Infusion pump flow control

Abstract

To provide a disposable pump capable of providing a fluid medicament to a user at an accurate and constant flow rate.SOLUTION: In accordance with the present invention, an infusion pump includes a housing having an elastic component configured to expand and store potential energy, and a first tube fluidly coupled to an outlet of the housing. The first tube is configured to direct fluid from the housing at a first flow rate. The infusion pump further includes an air filter fluidly coupled to the distal end of the first tube via an air filter inlet, and a second tube fluidly coupled to the air filter via an air filter outlet. The second tube is configured to regulate a first flow rate of the fluid directed from the housing to a second flow rate. The infusion pump further includes one or more components for dispensing fluid to a user, wherein the one or more components are fluidly coupled to the outlet of the second tube.SELECTED DRAWING: Figure 4B

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 030,232, filed May 26, 2020, and entitled "INFUSION PUMP FLOW RATE CONTROL," which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to fluid pumps, and more particularly to portable infusion pumps useful for pumping relatively small volumes of fluid at a precise and consistent flow rate under substantially constant pressure for sustained periods of time. The present invention is particularly, but not exclusively, useful for single-use use as a disposable pump for infusing fluid medications into ambulatory patients. [Background technology]

[0003] Disposable pumps (also known as elastomeric pumps, ambulatory pumps, or CADD pumps) have been around for some time. These disposable pumps offer clear low-cost care benefits and are used in a variety of applications, from antibiotic administration to pain management to chemotherapy administration. Alternate site care (e.g., at home or in large cancer hospitals) is also becoming increasingly common. Given the rising cost of healthcare, more gentle options are needed. Disposable pumps can offer users a cost-effective way to meet their healthcare needs. However, current disposable pumps do not always provide users with accurate and consistent flow rates for infusing fluid medications. Summary of the Invention

[0004]

[0004] Accordingly, those skilled in the art have recognized a need for a disposable pump that can provide a user with a fluid medication at an accurate and consistent flow rate. Additionally, a need has been identified for a flow restrictor that can be more cost-effectively manufactured and that allows for the use of interchangeable parts with various size restrictors. The present invention fulfills these and other needs.

[0005] In some embodiments, an infusion pump includes a housing. The housing includes an elastic component configured to expand and store potential energy generated by fluid within the infusion pump. The infusion pump includes a first tube fluidly coupled to an outlet of the housing. The first tube is configured to direct fluid from the housing at a first flow rate based in part on the potential energy stored by the elastic component. The infusion pump includes an air filter fluidly coupled to a distal end of the first tube via an air filter inlet. The air filter is configured to vent air from the fluid substantially upstream through one or more air holes such that the fluid exiting the air filter is primed and air-free. The infusion pump includes a second tube fluidly coupled to the air filter via an air filter outlet, the second tube configured to adjust the first flow rate of fluid directed from the housing through the first tube to a second flow rate. The second flow rate is based at least in part on an inner diameter of the second tab. The infusion pump further includes a second tube outlet fluidly coupled to one or more components for dispensing fluid to a user.

[0006] In some embodiments, a method of infusing a fluid into a patient is performed in an infusion pump that includes a housing including a resilient component, a first tube fluidly coupled to the housing through an outlet of the housing, an air filter fluidly coupled to a distal end of the first tube through an air filter inlet, a second tube fluidly coupled to the air filter through an air filter outlet, and an outlet of the second tube fluidly coupled to one or more components. In some embodiments, a method performed in an infusion pump includes expanding an elastic component with fluid to store potential energy generated by the fluid in the infusion pump; directing fluid from the housing through a first tube at a first flow rate based in part on the potential energy stored by the elastic component; venting air from the fluid through one or more air holes in an air filter, the air being vented substantially upstream so that the fluid exiting the air filter is primed and air-free; adjusting the first flow rate of the fluid directed from the housing through the first tube to a second flow rate, the second flow rate based at least in part on an inner diameter of the second tube; and dispensing fluid to a user through one or more components coupled to an outlet of the second tube.

[0007] For a better understanding of the various embodiments described, reference should be made to the following description of the embodiments in conjunction with the following drawings, in which like reference numerals indicate corresponding parts throughout the figures and description. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a diagram of a disposable infusion pump according to some embodiments. [Figure 2] 1 is a diagram of a disposable infusion pump according to some embodiments. [Figure 3] 1 is a schematic diagram of a disposable pump system according to some embodiments. [Figure 4A]1 is a cross-sectional view of a disposable pump according to some embodiments. [Figure 4B] 1 is a cross-sectional view of a disposable pump according to some embodiments. [Figure 5A] FIG. 1 is a diagram of a flow restrictor component according to some embodiments. [Figure 5B] FIG. 1 is a diagram of a flow restrictor component according to some embodiments. [Figure 6A] FIG. 10 is a diagram of another flow restrictor component according to some embodiments. [Figure 6B] FIG. 10 is a diagram of another flow restrictor component according to some embodiments. [Figure 7] FIG. 1 is a block diagram illustrating a flow control device according to some embodiments. [Figure 8A] 1 is a flow chart illustrating a method for controlling the flow rate of a disposable pump according to some embodiments. [Figure 8B] 1 is a flow chart illustrating a method for controlling the flow rate of a disposable pump according to some embodiments. [Figure 8C] 1 is a flow chart illustrating a method for controlling the flow rate of a disposable pump according to some embodiments. [Figure 8D] 1 is a flow chart illustrating a method for controlling the flow rate of a disposable pump according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0009] Embodiments disclosed herein include an infusion pump and infusion method for infusing a fluid medication into a user. The infusion pump is coupled to a user and configured to provide the fluid medication to the user at a precise and consistent flow rate. Accordingly, the embodiments disclosed herein provide various devices and / or techniques for controlling and / or regulating the flow rate of the fluid medication. Furthermore, by providing the fluid medication to a user at a precise and consistent flow rate that can be controlled, the infusion pump and infusion method disclosed herein facilitate the safe infusion of the fluid medication.

[0010] Some additional advantages of embodiments consistent with the present disclosure include precise control of flow rate and lower achievable flow rates for fluid medications dispensed to a user. Specifically, infusion pumps can be designed to provide a desired flow rate and, if necessary, the flow rate can be finely adjusted on demand. Furthermore, infusion pumps and infusion methods allow for great flexibility in achieving various flow rates by using one or more of the techniques and / or devices disclosed herein. The embodiments disclosed herein are suitable for a variety of fluid medications and / or applications (e.g., chemotherapy administration, antibiotic administration, pain management, etc.). Thus, increasing the flexibility in adjusting flow rate and / or increasing the number of applications for an infusible pump reduces overall costs by providing an affordable alternative for fluid medication infusion that is functional across a variety of applications.

[0011] FIG. 1 illustrates a disposable infusion pump according to some embodiments. As shown in FIG. 1, the disposable pump 100 (also referred to herein as an infusion pump) can be worn by an ambulatory user 102 and attached to the user 102 by a holder 104. The holder 104 can be a belt, fanny pack, lanyard, backpack, pouch, and / or other device for carrying the disposable pump 100. Additionally, FIG. 1 illustrates that the disposable infusion pump 100 can be fluidly coupled to the user 102 for infusion of a fluid into the user 102 through a first medical tubing 106. In some embodiments, the fluid can be water or any fluid medication, such as a chemotherapy drug, pain medication, prescription medication, saline, etc. The first medical tubing 106 may be any type of IV tubing for intravenous drip, such as air filtered micro-bore IV tubing, small bore IV tubing, large bore IV tubing, and / or any other type of tubing for intravenous drip.

[0012] In some embodiments, the material for the first medical tubing 106 is Tygon®, thermoplastic elastomer (TPE), polyethylene, polyvinyl chloride (PVC), nylon, silicone, and / or other similar materials. The Tygon material adheres to various components of the infusion pump using a single solvent application. The Tygon material may offer advantages in that it can be extruded at a much smaller inner diameter than other types of tubing on the pump (e.g., PVC), increasing flow rate accuracy and making the tubing less sensitive to length adjustments. Furthermore, small changes in diameter accuracy can have an exponential effect on flow rate accuracy.

