Claims for Patent: 9,421,351

Summary for Patent: 9,421,351

Title:	Self-actuating applicator for microprojection array
Abstract:	An applicator for applying a microprojection member to the stratum corneum of a patient having a housing, a piston moveable within the housing and a cap adapted to activate the applicator. The applicator is self-setting and auto-triggering, which allows the applicator to be used by patient\'s having neither the strength, nor the manual dexterity to pre-set and activate other types of applicator devices.
Inventor(s):	Trautman; Joseph C. (Sunnyvale, CA), Olson; Lorin (Scotts Valley, CA)
Assignee:	ALZA CORPORATION (Mountain View, CA)
Application Number:	11/477,045
Patent Claims:	1. A device for impacting a microprojection member against the stratum corneum of a patient, comprising: a housing; a piston moveable within the housing; a cap adapted to activate the piston so the piston is capable of impacting the microprojection member against the stratum corneum of a patient; the device being one-handed self-setting and auto-triggering; an impact spring in communication with the cap and the piston, the impact spring being adapted to provide an impact force to the piston and bias the piston to an activated position, wherein the impact spring is energized when the cap and the piston are in a pre-set position; a pre-setting spring in communication with the cap and the housing, said pre-setting spring being adapted to provide a pre-setting force to the cap and bias the cap from the pre-set position to a primary position, wherein the pre-setting spring is energized when the piston is in said activated position; a first latching assembly in communication with the cap and the piston, said first latching assembly being adapted to cooperate with the cap and the pre-setting spring to return the piston to the primary position when the cap is moved from the pre-set position to the primary position; wherein said pre-setting spring is positioned around said impact spring, and wherein said pre-setting spring is not in communication with said piston, and wherein the microprojection member comprises a plurality of stratum corneum piercing blades having a dry coating disposed thereon, and wherein the coating includes at least one biologically active agent consisting of parathyroid hormone (PTH). 2. The device of claim 1, wherein said impact spring has a stored energy in the range of approximately 0.005-0.5 joules/cm.sup.2. 3. The device of claim 2, wherein said impact spring has a stored energy in the range of approximately 0.01-0.3 joules/cm.sup.2. 4. The device of claim 1, wherein said impact spring has an impact velocity in the range of approximately 0.5-20 m/sec. 5. The device of claim 4, wherein said impact spring has an impact velocity in the range of approximately 1.0-10 m/sec. 6. The device of claim 1, wherein said piston includes a face, said face having a surface area in the range of approximately 0.1-20 cm.sup.2. 7. The device of claim 6, wherein said face has a surface area in the range of approximately 1.0-10 cm.sup.2. 8. The device of claim 1, wherein the coating includes an agent formulation having at least one biologically active agent. 9. The device of claim 1, wherein the cap is adapted to move from a said primary position to a said pre-set position relative to the housing and the piston is adapted to move from the pre-set position to an activated position. 10. The device of claim 1, wherein the device does not contain a physical reservoir separate from the dry coating. 11. The device of claim 1, further comprising a second latching assembly in communication with the housing and the piston to position the piston in the pre-set position. 12. The device of claim 11, further comprising a releasing member in communication with the cap, said releasing member being adapted to communicate with the second latching assembly when the cap is moved from the primary position to the pre-set position, wherein the impact spring is energized and the releasing member disengages, whereby the piston moves from the pre-set position to the activated position and forces the microprojection member into the stratum corneum. 13. A device for impacting a microprojection member against the stratum corneum of a patient, comprising: a housing; a piston moveable within the housing; and a cap adapted to activate the piston so the piston is capable of impacting the microprojection member against the stratum corneum of a patient; the device being one-handed self-setting and auto-triggering: wherein the cap is adapted to move from a primary position to a pre-set position relative to the housing and the piston is adapted to move from the pre-set position to an activated position; an impact spring in communication with the cap and the piston, the impact spring being adapted to provide an impact force to the piston and bias the piston to an activated position, wherein the impact spring is energized when the cap and the piston are in the pre-set position; a pre-setting spring in communication with the cap and the housing, said pre-setting spring being adapted to provide a pre-setting force to the cap and bias the cap from the pre-set position to the primary position; a first latching assembly in communication with the cap and the piston, said first latching assembly being adapted to cooperate with the cap and the pre-setting spring to return the piston to the primary position when the cap is moved from the pre-set position to the primary position; wherein said pre-setting spring is positioned around said impact spring, and wherein said pre-setting spring is not in communication with said piston, and wherein the pre-setting spring is energized when the piston is in said activated position, and wherein the microprojection member comprises a plurality of stratum corneum piercing blades having a dry coating disposed thereon, and wherein the coating includes at least one biologically active agent consisting of parathyroid hormone (PTH). 14. The device of claim 13, wherein said coating includes at least one pathway patency modulator. 