JP6367238B2 - Medication injector - Google Patents

Description

  The present invention relates to a device, such as a syringe or syringe-like device, that allows repeated and accurate dosing of substances such as neurotoxins.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of US patent application Ser. No. 61 / 758,698, filed on May 30, which claims the benefit of priority and is hereby incorporated herein by reference in its entirety.

  Various types of syringes are available for medical (injection, eye drops, etc.) and non-medical (sauce / cooking, gluing, lubrication, other industries / manufacturing). Over the years, the basic syringe has had many enhancements. These include, but are not limited to, syringes pre-filled with unit quantities / aliquots of drugs or other fluids, as well as disposable syringes, syringes including luer locks, safety mechanisms that minimize needle stick accidents And syringes dedicated to medication cartridge systems (such as Carpojects®).

  For most syringes, by applying pressure to the piston and controlling the piston stop location while looking at the scale indicating the delivery volume, the operator can use multiple divided volumes to deliver a predetermined full volume of fluid to the target location. (Equally or non-equally divided) fluids can be administered from the same syringe.

  However, this requires good hand-eye coordination. In certain applications, such as delivering multiple doses of drugs sequentially at the same patient visit, it can be important to deliver a very accurate amount of fluid in a fast, convenient, precise and accurate manner.

  There is a need for a syringe or syringe-like device that allows the substance to be dispensed repeatedly and accurately and allows the operator to focus on other important aspects of the procedure involved.

  A metered multiple dose / dose syringe according to the present invention generally includes a barrel having an open end and opposed spaced ports adapted to receive a needle. A piston is provided slidably disposed within the barrel through the open end of the barrel, and a push rod is connected to the piston for sliding the piston within the barrel.

  In accordance with the present invention, a structure is provided for interconnecting the barrel and push rod to allow the push rod and piston to move in stages within the barrel. The structure further provides tactile and / or audible (acoustic) indications of such stepwise movements so that the user does not see the syringe when delivering multiple doses. To be able to manipulate this.

  Thus, a syringe within the scope of the present invention can act as a physical stop, which can act to prevent fluid from continuing to be delivered by hydraulic momentum after releasing the thumb pressure from the push rod (piston). A dose-controlled indicator (ie, element 58 in FIG. 1, element 22 in FIG. 6, element 138 in FIG. 8, and element 68 in FIG. 10) allows for precise dosing.

  More specifically, a structure according to an embodiment of the present invention may include a plurality of spaced ridges on the outer surface of the push rod and an engageable ridge disposed on the inner surface of the barrel.

  In another embodiment of the present invention, the structure comprises a plurality of spaced detents on the outer surface of the push rod and corresponding engageable ridges disposed on the inner surface of the barrel.

  In yet another embodiment of the present invention, the structure comprises a plurality of spaced ridges disposed on the outer surface of the barrel and an arm connected to the push rod. The arm includes ridges arranged such that spaced ridges engage in stages. More specifically, the spaced ridges may be aligned with each other only about a portion around the barrel, and the width of the arm may be narrower than the periphery of the push rod.

  In yet another embodiment of the present invention, the structure includes a plurality of spaced ridges disposed on the outer surface of the barrel and further provided with a sleeve, the sleeve surrounding the push rod and the spaced ridges being stepped. A ridge disposed on the inner surface of the sleeve for mechanical engagement. More specifically, in this embodiment, the spaced ridges surround the barrel and the sleeve ridges surround the sleeve inner surface.

  A further embodiment according to the present invention is a plurality of spaced detents disposed on the outer surface of the barrel and an arm connected to the push rod such that the spaced detents engage in stages. And a structure including an arm including a ridge disposed on the surface. More specifically, in this embodiment, the spaced detents may be aligned with each other over a portion of the barrel structure, and the width of the arm is narrower than the circumference of the push rod.

  A further embodiment of the present invention provides a syringe, wherein the structure comprises a plurality of spaced detents disposed on the outer surface of the barrel, and the sleeve surrounding the push rod is a stepped spaced detent. A ridge disposed on the inner surface of the sleeve for mechanical engagement. More specifically, in this embodiment, the spaced detents may surround the barrel and the sleeve ridge may surround the sleeve inner surface.

  In another embodiment, the present invention provides a dosing injector that includes a dosing mechanism that allows repeated and accurate dosing of substances such as neurotoxins.

