CN220385614U - Inner ear micro-drug administration device - Google Patents
Inner ear micro-drug administration device Download PDFInfo
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- CN220385614U CN220385614U CN202321758105.4U CN202321758105U CN220385614U CN 220385614 U CN220385614 U CN 220385614U CN 202321758105 U CN202321758105 U CN 202321758105U CN 220385614 U CN220385614 U CN 220385614U
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- 238000012377 drug delivery Methods 0.000 claims abstract description 17
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Landscapes
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
The utility model discloses an inner ear micro drug delivery device, which comprises a needle seat, a needle tube arranged on the needle seat, a sealing cap for sealing the needle seat and a needle head connected to the needle tube, wherein the needle seat is provided with a top end and a tail end, the tail end of the needle seat is provided with the sealing cap, the needle tube is a soft tube body, one end of the needle tube is connected to the top end of the needle seat, the other end of the needle tube is connected with the needle head, the needle head comprises a needle tip and a needle tail, the needle tail is coaxially connected to the needle tube, and the needle tip comprises a straight line section connected to the needle tail and a bending section integrated with the straight line section. The utility model can realize various flexible displacements in axial rotation, plane and depth direction, and is beneficial to the adjustment of the angle and the position of the bending section of the needle head.
Description
Technical Field
The utility model relates to the technical field of medical auxiliary tools, in particular to an inner ear micro-drug delivery device.
Background
According to World Health Organization (WHO) statistics, to date, about 15 million people worldwide suffer from a degree of hearing loss exceeding 5% of the world's general population, i.e., at least 4.66 million people suffer from moderate and above disabled hearing losses, including 4.32 million adults and 3400 million children. According to the four-province survey data of the rehabilitation research center for the deaf children in 2016, the occurrence rate of the hearing impairment in China is 15.8 percent, about 2 hundred million people are combined, and the occurrence rate of the hearing impairment (caused by disability) above the middle degree is 5.17 percent, about 7000 ten thousand people. Of the congenital deafness, about 60% are due to genetic factors, and it has been found that more than 150 genes including OTOF, GJB2, STRC, TMC1, SLC22A4, ACTG1, CCDC50 and the like are associated with deafness. The above-described gene mutations disrupt the survival and morphological integrity of cochlear hair cells, supporting cells, and vestibular organ cells, resulting in deafness or vestibular dysfunction. There is no effective therapeutic drug for genetic deafness caused by gene mutation in clinic.
In recent years, with the development of AAV-based delivery vector gene therapy and hair cell regeneration strategy-based stem cell therapy, a plurality of clinical trials of deafness gene therapy and stem cell therapy are underway worldwide, and a novel approach is provided for radical treatment of hearing loss and vestibular dysfunction. As a new generation of hereditary hearing loss treatment method, compared with the traditional hearing aid or artificial cochlea, the gene therapy and stem cell therapy of the hearing loss can enable severely-to-severely-hearing impaired people (especially hearing impaired people suffering from the hearing loss caused by mutation of specific genes) to regain the perception capability of natural sound, and have extremely important application value and wide development prospect. However, due to the presence of the blood-cochlear barrier in the inner ear, most drugs can only achieve limited treatment by systemic administration (oral or intravenous), so delivering drugs directly into the inner ear to achieve accurate and effective treatment has become a necessary treatment means, i.e., to increase the drug concentration in the inner ear by a specific route of administration, thereby exerting drug efficacy.
