Accurate regulation and control injection device for extraocular muscle toxin

Abstract

The invention discloses a precise regulation and control injection device for extraocular muscle toxin, and belongs to the technical field of medical instruments. The precise regulation and control injection device for extraocular muscle toxin comprises a microneedle assembly, a handle, a suction head and an injection regulation and control part, wherein the injection regulation and control part is used for controlling the microneedle assembly to be connected with the suction head. When the precise regulation and control injection device for the extraocular muscle toxin is used, the micro-needle assembly can be in suction connection with the suction head arranged at the tail end of the handle through adjustment of the injection regulation and control part, so that in the process that an operator injects the extraocular muscle toxin to a patient, it is ensured that a micro-needle does not deviate or loosen in the injection process, and the injection efficiency is improved. The precise positioning of an injection part is ensured; and the injection regulation and control part can regulate the action range of the microneedle on the microneedle assembly to be more concentrated, so that the concentration of the action range of the medicine and the accurate delivery of the medicine to the target muscle layer can be ensured, the out-of-control diffusion of the medicine is avoided, and the risk of penetrating through the sclera is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an extraocular muscle toxin precise regulation injection device. BACKGROUND

[0002] As an important means of treating strabismus and diplopia, extraocular muscle toxin injection faces many challenges in clinical practice.

[0003] For extraocular muscle toxin injection, traditional injection techniques require patients to receive treatment in a conscious state, and to witness the scene of a long needle puncturing the eyeball. This visual stimulation often triggers strong "needle phobia", which seriously affects patient treatment compliance. At the same time, due to the complex and delicate anatomy of the eye, traditional blind injection or electromyography-guided methods highly depend on the operating experience of doctors. Any slight mistake may result in inaccurate injection levels, increase the possibility of drug diffusion to non-target areas, and even pose a risk of penetrating the eyeball and damaging the retina, causing serious complications to patients.

[0004] Meanwhile, the patent with publication number CN221470580U discloses an extraocular muscle toxin injection forceps, which is characterized in that the working end of one forceps piece is integrally provided with a blocking pad for blocking outside the eyeball, and the working end of the other forceps piece is integrally provided with a holding part for holding the extraocular muscle together with the blocking pad. When in use, the blocking pad is inserted between the exposed extraocular muscle and the eyeball, and after holding the extraocular muscle, the holding part side can have part of the extraocular muscle that remains stable with the holding part. The injection needle can be inserted into this part of the extraocular muscle for needle injection, so that the needle can quickly penetrate the extraocular muscle, reducing the injection penetration depth and improving the safety of surgical operation.

[0005] The above-mentioned prior art is an extraocular muscle toxin injection forceps for improving the safety of surgical operation. However, the existing device requires continuous clamping operation of the forceps piece and insertion of the pad under the extraocular muscle, which not only causes pain to the patient, but also increases the risk of oculocardiac reflex due to the pulling disturbance of the extraocular muscle, causing damage to the patient. SUMMARY

[0006] The purpose of the present application is to overcome the problems in the prior art and provide an extraocular muscle toxin precise regulation injection device that can avoid the defects of the existing device, such as the need for continuous clamping operation of the forceps piece and the need for insertion of the pad under the extraocular muscle, thereby ensuring precise drug delivery to the target muscle layer, reducing the risk of penetrating the sclera, and significantly improving operation efficiency and treatment comfort.

[0007] The main idea of the technical scheme adopted by the application is: in view of the defects that the existing device needs to use tweezers for continuous clamping operation, and the gasket isolation must be inserted under the extraocular muscle, which causes pain to the patient and increases the risk of eye-heart reflex, a kind of extraocular muscle toxin precise regulation injection device is designed, which comprises a microneedle assembly and an injection regulation part. The microneedle assembly and the handle of the device are stably connected through the injection regulation part, so that the microneedle does not deviate or loosen during injection, the precise positioning of the injection site is ensured, and the drug of the microneedle assembly is precisely delivered to the injection site of the extraocular muscle toxin of the patient through the adjustment and control of the injection regulation part. The defects that the existing device needs to use tweezers for continuous clamping operation, and the gasket isolation must be inserted under the extraocular muscle, which causes pain to the patient, and the pulling disturbance of the extraocular muscle increases the risk of eye-heart reflex, so that the operation efficiency, treatment comfort and treatment safety are significantly improved.

