CN219000537U

CN219000537U - Mirror knife device

Info

Publication number: CN219000537U
Application number: CN202222738570.3U
Authority: CN
Inventors: 马骁萧; 朱海洋; 冯宇
Original assignee: Jingwei Zhiyuan Medical Technology Wuhan Co ltd
Current assignee: Jingwei Zhiyuan Medical Technology Wuhan Co ltd
Priority date: 2022-10-18
Filing date: 2022-10-18
Publication date: 2023-05-12
Anticipated expiration: 2032-10-18

Abstract

The utility model provides a mirror knife device, which comprises a visual catheter, a multi-cavity incision catheter and a guide wire, wherein the visual catheter comprises a fiber mirror handle and a fiber mirror catheter, a handle wire and an external fiber bundle, the tail end of the handle wire is connected with a handle wire navigation plug, the tail end of the external fiber bundle is connected with a fiber joint, and a catheter end cap at the end part of the fiber mirror catheter comprises a light guide element and an observation element; the multi-cavity incising knife catheter comprises a rear-end multi-cavity incising knife catheter operation part and a front-end multi-cavity incising knife catheter section, and the visualization catheter and the guide wire are respectively inserted into the multi-cavity incising knife catheter through an inlet A and an inlet B. The utility model provides a mirror sword device combines visual pipe, multicavity incision catheter and seal wire, has improved the operation degree of difficulty of ERCP operation among the prior art, has reduced operator's operating time, makes ERCP operation simple process and operation risk low.

Description

Mirror knife device

Technical Field

The utility model belongs to the technical field of endoscopes, and particularly relates to a mirror knife device.

Background

Retrograde Cholangiopancreatography (ERCP) by endoscope refers to a technique of inserting a duodenal mirror to a duodenal drop portion to find a duodenal papilla, inserting a contrast catheter into a papilla opening portion from a biopsy tube, and injecting a contrast agent to an x-ray film to display the cholangiopancreatography.

Selective intubation is the basis for successful ERCP diagnosis and treatment. The catheter is inserted into the nipple through the biopsy hole, the angle of the catheter and the forceps lifting device are adjusted, the catheter is vertical to the nipple opening, and the catheter is inserted into the nipple. Because the head of the duodenal papilla is very narrow, the direct insertion of the catheter into the papilla is difficult, high risk of bleeding and perforation of the pancreatic bile duct exists, once the risk of life of a patient occurs, a guide wire is generally inserted firstly in clinic at present, the diameter of the guide wire is generally 0.025 inch or 0.035 inch, the guide wire is made of metal materials, the front end is provided with a soft head, the head can be developed under X rays, and a doctor inserts the guide wire into the duodenal papilla and enters the correct direction (pancreatic duct or bile duct) and then inserts the catheter.

At present, a catheter with a cutting function (also called a duodenal papilla cutting knife) is generally used for inserting and cutting the duodenal papilla, so that the diameter of a channel is enlarged, and a therapeutic instrument and a stone are conveniently inserted subsequently. A guide wire cavity is arranged in the middle of the incision knife, and a guide wire is required to be placed in the guide wire cavity when the incision knife is inserted, so that the incision knife advances along the direction of the guide wire, and then the incision knife enters a bile duct or a pancreatic duct. Thus, the general clinical procedures of current ERCP surgery are:

(1) Inserting a duodenal mirror into the duodenal drop portion to find a duodenal papilla;

(2) Inserting a guide wire from a biopsy duct of the duodenum scope, and inserting the guide wire into a pancreatic duct or a bile duct through a duodenal papilla under the guidance of X-rays;

(3) Inserting a duodenal papilla incision knife along a biopsy pore canal of the duodenal mirror (keeping a guide wire positioned in a guide wire cavity of the incision knife), incising the duodenal papilla to a proper size, and then continuing to insert the incision knife until the incision knife enters a target position of a bile duct or a pancreatic duct;

(4) At this point the cannulation has been completed and the physician can perform the subsequent surgical procedure with the assistance of the guidewire and the incision.

