Hypodermic injection system

• US 6,258,063 B1
• Filed: 09/24/1999
• Issued: 07/10/2001
• Est. Priority Date: 01/17/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Meacham, George Bevan, Beuttenmüller, Manfred, Haar, Hans-Peter, Mattern, Markus
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/341,766
• Time in Patent Office: 655 Days
• Field of Search: 604/140, 604/118, 604/121, 604/122, 604/125, 604/131, 604/132, 604/141, 604/142, 604/145, 604/187, 604/181, 604/185, 604/212, 604/217, 604/204, 604/200, 604/244, 604/68, 604/69, 604/70, 604/72, 222/92, 222/93, 222/95, 222/633, 222/380, 222/207, 222/214, 222/389, 222/397, 222/399
• US Class Current: 604/141
• 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 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 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• 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 5/3145 Filters incorporated in syringes
• CPC Class Codes: A61M 5/484 Regulating injection pressure

Abstract

A hypodermic injection system allows for the generation of a high pressure liquid jet capable of passing through the skin. The system uses two regions, the first region being flexible or squeezable and the second region having at least one exiting orifice through which the liquid jet can be expelled. The flexible region can be deformed by a pressure change in the surrounding container generated by an activatable gas generator that generates pressure within the first region that causes the liquid to be expelled.

Claims

1. A hypodermic injection system for injecting liquids, which comprises:

(a) a medication unit configured and dimensioned to store a volume of liquid to be injected, the medication unit having first region and a second region that are in liquid communication with each other, the first region being deformable and the second region having at least one orifice;

(b) an explosion chamber configured and dimensioned so that the medication unit is located at least partially within the explosion chamber and so that pressure generated within the explosion chamber would cause the first region of the medication unit to deform so as to reduce the volume within the medication unit, the explosion chamber further having a gas port for exhausting gas from the explosion chamber;

(c) an activatable gas generator located inside the explosion chamber, the gas generator being capable of generating a pressure within the explosion chamber when activated;

(d) an activation unit for activating the gas generator; and

(e) a free volume chamber having a variable volume, the free volume chamber being in fluid communication with the explosion chamber via the gas port.

2. The hypodermic injection system according to claim 1, wherein the free volume chamber is formed by a housing in which a piston is movably located, the position of the piston within the housing determining the volume of the free volume chamber.

3. The hypodermic injection system according to claim 1, therein the gas port has a cross-section in the range of 2 mm to 5 mm.

4. The hypodermic injection system according to claim 1, wherein the volume of the free volume chamber can be varied between a volume of zero and a volume of four times the volume of the explosion chamber.

5. The hypodermic injection system according to claim 1, wherein the free volume chamber has a vent.

6. The hypodermic injection system according to claim 5, wherein the vent has a cross-section of 0.01 mm to 0.5 mm.

7. The hypodermic injection system according to claim 1 further comprising a filter located between the explosion chamber and the free volume chamber, the filter being configured and dimensioned so as to filter gas exiting the explosion chamber and entering the free volume chamber.

8. The hypodermic injection system according to claim 7, wherein the filter has a plurality of holes, each with a diameter in the range of 0.5 mm to 1 mm.

9. The hypodermic injection system according to claim 8, wherein the total area of all the holes in the filter provides a flow area equivalent to a single hole having a diameter in the range of 2 mm to 8 mm.

10. The hypodermic injection system according to claim 1, wherein the free volume chamber is partitioned into a first free volume portion and a second free volume portion, the first free volume portion and the second free volume portion being connected by a channel.

11. The hypodermic injection system according to claim 10, wherein at least one of the first free volume portion and the second free volume portion has an adjustable volume.

12. The hypodermic injection system according to claim 11, wherein the first free volume portion is adjustable by a user and the second free volume portion is adjusted by the manufacturer.

13. The hypodermic injection system according to claim 1, wherein the free volume chamber is formed by a housing and a tapered piston that moves within the housing, the housing being configured and dimensioned to correspondingly conform to the piston when the volume of the free volume chamber is minimal.

14. The hypodermic injection system according to claim 13, wherein the housing of the free volume chamber has a first free volume portion, a second free volume portion, and a channel which connects the first free volume portion with the second free volume portion.

15. The hypodermic injection system according to claim 14, wherein the tapered piston has a tapered portion and a cylindrical portion, the channel being configured and dimensioned within the housing so that the channel is closed when the first free volume portion has a minimal volume and opened when the volume of the first free volume portion is increased.

