Tympanic membrane ventilation pipe, conveyor and system thereof

Abstract

The invention relates to the technical field of medical equipment, in particular to a tympanic membrane ventilation pipe, a conveyor and a catheterization system of the tympanic membrane ventilation pipe. The device is suitable for tympanic membrane ventilation pipe indwelling. 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. And the inner claw and the outer claw are bent to realize multi-point and internal and external bidirectional fixation. The invention further provides a brand-new conveyor which is used in cooperation with the tympanic membrane ventilation pipe to form a tympanic membrane ventilation pipe indwelling system, tympanic membrane incision is not conducted any more through tympanic membrane ventilation pipe indwelling, the cutting process, the leading-in process and the indwelling process are integrated, the puncture hole diameter size and depth are effectively controlled, accidental injuries are reduced, the operation safety degree is improved, the operation operation is simplified, and the operation duration is shortened.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a tympanostomy tube, a delivery device and a catheterization system thereof. It is applicable to tympanostomy tube catheterization. Background Art

[0002] Secretory otitis media (OME) is a common ear disease. Generally, it is treated with drugs. After drug treatment is ineffective, tympanostomy is mostly used to solve the problem. At present, most tympanostomy operations are to manually incise the tympanic membrane, use other devices to aspirate and remove pus in the ear, etc., and then use various surgical tools to assist in placing the tympanostomy tube at the incision. Due to the small space in the ear canal, the size of the incision depends mostly on the doctor's hand feeling and experience, which requires a high level of skill from the doctor and is prone to being too large or too small. If the incision is too large, the tympanostomy tube is likely to prolapse or fall into the tympanic cavity; if the incision is too small, catheterization is difficult and the incision needs to be re-cut. Secondly, various nerves are distributed on the tympanic membrane, and repeated treatment is very painful for patients, especially young children, who require general anesthesia, which causes irreversible harm to children and is expensive for surgery.

[0003] Therefore, we aim to change the current situation of tympanostomy, develop new technologies for the treatment of secretory otitis media tympanostomy, including catheter insertion devices, selection of tympanostomy tube materials and structural design, etc. The new surgical method is simple to operate, has a short catheterization time, and can be performed under local anesthesia in the outpatient clinic. Summary of the Invention

[0004] The purpose of the present invention is to provide a tympanostomy tube, a delivery device and a catheterization system thereof that are safe to use, have less trauma during catheterization, and have good subsequent recovery effects in view of the problems existing in the prior art.

[0005] The tympanostomy tube includes inner claws, a tube body and outer claws. The tube body is a hollow tube, and the two ends of the tube body are respectively fixedly connected to one end of the inner claws and the outer claws. The other ends of the inner claws and the outer claws are free ends; the free ends are made of shape memory alloy, and the free ends are in a straight state at 0°C and in a bent state at 20 to 40°C.

[0006] The material of the tube body is stainless steel, and the inner claws and the outer claws are TiNi shape memory alloy; the inner claws, the tube body and the outer claws are wrapped with silica gel or tetrafluoroethylene to form a wrapping layer.

[0007] The number of 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.

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

[0009] The inner claws and the outer claws are arranged alternately; the length of the outer claws ≥ the length of the inner claws, and the number of inner claws and outer claws is different.

[0010] The free end is in a straight state at a temperature of 0 °C, and the straight free end and the tube body form a straight tube; the free end is in a bent state at a temperature of 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. 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 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 part bulges radially.

