DRIVE MOTOR TRANSMISSION SYSTEM
FIELD OF THE INVENTION The invention is directed to a drive motor system which operates over a wide range of speeds and torques through a novel arrangement of gears and clutches coupled with a motor which can be driven bi-directionally. In a particular embodiment, the invention is directed to fluid pumping with a mechanism that utilizes a reversible motor to achieve a range of fluid movement rates and torques. The invention is further directed to a fluid pumping mechanism with multiple inlet input lines and a mechanism to selectively open input tubing valves in any sequence to deliver said fluid to a single fluid output line. The drive motor system, valves and valve actuation systems described by the present invention may be particularly adapted for use with an intravenous infusion pump.
BACKGROUND OF THE INVENTION Motors are used to provide motive forces for applications beyond count. In many of these applications a single device is tasked with both rapid, low precision movement during a first activity and slow, precisely controlled movement during a second activity. In order to achieve both types of movement, many devices must use two motors, one for the fast movement and another for the slow movement, thus increasing cost, and the size and weight of the device. Other options include the use of stepper motors, which are able to develop significant slow motor speed torque and precise rotational control. However, stepped motors have numerous disadvantages, including high cost, the need for relatively complicated control circuitry, large size and weight, and high power requirements, which make stepper
motors unsuitable for long duration battery operation. Thus, a need exists for a system which can provide both rapid, low precision movement and slow, high precision movement using an inexpensive, lightweight motor with low power requirements. The disadvantages of presently available motor systems are exemplified by medical infusion pump systems. Intravenous infusion therapy is prescribed where it is desirable to administer medications and other fluids directly into the circulatory system of a patient. Medical infusion pumps have typically employed stepper motors to provide rotational motive force, and thus are limited by the disadvantages of a stepper motor as listed above. Thus, a need exists for an infusion pump which employs a small, lightweight fluid driving mechamsm to make the pump appropriate for uses requiring portability and long duration battery operation, while still able to deliver the wide range of fluid movement speeds and torques required for a variety of applications. With particular reference to infusion pumps, for many clinical procedures it is desirable to administer several fluids to a patient simultaneously, thus requiring multiple independent gravity flow controllers or multiple independent electronic pumps. The use of multiple independent controllers or pumps however is disadvantageous for many reasons, including: the increased possibility of infection occasioned by multiple IV venipuncture; the increased discomfort to the patient, the considerable labor and time required for administering multiple IVs and setting up multiple controllers/pumps; the increased clutter around the patient; the comparatively high cost of procuring and maintaining several pumps; and the comparatively high cost incurred in maintaining an inventory of tubes required by each of the different pump types.
Past attempts to overcome these difficulties have resulted in devices with multiple fluid line valves such as that described in U.S. Patent No. 4,696,671. The disclosed device utilizes a sterile, disposable cassette containing fluid input and output lines and chambers. The cassette is inserted into a pumping mechanism such that plungers from the pump mechanism engage and close the valves of the cassette; thus, the valves of the cassette are biased to an open state when not engaged by the pump mechamsm. This arrangement has often resulted in unintentional fluid flow to the patient when the valve set was mistakenly removed from or incorrectly aligned within the pump unit. The device of U.S. Patent No. 4,696,671 has the further disadvantage that during operation the valves must be opened sequentially in order to reach the valve of interest, therefore an additional valve and independent motive force for the valve is require to prohibit flow during the period in which the unintended valve is open. That is, a third motor is required compared to just two motors in the present invention. In some circumstances, this sort of "pulsation" of the valves is not desirable due to fluid interactions or fluid damage such as cell damage as occurs with blood. Thus, a need exists for an inexpensive infusion pump capable of simultaneously infusing multiple fluids, capable of opening each valve independently of or in combination with the other valves in the system, and having valve mechanisms which are biased to a closed state.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a drive motor system that includes a bi-directional motor having a first gear and a one-way clutch where the first gear is in mechanical contact with a second gear which is in turn in mechanical contact with an
output shaft such that when the motor is turned in one direction a first output is produced. Also provided in such a system is a third gear with a one-way clutch that is in mechanical contact with the first gear and with a plurality of additional gears which are in mechanical contact with the output shaft such that when the motor is turned in the second direction a second output is produced. A further object of the invention is a method of providing a device with a wide range of motor speeds and torques by providing a drive motor system that includes a bi-directional motor having a first gear and a one-way clutch where the first gear is in mechanical contact with a second gear which is in turn in mechanical contact with an output shaft such that when the motor is turned in one direction a first output is produced. Also provided in such a system is a third gear with a one-way clutch that is in mechanical contact with the first gear and with a plurality of additional gears which are in mechanical contact with the output shaft such that when the motor is turned in the second direction a second output is produced. A further object of the invention is a fluid pump and method of pumping fluids using a pumping means including a drive motor system and drive method described in the preceding paragraphs. Such a fluid pump may employ additional elements of the present invention including a rotary or linear pump head, a plurality of fluid input lines in fluid connection with a manifold which is also in fluid connection with a fluid output line, a plurality of pinch valves which engage the fluid input lines, a valve actuation system, a pressure measurement system, a power supply, a computer processor and control system, and a housing adapted to receive such elements. It is a further object of the invention to provide an improved pinch valve, where the improvements include a plurality of ribs designed to form a piece of tubing into a serpentine shape, and adaptations which allow the pinch valve to receive or be
