Devices, systems and methods for medicament delivery

• US 9,278,182 B2
• Filed: 03/20/2015
• Issued: 03/08/2016
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Weinzierl, David A.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US14/664,426
• Publication Number:
  US 20150190591A1
• Time in Patent Office: 354 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• 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 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• 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 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• 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
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

An apparatus includes a label configured to be coupled to a medicament delivery device. The label includes a first surface and a second surface. The first surface is configured to be coupled to an outer surface of the medicament delivery device. The second surface includes a textual indicia. The label further includes an electronic circuit system configured to output an electronic signal.

Claims

1. An apparatus, comprising:

a housing defining a cavity configured to receive a medicament container, the medicament container containing a medicament, the medicament container coupled to a needle that is disposed within a lumen of a needle sheath;

a delivery mechanism disposed within the housing, the delivery mechanism configured to produce a force to move the medicament container within the housing from a first container position to a second container position and to deliver the medicament from the medicament container to a target location when the medicament container is in the second container position within the cavity of the housing, the needle being disposed within the housing when the medicament container is in the first container position, the needle being disposed through an opening defined by the housing when the medicament container is in the second container position;

a contact member coupled to a distal end portion of the housing, the contact member including a contact surface configured to contact the target location, the contact member configured to move relative to the distal end portion of the housing from a first position to a second position;

a retraction mechanism configured to retract the needle after delivery of the medicament such that the needle is disposed within the housing when the needle is retracted; and

an electronic circuit system coupled to the housing, the electronic circuit system configured to output a first light output when the needle sheath is removed from about the needle such that the needle is outside of the lumen of the needle sheath, the electronic circuit system configured to output a second light output when the contact member moves from the first position to the second position.

2. The apparatus of claim 1, wherein:

the electronic circuit system includes a switch operably coupled to a start button such that the start button actuates the switch when the start button is actuated, the electronic circuit system configured to output a third light output when the switch is actuated.

3. The apparatus of claim 2, wherein:

the start button is disposed at a proximal end portion of the housing.

4. The apparatus of claim 1, wherein

the needle sheath is removable from about the needle via the opening of the housing.

5. The apparatus of claim 4, wherein:

the needle sheath is configured to limit movement of the contact member relative to the housing when the needle is disposed within the lumen of the needle sheath,

the contact member configured to move towards the distal end portion of the housing when the contact member is placed in contact with the target location after the needle sheath is removed from about the needle.

6. The apparatus of claim 4, wherein the retraction mechanism includes a spring.

7. The apparatus of claim 1, wherein the needle sheath is configured to limit movement of the contact member when at least a proximal end portion of the needle sheath is disposed within the housing and the needle is disposed within the lumen of the needle sheath.

8. The apparatus of claim 1, wherein the needle sheath is configured to limit movement of the contact member relative to the housing when at least a proximal end portion of the needle sheath is within the housing and the needle is within the lumen of needle sheath, the contact member configured to move towards the distal end portion of the housing when the contact member is placed in contact with the target location after the needle sheath assembly is removed from about the needle, the apparatus further comprising:

a sheath remover including a protrusion configured to exert a force against a shoulder of the needle sheath to remove the needle sheath from about the needle.

9. The apparatus of claim 1, wherein the retraction mechanism includes a release member configured to release the force from at least one of the medicament container or the needle to allow retraction of the needle.

10. An apparatus, comprising:

a housing configured to receive a medicament container, the medicament container coupled to a needle, the needle disposed within and coupled to a needle sheath;

a delivery mechanism disposed within the housing, the delivery mechanism configured to produce a force to move the medicament container within the housing such that an end portion of the needle is outside of the housing, the delivery mechanism configured to deliver a medicament from the medicament container when the end portion of the needle is outside of the housing;

a retraction assembly configured to retract the needle after delivery of the medicament such that the needle is disposed entirely within the housing;

a contact member coupled to a distal end portion of the housing, the contact member including a contact surface configured to contact a target location, the contact member configured to move proximally relative to the distal end portion of the housing the housing when the contact surface is pressed against the target location, the contact member configured such that movement of the contact member relative to the housing is limited by the needle sheath when the needle is within the needle sheath; and

an electronic circuit system coupled to the housing, the electronic circuit system configured to output a first light output when the contact member moves proximally relative to the housing, the electronic circuit system configured to output a second light output after the retraction assembly retracts the needle.

