KR20170019368A - Handheld medical substance dispensing system, apparatus and methods - Google Patents

Abstract

A variety of handheld medical distribution configurations and methods are provided, including: A hand held medical dispensing system includes a syringe having a plunger releasably mounted to a syringe actuating device having an actuator configured to move the plunger more than once to dispense a large amount of substrate from the syringe, And a housing adapted for one-hand administration of infusion liquid. A method of dispensing fluid from a syringe includes the steps of holding a drug delivery system having a needle and a syringe secured to a syringe actuating device configured to dispense a predetermined basis mass from the syringe, Using the device to deliver a substrate mass, and using the device to penetrate the needle at another patient location and deliver a predetermined substrate mass.

Description

[0001] HANDHELD MEDICAL SUBSTANCE DISPENSING SYSTEM, APPARATUS AND METHODS [0002]

This application is a continuation-in-part of U.S. Patent Application No. 14 / 286,701, filed May 23, 2014, which is a continuation-in-part of U.S. Patent Application No. 13 / 550,473, filed July 16, The present application is also a continuation of United States Patent Application Serial No. 14 / 481,708, filed September 9, 2014, which is a continuation-in-part of U.S. Patent Application No. 13 / 550,473, filed July 16, 2012, No. 14 / 286,701, filed on March 23,2003. All of the above-identified patent applications are incorporated herein by reference.

In the field of cosmetic surgery, non-invasive procedures have enjoyed an increase in popularity over the last decade. Most conventional procedures involve the injection of liquid fillers into the face lines and wrinkles, as well as the use of agents to paralyze the selective muscles of the face to provide reduced wrinkles and smoothness. Typically, a dermal filler or a paralytic agent such as Botox.RTM.Cosmetic (onabotulinumtoxin A) is used for outpatients. Such formulations can typically be used in a freeze-dried form in a sterile vial of the product. The clinician will reconstitute the formulation according to the specific prescription of sterile saline (liquid) added to the vial of the product. Once mixed, the pharmaceutical preparation is withdrawn into the syringe for subcutaneous delivery using a small hole in the medical needle. The most common delivery method is to use a disposable 1 cc syringe with a disposable needle inserted. Importantly, a small amount of renewable fluid allocation is delivered through multiple infusions into the facial muscles, such as the frontalis muscle of the facial area that will benefit from treatment.

In addition, the use of small syringes during infusion of a subject's face sitting in a chair is generally inconvenient to the healthcare provider, and the need to pressurize the plunger located at the rear end of the syringe assembly while trying to stably hold the syringe Are known to be exposed to unstable manipulation of the syringe. It would therefore be desirable to provide a handheld dispenser or syringe that is more stable in this application or may be a desired tiller or quantity from a handheld dispenser or syringe to provide predictable and / or desired results have.

The present invention includes improvements to drug delivery systems and can also be used for the delivery of any substrate. One such example includes a drug delivery system for the treatment of facial lines and / or wrinkles.

One variation of the device described herein includes a dispensing unit for use in a syringe. For example, such an apparatus includes a syringe having a barrel and a slidable plunger relative to the barrel for dispensing a substrate located therein, wherein the medical delivery system is configured such that the distal end of the barrel is adjacent to a distal end of the housing assembly A housing assembly configured to secure a barrel of the plunger; A drive mechanism coupled to the housing assembly and including a plunger fitting coupled with the plunger; Actuator; And a gear drive assembly coupled between the plunger fitting and the actuator, the gear drive assembly having a plunger fitting in a first direction relative to a distal end of the housing, and in a second direction opposite the first direction, To move in response to movement of the actuator.

A variation of the dispensing unit includes a gear drive assembly that moves the plunger fitting in a first direction and then in a second direction in a single stroke of the actuator. Also, in some variations, a portion of the gear drive assembly may be disengaged such that the plunger fitting moves in a second direction in a single stroke of the actuator.

As mentioned herein, the dispensing unit described herein includes at least a first gear structure configured to generate movement of a plunger fitting in a first direction, and a second gear structure configured to generate movement of the plunger fitting in a second direction And a gear drive assembly including the gear drive assembly; Wherein a movement of the actuator in the first segment causes movement of the first gear structure and movement of the actuator in the second segment causes movement of the second gear structure ≪ / RTI > In a further variation, the gear drive assembly separates the first gear structure during movement of the actuator in the second segment.

As discussed herein, variations of the distribution unit may use one or more rack and pinion gear assemblies. However, any such mechanism may be used to achieve the same result.

An example of a dispensing unit is one or more first gears that are releasably coupled to the actuator through the first axis to cause movement of the actuator to the second segment through the first segment to cause separation of the actuator from the first axis. Structure. In a further variation, the second gear structure may be detached from the actuator until the actuator moves through the first segment.

In another variation, the dispensing unit includes a syringe having a barrel and a slidable plunger relative to the barrel for dispensing a substrate located therein; A housing assembly configured to secure a barrel of the plunger such that a distal end of the barrel is adjacent a distal end of the housing assembly; A drive mechanism coupled to the housing assembly and including a plunger fitting coupled with the plunger; Actuator; And a gear drive assembly coupled to the plunger fitting and actuator, the gear drive assembly having a plunger fitting assembly in a first direction relative to a distal end of the housing, and then in a second direction opposite the first direction, To move in response to movement of the actuator.

The invention also encompasses a method for injecting a substrate into a patient. In one embodiment, the method includes positioning a syringe having a plunger coupled to a barrel and a cannula extending from the barrel adjacent a tissue location of the patient; Advancing the cannula into the operative position; And actuating a drive mechanism coupled to the syringe, wherein the drive mechanism moves the plunger and barrel in a first direction relative to each other in a single directional actuation of an actuator of the drive mechanism, In a second direction opposite to that of the first direction.

In another variation, the method may include positioning the infusion device with a reservoir having, for example, a slidable plunger therein and a cannula extending from the barrel, adjacent the tissue location of the patient, Administering an infusion; Advancing the cannula into the tissue location; And operating the lever first with one hand so that the plunger increases the volume of the reservoir and then the plunger reduces the volume of the reservoir to deliver the substrate to the patient.

Another variant of the device according to the invention comprises an apparatus for delivering an implant of a substrate into a tissue region, the apparatus comprising: a reservoir configured to hold a substrate; A plunger coupled to the reservoir such that movement of the plunger changes the volume of the reservoir; A cannula communicatively coupled to the reservoir at the distal end and configured to penetrate the tissue region; And an actuator mechanically coupled to the plunger, wherein the actuator is configured to move from a rest position to a delivery position, wherein the partial movement of the actuator from a rest position produces movement of the plunger in a first direction, Continuous movement of the actuator toward the delivery position produces movement of the plunger in the second direction, wherein the first direction is opposite to the second direction.

Any feature or feature of any embodiment or variation may be combined with any feature or feature of another embodiment or variant, regardless of preference. For example, any embodiment or variation may have one or more combinations of the features described below. An actuator having a syringe plunger and an actuator to dispense a large amount of (or a large volume of) substrate by moving the syringe plunger more than once; A fastener for securing the syringe to the syringe actuator; A syringe having a needle; An actuator including a syringe plunger and a pusher for pressing the syringe plunger; An actuator including a drive or drive assembly coupled to the syringe plunger pusher to drive the pusher and / or plunger; An actuator including a lever pivotably coupled to the syringe actuating device for actuating the drive or drive assembly; A syringe having a barrel and a lever having a distal portion adjacent to and radially spaced from the distal portion of the barrel; A syringe having a lever having a distal end and a barrel and needle in which the lever is in non-overlapping relationship (e.g., through its full stroke) with the needle; A stationary member coupled to the syringe actuating device and having a contact portion at a set position for dispensing a predetermined (or desired or set) amount of (or volumetric) substrate from the syringe by limiting advancement of the lever; An adjustable position coupled to the syringe actuating device and adapted to provide a set stop variable to the advancement of the lever such that a predetermined (or desired or set) amount of (or volume) substrate to be dispensed from the syringe can be changed, A stationary member having a contact portion with the stationary member; The position of the movement restriction device is adjustable to adjust the lever movement so that a plurality of (and optionally) predetermined and variable amounts of (or volume) of substrate can be dispensed from the syringe; An actuator configured to transfer a plurality of predetermined (or desired, or set) amounts (or volumes) of substrate from a syringe, or to deliver different predetermined (or desired or set) amounts (or volumes) ; A syringe actuator having a syringe mounted thereon, the syringe actuator being configured to be held in one hand of a user and to be operated or used only with one hand; A syringe containing a medicament for use in the treatment of facial lines and / or wrinkles; A reusable syringe actuator; A syringe actuator having a plurality of syringe supports on which the syringe is mounted or secured; A syringe actuating device having a surface on which the syringe is mounted or secured (e.g., a surface of a curved shape); Or the syringe is releasably mounted.

In addition, the dosage or dosage may be an amount of the substrate.

The present invention also includes a dispensing unit for use in a syringe and configured to allow one hand movement to deliver an injection by a user. For example, in such a system, the syringe may include a barrel and a slidable plunger relative to the barrel to dispense the substrate located therein within the canula. The dispensing unit having a drive mechanism associated therewith, the drive mechanism including an actuator for moving the gear assembly to advance the plunger fitting, and at least a plurality of recesses having a contour shape on the housing; The housing having a loading surface, a base surface, a lever-side, and a support-side; The loading surface including a window that exposes a drive assembly that permits insertion of the syringe into the housing in alignment with the longitudinal axis of the housing such that the distal end of the barrel is adjacent the distal end of the housing, The plunger of the syringe being engageable with the plunger fitting; The base surface configured to maintain the housing in a rest position when positioned on an outer surface and also to maintain stability of the housing when the syringe is coupled through the window; The plurality of recesses including a base recess located on the base surface and a support recess extending from the base recess toward the distal end of the housing along the support side; The support recess and the base recess are configured such that the distal end of the index finger engages with the actuator and is oriented toward the distal end as the index finger moves the actuator so that the user's thumb and seats of each of the dorsal webs .

The dispensing unit may further include at least one terminal recess located on the lever surface and adjacent to the loading surface, wherein the terminal recess is adapted to receive a force from the user's hand to the center of the user's hand to apply force to the housing on the opposite side of the support housing. Allows application of fingers.

In another variation, the housing of the dispensing unit may include one or more indicators positioned in at least one of the plurality of recesses to permit identification of the recesses. Such an indicator may include a tactile or visual indicator.