[0013] In some embodiments, an in-line air filter 108 is fluidly coupled to the first medical tubing 106 (via an inlet of the in-line air filter 108). The in-line air filter 108 may be a pediatric IV filter, a micro IV filter, and / or other suitable filter for drug delivery, chemotherapy, insulin infusion, antibiotic therapy, Lipid / TPN infusion, neonatal infusion therapy, etc. The in-line air filter 108 is configured to remove air from the channeled fluid (e.g., away from the disposable pump 100) to prevent infusion of air into the user 102. In some embodiments, the in-line air filter 108 is configured to remove contaminants and / or particles from the fluid to prevent infusion of harmful substances into the user 102. In some embodiments, the air filter is positioned near the disposable pump 100 (as described below) so that air is exhausted from the fluid substantially upstream and the fluid exiting the air filter is primed (air-free) for infusion of the user 102. Primed, in some embodiments, means filling the medical tubing 106 with fluid so that the fluid is ready to be injected into the user 102 .

[0014] In some embodiments, second medical tubing 112 is fluidly coupled to in-line air filter 108 (via the outlet of in-line air filter 108). In some embodiments, first medical tubing 106 and second medical tubing 112 are the same (e.g., tubing of the same type (e.g., material), tubing of the same size (e.g., inner and outer diameter), tubing of the same length, etc.). In some other embodiments, first medical tubing 106 and second medical tubing 112 are different (e.g., including one or more variations in tubing type, tubing size (e.g., inner and / or outer diameter), tubing length, etc.). First medical tubing 106 and second medical tubing 112 are discussed in further detail below with reference to FIGS. 4A-4B.

[0015] Additionally or alternatively, in some embodiments, an external flow restrictor 110 is coupled to the first medical tubing 106 (e.g., via an exterior portion of the first medical tubing 106) to provide and / or remove external pressure from the first medical tubing 106. The external pressure on the first medical tubing 106 is configured to open or close a fluid passageway in the first medical tubing 106 (e.g., stop or start fluid flow from the pump 100 by applying sufficient pressure to the first medical tubing 106 to act as a shut-off valve). The external flow restrictor 110 may be a slide clamp, a pinch clamp, a roller clamp, a screw clamp, and / or any other type of device capable of starting or stopping fluid flow from the disposable pump 100.

[0016] FIG. 2 shows a schematic diagram of a disposable infusion pump 100 according to some embodiments. In some embodiments, the disposable pump 100 includes a housing 200 that is an assembly of a first portion 202 and a second portion 204. In some embodiments, the first portion 202 includes a first surface 402a (e.g., an exterior or top surface, as shown in FIG. 4 ) and a second surface 402b (e.g., an interior or bottom surface, as shown in FIG. 4 , when the first and second portions 202 and 204 are coupled) that is directly opposite the first surface. In some embodiments, the first surface of the first portion 202 includes an inlet 208 for receiving a fluid and an outlet 210 for dispensing a fluid. In some embodiments, the second surface includes a resilient element 206 coupled between a first ring 410 and a second ring 414 (as shown in FIG. 4 ). The first and second rings are affixed to the second surface. Specifically, in some embodiments, the first ring is affixed to the second surface via edge 404 of the first portion (as shown, for example, in FIG. 4). The elastic component 206 is configured to expand and store potential energy generated by fluid within the infusion pump, as discussed below. As further shown in FIG. 2, in some embodiments, the first medical tubing 106 is coupled to an outlet 210 (on the first surface) of the first portion 202 so that fluid can be dispensed from the disposable pump 100 (when loaded with fluid, as described below with reference to FIG. 4).

[0017] FIG. 3 is a schematic diagram of a pump system according to some embodiments. In some embodiments, the first portion 202 (including the first surface 402a and the second surface 402b shown in FIG. 4) of the housing 200 is made of a hard plastic, such as polycarbonate, and / or other material that is chemically compatible with the fluid to be infused into the user 102. In some embodiments, the first portion 202 has a parabolic shape (or a dome / diaphragm shape) with the second surface 402b extending in the opposite direction from the first surface 402a (e.g., the first surface is slightly convoluted). In some embodiments, the first portion 202 is configured to stretch the elastic component 206 (via the second surface 402b) into a similar shape when assembled (e.g., as shown in FIGS. 4A and 4B). In some embodiments, the second surface 402b of the first portion 202 defines the shape of the elastic component 206 (e.g., when storing potential energy or not). In some embodiments, the edge 404 of the first portion 202 extends outward from the second surface 402b to provide a surface for coupling the resilient component 206 onto the first portion 202 (e.g., via an upper ring 410 and a lower ring 414, as described below). As will be appreciated by those skilled in the art, the first portion 202 of the housing 200 may be manufactured using injection molding, urethane casting, 3D molding, and / or other manufacturing procedures.

[0018] In some embodiments, a valve sleeve 406 and valve insert 408 are inserted into the inlet 208 (e.g., the valve sleeve 406 and valve insert 408 shown in FIG. 4). When inserted into the inlet 208, the sleeve 406 and valve insert 408 create a one-way valve for the first portion 202 of the housing 200, allowing fluid flow in one direction (e.g., from the outside through the inlet 208). One important aspect of the disposable pump 100 is the ability to fill the disposable pump 100 with fluid through the inlet 208 and ensure that the fluid cannot leave the disposable pump 100 (e.g., exit the inlet 208 and / or other portions of the housing 200). In some embodiments, the fluid is loaded into the inlet 208 under pressure using a syringe (not shown) or other device for injecting fluid.

[0019] In some embodiments, the disposable pump 100 includes at least two retaining rings (e.g., an upper ring 410 and a lower ring 414). In some embodiments, the upper ring 410 is engaged with ribs 412 (e.g., ribs 412 shown in FIG. 4) that define the elastic component 206. In some embodiments, the upper ring 410 is also configured to engage with the lower ring 414 to effectively couple the ribs 412 of the elastic component 206 between the upper ring 410 and the lower ring 414. The upper ring 410 and the lower ring 414 may be of any suitable rigid material, such as polycarbonate. When joined together, the upper ring 410 and the lower ring 414 support the elastic component 206 and provide a solid foundation for the elastic component 206 to expand and store potential energy, as described below with respect to FIGS. 4A and 4B.

[0020] In some embodiments, the elastic component 206 is substantially circular and planar when unexpanded (e.g., in a relaxed and / or unstretched state). As described above, the ribs 412 define the shape of the elastic component 206 (e.g., in a relaxed or pressurized state) and are configured to be coupled between the upper ring 410 and the lower ring 414. Traditionally, the elastic component 206 is composed of multiple layers of elastomeric material, with at least one of the multiple layers acting as a drug barrier. The multiple layers of the elastic component 206 are used to retain a fluid medicament. A drug barrier is a layer that protects the fluid (retained by the multiple layers of the elastic component 206) from contamination from other layers of the multiple layers. However, a drug barrier does not always prevent chemical leaching due to the materials of other layers of the multiple layers. Chemical leaching is the migration of contaminants and / or other water-soluble particles into the fluid medicament. Elastomeric materials include natural rubber, isoprene, silicone, and / or other materials with high elastic recovery (e.g., materials that are capable of expanding and are configured to naturally or automatically return to their relaxed state).

[0021] To address the issue of seepage, in some embodiments, elastic component 206 is constructed of a single layer. In some embodiments, the single layer is liquid injection molded silicone. In some embodiments, the elastomeric material of elastic component 206 is of uniform thickness. In some embodiments, the elastomeric material of elastic component 206 can include a varying thickness across elastic component 206 (so long as elastic component 206 can expand and store potential energy). The varying thickness can strengthen portions of elastic component 206 that experience greater loads (e.g., greater loads on the edges of elastic component 206 near ribs 412 when fluid is loaded into disposable pump 100).

[0022] In some embodiments, the disposable pump 100 includes a second portion 204 of the housing 200. The second portion 204 may be a jar, bottle, and / or any other container shaped with an opening for receiving the first portion 202 of the housing 200, including the resilient component 206. In some embodiments, the second portion 204 is made of a rigid or semi-rigid plastic, such as PETG, which may be manufactured by processes such as blow molding and / or similar processes. In some other embodiments, the second portion 204 is made of glass. The resilient component 206 and the disposable pump 100 may be of various sizes, and the second portion 204 may be sized accordingly. For example, the second portion 204 may have an opening 416 large enough to accommodate the resilient component 206 and / or other components described herein, such as at least two retaining rings. Similarly, the second portion 204 is configured to contain (e.g., surround) the resilient component 206 when fully expanded. In some other embodiments, the size for second portion 204 may be made to accommodate a maximum fluid capacity proposal for disposable pump 100 (discussed below).