16. A handling unit for use in a hypodermic injection system, which comprises:

(a) a first shell having an explosion chamber and an explosive therein;

(b) a second shell having a piercing needle disposed therein, the piercing needle having a piercing end;

(c) a medication unit having a concave portion, the medication unit being sandwiched between the first shell and the second shell, the concave portion being arranged adjacent to the piercing end of the needle so that when pressure is applied to the medication unit by an explosion in the first shell, the medication unit generates a flexing deformation of its concave portion that leads to the piercing needle piercing the medication unit.

17. The handling unit according to claim 16, wherein the medication unit comprises a convex portion opposite to the concave portion which prevents piercing of the convex portion when the medication unit is deformed under pressure.

18. The handling unit according to claim 16, wherein the second shell has a recess to receive the medication unit therein and to support the portion of the medication unit that is adjacent to the second shell while allowing deformation of the concave portion.

19. The handling unit according to claim 16, wherein a space is formed between the concave portion of the medication unit and the second shell, and the handling unit has a vent that allows gas to escape from the space when this concave portion is moved towards the second shell.

20. Handling unit for hypodermic injections comprising

a first shell providing an explosion chamber and an explosive therein,

a second shell with a piercing needle disposed therein

a medication unit having a concave portion and being sandwiched between first and second shell

wherein the concave portion is being arranged beneath a pointed end of said needle and pressure applied to the medication unit generates a flexing deformation of the concave portion thus leading to a piercing of the medication unit.

21. Handling unit according to claim 20, wherein the medication unit comprises a convex portion in its first segment which prevents piercing of the first segment when the medication unit is deformed under pressure.

22. Handling unit according to claim 20, wherein the second shell has a recess to receive a medication unit therein and supporting said second segment to prevent deformation of the second segment with exception of the concave portion.

23. Handling unit according to claim 20 with a space (32) generated by the concave portion of the medication unit and the second shell (27), wherein said handling unit comprises a vent (31) which allows gas to escape from said space when the concave portion is moved in direction towards the second shell.

24. Hypodermic injection system comprising

a medication unit (51) in which liquid to be injected is stored and which has a first and a second region, said first region being squeezable or flexible and said second region having at least one orifice,

an explosion chamber (92) in which the medication unit is located at least partially and a pressure generated within said explosion chamber is deforming said first region of the medication unit,

an activatable gas generator (93) located inside the explosion chamber (92) which generates a pressure within the explosion chamber when activated, wherein said explosion chamber has a vent which allows gas escaping the explosion chamber in a controlled way.

25. Hypodermic injection system according to claim 24, wherein the flow resistance of the system for combustion gases is adapted to provide a desired pressure over time curve which leads to proper injections.

26. A medication unit for use in a hypodermic injection system, which comprises:

(a) a first region which is deformable and configured and dimensioned to store a liquid to be injected;

(b) a second region having at least one orifice, the second region being in liquid communication with the first region, the first region and the second region being separate pieces that are enveloped within a common wall;

(c) liquid medication contained within the first region, the second region, or both the first region and the second region; and

(d) a closure for closing the at least one orifice.

27. The medication unit of claim 26, wherein the medication unit is made from polyvinyl chloride, polyethylene, polypropylene, or mixtures thereof.

28. The medication unit according to claim 26, wherein the closure is connected to the second region via a connection having a predetermined breaking point.

29. A medication unit for use in a transdermal injection system, which comprises:

(a) a first region which is deformable and formed by a wall;

(b) a second region which is formed from a piece of material separate from that of the first region, the second region having at least one orifice and being in liquid communication with the first region, the first region and the second region being enveloped within in the wall of the first region;

(c) liquid medication contained within the first region and the second region; and

(d) a closure for closing the at least one orifice.

30. The medication unit according to claim 29, wherein the wall is integrally connected to a tab via a predetermined breaking region.

31. The medication unit according to claim 29, wherein the first region has a substantially planar bottom and a tapered wall portion connected to the bottom via a widening wall portion.

32. The medication unit according to claim 29, wherein the second region comprises a nozzle of rotational symmetry and exponential slope.

33. The medication unit according to claim 32, wherein the second region is made from a soft plastic and at least a part of the nozzle is surrounded on the outside by a ring made from a hard material.

34. A medication unit for use in a hypodermic injection system, which comprises a first segment and a second segment, each configured and dimensioned to be fixed to one another to form a cavity for a liquid medication, the second segment configured to have a concave portion that flexes outwardly when pressure is applied to the first segment, the first segment and the second segment being welded together and the medication unit having a thickened portion annularly surrounding the cavity at the point where the first segment and the second segment are welded together.

35. The medication unit according to claim 34, wherein the first segment has a convex portion.