Patent ID: 12214162

DETAILED DESCRIPTION

In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.

According to some embodiments, there is provided an infusion pump comprising: a plunger configured to squeeze a section of an infusion tube; a proximal valve (also referred to herein as the “upstream valve”) located proximally to the plunger; and a distal valve (also referred to herein as the “downstream valve”) located distally to the plunger, wherein the distal valve is configured to ascend and thereby allow infusion fluid flow past the distal valve and to descend and thereby inhibit infusion fluid flow past the distal valve; and a controller configured to control the plunger, the proximal valve and the distal valve and thereby to control infusion fluid delivery to a subject and infusion fluid intake from an infusion source. According to some embodiments, the infusion pump further comprises a pressure sensor. According to some embodiments, the controller is configured to control movement of the plunger based on pressure measurements obtained from the pressure sensor.

According to some embodiments, the controller is configured to initiate an initial descending of the plunger prior to the ascending of the distal valve so as to create a positive pressure prior to the distal valve opening (while the proximal valve is closed) to compensate immediately for negative fluid flow that would otherwise result from ascending of the distal valve. According to some embodiments, the controller is configured to initiate a partial initial ascending of the distal valve. According to some embodiments, a partial initial ascending of the distal valve may form a discrete fluid path opening in accordance with a set flow rate requirement. Advantageously such partial initial ascending of the distal valve may better couple the negative and positive infusion fluid flows and thus reduce boluses. According to some embodiments, the controller is configured to initiate a partial descending of the plunger concurrently with the continued ascending of the distal valve (while the proximal valve is closed). According to some embodiments, this partial descending of the plunger depends on pressure in the section of an infusion tube measured by the pressure sensor. According to some embodiments, the above described descending of the plunger before or concurrently with the ascending of the distal valve may be referred to herein as a “compensatory” descending of the plunger that compensates for vacuum produced by the ascending of the distal valve, thereby reducing backflow of fluid from the subject. According to some embodiments, the descending of the plunger required for delivering the infusion fluid may be initiated once the distal valve reaches its upper position. As used herein, including in the claims, the term “upper position” of the distal valves refers to the maximum upper position of the distal valve in any given pump cycle, i.e., the upper limit of the distal valve stroke in any given pump cycle. According to some embodiments, the descending of the plunger required for delivering the infusion fluid may be initiated concurrently with the continued ascending of the distal valve to its upper position. According to some embodiments, this distal valve upper position may be dictated by pressure in the section of an infusion tube as measured by the pressure sensor.

According to some embodiments, the compensatory descending of the plunger may be performed separately from the descending of the plunger required for delivering the infusion fluid. According to some embodiments, the compensatory descending rate of the plunger may be same or different than the descending rate of the plunger required for delivering the infusion fluid. According to some embodiments, the compensatory descending of the plunger may be less than the descending of the plunger required for delivering the infusion fluid. According to some embodiments, the compensatory descending of the plunger may be coextensive with (an integral part of) the descending of the plunger required for delivering the infusion fluid.

Typically, the descending of the plunger being either (a) the compensatory descending of the plunger or (b) the descending of the plunger required for delivering the infusion fluid, depends on the state of the distal valve. While the distal valve is occluding the tube, the descending of the plunger is compensatory and acts to increase pressure in the isolated segment of the tube i.e., between the proximal and distal valves, thereby preparing a bolus that compensates for the suction that occurs when the distal valve is opened. For some set flow rates (e.g., less than 300 mL/h), the rate of the compensatory descending of the plunger is typically higher than the rate of the descending of the plunger required for delivering the infusion fluid.

The compensatory descending of the plunger is typically dependent on a predetermined volume of the bolus that compensates for the suction due to the ascending of the distal valve, which relates to parameters of the distal valve, e.g., the geometry of the distal valve, the stroke of the distal valve, and/or the size of the distal valve. Typically, the volume of the bolus prepared during the compensatory descending of the plunger is independent of the “set flow rate” of the infusion fluid (i.e., the flow rate which is set by an operator or programmer of the infusion pump). Contrary to the compensatory descending of the plunger, the descending of the plunger required for delivering the infusion fluid depends on the set flow rate of the infusion fluid.

According to some embodiments, the volume of the prepared bolus during the compensatory descending of the plunger may be calculated and accounted for as a part of the total delivered volume of infusion fluid. According to some embodiments, the compensatory descending of the plunger may be calculated according to pressure in the section of the infusion tube between the proximal and distal valves.

