Medical device

• US 6,740,062 B2
• Filed: 05/22/2001
• Issued: 05/25/2004
• Est. Priority Date: 05/22/2000
• Status: Expired due to Fees

• Current Assignee: Pharmacia AB (Pharmacia Corp.)
• Original Assignee: Pharmacia AB (Pharmacia Corp.)
• Inventors: Hjertman, Birger
• Primary Examiner(s): Esquivel, Denise L.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/862,563
• Publication Number:
  US 20020035348A1
• Time in Patent Office: 1,099 Days
• Field of Search: 604/187, 604/131, 604/191, 604/68, 604/70, 604/82, 604/133, 604/181, 604/90
• US Class Current: 604/187
• CPC Class Codes: A61M 2005/2462 by displacing occluding plugs
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 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

Abstract

The invention relates to an injector device for delivery of liquid from a high pressure source, and also to a method of performing such an injection. The device comprises a storage chamber 6, for the liquid or the liquid precursor components, comprising a storage barrel 16 with at least a section of substantially constant cross-section, defining a storage chamber axis, and a pressure chamber 4 comprising a pressure barrel 10 of substantially constant cross-section, defining a pressure chamber axis, for accommodation of at least one piston therein and having a front end opening 14 for ejection of the liquid. The pressure chamber being of sufficient strength to sustain the liquid pressure. The chambers are separate parts and adapted to cooperate with each other during injection so that the pressure chamber axis and the storage chamber axis substantially coincide, and that the pressure barrel and storage barrel have internal diameters sufficiently similar to allow passage of a resilient piston from the storage barrel to the pressure barrel in a sealing manner. The liquid is transferred from the storage chamber directly into the delivery chamber when the jet injection is to be performed.

Claims

1. An injector device for delivery of liquid from a high pressure source, the device comprising

a) a pressure chamber comprising a pressure barrel of substantially constant cross-section, defining a pressure chamber axis, adapted for accommodation of at least one piston therein and having a front end opening for ejection of liquid, the pressure chamber being of sufficient strength to sustain the pressure of liquid from a high pressure source and being empty or filled with gas;

b) a storage chamber, for liquid or liquid precursor components, comprising a storage barrel with at least a section of substantially constant cross-section, defining a storage chamber axis, adapted for accommodation of at least one piston therein, optionally with a by-pass section therein;

c) a liquid connection between the pressure chamber and the storage chamber adapted to allow transfer of liquid from the storage chamber to the pressure chamber;

d) at least a first piston arranged for travel in the pressure barrel; and

e) a mechanism adapted to apply force, directly or indirectly, on the piston when in the pressure barrel to create said liquid pressure;

wherein

i) the pressure chamber axis and the storage chamber axis substantially coincide;

ii) the pressure barrel and storage barrel have internal diameters sufficiently similar to allow passage of a resilient piston from the storage barrel to the pressure barrel in a sealing manner, except when in the optional by-pass or the connection, and

(iii) the storage chamber is separate from the pressure chamber.

2. Injector device according to claim 1, wherein the front end opening is adapted for formation of a liquid jet, with a short needle having a length of about 1 to 3 mm, or with a hypodermic needle.

3. Injector device according to claim 1, wherein the front end opening is covered with a removable or breakable closure or sealing.

4. Injector device according to claim 1, wherein said pressure barrel is provided with an open rear end and said storage barrel is provided with an open front end.

5. Injector device according to claim 1, wherein the liquid connection comprises a by-pass adapted to allow liquid passage from the storage chamber to the pressure chamber around the front piston.

6. Injector device according to claim 1, wherein the pressure chamber and storage chamber are made from different materials.

7. Injector device according to claim 1, wherein a sealer is provided between the pressure chamber and the storage chamber.

8. Injector device according to claim 1, further comprising a second piston adapted for movement in the storage chamber and to confine the storage chamber in cooperation with the first piston.

9. Injector device according to claim 1, wherein the pressure chamber is of sufficient strength to sustain a liquid pressure above 25 atm (2.5 MPa).

10. Injector device according to claim 1, wherein the pressure chamber has a larger volume than the liquid volume in the storage chamber, after optional mixing.

