CN111956299A - Adjustable stone removal sacculus - Google Patents

Adjustable stone removal sacculus Download PDF

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Publication number
CN111956299A
CN111956299A CN202010714351.4A CN202010714351A CN111956299A CN 111956299 A CN111956299 A CN 111956299A CN 202010714351 A CN202010714351 A CN 202010714351A CN 111956299 A CN111956299 A CN 111956299A
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CN
China
Prior art keywords
balloon
parts
adjustable
pushing mechanism
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
CN202010714351.4A
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Chinese (zh)
Inventor
沈坤
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Zhejiang Tongxuan Medical Technology Co Ltd
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Zhejiang Tongxuan Medical Technology Co Ltd
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Priority to CN202010714351.4A priority Critical patent/CN111956299A/en
Publication of CN111956299A publication Critical patent/CN111956299A/en
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L45/00—Compositions of homopolymers or copolymers of compounds having no unsaturated aliphatic radicals in side chain, and having one or more carbon-to-carbon double bonds in a carbocyclic or in a heterocyclic ring system; Compositions of derivatives of such polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/18—Oxygen-containing compounds, e.g. metal carbonyls
    • C08K3/24—Acids; Salts thereof
    • C08K3/26—Carbonates; Bicarbonates
    • C08K2003/265—Calcium, strontium or barium carbonate
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2205/00—Polymer mixtures characterised by other features
    • C08L2205/03—Polymer mixtures characterised by other features containing three or more polymers in a blend
    • C08L2205/035—Polymer mixtures characterised by other features containing three or more polymers in a blend containing four or more polymers in a blend

Abstract

The invention relates to the field of medical instruments, in particular to an adjustable calculus removal balloon. An adjustable lithotomy balloon comprises a balloon, a catheter, a pushing mechanism and a balloon filling opening; one end of the catheter is coated with a balloon, and the other end of the catheter is provided with a pushing mechanism; the balloon filling opening is arranged between the balloon and the pushing mechanism and used for injecting and discharging air or normal saline. By adopting the adjustable calculus removing saccule, the propelling mechanism is arranged, so that the saccule not only has the sealing and fixing effects, but also can adjust the size of the saccule, the device is very simple to operate, the operation process is simplified, the size stability of the saccule is high, and the stability of the treatment process is ensured.

Description

Adjustable stone removal sacculus
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to an adjustable calculus removal balloon.
Background
The lithotomy balloon is a common accessory instrument when ERCP lithotomy is performed. The stone-taking saccule belongs to a catheter-shaped medical apparatus, and the inflatable saccule is fixed at the far end of a catheter. Prior to use, the balloon is in a deflated and folded state. Generally, in an operation, a calculus removing balloon is pushed to a narrow part along a duodenoscope lumen under the guidance of a guide wire, then a pressure device is filled in the balloon outside a catheter tail end connector to enable the balloon wall to be completely attached to the inner wall of a bile duct and the like, and a doctor drags the calculus in vitro by developing the calculus removing balloon to separate the calculus from a focus part of the biliary duct.
The treatment method comprises the steps of firstly conveying the saccule to a diseased part, expanding the saccule to enable the lumen of the diseased part to be expanded to realize pre-expansion so as to prepare for completing the treatment of the stenotic diseases; the operation process of the treatment scheme is very complicated, so that the time of the whole operation process is increased, and the physical health of patients and operators is influenced. In addition, these balloons are easily deformed when pressurized and increase in diameter significantly, causing the balloon to be over-stretched during the treatment process, which can interfere with the performance of the procedure. Therefore, it is an urgent technical problem to be solved by those skilled in the art to provide an adjustable lithotomy balloon capable of simplifying the surgical procedure.
Disclosure of Invention
In order to solve the technical problem, the invention provides an adjustable calculus removing balloon in a first aspect, which comprises a balloon, a catheter, a pushing mechanism and a balloon filling opening; one end of the catheter is coated with a balloon, and the other end of the catheter is provided with a pushing mechanism; the balloon filling opening is arranged between the balloon and the pushing mechanism and used for injecting and discharging air or normal saline.
In order to better realize the purpose of the invention, a balloon filling opening is arranged between the balloon and the pushing mechanism, the balloon filling opening is relatively far away from one end of the balloon, and is closer to one end of the pushing mechanism, so that water or air can be conveniently injected, and the pushing mechanism can be used for sealing to prevent water or air from leaking.