A further variant of the housing comprises at least one directional-force transducer that substantially traverses the longitudinal axis of the housing so that when the cannula is inserted into or removed from the patient, the user can apply a normal force to the directional- Force surface. Alternatively, or in combination, the housing of the dispensing unit may be configured to allow the user to press or pull the directional-force surface when the cannula is inserted into or removed from the patient, And a lever recess having at least one directional-force surface substantially transverse to the axis.

In another variation, the housing may further include a lever recess extending from the base recess toward the distal end of the housing along the lever-side, the lever recess having a seat on the actuator side of the housing, Allow.

A variant of the housing body may also include an index recess located on the actuator side of the housing and adjacent to the distal end, the index recess having an additional seating of the distal end of the additional finger to further stabilize the housing during movement of the actuator .

Variations of the device may include an actuating surface coupled to the actuator, which may include an indicator for identification thereof.

The housing discussed herein may be combined with any of the drive assemblies discussed herein or similar to those discussed herein.

In another variation, the invention includes a method for injecting a substrate into a patient, the method comprising positioning a syringe adjacent a tissue location of a patient, the syringe having a plunger fitting coupled to the plunger of the syringe Wherein the housing includes a loading surface, a base surface, a lever-side portion, and a support-side portion, wherein at least a plurality of recesses are formed on the housing The plurality of recesses having a base recess located at a base surface and a support recess extending from the base recess toward the distal end of the housing along the support side; And to allow the tip of the forefinger to be in engagement with the actuator and to remain oriented toward the distal end, to allow advancement of the syringe to the patient with one hand as the forefinger moves the actuator to perform the infusion, And gripping the housing with one hand so that the thumb and dorsal webs of the hand are respectively seated in the support recess and base recess.

The foregoing is a summary description of some drawbacks of 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 the accompanying drawings, and specific forms of the invention have been described in detail for purposes of illustration only. Variations of the access devices and procedures described herein include combinations of features of various embodiments or combinations of embodiments that are possible anywhere.

1 is a diagrammatic exploded view of a handheld distribution system (or apparatus) in accordance with an embodiment of the present invention.
Fig. 2 shows a side cross-sectional view of the embodiment of Fig. 1 assembled with a syringe mounted on a syringe actuator of the system of Fig. 1 and an actuator presser member spaced from the syringe plunger.
Figure 3 shows the system of Figure 2 with a lever arm partially pressed to engage the syringe plunger thumb to advance the syringe, in order to release a small amount of fluid from the syringe needle to prepare the device for use. It is schematically shown.
Figure 4 shows the lever arm being released and allowed to return to its starting or resting position, as shown in Figure 2, and after being advanced towards the target location on the patient ' s skin, .
FIG. 5 is a perspective view of an embodiment of a surgical instrument according to the present invention, in combination with a lever stop member, to fully dispense a lever arm through an operator's or a physician's needle through a patient's skin to dispense a substrate of a desired volume or setting and / 4 schematically illustrates the system of FIG.
Figure 6 schematically illustrates the system of Figure 5 after the system needle has been removed from the patient and the lever arm has been released and allowed to return to its start or rest position, as shown in Figure 4.
7A is a schematic cross-sectional view generally taken along line 7A-7A of FIG.
7B is a schematic plan view of the housing shown in FIG. 7A, showing the housing side wall edge secured to the syringe actuator device frame or base.
7C is a schematic plan view of a stopping device or assembly for the lever arm shown in FIG. 1, for example.
Figure 7d is a schematic, partially enlarged cross-sectional view of the release mechanism schematically shown in Figure 7a.
Fig. 7e schematically shows the push button and lever arm of Fig. 7d rotated 180 degrees.
Figure 7f schematically shows a cross-sectional view taken along line 7F-7F of Figure 7d.
Figure 8a schematically illustrates the ratchet mechanism shown generally in Figure 7a to advance the pusher member.
Figure 8b schematically shows the mechanism of Figure 8a, in which the ratchet wheel of Figure 8a is rotated and the pusher member is advanced.
Figure 8c schematically shows the mechanism of Figure 8b, in which the ratchet wheel of Figure 8a is further rotated and the pusher member is further advanced.
Fig. 8d schematically shows the mechanism of Fig. 8c, in which the pawl has been moved inward and the pusher member has been reset or retracted.
Figure 9 schematically illustrates one method of holding the system of Figure 2 in one hand.
Figure 10 shows an isometric view of a variant of a dispensing unit configured to create a negative pressure in a barrel or reservoir prior to delivering the contents of the substrate to the reservoir.
Figs. 11A and 11B show a front view and a rear view, respectively, of the apparatus 100 of Fig.
Figures 12a-12e illustrate an example of a gear drive assembly during movement of an actuator through a first stroke segment.
12F shows the separation of the rear drive gear mechanism.
Fig. 13 shows a bottom view of the modification shown in Fig.
14A to 14C illustrate movement of the actuator to cause advancement of the plunger fitting.
15A and 15B show another variation of the device in which the barrel moves relative to the plunger to generate a negative pressure.
Figure 16 shows another variation of a component for use in an injection system including a housing and a circuit.
Figures 17a-17e illustrate another variation of a dispensing unit with a modified housing that enhances the user's ability to manage one hand positioning and operation of the unit.
Figures 18A and 18B show an example of how the housing of Figures 17A-17E promotes one-hand operation of the injection unit.
Figures 19a-19c illustrate various aspects of other variants of the housing in which portions of the variously marked housings are intended for engagement by the user's hand or fingers.
Figure 20 illustrates another related concept including a sensing unit for use with a conventional syringe and / or injection system of the present invention.
Figure 21 illustrates another related concept including a holding unit for use in a conventional syringe and / or injection system of the present invention.

Before the present invention is described, it is to be understood that the invention is not intended to be limited to the particular embodiment (s) or example (s) described and, therefore, may vary. In the drawings, like reference numerals refer to like elements.

In accordance with one embodiment of the present invention, a handheld medical material or drug delivery system (or device) may include an actuator (which may be a mechanical actuation device) and a substrate (e.g., (E.g., any suitable medicament or medicament used to treat the same, facial lines and wrinkles) from a dispenser to a patient location or target location (e.g., a muscle layer just below the skin) or to multiple patient locations or target locations, respectively A medical or medical dispenser (e.g., a syringe) in which a dispenser is mounted or coupled to the operating device so that a person can manually manipulate the operating device. The actuating device may be configured to provide flexibility with respect to the amount of substrate to be delivered to the operator, for example, by allowing the operator to determine the degree to which the actuating device is actuated. For example, the operator does not need to operate the operating device fully so that a small amount or a small volume of substrate is dispensed. The actuating device may be configured to allow the operator to deliver a desired, set, or predetermined amount or volume of substrate. May be configured to promote repeatable delivery of a substrate of the same desired, set, or predetermined amount or volume, which may facilitate the transfer of the precise amount or volume of substrate that is reproducible from the dispenser. The exact amount can correspond, for example, to liquid release, and the size of the droplet can depend on the density and ambient pressure of the liquid, or on a value such as a substrate of 0.1 cc. In contrast, delivery of an accurately reproducible amount or volume of substrate may be difficult, if possible, by a typical method of holding the syringe in one hand and pressing the plunger in the other hand or the thumb of the same hand.

In addition, the actuators described in the preceding paragraphs may have optional adjustment mechanisms to facilitate delivery of different desired, set, or predetermined amounts (or volumes) of substrate or different dosages or dosages.

The substrate delivery system may be configured to be retained and used with one hand (e.g., in a manner similar to gripping a pen), which may enhance the controllability and stability of the system during use. In addition, one-hand operation of the system allows the user (e.g., an operator or physician) to make his or her free hand do something else. For example, when using the system to treat wrinkles, one-hand operation allows the user's free hand to grab the patient ' s skin and stretch the skin into the area of wrinkles, Promotes proper placement. Thus, by such a configuration, it is possible to have a formulation or a substrate delivery system to manipulate it to the desired location, direct it to penetrate the syringe needle at the desired location, and manipulate the syringe actuator to inject the desired amount of agent or substrate into the patient , One hand can be used (or only one hand is needed). In one embodiment according to the present invention which promotes this use, the actuating device comprises one end which is adjacent to or radially spaced from the distal or distal end of the syringe barrel, and the other end which is coupled to the actuating device And a lever actuator. This can enhance one hand control of the device. For example, the bottom portion of the delivery system is retained in the web space of the hand used to press the lever actuator between the forefinger and the thumb. The lever actuator end adjacent the distal end or end of the syringe barrel is non-overlapping with the exposed portion of the needle so as not to interfere with inserting the needle into the patient. The lever may also be pivotally mounted to the device such that the user can compress the lever with one hand while holding the system with its hand to dispense substrate from the dispenser. With this lever arrangement, the user can sense the back pressure and control the delivery rate of the substrate to be dispensed. Since the lever device can enhance the person's ability to use the device with one hand, this improves its ease of use. In addition, one handed embodiment can enhance the stability of the system during use.

The syringe actuating device may be configured to be reusable. For example, a syringe actuation device may be configured such that the dispenser or syringe may be releasably or removably mounted or coupled thereto such that, for example, the dispenser or syringe used may be replaced with a new dispenser or syringe . The actuating device may also be configured to be coupled to an in-stock medical dispenser or syringe.

According to one embodiment of the present invention, a hand held medical material or drug delivery system includes a syringe (or dispenser), which is releasably or removably mounted or coupled to a base or frame of an actuating device, As shown in FIG. The actuating device includes a pusher (or slide) slidably mounted on the base or frame of the actuating device, and a lever which can be displaced to actuate or move the pusher. The lever may be disposed at an end located adjacent a distal end or end portion of a syringe barrel into which a needle can be inserted. The system is characterized in that when the lever is fully displaced from its starting position, the lever actuates the pusher (or slide) so that the syringe plunger of the syringe barrel can be regenerated (e.g., when the lever is completely displaced from its starting position again) (E.g., a stop arranged at a set position to limit the maximum displacement of the lever from the start position) so as to move it to the distance. In one variation, the particular distance that the syringe plunger travels, which may be the same distance as the travel of the pusher, may be adjusted and the adjusted distance may be adjusted using, for example, a mechanism that is adjustable to set the adjusted maximum lever displacement And is reproducible. For example, the pusher and syringe plunger travel distance may be set using an adjustable stop to provide an adjustable limit to the maximum displacement of the lever from its start position, such that the set plunger distance and the dispensed substrate may change .

