A medical pump is a type of pump used in healthcare to deliver medicaments to patients. The pumps are used in a variety of settings including hospitals, clinics, and the home, with the latter requiring higher levels of self-administration by the patient. The pump typically consists of a container, an inlet for filling the container, an outlet for divesting the container contents, an actuator for expelling the contents, along with a variety of needles, nozzles, and tubing fitted to direct the contents between the container and the patient.
One type of pump used in medicine is a syringe, which typically includes a body, a plunger, and a push-pull stem. The syringe is ubiquitous in medicine for administration of medicaments, and is also used in other fields to withdraw, measure, and distribute substances.
Despite widespread use, the syringe has unaddressed difficulties that are especially acute for self-administration by the patient including techniques of accurately connecting with the body, ergonomically moving the plunger, problems with dosing accuracy, maintaining sterility in the home environment, medicament preservation of active pharmaceutical ingredients and active substance expiration including cold chain, oxygen (air) exposure and light controls. Safety with sharps handling and disposal is an additional challenge especially for self-administration accessibility. Other challenges include the delivery of higher viscosity fluids in larger volumes, such as with biologics, which often require extensive delivery times for safe and effective treatment. The issues create further challenges when adopting pumps for infusion and wearables, including higher complexity which leads to administration errors and patient non-compliance with treatment regimens, resulting in substandard therapy.
The field of drug therapy self-administration offers patients additional value including convenience of home therapy, less travel and time to visit clinics, less burden on care providers, less exposure to pathogens in clinic settings, more personal privacy, lower overall personal and system costs, and greater self-determination in controlling therapy results. Self-administration is expected to lead to faster recovery, improved satisfaction, and patient independence all resulting in higher quality of life.
A pump according to an example of the present disclosure includes a container that has an interior volume for holding a substance, at least one outlet associated with the interior volume for discharging the substance, and a driver disposed in the interior volume. The driver has a stored potential energy that is releasable as kinetic energy and, upon release, the driver is expandable against the substance in the interior volume to thereby discharge the substance through the at least one outlet.
In a further embodiment of the foregoing embodiment, the driver includes a casing and a spring device in the casing. The casing is evacuated to define a pressure differential that stresses the spring device to provide the stored potential energy.
In a further embodiment of any of the foregoing embodiments, the driver is configured to release the stored potential energy by release of the pressure differential.
In a further embodiment of any of the foregoing embodiments, the driver has a pressure equalization port that is operable to release the pressure differential and, upon release, the spring device expands to increase the volume of the casing and thereby generates a secondary vacuum in the casing.
In a further embodiment of any of the foregoing embodiments, the container includes first and second ends. The at least one outlet is in the first end, and the pressure equalization port is in the first end.
In a further embodiment of any of the foregoing embodiments, the driver includes first and second segments. The first segment includes a first seal that seals against an interior surface of the container and the second segment includes a second seal that seals against an interior surface of the container. The first and second seals isolate a region from the remainder of the interior volume.
In a further embodiment of any of the foregoing embodiments, the driver includes a spring device in the region. The region is evacuated to define a pressure differential that stresses the spring device to provide the stored potential energy. The first segment is translatable in the container, the second segment is fixed in the container, and upon release of the pressure differential the spring device moves the second segment against the substance to discharge the substance through the at least one outlet.
A further embodiment of any of the foregoing embodiments includes a conduit in the container and extends through the driver. The conduit connects the interior volume with the at least one outlet for discharging the substance through the conduit.
A further embodiment of any of the foregoing embodiments includes a passive valve associated with the conduit. The passive valve is held closed by the pressure differential and opening upon release of the pressure differential to permit the substance to flow into the conduit.
In a further embodiment of any of the foregoing embodiments, the at least one outlet includes an attachment selected from the group consisting of a needle, a roller ball, a brush, a foam applicator, a directional nozzle, and combinations thereof.
A further embodiment of any of the foregoing embodiments includes a stem that is attached with the driver. The stem is moveable to retract the driver in the container and thereby draw the substance into the interior volume.
In a further embodiment of any of the foregoing embodiments, the driver occupies a region in the container, and the region is fluidly isolated from the interior volume.
