Long-acting slow-release drug delivery device used between natural crystalline lens and iris of human eyeball

Abstract

The invention relates to the related technical field of medical instruments, in particular to a long-acting slow-release drug delivery device used between a natural crystalline lens and an iris of a human eyeball, the long-acting slow-release drug delivery device comprises a needle cylinder, an outer needle head, a push rod, an inner needle tube and the eyeball, the outer needle head is installed on the left side of the needle cylinder, the push rod is installed in the needle cylinder, and the inner needle tube is installed at one end of the right side of the push rod; the inner needle tube enters an eyeball through extrusion of the push rod, the surface of one side of the inner needle tube is attached to the surface of one side of the piston, and the U-shaped medicine carrying elastic body is placed in the needle cylinder; the magnetic suction plate provides suction force for the suction rod, so that the suction rod with suction force is connected with the inner needle tube to adsorb the U-shaped medicine carrying elastic body; one end of the inner needle tube penetrates through the outer surface of the outer needle head, and the outer needle head penetrates through the outer surface of an eyeball and enters a space between a natural crystalline lens and an iris of the eyeball, so that the U-shaped medicine carrying elastomer enters the eyeball.

Description

Technical Field

[0001] The present invention relates to the technical field related to medical devices, and in particular to a long-acting sustained-release drug delivery device used between the natural lens and iris of a human eyeball. Background Art

[0002] As the aging of the population in my country accelerates, the number of people suffering from cataracts continues to increase. According to statistics, the incidence of cataracts in people aged 60 to 89 in my country is 80%, while the incidence of cataracts in people over 90 years old is more than 90%. At the same time, in recent years, due to unhealthy diet, diabetes, high myopia and other reasons, the population suffering from cataracts has also shown a trend of younger and younger age. Cataract phacoemulsification + intraocular lens implantation is currently the world's most recognized and mature way to treat cataracts. Cataracts are equivalent to a built-in lens "lens" in our eyes that has become cloudy, so the surgery is to use ultrasonic technology to crush and remove the cloudy lens and peel off a layer of membrane. But if the intraocular lens is not implanted, it is like a camera without a lens, unable to focus and form a clear visual image.

[0003] Therefore, each patient needs to implant an artificial lens, which is placed in the original physiological position of our cataract to focus light. Since a large number of elderly patients have combined symptoms of cataract + glaucoma, they still need to detect intraocular pressure in time after implanting the artificial lens, and release relevant symptomatic drugs in time for treatment. The present invention is based on the concept of detection + constant-rate drug release and is an integrated detection and treatment implantable micro-ophthalmic drug device (implanted in front of an artificial or naturally existing eye lens).

[0004] First, surgery is required to implant the device, which will cause a large implant wound and is dangerous. Our new invention achieves minimally invasive implantation through a foldable, U-shaped drug-loaded elastomer. Second, common treatments require repeated injections or implants of drugs, which can easily cause damage to the patient's research; Third, the implanted device needs to be removed later, which requires a second surgery, which is very inconvenient and prone to infection; Fourthly, implanting more than two drugs at a time can achieve synergistic treatment with more obvious effects (can achieve higher therapeutic effects with lower drug dosage), which will further reduce the damage of multiple minimally invasive drug delivery and implantation, and is beneficial to protecting the patient's eye tissue; Fifth, the device of the present invention has the dual functions of detection (alloy metal crossbeam of U-shaped drug-carrying elastomer) and drug release (U-shaped drug-carrying elastomer, composed of polymer), and a single minimally invasive implant can solve the problem that requires two or even multiple surgeries to solve; Sixth, the U-shaped drug carrier can be folded and implanted through reversible magnetic adsorption. After the treatment is completed, the U-shaped body can be folded and implanted again.

[0005] In view of the above situation, in order to overcome the above technical problems, the present invention designs a long-acting sustained-release drug delivery device for use between the natural lens and iris of the human eyeball, which solves the above technical problems. Summary of the invention

[0006] The technical purpose to be achieved by the present invention is: a long-acting sustained-release drug delivery device for use between the natural lens and iris of the human eye, which has a U-shaped drug-loaded elastomer and a high polymer (levorotatory PLLA) reinforcement strip, which can be deformed (compressed from an elliptical shape into a long strip and stored in a duckbill implanter), and can be minimally invasively recovered using the implanter matched with the present invention without the need for a large incision.