[0011] A tympanostomy tube placement system includes a tympanostomy tube and a delivery device; the delivery device includes a puncture needle, a release tube, an outer tube, a connecting wire, an outer tube fixing seat, a connecting wire fixing seat, a button, an insurance button spring, an insurance button, a release spring, a left housing, and a right housing; One end of the outer tube is provided with a release tube, the other end of the outer tube is fixedly connected to the outer tube fixing seat, a hollow cavity is provided in the outer tube fixing seat, and the hollow cavity of the outer tube fixing seat and the tube cavity of the outer tube form a sliding channel; a puncture needle and a connecting wire are placed in the sliding channel, the puncture needle is clamped in the release tube, the puncture needle is divided into a spike end and a connecting end, the spike end extends out of the release tube, the connecting end is fixedly connected to one end of the connecting wire to form a sliding assembly, and a tympanostomy tube is placed in the gap between the puncture needle and the release tube; the other end of the connecting wire passes through the sliding channel and is connected to the connecting wire fixing seat, the outer tube fixing seat and the connecting wire fixing seat are clamped and installed by buckling the left housing and the right housing, the outer tube fixing seat is fixedly installed at the head of the housing end, a sliding gap is reserved between the outer tube fixing seat and the connecting wire fixing seat, the connecting wire fixing seat travels along the sliding gap in the housing, a release spring is provided at the rear end of the connecting wire fixing seat, the connecting wire fixing seat is meshed and connected with the button through a rack and gear assembly, the pressing part of the button extends out of the housing, a clamping groove is provided on the button, the insurance button is divided into a pressing part and a clamping pin, the clamping pin of the insurance button is inserted into the clamping groove of the button, and the insurance button spring of the insurance button pushes the clamping pin to insert into the clamping groove to achieve locking, and pressing the insurance button makes the clamping pin withdraw from the clamping groove to achieve unlocking, the release spring ejects the connecting wire fixing seat and the connecting wire to move along the sliding gap, the connecting wire pushes the puncture needle and the tympanostomy tube to extend out of the release tube, completing the installation of the tympanostomy tube, and by pressing the button, the connecting wire fixing seat and the connecting wire are driven to move reversely along the sliding gap, and the connecting wire drives the puncture needle to retract into the release tube, so that the tympanostomy tube is separated from the release tube.

[0012] A tympanostomy tube placement system includes a tympanostomy tube and a delivery device; the delivery device includes a release tube, an outer tube, a connecting wire, an outer tube fixing seat, a connecting wire fixing seat, a button, an insurance button spring, an insurance button, a release spring, a left housing, and a right housing; One end of the outer tube is sleeved with a release tube. An inclined cut is provided on the release tube, and a sliding groove is provided on the outer tube. A welding end is provided on the connecting wire, and the welding end is fixedly connected to the release tube. The connecting wire drives the release tube to move along the sliding groove of the outer tube. A tympanic ventilation tube is placed inside the release tube, and the tympanic ventilation tube is in close contact with one end of the outer tube. The other end of the outer tube is fixedly connected to an outer tube fixing seat. A hollow cavity is provided inside the outer tube fixing seat, and the hollow cavity of the outer tube fixing seat and the lumen of the outer tube form a sliding channel. The tympanic ventilation tube and the connecting wire are placed inside the sliding channel. The connecting wire passes through the sliding channel and is connected to a connecting wire fixing seat. The outer tube fixing seat and the connecting wire fixing seat are clamped and installed by buckling a left shell and a right shell. The outer tube fixing seat is fixedly installed at the end of the shell. A sliding gap is reserved between the outer tube fixing seat and the connecting wire fixing seat. The connecting wire fixing seat travels along the sliding gap inside the shell. A release spring is provided at the rear end of the connecting wire fixing seat. The connecting wire fixing seat is meshed and connected to a button through a rack and gear assembly. The pressing part of the button extends out of the shell. A clamping groove is provided on the button. The safety button is divided into a pressing part and a clamping pin. The clamping pin of the safety button is inserted into the clamping groove of the button. The safety button spring of the safety button pushes the clamping pin to insert into the clamping groove to achieve locking. The inclined cut of the release tube punctures the eardrum so that the tympanic ventilation tube reaches the eardrum. Pressing the safety button makes the clamping pin withdraw from the clamping groove to achieve unlocking. The release spring ejects the connecting wire fixing seat and the connecting wire to move in the reverse direction along the puncture direction. The connecting wire drives the release tube to move in the reverse direction to extend the tympanic ventilation tube, and the tympanic ventilation tube is separated from the release tube to complete the installation of the tympanic ventilation tube.

[0013] A tympanic ventilation tube catheterization system, wherein the puncture needle and the release tube are in clearance fit, and the mating connection end of the release tube and the puncture needle is claw-shaped, and the claw tips of the claw shape are along the release tube; marking points are provided on the outer wall of the release tube, and the marking points are engraved by laser or sprayed with fluorescence; the marking points are used for puncture positioning and subsequent reexamination to accurately identify the catheterization position; the tip of the puncture needle extends out of the release tube, and the extension dimension is 0.5-1.0 mm; the tip angle of the puncture needle 101 is 30-35°, 25-30°, 20-25°, and when the tip angle is less than 25°, a stepped needle can be used for gradual transition.

