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Title:
METHOD AND APPARATUS FOR APPLYING AN ANESTHETIC AND BACTERICIDE
Document Type and Number:
WIPO Patent Application WO/2016/164817
Kind Code:
A1
Abstract:
A method and an apparatus for applying an anesthetic includes a receptacle having an upper end, a substantially hollow interior, a lower end having a tube or nozzle extending therefrom, and an attachment for attaching to the barrel of a syringe or vice versa. The receptacle receives a container or canister containing an endothermic gas or vapor(propellant) that rapidly absorbs heat when released to the atmosphere. A depressible actuating member or trigger propels the gas or vapor through an outlet nozzle that is oriented to project a stream of gas or vapor along a delivery axis that intersects a delivery axis of the needle, therefore, the gas or vapor can be successively delivered to an injection site with minimal repositioning of the housing.

Inventors:
LEIBOVICI JACOB (US)
Application Number:
PCT/US2016/026775
Publication Date:
October 13, 2016
Filing Date:
April 08, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
LEIBOVICI JACOB (US)
International Classes:
A61M5/20; A61M5/24; A61M5/31; A61M5/42
Domestic Patent References:
WO2008005315A22008-01-10
Foreign References:
US3605742A1971-09-20
EP2641629A12013-09-25
US20150094661A12015-04-02
US20090326478A12009-12-31
US20110098634A12011-04-28
Other References:
None
Attorney, Agent or Firm:
CAMPBELL, Keith A. et al. (P.A.2855 PGA Boulevar, Palm Beach Gardens FL, US)
Download PDF:
Claims:
CLAIMS

What is claimed is:

Claim 1. An autoinjector syringe and endothermic gas anesthetic assembly comprising:

a module which is removably attached to anautoinjector syringe barrel and which accommodates a canister having a pressurized gaseous anesthetizing composition, said module includes an elongated outlet nozzle 20 for directing said gaseous anesthetizing composition to intersect with adelivery axis 30 of a needle connected to said autoinjector syringe.

Claim 2. The autoinjector syringe and endothermic gas anesthetic assembly of claim 1 wherein said module includes an adjunct chamber frame, said adjunct chamber frame including attachment means for securing said adjunct chamber frame to said autoinjector syringe, an outlet nozzle for said gaseous anesthetizing composition, and a dispenser cap for dispensing said gaseous anesthetizing composition, said canister slidably secured within said adjunct chamber frame, said canister including a dispensing tube in mechanical cooperation with said dispenser cap so that sliding said canister within said adjunct chamber frame causes said gaseous anesthetizing composition to be directed from said canister through said outlet nozzle.

Claim 3. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said attachment means is a securable clip, said securable clip includes a pair of arcuate members, so that said arcuate members may be closed around an outer diameter of the autoinjector syringe and latched in place.

Claim 4. The autoinjector syringe and endothermic gas anesthetic assembly of claim 4 wherein said actuate members of said securable clip are secured together with a pin. Claim 5. The autoinjector syringe and endo thermic gas anesthetic assembly of claim 4 wherein said actuate members of said securable clip are secured together with a rotatable latch.

Claim 6. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said dispenser cap is used to close a distal end of said adjunct chamber frame and to cooperate with a valve assembly of said canister to cause the pressurized gaseous anesthetizing composition to be dispensed.

Claim 7. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said outlet nozzle includes a pocket sized to contain said dispenser cap.

Claim 8. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein saidoutlet nozzle is tubular in construction having a distal end with an opening, said opening including a restrictor for inserted into said opening having a particularly configured passageway, to cause the anesthetic sprayed therefrom to spray in a desired pattern.

Claim 9. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein saidoutlet nozzle is tubular in construction having a distal end with an opening, said opening including a venturi for insertion into said opening having a particularly configured passageway, to cause the anesthetic sprayed therefrom to spray in a desired pattern.

Claim 10. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said nozzle is flexible and may be bent into a desired angulation to intersect with the distal end of a needle of the autoinjector syringe.

Claim 11. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said endothermic gas anesthetic is an aerosol propellant that decreases the temperature of a user's skin to cause numbness. Claim 12. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said endothermic gas anesthetic is a mixture of more than one aerosol propellants that decreases the temperature of a user's skin to cause numbness.

Claim 13. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said endothermic gas anesthetic is an aerosol propellant that decreases the temperature of a user's skin to cause numbness, said endothermic gas anesthetic including an anti-bacterial.

Claim 14. The autoinjector syringe and endothermic gas anesthetic assembly of claim 2 wherein said canister containing said endothermic gas anesthetic is a metal canister having a valve assembly crimped and sealed within an open end of said canister to create a sealed pressure canister, said valve assembly including a dispenser tube extending outwardly therefrom.