A further embodiment of any of the foregoing embodiments includes a thermal material in the driver. The thermal material is actively responsive to release of the driver to change the temperature of the substance.
In a further embodiment of any of the foregoing embodiments, the container includes a window and the driver includes a marker. The marker becomes visible through the window upon release of the driver.
A pump according to an example of the present disclosure includes a container that has an interior volume, a substance in the interior volume, at least one outlet associated with the interior volume for discharging the substance, and at least one evacuated driver disposed in the interior volume. The evacuated driver defines a pressure differential that stresses a spring device of the evacuated driver to store a potential energy. The evacuated driver has a pressure equalization port that is operable to release the pressure differential and, upon release, to cause the potential energy in the spring device to convert to kinetic energy such that the evacuated driver expands against the substance in the interior volume and thereby discharge the substance through the at least one outlet.
In a further embodiment of any of the foregoing embodiments, the pressure equalization port includes a regulator that restricts inflow into the evacuated driver in proportion to expansion of the evacuated driver.
In a further embodiment of any of the foregoing embodiments, the regulator includes at least one passive flow restrictor selected from an orifice, a flow restriction tube, an open cell foam, a viscous fluid, and combinations thereof.
In a further embodiment of any of the foregoing embodiments, the regulator includes at least one active flow control selected from a valve, an electrical element, a solenoid, a phase change material, a thermally degradable material, a fixed volume pump, and combinations thereof.
In a further embodiment of any of the foregoing embodiments, the regulator includes the fixed volume pump, the fixed volume pump being operable to release a fixed volume of air into the evacuated driver to incrementally release the pressure differential.
In a further embodiment of any of the foregoing embodiments, the at least one evacuated driver includes two evacuated drivers, and each of the two evacuated drivers is segmented into a moveable first segment, a fixed second segment, and the two evacuated drivers are interconnected by a shaft.
A method for controlling discharge from a pump according to an example of the present disclosure includes providing a pump as in any of the foregoing embodiments, connecting the pump to a patient for delivery of a medicament, releasing the pressure differential via the pressure equalization port to cause the potential energy in the spring device to convert to kinetic energy such that the evacuated driver expands against the medicament in the interior volume and thereby discharges the medicament through the at least one outlet. The expansion draws an inflow into the evacuated driver through the pressure equalization port, and after delivery of the medicament to the patient, disconnects the pump from the patient.
An example method for assembling a pump according to an example of the present disclosure includes providing a container that has an interior container volume and an outlet associated with the interior volume, introducing a medicament into the interior volume, installing an evacuated driver at least partially into the interior volume of the container. The evacuated driver has a stored potential energy that is releasable as kinetic energy and, upon release, the evacuated driver is expandable against the medicament in the interior volume to thereby discharge the substance through the outlet.
The present disclosure may include any one or more of the individual features disclosed above and/or below alone or in any combination thereof.
The various features and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description. The drawings that accompany the detailed description can be briefly described as follows.
In this disclosure, like reference numerals designate like elements where appropriate and reference numerals with the addition of one-hundred or multiples thereof designate modified elements that are understood to incorporate the same features and benefits of the corresponding elements.
The pump 20 is generally comprised of a container 22. In this example, the container 22 defines a central axis A and has first and second end walls 22a/22b and a side wall or walls 22c. The walls 22a/22b/22c define an interior container volume 22d for holding a substance (fluid) that is to be pumped. As an example, the size of the interior container volume 22d may generally be from 1 mL to 1000 mL, but the size is not particularly limited and may be scaled up or down for a particular implementation. In this example, the container 22 is cylindrical and is formed of a plastic material. However, the geometry and material of the container 22 can be varied. For example, the container 22 may alternatively be made of metal, glass, ceramic, or elastomer, or combinations of different materials, including multilayered structures. The container 22 may be opaque, translucent, or transparent to visible light, and may be symmetrical or asymmetrical. The substance may be pre-loaded in the container 22 such that the pump 20 is ready for use, but the substance may alternatively be loaded into the container on-demand in preparation of the pump 20 for an imminent use.
The pump 20 includes at least one outlet 24 that is connected with the interior container volume 22a for discharging the substance. In the illustrated example, there is one outlet 24 and it is located at the second end wall 22b. It is to be appreciated, however, that there could be additional outlets, such as two outlets, three outlets, or more than three outlets, and the outlet or outlets may be located elsewhere on the container 22.
