The field of the invention is infusion pumps and relates generally to systems, apparatuses, and methods for pumping or infusing volumes of medical fluids to a patient, typically via an intravenous route.
Infusion pumps are used to infuse drugs and liquids into patients, typically via intravenous lines. While some infusion pumps deal with relatively large volumes, there may be more interest in pumps with a capability of delivering only very small controlled volumes of liquid. The drugs used may be very important, such as analgesics, anesthetics including opiates, anti-inflammatory agents, insulin, anti-spasmodic drugs, antibiotics, chemotherapy agents, cardiovascular drugs, and the like. Many of these drugs are needed in very low doses on a continuous basis, so that the patient has a steady, reliable stream over a long period of time, such as 0.1 ml per hour. If pulses are used, the dosage rate may be measured in terms of nanoliters or microliters per pulse or bolus. Patients thus depend on infusion pumps for reliable, consistent delivery of very small volumes.
Some infusion pumps propel or pump the liquid of interest by admitting a quantity of liquid into a length of tubing and isolating that quantity, as by occluding a valve at an inlet of the tubing. A mechanism then opens a valve at an outlet of the tubing and another mechanism compresses or otherwise massages the length of tubing in question. Since the inlet is blocked by the closed valve, the liquid can only exit through the outlet, with an open valve. This method works. However, there are at least two drawbacks to this method. Present day infusion pumps, using this type of shuttle mechanism, may squeeze the length of tubing by pressing a moving shuttle against a stationary block.
In cross-section, the tube resides in a diamond-shaped groove or pumping chamber formed by the opposed shuttle and block. Typically, the profiles of the shuttle and the block, or stationary portion, are not very well suited for maintaining the tube in an ideal position throughout the entire compression cycle. Because of this, the profile of the shuttle and block do not always achieve full compression of the tube at any given point during the pumping cycle. For example, prior art infusion pumps operate by occluding tubing between a moving shuttle and a stationary block. The tubing is not completely occluded because prior art pumps do not entirely compress the tubing, leaving the ends of the tubing non-occluded. This situation has at least two disadvantages: an unpredictable amount of liquid remains in the tubing, negatively affecting pump accuracy, and full pumping capacity is not utilized. Over-squeezing the tubing to complete the occlusion can adversely affect tubing life, while under-squeezing lessens the pumping capacity and may adversely affect pumping volume control accuracy.
Typically, the inlet valve, shuttle, and outlet valves previously mentioned are operated via a single motor or actuator. The timing of the operation of each is accomplished by a mechanical linkage. Accordingly, each stroke of the shuttle mechanism pumps a fixed amount of fluid. Therefore, it is difficult or impossible to adjust the pumping capacity or other pumping characteristic of the pump.
An improved infusion pump is provided in several embodiments.
One embodiment is an infusion pump. The infusion pump includes an inlet valve, an outlet valve, and a shuttle including a shuttle stationary portion and a shuttle moveable portion configured for squeezing a length of tubing between the shuttle stationary portion and the shuttle movable portion, wherein the shuttle moveable portion moves toward and away from the shuttle stationary portion to operate the infusion pump, wherein the shuttle stationary portion and the shuttle moveable portion each include a symmetrical groove for holding and squeezing the length of tubing, the groove symmetrical about a central axis of the groove.
Another embodiment is an infusion pump. The infusion pump includes a housing and contained within the housing, an inlet valve, an outlet valve, and a shuttle including a shuttle stationary portion and a shuttle moveable portion configured for squeezing a length of tubing between the shuttle stationary portion and the shuttle movable portion, wherein the shuttle moveable portion moves toward and away from the shuttle stationary portion to squeeze the tubing, wherein the shuttle stationary portion and the shuttle moveable portion each include a base with a symmetric channel for containing the tubing, each of the shuttle stationary portion and the shuttle movable portion including a plurality of transverse ridges and transverse recesses rising from the base and the channel, wherein a height of the ridges above the channel is less than an outer diameter of the tubing.
Another embodiment is a method of pumping an infusate. The method includes the steps of furnishing an infusion pump, the infusion pump including at least one shuttle having a shuttle stationary portion and a shuttle moving portion, wherein the shuttle stationary portion and the shuttle moveable portion each include a base with a symmetric channel and a plurality of ridges and recesses rising from the base and the channel, wherein the ridges on both sides of the channel are symmetrical. The method also includes controlling operation of the infusion pump by entering commands through at least one input to a controller of the pump, pumping infusate by periodically moving the shuttle moveable portion with respect to the shuttle stationary portion, whereby substantially all of an outer circumference of the tubing is in contact with the portions of the shuttle stationary portion and the shuttle moving portion, and sequentially opening and closing at least one valve of the infusion pump to admit the infusate and to allow the infusion pump to pump the infusate.