[0008] In order to achieve the above purpose, the technical scheme adopted by the application is as follows: An extraocular muscle toxin precise regulation injection device comprises a handle, and further comprises: a suction head arranged at the end of the handle; a microneedle assembly connected with the suction head; an injection regulation part arranged on the handle, used for controlling the connection of the microneedle assembly and the suction head, and adjusting and controlling the delivery of the drug of the microneedle assembly to the injection site of the extraocular muscle toxin of the patient.

[0009] Based on the above technical scheme, further, the inside of the handle is a cavity structure, which is divided into an upper cavity and a lower cavity, the upper cavity and the lower cavity are separated by a partition plate, an inner sleeve is arranged in the lower cavity, the lower cavity is divided into a disinfectant chamber and a central chamber, and the disinfectant chamber and the central chamber are respectively communicated with the upper cavity through air holes.

[0010] Based on the above technical scheme, further, a plurality of suction holes are arranged at the end of the central chamber; a disinfectant suction hole is arranged at the end of the disinfectant chamber, the disinfectant suction hole is located on the surface of the suction head, and is distributed in an inner-outer ring mode with the suction hole.

[0011] Based on the above technical scheme, further, the injection regulation part comprises: an outer ring piston sleeved on the outer wall of the inner sleeve and located in the inside of the disinfectant chamber; an inner ring piston arranged on the inner wall of the inner sleeve and located in the inside of the central chamber; an adjusting assembly arranged in the upper cavity of the handle, used for adjusting the connection of the microneedle assembly and the suction head.

[0012] Based on the above technical scheme, further, the adjusting assembly comprises: The movable plate is arranged inside the upper cavity, and a push rod is arranged on the top of the movable plate, and the end of the push rod penetrates to the front end of the handle and is connected with the adjusting knob; The negative pressure suction assembly is communicated with the upper cavity below the movable plate through the communication pipe.

[0013] Based on the above technical scheme, further, a thread is arranged on the rod body of the push rod, and the front end of the handle is threadedly connected with the rod body of the push rod Based on the above technical scheme, further, the microneedle assembly comprises: The base, the microneedle and the air bag are respectively arranged on both sides of the base.

[0014] Based on the above technical scheme, further, the position of the air bag corresponds to the position of the suction hole.

[0015] Compared with the prior art, the beneficial effects of the present application are: 1. The eye muscle toxin precise control injection device of the present application comprises a microneedle assembly, a suction head, a handle and an injection control part, the suction head is connected with the handle, and the microneedle assembly is tightly and stably connected with the end surface of the suction head through the injection control part, on the premise of ensuring pure mechanical operation, the defects of the existing device, such as the need for continuous clamping operation of tweezers and excessive dependence on operator experience, can be avoided, the microneedle can be prevented from deviating and loosening during the injection process, the precise positioning of the injection site can be ensured, the concentration of the drug action range can be ensured to precisely deliver the drug to the target muscle layer, the risk of penetrating the sclera can be avoided, and the operation efficiency and treatment comfort are significantly improved.

[0016] 2. The end surface of the suction head is a flexible structure, and the convex surface structure of the end surface of the suction head is arranged on the suction head, through the design that the end surface of the suction head is convex, in the process of connecting the microneedle assembly with the suction head, due to the adjusting action of the injection control part, the end surface of the suction head changes from convex to concave, and the end surface of the microneedle assembly connected with the suction head also changes from convex to concave, so that the action range of the microneedle arrangement area on the microneedle assembly is reduced, and the needling area is concentrated, thereby avoiding the injury to the tissues around the eye.

[0017] 3. The disinfectant cavity and the central cavity are respectively communicated with the upper cavity through the ventilation holes, the number of the ventilation holes through which the central cavity is communicated with the upper cavity is more than the number of the ventilation holes through which the disinfectant cavity is communicated with the upper cavity, through the difference design of the number of the ventilation holes, when the negative pressure suction assembly is started, the inner ring piston is first pushed to separate the microneedle assembly from the suction head, after the microneedle assembly is separated, the outer ring piston pushes out the disinfectant in the disinfectant cavity to disinfect the end surface of the suction head, so that through the time delay of the activities of the outer ring piston and the inner ring piston, the disinfectant is prevented from being pushed out by the movement of the inner ring piston in the process of needle extraction, and the disinfection of the suction head after the injection is completed is realized. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 The overall structure schematic diagram of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 2 The first cross-sectional structure schematic diagram of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 3 The second cross-sectional structure schematic diagram of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 4 The cross-sectional structure schematic diagram of the eye muscle toxin precise regulation injection device in the embodiment of the application Figure 3 The enlarged structure schematic diagram of the lower half part; Figure 5 The structure schematic diagram of the eye muscle toxin precise regulation injection device without the microneedle assembly in the embodiment of the application; Figure 6 The cross-sectional structure schematic diagram of the eye muscle toxin precise regulation injection device in the embodiment of the application Figure 5 Figure 7 The connection structure schematic diagram of the movable plate, negative pressure pump, connecting rod and knob of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 8 The structure schematic diagram of the inner ring piston and outer ring piston of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 9 The connection structure schematic diagram of the handle and suction head of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 10 The cross-sectional structure schematic diagram of the eye muscle toxin precise regulation injection device in the embodiment of the application Figure 9