The pump 20 further includes a driver 26 disposed in the interior container volume 22d. The driver 26 driver occupies a region of the container 22, and the region is fluidly isolated from (i.e. sealed from) the interior container volume 22d. The driver 26 has a stored potential energy that is releasable as kinetic energy. Upon release, as shown in
The driver 26 in this example includes a casing 28 and a spring device 30 in the casing 28. The casing 28 is expandable and collapsible. In this regard, the casing 28 may include, but is not limited to, an elastically flexible sack, a convoluted sack, or other mechanical structure that permits the casing to expand/collapse. For example, the casing 28 may be of a monolayer or multi-layer wall construction. The interior of the casing 28 is evacuated and thus defines a pressure differential across the spring device 30, relative to the surrounding ambient environment pressure. That is, the vacuum in the casing 28 relative to the surrounding ambient pressure causes the casing 28 to collapse around, and thus stress, the spring device 30 to provide the stored potential energy. In general, the vacuum pressure in the casing 28 may be a low as <10−3 Pa but may be scaled up or down for a particular implementation. The spring device 30 in the illustrated example is a coil spring. Alternatively, the spring device 30 may include, but is not limited to, a compressible foam, a compressible elastic, a compressible textile, a compressible fluid, a collapsible lattice structure, torsion spring, constant force spring (e.g., clock spring) or combinations of different types of these or other types of springs, as long as the spring device 30 can be stressed under the vacuum force of the collapsed casing 28 and to store potential energy and then elastically recover to release the potential energy once the pressure differential is equalized. In some instances, the spring device 30 may compress when stressed (e.g., a coil spring or foam), but in other instances the spring device 30 may twist or otherwise deform when stressed (e.g., torsion spring or a constant force spring).
The vacuum in the casing 28 holds the spring device 30 in its stressed, elevated potential energy state (relative to the spring device 30 at rest) until the pressure differential is released. The pressure differential is released by opening the casing 28 to the surrounding ambient environment. Once opened, air or other substances from the surrounding environment enters into the casing 28, thereby at least partially equalizing the initial vacuum in the casing 28 with the ambient surroundings. Once equalized, or as the vacuum equalizes, the vacuum force holding the casing 28 in its collapsed state decreases and the potential energy of the spring device 30 converts to kinetic energy. Under the force of the kinetic energy of the spring device 30, the casing 28 expands to take up at least a portion of the interior container volume 22d. The expansion of the casing 28 increases the volume of the casing 28, which generates a secondary vacuum in the casing 28 that draws an inflow of air or other substances from the surrounding environment into the casing 28 to equalize the secondary vacuum. In the figures herein, flow is represented by block arrows. The inflow to equalize this secondary vacuum may be controlled to thereby control the expansion on the casing 28 and concomitant discharge of the substance from the pump 20, as the secondary vacuum is generally proportional to the displaced interior container volume 22d drawing the ambient surroundings into the casing 28 through inlet port 32.
The casing 28 may be opened to release the pressure differential via an inlet port 32. The inlet port 32 extends thorough the first end wall 22a and connects the interior of the casing 28 to the surrounding ambient environment. The inlet port 32 is initially sealed, thereby preserving the vacuum in the casing 28 so that the potential energy is stored until released to activate the pump 20. The release can be triggered manually or in an automated fashion by opening the inlet port 32, such as by breaking a seal associated with the inlet port 32, opening a valve associated with the inlet port 32, or by operating or activating a regulator associated with the inlet port 32.
The regulator 34 is selected from an orifice, a flow restriction tube, a fixed volume pump, an open cell foam, a valve, an electrical element, a viscous fluid, a mechanical clock valve, a solenoid, a wax, a thermally degradable material, or combinations thereof, further embodiments of which will be discussed in subsequent examples. A regulator 34 such as an orifice, a flow restriction tube, an open cell foam, a viscous fluid, or combinations thereof operate passively, while other types of regulators, such as a valve, an electrical element, a solenoid, a phase change material, a thermally degradable material, a fixed volume pump, or combinations thereof, are operated with an active control to modulate flow restriction and thus discharge. For example, the vacuum created per displacement of the driver 26 decreases as the driver 26 expands (because the linear distance of the displacement creates a smaller change in volume). Thus, if left unmodulated, the discharge rate may vary as the driver 26 expands. In this regard, the active regulators may be used to facilitate leveling out the speed by which the substance is expelled from the container 22.
