IP Library Granted Patent US 11,154,684
Granted Patent B2
US 11,154,684 · App. 15/899,063 · Granted Oct 26, 2021

Devices and methods for engaging indexed valve and pressurized canister assembly with collar and for linear actuation by plunger assembly into fluid communication with device for regulating drug delivery

Inventors: Frederick J. Montgomery (Sun Prairie, WI); Duncan P. Bathe (Fitchburg, WI); Daniel J. Lee (Monticello, WI); Scott I. Biba (Highland, WI); Todd J. Bakken (Madison, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M16/14A61B90/90A61B90/94A61B90/98A61M16/12A61M16/20A61M16/209F17C13/003F17C13/04A61M2202/0208A61M2202/0233A61M2202/0266A61M2202/0275A61M2205/6045A61M2205/6054F17C2201/0104F17C2201/0109F17C2201/032F17C2201/058F17C2205/0153F17C2205/0188F17C2205/0323F17C2205/0382F17C2205/058F17C2221/014F17C2221/031F17C2223/013F17C2223/0123F17C2260/028F17C2270/02F17C2270/025
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Quick Facts
Patent No.
US 11,154,684
App. No.
15/899,063
Granted
Oct 26, 2021
Kind
B2
Abstract

A valve assembly having a housing and a valve, the valve being disposed within the housing, a first indexed member integral to the housing, the first indexed member adapted to be complementary to a second indexed member, and a radio frequency identification device adapted to communicate with a radio frequency receiver, the valve being configured to align with a canister, seal the canister and open in a single movement. A drug containment device having said valve assembly is also disclosed.

Claims (47)

1. A drug containment device, comprising:

a canister containing a therapeutic gas;

a housing and a valve operatively coupled with the canister, at least a portion of the valve being disposed within the housing and configured for regulating flow of the therapeutic gas from the canister when actuated along a longitudinal axis of the canister; and

an indexed member integral to the housing and adapted to engage a complementarily indexed member of a gas delivery and regulation apparatus when aligned therewith via a single relative movement that is perpendicular to the longitudinal axis so as to enable the drug containment device to be aligned with and secured to the gas delivery and regulation apparatus in a manner that provides sufficient engagement for actuation of the valve.

2. The drug containment device of claim 1 , wherein the therapeutic gas comprises an active pharmaceutical ingredient and an inactive carrier gas.

3. The drug containment device of claim 2 , wherein the inactive carrier gas comprises at least one of N 2 and O 2 , and wherein the active pharmaceutical ingredient comprises at least one of (i) nitric oxide, with a concentration in the range of approximately 50 ppm to 10,000 ppm, (ii) carbon monoxide, with a concentration in the range of approximately 500 ppm to 20,000 ppm, and (iii) a chalcogenide compound.

4. The drug containment device of claim 1 , wherein the valve comprises a spring biased needle valve.

5. The drug containment device of claim 1 , wherein the indexed member comprises a first arcuate opening and a second arcuate opening that extend arcuately about, and on at least a portion of opposing sides of, the longitudinal axis of the canister, the first and second arcuate openings having at least one of different axial widths or misaligned mid-planes.

6. The drug containment device of claim 5 , wherein the first arcuate opening is directly opposite from the second arcuate opening.

7. The drug containment device of claim 6 , wherein the first and second arcuate openings have both different axial widths and misaligned mid-planes.

8. The drug containment device of claim 1 , wherein the indexed member is configured to be a support enabling the canister to be suspended vertically.

9. The drug containment device of claim 2 , wherein indexed member is configured to be a support permitting actuation of the valve along the longitudinal axis of the canister.

10. A drug delivery system, comprising:

the drug containment device of claim 1 , and

a therapeutic gas delivery and regulation apparatus, the therapeutic gas delivery and regulation apparatus comprising the complementary indexed member.

11. The drug delivery system of claim 10 , wherein the drug containment device is removable from the therapeutic gas delivery and regulation apparatus via a relative movement that is perpendicular to the longitudinal axis.

12. The drug delivery system of claim 10 , wherein one or both of the indexed member and the complementary indexed member has a respective surface configured as a support enabling the drug containment device to be seated in the drug delivery and regulation device and permitting actuation of the valve along the longitudinal axis of the canister.

13. A drug containment device, comprising:

a canister having a valve configured for regulating flow of a therapeutic gas contained in the canister via actuation of the valve along a longitudinal axis of the canister; and

a housing encasing at least a portion of the valve and having an indexed member adapted to engage a complementarily indexed member of a therapeutic gas delivery and regulation apparatus when aligned therewith via a single relative movement that is perpendicular to the longitudinal axis of the canister to thereby ensure the canister is an authorized canister type, and enable the drug containment device to be aligned with and secured to the therapeutic gas delivery and regulation apparatus in a manner that provides sufficient engagement for actuation of the valve.

14. The drug containment device of claim 13 , wherein the indexed member comprises a first arcuate opening and a second arcuate opening that extend arcuately about, and on at least a portion of opposing sides of, the longitudinal axis of the canister, the first and second arcuate openings having at least one of different axial widths or misaligned mid-planes.