15. The device of claim 13, wherein said coating includes at least one vasoconstrictor. 16. The device of claim 13, wherein the device does not contain a physical reservoir separate from the dry coating. 17. The device of claim 13, further comprising a second latching assembly in communication with the housing and the piston to position the piston in the pre-set position. 18. The device of claim 17, further comprising a releasing member in communication with the cap, said releasing member being adapted to communicate with the second latching assembly when the cap is moved from the primary position to the pre-set position, wherein the impact spring is energized and the releasing member disengages, whereby the piston moves from the pre-set position to the activated position and forces the microprojection member into the stratum corneum. 19. A device for impacting a microprojection member against the stratum corneum of a patient, comprising: a housing; a piston moveable within the housing; and a cap adapted to activate the piston so the piston is capable of impacting the microprojection member against the stratum corneum of a patient; the device being one-handed self-setting and auto-triggering: wherein the cap is adapted to move from a primary position to a pre-set position relative to the housing and the piston is adapted to move from the pre-set position to an activated position; an impact spring in communication with the cap and the piston, the impact spring being adapted to provide an impact force to the piston and bias the piston to an activated position, wherein the impact spring is energized when the cap and the piston are in the pre-set position; a pre-setting spring in communication with the cap and the housing, said pre-setting spring being adapted to provide a pre-setting force to the cap and bias the cap from the pre-set position to the primary position; a first latching assembly in communication with the cap and the piston, said first latching assembly being adapted to cooperate with the cap and the pre-setting spring to return the piston to the primary position when the cap is moved from the pre-set position to the primary position; wherein said pre-setting spring is positioned around said impact spring, and wherein said pre-setting spring is not in communication with said piston, and wherein the pre-setting spring is energized when the piston is in said activated position, and wherein the microprojection member comprises a plurality of stratum corneum piercing blades having a dry coating disposed thereon, wherein said biologically active agent is selected from the group consisting of a leutinizing hormone releasing hormone (LHRH), LHRH analogs, vasopressin, desmopressin, corticotropin (ACTH), ACTH analogs, calcitonin, vasopressin, deamino [Val4, D-Arg8] arginine vasopressin, interferon alpha, interferon beta, interferon gamma, erythropoietin (EPO), granulocyte macrophage colony stimulating factor (GM-CSF), granulocyte colony stimulating factor (G-CSF), interleukin-10 (IL-10), glucagon, growth hormone release hormone (GHRH), growth hormone release factor (GHRF), insulin, insultropin, calcitonin, octreotide, endorphin, TRN, N-[[(s)-4-oxo-2-azetidinyl]carbonyl]-L-histidyl-L-prolinamide, liprecin, pituitary hormones, follicle luteoids, aANF, growth factors, bMSH, GH, somatostatin, bradykinin, somatotropin, platelet-derived growth factor releasing factor, asparaginase, bleomycin sulfate, chymopapain, cholecystokinin, chorionic gonadotropin, corticotropin (ACTH), erythropoietin, epoprostenol (platelet aggregation inhibitor), glucagon, HCG, hirulog, hyaluronidase, interferon, interleukins, menotropins (urofollitropin (FSH) and LH), oxytocin, streptokinase, tissue plasminogen activator, urokinase, vasopressin, desmopressin, ANP, ANP clearance inhibitors, angiotensin II antagonists, antidiuretic hormone agonists, bradykinn antagonists, ceredase, CSI's, calcitonin gene related peptide (CGRP), enkephalins, FAB fragments, IgE peptide suppressors, IGF-1, neurotrophic factors, colony stimulating factors, parathyroid hormone antagonists, prostaglandin antagonists, pentigetide, protein C, protein S, renin inhibitors, thymosin alpha-1, thrombolytics, TNF, vasopressin antagonists analogs, alpha-1 antitrypsin (recombinant), TGF-beta, fondaparinux, ardeparin, dalteparin, defibrotide, enoxaparin, hirudin, nadroparin, reviparin, tinzaparin, pentosan polysulfate, oligonucleotides and oligonucleotide derivatives, alendronic acid, clodronic acid, etidronic acid, ibandronic acid, incadronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, argatroban, RWJ 445167, RWJ-671818, antigens in the form of proteins, polysaccharides, oligosaccharides, lipoproteins, weakened or killed viruses such as cytomegalovirus, hepatitis B virus, hepatitis C virus, human papillomavirus, rubella virus, and varicella zoster, weakened or killed bacteria such as bordetella pertussis, clostridium tetani, corynebacterium diphtherias, group A streptococcus, legionella pneumophila, neisseria meningitides, pseudomonas aeruginosa, streptococcus pneumoniae, treponema pallidum, and vibrio cholerae and mixtures thereof. 20. The device of claim 19, wherein the device does not contain a physical reservoir separate from the dry coating. 21. The device of claim 19, further comprising a second latching assembly in communication with the housing and the piston to position the piston in the pre-set position. 22. The device of claim 21, further comprising a releasing member in communication with the cap, said releasing member being adapted to communicate with the second latching assembly when the cap is moved from the primary position to the pre-set position, wherein the impact spring is energized and the releasing member disengages, whereby the piston moves from the pre-set position to the activated position and forces the microprojection member into the stratum corneum.

Details for Patent 9,421,351

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	01/15/1974		2023-10-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	12/27/1984		2023-10-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/15/1985		2023-10-31