LIQUID DRUG PUMPS INCLUDING USER FEEDBACK INDICATING PUMP ORIENTATION

Various exemplary liquid drug pumps including user feedback indicating pump orientation are provided. In general, a pump configured to deliver a liquid drug to a patient includes a user interface configured to indicate an orientation of the pump. The pump also includes a reservoir configured to contain the drug therein, a conduit configured to receive the drug therein from the reservoir, a needle or cannula in fluid communication with the conduit and configured to deliver the drug therethrough to a patient wearing the pump, a fluid path fluidly connecting the reservoir and the needle or cannula, and a pumping assembly configured to pump the fluid through the fluid path from the reservoir to the needle or cannula. The user interface indicating the pump's orientation allows a user of the pump to know whether or not the pump is in a desired orientation for delivery of the drug to the patient.

FIELD

The present disclosure relates generally to liquid drug pumps including user feedback indicating pump orientation.

BACKGROUND

Pharmaceutical products (including large and small molecule pharmaceuticals, hereinafter “drugs”) are administered to patients in a variety of different ways for the treatment of specific medical indications. A pump is a type of drug administration device that can administer a liquid drug to the patient. Some pumps are wearable by a patient and can include a reservoir, such as a vial or a cartridge, that contains the liquid drug therein for delivery to the patient through a needle inserted into the patient.

The drug can be removed from the reservoir through a conduit and delivered to the patient through the needle. However, if the conduit is not in complete communication with the liquid drug in the reservoir, air can enter the conduit with the drug or instead of the drug. Air is undesirable to deliver to the patient because of, e.g., patient discomfort. If the conduit is not in complete communication with the liquid drug in the reservoir, the patient's desired treatment is interrupted by the pump delivering only air to the patient instead of the drug, by the pump delivering air to the patient with only a partial intended dose of the drug, or by the pump not delivering any air or any drug to the patient due to a detected error of air entering the conduit from the reservoir. Interrupting the patient's treatment may adversely affect the patient's health and may cause patient frustration with the pump and thereby reduce the patient's willingness to use the pump in the future as recommended by the patient's health care provider.

The conduit may not be in complete communication with the liquid drug in the reservoir for a variety of reasons. For example, the conduit may not be in complete communication with the liquid drug in the reservoir due to the patient's orientation when the drug is being pumped out of the reservoir and into the patient via the needle. Liquid in the reservoir naturally settles at a location therein due to gravity, so depending on the patient's orientation, the liquid drug may not settle within the reservoir at a location where the conduit is in complete communication with the liquid drug. Additionally, for pumps that deliver multiple doses of the drug over time, it becomes more likely over time that the patient's orientation will adversely affect the conduit's accessibility of the drug within the reservoir. As the amount of the drug in the reservoir decreases, there is less drug present in the reservoir to be in complete communication with the conduit.

For another example, the conduit may not be in complete communication with the liquid drug in the reservoir due to the pump not being positioned properly on the patient. The pump will typically come with instructions indicating how the pump should be attached to the patient, including a recommended orientation of the pump relative to the patient. The recommended orientation may help maximize the conduit's ability to be in complete communication with the drug in the reservoir for every delivery of the drug to the patient. However, the pump may not be attached to the patient at the recommended orientation due to unintentional user error.

Accordingly, there remains a need for pumps with improved liquid drug accessibility.

SUMMARY

In general, liquid drug pumps including user feedback indicating pump orientation are provided.

In one aspect, a pump configured to deliver a liquid drug to a patient is provided that in one embodiment includes a reservoir configured to contain the liquid drug therein, a pumping assembly configured to drive the liquid drug from the reservoir for delivery to the patient, a sensor configured to measure an orientation of the pump, a user interface, and control circuitry configured to receive data from the sensor indicative of the measured orientation of the pump and to cause the user interface to provide an indication of the orientation of the pump to a user of the pump. The pump can vary in any number of ways.

In another embodiment, a pump configured to deliver a liquid drug to a patient includes a housing. The housing includes a first side configured to be attached to skin of a patient at a recommended orientation relative to the patient. The pump also includes a reservoir in the housing. The reservoir is configured to contain the liquid drug therein. The pump also includes a pumping assembly in the housing. The pumping assembly is configured to drive the liquid drug from the reservoir for delivery to the patient. The pump also includes a sensor in the housing. The sensor is configured to measure an orientation of the pump. The pump also includes a user interface located on a second side of the housing. The user interface is configured to be visible by the patient with the first side of the housing attached to the skin of the patient. The pump can vary in any number of ways.

In another aspect, a method of using a pump configured to deliver a liquid drug to a patient is provided and in one embodiment includes control circuitry of the pump receiving data from a sensor of the pump as a series of real time pump orientation measurements, and the control circuitry causing a user interface of the pump to provide an indication of the orientation of the pump as a series of real time indications that each correspond to one of the real time pump orientation measurements. The method can have any number of variations.

DETAILED DESCRIPTION

Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. A person skilled in the art will appreciate that a dimension may not be a precise value but nevertheless be considered to be at about that value due to any number of factors such as manufacturing tolerances and sensitivity of measurement equipment. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the size and shape of components with which the systems and devices will be used.

Various exemplary liquid drug pumps including user feedback indicating pump orientation are provided. In general, a pump configured to deliver a liquid drug to a patient includes a user interface configured to indicate an orientation of the pump. The pump also includes a reservoir configured to contain the liquid drug therein, a conduit configured to receive the drug therein from the reservoir, a needle or cannula in fluid communication with the conduit and configured to deliver the drug therethrough to a patient wearing the pump, a fluid path fluidly connecting the reservoir and the needle or cannula, and a pumping assembly configured to pump the fluid through the fluid path from the reservoir to the needle or cannula. The user interface indicating the pump's orientation allows a user (e.g., the patient, the patient's care giver, the patient's doctor, etc.) of the pump to know whether or not the pump is in a desired orientation for delivery of the drug to the patient. The user may therefore be informed as to whether the patient's body and/or the pump should be reoriented until the pump is in a desired orientation for delivery of the drug to the patient. The desired orientation corresponds to an orientation of the pump relative to gravity, e.g., the ground, at which the liquid drug can be pumped out of the reservoir and into the conduit without any air entering the conduit from the reservoir. The user interface is thus configured to help ensure that the user begins the drug delivery process, e.g., by pressing a start button on the pump or otherwise triggering drug delivery, when the pump is oriented such that the conduit receives therein only drug from the reservoir for delivery to the patient and that the conduit does not receive therein any air contained in the reservoir. The patient may thereby be ensured to receive only drug through the needle or cannula and not any air through the needle or cannula, and the patient's drug dose(s) can therefore be fully delivered at a desired schedule without interruption since drug, and not any air, will be provided to the needle or cannula via the conduit.

The drug to be delivered using a pump as described herein can be any of a variety of drugs. Examples of drugs that can be delivered using a pump as described herein include antibodies (such as monoclonal antibodies), hormones, antitoxins, substances for the control of pain, substances for the control of thrombosis, substances for the control of infection, peptides, proteins, human insulin or a human insulin analogue or derivative, polysaccharide, DNA, RNA, enzymes, oligonucleotides, antiallergics, antihistamines, anti-inflammatories, corticosteroids, disease modifying anti-rheumatic drugs, erythropoietin, and vaccines.

The user feedback described herein can be used with a variety of drug delivery pumps configured to deliver a drug to a patient. Examples of drug delivery pumps include the pumps described in Intl. Pat. Pub. WO 2018/096534 entitled “Apparatus For Delivering A Therapeutic Substance” published May 31, 2018, in U.S. Pat. Pub. No. 2019/0134295 entitled “Local Disinfection For Prefilled Drug Delivery System” published May 9, 2019, in U.S. Pat. No. 7,976,505 entitled “Disposable Infusion Device Negative Pressure Filling Apparatus And Method” issued Jul. 12, 2011, and in U.S. Pat. No. 7,815,609 entitled “Disposable Infusion Device Positive Pressure Filling Apparatus And Method” issued Oct. 19, 2010, which are hereby incorporated by reference in their entireties. Other examples of drug delivery pumps include the SmartDose® Drug Delivery Platform available from West Pharmaceutical Services, Inc. of Exton, Pa., the OMNIPOD® available from Insulet Corp. of Acton, Mass., the YpsoDose® patch injector available from Ypsomed AG of Burgdorf, Switzerland, the BD Libertas™ wearable injector available from Becton, Dickinson and Co. of Franklin Lakes, N.J., the Sorrel Medical pump available from Sorrel Medical of Netanya, Israel, the SteadyMed PatchPump® available from SteadyMed Ltd. of Rehovot, Israel, the Sensile Medical infusion pump available from Sensile Medical AG of Olten, Switzerland, the SonceBoz wearable injectors available from SonceBoz SA of Sonceboz-Sombeval, Switzerland, enFuse® available from Enable Injections of Cincinnati, Ohio, the on-body injector for Neulasta® available from Amgen, Inc. of Thousand Oaks, Calif., the Pushtronex® System available from Amgen, Inc. of Thousand Oaks, Calif., and the Imperium® pump available from Unilife Corp. of King of Prussia, Pa.