received by a valve actuation system. Such an adaptation may include a plurality of slots or pins. It is a further object of the invention to provide an actuation system and method for opening and closing the pinch valves. Such a system includes a bi- directional drive motor, a central drive gear in mechanical contact with the output shaft of the motor, a plurality of mutilated gears in mechanical contact with the central drive gear, and a plurality of actuator cams in mechanical contact with the mutilated gears, where the actuator cams are adapted to receive or be received by the pinch valves, such that rotation of the cam causes the pinch valve to open or close.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
For the purposes of the present invention, the following terms shall have the following meanings: For the purposes of the present invention, "a" or "an" entity refers to one or more of that entity; for example, "a valve actuation cam" or "an pinch valve" refers to one or more of the components or at least one component. As such, the terms "a" or "an", "one or more" and "at least one" can be used interchangeably herein. It is also noted that the terms "comprising," "including," and "having" can be used interchangeably. Furthermore, a component "selected from the group consisting of refers to one or more of the components in the list that follows, including mixtures (i.e. combinations) of two or more of the components. As used herein, a "pump" refers broadly to means for moving fluid. A pump may operate through changes in pressure and/or gravity. Pumps include but are not
limited to rotary peristaltic pumps, linear peristaltic pumps, centrifugal pumps, diaphragm pumps and piston pumps. As used herein, a "fluid" refers to any matter having fluidic properties, including but not limited to liquids, suspensions, gases and mixtures thereof. As used herein, a "gear" is intended to broadly refer to any structure commonly used to transfer or receive a motion. Gears of the present invention may include, for example, toothed or cogged structures, chains, pulleys, friction devices and combinations thereof. To overcome the disadvantages of previous systems which attempt to provide both high speed and lower speed movement, the present invention describes a system of gears and clutches used in combination with a bi-directional motor to form a simple transmission. In a particular embodiment, a motor drive system of the present invention includes a bi-directional motor having a motor shaft and a motor gear attached to the motor shaft, a first gear having a one-way clutch, where the first gear is in mechanical contact with the motor gear and also with a second gear, where said second gear is in mechanical contact with an output shaft of a device. In operation, turning the motor in a first direction turns said first and second gears to produce an output via the output shaft but turning the motor in a second direction causes the first clutch to slip so no output is produced via the first and second gears. Also provided is a third gear having a one-way clutch that is in mechanical contact with the first gear and with a plurality of gears which are in mechanical contact with an output shaft of a device. In operation, turning the motor in the first direction produces no output via the third gear, but turning the motor in the second direction turns the third gear and the plurality of gears to produce a second output.
The present invention also includes a method of providing a device with a range of motor speeds and torques. In a particular embodiment this method includes providing a bi-directional motor having a motor shaft and a motor gear attached to the motor shaft, a first gear having a one-way clutch, where the first gear is in mechanical contact with the motor gear and also with a second gear, where said second gear is in mechanical contact with an output shaft of a device. In operation the method includes turning the motor in a first direction, which turns said first and second gears to produce an output via the output shaft, and turning the motor in a second direction causes the first clutch to slip so no output is produced. The method further includes providing a third gear having a one-way clutch that is in mechanical contact with the first gear and with a plurality of gears which are in mechanical contact with an output shaft of a device. In operation, turning the motor in the first direction produces no output, but turning the motor in the second direction turns the third gear and the plurality of gears to produce a second output. Without being limited by theory, and to exemplify the concept only, the present application describes the use of such a system as the motive force in a medical infusion pump. One of skill in the art would readily understand that the system exemplified by the infusion pump could be readily utilized as the motive force in any number of devices, particularly in devices which require a wide range of speeds and torques, including but not limited to medical and non-medical compounding pumps, robotics, electronics and computers, linear and rotary actuators, automated laboratory instruments, spacecraft actuators, aircraft actuators, machine tools such as lathes, milling machines and presses, bicycle drive systems, automotive drive systems, cable drive systems, valve closure devices, centrifuges, high speed devices, fans, and energy storage devices.
