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CN119055310A - Rapid hemostatic balloon and system - Google Patents

Rapid hemostatic balloon and system Download PDF

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Publication number
CN119055310A
CN119055310A CN202411391675.3A CN202411391675A CN119055310A CN 119055310 A CN119055310 A CN 119055310A CN 202411391675 A CN202411391675 A CN 202411391675A CN 119055310 A CN119055310 A CN 119055310A
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CN
China
Prior art keywords
balloon
filling
target
hemostatic
inflation
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.)
Pending
Application number
CN202411391675.3A
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Chinese (zh)
Inventor
李喜莲
董洁仪
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Obstetrics and Gynecology Hospital of Fudan University
Original Assignee
Obstetrics and Gynecology Hospital of Fudan University
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Publication date
Application filed by Obstetrics and Gynecology Hospital of Fudan University filed Critical Obstetrics and Gynecology Hospital of Fudan University
Priority to CN202411391675.3A priority Critical patent/CN119055310A/en
Publication of CN119055310A publication Critical patent/CN119055310A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1025Connections between catheter tubes and inflation tubes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Pulmonology (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Reproductive Health (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明公开了一种快速止血球囊及系统,涉及医疗电子技术领域。所述快速止血球囊包括导管组件、球囊组件和充注分配组件;球囊组件包括多个球囊,多个球囊的囊腔相互独立;导管组件包括多个球囊管道,球囊管道与球囊一一对应设置;充注分配组件设置在充注装置与各球囊管道充注口之间,被配置为:根据接收到的球囊充注指令确定需要充注的目标球囊,在与目标球囊对应的球囊管道充注口对接后形成输注通路以向所述目标球囊充注流体使其膨胀;以及在流体充注完成后解除前述对接,目标球囊的充注口控制阀恢复关闭状态。本发明减少了人工操作,节省了时间,提高了球囊输注效率。

The present invention discloses a rapid hemostatic balloon and system, and relates to the field of medical electronic technology. The rapid hemostatic balloon includes a catheter assembly, a balloon assembly, and a filling distribution assembly; the balloon assembly includes a plurality of balloons, and the cavities of the plurality of balloons are independent of each other; the catheter assembly includes a plurality of balloon pipes, and the balloon pipes are arranged one by one with the balloons; the filling distribution assembly is arranged between the filling device and the filling ports of each balloon pipe, and is configured to: determine the target balloon to be filled according to the received balloon filling instruction, form an infusion passage after docking with the filling port of the balloon pipe corresponding to the target balloon to fill the target balloon with fluid to expand it; and release the aforementioned docking after the fluid filling is completed, and the filling port control valve of the target balloon returns to the closed state. The present invention reduces manual operation, saves time, and improves the efficiency of balloon infusion.

Description

Rapid hemostatic capsule and system
Technical Field
The invention relates to the technical field of medical electronics, in particular to a rapid hemostatic bag and a rapid hemostatic system.
Background
The hemostatic method has the advantages that the hemostatic effect is definite, but the hemostatic method is difficult to fill, the pressure on the inner wall of the body cavity is uneven, dead cavities are easy to form, and the hemostatic failure is caused, and in addition, the surface of some filling materials is rough, the smoothness is poor, and the pain of patients can be increased. Accordingly, the prior art proposes various balloon catheters for hemostasis of the natural lumen tract of the human body. Taking uterine cavity as an example, the hemostatic balloon is often used for postpartum hemostatic treatment, after the non-filled hemostatic balloon is pushed into the lower section of the uterine cavity, liquid is filled into the hemostatic balloon to expand the hemostatic balloon, the hemostatic balloon generates hydrostatic pressure from the uterine cavity to the outside of the uterine cavity, the hydrostatic pressure is larger than uterine arterial pressure, the balloon after water injection directly acts on the lower middle end of the uterus, namely the uterine artery inlet, the blood flow flowing into the uterus can be effectively reduced, the operation of the hemostatic treatment is simpler, the time consumption is less, the hemostatic effect can be rapidly exerted, and the balloon is easy to take out after the liquid is discharged after operation. Further, considering the problem of balloon slipping when the filling balloon of the uterine cavity is used for hemostasis, especially for patients with bleeding after the caesarean section after the delivery and the opening of the uterine opening are large, the hemostatic balloon is easy to slip into the vagina after filling water due to the problems of relaxation of the uterine opening, laceration of the uterine neck and the like, and the hemostatic balloon cannot be correctly remained in the uterine cavity, so that the hemostatic effect is poor, and the prior art also provides a technical scheme of the hemostatic balloon slipping prevention structure. for example, chinese patent ZL202010227168.1 discloses a pressure accurate regulation type uterine bleeding stopping bag device, including annotating liquid hemostasis subassembly, annotating liquid device and cervical cover, annotate liquid hemostasis subassembly and including the bleeding stopping bag, annotate liquid pipe, first drainage tube, annotate liquid pipe setting on the inner wall of first drainage tube, the position that first drainage tube is located the bleeding stopping bag top is equipped with the drainage mouth, the cervical cover is located the bleeding stopping bag below, inside is equipped with the gasbag, is equipped with the sliding channel in the middle, and first drainage tube can be at the sliding channel removal, is equipped with limit structure between sliding channel and the first drainage tube, and the cervical cover passes through limit structure detachable to be fixed at first drainage tube outer wall. The air bag in the cervical cover is inflated to clamp the cervical cover between the fornix behind vagina and the inner side of pubic arch, the cervical cover is extruded towards the inner side of cervical opening to enable the cervical opening to be closed, and the cervical cover is further provided with a liquid draining hole, a second drainage tube and a collecting bag. For another example, chinese patent application No. cn202210475406.X discloses an anticreep device of hemostatic balloon for postpartum hemorrhage, including solid fixed ring and elastic clip, when the card of elastic clip is established in solid fixed ring inboard, the clamp mouth of elastic clip sets up towards the cervical mouth, is equipped with the regulation gasbag that is used for adjusting the distance between two clamping pieces in the elastic clip, adjusts the gasbag and fixes in the middle of two clamping pieces. The anti-drop device is matched with the hemostatic bag for use, the hemostatic bag is slowly conveyed into the uterine cavity when in use, after the bottom of the hemostatic bag reaches the bottom of the uterus, water is injected into the hemostatic bag, so that the hemostatic bag presses the uterine cavity, and the adjusting air bag and the pressing air bag of the anti-drop device are inflated, so that the adjusting air bag can outwards expand the two clamping pieces, the elastic clamp is fixed on the adjusting ring by the clamping pieces, and the elastic clamp is continuously inflated, so that gas is injected into the pressing air bag to press the cervical orifice. It can be seen that, after the anti-drop structure of the hemostatic balloon is provided, the hemostatic balloon device forms a multi-pipeline multi-balloon structure, and when performing hemostatic operation, each independent balloon cavity needs to be respectively filled with liquid or inflated to control the inflation of the corresponding balloon.
At present, aiming at the hemostatic balloon device with multiple pipelines and multiple balloons, during clinical operation, the liquid injection pipeline or the air inflation pipeline of the balloon is usually connected with the liquid injection device or the air inflation device by manpower to perform liquid injection or air inflation, when various pipelines and external equipment connected with a patient are more, pipeline confusion is easy to occur, in order to ensure that each pipeline is correctly connected to the corresponding device, medical staff often needs to spend some time to identify and select the pipeline, precious treatment time is occupied, and hemostatic operation efficiency is influenced.
On the other hand, the traditional coelomic hemostatic bag generally adopts a single-cavity balloon, and because the expansion area can not be adjusted when the single-cavity balloon is inflated, the hemostasis by compression of one or more positions is difficult to achieve in a targeted manner, and the regional adjustment requirement of the hemostatic bag is difficult to meet.
On the other hand, after the hemostatic balloon is placed in the body cavity, the inflation state of the hemostatic balloon in the body is mainly judged by the experience of a doctor, the doctor cannot intuitively acquire the condition in the body cavity, the hemostatic difficulty is increased, and the condition that hemostasis by compression is not in place possibly occurs. Accordingly, the prior art also provides a solution for detecting the condition of the balloon in the body cavity by matching with in-vitro ultrasonic detection and the like, but needs the matching of an ultrasonic doctor, and the postpartum hemorrhage often has large hemorrhage amount and high hemorrhage speed, and the time for rescuing is delayed or even missed by placing the hemostatic balloon after the ultrasonic doctor arrives at the scene, so that the operation is inconvenient, and the balloon inflation state and the condition in the body cavity are difficult to stably monitor in real time in the balloon inflation process.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a rapid hemostatic bag and a rapid hemostatic system. The invention provides a rapid hemostatic balloon scheme, which comprises a balloon assembly, a catheter assembly and an inflation distribution assembly, wherein the balloon assembly comprises a plurality of balloons, the inflation distribution assembly is arranged between an inflation device and each balloon pipeline inflation port and is used for determining a target balloon to be inflated when a balloon inflation instruction is received, an infusion passage is formed after the balloon pipeline inflation port corresponding to the target balloon is in butt joint so as to inflate the target balloon by fluid inflation, and the butt joint is released after the inflation is completed, so that the inflation port valve of the target balloon is in a closed state. According to the technical scheme, the balloon infusion device can be automatically docked with the target balloon needing to be inflated with fluid through the inflation distribution assembly according to the balloon inflation instruction so as to form an infusion passage, so that manual operation is reduced, time is saved, and balloon infusion efficiency is improved.
