Syringe sleeve, needle sleeve, injection assembly, and method of use thereof

Abstract

The present invention also provides a syringe sleeve including a positioning barrel (2) for fixing to a syringe barrel flange (41), and a connecting barrel (1) including a connecting end (12) and an injection end (11), where the connecting end (12) is used to connect to the positioning barrel (2), and the injection end (11) is used to position the portion of the tip of the needle (3) that is exposed from the connecting barrel (1). The provided syringe sleeve, needle sleeve, and injection assembly can conveniently position the portion of the tip of the needle (3) that is exposed from the connecting barrel (1), achieving quick and accurate adjustment of the syringe (4) while avoiding retraction of the syringe (4) and misalignment of the injection position.

Description

[Technical Field]

[0001] The present invention relates to the technical field of ophthalmic medical devices, and in particular to syringe sleeves, needle sleeves, injection assemblies, and methods of use thereof. [Background technology]

[0002] The eye is a highly complex visual organ, consisting of three parts: the eyeball, the visual pathway, and the adnexa. The eyeball and visual pathway complete the visual function. The eyeball, consisting of the ocular wall and ocular contents, is roughly spherical and highly complex in structure. The ocular wall is divided into three layers: the outer layer, the uvea, the middle layer, and the retina. The uvea is primarily composed of fibrous tissue and is the outer membrane of the eyeball. The uvea includes the cornea and sclera, of which the sclera accounts for 5 / 6 of the total. The sclera is composed of a tough, dense, intertwined structure. The thickness of the sclera varies across regions and individuals. The arrangement of scleral collagen fiber bundles differs in different parts of the eyeball at different developmental stages in children, adults, and the elderly. Because the eye is an exposed organ, it is susceptible to different types of damage, such as pathogenic damage to the conjunctiva and cornea. For example, the conjunctiva is a thin, transparent mucous membrane rich in blood vessels that covers the inner surface of the eyelid and the front of the eyeball, helping to prevent damage to the eyeball from foreign bodies and infection. However, the conjunctiva itself is highly sensitive and easily irritated by chemicals and allergens, or infected by viruses and bacteria, causing conjunctivitis. Its abundant blood vessels also allow many drugs (over 60%) to enter the systemic circulation, making it susceptible to unwanted tissue toxicity.

[0003] Currently, ocular fundus diseases are one of the leading causes of irreparable visual impairment or damage, including neovascular age-related macular degeneration, diabetic retinopathy, diabetic macular edema, central retinal vein occlusion, and branch retinal vein occlusion. In the treatment of ocular diseases, ocular drug delivery devices play a crucial role because tissue barriers (e.g., cornea, conjunctiva, blood-aqueous humor barrier, blood-retinal barrier, etc.) limit drug delivery to the fundus. While conventional delivery methods, such as ocular surface administration and intravitreal injection (IVT), are convenient, they often struggle to efficiently and safely deliver drugs to the affected area. Furthermore, ocular injections at incorrect locations or angles can lead to complications such as intraocular bleeding and retinal damage, resulting in cataracts and retinal detachment. Drug leakage can also lead to infection of other ocular tissues.

[0004] As mentioned above, due to the unique structure of the eye, drug delivery to the eye has always been a challenge. Delivery to the suprachoroidal space is particularly difficult due to the structure of the suprachoroidal space. The suprachoroidal space is a potential space between the sclera and the choroid, and no clear gap exists without fluid and / or tissue separation. When fluid or other materials accumulate between the choroid and the sclera, the suprachoroidal space can appear in that area. Therefore, by delivering, injecting, and / or injecting a drug formulation into the suprachoroidal space, fluid accumulation is intentionally created, further creating and / or expanding the suprachoroidal space formed by the separation of the choroid and the sclera. Administration to the suprachoroidal space can cause local choroidal hemorrhage during the injection process, which can cause retinal damage. In addition, complications such as endophthalmitis, scleral ectasia, and wound abscesses can occur during injection, and in rare cases, high intraocular pressure and cataracts can occur.

[0005] Injections into ocular tissue require high precision, including the distance between the syringe itself and the ocular tissue, the needle insertion distance, and the needle insertion position, and operators must accurately determine the position before injection. However, conventional injections into ocular tissue require repeated confirmation and measurement of the needle insertion distance and position before injection, which makes adjustments inconvenient to achieve the precision requirements when using a syringe, and operators often have to spend a lot of time and effort positioning the syringe in the eye. Meanwhile, to insert the needle into the eye, operators must apply a certain amount of force to the syringe and wear gloves, which can easily cause slippage between the syringe and the gloves. Furthermore, when the needle punctures the ocular tissue, it is difficult to position the syringe, and the needle may retract due to the influence of the ocular tissue or the injection position may shift, resulting in an incomplete injection and potentially causing an accident. Summary of the Invention [Problem to be solved by the invention]

[0006] An object of the embodiments of the present application is to provide a syringe sleeve, a sleeve with a needle, and an injection assembly that overcomes the drawback of conventional syringes, such as the inconvenience of adjusting injection accuracy, and realizes convenient adjustment of injection accuracy. Another object of the embodiments of the present application is to provide a syringe sleeve, a sleeve with a needle, and an injection assembly that allows the injection assembly to be quickly and accurately adjusted, eliminating the need to repeatedly measure and confirm the distance and position of the needle puncturing the ocular tissue during use, thereby saving a great deal of time and effort. Another object of the embodiments of the present application is to provide a syringe sleeve, a sleeve with a needle, and an injection assembly that allows the injection assembly to be positioned properly during injection into ocular tissue, provides a stable syringe position, and prevents needle retraction and deviation from the injection position. [Means for solving the problem]

[0007] To achieve the above object of the present application, the embodiments of the present application provide the following technical means.

[0008] A first aspect provides a syringe sleeve fitted onto the outside of a syringe, the syringe including a syringe barrel with a syringe barrel flange, the syringe sleeve, which may have a needle portion attached thereto, including a positioning barrel and a connecting barrel for fixing to the syringe barrel flange, the connecting barrel including a connecting end for connecting to the positioning barrel and an injection end for regulating the position of a portion of the tip of the needle portion exposed from the connecting barrel.

[0009] The syringe sleeve utilizes the structure of a conventional syringe, fixing the syringe barrel flange to the positioning barrel, assembling the syringe with the positioning barrel, and converting the operator's grip on the syringe into the operator's grip on the syringe sleeve, making it more convenient to use and operate. By positioning the syringe sleeve, the syringe can be positioned during injection into ocular tissue, thereby providing a stable syringe position and preventing the syringe from retracting and the injection position from shifting.

[0010] In a preferred embodiment of the present application, when the connecting tube and the positioning tube are connected, the overall length of the connecting tube and the positioning tube can be changed by the connection.

[0011] By connecting the connecting barrel and the positioning barrel, the overall length of the connecting barrel and the positioning barrel can be conveniently adjusted. The overall length of the connecting barrel and the positioning barrel can be changed at least once from the initial connection position and state to the final connection position and state, thereby realizing the change in the overall length of the connecting barrel and the positioning barrel. The injection end of the connecting barrel limits the relative position of the needle, but the tip of the needle can be exposed from the connecting barrel. By adjusting the relative position of the connecting barrel and the positioning barrel, the exposed length of the needle tip can be adjusted. Since the overall length of the connecting barrel and the positioning barrel in the final connection state is predetermined during manufacturing, the length of the syringe and the length of the needle are also predetermined during manufacturing. Thus, the exposed length of the needle tip can be determined by the parameters in advance. When the connecting barrel and the positioning barrel are connected in the final state, the exposed length of the needle tip becomes the needle tip length required for ocular injection, thereby realizing the positioning of the needle tip and meeting the requirements for injection into ocular tissue. Furthermore, the connection and adjustment of the syringe sleeve can be completed quickly, eliminating the need for repeated measurement and confirmation during use, saving a lot of time and effort.

[0012] In this specification, the term "position control" refers to fixing the part of the tip of the needle that is exposed from the injection end of the connecting tube, thereby preventing the exposed length of the tip of the needle from changing or the needle from shaking during the injection process.

[0013] In a preferred embodiment of the present application, the needle is equipped with a needle holder, and the injection end is provided with an annular boss on the inside thereof, which is used to lock the needle holder of the needle and regulate its position. The annular boss allows the injection end of the connecting barrel to limit the length of the needle extending from the connecting barrel and further limit the exposed length of the needle tip, thereby meeting injection requirements. The annular boss cooperates with the connecting barrel and the positioning barrel to quickly connect the syringe located in the positioning barrel to the needle holder of the needle, forming an integrated structure and locking the needle holder of the needle. This not only prevents the needle from retracting toward the syringe or shifting the injection position due to the influence of the injection site tissue during ocular injection, resulting in an inaccurate dose and affecting the injection effect, but also prevents the syringe from locking the needle holder when the operator applies thrust to the syringe pusher to move the pusher within the syringe, preventing the needle tip from moving excessively toward the target ocular tissue and damaging or penetrating it.

[0014] In a preferred embodiment of the present application, the needle holder of the needle portion has a convex rib around the top end thereof that engages with the annular boss to limit the length of the needle portion exposed from the injection end by the annular boss. By providing the convex rib that can be engaged with the annular boss, the needle holder can be conveniently engaged within the injection end of the connecting barrel.

[0015] In a preferred embodiment of the present application, the end of the injection tip is provided with a clamping port for pressing against the ocular tissue at the injection site. The clamping port has an annular end surface, and the minimum inner diameter of the annular end surface is 1 mm to 3 mm. During use, the needle is inserted into the injection point to inject. The minimum inner diameter of the annular end surface of the clamping port refers to the length of the shortest line segment that passes through the injection point and has both ends located inside the clamping port, with the injection point located at the center of this line segment. Experimental results have shown that when the minimum inner diameter is 1 to 3 mm, the area of ​​the ocular tissue within the clamping port is appropriate, and the ocular tissue within the clamping port can form a clear protrusion, making the injection procedure easier. The clamping port facilitates contact with the ocular tissue and fixation of the syringe position, improving the success rate of injection and ensuring smooth delivery of the drug solution to the target site.

[0016] In a preferred embodiment of the present application, the injection end is further provided with a chamber, one end of which is closed by the needle holder of the needle part, and the other end of which is closed by the clamping port pressing against the ocular tissue. By providing the chamber, if reflux occurs, the refluxed medicinal solution is contained in the sealed chamber, and when the clamping port is separated from the ocular tissue, the medicinal solution is less likely to leak from the sealed chamber, preventing the medicinal solution from dripping onto the ocular tissue.

[0017] In a preferred embodiment of the present application, the side wall of the injection tip is provided with a viewing window made of a transparent material, or the injection tip is made of a transparent material. By providing a viewing window or forming a transparent material, the backflow of the medicinal liquid can be easily observed and the success of the injection can be quickly determined.

[0018] In a preferred embodiment of the present application, the connecting end and the positioning tube can be connected by a screw connection or a snap-fit ​​connection, which not only enables the connection between the connecting tube and the positioning tube to be realized by the screw connection or the snap-fit ​​connection, but also allows the total length to be adjusted at least once or continuously from the initial connection state or the incomplete connection state to the final connection state between the connecting tube and the positioning tube, so that the total length between the connecting tube and the positioning tube can be adjusted to a desired value, thereby fine-tuning the exposed length of the needle tip according to the sclera thickness of different patients to meet the injection needs.

[0019] In a preferred embodiment of the present application, the connecting end of the connecting barrel is connected to the end of the positioning barrel facing the needle, or the connecting barrel is placed on the positioning barrel and connected to the end of the positioning barrel facing the tail of the syringe pusher. By providing two connection methods, different connection methods and different usage processes for the connecting barrel and the positioning barrel can be provided, thereby expanding the application range of the syringe sleeve.

[0020] In a preferred embodiment of the present application, the connecting end is provided with a male thread and the positioning tube is provided with a female thread, and the connecting end is connected to the positioning tube by rotation, and the total length of the connecting tube and the positioning tube can be adjusted by rotating. By setting the screw connection method, the relative lengths of the connecting tube and the positioning tube can be adjusted, thereby realizing the adjustment of the total length.

[0021] In a preferred embodiment of the present application, the connecting barrel is placed and connected within the positioning barrel from one end of the positioning barrel facing the tail of the syringe pusher. After the syringe is attached, the syringe barrel flange abuts against the connecting end, limiting the rotational retraction distance of the connecting end within the positioning barrel. By engaging the syringe barrel flange with the positioning barrel, the syringe can be integrally combined with the positioning barrel, and the position of the connecting end of the connecting barrel within the positioning barrel can be adjusted. The final retraction position of the connecting end is the position where the end of the connecting end abuts against the syringe barrel flange, preventing the connecting end from retracting any further, thereby realizing the function of preventing the syringe sleeve from retracting.

[0022] In a preferred embodiment of the present application, the inner wall of the connecting barrel is provided with a single-stage engaging groove for engaging with the outside of the syringe barrel or the outside of the needle holder of the needle along the axial direction of the connecting barrel, and the syringe can move along the axial direction of the connecting barrel under the guidance of the engaging groove. The engaging groove allows the connecting barrel to provide at least one axial channel, which can accommodate the outside of the syringe barrel or the outside of the needle holder of the needle, thereby guiding the syringe to move only along the central axial direction within the connecting barrel, preventing the needle from contacting the inner wall of the connecting barrel during the movement process and helping to keep the needle clean.

[0023] In a preferred embodiment of the present application, the needle holder of the needle is provided with a protrusion, the shape and size of which match the cross section of the locking groove. By matching the protrusion structure on the outside of the needle holder with the locking groove, the needle can move axially within the connecting barrel according to the locking groove when the syringe is placed, and the syringe can always move in one direction under the guidance of the needle without shaking, avoiding contact between the needle and the inner wall of the connecting barrel during the process of placing the syringe.

