GEL COUPLING FOR ELECTROKINETIC DELIVERY SYSTEMS

BACKGROUND

Pumping systems are important for chemical analysis, drug delivery, and analyte sampling. However, traditional pumping systems can be inefficient due to a loss of power incurred by movement of a mechanical piston. For example, as shown in FIGS. 2B and 3B, when a piston 203 is used between two diaphragms 254, 252, the piston 203 typically pushes and pulls on part of the diaphragms 254, 252, thus expanding and contracting in and out of a pumping chamber 122. This contraction and expansion pumps the fluid. Inefficiencies occur, however, because the mechanical piston 203 can only actuate the areas of the diaphragms 252, 254 with which it has contact. Other parts 255 of the diaphragms 252, 254 that are not acted upon on by the piston 203 are left to flex freely as the piston 203 is moving. As a result, fluid in contact with or near these areas of the diaphragm is unable to move, therefore robbing efficiency from the pump.

Some diaphragm designs try to compensate for such inefficiencies by using a stiffer material to avoid having the diaphragm freely flexing. This approach, however, makes the diaphragm more difficult to actuate and tends to still lower efficiency. Other conventional diaphragm designs, such as a rolling diaphragm, are easy to actuate but have larger dead volumes.

Traditional systems can also be disadvantageous because they cannot precisely deliver small amounts of delivery fluid, partly because a mechanical piston cannot be accurately stopped mid-stroke.

Moreover, traditional pumping systems can be disadvantageous because they are often large, cumbersome, and expensive. Part of the expense and size results from the fact that the current pumping systems require the engine, pump, and controls to be integrated together.

Accordingly, a pumping system is needed that is highly efficient, precise, and/or modular.

SUMMARY OF THE DISCLOSURE

In general, in one aspect, a fluid delivery system includes a first chamber, a second chamber, and a third chamber, a pair of electrodes, a porous dielectric material, an electrokinetic fluid, and a flexible member including a gel between two diaphragms. The pair of electrodes is between the first chamber and the second chamber. The porous dielectric material is between the electrodes. The electrokinetic fluid is configured to flow through the porous dielectric material between the first and second chambers when a voltage is applied across the pair of electrodes. The flexible member fluidically separates the second chamber from the third chamber and is configured to deform into the third chamber when the electrokinetic fluid flows form the first chamber into the second chamber.

This and other embodiments can include one or more of the following features. The flexible member can be configured to deform into the second chamber when the electrokinetic fluid moves from the second chamber to the first chamber. A void can occupy 5-50% of a space between a deformable portion of the first and second diaphragms. The gel material can be adhered to the first and second diaphragms. The gel material can be separable from the first or second diaphragms when a leak forms in the first or second diaphragms. The gel material can include silicone, acrylic PSA, silicone PSA, or polyurethane. The diaphragm material can include a thin-film polymer. A ratio of a diameter of the third chamber to a height of the third chamber can be greater than 5/1. A thickness of the gel in a neutral pumping position can be greater than a height of the third chamber. The flexible member can be configured to pump a deliver fluid from the third chamber when the voltage is applied across the first and second electrodes. The flexible member can be configured to stop deforming substantially instantaneously when the electrokinetic fluid stops flowing between the first and second chambers. The flexible member can be configured to at least partially conform to an interior shape of the third chamber. The gel can be configured to compress between the first and second diaphragms when the flexible member pumps fluid from the third chamber.

In general, in one aspect, a fluid delivery system includes a pump module having a pumping chamber therein, a pump engine configured to generate power to pump delivery fluid from the pumping chamber, and a flexible member. The flexible member fluidically separates the pump module from the pump engine and is configured to deflect into the pumping chamber when pressure is applied to the flexible member from the pump engine. The flexible member is configured to transfer more than 80% of an amount of power generated by the pump engine to pump delivery fluid from the pumping chamber.

This and other embodiments can include one or more of the following features. The pump engine can be an electrokinetic engine. The flexible member can include a gel between two diaphragms.

In general, in one aspect, a method of pumping fluid includes applying a first voltage to an electrokinetic engine to deflect a flexible member in a first direction to draw fluid into a pumping chamber of an electrokinetic pump, the flexible member comprising a gel between two diaphragms; and applying a second voltage opposite to the first voltage to the electrokinetic engine to deflect the flexible member into the pumping chamber to pump the fluid out of the pumping chamber.