Claim 15. A method of using an autoinjector syringe with an attached endothermic gas anesthetic assembly comprising the steps of:

placing the autoinjector syringe against the injection site;

depressing the base portion of canister containing compressed endothermic gas anesthetic, causing the valve assembly of said canister to be opened allowing the pressurized gaseous anesthetic to be directed through a nozzle to the skin thereby numbing the injection site;

pressing the thumb pad of the autoinjector syringe causing the medicine within the autoinjector syringe to be injected subcutaneously into the numbed injection site; lifting the autoinjector syringe and the endothermic gas anesthetic assembly away from the injection site.

Description:
METHOD AND APPARATUS FOR APPLYING

AN ANESTHETIC AND BACTERICIDE

FIELD OF THE INVENTION

Generally, the invention relates to an apparatus for applying an anesthetic to a patient. In particular, the apparatus comprises a receptacle for a liquefied endothermic gas and system for dispensing the endothermic gas which is removably attached to asyringe barrel.

BACKGROUND

Syringes are employed millions of times daily all over the world to inject medicines into people as well as animals. Many times, injections are made in areas of the body that are somewhat less sensitive to pain. Other locations of the body where injections are contemplated are significantly more sensitive to pain and the patient feels a pinching sensation that may be quite painful as the syringe needle is inserted beneath the skin. Such areas include, for example, gums, areas of the face such as the forehead, as well as the lips.To minimize the pain that results when the injection needle penetrates, for example, a patient's gums, the dental practitioner will often apply a topical agent to the injection site using a cotton swab. Because the deadening agent is only applied topically, it is not effective as it does not cross the skin/mucosal membranes and misleads the patient into a false expectation of a painless injection. As a result, injecting an anesthetic often causes significant pain at the injection site. In other cases, such as diabetics, patients may be required to self-medicate on a daily basis. The repeated injections often create sensitive areas where injections are painful to the patient. This pain may cause patients to delay or omit medication to avoid the pain associated therewith.

SUMMARY

There is currently a need for a means of minimizing the pain associated with an injection. The present invention addresses this need by providing a syringe having a liquid anesthetic, or a liquid anesthetic cartridge and a compressed gas or vaporcanister therein, or a receptacle for receiving a gas or vapor canister, wherein the receptacle comprises a clip for attaching a syringe, e.g. piggyback. One chamber within the syringe or syringe cartridge includes a conventional anesthetic while the canister includes a compressed, endothermic gas or vapor that rapidly absorbs heat when released to the atmosphere; the endothermic gas or vapor is first applied to the injection site prior to the anesthetic injection to minimize the pain associated with conventional anesthesia techniques. Furthermore, the gas or vapor also blanches the mucosa (along with popping bubbles due to the boiling of the liquid phase),allowing a practitioner to readily identify the pretreated injection site so that the needle is not inserted into an unanesthetized area.

Embodiments of the invention are also directed to an apparatus comprising a syringe, a receptacle which is removably attached to the syringe barrel and which accommodates a canister comprising a gaseous (vaporous) anesthetizing composition. The receptacle further comprises an elongated nozzle or a short nozzle for attaching a tube. The apparatus comprises an actuating member which acts to dispense the contents of a container or canister containing the anesthetic composition. The actuating member comprises a lever and a spring biased means for the controlled release of the gaseous (vaporous) anesthetizing composition.

Embodiments of the invention are further directed to a gaseous anesthetizing canister assembly for attachment to a single use autoinjector type syringe. The anesthetizing canister assembly includes a collar that surrounds the autoinjector syringe for attachment. The canister assembly contains a high pressure canister filled with endothermic gas and a trigger mechanism for releasing the endothermic gas through a nozzle. The nozzle provides a predetermined spray pattern for directing the endothermic gas toward the skin to provide an anesthetized area. The autoinjector syringe can then be activated to insert the needle into the anesthetized area without pain to the user.

Other aspects are described infra. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a plan view of the dental syringe with the cartridge and canister removed therefrom.

Figure 2 is a plan view of the dental syringe with the cartridge and canister installed in their corresponding chambers.

Figure 3 is a perspective view illustrating an alternative embodiment of the present invention.

Figure 4A is an exploded view of one embodiment of a module of the present invention.

Figure 4B is a perspective view of the embodiment illustrated in Figure 4A attached to a syringe.

Figure 4C is a perspective view of the module of Figure 4A.

Figure 4D is an exploded view of the module of Figure 4A.

Figure 5Ais a perspective assembly view illustrating an alternative embodiment of the present invention having a remote tank for holding an endothermic gas or vapor.

Figure 5B is a perspective assembly view illustrating an alternative embodiment of the present invention having a remote tank for holding an endothermic gas or vapor.

Figures 5C is a perspective view of an alternative embodiment of the present invention.

Figure 5D is a partially exploded view of the embodiment illustrated in

Figure 5C.

Figure 5E is a perspective view of an alternative embodiment of the present invention.

Figure 5F is a partially exploded view of the embodiment illustrated in

Figure 5E.

Figure 5G is an exploded view of the embodiment illustrated in Figure 5E. Figure 5H is a section view taken along lines 5H-5H of Figure 5D.

