Handheld medical substance dispensing system, apparatus and methods

Various handheld medical dispensing configurations and methods including the following. Handheld medical dispensing system comprises a syringe, which has a plunger, releasably mounted to syringe actuation apparatus, the apparatus having an actuator configured such that it can move the plunger more than once to dispense a plurality of amounts of substance from the syringe. A method of dispensing fluid from a syringe comprises holding a medical substance delivery system including a syringe, which has a needle, and which is secured to syringe actuation apparatus configured to dispense predetermined amounts of the substance from the syringe, penetrating the needle at one patient site and using the apparatus to deliver a predetermined amount of the substance, and penetrating the needle at another patient site and using the apparatus to deliver a predetermined amount of the substance.

FIELD OF THE INVENTION

The invention relates to syringes generally and more particularly to syringe dispensing or injection apparatus.

BACKGROUND OF THE INVENTION

In the field of plastic surgery, non-invasive procedures have enjoyed increasing popularity over the past ten years. The most common procedures include injection of liquid fillers in facial lines and wrinkles as well as the use of agents which paralyze selective muscles of the face in order to provide diminishment and smoothing of wrinkles. Typically, a dermal filler or paralytic agent such as Botox®Cosmetic (onabotulinumtoxinA), is used on a recurrent outpatient basis. Such agents typically are available in sterile vials of product in freeze-dried form. The clinician will reconstitute the preparation according to a specific recipe of sterile saline (fluid) added to the vial of product. Once mixed, the preparation is drawn up into a syringe, for subdermal delivery using a small bore medical needle. The most common delivery method uses a one cc disposable syringe which is fitted with a disposable needle. Importantly, small, reproducible allotments of the fluid are delivered via multiple injections into the muscles of the face, such as the frontalis muscle in a field of the face which would benefit from treatment.

Further, it is well known that the use of a small syringe during injections of the face on a subject who is sitting in a chair is generally uncomfortable for the health care provider and subject to unsteady maneuvering of the syringe due to the necessity of pushing on the plunger which is located at the rear end of the syringe assembly, while trying to hold the syringe steady. Accordingly, there remains a need to provide a handheld dispenser or syringe that can be more stable or desired filler or fluid amounts from a handheld dispenser or syringe in such applications in order to provide predictable and/or desired results.

SUMMARY OF THE INVENTION

The present invention involves improvements in medical substance delivery systems such as medicinal substance delivery systems for the treatment of facial lines and/or wrinkles.

According to one embodiment or the invention, a handheld medical or medicinal substance dispensing system comprises a syringe having a barrel and a plunger; and syringe actuation apparatus to which the syringe is releasably mounted, the syringe actuation apparatus having an actuator configured such that it can move the plunger more than once to dispense a plurality of amounts of substance from the syringe. Alternatively, a plurality of volumes can be dispensed.

In one variation of the dispensing system, the syringe actuation apparatus includes a fastener to fasten the syringe to the syringe actuation apparatus.

In another variation of the dispensing system, the syringe includes a needle.

In another variation of the dispensing system, the actuator includes a pusher, which is movably coupled thereto and arranged to engage the syringe plunger, a drive assembly, which is coupled to the pusher to drive the pusher, and a lever, which is coupled to the drive assembly to actuate the drive assembly and which is pivotally coupled to the syringe actuation apparatus, each of the lever and barrel has a distal end portion and a proximal end portion, the lever distal portion being adjacent to and radially spaced from the barrel distal end portion.

In another variation of the dispensing system, a stop member is coupled to the syringe actuation apparatus and has a contact portion, the contact portion is arranged in the path of the lever at a preset location to stop advancement of the lever arm at the preset location such that the pusher and plunger can be moved a preset amount to dispense a predetermined amount of substance from the syringe. Alternatively, a predetermined volume or a desired or preset amount (or volume) can be dispensed.

In another variation of the dispensing system, the contact portion position is adjustable such that the predetermined amount of substance to be dispensed from the syringe can be varied. Alternatively, a predetermined volume of substance to be dispensed or a desired or preset amount (or volume) of substance to be dispensed can be varied.

In another variation of the dispensing system, the syringe includes a needle fluidly coupled to the barrel and the syringe actuation apparatus includes a lever actuator movably mounted thereto, the syringe actuation apparatus further including a stop member arranged in the path of the lever actuator at a preset location to stop advancement of the lever actuator at a preset location.

In another variation of the dispensing system, the stop member has a contact portion that the lever contacts upon full advancement of the lever, the contact portion position being adjustable.

In another variation of the dispensing system, the syringe actuation apparatus with the syringe mounted thereto is configured such that it can be held in one hand of a user and operated only with that hand. In one example, the actuator includes a lever that is pivotally mounted to the syringe actuation apparatus with its free end adjacent the distal end portion of the syringe barrel.

In another variation of the dispensing system, the actuator is configured such that it can be preset to permit moving the plunger a preset distance more than once.

In another variation of the dispensing system, the actuator is configured such that it can move the plunger a preset distance more than once to dispense a plurality of predetermined amounts of substance from the syringe. Alternatively, predetermined volumes or a desired or preset amount (or volume) can be dispensed.

In another variation of the dispensing system, the actuator is configured such that it can be preset to vary the distance the plunger travels.

In another variation of the dispensing system, the actuator is configured such that it can be adjusted to dispense different predetermined amounts of substance from the syringe. Alternatively, different predetermined volumes or different desired or preset amounts (or volumes) can be dispensed.

In another variation of the dispensing system, the syringe includes a needle, the syringe actuation apparatus includes a base, and the actuator includes a pusher, which is movably coupled to the base, a drive assembly, which is coupled to the pusher to drive the pusher, and a lever, which is coupled to the drive assembly to actuate the drive assembly and which is pivotally coupled to the base to move from a first position to a second position, the pusher being aligned with the syringe plunger such that the drive assembly can advance the pusher to advance the syringe plunger in the syringe barrel toward the needle, and the actuator being configured such that the pusher can be advanced a preset amount to dispense a predetermined amount of substance from said syringe. Alternatively, a predetermined volume or a desired or preset amount (or volume) can be dispensed.

In another variation of the dispensing system, the system further includes a stop member coupled to the base and arranged in the path of the lever arm at a preset location to stop the lever arm advancement such that the pusher and plunger can be moved a preset amount to dispense a predetermined amount of substance from the syringe. Alternatively, a predetermined volume or a desired or preset amount (or volume) can be dispensed.

In another variation of the dispensing system, the stop member has a contact portion that the lever contacts upon full advancement of the lever, the contact portion position being adjustable such that the predetermined amount of substance to be dispensed from the syringe can be varied. Alternatively, a predetermined volume of substance to be dispensed or a desired or preset amount (or volume) of substance to be dispensed can be varied.

In another variation of the dispensing system, the syringe actuation apparatus is reusable. In one example, the actuator includes a pusher that moves the syringe plunger and the pusher is resettable.

In another variation of the dispensing system, the syringe actuation apparatus includes multiple syringe supports to which the syringe is releasably secured.

In another variation of the dispensing system, the syringe actuation apparatus has a curve shaped surface to which the syringe is releasably mounted.