In order to achieve the above object, the present invention provides the following technical solutions:
A rapid hemostatic balloon comprising a balloon catheter comprising a catheter assembly and a balloon assembly, the balloon assembly being disposed on the catheter assembly for connection with an external inflation device;
the balloon assembly comprises a plurality of balloons, and the balloon cavities of the plurality of balloons are mutually independent;
the catheter assembly comprises a plurality of balloon pipelines, the balloon pipelines are arranged in one-to-one correspondence with the balloons, each balloon pipeline respectively communicates the corresponding balloon with the inflation device, and the inflation port of each balloon pipeline is provided with a control valve;
The inflatable balloon catheter also comprises an inflation distribution assembly arranged between the inflation device and each balloon catheter inflation port, wherein the inflation distribution assembly is configured to determine a target balloon to be inflated according to a received balloon inflation instruction, form an infusion passage after the balloon catheter inflation port corresponding to the target balloon is in butt joint so as to inflate the target balloon with fluid, enable an inflation port control valve of the target balloon to be opened at the moment, and release the butt joint after the fluid inflation is completed, and enable the inflation port control valve of the target balloon to be in a closed state.
Further, the balloon assembly includes at least one anti-blood cell balloon and at least one anti-slip balloon, and the catheter assembly includes an anti-blood cell balloon tube and an anti-slip balloon tube;
The hemostatic balloon comprises a main balloon and a plurality of flat auxiliary balloons arranged on the outer surface of the main balloon, wherein cavities of the main balloon and the flat auxiliary balloons are mutually independent, independent main balloon pipelines and a plurality of auxiliary balloon pipelines are respectively arranged corresponding to the main balloon and the flat auxiliary balloons, the auxiliary balloon pipelines are arranged in one-to-one correspondence with the auxiliary balloons, filling ports of the main balloon pipelines can be in butt joint with the filling distribution assemblies to form an infusion passage, and filling ports of the auxiliary balloon pipelines can be in butt joint with the filling distribution assemblies to form the infusion passage.
Further, the balloon catheter is used for hemostasis of uterine cavities, at the moment, the hemostasis balloon is an intrauterine hemostasis balloon, the intrauterine hemostasis balloon comprises a main balloon and a plurality of flat auxiliary balloons arranged on the left side and the right side of the main balloon, the plurality of flat auxiliary balloons are respectively arranged along the left side surface and the right side surface of the main balloon, and the bottoms of the flat auxiliary balloons are attached to the balloon wall of the main balloon;
The anti-slip balloon is arranged in the vagina, is an annular balloon, is clamped in a vaginal fornix at the top end of the vagina after being inflated, wraps the cervix, and closes the internal cervix while lifting the uterine cavity hemostatic balloon;
The catheter assembly further comprises a drainage tube, the distal end of the drainage tube sequentially penetrates through the inner ring of the annular anti-slip balloon and the inner cavity of the intrauterine blood stopping balloon and then stretches out of the intrauterine blood stopping balloon, a drainage port is arranged at the distal end of the drainage tube, and the proximal end of the drainage tube is connected with a drainage device.
Further, the shape of the hemostatic balloon in the uterine cavity is matched with the shape of the uterine cavity, and the hemostatic balloon is in a flat inverted pear shape with the upper part wide and the lower part narrow and the front-back diameter smaller than the left-right diameter.
Further, each balloon in the corresponding balloon assembly is provided with a balloon name and/or a balloon number, the balloon names and/or the balloon numbers are arranged in one-to-one correspondence with the balloons, and the corresponding balloon can be positioned through the balloon names and/or the balloon numbers;
The balloon inflation instruction comprises the balloon name and/or balloon number of the target balloon to be inflated with the fluid and inflation parameter information of the target balloon.
Further, the filling and dispensing assembly comprises a controller and at least one filling and dispensing device, wherein the filling and dispensing device is connected with the controller and receives the control of the controller;
The controller is used for receiving the balloon inflation instruction and determining one or more target balloons to be inflated according to the balloon inflation instruction;
The inflation dispenser comprises a balloon inflation head, an infusion path and a separation device, wherein the balloon inflation head is used for enabling the balloon inflation head to be in butt joint with a balloon pipeline inflation port of a target balloon according to control of a controller so as to form the infusion path, fluid inflation is carried out on the target balloon according to inflation parameter information of the target balloon, and the balloon inflation head is separated from the balloon pipeline inflation port of the target balloon according to control of the controller after inflation is finished.
Further, the filling dispenser includes:
the sliding rod is arranged corresponding to balloon pipeline filling openings of the balloons, and a plurality of balloon pipeline filling openings are arranged in a row along the axial direction of the sliding rod;
The electric sliding block is arranged on the sliding rod and comprises a sliding block part, a first driving part and a second driver, the first end of the sliding block part is provided with the balloon filling head, the first end is one end close to the balloon pipeline filling port, the first driver is used for driving the sliding block part to move on the sliding rod according to control of the controller so as to reach the balloon pipeline filling port position of the target balloon, the second driver is used for driving the balloon filling head to move towards the balloon pipeline filling port of the target balloon according to control of the controller so as to perform butt joint of the balloon filling head and the balloon pipeline filling port, after the butt joint is finished, the filling port control valve of the target balloon is opened, fluid is filled through the balloon filling head, the second driver drives the balloon filling head to reversely move to be separated from the balloon pipeline filling port of the target balloon according to control of the controller, and the first driver drives the sliding block part to move to a target balloon position or return to the initial position on the sliding rod according to control of the controller.
The balloon catheter comprises a balloon catheter, an image acquisition cavity, an optical fiber mirror probe, a connecting joint, a light guide fiber, a lens and a lens, wherein the balloon catheter is arranged in the balloon catheter, and is provided with an image acquisition cavity channel for the optical fiber mirror probe to enter into the balloon cavity of the balloon;
the sliding block part also comprises a shooting butt joint and a light guide butt joint, wherein the shooting butt joint and the light guide butt joint are positioned at the periphery of the balloon inflation head, and when the balloon pipeline inflation port is in butt joint with the balloon inflation head, the shooting butt joint and the light guide butt joint are also in butt joint with the connection joints of the shooting optical fiber and the light guide optical fiber respectively so as to be electrically connected.
The multi-dimensional docking tray comprises a sliding table, a rotating table and a longitudinal shifter, wherein the sliding table, the rotating table and the longitudinal shifter receive the control of a controller, the balloon filling head is arranged on the sliding table of the multi-dimensional docking tray through a traversing mechanism, the traversing mechanism is used for driving the balloon filling head to transversely move on the sliding table, the sliding table is arranged on the rotating table and is used for driving the sliding table to rotate so as to drive the balloon filling head to rotate, the longitudinal shifter is arranged on the longitudinal shifter and is used for driving the rotating table to longitudinally move so as to drive the balloon filling head to be in butt joint or separation with the balloon pipe filling port, and when the balloon filling head is separated from the balloon pipe filling port, the fluid filling operation is stopped;
the rotary butt joint disc comprises a rotary section and a rotary driving structure, wherein the rotary driving structure is used for driving the rotary section to rotate, a plurality of balloon pipeline filling ports are arranged corresponding to the rotary section and are respectively located in different directions of the rotary section, the rotary section comprises an input end and an output end, the input end is used for being connected with a filling device, the rotary driving structure can drive the rotary section to rotate under the control of a controller so that the output end is respectively communicated with the balloon pipeline filling ports in different directions, when the output end is communicated with the target balloon pipeline filling ports, a filling port control valve of the target balloon is opened, and fluid enters the balloon pipeline through the rotary section and then is input into the target balloon.
