protrusion 112, or the elastic member 32 and the radial protrusion 112 is electrically connected, thereby energizing the second elastic piece 3212/the distal end surface 322 of the elastic piece, and performing electrocoagulation/marking.

"Injection/Flushing"

The first handle sliding part 513 and the second handle sliding part 524 are both set at the "injection/flushing" position to push the injection needle 21 out, the rod-shaped electrode 111 retracts, and passes through the corresponding first positioning block 512 and second positioning block 512. The positioning block 523 performs positioning. At this time, the injection needle 21 protrudes from the distal end of the outer sheath 4, and the electrode portion 11 retracts proximally relative to the injection needle 21, detaches from the inner cavity of the injection needle 21, and retracts to the inner/side hole 221 or side of the middle tube 23 At the groove 221, a large flow of liquid can be injected, thereby speeding up the "uplifting" process.

"Electrical Cutting"

Set the first handle sliding part 513 at the "electrocutting" position, and set the second handle sliding part 524 at the "electrocoagulation/cutting" position to push out the rod electrode 111, and the injection needle 21 retracts and passes the corresponding The first positioning block 512 and the second positioning block 523 perform positioning. At this time, the rod-shaped electrode 111 protrudes at the distal end of the outer sheath 4, and the conductive section 1111 at the distal end completely protrudes, and the distal end of the insulating outer coating section 1112 at the proximal end also protrudes out of the distal end of the outer sheath 4. The elastic member 32 is elastically crimped on the insulating outer coating section 1112, so that the elastic member 32 is cut off, and only the rod-shaped electrode 111 is energized, so as to perform the electric cutting operation safely.

"Scrape"

Set the second handle sliding part 524 at the “coagulation/cutting” position; or set the second handle sliding part 524 at the “scrape” position to retract the injection needle 21 to the nearest end of the stroke, thereby turning the rod-shaped The electrode 111 is exposed outside the injection needle 21 to the greatest extent, and is positioned by the second positioning block 523.

At this time, the elastic member 32 is disconnected from the injection needle 21, so that the free end of the first elastic piece 3211 can tightly press the rod-shaped electrode 111. Push and pull the first handle sliding part 513 back and forth between the "electric cutting" and "electrocoagulation" positions to scrape off the condensate attached to the rod electrode 111 and restore the cutting function of the rod electrode 111.

In another embodiment, as shown in FIG. 5, the multifunctional high-frequency electrosurgical unit further includes a metal electrocoagulation ring 31 arranged in the inner cavity of the distal end of the outer sheath 4; the metal electrocoagulation ring 31 is located in a conductive The distal end of the elastic member 32 is electrically connected.

As shown in FIG. 6, the electrocoagulation unit 3 includes the metal electrocoagulation ring 31 and a conductive elastic member 32 at the distal end. The metal electrocoagulation ring 31 is arranged in the inner cavity of the distal end of the outer sheath 4, and the inner cavity of the metal electrocoagulation ring 31 allows the injection needle 21 to slide through, and is provided with an insulating layer 311. The distal end surface of the metal electrocoagulation ring 31 is flush with the distal end surface of the outer sheath 4, or the metal electrocoagulation ring 31 has an end protruding from the distal end surface of the outer sheath 4, forming an end cap structure.

The elastic member 32 is elastically pressed against the outer wall of the injection needle 21 to electrically connect the two and allow the injection needle 21 to slide far and near. The electrode part 11 is slidably disposed in the injection needle 21, and the radial protrusion 112 is electrically connected to the inner wall of the injection needle 21.

The elastic member 32 includes a first elastic piece 3211, a second elastic piece 3212, and an elastic piece connecting portion 3213 configured to connect the first elastic piece 3211 and the second elastic piece 3212. The first elastic piece 3211 is radially arranged and connected to the proximal end of the metal electrocoagulation ring 31. The first elastic piece 3211 and the second elastic piece 3212 are arranged at an obtuse angle in the longitudinal section, and the first elastic piece 3211 is closer to the distal end than the second elastic piece 3212.