[0023] In some embodiments, a fluid (e.g., a fluid medication) loaded into the disposable pump 100 via the inlet 208 is configured to be delivered through the first medical tubing 106 from the outlet 210. The first medical tubing 106 conducts the fluid from the housing 200 at a first flow rate. The first flow rate is based, at least in part, on potential energy stored by the elastic component 206 when the elastic component 206 expands with fluid loaded into the inlet 208 (e.g., via a syringe or other similar device). In some embodiments, the first flow rate is based on the inner diameter of the first medical tubing 106, the length of the first medical tubing 106, and / or other factors (e.g., fluid viscosity, temperature, pressure changes, etc.). In some embodiments, the first flow rate is set to quickly prime the drip system for delivery of the fluid to the user 102. In some embodiments, the first flow rate is selected based on the second flow rate (discussed below) to account for an increase in the total time required to prime the disposable pump 100. In other words, the first flow rate may be set to quickly prime the disposable pump 100, while the second flow rate is configured to provide the fluid medicament to the user 102 at an appropriate (e.g., selected) flow rate. In some embodiments, the first flow rate is 167 mL / hr (+ / - 0.25 mL / hr) or less. In some embodiments, the first flow rate is between 5 mL / hr and 167 mL / hr. In some other embodiments, finer control of the first flow rate is achievable, achieving flow rates less than 5 mL / hr (e.g., a flow rate of about 2 mL / hr + / - 0.25 mL / hr). In some embodiments, control of the first flow rate may be achieved by adjusting the diameter and / or length of the first medical tubing 106. Various methods of controlling flow rates are discussed below.

[0024] In some embodiments, an external flow restrictor 110 is coupled to an exterior portion of the first medical tubing 106. The external flow restrictor 110 is configured to apply or remove external pressure to the first medical tubing 106, which closes or opens the fluid passageway of the first medical tubing 106, respectively. In other words, in some embodiments, the external flow restrictor 110 blocks the flow of fluid medicament leaving the housing 200 (e.g., fluid leaving via the outlet 210). In some embodiments, the external flow restrictor 110 blocks the fluid passageway of the first medical tubing 106 such that fluid injected via the inlet 208 expands the elastic component 206 (e.g., the disposable pump 100 can be primed without dispensing fluid before sufficient potential energy is stored). In some embodiments, the elastic component 206, upon expansion, stores potential energy that is used to create a pressure differential for infusing the user 102. Therefore, an external flow restrictor 110 or similar device is needed to create sufficient potential energy to ensure that the disposable pump 100 creates a substantially constant fluid pumping pressure as the elastic component 206 contracts from an expanded state to a relaxed state. It should be noted that the fluid injected into the disposable pump 100 via the inlet 208 needs to be charged with sufficient energy to overcome the resistance of the elastic component 206. In some embodiments, a medical syringe and / or any other tool for injecting fluids may be used to overcome the resistance of the elastic component 206. More information regarding the elastic component 206 is discussed below in FIGS. 4A and 4B.

[0025] In some embodiments, an in-line air filter 108 is included in the infusion system. In some embodiments, the air filter 108 is fluidly coupled to the distal end of the first medical tubing 106 (e.g., the end of the first medical tubing 106 opposite the outlet 210) via an air filter inlet. The air filter 108 is positioned substantially upstream near the outlet 210. In some embodiments, the air filter 108 is configured to exhaust air from the fluid through one or more air holes. The air is exhausted substantially upstream such that the fluid exiting the air filter 108 is primed and air-free. In some embodiments, the air filter 108 includes a membrane filter configured to remove one or more types of contaminants and particles from the fluid.

[0026] In some embodiments, second medical tubing 112 is fluidly coupled to air filter 108 via the air filter outlet. Second medical tubing 112 is configured to regulate a first flow rate of fluid channeled from housing 200 through first medical tubing 106 to a second flow rate. The second flow rate is based, at least in part, on the inner diameter of second medical tubing 112. In some other embodiments, the second flow rate is based on the length of first medical tubing 106 and / or other factors (e.g., fluid viscosity, temperature, pressure changes, etc.). In some embodiments, the first flow rate and the second flow rate are selected to rapidly prime disposable pump 100. For example, the first flow rate can be selected to be significantly higher than the second flow rate such that the disposable device is substantially primed, leaving only a smaller portion of the disposable pump 100 to be primed (e.g., the first flow rate can prime three-quarters of the disposable pump 100 (e.g., the length of the first medical tubing 106 and air filter 108), leaving only one-quarter (e.g., the length of the second medical tubing 112) to be primed at the second flow rate). In some embodiments, the second flow rate is 5 mL / hr or less. In some embodiments, the second flow rate is between 2 mL / hr and 5 mL / hr. In some other embodiments, the second flow rate is about 2 mL / hr (e.g., about + / - 0.25 mL / hr). In some embodiments, finer control of the second flow rate (e.g., less than 2 mL / hr) can be achieved by adjusting the diameter and / or length of the second medical tubing 112. In some embodiments, the inner diameter of the second medical tubing 112 is 0.0075 inches (0.1905 mm) or less. In some embodiments, the second medical tubing 112 is a predetermined length that depends on the targeted flow rate (e.g., a longer length results in a slower flow rate). In some examples, the second medical tubing 112 is used to adjust the flow rate of the fluid medication before it is dispensed to the user 102.

[0027] 1, the inner diameter of the first medical tubing 106 and the inner diameter of the second medical tubing 112 may be the same or different. Similarly, in some embodiments, the length, material, and / or other parameters of the first medical tubing 106 and the second medical tubing 112 may be the same or different. The parameters of the first medical tubing 106 and the second medical tubing 112 depend on the flow rate required to infuse the user 102. The second medical tubing 112 is used to achieve the desired flow rate before the fluid is infused into the user 102.

[0028] In some embodiments, the outlet 302 (e.g., a distal outlet) of the second medical tubing 112 is fluidly coupled to the second medical tubing 112. The outlet 302 of the second medical tubing 112 is configured to connect with one or more components for dispensing fluid to the user 102. In some embodiments, the outlet 302 of the second medical tubing 112 is a fixed male luer. In some embodiments, the one or more components configured to connect with the outlet 302 of the second medical tubing 112 include a skin patch, a needle, a cannula, and a catheter, and / or other components for infusing the user 102.

[0029] In some embodiments, a flow restrictor component is disposed within the first medical tubing 106 and / or the second medical tubing 112. For example, the flow restrictor component may be disposed at a first position 304a within the first medical tubing 106 and / or a second position 304b within the second medical tubing 112. In some embodiments, a flow restrictor may be disposed at each position (e.g., first position 304a and second position 304b). The flow restrictor component may be disposed at any position within the first medical tubing 106 and / or the second medical tubing 112. For example, the flow restrictor component may be disposed (e.g., within the first medical tubing 106) adjacent to the outlet 210 of the housing 200, adjacent to the outlet 302 of the second medical tubing 112, adjacent to the inlet or outlet of the air filter 108, and / or anywhere in between. In some embodiments, the flow restrictor component is not fixed and is configured to move freely along the first medical tubing 106 and / or the second medical tubing 112. Alternatively, or in addition, in some embodiments, the flow restrictor component is fixed (anchored or anchored) to a particular location on the first medical tubing 106 and / or the second medical tubing 112 (e.g., so that the flow restrictor component does not move).

[0030] The flow restrictor component is independent of the flow control provided by the first medical tubing 106 and / or the second medical tubing 112. In some embodiments, the flow restrictor component comprises one or more pins and / or beads, as described below in FIGS. 5A-6B. The flow restrictor component has a diameter less than the inner diameter of the first medical tubing 106 and / or the second medical tubing 112. In some embodiments, the flow restrictor component has a diameter larger than the inlet and / or outlet of the air filter 108 so that the flow restrictor component remains within a particular location or portion of the tubing (e.g., within the first medical tubing 106 or the second medical tubing 112). In some embodiments, the flow restrictor component has a diameter larger than the outlet 302 of the second medical tubing 112 so that the flow restrictor component does not flow into the user 102. Additionally, the flow restrictor component is configured to not break or shatter when a user moves the first medical tubing 106 and / or the second medical tubing 112. The flow restrictor component is discussed in more detail in Figures 5 and 6.

