An ophthalmic microneedle

Abstract

This invention relates to an ophthalmic microneedle, comprising: a delivery assembly including a cannula mechanism, a closed head cap detachably mounted at one end of the cannula mechanism, and a tail tube detachably mounted at the other end of the cannula mechanism; the closed head cap has a fixed outer tube at its axial center; the cannula mechanism includes an outer shell with a movable limiting hole, a delivery block corresponding to the movable limiting hole and axially movable within the outer shell, and a needle unit mounted within the outer shell and extending into the fixed outer tube; the needle unit passes through the delivery block; the needle unit includes a metal needle tube, a polyimide needle tube fixed to the free end of the metal needle tube, and a connector fixed to the other end of the metal needle tube; and an external assembly. Utilizing the excellent flexibility of the polyimide needle tube, it can conform to the slight curvature of the ocular tissue during puncture, with minimal risk of breakage.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an ophthalmic microneedle. Background Technology

[0002] Diabetic retinopathy (DR) is one of the most common microvascular complications of diabetes. With the continued rise in the prevalence of diabetes, DR has become one of the leading causes of irreversible blindness in working-age individuals.

[0003] Currently, intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs is the preferred clinical treatment for retinal hemorrhage and neovascularization caused by diabetic retinopathy (DR). This method allows the drug to directly reach the lesion, resulting in a definite therapeutic effect. However, existing intravitreal injections all use rigid injection needles made of traditional stainless steel. In clinical practice, these rigid needles have the following shortcomings: First, the steel needle is hard and lacks flexibility. When the eyeball rotates slightly or the surgeon makes a slight deviation, the tip of the needle can easily come into rigid contact with delicate tissues such as the retina and lens capsule, posing a risk of puncture or scratching, or even needle breakage and residue in the eye, raising concerns about the safety of the procedure. Second, the existing steel needles have a relatively thick wall, which limits the minimum outer diameter of the needle. In applications requiring ultra-precise injections (such as retinal vascular puncture or injection in specific macular areas), it is difficult to meet the requirements of minimally invasive procedures. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the prior art and provide an ophthalmic microneedle.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is: an ophthalmic microneedle, comprising: The pushing component includes a sleeve mechanism, a closed head cap detachably mounted at one end of the sleeve mechanism, and a tail tube detachably mounted at the other end of the sleeve mechanism. The closed head sleeve has a fixed outer tube at its axial center. The sleeve mechanism includes an outer shell with a movable limiting hole, a push block that is axially movable within the outer shell and is corresponding to the movable limiting hole, and a needle unit installed within the outer shell and extending into the fixed outer tube. The needle unit passes through the push block and includes a metal needle tube, a polyimide needle tube fixed to the free end of the metal needle tube, and a connector fixed to the other end of the metal needle tube. An external component, one end of which is connected to the connector and the other end of which extends through the tail tube.

[0006] Ideally, the push block has a first group of connecting holes and a second group of connecting holes spaced apart on its circumferential surface. The sleeve mechanism further includes a push button installed in the first connecting hole group and extending to the outer shell via the movement limiting hole, and a screw installed in the second connecting hole group and connected to the metal needle tube. The outer casing is also provided with clearance holes corresponding to the screws.

[0007] Optimally, the closed headgear includes a cap body that is detachably installed at one end of the sleeve mechanism by means of threads and a damping block installed in the cap body, one end of the fixed outer tube is fixed in the cap body, and an anti-slip groove is formed on the circumferential surface of the cap body.

[0008] Furthermore, the tailpipe includes a tailpipe housing, a receiving cavity formed within the tailpipe housing, and a through hole formed within the tailpipe housing and communicating with the receiving cavity.

[0009] Furthermore, the external assembly includes a connecting hose, a first sleeve formed at one end of the connecting hose and cooperating with the connector, a second sleeve formed at the other end of the connecting hose, and an adapter connected to the second sleeve. The connecting hose extends through the through hole into the receiving cavity or the outer shell.

[0010] Furthermore, the first sleeve includes a flared portion connected to the connecting hose and a sleeve portion connected to the flared portion via a constricted portion.

