JP2017518858A - Hand-held medical substance dispensing system, apparatus and method - Google Patents

Abstract

Various handheld medical dispensing structures and methods include the following: a handheld medical dispensing system includes a syringe having a plunger that is releasably attached to a syringe actuator, the device moving the plunger more than once. A housing having an actuator configured to allow a plurality of quantities of material to be dispensed from the syringe and adapted for one-hand administration of infusion. A method of ejecting fluid from a syringe is to hold a medical substance delivery system including the syringe, the syringe having a needle and configured to eject a predetermined amount of the substance from the syringe Securing the needle, penetrating the needle into one patient site and using the device to deliver a predetermined amount of substance, and penetrating the needle into another patient site and the device Using to deliver a predetermined amount of a substance. [Selection] Figure 11B

Description

  The present invention relates to a handheld medical substance dispensing system, apparatus and method.

[Related applications]
This application is a continuation-in-part of U.S. Patent Application No. 13 / 550,473, filed July 16, 2012, U.S. Patent Application No. 14 / 286,701, filed May 23, 2014. This is a continuation application of the issue. This application is also a continuation-in-part of U.S. Patent Application No. 13 / 550,473, filed July 16, 2012, U.S. Patent Application No. 14/286, filed May 23, 2014. This is a continuation of US patent application Ser. No. 14 / 481,708, filed Sep. 9, 2014, which is a continuation-in-part of 701. Each of the above applications is incorporated herein by reference in its entirety.

  In the field of cosmetic surgery, non-invasive procedures have gained more and more popularity over the past decade. The most common treatments include injecting liquid filler into facial lines and wrinkles to provide wrinkle reduction and smoothing, and the use of agents that numb the selective muscles of the face . Usually, skin fillers or numbing agents such as Botox® cosmetics (Onabotulinum toxin A) are used on a recurring outpatient basis. Such agents are usually available in sterile vials of the product in lyophilized form. The clinician reconstitutes the formulation according to a specific formulation of sterile saline (fluid) added to the product vial. Once mixed, the formulation is drawn into a syringe for delivery subcutaneously using a small diameter medical needle. The most common delivery method uses a 1 cc disposable syringe fitted with a disposable needle. Importantly, a small, reproducible distribution of fluid is delivered to facial muscles, such as frontal muscles, in multiple facial injections in the facial area that would benefit from the treatment.

  In addition, the use of a small syringe during injection into the face of a subject sitting in a chair is generally cumbersome for a health care provider, while trying to hold the syringe stably, while the rear end of the syringe assembly It is known to be subject to unstable operation of the syringe due to the need to push the plunger located at.

  Thus, a handheld that can deliver a more stable or desired amount of filler or fluid from a handheld dispenser or syringe in such applications to provide predictable and / or desired results. There remains a need to provide a dispenser or syringe.

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

  One variation of the device disclosed herein includes a dispensing unit for use with a syringe. For example, such a device can include a syringe having a barrel and a plunger slidable relative to the barrel to dispense a substance located within the barrel, wherein the medical dispensing system is a housing assembly. A housing assembly configured to secure the barrel of the plunger such that the distal end of the barrel is adjacent to the distal end of the housing assembly; a drive mechanism coupled to the housing assembly, wherein the drive mechanism is associated with the plunger. A drive mechanism comprising an engaging plunger fitting; an actuator; and a gear drive assembly coupled between the plunger fitting and the actuator, wherein the gear driving assembly moves in response to movement of the actuator and is coupled to the distal end of the housing. In the direction of 1, followed by the second direction opposite to the first direction Is configured to generate the movement of the plunger fitting comprises a gear drive assembly.

  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. Further, in certain variations, a portion of the gear drive assembly can be disengaged so that the plunger fitting moves in the second direction in a single stroke of the actuator.

  As noted herein, a dispensing unit disclosed herein includes at least a first gear structure configured to generate movement of a plunger fitting in a first direction; and A gear drive assembly comprising a second gear structure configured to generate movement of the plunger fitting in a second direction can be included; a single stroke of the actuator includes the first segment and the second The first gear structure is moved by the movement of the actuator in the first segment, and the second gear structure is moved by the movement of the actuator in the second segment. In a further variation, the gear drive assembly disengages the first gear structure during movement of the actuator in the second segment.

  As described herein, a variation of the dispensing unit can use one or more rack and pinion gear assemblies. However, any such mechanism can be used to achieve the same result.

  An example of a dispensing unit includes one or more first gear structures releasably connected to an actuator by a first shaft, thereby moving the actuator from the first segment to the second segment. Thus, the first shaft and the actuator are disconnected. In a further variation, the second gear structure can be detached from the actuator until the actuator moves through the first segment.

  In another variation, the dispensing unit is a syringe having a barrel and a plunger slidable relative to the barrel to dispense a substance located within the barrel; a housing assembly; A housing assembly configured to secure the barrel of the plunger such that the distal end of the barrel is adjacent to the distal end of the housing assembly; a drive mechanism coupled to the housing assembly, the plunger engaging the plunger A drive mechanism comprising a fitting; and an actuator; and a gear fitting assembly coupled to the plunger fitting and the actuator, wherein the gear drive assembly moves in response to movement of the actuator and in a first direction relative to the distal end of the housing Followed by a plunge in a second direction opposite to the first direction Is configured to generate the movement of the fitting may include a gear drive assembly.

  The present disclosure also includes a method of injecting a substance into a patient. In one example, the method is to position a syringe adjacent to a patient's tissue site, the syringe having a plunger coupled to the barrel and a cannula extending from the barrel; positioning the cannula; Advancing into the site; activating a drive mechanism coupled to the syringe, wherein the drive mechanism causes the plunger and barrel to be first relative to each other upon actuation of the actuator of the drive mechanism in a single direction. , Followed by actuating configured to move in a second direction opposite to the first direction.

  In another variation, the method is, for example, positioning the infusion device adjacent to the patient's tissue site, the infusion device having a reservoir having a plunger slidable therein and a cannula extending from the barrel. Advancing the cannula into the tissue site; actuating the lever with one hand, first increasing the volume of the reservoir relative to the plunger, and subsequently decreasing the volume of the reservoir relative to the plunger; A method of administering an infusion of a substance to a patient by delivering the substance into the patient can be included.

  Another variation of the device according to the invention comprises a device for administering an injection of a substance into a tissue region, the device being a reservoir configured to hold the substance; a plunger coupled to the reservoir, the plunger A plunger that allows the volume of the reservoir to change upon movement of the cannula; a cannula that is fluidly connected to the reservoir at the distal end and is configured to penetrate the tissue region; mechanical to the plunger Wherein the partial movement of the actuator from the rest position generates a movement of the plunger in a first direction, and is delivered to the delivery position. The continued movement of the actuator towards the position generates a movement of the plunger in the second direction, where the first direction is the second direction and The opposite, comprises an actuator.

  Any feature (s) of any embodiment or variant may be combined with any feature (s) of another embodiment or variant, whether preferred or not. For example, any of the embodiments or variations can have any one or combination of the following features: a syringe plunger, and moving the syringe plunger more than once in multiple amounts (or volumes) An actuator having an actuator for dispensing a substance; a fastener for fastening a syringe to the syringe actuator; a syringe having a needle; an actuator including a syringe plunger and a pusher for pushing the syringe plunger; a pusher and / or a plunger An actuator including a drive or drive assembly coupled to a syringe plunger pusher for driving; an actuator including a lever pivotally coupled to a syringe actuator for operating the drive or drive assembly; a barrel; and Adjacent to the distal end of the barrel and of the barrel A syringe having a lever having a distal end radially spaced from the distal end; a lever having a distal end, and a syringe having a barrel and a needle, the lever (e.g., throughout its entire stroke) and a needle Syringe in non-overlapping relationship; connected to a syringe actuator and having a contact portion in a predetermined position to limit the advancement of the lever to a predetermined (or desired or predetermined) amount (or volume) from the syringe A stop member for discharging the substance; having a contact portion connected to the syringe actuator and having an adjustable position, for providing a variable default stop for the advancement of the lever, for the substance discharged from the syringe; A stop member that can change a predetermined (or desired or predetermined) amount (or volume); the position of the travel limiting device is adjusted to adjust the travel of the lever Multiple and variable predetermined (or desired or predetermined) quantities (or volumes) of substance can be dispensed from the syringe; multiple predetermined (or desired or predetermined) An actuator configured to deliver an amount (or volume) of material from a syringe or to deliver a different predetermined (or desired or predetermined) amount (or volume) of material from a syringe; one hand of a user Syringe-actuated device fitted with a syringe, held in place and configured to be operated or used only by its hands; contains medicines used in the treatment of facial lines and / or wrinkles A syringe; a reusable syringe actuator; a syringe actuator having a plurality of syringe supports to which the syringe is attached or fixed; a syringe is attached or A syringe actuator having a surface that is fixed (eg, a curved surface); or an actuator to which the syringe is releasably attached.

  Furthermore, the dose or dose can be the amount of a substance.

  The present disclosure also includes a dispensing unit used with a syringe and configured to allow delivery of infusion by one-handed actuation by a user. For example, in such a system, the syringe can include a barrel and a plunger that is slidable relative to the barrel so as to dispense material located within the barrel through the cannula. The discharge unit is a housing to which a drive mechanism is coupled, and the drive mechanism includes an actuator that moves the gear assembly to advance the plunger fitting; the housing includes a loading surface, a base surface, a lever side, and Including the support side: the loading surface includes a window, the window exposes the drive assembly, and the syringe has a distal end of the barrel adjacent the distal end of the housing and a cannula extending beyond the distal end of the housing. Can be inserted into the housing in alignment with the longitudinal axis of the housing, and the plunger of the syringe is engageable with the plunger fitting; the base surface rests the housing when positioned on the outer surface Constructed to maintain the stability of the housing when connecting the syringe through the window At least a plurality of recesses having a contoured shape on the housing, wherein the base recesses are positioned on the base surface and along the support side from the base recesses toward the distal end of the housing The support recess and the base recess may include at least a plurality of recesses, including an extended support recess, while the index finger end engages the actuator and is oriented toward the distal end when the index finger moves the actuator. Are positioned to allow nesting of the thumb and dorsal web of the user's hand respectively.

  The dispensing unit may further include at least one distal recess positioned on the lever surface and adjacent to the loading surface, the distal recess being in the housing on the opposite side of the support housing by application of the middle finger of the user's hand. Allows you to apply power.

  In another variation, the dispensing housing can include one or more indicators positioned in at least one of the plurality of recesses to allow identification of the recesses. Such indicators can include tactile or visual indicators.