In the current operation of the prior art, the second step is to insert the guide wire into the pancreatic duct or bile duct, so that the risk is highest, the difficulty is greatest, and the significant difficulty limits the development of ERCP operation; meanwhile, frequent instrument insertion actions can be performed during subsequent instrument exchange. The main risk points for these operations are:

(1) Misplaced, the bile duct is intended to be accessed but the pancreatic duct is accessed by mistake (or vice versa), and serious operation complications such as severe pancreatitis and the like can be caused, so that the life of a patient is endangered;

(2) Instead of inserting the bile duct or pancreatic duct, the bile duct wall or pancreatic duct wall is pierced, so that perforation is caused, and if the perforation cannot be found and treated immediately, the life of a patient is also endangered.

(3) In the process of exchanging other instruments, the following operation risks exist, namely, a guide wire is lost, and the target position finding operation is needed to be performed again; b. the secondary injury to the tissue of the patient is performed through multiple interpenetration; c. increasing the operative time of the operator.

The present utility model therefore proposes a knife device for ERCP against a series of risks associated with the insertion of the guide wire and subsequent manipulation during ERCP operation.

Disclosure of Invention

Aiming at the problems existing in the prior art, the utility model adopts the following technical scheme for solving the problems existing in the prior art:

a mirror knife device, characterized in that: the visual catheter comprises a fiber optic handle 2, a fiber optic catheter 1 positioned at the front end of the fiber optic handle 2, a handle wire 3 positioned at the rear end of the fiber optic handle 2 and an external optical fiber bundle 4, wherein the tail end of the handle wire 3 is connected with a handle wire navigation plug 5 and an external power supply, the tail end of the external optical fiber bundle 4 is connected with an optical fiber connector 6 and an external light source, the end part of the fiber optic catheter 1 is provided with a catheter end cap 7, and the catheter end cap 7 comprises an end cap body 10, a light guide element 8 positioned in the end cap body and an observation element 9;

the multi-cavity incision catheter comprises a rear-end multi-cavity incision catheter operation part 22 and a front-end multi-cavity incision catheter tube section 23, wherein the multi-cavity incision catheter operation part 22 comprises a support handle 13 and an operation handle 14 sleeved on the support handle, the middle part of the operation handle 14 is connected with an electrode knife wire 16 along the catheter direction, an electrode interface 15 is arranged on the operation handle, the electrode knife wire 16 is connected with an external electrode through the electrode interface 15, the front-end catheter tube section of the operation handle is provided with two inlets, and an inlet A11 and an inlet B12; two instrument channels are arranged in the multi-cavity incision knife catheter, an instrument channel A20 and an instrument channel B21 are arranged in the multi-cavity incision knife catheter, the instrument channel A20 is communicated with the inlet A11, and the instrument channel B21 is communicated with the inlet B12;

the visualization catheter and guidewire 24 are inserted into the multi-lumen osteotome catheter through inlet a11 and inlet B12, respectively. The guide wire 24 is mainly used with a multi-lumen incisor catheter, and when the multi-lumen incisor catheter enters the papillary opening of the duodenum or the bile duct, the guide wire is inserted, and meanwhile, the multi-lumen incisor catheter is pushed along the guide wire, so that the catheter can enter smoothly.

The front end 18 of the multi-cavity incision knife catheter is made of flexible and bendable materials, the electrode knife wire 16 is positioned at the front end 18 of the multi-cavity incision knife catheter, part of the electrode knife wire is exposed outside the catheter, the rest part of the electrode knife wire is positioned in a knife wire channel in the catheter, one end of the electrode knife wire 16 is fixed at the front end of the catheter, and the other end of the electrode knife wire is connected with the operating handle 14. The multicavity incising knife catheter is matched with high-frequency operation equipment for use, the operating part of the multicavity incising knife catheter is connected with the electrode of the high-frequency operation equipment through the electrode interface 15, when in actual use, the multicavity incising knife catheter is rotated to a required position, and the exposed electrode knife wire 16 at the front end of the catheter forms a certain angle by pulling the operating handle 14, so that the bile duct sphincter operation is completed.

The visual catheter is connected with an image processor through an external optical fiber bundle 4, the image processor is connected with an image processor display, the image processor provides a light source for the visual catheter, processes image information observed by an observation original 9, and displays the image information through the image processor display. The image processor and the image processor display use the prior art, such as an imaging controller host and a display device in the patent application publication No. CN114569874A, an imaging controller host and an image processing method applied to a visual guide wire.