[0024] In a preferred embodiment of the present application, the positioning barrel is provided with a mounting groove for mounting the syringe barrel flange, and the syringe barrel flange is rotated to engage with the mounting groove, which facilitates the engagement of the syringe barrel flange with the positioning barrel to securely connect the syringe barrel and the positioning barrel.

[0025] In a preferred embodiment of the present application, the positioning barrel is provided with a flange mount and a lock tag, the flange mount is used to support one side of the syringe barrel flange, and the lock tag is used to lock the other side of the syringe barrel flange, and the gap between the lock tag and the flange mount forms a mounting groove. The flange mount and lock tag provide a space in the positioning barrel where the syringe barrel flange can be locked, making it easy to fix the syringe and the positioning barrel.

[0026] In a preferred embodiment of the present application, an arc-shaped protrusion structure is provided on the top of the flange mount or the bottom of the locking tag, which is used to lock one side of the syringe barrel flange. By providing the arc-shaped protrusion structure, when the syringe barrel flange is rotated into the mounting groove, the flange mount or the locking tag is firmly pressed against the surface of the syringe barrel flange, locking the syringe barrel into the mounting groove. Once inserted, the locked state is maintained, preventing the syringe from being dislodged from the positioning barrel.

[0027] In a preferred embodiment of the present application, the positioning tube further includes a positioning structure on the outside for securing the operator's fingers, the positioning structure being a protrusion, notch, or ring structure. Ophthalmic syringes generally have an outer diameter of several millimeters, requiring operators to wear gloves to handle the syringe directly. Rubber gloves are inconvenient for handling syringe sleeves, often resulting in an unstable grip or slipping off. The positioning structure facilitates finger positioning, making it easier for operators to conveniently hold and handle the syringe sleeve.

[0028] In a preferred embodiment of the present application, the needle portion has a plurality of sizes, and the needle hubs of the different sizes have different lengths, which may be 5 to 10 mm. By setting the needle hub length, different sizes of needle portions are provided, making it easy for the operator to select a different size of needle portion according to the different conditions and needs of each patient.

[0029] In a preferred embodiment of the present application, the injection end is provided with a contraction section, which is used to lock the needle holder of the needle and position the needle. The internal opening of the contraction section is relatively small, and the injection end can lock the top end of the needle holder of the needle, restricting further movement of the needle holder and realizing the function of restricting the position of the needle. Furthermore, the injection end can pass through the needle hub of the needle, so that the tip of the needle can be exposed at the injection end of the connecting barrel after connecting the connecting barrel and the positioning barrel. The syringe sleeve replaces the operator's grip on the syringe with the operator's grip on the syringe sleeve, making use and operation more convenient. By connecting the connecting barrel and the positioning barrel, the overall length of the connecting barrel and the positioning barrel can be easily adjusted, and by adjusting the relative positions of the connecting barrel and the positioning barrel, the exposed length of the tip of the needle can be adjusted and the position of the tip of the needle can be controlled, so that the exposed length of the tip of the needle can be precisely adjusted to meet the requirements of injection into ocular tissue.

[0030] When the connecting tube and the positioning tube adjust the exposed length of the needle tip and regulate the position of the needle, the syringe located inside the positioning tube can be quickly connected to the needle holder of the needle to form an integrated structure and lock the needle holder of the needle. This not only prevents the needle from retracting toward the syringe or shifting the injection position due to the influence of the injection site tissue during eye injection, which could result in an inaccurate dose and affect the injection effect, but also prevents the syringe from locking the needle holder of the needle when the operator applies thrust to the syringe pusher to move the pusher within the syringe, which prevents the needle tip from moving with the movement of the pusher and excessively extending into the target eye tissue, thereby preventing it from damaging or penetrating the target eye tissue.

[0031] In a preferred embodiment of the present application, the syringe sleeve is configured to couple the positioning tube and the connecting tube, thereby locking the needle on the syringe, thereby preventing the needle from retracting toward the syringe or shifting the injection position due to the influence of the injection site tissue during injection into the eye, resulting in an inaccurate dose and affecting the injection effect.

[0032] In a preferred embodiment of the present application, the syringe sleeve is configured such that the positioning barrel and the connecting barrel are coupled together to prevent the tip of the needle from moving in accordance with the movement of the pusher and from excessively extending into the target tissue of the eye, thereby preventing damage or penetration of the target tissue of the eye.

[0033] A second aspect provides a sleeve with a needle that is fitted onto the outside of a syringe, the syringe including a syringe barrel with a syringe barrel flange, the needle having a needle holder, the sleeve with needle including a positioning barrel for fixing to the syringe barrel flange, a connecting barrel, and an injection end, the connecting barrel including a connecting end for connecting to the positioning barrel, the injection end being connected to the needle holder within it and used to limit the length of the tip of the needle that is exposed from the injection end of the connecting barrel.

[0034] In a preferred embodiment of the present application, when the injection tip and the needle holder are connected, the overall length of the injection tip and the needle holder can be changed by the connection.

[0035] The syringe sleeve directly connects the needle to the connecting barrel, and the injection end limits the exposed length of the needle tip. In this way, the length of the injection end of the connecting barrel and the length of the needle are predetermined during manufacturing, so the exposed length of the needle tip when the connecting barrel and the needle are finally connected can be determined in advance based on manufacturing parameters. The exposed length of the needle tip when the connecting barrel and the needle are finally connected is the needle tip length required for ocular injection, thereby realizing the positioning of the needle tip and meeting the requirements for ocular tissue injection. The needle sleeve can be quickly connected and adjusted to the desired position, eliminating the need for repeated measurement and confirmation during use, saving a lot of time and effort.

[0036] When the connecting tube and the positioning tube adjust the exposed length of the needle tip and regulate the position of the needle, the syringe located inside the positioning tube can be quickly connected to the needle holder of the needle to form an integrated structure and lock the needle holder of the needle. This not only prevents the needle from retracting toward the syringe or shifting the injection position due to the influence of the injection site tissue during eye injection, resulting in an inaccurate dose and affecting the injection effect, but also prevents the syringe from locking the needle holder of the needle when the operator applies thrust to the syringe pusher to move the pusher within the syringe, preventing the needle tip from moving with the movement of the pusher and excessively extending into the target eye tissue, preventing it from damaging or penetrating the target eye tissue.

[0037] A third aspect provides an injection assembly including the above-mentioned syringe sleeve or the above-mentioned needle-equipped sleeve, and a syringe, the syringe being housed in a connecting barrel and a positioning barrel, the syringe barrel flange of the syringe engaged with a mounting groove, and the length of the syringe needle exposed from the connecting barrel being adjustable by connecting the connecting barrel to the positioning barrel or connecting the connecting barrel to the needle holder of the needle. This injection assembly can be combined with a conventional syringe and not only allows the length of the needle tip for injection into eye tissue to be conveniently adjusted to the required length and accuracy, but also helps the operator to operate with one hand, making use and operation more convenient. Furthermore, once the connecting barrel and the positioning barrel adjust and position the exposed length of the needle tip, the syringe located in the positioning barrel can be quickly connected to the needle holder of the needle, forming an integrated structure that locks the needle holder of the needle.

[0038] A fourth aspect provides a method for using the syringe sleeve described above or the syringe sleeve with a needle, which includes first connecting the connecting barrel and the positioning barrel, then placing the syringe barrel into the connecting barrel and the positioning barrel, and then inserting and fixing the syringe barrel flange into the mounting groove. Alternatively, it may include first fitting the positioning barrel onto the outside of the syringe barrel, then inserting and fixing the syringe barrel flange into the mounting groove, and then connecting the connecting barrel and the positioning barrel. This method not only secures the positioning barrel and the syringe together, but also forms a sleeve on the outside of the syringe, providing an integrated structure for assembling the syringe and the sleeve. This not only facilitates operator operation and use, but also allows the syringe to lock the needle holder of the needle, preventing the needle from retracting toward the syringe or shifting the injection position due to the influence of tissue at the injection site during ocular injection, resulting in an inaccurate dose and adversely affecting the injection effect.

[0039] When the operator applies thrust to the syringe pusher to move the pusher within the syringe, the syringe locks the needle holder of the needle, and the sleeve of the present invention also prevents the tip of the needle from moving with the movement of the pusher, thereby preventing it from extending further into the target tissue of the eye and causing excessive damage or penetration of the target tissue of the eye.

[0040] In a preferred embodiment of the present application, the connection between the connecting barrel and the positioning barrel allows the overall length of the connecting barrel and the positioning barrel to be adjusted, or the connection between the connecting barrel and the needle holder of the needle part allows the overall length of the connecting barrel and the needle holder of the needle part to be adjusted, thereby further adjusting the relative length of the needle tip exposed from the injection end of the connecting barrel. The connection between the connecting barrel and the positioning barrel forms an integrated structure after assembly, and the connection between the connecting barrel and the positioning barrel allows the overall length of the integrated structure to be adjusted, and further allows the exposed length of the needle tip to be adjusted.

[0041] In a preferred embodiment of the present application, after the syringe barrel flange is moved to a corresponding position in the mounting groove during use, the syringe barrel flange is rotated along with the connecting barrel or manually rotated to rotate the syringe barrel flange into the mounting groove, and after the engagement, the syringe barrel and the positioning barrel are locked together. The syringe rotation engagement method allows the syringe barrel to be quickly and conveniently connected and fixed to the positioning barrel, achieving one-time engagement and locking.

[0042] A fifth aspect provides a method for using the above-described injection assembly, which includes selecting a syringe with a different needle specification according to needs, then fixing the syringe to the positioning barrel, and adjusting the length of the needle tip exposed from the connecting barrel by adjusting the overall connection length between the connecting barrel and the positioning barrel or the overall length between the connecting barrel and the needle holder of the needle. By selecting a syringe with a different needle specification, the needs of people of different ages and the actual eye tissue thickness parameters of different patients can be met.

[0043] A sixth aspect provides a method for using the above-mentioned injection assembly, including: selecting a needle of a different specification according to needs, placing it in the connecting barrel, and adjusting the overall connection length between the connecting barrel and the positioning barrel or the overall length between the connecting barrel and the needle holder of the needle, thereby moving the needle to the injection end of the connecting barrel and adjusting the length of the needle's tip exposed from the connecting barrel. The operator can quickly select a needle of a different specification according to the thickness of the patient's sclera, and the sleeve described herein can fine-tune the exposed length of the needle's tip according to needs, making it easy for the operator to quickly select and safely assemble the syringe. It can also meet the different needs of people of different ages and the different thickness parameters of different patients' actual ocular tissues, thereby improving the success rate of injection.

[0044] In a preferred embodiment of the present application, when the connecting tube is threadedly connected to the positioning tube from the end of the positioning tube facing the tail of the syringe pusher, the connecting tube is rotated in the forward direction during connection, and the length of the needle tip exposed from the connecting tube can be adjusted by rotating the connecting tube in the reverse direction. By changing the rotation method of the connecting tube, the connection between the connecting tube and the positioning tube is divided into two stages: the first is a rotational connection, which realizes the connection between the connecting tube and the positioning tube; and the second is a reverse rotation, which realizes the adjustment of the overall length of the connecting tube and the positioning tube, and also adjusts the exposed length of the needle tip.

[0045] In a preferred embodiment of the present application, the exposed length of the tip of the needle portion is 500 to 2000 microns, preferably 700 to 1350 microns, and more preferably 700 to 1100 microns.

[0046] In a preferred embodiment of the present application, the length of the cutting edge of the tip of the needle is 1100 microns or less, preferably 900 microns or less, further preferably 700 microns or less, even more preferably 550 microns or less, and most preferably 250 to 550 microns.

[0047] In a preferred embodiment of the present application, the above-mentioned method of use further includes locking a finger with the position restriction structure, holding the syringe sleeve with the same hand, contacting and pressing the clamping port against the ocular tissue at the injection site so that the ocular tissue at the injection site protrudes into the connecting barrel, then causing the tip of the needle to puncture the ocular tissue at the injection site and reach the target ocular tissue, and operating the syringe pusher to push the medication into the target tissue. The position restriction structure allows the finger to be fixed on the outside of the sleeve, making it easy to fix the fingers of one hand to the sleeve, and the clamping port allows the tip of the needle to contact and press against the ocular tissue so that it can precisely puncture and reach the target ocular tissue, making it easy for the operator to inject medication into the ocular tissue with one hand.

[0048] The syringe sleeve, needle sleeve, injection assembly, and methods of use provided in the present application are applicable to a wide range of ophthalmic diseases and related conditions, including, but not limited to, uveitis, glaucoma, diabetic macular edema, retinopathy, macular degeneration, retinoblastoma, and genetic disorders.

[0049] In the present application, any device or method can be used to treat ocular diseases by inserting the effective length of a needle into a patient's scleral tissue and delivering a drug to the suprachoroidal space through the inserted needle. In some embodiments, the effective amount of drug administered to the suprachoroidal space provides a higher therapeutic effect than the therapeutic effect of the drug when the same dose is administered intravitreally, topically, intracamerally, parenterally, or orally. Any device or method provided in the present application precisely delivers a drug to the suprachoroidal space for subsequent local delivery to nearby posterior ocular tissues (e.g., the retina and choroid) that require treatment. The drug is continuously released into the ocular tissue for a period of time, such as several hours, days, weeks, or months, after administration is complete. In some embodiments, any device or method provided in the present application can improve the bioavailability of the drug by local administration to ocular tissues compared to administering the same dose of drug orally, parenterally, or intravitreally.

[0050] The syringe sleeve, needle sleeve, injection assembly, and methods of use provided in the examples of the present application are particularly suitable for delivering drugs to localized regions at the back of the eye, such as the retina-choroidal tissue, macula, and optic nerve at the back of the eye. The syringe sleeve, needle sleeve, injection assembly, and methods of use provided in the examples of the present application deliver medicinal solutions, including gene-based therapies and gene fragment therapies, to the suprachoroidal space, and deliver one or more vectors selected from DNA, RNA, or oligonucleotides to target tissues of the eye.