In another variation of the dispensing system, the syringe contains a pharmaceutical product used in the treatment of facial lines and/or wrinkles.

In another variation of the dispensing system, the syringe actuation apparatus can be configured to dispense, eject, or inject a plurality of amounts (or volumes, doses or dosages) of substance from the syringe.

In another variation of the dispensing system, the syringe actuation apparatus can be configured to dispense, eject, or inject a plurality of predetermined amounts of substance from the syringe. Alternatively, predetermined volumes or desired or preset amounts (or volumes) can be dispensed, ejected, or injected.

In another variation of the dispensing system, the syringe actuation apparatus can be configured to dispense, eject, or inject a plurality of different amounts (or volumes, doses, or dosages) of substance from the syringe. Alternatively, a plurality of different amounts (volumes, doses, or dosages) of substance can be dispensed, ejected, or injected.

In another variation of the dispensing system, the handheld medical or medicinal substance dispensing system is configured such that it can be held in one hand of a user and operated only with that hand, the actuator being preset to provide predetermined amounts of substance when the actuator is actuated. Alternatively, the actuator can be preset to provide predetermined volumes or desired or preset amounts (or volumes) of substance when the actuator is actuated.

In another variation of the dispensing system, the handheld medical or medicinal substance dispensing system can include multiple syringe supports or a generally concave or U-shaped surface for receiving the syringe.

In another variation of the dispensing system, the syringe actuation apparatus can include a stop member arranged at a location to stop advancement of the actuator at a preset location, where in one option the stop member location can be adjustable.

In another variation of the dispensing system, the dispensing system actuator can comprise a lever actuator movably mounted (e.g. pivotally mounted) thereto, and the syringe actuation apparatus can include a stop member arranged in the path of the lever actuator at a preset location to stop advancement of the lever actuator at a preset location, where according to one option the stop member location can be adjustable and set to another preset location.

According to another embodiment of the invention, a handheld medical dispensing system comprises a syringe having a barrel, plunger, and needle; and syringe actuation apparatus having a base to which the syringe is releasably mounted, an actuation member movably coupled to the base, a pusher that is movably coupled to the base and arranged for engaging the syringe plunger, and a drive assembly, the actuation member being repeatably movable from a start position to a preset fully advanced position, the pusher being coupled to the actuation member through the drive assembly such that when the syringe has been primed by dispensing an amount (or volume) of substance from the syringe needle and the pusher is in abutment with the syringe plunger, the actuation member can be repeatedly advanced (or depressed) from the start position to the fully advanced position to repeatedly advance the syringe plunger in the syringe barrel a preset distance to deliver multiple predetermined amounts of substance from the syringe. Alternatively, to deliver multiple predetermined volumes or desired or preset amounts (or volumes) of substance from the syringe.

In one variation of the dispensing system, the syringe contains a pharmaceutical product used in the treatment of facial lines and/or wrinkles.

In another variation of the dispensing system, the actuation member is a lever that has a first portion pivotally coupled to the base.

In another variation of the dispensing system, the lever has a second portion having an end that is adjacent to the barrel.

In another variation of the dispensing system, a stop member is coupled to the base, the stop member having a portion aligned with the lever such that it stops the advancement of the lever and limits the fully advanced position thereof.

In another variation of the dispensing system, the stop member has a contact portion that the lever contacts upon full advancement of the lever, the contact portion position being adjustable such that the predetermined amount of substance to be dispensed from the syringe can be varied. Alternatively, a predetermined volume of substance to be dispensed or a desired or preset amount (or volume) of substance to be dispensed can be varied.

According to another embodiment of the invention, a handheld medical substance dispensing system comprises syringe actuation apparatus and a syringe, which has a barrel, a plunger, and a needle, and is releasably mounted to the syringe actuation apparatus, the syringe actuation apparatus has a drive assembly, a lever movably coupled to the actuation apparatus, and a pusher having a portion aligned with the plunger, each of the lever and barrel has a distal portion, the lever distal portion is adjacent to and radially spaced from the barrel distal portion, the lever being repeatably movable from a first position to a fully advanced position, the actuation apparatus further includes a travel limit device coupled thereto and aligned with the lever to limit lever travel from the first position to the fully advanced position to a preset amount, the lever and the pusher being coupled through the drive assembly such that when the lever is fully advanced from the first position to the fully advanced position where it engages the travel limit device, the drive assembly advances the pusher which then advances the plunger in the syringe when the pusher is engaged with the plunger so that multiple predetermined amounts can be dispensed from the syringe. Alternatively, so that multiple predetermined volumes or desired or preset amounts (or volumes) can be dispensed from the syringe.

In one variation of the dispensing system, the position of the travel limit device is adjustable to adjust the lever travel such that multiple and variable predetermined amounts can be dispensed from the syringe. Alternatively, multiple and variable predetermined volumes or multiple and variable desired or preset amounts (or volumes) can be dispensed from the syringe.

In another variation of the dispensing system, the lever is pivotally coupled to the actuation apparatus.

In another variation of the dispensing system, the syringe contains a pharmaceutical product used in the treatment of facial lines and/or wrinkles.

According to another embodiment of the invention, handheld syringe actuation apparatus for actuating a syringe such that a plurality of amounts (or volumes) of substance can be ejected therefrom comprises a base having a support or forming a support for supporting a syringe; an actuator having a pusher movably coupled to the base, the actuator being configured to move the pusher against a syringe plunger when a syringe having a barrel having a distal end portion and a proximal end portion and a plunger disposed in the barrel is secured (e.g., releasably secured) to the base such that the plunger can be moved a plurality of times to dispense a plurality of amounts (or volumes) of substance from the syringe.

In one variation of the apparatus for actuating a syringe, the apparatus further includes a fastener coupled to the base for fastening the syringe to the support.

In another variation of the apparatus for actuating a syringe, the actuator includes a lever having a distal free end portion and another portion pivotally coupled to the base, the lever distal free end portion being adjacent to the distal end portion of the syringe barrel.

In another variation of the apparatus for actuating a syringe, the actuator is configured such that the actuator can move the pusher against the syringe plunger a preset amount when the syringe having a plunger is secured to the base.

In another variation of the apparatus for actuating a syringe, the actuator is configured such that the actuator can move the pusher against the syringe plunger a preset amount when the syringe having a plunger is secured to the base such that a plurality of preset amounts (or volumes) of substance can be dispensed from the syringe.

In another variation of the apparatus for actuating a syringe, the actuator further includes a drive assembly and a lever pivotally coupled to the base, the pusher being coupled to the lever through the drive assembly.

In another variation of the apparatus for actuating a syringe, the lever is movable from a start position to a fully advanced position and the full extent of that movement is preset such that the pusher and plunger can be advanced to dispense a predetermined amount of substance from the syringe. Alternatively, to dispense a predetermined volume or a desired or preset amount (or volume) of substance from the syringe.

In another variation of the apparatus for actuating a syringe, a stop member is coupled to the base, the stop member having a portion aligned with the lever such that it stops the advancement of the lever at its fully advanced position.