[0007] In order to achieve the above technical objectives, the present invention provides the following technical solutions: The present invention provides a long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eye, comprising a syringe, an outer needle, a push rod, an inner needle tube and an eyeball, wherein the outer needle is installed on the left side of the syringe, the push rod is installed inside the syringe, the inner needle tube is installed on the right end of the push rod, the inner needle tube enters the eyeball through the squeezing of the push rod, one side surface of the inner needle tube fits with one side surface of the piston, and the U-shaped drug-loaded elastomer is placed inside the syringe; the magnetic suction plate provides suction to the suction rod, so that the suction rod with suction is connected to the inner needle tube to adsorb the U-shaped drug-loaded elastomer; one end of the inner needle tube penetrates the outer surface of the outer needle, the outer needle penetrates the outer surface of the eyeball and enters between the natural lens and iris of the human eyeball, thereby completing the entry of the U-shaped drug-loaded elastomer into the eyeball.

[0008] Preferably, the cross-sectional shape of the syringe is rectangular, handles are installed on both sides of the outside of the syringe, and a filling port is installed on the right side of the syringe. The filling port is used to open from the middle to both sides, and the filling port is convenient for replacing the inner needle tube to enter the eyeball.

[0009] Preferably, the cross-sectional shape of the push rod is a cross, and the cross shape of the push rod corresponds to the corner of the syringe rectangle, a push plate for pushing the push rod is installed on the left side of the push rod, a piston is installed on the right side of the push rod, the shape of the piston is the same as the size and shape of the inner surface of the syringe, a magnetic suction plate for providing suction to the parts is provided in the middle of the piston, a suction rod is installed on the magnetic suction plate, and the right end of the suction rod is the inner needle tube.

[0010] Preferably, the magnetic suction plate generates a certain suction force by being energized, so as to realize the function of magnetic adsorption and folding of the alloy metal beam of the U-shaped drug-carrying elastomer.

[0011] Preferably, the inner needle tube is connected to the suction rod, and the inner needle tube transmits the suction force of the suction rod to the inner needle tube through the magnetic suction plate to generate suction.

[0012] Preferably, a U-shaped drug-loaded elastomer is installed on the inner needle tube, the shape of the ammunition body is elliptical, the U-shaped drug-loaded elastomer is an alloy composed of magnesium, iron and zinc, and the U-shaped drug-loaded elastomer is adsorbed to the inner needle tube through two foldings, the first folding of the U-shaped drug-loaded elastomer is folded in half, and the second folding of the U-shaped drug-loaded elastomer is folded along 1 / 4 of the left and right sides.

[0013] And the main innovations of the present invention are as follows: 1) The benchmark product is a diagnostic device for detecting intraocular pressure. Ours is a pressure-sensitive controlled-release material (with a metal spiral coil inside). If the intraocular pressure rises, the external app can scan the increase in magnetic force (the alloy metal crossbeam of the U-shaped drug-carrying elastomer has a spiral structure of micro-coils inside, which can emit specific electromagnetic signals). At the same time, the drug will be automatically released. It has both: automatic diagnosis and treatment in one operation (glaucoma intraocular pressure detection, drug release).

[0014] 2) U-shaped drug-loaded elastomeric device, containing a high polymer reinforcement strip, which can be deformed (compressed from an elliptical shape into a long strip and stored in a duckbill implanter) and can be minimally invasively retrieved with an implanter without the need for a large incision.

[0015] 3) On a daily basis, the drug is released at a constant rate through an osmotic pump. If the intraocular pressure increases, it will promote the penetration rate, accelerate the release of the drug, and provide dynamic feedback.

[0016] 4) When recovering, there is no need to cut open the eyeball. Just use the duckbill implanter to grab the signal sensor, compress it a second time, enter the implanter and pull out the eyeball. The incision is 1 / 3-1 / 5 of the size of an ordinary ophthalmic surgical window.

[0017] The beneficial effects of the present invention are as follows: 1. Since the U-shaped drug-loaded elastomer is folded in the outer needle, it will only deform and reset after the lens is injected, so that a larger device can be implanted with a smaller wound, achieving the effect of reducing the wound.

[0018] 2. The drug gel is a degradable polymer material. It is a sustained-release preparation composed of a polymer and one or more drugs. It has the function of sustained release for 1-2 years and is very convenient without the need for repeated injections or multiple ophthalmic implant surgeries.

