Self-actuating applicator for microprojection array

• US 20050096586A1
• Filed: 10/21/2004
• Published: 05/05/2005
• Est. Priority Date: 10/31/2003
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Trautman, Joseph C., Olson, Lorin
• Granted Patent: US 7,097,631 B2
• Time in Patent Office: Days
• US Class Current: 604/46
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2017/925 a spring
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

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.

Claims

1. A device for impacting a microprojection member against the stratum corneum of a patient, comprising:

a housing having a first and second end, said first end of said housing being adapted to receive said microprojection member;

a cap that is adapted to move from a primary position to a pre-set position relative to said housing;

a piston slideably disposed within said housing for impacting said microprojection member against the stratum corneum, said piston being adapted to move from said pre-set position to an activated position;

an impact spring in communication with said cap and said piston, said impact spring being adapted to provide and an impact force to said piston and bias said piston out of said first end of said housing toward an activated position proximate the stratum corneum, wherein said impact spring is energized when said cap and said piston are in said pre-set position;

a pre-setting spring in communication with said cap and said housing, said pre-setting spring being adapted to provide a pre-setting force to said cap and bias said cap from said pre-set position to said primary position, wherein said pre-setting spring is energized when said piston is in said activated position;

a first latching assembly in communication with said cap and said piston, said first latching assembly being adapted to cooperate with said cap and said pre-setting spring to return said piston to said primary position when said cap is moved from said pre-set position to said primary position;

a second latching assembly in communication with said housing and said piston to position said piston in said pre-set position; and

a releasing member in communication with said cap, said releasing member being adapted to communicate with said second latching assembly when said cap is moved from said primary position to said pre-set position, wherein said impact spring is energized and said second latching assembly disengages, whereby said piston moves from said pre-set position to said activated position and forces said microprojection member into the stratum corneum.

2. The device of claim 1, wherein said impact spring has a stored energy in the range of approximately 0.005-0.5 joules/cm².

3. The device of claim 2, wherein said impact spring has a stored energy in the range of approximately 0.01-0.3 joules/cm².

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 cm².

7. The device of claim 6, wherein said face has a surface area in the range of approximately 1.0-10 cm².

8. The device of claim 1, wherein said microprojection member includes an agent formulation having at least one biologically active agent.

9. The device of claim 1, wherein said second latching assembly is disposed on the outside of said impact spring.

10. The device of claim 1, wherein said pre-setting spring is disposed on the outside of said impact spring.

11. A device for impacting a microprojection member against the stratum corneum of a patient, comprising:

a housing having a first and second end;

a retainer adapted to engage said housing proximate said second end, said retainer being further adapted to receive and position said microprojection member;

a cap that is adapted to move from a primary position to a pre-set position relative to said housing;

a piston slideably disposed within said housing for impacting said microprojection member against the stratum corneum, said piston being adapted to move from said pre-set position to an activated position;

an impact spring in communication with said cap and said piston, said impact spring being adapted to provide and an impact force to said piston and bias said piston out of said first end of said housing toward an activated position proximate the stratum corneum, wherein said impact spring is energized when said cap and said piston are in said pre-set position;

a pre-setting spring in communication with said cap and said housing, said pre-setting spring being adapted to provide a pre-setting force to said cap and bias said cap from said pre-set position to said primary position, wherein said pre-setting spring is energized when said piston is in said activated position;

a first latching assembly in communication with said cap and said piston, said first latching assembly being adapted to cooperate with said cap and said pre-setting spring to return said piston to said primary position when said cap is moved from said pre-set position to said primary position;

a second latching assembly in communication with said housing and said piston to position said piston in said pre-set position; and

a releasing member in communication with said cap, said releasing member being adapted to communicate with said second latching assembly when said cap is moved from said primary position to said pre-set position, wherein said impact spring is energized and said second latching assembly disengages, whereby said piston moves from said pre-set position to said activated position and forces said microprojection member into the stratum corneum.

12. A transdermal delivery system for delivering a biologically active agent to a patient, comprising:

a patch system, said patch system including a gel pack containing a hydrogel formulation and a microprojection member having top and bottom surfaces, a plurality of openings that extend through said microprojection member and a plurality of stratum corneum-piercing microprojections that project from said bottom surface of said microprojection member, said microprojection member being adapted to receive said gel pack whereby said hydrogel formulation flows through said microprojection member openings; and

an applicator, said applicator including a housing having a first and second end, a cap that is adapted to move from a primary position to a pre-set position relative to said housing, said first end of said housing being adapted to receive said microprojection member, a piston slideably disposed within said housing for impacting said microprojection member against the stratum corneum, said piston being adapted to move from said pre-set position to an activated position proximate the stratum corneum, an impact spring in communication with said cap and said piston, said impact spring being adapted to provide an impact force to said piston and bias said piston out of said first end of said housing toward said activated position, wherein said impact spring is energized when said cap and said piston are in said pre-set position, a pre-setting spring in communication with said cap and said housing, said pre-setting spring being adapted to provide a pre-setting force to said cap and bias said cap from said pre-set position to said primary position, wherein said pre-setting spring is energized when said piston is in said activated position, a first latching assembly in communication with said cap and said piston, said first latching assembly being adapted to cooperate with said cap and said pre-setting spring to return said piston to said primary position when said cap is moved from said pre-set position to said primary position, a second latching assembly in communication with said housing and said piston to position said piston in said pre-set position, and a releasing member in communication with said cap, said releasing member being adapted to communicate with said second latching assembly when said cap is moved from said primary position to said pre-set position, wherein said impact spring is energized and said second latching assembly disengages, whereby said piston moves from said pre-set position to said activated position and forces said microprojection member into the stratum corneum.

13. The delivery system of claim 12, wherein said hydrogel formulation includes at least one biologically active agent.

14. The delivery system of claim 13, 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, parathyroid hormone (PTH), 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 (PTH) and agonists, 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, and mixtures thereof.

15. The delivery system of claim 13, wherein said biologically active agent is selected from the group consisting of 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 diphtheriae, group A streptococcus, legionella pneumophila, neisseria meningitides, pseudomonas aeruginosa, streptococcus pneumoniae, treponema pallidum, and vibrio cholerae and mixtures thereof.

16. The delivery system of claim 12, wherein said hydrogel formulation includes at least one pathway patency modulator.

17. The delivery system of claim 12, wherein said hydrogel formulation includes at least one vasoconstrictor.