Subcutaneous drug delivery device with improved filling system

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(12) US006186982B1 United States Patent Gross et al. (10) Patent N0.: (45) Date of Patent: US 6,186,982 B1 Feb. 13, 2001 (54) (75) (73) ( * ) (21) (22) (51) (52) (58) (56) SUBCUTANEOUS DRUG DELIVERY DEVICE 5,045,064 9/1991 Idriss .................................. .. 604/132 WITH IMPROVED FILLING SYSTEM 5,098,385 3/1992 Walsh ................................. .. 604/131 5,135,507 8/1992 Haber et al. . 604/187 Inventors: Joseph Gross, Dublin (IE); Zvi Nitzan, * 1698116": elt a1~ - ~ _ - , , ross e a. getagéT?qvi/lgLgfjég?aasizls’ 5,266,013 11/1993 Aubert et al. ...................... .. 417/474 u“ my’, _ _ 5,312,389 5/1994 Theeuwes et al. .............. .. 604/892.1 RazonoYvlFh’ Merl?” Kafn EZFY (IL), 5,324,258 6/1994 Rohrbough . . . . . . . . . . . . .. 604/86 OZ Cablrl; Makablm (IL); _Ha1m _ 5,391,151 2/1995 Wilmot .. 604/139 Damn, Klryat Ono (IL); Gllad Lavl, 5,395,346 3/1995 Maggioni ........................... .. 604/195 Holon (IL) _ _ (List continued on next page.) Assignee: Elan Corporation, plc, Dublin (IE) FOREIGN PATENT DOCUMENTS Notice: Under 35 U.S.C. 154(b), the term of this WO92/11879 7/1992 (WO) ........................... .. A61M/1/08 patent shall be extended for 0 days. _ _ * cited by exammer Appl. N0.: 09/072,875 Primary Examiner—Angela D. Sykes _ Assistant Examiner—Patricia M. Bianco Flled' May 5’ 1998 74 Attorne , A em, or Firm—Kathleen Maher L nch y g y 1111. c1.7 .................................................. .. A61M 37/00 (57) ABSTRACT US‘ Cl‘ """"""" 263946/éi2g76_0:6i9913'16 A subcutaneous drug delivery device having a housing _ / / / ' / having an internal reservoir in communication With a drug Fleld 0f Search ................................ .. 604/19, 48, 23, delivery needle Via a ?uid path~ An expandable Chamber 604/65> 8901’ 8911’ 140’ 141’ 93> 173_174> disposed adjacent to the reservoir forces drug from the 180> 131_133 reservoir to the needle When supplied With a gas. A How R f C, d regulating chamber, in communication With the ?uid path, is e erences lte capable of volumetric changes in response to temperature U_S_ PATENT DOCUMENTS and/or pressure changes. increase in the volume of the How regulatmg chamber increases ?oW resistance to the 471407117 2/1979 B_u°k1§S ct a1~ ~~~~~~~~~~~~~~~~ ~~ 128/213 R needle and thereby counteracts the corresponding increase in 431783928 12/1979 Tlschhnger """ " 128/215 delivery rate resulting from the expansion of the expandable 4’191’181 3/1980 Franetzkl et a1‘ 128013 R chamber due to the same volumetric chan es in res onse to 4 196 732 4/1980 Wardlaw 128/218 g p 4,258,713 3/1981 Wardlaw 128/218 temperature and/Or Pressure' 4,640,445 2/1987 Yamada .... .. . 222/3865 _ _ _ _ 4,684,367 8/1987 schaffer 604/140 The device also mcludes an improved ?llmg system that 4,687,423 8/1987 Maget er a1, 417/379 enables the reservoir Within the device to be ?lled With drug 4,734,092 3/1988 Millerd ................................. .. 604/67 from a source Without regard to ?lling position and With a 4,753,651 6/1988 Eckenhoff .......................... .. 424/449 decreased risk of injury from need1e5_ Moreover, the ?lling 477587226 7/1988 Cane ~~~~~~~~~~~~ ~~ 604/141 system provides an accurate measure of drug transferred into 1g; gf’nlrllfmtetlal' the device thus enabling patients to ?ll the devices and to 1re 1 e a . ~ 479027278 2/1990 Maget et al. ....................... .. 604/132 ensure proper dosage upon dehvery' 5,024,656 6/1991 Gasaway et al. .................... .. 604/70 5,024,661 6/1991 Wender et al. .................... .. 604/110 7 Claims, 29 Drawing Sheets 10 20 26 32 13 11 as 34 19 T 28 / / 24 23 25 \ 1_2 / 31 § _ /1/ / ?/s/ . 1\4 1\6 38 33 15 Y 29’ 27 _ 29 17 4s 29 1s 30 22 21

Transcript of Subcutaneous drug delivery device with improved filling system

(12)

US006186982B1

United States Patent Gross et al.