  Further variations of the housing can include at least one directional force surface substantially transverse to the longitudinal axis of the housing so that the user can insert or remove the cannula from the patient. In addition, a force perpendicular to the directional force surface can be applied. Alternatively or in combination, the housing of the dispensing unit can include a lever recess having at least one directional force surface substantially transverse to the longitudinal axis of the housing, whereby the user can connect the cannula to the patient Can be pushed or pulled against the directional force surface when inserted into or removed from the patient.

  In another variation, the housing can further include a lever recess that extends from the base recess along the lever side toward the distal end of the housing, the lever recess allowing the index finger to be nested on the actuator side of the housing. To do.

  Further, the housing body variant may include an index recess positioned on the actuator side of the housing and adjacent to the distal end, the index recess allowing further finger end nesting during actuator movement. To further stabilize the housing.

  Variations of the device can include an actuation surface coupled to the actuator, and such actuation surface can include an indicator for its identification.

  The housing described herein can be coupled to any drive assembly similar to the drive assembly described herein or described herein.

  In another variation, the present disclosure includes a method of injecting a substance into a patient, the method comprising: positioning a syringe adjacent to a patient's tissue site, the syringe moving a gear assembly to move the syringe Fixed in a housing having a drive mechanism with an actuator for advancing a plunger fitting coupled to the plunger of the housing; wherein the housing is on the loading surface, base surface, lever side and support side, and on the housing At least a plurality of recesses having a contoured shape, the plurality of recesses including a base recess positioned on the base surface, a support recess extending from the base recess toward the distal end of the housing along the support side; Gripping the housing with one hand so that the thumb of the hand and the crotch of the dorsal finger Each is nested within the base recess to allow advancement of one hand of the syringe into the patient and the end of the index finger engages the actuator and the index finger moves the actuator to perform the injection Including gripping, allowing it to remain oriented toward the distal end.

  The above is a brief description of some deficiencies in the prior art and the advantages of the present invention. Other features, advantages, and embodiments of the invention will be apparent to those skilled in the art from the following description and accompanying drawings, and specific forms of the invention are set forth in detail for purposes of explanation only. Variations of the access devices and procedures described herein include, where possible, combinations of features of the various embodiments or combinations of the embodiments themselves.

1 is an exploded view of a handheld dispensing system (or apparatus) according to one embodiment of the present invention. FIG. FIG. 2 schematically shows a side view of the embodiment of FIG. 1 with the syringe attached to the syringe actuator of the system of FIG. 1 and the actuator pusher member spaced from the syringe plunger assembled; The illustrated lever arm is partially depressed to engage the pusher member with the thumb portion of the syringe plunger and advance the syringe plunger to push a small amount of fluid out of the syringe needle to prepare the device for use. FIG. 3 schematically shows the system of FIG. From the opposite side, after the lever arm is released and allowed to return to its starting or resting position as shown in FIG. 2, it is advanced towards the target site on the patient's skin FIG. 4 is a diagram schematically showing the system of FIG. 3. After the operator or physician has inserted the needle into the patient's skin, fully depressed the lever arm to engage the lever stop, and dispense a desired amount or a predetermined and / or predetermined volume of material from the syringe FIG. 5 schematically shows the system of FIG. 4. 5 schematically shows the system of FIG. 5 after the system needle has been removed from the patient and the lever arm has been released allowing it to return to its starting or resting position as shown in FIG. It is. FIG. 3 is a schematic partial cross-section generally along line 7A-7A in FIG. FIG. 7B is a top view of the housing shown in FIG. 7A, showing the edge of the side wall of the housing secured to the frame or base of the syringe actuator. FIG. 2 is a top view of the lever arm stop device or assembly shown in FIG. 1, for example. FIG. 7B is a schematic enlarged partial cross-sectional view of the release mechanism shown schematically in FIG. 7A. FIG. 7D schematically shows the push button and the lever arm of FIG. 7D rotated 180 degrees. FIG. 7D schematically shows a cross-sectional view generally along line 7F-7F of FIG. 7D. FIG. 7B schematically illustrates the ratchet mechanism generally shown in FIG. 7A for advancing the pusher member. FIG. 8B schematically shows the mechanism of FIG. 8A with the ratchet gear of FIG. 8A rotating and the pusher member advanced. FIG. 8B schematically shows the mechanism of FIG. 8B with the ratchet gear of FIG. 8A further rotating and the pusher member further advanced. FIG. 8D schematically shows the mechanism of FIG. 8C with the pawl moving inward and the pusher member reset or retracted. FIG. 3 schematically illustrates one method of holding the system of FIG. 2 with one hand. FIG. 5 is an isometric view of a variation of a dispensing unit configured to create a negative pressure in a barrel or reservoir before delivering the contents of the substance into the reservoir. FIG. 11 is a front view of the device 100 of FIG. 10. FIG. 11 is a rear view of the device 100 of FIG. 10. FIG. 5 shows an example of a gear drive assembly during movement of an actuator through a first stroke segment. FIG. 5 shows an example of a gear drive assembly during movement of an actuator through a first stroke segment. FIG. 5 shows an example of a gear drive assembly during movement of an actuator through a first stroke segment. FIG. 5 shows an example of a gear drive assembly during movement of an actuator through a first stroke segment. FIG. 5 shows an example of a gear drive assembly during movement of an actuator through a first stroke segment. It is a figure which shows detachment | leave of a back drive gear mechanism. FIG. 11 is a bottom view of the variation shown in FIG. 10. It is a figure which shows the movement of the actuator for making a plunger fitting advance. It is a figure which shows the movement of the actuator for making a plunger fitting advance. It is a figure which shows the movement of the actuator for making a plunger fitting advance. FIG. 6 shows another variation of the device in which the barrel moves relative to the plunger to generate negative pressure. FIG. 6 is a diagram showing another variation of the device in which the barrel moves relative to the plunger to generate negative pressure. FIG. 6 shows another variation of a component used with an infusion system including a housing and a circuit portion. FIG. 6 shows another variation of the dispensing unit with a modified housing that improves the ability of the user to administer one-hand positioning and actuation of the unit. FIG. 6 shows another variation of the dispensing unit with a modified housing that improves the ability of the user to administer one-hand positioning and actuation of the unit. FIG. 6 shows another variation of the dispensing unit with a modified housing that improves the ability of the user to administer one-hand positioning and actuation of the unit. FIG. 6 shows another variation of the dispensing unit with a modified housing that improves the ability of the user to administer one-hand positioning and actuation of the unit. FIG. 6 shows another variation of the dispensing unit with a modified housing that improves the ability of the user to administer one-hand positioning and actuation of the unit. 17A-17E illustrate an example of how the housing of FIG. 17E facilitates one-handed operation of the injection unit. 17A-17E illustrate an example of how the housing of FIG. 17E facilitates one-handed operation of the injection unit. FIG. 6 shows another variation of the housing that is intended to engage a user's hand or finger to various marked portions of the housing. FIG. 6 shows another variation of the housing that is intended to engage a user's hand or finger to various marked portions of the housing. FIG. 6 shows another variation of the housing that is intended to engage a user's hand or finger to various marked portions of the housing. FIG. 6 illustrates another related concept including a sensing unit used with a conventional syringe and / or an infusion system of the present disclosure. FIG. 6 shows another related concept including a conventional syringe and / or a retention unit used with the infusion system of the present disclosure.

  Before describing the present invention, it is to be understood that the present invention is not intended to be limited to the particular embodiments or examples described, and can, of course, vary. Furthermore, like reference numerals refer to like elements when referring to the drawings.

  According to one embodiment of the present invention, the handheld pharmaceutical or medical substance delivery system (or device) is an actuating device that can be a mechanical actuating device, and a medical or medical dispenser (eg, a syringe). And the dispenser is attached or coupled to the actuator, thereby manually manipulating the actuator while holding the substance delivery system to remove substances (e.g., paralytic drugs, facial lines and wrinkles). Any suitable medicinal product or agent used in the treatment of a) is delivered from a dispenser to a patient site or target site (eg, a muscle layer directly under the skin) or to each of a plurality of patient sites or target sites can do. The actuating device may be configured to provide the operator flexibility in the amount of substance delivered, for example, by allowing the operator to determine the degree to which the actuating device is actuated. it can. For example, a lesser amount or volume of material is dispensed because the operator does not need to fully activate the actuator. The actuator can also be configured to allow the operator to deliver a desired, predetermined or predetermined amount or volume of material. It can also be configured to facilitate repeatable delivery of the same desired, predetermined or predetermined amount or volume of material, which can deliver a reproducible accurate amount or volume of material from the dispenser. Can be easily. The exact amount can correspond, for example, to a liquid droplet, and the size of the droplet can vary depending on values such as liquid density and ambient pressure, or 0.1 cc material. In contrast, delivery of an accurate and reproducible amount or volume of material is possible with the conventional method of holding the syringe in one hand and pressing the plunger with the thumb of the other hand or the same hand. Can also be difficult.

  In addition, the actuator described in the preceding paragraph may be provided with an optional adjustment mechanism to facilitate delivery of various desired, predetermined or predetermined amounts (or volumes) of substances or various doses or doses. can do.

  The substance delivery system can also be configured to be used with one hand (eg, in a manner similar to holding a pen), which increases the controllability and stability of the system in use. be able to. In addition, one-handed operation of the system allows the user (eg, operator or doctor) to do something else using their free hands. For example, when treating wrinkles using the system, one-handed operation allows the user's free hand to hold the patient's skin and stretch the skin in the wrinkled area, which is delivered Facilitates proper placement of the active substance with one hand. Thus, with this construction, one hand is used (ie, only one hand is required) to hold the agent or substance delivery system, manipulate to the desired site, and allow the syringe needle to penetrate at the desired site. Directing and manipulating the syringe actuator can inject a desired amount of agent or substance into the patient. In one embodiment in accordance with the present invention that facilitates such use, the actuator is one end adjacent or radially spaced from the distal portion or distal end of the syringe barrel and the other end to the actuator. Includes a lever actuator to be coupled. This can increase the control of one hand of the device. For example, the bottom of the delivery system can be held between the index finger, thumb, and the user's index finger used to depress the lever actuator in the crotch space of the finger of the hand. The end of the lever actuator adjacent the distal portion or end of the syringe barrel can be in a non-overlapping relationship with the exposed portion of the needle so as not to interfere with insertion of the needle into the patient. In addition, the lever can be pivotally attached to the device, so that the user can hold the system with one hand while holding the system with that hand and dispense the substance from the dispenser. With this lever structure, the user may be able to sense back pressure and control the delivery rate of the dispensed substance. The lever configuration can enhance the ability to use the device with one hand, thus improving its ease of use. Furthermore, the one-handed aspect can increase the stability of the system in use.

  The syringe actuator can also be configured to be reusable. For example, a dispenser or syringe is releasably or removably attached or coupled to a syringe actuator so that, for example, a used dispenser or syringe can be replaced with a new dispenser or syringe. be able to. Further, the actuator can be configured to be coupled to an in-stock medical dispenser or syringe.