Another embodiment is a linear shuttle peristaltic pump. The linear shuttle peristaltic pump includes at least one stationary section, the at least one stationary section including a base, a symmetric channel, at least one ridge on a first side of the channel and at least one recess on a second side of the channel, wherein the channel is formed with symmetrical angles on each side of a center of the channel. The pump also includes a plurality of moveable sections, each moveable section including a base, a symmetric channel, a ridge on a first side of the channel and a recess on a second side of the channel, wherein the channel is formed with symmetrical angles on each side of a center of the channel, and wherein the at least one ridge and at least one recess in the at least one stationary section fit into the recesses and ridges of the moveable sections, and wherein when the at least one stationary section and the plurality of movable sections are assembled, the channels form an opening suitable for a length of tubing, whereby substantially all of an outer circumference of the tubing is in contact with portions of the at least one stationary section and portions of the moving sections when the moving sections operate to squeeze the length of tubing, and a plurality of linear actuators connected to the plurality of moveable sections, each of the plurality of linear actuators further including a sensor for reporting a position of the actuator. In another embodiment, the linear actuators are replaced with a single motor and a cam in contact with each of the plurality of moveable sections.
Another embodiment is a method of pumping a liquid. The method includes the steps of providing a linear shuttle peristaltic pump, the pump including a plurality of shuttle stationary sections and a plurality of shuttle moving sections, each of the sections having a symmetric groove with at least one transverse ridge and at least one transverse recess, wherein the ridges and the recesses of the stationary sections fit into matching recesses and ridges of the moving sections, and wherein substantially all of an outer circumference of tubing in the pump is in contact with surfaces of the stationary sections and the moving sections when the tubing is squeezed. The method also includes controlling operation of the linear shuttle peristaltic pump by entering commands through at least one input to a controller of the pump, pumping liquid by sequentially moving the shuttle moveable sections with respect to the shuttle stationary sections, and sequentially opening and closing at least one valve of the infusion pump to admit the infusate and to allow the infusion pump to pump the infusate.
Another embodiment is a geometry-controlled valve. The valve includes a stationary section, the stationary section including a base, a symmetric channel, at least one ridge on a first side of the channel and at least one recess on a second side of the channel, wherein the channel is formed with symmetrical angles on each side of a center of the channel, and a moveable section, the moveable section including a base, a symmetric channel, a ridge on a first side of the channel and a recess on a second side of the channel, wherein the channel is formed with symmetrical angles on each side of a center of the channel, and wherein the at least one ridge and at least one recess in the stationary section fit into the recesses and ridges of the moveable section, and wherein when the stationary section and the movable section are assembled, the channels form an opening suitable for a length of tubing, whereby substantially all of an outer circumference of the tubing is in contact with the portions of the stationary section and the moving section when the moving section operates to squeeze the length of tubing.
Additional features and advantages are described herein, and will be apparent from, the following Detailed Description and the Figures.
One embodiment is depicted in
The first infusion pump 14 receives liquid from a first container 34 and the second infusion pump 16 receives liquid from a second container 36. The flow of liquid is then conveyed to the respective infusion pump via tubing 348, 366. The tubing 348, 366 in this embodiment is continuous before and after the infusion pumps 14, 16 and extends to an access device connector 368 for each line. The access device connector 368 may be a vascular access device and may be used for administering a drug or other medicament to the patient.
The system controller is a microcontroller 28, which includes a central processing unit (CPU), input/output capability (I/O), digital to analog converter (D/A), and random access memory (RAM) and read-only memory (ROM), and may include additional memory (MEM). A computer program for operating one or more infusion pumps 14, 16 is stored in MEM or ROM. Microcontroller 28 receives inputs from the drip counters 342, to monitor the input to the infusion pumps. The microcontroller 28 also receives inputs from a number of sensors or devices associated with the infusion pumps 14, 16, such as encoder data from rotary encoders on a motor driving the infusion pump, linear voltage displacement transducer (LVDT) data or other position or displacement data from linear actuators, voltage or current readings from temperature or pressure sensors in the infusion pumps 14, 16, and the like. The data may be sent via wire harnesses 322, 324, 326, or may be wireless, such as wireless signals conforming to the ZigBee/IEEE 805.15.4 wireless standard. The data may be received by the microcontroller 28 or the microcontroller 28 may include a separate interface for sensor circuits 32, as shown. The infusion pumps 14, 16 in this embodiment have a separate section for driver circuits 30, for driving or controlling linear actuators, rotary actuators, motors, and the like.
Infusion pump 14 is driven by a motor 148 driving an infusion pump moveable shuttle section 144 by a camming drive train 146. The moveable shuttle section 144 squeezes tubing 348 against the shuttle stationary section 142 to pump the liquid from container 34. Upper valve 140 opens to admit liquid into the tubing 348 and closes when the tubing 348 is full. Lower valve 141 then opens just before the controller 28 commands infusion pump 14 to actuate and cycle the moveable shuttle section 144. With upper valve 140 closed and lower valve 141 open, the liquid is forced through the lower valve and downstream through connector 368. An encoder or other feedback device on motor 148 informs controller 28 of the position of the motor 148, and thus the position of the moveable shuttle section 144, and also allows calculation of volume pumped by the infusion pump 14 by the computer program.
