Blister syringe with optional bifurcated guard

• US 6,585,693 B1
• Filed: 07/30/2001
• Issued: 07/01/2003
• Est. Priority Date: 07/30/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Dischler, Louis
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): Ragonese, Andrea M.
• Application Number:
  US09/918,411
• Time in Patent Office: 701 Days
• Field of Search: 604/110, 604/111, 604/171, 604/181-183, 604/185, 604/187, 604/192, 604/195, 604/197-202, 604/212, 604/217, 604/244, 604/263, 420/542.8
• US Class Current: 604/171
• CPC Class Codes: A61J 1/067 Flexible ampoules, the contents of which are expelled by squeezing
• 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 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
• CPC Class Codes: A61M 5/3219 Semi-automatic repositioning of the cap, i.e. in which the repositioning of the cap to the needle covering position requires a deliberate action by the user to trigger the repositioning of the cap, e.g. manual release of spring-biased cap repositioning means

Abstract

The present invention provides a unitary syringe having a mounted needle surrounded by a sheath having a break-zone. The fluid medicament to be injected is contained within a blister cavity formed between upper and lower polymeric layers. Accidental needle sticks are reduced by optional guard fingers surrounding the needle. These fingers extend past the and bracket the sharpened end of the needle.

Claims

1. A syringe for use with a target surface to be injected, comprising:

a needle comprising a sharpened distal end, a proximal end, and a fluid channel therebetween;

a primary cavity in fluid communication with said fluid channel, said primary cavity comprising at least one deformable wall;

a first flexible guard comprising a first base and a first tip, said first base substantially fixed relative to said needle, and said first tip extending past said sharpened distal end; and

a second flexible guard comprising a second base and a second tip, said second base substantially fixed relative to said needle, and said second tip extending past said sharpened distal end;

wherein said sharpened distal end resides substantially between and behind said first tip and said second tip when the syringe is not in use; and

wherein said first tip and said second tip make contact the with target surface to be injected prior to said sharpened distal end when the syringe is in use.

2. A syringe as recited in claim 1, wherein said needle comprises a proximal sheath base surrounding at least a portion of said proximal end of said needle.

3. A syringe as recited in claim 2, further comprising a needle sheath, said needle sheath comprising:

a closed or sealed distal sheath end and an open proximal sheath end, said needle sheath enclosing said sharpened distal end of said needle, said open proximal sheath end sealed to said proximal sheath base; and

a break-zone.

4. A syringe as recited in claim 2, further comprising:

a needle sheath, said needle sheath comprising a closed or sealed distal sheath end and an open proximal sheath end, said needle sheath enclosing said sharpened distal end of said needle, said open proximal sheath end transitioning into said proximal sheath base, and comprising a weakened portion therebetween, whereby said weakened portion may be broken by twisting said needle sheath relative to said proximal sheath base.

5. A syringe as recited in claim 2, further comprising:

a needle sheath, said needle sheath comprising a closed or sealed distal sheath end, an open proximal sheath end and a break-zone, said needle sheath enclosing said sharpened distal end of said needle, and said open proximal end sealing to said proximal sheath base.

6. A syringe as recited in claim 1, wherein said primary cavity is substantially filled with a liquid.

7. A syringe as recited in claim 6, wherein said liquid is under a positive pressure relative to atmospheric pressure.

8. A syringe as recited in claim 7, wherein said primary cavity comprises a surface indicator portion having positive curvature under said positive pressure, and negative curvature when said positive pressure is released, whereby the integrity of said liquid is indicated prior to use.

9. A syringe as recited in claim 8, wherein said surface indicator portion is a section of a sphere or ellipsoid.

10. A syringe as recited in claim 1, wherein said primary cavity comprises a first polymeric layer and a second polymeric layer, said first polymeric layer sealed to said second polymeric layer to form said primary cavity therebetween.

11. A syringe as recited in claim 10, wherein said first flexible guard and said second flexible guard are formed from at least one of said first polymeric layer and said second polymeric layer.

12. A syringe as recited in claim 1, further comprising:

a sealed secondary cavity not in fluid communication with said primary cavity, said secondary cavity comprising at least one deformable wall; and

a channel in fluid communication with said secondary cavity, said channel comprising a break-zone.