Figure 51 is a partially exploded view of the embodiment illustrated in

Figure 5H. Figure 5J is a perspective view of an alternative embodiment of the present invention.

Figure 5K is a partially exploded view of the embodiment illustrated in

Figure 5J.

Figure 6 is a plan view of a syringe with the canister installed in the module or adjunctive chamber.

Figure 7 is a perspective view of the embodiment illustrated in Figure 6. Figure 8 is a partially exploded front view of the embodiment illustrated inFigure 6.

Figure 9A is a perspective view of one embodiment of the dispenser cap of the present invention.

Figure 9B is a front view of the dispenser cap illustrated in Figure 9A.

Figure 9C is a section view taken along lines 9C-9C of Figure 9B.

Figure 10A illustrates one embodiment of an adjunctive chamber suitable for use with the present device.

Figure 1 OB is a front view of the adjunctive chamber illustrated in Figure

10A.

Figure IOC is a side view of the adjunctive chamber illustrated in Figure 10A.

Figure 10D is a rear view of the adjunctive chamber illustrated in Figure

10A.

Figure 10E is a top view of the adjunctive chamber illustrated in Figure 10A.

Figure 1 OF is a section view of the adjunctive chamber taken along lines lOF-lOF of Figure lOE.

Figure 1 1 A is a perspective view of one embodiment of the sleeve of the present invention.

Figure 1 IB is a top view of the sleeve illustrated in Figure 1 1A.

Figure 1 1C is a bottom view of the sleeve illustrated in Figure 1 1 A with portions illustrated in phantom.

Figure 1 ID is a front view of the sleeve illustrated in Figure 1 1 A. Figure 12A is a perspective view of one embodiment of the lever of the present invention.

Figure 12B is a top view of the lever illustrated in Figure 12A.

Figure 12C is a left side view of the lever illustrated in Figure 12 A.

Figure 12D is a right side view of the lever illustrated in Figure 12A.

Figure 12E is a top view of the lever illustrated in Figure 12 A.

Figure 13A is a top isometric view of one embodiment of an autoinjector syringe suitable for use with the present invention.

Figure 13B is a top isometric view of one embodiment of an adjunctive chamber suitable for use with an autoinjector syringe.

Figure 14 is a top isometric view illustrating the adjunctive chamber secured to the autoinjector syringe of Fig. 13 A.

Figure 15 is a top isometric view illustrating insertion of a gas canister into the autoinjector syringe.

Figure 16 is a top isometric view illustrating the fully assembled adjunctive chamber and autoinjector syringe.

Figure 17 is an isometric view of an adjunctive chamber.

Figure 18 is an exploded view of the adjunctive chamber of Figure 17.

Figure 19 is an exploded view of an autoinjector syringe.

Figure 20A is an assembled view of the autoinjector syringe and an adjunctive chamber illustrating a method of using the assembly.

Figure 20B is an assembled view of the autoinjector syringe and an adjunctive chamber illustrating a method of using the assembly.

Figure 20C is an assembled view of the autoinjector syringe and an adjunctive chamber illustrating a method of using the assembly.

Figure 20D is an assembled view of the autoinjector syringe and an adjunctive chamber illustrating a method of using the assembly.

DETAILED DESCRIPTION

It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.

Referring to Figures 1-20, embodiments of the present invention relate to a method and apparatus of applying an anesthetic. In some embodiments, the apparatus comprises an elongated tubular housing 1 having an outer wall 2, an upper end 3, a substantially hollow interior, and a lower end 4 having an injection needle 5 extending therefrom. On the housing outer wall is an elongated opening 6 in communication with an anesthetic chamber 7 formed within the housing interior. The anesthetic chamber receives a cartridge 8 having a conventional dental anesthetic stored therein.

The outer wall also includes a smaller opening 9 that is in communication with an adjunctive chamber 10 for receiving a canister 1 1. The canister includes an endothermic gas (vapor) or "freeze spray" solution that rapidly absorbs heat when dispersed into the atmosphere.

Coaxially received within the anesthetic chamber 7 is a plunger 12 having a thumb ring 13 at an upper end and a spear 14 at a lower end; the spear penetrates a membrane on the upper end of the anesthetic cartridge 8 to force fluid therein into the injection needle 5.

Coaxially received within the adjunctive chamber 10 is a depressible trigger 15 having a handle 16 at an upper end that protrudes from the upper end of the housing. Depressing the trigger opens the valve assembly 17 of the canister 1 1 ,propelling the gaseous or vaporous solution contained within canister 1 1 through an outlet nozzle 20 on the lower end of the housing. The nozzle 20 is oriented to project a stream of gas or vapor along a delivery axis 31 that intersects a delivery axis 30 of the needle, preferably at a point 40 immediately adjacent to the needle outlet. Accordingly, a practitioner can first deaden a proposed injection site and then immediately insert the needle with little movement or repositioning of the syringe.

