Drug delivery systems and methods

• US 6,723,068 B2
• Filed: 09/23/2002
• Issued: 04/20/2004
• Est. Priority Date: 11/13/1998
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Ygal, Gil, Tsals, Israil, Gross, Joseph
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US10/252,336
• Publication Number:
  US 20030023203A1
• Time in Patent Office: 575 Days
• Field of Search: 604/191, 604/82, 604/181, 604/182, 604/187, 604/9.01, 604/156-157, 604/192, 604/194, 604/198-201, 604/203-205, 604/220, 604/233, 604/232, 604/234
• US Class Current: 604/82
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3223 Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2205/215 Tilt detection, e.g. for warning or shut-off
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3234 : Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user

Abstract

The present invention relates to a drug delivery device for mixing and delivering a drug by injection. The device includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetrating membrane such as a needle is used to inject the drug into a patient which is in fluid communication with the first container. The needle is movable from a storage position in the housing to an injection position extending through the housing.

Claims

1. A fluid injection device comprising:

a housing having a penetrating member aperture;

a first port in said housing that receives a first container that contains a solid compound for injection;

a second port in said housing that receives a second container that contains a fluid to be mixed with the solid compound in the first container to form a reconstituted drug to be transferred from the first container;

a first channel that provides fluid communication between the first and second containers;

a first penetrating member movable from a storage position in the housing to an injection position extending outside the housing through the aperture;

a mixing device that mixes said fluid with said solid compound, said mixing device comprising;

a second penetrating member fixed to said housing and that penetrates said second container;

a third penetrating member fixed to said housing and that penetrates said first container, said second and third penetrating members being in fluid communication with each other via said first channel; and

a compression element in said housing that displaces the fluid in said second container; and

a fourth penetrating member positioned within said housing and that penetrates said second container; and

a second channel that fluidly connects said first and said fourth penetrating members.

2. The device of claim 1 further comprising a handle member pivotally attached to said housing and that actuates said fourth penetrating member to penetrate said first container.

3. A method of fluid injection comprising the steps of:

providing a housing member having a penetrating member aperture;

providing a first port in said housing that receives a first container that contains a solid compound for injection;

providing a first penetrating member fixed to said housing and configured to penetrate said first container;

inserting a first container in said housing;

providing a second port in said housing that receives a second container that contains a fluid to be mixed with the solid compound to form an injectable fluid;

providing a second penetrating member fixed to said housing and configured to penetrate said second container;

inserting a second container in said housing;

providing a first channel in fluid communication between the first and second containers;

fluidly connecting said first and second penetrating members via said first channel;

providing a third penetrating member that is movable between a storage position within said housing and an injection position outside said housing via said penetrating member aperture;

providing a fourth penetrating member positioned within said housing and configured to penetrate said second container when displaced;

fluidly connecting said first and fourth penetrating members via a second channel;

displacing said third and fourth penetrating member; and

injecting said injectable fluid at an injection site with said third penetrating member extending through said penetrating member aperture and into the injection site.

4. The method of claim 3 further comprising the step of biasing said third penetrating member in the storage position.