Puncture microneedle device adopting propelling element to assist in precise drug delivery through tympanic chamber of external auditory canal

Abstract

The invention provides an external auditory canal tympanic chamber precise drug delivery puncture microneedle device assisted by a propelling element. The device comprises a long-strip-shaped microneedle element and a long-strip-shaped propelling element. A first protrusion, a second protrusion and a cap-shaped structure are sequentially formed at the front end, inserted into the ear, of the long-strip-shaped microneedle element from the front end to the rear end. Wherein the recess between the first protrusion and the second protrusion is used for limiting the position of the tympanic membrane in a state in which the first protrusion penetrates through the tympanic membrane; a containing groove is formed in the front end of the long-strip-shaped propelling element and used for containing the cap-shaped structure, and therefore the long-strip-shaped microneedle element is controlled to be inserted into the ear through the long-strip-shaped propelling element.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a microneedle device for precise drug delivery and puncture through the tympanic cavity of the external auditory canal assisted by a propulsion element. Background Art

[0002] At present, local treatment of inner ear diseases (such as deafness, tinnitus, vertigo, etc.) in clinical practice is mostly carried out by tympanic administration. Tympanic administration is a method of local treatment of inner ear diseases, mainly used in otology, especially for deafness, tinnitus and vertigo. This method directly delivers the drug to the tympanic cavity of the middle ear, allowing the drug to penetrate the round window membrane or oval window membrane, and then enter the perilymph of the inner ear, directly affecting the cochlea and vestibular organs.

[0003] There is no puncture needle designed specifically for tympanic drug delivery on the market. Therefore, it is desirable to develop a novel puncture needle device for tympanic drug delivery via the external auditory canal. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element in view of the above-mentioned defects in the prior art, which is easy to operate and can achieve precise drug delivery.

[0005] According to the present invention, there is provided a microneedle device for precise drug delivery through the external auditory canal and tympanic cavity, comprising: an elongated microneedle element and an elongated propulsion element; wherein, at the front end of the elongated microneedle element inserted into the ear, a first protrusion, a second protrusion and a cap-like structure are formed in sequence from the front end to the rear end; wherein, the cross-sectional area of ​​the first protrusion gradually decreases in the direction from the back to the front so as to penetrate the tympanic membrane, and the recessed portion between the first protrusion and the second protrusion is used to limit the position of the tympanic membrane when the first protrusion penetrates the tympanic membrane; a receiving groove is formed at the front end of the elongated propulsion element for accommodating the cap-like structure, so that the insertion of the elongated microneedle element into the ear is controlled by the elongated propulsion element.

[0006] Preferably, the cap-like structure is a sheet-like structure, wherein the side facing the rear end of the elongated microneedle element is a vertical side, and the accommodating groove is formed as two parallel wings arranged at the front end of the elongated propulsion element, and the space between the two wings matches the sheet-like structure of the cap-like structure, so that during operation, the elongated propulsion element accommodates the cap-like structure in the accommodating groove, and the front end of the elongated propulsion element presses against the vertical side of the cap-like structure in the accommodating groove to control the movement of the elongated microneedle element.

[0007] Preferably, the thickness of the cap-like structure is equal to the distance between the two flaps.

[0008] Preferably, the microneedle device for precise drug delivery and puncture through the external auditory canal tympanic cavity assisted by a propulsion element further includes: a foldable fixing wing located in the ear canal area of ​​the elongated microneedle element when the first protrusion penetrates the eardrum, for fixing the position of the elongated microneedle element in the ear canal.

[0009] Preferably, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to a preferred embodiment of the present invention further includes: a control element arranged at the rear end of the elongated microneedle element for controlling the opening and folding of the foldable fixed wings.

[0010] Preferably, the microneedle device for precise drug delivery and puncture through the tympanic cavity of the external auditory canal assisted by a propulsion element also includes: a forked double-branch structure located at the rear end of the elongated propulsion element, wherein the forked double-branch structure includes a three-way pipe, a first drug delivery unit and a second drug delivery unit, and the three openings of the three-way pipe are respectively connected to the main pipe of the elongated propulsion element, the first drug delivery unit and the second drug delivery unit.

[0011] Preferably, the rear end of the elongated propulsion element is provided with a handle which is angled with respect to the body of the elongated propulsion element.

[0012] Preferably, the length from the notch to the handle of the elongated pushing element is greater than the length from the second protrusion to the bifurcated double-branch structure of the elongated microneedle element.

[0013] Preferably, the first protrusion has a cross-sectional area that gradually decreases in a direction from back to front so as to penetrate the eardrum.

[0014] Preferably, the outer diameter of the main tube of the elongated microneedle element is in the range of 0.1 to 0.5 mm, and the inner diameter is in the range of 0.05 to 0.3 mm; the material of the elongated microneedle element is medical plastic or medical silicone; the material of the elongated propulsion element is medical hard plastic or stainless steel metal material, and the length of the main tube of the elongated microneedle element is in the range of 4.5 to 10 centimeters.