[0019] 3. Since the drug-releasing pores and high molecular polymers (U-shaped drug-loaded elastomers) are both degradable materials, they can slowly degrade into substances that can be absorbed by the human body after 4 years. There is no need for a second operation to remove them, which can reduce the number of operations and risks.

[0020] 4. At the same time, a series of operations such as magnetic deformation, contraction, depolymerization, and resetting are performed on the U-shaped drug-loaded skeleton through a magnetic rod, so that the implantation channel can be directly left inside the eyeball without using the hand to hold and grasp the external needle, thereby preventing infection and improving efficiency.

[0021] 5. The above structural module can be used for symptomatic treatment of small molecule drugs such as monoclonal antibodies for the treatment of glaucoma and presbyopia. After 2 years, the drug release is completed and the U-shaped drug-loaded elastomer can be replaced with a new biodegradable polymer U-shaped drug-loaded elastomer to fill the module for minimally invasive drug supplementation.

[0022] 6. For patients who also suffer from diseases such as glaucoma, a pressure-sensitive drug-releasing layer (such as bimatoprost nanocrystal suspension) can be simultaneously coated on the outside of the balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] The above and other aspects of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 It is an overall schematic diagram of the syringe of the present invention; Figure 2 is a schematic diagram of the outer needle of the present invention entering the eyeball; Figure 3 is a cross-sectional view of the syringe of the present invention; Figure 4 It is a schematic diagram of the U-shaped drug-carrying elastomer of the present invention wrapped in the inner needle tube; Figure 5 It is a schematic diagram of the U-shaped drug-carrying elastic body of the present invention unfolded in the inner needle tube; Figure 6 It is a cross-sectional view of the U-shaped drug-carrying elastomer of the present invention.

[0025] In the figure: 1. syringe; 11. handle; 12. filling port; 2. outer needle; 3. push rod; 31. push plate; 32. piston; 33. magnetic suction plate; 34. suction rod; 4. inner needle tube; 41. U-shaped drug-carrying elastomer; 5. eyeball. DETAILED DESCRIPTION

[0026] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0027] like Figure 1 , 2 , 3, 4, 5 and 6, the present invention provides a long-acting sustained-release drug delivery device for the natural lens and iris of a human eyeball 5, comprising a syringe 1, an outer needle 2, a push rod 3, an inner needle tube 4 and an eyeball 5, the outer needle 2 is installed on the left side of the syringe 1, the push rod 3 is installed inside the syringe 1, the inner needle tube 4 is installed on the right end of the push rod 3, the inner needle tube 4 enters the eyeball 5 through the extrusion of the push rod 3, and one side surface of the inner needle tube 4 is in contact with the piston 32 The surfaces on one side are in contact with each other, and the U-shaped drug-carrying elastomer 41 is placed inside the syringe 1; the magnetic suction plate 33 provides suction to the suction rod 34, so that the suction rod 34 with suction is connected to the inner needle tube 4 to adsorb the U-shaped drug-carrying elastomer 41; one end of the inner needle tube 4 penetrates the outer surface of the outer needle head 2, and the outer needle head 2 penetrates the outer surface of the eyeball 5 and enters between the natural lens and iris of the human eyeball 5, thereby completing the entry of the U-shaped drug-carrying elastomer 41 into the eyeball 5.

[0028] The device accurately delivers the drug to the target position between the natural lens and the iris of the human eyeball 5 through the inner needle tube 4, which helps to ensure that the drug directly acts on the part that needs to be treated and improves the effect of the U-shaped drug elastic entry. And the U-shaped drug elastic can easily enter the eyeball 5, so as to achieve the continuous and stable release of the drug and achieve the purpose of rapid treatment. By directly releasing the drug inside the eyeball 5, the impact of the drug on other parts can be reduced, the systemic side effects can be reduced, and a safer treatment method can be provided. And the treatment effect is more obvious and rapid, and the efficacy is improved. The design of the magnetic suction plate 33 and the suction rod 34 improves the adsorption and transmission efficiency of the U-shaped drug-loaded elastomer 41 in the drug device. This design ensures that the drug enters smoothly and remains in the target area. The design of the outer needle 2 and the inner needle tube 4 enables the drug to enter the eyeball 5 through a smaller puncture, with less trauma and relatively less damage to the eyeball 5, which helps the patient's comfort and postoperative recovery. The long-acting sustained-release drug delivery device is not only suitable for common eye diseases, but also can be expanded to a variety of ophthalmic treatments that require slow release of drugs, and adapts to different types of eye disease treatment needs.

