CN116687495B - Implanted saccule - Google Patents

Implanted saccule Download PDF

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Publication number
CN116687495B
CN116687495B CN202310906022.3A CN202310906022A CN116687495B CN 116687495 B CN116687495 B CN 116687495B CN 202310906022 A CN202310906022 A CN 202310906022A CN 116687495 B CN116687495 B CN 116687495B
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CN
China
Prior art keywords
balloon
cavity
liquid
implantable
implanted
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Active
Application number
CN202310906022.3A
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Chinese (zh)
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CN116687495A (en
Inventor
李虎
梁坤
韩梁
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Shanghai Hope Medical Devices Co ltd
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Shanghai Hope Medical Devices Co ltd
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Priority to CN202310906022.3A priority Critical patent/CN116687495B/en
Publication of CN116687495A publication Critical patent/CN116687495A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12036Type of occlusion partial occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/1204Type of occlusion temporary occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Abstract

An implantable balloon, comprising: the implanted balloon comprises a balloon part, a supporting part and a water inlet cavity, wherein the balloon part is connected end to end by a plurality of balloons, the supporting part is annular and is arranged at the joint of the balloons to form a central cavity channel of the implanted balloon, the water inlet cavity is arranged at one end of the implanted balloon and is used for allowing liquid to pass through the liquid entering the balloon part, and a one-way valve is further arranged in the water inlet cavity, so that the liquid can only advance towards the direction entering the balloon part; the conveying catheter comprises a guide wire cavity and a water supply cavity, the guide wire cavity is used for passing through a guide wire, and the water supply cavity is connected with the water inlet cavity and used for filling the balloon part with liquid; the connecting part is arranged between the implanted saccule and the conveying catheter and is used for connecting the implanted saccule and the conveying catheter, and the connecting part is made of water-soluble materials.