[0019] Figure 11 The structure schematic diagram of the suction head of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 12 The structure schematic diagram of the microneedle assembly of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 13 The schematic diagram of the use state of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 14 The structure schematic diagram of the three-dimensional modeling of the eye muscle toxin precise regulation injection device in the embodiment of the application; Figure 15 The three-dimensional modeling schematic diagram of the use state of the eye muscle toxin precise regulation injection device in the embodiment of the application; Explanation of reference signs: ​​1. A microneedle assembly, 101. Microneedle, 102. Base, 103. Airbag, 2. Handle, 3. Knob, 4. Push rod, 5. Negative pressure pump, 6. Connecting tube, 7. Movable plate, 8. Central cavity, 9. Inner sleeve, 10. Disinfectant cavity, 11. Outer ring piston, 12. Inner ring piston, 13. Suction head, 14. Disinfectant hole, 15. Suction hole, 16. Eye. DETAILED DESCRIPTION

[0020] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions of the embodiments of the present application will be described clearly and completely below with reference to the drawings of the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the described embodiments of the present application, all other embodiments obtained by a person of ordinary skill in the art without creative effort belong to the scope of protection of the present application.

[0021] Unless otherwise defined, technical terms or scientific terms used herein should be understood as having the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terms "comprise", "comprising", and like terms are intended to mean that the elements or objects listed after such terms encompass the elements or objects listed after such terms, as well as equivalents thereof, and do not preclude the presence or addition of other elements or objects. The terms "in", "out", "upper", "lower", "far", "near", "front", "back", and the like are only used to indicate relative positional relationships, and when the absolute positions of the described objects are changed, the relative positional relationships may also be changed accordingly.

[0022] The drawings in the present application are not strictly drawn according to the actual proportions, and the specific sizes and quantities of various structures can be determined according to actual needs. The drawings described in the present application are only structural schematic diagrams.

[0023] Although the existing extraocular muscle toxin injection forceps can ensure that the needle can quickly penetrate into the extraocular muscle by inserting a gasket between the exposed visible extraocular muscle and the eyeball, reduce the injection penetration depth, and thus improve the safety of the operation, the inventors have found through research that the existing extraocular muscle toxin injection device has the following problems in actual use: continuous clamping operation of the forceps is required, and the gasket must be inserted under the extraocular muscle, which not only causes pain to the patient, but also increases the risk of oculocardiac reflex when the injection needle is used for needle injection, causing damage to the patient.

[0024] Based on the above findings, the inventors conceived of designing a device for precise control of extraocular muscle toxin injection. This device avoids the shortcomings of existing devices, such as the need for continuous clamping with forceps, the requirement for inserting a pad under the extraocular muscle which causes pain to the patient, and the increased risk of oculocardiac reflex due to traction and disturbance of the extraocular muscle, which can cause damage to the patient. This device ensures precise delivery of the drug to the target muscle layer, reduces the risk of scleral penetration, and significantly improves operational efficiency and treatment comfort.

[0025] See attached document Figures 1-15 The present invention provides a device for precise control of extraocular muscle toxin injection, comprising: Handle 2; A suction head 13 is located at the end of the handle 2. The suction head 13 is threadedly connected to the handle 2. The end face of the suction head 13 is a flexible structure and a convex structure. Microneedle component 1 is connected to suction head 13. Microneedle component 1 is used to puncture the injection site of the patient's extraocular muscle and release the drug after puncture, so as to achieve precise delivery of the drug to the target muscle layer. An injection control unit, located on the handle 2, is used to control the connection between the microneedle assembly 1 and the suction head 13.

