Balloon catheter system capable of automatically regulating and supplementing pressure

By designing an automatic pressure-regulating and pressure-compensating balloon catheter system, the problem of the inability of balloon catheters to automatically regulate pressure was solved, achieving stable control of the pressure inside the balloon, reducing pressure on the airway mucosa, maintaining blood circulation, and avoiding the risk of ischemic necrosis and infection.

CN224141345UActive Publication Date: 2026-04-21JIANGSU CHANGMEI MEDICAL INSTR CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
JIANGSU CHANGMEI MEDICAL INSTR CO LTD
Filing Date
2024-12-30
Publication Date
2026-04-21

AI Technical Summary

Technical Problem

Existing balloon catheter systems cannot automatically adjust and replenish pressure, which leads to obstructed blood circulation in the airway mucosa, easily causing ischemia, necrosis, and infection.

Method used

A balloon catheter system comprising an endotracheal balloon catheter, a reservoir balloon, and a two-way valve was designed. Equipped with a pressure regulating and compensating valve, the system automatically adjusts the pressure inside the balloon to maintain the set value by adjusting the knob, thus avoiding excessively high or low balloon pressure.

Benefits of technology

The balloon catheter automatically adjusts when the set pressure value is reached, reducing pressure on the airway mucosa, maintaining blood supply, and avoiding the risk of ischemic necrosis and infection.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model relates to a balloon catheter system capable of automatically regulating and supplementing pressure, which comprises a tracheal balloon catheter, an air storage balloon and a two-way valve, the air storage balloon is communicated with the tracheal balloon catheter through an air inlet pipe, and the two-way valve is arranged on an air inlet pipeline; and the pressure regulating and supplementing valve is arranged on the air inlet pipeline, and the pressure regulating and supplementing valve is automatically opened to inflate the tracheal balloon catheter, so that the pressure of the tracheal balloon catheter is maintained at a set value. The problem that a balloon catheter system cannot automatically adjust and supplement pressure is solved.
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Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a balloon catheter system with automatic pressure adjustment and replenishment. Background Technology

[0002] Patients under general anesthesia or in the ICU need to have an endotracheal balloon catheter placed in the trachea through the mouth or nose, and are assisted with breathing by an anesthesia machine or ventilator. During ventilation, there is a balloon at the distal end of the endotracheal balloon catheter. In order to ensure ventilation seal, an appropriate amount of gas is inflated into the balloon, and the inflation pressure will be higher than the pressure during mechanical ventilation.

[0003] When a balloon compresses the airway mucosa, blood circulation is obstructed, blood supply is reduced, or even eliminated. If the balloon compresses the airway mucosa for a short period, it deflates, and blood circulation resumes after the pressure is relieved, leaving the compressed area unharmed. However, prolonged compression can cause mild ischemia and necrosis at the site of airway mucosa compression, easily leading to airway infection, cough, or even lung infection.

[0004] To mitigate the aforementioned negative impacts, commonly used clinical solutions include:

[0005] 1. When inflating the endotracheal balloon catheter, precise operation is required. Inflation should be done using a pressure gauge, generally at 30 mmHg. However, in patients with poor lung compliance, the inflation pressure may need to be appropriately increased. This method avoids excessively high balloon inflation pressure, minimizes pressure on the airway mucosa from the sealed balloon, and prolongs the time the airway mucosa can withstand pressure. However, in patients requiring prolonged mechanical ventilation, ischemic necrosis can still occur.

[0006] II. In patients undergoing endotracheal intubation and mechanical ventilation, the balloon is periodically deflated to temporarily restore blood circulation to the airway mucosa. This method requires significant manual intervention from nursing staff, and during balloon deflating, severe air leakage occurs, affecting ventilation efficiency, oxygenation, and potentially causing hypoxia. There is an urgent clinical need for a simple device that maintains blood supply to the area compressed by the balloon while ensuring a tight seal during mechanical ventilation. Similar situations exist when balloon catheters are inserted into other body cavities, which will not be elaborated upon here. Utility Model Content

[0007] The technical problem to be solved by this utility model is to overcome the shortcomings of the prior art and provide a balloon catheter system that can automatically adjust and replenish pressure, thereby solving the technical problem that previous balloon catheter systems could not automatically adjust and replenish pressure, resulting in compression of the blood supply to the inner wall of the airway.