This particular syringe plunger travel distance, which may be set based, for example, on the position of the lever stop, can be converted to a known and reproducible volume of substrate or material to be discharged from the syringe, as described above, (E.g., a fluid or paralytic agent) to a face of a patient to be treated, for example, a face line or wrinkle. The system may be used to repeatedly deliver a dose of the above-described substrate to treat facial lines or wrinkles. The dosage can also be varied. Generally, the lever, pusher, and plunger movement (s) or distance (s), movement (s), or displacement (s) For example, via a lever stop, to deliver, release, or inject a dose, dose (s), or dosage of the substrate (s). For example, the maximum lever displacement may be set to move a desired, set, or predetermined distance to dispense a desired, set, or predetermined amount of substrate from the syringe by the pusher or plunger.

In addition, the system can be configured to be supported by one hand, which can enhance its stability during use, and the lever device can enhance the person's ability to use the device with one hand, And the ease of use thereof can be improved.

Referring to Figures 1 and 2, an illustrative example of an embodiment of the present invention is shown. 1 is an exploded view of a handheld drug delivery, delivery, release, or injection system 100 including a syringe 200 and a syringe actuation and / or metering device or device 300. Figure 2 illustrates a syringe 200 releasably or removably coupled to or mounted to a syringe actuating device 300. [

The syringe 200 includes a hypodermic needle 202 for injecting fluid (e.g., liquid or gas) into the body tissue, a barrel or tube 204 to which the needle is coupled, And may be any standard hypodermic syringe having a plunger 208 that is movable to the patient.

1, the barrel or tube 204 has a distal portion 204a and a proximal end portion 204b and may be fluid (e.g., any known suitable paralysis for treating facial lines or wrinkles A sextant or skin tilter) and has an orifice at one end to distribute fluid therefrom into the needle 202. The plunger 208 has a piston head 210 that is more fully inserted into the barrel 204 and a thumb actuator or handle 212 that can be pressurized to dispense fluid from the barrel and needle. The barrel may have a distal tapered tip 206 to which a needle is attached or placed, which may be transparent so that the amount of fluid or substrate therein can be observed. The syringe barrel 204 may have an eye mark or display 214a, 214b, 214c, 214d, 214e, 214f ... 214n to indicate the volume of fluid therein. In the example shown, the volume between any two adjacent lines (e. G., 214d and 214e) corresponds to 0.1 cc. The mark between these lines further indicates an amount of 0.05 cc. Any suitable material may be used to produce the barrel, such as plastic or glass.

Although one syringe arrangement is shown, any suitable syringe arrangement may be used, as would be apparent to one skilled in the art. For example, a syringe without a needle, but for which, for example, a disposable needle can be inserted, may be used.

Prior to mounting the syringe to the base, the operator or physician can perform the air removal process as known in the art and hold the syringe with the needle up and tap the syringe, then tap the syringe to dispense some liquid, . Alternatively, the operator or physician may use the syringe actuating device 300 to remove air from the syringe, as described in more detail below.

The syringe 200 is releasably or removably coupled to or mounted to a syringe operation or metering device or device 300. In the illustrated example, syringe actuating device 300 includes a base or frame 302 to which syringe support 304 is attached. Alternatively, the frame and the support, which may be any suitable material, such as plastic, may be integrally formed as a single member construction. As shown in FIG. 7A, the support 304b has a curved surface (e.g., may be concave or U-shaped) on which the syringe barrel 204 is mounted. The invisible support 304a from FIG. 7A has the same configuration. Although a single curved surface is shown on the support 304b, any other suitable surface can be used to support the syringe.

The syringe 200 may be secured to the syringe actuator base 302 using any suitable means. In the illustrative example, the strap 306a secures the syringe barrel 204 to the supports 304a, 304b (see Figures 2 and 7a). Since each strap is secured in the same manner to each support, only the fastening of strap 306b will be described for simplicity. The strap 306b may include a first (not shown) support (not shown) fixedly attached to the support 304b (along the support side) so that the strap extends over the syringe barrel and moreover retains it against the support to eliminate or minimize axial movement therebetween. An end 306b1, and a second end 306b2 detachably secured to the support 304b (or other side of the support). In order to releasably secure the second end 306b2 to the support, any suitable detachable fastening mechanism may be used. For example, hook and loop fasteners, which may be Velcro.RTM. Brand hooks and fasteners, may be used. A band of hook fasteners may be provided along one side of the strap to engage a band of loops provided along a portion of the support. Alternatively, a band of loop fasteners may be provided along one side of the strap to engage with a band of hooks provided along a portion of the backing. In one variant, the two strap ends can be releasably secured to their respective supports. In addition, although two supports are shown, it should be appreciated that one support, two supports, further supports may be used, or a support may not be used. For example, a curved surface may be formed in the base 302, or a curved surface may not be provided, in which case a locking mechanism may still be used to secure the syringe 200 to the syringe actuator 300 have.

The syringe actuating device 300 also includes an actuator capable of moving the syringe plunger 208 toward the syringe needle 202 to dispense or inject a plurality of desired volumes or substrates of a predetermined volume. In the illustrated example, one such actuator is shown and also includes a pusher or pusher member 308, a lever or lever arm 320, and a drive or drive unit that couples the pusher member 308 and lever arm 320. [ Assembly. A mechanism for altering a desired volume or a predetermined volume of the substrate to be dispensed may be included, as described below with reference to the exemplary embodiment shown in Fig. However, although one actuator configuration is described, it is also possible to dispense or release a plurality of desired volumes or volumes of a substrate, as well as other instruments for modifying the desired volume or substrate of a given volume to be dispensed or injected into the patient It should be appreciated that other actuator arrangements that can move the syringe plunger 208 of the syringe barrel 204 toward the syringe needle 202 may be used.

Referring to Figures 1 and 7a, the base 302 is configured to allow the pusher to move generally parallel to the plunger 208 of the syringe 200 when the syringe is mounted to the base 302, And has a longitudinal channel or slot 302a formed therein and to which the pusher 308 is slidably mounted. The slot 302a may extend the entire length of the base 302 and may also have a configuration that cooperates with the configuration of the pusher 308, for example, as shown in FIG. 7A, Is held in the slot and does not leave the base 302 when oriented, for example, as shown in Figure 7A. In the illustrated example, the slot 302a has a first portion 302a1 proximate to the opening with a first width, and a second width greater than the first width, And a second portion 302a2 positioned thereon. The pusher 308 has a corresponding first width adjacent its teeth 310 and a second width defining a transverse extension that engages a wider portion of the slot 302a as shown in Figure 7a. 2 width. It should be appreciated that although one slot-pressurizer configuration is shown, other configurations or mechanisms may be used to retain the pusher 308 in a slot formed in the base 302. [ The ratchet wheel housing 314 may be secured to the base 302 to retain the ratchet wheel 316 when locking the ratchet wheel 316 in engagement with the pusher teeth 310, May hold the pusher 308 in a slot formed in the base 302, in which case the pusher may have a single width. However, the slot configuration as described above may be helpful in assembling the device, and also avoids the need for the ratchet wheel to support the pusher. The housing 314 may also include a separate component that is assembled around the device to be mounted therein, as will be apparent to those skilled in the art. It should be appreciated that the housing 314 may have a different configuration than the depicted prototype. For example, the housing 314 may be rectangular or square with one side open for attachment to the base 302.

The pusher teeth 310 extend from the bottom of the pusher 308 and also allow the ratchet wheel 316 to move the pusher 308 toward the plunger handle or plunger thumb actuator portion 212 of the syringe plunger 208 The plunger portion 212 and the plunger portion 212 can be moved together so that the pusher 308 and the plunger portion 212 can move together when the pusher 308 and the plunger portion 212 are engaged as shown in FIG. Cooperates with the drive gear teeth 318 of the wheel 316. The pusher 308 includes a portion or extension 309 extending in a direction opposite to the pusher teeth 310 and is also coupled to the plunger handle or plunger thumb 212 of the syringe plunger 208 Or pressed against it. In this manner, the pusher portion 309 advances the plunger in the syringe barrel 204 as the pusher 308 is moved toward the end or needle end of the syringe 200. For example, in FIG. 4, the apparatus 300 is in a state in which the pusher 308 does not advance the plunger 208 as the system 100 moves toward the patient treatment position, as shown by the directional arrow 102a. . The needle 202 then passes through the patient's skin ("S") at the treatment position, as shown in FIG. 5, and then the lever 320 rotates the ratchet wheel 316 To push the pusher 308 and the plunger 208 together in the direction of the arrow 326 (FIG. 5) to inject the drug into the patient. After injection, the system 100 can be retracted or removed from the patient, as shown by arrow 102b (Figure 6), without moving the ratchet wheel or plunger. This may be repeated at one or more different locations to deliver the desired amount or amount of substrate to the patient at each location.

Any suitable known ratchet assembly may be used as part of the drive to rotate the drive in one direction, such as a ratchet assembly with an inner ratchet tooth in combination with a spring-loaded pawl and a ratchet wheel with outer gear teeth.

Referring to Figures 7A and 8A-8B, one drive or drive assembly using a ratchet mechanism is shown for illustrative purposes as an example. In this example, the lever arm 320 is coupled to the pusher 308 through a drive or drive assembly. The illustrated drive or drive assembly includes a ratchet mechanism 312 (see FIG. 8A), which includes a ratchet wheel 316, which generally also acts as a drive gear wheel, as will be described in greater detail below, 342b. In short, the lever 320 rotates or actuates the ratchet wheel 316 to drive the pusher 308 toward the distal end of the syringe 200.