[0026] Specifically, referring to the accompanying drawings, when the suction head 13 is not connected to the microneedle assembly suction head 13, the end face of the suction head 13 is a convex structure. During the process of connecting the microneedle assembly 1 to the suction head 13, due to the adjustment function of the injection control unit, the end face of the suction head changes from convex to concave. The end face of the microneedle assembly 1 connected to the suction head 13 also changes from convex to concave as the end face of the suction head changes. This reduces the effective range of the microneedle arrangement area on the microneedle assembly and concentrates the needling area, thereby avoiding accidental injury to the tissues around the eyes.

[0027] This application discloses a precise control injection device for extraocular muscle toxins. During use, the injection control unit adjusts the microneedle assembly 1 to connect with the suction head 13 at the end of the handle 2. This ensures a stable connection between the microneedle assembly 1 and the handle 2 during extraocular muscle toxin injection, preventing the microneedles from shifting or loosening and guaranteeing precise injection site positioning. The suction head 13, located at the end of the handle 2, has a flexible, convex end face. After the microneedle assembly and suction head 13 are stably connected, the injection control unit adjusts the suction head, causing the convex surface to become concave. This reduces the effective area of ​​the microneedles on the assembly, concentrating the needling area. To avoid accidental damage to tissues around the eye, the device delivers the drug to the extraocular muscle toxin injection site via the microneedle assembly 1 through the handheld handle 2. This device combines microneedle technology with the mechanical control of the microneedle control unit to achieve a stable connection between the microneedle and the handle, ensuring precise positioning of the injection site. It avoids the shortcomings of existing devices, such as the need for continuous clamping with forceps, the requirement for inserting a pad under the extraocular muscle which causes pain to the patient, and the increased risk of oculocardiac reflex due to traction and disturbance of the extraocular muscle. Furthermore, the injection control unit can adjust the effective range of the microneedles on the microneedle assembly to be more concentrated, thereby ensuring the concentration of the drug's effective range and the precise delivery of the drug to the target muscle layer, avoiding uncontrolled drug diffusion, and reducing the risk of scleral penetration.

[0028] The device in this application embodiment avoids the shortcomings of existing devices that require continuous clamping with forceps and require the pad to be inserted below the extraocular muscle first. These defects not only cause pain to the patient but also increase the risk of oculocardiac reflex and damage due to traction and disturbance of the extraocular muscle. The device ensures accurate delivery of drugs to the target muscle layer, avoids uncontrolled drug diffusion and reduces the risk of scleral penetration, thereby significantly improving operational efficiency, treatment comfort and treatment safety.

[0029] Based on the above technical solutions, further refer to the appendix. Figures 1-15 As shown in the embodiment of this application, the handle 2 has a hollow structure inside, which is divided into an upper cavity and a lower cavity. The upper cavity and the lower cavity are separated by a partition. An inner sleeve 9 is provided in the lower cavity, which divides the lower cavity into a disinfectant chamber 10 and a central cavity 8. The disinfectant chamber 10 and the central cavity 8 are respectively connected to the upper cavity through vent holes.

[0030] It should be noted that the inner sleeve 9 in the application is integrally formed with the handle 2, the handle 2 is a two-segment structure, a partition plate is arranged in the internal passage, the handle 2 is divided into an upper segment and a lower segment, the upper segment is an upper cavity, the lower segment is a lower cavity, the inner sleeve 9 is arranged in the lower cavity, when the inner sleeve 9 is assembled with the handle 2, the inner sleeve 9 is first assembled with the partition plate, then the lower segment of the handle 2 is assembled to one side of the inner sleeve 9, finally the upper segment of the handle 2 is assembled to the other side, the assembly of the handle 2 is completed, and the handle 2 and the inner sleeve 9 can be assembled and connected in the form of welding to form an integral structure.

[0031] Specifically, referring to the content shown in the drawings, the lower end of the inner sleeve 9 in the application is in butt joint with the connecting portion inside the suction head 13, the end face of the suction head 13 is a flexible structure, the suction head 13 is threadedly connected with the handle 2, the inner side of the suction head 13 is provided with the connecting portion, the connecting portion is a cylindrical structure, and the inner diameter of the connecting portion is greater than the outer wall size of the inner sleeve 9, after the disinfectant is injected into the disinfectant cavity 10, the end of the handle is upward, and the suction head 13 is threadedly connected with the handle 2, at this time, the connecting portion is matched and connected with the inner sleeve 9, the disinfectant is located in the disinfectant cavity 10, and the disinfectant is pushed out of the disinfectant cavity 10 by the pushing action of the injection control portion, so that the end face of the suction head 13 is disinfected.

