MIXING VIAL

Abstract

A method for buffering anesthetic.

Claims

1.-8. (canceled)

9. A mixing vial for use in a cartridge syringe, the mixing vial comprising: a vessel, the vessel comprising a hollow interior chamber having a proximal end and an open distal end; a stopper including an open first end, a closed second end opposite and spaced apart from the open first end, and at least one stopper side wall extending from the open first end to the closed second end, wherein a hollow interior chamber is defined by the at least one stopper side wall and the closed second end, the stopper being positioned in a sealing relationship with a portion of an inner surface of the hollow interior chamber of the vessel, wherein an outer surface of the at least one stopper side wall includes two or more ribs extending radially outwardly from the at least one stopper side wall, wherein each of the two or more ribs are axially spaced apart from each other, wherein an inner surface of the at least one stopper side wall defines a circumferentially extending groove, wherein the groove is located axially between two adjacent ribs of the two or more ribs; and a dislodgeable plug disposed within hollow interior chamber of the stopper such that at least a portion of an edge of the dislodgeable plug is disposed with the groove of the stopper, wherein the entire dislodgeable plug is fully dislodgeable as a single piece from the open first end of the stopper.

10. The mixing vial of claim 9, wherein the two or more ribs comprises three or more ribs.

11. The mixing vial of claim 10, further comprising a piston slidably positioned in the proximal end of the hollow interior chamber of the vessel.

12. The mixing vial of claim 11, wherein the piston comprises a hollow recess in a distal face.

13. The mixing vial of claim 10, wherein the closed second end of the stopper and the at least one stopper side wall are formed as a single piece.

14. The mixing vial of claim 10, wherein the stopper is a stopper-piston slidably positioned in a sealing relationship with the hollow interior chamber of the vessel.

15. The mixing vial of claim 10, wherein the vessel has an interior diameter that is uniform.

16. The mixing vial of claim 10, wherein the stopper further includes a radially inwardly extending flange, wherein the flange defines the groove.

17. The mixing vial of claim 10, wherein the hollow interior chamber of the vessel comprises an anesthetic, and the hollow interior chamber of the stopper comprises a buffering reagent.

18. The mixing vial of claim 10, wherein the cartridge syringe comprises a dental syringe, the vessel comprising a shape that allows use with the dental syringe.

19. The mixing vial of claim 10, wherein the stopper comprises an elastomeric plastic or rubber.

20. The mixing vial of claim 10, wherein the syringe needle pierces the stopper and dislodges the dislodgeable plug when the mixing vial is loaded into or placed in the cartridge syringe.

21. The mixing vial of claim 10, wherein the closed second end of the stopper includes a radially outwardly extending annular flange.

22. A syringe system, the system comprising: a syringe including a body, a syringe needle, and an axially movable plunger, the syringe needle being statically coupled to the distal end of the body, the syringe needle having a distal end and a proximal end; and the mixing vial of claim 10, wherein, when the mixing vial is disposed in the syringe, the proximal end of the syringe needle is able to penetrate the closed second end of the stopper, contact the dislodgeable plug, and fully dislodge the dislodgeable plug.

23. The system of claim 22, wherein the syringe comprises a dental syringe, the vessel comprising a shape that allows use with the dental syringe.

24. The system of claim 22, wherein the syringe needle pierces the stopper and dislodges the dislodgeable plug when the mixing vial is loaded into or placed in the cartridge syringe.

25. A syringe system, the system comprising: a syringe with an axially movable plunger having a distal end defining a shoulder, wherein a harpoon extends axially from the distal end of the plunger, wherein the shoulder has a larger diameter than a harpoon minimum diameter, wherein the harpoon is static with respect to the plunger; and the mixing vial of claim 14, wherein, when the mixing vial is disposed in the syringe and the plunger is axially moved, the harpoon penetrates the closed second end of the stopper-piston, contacts the dislodgeable plug, and fully dislodges the dislodgeable plug prior to the shoulder of the plunger contacting the closed second end of the stopper-piston.