[0029] like Figure 1 , 2As shown in FIG. 3 , the cross-sectional shape of the syringe 1 is rectangular, and handles 11 are installed on both sides of the outside of the syringe 1. A filling port 12 is installed on the right side of the syringe 1. The filling port 12 is used to open from the middle to both sides, and the filling port 12 is convenient for replacing the inner needle tube 4 to enter the eyeball 5.

[0030] The design of the rectangular cross section makes the syringe 1 more stable and avoids rotation or tilting during use. Compared with the circular cross section, the rectangular shape is more conducive to the grip of the human palm, so that the operator can control the syringe 1 more firmly. At the same time, the design of the pull handle 11 makes the operation of the syringe 1 more convenient, especially when fine control is required, the operator can easily pull or push the syringe 1, reducing the burden on the hands during operation. The pull handle 11 enables the operator to more accurately control the drug delivery process during operation, avoid unnecessary drug waste, and more effectively deliver the drug to the desired position when the drug capacity in the syringe 1 is limited. The filling port 12 can be easily opened to allow the rapid replacement of the inner needle tube 4. The user can easily replace the inner needle tube 4 as needed, and can replace the appropriate inner needle tube 4 in time. The design of the filling port 12 can make the loading and storage process of the drug in the syringe 1 more convenient, and avoid unnecessary leakage and waste, and the rapid replacement function of the inner needle tube 4 enhances the adaptability of the device, which is suitable for different patients and different treatment needs.

[0031] like Figure 3 As shown, the cross-sectional shape of the push rod 3 is a cross, and the cross shape of the push rod 3 corresponds to the corner of the rectangle of the syringe 1, a push plate 31 for pushing the push rod 3 is installed on the left side of the push rod 3, and a piston 32 is installed on the right side of the push rod 3, and the shape of the piston 32 is the same as the size and shape of the inner surface of the syringe 1, and a magnetic suction plate 33 for providing suction to the parts is provided in the middle of the piston 32, and a suction rod 34 is installed on the magnetic suction plate 33, and the right end of the suction rod 34 is the inner needle tube 4.

[0032] The setting of the push plate 31 makes it smoother to push the push rod 3, and the operator can operate comfortably, avoiding unnecessary fatigue. Through the design of the magnetic suction plate 33 and the suction rod 34, the U-shaped drug-carrying elastomer 41 can be quickly and effectively adsorbed and delivered to the target area, avoiding drug waste and improving the treatment effect. By providing a more stable delivery effect, the patient can obtain a better treatment experience and effect during the treatment process, and the treatment process is safer.

[0033] like Figure 3 , 4As shown in Figure 5, the magnetic suction plate 33 generates a certain suction force by being energized to realize the function of magnetic adsorption and folding of the alloy metal beam of the U-shaped drug-carrying elastomer 41, so that the magnetic suction plate 33 can successfully transfer the suction force to the inner needle tube 4 and the suction rod 34, so that the U-shaped drug elastic can be tightly adsorbed to the inner needle tube 4.

[0034] like Figure 3 , 4 As shown in FIG. 5 , the inner needle tube 4 is connected to the suction rod 34 , and the inner needle tube 4 transmits the suction force of the suction rod 34 to the inner needle tube 4 through the magnetic suction plate 33 , thereby generating suction.

[0035] Through the transmission of magnetic suction, the inner needle tube 4 can accurately absorb and transport the U-shaped drug-carrying elastic body 41, thereby improving the accuracy and efficiency of the delivery of the U-shaped drug-carrying elastic body 41. The suction force can be adjusted as needed to adapt to the characteristics of different drugs and individual differences of patients, thereby ensuring the best treatment effect and improving the convenience and reliability of the treatment process. While ensuring the accurate delivery of the U-shaped drug-carrying elastic body 41, it avoids overdose or misdelivery of the drug, thereby improving the safety and effect of the treatment.

[0036] like Figure 4 , 5 As shown in Figure 6, a U-shaped drug-carrying elastomer 41 is installed on the inner needle tube 4, and the shape of the ammunition body is elliptical. The U-shaped drug-carrying elastomer 41 is an alloy composed of magnesium, iron and zinc, and the U-shaped drug-carrying elastomer 41 is adsorbed to the inner needle tube 4 by folding twice. The first folding of the U-shaped drug-carrying elastomer 41 is folded in half, and the second folding of the U-shaped drug-carrying elastomer 41 is folded along 1 / 4 of the left and right sides.

