CN115517854A

CN115517854A - Tympanic cavity drug administration device

Info

Publication number: CN115517854A
Application number: CN202211175610.6A
Authority: CN
Inventors: 孟璐; 张立争; 戴雯婕; 李锐; 张劼
Original assignee: Shanghai Microport Medical Technology Co ltd
Current assignee: Shanghai Microport Medical Technology Co ltd
Priority date: 2022-09-26
Filing date: 2022-09-26
Publication date: 2022-12-27

Abstract

The invention discloses a tympanic administration device, comprising: the main body part is connected with the fixing part and is provided with two cavities which are respectively a medicine inlet channel and an exhaust channel; the drug administration slow release part is arranged at the far end of the main body part, a drug cavity and micropores distributed on the wall of the drug cavity are formed in the drug administration slow release part, and the drug inlet channel and the air exhaust channel are communicated with the drug cavity and communicated with the outside through the micropores. The tympanic cavity administration device provided by the invention is convenient for multiple administrations, and reduces the times of tympanum puncture; the patient only needs to operate once in the hospital, the medical resource pressure is relieved, and the dosage can be controlled.

Description

Tympanic cavity drug administration device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a tympanic cavity drug delivery device.

Background

Intratympanic steroid hormone injection therapy for inner ear diseases, such as sudden sensorineural deafness, intractable secretory otitis media, meniere's disease, and autoimmune inner ear diseases, has proven effective in the past few decades and has been written in the diagnostic guidelines in china, the united states, and the like. Intratympanic injection of steroid hormones with higher concentrations of epilymphatic and endolymphatic steroids than systemic steroids can bypass the blood-labyrinth barrier into the inner ear and can achieve higher concentrations in the membranous labyrinth. This is based on the fact that drugs have a penetrating power through the round window membrane, which is a semi-permeable membrane that is permeable to ions, molecules and some drugs. Different substances cross membranes in different pathways and are affected by different factors. Glucocorticoid receptors, mineralocorticoid receptors, natriuretic peptide receptors, and aquaporins are present in the inner ear.

Although the tympanogram injection of steroid hormone has the advantages of improving the drug concentration of inner ear, reducing the side effect of the whole body and the like, and can be used as the supplementary therapy of the failure of the whole body therapy, and has definite clinical indications and wide clinical requirements. And there is evidence that the therapeutic effect of the alternate-day injection is more positive. However, each administration needs tympanocentesis, and needs to be performed by skilled otolaryngological professional medical care personnel, and many hospitals cannot provide tympanocentesis treatment, which is not as convenient as intravenous injection or oral administration. Sometimes, the patients cannot be injected in time according to the disease condition because of the time arrangement and traffic problems of the patients, or the weekend and holiday arrangement of the hospital, or too many patients, and the treatment effect and disease recovery are affected. And multiple tympanocentesis has local side effects such as bleeding, pain, dizziness, unhealed perforation of the tympanocentesis and the like.

Therefore, a medical instrument with low price and convenient operation is urgently needed in clinic at present, the requirement of repeated tympanum administration of diseases can be met, the injury caused by repeated tympanum puncture is reduced, the patient can conveniently take the medicine at home, the times of going to and returning to a hospital are reduced, and the pressure of medical resources is relieved.

Disclosure of Invention

The invention aims to provide a tympanic cavity administration device, which is convenient for multiple administrations and reduces the times of tympanum puncture; the patient only needs to operate once in the hospital, the medical resource pressure is relieved, and the dosage can be controlled.

In order to achieve the purpose, the technical scheme adopted by the invention is to provide a tympanic cavity drug delivery device, which comprises a main body part, a fixing part and a drug delivery slow-release part, wherein the main body part is connected with the fixing part and is provided with two cavities which are a drug inlet channel and an air exhaust channel respectively; the drug administration slow release part is arranged at the far end of the main body part, a drug cavity and micropores distributed on the wall of the drug cavity are formed in the drug administration slow release part, and the drug inlet channel and the air exhaust channel are communicated with the drug cavity and communicated with the outside through the micropores.

Preferably, the proximal end of the main body part comprises two single-cavity tubes arranged in parallel, and the distal end of the main body part extends from the medicine inlet channel and the air exhaust channel to form a double-cavity tube.

Preferably, the main body part comprises a connecting piece which is communicated with the two single-cavity tubes and the two double-cavity tubes.

