Self-actuating applicator for microprojection array

• US 20070027427A1
• Filed: 06/27/2006
• Published: 02/01/2007
• Est. Priority Date: 10/31/2003
• Status: Active Grant

• Current Assignee: Joseph Trautman, Lorin Olson
• Original Assignee: Joseph Trautman, Lorin Olson
• Inventors: Trautman, Joseph, Olson, Lorin
• Granted Patent: US 9,421,351 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;

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.

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 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.

10. The device of claim 9, further comprising 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.

11. The device of claim 9, further comprising 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, wherein the pre-setting spring is energized when the piston is in said activated position.

12. 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, wherein the pre-setting spring is energized when the piston is in said activated position.

13. 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 atratum 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 microjection member openings; and

an applicator, the applicator 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.

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

15. The delivery system of claim 14, 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.

16. The delivery system of claim 14, 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.

17. The delivery system of claim 13, wherein said hydrogel formulation includes at least one pathway patency modulator.

18. The delivery system of claim 13, wherein said hydrogel formulation includes at least one vasoconstrictor.