Mixing vial

Abstract

Various implementations include a mixing vial for use in a cartridge syringe. The mixing vial includes a vessel, a stopper, and a dislodgeable plug. The inner surface of the vessel defines a vessel interior chamber. The stopper includes a side wall having an open first end and a closed second end. The stopper defines a stopper interior chamber with an inner surface defining an annular stopper groove. The dislodgeable plug is disposed within the stopper interior chamber such that an edge of the plug is disposed within the annular stopper groove and is dislodgeable from the open first end of the stopper. One of the inner surface of the vessel or the outer surface of the stopper defines an engagement groove, and an engagement protrusion extends radially away from the other. The engagement protrusion is disposable within the engagement groove when the stopper is disposed within the vessel interior chamber.

Description

Attorney Docket No. 11014-007W01MIXING VIALCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U. S. Provisional Application No.63 / 760,317, filed February 19, 2025, which is expressly incorporated herein by reference in its entirety.BACKGROUND

[0002] For various reasons, some drugs must be stored and transported in two parts, and then mixed together just prior to administration. For example, steroid drugs in powder form are sometimes mixed with various vehicles just prior to injection and local anesthetics are sometimes mixed with NaHCO3 buffering solution just prior to injection.

[0003] In addition, some drugs require agitation immediately prior to injection, and therefore require headspace for effective agitation, while at the same time being susceptible to oxidative degradation which occurs during storage from the gas in the headspace. These drugs benefit from vials that eliminate headspace during storage, but allow head space for agitation just prior to injection.

[0004] Local anesthetic solution exerts its effect by blocking transmission of the nerve signal in the area of the nerve where the solution has been deposited. Generally speaking anesthetic solutions must be acidified to an acid pH of about 4.0 (akin to vinegar) to obtain adequate shelflife. This acid solution is painful to the patient when injected, and is just one more reason that people don’t like getting shots at the dentists’ or physicians’ office. In addition, the drug does not exert any effect at this low “storage” pH, so the patient must wait several minutes after injection before the numbness begins, while their body slowly brings the pH up to that of the body tissues, which is about 7.4.

[0005] Overwhelming evidence demonstrates that raising the pH of the anesthetic to a pH closer to neutral just prior to injection (“buffering”) greatly decreases the pain associated with injection, as well as the latency of the anesthetic effect. Because of this, many inventors over several decades have attempted to help make buffering a widespread practice in both dentistry and medicine, but at present no method has been satisfactory for a number of reasons.Attorney Docket No. 11014-007W01

[0006] Sodium bicarbonate (NaIICO3) in an 8.4% aqueous solution is the most common solution used to buffer anesthetic. The NaHCO3 solution and the local anesthetic solution are typically mixed in a ratio of about 9 parts anesthetic to 1 part NaHCO3 solution.

[0007] When physicians, such as dermatologists and plastic surgeons, buffer their anesthetic, they first draw anesthetic solution into their syringe from a vial, and then add NaHCO3 solution to the syringe by drawing it from a separate vial. The unused anesthetic and NaHCO3 solutions, in their respective vials, along with the needle and syringe, must be discarded after each patient. This protocol typically wastes more than 90% of the NaHCO3, and two vials are required. In addition, the mixing protocol is subject to human error and has resulted in protocol breaches, including improper drug ratios, sterility breaches, and intentional “re-use” of single-patient drug vials on other patients, with resulting adverse medical outcomes. This method is also somewhat cumbersome, time-consuming, and uneconomical. However, despite the risk and the cost in time and money, many physicians buffer their anesthetic, as it makes a significant difference in the patient’s comfort when performed properly.

[0008] It would be preferable to have a system for the physician to draw and mix anesthetic medications using only one vial. Drawing from one vial instead of two would save valuable time, make the process safer, save the costs of the extra vial and the excess buffer solution, result in more widespread use of buffering, and increase patient comfort.

[0009] In the oral environment, because of the special need for dexterity and the likelihood of multiple injections on the same patient, dentists typically inject the anesthetic solution with a reusable hand-held metal syringe, which has evolved and consolidated into a single design that accounts for almost all syringes in use in dentistry and oral surgery. This syringe is used in conjunction with a disposable hollow injection needle which is attached to the syringe and a specialized glass drug vial called a “cartridge” or “carpule” of anesthetic solution, which is placed into the syringe. As the cartridge is placed into the syringe, the cartridge is pierced by the back end of the needle, so that solution can flow out and through the needle. The cartridge has a piston that is driven by a pushrod on the syringe, so that when the dentist pushes on the pushrod the piston drives the solution through the attached needle.

