Low-pressure double-balloon non-slip tracheal cannula

Abstract

We provide a low-pressure double-balloon, non-slip tracheal cannula that allows for rapid removal of secretions, has a simple structure and good practicality, and is suitable for clinical airway management. [Solution] The low-pressure double-balloon anti-slip tracheal cannula according to the present invention has a main catheter 01, one end of the main catheter is the insertion end and the other end is the exposed end, and two independent balloons 02 and 03 are provided spaced apart along the axial direction on the outer peripheral wall, the first balloon 03 is closer to the insertion end and the second balloon 02 is located on the side farther from the insertion end, and the two balloons are connected to independent inflation tubes 08 and 09 respectively. On the side wall of the main catheter, a drain port and a lavage port are provided in the area corresponding to the space between the two balloons, and a drain pipe 06 and a lavage pipe 07 are provided inside, communicating with the drain port and lavage port, respectively.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a low-pressure double-balloon anti-slip tracheal cannula.

Background Art

[0002] Tracheal cannulas and tracheal intubations are important medical devices used clinically for the formation of artificial airways and the ventilation assistance of patients, and are widely applied to severe dyspnea, laryngeal surgery, emergency airway formation, etc.

[0003] In the current technology, an ordinary tracheal catheter or tracheal intubation achieves sealing and fixation by the balloon expanding and adhering to the tracheal wall according to the design of a single balloon. However, such a design has obvious defects. On the one hand, in order to ensure the fixation effect and airway sealing, the balloon needs to maintain a high inflation pressure, which causes ischemia, necrosis, edema or infection of the tracheal mucosa due to long-term pressurization, seriously threatening the safety of patients. In addition, if the pressure is reduced to protect the mucosa, problems such as air leakage and cannula detachment are likely to occur, and the stability of ventilation cannot be guaranteed. On the other hand, when a single balloon adheres to the tracheal wall, it is easy to form a dead space from the upper part of the balloon to near the epiglottis, making it easy for sputum, secretions, etc. to accumulate, forming a new source of infection and increasing the risk of lung infection in patients. In addition, clinically, the removal of secretions at this site requires the use of a special suction tube for operation, the procedure is complex, and complete removal is difficult.

[0004] Moreover, in the existing design of multiple balloons, multiple balloons may be controlled using the same inflation path. As a result, the area receiving force becomes large, but the state of each balloon cannot be adjusted independently according to clinical requirements, and it is still difficult to achieve the balance among the sealing effect, fixation stability, and mucosa protection, leaving room for improving the flexibility and safety of use.

[0005] Furthermore, existing double-balloon airway guides typically have smooth balloon surfaces, making them prone to minute movement within the airway. Additionally, they struggle to simultaneously achieve airtightness and low pressure, further increasing the risks in clinical applications and failing to meet the requirements for precise airway management. [Overview of the project] [Problems that the invention aims to solve]

[0006] In view of the above, this invention proposes a low-pressure double-balloon type non-slip tracheal cannula, aiming to solve the problem of difficulty in achieving a balance between sealing effect, fixation stability, and mucosal protection. [Means for solving the problem]

[0007] The low-pressure double-balloon anti-slip tracheal cannula according to the present invention has a main catheter, one end of which is an insertion end and the other end is an exposed end, and two independent balloons are spaced apart along the axial direction on the outer circumferential wall of the main catheter, which are a first balloon and a second balloon, respectively, with the first balloon located on one side of the first balloon, approaching the insertion end of the main catheter and the second balloon located away from the insertion end, and the first balloon and the second balloon each connecting independent inflation tubes; a drain port and a wash port are provided on the side wall of the main catheter in corresponding areas between the first balloon and the second balloon, with the drain port and the wash port spaced apart along the circumferential direction of the main catheter; an annular groove is provided on the outer circumferential wall of the first balloon and point-like protrusions are provided on the outer circumferential wall of the second balloon.

[0008] As a further technical measure, the axial distance between the first balloon and the second balloon is 1 to 3 cm.

[0009] As a further technical measure, both the first balloon and the second balloon have an annular structure, and the first balloon and the second balloon are independent cavities, with the interiors of the cavities not communicating with each other.

[0010] As a further technical measure, both the inflation tube of the first balloon and the inflation tube of the second balloon extend along the tube wall of the main catheter, and their outer ends protrude from the side wall of the exposed end of the main catheter.

[0011] As a further technical measure, each of the protruding ends of the aforementioned filling tubes is provided with an independent control valve.

[0012] As a further technical measure, a drainage tube and a irrigation tube are provided inside the main catheter along its longitudinal direction, with one end of the drainage tube communicating with the drainage port and the other end extending and protruding from the exposed end of the main catheter; and one end of the irrigation tube communicating with the irrigation port and the other end extending and protruding from the exposed end of the main catheter.