[0031] In some embodiments, the disposable pump 100 includes a controller chip (not shown) configured to operate valves to control the first flow rate and / or the second flow rate of the fluid. The controller chip is discussed below in FIG. 7. In some embodiments, the controller chip is a separate component fluidly coupled in series with one or more components of the disposable pump 100. For example, the controller chip may be fluidly coupled between the outlet 210 of the disposable pump 100 and the first medical tubing 106, between the first medical tubing 106 and the air filter 108, between the air filter 108 and the second medical tubing 112, and / or between the second medical tubing 112 and the outlet 302 of the second medical tubing 112. Alternatively, or in addition, in some embodiments, the controller chip is coupled to the housing 200. The flow controller chip is discussed in more detail with reference to FIG. 7.

[0032] 4A and 4B show cross-sectional views of disposable pump 100 according to some embodiments. More specifically, Figures 4A and 4B show the expansion of elastic component 206 when fluid is introduced through inlet 208 of housing 200 into fluid reservoir 420 (which stores potential energy generated by the expanded elastic component 206) under pressure from a syringe or some other tool for pumping fluid. In some embodiments, air within the system is removed (e.g., vented) through outlet 210 along recess 422 formed by second surface 402b.

[0033] 4A shows an upper ring 410 coupled to a lower ring 414 and ribs 412 coupled therebetween. As described above, the ribs 412 define the shape of the elastic component 206. In some embodiments, the upper ring 410 and the lower ring 414 are coupled by ultrasonic welding and / or solvent bonding. In some embodiments, the upper ring 410 is coupled to the first portion 202 (e.g., via the edge 404) and the lower ring 414 is coupled to the second portion 204 using ultrasonic welding or solvent bonding. The elastic component 206 is positioned across an opening 416 in the second portion 204 to create a cavity 418 (e.g., a space created within the housing 200). In some embodiments, when the first and second portions 202, 204 of the housing 200 are coupled together (via the upper and lower rings 410, 414), the second surface 402b of the first portion 202 stretches the elastic component 206 to the shape of the second surface 402b (e.g., as shown in FIG. 4 ). In some embodiments, the dimensions of both the elastic component 206 and the second surface 402b are such that the elastic component 206 is stretched to a state where the elasticity of the elastic component 206 does not behave in a linear manner. Specifically, the elastic component 206 is stretched to a state where the change in stress of the material of the elastic component 206 is not linearly proportional to the change in strain of the material during operation of the disposable pump 100.

[0034] 4B shows a cross-sectional view of the disposable pump 100 after fluid has been injected through the inlet 208 of the first portion 202 of the housing 200, according to some embodiments. In some embodiments, the injected fluid expands the elastic component 206, creating an expanded fluid reservoir 420. The expanded fluid reservoir 420 is under pressure from a syringe and / or other tool used to inject fluid (through the inlet 208) into the disposable pump 100 (after air has been removed from the system (through the inlet 210) through an outlet along the recess 422 formed based on the second surface 402b). As mentioned above, an external flow restrictor 110 may be used to block the fluid passageway of the first medical tubing 106 from exiting the outlet 210, allowing the fluid reservoir 420 to expand when fluid is injected into the disposable pump 100. To create a substantially constant fluid pumping pressure within fluid reservoir 420, the expansion and subsequent contraction of elastic component 206 is achieved when elastic component 206 is stretched to a state in which its elasticity is nonlinear before fluid is injected into inlet 208. As described above, this state is achieved by the shape and / or dimensions of second surface 402b and / or elastic component 206 during assembly of housing 200. It should be noted that the medical syringe (not shown) and / or any other tool used to inject fluid into disposable pump 100 must inject fluid with sufficient force to overcome the current state of elastic component 206 (e.g., sufficient force to overcome the force generated by contracting elastic component 206). Elastic component 206 must be stretched nonlinearly to form and expand fluid reservoir 420 as shown in FIG. 4B .

[0035] In some embodiments, fluid reservoir 420 is configured to expand to hold a volume of at least 50 mL of fluid. In some other embodiments, fluid reservoir 420 is configured to expand to hold a volume of at least 100 mL of fluid. In still other embodiments, fluid reservoir 420 is configured to expand to hold a volume of at least 250 mL of fluid.

[0036] In general, the fluid must be introduced under sufficient pressure to overcome the potential energy of the initially stretched elastic component 206 (stretched by the second surface 402b). Similarly, the fluid must be introduced under sufficient pressure to further (non-linearly) stretch the elastic component 206 and form the fluid reservoir 420. The potential energy stored by the fluid reservoir 420 is the total amount of energy available to release the fluid (e.g., through the outlet 210). Even after the fluid is completely released, the fluid reservoir 420 has residual potential energy due to the elastic component 206 being stretched on the second surface 402b.

[0037] The flow of fluid through the first medical tubing 106 and / or the second medical tubing 112 may be characterized by the Hagen-Poiseuille equation. Because the flow through the first medical tubing 106 and / or the second medical tubing 112 is assumed to be laminar, the flow may be characterized by the Hagen-Poiseuille equation. Furthermore, due to the properties of the elastic component 206 (e.g., an elastomeric material that exerts a constant pressure on the stored fluid), the pressure generated by the disposable pump 100 (P_device) is considered to be constant. At the same time, the pressure generated by the patient (P_patient) is also assumed to be virtually constant. With these assumptions, the following Hagen-Poiseuille equation may be used to characterize the flow of fluid from the disposable pump 100 to the user 102: P_Device - P_Patient = Flow * (Restrictor Resistance)

[0038] This formula is

number

[0039] According to the Hagen-Poiseuille equation, if there is a constant energy loss over the length of the tubing (as assumed in this embodiment), a constant flow rate of fluid through the tubing can be obtained (e.g., by designing the first medical tubing 106 and / or the second medical tubing 112 as described herein). As mentioned above, since P_device and P_patient are considered to be constant, it can be assumed that there is a constant energy loss over the length of the tubing (e.g., the first medical tubing 106 and / or the second medical tubing 112). In reality, P_patient is negligibly small. Therefore, the flow of the disposable pump 100 is due solely to the constant pressure provided by the stored potential energy of the elastic member 206.

[0040] In other words, the physical design of the P_Device and the first and / or second medical tubing 106, 112 must be considered together to determine a specific value for the flow rate of fluid from the disposable pump 100 through the first and / or second medical tubing 106, 112 to the user 102. Specifically, the pressure (e.g., stored potential energy) maintained by the elastic component 206 is used along with the diameter and / or length of the first and / or second medical tubing 106, 112, respectively, to determine the flow rate for the disposable pump 100.

[0041] 5A and 5B illustrate a flow restrictor component according to some embodiments. In FIG. 5A, a tubing segment 502 (e.g., either the first medical tubing 106 and / or the second medical tubing 112) is shown including a flow restrictor component, such as a pin 506. In some embodiments, the pin 506 has a diameter less than the inner diameter of the tubing segment 502, such that the pin 506 cannot be positioned within the tubing segment 502. In some embodiments, the pin 506 has a diameter greater than the inlet and / or outlet of the air filter 108 and / or the outlet 302 of the second medical tubing 112. In this manner, the pin 506 remains within the tubing segment 502 without moving between different tubing segments (e.g., from the first medical tubing 106 to the second medical tubing 112 or vice versa) and / or to prevent the pin 506 from being injected into the user 102. In some embodiments, pin 506 is fixed (anchored at a specific location) or free (movable along its length) within tube segment 502. In some embodiments, pin 506 has a predetermined length. In some embodiments, pin 506 is made of glass or metal.

[0042] In some embodiments, the pin 506 is configured to adjust (e.g., decrease) the flow rate (e.g., either the first flow rate or the second flow rate as discussed above in FIG. 3). In some embodiments, the adjustment of the flow rate is based in part on the diameter of the pin 506. In some embodiments, the pin 506 is configured to change the shape of the fluid from a cylindrical shape (e.g., cylindrical flow 504) to a torus (ring) shape (e.g., donut flow or torus flow 508). For example, as shown in FIG. 5A, the pin 506 changes the cylindrical flow 504 into a torus flow 508, where the radius of the torus flow 508 is based in part on the diameter of the pin 506. It should be noted that although the torus flow 508 is shown as a single ring, the torus flow 508 is a continuous water flow (as shown in FIG. 5B). In some embodiments, the change in flow shape reduces the flow rate by disrupting the flow and moving the flow around pin 506 (e.g., without expanding or changing the shape of tube segment 502). In some embodiments, the flow rate is further based in part on the predetermined length of pin 506.