The present invention also provides a balloon dilation system for uterine cavity hemostasis, the system comprising:
An inflatable balloon, said inflatable balloon being a rapid hemostatic balloon as described above;
The balloon body expansion control device comprises an upper computer facing a user, wherein the upper computer is used for displaying the information of each balloon in the balloon assembly, and after the balloon inflation instruction sent by the user aiming at one or more balloons is acquired, the balloon inflation instruction is sent to the inflation distribution assembly of the rapid hemostatic balloon.
Compared with the prior art, the rapid hemostatic balloon comprises a balloon component, a catheter component and an inflation distribution component, wherein the balloon component comprises a plurality of balloons, the inflation distribution component is arranged between an inflation device and each balloon pipeline inflation port and is used for determining a target balloon to be inflated when a balloon inflation instruction is received, an infusion passage is formed after the balloon pipeline inflation port corresponding to the target balloon is in butt joint so as to inflate the target balloon by inflating fluid, the butt joint is released after the inflation is completed, and the inflation port valve of the target balloon is restored to a closed state. According to the technical scheme, the balloon infusion device can be automatically docked with the target balloon needing to be inflated with fluid according to the balloon inflation instruction through the inflation distribution assembly to form an infusion passage, so that manual operation is reduced, operation time is saved, and balloon infusion efficiency is improved.
On the other hand, a multi-cavity hemostatic balloon with a plurality of auxiliary balloons is provided, a plurality of flat auxiliary balloons are arranged in different areas of the outer surface of the main balloon, one or more auxiliary balloons can be flexibly and conveniently inflated by the inflation distribution assembly according to the received balloon inflation instructions, and accordingly compression hemostasis can be flexibly and efficiently carried out on one or more areas in a body cavity, and regional adjustment requirements of the hemostatic balloons are met.
On the other hand, a plurality of filling dispensers are also designed, and an imaging device connecting part is provided by combining the structure of the filling dispenser, so that a user can stably monitor the balloon inflation state, the condition in a body cavity and other information in real time in the balloon filling process, more visual and accurate reference information is provided for the operation of medical staff, the operation is simple and convenient, and the blindness of balloon inflation in the prior art is avoided.
Drawings
Fig. 1 is a schematic structural diagram of a rapid hemostatic bag according to an embodiment of the present invention.
Fig. 2 is a schematic structural view of a hemostatic balloon including a main balloon and a plurality of flattened auxiliary balloons provided in an embodiment of the present invention.
Fig. 3 is a schematic view of a piping arrangement in a catheter assembly according to an embodiment of the present invention.
Fig. 4 is a logic diagram of information processing of an inflation dispensing assembly according to an embodiment of the present invention.
Fig. 5 is a schematic structural diagram of a first filling dispenser according to an embodiment of the present invention.
Fig. 6 is a schematic diagram of a first embodiment of a filling dispenser according to the present invention.
Fig. 7 is a schematic layout diagram of a balloon catheter inflation port according to an embodiment of the present invention.
Fig. 8 is a schematic structural diagram of a second filling dispenser according to an embodiment of the present invention.
Reference numerals illustrate:
A rapid hemostatic bag 100;
a hemostatic balloon 110, a main balloon 111, left side auxiliary balloons 112, 113, right side auxiliary balloons 114, 115;
Anti-slip balloon 120;
catheter assembly 130, drainage tube 131, balloon tubing 132, linear array of inflation ports 133, circular array of inflation ports 134;
The inflation dispensing assembly 140, inflation dispenser one 142, slide bar 1421, motorized slide 1422, first balloon inflation head 1423, inflation line 1424, camera and light guide docking head 1425, fiberoptic line 1426, inflation dispenser two 144, second balloon inflation head 1441, slide table 1442, swivel table 1443, longitudinal shifter 1444;
A filling device 200;
drainage device 300.
Detailed Description
The rapid hemostatic bag and system of the present disclosure will be described in further detail below with reference to the drawings and examples. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be regarded as being isolated, and they may be combined with each other to achieve a better technical effect. In the drawings of the embodiments described below, like reference numerals appearing in the various drawings represent like features or components and are applicable to the various embodiments. Thus, once an item is defined in one drawing, no further discussion thereof is required in subsequent drawings.
It should be noted that the structures, proportions, sizes, etc. shown in the drawings are merely used in conjunction with the disclosure of the present specification, and are not intended to limit the applicable scope of the present invention, but rather to limit the scope of the present invention. The scope of the preferred embodiments of the present invention includes additional implementations in which functions may be performed out of the order described or discussed, including in a substantially simultaneous manner or in an order that is reverse, depending on the function involved, as would be understood by those of skill in the art to which embodiments of the present invention pertain.
Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but should be considered part of the authorization specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values.
In the description of the embodiment of the present application, "/" means or, and/or "is used to describe the association relationship of the association object, which means that three relationships may exist, for example," a and/or b "means that a single first and a single second exist, and that a single second exists, and that a single first and a single second exist. In the description of the embodiments of the present application, "plurality" means two or more.
Examples
Referring to fig. 1, a rapid hemostatic bag is provided in accordance with the present invention.
The rapid hemostatic balloon 100 includes a balloon catheter including a catheter assembly and a balloon assembly disposed on the catheter assembly and an inflation dispensing assembly disposed corresponding to a proximal end of the catheter assembly.
The balloon assembly comprises a plurality of balloons, and the balloon cavities of the plurality of balloons are mutually independent. The balloon is made of an expandable material such as natural rubber, synthetic rubber, silicone, latex, polyurethane, polyvinyl chloride, polyethylene, nylon, or any other expandable elastomer, polymer, or other material. Preferably, the balloon is made of silicone, with sufficient compliance to generally conform to the shape of the body cavity.
The catheter assembly is connected with an external filling device and is used for filling and discharging fluid to each balloon of the balloon assembly, and the filled fluid can be liquid or gas as required when the balloon is inflated. Specifically, the catheter assembly includes a plurality of balloon pipelines, the balloon pipelines are arranged in one-to-one correspondence with the balloons in the balloon assembly, each balloon pipeline is respectively used for communicating the corresponding balloon with the filling device 200, and the filling ports of each balloon pipeline are provided with control valves to open or close the filling ports.
In this embodiment, the balloon assembly includes at least one hemostatic balloon 110 and at least one anti-slip balloon 120. The hemostatic balloon 110 is disposed at the distal end of the catheter assembly 130 and wrapped around the outer wall of the catheter assembly 130. The anti-slip balloon 120 is disposed corresponding to the hemostatic balloon 110 for preventing the hemostatic balloon 110 from slipping out of the body cavity into which it is placed.
Correspondingly, the balloon pipeline of the catheter assembly 130 comprises a hemostatic balloon pipeline and an anti-slipping balloon pipeline, the hemostatic balloon pipeline and the anti-slipping balloon pipeline are mutually independent, an output port at the distal end of the hemostatic balloon pipeline is communicated with the inner cavity of the hemostatic balloon, an output port at the distal end of the anti-slipping balloon pipeline is communicated with the inner cavity of the anti-slipping balloon, and filling ports are arranged at the proximal ends of the hemostatic balloon pipeline and the anti-slipping balloon pipeline.
The inflation dispensing assembly 140 is mounted at the proximal end of the catheter assembly 130 and is positioned between the inflation device 200 and each balloon catheter inflation port. The inflation dispensing assembly 140 is configured to determine a target balloon to be inflated according to a received balloon inflation instruction, form an infusion path to inflate the target balloon with fluid after docking a balloon tube inflation port corresponding to the target balloon, at which time a inflation port control valve of the target balloon is opened, and release the docking after fluid inflation is completed, the inflation port control valve of the target balloon returning to a closed state.
By way of example and not limitation, if it is determined that the target balloon to be inflated is the anti-slip balloon 120 according to a balloon inflation command, the inflation dispensing assembly 140 is first docked with the balloon tube inflation port corresponding to the anti-slip balloon 120, an infusion path is formed after docking is completed, and then the anti-slip balloon 120 is inflated with fluid, at which time the inflation port control valve of the target balloon is opened. After fluid inflation is complete, inflation dispensing assembly 140 may release the aforementioned interface and the inflation port control valve of the target balloon may return to the closed state.
