Method and apparatus for operating a syringe and vial for injections

• US 6,581,648 B1
• Filed: 09/14/2001
• Issued: 06/24/2003
• Est. Priority Date: 10/30/1998
• Status: Expired due to Fees

• Current Assignee: Immunex Corporation (Amgen Inc.)
• Original Assignee: Immunex Corporation (Amgen Inc.)
• Inventors: Zolentroff, William Carleton, Luciano, Robert C., Bode, Robert L.
• Primary Examiner(s): Douglas, Steven O.
• Application Number:
  US09/830,791
• Time in Patent Office: 648 Days
• Field of Search: 604/414, 141/2, 141/18, 141/25-27, 141/94, 141/98, 141/329, 141/330
• US Class Current: 141/2
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/3139 Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/3213 Caps placed axially onto the needle, e.g. equipped with finger protection guards axially-extensible protective sleeves A61M5/3243

Abstract

A device for aligning a vial and a syringe used for medical injections. The device includes a vial alignment portion and a syringe alignment portion, both aligned on an alignment axis extending between the two portions. The alignment portions can restrict motion of both the vial and the syringe transverse to the alignment axis so as to maintain a needle of the syringe aligned with an access port of the vial. The device can also include provisions for removing a protective cap from the vial and for removing a protective cover from the syringe needle. The syring and the vial can be packaged in a container which can also be used to align the syringe with the vial.

Claims

1. A device (24) for aligning a syringe (22) with a vial (20), the device (24) comprising a body (25) having a vial alignment portion (26) and a syringe alignment portion (28) aligned on an alignment axis (30) extending between the vial alignment portion (26) and the syringe alignment portion (28), the vial alignment portion (26) having at least one vial engagement member adapted to engage a vial (20) and align the vial with the alignment axis during operation, the syringe alignment portion (28) adapted to align a syringe (22) with the alignment axis during operation and to limit lateral displacement of the syringe from the alignment axis, the syringe alignment portion including a first guide portion and a second guide portion axially aft of the first guide portion, the first guide portion being upwardly facing, generally aligned with the alignment axis (30), and being substantially located below the alignment axis such that the first guide portion is completely open above the alignment axis, the second guide portion being integral with the first guide portion and having lateral walls extending upward beyond the first guide portion, the lateral walls defining a second opening facing transverse to the alignment axis, the second opening being smaller than the opening in the first guide portion, the first and second guide portions defining an axial sliding surface to accommodate axial sliding of a syringe (22) during use.

2. The device (24) of claim 1 wherein the syringe alignment portion (28) includes a first syringe arm (98) and a second syringe arm (98) spaced apart from the first syringe arm (98), the first and second syringe arms (98) having concave surfaces facing one another, the syringe arms being located on opposite sides of the alignment axis and axially spaced from the second guide portion.

3. The device (24) of claim 1 wherein the first guide portion is concave.

4. The device (24) of claim 1 wherein the body (25) has a cover removing portion that includes first and second cover engaging surfaces (108, 110) spaced apart from one another for claming the cover (60) therebetween.

5. The device (24) of claim 4 wherein at least one of the cover engaging surfaces (108, 110) is movable relative to the other.

6. The device (24) of claim 4 wherein at least one of the cover engaging surfaces (108, 110) includes a sharpened blade.

7. The device (24) of claim 1 wherein the body (25) includes a vial cap removing portion having a generally flat receiving surface (118) adapted to receive an upper surface of a cap (46), the cap removing portion further having an overhanging lip engaging surface (120) located above and spaced apart from the receiving surface (118).

8. The device (24) of claim 2 wherein at least one of the first and second syringe arms (98) is biased toward the other.

9. The device (24) of claim 2 wherein the maximum spacing between the first and second syringe arms (98) is less than the maximum spacing between the lateral arms of the second guide portion.

10. The device (24) of claim 1 wherein the vial engagement member includes first and second vial arms (52) spaced apart from one another on opposite sides of the alignment axis (30), at least one of the first and second vial arms (52) being biased toward the other to releasably clamp a vial (20) therebetween.