[0043] FIG. 5B shows a partial cross-sectional view of the flow restrictor component in FIG. 5A. As shown in FIG. 5B, a cylindrical flow 504 flows from the disposable pump 100 (e.g., via the outlet 210) toward the distal end of the tubing segment 502 (the end of the disposable pump 100 opposite the outlet 210). In some embodiments, the pin 506 reduces the flow rate of the cylindrical flow 504 by reducing the cross-sectional area of ​​the cylindrical flow 504 due to the cross-sectional area of ​​the pin 506, thereby changing the flow to a torus flow 508. Specifically, the area of ​​the cylindrical region of the tubing segment 502 is reduced by the cross-sectional area of ​​the pin 506. In some embodiments, the pin 506 creates an annular section within the tubing segment 502 (e.g., the length of the pin 506). The flow within the annular section of the tubing segment 502 obeys the Poiseuille equation:

number

[0044] As discussed above, because the P_Device and P_Patient are considered constant, the change in pressure can be assumed to be constant over the length of the tubing (e.g., the first medical tubing 106 and / or the second medical tubing 112). Using the above equation, a constant flow rate of fluid passing through the tubing segment 502, including the pin 506, can be obtained (e.g., by designing the first medical tubing 106, the second medical tubing 112, and / or the pin 506 as described herein). In other words, to determine a specific flow rate for fluid passing from the disposable pump 100 through the first medical tubing 106 and / or the second medical tubing 112, including the pin 506, the physical design of the P_Device and the first medical tubing 106, the second medical tubing 112, and / or the pin 506 must both be considered. Specifically, the pressure (e.g., stored potential energy) maintained by elastic component 206 is used in conjunction with the respective diameters of first medical tubing 106, second medical tubing 112, and / or pin 506 to determine the flow rate for disposable pump 100. In practice, P_patient is negligibly small. Thus, the flow of disposable pump 100 is due solely to the constant pressure provided by the stored potential energy of elastic component 206.

[0045] 6A and 6B illustrate another flow restrictor component according to some embodiments. In FIG. 6A, a tubing segment 502 (e.g., first medical tubing 106 and / or second medical tubing 112) is shown that includes another flow restrictor component, such as one or more rigid beads 602. In some embodiments, the one or more rigid beads 602 have a diameter that is less than the inner diameter of the tubing segment 502 such that the one or more rigid beads 602 can be disposed within the tubing segment 502.

[0046] In some embodiments, the one or more rigid beads 602 have a larger diameter than the inlet and / or outlet of the air filter 108 and / or the outlet 302 of the second medical tubing 112. In this manner, the one or more rigid beads 602 remain within the tubing segment 502 without migrating between different tubing segments (e.g., from the first medical tubing 106 to the second medical tubing 112 or vice versa) and / or to prevent the one or more rigid beads 602 from being infused into the user 102. In some embodiments, the one or more rigid beads 602 are fixed (anchored) or unfixed (movable) within the tubing segment 502. In some embodiments, each rigid bead of the one or more rigid beads 602 is identical. In some other embodiments, at least one (or all) of the one or more rigid beads 602 may vary in size (e.g., one or more rigid beads 602 have different diameters).

[0047] In some embodiments, rigid beads 602 can be made of glass or metal. According to various aspects, rigid beads can be sized such that placement of the rigid beads does not expand the tubing (e.g., tube segment 502). As noted above, in some embodiments, one or more rigid beads 602 have a diameter less than the inner diameter of tube segment 502. In this regard, the flow rate through a tubing segment can be determined, at least in part, by a function of the cross-sectional area or diameter of the beads within the tubing, the difference between the cross-sectional area or diameter of the beads and the inner diameter of the tubing, and / or the number of beads within the tubing or the collective mass of the beads within a given region of tube segment 502.

[0048] In some embodiments, one or more rigid beads 602 are configured to adjust (e.g., decrease) a flow rate (e.g., either a first flow rate or a second flow rate as discussed above in FIG. 3 ). In some embodiments, the adjustment of the flow rate is based in part on the diameter of the one or more rigid beads 602. Specifically, the one or more rigid beads 602 are configured to move fluid (e.g., cylindrical flow 504) around their surface or diameter (e.g., without expanding or changing the shape of tube segment 502). The flow rate is based in part on the diameter of the one or more rigid beads (e.g., the area around which the fluid must move). In some embodiments, the flow rate is further based in part on the number of one or more beads 602 in tube segment 502 (e.g., each rigid bead of one or more rigid beads 602 decreases the flow rate).

[0049] FIG. 6B shows a partial cross-sectional view of the flow restrictor component in FIG. 6A. As shown in FIG. 6B, at least two of the one or more rigid beads 602 are present within the tubing segment 502. FIG. 6B also shows a cylindrical flow 504 flowing from the disposable pump 100 (e.g., via the outlet 210) toward the distal end of the tubing segment 502 (the end of the disposable pump 100 opposite the outlet 210). In some embodiments, the one or more rigid beads 602 reduce the flow rate of the cylindrical flow 504 by reducing the cross-sectional area of ​​the cylindrical flow 504 due to the cross-sectional area of ​​the one or more rigid beads 602. Specifically, the area of ​​the cylindrical region of the tubing segment 502 is reduced by the cross-sectional area of ​​the one or more rigid beads 602. In some embodiments, flow within a tube segment 502 containing one or more rigid beads 602 follows the Poiseuille equation as described above (e.g., derived for the respective diameters and / or circumferences of the one or more rigid beads 602).

[0050] 5A and 5B, since the P_Device and P_Patient are considered constant, the change in pressure can be assumed to be constant over the length of the tubing (e.g., the first medical tubing 106 and / or the second medical tubing 112). Using Poiseuille's equation, a constant flow rate of fluid passing through the tubing segment 502 containing one or more rigid beads 602 can be obtained (e.g., by designing the first medical tubing 106, the second medical tubing 112, and / or the one or more rigid beads 602 as described herein). In other words, to determine a specific flow rate for fluid passing from the disposable pump 100 through the first medical tubing 106 and / or the second medical tubing 112 containing one or more rigid beads 602, the physical design of the P_Device and the first medical tubing 106, the second medical tubing 112, and / or the one or more rigid beads 602 must be considered together. Specifically, the pressure (e.g., stored potential energy) maintained by the elastic component 206 is used, along with the respective diameters of the first medical tubing 106, the second medical tubing 112, and / or the one or more rigid beads 602, to determine the flow rate for the disposable pump 100. In practice, P_patient is negligibly small. Thus, the flow of the disposable pump 100 is due solely to the constant pressure provided by the stored potential energy of the elastic component 206.

[0051] In some embodiments, various flow restrictor components may be combined in the tube segment 502. For example, in some embodiments, the tube segment 502 may include a pin 506 and one or more rigid beads 602.

[0052] 7 is a block diagram illustrating a flow control device 700 according to some embodiments. In some embodiments, the disposable pump 100 includes a flow control device 700 configured to control the flow of fluid emitted from the disposable pump 100. In some embodiments, the flow control device 700 is coupled to the housing (e.g., via the first portion 202 and / or the second portion 202 of the housing 200). Alternatively, in some embodiments, the flow control device 700 is fluidly coupled in series with the first medical tubing 106, the second medical tubing 112, and / or other components of the disposable pump 100 (e.g., between the first medical tubing 106 and the outlet 210, between the first medical tubing 106 and the air filter 108, etc.). In some embodiments, the flow control device 700 operates one or more pillows (e.g., inflatable components for blocking fluid pathways), valves, and / or similar components for controlling the available fluid pathways of the disposable pump 100 and selecting a desired flow rate. In some embodiments, one or more pillows, valves, and / or similar components are positioned adjacent to (e.g., behind or before) outlet 210 of disposable pump 100. In some embodiments, flow control device 700 (including one or more pillows, valves, and / or similar components) is a separate component fluidly coupled in series with one or more components of disposable pump 100 (e.g., such that fluid enters an inlet of flow control device 700 at a first flow rate and exits an outlet of flow control device 700 at a second flow rate selected by user 102). Additionally, or alternatively, in some embodiments, one or more pillows, valves, and / or similar components are positioned with first medical tubing 106 and / or second medical tubing 112. Flow control device 700 is configured to achieve a selected flow rate as low as 0.48 ml / hr.