Description

Implanted saccule
Technical Field
The invention relates to the field of medical instruments, in particular to an implantable balloon.
Background
The heart failure patients in China are about 450 ten thousand people, wherein the death rate of the acute heart failure reaches 10%, the incidence rate of the heart failure in China rises year by year, wherein the number of AHF patients accounts for about 25%, the acute incidence rate of AHF is bad, the prognosis is bad, the recurrence rate in half a year is about 50%, and most of the acute heart failure patients in clinic belong to Acute Decompensated Heart Failure (ADHF). In the united states, the hospitalization for acute decompensated heart failure is over one million.
The symptoms of acute left heart failure, such as high pulmonary circulation pressure and fluid retention, are clinically realized by accelerating the kidney to separate out electrolyte and moisture in blood so as to reduce blood pressure, thereby reducing other symptoms such as pulmonary circulation pressure; the resistance of diuretics is a common phenomenon in heart failure treatment, and is the congestion of the kidney, and the blood flow of the kidney is not enough to the inferior vena cava, so that the drainage of the kidney is very small, and the blood pressure cannot be reduced. How to improve diuretic resistance is a treatment focus for patients with heart failure fluid retention.
Clinically, blood pressure can be reduced by regulating blood flowing into the kidney by a blood regulating device, for example, the regulating device is placed in the inferior vena cava and positioned at the tail of the inlet of the kidney vein, and blood flow entering the kidney is regulated to reduce blood pressure. Admission to a hospital, caused by acute heart failure, is generally in an unstable period of one month, and needs to be continuously observed during the period, and the blood flow size is regulated according to the situation. However, the current similar products are often inconvenient to adjust, or the diameters of the vascular stents cannot be adjusted in a reciprocating manner, so that inconvenience is caused to the use of the products, and the treatment is affected.
Disclosure of Invention
The invention aims to overcome the defects and provide an implanted balloon.
The technical scheme adopted by the invention is as follows:
an implantable balloon, comprising:
the implanted balloon comprises a balloon part, a supporting part and a water inlet cavity, wherein the balloon part is connected end to end by a plurality of balloons, the supporting part is annular and is arranged at the joint of the balloons to form a central cavity channel of the implanted balloon, the water inlet cavity is arranged at one end of the implanted balloon and is used for allowing liquid to pass through the liquid entering the balloon part, and a one-way valve is further arranged in the water inlet cavity, so that the liquid can only advance towards the direction entering the balloon part;
the conveying catheter comprises a guide wire cavity and a water supply cavity, the guide wire cavity is used for passing through a guide wire, and the water supply cavity is connected with the water inlet cavity and used for filling the balloon part with liquid;
the connecting part is arranged between the implanted saccule and the conveying catheter and is used for connecting the implanted saccule and the conveying catheter, the connecting part is made of water-soluble materials, and after meeting water, the connecting part is gradually dissolved to separate the implanted saccule from the conveying catheter;
in clinical use, after the implanted saccule is conveyed into a blood vessel and filled with liquid, the connecting part is gradually dissolved under the action of blood and then is withdrawn from the conveying catheter, the implanted saccule is left in the blood vessel, a doctor selects any time point to apply pressure to a plurality of saccules of the saccule part by using one saccule catheter according to clinical needs, at the moment, the liquid in the pressurized saccule flows into the unpressurized saccule, and under the action of more liquid, the unpressurized saccule expands towards the direction of the central cavity, so that the blood flow in the central cavity is changed.
Preferably, an exchange channel is provided between the plurality of balloons of the balloon portion, so that liquid can flow between the balloons through the exchange channel.
Preferably, the exchange cavity is in two states of a closed state and a communicating state, and the exchange cavity is converted into the communicating state from the closed state after being stressed.
Preferably, the exchange channel is switched between a closed state and a connected state under the elastic action of the support part.
Preferably, the balloon portion on the side closer to the central lumen is composed of a compliant material and the balloon portion on the side farther from the central lumen is composed of a non-compliant material.
Preferably, when the balloon portion is inflated by the liquid, one side of the compliant material expands toward the central lumen, while the non-compliant material side does not deform.
Preferably, the material of the supporting portion is at least one of stainless steel, nickel-titanium alloy and cobalt-chromium alloy.
Preferably, the two ends of the implanted balloon are provided with developing rings.
Preferably, the liquid filled into the implantable balloon is developable.
Preferably, the guide wire cavity and the water supply cavity are concentrically distributed or vertically parallel.
Preferably, the outer layer tube bodies at two ends of the implanted saccule are of metal braiding structures so as to prevent the tube bodies at two ends from sinking.
Preferably, the metal braiding structure is encapsulated by a polymeric material.
The invention has the beneficial effects that:
1. the diameter of the implanted saccule can be adjusted only by using saccule catheter intervention, the operation is simple and convenient, and the wound is small;