The method of applying an anesthetic using the syringe described above includes initially dispersing the heat-absorbing, endothermic gas or vaporfrom the canister 1 1 onto a proposed injection site by depressing the trigger 15. Because of its physical properties, the heat-absorbing substance constricts blood flow at the injection site, and temporary numbing occurs. The freeze spray stops the propagation of the painful nerve stimuli, and the patient feels the tactile or pressure as opposed to the pain sensation. The pressure nerve fibers supersede the painful nerve fibers so that the mechanical contraction of the muscles blocks the transmission of pain perception, according to the Gate theory. The use of the endothermic "freeze spray" also temporarily distracts the patient by creating a "popping" noise (due to the boiling of the liquid under pressure) that diverts the patient's attention away from any potential or anticipated pain. Finally, because the solution blanches the mucosa, a readily-visible target is created for insertion of the needle to assure that the deadened area is not bypassed. The aerosol propellants or gas (vapor) used as anesthetic hereinavoid the drawbacks associated with traditional anesthetics. The gas or vapor freezes (blanches) the area of administration, allowing for the painless insertion of the needle to deliver the pharmaceutical drug, vaccine, BOTOX ® , hair transplant and the like.

When the practitioner observes that the injection site mucosa has been blanched, the site is effectively deadened and a painless, concomitant injection is possible. The practitioner can then quickly inject the anesthetic into the blanched injection site by inserting the injection needle 5 and depressing the plunger 12. Because of the positioning of the gas or vaporoutlet nozzle 20 and needle outlet21 , the dispersal of the gas or vapor and subsequent injection of anesthetic can be accomplished almost concurrently and with no pain to the patient.

Referring to Figures 3, 4A-D, 9A-C, 10A-F, 1 1A-D and 12A-E,alternative embodiments of the present invention are illustrated. In these embodiments, an apparatus comprising a module 44 is removably attached to a syringe barrel 62 and accommodates a canister 1 1 comprising a gaseous(vapor) anesthetizing composition. The module 44includes an elongated outlet nozzle 20 for directing the gaseous (vapor) anesthetizing composition to intersect with thedelivery axis 30(FIG. 2) of the needle 5. The module includes an adjunct chamber frame 56, attachment means in the form of clips 23 or a sleeve 48, a trigger 15 and an outlet nozzle 20. The adjunct chamber frame 56 functions to contain the canister 1 1 , as well as providing support for the trigger 15, clip(s) 23 and the dispenser cap 54. Thetrigger member 15(Fig. 12A-E) functions to dispense the contents of the canister 1 1 containing the anesthetic composition by forcing the canister to slide within the adjunctive chamber 10 of the adjunct chamber frame 56. During the sliding action, the dispensing tube 58 of the canister 11 is pressed against the dispenser tube shoulder 55 to cause the canister valve 17 to open allowing compressed gas to escape through the dispenser tube 58.The trigger 15 is secured to the adjunct chamber frame 56 via pivot pins 60. The pivot pins 60 cooperate with pivot apertures 59 in the adjunct chamber frame 56. The pivot pins are positioned to allow the trigger to rotate thereabout so that the handle 16 can be utilized to force the ram 66 against the base of the canister 1 1 to cause the movement within the adjunctive chamber 10 to allow the pressurized gas to be released. A biasing means in the form of a spring 68 may be utilized to return the trigger to its original position.In some embodiments, the module 44 is disposable. In other embodiments, the syringe 42 is disposable. In yet other embodiments, the canister 1 1 is disposable. In other embodiments, any one or combination of parts of the apparatus is disposable.

Still referring to Figures 3, 4A-D, 9A-C, 10A-F, 1 1A-D and 12A-E,the module 44 includes an adjunctive chamber 10 for accepting a gas cartridge 8. The outer diameter of the module includes an attachment means which may comprise a clip 23 (Fig. 3) or sleeve 48 (Fig. 4A) which are adapted to cooperate with the outer diameter of a syringe barrel 62 for securing the module to the syringe. The clip 23 preferably includes a pair of arcuate members 24made of a flexible resilient material so that the arcuate members may be temporarily enlarged by flexing to allow the arcuate members to snap over the outer diameter of the syringe barrel 62. In this manner, the module may be attached to syringe barrels of differing diameters to provide versatility to the device. The sleeve member 48 is also constructed from a flexible resilient material, such as plastic, and includes a slot 49 extending between two barrels 45, 47. In operation, the slot 49 may be expanded to allow the first and second barrels 45, 47 to be slipped over the outer diameter of the module 44 and the syringe 42. A fastener 51 may be provided to compress the slot 49 in the sleeve member 48 to prevent slippage of the assembly during use.