11. Injector device according to claim 1, wherein the liquid connection comprises a by-pass structure for the piston.

12. Injector device according to claim 1, wherein said mechanism is adapted to act on a rear piston.

13. Injector device according to claim 1, wherein said mechanism comprises a mechanical spring or pressurized gas.

14. Injector device according to claim 1, wherein said mechanism is also arranged for transfer of liquid.

15. Injector device according to claim 1, further comprising a hypodermic needle attached in connection with the front end opening to be able to perform a hypodermic injection.

16. An injector device for delivery of liquid from a high pressure source, the device comprising

a) a pressure chamber comprising a pressure barrel of substantially constant cross-section, defining a pressure chamber axis, adapted for accommodation of at least one piston therein and having a front end opening for ejection of liquid, the pressure chamber being of sufficient strength to sustain the pressure of liquid from a high pressure source;

b) a storage chamber, for liquid or liquid precursor components, comprising a storage barrel with at least a section of substantially constant cross-section, defining a storage chamber axis, adapted for accommodation of at least one piston therein, optionally with a by-pass section therein;

c) a liquid connection between the pressure chamber and the storage chamber adapted to allow transfer of liquid from the storage chamber to the pressure chamber;

d) at least a first piston arranged for travel in the pressure barrel; and

e) a mechanism adapted to apply force, directly or indirectly, on the piston when in the pressure barrel to create said liquid pressure;

wherein

i) the pressure chamber axis and the storage chamber axis substantially coincide;

ii) the pressure barrel and storage barrel have internal diameters sufficiently similar to allow passage of a resilient piston from the storage barrel to the pressure barrel in a sealing manner, except when in the optional by-pass or the connection, and

(iii) the storage chamber is separate from the pressure chamber;

wherein said storage chamber is a dual chamber storage chamber provided with by-pass section wherein the injector device further comprises at least a third piston dividing the storage chamber into two subchambers, and wherein the pressure chamber is adapted to have a sufficient volume for accommodation of substantially all liquid transferred from the storage chamber.

17. An injector device for delivery of liquid from a high pressure source, the device comprising

a) a pressure chamber comprising a pressure barrel of substantially constant cross-section, defining a pressure chamber axis, adapted for accommodation of at least one piston therein and having a front end opening for ejection of liquid, the pressure chamber being of sufficient strength to sustain the pressure of liquid from a high pressure source and being empty or filled with gas;

b) a storage chamber, for liquid or liquid precursor components, comprising a storage barrel with at least a section of substantially constant cross-section, defining a storage chamber axis adapted for accommodation of at least one piston therein, optionally with a by-pass section therein;

c) a liquid connection between the pressure chamber and the storage chamber adapted to allow transfer of liquid from the storage chamber to the pressure chamber;

d) at least a front piston and a rear piston arranged for travel in the pressure barrel and storage barrel; and

e) a mechanism arranged to apply force, directly or indirectly, on the piston when in the pressure barrel to create said liquid pressure;

wherein

i) the pressure chamber axis and the storage chamber axis substantially coincide to form a chamber aggregate,

ii) the mechanism comprises a plunger arranged axially movable in at least the forward direction with respect to a device part, forming a reference point for the movement,

(iii) the chamber aggregate is connected to be axially movable in at least the rearward direction with respect to the reference point, and

(iv) the relative positions of the plunger and the chamber aggregate with respect to the reference points allow the chamber aggregate to perform the rearward movement with the plunger and rear piston in contact while the plunger is kept stationary and allow the plunger to perform the forward movement in contact with the rear plunger while the chamber aggregate is kept stationary.

18. Injector device according to claim 17, wherein the relative positions are arranged to allow, during the chamber aggregate rearward movement, at least the transfer of liquid from the storage chamber to the pressure chamber, and optionally a de-aeration of the pressure chamber, and allow, during the plunger forward movement, ejection of liquid from the pressure chamber.

19. Injector device according to claim 17, wherein the rearward movement of the chamber aggregate is adapted for manual actuation.

20. Injector device according to claim 19, wherein the forward movement of the plunger is adapted for triggered release of stored energy.

21. Injector device according to claim 17, wherein the pressure chamber is of sufficient strength to sustain a liquid pressure above 25 atm (2.5 MPa).

22. Injector device according to claim 17, further comprising a hypodermic needle attached in connection with the front end opening to be able to perform a hypodermic injection.