In another variation of the apparatus for actuating a syringe, the stop member has a contact portion that the lever contacts upon full advancement of the lever, the contact portion position being adjustable such that the predetermined amount of substance to be dispensed from the syringe can be varied. Alternatively, a predetermined volume of substance to be dispensed or a desired or preset amount (or volume) of substance to be dispensed can be varied.

In another variation of the apparatus for actuating a syringe, the apparatus is configured such that it can be held in one hand of a user and operated with that hand. In one example, the syringe actuation apparatus includes a lever that is pivotally mounted to the syringe actuation apparatus mounted to the syringe actuation apparatus with its free end adjacent the distal end portion of the syringe barrel.

According to another embodiment of the invention, a handheld medical dispensing system comprises a syringe having a barrel, a plunger, and a needle; and syringe actuation apparatus to which the syringe is releasably mounted, the syringe actuation apparatus having an actuator including a pusher, which is movably coupled thereto and arranged to engage the syringe plunger, a drive assembly, which is coupled to the pusher to drive the pusher, and a lever, which is coupled to the drive assembly to actuate the drive assembly and which is pivotally coupled to the syringe actuation apparatus, each of the lever and barrel has a distal end portion, a distal end, and a proximal end portion, the lever distal end portion or distal end being adjacent to and radially spaced from the barrel distal end portion. This embodiment also can include an adjustable stop to provide a variable limit on lever movement and/or can be configured to dispense a plurality of amounts (or volumes) of substance.

According to another embodiment of the invention, a method of dispensing fluid from a syringe comprises holding a medical substance delivery system including a syringe, which has a needle, a barrel containing a medical substance, and a plunger, secured (e.g., releasably secured) to syringe actuation apparatus configured to dispense predetermined amounts (or volumes) of the substance from the syringe; penetrating the needle into the skin of a patient at one site and using the apparatus to deliver a predetermined amount (or volume) of the substance from the syringe to the patient; and penetrating the needle into the skin of the patient at another site and using the apparatus to deliver a predetermined amount (or volume) of the substance from the syringe to the patient. Alternatively, the actuation apparatus is configured to dispense desired or preset amounts (or volumes) and desired or preset amounts (or volumes) of the substance are delivered.

In one variation of the method of dispensing fluid from a syringe, the predetermined amounts (or volumes) of substance delivered at the sites are the same. Alternatively, the delivered amounts (or volumes) of substance are desired or preset amounts (or volumes) and are the same.

In another variation of the method of dispensing fluid from a syringe, the predetermined amounts (or volumes) of substance delivered at the sites are different. Alternatively, the delivered amounts (or volumes) of substance are desired or preset amounts (or volumes) and are different.

In another variation of the method of dispensing fluid from a syringe, the substance delivered from the syringe is a pharmaceutical product used in the treatment of facial lines and/or wrinkles.

In another variation of the method of dispensing fluid from a syringe, the medical substance delivery system is held and operated with only one hand.

According to another embodiment of the invention, a handheld medical dispensing system comprises a syringe having a barrel and a plunger disposed therein; and syringe actuation apparatus to which the syringe is releasably mounted, the syringe actuation apparatus including a pusher and a lever, the lever being pivotally coupled to the syringe actuation apparatus to actuate the actuation apparatus and move the pusher against the plunger to dispense substance from the syringe. This embodiment also can include that the lever has a distal end and a proximal end and the barrel has a distal end portion and a proximal end portion where the lever distal end is adjacent to and radially spaced from the barrel distal end portion, and/or it can include an adjustable stop to provide a variable limit on lever movement, and/or it can be configured to dispense a plurality of amounts (or volumes) of substance.

In one variation of the dispensing system, the syringe actuation apparatus comprises an actuator including the pusher, which is movably coupled thereto and arranged to engage the syringe plunger, a drive assembly, which is coupled to said pusher to drive the pusher, and the lever, which is coupled to the drive assembly to actuate the drive-assembly.

In another variation of the dispensing system, the actuation apparatus further includes an adjustable stop arranged to provide a variable limit on lever movement.

In another variation of the dispensing systm, the syringe includes a needle, the lever being in non-overlapping relation with the needle (e.g., throughout its full stroke) and barrel of the syringe.

According to another embodiment of the invention, handheld syringe actuation apparatus for actuating a syringe comprises a base having a support or forming a support for supporting a syringe having a barrel, which has a distal end portion, and a plunger disposed in the barrel; an actuator including a pusher and a lever, the lever being pivotally coupled to said syringe actuation apparatus to actuate the actuation apparatus and move the pusher against the plunger when the syringe is mounted (e.g., releasably mounted) to the actuation apparatus to dispense substance from the syringe when the syringe is mounted to the actuation apparatus. This embodiment also can include an adjustable stop arranged to provide a variable limit on lever movement, and/or it can be configured to dispense a plurality of amounts (or volumes) of substance and/or it can have the lever arm provided with a distal end adjacent to and radially spaced from the barrel distal end portion when the syringe is mounted to the actuation apparatus.

In one variation of the handheld syringe actuation apparatus, the pusher is movably coupled to the actuation apparatus and arranged to engage the syringe plunger when the syringe is mounted to the actuation apparatus, said actuator further includes a drive assembly, which is coupled to the pusher to drive the pusher, and the lever, which is coupled to the drive assembly to actuate the drive assembly.

Any feature or features of any embodiment or variation can be combined with any feature or features of another embodiment or variation whether preferred or not. For example, any of the embodiments or variations can have any one or combination of the following features: a syringe plunger and actuation apparatus with an actuator to move the syringe plunger more than once to dispense a plurality of amounts (or volumes) of substance; a fastener to fasten the syringe to the syringe actuation apparatus; a syringe with a needle; a syringe plunger and an actuator that includes a pusher to push the syringe plunger; an actuator that includes a drive or drive assembly coupled to a syringe plunger pusher to drive the pusher and/or plunger; an actuator that includes a lever pivotally coupled to syringe actuation apparatus to actuate a drive or drive assembly; a syringe having a barrel and a lever having a distal end adjacent to and radially spaced from the distal end portion of the barrel; a lever having a distal end and a syringe having a barrel and a needle where the lever is in non-overlapping relation with the needle (e.g., throughout its full stroke); a stop member coupled to the syringe actuation apparatus and having a contact portion at a preset location to limit advancement of the lever to dispense a predetermined (or desired or preset) amount (or of volume) of substance from the syringe; a stop member coupled to the syringe actuation apparatus and having a contact portion with a adjustable position to provide variable preset stops to advancement of the lever so that a predetermined (or desired or preset) amount (or volume) of substance to be dispensed from the syringe can be varied; the position of the travel limit device is adjustable to adjust the lever travel such that multiple and variable predetermined (or desired or preset) amounts (or volumes) of substance can be dispensed from the syringe; an actuator configured to deliver a plurality of predetermined (or desired or preset) amounts (or volumes) of substance from a syringe or to deliver different predetermined (or desired or preset) amounts (or volume) of substance from a syringe; syringe actuation apparatus with a syringe mounted thereto configured so that they can be held in one hand of a user and operated or used only with that hand; a syringe containing a pharmaceutical product used in the treatment of facial lines and/or wrinkles; a reusable syringe actuation apparatus; a syringe actuation apparatus with multiple syringe supports to which the syringe is mounted or secured; a syringe actuation apparatus with a surface (e.g., a curved shaped surface) to which the syringe is mounted or secured; or actuation apparatus which a syringe is releasably mounted.