In one embodiment, the control valve may be a one-way valve, and the one-way valve of the fill port automatically opens to form an infusion path after the anti-slip balloon catheter fill port is docked with the fill dispensing assembly 140, and the anti-slip balloon 120 is inflated by filling fluid through the fill dispensing assembly 140 without the need for manual inflation docking and filling operations (e.g., using a syringe to fill fluid). After the filling is completed, the butt joint is released, and the one-way valve of the filling port of the anti-slip balloon is automatically closed. In another embodiment, the control valve may also employ a solenoid valve coupled to the controller of the fill dispensing assembly 140, capable of receiving control of the controller. After the anti-slip balloon pipeline filling port and the filling distribution assembly 140 are in butt joint, the controller controls the electromagnetic valve of the filling port to be opened to form an infusion passage, the anti-slip balloon 120 is filled with fluid through the filling distribution assembly 140 to expand, and after the filling is completed, the control valve of the filling port of the anti-slip balloon is controlled to be closed, and the butt joint is released. It should be noted that, the specific structure and the opening and closing control of the check valve and the solenoid valve may refer to various check valve and solenoid valve devices existing in the art, which belong to the prior art, and are not described herein again.
When the balloon is required to be taken out in the later period, the fluid in the balloon needs to be discharged first. At this point, the inflation dispensing assembly 140 may be removed from the catheter assembly 130, the inflation dispensing assembly and the inflation device may be separated from the catheter assembly, the balloon catheter inflation port at the proximal end of the catheter assembly may be exposed, and a fluid release operation may be performed, such as connecting the balloon catheter inflation port to a fluid collection device. By way of example and not limitation, when the fluid in the balloon is a liquid, the balloon conduit fill port may be connected to a liquid collection bag for collecting the liquid, and after the control valve is opened, the liquid in the balloon is discharged into the liquid collection bag through the balloon conduit.
In this embodiment, the hemostatic balloon may adopt a multi-balloon cavity structure, and may include a main balloon and a plurality of flat auxiliary balloons disposed on the outer surface of the main balloon, where the cavities of the main balloon and the flat auxiliary balloon are independent from each other. At this time, an independent main balloon pipe and a plurality of auxiliary balloon pipes may be respectively provided corresponding to the main balloon and the plurality of flat auxiliary balloons, and each auxiliary balloon pipe is provided in one-to-one correspondence with an auxiliary balloon. The inflation ports of the primary balloon conduits are capable of interfacing with the inflation dispensing assemblies to form an infusion path, and the inflation ports of the secondary balloon conduits are capable of interfacing with the inflation dispensing assemblies to form an infusion path, respectively.
When the balloon catheter is used for hemostasis of uterine cavity, the hemostasis balloon 110 is an intrauterine hemostasis balloon, and at this time, the shape of the intrauterine hemostasis balloon is preferably configured to be matched with the shape of the uterine cavity, and is a flat inverted pear shape with wide upper part, narrow lower part, front-back part and smaller left-right part.
As an example of a typical manner, referring to fig. 2, the intrauterine hemostatic balloon includes a main balloon 111 and a plurality of flat sub-balloons disposed at both left and right sides of the main balloon 111, each of which may have the same shape and size, and the plurality of flat sub-balloons are respectively arranged along left and right sides of the main balloon with bottoms of the flat sub-balloons attached to a balloon wall of the main balloon, thereby forming left and right sub-balloons.
The left side auxiliary balloon and the right side auxiliary balloon can be symmetrically arranged relative to the main balloon. When inflation is needed, the main balloon, the left side auxiliary balloon and the right side auxiliary balloon are filled with fluid through the inflation distribution assembly. The main saccule is mainly used for pressing the front wall and the rear wall of the uterus after being inflated, and the left side auxiliary saccule and the right side auxiliary saccule are respectively mainly used for pressing the left side wall and the right side wall of the uterus after being inflated. In particular, after the lower parts of the balloon bodies of the left side auxiliary balloon and the right side auxiliary balloon are inflated, the uterine artery ascending branch at the lower uterine segment can be effectively pressed to effectively stop bleeding.
As a preferred example, in fig. 2, the left side auxiliary balloon and the right side auxiliary balloon are both 2, that is, at this time, the surface of the main balloon 111 is distributed with 4 flat auxiliary balloons, the upper auxiliary balloons of the left side auxiliary balloon and the right side auxiliary balloon respectively correspond to the uterine angle area of the uterine cavity for compression hemostasis of the uterine angle area, and the lower auxiliary balloons of the left side auxiliary balloon and the right side auxiliary balloon respectively correspond to the uterine artery uplink branch areas on the left side and the right side of the uterine cavity for directly blocking the uterine artery uplink branch, thereby effectively stopping hemostasis. Therefore, the special area can be subjected to compression hemostasis according to the tissue characteristics of the uterine cavity, the bleeding position of the patient and other information, and the regional regulation requirement of the hemostasis saccule is met. More preferably, the balloon wall in this embodiment may include a thickened region to guide the balloon more inflation toward the thinner balloon wall region, taking advantage of the inflation characteristics of the balloon. Specifically, the balloon wall of the connection region of the main balloon and the flat auxiliary balloon can be thickened to limit the expansibility of the balloon in the connection region, so that the expansion of the balloon is guided to the thinner non-connection region of the balloon wall of each balloon, and the expansion of the balloon appears as the non-connection region of the balloon when the balloon is expanded to be more obvious, thus the intrauterine hemostatic balloon is expanded to the outer side more when the intrauterine hemostatic balloon is filled, and the lumen wall can be better pressed.
The number and positions of the left side sub-balloon and the right side sub-balloon are given by way of example and not limitation, and those skilled in the art can set a larger number of sub-balloons on the main balloon as required when designing the hemostatic balloon, and are not limited to the left and right side positions of the main balloon.
The anti-slip balloon is arranged in the vagina, is preferably an annular balloon and is similar to the structure of a swimming ring. The anti-slip balloon is clamped in a vaginal vault at the top end of the vagina after being inflated and surrounds the cervix, and the cervical internal opening is closed while the uterine cavity hemostatic balloon is lifted. That is, the anti-slip balloon needs to be formed to be able to wrap around the cervical canal after inflation. Specifically, the inner cavity of the annular balloon body of the anti-slip balloon is used for filling fluid, the annular balloon body forms an inner ring, the inner ring is matched with the cervical peripheral size of the vaginal fornix, and meanwhile, the annular balloon body is matched with the vaginal fornix in size, so that the anti-slip balloon can be clamped in the vaginal fornix at the top end of the vagina and wrapped around the cervical after being inflated. The annular balloon body is provided with an opening serving as an inflation hole for enabling fluid in the anti-slip balloon pipeline to enter the inner cavity of the annular balloon body, so that the annular balloon body is inflated.
Preferably, when used for uterine cavity hemostasis, the inflation fluid of each balloon is a liquid, such as saline.
The catheter assembly 130 further includes a drainage tube 131, see fig. 3, in view of the drainage requirements of uterine cavity hemostasis. The distal end of the drainage tube 131 sequentially passes through the inner ring of the annular anti-slip balloon and the inner cavity of the intrauterine hemostat and then extends out of the intrauterine hemostat. The distal end of the drainage tube 131 (located in the uterine cavity) is provided with drainage ports for draining the blood accumulation in the uterine cavity, and one or more drainage ports can be used as required. The proximal end of the drainage tube is connected to the drainage device 300. Preferably, the length of the upper end of the drainage tube extending out of the hemostatic bag in the uterine cavity is 5-15mm.
The balloon pipes 132 of the catheter assembly may be provided independently of the drainage tube 131, or may be provided so as to be attached to the drainage tube 131. In fig. 3, a case where the balloon tube 132 and the drainage tube 131 are independently provided is illustrated, and at this time, the catheter assembly may be divided into a balloon tube subchamber and a drainage tube subchamber, in which a plurality of balloon tubes are disposed, and the drainage tube subchamber may directly form the drainage tube.
In this embodiment, a balloon name and/or a balloon number are configured corresponding to each balloon in the balloon assembly, and the balloon name and/or the balloon number are arranged in one-to-one correspondence with the balloons, so that the corresponding balloon and other balloons can be distinguished by the balloon name and/or the balloon number. For example, as shown in fig. 4, the number of the balloon in the balloon assembly is Xm1, the number of the primary balloon can be mapped to the primary balloon of the hemostatic balloon X in the balloon assembly through the number Xm1, the number of the secondary balloons is 4, the numbers are sequentially configured to be Xn1, xn2, xn3 and Xn4, the number of the secondary balloons can be mapped to the hemostatic balloon X in the balloon assembly through the numbers Xn1, xn2, xn3 and Xn4, the number of the anti-slip balloons is only 1, the number of the anti-slip balloon is Y1, and the number of the secondary balloons can be mapped to the slipping balloon in the balloon assembly through the number Y1. It should be noted that, the above configuration manner of the balloon number is taken as an example and not as a limitation, and those skilled in the art may adaptively configure the balloon name and/or the data format of the balloon number according to the need, so long as the balloon name and/or the balloon number can be mapped to the specific balloon corresponding thereto, and the configuration of the balloon name and/or the data format of the balloon number should not be taken as a limitation of the present invention.