15. The drug containment device of claim 14 , wherein the first arcuate opening is directly opposite from the second arcuate opening, and wherein the first and second arcuate openings have both different axial widths and misaligned mid-planes.

16. The drug containment device of claim 13 , wherein the indexed member is configured to be a support enabling the canister to be suspended vertically and permitting actuation of the valve along the longitudinal axis of the canister.

17. A drug delivery system, comprising:

the drug containment device of claim 13 , and

a therapeutic gas delivery and regulation apparatus, the therapeutic gas delivery and regulation apparatus comprising the complementary indexed member.

18. The therapeutic gas delivery system of claim 17 , wherein the drug containment device is removable from the therapeutic gas delivery and regulation apparatus via a relative movement that is perpendicular to the longitudinal axis.

19. The drug delivery system of claim 17 , wherein one or both of the indexed member and the complementary indexed member has a respective surface configured as a support enabling the drug containment device to be seated in the drug delivery and regulation device and permitting actuation of the valve along the longitudinal axis of the canister.

20. An indexed drug containment device for an indexed drug actuation device for use in an indexed drug delivery and regulation device, the indexed drug containment device comprising:

a valve assembly comprising a housing and a valve, the valve disposed within the housing,

a gas canister in fluid communication with the valve, the canister containing an active pharmaceutical ingredient and an inactive gas carrier, the canister being aligned along a longitudinal axis, the valve being axially actuatable along the longitudinal axis,

a first indexed member integral to the housing and a third indexed member integral to the housing, the first indexed member adapted to be complementary to a second indexed member integral to a collar of the indexed drug actuation device, the second indexed member being a first key, the third indexed member adapted to be complementary to a fourth indexed member integral to the collar of the indexed drug actuation device, the fourth indexed member being a second key, wherein the first indexed member is non-complementary to the fourth indexed member, and wherein the third indexed member is non-complementary to the second indexed member,

wherein the first indexed member is a first opening disposed on one side of the housing and the third indexed member is a second opening disposed on an opposite side of the housing with respect to the longitudinal axis of the gas canister,

wherein the housing is engageable by the collar of the indexed drug actuation device in a direction perpendicular to the longitudinal axis,

wherein one or more of the first and third indexed members are predeterminately adapted to indicate the identity of the active pharmaceutical ingredient, wherein indexing features that correspond to the identity of the active pharmaceutical ingredient are provided by one or more of different axial widths, axial juxtaposition, or different cross-sectional shapes of such that the indexed collar engages only the indexed drug containment device, whereby the indexing provides fully complementary members identified for the predetermined active pharmaceutical ingredient and/or dosing concentration wherein indexing features that correspond to the identity of the active pharmaceutical ingredient are provided by one or more of different axial widths, axial juxtaposition, or different cross-sectional shapes of interfaces formed by engagement of the first indexed member with the second indexed member and the engagement of the third indexed member with the fourth indexed member.

21. The indexed drug containment device of claim 20 , wherein the indexed drug containment device comprises a plurality of indexed members, each indexed member adapted to be complementary to a corresponding indexed member and non-complementary to a non-corresponding indexed member.

22. The indexed drug containment device of claim 21 , wherein:

the active pharmaceutical ingredient comprises nitric oxide, the inactive carrier gas comprises N2, and, the canister concentration is in the range of approximately 50 ppm to 10,000 ppm,

the active pharmaceutical ingredient comprises carbon monoxide, the inactive carrier gas comprises O2, and, the canister concentration is in the range of approximately 500 ppm to 20,000 ppm, or,

the active pharmaceutical ingredient is a chalcogenide compound at a suitable concentration.

23. The indexed drug containment device of claim 20 , wherein the first and second openings are selected from a groove, slot, channel, aperture or hole, and the first and second keys are selected from a tongue, prong, post, ridge, protrusion or rail.

24. The indexed drug containment device of claim 20 , wherein the valve assembly is threaded to the canister.

25. The indexed drug containment device of claim 20 , further comprising a radio frequency identification device adapted to communicate with a radio frequency receiver.

26. The indexed drug containment device of claim 25 , wherein the radio frequency identification device is disposed about a neck of the canister.

27. An indexed drug actuation device for use in an indexed drug delivery and regulation device comprising:

the indexed drug containment device of claim 20 , and

a collar, the collar comprising a second indexed member being a first key and a fourth indexed member being a second key, the first indexed member of the indexed drug containment device being adapted to be complementary to the second indexed member of the collar, the third indexed member of the indexed drug containment device adapted to be complementary to a fourth indexed member of the collar, wherein the first indexed member is non-complementary to the fourth indexed member, and wherein the third indexed member is non-complementary to the second indexed member, wherein the second indexed member and the fourth indexed member are integral to the collar.

Assignments (12)
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049822, FRAME 0674 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065609/0454 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jul 22, 2019
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049822/0674 →