Tympanic membrane ventilation pipe

Abstract

The utility model relates to the technical field of medical equipment, in particular to a tympanic membrane ventilation pipe. The device is suitable for tympanic membrane catheterization. The tympanic membrane ventilation pipe comprises an inner claw, a pipe body and an outer claw, the pipe body is a hollow pipe, the two ends of the pipe body are fixedly connected with one end of the inner claw and one end of the outer claw respectively, and the other ends of the inner claw and the outer claw are free ends; the free end is made of memory alloy, is in a straightened state at the temperature of 0 DEG C and is in a bent state at the temperature of 20-40 DEG C. The structure is newly innovated, and an existing traditional indwelling catheter structure is changed. And the free ends of the inner claw and the outer claw are bent in a normal-temperature state through the memory alloy. The bending state of the inner claw and the outer claw achieves multi-point and internal and external bidirectional fixation, the bending state of the inner claw and the outer claw increases the supporting area and the supporting firmness, multi-point firm fixation of the eardrum in the ear is ensured, internal and external bidirectional fixation is achieved through bidirectional fixation of the inner claw and the outer claw, and the risk that the eardrum falls out of the auditory meatus and falls into the tympanic chamber is thoroughly solved.

Description

Technical Field

[0001] This utility model relates to the field of medical equipment technology, and in particular to a tympanic membrane ventilation tube. It is suitable for tympanic membrane placement. Background Technology

[0002] Secretory otitis media (OME) is a non-suppurative inflammatory disease of the middle ear characterized by middle ear effusion and hearing loss. It is a common ear, nose, and throat disease, and is prevalent in children. Statistics show that approximately 90% of preschool children have had at least one episode of OME, with 50% occurring before the age of one, rising to over 60% by age two. The incidence of OME in children under three years old is 11.7%–20.8%, decreasing to 2.68%–8.13% by age seven. The incidence is significantly higher in children at high risk for OME (such as those with Down syndrome), exceeding 60% in both the one-year and six-to-seven-year age groups.

[0003] Currently, treatment primarily involves medication. When medication proves ineffective, surgical intervention is employed, often employing tympanic membrane intubation. This involves making an opening in the tympanic membrane and inserting a tympanic ventilation tube to drain fluid from the middle ear, reducing accumulation or pressure drop within the middle ear cavity. The function of the tympanic ventilation tube is to maintain the tympanic membrane open for a sufficient period post-surgery, allowing pressure balance between the middle and outer ear, providing adequate drainage for middle ear effusion, and reducing infection. The ventilation tube typically needs to remain in place for 6 to 24 months. However, existing ventilation tubes suffer from several problems, such as difficulty in fixation, numerous complications, and operational difficulties. This invention aims to provide a tympanic membrane ventilation tube that addresses the problems of tube blockage and poor drainage of tympanic cavity effusion in existing technologies. It allows for convenient insertion of the ventilation tube into the anatomical structure, preventing accidental expulsion and facilitating removal. Utility Model Content

[0004] The purpose of this invention is to address the problems existing in the prior art by providing a tympanic ventilation tube that is simple to manufacture, low in cost, easy to fix, and can reduce problems such as clogging, squeezing, and dislodgement of the tympanic duct.

[0005] The tympanic membrane ventilation tube includes an inner claw, a tube body, and an outer claw. The tube body is a hollow tube, with both ends fixedly connected to one end of the inner claw and one end of the outer claw, respectively. The other ends of the inner claw and the outer claw are free ends. The free ends are made of shape memory alloy. The tube body is made of stainless steel. The free ends are straight at 0°C and bent at 20 to 40°C. The inner claw (201) and the outer claw are made of TiNi shape memory alloy. The inner claw, tube body, and outer claw are coated with a silicone coating. The coating material is silicone or tetrafluoroethylene.

[0006] The tube body has 2-4 inner or outer claws, with gaps between adjacent inner or outer claws, and the inner or outer claws are evenly distributed along the circumference of the outer wall of the tube body.

[0007] The free ends of the inner and outer claws in the bent state are folded outward along the radial direction of the tube, forming an arc shape.

