IP Library › Granted Patent US 12,268,847
Granted Patent B1
US 12,268,847 · App. 17/668,228 · Granted Apr 8, 2025

Devices and methods for delivery of substances within a medicament container

Inventors: Paul F. Meyers (Fishers, IN); Michael J. Roe (Powhatan, VA)
Assignee: kaleo, Inc.
A61M5/2046A61M5/31548A61M5/3158A61M5/322A61M5/2053A61M2005/2093
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Quick Facts
Patent No.
US 12,268,847
App. No.
17/668,228
Granted
Apr 8, 2025
Kind
B1
Abstract

An apparatus includes a housing, an energy storage member, a carrier, a medicament container, and a delivery control mechanism. The housing defines a gas chamber configured to receive pressurized gas from the energy storage member to pressurize the gas chamber. The carrier has a proximal surface that defines a portion of the gas chamber. The medicament container is coupled to the carrier and has a distal end portion coupled to a delivery member. The medicament container contains at least 5 mL of medicament and includes an elastomeric member that seals the medicament within the medicament container. The delivery control mechanism is coupled to a proximal end portion of the medicament container and includes a flow restriction member for regulating a pressure supplied by the gas chamber and entering into the medicament container that acts on the elastomeric member.

Claims (79)

1. A method of delivering a dose of a composition, comprising:

actuating a medical injector via a system actuation assembly such that an energy storage member produces a force via a compressed gas within an internal volume of a housing of the medical injector on a container containing a dose of the composition, the force causing the container to move within the housing to cause a needle to extend from the housing, the movement of the container compressing a retraction spring of the medical injector;

regulating, via a control assembly positioned within the housing, a portion of the force applied on an elastomeric member to cause a movement of the elastomeric member within the container to deliver an initial portion of the dose;

initiating a venting of the internal volume via a vent opening defined by the housing, the vent opening being sized to maintain the force produced by the compressed gas acting on the container at a magnitude that is greater than a force applied to the container by the retraction spring during a time to deliver a final portion of the dose, the force produced by the compressed gas decreasing to a magnitude that is less than the force applied by the retraction spring concurrent with the delivery of the final portion of the dose; and

retracting the needle via a movement of the container within the housing in response to the force applied by the retraction spring.

2. The method of claim 1 , wherein:

the control assembly includes a gas vent assembly;

the gas vent assembly includes a valve configured to selectively place the internal volume of the housing in fluid communication with an exterior volume surrounding the housing; and

initiating the venting of the internal volume includes actuating the valve.

3. The method of claim 2 , wherein:

the gas vent assembly includes a valve actuator; and

actuating the valve includes manually actuating the valve actuator.

4. The method of claim 2 , wherein:

the vent opening is sized to establish a venting duration of at least 0.5 seconds and less than 1.5 seconds; and

the venting duration commences with the actuation of the valve of the gas vent assembly and culminating with the delivery of the final portion of the dose.

5. The method of claim 2 , wherein:

the vent opening is sized to establish a venting duration of at least 5 seconds and less than or equal to 15 seconds; and

the venting duration commences with the actuation of the valve of the gas vent assembly and culminating with the delivery of the final portion of the dose.

6. The method of claim 1 , wherein:

the control assembly regulates the portion of the force to cause a first 20% of the dose to dispense over a first time duration and to cause a last 20% of the dose to be disposed over a second time duration; and

the second time duration is less than two times the first time duration.

7. The method of claim 6 , wherein:

the second time duration is less than about 1.5 times the first time duration.

8. The method of claim 1 , wherein:

the medical injector is a wearable delivery device maintained in position against a portion of a body via an attachment surface; and

the attachment surface is configured to maintain the position absent a manually applied pressure by a user.

9. The method of claim 8 , wherein:

the needle extends at an angle of between 75 degrees to 88 degrees relative to a longitudinal plane of the wearable delivery device.

10. The method of claim 8 , wherein:

the attachment surface is secured against the portion of the body via at least one of an adhesive surface, a strap, a band, a sleeve, or a bandage.

11. A method of delivering a dose of a composition, comprising:

actuating a medical injector such that an energy storage member produces a force via a compressed gas within an internal volume of a housing of the medical injector on a container containing a dose of the composition, the force causing the container to move within the housing to cause a needle to extend from the housing, the movement of the container compressing a retraction spring of the medical injector;

regulating, via a control assembly positioned within the housing, a portion of the force applied directly on an elastomeric member positioned within the container to cause a movement of the elastomeric member within the container to deliver an initial portion of the dose, the medical injector having an absence of a piston coupled to the elastomeric member to cause a movement thereof;

initiating a venting of the internal volume via a vent opening defined by the housing, the vent opening being sized to maintain the force produced by the compressed gas acting on the container at a magnitude that is greater than a force applied to the container by the retraction spring during a time to deliver a final portion the dose, the force produced by the compressed gas decreasing to a magnitude that is less than the force applied by the retraction spring concurrent with the delivery of the final portion of the dose; and

retracting the needle via a movement of the container within the housing in response to the force applied by the retraction spring.