As used herein, the term “compensation” with regards to the plunger refers to a movement of the plunger which counteracts, nullifies, reverses, evens out or otherwise inhibits an undesired flow of infusion fluid to the patient's vein or reverse fluid/blood flow from the patient, caused by movement of the distal valve.

According to some embodiments, the distal valve is configured to ascend from a lower position, at which fluid delivery to the patient is essentially blocked, to an upper position, at which fluid delivery to the patient is facilitated. According to some embodiments, the ascending of the distal valve to the upper position may be minor such that the opening of the tube for delivery remains narrow (e.g. up to 30% area of the inner cross section of the infusion tube). Advantageously, at both the upper position and the lower position, the distal valve at least partially squeezes a section of the infusion tube, thereby reducing the volume of backflow caused by the ascending of the distal valve as well as enhancing the compensation for vacuum produced by the ascending of the distal valve and reducing power consumption. Advantageously, the smaller descending range of the valve reduces the positive flow bolus size.

According to some embodiments, descending of the plunger required for delivering the infusion fluid may be a descending of the plunger from an upper squeezing position to a lower squeezing position, wherein at both the upper squeezing position and the lower squeezing position, the plunger is squeezing a section of an infusion tube, such that an opposite side of an inner surface of the section does not contact the squeezed side, thus ensuring that the delivery of the infusion fluid is at an essentially constant volume regardless of a potential degradation of the infusion tube as well as inhibiting or at least reducing tube degradation.

As used herein, the term “infusion fluid” may refer to any fluid delivered to the patient such as, but not limited to, insulin, nutrients, saline solution, antibiotics, analgesics, anesthetics, hormones, vasoactive drugs, and chelation drugs, and any other therapeutic fluids or combination of fluids.

As used herein, the term “upper squeezing position” with regards to the plunger, refers to a position of a plunger at which an infusion tube is mildly squeezed (i.e. lower than a position at which the tube is not squeezed), without having the opposite sides of an inner surface of the squeezed section contacting one another. According to some embodiments, the delivery phase of the infusion pump is initiated at the “upper squeezing position” or at “after compensation” position. According to some embodiments, the upper squeezing position is higher (less squeezing of the tube) than the position of the plunger when descended to compensate for the backflow caused by the ascending of the distal valve.

As used herein, the term “lower squeezing position” with regards to the plunger, refers to a position of the plunger at which an infusion tube is squeezed to a larger extent as compared to the upper squeezing position, yet still without having the opposite sides of an inner surface of the squeezed section contacting one another.

As used herein, the term “degradation” may refer to the tube losing its springiness, becoming deformed, bottoming out, or otherwise changing its shape or consistency in a manner affecting the drug delivery accuracy. According to some embodiments, the infusion tube may be a DEHP-free PVC infusion tube, a DEHP containing infusion tube, a polyethylene (PE) tube, a silicone tube, a polyurethane tube or the like. Each possibility is a separate embodiment.

According to some embodiments, the velocity of the ascending and descending of the distal valve and/or of the plunger depends on the set flow rate of the infusion fluid. According to some embodiments, the ascending and/or descending of the plunger may be continuous, i.e. at a constant rate. According to some embodiments, the ascending and/or descending of the plunger may be pulsatory, i.e. in small steps. According to some embodiments, the ascending and/or descending of the distal valve may be continuous, i.e. at a constant rate. According to some embodiments, the ascending and/or descending of the distal valve may be pulsatory, i.e. in small steps. That is, at high set flow rates, the velocity of the ascending and descending of the distal valve and/or of the plunger may likewise be high, and at low set flow rates, the velocity of the ascending and descending of the distal valve and/or of the plunger may likewise be low. According to some embodiments, the controller may be configured to automatically adjust the velocity of the ascending and descending of the distal valve and/or of the plunger according to the set flow rate. This ascending/descending sequence and control of movement allow continued fluid delivery flow. For example, the controller may adjust the rate of the descending of the distal valve based on the set flow rate in order to avoid a bolus delivery upon descending of the distal valve, i.e., the rate of the descending of the distal valve is controlled by the controller such that as the distal valve descends the distal valve pushes infusion fluid to the subject at the set flow rate. Thus, for higher flow rates, i.e., faster descending of the plunger, a faster descending of the distal valve may be set, and for lower flow rates, i.e., slower descending of the plunger, a slower descending of the distal valve may be set. The extra volume of fluid pushed to the subject during the descending of the distal valve may be calculated and accounted for as part of the volume of infusion fluid delivered per pump cycle.