[0008] The technical solution adopted by this utility model to solve its technical problem is:

[0009] First aspect:

[0010] A balloon catheter system with automatic pressure adjustment and replenishment is provided, including...

[0011] The endotracheal balloon catheter, the reservoir balloon, and the two-way valve are provided. The reservoir balloon and the endotracheal balloon catheter are connected by an air inlet tube, and the two-way valve is installed on the air inlet tube.

[0012] A pressure regulating and replenishing valve is installed on the air inlet pipe. The pressure regulating and replenishing valve automatically opens to inflate the endotracheal balloon catheter, thereby maintaining the pressure of the endotracheal balloon catheter at a set value.

[0013] Furthermore, the pressure regulating and compensating valve includes

[0014] The valve body has an inlet chamber, an outlet chamber, a diaphragm chamber, a rod chamber, and a bottom chamber. The rod chamber connects the diaphragm chamber, the outlet chamber, and the bottom chamber, and the bottom chamber connects the inlet chamber and the outlet chamber.

[0015] A valve bottom cover is provided at the lower end of the valve body and is sealed to the bottom cavity, and a sealing gasket is provided inside the bottom cavity;

[0016] A valve top cover is provided on the upper end of the valve body and is sealed to the diaphragm cavity. A diaphragm is provided in the diaphragm cavity and the diaphragm is sealed and clamped between the valve top cover and the valve body. An adjustment knob is provided on the upper end of the valve top cover.

[0017] The valve core includes a valve stem and a core plate. The core plate is located in the bottom cavity. The lower end of the valve stem extends into the bottom cavity and is fixedly connected to the core plate. The upper end of the valve stem passes through the air outlet cavity and enters the diaphragm cavity. The upper end of the valve stem passes through the diaphragm, and a sealing fit is made between the valve stem and the diaphragm. A spring is provided between the upper end of the valve stem and the adjustment knob. The sealing gasket is located above the core plate, and the valve stem passes through the sealing gasket. When the pressure in the endotracheal balloon catheter is at a set value, the valve core moves upward and drives the sealing gasket to seal the air inlet outlet.

[0018] Furthermore, a groove is formed on the valve stem, and the diaphragm is located inside the groove, forming a sealing fit between the diaphragm and the inner wall of the groove.

[0019] Furthermore, a positioning groove is provided at the lower end of the adjustment knob, and the upper end of the spring extends into the positioning groove.

[0020] Furthermore, a positioning cone is formed at the upper end of the valve stem, and the positioning cone cooperates with the lower end of the spring.

[0021] Furthermore, a spacer is provided in the positioning groove, and the spacer is disposed between the upper end of the spring and the positioning groove.

[0022] Furthermore, an indicator pressure airbag is provided on the air intake pipe.

[0023] The second aspect:

[0024] A method of using the above-described balloon catheter system is provided, characterized in that:

[0025] Set the working pressure of the pressure regulating and pressure-compensating valve to the predetermined pressure by rotating the adjustment knob;

[0026] Place the balloon of the endotracheal balloon catheter into the human airway, open the two-way valve, and the storage balloon will inflate the balloon. When the pressure inside the balloon rises to the set value, the diaphragm will move the valve core upward, thereby sealing the air inlet outlet and preventing excessive pressure from being input into the balloon.

[0027] When the pressure inside the balloon is lower than the set value, the diaphragm moves the valve core downward, connecting the air outlet chamber and the air inlet chamber, and the storage balloon inflates the balloon until the pressure inside the balloon rises to the set value.

[0028] The beneficial effects of this utility model are: The balloon catheter system of this utility model adopts a newly designed pressure regulating and replenishing valve, which can automatically close the tracheal balloon catheter when it reaches the set pressure value, and automatically open the pressure regulating and replenishing valve when the pressure inside the tracheal balloon catheter is lower than the pressure value, relying on the storage balloon to automatically inflate the tracheal balloon catheter to the set value. Attached Figure Description

[0029] The present invention will be further described below with reference to the accompanying drawings.

[0030] Figure 1 This utility model relates to a balloon catheter system.