The wavelength of the external light source of the external optical fiber bundle 4 is adjustable, so that the requirements of visible light and infrared light can be met, the external light source and the external optical fiber bundle can be switched simultaneously, the wavelength range of the external visible light source is 380-460 nm, and the spectrum range of the external infrared light is 780-840 nm.

The endoscopic scalpel device comprises a visual catheter, a multi-cavity incising catheter and a guide wire, wherein the visual catheter, the multi-cavity incising catheter and the guide wire are in a matching relationship in clinical application, the multi-cavity incising catheter is firstly inserted into a designated position of a duodenal endoscope instrument channel, and the visual over-selected catheter and the guide wire are respectively pushed to the designated position sequentially according to requirements through the instrument channel in the multi-cavity incising catheter.

The specific use method of the mirror knife device comprises the following steps:

step 1, delivering the duodenum mirror 25 to a designated position;

step 2, a multi-cavity incision knife catheter is sent into the instrument channel along the instrument channel of the duodenum scope 25 to the opening of the duodenal papilla;

step 3, respectively conveying the visualization catheter and the guide wire to two inlets of the multi-cavity incision catheter;

step 4, guiding the front end of the multi-cavity incision knife catheter to be aligned with the papillary muscle opening by adjusting the knife bow of the electrode knife wire of the multi-cavity incision knife catheter, and then sequentially pushing the guide wire and the visual catheter into the papillary muscle; if the papillary muscle opening is too small, the multi-cavity incision knife catheter incision knife function needs to be opened for sphincter operation (otherwise, the multi-cavity incision knife catheter can be directly pushed in);

and 5, confirming that the operation is finished, enabling the multi-cavity incision knife catheter to smoothly enter the papillary muscle opening, opening the image processor host to enable the visual catheter to start working, selectively outputting a required light source by the external host, and identifying and guiding the bile duct through a fluorescent signal, so that the fact that the guide wire can smoothly find the alignment direction is confirmed.

In the prior art ERCP operation, in the clinical practical operation process, a plurality of difficulties 1 are existed, the difficult nipple and the beginning of the postoperative nipple are not found well; 2. the tissue is accessed through the papillary muscle opening, then the guide wire is inserted to find the position, the blind insertion is difficult to find the position once, and the blind insertion can lead to tissue edema and damage to increase the risks of various complications; 3. the operator can feel tired of hands and bodies when standing for a long time; 4. the prior operation process needs frequent exchange of instruments, which can be used for repeatedly inserting the papillary muscle opening and can cause repeated damage to tissues; the utility model provides a mirror sword device through combining visual pipe, multicavity incision catheter and seal wire, has solved above-mentioned technical problem, has improved the operation degree of difficulty and has reduced operator's operating time, makes ERCP operation simple process and operation risk low.

Drawings

FIG. 1 is a schematic diagram of the overall structure of the mirror knife device of the present utility model;

FIG. 2 is a schematic view of a visual catheter structure;

FIG. 3 is an enlarged view of the catheter end cap of FIG. 2;

FIG. 4 is a schematic view of the overall structure of the multi-cavity cutting blade;

FIG. 5 is a schematic view of a multi-lumen cutting catheter;

FIG. 6 is a cross-sectional view of the front end of a multi-lumen cutting catheter;

FIG. 7 is an enlarged view of the front end of the multi-lumen cutting catheter;

FIGS. 8-14 are views showing the use of the mirror knife device of the present utility model;

wherein: 1-optical fiber mirror catheter, 2-optical fiber mirror handle, 3-handle wire, 4-external optical fiber bundle, 5-handle wire navigation plug, 6-optical fiber connector, 7-catheter end cap, 8-catheter original, 9-observation original and 10-end cap body; 11-entry A, 12-entry B, 13-support handle, 14-operating handle, 15-electrode interface, 16-electrode wire, 17-exposed electrode wire, 18-multi-lumen osteotomy catheter tip, 19-wire channel, 20-instrument channel A, 21-instrument channel B, 22-multi-lumen osteotomy catheter manipulation, 23-multi-lumen osteotomy catheter, 24-guidewire, 25-duodenoscope, 26-lithotripsy fiber optic or other instrument.