In order to overcome the disadvantages incumbent in the use of stepper motors, the present invention describes a novel infusion pump mechanism in which a relatively inexpensive and lightweight motor is driven bi-directionally to achieve a dual speed and torque range system suitable for operating a fluid pump at both low and high flow rates. This system permits the design of a small and lightweight pump capable of operating long term on batteries over a wide flow range, which was not previously achievable. In general terms, a pump system of the present invention includes a housing, a pump drive motor which may be driven bi-directionally, a transmission system of the present invention, tubing through which a fluid is pumped, a rotary peristaltic pump head, a processor for controlling the pump and a power source. Additional features of a pump system of the present invention include valves which may be opened and closed to allow or impede fluid flow, a valve actuation motor and valve actuators which open and close the valves. The present invention also includes a method of pumping fluids. In a particular embodiment, such a method includes providing a fluid pumping means having an electric motor drive system described herein and operating such a system to pump a fluid. In another particular embodiment, energy required to operate the drive system of the present invention may be provided by various means, including but not limited to electricity, steam, hydropower, wind power, solar power, human or animal power and any other means known to produce energy. The pump head consists of a rotary peristaltic pump mechanism as is widely known in the field. Briefly, in a particular embodiment, the pump head has spring- loaded pinch rollers equally spaced around the pump head that rotate about roller
shafts on a sleeve bearing and pinch the flexible pump tubing against an anvil surface. The pinch rollers are designed to fully occlude the tubing against the anvil and therefore the rollers must have the ability to account for system tolerances of different tubing sets. The pinch rollers are biased away from the center of head rotation by a coil torsion spring which also retains the pinch roller on its shaft. The pinch rollers are allowed to slide an amount slightly more than the system tolerances toward and away from the tubing pinch. The motive force is a novel coil spring that engages the roller shafts on either side of the roller in a partial hole provided in the shafts. The springs therefore maintain the placement of the rollers and provide motive force. The pump head rotates and pinches the tubing against an anvil. In a particular embodiment, the anvil is movable to allow initial placement of the disposable tubing in the channel provided. In a particular embodiment, the anvil is also mechanically coupled to the motion of a pump cover. Briefly, to access the tubing channels to put a tubing set into the pump, a pump cover is provided that rotates approximately 100 degrees about two hinge points. When the pump cover is opened, the anvil is drawn away from the pinch rollers to allow placement of the tubing set, when the pump cover is closed, the anvil is moved towards the pinch rollers and the tubing is pinched there between. In one embodiment of the present invention, rotation of the rollers in a first direction moves fluid from one or more input lines to a single output line. In an alternate embodiment, rotation of the rollers in a second direction moves fluid from the output line to one or more input lines. Use of the invention in the alternate manner would allow for distribution of a fluid into multiple receptacles, for example. In a particular embodiment, the coupling of the motion of the pump cover to the motion of the anvil is accomplished as follows. The pump cover is pivotally
connected to the housing by one or more hinges. The cover contains a partial internal gear ring adjacent to the hinge point which is arranged to mechanically connect to a gear on the anvil shaft. The gear of the anvil shaft is chosen to have a pitch diameter smaller than the ring gear of the cover. The ratio of the ring gear to the anvil shaft gear is chosen to provide approximately 200 degrees of anvil shaft rotation for approximately 100 degrees of pump cover rotation. The anvil shaft is constrained to rotate by a sleeve bearing and the anvil is mechanically engaged to the crank end of the anvil shaft by the bearing. This sleeve bearing is arranged to contact the anvil such that the rotary motion of the anvil shaft produces the linear motion of the anvil. The anvil shaft may also be arranged to rotate approximately 20 degrees past maximum displacement to provide a method of self-holding the anvil and pump cover in the open position. In a particular embodiment, a cantilever force beam cell is mechanically attached to the anvil such that as the anvil slides towards the pump head, the end of the force beam cell contacts the tubing at a point downstream from the pump head. This contact compresses the tubing at the point of contact. Pressure inside the tube causes the force beam to register more or less force in a substantially linear fashion. The pressure information may be collected continuously as the pump runs and sent to a computer processor which can use the pressure information to determine whether the unit is operating correctly. For example, the processor can determine whether a fluid reservoir is empty or whether a line is blocked by comparing current pressure to a known pressure profile. The motion of the rotary peristaltic pump head is provided by a drive motor driven bi-directionally coupled with a system of gears and clutches to produce a simple transmission. In a particular embodiment, the drive motor is a miniature DC