The ratchet mechanism 312 received in the ratchet housing 314 (see FIG. 8A) with an axle or pin 336 extending therefrom to the lever arm 320 (FIG. 7A) extends along its inner annular surface And a ratchet wheel 316 having an inner ratchet tooth 317 that engages the inner ratchet teeth 317. The ratchet wheel 316 also has an external gear tooth 318 that cooperates with the pusher teeth 310 to drive the pusher 308 in the direction shown by arrow 326 as shown in Figure 8b, In this way, a circular gear is formed. The inner ratchet teeth 317 cooperate with ratchet pawls 342a and 342b which are fixedly attached to a pin or axle 336 and which extend through a pore support formed in the pawl support 340 340). ≪ / RTI > The ratchet pawls 342a and 342b are configured to allow the ratchet teeth 316 to rotate in only one direction (see arrow 324 in Figure 8b), such that they are biased or urged toward the inner teeth 317, Is pivotally mounted on a pawl support or wheel 340 on pins 344a, 344b (see Fig. 8A) that are secured to the pawl support 304 and are also loaded by springs. In the illustrated example, coil springs 346a, 346b are located in the recesses of the support 340 and are positioned to deflect or press the pawls against the inner teeth 347. However, it will be appreciated by those skilled in the art that other spring devices or configurations may be used, including without recesses or using other types of springs. In addition, the pawls 342a, 342b are fabricated to include ramps or wedge portions 343a, 343b to facilitate release of the pawl from the ratchet wheel, as described in greater detail below. In operation, when lever 320, which is fixedly secured to pin or axle 336, is pressed, it moves in the direction shown by reference numeral 322 in FIG. 5 to actuate the drive assembly. That is, the lever 320 rotates a fixed pin or axle 336 and rotates the pawl support 340 rotating the pawls 342a, 342b therewith. As the pawls 342a and 342b move with the rotating pawl support 340 they push the ratchet teeth 317 so that they engage and engage the ratchet teeth 317 in the direction shown by the arrow 324 shown in Figure 8b, Is deflected against rotating the wheel 316. As the ratchet wheel 316 rotates in this direction with its teeth 318 engaged with the pusher teeth 310, this causes the pusher extension or arm 309 to engage the syringe plunger 208 Drive or move pusher 308 in the direction of arrow 326 to advance. When the lever 320 is allowed to return to its start or rest position (e.g., by releasing the lever arm 320), as shown in Figure 6, the lever arm 320, which may be a coil spring, The spring 334 moves toward its rest position to raise or move the lever arm 320 to its starting or resting position in the direction shown by arrow 327 (Fig. 6). 1-7A, a spring 334 that urges the lever 320 toward its start or rest position has one end 334a fixed to the post 335 extending from the base 302, And the other end portion 334b fixed to the lever arm 320. As shown in Fig. In this way, when the lever arm is not pressed, the spring 335 can keep the lever arm in its starting position or rest position. As will be apparent to those skilled in the art, other mechanisms may be used to press the lever arm 320 toward its starting or resting position.

When the lever arm 320 returns to its starting or resting position, it rotates the pawl support 340 in the opposite direction through the pin or axle 336. As the pawl support 340 rotates in the opposite direction, the pawls 342a, 342b are pivoted in a continuous manner, shown in an asymmetrical configuration, with each tooth in the illustrated example having a steeper slope than the other Slides over the ratchet wheel teeth 317. However, it should be appreciated that other ratchet tooth configurations may be used. The lever arm 320 may be actuated again to further advance the ratchet wheel 316 and the pusher 308 as shown diagrammatically in Figure 8c, which is repeated as necessary.

Although one drive or drive assembly is shown, it should be appreciated that other drive or drive assembly may be used, as is apparent to one skilled in the art, and that the depicted example is not intended to limit the scope of the invention.

8D, the release of the pawls 342a, 342b for resetting the pusher 308 is shown. When the pawl is moved radially inwardly as shown and described in detail below, the user rotates the released ratchet wheel in the direction shown by arrow 362, generally in the direction of arrow 360, The pusher 308 can be pushed backward as shown. In this manner, the user may pressurize the pressurizer 308 to a desired location (e.g., to remove the syringe 200 from the syringe 200) to prepare the device 300 for the other syringe loaded with the desired formulation or substrate Reset to that position.

With regard to engaging the lever arm 320 with the ratchet wheel 316, the lever arm end 320b is fixedly secured to the axle 336 or the recess formed in the axle 336 using any suitable means, And the pin or axle 336 is fixedly secured to the pawl support or wheel 340 using any suitable means (see, e.g., Figures 7a and 7e). Glue, or welding may be used to secure the lever arm 320 to the pin or axle 336 and may include a spline 336 between the pin or axle 336 and the pawl support or wheel 340, Type connection may be provided. Alternatively, all such connections can be made, for example, by glue, adhesive, or welding. In this manner, the lever arm 320 deflected toward its rest position or start position (see FIG. 4) moves in the direction of the arrow (FIG. 5) to rotate the pin 336 and the pawl support wheel 340 And then moved as shown by the arrow 327 (FIG. 6) and released to return to its starting or resting position as shown (for example, in FIGS. 4 and 6) .

Referring to FIG. 7A, a pin or axle 336 extends through the openings in the side walls 314a, 314b of the ratchet housing 314. The side wall 314a may have a bearing or bushing 338 to facilitate or enhance the rotation of the pin or axle 336 therein. Alternatively, the material used to manufacture the axle and the side walls of the housing may be selected to facilitate desired rotation of axle 336 at side wall 314a, without bearing or bushing. The push button 354, which will be described in more detail below, extends through the side wall 314b and also provides a support on which the pin or axle 336 can rotate. In addition, the material may be selected to promote the desired rotation, as will be apparent to those skilled in the art.

Referring to Figure 7b, the ratchet housing 314 has a notch that exposes the side wall edges 315a and 315b so that the side wall edges can be fixedly fixed to the base 302, as shown in Figure 7a .

Since the ratchet wheel 316 is supported by the pawls 342a and 342b mounted on the pawl support 340 mounted on the pin 336 mounted on the housing 314 fixed to the base 302 The ratchet wheel 316 is coupled to the pusher teeth 310 and is supported on the housing 314. [ Alternatively, to keep the ratchet wheel in the desired position, as shown in FIG. 7A, a ratchet wheel retention mechanism may be used. In this arrangement, the ratchet wheel retaining mechanism 319 includes an outer portion 319a1 rigidly secured to the ratchet wheel 316 and a ratchet wheel retaining portion 319b2 to allow relative movement between the inner portion 319a2 and the pawl wheel 340, A disk 319a having an inner portion 319a2 that is aligned and not secured to the hub 340 and a cylindrical hub 319b that is rotatably mounted on the axle 336 and from which the disk inner portion 319a2 extends, ). The inner portion 319a2 is rotatably mounted to an axle 336 extending through the central opening at the inner portion 319a2. In addition, the inner portion 319a2 may be recessed so as to be spaced apart from the foil wheel 340. [ The retention mechanism 319 may also be formed as a single integral element and may also include any suitable material such as plastic.

As described above, the lever arm 320 can be configured and / or arranged to facilitate one hand use of the system. In the illustrated embodiment, the lever arm 320 includes a distal or free end 320a (FIGS. 1-6), a base end 320b (FIG. 7e), and a lever arm 320 in an arrow 322 (Fig. 1-6), which can be used to actuate or press in the direction of the substrate (see Fig. 5). The portion 321 may be angled to extend generally parallel to the longitudinal axis of the syringe barrel 204 or syringe needle 202 when the syringe is mounted to the syringe actuator 300. The location of the portion 321 adjacent the distal portion of the syringe barrel 204 and its illustrated configuration can enhance the convenience with which the finger can press the lever 320. [ However, other configurations may be used. The lever arm distal end or free end 320a is arranged to move along the barrel 204. [ This can also be achieved, for example, by the needle 202 and the needle 202, as shown in Figures 4 and 5, in which the lever arm is non-overlapping with the needle 202 throughout the entire stroke, Adjacent to the distal end portion of the syringe barrel 204 in a non-overlapping relationship. The lever free end portion 320a or the distal free end portion of the lever 320 may be spaced radially from the barrel 204 as shown in FIG. 7A.

In the embodiment shown in FIGS. 1-6, a mechanism is provided so that the dispensing system can deliver a desired, set, or predetermined amount or volume of substrate. Limiting the movement or advancement of the lever arm 320 in the direction of arrow 322 (e.g., see FIG. 5) (or limiting the maximum arc or arc length to which the lever arm may move) Is provided. In this way, the limiting mechanism also limits the rotation of the ratchet wheel 316 and the translation of the pusher 308. This limiting mechanism may be such that the movement distance or displacement of the lever arm 320, the ratchet wheel 316, and / or the pusher 308, depending on the full pressurization or movement of the lever arm 320 from its start position, A desired, set, or predetermined volume of substrate can be dispensed from or can be dispensed from the syringe 200. The maximum movement of the lever arm 320 may be set to drive the ratchet wheel 316 and / or the pusher to a predetermined distance. In the illustrated embodiment, a lever stop or lever movement restriction device (e.g., stop or restriction device 328) is provided. The stop 328 has an arm 330 extending from the ratchet housing 314 and rotating at 90 degrees or any suitable amount so as not to extend into the path of the lever arm 320. [ The arm 330 has a first portion 330a extending from the housing 314 and a second portion 330b extending into the path of the lever arm 320 (see, e.g., FIG. 7C). The stop defines or defines the fully advanced position of the lever 320 because the lever 320 can not move past the stop. In another embodiment, the stop may be formed of a member extending from the base 302 to below the lever 320. When the stop does not have an adjustable stop member, the syringe actuating device 300 can be moved to a position where the stop will be positioned or set to provide a desired, set, or substrate of the desired amount or volume, May be calibrated with the syringe 200 or any syringe or dispenser used therewith.

Referring to Figures 1-6, the stop arm 330 of the stop 328 is connected to a lever arm (not shown) to change the desired, set, or predetermined amount or volume of the lever arm 320 to be at maximum displacement or distribution 320 or an optional mechanism or member to vary the maximum stroke or maximum distance or arc over which the lever arm 320 is moved. In the illustrated embodiment, the stop arm 330 is a selective stop member or set screw 332, so that the set screw 332 can be raised or lowered to change or adjust the range of movement in which the lever arm 320 can move, May have an optional threaded bore that is rotatably positioned. Since the set screw 332 can be raised or lowered so that a desired, set, or predetermined amount of substrate of the substrate to be dispensed from the syringe can be changed, the set screw 332 can be moved And has a contact surface or portion 332a on which the lever arm 320 contacts in accordance with full advancement. The set screw 332 may comprise any suitable means for helping to rotate it up and down like a slot at its lower end, or any other suitable mechanism as would be apparent to one skilled in the art.

The set screw 332 may be a desired, set, or predetermined dispense volume or dispense volume, such as to be positioned at a desired location, or to be set to provide a desired, set, or predetermined volume or volume of dispensed substrate, A discharge amount or an ejection volume, or an indication of an injection amount or an injection volume. For example, the display may allow a user (e.g., an operator or physician) to adjust the setscrew 332 (stationary member), so that the amount or volume of dispensed substrate may vary 0.1 cc, 0.2 cc, or 0.3 cc). These volumes may correspond, for example, to a desired, set, or predetermined amount or volume of substrate to be dispensed. The syringe actuating device 300 can be calibrated with the syringe 200 or any syringe or dispenser to be used therewith using known techniques to generate an indication and also to provide such results. For example, when the set screw 332 is at a certain level and provides a marker line on the set screw based on the result, the displacement of the lever arm 320 may be 0.1 cc, 0.2 cc, or 0.3 cc The marker lines "1 "," 2 ", and "3" may be generated by correcting the actuating device 300 with the syringe 200 such that the actuators 300 are released from the syringe.