[0032] In the embodiment of the application, the end of the central cavity 8 is provided with a plurality of suction holes 15 for suction connection of the microneedle assembly 1, specifically, the suction holes 15 are located at the bottom end face of the central cavity 8, and the suction holes 15 are used to suck the microneedle assembly 1 to the suction head 13 under the pushing action of the injection control portion, so as to ensure the stable connection of the microneedle assembly 1 and the handle 2.

[0033] The disinfectant cavity 14 is filled with disinfectant, which is used to disinfect the end face of the suction head 13 for suctioning the microneedle assembly 1, so as to remove the residual microorganisms on the suction head 13 and prevent cross infection in the treatment process.

[0034] Specifically, the end of the disinfectant cavity 10 is provided with a disinfectant suction hole 14, the disinfectant suction hole 14 is located on the surface of the suction head 13 and is distributed in an inner-outer ring with the suction hole 15, in use, the disinfectant is injected into the disinfectant cavity by unscrewing the suction head 13, and the suction head 13 is tightened, since the disinfectant suction hole 14 is a one-way hole, the disinfectant will not flow out of the disinfectant hole 14 without external force.

[0035] Further, referring to the content shown in the drawings, the injection control portion in the embodiment of the application is arranged on the handle 2, the injection control portion comprises: The outer ring piston 11 is sleeved on the outer wall of the inner sleeve 9 and located inside the disinfectant cavity 10, and the disinfectant is located in the region between the outer ring piston 11 and the end face of the suction head 13; The inner ring piston 12 is sleeved with the inner wall of the inner sleeve 9 and located inside the central cavity 8. The adjusting assembly is arranged at the end of the handle 2.

[0036] Further, with reference to the content shown in the drawings, the adjusting assembly in the embodiment of the application comprises: The movable plate 7 is arranged inside the upper cavity, and the top of the movable plate 7 is provided with the push rod 4, and the end of the push rod 4 penetrates to the front end of the handle and is connected with the adjusting knob 3.

[0037] The push rod 4 is provided with a thread on the rod body and is screwed with the front end of the handle.

[0038] The negative pressure suction assembly is communicated with the upper cavity below the movable plate 7, and in use, by rotating the adjusting knob 3, the movable plate 7 is driven by the push rod 4 to move inside the handle 2, so as to adjust the initial volume of the upper cavity below the movable plate 7, to change the negative pressure suction of the negative pressure suction assembly to the inside of the handle 2, so as to change the limitation of the microneedle assembly when the device in the embodiment of the application is used for botulinum toxin injection to the patient, to ensure the stable penetration of the hand.

[0039] Based on the above technical scheme, in use of the device of the application, the inner ring piston 11 arranged in the central cavity 8 and the outer ring piston 13 in the disinfectant cavity are moved by the negative pressure suction of the negative pressure suction assembly; then the microneedle assembly 1 is placed at the end of the handle 2 and close to the end of the handle 2, the air bag 103 on the microneedle assembly is squeezed to pass through the suction hole 15 by the negative pressure suction of the negative pressure suction assembly, to realize the effective connection of the microneedle assembly and the handle, then the distance of the handle forward movement (the size of the injection force) is manually controlled, so as to limit the penetration depth of the microneedle, to avoid the out-of-control diffusion of the drug and reduce the risk of penetrating the sclera, to significantly improve the operation efficiency, the treatment comfort and the safety of the treatment.

[0040] Based on the above technical scheme, it needs to be explained that the number of the air vents of the central cavity 8 in communication with the upper cavity is more than the number of the air vents of the disinfectant cavity 10 in communication with the upper cavity, that is, when the negative pressure device is started, due to the air amount entering the central cavity 8 is more than the air amount entering the disinfectant cavity at the same time, under the action of negative pressure, the inner ring piston 12 is pushed down first, and the air bag 103 of the microneedle assembly 1 is pushed off from the suction hole 15 of the suction head, that is, after the injection is completed, the device is moved away from the eye, and then the pressure is continuously released through the adjusting assembly to make the microneedle assembly 1 fall off from the suction head 13 and be discarded, and since the number of the air vents above the disinfectant cavity is small, when the negative pressure suction assembly is started, the inner ring piston 12 will start to move first, and push the microneedle assembly off from the suction hole 15, and the outer ring piston 11 moves with a delay, and after the microneedle assembly falls off, the outer ring piston pushes the disinfectant in the disinfectant cavity to disinfect the end face of the suction head, so that through the certain delay of the outer ring piston and the inner ring piston 12, the disinfectant is prevented from being pushed out by the movement of the inner ring piston during the needle releasing process.