[0010] The cartridge has the shape of an elongated ban-el. The cartridge is sealed on one end with a puck shaped elastomeric membrane that is fastened with a crimped metal cap in the manner typical of most glass drug vials A notable and important difference between a dental cartridge and a typical drug vial is the size. A dental cartridge volume is typically lessAttorney Docket No. 11014-007W01than 2 ml, due mainly to limitations imposed by the syringe fitting in the operator’s hand and its use in the mouth, whereas a typical drug vial has a volume of 10 - 100 ml.

[0011] Dentists who buffer their anesthetic typically use one of two commercially available systems. Both of these systems add considerable time and expense to the procedure. The ongoing product cost per injection of the commercially available systems is many times that of an unbuffered protocol. One system for dentists requires dentists to use a syringe / needle combination that is very different than the standard system that is ubiquitous in the industry. This system also requires a countertop device that contains both anesthetic solution and NaHC03 solution in separate vials and is used to load the disposable syringe / needle combination. This is time consuming, expensive, and its use is subject to operator error and breaches of sterile and pharmacological protocol.

[0012] Another system for dentists utilizes an injector that introduces NaHCO3 into the standard dental cartridge. This system requires that each cartridge be separately loaded with NaHCO3, which is time consuming, and in some states legally prohibited except by licensed pharmacists. In addition, this system causes a significant loss of available drug volume in the cartridge as well as being subject to operator error and breaches of sterile and pharmacological protocol.

[0013] In spite of their disadvantages, both systems have found a limited market, demonstrating that buffering is very desirable from both a dentist’s and a dental patient’s perspective. Making the buffering process less time consuming, less expensive, safer, and more similar to current surgical protocol would result in more widespread use for the benefit of both patient and dentist.

[0014] In the case of steroid drugs, physicians typically are provided with a special glass vial that has been partitioned into two chambers. The glass vial is provided with a plunger mechanism that the physician manually depresses to mix the contents of the chambers. The “Act-0- Vial” is typical of these special vials. The Act-0- Vial consists of seven parts and requires a specially shaped glass vial and apparatus.

[0015] The Act-0-Vial and similar special vials are also used in conjunction with drugs which require headspace for agitation, but benefit from a lack of headspace during storage. In this case, the fluid in the first chamber is stored without headspace, and then utilizes the headspace in the second chamber to permit agitation.

[0016] There remains a need to provide a less time consuming and less expensive method for in situ mixing or agitation of drugs, notably including the buffering of localAttorney Docket No. 11014-007W01anesthetic and the mixing of steroids for injection. Accordingly it is desired to provide various embodiments of the present invention as follows: to provide a mixing cartridge suited for use with dental syringes which may be manufactured more simply, using an extruded hollow glass tube that is cut to length, rather than a complicated form requiring each cartridge to be individually blown around a mandrel; to simplify the filling and sealing of the dental cartridge by requiring fewer and simpler parts; to eliminate the use of metal crimped caps for sealing, along with the metal dirt and dust which contaminates the clean or sterile assembly lines required for the manufacture of dental cartridges; to provide maximal interior volume to contain a drug; to facilitate the ability to eliminate gaseous headspace and the associated oxidative degradation of the drug in a dental cartridge; to provide a mixing dental cartridge that allows maximum interior volume for drug storage while minimizing breakage; to provide mixing or agitation of drugs used in medicine or dentistry using a minimum of simple parts; to reduce the possibility of operator error and breaches in sterile or pharmacological protocol when mixing drugs; to provide a mixing vial stopper which may be used with the typical medical vial and the typical crimped sealing cap, rather than requiring a specially shaped vial that is difficult to manufacture or a multipart sealing mechanism; to save time and cost, to facilitate accurate proportioning of materials to be mixed and avoid operator error; to make widespread the use of local anesthetic buffering; to reduce pain and waiting time in the administration of local anesthesia in medical and dental offices.