[0031] Figure 2 and Figure 3 This is a schematic diagram of a pressure regulating and pressure-compensating valve;

[0032] Figure 4 This is a schematic diagram of the valve body;

[0033] Figure 5 This is a schematic diagram of the valve core;

[0034] Among them, 1. endotracheal balloon catheter, 11. balloon body;

[0035] 21. Gas storage bladder; 22. Two-way valve; 23. Pressure indicator bladder;

[0036] 3. Valve body; 31. Inlet chamber; 32. Outlet chamber; 33. Diaphragm chamber; 34. Rod chamber; 35. Bottom chamber;

[0037] 4. Valve core; 41. Valve stem; 42. Core plate; 43. Slot; 44. Positioning cone;

[0038] 51. Valve bottom cover; 52. Valve top cover; 53. Adjusting knob; 54. Spacer; 55. Spring; 61. Sealing gasket; 62. Diaphragm. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0040] This application provides a balloon catheter system with automatic pressure adjustment and replenishment, which will be described in detail below. It should be noted that the order of description of the following embodiments is not intended to limit the preferred order of the embodiments of this application. Furthermore, the descriptions of each embodiment have their own emphasis; parts not described in detail in a certain embodiment can be referred to in the relevant descriptions of other embodiments.

[0041] To address the technical problem in existing balloon catheter systems that cannot automatically adjust and replenish pressure, thus causing compression of the blood supply to the airway wall, one embodiment of this application provides a balloon catheter system with automatic pressure adjustment and replenishment. This is described in detail below.

[0042] like Figure 1 As shown, an automatically adjustable and pressure-compensating balloon catheter system includes...

[0043] The endotracheal balloon catheter 1, the reservoir balloon 21, and the two-way valve 22 are provided. The reservoir balloon 21 and the endotracheal balloon catheter 1 are connected by an air inlet tube. The two-way valve 22 is installed on the air inlet tube.

[0044] A pressure regulating and pressure replenishing valve is installed on the air inlet pipe. The pressure regulating and pressure replenishing valve automatically opens to inflate the endotracheal balloon catheter 1, thereby maintaining the pressure of the endotracheal balloon catheter 1 at a set value.

[0045] Specifically, as an optional implementation method in this embodiment, such as Figures 2 to 5 As shown, the pressure regulating and pressure-compensating valve includes

[0046] The valve body 3 has an inlet chamber 31, an outlet chamber 32, a diaphragm chamber 33, a rod chamber 34, and a bottom chamber 35. The rod chamber 34 connects the diaphragm chamber 33, the outlet chamber 32, and the bottom chamber 35. The bottom chamber 35 connects the inlet chamber 31 and the outlet chamber 32.

[0047] Valve bottom cover 51 is located at the lower end of valve body 3 and is sealed to bottom cavity 35. A sealing gasket 61 is provided inside bottom cavity 35.

[0048] A valve top cover 52 is disposed on the upper end of the valve body 3 and is sealed to the diaphragm cavity 33. A diaphragm 62 is disposed inside the diaphragm cavity 33. The diaphragm 62 is sealed and clamped between the valve top cover 52 and the valve body 3. An adjustment knob 53 is disposed on the upper end of the valve top cover 52.

[0049] The valve core 4 includes a valve stem 41 and a core plate 42. The core plate 42 is located in the bottom cavity 35. The lower end of the valve stem 41 extends into the bottom cavity 35 and is fixedly connected to the core plate 42. The upper end of the valve stem 41 passes through the air outlet cavity 32 and enters the diaphragm cavity 33. The upper end of the valve stem 41 passes through the diaphragm 62, and the valve stem 41 and the diaphragm 62 are sealed together. A spring 55 is provided between the upper end of the valve stem 41 and the adjusting knob 53. The sealing gasket 61 is located above the core plate 42, and the valve stem 41 passes through the sealing gasket 61. When the pressure in the endotracheal balloon catheter 1 is at a set value, the valve core 4 moves upward and drives the sealing gasket 61 to seal the outlet of the air inlet cavity 31.

[0050] In this embodiment, as Figure 1 As shown, an indicator pressure airbag 23 is provided on the air inlet tube. The function of the indicator pressure airbag is to allow the user to visually see or touch the gas pressure in the endotracheal balloon catheter from outside the body, since the section of the endotracheal balloon catheter inserted into the body is not visible. Now, the pressure of the balloon body can be seen or touched very directly.

[0051] In this embodiment, as Figure 3 As shown, a convex ring is formed at the outlet of the air intake chamber 31. The convex ring protrudes into the bottom cavity 35. The outlet of the air intake chamber 31 cooperates with the sealing gasket 61 through the convex ring, which facilitates the sealing performance of the sealing gasket 61 at the outlet of the air intake chamber 31.

