CA2685474C

CA2685474C - Reservoir filling, bubble management, and infusion medium delivery systems and methods with same

Info

Publication number: CA2685474C
Application number: CA2685474A
Authority: CA
Inventors: Julian D. Kavazov; Sheldon B. Moberg; Truong Gia Luan; Ian B. Hanson; Mike Lee; Colin A. Chong; Rafael Bikovsky; Eric Lorenzen; Thomas Miller; Neil Quitoviera
Original assignee: Medtronic Minimed Inc
Current assignee: Medtronic Minimed Inc
Priority date: 2007-04-30
Filing date: 2007-08-23
Publication date: 2014-07-08
Anticipated expiration: 2027-08-23
Also published as: US8083716B2; DK2146760T3; JP2010525868A; CA2685474A1; US20080269681A1; US20090198191A1; EP2146760B1; US20090198215A1; US8025658B2; EP2146760A2; JP5102350B2; WO2008136845A2; US9522225B2

Abstract

A system having a vial. The vial has a diaphragm connected to an inner surface of the vial, the inner surface of the vial and an outer surface of the diaphragm defining an interior volume of the vial for containing a fluidic medium. A vial's bottom surface has an opening for allowing at least one of a gas and a fluidic substance to enter into the vial on an opposite side of the diaphragm from a side of the diaphragm that is in contact with the fluidic medium when the fluidic medium is in the interior volume of the vial. The system includes a pressure providing device for forcing the at least one of the gas and the fluidic substance through the opening in the bottom surface of the vial.

Description

' RESERVOIR FILLING, BUBBLE MANAGEMENT, AND INFUSION
MEDIUM DELIVERY SYSTEMS AND METHODS WITH SAME
[0001]
BACKGROUND OF ME INVENTION

[0002] 1. Field of the Invention [0003] Embodiments of the present invention relate to reservoir filling, bubble management, and infusion medium delivery systems, and methods with the same.

[0004] 2. Related Art [0005] According to modern medical techniques, certain chronic diseases may be treated by delivering a medication or other substance to the body of a patient. For example, diabetes is a chronic disease that is commonly treated by delivering defined amounts of insulin to a patient at appropriate times. Traditionally, manually operated syringes and insulin pens have been employed for delivering insulin to a patient. More recently, modern systems have been designed to include programmable pumps for delivering controlled amounts of medication to a patient.

[0006] Pump type delivery devices have been configured in external devices, which connect to a patient, and have also been configured in implantable devices, which are implanted inside of the body of a patient. External pump type delivery devices include devices designed for use in a stationary location, such as a hospital, a clinic, or the like, and further include devices configured for ambulatory or portable use, such as devices that are designed to be carried by a patient, or the like. External pump type delivery devices may be connected in fluid flow communication to a patient or user, for example, through a suitable hollow tubing. The hollow tubing may be connected to a hollow needle that is designed to pierce the skin of the patient and to deliver a fluidic medium there-through.
Alternatively, the hollow tubing may be connected directly to the patient as through a cannula, or the like.

[0007] Examples of some external pump type delivery devices are described in the following references: (i) Published PCT Application WO 01/70307 (PCT/US01/09139), entitled "Exchangeable Electronic Cards for Infusion Devices"; (ii) Published PCT
Application WO 04/030716 (PCT/US2003/028769), entitled "Components and Methods for Patient Infusion Device"; (iii) Published PCT Application WO 04/030717 (PCT/US2003/029019), entitled "Dispenser Components and Methods for Infusion Device";
(iv) U.S. Patent Application Pub. No. 2005/0065760, entitled "Method for Advising Patients Concerning Doses Of Insulin"; and (v) U.S. Patent No. 6,589,229, entitled "Wearable Self-Contained Drug Infusion Device", each of which is incorporated by reference herein in its entirety.

[0008] As compared to syringes and insulin pens, pump type delivery devices can be significantly more convenient to a patient, in that doses of insulin may be calculated and delivered automatically to a patient at any time during the day or night.
Furthermore, when used in conjunction with glucose sensors or monitors, insulin pumps may be automatically controlled to provide appropriate doses of a fluidic medium at appropriate times of need, based on sensed or monitored levels of blood glucose. As a result, pump type delivery devices have become an important aspect of modern medical treatments of various types of medical conditions, such as diabetes, and the like. As pump technologies improve and doctors and patients become more familiar with such devices, external medical infusion pump treatments are expected to increase in popularity and are expected to increase substantially in number over the next decade.

SUMMARY OF THE DISCLOSURE

[0009] Embodiments of the present invention relate to reservoir filling, bubble management, and infusion medium delivery systems, and methods with the same.
Various embodiments of the present invention are directed to limiting a presence of air bubbles in a fluidic medium expelled from a reservoir. In various embodiments, a reservoir is shaped so as to limit a presence of air bubbles in a fluidic medium expelled from the reservoir. Also, in various embodiments, a plunger head within a reservoir is shaped so as to limit a presence of air bubbles in a fluidic medium expelled from the reservoir. In some embodiments, a reservoir is vibrated so as to shake air bubbles free in a fluidic medium being filled into the reservoir.

[0010] A system in accordance with an embodiment of the present invention includes a reservoir and a plunger head. The plunger head is moveable within the reservoir and has a cavity for receiving at least a portion of a needle when the plunger head is sufficiently advanced within the reservoir and the portion of the needle is inserted into the reservoir. In various embodiments, the reservoir has a body portion and a neck portion.
Also, in various embodiments, the plunger head has a plunger body portion and a plunger neck portion and the cavity is in the plunger neck portion.

[0011] In various embodiments, the system further includes an 0-ring surrounding at least a part of the plunger body portion, where the 0-ring is in contact with the body portion of the reservoir when the plunger body portion is within the body portion of the reservoir.
Also, in various embodiments, the system further includes a septum positioned at an end of the neck portion of the reservoir, and the cavity of the plunger neck portion is located in a position such that the cavity receives the portion of the needle when the plunger head is sufficiently advanced within the reservoir and the needle pierces the septum.

[0012] In some embodiments, an opening of the cavity of the plunger neck portion is located approximately at a center of an end surface of the plunger head. Also, in some embodiments, a contour of an outer surface of the plunger neck portion substantially matches a contour of an inner surface of the neck portion of the reservoir. In various embodiments, a diameter of an outer surface of the plunger neck portion is at least 90% of a diameter of an inner surface of the neck portion of the reservoir.

[0013] In various embodiments, the reservoir further includes a sloped portion between the body portion and the neck portion, and the plunger head further includes a plunger sloped portion between the plunger body portion and the plunger neck portion. In some embodiments, the system further includes a septum positioned at an end of the neck portion of the reservoir, and a length of the plunger neck portion from an end of the plunger neck portion to the plunger sloped portion is at least 90% of a length of the neck portion of the reservoir from the septum to the sloped portion of the reservoir. Also, in some embodiments, the cavity of the plunger neck portion extends into the plunger neck portion a distance that is greater than one-fourth of the length of the plunger neck portion.

[0014] In various embodiments, the plunger neck portion is shaped such that the plunger neck portion fills at least 80% of an area within the neck portion of the reservoir when the plunger head is fully advanced within the reservoir. In some embodiments, the system further includes a drive device including a linkage portion and a motor for moving the linkage portion, and a plunger arm connected to the plunger head, where the plunger arm has a mating portion for mating with the linkage portion of the drive device.
Also, in some embodiments, the system further includes a disposable housing for housing the reservoir and for being secured to a user, and a durable housing for housing the motor of the drive device, where the durable housing is configured to be selectively engaged with and disengaged from the disposable housing.

[0015] A method in accordance with an embodiment of the present invention includes piercing a septum of a reservoir with a needle, and moving a plunger head within the reservoir such that at least a portion of the needle is received within a cavity of the plunger head. In some embodiments, the moving includes moving the plunger head within the reservoir such that a plunger neck portion of the plunger head extends into a neck portion of the reservoir. Also, in some embodiments, the moving includes moving the plunger head within the reservoir such that a portion of the plunger head contacts a portion of the septum.

[0016] In various embodiments, the method further includes retracting the plunger head within the reservoir to allow a fluidic medium to flow through the needle and into the reservoir. Also, in various embodiments, the method further includes removing the needle from the reservoir, piercing the septum of the reservoir with another needle, and moving the plunger head within the reservoir until at least a portion of the another needle is received within the cavity of the plunger head, so as to expel the fluidic medium from the reservoir through the another needle.

[0017] A system in accordance with another embodiment of the present invention includes a reservoir. The reservoir includes a body portion, a port, and a bubble trap portion. The body portion has an interior volume for containing a fluidic medium. The port is in fluid flow communication with the interior volume. The bubble trap portion has a volume in fluid flow communication with the interior volume for trapping air bubbles that are in the fluidic medium as the fluidic medium is being expelled from the interior volume.

[0018] In various embodiments, the port is located to a particular side of the interior volume, and the bubble trap portion is located to the particular side of the interior volume.
In some embodiments, the bubble trap portion has a first portion that extends from the body portion away from the interior volume, and a second portion that returns back toward the interior volume. In various embodiments, the body portion and the bubble trap portion are a single seamless unit.

[0019] In some embodiments, the bubble trap portion has a first portion that extends from the body portion away from the interior volume, and a second portion that extends from the first portion toward the interior volume. Also, in some embodiments, the bubble trap portion includes a curved surface, and the curved surface has a first end region, a second end region, and a middle region between the first end region and the second end region. In further embodiments, the first end region and the second end region are closer to the interior volume than the middle region. Also, in further embodiments, the first end region is in contact with the body portion, and the second end region is located adjacent to the interior volume of the body portion.

[0020] In various embodiments, the bubble trap portion is shaped approximately as a semi-toroid. Also, in various embodiments, a surface of the bubble trap portion that is in contact with the fluidic medium when the fluidic medium is in the volume of the bubble trap portion is approximately U-shaped. In some embodiments, the bubble trap portion includes a first surface that defines an edge of the volume of the bubble trap portion, and a second surface that defines another edge of the volume of the bubble trap portion, where the second surface is positioned at an angle with respect to the first surface. In further embodiments, the angle between the first surface and the second surface is less than 90 degrees.
Also, in further embodiments, the first surface is planar with respect to an inner surface of the body portion.

[0021] In various embodiments, the port is located to a particular side of the interior volume, and a first portion of the bubble trap portion extends from the body portion to the particular side. In further embodiments, the first portion is curved, and a second portion of the bubble trap portion extends from an end of the first portion toward the interior volume.
In some embodiments, the reservoir is shaped such that in order for the fluidic medium to flow from the volume of the bubble trap portion to the port, the fluidic medium must flow through the interior volume. Also, in some embodiments, the reservoir further includes a channel that leads from the interior volume to the port, and the bubble trap portion encircles at least a portion of the channel.

[0022] In various embodiments, the system further includes a plunger head having a plunger body portion and a plunger protruding portion, where the plunger head is moveable within the reservoir. In further embodiments, a contour of the plunger protruding portion substantially matches an inner contour of the bubble trap portion. In some embodiments, the plunger protruding portion has a size such that when the plunger head is fully advanced within the reservoir the plunger protruding portion fills at least 80% of the volume of the bubble trap portion. Also, in some embodiments, the plunger protruding portion fills less than 98% of the volume of the bubble trap portion when the plunger head is fully advanced within the reservoir, so that one or more air pockets for holding air exist between the plunger protruding portion and an inner surface of the bubble trap portion when the plunger head is fully advanced within the reservoir.

[0023] In various embodiments, the plunger protruding portion extends at least partially into the volume of the bubble trap portion when the plunger head is sufficiently advanced within the reservoir. Also, in various embodiments the system further includes a plunger head moveable within the reservoir, where the plunger head has a relief for receiving at least a portion of a needle when the plunger head is sufficiently advanced within the reservoir and the portion of the needle is inserted into the reservoir. In some embodiments, the reservoir includes at least one of a hydrophobic material and a hydrophilic material on at least part of a surface of the bubble trap portion. Also, in some embodiments, the reservoir includes a material for shunting air bubbles in the fluidic medium away from the port and toward the volume of the bubble trap portion when the fluidic medium is being expelled from the interior volume.

[0024] In various embodiments, the system further includes a plunger head moveable within the reservoir, a drive device including a linkage portion and a motor for moving the linkage portion, and a plunger arm connected to the plunger head, where the plunger arm has a mating portion for mating with the linkage portion of the drive device.
Also, in various embodiments, the system includes a disposable housing for housing the reservoir and for being secured to a user, and a durable housing for housing the motor of the drive device, where the durable housing is configured to be selectively engaged with and disengaged from the disposable housing.

[0025] A system in accordance with an embodiment of the present invention includes a holding unit and a vibrator. The holding unit allows for holding a reservoir.
The holding unit is configured such that a plunger arm that is connected to a plunger head that is within the reservoir is moveable when the holding unit is holding the reservoir and the reservoir is being filled with a fluidic medium. The vibrator allows for vibrating the holding unit so as to vibrate the reservoir.

[0026] In various embodiments, the vibrator is configured to vibrate the holding unit when the holding unit is holding the reservoir and the reservoir is being filled with the fluidic medium, so as to vibrate the reservoir and cause air bubbles within the fluidic medium to travel upwards within the reservoir. Also, in various embodiments, the vibrator is configured to shake the holding unit sufficiently when the holding unit is holding the reservoir and the reservoir is being filled with the fluidic medium so as to shake air bubbles free in the fluidic medium.

[0027] In some embodiments, the holding unit includes a first holder and a second holder.
Also, in some embodiments, the plunger arm is moveable within a space between the first holder and the second holder when the reservoir is being held by the first holder and the second holder and the reservoir is being filled with the fluidic medium. In further embodiments, the first holder and the second holder are connected to the vibrator. In some embodiments, the space is also at least partially between the plunger arm and the vibrator.

[0028] In various embodiments, the holding unit is configured such that, when the holding unit is holding the reservoir, the fluidic medium is able to be filled into the reservoir through a port of the reservoir that is located to an opposite side of the plunger head from the plunger arm. Also, in various embodiments, the holding unit is configured such that the plunger arm is moveable in a direction toward the vibrator when the holding unit is holding the reservoir and the reservoir is being filled with the fluidic medium. In some embodiments, the system further includes one or more latches for preventing the plunger arm from being moved when the holding unit is holding the reservoir and prior to a time when the reservoir is being filled with the fluidic medium.

[0029] In various embodiments, the system further includes a transfer guard for transferring the fluidic medium from a vial to the reservoir when the holding unit is holding the reservoir. In some embodiments, the transfer guard includes a first end for at least partially surrounding a port of the reservoir when a needle of the transfer guard pierces a septum in the port of the reservoir. In various embodiments, the holding unit is configured such that a handle connected to the plunger arm is moveable within a space between the reservoir and the vibrator when the holding unit is holding the reservoir and the reservoir is being filled with the fluidic medium.

[0030] A method in accordance with an embodiment of the present invention includes holding a reservoir with a holding unit, moving a plunger arm so as to move a plunger head within the reservoir to allow a fluidic medium to fill into the reservoir when the holding unit is holding the reservoir, and vibrating the holding unit with a vibrator so as to vibrate the reservoir. In various embodiments, the vibrating includes vibrating the holding unit with the vibrator when the holding unit is holding the reservoir and the reservoir is being filled with the fluidic medium. Also, in some embodiments, the vibrating includes vibrating the holding unit with the vibrator so as to vibrate the reservoir to cause air bubbles within the fluidic medium to travel upwards within the reservoir.