[0017] Other advantages of one or more aspects will be apparent from the following disclosure and claims taken in conjunction with the accompanying drawings.SUMMARY

[0018] Various implementations include a mixing vial for use in a cartridge syringe. The mixing vial includes a vessel, a stopper, and a dislodgeable plug. The vessel has a proximal end, a distal end opposite and spaced apart from the proximal end, and an inner surface extending from the proximal end to the distal end. The inner surface defines a vessel interior chamber extending from the distal end toward the proximal end. The stopper includes a side wall having an open first end, a closed second end opposite and spaced apart from the open first end, an outer surface extending between the open first end and the closed second end, and an inner surface radially spaced apart from the outer surface of the stopper. The inner surface and the closed second end of the stopper define a stopper interior chamber. The inner surface of the stopper defines an annular stopper groove. The dislodgeable plug isAttorney Docket No. 11014-007W01disposed within the stopper interior chamber such that at least a portion of an edge of the dislodgeable plug is disposed within the annular stopper groove. The entire dislodgeable plug is fully dislodgeable as a single piece from the open first end of the stopper. One of the inner surface of the vessel or the outer surface of the stopper defines an engagement groove. An engagement protrusion extends radially away from an other of the outer surface of the stopper or the inner surface of the vessel. The engagement protrusion is disposable within the engagement groove when the stopper is disposed within the vessel interior chamber and is in a sealing relationship with a portion of the inner surface of the vessel.

[0019] In some implementations, the closed second end of the stopper includes a radially outwardly extending annular flange. In some implementations, the engagement protrusion is disposable within the engagement groove when the radially outwardly- extending annular flange abuts the distal end of the vessel.

[0020] In some implementations, the distal end of the vessel is spaced apart from either the engagement groove defined by the inner surface of the vessel or engagement protrusion extending radially away from the inner surface of the vessel by a distance. In some implementations, the distance is 2 mm or less. In some implementations, the distance is 1 mm or less.

[0021] In some implementations, the engagement groove extends circumferentially at least partially around the one of the inner surface of the vessel or the outer surface of the stopper. In some implementations, the engagement groove fully extends circumferentially around the one of the inner surface of the vessel or the outer surface of the stopper to form an annular engagement groove.

[0022] In some implementations, the engagement protrusion extends circumferentially at least partially around the other of the outer surface of the stopper or the inner surface of the vessel. In some implementations, the engagement protrusion fully extends circumferentially around the other of the outer surface of the stopper or the inner surface of the vessel to form an annular engagement protrusion.

[0023] In some implementations, the inner surface of the vessel defines the engagement groove and the engagement protrusion extends radially away from the outer surface of the stopper.

[0024] In some implementations, the outer surface of the stopper defines the engagement groove and the engagement protrusion extends radially away from inner surface of the vessel.Attorney Docket No. 11014-007W01

[0025] In some implementations, the outer surface of the stopper includes two or more ribs extending radially outwardly from the outer surface of the stopper. In some implementations, each of the two or more ribs are axially spaced apart from each other. In some implementations, the two or more ribs form a sealing relationship with a portion of the inner surface of the vessel when the stopper is disposed within the vessel interior chamber. In some implementations, the two or more ribs includes three or more ribs.

[0026] In some implementations, the mixing vial further includes a piston slidably positioned within the vessel interior chamber. In some implementations, the piston defines a hollow recess in a distal face.

[0027] In some implementations, the closed second end of the stopper and the side wall are formed as a single piece.

[0028] In some implementations, the vessel has an interior diameter as measured from the inner surface of the vessel across the vessel interior chamber. In some implementations, the interior diameter is uniform from the engagement groove or engagement protrusion to the proximal end of the vessel. In some implementations, the interior diameter is uniform from the engagement groove or engagement protrusion to the distal end of the vessel.

[0029] In some implementations, the inner surface of the stopper includes a radially inwardly extending flange. In some implementations, the flange defines the annular stopper groove.

[0030] In some implementations, an anesthetic is disposed within the vessel interior chamber. In some implementations, a buffering reagent is disposed within the stopper interior chamber.

[0031] In some implementations, the cartridge syringe comprises a dental syringe. In some implementations, the vessel includes a shape that allows use with the dental syringe.

[0032] In some implementations, the stopper comprises an elastomeric plastic or rubber.

[0033] In some implementations, the cartridge syringe includes a needle. In some implementations, the needle pierces the closed second end of the stopper and dislodges the dislodgeable plug when the mixing vial is loaded into or disposed in the cartridge syringe.

[0034] Various other implementations include a syringe system. The system includes a syringe and a mixing vial as disclosed herein. The syringe includes a body, a syringe needle, and an axially movable plunger. The body has a distal end. The syringe needle has aAttorney Docket No. 11014-007W01distal end and a proximal end. The syringe needle is statically coupled to the distal end of the body. When the mixing vial is loaded into or disposed in 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.

