Injection device for administering a vaccine

• US 7,896,841 B2
• Filed: 02/17/2005
• Issued: 03/01/2011
• Est. Priority Date: 02/17/2004
• Status: Active Grant

• Current Assignee: Children's Hospital & Medical Center
• Original Assignee: Children's Hospital & Medical Center
• Inventors: Ward, Jarvis, Wall, Eric James, Nesbitt, Daniel Frederick, Nesbitt, Christopher J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Price; Nathan R
• Application Number:
  US10/597,997
• Publication Number:
  US 20070276320A1
• Time in Patent Office: 2,203 Days
• Field of Search: 604/117, 604131-139, 604/156, 604/157, 604192-198, 604/239
• US Class Current: 604/135
• CPC Class Codes: A61M 2005/3106 Plugs for syringes without needle
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3139 Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
• CPC Class Codes: A61M 2005/325 Means obstructing the needle passage at distal end of a needle protection sleeve
• CPC Class Codes: A61M 2205/583 by visual feedback
• 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 5/24 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 5/2429 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61M 5/347 rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/484 Regulating injection pressure
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

An injection device that self-administers a painless vaccine injections. The injection device (10) can be secured to the patient'"'"'s skin via a separable base portion (12) of the housing of the device, which can be separated from the device when removing the housing and syringe assemblies for disposal. The injection device can provide a method for substantial amount of time performing the injection procedure, that is relatively simple and inexpensive to perform and operate, and that provides a relatively high degree of safety for both the medical personnel and for the patient. The injection device is configured for easy handling, and is manually-powered by the use of the hand or fingers of the medical technician. The device can also comprise a plurality of vaccine syringes at the same time with a single device.

Claims

1. An injection device for self-administering vaccine injections to a patient, comprising:

a housing having a base portion;

a needle positioned within the housing, the needle having an injection end and having an outside diameter greater than 0.20 mm and less than about 0.38 mm that effects a painless insertion of the needle into the patient, the needle moveable between a first position having its injection end wholly within the housing, and a second position wherein the injection end extends through and beyond the base portion;

a reservoir for the vaccine, in liquid communication with the needle; and

a means for injecting a vaccine from the reservoir through the needle;

a separable base associated with the base portion having a skin-facing surface and an opposed surface, the separable base comprising an adhesive on the skin-facing surface that secures the device to the skin of a patient during the time that the device self-administers the injection of the vaccine to the patient, and

a means for separably securing the separable base with the base portion, and a base separating means for selectively separating the separable base from the device while the separable base is secured to the skin.

2. The device according to claim 1 wherein the separable base can be re-affixed to the base portion after separation.

3. The device according to claim 1 wherein the separable base comprises an adhesive flap extending from a periphery of the separable base, the flap having an adhesive on a skin-facing surface thereof.

4. The device according to claim 3 wherein the adhesive flap extends from the entire periphery of the separable base.

5. The device according to claim 1 wherein the means for separably securing the separable base to the base portion can comprise:

a mechanical securement, an adhesive securement, and a magnetic securement, of the separable base with the housing.

6. The device according to claim 1 wherein the means for separably securing comprises at least one engagement in the opposed surface of the separable base;

and at least one engaging member extending from the base portion of the housing;

wherein the at least one engaging member has a first position associated with the engagement wherein the removable base is secured to the housing, and a second position associated with the engagement wherein the removable base is not secured to the housing.

7. The device according to claim 6 wherein the removable base has a slot in the opposed surface, wherein the at least one engaging member has a latch whereby the latch engages the slot in its first position, thereby securing the seperable base to the housing, and wherein the at least one engaging member can be biased to the second position wherein the latch is not engaged with the slot, thereby unsecuring the separable base to the housing.

8. The device according to claim 7 wherein the at least one engaging member has a button affixed thereto configured to accept a biasing force from outside the housing, which biases the latch of the engaging member to its second, unsecured position.

9. The device according to claim 6, further comprising a means for retracting the needle which retracts the injection end of the needle from its extended position to a position within the housing.

10. The device according to claim 9 wherein the needle retracting means comprises a needle insertion securement having a first position that secures the needle in its extended position, and a second position that does not secure the needle in its extended position, and a power means for biasing the needle toward a position within the housing, whereby when the needle is not secured in its extended position, the needle is retracted to its housing position, and the injection end of the needle is positioned within the housing.

11. The device according to claim 10 wherein the at least one engaging member can not be biased to its second position unless the needle is at its housing position, thereby preventing the injection end of the needle from being extended beyond the base portion of the housing when the separable base is removed from the housing.

12. The device according to claim 1 wherein the self-administering device holds itself in a position attached to the skin of the patient, without requiring a medical technician, the patient, or other person, to hold the device, during the time that the vaccine is injected into the patient through the needle, and wherein the adhesive on the skin-facing surface of the separable base provides adhesive, hands-free, self-attachment of the device to the skin of the patient.

13. The device according to claim 1, wherein the injecting means injects the vaccine at a substantially constant volumetric flow rate of about 0.5 μ

L/s to about 20 μ

L/s from the reservoir through the needle, which effects a painless injection.

14. The device according to claim 1, further comprising a means for retracting the needle which retracts the injection end of the needle from its extended position to a position within the housing.

15. The device according to claim 14 further comprising at least one engaging member that can be biased to a second position wherein the removable base is not secured to the housing, wherein the at least one engaging member cannot be biased to its second position unless the needle is at its housing position, which prevents the injection end of the needle from extending beyond the base portion of the housing when the separable base is removed from the housing.

16. An injection device for self-administering vaccine injections to a patient, comprising:

a housing having a base portion;

a needle positioned within the housing, the needle having an injection end having an outside diameter greater than 0.20 mm and less than about 0.38 mm, and being configured for extension to a position wherein the injection end extends through and beyond the base portion;

a reservoir for the vaccine in liquid communication with the needle; and

a means for injecting a vaccine from the reservoir through the needle;

a separable base associated with the base portion having a skin-facing surface and an opposed surface, the separable base comprising an adhesive on the skin-facing surface that secures the device to the skin of a patient during the time that the device self-administers the injection of the vaccine to the patient,

a means for separably securing the separable base with the base portion, and

a means for retracting the needle, which retracts the injection end of the needle from its extended position to a position within the housing.

17. The device according to claim 16 wherein the needle retracting means separates of the separable base from the separable base portion of the housing after the needle is retracted to its housing position.

18. The device according to claim 16 further comprising a base separating means for selectively separating the separable base from the device while the separable base is secured to the skin.