US3796218A

US3796218A - Syringe adaptor for use with a wet/dry mixing vial

Info

Publication number: US3796218A
Authority: US
Inventors: G Burke; K Raines
Original assignee: Burron Medical Products Inc
Current assignee: Burron Medical Products Inc
Priority date: 1972-03-28
Filing date: 1972-03-28
Publication date: 1974-03-12
Anticipated expiration: 1991-03-12

Abstract

A syringe adaptor for use with a wet/dry mixing vial having two chambers therein separated from one another by a displaceable plug and each containing a different material to be admixed with the other, comprising an elongate relatively rigid piercing tip having a pointed end and a tubular base, an open end on the tubular base for attachment of the adaptor to a syringe or the like, and a finger grip on the tubular base for grasping the adaptor to insert the piercing tip into the vial. The length of the piercing tip is such as to engage and displace a plug within the vial when the tip is inserted to thus enable said materials to be admixed, and a passageway is in the tubular base for withdrawing the admixed materials from the vial and into a syringe attached to the adaptor.

Description

Uited States Patent Burke et a1.

[ Mar. 12, 1974 1 SYRINGE ADAPTOR FOR USE WITH A WET/DRY MIXING VIAL [73] Burron Medical Products, 1nc.,

Bethlehem, Pa.

Filed: Mar. 28, 1972 Appl. No.: 238,831

Assignee:

[52] US. Cl. 128/272, 128/221, 128/218 M [51] Int. Cl. A61j 5/00, A6lm 5/32 [58] Field of Search 128/215, 214 R, 214.2,

128/214.4, 215, 218 M, 214 C, 214 D, 218 N,

128/221, 341, 343, 239, 273, DIG. 28; 222/80-82; 141/19, 25, 329

sea

lmluu-tumnr 3,206,080 9/1965 Scislowicz 128/215 X 3,077,194 2/1963 Walden et al 128/239 X 3,316,908 5/1967 Burke 222/81 X 2,117,469 5/1938 Woodyatt 128/221 Primary Examiner-Richard A. Gaudet Assistant Examiner.1. C. McGowan Attorney, Agent, or FirmShoemaker and Mattare [57] ABSTRACT A syringe adaptor for use vwith a wet/dry mixing vial having two chambers therein separated from one another by a displaceable plug and each containing a different material to be admixed with the other, comprising an elongate relatively rigid piercing tip having a pointed end and a tubular base, an open end on the tubular base for attachment of the adaptor to a syringe or the like, and a finger grip on the tubular base for grasping the adaptor to insert the piercing tip into the vial. The length of the piercing tip is such as to engage and displace a plug within the vial when the tip is inserted to thus enable said materials to be admixed, and a passageway is in the tubular base for withdrawing the admixed materials from the vial and into a syringe attached to the adaptor.

19 Claims, 11 Drawing Figures PAIENIED MAR 1 2 i974 SHEEI 1 BF 3 SYRINGE ADAPTOR FOR USE WITH A WET/DRY MIXING VIAL BACKGROUND OF THE INVENTION This invention relates to an attachment or adaptor for joining a syringe or the like to an ampoule or vial which has a displaceable plug therein dividing the vial into two chambers for containing different materials to be admixed. The attachment or adaptor includes an elongate relatively rigid tip for insertion into the vial to displace the plug therein and thus enable the materials to be admixed, a tubular base having attaching means for attachment of the adaptor to a syringe or the like, and passage means in the base through which the admixed material is withdrawn from the vial and into the syringe or the like.

There are many substances known in the prior art which are not stable for any substantial period of time when they are in solution. For example, many medicaments are not stable for any substantial period of time when they are in the form of a solution, and such medications or medicaments are normally supplied to a physician in dry form and the physician reconstitutes or mixes the medication by adding a diluent or solvent to the dry material immediately prior to injecting the medication into a patient or the like. Alternatively, such medicaments are supplied in the prior art in vials or ampoules having a displaceable plug therein dividing the interior of the vial into two chambers, one of which contains a dry powder and the other of which contains a diluent or solvent for the powder. In these prior art vials, it is necessary to first displace the plug so that the materials can be admixed within the vial, and a syringe or the like is then inserted into the vial for withdrawing the admixed medicaments or other materials. For example, it is common practice to squeeze the vial to displace the plug after which the materials are admixed by shaking the vial and a sharpened cannula on a syringe is then inserted into the vial to withdraw the admixed materials. In other prior art devices, specially modified syringes are provided having a particularly constructed vial within a modified barrel of the syringe and with piercing means for piercing the vial to cause displacement of a separating plug to admix the material therein. Still other prior art devices utilize an elongated piercing device which is inserted into the vial to displace the plug therein and then withdrawn and the materials are admixed and then a syringe or the like is inserted into the vial for withdrawing the medication.