Preferably, the connecting piece is a three-way connecting piece, and the connecting piece is used for communicating the single cavity tube with the double cavity tube through welding; or the connecting piece is made of the same material as the double-cavity tube and the single-cavity tube, and the single-cavity tube is communicated with the double-cavity tube through adhesion.

Preferably, the surface of the main body piece or/and the drug delivery slow-release part is provided with a hydrophilic coating or an antibacterial coating.

Preferably, the main body part and the administration sustained-release part are made of latex, PU, TPU, silica gel, polylactic acid or glycolide-lactide copolymer.

Preferably, a first connector is included, the first connector being disposed at the proximal end of the access channel.

Preferably, a sealing member is included, the sealing member being coupled to the proximal end of the intake passage and/or the proximal end of the exhaust passage.

Preferably, the fixing member has a through hole through which the main body member passes, and the hole diameter of the through hole is gradually smaller from the distal end side to the proximal end side.

Preferably, the fixing piece is divided into a first section, a second section and a third section from the near end to the far end, the first section comprises a columnar part and an arc-shaped arm, the second section is columnar, the diameter of the second section is smaller than that of the columnar part of the first section, the third section is a flexible fixing cap, and an arc surface with the diameter gradually increased is formed from the far end to the near end.

Preferably, the drug delivery slow-release part comprises a connecting end and a slow-release end, the connecting end is connected with the far end of the main body part, the slow-release end is of a spherical structure, and the drug cavity is formed in the slow-release end.

Compared with the prior art, the invention has the following beneficial effects: according to the tympanic cavity drug delivery device provided by the invention, the purposes of injection and intra-aural pressure balance can be realized only by pricking one hole on the tympanic membrane through arranging the main body part comprising the drug inlet channel and the air exhaust channel; the fixing piece is arranged, so that the main body piece is fixed, and the main body piece is prevented from moving; the main body part can be placed in the middle ear cavity in a treatment period to achieve the purpose of out-of-hospital drug delivery, and a patient only needs to operate once in a hospital, so that the number of times that the patient comes and goes to the hospital is reduced, the problem that the patient frequently comes and goes to the hospital is solved, and the pressure of medical resources is relieved; during the administration period, the tympanic membrane only needs to be perforated once, thus facilitating multiple administrations, reducing the times of tympanic membrane puncture injury, and avoiding local side effects of bleeding, pain, dizziness, unhealed tympanic membrane puncture and the like caused by multiple tympanum punctures; furthermore, the administration amount of the sustained-release part can be controlled.

Drawings

FIG. 1 is a schematic view of a tympanometric drug delivery device and its use in accordance with an embodiment of the invention;

FIG. 2 is a schematic view of a fixing member according to an embodiment of the present invention;

fig. 3 is a schematic structural diagram of a drug delivery sustained-release portion in an embodiment of the present invention.

In the figure:

1-tympanic cavity administration device, 2-external ear, 3-external ear canal, 4-tympanic membrane, 5-middle ear cavity, 10-main body part, 11-first joint, 111-second joint, 12-single lumen tube, 13-connecting part, 14-fixing part, 15-double lumen tube, 16-administration slow release part, 17-sealing plug, 121-medicine inlet channel, 122-air outlet channel, 141-first section, 141 a-column part, 141 b-arc arm, 142-through hole, 143-third section, 144-second section, 161-connecting end, 162-slow release end, 163-micropore and 164-medicine cavity.

Detailed Description

The invention is further described below with reference to the figures and examples.

It should be noted that the terms "inner", "outer", "upper", "lower", and the like as used herein are for illustrative purposes only and do not mean a unique embodiment. The term "distal" refers to the end that extends into the ear or away from the operator, "proximal" refers to the end that is outside the body or near the operator, and the term "axial" is the direction in which the central axis of the dual lumen tube is located.

