CN111820995A - Device for assisting mucosa peeling operation under endoscope - Google Patents

Device for assisting mucosa peeling operation under endoscope Download PDF

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CN111820995A
CN111820995A CN202010806513.7A CN202010806513A CN111820995A CN 111820995 A CN111820995 A CN 111820995A CN 202010806513 A CN202010806513 A CN 202010806513A CN 111820995 A CN111820995 A CN 111820995A
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solution
magnetic
storage chamber
calcium chloride
mixed
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严小鹏
吕毅
史爱华
马锋
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Chonghao Technology Co.,Ltd.
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First Affiliated Hospital of Medical College of Xian Jiaotong University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/128Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145Hydrogels or hydrocolloids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/442Colorants, dyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/06Flowable or injectable implant compositions

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Abstract

An apparatus for assisting an endoscopic mucosal dissection procedure, comprising: the mixed solution consists of permanent magnetic material particles, sodium alginate solution, calcium chloride solution and medical dye; an injection tool for injecting the mixed solution into the excised mucosal lesion, wherein the mixed solution forms a magnetic gel after injection; the detachable magnetic ring arranged at the end of the endoscope provides a pulling force opposite to the direction of the muscle layer through the magnetic gel and the magnetic attraction between the detachable magnetic ring, so as to be beneficial to the stripping of the mucosa and the muscle layer. The invention provides a pulling force opposite to the direction of the muscular layer by the magnetic attraction of the magnetic gel and the detachable magnetic ring at the end of the endoscope head so as to be beneficial to the peeling of the mucosa and the muscular layer, and has the advantages of convenient operation, reduction of the operation difficulty and the like.