In a preferred or alternative embodiment, a water delivery channel and an output channel are provided within the conduit.
In a preferred or alternative embodiment, the water delivery passage communicates between the balloon and the balloon inflation port.
In a preferred or alternative embodiment, the water delivery channel and the outlet channel are arranged concentrically, and the outlet channel has a smaller inner diameter than the water delivery channel.
Generally, in order to avoid compression injury to a patient caused by too fast shrinkage of the balloon during water pumping, the inner diameter of the output channel is smaller than that of the water delivery channel as much as possible, so that water in the balloon flows out slowly.
In a preferred or alternative embodiment, the pushing mechanism comprises an outer rotating support and an inner rotating support in threaded fit with the outer rotating support, and the tightness of the pushing mechanism can be adjusted by rotating the outer rotating support.
The outer rotary support is provided with internal threads, and the inner rotary support is provided with external threads; the external rotating support can move back and forth through thread matching, when the external rotating support is screwed, the compression piece moves towards the direction close to the elastic sealing piece to extrude the elastic sealing piece, so that the elastic sealing piece deforms to play a role in fastening and sealing, water or air in the balloon cannot leak out, and the stability of the stone removal balloon is maintained; when the external rotation support is unscrewed, the compression piece loses the extrusion effect on the elastic sealing piece, so that water or air in the balloon leaks to a certain degree, when the balloon reaches a required state, the external rotation support can be screwed again to realize sealing, and finally adjustability is realized.
In a preferred or alternative embodiment, an elastic sealing element is arranged in the inner rotating support, and a compression element is arranged in the outer rotating support; the compression piece is pressed on the elastic sealing piece.
The elastic sealing element and the compression element are both of circular structures and are respectively fixed on the inner rotating support and the outer rotating support.
In a preferred or alternative embodiment, the resilient seal is a compressible rubber or silicone.
In a preferred or alternative embodiment, the compression member is a metal compression ring.
In a preferred or alternative embodiment, the catheter is further provided with a guidewire inlet.
In a preferred or alternative embodiment, the balloon is made of a silicone rubber composite material.
Compared with the prior art, the invention has the following beneficial effects:
the adjustable calculus removing balloon provided by the invention has the advantages that the balloon is sealed and fixed by the aid of the pushing mechanism, the size of the balloon can be adjusted, the balloon is made to have high size stability by selecting materials of the balloon, the device is very simple to operate, the operation process is simplified, and the stability of the treatment process is guaranteed.
Drawings
In order to more clearly illustrate the technical solution of the present invention, the drawings used in the embodiments will be briefly described below, the drawings described below are only some embodiments of the present invention, and it is obvious to those skilled in the art that other drawings can be obtained based on the drawings without creative efforts.
FIG. 1 is a schematic cross-sectional view of a catheter with an adjustable lithotomy balloon according to an embodiment of the invention;
FIG. 2 is a schematic structural view of an adjustable lithotomy balloon in example 1 of the present invention;
the numbering in the figure is as follows:
1. a balloon; 2. a conduit; 21. a water delivery channel; 22. an output channel; 3. a pushing mechanism; 31. an outer rotating support; 32. an inner rotating support; 33. an elastomeric seal; 34. a compression member; 4. balloon inflation; 5. a guidewire inlet.
Detailed Description
The technical features of the technical solutions provided by the present invention are further clearly and completely described below with reference to the specific embodiments, and the scope of protection is not limited thereto.
The words "preferred", "more preferred", and the like, in the present invention refer to embodiments of the invention that may provide certain benefits, under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the invention.
In order to solve the technical problem, the invention provides an adjustable calculus removing balloon in a first aspect, which comprises a balloon 1, a catheter 2, a pushing mechanism 3 and a balloon filling opening 4; one end of the catheter 2 is coated with a balloon 1, and the other end is provided with a pushing mechanism 3; the balloon filling opening 4 is arranged between the balloon 1 and the pushing mechanism 3 and is used for injecting and discharging air or physiological saline.
In order to better realize the purpose of the invention, a balloon filling opening 4 is arranged between the balloon 1 and the pushing mechanism 3, the balloon filling opening 4 is relatively far away from one end of the balloon 1, and is closer to one end of the pushing mechanism 3, so that water or air can be conveniently injected, and the pushing mechanism 3 can be used for sealing to prevent water or air from leaking.