At this time, the balloon inflation instruction includes the balloon name and/or balloon number of the target balloon to be inflated with the fluid, and inflation parameter information of the target balloon.
The filling parameter information may specifically include information such as a fluid type, a filling flow rate, a filling speed, and/or a filling time of the filling. When there are a plurality of target balloons to be inflated, the inflation parameter information may further include inflation sequence information of the plurality of target balloons.
When the device is specifically arranged, the inflation distribution assembly can be provided with a man-machine interaction interface to collect balloon inflation instructions of a user. In one embodiment, the man-machine interaction interface is a key area arranged on the inflation distribution assembly, the key area is provided with operation keys respectively used for inflating a plurality of balloons, and a user sends out balloon inflation instructions for the target balloons by triggering the corresponding keys. For example, when the user needs to inflate the main balloon of the hemostatic balloon, the user can press the operation key corresponding to the main balloon in the key area, at this time, the controller receives the balloon inflation instruction of the main balloon of the hemostatic balloon, and starts the inflation operation of the main balloon of the hemostatic balloon according to the instruction. When the user needs to fill the anti-slip balloon, the user can press the operation key corresponding to the anti-slip balloon in the key area, at this time, the controller receives the balloon filling instruction aiming at the anti-slip balloon, and starts the filling operation of the anti-slip balloon according to the instruction. In another embodiment, the man-machine interaction interface comprises a touch operation screen arranged on the inflation distribution assembly, a balloon inflation information acquisition column is arranged on the touch operation screen, and after balloon information (i.e. a target balloon) input/selected by a user is acquired through the balloon inflation information acquisition column, a balloon inflation instruction comprising a main balloon for the target balloon, such as a blood stopping balloon, is sent to the controller. After receiving the balloon inflation instruction for the main balloon of the hemostatic balloon, the controller starts the inflation operation of the main balloon of the hemostatic balloon according to the instruction.
Or the inflation distribution assembly is in communication connection with the associated user terminal and is used for receiving the balloon inflation instruction sent by the user terminal. At this time, the balloon inflation instruction may further include terminal ID information of the user terminal and user authentication information, where the user authentication information is used to verify validity of the balloon inflation instruction. When the authentication of the user identity authentication information fails, the filling distribution component judges that the filling instruction is illegal, at the moment, the filling distribution component feeds back authentication failure information to the user terminal corresponding to the terminal ID, and sends out alarm information through the associated alarm. The alarm may be provided on the fill dispensing assembly or on other associated terminals, and the alarm information may be an audible and/or illuminated alert.
Referring to fig. 4, the fill dispensing assembly may include a controller and at least one fill dispenser coupled to and receiving control of the controller.
The controller is used for receiving the balloon inflation instruction and determining one or more target balloons to be inflated according to the balloon inflation instruction.
The inflation dispenser comprises a balloon inflation head, an infusion path and a separation device, wherein the balloon inflation head is used for enabling the balloon inflation head to be in butt joint with a balloon pipeline inflation port of a target balloon according to control of a controller so as to form the infusion path, fluid inflation is carried out on the target balloon according to inflation parameter information of the target balloon, and the balloon inflation head is separated from the balloon pipeline inflation port of the target balloon according to control of the controller after inflation is finished.
Referring to fig. 5, one specific construction of a fill dispenser is illustrated.
At this time, the balloon tube inflation ports of each balloon form a balloon tube inflation port linear array 133 at the proximal end of the catheter assembly, i.e., a plurality of balloon tube inflation ports are aligned in a row along the axial direction of the slide bar, and the inflation dispenser employs inflation dispenser one 142.
The first fill dispenser 142 includes a slide bar 1421 and a motorized slide bar 1422 mounted thereon.
The sliding rod 1421 is disposed corresponding to each balloon catheter inflation port of the balloon catheter inflation port linear array 133, and the length of the sliding rod 1421 is matched with the arrangement length of the balloon catheter inflation ports.
The motorized slider 1422 includes a first drive section and a second drive (not shown). The motorized slider 1422 is movable integrally with the slide bar 1421. The first driving part and the second driver may adopt micro linear motors.
The first end of the slider portion is provided with the balloon inflation head, i.e., the first balloon inflation head 1423, and the first end is an end close to the balloon pipeline inflation port. The second end of the slider part is connected to the output end of the filling pipe 1424, and the input end of the filling pipe 1424 is connected to the filling device. The slide block part is provided with a through pipeline for communicating the inner cavity of the first balloon filling head 1423 and the filling pipeline 1424, and fluid sequentially passes through the filling pipeline 1424, the slide block part pipeline and the inner cavity of the balloon filling head and then enters the balloon pipeline filling port.
The first driver is used for driving the sliding block part to move on the sliding rod according to the control of the controller so as to reach the balloon pipeline filling port position of the target balloon. The second driver is used for driving the first balloon inflation head 1423 to move towards the direction of the balloon pipeline inflation port of the target balloon according to the control of the controller so as to perform the butt joint of the first balloon inflation head 1423 and the balloon pipeline inflation port, and after the butt joint is completed, the inflation port control valve of the target balloon is opened to form an infusion passage, and fluid is inflated to the current balloon through the balloon inflation port 1423. The controller monitors the inflation process and, upon determining that inflation is complete, controls the second driver to actuate, driving the first balloon inflation head 1423 in a reverse motion to separate from the balloon conduit inflation port of the target balloon.
After the separation is completed, the controller can control the first driver to start so as to drive the sliding block part to move to a target balloon position on the sliding rod or return to the initial position.
Preferably, an image acquisition cavity channel can be arranged in each balloon pipeline correspondingly so that the optical fiber mirror probe can enter the balloon cavity of the balloon to acquire the image information of the body cavity. At this time, each balloon is made of transparent material.
The image pickup optical fiber (or called imaging optical fiber bundle) and the light guide optical fiber (or called illumination optical fiber bundle) are positioned in the image acquisition cavity, the optical fiber mirror probe is positioned at the far end of the image acquisition cavity and enters the corresponding balloon cavity, and meanwhile, the connecting joint of the image pickup optical fiber and the light guide optical fiber is arranged at the balloon pipeline filling port for electric connection, and the image pickup optical fiber and the light guide optical fiber are shown in fig. 6.
At this time, the slider part further includes a camera abutment and a light guide abutment 1425, and the camera abutment and the light guide abutment 1425 are located at the periphery of the first balloon inflation head 1423, for example, may be located below, above, left or right of the first balloon inflation head 1423. When the balloon catheter inflation port is in butt joint with the first balloon inflation head 1423, the camera butt joint and the light guide butt joint 1425 at the periphery of the first balloon inflation head 1423 are also in butt joint with the connection joints of the camera optical fiber and the light guide optical fiber on the balloon catheter inflation port respectively so as to be electrically connected, and the other ends of the camera butt joint and the light guide butt joint 1425 are respectively connected with external image equipment and an external light source through the optical fiber mirror circuit 1426. Therefore, when the balloon pipeline filling port is in butt joint with the balloon filling head, the optical fiber mirror probe can be electrically connected with external imaging equipment and an external light source, and uterine cavity image information acquired by the probe can be displayed through the external imaging equipment, so that the balloon inflation state, the balloon position, the condition in a body cavity and the like can be monitored stably in real time in the balloon filling process.
In another implementation of this embodiment, when the balloon tubing inflation ports of each balloon form a circular array 134 of balloon tubing inflation ports at the proximal end of the catheter assembly, as shown in FIG. 7, another inflation dispenser may be used.
Referring to fig. 8, a specific configuration of a second fill dispenser 144 is illustrated.
At this time, the filling dispenser includes a multidimensional docking tray, the upper plane of the multidimensional docking tray is provided with the balloon filling head, that is, the second balloon filling head 1441, and the plurality of balloon pipe filling ports are arranged on the same plane and the plane is parallel to the upper plane of the multidimensional docking tray.
The multi-dimensional docking plate includes a sliding table 1442, a rotating table 1443, and a longitudinal shifter 1444, and the sliding table 1442, the rotating table 1443, and the longitudinal shifter 1444 receive control of a controller.
When the balloon inflating device is specifically arranged, the second balloon inflating head 1441 is arranged on the sliding table 1442 of the multi-dimensional butt joint disc through a traversing mechanism, and the traversing mechanism is used for driving the balloon inflating head to transversely move on the sliding table. The sliding table 1442 is mounted on a rotating table 1443, and the rotating table 1443 is used for driving the sliding table 1442 to rotate, so as to drive the second balloon inflation head 1441 to rotate. The rotating table 1443 is mounted on a longitudinal shifter 1444, and the longitudinal shifter 1444 is used for driving the rotating table 1443 to move in the longitudinal direction, so as to drive the second balloon inflation head 1441 to be in butt joint with or separated from the balloon pipeline inflation port. When the balloon inflation head is separated from the balloon conduit inflation port, the fluid injection operation is stopped.
