Syringe safety device

• US 20060184103A1
• Filed: 02/17/2005
• Published: 08/17/2006
• Est. Priority Date: 02/17/2005
• Status: Abandoned Application

• Current Assignee: West Pharmaceutical Services Incorporated
• Original Assignee: West Pharmaceutical Services Incorporated
• Inventors: Norton, Paul, Paproski, John
• Application Number:
  US11/059,729
• Publication Number:
  US 20060184103A1
• Time in Patent Office: Days
• US Class Current: 604/86
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle

Abstract

A syringe safety device configured to form a fluid coupling between a sealed vial and a syringe having a barrel for receiving fluid and a luer cone extending from the barrel for dispensing the fluid therethrough. The luer cone has a distal end with a syringe orifice therethrough. A connector includes a vial end and a syringe end. The syringe is removably mountable to the syringe end and the vial is mountable to the vial end. A tip cap is removably mounted to the luer cone of the syringe. The tip cap and the distal end define an open receiving space therebetween. A needle is removably mounted to the connector. The needle includes a needle tip facing toward the syringe in an assembled configuration. The needle tip is positioned in the receiving space when the connector and syringe are positioned in an engaged position.

Claims

1. A syringe safety device configured to form a fluid coupling between a sealed vial and a syringe having a barrel for receiving fluid and a luer cone extending from the barrel for dispensing the fluid therethrough, the luer cone having a distal end with a syringe orifice therethrough, the syringe safety device comprising:

a connector including a vial end and a syringe end, the syringe removably mountable to the syringe end and the vial being mountable to the vial end;

a tip cap removably mounted to the luer cone of the syringe, the tip cap and the distal end defining an open receiving space therebetween; and

a needle removably mounted to the connector, the needle including a needle tip facing toward the syringe in an assembled configuration, the needle tip being positioned in the receiving space when the connector and syringe are positioned in an engaged position.

2. The syringe safety device of claim 1 further comprising:

a sliding linkage movably mounted within the connector, the sliding linkage being movable along a connector axis, the needle being mounted to the sliding linkage.

3. The syringe safety device of claim 1 further comprising:

a sliding piston movably mounted within the connector, the sliding piston being movable along a connector axis; and

a syringe luer lock releasably mounted to the sliding piston and the luer cone of the syringe to align the needle with the receiving space.

4. The syringe safety device of claim 1 wherein the tip cap is comprised of a generally cylindrical sleeve and a generally planar penetration wall that is positioned on a plane generally perpendicular to the connector axis in the engaged position, the syringe orifice, the receiving space and the needle defining at least a portion of a sterile fluid passageway between the syringe and vial in the engaged position.

5. The syringe safety device of claim 4 wherein the tip cap includes a locating shoulder formed on an inner surface of the sleeve, the luer cone having a generally cylindrical-shape, the distal end contacting the locating shoulder to position the tip cap relative to the luer cone in the engaged position.

6. The syringe safety device of claim 1 wherein the tip cap is constructed of a polymeric material.

7. The syringe safety device of claim 1 further comprising:

a double needle assembly including the needle mounted to a first end of a housing and a vial needle and a vent needle mounted to a second end of the housing, the needle, vial needle and vent needle located generally parallel to a connector axis of the connector in an assembled configuration.

8. A tip cap for a syringe that limits contact between the syringe and a needle tip wherein the needle tip penetrates the tip cap to one of dispense medication our of the syringe and draw medication into the syringe, the syringe including a luer cone extending from a barrel, the tip cap comprising:

a penetration wall; and

a generally cylindrical sleeve extending generally perpendicularly from the penetration wall adjacent a periphery of the penetration wall, the cylindrical sleeve including a radially inwardly extending locating shoulder on an inner surface located a predetermined distance from the penetration wall, the locating shoulder engaging an end of the luer cone in an operating position, the penetration wall, cylindrical sleeve and luer cone defining a receiving space within which the needle tip is positionable.

9. The tip cap of claim 8 wherein the tip cap is constructed of a self-healing, polymeric material.

10. The tip cap of claim 8 wherein the cylindrical sleeve includes a tip mouth, the tip mouth contacting a syringe luer lock which is mounted to the luer cone in the operating position, the contact between the tip mouth and the luer lock further positioning the tip cap relative to the end of the luer cone.