[0011] Furthermore, the sleeve mechanism also includes anti-slip textures formed on the outer surface of the outer casing.

[0012] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: The ophthalmic microneedle of the present invention, through the cooperation of the push block and the moving limiting hole, can precisely control the axial movement of the needle unit, avoiding excessive pushing and causing damage to the ocular tissue; at the same time, the needle unit adopts a combination structure of a metal needle tube and a polyimide needle tube. Utilizing the excellent flexibility of the polyimide needle tube, it can conform to the slight curvature of the ocular tissue during puncture, virtually preventing breakage and avoiding the safety hazard of needle breakage and residue in the eye, significantly improving the safety of the operation and patient comfort. In addition, the external components and connectors can be used to connect to external injection devices to achieve continuous and stable drug delivery. The closed head, tail tube, and external components are all detachable, which facilitates independent replacement and cleaning and disinfection of each component, reducing the cost of use. At the same time, the anti-slip texture on the outer shell and the anti-slip groove on the closed head enhance the grip stability, while the damping block acts as a buffer when the needle extends and retracts, which helps to improve the user's feel. The overall structure is compact and highly operable, making it suitable for precise ocular drug delivery operations. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the structure of the ophthalmic microneedle of the present invention; Figure 2 This is a cross-sectional view of the ophthalmic microneedle of the present invention; Figure 3 for Figure 2 A magnified view of a portion of point A in the middle. Detailed Implementation

[0014] The preferred embodiments of the present invention will now be described in detail.

[0015] like Figure 1 and Figure 2 As shown, the ophthalmic microneedle of the present invention includes a matching push component 1 and an external component 2.

[0016] Pushing component 1 includes a sleeve mechanism 11, which is detachably (e.g., by conventional means such as threads) mounted on one end of the sleeve mechanism 11. Figure 1 The right end of the sleeve 12 and the other end of the sleeve mechanism 11 are detachably (e.g., by conventional means such as threads) the closed head sleeve 12 and the sleeve mechanism 11 are detachably (e.g., by conventional means such as threads) the other end of the sleeve mechanism 11. Figure 1 The tail tube 13 (left end of the middle).

[0017] A fixed outer tube 122 is fixedly installed at the axis of the closed head cap 12. One end of the fixed outer tube 122 is embedded and fixed inside the cap body 121 of the closed head cap 12 (the fixing method is welding or integral molding; the material of the fixed outer tube 122 is a metal material, such as stainless steel or titanium alloy, etc.), and the other end is an open end for the needle unit 118 to pass through. A damping block 124 is also provided inside the cap body 121 of the closed head cap 12 to provide buffering resistance when the needle unit 118 extends or retracts, so that the operator can get clear tactile feedback during the pushing and retraction process and avoid impact caused by inertia. Multiple anti-slip grooves 123 are evenly distributed on the outer circumference of the cap body 121, which can play an anti-slip role when installing the closed head cap 12, making it easy for the operator to tighten or loosen the closed head cap 12.

[0018] The sleeve mechanism 11 mainly includes a housing 111, a pusher block 114, and a needle unit 118. The side wall of the housing 111 has an axially extending movable limiting hole 113, and a clearance hole 112 spaced apart from the movable limiting hole 113. Anti-slip texture 117 is formed on the outer surface of the housing 111. The pusher block 114 is disposed inside the housing 111, and its outer peripheral surface is clearance-fitted with the inner wall of the housing 111. The pusher block 114 can move axially along the housing 111 under force. The peripheral surface of the pusher block 114 has a first connecting hole group (usually having two oppositely arranged first connecting holes) and a second connecting hole group (usually having two oppositely arranged second connecting holes) spaced apart.