23. A pressure chamber and storage chamber combination to be used for jet injection of a liquid medicine, comprising

a) a pressure chamber having a pressure barrel, having at least a section of substantially constant cross-section, defining a pressure chamber axis, for accommodation of at least one piston therein, and having a front end opening for ejection of liquid, the pressure chamber being of sufficient strength to sustain the pressure of liquid from a high pressure source and being empty or filled with gas, and

(b) a storage chamber, comprising a storage barrel with at least a section of substantially constant cross-section, defining a storage chamber axis, at least one front sealer or piston and at least one rear sealer or piston, the pistons being inserted in the barrel and enclosing a liquid or liquid precursor components, wherein said pressure chamber and storage chamber are made of different materials and are adapted to be inter-connected with the pressure chamber axis and the storage chamber axis in substantially co-axial relationship, the pressure barrel and storage barrel having substantially similar internal diameters.

24. The pressure chamber and storage chamber combination according to claim 23, wherein the pressure chamber is made from plastic.

25. The pressure chamber and storage chamber combination according to claim 23 provided with a liquid connection between the pressure chamber and the storage chamber adapted to allow transfer of the liquid from the storage chamber to the pressure chamber.

26. The pressure chamber and storage chamber combination according to claim 25 wherein the liquid connection comprises a by-pass arrangement on the pressure barrel adapted to allow passage of liquid around the piston.

27. The pressure chamber and storage chamber combination according to claim 23, further comprising an area to the rear of the liquid connection adapted for a seal between the pressure chamber and the storage chamber.

28. Pressure chamber according to claim 23, further comprising a hypodermic needle attached in connection with the front end opening to be able to perform a hypodermic injection.

29. The pressure chamber and storage chamber combination according to claim 23, wherein the pressure chamber is of sufficient strength to sustain a liquid pressure above 25 atm (2.5 MPa).

30. Method of performing an injection of a liquid medicine, the method comprising the following steps:

i) assembling a medicine storage chamber, defining a storage chamber axis and containing liquid medicine, and a pressure chamber being empty or filled with gas and defining a pressure chamber axis, to form a chamber assembly so that said axes coincide;

ii) arranging the chamber assembly in relation with an injection device having a pressurizing mechanism arranged to generate a force;

iii) transferring the liquid medicine into the pressure chamber by relative movement between the chamber assembly and said pressurizing mechanism; and

iv) applying a sufficient force from said pressurizing mechanism on the pressure chamber to perform the injection.

31. The method of claim 30, wherein the relative movement between the chamber assembly and the pressurizing mechanism is performed while the pressurizing mechanism is idle.

32. The method of claim 31, wherein step iv) is performed by activation of the pressurizing mechanism while the chamber assembly is kept stationary with respect to the pressurizing mechanism.

33. The method of claim 30, wherein the pressure chamber is of sufficient strength to sustain a liquid pressure above 25 atm (2.5 MPa).

34. Method of performing an injection by injector device for delivery of liquid from a high pressure source, the method comprising the steps of:

a) maintaining an initial content of gas only in a pressure chamber;

b) confining liquid, or liquid precursor components, in a storage chamber;

c) transferring the liquid from the storage chamber to the pressure chamber initially containing gas, the pressure chamber having an opening for ejection of the liquid and being of sufficient strength to sustain the liquid pressure, the transfer of the liquid from the storage chamber to the pressure chamber displacing gas contained therein through the front end opening; and

d) pressurizing the pressure chamber to create the liquid pressure for delivery of liquid through the opening while keeping the storage chamber stationary with respect to the pressure chamber.

35. Method according to claim 34, wherein the pressure chamber is initially substantially gas filled.

36. Method according to claim 34, wherein, before step a), components in the storage chamber are mixed to create the liquid.

37. Method according to claim 34, wherein the force in step d) is higher than in step c).

38. Method according to claim 34, wherein the pressure chamber comprises a pressure barrel of substantially constant cross-section for accommodation of at least one piston therein and wherein the transferring step comprises the step of passing the liquid past the piston.

39. Method according to claim 38, wherein the storage chamber comprises a storage barrel of substantially constant cross-section adapted for accommodation of at least one piston therein, and wherein the passing step comprises the step of moving the liquid by moving a second piston inserted in the storage barrel forwards.

40. Method according to claim 39, wherein the pressurizing step includes the step of moving the piston and the second piston together forwards in the pressure barrel.

41. The method of claim 34, wherein the pressure chamber is of sufficient strength to sustain a liquid pressure above 25 atm (2.5 MPa).