This and other embodiments can include one or more of the following features. The method can further include stopping the application of the second voltage and stopping the pumping of fluid out of the pumping chamber substantially instantaneously with stopping the application of the second voltage. The method can further include compressing the gel between the first and second diaphragms when the flexible member is deflected into the pumping chamber. The method can further include applying the second voltage until the flexible member substantially conforms to an interior surface of the pumping chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

FIG. 1 is a schematic view of a pump system having a gel coupling in a neutral position;

FIG. 2A is a schematic view of a gel coupling in the outtake position to deliver fluid;

FIG. 2B is a schematic view of the movement of a traditional piston in the outtake position to deliver fluid;

FIG. 3A is a schematic view of a gel coupling in an intake position to draw fluid into the pump;

FIG. 3B is a schematic view of the movement of a traditional piston in an intake position to draw fluid into the pump;

FIG. 4 is a schematic view of a partial stroke of a gel coupling;

FIG. 5A is a schematic view of an electrokinetic (“EK”) system having a gel coupling in a neutral position;

FIG. 5B is a schematic view of the EK system of FIG. 5A with the gel coupling in the intake position;

FIG. 5C is a schematic view of the EK system of FIG. 5A with the gel coupling movable member in the outtake position;

FIG. 5D is a close-up of the movable member of FIG. 5A;

FIG. 6 shows the modularity of the assembly of pumps having a gel coupling movable member;

FIG. 7 is an exploded view of a control module for an EK pump module;

FIG. 8 is a schematic diagram of the electrical connections between components of an EK pump module and components of a control module.

FIG. 9A is a top view of a modular EK pump. FIG. 4B is an exploded view of the modular EK pump of FIG. 9A.

FIG. 10 shows an exemplary connection between a control module and an EK pump module.

FIG. 11 is a schematic diagram of the electrical connections between components of an EK pump module and a control module including connections between a module identifier and the control module.

DETAILED DESCRIPTION

Certain specific details are set forth in the following description and figures to provide an understanding of various embodiments of the invention. Certain well-known details, associated electronics and devices are not set forth in the following disclosure to avoid unnecessarily obscuring the various embodiments of the invention. Further, those of ordinary skill in the relevant art will understand that they can practice other embodiments of the invention without one or more of the details described below. Finally, while various processes are described with reference to steps and sequences in the following disclosure, the description is for providing a clear implementation of particular embodiments of the invention, and the steps and sequences of steps should not be taken as required to practice this invention.

FIG. 1 is a schematic view of a pump system 100. The pump system 100 includes a fluid pump 191 configured to deliver fluid from a fluid reservoir and a pump engine 193 configured to supply the power necessary to run the fluid pump 191. A gel coupling 112 is located between the fluid pump 191 and the pump engine 193. The gel coupling 112 is configured to transfer power from the pump engine 193 to the fluid pump 191, i.e., similar to the movement of a piston. The gel coupling 112 can include a gel-like material 150 bounded by a front diaphragm 154 and a rear diaphragm 152. Further, the diaphragms 152, 154 can be pinned between the pump 191 and the engine 193 along the outer edges such that the middle portion of the gel coupling is free to flex between the pump 191 and the engine 193 to transfer power from the engine 193 to the pump 191.

The diaphragms 152, 154 of the gel coupling 112 can be aligned substantially parallel with one another when in the neutral position shown in FIG. 1 and can have approximately the same dimensions as one another, such as the same length or diameter. Providing diaphragms that are aligned and have approximately the same dimensions allows the diaphragms to be properly coupled such that all of the power transferred from one diaphragm can be received by the other diaphragm. The diaphragms 152, 154 can be made of a thin material, e.g., less than 10 ml thick, such as less than 5 ml thick. Further, the diaphragms 152 can be made of an elastic and/or flexible material. In some embodiments, the diaphragms are made of a thin-film polymer, such as, polyethylene, silicone, polyurethane, LDPE, HDPE, or a laminate. In one embodiment, at least one of the diaphragms is made of a laminated material having a polyethylene layer adhered to a nylon layer, such as WinPak Deli*1™. Thin film polymers can advantageously improve flexibility of the gel coupling 112 as well as improve adhesion of the diaphragms to the gel-like material 150. In a specific embodiment, the diaphragms 152, 154 are made of a polyethylene film that is approximately 4 ml thick. In another specific embodiment, the diaphragms 152, 154 are made of a WinPak Deli*1™ film that is approximately 3 ml thick. The diaphragms 152, 154, in addition to transferring energy from the engine 193 to the pump 191, can also have a low moisture transmission rate and therefore function to prevent fluid, e.g., pump fluid from an EK engine or delivery fluid, from leaking out of the respective components.