At this time, the controller is configured to control the sliding table and/or the rotating table of the multi-dimensional docking tray to work to adjust the position of the balloon inflation head in the lateral and/or circumferential directions to move to the balloon duct inflation port of the target balloon, respectively, after determining that the target balloon needs to be inflated, and to control the longitudinal shifter of the multi-dimensional docking tray to work to drive the balloon inflation head to dock with the balloon duct inflation port of the target balloon, and to inject fluid into the balloon duct inflation port after docking is completed.
In this embodiment, when an image collecting channel (for passing through the image capturing optical fiber and the light guiding optical fiber) is provided corresponding to each balloon tube, a connection joint of the image capturing optical fiber and the light guiding optical fiber is also provided at each balloon tube filling port for electrical connection. At this time, the periphery of the balloon filling head on the upper plane of the multidimensional docking tray may also be provided with the aforementioned image pickup docking head and light guide docking head, which may be located below, above, to the left or to the right of the balloon filling head. When the balloon filling head is in butt joint with one balloon pipeline filling port, the camera shooting butt joint and the light guide butt joint at the periphery of the balloon filling head are also in butt joint with the connecting joints of the camera shooting optical fiber and the light guide optical fiber on the balloon pipeline filling port respectively to be electrically connected, and the other ends of the camera shooting butt joint and the light guide butt joint can be connected with external image equipment and an external light source respectively through optical fiber mirror circuits.
In another implementation of this embodiment, the filling dispenser employs a rotary docking plate, where the rotary docking plate may include a rotary segment and a rotary driving structure, where the rotary driving structure is configured to drive the rotary segment to rotate, and the plurality of balloon catheter filling ports are disposed corresponding to the rotary segment and are respectively located in different orientations of the rotary segment.
The rotary section comprises an input end and an output end, wherein the input end and the output end are communicated through an inner cavity in the rotary section, the input end is used for being connected with a filling device, and the rotary driving structure can drive the rotary section to rotate under the control of the controller so that the output end is respectively communicated with the filling ports of the balloon pipelines in different directions. When the output end is communicated with the filling port of the target balloon pipeline, the control valve of the filling port of the target balloon is opened, and fluid enters the balloon pipeline through the rotating section and is input into the target balloon.
In this embodiment, when an image collecting channel (for passing through the image capturing optical fiber and the light guiding optical fiber) is provided corresponding to each balloon tube, a connection joint of the image capturing optical fiber and the light guiding optical fiber is also provided at each balloon tube filling port for electrical connection. In this case, the imaging butt joint and the light guide butt joint may be provided near the output end of the rotating section. When the output end is in butt joint with one balloon pipeline filling port, the shooting butt joint and the light guide butt joint near the output end are also in butt joint with the connecting joints of the shooting optical fiber and the light guide optical fiber on the balloon pipeline filling port respectively for electric connection, and the other ends of the shooting butt joint and the light guide butt joint are connected with external image equipment and an external light source respectively through optical fiber mirror circuits.
In this embodiment, the plurality of balloons in the balloon assembly may be further configured with type attribute information, that is, the balloons are divided into a plurality of types, and at this time, a dedicated inflation dispenser may be configured for each type of balloon, and a plurality of balloons belonging to the same type may be inflated with fluid through the dedicated inflation dispenser. The plurality of filling dispensers are connected with the controller and receive the control of the controller, at this time, the balloon filling instruction can also comprise type attribute information of the balloon, and according to the type attribute information, the controller controls the corresponding special filling dispenser to fill the fluid for the target balloon. On one hand, the inflatable balloon inflation device can simultaneously inflate a plurality of types of balloons through a plurality of inflation dispensers, so that inflation efficiency is improved, and on the other hand, different inflation dispensers can be configured to inflate different fluids to different types of balloons, so that inflation requirements of more application scenes can be met.
In another embodiment of the present invention, there is also provided a balloon dilation system for uterine cavity hemostasis, the system comprising an inflatable balloon and a balloon dilation control means.
The inflatable balloon body is the rapid hemostatic balloon, and the balloon assembly comprises a hemostatic balloon used for being placed in a uterine cavity and an anti-slip balloon used for being placed in a vagina.
The balloon body expansion control device comprises an upper computer, such as a PC (personal computer), which faces a user, wherein the upper computer is used for displaying the information of each balloon in the balloon assembly, and after the balloon filling instruction sent by the user for one or more balloons is acquired, the balloon filling instruction is sent to the filling distribution assembly of the rapid hemostatic balloon.
For example, a balloon list of the balloon assembly can be displayed on a display screen of the upper computer, and each balloon information is displayed through the balloon list, meanwhile, operation options are arranged in the balloon list corresponding to each balloon, and selected information of the balloon by a user is collected through the operation options, for example, the user triggers the operation options through a mouse to select one or more balloons in the balloon list, and the selected balloon is the target balloon which needs to be filled with fluid at the time.
And each balloon in the corresponding balloon list is further provided with an inflation parameter acquisition column, and after the target balloon is selected, a user can configure inflation parameter information of the target balloon through the inflation parameter acquisition column. The filling parameter information may specifically include information such as a fluid type, a filling flow rate, a filling speed, and/or a filling time of the filling. When the target balloon selected by the user is multiple, the inflation parameter information may further include inflation sequence information of the multiple target balloons. The fill sequence parameters may be configured by the user according to hemostatic requirements.
In this embodiment, when the catheter assembly of the balloon catheter is a flexible catheter, the system may further comprise a balloon boosting device. The balloon boosting device is detachably connected with the catheter assembly and is used for being attached to or inserted into the catheter assembly when the balloon is placed in the uterus cavity to support the catheter assembly, so that the uterus cavity hemostatic balloon is guided to be placed in the uterus bottom or the upper section of the uterus cavity.
Optionally, the balloon boosting device is a guide tube, a guide tube sub-cavity can be arranged on a drainage tube of the catheter assembly for insertion of the guide tube, the hardness of the guide tube is greater than that of the drainage tube of the catheter assembly, the hardness of the guide tube is used for improving the bending resistance and toughness of the balloon catheter, and after the balloon is put in place, the guide tube can be separated from the catheter assembly to take out the guide tube. The guide tube is provided with scales for indicating the position of the balloon delivered to the uterine cavity.
Optionally, the system may further comprise a cervical band for horizontal cerclage to close the endocervical opening. In particular arrangements, the cervical ring binder may be a wide nylon band that is attached to a catheter assembly (e.g., a drainage tube) and positioned to correspond to the location of the anti-slip balloon. After the hemostatic bag is placed in the uterine cavity, a proper amount of liquid is filled to ensure that the saccule is positioned at the upper section or the uterine bottom of the uterine cavity, then the saccule is clung to fornix in vagina, cervical ring is pricked for one circle as close to the internal opening of cervix as possible to prevent the hemostatic bag from slipping, and then the hemostatic bag is continuously filled until the whole saccule is completely clung to the uterine cavity. The cervical ligation band is directly wound around the cervical, no suture is needed, and the damage to the cervical is reduced. Meanwhile, for postpartum hemorrhage patients after vaginal delivery, such as cervical laceration, the cervical laceration can be stopped after cerclage without stitching.
Preferably, the cervical ring binder comprises a ring binder and a telescopic buckle, and the telescopic buckle can adjust the tightness of the ring binder.
When the hemostatic balloon is used, after the unexpanded hemostatic balloon is placed in the uterine cavity, a proper amount of liquid is filled into the main balloon of the hemostatic balloon through the filling and distributing assembly to ensure that the hemostatic balloon is positioned at the upper section or the uterine bottom of the uterine cavity, then the cervical ring is tightly clung to the fornix in the vagina and is pricked for one circle as close to the level of the internal opening of the uterine neck as possible to prevent the hemostatic balloon from slipping, then the main balloon and the auxiliary balloon of the hemostatic balloon are continuously filled until the whole balloon is completely attached to the uterine cavity, and the circular tying belt is directly tied around the uterine neck for one circle without suturing, so that the uterine neck is not damaged. Then, the anti-slip balloon in the vagina is filled to be clamped in the vaginal fornix, and the intrauterine hemostatic balloon is lifted by the anti-slip balloon to strengthen the ring binding belt to close the intrauterine opening. Under the dual functions of the ring binding belt and the anti-slip balloon, the cervical internal opening can be better closed so as to prevent the hemostatic balloon in the uterine cavity from slipping off, and the cervical can be kept or recovered to a normal anatomical structure so as to be beneficial to hemostasis, and meanwhile, the blood accumulation in the uterine cavity is not influenced.