FIG.1illustrates an embodiment of a pump20, e.g., a patch pump, configured to be worn by a patient and to deliver a drug (also referred to herein as a “therapeutic substance”)22to the patient. The pump20can be configured to be attached to the patient in any of a variety of ways, as will be appreciated by a person skilled in the art, such as by including a backing or label configured to be removed from a body of the pump20to expose adhesive attachable to the patient. The pump20includes a therapeutic substance reservoir24containing the drug22therein. The reservoir24can be prefilled by a medical vendor or device manufacturer, or the reservoir24can be filled by a user (e.g., the patient, the patient's caregiver, a doctor or other health care professional, a pharmacist, etc.) prior to use of the pump20. Alternatively, the reservoir24can come prefilled from a medical vendor ready to be loaded or inserted into pump20prior to use. The pump20also includes a conduit38through which the drug22is configured to pass from the reservoir24and into an inlet fluid path30operatively connected to an injector assembly46of the pump20that is configured to deliver the therapeutic substance22into a patient. The conduit38is thus a tube in which the drug22can flow.

The pump20also includes a user interface40configured to indicate an orientation of the pump20to a user of the pump20, e.g., the patient wearing the pump20by having the pump removably attached thereto using adhesive or other attachment mechanism, the patient's care giver assisting the patient in using the pump20, a health care professional assisting the patient in using the pump20, etc. The user interface40can have a variety of configurations, as discussed further below. The user interface40indicating the orientation of the pump20helps ensure that the conduit38is in complete communication with the drug22in the reservoir24at least when the conduit38is receiving the drug22therein from the reservoir24, e.g., under force of an electromechanical pumping assembly26of the pump20, regardless of an orientation of the patient wearing the pump20, e.g., regardless of whether the patient is standing, sitting, lying down, bent over, etc. The user interface40may therefore be configured to help ensure that the drug22, but not air, enters the conduit38from the reservoir24.FIG.1shows the conduit38in complete communication with the drug22in the reservoir24.

The pump20also includes a sensor50configured to monitor an orientation of the pump20relative to gravity, e.g., the ground. Examples of the sensor50configured to monitor orientation include an accelerometer, an inertial measurement unit (IMU), and a MARG (magnetic, angular rate, and gravity) sensor. In an exemplary embodiment the sensor50is a single sensor, which may help reduce cost of the pump20, help conserve space within the pump20for other components, and/or help reduce an overall size of the pump20. The sensor50can, however, include a plurality of sensors, which may help provide redundancy and allow for orientation measurements to be confirmed with one another for accuracy.

The electromechanical pumping assembly26, e.g., a motor thereof, is operatively connected to the reservoir24and is configured to cause delivery of the therapeutic substance22to the patient via the injector assembly46, e.g., through a needle or cannula of the injector assembly46that has been inserted into the patient. The electromechanical pumping assembly26is shaped to define a rigid pump chamber28that includes a therapeutic substance inlet30through which the therapeutic substance22is received from the conduit30, and hence from the reservoir24, into the pump chamber28. The rigid pump chamber28also includes a fluid path outlet32through which the therapeutic substance22is delivered from the pump chamber28to the patient via the injector assembly46. Although the pumping assembly26is electromechanical in this illustrated embodiment, the pumping assembly of the pump20(and for other embodiments of pumps described herein) can instead be mechanical. The mechanical pumping assembly need not include any electronic components or controls. For example, the mechanical pumping assembly can include a balloon diaphragm configured to be activated to cause delivery of a drug through mechanical action.

The pump20also includes a plunger34slidably disposed within the pump chamber28and sealably contacting an inside of the pump chamber28. The plunger34is configured to be in direct contact with the drug22in the pumping chamber28.

The pump20also includes control circuitry36. The control circuitry36is operatively connected to the sensor50and is configured to receive measurement data from the sensor50, e.g., to receive a signal from the sensor50indicative of a sensed orientation. The control circuitry36is also operatively connected to the user interface40and is configured to cause the user interface40to provide information to the user indicating the orientation of the pump20based on the pump's orientation as measured by the sensor50. The control circuitry36is configured to receive data from the sensor50in real time with the sensor's sensing and to cause pump orientation information to be provided via the user interface40in real time such that the user interface40indicates a current orientation state of the pump20.

The electromechanical pumping assembly26is configured to be driven to operate in two pumping phases by the control circuitry36. In a first pumping phase, the control circuitry36is configured to drive the plunger34(e.g., slidably move the plunger34in the pump chamber28) to draw the drug22from the reservoir24into the conduit38, then into the inlet fluid path30, and then through an inlet valve42and into the pump chamber28. The inlet valve42is configured to be opened and closed such that when the inlet valve42is open there is fluid communication between the reservoir24and the pump chamber28, and when the inlet valve42is closed there is no fluid communication between the reservoir24and the pump chamber28. During the first pumping phase, the control circuitry36is configured to cause the inlet valve42to open, cause an outlet valve44to close, and drive the plunger34to draw the therapeutic substance22from the reservoir24into the pump chamber28, e.g., the control circuitry36is configured to set the inlet valve42and the outlet valve44such that the therapeutic substance22can flow only between the reservoir24and the pump chamber28. Thus, as the plunger34is drawn back, the therapeutic substance22is drawn into pump chamber28. The control circuitry36causing the inlet valve42to open and the outlet valve44to close can be active control or can be passive control in which the valves42,44are mechanical valves that automatically open/close due to the driving of the plunger34.

In a second pumping phase, the control circuitry36is configured to drive the plunger34to deliver the drug22from the pump chamber28through the outlet valve44to the outlet fluid path32and then to the injector assembly46for delivery into the patient. The outlet valve44is configured to be opened and closed such that when the outlet valve44is open there is fluid communication between the pump chamber28and the patient, and when the outlet valve44is closed there is no fluid communication between the pump chamber28and the patient. During the second pumping phase, the control circuitry36is configured to cause the inlet valve42to close, cause the outlet valve44to open, and drive the plunger34to deliver the therapeutic substance22from the pump chamber28in a plurality of discrete motions of the plunger34. For example, the control circuitry36can be configured to set the inlet valve42and the outlet valve44such that the therapeutic substance22can flow only between the pump chamber28and the patient, and the plunger34is incrementally pushed back into the pump chamber28in a plurality of discrete motions thereby delivering the therapeutic substance22to the patient in a plurality of discrete dosages. Similar to that discussed above, the control circuitry36causing the inlet valve42to close and the outlet valve44to open can be active control or can be passive control in which the valves42,44are mechanical valves that automatically open/close due to the driving of the plunger34.

In some embodiments, the control circuitry36is configured to drive the plunger34to draw the therapeutic substance22into the pump chamber28in a single motion of the plunger34, e.g., the plunger34is pulled back in a single motion to draw a volume of the therapeutic substance22into the pump chamber28during the first pumping phase. Alternatively, the control circuitry36can be configured to drive the plunger34to draw the therapeutic substance22into the pump chamber28in one or more discrete expansion motions of the plunger34, e.g., the plunger34can be pulled halfway out of the pump chamber28in one motion and then the rest of the way out of the pump chamber28in a second, separate motion. In this case, a duration of some or all expansion motions of the plunger34during the first pumping phase are typically longer than a duration of any one of the plurality of discrete motions of the plunger34during the second pumping phase.

In other embodiments, the control circuitry36is configured to drive the plunger34such that a duration of the first pumping phase and a duration of the second pumping phase are unequal. For example, a duration of the second pumping phase can be in a range of five to fifty times longer than the first pumping phase, e.g., at least ten times, thirty times, fifty times, etc. longer than a duration of the first pumping phase.

The pump20can also include a power supply (not shown) configured to provide power to components requiring power to operate, such as the control circuitry36and the sensor50. In an exemplary embodiment, the power supply is a single power supply configured to provide power to each component of the pump20requiring power to operate, which may help reduce cost of the pump20, help conserve space within the pump20for other components, and/or help reduce an overall size of the pump20. The power supply can, however, include a plurality of power supplies, which may help provide redundancy and/or help reduce cost of the pump20since some components, e.g., the control circuitry36and/or the sensor50, may be manufactured with an on-board dedicated power supply. In an exemplary embodiment, the power supply is on-board the pump20, which may facilitate use of the pump20at any time in any location. In other embodiments, the power supply can include a mechanism configured to connect the pump20to an external power supply.

The control circuitry36is configured to determine whether the pump20is at an orientation, as indicated by the pump's current orientation as measured by the sensor50, within a predefined range of predetermined acceptable orientations. The range of predetermined acceptable orientations is defined by an area of accessibility for the conduit38being in complete communication with the drug22in the reservoir24. The range of predetermined acceptable orientations is stored in a memory of the control circuitry36for operative access by a processor of the control circuitry36.

