Claims for Patent: 11,097,061

Summary for Patent: 11,097,061

Title:	Systems, kits and methods for loading and delivering a small volume dose from a syringe
Abstract:	A kit is disclosed for accurately loading a small volume dose of a medication within a syringe and for delivering the small volume dose of the medication at a treatment site. The kit generally includes a loading and delivery system in accordance herewith, a syringe, and a medication. The loading and delivery system includes a syringe delivery ring and a syringe loading guide, which may be used for example, to administer a small volume dose of a medication at the end of an ocular surgery.
Inventor(s):	Gerlett; Cathy Ann (Klamath Falls, OR)
Assignee:	ICON BIOSCIENCE, INC. (Watertown, MA)
Application Number:	16/269,910
Patent Claims:	1. A kit for accurately loading a small volume dose of medication within a syringe and for delivering the small volume dose of medication at a treatment site, the kit comprising: a syringe including a plunger and a barrel for holding a medication, the plunger including a plunger rod, a plunger flange at a proximal end of the plunger rod and a plunger seal at a distal end of the plunger rod, wherein the barrel includes a barrel flange at a proximal end of the barrel and wherein the barrel is sized to receive a length of the plunger rod and the plunger seal therein; a syringe delivery ring including a lumen and a sidewall opening that extend from a proximal end to a distal end thereof, the sidewall opening being configured to permit the plunger rod of the syringe to traverse the sidewall opening and to be slidably received within the lumen of the syringe delivery ring to thereby couple the syringe delivery ring to the plunger rod, and the syringe delivery ring further including a proximal segment and a distal segment, wherein the proximal segment has a smaller outer diameter than the distal segment and the distal segment has a proximal-facing bearing surface; and a syringe loading guide including a proximal-facing surface for abutting with the plunger flange of the syringe during loading, a distal-facing surface for abutting with the proximal-facing bearing surface of the distal segment of the syringe delivery ring during loading, and a coupling archway configured to attach to the proximal segment of the syringe delivery ring during loading, wherein a first height of the syringe loading guide is greater than a second height of the proximal segment of the syringe delivery ring; and a medication for loading within and for delivery by the syringe, wherein a difference between the first height of the syringe loading guide and the second height of the proximal segment of the syringe delivery ring corresponds to a distance the plunger seal travels within the barrel of the syringe to deliver a small volume dose of the medication. 2. The kit of claim 1, wherein when the syringe loading guide is disposed on the syringe delivery ring during loading, with the plunger flange in abutment with the proximal-facing surface of the syringe loading guide, the difference between the first height of the syringe loading guide and the second height of the proximal segment of the syringe delivery ring also corresponds to a distance defined between the proximal end of the syringe delivery ring and the plunger flange. 3. The kit of claim 1, wherein the proximal-facing bearing surface of the distal segment of the syringe delivery ring is configured to stabilize the syringe loading guide during loading of the medication. 4. The kit of claim 1, further comprising a syringe needle. 5. The kit of claim 1, further comprising a syringe cannula. 6. The kit of claim 1, wherein the medication is contained in one of a vial and the barrel of the syringe. 7. The kit of claim 6, wherein the medication comprises dexamethasone suspended in acetyl triethyl citrate. 8. The kit of claim 7, wherein the medication is contained within the vial and comprises 0.5 mL of 9% w/w dexamethasone suspended in acetyl triethyl citrate. 9. The kit of claim 6, wherein the medication comprises 9% w/w dexamethasone suspended in acetyl triethyl citrate. 10. The kit of claim 9, wherein the small volume dose of the medication to be delivered comprises 5 .mu.l of 9% w/w dexamethasone (equivalent to 517 micrograms) suspended in acetyl triethyl citrate. 11. A loading and delivery system for use with a syringe to accurately load a small volume dose of medication within the syringe and to deliver the small volume dose from the syringe at a treatment site, the system comprising: a syringe delivery ring including a lumen and a sidewall opening that extend from a proximal end to a distal end thereof, the sidewall opening being configured to permit a plunger rod of the syringe to traverse the sidewall opening and to be slidably received within the lumen of the syringe delivery ring to thereby couple the syringe delivery ring to the plunger rod, and the syringe delivery ring further including a proximal segment and a distal segment, wherein the proximal segment has a smaller outer diameter than the distal segment and the distal segment has a proximal-facing bearing surface; and a syringe loading guide including a proximal-facing surface configured to abut with a plunger flange of the plunger rod of the syringe during loading, a distal-facing surface configured to abut with the proximal-facing bearing surface of the distal segment of the syringe delivery ring during loading, and