The gel-like material 150 can include a gel, i.e. a dispersion of liquid within in a cross linked solid that exhibits no flow when in the steady state. The liquid in the gel advantageously makes the gel soft and compressible while the cross-linked solid advantageously makes the gel have adhesive properties such that it will both stick to itself (i.e. hold a shape) and stick to the diaphragm material. The gel-like material 150 can have a hardness of between 5 and 60 durometer, such as between 10 and 20 durometer, for example 15 durometer. Further, the gel-like material 150 can have adhesive properties such that it is attracted to the material of both diaphragms 152, 154, which can advantageously help synchronize the two diaphragms 152, 154. In some embodiments, the gel-like material 150 is a silicone gel, such as blue silicone gasket material from McMaster-Carr® or Gel-Pak® X8. Alternatively, the gel-like material 150 can include a pressure sensitive adhesive (PSA), such as 3M™ acrylic PSA or 3M™ silicone PSA. In other embodiments, the gel-like material can be a low durometer polyurethane.

The gel-like material 150 can have a thickness that is low enough to remain relatively incompressible, but high enough to provide proper adhering properties. For example, the gel-like material 150 can be between 0.01 to 0.1 inches thick, such as between 0.01 and 0.06 inches thick. In one embodiment, the flexible member, including the gel, has a thickness that is greater than the height of the pumping chamber 122. For example, the thickness of the gel coupling 112 can be approximately 1.5 to 2 times the height of the pumping chamber 122. The gel-like material can have a Poisson's ratio of approximately 0.5 such that, when compressed in one direction, it expands nearly or substantially the same amount in a second direction. Further, the gel-like material 150 can be chemically stable when in contact with the diaphragms 152, 154 and can be insoluble with water, pump fluids, or delivery fluids.

Referring to FIG. 2A, the gel coupling 112 can be flexible so as to deform or deflect towards the pump 191 when positive pressure is placed upon the member 112 by the pump engine 193. Thus, as the positive pressure is applied to the gel coupling by the pump engine 193, at least a portion of the gel coupling 112 will move into the chamber 122 of the fluid pump 191 and at least partially conform to the shape of the chamber 122, thereby pump fluid 145 out of the chamber 122. The flexibility of the gel coupling 112 can advantageously reduce the amount of dead volume 144, i.e. volume of pump fluid 145 not displaced by the gel coupling 112, caused during pumping, thereby improving the efficiency of the pump relative to a mechanical piston. That is, referring to FIG. 2B, a system 200 having a mechanical piston 203 between two diaphragms 252, 254 can create a significant amount of dead volume 244 as the piston is pumped by the engine 293 due to the unsupported portions 255 of the diaphragms 252, 254 that cannot push fluid and rather flex freely as the piston moves. In contrast, the gel coupling 112 having the gel-like material 150 has significantly less dead volume 144 because the gel 150 can compress between the diaphragms 152, 154, reducing the distance between the diaphragms, and expand laterally. This expansion laterally causes the area of the diaphragm 154 that would be unsupported by the piston 203 (FIG. 2B) to be supported by the expanded gel-like material 150 (FIG. 2A), allowing more fluid to flow out of the pump 191.

Referring to FIG. 3A, during the reverse stroke, when negative pressure is placed upon the flexible member by the pump engine 193, the flexible member 112 can again be flexible so as to deform. Thus, as the diaphragm 154 pulls back on the gel-like material 150, the adhesion properties of the gel-like material 150 will transfer the pulling force to the diaphragm 152 and pull pump fluid 145 into the chamber 122. The gel-like material 150 advantageously pulls in areas where a mechanical piston would not. That is, referring to FIG. 3B, the piston 203 driven in reverse will pump a volume of pump fluid 245 equal to the size of the piston, as shown by the dotted line 333. However, the areas 255 of the membranes 254, 252 unsupported by the piston 203 will not move as much and will therefore create a stagnant or dead volume 244, which will result in less fluid 245 being pumped into the chamber 122. In contrast, the gel-coupling gel coupling 112 will remain adhered to the diaphragms 152, 154 in the laterally expanded state. Thus, as shown in FIG. 3A, as the diaphragm 152 pulls on the gel-like material 150, the center of the gel-like material will thin while the edges remain adhered to the diaphragms 152, 154. Accordingly, more of the diaphragm 154 will pull on fluid 145 into the pumping chamber (shown by the dotted line in FIG. 3A) relative to that pulled in by the piston 203 (shown by the dotted line in FIG. 3B).