FIG.2illustrates an area54of accessibility for the conduit38being in complete communication with the drug22in the reservoir24. The reservoir24in an exemplary embodiment and as shown inFIG.2is a vial, but the reservoir24can have other forms, as will be appreciated by a person skilled in the art, such as a cartridge. The area54has a cone shape, in particular a right circular cone shape, with the conduit38extending along a central axis of the cone along a height of the cone. An angle α of the cone's apex to a point along the cone's circular base perimeter is about 30°. With the reservoir24oriented anywhere within the area54of accessibility, the conduit38can access about 99% of the drug22contained in the reservoir24with the pump20in the predefined range of predetermined acceptable orientations. A person skilled in the art will appreciate that a value may not be precisely equal to a value but nevertheless be considered to be about that value due to any number of factors, such as manufacturing tolerance and sensitivity of measurement equipment.

FIG.3illustrates ten possible relative positions A-J of the drug22and the conduit38in the reservoir24. The reservoir24in an exemplary embodiment and as shown inFIG.3is a vial, but the reservoir24can have other forms, as will be appreciated by a person skilled in the art, such as a cartridge. A direction of gravity g is shown by arrow52. Position A corresponds to the position of the drug22and the conduit38in the reservoir24with the pump20attached to the patient in accordance with the pump's provided instructions and with the patient standing or sitting upright, e.g., with the patient vertical. Position A is shown inFIG.1. Position J corresponds to the position of the drug22and the conduit38in the reservoir24with the pump20attached to the patient in accordance with the pump's provided instructions and with the patient lying down, e.g., with the patient horizontal. Positions A-J are sequential positions as the patient moves from standing or sitting upright to lying down. Additional relative positions of the drug22and the conduit38in the reservoir24are possible between each of the illustrated ten positions A-J, and relative positions are also possible about other axes than the one illustrated inFIG.3, but are not shown for ease of illustration and discussion. In each of positions A-H, the conduit38is in complete communication with the drug22, as indicated by a check mark next to each of positions A-H. In each of positions I and J, the conduit38is not in complete communication with the drug22, as indicated by an “x” next to each of positions I and J. The conduit38is not in complete communication with the drug22in positions I and J due to the pump's orientation relative to gravity g with the liquid drug22having settled in the reservoir24in response to gravity g.

Referring again toFIG.1, the pump20can include a grip feature configured to communicate a preferred manual handling of the pump20to encourage attachment of the pump20to the patient at a recommended orientation relative to the patient. The grip feature encourages the patient to hold the pump20in a certain way by hand and thereby encourages the pump20to be held at an orientation at which the pump20can be effectively adhered to the patient at the recommended orientation. The grip feature is therefore configured to cooperate with the user interface40to encourage proper orientation of the pump20for drug delivery. Examples of the grip feature include one or more finger rests, a thumb rest, and a palm rest. The pump20can include any number of grip features, e.g., all of finger rest(s), a thumb rest, and a palm rest, two of finger rest(s), a thumb rest, and a palm rest, or only one of finger rest(s), a thumb rest, and a palm rest.

The pump20can include branding, e.g., a brand name of the pump20and/or a brand name of the drug22, on an outer surface of a housing of the pump20. The branding can be provided on the body in any of a variety of ways, such as by being printed on the housing, being on a sticker adhered to the housing, being etched into the housing, etc. In an exemplary embodiment, the branding is located on a side of the housing that is visible to and readable right-side-up by the patient when the pump20is attached to the patient at a recommended orientation relative to the patient. The branding thereby encourages attachment of the pump20to the patient at the recommended orientation relative to the patient since a user will tend to attach the pump20with the branding being readable right-side-up by the patient. The branding is therefore configured to cooperate with the user interface40(and the grip feature, if present) to encourage proper orientation of the pump20for drug delivery.

The user interface40can have a variety of configurations. In an exemplary embodiment, the user interface40includes a light, e.g., a light emitting diode (LED) or other type of light, configured to illuminate to provide an indication of the pump's orientation.

In some embodiments, the light is a single light. The single light can be located on the pump20at a location where the light would be visible to the patient wearing the pump20when the pump20is attached to the patient in accordance with the pump's instructions indicating how the pump should be attached to the patient, including a recommended orientation of the pump20relative to the patient. The single light can be configured to be illuminated, as controlled by the control circuitry36, when the pump20is determined to be within the predefined range of predetermined acceptable orientations, and to not be illuminated, as controlled by the control circuitry36, when the pump20is determined to not be within the predefined range of predetermined acceptable orientations. The user can therefore be informed whether or not the pump20is in an acceptable orientation for drug delivery by the light either being on (indicating an acceptable orientation for drug delivery) or off (indicating an unacceptable orientation for drug delivery). The user may therefore know to reorient the patient's body, and hence the orientation of the pump20, until the light is illuminated. Alternatively, the single light can be configured to be a first color, as controlled by the control circuitry36, when the pump20is determined to be within the predefined range of predetermined acceptable orientations, and to be a second, different color, as controlled by the control circuitry36, when the pump20is determined to not be within the predefined range of predetermined acceptable orientations. The user can therefore be informed whether or not the pump20is in an acceptable orientation for drug delivery by the light either being the first color (indicating an acceptable orientation for drug delivery) or the second color (indicating an unacceptable orientation for drug delivery). In an exemplary embodiment, green can be the first color as a typically identifiable “start” or “go” color, and the second color can be red as a typically identifiable “stop” color.

In other embodiments, the light is a plurality of lights. In such embodiments, the plurality of lights can be configured similar to the single light either by all being illuminated or all being in a first color to indicate the pump20being within the predefined range of predetermined acceptable orientations or by all not being illuminated or all being in a second color to indicate the pump20not being within the predefined range of predetermined acceptable orientations. Alternatively, the plurality of lights can be configured as an electronic level with the plurality of lights arranged in a line, such as by using an LED strip. A center one (or ones) of the line of lights can be configured to be illuminated with a remainder of the lights not being illuminated (or illuminated in a different color than the center one(s)), as controlled by the control circuitry36, when the pump20is determined to be within the predefined range of predetermined acceptable orientations, and for left or right ones of the lights to be illuminated, as controlled by the control circuitry36, when the pump20is determined to not be within the predefined range of predetermined acceptable orientations either by being oriented too far left (left light(s) illuminated) or too far right (right light(s) illuminated). The electronic level can thus be configured to inform the user of whether or not the pump20is in an acceptable orientation for drug delivery in addition to indicating which direction the pump20should be moved in order to move the pump20from an unacceptable orientation for drug delivery to an acceptable orientation for drug delivery. The electronic level defined by a plurality of lights can have configuration other than a line of lights, such as by being a bullseye level including concentric rings, with illumination of a center-most one of the rings (or a central circle within concentric rings) being indicative of the pump20being determined to be within the predefined range of predetermined acceptable orientations with each one of the rings successively closer to the center ring (or center circle) being indicative of the pump20being determined to be closer to the predefined range of predetermined acceptable orientations.

The plurality of lights can be located on the pump20at a location where the lights would be visible to the patient wearing the pump20when the pump20is attached to the patient in accordance with the pump's instructions indicating how the pump should be attached to the patient, including a recommended orientation of the pump20relative to the patient. Providing a plurality of lights on the pump20instead of a single light allows the lights to be located on the pump20such that one or more of the lights are positioned to be visible by the patient wearing the pump20regardless of an angle at which the patient is looking at the pump20, such as by the lights being positioned around a perimeter of the pump20. The angle at which the patient is looking at the pump20can be different based on the patient's position, e.g., the patient lying on their side versus the patient standing up, the patient's head being tilted left versus being tilted right, etc. Also, if the pump20is not attached to the patient at the recommended orientation relative to the patient such that the patient's vantage point of the pump20is not the expected vantage point, at least one of the plurality of lights can still be visible to the patient.

Whether a single light or a plurality of lights, the light(s) can be arranged around a perimeter of a “start” button of the pump20that is configured to be depressed by a user to begin drug delivery from the pump20. The user may therefore be less likely to not see the light(s) before beginning drug delivery since the light(s) are located next to the “start” button that the user will tend to look at when pushing the “start” button.

Whether a single light or a plurality of lights, the light(s) can, in some embodiments, be configured to illuminate a symbol indicative of the pump's orientation, such as a positive symbol (e.g., a plus sign, a smiling face, a check mark, etc.) indicative of the pump20being determined to be within the predefined range of predetermined acceptable orientations or a negative symbol (e.g., a minus sign, a frowning face, an “X,” etc.) indicative of the pump20being determined to not be within the predefined range of predetermined acceptable orientations. The pump20can include both the positive and negative symbols available for illumination or only one of the positive and negative symbols, which may help conserve power and/or help conserve space on the pump20. In embodiments including a plurality of lights, there can be more than just the positive and negative symbols available for illumination. For example, a neutral face can be provided in addition to a smiling face and a frowning face, with illumination of the neutral face being indicative of the pump20being closer to an acceptable orientation than an unacceptable orientation. The user may therefore be informed that a direction in which the pump20is being moved is moving the pump20closer to the desired orientation by the frowning face ceasing to be illuminated and the neutral face becoming illuminated, or, conversely, that a direction in which the pump20is being moved is moving the pump20farther from the desired orientation by the neutral face ceasing to be illuminated and the frowning face becoming illuminated.

