Automatic device for blocking balloon

Abstract

The utility model relates to the technical field of medical instruments, and discloses an automatic device for blocking a balloon, which is used for blocking or partially blocking the blood vessel of a subject. The device comprises a balloon catheter, and a conversion part further comprises a host part. Wherein the conversion part and the host part can be in butt joint with each other in a detachable mode, and the balloon catheter can be inserted into a blood vessel and control the balloon at the far end to expand through signal transmission. The device can provide selectable operation modes for an operator, provides a balloon device which is convenient and safe to use and higher in error-tolerant rate, and is placed in an artery to reduce adverse effects on a patient caused by vascular rupture.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and particularly relates to an automatic device for blocking a balloon. Background Art

[0002] Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a surgical method, which usually implants a balloon catheter device into a blood vessel percutaneously and then inflates it to control bleeding. In the past decade, REBOA has been increasingly used to improve hemodynamic stability by increasing systolic blood pressure and controlling life-threatening bleeding before and / or during definitive surgical or endovascular interventions.

[0003] Resuscitative endovascular balloon occlusion of the aorta (REBOA) can be applied to the treatment of a variety of clinical diseases, including uncontrolled traumatic bleeding, postpartum hemorrhage, placenta accreta spectrum disorders (PAS), out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation (CPR), and non-traumatic abdominal bleeding, etc., and is usually carried out in non-surgical fields.

[0004] Since the existing technologies require fluoroscopic guidance when dealing with situations such as traumatic bleeding, non-traumatic bleeding, traumatic cardiac arrest, and non-traumatic cardiac arrest, and the operation process of large fluoroscopic instruments is too complex, and it takes too long to perform endovascular catheterization using fluoroscopy, CT, MR scanning, etc. in urgent situations with tight time, it is not the best choice. Therefore, there is an increasing demand for a portable REBOA operating system at present, mainly through a portable device, so that REBOA can be operated in hospital or non-hospital environments by users who have not received much relevant professional training. Thus, it not only allows in-hospital experts, but also non-doctors or those who only understand medical common sense to operate. Summary of the Invention

[0005] Embodiments of the present application provide an automatic device for blocking a balloon to control complete or partial occlusion of a patient's blood vessel. The REBOA host of the present application is designed into a conversion part fixedly connected to the balloon catheter and a host part with electronic control elements, and has two operation ports, allowing the operator to select manual operation or automatic operation according to the actual situation.

[0006] Embodiments of the present application disclose an automatic device for blocking a balloon, including: a balloon catheter (10), a conversion part (20), and a host part (30).

[0007] Further, the main body of the balloon catheter (10) is a catheter extending between a proximal end and a distal end, the distal end can be inserted into a blood vessel, and a balloon (101) surrounds the catheter and expands when filled with a fluid medium.

[0008] Furthermore, the balloon (101) is a compliant or semi-compliant balloon, and the material includes but is not limited to: nylon (PA), polyurethane (TPU), polyetheramide block copolymer (PEBAX), or a material formed by mixing one or more of them in a certain proportion.

[0009] Further, the conversion part (20) can be fixedly connected to the balloon catheter (10). Its main body part includes a manual operation interface (201) and / or an automatic operation interface (202), which can be used by the operator to select a suitable operation mode; it also includes a pressure converter (203), a fluid controller (204), a first electrical signal transmission port (205), a first fluid signal transmission port (206), and a purification structure (207).

[0010] Furthermore, since the manual operation and the automatic operation do not share the same interface, the two modes will not affect each other, and the operator is allowed to switch between the two operation modes during the operation, increasing the fault tolerance rate of the device.

[0011] Furthermore, the instructions for manual operation are generally defined as operation instructions that can be perceived by humans, such as visual, auditory, or tactile signals related to the operation of manually inflating the balloon (101), such as increasing or decreasing the air extraction speed or pressure. The instructions for the automatic operation mode controlled by the host (20) can be a set of computer instructions, such as computer code, representing the control of the inflation situation, such as controlling the pump (2013) to increase or decrease the air extraction speed or pressure.

