Tympanic membrane ventilation pipe system

Abstract

The invention relates to the technical field of medical equipment, in particular to a tympanic membrane ventilation pipe system composed of a tympanic membrane ventilation pipe and a tympanic membrane ventilation pipe wrapping layer. 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] The present invention relates to the technical field of medical devices, in particular to a tympanostomy tube system composed of a tympanostomy tube and a wrapping layer of the tympanostomy tube, which is applicable to tympanostomy tube insertion. Background Art

[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 one of the common diseases in otolaryngology, and is more common in children. According to statistics, about 90% of preschool children have suffered from OME at least once, of which 50% occur before the age of 1, and this proportion rises to more than 60% by the age of 2. The incidence of OME in children under 3 years old is 11.7% - 20.8%, and the incidence drops to 2.68% - 8.13% at the age of 7. The incidence of high-risk children with OME (such as Down syndrome) is significantly increased, and the incidence rates in the two age groups of 1 year old and 6 - 7 years old are both higher than 60%.

[0003] Currently, medical treatment is mostly used. After medical treatment is ineffective, surgical treatment is adopted, and tympanostomy tube insertion is mostly used, that is, an opening is made in the tympanic membrane, and a tympanostomy tube is inserted to drain the liquid from the middle ear, reduce the accumulation or pressure reduction in the middle ear cavity. The function of the tympanostomy tube is to keep the tympanic membrane open for a sufficient long time after the operation, so that the pressure between the middle ear and the outer ear reaches balance, provide appropriate drainage for the effusion in the middle ear, and reduce infection. Usually, the ventilation tube needs to stay in the tympanic membrane for 6 to 24 months. However, the commonly used ventilation tubes in the prior art have many problems, such as difficult fixation, many complications, difficult operation, etc. The present invention aims to achieve a tympanostomy tube to improve the problems of tube blockage and poor drainage of middle ear effusion in the existing technology, conveniently insert the ventilation tube into the anatomical structure, and at the same time prevent accidental extrusion and facilitate removal. Summary of the Invention

[0004] The purpose of the present invention is to provide a tympanostomy tube with simple process, low cost, easy fixation, and can reduce problems such as tube blockage, extrusion, and shedding of tympanostomy tube insertion in view of the problems existing in the prior art. With the cooperation of tools, the operation can be changed to an outpatient operation and the product can be quickly inserted simply.

[0005] The tympanostomy tube includes an inner claw, a tube body, and an outer claw. The tube body is a hollow tube, and both ends of the tube body are fixedly connected to one end of the inner claw and 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 free ends are in a straight state at 0 °C, and the free ends are in a bent state at 20 to 40 °C.

[0006] Furthermore, the number of the inner claws or outer claws of the tube body is 2 - 4, there are gaps between adjacent inner claws or outer claws, and the inner claws or outer claws are evenly distributed along the circumference of the outer wall of the tube body.

[0007] Further, the free ends of the inner claw and the outer claw in the bent state are folded radially outward along the tube body, and the fold is arc-shaped.

[0008] Further, the folding angle between the inner claw and the outer claw and the tube body is 45°-75°.

[0009] Further, the end directions of the free ends of the inner claw and the outer claw are opposite; arc-shaped edges are provided at the free ends of the inner claw and the outer claw.

[0010] Further, the length of the outer claw ≥ the length of the inner claw, and the numbers of the inner claw and the outer claw are different.

[0011] Further, the free end is in a straight state at 0°C, and the straight free end and the tube body 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 form a dumbbell shape; a hollow channel is provided in the tube body, and the hollow channel is a tube cavity, a horn cavity, and an arc cavity; Further, the inner diameter dimension of the tube cavity along the axial direction of the hollow channel remains unchanged; the inner diameter dimension of the inner claw end of the horn cavity along the axial direction of the hollow channel is smaller than that of the outer claw end; the inner diameter dimension of the inner claw end of the arc cavity along the axial direction of the hollow channel is smaller than that of the outer claw end and the middle bulges radially.

[0012] The tympanic ventilation tube system includes a tympanic ventilation tube and a wrapping layer. The inner claw and the outer claw are made of TiNi shape memory alloy; the inner claw, the tube body, and the outer claw are sprayed with a wrapping material to form a silicone wrapping layer; the wrapping material is silicone or tetrafluoroethylene.

[0013] Further, the tube body material is stainless steel.