[0051] As used herein, the term "drug" refers to any prophylactic, therapeutic, or diagnostic agent (e.g., an imaging agent). The drug may be selected from any suitable protein, peptide, or fragment thereof, and may be naturally occurring, synthetic, or recombinantly produced.

[0052] In some embodiments of the present application, the syringe contains a drug solution of one or more pharmaceutically active agents, which may be selected from antibodies, antivirals, chemotherapeutic agents, analgesics, anesthetics, aptamers, antihistamines, anti-inflammatory agents, and anti-tumor agents.

[0053] As used herein, the term "antibody" refers broadly to any immunobinding agent, e.g., IgG, IgM, IgA, IgD, and IgE. Antibodies may be monoclonal or polyclonal, and in some examples are humanized antibodies. The term "antibody" also refers to any antibody-like molecule that comprises an antigen-binding region and includes antibody fragments, e.g., Fab", Fab, F(ab")2, single domain antibodies (DAB), Fv, scFv (single-chain Fv), and engineered multivalent antibody fragments such as bivalent, trivalent, and multivalent antibodies. Techniques for making and using antibodies and different constructs and fragments based thereon are well known in the art.

[0054] In some embodiments, the syringe contains one or more recombinant adeno-associated virus (rAAV)-vectored gene therapy drugs, where the AAV is selected from AAV1, AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, AAV9, AAV10, or variants thereof. Preferably, the AAV is AAV8 or a variant thereof. Preferably, the rAAV contains a drug expressed for the treatment of an ocular disease, such as an anti-VEGF drug, a complement factor inhibitor (complement component C3, complement factor B, complement factor D), a plasma kallikrein inhibitor, a PDGFR inhibitor, a tyrosine kinase inhibitor, an integrin inhibitor, an angiopoietin-2 inhibitor, and a Tie-2 agonist.

[0055] In some embodiments of the present application, the syringe is a prefilled syringe, which prevents the operator from causing damage to himself or herself or causing an inaccurate drug dose during the dispensing process, and not only reduces the probability of drug use errors, but also effectively reduces residual drug solution, makes the drug dose more accurate, and prevents cross-contamination because air does not come into contact with the drug.

[0056] A seventh aspect provides a kit, comprising: a vial containing a drug solution; and an injection assembly, the injection assembly employing the syringe sleeve or the sleeve with a needle as described above; a syringe disposed within a connecting barrel and a positioning barrel; a syringe barrel flange of the syringe engaged with a mounting groove; and a length of the syringe needle exposed from the connecting barrel being adjusted by connecting the connecting barrel to the positioning barrel or connecting the connecting barrel to the needle holder of the needle; the injection assembly can be combined with a conventional syringe, and not only can the length of the needle tip for injection into ocular tissue be conveniently adjusted to the required length and accuracy, but also helps operators to operate with one hand, making use and operation more convenient; and once the connecting barrel and the positioning barrel have adjusted the exposed length of the needle tip and restricted its position, the syringe located within the positioning barrel can be quickly connected to the needle holder of the needle to form an integrated structure, and the needle holder of the needle can be locked.

[0057] In some embodiments of the present application, the pharmaceutical solution comprises a pharmaceutical solution of one or more pharmaceutical active agents, which may be selected from antibodies, antivirals, chemotherapeutic agents, analgesics, anesthetics, aptamers, antihistamines, anti-inflammatory agents, and anti-tumor agents.

[0058] In some embodiments, the vial contains one or more recombinant adeno-associated virus (rAAV)-vectored gene therapy drugs, where the AAV is selected from AAV1, AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, AAV9, AAV10, or variants thereof. Preferably, the AAV is AAV8 or a variant thereof. Preferably, the rAAV contains a drug expressed for the treatment of an ocular disease, such as an anti-VEGF drug, a complement factor inhibitor (complement component C3, complement factor B, complement factor D), a plasma kallikrein inhibitor, a PDGFR inhibitor, a tyrosine kinase inhibitor, an integrin inhibitor, an angiopoietin-2 inhibitor, and a Tie-2 agonist.

[0059] An eighth aspect provides a kit, including a prefilled syringe assembly, the prefilled syringe assembly using the syringe sleeve described above or the sleeve with a needle described above and a prefilled syringe, the prefilled syringe being placed in a connecting barrel and a positioning barrel, the syringe barrel flange of the prefilled syringe being engaged with a mounting groove, the length of the needle of the prefilled syringe exposed from the connecting barrel being adjusted by connecting the connecting barrel with the positioning barrel or connecting the connecting barrel with the needle holder of the needle, the prefilled syringe assembly can be combined with a conventional prefilled syringe, and not only can the length of the tip of the needle for injection into eye tissue be conveniently adjusted to the required length and accuracy, but also helps the operator to work with one hand, making it more convenient to use and operate, and when the connecting barrel and the positioning barrel adjust the exposed length of the tip of the needle and regulate its position, the prefilled syringe located in the positioning barrel can be quickly connected to the needle holder of the needle to form an integrated structure, and the needle holder of the needle can be locked.

[0060] In some embodiments of the present application, the prefilled syringe is prefilled with a drug solution of one or more pharmaceutically active substances, which can be selected from antibodies, antivirals, chemotherapeutic agents, analgesics, anesthetics, aptamers, antihistamines, anti-inflammatory agents, and anti-tumor agents.

[0061] In some embodiments of the present application, the prefilled syringe of the present invention is prefilled with one or more recombinant adeno-associated virus (rAAV)-vectored gene therapy drugs, where the AAV is selected from AAV1, AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, AAV9, AAV10, or variants thereof. Preferably, the AAV is AAV8 or a variant thereof. Preferably, the rAAV contains a drug expressed for the treatment of ocular diseases, such as an anti-VEGF drug, a complement factor inhibitor (complement component C3, complement factor B, complement factor D), a plasma kallikrein inhibitor, a PDGFR inhibitor, a tyrosine kinase inhibitor, an integrin inhibitor, an angiopoietin-2 inhibitor, and a Tie-2 agonist.

[0062] Drug solution filling techniques for the prefilled syringes of the present invention are well known in the art. [Effects of the Invention]

[0063] Compared with the prior art, the embodiments of the present application achieve the following beneficial effects:

[0064] 1. The syringe sleeve / needle sleeve provided in the embodiments of this application utilizes the structure of a conventional syringe, combining the syringe with the sleeve and converting the operator's grip on the syringe into the syringe sleeve, making use and operation more convenient. Positioning the syringe sleeve enables the syringe to be positioned during injection into ocular tissue, thereby providing a stable syringe position and preventing the syringe from retracting and shifting in injection position. Furthermore, the inner annular boss on the injection end of the connecting barrel and the convex rib around the top end of the needle holder of the needle adjust the length of the needle tip exposed from the injection end of the connecting barrel, thereby enabling the needle tip to be positioned to meet the requirements for injection into ocular tissue. Connection and adjustment can be quickly achieved, and the syringe locks the needle holder of the needle, eliminating the need for repeated measurement and confirmation during use, saving significant time and effort. Furthermore, it also prevents the needle from retracting toward the syringe or shifting in injection position due to the influence of tissue at the injection site during ocular injection, resulting in an inaccurate dose and affecting the injection effect.

[0065] 2. The syringe sleeve provided in the embodiments of the present application is connected to the positioning tube or the needle holder of the needle part by the connecting end of the connecting tube, and the exposed length of the needle tip can be adjusted by adjusting the overall length between the connecting tube and the positioning tube or the overall length between the connecting tube and the needle holder of the needle part.

[0066] 3. The syringe sleeve provided in the embodiments of the present application makes it easy to position the fingers, allowing the operator to conveniently hold the syringe sleeve in their hand, fix the fingers and the syringe sleeve relative to each other, and facilitate operation.

[0067] 4. The syringe sleeve provided in the embodiments of the present application allows the syringe to be integrally assembled with the positioning barrel by engaging the syringe barrel flange with the positioning barrel, and the position of the connecting end of the connecting barrel within the positioning barrel can be adjusted. The final retraction position of the connecting end is where the end of the connecting end abuts the syringe barrel flange, at which point the connecting end will not retract any further, thereby realizing the anti-retraction function of the syringe sleeve.

[0068] 5. The injection assembly provided in the embodiments of this application combines a sleeve with a conventional syringe and can be adapted to different usage needs by selecting different specifications of needle length. In addition, the connection structure of the sleeve itself allows the exposed length of the needle tip to be adjusted. When the sleeve is adjusted to the correct position, the exposed length of the needle tip reaches the required length and accuracy, thereby realizing the requirements for ocular injection. Furthermore, the injection assembly helps the operator to operate with one hand, making it more convenient to use and operate.

[0069] 6. The syringe sleeve use method provided in the embodiments of the present application can achieve mutual fixation between the positioning barrel and the syringe, and form the sleeve on the outside of the syringe, providing an integrated structure for combining the syringe and the sleeve, which is convenient for operators to operate and use.

[0070] 7. The method of using the injection assembly provided in the embodiments of this application can meet the needs of people of different ages and the actual thickness parameters of different patients' ocular tissues by selecting different specifications of needle syringes, and can also adjust the exposed length of the needle tip by adjusting the total length between the connecting barrel and the positioning barrel, or the total length between the connecting barrel and the needle holder of the needle, which helps the needle reach the desired position of the ocular tissue, ensures the injection effect, and improves the success rate of injection.

[0071] 8. The injection assembly provided in the embodiments of the present application combines a sleeve with a conventional syringe, so that when the eye is punctured, the tip of the needle does not retract or swing back toward the syringe, causing the injection position to shift. Even when thrust is applied to the syringe pusher to move it within the syringe, the tip of the needle does not move, preventing the tip of the needle from excessively extending within the target tissue of the eye and damaging or penetrating the target tissue. [Brief explanation of the drawings]

[0072] In order to more clearly explain the embodiments of the present invention and the technical means of the prior art, the following briefly introduces the drawings necessary for use in the embodiments and the prior art. Obviously, the drawings described below are only some embodiments of the present invention. Those skilled in the art can obtain other drawings based on these drawings without paying creative work.

[0073] [Figure 1] 1 is an exploded schematic view of a syringe sleeve according to Example 1 of the present application. FIG. [Figure 2] 1 is a schematic diagram of a needle portion used in a syringe sleeve according to Example 1 of the present application. [Figure 3] 1 is a schematic cross-sectional view of the injection end of a syringe sleeve according to Example 1 of the present application, showing the tip of the needle portion. [Figure 4] 3A to 3C are schematic diagrams of annular end surfaces of different shapes in different examples of a syringe sleeve according to Example 1 of the present application. [Figure 5] 3A to 3C are schematic diagrams of annular end surfaces of different shapes in different examples of a syringe sleeve according to Example 1 of the present application. [Figure 6] 3A to 3C are schematic diagrams of annular end surfaces of different shapes in different examples of a syringe sleeve according to Example 1 of the present application. [Figure 7] 1 is a schematic diagram of a protrusion formed by a syringe sleeve and eye tissue according to Example 1 of the present application, and a drug being injected and administered. [Figure 8] 1A and 1B are schematic diagrams of needles of different gauges used in a syringe sleeve according to Example 1 of the present application. [Figure 9] FIG. 10 is a schematic diagram of a syringe sleeve connection according to Example 2 of the present application. [Figure 10] FIG. 10 is a schematic view of a positioning cylinder of a syringe sleeve according to a second embodiment of the present invention. [Figure 11] FIG. 10 is a schematic diagram of the use of a syringe sleeve according to Example 2 of the present application. [Figure 12] FIG. 1 is a schematic diagram of a syringe used in the examples of the present application. [Figure 13] 10A to 10C are schematic diagrams of position restriction structures of different shapes employed in different examples of a syringe sleeve according to Example 2 of the present application. [Figure 14] 10A to 10C are schematic diagrams of position restriction structures of different shapes employed in different examples of a syringe sleeve according to Example 2 of the present application. [Figure 15] 10A to 10C are schematic diagrams of position restriction structures of different shapes employed in different examples of a syringe sleeve according to Example 2 of the present application. [Figure 16] FIG. 10 is a schematic cross-sectional view of a connecting barrel of a syringe sleeve according to a second embodiment of the present invention. [Figure 17] FIG. 10 is a partial cross-sectional schematic view of a syringe sleeve according to a second embodiment of the present invention. [Figure 18] FIG. 10 is a schematic diagram of a syringe sleeve combination according to Example 3 of the present application. [Figure 19] FIG. 10 is an exploded schematic view of a syringe sleeve according to a third embodiment of the present invention. [Figure 20] FIG. 10 is a schematic diagram of a syringe sleeve connection according to Example 4 of the present application. [Figure 21] FIG. 10 is a schematic diagram of a syringe sleeve combination according to Example 5 of the present application. [Figure 22] FIG. 10 is an exploded schematic view of a syringe sleeve of a connecting tube with a needle according to a sixth embodiment of the present invention. [Figure 23] 13 is a schematic view of the connection between the needle and the connecting tube of the first example of the syringe sleeve of the connecting tube with a needle according to Example 6 of the present application. FIG. [Figure 24] FIG. 13 is a schematic diagram of a second example of the connection of the syringe sleeve of the needle-equipped connecting tube according to the sixth embodiment of the present invention. [Figure 25] FIG. 13 is a schematic view of a third example of the connection of the syringe sleeve of the needle-equipped connecting tube according to the sixth embodiment of the present invention. [Figure 26] 1 is a photograph of a tissue section of the fundus in Test Example 1 of the present application. [Figure 27] 1 is a photograph of a tissue section of the fundus in Test Example 4 of the present application. [Figure 28] 1 is a photograph of a tissue section of the fundus in Test Example 5 of the present application. [Figure 29] 1 is a photograph of a tissue section of the fundus in Test Example 6 of the present application. [Figure 30] 1 is a photograph of a tissue section of the fundus in Test Example 7 of the present application. [Figure 31] 1 is a photograph of a tissue section of the fundus in Test Example 8 of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0074] The technical means of the present application will be described in more detail below with reference to test examples and specific examples, but it should not be understood that the scope of the above subject matter of the present application is limited to the following examples, and all techniques realized based on the content of the present invention belong to the scope of the present application.

