Capillary puncture microneedle for tympanic administration

By designing capillary puncture microneedles for tympanic administration, including puncture, infusion and limiting parts, the problems of inaccurate and unstable puncture in the prior art are solved, and precise control and safe drug delivery are achieved.

CN120053189APending Publication Date: 2025-05-30BEIJING ANZHEN HOSPITAL AFFILIATED TO CAPITAL MEDICAL UNIV
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Patent Information

Application Number
CN202510067176.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-15
Publication Date
2025-05-30

AI Technical Summary

Technical Problem

The existing puncture microneedles cannot be accurately administered during tympanic administration, and their instability can easily cause adverse reactions in patients.

Method used

A capillary puncture microneedle including a puncture part, an infusion part and a limiting part is designed. The puncture part is used to puncture the eardrum, and the limiting part is used to abut against the outer surface of the eardrum, and the guide core can slide the connection port to control the dosage.

Benefits of technology

Accurate control of the depth of the puncture part is achieved, shaking is avoided, and the accuracy and safety of drug delivery is ensured. At the same time, the structure is simple and the material cost is low, making it suitable for large-scale production.

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Abstract

The invention relates to the technical field of medical instruments, and discloses a capillary puncture microneedle for tympanic administration, which comprises an administration tube and a guide core body. The dosing tube comprises a puncture part, a transfusion part and a limiting part located between the puncture part and the transfusion part, an inner cavity of the puncture part is communicated with an inner cavity of the transfusion part through a 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. And the guide core body extends from the near end of the inner cavity of the infusion part and slides towards the far end until the connector is blocked. Compared with a traditional puncture microneedle, the puncture microneedle can accurately control the stretching depth of the puncture part, it is guaranteed that the puncture part does not shake, and the dosage can be accurately controlled. Meanwhile, the device is simple in structure, low in material cost and suitable for large-scale production, popularization and application.
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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 administration. Background Art

[0002] At present, for the local treatment of inner ear diseases such as deafness, tinnitus, and vertigo in clinical practice, the tympanic cavity drug administration method is mostly adopted. There is no puncture micro needle specifically designed for tympanic cavity drug administration 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 accurate drug administration cannot be achieved. Moreover, after the puncture needle is inserted into the tympanic cavity, it will shake, 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 administration to solve the problems that a conventional puncture micro needle cannot accurately administer drugs and is unstable during tympanic cavity drug administration, which is likely to cause adverse reactions in patients.

[0004] The present invention provides a capillary puncture micro needle for tympanic cavity drug administration, including:

[0005] A drug delivery tube, including a puncture part, an infusion part, and a limiting part located between the puncture part and the infusion part. The inner cavities of the puncture part and the infusion part are communicated through a connection port. Among them, the puncture part is used for puncturing the eardrum, and the limiting part is used for abutting against the outer surface of the eardrum;

[0006] A guiding core body, which extends into the proximal end of the inner cavity of the infusion part and slides distally to block the connection port.

[0007] Optionally, the guiding core body includes a core rod slidably arranged in the infusion part, and a push head connected to the core rod and located outside the infusion part.

[0008] Optionally, the outer edge size of the push head is greater than or equal to the size of the inner cavity of the infusion part.

[0009] Optionally, the connection port is a flared port facing the infusion part, and the end of the guiding core body gradually blocks the connection port when moving towards the connection port.

[0010] Optionally, the end of the guiding core body is a plug, and the surface of the plug facing the connection port is an arc surface.

[0011] Optionally, the puncture part is a capillary micro needle, the infusion part is a trocar needle, and the radial size of the trocar needle is greater than the radial size of the capillary micro needle.

[0012] Optionally, the limiting part is a retaining piece sleeved at the connection of the capillary micro needle and the trocar needle.

[0013] Optionally, a stop block is provided on the trocar and is in close contact with the stop piece.