[0053] The flow controller 700 includes one or more processing units (e.g., including a processor, processor core, or other type of controller chip) 702, one or more network or other communication interfaces 704 (e.g., one or more antennas), memory 712, one or more sensors 708, and one or more communication buses 710 for interconnecting these components. The communication bus 710 optionally includes circuitry (sometimes referred to as a chipset) that interconnects and controls communication between the system components. In some embodiments, the flow controller 700 may include an external interface 706 for manually controlling the flow controller 700. In some embodiments, the one or more external interfaces 706 of the flow controller 700 may include input devices such as, for example, a keyboard, a mouse, a touch-sensitive surface and / or controller, a trackpad, USB and / or USB devices, and / or input buttons. In some embodiments, the sensor 708 is used to collect data regarding the flow rate, the pressure maintained within the elastic component 206 (e.g., the fluid reservoir 420), and / or other information needed to determine the flow rate of the disposable pump 100. One or more components of the flow control device 700 are sterilized to prevent contamination of the fluid agent. Similarly, one or more components of the flow control device 700 are isolated from the fluid path of the disposable pump 100 (except for one or more pillows, valves, and / or similar components) to further prevent contamination and / or to prevent fluid from damaging the flow control device 700.

[0054] Memory 712 may be high-speed random access memory, such as DRAM, SRAM, DDR RAM, or other random access solid-state memory devices, and may also include non-volatile memory, such as one or more magnetic disk storage devices, optical disk storage devices, flash memory devices, and / or other non-volatile solid-state storage devices. In some embodiments, memory 712 includes one or more storage devices located remotely from processor 702. Memory 712, or a non-volatile memory device within memory 712, includes a non-transitory computer-readable storage medium. In some embodiments, memory 712 or the computer-readable storage medium of memory 712 stores programs, modules, and / or data structures that can be used to perform one or more operations of flow controller 700. For example, memory 712 may include programs, modules, and / or data structures for operating system 714, network communication module 716, flow control module 718, and device information database 720.

[0055] In some embodiments, the operating system 714 module may include procedures for handling various basic system services and for performing hardware-dependent tasks. The network communications module 716 may be configured to connect the flow controller 700 to other computing devices via one or more communications network interfaces 704 (wireless or wired) and one or more communications networks, such as Ethernet, WiFi, Bluetooth, an integrated services digital network (ISDN) connection, a digital subscriber line (DSL) modem, or a cable modem. Any direct or indirect network connection may be used, including, but not limited to, a telephone modem, a MIB system, an RS232 interface, an auxiliary interface, an optical link, an infrared link, a radio frequency link, a microwave link, a WLANs connection, or other wireless connections. The flow control module 718 is configured to adjust the flow rate as desired. In some embodiments, the flow control module 718 determines the flow rate using the Hagen-Poiseuille equation described above. Specifically, the flow control module 718 can determine the flow rate using data collected from one or more sensors 708 and a device information database 720. In some embodiments, the flow control module 718 is configured to operate automatically (e.g., firmware designed to reach and / or maintain a desired flow rate). Alternatively, or in addition, in some embodiments, the flow controller 700 and flow control module 718 can be operated manually by the user 102 via the external interface 706 and / or the communication interface 704 (e.g., receiving wireless control from a remote device such as a laptop, computer, cell phone, tablet, etc.). In some embodiments, the disposable pump 100 can be controlled via a dedication application.The device information database 720 includes data for the disposable pump 100, such as the length of the first medical tubing 106 and / or the second medical tubing 112, the diameter of the first medical tubing 106 and / or the second medical tubing 112, the maximum capacity of the elastic component 206, the pressure (e.g., potential energy) stored by the elastic component 206 when loaded with various amounts of fluid, the viscosity of one or more different types of fluid, and / or other useful information.

[0056] 8A-8D are flow charts illustrating a method 800 for controlling flow rate of a disposable pump 100 according to some embodiments. Method 800 may be performed in a disposable pump 100 having at least a housing 200 including an elastic component 206. The disposable pump 100 further includes at least a first tube (e.g., first medical tubing 106) fluidly coupled to the housing 200 via an outlet 210, an air filter 108 fluidly coupled to a distal end of the first tube (e.g., first medical tubing 106) via an air filter inlet, a second tube (e.g., second medical tubing 112) fluidly coupled to the air filter 108 via an air filter outlet, and an outlet 302 of the second medical tubing 112 fluidly coupled to the second tube. In some embodiments, the housing 200 comprises a first portion 202 including a first surface 402a and a second surface 402b, where the first surface 402a includes the outlet 210 for dispensing fluid and the second surface 402b is opposite the first surface 402a. In some embodiments, the elastic component 206 is coupled between the first ring 410 and the second ring 414. The first ring 410 and the second ring 414 are affixed to the second surface 402b. In some embodiments, the disposable pump 100 further comprises a second portion 204 configured to receive at least the second surface 402b of the first portion 202, where the first portion 202 and the second portion 204 are coupled.

[0057] Methods consistent with the present disclosure may include at least some, but not all, of the actions depicted in method 800 performed in a different order. Additionally, methods consistent with the present disclosure may include at least two or more steps such as in method 800 performed overlapping or substantially simultaneously in time.

[0058] Method 800 includes expanding (802) elastic component 206 with fluid to store potential energy generated by the fluid within infusion pump 100. In some embodiments, elastic component 206 includes an elastomeric membrane (804). In some embodiments, the membrane is a single layer of silicone (806). In some embodiments, elastic component 206 is configured to expand to hold a volume of at least 50 mL (808). In some embodiments, elastic component 206 is configured to expand to hold a volume of at least 100 mL (810). In some embodiments, elastic component 206 is configured to expand to hold a volume of at least 250 mL (812).

[0059] In some embodiments, the elastic component is formed of a single layer membrane, the housing 200 (of the infusion pump) includes an inlet 208 for receiving fluid, and the method 800 includes the steps of receiving fluid through the inlet and expanding the elastic component 206 to generate potential energy stored by the elastic component 206 based on the fluid received through the inlet (814).

[0060] The method 800 includes directing (816) fluid from the housing 200 through a first tube (e.g., first medical tubing 106) at a first flow rate based in part on potential energy stored by the elastic component 206. In some embodiments, the first flow rate is further based at least in part on an inner diameter of the first tube (818). In some embodiments, the first flow rate is further based at least in part on a length of the first tube (820). Determining the flow rate is based on the potential energy stored by the elastic component 206 and the Hagen-Poiseuille equation, as described above in Figures 4A-6B.

[0061] In some embodiments, the infusion pump further includes an external flow restrictor 110 coupled to an exterior portion of the first tube (822-a), and the method 800 includes applying (822-b) external pressure to the first tube at the infusion pump, the external pressure closing the fluid passageway of the first tube via the external flow restrictor 110. In some embodiments, the method 800 includes removing (822-c) the external pressure from the first tube via the external flow restrictor 110, which opens the fluid passageway of the first tube. As described above in FIGS. 4A and 4B, the external flow restrictor 110 can be used to load (e.g., inject fluid into) the elastic component 206 (e.g., to expand the elastic component 206 and create the fluid reservoir 420).

[0062] The method 800 includes venting (824) air from the fluid through one or more air holes in the air filter 108. The air is vented substantially upstream so that the fluid exiting the air filter is primed free of air. In some embodiments, the air filter includes a membrane filter, and the method 800 includes removing (826) one or more types of contaminants and particles from the fluid in the infusion pump.

[0063] Method 800 includes adjusting (828) a first flow rate of fluid conducted from housing 200 through a first tube to a second flow rate, the second flow rate being based at least in part on an inner diameter of the second tube (e.g., second medical tubing 112). In some embodiments, the inner diameter of the second tube is 0.1905 mm (0.0075 inches) or less (830). In some embodiments, the second tube is a predetermined length, and the second flow rate is further based on the predetermined length (832). In some embodiments, the inner diameter of the first tube and the inner diameter of the second tube are the same (834). In some embodiments, the inner diameter of the first tube and the inner diameter of the second tube are different (836). In some embodiments, the second flow rate is 5 mL / hr or less (838). In some other embodiments, the second flow rate is about 2 mL / hr (840), where about means + / - 0.2 mL / hr in some embodiments. The determination of the flow rate is based on the potential energy stored by the elastic component 206 and the Hagen-Poiseuille equation, as described above in Figures 4A-6B.

