Strong diaphragm/safe needle units and components for transfer of fluids

• US 6,221,056 B1
• Filed: 12/19/1997
• Issued: 04/24/2001
• Est. Priority Date: 12/20/1996
• Status: Expired due to Term

• Current Assignee: David G. Silverman
• Original Assignee: David G. Silverman
• Inventors: Silverman, David G.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US08/994,959
• Time in Patent Office: 1,222 Days
• Field of Search: 604/181, 604/117, 604/170, 604/239, 604/256, 604/272, 604/274, 604/275, 604/905, 604/93.01, 604/167.01, 604/167.02, 604/167.04
• US Class Current: 604/239
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/321 Means for protection against accidental injuries by used needles
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3271 with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Abstract

A needle has a blunted tip and a recessed orifice to avoid unintentional needle sticks and user contact with inoculum contained in the needle. A diaphragm is designed for use with the relatively blunt tip needle so that the needle easily penetrates the diaphragm at a force substantially lower than the force required to puncture skin, preferably at most 50% of the force required to puncture skin.

Claims

1. A strong diaphragm/safe needle unit comprising:

a needle with a closed, solid tip and a longitudinal through-bore for fluidic communication from a proximal hub to at least one distal orifice, the at least one distal orifice being in communication with the bore of the needle and recessed from the solid tip;

wherein the solid tip is tapered at an angle of approximately between 45° and

75°

to a longitudinal axis of the needle; and

an elastically deformable diaphragm which is penetrable by the needle with a clinically acceptable force and which provides effective, leak-free closure after penetration.

2. The unit of claim 1, wherein the needle has a curved outlet passage for allowing an inoculum to exit from the needle.

3. The unit of claim 1, wherein the breaking strength of the diaphragm is substantially less than that of skin.

4. The unit of claim 1, wherein the breaking strength of the diaphragm is substantially less than that of skin.

5. The unit of claim 1, wherein the needle is covered by a sheath which in a resting state covers the at least one orifice and upon advancement of the needle through a diaphragm retracts to expose said orifice.

6. The unit of claim 1, wherein the diaphragm is substantially leakfree prior to initial use.

7. The unit of claim 1, wherein the diaphragm is not substantially damaged after engagement of the unit with the diaphragm.

8. The unit of claim 1, wherein the needle and diaphragm are mutually engageable upon said penetration.

9. The unit of claim 1, wherein the diaphragm has effective sealing after a single insertion and removal with the needle.

10. The unit of claim 1, wherein the diaphragm has effective sealing after multiple insertions and removals with the needle.

11. The unit of claim 1, wherein the diaphragm has effective sealing after a single insertion and removal with a sharp needle.

12. The unit of claim 1, wherein the diaphragm has effective sealing after multiple insertions and removals with a sharp needle.

13. The unit of claim 1, wherein the diaphragm has a slit or array of slits to facilitate penetration, wherein said slit or array extends partially through the thickness of the diaphragm.

14. The unit of claim 13, wherein the slit or array is extendable completely through the diaphragm by insertion of the needle.

15. The unit of claim 1, wherein the diaphragm has a hole to facilitate penetration, wherein said hole extends wholly through the thickness of the diaphragm.

16. The unit of claim 1, wherein the diaphragm has a weakened region to facilitate penetration.

17. The unit of claim 1, wherein the diaphragm is adaptable to cover bottles, tubes, bags, heparin locks and injection ports.

18. The unit of claim 1, wherein the diaphragm is penetrable by the needle.

19. The unit of claim 1, further comprising an injection site identifier carried by a housing of said diaphragm having indicia for identifying an injection site which is penetrable by the needle.

20. The unit of claim 19, wherein an intact surface of the diaphragm prior to penetration is wipeable without contamination.

21. The unit of claim 1, wherein the diaphragm has a slit or array of slits to facilitate penetration, wherein said slit or array of slits extends completely through the thickness of the diaphragm.

22. The unit of claim 1, wherein the diaphragm has a hole to facilitate penetration, wherein said hole extends partially through the thickness of the diaphragm.

23. The unit of claim 1, wherein said solid tip has a pointed end.

24. The unit of claim 1, wherein said solid tip has a rounded end.

25. The unit of claim 1, wherein said solid tip has a flat end.

26. A method of using a needle and a diaphragm,

wherein the needle has a solid tip and at least one longitudinal bore which terminates in one or more orifices which are in communication with the bore of the needle and recessed from the solid needle tip, and the diaphragm forms a seal on top of a container, and

wherein the solid tip is tapered at an angle of approximately between 45°

and 75°

to a longitudinal axis of the needle;

the method comprising the steps of;

puncturing the diaphragm with the solid tip of the needle; and

moving the solid tip of the needle through the diaphragm and advancing the one or more orifices into the container.

27. The method of claim 26, wherein said solid tip has a pointed end.

28. The method of claim 26, wherein said solid tip has a rounded end.

29. The method of claim 26, wherein said solid tip has a flat end.