Referring to fig. 1, the present embodiment provides a tympanogram drug delivery device 1, which includes: the main body part 10 is connected with the fixing part 14, the main body part 10 is provided with two cavities, namely a medicine inlet channel 121 and an air exhaust channel 122; the fixing part 14 can be fixed at the external ear 2 of a human body, so that the whole tympanic cavity drug delivery device 1 is fixed in the ear of the human body to realize the tympanic cavity drug delivery; the administration slow-release part 16 is arranged at the far end of the main body part 10, the administration slow-release part 16 is provided with a medicine cavity 164 for storing medicine and micropores 163 distributed on the wall of the medicine cavity 164, the medicine inlet channel 121 and the air outlet channel 122 are both communicated with the medicine cavity 164 and communicated with the outside through the micropores 163, so that the medicine inlet channel 121 and the air outlet channel 122 form a loop, and when the medicine inlet channel 121 injects the medicine, the air outlet channel 122 can balance the intra-aural pressure. Therefore, the tympanometry device provided by the embodiment can reduce the volume of the air exhaust channel 122 and the medicine inlet channel 121 in the ear cavity, facilitate air circulation and facilitate fixing at the external ear of a human body.

With continued reference to fig. 1, in one embodiment, the main body member 10 includes two single-lumen tubes 12 and two-lumen tubes 15, and the two single-lumen tubes 12 and the two lumens 15 are in one-to-one correspondence, so as to form an intake channel 121 and an exhaust channel 122. Further, the main body member 10 includes a connecting member 13, and the connecting member 13 connects the two single-lumen tubes 12 and the two-lumen tube 15. When the device is used, the two single-cavity tubes 12 are arranged outside a human body and can be pasted behind ears by medical adhesive tapes, the double-cavity tube 15 is connected with the fixing piece 14, the fixing piece 14 is fixed at the position of the external ear 2, the double-cavity tube 15 is fixed in the ear of the human body through the fixing piece 14, the double-cavity tube 15 continuously penetrates through the external ear canal 3 and the tympanic membrane 4 to enter the middle ear cavity 5, and the drug delivery slow-release part 16 releases drugs in the middle ear cavity 5 to realize directional drug delivery. Furthermore, functional coatings such as hydrophilic or antibacterial coatings can be added on the outer surfaces of the double-cavity tube 15 and the drug delivery slow-release part 16 by spraying, dipping and other methods, so that the customization of specific functions is realized.

Specifically, the connecting member 13 is a three-way connecting member, and the length thereof may be between 1mm and 15mm, in an embodiment, the material of the connecting member 13 may be a heat-shrinkable material, and the selected material may be polyethylene, vinyl acetate copolymer, polyvinyl chloride, polytetrafluoroethylene, polyvinylidene chloride, etc., preferably polyethylene, and the two single-lumen tubes 12 and the two double-lumen tubes 15 are connected by welding; in another preferred embodiment, the connecting piece 13 is made of the same material as the single-cavity tube 12 and the double-cavity tube 15, and the two single-cavity tubes 12 and the double-cavity tube 15 are connected by using an adhesion method. In other embodiments, the connector 13 may be omitted, such as two single-lumen tubes directly, the single-lumen tube outside the body is bifurcated, the two single-lumen tubes inside the ear are adhered together and jointly penetrate through the through hole 142 of the fixing member 14, the external auditory canal 3 and the tympanic membrane 4 to enter the middle ear cavity 5, or an integrally formed Y-shaped tube is directly used. The present invention is not limited in particular to the specific configuration of the drug inlet channel 121 and the air outlet channel 122, as long as the drug inlet channel 121 and the air outlet channel 122 are provided to achieve circuit ventilation and release the drug to the middle ear cavity 5.

Preferably, the axial length of the single lumen tube 12 is preferably 5mm to 350mm, and the outer diameter is preferably 0.05mm to 3mm, more preferably 0.3mm; the internal diameter is preferably 0.03mm to 2.8mm, more preferably 0.15mm. The double lumen tube 15 preferably has an axial length of 50mm to 450mm, an outer diameter of preferably 0.3mm to 3mm, more preferably 0.5mm, and an inner diameter of each single lumen of preferably 0.05mm to 0.7mm, more preferably 0.15mm. The hardness of the single-cavity tube 12 and the double-cavity tube 15 is preferably the Shore hardness between 35A and 90D according to requirements.

The materials of the single-cavity tube 12, the double-cavity tube 15 and the drug-delivery slow-release head 16 can be natural or synthetic high polymer such as latex, PU, TPU, silica gel and the like, and can also be novel degradable high polymer such as polylactic acid, glycolide-lactide copolymer and the like, and the molecular weight can be from ten thousand to hundreds of thousands. The overall color is the color of the material itself.

