# US 11,110,226 B2 · Syringe > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,226 B2 - Document ID: US11110226B2 - Status: Granted - Kind: B2 - Application number: 16/811,430 - Filed: 2020-03-06 - Published: 2020-07-09 - Granted: 2021-09-07 - Earliest claimed: 2012-06-01 - Assignees: Novartis AG - Applicants: Novartis AG - Inventors: Andrew Bryant; Heinrich Buettgen; Wolfgang Papst; Marie Picci - Web page: https://patentgrep.com/patent/US11110226B2 ## CPC - A61M 5/31513: {Piston constructions to improve sealing or sliding} - A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles} - A61M 5/28: Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle - A61M 5/31505: {Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit} - A61P 27/02: Ophthalmic agents - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts} - A61M 5/3137: {with finger grip means, e.g. for easy manipulation of the syringe rod} - A61M 2005/3104: {Caps for syringes without needle} - A61M 2005/3139: {Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips} - A61M 2005/31508: {provided on the piston-rod} - Y10T 29/49826: Assembling or joining - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract The invention provides a syringe for use in an ophthalmic injection. The syringe comprises a body, a stopper and a plunger. The body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet. The plunger comprises a plunger contact surface at a first end and a rod extends between the plunger contact surface and a rear portion. The plunger contact surface is arranged to contact the stopper but not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, reducing the volume of the variable volume chamber, but not to move the stopper away from the outlet end. ## Claims ### Claim 1 A packaged, small volume, terminally sterilized syringe, comprising a small volume, terminally sterilized syringe including: a body, a stopper, and a plunger, wherein the body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet, wherein the plunger comprises a plunger contact surface at a first end and a rod extending between the plunger contact surface and a rear portion, the plunger contact surface is arranged to contact the stopper but does not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, thereby reducing the volume of the variable volume chamber, but does not to move the stopper away from the outlet end, whereby the syringe is suitable for ophthalmic injection, wherein the stopper comprises at least a front circumferential rib and a rear circumferential rib which are separated in a direction along the longitudinal axis of the body to define a sterility zone having a length of at least 3 mm, wherein the rod includes at least one rod shoulder directed away from the outlet end and the syringe includes a backstop arranged at a rear portion of the body, the backstop including a backstop shoulder directed towards the outlet end to cooperate with and contact the rod shoulder to limit movement of the plunger away from the outlet end to a distance less than the length of the sterility zone, wherein when the plunger contact surface is in contact with the stopper the backstop shoulder and rod shoulder are not in contact with one another, wherein the syringe is dimensioned to have a nominal maximum fill volume of between 0.25 ml and 0.75 ml and the variable volume chamber is filled with 40 mg/ml solution of aflibercept, and the dosage volume is 0.05 ml, a sealed package, wherein the small volume, terminally sterilized syringe is enclosed within the sealed package. ### Claim 2 (depends on 1) The syringe according to claim 1, wherein the variable volume chamber has an internal diameter between about 3 mm and about 6 mm. ### Claim 3 (depends on 1) The syringe according to claim 1, wherein the length of the body of the syringe is less than 70 mm. ### Claim 4 (depends on 1) The syringe according to claim 1, which is substantially silicone free. ### Claim 5 (depends on 1) The syringe according to claim 1, wherein the body is made out of plastic or glass. ### Claim 6 (depends on 1) The syringe according to claim 1, which is dimensioned so as to have a nominal maximum volume between about 0.4 ml and about 0.6 ml. ### Claim 7 (depends on 6) The syringe according to claim 6, wherein the nominal maximum volume is about 0.5 ml. ### Claim 8 (depends on 1) The syringe according to claim 1, which has an internal diameter between about 4.5 mm and about 4.8 mm. ### Claim 9 (depends on 1) The syringe according to claim 1, wherein the outlet is reversibly sealed with a sealing device. ### Claim 10 (depends on 1) The syringe of claim 1, wherein the front circumferential rib and the rear circumferential rib are separated in a direction along the longitudinal axis of the body by at least 3.5 mm. ### Claim 11 (depends on 1) The syringe of claim 1, wherein the front circumferential rib and the rear circumferential rib are separated in a direction along the longitudinal axis of the body by at least 3.75 mm. ### Claim 12 (depends on 1) The syringe of claim 1, wherein the front circumferential rib and the rear circumferential rib are separated in a direction along the longitudinal axis of the body by at least 4 mm. ### Claim 13 (depends on 1) The syringe of claim 1, which comprises a total of three circumferential