Flow-adjustable tympanic cavity administration capillary puncture microneedle

Abstract

The invention relates to the technical field of medical instruments, and discloses a flow-adjustable tympanic cavity administration capillary puncture microneedle which comprises an administration tube and a guide core. The dosing tube comprises a puncture part, an infusion part and a limiting part located at the far end of the infusion part, the puncture part partially extends into the infusion part and is communicated with an inner cavity of the infusion part through the connecting port, the puncture part is used for puncturing the tympanic membrane, and the limiting part is used for abutting against the outer surface of the tympanic membrane. The guiding core body is partially located in the inner cavity of the infusion part and is suitable for rotating around the center axis of the infusion part in the first direction to the end to gradually block the connecting opening or rotating in the second direction opposite to the first direction to the end to be gradually away from the connecting opening. Compared with a traditional puncture microneedle, the puncture microneedle provided by the invention can accurately adjust the administration flow and control the administration amount. Meanwhile, the device is simple in structure, low in material cost and suitable for large-scale production, popularization and application.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a capillary puncture micro needle for tympanic cavity drug delivery with adjustable flow rate. Background Art

[0002] At present, for the local treatment of inner ear diseases such as deafness, tinnitus, and dizziness in clinical practice, the tympanic cavity drug delivery method is mostly adopted. There is no dedicated puncture micro needle designed for tympanic cavity drug delivery on the market. Due to the difference in the depth of the ear canals of different patients, it is not convenient to judge the depth of insertion into the tympanic cavity with a conventional puncture micro needle, and it is impossible to accurately control the drug dosage, which is likely to cause adverse reactions in patients. Summary of the Invention

[0003] In view of this, the present invention provides a capillary puncture micro needle for tympanic cavity drug delivery with adjustable flow rate to solve the problems that a conventional puncture micro needle cannot accurately control the drug delivery position and dosage, and is likely to cause adverse reactions in patients.

[0004] The present invention provides a capillary puncture micro needle for tympanic cavity drug delivery with adjustable flow rate, including:

[0005] A drug delivery tube, including a puncture part, an infusion part, and a limiting part located at the distal end of the infusion part. The puncture part partially extends into the infusion part and is communicated with the inner cavity of the infusion part through a connection port. Among them, the puncture part is used for puncturing the tympanic membrane, and the limiting part is used for abutting against the outer surface of the tympanic membrane;

[0006] A guiding core body, partially located in the inner cavity of the infusion part, and adapted to rotate around the central axis of the infusion part in a first direction so that the end gradually blocks the connection port, or rotate in a second direction opposite to the first direction so that the end gradually moves away from the connection port.

[0007] Optionally, the guiding core body includes a core rod rotatably arranged in the infusion part, and a rotating head connected to the core rod and in threaded cooperation with the proximal end of the infusion part.

[0008] Optionally, a catheter seat is provided at the proximal end of the infusion part. The first cavity of the catheter seat is coaxially arranged with the infusion part. The rotating head is partially located in the catheter seat and is in threaded cooperation with the catheter seat; a handle is provided on the catheter seat.

[0009] Optionally, the radial dimension of the rotating head is greater than the radial dimension of the catheter seat.

[0010] Optionally, an indicating member is provided on the proximal end surface of the rotating head. The indicating member is used to indicate the relative angle between the rotating head and the catheter seat and the rotation angle.

[0011] Optionally, the connection port is a flared opening facing the proximal end of the infusion part, and the end of the guiding core gradually blocks the connection port when moving towards the connection port.

[0012] Optionally, the end of the guiding core is a plug, and the surface of the plug facing the connection port is an arc surface.

[0013] Optionally, the puncturing part is a capillary micro needle, the infusion part is a cannula needle, and the radial dimension of the cannula needle is greater than that of the capillary micro needle.

[0014] Optionally, the limiting part is a retaining piece sleeved on the capillary micro needle and close to the distal end of the infusion part.

[0015] Optionally, a retaining block is arranged on the cannula needle and abuts against the retaining piece.