With continued reference to fig. 1, in one embodiment, a first connector 11 is included, the first connector 11 being disposed at a proximal end of the access channel 121 for connection to a drug delivery device; the first connector 11 is typically a universal connector, such as a luer connector or the like, for connecting the access channel 121 to an administration device, such as a syringe or the like. Further, a sealing plug 17 is provided, and the sealing plug 17 is a sealing part of the first joint 11 and is coupled with the first joint 11, and the connection form is not limited to a threaded connection, a morse taper connection and the like. When the medicine feeding device is not used, the first connector 11 is sealed by the sealing plug 17, so that a pollution source is prevented from entering the medicine feeding channel 121, and when the medicine feeding device is used, the sealing plug 17 is opened, and the medicine feeding device is connected to the first connector 11, so that medicine injection can be carried out.

As for the vent passage 122, a second joint 111 and a sealing plug 17 may be provided at the proximal end as for the medication intake passage 121, and the sealing plug 17 may be used to seal the second joint 111 when not in use, to prevent a source of contamination from entering the vent passage 122, and to open the sealing plug 17 to communicate with the medication intake passage 121 when in use, to balance the in-ear pressure. In other embodiments, the proximal end of the vent passage 122 may be provided without the second fitting 111 and the sealing plug 17, with the vent passage 122 port remaining open, or the proximal end of the vent passage 122 may be provided directly with a sealing plug or sealing cover.

Referring to fig. 1 and 2, the fixing member 14 has a through hole 142 extending axially therethrough, and the main body 10 is fixed through the through hole 142, preferably, the diameter of the through hole 142 is gradually decreased from the distal end to the proximal end, so that the dual lumen tube 15 is easier to move from the proximal end to the distal end relative to the fixing member 14, and is harder to move from the distal end to the proximal end relative to the fixing member 14, which not only facilitates the installation of the dual lumen tube 15, but also prevents the dual lumen tube 15 from moving during the use, and forms a clearance fit, an interference fit between the through hole 142 at the distal end and the dual lumen tube 15, or fixes the dual lumen tube 15 in the fixing member 14 by gluing or the like. In a specific embodiment, the fixing member 14 is divided into a first section 141, a second section 144 and a third section 143 from the proximal end to the distal end, the first section 141 includes a column portion 141a and an arc-shaped arm 141b, the second section 144 is a column, the diameter of the second section 144 is smaller than that of the column portion 141a of the first section 141, the third section 143 is a flexible fixing cap made of a flexible polymer material, the third section 143 forms an arc surface with gradually increasing diameter from the distal end to the proximal end, and at least one of the diameters is slightly larger than that of the external auditory canal 3, so that the third section 143 can be lightly attached to the inner wall of the entrance of the external auditory canal 3. The shape of the first section 141 fits the human concha 2 physiology, and includes a column portion 141a and an arc-shaped arm 141b extending along the column portion 141a to form a 6-shape, and the first section 141 can be clipped at the cymba concha position, so that the fixing member 14 can be fixed at the concha 2. Preferably, the first section 141, the second section 144 and the third section 143 are integrally formed.

Referring to fig. 1 and 3, the administration sustained-release part 16 includes a connection end 161 and a sustained-release end 162, the connection end 161 is connected to the distal end of the double-lumen tube 15, and may be implemented by gluing; the slow release end 162 is of a spherical structure, a drug cavity 164 for temporarily storing drugs is formed in the slow release end 162, a plurality of micropores 163 are distributed on the spherical wall of the slow release end 162, and the drugs are slowly released into the middle ear cavity 5 through the micropores 163.

The sealing plug 17 and the fixing member 14 can be made of natural or synthetic high molecular polymers such as latex, PU, TPU, silica gel and the like, or can be made of novel degradable high molecular polymers such as polylactic acid, glycolide-lactide copolymer and the like, and the molecular weight can be from ten thousand to hundreds of thousands.