26. The system of claim 25, wherein the syringe comprises a dental syringe, the vessel comprising a shape that allows use with the dental syringe.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 is a side elevation of a conventional needle/syringe apparatus for use in combination with a vial of the present invention;

[0021] FIG. 2 is a perspective view of a conventional vial having a single chamber;

[0022] FIG. 3 is an exploded, sectional view, in vertical section, of an embodiment of a mixing vial of the present invention with its dislodgeable plug in sealing position and a needle, broken away;

[0023] FIG. 4 is a sectional view, in vertical section, of an embodiment of FIG. 3 with its plug dislodged and a needle, shown broken away, the needle having been inserted into the vial to dislodge the plug;

[0024] FIG. 5 is a side elevation of a conventional dental cartridge needle/syringe apparatus for use in combination with a cartridge of the present invention;

[0025] FIG. 6 is an exploded sectional view, broken away, of the conventional dental cartridge needle/syringe apparatus of FIG. 5;

[0026] FIG. 7 is a perspective view of a conventional dental cartridge having a single chamber;

[0027] FIG. 8 is a sectional view of an embodiment of a mixing vial of the present invention in cartridge form with a needle inserted therein, the needle shown broken away;

[0028] FIG. 9A is a sectional view of an embodiment of FIG. 8, with a needle inserted therein, the needle shown broken away, after the harpoon-plunger of the syringe has been inserted into and through the hollow chambered piston and dislodged the plug;

[0029] FIG. 9B is a sectional view of an embodiment of FIG. 8, with a needle inserted therein, the needle shown broken away, and the blunt pushrod of the syringe has elongated the membrane of the stopper and dislodged the plug; and

[0030] FIG. 10 is a sectional view, broken away, of an embodiment of a mixing vial of the present invention in cartridge form with a needle inserted therein, the needle having dislodged the plug to effect mixing of the two chambers' contents.

DESCRIPTION OF THE INVENTION

[0031] Now referring to the drawings, a conventional prior art syringe/needle apparatus is illustrated in FIG. 1 while a conventional prior art vial is illustrated in FIG. 2. The syringe/needle apparatus of FIG. 1 is suitable for use in conjunction with an embodiment of the mixing vial of the present invention as will be described in more detail in the following disclosure. The conventional prior art vial does not have dual chambers or a plug and is shown for illustrative purposes.

[0032] FIGS. 3 and 4 illustrate a mixing vial of the present invention which is indicated by the numeral 10. Mixing vial 10 provides the ability for physicians to buffer local anesthetic prior to injection in a manner that is economically feasible, is not excessively time-consuming, does not interfere with established surgical protocol, and does not require new or unfamiliar surgical equipment.

[0033] Broadly speaking, mixing vial 10 is a generally barrel shaped vessel 12 having a hollow interior chamber 14 and neck 16 having distal and proximal open ends, 18 and 20. An elastomeric, chambered stopper 22 is positioned in neck 16 and is in sealing relationship with interior facing wall 24 of neck 16.

[0034] Chambered stopper 22 has a hollow interior chamber 26 and an open proximal end 28 with a dislodgeable plug 30 positioned in and sealing said open end 28. Thus, annular edge 32 of plug 30 is tightly fit into annular groove 34 in radially inwardly extending stopper flange 36 of stopper 22. Vessel 12 may be made of glass, plastic or any other material suitable for use consistent with the purpose of the present invention.

[0035] Stopper 22 may be made of elastomeric plastic or rubber material, including the typical vial stopper material in present use, which will seal well with adjacent surfaces. Plug 30 may be made of PTFE, or any material or combination of materials suitable for sealing with stopper 22 and resisting penetration of the needle. For instance, plug 30 may have an elastomeric body and edge, with a PTFE strike plate 31 attached to the needle side to prevent needle penetration.

[0036] Stopper 22 has a radially outwardly extending annular flange 38 and is retained in position on neck 16 by metal clip 40 which clips onto annular shoulder 42 on neck 16 and compresses flange 38 against distal face 45 of neck 16.

[0037] As shown in FIGS. 3 and 4, interior chamber 14 of vessel 12 contains solution 50, for example, a local anesthetic solution, or a physiologic saline solution. Interior chamber 26 of stopper 22 contains a powder 52, for example, NaHCO3, or a powdered steroid medication.

[0038] In operation, the mixing vial 10 of the present invention is used in accordance with the following method. First, a mixing vial of the present invention is provided and its two chambers filled with suitable drugs or other materials which are desired to be kept separate and then mixed just before injection. Then, the vial is inverted and, using a typical disposable medical syringe 53 as illustrated in FIG. 1, the physician inserts the Syringe Needle 55 into the chambered stopper 22 as illustrated in FIGS. 3 and 4.