Anatomically, human ear structures can be divided from the outside to the inside into the outer ear, middle ear, inner ear: the auricle comprises auricles and an external auditory canal; the tympanic cavity anatomically belongs to a part of the middle ear, the outer limit of the tympanic cavity is the tympanic membrane, and the tympanic membrane separates the tympanic cavity from the external auditory canal; the inner wall of the tympanic cavity, i.e., the lateral bone wall of the cochlea, is one of the components of the inner ear. The traditional open operation route and various devices and devices used clinically in the past cannot be qualified for inner ear administration. Firstly, the length of the needle body of a common metal pipetting needle (such as the metal pipetting needle used in various fundus surgeries) which is matched with various hollow needles (pipettes) used in clinical work is too short, and the administration target position of the inner ear can not be guaranteed to be reached through the tympanic membrane after the needle body passes through the external auditory meatus. And secondly, even if the needle body is long enough to cross the external auditory canal to reach the inner ear, the external diameter of the needle body is too thick, the needle body is of a rigid structure and cannot be bent, and the needle body and the endoscopic body of the otoscope can be mutually blocked, so that the operation of the external auditory canal path under the endoscopic with the natural passage of the otoscope, which is less in wound, is not facilitated to be completed by matching with the otoscope. And the rear parts of the various pipetting needles are connected with hollow needles with different volumes, and the outer diameters of the hollow needles are thick, so that the external auditory meatus can be blocked to directly block the otoscope body from entering the external auditory meatus. In addition, most pipetting needle tips have too thick outer diameters and do not have reasonable bending angles, and potential damage to important structures of the inner ear is possible. More importantly, the volume of the inner ear membrane labyrinth is small, contains very fine anatomical microstructures (cochlear volume of only about 190 microliters), and the total and rate of drug delivery to the inner ear needs to be precisely controlled on the microliter scale. The various pipetting needles cannot be matched with the microsyringe and the micro-operation pump, and cannot be combined with the microsyringe and the micro-operation pump to form a complete inner ear administration system or platform to finish the aim of accurate administration. In general, the anatomy structure of the inner ear is complex, cochlear tissue is used as a core structure of a sound sensing link, the cochlea tissue is positioned deep in the intracranial temporal bone in an anatomical position, the structure is exquisite, complex and closed, and minimally invasive operation and microinjection are more needed on the premise that the medicine directly enters the cochlea. However, current technical means and devices are not able to accomplish the goal of direct injection of drugs into the inner ear, which is a great challenge for gene therapy or stem cell therapy.
At present, indirect administration to the inner ear is realized by adopting a mode of injecting medicines into the local anesthesia lower drum in clinical work. Drugs entering the tympanic cavity can enter the inner ear by permeation through the round window membrane to achieve certain therapeutic objectives (e.g., improving dizziness, improving impaired hearing, etc.). The general process of intrathecal injection is for the physician to perform tympanostomy using the needle portion of a specially made metal pipette needle pre-attached to a syringe, and then push the drug into the tympanic cavity while maintaining the needle penetrating the tympanic cavity and stabilizing its position. The medicine remained in the tympanic cavity passes through the round window membrane with smaller area on the inner wall of the tympanic cavity through the slow permeation process and finally enters the perilymph of the tympanic cavity, thereby playing the medicine effect and achieving the purpose of treatment. But this approach has certain disadvantages. First, the drug is limited in its effectiveness through the round window membrane and is very prone to loss through the eustachian tube, thus being far less effective than injecting the drug directly into the inner ear. Second, the indirect means of delivering the drug by intrathecal injection is not able to determine the amount administered because of absorption efficiency issues. This is not applicable to gene therapy and stem cell therapy for deafness which address the "trace" principle. Again, the metal pipetting needles used for intrathecal injection are long and inflexible. In the external auditory canal path operation under the otoscope, the metal pipetting needle is mutually interfered with the otoscope lens close to the tympanic cavity, and meanwhile, the advancing and retreating operation of the otoscope is blocked, so that the internal ear injection operation can not be successfully completed. In addition, if the round window membrane is used as a drug delivery target, the round window niche, the round window membrane and the scala tympani are mutually angled from the anatomical structure, the ideal pipette tip needs a certain angle of bending to facilitate the needle tip to smoothly enter the scala tympani through the round window, and the straight and unbent pipette tip for intra-tympanic injection does not meet the anatomical requirement. In addition, the outer diameter of the needle tip of the intrathecal injection metal pipetting needle is too thick, the damage to the round window membrane is large, and the backflow and extravasation of medicines or perilymph are easy to cause, which is still not preferable for deafness gene therapy and stem cell therapy which are in accordance with the "minimally invasive" principle.