[0031] In some embodiments, the moving includes moving the plunger arm toward the vibrator so as to move the plunger head within the reservoir to allow the fluidic medium to fill into the reservoir when the holding unit is holding the reservoir. In various embodiments, the method further includes moving one or more latches to allow the plunger arm to be moved when the holding unit is holding the reservoir. In some embodiments, the method further includes piercing a septum located within a port of the reservoir with a needle of a transfer guard to allow the fluidic medium to be transferred from a vial to the reservoir through the needle. Also, in some embodiments, the method further includes pushing air out of the reservoir after the reservoir has been vibrated.
BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 illustrates a generalized representation of a system in accordance with an embodiment of the present invention;

[0033] FIG. 2 illustrates an example of a system in accordance with an embodiment of the present invention;

[0034] FIG. 3 illustrates an example of a delivery device in accordance with an embodiment of the present invention;

[0035] FIG. 4 illustrates a delivery device in accordance with an embodiment of the present invention;

[0036] FIG. 5A illustrates a durable portion of a delivery device in accordance with an embodiment of the present invention;

[0037] FIG. 5B illustrates a section view of a durable portion of a delivery device in accordance with an embodiment of the present invention;

[0038] FIG. 5C illustrates a section view of a durable portion of a delivery device in accordance with an embodiment of the present invention;

[0039] FIG. 6A illustrates a disposable portion of a delivery device in accordance with an embodiment of the present invention;

[0040] FIG. 6B illustrates a section view of a disposable portion of a delivery device in accordance with an embodiment of the present invention;

[0041] FIG. 6C illustrates a section view of a disposable portion of a delivery device in accordance with an embodiment of the present invention;

[0042] FIG. 7A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0043] FIG. 7B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0044] FIG. 7C illustrates a cross-sectional view from a front direction of a plunger neck portion of a plunger head in accordance with an embodiment of the present invention;

[0045] FIG. 7D illustrates a side view of a plunger head in accordance with an embodiment of the present invention;

[0046] FIG. 8 illustrates a flowchart for a method in accordance with an embodiment of the present invention;

[0047] FIG. 9A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0048] FIG. 9B illustrates a cross-sectional view of a reservoir in accordance with an embodiment of the present invention;

[0049] FIG. 10A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0050] FIG. 10B illustrates a cross-sectional view of a reservoir in accordance with an embodiment of the present invention;

[0051] FIG. 11A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0052] FIG. 11B illustrates a cross-sectional view of a reservoir in accordance with an embodiment of the present invention;

[0053] FIG. 12A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0054] FIG. 12B illustrates a cross-sectional view of a reservoir in accordance with an embodiment of the present invention;

[0055] FIG. 12C illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0056] FIG. 13A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0057] FIG. 13B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0058] FIG. 14 illustrates a flowchart for a method in accordance with an embodiment of the present invention;

[0059] FIG. 15 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0060] FIG. 16A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0061] FIG. 16B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0062] FIG. 17A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0063] FIG. 17B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0064] FIG. 18A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0065] FIG. 18B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0066] FIG. 19 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0067] FIG. 20A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0068] FIG. 20B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0069] FIG. 21A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0070] FIG. 21B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0071] FIG. 21C illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0072] FIG. 21D illustrates a cross-sectional top view of a system in accordance with an embodiment of the present invention;

[0073] FIG. 21E illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0074] FIG. 21F illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0075] FIG. 22A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0076] FIG. 22B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0077] FIG. 22C illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0078] FIG. 23A illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0079] FIG. 23B illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0080] FIG. 24 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0081] FIG. 25 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0082] FIG. 26 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0083] FIG. 27 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0084] FIG. 28 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0085] FIG. 29 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0086] FIG. 30 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0087] FIG. 31 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention;

[0088] FIG. 32 illustrates a cross-sectional view of a system in accordance with an embodiment of the present invention; and [0089] FIG. 33 illustrates an adhesive patch in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0090] FIG. 1 illustrates a generalized representation of a system 10 in accordance with an embodiment of the present invention. The system 10 includes a delivery device 12. The system 10 may further include a sensing device 14, a command control device (CCD) 16, and a computer 18. In various embodiments, the delivery device 12 and the sensing device 14 may be secured at desired locations on the body 5 of a patient or user 7.
The locations at which the delivery device 12 and the sensing device 14 are secured to the body 5 of the user 7 in FIG. 1 are provided only as representative, non-limiting, examples.

[0091] The delivery device 12 is configured to deliver a fluidic medium to the body 5 of the user 7. In various embodiments, the fluidic medium includes a liquid, a fluid, a gel, or the like. In some embodiments, the fluidic medium includes a medicine or a drug for treating a disease or a medical condition. For example, the fluidic medium may include insulin for treating diabetes, or may include a drug for treating pain, cancer, a pulmonary disorder, HIV, or the like. In some embodiments, the fluidic medium includes a nutritional supplement, a dye, a tracing medium, a saline medium, a hydration medium, or the like.

[0092] The sensing device 14 includes a sensor, a monitor, or the like, for providing sensor data or monitor data. In various embodiments, the sensing device 14 may be configured to sense a condition of the user 7. For example, the sensing device 14 may include electronics and enzymes reactive to a biological condition, such as a blood glucose level, or the like, of the user 7. In various embodiments, the sensing device 14 may be secured to the body 5 of the user 7 or embedded in the body 5 of the user 7 at a location that is remote from the location at which the delivery device 12 is secured to the body 5 of the user 7. In various other embodiments, the sensing device 14 may be incorporated within the delivery device 12.

[0093] Each of the delivery device 12, the sensing device 14, the CCD 16, and the computer 18 may include transmitter, receiver, or transceiver electronics that allow for communication with other components of the system 10. The sensing device 14 may be configured to transmit sensor data or monitor data to the delivery device 12.
The sensing device 14 may also be configured to communicate with the CCD 16. The delivery device 12 may include electronics and software that are configured to analyze sensor data and to deliver the fluidic medium to the body 5 of the user 7 based on the sensor data and/or preprogrammed delivery routines.

[0094] The CCD 16 and the computer 18 may include electronics and other components configured to perform processing, delivery routine storage, and to control the delivery device 12. By including control functions in the CCD 16 and/or the computer 18, the delivery device 12 may be made with more simplified electronics. However, in some embodiments, the delivery device 12 may include all control functions, and may operate without the CCD 16 and the computer 18. In various embodiments, the CCD 16 may be a portable electronic device. Also, in various embodiments, the delivery device 12 and/or the sensing device 14 may be configured to transmit data to the CCD 16 and/or the computer 18 for display or processing of the data by the CCD 16 and/or the computer 18.
Examples of the types of communications and/or control capabilities, as well as device feature sets and/or program options may be found in the following references: (i) U.S. Patent Application Serial No. 10/445,477, filed May 27, 2003, entitled "External Infusion Device with Remote Programming, Bolus Estimator and/or Vibration Alarm Capabilities"; (ii) U.S.
Patent Application Serial No. 10/429,385, filed May 5, 2003, entitled "Handheld Personal Data Assistant (PDA) with a Medical Device and Method of Using the Same"; and (iii) U.S.
Patent Application Serial No. 09/813,660, filed March 21, 2001, entitled "Control Tabs for Infusion Devices and Methods of Using the Same", all of which are incorporated herein by reference in their entirety.

[0095] FIG. 2 illustrates an example of the system 10 in accordance with an embodiment of the present invention. The system 10 in accordance with the embodiment illustrated in FIG. 2 includes the delivery device 12 and the sensing device 14. The delivery device 12 in accordance with an embodiment of the present invention includes a disposable housing 20, a durable housing 30, and a reservoir 40. The delivery device 12 may further include an infusion path 50.

[0096] Elements of the delivery device 12 that ordinarily contact the body of a user or that ordinarily contact a fluidic medium during operation of the delivery device 12 may be considered as a disposable portion of the delivery device 12. For example, a disposable portion of the delivery device 12 may include the disposable housing 20 and the reservoir 40. The disposable portion of the delivery device 12 may be recommended for disposal after a specified number of uses.

[0097] On the other hand, elements of the delivery device 12 that do not ordinarily contact the body of the user or the fluidic medium during operation of the delivery device 12 may be considered as a durable portion of the delivery device 12. For example, a durable portion of the delivery device 12 may include the durable housing 30, electronics (not shown in FIG.
2), a drive device having a motor and drive linkage (not shown in FIG. 2), and the like.
Elements of the durable housing portion of the delivery device 12 are typically not contaminated from contact with the user or the fluidic medium during normal operation of the delivery device 12 and, thus, may be retained for re-use with replaced disposable portions of the delivery device 12.

[0098] In various embodiments, the disposable housing 20 supports the reservoir 40 and has a bottom surface (facing downward and into the page in FIG. 2) that is configured to secure to the body of a user. An adhesive may be employed at an interface between the bottom surface of the disposable housing 20 and the skin of a user, so as to adhere the disposable housing 20 to the skin of the user. In various embodiments, the adhesive may be provided on the bottom surface of the disposable housing 20, with a peelable cover layer covering the adhesive material. In this manner, the cover layer may be peeled off to expose the adhesive material, and the adhesive side of the disposable housing 20 may be placed against the skin of the user.

[0099] The reservoir 40 is configured for containing or holding a fluidic medium, such as, but not limited to insulin. In various embodiments, the reservoir 40 includes a hollow interior volume for receiving the fluidic medium, such as, but not limited to, a cylinder-shaped volume, a tubular-shaped volume, or the like. In some embodiments, the reservoir 40 may be provided as a cartridge or canister for containing a fluidic medium.
In various embodiments, the reservoir 40 is able to be refilled with a fluidic medium.

[0100] The reservoir 40 may be supported by the disposable housing 20 in any suitable manner. For example, the disposable housing 20 may be provided with projections or struts (not shown), or a trough feature (not shown), for holding the reservoir 40. In some embodiments, the reservoir 40 may be supported by the disposable housing 20 in a manner that allows the reservoir 40 to be removed from the disposable housing 20 and replaced with another reservoir. Alternatively, or in addition, the reservoir 40 may be secured to the disposable housing 20 by a suitable adhesive, a strap, or other coupling structure.

[0101] In various embodiments, the reservoir 40 includes a port 41 for allowing a fluidic medium to flow into and/or flow out of the interior volume of the reservoir 40. In some embodiments, the infusion path 50 includes a connector 56, a tube 54, and a needle apparatus 52. The connector 56 of the infusion path 50 may be connectable to the port 41 of the reservoir 40. In various embodiments, the disposable housing 20 is configured with an opening near the port 41 of the reservoir 40 for allowing the connector 56 of the infusion path 50 to be selectively connected to and disconnected from the port 41 of the reservoir 40.

[0102] In various embodiments, the port 41 of the reservoir 40 is covered with or supports a septum (not shown in FIG. 2), such as a self-sealing septum, or the like.
The septum may be configured to prevent a fluidic medium from flowing out of the reservoir 40 through the port 41 when the septum is not pierced. Also, in various embodiments, the connector 56 of the infusion path 50 includes a needle for piercing the septum covering the port 41 of the reservoir 40 so as to allow the fluidic medium to flow out of the interior volume of the reservoir 40. Examples of needle/septum connectors can be found in U.S. Patent Application Serial No. 10/328,393, filed December 22, 2003, entitled "Reservoir Connector", which is incorporated herein by reference in its entirety. In other alternatives, non-septum connectors such as Luer locks, or the like may be used. In various embodiments, the needle apparatus 52 of the infusion path 50 includes a needle that is able to puncture the skin of a user. Also, in various embodiments, the tube 54 connects the connector 56 with the needle apparatus 52 and is hollow, such that the infusion path 50 is able to provide a path to allow for the delivery of a fluidic medium from the reservoir 40 to the body of a user.

[0103] The durable housing 30 of the delivery device 12 in accordance with various embodiments of the present invention includes a housing shell configured to mate with and secure to the disposable housing 20. The durable housing 30 and the disposable housing 20 may be provided with correspondingly shaped grooves, notches, tabs, or other suitable features, that allow the two parts to easily connect together, by manually pressing the two housings together, by twist or threaded connection, or other suitable manner of connecting the parts that is well known in the mechanical arts. In various embodiments, the durable housing 30 and the disposable housing 20 may be connected to each other using a twist action. The durable housing 30 and the disposable housing 20 may be configured to be separable from each other when a sufficient force is applied to disconnect the two housings from each other. For example, in some embodiments the disposable housing 20 and the durable housing 30 may be snapped together by friction fitting. In various embodiments, a suitable seal, such as an o-ring seal, may be placed along a peripheral edge of the durable housing 30 and/or the disposable housing 20, so as to provide a seal against water entering between the durable housing 30 and the disposable housing 20.

[0104] The durable housing 30 of the delivery device 12 may support a drive device (not shown in FIG. 2), including a motor and a drive device linkage portion, for applying a force to the fluidic medium within the reservoir 40 to force the fluidic medium out of the reservoir 40 and into an infusion path, such as the infusion path 50, for delivery to a user. For example, in some embodiments, an electrically driven motor may be mounted within the durable housing 30 with appropriate linkage for operatively coupling the motor to a plunger arm (not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2) that is within the reservoir 40 and to drive the plunger head in a direction to force the fluidic medium out of the port 41 of the reservoir 40 and to the user. Also, in some embodiments, the motor may be controllable to reverse direction so as to move the plunger arm and the plunger head to cause fluid to be drawn into the reservoir 40 from a patient. The motor may be arranged within the durable housing 30 and the reservoir 40 may be correspondingly arranged on the disposable housing 20, such that the operable engagement of the motor with the plunger head, through the appropriate linkage, occurs automatically upon the user connecting the durable housing 30 with the disposable housing 20 of the delivery device 12.
Further examples of linkage and control structures may be found in U.S. Patent Application Serial No. 09/813,660, filed March 21, 2001, entitled "Control Tabs for Infusion Devices and Methods of Using the Same", which is incorporated herein by reference in its entirety.

[0105] In various embodiments, the durable housing 30 and the disposable housing 20 may be made of suitably rigid materials that maintain their shape, yet provide sufficient flexibility and resilience to effectively connect together and disconnect, as described above.
The material of the disposable housing 20 may be selected for suitable compatibility with skin. For example, the disposable housing 20 and the durable housing 30 of the delivery device 12 may be made of any suitable plastic, metal, composite material, or the like. The disposable housing 20 may be made of the same type of material or a different material relative to the durable housing 30. In some embodiments, the disposable housing 20 and the durable housing 30 may be manufactured by injection molding or other molding processes, machining processes, or combinations thereof [0106] For example, the disposable housing 20 may be made of a relatively flexible material, such as a flexible silicone, plastic, rubber, synthetic rubber, or the like. By forming the disposable housing 20 of a material capable of flexing with the skin of a user, a greater level of user comfort may be achieved when the disposable housing 20 is secured to the skin of the user. Also, a flexible disposable housing 20 may result in an increase in site options on the body of the user at which the disposable housing 20 may be secured.

[0107] In the embodiment illustrated in FIG. 2, the delivery device 12 is connected to the sensing device 14 through a connection element 16 of the sensing device 14.
The sensing device 14 may include a sensor 15 that includes any suitable biological or environmental sensing device, depending upon a nature of a treatment to be administered by the delivery device 12. For example, in the context of delivering insulin to a diabetes patient, the sensor 15 may include a blood glucose sensor, or the like.

[0108] The sensor 15 may be an external sensor that secures to the skin of a user or, in other embodiments, may be an implantable sensor that is located in an implant site within the body of the user. In further alternatives, the sensor may be included with as a part or along side the infusion cannula and/or needle, such as for example as shown in U.S. Patent Application Serial No. 11/149,119, filed June 8, 2005, entitled "Dual Insertion Set", which is incorporated herein by reference in its entirety. In the illustrated example of FIG. 2, the sensor 15 is an external sensor having a disposable needle pad that includes a needle for piercing the skin of the user and enzymes and/or electronics reactive to a biological condition, such as blood glucose level or the like, of the user. In this manner, the delivery device 12 may be provided with sensor data from the sensor 15 secured to the user at a site remote from the location at which the delivery device 12 is secured to the user.

[0109] While the embodiment shown in FIG. 2 includes a sensor 15 connected by the connection element 16 for providing sensor data to sensor electronics (not shown in FIG. 2) located within the durable housing 30 of the delivery device 12, other embodiments may employ a sensor 15 located within the delivery device 12. Yet other embodiments may employ a sensor 15 having a transmitter for communicating sensor data by a wireless communication link with receiver electronics (not shown in FIG. 2) located within the durable housing 30 of the delivery device 12. In various embodiments, a wireless connection between the sensor 15 and the receiver electronics within the durable housing 30 of the delivery device 12 may include a radio frequency (RF) connection, an optical connection, or another suitable wireless communication link. Further embodiments need not employ the sensing device 14 and, instead, may provide fluidic medium delivery functions without the use of sensor data.

[0110] As described above, by separating disposable elements of the delivery device 12 from durable elements, the disposable elements may be arranged on the disposable housing 20, while durable elements may be arranged within a separable durable housing 30. In this regard, after a prescribed number of uses of the delivery device 12, the disposable housing 20 may be separated from the durable housing 30, so that the disposable housing 20 may be disposed of in a proper manner. The durable housing 30 may then be mated with a new (un-used) disposable housing 20 for further delivery operation with a user.

[0111] FIG. 3 illustrates an example of the delivery device 12 in accordance with another embodiment of the present invention. The delivery device 12 of the embodiment of FIG. 3 is similar to the delivery device 12 of the embodiment of FIG. 2. While the delivery device 12 in the embodiment illustrated in FIG. 2 provides for the durable housing 30 to cover the reservoir 40, the delivery device 12 in the embodiment of FIG. 3 provides for the durable housing 30 to secure to the disposable housing 20 without covering the reservoir 40. The delivery device 12 of the embodiment illustrated in FIG. 3 includes the disposable housing 20, and the disposable housing 20 in accordance with the embodiment illustrated in FIG. 3 includes a base 21 and a reservoir retaining portion 24. In one embodiment, the base 21 and reservoir retaining portion 24 may be formed as a single, unitary structure.

[0112] The base 21 of the disposable housing 20 is configured to be secured to the body of a user. The reservoir retaining portion 24 of the disposable housing 20 is configured to house the reservoir 40. The reservoir retaining portion 24 of the disposable housing 20 may be configured to have an opening to allow for the port 41 of the reservoir 40 to be accessed from outside of the reservoir retaining portion 24 while the reservoir 40 is housed in the reservoir retaining portion 24. The durable housing 30 may be configured to be attachable to and detachable from the base 21 of the disposable housing 20. The delivery device 12 in the embodiment illustrated in FIG. 3 includes a plunger arm 60 that is connected to or that is connectable to a plunger head (not shown in FIG. 3) within the reservoir 40.