In some embodiments, whether a single light or a plurality of lights, the control circuitry36can be configured to turn off the light(s) in response to the start of drug delivery, e.g., in response to a “start” button being pushed on the pump20, since the pump20is at the desired orientation. In other embodiments, whether a single light or a plurality of lights, the control circuitry36can be configured to turn off the light(s) in response to the end of drug delivery, which allows the user interface40to continue to indicate the pump's orientation during drug delivery so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation until drug delivery is complete. During the drug delivery, the control circuitry36can be configured to cause the light(s) to communicate information in addition to or instead of pump20orientation information, such as drug delivery progress information. For example, the control circuitry36can be configured to cause the light(s) to blink during drug delivery and to stop blinking and not be illuminated when drug delivery has completed. In other embodiments, whether a single light or a plurality of lights, the control circuitry36can be configured to turn off the light(s) in response to the end of the first pumping phase of the pumping assembly26, which allows the user interface40to continue to indicate the pump's orientation during the first pumping phase so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation throughout the first pumping phase. As discussed above, the drug22moves from the reservoir24to the pump chamber28in the first pumping phase, while in the second pumping phase the drug22moves from the pump chamber28to the injector assembly46for delivery into the patient. In general, orientation of the pump20is more critical during the first pumping phase than during the second pumping phase since during the first pumping phase the conduit38needs to be in communication with the drug22in the reservoir24so the drug22, but not air, enters the conduit38from the reservoir24.

In another exemplary embodiment, the user interface40includes a vibrating mechanism configured to vibrate to indicate the pump's orientation. The vibration is configured to be felt by the patient wearing the pump20. For example, the pump20can be configured to not provide any vibration signal (e.g., to not vibrate) until the pump20is determined to be within the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to cause the vibrating mechanism to vibrate. For another example, the pump20can be configured to provide vibration via the vibrating mechanism until the pump20is determined to be within the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to stop the vibration of the vibrating mechanism. For yet another example, the pump20can be configured to provide a first type of vibration (e.g., a slow vibration) until the pump20is determined to be within the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to cause a second, different type of vibration (e.g., a faster vibration). For still another example, the vibrating mechanism can be configured as an electronic level with vibration of the vibrating mechanism being greater the farther the pump20is from the predefined range of predetermined acceptable orientations and the vibrating mechanism not vibrating when the pump20is determined to be within the predefined range of predetermined acceptable orientations. For another example, the pump20can be configured to not provide any vibration signal (e.g., to not vibrate) until the pump20is determined to be within a predetermined amount away from the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to cause the vibrating mechanism to vibrate as a pre-notification of impending acceptable orientation.

In some embodiments in which the vibrating mechanism is configured to vibrate to indicate the pump20being determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to stop the vibration in response to the start of drug delivery, e.g., in response to a “start” button being pushed on the pump20, since the pump20is at the desired orientation and so the vibration does not interfere with drug delivery. In other embodiments in which the vibrating mechanism is configured to vibrate to indicate the pump20being determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to turn off the vibrating mechanism in response to the end of drug delivery, which allows the user interface40to continue to indicate the pump's orientation during drug delivery so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation until drug delivery is complete. In other embodiments in which the vibrating mechanism is configured to vibrate to indicate the pump20being determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to turn off the vibrating mechanism in response to the end of the first pumping phase of the pumping assembly26, which allows the user interface40to continue to indicate the pump's orientation during the first pumping phase so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation throughout the first pumping phase.

In another exemplary embodiment, the user interface40includes a speaker configured to provide an audio signal to provide an indication of the pump's orientation. The audio signal can be a single sound or a series of sounds. The sound(s) can be preprogrammed into the pump20, e.g., into a memory of the control circuitry36, and/or the sound(s) can be uploaded to the pump20by a user using a communication interface of the pump's control circuitry36that is configured to communicate (wired or wirelessly) with a device external to the pump20. For example, the pump20can be configured to not provide any audio signal until the pump20is determined to be within the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to cause an audio signal to be emitted from the speaker. For another example, the pump20can be configured to provide an audio signal until the pump20is determined to be within the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to stop the sound (or series of sounds) from being emitted from the speaker. For yet another example, the pump20can be configured to provide a first type of audio signal (e.g., a sound or series of sounds having a first tone) until the pump20is determined to be within the predefined range of predetermined acceptable orientations, at which time the control circuitry36is configured to cause a second, different type of audio signal (e.g., a sound or series of sounds having a second tone) to be emitted from the speaker. For still another example, the audio signal can be configured as an electronic level with the audio signal being louder the farther the pump20is from the predefined range of predetermined acceptable orientations and no audio signal being provided when the pump20is determined to be within the predefined range of predetermined acceptable orientations.

In some embodiments in which an audio signal is provided to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to stop the audio signal in response to the start of drug delivery, e.g., in response to a “start” button being pushed on the pump20, since the pump20is at the desired orientation. In other embodiments in which an audio signal is provided to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to turn off the audio signal in response to the end of drug delivery, which allows the user interface40to continue to indicate the pump's orientation during drug delivery so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation until drug delivery is complete. During the drug delivery, the control circuitry36can be configured to cause the speaker to communicate information in addition to or instead of pump20orientation information, such as drug delivery progress information. For example, the control circuitry36can be configured to cause the audio signal to be continuous to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations and to be a sequential series of noises during drug delivery and to stop altogether when drug delivery has completed. In other embodiments in which an audio signal is provided to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to turn off the audio signal in response to the end of the first pumping phase of the pumping assembly26, which allows the user interface40to continue to indicate the pump's orientation during the first pumping phase so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation throughout the first pumping phase.

In another exemplary embodiment, the user interface40includes a display configured to show thereon an indication of the pump's orientation. The display can include a display screen having any of a variety of configurations, such as a cathode ray tube (CRT), a liquid crystal display (LCD), a touchscreen, etc. For example, text shown on the display can indicate whether or not the pump20is determined to be within the predefined range of predetermined acceptable orientations. For another example, similar to the light(s) discussed above, colors and/or symbols shown on the display can indicate whether or not the pump20is determined to be within the predefined range of predetermined acceptable orientations. For yet another example, a digital level shown on the display, similar to the electronic level of lights discussed above, can indicate whether or not the pump20is determined to be within the predefined range of predetermined acceptable orientations.

The display can be located on a same side of the pump20as a “start” button of the pump20that is configured to be depressed by a user to begin drug delivery from the pump20. The user may therefore be less likely to not see information shown on the display before beginning drug delivery since the display is located on a side of the pump20that the user will tend to look at when pushing the “start” button.

In some embodiments in which a display is provided to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to stop providing pump20orientation information via the display in response to the start of drug delivery, e.g., in response to a “start” button being pushed on the pump20, since the pump20is at the desired orientation. In other embodiments in which a display is provided to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to stop providing pump20orientation information via the display in response to the end of drug delivery, which allows the user interface40to continue to indicate the pump's orientation during drug delivery so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation until drug delivery is complete. During the drug delivery, the control circuitry36can be configured to cause the display to communicate information in addition to or instead of pump20orientation information, such as drug delivery progress information. For example, the control circuitry36can be configured to cause the display to show information indicating that drug delivery is occurring and/or to show a progress bar indicating progress of the drug delivery. In other embodiments in which a display is provided to indicate that the pump20is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry36can be configured to stop providing pump20orientation information via the display in response to the end of the first pumping phase of the pumping assembly26, which allows the user interface40to continue to indicate the pump's orientation during the first pumping phase so the user can use the orientation information provided via the user interface40to maintain the pump20at the desired orientation throughout the first pumping phase.

In another exemplary embodiment, the user interface40includes a mechanical level configured to indicate the pump's orientation. The mechanical level does not require power to operate and may therefore always be functional and may allow a smaller and/or less powerful power supply to be used with the pump20. The mechanical level is configured and used similar to the electronic level discussed above but is implemented mechanically, e.g., using one bubble in a container filled with a liquid. The bubble is visible through a transparent or semi-transparent wall of the container. The pump20being at the desired orientation for drug delivery corresponds to the bubble being aligned with a marker on the container. Mechanical levels are familiar to many people, so the mechanical level may thus be easy for the user to understand. In an exemplary embodiment, the mechanical level is a single mechanical level, which may help reduce cost of the pump20.

The pump20can include a single type of user interface40, such as only including a light as the user interface40, only including a vibrating mechanism as the user interface40, only including a speaker as the user interface40, only including a display as the user interface40, or only including a mechanical level as the user interface40. Alternatively, the pump20can include more than one type of user interface40, e.g., including a light and a speaker, including a speaker and a vibrating mechanism, including a display and a speaker, including a display and a vibrating mechanism, including a light, a vibrating mechanism, and a speaker, including a mechanical level and a speaker, etc. Providing more than one type of user interface40may increase an initial cost of the pump20but may provide redundancy and thereby help save costs in the long run and/or increase the likelihood that the pump20is in an acceptable orientation for drug delivery when drug delivery begins because the user has the opportunity to observe more than one indicator of pump orientation. Some users may have difficulty observing a certain type of indicator, such as by a user being hard of hearing and thus having difficulty detecting an audio signal, a user having impaired eyesight and thus having difficulty seeing a display, or a user being colorblind and having difficulty discerning different colored lights or different colors on a display, so providing multiple types of user interfaces40may be particularly helpful for those users.