[0035] In some implementations, the syringe includes a dental syringe. In some implementations, the vessel includes a shape that allows use with the dental syringe.

[0036] In some implementations, the syringe needle pierces the stopper and dislodges the dislodgeable plug when the mixing vial is loaded into or disposed in the cartridge syringe.DESCRIPTION OF DRAWINGS

[0037] FIG. 1 is a side elevation of a conventional needle / syringe apparatus for use in combination with a vial of the present invention.

[0038] FIG. 2 is a perspective view of a conventional vial having a single chamber.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] FIG. 6 is an exploded sectional view, broken away, of the conventional dental cartridge needle / syringe apparatus of FIG. 5.

[0043] FIG. 7 is a perspective view of a conventional dental cartridge having a single chamber.

[0044] 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.

[0045] 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.

[0046] 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.Attorney Docket No. 11014-007W01

[0047] 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.

[0048] FIG. 11 A is a sectional view of a disassembled mixing vial according to another implementation.

[0049] FIG. 1 IB is a sectional view of the mixing vial of FIG. 11 A with the stopper disposed within the vessel.

[0050] FIG. 12A is an end view of the vessel of the mixing vial of FIG. 11 A.

[0051] FIG. 12B is a side view of the vessel of the mixing vial of FIG. HA with partial cutaway sectional view's.

[0052] FIG. 12C is a detail sectional view of the proximal end of the vessel of the mixing vial of FIG. HA.

[0053] FIG. 12D is a detail view of the distal end of the vessel of the mixing vial of FIG. HA with partial cutaway sectional views.

[0054] FIG. 13A is a side view of the stopper of the mixing vial of FIG. 11A with partial cutaway sectional view's.

[0055] FIG. 13B is a second end view of the stopper of the mixing vial of FIG. 11 A.

[0056] FIG. 13C is a first end view of the stopper of the mixing vial of FIG. 11 A.DETAILED DESCRIPTION

[0057] 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.

[0058] 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.

[0059] 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.Attorney Docket No. 11014-007W01An elastomeric, chambered stopper 22 is positioned in neck 16 and is in sealing relationship with interior facing wall 24 of neck 16.

[0060] 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.

[0061] 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 1 attached to the needle side to prevent needle penetration.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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 withdrawsAttorney Docket No. 11014-007W01the mixed drug solution from the inverted vial into the syringe apparatus and administers it to the patient in the typical manner.

[0066] 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.

[0067] 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 12.0. 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.

[0068] 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. 9 A, 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. 9 A 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.

[0069] 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.

[0070] 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 plugAttorney Docket No. 11014-007W01130 as illustrated in FIG. 9A. Chemical reagent 148 such as buffering material in chamber 12.6 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 apiston, sliding down vessel 112 and hydraulically expelling the liquid therein through needle 142.

[0071] Referring to FIG. SIB, 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.

[0072] 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 241 and 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.

[0073] 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 mayAttorney Docket No. 11014-007W01have radial grooves 237 to provide flow should plug 230 become lodged against proximal face of flange 236 after dislodgement from groove 234.

[0074] 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 PI’FE, 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.

[0075] 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.

[0076] 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.

[0077] FIGS. 11A-13C show a mixing vial 310 having aspects according to various implementations. The mixing vial 310 shown in FIGS. 11A-13C is similar to those shown in FIGS. 1-10, and it is contemplated that features of the mixing vials 10, 110, 210 shown in FIGS. 1-10 can be incorporated in addition to, in combination with, and / or in replacement of one or more features of the mixing vial 310 shown in FIGS. 11A-13C to form various other implementations according to the disclosure herein.

[0078] The mixing vial 310 for use in a cartridge syringe 57 shown in FIGS. 11A-13C includes a vessel 312, a stopper 322, and a dislodgeable plug 330.

[0079] The vessel 12 has a proximal end 320 and a distal end 318 opposite and spaced apart from the proximal end 320. The vessel 312 also has an inner surface 324Attorney Docket No. 11014-007W01extending from the proximal end 320 of the vessel 312 to the distal end 318 of the vessel 312 that defines a vessel interior chamber 314 extending from the distal end 318 toward the proximal end 320. The proximal end 320 and the distal end 318 of the vessel 312 have rounded edges to allow for easier insertion of a stopper 322 and / or a piston 252 during assembly. The vessel interior chamber 314 shown in FIGS. 11A-12D extends from the distal end 318 of the vessel 312 to the proximal end 320 of the vessel 312 to form a hollow tube, but in some implementations, the vessel interior chamber only extends partially from the distal end toward the proximal end such that the proximal end is a closed end.