Further, a dose or a dosage can be an amount of substance.

The above is a brief description of some deficiencies in the prior art and advantages of the present invention. Other features, advantages, and embodiments of the invention will be apparent to those skilled in the art from the following description and accompanying drawings, wherein, for purposes of illustration only, specific forms of the invention are set forth in detail.

DETAILED DESCRIPTION OF THE INVENTION

Before the present invention is described, it is to be understood that this invention is not intended to be limited to particular embodiments or examples described, as such may, of course, vary. Further, when referring to the drawings like numerals indicate like elements.

According to one embodiment of the invention, a handheld medicinal or medical substance delivery system (or apparatus) comprises actuation apparatus, which can be a mechanical actuation apparatus, and a medicinal or medical dispenser (e.g., syringe) where the dispenser is mounted or coupled to the actuation apparatus such that one can manually manipulate the actuation apparatus to deliver a substance (e.g., any suitable pharmaceutical product or agent used in the treatment of facial lines and wrinkles such as a paralytic agent,) from the dispenser to a patient site or target site (e.g., muscle layer immediately beneath the skin) or to each of a plurality of patient sites or target sites, while holding the substance delivery system. The actuation apparatus can be configured to provide the operator flexibility in an amount of substance to be delivered by, for example, allowing the operator to determine the extent the actuation apparatus is actuated. For example, the operator need not fully actuate the actuation apparatus so that a smaller amount or volume of substance is dispensed. The actuation apparatus also can be configured to allow the operator to deliver a desired, preset or predetermined amount or volume of the substance. It also can be configured to facilitate repeatable delivery of the same desired, preset or predetermined amount or volume of substance, which can facilitate delivery of reproducible precise amounts or volumes of substance from the dispenser. A precise amount can, for example, correspond to a drop of liquid, where the size of the drop can depend on the density of the liquid and the surrounding pressure, or a value such as 0.1 cc of substance. In contrast, delivery of precise reproducible amounts or volumes of substance may be difficult if possible with a traditional method of holding a syringe in one hand and depressing the plunger with the other hand or the thumb of the same hand.

Further, the actuation apparatus described in the preceding paragraph can be provided with an optional adjustment mechanism to facilitate delivery of different desired, preset or predetermined amounts (or volumes) of substance or different doses or dosages.

The substance delivery system also can be configured to be held and used with a single hand (e.g., in a manner that resembles holding a pen), which can enhance controllability and stability of the system during use. Further one handed operation of the system enables its user (e.g., operator or physician) to use his/her free hand to do something else. For example, when using the system to treat wrinkles, one handed operation allows the user's free hand to hold the patient's skin and stretch the skin in the areas of wrinkles, which facilitates the proper placement of the delivered agent with the other hand. Thus, with this configuration, a single hand can be used (or only one hand is needed) to hold the agent or substance delivery system, maneuver it to the desired site, direct it to penetrate the syringe needle at the desired site, and manipulate the syringe actuation apparatus to inject a desired amount of the agent or substance into the patient. In one embodiment according to the invention that facilitates such use, actuation apparatus includes a lever actuator having one end adjacent to or radially spaced from a distal portion or the distal end of the syringe barrel and its other end coupled to the actuation apparatus. This can enhance one handed control of the device. For example, a bottom portion of the delivery system can be held in the web space of the hand between the index finger and thumb and the user's index finger used to depress the lever actuator. The lever actuator end that is adjacent to the distal portion or end of the syringe barrel can be in non-overlapping relation to the exposed portion of the needle so as not to interfere with inserting the needle into the patient. Further, the lever can be pivotally mounted to the apparatus such that the user can squeeze the lever with one hand, while holding the system with that hand to dispense substance from the dispenser. With this lever configuration the user may be able to sense back pressure and control delivery rate of the substance being dispensed. Since the lever arrangement can enhance one's ability to use the device with a single hand, it can improve its ease of use. Further, the one-handed aspect can enhance stability of the system during use.

The syringe actuation apparatus also can be configured so as to be reusable. For example, it can be configured so that the dispenser or syringe is releasably or removably mounted or coupled thereto so that, for example, a used dispenser or syringe can be replaced with a new dispenser or syringe. Further, the actuation apparatus can be configured to be coupled to an off-the-shelf medical dispenser or syringe.

According to one embodiment of the invention, a handheld medicinal or medical substance dispensing system comprises a syringe (or dispenser), which can have a barrel containing a medicinal or medical substance, releasably or removably mounted or coupled to the base or frame of actuation apparatus. The actuation apparatus includes a pusher (or slide) slidably mounted to the base or frame of the actuation apparatus and a lever that can be displaced to actuate or move the pusher. The lever can be arranged with an end located adjacent to a distal end or end portion of the syringe barrel, which can be fitted with a needle. The system can include a mechanism (e.g., a stop positioned at a preset location to limit the maximum displacement of the lever from a start position) such that when the lever is fully displaced from the start position, the lever actuates the pusher (or slide) to move the syringe plunger in the syringe barrel a specific distance, which is reproducible (e.g., when the lever is again fully displaced from its start position). In one variation, the specific distance that syringe plunger travels, which can be the same distance that the pusher travels, can be adjusted, and the adjusted distance reproducible using, for example, an adjustable mechanism to preset the adjusted maximum lever displacement. For example, the pusher and syringe plunger travel distance can be preset using an adjustable stop that provides an adjustable limit on the maximum displacement of the lever from its start position so that the preset plunger distance and dispensed substance can be varied.

This specific syringe plunger travel distance, which can be preset based on, for example, the position of the lever stop, can translate into a known and again, reproducible volume of substance or material being discharged from the syringe as described above, which can enable the user to repeatedly deliver a desired, preset or predetermined amount of substance (e.g., a fluid or paralytic agent) to, for example, the face of a patient to treat facial lines or wrinkles. The system also may be used to repeatedly deliver a dosage of the substance described above to treat facial lines or wrinkles. The dosages can be varied as well. In general, the lever, pusher, and plunger travel amount(s) or distance(s), movement amount(s), or displacement(s) can be preset e.g., through a lever stop, to dispense, deliver, eject, or inject a desired, preset or predetermined amount(s), volume(s), dose(s) or dosage(s) of substance. For example, the maximum lever displacement can be preset so that the pusher and/or plunger move a desired, preset or predetermined distance to dispense a desired, preset or predetermined amount of substance from the syringe.

Further, the system can be configured so that it can be supported by one hand, which can enhance its stability during use and the lever arrangement can enhance one's ability to use the device with a single hand and improve its ease of use.

Referring toFIGS. 1 and 2, an illustrative example of one embodiment of the invention is shown.FIG. 1is an exploded view of handheld medical substance dispensing, delivery, ejecting or injecting system100, which includes syringe200and syringe actuation and/or metering apparatus or device300.FIG. 2shows syringe200releasably or removably coupled or mounted to syringe actuation apparatus300.

Syringe200, which can be any standard hypodermic syringe having a hypodermic needle202to inject fluid (e.g., a liquid or gas) into body tissue, a barrel or tube204to which the needle is coupled, and a plunger208slidably moveable in barrel204.

