Safety needle and method of using same

• US 5,256,152 A
• Filed: 03/11/1992
• Issued: 10/26/1993
• Est. Priority Date: 10/29/1991
• Status: Expired due to Term

• Current Assignee: Lloyd A. Marks
• Original Assignee: Lloyd A. Marks
• Inventors: Marks, Lloyd A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/850,959
• Time in Patent Office: 594 Days
• Field of Search: 128/919, 604/110, 604/192, 604/198, 604/263
• US Class Current: 604/198
• CPC Class Codes: A61M 2005/3249 Means to disalign the needle tip and the distal needle passage of a needle protection sleeve
• CPC Class Codes: A61M 2005/325 Means obstructing the needle passage at distal end of a needle protection sleeve
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
• CPC Class Codes: A61M 5/3257 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 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
• CPC Class Codes: Y10S 128/919 Syringe, means to protect user

Abstract

A safety hypodermic needle and a method of using the same are disclosed. The safety needle comprises a hypodermic needle and a protective sheath molded of an flexible polymeric material. The protective sheath comprises a needle cup which encloses the sharp needle point and is supported on a plurality of outwardly flexed ribs. The needle cup has a needle opening which is misaligned with the needle axis in the at rest or unflexed condition of the protective sheath. Application of transverse and axial forces to the needle cup aligns the needle with the opening and cause the ribs to bow outwardly so that the needle passes through the opening and into the patient'"'"'s body.

Claims

1. A safety needle for insertion into the body of a patient comprising a hypodermic needle having a needle axis and a needle point and being mounted in a needle support, a protective sheath having an axis and comprising a needle cup enclosing the needle point and a mounting sleeve for mounting said sheath to the needle support, flexible means for supporting said needle cup from said mounting sleeve, said flexible means comprising at least two ribs each having two ends, each rib being connected at one end to said mounting sleeve and at the other end to said needle cup, said needle being disposed between said two ribs, said needle cup having a needle opening through which the needle is adapted to pass, said ribs having an unflexed, at rest position and a flexed position such that in the unflexed position the needle axis is misaligned with the needle opening and the ribs are spaced from and disposed substantially parallel to the needle and in the flexed position the needle axis is aligned with the needle opening and the ribs are bowed outwardly away from each other on opposite sides of the needle, said ribs being automatically movable from the flexed position to the unflexed position when the needle is withdrawn from the body of the patient so as to automatically position the needle cup relative to the needle such that the needle axis is misaligned with the needle opening.

2. The safety needle of claim 1, including latching means on said protective sheath for releasably latching the protective sheath in its flexed position with the needle extending at least partly through the needle opening.

3. The safety needle of claim 2, wherein said needle cup has an end cover, said needle opening being disposed in said end cover, said latching means comprising a tab attached to said needle cup, said tab having at least one opening therein, and a pin engageable in said tab opening, said pin being affixed to said mounting sleeve.

4. The safety needle of claim 3, wherein said tab is integrally formed with the needle cup and the pin is integrally formed with the mounting sleeve.

5. The safety needle of claim 2, wherein said latching means comprises a tab attached to said needle cup for manually aligning the needle opening with the needle axis and for manually moving the needle cup so that said needle passes at least partly through the needle opening.

6. The safety needle of claim 5, wherein said tab has at least one opening therein and a pin on said protective sheath for releasably engaging in the tab opening.

7. The safety needle of claim 2, wherein said needle cup has four sides and a rectangular cross-section, said needle opening being disposed in a first side of said needle cup, said latching means comprising a tab attached to a second side of said needle cup opposite said first side.

8. The safety needle of claim 7, wherein said protective sheath comprises a mounting sleeve having a rectangular cross-section, said flexible means comprising at least two ribs connecting a third and fourth sides of said needle cup to said mounting sleeve.

9. The safety needle of claim 8, wherein said ribs extend from said mounting sleeve to said needle cup at an angle relative to the needle axis.

10. The safety needle of claim 1, wherein the axis of the protective sheath is laterally offset from the needle axis to misalign the needle axis with the needle opening.

11. The safety needle of claim 1, including a slot in said needle cup adjacent the opening thereof through which said needle is adapted to pass when said protective sheath is moved from its unflexed position to its flexed position.

12. The safety needle of claim 1, wherein the needle axis is inclined with respect to the axis of the protective sheath to misalign the needle axis with the needle opening.

13. The safety needle of claim 1, wherein said protective sheath is molded of a polymeric material.

14. The safety needle of claim 13, wherein the polymeric material of at least said needle cup is transparent.

15. The safety needle of claim 13, wherein the protective sheath is molded in one piece, said ribs having the same length and a uniform cross-sectional area from end to end.

16. The safety needle of claim 1, including a catheter tube disposed over said needle, said needle opening being a size sufficient for the catheter tube to pass completely through the needle opening.