The diameter of the elastic piece connecting portion 3213 is smaller than the outer diameter of the injection needle 21, so when the elastic member 32 is elastically pressed against the outer wall of the injection needle 21, the first elastic piece 3211 is inclined to the distal or proximal end, and the elastic piece is connected The portion 3213 is electrically connected to the second elastic piece 3212 and crimped on the outer wall of the injection needle 21. When the injection needle 21 is retracted proximally to the nearest end of the stroke, the elastic piece connecting portion 3213 is disconnected from the injection needle 21, and the first elastic piece 3211 returns to the radial orientation, as shown in FIG. 14, so that the second elastic piece 3212 is free The end can tightly press the rod-shaped electrode 111. At this time, the rod-shaped electrode 111 is slidingly moved far and near by pushing and pulling, so that the second elastic piece 3212 can function as a scraper and is configured to scrape off the condensate attached to the rod-shaped electrode 111 to restore the cutting function of the rod-shaped electrode 111.

As shown in FIGS. 13A-13B, the first elastic piece 3211 and the second elastic piece 3212 are both multiple, and both of them are in a ring shape as a whole. The elastic member 32 is formed by pressing an annular elastic piece. The elastic piece connecting portion 3213 is formed by bending and pressing to form a groove structure with an arc-shaped longitudinal section. The elastic piece connecting portion 3213 divides the annular elastic piece into an outer ring portion and an inner ring portion; The outer ring portion is configured to form the first elastic piece 3211, and the inner ring portion is configured to form the second elastic piece 3212. A plurality of the first elastic pieces 3211 are formed by cutting a number of wire grooves on the outer ring portion of the ring elastic piece; by cutting a number of rectangular grooves, triangular grooves, and trapezoids at positions corresponding to the wire grooves of the inner ring portion A groove, a fan-shaped groove or a fan-shaped annular groove correspondingly form a plurality of the second elastic pieces 3212.

In addition, the electrocoagulation unit 3 can also be configured as shown in FIG. 7. The elastic member 32 includes a radially-arranged limit ring 324, a first elastic piece 3211, a second elastic piece 3212, and an elastic piece connecting portion 3213 configured to connect the first elastic piece 3211 and the second elastic piece 3212. The first elastic piece 3211 is radially arranged and connected to the proximal end of the metal electrocoagulation ring 31. The first elastic piece 3211 and the second elastic piece 3212 are arranged at an obtuse angle in the longitudinal section, and the second elastic piece 3212 is closer to the distal end than the first elastic piece 3211.

The diameter of the elastic piece connecting portion 3213 is smaller than the outer diameter of the injection needle 21. Therefore, when the elastic member 32 is elastically pressed against the outer wall of the injection needle 21, the first elastic piece 3211 is inclined to the distal end, and the elastic piece connecting portion 3213 and The second elastic piece 3212 is electrically connected and crimped to the injection needle. When the injection needle 21 is retracted proximally to the nearest end of the stroke, the elastic piece connecting portion 3213 is disconnected from the injection needle 21, and the first elastic piece 3211 returns to the radial orientation, so that the free end of the second elastic piece 3212 can be tightly compressed Rod-shaped electrode 111. At this time, pushing and pulling the rod-shaped electrode 111 to realize the far and near sliding, so that the second elastic piece 3212 can function as a scraper, and is configured to scrape the condensate attached to the rod-shaped electrode 111 to restore the cutting function of the rod-shaped electrode 111. The limiting ring 324 abuts against the proximal end of the first elastic piece 3211 to prevent the first elastic piece 3211 from being excessively deformed proximally during the sliding process of the rod electrode 111 after the first elastic piece 3211 returns to the radial orientation.

The use process is as follows:

"Coagulation"/"Marking"

As shown in Figure 9, the first handle sliding portion 513 is set at the "electrocoagulation" position, and the second handle sliding portion 524 is set at the "electrocoagulation/electrocutting" position, and passes through the corresponding first positioning block 512 and The second positioning block 523 performs positioning. At this time, the injection needle 21 is in the outer sheath 4, the distal tip does not protrude from the distal end of the electrocoagulation unit 3, and the elastic connecting portion 3213 is electrically connected to the injection needle 21 and the radial protrusion 112, thereby being the main part of the electrocoagulation unit 3. The metal electrocoagulation ring 31 is energized to realize electrocoagulation/marking.