In summary, the existing devices represented by various pipetting needles have obvious defects in aspects of needle body materials, lengths, outer diameter thicknesses, needle tip shapes, smaller operation wounds realized by matching with otoscope operations and accurate administration, so that the inner ear injection operation cannot be finished, and accurate, minimally invasive and micro-delivery of therapeutic drugs to the inner ear cannot be realized. Thus, there is a need for an inner ear microdose device.
Disclosure of Invention
The utility model aims to solve the defects of the technology and designs an inner ear micro-drug delivery device.
The utility model relates to an inner ear micro drug delivery device, which comprises a needle seat, a needle tube arranged on the needle seat, a sealing cap for sealing the needle seat and a needle head connected with the needle tube. The needle seat is provided with a top end and a tail end, the tail end of the needle seat is provided with a sealing cap, the needle tube is a soft tube body, one end of the needle tube is connected to the top end of the needle seat, the other end of the needle tube is connected with a needle head, the needle head comprises a needle point and a needle tail, the needle tail is coaxially connected to the needle tube, and the needle point comprises a straight line section connected to the needle tail and a bending section integrated with the straight line section. The utility model can realize various flexible displacements in axial rotation, plane and depth direction, and is beneficial to the adjustment of the angle and the position of the bending section of the needle head.
Further preferably, the needle tube is made of polyurethane.
Preferably, the total length of the needle tube is between 100 and 120 mm.
Further preferably, the sealing cap is used for being penetrated by an external syringe needle, and the tip of the syringe needle stays in the needle seat after the syringe needle is penetrated by the sealing cap.
Further preferably, the needle head is made of stainless steel.
Further preferably, the needle tail is inserted in the needle tube and forms tight fit.
Further preferably, the bent section and the straight section are configured to pierce the inner ear of the patient.
Preferably, the angle between the bending section and the straight line section is 25-35 degrees.
Preferably, the length of the bending section is between 1.5 and 2.0 mm.
Further optimizing, by the operator manipulating the microscopy instrument grip and imparting various flexible movements to the needle portion including axial rotation, planar and depth direction.
In general, a rigid metal pipette needle has a rigid structure, so that it is very difficult to adjust the inclination angle and the direction of the needle tip at will in the external auditory canal when the needle is used for tympanostomy. If the round window membrane is used as a drug delivery target, even if the needle tip of the rigid pipetting needle punctures the round window membrane, the needle tip part cannot conform to the natural trend of the scala tympani because of no bending treatment, and the basal membrane of the cochlea bottom ring is easily damaged. The utility model can avoid the problems, under the direct view of the otoscope, the angle and the position of the liquid-transferring needle can be flexibly adjusted by utilizing the characteristic that the needle tube is soft and can be bent at will, the liquid-transferring needle conforms to the natural trend of the external auditory canal, the synchronous axial rotation of the needle point is realized by utilizing the axial rotation of the liquid-transferring needle and the sealing cap, and the needle point conforms to the natural anatomical trend of the scala tympani and is favorable for breaking through a round window membrane and being placed into the scala tympani. In the process of position and angle adjustment, the needle seat with small volume and the rear-end equipment connected with the needle seat can be fixed around auricles, can not excessively occupy the limited space of the external auditory meatus, and can not cause any interference and influence on flexible operation of the otoscope.