[0014] The left shell and the right shell are assembled to form a handle. The conveyor is a handheld conveyor. The outer tube of the conveyor is divided into a straight tube section and a bent tube section. The straight tube section and the bent tube section are connected and integrated. The bent tube section is used to change the bending angle of the outer tube 103.

[0015] The beneficial effects of the present invention are: The structure of this application is innovated entirely to change the existing traditional catheter placement structure. The free ends of the inner claw and the outer claw can be 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 firmness of the support, ensuring firm multi-point fixation on 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. This application provides a brand-new conveyor, which is used in conjunction with the tympanic ventilation tube to form a tympanic ventilation tube catheter placement system. The tympanic ventilation tube catheter placement no longer requires a tympanic incision. The processes of cutting, introducing, and catheter placement are integrated, effectively controlling the size and depth of the puncture aperture, reducing the occurrence of accidental injuries, improving the surgical safety, simplifying the surgical operation, and shortening the surgical duration. Description of the Drawings

[0016] Figure 1 It is a schematic structural diagram of the tympanic ventilation tube catheter placement system; Figure 2 It is a top view of the structure of the tympanic ventilation tube catheter placement system; Figure 3 It is a side view of the structure of the tympanic ventilation tube catheter placement system; Figure 4 It is a cross-sectional view of the structure of the central puncture type conveyor; Figure 5 It is a partially enlarged view of the tympanic ventilation tube installed by the central puncture type conveyor during catheter placement; Figure 6 It is a partially enlarged view of the release tube of the central puncture type conveyor ejecting and pushing out the tympanic ventilation tube; Figure 7 It is a partially enlarged view of the tympanic ventilation tube placed in the tympanic membrane; Figure 8 It is a cross-sectional view of the structure of the beveled puncture type conveyor; Figure 9 It is a schematic diagram of the puncture state of the beveled puncture type conveyor; Figure 10 It is a schematic diagram of the state of the tympanic ventilation tube placed by the beveled puncture type conveyor; Figure 11 It is a schematic diagram of the structure of the two-claw tympanic ventilation tube; Figure 12 It is a schematic diagram of the structure of the three-claw tympanic ventilation tube; Figure 13 It is a schematic diagram of the structure of the four-claw tympanic ventilation tube; Figure 14 It is a schematic diagram of the structure of the hollow channel tube cavity of the tube body; Figure 15 It is a schematic diagram of the structure of the hollow channel horn cavity of the tube body; Figure 16 It is a schematic diagram of the structure of the hollow channel arc cavity of the tube body; Figure 17 It is a schematic diagram of the structure of the four-claw claw type release tube; Figure 18 It is a side view of the claw type release tube; Figure 19 It is a schematic diagram of the structure of the puncture needle; Figure 20 It is a schematic diagram of the step needle transition and gradual change of the puncture needle; Figure 21 It is a side view of the button; Figure 22 It is a schematic diagram of the structure of the safety button; Figure 23 It is a schematic diagram of the structure of the outer tube fixing seat; Figure 24 It is a schematic diagram of the structure of the connecting wire fixing seat; In the figure: tympanic membrane catheter device 1, puncture needle 101, release tube 102, outer tube 103, connecting wire 104, outer tube fixing seat 105, connecting wire fixing seat 106, button 107, safety button spring 108, safety button 109, release spring 110, left shell 111, right shell 112, sliding groove 113, tympanic membrane ventilation tube 2, 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] Furthermore, the tube body 202 is made of stainless steel, and the inner claw 201 and the outer claw 203 are TiNi memory alloy; the inner claw 201, the tube body 202 and the outer claw 203 are wrapped with silicone or tetrafluoroethylene to form a wrapping layer. The tube body, the inner claw and the outer claw are processed with different materials to effectively control the cost of using the tympanic membrane ventilation tube. In addition, the stainless steel tube body ensures the stability of the dimensional performance of the core support, and the inner claw and the outer claw of the TiNi memory alloy realize the bending of the free end to achieve deformation fixation through the change of material temperature. In particular, different pipes and components use different materials to meet the needs of various uses. Among them, the silicone or tetrafluoroethylene wrapping layer wraps the metal material as a whole, and the metal foreign body sensation is reduced after the tympanic membrane ventilation tube is inserted, and the comfort during the insertion of the tympanic membrane ventilation tube is improved. The silicone or tetrafluoroethylene wrapping adopts a conventional spraying process to achieve rapid construction of the tympanic membrane ventilation tube wrapping layer.

