The following relates to methods and apparatus for controlling operation of a syringe.
A syringe is a well known device that is readily available and commonly used in a variety of medical applications. The syringe is typically used to inject a drug or other liquid into a patient either subcutaneously (i.e. under the skin) or intramuscularly (i.e. into the patient's muscle mass). The syringe may be pre-assembled with a predetermined quantity of content, or an administrator may be required to fill an empty syringe prior to use. It is also known that syringes can be used in other non-medical applications for administering quantities of a substance. Although the following is described in the context of medical applications, it will be appreciated that the following concerns and principles may also apply to such non-medical applications.
As part of an injection procedure, the administrator is sometimes required to choose the size (i.e. “gauge”) of the needle that is required to pierce the patient's skin in order to administer the contents of the syringe. Thinner (higher) gauges typically pierce the skin with greater ease thus causing less pain than thicker (lower) gauges. However, a thinner gauge can result in other consequential issues. Such issues include how the gauge of the needle affects the ability of the liquid to be injected or the amount of force required if the contents have a large viscosity. As shown in the chart in
The syringe can also be used to aspirate (i.e. withdraw fluids). For example, aspiration is commonly used by radiologists to withdraw fluids from glands for examination. Additionally, aspiration may be used to fill a syringe with a liquid or drug stored in a bulk container.
The above described procedures utilize some form of manual intervention. The consistency, accuracy and overall “quality” of an injection is dependent on the precision of the amount of fluid being injected or aspirated, as well as the relative control or “smoothness” of the rate of injection or aspiration. Several factors can impact an individual's effectiveness in administering a drug. A few examples of such factors include the amount of training given to the individual, the individual's experience, strength, fatigue and vision. Therefore, the variability of an injection between individuals and different injections from the same individual is naturally a concern in the medical industry.
Of late, evidence has been discussed indicating that the precision control of the rate of an injection can have many benefits such as: i) reduced muscular necrosis due to a slower rate of injection; ii) reduction in pain; iii) better absorption of the drug by the muscle mass; iv) potential for smaller doses; v) less stress being imparted on organs such as the liver; and vi) potentially higher effectiveness of the drug.
Additionally, there are drugs in development that depend on highly viscous gel like carriers to allow a slow release, thus extending the time between injections. As these carriers typically have a relatively high viscosity, they tend to require a thicker gauge needle and greater physical exertion to administer. As such, the needle gauge and force required by the individual can also be of concern.
It is therefore an object of the following to provide a method and apparatus to obviate or mitigate the above-identified disadvantages.
In one aspect, there is provided a syringe gun comprising an elongated body with an open faced barrel cradle and open faced plunger bay for holding a syringe in the body; a plunger cradle moveable within the plunger bay for operating on a plunger of the syringe; and an actuating device for moving the plunger cradle according to a control signal.
In another aspect, there is provided a system for controlling operation of a syringe comprising a controller comprising an interface and at least one input mechanism; and a syringe gun communicably connected to the controller, the syringe gun comprising an elongated body with an open faced barrel cradle and open faced plunger bay for holding a syringe in the body; a plunger cradle moveable within the plunger bay for operating on a plunger of the syringe; and an actuating device for moving the plunger cradle according to a control signal; wherein the controller generates the control signal for controlling the syringe gun.
In yet another aspect, there is provided a syringe gun comprising an elongated body with a plurality of barrels for containing one or more substances; a plurality of plunger bays for accommodating movement of a plurality of plungers operating with the plurality of barrel; a plurality of plunger cradles moveable within the plurality of plunger bays for operating on the plurality of plungers; and one or more actuating devices for moving the plurality of plunger cradles according to a control signal.
An embodiment of the invention will now be described by way of example only with reference to the appended drawings wherein:
Referring now to
The console 12 comprises a display 18 and a number of input mechanisms 20 such as functional keys as exemplified in
The syringe gun 14 loaded with a syringe 16 is shown in greater detail in
The syringe gun 14 is shown in greater detail in
Situated between the barrel cradle 40 and plunger bay 42 is an integrated slot 46 for receiving the barrel flange 36. Extending from the linear actuator 60 along the bottom of the plunger bay 42 is a drive screw 62 having an attachment member 64 that translates along the drive screw 62. A slotted plunger cradle 48 is supported and attached to the attachment member 64 such that the plunger cradle 48 moves along the drive screw 62 with the attachment member 64. The plunger cradle 48 is defined by a forked portion 54 that is configured to accommodate the stem of the plunger 30 while limiting movement of the plunger flange 38 towards the barrel 28. The plunger cradle 48 also comprises an upstanding wall 52 spaced from the forked portion 54 such that the plunger flange 38 can be securely held between the forked portion 54 and the wall and to limit axial movement of the plunger 30. In this way, the plunger 30 can only be readily pushed or pulled under the control of the linear actuator 60.
