Eustachian tube support and releasing and feeding device thereof

Abstract

The Eustachian tube stent comprises a stent body and the stent body releasing device, the stent body is of a biconical hourglass structure, the two ends of the stent body are square belts (6-8), the middle of the stent body is provided with rhombic grids, the stent body is made of nickel-titanium alloy, the total length of the stent body is 25-35 mm, the outer diameter of the large end of the stent body is 6-9 mm, the outer diameter of the small end of the stent body is 3-4 mm, and the outer diameter of the thin waist of the stent body is 1-2 mm; the stent releasing and feeding device comprises a catheter (with scales), a push wire (an end ball head), a clamping stop head (thread adjustment) and a handle, and the placement depth of the stent is locked by rotating the stop head.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly to an eustachian tube stent and its delivery device. Background Art

[0002] The main clinical manifestations of eustachian tube dysfunction are a feeling of ear fullness, hearing loss, etc. Diseases such as secretory otitis media, chronic suppurative otitis media, cholesteatoma of the middle ear, and adhesive otitis media are common in clinical practice. Chronic delayed open eustachian tube dysfunction is one of the important pathogenesis mechanisms.

[0003] Conventional treatments include drug treatment, eustachian tube catheterization, myringotomy, tympanostomy tube insertion, etc., but all lack the efficacy of directly improving eustachian tube function. Most of the middle ear effusion and adhesions are related to the slit-like stenosis changes in the cartilaginous segment of the patient's eustachian tube, especially the pharyngeal orifice.

[0004] In view of the problems in the related art, no effective solution has been proposed yet. Summary of the Invention

[0005] In view of the problems in the related art, the present invention provides an eustachian tube stent and its delivery device to overcome the above technical problems existing in the existing related technologies.

[0006] Specifically, the technical solution adopted by the present invention is as follows:

[0007] An eustachian tube stent and its delivery device, comprising an eustachian tube stent and a delivery device. The delivery device includes a housing. A clamping head is screwed to the left end of the housing. A delivery catheter is installed inside the clamping head. An eustachian tube stent is installed inside the end of the delivery catheter. A wire pusher is provided on the right side of the eustachian tube stent.

[0008] As a further aspect of the present invention, the eustachian tube stent is made of a nitinol alloy tube and has an hourglass-shaped double-cone structure. The outer diameter of the eustachian tube stent is 1-2 mm, and the wall thickness is 0.15-0.35 mm; the outer diameter of the large head of the eustachian tube stent is 6-9 mm, and the length is 6-12 mm; the outer diameter of the small head of the eustachian tube stent is 3-4 mm, and the length is 5-8 mm; the outer diameter of the narrow waist of the eustachian tube stent is 1-2 mm, which matches the isthmus of the eustachian tube; both ends of the eustachian tube stent are 6-8 square bands with a width of 0.15-0.35 mm, and the middle part is a diamond grid; the total length of the eustachian tube stent is 25-35 mm, which is adapted to the adult eustachian tube with a length of about 31-38 mm.

[0009] As a further aspect of the present invention, a trigger is rotatably connected to the inside of the housing. The right end of the wire pusher is installed inside the trigger. The wire pusher is made of plastic or metal.

[0010] As a further solution of the present invention, ball heads are fixedly connected to both ends of the wire pusher, and the size of the ball head is between the inner diameter of the eustachian tube stent and the inner diameter of the delivery catheter.

[0011] As a further solution of the present invention, the delivery catheter is made of medical-grade plastic with a hardness of 80-110A. The inner wall of the delivery catheter is smooth and elastic, and a scale is provided at one end of the delivery catheter close to the housing.

[0012] As a further solution of the present invention, an external thread is provided on the outside of the clamping stop head to match the internal thread of the housing.

[0013] As a further solution of the present invention, a stop head sliding lock is slidably installed on the upper part of the housing, and the stop head sliding lock is engaged with the clamping stop head.

[0014] The beneficial effects of the present invention are as follows:

[0015] The present invention conforms to the eustachian tube anatomy through an hourglass shape design. The nitinol provides a lasting supporting force and reduces the recurrence rate; the clamping stop head and the scale cooperate to achieve millimeter-level positioning, and the sliding lock device prevents displacement during the operation; the elastic catheter adapts to the curved path of the eustachian tube, and the wire pusher ball head design avoids jamming when the stent is pushed out; the nitinol and the smooth catheter surface reduce tissue damage and are suitable for long-term implantation; the eustachian tube stent made of nitinol material can be placed in the eustachian tube for a long time to assist in improving the function of the eustachian tube and effectively reduce the recurrence probability of eustachian tube dysfunction. Description of the Drawings

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the embodiments. Obviously, the following described drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0017] Figure 1 It is a schematic diagram of the internal structure of the delivery device and the installation structure of the stent of the eustachian tube stent and its delivery device according to the embodiment of the present invention;

[0018] Figure 2 It is a schematic diagram of the overall structure of the eustachian tube stent of the eustachian tube stent and its delivery device according to the embodiment of the present invention;

[0019] Figure 3 It is a schematic diagram of the installation structure of the wire pusher in the delivery catheter of the eustachian tube stent and its delivery device according to the embodiment of the present invention;

[0020] Figure 4 It is a schematic diagram of the installation structure of the clamping stop head and the stop head sliding lock of the eustachian tube stent and its delivery device according to the embodiment of the present invention.