In a preferred or alternative embodiment, a water delivery channel 21 and an output channel 22 are provided in the conduit 2.
Further preferably, the water delivery channel 21 communicates the balloon 1 and the balloon filling opening 4.
It is further preferable that the water delivery passage 21 and the output passage 22 are concentrically arranged, and the inner diameter of the output passage 22 is smaller than that of the water delivery passage 21.
Generally, in order to avoid the compression injury to the affected part of the patient caused by too fast shrinkage of the balloon 1 during water pumping, the inner diameter of the output channel 22 should be as small as possible than that of the water delivery channel 21, so that the water in the balloon 1 slowly flows out.
Further preferably, the pushing mechanism 3 comprises an outer rotating support 31 and an inner rotating support 32 in threaded fit with the outer rotating support, and the tightness of the pushing mechanism 3 can be adjusted by rotating the outer rotating support 21.
The outer rotary support 31 is provided with internal threads, and the inner rotary support 32 is provided with external threads; the external rotation support 31 can move back and forth through thread matching, when the external rotation support 31 is screwed, the compression piece 34 moves towards the direction close to the elastic sealing piece 33 to extrude the elastic sealing piece 33, so that the elastic sealing piece is deformed to play a role in fastening and sealing, water or air in the balloon 1 cannot leak, and the stability of the calculus removal balloon is maintained; when the external rotation support 31 is unscrewed, the compression piece 34 loses the extrusion effect on the elastic sealing piece 33, so that water or air in the balloon 1 leaks out to a certain degree, when the balloon 1 reaches a required state, the external rotation support 31 can be screwed again to realize sealing, and finally adjustability is realized.
Further preferably, an elastic sealing element 33 is arranged in the inner rotating support 32, and a compression element 34 is arranged in the outer rotating support 31; the compression piece 34 is pressed on the elastic sealing piece 33; the elastic sealing element 33 and the compression element 34 are both circular ring structures and are respectively fixed on the inner rotating support 32 and the outer rotating support 31.
Further preferably, the elastic sealing member 33 is compressible rubber or silicone rubber.
Further preferably, the compression member 34 is a metal compression ring.
Still more preferably, the catheter 2 is further provided with a guide wire inlet 5.
More preferably, the material of the balloon 1 is a silicone rubber composite material.
More preferably, the balloon 1 is made of a silicone rubber composite material, and as an organic silicon rubber composite material suitable for medical balloons, the inflated shape is regular, the surface is smooth, and no damage is caused.
In some embodiments, the silicone rubber composite comprises, by weight, 40-60 parts of methyl vinyl silicone rubber, 100-120 parts of aromatic modified terpene resin, 20-40 parts of alkyl phenolic resin, 3-10 parts of tributyl citrate, 3-8 parts of diisobutyl tin dilaurate, 8-15 parts of calcium carbonate, 3-9 parts of chlorinated paraffin, 8-15 parts of calcium stearate, and 1-4 parts of dicumyl peroxide.
In a preferred or alternative embodiment, the silicone rubber composite is prepared as follows: the method comprises the steps of uniformly mixing raw methyl vinyl silicone rubber, aromatic modified terpene resin, alkyl phenolic resin, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin, calcium stearate and dicumyl peroxide in an open rubber mixing mill, then thinly passing for 8-10 times, rolling for 5 times, taking out a sheet, standing at room temperature for 12-24 hours, turning over once, vulcanizing and forming on a flat vulcanizing machine, and then carrying out secondary vulcanization in a blast oven to remove residual oxidant.
In a preferred or alternative embodiment, the aromatic modified terpene resin is an aromatic modified terpene resin having a TG glass transition temperature of less than 85 ℃; more preferably, the aromatic modified terpene resin is a styrene modified terpene resin having a TG glass transition temperature of less than 65 ℃.
The styrene modified terpene resin described herein has low color, little odor, good compatibility with most polyolefins, low melt viscosity, and wide application range, and is suitable for high temperature requirements.
In a preferred or alternative embodiment, as styrene modified terpene resins having a glass transition temperature of less than 65 ℃, there may be mentioned, but are not limited to: sylvares ZT105LT (TG: 59 ℃), Sylvares ZT115LT (TG: 85 ℃), Sylvares ZT5100 (TG: 45 ℃).
