# US 12,109,318 B1 · Topical drug delivery devices and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,318 B1 - Document ID: US12109318B1 - Status: Granted - Kind: B1 - Application number: 18/489,631 - Filed: 2023-10-18 - Granted: 2024-10-08 - Earliest claimed: 2021-06-11 - Assignees: MJS Solutions, LLC - Applicants: MJS Solutions, LLC - Inventors: Jamie Lynn Shultz - Web page: https://patentgrep.com/patent/US12109318B1 ## CPC - A61J 1/067: {Flexible ampoules, the contents of which are expelled by squeezing} - A61K 9/7084: {Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches} - A61J 1/1443: {Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters} - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract Devices, groups of devices, kits, and methods for using the devices and kits to administer a local anesthetic to a port site to numb the site prior to infusion or blood draw are described. The devices contain a flexible material with an adhesive coating on one side and a compartment for containing the medication. The device can be pre-filled or a fillable device. In fillable devices, the local anesthetic is transferred from a container into the compartment of the device via the inlet after the device is applied to the patient's skin. In pre-filled devices, the local anesthetic is inside the compartment and is covered with a removable layer to keep it sterile until use. When applied to the patient's skin, the device conforms to the surface of the patient's skin forming a seal keeping the medication in contact with port site. ## Claims ### Claim 1 A device for the topical delivery of a topical formulation comprising one or more local anesthetics to an implanted port site on the skin of a patient, the device comprising: a flexible material and a compartment configured to contain the topical formulation, wherein the compartment comprises a side wall, a top, and an opening that is opposite the top, wherein the top is in the form of a cap, wherein the flexible material comprises a front side and a back side, wherein the compartment further comprises a flange extending from the side wall, the flange is attached to the back side of the flexible material, the flexible material surrounds the side wall, and the side wall extends beyond the front side of the flexible material, wherein an adhesive coating is on the back side of the flexible material configured to attach the device to the port site on the skin of the patient. ### Claim 2 (depends on 1) The device of claim 1, wherein the flexible material comprises an attachment portion on the back side of the flexible material, and wherein the flange is attached to the attachment portion of the flexible material. ### Claim 3 (depends on 2) The device of claim 2, wherein the attachment portion is a unitary piece with the rest of the flexible material or is a second, separate piece attached to a first piece forming the rest of the flexible material. ### Claim 4 (depends on 2) The device of claim 2, wherein a second adhesive coating is on the attachment portion of the flexible material, and wherein the second adhesive coating is the same as or different from the adhesive coating. ### Claim 5 (depends on 1) The device of claim 1, wherein the cap is configured to be opened, allowing the topical formulation to be transferred into the compartment, and wherein the cap is configured to be closed, allowing the topical formulation to be contained therein. ### Claim 6 (depends on 1) The device of claim 1, wherein the compartment is a unitary piece or formed by two or more separate parts. ### Claim 7 (depends on 6) The device of claim 6, wherein the cap is attached to a portion of the side wall of the compartment via a hinge and is able to open and close via the hinge. ### Claim 8 (depends on 6) The device of claim 6, wherein the cap is removable from the rest of the device. ### Claim 9 (depends on 8) The device of claim 8, wherein each of the cap and the side wall comprises mating threads and the cap attaches to the side wall via the mating threads. ### Claim 10 (depends on 1) The device of claim 1, wherein the cap of the compartment comprises an inlet connector configured to mate with the outlet of a container containing the topical formulation, and wherein the inlet connector comprises an inlet opening that is in fluid communication with the inside of the compartment. ### Claim 11 (depends on 1) The device of claim 1, further comprising a protective layer covering the adhesive coating on the back side of the flexible material. ### Claim 12 (depends on 1) A kit comprising the device of claim 1 and a container containing a topical formulation. ### Claim 13 (depends on 1) A method of delivering a topical formulation comprising one or more local anesthetics, to an implanted port site on the skin of a patient using the device of claim 1 comprising: placing the device onto the patient's skin such that the opening of the compartment is exposed to the port site; applying pressure to the adhesive coating on the back side of the flexible material to adhere the device to the patient's skin. ### Claim 14 (depends on 1) The device of claim 1, wherein the flexible material comprises an attachment portion, wherein a second adhesive coating is on the attachment portion of the flexible material, wherein the attachment portion is on the back side of the flexible material, wherein the second adhesive coating is the same as or different from the adhesive coating, wherein the flange is attached to the attachment portion of the flexible material, and wherein the cap is attached to a portion of the side wall of the compartment via a hinge and is able to open and close via the hinge. ### Claim 15 (depends on 1, 12) The kit of claim 12, comprising a plurality of the device of claim 1. ### Claim 16 (depends on 13) The method of claim 13, further comprising filling the compartment with the topical formulation.