[0016] Beneficial effects:

[0017] The adjustable-flow tympanic cavity drug delivery capillary puncture micro needle provided by the present invention includes: a drug delivery tube and a guiding core. The drug delivery tube includes a puncturing part, an infusion part, and a limiting part located at the distal end of the infusion part. The puncturing part partially extends into the infusion part and is communicated with the inner cavity of the infusion part through a connection port. Among them, the puncturing part is used for puncturing the eardrum, and the limiting part is used for abutting against the outer surface of the eardrum. The guiding core is partially located in the inner cavity of the infusion part and is adapted to rotate around the central axis of the infusion part in a first direction until the end gradually blocks the connection port, or rotate in a second direction opposite to the first direction until the end gradually moves away from the connection port.

[0018] During use, the drug delivery tube can be inserted into the ear canal. During this process, the puncturing part will penetrate the eardrum until the limiting part abuts against the outer surface of the eardrum, thereby limiting the puncturing depth of the puncturing part, and the abutment of the limiting part against the eardrum can prevent the puncturing part from shaking. Then, the guiding core can be rotated in the second direction until its distal end is separated from the connection port, so as to conduct the inner cavities of the puncturing part and the infusion part, facilitating drug delivery to the tympanic cavity through the infusion part and the puncturing part. During this process, the guiding core can be rotated in the first direction or the second direction to adjust the gap between the distal end of the guiding core and the connection port, thereby controlling the flow rate. After reaching the predetermined drug delivery amount, the guiding core can be rotated in the first direction until its distal end blocks the connection port to control the drug amount. In addition, the guiding core can also play a role in supporting and boosting, facilitating the puncturing part to accurately penetrate the eardrum in the correct direction.

[0019] Compared with the traditional puncture micro needle, the puncture micro needle provided by the present invention can accurately control the penetration depth of the puncturing part, ensure that the puncturing part does not shake, and can accurately adjust the drug delivery flow rate and control the drug delivery amount. At the same time, the structure provided by the present invention is simple, the material cost is low, and it is suitable for large-scale production and popularization and application. Description of the drawings

[0020] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are 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.

[0021] Figure 1 Structural schematic diagram of the adjustable-flow tympanic cavity drug delivery capillary puncture microneedle according to an embodiment of the present invention;

[0022] Figure 2 For Figure 1 Structural schematic diagram of the mating state of the guiding core and the connection port shown;

[0023] Figure 3 For Figure 1 Structural schematic diagram of the rotation angle of the rotating head shown.

[0024] Explanation of reference numerals:

[0025] 11. Puncture part; 12. Infusion part; 121. Flank; 13. Connection port; 21. Limiting part; 22. Block; 31. Core rod; 311. Plug; 32. Rotating head; 321. Indicator; 4. Catheter seat; 41. First cavity; 42. Second cavity; 43. Liquid inlet pipe; 44. Connector; 5. Handle. Specific embodiments

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.

[0027] Such as Figure 1As shown in the figure, this embodiment provides a tympanic cavity drug delivery capillary puncture microneedle with adjustable flow rate, including: a drug delivery tube and a guiding core. The drug delivery tube includes a puncture part 11 and an infusion part 12, and a limiting part 21 located at the distal end of the infusion part 12. The puncture part 11 partially extends into the infusion part 12 and communicates with the inner cavity of the infusion part 12 through a connection port 13. Among them, the puncture part 11 is used for puncturing the eardrum, and the limiting part 21 is used for abutting against the outer surface of the eardrum. The guiding core is partially located in the inner cavity of the infusion part 12 and is adapted to rotate around the central axis of the infusion part 12 in a first direction until the end gradually blocks the connection port 13, or rotate in a second direction opposite to the first direction until the end gradually moves away from the connection port 13. One of the first direction and the second direction is the clockwise direction, and the other is the counterclockwise direction.