  According to one embodiment of the present invention, a handheld pharmaceutical or medical substance dispensing system includes a barrel containing a pharmaceutical or medical substance that is releasably or removably attached to or coupled to an actuator base or frame. Provided with a syringe (or dispenser) that can have. The actuator includes a pusher (or slide) slidably attached to the base or frame of the actuator and a lever that can be displaced to actuate or move the pusher. The lever can be positioned with one end positioned adjacent the distal end or end of the syringe barrel to which the needle can be attached. The system can include a mechanism (eg, a stop positioned at a predetermined position to limit the maximum displacement from the start position of the lever) so that the lever is sufficiently displaced from the start position. When this is done, the pusher (or slide) is actuated and the syringe plunger is moved a certain reproducible distance within the syringe barrel (eg when the lever is fully displaced again from its starting position). In one variation, the specific distance traveled by the syringe plunger, which may be the same as the distance traveled by the pusher, can be adjusted, for example, the adjusted distance predetermines the maximum lever displacement to be adjusted. As such, it is reproducible using an adjustable mechanism. For example, the distance traveled by the pusher and syringe plunger can be defined using an adjustable stop that provides an adjustable limit for maximum displacement of the lever from its starting position, so The plunger distance and the substance to be dispensed can be changed.

  The distance traveled by this particular syringe plunger, which can be predetermined based on, for example, the position of the stop of the lever, translates into a known, similarly reproducible volume of the substance or material ejected from the syringe as described above. This allows the user to repeatedly deliver a desired, predetermined or predetermined amount of substance (eg fluid or paralytic) to the patient's face, for example, to treat facial lines or wrinkles Can be. The system may also be used to treat facial lines or wrinkles by repeatedly delivering doses of the aforementioned substances. The dosage can also be varied. Generally, the amount (s) or distance (s), travel (s), or displacement (s) that the lever, pusher, and plunger travel may be, for example, desired Discharging, delivering a predetermined or predetermined amount (s), volume (s), dose (s) or dose (s) of a substance; A stop of the lever can be established to extrude or inject. For example, the maximum lever displacement is predetermined so that the pusher and / or plunger moves a desired, predetermined or predetermined distance to dispense a desired, predetermined or predetermined amount of material from the syringe. be able to.

  In addition, the system can be configured to be supported with one hand, which can increase its stability during use, and the lever configuration allows the device to be used with one hand. The ability to improve ease of use can be enhanced.

  Referring to FIGS. 1 and 2, an illustrative example of one embodiment of the present invention is shown. FIG. 1 is an exploded view of a handheld medical substance dispensing, delivery, push-out or infusion system 100 that includes a syringe 200 and a syringe actuation and / or metering device or device 300. FIG. 2 shows a syringe 200 releasably or removably coupled to or attached to a syringe actuator 300.

  The syringe 200, which can be any standard hypodermic syringe, includes a hypodermic needle 202 that injects fluid (eg, liquid or gas) into body tissue, a barrel or tube 204 to which the needle is connected, and a barrel. A plunger 208 is slidably movable within 204.

  Returning to FIG. 1, the barrel or tube 204 has a distal end 204 a and a proximal end 204 b, and any known suitable numbing agent or skin for treating facial lines or wrinkles, for example. And has an orifice for fluid discharged from one end to the needle 202 at one end. Plunger 208 has a piston head 210 that fits snugly within barrel 204 and a thumb actuator or handle 212 that can be pushed to expel fluid from the barrel and needle. The barrel can be provided with a distal tapered tip 206 to which the needle is attached or attached and is transparent so that the amount of fluid or substance inside can be monitored. can do. The syringe barrel 204 has graduated marks or indicia 214a, b, c, d, e, f,. . . n can be present. In the illustrative example, the volume between any two of these lines (eg 214d and 214e) corresponds to 0.1 cc. The mark between these lines further indicates an amount of 0.05 cc. Any suitable material such as plastic or glass can be used to make the barrel.

  Although one syringe structure is shown, any suitable syringe structure as would be apparent to one skilled in the art can be used. For example, a syringe can be used that does not have a needle but can be fitted with a needle, for example a disposable needle.

  Prior to attaching the syringe to the base, the operator or physician performs an air venting procedure as is known in the art and taps the syringe while holding the syringe with the needle pointing up and then the syringe plunger. Some liquid can be discharged by pressing. Alternatively, the operator or physician can evacuate air from the syringe using the syringe actuator 300, as described in more detail below.

  The syringe 200 is releasably or removably connected to or attached to a syringe actuation or metering device or device 300. In the illustrative example, the syringe actuator 300 includes a base or frame 302 to which a syringe support 304 is attached. Alternatively, the frame and support, which can be any suitable material such as plastic, can be integrally formed as a single piece configuration. As shown in FIG. 7A, the support 304b has a curved surface that can receive the syringe barrel 204 (eg, can be a concave or U-shaped surface). The support 304a, which is hidden from the view of FIG. 7A, has the same structure. Although one curved surface is shown formed on the support 304b, any other suitable surface that supports the syringe can be used.

  The syringe 200 can be secured to the base 302 of the syringe actuator using any suitable means. In the illustrative example, straps 306a, b secure syringe barrel 204 to support 304a, b (see, eg, FIGS. 2 and 7A). Since each strap is fixed to the respective support in the same way, only the fixing of the strap 306b is described for simplicity. The strap 306b has a first end 306b1 that is firmly fixed to the support 304b (eg, along the support side) and a second that is removably fixed to the support 304b (eg, the other side of the support). Because of this end 306b2, the strap extends across the syringe barrel and eliminates or minimizes relative axial movement between them by holding the syringe barrel snugly against the support. Any suitable removable fixation mechanism can be used to removably fix the second end 306b2 to the support. For example, hook-and-loop fasteners that can be Velcro® brand hook-and-loop fasteners can be used. A hook fastener band may be provided along one side of the strap and engaged with a loop band provided along a portion of the support. Alternatively, a loop fastener band may be provided along one side of the strap and engaged with a hook band provided along a portion of the support. In one variation, both strap ends can be removably secured to their respective supports. It should also be understood that although two supports are shown, one support, two supports, three or more supports can be used, or no support can be used. For example, a curved surface can be formed in the base 302, or no curved surface is provided, in which case a securing mechanism is still used to secure the syringe 200 to the syringe actuator 300.

  The syringe actuator 300 also includes an actuator that can move the syringe plunger 208 toward the syringe needle 202 to dispense or inject a plurality of desired or predetermined volumes of material. In the illustrative example, one such actuator is shown and includes a pusher or pusher member 308, a lever or lever arm 320, and a drive or drive assembly that couples the pusher member 308 and lever arm 320. A mechanism for changing the desired volume or predetermined volume of material to be dispensed can also be included as described below with reference to the exemplary embodiment shown in FIG. However, although one actuator configuration is described, the syringe plunger 208 can be moved within the syringe barrel 204 toward the syringe needle 202 to dispense or push out a plurality of desired or predetermined volumes of material. It should be understood that other actuator configurations and other mechanisms that alter the desired or predetermined volume of material to be dispensed or injected into the patient can be used.

  Referring to FIGS. 1 and 7A, the base 302 has a longitudinal channel or slot 302a formed therein, and a pusher 308 is slidably mounted in the longitudinal channel or slot 302a so that the pusher 308 is When the syringe is attached to the base 302 as shown in the drawing, it can move generally parallel to the plunger 208 of the syringe 200. The slot 302a can extend the entire length of the base 302 and can have a structure that cooperates with the structure of the pusher 308, for example, as shown in FIG. 7A, so that the pusher 308 can be connected to, for example, FIG. When in the orientation as shown, it remains in the slot and does not fall off the base 302. In the illustrative example, slot 302a has a first width 302a1 adjacent to the opening having a first width, and a first width having a second width wider than the first width. And has a second portion 302a2 positioned towards it. The pusher 308, as shown in FIG. 7A, has a corresponding first width adjacent to its teeth 310 and a second extension that fits into a wider portion of the slot 302a. Have a width. Although one slot-pusher structure is shown, it should be understood that other structures or mechanisms may be used to maintain the pusher 308 in a slot formed in the base 302. For example, as described below, when the ratchet gear housing 314 is secured to the base 302 and engages and locks the ratchet gear 316 to the pusher teeth 310, the ratchet gear 316 is formed with the pusher 308 on the base 302. The pusher can have a single width. However, the slot structure as described above is useful in assembling the device and avoids the need for a ratchet gear holding the pusher. The housing 314 may also include separate components that are assembled around a mechanism that is mounted therein, as will be apparent to those skilled in the art. It should also be understood that the housing 314 can have other forms than the circular form shown. For example, the housing 314 can be square or rectangular with one side open so that it can be attached to the base 302.

  Pusher tooth 310 extends along its length from the bottom of pusher 308 and cooperates with drive gear tooth 318 of ratchet gear 316 so that ratchet gear 316 has pusher 308 and plunger portion 212 shown in FIG. When engaged, the pusher 308 can be moved or driven toward the plunger handle or plunger thumb actuator portion 212 of the syringe plunger 208, or the pusher 308 and plunger portion 212 can be moved therewith. The pusher 308 includes a portion or extension 309 that extends in a direction opposite to the pusher teeth 310 and is arranged or aligned to be engaged and pressed against the plunger handle or plunger thumb portion 212 of the syringe plunger 208. The Thus, pusher portion 309 advances the plunger within syringe barrel 204 as pusher 308 moves toward the distal or needle end of syringe 200. For example, in FIG. 4, as system 100 moves toward the patient's treatment site as indicated by directional arrow 102a, device 300 is in a state where pusher 308 does not advance plunger 208. Next, the needle 202 penetrates the patient's skin “S” at the treatment site, as shown in FIG. 5, after which the lever 320 is fully depressed in the direction of arrow 322 to cause the ratchet gear 316 to move to the arrow 324. And push the pusher 308 and plunger 208 with it in the direction of 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 indicated by the directional arrow 102b (FIG. 6) without moving the ratchet gear or plunger. This can be repeated at one or more different sites to deliver a desired or predetermined amount of substance to the patient at each site.

  Any suitable known ratchet assembly, such as a ratchet assembly having a ratchet gear with inner ratchet teeth and outer gear teeth combined with a spring-loaded pawl, can be used as part of the drive to drive the drive in one direction. Can be rotated.

  Referring to FIGS. 7A and 8A-8B, one drive or drive assembly that uses a ratchet mechanism is shown in an exemplary embodiment for illustrative purposes. In this example, lever arm 320 is coupled to pusher 308 through a drive or drive assembly. The illustrated drive or drive assembly includes a ratchet mechanism 312 (eg, see FIG. 8A) that generally includes a ratchet gear 316, which, as described in more detail below, includes a drive gear wheel and pawl 342a, Also works as b. Briefly, the lever 320 turns or operates the ratchet gear 316 to drive the pusher 308 toward the distal end of the syringe 200.

