Safety syringe

• US 5,613,952 A
• Filed: 06/07/1995
• Issued: 03/25/1997
• Est. Priority Date: 12/23/1991
• Status: Expired due to Term

• Current Assignee: Retractable Technologies Incorporated
• Original Assignee: Syringe Development Partners LLC
• Inventors: Vaughn, Charles A. Sr., Pressly, William B. S. Sr., Ellis, Thomas R., Brockway, G. Samuel
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/481,093
• Time in Patent Office: 657 Days
• Field of Search: 604/110, 604/195, 604/192, 604/187, 604/263, 604/198, 604/207, 604/218, 604/111, 604/222
• US Class Current: 604/110
• CPC Class Codes: A61M 2005/3101 Leak prevention means for proximal end of syringes, i.e. syringe end opposite to needle mounting end
• CPC Class Codes: A61M 2005/3103 Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
• CPC Class Codes: A61M 2005/3106 Plugs for syringes without needle
• CPC Class Codes: A61M 2005/3223 Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2005/3224 Means to disalign the needle tip and syringe nozzle
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/502 for blocking the piston
• CPC Class Codes: A61M 5/508 Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

Abstract

A syringe apparatus and process for using the same is provided, the syringe apparatus having a barrel, a plunger movable within the barrel, a needle assembly attached to an end of the barrel and having a passageway therethrough, a deformable base positioned within the barrel, flexible supports included on the deformable base, a spring within the passageway of the needle assembly, a hollow needle passing through the passageway, an enlarged head on the needle, and a rupturable web on an end of the plunger, whereby when the plunger moves through the barrel toward the needle assembly, a fluid can be moved from the barrel through the hollow of the needle, and continued movement of the plunger flexes the supports and moves the deformable base downwardly until such time a sufficient force is imparted to the rupturable web by the enlarged head to tear the web, the deformable base then releasing the needle due to force applied by the spring to project the needle into the interior of the plunger. Seals are provided for making a liquid impervious seal on both ends of the syringe after the needle is retracted. The seal on the end left open by needle retraction is a closing member which can be used to seal off the opening without placing a user'"'"'s hands in front of the opening. The syringe includes indicia that is revealed upon needle retraction to label the syringe as a biohazard. A syringe apparatus using a deformable base, enlarged needle head and needle assembly of an alternative embodiment is also provided wherein sacrificial supports in the needle assembly are utilized and severed by the deformable base.

Claims

1. A syringe apparatus comprising:

a barrel;

a plunger movable within said barrel;

a needle assembly attached to an end of said barrel and defining a passageway therethrough;

a deformable base positioned within said barrel adjacent said needle assembly and defining a passage therethrough;

flexible supports included on said deformable base;

energy storage means within said passageway;

a hollow needle passing through said passageway;

an enlarged head on said needle engaged within said passage of said deformable base; and

a rupturable web on an end of said plunger for moving a fluid within said barrel through the hollow of said needle when said plunger is moved through said barrel toward said needle assembly;

whereby when said plunger moves through said barrel toward said needle assembly, a fluid can be moved from said barrel through the hollow of said needle, and continued movement of said plunger flexes said supports and moves said deformable base downwardly until such time as sufficient force is imparted to said rupturable web by said enlarged head of said needle to tear said rupturable web, said deformable base then releasing said needle with said enlarged head due to force applied thereto by said energy storage means to project said needle with said enlarged head into the interior of said plunger.

2. The apparatus according to claim 1 wherein said enlarged head is generally matingly engaged by said deformable base.

3. The apparatus according to claim 1 wherein said plunger is hollow on the interior thereof for receipt of said needle and said enlarged head and further comprising means within said plunger for capturing said enlarged head of said needle when it is projected thereinto.

4. The apparatus according to claim 1 wherein said energy storage means is a spring.

5. The apparatus according to claim 1 wherein said flexible supports constitute an end of said deformable base and each includes an engaging flange on an end thereof.

6. The apparatus according to claim 5 wherein said deformable base is fitted against a shelf defined within said barrel at an end of said deformable base opposite said flexible supports.

7. The apparatus according to claim 1 wherein said flexible supports contact an end of said needle assembly.

8. The apparatus according to claim 1 wherein said rupturable web is part of a boot positioned over said end of said plunger.

9. The apparatus according to claims 1 or 3 wherein said rupturable web comprises at least one tear groove.

10. The apparatus according to claim 1 wherein said enlarged needle head comprises a flat and diametrically cylindrical top.

11. The apparatus according to claims 1 or 10 wherein said enlarged needle head is generally cylindrical and includes a plurality of areas diametrically wider than a remainder of said enlarged needle head.

12. The apparatus according to claim 1 wherein said needle assembly is attached to said barrel whereby said needle assembly partially extends into said barrel.

13. The apparatus according to claim 12 wherein said plunger has an enlarged operating head which is matingly receivable within an end of said barrel opposite said needle assembly.

14. The apparatus according to claim 1 further comprising a plunger seal for providing a liquid impervious seal between said plunger and said barrel at an end of said barrel opposite said needle assembly when said operating head of said plunger is received within said barrel.

15. The apparatus according to claim 14 wherein said plunger seal is an O-ring positioned within a groove on said plunger.

16. The apparatus according to claim 1 further comprising a needle guard positioned over said needle assembly.

17. The apparatus according to claim 16 further comprising a closing member for attachment to an end of said needle assembly to provide a liquid impervious seal therebetween, and wherein said closing member is removably attached to an end of said needle guard at an angle whereby said closing member can be attached to said needle assembly and removed from said needle guard without handling said closing member.