With continued reference to fig. 1, when the tympanogram drug delivery device 1 of the present invention is used, a medical professional penetrates the drug delivery slow-release section 16 through the tympanic membrane 4 which has been perforated in advance, so that the drug delivery slow-release section 16 is located in the middle ear cavity 5, thereby achieving the directional drug delivery function. The third section 143 of the securing member 14 is positioned at the outer edge of the concha cavity and the first section 141 is positioned at the cymba concha site to secure the double lumen tube 15. Two single-cavity tubes 12 arranged outside the body are pasted on the back of the ear by medical adhesive tapes, after the single-cavity tubes 12 are fixed, one single-cavity tube 12 is used as a medicine feeding channel 121, a sealing plug 17 is opened, and medicine feeding equipment is connected to a first joint 11 to carry out medicine injection; at the same time, the other lumen tube 12 also needs to open the sealing plug 17, which will serve as a venting channel 122 for equalizing the in-ear pressure. After the medicine is injected, the sealing plugs 17 of the two single-cavity tubes 12 are respectively sealed, so that a pollution source is prevented from entering the administration tube cavity, the single administration operation is finished, the tympanic administration device 1 is continuously kept in the ear of a patient, and the subsequent administration is needed only by opening the sealing plugs 17 of the two single-cavity tubes 12 to be connected with administration equipment, so that the operation is repeated.

In conclusion, the tympanic cavity administration device provided by the invention can realize the purposes of injection and intra-aural pressure balance only by pricking one hole on the tympanic membrane through arranging the main body part comprising the medicine inlet channel and the air exhaust channel; the fixing piece is arranged, so that the main body piece is fixed, and the main body piece is prevented from moving; the main body piece can be placed in the middle ear cavity in a treatment period to achieve the purpose of out-of-hospital administration, and a patient only needs to operate once in a hospital, so that the times of the patient to and fro the hospital are reduced, the problem that the patient frequently comes and goes to the hospital is solved, and the pressure of medical resources is relieved; during the administration period, the tympanic membrane only needs to be perforated once, thus facilitating multiple administrations, reducing the times of tympanic membrane puncture injury, and avoiding local side effects of bleeding, pain, dizziness, unhealed tympanic membrane puncture and the like caused by multiple tympanum punctures; and the administration slow-release part can control the administration amount.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A tympanogram drug delivery device, comprising: the main body part is connected with the fixing part and is provided with two cavities which are respectively a medicine inlet channel and an exhaust channel; the drug administration slow release part is arranged at the far end of the main body part, a drug cavity and micropores distributed on the wall of the drug cavity are formed in the drug administration slow release part, and the drug inlet channel and the air exhaust channel are communicated with the drug cavity and communicated with the outside through the micropores.

2. The tympanometry drug delivery device of claim 1, wherein the main body piece comprises two single lumen tubes and a dual lumen tube, the two single lumen tubes communicating with two channels in the dual lumen tube in a one-to-one correspondence to form the intake and exhaust channels.

3. The tympanometric drug delivery device of claim 2, wherein the body member includes a connector that communicates the two single lumen tubes and the dual lumen tube.

4. A tympanic administration device according to claim 3, wherein said connector is a three-way connector, said connector connecting said single lumen tube and said dual lumen tube by welding; or the connecting piece is made of the same material as the double-cavity tube and the single-cavity tube, and the single-cavity tube is communicated with the double-cavity tube through adhesion.

5. The tympanometric drug delivery device of claim 1, wherein the surface of the main body member or/and the drug delivery sustained-release section is provided with a hydrophilic coating or an antibacterial coating.

6. The tympanogram drug delivery device of claim 1, wherein the main body piece and the drug delivery sustained-release part are made of latex, PU, TPU, silica gel, polylactic acid or glycolide-lactide copolymer.

7. The tympanometric drug delivery device of claim 1, comprising a first connector disposed at the proximal end of the access channel.

8. The tympanometric drug delivery device of claim 1, comprising a seal coupled to the proximal end of the intake channel and/or the proximal end of the exhaust channel.

9. The tympanometry drug delivery device of claim 1, wherein the fixing member has a through hole through which the body member passes, and the bore diameter of the through hole tapers from the distal side to the proximal side.

10. The tympanogram drug delivery device of claim 1, wherein the securing member is divided into a first section, a second section and a third section from the proximal end to the distal end, the first section comprising a cylindrical portion and an arcuate arm, the second section being cylindrical, the second section having a diameter smaller than the cylindrical portion of the first section, the third section being a flexible securing cap forming an arcuate surface of increasing diameter from the distal end to the proximal end.

11. The tympanogram drug delivery device of claim 1, wherein the drug delivery sustained release portion comprises an attachment end and a sustained release end, the attachment end is connected with the distal end of the main body member, the sustained release end is of a spherical structure, and the drug cavity is formed in the sustained release end.