With the present invention, a simple and economical adaptor is provided which has means on one end thereof for quickly and easily attaching the adaptor to a syringe or the like and means on the other end thereof for readily piercing a two-chamber vial or ampoule and displacing a plug therein to enable admixing ofa plurality of different materials contained within the chambers of the vial. The adaptor has passage means therein through which the admixed material is withdrawn from the vial and into the syringe or the like. Accordingly, with the present invention, complicated syringe or vial structures are rendered unnecessary, and it is not necessary to provide separate means for displacing a plug within the vial prior to insertion of the needle of a syringe therewithin to withdraw the admixed medication therefrom. In the prior art devices, it is difficult to maintain sterile conditions because of the several separate devices or the complicated structures required, and furthermore, the prior art devices are expensive to manufacture and time consuming to use due to their complexity.

OBJECTS OF THE INVENTION It is an object of this invention to provide a syringe adaptor for use with wet/dry mixing vials having a displaceable plug therein dividing the interior of the vial into two chambers, each of which contains a different material to be admixed with the other within the vial.

Another object of this invention is to provide a syringe adaptor for use with wet/dry mixing vials, which include an elongate piercing tip on one end thereof for penetration into the vial and engagement with and displacement of a plug therein to enable admixing of various materials within the vial, and which has a tubular base means having attaching means thereon for attaching the adaptor to a syringe or the like and passage means therein for withdrawing the admixed materials from the vial and into a syringe or the like attached to the adaptor.

An even further object of this invention is to provide a syringe adaptor for use with wet/dry mixing vials wherein the adaptor includes means for attachment thereto of a syringe or the like and means for penetrating the vial to displace a plug therein to enable admixing of various materials within the vial, said adaptor having means for maintaining sterile conditions to prevent contamination of the medicament or other material in the vial or of the syringe itself.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top perspective view ofa first form of syringe adaptor.

FIG. 2 is an enlarged front plan view of the syringe adaptor of FIG. 1.

FIG. 3 is an enlarged view in section taken along lines 33 in FIG. 2.

FIG. 4 is a view in section taken along lines 4-4 in FIG. 3.

FIG. 5 is a top perspective view of a second form of syringe adaptor.

FIG. 6 is an enlarged front plan view similar to FIG. 2 of the syringe adaptor of FIG. 5.

FIG. 7 is an enlarged view in section taken along line 7-7 in FIG. 6.

FIG. 8 is a perspective view of the sleeve stopper means of FIG. 7.

FIG. 9 is a top perspective view of an extension guard means for the form of the invention illustrated in FIGS. 5 through 8.

FIG. 10 is an enlarged view in section of the syringe adaptor of FIG. 7 with the extension guard means of FIG. 9 connected thereto.

FIG. 11 is a vertical sectional view of a typical vial or ampoule having a displaceable plug therein and showing the piercing tip of any of the forms of the invention described herein engaging and displacing the plug.

DETAILED DESCRIPTION OF THE INVENTION In the drawings, wherein like reference numerals refer to like parts throughout the several views, a first form of syringe adaptor is indicated generally at A in FIG. 1 and comprises an elongate tubular body I having an elongate, relatively rigid piercing tip 2 on one end thereof and an open, diametrically enlarged tubular end 3 at the other end thereof. A plurality of circumferentially spaced, axially extending reinforcing ribs 4 are on the outer surface of tubular body 1 for rigidifying and reinforcing the tubular body.

A diametrically enlarged circular collar or stop 5 is on the forward end of tubular body 1 at the base of piercing tip 2. The base 6 of the piercing tip 2 is of substantially the same outer diameter as the tubular body 1, and is tapered conically inwardly at its forward end to the piercing tip 2. A plurality of converging, axially extending, circumferentially spaced reinforcing ribs 7 extend from the forward end of base 6 to adjacent the outer end of the tip 2.