  The ratchet mechanism 312 housed in the ratchet housing 314 (see, eg, FIG. 8A) with the shaft or pin 336 extending to the lever arm 320 (FIG. 7A) has an inner ratchet tooth 317 on its inner annular surface. A ratchet gear 316 extending therethrough is included. The ratchet gear 316 also has outer gear teeth 318 that cooperate with the pusher teeth 310 to drive the pusher 308 in the direction indicated by arrow 326 as shown in FIG. Form a gear. The inner ratchet teeth 317 are pivotally connected to or on the nail support 340 fixedly secured to a pin or shaft 336 extending through a central hole formed in the nail support 340. Cooperates with supported ratchet pawls 342a, b. The ratchet pawls 342a, b are pivotally attached to the pawl support or gear 340 on pins 344a, b fixed to the pawl support 304 (see, eg, FIG. 8A) and spring biased by a spring. , Thereby being biased or pushed toward the inner teeth 317, allowing the ratchet gear 316 to rotate only in one direction (see, eg, arrow 324 in FIG. 8B). In the exemplary embodiment, coil springs 346a, b are placed in the recesses of the support 340 and are arranged to urge or push the pawls toward the inner teeth 317. However, it should be understood that other spring configurations or structures can be used, including those that do not have a recess or that use other types of springs as would be apparent to one skilled in the art. Further, the pawls 342a, b are made to include beveled or wedge portions 343a, b to help release the pawls from the ratchet gear, as described in more detail below. In operation, when a lever 320 that is firmly secured to a pin or shaft 336 is depressed, the lever 320 moves in the direction indicated by reference numeral 322 in FIG. 5 to activate the drive assembly. That is, the lever 320 is firmly fixed to the claw support 340 and rotates the pin or shaft 336 that rotates the claw support 340, thereby rotating the claws 342a, b together. When the pawls 342a, b move with the rotating pawl support 340, they push the ratchet teeth 317 that are engaged and biased, and the ratchet gear 316 is indicated by an arrow 324 as shown in FIG. 8B. Rotate in the direction. The ratchet gear 316 rotates or pushes in this direction with its teeth 318 engaged with the pusher teeth 310, thereby driving or moving the pusher 308 in the direction of arrow 326, thereby pushing the extension or arm 309 of the pusher. Can engage and advance syringe plunger 208 to eject fluid. A lever arm spring, which can be a coil spring, when the lever 320 is allowed to return (for example, by releasing the lever arm 320) to its starting or resting position, for example as shown in FIG. 334 moves toward its rest position and lifts or moves lever arm 320 to its start or rest position in the direction indicated by arrow 327 (FIG. 6). In the example shown in FIGS. 1-7A, a spring 334 that pushes the lever 320 toward its starting or resting position is secured to one end 334 a that is secured to a post 335 extending from the base 302 and to the lever arm 320. The other end 334b. In this way, the spring 335 can maintain the lever arm in its starting or resting position when the lever arm is not depressed. As will be apparent to those skilled in the art, other mechanisms may be used to push lever arm 320 toward its starting or resting position.

  As the lever arm 320 returns to its starting or resting position, it rotates the pawl support 340 in the opposite direction through a pin or shaft 336. As the pawl support 340 rotates in the opposite direction, the pawls 342a, b slide over the teeth 317 of a continuous ratchet gear, shown in the illustrative example as an asymmetric structure, with each tooth on the other In comparison, it has a steeper slope on one side. However, it should be understood that other ratchet tooth configurations may be used. The lever arm 320 can be actuated again to further advance the ratchet gear 316 and pusher 308, which is repeated as desired as schematically shown in FIG. 8C.

  Although one drive or drive assembly is shown, many other drives or drive assemblies can be used as will be apparent to those skilled in the art, and illustrative examples are within the scope of the present invention. It should be understood that there is no intent to limit.

  Referring to FIG. 8D, the release of the pawls 342a, b to reset the pusher 308 is shown. When the pawl is moved radially inward as shown and as described in detail below, the user can push back pusher 308 as generally indicated by arrow 360 and the released ratchet gear Is rotated in the direction indicated by arrow 362. In this way, the user can reset the pusher 308 to a desired position (eg, after the syringe 200 has been removed, the device 300 for another syringe loaded with the desired agent or substance). Return to that position shown in FIG. 2 to be ready).

  With respect to the coupling of the lever arm 320 to the ratchet gear 316, the lever arm end 320b is secured to the shaft 336 or recess formed in the shaft 336 using any suitable means, and the pin or shaft 336 is optional Are secured to the pawl support or gear 340 (see, eg, FIGS. 7A and 7E). For example, glue arm, adhesive or welding can be used to secure the lever arm 320 to the pin or shaft 336 and a spindle connection can be provided between the pin or shaft 336 and the pawl support or gear 340. . Alternatively, all these connections can be made, for example, by glue, adhesive or welding. Thus, the lever arm 320 biased toward its rest or starting position (see, eg, FIG. 4) is depressed to move in the direction of arrow 322 (FIG. 5), pin 336 and pawl support Since gear 340 can be rotated and then released, lever arm 320 moves as indicated by arrow 327 (FIG. 6) and returns to its starting or resting position as shown (eg, FIG. 4 and FIG. 6).

  Referring to FIG. 7A, the pin or shaft 336 extends through the openings in the side walls 314a, b of the ratchet housing 314. A bearing or bushing 338 may be provided on the side wall 314a to facilitate or enhance rotation of the pin or shaft 336 therein. Alternatively, the materials used to make the shaft and housing sidewalls can be selected to facilitate the desired rotation of the shaft 336 in the sidewall 314a without the use of bearings or bushings. A push button 354, described in more detail below, extends through the sidewall 314b and provides a support on which the pin or shaft 336 can rotate. Again, as will be apparent to those skilled in the art, the material can be selected to facilitate the desired rotation.

  Referring to FIG. 7B, the ratchet housing 314 has a notch that exposes the side wall edges 315a, b, so that the side wall edges 315a, b are secured to the base 302 as shown in FIG. 7A. Can be done.

  The ratchet gear 316 is supported by pawls 342 a, b attached to pawl supports 340 attached to pins 336 attached in a housing 314 fixed to the base 302, so that the ratchet gear 316 is engaged with the pusher teeth 310. Together, they are supported in the housing 314. Alternatively, a ratchet gear retention mechanism can be used to maintain the ratchet gear in the desired position as shown in FIG. 7A. In this configuration, the ratchet gear holding mechanism 319 is an outer portion 319 a 1 and an inner portion 319 a 2 that are firmly fixed to the ratchet gear 316, and is aligned with the claw gear 340 and is moved relative to the claw gear 340. An inner portion 319a2 that is not fixed to the pawl gear 340 and a disc 319a that is rotatably attached to the shaft 336 and has a cylindrical hub 319b from which the inner portion 319a2 of the disc extends. Inner portion 319a2 is also rotatably attached to a shaft 336 extending through the central opening of inner portion 319a2. The inner portion 319a2 may be concave so as to be spaced from the claw gear 340. Further, the retention mechanism 319 can be formed as a single integral element and can include any suitable material, such as plastic.

  As described above, the lever arm 320 can be configured and / or arranged to facilitate use of one hand of the system. In the exemplary embodiment, lever arm 320 includes distal or free end 320a (FIGS. 1-6), proximal end 320b (FIG. 7E), and lever arm 320 in the direction of arrow 322 (eg, FIG. 5). ) (See FIG. 1-6) which can be used to push, actuate or use to push. Portion 321 can be angled to extend generally parallel to the longitudinal axis of syringe barrel 204 or syringe needle 202 when the syringe is attached to syringe actuator 300. The location of the portion 321 adjacent the distal end of the syringe barrel 204, and the structure shown, can increase the ease with which a finger can depress the lever 320. However, other structures can be used. The lever arm distal end or free end 320 a is arranged to move along the barrel 204. The lever arm distal end or free end 320a is also adjacent to the distal end of the syringe barrel 204, such as shown in FIGS. 4 and 5, so as not to interfere with the placement of the needle on the patient. The lever arm is shown in a non-overlapping relationship with the needle 202 over the entire stroke. The free end 320a of the lever or the distal free end of the lever 320 can also be radially spaced 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, predetermined or predetermined amount or volume of material. In one embodiment, a mechanism that limits the movement or advancement of the lever arm 320 in the direction of the arrow 322 (see, eg, FIG. 5) (or limits the maximum arc or arc length that can be advanced). Provided. As such, the limiting mechanism also limits the corresponding rotation of the ratchet gear 316 and the translational movement of the pusher 308. This limiting mechanism may cause the travel distance or displacement of the lever arm 320, ratchet gear 316 and / or pusher 308 to vary a plurality of desired, predetermined or predetermined when the lever arm 320 is fully depressed or activated from its starting position. Arranged so that a volume of material can be dispensed or pushed out of the syringe 200. Maximum movement of the lever arm 320 can be predetermined to drive the ratchet gear 316 and / or pusher a predetermined distance. In the illustrated embodiment, a lever stop or lever travel limit device (eg, a stop or limit device 328) is provided. The stop 328 has an arm 330 that extends from the ratchet housing 314 and rotates 90 degrees or any suitable amount to extend into the path of the lever arm 320. The arm 330 has a first portion 330a that extends from the housing 314 and a second portion 330b that extends in the path of the lever arm 320 (see, eg, FIG. 7C). The stop sets or defines a fully advanced position of the lever 320 because the lever 320 cannot travel beyond the stop. In another embodiment, the stop can be formed using a member that extends from the base 302 below the lever 320. If the stop does not have an adjustable stop member, the syringe actuator 300 is calibrated and extruded with the syringe 200 or any syringe or dispenser used with the syringe actuator 300 using known techniques. The location where the stop is positioned or defined to provide a desired, predetermined or predetermined amount or volume of material can be identified.

  Referring to FIGS. 1-6, the stop arm 330 of the stop 328 may change the maximum displacement of the lever arm 320, or the maximum stroke or maximum distance or arc traveled by the lever arm 320. Optional mechanisms or members can be included to vary the desired, predetermined or predetermined amount or volume to be dispensed. In the exemplary embodiment, the stop arm 330 can be provided with an optional stop member or optional screw bore in which the set screw 332 is rotatably positioned so that the set screw 332 can be raised and lowered, The range of movement that the lever arm 320 can travel can be changed or adjusted. The set screw 332 has a contact surface or portion 332a that the lever arm 320 contacts during its full advancement, and the position of the contact portion is adjustable because the set screw 332 can be raised and lowered, thereby allowing the syringe to move. The desired, predetermined or predetermined amount of material dispensed from can be varied. The set screw 332 is any suitable means that assists in rotating the set screw 332 up and down, such as a slot at its lower end, or any other suitable as will be apparent to those skilled in the art. Various mechanisms can be included.