Thus, for example, referring to Figures 2, 4, and 5, the system 100 may be configured such that the lever 320 is in contact with the set screw 332 from its start position, for example, as shown in Figure 4, The position of the stop member or set screw 332 can be set, for example, as shown in Fig. 2 or 4, when the pusher is pressed to the fully pressed position as shown in Fig. 5, Set, or a predetermined distance (which the pressurizer can move the same distance to provide such a result), from the syringe 200 to a desired, set, or predetermined release or 0.1 cc substrate (or fluid ), ≪ / RTI > When the set screw 332 is in this position, the bottom of the marker line "1" aligns with or is in the same position as the top surface of the stop arm 300 (see, e.g., FIG. Referring to Figure 2, when marker line "2" is generated based on correction to provide a 0.2 cc substrate (e.g., fluid), the bottom of marker line & The stop member or set screw 332 is positioned such that the lever arm 320 is pressed from its starting position in contact with the stop member or set screw 332 When adjusted or lowered, a 0.2 cc substrate (e.g., fluid) is dispensed from the syringe 200. When the lever arm 320 is pressed from a starting position in contact with the stop member or set screw 332 when its bottom is aligned with or at the same position as the top surface of the stop arm 330, (E.g., see FIG. 2) may be provided on the marker line 2 such that a marker line (e. G., Fluid) is dispensed.

Activates the pusher 308 to move the plunger 208 of the syringe barrel 204 to a certain distance and is capable of being adjusted and set based on the position of the lever stop member 332, The ability to set the maximum displacement of the arm 320 can be converted to a known and reproducible volume of the substrate or material that is emitted from the syringe as described above which allows the user to set the desired, (E. G., A fluid such as a parasympathetic agent) to the patient repeatedly. This can, for example, enhance the ability of the user or operator to acquire symmetry of the result or deliver the desired material symmetrically to the area.

It should further be recognized that (1) lever arm actuators, either individually or in combination, or (2) lever arm stop or stop members contribute to the ergonomics of the handheld dispensing system.

With respect to the pawl release as described above, an example of a pawl release mechanism for resetting the pusher 308 by the pawl is shown schematically in Figures 7D-7F, for example, and is also generally indicated at 350 . 7D, the release mechanism 350 generally includes a push button 354, an open cylinder (not shown) that moves to cooperate with the pawl ramps or wedge portions 343a, 343b of the pawls 342a, 342b, And a biasing mechanism such as a coil spring 352 that biases the cylinder 351 away from the pawls 342a and 342b.

The push button or actuator 354 is a hollow tubular member having a closed end 354a and an open end 354b. The pushbutton 354 is rotatably and slidably mounted on the axle 336 and has a slot or window 356 formed therein with the pushbutton and lever arm of Figure 7d schematically from the opposite side As shown schematically in Figure 7E, the lever arm 320 extends through it. The cutout portion of the push button 354 forming the slot 356 has an upper edge 356a, a lower edge 356b and side edges 356c and 356d. Figure 7f diagrammatically shows a cross-sectional view of the push button and lever arm, upper edge 356a, and lower edge 356b of Figure 7e. The width ("w") of the slot 356 has a size such that when the lever arm 320 is pressed or released, the lever arm 320 can move its intended or desired distance or stroke. The length ("I") of the slot 356 is determined by a push button (not shown) relative to the lever arm 320 so that the push button can be pressed to release the pawl, 354, respectively.

The pushbutton 354 also engages with the coil spring 352 to move the ratchet housing sidewall 314b as shown in Figure 7D, for example, back and forth in the sidewall opening, over the axle 336 Extend. The coil spring 352 surrounds the axle 336 and has one end adjacent to the pawl support 340 and the other end adjacent the annular edge surface at the open end of the push button 354. [ In this manner, the coil spring 352 deflects or presses the push button 354 toward its starting or non-working position, for example, as shown in FIG. 7D. The open cylinder 351, which may be a shallow cylinder as shown, includes a cylindrical wall 351a with an open end and an annular wall 351b at the other end. The annular wall portion 351b has a central opening through which the push button 354 extends and is also fixedly fixed as indicated by reference numeral 353. The fixed connection between the annular wall portion 351b and the push button 354 may be formed by welding, adhesive, or any other adhesive, such as glue, which is continuously applied at less than 360 degrees or less than 360 degrees, or is applied discontinuously in a spaced- As appropriate. The spring 352 urges the push button 354 away from the pawl support 340 and the spring 352 is pushed through the push button 354 against the housing side wall 314b by the annular wall portion 351 of the cylinder 351 (351b). In this manner, the operator moves the pawl radially inwardly to its inoperative position shown in Figure 7d and generally as shown by reference arrow 358, and then pushes the push button 354 The push button 354 may be pressed against the pawl support 340 to release it. The pawls 342a and 342b are fabricated to include ramps or wedge portions 343a and 343b that form portions of the pawls 342a and 342b. The ramp or wedge portions 343a and 343b are configured to move radially inwardly to move the pawls 342a and 342b inwardly when the cylinder 351a engages the ramp or wedge portion, Lt; RTI ID = 0.0 > 7d < / RTI > The illustrated tapered configuration or inclined side that forms the ramp may extend to the length of the ramp or wedge portion 343a, 343b, for example, from the distal end or free end of each pawl along the distal portion of the pawl Can operate at short distances, or can operate from the distal end or free end of the paw close to the pivot pin, or can operate at different distances. However, the ramp or wedge portions 343a and 343b may be formed by pawls 342a and 342b as the cylinder 351 is pressed against the pawl support 340 and against such ramp or wedge portion, as is apparent to one skilled in the art. May be angled, configured and / or arranged to move with respect to the cylinder 351 so as to move radially inwardly. Other release mechanisms may be used.

7D, when the user wishes to reset the pusher 308, the user pushes the open end of the cylindrical member 351 facing the pawl support 340 toward the pawls 342a, 342b, Button 354 is pressed. When the open end of the cylindrical wall 351 engages with the forol ram or wedge portion 343a and 343b this causes the lamp portions 343a and 343b or the pawls 342a and 342b as shown schematically in Figure 8d And presses against the pivot pin radially inward. In this position, the user can reset the position of the pusher 308. It should be appreciated that other release mechanisms may be used. After releasing the pusher 308, the push button 354 may be released to allow the pawl to recombine with the ratchet wheel 316.

The following examples have been set forth to illustrate one way of operating the present invention and are not intended to limit the scope of the present invention. For example, the methods described hereinafter are described in connection with the treatment of facial wrinkles or lines, but are not intended to be limited to such treatment. More specifically, the following examples include the injection of a liquid filler or paralytic agent into the face line or wrinkle to paralyze the selective muscle of the face to provide reduced and smooth lines or wrinkles. The infusion may be repeated to treat other lines or wrinkles or to add more liquid tillers to the treated line or wrinkles.

The syringe 200 including the paralytic agent as described above may be ready to remove air therefrom before being mounted to the syringe actuator 300 as described above or the syringe actuator 300 Can be used to prepare the syringe for use. In the latter case, the syringe 200 can be secured to the syringe actuating device 300, which is retained to extend the syringe needle 202 upward. The syringe actuating device 300 is then moved to a position to advance the pusher portion or arm 309 which is in contact with the syringe base end portion or the thumb portion 212 of the syringe plunger 208, May be actuated (e.g., with a forefinger) by pressing the lever arm 320 and then advancing the syringe plunger 208 of the syringe barrel 204 until a small amount of the first substrate (e.g., quot; d "), and is further actuated by further urging the lever arm 320 to prepare the syringe for use as shown in Fig. Figure 3 shows a lever arm 320 that is only partially pressurized to dispense a small amount of substrate.

If the device 300 has not been used to prepare the syringe for use (e.g., if the syringe is ready before being secured to the syringe actuating device 300), or if the pressurizer extension 309 is in contact with the syringe thumb actuator portion 212 (FIG. 2), the lever 302 is pressed to engage the pusher 308 with the thumb actuator portion 212, and then the lever 302 is released and, as shown in FIG. 4, To return to its start position or rest position.

By means of the handheld system 100 ready for use, the operator or physician will generally be able to place a finger or finger on the operator ' s web between the index finger on the thumb and lever portion 321 as schematically shown in Fig. 9 Hold the system with one hand. The middle finger may provide another support for holding the device 300. [ The operator or physician grasps the patient ' s skin with the other hand and spreads the skin into the area of the face line or wrinkles to assist in proper placement of the syringe needle and delivery of the formulation. The operator or physician then advances the dispensing device 100 toward a target location on the patient's skin as shown by arrow 102a in FIG.

5, after the operator or physician has passed the syringe needle 202 through the patient's skin, the operator engages the set screw or stop member 332 of the lever stop 328 and presses the pusher 308 and the syringe The lever arm 320 may be fully depressed to move the plunger 208 to a desired distance (or set and / or a predetermined distance) so that the desired (or set and / or predetermined) Amount, or dosage) of paralytic agent is injected into the muscle under the face line or wrinkle to be treated.

Figure 6 shows the dispensing device 100 after the syringe needle 202 is retracted from the patient as shown in Figure 4 and the lever arm 320 is released and allowed to return to its starting position . The operator or physician may then treat the other line or wrinkle or penetrate the needle to another location to add more liquid filler to the treated line or wrinkle, which may result in the needle becoming empty or containing more (Or set and / or predetermined) amount (or volume, dose, or dosage) of the substrate or paralytic agent. Thereafter, the syringe 200 is removed from the syringe actuating device 300, the pressurizer 308 is reset, and the other one containing the desired paralytic agent, to continue the patient's therapy or to treat the other patient A syringe is mounted to the device 300. The stop member or set screw 332 of the stop 328 may also be configured to provide a desired amount (or volume, dosage, dose) or desired (or set and / or predetermined amount) Dose, dosage, etc.) of the dosage form of the present invention.

Figure 10 shows another variation of the dispensing unit 100 configured to create negative pressure in the barrel or reservoir 204 prior to delivering the contents of the substrate to the reservoir. The illustrated variant is shown as having an inner mechanism of the device 100 without any outer covers or housings for the sake of clarity. However, any number of covers, shells, ergonomic fittings, etc. may be provided in the illustrative apparatus shown. As described below, many variations of the device include a cover that allows the medical caregiver to manage the device using one hand. In addition, additional features may be incorporated into the dispensing unit, such as the need for a feedback sensor or syringe, or other circuitry that may allow the supply of current through the needle and / or electrodes coupled to the syringe.