Typically, the “upper position” of the distal valve refers to a position of the distal valve at which an infusion tube is squeezed (i.e. lower than a position at which the tube is not squeezed), without having the opposite sides of an inner surface of the squeezed section contacting one another. That is, at the upper position the distal valve engages the infusion tube.

As used herein, the term “lower position” with reference to the distal valve refers to a position of the distal valve at which the infusion tube is squeezed to such extent that delivery of infusion fluid to the patient is essentially avoided.

According to some embodiments, the inner tube cross section of the infusion tube when the distal valve is in its upper position is 30%-98% (e.g., a preset value, e.g., 50%) of the area of the inner tube cross section of the infusion tube, when non-squeezed. Various upper positions for the distal valve may be used, affecting the percentage of the squeezed area, for different set flow rates. For example, while in its upper position the distal valve still squeezes the infusion tube in order to reduce the bolus that is caused by the descending of the distal valve. Nevertheless, while in its upper position the distal valve should be open enough so as not to inhibit delivery of the infusion fluid during the descending of the plunger.

According to some embodiments, for a typical tube of 3 mm inner diameter and a wall thickness of 0.5 mm, a typical upper position, of the distal valve is about 0.3 mm to 2.8 mm, lower than the diameter of a non-squeezed tube. Each possibility is a separate embodiment.

According to some embodiments, the infusion pump is configured to maintain an essentially constant flow rate during the entire delivery of an infusion fluid. As a non-limiting example, the infusion pump is configured to maintain a delivery of an infusion fluid at a set flow rate of 1±0.05 mL/hour for at least 20, at least 36 or at least 96 hours.

According to some embodiments, the pump further includes a motor in communication with the controller, the motor configured to operate the plunger. According to some embodiments, the motor may further be configured to operate the proximal valve, the distal valve or both. Alternatively, the pump may include one or two additional motors configured to operate the proximal valve, the distal valve or both. According to some embodiments, the controller may control the operation of the motor, thereby determining the exact position of the plunger and/or the distal valve. According to some embodiments, the controller may control the operation of the motor, by determining a velocity/rate of the ascending/descending of the plunger, the proximal valve and/or the distal valve. According to some embodiments, the controller may control the operation of the motor, by determining the increments of the ascending/descending of the plunger, the proximal valve and/or the distal valve. According to some embodiments, the controller may control the operation of the motor, by determining the value of the ascending/descending of the plunger, the proximal valve and/or the distal valve.

According to some embodiments, the controller may further be configured to determine a “wait” period, during which the plunger remains at the upper squeezing position, thereby ensuring full engagement of the infusion tube with the plunger, prior to the closing of the infusion pump's upstream valve. This advantageously increases the accuracy of infusion fluid delivery in that the volume delivered remains constant even if the infusion tube has undergone degradation.

Furthermore, due to the infusion tube fully engaging the plunger, a persistent ascending of the infusion tube after opening of the upstream valve is essentially inhibited. The length of the wait depends on the flow continuity requirements and the set flow rate. For low set flow rates (0.1-1 mL/hr) and flow continuity of bolus every 20 sec, the wait can last up to 18 sec. For higher set flow rates, the wait time can be shorter (e.g. about 10 sec) and for very high flow rates (999 mL/hr) it may last less than 1 second. The long wait is particularly advantageous for low set flow rates where the tube squeeze duty cycle is very long. The long wait times are essentially a no movement of plunger and valves in the specific position while for high set flow rates the “wait” equals pump's check-in time—the time the pump goes through the encoders that leave the plunger in the upper position while the proximal valve is open.

According to some embodiments, there is provided a method of operation of an infusion pump, the method comprising utilizing the infusion pump, as essentially described herein.

Reference is now made toFIG.1which schematically illustrates an infusion pump100with a plunger110, a proximal/upstream valve120, also referred to herein as an inlet valve, positioned proximally/upstream to plunger110and configured to allow flow of infusion fluid from a reservoir (not shown) to an infusion tube150and a distal/downstream valve125, also referred to herein as an outlet valve, positioned distally/downstream to plunger110and configured to allow flow of infusion fluid from infusion tube150to a patient (not shown). The positioning of plunger110, proximal valve120and distal valve125are carried out by motor140and associated cam shaft142, although other embodiments, according to which positioning of plunger110, proximal valve120and distal valve125is executed by separate motors, are also possible and within the scope of this disclosure. Motor140is typically controlled by a controller141. Infusion pump100further includes a force sensor160configured to measure the pressure in the part of infusion tube150extending between proximal valve120and distal valve125. The figure illustrates the pump at a state when proximal valve120is at a tube releasing position, distal valve125is at a tube occluding position and plunger110is at a tube squeezing position.