[0013] As a further technical measure, the outer diameter of the second balloon after inflation is equal to the outer diameter of the first balloon after inflation. [Effects of the Invention]

[0014] This invention has the following beneficial effects compared to existing technology. 1. By installing two independent balloons and adjusting the state of each balloon through independent inflation tubes, it eliminates the need to maintain high pressure to simultaneously secure and seal the device. This effectively reduces localized pressurization of the tracheal mucosa by a single balloon, lowering the risk of complications such as ischemia, necrosis, and edema, and improving patient comfort and long-term safety.

[0015] 2. By arranging two balloons at intervals along the axial direction of the main catheter to form a double physical fixation structure, and by combining this with an anti-slip design on the outer circumference of the balloons, the stability of the adhesion between the catheter and the tracheal wall is greatly enhanced, effectively preventing catheter detachment or air leakage due to patient movement, changes in body position, or pressure adjustments, and ensuring continuity of ventilation.

[0016] 3. By optimizing the overall structure based on the proven design of existing tracheal cannulas and adding only an independent balloon and its corresponding tubing, the functionality is enhanced, and it has the advantages of a proven manufacturing process, manageable costs, and easy clinical application. [Brief explanation of the drawing]

[0017] A detailed description of the following preferred embodiments will reveal to those skilled in the art various other advantages and beneficial effects. The drawings are used solely to illustrate preferred embodiments and are not intended to limit the scope of the present invention. In addition, throughout the drawings, the same reference numerals represent the same parts. [Figure 1] Figure 1 is a three-dimensional diagram of a low-pressure double-balloon anti-slip tracheal cannula according to one embodiment of the present invention. [Figure 2] Figure 2 is a diagram showing the positional relationship of the balloons in a low-pressure double-balloon anti-slip tracheal cannula according to one embodiment of the present invention. [Figure 3] Figure 3 is a partial structural diagram of a low-pressure double-balloon anti-slip tracheal cannula according to one embodiment of the present invention. [Figure 4] Figure 4 is a partial structural diagram of a low-pressure double-balloon type non-slip tracheal cannula according to one embodiment of the present invention. Forms for implementing a utility model

[0018] We will now describe in detail specific embodiments of the present invention in combination with the drawings. The following embodiments are for illustrative purposes only and do not limit the scope of the present invention.

[0019] It should be understood in the description of the present invention that the directions or positional relationships represented by terms such as "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are the directions or positional relationships represented based on the drawings, and are only used for the convenience of the description of the present invention to simplify the description, but do not indicate or imply that the described device or component necessarily has a specific direction or is configured and operated in a specific direction, and should not be understood as a limitation of the present invention thereby.

[0020] Terms such as "first" and "second" are only used for the purpose of explanation, and should not be construed as indicating or suggesting relative importance or implying the quantity of the described technical features. Thus, the features limited by "first" or "second" may explicitly or implicitly include one or more of the said features. In the description of the present invention, unless otherwise specified, "plural" means two or more.

[0021] In the description of the present invention, it is necessary to interpret that the terms "attach", "connect", and "couple" should be understood in a broad sense unless there are specific regulations and limitations. For example, such terms may mean fixed connection, detachable connection, integral connection, mechanical connection, electrical connection, direct connection, indirect connection through a medium, or communication inside two components. Those skilled in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

[0022] As shown in FIG. 2, the low-pressure double-balloon anti-slip tracheal cannula of this embodiment has a main catheter 01. One end of the main catheter 01 is an insertion end 04, that is, the end close to the trachea of the patient, and the other end is an exposed end, that is, the end located outside the body of the patient. The main catheter 01 is made of medical PVC material, its inner diameter is 6 - 8 mm for adults, and its outer diameter is 8 - 10 mm.

[0023] On the outer peripheral wall of the main catheter 01, two independent balloons are provided at intervals along the axial direction, which are the first balloon 03 and the second balloon 02 respectively. The first balloon 03 is close to the insertion end 04 of the main catheter 01, and the second balloon 02 is located on one side of the first balloon 01 away from the insertion end 04. The axial interval between the first balloon 03 and the second balloon 02 is 1 to 3 cm, and they are arranged at intervals in the same axial direction along the outer peripheral wall of the main casing 01. Both the first balloon 03 and the second balloon 02 have independent cavities, and the interiors of the cavities do not communicate with each other. The outer diameter of the second balloon 02 after inflation is equal to the outer diameter of the first balloon 03 after inflation.

