US20210369981A1 - Drug delivery device with air and backflow elimination - Google Patents

Drug delivery device with air and backflow elimination Download PDF

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Publication number
US20210369981A1
US20210369981A1 US17/398,584 US202117398584A US2021369981A1 US 20210369981 A1 US20210369981 A1 US 20210369981A1 US 202117398584 A US202117398584 A US 202117398584A US 2021369981 A1 US2021369981 A1 US 2021369981A1
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Prior art keywords
delivery device
drug delivery
fluid path
wearable
flow
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US17/398,584
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Steven CARDINALI
David Nazzaro
Lawrence S. Ring
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Insulet Corp
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Insulet Corp
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Priority to US17/398,584 priority Critical patent/US20210369981A1/en
Assigned to INSULET CORPORATION reassignment INSULET CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: AMGEN, INC.
Assigned to AMGEN, INC. reassignment AMGEN, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: RING, LAWRENCE S.
Assigned to INSULET CORPORATION reassignment INSULET CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CARDINALI, STEVEN, NAZZARO, DAVID
Publication of US20210369981A1 publication Critical patent/US20210369981A1/en
Assigned to MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT reassignment MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT SECURITY AGREEMENT SUPPLEMENT FOR INTELLECTUAL PROPERTY Assignors: INSULET CORPORATION
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16813—Flow controllers by controlling the degree of opening of the flow line
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16886—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body for measuring fluid flow rate, i.e. flowmeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1402—Priming
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1406—Minimizing backflow along the delivery catheter track

Definitions

  • Embodiments generally relate to medication delivery. More particularly, embodiments relate to providing flow of a liquid drug from a drug delivery device in a manner that eliminates air entrainment and backflow.
  • FIG. 1 illustrates an exemplary drug delivery device.
  • FIG. 2 illustrates a side view of the drug delivery device of FIG. 1 .
  • FIG. 3 illustrates an exemplary system for removing air from a fluid path of the drug delivery device of FIG. 1 .
  • FIG. 4A illustrates a soft needle or cannula of the fluid path of the drug delivery device of FIG. 1 engaged with a user.
  • FIG. 4B illustrates a tip portion of the soft needle or cannula of FIG. 4A engaged with tissue of a user.
  • FIG. 4C illustrates a flow sensor system coupled to the fluid path of the drug delivery device of FIG. 1 .
  • FIG. 5 illustrates a technique for preventing coagulation of fluid within the fluid path of the drug delivery device of FIG. 1 .
  • This disclosure presents various systems, components, and methods for delivering a liquid drug or medicine to a patient or user.
  • Each of the systems, components, and methods disclosed herein provides one or more advantages over conventional systems, components, and methods.
  • Various embodiments include a wearable drug delivery device that can deliver a liquid drug stored in a container to a patient or user.
  • a soft needle or cannula can be placed in fluid communication with the liquid drug and can be coupled to a needle insertion component that provides access to the patient.
  • a drive system of the drug delivery device can expel the liquid drug from the container to the patient through the soft needle or cannula. The result is enhanced comfort of the patient when using the drug delivery device. Correct dosage to the patient can also be assured.
  • Any type of liquid drug can be stored by the drug delivery device and delivered to a patient.
  • the container can contain any therapeutic agent such as, for example, a drug, a subcutaneous injectable, a medicine, or a biologic. Other embodiments are disclosed and described.
  • FIG. 1 illustrates an exemplary embodiment of a drug delivery device 100 .
  • the drug delivery device 100 can include a top portion or cover 102 and a lower portion or base 104 .
  • the top portion 102 and the lower portion 104 can together form a housing of the drug delivery device 100 .
  • the top portion 102 and the lower portion 104 can be coupled together to form an outside of the drug delivery device 100 .
  • the top portion 102 and the lower portion 104 can be formed from any material including, for example, plastic, metal, rubber, or any combination thereof.
  • the top portion 102 of the drug delivery device 100 can include a raised portion 106 that is elongated and runs along a side of the drug delivery device 100 .
  • a liquid drug cartridge (not shown) can be approximately positioned under the raised portion 106 such that the raised portion 106 accommodates the size and positioning of a liquid drug container within the drug delivery device 100 .
