Continuous dosing device in animal tympanic chamber

Abstract

The invention discloses a continuous administration device in an animal tympanic chamber. The continuous administration device comprises a catheter; the first end of the fixing mechanism is arranged on the side wall of the catheter, the first end of the fixing mechanism is attached to a tympanic membrane in the tympanic chamber, and the second end of the fixing mechanism is used for being fixed to the head of an animal; and the drug delivery mechanism is connected with the catheter, and the drug delivery mechanism continuously introduces drugs into the tympanic chamber through the catheter. The fixing device composed of the inflating inner bag, the shield plate, the inflating outer bag and the fixing piece is arranged, so that the drug delivery device is fixed to the tympanic membrane, damage to the inner ear in the drug delivery process is reduced, the integrity of the inner ear is guaranteed, and iatrogenic damage to the inner ear is reduced; the liquid medicine continuously and slowly enters the tympanic chamber through the catheter through the slow release device, and unnecessary waste caused by the fact that a large amount of liquid enters the tympanic chamber in a short time and the medicine overflows out of the auditory meatus is prevented.

Description

Technical Field

[0001] The invention relates to the technical field of tympanic cavity drug delivery devices, and in particular to a continuous drug delivery device for animal tympanic cavity. Background Art

[0002] The inner ear is located deep in the temporal bone. Due to the presence of the bony labyrinth and the membranous labyrinth, the endolymph is separated from the body fluids, and it is difficult for traditional drugs to enter the inner ear through the blood. Intratympanic injection is to inject liquid drugs into the middle ear cavity through the external auditory canal through the tympanic membrane by syringe, and then allow the drugs to penetrate into the inner ear through the round window membrane to achieve a higher drug concentration in the inner ear. However, due to the narrow middle ear cavity, it is difficult for traditional intratympanic injection to keep enough drugs in the tympanic cavity and continue to work. The liquid drugs that exceed the actual volume of the middle ear cavity overflow into the external auditory canal through the tympanic membrane puncture needle.

[0003] With the rapid development of biotechnology, drugs synthesized through gene editing and other technologies are expected to bring new breakthroughs in the treatment of inner ear diseases such as deafness. In terms of the choice of drug administration method, the commonly used injection through the round window or the external semicircular canal requires people or experimental animals to grind off part of the temporal bone under general anesthesia, open the round window or the external semicircular canal, and inject the drug into the inner ear through the round window membrane. This method is more damaging. In addition to increasing the risk of anesthesia and infection, it also destroys the integrity of the inner ear and may cause iatrogenic inner ear damage. Summary of the invention

[0004] The purpose of the present invention is to provide an animal intratympanic continuous drug delivery device to solve the problems of existing inner ear drug delivery methods that cause great damage, destroy the integrity of the inner ear, and may cause iatrogenic inner ear damage. Instead, the drug is delivered by slowly and continuously penetrating the drug solution through the round window membrane in the tympanic cavity into the inner ear.

[0005] To achieve the above object, the present invention is implemented through the following technical solutions:

[0006] The present invention provides an animal intratympanic continuous drug delivery device, comprising:

[0007] catheter;

[0008] A fixing mechanism, wherein a first end of the fixing mechanism is disposed on a side wall of the conduit, the first end of the fixing mechanism is in contact with a tympanic membrane in the tympanic cavity, and a second end of the fixing mechanism is used to be fixed on the head of an animal;

[0009] The drug administration mechanism is connected to the catheter, and the drug administration mechanism continuously passes the drug into the tympanic cavity through the catheter.

[0010] Preferably, the catheter comprises:

[0011] a guide wire disposed within the catheter;

[0012] a conduit outlet located at a first end of the conduit;

[0013] A cover plate is located at the second end of the catheter, and one end of the guide wire is arranged on the cover plate.