[0012] Further, the host part (30) can be detachably connected to the conversion part (20). Its main body part includes a second electrical signal transmission port (301), a second fluid signal transmission port (302), an electronic controller (303), and a power structure (304).

[0013] Further, the balloon catheter (10) has two channels inside, including a pressure sensing chamber (102) for transmitting blood pressure and an inflation chamber (103) for transmitting fluid to the balloon (101).

[0014] Furthermore, the pressure sensing chamber (102) has a pressure sensing opening (1021) between the balloon (101) and the distal end, which can transmit the blood pressure to the conversion part (20).

[0015] Furthermore, the opening of the inflation chamber (103) is inside the balloon (101). After receiving the control signal, the fluid medium can be filled into the balloon (101) through the inflation opening (1031).

[0016] Further, the pressure converter (203) is located within the conversion section (20), capable of receiving a fluid signal representing the occlusion parameter, converting the fluid signal into an electrical signal, and transmitting the electrical signal to the electronic controller (303).

[0017] Furthermore, the pressure converter (203) is electrically connected inside the conversion section (20). The conversion section (20) can receive data indicating the pressure inside the balloon from the pressure converter (203) and, in the automatic operation mode, control the operation of the pump to drive or withdraw fluid from the fluid storage unit (305), thereby controlling the size of the balloon.

[0018] Furthermore, the pressure converter (203) can be a sensor capable of sensing the occlusion parameter in the blood vessel, specifically a pressure sensor, a flow sensor, or a similar sensor. The pressure converter (203) can sense and indicate the pressure of the occluded blood vessel or indicate the blood vessel flow rate to indicate the occlusion state, and further convert the value into an electrical signal for transmission through the connector.

[0019] Furthermore, the fluid controller (204) is located within the conversion section (20) and can control the filling or not of the fluid medium according to the pressure difference between the blood pressure in the pressure sensing chamber (102) and the fluid pressure in the filling chamber (103): allowing fluid to flow when the pressure difference is higher than a certain threshold, and preventing fluid from flowing when the pressure difference is lower than a certain threshold.

[0020] Furthermore, the threshold value is in the occluded blood vessel state. The fluid controller (204) can compare the signal of the blood pressure received by the sensor near the balloon with the set threshold value and control the filling degree of the balloon within an appropriate range.

[0021] Furthermore, the fluid controller (204) further includes an electric valve, and the electric valve further includes: a solenoid valve, a ball valve, a pinch valve, or a tube clamp valve, etc.

[0022] Further, the first electrical signal transmission port (205) is in the conversion section (20) and can transmit the electrical signal converted by the pressure converter (203) to the host section (30).

[0023] Further, the first fluid signal transmission port (206) is in the conversion section (20) and can transmit the fluid in the balloon catheter (10) between the conversion section (20) and the host section (30).

[0024] Further, the purification structure (207) is within the conversion section (20), and it establishes fluid communication between the main body section (30) and the balloon catheter (10) and can purify the fluid medium. The purification structure (207) includes a bubble filter, etc., which can eliminate the bubbles in the fluid medium.

[0025] Further, the second electrical signal transmission port (301) is in the main body section (30) and can receive the electrical signal converted by the pressure converter (203).

[0026] Further, the second fluid signal transmission port (302) is in the main body section (30) and can transmit the fluid in the balloon catheter (10) between the conversion section (20) and the main body section (30).

[0027] Furthermore, an electrical signal connection port (208) is formed inside the conversion section (20), which is the connection interface for the first electrical signal transmission port (205) and the second electrical signal transmission port (301). Through this interface, electrical signal transmission can be achieved; a fluid connection port is formed inside the conversion section (20), which is the connection interface for the first fluid signal transmission port (206) and the second fluid signal transmission port (302), namely the automatic operation interface (202). Through this interface, fluid communication can be achieved.

[0028] Further, there is an electronic controller (303) in the main body section (30). The electronic controller (303) receives the occlusion parameters from the pressure converter (203) and provides instructions according to the parameters to indicate the operator to use manual operation or control the automatic operation program of the device.