  • the top portion 102 can also include a patient interaction element or component 108 .
  • the patient interaction element 108 can be a push button or other patient input device used to activate the drug delivery device 100 .
  • the drug delivery device 100 can be a wearable drug delivery device 100 .
  • the drug delivery device 100 can be part of an on-body delivery system (OBDS).
  • OBDS on-body delivery system
  • the drug delivery device 100 can be coupled to a patient using an adhesive.
  • the drug delivery device 100 can operate as a bolus drug delivery device, or as a continuous drug delivery device. In general, the drug delivery device 100 can provide any amount of a stored liquid drug to a patient over any period of time.
  • FIG. 2 illustrates a side view of the drug delivery device 100 .
  • the drug delivery device 100 can include a soft needle or cannula 110 extending from the bottom portion 104 of the drug delivery device 100 .
  • the soft needle or cannula 110 can be a portion of a needle insertion mechanism.
  • the soft needle or cannula 110 extends from the drug delivery device 100 into the patient once a hard needle of the needle insertion mechanism has been retracted back inside the drug delivery device 100 .
  • the soft needle or cannula 110 can extend below the bottom portion 104 when attached to a patient and when delivering a liquid drug to the patient.
  • the soft needle or cannula 110 can remain extended outside of the drug delivery device 100 after activation.
  • FIG. 3 illustrates a system 300 for removing air from a fluid path of the drug delivery device 100 .
  • the system 300 can include a fluid path 112 that employs air eliminating features.
  • the system 300 can be a part or component of the drug delivery device 100 .
  • the fluid path 112 can couple a reservoir 114 to a patient or user of the drug delivery device 100 .
  • the fluid path 112 can provide fluid communication between the reservoir 114 and the soft needle or cannula 110 used to provide access to the body of the user of the drug delivery device 100 .
  • the reservoir 114 can be a pre-filled cartridge.
  • the reservoir 114 can store or hold any type of liquid drug 140 .
  • the liquid drug 140 can be insulin.
  • a plunger 142 can be positioned within the reservoir 114 . The plunger 142 can be moved to expel the liquid drug 140 from the reservoir 114 —by forcing the liquid drug 140 out of the reservoir 114 , through the fluid path 112 , and on to the soft needle or cannula 110 for delivery to the user.
  • the fluid path 114 can be formed of a variety materials including, for example, plastic, metal, rubber, or any combination thereof.
  • the plunger 142 can be considered to be a pump or pumping system, or a portion thereof, for extracting the liquid drug 140 from the reservoir 114 .
  • fluid path may be any portion of a fluid path within, or outside, the drug delivery device 100 , which is employed to deliver the liquid drug 140 to a user.
  • the fluid path 112 runs from the reservoir 114 within the drug delivery device 100 to the soft needle or cannula 110 , which can be located either inside or outside the drug delivery device 100 .
  • the liquid drug 140 within the reservoir 114 and/or fluid path 112 can contain undesirable quantities of air.
  • air may be eliminated from a fluid path using a separate priming step.
  • a quantity of liquid drug from a liquid drug reservoir is ejected from the end of the drug delivery path to eliminate any air bubbles present in the fluid path.
  • Such priming may not be effective, however, at eliminating air bubbles that exist far back in the fluid path (e.g., closer to the reservoir) or within the fluid reservoir. Thus, priming can be ineffective in ensuring that all air bubbles are removed from the reservoir and fluid path.
  • the fluid path 112 can include a venting station or component 118 .
  • the venting station 118 can include an opening 144 in a wall of the fluid path 112 .
  • the opening can be blocked or covered by a membrane 116 .
  • the membrane 116 can comprise a liquid-proof and air-permeable (e.g., hydrophobic) material.
  • the membrane 116 can prevent the liquid drug 140 from passing therethrough, while allowing any air bubbles entrained in the liquid drug 140 to pass therethrough.
  • any air or air bubbles within the liquid drug 140 can pass through the membrane 116 as the liquid drug 140 traverses the venting station 118 of the fluid path 112 . In doing so, however, the liquid drug 140 is blocked from exiting the fluid path 112 and can be passed along to the soft needle or cannula 110 .