11. The device (24) of claim 1 wherein the body (25) includes a slot (104) adapted to receive a flange (90) of a handle (80), and a handle stop (105) positioned in the slot (104) and adapted to prevent rotation of the handle (80) beyond a selected position.

12. The device (24) of claim 1 wherein the syringe alignment portion (28) includes a syringe stop surface (100) adapted to prevent axial translation of a syringe (23) beyond a selected position along the alignment axis (30).

13. A method for aligning a syringe (22) with a vial (20) comprising the steps of:

securing a first vial (20) by removably engaging the first vial (20) with an alignment body (25) to at least restrict motion of the first vial (20) transverse to an alignment axis (30) extending axially from an access port (42) of the first vial (20) when the first vial is secured;

securing a first syringe (22) by laterally moving the first syringe (22) toward the alignment body (25) in a direction transverse to the alignment axis (30), engaging a barrel (56) of the first syringe (22) with a first engagement surface of the alignment body (25) which aligns the first syringe (22) with the alignment axis (30), and axially moving the first syringe (22) along the first engagement surface in general alignment with the alignment axis (30) to engage the syringe (22) with a second engagement surface which limits motion of the first syringe (22) in any direction transverse to the alignment axis (30) such that a needle (58) of the syringe (22) is aligned with and the access port (42) of the vial (20); and

reusing the alignment body (25) by removing the first vial (20) and the first syringe (22) therefrom and removably securing a second vial (20) and a second syringe (22) hereto.

14. The method of claim 13 wherein the step of securing the first vial (20) includes restricting motion of the first vial (20) along the alignment axis (30).

15. The method of claim 13 wherein the first syringe (22) includes a barrel (56), a needle (58) projecting from the barrel (56) and a cover (60) adjacent the needle (58) and removably coupled to the syringe, and wherein prior to securing the syringe, the method comprises the steps of clamping the cover (60) between first and second spaced apart cover engaging members (108, 110) of the alignment body (25) and moving the barrel (56) away from the cover (60) while the cover is clamped between the first and second cover engaging members (108, 110) to separate the cover (60) from the syringe.

16. The method of claim 15 wherein one of the cover engaging surfaces (108, 110) includes a sharpened blade and wherein the step of clamping involves moving the cover (60) into engagement with the sharpened blade.

17. The method of claim 13 wherein the first vial (20) has a removable cap (46), and wherein the method further comprises the steps of:

engaging the cap (46) with a portion of the alignment body (25); and

tilting the first vial (20) relative to the alignment body (25) to pry the cap (46) away from the first vial (20).

18. The method of claim 13 wherein the first syringe (22) includes a barrel (56) and a handle (80) attached to the barrel (56), wherein the step of securing the first syringe (22) includes engaging the handle (80) with the alignment body (25).

19. The method of claim 18 wherein the step of engaging the handle with the alignment body includes rotating the handle (80) relative to the barrel (56) about an axis generally parallel with the alignment axis (30) and receiving a flange (90) on the handle in a slot (104) of the alignment body (25).

20. The method of claim 19 wherein the slot (104) includes a handle stop (105), and wherein the step of rotating the handle includes rotating the handle (80) until the handle (80) engages the handle stop (105).

21. A device for aligning a syringe with a vial comprising:

a body having a vial alignment portion, a syringe alignment portion, and an alignment axis extending between the vial alignment portion and the syringe alignment portion;

the vial alignment portion having at least one vial engagement surface adapted to align a vial with the alignment axis and to inhibit axial displacement of the vial along the alignment axis; and

the syringe alignment portion adapted to align a syringe with the alignment axis and to limit lateral displacement of the syringe from the alignment axis, the syringe alignment portion including a guide surface formed on the body and extending along a portion of the alignment axis, the guide surface adapted to slidably guide and support a portion of a syringe, the guide surface having a forward base portion which is substantially located below the alignment axis and open above the alignment axis for laterally receiving a syringe, and two lateral guide surfaces located on opposite sides of the alignment axis aft of the forward base portion, the lateral guide surfaces each including a portion which projects toward the other to define a gap, the gap being located above the alignment axis and having a width that is less than the width of the opening in the forward base portion, the lateral guide surfaces adapted to limit lateral displacement of a syringe.