When the hemostatic balloon is taken out, firstly, the liquid of the hemostatic balloon in the uterine cavity is put out, then the liquid of the anti-slip balloon is put out, and finally, the cervical ring binding belt is removed.
Other technical features are described in the previous embodiments and are not described in detail here.
In the above description, the disclosure of the present invention is not intended to limit itself to these aspects. Rather, the components may be selectively and operatively combined in any number within the scope of the present disclosure. In addition, the image "includes
Terms "comprising" and "having" are to be construed by default as inclusive or open-ended, and not exclusive or closed-ended, unless expressly defined to the contrary. All technical, scientific, or other terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Common terms found in dictionaries should not be too idealized or too unrealistically interpreted in the context of the relevant technical document unless the present disclosure explicitly defines them as such. Any alterations and modifications of the present invention, which are made by those of ordinary skill in the art based on the above disclosure, are intended to be within the scope of the appended claims.

Claims (10)

1.一种快速止血球囊,包括球囊导管,所述球囊导管包括导管组件和球囊组件,所述球囊组件设置在导管组件上,所述导管组件用于与外部的充注装置连接,其特征在于:1. A rapid hemostatic balloon, comprising a balloon catheter, the balloon catheter comprising a catheter assembly and a balloon assembly, the balloon assembly being arranged on the catheter assembly, the catheter assembly being used to connect with an external filling device, characterized in that: 所述球囊组件包括多个球囊,多个球囊的囊腔相互独立;The balloon assembly includes a plurality of balloons, and the cavities of the plurality of balloons are independent of each other; 所述导管组件包括多个球囊管道,球囊管道与球囊一一对应设置,各球囊管道分别将对应的球囊与前述充注装置连通,各球囊管道的充注口设置有控制阀;The catheter assembly includes a plurality of balloon conduits, each of which is arranged in one-to-one correspondence with the balloon, each of which connects the corresponding balloon to the aforementioned filling device, and a control valve is arranged at the filling port of each balloon conduit; 还包括设置在充注装置与各球囊管道充注口之间的充注分配组件,所述充注分配组件被配置为:根据接收到的球囊充注指令确定需要充注的目标球囊,在与所述目标球囊对应的球囊管道充注口对接后形成输注通路以向所述目标球囊充注流体使其膨胀,此时目标球囊的充注口控制阀打开;以及在流体充注完成后解除前述对接,目标球囊的充注口控制阀恢复关闭状态。It also includes a filling distribution component arranged between the filling device and the filling ports of each balloon tube, and the filling distribution component is configured to: determine the target balloon that needs to be filled according to the received balloon filling instruction, form an infusion passage after docking with the balloon tube filling port corresponding to the target balloon to fill the target balloon with fluid to expand it, and at this time, the filling port control valve of the target balloon is opened; and release the aforementioned docking after the fluid filling is completed, and the filling port control valve of the target balloon returns to a closed state. 2.根据权利要求1所述的快速止血球囊,其特征在于:所述球囊组件包括至少一个止血球囊和至少一个防滑脱球囊,所述导管组件包括止血球囊管道和防滑脱球囊管道;2. The rapid hemostatic balloon according to claim 1, characterized in that: the balloon assembly comprises at least one hemostatic balloon and at least one anti-slip balloon, and the catheter assembly comprises a hemostatic balloon conduit and an anti-slip balloon conduit; 所述止血球囊包括主球囊和设置在所述主球囊外表面的多个扁平副球囊,主球囊和扁平副球囊的腔体相互独立;对应所述主球囊和多个扁平副球囊分别设置有独立的主球囊管道和多个副球囊管道,副球囊管道与副球囊一一对应设置,所述主球囊管道的充注口能够与前述充注分配组件进行对接以形成输注通路,各副球囊管道的充注口能够分别与前述充注分配组件进行对接以形成输注通路。The hemostatic balloon includes a main balloon and a plurality of flat subsidiary balloons arranged on the outer surface of the main balloon, and the cavities of the main balloon and the flat subsidiary balloons are independent of each other; independent main balloon pipes and a plurality of subsidiary balloon pipes are respectively arranged corresponding to the main balloon and the plurality of flat subsidiary balloons, and the subsidiary balloon pipes are arranged one by one corresponding to the subsidiary balloons, and the filling port of the main balloon pipe can be connected with the aforementioned filling distribution component to form an infusion passage, and the filling ports of each subsidiary balloon pipe can be connected with the aforementioned filling distribution component to form an infusion passage. 3.根据权利要求2所述的快速止血球囊,其特征在于:所述球囊导管用于子宫腔止血,此时,所述止血球囊为宫腔内止血球囊,所述宫腔内止血球囊包括主球囊和设置在所述主球囊左右两侧的多个扁平副球囊,所述多个扁平副球囊分别沿主球囊的左侧面和右侧面排列且扁平副球囊底部贴于主球囊的囊壁上;3. The rapid hemostatic balloon according to claim 2, characterized in that: the balloon catheter is used for hemostasis in the uterine cavity, in which case the hemostatic balloon is an intrauterine hemostatic balloon, the intrauterine hemostatic balloon comprising a main balloon and a plurality of flat auxiliary balloons arranged on the left and right sides of the main balloon, the plurality of flat auxiliary balloons are arranged along the left and right sides of the main balloon respectively, and the bottom of the flat auxiliary balloon is attached to the balloon wall of the main balloon; 所述防滑脱球囊置于阴道内,所述防滑脱球囊为环形囊,在膨胀后卡固在阴道顶端的阴道穹窿内并包绕宫颈,对前述宫腔止血球囊进行托举的同时闭合宫颈内口;The anti-slip balloon is placed in the vagina. The anti-slip balloon is a ring-shaped balloon, which is fixed in the vaginal fornix at the top of the vagina and surrounds the cervix after expansion, lifting the aforementioned uterine cavity hemostasis balloon while closing the internal cervical os; 所述导管组件还包括引流管,所述引流管远端依次穿过环形防滑脱球囊的内圈、宫腔内止血球囊的内腔后伸出宫腔内止血球囊外,引流管远端设置引流口,引流管的近端连接引流装置。The catheter assembly also includes a drainage tube, the distal end of which passes through the inner ring of the annular anti-slip balloon and the inner cavity of the intrauterine hemostatic balloon in sequence and then extends out of the intrauterine hemostatic balloon. A drainage port is arranged at the distal end of the drainage tube, and the proximal end of the drainage tube is connected to a drainage device. 4.根据权利要求3所述的快速止血球囊,其特征在于:所述宫腔内止血球囊的形状与子宫腔的形状适配,呈上宽下窄、前后径小于左右径的扁平状倒置梨形。4. The rapid hemostatic balloon according to claim 3 is characterized in that the shape of the intrauterine hemostatic balloon is adapted to the shape of the uterine cavity, and is a flat inverted pear shape with a wide top and a narrow bottom, and a front-to-back diameter smaller than a left-to-right diameter. 5.根据权利要求1-4中任一项所述的快速止血球囊,其特征在于:对应球囊组件中的每个球囊配置球囊名称和/或球囊编号,所述球囊名称和/或球囊编号与球囊一一对应设置,通过球囊名称和/或球囊编号能够定位到对应的球囊;5. The rapid hemostatic balloon according to any one of claims 1-4, characterized in that: a balloon name and/or balloon number is configured for each balloon in the balloon assembly, and the balloon name and/or balloon number are set in one-to-one correspondence with the balloon, and the corresponding balloon can be located by the balloon name and/or balloon number; 所述球囊充注指令中包括需要进行流体充注的目标球囊的球囊名称和/或球囊编号,以及目标球囊的充注参数信息。The balloon filling instruction includes the balloon name and/or balloon number of the target balloon that needs to be filled with fluid, and filling parameter information of the target balloon. 6.根据权利要求5所述的快速止血球囊,其特征在于:所述充注分配组件包括控制器和至少一个充注分配器,充注分配器与控制器连接并接收控制器的控制;6. The rapid hemostatic balloon according to claim 5, characterized in that: the filling distribution assembly comprises a controller and at least one filling distributor, the filling distributor is connected to the controller and receives control of the controller; 所述控制器,用于接收球囊充注指令,并根据所述球囊充注指令确定需要充注的一个或多个目标球囊;The controller is used to receive a balloon filling instruction and determine one or more target balloons to be filled according to the balloon filling instruction; 所述充注分配器包括球囊充注头,用于根据控制器的控制使球囊充注头与目标球囊的球囊管道充注口对接以形成输注通路,并根据目标球囊的充注参数信息对目标球囊进行流体充注;以及在充注结束后,根据控制器的控制使球囊充注头与目标球囊的球囊管道充注口分离。