[0075] This application incorporates the entire contents of the applicant's prior application (PCT / CN2022 / 107104, titled "Ophthalmic Injection Assembly, Injection Device, and Method of Use") into this application as part of the present application. The injection site, needle specifications, needle effective length, blade length, blade puncture force, etc. are further explained below.

[0076] 1. Injection site Injection sites described herein: any area of ​​the conjunctiva, such as supranasal, subnasal, supratemporal, or subtemporal. Any point in any area of ​​the conjunctiva between the iris and limbus, such as the nasal, infranasal, supratemporal, or infratemporal area, about 3-9 mm from the limbus, about 4-8 mm from the limbus, about 4-7 mm from the limbus, about 6-8 mm from the limbus, about 7-8 mm from the limbus, or about 4-5 mm from the limbus. The distance from the limbus can be selected to be about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, or about 8 mm. 2. Needle specifications: The needle may be selected from commercially available conventional syringe needles, such as 28G, 30G, 31G, 32G, 33G, and 34G needles, or may be customized and manufactured using conventional processes for syringe needles.

[0077] Needle Gauge Parameters: The tip of the needle is typically sharp, beveled, or otherwise configured to puncture the ocular surface (e.g., the sclera). The needle employed may have any suitable gauge, such as about 25G, about 26G, about 27G, about 28G, about 29G, about 30G, about 31G, about 32G, about 33G, about 34G, about 35G, or about 36G. The needle wall may have any suitable thickness. For example, in addition to conventional wall thickness (RW), the needle wall may be designed as thin-walled (TW), extremely / ultra-thin-walled (XTW / UTW), or extremely thin-walled (XXTW). These names are well known to those skilled in the art. For example, the needle may be a thin gauge cannula or needle. In certain variations, the needle gauge may range from about 25G to about 36G. In other variations, the needle gauge may range from about 27G to about 35G. In still other variations, the needle gauge may range from about 30G to about 33G.

[0078] Effective needle length: The effective needle length is the length exposed from the clamping port at the injection end of the connecting barrel, and the effective needle length is about 1400 microns or less, about 1300 microns or less, about 1200 microns or less, about 1100 microns or less, about 1000 microns or less, about 900 microns or less, about 800 microns or less, about 850 microns or less, about 700 microns or less, about 650 microns or less, about 500 microns or less, and about 450 microns or less. In some embodiments, the effective needle length may be about 700 microns. In other embodiments, the effective needle length may be about 750 microns, about 800 microns, about 850 microns, about 900 microns, about 950 microns, about 1000 microns, about 1100 microns, or about 1350 microns.

[0079] Cutting edge length: The cutting edge length is the linear distance from the inner edge of the proximal end of the needle wall at the liquid outlet at the tip of the needle to the distal edge of the outer needle wall at the liquid outlet at the tip of the needle, and is about 800 microns or less, about 700 microns or less, about 650 microns or less, about 600 microns or less, about 550 microns or less, about 500 microns or less, about 450 microns or less, about 400 microns or less, about 350 microns or less, about 300 microns or less, or about 250 microns or less. In some embodiments, the cutting edge length may be about 550 microns, and in other embodiments, the cutting edge length may be about 700 microns, or about 650 microns, or about 600 microns, or about 500 microns, or about 450 microns, or about 300 microns, or about 250 microns.

[0080] Blade surface piercing force: The blade surface puncture force of the liquid outlet at the tip of the needle is about 0.7 N or less, about 0.65 N or less, about 0.5 N or less, about 0.4 N or less, or about 0.3 N or less, which limits access to the desired location within the target tissue (e.g., the choroidal space and / or the vitreous body) and forms a drug solution delivery channel. In some embodiments, the blade surface puncture force may be about 0.5 N, and in other embodiments, the blade surface puncture force may be about 0.7 N, or about 0.65 N, or about 0.4 N, or about 0.3 N.

[0081] Needle base length: The hub length of the needle portion is the length exposed from the top surface of the convex rib of the needle holder, and the hub length is about 10 mm or less, about 9 mm or less, about 8 mm or less, about 7 mm or less, about 6 mm or less, about 5 mm or less, about 4 mm or less, or about 3 mm or less. In some embodiments, the hub length may be about 6.5 mm. In other embodiments, the hub length may be about 6.9 mm, about 7.0 mm, about 7.5 mm, about 7.8 mm, about 8.0 mm, or about 8.2 mm. 3.rAAV-anti-VEGF

[0082] As used herein, the term "rAAV-anti-VEGF" refers to an rAAV containing a VEGF antagonist expressed for the treatment of ocular diseases, wherein the VEGF antagonist is preferably aflibercept, conbercept, ranibizumab, or bevacizumab.

[0083] Additionally, as used herein, the term "syringe" has the definition commonly understood in the art and can include a syringe barrel and a pusher, of which the syringe barrel may be provided with at least a syringe barrel flange for convenient gripping by an operator. A "syringe" can be pre-equipped with a needle, or an operator can select a needle suitable for injecting into a patient.

[0084] Example 1 1 and 3, this embodiment provides a syringe sleeve including a connecting tube 1 and a positioning tube 2. The connecting tube 1 and the positioning tube 2 are both cylindrical, and the positioning tube 2 is used to fit onto the outside of the syringe 4 (FIG. 11). The connecting tube 1 has two ends, an injection end 11 and a connecting end 12, respectively. The injection end 11 is provided with an annular boss 111 and a clamping port 112. As shown in FIGS. 1, 3, and FIGS. 15 to 17, which will be described later, the annular boss 111 has a stepped structure that surrounds the entire inner circumference of the injection end 11. The annular boss 111 is used to engage the needle holder 33 of the needle portion 3, thereby regulating the position of the needle portion 3. As shown in FIG. 2, the needle holder 33 of the needle portion 3 is provided with a convex rib 31, which engages the needle holder 33 with the annular boss 111, preventing the needle holder 33 from moving outside the injection end 11. Therefore, the injection end 11 of the connecting barrel 1 can use the annular boss 111 to limit the length of the needle 3 exposed from the connecting barrel 1, and further limit the exposed length of the tip of the needle 3, limiting the exposed length of the tip of the needle 3 to a necessary range and meeting the requirements for the tip of the needle 3 during injection. This allows the tip of the needle 3 to just reach the sclera of the eye tissue during injection, making it suitable for injection into the target tissue of the eye.

[0085] In this embodiment, the top end of the positioning tube 2 is the end of the positioning tube 2 that faces the tail of the pusher of the syringe 4 (after installation), and the bottom end of the positioning tube 2 is the end of the positioning tube 2 that faces the connecting tube 1. The outer diameter of the connecting end 12 of the connecting tube 1 matches the inner diameter of the bottom end of the positioning tube 2, and the connecting end 12 of the connecting tube 1 is placed inside the positioning tube 2 from the bottom end of the positioning tube 2 and connected. The connecting end 12 of the connecting tube 1 is provided with a male thread, and the inner wall of the bottom end of the positioning tube 2 is provided with a female thread. The connecting end 12 is connected to the positioning tube 2 via a threaded connection, and the overall length of the connecting tube 1 and the positioning tube 2 can be adjusted by rotation. When the connecting end 12 of the connecting tube 1 is rotated to the end of the thread, the connecting tube 1 and the positioning tube 2 are connected in their final state and cannot be rotated any further. At this time, the tip of the needle 3 reaches the set length, just exposed from the injection end 11 of the connecting tube 1.

[0086] Continuing to refer to FIG. 2 , three convex ribs 31 are provided around the top end of the needle holder 33 of the needle portion 3 in this embodiment, and are evenly spaced around the needle holder 33. The convex ribs 31 form a convex edge arranged longitudinally along the needle hub 34 around the needle holder 33, so that the outer diameter of the top end of the needle holder 33 is larger than the annular boss 111. The convex ribs 31 can engage or abut against the annular boss 111, and the length of the needle portion 3 exposed from the injection end 11 is limited by the annular boss 111. The convex ribs 31 are provided to facilitate engagement of the needle holder 33 within the injection end 11 of the connecting barrel 1. Therefore, the distance from the annular boss 111 to the clamping port 112 minus the length of the needle hub 34 equals the exposed length of the tip of the needle portion 3. During use, when the convex ribs 31 engage with the annular boss 111, the needle portion 3 reaches its final position and cannot be extended any further. In this way, by accurately designing the positions of the needle hub and the annular boss 111, it is possible to ensure that only a set length of the tip of the needle 3 is exposed, thereby meeting the requirements for injection into ocular tissue. Furthermore, when the positioning barrel 2, after being fixedly connected to the connecting barrel 1 and the syringe barrel, is rotated and tightened, the connecting barrel 1 abuts against the syringe barrel flange 41, and the convex rib 31 of the needle 3 engages with the annular boss 111. Therefore, by accurately designing the positions of the syringe barrel flange 41 and the annular boss 111, the connecting barrel 1 and the positioning barrel 2 can adjust the exposed length of the tip of the needle 3 and restrict the position of the needle. In addition, the needle holder 33 can be quickly connected to the syringe located in the positioning barrel 2 to form an integrated injection device, and the syringe 4 can lock the needle holder 33. As can be seen from the above description, by using the syringe sleeve provided in this embodiment, there is no need to repeatedly measure and check the distance and position at which the needle will pierce the eye tissue before injection, which saves time and effort. It also avoids the needle from retracting toward the syringe or shifting the injection position due to the influence of the tissue at the injection site during eye injection, which could result in an inaccurate dose and affect the injection effect.

[0087] When the operator applies thrust to the syringe pusher to move the pusher within the syringe, the syringe 4 locks the needle holder 33, preventing the tip of the needle 3 from moving with the movement of the pusher, thereby preventing excessive extension into the target tissue of the eye and preventing damage or penetration of the target tissue of the eye.

[0088] Referring to FIG. 3 , in this embodiment, the injection end 11 of the connecting barrel 1 is the end facing the ocular tissue, from which the tip of the needle portion 3 extends and is used for injection. A clamping port 112 is provided at the end of the injection end 11 of the connecting barrel 1, i.e., the end facing the ocular tissue of the connecting barrel 1. The clamping port 112 is a circular opening for pressing against the ocular tissue at the injection site. The clamping port 112 has an annular end surface 114, which is the end face of the injection end 11. The annular end surface 114 is annular, and includes an inner curve and an outer curve, with a certain distance between the inner curve and the outer curve, both of which are smoothly transitioning curves. The space enclosed by the inner curve is the clamping port 112. The shortest line segment passing through the injection point and with both ends located on the inner curve is the minimum inner diameter of the annular end surface of the clamping port, also referred to as the inner diameter of the clamping port. The portion between the inner curve and the outer curve is the wall thickness of the injection end 11. In this embodiment, the clamping port 112 has a circular opening, and the annular end surface 114 is shown in FIG. 4. In other embodiments, an elliptical annular end surface as shown in FIG. 5 or a polygonal annular end surface as shown in FIG. 6 may be employed. Clamping ports of different shapes, such as circular, elliptical, hexagonal, octagonal, square, or irregular, can be realized to press the ocular tissue of the clamping port. The annular end surface 114 is preferably a circular annular end surface, which not only helps to avoid damage to the conjunctiva but also better aids in the recovery of the ocular tissue in the process.

[0089] 7, when in use, the edge of the circular opening of the clamping port 112 comes into contact with and presses against the ocular tissue, causing the ocular tissue at that site to form a protrusion at the clamping port 112 toward the injection end 11, at which point the tip of the needle 3 pierces the target ocular tissue at the injection site. By clamping an appropriate amount of ocular tissue between the clamping port 112 and forming a clear protrusion within the clamping port 112, the drug solution can be smoothly delivered to the target site, improving the success rate of injection and effectively preventing reflux and diffusion of the drug solution under the conjunctiva.

[0090] 3, in this embodiment, injection end 11 is further provided with a cylindrical chamber 113 located near clamping port 112 within injection end 11, one end of chamber 113 being closed by needle holder 33, i.e., needle holder 33 abuts against chamber 113 to separate chamber 113 from the inside of connecting tube 1, and the other end of chamber 113 is closed by clamping port 112 pressing against the ocular tissue, i.e., this end of chamber 113 is clamping port 112, which is closed by contacting the outside. By providing chamber 113, if backflow occurs, the backflowing medicinal solution is contained within sealed chamber 113, and when clamping port 112 is separated from the ocular tissue, the medicinal solution is adsorbed into chamber 113 by a siphoning effect, making it less likely to leak from sealed chamber 113 and preventing the medicinal solution from dripping onto the ocular tissue.

[0091] In this embodiment, the injection tip is made of a transparent material, such as a polypropylene material. The transparent material allows the operator to easily observe the reflux of the medicinal liquid and quickly determine whether the injection was successful. A transparent viewing window can be opened on the side wall of the injection tip, which also facilitates easy observation. The transparent injection tip or the see-through viewing window can also be equipped with a scale, which allows for more accurate determination of the reflux and allows the operator to observe the volume of the refluxed medicinal liquid, making it easier to estimate the amount of injected medicinal liquid.

[0092] The needle 3 is available in multiple sizes, and the syringe 4 can employ needles 3 of different sizes to meet injection needs. The needle hubs 34 of the needles 3 of different sizes have different lengths between 5 and 10 mm. In this embodiment, the length of the needle hub 34 of the needle 3 may be selected from 6.7 mm, 6.9 mm, 7.1 mm, 7.5 mm, 7.8 mm, 8.0 mm, 8.2 mm, and 8.5 mm, etc. Needles 3 with needle hubs 34 of different lengths can be individually selected according to the different conditions and needs of each patient.