[0014] Preferably, the fixing mechanism comprises:

[0015] a scutum, which is in contact with the lateral wall of the tympanic membrane;

[0016] An inflatable inner balloon, which is located at the first end of the catheter, the inflatable inner balloon is passed into the inner side of the tympanic membrane in a contracted state, and the inflatable inner balloon is attached to the inner wall of the tympanic membrane in an expanded state;

[0017] An inflatable outer bag connected to the inflatable inner bag and used to convert the inflatable inner bag from a contracted state to an expanded state;

[0018] The fixing member is arranged at the second end of the catheter and is used for fixing on the head of the animal.

[0019] Preferably, the side wall of the conduit is provided with an inflation channel, and the inflation outer bag inputs gas into the inflation inner bag through the inflation channel.

[0020] Preferably, the inflatable outer bag comprises:

[0021] An air pump hose connected to the air pump channel;

[0022] An air storage bag, which is ellipsoidal in shape, one end of which is connected to the inflation hose;

[0023] The air intake mechanism is arranged at the other end of the air storage bag.

[0024] Preferably, the air intake mechanism comprises:

[0025] An air inlet, which is arranged on one side of the air storage bag;

[0026] A one-way valve air intake device is arranged in the air intake port.

[0027] Preferably, the one-way valve air intake device comprises:

[0028] An air storage bag connection port, one end of which is connected to the air storage bag;

[0029] A connecting tube, a first end of which is connected to the air storage bag connecting port, a second end of which is provided with a central fixing plate, and an air inlet hole is provided on the central fixing plate;

[0030] a spring, which is arranged in the connecting tube, one end of the spring is connected to a fixing seat, the fixing seat abuts against the central fixing plate, and the fixing seat covers the air inlet hole;

[0031] An air pump core has one end arranged in the air inlet hole.

[0032] Preferably, the one-way valve air intake device further comprises: an air pumping interface connected to the other end of the air pumping core.

[0033] Preferably, the drug delivery mechanism comprises:

[0034] A drug delivery barrel, wherein an elastic membrane and a baffle are arranged in the drug delivery barrel, wherein the elastic membrane encloses a closed area in the drug delivery barrel, wherein the baffle is arranged between the outer wall of the elastic membrane and the inner wall of the baffle, and wherein the baffle is a detachable structure, and wherein a semi-permeable membrane is arranged at the baffle;

[0035] A catheter connection port, one end of which is disposed in the elastic membrane and connected to the catheter;

[0036] The drug liquid injection hole is arranged on the side wall of the drug delivery cylinder, and the drug liquid is injected into the elastic membrane through the drug liquid injection hole.

[0037] Preferably, the elastic membrane and the baffle divide the inner cavity of the drug delivery barrel into three areas, and the three areas respectively include: a salt layer, a water layer and the drug solution in the elastic membrane.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] The present invention provides an animal intratympanic continuous drug delivery device, which fixes the drug delivery device at the tympanic membrane position by arranging a fixing device composed of an inflated inner bag, a shield plate, an inflated outer bag and a fixing piece, thereby reducing the damage to the inner ear caused during the drug delivery process, ensuring the integrity of the inner ear, and reducing iatrogenic inner ear damage. By arranging a drug delivery mechanism, liquid medicine can be continuously and slowly introduced into the tympanic cavity through a catheter via a sustained-release device, thereby preventing a large amount of liquid from entering the tympanic cavity in a short period of time and causing unnecessary waste of medicine overflowing from the ear canal. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solution of the present invention, the following briefly introduces the drawings required for the description. Obviously, the drawings described below are an embodiment of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative work:

[0041] Figure 1 A schematic diagram of a device for continuous drug delivery in the animal tympanic cavity provided by one embodiment of the present invention;

[0042] Figure 2 A schematic diagram of an inflated inner bag in an embodiment of the present invention;

[0043] Figure 3 A schematic diagram of the structure of an inflatable outer bag provided in one embodiment of the present invention;

[0044] Figure 4 A schematic diagram of the structure of a one-way valve air intake device provided in one embodiment of the present invention;

[0045] Figure 5 A schematic diagram of the structure of a drug delivery mechanism provided by one embodiment of the present invention;

[0046] Figure 6 A schematic structural diagram of a fixing member provided in one embodiment of the present invention;

