Needleless hypodermic injection system, application device and medication cartridge therefor

• US 6,986,754 B2
• Filed: 03/19/2002
• Issued: 01/17/2006
• Est. Priority Date: 03/22/2001
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Haar, Hans-Peter, Meacham, George Bevan Kirby, List, Hans, Engelhardt, Horst, Bruntrup, Otto, Thös, Bruno Robert, Gliewe, Christian, Bandau, Dirk, Riemensperger, Ulrich Josef, Ihle, Guenter Franz, Popp, Konrad Joseph
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/101,400
• Publication Number:
  US 20020169412A1
• Time in Patent Office: 1,400 Days
• Field of Search: 604 68- 72, 604/131, 604/140, 604/143
• US Class Current: 604/70
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/3118 via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
• CPC Class Codes: A61M 2005/312 comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A needleless hypodermic injection system for injecting a liquid medication, which system comprises a disposable cartridge which contains a medication and which includes a propellant and an igniter, and a reusable application device which comprises a pressure chamber for receiving the medication cartridge, actuation means including an ignition system and means for ensuring reliability and safety of the system. The reusable application device comprises:

• (a) a housing including a fist housing section and a second housing section which are adapted to be assembled together by a screwing operation, the first housing section comprising a front part having an injection outlet and a chamber adapted to receive a the cartridge contains the medication to be injected and also contains a propellant and an igniter, and
• (b) means for selectively activating said igniter of said cartridge when predetermined conditions are fulfilled.

Claims

1. A reusable application device for a needleless hypodermic injection system for injecting a liquid medication, which application device comprises:

(a) a housing including a first housing section and a second housing section which are adapted to be assembled together by a screwing operation,

said first housing section comprising a front part having an injection outlet and a chamber adapted to receive a cartridge containing a medication unit which contains the medication to be injected, a propellant, and an igniter,

(b) means for selectively activating said igniter of said cartridge when predetermined conditions are fulfilled, and

(c) means providing a visual or audible indication to the user when said predetermined conditions are met and the device is ready for performing an injection.

2. A reusable application device for a needleless hypodermic injection system for injecting a liquid medication contained in a cartridge inserted into said application device, said application device comprising:

a) a housing including a first section and a second section which are adapted to be connected with each other to form a housing assembly,

said first housing section comprising a chamber for receiving a cartridge containing a medication unit which contains a liquid medication,

said first housing section having a symmetry axis which extends along its length and a front part having an outer contact surface which is adapted to be applied on a skin surface, said contact surface having an opening through which liquid medication ejected from said cartridge can pats and be injected through said skin surface,

b) ejection means for causing ejection of said liquid medication contained in said cartridge in order to perform an injection, a first part of said ejection means being contained in said cartridge and a second part of said ejection means being contained in said second housing section,

c) assembly detecting means which reach a first predetermined state when said first housing section is properly and completely assembled with said second housing section to form said housing assembly, said assembly detecting means being located within said housing assembly,

d) position detecting means which are located in part within said first housing section and in part in said second housing section, said position detecting means reaching a second predetermined state when the following conditions are simultaneously satisfied by the relative position of said housing assembly with respect to said skin surface,

d.2) said contact surface of said first section exerts a predetermined pressure on said skin surface, the distribution of said pressure over the area of said contact surface being substantially uniform, and

d.3) said symmetry axis of said first section is positioned substantially normal to said skin surface, and

e) actuator means for activating said election means, said actuator means being normally disabled and becoming operable only upon being enabled by a combination of predetermined effects provided by

said assembly detecting means after they reach said first predetermined state, and said position detecting means when they reach said second predetermined state.

3. A device according to claim 2, wherein said second housing section comprises means which are adapted to cooperate with a corresponding part of said first housing section for clamping with a predetermined preload and for hermetically closing a cartridge inserted into said cartridge receiving chamber.

4. A device according to claim 2, wherein said assembly detecting means exclusively comprise mechanical means.

5. A device according to claim 2, wherein said position detecting means exclusively comprise mechanical and electro-mechanical means, but no electronic means sensitive to electrical noise or other perturbating electrical signals.

6. A device according to claim 2, wherein said position detecting means comprise a first switch adapted to be mechanically actuated by a movable part of said position detecting means to establish an electrical connection when said position detecting means senses application of said front part of said first housing part on said skin surface with a predetermined pressure applied on the skin surface.

7. A device according to claim 2, wherein said first housing part and said second housing part are so shaped, dimensioned and configured that proper and complete assembly thereof is accurately defined and recognizable by visual and tactile inspection.

8. A device according to claim 2, wherein said first housing part and said second housing part are adapted to be assembled together by assembling steps which include a screwing operation.