13. A syringe as recited in claim 12, wherein said break-zone can be broken by twisting.

14. A syringe, comprising:

a needle comprising a sharpened distal end, a proximal end, and a fluid channel therebetween;

a primary cavity in fluid communication with said fluid channel, said primary cavity comprising a first flexible polymeric layer and a second polymeric layer forming said primary cavity therebetween;

a needle sheath, said needle sheath comprising a closed or sealed distal sheath end and an open proximal sheath end, said needle sheath enclosing said needle, said open proximal end sealed to said proximal end of said needle with a first fluid tight seal;

a first break-zone located in said needle sheath, whereby twisting of said distal sheath end of said needle sheath separates said sheath from the syringe to expose said sharpened end of said needle;

a first flexible guard comprising a first base and a first tip, said first base substantially fixed relative to said needle, and said first tip extending past said sharpened distal end; and

a second flexible guard comprising a second base and a second tip, said second base substantially fixed relative to said needle, and said second tip extending past said sharpened distal end;

wherein said sharpened distal end resides substantially in a first plane with said first flexible guard and said second flexible guard when the syringe is not in use.

15. A syringe as recited in claim 14, wherein said primary cavity is substantially filled with a first liquid.

16. A syringe as recited in claim 15, wherein said first liquid is under a positive pressure relative to standard atmospheric pressure.

17. A syringe as recited in claim 16, wherein said primary cavity comprises a surface portion having positive curvature under said positive pressure, and negative curvature when said positive pressure is released.

18. A syringe as recited in claim 14, further comprising:

a secondary cavity not in fluid communication with said primary cavity, said secondary cavity comprising at least one deformable wall; and

a secondary channel in fluid communication with said secondary cavity, said secondary channel comprising a second break-zone.

19. A syringe as recited in claim 18, wherein said second break-zone can be broken by twisting.

20. A syringe, comprising:

a body comprising an upper layer and a lower layer;

a needle comprising an axis, a sharpened distal end, a proximal end, and a fluid channel along said axis, said proximal end sealed to said body;

a primary cavity between said upper and lower layers, wherein said primary cavity is in fluid communication with said fluid channel of said needle; and

a first flexible guard comprising a first base and a first tip, said first base substantially fixed relative to said needle, and said first tip extending past said sharpened distal end;

a second flexible guard comprising a second base and a second tip, said second base substantially fixed relative to said needle, and said second tip extending past said sharpened distal end; and

wherein said sharpened distal end resides substantially between and behind said first tip and said second tip when the syringe is not in use.

21. A syringe as recited in claim 20, further comprising:

a secondary cavity not in fluid communication with said primary cavity, said secondary cavity comprising at least one deformable wall;

a secondary channel in fluid communication with said secondary cavity, said secondary channel comprising a break-zone;

a fluid tight seal opposite said break-zone from said secondary cavity.

22. A syringe as recited in claim 20, further comprising:

a needle sheath, said needle sheath comprising a closed or sealed distal sheath end and an open proximal sheath end, said needle sheath enclosing said needle, said open proximal end sealed to said proximal end of said needle with a first fluid tight seal; and

a first break-zone located in said needle sheath, whereby twisting of said distal sheath end of said needle sheath separates said sheath from the syringe to expose said sharpened end of said needle.

23. A syringe, comprising:

a syringe body;

a hollow needle comprising a sharpened tip and a base, said base fixed to said syringe body;

a fluid chamber within said syringe base, wherein said fluid chamber is in fluid communication with said needle; and

a bifurcated guard extending from said syringe body, said bifurcated guard comprising first and second tips that extend past said sharpened end of said needle, said first and second tips lying on either side of said needle in a first plane.

24. A syringe as recited in claim 23, further comprising sheath means for protecting said needle.

25. A syringe as recited in claim 24, wherein said syringe body is comprised of a first polymeric layer and a second polymeric layer sealed together to form said fluid chamber.

26. A syringe as recited in claim 25, wherein said fluid chamber is penetrated by said base.

27. A syringe as recited in claim 25, wherein said first polymeric layer and said second polymeric layer are sealed around at least said sharpened tip of said needle to form a needle sheath, said needle sheath having a weakened portion to serve as a break-zone.

28. A syringe as recited in claim 25, wherein the syringe is attached to at least a second like syringe by a thinned web formed of at least one of said first polymeric layer and said second polymeric layer.