An axial bore 8 extends from the conical end of the base 6 of piercing tip 2 completely through the tubular body 1 for receiving an elongated cannula C of a conventional syringe or the like S. The diametrically enlarged tubular portion 3 at the rearward end of the tubular body 1 forms an internal tapered shoulder 9 which engages the end of the syringe S to limit the distance which the cannula C can be inserted into the bore 8 to prevent the pointed end of the cannula from engaging and piercing the base 6 of the piercing tip 2 of the adaptor. A diametrically enlarged annular flange 10 is on the open end of tubular body I to facilitate positioning of the adaptor onto the end of the syringe S. An annular sealing ring or gasket G is in an annular recess R in the enlarged end 3 of body 1 for effecting a seal between the body 1 and the hub of syringe S to prevent the liquid entering the bore 8 from displacing air therefrom and thus rendering the device inoperative. A second seal comprising a cup-shaped rubber insert I is fixed in bore 8 intermediate the ends thereof to prevent the liquid from displacing air from the bore 8. The cannula C simply pierces the insert when in use. Either one ofthese seals may be omitted, if desired, since they will each perform the required sealing, but the insert I may be preferred since the seal between two plastic parts, as at G, tends to relax.

An opening or fluid passageway 11 is in the conical end of base 6 of piercing tip 2 for establishing communication between the bore 8 in the tubular body and the interior of a vial or ampoule in which the piercing tip 2 is inserted.

In use, the end 3 of adaptor A is positioned on the end of a syringe S or the like and the piercing tip 2 is inserted into a vial or ampoule as indicated in FIG. 11, and the length of the piercing tip 2 is such as to engage and displace a plug P positioned within the ampoule or vial V and dividing the ampoule or vial into two

chambers

12 and 13 containing a diluent D and dry powder or other material M. The collar or stop 5 on the forward end of tubular body 1 serves as an abutment for the fingers to facilitate insertion of the piercing tip 2 into the vial V and also serves as a stop to limit the dis tance which the piercing tip 2 can be inserted into the vial. The base 6 of the piercing tip effects a seal with the end of the vial through which the piercing tip is inserted to prevent leakage of the material.

After the diluent D and dry material M are thoroughly admixed within the vial, a plunger or the like in the syringe or the like S is manipulated to withdraw the admixed materials from the vial V through the passageway 11 and into the cannula C and syringe S for administration of the medicament or other admixed material to a patient or the like.

A modified syringe adaptor is indicated generally at Al in FIGS. 5 through 8, and includes an elongate, relatively rigid piercing tip 2 having axially extending, circumferentially spaced reinforcing ribs 7 thereon and a diametrically enlarged cylindrical base 6 with an opening or fluid passageway 11 in the forward conical end thereof as in the previous embodiment. A relatively large annular collar or stop 5 is at the base of the piercing tip 2, and rather than the elongate tubular body 1 as in the previous embodiment, a cup-shaped tubular body 14 extends axially rearwardly from adjacent the periphery of the collar or stop 5'. A relatively short, tubular, axial extension 15 of the base 6 of piercing tip 2 extends rearwardly into the cup-shaped body 14, and a sleeve stopper 16 of rubber or plastic or other material is positioned over the axial extension 15 to effect a seal therewith.

As seen in FIGS. 7 and 8, the sleeve stopper 16 includes a pair of axially forwardly projecting

annular walls

17 and 18 spaced radially apart and with the inner wall 17 positioned interiorly of the axial tubular extension 15 and the outer wall 18 positioned exteriorly of the tubular extension 15. The forward end of wall 18 engages the rear surface of the collar or stop 5 and the length of the wall 18 is substantially the same as the length of the axial tubular extension 15 so that the end of the extension 15 engages with the bottom of the space between

walls

17 and 18. The annular wall 17 is slightly tapered and defines a cavity or chamber 19 which forms an extension or enlargement of the bore 8 in the base 6 of the piercing tip 2.

An annular rib 20 is formed on the center of the rearward end of sleeve stopper 16 to define an injection or insertion site 21 in the sleeve stopper for insertion of the sharpened cannula C therethrough and into the bore 8 of the base 6 of piercing tip 2. In this form of the invention, for example, the adaptor is used with a relatively short cannula C as compared with the elongate cannula C of the first described form of the invention.

As indicated in phantom lines in FIG. 7, a cup-shaped cap or guard G may be positioned on the rearward end of body 14 to maintain the interior of the body in sterile condition until time of use. Similarly, a cover or guard G may be provided over the piercing tip 2 for protecting the piercing tip and maintaining it sterile until the time of use thereof.

In use of this form of the invention, the cap or guard G and guard G are removed and a cannula C inserted through the sleeve stopper 16 into the bore 8 at the base 6 of the piercing tip 2. The piercing tip 2 is inserted then into a vial V as before, and the admixed material withdrawn through the opening or passageway 11 of the bore 8 and the cannula C into the syringe S or the like. The enlarged cup-shaped body 14 and the periphery of the collar or stop 5' serves as an effective finger grip means to facilitate handling of the adaptor and insertion of the piercing tip 2 into the vial V.