  The set screw 332 can include indicia indicating the desired, predetermined or predetermined dispensing, pushing or injecting amount or volume, thus providing the desired, predetermined or predetermined amount or volume of material to be dispensed. It can be positioned or predetermined as desired. For example, the indicia may allow a user (e.g., operator or physician) to adjust the set screw 332 (stop member) (e.g., 0.1 cc, 0.2 cc or 0.3 cc from a syringe). The amount or volume of material dispensed can be varied. These volumes can correspond to, for example, a desired, predetermined or predetermined amount or volume of material to be dispensed. Syringe actuator 300 can be calibrated using known techniques with syringe 200 or any syringe or dispenser used with syringe actuator 300 to create and provide this result. For example, marker lines “1”, “2”, and “3” indicate that 0.1 cc, 0.2 cc, or 0.3 cc is removed from the syringe when lever arm 320 is fully displaced when set screw 332 is at a particular level. It can be created by calibrating the actuator 300 with the syringe 200 to be pushed out and providing a marker line on the set screw based on the result.

  Thus, for example with reference to FIGS. 2, 4 and 5, the system 100 calibrates so that the position of the stop member or set screw 332 can be predetermined, for example as shown in FIG. 2 or FIG. So that when the lever 320 is depressed from its starting position, for example as shown in FIG. 4, to the fully depressed position as shown in FIG. Move by a predetermined or predetermined distance (the pusher can move the same distance to provide this result) and a syringe with the desired, predetermined or predetermined push or 0.1 cc of substance (eg fluid) 200, where the lever arm contacts the set screw 332; When the set screw 332 is in this position, the bottom of the marker line “1” is aligned or flush with the top surface of the stop arm 300 (see, eg, FIG. 4). Referring to FIG. 2, the marker line “2” is created based on calibration to provide 0.2 cc of material (eg, fluid) and the stop member or set screw 332 is adjusted or lowered so that the marker If the bottom of line “2” is aligned or flush with the top surface of stop arm 330 and lever arm 320 is pushed from its starting position to where it touches stop member or set screw 332, 0. 2 cc of material (eg, fluid) is discharged from the syringe 200. Another marker line, eg marker line “3” (see eg FIG. 2), can be provided on the marker line 2 so that its bottom is aligned with the top surface of the stop arm 330. Alternatively, when the lever arm 320 is pushed down from its starting position to a position where it comes into contact with the stop member or the set screw 332 when being flush with each other, 0.3 cc of substance (eg, fluid) is discharged.

  Maximum displacement of the lever arm 320 that is adjustable and actuates the pusher 308 to move the plunger 208 within the syringe barrel 204 by a specific distance that can be defined, for example, based on the position of the lever stop member 332 Can be converted into a known, similarly reproducible volume of the substance or material that is expelled from the syringe as described above, which allows the user to obtain a desired, predetermined or predetermined amount. Or it may be possible to repeatedly deliver a volume of material (eg a fluid such as a paralytic drug) to the patient. This can, for example, obtain the resulting symmetry or enhance the user's or operator's ability to deliver the desired agent symmetrically over an area.

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

  An example of a claw release mechanism that releases the claw and resets the pusher 308 with respect to the claw release described above is shown schematically in, for example, FIGS. 7D-7F and generally indicated by reference numeral 350. . Referring to FIG. 7D, the release mechanism 350 includes a push button 354, an opening cylinder 351 that the push button moves to cooperate with the claw slopes or wedge portions 343a, b of the claws 342a, b, and the cylinder 351 with the claws 342a, An urging mechanism such as a coil spring 352 that urges away from b is generally provided.

  The push button or actuator 354 is a hollow cylindrical member having a closed end 354a and an open end 354b. The push button 354 is rotatably and slidably attached to the shaft 336 so that the lever arm 320 is shown schematically in FIG. 7E, schematically showing the push button and lever arm of FIG. 7D from the opposite side. A slot or window 356 extending therethrough is formed. The notch of the push button 354 forming the slot 356 has an upper edge 356a, a lower edge 356b, and side edges 356c, d. FIG. 7F schematically shows a cross-sectional view of the push button and lever arm of FIG. 7E and the upper and lower edges 356a and 356b of the slot. The width “w” of the slot 356 is sized so that when the lever arm 320 is depressed or released, it can travel its intended or desired distance or stroke. The length “I” of the slot 356 is sized to allow the push button 354 to move and slide about the lever arm 320, so that the push button is pushed to release the pawl and its inactive It may be possible to return to position.

  The push button 354 may also extend across the shaft 336 through the opening in the ratchet housing sidewall 314b, for example as shown in FIG. 7D, where it engages the coil spring 352 and moves back and forth within the opening in the sidewall. it can. The coil spring 352 surrounds the shaft 336 and has one end that contacts the pawl support 340 and the other end that contacts the annular edge surface at the opening end of the push button 354. Thus, the coil spring 352 urges or pushes the push button 354 toward its starting or non-actuated position, for example as shown in FIG. 7D. An open cylinder 351, which can be a shallow cylinder as shown, includes a cylindrical wall 351a having an open end and an annular wall portion 351b at the other end. The annular wall portion 351b has a central opening through which the push button 354 extends and is secured as indicated by reference numeral 353. A fixed connection between the annular wall portion 351b and the push button 354 is applied continuously, for example over 360 degrees or less than 360 degrees, or applied discontinuously in a spaced pattern, This can be done by any suitable means such as an adhesive or glue. The spring 352 pushes the push button 354 away from the claw support 340, and the spring 352 pushes the annular wall portion 351 b of the cylinder 351 against the housing side wall 314 b through the push button 354. In this way, the operator can push the button 354 toward the nail support 340 to push the nail radially inward and then release the push button 354 so that the push button 354 is shown in FIG. It can be returned to its non-actuated position as shown and generally indicated by reference arrow 358. The claws 342a, b are made to include beveled or wedge portions 343a, b that form part of the claws 342a, b. The bevel or wedge portion 343a, b has a tapered structure with one side inclined radially inward and is shown schematically in FIG. 7D so that the cylinder 351a engages the bevel or wedge portion. Then, the claws 342a and b are moved inward in the radial direction. The illustrated tapered structure or beveled side that forms the bevel can extend the length of the bevel or wedge portion 343a, b, for example, along the distal end of the nail, the distal end of each nail. Or it can extend a short distance from the free end, or it can extend from the distal or free end of the nail near the pivot pin, or a different distance. However, the bevel or wedge portions 343a, b can be angled, configured and / or arranged differently than those shown to cooperate with the cylinder 351, thereby allowing those skilled in the art to do so. It will be appreciated that when the cylinder 351 is pushed against such a bevel or wedge portion toward the pawl support 340, the pawls 342a, b are moved radially inward.

  Referring to FIG. 7D, if the user desires to reset the pusher 308, the user presses the push button 354 to move the open end of the cylindrical member 351 facing the nail support 340 toward the nail 342a, b. . When the open end of the cylindrical wall 351a engages the claw bevel or wedge portions 343a, b, the bevel portions 343a, b or the claws 342a, b are pivoted as shown schematically in FIG. 8D. Push inward in the radial direction. In this position, the user can reset the position of the pusher 308. It should also be understood that other release mechanisms can be used. After resetting the pusher 308, the push button 354 may be released to allow the pawl to re-engage with the ratchet gear 316.

  The following example is set forth to illustrate one method of operation of the invention and is not intended to limit the scope of the invention. For example, the methods described below are disclosed in connection with treating facial wrinkles or lines, but are not intended to be limited to such treatments. More specifically, the following example applies a liquid filler or numbing agent to facial lines or wrinkles to numb the selective muscles of the face to provide line and wrinkle reduction and smoothing. With injection. The infusion can be repeated to treat other lines or wrinkles or to add more liquid filler to the treated lines or wrinkles.

  The syringe 200 containing the paralytic drug as described above can be prepared to evacuate the interior before being attached to the syringe actuator 300 as described above, or using the syringe actuator 300. A syringe can be prepared for use. When the syringe actuator 300 is used to prepare the syringe for use, the syringe 200 can be secured to the syringe actuator 300 and the device held so that the syringe needle 202 extends upward. The syringe actuator 300 is then actuated by pressing the lever arm 320 (eg, with an index finger) to advance the pusher portion or arm 309 to the syringe proximal end or thumb portion 212 of the syringe plunger 208. When not engaged (FIG. 2), it is further actuated by contacting and then further depressing the lever arm 320 to advance the syringe plunger 208 within the syringe barrel 204, as shown in FIG. A first small amount of material (eg, a droplet of material “d”) can be dispensed to prepare the syringe for use. FIG. 3 shows a lever arm 320 that is only partially depressed to dispense a small amount of material.

  The device 300 is not used to prepare a syringe for use (eg, the syringe was prepared before being secured to the syringe actuator 300) or the pusher extension 309 is a syringe thumb actuator If not engaged with portion 212 (FIG. 2), lever 302 is depressed to engage pusher 308 and thumb actuator portion 212, and then release lever 302 as shown in FIG. It is possible to return to its starting position or stationary state.

  With the hand-held system 100 ready for use, the operator or physician can place the system 100 in the crotch of the finger of the physician or operator's hand, as shown schematically in FIG. The system is held with one hand in the received state between the thumb, forefinger and forefinger on lever portion 321. The middle finger can provide additional support for holding the device 300. The operator or physician uses the other hand to hold the patient's skin and stretch the skin in the area of the facial lines or wrinkles to assist in proper placement of the syringe needle and delivery of the agent. The operator or physician then advances the dispensing device 100 toward the target site on the patient's skin as shown by arrow 102a in FIG.

  Referring to FIG. 5, after the operator or doctor has inserted the syringe needle 202 into the patient's skin, the lever arm 320 is sufficiently depressed to engage the set screw or stop member 332 of the lever stop 328. , Move the pusher 308 and syringe plunger 208 as desired (or a predetermined and / or predetermined distance) to deliver the desired (or predetermined and / or predetermined) amount (or volume, dose or dose) of the paralytic agent. Inject into the muscle under the facial line or wrinkle to be treated.

  FIG. 6 shows the dispensing device 100 after the syringe needle 202 has been withdrawn from the patient and the lever arm 320 has been released allowing it to return to its starting position as shown in FIG. The operator or physician can then penetrate the needle to another site to treat other lines or wrinkles, or add more liquid filler to the treated lines or wrinkles, This can be repeated until the syringe is empty or no more desired (or predetermined and / or predetermined) amount (or volume, dose or dose) of substance or paralytic agent is contained. Next, the syringe 200 is removed from the syringe actuator 300, the pusher 308 is reset, and another syringe containing the desired paralytic drug is attached to the device 300 to continue the patient's treatment or treat a different patient. be able to. In addition, the stop member or set screw 332 of the stop 328 may be adjusted after any injection and at any time during the treatment at the desired amount (or volume, dose or dose), or the desired (or default) And / or a predetermined) amount (or volume, dose or dose) of the injected agent can be altered or varied.