2. the inner diameter of the implanted saccule can be repeatedly adjusted according to the requirements of doctors, and can be well adapted to clinical requirements.
Drawings
FIG. 1 is a schematic view of an implantable balloon structure according to the present invention;
FIG. 2 is a schematic view of the structure of an implantable balloon according to the present invention;
FIG. 3 is a schematic view of a delivery catheter according to the present invention;
FIG. 4 is a schematic illustration of the process of changing the inner diameter of an implantable balloon according to the present invention;
FIG. 5 is a schematic illustration of the blood flow state of an implantable balloon of the present invention after an inner diameter change;
FIG. 6 is a schematic illustration of the application of pressure to an implantable balloon by a profiled balloon catheter of the present invention;
FIG. 7 is another schematic representation of the blood flow state after the inner diameter of the implantable balloon of the present invention has been changed.
Description of the embodiments
Embodiments of the present invention are described in further detail below with reference to the accompanying drawings and examples. The following examples are illustrative of the invention but are not intended to limit the scope of the invention.
An implantable balloon, comprising:
the implantable balloon 100, the implantable balloon 100 includes a balloon portion 110, a support portion 120 and a water inlet cavity 130, the balloon portion 110 is connected end to end by a plurality of balloons 111, the support portion 120 is annular, and is disposed at the connection of the balloons 111 to form a central cavity of the implantable balloon 100, the central cavity is used for passing through blood flow, the support portion 120 also provides a radial force, so that the implantable balloon 100 is limited in a blood vessel, displacement of the implantable balloon 100 is prevented, the water inlet cavity 130 is disposed at one end of the implantable balloon 100, and is used for passing through liquid entering the balloon portion 110, and a one-way valve 131 is disposed in the water inlet cavity 130, so that the liquid can only advance towards the direction entering the balloon portion 110.
The delivery catheter 200, the delivery catheter includes a guide wire cavity 210 and a water supply cavity 220, the guide wire cavity 210 is used for passing through a guide wire, the water supply cavity 220 is connected with the water inlet cavity 130, and is used for filling the balloon portion 110 with liquid, and the guide wire is inserted into the guide wire cavity 210 during the delivery process, so that sufficient hardness can be provided for the delivery system, and smooth delivery is ensured.
The connecting part 300 is arranged between the implanted balloon 100 and the delivery catheter 200 and is used for connecting the implanted balloon 100 and the delivery catheter 200, the connecting part 300 is made of a water-soluble material, and after encountering water, the connecting part 300 is gradually dissolved to separate the implanted balloon 100 and the delivery catheter 200. When delivery catheter 200 is used to deliver implantable balloon 100 to a desired location in a blood vessel, it is necessary to separate implantable balloon 100, so that the material of connection 300 is configured to be blood-soluble, so that delivery catheter 200 can be withdrawn leaving implantable balloon 100 in place after delivery catheter 100 is released.
The product of the present invention is first delivered to the desired location in the blood vessel, and then a developable fluid, such as contrast medium, is injected from the water supply lumen 220 of the delivery catheter 200, the connection 300 is gradually dissolved during the injection of the fluid, and after the connection 300 is dissolved to a certain extent, the delivery catheter is withdrawn, and optimally, the connection 300 is dissolved to a time of 60 seconds for separating the implantable balloon 100 from the delivery catheter 200. After the delivery catheter 200 is removed from the blood vessel, the implantable balloon 100 is attached to the blood vessel under the action of the supporting portion 120, at this time, a balloon catheter is used to apply pressure to a portion of the balloons 111 from the center of the implantable balloon 100, at this time, under the action of the pressure, the liquid in the pressurized balloons 111 flows into the non-pressurized balloons 111, for example, the balloon portions 110 share two balloons, and one of the balloons is pressed by the balloon catheter, so that the liquid in the one balloon flows into the other balloon, and when the liquid in the other balloon is too much, the other balloon expands in the direction of the central cavity to change the diameter of the central cavity, thereby changing the blood flow in the central cavity, as shown in fig. 4 and 5, and if the number of the balloons in the balloon portions is greater than three, the abnormal balloon catheter can also be used to simultaneously press a plurality of balloons, as shown in fig. 6 and 7. Wherein the balloon catheter used in fig. 4, 5 is a single balloon catheter conventionally used; the balloon catheter used in fig. 6 and 7 is a profiled balloon catheter having a plurality of balloons distributed over the catheter.
The balloon part is composed of a compliant material and a non-compliant material, and the balloon part near one side of the central cavity is composed of a compliant material, such as polyvinyl chloride; the balloon portion on the side remote from the central lumen is composed of a non-compliant material such as nylon, polyethylene terephthalate. When the balloon portion is inflated by the liquid, one side of the compliant material expands toward the central lumen, while one side of the non-compliant material does not deform, thus protecting the vessel when the balloon portion is inflated.