  • venting station 118 may be implemented at one or more locations along the length of the fluid path 112 .
  • a venting station 118 can be implemented directly adjacent to, or as part of, the reservoir 114 itself.
  • the discrete venting station 118 can be eliminated, and the membrane 116 can be directly attached to the fluid path 112 at one or more locations along the length thereof.
  • the membrane 116 can form a portion of the fluid path 112 (such as a portion of a wall of the fluid path 112 ).
  • relatively very small channels could be employed in the fluid path 112 itself. The channels can be sized so that they do not allow the liquid drug 140 to flow through (e.g., due to surface tension), but allow air to flow through.
  • FIGS. 4A-4C illustrate arrangements for preventing fluid from flowing back into the fluid path 112 .
  • conventional drug delivery devices can, under certain circumstances, allow fluid from the user's body to flow back into a fluid path of a drug delivery device. Backflow can cause undesirable clogging of the fluid path and/or can result in incorrect dosage of liquid drug to the patient.
  • FIG. 4A illustrates the soft needle or cannula 110 of the fluid path 112 engaged with a user.
  • FIG. 4B illustrates a tip portion 120 of the soft needle or cannula 110 engaged with tissue 122 of the user.
  • FIG. 4C illustrates a flow sensor system 402 coupled to the fluid path 112 .
  • the fluid path 112 is shown coupling the reservoir 114 to the tip portion 120 of the soft needle or cannula 110 .
  • the tip portion 120 can be engaged with the tissue 122 of a user.
  • the soft needle or cannula 110 can be part of the fluid path 112 , which itself is fluidically coupled to the reservoir 114 containing the liquid drug 140 (not shown in FIG. 4A for simplicity).
  • FIG. 4B shows a close-up view of the tip portion 120 of the soft needle or cannula 110 engaged with the tissue 122 of the user.
  • the tip portion 120 of the soft needle or cannula 110 can have a “duckbill” feature 404 attached to, or otherwise integrated into, the soft needle or cannula 110 .
  • the duckbill feature 404 can comprise an opening or slit at approximately a center of the tip portion 120 that can open or close.
  • the duckbill feature 404 can be a one-way valve that can only open with a positive pressure imposed from inside the drug delivery device 100 , which in some embodiments can be created by the plunger 142 used to dispense the liquid drug 140 .
  • the duckbill feature 404 can seal itself (as shown in FIG. 4B ) and will not allow fluid to travel back into the fluid path 112 .
  • Alternatives to the duckbill feature 404 can include the use of one or more one-way check valves (e.g., ball valves) and/or alternative tip arrangements that enable flow in one direction but prevent flow in an opposite direction (e.g., allow flow from the fluid path 112 to the tissue 122 of the user but prevent flow from the user into the fluid path 112 ).
  • one-way check valves e.g., ball valves
  • alternative tip arrangements that enable flow in one direction but prevent flow in an opposite direction (e.g., allow flow from the fluid path 112 to the tissue 122 of the user but prevent flow from the user into the fluid path 112 ).
  • FIG. 4A illustrates the flow sensor system 402 coupled to the fluid path 112 .
  • one or more flow sensor systems can be coupled to the fluid path 112 .
  • FIG. 4C shows a close-up view of the flow sensor system 402 .
  • the flow sensor system 402 can include a flow sensor 124 positioned to detect the direction of fluid flow through the fluid path 112 . If the flow sensor 124 senses that fluid is moving backwards (i.e., from the user to the reservoir 114 ), then the flow sensor system 402 can activate a “pinch point” to prevent fluid from flowing through the fluid path 112 . As shown in FIG.
  • the pinch point can include a pair of opposing clamping elements 126 a and 126 b (e.g., as part of the flow sensor system 402 ), which are positioned on opposite sides of the fluid path 112 .
  • the opposing clamping elements 126 a and 126 b can be positioned on opposite sides of the soft needle or cannula 110 .