[0080] The inner surface 324 of the vessel 312 defines an engagement groove 315 adjacent the distal end 318 of the vessel 312. For the vessel 312 shown in FIGS. 11A-12D, the distal end 318 of the vessel 312 is spaced apart from the engagement groove 315 by a distance of 1 mm. However, in some implementations, the distal end of the vessel is spaced apart from the engagement groove by a distance in the range of 4 mm or less, such as 3.75 mm or less, 3.5 mm or less, 3.25 mm or less, 3.0 mm or less, 2.75 mm or less, 2.5 mm or less, 2.25 mm or less, 2.0 mm or less, 1.75 mm or less, 1.5 mm or less, 1.25 mm or less, 1.0 mm or less, 0.75 mm or less, 0.5 mm or less, or 0.25 mm or less.

[0081] The engagement groove 315 shown in FIGS. 11 A-12D fully extends circumferentially around the inner surface 324 of the vessel 312 to form an annular engagement groove 315. However, in some implementations, the engagement groove extends circumferentially at least partially around the inner surface of the vessel.

[0082] The vessel 312 has an interior diameter as measured from the inner surface 324 of the vessel 312 across the vessel interior chamber 314. The interior diameter is uniform from the engagement groove 315 to the proximal end 320 of the vessel 312 and from the engagement groove 315 to the distal end 318 of the vessel 312. Although the interior diameter from the engagement groove 315 to the proximal end 320 of the vessel 312 and the interior diameter from the engagement groove 315 to the distal end 318 of the vessel 312 in FIGS. 11A-12D are equal, in some implementations, the interior diameter from the engagement groove to the proximal end of the vessel is a uniform first diameter and the interior diameter from the engagement groove to the distal end of the vessel is a uniform second diameter that is different from the first diameter. In some implementations, the interior diameter from the engagement groove to the proximal end of the vessel is nonuniform and / or the interior diameter from the engagement groove to the distal end of the vessel is nonuniform.Attorney Docket No. 11014-007W01

[0083] The stopper 322 includes a side wall 323 having an open first end 328 and a closed second end 340 opposite and spaced apart from the open first end 328. The stopper 322 further has an outer surface 327 extending between the open first end 328 and the closed second end 340 and an inner surface 329 radially spaced apart from the outer surface 327 of the stopper 322. The inner surface 329 and the closed second end 340 of the stopper 322 define a stopper interior chamber 326. The outer surface 327 of the stopper 322 at the open first end 328 defines a taper 337 to allow for easier insertion of the stopper 322 into the vessel interior chamber 314 during assembly.

[0084] The stopper 322 shown in FIGS. 11A, 11B, and 13A-13C includes an elastomeric plastic or rubber, but in some implementations, the stopper includes any resilient material capable of being penetrated by a needle. The closed second end 340 of the stopper 322 and the side wall 323 shown in FIGS. 11A and 13A-13C are formed as a single piece. However, in some implementations, the closed second end of the stopper and the side wall are formed separately and coupled to each other by known means.

[0085] The inner surface 329 of the stopper 322 includes a radially inwardly extending flange 336 adjacent the open first end 328. The radially inwardly extending flange 336 has a first flange portion 333 and a second flange portion 335 axially spaced apart from the first flange portion 333. The first flange portion 333 is axially closer than the second flange portion 335 to the open first end 328 of the stopper 322. The first flange portion 333 and the second flange portion 335 of the radially inwardly extending flange 336 of the inner surface 329 of the stopper 322 defines an annular stopper groove 334 for receiving the edge 332 of the dislodgeable plug 330, as discussed below. The radially inwardmost edge of the first flange portion 333 has a first diameter, and the radially inwardmost edge of the second flange portion 335 has a second diameter. The first diameter is larger than the second diameter.

[0086] The different diameter flange portions 333, 335 that define the inward facing annular stopper groove 334 allow for easier insertion of a dislodgeable plug 330 into the annular stopper groove 334 without over inserting the dislodgeable plug 330 into the stopper interior chamber 326. When the annular stopper groove is simply defined by the side wall of the stopper, the plug must exert compressive forces on the end of the side wall of the stopper to deform the side wall enough to allow the plug to be inserted into the groove.