iron-less core motor with an integral gear train and a motor gear Gl frictionally attached to the output shaft of the motor. A gear G2 is integral to or rigidly attached to a pinion shaft and is in mechanical contact with the drive motor gear Gl with the motor held such that Gl engages G2 by the housing and threaded fasteners. Gear G2 is also frictionally attached to the clutch of G2, referred to as clutch C2 and to a worm gear integral to or rigidly attached to the pump head shaft. The rotary pump head is rigidly attached to a pump head shaft which is supported by two ball bearing assemblies retained by the pump housing and a gear plate. Between the two bearings is the driven half of the worm gear. In a particular embodiment, a mating complementary worm gear is provided which is held to mechanically connect with the driven worm gear by the worm gear shaft. This shaft is supported by common ball bearings on either side of the worm gear to produce a rigid interface of the gears to keep the gear lash minimal which insures the pump head does not have loose motion. In high range operation of a particular embodiment, as the drive motor is directed to turn clockwise (CW), gear G2 will be turned counterclockwise (CCW). Clutch C2 operates in such a fashion that turning the gear G2 in the CCW direction will engage the clutch and turn the worm gear, thus turning the pump head shaft to turn the rotary peristaltic pump head CCW, i.e. the direction of pumping fluid. The gear ratio of the motor and of Gl to G2 along with the ratio of the worm gear act to operate the pump head in the high range of fluid handling. In a particular embodiment, motor and gears are chosen to provide a high range speed and torque to deliver fluid at a rate of between 10 to 1000 mL per hour. The low speed range is achieved by rotating the pump drive motor in the opposite or CCW direction. In a particular embodiment, when gear Gl is turned in the CCW direction, G2 turns CW and clutch C2 slips on the worm gear shaft. A gear
G3 that also has a one direction clutch C3 is arranged to engage the pinion shaft such that when gear G2 turns CCW gear G3 turns CW. The pinion shaft has an integral gear G4 and is supported by common bearing assemblies. A gear combination G5/G6 is provided and axially held by an independent shaft. Gear G6 is engaged by gear G4 to turn the gear set G5/G6 CCW, thus increasing torque and reducing speed by the ratio of G4/G6. A gear combination G7/G8 is provided and axially held by an independent shaft. Gear G8 is engaged by gear G5 to turn gear set G7/G8 CW, thus increasing torque and reducing speed by the ratio of G5/G8. Gear G7 engages gear G9 which rotates on the worm gear shaft by means of a one-way clutch C9, thus the torque is increased and the pump speed is reduced by the ratio of G7/G9. Clutch C9 is arranged to engage the worm gear shaft when gear G9 is turned in the CCW direction to therefore turn the worm gear CCW, thus turning the pump head shaft to turn the rotary peristaltic pump head CCW, the direction of pumping fluid. In a particular embodiment, motor and gears are chosen to provide a low range speed and torque to deliver fluid at a rate of between 0.1 to 10 mL per hour. When the worm gear shaft is turned CCW by the motor turning CW during high range operation, clutch C9 prevents gears G4 through G9 from also being driven CCW. Clutch C9 therefore acts to significantly reduce the motor load and system noise by not having to rotate this additional mass. One of skill in the art would readily understand that fewer or greater gear combinations and gear ratios as exemplified herein may be employed to achieve the speed and torque required for the low range required for any given application of the pump. In a particular embodiment, gear combinations may be formed of a molded material such as Delrin® or similar material which provides its own bearing surface on a shaft, however, one of
skill in the art would appreciate that different materials could be employed to achieve the same result. Various methods known to those of skill in the art may be used to measure and control the motion of the pump head. In a particular embodiment, the driven half of the worm gear has four magnets equally positioned around the gear surface. A flex circuit, or other means of connecting the electrical switches to the device controller is provided. For example, a flex circuit containing two reed switches approximately 45 degrees rotationally apart may be placed on the pump housing or other suitable location adjacent to the magnets to provide a signal for approximately 12Vι degrees of the pump head. As the four magnets rotate over the reed switches a signal is generated which can be sent to the processor. Using this signal, the speed and direction of rotation can be determined based upon the sequence of switch closure, allowing the processor to insure the system is operating as requested. Valves and a valve actuation mechanism are provided as follows. Initially, it is noted that many previously described systems provide valve mechanisms which are formed as part of the infusion pump; however, such arrangements are disadvantageous because, once the tubing is removed from the pump, accidental fluid movement to the patient can occur. Therefore, it is advantageous to provide a valve arrangement which cooperates with the mode of operation of the infusion pump, but which can also be manually opened and closed apart from the operation of the infusion pump. In a particular embodiment, such a valve arrangement is designed to automatically close when the valve is removed from the infusion pump. A particular embodiment of the present invention described below includes a plurality of tubing pinch valves which are designed to be biased to the closed position.