12. The method of claim 11 , wherein:

the control assembly includes a gas vent assembly;

the gas vent assembly includes a valve;

the gas vent assembly is configured to selectively place the internal volume of the housing in fluid communication with an exterior volume surrounding the housing; and

initiating the venting of the internal volume includes actuating the valve.

13. The method of claim 12 , wherein:

the gas vent assembly includes a valve actuator; and

actuating the valve includes manually actuating the valve actuator.

14. The method of claim 12 , wherein:

the vent opening is sized to establish a venting duration of at least 0.5 seconds and less than 1.5 seconds; and

the venting duration commences with the actuation of the valve of the gas vent assembly and culminating with the delivery of the final portion of the dose.

15. The method of claim 12 , wherein:

the vent opening is sized to establish a venting duration of at least 5 seconds and less than 15 seconds; and

the venting duration commences with the actuation of the valve of the gas vent assembly and culminating with the delivery of the final portion of the dose.

16. The method of claim 11 , wherein:

the control assembly regulates the portion of the force to cause a first 20% of the dose to dispense over a first time duration and to cause a last 20% of the dose to be disposed over a second time duration; and

the second time duration is less than two times the first time duration.

17. The method of claim 16 , wherein:

the second time duration is less than about 1.5 times the first time duration.

18. The method of claim 11 , wherein:

actuating the medical injector includes placing the medical injector against a body such that a longitudinal axis of the needle is positioned at an angle of between about 75 degrees to 105 degrees relative to an injection surface of the body.

19. The method of claim 11 , wherein:

regulating the portion of the force applied directly on the elastomeric member includes reducing the force applied directly on the elastomeric member relative to the force applied to the container.

20. The method of claim 11 , wherein:

the housing defines a first gas chamber;

a distal end portion of the control assembly defines a first portion of a boundary of a second gas chamber;

a proximal end portion of the elastomeric member within the container defines a second portion of the boundary of the second gas chamber; and

the control assembly is configured to permit pressurized gas to pass from the first gas chamber into the second gas chamber at a reduced pressure on a condition that the needle is extended from the housing.

21. A method of delivering a dose of a composition, comprising:

actuating a medical injector such that an energy storage member produces a force via a first portion of compressed gas within a first gas chamber defined by a housing of the medical injector, the force of the first portion of compressed gas acting on a container containing a dose of the composition, the force causing the container to move within the housing to cause a needle to extend from the housing, the movement of the container compressing a retraction spring of the medical injector;

regulating, via a control assembly positioned within the housing, a flow of a second portion of gas from the first gas chamber into a second gas chamber to act directly on an elastomeric member positioned within the container, the second gas chamber being defined at least in part by the control assembly, the container, and the elastomeric member such that at least a portion of the second gas chamber is within the container, the second portion of gas within the second gas chamber applying a force directly on the elastomeric member to cause a movement of the elastomeric member within the container to deliver an initial portion of the dose;

initiating a venting of the first gas chamber via a vent opening defined by the housing, the vent opening being sized to maintain the force produced by the first portion of the compressed gas acting on the container at a magnitude that is greater than a force applied to the container by the retraction spring during a time to deliver a final portion the dose, the force produced by the first portion of the compressed gas decreasing to a magnitude that is less than the force applied by the retraction spring concurrent with the delivery of the final portion of the dose; and

retracting the needle via a movement of the container within the housing in response to the force applied by the retraction spring.

22. The method of claim 21 , wherein:

the control assembly is configured to permit the second portion of pressurized gas to pass from the first gas chamber into the second gas chamber at a reduced pressure on a condition that the needle is extended from the housing.

23. The method of claim 21 , wherein:

the first portion of pressurized gas is at a first pressure within the first gas chamber;

the second portion of pressurized gas is at a second pressure within the second gas chamber; and

the second pressure is less than the first pressure.

24. The method of claim 21 , wherein:

the medical injector has an absence of a piston positioned to affect the elastomeric member.

25. The method of claim 21 , wherein:

the control assembly regulates a pressure of the second portion of gas within the second gas chamber to cause a first 20% of the dose to dispense over a first time duration and to cause a last 20% of the dose to disposed over a second time duration; and

the second time duration is less than two times the first time duration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 9, 2022
From: MEYERS, PAUL F.; ROE, MICHAEL J.
To: KALEO, INC.
Reel/Frame 059873/0625 →
Continuity (1)
Provisional Application 63147785 · Feb 10, 2021
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