ribs. ### Claim 14 (depends on 1) The syringe of claim 1, which further comprises one or more additional circumferential ribs arranged between the front circumferential rib and the rear circumferential rib. ### Claim 15 (depends on 14) The syringe of claim 14, which further comprises two or more additional circumferential ribs. ### Claim 16 A method of assembling a packaged, small volume, terminally sterilized syringe, the method comprising: a. providing a body and a stopper, wherein the body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet, and wherein the outlet is releasably sealed and the variable volume chamber contains a medicament, wherein the stopper comprises at least a front circumferential rib and a rear circumferential rib which are separated in a direction along the longitudinal axis of the body to define a sterility zone having a length of at least 3 mm; and b. providing a plunger comprising a plunger contact surface at a first end and a rod extending between the plunger contact surface and a rear portion and arranging the plunger contact surface and at least part of the plunger within the body without coupling the plunger to the stopper, wherein i. the rod includes at least one rod shoulder directed away from the outlet end and the syringe includes a backstop arranged at a rear portion of the body, the backstop including a backstop shoulder directed towards the outlet end to cooperate with and contact the rod shoulder to prevent movement of the plunger away from the outlet end to a distance less than the length of the sterility zone, wherein when the plunger contact surface is in contact with the stopper the backstop shoulder and the rod shoulder are not in contact with one another, ii. ii) the syringe is dimensioned to have a nominal maximum fill volume of between 0.25 ml and 0.75 ml, iii. the variable volume chamber is filled with 40 mg/ml solution of aflibercept, and the dosage volume is 0.05 ml; c. enclosing and sealing the syringe into a package; and d. sterilizing the packaged syringe in a terminal sterilization process. ### Claim 17 A method for treating an ocular disease in a subject in need thereof comprising administering to the subject an effective amount of aflibercept in a small volume, terminally sterilized syringe, wherein the syringe comprises a body, a stopper, and a plunger, wherein the body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet, wherein the stopper comprises at least a front circumferential rib and a rear circumferential rib which are separated in a direction along the longitudinal axis of the body to define a sterility zone having a length of at least 3 mm, wherein the plunger comprises a plunger contact surface at a first end and a rod extending between the plunger contact surface and a rear portion, the plunger contact surface is arranged to contact the stopper but does not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, thereby reducing the volume of the variable volume chamber, but does not to move the stopper away from the outlet end, whereby the syringe is suitable for ophthalmic injection, and wherein: a) the rod includes at least one rod shoulder directed away from the outlet end and the syringe includes a backstop arranged at a rear portion of the body, the backstop including a backstop shoulder directed towards the outlet end to cooperate with and contact the rod shoulder to limit movement of the plunger rod away from the outlet end to a distance less than the length of the sterility zone, wherein when the plunger contact surface is in contact with the stopper the backstop shoulder and the rod shoulder are not in contact with one another, b) the syringe is dimensioned to have a nominal maximum fill volume of between 0.25 ml and 0.75 ml; and c) wherein the variable volume chamber is filled with 40 mg/ml solution of aflibercept, and the dosage volume is 0.05 ml. ### Claim 18 (depends on 17) The method of claim 17, wherein the ocular disease is selected from the group consisting of choroidal neovascularisation, age related macular degeneration, macular edema secondary to retinal vein occlusion (RVO), including both branch RVO (bRVO) and central RVO (cRVO), choroidal neovascularisation secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, and proliferative retinopathy. ### Claim 19 (depends on 17) The method of claim 17, wherein the variable volume chamber has an internal diameter between about 3 mm and about 6 mm. ### Claim 20 (depends on 17) The method of claim 17, wherein the length of the body of the syringe is less than 70 mm. ### Claim 21 (depends on 17) The method of claim 17, wherein the syringe is substantially silicone free. ### Claim 22 (depends on 17) The method of claim 17, wherein the body is made out of plastic or glass. ### Claim 23 (depends on 17) The method of claim 17, wherein the syringe is dimensioned so as to have a nominal maximum volume between about 0.4 ml and about 0.6 ml. ### Claim 24 (depends on 23) The method of claim 23, wherein the nominal maximum volume is about 0.5 ml. ### Claim 25 (depends on 17) The method of claim 17, wherein the syringe has an internal diameter between about 4.5 mm and about 4.8 mm. ### Claim 26 (depends on 17) The method of claim 17, wherein the outlet is reversibly sealed with a sealing device.