Briefly, the pinch valves operate in a manner similar to a sprung clothespin in that they comprise two elongated members which are coupled by and/or biased by a spring or other biasing force at a pivot point such that the elongated members are forced together at one end and apart at the other. The valves are further adapted such that a fluid input line of a tubing set described below can run between the elongated members and thus be pinched by the ends which are normally together, i.e. the valve is closed and fluid will not flow through the tubing. When force is applied to compress the ends (which are normally apart) towards each other, the ends which are normally together will be forced apart, therefore releasing the pinched tubing, i.e. the valve is opened and fluid is free to flow through the tubing. In a particular embodiment, the elongated members of the valve have ribs or ridges on the surfaces that contact the flexible tubing such that the tubing is formed into a serpentine path when the valve is in the closed position. In a particular embodiment, the first elongated member has two ribbed valleys perpendicular to the flow path of the flexible tubing that are spaced on the member surface to receive two ribbed peaks found on the surface of the other elongated member when the ribbed surfaces are biased together. When the valve is in the closed position, the ribs compress the flexible tubing into a serpentine path, thus forming three contact points where the inside walls of the tubing will be forced to meet, i.e. the tubing will be compressed together at three closure points and fluid will not be able to flow. When the valve is in the open position, the ribs are spaced a sufficient distance from each other to allow the tubing to return to a substantially straight path, and thus permit full fluid flow. In a particular embodiment, a plurality of guide members integral to the elongated members are provided for insuring that the flexible tubing is retained in the
proper place, and that the tubing will be oriented correctly to be formed into a serpentine path. The elongated members, guides, ridges and biasing means may be formed of any material which will provide the required strength and flexibility, such as plastic. A system and method for opening and closing the pinch valves is provided as follows. In a particular embodiment, the elongated members of the valve are engaged by a valve actuator cam at the ends which are normally biased away from each other, such that the action of the cam forces theses ends towards each other to open the valve. The valve cam actuator is held in place by a sleeve bearing in which it is axially retained by a torsion spring connection through the center of the cam shaft. The torsion spring provides rotational motive force to the cam and axially retains the cam by the inside edge of the spring wire passing through a central hole in the shaft of the cam. The geometry of the wire form and the preload of the spring prevent it from disengaging from the hole. An actuator gear engages the actuator cam shaft by use of a suitably sized rotational clutch. This clutch is frictionally fit to the inside diameter of the cam actuator gear such that the clutch is arranged to engage the cam shaft when the cam actuator gear is being turned in the direction required to open the valve. When the cam actuator gear is turned in the opposite direction the clutch slips on the shaft causing no motion in the valve actuator cam or valve. In a particular embodiment, a method for valve actuation is accomplished as follows. The valve actuation cam is provided with slots adapted to receive pins which protrude from the elongated members of the pinch valve or are in mechanical contact with the elongated members. As used herein, "slots" and "pins" are used to broadly define openings and protrusions which complement and receive each other and are not intended to limit these components to any particular shape or size. The actuation cam
slots are arranged to have a decreasing radius rotationally around the cam so that as the cam is rotated the decreasing radius of the cam engages the pins and forces the elongated members of the valve, which are normally bias away from each other, to approach each other, thereby opening the valve. In another particular embodiment, the pins are on the upper surface of the actuation cam and the valve surface has slots adapted to receive the pins such that rotation of the cam will cause the valve to open. Each valve actuator gear is in intermittent geared contact with a mutilated gear that pivots about a shaft on a sleeve bearing. Each mutilated gear has two or more vertical sections of teeth. A system utilizing two sections, referred to as "upper" and "lower" sections is described to exemplify the invention only. In a particular example, the edge of the upper section has teeth around the full circumference and the edge of the lower section has teeth on less than the full circumference of the gear. The amount of the edge of the lower section having teeth is determined by the number of valves to be controlled. For example a two-valve system would have gear teeth on approximately one-half of the circumference of the lower edge while in a system having four valves the lower section of the mutilated gear would have gear teeth on approximately one-quarter of the circumference, i.e. about 90 degrees of rotation. The cam actuator gear is arranged to make and break contact with the mutilated lower section of the mutilated gear, thus providing a system where each cam actuator gear is in geared contact for approximately 90 degrees of rotation of its corresponding mutilated gear, in a four-valve system. In a particular embodiment, the mutilated gears are arranged in an arc such that the upper section of each mutilated gear is in geared contact with a central drive gear. This arrangement provides a central location where a central gear can drive all four mutilated gears simultaneously and