Referring to Figures 9A-C, the dispenser cap is illustrated. The dispenser cap is used to close the end of the adjunct chamber frame 56 and to cooperate with the valve assembly 17 to cause the pressurized gas to be dispensed. In the preferred embodiment, the first end of the dispenser cap includes threads 70 which secure the dispenser cap to the adjunct chamber frame 56. Alternatively, adhesive, bayonet mount, friction fits or the like may be utilized to secure the dispenser cap to the adjunct chamber frame without departing from the scope of the invention. This is best seen in FIGS. 9 and 10, wherein the threaded cap 54comprises an opening 27 and an engagement means, e.g. a valve aperture 55to engage the canister and for delivery of metered doses of aerosol propellants.A restrictor jet 74 may be utilized to control the flow of gas through the outlet tube. The second end of the dispenser cap includes an outlet nozzle bore 72 sized to cooperate with the outlet nozzle 20 for positioning thereof. In the preferred embodiment, the outlet nozzle 20 is adhered or frictionally fit to the dispenser cap. The outlet nozzle 20 can be rigid, flexible or semi-flexible. The outlet nozzle 20is tubular in construction,having a distal end 140(FIG. 8)with an opening 52that may, if desired, be defined by an insert,e.g. nozzle, venturi or the like, inserted into the opening 52 and having a particularly configured passagewayto cause the anesthetic sprayed therefrom to spray in a desired pattern. The distal end of the nozzle 20 can be flexible, and may be bent by a physician into a desired angulation so that the anesthetic is sprayed in a desired location with respect to the location where the syringe needle will be inserted beneath the skin of the patient. The needle 5 can be varied in length, for example, shortened or elongated, so it extends beyond the distal termination of the outlet nozzle 20so that the nozzle 20doesn't interfere with insertion of the needle subcutaneously.

As shown in Figure 3, a disposable syringe 42is illustrated in conjunction with the module 44 of the present invention. The disposable syringe includes an elongated barrel 62 that is typically cylindrical in outer configuration, a plunger 12 having a thumb pad 43or ring 13(FIG. 1) that is engaged by the thumb or finger of the user, and a perpendicular tab 6 Ion the barrel 62 of the syringe 42 that is grasped by other fingers of the user while the ring or padl3, 43 is being pushed to cause the plunger 12 to move in a direction toward the distal end 50of the barrel 62. The plunger 12 pushes the medicament or liquid in the chamber 7 through the needle. The needle 5 is attached to the distal end of the syringe viaa locking taper, luer lock 46,or the like, to allow fluid to flow into and through the needle 5. As is well known, the needle is thin and hollow, permitting the medicament within the chamber 7to be dispensed therethrough. The needle 5 can be of any length so long as its distal end extends beyond the end ofoutlet nozzle 20.

In the various embodiments, the anesthetic comprises one or more gas, vapor or aerosol propellants. These propellants can be any type of aerosol propellants as long as they continue to decrease the temperature of the patient's skin or mucosal area targeted for an injection; examples are the aerosol propellants sold by DuPont Company, Wilmington, DE, under the trade names DYMEL™ 134a and DYMEL™ 227a. In preferred embodiments, the anesthetic comprises a blend of two aerosol propellants in varying percentages of weight/weight (w/w). The range of DYMEL™ 134a can be from about 0.001% to 99.999% w/w and the weight of DYMEL™ 227a can be from about 0.001%) to 99.999% w/w. In other embodiments, one or more compounds, pharmaceutical grade compounds or compositions can be included, for example, compounds which alter the vapor pressure of the gas or vapor being emitted. Pharmaceutical compounds include, for example, antimicrobial, taste altering compounds or flavoring compounds, e.g. menthol, mint, etc., therapeutically effective compounds and the like.In preferred embodiments, the aerosol propellants (e.g. DYMEL™ 134a, DYMEL™ 227a) are pharmaceutical grade and shown to be safe for inhalation, ingestion, and for use in sensitive areas of a patient, e.g. eyes, lips, nose etc. These pharmaceutical grade aerosol propellants can be obtained from DuPont Company, Wilmington, DE.