(10) Patent N0.: (45) Date of Patent:

US 6,186,982 B1 Feb. 13, 2001

(54)

(75)

(73)

( * )

(21) (22)

(51) (52)

(58)

(56)

SUBCUTANEOUS DRUG DELIVERY DEVICE 5,045,064 9/1991 Idriss .................................. .. 604/132 WITH IMPROVED FILLING SYSTEM 5,098,385 3/1992 Walsh ................................. .. 604/131

5,135,507 8/1992 Haber et al. . 604/187

Inventors: Joseph Gross, Dublin (IE); Zvi Nitzan, * 1698116": elt a1~ - ~ _ - , , ross e a. getagéT?qvi/lgLgfjég?aasizls’ 5,266,013 11/1993 Aubert et al. ...................... .. 417/474

u“ my’, ’ _ _ 5,312,389 5/1994 Theeuwes et al. .............. .. 604/892.1

RazonoYvlFh’ Merl?” Kafn EZFY (IL), 5,324,258 6/1994 Rohrbough . . . . . . . . . . . . .. 604/86

OZ Cablrl; Makablm (IL); _Ha1m _ 5,391,151 2/1995 Wilmot .. 604/139 Damn, Klryat Ono (IL); Gllad Lavl, 5,395,346 3/1995 Maggioni ........................... .. 604/195 Holon (IL) _ _

(List continued on next page.)

Assignee: Elan Corporation, plc, Dublin (IE) FOREIGN PATENT DOCUMENTS

Notice: Under 35 U.S.C. 154(b), the term of this WO92/11879 7/1992 (WO) ........................... .. A61M/1/08 patent shall be extended for 0 days. _ _

* cited by exammer

Appl. N0.: 09/072,875 Primary Examiner—Angela D. Sykes _ Assistant Examiner—Patricia M. Bianco

Flled' May 5’ 1998 74 Attorne , A em, or Firm—Kathleen Maher L nch y g y

1111. c1.7 .................................................. .. A61M 37/00 (57) ABSTRACT

US‘ Cl‘ """"""" 263946/éi2g76_0:6i9913'16 A subcutaneous drug delivery device having a housing _ / ’ / ’ / ' ’ / having an internal reservoir in communication With a drug

Fleld 0f Search ................................ .. 604/19, 48, 23, delivery needle Via a ?uid path~ An expandable Chamber 604/65> 8901’ 8911’ 140’ 141’ 93> 173_174> disposed adjacent to the reservoir forces drug from the

180> 131_133 reservoir to the needle When supplied With a gas. A How R f C, d regulating chamber, in communication With the ?uid path, is e erences lte capable of volumetric changes in response to temperature

U_S_ PATENT DOCUMENTS and/or pressure changes. increase in the volume of the How regulatmg chamber increases ?oW resistance to the

471407117 2/1979 B_u°k1§S ct a1~ ~~~~~~~~~~~~~~~~ ~~ 128/213 R needle and thereby counteracts the corresponding increase in 431783928 12/1979 Tlschhnger """ " 128/215 delivery rate resulting from the expansion of the expandable 4’191’181 3/1980 Franetzkl et a1‘ 128013 R chamber due to the same volumetric chan es in res onse to 4 196 732 4/1980 Wardlaw 128/218 g p 4,258,713 3/1981 Wardlaw 128/218 temperature and/Or Pressure' 4,640,445 2/1987 Yamada .... .. . 222/3865 _ _ _ _

4,684,367 8/1987 schaffer 604/140 The device also mcludes an improved ?llmg system that 4,687,423 8/1987 Maget er a1, 417/379 enables the reservoir Within the device to be ?lled With drug 4,734,092 3/1988 Millerd ................................. .. 604/67 from a source Without regard to ?lling position and With a 4,753,651 6/1988 Eckenhoff .......................... .. 424/449 decreased risk of injury from need1e5_ Moreover, the ?lling 477587226 7/1988 Cane ~~~~~~~~~~~~ ~~ 604/141 system provides an accurate measure of drug transferred into

1g; gf’nlrllfmtetlal' the device thus enabling patients to ?ll the devices and to 1re 1 e a . ~

479027278 2/1990 Maget et al. ....................... .. 604/132 ensure proper dosage upon dehvery'

5,024,656 6/1991 Gasaway et al. .................... .. 604/70 5,024,661 6/1991 Wender et al. .................... .. 604/110 7 Claims, 29 Drawing Sheets

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20

26 32 13 11 as 34 ‘ 19

T 28 / / 24 23

25 \

1_2 /

31

§ _ /1/ / ?/s/

. 1\4 1\6 38 33 15 Y 29’ 27 _ 29 17 4s 29 1s 30

22 21

US 6,186,982 B1 Page 2

US. PATENT DOCUMENTS 5,693,018 * 12/1997 Kriesel et a1. ..................... .. 604/132 * .

573957501 3/1995 Rohrbacker et a1‘ __________ " 204/265 5,700,244 * 12/1997 Knesel ............................... .. 604/132

575277288 @1996 GrossetaL 604/140 5,704,520 1/1998 Gross ................................. .. 604/141

5545143 8/1996 Fischell _____ __ 604/180 5,741,242 * 4/1998 Kriesel ............................... .. 604/403

5,562,624 10/1996 Righi et 81.. 604/110 5,785,688 7/1998 1651116181. ......................... .. 604/141

272122; Z133; gleyer 6‘ ‘*1- 28312132 5,814,020 * 9/1998 Gross ................................... .. 604/41 , , ewman .

576247401 4/1997 Leijd 6O4/11O 5,840,071 * 11/1998 Knesel et a1. ..................... .. 604/132

5,637,092 6/1997 Shaw .................................. .. 604/110 5,931,814 * 8/1999 Alex etal- ------------------------- -- 604/131

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