In embodiments in which the user interface40includes multiple types of user interfaces40, the pump20can be configured to allow one or more of the user interfaces40to be disabled as long as at least one other of the user interfaces40remains enabled. In this way, a user can disable user interface(s)40that would not be useful, such if a user is hard of hearing and thus would not be helped by an audio signal, a user having impaired eyesight and thus not likely or able to read a display, a user being in a dark location such as a movie theater and temporarily not wanting light(s) to illuminate, a user being in a location where sound would be distracting to others such as in a movie theater, business meeting, or school lecture and thus temporarily not wanting audio to sound, etc. User interfaces can be configured to be disabled in any of a variety of ways. For example, when at least one of the user interfaces40includes a display as a touchscreen, input to the touchscreen can select which one or more user interfaces40to disable, with the touchscreen not being an option for disabling to provide continual ability to provide touch inputs to the pump20. For another example, when at least one of the user interfaces40includes a light, the pump20can include a manually operable switch configured to allow the light to be selectively enabled for illumination and disabled for illumination. For another example, when at least one of the user interfaces40includes a speaker, the pump20can include a manually operable switch configured to allow the speaker to be selectively enabled to provide audio (unmuted) and disabled from providing audio (muted).

Regardless of the type of the user interface40and whether or not the user interface40includes one type or multiple types of user interfaces40, the user interface40can be configured to provide one or more types of information in addition to pump20orientation information. For example, the user interface40can be configured to indicate an error state of the pump20, such as low power supply, improper needle advancement into the patient, incompatible type of reservoir24loaded into the pump housing, etc. The error state can be communicated in a variety of ways depending on the type of the user interface40. For example, when the user interface40includes light(s), a particular light color and/or light pattern can be a predetermined indicator of an error state. Different light colors and/or light patterns can be indicative of different error states. For another example, when the user interface40includes a vibration mechanism, a particular vibration pattern can be a predetermined indicator of an error state. Different vibration patterns can be indicative of different error states. For yet another example, when the user interface40includes a speaker, a particular sound or series of sounds can be a predetermined indicator of an error state. Different sounds or series of sounds can be indicative of different error states. For another example, when the user interface40includes a display, text can be provided to identify an error state. Different text can be indicative of different error states. For still another example, when the user interface40includes a display, a particular symbol can be provided to identify an error state. Different symbols can be indicative of different error states. For another example, when the user interface40includes at least two types of user interfaces, different combinations of information provided by the multiple user interfaces can indicate different pump20states, such as a particular combination of light color and sound indicating a state, a particular combination of light color, vibration, and sound indicating a state, a particular combination of vibration and sound indicating a state, etc.

The various possible pump states that can be indicated by the user interface40can be provided for user reference in the pump's written instructions (in paper and/or online) and/or printed on the pump20. Examples of pump states include the pump20being ready to begin drug delivery, the pump20having completed drug delivery, the pump20needing its power supply to be replaced, all drug doses having been delivered from the reservoir24such that a new reservoir24and/or new pump20is needed for continued administration of the drug to the patient, the pump20being initially powered on, etc.

Regardless of the type of the user interface40and whether or not the user interface40includes one type or multiple types of user interfaces40, the user interface40providing an indication as to whether or not the pump20is in an acceptable orientation for drug delivery to begin allows the patient to be reoriented until the pump20is in the desired orientation for drug delivery. The patient can be reoriented by changing their position, e.g., standing, sitting, lying down on their left side, lying down on their right side, etc., with or without assistance from another person. In other words, the pump20is configured to be reoriented via patient movement, e.g., movement of the patient causes movement of the pump20. In some embodiments, the pump20can also be configured to be reoriented via movement of the pump20relative to the patient. In such embodiments, the user interface40providing an indication as to whether or not the pump20is in an acceptable orientation for drug delivery to begin allows the pump20to be reoriented relative to the patient until the pump20is in the desired orientation for drug delivery. The pump20can be configured to be reoriented via movement of the pump20relative to the patient by being releasably attachable to the patient such that the pump20can be attached to the patient, removed therefrom, and re-attached thereto any number of times until the pump20is desirably oriented.

The pump20can be configured to prevent drug delivery until the pump20is in an acceptable orientation for drug delivery to begin, which may help ensure that the drug is successfully delivered to the patient. The control circuitry36can be configured to prevent drug delivery until the control circuitry36determines that the pump20is in an acceptable orientation for drug delivery to begin. For example, the control circuitry36can be configured to not activate the pumping assembly26such as by the control circuitry36not responding to depression of a start button on the pump20, until determining that the pump20is in an acceptable orientation for drug delivery to begin. For another example, the pump20can include a switch movable between a first position, in which the pumping assembly26cannot be activated to begin drug delivery, and a second position, in which the pumping assembly26can be activated to begin drug delivery. The switch can be in the first position until the control circuitry36determines that the pump20is in an acceptable orientation for drug delivery to begin, at which time the control circuitry26can cause the switch to move from the first position to the second position.

FIG.4illustrates an embodiment of the pump20that includes a housing21and a backing or label23configured to be removed from the housing21to expose adhesive attachable to the patient. With the pump20adhered to the patient via the adhesive, the pump20is configured to be reoriented via patient movement in response to information provided via the user interface40.

FIGS.5-7illustrate an embodiment of the pump20configured to be reoriented via movement of the pump20relative to a patient wearing the pump20. The pump20includes a housing25, a housing mount27releasably attached to the housing25, and a backing or label29configured to be removed from the housing mount27to expose adhesive attachable to the patient. With the pump20adhered to the patient via the adhesive, the housing25is configured to be removed from the housing mount27adhered to the patient and reattached to the housing mount27adhered to the patient. In this way, the pump20can be reoriented relative to the patient in response to information provided via the user interface40.FIG.5illustrates the pump20prior to attachment of the pump20to the patient.FIG.6shows the housing mount27of the pump20adhered to a skin surface31of a patient and the housing25removed from the housing mount27.FIG.7shows the housing25reattached to the housing mount27at a different orientation relative to the housing mount27than in the pump's initial configuration (shown inFIG.5).

The housing mount27includes a Velcro surface27sconfigured to releasably engage a corresponding Velcro surface (obscured inFIGS.5-7) of the housing27. The Velcro surfaces allow the housing25to be reoriented relative to the housing mount27, and hence to the patient to which the housing mount27is adhered, at any selected orientation. Although Velcro is used to releasably attach the housing25and housing mount27in this illustrated embodiment, other releasable attachment mechanisms can be used, such as a magnet on a surface of one of the housing25and housing mount27and a magnetic surface on the other of the housing25and housing mount27, or a ball joint mechanism in which one of the housing25and housing mount27includes a ball and the other of the housing25and housing mount27includes a socket configured to releasably seat the ball therein.

FIGS.8-10illustrate another embodiment of a pump100configured to be worn by a patient and to deliver a drug148to the patient. The pump100ofFIGS.8-10is generally configured and used similar to the pump20ofFIG.1. The pump100is configured to engage with a prefilled therapeutic substance reservoir132. Within the pump100is a sterile fluid path122for delivering a drug148from the reservoir132to a patient wearing the pump100. The sterile fluid path122has a conduit126at an upstream end124of the sterile fluid path122and has an injection assembly (also referred to herein as an “injector assembly”)130at a downstream end128of the sterile fluid path122. The pump100also includes a user interface (UI)150configured to indicate an orientation of the pump100to a user of the pump, and a sensor152configured to monitor an orientation of the pump100relative to gravity, e.g., the ground.

The pump100and the prefilled therapeutic substance reservoir132are configured to engage with one another, such as shown by arrow133inFIG.8, e.g., the reservoir132is configured to be inserted into the pump100. When the pump100and the reservoir132are engaged with one another, such as is shown inFIG.9, a sealed disinfection chamber134is defined between the sterile fluid path122and the reservoir132. While the pump100and the reservoir132are typically sterile, the disinfection chamber134is (a) initially non-sterile, and (b) typically sealed from further bacteria or virus penetration. The conduit126is configured to be driven to penetrate the disinfection chamber134and subsequently the reservoir132when the pump100and the reservoir132are engaged with one another, such that fluid communication is established between the reservoir132and the sterile fluid path122, such as is shown inFIG.10.

The pump100includes a disinfection assembly136configured to disinfect the disinfection chamber134prior to the conduit126penetrating the disinfection chamber134and thus before the conduit126enters the reservoir132. The pump100includes control circuitry138configured to activate the disinfection assembly136, to subsequently terminate the activation of the disinfection assembly136, and to then drive the conduit126to penetrate the disinfection chamber134and subsequently the reservoir132.

Once fluid communication is established between the reservoir132and the sterile fluid path122, the control circuitry138is configured to drives a pump assembly140to draw the drug148from the reservoir132and deliver it to the patient via injection assembly130similar to that discussed above regarding the control circuitry36and the injector assembly46ofFIG.1.