In some embodiments, the gel coupling 112 can be located within a fixed volume space, such as the chamber 122, so that movement of the gel coupling 112 is limited by the fixed volume. In some embodiments, the expanded shapes of the diaphragms 152, 154 limit the amount of movement of the gel coupling 112. For example, the diaphragms 152, 154 can include a thin polymer with a low bending stiffness but a high membrane stiffness such that the gel coupling 112 can only move a set distance. Having a shaped diaphragm can be advantageous because the shaped diaphragm undergoes little stretching, and stretching can problematically cause the gel-like material to decouple from the diaphragm after several cycles of stretching.

The gel coupling 112 can be configured to move only based upon the amount of power supply by the engine 193. That is, because the gel coupling 112 is pliable and has little inertia and mechanical stiffness to overcome, it can stop substantially instantaneously when the engine 193 stops generating power. The gel coupling 112 will only have to overcome a small local pressure in order to actuate the drive volume and/or stop pumping. As a result, referring to FIG. 4, the gel coupling 112 can be stopped mid-stroke, i.e. before reaching the edge of the chamber 122, to displace only a small volume of fluid 145. For example, less than 20% of the total stroke volume can be displaced, such as less than 10%, such as approximately 5%.

In one embodiment, referring to FIG. 5A, the gel coupling 112 can be used in an electrokinetic (“EK”) pump system 300. The EK pump system 300 includes a pump 391 and an EK engine 393. The engine 393 includes a first chamber 102 and a second chamber 104 separated by a porous dielectric material 106, which provides a fluidic path between the first chamber 102 and the second chamber 104. Capacitive electrodes 108a and 108b are disposed within the first and second chambers 102, 104, respectively, and are situated adjacent to or near each side of the porous dielectric material 106. The electrodes 108a, 108b can comprise a material having a double-layer capacitance of at least 10⁻⁴Farads/cm², such as at least 10⁻²Farads/cm². The EK engine 393 further includes a movable member 110 opposite the electrode 108a, for example a flexible impermeable diaphragm. The first and second chambers 102 and 104, including the space between the porous dielectric material 106 and the capacitive electrodes 108a and 108b, are filled with an electrolyte or EK pump fluid. The pump fluid may flow through or around the electrodes 108a and 108b. The capacitive electrodes 108a and 108b are connected to an external voltage source by lead wires or other conductive media.

The pump 391 further includes a third chamber 122. The third chamber 122 can include a delivery fluid, such as a drug, e.g., insulin. A supply cartridge 142 can be connected to the third chamber 102 for supplying the delivery fluid to the third chamber 122, while a delivery cartridge 144 can be connected to the third chamber 122 for delivering the delivery fluid from the third chamber 122, such as to a patient. The gel coupling 112 can separate the delivery fluid in the third chamber 122 and the pump fluid in the second chamber 104.

The pump system 300 can be used to deliver fluid from the supply cartridge 142 to the delivery cartridge 144 at set intervals. To start delivery of fluid, a voltage correlating to a desired flow rate and pressure profile of the EK pump can be applied to the capacitive electrodes 108a and 108b from a power source. A controller can control the application of voltage. For example, the voltage applied to the EK engine 393 can be a square wave voltage. In one embodiment, voltage can be applied pulsatively, where the pulse duration and frequency can be adjusted to change the flow rate of EK pump system 300. The controller, in combination with check valves 562 and 564 and pressure sensors 552 and 554 can be used to monitor and adjust the delivery of fluid. Mechanisms for monitoring fluid flow are described further in U.S. patent application Ser. No. ______, filed herewith, and titled “SYSTEM AND METHOD OF DIFFERENTIAL PRESSURE CONTROL OF A RECIPROCATING ELECTROKINETIC PUMP.”

Referring to FIG. 5A, the gel coupling 112 in the EK system 300 can be in a neutral position in the chamber 112. Referring to FIG. 5B, as a voltage, such as a forward voltage, is applied to the electrodes 108a, 108b, pump fluid from the second chamber 104 is moved into the first chamber 102 through the porous dielectric material 106 by electro-osmosis. The movement of pump fluid from the second chamber 104 to the first chamber 102 causes the movable member 110 to expand from a neutral position shown in FIG. 5A to an expanded position shown in FIG. 5B to compensate for the additional volume of pump fluid in the first chamber 102. Further, because the gel coupling 112 is in fluid communication with the pump fluid, it will be pulled towards the EK engine 393, as shown in FIG. 5B. When the gel coupling 112 has been pulled all the way, a fixed volume of delivery fluid can be pulled from the supply cartridge 142 into the third chamber 122 (called the “intake stroke”).