11. The tip cap of claim 8 wherein an inner surface of the cylindrical sleeve on an engaging portion of the sleeve tapers away from a connector axis.

12. The tip cap of claim 8 wherein the engaging portion is force fit onto the luer cone.

13. A syringe safety device for transferring or mixing medications between a syringe and a vial, the syringe safety device comprising:

a connector including a vial end and a syringe end, the syringe being removably mountable to the syringe end and the vial being mountable to the vial end;

a tip cap removably mountable to a luer cone of the syringe; and

at least one needle penetrating the tip cap in an engaged position and forming at least a portion of a fluid passageway between the syringe and vial, the tip cap being retained on the luer cone when a fluid has been transferred through the fluid passageway and the syringe is removed from the syringe end.

14. The syringe safety device of claim 13 further comprising:

a luer needle removably mountable to the distal end of the syringe when the tip cap is removed from the distal end.

15. The syringe safety device of claim 13 further comprising:

a syringe luer lock removably mountable at the luer cone, the syringe luer lock aligning a syringe orifice relative to a sliding piston and aligning the tip cap relative to the syringe orifice, the tip cap and syringe orifice defining a receiving space therebetween.

16. The syringe safety device of claim 15 further comprising:

a sliding linkage movably mounted within the connector; and

the at least one needle mounted to the sliding linkage, the needle including a needle tip that faces the tip cap and is positioned within the receiving space in an engaged position.

17. The syringe safety device of claim 13 further comprising:

a sliding linkage movably mounted to the connector along a connector axis and having a shoulder, the connector including a first locking mechanism and a second locking mechanism, the first and second locking mechanisms permitting a sliding piston to move in an engaging direction along the connector axis, the first and second locking mechanisms preventing the sliding piston from moving in a release direction beyond a first locking position and a second locking position once the sliding piston has moved in the engaging direction past the first and second locking positions, respectively.

18. The syringe safety device of claim 17 wherein one of the first and second locking mechanisms engages the sliding piston when the sliding piston is in one of the first and second locking positions, the syringe and tip cap being releasable from the connector and sliding piston by application of a force to the syringe in the release direction when the sliding piston is in one of the first and second locking positions.

19. A method for transferring medication between a syringe having a tip cap mounted thereon and a vial, the method comprising the steps of:

a) penetrating the tip cap with a needle to create a fluid passageway between the syringe and vial;

b) drawing a medication from the vial, through the passageway and into the syringe; and

c) removing the needle from the tip cap, the tip cap being retained on the syringe.

20. The method of claim 19 comprising the further steps of:

d) mounting the syringe, needle and vial to a connector before step (a), an audible notice sounding when the vial is mounted to the connector;

e) dispensing a diluent from the syringe into the vial through the passageway between steps (a) and (b);

f) agitating the vial following step (e) to mix the diluent with a powdered medication in the vial, mixing of the diluent and powdered medication results in an injectable medication solution; and

g) retaining the vial, needle and connector in an engaged configuration following step (c).

21. The method of claim 20 comprising the further step of:

e) disposing the vial, needle and connector following step (g).

22. The method of claim 19 wherein a needle tip of the needle is positioned in a receiving space defined by the tip cap and a distal end of a luer cone of the needle following step (a).

23. The method of claim 19 further comprising the step of:

d) removing the tip cap from the syringe;

e) mounting a blunt end of a luer needle onto the luer cone;

f) penetrating the skin of a patient with a pointed end of the luer needle; and

g) dispensing the medication into the patient through the luer needle by depressing a plunger of the syringe.

24. A method of distributing a syringe safety device having a syringe with a luer cone and a plunger, a vial and a fluid transfer assembly, the fluid transfer assembly including a connector, a sliding piston and a sliding linkage, a needle and spike being mounted to opposing ends of the sliding linkage, the method comprising the steps of:

a) at least partially filling the syringe with a diluent;

b) mounting a tip cap to the luer cone;

c) shipping the syringe with tip cap thereon to a remote location;

d) assembling the syringe with the fluid transfer assembly; and

e) delivering the assembled syringe and fluid transfer assembly to an end user.

25. The method of claim 24 comprising the further step of:

f) attaching the vial to the assembled syringe and fluid transfer assembly, an audible indication sounding when the vial is properly attached to the assembled syringe and fluid transfer assembly.