[0041] In the device handle 2 in the embodiment of the application, the lower cavity has a double-layer structure of the central cavity 8 and the disinfectant cavity 10, and the outer ring piston 11 and the inner ring piston 12 are arranged in the central cavity 8 and the disinfectant cavity 14 respectively, and through the differential design of the double pistons between the outer ring piston 11 and the inner ring piston 12, the automatic process of microneedle release and disinfectant release is realized, so that the automatic control of disinfection and drug delivery is realized, the disinfectant is released with a delay, the surgical field is prevented from being contaminated, and the whole treatment process is more smooth and convenient.

[0042] In the embodiment of the application, through the structure design that the device is provided with the double-layer structure of the central cavity 8 and the disinfectant cavity 14, and the outer ring piston 11 and the inner ring piston 12 are arranged in the central cavity 8 and the disinfectant cavity 14 respectively, the design of the double cavity and the double piston is realized, the automatic process of disinfection and drug delivery is realized, the whole treatment process is more smooth and convenient, the drug precision, patient comfort and operation convenience are comprehensively improved on the premise of ensuring pure mechanical operation, the defects that the existing device needs to use forceps for continuous clamping operation and excessively relies on the experience of operators are avoided, the drug is ensured to be accurately delivered to the target muscle layer, the risk of microneedle puncture penetrating the sclera is reduced, and the operation efficiency and treatment comfort are significantly improved.

[0043] Based on the above technical scheme, further, referring to the content shown in the accompanying drawings, the negative pressure suction assembly in the embodiment of the application comprises: a negative pressure pump 6; The communication pipe 5 is connected with the negative pressure pump 6 at one end and is communicated with the upper cavity below the movable plate 7 at the other end through the movable plate 7. Through the arrangement of the negative pressure suction assembly, in use, the inside of the handle 2 is subjected to negative pressure suction through the starting of the negative pressure pump 6, so that the connection of the microneedle assembly 1 and the suction head 13 can be controlled through the negative pressure effect of the negative pressure suction assembly, so that the operator can ensure the stable connection of the microneedle assembly 1 and the handle 2 during the injection of the extraocular muscle toxin of the patient, ensure that the microneedle does not deviate and loosen during the injection process, ensure the accurate positioning of the injection site, and realize the change range of the end face of the suction head from the convex surface to the concave surface through the negative pressure adjustment of the negative pressure assembly, so that the action range of the microneedle arrangement area on the microneedle assembly is reduced, and the needling area is concentrated, thereby avoiding the injury of the surrounding tissue of the eye.

[0044] Based on the above technical scheme, referring to the content shown in the accompanying drawings of the present application Figures 1-15 The microneedle assembly 1 in the embodiment of the present application comprises: The microneedle 101; The base 102; The air bag 103 is arranged on both sides of the base 102, and the position of the air bag 103 corresponds to the position of the suction hole 15. In use, the air bag 103 of the microneedle assembly 1 is butted against the end of the handle 2, that is, the end provided with the suction hole 15. When the negative pressure suction assembly performs negative pressure suction on the microneedle assembly 1, the air bag 103 passes through the suction hole 15 due to the negative pressure suction, and the air bag 103 is affected by the decrease of the surrounding air pressure to expand. After the expansion of the air bag 103, the air bag 103 is clamped in the suction hole 15, which connects the microneedle assembly 1 with the handle 1 on the one hand, and connects the microneedle assembly 1 with the suction hole 15 through the air bag 103 on the other hand, so as to prevent the accidental falling of the base 102 and ensure the stability of installation and the reliability of use.

[0045] Based on the above scheme, it needs to be supplemented that referring to the content shown in the accompanying drawings Figures 1-15 It needs to be explained that the end face of the suction head 13 in the present application is a convex surface. When the end of the handle 2 is subjected to the negative pressure effect, the convex surface of the end will become a concave surface due to the negative pressure suction effect, and at the same time, the concave surface of the closely attached base 102 will become a convex surface, so that the microneedles on the base 102 are more closely distributed towards the center, avoiding the injury of the surrounding tissue.