[0113] FIG. 4 illustrates another view of the delivery device 12 of the embodiment of FIG.
3. The delivery device 12 of the embodiment illustrated in FIG. 4 includes the disposable housing 20, the durable housing 30, and the infusion path 50. The disposable housing 20 in the embodiment of FIG. 4 includes the base 21, the reservoir retaining portion 24, and a peelable cover layer 25. The peelable cover layer 25 may cover an adhesive material on the bottom surface 22 of the base 21. The peelable cover layer 25 may be configured to be peelable by a user to expose the adhesive material on the bottom surface 22 of the base 21.
In some embodiments, there may be multiple adhesive layers on the bottom surface 22 of the base 21 that are separated by peelable layers.

[0114] The infusion path 50 in accordance with the embodiment of the present invention illustrated in FIG. 4 includes the needle 58 rather than the connector 56, the tube 54, and the needle apparatus 52 as shown in the embodiment of FIG. 2. The base 21 of the disposable housing 20 may be provided with an opening or pierceable wall in alignment with a tip of the needle 58, to allow the needle 58 to pass through the base 21 and into the skin of a user under the base 21, when extended. In this manner, the needle 58 may be used to pierce the skin of the user and deliver a fluidic medium to the user.

[0115] Alternatively, the needle 58 may be extended through a hollow cannula (not shown in FIG. 4), such that upon piercing the skin of the user with the needle 58, an end of the hollow cannula is guided through the skin of the user by the needle 58.
Thereafter, the needle 58 may be removed, leaving the hollow cannula in place, with one end of the cannula located within the body of the user and the other end of the cannula in fluid flow connection with the fluidic medium within the reservoir 40, to convey pumped infusion media from the reservoir 40 to the body of the user.

[0116] FIG. 5A illustrates a durable portion 8 of the delivery device 12 (refer to FIG. 3) in accordance with an embodiment of the present invention. FIG. 5B illustrates a section view of the durable portion 8 in accordance with an embodiment of the present invention. FIG.
5C illustrates another section view of the durable portion 8 in accordance with an embodiment of the present invention. With reference to FIGs. 5A, 5B, and 5C, in various embodiments, the durable portion 8 includes the durable housing 30, and a drive device 80.
The drive device 80 includes a motor 84 and a drive device linkage portion 82.
In various embodiments, the durable housing 30 may include an interior volume for housing the motor 84, the drive device linkage portion 82, other electronic circuitry, and a power source (not shown in FIGs. 5A, 5B, and 5C). Also, in various embodiments, the durable housing 30 is configured with an opening 32 for receiving a plunger arm 60 (refer to FIG.
3). Also, in various embodiments, the durable housing 30 may include one or more connection members 34, such as tabs, insertion holes, or the like, for connecting with the base 21 of the disposable housing 20 (refer to FIG. 3).

[0117] FIG. 6A illustrates a disposable portion 9 of the delivery device 12 (refer to FIG. 3) in accordance with an embodiment of the present invention. FIG. 6B illustrates a section view of the disposable portion 9 in accordance with an embodiment of the present invention.
FIG. 6C illustrates another section view of the disposable portion 9 in accordance with an embodiment of the present invention. With reference to FIGs. 6A, 6B, and 6C, in various embodiments, the disposable portion 9 includes the disposable housing 20, the reservoir 40, the plunger arm 60, and a plunger head 70. In some embodiments, the disposable housing 20 includes the base 21 and the reservoir retaining portion 24. In various embodiments, the base 21 includes a top surface 23 having one or more connection members 26, such as tabs, grooves, or the like, for allowing connections with the one or more connection members 34 of embodiments of the durable housing 30 (refer to FIG. 5B).

[0118] In various embodiments, the reservoir 40 is housed within the reservoir retaining portion 24 of the disposable housing 20, and the reservoir 40 is configured to hold a fluidic medium. Also, in various embodiments, the plunger head 70 is disposed at least partially within the reservoir 40 and is moveable within the reservoir 40 to allow the fluidic medium to fill into the reservoir 40 and to force the fluidic medium out of the reservoir 40. In some embodiments, the plunger arm 60 is connected to or is connectable to the plunger head 70.
Also, in some embodiments, a portion of the plunger arm 60 extends to outside of the reservoir retaining portion 24 of the disposable housing 20. In various embodiments, the plunger arm 60 has a mating portion for mating with the drive device linkage portion 82 of the drive device 80 (refer to FIG. 5C). With reference to FIGs. 5C and 6C, in some embodiments, the durable housing 30 may be snap fitted onto the disposable housing 20, whereupon the drive device linkage portion 82 automatically engages the mating portion of the plunger arm 60.

[0119] When the durable housing 30 and the disposable housing 20 are fitted together with the drive device linkage portion 82 engaging or mating with the plunger arm 60, the motor 84 may be controlled to drive the drive device linkage portion 82 and, thus, move the plunger arm 60 to cause the plunger head 70 to move within the reservoir 40.
When the interior volume of the reservoir 40 is filled with a fluidic medium and an infusion path is provided from the reservoir 40 to the body of a user, the plunger head 70 may be moved within the reservoir 40 to force the fluidic medium from the reservoir 40 and into the infusion path, so as to deliver the fluidic medium to the body of the user.

[0120] In various embodiments, once the reservoir 40 has been sufficiently emptied or otherwise requires replacement, a user may simply remove the durable housing 30 from the disposable housing 20, and replace the disposable portion 9, including the reservoir 40, with a new disposable portion having a new reservoir. The durable housing 30 may be connected to the new disposable housing of the new disposable portion, and the delivery device including the new disposable portion may be secured to the skin of a user. In various other embodiments, rather than replacing the entire disposable portion 9 every time the reservoir 40 is emptied, the reservoir 40 may be refilled with a fluidic medium. In some embodiments, the reservoir 40 may be refilled while remaining within the reservoir retaining portion 24 (refer to FIG. 6B) of the disposable housing 20. Also, in various embodiments, the reservoir 40 may be replaced with a new reservoir (not shown), while the disposable housing 20 may be re-used with the new reservoir. In such embodiments, the new reservoir may be inserted into the disposable portion 9.

[0121] With reference to FIGs. 3, 5A, 6B, and 6C, in various embodiments, the delivery device 12 includes reservoir status circuitry (not shown), and the reservoir 40 includes reservoir circuitry (not shown). In various embodiments, the reservoir circuitry stores information such as, but not limited to, at least one of (i) an identification string identifying the reservoir 40; (ii) a manufacturer of the reservoir 40; (iii) contents of the reservoir 40; and (iv) an amount of contents in the reservoir 40. In some embodiments, the delivery device 12 includes the reservoir status circuitry (not shown), and the reservoir status circuitry is configured to read data from the reservoir circuitry when the reservoir 40 is inserted into the disposable portion 9.

[0122] In various embodiments, the reservoir status circuitry is further configured to store data to the reservoir circuitry after at least some of the contents of the reservoir 40 have been transferred out of the reservoir 40, so as to update information in the reservoir circuitry related to an amount of contents still remaining in the reservoir 40. In some embodiments, the reservoir status circuitry is configured to store data to the reservoir circuitry, so as to update information in the reservoir circuitry related to an amount of contents still remaining in the reservoir 40, when the reservoir 40 is inserted into the disposable portion 9. In some embodiments, the delivery device 12 includes the reservoir status circuitry (not shown) and the reservoir 40 includes the reservoir circuitry (not shown), and the reservoir status circuitry selectively inhibits use of the delivery device 12 or selectively provides a warning signal based on information read by the reservoir status circuitry from the reservoir circuitry.

[0123] FIG. 7A illustrates a cross-sectional view of a system 100 in accordance with an embodiment of the present invention. The system 100 includes a reservoir 110, a plunger head 120, a plunger arm 130, and a septum 140. In various embodiments, the system 100 further includes a needle 150. In some embodiments, the system 100 may further include similar elements as elements of embodiments of the delivery device 12 (refer to FIGS. 2 and 3), in which case the reservoir 110 would correspond to the reservoir 40 (refer to FIGS. 2, 3, and 6C). In various embodiments, the reservoir 110 may be made of a material, such as but not limited to a suitable metal, plastic, ceramic, glass, composite material, or the like. In various embodiments, the plunger head 120 may be made of a suitably rigid material such as, but not limited to, metal, plastic, ceramic, glass, composite material, or the like. In various other embodiments, the plunger head 120 may be made of a compressible material such as, but not limited to, an elastically compressible plastic, rubber, silicone, or the like.

[0124] In various embodiments, the reservoir 110 includes a body portion 111, a body headspace or neck portion 112, and a curved or sloped portion 117 that connects the body portion 111 and the neck portion 112. The reservoir 110 has an outer surface 113 and an inner surface 114. The inner surface 114 of the reservoir 110 defines a hollow interior of the reservoir 110, and the hollow interior of the reservoir 110 is able to contain a fluidic medium. The reservoir 110 further includes a port 118 at an end of the neck portion 112, through which the fluidic medium may be filled into or expelled from the hollow interior of the reservoir 110. The body portion 111 of the reservoir 110 may have any suitable shape and may have, for example, a cylinder shape, a tube shape, a barrel shape, a spherical shape, a shape with a rectangular cross-section, or the like. Similarly, the neck portion 112 of the reservoir 110 may have any suitable shape and may have, for example, a cylinder shape, a tube shape, a barrel shape, a spherical shape, a shape with a rectangular cross-section, or the like.

[0125] The plunger head 120 is located within the reservoir 110, and is moveable in an axial direction of the reservoir 110, to expand or contract an interior volume of the reservoir 110 in which a fluidic medium may be contained. The plunger head 120 is connected to the plunger arm 130, such that movement of the plunger arm 130 in the axial direction of the reservoir 110 causes movement of the plunger head 120 in the axial direction of the reservoir 110. The plunger head 120 includes a plunger body portion 121, a plunger headspace or neck portion 122, and a plunger curved or sloped portion 123 that connects the plunger body portion 121 and the plunger neck portion 122. In various embodiments, the plunger head 120 further includes one or more 0-rings 125 that surround a portion of the plunger body portion 121.

[0126] The plunger body portion 121 is shaped such that a contour of an outer surface of the plunger body portion 121 substantially matches or is substantially the same as a contour of an inner surface of the body portion 111 of the reservoir 110. In various embodiments, the plunger body portion 121 has a diameter that is slightly smaller than a diameter of the inner surface of the body portion 111 of the reservoir 110, such that the plunger head 120 is able to slide within the reservoir 110. In some embodiments, the one or more 0-rings 125 on the plunger body portion 121 are in contact with the inner surface of the body portion 111 of the reservoir 110 when the plunger head 120 is within the reservoir 110.

[0127] The plunger neck portion 122 is shaped such that a contour of an outer surface of the plunger neck portion 122 substantially matches or is substantially the same as a contour of an inner surface of the neck portion 112 of the reservoir 110. In various embodiments, the plunger neck portion 122 has a diameter that is slightly smaller than a diameter of the inner surface of the neck portion 112 of the reservoir 110, such that the plunger neck portion 122 is able to slide within the neck portion 112 of the reservoir 110. In some embodiments, a diameter of an outer surface of the plunger neck portion 122 is at least 90%
of a diameter of an inner surface of the neck portion 112 of the reservoir 110. Also, in some embodiments, the plunger neck portion 122 is shaped such that the plunger neck portion 122 fills at least 80% of an area within the neck portion 112 of the reservoir 110 when the plunger head 120 is fully advanced within the reservoir 110. The plunger sloped portion 123 is shaped such that a contour of an outer surface of the plunger sloped portion 123 substantially matches or is substantially the same as a contour of an inner surface of the sloped portion 117 of the reservoir 110.

[0128] The septum 140 is located at the port 118 of the reservoir 110. The septum 140 may be formed of a suitable material, such as, but not limited to, rubber, silicone rubber, polyurethane, or other materials that may be pierced by a needle and form a seal around a needle. The neck portion 112 has a certain length from an end of the sloped portion 117 to the septum 140. In various embodiments, the plunger neck portion 122 has a length that is substantially the same as the certain length of the neck portion 112 of the reservoir 110. In some such embodiments, the plunger neck portion 122 is able to extend substantially all of the way into the neck portion 112 of the reservoir 110 when the plunger head 120 is fully advanced within the reservoir 110. Thus, in some embodiments, an end of the plunger neck portion 122 may be close to or in contact with the septum 140 when the plunger head 120 is fully advanced within the reservoir 110. In various embodiments, a length of the plunger neck portion 122 from an end of the plunger neck portion 122 to the plunger sloped portion 123 is at least 90% of a length of the neck portion 112 of the reservoir 110 from the septum 140 to the sloped portion 117 of the reservoir 110.

[0129] The septum 140 is able to be pierced by the needle 150, such as to allow for a fluidic medium to be passed through the needle 150 and into the hollow interior of the reservoir 110. In various embodiments, the plunger head 120 includes a hole or a channel or a relief or a cavity 124 that is able to accommodate a portion of the needle 150 when the plunger head 120 is sufficiently advanced within the reservoir 110 and the septum 140 is pierced by the needle 150. The cavity 124 may have any suitable shape for accommodating a portion of the needle 150, and may have, for example, a cylindrical shape, a tube shape with a half-sphere bottom, a shape with a rectangular cross-section, or the like. In various embodiments, a diameter of the cavity 124 is larger than a diameter of the needle 150, such that an end of the needle 150 is able to fit within the cavity 124.

[0130] In various embodiments, the cavity 124 is in the plunger neck portion 122 of the plunger head 120. In some embodiments, a length of the cavity 124 in the plunger neck portion 122 in a direction from the septum 140 toward the plunger body portion 121 is greater than one-quarter of a length of the plunger neck portion 122. Also, in some embodiments, the cavity 124 is positioned at a center of an end surface of the plunger neck portion 122. In various embodiments, an end of the neck portion 112 of the reservoir 110 partially covers the septum 140, such that the needle 150 may only pierce the septum 140 in a location that is aligned with the cavity 124 of the plunger head 120.

[0131] FIG. 8 illustrates a flowchart for a method in accordance with an embodiment of the present invention. With reference to FIGS. 7A and 8, in various embodiments the method of FIG. 8 allows for filling the reservoir 110 with a fluidic medium and for expelling the fluidic medium from the reservoir 110. In S10, the septum 140 of the reservoir 110 is pierced with the needle 150, and the method continues to S11. In S11, the plunger head 120 is advanced within the reservoir 110, such that at least a portion of the needle 150 is received within the cavity 124 of the plunger head 120. For example, the plunger arm 130 may be driven by a motor (not shown in FIG. 7A) or by a force applied by a user to advance the plunger head 120 within the reservoir 110. In various embodiments, moving the plunger head 120 includes moving the plunger head 120 within the reservoir 110 such that the plunger neck portion 122 extends at least partially into the neck portion 112 of the reservoir 110 (S12). Also, in various embodiments, moving the plunger head 120 includes moving the plunger head 120 within the reservoir 110 such that a portion of the plunger head 120 contacts a portion of the septum 140 (S13). In some embodiments, S10 and Sll are performed in a reverse order, such that the plunger head 120 is moved and then the septum 140 is pierced with the needle 150.

[0132] When the plunger head 120 is sufficiently advanced within the reservoir 110, a portion of the needle 150 may extend into the cavity 124 of the plunger neck portion 122, which may allow the plunger neck portion 122 to extend substantially all the way to the septum 140. As a consequence, a presence of air pockets between an end of the plunger head 120 and the septum 140 is able to be substantially limited or eliminated when the plunger head 120 is fully advanced within the reservoir 110. Reducing air pockets between the plunger head 120 and the septum 140 prior to filling the reservoir 110 is beneficial, because it limits an amount of air bubbles that subsequently enter the fluidic medium when the fluidic medium is drawn into the reservoir 110.

[0133] In various embodiments, the method then continues to S14. In S14, the plunger head 120 is retracted within the reservoir 110 to allow a fluidic medium to flow through the needle 150 and into the reservoir 110. For example, the plunger arm 130 may be retracted by a motor (not shown in FIG. 7A) or by a pulling force exerted by a user to cause the plunger head 120 to retract within the reservoir 110. FIG. 7B illustrates a cross-sectional view of the system 100 in accordance with an embodiment of the present invention when the plunger head 120 has been partially retracted within the reservoir 110. By retracting the plunger head 120 within the reservoir 110, the fluidic medium is able to pass through the needle 150 and into the hollow interior of the reservoir 110. For example, one end of the needle 150 may be in the reservoir 110, and another end of the needle 150 may be in a vial (not shown in FIG. 7B) or other container that stores the fluidic medium, and the fluidic medium may pass from the vial to the reservoir 110 through the needle 150. In some embodiments, the needle 150 is part of a transfer guard or other similar device. Because an amount of air in the reservoir 110 was limited prior to filling the reservoir 110, an amount of air bubbles in the fluidic medium is also limited when the fluidic medium is filled into the reservoir 110. Limiting or reducing a presence of air bubbles in the fluidic medium is beneficial, because it limits an amount of air bubbles that are later expelled from the reservoir 110 into a patient or user, and thus helps to improve a delivery accuracy when delivering a specified amount of the fluidic medium to a user.