As shown, the dispensing unit 200 includes a syringe 200 coupled to the apparatus 100. In the illustrated example, the syringe 200 is releasably coupled to the dispensing unit 100 via one or more coupling or locking mechanisms 304, 306. Any number of fixing mechanisms may be used for the unit 100. [ Alternate variations of the dispensing unit 100 may also include a syringe built into or integrated with the dispensing unit.

The apparatus 100 shown in Figure 10 includes a first shaft 234 and a second shaft 238 (the second gear and the second shaft are located inside the guide member 240 in Figure 10) And an actuator 230 mechanically coupled to the first gear 232 and the second gear 236 through the first gear 232 and the second gear 236. A further variation of the device 100 allows the device to be held using the thumb and middle finger while the caregiver uses the index finger to actuate the actuator 320. [ The housing (not shown) may thus be configured to be conductive for such handling. Moreover, in many variations of the device 100, the actuator 230 extends toward the dispensing end (e.g., toward the cannula / needle 202 of the device). This configuration provides the user with the ability to grip the body or device with his forefinger and middle finger to operate the lever 230 with his forefinger. Clearly, there are other retention arrangements within the scope of alternative variations of the apparatus of the present invention. However, the stability of the device (when inserted into the tissue) increases as the index finger applies pressure to the lever 230, and the contact point 231 moves through a call or path that is close to where the operator holds the unit.

Figure 10 also shows the plunger 208 of the syringe 200 coupled to the plunger fitting 242 coupling the plunger 208 to the lever via a gearing system. The plunger fitting 242 thus moves the plunger in response to activation of the gear drive assembly triggered by the actuator 230. As shown, the plunger fitting 242 may include various keys and channels 242 to allow smooth advancement of the plunger 208.

The gear of this embodiment is a rack-and-pinion gear having a first rack gear 250 for moving the plunger 208 in the forward direction and a second rack gear 252 for moving the plunger 208 in the rearward direction. .

Figs. 11A and 11B show a front view and a rear view, respectively, of the apparatus 100 of Fig. The lever 230 and the guide member 240 (not shown) may also be configured to be movable in the direction of the lever 230 so as to better illustrate the drive mechanism of the illustrated variant in which the drive mechanism causes movement of the plunger when the lever actuator 230 is moved. 11a and 11b. As shown in FIG. 11A, the first drive gear 232 engages with the first rack gear 250. The first driving gear 232 rotates in response to the rotation of the first shaft 232. 11B shows the opposite end of the first axis 232 coupled to the drive lever 244. The illustrated variant also includes a rear drive gear 238 fixed to the rear drive shaft 236. The rear drive shaft 238 moves during rotation of the rear drive pulley 254.

A variation of the apparatus allows movement of the plunger 208 in a first direction using a single stroke of the lever 230, and then in a second direction. Typically, this dual directional movement allows a medical caregiver to insert the needle into the patient and then operate the device 100, such that a negative pressure is generated in the reservoir, which may cause blood or other fluids to enter the device 100 Into the reservoir or window (203). In some cases, as described above, the medical caregiver attempts to locate the needle in the muscle or other tissue, but not in the blood vessel. If the caregiver determines that the needle is preferably positioned through such a check stroke, the caregiver can continue to administer the infusion using the delivery stroke. One advantage of performing this double action in a single stroke is that the needle 202 can still be retained. This reduces the risk that the needle may inadvertently move and the injection may be delivered to undesired areas of the body.

11B illustrates an example in which the stroke of the lever 230 may include one or more segments 110,112 to allow for the reverse direction of the plunger 208. [ It should be appreciated that the lengths of the segments 110 and 112 can be adjusted as desired and that the segment length shown is for illustrative purposes only.

Figs. 12A-12E illustrate examples of gear drive assemblies during movement of actuator 230 via first stroke segment 110. Figs. 12A shows the rest position or initial position of the lever 230. Fig. As with system 100 and / or other components of the drive assembly, it should be appreciated that the lever may be spring biased to allow the gear / actuator / back to return to the initial position. Continuous movement of the lever 230 in the direction 150 causes the rear drive lever 248 to rotate the rear drive pulley 254 in the direction 152, as shown in FIG. 12B. The rear drive pulley 254 is coupled to the rear drive shaft 238 (shown in FIG. 11A) to rotate the rear drive gear 236 to move the plunger coupling 242 backward in the direction 154 . In the example shown, the rear portion 231 of the lever 230 is not yet engaged with the main drive lever 244. Once the rear portion 231 of the lever 230 is engaged with the main drive lever 244, the main drive lever 244 and the rear portion of the lever 231 move in the direction 156. However, the main drive shaft 234 may use a unidirectional clutch so that movement in the direction 156 of the main drive lever 244 does not create movement of the main gear drive 232. This clutch is required because the backward movement of the plunger attachment portion 242 causes backward movement of the main rack gear 250.

12D shows the continuous movement of the lever 230 and the rotation of the rear drive gear 236 and the rear drive shaft 238 in order to continue the movement of the plunger coupling 242 in the backward direction 154. [ . FIG. 12E shows a state in which the movement 150 of the lever 230 reaches the second segment 112. FIG. In this state, the movement 150 of the lever 230 into the second segment 112 causes the rear drive surface 246 of the rear drive lever 248 to move rearwardly of the rear drive pulley 254 ). In the illustrated example, the slot 256 located in the rear drive lever 248 allows movement of the rear drive surface 246 away from the rear drive pulley 254. However, any number of configurations (such as cam / follower design, contour, etc.) may be used to prevent movement of the rear drive pulley 254. 12E, the movement of the lever 230 through the segment 112 causes continuous movement in the direction 156 of the main drive lever 244 and the direction 162 of the first or the main gear 232 (As shown in FIG. 11A) when the main gear 232 is engaged with the first rear rack gear 240 by causing rotation of the plunger coupling 242, as shown in FIG.

Continuous movement of the lever 230 through the second segment 112 causes movement of the first gear 232 and the first axis 234 such that the forward movement of the plunger fitting and plunger ultimately causes the movement of the plunger, So as to prevent the backward movement of the plunger fitting. Also, the position of the lever 230 is provided for illustrative purposes only, and the arc lengths of the first and second segments 110, 112 can be adjusted based on the amount of negative pressure and the amount of fluid delivery required. Furthermore, as required to obtain the desired displacement or movement of the plunger fitting, the gear engagement ratio can be adjusted.

In the sequence described above, the first segment 110 corresponds to a check, and the second segment corresponds to the transfer of a substrate. Obviously, if the caregiver observes the presence of blood (or any other negative condition), the caregiver releases the actuator 230, and if the caregiver injects the matrix and avoids the muscles, Return to the rest position or the initial position. Alternatively, the infusion system may be used to confirm substrate delivery into the blood vessel, where a check is used to confirm placement of the needle in the vessel. The present invention includes any number of permutations of use of the system to allow movement of the plunger in two directions with minimal movement of the needle and / or with a single stroke of the actuator.

Fig. 13 shows a bottom view of the modification shown in Fig. The illustrated illustration shows an optional lockout feature 258 having one or more surfaces 260 that can engage a portion of a rear drive lever 248 (in this example, The portion 258 engages one or more pins 262 of the rear drive lever 248). In the example shown, the locking feature 258 can be advanced in the direction 158 to engage the rear drive lever 248 and separate the device from the performance of the check feature.

Figs. 14A-14C illustrate movement of the actuator 230 to cause advancement of the plunger fitting 242. Fig. The illustrated example shows the device when the separation feature 258 has disengaged the rear drive lever 248 from the rear drive pulley 254. However, when the rear drive arm 248 is disengaged from the rear drive pulley 254, the same principle applies when the actuator 230 enters the second travel segment 112 as described above.

14A shows the device 100 in which the lever 230 is in the resting or initial position and can be moved in the direction 164. 14B, when the lever 230 moves through the direction 164, a portion of the actuator engages the lever arm 248 to move the lever arm in the direction 156. As shown in FIG. The main gear 232 moves in the direction 162 to move the plunger fitting 242 in the direction 160 because there is no reverse movement caused by the rear drive pulley 236. [ And the main rack gear 252 of the rack gear 252. As shown, this also causes the plunger 208 to move. 14C shows the actuator 230 at the end of the stroke. Again, the position of the actuator 230 relative to the rest of the device 100 may vary as needed. Some variations of the present invention 100 include one or more springs 266 that allow the main lever 230 to return to the initial position shown in Figure 14A upon removal of the force applied to the lever 230 And a spring reset feature provided by the spring reset feature. In addition, the spring reset feature returns the lever arms 248, 244 to their rest position. In the illustrated example, the spring 266 causes movement of the actuator 230 in the direction 166 such that the slot feature restores the rear drive lever 248 and also causes a second spring (not shown) This helps to move the lever 244 in the direction 168.

The present invention contemplates any number of variations and modifications of the apparatus shown herein that permit double movement of the plunger when delivering a substrate. For example, FIG. 15A shows that actuator 230 can move barrel 204 in a direction (not shown) while holding the plunger 208 in a steady state such that this relative movement creates a negative pressure in barrel 204 170, respectively. Figures 15A and 15B illustrate how the plunger advances the barrel 204 during the initial movement of the lever 230 while maintaining the barrel 204 to advance the plunger in the direction 160 to dispense the contents of the syringe 204, Lt; RTI ID = 0.0 > 270, < / RTI >

16 depicts another variation of a component for use in the injection system described herein, and as shown the unit 100 may include any type of outer lid 280 or, alternatively, And a housing. For illustrative purposes, the housing 280 is shown without an upper lid. The housing 280 may also include any power source, electrical contact, memory, or any number of electrodes disposed on the cannula 202 and / or on the cannula 202 and / (Such as that shown at 282) that can perform sensing through the microprocessors 286, 288. The circuit 282 may be coupled to the needle / electrode 284 using any conventional conductive member 284.

17A shows a perspective view of another example of a dispensing unit 100 having a modified housing 420 that improves the ability of the user to manage one hand positioning and operation of the unit 100. [ The illustrated example also shows a plunger 208 that is slidable relative to the barrel 204 of the syringe 200 located in the housing 420.