26. The method of claim 25 comprising the further steps of:

g) urging the syringe toward the vial along a connector axis such that the needle tip penetrates the tip cap and the spike penetrates the vial creating a passageway between the syringe and vial; and

h) dispensing the diluent through the passageway into the vial by depressing the plunger toward the vial along the connector axis.

27. The method of claim 26 comprising the further steps of:

i) agitating the vial such that the diluent mixes with a powdered medication in the vial creating a medication solution;

j) urging the medication solution through the passageway into the syringe by drawing the plunger away from the vial along the connector axis; and

k) removing the syringe and attached tip cap from the fluid transfer assembly.

28. The method of claim 24 comprising the further steps of:

f) packaging the syringe and tip cap in a first sterile package before step (c); and

g) removing the syringe and tip cap from the first sterile package before step (d).

29. The method of claim 24 comprising the further steps of:

f) packaging the assembled syringe and fluid transfer assembly in a second sterile package before step (e); and

g) removing the assembled syringe and fluid transfer assembly from the second sterile package following step (e).

30. A method of mixing a diluent and a powdered medication using a fluid transfer assembly, the fluid transfer assembly including a connector, a sliding piston, a sliding linkage with a needle and a spike, the fluid transfer assembly being assembled along a connector axis, the diluent being contained in a syringe having a tip cap mounted on a luer cone of the syringe and the powdered medication being contained in a vial, the method comprising the steps of:

(a) mounting the syringe to a syringe end of the fluid transfer assembly such that the syringe is movable relative to the fluid transfer assembly;

(b) mounting the vial to a vial end of the fluid transfer assembly;

(c) moving the syringe a first distance along the connector axis in an engaging direction at least until the needle penetrates the tip cap and is in fluid communication with the diluent;

(d) moving the syringe a second distance along the connector axis in the engaging direction at least until the spike is in fluid communication with the vial creating a fluid passageway between the syringe and vial;

(e) dispensing the diluent into the vial through the sterile fluid passageway;

(f) mixing the diluent and powdered medication in the vial, resulting in a medication solution;

(g) drawing the medication solution through the sterile fluid passageway into the syringe; and

(h) removing the syringe from the syringe end with the tip cap mounted on the syringe.

31. The method of claim 30 wherein the vial is mounted to the fluid transfer assembly in step (b) by urging the vial along the connector axis in a release direction and into contact with and beyond a pair of vial lock arms, the vial lock arms holding a peripheral rim of the vial between terminal ends of the vial lock arms and the connector such that the vial is prevented from moving in the engaging direction, an audible vial notice sounding when the vial lock arms engage the vial.

32. The method of claim 30 wherein the syringe is mounted to the fluid transfer assembly in step (a) by urging a distal end of the syringe into engagement with the sliding piston.

33. The method of claim 30 wherein, prior to step (a), a first audible notice indicates that the sliding piston is engaged by a first locking mechanism of the connector generally preventing the sliding piston from moving along the connector axis in a release direction beyond the first locking mechanism and at the conclusion of step (d), a second audible notice indicates that the sliding piston is engaged by a second locking mechanism preventing the sliding piston from moving along the connector axis in the release direction beyond the second locking mechanism.

34. The method of claim 31 wherein the first and second audible notices are comprised of click sounds.

35. The method of claim 31 wherein the sliding piston is in an initial position, mounted in the connector, at the conclusion of the first audible notice.

36. The method of claim 30 wherein air in the vial is urged out of the vial through an air bleed channel in the spike during step (e), the air that is urged out of the vial passes through an air filter before being released from the air bleed channel.

37. The method of claim 30 wherein external air is drawn into the vial through an air bleed channel in the spike during step (g), the air that is drawn into the air bleed channel passing through an air filter before being introduced into the vial.

38. The method of claim 30 comprising the further steps of:

(i) mounting a luer needle to the syringe;

(j) piercing a patient with the luer needle; and

(k) injecting the medication solution into the patient.

39. The method of claim 30 comprising the further steps of:

(i) removing the vial from the vial end at the conclusion of step (g);

(j) mounting a second vial to the vial end such that the spike is in fluid communication with a medication in the vial; and

(k) drawing the medication through the sterile fluid passageway into the syringe.