  FIG. 10 shows another variation of the dispensing unit 100 that is configured to generate a negative pressure in the reservoir prior to delivering the contents of the substance in the barrel or reservoir 204. The illustrated variation is also shown with the internal features of device 100 without any outer cover or housing for clarity. However, any number of covers, shells, ergonomic fittings, etc. may be provided in the illustrated exemplary device. As described below, many variations of the device include a cover that allows a health care provider to administer the device using one hand. Also, the discharge unit incorporates additional features such as a feedback sensor or other circuitry that can allow for the provision of current through the needle of the syringe or the electrodes connected to the needle and / or syringe. Can do.

  As shown, the dispensing unit 100 includes a syringe 200 that is coupled to the device 100. In the illustrated example, the syringe 200 is releasably coupled to the dispensing unit 100 via one or more coupling or securing mechanisms 304, 306. Any number of securing mechanisms can be used in unit 100. Further, alternative variations of the dispensing unit 100 can include a syringe that is built into or integrated with the dispensing unit.

  The device 100 shown in FIG. 10 includes an actuator 230 that is mechanically coupled to a first gear 232 and a second gear 236 via respective first and second shafts 234 and 238. (In FIG. 10, the second gear and the second shaft are positioned behind the guide member 240). A further variation of the device 100 allows a care provider to grip the device with the thumb and middle finger while operating the actuator 320 with the index finger. Thus, the housing (not shown) can be configured to aid in such handling. Further, in many variations of the device 100, the actuator 230 extends toward the discharge end (eg, toward the end of the device cannula / needle 202). This structure provides the user with the ability to grip the body or device with the index and middle fingers and actuate the lever 230 with the index finger. Obviously, other retaining structures are within the scope of alternative variations of the device of the present disclosure. However, the stability of the device (when inserted into the tissue) increases when the index finger applies pressure to the lever 230 and the contact point 231 moves through an arc or path close to where the operator grips the unit. To do.

  FIG. 10 also shows the plunger 208 of the syringe 200 connected to a plunger fitting 242 that connects the plunger 208 to a lever via a gear system. Accordingly, the plunger fitting 242 moves the plunger upon actuation of the gear drive assembly triggered by the actuator 230. As shown, the plunger fitting 242 can also include various keys and channels 242 to allow for smooth advancement of the plunger 208.

  The gear of this embodiment is shown as a rack in pinion gear having a first rack gear 250 that moves the plunger 208 in the forward direction and a second rack gear 252 that moves the plunger 208 in the backward direction. ing.

  11A and 11B show a front view and a rear view, respectively, of the device 100 of FIG. The lever 230 and the guide member 240 (not shown) are hidden from view in FIGS. 11A and 11B to better illustrate the drive mechanism of the illustrated variant, and the drive mechanism causes the plunger to move when the lever actuator 230 moves. Move. As can be seen in FIG. 11A, the first drive gear 232 engages the first rack gear 250. The first drive gear 232 rotates according to the rotation of the first shaft 232. FIG. 11B shows the opposite end of the first shaft 232 connected to the drive lever 244. The illustrated variant also includes a rear drive gear 238 that is fixed to the rear drive shaft 236. The rear drive shaft 238 moves when the rear drive pulley 254 rotates.

  A variation of the device allows movement of the plunger 208 in a first direction followed by a second direction using a single stroke of the lever 230. Typically, the movement in these two directions creates a negative pressure in the reservoir, which causes the healthcare provider to place the needle on the patient so that blood or other fluid is drawn into the reservoir or window 203 of the device 100. Allows insertion and then activation of device 100. In certain cases, such as those described above, the health care provider attempts to verify the placement of the needle in muscle or other tissue rather than blood vessels. If the care provider determines that the needle is desirably placed through this check process, the care provider can continue to administer the infusion. One advantage of performing these two actions in a single stroke is that the needle 202 can remain stationary. This can cause the needle to shift inadvertently, thereby reducing the risk that the infusion will be delivered to an unwanted area of the body.

  FIG. 11B shows an example where the stroke of the lever 230 can include one or more segments 110 and 112 to allow the direction of the plunger 208 to be reversed. It is noted that the length of segments 110 and 112 can be adjusted as desired, and that the segment lengths shown are for illustrative purposes only.

  FIGS. 12A-12E illustrate an example of a gear drive assembly during movement of the actuator 230 through the first stroke segment 110. FIG. 12A shows the rest or initial position of the lever 230. It is noted that the lever and other components of the system 100 and / or the drive assembly can be spring biased to allow the gear / actuator / etc. To return to the initial position. Continued movement of the lever 230 in the direction 150 as shown in FIG. 12B causes the rear drive pulley 254 to rotate in the direction 152 relative to the rear drive lever 248. The rear drive pulley 254 is connected to the rear drive shaft 238 (shown in FIG. 11A) and rotates the rear drive gear 236 to move the plunger connection 242 rearward in the direction 154. In the illustrated example, the rear portion 231 of the lever 230 is not yet engaged with the main drive lever 244. When 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 231 of the lever move in the direction 156. However, the main drive shaft 234 can use a one-way clutch so that movement of the main drive lever 244 in the direction 156 does not produce movement of the main gear drive 232. This clutch is necessary because the rear movement of the main rack gear 250 is caused by the rearward movement of the plunger attaching portion 242.

  FIG. 12D shows the continued movement of the lever 230 and the rotation of the rear drive gear 236 and the rear drive shaft 238 to continue the movement of the plunger connection 242 in the rear direction 154. FIG. 12E shows a situation where the movement 150 of the lever 230 reaches the second segment 112. In this state, as shown in FIG. 12F, the rear drive surface 246 of the rear drive lever 248 is detached from the rear drive pulley 254 by the movement 150 of the lever 230 to the second segment 112. In the illustrated example, the slot 256 positioned on the rear drive lever 248 allows movement of the rear drive surface 246 away from the rear drive pulley 254. However, any number of structures (such as cam / follower design, undulating design, etc.) can be used to prevent movement of the rear drive pulley 254. Returning to FIG. 12E, movement of lever 230 through segment 112 causes main drive lever 244 to continue to move in direction 156, causing first or main gear 232 to rotate in direction 162, resulting in (FIG. 11A Since the main gear 232 engages the first rack gear 240 (as shown in FIG. 1), the plunger connection 242 advances.

  The disengagement prevents the rearward movement of the plunger fitting, and the continuous movement of the lever 230 through the second segment 112 causes the first gear 232 and the first shaft 234 to move, which ultimately results in the plunger fitting and The plunger is moved forward to push the substance located in the reservoir or barrel. Again, the position of the lever 230 is provided for illustrative purposes only, and the arc lengths of the first segment 110 and the second segment 112 depend on the amount of negative pressure and the amount of fluid delivery required. Can be adjusted based on. Further, the gear ratio can be adjusted as necessary to obtain the desired displacement or movement of the plunger fitting.

  In the sequence described above, the first segment 110 corresponds to a check and the second segment corresponds to the delivery of a substance. Obviously, if the health care provider observes the presence of blood (or any other bad situation) and injects the substance and attempts to avoid the muscles, it releases the actuator 230 and the system , Can return to the rest or initial position shown in FIG. 12A. Alternatively, an infusion system can be used to confirm the delivery of the substance into the blood vessel, in which case a check can be used to confirm the placement of the needle within the blood vessel. The present disclosure includes any number of changes in the use of the system that allows movement of the plunger in two directions while minimizing needle movement and / or with a single stroke of the actuator.

  FIG. 13 shows a bottom view of the variant shown in FIG. The illustrated view shows an optional lockout feature 258 having one or more surfaces 260 that can engage a portion of the rear drive lever 248 (in this example, a lockout feature). The feature 258 engages one or more pins 262 of the rear drive lever 248). In the illustrated example, the lockout feature 258 can be advanced in the direction 158 to engage the rear drive lever 248 and disengage the device from performing the checking function.

  14A-14C illustrate the movement of the actuator 230 that advances the plunger fitting 242. The illustrated example reveals the device when the release feature 258 separates the rear drive lever 248 from the rear drive pulley 254. However, the same principle applies when the rear drive arm 248 is detached from the rear drive pulley 254 when the actuator 230 enters the traveling second segment 112 as described above.

  FIG. 14A shows the device 100 when the lever 230 is in the rest or initial position and can move in the direction 164. As shown in FIG. 14B, when the lever 230 moves in the direction 164, a portion of the actuator engages the lever arm 248 and moves the lever arm in the direction 156. Because there is no opposite movement caused by the rear drive pulley 236, the main gear 232 moves in the direction 162 and engages the main rack gear 252 of the plunger fitting 242 to move the plunger fitting 242 in the direction 160. This also moves the plunger 208 as shown. FIG. 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 can be varied as needed. Some variations 100 of the present invention are provided by one or more springs 266 that allow the main lever 230 to return to the initial position shown in FIG. 14A upon removal of the force applied to the lever 230. Including a spring reset feature. The spring reset feature also returns the lever arms 248, 244 to their rest position. In the illustrated example, the spring 266 moves the actuator 230 in the direction 166, where the slot feature can return the rear drive lever 248, and the second spring (not shown) moves the lever in the direction 168. Help move 244.

  The present disclosure contemplates any number of variations and modifications of the devices shown herein that allow for two movements of the plunger when delivering a substance. For example, FIG. 15A shows an alternative design in which the actuator 230 moves the barrel 204 in the direction 170 while stably holding the plunger 208, this relative movement being negative pressure within the barrel 204. Generate a check function. FIGS. 15A and 15B show one example of a structure that provides this relative movement, in which case the actuator 230 keeps the barrel 204 stable while during the initial movement of the lever 230. Because it includes a first slot 270 and a second slot 272 that advance the barrel 204 and then advance the plunger 208, the plunger is advanced in direction 160 to expel the contents of the syringe 204.

  FIG. 16 shows another variation of the components used with the infusion system described herein, as shown, where the unit 100 is optional for any one-hand administration of the device. A type of outer cover 280 or housing may be included. For illustrative purposes, the housing 280 is shown without a top cover. Further, the housing 280 may sense through any power source, electrical contact, memory, or cannula 202 and / or any number of electrodes 286, 288 disposed on or within the cannula 202. A processor (as indicated by 282) that can be included. The circuit portion 282 can be coupled to the needle / electrode 284 using any conventional conductive member 284.

  FIG. 17A shows a perspective view of another example of a dispensing unit 100 having a modified housing 420 that enhances the user's ability to dispense positioning and actuation of one hand of the unit 100. The illustrated example also shows a plunger 208 that is slidable relative to the barrel 204 of the syringe 200 positioned within the housing 420.