The housing 420 includes one of any number of variations of a drive mechanism and / or a gear assembly as discussed herein, and the drive mechanism and / or gear assembly (as shown in Figure 17B) And an actuator 320 that moves the drive mechanism as discussed herein to advance the plunger fitting coupled to the plunger 208 of the unit.

As discussed below, the housing shown in FIG. 17A is designed with many features that improve the ability of the medical caregiver to enable metered injection.

Figure 17B shows a top view of the unit 100 of Figure 17A. As shown, the gear assembly and syringe of the unit may be positioned within the window 424 of the housing 420. In the variant shown, the window 424 is exposed along an upper loading surface 422 that allows loading of the syringe 200 into the gear assembly. In the variant shown, the loading surface 422 and the window 424 have sufficient room to position the syringe 200 within the housing so that the syringe and plunger can be coupled to the proper part of the instrument. . In the variant shown, the window 424 is configured so that the distal end of the barrel 204 is adjacent to the distal end of the housing, and the cannula / needle extends beyond the distal end of the housing, Thereby aligning and exposing a drive assembly that allows insertion of the syringe into the housing. The window 424 also allows the user to engage the plunger of the syringe with the plunger fitting on the gear assembly. Although not shown, the window may be closed by one or more covers.

17C shows a bottom view of the housing 420 to illustrate the bottom base surface 426 of the housing in a stationary, stationary position when exposed on the outer surface. The base surface 426 allows the user to maintain the stability of the housing when the syringe is connected to or otherwise coupled to the unit through the window 424 on the loading surface 422.

Figure 17d shows a side view of the housing 420 of Figure 17a and also shows the support side 430 of the housing 420 as well as a number of recesses that help one hand move the device. For example, the housing 420 includes at least a base recess 432 located on the base surface 426. As will be discussed below, the base recess 432 allows seating of the back web of the user's hand therein. The base recess 432 also has a directional feature that alleviates the force or force required to allow the application of force in the direction of injection [towards the needle 202] and thus advance the needle 202 to the target position A force surface 434 may be included. Without the directional force surface 434, the user must increase the compressive force on the housing through the user's finger to drive the needle into the tissue.

Figure 17d also shows the support recess 436 in which the support recess 436 is located on the support surface 430 that receives the thumb of the user's hand. 17E shows the opposite side view of the device showing lever side 228 with lever recess 438 extending from base 426 of body 420 to the distal end. The lever recess 438 allows the user's forefinger or middle finger to include / control the device with one hand when the user actuates the lever 320. In addition, the lever recess 438 helps keep the index finger in a relatively straight line. The body 420 may further include a distal or forefinger recess 440 located on the lever side 428 and adjacent the loading surface 422. The distal / forefinger recess 438 allows the seat of the user's middle finger to balance the body 420 when the user's forefinger engages the actuator 320. The support recess 436 and the base recess 432 allow seating of the body 420 on the back web of the user's hand and the end recess 440 allows the user to engage the body 420, To retain the force on the lever side 428 of the handle.

Figs. 18A and 18B show an example of how the housing 420 of Figs. 17A-17E facilitates one-hand operation of the injection unit. The user can position the base recess 432 with the web 4 of the user's hand 2 while extending the thumb 6 along the support recess 434. [ As described above, the base recess 26 also includes a distal force surface (not shown in Figures 18a or 18b). The user's hand (particularly the area adjacent to the palm or thumb's heel) can be used to apply a force in the direction of the needle or a distal force to drive the needle into tissue. Such a surface reduces the need for the user to apply an increased compressive force on the side of the housing to drive it forward. Figure 18b shows the lever side 428 of the housing 420 and the middle finger of the user's hand 2 is on the lever side and engages with the terminal recess 440 adjacent the loading surface 422. The terminal recess 440 allows the user to apply a stable force on the side of the device opposite the thumb using the middle finger 10. As shown, the forefinger 8 engages the actuator 320 to activate the device. Figure 18b shows the base surface 426 on the two sides of the base recess 432, which provides additional surface area for the user to support the housing through the use of the remaining finger 12 at the distal end of the device, ).

As described above, the configuration of the housing 402 allows the unit to be held and used with one hand (e.g., in a manner similar to gripping a pen or with the thumb and first two fingers in the forward direction End direction). Having the device using such positioning can enhance the controllability and stability of the system during use. In addition, one-hand operation of the system allows the user (for example, an operator or a doctor) to do other things with his or her free hand. For example, when using the system to treat wrinkles, one-hand operation allows the user's free hand to grab the patient ' s skin and expose the skin to the area of wrinkles, Promote placement. The illustrated housing arrangement also provides an oriented surface for improved operation to a desired location and also provides improved penetration of the needle into the tissue.

Figures 19a-19c illustrate various aspects of another variation of the housing 420, wherein the marked portions of the housing are intended for engagement by the user's hand or finger. For example, FIG. 19A shows lever 320 and terminal recess 440 as marked in a visually apparent manner or through a tactile sense. Figures 19b and 19c illustrate examples where the terminal recess 440 and the support recess 436 are marked and / or identified.

Figure 20 illustrates another related concept that may be used in the infusion system described herein or may be used as an independent improvement to a conventional infusion device that provides the caregiver with the ability to determine the type of tissue prior to infusion. As shown, the sensing fitting 380 may include a hub 382 that receives a syringe, fitting, luer, etc., commercially available at the opening 383. The hub 382 may include a conductive cannula 384 and / or one or more electrodes 386, 388. The cannula 384 (and / or the electrode) may be coupled to the fitting 390 shown as being on the hub 382 of the device 380 And the fitting permits coupling with the power supply / processor / user interface unit / 394 of the sensing fitting 380 and the like. The unit 394 may include any number of user feedback signals such as audible, visual, graphic display, Once inserted into the tissue, the unit 394 can identify whether the caregiver has placed the needle on skin, muscle, fat, blood vessels, and the like. As described above, the needle can be used in either a unipolar mode (where the ground electrode 396 is required) or in a bipolar mode in which either of the two electrodes is combined with the needle or the two electrodes are used alone .

The sensing unit 380 can be used when the caregiver has to distribute the infusion fluid into any tissue (e.g., blood vessel, skin, fat, muscle, etc.). Conductive needles 384 (and / or electrodes) may provide current to identify the type of tissue through any known mode of identifying such tissue.

Figure 21 shows another embodiment for use with the injection system described herein, or in any self-contained injection system. Figure 21 shows a holding unit 400 having a receiving area 402 of any type of commonly used vial 402 containing a medicament. The loading unit 400 includes one or more ports 406 for inserting a needle to withdraw a substrate into a syringe of an injector (not shown). The holding unit 400 is typically coupled to a power supply (AC or DC power supply) that allows the holding unit 400 to maintain the drug / substrate 404 at a desired temperature. Alternatively, the holding unit 400 may include a substrate (dry-ice, freon, ice, cold water, hot water, etc.) that can be used to heat or cool the substrate 404 without requiring any power supply 410 ).

Thus, the holding unit 400 may include a user interface 408 that provides audible, visual, and / or graphical information about the temperature of the substrate, as well as additional information such as the time, location, type, The dispensing unit 400 may be attached to a wall, a cart, a table, or the like. An alternative variant includes a portable desktop configuration.

In one example, the dispensing unit shown in Figure 18 may be used to administer Botox, Xeomin, or any similar substrate. These substrates are typically reconstituted from the lipophilic state of the dry. Once reconstituted, these substrates diminish their efficacy in proportion to their temperature over time. Standard practice involves storing the reconstituted Botox at a standard temperature of < RTI ID = 0.0 > 35 F < / RTI > The holding unit 400 can prevent the user from coming to the freezer / refrigerator / freezer / fridge when they are administered. Instead, the holding unit 400 can maintain the vial at the desired temperature, allowing the caregiver to repeatedly access the substrate to manage the injection.

Another additional benefit of the holding unit is that the caregiver can load the syringe without holding the vial 404 because the vial is temporarily secured in the holding unit 400. [

Any feature described in any one embodiment described herein may be combined with other features of any other embodiment, regardless of whether or not it is desirable.

Modifications and variations of the devices and methods described herein will be readily apparent to those skilled in the art. It is therefore to be understood that the foregoing detailed description and accompanying drawings are provided for the purpose of clarity and understanding, and are not intended to limit the scope of the invention as defined by the claims appended hereto.

Although the method and apparatus of the present invention has been described with reference to the above embodiments, many modifications and / or additions to the above described preferred embodiments will be readily apparent to those skilled in the art. It is intended that the scope of the invention extends to all such modifications and / or additions and that the scope of the invention is limited only by the claims of the invention.

Claims (55)