Description

Device for assisting mucosa peeling operation under endoscope
The invention is a Chinese patent: application No. 201711106173.1, application date 2017-11-10, the invention discloses a magnetic gel for assisting an endoscopic mucosal dissection operation, and a preparation and application system thereof.
Technical Field
The invention belongs to the technical field of medical materials, and particularly relates to a device for assisting a mucosa peeling operation under an endoscope.
Background
Endoscopic mucosal dissection is one of the important means for treating gastrointestinal mucosal lesions (including early-stage gastrointestinal cancer, submucosal tumors, giant and flat gastrointestinal polyps, etc.). The key operation in the implementation process of the endoscopic mucosal dissection operation is to separate a mucosal layer from a muscular layer by adopting a submucosal injection method and lift a focus, and then gradually dissect the focus by using an electric knife. The defect is that the focus mucosa lacks the traction force opposite to the muscle layer, so that the gap between the mucosa and the muscle layer is exposed less clearly, and the electric knife is not beneficial to the peeling between the mucosa and the muscle layer.
Disclosure of Invention
In order to overcome the disadvantages of the prior art, the present invention provides a device for assisting a mucosal dissection operation under an endoscope, wherein a magnetic gel is injected into a mucosal lesion, and the magnetic gel in the mucosal lesion is attracted to a magnetic ring configured at the head end of the endoscope during the operation process to provide a traction force opposite to the direction of a muscle layer, so as to facilitate dissection of the mucosa and the muscle layer, and the device has the advantages of convenient operation, reduced operation difficulty, etc.
In order to achieve the purpose, the invention adopts the technical scheme that:
an apparatus for assisting an endoscopic mucosal dissection procedure, comprising:
the mixed solution consists of permanent magnetic material particles, sodium alginate solution with mass concentration of 0.1-5%, calcium chloride solution with mass concentration of 0.1-5% and medical dye;
an injection tool for injecting the mixed solution into the excised mucosal lesion, wherein the mixed solution forms a magnetic gel after injection;
the detachable magnetic ring arranged at the end of the endoscope provides a pulling force opposite to the direction of the muscle layer through the magnetic gel and the magnetic attraction between the detachable magnetic ring, so as to be beneficial to the stripping of the mucosa and the muscle layer.
Further, the mass concentration of the medical dye is 0.5-1%, and the volume ratio of the medical dye to the calcium chloride solution is (1): (1).
In the mixed solution, the permanent magnet material particles are mixed in a sodium alginate solution to form a solution A, a calcium chloride solution to form a solution B, and the solution A and the solution B are prepared into the mixed solution before injection; or in the mixed solution, the permanent magnet material particles are mixed in a sodium alginate solution to form solution A, the medical dye is mixed in a calcium chloride solution to form solution B, and the solution A and the solution B are prepared into the mixed solution before injection.
The injection tool is a double-cavity synchronous injection device and comprises a first storage cavity for storing liquid A and a second storage cavity for storing liquid B, wherein a partition plate is arranged between the first storage cavity and the second storage cavity, so that the liquid A and the liquid B are in a separated state, a first piston is arranged in the first storage cavity, a second piston is arranged in the second storage cavity, the first piston is connected with a handle through a first push rod, the second piston is connected with the handle through a second push rod, the front ends of the first storage cavity and the second storage cavity are provided with conical first joints, the first joints are matched and connected with second joints at the tail end of a conveying pipeline, and the front end of the conveying pipeline is provided with a needle head.
The detachable magnetic ring is sleeved at the end of the endoscope, and a cushion layer is arranged between the detachable magnetic ring and the end of the endoscope.
The medical dye is methylene blue, indigo carmine and other dyes.
The permanent magnetic material particles are formed by ball milling permanent magnetic materials such as neodymium iron boron, ferroferric oxide or samarium cobalt and the like, and the diameter of the particles is micron.
Compared with the prior art, when the magnetic gel is used, the liquid A and the liquid B are quickly and uniformly mixed according to the ratio of (0.1-15) to 1 and then injected into a mucous membrane focus, and the magnetic gel can be formed in a short time. The principle is that after the sodium alginate reacts with multivalent cations (calcium ions) in the calcium chloride, cross-linking bonds are formed among macromolecules and finally gel is formed. The particles of permanent magnetic material are solidified in the gel during the formation of the gel, thereby forming a magnetic gel. In the mucosa dissection operation under the endoscope, after the magnetic gel is injected into a mucosa focus, the endoscope with the magnet at the head end is matched for use, the magnetic attraction is generated between the magnetic gel and the magnet at the head end of the endoscope, and the traction force opposite to the direction of a muscle layer is provided, so that the mucosa and the muscle layer are favorably stripped, and the mucosa dissection operation has the advantages of convenience in operation, reduction of operation difficulty and the like.
Drawings
FIG. 1 is a schematic view showing the construction of the dual chamber simultaneous injection device of the present invention.
Fig. 2 is a schematic view of the installation structure of the detachable magnetic ring of the present invention.
Detailed Description
The embodiments of the present invention will be described in detail below with reference to the drawings and examples.
The invention relates to a magnetic gel for assisting mucosa peeling operation under an endoscope, which is mainly formed by mixing permanent magnet material particles, sodium alginate solution with mass concentration of 0.1-5% and calcium chloride solution with mass concentration of 0.1-5%. The particles of the permanent magnetic material are made of permanent magnetic materials such as neodymium iron boron, ferroferric oxide or samarium cobalt and the like through ball milling, and the diameter of the particles is micron.
In the configuration of the invention, the medical dye with the mass concentration of 0.5-1% can be further included to generate color for convenient identification. The medical dye can be methylene blue, indigo carmine and other dyes.
The preparation application of the gel comprises the following steps:
step 1, adding sterile deionized water into sodium alginate powder treated by a high-pressure steam sterilization method to fully dissolve the sodium alginate powder to prepare a sodium alginate solution with the mass concentration of 1-3%;
step 2, mixing the sterilized permanent magnet material particles with the obtained sodium alginate solution according to the ratio of (1-20) g: (1) fully oscillating and uniformly mixing the mixture according to the proportion of ml to prepare solution A, and storing the solution A for later use;
step 3, adding sterile deionized water into the calcium chloride powder treated by the high-pressure sterilization method for full dissolution to prepare a calcium chloride solution with the mass concentration of 0.1-5% as a solution B; or adding sterile medical dye with mass concentration of 0.5-1% into the obtained calcium chloride solution according to the proportion of 1:1, and mixing to prepare solution B (finally forming color developing magnetic gel);
and 4, when in use, the liquid A and the liquid B are quickly and uniformly mixed according to the volume ratio (0.1-15) to 1, a proper amount of uniformly mixed liquid is injected into the mucosa lesion to be cut according to the size of the lesion, and the uniformly mixed liquid can form magnetic gel in the lesion in a short time.