[0087] For an annular' stopper groove defined by a flange that extends radially inwardly from the side wall of the stopper, the plug exerts shear and tensile forces on theAttorney Docket No. 11014-007W01cantilevered flanges, which requires less force from the user during insertion. While this makes it easier for insertion into the annular stopper groove, it can also make it easier to over-insert the plug past the groove and into the stopper interior chamber. Inclusion of a second flange portion that has a smaller diameter minimizes the chances of the user overexerting the plug past the annular stopper groove and into the stopper interior chamber.

[0088] Although the stopper 322 shown in FIGS. 11A, 11B, and 13A-13C includes a radially inwardly extending flange 336, in some implementations, the stopper does not include a radially inwardly extending flange and the inner surface of the stopper defines an annular stopper groove.

[0089] The outer surface 327 of the stopper 322 includes two ribs 339, 341 extending radially outwardly from the outer surface 327 of the stopper 322. Each of the two ribs 339, 341 are axially spaced apart from each other. The two ribs 339, 341 are configured to form a sealing relationship with a portion of the inner surface 324 of the vessel 312 when the stopper 322 is disposed within the vessel interior chamber 314 to prevent leaking of the contents of the mixing vial 310 and to prevent axial movement of the stopper 322 when disposed within the vessel 312. Although the outer surface 327 of the stopper 322 shown in FIGS. 11A and 13A-13C includes two ribs 339, 341, in some implementations, the stopper includes any number of one or more ribs, such as two or more ribs, three or more ribs, four or more ribs, five or more ribs, six or more ribs, seven or more ribs, eight or more ribs, nine or more ribs, or ten or more ribs.

[0090] The stopper 322 further includes an engagement protrusion 325 extending radially away from the outer surface 327 of the stopper 322. The engagement protrusion 325 is disposable within the engagement groove 315 when the stopper 322 is disposed within the vessel interior chamber 314 and is in a sealing relationship with a portion of the inner surface 324 of the vessel 312. The closed second end 340 of the stopper 322 further includes a radially outwardly extending annular flange 338 that is configured to abuts the distal end 318 of the vessel 312 when the engagement protrusion 325 is disposed within the engagement groove 315. The engagement of the engagement protrusion 325 with the engagement groove 315 secures the stopper 322 within the distal end 318 of the vessel interior chamber 314 during operation.

[0091] The engagement protrusion 325 shown in FIGS. 11A and 13A-13C is spaced apart from the radially outwardly extending annular flange 338 by a distance of 1.0 mm to match the distance from the distal end 318 of the vessel 312 to the engagement groove 315.Attorney Docket No. 11014-007W01However, in some implementations, the engagement protrusion is spaced apart from the radially outwardly extending annular flange by a distance in the range of 4 mm or less, such as 3.75 mm or less, 3.5 mm or less, 3.25 mm or less, 3.0 mm or less, 2.75 mm or less, 2.5 mm or less, 2.25 mm or less, 2.0 mm or less, 1.75 mm or less, 1.5 mm or less, 1.25 mm or less, 1.0 mm or less, 0.75 mm or less, 0.5 mm or less, or 0.25 mm or less.

[0092] The engagement protrusion 325 shown in FIGS. 11A, 11B, and 13A-13C fully extends circumferentially around the outer surface 327 of the stopper 322 to form an annular engagement protrusion 325. However, in some implementations, the engagement protrusion extends circumferentially at least partially around the outer surface of the stopper. In some implementations, the engagement groove fully extends circumferentially around the inner surface of the vessel and the engagement protrusion extends circumferentially at least partially around the outer surface of the stopper. In such implementations, the engagement protrusion can still be disposed within the annular engagement groove, but the user does not have to “clock,” or angularly orient, the engagement protrusion with the engagement groove since the engagement groove extends circumferentially around the inner surface of the vessel.

[0093] The inner surface 324 of the vessel 312 shown in FIGS. 11-13C defines the engagement groove 315 and the engagement protrusion 325 extends radially away from the outer surface 327 of the stopper 322, however, in some implementations, the outer surface of the stopper defines the engagement groove and the engagement protrusion extends radially away from inner surface of the vessel such that the engagement protrusion is disposable within the engagement groove when the stopper is disposed within the vessel interior chamber and is in a sealing relationship with a portion of the inner surface of the vessel. In such implementations, the dimensions, locations, and uses of the engagement groove and the engagement protrusion can be the same as those described above with respect to the implementation shown in FIGS. 11-13C.