[0014] The advantages of the present invention compared with the traditional tympanic ventilation tube are: The structure of this application is innovated entirely new to change the existing traditional catheter structure. The free ends of the inner claw and the outer claw are bent at normal temperature through shape memory alloy. The bent states of the inner claw and the outer claw achieve multi-point and internal and external two-way fixation. Not only does the bent state of the inner claw and the outer claw increase the support area and support firmness, ensuring multi-point firm fixation of the eardrum in the ear, but also the two-way fixation of the inner claw and the outer claw solves the internal and external two-way fixation, completely eliminating the risks of slipping out of the ear canal outward and falling into the tympanic cavity inward.

[0015] The present invention is provided with an inner claw and an outer claw to improve internal and external fixation, and the outer ear and the inner ear are connected through a hollow channel, facilitating subsequent drainage, disinfection, cleaning, and interventional treatment. At the same time, temperature-controlled memory materials are used to expand or retract the inner claw and the outer claw, making it easy to insert and remove the tympanic ventilation tube; the tympanic ventilation tube is wrapped with a metal material or a composite material to ensure the support performance of the tube body, increase the drainage of middle ear effusion and have good biocompatibility, ensure the fluidity of effusion drainage, improve the drainage efficiency, and avoid unsmooth drainage. Description of the Drawings

[0016] Figure 1 It is a schematic diagram of the structure of the two-claw tympanic membrane ventilation tube; Figure 2 It is a schematic diagram of the structure of a three-claw tympanic membrane ventilation tube; Figure 3 It is a schematic diagram of the structure of the four-claw tympanic membrane ventilation tube; Figure 4 It is a schematic diagram of the structure of the hollow channel tube cavity of the tube body; Figure 5 It is a schematic diagram of the structure of the horn cavity of the hollow channel of the tube body; Figure 6 It is a schematic diagram of the arc cavity structure of the hollow channel of the tube body; In the figure: inner claw 201, tube body 202, outer claw 203, arc-shaped edge 204. DETAILED DESCRIPTION

[0017] The tympanic membrane ventilation tube comprises 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 ends of the inner claw 201 and the outer claw 203 are free ends. The free ends are memory alloys. The free ends are in a straight state at a temperature of 0°C and in a bent state at a temperature of 20 to 40°C. The existing tympanic membrane ventilation tube adopts an incision on the tympanic membrane and is inserted. In the prior art, the insertion and fixation of the tube body is a technical difficulty. If the incision is too large, the tympanic membrane ventilation tube is easy to fall out or fall into the tympanic cavity; if the incision is too small, the tube placement is difficult and needs to be re-incised, which increases the difficulty and risk of the procedure. After the tube placement procedure is completed, there is still a risk of falling out or falling into the tympanic cavity due to the movement of the patient's body, which brings great troubles to the doctor and the patient during surgery and subsequent life. The structure of the present application is a new innovation to change the existing traditional tube placement structure. The free ends of the inner claw and the outer claw are bent at room temperature by memory alloy. The bent state of the inner and outer claws achieves multi-point and inside-outside bidirectional fixation, which not only increases the supporting area and support firmness, ensuring that the eardrum in the ear is firmly fixed at multiple points, but also the bidirectional fixation of the inner and outer claws solves the inside-outside bidirectional fixation, completely eliminating the risk of falling out of the ear canal and falling into the tympanic cavity.

[0018] The number of inner claws 201 or outer claws 203 of the tube body 202 is 2-4, and gaps are provided between adjacent inner claws 201 or outer claws 203, and 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 patients with different eardrums. When the eardrum is thin and damaged, more groups can be selected to improve the local fixation performance, prevent it from slipping out of the ear canal and falling into the tympanic cavity, and avoid secondary fixation due to loose fixation. When the eardrum structure is complete, fewer groups can be selected to reduce the foreign body sensation and improve comfort. Different groups can also be flexibly selected according to age and eardrum thickness. Gaps are provided between adjacent inner claws 201 or outer claws 203, and the inner claws and outer claws have better bending and activity space, which effectively ensures that the inner claws and outer claws of the memory alloy are bent and deformed in place.