[0019] Furthermore, 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. The number of inner claws 201 and outer claws 203 is different. If reinforced support is required inside the tympanic membrane, the number of inner claws 201 is greater than the number of outer claws 203. If reinforced support is required outside the tympanic membrane, the number of outer claws 203 is greater than the number of inner claws 201.

[0020] Furthermore, the free ends of the inner claw 201 and the outer claw 203 are in opposite directions; arc-shaped edges 204 are provided on the free ends of the inner claw 201 and the outer claw 203. The opposite directions of the free ends allow the inner claw and the outer claw to be fixed in both directions inside and outside, and the arc-shaped edges on the ends can effectively prevent the free ends from scratching the ear tissue during bending and deformation.

[0021] Furthermore, the inner claws 201 and the outer claws 203 are arranged in an interlaced manner; the length of the outer claws 203 is greater than the length of the inner claws 201. The inner claws and the outer claws are arranged in an interlaced manner and bent to unfold into a multi-layer petal shape after the tube is placed, so as to avoid the concentration of force in a certain place and reduce pain and foreign body sensation. The length of the outer claws 203 is greater than the length of the inner claws 201, and the supporting strength of the outer claws outside the tympanic membrane is strengthened.

[0022] Further, the free end is in a straight state at a temperature of 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 a temperature of 20 to 40°C, and the bent free end 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 claw end inner diameter dimension of the horn cavity is smaller than the outer claw end inner diameter dimension along the axial direction of the hollow channel; the inner claw end inner diameter dimension of the arc cavity is smaller than the outer claw end inner diameter dimension along the axial direction of the hollow channel and the middle part bulges radially. The dumbbell-shaped structure enables the hollow channel of the tube cavity to improve the drainage efficiency of accumulated fluid. The inner claw inner diameter of the horn cavity is 0.05 - 0.2 mm less than 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 increase in cross-sectional area leads to a decrease in flow velocity, 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, which is convenient for the effusion to be exported and improves the drainage efficiency. After the effusion in the arc cavity flows out along the radial bulge, the effusion flows rapidly downward along the radial bulge, effectively preventing backflow; at the same time, the radial bulge forms a barrier to effectively reduce the entry of dust and foreign objects into the eardrum through the arc cavity.

[0023] A tympanic ventilation tube placement system includes a tympanic ventilation tube 2 and a transporter 1; it includes a puncture needle 101, a release tube 102, an outer tube 103, a connecting wire 104, an outer tube fixing seat 105, a connecting wire fixing seat 106, a button 107, an insurance button spring 108, an insurance button 109, a release spring 110, a left housing 111, and a right housing 112; One end of the outer tube 103 is provided with a release tube 102, and the other end of the outer tube 103 is fixedly connected to the outer tube fixing seat 105. A hollow cavity is provided inside the outer tube fixing seat 105, and the hollow cavity of the outer tube fixing seat 105 and the lumen of the outer tube 103 form a sliding channel; a puncture needle 101 and a connecting wire 104 are placed in the sliding channel. The puncture needle 101 is clamped in the release tube 102. The puncture needle 101 is divided into a pointed end and a connecting end. The pointed end extends out of the release tube 102, and the connecting end is fixedly connected to one end of the connecting wire 104 to form a sliding assembly. A tympanic ventilation tube 2 is placed in the gap between the puncture needle 101 and the release tube 102; the other end of the connecting wire 104 passes through the sliding channel and is connected to the connecting wire fixing seat 106. The outer tube fixing seat 105 and the connecting wire fixing seat 106 are clamped and installed by a left housing 111 and a right housing 112. The outer tube fixing seat 105 is fixedly installed at the head of the housing end. A sliding gap is reserved between the outer tube fixing seat 105 and the connecting wire fixing seat 106. The connecting wire fixing seat 106 travels along the sliding gap inside the housing. A release spring 110 is provided at the rear end of the connecting wire fixing seat 106. The connecting wire fixing seat 106 is meshed and connected to a button 107 through a rack and gear assembly. The pressing part of the button 107 extends out of the housing. A clamping groove is provided on the button 107. The safety button 109 is divided into a pressing part and a clamping pin. The clamping pin of the safety button 109 is inserted into the clamping groove of the button 107. The safety button spring 108 of the safety button 109 pushes the clamping pin into the clamping groove to achieve locking. Pressing the safety button 109 makes the clamping pin withdraw from the clamping groove to achieve unlocking. The release spring 110 ejects the connecting wire fixing seat 106 and the connecting wire 104 to move along the sliding gap. The connecting wire 104 pushes the puncture needle 101 and the tympanic ventilation tube 2 out of the release tube 102 to complete the installation of the tympanic ventilation tube. By pressing the button 107, the connecting wire fixing seat 106 and the connecting wire 104 are driven to move in the reverse direction along the sliding gap. The connecting wire 104 drives the puncture needle 101 to retract into the release tube 102, so that the tympanic ventilation tube 2 is separated from the release tube 102.

