Medicament delivery device and methods for delivering drugs to infants and children

• US 10,688,244 B2
• Filed: 12/21/2017
• Issued: 06/23/2020
• Est. Priority Date: 12/23/2016
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Kelley, Glen L., Meyers, Paul F.
• Primary Examiner(s): Lee, Brandy S
• Assistant Examiner(s): Hussain, Nidah M
• Application Number:
  US16/071,203
• Publication Number:
  US 20190358399A1
• Time in Patent Office: 915 Days
• Field of Search: 604131
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61M 2005/14288 Infusion or injection simulation simulation of surgery in general A61B34/10; training for or simulation of use of injection or infusion devices G09B23/285
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 2205/8281 spring operated
• 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 5/2066 comprising means for injection of two or more media, e.g. by mixing
• 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 5/285 : with sealing means to be broken or opened
• CPC Class Codes: A61M 5/31533 : Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• 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: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

A method of delivering epinephrine includes placing a distal end surface of a medical injector into contact with a target location of a patient. The medical injector includes a housing, an energy storage member, and a medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis and having a weight of less than 15 kg. The medicament container is coupled to a needle. The medical injector is actuated such that the energy storage member produces a force to move the needle from a first needle position to a second needle position. A distal tip of the needle extends from the distal end surface by a distance of between 7 millimeters and 8 millimeters when the needle is in the second needle position. A portion of the force is exerted to expel the dose of epinephrine when the needle is in the second position.

Claims

1. A method, comprising:

placing a distal end surface of a medical injector into contact with a target location of a patient, the medical injector including a housing, an energy storage member and a medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis, the medicament container coupled to a needle via a carrier, the carrier including a retention portion and defining a coupling volume, the retention portion of the carrier configured to retain a distal end portion of the medicament container in a first container position within the coupling volume, the distal end portion of the medicament container fluidically isolated from a proximal tip of the needle when the medicament container is in the first container position, the distal end portion of the medicament container configured to move to a second container position within the coupling volume in response to an actuation force, the distal end portion of the medicament container fluidically coupled to the proximal tip of the needle when the medicament container is in the second container position, the retention portion including an annular protrusion defining a bleed passageway from the coupling volume towards a proximal end portion of the carrier; and

actuating the medical injector after the placing such that the energy storage member produces the actuation force to move the needle from a first needle position to a second needle position, a distal tip of the needle extending from the distal end surface by a distance of at least 6.35 millimeters when the needle is in the second needle position, the actuation force further moving the medicament container from the first container position to the second container position, a portion of the actuation force exerted to expel the dose of epinephrine from the medicament container when the needle is in the second position.

2. The method of claim 1, wherein the patient has a weight range of between 7.5 kg and 15 kg.

3. The method of claim 1, wherein the placing includes placing the distal end surface into direct contact with a clothing article covering the target location.

4. The method of claim 1, wherein:

the distal end surface is a distal end surface of an actuator; and

the actuating includes pressing the actuator against the target location such that the actuator moves relative to the housing to release an energy from the energy storage member.

5. The method of claim 1, wherein the distal tip of the needle extends from the distal end surface by a distance of between at least 6.35 millimeters and 8 millimeters when the needle is in the second needle position.

6. The method of claim 1, wherein the patient experiencing anaphylaxis has a weight of less than 15 kg.

7. The method of claim 1, wherein the dose of epinephrine includes about 0.1 ml of a solution containing about 0.1 mg epinephrine, about 0.78 mg sodium chloride, and about 0.15 mg sodium bisulfite hydrochloric acid.

8. The method of claim 4, wherein the actuating includes pressing the actuator against the target location with an actuator release force between about 8.9 N (2 lbf) and about 44.5 N (10 lbf).

9. The method of claim 8, wherein the force is about 26.7 N (6 lbf).

10. The method of claim 8, wherein:

the target location is a thigh; and

the actuation force is such that the distal tip of the needle is within a thigh muscle when the needle is in the second needle position to expel the dose of epinephrine intramuscularly into the thigh muscle.

11. The method of claim 10, further comprising:

before the actuating, pinching the thigh muscle.

12. The method of claim 10, further comprising:

restraining, with a first hand, a leg of the patient before the actuating, the actuating including pressing the actuator against the target location with a second hand such that the actuator moves relative to the housing to release an energy from the energy storage member.