[0094] FIGS. 11A and 11B shows the dislodgeable plug 330 disposed within the stopper interior chamber 326 such that at least a portion of an edge 332 of the dislodgeable plug 330 is disposed within the annular stopper groove 334. The entire dislodgeable plug 330 is fully dislodgeable as a single piece from the open first end 328 of the stopper 322.

[0095] In FIGS. 11 A and 1 IB, an anesthetic 350 is disposed within the vessel interior chamber 314, and a buffering material 348 is disposed within the stopper interior chamber 326. The dislodgeable plug 330 separates the anesthetic 350 from the buffering material 348.Attorney Docket No. 11014-007W01As in the implementation shown in FIG. 10, the mixing vial 312 shown in FIGS. 11 A-12D can further include a piston 252 slidably positioned within the vessel interior chamber 314. Similar to the piston 252 shown in FIG. 10, the piston 252 can define a hollow' recess 254 in a distal face to allow for the dislodgeable plug 330 to enter the recess 254 once dislodged from the stopper 322.

[0096] The mixing vial 310 can be used with a cartridge syringe 57 such as the dental syringe shown in FIGS. 5 and 6. As described in detail above, such a syringe 57 includes a body 58 having a distal end 60, a syringe needle 142, and an axially movable plunger 146. The syringe needle 142 has a distal end 143 and a proximal end 144, and the syringe needle 142 is statically coupled to the distal end 60 of the body 58 of the syringe 57. When the mixing vial 310 is loaded into or disposed in the syringe 57, the proximal end 144 of the syringe needle 142 is able to penetrate the closed second end 340 of the stopper 322. The proximal end 144 of the needle 142 passes through the stopper interior chamber 326 and contacts the dislodgeable plug 330, which fully dislodges the dislodgeable plug 330 from the stopper 322. The anesthetic 350 disposed within the vessel interior chamber 314 and the buffering material 348 disposed within the stopper interior chamber 326 are then able to mix.

[0097] A number of example implementations are provided herein. However, it is understood that various modifications can be made without departing from the spirit and scope of the disclosure herein. As used in the specification, and in the appended claims, the singular forms “a,” “an,” “the” include plural referents unless the context clearly dictates otherwise. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. Although the terms “comprising” and “including” have been used herein to describe various implementations, the terms “consisting essentially of’ and “consisting of’ can be used in place of “comprising” and “including” to provide for more specific implementations and are also disclosed.

[0098] Disclosed are materials, systems, devices, methods, compositions, and components that can be used for, can be used in conjunction with, can be used in preparation for, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed that while specific reference of each various individual and collective combinations and permutations of these components may not be explicitly disclosed, each is specifically contemplated and described herein. ForAttorney Docket No. 11014-007W01example, if a device is disclosed and discussed each and every combination and permutation of the device are disclosed herein, and the modifications that are possible are specifically contemplated unless specifically indicated to the contrary. Likewise, any subset or combination of these is also specifically contemplated and disclosed. This concept applies to all aspects of this disclosure including, but not limited to, steps in methods using the disclosed systems or devices. Thus, if there are a variety of additional steps that can be performed, it is understood that each of these additional steps can be performed with any specific method steps or combination of method steps of the disclosed methods, and that each such combination or subset of combinations is specifically contemplated and should be considered disclosed.

Claims

Attorney Docket No. 11014-007W01WHAT IS CLAIMED IS:

1. A mixing vial for use in a cartridge syringe, the mixing vial comprising:a vessel having a proximal end, a distal end opposite and spaced apart from the proximal end, and an inner surface extending from the proximal end to the distal end, wherein the inner surface defines a vessel interior chamber extending from the distal end toward the proximal end;a stopper including a side wall having an open first end, a closed second end opposite and spaced apart from the open first end, an outer surface extending between the open first end and the closed second end, and an inner surface radially spaced apart from the outer surface of the stopper, wherein the inner surface and the closed second end of the stopper define a stopper interior chamber, wherein the inner surface of the stopper defines an annular stopper groove; anda dislodgeable plug disposed within the stopper interior chamber such that at least a portion of an edge of the dislodgeable plug is disposed within the annular stopper groove, wherein the entire dislodgeable plug is fully dislodgeable as a single piece from the open first end of the stopper,wherein one of the inner surface of the vessel or the outer surface of the stopper defines an engagement groove,wherein an engagement protrusion extends radially away from an other of the outer surface of the stopper or the inner surface of the vessel, andwherein the engagement protrusion is disposable within the engagement groove when the stopper is disposed within the vessel interior chamber and is in a sealing relationship with a portion of the inner surface of the vessel.