The magnetic gel of the invention has the following specific application: before mucosa peeling operation under an endoscope, firstly, rapidly and uniformly mixing permanent magnet material particles, sodium alginate solution and calcium chloride solution, then injecting a proper amount of uniform mixing liquid into a mucosa lesion to be cut according to the size of the lesion, and forming magnetic gel in the uniform mixing liquid in the lesion in a short time; then, the magnetic attraction between the magnetic gel and the detachable magnetic ring at the head end of the endoscope provides a pulling force opposite to the direction of the muscle layer, thereby being beneficial to the stripping of the mucosa and the muscle layer.
Based on the material, the invention also provides a corresponding application system (namely the device for assisting the endoscopic mucosa stripping operation, which comprises the following components:
the solution A and the solution B;
an injection means for injecting the solution A and the solution B into the excised mucosal lesion, the solution A and the solution B forming a magnetic gel after injection;
the detachable magnetic ring arranged at the end of the endoscope provides a pulling force opposite to the direction of the muscle layer through the magnetic gel and the magnetic attraction between the detachable magnetic ring, so as to be beneficial to the stripping of the mucosa and the muscle layer.
The injection tool used by the invention is a double-cavity synchronous injection device, and referring to fig. 1, the injection tool comprises a first storage cavity 6 for storing liquid A and a second storage cavity 5 for storing liquid B, a partition plate 12 is arranged between the first storage cavity 6 and the second storage cavity 5, so that the liquid A and the liquid B are in a separated state, a first piston 8 is arranged in the first storage cavity 6, a second piston 7 is arranged in the second storage cavity 5, the first piston 8 is connected with a handle 11 through a first push rod 10, the second piston 7 is connected with the handle 11 through a second push rod 9, a tapered first joint 4 is arranged at the front ends of the first storage cavity 6 and the second storage cavity 5, the first joint 4 is matched and connected with a second joint 3 at the tail end of a conveying pipeline 2, and a needle 1 is arranged at the front end of the conveying pipeline 2.
The prepared liquid A is preloaded in a first storage cavity 6 before use, the liquid B is preloaded in a second storage cavity 5, a partition plate 12 is arranged in front of the first storage cavity 6 and the second storage cavity 5 to enable the liquid A and the liquid B to be in a separated state, when the disposable liquid A and liquid B are used, a first connector 4 is connected with a second connector 3, a handle 11 is pushed, a first push rod 10 and a second push rod 9 push a first piston 8 and a second piston 7 to move synchronously, so that the liquid A in the first storage cavity 6 and the liquid B in the second storage cavity synchronously enter a conveying pipeline 2 through the first connector 4 and the second connector 3 in an equivalent manner, and the liquid A and the liquid B are injected into a mucosal lesion to be excised through a needle 1.
The mounting structure of the detachable magnetic ring is shown in fig. 2, the detachable magnetic ring 22 is sleeved on the endoscope head end 21, and a cushion layer 23 is arranged between the detachable magnetic ring 22 and the endoscope head end 21.
According to the above, the present invention provides the following specific formulation examples:
example 1
A magnetic gel for assisting mucosa peeling operation under endoscope is prepared from the particles of permanent-magnet material, 3% sodium alginate solution, 3% calcium chloride solution and 1% medical dye through mixing.
The preparation process and the application thereof comprise the following steps:
step 1, adding sterile deionized water into sodium alginate powder treated by a high-pressure steam sterilization method to fully dissolve the sodium alginate powder to prepare a 3% sodium alginate solution;
step 2, mixing the sterilized permanent magnet material particles with 3% sodium alginate solution according to the weight ratio of 3 g: fully oscillating and uniformly mixing 6ml of the mixture to prepare solution A, and storing the solution A for later use;
step 3, adding sterile deionized water into the calcium chloride powder treated by the high-pressure sterilization method to fully dissolve the calcium chloride powder to prepare a 3% calcium chloride solution;
step 4, 1% of sterile medical dye is added according to the proportion of 1 ml: adding 1ml of the mixture into 3 percent calcium chloride solution, uniformly mixing to prepare solution B, and storing for later use;
and 5, rapidly and uniformly mixing the solution A and the solution B according to the ratio of 1:1 when the liquid A and the solution B are used, injecting a proper amount of A, B uniformly mixed solution into the mucous membrane focus to be cut according to the size of the focus, and forming a colored magnetic gel in a short time in the focus.
Example 2
A magnetic gel for assisting mucosa dissection operation under endoscope is prepared from permanent magnetic material particles, 1% sodium alginate solution, 1% calcium chloride solution, and 0.5% medical dye by mixing.
The preparation process and the application thereof comprise the following steps:
step 1, adding sterile deionized water into sodium alginate powder treated by a high-pressure steam sterilization method to fully dissolve the sodium alginate powder to prepare a 1% sodium alginate solution;
step 2, mixing the sterilized permanent magnet material particles with 1% sodium alginate solution according to the weight ratio of 2 g: fully oscillating and uniformly mixing the mixture in a proportion of 3ml to prepare solution A, and storing the solution A for later use;
step 3, adding sterile deionized water into the calcium chloride powder treated by the high-pressure sterilization method to fully dissolve the calcium chloride powder to prepare a 1% calcium chloride solution;
step 4, 0.5% sterile medical dye 2 ml: adding 2ml of the mixture into 1% calcium chloride solution, mixing uniformly to prepare solution B, and storing for later use;
and 5, rapidly and uniformly mixing the solution A and the solution B according to the ratio of 2:1 when the liquid A and the solution B are used, injecting a proper amount of A, B uniformly mixed solution into the mucous membrane focus to be cut according to the size of the focus, and forming a colored magnetic gel in a short time in the focus.
Example 3
A magnetic gel for assisting mucosa dissection operation under endoscope is prepared from permanent magnetic material particles, 1.5% sodium alginate solution, and 1.5% calcium chloride solution by mixing.
The preparation process and the application thereof comprise the following steps:
step 1, adding sterile deionized water into sodium alginate powder treated by a high-pressure steam sterilization method to fully dissolve the sodium alginate powder to prepare 1.5% sodium alginate solution;
step 2, mixing the sterilized permanent magnet material particles with 1.5% sodium alginate solution according to the weight ratio of 2 g: fully oscillating and uniformly mixing the mixture in a proportion of 3ml to prepare solution A, and storing the solution A for later use;
step 3, adding sterile deionized water into the calcium chloride powder treated by the high-pressure sterilization method to fully dissolve the calcium chloride powder to prepare a 1.5 percent calcium chloride solution;
step 4, 0.5% sterile medical dye 2 ml: adding 2ml of the mixture into 1.5 percent calcium chloride solution, uniformly mixing to prepare solution B, and storing for later use;
and 5, rapidly and uniformly mixing the solution A and the solution B according to the ratio of 3:1 when the liquid A and the solution B are used, injecting a proper amount of A, B uniformly mixed solution into the mucous membrane focus to be cut according to the size of the focus, and forming a colored magnetic gel in a short time in the focus.