a coupling archway that is configured to attach to the proximal segment of the syringe delivery ring during loading, wherein a first height of the syringe loading guide is greater than a second height of the proximal segment of the syringe delivery ring, and wherein when the system is coupled to the syringe, with the syringe loading guide attached to the syringe delivery ring whereby the proximal segment of the syringe delivery ring is received within the coupling archway of the syringe loading guide with the distal-facing surface of the syringe loading guide in abutment with the proximal-facing bearing surface of the distal segment of the syringe delivery ring, a distance between the proximal-facing surface of the syringe loading guide and the proximal end of the syringe delivery ring corresponds to the small volume dose of medication to be delivered from the syringe. 12. The system of claim 11, wherein when the system is coupled to the syringe in a dose loaded configuration, the plunger rod of the syringe is slidably received within the lumen of the syringe delivery ring with the distal end of the syringe delivery ring in abutment with a barrel flange of the syringe, and the proximal segment of the syringe delivery ring is received within the coupling archway of the syringe loading guide with the distal-facing surface of the syringe loading guide in abutment with the proximal-facing bearing surface of the distal segment of the syringe delivery ring, and the proximal-facing surface of the syringe loading guide in abutment with the plunger flange of the syringe, such that the distance between the proximal-facing surface of the syringe loading guide and the proximal end of the syringe delivery ring, which is the distance between the plunger flange of the syringe and the proximal end of the syringe delivery ring, corresponds to a distance a plunger seal of the syringe will travel within a barrel of the syringe to deliver the small volume dose of medication. 13. The system of claim 12, wherein when the system is coupled to the syringe in a dose delivered configuration, after removal of the syringe loading guide and delivery of the small volume dose from the syringe at the treatment site, the distal end of the syringe delivery ring remains in abutment with the barrel flange of the syringe, the plunger flange of the syringe is in abutment with the proximal end of the syringe delivery ring, and the syringe delivery ring is configured to prevent the plunger seal from contacting a distal end of the barrel of the syringe, wherein the distance traveled by the plunger seal as the system transitions from the dose loaded configuration to the dose delivered configuration corresponds to the small volume dose of medication delivered from the syringe. 14. A method of accurately loading a first volume of medication into a syringe and delivering a desired second volume of medication at a desired treatment site, the method comprising the steps of: utilizing a kit according to claim 1 including a medication loaded within a barrel of the syringe; withdrawing the plunger from the barrel of the syringe approximately 1 inch; placing the syringe delivery ring adjacent to an exposed plunger rod of the plunger with the sidewall opening of the syringe delivery ring facing the plunger; applying pressure to the syringe delivery ring to slidably receive within the lumen of the syringe delivery ring the exposed plunger rod and to thereby couple the syringe delivery ring to the plunger rod of the syringe; releasably coupling a needle of the syringe to a distal end of the syringe; depressing the plunger, then withdrawing the plunger to fill the syringe with air; inserting the needle of the syringe into a vial filled with the medication, then depressing the plunger to inject the air into the vial; withdrawing the plunger to fill the barrel with the medication; removing the needle of the syringe from the vial; depressing the plunger to expel any remaining air from the syringe; positioning the syringe loading guide over a small diameter portion of the syringe delivery ring and the exposed plunger such that the small diameter portion of the syringe delivery ring and a portion of the exposed plunger are received within an opening of the syringe loading guide and the distal facing surface of the syringe loading guide abuts the proximal-facing bearing surface of the syringe delivery ring; depressing the plunger until the plunger flange of the plunger contacts the proximal facing surface of the syringe loading guide thereby leaving a first volume of the medication to be contained within the barrel of the syringe; removing the syringe loading guide from the syringe delivery ring and the exposed plunger rod; positioning the needle of the syringe at the desired treatment site; and depressing the plunger until the plunger flange contacts the proximal end of the syringe delivery ring to deliver a desired second volume of the medication that is less than the first volume of the medication. 15. The method of claim 14, further comprising preparing the medication by agitating the vial containing the medication to suspend the medication within a solution. 16. The method of claim 14, further comprising, after removing the needle of the syringe from the vial, exchanging the needle of the syringe with a syringe cannula and positioning the syringe cannula at the desired treatment site for delivering the desired second volume of the medication.