[0015] The present invention adopts an ultra-fine microneedle with two rib protrusions at the front end and a cap-shaped structure, and is matched with a push rod specially designed for microneedle implantation. The front end of the push rod has a receiving groove matching the cap-shaped structure, and a foldable fixing wing is added to the ear canal area of ​​the microneedle for fixing the relative position in the ear canal, and a bifurcated double-branch structure is set at the tail end of the microneedle to connect different drug delivery syringes, micropumps, drug delivery balloons, etc.

[0016] The invention is easy to operate, easy to fix, and has no adverse reactions such as obvious discomfort, which greatly improves the patient's compliance and the accuracy of sustained-release targeted drug delivery. At the same time, the invention has a low production cost and is suitable for large-scale production and promotion and application.

[0017] The invention is particularly suitable for local administration through the external auditory canal tympanic cavity, and has good application prospects and economic benefits for treating inner ear diseases such as deafness, tinnitus and vertigo. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] A more complete understanding of the present invention and its attendant advantages and features will be more readily appreciated by reference to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0019] Figure 1 The overall schematic diagram of the microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to a preferred embodiment of the present invention is schematically shown.

[0020] It should be noted that the drawings are used to illustrate the present invention, rather than to limit the present invention. Note that the drawings showing the structures may not be drawn to scale. In addition, in the drawings, the same or similar elements are marked with the same or similar reference numerals. DETAILED DESCRIPTION

[0021] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0023] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0024] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0025] Figure 1 The overall schematic diagram of the microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to a preferred embodiment of the present invention is schematically shown.

[0026] like Figure 1 As shown, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to a preferred embodiment of the present invention comprises: an elongated microneedle element 10 and an elongated propulsion element 20.

[0027] Among them, the front end of the long microneedle element 10 inserted into the ear is sequentially formed with a first protrusion 11, a second protrusion 12 and a cap-like structure 13 from the front end (ear entry end) to the rear end (hand-held end), wherein the cross-sectional area of ​​the first protrusion 11 gradually decreases in the direction from back to front so as to penetrate the tympanic membrane, and the recessed portion between the first protrusion 11 and the second protrusion 12 is used to limit the position of the tympanic membrane when the first protrusion 11 penetrates the tympanic membrane.

[0028] A receiving groove 21 is formed at the front end of the elongated pushing element 20 for receiving the cap-shaped structure 13 , so that the insertion of the elongated microneedle element 10 into the ear is controlled by the elongated pushing element 20 .

[0029] Preferably, the cap-like structure 13 is a sheet-like structure, wherein the side facing the rear end (hand-held end) of the elongated microneedle element 10 is a vertical side, and the receiving groove 21 is formed as two parallel wings arranged at the front end of the elongated propulsion element 20, and the space between the two wings matches the sheet-like structure of the cap-like structure 13. For example, Figure 1 As shown, the cap-like structure 13 is a fan-shaped sheet structure, and one right-angled side of the fan-shaped sheet structure faces the rear end (hand-held end) of the long strip microneedle element 10. In this way, during operation, the long strip propulsion element 20 accommodates the cap-like structure 13 in the receiving groove 21, and the front end of the long strip propulsion element 20 supports the vertical side of the cap-like structure 13 in the receiving groove 21, thereby controlling the movement of the long strip microneedle element 10.

[0030] Preferably, the thickness of the cap-like structure 13 is equal to the distance between the two wings.

[0031] Preferably, if Figure 1 As shown, according to a preferred embodiment of the present invention, the microneedle device for precise drug delivery and puncture through the external auditory canal tympanic cavity using a propulsion element as an aid also includes: a foldable fixing wing 14 located in the ear canal area of ​​the elongated microneedle element 10 when the first protrusion 11 penetrates the eardrum, which is used to fix the position of the elongated microneedle element 10 in the ear canal.

[0032] Preferably, the microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to a preferred embodiment of the present invention further comprises: a control element (not specifically shown) arranged at the rear end (handheld end) of the elongated microneedle element 10 for controlling the opening and folding of the foldable fixing wings 14. Thus, when it is determined that the predetermined position in the ear canal has been reached, the foldable fixing wings 14 can be opened to fix the position of the elongated microneedle element 10 in the ear canal.

[0033] Furthermore, preferably, Figure 1 As shown, according to a preferred embodiment of the present invention, the microneedle device for precise drug delivery and puncture through the tympanic cavity of the external auditory canal using the assistance of a propulsion element also includes: a forked double-branch structure 15 located at the rear end (handheld end) of the elongated propulsion element 20, wherein the forked double-branch structure 15 includes a three-way pipe 16, a first drug delivery unit 17 and a second drug delivery unit 18, and the three openings of the three-way pipe 16 are respectively connected to the main pipe 19 of the elongated propulsion element 20, the first drug delivery unit 17 and the second drug delivery unit 17.