The second infusion pump 16 operates with linear actuators. A linear actuator is a device that develops force and motion, from an available energy source, in a linear manner, as opposed to a device that operates in a rotary manner, as one that receives torque directly from a rotary electric motor. Examples of linear actuators include electric linear solenoids, linear pneumatic actuators, and hydraulic cylinders. Other examples include ball screws and jack screws, and also cylinders actuated by a linear motor. Infusion pumps as described herein place a premium on space and on reliability. While many types of linear actuators may be used, lead screws and stepper motors from and Haydon Switch & Instrument (HSI) of Waterbury, Conn., U.S.A. and from Portescap, West Chester, Pa., U.S.A., have been found useful for the present infusion pump application.
Infusion pump 16 includes a stationary portion 162 and two moveable shuttles 164, 166, as well as three valves 160, 165, and 170, and five linear actuators 168. The commands to the linear actuators 168 and their positions are reported via harness 326 to the driver circuit portion 30 and are also reported to the microcontroller 28. Infusion pump 16 receives liquid from container 36 and drip chamber 346 and pumps via tubing 366. In this embodiment, tubing 366 is a continuous piece of tubing 366 from the drip chamber 346 to connector 368. Valve 165 closes and valve 160 opens to admit liquid into the tubing 366 downstream from valve 160. When this portion of the tubing 366 is full, valve 160 closes, valve 165 opens, and shuttle 164 advances, pumping liquid downstream through valve 165. Shuttle 166 is open to receive the liquid and valve 170 is closed. Then valve 165 closes, valve 170 is opened, and shuttle 166 closes, pumping the liquid downstream to connector 368 and to the patient. While shuttle 166 is closing, shuttle 164 retracts and valve 160 opens, admitting liquid upstream from valve 165. The process is then repeated, with sequential advance and retraction of the shuttles and appropriate opening and closing of the valves.
The use of two shuttles smoothes the pumping process, so that part of the tubing is being pumped (emptied) while the remainder is being filled. When the first shuttle 164 pumps, the contents of the upper portion of the tubing 366 are discharged into the lower portion of the tubing 366 adjacent the second shuttle 166. When the second shuttle 166 is pumping liquid to the patient, the tubing adjacent the first shuttle 164 is being re-filled. The tubing is quickly filled because the liquid has only to traverse the tubing immediately adjacent the first shuttle 164. Using this technique, a smooth, virtually continuous flow is achieved. In this embodiment, intermediate valve 165 acts as both the outlet valve for upper shuttle 164 and as input valve for lower shuttle 166.
Prior art infusion pumps, such as the one shown in cross-section in
The block 40 and the shuttle 42 are each made of a base with a plurality of alternating ridges 46 and recesses 48, with a central channel 44. The ridges 46 of one portion fit into the recesses 48 of the other, allowing sliding movement of the moving shuttle 42 with respect to the stationary block 40. The central channel 44 is configured for receiving a length of tubing, and should have a generous radius and be free from nicks and burrs. The ridges 46 rise perpendicularly from the base at the top and bottom edges of block 40 and shuttle 42, but form an angle B to the central channel of about 45 degrees. In this embodiment, the angles B and the channel are symmetrical with respect to a horizontal plane H bisecting the central channel, i.e., angles B are equal. The sum of the two angles B is from about 60 degrees to about 120 degrees. The tubing will be held or contained in a symmetrical manner, helping to insure that the tubing is not distorted when pumping takes place.
As seen in
Another embodiment of a block 410 and a shuttle 420 are shown in
The block 410 and shuttle 420 described above may also be made and used in smaller portions for occluding the tubing 38. For example, instead of squeezing a longer portion of the tubing 38 for pumping, a much shorter version may be used as a valve.
Another embodiment of an occluder that is capable of acting as a valve is depicted in
Other linear actuation embodiments are depicted in
When the primary shuttle has finished pumping and is being replenished, inlet valve 152 is opened and intermediate valve 154 is closed. The secondary shuttle 166 continues the delivery of the fluid. Later, when the intermediate valve is open and the inlet valve is closed, the primary shuttle pumps fluid and fills the secondary shuttle 166. Since the primary shuttle is twice as long and encounters twice the length of tubing, it pumps about twice as much volume as the secondary shuttle. Other embodiments may be used.
The linear movement of the shuttles and valves described in the above embodiments is easy to understand. However, there are also embodiments in which the tubing for an infusion pump is squeezed or actuated by rotary motion, using a shuttle 420 as depicted in
Such an embodiment is further depicted in
Side views of closed and open positions of this embodiment are further shown in
It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
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International Search Report for International Application No. PCT/US 02/36963 of Applicant Baxter International Inc. |
International Search Report for International Application No. PCT/US 02/36964 of Applicant Baxter International Inc. |
International Search Report for International Application No. PCT/US2010/062150 of Applicant Baxter International Inc. |
Written Opinion in PCT Application PCT/US2010/062150, mailed Jul. 21, 2011 (9 pages). |
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International Search Report for International Application No. PCT/US2010/062150 of Applicant Baxter International Inc. dated Dec. 22, 2011. |
Number | Date | Country | |
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20110158823 A1 | Jun 2011 | US |