[0019] The free ends of the inner claw 201 and the outer claw 203 in the bent state are folded outward along the radial direction of the tube body 202, and the folding is in an arc shape. The folding angle between the inner claw 201 and the outer claw 203 and the tube body 202 is 45°-75°. The free ends of the inner claw 201 and the outer claw 203 are in opposite directions; the free ends of the inner claw 201 and the outer claw 203 are provided with an arc edge 204. The opposite directions of the free ends make the inner claw and the outer claw fixed in both directions inside and outside, and the arc edge is provided on the end to effectively prevent the free ends from scratching the ear tissue during bending and deformation.

[0020] The inner claws 201 and the outer claws 203 are arranged alternately; the length of the outer claws 203 ≥ the length of the inner claws 201. The free ends are in a straight state at a temperature of 0 °C, and the straight free ends and the tube body 202 form a straight tube shape; the free ends are in a bent state at a temperature of 20 to 40 °C, and the bent free ends and the tube body 202 form a dumbbell shape; a hollow channel is provided in the tube body 202, and the hollow channel is a tube cavity, a horn cavity, and an arc cavity; the inner diameter dimension of the tube cavity remains unchanged along the axial direction of the hollow channel; the inner diameter dimension of the inner claw end of the horn cavity is smaller than that of the outer claw end along the axial direction of the hollow channel; the inner diameter dimension of the inner claw end of the arc cavity is smaller than that of the outer claw end along the axial direction of the hollow channel and the middle bulges radially. After the inner claws and the outer claws are arranged alternately and the tube is bent and unfolded, it forms a multi-layer petal shape, avoiding stress concentration at a certain place and reducing pain and foreign body sensation. The length of the outer claws 203 is greater than or equal to the length of the inner claws 201, strengthening the support strength of the outer claws outside the eardrum. The dumbbell-shaped structure enables the hollow channel of the tube cavity to improve the drainage efficiency of the effusion. The inner claw inner diameter of the horn cavity is reduced by 0.05 - 0.2 mm compared with the outer claw inner diameter. According to the fluid Bernoulli principle, when the ear effusion flows from the narrow cross-section of the horn cavity into the gradually expanding horn mouth, the cross-sectional area increases, resulting in a decrease in the flow rate, and the effusion is exported more smoothly. The outer claw connection end of the gradually expanding horn mouth is lower than the inner claw connection end of the horn mouth, facilitating the export of the effusion and improving the drainage efficiency. After the effusion in the arc cavity flows out along the radially bulging part, the effusion quickly flows down along the radially bulging part, effectively preventing backflow; at the same time, the radially bulging part forms a barrier, effectively reducing the entry of dust and foreign bodies into the eardrum through the arc cavity. The number of the inner claws 201 and the outer claws 203 is different. If strengthening support inside the eardrum is needed, the number of the inner claws 201 is greater than the number of the outer claws 203; if strengthening support outside the eardrum is needed, the number of the outer claws 203 is greater than the number of the inner claws 201.

[0021] The tympanic ventilation tube system includes a tympanic ventilation tube and a wrapping layer. The inner claws 201 and the outer claws 203 are made of TiNi shape memory alloy; the inner claws 201, the tube body 202, and the outer claws 203 are sprayed with a wrapping material to form a silica gel wrapping layer; the wrapping material is silica gel or tetrafluoroethylene. The material of the tube body 202 is stainless steel. The tube body, the inner claws, and the outer claws are processed with different materials, effectively controlling the use cost of the tympanic ventilation tube. In addition, the stainless steel tube body ensures the stable dimensional performance of the core support member, and the inner claws and the outer claws made of TiNi shape memory alloy realize the bending of the free ends and the deformation fixation through the change of the material temperature. In particular, different pipe fittings and components use different materials to meet diverse application requirements. Among them, the silica gel or tetrafluoroethylene wrapping layer wraps the metal material as a whole. After the tympanic ventilation tube is implanted, it reduces the metal foreign body sensation and improves the comfort during the implantation of the tympanic ventilation tube. The silica gel or tetrafluoroethylene wrapping adopts a conventional spraying process to realize the rapid construction of the wrapping layer of the tympanic ventilation tube.