A dispensing unit for use in a syringe having a barrel and a slidable plunger relative to the barrel for dispensing a substrate located therein,
A housing assembly configured to secure a barrel of the plunger such that a distal end of the barrel is adjacent a distal end of the housing assembly;
A driving mechanism coupled to the housing assembly and including a plunger fitting coupled with the plunger;
Actuator; And
And a gear drive assembly coupled between the plunger fitting and the actuator,
Wherein the gear drive assembly is configured to move in response to movement of the actuator to create movement of the plunger fitting in a backward direction with respect to a distal end of the housing and then in a forward direction opposite to the backward direction, Wherein the movement of the actuator in one continuous direction produces movement of the plunger in the backward and forward directions. The method according to claim 1,
Wherein the gear drive assembly moves the plunger fitting in a backward direction and then in a forward direction within a single stroke of the actuator. The method according to claim 1,
Wherein a portion of the gear drive assembly is disengaged such that the plunger fitting moves in a forward direction with a single stroke of the actuator. The method according to claim 1,
Wherein the gear drive assembly includes at least one first gear structure configured to generate movement of the plunger in a backward direction and a second gear structure configured to create movement of the plunger fitting in the forward direction,
Wherein movement of the actuator in the first segment causes movement of the first gear structure and movement of the actuator in the second segment causes movement of the actuator in the first segment, 2 A distribution unit that causes movement of the gear structure. The method of claim 4,
Wherein the gear drive assembly separates the first gear structure during movement of the actuator in the second segment. The method of claim 4,
Wherein the first gear structure comprises a rack and pinion assembly. The method of claim 4,
And the second gear structure comprises a rack and pinion assembly. The method of claim 4,
Wherein the first gear structure is releasably coupled to the actuator via a first axis such that movement of the actuator through the first segment to the second segment causes separation of the actuator and the first shaft, . The method of claim 4,
Wherein the second gear structure is separate from the actuator until the actuator moves through the first segment. The method of claim 4,
And the second gear structure is coupled to the actuator via a second axis. The method according to claim 1,
Wherein the actuator is coupled to a first shaft rotatable relative to the housing assembly and a portion of the first shaft is coupled to the gear drive assembly. The method of claim 11,
Wherein the first axis is located proximate the barrel. As a dispensing unit:
A syringe having a barrel and a slidable plunger relative to the barrel for dispensing a substrate located therein;
A housing assembly configured to secure a barrel of the plunger such that a distal end of the barrel is adjacent a distal end of the housing assembly;
A driving mechanism coupled to the housing assembly and including a plunger fitting coupled with the plunger;
Actuator; And
And a gear drive assembly coupled to the plunger fitting and the actuator,
Wherein the gear drive assembly is configured to move in response to movement of the actuator to create movement of the plunger fitting in an anterior direction relative to a distal end of the housing and then in a forward direction opposite the backward direction, Wherein movement of the plunger fitting in the backward and forward directions occurs during movement in a single direction of the actuator. A method for injecting a substrate into a patient comprising:
Positioning a syringe having a plunger coupled to the barrel and a cannula extending from the barrel adjacent the tissue location of the patient;
Advancing the cannula into the operative position; And
Actuating a drive mechanism coupled to the syringe,
Wherein the drive mechanism is configured to move the plunger and barrel in a first direction relative to each other and subsequently in a second direction opposite to the first direction when operating in a single direction of the actuator of the drive mechanism, Way. 15. The method of claim 14,
Further comprising separating a first portion of the drive mechanism to prevent movement of the plunger in a first direction during a single actuation of the drive mechanism. 15. The method of claim 14,
Partially engaging the second portion of the drive gear through unidirectional actuation of the actuator such that the second portion of the drive mechanism moves the plunger and the barrel in a second direction relative to each other ≪ / RTI > 15. The method of claim 14,
Wherein the actuation of the drive mechanism in a single direction includes a first segment and a second segment and further comprising observing the barrel for a blood volume before and after a segment of the single directional actuation. 15. The method of claim 14,
Wherein the single directional actuation of the drive mechanism comprises a first moving segment and a second moving segment of the actuator. 18. The method of claim 17,
Further comprising observing the barrel for a blood volume before and after the actuator enters the second moving segment. 18. The method of claim 17,
Wherein the syringe dispenses a predetermined base mass, of the second moving segment of the actuator. The method of claim 19,
Further comprising adjusting the drive mechanism to adjust a predetermined substrate mass. 15. The method of claim 14,
Further comprising maintaining a cannula operating the drive mechanism to move the plunger and barrel relative to each other in a first direction and then in a second direction without moving the cannula. Way. CLAIMS 1. A method of administering an infusion of a substrate to a patient comprising:
Positioning an infusion device adjacent a patient ' s tissue, the infusion device having a reservoir therein with a slidable plunger and a cannula extending from the barrel;
Advancing the cannula into a tissue location; And
Operating the lever with one hand so that the plunger first increases the volume of the reservoir and then the plunger decreases the volume of the reservoir to deliver the substrate to the patient. An apparatus for delivering an implant of a substrate into a tissue region comprising:
A reservoir configured to maintain the substrate;
A plunger coupled to the reservoir such that movement of the plunger changes the volume of the reservoir;
A cannula communicatively coupled to the reservoir at the distal end and configured to penetrate the tissue region; And
And an actuator mechanically coupled to the plunger,
Wherein the actuator is configured to move from a rest position to a delivery position, wherein the partial movement of the actuator from the rest position creates movement of the plunger in a first direction, Wherein the movement creates movement of the plunger in a second direction, the first direction being opposite to the second direction. A dispensing unit for use in a syringe having a barrel and a slidable plunger relative to the barrel for dispensing a substrate located therein,
A housing assembly configured to secure a barrel of the plunger such that a distal end of the barrel is adjacent a distal end of the housing assembly;
A driving mechanism coupled to the housing assembly and including a plunger fitting coupled with the plunger;
An actuator configured to move in a single direction stroke including a first stroke segment and a second stroke segment; And
And a gear drive assembly coupled between the plunger fitting and the actuator,
Wherein the gear drive assembly is configured to move the plunger fitting in a first direction relative to a distal end of the housing of the first stroke segment and then in a second direction of the second stroke segment opposite the first direction, The dispensing unit being configured to move in response to movement of the actuator. 26. The method of claim 25,
Wherein a portion of the gear drive assembly is detachable such that the plunger fitting moves forward in a single stroke of the actuator. 26. The method of claim 25,
Wherein the gear drive assembly includes at least one first gear structure configured to create movement of the plunger fitting in a backward direction and a second gear structure configured to create movement of the plunger fitting in the forward direction,
Wherein movement of the actuator in the first segment causes movement of the first gear structure and movement of the actuator in the second segment causes movement of the second gear structure in the first segment, Causing a movement. 28. The method of claim 27,
Wherein the drive gear assembly is separate from the first gear structure during movement of the actuator in a second segment. 28. The method of claim 27,
Wherein the first gear structure is releasably coupled to the actuator through a first axis such that movement of the actuator through the first segment to the second segment causes separation of the actuator and the first axis, . The syringe has a barrel and a slidable plunger relative to the barrel for dispensing a substrate disposed therein within the cannula for use in a syringe configured to permit one hand operation to deliver an infusion by a user , As a dispensing unit:
A housing having a drive mechanism associated therewith, the actuator including an actuator for moving the gear assembly to advance the plunger fitting; And
And at least a plurality of recesses having an outline shape on the housing,
The housing has a loading surface, a base surface, a lever-side, and a support-side,
The loading surface including a window that exposes a drive assembly that permits insertion of the syringe into the housing in alignment with a longitudinal axis of the housing such that a distal end of the barrel is adjacent a distal end of the housing, Extending beyond the distal end of the housing, the plunger of the syringe being engageable with the plunger fitting,
The base surface is configured to maintain the housing in a rest position when positioned on an outer surface and also allows the stability of the housing to be maintained when the syringe is coupled through the window,
The plurality of recesses including a base recess located on the base surface and a support recess extending from the base recess toward the distal end of the housing along the support side;
Wherein the support recess and base recess are positioned to allow respective seats of the thumb and dorsal web of the user's hand while the distal end of the index finger engages the actuator such that the index finger Of the distribution unit. 32. The method of claim 30,
Further comprising an indicator located in at least one of the plurality of recesses that allows identification of the recess. 32. The method of claim 31,
Wherein the indicator comprises a tactile or visual indicator. 32. The method of claim 30,
When the cannula is inserted into or removed from the patient, the support recess may have at least one directional-force surface substantially transverse to the longitudinal axis of the housing such that the user can apply a normal force to the directional-force surface A dispensing unit. 32. The method of claim 30,
Further comprising a lever recess extending along the lever-side from the base recess toward the distal end of the housing, the lever recess permitting seating of the forefinger on the actuator side of the housing. 35. The method of claim 34,
And an indicator positioned on said lever recess allowing said identification. 32. The method of claim 30,
The lever recess has at least one directional-force surface substantially transverse to the longitudinal axis of the housing, such that when the cannula is inserted into or removed from the patient, the user depresses or pulls the directional-force surface, . ≪ / RTI > 32. The method of claim 30,
Further comprising an index recess located on the actuator side of the housing and adjacent the distal end, the index recess permitting the seating of the distal end of the additional finger to further stabilize the housing during movement of the actuator. 37. The method of claim 37,
Further comprising an indicator positioned on said index recess allowing said identification. 32. The method of claim 30,
Further comprising a cover on the window of the loading surface, the cover being removably coupled to the housing. 32. The method of claim 30,
Further comprising an actuation surface coupled to the actuator. 41. The method of claim 40,
Further comprising an indicator located on the operating surface that allows identification thereof. 32. The method of claim 30,
Further comprising a gear drive assembly coupled between the plunger fitting and the actuator, wherein the gear drive assembly is movable in a first direction relative to a distal end surface of the housing and subsequently in a second direction opposite the first direction And move in response to movement of the actuator to create movement of the plunger fitting. 32. The method of claim 30,
Further comprising a plunger fitting and a gear drive assembly coupled to the plunger fitting and the actuator, wherein the plunger fitting and the plunger fitting are coupled to the plunger fitting and the actuator, And move in response to movement of the actuator to create movement of the fitting. 32. The method of claim 30,
Wherein the gear drive assembly moves the plunger fitting in the first direction and then in the second direction at a single stroke of the actuator. 32. The method of claim 30,
Wherein a portion of the gear drive assembly can be disengaged such that the plunger fitting moves in a second direction in a single stroke of the actuator. 32. The method of claim 30,
Wherein the gear drive assembly includes at least one first gear structure configured to generate movement of the plunger in a first direction and a second gear structure configured to generate movement of the plunger in a second direction,
Wherein movement of the actuator in the first segment causes movement of the first gear structure and movement of the actuator in the second segment causes movement of the second gear structure in the first segment, Causing a movement. 47. The method of claim 46,
Wherein the drive gear assembly is separate from the first gear structure during movement of the actuator in the second segment. 47. The method of claim 46,
Wherein the first gear structure comprises a rack and pinion assembly. 47. The method of claim 46,
And the second gear structure comprises a rack and pinion assembly. 47. The method of claim 46,
Wherein the first gear structure is releasably coupled to the actuator via a first axis such that movement of the actuator through the first segment to the second segment causes separation of the actuator and the first shaft, . 47. The method of claim 46,
Wherein the second gear structure is separate from the actuator until the actuator moves through the first segment. 47. The method of claim 46,
And the second gear structure is coupled to the actuator via a second axis. 32. The method of claim 30,
Wherein the actuator is coupled to a pivot shaft rotatable relative to the housing assembly, and wherein a portion of the shaft is coupled to the gear drive assembly. 54. The method of claim 53,
Wherein the pivot axis is located proximate the barrel. A method for injecting a substrate into a patient comprising:
Positioning the syringe adjacent a patient ' s tissue location, the syringe being secured to a housing having a drive mechanism including an actuator for moving a gear assembly to advance a plunger fitting coupled to the plunger of the syringe;
In order for the forefinger to move the actuator and perform the infusion, one end of the forefinger is coupled to the actuator to allow the syringe to advance to the patient, Holding the housing with one hand so that the thumb and dorsal web of the housing are respectively seated in the support recess and base recess,
Wherein the housing has a loading surface, a base surface, a lever-side, and a support-side, at least a plurality of recesses having an outline shape on the housing, the plurality of recesses having a base recess located on the base surface, And a support recess extending from the base recess toward the distal end of the housing along the support side.

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