In FIGS. 9 through 10, a modification of the form of the invention illustrated in FIGS. 5 through 8 is indicated generally at A2 and comprises a piercing tip 2 having axial, radially spaced reinforcing ribs 7 thereon, an enlarged tubular base 6 with a bore 8 therein, and an inlet opening or fluid passage 11 through the end of the base 6 as in the previously described embodiments. An enlarged annular collar or stop 5' having an axial rearwardly extending cup-shaped body 14 extending from adjacent the periphery thereof, and an axially extending tubular extension with a sleeve stopper 16 positioned thereover and effecting a seal therewith are all provided as in the form of the invention illustrated in FIGS. 5 through 8. In addition, a tubular extension or guard 22 is fitted to the open rearward end of body 14 and comprises an elongate tubular body 23 having substantially the same diameter as the base 6 of piercing tip 2. The rearward end of body 23 is enlarged at 24 for engaging and gripping the end of a syringe S or the like. The enlarged end 24 has an internal conical shoulder 25 therein as in the form of the invention illus trated in FIGS. 1 through 4. The forward end of body 23 has a diametrically enlarged annular wall or flange 26 thereon of substantially the same diameter as the diameter of body 14. An axially forwardly projecting annular wall 27 is on the forward side of flange 26 spaced slightly inwardly from the periphery thereof and is fitted within the open end of body 14. The open end of body 14 is suitably secured and sealed to the flange or wall 26 as, for example, with a sonic seal, or a snap fit, or with a suitable adhesive or the like. An elongate bore 8' is formed axially through the guard 22.

In use of the adaptor A2, a cannula C is inserted axially through the bore 8 in body 23 and through the sleeve stopper 16 into bore 8 in base 6. The piercing tip 2 is then inserted into a vial V as aforedescribed to engage and displace the plug P therein to enable the materials within the vial to be admixed. A plunger or the like in the syringe S or the like is then manipulated to withdraw the admixed material through the passageway II, and bore 8 and into cannula C.

The form of the invention illustrated in FIGS. 9 and 10 is intended for use with relatively long needles or cannulas C as is the form of the invention illustrated in FIGS. 1 through 4.

A suitable cap or stopper, not shown, is normally engaged with the end 3 of body 1 or the end 24 of body 23 to seal the adaptor to maintain sterile conditions therewithin. Also, a suitable protective guard or cover G may be provided in each of the forms of the invention for protecting and maintaining the piercing tip 2 in a sterile condition. Further, the adaptor in each of the forms of the invention described herein is perferably made of white polypropylene and the vial V is preferably made of a transparent plastic material.

Accordingly, the present invention provides a simple and economical adaptor for a syringe or a drip chamber or the like to connect the syringe or the like with a vial or ampoule containing materials to be admixed and wherein the adaptor has means thereon for penetrating the vial to engage and displace a plug therewithin dividing the vial into two chambers containing diverse materials, so that the diverse materials may be admixed, said piercing tip having passage means therein through which the admixed material is withdrawn from the vial and into the cannula of a syringe or other means. The adaptor in each of the forms of the invention is easily manipulated and is constructed to maintain sterile conditions prior to and during use thereof.

Further, the materials in the vial are always sealed from the atmosphere when the adaptor of the present invention is used, and accordingly, there is no danger of contamination of the materials contained in the vial even when the materials are withdrawn from the vial with the present invention.

As this invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, the present embodiment is therefore illustrative and not restrictive, since the scope of the invention is defined by the apended claims rather than by the description preceding them, and all changes that fall within the metes and bounds of the claims or that form their functional as well as conjointly cooperative equivalents, are therefore intended to be embraced by those claims.

What is claimed is:

1. A syringe adaptor for use with a wet/dry mixing vial having two chambers therein separated from one another by a displaceable plug and each containing a different material to be admixed with the other, comprising an elongate tubular body open at one end, means on said open end to receive and hold a cannula therein, a substantially conically shaped end wall closing the other end of the body, an axially extending opening through said end wall communicating with the hollow interior of the body, an elongate, solid piercing tip integral at one end thereof with said end wall and extending axially outwardly therefrom to a point at the other end thereof, a plurality of axially extending, circumferentially spaced reinforcing ribs on said piercing tip and tapering inwardly from said end wall toward said point, and radially outwardly extending finger grip means on said tubular body between the ends thereof.