[0093] Example 2 As shown in Figures 9-10 and 12-17, this embodiment provides a syringe sleeve with a structure similar to that of the first embodiment. However, the difference is that the connecting tube 1 has a locking groove 13 and a mounting groove 21 for attaching the syringe barrel flange 41 to the positioning tube 2. The mounting groove 21 is a gap formed between the locking tag 22 and the flange mount 23. A positioning structure 24 is also provided on the outside of the positioning tube 2. This syringe sleeve utilizes the structure of a conventional syringe to secure the syringe barrel flange 41 to the positioning tube 2, thereby converting the operator's grip on the syringe 4 into the operator's grip on the syringe sleeve, making use and operation more convenient. By connecting the connecting tube 1 and the positioning tube 2, the overall length of the connecting tube 1 and the positioning tube 2 can be easily adjusted. Adjusting the relative positions of the connecting tube 1 and the positioning tube 2 allows the exposed length of the needle tip 3 to be adjusted, thereby positioning the needle tip 3 and ensuring that the exposed length of the needle tip 3 exactly meets the requirements for injection into ocular tissue.

[0094] 9, in this embodiment, the outer diameter of the connecting end 12 of the connecting tube 1 is the same as the inner diameter of the positioning tube 2. The connecting tube 1 is connected to the positioning tube 2 by placing one end of the positioning tube 2 facing the tail of the syringe 4 pusher (the upper end of the positioning tube 2 in FIG. 9) on the positioning tube 2. That is, after the connecting tube 1 and the positioning tube 2 have a common central axis, the injection end 11 of the connecting tube 1 is placed into the positioning tube 2 from the one end of the positioning tube 2 facing the tail of the syringe 4 pusher. After being placed, the injection end 11 of the connecting tube 1 extends from the other end of the positioning tube 2 (the lower end of the positioning tube 2 in FIG. 9). The connecting end 12 of the connecting tube 1 is provided with an external thread, and the inner wall of the positioning tube 2 is provided with an internal thread, one end of which is spaced from the other end of the positioning tube 2. This spacing facilitates the external thread of the connecting tube 1 to always align with the internal thread of the positioning tube 2 when the connecting tube 1 rotates, maintaining the connection and preventing the connecting tube 1 from coming off the positioning tube 2. The connecting end 12 is connected to the positioning barrel 2 by rotation, and the overall length of the connecting barrel 1 and the positioning barrel 2 can be adjusted by rotation. The threaded connection allows the relative lengths of the connecting barrel 1 and the positioning barrel 2 to be adjusted, thereby realizing overall length adjustment. After the syringe 4 is attached to the syringe sleeve, the syringe barrel flange 41 abuts against the connecting end 12, limiting the rotational retraction distance of the connecting end 12 within the positioning barrel 2. The syringe 4 can be integrally assembled with the positioning barrel 2, allowing the position of the connecting end 12 of the connecting barrel 1 within the positioning barrel 2 to be adjusted. The final retraction position of the connecting end 12 is when the end of the connecting end 12 abuts against the syringe barrel flange 41, at which point the connecting end 12 cannot be retracted any further, thereby realizing the anti-retraction function of the connecting barrel.

[0095] 10 to 12, in this embodiment, the positioning tube 2 is provided with a lock tag 22, a flange mount 23, and a position restriction structure 24. The top end of the positioning tube 2 is one end of the positioning tube 2 that faces the tail of the syringe 4 pusher after the syringe 4 is attached, and the bottom end of the positioning tube 2 is one end of the positioning tube 2 that faces the connecting tube 1 after the positioning tube 2 is connected to the connecting tube 1. The top end of the positioning tube 2 is provided with a flange mount 23. The flange mount 23 is a mount for attaching the syringe barrel flange 41 and is used to support one side of the syringe barrel flange 41. The top end of the positioning tube 2 is connected to a lock tag 22 that locks the other side of the syringe barrel flange 41. The lock tag 22 includes two structures symmetrically arranged on the top end of the positioning tube 2. The lock tag 22 is shaped like a "7," and the bottom ends of the lock tag 22 are connected to both sides of the flange mount 23 of the positioning tube 2. The two lock tags 22 are arranged relative to each other and have a gap between them. This gap allows the syringe barrel flange 41 to pass vertically when the syringe 4 is rotated, thereby engaging the syringe barrel flange 41 in the horizontal position corresponding to the mounting groove 21. There is a gap between the locking tag 22 and the flange mount 23, which is the mounting groove 21. After the syringe barrel flange 41 corresponds to the horizontal position of the mounting groove 21, the syringe barrel flange 41 further rotates to engage horizontally with the mounting groove 21. The mounting groove 21 provides a space in which the syringe barrel flange 41 can be locked in the positioning barrel 2, facilitating the fixation of the syringe 4 and the positioning barrel 2. In this embodiment, an arc-shaped protrusion 26 is provided at the bottom of the locking tag 22, and an arc-shaped protrusion 26 can also be provided at the top of the flange mount 23. The arc-shaped protrusion 26 is used to lock one side of the syringe barrel flange 41. By providing the arc-shaped protrusion 26, the distance from the corresponding position of the arc-shaped protrusion 26 of the locking tag 22 to the flange mount 23 is smaller than the thickness of the syringe barrel flange 41, i.e., there is an interference fit between the syringe barrel flange 41 and the locking tag 22 and flange mount 23. The syringe barrel flange 41 is engaged and locked into the mounting groove 21 by the arc-shaped protrusion 26. Once engaged, the locked state prevents the syringe 4 from coming off the positioning barrel 2.

[0096] In this embodiment, the positioning tube 2 is provided with a position restriction structure 24 located on the outside of the positioning tube 2. As shown in FIG. 11, the position restriction structure 24 may be a ring structure located on one side of the positioning tube 2 and used to lock an operator's finger. This ring structure facilitates finger positioning. During use, the operator's index finger or other fingers are inserted and fixed into the ring structure, allowing the operator to conveniently hold the syringe sleeve and fix the fingers and syringe sleeve relative to each other, making operation easier. The position restriction structure 24 may also employ a protrusion or notch structure, as shown in FIGS. 13 to 15.

[0097] 16 and 17, in this embodiment, two locking grooves 13 are further provided in opposing positions within the connecting tube 1, although one or more locking grooves 13 may be provided. The locking grooves 13 are formed by axially recessing the inner wall of the connecting tube 1, so that the inner wall of the connecting tube 1 has two locking grooves 13 of the same length that are positioned opposite each other. The locking grooves 13 are used to lock onto the outer surfaces of the needle holders 33 of the needles 3, and the outer surfaces of the syringe barrels may also be formed in a shape that matches the locking grooves 13. In this embodiment, the outer surfaces of the needle holders 33 are provided with protrusions 32, the shape and size of which match the cross section of the locking grooves 13, i.e., protrusions 32 are provided on both sides of the needle holders 33, and the two protrusions 32 precisely restrict the needles 3 within the locking grooves 13, allowing the needles 3 to move axially along the locking grooves 13 within the connecting tube 1. After the position of the protrusion 32 passes the engaging groove 13, the needle 3 is released from the engagement groove 13 and can rotate relative to the connecting barrel 1. As a result, when the syringe 4 is placed in the syringe, the syringe 4 can always maintain unidirectional movement without shaking under the guidance of the needle 3, thereby avoiding contact between the needle 3 and the inner wall of the connecting barrel 1 during the process of placing the syringe 4 and keeping the needle 3 clean.

[0098] Example 3 18-19, this embodiment provides a syringe sleeve having almost the same structure as that of the first embodiment, except that the connecting tube 1 is connected to one end of the positioning tube 2 facing the needle portion 3, i.e., the connecting end 12 of the connecting tube 1 is docked in the opposite direction to the bottom end of the positioning tube 2.

[0099] Referring to Figure 19, in this embodiment, the injection end 11 of the connecting tube 1, the engagement groove 13, and the structure of the connecting tube 1 are the same as in Example 1, but the length of the connecting tube 1 is shorter than in Example 1. The bottom end of the positioning tube 2 in this embodiment has a one-stage extension, and the overall length of the positioning tube 2 is longer than in Example 1. The connecting end 12 of the connecting tube 1 is provided with a female thread, and the extension at the bottom end of the positioning tube 2 is provided with a male thread. The inner diameter of the connecting end 12 of the connecting tube 1 matches the outer diameter of the extension of the positioning tube 2, allowing the two to be connected by threads. When connecting, when the connecting tube 1 rotates to the top end of the threaded extension, the end of the connecting end 12 of the connecting tube 1 abuts the top end of the extension of the positioning tube 2. At this point, the overall length of the connecting tube 1 and the positioning tube 2 no longer decreases, and the connection is in its final position. To use, first place the syringe 4 in the positioning tube 2, and then insert the syringe barrel flange 41 into the mounting groove 21 of the positioning tube 2 to secure it. At this time, the syringe 4 partially extends from the positioning tube 2. Furthermore, the connecting barrel 1 is inserted from one end of the needle 3 of the syringe 4 so that the needle 3 of the syringe 4 is positioned at the injection end 11 of the connecting barrel 1, and then the connecting barrel 1 is rotated to dock the connecting barrel 1 with the positioning barrel 2. When the connecting barrel 1 is rotated to the final position, the exposed length of the tip of the needle 3 just meets the injection length set for injection into ocular tissue, satisfying the requirements for injection into ocular tissue.

[0100] Example 4 This embodiment provides a syringe sleeve with almost the same structure as that of the third embodiment, except that the connecting tube 1 and the positioning tube 2 are connected by a snap fit.

[0101] Referring to Figure 20, in this embodiment, the injection end 11 of the connecting tube 1, the fastening groove 13, and the positioning tube 2 have the same structures as in Example 3. However, the connecting end 12 of the connecting tube 1 is provided with a snap fit, and the bottom end of the positioning tube 2 has a buckle groove matching the snap fit. The outer diameter of the connecting end 12 of the connecting tube 1 is equal to the inner diameter of the bottom end of the positioning tube 2. Therefore, the connecting end 12 of the connecting tube 1 can be snap-fitted to the positioning tube 2 by simply inserting it. More specifically, buckles are provided on both sides of the connecting end 12 of the connecting tube 1, and the buckles protrude outward from both sides of the connecting end 12. The buckle groove on the inner wall of the bottom end of the positioning tube 2 exactly matches the shape and size of the snap fit. To use the syringe 4, first place the syringe 4 in the positioning tube 2, and then insert the syringe barrel flange 41 into the mounting groove 21 of the positioning tube 2 to secure it. At this time, the syringe 4 partially extends from the positioning tube 2. Next, the connecting tube 1 is inserted into one end of the needle 3 of the syringe 4 so that the needle 3 is positioned at the injection end 11 of the connecting tube 1, and the connecting tube 1 is docked with the positioning tube 2. When the connecting tube 1 is inserted into the positioning tube 2 and connected to it, and reaches its final position, the snap fit is exactly engaged with the buckle groove. At this time, the exposed length of the tip of the needle 3 exactly meets the injection length set for injection into ocular tissue, and meets the requirements for injection into ocular tissue.

[0102] Example 5 This embodiment provides a syringe sleeve. Part of the structure of this embodiment is the same as that of the second embodiment. The only part that is the same is the connecting tube 1. The positioning tube 2 is provided with only the mounting groove 21, and does not have a position restriction structure 24.

[0103] Referring to FIG. 21 , in this embodiment, the connecting barrel 1 has two ends, an injection end 11 and a connecting end 12, respectively. The connecting end 12 of the connecting barrel 1 is provided with a male thread, and the bottom end of the positioning barrel 2 is provided with a female thread. The connecting end 12 of the connecting barrel 1 is mated with the positioning barrel 2 via a threaded connection. The top end of the positioning barrel 2 is further provided with a mounting groove 21 for mounting a syringe barrel flange 41. The mounting groove 21 is recessed on the outer side of the top of the positioning barrel 2 and need only be large enough to fit the syringe barrel flange 41. The injection end 11 of the connecting barrel 1 is provided with a contracting section 115, the cross-sectional size of which gradually increases in the direction away from the clamping port 112 of the injection end 11. The internal opening of the contracting section 115 is smaller than the top end of the needle holder 33, and engages the top end of the needle holder 33 of the needle portion 3 of the syringe 4, thereby limiting the continued movement of the needle holder 33 and realizing the needle positioning function. Furthermore, since the injection end 11 can pass through the hub of the needle 3, the tip of the needle 3 can be exposed at the injection end 11 of the connecting barrel 1 after the connecting barrel 1 and the positioning barrel 2 are connected. The syringe sleeve allows the operator to change the conventional grip of the syringe 4 to the operator gripping the syringe sleeve, making it more convenient to use and operate. By connecting the connecting barrel 1 and the positioning barrel 2, the overall length of the connecting barrel 1 and the positioning barrel 2 can be easily adjusted, and the exposed length of the tip of the needle 3 can be adjusted by adjusting the relative positions of the connecting barrel 1 and the positioning barrel 2. This allows the position of the tip of the needle 3 to be controlled, so that the exposed length of the tip of the needle 3 can be adjusted to exactly meet the requirements for injection into ocular tissue.

[0104] When the connecting tube 1 and the positioning tube 2 adjust the exposed length of the tip of the needle 3 to regulate the needle position, the syringe 4 can lock the needle holder 33. Repeated measurements and checks are not required during use, saving a lot of time and effort. It also prevents the needle from retracting toward the syringe or shifting the injection position due to the influence of the injection site tissue during eye injection, resulting in an inaccurate dose and affecting the injection effect.

[0105] When the operator applies thrust to the syringe pusher to move the pusher within the syringe, the syringe locks the needle holder 33, preventing the tip of the needle from moving with the movement of the pusher, thereby preventing it from overextending into the target tissue of the eye and damaging or penetrating the target tissue of the eye.