17. A safety needle comprising a hypodermic needle having a needle axis and a needle point and being mounted in a needle support, a protective sheath surrounding said needle and having an axis misaligned with the needle axis, said sheath comprising a needle cup enclosing the needle point, a mounting sleeve mounting the sheath to the needle support, and at least two flexible ribs each having two ends, each rib being connected at one end to said mounting sleeve and at the other end to said needle cup, said needle cup having a needle opening through which the needle is adapted to pass, said ribs having an unflexed position and a flexed position such that in the unflexed position the ribs are disposed in spaced, substantially parallel relation to the needle and the needle axis is misaligned with the needle opening, and in the flexed position the ribs are bowed outwardly away from the needle and from each other and the needle is aligned with and extends through the needle opening, said ribs being automatically returnable from the flexed position to the unflexed position so as to automatically position the needle cup relative to the needle such that the needle axis is again misaligned with the needle opening.

18. A protective sheath for a hypodermic needle having a needle axis and a needle point and being mounted in a needle support, said sheath comprising a mounting sleeve for mounting the sheath to the needle support, a needle cup adapted to enclose the needle point, said needle cup comprising a front cup portion and a rear cup portion, hinge means for hingedly connecting the cup portions together, at least one flexible rib connecting said mounting sleeve to said rear cup portion, said front cup portion having an end cover adapted to confront the needle point in a first position thereof, a tab connected to said front cup portion for pivoting said front cup portion about the hinge means from said first position away from the rear cup portion to a second position exposing the needle point of said needle.

19. The protective sheath of claim 18, including means for releasably locking said cup portions together.

20. The protective sheath of claim 19, wherein said locking means comprises a finger on one of said cup portions engageable in an opening on the other of said cup portions.

21. The protective sheath of claim 18, including means affixed to and cooperating between said tab and said mounting sleeve for latching said front cup portion in said second position.

22. The protective sheath of claim 18, wherein said protective sheath is molded in one piece from a polymeric material.

23. A method of using a safety needle comprising a hypodermic needle having a needle axis and a needle point and being mounted in a needle support, a protective sheath having an axis and comprising a needle cup enclosing the needle point and a mounting sleeve for mounting the sheath to said needle support, flexible means supporting said needle cup from said mounting sleeve, said flexible means comprising at least two ribs each having two ends, each rib being connected at one end to said mounting sleeve and at the other end to said needle cup such that said needle is disposed between said two ribs, said needle cup having a needle opening through which the needle is adapted to pass, said ribs having an unflexed, at rest position in which the needle axis is misaligned with the needle opening and the ribs are disposed substantially parallel to the needle axis and a flexed position in which the needle axis is aligned with the needle opening and the ribs are outwardly bowed away from each other on opposite sides of the needle, said method comprising the steps of:

engaging the body of a patient with the needle cup.

pressing the needle cup against the patient'"'"'s body in a direction to urge the needle and needle cup relatively of each other until the needle axis is aligned with the needle opening;

pressing the needle cup against the patient'"'"'s body in a direction to urge the needle cup axially of the protective sheath to flex the ribs outwardly away from the needle axis and away from one another and move the needle through the needle opening and into the body of the patient; and

removing the needle from the body of the patient and the needle cup away from contact with the body of the patient to permit the ribs to automatically return to the unflexed, at rest position and automatically misalign the needle axis with the needle opening of the needle cup.

24. The method of claim 23, wherein a catheter tube is disposed over the needle and including the steps of inserting the needle point into a blood vessel in the body of the patient and sliding the catheter tube axially off the needle and into the blood vessel and removing the needle and protective sheath from the body while leaving the catheter tube in the blood vessel.

25. A method of using a safety needle comprising a hypodermic needle having a needle axis and a needle point and being mounted in a needle support, a protective sheath having an axis and comprising a needle cup enclosing the needle point and a mounting sleeve for mounting the sheath to said needle support, flexible means supporting said needle cup from said mounting sleeve, said flexible means comprising at least two ribs each having two ends, each rib being connected at one end to said mounting sleeve and at the other end to said needle cup such that said needle is disposed between said two ribs, said needle cup having a needle opening through which the needle is adapted to pass, said ribs having an unflexed, at rest position in which the needle axis is misaligned with the needle opening and the ribs are disposed substantially parallel to the needle axis and a flexed position in which the needle axis is aligned with the needle opening and the ribs are outwardly bowed away from each other on opposite side of the needle, a tab attached to the needle cup and having an opening and a pin attached to the protective sheath, said method comprising the steps of:

grasping the tab;

manually moving the needle cup with the tab until the needle passes through the needle opening to expose the needle;

engaging the pin with the tab opening to releasably retain the needle exposed;

inserting the needle in the body of a patient;

engaging the body of the patient with the needle cup to thereby release the pin from the tab opening; and

withdrawing the needle from the patient'"'"'s body and the needle cup away from contact with the body of the patient to permit the ribs to automatically return to the unflexed, at rest position and automatically misalign the needle axis with the needle opening of the needle cup.

26. The method of claim 25, wherein a catheter tube is disposed over the needle and including the steps of inserting the needle point into a blood vessel in the body of the patient and sliding the catheter tube axially off the needle and into the blood vessel and removing the needle and protective sheath from the body while leaving the catheter tube in the blood vessel.