[0019] A push button 115 is installed in the first connecting hole group and extends to the outside of the housing 111 via the movement limiting hole 113. By tossing the push button 115, the push block 114 can be driven to move axially back and forth along the guide direction of the movement limiting hole 113. (The push button 115 is installed in one of the first connecting holes, and a mating screw can be installed in the other first connecting hole. The push button 115 and the mating screw are arranged opposite to each other, and the two cooperate to clamp the metal needle tube 1181, the same below). Screws 116 are fixedly installed in the second connecting hole group (both second connecting holes are equipped with screws 116). The two screws 116 are used to clamp the metal needle tube 1181 of the needle unit 118. Thus, the push button 115 and the mating screw in the first connecting hole group work together to clamp the metal needle tube 1181, while the two screws 116 in the second connecting hole group further clamp and fix the metal needle tube 1181, forming a double clamping structure. When the push button 115 is turned to drive the push block 114 to move axially, it can synchronously drive the metal needle tube 1181 to move axially, ensuring that the needle unit 118 moves smoothly and accurately during the extension and retraction process, and avoiding needle deflection or slippage due to uneven clamping force.

[0020] The needle unit 118 passes through the push block 114 along the axial direction of the outer shell 111. One end of the needle unit 118 passes through the damping block 124 and enters the fixed outer tube 122. The other end of the needle unit 118 is connected to the external component 2 via a connector 1183. Specifically, the needle unit 118 includes a metal needle tube 1181, a polyimide needle tube 1182 fixed to one end of the metal needle tube 1181, and a connector 1183 formed at the other end of the metal needle tube 1181. Preferably, the outer diameter of the polyimide needle tube 1182 is adapted to the inner diameter of the metal needle tube 1181, and the two are fixed by conventional methods such as bonding or welding to ensure a reliable seal and no leakage at the connection. The outer diameter of the polyimide needle 1182 can be selected according to actual needs, such as 80~150 micrometers, and the wall thickness can be set to 10~15 micrometers. Within this size range, the needle can be guaranteed to have sufficient flexibility and fracture resistance, while providing a smooth channel for drug flow. The length of the metal needle 1181 is usually greater than the length of the outer shell 111, so that the polyimide needle 1182 can extend or retract from the front end of the fixed outer tube 122 under the action of the pusher block 114, realizing the controllable extension and safe retrieval of the needle tip. The connector 1183 is the tail end connector of the metal needle 1181. Its interior is connected to the lumen of the metal needle 1181, and its exterior is used to form a detachable sealed connection with the external assembly 2, so as to facilitate the introduction of drug and the independent replacement of the needle unit 118.

[0021] The tailpipe connector 13 includes a tailpipe housing 131, a receiving cavity 132 formed inside the tailpipe housing 131, and a through hole 133 formed inside the tailpipe housing 131 and communicating with the receiving cavity 132. The through hole 133 is arranged along the axial direction of the tailpipe housing 131 for the external component 2 to pass through. The diameter of the receiving cavity 132 is larger than the diameter of the through hole 133, and it is used to accommodate part of the external component 2.

[0022] External component 2 includes a connecting hose 21, a first sleeve 23, a second sleeve 22, and an adapter 24. The first sleeve 23 is formed at one end of the connecting hose 21 and includes a flared portion 231 connected to the connecting hose 21 and a connecting portion 233 (e.g., a constricted portion 232) connected to the flared portion 231. Figure 3 As shown, the flared portion 231 is fitted onto the outside of the connector 1183 and is limited by the constricted portion 232 and the sleeve portion 233. The second sleeve 22 is formed at the other end of the connecting hose 21 (its structure is basically the same as that of the first sleeve 23). The second sleeve 22 is connected to the adapter 24, which is used to connect an external syringe or injection pump. The connecting hose 21 extends through the through hole 133 into the receiving cavity 132 or the outer shell 111, and provides a certain redundant length to prevent the first sleeve 23 from detaching from the connector 1183 due to pulling during operation.