Referring to FIG. 5C, the flow direction of pump fluid can be reversed by toggling the polarity of the applied voltage to capacitive electrodes 108a and 108b. Thus, applying a reverse voltage (i.e., toggling the polarity of the forward voltage) to the EK engine 393 causes the pump fluid to flow from the first chamber 102 to the second chamber 104. As a result, the movable member 110 is pulled from the expanded position shown in FIG. 5B to the retracted position shown in FIG. 5C. Further, the gel coupling 112 is pushed by the pump fluid from the intake position of FIG. 5B to the delivery position of FIG. 5C. In this position, the gel-like material 150 fully compresses, causing the gel coupling 112 to substantially conform to the shape of the third chamber 122 and support areas of the diaphragm that would otherwise be unsupported. As a result, the volume of delivery fluid located in the third chamber 122 is pushed into the delivery cartridge 144, for example, for delivery to a patient (called the “outtake stroke”).

The EK pump system 300 can be used in a reciprocating manner by alternating the polarity of the voltage applied to capacitive electrodes 108a and 108b to repeatedly move the gel coupling 112 back and forth between the two chambers 102, 104. Doing so allows for delivery of a fluid, such as a medicine, in defined or set doses.

When the electrokinetic pump system 300 is used as a drug administration set, the supply chamber 142 can be connected to a fluid reservoir 141 and the delivery chamber 144 can be connected to a patient, and can include all clinically relevant accessories such as tubing, air filters, slide clamps, and back check valves, for example.

The electrokinetic pump system 300 can be configured to stop pumping in a particular direction, i.e. with negative or positive current, prior to the occurrence of a Faradaic process in the liquid. Accordingly, the electrodes will advantageously not generate gas or significantly alter the pH of the pump fluid. The set-up and use of various EK pump systems are further described in U.S. Pat. Nos. 7,235,164 and 7,517,440, the contents of which are incorporated herein by reference.

Referring to FIGS. 5D and 6, the gel coupling 112 can be pinned or attached into the system 300 between the pump 391 and the engine 393. For example, a spacer 165, such as a spacing ring, can clamp the upper diaphragm 154 to the pump 391 and the lower diaphragm 152 to the engine 393. An adhesive 551 can attach the diaphragms 152, 154 to the spacer 165. The gel-like material 150 can sit inside of the spacer 165 and between the two diaphragms 152, 154. The attachment of the diaphragms 152, 154 only at the outer diameter allows the gel coupling 112 to flex or deform in the central region when pressure is applied on either side of the coupling 112.

As shown in FIG. 5D, the gel 150 can extend only part of the diameter or length of the diaphragms 152, 154. A void 163 filled with air can be located between the two diaphragms, such as between the spacer 165 and the gel-like material 150. As shown, the gel-like material 150 can occupy approximately 50% to 95%, such as 70% to 80%, of the space between the movable portions of the two diaphragms 152, 154, while the void 163 can occupy the rest of the space, such as 5-50% or 20-30%. The void 163 is advantageous because the gel-like material 150, when it compresses and expands laterally, has a place to expand into. Further, the void 163 is advantageous because, if there is a leak in one of the diaphragms 152/254, the void 163 provides a place for the fluid to flow, thereby wetting the gel-like material 150 and allowing it to separate from one or both of the diaphragms 152/154 to stop the pump from pumping. In one embodiment, the system includes a weep-hole connected to the void 163, such as through the spacer 165, such that leaking fluid can flow out of the system.

In one embodiment, shown in FIG. 5D, the pumping chamber 122 is pre-shaped in a flattened dome structure, and the gel-like material 150 extends approximately the width w of the flattened portion. In another embodiment, the diaphragms 152, 154 are pre-shaped in the flattened dome structure, and the gel similarly aligns with the width of the flattened portion. In these embodiments, the gel-like material 150, when compressed against the diaphragms, can be configured to spread out into the sloped portions, such as shown in FIG. 2A. Thus, the gel-like material 150 can expand to fill in and support substantially all of the exposed area of the diaphragm 154.