[0047] Explanation of the reference numerals: 1-catheter, 101-cover plate, 102-guide wire, 103-inflating channel, 104-fixing part, 2-tympanic membrane, 3-external auditory canal, 4-dosing mechanism, 401-medicine injection hole, 402-water layer, 403-tube core, 404-catheter connecting port, 405-elastic membrane, 406-salt layer, 407-baffle, 408-semipermeable membrane, 409-medicine, 501-inflating outer bag, 5011-one-way valve air inlet device, 50111-air storage bag connecting port, 50112-spring, 50113-fixing seat, 50114-central fixing plate, 50115-inflating core, 50116-inflating interface, 50117-connecting tube, 5012-air storage bag, 5013-inflating hose, 502-shield plate, 503-inflating inner bag. DETAILED DESCRIPTION

[0048] The following is combined with Figure 1-6 The animal intratympanic continuous drug delivery device proposed by the present invention is further described in detail in the following specific embodiments. According to the following description, the advantages and features of the present invention will be clearer. It should be noted that the drawings are in a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In order to make the purposes, features and advantages of the present invention more obvious and easy to understand, please refer to the drawings. It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no technical substantive significance. Any structural modification, change in proportional relationship or adjustment of size, without affecting the effects that the present invention can produce and the purposes that can be achieved, should still fall within the scope of the technical content disclosed by the present invention.

[0049] This embodiment mainly solves the problem that the existing inner ear drug administration method is very damaging, destroys the integrity of the inner ear, and may cause iatrogenic inner ear damage.

[0050] refer to Figure 1As shown, this embodiment provides a device for continuous drug delivery into the tympanic cavity of an animal, comprising: a catheter 1; a fixing mechanism, a first end of which is arranged on the side wall of the catheter 1, and the first end of the fixing mechanism is in contact with the tympanic membrane 2 in the tympanic cavity, and the second end of the fixing mechanism is used to be fixed on the head of the animal; a drug delivery mechanism 4, which is connected to the catheter 1, and the drug delivery mechanism 4 continuously passes the drug into the tympanic cavity through the catheter 1.

[0051] Continue to refer Figure 1 As shown, the catheter 1 includes: a guide wire 102, which is arranged in the catheter 1, and the guide wire 102 is used to maintain the shape of the catheter 1 so that the catheter 1 can smoothly enter the animal's tympanic cavity. The hard guide wire 102 is used to guide the entire catheter 1 into the tympanic membrane, and then the guide wire 102 is withdrawn, and the cover plate 101 is closed, so that the catheter 1 is in a relatively soft state in the animal's external auditory canal during the subsequent continuous drug administration process to avoid damaging the ear canal; a catheter outlet, which is located at the first end of the catheter; a cover plate 101, which is located at the second end of the catheter 1, and one end of the guide wire 102 is arranged on the cover plate 101. After the catheter 1 is punctured into place, the cover plate 101 is opened, and after the guide wire 102 is taken out, refer to Figure 2 As shown, a plug is provided at the second end of the catheter 1 . After the guide wire 102 and the cover plate 101 are taken out, the plug is installed at the original position of the cover plate 101 to ensure that the second end of the catheter 1 is sealed.

[0052] refer to Figure 1 and Figure 2 As shown, the fixing mechanism includes: a shield plate 502, which is in contact with the outer wall of the tympanic membrane 2. Under the limiting effect of the shield plate 502, the guide wire 102 in the catheter 1 is prevented from being excessively inserted into the tympanic membrane 2 and entering the tympanic cavity to damage important structures such as the promontory. The distance from the first end of the catheter 1 to the shield plate 502 can be designed to be different lengths according to the type of animal to ensure effective puncture into the tympanic membrane 2 without damaging important structures in the tympanic cavity; an inflated inner balloon 503, which is located at the first end of the catheter 1. The inflated inner balloon 503 is passed into the inner side of the tympanic membrane 2 in a contracted state, and the inflated inner balloon 503 is in contact with the inner wall of the tympanic membrane 2 in an expanded state; an inflated outer balloon 501, which is connected to the inflated inner balloon 503 and is used to convert the inflated inner balloon 503 from a contracted state to an expanded state; a fixing member 104, which is arranged at the second end of the catheter 1 and is used to be fixed to the head of the animal. For details, refer to Figure 6 The side wall of the conduit is provided with an air-inflating channel 103 , and the air-inflating outer bag 501 inputs gas into the air-inflating inner bag 503 through the air-inflating channel.