"Injection/Flushing"

As shown in Figure 10, both the first handle sliding portion 513 and the second handle sliding portion 524 are set at the "injection/flushing" position to push the injection needle 21 out, the rod electrode 111 retracts, and passes the corresponding first positioning The clamping block 512 and the second positioning block 523 perform positioning. At this time, the injection needle 21 protrudes at the distal end of the electrocoagulation unit 3, and the electrode part 11 retracts proximally relative to the injection needle 21, separates from the inner cavity of the injection needle 21, and retracts into the middle tube 23, thereby achieving a large flow rate Inject liquid to speed up the "uplifting" process.

"Electrical Cutting"

As shown in FIG. 11, the first handle sliding portion 513 is set at the "electrocutting" position, and the second handle sliding portion 524 is set at the "electrocoagulation/cutting" position to push out the rod electrode 111, and the injection needle 21 returns It is retracted and positioned by the corresponding first positioning block 512 and second positioning block 523. At this time, the rod-shaped electrode 111 protrudes at the distal end of the electrocoagulation unit 3, and the conductive section 1111 at the distal end completely protrudes, and the distal end of the insulating outer coating section 1112 at the proximal end also protrudes out of the distal end of the electrocoagulation unit 3, thereby achieving Power off the electrocoagulation unit 3. The rod-shaped electrode 111 is energized to realize electric cutting.

"Scrape"

As shown in FIG. 12, the second handle sliding portion 524 is set at the "scrape" position to retract the injection needle 21 to the nearest end of the stroke, thereby exposing the rod electrode 111 to the maximum extent of the injection needle 21, and The positioning is performed by the second positioning block 523. At this time, the elastic piece connecting portion 3213 is disconnected from the injection needle 21, and the first elastic piece 3211 returns to the radial orientation, so that the free end of the second elastic piece 3212 can tightly press the rod-shaped electrode 111. Push and pull the first handle sliding part 513 back and forth between the "electric cutting" and "electrocoagulation" positions to scrape off the condensate attached to the rod electrode 111 and restore the cutting function of the rod electrode 111.

With the above structure, marking, injection, cutting, washing and scraping can be realized, and precise positioning can be achieved. When liquid is injected, the cutting unit retracts and has the characteristics of large injection flow rate for quick liquid injection. When retracting the injection unit and exposing the cutting unit to the maximum extent, the condensate attached to the rod electrode can be scraped off. During the operation, replacement is avoided to shorten the operation time and to avoid the use of multiple different instruments during the operation to increase the medical burden of the patient.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the application, not to limit it; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand: It is still possible to modify the technical solutions recorded in the foregoing embodiments, or equivalently replace some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the embodiments of the present application Range.

Claims

A multifunctional high-frequency electric knife, comprising: a cutting unit (1), an injection unit (2), an outer sheath (4), a handle part (5) and an elastic member (32);

The cutting unit (1) includes an electrode part (11);

The injection unit (2) includes an injection needle (21);

The cutting unit (1) is built in the injection unit (2);

Its characteristics are:

The elastic member (32) is fixedly arranged at the distal end of the outer sheath (4), one end of the elastic member (32) is fixed relative to the outer sheath (4), and the other end can be crimped on the outer sheath (4). On the outer wall of the injection needle (21) or the electrode part (11); the elastic member (32) is elastically engaged with the electrode part (11), which can prevent the electrode part (11) from being completely retracted to the Inside the outer sheath (4);

The handle component (5) includes a first handle (51) and a second handle (52), the first handle (51) is configured to control the sliding of the cutting unit (1), and the second handle (52) ) Is configured to control the sliding of the injection unit (2).
The multifunctional high-frequency electric knife according to claim 1, wherein the elastic member (32) comprises a first elastic piece (3211) and a second elastic piece (3212); one end of the first elastic piece (3211) Fixed on the tube wall of the outer sheath (4), the first elastic piece (3211) extends obliquely to the distal end, and the other end of its distal side close to the axis is a free end; the second elastic piece (3212) extends from the The free end of the first elastic piece (3211) extends radially outward and is suspended; wherein,