[0106] Example 6 22 to 25, this embodiment provides a syringe sleeve with a needle. The syringe sleeve is fitted onto the outside of the syringe and includes a connecting tube 1 and a positioning tube 2. The connecting tube 1 and the positioning tube 2 of this embodiment have substantially the same structure as those of the second embodiment. The difference is that, as shown in FIG. 22, the connecting tube 1 and the positioning tube 2 are indirectly connected using a luer interface 5, the connecting tube 1 and the needle 3 are connected by a screw, position control structures 24 are provided on both sides of the positioning tube, and the connecting end 12 of the connecting tube 1 is connected to the needle holder 33 of the needle 3. The overall length of the connecting end 12 of the connecting tube 1 and the needle holder 33 can be adjusted, and the overall length from the connecting end 12 of the connecting tube 1 to the needle holder 33 can be changed at least once from the initial connection position and state to the final connection position and state, thereby realizing the overall length of the connecting tube 1 and the needle holder 33 to be changed.

[0107] As shown in Figure 23, in this embodiment, the inner wall of the connecting end 12 of the connecting barrel 1 is provided with a single-stage female thread along the axial direction, and the outer surface of the needle holder 33 is provided with a male thread that matches the connecting end 12. When the needle holder 33 and the connecting barrel 1 are rotated and tightened in the forward direction, the tip of the needle 3 is exposed from the injection end 11 of the connecting barrel 1, and the exposed length exactly meets the requirements for injection into ocular tissue. The connection between the positioning barrel 2 and the syringe barrel flange is the same as in Example 2, and is fixed by inserting the syringe flange into the mounting groove. After the positioning barrel 2 is fixed and connected to the syringe barrel, the syringe and needle holder 33 are quickly connected via the Luer interface 5 to form an integrated injection device. The syringe sleeve is indirectly connected to the connecting barrel 1 by the needle 3, and the exposed length of the tip of the needle 3 is limited by the injection end 11, realizing the positioning of the tip of the needle 3 and meeting the requirements for injection into ocular tissue. Furthermore, the indirect connection and adjustment between the needle part 3 and the connecting tube 1 can be completed quickly, and there is no need for repeated measurement or confirmation during use, which saves a lot of time and effort.

[0108] 24, a position-limiting flange 25 is provided at the bottom end of the positioning barrel 2. When the needle holder 33 and the connecting barrel 1 are rotated and tightened, the connecting barrel 1 moves toward the luer interface 5 located at the injection end of the syringe and abuts against the position-limiting flange 25 of the positioning barrel 2, preventing the connecting barrel 1 from retracting. At this time, the convex rib 31 of the needle 3 engages with the annular boss 111. The precise design of the position of the position-limiting flange 25 and the annular boss 111 ensures that the needle holder 33 and the luer interface 5 can be quickly connected to form an integrated injection device, ensures that the exposed length of the tip of the needle 3 is limited by the injection end 11, and allows the luer interface 5 to lock the needle holder 33.

[0109] In this way, there is no need to repeatedly measure or check during use, which not only saves a lot of time and effort, but also prevents the needle from retracting toward the syringe or the injection position from shifting due to the influence of the tissue at the injection site during eye injection, resulting in an inaccurate dose and affecting the injection effect.

[0110] When the operator applies thrust to the syringe pusher to move the pusher within the syringe, the syringe locks the needle holder, preventing the tip of the needle from moving with the movement of the pusher, preventing it from excessively extending into the target tissue of the eye and damaging or penetrating the target tissue of the eye.

[0111] 25, in this embodiment, the outer wall of the positioning barrel 2 between the positioning flange 25 and the bottom end of the positioning barrel 2 is provided with a male thread that mates with the female thread of the connecting barrel 1. After the needle holder 33 is placed into the connecting barrel 1 through the connecting end 12 of the connecting barrel 1, the connecting end 12 is directly coupled to the bottom end of the positioning barrel 2 after being fixedly connected to the syringe barrel. The connecting barrel 1 and the positioning barrel 2 rotate relative to each other, and the connecting barrel 1 moves toward the bottom end of the positioning barrel 2 until the tip of the needle 3 is exposed from the injection end 11 of the connecting barrel 1. When the connecting end 12 abuts against the positioning barrel 2 and the positioning flange 25 cannot move any further, the convex rib 31 of the needle 3 engages with the annular boss 111, and the exposed length of the tip of the needle 3 just meets the requirements for injection into ocular tissue, allowing the syringe 4 to lock the needle holder 33.

[0112] In this way, repeated measurements and checks are not required during use, saving time and effort, and the risk of the needle retracting toward the syringe or misalignment of the injection position due to the influence of the tissue at the injection site during eye injection, resulting in an inaccurate dose and affecting the injection effect, is avoided. Also, the risk of the tip of the needle 3 being pricked or the tip of the needle being damaged due to the tip of the needle 3 being exposed outside the connecting tube 1 too early is avoided.

[0113] When the operator applies thrust to the syringe pusher to move the pusher within the syringe, the syringe locks the needle holder, preventing the tip of the needle from moving with the movement of the pusher, preventing it from excessively extending into the target tissue of the eye and damaging or penetrating the target tissue of the eye.

[0114] In this embodiment, different specifications of needle parts 3 can be selected and connected to the connecting end 12 of the connecting tube 1 to meet the needs of people of different ages and the different needs of the actual eye tissue thickness parameters of different patients.

[0115] In this embodiment, the outer wall of the positioning tube between the position control flange 25 and the bottom end of the positioning tube 2 is connected to the connecting tube 1 by screwing, or can be connected by conventional connection and fixing methods such as insertion / removal, snap fastening, or crimping.

[0116] Example 7 This embodiment provides an injection assembly that can employ the syringe sleeve of any of the first to sixth embodiments. For example, as shown in FIG. 11 , the injection assembly may include a syringe sleeve, a syringe 4, and a needle 3, and the syringe assembly is a structure in which the syringe 4 and the syringe sleeve are assembled together. The syringe 4 is placed in the connecting barrel 1 and the positioning barrel 2, and the syringe barrel flange 41 of the syringe 4 is engaged with the mounting groove 21 to lock the syringe 4 to the positioning barrel 2. The length of the needle 3 of the syringe 4 exposed from the connecting barrel 1 can be adjusted using the connecting barrel 1 and the positioning barrel 2 or the needle holder 33 of the needle 3, ultimately maintaining the exposed length of the needle 3 at a set length. This injection assembly can be combined with the syringe 4, and not only can the length of the tip of the needle 3 be conveniently adjusted to the required length and precision, but it also helps the operator operate with one hand, making it more convenient to use and operate. In addition, when the connecting tube 1 and the positioning tube 2 adjust the exposed length of the tip of the needle portion 3 and regulate its position, the syringe 4 located inside the positioning tube 2 is quickly connected to the needle holder 33 to form an integrated injection device and lock the needle holder.

[0117] In this way, there is no need to repeatedly measure or check during use, saving a lot of time and effort, and it also avoids the needle from retracting toward the syringe or shifting the injection position due to the influence of the tissue at the injection site during eye injection, which could result in an inaccurate dose and affect the injection effect.

[0118] When the operator applies thrust to the syringe pusher to move the pusher within the syringe, the syringe locks the needle holder, preventing the tip of the needle from moving with the movement of the pusher, preventing it from excessively extending into the target tissue of the eye and damaging or penetrating the target tissue of the eye.

[0119] Example 8 This embodiment provides a method for using a syringe sleeve, which can employ the syringe sleeves of embodiments 1 to 5. When embodiment 2 is employed, the method for using the syringe sleeve includes the following:

[0120] A1: First, place the connecting tube 1 on the top end of the positioning tube 2, then place the syringe 4 into the connecting tube 1 and the positioning tube 2 from the top end of the positioning tube 2. The syringe 4 is completely placed under the guidance of the engaging groove 13 of the connecting tube 1. The needle 3 of the syringe 4 is located at the injection end 11 of the connecting tube 1. Next, rotate the connecting tube 1 and the positioning tube 2 to connect them together with a screw connection.

[0121] A2: As the connecting barrel 1 continues to rotate, the syringe barrel flange 41 moves to the corresponding position in the mounting groove 21 as the connecting barrel 1 rotates. Then, the connecting barrel 1 is driven to rotate and engage the syringe barrel flange 41 into the mounting groove 21 to fix it, or the syringe barrel flange 41 is manually engaged and fixed into the mounting groove 21. After the syringe barrel flange 41 is engaged, the syringe 4 is locked to the positioning barrel 2. At this time, the tip of the needle 3 is located within the injection end 11 of the connecting barrel 1 and is not exposed. The rotation direction of steps A1 and A2 is set to the forward direction.

[0122] A3. When connecting barrel 1 is rotated in the opposite direction, the overall length between connecting barrel 1 and positioning barrel 2 gradually decreases, and connecting end 12 of connecting barrel 1 retracts. When connecting end 12 of connecting barrel 1 exactly abuts the surface of syringe barrel flange 41, the end of connecting end 12 of connecting barrel 1 is positioned by syringe barrel flange 41, preventing connecting barrel 1 from retracting any further, and connecting barrel 1 and positioning barrel 2 reach their final position. At this time, needle holder 33 of needle 3 is locked by annular boss 111, the tip of needle 3 is exposed exactly the set length from syringe end 11 of connecting barrel 1, needle holder 33 abuts against syringe 4 and is locked by syringe 4, preventing needle 3 from retracting any further. By changing the rotation method of connecting barrel 1, the connection between connecting barrel 1 and positioning barrel 2 is divided into two stages. The first is a rotational connection, which realizes the connection between connecting barrel 1 and positioning barrel 2. The second is reverse rotation, which allows the adjustment of the overall length of the connecting tube 1 and the positioning tube 2, and further adjusts the exposed length of the tip of the needle part 3, so that the syringe 4 of the positioning tube 2 can be quickly connected to the needle part 3 to form an integrated injection device and lock the needle holder 33.

[0123] When the syringe sleeve of Example 3 is used, the method of use includes: first, fitting the positioning barrel 2 onto the syringe 4, then fitting the syringe barrel flange 41 into the mounting groove 21 and fixing it, then fitting the connecting barrel 1 onto the syringe 4 so that the needle 3 of the syringe 4 is positioned at the injection end 11 of the connecting barrel 1, and finally inserting the connecting barrel 1 into the bottom end of the positioning barrel 2 and directly connecting them by snap-fitting. After the snap-fit ​​connection, the exposed length of the tip of the needle 3 exactly matches the set length for injection into the ocular tissue.

[0124] Example 9 This example provides a method of using the syringe sleeve employing the needle (syringe) sleeve of Example 6. The method of use includes the following:

[0125] A1: First, the connecting end of the connecting tube 1 is fitted onto the needle holder 33 of the needle part 3. Next, the needle holder 33 is connected via the luer interface 5, or directly inserted into the end of the syringe fitted inside the positioning tube 2 that is close to the needle part of the syringe into which the drug has been drawn. Then, the connecting end of the connecting tube 1 is screwed onto the needle holder 33 by rotation. As the connecting tube 1 rotates and moves within the needle holder 33 towards the needle part 3, the overall length between the injection end of the connecting tube 1 and the needle holder 33 gradually decreases, and the connecting end 12 of the connecting tube 1 moves back. When the connecting end 12 of the connecting tube 1 just abuts against the base of the needle holder 33, the end of the connecting end 12 of the connecting tube 1 is locked and positioned by the syringe barrel flange 41, preventing the connecting tube 1 from moving back any further. At this time, the connecting tube 1 and the positioning tube 2 are in their final positions, the needle holder 33 is locked by the annular boss 111, the tip of the needle portion 3 is just exposed at the injection end 11 of the connecting tube 1, and the exposed length is the set length.

[0126] A2: Place the syringe barrel into the positioning barrel 2 from the top end of the positioning barrel 2, and rotate the positioning barrel 2 to move the syringe barrel flange 41 to the corresponding position in the mounting groove 21. Then, drive the positioning barrel 2 to rotate the syringe barrel flange 41 into the mounting groove 21 and fix it, or manually insert the syringe barrel flange 41 into the mounting groove 21 and fix it. After the syringe barrel flange 41 is fitted, the syringe 4 is locked to the positioning barrel 2.

[0127] A3: The positioning barrel 2 with the attached syringe barrel is rotated in the opposite direction to the connecting barrel 1 and connected to the outer wall of the needle holder 33. When the positioning barrel 2 with the attached syringe barrel rotates in the opposite direction to the connecting barrel 1 and moves toward the luer interface 5 located on the syringe 4, the distal end of the syringe barrel is inserted into the interface within the needle holder 33 until the connecting barrel 1 abuts against the position-regulating flange 25 of the positioning barrel 2, so that the distal end of the syringe barrel, i.e., the end where the needle is attached to the syringe, locks the needle holder 33.

[0128] Example 10 This example provides a method for using the injection assembly of Example 7. Taking the syringe sleeve of Example 1 as an example, this method includes:

[0129] B1, attach the drug aspirating needle to the distal end of the syringe barrel of the syringe 4 to complete the drug aspirating operation.

[0130] B2: Select a needle 3 of different specifications according to needs and attach it to the needle attachment part of the syringe 4.

[0131] B3: The connecting tube 1 is placed in the positioning tube 2 to complete the preliminary connection, and then the syringe 4 with the needle part 3 attached is placed in the connecting tube 1 and the positioning tube 2.

[0132] B4: Rotate the connecting tube 1 in the forward direction, and rotate the syringe 4 with the needle portion 3 attached by driving the connecting tube 1, so that the syringe barrel flange 41 engages with the mounting groove 21, completing the fixation of the syringe 4 and the positioning tube 2 to each other.

[0133] B5: Rotate the connecting tube 1 in the opposite direction to adjust the overall length of the connection between the connecting tube 1 and the positioning tube 2, thereby adjusting the length of the needle 3 exposed from the connecting tube 1 until the connecting tube 1 can no longer be retracted. At this time, the exposed length of the tip of the needle 3 is the set length.