In a preferred or alternative embodiment, the mass ratio of the methyl vinyl silicone rubber, the styrene modified terpene resin and the alkyl phenol resin is 50: (100-120): (30-40); more preferably 50: (110-120): (30-35).
The alkylphenol-formaldehyde resin is a resin obtained by reacting phenol having an alkyl substituent on the benzene ring 1 with formaldehyde.
In a preferred or alternative embodiment, the alkyl phenolic resin is an alkyl phenolic resin with an acid value of 50-110.
In a preferred or alternative embodiment, the alkylphenol-formaldehyde resins having an acid number of 50 to 110 include, but are not limited to: TAMANOL 100S (acid number: 85-100), TAMANOL 200N (acid number: 50-110).
In the research, the preferable styrene modified terpene resin has better performance than terpene resin in the selection of the resin, and the styrene modified terpene resin not only can be well compatible with the rubber matrix, has softening effect on the rubber matrix, but also can improve the modulus of vulcanized rubber due to excellent mechanical properties of the styrene modified terpene resin; surprisingly, in further research, the mass ratio of the methyl vinyl silicone rubber, the styrene modified terpene resin and the alkyl phenolic resin is 50: (100-120): (30-40) the better the dimensional stability of the silicone rubber material, the inventor speculates that a small amount of vulcanization may occur in the styrene modified terpene resin, and the regularity of the vulcanization reaction process of the methyl vinyl silicone rubber is destroyed by the vulcanization, so that the orderly arrangement of the terpene resin to form crystals is avoided; on the other hand, the interpenetrating polymer network structure can be formed under the proportion in vulcanization, and the mechanical property of the interpenetrating polymer network structure is improved.
Further, among the choices of the styrene-modified terpene resin, the inventors found that the choice of the glass transition temperature of the styrene-modified terpene resin also has some influence on the dimensional stability of the silicone rubber material, and that the dimensional stability is the best when the glass transition temperature thereof is less than 65 ℃. The inventors believe that when the styrene-modified terpene resin dilutes the rubber matrix to some extent after addition, it wraps the vulcanizer in the early stage of vulcanization when the glass transition temperature is 65 ℃ or lower, and at this time, the fluidity of the resin is high, and the vulcanizing agent wrapped therein is therefore more likely to migrate, thus resulting in a higher crosslinking density than other resins during the mutual crosslinking, resulting in better elasticity of the silicone rubber material.
In the further research of the styrene modified terpene resin in the system, the rubber matrix vulcanizing agent is inevitably diluted to a certain extent, and the dilution can reduce the crosslinking density, so that the material cannot be quickly retracted after being deformed, and finally can cause permanent deformation, so that the rubber modified terpene resin is only suitable for one-time use or less-time use; after the formula is adjusted, the inventor adds a proper amount of alkyl phenolic resin, and the inventor finds that the size stability is good after a plurality of experiments, the inventor believes that when a small amount of alkyl phenolic resin exists in the formula, the resin is acidic, the acid value content is generally between 10 and 150, under the effect of obtaining better size stability, the acid value is preferably 50 to 110, and because the calcium carbonate generally purchased contains impurity metal elements, the calcium carbonate has a certain coordination effect with the resin, metal aggregates are easily formed with the metal impurities, the calcium carbonate has a certain stabilizing effect, the strengthening effect is achieved, the dispersivity of the calcium carbonate is beneficial, the intermolecular adhesion is stronger through the ionic effect, and in a system microscopic state, the pi accumulation of the two resins and the methyl vinyl silicone rubber long chain form a core-shell structure, it is easier to relieve stress in the form of slippage under stress.
The tributyl citrate, namely tributyl citrate, the chemical name of which is 3-hydroxy-3-carboxyl glutaric acid tributyl ester, is an ester compound and can be mutually dissolved with most organic solvents. The plasticizer is prepared by reacting citric acid with n-butyl alcohol, can be directly used as a plasticizer, and can be further processed into a plasticizer acetyl tributyl citrate with excellent performance, so that the plasticizer is a phthalate plasticizer with limited application range.
In a preferred or alternative embodiment, specific examples of the chlorinated paraffin include chlorinated paraffin 52, chlorinated paraffin 70, chlorinated paraffin 52, chlorinated paraffin 42; here, the chlorinated paraffin 70 is preferred, and is commercially available, and its purchase source is not limited at all.