[0046] The base 102 in the embodiment of the present application can adopt medical silica gel with a diameter of 1.5 cm and a thickness of 0.5 mm. The end face of the base 102 and the suction head 13 can adopt a concave surface with a depth of 0.15 mm. The end face of the suction head 13 can be provided with a silica gel convex surface with a depth of 0.15 mm.

[0047] It should be noted that the microneedle 101 in the embodiment of the present application can be a hollow structure for loading the extraocular muscle botulinum toxin to be injected. The microneedle 101 in the embodiment of the present application can be designed as a pyramid (pyramid shape) with a base edge length of 50 μm and a height of 400 μm. The corner reinforced puncture guide is convenient for the microneedle to smoothly penetrate the conjunctival fascia layer to reach the muscle layer, while reducing the damage to the surrounding tissue. The base 102 is provided with four cylindrical air bags corresponding to the suction holes 15 on the end of the handle 1. The suction holes 15 can also be provided with a plurality of small holes. When the negative pressure suction is performed, the air in the small holes can be sucked to enhance the suction effect.

[0048] In some embodiments, the microneedle 101 adopts a dissolvable microneedle structure. The microneedle 101 and the base 102 can be detachably connected. Through the above design, the dissolvable microneedle 101 itself loads the drug. When the microneedle 101 is inserted into the skin, the base 102 and the microneedle 101 are separated and withdrawn. At this time, the microneedle 101 can gradually dissolve in the skin to release all the drugs to the target layer, so as to accurately release the drug and improve the drug utilization rate and treatment effect.

[0049] The extraocular muscle botulinum toxin precise regulation injection device of the present application is applied to the treatment scene of ophthalmic diseases. The specific use mode is as follows: First, taking the endo rectus muscle given botulinum toxin as an example, 1 drop of adrenaline is dropped into the conjunctival sac of the patient before using the extraocular muscle botulinum toxin precise regulation injection device of the present application, so that the blood vessels on the ocular surface are contracted under the action of adrenaline, and the ciliary blood vessels on the surface of the rectus muscle belly are still filled, which can highlight the position of the extraocular muscle, so as to help avoid key structures such as the preciliary blood vessels and reduce the operation risk. At this time, the microneedle can be placed at the corresponding position, i.e. the injection site of the extraocular muscle botulinum toxin. Then, when the device of the present application is used for injection operation, the suction head 13 is unscrewed to suck the disinfectant into the disinfectant cavity 10, and the push rod 4 drives the movable plate 7 to move in the handle 2 by rotating the adjusting knob 3, so as to adjust the initial volume of the upper chamber below the movable plate 7, so as to change the negative pressure suction force of the negative pressure suction assembly in the handle 2. Then, the microneedle assembly 1 is connected to the end face of the handle 2 provided with the suction head 13. One side of the microneedle 101 is placed away from one end of the suction hole 15. The air bag 103 is connected to the suction hole 15, the negative pressure suction assembly is started, the air bag 103 passes through the suction hole 15 due to the action of negative pressure suction and expands to be clamped in the suction hole 15, and at the same time, the end face of the suction head 13 changes from a convex surface to a concave surface due to the action of negative pressure. The base 102 is tightly attached to the end face of the suction head 13, so that the microneedles 101 on the base 102 are more closely distributed to the center, avoiding injury to the surrounding tissue. Thus, the connection between the microneedle assembly 1 and the handle 2 is completed. Finally, after adjustment, place the device of the application at the injection site of the extraocular muscle toxin, manually control the forward movement distance of the handle 2 (the size of the injection force), so as to limit the depth of the microneedle, after the injection is completed, the device is removed from around the eye, and then the pressure is released by adjusting the negative pressure assembly, so that the microneedle assembly 1 is separated from the suction head 13 and discarded, and when the microneedle assembly is separated, continue to release the pressure to push out the disinfectant in the disinfectant cavity 10 to disinfect the end of the suction head 13 for next use.

[0050] The precise control injection device for extraocular muscle toxin of the application comprises a microneedle assembly, a suction head, a handle and an injection control part, the suction head 13 is connected with the handle 2, and the microneedle assembly is tightly and stably connected with the end surface of the suction head 13 through the injection control part, on the premise of ensuring pure mechanical operation, the defects of the existing device, such as the need for continuous clamping operation of tweezers and excessive dependence on the experience of operators, can be avoided, the microneedle is ensured not to deviate and loosen during the injection process, the precise positioning of the injection site is ensured, the concentration of the drug action range is ensured to ensure that the drug is accurately delivered to the target muscle layer, the risk of penetrating the sclera is avoided, and the operation efficiency and treatment comfort are significantly improved.