Referring to FIG. 5D, the chamber 122 can have a large diameter d relative to its height h. For example, the ratio of the diameter to the height can be greater than 3/1, such as greater than 5/1, such as between 6/1 and 20/1, such as approximately 15/1. By having a large diameter relative to the height, the diaphragms 152, 154 will advantageously have less unsupported area. As a result, a chamber of the substantially the same volume but a greater diameter/height ratio can advantageously deliver more fluid because more of the area of each of the diaphragms will be involved in pulling and pumping fluid. For example, a flattened dome-shaped chamber of 0.2 inches in diameter by 0.03 inches high and wall angle of approximately 45 degrees can deliver about 30 μl of fluid, which is about 90% of the calculated volume of the chamber. In contrast, a flattened dome-shaped chamber of 0.275 inches in diameter by 0.02 inches high and a wall angle of approximately 45 degrees can deliver about 45 μl of fluid, which is about 99% of the calculated volume. Having a pumping chamber with a large diameter relative to the height can also advantageously make the system “self-priming,” i.e. create a low enough “dead volume” that the system does not have to be flushed prior to use to remove unwanted air.

Advantageously, having a gel coupling in a pump system can serve to separate any fluid in the engine, such as electrolyte in an EK pump, from delivery fluid in the pump. Separating the fluids ensures, for example, that pumping fluid will not accidentally be delivered to a patient.

Moreover, if a crack or hole is formed in either diaphragm of the gel coupling, the gel-like material will separate from the diaphragms. Since the gel-like material is lightly adhered to the diaphragm due to the adhesive properties of the gel material, such as through Van der Waal forces, it can separate from the diaphragms easily when wetted. Thus, if a diaphragm breaks or has a pin hole, either the pumping liquid or the delivery liquid can seep into the area where the gel is located. The liquid will then cause the gel and diaphragms to separate, thus causing the pump system to stop working. This penetration can be enhanced by having a void between the diaphragms filled with air, as the wetting agent can fill in the void to keep the pump system from working. Having the pump system stop working all together advantageously ensures that the pump is not used while delivering an incorrect amount of fluid, providing a failsafe mechanism.

The low durometer of the gel-like material advantageously allows for strong coupling between the two diaphragms of the gel coupling. That is, because the gel-like material has a low durometer and low stiffness, any change in shape of one diaphragm can be mimicked by the gel-like material and thus translated to the other diaphragm. The low durometer, in combination with the adhesive properties of the gel material, allows more than 50%, such as more than 80% or 90%, for example about 95%, of the power generated by the pump engine to be transferred to the delivery fluid. This high percentage is in contrast to mechanical pistons, which generally only transfer 40-45% of the power created by the piston. Further, because the gel coupling can transfer a high percentage of the power, the gel coupling is highly efficient. For example, a gel coupling in an electrokinetic pump system can pump at least 1200 ml of delivery fluid when powered by 2 AA alkaline batteries using 2800 mAh of energy. The gel coupling in an electrokinetic pump can further pump at least 0.15 mL, such as approximately 0.17 mL, of delivery fluid per 1 mAh of energy provided by the power source. Thus, for hydraulically actuated pumps such as an electrokinetic pump, the gel coupling can achieve nearly a one-to-one coupling such that whatever pump fluid is moved through the engine is transferred to the same amount of fluid being delivered from the pump.

Further, the gel coupling, when used with an electrokinetic pump system, advantageously allows for the pump to provide consistent and precise deliveries that are less than a full stroke. That is, because the EK engine delivers fluid only when a current is present, and because the amount of movement of the gel coupling is dependent only on the amount of pressure placed on it by the pump fluid rather than momentum, the gel coupling can be stopped “mid-stroke” during a particular point in the pumping phase. Stopping the gel coupling mid-stroke during a particular point in the pumping phase allows for a precise, but smaller amount of fluid to be delivered in each stroke. For example, less than 50%, such as less than 25%, for example approximately 10%, of the volume of the pumping chamber can be precisely delivered. The ability to deliver a precise smaller amount of fluid from an EK pumping system advantageously increases the dynamic range of flow rates available for the pump system.

The gel coupling is advantageously smaller than a mechanical piston, allowing the overall system to be smaller and more compact.

The coupling of the engine and pump together in the gel coupling advantageously allows the engine, such as the EK engine, and the pumping mechanism to be built separately and assembled together later. For example, as shown in FIG. 6, the pump 391 can be separate from the engine 393. After the pump 391 and engine 393 have been separately assembled (e.g., the pump 391 could be prefilled with pump fluid), then the overall system 300 can be assembled by placing the gel-like material 150 in between the pump 391 and the engine 393. The entire system can be connected with a set of screws. The coupling can also advantageously allow the same engine to be used with multiple pumps. Further, the coupling can advantageously allow the pumping mechanism to be pre-filled and then attached to the EK pump.