[0024] The present application provides a brand-new central puncture transporter, which is used in cooperation with a tympanic ventilation tube to form a tympanic ventilation tube catheterization system. For tympanic ventilation tube catheterization, no tympanic incision is required. The processes of cutting, introducing, and catheterizing are integrated. By moving the button, the puncture moving dimension is set and locked by the safety button. The release tube of the transporter is sent into the ear canal close to the tympanic membrane through the outer tube. Unlocking the safety button is fired by the ejection of the release spring. The puncture needle penetrates the tympanic membrane and simultaneously pushes the tympanic ventilation tube into place. Moving the button again withdraws the puncture needle from the tympanic ventilation tube. The transporter is taken out of the ear canal to complete the cutting, introducing, and catheterizing in one step. At the same time, the tympanic incision and the outer diameter dimension of the tympanic ventilation tube are unified, and there will be no situation of too large or too small incisions. The above-mentioned equipment can be repeatedly used after cleaning and disinfection. The tympanic ventilation tubes can be prefabricated in different sizes and different diameters of the hollow channels. By adjusting the sizes of the release tube and the outer tube, the matching installation can be controlled. Among them, by prefabricating different sizes and specifications, it can be adjusted for different patients.

[0025] A tympanostomy tube placement system includes a tympanostomy tube 2 and a delivery device 1; it includes a release tube 102, an outer tube 103, a connecting wire 104, an outer tube fixing seat 105, a connecting wire fixing seat 106, a button 107, a safety button spring 108, a safety button 109, a release spring 110, a left housing 111 and a right housing 112; One end of the outer tube 103 is sleeved with the release tube 102. An inclined cut is provided on the release tube 102, and a sliding groove 113 is provided on the outer tube 103. A welded end is provided on the connecting wire 104, and the welded end is fixedly connected to the release tube 102. The connecting wire 104 drives the release tube 102 to move along the sliding groove 113 of the outer tube 103. The tympanostomy tube 2 is placed in the release tube 102, and the tympanostomy tube 2 is in close contact with one end of the outer tube 103. The other end of the outer tube 103 is fixedly connected to the outer tube fixing seat 105. A hollow cavity is provided in the outer tube fixing seat 105, and the hollow cavity of the outer tube fixing seat 105 and the lumen of the outer tube 103 form a sliding channel. The tympanostomy tube 2 and the connecting wire 104 are placed in the sliding channel. The connecting wire 104 passes through the sliding channel and is connected to the connecting wire fixing seat 106. The outer tube fixing seat 105 and the connecting wire fixing seat 106 are snap-fitted and installed through the left housing 111 and the right housing 112. The outer tube fixing seat 105 is fixedly installed at the end of the housing. A sliding gap is reserved between the outer tube fixing seat 105 and the connecting wire fixing seat 106. The connecting wire fixing seat 106 travels along the sliding gap inside the housing. A release spring 110 is provided at the rear end of the connecting wire fixing seat 106. The connecting wire fixing seat 106 is meshed and connected to the button 107 through a rack and pinion assembly. The pressing part of the button 107 extends out of the housing. A clamping groove is provided on the button 107. The safety button 109 is divided into a pressing part and a clamping pin. The clamping pin of the safety button 109 is inserted into the clamping groove of the button 107. The safety button spring 108 of the safety button 109 pushes the clamping pin into the clamping groove to achieve locking. The inclined cut of the release tube 102 punctures the eardrum so that the tympanostomy tube reaches the eardrum. Pressing the safety button 109 causes the clamping pin to withdraw from the clamping groove to achieve unlocking. The release spring 110 ejects the connecting wire fixing seat 106 and the connecting wire 104 to move in the reverse direction along the puncture direction. The connecting wire 104 drives the release tube 102 to move in the reverse direction to extend the tympanostomy tube 2, and the tympanostomy tube 2 is separated from the release tube 102 to complete the installation of the tympanostomy tube.