[0052] In this embodiment, the diaphragm 62 is made of silicone, which falls within the scope of existing technology.

[0053] After the diaphragm 62 is connected to the valve stem 41, the valve stem 41 can move up and down with the diaphragm 62.

[0054] The diaphragm 62 moves up and down as the air pressure inside the valve body 3 changes. When the air pressure is at the set value, the diaphragm 62 bulges upward and drives the valve stem 41 to move upward, thereby causing the sealing gasket 61 to close the outlet of the air inlet chamber 31. When the air pressure is lower than the set value, the diaphragm 62 moves downward, thereby driving the valve stem 41 to move downward, and the outlet of the air inlet chamber 31 opens.

[0055] A circular stepped surface is provided inside the diaphragm cavity 33. The diaphragm 62 rests on the circular stepped surface around its perimeter. When the valve top cover 52 is connected to the valve body 3, the diaphragm 62 is pressed tightly.

[0056] Specifically, as an optional implementation method in this embodiment, such as Figure 5 As shown, a groove 43 is formed on the valve stem 41, and the diaphragm 62 is located in the groove 43, forming a sealing fit between the diaphragm 62 and the inner wall of the groove 43.

[0057] The diaphragm 62 is fitted into the groove 43 of the valve stem 41, enabling a quick connection between the diaphragm 62 and the valve stem 41.

[0058] Specifically, as an optional implementation method in this embodiment, such as Figure 5 As shown, the lower end of the adjustment knob 53 has a positioning groove, and the upper end of the spring 55 extends into the positioning groove.

[0059] The upper end of the adjustment knob 53 is provided with a cross groove, which is used to engage with a cross wrench to facilitate the rotation of the adjustment knob 53. When the positioning groove engages with the spring 55, it improves the stability between the spring 55 and the adjustment knob 53.

[0060] In this embodiment, a spacer 54 is provided in the positioning groove, and the spacer 54 is disposed between the upper end of the spring 55 and the positioning groove. The spacer 54 is designed mainly to prevent the end of the spring 55 from getting stuck with the adjustment knob 53, thus affecting the rotation of the adjustment knob 53. The spacer 54 avoids the spring 55 from directly contacting the adjustment knob 53.

[0061] Specifically, as an optional implementation method in this embodiment, such as Figure 5 As shown, a positioning cone 44 is formed at the upper end of the valve stem 41, and the positioning cone 44 cooperates with the lower end of the spring 55.

[0062] The purpose of the positioning cone 44 is to improve the stability of the assembly between the elasticity and the valve stem 41.

[0063] Working principle of pressure regulating and pressure compensating valve: The spring 55 is compressed by adjusting knob 53. The setting value of pressure regulating and pressure compensating valve is determined by the amount of compression of spring 55. When the adjustment knob 53 causes the spring 55 to deform more, the setting value of the entire pressure regulating and pressure compensating valve is higher. When the spring 55 deforms less, the setting value of pressure regulating and pressure compensating valve is lower.

[0064] The valve stem 41 moves up and down, and is subjected to the force of the spring 55 and the force of the diaphragm 62. The air pressure inside the valve causes the diaphragm 62 to bulge upward. The deformation force of the diaphragm 62 is greater than the elastic force, which naturally drives the valve stem 41 to move upward, thereby driving the core plate 42 and the sealing gasket 61 to seal the outlet of the air inlet chamber 31.

[0065] A method of using the above-mentioned balloon catheter system is provided, wherein the working pressure of the pressure regulating and pressure supplementing valve is set to a predetermined pressure of 30 mmHg by rotating the adjusting knob 53;

[0066] The gas storage balloon 21 carries gas at a pressure of 760 mmHg (≈1 atm) to meet the function of replenishing gas.

[0067] The balloon body 11 of the endotracheal balloon catheter 1 is placed in the human airway. The two-way valve 22 is opened, and the storage balloon 21 causes the balloon body 11 to inflate. When the pressure inside the balloon body 11 rises to 30 mmHg, the diaphragm 62 causes the valve core 4 to move upward, thereby sealing the outlet of the inlet chamber 31 with the sealing gasket 61, preventing further gas delivery into the balloon body 11. At this time, the pressure in the balloon body 11 and the outlet chamber 32 is 30 mmHg.