The present invention is described in detail below by way of examples, and in addition, if not otherwise stated, the starting materials are commercially available, wherein calcium carbonate is JKLM-a1 product of a new material from hokkansi mine.
Examples
Example 1
As shown in fig. 1 and 2, embodiment 1 of the present invention provides an adjustable calculus removal balloon, which includes a balloon 1, a catheter 2, a pushing mechanism 3, and a balloon filling opening 4; one end of the catheter 2 is coated with a balloon 1, and the other end is provided with a pushing mechanism 3; the balloon filling opening 4 is arranged between the balloon 1 and the pushing mechanism 3 and is used for injecting and discharging air or normal saline; this sacculus is full of the position of mouthful 4 and is kept away from the one end of sacculus 1 relatively, and is closer the one end of push mechanism 3, and first one makes things convenient for injected water or air, and second one is usable push mechanism to play sealed effect, prevents leaking of water or air.
A water delivery channel 21 and an output channel 22 are arranged in the catheter 2, the water delivery channel 21 is communicated with the balloon 1 and the balloon filling opening 4, the water delivery channel 21 and the output channel 22 are concentrically arranged, and the inner diameter of the output channel 22 is smaller than that of the water delivery channel 21.
The pushing mechanism 3 comprises an outer rotating support 31 and an inner rotating support 32 in threaded fit with the outer rotating support 31, and the tightness of the pushing mechanism 3 can be adjusted by rotating the outer rotating support 31; an elastic sealing element 33 is arranged in the inner rotating support 32, and a compression element 34 is arranged in the outer rotating support 31; the compression piece 34 is pressed on the elastic sealing piece 33; the elastic sealing element 33 and the compression element 34 are both circular structures and are respectively fixed on the inner rotating support 32 and the outer rotating support 31; the elastic sealing element 33 is silica gel; the compression member 34 is a metal compression ring;
the outer rotary support 31 is provided with internal threads, and the inner rotary support 32 is provided with external threads; the external rotation support 31 can move back and forth through thread matching, when the external rotation support 31 is screwed, the compression piece 34 moves towards the direction close to the elastic sealing piece 33 to extrude the elastic sealing piece 33, so that the elastic sealing piece is deformed to play a role in fastening and sealing, water or air in the balloon 1 cannot leak, and the stability of the calculus removal balloon is maintained; when the external rotation support 31 is unscrewed, the compression piece 34 loses the extrusion effect on the elastic sealing piece 33, so that water or air in the balloon 1 leaks out to a certain degree, when the balloon 1 reaches a required state, the external rotation support 31 can be screwed again to realize sealing, and finally adjustability is realized.
The catheter 2 is also provided with a guide wire inlet 5; the balloon 1 is made of silicon rubber.
When the adjustable balloon is used, the adjustable balloon can be pushed into a bile duct through a clamping duct channel of a choledochoscope, then a guide wire is placed through a guide wire inlet 5, the guide wire is pushed under the observation of the choledochoscope, the balloon is introduced into a narrow part, the outer rotating support 31 is screwed, the normal saline is injected from the balloon filling opening 4, at the moment, the balloon 1 starts to expand, and the balloon is expanded to a proper state through the screwing or unscrewing of the outer rotating support 31 to start a subsequent operation.
Example 2
Embodiment 2 of the invention provides an adjustable calculus removing balloon, which is the same as embodiment 1 in structure, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 112 parts of Sylvares ZT105LT (TG: 59 ℃), 33 parts of alkylphenol formaldehyde resin TAMANOL 100S (acid value: 85-100), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, Sylvares ZT105LT, alkyl phenolic resin TAMANOL 100S, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open type rubber mixing mill, then the mixture is passed through a thin mill for 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then secondary vulcanization is carried out in a blast oven to remove residual oxidant.
Example 3
Embodiment 3 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 112 parts of Sylvares ZT105LT (TG: 59 ℃), 33 parts of alkylphenol formaldehyde resin TAMANOL 200N (acid value: 50-110), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, Sylvares ZT105LT, alkyl phenolic resin TAMANOL 200N, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open type rubber mixing mill, then the mixture is passed through a thin mill for 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then secondary vulcanization is carried out in a blast oven to remove residual oxidant.