18. The apparatus according to claim 1 wherein said barrel has indicia thereon which is positioned above said deformable base when said rupturable web is intact.

19. The apparatus according to claim 18 wherein said indicia and said deformable base are of substantially identical colors.

20. The apparatus according to claim 19 wherein said boot is a contrasting color to a color of said indicia.

21. The apparatus according to claim 1 further comprising means for revealing an indicia on said barrel.

22. A syringe apparatus comprising:

a barrel;

a hollow needle extending from an end of said barrel;

a plunger movable within said barrel for moving a fluid out of said barrel through said needle;

said plunger receivable within an end of said barrel opposite said needle; and

a seal for providing a liquid impervious seal between said plunger and said barrel approximately at an end of said barrel opposite said needle.

23. The apparatus according to claim 22 wherein said seal is an O-ring positioned within a groove defined on said plunger.

24. A syringe apparatus comprising:

a barrel having an indicia thereon said indicia being covered by a shield;

a hollow needle extending from an end of said barrel;

a plunger movable within said barrel; and

means for displacing said shield, thereby making said indicia readable upon movement of said plunger within said barrel.

25. The apparatus according to claim 24 wherein said barrel is generally transparent and said means for making said indicia readable comprises moving a component associated with said plunger of contrasting color to a color of said indicia below said indicia by movement of said plunger to make said indicia readable.

26. A syringe comprising:

a barrel having a first end and an opposite second end;

a plunger having a forward end and movable within said barrel from said second end of the barrel towards said first end, the plunger having a hollow interior communicating with said forward end;

a deformable base within said barrel intermediate said first and second end;

a hollow needle having a pointed front, said needle extending through said first end of said barrel and a rear end received within and supported by said deformable base;

energy storage means positioned in said barrel between said first end said deformable base and in engagement with said needle; and

a rupturable web on said forward end of the plunger;

wherein a fluid can move from within said barrel through said needle as said plunger moves through said barrel to said deformable base, and when said rupturable web contacts said deformable base, continued movement of said plunger moves said deformable base toward said first end, said rear end of said needle thereby tearing said web wherein said rear end loses contact with said deformable base to allow said energy storage means to eject said needle into said interior of said plunger.

27. The apparatus according to claim 26 wherein said deformable base comprises flexible supports at an end thereof closest to said first end of said barrel.

28. The apparatus according to claim 27 further comprising a needle assembly attached to said first end of said barrel, said needle passing therethrough, and wherein said flexible supports are positioned against an end of said needle assembly opposite said pointed front prior to needle ejection.

29. The apparatus according to claim 28 wherein said deformable base and said needle assembly are of sizes so that said flexible supports can flex to surround said needle assembly and said needle assembly can pass within said deformable base as said deformable base moves toward said first end.

30. A process for retracting a needle upon completion of subcutaneous injection with a hypodermic syringe comprising the steps of:

forcing a plunger of a syringe downwardly within said syringe to force a deformable base engaging a head of said needle downwardly around said head;

forcing an end portion of said head to tear a base portion of said plunger; and

propelling said needle into a hollow of said plunger.

31. The process according to claim 30 wherein said deformable base includes flexible supports and wherein said flexible supports are forced to flex away from one another prior to forcing said deformable base downwardly around said head.

32. The process according to claim 31 wherein said flexible supports are forced against a needle assembly through which said needle passes to force them to flex and wherein said supports flex just enough to pass around said needle assembly.

33. The process according to claim 30 further comprising capturing said needle within said hollow.

34. The process according to claim 30 further comprising sealing said plunger and said syringe to provide a liquid impervious seal to prevent any liquids therein from exiting.

35. The process according to claim 30 further comprising revealing a predetermined indicia on said syringe after said needle has been propelled into said hollow.

36. A process for plugging a passage left open by needle ejection in a syringe comprising the steps of:

providing a syringe having a passage with an opening left open by needle ejection;

providing a needle guard for covering said needle prior to needle ejection, said needle guard having a closing member for closing and sealing said passage opening attached thereto at an angle;

sealing off said passage opening by grasping said needle guard and attaching said closing member to said passage opening; and

removing said needle guard from said closing member.

37. The process according to claim 36 wherein the step of sealing off said passage opening is accomplished wherein a user'"'"'s hands and fingers remain behind said passage opening.

38. A syringe apparatus comprising:

a barrel;

a plunger movable within said barrel;

a needle assembly attached to an end of said barrel and defining a passageway therethrough;

a deformable base positioned within said barrel adjacent said needle assembly and defining a passage therethrough;

energy storage means within said passageway;

a hollow needle passing through said passageway;

an enlarged head on said needle engaged within said passage of said deformable base; and

a rupturable web on an end of said plunger for moving a fluid within said barrel through the hollow of said needle when said plunger is moved through said barrel toward said needle assembly;

whereby when said plunger moves through said barrel toward said needle assembly, a fluid can be moved from said barrel through the hollow of said needle, and continued movement of said plunger moves said deformable base downwardly until such time as sufficient force is imparted to said rupturable web by said enlarged head of said needle to tear said rupturable web, said deformable base then releasing said needle with said enlarged head due to force applied thereto by said energy storage means to project said needle with said enlarged head into the interior of said plunger.

39. The apparatus according to claim 38 wherein said enlarged needle head is cylindrical.

40. The apparatus according to claim 38 wherein said deformable base is cylindrical.