2. A syringe adaptor as in claim 1, wherein the adaptor is made of white polypropylene.

3. A syringe adaptor as in claim 1, wherein said tubular body is of substantially the same diameter as the base of the tip and an axial bore extends from within the base in communication with the passageway through the rearward end of the body.

4. A syringe adaptor as in claim 1, wherein the open end of the body is diametrically enlarged for gripping engagement with a syringe or the like having a cannula thereon to attach the adaptor to the syringe with the cannula extending axially into said axial bore to adjacent the tip.

5. A syringe adaptor as in claim 4, wherein a diametrically enlarged annular flange is on said body and serves as a stop and finger engaging means to facilitate insertion of the tip into a vial.

6. A syringe adaptor as in claim 5, wherein a plurality of axially extending circumferentially spaced reinforcing ribs are on the tubular body.

7. A syringe adaptor as in claim 4, wherein an annular sealing ring is in a groove in the enlarged portion of said body to effect a seal between said body and asyringe to which the adaptor is attached and thus prevent liquid entering said hollow interior of said body from displacing air therefrom.

8. A syringe adaptor as in claim 4, wherein a substantially cup-shaped rubber insert is fixed in said hollow interior of said body intermediate the ends thereof, said insert being adapted to be pierced by a cannula extended into said hollow interior and to effect a seal therewith to thus prevent liquid entering said hollow interior of said body from displacing air therefrom.

9. A syringe adaptor as in claim 1, wherein the reinforcing ribs on the tip are tapered toward the point thereof and terminate short of the point.

10. A syringe adaptor as in claim 1, wherein said fin: ger grip means comprises a cup-shaped tubular body extending axially rearwardly from adjacent the periphery of a diametrically enlarged annular flange on the body adjacent the tip, said cup-shaped tubular body being of larger diameter than the elongate body.

11. A syringe adaptor as in claim 10, wherein said open end of said elongate body extends co-axially rearwardly within the tubular body, said elongate body being of substantially constant diameter, and said projection being shorter in length than the tubular body and having an open rearward end.

12. A syringe adaptor as in claim 11, wherein a sleeve stopper is on the open end of the elongate body effecting a seal therewith.

13. A syringe adaptor as in claim 12, wherein said sleeve stopper has a thickened end wall and a pair of radially spaced, axially forwardly extending cylindrical walls, said open end of said elongate body being received therebetween with the thickened wall positioned over the open end of the body.

14. A syringe adaptor as in claim 13, wherein an annular rib is on the rearward surface of said thickened end wall defining an insertion site for a cannula on a syringe or the like, the length of the elongate body, and the combined thickness of the thickened end wall and rib being such as to space the end of the cannula from the conically shaped end wall of the tip.

15. A syringe adaptor as in claim 14, wherein a tubular axial extension is connected at one end thereof to the rearward end of the cup-shaped tubular body and extends rearwardly therefrom.

16. A syringe adaptor as in claim 15, wherein the other end of the axial extension has means for receiving and gripping the end of a syringe or the like.

17. A syringe adaptor as in claim 16, wherein said one end of said extension has a diametrically enlarged annular flange thereon, the marginal peripheral portion of said flange being secured and sealed to the rearward end portion of said cup-shaped tubular body.

18. A syringe adaptor as in claim 17, wherein said flange has a forwardly axially extending annular wall thereon spaced radially inwardly from the periphery thereof and fitted and sealed within the rearward end of said cup-shaped tubular body.

19. A syringe adaptor as in claim 18, wherein the combined lengths of the axial extension, the cupshaped tubular body, and the elongate body are such as to space the end of a cannula on the end of a syringe or the like attachedto the adaptor from the conically shaped end wall of piercing tip.

Claims

7. A syringe adaptor as in claim 4, wherein an annular sealing ring is in a groove in the enlarged portion of said body to effect a seal between said body and a syringe to which the adaptor is attached and thus prevent liquid entering said hollow interior of said body from displacing air therefrom.

10. A syringe adaptor as in claim 1, wherein said finger grip means comprises a cup-shaped tubular body extending axially rearwardly from adjacent the periphery of a diametrically enlarged annular flange on the body adjacent the tip, said cup-shaped tubular body being of larger diameter than the elongate body.

19. A syringe adaptor as in claim 18, wherein the combined lengths of the axial extension, the cup-shaped tubular body, and the elongate body are such as to space the end of a cannula on the end of a syringe or the like attached to the adaptor from the conically shaped end wall of piercing tip.