The integrated slot 46 and barrel cradle 40 are sized to be substantially similar or marginally smaller than the syringe barrel 28 and barrel flange 36 to allow the syringe 16 to be “snapped” into the syringe gun 14. To facilitate retention of the syringe barrel 28, a pair of opposing and protruding rails 70 extend along the length of the barrel cradle 40 as can best be seen in
Alternatively, the barrel cradle 40 can be designed to have a maximum breadth based on typical syringe sized, wherein one or more shims or spacers or inserts can be inserted into the barrel cradle 40 to accommodate progressively smaller syringe sizes. In this way, an adjustable barrel cradle 40 can be provided. It will be appreciated that other adjustment mechanisms could also be used such as spring loaded side walls, barrel cradle cartridges etc.
The plunger cradle 48 should be capable of firmly secure the plunger flange 38 without allowing undue distortion during operation as it transfers forces from the linear actuator 60 to the plunger 30. By providing minimal surface area contact between the forked member 50 and the inner face of the plunger flange 38, distortion of the plunger flange 38 can be better accommodate during insertion.
To provide visual affirmation of the plunger 30 and contents of the syringe barrel 28, plunger view slots 58 and barrel view slots 56 respectively are provided. The barrel view slots 56 preferably extend along a substantial portion of the length of the side walls of the barrel cradle 40 as best shown in
As can be seen in
To secure the syringe 16 in the syringe gun 14, the plunger cradle 48 should be placed in an appropriate position. If the plunger 30 is at least partially extended (i.e. for injecting contents in the barrel 28), the plunger cradle 48 should be moved away from the integrated slot 46. If the plunger 30 is fully retracted (i.e. for aspirating fluids into an empty barrel 28), the plunger cradle 48 should be adjacent the integrated slot 46. The syringe 16 may then be placed atop the syringe gun 14 with the barrel 28 atop the barrel cradle 40 with the barrel flange 36 aligned with the integrated slot 46 and the plunger 30 along the plunger bay 42. Fine adjustments of the plunger cradle 48 can then be made to align the plunger cradle 48 with the plunger flange 38. Having this alignment, the syringe 16 may then be pressed into the syringe gun 14 preferably by applying force to the barrel 28 and plunger flange 38 simultaneously. The barrel cradle 40 should flex enough for the barrel 28 to “snap” into the barrel cradle 40 while the plunger flange 38 is secured firmly in the plunger cradle 48. In the result, the syringe gun 14 and syringe 16 assembly should appear as shown in
Turning back to
To further aid the user, the LED 76 can be used in several ways to provide a visual cue based on the nature of the action. In one embodiment, the LED 76 is “on” whenever the plunger 30 is being moved, namely whenever an injection or aspiration is being performed. In another embodiment, the LED 76 may be multi-coloured such that one colour (e.g. red) is provided when the plunger 30 is injecting and another colour (e.g. green) is provided when the plunger 30 is aspirating. In yet another embodiment, the LED 76 can be configured to flash in sequence with the volume of fluid being injected or aspirated. For example, as the plunger 30 moves forward, the LED 76 is turned on until a prescribed amount of fluid is injected (e.g. 50 microlitres). As the plunger 30 continues to move forward, the LED 76 can then be either shut off(with a single colour LED) or the colour of the LED 76 changed (dual colour) to indicate that the prescribed amount has been injected. As the plunger 30 continues past the next prescribed amount (e.g. 100 microlitres), the LED 76 can be turned back on (or return to original colour).
Since the syringe 16 is securely supported in the syringe gun 14, movement of the plunger 30 is subject to the extent of movement of the linear actuator 60. To prevent jamming the plunger 30 or plunger cradle 48, the syringe gun 14 may be equipped with end-of-travel sensors 80 (see
Turning back to
Various injection profiles can be defined for various applications. For example, one injection profile can involve multiple injections of precise amounts of the same drug into the same patient (e.g. Botox® treatments). The profile would include the following steps: 1) Press start button; 2) Dwell for 5 seconds (allows operator to position needle without stressing skin or muscle); 3) Inject 0.1 ml at the rate of 0.01 ml/second; 4) Stop (wait for next start button signal); 5) Start button signal received; 6) Dwell 5 seconds; 7) Inject 0.12 ml at a rate of 0.01 ml/second; 8) Stop; and 9) Repeat cycle.
In another example, a profile can be defined for precision aspiration in radiology. Such a profile would include the following steps: 1) Press start button; 2) Dwell 2 seconds (allow operator time to steady the needle); 3) Aspirate 0.25 ml at a rate of 0.005 ml/second; and 4) Stop.