[0037] Through the unique folding design and material selection, the U-shaped drug-loaded elastomer 41 can provide long-term and stable drug release, thereby improving the effectiveness of treatment. The use of magnesium, iron and zinc alloys improves biocompatibility and corrosion resistance, and ensures the safety and durability of the drug elastomer. The folding structure not only makes it easier for the U-shaped drug-loaded elastomer 41 to enter the eyeball 5, but also ensures the uniform release of the drug during treatment, avoiding uneven release of the U-shaped drug-loaded elastomer 41. This design is suitable for sustained-release treatment of a variety of eye diseases, and can flexibly adjust the type and dosage of drugs according to different treatment needs.

[0038] Manufacturing process, prescription ratio: The U-shaped drug-loaded elastomer 41 (polymer sustained-release material) may be made of: modified high-polymerization degree collagen + PLLA (L-lactic acid); the polymer material may also be modified collagen (high polymerization degree) + SAIB; the polymer material may also be modified collagen (high polymerization degree) + SAIB + PLLA; the polymer material may also be modified collagen (high polymerization degree) + SAIB + PLLA + HEMA; the degradable polymer may also be made of the following materials: biodegradable polylactic acid (PLA), polybutylene terephthalate adipate (PBAT), polyhydroxyalkanoate (PHA), polybutylene succinate (PBS), polycaprolactone (PCL), polyvinyl alcohol (PVA), etc., or a mixture of several proportions.

[0039] The U-shaped drug-loaded elastomer 41 (polymer sustained-release material) is divided into three parts: a drug-releasing channel 11, a polymer sustained-release material 12, and a clamping ring combined with a metal magnetic beam.

[0040] The U-shaped implant (metal beam part) can be folded by magnetic adsorption: it is stored in the needle of the syringe in a compressed and folded state before use. The material is made of magnetically sensitive + elastic, foldable metal material, and has a built-in spiral coil.

[0041] The U-shaped drug-loaded elastomer 41 (polymer sustained-release material) has a PLLA+HEMA material with a semi-permeable membrane pore of 0.03-0.2um; the inner layer is made of modified high-polymerization collagen + PLLA material; an osmotic pressure promoting regulator, such as PEO, modified cellulose (different molecular weights: HPMC-k15M, K100M, K200M), etc., is applied between the inner and outer membranes. After water penetrates, it expands and squeezes the inner capsule bag, promoting the drug to gradually flow from the drug release hole to the internal tissue of the eye.

[0042] If the pressure inside the eyeball 5 increases, the molecular osmotic pressure between the double-layer membrane material will be superimposed, further accelerating the drug release rate during the period of increased intraocular pressure.

[0043] The magnetically adsorbable and foldable U-shaped implant (metal crossbar part) is the filling port for surgical removal or re-implantation. It is composed of iron-magnesium-zinc alloy (2.8%: 51%: 46.2%) + PLLA material, and is tightly connected to the U-shaped drug-carrying elastomer 41 (. When refilling the drug, it is magnetically positioned with the drug-filled needle. The iron element in the alloy provides the magnetic source. The magnetic targeting positioning device at the front of the needle can accurately locate the needle and the center of the drug release hole.

[0044] The drug release process relies on the polymer U-shaped drug-loaded elastomer 41 implant, which can quickly engage with the metal beam part. After the polymer U-shaped implant is released in the body, it is taken out of the eyeball, the empty polymer U-shaped implant and the metal beam are separated, and then a new polymer U-shaped implant is taken again, quickly engaged with the metal beam part, and then magnetically folded and transplanted into the eyeball in the same way. Drugs can be supplemented for the next drug release cycle (1-2 years).

[0045] Manufacturing process: (1) According to the mold drawing, design and manufacture a dedicated implant device syringe 1, an outer needle 2, a push rod 3, an inner needle tube 4 and a U-shaped drug-carrying elastomer 41.