  • the flow sensor system 402 (e.g., via a processor, a controller, or other logic) can, upon receiving signals from the flow sensor 124 indicative of flow moving backwards through the fluid path 112 , cause the clamping elements 126 a , 126 b to move toward each other sufficiently to constrict the fluid path 112 , thus preventing flow through the fluid path 112 .
  • a mechanical fluid flow detector could be employed in lieu of the flow sensor 124 .
  • a mechanical fluid flow detector may be desirable for fully-mechanical implementations of the drug delivery devices 100 .
  • FIG. 5 illustrates an arrangement and/or a technique for preventing coagulation within the fluid path 112 of the drug delivery device 100 .
  • coagulation-based clogging of a fluid path can occur when blood flows from a tissue site, back through the fluid path. If the blood is quickly expelled out through the fluid path, coagulation is not an issue. If blood is allowed to remain in the fluid path, however, coagulation can become a problem.
  • the disclosed arrangement and/or technique can include applying a slow, steady fluid flow (as indicated by flow arrows 502 ) through the fluid path 112 and out of the soft needle or cannula 110 , thus ensuring that blood will not remain in the fluid path 112 long enough to coagulate and block the fluid path.
  • a minimum flow rate of about 0.25 microliters per hour of liquid through the fluid path 112 may be employed to ensure that entrained particles 128 are always moving toward the delivery site (i.e., from the reservoir 114 toward the user) and thus cannot coagulate.
  • This flow rate can be controlled either mechanically or electronically, via the pumping arrangement of the drug delivery device 100 .
  • This minimum flow rate can be provided by a pumping mechanism (e.g., a plunger) configured to extract a fluid from the reservoir 114 .

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Abstract

A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient or user is provided. A soft needle or cannula can be placed in fluid communication with the liquid drug and can be coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the container to the patient through the soft needle or cannula. The wearable drug delivery device can include components for preventing backflow and eliminating air within the liquid drug. As a result, the comfort of the patient can be enhanced and correct drug dosages can be provided when using the drug delivery device.

Description

    CROSS REFERENCE TO RELATED APPLICATIONS
  • This application is a continuation of U.S. application Ser. No. 16/191,891, filed Nov. 15, 2018, which claims the benefit of U.S. Provisional Application No. 62/587,812, filed Nov. 17, 2017, which is incorporated herein by reference in its entirety.
    • TECHNICAL FIELD
  • Embodiments generally relate to medication delivery. More particularly, embodiments relate to providing flow of a liquid drug from a drug delivery device in a manner that eliminates air entrainment and backflow.
    • BACKGROUND
  • Many conventional drug delivery systems, such as handheld auto-injectors, are designed to rapidly deliver a drug to a patient. These conventional drug delivery systems are generally not suitable for delivering a drug to a user over relatively longer periods of time as may be required for many drugs. As an alternative to conventional auto-injectors, many conventional drug delivery systems are designed to be wearable and to deliver a drug more slowly to the patient. While these conventional wearable drug delivery devices provide advantages, they can also suffer from certain problems in operation.
  • One problem with conventional wearable drug delivery devices is that, under certain circumstances, fluid from the user's body can undesirably be forced back into the fluid path of the drug delivery device. As will be appreciated, during drug delivery using a wearable device, the device and the user's body can be part of a balanced pressure system. Thus, if the pressure in the system is disturbed, undesirable backflow can occur. This, in turn, can cause clogging of the fluid path and/or can result in incorrect dosage to the patient. The problem can be particularly acute when the backflow includes blood, which can coagulate in the fluid delivery path causing the aforementioned clogging, and which, as mentioned, can prevent delivery of the drug and/or incorrect dosage to the patient.
  • Another problem with conventional wearable drug delivery devices is that, during filling with a liquid drug, there exists the possibility that air bubbles can become trapped in the liquid drug if the user does not properly purge the air. Priming techniques may thus be employed to remove trapped air and also to fill parts of the fluid path with deliverable liquid drug. Trapped air in the fluid path can present problems because air is compressible and can create compliance within a hydraulic drug delivery system. Compliance in the system and compressibility of air due to pressure or temperature can undesirably allow interstitial pressure to migrate bodily fluids, such as blood, into the fluid path and even into the associated liquid drug reservoir. If blood is allowed to migrate into the fluid path, it can coagulate and occlude the flow path, hindering the device's ability to deliver the liquid drug in a desired controlled manner.