  In certain embodiments, a dosing injector is provided that includes a dosing mechanism that allows a substance to be dispensed repeatedly and accurately and a release mechanism that allows a user to leave the dosing mechanism.

  The advantages and features of the present invention will be better understood when the following description is considered in conjunction with the accompanying drawings.

FIG. 4 is a diagram of a metered multiple dose / dose syringe according to the present invention. The syringe generally includes a barrel, a piston slidably disposed within the barrel with a push rod connected to the piston, and a barrel that allows the push rod and piston to move in stages within the barrel. And, more particularly, the structure includes a plurality of spaced ridges on the outer surface of the piston and an engageable ridge disposed on the inner surface of the barrel. May be included. FIG. 6 illustrates a method of using the present invention with a cystoscope to observe and operate on the bladder while utilizing the tactile and audible mechanisms of the present invention. FIG. 7 illustrates an alternative ridge and detent configuration encompassed by the present invention. FIG. 7 illustrates an alternative ridge and detent configuration encompassed by the present invention. FIG. 7 illustrates an alternative ridge and detent configuration encompassed by the present invention. FIG. 6 is a plan view of an alternative embodiment of the present invention showing a barrel. The barrel has a plurality of spaced ridges aligned with each other over a portion of the barrel. FIG. 7 is a cross-sectional view of the barrel shown in FIG. 6 further illustrating an arm connected to the push rod. The arm includes a ridge arranged so that spaced detents on the barrel engage in stages. FIG. 6 is a plan view of an alternative embodiment of the present invention. Here, the barrel includes a peripheral ridge, and the sleeve connected to the push rod includes a ridge disposed on the inner surface of the sleeve such that the spaced ridges engage in stages. It is sectional drawing of embodiment shown in FIG. FIG. 6 is a plan view of yet another embodiment of the present invention showing a barrel having a plurality of spaced detents on its outer surface with a sleeve having a peripheral ridge for engaging the detents. It is sectional drawing of embodiment shown in FIG. FIG. 6 is a plan view of yet another embodiment of the present invention utilizing a barrel having a plurality of spaced peripheral detents in the barrel and a corresponding ridge formed in a sleeve surrounding the push rod. It is sectional drawing of embodiment shown in FIG. FIG. 6 is a perspective view of a dispensing device according to another aspect of the present invention. The device includes a syringe, a plunger rod slidably disposed therein, and a control component that interconnects the syringe and the plunger rod. FIG. 15 is a view of a dispensing device according to another aspect of the present invention, and is a cross-sectional view of the device shown in FIG. FIG. 3 is a cross-sectional view of a control component in three different positions according to aspects of the present invention. FIG. 3 is a cross-sectional view of a control component in three different positions according to aspects of the present invention. FIG. 3 is a cross-sectional view of a control component in three different positions according to aspects of the present invention. FIG. 5 shows the control components of an alternative dispensing device according to aspects of the present invention. FIG. 5 shows the control components of an alternative dispensing device according to aspects of the present invention.

  Referring to FIG. 1, a syringe 10 according to the present invention for delivering a metered multiple dose / dose is shown. The syringe includes a barrel 14 having an open end 18 and an opposing spaced port 22. The port is adapted to receive a conventional needle 26 shown in broken lines. A piston 30 is slidably disposed within the barrel 14 through the open end 18 of the barrel and a push rod 34 is connected to the piston for sliding the piston 30 within the barrel 14.

  The structure 40 that interconnects the barrel 14 and the push rod 34 allows the push rod 34 and the piston 30 to move in stages within the barrel 14.

  As described below, the structure 40 provides an acoustic indication of the gradual movement of the push rod 34 and piston 30 within the barrel 14 as indicated by line 44 in FIG. Configured to deliver multiple doses of drug without visual inspection. This is particularly useful when delivering medication using an endoscope 52 as shown in FIG.

  While an operator 48 (such as a surgeon or urologist) is chased to operate the endoscope 52 to be able to see the appropriate area of the body tissue 54, the operator is Further, the endoscope 52 must be released with one hand to control the syringe 10, position and secure the endoscope 52, and grasp and push the syringe 10.