22. The device of claim 21 wherein the lateral guide surfaces are integrally attached to the base portion such that the combination defined a generally C-shaped channel for receiving a portion of a syringe.

23. The device of claim 21 wherein the syringe alignment portion includes two alignment arms spaced apart from one another on opposite sides of the alignment axis, the alignment arms being located on the body at an axially spaced apart location from the lateral guide surfaces.

24. The device of claim 23 wherein at least one of the first and second alignment arms is biased toward the other.

25. The device of claim 23 wherein the first and second alignment arms are formed integral with the body.

26. The device of claim 21 wherein the vial alignment portion and the syringe alignment portion are formed on one side of the body, and wherein the opposite side of the body includes cavities for storing at least one syringe and at least one vial.

27. The device of claim 21 wherein the vial alignment portion includes a compartment having a lateral width dimension sized to receive a body of a vial, and wherein the at least one vial engagement surface is a vial stop wall located at one end of the compartment, the stop wall having a curved aperture that has a width dimension that is less than the a width of the compartment.

28. The device of claim 21 wherein the at least one vial engagement member includes first and second vial arms spaced apart from one another on opposite sides of the alignment axis, at least one of the first and second vial arms being biased toward the other.

29. The device of claim 28 wherein the first and second vial arms are formed integral with the body.

30. The device of claim 21 wherein the body has a cover removing portion that includes first and second cover engaging surfaces spaced apart to clamp a cover therebetween.

31. The device of claim 30 wherein at least one of the cover engaging surfaces is movable relative to the other.

32. The device of claim 21 wherein the body includes a vial cap removing portion having a generally flat receiving surface adapted to receive the upper surface of the cap, the cap removing portion further having an overhanging lip engaging surface located above and spaced apart from the receiving surface.

33. A device for aligning a syringe with a vial comprising:

a body having a vial alignment portion, a syringe alignment portion, and an alignment axis extending between the vial alignment portion and the syringe alignment portion;

the vial alignment portion having at least one vial engagement surface adapted to align a vial with the alignment axis and to inhibit axial displacement of the vial along the alignment axis; and

the syringe alignment portion adapted to align a syringe with the alignment axis and to limit lateral displacement of the syringe from the alignment axis, the syringe alignment portion including a channel adapted to slidingly guide a syringe along the alignment axis, the channel having a substantially semi-cylindrical shape, the channel having a forward guide portion which is substantially open on one side of the alignment axis, and two lateral guide surfaces extending upward from the channel aft of the forward guide portion, the lateral guide surfaces curving inward toward one another, the lateral guide surfaces having upper edges which define a gap that is less than the side opening in the forward guide portion, the lateral guide surfaces adapted to inhibit lateral displacement of a syringe.

34. A method for aligning a syringe with a vial comprising the steps of:

providing an alignment body having a vial alignment portion, a syringe alignment portion and an alignment axis extending between the vial alignment portion and the syringe alignment portion;

securing a vial to the vial alignment portion by removably engaging the vial with the alignment body to limit movement of the vial transverse to an alignment axis; and

securing a syringe to the syringe alignment portion by laterally moving the syringe toward the alignment body in a direction transverse to the alignment axis to engage a barrel of the syringe with a first guide surface formed on the alignment body which aligns the syringe with the alignment axis, and axially sliding the syringe along the first guide surface in a direction substantially along the alignment axis causing the syringe to engage with a second engagement surface which limits motion of the syringe transverse to the alignment axis, the securing of the syringe placing a needle of the syringe in alignment with an access port of the vial.