In summary, the utility model has the following technical effects:
1. the axial flexible rotation of the pipetting needle can be realized, and the angle adjustment of the bending section of the needle head is facilitated;
2. the utility model is used together with the micro-upgrade micro-injector and the external micro-pump as a whole, can realize accurate drug delivery to the inner ear, can conform to the natural trend of the scala tympani after the bending section enters the round window membrane, and can not stab the basal membrane to cause damage; the needle seat sealing cap pierces the syringe needle to realize 'two-stage' connection with the micro-liter-level microsyringe, the whole tightness is good, and no liquid leakage is caused;
3. if the administration volume is large, multiple injections are needed, the two-section design is convenient for the operator to fill the medicine again only by pulling out the self-sealing cap of the syringe needle connected with the microsyringe, and the needle stand, the needle tube and the needle tip do not need to be taken out from the auditory canal as a whole and then filled. The two-stage design requires that the tip of the syringe needle is in a state of penetrating the sealing cap and being placed in the needle seat, and a 'storage cabin' for temporarily storing the therapeutic drug can be formed in the needle seat at the moment, and a small amount of bubbles generated by refilling the drug can stay in the 'storage cabin'. Namely, the storage bin can avoid that air bubbles filled with medicines are directly input into the pipetting needle to influence the administration accuracy due to the fact that the microsyringe is directly connected with the needle seat (integrated connection), and also avoid gas embolism in the scala tympani;
4. because the inner diameter of the needle tip is small, the needle tube at the rear is required to provide enough positive pressure to ensure smooth liquid discharge. The soft needle tube has a non-rigid structure and high compliance, and is soft in texture and contains local bulge, so that a decompression chamber for buffering the medicine liquid pressure is formed in the needle seat, and the soft needle tube part is prevented from being subjected to overlarge liquid pressure and local expansion in the medicine feeding process. In other words, if a soft needle tube is locally "bulged", this indicates that a blockage has occurred in the tip of the thin needle tube.
Drawings
FIG. 1 is a general block diagram of the present utility model;
FIG. 2 is a general construction view of the present utility model after the syringe needle is attached;
fig. 3 is an enlarged view at a in fig. 2.
In the figure: 1. a needle stand; 2. a needle tube; 3. a syringe needle; 4. sealing caps; 5. a needle; 51. a needle tip; 511. a straight line segment; 512. a bending section; 52. the needle tail.
Detailed Description
The following description of the embodiments of the present utility model will be made clearly and fully with reference to the accompanying drawings, in which some, but not all embodiments of the utility model are shown. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the utility model, fall within the scope of protection of the utility model.
In this embodiment, as shown in fig. 1 to 3, the needle tube comprises a needle seat 1 and a needle tube 2 arranged on the needle seat 1, the needle seat 1 is provided with a top end and a tail end, the tail end of the needle seat 1 is provided with a sealing cap 4, one end of the sealing cap 4 is a closed blind end for receiving the penetration of a syringe needle 3, and the other end is an opening, and the sealing cap can be screwed and sealed with the needle seat 1 by means of an internal thread structure thereof.
The needle tube 2 is a soft tube body, has soft and bendable texture, one end of the needle tube 2 is connected to the top end of the needle seat 1, the other end of the needle tube 2 is connected with the needle head 5, the needle tube 2 is made of Polyurethane (PU), the total length of the needle tube 2 is 100-120 mm, preferably 110mm, and the inner diameter and the outer diameter of the needle tube 2 are 0.53 mm and 0.9mm respectively. The needle tube 2 is usually transparent, so that the administration condition can be observed visually, such as whether air bubbles exist.
The needle 5 comprises a needle point 51 and a needle tail 52, which are made of stainless steel, the needle tail 52 is coaxially connected with the needle tube 2, the needle tail 52 is inserted into the needle tube 2, and the stainless steel needle tail 52 can be inserted into the end part of the needle tube 2 to form tight fit due to the soft material of the needle tube 2.
The needle tip 51 includes a straight section 511 connected to the needle tail 52 and a bent section 512 integral with the straight section 511.
The bending section 512 and the straight line section 511 are configured to pierce the round window membrane of the inner ear of the patient, that is, the joint between the bending section 512 and the straight line section 511 may be rounded or the bending section 512 may be a smooth arc section or a straight line tube shape, in addition, the top end of the bending section 512 may be beveled as a piercing end, so as to facilitate piercing without causing large-area breach.
The total length of the needle 5 is generally 8.8mm, and the length of the bending section 512 is 1.5-2.0 mm, preferably 1.8mm; the angle between the bent section 512 and the straight section 511 is between 25 and 35 degrees, preferably 30 degrees.