[0053] refer to Figure 3As shown, the outer inflation bag 501 includes: an inflation hose 5013, which is connected to the inflation channel 103; an air storage bag 5012, which is ellipsoidal, and one end of the air storage bag 5012 is connected to the inflation hose 5013; and an air intake mechanism, which is arranged at the other end of the air storage bag.

[0054] refer to Figure 4 As shown, the air intake mechanism includes: an air intake port, which is arranged on one side of the air storage bag; a one-way valve air intake device 5011, which is arranged in the air intake port. The one-way valve air intake device 5011 includes: an air storage bag connection port 50111, one end of which is connected to the air storage bag 5012; a connecting tube 50117, a first end of which is connected to the air storage bag connection port 50111, and a central fixing plate 50114 is arranged at the second end of the connecting tube 50117, and an air intake hole is opened on the central fixing plate 50114; a spring 50112 is arranged in the connecting tube 50117, one end of the spring 50112 is connected to a fixing seat, the fixing seat 50113 abuts against the central fixing plate 50114, and the fixing seat covers the air intake hole; an air pumping core 50115, one end of which is arranged in the air intake hole and cooperates with the air intake hole. The one-way valve air intake device 5011 also includes: an air pumping interface 50116, which is connected to the other end of the air pumping core 50115.

[0055] refer to Figure 4 As shown, the drug delivery mechanism 4 includes: a drug delivery barrel, wherein an elastic membrane 405 and a baffle 407 are arranged in the drug delivery barrel, wherein the elastic membrane 405 encloses a closed area in the drug delivery barrel, wherein the baffle 407 is arranged between the outer wall of the elastic membrane 405 and the inner wall of the drug delivery barrel, and wherein the baffle 407 is a detachable structure, wherein a semipermeable membrane 408 is arranged at the baffle 407; a catheter connection port 404, which is arranged in the elastic membrane 405 and connected to the catheter; and a drug solution injection hole 401, which is arranged in the side wall of the drug delivery barrel, and the drug solution is injected into the elastic membrane 405 through the drug solution injection hole 401. The elastic membrane 405 and the baffle 407 divide the inner cavity of the drug delivery barrel into three areas, wherein the three areas respectively include: a salt layer 406, a water layer 402, and the drug solution in the elastic membrane 405. The liquid medicine is filled into the inside of the drug delivery mechanism through the liquid medicine injection hole 401 by the syringe. When the medicine needs to enter the tympanic cavity, the baffle 407 is pulled out from the drug delivery mechanism. At this time, the water layer 402 enters the salt layer 406 along the semipermeable membrane. The elastic membrane 405 is between the salt layer 406 and the liquid medicine. After the volume of the salt layer 406 increases, the elastic membrane 405 is pressed to squeeze the internal liquid medicine, and the liquid medicine enters the catheter 1 through the catheter connection port 404. The drug delivery mechanism 4 in this embodiment constitutes a sustained-release device for continuous drug delivery, so that the liquid medicine enters the tympanic cavity continuously and slowly through the catheter 1 through the sustained-release device, thereby preventing a large amount of liquid from entering the tympanic cavity in a short period of time and eventually overflowing from the ear canal to cause waste.