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

  As described below, the housing shown in FIG. 17A is designed with features that enhance the ability of a healthcare provider to provide metered infusion.

  FIG. 17B shows a top view of the unit 100 of FIG. 17A. As shown, the unit's gear assembly and syringe can be positioned within the window 424 of the housing 420. In the illustrated variation, the window 424 is exposed along an upper loading surface 422 that allows the syringe 200 to be loaded into the gear assembly. In the illustrated variation, the loading surface 422 and the window 424 allow sufficient room for positioning the syringe 200 within the housing 420 so that the syringe and plunger can be coupled to appropriate portions of the mechanism. . In the illustrated variation, the window 424 exposes the drive assembly, such 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. Allows insertion of the syringe into the housing, aligned with the longitudinal axis. 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 can be closed by one or more covers.

  FIG. 17C shows a bottom view of the housing 420 to show the bottom base surface 426, which is stationary and in a stable position when positioned on the outer surface. This base surface 426 allows the user to maintain the stability of the housing when the syringe is joined or otherwise coupled to the unit through the window 424 of the loading surface 422.

  FIG. 17D shows a side view of the housing 420 of FIG. 17A, showing the support side 430 of the housing 420 and a plurality of recesses that aid in one-handed operation of the device. For example, the housing 420 includes at least a base recess 432 positioned on the base surface 426. As described below, the base recess 432 allows for nest of the crotch of the finger behind the user's hand inside. The base recess 432 also allows application of force in the direction of injection (towards the needle 202) and thus also a directional force surface 434 that reduces the gripping strength or force required to advance the needle 202 to the target tissue. Can be included. Without the directional force surface 434, the user must increase the compressive force on the housing via the user's finger to push the needle into the tissue.

  FIG. 17D also shows a support recess 436 positioned on the support surface 430, which receives the thumb of the user's hand. FIG. 17E shows an opposite view of the device showing the lever side 228 with the lever recess 438 extending from the base 426 to the distal end of the body 420. The lever recess 438 allows the user's index or middle finger to house / control the device with one hand when the user operates the lever 320. The lever recess 438 also helps to maintain the index finger with a relatively straight profile. The body 420 can further include a distal or indicator recess 440 positioned on the lever side 428 and adjacent to the loading surface 422. The distal / indicator recess 438 allows the body 420 to be balanced by the nesting of the user's middle finger when the user's index finger engages the actuator 320. As shown below, the support recess 436 and the base recess 432 allow the body 420 to be nested in the crotch of the finger on the back of the user's hand, while the distal recess 440 allows the user to It is possible to maintain the force on 428.

  18A and 18B show an example of how the housing 420 of FIGS. 17A-17E facilitates one-handed operation of the infusion unit. As shown, the user can position the base recess 432 by the crotch 4 of the user's hand 2 while extending the thumb 6 along the support recess 434. As noted above, the base recess 26 also includes a distal force surface (not shown in FIG. 18A or 18B). The user's hand (especially the area adjacent to the palm or thumb base) can be used to apply a force in the direction of the needle or a force distally to push the needle into the tissue. This surface reduces the need for the user to apply an increased compressive force on the side of the housing and push it forward. FIG. 18B shows the lever side 428 of the housing 420 where the middle finger 10 of the user's hand 2 is on the lever side and engages the distal recess 440 adjacent to the loading surface 422. The distal recess 440 allows the user to apply a stabilizing force against the side of the device opposite the thumb using the middle finger 10. As shown, the index finger 8 engages the actuator 320 to operate the device. FIG. 18B also shows that the base surfaces 426 on either side of the base recess 432 provide additional surface area to the user to support the housing by using the remaining fingers 12 at the distal portion of the device or at the back of the device. Show.

  As explained above, the structure of the housing 402 allows the unit to be held and used with one hand (eg, in a manner similar to holding a pen, or the thumb and the first two fingers). Facing forward or distal). Holding the device using such positioning can increase the controllability and stability of the system in use. In addition, one-handed operation of the system allows the user (eg, operator or doctor) to do something else with their free hands. For example, when treating wrinkles using the system, one-handed operation allows the user's free hand to hold the patient's skin and stretch the skin in the wrinkled area, which is delivered Facilitates proper placement of the active agent with the other hand. The illustrated housing structure also provides a surface that is oriented for improved manipulation to the desired site and improved penetration of the syringe needle into the tissue.

  19A-19C show various views of another variation of the housing 420 in which various marked portions of the housing are intended for engagement by a user's hand or finger. For example, FIG. 19A shows lever 320 and distal recess 440 as marked in a visually apparent manner or via tactile sensation. 19B and 19C illustrate an example where the distal recess 440 and the support recess 436 are marked and / or identified.

  FIG. 20 can be used with the infusion system described herein or as a stand-alone improvement to a conventional infusion device that gives the care provider the ability to determine the type of tissue prior to infusion. It shows another related concept that can be. As shown, the sensing fitting 380 can include a hub 382 that receives a commercially available syringe, fitting, luer, etc. in the opening 383. The hub 382 can include a conductive cannula 384 and / or one or more electrodes 386,388. The cannula 384 (and / or electrode) can be coupled to a fitting 390 shown as being on the hub 382 of the device 380 (but can be located anywhere including distal to the fitting 380). ), The fitting allows sensing fitting 380 to be coupled to power supply / processor / user interface unit / etc. 394. Unit 394 may include any number of user feedback signals, such as audible, visual, graphical display, etc. Unit 394, when inserted into tissue, can specify whether the care provider has placed a needle on the skin, muscle, fat, blood vessel, or the like. As noted above, the needle is in monopolar mode (requires the use of a ground electrode 396) or bipolar mode using two electrodes in combination with the needle or using only two electrodes. Can be used as part of the path.

  Sensing unit 380 can be used when a care provider must deliver an infusion to a particular tissue (eg, blood vessels, skin, fat, muscle, etc.). The conductive needle 384 (and / or electrode) can provide current to identify the type of tissue by any known identification mode of such tissue.

  FIG. 21 illustrates yet another embodiment for use with the infusion system described herein or any stand-alone infusion system. FIG. 21 shows a holding unit 400 having an area 402 to receive any type of commercially available vial 402 containing a drug. The loading unit 400 includes one or more ports 406 for inserting a needle to draw a substance into a syringe of an injector (not shown). The holding unit 400 is typically coupled to a power source (AC or DC power source) that allows the holding unit 400 to maintain the drug / substance 404 at a desired temperature. Alternatively, the holding unit 400 can be used to heat or cool the substance 404 without requiring any power source 410 (such as dry ice, freon, ice, cold water, hot water, etc.). ) Substances can be included.

  Accordingly, the retention unit 400 can include a user interface 408 that provides audible, visual and / or graphic information regarding the temperature of the substance and additional information such as time, batch, drug type, and the like. The discharge unit 400 can be fixed to a wall, a cart, a table, or the like. Alternative variations include a portable desktop structure.

  In one example, the dispensing unit shown in FIG. 18 can be used to administer Botox, Xeomin or any similar substance. Such materials are usually reconstituted from a dry fat-soluble state. Such a material, when reconstituted, becomes less effective over a time proportional to its temperature. Standard practice involves storing the reconstructed Botox at a standard temperature of 35 degrees Fahrenheit. The holding unit 400 can prevent having to come and go to the freezer / refrigerator when administering. Instead, the holding unit 400 can maintain the vial at the desired temperature and allow the care provider to repeatedly access the material to administer the infusion.

  Another additional advantage of the holding unit 400 is that the care provider can load the syringe without holding the vial 404 because the vial is temporarily secured within the holding unit 400. .

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

  Variations and modifications of the devices and methods disclosed herein will be readily apparent to those skilled in the art. Accordingly, the foregoing detailed description and accompanying drawings are provided for clarity and understanding and are not intended to limit the scope of the invention which is defined by the claims appended hereto. I want you to understand.