  During this time, the endoscope 52 and the needle 10 tend to move. According to what has been found in the prior art, the momentum of the hydraulic pressure when the piston (not shown) is first pushed may cause the piston to move beyond a desired point on the barrel (see FIG. Not shown), an excessive amount of fluid would be administered at each injection site. The syringe 10 according to the present invention prevents this overrun by having “ratcheted stops” spaced at appropriate intervals to deliver the desired volume. Furthermore, since the endoscope operator 48 does not have to take off his eyes from the images relayed by the endoscope 52, the operation can be performed by one person without requiring an assistant.

  Referring now again to FIG. 1, according to the present invention, the structure 40 includes a plurality of spaced ridges 58 disposed on the outer surface 62 of the push rod 34 and an engagement disposed on the inner surface 70 of the barrel 14. Possible ridges 66. The movement of the push rod 34 in the direction indicated by the arrow 72 causes a gradual engagement between the ridges 58, 66 resulting in not only a tactile feel by the operator 48 but also a sound generation as indicated by the line 44 in FIG. . By selecting interval 76, for example, a 1 milliliter dose can be drained from a multiple milliliter syringe. Thus, the syringe 10 of the present invention allows for the administration of accurate and precise doses / divided doses of fluid in a quick and step-wise and simple manner. An enlarged view of the structure 40 showing the ridges 58, 66 in engagement is shown in FIG.

  FIG. 4 is an alternative embodiment of structure 80 according to the present invention, wherein structure 80 includes a plurality of detents 82 on push rod outer surface 86 and correspondingly disposed on barrel inner surface 92. And a ridge 88 that can be combined.

  The control of the gradual movement tactile sensation display provided by structure 96 for push rod 98 and barrel 100 is shown in FIG. 5, where detents 104 and ridges 108 correspond to corresponding ridges 82 shown in FIG. , 88, thereby changing the tactile and audible detection of the movement of the push rod 98 within the barrel 100.

  In yet another embodiment, a syringe 112 is shown in FIGS. 6 and 7 and includes a barrel 114, a piston 116, and a push rod 118. The syringe barrel 114 is stepwise engaged with a plurality of spaced ridges 122 disposed on the outer surface 126 of the barrel 114 and the ridges 122 connected to the push rod 118, as shown in FIGS. And an arm 130 including an arm ridge 132. In this syringe 112, the ridges 122 are aligned with each other around the barrel 114 or over a portion of the outer surface 126, and the width of the arm 130 is narrower than the circumference of the push rod 118.

  In yet another embodiment, syringe 134 is shown in FIGS. However, common character reference symbols indicate elements that are the same or substantially similar to those already described in connection with other embodiments of the invention.

  As shown in FIGS. 8 and 9, the syringe 134 includes a plurality of spaced peripheral ridges 138 disposed on the outer surface 140 of the barrel 142, and the sleeve surrounds and is connected to the push rod 150. A peripheral ridge 154 disposed on the inner surface of the sleeve 146 allows for stepwise engagement of the barrel ridge 138 in the same manner as described above in connection with the previously described embodiments of the present invention. .

  FIGS. 10 and 11 show yet another embodiment of a syringe 162 according to the present invention that attaches to a push rod 178 and a barrel 164 that includes a plurality of spaced detents 168 and an outer surface 170 of the barrel 164. And an arm 174 that includes a ridge 180 disposed on the arm inner surface 182 to engage the detent 168 in a stepwise manner.

  Another embodiment of a syringe 190 is shown in FIGS. The syringe includes a barrel 194 having a peripheral detent 198 spaced from the barrel surface 200 and a ridge 210 that surrounds the push rod 206 and is disposed on the inner surface 214 of the sleeve 204 such that the spaced detent 198 engages in stages. And a sleeve 204.

  The method according to the present invention utilizes any one of the syringes 10, 112, 134, 162, 190 described above, and relates to the syringe 10, placing a drug in the barrel 14, Manipulating the structure 40 interconnecting the barrel 114 and the push rod 34 to move the push rod 34 and the piston 30 in stages in the barrel 114 to administer a dose of drug.

  In another aspect, the present invention provides, among other features, (1) a dosing mechanism that allows a substance to be dispensed repeatedly, precisely and accurately, and (2) allows a user to leave the dosing mechanism. A dispensing device is provided that provides a release mechanism.