The first elastic piece (3211) and the second elastic piece (3212) are both arranged on the proximal side of the distal end retracted end surface (421) of the outer sheath (4); the second elastic piece (3212) The radial length of) is less than or equal to the difference between the radius of the outer sheath (4) and the radius of the injection needle (21);

or,

The first elastic piece (3211) and the second elastic piece (3212) are respectively arranged on the far and near sides of the distal end retracted end surface (421) of the outer sheath (4); the second elastic piece ( 3212) has a radial length smaller than the radius of the outer sheath (4);

or,

The first elastic piece (3211) and the second elastic piece (3212) are both arranged on the far side of the distal end surface of the outer sheath (4); the radial length of the second elastic piece (3212) It is smaller than the radius of the outer sheath (4).
The multifunctional high-frequency electric knife according to claim 1, wherein the elastic member (32) comprises a first elastic piece (3211) and a second elastic piece (3212); one end of the first elastic piece (3211) Fixed on the tube wall of the outer sheath (4), the first elastic piece (3211) extends obliquely to the distal end, and the other end of its distal side close to the axis is a free end; the second elastic piece (3212) extends from the The free end of the first elastic piece (3211) extends axially to the distal end; wherein,

The first elastic piece (3211) and the second elastic piece (3212) are both arranged on the proximal side of the distal surface of the outer sheath (4);

or,

The first elastic piece (3211) and the second elastic piece (3212) are respectively arranged on the far and near sides of the distal end surface of the outer sheath (4);

or,

The first elastic piece (3211) and the second elastic piece (3212) are both arranged on the far side of the distal end surface of the outer sheath (4).
The multifunctional high-frequency electrosurgical unit according to claim 3, characterized in that: the elastic member (32) further has a distal end surface (322) of an elastic sheet; the distal end surface (322) of the elastic sheet is formed by the second elastic sheet The distal end of the (3212) extends radially outward and is suspended; the radial length of the distal end surface (322) of the shrapnel is smaller than the radius of the outer sheath (4).
The multifunctional high-frequency electrosurgical unit according to claim 1, wherein the elastic member (32) comprises a first elastic piece (3211), a second elastic piece (3212), an elastic piece connecting portion (3213) and a distal end of the elastic piece Surface (322); the distal end surface (322) of the elastic piece covers the distal end of the outer sheath (4); one end of the first elastic piece (3211) is fixed inside the outer sheath (4) In the cavity wall, one end of the second elastic piece (3212) is electrically connected and fixed to the peripheral edge of the distal end surface (322) of the elastic piece; the first elastic piece (3211) and the second elastic piece (3212) are respectively far away The side and the proximal side extend obliquely, and the other ends of the two are connected by the shrapnel connecting portion (3213) arranged radially; the shrapnel connecting portion (3213) is formed by the axial hole of the distal surface (322) of the shrapnel The step part is configured to realize the non-return of the electrode part (11) to prevent it from being completely retracted into the outer sheath (4).
The multifunctional high-frequency electrosurgical unit according to claim 5, characterized in that: the radial length of the elastic piece connecting portion (3213) is less than or equal to the radius of the outer sheath (4) and the injection needle (21) The difference in the radius; the axial hole of the distal surface of the shrapnel (322) allows the injection needle (21) to pass; the distal surface of the shrapnel (322) can be electrically connected with the electrode part (11) to be common Implement electrocoagulation and marking functions.
The multifunctional high-frequency electrosurgical unit according to any one of claims 1-6, characterized in that: the proximal end of the elastic member (32) or the first elastic piece (3211) is further provided with an elastic piece tubular section (323); The elastic piece tubular section (323) fits with the inner cavity or outer tube wall of the outer sheath (4), or is arranged in the tube wall of the outer sheath (4), and is configured to make the elastic The component (32) is firmly fixed to the outer sheath (4).
The multifunctional high-frequency electrosurgical unit according to claim 1, wherein the elastic member (32) comprises a first elastic piece (3211), a second elastic piece (3212), a distal end surface (322) of the elastic piece and a tubular elastic piece Section (323); the first elastic piece (3211) and the second elastic piece (3212) are both arranged in the distal end cavity of the outer sheath (4); one end of the first elastic piece (3211) Fixed on the inner cavity wall of the outer sheath (4), the first elastic piece (3211) extends obliquely to the distal end, and the other end of the first elastic piece (3211) close to the axis is a free end; the second elastic piece (3212) extends from The free end of the first elastic piece (3211) extends radially outward and is suspended, and the radial length of the second elastic piece (3212) is less than or equal to the radius of the outer sheath (4) and the injection needle ( 21) the difference in radius; the tubular section of the shrapnel (323) fits the inner cavity of the outer sheath (4); the distal end surface (322) of the shrapnel covers the outer sheath (4) The distal end is electrically connected to the first elastic piece (3211) through the elastic piece tubular section (323); the radial length of the distal end surface (322) of the elastic piece is greater than or equal to the radius of the outer sheath (4) and The difference in the radius of the injection needle (21), and the axial hole of the injection needle allows the injection needle to pass through; the distal end surface (322) of the elastic sheet and the electrode part (11) can perform electrocoagulation and marking functions together.
A multifunctional high-frequency electric knife, including: a cutting unit (1), an injection unit (2), an electrocoagulation unit (3) and a handle part (5);