[0134] With reference to FIGS. 7A, 7B, and 8, the method of FIG. 8 may then continue to S15 in which the needle 150 is removed from the reservoir 110. In various embodiments, the septum 140 is a self-healing septum, and when the needle 150 is removed from the reservoir 110 and the septum 140, the septum 140 closes such that the fluidic medium is contained within the reservoir 110. The method may then continue to S16. In S16, the septum 140 of the reservoir 110 is pierced with another needle. For example, the septum 140 of the reservoir 110 may be pierced with a needle of a connector of an infusion path, such as a needle of the connector 56 (refer to FIG. 2) of the infusion path 50 (refer to FIG.
2). The method then continues to S17.

[0135] In S17, the plunger head 120 is advanced within the reservoir 110 until at least a portion of the another needle is received within the cavity of the plunger head 120, so as to expel the fluidic medium from the reservoir 110 through the another needle.
FIG. 7A
illustrates the system 100 when the plunger head 120 has been substantially fully advanced within the reservoir 110. When the plunger head 120 is advanced within the reservoir 110, the close fitting contour of the plunger head 120 to the interior surface of the reservoir 110 limits or reduces a volume of wasted fluidic medium that remains in the reservoir 110.
Thus, by having a plunger head 120 with a plunger neck portion 122 that is shaped to very closely fit within the neck portion 112 of the reservoir 110 when the plunger head 120 is fully advanced, a presence of air bubbles in a fluidic medium may be limited during filling of the reservoir 110, and a volume of wasted fluidic medium may be reduced when the fluidic medium is expelled from the reservoir 110. The method then ends in S18.

[0136] FIG. 7C illustrates a cross-sectional view from a front direction of the plunger neck portion 122 of the plunger head 120 in accordance with an embodiment of the present invention. The plunger neck portion 122 includes the cavity 124 for accommodating a needle. In various embodiments, the cavity 124 is positioned substantially near a center of a face of the plunger neck portion 122. FIG. 7D illustrates a side view of the plunger head 120 in accordance with an embodiment of the present invention. The plunger head 120 includes the plunger body portion 121, the plunger neck portion 122, and the plunger sloped portion 123. In various embodiments, the plunger body portion 121 includes one or more depressions or cavities 126 in which the one or more 0-rings 125 (refer to FIG. 7A) may be placed.

[0137] FIGS. 9A, 10A, 11A, 12A, and 12C illustrate systems in accordance with various embodiments of the present invention that include reservoirs with geometries that allow for capturing air bubbles so as to reduce a number of air bubbles that are delivered with a fluidic medium. Such systems allow for air bubble management since they have bubble trapping shapes and, by reducing a number of air bubbles that are delivered with a fluidic medium, such systems may be able to improve a delivery accuracy when attempting to deliver a specified volume of the fluidic medium. Thus, such systems provide reservoir geometries that allow for capturing a greater amount of air bubbles than with standard reservoir geometries, so that the captured air bubbles remain in the reservoir and are not dispensed with the fluidic medium.

[0138] In some embodiments, the systems in FIGS. 9A, 10A, 11A, 12A, and 12C
may include similar elements as elements of embodiments of the delivery device 12 (refer to FIGS. 2 and 3), in which case the reservoirs in those systems would correspond to the reservoir 40 (refer to FIGS. 2, 3, and 6C). In various embodiments, reservoirs of the systems in FIGS. 9A, 10A, 11A, 12A, and 12C may be made of a material, such as but not limited to a suitable metal, plastic, ceramic, glass, composite material, or the like. In various embodiments, the plunger heads of the systems in those figures may be made of a suitably rigid material such as, but not limited to, metal, plastic, ceramic, glass, composite material, or the like. In various other embodiments, the plunger heads in those systems may be made of a compressible material such as, but not limited to, an elastically compressible plastic, rubber, silicone, or the like.

[0139] FIG. 9A illustrates a cross-sectional view of a system 200 in accordance with an embodiment of the present invention. The system 200 includes a reservoir 210, a plunger head 220, and a plunger arm 230. The reservoir 210 includes a body portion 211, a bubble trap portion 212, and a port 217. The reservoir 210 has an outer surface 213 and an inner surface 214. The inner surface 214 of the reservoir 210 defines a hollow interior of the reservoir 210, and the hollow interior of the reservoir 210 is able to contain a fluidic medium. The port 217 of the reservoir 210 allows for the fluidic medium to be filled into or expelled from the hollow interior of the reservoir 210. The body portion 211 of the reservoir 210 may have any suitable shape, such as but not limited to, a cylinder shape, a tube shape, a barrel shape, a spherical shape, a shape with a rectangular cross-section, or the like.

[0140] The plunger head 220 is located within the reservoir 210, and is moveable in an axial direction of the reservoir 210, to expand or contract a volume of the reservoir 210 in which a fluidic medium may be contained. The plunger head 220 is connected to the plunger arm 230, such that movement of the plunger arm 230 in the axial direction of the reservoir 210 causes movement of the plunger head 220 in the axial direction of the reservoir 210. The plunger head 220 includes a plunger body portion 221 and a plunger protruding portion 222. In various embodiments, the plunger head 220 further includes one or more 0-rings 225 that surround a portion of the plunger body portion 221.
In various embodiments, the one or more 0-rings 225 may be made of any suitable material, such as but not limited to, rubber, plastic, composite material, or the like.

[0141] The bubble trap portion 212 of the reservoir 210 is shaped to have a volume 216 within an interior of the reservoir 210, such that air bubbles in a fluidic medium may be trapped in the volume 216 when the fluidic medium is expelled from the reservoir 210 through the port 217. In various embodiments, an interior surface of the bubble trap portion 212 is curved or angled near the port 217, so as to define the volume 216. In some embodiments, the bubble trap portion 212 extends from the body portion 211 of the reservoir 210 past a point 218 of the reservoir 210 where a fluidic medium from an interior volume of the body portion 211 is able to move into an area or channel 272 of the reservoir 210 that leads to the port 217.

[0142] In various embodiments, the reservoir 210 is shaped such that as the plunger head 220 is advanced within the reservoir 210, a fluidic medium is able to pass through the port 217 while air bubbles in the reservoir 210 collect in the volume 216 defined by a curved or angled surface of the bubble trap portion 212 of the reservoir 210. Such a geometry of the reservoir 210 allows for decreasing an amount of air bubbles that are delivered with a fluidic medium as compared with traditional reservoir geometries. In some embodiments, the bubble trap portion 212 of the reservoir 210 is curved outward from an interior volume defined by the body portion 211, and a fluidic medium is able to pass directly from the interior volume defined by the body portion 211 to the port 217. In some embodiments, a surface 215 of the bubble trap portion 212 of the reservoir 210 includes a surface finish or material such that air bubbles substantially do no stick to the surface 215 and are shunted away from the port 217 toward the volume 216. In various embodiments, such a surface finish or material includes a hydrophobic material, a hydrophilic material, or other suitable material.

[0143] The plunger body portion 221 is shaped such that a contour of the plunger body portion 221 substantially matches or is substantially the same as an inner contour of the body portion 211 of the reservoir 210. In various embodiments, the plunger body portion 221 has a diameter that is slightly smaller than a diameter of the inner surface of the body portion 211 of the reservoir 210, such that the plunger head 220 is able to slide within the reservoir 210. In some embodiments, an 0-ring 225 on the plunger body portion 221 is in contact with the inner surface of the body portion 211 of the reservoir 210 when the plunger head 220 is within the reservoir 210.

[0144] In various embodiments, the plunger protruding portion 222 is shaped such that a contour of the plunger protruding portion 222 substantially matches or is substantially the same as an inner contour of the bubble trap portion 212 of the reservoir 210.
In some embodiments, the plunger protruding portion 222 is curved and protrudes from the plunger body portion 221. In various embodiments, the plunger protruding portion 222 has a size that is slightly smaller than a region defined by the inner surface of the bubble trap portion 212 of the reservoir 210, such that the plunger protruding portion 222 is able to slide within the volume 216 of the reservoir 210, and such that a space for a dead volume of air is left when the plunger head 220 is fully advanced within the reservoir 210. Thus, in various embodiments, the geometry of the reservoir 210 and the plunger head 220 allow for capturing air bubbles in a volume 216 of the bubble trap portion 212 when a fluidic medium is being expelled from the port 217 of the reservoir 210.

[0145] In various embodiments, the plunger protruding portion 222 has a size such that when the plunger head 220 is fully advanced within the reservoir 210, the plunger protruding portion 222 fills at least 80% of the volume 216 of the bubble trap portion 212.
Also, in various embodiments, the plunger protruding portion 222 fills less than 98% of the volume 216 of the bubble trap portion 212 when the plunger head 220 is fully advanced within the reservoir 210, so that one or more air pockets for holding air exist between the plunger protruding portion 222 and an inner surface of the bubble trap portion 212 when the plunger head 220 is fully advanced within the reservoir 210. In some embodiments, the plunger protruding portion 222 extends at least partially into the volume 216 of the bubble trap portion 212 when the plunger head 220 is sufficiently advanced within the reservoir 210.

[0146] FIG. 9B illustrates a cross-sectional view of the reservoir 210 in accordance with an embodiment of the present invention. FIG. 9B is shaded to highlight various features of the reservoir 210. The reservoir 210 includes the body portion 211, the bubble trap portion 212, and the port 217. The body portion 211 has an interior volume 270 for containing a fluidic medium. The port 217 is in fluid flow communication with the interior volume 270 of the body portion 211. The bubble trap portion 212 has the volume 216 in fluid flow communication with the interior volume 270 of the body portion 211 for trapping air bubbles that are in the fluidic medium as the fluidic medium is being expelled from the interior volume 270.

[0147] In various embodiments, the port 217 is located to a particular side of the interior volume 270, and the bubble trap portion 212 is located to the particular side of the interior volume 270. Also, in various embodiments, the bubble trap portion 212 has a first portion 281 that extends from the body portion 211 away from the interior volume 270, and a second portion 282 that returns back toward the interior volume 270. In some embodiments, the body portion 211 and the bubble trap portion 212 are formed together as a single seamless unit. Also, in some embodiments, the first portion 281 of the bubble trap portion 212 extends from the body portion 211 away from the interior volume 270 and the second portion 282 of the bubble trap portion 212 extends from the first portion 281 toward the interior volume 270.

[0148] In various embodiments, the bubble trap portion 212 includes a curved surface 283 having a first end region 284, a second end region 285, and a middle region 286 between the first end region 284 and the second end region 285. In some embodiments, the first end region 284 and the second end region 285 are closer to the interior volume 270 of the body portion 211 than the middle region 286 is to the interior volume 270. Also, in some embodiments, the first end region 284 is in contact with the body portion 211, and the second end region 285 is located adjacent to the interior volume 270 of the body portion 211.

[0149] In various embodiments, the curved surface 283 of the bubble trap portion 212 is in contact with the fluidic medium when the fluidic medium is in the volume 216 of the bubble trap portion 212. In further embodiments, the curved surface 283 is approximately U-shaped. FIG. 9B illustrates a cross-sectional view, but in three-dimensions the bubble trap portion 212 may be shaped, for example, approximately as a semi-toroid. In various embodiments, the reservoir 210 is shaped such that in order for a fluidic medium to flow from the volume 216 of the bubble trap portion 212 to the port 217, the fluidic medium must flow through the interior volume 270 of the body portion 211. In some embodiments, the reservoir 210 includes the channel 272 that leads from the interior volume 270 of the body portion 211 to the port 217, and the bubble trap portion 212 encircles at least a portion of the channel 272.

[0150] FIG. 10A illustrates a cross-sectional view of a system 300 in accordance with an embodiment of the present invention. The system 300 includes a reservoir 310, a plunger head 320, and a plunger arm 330. The reservoir 310 includes a body portion 311, a bubble trap portion 312, and a port 317. The reservoir 310 has an outer surface 313 and an inner surface 314. The inner surface 314 of the reservoir 310 defines a hollow interior of the reservoir 310, and the hollow interior of the reservoir 310 is able to contain a fluidic medium. The port 317 of the reservoir 310 allows for the fluidic medium to be filled into or expelled from the hollow interior of the reservoir 310. The body portion 311 of the reservoir 310 may have any suitable shape, such as but not limited to, a cylinder shape, a tube shape, a barrel shape, a spherical shape, a shape with a rectangular cross-section, or the like.

[0151] The plunger head 320 is located within the reservoir 310, and is moveable in an axial direction of the reservoir 310, to expand or contract a volume of the reservoir 310 in which a fluidic medium may be contained. The plunger head 320 is connected to the plunger arm 330, such that movement of the plunger arm 330 in the axial direction of the reservoir 310 causes movement of the plunger head 320 in the axial direction of the reservoir 310. The plunger head 320 includes a plunger body portion 321 and a plunger protruding portion 322. In various embodiments, the plunger head 320 further includes one or more 0-rings 325 that surround a portion of the plunger body portion 321.

[0152] The bubble trap portion 312 of the reservoir 310 is shaped so as to form a volume 316 within an interior of the reservoir 310, such that air bubbles in a fluidic medium may be trapped in the volume 316 of the bubble trap portion 312 when the fluidic medium is expelled from the reservoir 310 through the port 317. In various embodiments, an interior surface of the bubble trap portion 312 is angled at a substantially straight angle near the port 317, so as to define the volume 316. In some embodiments, the bubble trap portion 312 extends from the body portion 311 of the reservoir 310 past a point 318 of the reservoir 310 where a fluidic medium from an interior volume of the body portion 311 is able to move into an area or channel 372 of the reservoir 310 that leads to the port 317.

[0153] In various embodiments, the reservoir 310 is shaped such that as the plunger head 320 is advanced within the reservoir 310, a fluidic medium is able to pass through the port 317 while air bubbles in the reservoir 310 collect in the volume 316 defined by a substantially straight angled surface of the bubble trap portion 312 of the reservoir 310.
Such a geometry of the reservoir 310 may allow for decreasing an amount of air bubbles that are delivered with a fluidic medium as compared with traditional reservoir geometries. In some embodiments, the bubble trap portion 312 of the reservoir 310 is angled outward from an interior region of the reservoir 310 defined by the body portion 311, and a fluidic medium is able to pass directly from the interior region of the reservoir 310 defined by the body portion 311 to the port 317. In some embodiments, a surface 315 of the bubble trap portion 312 of the reservoir 310 includes a surface finish or material such that air bubbles substantially do no stick to the surface 315 and are shunted away from the port 317 toward the volume 316.

[0154] The plunger body portion 321 is shaped such that a contour of the plunger body portion 321 substantially matches or is substantially the same as a contour of an inner surface of the body portion 311 of the reservoir 310. In various embodiments, the plunger body portion 321 has a diameter that is slightly smaller than a diameter of the inner surface of the body portion 311 of the reservoir 310, such that the plunger head 320 is able to slide within the reservoir 310. In some embodiments, the one or more 0-rings 325 on the plunger body portion 321 are in contact with the inner surface of the body portion 311 of the reservoir 310 when the plunger head 320 is within the reservoir 310.

[0155] In various embodiments, the plunger protruding portion 322 is shaped such that a contour of the plunger protruding portion 322 substantially matches or is substantially the same as an inner contour of the bubble trap portion 312 of the reservoir 310.
In some embodiments, the plunger protruding portion 322 is angled from the plunger body portion 321 at a substantially straight angle and protrudes from the plunger body portion 321. In various embodiments, the plunger protruding portion 322 has a size that is slightly smaller than a region defined by the inner surface of the bubble trap portion 312 of the reservoir 310, such that the plunger protruding portion 322 is able to slide within the volume 316 of the bubble trap portion 312, and such that a space for a dead volume of air is left when the plunger head 320 is fully advanced within the reservoir 310. Thus, in various embodiments, the geometry of the reservoir 310 and the plunger head 320 allow for capturing air bubbles in a volume 316 of the bubble trap portion 312 when a fluidic medium is being expelled from the port 317 of the reservoir 310.

[0156] In various embodiments, the plunger protruding portion 322 has a size such that when the plunger head 320 is fully advanced within the reservoir 310, the plunger protruding portion 322 fills at least 80% of the volume 316 of the bubble trap portion 312.
Also, in various embodiments, the plunger protruding portion 322 fills less than 98% of the volume 316 of the bubble trap portion 312 when the plunger head 320 is fully advanced within the reservoir 310, so that one or more air pockets for holding air exist between the plunger protruding portion 322 and an inner surface of the bubble trap portion 312 when the plunger head 320 is fully advanced within the reservoir 310. In some embodiments, the plunger protruding portion 322 extends at least partially into the volume 316 of the bubble trap portion 312 when the plunger head 320 is sufficiently advanced within the reservoir 310.

[0157] FIG. 10B illustrates a cross-sectional view of the reservoir 310 in accordance with an embodiment of the present invention. FIG. 10B is shaded to highlight various features of the reservoir 310. The reservoir 310 includes the body portion 311, the bubble trap portion 312, and the port 317. The body portion 311 has an interior volume 370 for containing a fluidic medium. The port 317 is in fluid flow communication with the interior volume 370 of the body portion 311. The bubble trap portion 312 has the volume 316 in fluid flow communication with the interior volume 370 of the body portion 311 for trapping air bubbles that are in the fluidic medium as the fluidic medium is being expelled from the interior volume 370.