Detailed Description

The technical scheme of the utility model is further specifically described by the following embodiments and with reference to the accompanying drawings, as shown in fig. 1, the endoscope knife device comprises a visualization catheter, a multi-cavity incision catheter and a guide wire, as shown in fig. 2, the visualization catheter comprises an optical fiber mirror handle 2, an optical fiber mirror catheter 1 positioned at the front end of the optical fiber mirror handle 2, a handle wire 3 and an external optical fiber bundle 4 positioned at the rear end of the optical fiber mirror handle 2, the tail end of the handle wire 3 is connected with a handle wire navigation plug 5, an external power supply, the tail end of the external optical fiber bundle 4 is connected with an optical fiber connector 6, an external light source, and the end part of the optical fiber mirror catheter 1 is provided with a catheter end cap 7;

as shown in fig. 3, the catheter end cap 7 comprises an end cap body 10, a light guide element 8 and a viewing element 9 which are positioned in the cap body; the visualization conduit is connected with an image processor and an image processor display through an external optical fiber bundle 4, the image processor provides a light source for the visualization conduit, processes image information observed by an observation original 9, and displays the image information through the image processor display. The image processor and the image processor display use the prior art, such as the imaging controller host and the display device in the patent application publication No. CN114569874A, an imaging controller host and an image processing method applied to a visual guide wire. The wavelength of the external light source connected with the external optical fiber bundle 4 is adjustable, so that the requirements of visible light and infrared light can be met, the visible light source and the infrared light can be switched simultaneously, the wavelength range of the visible light source is 380-460 nm, and the spectrum range of the infrared light is 780-840 nm.

As shown in fig. 4-7, the multi-cavity incising catheter comprises a rear-end multi-cavity incising catheter operation part 22 and a front-end multi-cavity incising catheter tube section 23, wherein the multi-cavity incising catheter operation part 22 comprises a support handle 13 and an operation handle 14 sleeved on the support handle, the middle part of the operation handle 14 is connected with an electrode knife wire 16 along the catheter direction, an electrode interface 15 is arranged on the operation handle, the electrode knife wire 16 is connected with an external electrode through the electrode interface 15, and the front-end catheter section of the operation handle is provided with two inlets, an inlet A11 and an inlet B12; two instrument channels are arranged in the multi-cavity incision knife catheter, an instrument channel A20 and an instrument channel B21 are arranged in the multi-cavity incision knife catheter, the instrument channel A20 is communicated with the inlet A11, and the instrument channel B21 is communicated with the inlet B12; the front end 18 of the multi-cavity incision knife catheter is made of flexible and bendable materials, the electrode knife wire 16 is positioned at the front end 18 of the multi-cavity incision knife catheter, part of the electrode knife wire is exposed outside the catheter, the rest part of the electrode knife wire is positioned in a knife wire channel in the catheter, one end of the electrode knife wire 16 is fixed at the front end of the catheter, and the other end of the electrode knife wire is connected with the operating handle 14. The multicavity incising knife catheter is matched with high-frequency operation equipment for use, the operating part of the multicavity incising knife catheter is connected with the electrode of the high-frequency operation equipment through the electrode interface 15, when in actual use, the multicavity incising knife catheter is rotated to a required position, and the exposed electrode knife wire 16 at the front end of the catheter forms a certain angle by pulling the operating handle 14, so that the bile duct sphincter operation is completed.

Visualization catheter and guidewire 24 are inserted into the multi-lumen osteotome catheter through inlet a11 and inlet B12, respectively. The guide wire 24 is mainly used with a multi-lumen incisor catheter, and when the multi-lumen incisor catheter enters the papillary opening of the duodenum or the bile duct, the guide wire is inserted, and meanwhile, the multi-lumen incisor catheter is pushed along the guide wire, so that the catheter can enter smoothly.