[0026] The present application provides a brand-new bevel-cut puncture delivery device, which is used in cooperation with a tympanostomy tube to form a tympanostomy tube placement system, and tympanostomy tube placement no longer requires a tympanic membrane incision. The processes of cutting, introducing, and placing the tube are integrated. The inclined incision of the release tube punctures the tympanic membrane so that the tympanostomy tube reaches the tympanic membrane. Press the safety button to make the clamping pin withdraw from the clamping groove to achieve unlocking. The release spring ejects the connecting wire fixing seat and the connecting wire to move in the reverse direction along the puncture direction. The connecting wire drives the release tube to move in the reverse direction to extend the tympanostomy tube, and the tympanostomy tube detaches from the release tube to complete the installation of the tympanostomy tube. The cutting, introducing, and placing are completed in one step. Among them, the outer tube fixing seat 105, the connecting wire fixing seat 106, the left housing 111, and the right housing 112 are processed by traditional injection molding processes. The outer tube fixing seat 105 and the connecting wire fixing seat 106 are clamped in the left housing 111 and the right housing 112. The left housing 111 and the right housing 112 are buckled and clamped into an integral structure. The clamping and splicing adjustment of the outer tube fixing seat 105, the connecting wire fixing seat 106 with the left housing 111 and the right housing 112 are conventional techniques in the art and will not be elaborated here.

[0027] Further, the puncture needle 101 and the release tube 102 are in clearance fit. The mating connection end of the release tube 102 and the puncture needle 101 is claw-shaped, and the claw tips of the claw shape are along the release tube 102. The outer wall of the release tube 102 is provided with marking points, which are engraved by laser or sprayed with fluorescence. The marking points are used for puncture positioning and subsequent reexamination to accurately identify the tube placement position. The tip of the puncture needle 101 extends out of the release tube 102, and the extension dimension is 0.5-1.0 mm. The tip angle of the puncture needle 101 is 30-35°, 25-30°, 20-25°. When the tip angle is less than 25°, a stepped needle can be used for transitional gradient. The puncture effect at 30-35° is weak and is suitable for use when the tympanic membrane is thin or damaged. The puncture effect at 20-25° has a sharp tip and is suitable for puncturing the tympanic membrane when it is thick or there is stubborn cerumen in the external ear. The puncture effect at 25-30° is moderate and is suitable for most ordinary patients. The marking points are engraved by laser and observed with an ear canal endoscope for puncture positioning and tube placement position. Fluorescently sprayed marking points can also be added for subsequent inspection of whether the tympanostomy tube has fallen off and whether the tube placement position is accurate.

[0028] The left housing 111 and the right housing 112 are assembled to form a handle. The delivery device 1 is a handheld delivery device. The outer tube 103 of the delivery device 1 is divided into a straight tube section and a bent tube section. The straight tube section and the bent tube section are connected and integrated. The bent tube section is used to change the bending angle of the outer tube 103. Through the transition of the bent tube section, the observation and operation space of the handheld delivery device can be improved.

[0029] A sliding clearance is reserved between the outer tube fixing seat and the connecting wire fixing seat, and the puncture depth is accurately controlled through the sliding clearance. Another function of the outer tube fixing seat is to limit and stop to prevent accidental excessive insertion and assist in positioning the puncture tip of the puncture needle. The handheld end is provided with a button and a safety button to prevent accidental touch of the release device; the handle structure conforms to ergonomics and can be used by left-handed or right-handed users.