[0014] Optionally, a catheter hub is provided at the proximal end of the infusion part. The catheter hub includes a first cavity coaxially connected to the infusion part and a second cavity connected to the side wall of the first cavity. The guiding core extends into the inner cavity of the infusion part from the first cavity; a handle is provided on the catheter hub.

[0015] Optionally, there is a gap between the outer wall of the guiding core and the inner walls of the first cavity and the infusion part.

[0016] Advantageous effects:

[0017] The capillary puncture micro needle for tympanic cavity drug administration provided by the present invention includes: a drug delivery tube and a guiding core. The drug delivery tube includes a puncture part, an infusion part, and a limiting part located between the puncture part and the infusion part. The inner cavities of the puncture part and the infusion part are communicated through a connection port. Wherein, the puncture 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 extends into the inner cavity of the infusion part from the proximal end and slides distally to block the connection port.

[0018] During use, the drug delivery tube can be inserted into the ear canal. During this process, the puncture part will penetrate the eardrum until the limiting part abuts against the outer surface of the eardrum, thereby limiting the puncture depth of the puncture part, and the abutment of the limiting part against the eardrum can prevent the puncture part from shaking. Then, the guiding core can be slid until its distal end is separated from the connection port, so as to conduct the inner cavities of the puncture part and the infusion part, facilitating drug administration to the tympanic cavity through the infusion part and the puncture part. After reaching the predetermined drug dosage, the guiding core can be slid until its distal end blocks the connection port, thereby controlling the drug dosage. In addition, the guiding core can also play a role in supporting and boosting, facilitating the puncture 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 puncture part, ensure that the puncture part does not shake, and can accurately 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. 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 the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0021] Figure 1Schematic structural diagram of the capillary puncture microneedle for tympanic cavity drug delivery according to an embodiment of the present invention;

[0022] Figure 2 is Figure 1 Schematic structural diagram of the guiding core body away from the connection port shown in the figure.

[0023] Explanation of reference numerals:

[0024] 11, puncture part; 12, infusion part; 121, wing; 21, limiting part; 22, stop block; 31, core rod; 311, plug; 32, push head; 4, catheter seat; 41, first cavity; 42, second cavity; 43, liquid inlet pipe; 44, joint; 5, handle. Detailed implementation manners

[0025] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below 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. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0026] As Figure 1 and Figure 2 shown, the capillary puncture microneedle for tympanic cavity drug delivery provided by the present invention includes: a drug delivery tube and a guiding core body. The drug delivery tube includes a puncture part 11 and an infusion part 12, and a limiting part 21 located between the puncture part 11 and the infusion part 12. The inner cavities of the puncture part 11 and the infusion part 12 are communicated through a connection port. Among them, the puncture part 11 is used for puncturing the tympanic membrane, and the limiting part 21 is used for abutting against the outer surface of the tympanic membrane. The guiding core body extends into the inner cavity of the infusion part 12 from the proximal end and slides distally to block the connection port.

[0027] During use, the drug delivery tube can be inserted into the ear canal. During this process, the puncture part 11 will penetrate the tympanic membrane until the limiting part 21 abuts against the outer surface of the tympanic membrane, thereby limiting the puncture depth of the puncture part 11, and the abutment of the limiting part 21 against the tympanic membrane can prevent the puncture part 11 from shaking. Then, the guiding core body can be slid until its distal end is separated from the connection port, 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. After reaching the predetermined drug dosage, the guiding core body can be slid until its distal end blocks the connection port, thereby controlling the drug dosage. In addition, the guiding core body can also play a role in supporting and boosting, facilitating the puncture part 11 to accurately penetrate the eardrum in the correct direction. In addition, the flow area can also be controlled by controlling the gap between the end of the guiding core body and the connection port, thereby controlling the flow rate.

[0028] Compared with traditional puncture microneedles, 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 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.

[0029] In this embodiment, the proximal end and the distal end are defined according to the distance of the structure relative to 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.