[0046] (2) The double-layer U-shaped drug-loaded elastomer 41, namely the inner skeleton capsule and the outer skeleton capsule (a blow-molded sterile, hollow, double-layer implant capsule; it is in a compressed state before implantation and has not yet been unfolded, and is flat. After implantation, it expands slightly to form a lentil-like or cylindrical state. After the drug is released, it can be taken out). The inner and outer skeleton capsules are evenly coated and adhered with osmotic pressure enhancers such as PEO and modified cellulose (here, 27ug of bematoprost nanocrystal suspension is added to the adhesion layer, which can sustain the effective dose for 12 months; depending on the specifications, 78ug of bematoprost nanocrystal suspension can also be added, which can sustain the effective dose for 24 months). When the intraocular pressure of the patient increases, the drug will be released faster from the nanopores formed by the porogen due to pressure. Since the particle size distribution of the bimatoprost nanocrystal suspension is controlled to D90=260-578nm, which is slightly higher than the nanopore size of the porogen in the pressure-sensitive layer, the drug will not be released suddenly, but will be gradually compressed and eroded to form bimatoprost nanocrystals with smaller particle sizes, which will gradually enter the eyeball 5 and achieve the purpose of treating glaucoma. When the intraocular pressure of the patient gradually decreases due to treatment, the release rate of bimatoprost nanocrystals will decrease according to the above principle.

[0047] (3) Preparation of sustained-release gel: Stir and dissolve the prescribed amount of SAIB with N-methylpyrrolidone, ethanol, propylene glycol, phospholipids, collagen material, and PLGA at room temperature until no solid matter is left to obtain a sustained-release gel; add 4.7 mg of powder containing drugs for treating adult eye diseases such as glaucoma and presbyopia into the gel and mix evenly.

[0048] (4) The syringe and implantation needle are stored in a sterile HDPE polymer bag, and the surgical syringe plus a specially designed needle is implanted into the eyeball5.

[0049] Ingredients (Quantity per product) Raw materials Normal prescription example 1 Bimatoprost 78ug PLGA (molecular weight 30,000-38,000) 1.78mg Sucrose Isobutyrate (SAIB) 1.2mg Saturated hydrogenated soybean lecithin 0.6mg Modified collagen (high degree of polymerization) 0.22mg N-Methylpyrrolidone 2mg Anhydrous ethanol 6ug Propylene glycol 8ug PEO 1.8ug HPMC (K200M) 3ug Iron-magnesium-zinc alloy (2.8%: 51%: 46.2%) 2.8mg PLLA 3.52mg HEMA 1.2mg To prepare the sustained-release gel: (1) Stir and dissolve the prescribed amount of SAIB, N-methylpyrrolidone, ethanol, propylene glycol, phospholipids, and PLGA at room temperature until no solid matter is left to obtain a sustained-release gel; (2) adding active drugs for treating glaucoma and presbyopia in adults into the gel, mixing the mixture evenly, and storing the mixture in the syringe 11; (3) Sterile storage of syringes and implantation needles in sterile HDPE polymer bags, and implantation of surgical syringes and specially designed needles into the eyeballs 5; (4) After the surface of the eyeball 5 is disinfected and anesthetized, the front section of the needle, that is, the outer needle 2, is inserted into the eye, the syringe body is fixed, the outer needle 2 is unlocked and pulled back to expose the double-layer drug capsule to the inside of the eyeball 5; (5) Push the syringe to inject 0.18 ml of the evenly mixed sustained-release gel in the syringe into the inner bag of the medicine bag, and the medicine bag will expand; (6) Cut off the connecting rod between the outer needle 2, the inner needle and the drug release bag, so that the inner needle is separated from the eyeball 5, and the drug release hole and the drug bag are implanted into the eyeball 5 alone; (7) After the drug capsule is implanted into the eyeball 5, water in the eyeball 5 enters between the inner and outer capsules through the semipermeable membrane, and after reacting with PEO or modified cellulose, the volume expands, compressing the drug in the inner bag of the drug capsule, and enters the eyeball 5 through the drug release hole to exert a therapeutic effect; (8) After the drug release is completed (1-2 years), the drug can be supplemented with a special refilling needle; the drug release process relies on the polymer U-shaped implant, which can quickly engage with the metal beam part. After the polymer U-shaped implant is released in the body, it is taken out of the eyeball, the empty polymer U-shaped drug-loaded implant and the metal beam are separated, and then a new polymer U-shaped implant is taken, quickly engaged with the metal beam part, and then magnetically folded and transplanted into the eyeball in the same way; 0.18 ml of drug gel is injected to start the next treatment cycle; configure the sustained-release gel embodiment and comparative example.

[0050] Preparation of sustained-release gel: Stir and dissolve SAIB with different prescription amounts and N-methylpyrrolidone, ethanol, propylene glycol, phospholipids and PLGA at room temperature until no solid matter is left to obtain sustained-release gel, mix them evenly with 35 mg of antibody drug, and store them in a syringe; other processes remain unchanged.