  FIG. 14 is a perspective view of an exemplary embodiment of a dispensing device 300 provided in accordance with an aspect of the present invention. Briefly, the dosing device 300 includes a syringe 310 connected to the plunger rod 320 by a control component 330. The syringe 310 can be a standard or custom syringe. It may or may not be pre-packaged with other parts of the dosing device 300. The control component 330 includes an actuator 360 that operates the dosing device 300. In one embodiment, the actuator 360 is a button. In an alternative embodiment, the actuator 360 is a lever.

  As shown in FIG. 15, the plunger rod 320 includes an engagement surface 340. In one embodiment, the engagement surface 340 comprises a rack having a plurality of spaced teeth 345. The spaced teeth 345 are evenly spaced in the longitudinal direction over at least a portion of the surface of the push rod 320. The distance between one tooth and the next tooth defines an inter-tooth spacing 365 or pitch, as shown in FIG. 16A. The interdental spacing 365 corresponds to a predetermined volume of liquid. In alternative embodiments, the engagement surface 340 includes a ridge, detent, and the like.

  In one embodiment, the control component 330 is a plunger assembly. Plunger assemblies for dispensing devices are described, for example, in US Pat. No. 3,161,323, the entire contents of which are hereby incorporated by reference.

  Referring to FIGS. 15 and 16A, the control component 330 moves the push rod 320 within the syringe 310 to repeatedly and accurately deliver a housing 350 having an upper side 355 and a predetermined volume of liquid composition disposed in the syringe. And an actuator 360 for operating the dosing device 300 so that it can be moved step by step. In one embodiment, the actuator 360 is a button. In an alternative embodiment, the actuator 360 is a lever. In one embodiment, the actuator 360 is vertically movable to various positions relative to the upper side 355. In one embodiment, the actuator 360 has three basic positions that correspond to different heights relative to the upper side 355. In the fully extended position, the actuator 360 is at its maximum height. In the fully depressed position, the actuator 360 is at its minimum height relative to the upper side 355. In the partially extended position, the actuator 360 is partially depressed and has an intermediate height between a maximum height and a minimum height. The motive force that lifts the actuator 360 up may be provided by a spring or some other mechanical design element well known to those skilled in the art.

  In one embodiment, the housing 350 houses a pawl 380 that is rotatably connected to the pivot pin 410. In one embodiment, pawl 380 has a wedge-shaped end portion 390 that reversibly engages spaced teeth 345 on engagement surface 340 in the dispensing mechanism described herein. To do. A stop pin 400 is placed adjacent to the inside of the pawl 380 to limit the pawl 380 from moving clockwise. The biasing element 370 connects the pawl 380 to the actuator 360. In one embodiment, the biasing element 370 is a spring.

  Referring to FIG. 16A, in the reset or start position, the actuator 360 is at its maximum height relative to the upper side 355. The biasing element 370 is in the extended state. End portion 390 of pawl 380 is disengaged from a plurality of spaced teeth 345 on engagement surface 340.

  In the partially actuated position shown in FIG. 16B, the actuator 360 is partially depressed so that its height relative to the upper side 355 is at an intermediate height between the maximum and minimum heights. Yes. Pushing the actuator 360 partially compresses the biasing element 370, causing the end portion 390 to engage the first tooth 345 on the engagement surface 340. The biasing element 370 ensures that the end portion 390 of the pawl 380 remains engaged with the first tooth 345.

  In the fully actuated position shown in FIG. 16C, the actuator 360 is fully depressed. When the biasing element 370 is compressed, the pawl 380 tilts backward, and the plunger rod 320 and the engagement surface 340 are pushed forward. In this position, the pawl 380 is no longer in contact with the stop pin 400. When the actuator 360 is released from this position, the end portion 390 of the pawl 380 disengages from the first tooth 345 and then aligns to engage the next tooth when the actuator is pushed. The interdental spacing between spaced teeth 345 correlates with the desired dosage. Each time the actuator 360 is actuated, the plunger rod 320 is advanced by exactly one increment corresponding to the inter-tooth spacing 365 or pitch 365. In one embodiment, 0.1 ml is dispensed per actuation. In an alternative embodiment, a volume of less than 0.1 ml is dispensed per actuation. In still other embodiments, more than 0.1 ml is dispensed per actuation.

