Safety mechanism to prevent accidental patient injection and methods of same

• US 7,887,506 B1
• Filed: 11/21/2000
• Issued: 02/15/2011
• Est. Priority Date: 11/23/1999
• Status: Expired due to Fees

• Current Assignee: Felton International Incorporated, Pulse Needlefree Systems, Inc.
• Original Assignee: Pulse Needlefree Systems, Inc.
• Inventors: Katov, Victor N., Leon, Nathaniel, Smolyarov, Boris V., Rogatchev, Victor T.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US09/717,559
• Time in Patent Office: 3,738 Days
• Field of Search: 604 68- 72, 604/140, 604/141, 604/143, 604/148, 604/232, 604/131
• US Class Current: 604/68
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling
• 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 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence

Abstract

Disclosed is a medical injection assembly in which the assembly is adapted to reduce the risk of accidental injection of a patient and prevent cross contamination of patients or injectors.

Claims

1. A multi-use, needle-free injector assembly having a proximal end and a distal end, the distal end having a distal end orifice, an injection piston located generally within an injector lumen, comprising:

(a) a removable cap generally distal to the distal end orifice, wherein the distal end orifice is distal to the injector lumen, the cap further including a cap distal face and cap proximal face;

(b) an injection prevention component disposed generally proximal to the cap distal face and distal to the distal end orifice;

(c) wherein the injection prevention component has a first injection prevention configuration to prevent the injector assembly from administering injectate to a subject at a sufficient pressure to pierce the skin and a second injection permitting configuration to permit the injector assembly to administer injectate to a subject, and

(d) wherein the injection prevention component is reversibly movable between the first injection prevention configuration when the cap is removed and the second injection permitting configuration when the cap is in place.

2. The injector assembly of claim 1, wherein the cap further includes a cap orifice extending therethrough, the cap orifice also being coincident with the injector lumen.

3. The injector assembly of claim 2, wherein the cap further includes a film disposed over the cap orifice.

4. The injector assembly of claim 3, wherein the film comprises at least one of a plastic, rubber, polymer, polyethylene, polytetrafloroethylene, polyurethane, polyolefin, polypropylene, and polysulfone material;

or combination thereof.

5. The injector assembly of claim 2, wherein the latch is adapted to disengageably engage with a proximal end of the injection piston.

6. The injector assembly of claim 5, wherein a rod is disposed between the cap proximal face and the injector lumen proximal end.

7. The injector assembly of claim 5, wherein the cap protective film comprises at least one of a plastic, rubber, polymer, polyethylene, polytetrafloroethylene, polyurethane, polyolefin, polypropylene, and polysulfone material;

or combination thereof.

8. The injector assembly of claim 2, wherein the injection prevention component further includes at least one of an orifice shield, a piston, and a latch.

9. The injector assembly of claim 8, wherein the cap further includes a film disposed over the cap orifice.

10. The injector assembly of claim 9, wherein the film comprises at least one of a plastic, rubber, polymer, polyethylene, polytetrafloroethylene, polyurethane, polyolefin, polypropylene, and polysulfone material;

or combination thereof.

11. The injector assembly of claim 9, wherein the orifice shield is disposed generally distal to the distal end orifice.

12. The injector assembly of claim 9, wherein the orifice shield is disposed generally proximal to the cap proximal face.

13. The injector assembly of claim 9, wherein the orifice shield includes a generally flat surface adapted to partially or completely block an injection stream distal of the distal end orifice to prevent the injector assembly from administering injectate to a subject at a sufficient pressure to pierce the skin.

14. The injector assembly of claim 9, wherein the orifice shield includes a generally flat surface adapted to block an injection stream distal of the distal end orifice to prevent the injector assembly from administering injectate to a subject at a sufficient pressure to pierce the skin.

15. The injector assembly of claim 9, wherein the orifice shield comprises a leaf spring.

16. The injector assembly of claim 9, wherein the orifice shield is detachably attached to a first side of the injector assembly.

17. The injector assembly of claim 9, wherein the orifice shield is adapted to cover the distal end orifice when the cap proximal face partially contacts the orifice shield.

20. The injector assembly of claim 9, wherein the piston further includes a lock pin.

21. The injector assembly of claim 20, wherein the lock pin protrudes into the injector lumen.

22. The injector assembly of claim 20, wherein the lock pin is adapted to interfere with the injection piston.

23. The injector assembly of claim 20, wherein the injection piston further comprises an injection piston recess adapted to detachably attach with the lock pin.

24. The injector assembly of claim 20, wherein the piston further comprises a rod disposed between the cap proximal face and the lock pin.

25. The injector assembly of claim 24, wherein the prevention component further comprises an orifice shield disposed distal to the distal end orifice.

26. The injector assembly of claim 24, wherein the film comprises at least one of a plastic, rubber, polymer, polyethylene, polytetrafloroethylene, polyurethane, polyolefin, polypropylene, and polysulfone material;

or combination thereof.

27. The injector assembly of claim 9, wherein the latch is disposed at a proximal end of the injector lumen.

18. The injector assembly of 17, wherein the orifice shield comprises a leaf spring.

19. The injector assembly of claim 18, wherein the orifice shield includes a generally flat surface adapted to generally block an injection stream distal of the distal end orifice to prevent the injector assembly from administering injectate to a subject at a sufficient pressure to pierce the skin.

28. A multi-use, needle-free injector assembly having a proximal end and a distal end, the distal end having a distal end orifice, an injection piston located generally within an injector lumen, comprising:

(a) a removable cap generally distal to the distal end orifice, wherein the distal end orifice is distal to the injector lumen, the cap further including a cap distal face and a cap proximal face; and

(b) a means for preventing the injection piston from moving from a locked position to a discharged position wherein said means are partially located distal to the distal end orifice and

(c) wherein said means are in the locked position when the cap is removed and said means are in the discharged position when said cap is in place.

29. The injector assembly of claim 28, wherein the means for preventing the injection piston from moving includes at least one of an orifice shield, a piston lock, and a latch.

30. The injector assembly of claim 29, wherein a film is disposed over a cap orifice.

31. The injector assembly of claim 30, wherein the film comprises at least one of a plastic, rubber, polymer, polyethylene, polytetrafloroethylene, polyurethane, polyolefin, polypropylene, and polysulfone material;

or combination thereof.

32. The injector assembly of claim 31, wherein the cap proximal face is disconnectedly connected to the means for preventing the injection piston from moving.

33. A method of preventing the accidental injection of medication into a patient and reducing the risks of cross contamination during injections, comprising the steps of:

(a) loading a cap onto a distal end of an injector having a distal end orifice

thereby disengaging a locking mechanism partially located distal to the distal end orifice to permit a stream of medication to exit the injector; and

(b) removing the cap after injection

thereby engaging the locking mechanism to prevent a discharge of the medication.