Reference is now made toFIGS.2A-Bwhich are, combined, an illustrative flowchart200for operating an infusion pump, according to some embodiments.

In step210an infusion tube is positioned within an infusion pump, the infusion pump comprising a plunger, a proximal valve located proximally to the plunger, and a distal valve located distally to the plunger.

Steps220to240are steps associated with intake of infusion fluid from a reservoir (also referred to herein as infusion source).

In step220an opening of the proximal valve is initiated (while the distal valve is closed), thereby establishing a fluid flow connection between the reservoir and the infusion tube.

In step230the plunger is caused to ascend, thereby causing intake of fluid from a reservoir. The ascending of the plunger, causing intake of the infusion fluid from the reservoir, is only initiated once the distal valve has reached its lower position at which the fluid flow connection between the infusion tube and the patient's vein has been closed.

In step240descending of the proximal valve is initiated to occlude the fluid line to terminate the fluid intake. The occlusion of the fluid line by proximal valve is completed before the distal valve starts ascending, thereby providing a phase where both valves are closed, during which the compensation step is carried out.

Steps250to280are steps associated with delivery of the infusion fluid to a patient.

In step250a partial, compensatory descending of the plunger is initiated prior to or concurrently with an initial ascending of the distal valve, thereby generating a positive pressure in the tube. Typically, up to 30% of the area of the inner tube cross section of the infusion tube is opened during the initial ascending motion of the distal valve. The compensatory descending of the plunger is configured to ensure that backflow of blood from the patient's vein into the infusion tube, as a result of the ascending of the distal valve, is reduced or inhibited. It is understood that the method alternatively may include two separate steps; a first step (e.g. step250a) of partial compensatory descending of the plunger prior to the initial ascending of the distal valve and a second step (e.g. step250b) of additional compensatory descending of the plunger concurrently with the ascending of the distal valve. During this step (250or250b), the pressure in the infusion tube between the valves is measured by the force sensor. If a decrease in pressure is observed, indicating that the distal valve has opened and downstream flow of infusion fluid is facilitated, the plunger transitions to descending at a rate corresponding to the set flow rate of the infusion fluid. It is noted that in the illustrative figure of step250the plunger and the distal valve appear to be in the same position as they are in the illustrative figure of step240. The partial compensatory descending of the plunger is small and therefore not noticeably shown in the figure. Additionally, the distal valve is shown closed, since the partial compensatory descending of the plunger may occur prior to the initial ascending of the distal valve.

In step260the ascending of the distal valve and the descending of the plunger is continued. According to some embodiments, the rate of the ascending of the distal valve increases with the set flow rate, e.g., for higher set flow rates the distal valve ascends at a higher rate.

Optionally, in step270the plunger is further lowered thereby causing the infusion fluid to be delivered to the patient. Alternatively, the continuous ascending of the distal valve in step260may be very slow and prolonged, such that the delivery of the infusion fluid becomes an integral part of step260.

In step280, upon the plunger having completed the squeezing of the infusion tube, a descending of the distal valve is initiated to occlude the infusion line. The volume delivered due to descending of the distal valve may be determined and taken into account as part of the total volume of infusion fluid delivered, as described hereinabove. The rate of the descending of the distal valve may be adjusted to match the set flow rate of delivery.

It is understood that upon completion of infusion fluid delivery, additional intake/delivery cycles may be performed by repeating steps220through280.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, or components, but do not preclude or rule out the presence or addition of one or more other features, steps, operations, elements, components, or groups thereof.

Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilizing terms such as “processing”, “computing”, “calculating”, “determining”, “estimating”, or the like, refer to the action and/or processes of a computer or computing system (e.g., controller141), or similar electronic computing device, that manipulate and/or transform data represented as physical, such as electronic, quantities within the computing system's registers and/or memories into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices.

Embodiments of the present invention may include apparatus for performing the operations herein. This apparatus may be specially constructed for the desired purposes, or it may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of Non-volatile memory (NVM), or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus.

The processes and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the desired method. The desired structure for a variety of these systems will appear from the description below. In addition, embodiments of the present invention are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of some of the inventions as described herein.

Embodiments of the invention may be described in the general context of computer-executable instructions, such as program modules, being executed by a computer. Generally, program modules include routines, programs, objects, components, data structures, and so forth, which perform particular tasks or implement particular abstract data types. Embodiments of the invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote computer storage media including memory storage devices.

While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, additions and sub-combinations as are within their true spirit and scope.