In addition to the gel coupling, the modularity of the overall system can be increased by having separable controls and pump systems. For example, referring to FIG. 7, a control module 1200 can be configured to apply the voltage necessary to pump fluid through the EK pump module (which includes both the EK pump and the EK engine discussed above). The control module 1200 can include a power source, such as a battery 1203, for supplying the voltage, and a circuit board 1201 including the circuitry to control the application of voltage to the pump module. The control module can further include a display 1205 to provide instructions and/or information to the user, such as an indication of flow rate, battery level, operation status, and/or errors in the system. An on-off switch 1207 can be located on the control module to allow the user to switch the control module on and off.

Referring to FIG. 8, the circuit board in the control module 1200 includes voltage regulators 1301, an H-bridge 1303, a microprocessor 1305, an amplifier 1307, switches 1309, and communications 1311. Electrical connections 1310 between the components of the control module 1200 and components of the pump module 1100 enable the control module 1200 to run the pump module 1100. The control module can provide between 1 and 20 volts, such as between 2 and 15 volts, for example 2.6 to 11 volts, specifically 3 to 3.5 volts, and up to 150 mA, such as up to 100 mA, to the pump module 1100.

In use, the batteries 1203 supply voltage to the voltage regulators 1301. The voltage regulators 1301, under direction of the microprocessor 1305, supply the required amount of voltage to the H-bridge 1303. The H-Bridge 1303 in turn supplies voltage to the EK engine 1103 to start the flow of fluid through the pump. The amount of fluid that flow through the pump can be monitored and controlled by the pressure sensors 1152, 1154. Signals from the sensors 1152, 1154 to the amplifier 1307 in the control module can be amplified and then transmitted to the microprocessor 1305 for analysis. Using the pressure feedback information, the microprocessor 1305 can send the proper signal to the H-bridge to control the amount of time that voltage is applied to the engine 1103. The switches 1309 can be used to start and stop the engine 1103 as well as to switch between modes of pump module operation, e.g., from bolus to basal mode. The communications 1311 can be used to communicate with a computer (not shown), which can be used for diagnostic purposes and/or to program the microprocessor 1305.

As shown in FIG. 8, the pump module 1100 and the control module 1200 can have at least eight electrical connections extending therebetween. A positive voltage electrical connection 1310a and a negative voltage electrical connection 1310b can extend from the H-bridge 1303 to the engine 1103 to supply the appropriate voltage. Further, an s+ electrical connection 1310c, 1310g and an s− electrical connection 1310d, 1310h can extend from sensors 1152, 1154, respectively, such that the difference in voltage between the s+ and s− connections can be used to calculate the applied pressure. Moreover, a power electrical connection 1310e can extend from the amplifier 1307 to both sensors 1152, 1154 to power the sensors, and a ground electrical connection 1310f can extend from the amplifier 1307 to both sensors 1152, 1154 to ground the sensors.

Referring to FIGS. 9A and 9B, the pump module 1100 and the control module 1200 can be configured to connect together mechanically so as to ensure that the required electrical connections are made. Thus, pump module 1100 can include a pump connector 1192, and the control module 1200 can include a module connector 1292 that attaches to or interlocks with the pump connector 1192. The mechanical connection between the pump module 1100 and control module 1200 can be, for example, a spring and lever lock, a spring and pin lock, a threaded connector such as a screw.

The connectors 1192 can provide not only the mechanical connections between the pump module 1100 and control module 1200, but also the required electrical connections. For example, as shown in FIG. 10, a nine-pin connector 1500 can be used to provide the required mechanical and electrical connections 1310a-1310h. Other acceptable connectors with minimum of 8 connections are molex, card edge, circular, mini sub-d, contact, or terminal block.

The electrical and mechanical connections between the pump module 1100 and the control module 1200 are configured to function properly regardless of the type of pump module 1100 used. Accordingly, the same control module 1200 can be consecutively connected to different pump modules 1100. For example, the control module 1200 could be attached to a first pump module that produces a first flow rate range, such as a flow rate range 0.1-5 ml/hr. The control module 1200 could then be disconnected from the first pump module and attached to a second pump module that runs at the same flow rate range or at a second, different flow rate range, such as 1 ml-15 ml/hr. Allowing the control module 1200 to be connected to more than one pump allows the pump modules to be packaged and sold separately from the control module, resulting in lower-priced and lower-weight pump systems than are currently available. Moreover, using a single control module 1200 repeatedly allows the user to become more familiar with the system, thereby reducing the amount of human error incurred when using a pump system. Further, having a separate control module and pump module can advantageously allow, for example, for each hospital room to have a single controller than can be connected to any pump required for any patient.