The filling distributor includes a balloon filling head, which is used to connect the balloon filling head with the balloon tube filling port of the target balloon to form an infusion passage according to the control of the controller, and to fill the target balloon with fluid according to the filling parameter information of the target balloon; and after the filling is completed, the balloon filling head is separated from the balloon tube filling port of the target balloon according to the control of the controller. 7.根据权利要求6所述的快速止血球囊,其特征在于,所述充注分配器包括:7. The rapid hemostatic balloon according to claim 6, characterized in that the filling distributor comprises: 滑杆,对应着各球囊的球囊管道充注口设置,多个球囊管道充注口沿滑杆的轴向排成一列;The slide bar is provided corresponding to the balloon pipeline filling port of each balloon, and the multiple balloon pipeline filling ports are arranged in a row along the axial direction of the slide bar; 安装在滑杆上的电动滑块,所述电动滑块包括滑块部、第一驱动部和第二驱动器,所述滑块部的第一端安装前述球囊充注头,所述第一端为靠近球囊管道充注口的一端;所述第一驱动器用于根据控制器的控制驱动所述滑块部在滑杆上移动以到达目标球囊的球囊管道充注口位置;所述第二驱动器用于根据控制器的控制驱动球囊充注头向目标球囊的球囊管道充注口的方向运动以进行球囊充注头与球囊管道充注口的对接,对接完成后目标球囊的充注口控制阀打开,通过球囊充注头充注流体;充注完成后,第二驱动器根据控制器的控制驱动球囊充注头反向运动以与目标球囊的球囊管道充注口分离,第一驱动器根据控制器的控制驱动所述滑块部在滑杆上移动至一个目标球囊位置或者返回初始位置。An electric slider installed on a slide bar, the electric slider includes a slider part, a first driving part and a second driving part, the first end of the slider part is installed with the aforementioned balloon filling head, the first end being an end close to the balloon tube filling port; the first driving part is used to drive the slider part to move on the slide bar to reach the balloon tube filling port position of the target balloon according to the control of the controller; the second driving part is used to drive the balloon filling head to move in the direction of the balloon tube filling port of the target balloon according to the control of the controller to dock the balloon filling head with the balloon tube filling port, after the docking is completed, the filling port control valve of the target balloon is opened, and the fluid is filled through the balloon filling head; after the filling is completed, the second driving part drives the balloon filling head to move in the opposite direction according to the control of the controller to separate from the balloon tube filling port of the target balloon, and the first driving part drives the slider part to move on the slide bar to a target balloon position or return to the initial position according to the control of the controller. 8.根据权利要求7所述的快速止血球囊,其特征在于:对应各球囊管道中还设置有影像采集腔道以供光纤镜探头进入球囊的囊腔内,各球囊采用透明材质制作;摄像光纤和导光光纤位于影像采集腔道中,光纤镜探头位于影像采集腔道的远端且进入对应的球囊内腔,同时,在球囊管道充注口设置摄像光纤和导光光纤的连接接头;8. The rapid hemostatic balloon according to claim 7 is characterized in that: an image acquisition cavity is also provided in each corresponding balloon pipeline for the fiberoptic scope probe to enter the balloon cavity, and each balloon is made of a transparent material; the imaging fiber and the light guide fiber are located in the image acquisition cavity, the fiberoptic scope probe is located at the distal end of the image acquisition cavity and enters the corresponding balloon cavity, and at the same time, a connection joint between the imaging fiber and the light guide fiber is provided at the filling port of the balloon pipeline; 所述滑块部还包括摄像对接头和导光对接头,所述摄像对接头和导光对接头位于球囊充注头的外围;在球囊管道充注口与球囊充注头对接时,摄像对接头和导光对接头也分别与摄像光纤和导光光纤的连接接头对接以进行电连接。The slider part also includes a camera docking joint and a light guide docking joint, which are located at the periphery of the balloon filling head; when the balloon tube filling port is docked with the balloon filling head, the camera docking joint and the light guide docking joint are also docked with the connecting joints of the camera optical fiber and the light guide optical fiber respectively to make an electrical connection. 9.根据权利要求6所述的快速止血球囊,其特征在于:所述充注分配器包括多维对接盘,所述多维对接盘的上平面设置前述球囊充注头,多个球囊管道充注口设置在同一平面且该平面与多维对接盘的上平面平行;所述多维对接盘包括滑动台、转动台和纵向移位器,所述滑动台、转动台和纵向移位器接收控制器的控制;所述球囊充注头通过横移机构安装在所述多维对接盘的滑动台上,所述横移机构用于驱动所述球囊充注头在滑动台上横向移动;所述滑动台安装在转动台上,所述转动台用于驱动滑动台进行旋转,从而带动球囊充注头旋转;所述转动台安装在纵向移位器上,所述纵向移位器用于驱动所述转动台在纵向上进行移动,从而带动球囊充注头与球囊管道充注口对接或者分离;当球囊充注头与球囊管道充注口分离时,流体的注入操作停止;9. The rapid hemostatic balloon according to claim 6 is characterized in that: the filling distributor includes a multidimensional docking tray, the upper plane of the multidimensional docking tray is provided with the aforementioned balloon filling head, and multiple balloon pipeline filling ports are arranged in the same plane and the plane is parallel to the upper plane of the multidimensional docking tray; the multidimensional docking tray includes a sliding table, a rotating table and a longitudinal shifter, and the sliding table, the rotating table and the longitudinal shifter are controlled by a controller; the balloon filling head is installed on the sliding table of the multidimensional docking tray through a transverse movement mechanism, and the transverse movement mechanism is used to drive the balloon filling head to move laterally on the sliding table; the sliding table is installed on the rotating table, and the rotating table is used to drive the sliding table to rotate, thereby driving the balloon filling head to rotate; the rotating table is installed on the longitudinal shifter, and the longitudinal shifter is used to drive the rotating table to move in the longitudinal direction, thereby driving the balloon filling head to dock or separate with the balloon pipeline filling port; when the balloon filling head is separated from the balloon pipeline filling port, the fluid injection operation stops; 或者,所述充注分配器包括旋转对接盘,所述旋转对接盘包括旋转段和旋转驱动结构,旋转驱动结构用于驱动旋转段旋转,多个球囊管道充注口对应着所述旋转段设置且分别位于旋转段的不同方位;所述旋转段包括输入端和输出端,所述输入端用于连接充注装置,所述旋转驱动结构能够在控制器的控制下驱动旋转段旋转以使输出端分别与不同方位的球囊管道充注口连通;当输出端与目标球囊管道充注口连通时,目标球囊的充注口控制阀打开,流体通过旋转段进入球囊管道后输入到目标球囊中。Alternatively, the filling distributor includes a rotating docking plate, which includes a rotating section and a rotating drive structure, the rotating drive structure is used to drive the rotating section to rotate, and a plurality of balloon conduit filling ports are arranged corresponding to the rotating section and are respectively located at different positions of the rotating section; the rotating section includes an input end and an output end, the input end is used to connect to the filling device, and the rotating drive structure can drive the rotating section to rotate under the control of a controller so that the output end is respectively connected to the balloon conduit filling ports in different positions; when the output end is connected to the target balloon conduit filling port, the filling port control valve of the target balloon is opened, and the fluid enters the balloon conduit through the rotating section and is then input into the target balloon. 10.一种球囊扩张系统,用于子宫腔止血,其特征在于包括:10. A balloon dilation system for uterine cavity hemostasis, characterized by comprising: 可膨胀囊体,所述可膨胀囊体为权利要求1-9中任一项所述的快速止血球囊;An expandable sac, wherein the expandable sac is a rapid hemostatic balloon according to any one of claims 1 to 9; 囊体扩张控制装置,包括面向用户的上位机,所述上位机用于显示球囊组件中的各球囊信息,在采集到用户针对其中一个或多个球囊发出的球囊充注指令后,将所述球囊充注指令发送给前述快速止血球囊的充注分配组件。The balloon expansion control device includes a user-oriented host computer, which is used to display information of each balloon in the balloon assembly. After collecting balloon filling instructions issued by the user for one or more balloons, the host computer sends the balloon filling instructions to the filling distribution assembly of the aforementioned rapid hemostasis balloon.
CN202411391675.3A 2024-10-08 2024-10-08 Rapid hemostatic balloon and system Pending CN119055310A (en)

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