The user interface150can have any of a variety of configurations, such as any one or more of the user interfaces discussed above with respect to the user interface40ofFIG.1.

FIG.11illustrates another embodiment of a pump200configured to be worn by a patient and to deliver a drug to the patient. The pump200ofFIG.11is generally configured and used similar to the pump20ofFIG.1. The pump200includes a reservoir210configured to contain a liquid drug therein to be delivered from the pump200. The pump200also includes a pumping assembly216configured to cause dispensing of the drug contained in the reservoir210so that the drug can be delivered to the patient. The pump200also includes an injector assembly that includes an infusion line212, e.g., a needle or a cannula. The drug is delivered from the reservoir210upon actuation of the pumping assembly216via the infusion line212.

The pump200also includes a user interface280configured to indicate an orientation of the pump200to a user of the pump, and a sensor282configured to monitor an orientation of the pump200relative to gravity, e.g., the ground. The user interface280can have a variety of configurations, such as any one or more of the user interfaces discussed above with respect to the user interface40ofFIG.1.

The pump200also includes control circuitry that includes a processor296and a memory297in operative communication with the processor296. Actuation of the pumping assembly216is controlled by the processor296, which is in operative communication with the pumping assembly216for controlling the pump's operation.

In at least some embodiments, the processor296is configured to be programmed by a user, e.g., the patient, a healthcare professional, etc., via the user interface280. The processor296being user-programmable enables the pump200to deliver the drug to the patient in a controlled manner specific to the patient. The user can enter parameters, such as infusion duration and delivery rate, via the user interface280, such as by the user interface280including a touchscreen configured to receive touch input thereto, the user interface280including selector button(s), and/or the user interface280including a keypad. The delivery rate can be set by the user to a constant infusion rate or as set intervals for periodic delivery, typically within pre-programmed limits. The programmed parameters for controlling the pumping assembly216are stored in and retrieved by the processor296from the memory297.

The pump200also includes a power supply295configured to provide power to any components of the pump200that require power for operation, such as the pumping assembly216, the processor296, the user interface280, and the sensor282.

The reservoir210, the pumping assembly216, the user interface280, the power supply295, the processor296, and the memory297are located within a housing (also referred to herein as a “body” of a pump)230of the pump200. The infusion line212is partially located within the housing230and extends from the housing230for penetration into the patient. The infusion line212can be fixedly positioned partially within the housing230and partially outside the housing230, as shown inFIG.11, or the infusion line212can be movable, e.g., under control of the circuitry, from an initial position entirely within the housing230to a delivery position partially within the housing230and partially outside the housing230.

In embodiments in which the user interface280is visual, e.g., by including one or more lights and/or including a display, the user interface280can be located on a portion of the housing230that is angled to facilitate the patient's visualization of the user interface280while the pump200is attached to the patient in accordance with instructions indicating how the pump200should be attached to the patient. The angled portion of the housing230that includes the user interface280thereon may also help ensure that the pump200is attached to the patient in accordance with instructions indicating how the pump200should be attached to the patient because the angled portion230being angled in a way so as to obscure some or all of the user interface280from the patient's view can serve as a clue that the pump200is not yet in its recommended attachment orientation.

FIG.12illustrates another embodiment of a pump300configured to be worn by a patient and to deliver a drug to the patient. The pump300ofFIG.12is generally configured and used similar to the pump20ofFIG.1, e.g., includes a body302, a removable backing or label304, a depressible button306, a user interface, a reservoir configured to contain a liquid drug therein to be delivered from the pump300, a pumping assembly configured to cause dispensing of the drug contained in the reservoir, an injector assembly configured to deliver the drug into the patient, a sensor configured to monitor an orientation of the pump300relative to gravity, a plunger configured to slide within the pump chamber, and control circuitry operatively connected to the sensor, the user interface, and the pumping assembly. As discussed above, the reservoir can be prefilled by a medical vendor or can be otherwise filled, and the reservoir can be preloaded into the pump300or can be loaded therein by a user. The reservoir, pumping assembly, injector assembly, sensor, plunger, and control circuitry are obscured by the body302inFIG.12.

The user interface in this illustrated embodiment includes a plurality of lights including a first light308and a second light310. The first light308is a single light extending circumferentially around an entire perimeter of the button306. The second light310is a series of lights arranged in a line. The second light310includes four lights in this illustrated embodiment but can include another plural number of lights. The first and second lights308,310are off (unilluminated) inFIG.12.

FIG.13shows the first light308on (illuminated) in a first color (e.g., green or other color) and the second light310off. The control circuitry can be configured to cause the first light308to be illuminated as inFIG.13in response to the manual removal of the backing304or after the backing304has been removed and the pump300adhered to a patient's skin. The pump300can include a sensor configured to monitor whether the backing304is on the pump300or has been removed therefrom, such as a pressure sensor configured to monitor pressure applied thereto by the backing304or a light sensor configured to monitor light received thereby with the backing304preventing the light sensor from receiving light until removal of the backing304from the housing302. The pump300can include a sensor configured to monitor whether the pump300has been adhered to the patient's skin, such as a pressure sensor configured to have pressure applied thereto by a lever or switch pushed thereagainst in response to the pump300being adhered to the patient's skin. In some embodiments, the control circuitry can be configured to cause the first light308to blink in the first color in response to the manual removal of the backing304and then be unilluminated after the pump300has been adhered to a patient's skin. Alternatively, the control circuitry can be configured to cause the first light308to be continuously illuminated in the first color in response to the manual removal of the backing304and then blink in the first color after the pump300has been adhered to a patient's skin.

FIG.14shows the first light308on in the first color and the second light310on in the first color. The control circuitry can be configured to cause the second light310to be illuminated (either continuously or blinking) during priming. The first light308is on at this time (either continuously or blinking, as discussed above). The pump300can include a speaker (obscured in the figures) configured to provide an audio signal, e.g., one beep, a series of two beeps, a series of three beeps, a musical sequence, etc., as controlled by the control circuitry, when priming has been completed and prior to needle or cannula insertion into the patient. The audio signal can thereby indicate to the user that needle or cannula insertion is imminent.

Depression of the button306is configured to start drug delivery. In an exemplary embodiment, the first and second lights308,310are configured to indicate to the user that pump300is ready to begin drug delivery by both of the first and second lights308,310being illuminated in the first color in a continuous manner. The first light308is configured to indicate an orientation of the pump300to the user as discussed above, e.g., by being illuminated when the pump300is determined by the control circuitry to be is in an acceptable orientation for drug delivery based on data from the sensor monitoring pump300orientation. The second light310is configured to indicate drug delivery progress.FIG.14illustrates the pump300in a configuration in which the first and second lights308,310are on to indicate that the pump300is ready to begin drug delivery.

FIGS.15-18indicate a progress of drug delivery as indicated by the second light310. The first light308remains in the illuminated state ofFIG.14inFIGS.15-18. The second light310acts as a countdown mechanism with lights in the series of lights being sequentially turned off as drug delivery occurs to indicate the drug delivery's progress. When drug delivery begins, e.g., when the button306is pressed, all four of the lights of the second light310are on. When drug delivery is about 25% complete, as determined by the control circuitry, an uppermost one of the light series of the second light310is turned off by the control circuitry such that three quarters of the light series is on and one quarter of the light series is off, as shown inFIG.15. When drug delivery is about 50% complete, as determined by the control circuitry, a second uppermost one310bof the light series of the second light310is turned off by the control circuitry such that half of the light series is on and half the light series is off, as shown inFIG.16. When drug delivery is about 75% complete, as determined by the control circuitry, a third uppermost one of the light series of the second light310is turned off by the control circuitry such that one quarter of the light series is on and three quarters of the light series is off, as shown inFIG.17. When drug delivery is complete, as determined by the control circuitry, the fourth one of the light series of the second light310is turned off by the control circuitry such that all of the light series is off, as shown inFIG.18.FIG.18also illustrates an audio signal being provided to also indicate that drug delivery is complete. The audio signal is one long beep in this illustrated embodiment, but another audio signal can be used to indicate end of drug delivery. In other embodiments with the second light310including a plural number of lights other than four, the lights will be sequentially turned off at different percentages of drug delivery completion.

In the event that an error occurs during drug delivery, one or both of the first and second lights308,310can be configured to indicate occurrence of the error as determined by the control circuitry according to pre-programmed instructions. Examples of errors include the orientation of the pump300changing from the acceptable orientation for drug delivery to an unacceptable orientation for drug delivery, occlusion in the drug fluid path in the pump300, power loss, etc.

In an exemplary embodiment, the second light310is configured to indicate occurrence of an error during drug delivery by changing from the first color to a second color (e.g., red or other color). Which one of the series of lights in the second light310changes from the first color to the second color indicates a general timing of when the error occurred during drug delivery. For example, if an error occurs after about 75% of drug delivery is complete but before about 50% of drug delivery has been completed, e.g., when the second light310is illuminated as shown inFIG.15, the second uppermost one310bof the light series, which is the uppermost illuminated one of the series of lights, is changed from the first color to the second color by the control circuitry, as shown inFIG.19.FIG.19also illustrates an audio signal being provided to also indicate that an error occurred. In this illustrated embodiment, the audio signal is a series of short beeps that continue until the error is corrected, but another audio signal can be used to indicate error occurrence. An example of a correctable error is the pump300being in an unacceptable orientation for drug delivery.