[0134] B6: The operator inserts his / her fingers into the position restricting structure 24 to fix the fingers to the syringe sleeve, holds the syringe sleeve with the same hand, and waits for the operation.

[0135] B7. Use a measuring device to measure the eye to be injected and confirm the injection site.

[0136] B8. Hold the syringe sleeve by hand and align the clamping port 112 of the connecting tube 1 perpendicular to the surface of the ocular tissue at the injection site.

[0137] B9. Through cooperation between the syringe 4 and the syringe sleeve of the ophthalmic injection device, the clamping port 112 of the connecting tube 1 is brought into contact with the ocular tissue at the injection site, and force is applied to the ocular tissue at the injection site, so that the conjunctival tissue clamped by the clamping port 112 of the connecting tube 1 forms a protrusion within the injection end 11 of the connecting tube 1, and the tip of the needle portion 3 is pushed into the target ocular tissue at the injection site.

[0138] B10, working with the same hand or with a different hand, pushes the pusher of the syringe 4 to inject and administer the drug so that the drug reaches the target tissue at the administration site.

[0139] In this method, different specifications of needle 3 can be selected to meet the needs of people of different ages and the different thickness parameters of the actual ocular tissue of different patients. Positioning restriction structure 24 allows fingers to be fixed to the outside of the sleeve, making it easy to fix the fingers of one hand to the sleeve, and the clamping port 112 allows the fingers to contact the ocular tissue and press and fix it. Since the tip of needle 3 can puncture and reach the target tissue, the operator can easily inject drugs into the ocular tissue using one hand.

[0140] The method of use will be explained below using test examples, the contents of which, test examples 1 and 2, are also described in PCT / CN2022 / 107104.

[0141] Test Example 1 Test No. 1-1. An injection device was formed using the ophthalmic injection assembly and syringe of Example 10 of PCT / CN2022 / 107104. Based on the typical thickness of the sclera and choroid of New Zealand rabbits, a needle with an effective length of 700 μm and a cutting edge length of 500±50 μm was used. The sleeve clamping port 112 was circular with an inner diameter of 1.5 mm.

[0142] The effective length, i.e., the length of the tip of the needle 3 beyond the clamping port 112, is 700 μm. In other words, the distance from the tip of the needle 3 to the annular end surface is 700 μm. The needle 3 is essentially perpendicular to the annular end surface.

[0143] Test method: After pentobarbital anesthesia, proparacaine hydrochloride eye drops were used to administer surface anesthesia. 1-2 minutes after instillation, an injection was administered into the suprachoroidal space using the injection assembly. Test animals: healthy New Zealand rabbits (1.8-2.2 kg) Injection frequency: One injection in the right eye Injection reagent: 0.2% ICG, 100 μl The method of injection into the suprachoroidal space is as follows.

[0144] First step: Measure the distance with an ophthalmic caliper and confirm the injection site.

[0145] Second step: Aspirate the injection reagent and apply force to one side of the clamping port 112 through the syringe so that one side of the clamping port 112 is in close contact with the ocular tissue at the injection site and a fulcrum is formed on the ocular surface at the injection site.

[0146] Third step: Using the fulcrum as an axis, the injection device is inverted toward the other side of the clamping port 112 so that the distal end of the needle portion 3 is pierced into the eye tissue at the injection site.

[0147] Step 4: Continue to invert through the fulcrum to fasten the other side of the clamping port 112 to the ocular surface at the injection site, so that the clamping port 112 clamps the ocular tissue to form a protrusion within the sleeve, and push the distal end of the needle portion 3 vertically into the sclera to reach the target ocular tissue at the injection site.

[0148] Fifth step: The drug is injected and reaches the administration site.

[0149] During the injection process, any injection conditions, such as reflux, diffusion to the ocular surface, subconjunctival residue, diffusion, hemorrhage, or hyperemia, were recorded. The rabbits were then sacrificed, the eyeballs dissected, and planar samples of the fundus tissue were prepared. The distribution of the ICG solution in the suprachoroidal space was recorded by photography.

[0150] Test results: Observation results showed that there was no reflux after ICG injection and no residue under the conjunctiva. The results of fundus tissue sections are shown in Figure 26. All fundus tissues were transfected with ICG, and the stained fundus tissues were light green.

[0151] Test Example 2 Based on Test Example 1, the inner diameter of the clamping port 112 was adjusted without changing other conditions to investigate the effect of the inner diameter of the clamping port 112 on the backflow of the medicinal solution. The inner diameters of the clamping port 112 were 0.25 mm (Test No. 1-2), 0.5 mm (Test No. 1-3), 1.0 mm (Test No. 1-4), 2.0 mm (Test No. 1-5), 2.5 mm (Test No. 1-6), 3.0 mm (Test No. 1-7), 5.0 mm (Test No. 1-8), and 10.0 mm (Test No. 1-9).

[0152] Test Examples 1 and 2 are summarized below.

[0153] [Table 1]

[0154] Experimental results showed that when the inner diameter was 1-3 mm, there was no obvious reflux or diffusion to the ocular surface or subconjunctival space. Histological sections showed that the stained area was between 3 / 5 and 3 / 4, indicating successful injection.

[0155] Test example 3: Syringe: BD, disposable sterile syringe with needle, batch number: 300841 Needle part: 30G Syringe sleeve: the sleeve of Example 1 Injection reagent and volume: 100 μl Test steps:

[0156] 1. Ten syringes were prepared, each filled with 100 μl of purified water. An injection force of 10 ± 2 N was used to simulate ocular administration. The syringes were weighed before and after administration, and the dose and its relative standard deviation (RSD) were calculated.

[0157] 2. Using the syringe from step 1, 100 μl of purified water was extracted again, and the syringe was attached to the sleeve from Example 1. After assembly, the injection fixation force from step 1 was used to simulate ocular administration, and the syringe and fixation device were weighed before and after administration, and the dose and its relative standard deviation (RSD) were calculated to investigate the effect of the syringe sleeve provided in the examples of this application on the accuracy of the dose.

[0158] Test results: Based on the dosage and relative standard deviation before and after use of the syringe sleeve according to the embodiment of the present application (as shown in Table 2), the syringe sleeve of the present invention can significantly improve the accuracy of dosage.

[0159] [Table 2]

[0160] Test Example 4 The syringe sleeve and syringe of Example 1 are used to form a syringe assembly, in which the inner diameter of the clamping port 112 of the connecting tube 1 is 1.5 mm, and the blade length is 450±50 μm.

[0161] Test method: After pentobarbital anesthesia, ocular surface anesthesia was performed using proparacaine hydrochloride eye drops. 1 to 2 minutes after instillation, an injection into the suprachoroidal space was performed using a homemade injection device.

[0162] Test animals: healthy New Zealand rabbits (1.8-2.2 kg) Injection frequency: One injection in the right eye Injection reagent: 0.2% ICG, 100 μl Injection method: The method of injection into the suprachoroidal space is as follows.

[0163] First step: The drug aspirating needle part is attached to the distal end of the syringe barrel of the syringe 4, and after the drug aspirating operation is completed, the drug aspirating needle part is removed and replaced with the needle part 3.

[0164] In the second step, first, place the connecting tube 1 on the top end of the positioning tube 2, then place the syringe 4 into the positioning tube 2 and the connecting tube 1 from the top end of the positioning tube 2. The syringe 4 is completely placed under the guidance of the engaging groove 13 of the connecting tube 1. The needle 3 of the syringe 4 is located at the injection end 11 of the connecting tube 1. Next, the connecting tube 1 and the positioning tube 2 are connected together by a screw connection by rotation.

[0165] In the second step, the connecting barrel 1 is continued to be rotated, and as the connecting barrel 1 rotates, the syringe barrel flange 41 moves to the corresponding position in the mounting groove 21. Then, the connecting barrel 1 is driven to rotate the syringe barrel flange 41 into the mounting groove 21 and fix it, or the syringe barrel flange 41 is manually inserted into the mounting groove 21 and fixed. After the syringe barrel flange 41 is inserted, the syringe 4 is locked to the positioning barrel 2. At this time, the tip of the needle 3 is located within the injection end 11 of the connecting barrel 1 and is not exposed. At this time, the rotation direction is forward.

[0166] In the third step, rotating the connecting tube 1 in the reverse direction gradually reduces the overall length between the connecting tube 1 and the positioning tube 2, causing the connecting end 12 of the connecting tube 1 to retract. When the connecting end 12 of the connecting tube 1 precisely contacts the surface of the syringe barrel flange 41, the end of the connecting end 12 of the connecting tube 1 is locked and positioned by the syringe barrel flange 41, preventing the connecting tube 1 from retracting any further. The syringe 4 locks the needle holder 33 of the needle 3, and the connecting tube 1 and the positioning tube 2 reach their final position. At this time, the needle holder 33 of the needle 3 is locked by the annular boss 111, and the tip of the needle 3 is exposed exactly the set length from the syringe end 11 of the connecting tube 1. By changing the rotational mode of the connecting tube 1, the connection between the connecting tube 1 and the positioning tube 2 is divided into two stages. The first is a rotational connection, which realizes the connection between the connecting tube 1 and the positioning tube 2. The second is a reverse rotation, which adjusts the overall length between the connecting tube 1 and the positioning tube 2 and further adjusts the exposed length of the tip of the needle 3. The exposed length of the tip of the adjusted needle part 3 is 0.9 mm.

[0167] Fourth step: Use a measuring device to measure the eye to be injected and confirm the injection site.

[0168] Fifth step: hold the syringe sleeve by hand and make the clamping port 112 of the connecting tube 1 perpendicular to the surface of the ocular tissue at the injection site.

[0169] Step 6: Through cooperation between the syringe 4 and the syringe sleeve of the ophthalmic injection device, the clamping port 112 of the connecting tube 1 is brought into contact with the ocular tissue at the injection site, and force is applied to the ocular tissue at the injection site, so that the conjunctival tissue clamped by the clamping port 112 of the connecting tube 1 forms a protrusion 32 within the injection end 11 of the connecting tube 1, and the tip of the needle portion 3 is pushed into the target ocular tissue at the injection site.

[0170] Step 7: Using the same hand or a different hand, the pusher of the syringe 4 is pressed to inject and administer the drug so that the drug reaches the target tissue at the administration site.

[0171] During the injection, the needle 3 was moved toward the syringe 4, and the injection status was recorded, including reflux, diffusion to the ocular surface, subconjunctival residue, diffusion, bleeding, or hyperemia. During the injection, the needle tip was observed to ensure it did not deviate from the injection site or scratch the ocular surface. The rabbits were then sacrificed, the eyeballs dissected, and planar samples of the fundus tissue were prepared. The distribution of the ICG solution in the suprachoroidal space was recorded by photography.

[0172] Test results: Observation showed that the needle 3 did not move toward the syringe 4, the injected drug did not reflux or spread to the ocular surface, no conjunctival residue, bleeding, or congestion was observed, the injection site did not slip, and there was no damage to the ocular surface near the injection site. The results of the fundus tissue section are shown in Figure 27. ICG was transfected into almost all of the fundus tissue, and the stained fundus tissue was dark green. According to the above experimental results, the injection was successful.

[0173] Test Example 5 The differences from Test Example 4 are that the inner diameter of the clamping port 112 of the connecting tube 1 is 1.0 mm, the blade length is 450±50 μm, and the exposed length of the tip of the needle part 3 is 0.7 mm.

[0174] Test results: Observation showed that the needle 3 did not move toward the syringe 4, there was no backflow or diffusion of the drug injection onto the ocular surface, no conjunctival residue, bleeding, or congestion was observed, the injection site did not slip, and there was no damage to the ocular surface near the injection site. The results of the fundus tissue section are shown in Figure 28. ICG was transfected into almost all of the fundus tissue, and the stained fundus tissue was green. According to the above experimental results, the injection was successful.

[0175] Test Example 6 The differences from Test Example 4 are that the inner diameter of the clamping port 112 of the connecting tube 1 is 3.0 mm, the blade length is 450±50 μm, and the exposed length of the tip of the needle part 3 is 0.7 mm.

[0176] Test results: Observation showed that the needle 3 did not move toward the syringe 4, the injected drug did not reflux or spread to the ocular surface, there was no conjunctival residue, bleeding, or congestion, the injection site did not slip, and there was no damage to the ocular surface near the injection site. The results of the fundus tissue section are shown in Figure 29. The area of ​​the fundus tissue transfected with ICG was more than 4 / 5, and the stained fundus tissue was dark green. According to the above experimental results, the injection was successful.

[0177] Test Example 7 The difference from Test Example 4 is that the syringe sleeve, syringe, and injection device formed in Example 2 are used, and the blade length is 500±50 μm.

[0178] Injection method: According to the needs, a needle 3 with a needle base length of 6.8 mm is selected and attached to the syringe 4. The exposed length of the tip of the needle 3 is 0.8 mm. The operator places his / her finger on the positioning structure 24 to fix the finger to the syringe sleeve, holds the syringe sleeve with the same hand, and waits for the operation.

[0179] Test results: Observation showed that the needle 3 did not move toward the syringe 4, there was no reflux or diffusion of the injected drug onto the ocular surface, and no conjunctival residue, bleeding, or congestion was observed. The results of the fundus tissue section are shown in Figure 30. ICG was transfected into almost all of the fundus tissue, and the stained fundus tissue was dark green. The injection site did not slip, and there was no damage to the ocular surface near the injection site. The above experimental results showed that the injection was successful.

[0180] Test Example 8 The difference from Test Example 4 is that the syringe sleeve, syringe, and injection device formed in Example 6 were used, and the blade length was 350±50 μm. Injection method:

[0181] First step: Place the syringe 4 into the positioning tube 2 from the top end of the positioning tube 2, and rotate the syringe 4 until the syringe barrel flange 41 moves into the mounting groove 21, completing the fixing of the syringe 4 and the positioning tube 2 to each other.