  In one embodiment, the dispensing device provides a release mechanism that allows the user to move the plunger rod 320 for aspiration, filling, draining, or dispensing of an amount other than that determined by the interdental spacing 365. Has the option to pull freely in both directions. To use the release mechanism, the user releases actuator 360 so that it can return to its maximum height relative to upper side 355 as shown in FIG. 16A. In one embodiment, a pin (not shown) may be incorporated into the actuator 360 and maintained in this position so that the pawl 380 disengages from the engagement surface 340 of the plunger rod 320. When ready, the user may remove the pin holding the actuator 360 in the fully extended position (eg, by using a pull tab accessible from outside the device). When the pin is removed, the biasing element 370 engages the pawl 380 with the engagement surface 340. This particular embodiment can prove useful if the disengagement is only required at the beginning of the surgery. For example, if the injection device is to be pre-filled with the diluent used for reconditioning, the user needs to inject the diluent freely and freely aspirate the reconditioned product into the device. . After filling the device, the user can pull the tab and arrange the device to dispense in increments.

  Thus, an aspect of the dispensing device includes a barrel having an open end and opposed spaced ports adapted to receive a needle, and a plunger rod slidably disposed within the barrel through the barrel open end. A plunger rod having a plurality of spaced teeth over at least a portion of its upper side and having an interdental spacing between the teeth and interconnecting the barrel and the plunger rod A dosing device comprising a control component for performing the operation. In one embodiment, the control component includes a pawl having an end point configured to engage a plurality of spaced teeth and an end point to allow the plunger rod to move in stages within the barrel. In the interproximal spacing, engaging the teeth and moving the plunger rod forward by an increment corresponding to the interproximal spacing, and an actuator for actuating a stepped movement. In one embodiment, the actuator is moveable from a reset position, the end point is disengaged from a plurality of spaced teeth to a partially actuated position, the end point engages the first tooth to a fully actuated position, and the end point is Moving from the first tooth to the second tooth, the plunger rod can freely slide in the longitudinal direction of the barrel in the reset position.

  In an alternative embodiment shown in FIGS. 17A and 17B, the dispensing device 500 includes a control component 530. In one embodiment, the control component 530 includes an actuator 560, a housing 550 having an upper side 555 that houses the biasing element 570, a “double pawl” 580 that is rotatably connected to the pivot pin 510, and a pawl 580. And a stop pin 590 for restricting the movement of the lens in the clockwise direction. The double pawl 580 has a first side 581 having an end point 585 that is engageable with the engagement surface 540 of the plunger rod 520 and a second side 582 that does not contact the engagement surface 540. In one embodiment, the “double pawl” 580 typically engages a plurality of spaced teeth 545 on the engagement surface 540 of the plunger rod 520. In one embodiment, actuator 560 is movable from a rest position to an actuated position. In the resting state, as shown in FIG. 17A, the actuator 560 is positioned at a height relative to the upper side 555 so that the biasing element 570 is partially compressed and a plurality of spaced teeth at the engagement surface 540. One of the 545s and the end point 585 are kept engaged. In the activated state, the actuator is depressed to further compress the biasing element 570. When the biasing element 570 is compressed, the pawl 580 is tilted rearward and the plunger rod 520 and the engagement surface 540 are pushed forward (not shown) by a mechanism similar to that described in FIGS. 16A, 16B and 16C. .

  In one embodiment, the plunger assembly 530 is connected to a spring biased slider actuator 600. As shown in FIG. 17A, in the locked position, the spring 610 connecting the slider actuator 600 to the housing 550 is in the extended state, and the slider actuator 600 is spaced from the second side 582 of the “double pawl” 580. Yes. In this locked position, the user cannot pull the plunger rod 520, but the user can control suction without losing a point on the engagement surface 540.

  In the released state shown in FIG. 17B, in order to disengage the “double pawl” 580 from the engagement surface 540, the user pushes the slider actuator 600 forward and the second side 582 of the “double pawl” 580 Make contact. As the spring 610 is compressed, the “double pawl” 580 is tilted backward and is disengaged from the engagement surface 540. In this position, the user can pull the plunger rod 520 in both directions for aspiration, filling, draining or dispensing of an amount other than the amount determined by the inter-tooth spacing or pitch of the plurality of spaced teeth 545. it can.

