Programmable Multi-Dose Intransal Drug Delivery Device

Transcription

1 University of Kentucky UKnowledge Mechanical Engineering Faculty Patents Mechanical Engineering Programmable Multi-Dose Intransal Drug Delivery Device Daniel Wermeling University of Kentucky, Ryan Vallance University of Kentucky Aravind Balasubramanian University of Kentucky, Bruce L. Walcott University of Kentucky, John Alan Main University of Kentucky, See next page for additional authors Click here to let us know how access to this document benefits you. Follow this and additional works at: Part of the Mechanical Engineering Commons Recommended Citation Wermeling, Daniel; Vallance, Ryan; Balasubramanian, Aravind; Walcott, Bruce L.; Main, John Alan; and Lumpp, James E. Jr., "Programmable Multi-Dose Intransal Drug Delivery Device" (2005). Mechanical Engineering Faculty Patents This Patent is brought to you for free and open access by the Mechanical Engineering at UKnowledge. It has been accepted for inclusion in Mechanical Engineering Faculty Patents by an authorized administrator of UKnowledge. For more information, please contact

2 Authors Daniel Wermeling, Ryan Vallance, Aravind Balasubramanian, Bruce L. Walcott, John Alan Main, and James E. Lumpp Jr. This patent is available at UKnowledge:

3 (12) United States Patent Wermeling et al. US B2 (10) Patent N0.: (45) Date of Patent: US 6,948,492 B2 Sep. 27, 2005 (54) (75) (73) (*) (21) (22) (86) (87) (65) (60) (51) (52) (58) PROGRAMMABLE MULTI-DOSE INTRANASAL DRUG DELIVERY DEVICE Inventors: Daniel P. Wermeling, Lexington, KY (US); Ryan Vallance, Lexington, KY (US); Aravind Balasubramaniam, Lexington, KY (US); Bruce Lanier Walcott, Lexington, KY (US); John Alan Main, Lexington, KY (US); James E. Lumpp, Jr., Lexington, KY (Us) Assigneei University of Kentucky Research Foundation, Lexington, KY (US) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 175 days. Appl. No.: 10/129,578 PCT Filed: Aug. 15, 2001 PCT No.: PCT/US01/ (6X1), (2), (4) Date: Mar. 20, 2003 PCT Pub. No.: WO02/13886 PCT Pub. Date: Feb. 21, 2002 Prior Publication Data US 2003/ A1 Aug. 28, 2003 Related U.S. Application Data Provisional application No. 60/225,624,?led on Aug. 15, Int. Cl A61M 11/00 U.S. Cl /200.14; 128/200.17; 128/203.15; 128/ Field of Search /200.14, , 128/200.23, , , (56) References Cited U.S. PATENT DOCUMENTS 3,812,853 A 5/1974 Crain 4,464,378 A 8/1984 Hussain 4,627,432 A * 12/1986 NeWell et al / ,673,679 A 6/1987 Aungst et al. 4,782,047 A 11/1988 Benjamin et al. 4,889,860 A 12/1989 RZesZotarski 4,946,069 A 8/1990 Fuchs 4,950,664 A 8/1990 Goldberg 4,973,596 A 11/1990 Cohen 5,035,237 A * 7/1991 NeWell et al / ,132,114 A 7/1992 Stanley et al. 5,169,029 A 12/1992 Behar et al. 5,207,217 A * 5/1993 CocoZZa et al / (Continued) FOREIGN PATENT DOCUMENTS W0 WO 90/ /1990 W0 W0 02/ A1 2/2002 Primary Examiner Glenn K. DaWson Assistant Examiner DarWin P. EreZo (74) Attorney, Agent, or Firm Mayer BroWn RoWe & MaW LLP (57) ABSTRACT An apparatus and method for the self-administration of a plurality of doses of an intranasal liquid pharmaceutical composition, including opioid analgesics, that includes a drug delivery device containing a plurality of sealed vials, each vial containing a predetermined volume of the phar maceutical composition, a pump assembly for conveying the liquid pharmaceutical composition from the interior of the vial and discharging it as a nasal spray in response to manual activation by the patient, and programmable means for sequentially advancing a vial to the ready position after passage of a prescribed time interval following the last activation of the delivery device. 47 Claims, 21 Drawing Sheets