[0068] When the pressure inside the balloon 11 is lower than 30 mmHg, the diaphragm 62 moves the valve core 4 downward, the air outlet chamber 32 connects with the air inlet chamber 31, and the storage balloon 21 inflates the balloon 11 until the pressure inside the balloon 11 rises to 30 mmHg.

[0069] After the balloon body 11 blocks the airway, oxygen is supplied through another channel in the tracheobronchial balloon catheter 1.

[0070] All the devices (parts whose specific structures are not specified) selected in this application are general standard parts or parts known to those skilled in the art. Their structures and principles can be learned by those skilled in the art through technical manuals or conventional experimental methods.

[0071] In the description of the embodiments of this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0072] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0073] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. Furthermore, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Additionally, the shown or discussed mutual couplings, direct couplings, or communication connections may be through some communication interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0074] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0075] Furthermore, in the various embodiments of this utility model, the functional units can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. Based on the above-described preferred embodiments of this utility model, and through the above description, those skilled in the art can make various changes and modifications without departing from the technical concept of this utility model. The technical scope of this utility model is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A self-regulating pressure compensating balloon catheter system, characterized by, include The endotracheal balloon catheter (1), the reservoir balloon (21), and the two-way valve (22) are connected to the endotracheal balloon catheter (1) through an air inlet tube, and the two-way valve (22) is installed on the air inlet tube. A pressure regulating and pressure replenishing valve is installed on the air inlet pipe. The pressure regulating and pressure replenishing valve automatically opens to inflate the tracheal balloon catheter (1), thereby maintaining the pressure of the tracheal balloon catheter (1) at the set value.

2. The balloon catheter system with automatic pressure adjustment and replenishment according to claim 1, characterized in that, The pressure regulating and pressure replenishing valve includes The valve body (3) has an inlet chamber (31), an outlet chamber (32), a diaphragm chamber (33), a rod chamber (34), and a bottom chamber (35). The rod chamber (34) connects the diaphragm chamber (33), the outlet chamber (32), and the bottom chamber (35). The bottom chamber (35) connects the inlet chamber (31) and the outlet chamber (32). Valve bottom cover (51) is located at the lower end of valve body (3) and is sealed to bottom cavity (35). A sealing gasket (61) is provided inside bottom cavity (35). A valve top cover (52) is provided on the upper end of the valve body (3) and is sealed to the diaphragm cavity (33). A diaphragm (62) is provided in the diaphragm cavity (33). The diaphragm (62) is sealed and clamped between the valve top cover (52) and the valve body (3) on all sides. An adjustment knob (53) is provided on the upper end of the valve top cover (52). The valve core (4) includes a valve stem (41) and a core plate (42). The core plate (42) is located in the bottom cavity (35). The lower end of the valve stem (41) extends into the bottom cavity (35) and is fixedly connected to the core plate (42). The upper end of the valve stem (41) passes through the air outlet cavity (32) and enters the diaphragm cavity (33). The upper end of the valve stem (41) passes through the diaphragm (62). The valve stem (41) and the diaphragm (62) are sealed together. A spring (55) is provided between the upper end of the valve stem (41) and the adjusting knob (53). The sealing gasket (61) is located above the core plate (42), and the valve stem (41) passes through the sealing gasket (61). When the pressure in the endotracheal balloon catheter (1) is at the set value, the valve core (4) moves upward and drives the sealing gasket (61) to seal the outlet of the air inlet cavity (31).

3. The balloon catheter system with automatic pressure adjustment and replenishment according to claim 2, characterized in that, A groove (43) is formed on the valve stem (41), and the diaphragm (62) is located in the groove (43). The diaphragm (62) and the inner wall of the groove (43) form a sealing fit.

4. The balloon catheter system with automatic pressure adjustment and replenishment according to claim 2, characterized in that, The lower end of the adjustment knob (53) has a positioning groove, and the upper end of the spring (55) extends into the positioning groove.

5. The balloon catheter system with automatic pressure adjustment and replenishment according to claim 4, characterized in that, The upper end of the valve stem (41) forms a positioning cone (44), which engages with the lower end of the spring (55).

6. The self-regulating pressure compensating balloon catheter system of claim 4, wherein, a spacer (54) is arranged in the positioning groove, and the spacer (54) is arranged between the upper end of the spring (55) and the positioning groove.

7. The balloon catheter system with automatic pressure adjustment and replenishment according to claim 2, characterized in that, a pressure indicating balloon (23) is arranged on the air inlet pipe.