The cutting unit (1) includes an electrode part (11);

The injection unit (2) includes an injection needle (21);

The cutting unit (1) is built in the injection unit (2);

Its characteristics are:

The electrocoagulation unit (3) includes a distal metal electrocoagulation ring (31) and a conductive elastic member (32); the metal electrocoagulation ring (31) is arranged at the distal end of the outer sheath (4) In the inner cavity of, the elastic member (32) is elastically crimped on the outer wall of the injection needle (21) or the electrode part (11) to be electrically connected, and allows the injection needle (21) and the electrode Section (11) sliding;

The handle component (5) includes a first handle (51) and a second handle (52), the first handle (51) is configured to control the sliding of the cutting unit (1), and the second handle (52) ) Is configured to control the sliding of the injection unit (2).
The multifunctional high-frequency electrosurgical unit according to any one of claims 1-9, wherein the electrode part (11) comprises a rod-shaped electrode (111) and a diameter at the distal end of the rod-shaped electrode (111). Toward the protrusion (112); the electrode portion (11) is slidably arranged in the injection needle (21), and the radial protrusion (112) is in electrical contact with the inner wall of the injection needle (21).
The multifunctional high-frequency electrosurgical unit according to any one of claims 1-9, wherein the electrode part (11) comprises a rod-shaped electrode (111) and a diameter at the distal end of the rod-shaped electrode (111). When the elastic member (32) is elastically pressed onto the rod-shaped electrode (111), the engagement with the radial protrusion (112) can be used for the radial protrusion (112) ) Check back to prevent the electrode part (11) from being completely retracted into the outer sheath (4).
The multifunctional high-frequency electric knife according to any one of claims 1-9, characterized in that: the cutting unit (1) further comprises a conductive shaft (12) and a connecting piece (13); the electrode part The proximal end of (11) and the distal end of the conductive shaft (12) are fixed and electrically connected by the connector (13); the proximal end of the radial protrusion (112) at the distal end of the electrode portion (11) The end has a guiding member configured to guide the radial protrusion (112) to retract into the injection needle (21) after protruding the injection needle (21).
The multifunctional high-frequency electrosurgical unit according to any one of claims 1-9, characterized in that: the injection unit (2) further comprises an injection needle seat (22) and a middle tube (23); the injection needle (21) It is made of rigid conductive material, has a distal tip, and is in fluid communication with the outer sheath (4) or the middle tube (23) through the injection needle seat (22); the injection needle The seat (22) is arranged at the distal end of the middle tube (23), and the proximal inner surface of the injection needle seat (22) is tapered to the distal end and is configured to guide the electrode part (11) Enter the inner cavity of the injection needle (21).
The multifunctional high-frequency electric knife according to claim 9, characterized in that: the inner cavity of the metal electrocoagulation ring (31) allows the injection needle (21) to slide through, and the metal electrocoagulation ring (31) The inner cavity is provided with an insulating layer (311); the distal end of the metal electrocoagulation ring (31) is flush with the distal end of the outer sheath (4), or the metal electrocoagulation ring (31) It has an end protruding from the distal end surface of the outer sheath (4).