where only one cam actuator gear is in geared contact with the central drive gear at any given time. Alternately, multiple valves may be opened at the same time. For example, a mutilated gear with 180 degrees of coverage may be used in a four-valve system. The 180 degrees of coverage may be contiguous, thus opening two neighboring valves or may consist of two 90 degree sections opposing each other such that every other valve may be opened simultaneously. Likewise, a gear with full coverage could be used in a four-valve system to open all four valves simultaneously. One of skill in the art would understand that various mutilated gear arrangements could be employed in the present system to open and close different valves independently, simultaneously and in numerous combinations. In a particular embodiment, the central drive gear contains four magnets that are arranged to rotate above two reed switches approximately 45 degrees rotationally apart. As the four magnets rotate over the two reed switches a signal is generated which can be sent to the processor. Using this signal, both rotation and direction of rotation can be determined based upon the sequence of switch closure, allowing the processor to insure the actuator is operating as requested. The central drive gear is in geared contact with the actuator motor either directly or through one or more transfer gears. In a particular embodiment, the actuator motor is a standard brushed DC motor with an integral gear reduction that can be driven bi-directionally. This motor is sized to deliver appropriate speed and torque to the actuator cam to motivate the opening of the valve. In operation of a particular embodiment, as the actuator motor rotates CW, the central gear turns all four mutilated gears simultaneously and due to the rotational offset arrangement of the mutilated gears, a single actuator gear will be
in geared contact and rotating in a direction of slip for the clutch. As the actuator motor rotates CCW, the actuator gear in geared contact will be required to rotate in a direction that causes the clutch of the actuator gear to engage and thereby rotate the actuator cam approximately 90 degrees. As the actuator motor rotates in the CCW direction, the actuator provides the motive force to rotate the cam in order to open the valve. The torsion spring of the actuator provides the motive force to rotate the cam to the initial position, when the motive force of the motor is removed, thereby closing the valve. The actuator motor can be rapidly placed in random contact with each actuator cam gear for opening that valve, thus providing a means for opening a single valve at a time without disturbing the fluid valves that are not meant to be opened. In operation of a particular embodiment, the elongated members of the valve and/or the cam walls have a slight taper. In the initial rest position the valves are closed and fit loosely in recesses provided. With the pump cover in place the valves will be held in the recesses provided and will be forced to open by the action of the valve actuators. However, if the pump cover is opened while the valve actuator is acting on a valve, the restraining force is removed and the taper of valve and/or cam walls lifts the valve out of the recess and the valve spring causes the valve to return to a closed and safe position. The valve cam is also rotationally biased by the torsion spring to the closed position; therefore if the motive force is lost due to power loss the valve again returns to the closed and safe position. Sensors may be used to verify valve motion. In a particular embodiment, electrical switches or wire forms such as torsion springs are placed such that a portion of the switch protrudes into the valve housing area. In the absence of a valve, the switch is closed. In the presence of a valve mechamsm the switch is opened. As the valve is opened by the actuator, this switch again closes and provides a means for the
device control unit to determine the number of valves being operated, and the position of each valve at any given time during operation. In a particular embodiment, the system includes a disposable tubing set which includes the valves described herein. When multiple fluid input lines are provided, each fluid input line is in fluid connection with a common manifold which in turn is in fluid connection with a fluid output line which interfaces with the pump head. The tubing segments and manifold described herein may be molded or formed as a single, contiguous piece or may be separate pieces in fluid connection with each other. In a particular embodiment the tubing is made of medical grade silicone tubing which may either be extruded and cut to length or injection molded to final shape and the manifold is injection molded of the same silicon as part of the tube molding process or injection molded as a separate piece of medical grade plastic. In operation of a particular embodiment, the tubing set, valves and manifold are placed in corresponding recesses provided in the pump housing, the valves are placed in valve recesses and the pump tubing is placed to interface with the rotary peristaltic pump head. Once in the proper recesses, the elements of the tubing set are further held in place by closing the pump cover. One or more separate means may be provided to assist in maintaining the tube set in its proper position in the housing. It is desirable to hold the tubing valves in the open position during product storage to prevent the flexible tubing from being permanently deformed or collapsed by the pressure of the valve during storage or due to elevated temperature. In a particular embodiment the product packaging is arranged of semi-rigid vacuum formed plastic with appropriate structures to hold the valve in the open position during sterilization or storage.