  Thus, an aspect of the dispensing device includes a barrel having an open end and opposed spaced ports adapted to receive a needle, and a plunger rod slidably disposed within the barrel through the barrel open end. A plunger rod having a plurality of spaced teeth over at least a portion of its upper side and having an interdental spacing between the teeth and interconnecting the barrel and the plunger rod Control parts to be provided. In one embodiment, the control component includes a pawl having a first side having an end point engageable with a plurality of spaced teeth, and a second end opposite the first side, and the plunger rod is a barrel. Means for moving the plunger rod forward by an increment corresponding to the interdental spacing, with the end points being interdentally engaged, engaged with the teeth, in order to be able to move stepwise within And an actuator for actuating stepwise movement. In one embodiment, the actuator is movable from the rest position, the end point engages the first tooth to the actuated position, and the end point moves from the first tooth to the second tooth. In one embodiment, the control component is a compressible slider actuator facing the second side of the pawl, the slider actuator further comprising a slider actuator that is movable from a locked state to a released state, the locked state The slider actuator is spaced from the second side of the pawl, and in the released state, the slider actuator strikes the second side of the pawl at an angle and the end point of the first side is separated from the plurality of spaced teeth. Engage. In one embodiment, in the released state, the plunger rod is free to slide longitudinally through the barrel.

  In alternative embodiments, multiple engagement surfaces having different tooth sizes on different sides of the plunger rod may be used, so that different administrations are achieved by rotating, removing or replacing the plunger rod. The volume size can be dispensed with one single device. The dose variation depends on the pawl geometry but is still driven by the inter-tooth spacing or pitch of the rack (s).

  Further embodiments take into account the need for suction in some cases. This may be necessary in situations where the user wishes to confirm that he is not infusing into the blood vessel (e.g. any red signs in the syringe being aspirated will cause the needle to enter the blood vessel). Show). When the pawl is engaged, it generally sits somewhere between the rack teeth on the engagement surface. Thus, the rack can be pulled back slightly before stopping suddenly against the pawl (similar to gear backlash). This mechanism can be utilized as an advantage because it allows for consistent aspiration from injection to injection without pushing the final dose to deliver (the user cannot skip teeth on the rack).

Examples The present invention treats diseases or conditions such as urological diseases or conditions (ie, bladder dysfunction such as overactive bladder), prostate disorders, eye diseases or conditions, or any other human disease, condition or disease. Particularly useful in cystoscopes for injecting a formulation such as botulinum toxin into a target tissue such as the bladder wall.

  The normal urination process is the result of a complex network of nerve stimulation transmission of the bladder and urethral sphincter, which ensures that healthy individuals are urinated in a timely manner after sufficient bladder filling. During the urine collection period, the bladder neck and urethra remain closed and the detrusor muscles are relaxed (due to noradrenaline beta receptor stimulation at the top of the bladder) to keep urine in the bladder. In a healthy bladder, urination begins when the pressure in the bladder is greater than the pressure in the urethra. The sensation of pain and bladder fullness is carried by afferent fibers. The afferent fibers carry that information from the bladder to the pontine urination center of the brain that encourages urination. The micturition phase consists of coordinated relaxation of the bladder floor and urethral sphincter (by noradrenaline alpha receptor stimulation) and suppression of noradrenaline stimulation followed by parasympathetic stimulation via the neurotransmitter acetylcholine. Includes shrinkage.

  Overactive bladder is a condition that disrupts the normal urination process. This is a complex syndrome characterized by urgency and frequent urination, with or without urinary incontinence. Urinary incontinence results from involuntary contraction of the detrusor muscle during urination (detrusor overactivity). Urinary incontinence occurs in most cases in the absence of obvious morbidity. In such cases, abnormal detrusor contractions are called idiopathic overactive bladder. The remaining case is associated with a neurogenic morbidity and is called neurogenic detrusor overactivity.

Neurogenic detrusor overactivity The pathophysiology of OAB is complex and includes peripheral and central nervous system (CNS) dynamics. Several CNS diseases are associated with the development of OAB, including spinal cord injury and multiple sclerosis. Neurological disorders involving the spinal cord can lead to urinary incontinence with the loss of inhibitory input from the micturition center and by blockage of the spinal-bridge-spinal pathway that normally controls bladder behavior. During spinal cord injury, there is a change in the balance of afferent fiber activity between the bladder muscle and submucosa. Unmyelinated C fibers become functionally superior, and the detrusor hyperreflexia described in such patients is believed to be due to reflexes mediated by these unmyelinated C fibers.