[0028] During use, the drug delivery tube can be inserted into the ear canal. During this process, the puncture part 11 will penetrate the eardrum until the limiting part 21 abuts against the outer surface of the eardrum, thereby limiting the puncture depth of the puncture part 11, and the abutment of the limiting part 21 against the eardrum can prevent the puncture part 11 from shaking. Then, the guiding core can be rotated in the second direction until its distal end is separated from the connection port 13, so as to conduct the inner cavities of the puncture part 11 and the infusion part 12, facilitating drug delivery to the tympanic cavity through the infusion part 12 and the puncture part 11. During this process, the guiding core can be rotated in the first direction or the second direction to adjust the gap between the distal end of the guiding core and the connection port 13, thereby controlling the flow rate. After reaching the predetermined drug dosage, the guiding core can be rotated in the first direction until its distal end blocks the connection port 13 to control the drug dosage. In addition, the guiding core can also play a role in supporting and boosting, facilitating the puncture part 11 to accurately penetrate the eardrum in the correct direction.

[0029] Compared with the traditional puncture microneedle, the puncture microneedle provided by the present invention can accurately control the penetration depth of the puncture part 11, ensure that the puncture part 11 does not shake, and can accurately adjust the drug delivery flow rate and control the drug dosage. At the same time, the structure provided by the present invention is simple, the material cost is low, and it is suitable for large-scale production and popularization and application.

[0030] In this embodiment, the proximal end and the distal end are defined according to the distance of the structure from the operator. The end farther from the operator is defined as the distal end, and the end closer to the operator is the proximal end.

[0031] As Figure 1As shown in the figure, in this embodiment, the guiding core includes a core rod 31 rotatably arranged in the infusion part 12, and a rotating head 32 connected to the core rod 31 and threadedly engaged with the proximal end of the infusion part 12. For example, internal threads are provided at the proximal end of the infusion part 12, and external threads are provided on the part of the rotating head 32 extending into the infusion part 12. By the cooperation of the internal and external threads, the distal end of the core rod 31 can be controlled to move towards or away from the connection port 13. By rotating the rotating head 32, it is convenient for the operator to control the movement of the core rod 31 in the infusion part 12 to block or open the connection port 13. In addition, the flow area can be controlled by controlling the gap between the end of the core rod 31 and the connection port 13, thereby controlling the flow rate. In addition, a seal, such as an O-ring, adapted to the size of the core rod 31 can be provided at the proximal end of the infusion part 12, so as to ensure the unobstructed sliding of the core rod 31 and prevent liquid from flowing out of the distal end of the infusion part 12.

[0032] As Figure 1 shown in the figure, in this embodiment, a catheter seat 4 is provided at the proximal end of the infusion part 12. The first cavity 41 of the catheter seat 4 is coaxially arranged with the infusion part 12. The rotating head 32 is partially located in the catheter seat 4 and is threadedly engaged with the catheter seat 4. The guiding inner core extends into the inner cavity of the infusion part 12 from the first cavity 41. For example, internal threads are provided on the inner wall of the proximal end of the first cavity 41 of the catheter seat 4, and external threads are provided on the part of the rotating head 32 extending into the first cavity 41. By the cooperation of the internal and external threads, the distal end of the core rod 31 can be controlled to move towards or away from the connection port 13. The O-ring can be coaxially and fixedly arranged at a position close to the proximal end in the first cavity 41 and sleeved on the core rod 31.

[0033] As Figure 1 shown in the figure, in this embodiment, the catheter seat 4 further includes a second cavity 42 connected to the side wall of the first cavity 41. Fluids can enter the second cavity 42, the first cavity 41, and the infusion part 12 in sequence, and then enter the tympanic cavity of the patient through the infusion part 12, the connection port, and the puncture part 11. The O-ring can be located between the communication part of the second cavity 42 and the first cavity 41 and the proximal end of the first cavity 41.

[0034] As Figure 1 shown in the figure, in this embodiment, there is a gap between the outer wall of the guiding inner core and the inner walls of the first cavity 41 and the infusion part 12, that is, there is a gap between the core rod 31 and the inner walls of the first cavity 41 and the infusion part 12. This gap is beneficial to the flow of liquids. The throttling or flow rate control can be achieved by the cooperation of the plug 311 of the core rod 31 and the connection port 13.