Returning toFIG. 1, barrel or tube204has a distal end portion204aand a proximal end portion204b, holds fluid (e.g., any known suitable paralytic agent or dermal filler to treat facial lines or wrinkles), and has an orifice at one end for the fluid to be dispensed therefrom into needle202. Plunger208has a piston head210that fits snugly in barrel204, and thumb actuator or handle212that can be pushed to dispense fluid from the barrel and needle. The barrel can be provided with a distal tapered tip206to which the needle is attached or fined and it can be transparent so that the amount of fluid or substance therein can be monitored. Syringe barrel204can have graduated marks or indicia214a,b,e,d,e,f . . . nto indicate the volume of fluid therein. In the illustrative example, the volume between any adjacent two of these lines (e.g.,214dand214e) corresponds to 0.1 cc. The marks between these lines further indicate 0.05 cc quantities. Any suitable material can be used to make the barrel such as plastic or glass.

Although one syringe configuration is shown, any suitable syringe configuration can be used as would be apparent to one of ordinary skill in the art. For example, a syringe without a needle, but to which a needle can be fitted, e.g., a disposable needle, can be used.

Before mounting the syringe to the base, the operator or physician can perform an air removal procedure as is known in the art and tap the syringe while holding it with the needle up and then pushing the syringe plunger to dispense some liquid. Alternatively, the operator or physician can use syringe actuation apparatus300to remove air from the syringe as will be described in more detail below.

Syringe200is releasably or removably coupled or mounted to syringe actuation or metering apparatus or device300. In the illustrative example, syringe actuation apparatus300includes a base or frame302to which syringe supports304are attached. Alternatively, the frame and supports, which can be any suitable material such as plastic, can be integrally formed as a single piece construction. As shown inFIG. 7A, support304bhas a curved surface (which can, for example, be a concave or U-shaped surface) in which syringe barrel204is cradled. Support304a, which is hidden from view inFIG. 7A, has the same configuration. Although one curved surface is shown formed in support304bany other suitable surface for supporting the syringe can be used.

Syringe200can be secured to syringe actuation apparatus base302using any suitable means. In the illustrative example, straps306a,bsecure syringe barrel204to supports304a,b(see e.g.,FIGS. 2 & 7A). Since each strap is secured to a respective support in the same manner only securement of strap306bwill be described for simplification. Strap306bhas a first end306b1fixedly secured to a support304b(e.g., along a support side) and a second end306b2that is detachably secured to support304b(e.g., the other side of the support) so that the strap extends over the syringe barrel and snugly holds it against the support so as to preclude or minimize relative axial movement therebetween. Any suitable detachable securing mechanism can be used to detachably secure the second end306b2to the support. For example, hook and loop fasteners, which can be Velcro® brand hook and loop fasteners, can be used. A band of hook fasteners can be provided along one side of a strap to engage with a band of loops provided along a portion of the support. Alternatively, a band of loop fasteners can be provided along one side of a strap to engage with a band of hooks provided along a portion of the support. In one variation, both strap ends can be detachably secured to their respective support. It also should be understood that although two supports are shown, one support, two supports, more than two supports, or no supports can be used. For example, a curved surface can be formed in base302or no curved surface provided in which case a securing mechanism is still used to secure syringe200to syringe actuation apparatus300.

Syringe actuation apparatus300also includes an actuator that can move syringe plunger208toward syringe needle202to dispense or inject a plurality of desired volumes or predetermined volumes of substance. In the illustrative example, one such actuator is shown and includes pusher or pusher member308, lever or lever arm320, and a drive or drive assembly coupling pusher member308and lever arm320. A mechanism to vary the desired volumes or predetermined volumes of substance to be dispensed also can be included as will be described below with reference to the exemplary embodiment shown inFIG. 1. It should be understood, however, that although one actuator configuration will be described, other actuator configurations that can move syringe plunger208in syringe barrel204toward syringe needle202to dispense or eject a plurality of desired volumes or predetermined volumes of substance can be used as well as other mechanisms to vary the desired volume or predetermined volume of substance to be dispensed or injected into the patient.

Referring toFIGS. 1 and 7A, base302has a longitudinal channel or slot302aformed therein and in which pusher308is slidably mounted such that it can move generally parallel to plunger208of syringe200when the syringe is mounted to base302as shown in the drawings. Slot302acan extend the entire length of base302and can have a configuration that cooperates with the configuration of pusher308as shown, for example, inFIG. 7A, such that pusher308is maintained in the slot and does not fall out from base302when oriented, for example, as shown inFIG. 7A. In the illustrative example, slot302ahas a first portion302a1adjacent its opening with a first width and a second portion302a2inwardly positioned from the first portion with a second width greater than the first width. Pusher308has a corresponding first width adjacent its teeth310and second width that forms lateral extensions that mate with the wider portion of slot302aas shown inFIG. 7A. Although one slot-pusher configuration has been shown, it should be understood that other configurations or mechanisms can be used to maintain pusher308in the slot formed in base302. For example, when ratchet wheel housing314is secured to base302and secures ratchet wheel316in engagement with pusher teeth310as will be described below, ratchet wheel316can maintain pusher308in the slot formed in base302in which case pusher can have a single width. However, a slot configuration as described above can be helpful in assembly of the apparatus and avoid the need for the ratchet wheel to hold up the pusher. Housing314also can comprise separate components that are assembled around the mechanisms to be mounted therein as would be apparent to one of ordinary skill in the art. It also should be understood that housing314may have other configurations than the circular one shown. For example, housing314can be square or rectangular with one side open for attachment to base302.

Pusher teeth310extend from the bottom of pusher308and along its length to cooperate with driving gear teeth318of ratchet wheel316so that ratchet wheel316can move or drive pusher308toward plunger handle or plunger thumb actuator portion212of syringe plunger208or move pusher308and plunger portion212therewith when pusher308and plunger portion212are in engagement as shown inFIG. 3. Pusher308includes a portion or extension309that extends in a direction opposite from pusher teeth310and is arranged or aligned to engage and press against plunger handle or plunger thumb portion212of syringe plunger208. In this manner, pusher portion309advances the plunger in syringe barrel204when pusher308is moved toward the distal or needle end of syringe200. For example, inFIG. 4, apparatus300is in a state where pusher308is not advancing plunger208as system100is moved toward a patient treatment site as shown with direction arrow102a. Needle202is then penetrated though the skin “S” of a patient at treatment site as shown inFIG. 5, after which lever320is fully depressed in the direction of arrow322rotating ratchet wheel316in the direction of arrow324to advance pusher308and plunger208therewith in the direction of arrow326(FIG. 5) to inject medicinal substance into the patient. After the injection, system100can be retracted or removed from the patient as indicated with direction arrow102b(FIG. 6) without moving the ratchet wheel or plunger. This can be repeated at one or more different sites to deliver a desired amount or predetermined amount of substance to the patient at each site.

Any suitable known ratchet assembly can be used as part of the drive to rotate the drive in one direction such as a ratchet assembly having a ratchet wheel having inner ratchet teeth and outer gear teeth combined with spring loaded pawls.