In practical clinical application, three instruments are used in combination, and the functions of the three instruments are as follows: the catheter is visualized for identification and viewing. The visual catheter is used with an image processor, which has three output modes: output visible light, output near infrared light, or output both visible and near infrared light. When the image processor outputs visible light, an observation function is realized; when the near infrared light is output, the recognition function is realized. When two kinds of light are output simultaneously, the identification function and the observation function are realized simultaneously. The identification function of the visual catheter is that in the actual clinical application process, the guide wire is inserted into the bile duct, the biliary tract opening is difficult to distinguish by naked eyes, the guide wire insertion work is required to be smoothly completed, the guide is required to be carried out by other mediums, and the bile duct opening can be identified by using near infrared fluorescence imaging; and the visual catheter has the observation function of outputting visible light through the image processor, realizing the operation of inserting the guide wire under the visual condition, and diagnosing or treating the patient according to the requirement.

The multi-cavity incision knife catheter has the functions of: providing working access to other instruments, providing a water injection access, and dissecting the bile duct sphincter. The multicavity incising knife catheter is used with high frequency operation equipment in a matching way, the catheter is connected with the high frequency equipment through an electrode interface, when in actual use, the multicavity incising knife catheter is rotated to a required position, the exposed electrode knife wire 16 is made to form a certain angle by pulling the operating handle 14, and an electrode is connected through the electrode interface 15, so that bile duct sphincter operation is completed. The handle end of the multi-cavity incision knife catheter is provided with two or more working channels, and the two or more working channels can be matched with instruments to select different instrument channels according to the size specification for entering, and meanwhile, in order to meet the surgical requirements of the instruments, water injection operation can be performed through the instrument channels when needed.

The guide wire 24 is mainly used for guiding and supporting. When the multi-cavity incision knife catheter enters the opening of the papillary muscle of the duodenum or the bile duct, the guide wire is inserted, and meanwhile, the multi-cavity incision knife catheter is pushed into the guide wire, so that the catheter can be ensured to enter smoothly; the supporting function of the guide wire is mainly embodied in the following two aspects, and when the guide wire is excessively bent, the guide wire has the capability of exerting force in the axial direction without bending; the ability to advance against resistance as the guidewire is advanced.

The device of the utility model comprises the following using processes: 1. first, the duodenum mirror 25 is sent to a designated position; 2. then the multi-cavity incision knife catheter is sent out of the instrument channel along the duodenal endoscope instrument channel to the opening of the duodenal papilla; 3. then the visualized catheter and the guide wire are respectively sent to the opening of the multi-cavity incision catheter; 4. then the cutter bow of the multi-cavity incision knife catheter is adjusted to guide the front end of the multi-cavity incision knife catheter to be aligned with the papillary muscle opening, and then the guide wire and the visual selection catheter are sequentially pushed into the papillary muscle; 4.1. if the papillary muscle opening is too small, the multi-cavity incision knife catheter incision knife function needs to be opened for sphincter operation (otherwise, the multi-cavity incision knife catheter can be directly pushed in); 5. the operation is confirmed to be finished, the multi-cavity incision knife catheter can smoothly enter the papillary muscle opening, the image processor host can be opened at the moment to enable the catheter to start working, the external host can simultaneously output two lights (or selectively output the modes of the lights), and the bile duct is identified and guided through fluorescent signals, so that the fact that the guiding guide wire can smoothly find the direction is confirmed.

As shown in fig. 8 to 14, the steps for performing ERCP operation based on the scalpel device of the present utility model are as follows:

step 1: find duodenal papillary opening: aiming at the situation that the head of a difficult nipple and a postoperative nipple is not found well, an opening is searched through a fluorescent mode;

the specific flow is as follows: the nipple can be in the form of nipple, hemisphere, flat, and less common bell-shaped, mitral-shaped, lobed, and grooved. If the nipple is not seen clearly, the blind intubation tube is damaged, and the intubation tube is difficult. Therefore, the opening is searched by adopting a fluorescence mode, indocyanine green is firstly subjected to intravenous injection, the indocyanine green is combined with some components in plasma, enters into liver blood sinuses along with liver blood flow, is rapidly and efficiently absorbed by liver cells, is secreted into bile in a free form from the liver cells, and is discharged through the opening of the papillary muscle of the duodenum. The indocyanine green can be excited by external light with the wavelength of 780-840 nm, emits near infrared light with the wavelength of about 800nm, can be accepted by an indocyanine green fluorescent imaging system and can be displayed in imaging equipment, so that papillary muscle openings can be found under direct vision.

