Devices, systems and methods for medicament delivery

• US 9,149,579 B2
• Filed: 01/24/2013
• Issued: 10/06/2015
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Evan Thomas, Edwards, Eric Shawn, Licata, Mark J.
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/748,728
• Publication Number:
  US 20140031789A1
• Time in Patent Office: 985 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• 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 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• 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 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

An apparatus includes a movable member and a valve coupled to the movable member. The movable member is configured to be disposed within a housing of a medical device and has a first end portion and second end portion. A portion of the first end portion is configured to define a portion of a boundary of a gas chamber. The first end portion defines an opening configured to be in fluid communication between the gas chamber and an area outside the gas chamber. The second end portion is configured to be coupled to a needle configured to deliver a medicament into a body. The valve is configured to selectively allow fluid communication between the gas chamber and the area outside the gas chamber through the opening defined by the first end portion of the movable member.

Claims

1. A method, comprising:

placing an outer housing associated with a medical injector into contact with a body, the outer housing defining a status window and enclosing an inner housing, a piston member, an energy storage member, and an indicator, the piston member at least partially disposed within the inner housing and in contact with an elastomeric member disposed therein, the elastomeric member being in a first position associated with a pre-activation status prior to placing the outer housing into contact with the body, a first indication associated with the pre-activation status being viewable via the status window; and

actuating an actuator to release energy stored in the energy storage member to produce a force to move the piston member, the elastomeric member moving from the first position to a second position in response to movement of the piston member, the indicator configured to move with the piston member from a first indicator position to a second indicator position, the second indicator position being associated with a post-activation status, the indicator providing a second indication associated with the post-activation status viewable via the status window when the indicator is in the second indicator position.

2. The method of claim 1, wherein:

the inner housing is a medicament container containing a medicament; and

the actuating the actuator to move the piston member moves the elastomeric member from the first position to the second position to expel the medicament from the medicament container.

3. The method of claim 1, wherein the first indication includes at least one of the piston member, the elastomeric member, or a contents of the inner housing, the method further comprising:

viewing, before the placing, the first indication via the status window.

4. The method of claim 1, wherein the indicator exposes a colored portion to provide a visual indication associated with the post-activation status when the indicator moves from the first indicator position to the second indicator position.

5. The method of claim 1, wherein:

the inner housing is a medicament container including a medicament, the medicament container at least partially disposed in a carrier;

the first indication including the medicament, the carrier configured such that the medicament is viewable through the status window to indicate the pre-activation status; and

the second indication includes the indicator in the second indicator position, the indicator being spaced apart from the elastomeric member.

6. The method of claim 1, wherein the energy storage member is a gas container storing a compressed gas, the actuating of the actuator includes releasing at least a portion of the compressed gas from the gas container into a gas chamber defined at least in part by the outer housing,

the force associated with the compressed gas released into the gas chamber being sufficient to move at least the piston member in a distal direction, the indicator configured to move with the piston member in a proximal direction.

7. The method of claim 1, wherein:

the placing the outer housing includes placing a contact member movably coupled to a distal end portion of the outer housing in contact with a target surface of the body; and

the indicator spaced apart from the elastomeric member and configured to move from the first position to the second position when the contact member is stationary relative to the outer housing.

8. A method, comprising:

placing an outer housing associated with a medical injector into contact with a body, the outer housing defining a status window and enclosing an inner housing, a piston member, an indicator, and an energy storage member, the piston member configured to move an elastomeric member within the inner housing between a first elastomeric member position and a second elastomeric member position, the elastomeric member being in the first elastomeric member position before the placing such that at least one of a contents of the inner housing or a portion of the piston member is viewable through the status window; and

moving an actuator relative to the outer housing such that the energy storage member produces a force to move the piston member, the elastomeric member moving from the first elastomeric member position to the second elastomeric member position in response to movement of the piston member,

the indicator configured to move with the piston member from a first indicator position to a second indicator position after the actuator is moved, the indicator producing a visual indication when the elastomeric member is in the second elastomeric member position and the indicator is in the second indicator position.

9. The method of claim 8, wherein the indicator is obstructed from view when the indicator is in the first indicator position, the indicator is viewable through the status window when the indicator is in the second indicator position.

10. The method of claim 8, wherein the indicator exposes a colored portion indicating that the actuator has been moved when the indicator is in the second indicator position.