Referring toFIGS. 7A and 8A-B, one drive or drive assembly using a ratchet mechanism is shown in the illustrative embodiment for purposes of example. In this example, lever arm320is coupled to pusher308through a drive or drive assembly. The illustrated drive or drive assembly includes ratchet mechanism312(see e.g.,FIG. 8A), which generally comprises ratchet wheel316, which also serves as a driving gear wheel, and pawls342a,bas will be described in more detail below. In brief lever320turns or actuates ratchet wheel316to drive pusher308toward the distal end of syringe200.

Ratchet mechanism312, which is housed in ratchet housing314(see e.g.,FIG. 8A) with axle or pin336extending therefrom to lever arm320(FIG. 7A), includes ratchet wheel316with inner ratchet teeth317extending along an inner annular surface thereof. Ratchet wheel316also has outer gear teeth318, which cooperate with pusher teeth310to drive pusher308in the direction indicated with arrow326as shown inFIG. 8Band in this manner forms a circular gear. Inner ratchet teeth317cooperate with ratchet pawls342a,b, which are pivotally coupled to or are supported on pawl support340, which is fixedly secured to pin or axle336, which extends through a center hole formed in pawl support340. Ratchet pawls342a,bare pivotally mounted to pawl support or wheel340on pins344a,b(see e.g.,FIG. 8A), which are secured to pawl support304and spring loaded with springs such that they are biased or urged toward inner teeth317to allow ratchet wheel316to rotate in only one direction (see e.g., arrow324FIG. 8B). In the illustrative embodiment, coil springs346a,bare placed in recesses in support340and arranged to bias or urge the pawls toward inner teeth317. It should be understood, however, that other spring arrangements or configurations can be used including ones without a recess or ones using other types of springs as would be apparent to one of ordinary skill in the art. Further, pawls342a,bare made to include ramp or wedge portions343a,bto assist in releasing the pawls from the ratchet wheel as will be described in more detail below. In operation, when lever320, which is fixedly secured to pin or axle336, is depressed, it moves in the direction indicated with numeral322inFIG. 5to actuate the drive assembly. That is, lever320rotates pin or axle336, which is fixedly secured to and rotates pawl support340, which rotates pawls342a,btherewith. As pawls342a,bmove with rotating pawl support340, they push the ratchet teeth317with which they are engaged and biased against to rotate ratchet wheel316in the direction indicated with arrow324as shown inFIG. 8B. As ratchet wheel316rotates in this direction with its teeth318mating with pusher teeth310, it drives or moves pusher308in the direction of arrow326so that pusher extension or arm309can engage and advance syringe plunger208to dispense fluid. When lever320is allowed to return to its start or rest position as shown, for example, inFIG. 6(e.g., by releasing lever arm320), lever arm spring334, which can be a coil spring, moves toward its rest position and lifts or moves lever arm320in the direction indicated with arrow327(FIG. 6) to its start or rest position. In the example shown inFIGS. 1-7A, spring334, which urges lever320toward its start or rest position, has one end334asecured to post335, which extends from base302, and its other end334bsecured to lever arm320. In this manner, spring335can maintain lever arm in its start or rest position when the lever arm is not being depressed. Other mechanisms also can be used to urge lever arm320toward its start or rest position as would be apparent to those skilled in the art.

As lever arm320returns to its start or rest position, it rotates pawl support340through pin or axle336in the opposite direction. As pawl support340rotates in that opposite direction, pawls342a,bslide over consecutive ratchet wheel teeth317, which in the illustrative example, are shown with an asymmetrical configuration where each tooth has a steeper slope on one side as compared to the other. It should be understood, however, that other ratchet teeth configurations can be used as well. Lever arm320can again be actuated to further advance ratchet wheel316and pusher308and this repeated as desired as diagrammatically shown inFIG. 8C.

Although one drive or drive assembly has been shown, it should be understood that many other drives or drive assemblies can be used as would be apparent to one of ordinary skill in the art and that the illustrative example is not intended to limit the scope of the invention.

Referring toFIG. 8D, release of Pawls342a,bto reset pusher308is shown. When the pawls are moved radially inward as shown and as will be described in detail below, the user can push pusher308back as generally indicated with arrow360turning released ratchet wheel in the direction indicated with arrow362. In this manner, the user can reset pusher308to a desired position (e.g., back to its position shown inFIG. 2to ready apparatus300for another syringe loaded with the desired agent or substance after syringe200has been removed).

Regarding the coupling of lever arm320to ratchet wheel316, lever arm end320bis fixedly secured to axle336or in a recess formed in axle336using any suitable means and pin or axle336is fixedly secured to pawl support or wheel340using any suitable means (see e.g.,FIGS. 7A and 7E). For example, glue, adhesive or welding can be used to secure lever arm320to pin or axle336and a splined connection can be provided between pin or axle336and pawl support or wheel340. Alternatively, all of those connections can be made with for example, glue, adhesive or welding. In this manner, lever arm320, which is biased toward its rest or start position (see e.g.,FIG. 4), can be depressed to move in the direction of arrow322(FIG. 5) to rotate pin336and pawl support wheel340and then released so that it moves as indicated with arrow327(FIG. 6) and returns to its start or rest position shown in (see e.g.,FIGS. 4 and 6).

Returning toFIG. 7A, pin or axel336extends through openings in sidewall314a,bof ratchet housing314. Sidewall314acan be provided with a bearing or hushing338to facilitate or enhance rotation of pin or axle336therein. Alternatively, the materials used to make the axle and sidewalls of the housing can be selected to facilitate the desired rotation of axle336in sidewall314awithout a bearing or bushing. Push button354, which will be discussed in more detail below, extends through sidewall314band provides a support in which pin or axle336can rotate. Again the materials can be selected to facilitate the desired rotation as would be apparent to one of ordinary skill in the art.

Referring toFIG. 7B, ratchet housing314has a cutaway portion that exposes sidewall edges315a,bso that they can be fixedly secured to base302as shown inFIG. 7A.

Since ratchet wheel316is supported by pawls342a,b, which are mounted on pawl support340, which is mounted on pin336, which is mounted in housing314, which is secured to base302, ratchet wheel316is supported in housing314in engagement with pusher teeth310. Alternatively, a ratchet wheel holding mechanism can be used to maintain the ratchet wheel in the desired position as shown inFIG. 7A. In this arrangement, ratchet wheel holding mechanism319comprises a disk319ahaving an outer portion319a1fixedly secured to ratchet wheel316, an inner portion319a2aligned with pawl wheel340and not secured thereto so as to allow relative movement between inner portion319a2and pawl wheel340, and cylindrical hub319bthat is rotatably mounted on axle336and from which disk inner portion319a2extends. Inner portion319a2also is rotatably mounted to axle336, which extends through a central opening in inner portion319a2. Inner portion319a2also can be recessed so as to be spaced from pawl wheel340. Further, holding mechanism319can be formed as a single unitary element and can comprise any suitable material such as plastic.