[0008] The free ends of the inner and outer claws are oriented in opposite directions; the free ends of the inner and outer claws are provided with arc-shaped edges.

[0009] The inner and outer claws are staggered; the length of the outer claw is greater than or equal to the length of the inner claw.

[0010] The free end is straight at 0°C, and the straight free end and the tube body form a straight tube; the free end is bent at 20 to 40°C, and the bent free end and the tube body form a dumbbell shape; the tube body is provided with a hollow channel, which is a tubular cavity, a trumpet cavity, or a circular arc cavity.

[0011] The advantages of this invention compared to traditional tympanic membrane ventilation tubes are:

[0012] This application presents a completely innovative structure that changes the existing traditional insertion tube structure. It utilizes a shape memory alloy to allow the free ends of the inner and outer claws to bend at room temperature. The bent state of the inner and outer claws achieves multi-point and bidirectional fixation, not only increasing the support area and stability to ensure secure fixation of the tympanic membrane at multiple points, but also completely eliminating the risk of the tube dislodging out of the ear canal or falling into the tympanic cavity.

[0013] This invention features inner and outer claws to improve internal and external fixation, and connects the outer and inner ear through a hollow channel, facilitating subsequent drainage, disinfection, cleaning, and interventional treatment. The inner and outer claws are expanded or retracted using temperature-controlled memory material, making it easy to insert and remove the tympanic membrane ventilation tube. The tympanic membrane ventilation tube is wrapped with metal or composite materials to ensure tube support performance, increase drainage of tympanic cavity effusion, and maintain good biocompatibility, ensuring fluid flow and improving drainage efficiency, thus preventing drainage obstruction. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of a two-claw tympanic membrane ventilation tube.

[0015] Figure 2 A schematic diagram of a three-pronged tympanic membrane ventilation tube;

[0016] Figure 3 A schematic diagram of a four-claw tympanic membrane ventilation tube;

[0017] Figure 4 This is a schematic diagram of the hollow channel tubular cavity structure within the tube body;

[0018] Figure 5 This is a schematic diagram of the hollow channel horn cavity structure in the tube;

[0019] Figure 6 This is a schematic diagram of the circular arc cavity structure of the hollow channel in the tube;

[0020] In the diagram: inner claw 201, tube body 202, outer claw 203, arc-shaped edge 204. Detailed Implementation

[0021] The tympanic membrane ventilation tube includes an inner claw 201, a tube body 202, and an outer claw 203. The tube body 202 is a hollow tube, with both ends fixedly connected to one end of the inner claw 201 and the outer claw 203, respectively. The other ends of the inner claw 201 and the outer claw 203 are free ends. The free ends are made of shape memory alloy, which is straight at 0°C and bent at 20-40°C. Existing tympanic membrane ventilation tubes are inserted through an incision in the tympanic membrane. The placement and fixation of the tube body in existing technologies is a technical challenge. If the incision is too large, the tympanic membrane ventilation tube is prone to dislodgement or falling into the tympanic cavity; if the incision is too small, placement becomes difficult and requires re-incision, increasing the complexity and risk of the procedure. Even after placement, the risk of dislodgement or falling into the tympanic cavity remains due to patient movement, causing significant inconvenience for both doctors and patients during surgery and in their subsequent lives. This application presents a completely innovative structure that changes the existing traditional placement structure. It utilizes a shape memory alloy to achieve bending of the free ends of the inner and outer claws at room temperature. The bending state of the inner and outer claws achieves multi-point and bidirectional fixation, which not only increases the support area and support firmness, ensuring that the tympanic membrane is firmly fixed at multiple points, but also solves the problem of bidirectional fixation, completely eliminating the risk of the eardrum dislodging out of the ear canal or falling into the tympanic cavity.

[0022] The tube body 202 has 2-4 inner claws 201 or outer claws 203, with gaps between adjacent inner claws 201 or outer claws 203. The inner claws 201 or outer claws 203 are evenly distributed along the circumference of the outer wall of the tube body 202. 2-4 inner claws 201 or outer claws 203 meet the needs of different tympanic membrane patients. When the tympanic membrane is thin or damaged, more groups can be selected to improve local fixation performance, preventing it from dislodging outwards from the ear canal or falling inwards into the tympanic cavity, avoiding the need for secondary fixation due to insecure fixation. When the tympanic membrane structure is intact, fewer groups can be selected to reduce foreign body sensation and improve comfort. Different numbers of groups can also be flexibly selected according to age and tympanic membrane thickness. The gaps between adjacent inner claws 201 or outer claws 203 provide better bending space for the inner and outer claws, effectively ensuring that the shape memory alloy inner and outer claws bend and deform appropriately.