[0021] In the figure:

[0022] 1. Eustachian tube stent; 2. Delivery device; 21. Housing; 22. Handle; 23. Trigger; 24. Wire pusher; 241. Ball head; 25. Positioning stop; 26. Stop slide lock; 27. Delivery catheter. Detailed implementation manners

[0023] To further illustrate each embodiment, the present invention provides accompanying drawings, which are part of the disclosure of the present invention. They are mainly used to illustrate the embodiments and can be used in conjunction with the relevant descriptions in the specification to explain the operating principle of the embodiments. With reference to these contents, those of ordinary skill in the art should be able to understand other possible implementation manners and the advantages of the present invention. The components in the figures are not drawn to scale, and similar component symbols are usually used to represent similar components.

[0024] According to an embodiment of the present invention, there is provided an Eustachian tube stent and its delivery device.

[0025] Please refer to the accompanying specification Figures 1-4 , the Eustachian tube stent and its delivery device according to an embodiment of the present invention include an Eustachian tube stent 1 and a delivery device 2. The delivery device 2 includes a housing 21. A positioning stop 25 is screwed to the left end of the housing 2. A delivery catheter 27 is installed inside the positioning stop 25. An Eustachian tube stent 1 is installed inside the end of the delivery catheter 27. A wire pusher 24 is provided on the right side of the Eustachian tube stent 1.

[0026] In one embodiment, please refer to the accompanying specification Figures 1-4 , as a further solution of the present invention, the Eustachian tube stent 1 is made of a nitinol tube and has an hourglass-shaped double-cone structure.

[0027] The stent is manufactured by processing a nitinol tube. The outer diameter of the tube is 1 - 2 mm, and the wall thickness is 0.15 - 0.35 mm. The memory shape of the stent is like an hourglass, with large ends and a thin middle. One of the two ends is larger, with an outer diameter of 6 - 9 mm and a length of 6 - 12 mm. The other end is smaller, with an outer diameter of 3 - 4 mm and a length of 5 - 8 mm. The outer diameter of the thin waist is 1 - 2 mm. The two ends are square bands, and the waist is a diamond grid. The number of square bands at the two ends can be 6 or 8, and the width of the square band is 0.15 - 0.35 mm. The entire stent is 25 - 35 mm long.

[0028] In one embodiment, please refer to the accompanying specification Figures 1-4 , as a further solution of the present invention, a trigger 23 is rotatably connected to the inside of the housing 21, and the right end of the wire pusher 24 is installed inside the trigger 23.

[0029] In one embodiment, please refer to the accompanying specification Figures 1-4, as a further solution of the present invention, both ends of the wire pusher 24 are fixedly connected with ball heads 241, and the size of the ball heads 241 is between the inner diameter of the eustachian tube stent 1 and the inner diameter of the delivery catheter 27.

[0030] In one embodiment, please refer to the attached drawings of the specification Figures 1-4 , as a further solution of the present invention, the delivery catheter 27 is made of medical-grade plastic, and the inner wall of the delivery catheter 27 is smooth and elastic.

[0031] The delivery catheter is made of a plastic tube with a certain elasticity. The plastic tube has a certain hardness and is at 80-110a. It can adapt to the tortuous cavity changes in the delivery environment. The plastic tube is smooth and elastic, and can effectively avoid damaging human tissues during the placement process. There are scales at one end of the catheter near the clamping head stop to assist in positioning the placement position of the stent.

[0032] In one embodiment, please refer to the attached drawings of the specification Figures 1-4 , as a further solution of the present invention, the outside of the clamping head stop 25 is provided with an external thread that matches the internal thread of the housing 21.

[0033] In one embodiment, please refer to the attached drawings of the specification Figures 1-4 , as a further solution of the present invention, a stop head slider 26 is slidably installed on the upper part of the housing 21, and the stop head slider 26 is snap-connected to the clamping head stop 25.

[0034] The shape of the stent fits the eustachian tube structure. The eustachian tube is a duct located between the middle ear and the nasopharynx. The eustachian tube of an adult is about 31-38 mm long, and the eustachian tube of a female is shorter and flatter than that of a male. The three-dimensional model of the eustachian tube is similar to an hourglass. The distal 2 / 3 is the fibrocartilaginous part, and the proximal 1 / 3 is the bony part located in the temporal bone. The junction of the two is the isthmus, and the diameter is 1-2 mm.