4 US 6,948,492 B2 Page 2 US. PATENT DOCUMENTS 5,958,379 A 9/1999 Regenold 6,015,797 A 1/2000 Camborde et ,225,183 A 7/1993 Purewal et ,017,963 A Alfonso et a g/igg s geggn d 1 6,029,663 A * 2/2000 B / A Bechgaard 6: 11' 6,065,472 A * 5/2000 Anderson et a / ga.6 a RE36,744 E 6/2000 Goldberg 5,492,112 A * 2/1996 Meclkalskl et a1. 128/ A 6/1996 Merrill et a1 6,116,238 A * 9/2000 Jackson et a / A 8/1996 Weg ' 6,193,985 B1 2/2001 Sonne 5,577,497 A 11/1996 Mecikalski ,228,383 B1 5/2001 Hansen B1 5/2001 Fuchs 5,622,163 A 4/1997 JeWett et a1. * - 6,255,502 B1 7/2001 Penkler et ,622,166 4/1997 Elsele et a / A 5/1997 mum 6,274,635 B1 8/2001 Travls A 6/1997 Sha 6 et a1 6,397,838 B1 * 6/2002 Zimlich et a / A 11/1997 purgval et ai 6,608,073 B1 8/2003 Hussain et ,693,608 A 12/1997 Bechgaard B2 8/2003 Wermehng 2003/ A1 4/2003 Wermehng 5,695,743 A 12/1997 Purewal et a1. _. 2003/ A1 6/2003 Wermehng 5,702,725 12/1997 Mernll et a1. _ A 6/1998 Purewal et a1 2003/ A1 8/2003 Wermehng et a A 2/1999 Elkhoury 2003/ A1 11/2003 Wermeling et ,921,237 A * 7/1999 Eisele et a / ,948,389 A 9/1999 Stein * cited by examiner

5 U.S. Patent Sep. 27,2005 Sheet 1 0f 21 US 6,948,492 B2

6 U.S. Patent Se Sheet 2 0f 21 US 6,948,492 B2 M %\ / FIG. 2a FIG. 2b

7 U.S. Patent Sep. 27,2005 Sheet 3 0f 21 US 6,948,492 B u 6 ////////////////////ywwmwww\\\\\\%, h. 7/ / 11 FIG. 3

8 U.S. Patent Sep. 27,2005 Sheet 4 0f 21 US 6,948,492 B2 FIG. 4

9 U.S. Patent Sep. 27,2005 Sheet 5 0f 21 US 6,948,492 B2

10 U.S. Patent Sep. 27,2005 Sheet 6 0f 21 US 6,948,492 B2 [1/ FIG. 6

11 U.S. Patent Sep. 27,2005 Sheet 7 0f 21 US 6,948,492 B ///////2////// k 7/ V///I///7/ / FIG. 7

12 U.S. Patent Sep. 27,2005 Sheet 8 0f 21 US 6,948,492 B2 FIG. 8

13 U.S. Patent Sep. 27,2005 Sheet 9 0f 21 US 6,948,492 B2 FIG. 9

14 U.S. Patent Sep. 27,2005 Sheet 10 0f 21 US 6,948,492 B2

15 U.S. Patent Sep. 27,2005 Sheet 11 0f 21 US 6,948,492 B2

16 U.S. Patent Sep. 27,2005 Sheet 12 0f 21 US 6,948,492 B2 FIG. 12

17 U.S. Patent Sep. 27,2005 Sheet 13 0f 21 US 6,948,492 B2

18 U.S. Patent Sep. 27,2005 Sheet 14 0f 21 US 6,948,492 B2 40 mi; FIG. 14

19

20 U.S. Patent Sep. 27,2005 Sheet 16 0f 21 US 6,948,492 B2 260 FIG. 16

21 U.S. Patent Sep. 27,2005 Sheet 17 0f 21 US 6,948,492 B2 FIG. 17

22 U.S. Patent Sep. 27,2005 Sheet 18 0f 21 US 6,948,492 B2 FIG. 18

23

24

25

26

27

28

29

30

31

32

33

34

35