[0064] The method 800 includes dispensing (842) the fluid to the user 102 via one or more components fluidly coupled to the outlet 302 of the second medical tubing 112. In some embodiments, the outlet 302 of the second medical tubing 112 is a fixed male luer (844). In some embodiments, the one or more components configured to connect to the outlet 302 of the second medical tubing 112 include a skin patch, a needle, a cannula, and a catheter (846).

[0065] In some embodiments, the infusion pump includes a flow restrictor component (e.g., pin 506 and / or rigid bead 602) within the first tube, where the flow restrictor component has a diameter less than the inner diameter of the first tube (848). In some embodiments, the diameter of the flow restrictor component is greater than the diameter of the inlet and / or outlet of air filter 108 and / or outlet 302 of second medical tubing 112 (850). In this manner, the flow restrictor component remains within a particular tube segment (as described above in FIGS. 5A-6B ) and / or is not infused into the user 102. In some embodiments, the flow restrictor component is not secured within the first tube (852). In some other embodiments, the flow restrictor component is secured within the first tube (854). It should be noted that while the examples provided herein have a flow restrictor component within the first tube, a flow restrictor component may be within the second tube and / or both the first and second tubes.

[0066] In some embodiments, the flow restrictor component is a pin 506 configured to change the shape of the fluid from a cylindrical shape (e.g., cylindrical flow 504) to a torus shape (e.g., torus flow 508) (856). In some embodiments, the pin 506 has a predetermined radius, and the first flow rate is further based in part on the radius of the pin 506 (858). In some embodiments, the pin 506 has a predetermined length, and the first flow rate is further based in part on the predetermined length of the pin (860). The effect of the pin 506 on the flow was described above in connection with FIGS. 5A and 5B. In some embodiments, the pin 506 is made of glass or metal (862).

[0067] In some other embodiments, the flow restrictor component is one or more rigid beads configured to move fluid around the diameter of the one or more rigid beads, and the first flow rate is further based in part on the diameter of the one or more rigid beads, wherein the one or more rigid beads do not expand the first tube when fluid is moving around the diameter of the one or more rigid beads (864). In some embodiments, the one or more rigid beads can be of variable size (866). Specifically, all of the rigid beads can be the same (having the same diameter) or different (having varying diameters between the rigid beads). The effect of one or more rigid beads 602 on flow was described above in connection with FIGS. 6A and 6B. In some embodiments, at least two rigid beads are included within the first tube (868). In some embodiments, the one or more rigid beads are made of glass or metal (870).

[0068] In some embodiments, the infusion pump further includes a controller chip (e.g., flow controller 700), and method 800 operates 872 a valve in the infusion pump to control a first flow rate of the fluid. In some embodiments, the controller chip is controlled 874 via USB. In some other embodiments, the controller chip is controlled 876 wirelessly (e.g., via a wireless protocol such as Bluetooth or a dedicated application). In some embodiments, the controller chip includes firmware for automatically controlling the flow rate 878. The flow controller 700 is controlled to achieve a selected flow rate (e.g., no more than 0.48 ml / hr). In some embodiments, one or more components of the flow controller 700 (e.g., wireless component 704, external interface 706, sensor 708, etc.) are sterilized and isolated from the fluid path to prevent contamination of the fluid medication. The flow controller 700 was discussed in detail above in connection with FIG. 7.

[0069] The above description has been provided to enable one skilled in the art to practice the various configurations described herein. While the subject technology has been specifically described with reference to various diagrams and configurations, it should be understood that these are for illustrative purposes only and should not be considered as limiting the scope of the subject technology.

[0070] Those skilled in the art will understand that the various illustrative blocks, modules, elements, components, methods, and algorithms described herein can be implemented as electronic hardware, computer software, or a combination of both. To illustrate this interchangeability of hardware and software, the various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends on the particular application and design constraints imposed on the overall system. The described functionality can be implemented in various ways for each particular application. The various components and blocks can be arranged differently (e.g., placed in a different order or partitioned differently) without departing from the scope of the subject technology.

[0071] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of sample approaches. It is understood that the specific order or hierarchy of steps in the processes can be rearranged based on design preferences. Some of the steps may occur simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0072] Examples of subject matter art as clauses

[0073] Various examples of aspects of the present disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Identification of figures and reference numbers is provided below solely for illustration and purposes of illustration, and the clauses are not intended to be limited by these identifications.

[0074] Clause 1. An infusion pump comprising: a housing including an elastic component configured to expand and store potential energy generated by a fluid within the infusion pump; a first tube fluidly coupled to an outlet of the housing, the first tube configured to direct fluid from the housing at a first flow rate based in part on the potential energy stored by the elastic component; an air filter fluidly coupled to a distal end of the first tube via an air filter inlet, the air filter configured to exhaust air from the fluid through one or more air holes, the air being exhausted substantially upstream such that fluid exiting the air filter is air-free and primed; a second tube fluidly coupled to the air filter via an air filter outlet, the second tube configured to adjust the first flow rate of fluid directed from the housing through the first tube to a second flow rate, the second flow rate based at least in part on an inner diameter of the second tube, and an outlet of the second tube configured to fluidly couple to one or more components for dispensing fluid to a user; An infusion pump having

[0075] Clause 2. The infusion pump of clause 1, wherein the inner diameter of the second tube is 0.1905 mm (0.0075 inches) or less.

[0076] Clause 3. The infusion pump of clause 1 or 2, wherein the second tube is of a predetermined length and the second flow rate is further based on the predetermined length.

[0077] Clause 4. An infusion pump described in any one of clauses 1 to 3, wherein the inner diameter of the first tube and the inner diameter of the second tube are the same.

[0078] Clause 5. An infusion pump according to any one of clauses 1 to 3, wherein the inner diameter of the first tube and the inner diameter of the second tube are different.

[0079] Clause 6. An infusion pump described in any one of clauses 1 to 5, further comprising a flow restrictor component within the first tube, the flow restrictor component having a diameter less than the inner diameter of the first tube.

[0080] Clause 7. The infusion pump of clause 6, wherein the flow restrictor component is a pin configured to change the shape of the fluid from a cylindrical shape to a torus shape, the pin having a predetermined radius, and the first flow rate is further based in part on the predetermined radius of the pin.

[0081] Clause 8. The infusion pump of clause 6 or 7, wherein the flow restrictor component is a pin configured to change the shape of the fluid from a cylindrical shape to a torus shape, the pin having a predetermined length, and the first flow rate is further based in part on the predetermined length of the pin.

[0082] Clause 9. An infusion pump described in any one of clauses 6 to 8, wherein the flow restrictor component is one or more rigid beads configured to move fluid around the diameter of the one or more rigid beads, the first flow rate is further based in part on the diameter of the one or more rigid beads, and the one or more rigid beads do not expand the first tube when the fluid is moving around the diameter of the one or more rigid beads.

[0083] Clause 10. The infusion pump of clause 9, wherein at least two rigid beads are contained within the first tube.

[0084] Clause 11. An infusion pump as described in any one of clauses 6 to 10, wherein the flow restrictor component is not fixed within the first tube and is configured to move along the length of the first tube.

[0085] Clause 12. An infusion pump as described in any one of clauses 6 to 10, wherein the flow restrictor component is fixed within the first tube and is configured to remain in a predetermined position on the first tube.

[0086] Clause 13. An infusion pump described in any one of clauses 1 to 12, wherein the outlet of the second tube is a fixed male luer.

[0087] Clause 14. An infusion pump as described in any one of clauses 1 to 13, wherein the air filter includes a membrane filter configured to remove one or more types of contaminants from the fluid.

[0088] Clause 15. An infusion pump as described in any one of clauses 1 to 14, further comprising an external flow restrictor coupled to an outer surface portion of the first tube, the external flow restrictor configured to apply external pressure to the first tube or remove external pressure therefrom, thereby respectively closing or opening the fluid passage of the first tube.

[0089] Clause 16. An infusion pump as described in any one of clauses 1 to 15, further comprising a controller chip configured to operate a valve to control a first flow rate of the fluid.

[0090] Clause 17. An infusion pump according to any one of clauses 1 to 16, wherein the second flow rate is 5 mL / hr or less.