[0029] Further, the power structure (304) is in the main body section (30) and provides power to enable the fluid medium to be transmitted within the main body section (30), the conversion section (20), and the balloon catheter (10);

[0030] Furthermore, the power structure (304) mainly refers to a pump, including a piston pump, a peristaltic pump, or any other type of power-driven pump.

[0031] Further, there is also a fluid storage section (305) in the main body section (30) for storing the fluid medium for filling the balloon (101).

[0032] Furthermore, the device of the present application allows an external fluid storage section to be intervened so that manual operation can be used when an error occurs in the automatic operation.

[0033] Furthermore, the materials of all the connecting hoses or the fluid storage part (305) in the present application can be selected from silicone, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polypropylene (PP), polyethylene (PE), polyurethane (TPU), etc., or a material mixture of one or more of them in a certain proportion.

[0034] In the device according to the present application, the conversion part (20) and the host part (30) can be detachably connected. The advantage of this detachable connection is that it allows the two parts to be disinfected in different ways. The host part (30) with more electronic components requires different disinfection methods. The conversion part (20) can use disinfection methods with higher penetration rates, such as radiation sterilization. The host part (30) can use disinfection methods with less damage to electronic components, such as gas sterilization, plasma sterilization, etc.

[0035] The advantages of the present application are as follows: It provides an automatic device for occluding a balloon. The conversion part (20) and the host part (30) of the device are detachably connected, which can provide an operator with selectable operation modes, and provides a balloon device that is convenient to use, safe, and has a higher error tolerance rate, and is placed in an artery to reduce the adverse effects brought to patients by blood vessel rupture. Description of the Drawings

[0036] The drawings are only for the purpose of showing the preferred embodiments and should not be considered as a limitation to the present application. Moreover, throughout the drawings, the same reference numerals are used to identify the same components. In the drawings:

[0037] Figure 1 is the balloon catheter and the conversion part

[0038] Figure 2 is the distal end of the balloon catheter

[0039] Figure 3 is the conversion part

[0040] Figure 4 is the host part

[0041] Figure 5 is the overall schematic diagram of the machine.

[0042] Description of the Reference Numerals in the Drawings:

[0043] 10: Balloon catheter; 101: Balloon; 102: Pressure sensing cavity; 1021: Pressure sensing opening; 103: Filling cavity; 1031: Filling opening; 20: Conversion part; 201: Manual operation interface; 202: Automatic operation interface; 203: Pressure converter; 204: Fluid controller; 205: First electrical signal transmission port; 206: First fluid signal transmission port; 207: Purification structure; 208: Electrical signal connection port; 30: Host part; 301: Second electrical signal transmission port; 302: Second fluid signal transmission port; 303: Electronic controller; 304: Power structure; 305: Fluid storage part. Detailed implementation manners

[0044] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0045] It should be understood that the terms used herein are for the purpose of describing specific exemplary embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "include", "comprise", "contain", and "have" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring the specific order of execution as described or illustrated, unless the order of execution is explicitly stated. It should also be understood that additional or alternative steps may be used.

[0046] Although the terms first, second, third, etc. may be used in the text to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first" and "second" and other numerical terms used in the text do not imply an order or sequence. Therefore, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0047] For ease of description, spatial relative relationship terms may be used in this text to describe the relationship of one element or feature shown in the figure with respect to another element or feature. These relative relationship terms are, for example, "inner", "outer", "inner side", "outer side", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device during use or operation other than the orientations depicted in the figure. For example, if the device in the figure is flipped, an element described as "below" or "beneath" another element or feature will then be oriented as "above" or "over" the other element or feature. Thus, the exemplary term "below" can include both the upper and lower orientations. The device may be oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used in this text are accordingly interpreted.

[0048] In the description of the present utility model, unless otherwise clearly specified and defined, the terms "mounted", "connected", "connected to", "fixed" shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be a direct connection or an indirect connection through an intermediate medium, and it may be the communication inside two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances. In the field of interventional medical devices, generally, the end of a medical device implanted into the human body or an animal body that is closer to the operator is called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any part of the medical device are defined based on this principle.