9. A reusable application device according to claim 2, wherein said housing assembly is so configured and dimensioned that it is adapted to be held and used by a user with only one hand.

10. A reusable application device according to claim 2, which further comprises means providing a visual or audible indication to the user when said actuator device is enabled by said combination of predetermined effects.

11. A reusable application device for a needleless hypodermic injection system for injecting a liquid medication contained in a cartridge inserted into said application device, said cartridge containing a propellant adapted to be ignited by application of electrical energy to two electrical contacts which are part of said cartridge, said application device comprising:

a) a housing including a first section and a second section, each of these sections having a length axis and said first and second housing sections being adapted to be connected with each other to form a housing assembly, said housing assembly being so configured and dimensioned that it is adapted to be held by a user with one hand,

b) said first housing section comprising a chamber for receiving a cartridge containing a liquid medication, said first section having an outer contact surface which is adapted to be applied on a skin surface through which an injection is to be applied,

c) said second housing section containing electrical means for causing ignition of a propellant contained in a cartridge arranged in said chamber of said first housing section and actuator means for activating said electrical means, and

d) position detecting means for detecting whether said contact surface of said first section exerts a predetermined pressure on said skin surface and whether at the same time said length axis of said first section is positioned substantially normal to said skin surface, the distribution of said pressure over the area of said contact surface being substantially uniform, said means for detecting enabling said actuator means when the latter conditions are satisfied.

12. A device according to claim 11, wherein said second housing section comprises means which are adapted to cooperate with a corresponding part of said first housing section for clamping with a predetermined preload and for hermetically closing a cartridge inserted into said cartridge receiving chamber.

13. A reusable application device for a needleless hypodermic injection system for injecting a liquid medication, which application device comprises:

(a) a housing including a first housing section and a second housing section which are adapted to be assembled together by a screwing operation,

said first housing section comprising a front part having an injection outlet and a chamber adapted to receive a cartridge containing a medication unit which contains the medication to be injected, a propellant, and an igniter, and

(b) means for selectively activating said igniter of said cartridge when predetermined conditions are fulfilled,

wherein said means for selectively activating said igniter comprise a purely mechanical object sensor, and a first switch adapted to be mechanically actuated by a movable part of said object sensor to establish an electrical connection when said object sensor senses application of said front part of said first housing part on a body part.

14. A reusable application device for a needleless hypodermic injection system for injecting a liquid medication, which application device comprises:

(a) a housing including a first housing section and a second housing section which are adapted to be assembled together by a screwing operation,

said first housing section comprising a front part having an injection outlet and a chamber adapted to receive a cartridge containing a medication unit which contains the medication to be injected, a propellant, and an igniter, and

(b) means for selectively activating said igniter of said cartridge when predetermined conditions are fulfilled,

wherein at least part of said means for selectively activating said igniter are lodged within said second housing part and comprise an electrical circuit including

a battery,

said first switch

a second switch adapted to be actuated by a user,

interconnection conductors, and

two electrical terminals which correspond to respective terminals of said igniter, said electrical circuit being so configured that electrical current can flow from the battery to the igniter only when the following conditions are met;

i) said cartridge is properly positioned within said chamber of said first housing part,

ii) said first and said second housing part are completely and properly assembled, whereby said two terminals of said electrical circuit contact said respective terminals of said igniter,

iii) said first switch is actuated by said object sensor and thereby establishes an electrical connection, and

iv) said second switch is actuated by a user.

15. A medication cartridge for a needleless hypodermic injection system for injecting a liquid medication, said cartridge comprising a housing adapted to contain:

(a) a first chamber containing a medication unit configured and dimensioned to store a volume of liquid to be injected, said medication unit having a first region and a second region that are in liquid communication with each other, said first region being deformable and said second region having an injection outlet, and

(b) a second chamber containing a propellant,

said first chamber being divided by an elastic baffier in two zones, a first zone containing said medication unit and a second zone which is communication with said second chamber, so that upon ignition of the propellant in the second chamber gas generated thereby expands into said second zone of said first chamber, exerts pressure on and deforms said baffier which in turn transfers that pressure to and deforms said deformable first region of said medication unit and thereby causes ejection of said medication through said injection outlet, and

(c) means for mechanically setting the volume available within said cartridge for gas said expansion, so that said volume has a selected predetermined size.

16. A medication cartridge according to claim 15, which further comprises an envelope which surrounds said elastic barrier and protects it from direct contact with hot gas generated by ignition of said propellant in said second chamber.

17. A medication cartridge according to claim 16, wherein said envelope also forms a gas seal between said housing and said medication unit containing said liquid medication.