[0035] As Figure 1 shown in the figure, in this embodiment, the second cavity 42 is connected to a joint 44 through a liquid inlet pipe 43. The joint 44 can be connected to an external liquid supply device, such as a drug injection syringe, a micropump, and a drug balloon.

[0036] As Figure 1 shown, in this embodiment, the radial dimension of the rotating head 32 is larger than that of the catheter seat 4, thereby preventing the rotating head 32 from entering the inner cavity of the infusion part 12.

[0037] As Figure 1 , Figure 2 and Figure 3 shown, in this embodiment, an indicating member 321 is provided on the proximal end surface of the rotating head 32. The indicating member 321 is used to indicate the relative angle between the rotating head 32 and the catheter seat 4, as well as the rotation angle. For example, at the angle shown in Figure 3 , when the rotating head 32 rotates clockwise, the indicating member 321 rotates synchronously, and the plug 311 of the core rod 31 moves away from the connection port 13. On the contrary, when the rotating head 32 rotates counterclockwise, the indicating member 321 rotates synchronously, and the plug 311 of the core rod 31 moves closer to the connection port 13. Since there is a corresponding relationship between the rotation angle or the indicating direction of the indicating member 321 and the distance between the plug 311 and the connection port 13, the flow rate can be controlled by the rotation angle or the indicating direction of the indicating member 321, thereby achieving the purpose of accurately controlling the flow rate.

[0038] As Figure 1 shown, in this embodiment, the connection port 13 is a flared opening facing the proximal end of the infusion part 12. That is, the size of the connection port 13 gradually increases from the puncture part 11 to the infusion part 12. When the end of the guiding core moves towards the connection port 13, the connection port 13 is gradually blocked. Such a setting is more conducive to increasing the contact area between the core rod 31 and the inner wall of the connection port, and is more conducive to controlling the flow rate.

[0039] As Figure 1 shown, in this embodiment, the end of the guiding core is a plug 311, and the surface of the plug 311 facing the connection port 13 is an arc surface. For example, the shape of the connection port 13 can be circular, and the surface of the plug 311 facing the connection port can be spherical. The plugging can be achieved by the contact and cooperation between the spherical surface and the inner wall surface of the connection port, or the gap size between the spherical surface and the inner wall of the connection port can be changed to control the flow rate.

[0040] As Figure 1 shown, in this embodiment, a handle 5 is provided on the catheter seat 4. The handle 5 is located between the proximal openings of the second cavity 42 and the first cavity 41, is integrally arc-shaped, and the size gradually increases from the end close to the catheter seat 4 to the end far from the catheter seat 4. Such a setting position avoids the second cavity 42 and the first cavity 41, and at the same time is convenient for medical staff to hold.

[0041] As Figure 1As shown, in this embodiment, the puncture part 11 is a capillary microneedle, and the infusion part 12 is a trocar. The radial dimension of the trocar is larger than that of the capillary microneedle. The trocar is mainly used to transport liquids, and the capillary microneedle is mainly used to puncture the tympanic membrane and introduce the liquid in the trocar into the tympanic cavity. Puncturing the tympanic membrane only by the capillary microneedle can greatly reduce the patient's discomfort, and the wound on the tympanic membrane is small, which is conducive to the self-healing of the tympanic membrane and reduces the probability of complications. The materials of the capillary microneedle and the trocar can be medical plastics, and the two can be integrally formed.

[0042] The length of the trocar can be in the range of 4.5 cm to 10 cm, which can adapt to the ear canal depth of most patients, and the length of the capillary microneedle can be in the range of 2 mm to 4 mm, which can adapt to the drug delivery site of most patients. The inner diameter of the trocar ranges from 100 μm to 500 μm, and the outer diameter ranges from 200 μm to 700 μm, and the inner diameter of the capillary microneedle ranges from 20 μm to 30 μm, and the outer diameter ranges from 40 μm to 100 μm.

[0043] like Figure 1 As shown, in the present embodiment, the limiting portion 21 is a baffle which is sleeved on the capillary microneedle and close to the distal end of the infusion portion 12. The baffle may be circular in shape and may be made of a flexible material. The radius of the baffle may be 1.8 mm to 2.2 mm, so that it may be stably in contact with the patient's tympanic membrane and provide stable support to prevent the capillary microneedle from shaking.