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 respectively fixedly connected to one end of the inner claw (201) and the outer claw (203). 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 a temperature of 0 °C and in a bent state at a temperature of 20 to 40 °C.

2. The tympanostomy tube according to claim 1, wherein The material of the tube body (202) is stainless steel, and 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 wrapped with silica gel or polytetrafluoroethylene to form a wrapping layer.

3. The tympanostomy tube according to claim 1, characterized in that The number of the inner claws (201) or the outer claws (203) of the tube body (202) is 2 - 4. 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).

4. The tympanostomy tube according to claim 1, characterized in that The end directions of the free ends of the inner claw (201) and the outer claw (203) are opposite. An arc edge (204) is provided at the free ends of the inner claw (201) and the outer claw (203).

5. The tympanic ventilation tube according to claim 3, characterized in that The inner claw (201) and the outer claw (203) are arranged alternately. The length of the outer claw (203) ≥ the length of the inner claw (201). The numbers of the inner claw (201) and the outer claw (203) are different.

6. The tympanic ventilation tube according to claim 1, characterized in that The free ends are in a straight state at a temperature of 0 °C. The free ends in the straight state and the tube body (202) form a straight tube. The free ends are in a bent state at a temperature of 20 to 40 °C. The free ends in the bent state and the tube body (202) form a dumbbell shape. A hollow channel is provided in the tube body (202). The hollow channel is a tube cavity, a horn cavity, and an arc cavity. The inner diameter of the tube cavity remains unchanged along the axial direction of the hollow channel. The inner diameter of the horn cavity at the inner claw end is smaller than that at the outer claw end along the axial direction of the hollow channel. The inner diameter of the arc cavity at the inner claw end is smaller than that at the outer claw end along the axial direction of the hollow channel and bulges radially in the middle.

7. A tympanostomy tube placement system, characterized in that It includes the tympanic membrane ventilation tube (2) and the transporter (1) according to any one of claims 1 to 6. The transporter (1) includes a puncture needle (101), a release tube (102), an outer tube (103), a connecting wire (104), an outer tube fixing seat (105), a connecting wire fixing seat (106), a button (107), an insurance button spring (108), an insurance button (109), a release spring (110), a left housing (111) and a right housing (112). A release tube (102) is provided at one end of the outer tube (103), and the other end of the outer tube (103) is fixedly connected to an outer tube fixing seat (105). A hollow cavity is provided in the outer tube fixing seat (105), and the hollow cavity of the outer tube fixing seat (105) and the tube cavity of the outer tube (103) form a sliding channel; a puncture needle (101) and a connecting wire (104) are placed in the sliding channel, and the puncture needle (101) is clamped in the release tube (102). The puncture needle (101) is divided into a spike end and a connecting end, and the spike end extends out of the release tube (102), and the connecting end is connected to the connecting wire (104). The ends are fixedly connected to form a sliding assembly, and the tympanic membrane ventilation tube (2) is placed in the gap between the puncture needle (101) and the release tube (102); the other end of the connecting wire (104) passes through the sliding channel and is connected to the connecting wire fixing seat (106); the outer tube fixing seat (105) and the connecting wire fixing seat (106) are snap-fitted and clamped together through the left shell body (111) and the right shell body (112); the outer tube fixing seat (105) is fixedly installed on the end head of the shell body, and a sliding gap is reserved between the outer tube fixing seat (105) and the connecting wire fixing seat (106), and the connecting wire fixing seat (106) slides along the inner side of the shell body. The connecting wire fixing seat (106) is provided with a release spring (110) at the rear end, the connecting wire fixing seat (106) is meshed with the button (107) through a rack and pinion assembly, a pressing portion of the button (107) extends out of the housing, a snap-in groove is provided on the button (107), the safety button (109) is divided into a pressing portion and a snap-in pin, the snap-in pin of the safety button (109) is inserted into the snap-in groove of the button (107), a safety button spring (108) of the safety button (109) pushes the snap-in pin into the snap-in groove to achieve locking, and the snap-in pin is withdrawn when the safety button (109) is pressed. The unlocking is achieved by exiting the card slot, and the release spring (110) ejects the connecting wire fixing seat (106) and the connecting wire (104) to move along the sliding gap, and the connecting wire (104) pushes the puncture needle (101) and the tympanic membrane ventilation tube (2) to extend out of the release tube (102), thereby completing the installation of the tympanic membrane ventilation tube. By pressing the button (107), the connecting wire fixing seat (106) and the connecting wire (104) are driven to move in the opposite direction along the sliding gap, and the connecting wire (104) drives the puncture needle (101) to be recovered to the release tube (102), so that the tympanic membrane ventilation tube (2) is separated from the release tube (102).