When the tip of the syringe needle 3 is pierced from the sealing cap 4, the tip thereof stays in the needle holder 1, and sealing is achieved between the syringe needle 3 and the sealing cap 4. In addition, the axial rotation can be realized between the syringe needle 3 and the sealing cap 4, and the axial rotation of the sealing cap 4 can synchronously drive the needle seat 1, the needle tube 2 and the needle 5 at the far end to axially rotate as a whole. The operator can use the ear surgical micro-instrument to hold the needle tube 2, then operate the micro-instrument to enable the needle tube 2 to realize axial rotation and flexible displacement in the plane and depth directions, so as to drive the needle tip 51 to synchronously rotate and displace to form an optimal administration position, finally the seat end of the syringe needle 3 is connected with an external micro pump, the medicine is injected into the needle seat 1 through the syringe needle 3, and then the medicine flows to the needle tip 51 through the needle tube 2.
The movement of the needle 5 includes axial rotation, i.e., rotation along the axial direction of the needle tube 2; plane direction movement, i.e. translation of the needle 5 in the horizontal plane; the movement in the depth direction, i.e. the upward and downward movement of the needle 5 along the axial direction of the needle tube 2, realizes the flexible movement of the needle 5.
The present utility model is not limited to the above-described preferred embodiments, and any person who can obtain other various products under the teaching of the present utility model, however, any change in shape or structure of the product is within the scope of the present utility model, and all the products having the same or similar technical solutions as the present application are included.
Claims (10)
1. The utility model provides an inner ear micro drug delivery device, its characterized in that, it include needle file (1), set up in needle tubing (2) on needle file (1), seal cap (4) of sealed needle file (1) and connect syringe needle (5) on needle tubing (2), needle file (1) have top and tail end, the tail end of needle file (1) is equipped with seals cap (4), needle tubing (2) are soft body, needle tubing (2) one end is connected in needle file (1) top, and the other end is connected with syringe needle (5), syringe needle (5) include needle point (51) and needle tail (52), needle tail (52) coaxial to be connected in needle tubing (2), needle point (51) are including connecting in straightway (511) of needle tail (52) and with straightway (511) integrative bending section (512).
2. The inner ear micro-drug delivery device according to claim 1, wherein the needle tube (2) is made of polyurethane, and the needle tube (2) is soft and bendable.
3. The inner ear microdose device according to claim 2, characterized in that the total length of the needle tube (2) is between 100 and 120 mm.
4. The inner ear micro-drug delivery device according to claim 1, wherein the sealing cap (4) is pierced by an external syringe needle (3), and the tip of the syringe needle (3) stays in the needle holder (1) after the sealing cap (4) is pierced.
5. The inner ear micro-drug delivery device according to claim 1, wherein the needle (5) is made of stainless steel.
6. The inner ear micro-drug delivery device according to claim 1, wherein the tail (52) is inserted into the needle tube (2) and forms a tight fit.
7. The inner ear micro-drug delivery device of claim 1, wherein the bent section (512) and straight section (511) are configured to pierce the inner ear of a patient.
8. The inner ear micro-drug delivery device of claim 7, wherein the angle between the bent section (512) and the straight section (511) is 25-35 degrees.
9. The inner ear micro-drug delivery device of claim 8, wherein the bending section (512) is between 1.5 and 2.0mm in length.
10. The inner ear micro-drug delivery device according to claim 1, wherein the needle tube (2) is held by a micro-machine and the needle (5) is partially moved in the directions including axial rotation, plane and depth by manipulating the micro-machine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202321758105.4U CN220385614U (en) | 2023-07-05 | 2023-07-05 | Inner ear micro-drug administration device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202321758105.4U CN220385614U (en) | 2023-07-05 | 2023-07-05 | Inner ear micro-drug administration device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN220385614U true CN220385614U (en) | 2024-01-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202321758105.4U Active CN220385614U (en) | 2023-07-05 | 2023-07-05 | Inner ear micro-drug administration device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN220385614U (en) |
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2023
- 2023-07-05 CN CN202321758105.4U patent/CN220385614U/en active Active
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