[0158] In various embodiments, the port 317 is located to a particular side of the interior volume 370, and the bubble trap portion 312 is located to the particular side of the interior volume 370. Also, in various embodiments, the bubble trap portion 312 has a first portion 381 that extends from the body portion 311 away from the interior volume 370, and a second portion 382 that returns back toward the interior volume 370. In some embodiments, the body portion 311 and the bubble trap portion 312 are formed together as a single seamless unit. Also, in some embodiments, the first portion 381 of the bubble trap portion 312 extends from the body portion 311 away from the interior volume 370 and the second portion 382 of the bubble trap portion 312 extends from the first portion 381 toward the interior volume 370.

[0159] In various embodiments, the reservoir 310 is shaped such that in order for a fluidic medium to flow from the volume 316 of the bubble trap portion 312 to the port 317, the fluidic medium must flow through the interior volume 370 of the body portion 311. In some embodiments, the reservoir 310 includes the channel 372 that leads from the interior volume 370 of the body portion 311 to the port 317, and the bubble trap portion 312 encircles at least a portion of the channel 372.

[0160] In various embodiments, the bubble trap portion 312 includes a first surface 383 that defines an edge of the volume 316 of the bubble trap portion 312, and a second surface 384 that defines another edge of the volume 316 of the bubble trap portion 312, where the second surface 384 is positioned at an angle with respect to the first surface 383. In some embodiments, the angle between the first surface 383 and the second surface 384 is less than 90 degrees. Also, in some embodiments, the first surface 383 is planar with respect to an inner surface of the body portion 311 of the reservoir 310. In various embodiments, the port 317 is located to a particular side of the interior volume 370 and the first portion 381 of the bubble trap portion 312 extends from the body portion 311 to the particular side.

[0161] FIG. 11A illustrates a cross-sectional view of a system 400 in accordance with an embodiment of the present invention. The system 400 includes a reservoir 410, a plunger head 420, and a plunger arm 430. The reservoir 410 includes a body portion 411, a bubble trap portion 412, and a port 417. The reservoir 410 has an outer surface 413 and an inner surface 414. The inner surface 414 of the reservoir 410 defines a hollow interior of the reservoir 410, and the hollow interior of the reservoir 410 is able to contain a fluidic medium. The port 417 of the reservoir 410 allows for the fluidic medium to be filled into or expelled from the hollow interior of the reservoir 410. The body portion 411 of the reservoir 410 may have any suitable shape, such as but not limited to, a cylinder shape, a tube shape, a barrel shape, a spherical shape, a shape with a rectangular cross-section, or the like.

[0162] The plunger head 420 is located within the reservoir 410, and is moveable in an axial direction of the reservoir 410, to expand or contract a volume of the reservoir 410 in which a fluidic medium may be contained. The plunger head 420 is connected to the plunger arm 430, such that movement of the plunger arm 430 in the axial direction of the reservoir 410 causes movement of the plunger head 420 in the axial direction of the reservoir 410. The plunger head 420 includes a plunger body portion 421 and a plunger protruding portion 422. In various embodiments, the plunger head 420 further includes one or more 0-rings 425 that surround a portion of the plunger body portion 421.

[0163] The bubble trap portion 412 of the reservoir 410 is shaped so as to form a volume 416 within an interior of the reservoir 410, such that air bubbles in a fluidic medium may be trapped in the volume 416 of the bubble trap portion 412 when the fluidic medium is expelled from the reservoir 410 through the port 417. In various embodiments, the reservoir 410 is shaped such that as the plunger head 420 is advanced within the reservoir 410, a fluidic medium is able to pass through the port 417 while air bubbles in the reservoir 410 collect in the volume 416 of the reservoir 410. Such a geometry of the reservoir 410 may allow for decreasing an amount of air bubbles that are delivered with a fluidic medium as compared with traditional reservoir geometries.

[0164] The plunger body portion 421 is shaped such that a contour of an outer surface of the plunger body portion 421 substantially matches or is substantially the same as a contour of an inner surface of the body portion 411 of the reservoir 410. In various embodiments, the plunger body portion 421 has a diameter that is slightly smaller than a diameter of the inner surface of the body portion 411 of the reservoir 410, such that the plunger head 420 is able to slide within the reservoir 410. In some embodiments, the one or more 0-rings 425 on the plunger body portion 421 are in contact with the inner surface of the body portion 411 of the reservoir 410 when the plunger head 420 is within the reservoir 410. In various embodiments, the plunger protruding portion 422 is shaped such that a contour of an outer surface of the plunger protruding portion 422 substantially matches or is substantially the same as a contour of an inner surface of the bubble trap portion 412 of the reservoir 410.

[0165] FIG. 11B illustrates a cross-sectional view of the reservoir 410 in accordance with an embodiment of the present invention. FIG. 11B is shaded to highlight various features of the reservoir 410. The reservoir 410 includes the body portion 411, the bubble trap portion 412, and the port 417. The body portion 411 has an interior volume 470 for containing a fluidic medium. The port 417 is in fluid flow communication with the interior volume 470 of the body portion 411. The bubble trap portion 412 has the volume 416 in fluid flow communication with the interior volume 470 of the body portion 411 for trapping air bubbles that are in the fluidic medium as the fluidic medium is being expelled from the interior volume 470.

[0166] In various embodiments, the port 417 is located to a particular side of the interior volume 470, and the bubble trap portion 412 is located to the particular side of the interior volume 470. Also, in various embodiments, the bubble trap portion 412 has a first portion 481 that extends from the body portion 411 away from the interior volume 470, and a second portion 482 that returns back toward the interior volume 470. In some embodiments, the body portion 411 and the bubble trap portion 412 are formed together as a single seamless unit. Also, in some embodiments, the first portion 481 of the bubble trap portion 412 extends from the body portion 411 away from the interior volume 470 and the second portion 482 of the bubble trap portion 412 extends from the first portion 481 toward the interior volume 470.

[0167] In various embodiments, the bubble trap portion 412 includes a curved surface 483.
In some embodiments, the curved surface 483 of the bubble trap portion 412 is in contact with the fluidic medium when the fluidic medium is in the volume 416 of the bubble trap portion 412. In various embodiments, the reservoir 410 is shaped such that in order for a fluidic medium to flow from the volume 416 of the bubble trap portion 412 to the port 417, the fluidic medium must flow through the interior volume 470 of the body portion 411. In some embodiments, the reservoir 410 includes a channel 472 that leads from the interior volume 470 of the body portion 411 to the port 417, and the bubble trap portion 412 encircles at least a portion of the channel 472.

[0168] With reference to FIGS. 11A and 11B, in various embodiments, the plunger protruding portion 422 is shaped such that a contour of the plunger protruding portion 422 substantially matches or is substantially the same as an inner contour of the bubble trap portion 412 of the reservoir 410. In some embodiments, the plunger protruding portion 422 is at least partially curved and protrudes from the plunger body portion 421.
Also, in some embodiments, the plunger protruding porting includes a surface that is substantially parallel to an inner surface of the body portion 411 of the reservoir 410. In various embodiments, the plunger protruding portion 422 has a size that is slightly smaller than a region defined by the inner surface of the bubble trap portion 412 of the reservoir 410, such that the plunger protruding portion 422 is able to slide within the volume 416 of the reservoir 410, and such that a space for a dead volume of air is left when the plunger head 420 is fully advanced within the reservoir 410. Thus, in various embodiments, the geometry of the reservoir 410 and the plunger head 420 allow for capturing air bubbles in a volume 416 of the bubble trap portion 412 when a fluidic medium is being expelled from the port 417 of the reservoir 410.

[0169] In various embodiments, the plunger protruding portion 422 has a size such that when the plunger head 420 is fully advanced within the reservoir 410, the plunger protruding portion 422 fills at least 80% of the volume 416 of the bubble trap portion 412.
Also, in various embodiments, the plunger protruding portion 422 fills less than 98% of the volume 416 of the bubble trap portion 412 when the plunger head 420 is fully advanced within the reservoir 410, so that one or more air pockets for holding air exist between the plunger protruding portion 422 and an inner surface of the bubble trap portion 412 when the plunger head 420 is fully advanced within the reservoir 410. In some embodiments, the plunger protruding portion 422 extends at least partially into the volume 416 of the bubble trap portion 412 when the plunger head 420 is sufficiently advanced within the reservoir 410.

[0170] FIG. 12A illustrates a cross-sectional view of a system 500 in accordance with an embodiment of the present invention. The system 500 includes a reservoir 510, a plunger head 520, and a plunger arm 530. In various embodiments, the system 500 further includes a needle 550. The reservoir 510 is similar to the reservoir 210 of the system 200 (refer to FIG. 9A), and includes a body portion 511 and a bubble trap portion 512. The bubble trap portion 512 defines a volume 516 for trapping air bubbles. Thus, the reservoir 510 has an air trap geometry that allows for capturing air bubbles.

[0171] The plunger head 520 is similar to the plunger head 220 of the system 200 (refer to FIG. 9A). The plunger head 520 includes a plunger body portion 521 and a plunger protruding portion 522. The plunger head 520 further includes a depression or relief 523 for allowing at least a portion of the needle 550 to be inserted into an interior of the reservoir 510 when the plunger head 520 is fully advanced within the reservoir 510. In various embodiments, the plunger head 520 has the relief 523 for receiving at least a portion of the needle 550 when the plunger head 520 is sufficiently advanced within the reservoir 510 and the portion of the needle 550 is inserted into the reservoir 510. In various embodiments, the reservoir 510 is shaped to trap air bubbles. Also, in various embodiments, the reservoir 510 and the plunger head 520 are shaped so as to minimize a delivery of air bubbles when a fluidic medium is expelled from the reservoir 510.

[0172] FIG. 12B illustrates a cross-sectional view of the reservoir 510 in accordance with an embodiment of the present invention. FIG. 12B is shaded to highlight various features of the reservoir 510. The reservoir 510 includes the body portion 511, the bubble trap portion 512, and a port 517. The body portion 511 has an interior volume 570 for containing a fluidic medium. The port 517 is in fluid flow communication with the interior volume 570 of the body portion 511. The bubble trap portion 512 has the volume 516 in fluid flow communication with the interior volume 570 of the body portion 511 for trapping air bubbles that are in the fluidic medium as the fluidic medium is being expelled from the interior volume 570.

[0173] In various embodiments, the port 517 is located to a particular side of the interior volume 570, and the bubble trap portion 512 is located to the particular side of the interior volume 570. Also, in various embodiments, the bubble trap portion 512 has a first portion 581 that extends from the body portion 511 away from the interior volume 570, and a second portion 582 that returns back toward the interior volume 570. In some embodiments, the body portion 511 and the bubble trap portion 512 are formed together as a single seamless unit. Also, in some embodiments, the first portion 581 of the bubble trap portion 512 extends from the body portion 511 away from the interior volume 570 and the second portion 582 of the bubble trap portion 512 extends from the first portion 581 toward the interior volume 570.

[0174] In various embodiments, the bubble trap portion 512 includes a curved surface 583 having a first end region 584, a second end region 585, and a middle region 586 between the first end region 584 and the second end region 585. In some embodiments, the first end region 584 and the second end region 585 are closer to the interior volume 570 of the body portion 511 than the middle region 586 is to the interior volume 570. Also, in some embodiments, the first end region 584 is in contact with the body portion 511, and the second end region 585 is located adjacent to the interior volume 570 of the body portion 511.

[0175] In various embodiments, the curved surface 583 of the bubble trap portion 512 is in contact with the fluidic medium when the fluidic medium is in the volume 516 of the bubble trap portion 512. In further embodiments, the curved surface 583 is approximately U-shaped. FIG. 9B illustrates a cross-sectional view, but in three-dimensions the bubble trap portion 512 may be shaped, for example, approximately as a semi-toroid. In various embodiments, the reservoir 510 is shaped such that in order for a fluidic medium to flow from the volume 516 of the bubble trap portion 512 to the port 517, the fluidic medium must flow through the interior volume 570 of the body portion 511. In some embodiments, the reservoir 510 includes a channel 572 that leads from the interior volume 570 of the body portion 511 to the port 517, and the bubble trap portion 512 encircles at least a portion of the channel 572.

[0176] FIG. 12C illustrates a cross-sectional view of the system 500 of FIG.
12A in accordance with another embodiment of the present invention. In the embodiment illustrated in FIG. 12C, the system 500 further includes a plug 560. In various embodiments, the plug 560 is located between an interior surface 515 of the bubble trap portion 512 of the reservoir 510 and a location of the reservoir where a fluidic medium is able to be expelled from the reservoir. The plug 560 may comprise, for example, a hydrophilic material or a hydrophobic material, that will substantially keep air bubbles from being dispensed through a port 517 of the reservoir 510. As a consequence, a delivery accuracy may be able to be improved since a number of air bubbles expelled from the reservoir 510 is further limited by the plug 560. In various embodiments, the plug 560 shunts air bubbles in a fluidic medium away from the port 517 of the reservoir 510 and toward the volume 516 of the bubble trap portion 512 when the fluidic medium is being expelled from an interior volume of the body portion 511 of the reservoir 510.

[0177] FIG. 13A illustrates a cross-sectional view of a system 600 in accordance with an embodiment of the present invention. The system 600 includes a reservoir 610, a plunger head 620, a plunger arm 630, a transfer guard 640, a vial 650, and a vibrating apparatus 670.
The vial 650 allows for containing a fluidic medium, and the vial 650 includes a vial septum 652 that is able to be pierced by a needle. The transfer guard 640 includes a needle 642 for transferring a fluidic medium. The reservoir 610 includes a septum 614 that is able to be pierced by a needle, such as the needle 642. The vibrating apparatus 670 includes a holding unit 675 and a vibrator 677. In various embodiments, the vibrating apparatus 670 further includes one or more supports 673, one or more latches 674, and a power source 678. The power source 678 may comprise, for example, an electrical plug for plugging the vibrator 677 into an electrical socket, a battery for powering the vibrator 677, or the like. In various embodiments, the vibrator 677 is an electric vibrator, or the like.

[0178] The holding unit 675 allows for holding the reservoir 610. In various embodiments, the holding unit 675 includes a first holder 671 and a second holder 672 for holding the reservoir 610. The holding unit 675 is configured such that the plunger arm 630 that is connected to the plunger head 620 that is within the reservoir 610 is moveable when the holding unit 675 is holding the reservoir 610 and the reservoir 610 is being filled with a fluidic medium. The vibrator 677 allows for vibrating the holding unit 675 so as to vibrate the reservoir 610. In various embodiments, the vibrator 677 is configured to vibrate the holding unit 675 when the holding unit 675 is holding the reservoir 610 and the reservoir 610 is being filled with the fluidic medium, so as to vibrate the reservoir 610 and cause air bubbles within the fluidic medium to travel upwards within the reservoir 610.
Also, in various embodiments, the vibrator 677 is configured to shake the holding unit sufficiently when the holding unit 675 is holding the reservoir 610 and the reservoir 610 is being filled with the fluidic medium so as to shake air bubbles free in the fluidic medium.

[0179] In some embodiments, the holding unit 675 includes the first holder 671 and the second holder 672, and the plunger arm 630 is moveable within a space 676 between the first holder 671 and the second holder 672 when the reservoir 610 is being held by the first holder 671 and the second holder 672 and the reservoir 610 is being filled with the fluidic medium. In various embodiments, the first holder 671 and the second holder 672 are connected to the vibrator 677. Also, in various embodiments, the space 676 is also at least partially between the plunger arm 630 and the vibrator 677. In some embodiments, one or both of the first holder 671 and the second holder 672 are attached to the vibrator 677 with hinges (not shown) such that they are able to swing open to allow for placing the reservoir 610 at least partially between the first holder 671 and the second holder 672, and then are able to swing closed and lock so that the reservoir 610 is held tightly between the first holder 671 and the second holder 672. Also, in some embodiments, the holding unit 675 further includes cushions 693 between the first holder 671 and the reservoir 610, and between the second holder 672 and the reservoir 610. In various embodiments, the holding unit 675 is a single member into which the reservoir 610 is able to be inserted and held securely.

[0180] In various embodiments, the holding unit 675 is configured such that, when the holding unit 675 is holding the reservoir 610, the fluidic medium is able to be filled into the reservoir 610 through a port 680 of the reservoir 610 that is located to an opposite side of the plunger head 620 from the plunger arm 630. Also, in various embodiments, the holding unit 675 is configured such that the plunger arm 630 is moveable in a direction toward the vibrator 677 when the holding unit 675 is holding the reservoir 610 and the reservoir 610 is being filled with the fluidic medium. In some embodiments, the vibrating apparatus 670 includes the one or more latches 674, and the one or more latches 674 allow for preventing the plunger arm 630 from being moved when the holding unit 675 is holding the reservoir 610 and prior to a time when the reservoir 610 is being filled with the fluidic medium. In such embodiments, the one or more latches 674 may be controlled to swing open or retract to allow the plunger arm 630 to move within the space 676, so as to allow the reservoir 610 to be filled with the fluidic medium.