[0051] Further, in the embodiment of the application, the end surface of the suction head 13 is a flexible convex structure, so that during the connection of the microneedle assembly 1 and the suction head 13, due to the adjustment of the injection control part, the end surface of the suction head changes from convex to concave, and the end surface of the microneedle assembly 1 connected with the suction head 13 also changes from convex to concave, so that the action range of the microneedle arrangement area on the microneedle assembly is reduced, and the needle puncture area is concentrated, so as to avoid injuring the tissues around the eye.

[0052] Further, in the embodiment of the application, the precise control injection device for extraocular muscle toxin can reduce the pain and psychological fear of patients during treatment and avoid the painful stimulation of traditional injection through the miniaturized needle body design of the microneedle assembly and the application of dissolvable materials.

[0053] Further, in the embodiment of the application, the precise control injection device for extraocular muscle toxin adopts a double-piston differential design and an adjustable negative pressure cavity, realizes the automatic process of disinfection and drug delivery, and makes the whole treatment process more smooth and convenient.

[0054] The above shows and describes the basic principles, main features and advantages of the present application. Those skilled in the art should understand that the present application is not limited to the above-mentioned embodiments, and the above-mentioned embodiments and descriptions in the specification are only preferred examples of the present application and are not intended to limit the present application. Various changes and improvements can be made to the present application without departing from the spirit and scope of the present application, and these changes and improvements all fall within the scope of the claimed present application. The scope of protection of the present application is defined by the appended claims and their equivalents.

Claims

1. An eye muscle botulinum toxin precision modulation injection device comprising a handle (2), characterized in that, Also comprising: a suction head (13) arranged at the end of the handle (2); a microneedle assembly (1) connected to the suction head (13); an injection control part arranged on the handle (2) for controlling the connection of the microneedle assembly (1) and the suction head (13).

2. The precise regulation injection device for extraocular muscle botulinum toxin of claim 1, wherein, The inside of the handle (2) is a hollow structure, which is divided into an upper cavity and a lower cavity, and the upper cavity and the lower cavity are separated by a partition plate. An inner sleeve (9) is arranged in the lower cavity, which divides the lower cavity into a disinfectant chamber (10) and a central chamber (8). The disinfectant chamber (10) and the central chamber (8) are respectively communicated with the upper cavity through air holes.

3. The precise regulation injection device for extraocular muscle botulinum toxin of claim 2, wherein, The end of the central chamber (8) is provided with a plurality of suction holes (15); The end of the disinfectant chamber (10) is provided with a disinfectant suction hole (14), and the disinfectant suction hole (14) is located on the surface of the suction head (13) and is distributed in an inner and outer ring with the suction hole (15).

4. The precise regulation injection device for extraocular muscle botulinum toxin of claim 3, wherein, The injection control part comprises: an outer ring piston (11) sleeved on the outer wall of the inner sleeve (9) and located in the disinfectant chamber (10); an inner ring piston (12) arranged on the inner wall of the inner sleeve (9) and located in the central chamber (8); an adjusting assembly arranged in the upper cavity of the handle (2) for adjusting the connection of the microneedle assembly (1) and the suction head (13).

5. The precise regulation injection device for extraocular muscle botulinum toxin of claim 3, wherein, The adjusting assembly comprises: a movable plate (7) arranged in the upper cavity, the top of which is provided with a push rod (4), and the end of the push rod (4) penetrates to the front end of the handle (2) and is connected with the adjusting knob (3); a negative pressure suction assembly communicated with the upper cavity below the movable plate (7) through a communication pipe (5).

6. The precise regulation injection device for extraocular muscle botulinum toxin of claim 4, wherein, The push rod (4) is screw-connected with the front end of the handle (2).

7. The precise regulation injection device for extraocular muscle botulinum toxin of claim 5, wherein, The microneedle assembly (1) comprises: a base (102) and a microneedle (101) and an air bag (103) arranged on both sides of the base (102).

8. The precise control injection device for extraocular muscle toxin according to claim 6, wherein The position of the air bag (103) corresponds to the position of the suction hole (15).

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