[0023] The general working principle of this ophthalmic microneedle is briefly described as follows: In use, the fixed outer tube 122 at the front end of the closed head cap 12 is first inserted into the sclera-fixed cannula; then, the push button 115 is pushed forward, and the push button 115 drives the push block 114 to slide forward along the movement limiting hole 113. The push block 114, through the double clamping structure formed by the mating screw in the first connecting hole group and the screw 116 in the second connecting hole group, synchronously drives the metal needle tube 1181 and the polyimide needle tube 1182 fixed at its front end to move forward, so that the polyimide needle tube 1182 extends out from the front end of the fixed outer tube 122, and continues to move the fixed tube 122 and the polyimide needle tube 1182 to the fundus, and the polyimide needle tube pierces the lesion site in the eye (at the moment of piercing the retina, the polyimide needle tube changes from a slightly deformed state to a straight state). At this point, an external syringe or infusion pump is connected via adapter 24. The medication is injected into the eye sequentially through connecting tubing 21, connector 1183, metal needle 1181, and polyimide needle 1182. Because the polyimide needle 1182 has excellent flexibility and breakage resistance, it bends under force without breaking during puncture and injection. The operator can sense changes in resistance when penetrating the retina, providing tactile feedback and preventing over-insertion. After injection, the push button 115 is pushed back, causing the push block 114 to retract the needle unit 118. The polyimide needle 1182 retracts into the fixed outer tube 122. During retraction, the damping block 124 provides buffering resistance to prevent inertial impact. Finally, the fixed outer tube 122 is withdrawn from the scleral puncture site, completing the injection operation.

[0024] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. An ophthalmic microneedle, characterized in that it include: Pushing component (1), the pushing component (1) includes a sleeve mechanism (11), a closed head sleeve (12) detachably installed at one end of the sleeve mechanism (11), and a tail tube (13) detachably installed at the other end of the sleeve mechanism (11). The closed head sleeve (12) has a fixed outer tube (122) at its axis. The sleeve mechanism (11) includes an outer shell (111) with a movable limiting hole (113), a push block (114) that is axially movable and corresponding to the movable limiting hole (113) and is disposed in the outer shell (111), and a needle unit (118) that is installed in the outer shell (111) and extends to penetrate the fixed outer tube (122). The needle unit (118) passes through the push block (114). The needle unit (118) includes a metal needle tube (1181), a polyimide needle tube (1182) fixed at the free end of the metal needle tube (1181), and a connector (1183) fixed at the other end of the metal needle tube (1181). An external component (2) is provided, one end of which is connected to the connector (1183) and the other end extends through the tail tube (13).

2. The ophthalmic microneedle according to claim 1, characterized in that: The push block (114) has a first connecting hole group and a second connecting hole group arranged at intervals on its peripheral surface. The sleeve mechanism (11) further includes a push button (115) installed in the first connecting hole group and extending to the outside of the outer shell (111) via the moving limiting hole (113), and a screw (116) installed in the second connecting hole group and connected to the metal needle tube (1181). The outer casing (111) is also provided with a clearance hole (112) corresponding to the screw (116).

3. The ophthalmic microneedle according to claim 1, characterized in that: The closed headgear (12) includes a cap body (121) that is detachably installed at one end of the sleeve mechanism (11) by threads and a damping block (124) installed in the cap body (121). One end of the fixed outer tube (122) is fixed in the cap body (121), and an anti-slip groove (123) is formed on the circumferential surface of the cap body (121).

4. The ophthalmic microneedle according to claim 1 or 3, characterized in that: The tail tube (13) includes a tail tube housing (131), a receiving cavity (132) opened in the tail tube housing (131), and a through hole (133) opened in the tail tube housing (131) and communicating with the receiving cavity (132).

5. The ophthalmic microneedle according to claim 4, characterized in that: The external assembly (2) includes a connecting hose (21), a first sleeve (23) formed at one end of the connecting hose (21) and cooperating with the connector (1183), a second sleeve (22) formed at the other end of the connecting hose (21), and an adapter (24) connected to the second sleeve (22). The connecting hose (21) extends through the through hole (133) into the receiving cavity (132) or the outer shell (111).

6. The ophthalmic microneedle according to claim 5, characterized in that: The first sleeve (23) includes a flared part (231) connected to the connecting hose (21) and a sleeve part (233) connected to the flared part (231) via a constricted part (232).

7. The ophthalmic microneedle according to claim 1 or 2, characterized in that: The sleeve mechanism (11) also includes anti-slip textures (117) formed on the outer surface of the outer casing (111).

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