In a particular embodiment, the pump mechanism system can sense pump head motion of approximately 1/10 the minimum flow rate by the reed switches described earlier. However to actually control this amount of rotation requires the ability to control the motor armature. The pump head diameter, the tubing inside diameter, the motor gear ratio, the worm gear ratio, and the clockwise and counter- clock wise gear ratios must be matched in a fashion that the speed ratios of the transmission must overlap and provide sufficient torque multiplication for the motor at both speed ranges, yet not overrun the motor armature speed. This invention has by unique means solved this problem in a small low cost mechanism. The pump mechanism can be controlled by many types of microprocessors commonly used for control applications. As commonly understood the processor will accept the command inputs of the keys, display the status on a display, monitor the sensors for fault conditions, monitor the voltages of batteries, and direct the actuator motor and the pump motor for correct operation. One of skill in the art would readily understand that a pump of the present invention may also have additional features useful for medical applications. For example, the pump may have adaptations so that the pump may be operated on either battery power or on standard electrical outlets. The pump may have various clips or features for holding items commonly found in settings where medical treatments are administered, such as clips suitable for attaching standard syringes. The pump may also have features for mounting or hanging the pump on a pole, which may be integral to the pump or removable in nature. An example of such a pole mount is one which magnetically attaches the pump mechanism to the pole with sufficient force to allow an operator to actuate the keys, but will disengage from the pole should the patient be moved away from the mounting pole without first removing the pump from the pole.
One of skill in the art would also readily understand that the drive motor transmission system of the present invention has many applications other than the infusion pump used herein to exemplify the system. For example, the system could be used in a fluid sampling device, i.e., a device used in a fashion opposite to the described infusion pump in which a single inlet tube accepts a fluid and places fluid samples in multiple containers. A further example is the use of the system in a medical or non medical compounding pump. In this application, the multi-fluid capability described in the infusion pump above would be used to compound two or more fluids. Medical compounding pumps typically combine two or more fluids to be admimstered to a patient; however, these systems are not connected to the patient and are not used for administration purposes. Non-medical compounding applications include systems for mixing two-part adhesives, foams and other fluid materials that need to be combined at the point-of-use. The present invention may be used to continuously deliver two or more compounding fluids, with precise concentrations. A further example includes the use of the present system in mechanical actuators such as those used in aircraft, spacecraft, robotics, or assembly equipment. In order to move a large mass with precision and speed, the transmission of the present invention may be used. Rotation of the motor in a first direction creates high speed to actuate the majority of the motion rapidly, and rotation of the motor in the opposite direction leads to slower more precise motion. In an assembly line, for example, an automated arm may quickly rotate to retrieve a part from storage and bring it to the point of assembly. There, the transmission motor may be rotated in the opposite direction to allow for precise positioning of the part on the item being assembled.
Another embodiment for the transmission system of the present invention is a simple, low cost drive mechanism. A motor is combined with the two-speed transmission of the present invention to provide initial motion via the lowest gear ratio and the most mechanical advantage in a first motor direction, allowing an object to start moving from a complete stop. Switching the motor direction allows for faster, sustained motion via a gain in rotational speed created by a lesser mechanical advantage (i.e., higher gear ratio). Exemplary uses of such a two-speed drive mechamsm include providing motive force for toys, scooters, cars, aircraft, boats, centrifuges, computer hard drives, CD-ROM drives and the like. In another embodiment present invention may be used in a human-powered transmission system, such as a bicycle transmission. In such a system, pedaling in one direction engages the lowest gear ratio in order to allow the cyclist to easily begin moving from a complete stop. Pedaling in the opposite direction engages the higher gear ratio in order to maintain or increase speed. Additionally, a geared interface, and a mechanism for engaging and disengaging the geared interface, may be used with the two-speed bicycle transmission system to allow the cyclist to pedal continuously in one direction, while still being able to alternate between the high and low gear ratio.