2. The mixing vial of claim 1, wherein the closed second end of the stopper includes a radially outwardly extending annular flange.

3. The mixing vial of claim 2, wherein the engagement protrusion is disposable within the engagement groove when the radially outwardly extending annular flange abuts the distal end of the vessel.Attorney Docket No. 11014-007W014. The mixing vial of claim 1, wherein the distal end of the vessel is spaced apart from either the engagement groove defined by the inner surface of the vessel or engagement protrusion extending radially away from the inner surface of the vessel by a distance, wherein the distance is 2 mm or less.

5. The mixing vial of claim 4, wherein the distance is 1 mm or less.

6. The mixing vial of claim 1, wherein the engagement groove extends circumferentially at least partially around the one of the inner surface of the vessel or the outer surface of the stopper.

7. The mixing vial of claim 6, wherein the engagement groove fully extends circumferentially around the one of the inner surface of the vessel or the outer surface of the stopper to form an annular engagement groove.

8. The mixing vial of claim 1, wherein the engagement protrusion extends circumferentially at least partially around the other of the outer surface of the stopper or the inner surface of the vessel.

9. The mixing vial of claim 8, wherein the engagement protrusion fully extends circumferentially around the other of the outer surface of the stopper or the inner surface of the vessel to form an annular engagement protrusion.

10. The mixing vial of claim 1, wherein the inner surface of the vessel defines the engagement groove and the engagement protrusion extends radially away from the outer surface of the stopper.

11. The mixing vial of claim 1, wherein the outer surface of the stopper defines the engagement groove and the engagement protrusion extends radially away from inner surface of the vessel.

12. The mixing vial of claim 1, wherein the outer surface of the stopper includes two or more ribs extending radially outwardly from the outer surface of the stopper, wherein each ofAttorney Docket No. 11014-007W01the two or more ribs are axially spaced apart from each other, wherein the two or more ribs form a sealing relationship with a portion of the inner surface of the vessel when the stopper is disposed within the vessel interior chamber.

13. The mixing vial of claim 12, wherein the two or more ribs comprises three or more ribs.

14. The mixing vial of claim 1, further comprising a piston slidably positioned within the vessel interior chamber.

15. The mixing vial of claim 14, wherein the piston defines a hollow recess in a distal face.

16. The mixing vial of claim 1, wherein the closed second end of the stopper and the side wall are formed as a single piece.

17. The mixing vial of claim 1, wherein the vessel has an interior diameter as measured from the inner surface of the vessel across the vessel interior chamber, wherein the interior diameter is uniform from the engagement groove or engagement protrusion to the proximal end of the vessel.

18. The mixing vial of claim 17, wherein the interior diameter is uniform from the engagement groove or engagement protrusion to the distal end of the vessel.

19. The mixing vial of claim 1, wherein the inner surface of the stopper includes a radially inwardly extending flange, wherein the flange defines the annular stopper groove.

20. The mixing vial of claim 1, wherein an anesthetic is disposed within the vessel interior chamber, and a buffering material is disposed within the stopper interior chamber.

21. The mixing vial of claim 1, wherein the cartridge syringe comprises a dental syringe, the vessel comprising a shape that allows use with the dental syringe.Attorney Docket No. 11014-007W0122. The mixing vial of claim 1, wherein the stopper comprises an elastomeric plastic or rubber.

23. The mixing vial of claim 1, wherein the cartridge syringe comprises a needle, wherein the needle pierces the closed second end of the stopper and dislodges the dislodgeable plug when the mixing vial is loaded into or disposed in the cartridge syringe.

24. A syringe system, the system comprising:a syringe comprising:a body having a distal end,a syringe needle having a distal end and a proximal end, wherein the syringe needle is statically coupled to the distal end of the body, andan axially movable plunger; andthe mixing vial of claim 1,wherein, when the mixing vial is loaded into or disposed in 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.

25. The system of claim 24, wherein the syringe comprises a dental syringe, the vessel comprising a shape that allows use with the dental syringe.

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

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