[0023] The free ends of the bent inner claw 201 and outer claw 203 are folded outward radially along the tube body 202, forming an arc shape. The folding angle between the inner claw 201 and outer claw 203 and the tube body 202 is 45°-75°. The free ends of the inner claw 201 and outer claw 203 face opposite directions; each free end of the inner claw 201 and outer claw 203 has an arc-shaped edge 204. The opposite directions of the free ends ensure that the inner and outer claws are fixed in both directions, while the arc-shaped edge on the end effectively prevents scratching of the inner ear tissue during the bending and deformation process.

[0024] The inner claw 201 and outer claw 203 are staggered; the length of the outer claw 203 is greater than or equal to the length of the inner claw 201. The free end is straight at 0°C, forming a straight tube with the tube body 202; the free end is bent at 20-40°C, forming a dumbbell shape with the tube body 202. The tube body 202 contains a hollow channel, which can be a tubular cavity, a trumpet cavity, or an arc-shaped cavity. The inner diameter of the tubular cavity remains constant along the axial direction of the hollow channel; the inner diameter of the trumpet cavity at the inner claw end is smaller than that at the outer claw end; the inner diameter of the arc-shaped cavity at the inner claw end is smaller than that at the outer claw end and bulges radially in the middle. The staggered arrangement of the inner and outer claws, after insertion, causes the tube to bend and unfold into multiple petal-like shapes, avoiding concentrated stress in one area and reducing pain and foreign body sensation. The length of the outer claw 203 is greater than or equal to the length of the inner claw 201, strengthening the support strength of the outer claw outside the tympanic membrane. The dumbbell-shaped structure allows for improved drainage efficiency through the hollow channel within the tubular cavity. The inner diameter of the inner claw of the horn-shaped cavity is 0.05-0.2 mm smaller than that of the outer claw. According to Bernoulli's principle of fluid dynamics, when ear effusion flows from the narrow cross-section of the horn-shaped cavity into the gradually widening horn-shaped opening, the increased cross-sectional area leads to a decrease in flow velocity, resulting in smoother drainage. The connecting end of the outer claw at the gradually widening horn-shaped opening is lower than that of the inner claw, facilitating drainage and improving efficiency. After the ear effusion flows out along the radial bulge within the arc-shaped cavity, it flows rapidly downwards along the radial bulge, effectively preventing backflow. Simultaneously, the radial bulge forms a barrier, effectively reducing the entry of dust and foreign objects into the tympanic membrane through the arc-shaped cavity.

[0025] The inner claw 201 and outer claw 203 are made of TiNi shape memory alloy. The inner claw 201, tube body 202, and outer claw 203 are coated with a silicone coating material; the coating material is silicone or tetrafluoroethylene (PTFE). The tube body 202 is made of stainless steel. The tube body and the inner and outer claws are processed using different materials, effectively controlling the cost of the tympanic membrane ventilation tube. Furthermore, the stainless steel tube body ensures the dimensional stability of the core support component, while the TiNi shape memory alloy inner and outer claws achieve deformation fixation through material temperature changes during free-end bending. In particular, different materials are used for different tubes and components to meet diverse application requirements. The silicone or PTFE coating completely encapsulates the metal material, reducing the metallic foreign body sensation after the tympanic membrane ventilation tube is inserted, improving comfort during insertion. The silicone or PTFE coating uses a conventional spraying process, enabling rapid construction of the tympanic membrane ventilation tube coating.