[0091] Clause 18. An infusion pump described in any one of clauses 1 to 17, wherein the one or more components configured to connect to the outlet of the second tube include a skin patch, a needle, and a catheter.

[0092] Clause 19. An infusion pump described in any one of clauses 1 to 18, wherein the elastic component is formed of a single-layer membrane, the housing includes an inlet for receiving a fluid, and the fluid received through the inlet causes the elastic component to expand and generates potential energy that is stored by the elastic component.

[0093] Clause 20. An infusion pump according to clause 19, wherein the monolayer membrane is an elastomeric membrane.

[0094] Clause 21. An infusion pump according to any one of clauses 1 to 20, wherein the elastic component is configured to expand to hold a volume of at least 50 mL of fluid.

[0095] Clause 22. An infusion pump described in any one of clauses 1 to 21, wherein the housing includes a first part having first and second surfaces, the first surface including an outlet of the housing for dispensing fluid, and a second surface opposite the first surface including an elastic component coupled between the first ring and a second ring affixed to the second surface, and a second part configured to accommodate the second surface of the first part, wherein the first part and the second part are coupled.

[0096] Clause 23. A method of infusing a fluid into a patient, the method comprising: in an infusion pump having a housing including an elastic component; a first tube fluidly coupled to the housing through an outlet of the housing; an air filter fluidly coupled to a distal end of the first tube through an air filter inlet; a second tube fluidly coupled to the air filter through an air filter outlet; and an outlet of the second tube fluidly coupled to one or more components, the method comprising the steps of: expanding the elastic component with fluid to store potential energy generated by the fluid within the infusion pump; and generating potential energy stored in part by the elastic component. directing fluid from the housing through a first tube at a first flow rate based on the potential energy generated; venting air from the fluid through one or more air holes in an air filter, the air being vented substantially upstream so that the fluid exiting the air filter is primed and free of air; adjusting the first flow rate of the fluid directed from the housing through the first tube to a second flow rate, the second flow rate being based at least in part on an inner diameter of the second tube; and distributing the fluid to a user via one or more components.

[0097] Further considerations

[0098] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of sample approaches. It is understood that the specific order or hierarchy of steps in the processes can be rearranged based on design preferences. Some of the steps may occur simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0099] There may be many other ways to implement the subject technology. The various functions and elements described herein may be partitioned differently than shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology by those skilled in the art without departing from the scope of the subject technology.

[0100] As used herein, the phrase "at least one of" preceding a list of items, with the term "and" or "or" separating any of the items, modifies the list as a whole, not each member (e.g., each item) of the list. The phrase "at least one of" does not require the selection of at least one of each listed item; rather, the phrase allows for the inclusion of at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" mean A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C, respectively.

[0101] Furthermore, to the extent that terms like "include," "have," and the like are used in the description or claims, such terms are intended to be inclusive in the same manner as the term "comprise" is interpreted as a transitional term in the claims. The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0102] Reference to an element in the singular is not intended to mean "one and only one" unless specifically stated otherwise, but rather "one or more." The term "some" means one or more. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject technology. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly set forth in the above description.

[0103] While several aspects and embodiments of the subject technology have been described, they have been presented by way of example only and are not intended to limit the scope of the subject technology. Indeed, the novel methods and systems disclosed herein may be embodied in a variety of other forms without departing from the spirit thereof. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the subject technology.

Claims

1. It is an infusion pump, A housing including an elastic component configured to expand and store potential energy generated by the fluid in the infusion pump, A first tube fluidly coupled to the outlet of the housing, the first tube configured to guide the fluid from the housing at a first flow rate, partly based on the potential energy stored by the elastic component, A control device chip configured to operate a valve to control the first flow rate of the fluid, An air filter fluidically coupled to the distal end of the first tube via an air filter inlet, the air filter configured to discharge air from the fluid through one or more air holes, the air being substantially discharged upstream, thereby priming the fluid so that it does not contain air, A second tube fluidly coupled to the air filter via the air filter outlet and It has, The second tube is configured to adjust the first flow rate of the fluid introduced from the housing via the first tube to a second flow rate, the second flow rate being at least partially based on the inner diameter of the second tube, and An infusion pump wherein the outlet of the second tube is configured to be fluidically coupled to one or more components for distributing the fluid to a user.

2. The infusion pump according to claim 1, wherein the inner diameter of the second tube is 0.1905 mm (0.0075 inches) or less.

3. The infusion pump according to claim 2, wherein the second tube is of a predetermined length, and the second flow rate is further based on the predetermined length.

4. The infusion pump according to claim 3, wherein the inner diameter of the first tube and the inner diameter of the second tube are the same.

5. The infusion pump according to claim 3, wherein the inner diameter of the first tube and the inner diameter of the second tube are different.

6. The infusion pump according to claim 1, further comprising a flow limiter component within the first tube, wherein the flow limiter component has a diameter less than the inner diameter of the first tube.

7. The infusion pump according to claim 6, wherein the flow limiter component is a pin configured to change the shape of the fluid from a cylindrical shape to a torus shape, the pin having a predetermined radius, and the first flow rate is partially further based on the predetermined radius of the pin.

8. The infusion pump according to claim 6, wherein the flow limiter component is a pin configured to change the shape of the fluid from a cylindrical shape to a torus shape, the pin having a predetermined length, and the first flow rate is partially further based on the predetermined length of the pin.

9. The infusion pump according to claim 6, wherein the flow limiter component is not fixed within the first tube and is configured to move the length of the first tube.

10. The infusion pump according to claim 1, wherein the air filter includes a membrane filter configured to remove one or more types of contaminants and particles from the fluid.

11. The infusion pump according to claim 1, further comprising an external flow limiter coupled to the outer surface portion of the first tube, the external flow limiter being configured to apply or remove external pressure to the first tube, thereby closing or opening the fluid passages of the first tube, respectively.

12. The infusion pump according to claim 1, wherein the second flow rate is 5 mL / hr or less.

13. The infusion pump according to claim 1, wherein the one or more components configured to connect to the outlet of the second tube include a skin patch, a needle, and a catheter.

14. The elastic component is formed of a single layer film, The housing includes an inlet for receiving the fluid, and the fluid received through the inlet expands the elastic component to generate the potential energy stored by the elastic component. The infusion pump according to claim 1.

15. The infusion pump according to claim 14, wherein the single-layer membrane is an elastomer membrane.

16. The infusion pump according to claim 14, wherein the elastic component is configured to expand to hold a volume of at least 50 mL of the fluid.

17. The aforementioned housing is A first portion comprising a first and a second surface, wherein the first surface includes the outlet of the housing for distributing the fluid, and the second surface opposite the first surface includes the elastic component coupled between a first ring and a second ring fixed to the second surface, A second part configured to accommodate the second surface of the first part, wherein the first part and the second part are joined together. An infusion pump according to claim 1, including the following:

18. A method of injecting fluid into a patient, A housing including an elastic component, A first tube fluidly coupled to the housing via the outlet of the housing, An air filter fluidly coupled to the distal end of the first tube via an air filter inlet, A second tube fluidly coupled to the air filter via the air filter outlet, The outlet of the second tube, which is fluidly coupled to one or more components, A control chip configured to operate a valve to control the first flow rate of the fluid, In an infusion pump having, The steps include: expanding the elastic component with the fluid in order to store the potential energy generated by the fluid in the infusion pump; The steps include: guiding the fluid from the housing through the first tube at a first flow rate partially based on the potential energy stored by the elastic component; A step of discharging air from the fluid through one or more air holes of the air filter, wherein the air is discharged substantially upstream, thereby priming the fluid so that it does not contain air as it exits the air filter; A step of adjusting the first flow rate of the fluid introduced from the housing through the first tube to a second flow rate, wherein the second flow rate is at least partially based on the inner diameter of the second tube, The steps include distributing the fluid to the user via one or more of the aforementioned components, and Methods that include...

19. The method according to claim 18, wherein the first tube has a flow limiter component in the form of a pin having a diameter less than the inner diameter of the first tube, and the step of guiding the fluid through the first tube has a pin that changes the shape of the fluid from cylindrical to torus and sets the first flow rate based in part on a predetermined radius or predetermined length of the pin.

20. The method according to claim 19, wherein the flow limiter component is not fixed within the first tube, and the step of guiding the fluid through the first tube includes a flow limiter that moves freely along the length of the first tube.

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