The anesthetic is preferably contained within a small or specialized canister of the type typically utilized for metered dose inhalers (e.g., asthma) and includes a deep drawn metal canister constructed from a metal such as aluminum or steel. The deep drawn canister 1 1 (FIG. 4D)includes a valve assemblyl 7crimped and sealed within the open end of the metal canister to create a sealed pressure canister that is light weight and portable. The aerosol propellants are contained within the metal canister under pressure so that depression of the dispenser tube 58 releases the propellant through the valve assembly. In operation, the dispenser tube 58 of the valve assemblyl 7 may be operated in a variety of manners which may include, but should not be limited to, finger nozzles, levers, cams, solenoids or the like, which permit the valve to be depressed for release of the propellant. The location on the surface area of the patient where an injection is to take place is determined, and the syringe 42 with the module 44 attached thereto is positioned at a desired location and angle of skin penetration approximately 1 to 2 centimeters above the skin. The lever 15 is depressed to engage the valve to permit flow of the anesthetic,e.g. an aerosol propellant (vapo-coolant), for a period of time, such as 1 to 3 seconds. The skin is then penetrated by the needle 5 of the syringe 42 to a desired depth and the medicament is injected to numb in a separate location either while the aerosol propellant is flowing, or just after the flow of the aerosol propellant is stopped. Injections may be firstsubcutaneous, then intramuscular or intradermal. The anesthetic can be administered at various depthsin sequence of the dermal layers to make sure that the area is numb, such that a patient will not feel any pain when the needle, e.g. i.v. injection is inserted. In some embodiments, the first dermal or skin layer is numbed first, and then the next layer etc., in sequence.If desired, the needle may be retracted a desired distance, with additional injection occurring, or may be removed so that the next location can be chosen. During the step- wise process of injection including multiple injections at the same site of needle penetration, additional aerosol propellants may be dispensed as desired to maintain the numbness of the skin at that location. If, during the process of injection, the canisterl 1 runs out of anesthetic, e.g. an aerosol propellant, it may be removed from the adjunct chamber frame 56 and replaced with a replacement canister. In embodiments where a large area is targeted for numbing, a larger volume or quantity of aerosol propellant in a large canister 90can be utilized so as not to contaminate the field or location and to prevent cross contamination(FIGS. 5A, 5B). In some embodiments, the apparatus comprises an assembly200 (FIGS. 5A, 5B)which is attachable to a user's clothes or belt, or a back-pack carrying any further number of doses of propellant. In this manner, the user is not required to replace a spent canister. The assembly200 is connected to the remote valve assembly 80 via a long flexible tube91 which can be extended or retracted as needed by the user, and is actuated in a similar manner as with the smallercanister 1 1, or the tube is connected to the canister, thereby providing a reservoir of aerosol propellant.The canister may alsobe refillable, and may additionally include regulators or the like known in the art for reducing pressure from large high pressure tanks. When the injection process is completed, the syringe 42 may be removed from the clip portion 23 and suitably discarded, and the module 44 may be re-used with other syringes or for single use per point to prevent cross-contamination. It should also be noted that while the preferred embodiment entails placing the large canister in a fixed position, the canister may optionally include an attachment means for securing the canister to the belt or back of the user to provide mobility to the user while still providing the added capacity of the larger canister.

As such, in this way the present invention provides an effective way of dispensing an anesthetic onto the skin of a patient where an injection is to take place so that the injection is painless. The present invention is not limited for use in association with injections in the face for aesthetic enhancement. Rather, it may be used as an attachment to any syringe or other injection device used to inject any medication for any purpose. For example, the inventive device may be used with injection devices associated with diabetes glucose monitors, BOTOX ® , hair transplants, multiple needle allergy introducers and the like.

Referring to Figures 1 and 2, the apparatus comprises an elongated tubular housing 1 having an outer wall 2, an upper end 3, a substantially hollow interior, and a lower end 4 having an injection needle 5 extending therefrom. On the housing outer wall is an elongated opening 6in communication with an anesthetic chamber 7 formed within the housing interior. The anesthetic chamber receives a cartridge 8 having a conventional dental anesthetic stored therein.

The outer wall 2can also include a smaller opening 9 (FIG. 1) which is utilized as the receptacle or adjunctive chamber 10 for receiving a canister 11 (FIG.2).The canisterl 1 includes an endofhermic gas or vapor, or "freeze spray" solution that rapidly absorbs heat when dispersed into the atmosphere. Coaxially received within the anesthetic chamber is a plunger 12 having a thumb ring 13 or other means for pushing the plunger at an upper end.

Coaxially received within the adjunctive chamber 10 is a depressible trigger 15 having a handle 16 at an upper end that protrudes from the upper end of the housing. Depressing the trigger propels the gaseous or vapor propellant through an outlet nozzle 20 on the lower end of the housing. The nozzle 20 is oriented to project a stream of gas or vapor along a delivery axis that intersects a delivery axis of the needle, preferably at a point immediately adjacent to the needle outlet 21. Accordingly, a practitioner can first deaden a proposed injection site and then immediately insert the needle with little movement or repositioning of the syringe.

Referring to Figures 6-8, an alternative embodiment of the present device is illustrated. This embodiment utilizes a reusable syringe in combination with the module 44 and the sleeve 48 for attaching the module to the syringe. This embodiment also illustrates that the module and the sleeve may be constructed from metal without departing from the scope of the invention.

In some embodiments, the module 44 may be constructed and arranged to accommodate two or more canisters 1 1. The arrangement of the two or more canisters or modules can be arranged in any manner and can be of varying dimensions and shapes. For example, the modules can be attached together. In some embodiments, the modules 44 are arranged to be on either side of the syringe. One of ordinary skill in the art can envisage possible combinations, locations, patterns and designs for the receptacles.