40. A syringe safety device configured to form a fluid coupling between a sealed vial and a syringe, the syringe safety device comprising:

a connector for receiving the sealed vial and syringe at opposite ends thereof, the connector defining a connector axis;

a sliding linkage movably mounted within the connector, the sliding linkage being movable along the connector axis;

a needle mounted to a first side of the sliding linkage on the connector axis; and

a spike mounted to a second side of the sliding linkage on the connector axis, at least one of the spike and the needle including a first luer lock connector that releasably mounts to a second luer lock connector of the sliding linkage.

41. The syringe safety device of claim 40 wherein the spike includes the first luer lock connector and the second side includes the second luer lock connector, the spike piercing a stopper of the vial and the needle piercing a tip cap on a distal end of the syringe in an engaged position, a sterile fluid passageway created between the vial and syringe through the needle, spike and sliding linkage in the engaged position.

42. The syringe safety device of claim 40 wherein the needle is adhesively bonded to the sliding linkage.

43. The syringe safety device of claim 40 further comprising:

an air filter mounted within the spike for filtering air passing to and from the vial.

44. A syringe safety device configured to form a fluid coupling between a vial and a syringe, the syringe safety device comprising:

a connector having a syringe end and a vial end, the connector defining a connector axis, the syringe being removably mountable to the syringe end and the vial being mountable to the vial end; and

a spike movably mounted to the connector, the spike being movable along the connector axis, a penetration end of the spike facing the vial end for piercing a stopper of the vial in an engaged position, the penetration end having a generally figure eight-shaped cross-sectional configuration.

45. The syringe safety device of claim 44 wherein the spike includes a fluid lumen and an air bleed lumen, the fluid lumen being positioned in a first bulbous region of the spike cross-section and the air bleed lumen being positioned in a second bulbous region of the spike cross-section.

46. The syringe safety device of claim 45 wherein the fluid lumen extends from a position adjacent a spike tip to a first luer connector on the spike, the fluid lumen defining at least a portion of a sterile fluid passageway between the syringe and the vial when the syringe safety device is in the engaged position.

47. A syringe safety device configured to form a fluid coupling between a vial and a syringe, the vial having a head defining a peripheral rim, the syringe safety device comprising:

a connector having a syringe end and a vial end, the connector defining a connector axis, the syringe being releasably mountable to the syringe end and the vial being mountable to the vial end, the connector having a generally cylindrical-shape, the connector including a lock window adjacent the vial end, a vial lock extending toward the connector axis into the lock window from a root end adjacent the vial end to a terminal end, the terminal end being in engagement with the peripheral rim when the vial is mounted to the vial end.

48. The syringe safety device of claim 47 wherein the window is comprised of a first window and a second window, the vial lock comprised of a first vial lock and a second vial lock.

49. The syringe safety device of claim 47 wherein the connector includes a vial shoulder positioned on a plane generally perpendicular relative to the connector axis and having a spike hole therein that is generally centered about the connector axis, a stopper of the vial being in facing engagement with the vial shoulder when the vial is mounted to the connector.

50. The syringe safety device of claim 49 wherein the vial shoulder includes a ring that defines the spike hole, the ring being in facing engagement with the stopper when the vial is mounted to the connector.

51. The syringe safety device of claim 47 wherein the vial lock extends from the root end to the terminal end at a locking angle, the locking angle being between thirty and fifty degrees (30°

-50°

).

52. The syringe safety device of claim 47 wherein the vial lock is resilient to permit flexure of the vial lock toward and away from the connector axis, the terminal end flexing away from the connector axis when the head of the vial is positioned adjacent to the terminal end, the terminal end snapping under the peripheral rim and creating an audible indication that the vial is secured to the connector by the vial lock in an assembled configuration.

53. The syringe safety device of claim 47 wherein the vial lock prevents the vial from moving in a release direction along the connector axis when the vial is mounted to the vial end without a force being applied to the vial lock radially outwardly relative to the connector axis.

54. The syringe safety device of claim 47 wherein the vial lock is comprised of a pair of pivot feet that a pivotably mounted to the connector, the pivot feet being manually pivotable between a grasping position and an extended position, the pivot feet being biased toward the grasping position, the pivot feet releasably mounting the vial to the vial end.