  • In view of the above, it would be desirable to provide a drug delivery device that prevents undesirable backflow of fluids in the drug delivery path, eliminates air from the delivered liquid drug, and ensures uninterrupted delivery of liquid drug to the user.
    • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 illustrates an exemplary drug delivery device.
  • FIG. 2 illustrates a side view of the drug delivery device of FIG. 1.
  • FIG. 3 illustrates an exemplary system for removing air from a fluid path of the drug delivery device of FIG. 1.
  • FIG. 4A illustrates a soft needle or cannula of the fluid path of the drug delivery device of FIG. 1 engaged with a user.
  • FIG. 4B illustrates a tip portion of the soft needle or cannula of FIG. 4A engaged with tissue of a user.
  • FIG. 4C illustrates a flow sensor system coupled to the fluid path of the drug delivery device of FIG. 1.
  • FIG. 5 illustrates a technique for preventing coagulation of fluid within the fluid path of the drug delivery device of FIG. 1.
    •  DETAILED DESCRIPTION
  • This disclosure presents various systems, components, and methods for delivering a liquid drug or medicine to a patient or user. Each of the systems, components, and methods disclosed herein provides one or more advantages over conventional systems, components, and methods.
  • Various embodiments include a wearable drug delivery device that can deliver a liquid drug stored in a container to a patient or user. A soft needle or cannula can be placed in fluid communication with the liquid drug and can be coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the container to the patient through the soft needle or cannula. The result is enhanced comfort of the patient when using the drug delivery device. Correct dosage to the patient can also be assured. Any type of liquid drug can be stored by the drug delivery device and delivered to a patient. In various embodiments, the container can contain any therapeutic agent such as, for example, a drug, a subcutaneous injectable, a medicine, or a biologic. Other embodiments are disclosed and described.
  • FIG. 1 illustrates an exemplary embodiment of a drug delivery device 100. The drug delivery device 100 can include a top portion or cover 102 and a lower portion or base 104. The top portion 102 and the lower portion 104 can together form a housing of the drug delivery device 100. The top portion 102 and the lower portion 104 can be coupled together to form an outside of the drug delivery device 100. The top portion 102 and the lower portion 104 can be formed from any material including, for example, plastic, metal, rubber, or any combination thereof.
  • The top portion 102 of the drug delivery device 100 can include a raised portion 106 that is elongated and runs along a side of the drug delivery device 100. A liquid drug cartridge (not shown) can be approximately positioned under the raised portion 106 such that the raised portion 106 accommodates the size and positioning of a liquid drug container within the drug delivery device 100. The top portion 102 can also include a patient interaction element or component 108. In various embodiments, the patient interaction element 108 can be a push button or other patient input device used to activate the drug delivery device 100.
  • The drug delivery device 100 can be a wearable drug delivery device 100. As a wearable device, the drug delivery device 100 can be part of an on-body delivery system (OBDS). The drug delivery device 100 can be coupled to a patient using an adhesive. The drug delivery device 100 can operate as a bolus drug delivery device, or as a continuous drug delivery device. In general, the drug delivery device 100 can provide any amount of a stored liquid drug to a patient over any period of time.
  • FIG. 2 illustrates a side view of the drug delivery device 100. As shown, the drug delivery device 100 can include a soft needle or cannula 110 extending from the bottom portion 104 of the drug delivery device 100. The soft needle or cannula 110 can be a portion of a needle insertion mechanism. In some embodiments, the soft needle or cannula 110 extends from the drug delivery device 100 into the patient once a hard needle of the needle insertion mechanism has been retracted back inside the drug delivery device 100. The soft needle or cannula 110 can extend below the bottom portion 104 when attached to a patient and when delivering a liquid drug to the patient. In various embodiments, the soft needle or cannula 110 can remain extended outside of the drug delivery device 100 after activation.