Referring to Figure 8, the container or canister 1 1 which contains one or more gases or vapors comprises a neck 1 1 1 having an end cap 1 12 and a dispenser tube 58 dimensioned for slidable insertion and engagement of the dispenser cap 54of the module 44 (FIG. 8). Thecanister contents can be any type of anesthetic. In someembodiments, the anesthetic comprises one or more gases (vapors); examples include, without limitation, aerosol propellants, endothermic gases (vapors) and refrigerantsthat rapidly absorb heat when released from pressure to the atmosphere and the like. Accordingly, a user can initially disperse the gas or vaporcomposition onto the injection site to minimize any pain and discomfort associated with an injection. Subsequently, the practitioner inserts the needle into the deadened site (blanched) and injects the contents of the syringe. As discussed above, the receptacle can be of any size and shape to accommodate canisters or containers of varying sizes and shapes. The size of the canisters used depends on the volume of the anesthetic, e.g. gas or vapor needed for the particular procedure. Different blends produce different temperatures; therefore, the doctor in charge can decide which of the blends to utilize for the necessary effect. In someembodiments, the temperature of the gas or vaporwhen administered is above freezing temperatureto avoid necrosis, frost bite, pain, discomfort or any type of biological damage to the area of administration. Since the medical caregiver, e.g. doctor, controls the delivery of the anesthetic, e.g. gas or vapor, the doctor is in charge of the delivery of the gas or vapor to enhance the patient comfort, therefore,the doctor can add additional bursts if the patient informs the doctor that more is needed.

Referring to Figures 5C-K, an alternative embodiment of the present invention is illustrated. In this embodiment, the module 144 is constructed and arranged to be secured to the syringe 42 in a perpendicular arrangement with respect to the syringe. The adjunct chamber frame 156 is still constructed to allow the insertion of a portion of the canister 1 1. The distal end of the adjunct chamber frame 156 includes the dispenser tube shoulder 55 for accepting the dispenser tube 58. In this embodiment, the trigger 1 15 is constructed and arranged to cooperate with the neck 11 1 of the canister 11 to provide controlled dispensing of the pressurized gas. The trigger 1 15 is provided with a pivot pin 160 which allows the ram 166to catch under the neck to cause the canister to move within the adjunct chamber frame. Return spring 168 returns the trigger to its original position. An outlet tube 120 extends out of the adjunct chamber frame 156 at an angle that is substantially perpendicular with respect to the canister 11. The outlet tube 120, therefore, provides a body to cooperate with the sleeve 48 or clip 23 for ready attachment to reusable or disposable syringes. The outlet tube 120 also functions to secure and position the outlet nozzle 20, which may be telescopingly engaged to the outlet tube to allow the length of the outlet nozzle to be adjusted.

It should also be noted that, while not shown, a small laser light or the like may be secured to the module 44, 144 to indicate the trajectory of the pressurized gas. In this manner, the user would be provided with a visual guide to where the gas will strike the patient's skin.

The above-described device is not limited to the exact details of construction and enumeration of parts provided herein. For example, the receptacle could comprise separate components, e.g. a separate clip that is attachable to the receptacle and to any conventional syringe. The endothermic gas or vapor should remove sufficient heat to function as described without causing necrosis. The concentration and volume of the propellant components can be varied to deliver small doses of highly-concentrated substances, or a prolonged, continuous dispersal of diluted substances.The canister can also be color coded for varying temperatures produced by the different blends or aerosol propellants. In addition, gas or vapor delivery can be automated with a laser mechanism that dispenses gas or vapor when the needle is within a minimal distance from the skin and automatically disables gas or vapor flow upon needle penetration. Accordingly, a practitioner can rapidly inject multiple sites. Finally, although the device has been primarily described and depicted as a syringe, the gas or vaporous canister could have other uses. For example, it could be attached to a scalpel blade to allow a quick, painless incision when performing certain procedures, such as removing moles. Furthermore, the size, shape and materials of construction of the various components can be varied.

Referring to Figures 13A-B, 14-19 and 20A-D, alternative embodiments of the present invention are illustrated. In these embodiments, an apparatus comprising a module 44 is removably attached to anautoinjector syringe barrel 162, and accommodates a canister 1 1 comprising a gaseous (vapor) anesthetizing composition. The module 44 includes an elongated outlet nozzle 20 for directing the gaseous (vapor) anesthetizing composition to intersect with thedelivery axis 30 of the needle 5. The module includes an adjunct chamber frame 56, attachment means in the form of a securable clip 123 or a sleeve 48, a latch 124, an outlet nozzle 20 and a dispenser cap 54. The adjunct chamber frame 56 functions to secure the adjunct chamber to the autoinjector syringe barrel 162, andcontains the canister 1 1 as well as the securable clip(s) 123 and the dispenser cap 54. In this embodiment, the canister base 11 1 functions as the trigger member 15(Fig. 12A- E) functions to dispense the contents of the canister 1 1 containing the anesthetic composition by forcing the canister to slide within the adjunctive chamber 10 of the adjunct chamber frame 56. During the sliding action, the dispensing tube 58 of the canister 1 1 is pressed against the dispenser tube shoulder 55 to cause the canister valve 17 to open, allowing compressed gas to escape through the dispenser tube 58. The canister 1 1 of the cartridge 8 is frictionally secured within the adjunct chamber frame 56 to allow the sliding action. Pressure and/or springs within the valve assembly 17 function to stop the flow of gas when pressure is released from the base of the canister 1 1 1 or the trigger 15. Latch pivot pins 125 cooperate with latch pivot pin apertures 127 in the adjunct chamber frame 56 to allow the securable clip 123 to be pivoted between an open position Fig. 13B and a closed position around the autoinjector syringe 162 Fig. 14. In some embodiments, the module 44 is disposable. In other embodiments, the autoinjector syringe 162 is disposable. In yet other embodiments, the canister 11 is disposable. In other embodiments, any one or combination of parts of the apparatus is disposable.