[0056] The working principle of the device for continuous drug delivery in the animal tympanic cavity in this embodiment is as follows: when the tympanic membrane 2 is not punctured, the guide wire 102 is inserted into the catheter 1, the catheter 1 is kept straight and sharp, and the cover plate 101 is kept in a fixed and compressed state. After puncturing the tympanic membrane 2, the shield plate 502 limits the position to prevent the puncture needle tip from excessively inserting into the tympanic membrane 2 and entering the tympanic cavity to damage important structures such as the promontory. The distance from the end of the catheter 1 to the shield plate 503 can be designed to different lengths according to the type of animal to ensure effective puncture into the tympanic membrane 2 without damaging important structures in the tympanic cavity. After the puncture is in place, the cover plate 101 is opened, and after the guide wire 102 is pulled out, the cover plate 101 is closed to ensure the sealing of the outer opening of the catheter 1. Use a syringe to pump air into the outer inflation bag 501, so that the gas enters the inner inflation bag 503 through the inflation channel 103 on the outer wall of the catheter 1. The inner inflation bag 503 expands in the inflated state, and the inner inflation bag 503 and the shield plate 502 play a role in fixing and limiting the eardrum to prevent the device from falling out of the eardrum. When inflating, the head of the syringe is tightly connected to the inflation interface 50116, so that it pushes the spring 50112, exposing the inner opening of the inflation core 50115 to the air storage bag connection port 50111, and at this time, the gas enters the inflation hose 5013 from the syringe. After the syringe is pulled out, the spring 50112 restores its natural length, so that the fixing seat 50113 fits the central fixing plate 50114, preventing the gas entering the inflation hose 5013 from leaking out. The drug delivery mechanism connected to the end of the catheter 1 has a semipermeable membrane device as its core. The drug solution is filled into the drug delivery mechanism from the drug solution injection hole 401 through a syringe. When the drug needs to enter the tympanic cavity, the baffle 407 is pulled out from the drug delivery mechanism. At this time, the water layer 402 enters the salt layer 406 along the semipermeable membrane 408. There is an elastic membrane 405 between the salt layer 406 and the drug solution. After the volume of the salt layer 406 increases, the elastic membrane 405 is pressed to squeeze the internal drug solution, and the drug solution enters the catheter 1 through the catheter connection port 404. Before drug injection, the tail end of the catheter 1 extending out of the external auditory canal is passed through the fixing piece 104 and hung and fixed on the skin of the animal's head. During the specific operation, the skin of the animal's head is lifted, and a part of the skin is connected to the hole in the center of the fixing piece 104 with a leather nail to prevent the device from falling off when the animal moves.

[0057] In summary, this embodiment proposes a continuous drug delivery device within the animal's tympanic cavity. By providing a fixing device consisting of an inflated inner bag, a shield plate, an inflated outer bag and a fixing part, the drug delivery device is fixed at the tympanic membrane position, thereby reducing the damage to the inner ear caused during the drug delivery process, ensuring the integrity of the inner ear, and reducing iatrogenic inner ear damage. By providing a drug delivery mechanism, liquid drugs can be continuously and slowly introduced into the tympanic cavity through a catheter via a sustained-release device, thereby preventing a large amount of liquid from entering the tympanic cavity in a short period of time and causing unnecessary waste of drugs overflowing from the ear canal.

[0058] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0059] It should be noted that the devices and methods disclosed in the embodiments of this article can also be implemented in other ways. The device implementation described above is only schematic. For example, the flowcharts and block diagrams in the accompanying drawings show the possible architecture, functions and operations of the devices, methods and computer program products according to multiple embodiments of this article. In this regard, each box in the flowchart or block diagram can represent a part of a module, program or code, and the module, program segment or part of the code contains one or more executable instructions for implementing the specified logical function, and the module, program segment or part of the code contains one or more executable instructions for implementing the specified logical function. It should also be noted that in some alternative implementations, the functions marked in the box can also occur in a different order from the order marked in the accompanying drawings. For example, two consecutive boxes can actually be executed substantially in parallel, and they can sometimes be executed in the opposite order, depending on the functions involved. It should also be noted that each box in the block diagram and / or flowchart, and the combination of boxes in the block diagram and / or flowchart can be implemented by a dedicated hardware-based system for performing a specified function or action, or can be implemented by a combination of dedicated hardware and computer instructions.

[0060] In addition, the functional modules in the various embodiments of this document may be integrated together to form an independent part, or each module may exist independently, or two or more modules may be integrated to form an independent part.

[0061] Although the content of the present invention has been described in detail through the above preferred embodiments, it should be appreciated that the above description should not be considered as a limitation of the present invention. After reading the above content, it will be apparent to those skilled in the art that various modifications and substitutions of the present invention will occur. Therefore, the protection scope of the present invention should be limited by the appended claims.