8. A tympanostomy tube placement system, characterized in that The invention comprises the tympanic membrane ventilation tube (2) and the conveyor (1) as claimed in any one of claims 1 to 6; the conveyor (1) comprises a release tube (102), an outer tube (103), a connecting wire (104), an outer tube fixing seat (105), a connecting wire fixing seat (106), a button (107), a safety button spring (108), a safety button (109), a release spring (110), a left shell (111) and a right shell (112); One end of the outer tube (103) is sleeved with a release tube (102). An inclined cut is provided on the release tube (102), and a sliding groove (113) is provided on the outer tube (103). The connecting wire (104) is provided with a welding end head, and the welding end head is fixedly connected to the release tube (102). The connecting wire (104) drives the release tube (102) to move along the sliding groove (113) of the outer tube (103). The tympanic membrane ventilation tube (2) is placed in the release tube (102), and the tympanic membrane ventilation tube (2) is in close contact with one end of the outer tube (103); the other end of the outer tube (103) is fixedly connected to the outer tube fixed seat (105). The outer tube fixed seat (105) is provided with a hollow cavity, and the hollow cavity of the outer tube fixed seat (105) and the lumen of the outer tube (103) form a sliding channel; the tympanic membrane ventilation tube (2) and the connecting wire (104) are placed in the sliding channel. The connecting wire (104) passes through the sliding channel and is connected to the connecting wire fixed seat (106). The outer tube fixed seat (105) and the connecting wire fixed seat (106) are snap-fitted by the left housing (111) and the right housing (112). The outer tube fixed seat (105) is fixedly installed at the end head of the housing. A sliding gap is reserved between the outer tube fixed seat (105) and the connecting wire fixed seat (106). The connecting wire fixed seat (106) travels along the sliding gap inside the housing. A release spring (110) is provided at the rear end of the connecting wire fixed seat (106). The connecting wire fixed seat (106) is meshed and connected to the button (107) through a rack and gear assembly. The pressing part of the button (107) extends out of the housing. A clamping groove is provided on the button (107). The safety button (106) is divided into a pressing part and a clamping pin. The clamping pin of the safety button (109) is inserted into the clamping groove of the button (107). The safety button spring (108) of the safety button (109) pushes the clamping pin to insert into the clamping groove to achieve locking. The inclined cut of the release tube (102) punctures the tympanic membrane so that the tympanic membrane ventilation tube reaches the tympanic membrane. Pressing the safety button (109) causes the clamping pin to withdraw from the clamping groove to achieve unlocking. The release spring (110) ejects the connecting wire fixed seat (106) and the connecting wire (104) to move in the reverse direction along the puncture direction. The connecting wire (104) drives the release tube (102) to move in the reverse direction to extend the tympanic membrane ventilation tube (2), and the tympanic membrane ventilation tube (2) disengages from the release tube (102) to complete the installation of the tympanic membrane ventilation tube.

9. The tympanic ventilation tube placement system according to claim 7, characterized in that The puncture needle (101) is in clearance fit with the release tube (102). The mating connection end of the release tube (102) and the puncture needle (101) is claw-shaped, and the claw tips of the claw shape are along the release tube (102); marking points are provided on the outer wall of the release tube (102), and the marking points are etched by laser or sprayed with fluorescence; the tip of the puncture needle (101) extends out of the release tube (102), and the extension dimension is 0.5 - 1.0 mm; the tip angle of the puncture needle (101) is 30 - 35°, 25 - 30°, 20 - 25°. When the tip angle is less than 25°, a stepped needle can be used for gradual transition.

10. The tympanic ventilation tube placement system according to claim 7, characterized in that The left housing (111) and the right housing (112) are assembled to form a handle. The outer tube (103) of the conveyor (1) is divided into a straight pipe section and a bent pipe section, and the straight pipe section and the bent pipe section are communicated and integrated.

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