  • FIG. 3 illustrates a system 300 for removing air from a fluid path of the drug delivery device 100. The system 300 can include a fluid path 112 that employs air eliminating features. The system 300 can be a part or component of the drug delivery device 100. The fluid path 112 can couple a reservoir 114 to a patient or user of the drug delivery device 100. As an example, the fluid path 112 can provide fluid communication between the reservoir 114 and the soft needle or cannula 110 used to provide access to the body of the user of the drug delivery device 100. In various embodiments, the reservoir 114 can be a pre-filled cartridge.
  • The reservoir 114 can store or hold any type of liquid drug 140. As an example, the liquid drug 140 can be insulin. A plunger 142 can be positioned within the reservoir 114. The plunger 142 can be moved to expel the liquid drug 140 from the reservoir 114—by forcing the liquid drug 140 out of the reservoir 114, through the fluid path 112, and on to the soft needle or cannula 110 for delivery to the user. The fluid path 114 can be formed of a variety materials including, for example, plastic, metal, rubber, or any combination thereof. The plunger 142 can be considered to be a pump or pumping system, or a portion thereof, for extracting the liquid drug 140 from the reservoir 114.
  • It will be appreciated that for purposes of discussion, the term “fluid path” (or fluid path component) may be any portion of a fluid path within, or outside, the drug delivery device 100, which is employed to deliver the liquid drug 140 to a user. In the illustrated embodiment, the fluid path 112 runs from the reservoir 114 within the drug delivery device 100 to the soft needle or cannula 110, which can be located either inside or outside the drug delivery device 100.
  • As mentioned, the liquid drug 140 within the reservoir 114 and/or fluid path 112 can contain undesirable quantities of air. With conventional devices, such air may be eliminated from a fluid path using a separate priming step. During priming, a quantity of liquid drug from a liquid drug reservoir is ejected from the end of the drug delivery path to eliminate any air bubbles present in the fluid path. Such priming may not be effective, however, at eliminating air bubbles that exist far back in the fluid path (e.g., closer to the reservoir) or within the fluid reservoir. Thus, priming can be ineffective in ensuring that all air bubbles are removed from the reservoir and fluid path.
  • As shown in FIG. 3, the fluid path 112 can include a venting station or component 118. The venting station 118 can include an opening 144 in a wall of the fluid path 112. The opening can be blocked or covered by a membrane 116. The membrane 116 can comprise a liquid-proof and air-permeable (e.g., hydrophobic) material. The membrane 116 can prevent the liquid drug 140 from passing therethrough, while allowing any air bubbles entrained in the liquid drug 140 to pass therethrough. Specifically, any air or air bubbles within the liquid drug 140 can pass through the membrane 116 as the liquid drug 140 traverses the venting station 118 of the fluid path 112. In doing so, however, the liquid drug 140 is blocked from exiting the fluid path 112 and can be passed along to the soft needle or cannula 110.
  • In various embodiments, based on the arrangement of the venting station 118 and the fluid path 112 as shown in FIG. 3, when an air bubble enters the venting station 118, the pressure inherent in the system 300 will push the air out through the membrane 116 (while retaining the fluid therein), thus removing air bubbles from the liquid drug 140 in the fluid path 112.
  • It will be appreciated that the venting station 118 may be implemented at one or more locations along the length of the fluid path 112. In some embodiments, a venting station 118 can be implemented directly adjacent to, or as part of, the reservoir 114 itself.
  • In some embodiments, the discrete venting station 118 can be eliminated, and the membrane 116 can be directly attached to the fluid path 112 at one or more locations along the length thereof. As an example, the membrane 116 can form a portion of the fluid path 112 (such as a portion of a wall of the fluid path 112). Alternatively, in lieu of the membrane 116, relatively very small channels could be employed in the fluid path 112 itself. The channels can be sized so that they do not allow the liquid drug 140 to flow through (e.g., due to surface tension), but allow air to flow through.
  • It will be appreciated that with the system 300 and arrangements described in relation thereto, air elimination is automatically performed by the system 300, thereby eliminating the additional priming step which is required to be performed by a user of a conventional device.