[0181] In various embodiments, the system 600 includes the transfer guard 640, and the transfer guard 640 allows for transferring the fluidic medium from the vial 650 to the reservoir 610 when the holding unit 675 is holding the reservoir 610. In some embodiments, the transfer guard 640 includes a first end 647 for at least partially surrounding the port 680 of the reservoir 610 when the needle 642 of the transfer guard 640 pierces the septum 614 in the port 680 of the reservoir 610. In various embodiments, the holding unit 675 is configured such that a handle 632 connected to the plunger arm 630 is moveable within the space 676 between the reservoir 610 and the vibrator 677 when the holding unit 675 is holding the reservoir 610 and the reservoir 610 is being filled with the fluidic medium.

[0182] In some embodiments, the handle 632 is able to be pulled by a user while the vibrator 677 is vibrating the reservoir 610. In various other embodiments, the handle 632 is connected to springs (not shown) to move the handle 632 so as to move the plunger head 620 when the one or more latches 674 are opened. In some embodiments, the system further includes a motor (not shown) for moving the handle 632 to move the plunger head 620 while the holding unit 675 is holding the reservoir 610. Also, in some embodiments, the handle 632 is able to be disconnected from the plunger arm 630, such that the handle 632 may be disconnected from the plunger arm 630 after the reservoir 610 has been filled with the fluidic medium. In various embodiments, the vibrating apparatus 670 includes the one or more supports 673 for supporting the holding unit 675, where the one or more supports 673 may be attached to a stand (not shown), or the like.

[0183] During a filling process, the needle 642 of the transfer guard 640 establishes a fluid path between the vial 650 and the reservoir 610. The one or more latches 674 are released to allow fluid to flow into the reservoir 610. While the reservoir 610 is filling with the fluidic medium, the vibrator 677 may vibrate the reservoir 610 such that air bubbles in the fluidic medium travel upwards within the reservoir 610. Thus, in various embodiments, the vibrator 677 allows for shaking the reservoir 610 so as to shake bubbles free in a fluidic medium being filled into the reservoir 610. In various embodiments, once the filling process has completed in the system 600, the vial 650 is disconnected from the transfer guard 640, and air in the reservoir 610 is pushed out by pressing on the handle 632.

[0184] FIG. 14 illustrates a flowchart for a method in accordance with an embodiment of the present invention. With reference to FIGS. 13A and 14, in S20 the reservoir 610 is held with the holding unit 675. The method then continues to S21. In S21, the septum 614 located within the port 680 of the reservoir 610 is pierced with the needle 642 of the transfer guard 640 to allow the fluidic medium to be transferred from the vial 650 to the reservoir 610 through the needle 642. The method then continues to S22. In S22, the one or more latches 674 are moved to allow the plunger arm 630 to be moved when the holding unit 675 is holding the reservoir 610. The method then continues to S23.

[0185] In S23, the plunger arm 630 is moved so as to move the plunger head 620 within the reservoir 610 to allow the fluidic medium to fill into the reservoir 610 when the holding unit 675 is holding the reservoir 610. In various embodiments, the moving includes moving the plunger arm 630 toward the vibrator 677 so as to move the plunger head 620 within the reservoir 610 to allow the fluidic medium to fill into the reservoir 610 when the holding unit 675 is holding the reservoir 610 (S24). FIG. 13B illustrates a cross-sectional view of the system 600 in accordance with an embodiment of the present invention when the plunger arm 630 has been moved to allow the fluidic medium to fill into the reservoir 610 when the holding unit 675 is holding the reservoir 610. The method of FIG. 14 then continues to S25.

[0186] With reference to FIGS. 13A, 13B, and 14, in S25 the vibrator 677 vibrates the holding unit 675 so as to vibrate the reservoir 610. In various embodiments, the vibrating includes vibrating the holding unit 675 with the vibrator 677 when the holding unit 675 is holding the reservoir 610 and the reservoir 610 is being filled with the fluidic medium (S26).
Also, in various embodiments, the vibrating includes vibrating the holding unit 675 with the vibrator 677 so as to vibrate the reservoir 610 to cause air bubbles within the fluidic medium to travel upwards within the reservoir 610 (S27). The method then continues to S28. In S28, air is pushed out of the reservoir 610 after the reservoir 610 has been vibrated. For example, the vial 650 may be removed from the transfer guard 640, and the handle 632 may be pushed to push air out of the reservoir 610. The method then ends in S29.

[0187] FIG. 15 illustrates a cross-sectional view of a system 3500 in accordance with an embodiment of the present invention. The system 3500 includes a reservoir 3510, a plunger head 3520, a plunger arm 3530, a septum 3540, one or more hydrophobic filters 3571, and one or more air passages 3572. The reservoir 3510 has a hollow interior for containing a fluidic medium. The plunger head 3520 is located within the reservoir 3510 and is moveable in an axial direction of the reservoir 3510, to expand or contract an interior volume of the reservoir 3510. The reservoir includes a neck portion 3512. The septum 3540 is located at an end of the neck portion 3512 of the reservoir 3510, and a fluid channel 3550 is defined in the neck portion 3512 of the reservoir 3510 extending from the septum 3540.

[0188] The one or more air passages 3572 extend from within the reservoir 3510 to a same outer surface of the reservoir 3510 through which a fluidic medium is expelled from the reservoir 3510. In various embodiments, the one or more air passages 3572 surround the fluid channel 3550. The one or more hydrophobic filters 3571 are located at ends of the one or more air passages 3572 within the reservoir 3510. The hydrophobic filters 3571 comprise hydrophobic material that substantially prevents a fluidic medium in the reservoir 3510 from entering the one or more air passages 3572. The one or more air passages 3572 allow for air in the reservoir to pass through the one or more hydrophobic filters 3571 and to exit the reservoir 3510.

[0189] A method in accordance with the present invention allows for expelling a fluidic medium from the reservoir 3510. In a first step of the method, a fluid path is established through the septum 3540 to the fluid channel 3550. In a second step of the method, the plunger head 3520 is depressed within the reservoir 3510, such that the fluidic medium is expelled through the fluid channel 3550 and out of the reservoir 3510 through the septum 3540. When the fluidic medium is being expelled through the fluid channel 3550, air in the reservoir 3510 is able to pass through the one or more hydrophobic filters 3571 and out of the reservoir through the one or more air passages 3572. The fluidic medium is substantially prevented from entering the one or more air passages 3572 by the one or more hydrophobic filters 3571. Thus, in accordance with the method, the fluidic medium is able to be expelled from the reservoir 3510 while air in the reservoir 3510 is able to escape through the one or more air passages 3572 that exit the reservoir 3510 on a same side of the reservoir 3510 that the fluidic medium exits the reservoir 3510.

[0190] FIG. 16A illustrates a cross-sectional view of a system 3600 in accordance with an embodiment of the present invention. The system 3600 includes a reservoir 3610, a plunger head 3620, a plunger arm 3630, a transfer guard 3640, a vial 3650, and a pressure providing device 3660. The reservoir 3610 has a hollow interior for containing a fluidic medium. The plunger head 3620 is located within the reservoir 3610 and is moveable in an axial direction of the reservoir 3610, to expand or contract an interior volume of the reservoir 3610. The plunger arm 3630 is connected to the plunger head 3620. In various embodiments, the reservoir 3610 includes a septum 3618 that is able to be pierced by a needle, such that the hollow interior of the reservoir 3610 is able to be filled with a fluidic medium that passes through the needle once the needle has pierced the septum 3618.

[0191] The vial 3650 includes a diaphragm 3653 that is connected to an inner surface 3651 of the vial 3650. The inner surface 3651 of the vial 3650 and an outer surface of the diaphragm 3653 define an interior volume of the vial 3650 that is able to contain a fluidic medium. In various embodiments, the diaphragm 3653 comprises rubber, plastic, or the like, and is flexible. In some embodiments, the vial 3650 further includes a septum 3654 that is able to be pierced by a needle, such that a fluidic medium is able to be expelled from the vial 3650 through the needle once the needle has pierced the septum 3654.
In various embodiments, the vial 3650 includes a bottom surface 3652 with an opening for allowing air or other motivation to enter into the vial 3650 on an opposite side of the diaphragm 3653 from a side of the diaphragm 3653 that is in contact with the fluidic medium in the vial 3650.

[0192] The transfer guard 3640 includes one or more needles 3642 for providing a fluid path from an interior volume of the vial 3650 to an interior volume of the reservoir 3610. In various embodiments, the transfer guard 3640 includes walls that help to shield the one or more needles 3642 from contact with a hand of a user when the user is connecting the vial 3650 and the reservoir 3610 with the transfer guard 3640. The one or more needles 3642 of the transfer guard 3640 are able to pierce the septum 3654 of the vial 3650 and the septum 3618 of the reservoir 3610, so as to provide a fluid path from the vial 3650 to the reservoir 3610. In various embodiments, a membrane may be incorporated into the fluid flow path in the transfer guard 3640 to trap air bubbles as a fluidic medium passes along the fluid flow path from the vial 3650 to the reservoir 3610.

[0193] The pressure providing device 3660 may include, for example, a syringe, or the like, for forcing air or other motivation, such as a fluid, through the opening in the bottom surface 3652 of the vial 3650. In various other embodiments, the pressure providing device 3660 may include, for example, a pump, or the like for providing pressure. The pressure providing device 3660 is connected to the vial 3650 at a connection point 3670 by, for example, an air tight connector, a screw connection, a clamp, or the like. In FIG. 16A, the pressure providing device 3660 is illustrated as a syringe having an inner surface 3661 defining a hollow interior, a plunger head 3662, a plunger arm 3663 connected to the plunger head 3662, and a handle 3664 connected to the plunger arm 3663. The syringe is configured such that air or other motivation is expelled from the syringe when the handle 3664 is pressed to cause the plunger head 3662 to advance within the interior of the syringe.

[0194] A method in accordance with an embodiment of the present invention allows for filling the reservoir 3610 in the system 3600. A first step in the method is to connect the pressure providing device 3660 to one end of the vial 3650 and connect another end of the vial 3650 to the reservoir 3610 using the transfer guard 3640. An example of such a connected structure is illustrated in FIG. 16A. A second step in the method is to use the pressure providing device 3660 to apply pressure to a side of the diaphragm 3653 in the vial 3650 that is opposite a side of diaphragm 3653 that is in contact with a fluidic medium. For example, in a case that the pressure providing device includes a syringe, the handle 3664 is pressed so as to advance the plunger head 3662 within the syringe and expel air or other motivation into the vial 3650 to thereby apply pressure to the diaphragm 3653.

[0195] The diaphragm 3653 within the vial 3650 is flexible, so the diaphragm expands when a pressure is applied to the diaphragm 3653 by the pressure providing device 3660. FIG. 16B illustrates a case in which the plunger head 3662 of the pressure providing device 3660 has been advanced so as to increase a pressure of a side of the diaphragm 3653 in the vial 3653 and, thus, cause the diaphragm 3653 to expand within the vial 3650. As the diaphragm 3653 expands due to the pressure from the pressure providing device 3660, an interior volume of the vial 3650 in which the fluidic medium is contained is reduced in size and, as a consequence, the fluidic medium is forced out of the vial 3650 through the fluid path to the interior volume of the reservoir 3610. The inflow of fluidic medium to the interior volume of the reservoir 3610 causes the plunger head 3620 to move backwards within the reservoir 3610. Increasing pressure may be applied from the pressure providing device 3660 to the diaphragm 3653 of the vial 3650 until a desired amount of fluidic medium has been filled into the reservoir 3610.

[0196] Thus, embodiments of the present invention provide a flexible diaphragm in a bottom of a vial and allow for external pressure to be applied to the flexible diaphragm so as to force a fluidic medium, such as insulin, or the like, into a reservoir. In various embodiments, a membrane is incorporated into the fluid flow path to trap air bubbles. In some embodiments of the method using the system 3600, an initial vacuum is applied to the vial 3650 to evacuate air in a dead space of the reservoir 3610 into the vial 3650 prior to filling the reservoir 3610.

[0197] FIG. 17A illustrates a cross-sectional view of a system 3700 in accordance with an embodiment of the present invention. The system 3700 includes a reservoir 3710, a plunger head 3720, a plunger arm 3750, a transfer guard 3740, a vial 3750, and a moveable element 3770. The reservoir 3710 has a hollow interior for containing a fluidic medium. The plunger head 3720 is located within the reservoir 3710 and is moveable in an axial direction of the reservoir 3710, to expand or contract an interior volume of the reservoir 3710. The plunger arm 3730 is connected to the plunger head 3720. In various embodiments, the reservoir 3710 includes a septum 3718 that is able to be pierced by a needle, such that the hollow interior of the reservoir 3710 is able to be filled with a fluidic medium that passes through the needle once the needle has pierced the septum 3718.

[0198] The moveable element 3770 is located within the vial 3750 and is moveable within the vial 3750 to expand or contract an interior volume of the vial 3750. The inner surface 3751 of the vial 3750 and a surface of the moveable element 3770 define an interior volume of the vial 3750 that is able to contain a fluidic medium. In various embodiments, the moveable element 3770 comprises rubber, plastic, or the like. Also, in various embodiments, the moveable element 3770 comprises a plunger, or the like. In some embodiments, the vial 3750 further includes a septum 3754 that is able to be pierced by a needle, such that a fluidic medium is able to be expelled from the vial 3750 through the needle once the needle has pierced the septum 3754.

[0199] The moveable element 3770 is able to move within the vial 3750 when a pressure is applied to the moveable element 3770. In various embodiments, the moveable element includes a barrel portion 3771 and a curved portion 3772, where a contour of an outer surface of the barrel portion 3771 is substantially the same as a contour of an inner surface 3751 of a barrel portion 3755 of the vial 3750, and where a contour of an outer surface of the curved portion 3772 is substantially the same as a contour of a curved portion 3756 of the vial 3750. Also, in various embodiments, the moveable element 3770 includes one or more 0-rings 3773 that surround the barrel portion 3771 of the moveable element 3770 and that are in contact with the inner surface 3751 of the barrel portion 3755 of the vial 3750 when the moveable element 3770 is within the vial 3750.

[0200] The transfer guard 3740 includes one or more needles 3742 for providing a fluid path from an interior volume of the vial 3750 to an interior volume of the reservoir 3710. In various embodiments, the transfer guard 3740 includes walls that help to shield the one or more needles 3742 from contact with a hand of a user when the user is connecting the vial 3750 and the reservoir 3710 with the transfer guard 3740. The one or more needles 3742 of the transfer guard 3740 are able to pierce the septum 3754 of the vial 3750 and the septum 3718 of the reservoir 3710, so as to provide a fluid path from the vial 3750 to the reservoir 3710. In various embodiments, the transfer guard 3740 may include a membrane 3741 that is incorporated into the fluid flow path of the transfer guard 3740 to trap air bubbles as a fluidic medium passes along the fluid flow path from the vial 3750 to the reservoir 3710.

[0201] A method in accordance with an embodiment of the present invention allows for filling the reservoir 3710 in the system 3700. A first step in the method is to connect the vial 3750 to the reservoir 3710 using the transfer guard 3740. An example of such a connected structure is illustrated in FIG. 17A. A second step in the method is to apply pressure to a side of the moveable element 3770 in the vial 3750 that is opposite a side of moveable element 3770 that is in contact with a fluidic medium. For example, a user or a device may press on an external surface of the moveable element 3770 to advance the moveable element within the vial 3750. Thus, the moveable element 3770 acts as a moveable bottom of the storage vial 3750. In various embodiments, the moveable element 3770 may further include a handle (not shown) connected to the moveable element 3770 for applying pressure to the moveable element 3770.

[0202] When a pressure is applied to the moveable element 3770 to advance the moveable element 3770 within the vial 3750, the fluidic medium within the vial 3750 is forced through the needle 3742 and into the reservoir 3710. FIG. 17B illustrates a cross-sectional view of the system 3700 once the moveable element 3770 has been at least partially advanced within the vial 3750. When a force is applied to the moveable element 3770 to force fluidic medium from the vial 3750 to fill the reservoir 3710, the plunger head 3720 is forced backward within the reservoir 3710 by the force of the fluidic medium entering the reservoir 3710. Thus, embodiments of the present invention allow for a storage vial with a moveable bottom, and for applying a pressure to the moveable bottom of the storage vial to fill a reservoir. Also, when the fluidic medium passes from the vial 3750 to the reservoir 3710, the fluidic medium is passed through the membrane 3741 of the transfer guard 3740, which substantially removes air bubbles from the fluidic medium prior to the fluidic medium filling into the reservoir 3710.

[0203] FIG. 18A illustrates a cross-sectional view of a system 3800 in accordance with an embodiment of the present invention. The system 3800 includes a degassing tool 3801 and a vial 3830. The degassing tool 3801 includes a first handle 3802, a second handle 3804, a pivot member 3810, a first arm 3808, a second arm 3806, a holding arm 3812, a plunger housing 3824, a plunger head 3820, a plunger arm 3822, and an insertion member 3850.
The vial 3830 contains a fluidic medium, such as insulin, or the like, up to a certain level within the vial 3830, and an area of the vial 3830 above the fluidic medium forms a headspace 3844 of the vial 3830. The vial includes a septum 3832 that may be pierced by the insertion member 3850 of the degassing tool 3801.