Step 2, completing bile duct intubation: after the papillary muscle opening is found based on the step 1, the guide wire is pushed forward along the fluorescent direction through observation of the imaging equipment, so that the intubation of the bile duct is completed.

Step 3, diagnosing bile duct of patient: after the bile duct intubation is completed based on the step 2, pushing the multi-cavity incision knife catheter to a required position along the guide wire, then withdrawing the guide wire for a certain length to ensure that the guide wire does not block the view of the front end of the visual selection catheter, switching the output light path mode of the main machine of the visual selection catheter to a visible light mode, and completing diagnosis work on the bile duct of a patient through the visual selection catheter;

if it is necessary to perform diagnostic tasks with other instruments, the multi-lumen osteotome catheter may be retained to ensure that the established passageway is not lost (repeated cannulation or guidewire insertion may be avoided), and the visual selection catheter or guidewire in the multi-lumen osteotome catheter instrument passageway may be withdrawn, pushing other instruments as desired. And 4, after the diagnosis is finished based on the step 3, when the patient needs to be treated, withdrawing the guide wire, and penetrating a lithotripsy optical fiber or other instruments 26 into the instrument hole of the multi-cavity incision knife catheter. The actual clinical problem is resolved by the use of a multi-lumen incision knife catheter, a visual catheter, and a lithotripsy fiber or other instrument 26 in combination.

The protective scope of the utility model is not limited to the embodiments described above, but it will be apparent to those skilled in the art that various modifications and variations can be made in the present utility model without departing from the scope and spirit of the utility model. It is intended that the present utility model also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A mirror knife device, characterized in that: the surgical endoscope comprises a visual catheter, a multi-cavity incision catheter and a guide wire, wherein the visual catheter comprises a fiber optic handle (2), a fiber optic catheter (1) positioned at the front end of the fiber optic handle (2), a handle wire (3) and an external optical fiber bundle (4) positioned at the rear end of the fiber optic handle (2), and the tail end of the handle wire (3) is connected with a handle wire navigation plug (5) for externally connecting a power supply; the tail end of the external optical fiber bundle (4) is connected with an optical fiber connector (6) and is used for externally connecting a light source, a catheter end cap (7) is arranged at the end part of the optical fiber catheter (1), and the catheter end cap (7) comprises an end cap body (10), a light guide element (8) and an observation element (9) which are positioned in the end cap body (10);

the multi-cavity incision catheter comprises a rear-end multi-cavity incision catheter operation part (22) and a front-end multi-cavity incision catheter tube section (23), the multi-cavity incision catheter operation part (22) comprises a support handle (13) and an operation handle (14) sleeved on the support handle (13), the middle part of the operation handle (14) is connected with an electrode knife wire (16) along the catheter direction, an electrode interface (15) is arranged on the operation handle (14), the electrode knife wire (16) is connected with an external electrode through the electrode interface (15), and two inlets are formed in the front-end catheter section of the operation handle (14): an inlet A (11) and an inlet B (12); two instrument channels are arranged in the multi-cavity incision knife catheter: an instrument channel A (20) and an instrument channel B (21), wherein the instrument channel A (20) is communicated with the inlet A (11), and the instrument channel B (21) is communicated with the inlet B (12);

the visualization catheter is inserted into the multi-cavity incision catheter through an inlet A (11) and the guide wire (24) through an inlet B (12) respectively.

2. A mirror knife apparatus as claimed in claim 1, wherein: the electrode knife wire (16) is positioned at the front end (18) of the multi-cavity incision knife catheter and is partially exposed outside the catheter, the rest part of the electrode knife wire is positioned in a knife wire channel in the catheter, one end of the electrode knife wire (16) is fixed at the end part of the front end (18) of the catheter, and the other end of the electrode knife wire is connected with the operating handle (14).

3. A mirror knife apparatus as claimed in claim 1, wherein: the visual catheter is connected with the image processor through the external optical fiber bundle (4), the image processor is connected with the image processor display, the image processor provides a light source for the visual catheter and processes image information observed by the observation original (9) and displays the image information through the image processor display.

4. A mirror knife apparatus as claimed in claim 1, wherein: the external optical fiber bundle (4) is adjustable in external light source wavelength, the external visible light source wavelength range is 380-460 nm, and the external infrared light spectrum range is 780-840 nm.