If an error is determined to have occurred that cannot be corrected, a so-called “fatal error,” each of the first and second lights308,310can be configured to indicate occurrence of the fatal error. Examples of fatal errors include occlusion in the drug fluid path in the pump300, no drug remaining in the reservoir and the reservoir not being configured for refill or replacement, and the pump's power supply being depleted of power. For example, as shown inFIG.20, the control circuitry can be configured to cause each of the first and second lights308,310to be in the second color in response to occurrence of a fatal error.FIG.20also illustrates an audio signal being provided to also indicate that a fatal error occurred. In this illustrated embodiment, the audio signal is continuous long beep, but another audio signal can be used to indicate fatal error occurrence.

FIG.21illustrates another embodiment of a pump400configured to be worn by a patient and to deliver a drug to the patient. The pump400ofFIG.21is generally configured and used similar to the pump20ofFIG.1, e.g., includes a body402, a removable backing or label404, a depressible button406, a user interface, a reservoir configured to contain a liquid drug therein to be delivered from the pump400, a pumping assembly configured to cause dispensing of the drug contained in the reservoir, an injector assembly configured to deliver the drug into the patient, a sensor configured to monitor an orientation of the pump400relative to gravity, a plunger configured to slide within the pump chamber, and control circuitry operatively connected to the sensor, the user interface, and the pumping assembly. As discussed above, the reservoir can be prefilled by a medical vendor or can be otherwise filled, and the reservoir can be preloaded into the pump400or can be loaded therein by a user. The reservoir, pumping assembly, injector assembly, sensor, plunger, and control circuitry are obscured by the body402inFIG.21.

The user interface in this illustrated embodiment includes a plurality of lights, namely a light408that includes a series of lights arranged circumferentially around an entire perimeter of the button406. The light408includes four lights in this illustrated embodiment but can include another plural number of lights.FIG.21shows the light408off.FIG.22shows all four lights of the light408illuminated in a first color (e.g., green or other color), having been turned on by the control circuitry in response to removal of the backing404or adherence of the pump400to the patient's skin similar to that discussed above regarding the pump300.

The control circuitry can be configured to cause the light408to be illuminated during priming. In an exemplary embodiment, each of the lights in the series of lights is illuminated sequentially around the button's perimeter during priming to indicate that priming is occurring, as shown inFIGS.23-26. As shown inFIG.27, the light408can be fully illuminated (all of the four lights on, either blinking or on continuously) to indicate completion of priming. The pump400can include a speaker (obscured in the figures) configured to provide an audio signal, e.g., one beep, a series of two beeps, a series of three beeps, a musical sequence, etc., as controlled by the control circuitry, when priming has been completed and prior to needle or cannula insertion into the patient. The audio signal can thereby indicate to the user that needle or cannula insertion is imminent.FIG.27illustrates the audio signal as a series of three short beeps.

Depression of the button406is configured to start drug delivery. The light408is configured to indicate an orientation of the pump400to the user as discussed above, e.g., by being illuminated (all lights in the series) when the pump400is determined by the control circuitry to be in an acceptable orientation for drug delivery based on data from the sensor monitoring pump400orientation.FIG.27illustrates the pump400in a configuration in which the light408indicates that the pump400is ready to begin drug delivery.

FIGS.28-31indicate a progress of drug delivery as indicated by the light408. The drug delivery progress indicated by the light408is similar to that indicated by the second light310of the pump300by acting as a countdown mechanism with the series of lights being sequentially turned off as drug delivery occurs to indicate the drug delivery's progress. When drug delivery begins, e.g., when the button406is pressed, all four of the lights of the light408are on, as shown inFIG.27. When drug delivery is about 25% complete, as determined by the control circuitry, one of the lights is turned off by the control circuitry such that three quarters of the light series is on and one quarter of the light series is off, as shown inFIG.28. A top upper right one of the lights is off in this illustrated embodiment, but another one of the lights can be the first one turned off during drug delivery. When drug delivery is about 50% complete, as determined by the control circuitry, a second one of the light series is turned off by the control circuitry such that half of the light series is on and half the light series is off, as shown inFIG.29. The lights are turned off in a clockwise manner in this illustrated embodiment, but the lights can instead be turned off in a counterclockwise manner. When drug delivery is about 75% complete, as determined by the control circuitry, a third one of the light series is turned off by the control circuitry such that one quarter of the light series is on and three quarters of the light series is off, as shown inFIG.30. When drug delivery is complete, as determined by the control circuitry, the last one of the light series is turned off by the control circuitry such that all of the light series is off, as shown inFIG.31.FIG.31also illustrates an audio signal being provided, e.g., via a speaker of the pump400as controlled by the control circuitry, to also indicate that drug delivery is complete. The audio signal is one long beep in this illustrated embodiment, but another audio signal can be used to indicate end of drug delivery. In other embodiments with the light408including a plural number of lights other than four, the lights will be sequentially turned off at different percentages of drug delivery completion.

In the event that an error occurs during drug delivery, the light408can be configured to indicate occurrence of the error. In an exemplary embodiment, the light408is configured to indicate occurrence of an error during drug delivery by at least one of the series of lights changing from the first color to a second color (e.g., red or other color). Which one of the series of lights changes from the first color to the second color indicates a general timing of when the error occurred during drug delivery. For example, if an error occurs after about 75% of drug delivery is complete but before about 50% of drug delivery has been completed, e.g., when the light408is illuminated as shown inFIG.28, the second one of the light series that would be turned off is changed from the first color to the second color by the control circuitry, as shown inFIG.32.FIG.32also illustrates an audio signal being provided to also indicate that an error occurred. In this illustrated embodiment, the audio signal is series of short beeps that continue until the error is corrected, but another audio signal can be used to indicate error occurrence.

If a fatal error is determined to have occurred, e.g., as determined by the control circuitry, the light408can be configured to indicate occurrence of the fatal error. For example, as shown inFIG.33, the control circuitry can be configured to cause the light408to be in the second color in response to occurrence of a fatal error.FIG.33also illustrates an audio signal being provided to also indicate that a fatal error occurred. In this illustrated embodiment, the audio signal is continuous long beep, but another audio signal can be used to indicate fatal error occurrence.

FIG.34illustrates another embodiment of a pump500configured to be worn by a patient and to deliver a drug to the patient. The pump500ofFIG.34is generally configured and used similar to the pump20ofFIG.1, e.g., includes a body502, a removable backing or label (obscured inFIG.34), a depressible button506, a user interface, a reservoir configured to contain a liquid drug therein to be delivered from the pump500, a pumping assembly configured to cause dispensing of the drug contained in the reservoir, an injector assembly configured to deliver the drug into the patient, a sensor configured to monitor an orientation of the pump500relative to gravity, a plunger configured to slide within the pump chamber, and control circuitry operatively connected to the sensor, the user interface, and the pumping assembly. As discussed above, the reservoir can be prefilled by a medical vendor or can be otherwise filled, and the reservoir can be preloaded into the pump500or can be loaded therein by a user. The reservoir, pumping assembly, injector assembly, sensor, plunger, and control circuitry are obscured by the body502inFIG.34.FIG.34also illustrates an embodiment of a grip feature512in the form of a finger rest indentation in the pump's housing on a side thereof next to a side of the housing that attaches to a patient.

The user interface in this illustrated embodiment includes a plurality of lights including a first light508and a second light510. The first light508is a single light extending circumferentially around an entire perimeter of the button506. The second light510is a series of lights arranged in a line. The second light510includes four lights in this illustrated embodiment but can include another plural number of lights. The first and second lights508,510are off (unilluminated) inFIG.34.

The first and second lights508,510are configured and used similar to the first and second lights308,310of the pump300except that instead of each being located on a same side of the pump's body502like the first and second lights308,310on the body302of the pump300, the first light508is located on a same side of the body502as the button506, and the second light510is located on a different side of the body502than the first light508and the button506.

FIG.35shows the first light508on (illuminated) in a first color (e.g., green or other color) and the second light510off. The control circuitry can be configured to cause the first light508to be illuminated as inFIG.35in response to the manual removal of the backing or after the backing has been removed and the pump500adhered to a patient's skin, similar to that discussed above regarding the pump300.

FIG.36shows the first light508on in the first color and the second light510on in the first color. The control circuitry can be configured to cause the second light510to be illuminated (either continuously or blinking) during priming. The first light508is on at this time (either continuously or blinking, as discussed above). The pump500can include a speaker (obscured inFIGS.34-36) configured to provide an audio signal, e.g., one beep, a series of two beeps, a series of three beeps, a musical sequence, etc., as controlled by the control circuitry, when priming has been completed and prior to needle or cannula insertion into the patient. The audio signal can thereby indicate to the user that needle or cannula insertion is imminent.