[0204] The first handle 3802, the second handle 3804, the first arm 3808, and the second arm 3806 are connected together by the pivot member 3810. In various embodiments, the first handle 3802, the pivot member 3810, and the first arm 3808 are formed as a single unit, and the second handle 3804 and the second arm 3806 are formed as a single unit. The first handle 3802 is able to pivot toward and away from the second handle 3804. The second arm 3806 may have a cavity for surrounding a neck of a vial. The holding arm 3812 extends from the second arm 3806 and holds the plunger housing 3824 between the first arm 3808 and the second arm 3806. The plunger head 3820 is connected to the plunger arm 3822 and the plunger head 3820 is able to slide within the plunger housing 3824. The insertion member 3850 may be, for example, a needle, and is connected to an output port of the plunger housing 3824. The plunger arm 3822 is connected to the first arm 3808.

[0205] The degassing tool 3801 is configured such that when the first handle 3802 is pivoted away from the second handle 3804, the first arm 3808 is pivoted such that the plunger arm 3822 causes the plunger head 3820 to advance within the plunger housing 3824 to reduce a volume in the plunger housing 3822 between the plunger head 3820 and the output port to the insertion member 3850. The degassing tool 3801 is also configured such that when the first handle 3802 is pivoted toward the second handle 3804, the first arm 3808 is pivoted such that the plunger arm 3822 causes the plunger head 3820 to retract within the plunger housing 3824 to increase a volume in the plunger housing 3822 between the plunger head 3824 and the output port to the insertion member 3850.

[0206] A method in accordance with the present invention allows for degassing the vial 3830 using the degassing tool 3801. In a first step, the first handle 3802 of the degassing tool 3801 is pivoted away from the second handle 3804, which causes the first arm 3808 to push on the plunger arm 3822 and, thus, advance the plunger head 3820 within the plunger housing 3824. In a second step, the insertion member 3850 is inserted through the septum 3832 of the vial 3830 and into the headspace 3844 of the vial 3830 above the fluidic medium 3842 within the vial 3830. An example of such a connection of the degassing tool 3801 and the vial 3830 is illustrated in FIG. 18A.

[0207] In a third step, the first handle 3802 of the degassing tool 3801 is pivoted toward the second handle 3804, which causes the first arm 3808 to pull on the plunger arm 3822 and, thus, retract the plunger head 3820 within the plunger housing 3824. FIG.

illustrates a cross-section of the system 3800 in accordance with an embodiment of the present invention when the first handle 3802 has been pivoted toward the second handle 3804. When the plunger head 3820 retracts within the plunger housing 3824, air or gas in the headspace 3844 of the vial 3830 is drawn through the insertion member 3850 and into the plunger housing 3824. In various embodiments, the degassing tool 3801 is operated by a hand of a user. Once the gas has been drawn out of the headspace 3844 of the vial 3830, the vial 3830 is disconnected from the degassing tool 3801 and may be used to fill a reservoir.
Thus, embodiments of the present invention provide for a hand powered purging device or degassing tool that can be connected to existing drug vials and, by performing a pumping action, can reduce a pressure inside of a vial by causing out-gassing to occur before using the vial to fill a reservoir.

[0208] FIG. 19 illustrates cross-sectional view of a system 3900 in accordance with an embodiment of the present invention. The system 3900 includes a reservoir 3920 and a vial 3910. The reservoir 3920 includes a front surface 3924, a bellows portion 3922 connected to the front surface, and a septum 3926. The bellows portion 3922 comprises an accordion like structure, and is able to expand and contract to change an interior volume within the bellows portion 3922. Such a bellows portion 3922 allows for substantially eliminating a reservoir headspace when the bellows portion 3922 is fully contracted. In various embodiments, the system 3900 further includes a needle 3930 for providing a fluid path between the vial 3910 and the reservoir 3920. In some embodiments, a vacuum is applied to the reservoir 3920 such that the bellows portion 3922 is fully contracted prior to being filled, and then once the needle 3930 pierces the septum 3926 of the reservoir 3920, the bellows portion 3922 expands to fill with a fluidic medium transferred from the vial 3910 through the needle 3930.

[0209] FIG. 20A illustrates a cross-sectional view of a system 4000 in accordance with an embodiment of the present invention. The system 4000 includes a vial 4010, a reservoir 4020, a plunger head 4024, a plunger arm 4026, a transfer guard 4040, and an automated filling device 4030. The vial 4010 includes a septum 4012, and the vial 4010 allows for containing a fluidic medium. The reservoir 4020 has a hollow interior for containing a fluidic medium. The plunger head 4024 is located within the reservoir 4020 and is moveable within the reservoir 4020 to expand or contract an interior volume of the reservoir 4020. The plunger head 4024 is connected to the plunger arm 4026. The reservoir 4020 includes a septum 4022 at a port of the reservoir 4020. The transfer guard 4040 includes one or more needles 4042 for providing a fluid path from an interior volume of the vial 4010 to an interior volume of the reservoir 4020. The one or more needles 4042 of the transfer guard 4040 are able to pierce the septum 4012 of the vial 4010 and the septum 4022 of the reservoir 4020, so as to provide a fluid path from the vial 4010 to the reservoir 4020.

[0210] The automated filling device 4030 allows for automating a filling process of filling the reservoir 4020 with a fluidic medium from the vial 4010. The automated filling device 4030 includes a first spring 4032, a second spring 4034, a handle 4036. In various embodiments, the automated filling device 4030 further includes a latch 4038.
In various embodiments, the plunger arm 4026 and the handle 4036 are configured such that the plunger arm 4026 is able to snap together with the handle 4036 to connect the plunger arm 4026 to the handle 4036. In various other embodiments, the plunger arm 4026 and the handle 4036 are configured to be connected in other ways, such as by screwing the plunger arm 4026 into the handle 4036. In some embodiments, the handle 4036 is part of the plunger arm 4026, and the handle 4036 is able to be connected to the first spring 4032 and the second spring 4034.

[0211] The first spring 4032 and the second spring 4034 are connected between a top surface of the automated filling device 4030 and the handle 4036. Both the first spring 4032 and the second spring 4034 are initially biased toward an expanded position, but are held compressed by the handle 4036, which may be held up by the latch 4038. The automated filling device 4030 allows for the reservoir 4020 to be snapped or otherwise connected in place within the automated filling device 4030, and then allows for filling the reservoir 4020 using a force applied by the first spring 4032 and the second spring 4034 on the handle 4036 when the latch 4038 is opened to allow the first spring 4032 and the second spring 4034 to push down on the handle 4036. In the system 4000, the handle 4036 is connected to the plunger arm 4026, and the plunger arm 4026 is connected to the plunger head 4024, such that a movement of the handle 4036 away from the reservoir 4020 causes the plunger head 4024 to retract within the reservoir 4020 to create a vacuum that enables a filling of the reservoir 4020.

[0212] A method in accordance with an embodiment of the present invention allows for using the automated filling device 4030 to fill the reservoir 4020 with a fluidic medium from the vial 4010. In a first step of the method, the first spring 4032 and the second spring 4034 are compressed by a force applied to the handle 4036, and the latch 4038 is engaged with the handle 4036 to hold the handle 4036 in place with the first spring 4032 and the second spring 4034 compressed. In a second step of the method, the reservoir 4020 and the plunger arm 4026 are connected to the automated filling device, such as by snapping the plunger arm 4026 to the handle 4036. In a third step of the method, a fluid path is established between the vial 4010 and the reservoir 4020 by using the needle 4042 of the transfer guard 4040 to pierce the septum 4012 of the vial 4010 and to pierce the septum 4022 of the reservoir 4020.
In various embodiments, the vial 4010 is positioned in an inverted position when the fluid path is established with the reservoir 4020, such that a fluidic medium in the vial 4010 tends toward the septum 4012. An example of the system 4000 with such a connected structure is illustrated in FIG. 20A.

[0213] In a fourth step of the method, the latch 4038 is released, such that the first spring 4032 and the second spring 4034 are able to expand and move the handle 4036 away from the reservoir 4020. FIG. 20B illustrates a cross-sectional view of the system 4000 after the first spring 4032 and the second spring 4034 have expanded to move the handle 4036.
When the handle 4036 moves away from the reservoir 4020, the handle 4036 pulls the plunger arm 4026 to cause the plunger head 4024 to retract within the reservoir 4020. The retraction of the plunger head 4024 within the reservoir 4020 creates a vacuum that allows for the fluidic medium to be filled into the reservoir 4020 from the vial 4010. In various embodiments, the tension of the first spring 4032 and the second spring 4034 is selected so as to allow for the reservoir 4020 to fill slowly when the first spring 4032 and the second spring 4034 expand. Thus, various embodiments of the present invention allow for spring loaded automatic filling of a reservoir, and for slowly pulling a fluid or drug from an inverted vial into a reservoir. In some embodiments, a lead screw (not shown in FIG. 20B) may be used in place of the first spring 4032 and the second spring 4034 to move the plunger arm 4026 for an automated filling of the reservoir 4020.

[0214] FIG. 21A illustrates a cross-sectional side view of a system 4100 in accordance with an embodiment of the present invention. The system 4100 includes a vial 4110, a reservoir 4120, a plunger head 4122, a plunger arm 4124, and a stand 4130. The vial 4110 includes a septum 4112, and the vial allows for containing a fluidic medium.
The reservoir 4120 has a hollow interior for containing a fluidic medium. The plunger head 4122 is located within the reservoir 4120 and is moveable within the reservoir 4120 to expand or contract an interior volume of the reservoir 4120. The plunger head 4122 is connected to the plunger arm 4124. The reservoir 4120 includes a septum 4129 at a port of the reservoir 4120.

[0215] The stand 4130 includes a connection structure, such as a transfer guard, or the like, for providing a fluid path from the vial 4110 to the reservoir 4120. The stand 4130 includes a first needle 4134, a second needle 4132, an air filter 4136, a plunger head 4140, a pressure providing device 4142, and a plunger arm 4144 connected to the plunger head 4140. The first needle 4134 may be used to pierce the septum 4112 of the vial 4110, and the second needle 4132 may be used to pierce the septum 4129 of the reservoir 4120, and the first needle 4134 may be connected to the second needle 4132 through the air filter 4136.
The air filter allows for removing dissolved air from a fluidic medium being transferred from the vial 4110 to the reservoir 4120.

[0216] The plunger head 4140, the plunger arm 4144, and the pressure providing device 4142 allow for assisting with a filling of the reservoir 4120. In various embodiments, the pressure providing device 4142 comprises a spring, or the like, that is biased toward an expanded position. In various other embodiments, the pressure providing device includes a canister with compressed air, where the compressed air may be released to provide a pressure. An end 4146 of the plunger arm 4144 of the stand 4130 may be inserted into a receptacle 4126 of the plunger arm 4124, such that a movement of the plunger head 4140 causes a movement of the plunger arm 4144 that leads to a movement of the plunger arm 4124 that causes a movement of the plunger head 4122 within the reservoir 4120.

[0217] A method in accordance with an embodiment of the present invention allows for using the stand 4130 to assist in filling the reservoir 4120 from the vial 4110. In a first step of the method, the vial 4110 and the reservoir 4120 are connected to the stand 4130. For example, the stand 4130 may include a nest for the vial 4110 and a nest for the reservoir 4120. When the reservoir 4120 is attached to the stand 4130, the end 4146 of the plunger arm 4144 of the stand 4130 is inserted into the receptacle 4126 of the plunger arm 4124. In a second step of the method, the pressure providing device 4142 is caused to provide a pressure to the plunger head 4140 so as to move the plunger head 4140 to cause the plunger arm 4144 to move, which causes the plunger arm 4124 to move and, thus, causes the plunger head 4122 to retract within the reservoir 4120. FIG. 21B illustrates a cross-sectional side view of the system 4100 when the pressure providing device 4142 has caused a movement of the plunger head 4140 which has caused a movement of the plunger head 4122 within the reservoir 4120. When the plunger head 4122 is refracted within the reservoir 4122, a fluidic medium passes from the vial 4110 through the air filter 4136 and fills into the reservoir 4120. The air filter 4136 removes dissolved air from the fluidic medium.

[0218] FIG. 21C illustrates a cross-sectional side view of the system 4100 in accordance with another embodiment of the present invention. In the embodiment of FIG.
21C, the plunger arm 4144 includes a handle 4192 at an end of the plunger arm 4144.
Also, in the embodiment of FIG. 21C, the system 4100 includes a pressure channel 4190 and an air path 4194. In the embodiment of FIG. 21C, the handle 4192 may be pressed to move the plunger head 4140 and create a pressure within the pressure channel 4190, which then pushes air through the air path 4194 to increase a pressure within the vial 4110 and, as a consequence, forces a fluidic medium from the vial 4110 to the reservoir 4120.

[0219] FIG. 21D illustrates a cross-sectional top view of the system 4100 in accordance with an embodiment of the present invention. The system 4100 includes a first holding member 4162 for holding the vial 4110, and a second holding member 4164 for holding the reservoir 4120. A transfer guard 4131 that is part of the stand 4130 (refer to FIG. 21A) includes a first nest 4139 for holding the vial 4110 and a second nest 4138 for holding the reservoir 4120. FIG. 21E illustrates a cross-sectional side view of the system 4100 in accordance with an embodiment of the present invention in which the first holding member 4162 and the second holding member 4164 may be folded together around the transfer guard 4131. FIG. 21F illustrates a cross-sectional side view of the system 4100 of FIG. 21E in which the first holding member 4162 and the second holding member 4164 have been unfolded.

[0220] FIG. 22A illustrates a cross-sectional view of a system 4200 in accordance with an embodiment of the present invention. The system 4200 includes a reservoir 4210, a plunger head 4220, a plunger arm 4230, a transfer guard 4240, a vial 4250, and a vacuum plunger 4260. The vial 4250 has a hollow interior for containing a fluidic medium. The reservoir 4210 has a hollow interior for containing a fluidic medium. The plunger head 4220 is located within the reservoir 4210 and is moveable within the reservoir 4210 to expand or contract an interior volume of the reservoir 4210. The plunger head 4220 is connected to the plunger arm 4230. The vacuum plunger 4260 includes a plunger head 4262, a plunger arm 4263 connected to the plunger head 4262, and a handle 4264 connected to the plunger arm 4263. The plunger head 4262 is moveable within a housing of the vacuum plunger to expand or contract an interior volume of the vacuum plunger 4260.

[0221] The transfer guard 4240 includes a reservoir nest 4241, a vial nest 4242, a vacuum plunger nest 4243, a first valve 4244, a second valve 4245, a third valve 4246, a filter 4247, a first needle 4248, and a second needle 4249. The reservoir nest 4241 is configured to be connected to the reservoir 4210, such that the first needle 4248 is inserted into the interior volume of the reservoir 4210. The vial nest 4242 is configured to be connected to the vial 4250, such that the second needle 4250 is inserted into an interior volume of the vial 4250.

The vacuum plunger nest 4243 is configured to be connected to the vacuum plunger 4260.
The first valve 4244 allows for a fluidic medium to flow into the reservoir 4210 when the first valve 4244 is open, and prevents a fluidic medium from flowing into the reservoir 4210 when the first valve 4244 is closed. The second valve 4245 allows for a fluidic medium to flow out of the vial 4250 when the second valve 4245 is open, and prevents a fluidic medium from flowing out of the vial 4250 when the second valve 4245 is closed.
The third valve 4246 allows for a fluidic medium to flow into and out of the vacuum plunger 4260 when the third valve 4246 is open, and prevents a fluidic medium from flowing into or out of the vacuum plunger 4260 when the third valve is closed. The filter 4247 allows for filtering air from a fluidic medium.

[0222] A method in accordance with the present invention allows for filling the reservoir 4210 using the transfer guard 4240. In a first step of the method, the reservoir nest 4241 is connected to the reservoir 4210, the vial nest 4242 is connected to the vial 4250, and the vacuum plunger nest 4243 is connected to the vacuum plunger 4260. Also, in an initial position, the plunger head 4262 is depressed within the vacuum plunger 4260, and the plunger head 4220 is depressed within the reservoir 4210. Moreover, in an initial state, the first valve 4244, the second valve 4245, and the third valve 4246 are all closed. An example of the system 4200 in such a state is illustrated in FIG. 22A.

[0223] In a second step of the method, the second valve 4245 and the third valve 4246 are opened, and the handle 4264 is pulled to cause the plunger head 4262 to retract within a housing of the vacuum plunger 4260. FIG. 22B illustrates a cross-sectional view of the system 4200 in accordance with an embodiment of the present invention when the plunger head 4262 has been retracted within a housing of the vacuum plunger 4260. By refracting the plunger head 4262 within the housing of the vacuum plunger 4260 when the second valve 4245 and the third valve 4246 are open, a fluidic medium is caused to flow from the vial 4250 into an interior volume of the vacuum plunger 4260.