[0051] During the working process of the present invention, the staff first connects the inner needle tube 4 and the U-shaped drug-loaded elastomer 41 from the filling port 12 to the suction rod 34, and generates suction by energizing the magnetic suction plate 33, so that the suction rod 34 and the inner needle tube 4 generate suction, and then fold the U-shaped drug-loaded elastomer 41 in half, and then fold it along the 1 / 4 of the left and right sides, and then insert the outer needle head 2 into the eyeball 5, and through the squeezing of the push rod 3 in the syringe 1, the inner needle tube 4 brings the U-shaped drug-loaded elastomer 41 into the eyeball 5, and then the staff turns off the electricity, so that after implantation, the flat, strip-shaped U-shaped part of the sustained-release skeleton will swell up and is not easy to deform, and after the drug is released in the eyeball 5, it can be modularly detached from the beam part, so that the U-shaped drug-loaded elastomer 41 returns to its original state and fits tightly inside the eyeball 5.

[0052] The description herein is provided to enable one of ordinary skill in the art to implement or use the present disclosure. Various modifications to the present disclosure will be apparent to one of ordinary skill in the art, and the general principles defined herein may be applied to other variations without departing from the scope of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but should be given the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eyeball, comprising a syringe (1), an outer needle (2), a push rod (3), an inner needle tube (4) and an eyeball (5), characterized in that: An outer needle (2) is installed on the left side of the syringe (1), a push rod (3) is installed inside the syringe (1), and an inner needle tube (4) is installed on one end of the right side of the push rod (3). The inner needle tube (4) enters the eyeball (5) through the squeezing of the push rod (3), one side surface of the inner needle tube (4) is in contact with one side surface of the piston (32), and the U-shaped drug-carrying elastomer (41) is placed inside the syringe (1); the magnetic suction plate (33) provides suction to the suction rod (34), so that the suction rod (34) with suction is connected to the inner needle tube (4) to absorb the U-shaped drug-carrying elastomer (41); one end of the inner needle tube (4) penetrates the outer surface of the outer needle (2), and the outer needle (2) penetrates the outer surface of the eyeball (5) and enters between the natural lens and the iris of the human eyeball (5), thereby completing the entry of the U-shaped drug-carrying elastomer (41) into the eyeball (5).

2. The long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eye according to claim 1, characterized in that: The cross-sectional shape of the syringe (1) is rectangular. Pull handles (11) are installed on both sides of the outside of the syringe (1). A filling port (12) is installed on the right side of the syringe (1). The filling port (12) is used to open from the middle to both sides, and the filling port (12) is convenient for replacing the inner needle tube (4) to enter the eyeball (5).

3. The long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eye according to claim 2, characterized in that: The push rod (3) has a cross-shaped cross section, and the cross-shape of the push rod (3) corresponds to the corner of the rectangle of the syringe (1). A push plate (31) for pushing the push rod (3) is installed on the left side of the push rod (3), and a piston (32) is installed on the right side of the push rod (3). The shape of the piston (32) is the same as the size and shape of the inner surface of the syringe (1). A magnetic suction plate (33) for providing suction to the parts is provided in the middle of the piston (32), and a suction rod (34) is installed on the magnetic suction plate (33). The right end of the suction rod (34) is the inner needle tube (4).

4. The long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eye according to claim 3, characterized in that: The magnetic suction plate (33) generates a certain suction force by being energized.

5. The long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eye according to claim 4, characterized in that: The inner needle tube (4) is connected to the suction rod (34), and the inner needle tube (4) transmits suction to the suction rod (34) through the magnetic suction plate (33), which is then transmitted to the inner needle tube (4) to generate suction.

6. The long-acting sustained-release drug delivery device for use between the natural lens and iris of a human eye according to claim 5, characterized in that: A U-shaped drug-carrying elastomer (41) is mounted on the inner needle tube (4). The shape of the ammunition elastic body is elliptical. The U-shaped drug-carrying elastomer (41) is an alloy composed of magnesium, iron and zinc. The U-shaped drug-carrying elastomer (41) is adsorbed onto the inner needle tube (4) by folding twice. The first folding of the U-shaped drug-carrying elastomer (41) is folded in half, and the second folding of the U-shaped drug-carrying elastomer (41) is folded along 1 / 4 of the left and right sides.

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