Additionally or alternatively, the discharge rate may be directly controlled by a regulator 34 associated with the outlet 24. For example, a valve, orifice, or other type of regulator 34 restricts outflow of the substance to control the discharge rate. In further examples, regulators 34 are used in association with both the inlet port 32 and the outlet 24. Such use at both the inlet 32 and outlet 24 may facilitate finer control over the discharge rate.
In one example, the regulator 34 varies the inflow in order to facilitate a more uniform discharge of the substance. For instance, for many types of springs the spring force decreases as the spring recovers (e.g., decompresses). Therefore, with no control of the inflow, the force of expansion against the substance would decrease over the time period in which the spring recovers. Since the force of expansion is proportional to the rate of discharge of the substance from the pump 20, the rate of discharge would also decrease over the time period in which the spring recovers. In this regard, the inflow can be increased over the time period in which the spring recovers in order to produce a constant force of expansion, and thus a constant rate of discharge.
Optionally, the pump 320 may further include a thermal material 41 that serves to change the temperature of the substance. The thermal material 41 includes one or more compounds or elements that are either exothermically or endothermically reactive to warm or cool, respectfully, the substance. The warming may be used to warm drugs, biologics, blood, hydration, or plasma to mitigate thermal shock when entering the body, or to reduce a dynamic viscosity of a viscous fluid or solid to enable injection through an elongated needle. The cooling may be used to reduce injection pain at a needle injection site of a patient.
In one example, the thermal material 41 includes iron powder, water, a salt, and activated carbon or vermiculite. Upon inflow of air (oxygen) into the driver 126, the iron oxidizes in an exothermic reaction to produce heat that warms the substance. The water serves as a catalyst for the oxidation reaction, the salt regulates the reaction rate and prevents the mixture from rapidly drying out, and the activated carbon or vermiculite serves as an insulator to help retain the heat. In additional examples, the thermal material 41 includes one or more of calcium nitrate, magnesium sulfate, urea, calcium nitrate, potassium chloride, baking soda, salts of various forms and types, ammonium nitrate, silica, cellulose, glycol, sodium polyacrylate, and derivatives of these compounds.
The pump 320 may further include a passive valve 42 located at the inlet of the conduit 40. The passive valve 42 is initially held in a closed state by the vacuum in the region 38. Upon release of the vacuum, the passive valve 42 opens, permitting flow of the substance into the conduit 40. A pressurized gas pocket may initially be provided in the interior container volume 22d with the substance to facilitate keeping the passive valve 42 in the closed state initially. The passive valve 42 eliminates the need for a separate valve that has to be operated by the user or through a controller.
Upon retraction as shown in
In the example shown, the pump 20 is used in a vertical position, with the substance above the driver 26. The base 634a may be depressed via a downward movement of the container 22 with the base 634a supported against a fixed surface. Such a configuration may be useful for dermatological implementation, such as a soap or cream dispenser, in which the user can simply hand-push the container 22 downwardly to dispense the substance.
The pumps described herein may also be used in combination with various types of attachments at the outlet 24. For example, as shown in
In prior examples, the outlet 24 opens in an axial direction with respect to the central axis A of the container 22. However, as shown in
The driver 26 may include at least one marker 64 which becomes visible through a window 66 of the container 122. On release and expansion of the driver 26, the marker 64 expands from its compressed state on the surface of the driver 26. The marker 64 may include combinations of symbols, letters, numbers, bar codes, graphics, photos, and/or images for conveying information. For example, on dispensing the substance from of the container 122, the marker 64 becomes visible through the window 66 of container 122 and the user, with a smart phone scanner, may retrieve an online coupon as a reward for using and dispensing the product susbstance. In another example, the marker 64 enables the user to visualize the amount of substance dispensed or estimate the amount of substance remaining in the container. In another example, the window 66 or markings on the container surface near the window 66 includes a complementary marker. Once the marker 64 is exposed, the marker 64 and the complementary marker together form a full marker. For example, the complementary marker shows a portion of a coupon value and the marker 66 completes the value. Since the complementary marker is initially visible, the user may be enticed to use the product in order to see what the value of the coupon will be once completed by the marker 66. Such features may be useful for consumer substances, such as detergents or cosmetics. Moreover, the driver 26 in this case serves as an anti-theft feature, as the coupon is not visible/useable until the driver 26 is released and the coupon cannot, therefore, be stolen without using the device.