Claims

1. A device for continuous drug delivery in the tympanic cavity of an animal, characterized in that: include: catheter; A fixing mechanism, wherein a first end of the fixing mechanism is disposed on a side wall of the conduit, the first end of the fixing mechanism is in contact with a tympanic membrane in the tympanic cavity, and a second end of the fixing mechanism is used to be fixed on the head of an animal; The drug administration mechanism is connected to the catheter, and the drug administration mechanism continuously passes the drug into the tympanic cavity through the catheter.

2. The device for continuous drug delivery in the animal tympanic cavity according to claim 1, characterized in that: The catheter comprises: a guide wire disposed within the catheter; a conduit outlet located at a first end of the conduit; A cover plate is located at the second end of the catheter, and one end of the guide wire is arranged on the cover plate.

3. The device for continuous drug delivery in the animal tympanic cavity according to claim 1, characterized in that: The fixing mechanism comprises: a scutum, which is in contact with the lateral wall of the tympanic membrane; An inflatable inner balloon, which is located at the first end of the catheter, the inflatable inner balloon is passed into the inner side of the tympanic membrane in a contracted state, and the inflatable inner balloon is attached to the inner wall of the tympanic membrane in an expanded state; An inflatable outer bag connected to the inflatable inner bag and used to convert the inflatable inner bag from a contracted state to an expanded state; The fixing member is arranged at the second end of the catheter and is used for fixing on the head of the animal.

4. The device for continuous drug delivery in the animal tympanic cavity according to claim 3, characterized in that: The side wall of the conduit is provided with an inflation channel, and the inflation outer bag inputs gas into the inflation inner bag through the inflation channel.

5. The device for continuous drug delivery in the animal tympanic cavity according to claim 4, characterized in that: The inflatable outer bag comprises: An air pump hose connected to the air pump channel; An air storage bag, one end of which is connected to the air pump hose; The air intake mechanism is arranged at the other end of the air storage bag.

6. The device for continuous drug delivery in the animal tympanic cavity according to claim 5, characterized in that: The air intake mechanism comprises: An air inlet, which is arranged on one side of the air storage bag; A one-way valve air intake device is arranged in the air intake port.

7. The device for continuous drug delivery in the animal tympanic cavity according to claim 6, characterized in that: The one-way valve air intake device comprises: An air storage bag connection port, one end of which is connected to the air storage bag; A connecting tube, a first end of which is connected to the air storage bag connecting port, a second end of which is provided with a central fixing plate, and an air inlet hole is provided on the central fixing plate; a spring, which is arranged in the connecting tube, one end of the spring is connected to a fixing seat, the fixing seat abuts against the central fixing plate, and the fixing seat covers the air inlet hole; An air pump core has one end arranged in the air inlet hole.

8. The device for continuous intratympanic drug delivery in animals according to claim 7, characterized in that: The one-way valve air intake device also includes: an air pumping interface, which is connected to the other end of the air pumping core.

9. The device for continuous drug delivery in the animal tympanic cavity according to claim 1, characterized in that: The drug delivery mechanism comprises: A drug delivery barrel, wherein an elastic membrane and a baffle are arranged in the drug delivery barrel, wherein the elastic membrane encloses a closed area in the drug delivery barrel, wherein the baffle is arranged between the outer wall of the elastic membrane and the inner wall of the baffle, and wherein the baffle is a detachable structure, and wherein a semi-permeable membrane is arranged at the baffle; A catheter connection port, one end of which is disposed in the elastic membrane and connected to the catheter; The drug liquid injection hole is arranged on the side wall of the drug delivery cylinder, and the drug liquid is injected into the elastic membrane through the drug liquid injection hole.

10. The device for continuous intratympanic drug delivery in animals according to claim 9, characterized in that: The elastic membrane and the baffle divide the inner cavity of the drug delivery cartridge into three areas, and the three areas respectively include: a salt layer, a water layer and the drug solution in the elastic membrane.

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