  A demonstrable result on urination hydrodynamics is abnormal involuntary detrusor contraction, often resulting in urinary incontinence. In addition, these patients are often plagued by a loss of coordinated relaxation of the urethral sphincter, usually prior to urination. This lack of coordinated activity results in not only urinary incontinence but also vesicoureteral reflux. Bladder-ureter reflux can cause kidney damage if left untreated.

Available treatments Clean intermittent self-induction (CIC) is commonly used to urinate from the bladder, manage neurogenic incontinence, and prevent vesicoureteral reflux. When using CIC, a patient inserts a catheter through the urethra into the bladder to produce urine. However, CIC can be associated with infectious diseases. This reignites the problem of urinary incontinence and, in some situations, can cause kidney damage. Common medications that reduce bladder contractility include anticholinergics, anticonvulsants and antidepressants. However, these treatments are associated with a high incidence of side effects. Side effects of anticholinergic drugs include dry mouth, constipation and visual impairment. Currently, the only option available to patients who are unresponsive to or discontinuing anticholinergic drugs is an implantable device that stimulates the sacral nerve over time, or an invasive procedure such as surgically expanding the bladder It is. Although some procedures may be effective for some patients, they are very invasive, do not necessarily guarantee excretion suppression, and may have long-term complications.

Botox® (Type A Botulinum Toxin Purified Neurotoxin Complex) Treatment Recently, studies have been conducted using Botox® (botulinum toxin) to treat patients with overactive bladder. Attempts have been made to suppress involuntary detrusor contraction by locally administering Botox (registered trademark) (botulinum toxin) to the detrusor. It contains acetylcholine, calcitonin gene-related peptide (CGRP), glutamate, substance P, and cleaves acetylcholine by cleaving SNAP25, a protein essential for successful docking and release of vesicles in nerve endings. Inhibits release. Botox® (botulinum toxin) is thought to inhibit acetylcholine-mediated detrusor contraction, and other small molecules in both the afferent and efferent pathways of the bladder wall, urothelium or lamina propria. It can inhibit intracellular neurotransmitters.

  There is evidence of the successful use of Botox® (botulinum toxin) in the management of neurogenic incontinence. Injecting 200 U to 300 U (10 units per mL per injection site) of botulinum toxin into the detrusor over 20 to 30 injection sites restores excretion suppression and anti-cholinergic treatment for such patients Has been found to be effective in enabling reduction or discontinuation of In a study involving 21 patients, 17 out of 19 patients with follow-up data recovered excretion suppression within 6 weeks. To date, treatment of over 900 patients with neurogenic overactive bladder with Botox® (botulinum toxin) at doses ranging from 200 U to 300 U to 20 to 30 injection sites has been reported. . The benefit of treatment has been described to last for 6 to 12 months with an acceptable side effect profile.

  Endoscopy of the bladder through the urethra is cystoscopy. Cytoscopy for diagnosis is usually performed with local anesthesia. General anesthesia may be used in cystoscopic surgery.

  If the patient suffers from a urine disease or condition, the surgeon uses the cystoscope 52 (see FIG. 2) to look inside the bladder and urethra. The urethra is a tube that carries urine from the bladder out of the body. The cystoscope has a lens that allows the surgeon to focus on the inner surface of the urinary tract. Some cystoscopes use optical fibers (flexible glass fibers) that carry images from the tip of the device to the other eyepiece. The cystoscope is about as thick as a pencil and has illumination at the tip. Many cystoscopes have additional tubes to guide other surgical devices for treating urinary problems.

  There are two main types of cystoscopes: soft and rigid, and the flexibility of the cystoscope is different. Soft cystoscopy is performed using local anesthesia for both men and women. In general, lidocaine jelly (such as the brand name Instillagel) is used as an anesthetic to be injected into the urethra. Rigid cystoscopy can be performed under the same conditions, but is generally performed under general anesthesia due to probe pain, particularly in male subjects. Embodiments of the invention described herein (see, for example, the drawings) can be used to treat metered doses (divided doses) of botulinum toxin (botox) within the patient's bladder wall (detrusor) to treat bladder dysfunction. , DYSPORT, MYOBLOC, or XEOMIN) can be used to accurately and precisely inject. The present invention is not limited to use to treat bladder dysfunction or to administer botulinum toxin. This is because the present invention can be used in any therapeutic, cosmetic or research application where an accurately and precisely quantified dosage of an aqueous pharmaceutical formulation is required.