[0026] To achieve the above objectives, the present invention will be described in detail below with reference to the embodiments:

[0027] The tympanic membrane ventilation tube of this utility model includes an inner claw, a tube body, and an outer claw. The two ends of the tube body are outwardly extending outer claws. The positions of the outer claws are staggered. The inner diameter of the tube body is 1.02-1.50 mm, the outer diameter is 1.2-1.7 mm, and the length is 3.0-6.0 mm. The inner claw flange diameter is 2.5-3.0 mm, the outer claw flange diameter is 3.2-4.0 mm, the outward bending radius of the inner and outer claws is 0.2-0.3 mm, and the circumferential distribution of the inner and outer claws is 60°-180°, which improves the stability of the ventilation tube's internal and external fixation.

[0028] The tympanic membrane ventilation tube is made of a rigid material. It is pre-formed by laser cutting and then thermoformed to give it temperature control or superelastic memory function. This structure can improve the ease of insertion and removal of the ventilation tube, prevent compression, and maintain the structural rigidity of the ventilation tube. The covering material is silicone or PTFE, which has good biocompatibility and flexibility to improve patient comfort, reduce infection, and facilitate removal. The rigidity of the tube body ensures that the inner cavity is not easily squeezed or deformed, reducing the blockage rate.

[0029] The technical solution provided by this utility model will be described in more detail below with reference to the accompanying drawings:

[0030] The instructions for using a tympanic membrane ventilation tube include the following steps:

[0031] 1) Prepare metal pipes with a wall thickness of 0.05~0.1mm, clean the surface of the metal pipes, and obtain the processed pipe raw materials;

[0032] 2) The processed pipe material is laser-cut into shape and post-processed to produce inner claws, pipe body, and outer claws;

[0033] 3) Perform heat treatment on the processed parts to give them temperature memory or super elasticity.

[0034] 4) The free end is made of shape memory alloy and is straight at 0°C. The tympanic ventilator is then inserted into the tympanic membrane through the incision.

[0035] 5) When the free ends are in the ear at a temperature of 20 to 40°C, the free ends of the bent inner claw 201 and outer claw 203 are folded outward along the radial direction of the tube body 202, forming an arc shape. The folding angle between the inner claw 201 and outer claw 203 and the tube body 202 is 45°-75°, and the bidirectional fixation of the inner and outer claws solves the problem of bidirectional fixation.

Claims

1. A tympanic membrane ventilation tube, characterized in that... It includes an inner claw (201), a tube body (202), and an outer claw (203). The tube body (202) is a hollow tube. The two ends of the tube body (202) are fixedly connected to one end of the inner claw (201) and the outer claw (203), respectively. The other end of the inner claw (201) and the outer claw (203) is a free end. The free end is made of shape memory alloy. The tube body (202) is made of stainless steel. The free end is straight at 0°C and bent at 20 to 40°C. The inner claw (201) and the outer claw (203) are made of TiNi shape memory alloy. The inner claw (201), the tube body (202), and the outer claw (203) are coated with a silicone coating material. The coating material is silicone or tetrafluoroethylene.

2. The tympanic membrane ventilation tube according to claim 1, characterized in that... The tube body (202) has 2-4 inner claws (201) or outer claws (203), and there are gaps between adjacent inner claws (201) or outer claws (203). The inner claws (201) or outer claws (203) are evenly distributed along the circumference of the outer wall of the tube body (202).

3. The tympanic membrane ventilation tube according to claim 1, characterized in that... The free ends of the bent inner claw (201) and outer claw (203) are folded outward along the radial direction of the tube body (202), forming an arc shape.

4. The tympanic membrane ventilation tube according to claim 1, characterized in that... The free ends of the inner claw (201) and the outer claw (203) are oriented in opposite directions; the free ends of the inner claw (201) and the outer claw (203) are provided with arc-shaped edges (204).

5. The tympanic membrane ventilation tube according to claim 3, characterized in that... The inner claw (201) and the outer claw (203) are staggered; the length of the outer claw (203) is greater than or equal to the length of the inner claw (201).

6. The tympanic membrane ventilation tube according to claim 1, characterized in that... The free end is in a straight state at 0°C, and the straight free end and the tube body (202) form a straight tube; the free end is in a bent state at 20 to 40°C, and the bent free end and the tube body (202) form a dumbbell shape; the tube body (202) is provided with a hollow channel, which is a tubular cavity, a trumpet cavity, or a circular arc cavity.

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