In actual clinical cases, the implantable balloon is firstly delivered to the inferior vena cava at the tail of the inlet of the renal vein by using a delivery system, the admission caused by acute heart failure generally has an unstable period, and needs to be observed continuously during the period, so the implantable balloon needs to be left in the body, the implantable balloon is expanded by using a balloon catheter according to clinical conditions, the inner diameter of the implantable balloon is changed to adjust the blood flow, so that the blood entering the kidney is adjusted to reduce the blood pressure, in one embodiment, the balloon parts have three balloons in total, if the middle balloon is required to be expanded, the balloon at one end needs to be expanded, when the expansion amplitude of the middle balloon does not reach the expected value, the balloon at the other end can be expanded again, the expansion peak value of the middle balloon can be further increased, after the treatment effect reaches the expected value, the balloon parts can be fully covered by using a longer balloon catheter, and then all the balloon parts can be simultaneously applied with pressure through the balloon catheter, so that the diameters of the implanted balloon parts can be uniformly distributed to the original diameters.
Exchange channels are provided between the plurality of balloons 111 of the balloon portion 110 so that liquid can flow between the balloons through the exchange channels. The exchange cavity is in a closed state and a communicating state, in a natural state, the exchange cavity is in a closed state, at the moment, liquid cannot completely enter the balloon portion 110, liquid cannot be exchanged between the balloons, when external force is applied to the cavity, such as when the balloon portion is filled with liquid, or when the balloon catheter is used for pressing the filled balloon, the exchange cavity is opened to form a communicating state for the mutual circulation of the liquid, and after the external force is removed, the exchange cavity is closed.
The sealing and the communication of the exchange cavity are carried out under the action of the elastic force of the supporting part, in a natural state, the supporting part can press the exchange cavity under the action of the radial force of the supporting part, so that the exchange cavity is sealed, when water is supplied to the balloon, the supporting part can shrink towards the axis under the pressure of the water, the sealed exchange cavity is opened, after the balloon is filled, the water pressure is removed, and the supporting part can rebound, so that the exchange cavity is sealed again. If the inner diameter of the implanted balloon is required to be changed, only one balloon catheter is required to apply pressure to one balloon filled with liquid, at the moment, the liquid in the balloon can apply water pressure to the next exchange cavity, the exchange cavity is opened to enable the liquid to flow into the other balloon, the other balloon can expand towards the axle center, and the diameter of the implanted balloon is changed. In order to achieve the closing and opening of the exchange channels, the support portion needs to have sufficient elasticity, preferably, the support portion is made of nickel-titanium alloy, and the exchange channels can be quickly restored to the closed state from the communicating state after the water pressure is removed because the nickel-titanium alloy has super elasticity which is far greater than that of common materials. The material of the support part can also be stainless steel or cobalt-chromium alloy.
The two ends of the implanted balloon are also provided with developing rings 140. In the operation process, the position of the implantable balloon is required to be observed through X-rays, so that the implantable balloon can be placed at an expected position, and therefore, the two ends of the implantable balloon are provided with the developing rings 140, and the accuracy of the release position of the implantable balloon is improved.
However, the developing rings 140 at both ends only help to observe the end positions of the implanted balloon, the size of the inner cavity of the implanted balloon cannot be observed after the balloon portion is filled, and the change condition of the diameter of the inner cavity cannot be observed, so that the liquid filled into the implanted balloon needs to have developing property, and a doctor can observe the change of the inner diameter of the implanted balloon well through X rays with the help of developing liquid.
The guide wire cavity and the water supply cavity are concentrically distributed or vertically and parallelly distributed. Preferably, the two channels are distributed in parallel up and down, so that the processing and manufacturing can be better.
The outer layer tubular bodies at the two ends of the implanted saccule are woven by metal to provide powerful support and prevent the tubular bodies at the two ends from sinking under the impact of blood flow, if sinking occurs, the blood flow channel of the implanted saccule is reduced, and the stent is possibly narrowed over time. In order to improve biocompatibility, the metal woven structure is wrapped by a high polymer material.
In another embodiment, two supporting parts may be disposed at two ends of the implantable balloon, and the supporting parts may naturally close the water inlet cavity 130, so that when the delivery catheter 200 is separated from the implantable balloon 100, the supporting parts at two ends of the implantable balloon may assist the one-way valve 131 to prevent the liquid from flowing out of the balloon. In addition, the supporting parts at the two ends can replace the braiding structures at the two ends, so that the aim of preventing the tube bodies at the two ends from sinking in is fulfilled.
The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. The invention is not limited to the embodiments described above, i.e. it is not meant that the invention has to be carried out in dependence on the embodiments described above. It should be apparent to those skilled in the art that any modification of the present invention, equivalent substitution of selected raw materials, addition of auxiliary components, selection of specific modes, etc. fall within the scope of the present invention and the scope of disclosure.