  • FIGS. 4A-4C illustrate arrangements for preventing fluid from flowing back into the fluid path 112. As mentioned, conventional drug delivery devices can, under certain circumstances, allow fluid from the user's body to flow back into a fluid path of a drug delivery device. Backflow can cause undesirable clogging of the fluid path and/or can result in incorrect dosage of liquid drug to the patient. FIG. 4A illustrates the soft needle or cannula 110 of the fluid path 112 engaged with a user. FIG. 4B illustrates a tip portion 120 of the soft needle or cannula 110 engaged with tissue 122 of the user. FIG. 4C illustrates a flow sensor system 402 coupled to the fluid path 112.
  • As shown in FIG. 4A, the fluid path 112 is shown coupling the reservoir 114 to the tip portion 120 of the soft needle or cannula 110. The tip portion 120 can be engaged with the tissue 122 of a user. The soft needle or cannula 110 can be part of the fluid path 112, which itself is fluidically coupled to the reservoir 114 containing the liquid drug 140 (not shown in FIG. 4A for simplicity).
  • FIG. 4B shows a close-up view of the tip portion 120 of the soft needle or cannula 110 engaged with the tissue 122 of the user. As shown in FIG. 4B, the tip portion 120 of the soft needle or cannula 110 can have a “duckbill” feature 404 attached to, or otherwise integrated into, the soft needle or cannula 110. The duckbill feature 404 can comprise an opening or slit at approximately a center of the tip portion 120 that can open or close. The duckbill feature 404 can be a one-way valve that can only open with a positive pressure imposed from inside the drug delivery device 100, which in some embodiments can be created by the plunger 142 used to dispense the liquid drug 140. In the event that pressure in the user's body (i.e., tissue pressure) is greater than the pressure in the fluid path 112, the duckbill feature 404 can seal itself (as shown in FIG. 4B) and will not allow fluid to travel back into the fluid path 112.
  • Alternatives to the duckbill feature 404 can include the use of one or more one-way check valves (e.g., ball valves) and/or alternative tip arrangements that enable flow in one direction but prevent flow in an opposite direction (e.g., allow flow from the fluid path 112 to the tissue 122 of the user but prevent flow from the user into the fluid path 112).
  • FIG. 4A illustrates the flow sensor system 402 coupled to the fluid path 112. In various embodiments, one or more flow sensor systems can be coupled to the fluid path 112. FIG. 4C shows a close-up view of the flow sensor system 402. The flow sensor system 402 can include a flow sensor 124 positioned to detect the direction of fluid flow through the fluid path 112. If the flow sensor 124 senses that fluid is moving backwards (i.e., from the user to the reservoir 114), then the flow sensor system 402 can activate a “pinch point” to prevent fluid from flowing through the fluid path 112. As shown in FIG. 4C, the pinch point can include a pair of opposing clamping elements 126 a and 126 b (e.g., as part of the flow sensor system 402), which are positioned on opposite sides of the fluid path 112. In various embodiments, the opposing clamping elements 126 a and 126 b can be positioned on opposite sides of the soft needle or cannula 110.
  • The flow sensor system 402 (e.g., via a processor, a controller, or other logic) can, upon receiving signals from the flow sensor 124 indicative of flow moving backwards through the fluid path 112, cause the clamping elements 126 a, 126 b to move toward each other sufficiently to constrict the fluid path 112, thus preventing flow through the fluid path 112. It will be appreciated that in some embodiments, a mechanical fluid flow detector could be employed in lieu of the flow sensor 124. A mechanical fluid flow detector may be desirable for fully-mechanical implementations of the drug delivery devices 100.
  • FIG. 5 illustrates an arrangement and/or a technique for preventing coagulation within the fluid path 112 of the drug delivery device 100. As mentioned, coagulation-based clogging of a fluid path can occur when blood flows from a tissue site, back through the fluid path. If the blood is quickly expelled out through the fluid path, coagulation is not an issue. If blood is allowed to remain in the fluid path, however, coagulation can become a problem.
  • The disclosed arrangement and/or technique can include applying a slow, steady fluid flow (as indicated by flow arrows 502) through the fluid path 112 and out of the soft needle or cannula 110, thus ensuring that blood will not remain in the fluid path 112 long enough to coagulate and block the fluid path.