EXAMPLES The following examples are included to demonstrate particular embodiments of the invention. It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventor to function well in the practice of the invention, and thus can be considered to constitute particular modes for its practice. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.
Example 1: Use of the present invention in an infusion pump Set-up of the System A tubing set is inserted into the infusion pump system by rotating the pump cover approximately 120 degrees. The manual rotation of the pump cover causes the anvils to move away from the pinch rollers. The inlet tubes are then inserted in the space between the anvil and the pinch roller and pinch valves on each of the inlet tubes are placed in valve actuator slots. The tubing manifold and outlet tube are positioned outside of the range of the anvil mechanism. The pump cover is then closed and the anvils compress the tubing against the rollers. Tubing extending from a fluid reservoir, such as an intravenous fluid bag, is connected to one of the inlet tubes using a connector known in the art such as a quick connect or needle mechanism. Programming the System The system operator programs the system to administer fluids from one or more fluid reservoirs by inputting a rate and order of addition. The system operator is
queried to confirm the date and time of day; to input the program start time, the rate of addition from line 1 , the rate of addition from line 2, the rate of addition from subsequent lines, total fluid to be delivered from each reservoir, the order of fluid addition, priority of fluid addition, and whether addition is continuous or intermittent. The system may also be operated manually or programmed for an initial set-up (e.g., to fill all lines with fluid and expel air). Operation of the System If a patient is being hydrated and fed via a liquid diet as well as receiving medication through an IN. drip, it may be desirable to continually hydrate and medicate the patient but only feed the patient at regular eating intervals. Additionally, the rate of saline administration (i.e., hydration) may be greater than the rate of medication administration. The protocol used in this example is: Start time: 9am Line 1: saline, continuously at 30 mL/hr; Line 2: liquid diet, intermittent at 60 mL/hr for 1.5 hours from 1 l:30am-lpm; and Line 3: medication*, continuously at 0.5 mL/hr. * priority The gear ratio of the infusion pump is set-up such that rotation in the CW direction delivers 0.25 mL per valve opening and rotation in the CCW direction delivers 1 mL per valve opening. Therefore, addition from Line 3, which was assigned priority, will begin promptly at 9am by rotating the motor in the CW direction and opening valve 3 twice every hour (9:00am and 9:30am). Naive 1 will be opened thirty times per hour or once every two minutes by rotating the motor in the CCW direction. It is possible for the motor to change direction and administer both
fluids within a two minute timeframe. Otherwise, sensors would detect insufficient fluid flow and speed up administration until the protocol was back on course. At 11 :30am, following addition of medication from Line 3, which was assigned priority, the liquid diet of Line 2 would be incorporated into the protocol by opening valve 2 once every minute for 90 minutes via rotation of the motor in the CCW direction. The program may provide notification when one or more of the fluid reservoirs is near empty.
Example 2: Alternate addition protocol for use of the present invention in an infusion pump The infusion pump may be set-up and programmed as described above, using the operation parameters described below. Operation of the System A patient receives medication diluted with saline. For example,
Start time: 9am Line 1: saline*, continuously at 65 mL/hr; and Line 2: medication, continuously at 0.5 mL/hr. * priority The gear ratio of the infusion pump is set-up such that rotation in the CW direction delivers 0.25 mL per valve opening and rotation in the CCW direction delivers 1 mL per valve opening. Saline addition from Line 1, which was assigned priority to insure that undiluted medication is never admimstered to the patient, will begin promptly at 9am by rotating the motor in the CCW direction and opening valve 1 sixty times every hour (once per minute). Valve 1 will additionally be opened
twenty times per hour or once every three minutes by rotating the motor in the CW direction. Medication will be administered from Line 2 by opening valve 2 via rotation of the motor in the CCW direction twice per hour (9:30 and 10:00). It is possible for the motor to change direction and administer both fluids within the given timeframe. Otherwise, sensors would detect insufficient fluid flow and speed up administration until the protocol was back on course. The program may provide notification when one or more of the fluid reservoirs is near empty.
All of the concepts, devices and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the concepts, devices and methods of this invention have been described in terms of particular and preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the concepts, devices and methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit and scope of the invention. More specifically, it will be apparent that certain components may be substituted for the components described herein and the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.