Claims for Patent: 9,440,056

Summary for Patent: 9,440,056

Title:	Device and method for dispensing a drug
Abstract:	A device for dispensing a topically administered drug has a spreader which is used to actuate a pump to release the drug and then to spread the drug on the skin and. The spreader is coupled to a lock that prevents it from actuating the pump after a number of drug doses have been dispensed. The pump can be actuated to release no more than the selected quantity of drug per day or actuation.
Inventor(s):	Hofland; Hans (Menlo Park, CA), Imbert; Delphine Caroline (Menlo Park, CA), O\'Connell; Daniel (Broughton, GB), Pearson; Allen (Broughton, GB)
Assignee:	Demira, Inc. (Menlo Park, CA)
Application Number:	14/869,799
Patent Claims:	1. A device for dispensing a drug, the device comprising: a case; a spreader for spreading a drug on the skin, the spreader extending out of the case; a container for the drug, the container disposed within the case and including a pump configured to be actuated to deliver the drug to the spreader; and a lock within the case, the lock configured to prevent actuation of the pump when the pump has been actuated to a numerical limit of the lock, wherein the lock includes a dose counter part coupled to the spreader, the dose counter part includes a visual indicator that is visible through an aperture in the case, the dose counter part rotates with axial movement of the spreader into the case, and the rotation of the dose counter part moves the visual indicator within the aperture, and wherein the lock includes a ratcheting part operatively coupled to the dose counter part, the ratcheting part rotates with axial movement of the spreader into the case, the rotation of the ratcheting part rotates the dose counter part, and the ratcheting part is operatively coupled to the dose counter part by one or more intermediate gears. 2. The device of claim 1, wherein the spreader includes a plurality of spreader teeth, the spreader teeth rotate the ratcheting part with axial movement of the spreader into the case. 3. The device of claim 2, wherein the spreader includes a first portion and a second portion, the first portion is mounted on a tip of the container, the second portion covers the first portion and forms an exposed surface of the spreader outside of the case, the ratcheting part includes a cylindrical wall disposed between the first portion and the second portion, the ratcheting part includes a plurality of angled teeth on the cylindrical wall, and the angled teeth are configured to engage the spreader teeth. 4. The device of claim 3, wherein the ratcheting part includes gear teeth operatively coupled to the dose counter part, the gear teeth are closer to a rotation axis of the ratcheting part than the angled teeth of the ratcheting part. 5. The device of claim 1, wherein the ratcheting part includes a through hole in which the container extends. 6. The device of claim 1, wherein the axial movement of the spreader into the case is in a direction parallel to a central axis of the spreader. 7. The device of claim 6, wherein a rotation axis of the dose counter part is coincident with the central axis of the spreader. 8. The device of claim 1, wherein the drug is: tretinoin; benzocaine, butamben, dibucaine, lidocaine, oxybuprocaine, pramoxine, proparacaine, proxymetacaine, or tetracaine; erythromycin, benzoyl peroxide, clindamycin, penederm, sodium sulfacetamide, adapalene or Tazorac; becaplermin; minoxidil; tigecycline, clindamycin or butenafine; podofilox; betamethasone; luliconazole, terbinafine or terbinafine hydrochloride; tacrolimus; azelaic acid; ivermectin; ingenol mebutate; polidocanol; mechlorethamine; efinaconazole; glycopyrronium bromide; glycopyrronium tosylate; or an aluminum salt. 9. The device of claim 1, wherein the drug is for administration to any region of the skin. 10. The device of claim 1, wherein the drug is for administration to: one or more axilla; one or more hands; one or more palms; one or more feet; one or more foot soles; the face; the forehead; the back; the lower back; the upper back; or to the genitals. 11. A device for dispensing a drug, the device comprising: a container for a drug; and a spreader connected to the container and having an exposed surface for spreading the drug on skin, the exposed surface including a plurality of drug outlets that dispense the drug from the container, the exposed surface further including a plurality of concave drug channels arranged around a central axis of the spreader, at least some of the drug outlets being located within the drug channels, each drug channel having an oval perimeter, the oval perimeter defined by a round narrow end, a round wide end, and a groove central region between the round narrow end and the round wide end, the round wide end having a radius of curvature greater than that of the round narrow end, the round narrow ends of the oval perimeters converge toward each other and are closer to the central axis than the round wide ends, each drug channel having a depth that varies within the oval perimeter, the depth being greater at the groove central region than at the round narrow end and the round wide end. 12. The device of claim 11, wherein at least some of the drug outlets are located in the round narrow end of the oval perimeter of each drug channel. 13. The device of claim 11, wherein none of the drug outlets present on the spreader are located in any of the round wide ends of the oval perimeters of the drug channels. 14. The device of claim 11, wherein none of the drug outlets present on the spreader are located in any of the groove central regions of the oval perimeters of the drug channels. 15. The device of claim 11, wherein all of the drug outlets present on the spreader are located within the oval perimeters of the drug channels. 16. The device of claim 11, wherein spreader includes: a first portion having a first portion upper surface and a first portion lower surface, the first portion lower surface coupled to the container; and a second portion disposed over the first portion and having a second portion upper surface and a second portion lower surface facing the first portion upper surface, the second portion upper surface being the exposed surface in which the drug channels and drug outlets are formed, and wherein the first portion upper surface and the second portion lower surface define drug passageways that extend to the drug outlets, and areas of the first portion upper surface between the drug passageways are in contact with the second portion lower surface. 17. A device for dispensing a drug, the device comprising: a spreader for spreading the drug, the spreader including a first portion and a second portion, the first portion having a first portion upper surface and a first portion lower surface, the second portion having a second portion upper surface for applying the drug onto skin and a second portion lower surface, the second portion lower surface is disposed on and in contact with the first portion upper surface, wherein a drug inlet is formed through the first portion lower surface, a drug passageway extends from the drug inlet to an aperture formed in the first portion upper surface, at least one concave drug channel is formed in the second portion upper surface, each drug channel has a depth that varies, each drug channel includes a first groove region and a second groove region, the depth is greatest at the second groove region as compared to all other regions of the drug channel, a plurality of drug outlets are formed through the second portion upper surface, at least some of the drug outlets are located in the first groove region of the at least one concave drug channel, and none of the drug outlets present on the second portion upper surface are located in any second groove region on the second portion upper surface. 18. The device of claim 17, wherein all the drug outlets present on the second portion upper surface are located in the first groove region of the at least one concave drug channel. 19. The device of claim 17, wherein the at least one concave drug channel includes two or more concave drug channels, each of the drug channels includes its own first groove region and second groove region, the depth of the drug channel is greatest at the second groove region as compared to all other regions of the drug channel. 20. The device of claim 17, wherein each concave drug channel has an oval perimeter, the oval perimeter is defined by the first groove region, the second groove region, and a third groove region, the second groove region is disposed between the first groove region and the third groove region, the third groove region has a radius of curvature at the perimeter that is greater than that of the first groove region, the first groove regions of the oval perimeters converge toward each other and are closer to a central axis of the spreader than the third groove region, and the depth is greater at the second groove region than at the first and third groove regions. 21. The device of claim 17, wherein the aperture formed in the first portion upper surface provides the drug to all the drug outlets, and none of the drug outlets are located directly above the aperture. 22. The device of claim 17, wherein device further comprises a container for the drug, the container coupled to the drug inlet formed through the first portion lower surface, wherein the first portion upper surface and the second portion lower surface define drug passageways that extend from the aperture formed in the first portion upper surface to the drug outlets.

Details for Patent 9,440,056

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	12/16/1997		2034-09-29