  • In such embodiments, a minimum flow rate of about 0.25 microliters per hour of liquid through the fluid path 112 may be employed to ensure that entrained particles 128 are always moving toward the delivery site (i.e., from the reservoir 114 toward the user) and thus cannot coagulate. This flow rate can be controlled either mechanically or electronically, via the pumping arrangement of the drug delivery device 100. This minimum flow rate can be provided by a pumping mechanism (e.g., a plunger) configured to extract a fluid from the reservoir 114.
  • While certain embodiments of the present invention have been described, it is expressly noted that the present invention is not limited to those embodiments. Rather, the intention is that additions and modifications to what was expressly described herein are also included within the scope of the invention. Moreover, it is to be understood that the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the spirit and scope of the invention. In fact, variations, modifications, and other implementations of what was described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention. As such, the invention is not to be defined only by the preceding illustrative description.

Claims (20)

1. A wearable drug delivery device, comprising:
a top portion and a bottom portion;
a reservoir between the top portion and the bottom portion and configured to store a liquid drug;
a needle insertion component operable to extend a cannula from the bottom portion into a user, and
a fluid path coupling the reservoir to the cannula, wherein the fluid path is configured to enable delivery of the liquid drug to the user when the liquid drug is expelled from the reservoir, wherein the fluid path includes a membrane operable to retain the liquid drug while allowing air within the liquid drug to pass through the membrane and out of the fluid path.
2. The wearable drug delivery device of claim 1, wherein the membrane covers an opening in the fluid path.
3. The wearable drug delivery device of claim 1, wherein the membrane is directly attached to the fluid path.
4. The wearable drug delivery device of claim 1, wherein the membrane is positioned at one or more locations along a length of the fluid path.
5. The wearable drug delivery device of claim 1, wherein the membrane comprises a hydrophobic material.
6. The wearable drug delivery device of claim 1, wherein the fluid path further includes a flow sensor system.
7. The wearable drug delivery device of claim 6, wherein the flow sensor system comprising a flow sensor, a first clamping component, and a second clamping component.
8. The wearable drug delivery device of claim 7, wherein the flow sensor is configured to detect a direction of a flow of the liquid drug in the fluid path.
9. The wearable drug delivery device of claim 7, wherein the first and second clamping components are positioned on opposite sides of the fluid path.
10. The wearable drug delivery device of claim 9, wherein the first and second clamping components are configured to move toward each other to constrict the fluid path to prevent the flow of the liquid drug in the fluid path.
11. The drug wearable delivery device of claim 8, wherein the first and second clamping components are configured to constrict the fluid path to prevent the flow of the liquid drug when the flow sensor detects the direction of the flow is from the user toward the reservoir.
12. The wearable drug delivery device of claim 8, wherein the first and second clamping components are configured to allow the flow of the liquid drug in the fluid path when the flow sensor detects the direction of the flow is from the reservoir to the user.
13. The drug wearable delivery device of claim 8, wherein the first and second clamping components are positioned on opposite sides of the cannula.
14. The wearable drug delivery device of claim 1, wherein the cannula comprises:
a tip portion having a duckbill feature, wherein the duckbill feature comprises a slit positioned at approximately a center of the tip portion.
15. The wearable drug delivery device of claim 1, wherein the cannula comprises:
a tip portion having a one-way check valve configured to enable flow of the liquid drug out of the tip portion to the user while preventing flow into the tip portion.
16. The wearable drug delivery device of claim 1, further comprising:
a pumping system configured to maintain a minimum flow rate of the liquid drug of 0.25 microliters per hour through the fluid path.
17. The wearable drug delivery device of claim 16, wherein the pumping system comprises:
a plunger positioned within the reservoir.
18. The wearable drug delivery device of claim 1, wherein the reservoir comprises:
a pre-filled cartridge.
19. The wearable drug delivery device of claim 1, further comprising:
an adhesive to secure the wearable drug delivery device to the user.
20. The wearable drug delivery device of claim 19, wherein:
the adhesive is disposed on the bottom portion of the wearable drug delivery device that is against the user.
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