13. An apparatus, comprising:

a housing;

a contact surface coupled to the housing, the contact surface configured to contact a target location of a patient;

a medicament container at least partially disposed within the housing, the medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis, the medicament container coupled to a needle;

a carrier including a retention portion and defining a coupling volume, the medicament container coupled to the needle via the carrier, the retention portion of the carrier configured to retain a distal end portion of the medicament container in a first container position within the coupling volume, the distal end portion of the medicament container fluidically isolated from a proximal tip of the needle when the medicament container is in the first container position, the distal end portion of the medicament container configured to move to a second container position within the coupling volume in response to an actuation force, the distal end portion of the medicament container fluidically coupled to the proximal tip of the needle when the medicament container is in the second container position, the retention portion including an annular protrusion defining a bleed passageway from the coupling volume towards a proximal end portion of the carrier;

an energy storage member within the housing, the energy storage member configured to produce the actuation force to move the needle from a first needle position to a second needle position and to move the medicament container from the first container position to the second container position, a distal tip of the needle extending from the contact surface by a distance of at least 6.35 millimeters when the needle is in the second needle position; and

an actuator configured to actuate the energy storage member to release the actuation force.

14. The apparatus of claim 13, wherein the dose of epinephrine contains between about 0.06 mg epinephrine and about 0.150 mg epinephrine.

15. The apparatus of claim 13, wherein the patient has a weight range of between 7.5 kg and 15 kg.

16. The apparatus of claim 13, wherein a distal tip of the needle extending from the contact surface by a distance of between about at least 6.35 millimeters and about 9 millimeters when the needle is in the second needle position.

17. The apparatus of claim 13, wherein the dose of epinephrine includes about 0.1 ml of a solution containing about 0.1 mg epinephrine, about 0.78 mg sodium chloride, and about 0.15 mg sodium bisulfite hydrochloric acid.

18. The apparatus of claim 13, wherein:

the contact surface and the actuator are monolithically constructed; and

the actuator is coupled to a distal end portion of the housing, the actuator configured to move relative to the housing to actuate the energy storage member.

19. The apparatus of claim 18, wherein the contact surface is planar.

20. The apparatus of claim 18, wherein the actuator includes a detent protrusion configured to matingly engage a detent recess of the distal end portion of the housing, the detent protrusion of the actuator and the detent recess of the housing configured such that the actuator moves relative to the housing when an actuator release force is applied to the contact surface.

21. The apparatus of claim 20, wherein the actuator release force is between about 8.9 N (2 lbf) and about 44.5 N (10 lbf).

22. An apparatus, comprising:

a housing;

a contact surface coupled to the housing, the contact surface configured to contact a target location of a patient;

a medicament container at least partially disposed within the housing, the medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis, the medicament container coupled to a needle;

an energy storage member within the housing, the energy storage member configured to produce an actuation force to move the needle from a first needle position to a second needle position, a distal tip of the needle extending from the contact surface by a distance of at least 6.35 millimeters when the needle is in the second needle position; and

an actuator configured to actuate the energy storage member to release the actuation force;

wherein;

the medicament container includes at least 0.3 ml of a solution containing about 0.3 mg epinephrine;

a portion of the actuation force is exerted to move a plunger within the medicament container by a plunger distance to expel the dose of epinephrine when the needle is in the second needle position; and

the medicament container is coupled to the needle via a carrier, a release member of the carrier configured to release the portion of the actuation force after the plunger has moved the plunger distance,

the carrier configured to retain a distal end portion of the medicament container within a coupling volume, a retention portion of the carrier configured to retain the distal end portion of the medicament container in a first container position within the coupling volume, the distal end portion of the medicament container fluidically isolated from a proximal tip of the needle when the medicament container is in the first container position, the distal end portion of the medicament container configured to move to a second container position within the coupling volume in response to the actuation force, the distal end portion of the medicament container fluidically coupled to the proximal tip of the needle when the medicament container is in the second container position, the retention portion including an annular protrusion defining a bleed passageway from the coupling volume towards a proximal end portion of the carrier.

23. The apparatus of claim 22, wherein:

the dose of epinephrine has a nominal value of 0.10 ml of the solution; and

the release member of the carrier is configured such that a delivered dose of epinephrine is between 0.085 ml and 0.115 ml.