  Although the methods and devices of the present invention have been described with respect to the above-described embodiments, many variations and / or additions to the preferred embodiments described above will be readily apparent to those skilled in the art. It is intended that the scope of the invention covers 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 discharge unit for use with a syringe, the syringe having a barrel and a plunger slidable relative to the barrel to discharge a substance located in the barrel, the medical discharge system Is:
A housing assembly configured to secure the barrel of the plunger such that a distal end of the barrel is adjacent to a distal end of the housing assembly;
A drive mechanism coupled to the housing assembly, the drive mechanism comprising a plunger fitting engaging the plunger;
An actuator; and a gear drive assembly coupled between the plunger fitting and the actuator, wherein the gear drive assembly moves in response to movement of the actuator, and in a rearward direction with respect to the distal end of the housing; The plunger fitting is configured to generate a movement of the plunger fitting in a forward direction opposite to the backward direction, and the actuator moves in one continuous direction to move the plunger in the backward direction and the forward direction. A discharge unit comprising a gear drive assembly for generating a movement of   The discharge unit of claim 1, wherein the gear drive assembly moves the plunger fitting in the rearward direction and then in the forward direction in a single stroke of the actuator.   The discharge unit of claim 1, wherein a portion of the gear drive assembly is detachable so that the plunger fitting moves in the forward direction in a single stroke of the actuator. The gear drive assembly is configured to generate at least a first gear structure configured to generate movement of the plunger fitting in the rearward direction, and to generate movement of the plunger fitting in the forward direction. Comprising a second gear structure configured,
A single stroke of the actuator includes a first segment and a second segment, and movement of the actuator in the first segment moves the first gear structure, and the actuator in the second segment The discharge unit according to claim 1, wherein the second gear structure moves by movement of the first gear structure.   5. The discharge unit of claim 4, wherein the gear drive assembly disengages the first gear structure during movement of the actuator in the second segment.   The discharge unit according to claim 4, wherein the first gear structure includes a rack and pinion assembly.   The discharge unit according to claim 4, wherein the second gear structure includes a rack and pinion assembly.   The first gear structure is releasably coupled to the actuator by a first shaft, whereby movement of the actuator from the first segment to the second segment results in the first shaft. The discharge unit according to claim 4, wherein the actuator is disconnected.   The discharge unit according to claim 4, wherein the second gear structure is separated from the actuator until the actuator moves through the first segment.   The discharge unit according to claim 4, wherein the second gear structure is connected to the actuator by a second shaft.   The discharge unit of claim 1, wherein the actuator is coupled to a first shaft that is rotatable relative to the housing assembly, and a portion of the first shaft is coupled to the gear drive assembly.   The discharge unit of claim 11, wherein the first shaft is positioned proximate to the barrel. Dispensing unit:
A syringe having a barrel and a plunger slidable relative to the barrel to discharge a substance located in the barrel;
A housing assembly configured to secure the barrel of the plunger such that a distal end of the barrel is adjacent to a distal end of the housing assembly;
A drive mechanism coupled to the housing assembly, the drive mechanism comprising a plunger fitting engaging the plunger;
An actuator; and a gear drive assembly coupled to the plunger fitting and the actuator, wherein the assembly moves in response to movement of the actuator, and in a rearward direction and then in a forward direction with respect to the distal end of the housing. Configured to generate movement of the plunger fitting, the movement of the plunger fitting in the backward direction and the forward direction comprising a gear drive assembly that occurs during movement of the actuator in a single direction; Discharge unit. A method of injecting a substance into a patient comprising:
Positioning a syringe adjacent to the patient's tissue site, the syringe having a plunger coupled to a barrel and a cannula extending from the barrel;
Advancing the cannula into the tissue site;
Activating a drive mechanism coupled to the syringe, wherein the drive mechanism moves the plunger and the barrel in a first direction relative to each other upon actuation of the actuator of the drive mechanism in a single direction. And subsequently operating, wherein the method is configured to move in a second direction opposite to the first direction.   15. The method of claim 14, further comprising disengaging a first portion of the drive mechanism to prevent movement of the plunger in the first direction upon a single actuation of the drive mechanism.   Partially engaging the second portion of the drive mechanism by actuation of the actuator in the single direction so that the second portion of the drive mechanism is the plunger and the The method of claim 14, further comprising moving and engaging barrels in the second direction relative to each other.   Actuation of the drive mechanism in the single direction includes a first segment and a second segment, and the method includes the second segment of actuation in the single direction or the single segment. 15. The method of claim 14, further comprising observing the barrel for blood volume prior to the second segment of direction actuation.   The method of claim 14, wherein actuation of the drive mechanism in the single direction includes a first segment of travel and a second segment of travel of the actuator.   18. The method of claim 17, further comprising observing the barrel for blood volume when or before the actuator enters the second segment of progression.   The method of claim 17, wherein the syringe dispenses a predetermined amount of the substance during the second segment of travel of the actuator.   20. The method of claim 19, further comprising adjusting the drive mechanism to adjust the predetermined amount of the substance.   Maintaining the cannula and actuating the drive mechanism to move the plunger and the barrel relative to each other in the first direction and then in the second direction without moving the cannula; 15. The method of claim 14, comprising. A method of administering an infusion of a substance to a patient comprising:
Positioning an infusion device adjacent to the patient's tissue site, the infusion device having a reservoir having a plunger slidable therein and a cannula extending from the barrel;
Advancing the cannula into the tissue site; and actuating a lever with one hand, first increasing the volume of the reservoir relative to the plunger and subsequently decreasing the volume of the reservoir relative to the plunger Delivering the substance into the patient. A device that delivers an infusion of a substance into a tissue region comprising:
A reservoir configured to hold the substance;
A plunger coupled to the reservoir, wherein the plunger changes volume by movement of the plunger;
A cannula fluidly coupled to the reservoir at a distal end, the cannula configured to penetrate the tissue region;
An actuator mechanically coupled to the plunger, the actuator being configured to move from a rest position to a delivery position, wherein partial movement of the actuator from the rest position in the first direction; A continuous movement of the actuator in the same direction toward the delivery position that generates a movement of the plunger generates a movement of the plunger in a second direction, the first direction being different from the second direction The device comprising an actuator that is the opposite. A discharge unit for use with a syringe, the syringe having a barrel and a plunger that is slidable relative to the barrel and discharges a substance located in the barrel, the medical discharge system Is:
A housing assembly configured to secure the barrel of the plunger such that a distal end of the barrel is adjacent to a distal end of the housing assembly;
A drive mechanism coupled to the housing assembly, the drive mechanism comprising a plunger fitting engaging the plunger;
An actuator configured to move in a single direction of travel including a first stroke segment and a second stroke segment; and a gear drive assembly coupled between the plunger fitting and the actuator. Moving in response to movement of the actuator in a first direction relative to the distal end of the housing during the first stroke segment and subsequently during the second stroke segment. A discharge unit comprising a gear drive assembly configured to generate movement of the plunger fitting in a second direction opposite to the one direction.   26. A dispensing unit according to claim 25, wherein a portion of the gear drive assembly is detachable so that the plunger fitting moves in the forward direction in a single stroke of the actuator. The gear drive assembly is configured to generate at least a first gear structure configured to generate movement of the plunger fitting in the rearward direction, and to generate movement of the plunger fitting in the forward direction. Comprising a second gear structure configured,
A single stroke of the actuator includes a first segment and a second segment, and movement of the actuator in the first segment moves the first gear structure, and the actuator in the second segment 26. The discharge unit according to claim 25, wherein the second gear structure moves by the movement of.   28. A dispensing unit according to claim 27, wherein the gear drive assembly disengages the first gear structure during movement of the actuator in the second segment.   The first gear structure is releasably coupled to the actuator by a first shaft, whereby movement of the actuator from the first segment to the second segment results in the first shaft. 28. The discharge unit of claim 27, wherein the actuator is decoupled. A dispensing unit for use with a syringe and configured to allow delivery of an infusion by one-handed actuation by a user, wherein the syringe cannulates a barrel and a substance located within the barrel Having a plunger slidable relative to the barrel for discharge through, the discharge unit comprising:
A housing to which a drive mechanism is coupled, the drive mechanism comprising an actuator that moves the gear assembly to advance the plunger fitting;
The housing includes a loading surface, a base surface, a lever side and a support side:
The loading surface includes a window that exposes the drive assembly such that a distal end of the barrel is adjacent to a distal end of the housing and the cannula extends beyond the distal end of the housing. And allowing the syringe to be inserted into the housing in alignment with the longitudinal axis 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 stationary position when positioned on the outer surface, allowing the housing to maintain stability when connecting the syringe through the window. ;
At least a plurality of recesses having a contoured shape on the housing, the base recess being located on the base surface, and a support extending from the base recess toward the distal end of the housing along the support side Including at least a plurality of recesses, including the recesses,
The support recess and the base recess are arranged so that the thumb and dorsal side of the user's hand are positioned while the index finger is engaged with the actuator and the index finger is directed toward the distal end when moving the actuator. Dispensing unit positioned to allow nesting of each finger crotch.   The discharge unit according to claim 30, further comprising an indicator that is positioned in at least one of the plurality of recesses and enables identification of the recesses.   32. A dispensing unit according to claim 31, wherein the indicator includes a tactile or visual indicator.   The support recess includes at least one directional force surface substantially transverse to the longitudinal axis of the housing so that the user can insert or remove the cannula from the patient. The discharge unit according to claim 30, wherein a force perpendicular to the directional force surface can be applied.   31. A lever recess extending from the base recess along the lever side toward the distal end of the housing, wherein the lever recess allows for the insertion of an index finger on the actuator side of the housing. The discharge unit described.   35. The discharge unit of claim 34, further comprising an indicator positioned in the lever recess and enabling identification thereof.   The lever recess includes at least one directional force surface substantially transverse to the longitudinal axis of the housing so that the user can insert or remove the cannula from the patient. The discharge unit according to claim 30, wherein the discharge unit can be pushed and pulled with respect to the directional force surface.   Further comprising an index recess positioned on the actuator side of the housing and adjacent to the distal end, the index recess allows further finger end nesting and further stabilizes the housing during movement of the actuator The discharge unit according to claim 30.   38. The discharge unit according to claim 37, further comprising an indicator positioned in the index recess and enabling identification thereof.   31. A discharge unit according to claim 30, further comprising a cover on the window of the loading surface, the cover being removably coupled to the housing.   The discharge unit of claim 30, further comprising an operating surface coupled to the actuator.   41. The discharge unit according to claim 40, further comprising an indicator positioned on the working surface and enabling identification thereof.   The drive assembly is a gear drive assembly coupled between the plunger fitting and the actuator and moves in response to movement of the actuator and in a first direction relative to the distal end of the housing. 31. The dispensing unit of claim 30, further comprising a gear drive assembly configured to generate movement of the plunger fitting in a second direction that is subsequently opposite to the first direction.   The drive assembly is a gear drive assembly coupled to the plunger fitting and the actuator, the drive assembly moving in response to movement of the actuator, and in a first direction relative to the distal end of the housing. 32. The discharge unit of claim 30, further comprising a gear drive assembly configured to generate movement of the plunger fitting in a second direction opposite to the first direction.   31. A dispensing unit according to claim 30, wherein the gear drive assembly moves the plunger fitting in the first direction and then in the second direction in a single stroke of the actuator.   31. A dispensing unit according to claim 30, wherein a portion of the gear drive assembly is detachable so that the plunger fitting moves in the second direction in a single stroke of the actuator. The gear drive assembly includes at least a first gear structure configured to generate movement of the plunger fitting in the first direction, and movement of the plunger fitting in the second direction. A second gear structure configured to generate,
A single stroke of the actuator includes a first segment and a second segment, and movement of the actuator in the first segment moves the first gear structure, and the actuator in the second segment The discharge unit according to claim 30, wherein the second gear structure moves by movement of the first gear structure.   The discharge unit of claim 46, wherein the gear drive assembly disengages the first gear structure during movement of the actuator in the second segment.   The discharge unit of claim 46, wherein the first gear structure includes a rack and pinion assembly.   The discharge unit of claim 46, wherein the second gear structure includes a rack and pinion assembly.   The first gear structure is releasably coupled to the actuator by a first shaft, whereby movement of the actuator from the first segment to the second segment results in the first shaft. 47. The discharge unit of claim 46, wherein the actuator is decoupled.   47. The discharge unit of claim 46, wherein the second gear structure is disengaged from the actuator until the actuator moves through the first segment.   47. The discharge unit according to claim 46, wherein the second gear structure is connected to the actuator by a second shaft.   31. The discharge unit of claim 30, wherein the actuator is coupled to a pivot shaft that is rotatable relative to the housing assembly, and a portion of the shaft is coupled to the gear drive assembly.   54. A discharge unit according to claim 53, wherein the pivot shaft is positioned proximate to the barrel. A method of injecting a substance into a patient comprising:
In a housing having a drive mechanism comprising an actuator for positioning a syringe adjacent to a tissue site of the patient, wherein the syringe moves a gear assembly to advance a plunger fitting coupled to a plunger of the syringe. Fixed to the positioning;
The housing includes a loading surface, a base surface, a lever side and a support side, and at least a plurality of concave portions having a undulating shape on the housing, and the plurality of concave portions are positioned on the base surface. A recess comprising a support recess extending from the base recess toward the distal end of the housing along the support side; and gripping the housing with one hand, thereby providing a thumb and dorsal side of the hand Finger crotches are nested within the support recess and the base recess, respectively, to allow advancement of one hand of the syringe into the patient, and the end of the index finger engages the actuator so that the index finger is Gripping, allowing the actuator to move and perform the injection, allowing it to remain oriented toward the distal end ,Method.

Images