Claims (7)

1. A device for assisting an endoscopic mucosal dissection procedure, comprising:
the mixed solution consists of permanent magnetic material particles, sodium alginate solution with mass concentration of 0.1-5%, calcium chloride solution with mass concentration of 0.1-5% and medical dye;
an injection tool for injecting the mixed solution into the excised mucosal lesion, wherein the mixed solution forms a magnetic gel after injection;
the detachable magnetic ring arranged at the end of the endoscope provides a pulling force opposite to the direction of the muscle layer through the magnetic gel and the magnetic attraction between the detachable magnetic ring, so as to be beneficial to the stripping of the mucosa and the muscle layer.
2. The device of claim 1, wherein in the mixing solution, the particles of the permanent magnet material are mixed in a sodium alginate solution as solution A, a calcium chloride solution as solution B, and the solution A and the solution B are prepared to form the mixing solution before injection; or in the mixed solution, the permanent magnet material particles are mixed in a sodium alginate solution to form solution A, the medical dye is mixed in a calcium chloride solution to form solution B, and the solution A and the solution B are prepared into the mixed solution before injection.
3. The device of claim 1, wherein the injection tool is a dual chamber simultaneous injection device comprising a first storage chamber for storing liquid A and a second storage chamber for storing liquid B, a partition plate is provided between the first storage chamber and the second storage chamber to separate liquid A and liquid B, a first piston is provided in the first storage chamber, a second piston is provided in the second storage chamber, the first piston is connected to the handle through a first push rod, the second piston is connected to the handle through a second push rod, a first tapered joint is provided at the front end of the first storage chamber and the second storage chamber, the first joint is engaged with a second joint at the tail end of the delivery line, and a needle is provided at the front end of the delivery line.
4. The device as claimed in claim 1, wherein the detachable magnetic ring is sleeved at the endoscope head end, and a cushion layer is arranged between the detachable magnetic ring and the endoscope head end.
5. The device according to claim 1, wherein the mass concentration of the medical dye is 0.5-1%, and the volume ratio of the medical dye to the calcium chloride solution is (1): (1).
6. The device of claim 5, wherein the medical dye is methylene blue or indigo carmine.
7. The device according to claim 1, wherein the particles of permanent magnetic material are formed by ball milling permanent magnetic materials such as neodymium iron boron, ferroferric oxide or samarium cobalt, and the diameter of the particles is micron.
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