In yet another example, a profile can be defined for precision injection volume and rate with slight aspiration at end. Such a profile would include the following steps: 1) Press start button; 2) Dwell for 3 seconds; 3) Injection of 1.1 ml of drug at a slow rate of 0.005 ml/second; 4) Stop; 5) Aspirate 0.05 ml (allows withdrawal of needle from patient without spilling fluids on body); and Stop.
In general, the controller 12 operates according to user input, which is processed by the processor 80 by executing the control program 82, which may, if necessary, load a particular injection profile 90, e.g. in the program mode. It will be appreciated that the components shown in
Operation of the syringe gun 14 using the controller 12 may be exemplified by referring to
The controller 12 then steps through a series of checks to determine the selected mode of operation according to the selected mode control setting. If the mode control setting 22 is “Off” then the controller 12 idles until another setting is chosen. If the mode control setting 22 is “Speed” then the controller 12 proceeds to the routine shown in
Turning now to
The controller 12 may then begin the injection or aspiration process by first setting a direction of travel and then sending control signals to the linear actuator 60 to operate at the selected speed. The controller 12 continually checks that the stop button 74 has not been pressed and determines if the actual volume that has been dispensed or acquired is less than the target volume for the operation. The target volume may be set automatically according to the syringe 16 that has been loaded or can be entered by the user. Preferably, the controller 12 reads the target volume from an identifier such as a barcode or RFID tag. If the stop button 74 has not been pressed and the target volume has not been reached, then the plunger 30 continues to be pressed or pulled until either the stop button 74 is pressed or the target volume is met. If the stop button 74 has been pressed, this may indicate that the user wishes to pause, rest or otherwise cease the injection or aspiration. The controller 12 will then idle until the start button 72 is pressed, at which time it will determine if the remainder of the injection or aspiration needs to be performed. Once the target volume has been met, the controller 12 may then annunciate a completed operation to the user, either visually using display 18 or LED 76 or audibly using the speaker 21.
Control then returns to A shown in
Before the controller 12 can operate the syringe gun 14, the user should be in a ready position and select the start button 72. If the start button 72 has not been pressed, this indicates that the user is not prepared to begin and the controller 12 idles until it is determined that the user has pressed the start button 72.
The controller 12 may then begin the injection or aspiration process by first setting the direction of travel as read from the profile 90 and then sending control signals to the linear actuator 60 to operate at the speed indicated in the profile 90. The controller 12 continually checks that the stop button 74 has not been pressed and determines if the actual volume that has been dispensed or acquired is less than the target volume for the operation. If the stop button 74 has not been pressed and the target volume has not been reached, then the plunger 30 continues to be pressed or pulled until either the stop button 74 is pressed or the target volume is met. If the stop button 74 has been pressed, this may indicate that the user wishes to pause, rest or otherwise cease the injection or aspiration. The controller 12 will then idle until the start button 72 is pressed, at which time it will determine if the remainder of the injection or aspiration needs to be performed. Once the target volume has been met, the controller 12 may then annunciate a completed operation to the user.
Control then returns to A shown in
It will be appreciated that other, more complex profiles 90 can be used. For example, different volume rates can be specified during corresponding stages in the operation. The controller 12 would then reference a timer in order to trigger a change in volume rate. Another example may involve a combination of both injection and aspiration stages where a first phase injects fluid at a certain rate then commences a second phase where a short aspiration is performed allowing the needle to be removed from the skin without dripping fluid on the patient.
In another embodiment, a multi-barrel syringe gun 100 is provided as shown in
It will be appreciated that such operation would involve a profile that includes multiple stages that individually controls as many plungers as required for the particular step in the profile 90. For example, if two barrels (e.g. 102 and 104) are being simultaneously injected to mix the contents in the needle port 118, the linear actuators would be programmed to move the plunger cradles 112, 114 at specific rates and for specific amounts of time such that a specific quantity for each barrel enters the needle port 118 area for mixing. It will be appreciated that the actual rates, volumes and any delay times are entirely dependent on the profile 90, which is entirely dependent on the injection or aspiration sequence.
In yet another embodiment, the speaker 21 may be used as a buzzer having numerous modes that can signal an operation's status to the user. In one example, the buzzer may “chirp” 19 whenever a certain volume of fluid has been injected or aspirated. This could be used in both speed and program modes. In the program mode, the buzzer may be programmed to sound for an extended period (e.g. 1.5 seconds) to indicate a pre-programmed task has been completed. The buzzer may be used instead of or in conjunction with the LED 76 to provide numerous visual cues for the user to assist in the process.
Although the above has been described with reference to certain specific embodiments, various modifications thereof will be apparent to those skilled in the art without departing from the spirit and scope of the invention as outlined in the claims appended hereto.
This application claims priority from U.S. provisional application No. 60/911,589 filed on Apr. 13, 2007, the contents of which are incorporated herein by reference.
Number | Date | Country | |
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60911589 | Apr 2007 | US |