Still referring to Figures 13A-B, 14-19 and 20A-D,the module 44 includes an adjunctive chamber 10 for accepting a gas cartridge 8 in the form of a canister 1 1. The outer diameter of the module includes an attachment means which may comprise a securable clip 123 which is adapted to cooperate with the outer diameter of an autoinjector syringe barrel 162 for securing the module to the autoinjector syringe. The securable clip 123 preferably includes a pair of arcuate members 126 made of a resilient or rigid material so that the arcuate members may be closed around the outer diameter of the autoinjector syringe barrel 162 and latched in place via latch 124. The latch 124 is rotatably secured to the adjunct chamber frame 56 to allow the latch pin 128 to engage the latch slot 130. In this manner, the module may be securely attached to autoinjector syringe barrels to prevent slippage during use. In at least one embodiment, orientation tabs are provided to insure a preferred orientation between the autoinjector syringe 162 and the module 44.

Referring to Figure 18, one embodiment of the dispenser cap 54 is illustrated. The dispenser cap is used to close the end of the adjunct chamber frame 56 and to cooperate with the valve assembly 17 to cause the pressurized gas to be dispensed. In the preferred embodiment, the outlet nozzle 20 includes a pocket 134 sized to contain the dispenser cap. A pilot shaft 136 is utilized to align and secure the dispenser cap to the adjunct chamber frame 56 via fastener 138. Alternatively, adhesive, bayonet mount, friction fits or the like may be utilized to secure the dispenser cap to the adjunct chamber frame without departing from the scope of the invention. A restrictor jet 74 (Fig. 9C) may be utilized to control the flow of gas through the outlet tube. The second end of the dispenser cap includes an outlet nozzle bore52 sized to cooperate with the outlet nozzle 20 for directing the flow of gas. The outlet nozzle 20 of the preferred embodiment is rigid; however, flexible or semi-flexible outlet nozzles may be utilized without departing from the scope of the invention. The outlet nozzle 20 is tubular in construction,having a distal end 140with an opening 52(Fig. 8)that may, if desired, be defined by an insert e.g. nozzle, venturi or the like, inserted into the opening 52 and have a particularly configured passagewayto cause the anesthetic sprayed therefrom to spray in a desired pattern. The distal end of the nozzle 20 can be flexible, and may be bent by a physician into a desired angulation so that the anesthetic is sprayed in a desired location with respect to the location where the syringe needle will be inserted beneath the skin of the patient. The needle 5 can be varied in length, for example, shortened or elongated, so it extends beyond the distal termination of the outlet nozzle 20 so that the nozzle 20doesn't interfere with insertion of the needle subcutaneously.

Referring to Figure 19, an exploded view of an autoinjector syringe 142 is illustrated in conjunction with the module of the present invention. The autoinjector syringe 142includes an elongated barrel 162 that is typically cylindrical in outer configuration, a plunger 12 having a thumb pad 43 or ring 13 (Fig. 1) that is engaged by the thumb or finger of the user to cause the plunger 12 to move in a direction toward the distal end 50of the barrel 162via spring member 144. The plunger 12 pushes the medicament or liquid in the chamber 7 through the needle. The needle 5 is attached to the distal end of the syringe via locking taper, press fit, luer lock 46 or the like, to allow fluid to flow into and through the needle 5. As is well known, the needle is thin and hollow, permitting the medicament within the chamber 7 to be dispensed therethrough. The needle 5 can be of any length so long as its distal end extends beyond the end of outlet nozzle 20. A top cap 146 and a needle cap 148 may be included with the autoinjector syringe to prevent inadvertent activation of the autoinjector syringe during shipping and travel. This construction permits the autoinjector syringe to be preloaded and carried for use as needed.

Referring to Figures 20A-D, operation of the autoinjector syringe with the module secured thereto is illustrated. If included, the top cap 146 and needle cap 148 are removed prior to placing the autoinjector syringe above the injection area 9 (Fig. 20A). The base portion 111 of the canister 11 is pressed, causing the valve assembly 17 to be openedand allowing the pressurized gaseous anesthetic to be directed through the nozzle 20 to the skin, thereby numbing the injection site (Fig. 20B). The thumb pad 43 is pressed after the autoinjector syringe 142 is placed onto the injection area (Fig. 20C). Once the injection is complete, the autoinjector syringe and module assembly are lifted away from the injection site as normal (Fig. 20D). One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.