Claims (10)

1. An implantable balloon, comprising:
the implanted balloon comprises a balloon part, a supporting part and a water inlet cavity, wherein the balloon part is connected end to end by a plurality of balloons, the supporting part is annular and is arranged at the joint of the balloons to form a central cavity channel of the implanted balloon, the water inlet cavity is arranged at one end of the implanted balloon and is used for allowing liquid to pass through the liquid entering the balloon part, and a one-way valve is further arranged in the water inlet cavity, so that the liquid can only advance towards the direction entering the balloon part;
the conveying catheter comprises a guide wire cavity and a water supply cavity, the guide wire cavity is used for passing through a guide wire, and the water supply cavity is connected with the water inlet cavity and used for filling the balloon part with liquid;
the connecting part is arranged between the implanted saccule and the conveying catheter and is used for connecting the implanted saccule and the conveying catheter, the connecting part is made of water-soluble materials, and after meeting water, the connecting part is gradually dissolved to separate the implanted saccule from the conveying catheter;
exchange channels are arranged among the plurality of balloons of the balloon part, so that liquid can flow between the balloons through the exchange channels; the exchange cavity is provided with a closed state and a communicated state, and is converted into the communicated state from the closed state after being stressed;
in clinical use, after the implanted balloon is conveyed into a blood vessel and filled with liquid, the connecting part is gradually dissolved under the action of blood and then withdrawn from the conveying catheter, the implanted balloon is left in the blood vessel, a doctor selects any time point to apply pressure to a plurality of balloons of the balloon part by using one balloon catheter according to clinical needs, at the moment, the liquid in the pressurized balloon flows into the unpressurized balloon, under the action of more liquid, the unpressurized balloon expands towards the direction of the central cavity, so that the blood flow in the central cavity is changed, when the blood flow needs to be restored, the pressure is applied to the expanded balloon by using one balloon catheter, and the liquid in the expanded balloon is reduced under the action of the pressure, so that the central cavity is restored to the original diameter.
2. An implantable balloon according to claim 1 wherein the exchange lumen is switched between a closed state and an open state under the elastic action of the support.
3. An implantable balloon according to claim 1 wherein the balloon portion on the side closer to the central lumen is comprised of a compliant material and the balloon portion on the side farther from the central lumen is comprised of a non-compliant material.
4. An implantable balloon according to claim 3 wherein when the balloon portion is inflated by a liquid, one side of the compliant material expands toward the central lumen and one side of the non-compliant material does not deform.
5. The implantable balloon according to claim 2, wherein the support is at least one of stainless steel, nitinol and cobalt chrome.
6. An implantable balloon according to claim 1, wherein the implantable balloon is provided with a developing ring at both ends.
7. An implantable balloon according to claim 1 wherein the liquid filling the implantable balloon is developable.
8. An implantable balloon according to claim 1 wherein the guidewire lumen and the water supply lumen are concentrically distributed or vertically parallel.
9. An implantable balloon according to claim 1 wherein the outer tubular bodies at both ends of the implantable balloon are of a metal braid structure to prevent the tubular bodies at both ends from sagging.
10. An implantable balloon according to claim 9 wherein the metallic woven structure is encapsulated by a polymeric material.
CN202310906022.3A 2023-07-24 2023-07-24 Implanted saccule Active CN116687495B (en)

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CN202310906022.3A CN116687495B (en) 2023-07-24 2023-07-24 Implanted saccule

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CN116687495B true CN116687495B (en) 2023-11-03

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CN111529899A (en) * 2020-04-23 2020-08-14 深圳市先健心康医疗电子有限公司 Expandable balloon
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Publication number Priority date Publication date Assignee Title
JP2019050861A (en) * 2017-09-12 2019-04-04 信越ポリマー株式会社 Baloon catheter, and manufacturing method thereof
CN113260405A (en) * 2018-11-08 2021-08-13 奥斯蒂尔公司 Dual balloon catheter and method of use
CN211245115U (en) * 2019-06-18 2020-08-14 昆明医科大学第二附属医院 Interventional therapy balloon dilatation catheter
CN111369858A (en) * 2020-03-03 2020-07-03 恩微通科技(深圳)有限公司 Method for simulating retraction of brain tissue
CN111529899A (en) * 2020-04-23 2020-08-14 深圳市先健心康医疗电子有限公司 Expandable balloon
CN111772876A (en) * 2020-06-29 2020-10-16 科凯(南通)生命科学有限公司 Expansion saccule for sac type string valve
CN216536498U (en) * 2020-12-16 2022-05-17 上海纽脉医疗科技有限公司 Balloon dilatation catheter
WO2022174136A1 (en) * 2021-02-15 2022-08-18 Ccj Medical Devices Llc Toroid balloon for hemorrhage control

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