Example 4
Embodiment 4 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 112 parts of Sylvares ZT105LT (TG: 59 ℃), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the preparation method comprises the following steps of uniformly mixing raw methyl vinyl silicone rubber, Sylvares ZT105LT, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide in an open rubber mixing mill, then carrying out thin passing for 10 times, rolling for 5 times, taking out a sheet, standing at room temperature for 24 hours, turning over for one time, carrying out vulcanization molding on a flat vulcanizing machine, and then carrying out secondary vulcanization in a forced air oven to remove residual oxidant.
Example 5
Embodiment 5 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 132 parts of Sylvares ZT105LT (TG: 59 ℃), 13 parts of alkylphenol formaldehyde resin TAMANOL 100S (acid value: 85-100), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, Sylvares ZT105LT, alkyl phenolic resin TAMANOL 100S, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open type rubber mixing mill, then the mixture is passed through a thin mill for 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then secondary vulcanization is carried out in a blast oven to remove residual oxidant.
Example 6
Embodiment 6 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 82 parts of Sylvares ZT105LT (TG: 59 ℃), 63 parts of alkylphenol formaldehyde resin TAMANOL 100S (acid value: 85-100), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, Sylvares ZT105LT, alkyl phenolic resin TAMANOL 100S, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open type rubber mixing mill, then the mixture is passed through a thin mill for 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then secondary vulcanization is carried out in a blast oven to remove residual oxidant.
Example 7
Embodiment 7 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 112 parts of Sylvares ZT115LT (TG: 85 ℃), 33 parts of alkylphenol formaldehyde resin TAMANOL 100S (acid value: 85-100), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, Sylvares ZT115LT, alkyl phenolic resin TAMANOL 100S, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open type rubber mixing mill, then the mixture is passed through a thin mill for 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then secondary vulcanization is carried out in a blast oven to remove residual oxidant.
Example 8
Embodiment 8 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, SYLVARES TR 5147112 parts of terpene resin, 33 parts of alkylphenol formaldehyde resin TAMANOL 100S (acid value: 85-100), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, terpene resin SYLVARES TR5147, alkyl phenolic resin TAMANOL 100S, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open rubber mixing mill, then the mixture is passed through 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then subjected to secondary vulcanization in a blast oven to remove residual oxidizing agent.
Example 9
Embodiment 9 of the present invention provides an adjustable calculus removing balloon, which has the same structure as that in embodiment 1, except that the balloon 1 is made of a silicone rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 112 parts of Sylvares ZT105LT (TG: 59 ℃), 33 parts of American SIGROUP phenolic resin FRJ-551 (acid value: 15-35), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the preparation method comprises the following steps of uniformly mixing raw methyl vinyl silicone rubber, Sylvares ZT105LT, American SIGROUP phenolic resin FRJ-551, tributyl citrate, diisobutyltin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide in an open type rubber mixing mill, then carrying out thin passing for 10 times, rolling for 5 times, taking out a sheet, standing at room temperature for 24 hours, turning over once, vulcanizing and forming on a flat vulcanizing machine, and then carrying out secondary vulcanization in a blast oven to remove residual oxidant.
Example 10
Embodiment 10 of the invention provides an adjustable calculus removing balloon, which has the same structure as that of embodiment 1, and is different in that the balloon 1 is made of a silicon rubber composite material.
The silicone rubber composite material comprises, by weight, 50 parts of methyl vinyl silicone rubber, 112 parts of Sylvares ZT105LT (TG: 59 ℃), 33 parts of alkylphenol formaldehyde resin TAMANOL 100S (acid value: 85-100), 7 parts of tributyl citrate, 5 parts of diisobutyl tin dilaurate, 12 parts of calcium carbonate, 7 parts of chlorinated paraffin 70, 13 parts of calcium stearate and 2 parts of dicumyl peroxide.
The preparation method of the silicone rubber composite material is as follows: the methyl vinyl silicone rubber raw rubber, Sylvares ZT105LT, alkyl phenolic resin TAMANOL 100S, tributyl citrate, diisobutyl tin dilaurate, calcium carbonate, chlorinated paraffin 70, calcium stearate and dicumyl peroxide are mixed uniformly in an open type rubber mixing mill, then the mixture is passed through a thin mill for 10 times, rolled for 5 times, taken out, placed at room temperature for 24 hours, turned over once, vulcanized and formed on a flat vulcanizing machine, and then secondary vulcanization is carried out in a blast oven to remove residual oxidant.