[0039] The physician must make certain that the Syringe Needle passes through chamber 26 of stopper 22 and dislodges plug 30 into the chamber 14 of mixing vial 10. The dislodged plug 30 may float to the top of the mixed solution, or alternatively be configured to stay in solution to aid in mixing the drugs. Also, vial 10 may be shaken to assist in mixing. Coloring or clouding reagents may be added to either chamber to provide visual indication of mixing or premature seal failure. The form of the Chambered Vial Stopper assembly allows elimination of headspace gas in one or the other of the chambers. The physician withdraws the mixed drug solution from the inverted vial into the syringe apparatus and administers it to the patient in the typical manner.

[0040] Now referring to FIGS. 5 and 6 a conventional syringe 57 for use with vials configured as cartridges such as the conventional dental cartridge 59 shown in FIG. 7 is illustrated. The conventional cartridge syringe is also useful for use with a cartridge style mixing vial of the present invention as further described below.

[0041] As shown in FIGS. 8, 9A, and 9B, mixing vial 110 is in the form of a cartridge and has a generally barrel shaped vessel 112 having a hollow interior chamber 114 and neck 116, and having distal and proximal open ends, 118 and 120. Neck 116 is a portion of vessel 112 at the proximal end thereof and is simply an extension of the vessel's tubular structure, the wall thickness, and diameter of vessel 112 not being reduced for neck 116. An elastomeric, chambered stopper-piston 122 is positioned in neck 116 and is in sealing relationship with interior facing wall 124 of neck 116.

[0042] Chambered stopper-piston 122 has a hollow interior chamber 126 and an open distal end 128 with a dislodgeable plug 130 positioned in and sealing said open end 128. Thus, annular edge 132 of plug 130 is tightly fit into annular groove 134 in radially inwardly extending stopper flange 136 of stopper 122. Vessel 112 may be made of glass, plastic or any other material suitable for use consistent with the purpose of the present invention. Stopper-piston 122 may be made of elastomeric plastic or rubber material which will seal well with adjacent surfaces. Plug 130 may be made of PTFE, or any material or combination of materials suitable for sealing with stopper-piston 122. Plug 130 may take the form of a sphere, convex disc, or other forms, and may be used for agitation of the chemicals to be mixed. Stopper piston 122 may have annular ribs 138 or other aids for sealing and stability. With respect to the embodiment shown in FIG. 9A, the plug 130 optionally may be made any material or combination of materials suitable for resisting penetration of the harpoon-plunger 146. For instance, the embodiment shown in FIG. 9A may include a plug 130 that may have an elastomeric body and edge, with a PTFE strike plate 131 attached to the harpoon side to prevent harpoon penetration.

[0043] As shown in FIGS. 8, 9A, and 9B, open distal end 118 of vessel 112 is sealed by rubber sealing cap 133 which is held in place by metal clip 140.

[0044] Referring to FIG. 9A, it is intended that, in use, cap 133 will be pierced by needle 142 when medical mixing vial, or cartridge, 110 is placed in syringe 57. Then, pushrod 146 is moved downwardly to first pierce stopper-piston 122 and then dislodge plug 130 as illustrated in FIG. 9A. Chemical reagent 148 such as buffering material in chamber 126 of stopper-piston 122 is thus allowed to mix with solution 150 in chamber 114. The mixture of drugs is then injected into a patient by manipulating pushrod 146 further downwardly, with shoulder 152 of pushrod 146 pushing against stopper-piston 122 to push stopper-piston 122 downwardly to act as a piston, sliding down vessel 112 and hydraulically expelling the liquid therein through needle 142.

[0045] Referring to FIG. 9B, it is intended that, in use, cap 133 will be pierced by needle 142 when medical mixing vial, or cartridge, 110 is placed in syringe 57. Then, blunt pushrod 147 is moved downwardly to first depress and elongate, but not penetrate, the membrane portion 190 of stopper-piston 122 and then dislodge plug 130, as illustrated in FIG. 9B. Chemical reagent 148 such as buffering material in chamber 126 of stopper-piston 122 is thus allowed to mix with solution 150 in chamber 114. The mixture of drugs is then injected into a patient by manipulating pushrod 147 further downwardly, with shoulder 152 of pushrod 147 pushing against stopper-piston 122 to push stopper-piston 122 downwardly to act as a piston, sliding down vessel 112 and hydraulically expelling the liquid therein through needle 142. Relaxation of the downward pressure on pushrod 147 causes a rebound of membrane 190, which causes aspiration of solution 150 back through the needle 142 and flow in the proximal direction.