[0049] An automatic device for occluding a balloon, as Figures 1 to 5 shown, comprising: a balloon catheter (10); a balloon (101); a pressure sensing chamber (102); a pressure sensing opening (1021); a filling chamber (103); a filling opening (1031); a conversion part (20); a manual operation interface (201); an automatic operation interface (202); a pressure converter (203); a fluid controller (204); a first electrical signal transmission port (205); a first fluid signal transmission port (206); a purification structure (207); an electrical signal connection port (208); a host part (30); a second electrical signal transmission port (301); a second fluid signal transmission port (302); an electronic controller (303); a power structure (304); a fluid storage part (305).

[0050] As Figures 1 to 2As shown, the device includes: a balloon catheter (10) and a main unit (20). Among them, the balloon catheter (10) is connected to the main unit (20), extends between a proximal end and a distal end, and the distal end can be inserted into a blood vessel. The balloon (101) surrounds the slender catheter and expands when receiving a fluid medium from an inflation device. The fluid medium can be gaseous or viscous. A liquid fluid medium (such as normal saline) can obtain the most reliable pressure to achieve occlusion of the aorta. The balloon catheter (10) has at least two channels. One channel, namely the filling channel (103), can enable fluid to fill the balloon (101), and the other channel, namely the pressure sensing channel (102), can allow blood to flow through via a pressure sensing opening (1021) at the distal end and enable the system to monitor blood pressure. The balloon (101) is a compliant or semi-compliant balloon, and the material includes but is not limited to: one or more of nylon (PA), polyurethane (TPU), and polyetheramide block copolymer (PEBAX) mixed in a certain proportion.

[0051] In Figure 3 In the illustrated embodiment, inside the conversion part (20), there is a pressure converter (203) that can receive fluid signals transmitted from the pressure sensing channel (102) and the filling channel (103) in the balloon catheter (10). The fluid signals can indicate the pressure in the occluded blood vessel and the filling pressure in the balloon (101). Further, the pressure converter (203) converts the fluid signals into electrical signals and transmits the electrical signals through a first electrical signal transmission port (205).

[0052] Inside the conversion part (20), there is also a fluid controller (204) that can be used to control based on the difference between the pressures in the pressure sensing channel (102) and the filling channel (103). When the pressure difference is higher than a certain threshold, it allows the fluid in the filling channel (103) to flow; when the pressure difference is lower than a certain threshold, it blocks the fluid in the filling channel (103) from flowing. The fluid controller (204) may also include an electric valve, and the electric valve also includes: a solenoid valve, a ball valve, a pinch valve, or a tube clamp valve, etc.

[0053] Inside the conversion part (20), there is also a purification structure (207), which can be a bubble filter, capable of reducing the possibility of generating bubbles inside the balloon (101) entering the body and during the transmission of the fluid medium, ensuring the safety of the device.

[0054] In Figure 5In the illustrated embodiment, the conversion part (20) and the host part (30) are detachably connected to each other. Among them, the first electrical signal transmission port (205) is connected to the second electrical signal transmission port (301) to form an electrical signal connection port (208); the first fluid signal transmission port (206) is connected to the second fluid signal transmission port (302) to form a fluid connection port. The electrical signal connection port (208) transmits the electrical signal output by the pressure converter (203) into the electronic controller (303) in the host part (30), and provides a set of instructions for manual or automatic inflation based on the electrical signal.

[0055] In Figures 1 to 5 In the illustrated embodiment, the device has a manual operation interface (201) and an automatic operation interface (202), and can analyze whether to use manual operation or automatic operation according to the actual situation. Manual operation can be accessed to an external filling device through the manual operation interface (201), and it can also be used when the automatic operation fails, when the operator prefers to use manual operation, or when verifying the balloon state before the implementation of the REBOA technique. When in automatic operation, the filling device can be connected to the automatic operation interface (208). In this mode, the operation can be under the control of the device and is also more secure. The manual operation interface (201) and the automatic operation interface (202) are not interconnected, which allows the operator to switch between the manual mode and the automatic mode during the operation, providing a higher fault tolerance rate.