11. The method of claim 8, wherein:

the portion of the piston member moves within the inner housing in a distal direction; and

the indicator moves in a proximal direction within the outer housing between the first indicator position and the second indicator position.

12. The method of claim 8, wherein:

the inner housing is a medicament container, the contents of the medicament container including a medicament; and

the moving the elastomeric member from the first elastomeric member position to the second elastomeric member position expels the medicament from the medicament container.

13. The method of claim 8, wherein the outer housing is the outer housing of an auto-injector, the inner housing is a medicament container, the contents of the medicament container including a medicament, the medicament viewable through the status window when the elastomeric member is in the first elastomeric member position and the indicator is in the first indicator position, the method further comprising:

viewing, before the placing, the medicament via the status window to determine whether the medicament is discolored.

14. The method of claim 8, further comprising:

removing, before the placing, an actuator guard from an end portion of the outer housing, the actuator guard configured to limit movement of the actuator when the actuator guard is coupled to the outer housing.

15. The method of claim 8, wherein the inner housing is a medicament container coupled to a needle, the contents of the medicament container including a medicament, an end portion of the needle being moved from within the outer housing to a needle position outside of the outer housing in response to movement of the piston member, the moving the elastomeric member from the first elastomeric member position to the second elastomeric member position expels the medicament via the needle when the needle is in the needle position outside of the outer housing, the method further comprising:

removing the outer housing from contact with the body after the medicament is expelled, the end portion of the needle being covered by a sheath after the removing.

16. The method of claim 8, wherein the outer housing is the outer housing of an auto-injector, the inner housing is a medicament container coupled to a needle, the contents of the medicament container including a medicament, an end portion of the needle being moved from within the outer housing to a needle position outside of the outer housing in response to movement of the piston member, the moving the elastomeric member from the first elastomeric member position to the second elastomeric member position expels the medicament via the needle when the needle is in the needle position, the method further comprising:

viewing, before the placing, the medicament within the medicament container via the status window to determine whether the medicament is discolored;

removing, before the placing, an actuator guard from an end portion of the outer housing, the actuator guard configured to limit movement of the actuator when the actuator guard is coupled to the outer housing;

viewing, after the moving the actuator, the visual indication produced by the indicator and via the status window; and

removing the outer housing from contact with the body after the medicament is expelled, the end portion of the needle being covered after the removing.

17. A method, comprising:

viewing a contents of a container through a status window defined by a housing associated with a medical injector, the housing enclosing the container, a piston member, an indicator, and an energy storage member, the piston member being at least partially disposed within the container, the viewing occurring when the piston member and the container are in a first configuration and when the indicator is in a first indicator position;

placing a contact member movably coupled to a distal end portion of the housing in contact with a target surface; and

moving an actuator relative to the housing when the contact member is in contact with the target surface to release energy from the energy storage member such that the piston member and the container are moved from the first configuration to a second configuration, the indicator moving from the first indicator position to a second indicator position after the moving the actuator and when the contact member is in a fixed position relative to the housing, the indicator producing a visual indication when the piston member and the container are in the second configuration and the indicator is in the second indicator position.

18. The method of claim 17, wherein the container is in a first container position when the piston member and the container are in the first configuration, the moving the piston member and the container from the first configuration to the second configuration includes moving the container from the first container position to a second container position,

the releasing energy from the energy storage member includes moving the piston member within the container after the container is in the second position to move the elastomeric member from a first elastomeric member position to a second elastomeric member position, the piston member and the container being in the second configuration when the elastomeric member is in the second elastomeric member position.

19. The method of claim 17, wherein the container is a medicament container coupled to a needle, the contents of the medicament container including a medicament, an end portion of the needle being moved from within the housing to a needle position outside of the housing in response to the piston member and the medicament container moving from the first configuration to the second configuration, the piston member configured to move the elastomeric member from a first elastomeric member position to a second elastomeric member position when the piston member and the medicament container move from the first configuration to the second configuration to expel the medicament via the needle when the needle is in the needle position outside of the housing, the method further comprising:

removing the contact member of the housing from contact with the target surface after the medicament is expelled, the end portion of the needle being covered after the removing.

20. The method of claim 19, wherein:

the viewing includes viewing the medicament via the status window to determine whether the medicament is discolored; and

the indicator is spaced apart from the elastomeric member.

21. The method of claim 17, wherein the contents of the container include any one of the piston member or the elastomeric member.