As indicated, the end-uses of the pumps disclosed herein are not limited. One example useful implementation is in dermatology or pharmaceutical field, where it may be necessary to keep the substance and the drive separate to prevent oxygen from degrading the substance (e.g., a dermatology drug) or to prevent oxygen (air) from contributing to bacteria/fungal growth in the substance. The pump also enables long term storage of the potential energy before use. Additionally, by eliminating a battery and a motor from a drug delivery device, the amount of landfill e-waste is reduced. Furthermore, the use of the pressure differential enables devices that use the pump to be simplified with lower mechanical complexity and, in some cases, reduce the stress on key parts of the devices. For example, instead of a mechanical latch with high, focused forces the pump holds the energy under a distributed pressure load and releases the energy by release/breaking the vacuum.
An example method for use of any of the pumps herein in the medical field includes connecting the pump to a patient for delivery of a medicament, releasing the pressure differential via the pressure equalization port to cause the potential energy in the spring device to convert to kinetic energy such that the evacuated driver expands against the medicament in the interior volume and thereby discharges the medicament through the at least one outlet, the expansion drawing an inflow into the evacuated driver through the pressure equalization port, and after delivery of the medicament to the patient, disconnecting the pump from the patient. As indicated, the disclosed pumps are not limited to the medical field and may also be used for delivery of other types of substances such as but not limited to, cosmetics, condiments, soaps, cleaning solutions, oils, or mixtures of these and/or other substances. For instance, the pump with the substance in it is brought into proximity of a point of delivery and the pressure differential is released in order to discharge the substance toward the point of delivery.
The configurations disclosed herein also facilitate maximizing the use of the container contents. The expansion of the driver wipes the container walls and pushes the lowest contents towards the dispensing point, which existing squeeze containers, hand pumps, or shake containers (i.e., the ketchup bottle dilemma) do not do. As a result, there may be advantages in food utilization (i.e., maximize food use by reducing wasted food) and reduction in the need for plastic bottles. It also reduces industrial waste in the production and consumption of cosmetics, detergents, soaps, and medications by maximizing use at the point of dispensing. Another advantage lay in reducing skin contact with a container substance. For example, in existing cosmetic containers skin bacteria can ruin expensive contents when the user must scoop the cosmetic from a container with fingers. The use of the evacuated drive to push the contents to the user without skin contact enables better preservation of the cosmetic for long-term preservation between applications, which may be especially valuable for specialty cosmetics with elevated costs for small volumes of substance.
Although a combination of features is shown in the illustrated examples, not all of them need to be combined to realize the benefits of various embodiments of this disclosure. In other words, a system designed according to an embodiment of this disclosure will not necessarily include all of the features shown in any one of the Figures or all of the portions schematically shown in the Figures. Moreover, selected features of one example embodiment may be combined with selected features of other example embodiments.
The preceding description is exemplary rather than limiting in nature. Variations and modifications to the disclosed examples may become apparent to those skilled in the art that do not necessarily depart from this disclosure. The scope of legal protection given to this disclosure can only be determined by studying the following claims.
Filing Document | Filing Date | Country | Kind |
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PCT/US2023/018117 | 4/11/2023 | WO |
Number | Date | Country | |
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63329627 | Apr 2022 | US | |
63342653 | May 2022 | US | |
63345930 | May 2022 | US | |
63358334 | Jul 2022 | US | |
63358337 | Jul 2022 | US | |
63359262 | Jul 2022 | US | |
63388405 | Jul 2022 | US | |
63389205 | Jul 2022 | US | |
63389496 | Jul 2022 | US | |
63405173 | Sep 2022 | US | |
63416647 | Oct 2022 | US | |
63482116 | Jan 2023 | US |