[0182] Second step: The drug aspirating needle is attached to the distal end of the syringe barrel of the syringe 4 to complete the drug aspirating process.

[0183] Third step: A needle 3 having a needle base length of 6.7 mm is selected, and the needle 3 is placed in the connecting tube 1.

[0184] Fourth step: Remove the drug aspiration needle and attach the connecting barrel 1 with the needle 3 to the distal end of the syringe barrel.

[0185] Step 5: Rotate the connecting tube 1 forward, moving the connecting tube 1 with the attached needle 3 toward the distal end of the syringe barrel, so that the tip of the needle 3 moves toward the injection end of the connecting tube 1. Adjust the overall length of the connection between the connecting tube 1 and the positioning tube 2 to adjust the length of the tip of the needle 3 exposed from the connecting tube 1. Finally, the connecting tube 1 abuts and cannot retract, and the exposed length of the tip of the needle 3 reaches the set length of 0.7 mm.

[0186] Step 6: Use a measuring device to measure the eye to be injected and confirm the injection site.

[0187] Seventh step: hold the syringe sleeve by hand and make the clamping port 112 of the connecting tube 1 perpendicular to the surface of the ocular tissue at the injection site.

[0188] Step 8: Through cooperation between the syringe 4 and the syringe sleeve of the ophthalmic injection device, the clamping port 112 of the connecting tube 1 is brought into contact with the ocular tissue at the injection site, and force is applied to the ocular tissue at the injection site, so that the conjunctival tissue clamped by the clamping port 112 of the connecting tube 1 forms a protrusion 32 within the injection end 11 of the connecting tube 1, and the tip of the needle portion 3 is pushed into the target ocular tissue at the injection site.

[0189] Step 9: Using the same hand or a different hand, the pusher of the syringe 4 is pressed to inject and administer the drug so that the drug reaches the target tissue at the administration site.

[0190] Test results: Observation showed that the needle 3 did not move toward the syringe 4, there was no backflow or diffusion of the injected drug onto the ocular surface, no conjunctival residue, bleeding, or congestion was observed, the injection site did not slip, and there was no damage to the ocular surface near the injection site. The results of the fundus tissue section are shown in Figure 31. ICG was transfected into almost all of the fundus tissue, and the stained fundus tissue was dark green. The above experimental results showed that the injection was successful.

[0191] Test Example 9 Test Example 4 employs the injection device and the injection method.

[0192] Test animal: 1 rhesus monkey Injection frequency: left eye / once. The day of administration to the animals is defined as the first day of the test. Injection reagent: rAAV-anti-VEGF Dosage and concentration: Dosage: 1.0 x 10 12 vg / eye, administration concentration: 1.0 × 10 13 vg / ml Dosage volume: 100 ul / eye Administration method: After anesthetizing the rhesus monkey, disinfect the eye to be injected with povidone-iodine solution. Under a surgical microscope, use a lid speculum to open the eyelid and expose the operating site. In Test Example 4, use the injection device described above. Select needle 3 with a base length of 6.7 mm and adjust the exposed tip length of needle 3 to 0.7 mm. Select the supratemporal area of ​​the eyeball behind the flat part of the vitreous body, puncture the sclera, and advance the needle to complete the injection of the drug into the suprachoroidal space. After completion of the procedure, instill ofloxacin ophthalmic ointment into both eyes to moisten the cornea and prevent infection. During the injection, the injection status is recorded, including whether the needle 3 moves toward the syringe 4, reflux of the drug solution, diffusion onto the ocular surface, subconjunctival residue, diffusion, bleeding, or congestion. During the injection, the needle tip is observed to see if it moves away from the injection site or if the ocular surface is scratched.

[0193] After 13 weeks of administration, the rhesus monkeys were dissected and key ocular tissues, including the aqueous humor, vitreous humor, iris / ciliary body, retina, choroid, and sclera, from the injected eyes were collected and tested by qPCR to examine the concentration distribution of the target gene in the ocular tissues. Among them,

[0194] Quantitation limit: target gene (DNA) concentration = 2.0 x 10 4 vg / ml Detection limit for tissue samples: 2.5 x 10 4 vg / g organization Detection limit for aqueous humor and vitreous samples: 1.25 x 10 3 vg / ml aqueous humor and vitreous samples The test results are as follows: Observation of the injection status showed that the needle 3 did not move toward the syringe 4, there was no backflow or diffusion of the injected drug onto the ocular surface, no residue, bleeding, or congestion was observed in the conjunctiva, the injection site did not slip, and there was no injury to the ocular surface near the injection site.

[0195] According to the results of detecting the concentration distribution of the target gene in the ocular tissues (specifically as shown in Table 3), the target gene was mainly distributed in the sclera and choroid, which is consistent with the characteristics of injection into the suprachoroidal space.

[0196] [Table 3]

[0197] Based on the above observations of the injection status and the concentration distribution of the target gene in the ocular tissue, the injection into the suprachoroidal space was successful in this test.

[0198] The above description is merely a preferred embodiment of the present application and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made without departing from the spirit and principles of the present application should fall within the scope of protection of the present application. For specific components arranged in specific directions or positions shown in the above schematic diagrams and / or examples, the arrangement of the components can be adjusted accordingly. Similarly, when methods or steps are described herein, the order of specific methods and / or steps can be adjusted. While the above embodiments have been particularly illustrated and described, it will be understood that different changes in form and details are possible.

[0199] Although the devices and methods described herein have been described and illustrated as being provided for delivering drugs to the suprachoroidal space, in other examples, the devices and methods described herein may be suitable for delivering any suitable therapeutic substance to any portion of the eye, such as the cornea, conjunctiva, retinal region, or vitreous body, etc. In other examples, any of the devices and methods described herein may be used to deliver any suitable therapeutic substance to any desired target tissue of the eye. [Explanation of symbols]

[0200] 1 Connecting tube 11 Injection end 111 Circular boss 112 Clamping port 113 Chamber 114 Annular end face 115 Contraction Stage 12 Connection end 13 Engagement groove 2 Positioning tube 21 Mounting groove 22 Rock Tag 23 Flange mounting base 24 Position regulation structure 25 Position control flange 26 Arc-shaped protrusion 3 Needle 31 Convex rib 32 Protrusion 33 Needle holder 34 Needle base 4 syringe 41 Syringe barrel flange 5. Lure Interface

Claims

1. A syringe sleeve that fits over the outside of the syringe, a positioning tube for fixing to the syringe barrel flange; a connecting tube including a connecting end and an injection end, wherein the connecting end is used to connect to the positioning tube, and the injection end is used to position the portion of the tip of the needle that is exposed from the connecting tube.

2. 2. The syringe sleeve according to claim 1, wherein when the connecting tube and the positioning tube are connected, the overall length of the connecting tube and the positioning tube can be changed by the connection.

3. The aforementioned 3. The syringe sleeve according to claim 1, wherein an annular boss is provided on the inside of the injection end, and the annular boss is used to engage a needle holder of a needle part and to position the needle part.

4. The syringe sleeve according to claim 3, characterized in that a convex rib is provided around the top end of the needle holder of the needle portion, and the convex rib is engaged with the annular boss and is used to limit the length of the needle portion exposed from the injection end by the annular boss.

5. 4. The syringe sleeve according to claim 3, wherein the annular boss locks the needle holder of the needle when the length of the injection end exposed from the connecting tube of the tip of the needle is adjusted.

6. 3. The syringe sleeve according to claim 1, wherein the injection end is provided with a contraction step, which is used to lock a needle holder of the needle part and to restrict the position of the needle part.

7. The syringe sleeve according to any one of claims 1 to 6, characterized in that a clamping port is provided at an end of the injection end for pressing against ocular tissue at an injection target site, the clamping port having an annular end surface, and the annular end surface having a minimum inner diameter of 1 mm to 3 mm.

8. The syringe sleeve according to any one of claims 1 to 7, characterized in that the connecting end and the positioning tube are connected by a screw connection or a snap-fit ​​connection.

9. The syringe sleeve of claim 8, characterized in that the connecting end is used to connect with the positioning tube from one end of the positioning tube facing the needle portion, or the connecting end is placed within the positioning tube from one end of the positioning tube facing the tail portion of the syringe pusher and used to connect with the positioning tube.

10. The syringe sleeve according to claim 9, characterized in that the connecting end is provided with a male thread, the positioning tube is provided with a female thread, the connecting end is connected to the positioning tube by rotation, and the overall length of the connecting tube and the positioning tube is adjusted by rotation.

11. The syringe sleeve according to claim 9, characterized in that the connecting barrel is placed in the positioning barrel from one end of the positioning barrel facing the tail portion of the syringe pusher and connected thereto, and after the syringe is attached, the syringe barrel flange is abutted against the connecting end to limit the distance that the connecting end can be rotated back within the positioning barrel.

12. The syringe sleeve according to any one of claims 1 to 11, characterized in that an inner wall of the connecting tube is provided with a one-stage engaging groove along the axial direction, the engaging groove being used for engaging with the outside of the syringe barrel or the outside of the needle holder of the needle part, and the syringe can move along the axial direction of the connecting tube under the guidance of the engaging groove.

13. The syringe sleeve according to claim 12, wherein a protrusion is provided on the outer side of the needle holder of the needle portion, and the shape and size of the protrusion match the cross section of the engagement groove.

14. The syringe sleeve according to any one of claims 1 to 13, characterized in that the positioning cylinder is provided with an attachment groove for attaching the syringe barrel flange, and the syringe barrel flange is used to be engaged with the attachment groove by rotation.

15. 15. The syringe sleeve of claim 14, wherein the positioning barrel is provided with a flange mount and a lock tag, the flange mount is used to support one side of the syringe barrel flange, the lock tag is used to lock the other side of the syringe barrel flange, and a gap between the lock tag and the flange mount forms the mounting groove.

16. 16. The syringe sleeve according to claim 15, wherein an arc-shaped protrusion structure is provided on the top of the flange mount or the bottom of the locking tag, and the arc-shaped protrusion structure is used to lock one side of the syringe barrel flange.

17. A syringe sleeve as described in any one of claims 1 to 16, characterized in that the injection end restricts the position of the part of the tip of the needle portion exposed from the connecting tube, and the syringe locks the needle holder of the needle portion.

18. The syringe sleeve according to any one of claims 1 to 17, characterized in that a position control structure for fixing an operator's finger is further provided on the outside of the positioning tube, and the position control structure is a protrusion, a notch, or a ring structure.

19. fitted onto the outside of the syringe, a positioning tube for fixing to the syringe barrel flange; a connecting tube including a connecting end and an injection end, wherein the connecting end is used to connect to the positioning tube, and the injection end is connected to the needle portion by a needle holder of the needle portion within the connecting end, and the position of the portion of the tip of the needle portion exposed from the injection end is controlled.

20. 20. The needle sleeve of claim 19, wherein when the injection tip and the needle holder are connected, the overall length of the injection tip and the needle holder can be changed by the connection.

21. The sleeve with needle portion described in claim 19 or 20, characterized in that an annular boss is provided on the inside of the injection end of the connecting tube, and the annular boss is used to engage a needle holder of the needle portion and to position the needle portion.

22. The sleeve with needle portion according to claim 19 or 20, characterized in that the injection end of the connecting tube is provided with a contraction step, which is used to engage the needle holder of the needle portion and thereby regulate the position of the needle portion.

23. A sleeve with a needle portion as described in any one of claims 19 to 22, characterized in that when the position of the part of the tip of the needle portion exposed from the injection end is restricted at the injection end, the syringe locks the needle holder.

24. A sleeve with a needle portion described in any one of claims 19 to 23, characterized in that a luer interface is provided between one end of the positioning tube facing the connecting tube and the needle holder of the needle portion, and the needle holder of the needle portion and the syringe located in the positioning tube are quickly connected to form an integrated structure.

25. The sleeve with a needle portion according to any one of claims 19 to 23, characterized in that the connecting end of the connecting tube is connected to the needle holder of the needle portion, and then coupled to the bottom end of the positioning tube to which the syringe barrel is fixedly connected, and the needle holder and the syringe located in the positioning tube are quickly connected to form an integrated structure.

26. An injection assembly comprising: a syringe sleeve according to any one of claims 1 to 18; or a sleeve with a needle according to any one of claims 19 to 25; and a syringe, wherein the syringe is provided within the connecting tube and the positioning tube; a syringe barrel flange of the syringe engages with a mounting groove of the positioning tube; and a length of the needle of the syringe exposed from the connecting tube is adjusted by the connection between the connecting tube and the positioning tube or the connection between the connecting tube and a needle holder of the needle.

27. The injection assembly according to claim 26, characterized in that when the length of the needle portion of the syringe exposed from the connecting barrel is adjusted by connecting the connecting barrel with the positioning barrel or connecting the connecting barrel with the needle holder of the needle portion, the syringe located in the positioning barrel can be quickly connected to the needle portion to form an integrated structure and lock the needle holder of the needle portion.

28. 28. An injection assembly according to claim 26 or 27, wherein the syringe is a pre-filled syringe.

29. The method for using the injection assembly according to any one of claims 26 to 28, characterized in that the syringe locks the needle portion by coupling the positioning barrel and the connecting barrel.

30. A method of using an injection assembly according to any one of claims 26 to 28, characterized in that the tip of the needle portion does not move in accordance with the movement of the pusher within the syringe by connecting the positioning tube and the connecting tube.

31. 29. A method for treating an ocular disease, comprising using the injection assembly of any one of claims 26 to 28 to deliver a pharmaceutically active substance to ocular tissue of a subject in need of treatment, wherein the pharmaceutically active substance is at least one selected from an antibody, an antiviral agent, a chemotherapeutic agent, an analgesic agent, an anesthetic agent, an aptamer, an antihistamine, an anti-inflammatory agent, an anti-tumor agent, and a recombinant adeno-associated virus-vectored gene therapy drug.

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