Evaluation of Performance
1. Balloon shape stability test
The test method comprises the following steps: filling physiological saline into the adjustable calculus removing balloon in the embodiment 1-10 until the balloon is full and kept for 10min, and recording the diameter of the balloon at the moment as L1; injecting 0.5ml of normal saline into the balloon, keeping the balloon for 10min, and recording the diameter of the balloon at the moment as L2; injecting 1.5ml of normal saline into the balloon, keeping the normal saline for 10min, and recording the diameter of the balloon at the moment as L3; injecting 3ml of physiological saline into the balloon, keeping the balloon for 10min, and recording the diameter of the balloon at the moment as L4; calculating L from L1, L2, L3, L42-1＝(L2-L1)/L1*100，L3-1＝(L3-L1)/L1*100、L4-1Balloon shape stability was judged as (L4-L1)/L1 x 100.
TABLE 1
Examples L2-1 L3-1 L4-1
Example 1 1.8 2.5 4.2
Example 2 0.6 1.1 2.4
Example 3 0.5 1.3 2.6
Example 4 0.6 1.9 3.5
Example 5 1 2.4 4.4
Example 6 1.1 2.3 4.6
Example 7 0.7 1.9 3.2
Example 8 0.9 2.3 4.3
Example 9 0.8 2.1 4.2
Example 10 0.7 1.9 3.6
2. Balloon recovery dimensional stability test
The test method comprises the following steps: filling the adjustable calculus removing balloon in the embodiment 1-10 with physiological saline until the balloon is fully filled for 10min, recording the diameter of the balloon at the moment as L0, pumping out the physiological saline, refilling with the physiological saline and pumping out, repeating the operation for 10 times, measuring the diameter of the balloon after the balloon is filled with the physiological saline for 10 times until the balloon is fully filled for 10min, and recording the diameter of the balloon at the moment as L10; repeating the steps for 50 times, measuring the balloon diameter after the physiological saline is filled for 50 times until the physiological saline is fully filled and the balloon diameter is kept for 10min, and recording the balloon diameter at the moment as L50; after repeating the steps for 100 times, measuring the diameter of the balloon after the balloon is filled with physiological saline for 100 times till the balloon is fully filled and kept for 10min, and marking the diameter of the balloon at the moment as L100; calculating L from L0, L10, L50, L10010＝∣L10-L0∣/L0*100，L50＝∣L50-L0∣/L0*100、L100And | L100-L0 | L0 × 100 determines the recovered dimensional stability of the balloon.
TABLE 2
Figure BDA0002597645090000121
Figure BDA0002597645090000131

Claims (10)

1. An adjustable lithotomy balloon comprises a balloon, a catheter, a pushing mechanism and a balloon filling opening; the device is characterized in that one end of the catheter is coated with a saccule, and the other end of the catheter is provided with a pushing mechanism; the balloon filling opening is arranged between the balloon and the pushing mechanism and used for injecting and discharging air or normal saline.
2. The adjustable lithotomy balloon of claim 1, wherein a water delivery channel and an output channel are provided in said catheter.
3. The adjustable lithotomy balloon of claim 2, wherein said water delivery channel communicates between the balloon and the balloon inflation port.
4. The adjustable lithotomy balloon of claim 3, wherein said water delivery channel and said output channel are concentrically arranged, and wherein the output channel has a smaller inner diameter than the water delivery channel.
5. The adjustable lithotomy balloon of any one of claims 1-4, wherein the pushing mechanism comprises an outer rotating support and an inner rotating support in threaded fit with the outer rotating support, and the tightness of the pushing mechanism can be adjusted by rotating the outer rotating support.
6. The adjustable lithotomy balloon of claim 5, wherein an elastic sealing member is arranged in said inner rotary support, and a compression member is arranged in said outer rotary support; the compression piece is pressed on the elastic sealing piece.
7. The adjustable lithotomy balloon of claim 6, wherein said elastic seal is a compressible rubber or silicone.
8. The adjustable lithotomy balloon of claim 7, wherein said compression member is a metal compression ring.
9. The adjustable lithotomy balloon of any of claims 1-8, wherein a guide wire inlet is further provided on the catheter.
10. The adjustable lithotomy balloon of claim 9, wherein said balloon is made of a silicone rubber composite material.
CN202010714351.4A 2020-07-21 2020-07-21 Adjustable stone removal sacculus Withdrawn CN111956299A (en)

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