Depression of the button506is configured to start drug delivery. In an exemplary embodiment, the first and second lights508,510are configured to indicate to the user that pump500is ready to begin drug delivery by both of the first and second lights508,510being illuminated in a continuous manner. The first light508is configured to indicate an orientation of the pump500to the user as discussed above, e.g., by being illuminated when the pump500is determined by the control circuitry to be is in an acceptable orientation for drug delivery based on data from the sensor monitoring pump500orientation. The second light510is configured to indicate drug delivery progress as discussed above and as discussed further below.FIG.36illustrates the pump500in a configuration in which the first and second lights508,510indicate that the pump500is ready to begin drug delivery.

FIGS.37-40indicate a progress of drug delivery as indicated by the second light510. The first light508remains in the illuminated state ofFIG.36inFIGS.37-40. The second light510acts as a countdown mechanism with lights in the series of lights being sequentially turned off as drug delivery occurs to indicate the drug delivery's progress. When drug delivery begins, e.g., when the button506is pressed, all four of the lights of the second light510are on. When drug delivery is about 25% complete, as determined by the control circuitry, an uppermost one of the light series of the second light510is turned off by the control circuitry such that three quarters of the light series is on and one quarter of the light series is off, as shown inFIG.37. When drug delivery is about 50% complete, as determined by the control circuitry, a second one of the light series of the second light510is turned off by the control circuitry such that half of the light series is on and half the light series is off, as shown inFIG.38. When drug delivery is about 75% complete, as determined by the control circuitry, a third uppermost one of the light series of the second light510is turned off by the control circuitry such that one quarter of the light series is on and three quarters of the light series is off, as shown inFIG.39. When drug delivery is complete, as determined by the control circuitry, the fourth one of the light series of the second light510is turned off by the control circuitry such that all of the light series is off, as shown inFIG.40.FIG.40also illustrates an audio signal being provided to also indicate that drug delivery is complete. The audio signal is one long beep in this illustrated embodiment, but another audio signal can be used to indicate end of drug delivery. In other embodiments with the second light510including a plural number of lights other than four, the lights will be sequentially turned off at different percentages of drug delivery completion.

In the event that an error occurs during drug delivery, one or both of the first and second lights508,510can be configured to indicate occurrence of the error, similar to that discussed above regarding the first and second lights308,310of the pump300. In an exemplary embodiment, the second light510is configured to indicate occurrence of an error during drug delivery by changing from the first color to a second color (e.g., red or other color). Which one of the series of lights in the second light510changes from the first color to the second color indicates a general timing of when the error occurred during drug delivery. For example, if an error occurs after about 75% of drug delivery is complete but before about 50% of drug delivery has been completed, e.g., when the second light510is illuminated as shown inFIG.37, the second one of the light series, is changed from the first color to the second color by the control circuitry, as shown inFIG.41.FIG.41also illustrates an audio signal being provided to also indicate that an error occurred. In this illustrated embodiment, the audio signal is series of short beeps that continue until the error is corrected, but another audio signal can be used to indicate error occurrence. If a fatal error is determined to have occurred, e.g., as determined by the control circuitry, that cannot be corrected, a so-called “fatal error,” each of the first and second lights508,510can be configured to indicate occurrence of the fatal error. For example, as shown inFIG.42, the control circuitry can be configured to cause each of the first and second lights508,510to be in the second color in response to occurrence of a fatal error.FIG.42also illustrates an audio signal being provided to also indicate that a fatal error occurred. In this illustrated embodiment, the audio signal is continuous long beep, but another audio signal can be used to indicate fatal error occurrence.

FIG.43illustrates another embodiment of a pump600configured to be worn by a patient and to deliver a drug to the patient. The pump600ofFIG.43is generally configured and used similar to the pump400ofFIG.21except that the pump600ofFIG.43includes a sticker602that covers the pump's button604, which is surrounded by a light606similar to the light408surrounding the button406of the pump400. The sticker602is configured to be manually removed by a user to expose the button604, as shown inFIG.44. The sticker602initially being positioned over the button604may help protect the button604before use of the pump600, help protect the light606before use of the pump606, and/or help ensure that the user knows the location of the button604and the light606since the sticker602being positioned over the button604prevents depression of the button604. The sticker602is substantially rigid, e.g., made from a substantially rigid material, in at least a central portion thereof to help prevent depression of the button604until the sticker602is removed. A person skilled in the art will appreciate that an element may not be entirely rigid but nevertheless be considered to be substantially rigid due to any number of factors such as manufacturing tolerances and sensitivity of measurement equipment. The button604can be softer than the sticker602, e.g., made from a softer material than the sticker602, which may further indicate to the user that the pump600is ready for use with the sticker602removed.FIGS.43and44also illustrate an embodiment of a grip feature608in the form of a finger rest indentation in the pump's housing on a side thereof next to a side of the housing that attaches to a patient.

FIGS.45and46illustrate another embodiment of a pump700configured to be worn by a patient and to deliver a drug to the patient. The pump700ofFIGS.45and46is generally configured and used similar to the pump400ofFIG.21except that the pump700ofFIGS.45and46has a differently shaped body702than the body402of the pump400.FIGS.45and46each illustrate the pump's backing or label704on and the pump's light706off.

FIGS.47and48illustrate another embodiment of a pump800configured to be worn by a patient and to deliver a drug to the patient. The pump800ofFIGS.47and48is generally configured and used similar to the pump400ofFIG.21except that the pump800ofFIGS.47and48has a differently shaped body802than the body402of the pump400(and than the pump700ofFIGS.45and46).FIGS.47and48each illustrate the pump's backing or label804on and the pump's light806off.

FIGS.49and50illustrate another embodiment of a pump900configured to be worn by a patient and to deliver a drug to the patient. The pump900ofFIGS.49and50is generally configured and used similar to the pump400ofFIG.21except that the pump900ofFIGS.49and50has a differently shaped body802than the body402of the pump400(and than the pump700ofFIGS.45and46and the pump800ofFIGS.47and48).FIGS.49and50each illustrate the pump's backing or label904on and the pump's light906off.

The pump20ofFIG.1, the pump100ofFIGS.8-10, the pump200ofFIG.11, the pump300ofFIGS.12-20, the pump400ofFIGS.21-33, the pump500ofFIGS.34-42, the pump600ofFIGS.43-44, the pump700ofFIGS.45-46, the pump800ofFIGS.47-48, and the pump900ofFIGS.49-50each include a user interface on-board the pump that is configured to indicate an orientation of the pump to a user of the pump. In other embodiments, a user interface configured to indicate an orientation of a pump to a user of the pump can be off-board the pump but otherwise configured and used similar to the user interfaces discussed herein.FIG.51illustrates one embodiment of a system1000that includes a pump1002configured to be worn by a patient and to deliver a drug to the patient and an external device1004configured to communicate with the pump1002via a communication link1006(wired or wireless). The external device1004includes a user interface1008configured to indicate an orientation of the pump1002to a user of the pump1002. Except for the user interface1008being off-board the pump1002instead of on-board the pump1002, the pump1002ofFIG.51is generally configured and used similar to any of the pump20ofFIG.1, the pump100ofFIGS.8-10, the pump200ofFIG.11, the pump300ofFIGS.12-20, the pump400ofFIGS.21-33, the pump500ofFIGS.34-42, the pump600ofFIGS.43-44, the pump700ofFIGS.45-46, the pump800ofFIGS.47-48, and the pump900ofFIGS.49-50.

In embodiments in which a user interface configured to indicate an orientation of a pump to a user of the pump is off-board the pump, the pump's control circuitry can include a communications interface (e.g., a wireless transceiver, etc.) configured to communicate, via wired or wireless connection, measured orientation data to an external device that is off-board of the pump and that includes the user interface. In an exemplary embodiment the communication interface is configured to communicate wirelessly using any of a number of wireless techniques, e.g., Wi-Fi, Near Field communication (NFC), Bluetooth, Bluetooth Low Energy (BLE), cellular communication, etc. The external device can be any of a variety of types of computer systems, such as a desktop computer, a workstation, a minicomputer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a mobile phone, a smart watch, etc. The external device can be a personal device of the user and can be securely paired with the pump in any of a variety of ways, as will be appreciated by a person skilled in the art, to help ensure privacy and security.

The external device can have an application (also referred to herein as an “app”) installed thereon that controls the user interface that provides orientation information to the user. Data gathered by the pump's sensor can be communicated to the external device using the pump's communication interface and a corresponding communication interface of the external device that is configured to communicate with the pump's communication interface. The external device can be configured to provide orientation information as discussed herein to the user via the app, with the user interface controlled by the app including one or more of the varieties described herein, e.g., any one or more of light(s) on the external device, a vibrating mechanism, a speaker, and a display.

As discussed herein, one or more aspects or features of the subject matter described herein, for example components of the control circuitry, can be realized in digital electronic circuitry, integrated circuitry, specially designed application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) computer hardware, firmware, software, and/or combinations thereof. These various aspects or features can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

The present disclosure has been described above by way of example only within the context of the overall disclosure provided herein. It will be appreciated that modifications within the spirit and scope of the claims may be made without departing from the overall scope of the present disclosure.