[0035] The stent can be pre-placed in the delivery catheter. When the stent is operated and placed, the large head is in the fibrocartilaginous part, the small head is in the temporal bone part, and the narrow waist is in the isthmus.

[0036] The delivery device consists of a handle, a clamping head stop, a stop head slider, a delivery catheter, and a wire pusher.

[0037] The trigger of the handle of the delivery device is connected to the wire pusher. When the trigger is pressed, the wire pusher moves forward to push out the eustachian tube stent pre-placed in the delivery catheter.

[0038] The delivery catheter is made of a plastic tube with a certain elasticity. The plastic tube has a certain hardness and is at 80-110a. It can adapt to the tortuous cavity changes in the delivery environment. The plastic tube is smooth and elastic, and can effectively avoid damaging human tissues during the placement process. There are scales at one end of the catheter near the clamping head stop to assist in positioning the placement position of the stent.

[0039] The pusher wire is a plastic wire or a metal wire with a certain elasticity. It has a certain hardness and can push the stent out of the catheter. There is a certain distance between the distal end of the pusher wire and the distal end of the catheter, and this distance is the same as the length of the stent. The stent can be pre-set in the catheter, and its tail contacts the pusher wire. A ball head can be provided at one end of the pusher wire in contact with the stent, and the size of the ball head is between the inner diameter of the stent and the inner diameter of the catheter.

[0040] The outer periphery of the connecting part of the clamping head is provided with a thread, which is fitted with the inner thread of the head of the handle. By rotating the clamping head, the clamping head can be moved forward. In clinical applications, the operator can adjust the position of the clamping head according to the actual situation of the eustachian tube structure of the patient to lock the placement position of the stent. The clamping head is stuck outside the nasal cavity, and the catheter enters the eustachian tube through the pharyngeal orifice. The distance from the proximal end of the placement position of the eustachian tube stent to the outer orifice of the nostril is the distance from the distal end of the catheter to the clamping head.

[0041] There are grooves on the upper and lower opposite sides of the connecting part of the clamping head. Rotate the head so that the groove and the sliding lock cylinder are in the same plane. Push the sliding lock forward, and the sliding lock cylinder is embedded in the groove of the connecting part of the clamping head. The clamping head will not be able to rotate, that is, it cannot move back and forth.

[0042] The operator holds the delivery device, and the catheter enters the eustachian tube through the nasal cavity and the pharyngeal orifice of the eustachian tube. The otorhinolaryngology endoscope enters from the ear canal to observe the position of the catheter and roughly confirm the placement position of the eustachian tube stent. At this time, use the scale at the tail of the catheter to confirm the distance between the outer orifice of the nostril and the clamping head. Then, rotate the clamping head to move it to the scale where the outer orifice of the nostril was just confirmed. Press the trigger to push out the stent. The stent naturally expands and becomes hourglass-shaped, propping up the cartilaginous part of the eustachian tube and getting stuck in the isthmus, so that the stent will not move due to daily activities of the human body.

[0043] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Eustachian tube support and a transmitter thereof, comprising a Eustachian tube support (1) and a transmitter (2), characterized in that: The transmitter (2) comprises a shell (21), the left end of the shell (2) is spirally connected to a stopper (25), the inner side of the stopper (25) is equipped with a transmitter tube (27), the inner side of the end of the transmitter tube (27) is equipped with a Eustachian tube support (1), and the right side of the Eustachian tube support (1) is provided with a push wire (24).

2. The Eustachian tube support and the device thereof according to claim 1, characterized in that: The Eustachian tube support (1) is made of a nickel-titanium alloy tube and has an hourglass-shaped double-cone structure.

3. The Eustachian tube support and the device thereof according to claim 1, characterized in that: The inner side of the housing (21) is rotatably connected to a trigger (23), and the right end of the push wire (24) is installed on the inner side of the trigger (23).

4. The Eustachian tube support and the device thereof according to claim 1, characterized in that: Both ends of the push wire (24) are fixedly connected with ball heads (241), and the size of the ball head (241) is between the inner diameter of the Eustachian tube support (1) and the inner diameter of the delivery catheter (27).

5. The Eustachian tube support and the device thereof according to claim 1, characterized in that: The delivery catheter (27) is made of medical grade plastics. The inner wall of the delivery catheter (27) is smooth and elastic. A scale is provided on one end of the delivery catheter (27) close to the shell (21).

6. The Eustachian tube support and the device thereof according to claim 1, characterized in that: The exterior of the blocking head (25) is provided with an external thread which matches the internal thread of the housing (21).

7. The Eustachian tube support and the device thereof according to claim 1, characterized in that: A stopper slide lock (26) is slidably mounted on the upper portion of the housing (21), and the stopper slide lock (26) is engaged and connected with the blocking stopper (25).

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