[0030] Such as Figure 1 and Figure 2 As shown in the figure, in this embodiment, the guiding core includes a core rod 31 slidably disposed in the infusion part 12, and a push head 32 connected to the core rod 31 and located outside the infusion part 12. By the push head 32, it is convenient for the operator to push the core rod 31 to slide in the infusion part 12 to block or open the connection port. In addition, the flow area can be controlled by controlling the gap between the end of the core rod 31 and the connection port, so as to control the flow rate. In addition, a seal member, 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 that both the smooth sliding of the core rod 31 can be ensured and the liquid can be prevented from flowing out from the distal end of the infusion part 12.

[0031] Such as Figure 1 and Figure 2 As shown in the figure, in this embodiment, the outer edge dimension of the push head 32 is greater than or equal to the inner cavity dimension of the infusion part 12, so as to prevent the push head 32 from entering the inner cavity of the infusion part 12.

[0032] Such as Figure 1 and Figure 2 As shown in the figure, in this embodiment, the connection port is a flared port facing the infusion part 12, that is, the size of the connection port gradually increases from the puncture part 11 to the infusion part 12. When the end of the guiding core moves towards the connection port, the connection port 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.

[0033] Such as Figure 1 and Figure 2 As shown in the figure, in this embodiment, the end of the guiding core is a plug, and the surface of the plug facing the connection port is an arc surface. For example, the shape of the connection port can be circular, and the surface of the plug facing the connection port can be spherical. The plugging can be realized by the contact and cooperation between the spherical surface and the inner wall surface of the connection port, or the flow rate can be controlled by changing the gap size between the spherical surface and the inner wall of the connection port.

[0034] Such as Figure 1 and Figure 2As shown, in this embodiment, the puncturing portion 11 is a capillary micro-needle, and the infusion portion 12 is a cannula. The radial dimension of the cannula is larger than that of the capillary micro-needle. The cannula is mainly used for delivering liquid, and the capillary micro-needle is mainly used for puncturing the eardrum and introducing the liquid in the cannula into the tympanic cavity. Puncturing the eardrum only with the capillary micro-needle can greatly reduce the discomfort of the patient, and the wound on the eardrum is small, which is beneficial to the self-healing of the eardrum and reduces the probability of complications. The materials of the capillary micro-needle and the cannula can be medical plastics, and the two can be integrally formed.

[0035] The length range of the cannula can be 4.5 cm to 10 cm, and this length range can adapt to the ear canal depth of most patients. The length range of the capillary micro-needle can be 2 mm to 4 mm, and this length range can adapt to the drug administration sites of most patients. The inner diameter range of the cannula is 100μm to 500μm, and the outer diameter range is 200μm to 700μm. The inner diameter range of the capillary micro-needle is 20μm to 30μm, and the outer diameter range is 40μm to 100μm.

[0036] As Figure 1 and Figure 2 shown, in this embodiment, the limiting portion 21 is a retaining piece sleeved at the connection of the capillary micro-needle and the cannula. The shape of the retaining piece can be circular. The retaining piece can be made of a flexible material, and the radius of the retaining piece can be 1.8 mm to 2.2 mm. Thus, it can stably abut against the eardrum of the patient and can provide stable support to prevent the capillary micro-needle from shaking.

[0037] As Figure 1 and Figure 2 shown, in this embodiment, a stop block 22 is provided on the cannula and is in close contact with the retaining piece. Since the retaining piece is made of a flexible material, the stop block 22 is used to limit the retaining piece to prevent the retaining piece from deforming and extending into the eardrum. The thickness of the stop block 22 can be greater than the thickness of the retaining piece, so as to ensure that the retaining piece fits on the eardrum, and further ensure that the retaining piece can stably support on the eardrum.