11. The apparatus of claim 10, wherein:

the electronic circuit system includes a switch operably coupled to a start button such that the start button actuates the switch when the start button is actuated, the electronic circuit system configured to output a third light output when the switch is actuated.

12. The apparatus of claim 10, wherein:

the medicament container is configured to move within the housing from a first container position to a second container position in response to the force produced by the delivery mechanism;

the end portion of the needle is disposed within the housing when the medicament container is in the first container position, the needle disposed through an opening defined by the distal end portion of the housing when the medicament container is in the second container position; and

the needle sheath being removed from about the needle via the opening of the housing.

13. The apparatus of claim 10, wherein:

when the medicament container is received within the housing at least a proximal end portion of the needle sheath is disposed within the housing and the needle is disposed within a lumen of the needle sheath; and

the electronic circuit system configured to output a third light output when the needle sheath is removed from about the needle.

14. The apparatus of claim 10, further comprising:

the medicament container movably disposed within a cavity of the housing, the needle disposed within the housing when the medicament container is in a first container position, the needle disposed through an opening defined by the distal end portion of the housing when the medicament container is in a second container position.

15. The apparatus of claim 10, wherein:

when the medicament container is received within the housing at least a proximal end portion of the needle sheath is disposed within the housing and the needle is disposed within a lumen of the needle sheath;

the electronic circuit system includes a switch operably coupled to a start button such that the start button actuates the switch when the start button is manipulated, the electronic circuit system configured to output a third light output when the switch is actuated; and

the electronic circuit system is configured to output a fourth light output when the when the needle sheath is removed from about the needle.

16. The apparatus of claim 10, wherein the retraction assembly includes a release member and a spring, the release member configured to release the force from at least one of the medicament container or the needle, the spring configured to urge the needle to move proximally relative to the housing.

17. An apparatus, comprising:

a housing configured to receive a medicament container, the medicament container containing a medicament, the medicament container coupled to a needle that is disposed within a lumen of a needle sheath;

a sheath remover including a protrusion configured to exert a force against a shoulder of the needle sheath to remove the needle sheath from about the needle;

a delivery mechanism disposed within the housing, the delivery mechanism configured to produce a force to transition the medicament container from a first container position to a second container position after the needle sheath is removed from the needle such that the medicament is delivered from the medicament container via the needle, the needle being disposed within the housing when the medicament container is in the first container position, the needle disposed through an opening defined by the housing when the medicament container is in the second container position;

a contact member coupled to the housing, the contact member configured to move relative to the housing from a first position to a second position, the contact member including a contact surface configured to contact a target location;

a retraction mechanism including a release member configured to release the force from at least one of the medicament container or the needle to allow retraction of the needle after delivery of the medicament such that the needle is disposed within the housing when the needle is retracted; and

an electronic circuit system coupled to the housing, the electronic circuit system configured to output to output a first electronic output when the needle sheath is removed from the needle via the sheath remover, the electronic circuit system configured to output a second electronic output when the medicament container is in the first container position and the contact member is in the second position, the electronic circuit system configured to output a third electronic output when the medicament container is in the second container position.

18. The apparatus of claim 17, wherein:

the electronic circuit system includes a switch operably coupled to a start button such that the start button actuates the switch when the start button is actuated, the electronic circuit system configured to output a light output when the switch is actuated.

19. The apparatus of claim 17, wherein:

the needle sheath is removable from about the needle via the opening of the housing.

20. The apparatus of claim 19, wherein:

the needle sheath is configured to limit movement of the contact member relative to the housing when at least a proximal end portion of the needle sheath is disposed within the housing and the needle is disposed within the lumen of the needle sheath.

21. The apparatus of claim 19, wherein the retraction mechanism includes a spring configured to urge the needle in a proximal direction.