[0034] Preferably, if Figure 1 As shown, the rear end (hand-held end) of the elongated propulsion element 20 is provided with a handle 22 which is angled with the main body of the elongated propulsion element 20 to facilitate propulsion operation.

[0035] Preferably, the length from the recess 21 to the handle 22 of the elongated propulsion element 20 is greater than the length from the second protrusion 12 to the bifurcated double-branch structure 15 of the elongated microneedle element 10, thereby allowing the user to operate the elongated propulsion element 20 more freely.

[0036] Preferably, the outer diameter of the microneedle body (main tube 19 of the long strip microneedle element 10) is in the range of 0.1 to 0.5 mm, and the inner diameter is in the range of 0.05 to 0.3 mm, that is, an ultrafine microneedle. The material of the long strip microneedle element 10 is, for example, medical plastic or medical silica gel; the material of the long strip propulsion element 20 is, for example, medical hard plastic or stainless steel metal material, and the length of the main tube of the long strip microneedle element is in the range of 4.5 to 10 cm.

[0037] The present invention adopts an ultra-fine microneedle with two rib protrusions at the front end and a cap-shaped structure, and is matched with a push rod specially designed for microneedle implantation. The front end of the push rod has a receiving groove matching the cap-shaped structure, and a foldable fixing wing is added to the ear canal area of ​​the microneedle for fixing the relative position in the ear canal, and a bifurcated double-branch structure is set at the tail end of the microneedle to connect different drug delivery syringes, micropumps, drug delivery balloons, etc.

[0038] The invention is easy to operate, easy to fix, and has no adverse reactions such as obvious discomfort, which greatly improves the patient's compliance and the accuracy of sustained-release targeted drug delivery. At the same time, the invention has a low production cost and is suitable for large-scale production and promotion and application.

[0039] The invention is particularly suitable for local administration through the external auditory canal tympanic cavity, and has good application prospects and economic benefits for treating inner ear diseases such as deafness, tinnitus and vertigo.

[0040] In addition, it should be noted that, unless otherwise specified, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0041] It is to be understood that, although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still falls within the scope of protection of the technical solution of the present invention.

Claims

1. A microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element, characterized in that include: An elongated microneedle element and an elongated propulsion element; wherein, at the front end of the elongated microneedle element inserted into the ear, a first protrusion, a second protrusion and a cap-like structure are formed in sequence from the front end to the rear end; wherein, the recessed portion between the first protrusion and the second protrusion is used to limit the position of the tympanic membrane when the first protrusion penetrates the tympanic membrane; a receiving groove is formed at the front end of the elongated propulsion element for receiving the cap-like structure, so that the insertion of the elongated microneedle element into the ear is controlled by the elongated propulsion element.

2. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1, characterized in that: The cap-like structure is a sheet-like structure, in which the side facing the rear end of the elongated microneedle element is a vertical side, and the receiving groove is formed as two parallel wings arranged at the front end of the elongated propulsion element, and the space between the two wings matches the sheet-like structure of the cap-like structure, so that during operation, the elongated propulsion element accommodates the cap-like structure in the receiving groove, and the front end of the elongated propulsion element presses against the vertical side of the cap-like structure in the receiving groove to control the movement of the elongated microneedle element.

3. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that: The thickness of the cap-like structure is equal to the distance between the two flaps.

4. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that: The first protrusion gradually decreases in cross-sectional area in a direction from back to front so as to penetrate the eardrum.

5. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that It also includes: a foldable fixing wing located in the ear canal area of ​​the elongated microneedle element when the first protrusion penetrates the eardrum, and is used to fix the position of the elongated microneedle element in the ear canal.

6. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 5, characterized in that The invention also comprises: a control element arranged at the rear end of the long strip-shaped microneedle element and used for controlling the opening and folding of the foldable fixed wings.

7. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that It also includes: a forked double-branch structure located at the rear end of the long strip propulsion element, wherein the forked double-branch structure includes a three-way pipe, a first dosing unit and a second dosing unit, and the three openings of the three-way pipe are respectively connected to the main pipe of the long strip propulsion element, the first dosing unit and the second dosing unit.

8. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that: The rear end of the elongated propulsion element is provided with a handle which is angled with the main body of the elongated propulsion element.

9. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that: The length from the notch to the handle of the elongated pushing element is greater than the length from the second protrusion to the bifurcated double-branch structure of the elongated microneedle element.

10. The microneedle device for precise drug delivery through the external auditory canal tympanic cavity assisted by a propulsion element according to claim 1 or 2, characterized in that: The outer diameter of the main tube of the elongated microneedle element is in the range of 0.1 to 0.5 mm, and the inner diameter is in the range of 0.05 to 0.3 mm; the material of the elongated microneedle element is medical plastic or medical silicone; the material of the elongated propulsion element is medical hard plastic or stainless steel metal material, and the length of the main tube of the elongated microneedle element is in the range of 4.5 to 10 centimeters.

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