Moreover, because the control module 1200 and the pump modules can be individually packaged and sold, the pump module can be pre-primed with a delivery fluid, such as a drug. Thus, the reservoir 1342 and the fluid paths can be filled with a delivery fluid prior to attachment to a control module 1200. When the pump module 1100 is pre-primed, substantially all of the air has been removed from the reservoir and fluid paths. The pump module 1100 can be pre-primed, for example, by the pump manufacturer, by a delivery fluid company, such as a pharmaceutical company, or by a pharmacist. Advantageously, by having a pre-primed pump module 1100, the nurse or person delivering the fluid to the patient does not have to fill the pump prior to use. Such avoidance can save time and provide an increased safety check on drug delivery.

Further, referring to FIG. 11, the pump module 1100 can include a module identifier 1772. The module identifier 1772 can be, for example, a separate microprocessor, a set of resistors, an RFID tag, a ROM, a NandFlash, or a battery static RAM. The module identifier 1772 can store information regarding, for example, the type of delivery fluid in the pump module, the total amount of delivery fluid in the pump module, the pump module's configured range of flow rates, patient information, calibration factors for the pump, the required operation voltage for the pump, prescription, bolus rate, basal rate, bolus volume, or bolus interval. The information stored in the module identifier 1772 can be programmed into the module identifier by the manufacturer, the fluid manufacturer, such as a pharmaceutical company, and/or the pharmacist.

Like the module identifier 1772, the microprocessor 1305, can store information regarding the type of delivery fluid in the pump module, the total amount of delivery fluid in the pump module, the pump module's configured range of flow rates, patient information, calibration factors for the pump, the required operation voltage for the pump, prescription, bolus rate, basal rate, bolus volume, or bolus interval. The information stored in the microprocessor can be programmed into the module identifier by the person delivering the fluid to the patient.

The module identifier and the microprocessor 1305 can be configured to communicate communication signals 1310i, 1310j. The signals 1310i, 1310j can be used to ensure that the pump module 1100 runs properly (e.g., runs with the correct programmed cycles). Despite the additional sensors in this embodiment, a simple mechanical and electrical connection can still be made between the pump module 1100 and the control module 1200, such as using a DB9, molex, card edge, circular, contact, mini sub-d, usb, or micro usb.

In some embodiments, the microprocessor 1305 includes the majority of the programmed information, and the module identifier 1772 includes only the minimum amount of information required to identify the pump, such as the type and amount of drug in the particular pump as well as the required voltage levels. In this instance, the microprocessor 1305 can detect the required delivery program to run the pump module 1100 properly. In other embodiments, the module identifier 1772 includes the majority of the programmed information, and the microprocessor 1305 includes only the minimum amount of information required to properly run the pump. In this instance, the control module 1200 is essentially instructed by the module identifier 1772 regarding the required delivery program. In still another embodiment, each of the microprocessor 1305 and the module identifier 1772 include some or all of the required information and can coordinate to run the pump properly.

The information stored in the module identifier 1772 and microprocessor 1305 can further be used to prevent the pump module from delivering the wrong fluid to a patient. For example, if both the pump module 1772 and the microprocessor 1305 were programmed with patient information or prescription information, and the two sets of information did not match, then the microprocessor 1305 can be configured to prohibit the pump module from delivering fluid. In such instances, an audible or visible alarm may be triggered to alert the user that the pump system has been configured improperly. Such a “handshake” feature advantageously provides an increased safety check on the delivery system.

Although the gel coupling is described herein as being used with an electrokinetic pump system, it could be used in a variety of pumping systems, including hydraulic pumps, osmotic pumps, or pneumatic pumps. Moreover, in some embodiments, a gel as described herein could be used in addition to a piston, i.e. between the piston and the membrane, to provide enhanced efficiency by allowing there to be less unsupported area of the membrane due to the compressibility of the gel, as described above.

Further, the modularity aspects of the systems described herein, such as having a separate pump module and control module need not be limited to EK systems nor to systems having a gel coupling. Rather, the modularity aspects could be applicable to a variety of pumping systems and/or to a variety of movable members, such as a mechanical piston, separating the engine from the pump.

As for additional details pertinent to the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.

It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

	Number	Date	Country
	61482889	May 2011	US
	61482918	May 2011	US

GEL COUPLING FOR ELECTROKINETIC DELIVERY SYSTEMS

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Provisional Applications (2)