  The present invention provides formulations such as botulinum toxin in target tissues such as head and / or neck muscles to treat diseases or conditions such as chronic migraine or other human illnesses, conditions or diseases. Help to inject.

各筋肉内注射部位＝０．１ｍＬ＝５単位のボトックス（登録商標） A study was conducted using Botox® (botulinum toxin) to treat patients with chronic migraine. For example, botulinum toxin injection into the muscles of the head and neck has been found to be effective in treating chronic migraine. The recommended dilution is 200 units / 4 mL or 100 units / 2 mL and the final concentration is 5 units / 0.1 mL. The recommended dosage for treatment of chronic migraine is 155 units, using a sterile 30 gauge 0.5 inch (12.7 mm) needle as an injection of 0.1 mL (5 units) per site. Administered intramuscularly. Injections should be divided over the seven specific head / neck muscle regions specified in the table below. In the cervical region of patients with thick cervical muscles, a 1 inch (25.4 mm) needle may be required. Except for the nasal root muscle to be injected at one site (midline), all muscles are symmetrical so that half of the injection site is administered on the left side of the head and neck and half on the right side Should be injected. The recommended retreatment schedule is every 12 weeks.

Each intramuscular injection site = 0.1 mL = 5 units of Botox®

  Embodiments of the present invention described herein are designed to treat metered doses (divided doses) of botulinum toxin (Botox®) into specific head / neck muscles of a patient to treat chronic migraine. ) Etc.) can be used to accurately and precisely inject. For example, it can be measured to provide 0.1 ml (5 U) of Botox® for each intramuscular injection each time the dosing syringe is activated.

  The present invention is not limited to use for the treatment of chronic headache or to administer botulinum toxin. This is because the present invention can be used in any therapeutic, cosmetic or research application where an accurately and precisely quantified dosage of an aqueous pharmaceutical formulation is required. Accordingly, any and all modifications, variations, or equivalent arrangements that may occur to those skilled in the art are to be considered within the scope of the invention as defined in the appended claims.

  Many changes and modifications may be made by those skilled in the art without departing from the spirit and scope of the present disclosure. For example, features and aspects specifically described in one embodiment but not specifically described in another embodiment may be interchangeable unless the modifications are consistent and inoperable. Accordingly, it is to be understood that the described embodiments are described merely for purposes of illustration and that the embodiments should not be construed as limiting the present disclosure as defined in the following claims. Don't be. Thus, the following claims are not limited to the combination of elements described in the text, but all equivalent elements for performing substantially the same function in substantially the same way to obtain substantially the same result. Should be read as including. Accordingly, the claims are to be understood as encompassing what has been illustrated and described above, what is conceptually equivalent, and what incorporates the concepts of this disclosure.

Claims (1)

A medication device comprising:
A barrel having an open end and opposed spaced ports adapted to receive a needle; and a plunger rod slidably disposed within the barrel through the barrel open end, the plunger rod A plunger rod having a plurality of spaced teeth over at least a portion of its upper side and having an interdental spacing between the teeth;
A control part for interconnecting the barrel and the plunger rod, wherein the control part is opposed to the first side face having an end point engageable with the plurality of spaced teeth, and the first side face A control component comprising a pawl with a second side to
In order to allow the plunger rod to move stepwise within the barrel, the end point is placed in an interdental space and engaged with a tooth, the plunger rod being incremented corresponding to the interdental space. Means for moving the vehicle forward;
An actuator for actuating the stepwise movement, wherein the actuator is movable from a rest position, the end point engages the first tooth to the actuated position, and the end point is the first tooth. An actuator moving from the first tooth to the second tooth;
A compressible slider actuator that faces the second side of the pawl and is movable from a locked state to a released state, wherein in the locked state, the slider actuator moves away from the second side of the pawl. spaced, and in the released state, the slider actuator, an angle at the end on the second side, to the end point of the first side in a state not engaged with said plurality of spaced teeth, A dosing device comprising: a slider actuator, wherein the plunger rod is slidable in the longitudinal direction freely in the longitudinal direction in the released state.

Images