[0044] like Figure 1 As shown, in this embodiment, a stopper 22 is provided on the trocar, which is in close contact with the baffle. Since the baffle is made of a flexible material, the stopper 22 is used to limit the baffle to prevent the baffle from extending into the tympanic membrane due to deformation. The thickness of the stopper 22 can be greater than the thickness of the baffle, thereby ensuring that the baffle is in close contact with the tympanic membrane, and further ensuring that the baffle can be stably supported on the tympanic membrane.

[0045] like Figure 1 As shown, in this embodiment, side wings 121 are provided on the outer wall of the infusion part 12, and the two side wings are relatively arranged on the outer wall of the infusion part 12. The side wings 121 can be folded to fit on the outer wall of the infusion part 12 or unfolded to be perpendicular to the outer wall of the infusion part 12. A control member transmission-connected to the side wings 121 can be provided on the catheter seat 4, and the side walls can be fitted or unfolded by the control member. Therefore, after the infusion part 12 is extended to a predetermined depth, the infusion part 12 can be fixed in the ear canal by unfolding the side wings 121, thereby further improving the stability of the puncture part 11 and the infusion part 12.

[0046] Although embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations fall within the scope defined by the appended claims.

Claims

1. A tympanic capillary puncture microneedle with adjustable flow rate, characterized in that: include: A drug delivery tube, comprising a puncture portion (11) and an infusion portion (12), and a limiting portion (21) located at the distal end of the infusion portion (12), wherein the puncture portion (11) partially extends into the infusion portion (12) and is connected to the inner cavity of the infusion portion (12) through a connecting port (13), wherein the puncture portion (11) is used to puncture the eardrum, and the limiting portion (21) is used to abut against the outer surface of the eardrum; The guide core is partially located in the inner cavity of the infusion part (12), and is suitable for rotating around the central axis of the infusion part (12) in a first direction until the end gradually blocks the connection port (13), or rotating in a second direction opposite to the first direction until the end gradually moves away from the connection port (13).

2. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 1, characterized in that: The guide core body comprises a core rod (31) rotatably arranged in the infusion part (12), and a rotating head (32) connected to the core rod (31) and threadably matched with the proximal end of the infusion part (12).

3. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 2, characterized in that: A catheter seat (4) is provided at the proximal end of the infusion part (12); a first cavity (41) of the catheter seat (4) is coaxially arranged with the infusion part (12); a portion of the rotating head (32) is located inside the catheter seat (4) and is threadedly engaged with the catheter seat (4); and a handle (5) is provided on the catheter seat (4).

4. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 3, characterized in that: The radial dimension of the rotating head (32) is greater than the radial dimension of the catheter seat (4).

5. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 3, characterized in that: The proximal end surface of the rotating head (32) is provided with an indicator (321), and the indicator (321) is used to indicate the relative angle between the rotating head (32) and the catheter seat (4), as well as the rotation angle.

6. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 2, characterized in that: The connection port (13) is an expanded port toward the proximal end of the infusion portion (12), and the end of the guide core gradually blocks the connection port (13) when moving toward the connection port (13).

7. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 6, characterized in that: The end of the guide core is a plug (311), and the surface of the plug (311) facing the connection port (13) is a curved surface.

8. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to any one of claims 1 to 7, characterized in that: The puncture part (11) is a capillary microneedle, and the infusion part (12) is a trocar needle. The radial dimension of the trocar needle is greater than the radial dimension of the capillary microneedle.

9. The tympanic capillary puncture microneedle with adjustable flow rate for drug delivery according to claim 8, characterized in that: The limiting portion (21) is a baffle which is sleeved on the capillary microneedle and is close to the distal end of the infusion portion (12).

10. The tympanic cavity drug delivery capillary puncture microneedle with adjustable flow rate according to claim 9, characterized in that: The trocar is provided with a stopper (22) which is in close contact with the stopper.

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