[0024] As shown in FIG. 1, the first balloon 03 is connected to the first inflation tube 08, and the second balloon 02 is connected to the second inflation tube 09. Both the first inflation tube 08 and the second inflation tube 09 extend along the tube wall of the main catheter 01, and their outer ends protrude from the side wall of the exposed end of the main catheter 01 respectively. Independent first control valves 05 and second control valves 10 are provided at the respective protruding ends. It is possible to control the inflation and deflation operations of the corresponding balloons using the first control valve 05.

[0025] The first inflation tube 08 is an independent gas supply path connecting the first balloon 03 to the first control valve 05, and the second inflation tube 09 is an independent gas supply path connecting the second balloon 02 to the second control valve 10. Both are used to supply an inflation medium to the corresponding balloon and, together with the corresponding control valve, can well understand to realize the on-off and flow rate adjustment of the inflation medium.

[0026] The first control valve 05 and the second control valve 10, as independent control components attached to the exposed ends of the corresponding inflation tubes, perform the main function of adjusting the inflation and deflation states of the corresponding balloons. By adopting the normal control valve structure for medical use and having a two-way adjustment ability, the injection speed of the medium can be controlled during inflation, the pressure gradient can be released during exhaust, and together with the pressure inspection assembly (for example, an airbag) at the exposed end of the filling tube, the pressure inside the balloon can be accurately controlled.

[0027] A drain port 11 and a lavage port 12 are provided on the side wall of the main catheter 01 in the area corresponding to the space between the first balloon 03 and the second balloon 02, and the drain port 11 and the lavage port 12 are spaced apart along the circumferential direction of the main catheter 01. Inside the main catheter 01, a drain pipe 06 and a lavage pipe 07 are provided along the longitudinal direction. One end of the drain pipe 06 communicates with the drain port 11, and the other end extends and protrudes from the exposed end of the main catheter 01, and is used to connect an external negative pressure suction device. One end of the lavage pipe 07 communicates with the lavage port 12, and the other end extends and protrudes from the exposed end of the main catheter 01, and is used to connect an external lavage fluid supply device.

[0028] It is well understood that during clinical use, after a healthcare professional accurately inserts the insertion end 04 of the main catheter 01 into the designated position along the patient's airway, low-pressure inflation is applied to the first balloon 03 via the first control valve 05, limiting the inflation pressure to 25-30 cmH2O, so that the outer wall of the first balloon 03 adheres tightly to the inner wall of the trachea, thereby achieving reliable sealing to the lower airway. Simultaneously, low-pressure inflation is applied to the second balloon 02 via the second control valve 10, so that after inflation, the outer wall of the second balloon 02 also adheres tightly to the inner wall of the trachea, thereby achieving effective isolation from upper secretions. Because there is an axial gap of 2 cm between the first balloon 03 and the second balloon 02, the outer wall of the main catheter 01 and the inner wall of the trachea do not directly contact each other in the area corresponding to this gap. Consequently, the inner walls of the first balloon 03 and the second balloon 02, the outer wall of the main catheter 01, and the inner wall of the trachea surround an annular sealed lavage and suction cavity. This cavity functions as a relatively independent working space, providing a structural basis for precise lavage and highly efficient suction.

[0029] During clinical procedures, when a healthcare worker activates the lavage fluid supply device, sterile lavage fluid is sent through the lavage tube 07 to the lavage port 12 and precisely injected into the sealed lavage suction cavity. This precisely cleanses the biofilm, viscous secretions, and residual contaminants attached to the tracheal wall in this area. Simultaneously, the negative pressure suction device activates, creating a stable negative pressure within the sealed lavage suction cavity via the drainage tube 06 and drainage port 11, simultaneously drawing out the wastewater, detached secretions, and residual lavage fluid from the body.

[0030] As shown in Figure 3-4, annular grooves are provided on the outer circumferential wall of the first balloon 03, and there are 2 to 3 of these annular grooves, which are continuously distributed along the circumferential direction of the first balloon 03. Point-like protrusions are provided on the outer circumferential wall of the second balloon 02, and these point-like protrusions have an evenly distributed hemispherical structure, with a height of 0.3 to 0.5 mm.

[0031] This embodiment is largely identical in structure to that of Embodiment 1, with the following differences.

[0032] The axial distance between the first balloon 03 and the second balloon 02 is 3 cm, which is suitable for the tracheal structure of patients with short necks and large bodies.

[0033] On the side wall of the main catheter 01, two drainage ports and two irrigation ports are provided in the area corresponding to the space between the first balloon 03 and the second balloon 02. The two drainage ports and the two irrigation ports are arranged symmetrically, and the drainage ports and irrigation ports are arranged alternately at intervals.