[0038] As Figure 1 and Figure 2As shown, in this embodiment, a catheter seat 4 is provided at the proximal end of the infusion part 12, and the catheter seat 4 includes a first cavity 41 coaxially connected to the infusion part 12, and a second cavity 42 connected to the side wall of the first cavity 41, guiding the core body from the first cavity 41 to extend into the inner cavity of the infusion part 12, and the end of the core rod 31 connected to the push head 32 can partially extend out of the proximal end of the first cavity 41, and the sealing ring can be coaxially fixedly arranged in the first cavity 41 near the proximal end, and sleeved on the core rod 31, and the sealing ring can be located between the connection point between the second cavity 42 and the first cavity 41 and the proximal end of the first cavity 41, so that the fluid can enter the second cavity 42, the first cavity 41 and the infusion part 12 in sequence, and then pass through the infusion part 12, the connecting port and the puncture part 11 until entering the patient's tympanic cavity.

[0039] like Figure 1 and Figure 2 As shown, in this embodiment, there is a gap between the outer wall of the guide 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 conducive to the flow of liquid, and the throttling or flow rate control can be achieved by cooperating with the plug 311 of the core rod 31 and the connecting port.

[0040] like Figure 1 and Figure 2 As shown, in this embodiment, the second cavity 42 is connected to the connector 44 via a liquid inlet tube 43, and the connector 44 can be connected to an external liquid feeding device, such as a drug delivery syringe, a micro pump, and a drug delivery balloon.

[0041] like Figure 1 As shown, in this embodiment, a handle 5 is provided on the catheter seat 4, and the handle 5 is located between the second cavity 42 and the proximal opening of the first cavity 41. The handle 5 is arc-shaped as a whole, and its size gradually increases from the end close to the catheter seat 4 to the end away from the catheter seat 4. Thus, the position is set to avoid the second cavity 42 and the first cavity 41, and at the same time it is convenient for medical staff to hold it.

[0042] 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.

[0043] 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 capillary puncture microneedle for intratympanic drug delivery, characterized in that: include: A drug delivery tube, comprising a puncture portion (11) and an infusion portion (12), and a limiting portion (21) located between the puncture portion (11) and the infusion portion (12), wherein the inner cavities of the puncture portion (11) and the infusion portion (12) are connected via a connecting port, 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 guiding core body extends from the proximal end of the inner cavity of the infusion part (12) and slides toward the distal end to block the connection port.

2. The capillary puncture microneedle for intratympanic drug delivery according to claim 1, characterized in that: The guide core body comprises a core rod (31) slidably arranged in the infusion part (12), and a push head (32) connected to the core rod (31) and located outside the infusion part (12).

3. The capillary puncture microneedle for intratympanic drug delivery according to claim 2, characterized in that: The outer edge size of the pusher head (32) is greater than or equal to the size of the inner cavity of the infusion part (12).

4. The capillary puncture microneedle for intratympanic drug delivery according to claim 2, characterized in that: The connection port is an expanded port toward the infusion part (12), and the end of the guide core gradually blocks the connection port when moving toward the connection port.

5. The capillary puncture microneedle for intratympanic drug delivery according to claim 4, characterized in that: The end of the guide core is a plug (311), and the surface of the plug (311) facing the connection port is a curved surface.

6. The capillary puncture microneedle for intratympanic drug delivery according to any one of claims 1 to 5, 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.

7. The capillary puncture microneedle for intratympanic drug delivery according to claim 6, characterized in that: The limiting portion (21) is a blocking piece sleeved at the connection between the capillary microneedle and the trocar.

8. The capillary puncture microneedle for intratympanic drug delivery according to claim 7, characterized in that: The trocar is provided with a stopper (22) which is in close contact with the stopper.

9. The capillary puncture microneedle for intratympanic drug delivery according to claim 1, characterized in that: A catheter seat (4) is provided at the proximal end of the infusion part (12), and the catheter seat (4) comprises a first cavity (41) coaxially connected to the infusion part (12), and a second cavity (42) connected to the side wall of the first cavity (41), and the guide core extends from the first cavity (41) into the inner cavity of the infusion part (12); a handle (5) is provided on the catheter seat (4).

10. The capillary puncture microneedle for intratympanic drug delivery according to claim 9, characterized in that: There is a gap between the outer wall of the guide core and the inner walls of the first cavity (41) and the infusion part (12).