As discussed above, lever arm320can be configured and/or arranged to facilitate one handed use of the system. In the illustrative embodiment, lever arm320has a distal end or free end320a(FIGS. 1-6), a proximal end320b(FIG. 7E), and a portion321(FIGS. 1-6), which can be used to push, actuate or depress lever arm320in the direction of arrow322(see e.g.,FIG. 5). Portion321can be angled to extend generally parallel to the longitudinal axis of syringe barrel204or syringe needle202when the syringe is mounted to syringe actuating apparatus300. The position of portion321adjacent to the distal end portion of syringe barrel204and its depicted configuration can enhance the ease in which a finger can depress lever320. However, other configurations can be used. Lever arm distal end or free end320ais arranged to move alongside barrel204. It also is adjacent to the distal end portion of syringe barrel204and in non-overlapping relation with needle202so as not to interfere with placement of the needle in the patient as shown, for example, inFIGS. 4 and 5where the lever arm is shown in non-overlapping relation with needle202throughout a full stroke.FIG. 7Aillustrates this non-overlapping relation as the lever arm320moves within a plane as illustrated by380which is laterally offset from the axis of the needle (which is aligned with the plunger208). Lever free end320aor the distal free end portion of lever320also can be radially spaced from barrel204as shown inFIG. 7A. for supporting the syringe can be used.

In the embodiment shown inFIGS. 1-6, a mechanism is provided so that the dispensing system can deliver a desired, preset or predetermined amount or volume of substance. In one embodiment, a mechanism is provided to limit the movement or advancement of lever arm320(or limit the maximum arc or arc length that it can travel) in the direction of arrow322(see e.g.,FIG. 5). In this manner, the limiting mechanism also limits the corresponding rotation of ratchet wheel316and translation of pusher308. This limiting mechanism is arranged so that the travel distance or displacement of lever arm320, ratchet wheel316, and/or pusher308, upon full depression or actuation of lever arm320from its start position, can be preset in a manner such that a plurality of desired, preset or predetermined volumes of substance can be dispensed or ejected from syringe200. The maximum movement of lever arm320can be preset to drive to ratchet wheel316and/or pusher a preset distance. In the illustrated embodiment, a lever stop or lever travel limit device (e.g. stop or limit device328) is provided. Stop328has an arm330that extends from ratchet housing314and turns 90 degrees or any suitable amount so as to extend into the path of lever arm320. Arm330has a first portion330athat extends from housing314and a second portion330bthat extends into the path of lever arm320(see e.g.,FIG. 7C). The stop sets or defines the fully advanced position of lever320as lever320cannot travel beyond the stop. In another embodiment, the stop can be formed with a member that extends from base302and under lever320. When the stop does not have an adjustable stop member, syringe actuation apparatus300can be calibrated with syringe200or any syringe or dispenser to be used therewith using known techniques to locate where the stop will be located or preset to provide a desired, preset or predetermined amount or volume of substance to be ejected.

Referring toFIG. 1-6, stop arm330of stop328can include an optional mechanism or member to vary the maximum displacement of lever arm320or the maximum stroke or maximum distance or arc that lever arm320travels to vary the desired, preset or predetermined amount or volume to be dispensed. In the illustrative embodiment, stop arm330can be provided with an optional threaded bore in which an optional stop member or set screw332is rotatably positioned so that set screw332can be raised or lowered to change or adjust the range of movement that lever arm320can travel. Set screw332has a contact surface or portion332athat lever arm320contacts upon full advancement thereof where the contact portion position is adjustable since set screw332can be raised or lowered such that the desired, preset or predetermined amount of substance to be dispensed from the syringe can be varied. Set screw332can include any suitable means for assisting in rotating it to move it up or down such as a slot in its lower end or any other suitable mechanism as would be apparent to one of ordinary skill in the art.

Set screw332can include indicia to indicate a desired, preset or predetermined dispensing, ejecting, or injection amount or volume so that it can be positioned at a desired location or preset to provide a desired, preset or predetermined amount or volume of dispensed substance. For example, the indicia can permit the user (e.g., operator or physician) to adjust set screw332(the stop member), so that the amount or volume of dispensed substance can be varied (e.g., to eject 0.1 cc, 0.2 cc, or 0.3 cc from the syringe). These volumes can, for example, correspond to desired, preset or predetermined amounts or volumes of substance to be dispensed. Syringe actuation apparatus300can be calibrated with syringe200or any syringe or dispenser to be used therewith using known techniques to create the indicia and provide this result. For example, marker lines “1,” “2”, and “3” can be created by calibrating actuation apparatus300with syringe200so that 0.1 cc, 0.2 cc, or 0.3 cc are ejected from the syringe upon full displacement of lever arm320when set screw332is at certain levels and providing the marker lines on the set screw based on the results.

Thus, and with reference to, for example,FIGS. 2, 4 and 5, system100can be calibrated so that the position of stop member or set screw332can be preset as shown, for example, inFIG. 2 or 4so that the pusher moves the plunger a desired, preset, or predetermined distance (the pusher can move the same distance to provide this result) to provide a desired, preset or predetermined ejection or 0.1 cc of substance (e.g., fluid) from syringe200when lever320is depressed from its start position as shown, for example, inFIG. 4to a fully depressed position as shown inFIG. 5where the lever arm contacts set screw332. When set screw332is in this position, the bottom of marker line “1” is aligned with or flush with the upper surface of stop arm300(see e.g.FIG. 4). Referring toFIG. 2, when marker line “2” has been created based on a calibration to provide 0.2 cc of substance (e.g., fluid) and stop member or set screw332adjusted or lowered so that the bottom of marker line “2” is aligned or flush with the upper surface of stop arm330and lever arm320is depressed from its start position to where it contacts stop member or set screw332, 0.2 cc of substance (e.g., fluid) is dispensed from syringe200. Another marker line, e.g., marker line “3” (see e.g.FIG. 2), can be provided above marker line2such that when its bottom is aligned or flush with the upper surface of stop arm330, 0.3 cc of substance (e.g., fluid) is dispensed when lever arm320is depressed from its start position to where it contacts stop member or set screw332.

The ability to preset the maximum displacement of lever arm320, which activates pusher308to move plunger208in syringe barrel204a specific distance, which is adjustable and can be preset based on, for example, the position of lever stop member332, can translate into a known and again, reproducible, volume of substance or material being discharged from the syringe as described above, which can enable the user to repeatedly deliver desired, preset or predetermined amounts or volumes or substance (e.g. a fluid such as a paralytic agent) to a patient. This can, for example, enhance the user or operator's ability to obtain symmetry of results or to deliver the desired agent symmetrically over a region.

It is further noted that the (1) lever arm actuator or (2) lever arm stop or stop member taken individually or in combination contribute to the ergonomics of the handheld dispensing system.

Regarding the pawl release described above, one example of a pawl release mechanism for releasing the pawls to reset pusher308is diagrammatically shown, for example, inFIGS. 7D-Fand generally designated with reference numeral350. Referring toFIG. 7D, release mechanism350generally comprises push button354, open cylinder351, which the push button moves to cooperate with pawl ramp or wedge portions343a,bof pawls342a,b, and a biasing mechanism such as coil spring352that biases cylinder351away from pawls342a,b.