[0034] The first and second filling tubes 08 and 09 both extend axially along the outside of the main catheter 01's wall and are fixedly connected to the outer wall of the main catheter 01 using medical adhesive. Their respective protruding ends are coplanar with the end face of the exposed end of the main catheter 01, facilitating piping management during clinical procedures.

[0035] The specific instructions for using this device are as follows:

[0036] After inserting the insertion end 04 of the main catheter 01 into the patient's trachea, normal low-pressure inflation is applied to the lower first balloon 03, keeping the inflation pressure at 25-30 cmH2O, and only the sealing of the airway is performed.

[0037] The upper second balloon 02 can also be filled with a high-viscosity gel or saline solution, forming a soft fixing pad. This fixing pad does not pressurize the tracheal mucosa, but prevents the cannula from sliding up and down through frictional force from its large, soft contact surface with the tracheal wall.

[0038] In all embodiments of this invention, each component is made of a standard medical material produced using a proven manufacturing process, and can be manufactured using conventional medical device processing methods such as injection molding and vulcanization. During assembly, it is sufficient to ensure that there is no leakage of air or fluid at the connection points by simply fixing the balloon and inflation tube, the drain tube 06 and drain port 11, and the cleaning tube 7 and cleaning port 12, respectively, by heat fusion or sealing adhesive.

[0039] In actual application, it is possible to select different main cannula diameters, balloon distances, and connection port numbers according to the patient's age, tracheal structure, and medical condition. An independent first control valve is used to adjust the inflation state of the two balloons, and combined with negative pressure drainage and irrigation functions, it achieves clinical effects such as low pressure, leak prevention, and easy care.

[0040] It is a reasonable understanding for those skilled in the art that the above is merely a preferred embodiment of the present invention, and that even if the present invention were described in detail with reference to the above embodiments without limiting it, it would still be possible for those skilled in the art to modify the technical means described in each of the above embodiments or to replace some of their technical features with equivalent ones. Any modifications, equivalent substitutions, or improvements made within the scope of the spirit and principles of the present invention should be included within the scope of protection of the present invention. [Explanation of Symbols]

[0041] 01-Main catheter; 02-Second balloon; 03-First balloon; 04-Insertion end; 05-First control valve; 06-Drainage tube; 07-Irrigation tube; 08-First inflation tube; 09-Second inflation tube; 10-Second control valve; 11-Drainage port; 12-Irrigation port

Claims

1. The device has a main catheter, one end of which is an insertion end and the other end is an exposed end, and two independent balloons are spaced apart along the axial direction on the outer circumferential wall of the main catheter, designated as a first balloon and a second balloon, the first balloon being located on one side of the first balloon, approaching the insertion end of the main catheter, and the second balloon being located on the other side of the first balloon, away from the insertion end, and the first balloon and the second balloon are connected to independent inflation tubes; A drain port and a irrigation port are provided in the side wall of the main catheter in a region corresponding to the area between the first balloon and the second balloon, and the drain port and the irrigation port are spaced apart along the circumferential direction of the main catheter; An annular groove is provided on the outer circumferential wall of the first balloon, and point-like protrusions are provided on the outer circumferential wall of the second balloon. A low-pressure double-balloon type non-slip tracheal cannula characterized by its features.

2. The low-pressure double-balloon type non-slip tracheal cannula according to claim 1, characterized in that the axial distance between the first balloon and the second balloon is 1 to 3 cm.

3. The low-pressure double-balloon anti-slip tracheal cannula according to claim 1, characterized in that both the first balloon and the second balloon have an annular structure, and the first balloon and the second balloon are independent cavities, with the interiors of the cavities not communicating with each other.

4. The inflation tubes of the first balloon and the second balloon both extend along the wall of the main catheter, and their outer ends each protrude from the side wall of the exposed end of the main catheter. The low-pressure double-balloon type non-slip tracheal cannula according to feature 1.

5. The low-pressure double-balloon type anti-slip tracheal cannula according to claim 4, characterized in that an independent control valve is provided at the protruding end of each of the aforementioned inflation tubes.

6. A drainage tube and a irrigation tube are provided within the main catheter along its longitudinal direction, with one end of the drainage tube communicating with the drainage port and the other end extending and protruding from the exposed end of the main catheter; and one end of the irrigation tube communicating with the irrigation port and the other end extending and protruding from the exposed end of the main catheter. The low-pressure double-balloon type non-slip tracheal cannula according to feature 1.

7. The low-pressure double-balloon type non-slip tracheal cannula according to claim 1, characterized in that the outer diameter of the second balloon after inflation is equal to the outer diameter of the first balloon after inflation.

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