[0022] To achieve the above object, the present invention is specifically described in combination with the embodiments as follows: The tympanic ventilation tube of the present invention includes inner claws, a tube body, and outer claws. The two ends of the tube body are outer claws extending outward. 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 diameter of the flange of the inner claw is 2.5 - 3.0 mm, the diameter of the flange of the outer claw is 3.2 - 4.0 mm, the radius of the outward bend of the inner claw and the outer claw is 0.2 - 0.3 mm, and the circumferential distribution of the inner claw and the outer claw is 60° - 180°, improving the stability of the internal and external fixation of the ventilation tube. The tube body of the tympanic ventilation tube is made of a rigid hard material. The tympanic ventilation tube is preformed by laser cutting and then thermoformed to produce a temperature control or superelastic memory function. This structure can improve the convenience of inserting and removing the ventilation tube, prevent extrusion, and maintain the structural stiffness of the ventilation tube. The wrapping material is silicone or tetrafluoroethylene, which has good biocompatibility and flexibility, improving the comfort of the patient. At the same time, it can reduce infection and facilitate removal, while the stiffness of the tube body ensures that the inner cavity is not easily extruded and deformed, reducing the blockage rate.

[0023] The technical solution provided by the present invention will be described in more detail with reference to the accompanying drawings: The usage method of the tympanic ventilation tube specifically includes the following steps: 1) Prepare a metal pipe with a wall thickness of 0.05 - 0.1 mm, clean the surface of the metal pipe to obtain the processed pipe raw material; 2) Laser cut and post-process the processed pipe raw material to machine inner claws, a tube body, and outer claws; 3) Heat-treat the processed parts to endow them with a temperature memory or superelastic function; 4) The free end is made of shape memory alloy. The free end is in a straight state at a temperature of 0 °C. Implant the tympanic ventilation tube into the incised tympanic membrane; 5) At a temperature of 20 to 40 °C in the ear, the free ends of the bent inner claw 201 and outer claw 203 are turned radially outward along the tube body 202 to be in a bent state, and the fold is in an arc shape. The folding angles of the inner claw 201 and the outer claw 203 with the tube body 202 are 45° - 75°. The inner claw and the outer claw are fixed bidirectionally to solve the internal and external bidirectional fixation.

Claims

1. A tympanostomy 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 ends of the inner claw (201) and the outer claw (203) are free ends. The free ends are made of shape memory alloy. The free ends are in a straight state at 0 °C, and the free ends are in a bent state at 20 to 40 °C.

2. The tympanostomy tube according to claim 1, wherein The number of the inner claws (201) or the outer claws (203) of the tube body (202) is 2 - 4 groups. There are gaps between adjacent inner claws (201) or outer claws (203). The inner claws (201) or the outer claws (203) are evenly distributed along the circumference of the outer wall of the tube body (202).

3. The tympanic ventilation tube according to claim 1, wherein The free ends of the bent inner claws (201) and outer claws (203) are folded outward along the radial direction of the tube body (202), and the fold is arc-shaped.

4. The tympanic ventilation tube according to claim 3, wherein The folding angle between the inner claws (201) and the outer claws (203) and the tube body (202) is 45° - 75°.

5. The tympanic ventilation tube according to claim 1, characterized in that The end directions of the free ends of the inner claws (201) and the outer claws (203) are opposite; arc-shaped edges (204) are provided at the free ends of the inner claws (201) and the outer claws (203).

6. The tympanostomy tube according to claim 3, wherein The inner claws (201) and the outer claws (203) are arranged alternately; the length of the outer claws (203) ≥ the length of the inner claws (201); the numbers of the inner claws (201) and the outer claws (203) are different.

7. The tympanic ventilation tube according to claim 1, wherein The free ends are in a straight state at 0 °C, and the straight free ends and the tube body (202) form a straight tube shape; the free ends are in a bent state at 20 to 40 °C, and the bent free ends and the tube body (202) form a dumbbell shape; a hollow channel is provided in the tube body (202), and the hollow channel is a tube cavity, a horn cavity, and an arc cavity.

8. The tympanostomy tube according to claim 6, wherein The inner diameter dimension of the tube cavity remains unchanged along the axial direction of the hollow channel; the inner diameter dimension of the inner claw end of the horn cavity is smaller than that of the outer claw end along the axial direction of the hollow channel; the inner diameter dimension of the inner claw end of the arc cavity is smaller than that of the outer claw end along the axial direction of the hollow channel and bulges radially in the middle.

9. A tympanostomy tube system, characterized in that It includes the tympanic ventilation tube and the wrapping layer according to any one of claims 1 to 8. 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 sprayed with a wrapping material to form a silicone wrapping layer; the wrapping material is silicone or tetrafluoroethylene.

10. The tympanostomy tube system according to claim 9, wherein The material of the tube body (202) is stainless steel.

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