[0046] Another embodiment is shown in FIG. 10. As shown in FIG. 10, mixing vial 210 is in the general form of a syringe cartridge and has a generally barrel shaped vessel 212 having a hollow interior chamber 214 and neck 216 having distal and proximal open ends, 218 and 220. Neck 216 is a portion of vessel 212 at the distal end thereof and is simply an extension of the vessels tubular structure, as the wall thickness and diameter of vessel 212 are not changed for neck 216. An elastomeric, chambered stopper 222 is positioned in neck 216 and is in sealing relationship with interior facing wall 224 of neck 216. Stopper 222 has a radially outwardly extending annular flange 238 and ribs 239 and 241and is retained in position in neck 216 during storage and transport by friction with vessel 212. During use, retention of stopper 222 in neck 216 is insured by proximally facing face 260 of syringe 57.

[0047] Chambered stopper 222 has a hollow interior chamber 226 and an open proximal end 228 with a dislodgeable plug 230 positioned in and sealing said open end 228. Thus, annular edge 232 of plug 230 is tightly fit into annular groove 234 in radially inwardly extending stopper flange 236 of stopper 222. The proximal face of stopper flange 236 may have radial grooves 237 to provide flow should plug 230 become lodged against proximal face of flange 236 after dislodgement from groove 234.

[0048] Vessel 212 may be made of glass, plastic or any other material suitable for use consistent with the purpose of the present invention. Stopper 222 may be made of an elastomeric plastic or rubber material, including the typical vial stopper material in present use, which will seal well with adjacent surfaces. Plug 230 may be made of PTFE, or any material or combination of materials suitable for sealing with stopper 222 and resisting penetration of the needle. For instance, plug 230 may have an elastomeric body and edge, with a PTFE strike plate 233 attached to the needle side to prevent needle penetration. Stopper 222 may have annular ribs or other sealing and retentive aids. Neck 216 may have inwardly facing grooves, ledges, or flanges to aid in sealing and retention of stopper 222.

[0049] Open proximal end 220 of vessel 212 is sealed by piston 252. Piston 252 is shown with a hollow recess 254 in the distal face which adds available volume inside the interior chamber 214 of the mixing vial 210 and prevents damage to the proximal end of needle 142 as piston 252 translates distally.

[0050] In use, it is intended that stopper 222 will be pierced by needle 142, as illustrated in FIG. 10 when mixing vial, or cartridge, 210 is placed in syringe 144. Then, needle 142 dislodges plug 230 from stopper 222, as proximally facing syringe face 260 abuts stopper distal face 240 and prevents hydraulic dislodgement. Chemical reagent 248 such as buffering material in chamber 226 of stopper 222 is thus allowed to mix with solution 250 such as local anesthetic in chamber 214. The mixture is then injected into a patient by manipulating syringe pushrod 146 distally against piston 252, hydraulically expelling the liquid through needle 142.

[0051] While embodiments of the present invention have been disclosed, it will be appreciated by those skilled in the art that the invention is subject to variations and modifications and it is intended that the invention will be limited only by the following claims. For example, as alternatives to the embodiments disclosed, the vial may be of three or more chambers instead of two, allowing the mixing of more components. The vial may serve to enhance the in-situ mixing of chemicals in applications not specifically mentioned here or in applications not yet contemplated. The materials to be mixed in either chamber may be a solid, powdered solid, fluid, gas, or a mixture of any or all of the above. Coloring, clouding, or other reagents may be used to visually indicate mixing of the components or leakage of the seals between the chambers or the exterior. The plug to be dislodged may be rigid, or mainly rigid with an elastic portion or mainly elastic with a rigid portion. The stopper may be elastic, or mainly elastic with a rigid portion, or mainly rigid with an elastic portion. Any of the parts may include features that improve, simplify, or shorten the manufacturing of those parts or improve, simplify, or shorten the assembling of the overall apparatus. Any of the parts or the overall apparatus may include features that improve the visual marketing appeal of the apparatus. The vessel or any part of the vessel, while described in the embodiments as having a generally circular cross-section in one plane, may have any other shape in cross-section that permits use.