Push button or actuator354is a hollow tubular member having a closed end354aand an open end354b. Push button354is rotatably and slidably mounted on axle336and has a slot or window356formed therein through which lever arm320extends as diagrammatically depicted inFIG. 7E, which diagrammatically illustrates the push button and lever arm ofFIG. 7Dfrom the opposite side. The cut-out in push button354that forms slot356has an upper edge356a, a lower edge356b, and side edges356c,d.FIG. 7Fdiagrammatically shows a transverse section view of the push button and lever arm ofFIG. 7Eand the slot upper edge356aand lower edge356b. The width “w” of slot356is sized so that lever arm320can travel its intended or desired distance or stroke when depressed or released. Length “I” of slot356is sized to permit operation and sliding of push button354about lever arm320so that the push button can be pushed to release the pawls and allowed to return to its unactuated position.

Push button354also extends over axle336through an opening in ratchet housing sidewall314bas shown, for example, inFIG. 7Dwhere it engages coil spring352and can move back and forth in the sidewall opening. Coil spring352surrounds axle336and has one end abutting pawl support340and its other end abutting the annular edge face at the open end of push button354. In this manner, coil spring352biases or urges push button354toward its start position or unactuated position as shown, for example, inFIG. 7D. Open cylinder351, which can be a shallow cylinder as shown, comprises a cylindrical wall351awith an open end and annular wall portion351bat its other end. Annular wall portion351bhas a center opening through which push button354extends and is fixedly secured as indicated with reference numeral353. The fixed connection between annular wall portion351band push button354can be made with any suitable means such as welding, adhesive or glue that is applied, for example, continuously for 360 degrees or less than 360 degrees or is applied non-continuously in a spaced pattern. Spring352urges push button354away from pawl support340and through push button354spring352urges annular wall portion351bof cylinder351against housing sidewall314b. In this manner, an operator can push button354toward pawl support340to move the pawls radially inward and then release push button354so that is can return to its unactuated position shown inFIG. 7Dand as generally indicated with reference arrow358. Pawls342a,bare made to include ramp or wedge portions343a,b, which form part of pawls342a,b. Ramp or wedge portions343a,bare diagrammatically shown inFIG. 7Dwith a tapered configuration with one side sloping radially inward so that when cylinder351aengages the ramp or wedge portions, it moves pawls342a,bradially inward. The illustrated tapered configuration or sloping side that forms a ramp can extend the length of the ramp or wedge portions343a,b, which can, for example, run a short distance from the distal or free end of a respective pawl along the distal end portion of the pawl, or run from the distal or free end of the pawl close to the pivot pin, or a different distance. However, it should be understood that ramp or wedge portions343a,bcan be angled, configured and/or arranged differently than that shown to cooperate with cylinder351such that pawls342a,bare moved radially inward when cylinder351is pushed toward pawl support340and against such ramp or wedge portions as would be apparent to one of ordinary skill in the art. Other release mechanisms also can be used.

Referring toFIG. 7D, when the user wants to reset pusher308, the user pushes push button354to move the open end of cylindrical member351that faces pawl support340toward pawls342a,b. As the open end of cylindrical wall351aengages the pawl ramp or wedge portions343a,b, it pushes ramp portions343a,bor pawls342a,bradially inward about their pivot pins as diagrammatically shown inFIG. 8D. In this position, the user can reset the position of pusher308. It also should be understood that other release mechanisms can be used. After resetting pusher308, push button354can be released to allow the pawls to reengage ratchet wheel316.

The following example is set forth to illustrate one method of operation of the invention, and is not intended to limit the scope of the invention. For example, the method described hereafter will be disclosed in connection with treating facial wrinkles or lines, but is not intended to be limited to such treatment. More specifically, the following example involves injection of a liquid filler or paralytic agent in a facial line or wrinkle to paralyze selective muscles of the face in order to provide diminishment and smoothing of the line or wrinkle. The injection can be repeated to treat other lines or wrinkles or to add more liquid filler to a treated line or wrinkle.

Syringe200, which contains a paralytic agent as described above, can be primed to remove air therefrom before it is mounted to syringe actuating apparatus300as described above or syringe actuation apparatus300can be used to prepare the syringe for use. In the latter case, syringe200can be secured to syringe actuation apparatus300and the apparatus held so that syringe needle202extends upwardly. Then syringe actuation apparatus300can be actuated by pressing lever arm320(e.g., with the index finger) to advance pusher portion or arm309into contact with the syringe proximal end portion or thumb portion212of syringe plunger208if not engaged therewith (FIG. 2), and then further actuated by further depressing lever arm320to advance syringe plunger208in syringe barrel204to dispense a first small amount of substance (e.g., a drop of substance “d”) to prepare the syringe for use as shown inFIG. 3.FIG. 3shows lever arm320only partially depressed to dispense a small amount of substance.

If apparatus300has not been used to prepare the syringe for use (e.g., the syringe was prepared before securing it to syringe actuation apparatus300) or pusher extension309is not engaged with syringe thumb actuator portion212(FIG. 2), lever302is depressed to engage pusher308with thumb actuator portion212and then lever302is released to allow it to return to its start position or at rest state as shown inFIG. 4.

With handheld system100ready for use, the operator or physician holds system100in one hand with the system cradled in the web of the physician or operator's hand between the thumb and index finger and the index finger on lever portion321as generally diagrammatically shown inFIG. 9. The middle finger can provide further support for holding the apparatus300. The operator or physician uses the other hand to hold the patent's skin and stretch the skin in the areas of facial lines or wrinkles to assist in properly placing the syringe needle and delivery of the agent. The operator or physician then advances dispensing apparatus100toward a target site on the patient's skin as indicated with arrow102ainFIG. 4.

Referring toFIG. 5, after the operator or physician has penetrated the patient's skin with syringe needle202, he or she fully depresses lever arm320to engage set screw or stop member332of lever stop328to move pusher308and syringe plunger208a desired (or preset and/or predetermined distance) and inject a desired (or preset and/or predetermined) amount (or volume, dose or dosage) of a paralytic agent in the muscle beneath the facial line or wrinkle being treated.

FIG. 6shows dispensing apparatus100after syringe needle202has been withdrawn from the patient and lever arm320released and allowed to return to its start position as shown inFIG. 4. The operator or physician can then penetrate the needle into another site to treat other lines or wrinkles or to add more liquid filler to a treated line or wrinkle and this can be repeated until the syringe is emptied or no longer has a desired (or preset and/or predetermined) amount (or volume, dose or dosage) of substance or paralytic agent contained therein. Then syringe200can be removed from syringe actuation apparatus300, pusher308reset, and another syringe containing the desired paralytic agent mounted to apparatus300to continue treatment of the patient or to treat a different patient. Further, stop member or set screw332of stop328can be adjusted after any injection to change or vary the desired amount (or volume, dose, or dosage) or the desired (or preset and/or predetermined) amount (or volume, dose, or dosage) of agent to be injected at any point during a procedure.

Any feature described in any one embodiment described herein can be combined with any other feature of any other embodiment whether preferred or not.

Variations and modifications of the devices and methods disclosed herein will be readily apparent to persons skilled in the art. As such, it should be understood that the foregoing detailed description and the accompanying illustrations, are made for purposes of clarity and understanding, and are not intended to limit the scope of the invention, which is defined by the claims appended hereto.