[0056] As described above, it is only a preferred specific embodiment of the present application, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. An automatic device for blocking a balloon, characterized in that: The device comprises: A balloon catheter (10), a conversion part (20) and a host part (30); The main body of the balloon catheter (10) is a catheter extending between a proximal end and a distal end, wherein the distal end can be inserted into a blood vessel, and a balloon (101) surrounds the catheter and expands when filled with a fluid medium; The conversion part (20) can be fixedly connected to the balloon catheter (10), and its main body includes a manual operation interface (201) and / or an automatic operation interface (202) for an operator to select a suitable operation mode; it also includes a pressure converter (203), a fluid controller (204), a first electrical signal transmission port (205), a first fluid signal transmission port (206) and a purification structure (207); The host part (30) can be detachably connected to the conversion part (20), and its main body part comprises a second electrical signal transmission port (301), a second fluid signal transmission port (302), an electronic controller (303), and a power structure (304).

2. The device according to claim 1, characterized in that: The balloon catheter (10) has two cavities inside, including a pressure sensing cavity (102) for transmitting blood pressure and a filling cavity (103) for transmitting fluid to the balloon (101); in, The pressure sensing chamber (102) has a pressure sensing opening (1021) between the balloon (101) and the distal end, which can transmit blood pressure to the conversion part (20); The opening of the filling chamber (103) is inside the balloon (101), and after receiving a control signal, the fluid medium can be filled into the balloon (101) through the filling opening (1031).

3. The device according to claim 1, characterized in that: The pressure converter (203) is located in the conversion part (20), and is capable of receiving a fluid signal representing an occlusion parameter, converting the fluid signal into an electrical signal, and transmitting the electrical signal to the electronic controller (303).

4. The device according to claim 2, characterized in that: The fluid controller (204) is located in the conversion part (20), and can control whether the fluid medium is filled or not according to the pressure difference between the blood pressure in the pressure sensing chamber (102) and the fluid pressure in the filling chamber (103): when the pressure difference is higher than a certain threshold value, the fluid is allowed to flow, and when the pressure difference is lower than the certain threshold value, the fluid is prevented from flowing; The fluid controller (204) further comprises an electric valve, and the electric valve further comprises: a solenoid valve, a ball valve, a pipe clamp valve or a pipe clamp valve.

5. The device according to claim 1, characterized in that: The first electrical signal transmission port (205) is in the conversion part (20) and is capable of transmitting the electrical signal converted by the pressure converter (203) to the host part (30); The first fluid signal transmission port (206) is in the conversion part (20) and is capable of transmitting the fluid in the balloon catheter (10) between the conversion part (20) and the host part (30).

6. The device according to claim 1, characterized in that: The purification structure (207) is inside the conversion part (20) and establishes fluid communication between the host part (30) and the balloon catheter (10) and can purify the fluid medium. The purification structure (207) includes a bubble filter that can eliminate bubbles in the fluid medium.

7. The device according to claim 1, characterized in that: The second electrical signal transmission port (301) is in the host part (30) and is capable of receiving the electrical signal converted by the pressure converter (203); The second fluid signal transmission port (302) is in the main unit part (30) and is capable of transmitting the fluid in the balloon catheter (10) between the conversion part (20) and the main unit part (30).

8. The device according to claim 1, characterized in that: An electrical signal connection port (208) is formed inside the conversion part (20), which is a connection interface between the first electrical signal transmission port (205) and the second electrical signal transmission port (301), through which electrical signal transmission can be achieved; a fluid connection port is formed inside the conversion part (20), which is a connection interface between the first fluid signal transmission port (206) and the second fluid signal transmission port (302), that is, an automatic operation interface (202), through which fluid communication can be achieved.

9. The device according to claim 1, characterized in that: The power structure (304) is in the main unit part (30) and provides power to transmit the fluid medium within the main unit part (30), the conversion part (20) and the balloon catheter (10); the power structure (304) mainly refers to a pump, including a piston pump, a peristaltic pump or any other type of power-driven pump.

10. The device according to claim 1, characterized in that: The main body part (30) also has a fluid storage section (305) for storing the fluid medium that fills the balloon (101).

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