[0224] In a third step of the method, the second valve 4245 is closed and the first valve 4244 is opened, and the handle 4264 is pushed to cause the plunger head 4262 to advance within the housing of the vacuum plunger 4260. FIG. 22C illustrates a cross-sectional view of the system 4200 in accordance with an embodiment of the present invention when the plunger head 4262 has been advanced within the housing of the vacuum plunger 4260. By advancing the plunger head 4262 within the housing of the vacuum plunger 4260 when the third valve 4246 and the first valve 4244 are open, a fluidic medium is caused to flow from the vacuum plunger 4260 into the interior volume of the reservoir 4210 while forcing the plunger head 4220 to retract within the reservoir 4210. The filter 4247 filters air bubbles out of the fluidic medium as the fluidic medium passes from the vacuum plunger 4260 to the reservoir 4210.

[0225] Therefore, embodiments of the present invention allow for incorporating a series of valves into a transfer guard and for using a hand operated vacuum plunger and a filter or membrane to filter out air bubbles. Moreover, embodiments of the present invention allow for a two step degassing process in which a first step involves vacuum aspiration and a second step involves pushing a fluidic medium across a filter. Thus, embodiments of the present invention allow for filling a reservoir by pushing a fluidic medium across a filter and into the reservoir. In some embodiments, cavitation is used to degas a fluidic medium.

[0226] FIG. 23A illustrates a cross-sectional view of a system 4300 in accordance with an embodiment of the present invention. The system 4300 includes a reservoir 4310, a plunger head 4320, a plunger arm 4330, a vial 4350, a first needle 4341, a second needle 4342, a filter 4343, a driving shaft 4372, and a motor 4374. The vial 4350 has a hollow interior for containing a fluidic medium, and the vial 4350 includes a septum 4354. The reservoir 4310 has a hollow interior for containing a fluidic medium, and the reservoir 4310 includes a septum 4318. The plunger head 4320 is located within the reservoir 4310 and is moveable within the reservoir 4310 to expand or contract an interior volume of the reservoir 4310.
The plunger head 4320 is connected to the plunger arm 4330. The plunger arm 4330 may comprise, for example, a half-nut, a quarter nut, a U-shaped nut, or the like, that is able to engage with the drive shaft 4372. The drive shaft 4372 may be, for example, a partial screw or the like. The drive shaft 4372 is connected to the motor 4374, and the motor 4374 is able to be controlled to turn the drive shaft 4372 in a clockwise manner and in a counter-clockwise manner.

[0227] When the reservoir 4310 is connected to a fluid path for providing a fluidic medium to a body of a user, the motor 4374 may be controlled to turn the drive shaft 4372 in a certain direction to move the plunger arm 4330 and advance the plunger head 4320 within the reservoir 4310. During a filling process, the motor 4374 may be controlled to turn the drive shaft 4372 in a reverse direction from the certain direction so as to move the plunger arm 4330 and retract the plunger head 4320 within the reservoir 4310. The first needle 4341 is able to pierce the septum 4354 of the vial 4350 and the second needle 4342 is able to pierce the septum 4318 of the reservoir 4310, such that a fluid path may be established from the vial 4350 to the reservoir 4310 through the filter 4343. The filter 4343 allows for substantially removing air bubbles from a fluidic medium that passes from the vial 4350 to the reservoir 4310.

[0228] Thus, by turning the drive shaft 4372 in a specified direction, the plunger head 4320 is able to be retracted within the reservoir 4310 and, thus, a fluidic medium may be drawn from the vial 4350 into the reservoir 4310 by turning the drive shaft 4372 in the specified direction. In various embodiments, the same motor 4374 and drive shaft 4372 are used for both filling the reservoir 4310 and expelling a fluidic medium from the reservoir 4310 to a user. FIG. 23B illustrates a cross-sectional view of the system 4300 in accordance with an embodiment of the present invention in which the drive shaft 4372 has been turned by the motor 4374 to cause the plunger head 4320 to retract within the reservoir 4310. In various embodiments, the plunger arm 4330 is configured to provide a positive engagement with the drive shaft 4372 regardless of a direction of turning of the drive shaft 4372. Also, in various embodiments, more energy is provided to the motor 4374 when turning the drive shaft 4372 to retract the plunger head 4320 than when turning the drive shaft 4372 to advance the plunger head 4320, so as to allow for a faster refraction motion to fill the reservoir 4310.

[0229] FIG. 24 illustrates a cross-sectional view of a system 4400 in accordance with an embodiment of the present invention. The system 4400 includes a reservoir 4410, a plunger head 4420, a plunger arm 4430, a septum 4440, a membrane 4452, a channel 4454, a spring 4472, a seal 4474, and a valve 4476. The reservoir 4410 has a interior volume 4482 for containing a fluidic medium between the plunger head 4420 and the septum 4440.
The reservoir 4410 also has a chamber 4484 on an opposite side of the plunger head 4420 from the interior volume 4482. The plunger head 4420 may be advanced within the reservoir 4410 to expel a fluidic medium from the reservoir 4410. The spring 4472 is connected between a surface of the reservoir 4410 and the plunger head 4420 in the chamber 4484.
The seal 4474 creates a substantially air-tight seal around the plunger arm 4430 in a location where the plunger arm 4430 exits the chamber 4484. The valve 4476 allows for a vacuum to be applied to the chamber 4484. The membrane 4452 is located in an opening in a wall of the reservoir 4410 and air is able to pass from the interior volume 4482 through the membrane 4452 and through the channel 4454 into the chamber 4484. The membrane may comprise, for example, a hydrophobic material, or the like.

[0230] In some embodiments, a vacuum is applied to the chamber 4484 through the valve 4476 to create a vacuum in the chamber 4484, and then the valve 4476 is closed. The membrane 4452 and the channel 4454 allow for a transfer of air bubbles from a fluidic medium side of the plunger head 4420 to a back side of the plunger head 4420.
The membrane 4452 substantially prevents a loss of fluid through the channel 4454.
A slight vacuum in the chamber 4484 and a backing of the plunger head 4420 by the spring 4472 promote the migration of air bubbles from the interior volume 4482 to the chamber 4484 through the channel 4454 without greatly affecting operational forces. Thus, embodiments of the present invention allow for a vacuum pull in a chamber behind a plunger head to pull air out of an interior volume of a reservoir through a channel from the interior volume to the chamber. Such embodiments may allow for continuous degassing of a fluid in the interior volume of the reservoir.

[0231] FIG. 25 illustrates a cross-sectional view of a system 4500 in accordance with an embodiment of the present invention. The system 4500 includes a reservoir 4510, a plunger head 4520, a plunger arm 4530, a septum 4540, a bellows member 4572, a one-way valve 4574, and one or more membranes 4590. The plunger head 4520 is connected to the plunger arm 4530, and the plunger head 4520 may slide within the reservoir 4510. The reservoir 4510 has an interior volume 4582 for containing a fluidic medium between the plunger head 4520 and the septum 4540, where the septum 4540 is located at an exit port of the reservoir 4510. The bellows member 4572 is connected between a back surface 4512 of the reservoir 4510 and the plunger head 4520. The bellows member 4572 is connected to a backside of plunger head 4520 that is opposite a side of the plunger head 4520 that contacts a fluidic medium. The bellows member 4572 is sealed to the plunger head 4520. The one or more membranes 4590 are located on a face of the plunger head 4520 that comes in contact with a fluidic medium, and the one or more membranes 4590 lead to channels through the plunger head 4520 that extend from the face of the plunger head 4520 to the backside of the plunger head 4520.

[0232] The one or more membranes 4590 comprise, for example, a hydrophobic material, or the like, that allows for air to pass through, but substantially prevents a passage of a fluid.
Thus, air is able to pass from the interior volume 4582 of the reservoir 4510 through the one or more membranes 4590 and through the plunger head 4520 into an area 4584 within the bellows member 4572. The bellows member 4572 is able to expand or contract with a movement of the plunger head 4520. As the plunger head 4520 is moved forward to deliver a fluidic medium, a vacuum is generated in the bellows member 4572 and, thus, air bubbles or vapor are drawn through the one or more membranes 4590 and into the area 4584 within the bellows member 4572. When the reservoir 4510 is completely filled, the bellows member 4572 is fully compressed, and the air in the bellows member 4572 is forced through the one-way valve 4574.

[0233] FIG. 26 illustrates a cross-sectional view of a system 4600 in accordance with an embodiment of the present invention. The system 4600 includes a vial 4610, an air sack 4630, a one-way valve 4632, an air line 4634, a drive shaft 4636, a fluid line 4622, a filter 4624, and an insertion line 4626. The vial 4610 contains a fluidic medium 4614 within a housing of the vial 4610. An air space is provided in the vial 4610 in an area 4616 above the fluidic medium 4614. The fluid line 4622 may be inserted into the vial 4610 through a septum 4612 of the vial 4610. One end of the air line 4634 is connected to the one-way valve, and another end of the air line 4634 is inserted into the area 4616 of the vial 4634 above the fluidic medium 4614. The one-way valve allows for air to be pushed out of the air sack 4630 and through the air line 4634 into the area 4616 in the vial 4610.

[0234] The drive shaft 4636 allows for compressing the air sack 4630 so as to cause air to be pushed through the one-way valve 4632 and through the air line 4634. One end of the fluid line 4622 is positioned within the fluidic medium 4614 in the vial 4610, and another end of the fluid line 4622 is connected to the filter 4624. The filter 4624 allows for filtering air bubbles out of a fluidic medium that passes from the fluid line 4622 to the insertion line 4626 through the filter 4624. During operation, the drive shaft 4636 compresses the bulb or air sack 4630 to force air into the vial 4610 through the air line 4634. The air that exits the air line 4634 in the vial 4610 is provided into the area 4616 that is above the fluidic medium 4614, so the air from the air line 4634 is provided into the vial 4610 without percolating through the fluidic medium 4614. An increase in pressure caused by air from the air line 4634 forces the fluidic medium 4614 through the fluid line 4622 to the filter 4624 and on to the insertion line 4626. In various embodiments, the insertion line 4626 is inserted into a reservoir (not shown in FIG. 26), such that the reservoir is able to be filled from the vial 4610. Also, in various alternate embodiments, the fluidic medium 4614 may be delivered directly through the fluid line 4622 without passing through the filter 4624.

[0235] FIG. 27 illustrates a system 4700 in accordance with an embodiment of the present invention. The system 4700 includes a pressure sack 4720, a one-way valve 4770, a reservoir sack 4710, and an outlet path 4717. The system 4700 is configured such that when the reservoir sack 4710 contains a fluidic medium, the pressure sack 4720 may be used to force air through the one-way valve 4770 and, thus, cause the fluidic medium to be expelled from the reservoir sack 4710 through the outlet path 4717.

[0236] FIG. 28 illustrates a cross-sectional view of a system 4800 in accordance with an embodiment of the present invention. The system 4800 includes a reservoir 4810, a plunger head 4820, a plunger arm 4830, a handle 4832, a spring 4834, a septum 4814, a first needle 4871, a second needle 4872, a long needle 4873, a hydrophobic membrane 4874, an air inlet 4875, a vial 4850, a septum 4852, a transfer guard 4870, and a filter 4877.
The system 4800 is configured such that when the vial 4850 is inverted and the long needle 4873 is inserted into the vial 4850, the long needle 4873 vents to atmosphere from the air inlet 4875 to a headspace 4856 in the vial 4850 above an area 4854 of the vial 4850 that contains the fluidic medium. Thus, by using the long needle 4873 to vent the headspace 4856 of the vial 4850 to atmosphere, there is no percolation of air through the fluidic medium in the vial 4850.

[0237] The hydrophobic membrane 4874 substantially reduces an addition of water vapor through the long needle 4873 to the vial 4850. The system 4800 is configured such that as a fluidic medium is drawn into the reservoir 4810, it passes through the filter 4877, which may comprise a membrane, to filter out air bubbles and/or degas the fluidic medium. The venting with the long needle 4873 eases filling and may eliminate a need for a current first step in a filling processes that requires forcing air into the vial 4850.
Thus, the long needle 4873 in the vial 4850 provides for atmospheric pressure in the headspace 4856 of the vial 4850. Also, water vapor is restricted from entering the vial 4850 through the long needle 4873 by the hydrophobic membrane 4874. Equalizing a pressure of the vial 4850 with an atmospheric pressure helps to prime the vial 4850. The spring 4834 provides a retaining force behind the plunger head 4820 in the reservoir 4810. Thus, the system 4800 provides for a vial pressure equalizer using the long needle 4873, with a spring 4834 to assist movement of the plunger head 4820, and a filter 4877 to filter air bubbles out of a fluidic medium as the fluidic medium is filled into the reservoir 4810.

[0238] FIG. 29 illustrates a cross-sectional view of a system 4900 in accordance with an embodiment of the present invention. The system 4900 includes a reservoir 4910, a plunger head 4920, a plunger head septum 4922, a plunger rod 4930, a handle 4934, a pressurized vessel 4932, a reservoir septum 4914, a first short needle 4942, a second short needle 4944, an air filter 4947, a hydrophobic membrane 4948, a transfer guard 4940, a vial 4950, a vial septum 4952, and a long needle 4945. The vial 4950 has a headspace 4956 that is above a fluidic medium 4954 within the vial 4950.

[0239] The pressurized vessel 4932 contains air under pressure and is located within the plunger rod 4930 and the handle 4934. The long needle 4945 penetrates the plunger head septum 4922, the reservoir septum 4914, and the vial septum 4952 to provide an air path between the pressurized vessel 4932 and the headspace 4956 in the vial 4950.
The hydrophobic membrane 4948 restricts fluid and vapor from passing through the long needle 4945. The first short needle 4942, the filter 4947, and the second short needle 4944 provide a fluid path from the vial 4950 to the reservoir 4910. Thus, air passes through the long needle 4945 from the pressurized vessel 4932 to the headspace 4956 in the vial 4950, and the fluidic medium 4954 in the vial 4950 is forced out of the vial 4950 due to the pressure from the pressurized vessel 4932, and the fluidic medium 4954 flows from the vial 4950 through the second short needle 4944, the filter 4947, and the first short needle 4942 to the reservoir 4910. The filter 4947 allows for filtering air bubbles from the fluidic medium as the fluidic medium passes from the vial 4950 to the reservoir 4910. In various embodiments, the pressurized vessel 4932 is contained entirely within the plunger rod 4930.

[0240] FIG. 30 illustrates a cross-sectional view of a system 5000 in accordance with an embodiment of the present invention. The system 5000 includes a reservoir 5010, a plunger head 5020, a plunger head septum 5022, a reservoir septum 5014, a short needle 5064, a hydrophobic filter 5062, a plunger arm 5030, a vial 5050, a vial septum 5052, a bellows 5070, a needle 5072, and a long needle 5042. The reservoir 5010 has an interior volume 5017 for holding a fluidic medium between the plunger head 5020 and the septum 5014.
The plunger head 5020 is moveable within the reservoir 5010. One end of the short needle 5064 is inserted through the reservoir septum 5014, and another end of the short needle 5064 is connected to the hydrophobic membrane 5062.

[0241] The vial 5050 is able to remain upright during a filling processes when a fluidic medium is transferred from the vial 5050 to the reservoir 5010. One end of the needle 5072 is connected to the bellows 5070, and another end of the needle 5072 pierces the vial septum and is positioned in a headspace within the vial 5050. The long needle 5042 is positioned to run from a lower region of the vial 5050 through the vial septum 5052 and through the plunger arm 5030, and through the plunger head septum 5022 into the interior volume 5017 of the reservoir 5010. In various embodiments, the plunger head septum 5022 may be at an end of a channel through a center of the plunger head 5020. Thus, the long needle 5042 is able to pass from a backside of the plunger head 5020 and into the interior volume 5017 of the reservoir 5010. The short needle 5064 allows for venting air through the hydrophobic membrane 5062, and the hydrophobic membrane substantially prevents a loss of a fluidic medium through the short needle 5064 during a filling process.

[0242] During a filling process, the bellows 5070 is compressed to force air through the needle 5072 and into the vial 5050. An increase pressure in the vial 5050 due to the air from the bellows 5070 forces a fluidic medium from the vial 5050 up the long needle 5042 and into the interior volume 5017 of the reservoir 5010. In various embodiments, during the filling processes, the plunger head 5020 is held stationary, but the reservoir 5010 is allowed to move upward with respect to the plunger head 5020 so as to increase a volume of the interior volume 5017 and allow for a fluidic medium to flow into the interior volume 5017 from the vial 5050 when the bellows 5070 is compressed.

[0243] FIG. 31 illustrates a cross-sectional view of a system 5100 in accordance with an embodiment of the present invention. The system 5100 includes a reservoir 5110, a plunger head 5120, a plunger arm 5130, a handle 5132, a vial 5150, a pressure source 5160, a piston 5162, an air needle 5142, a first fluid needle 5144, a second fluid needle 5146, and a filter 5140. The piston 5162 is moveable within the pressure source 5160 to generate pressure.
The air needle 5142 provides a path for air to pass from the pressure source 5160 to an interior of the vial 5150. The vial 5150 contains a fluidic medium. The vial 5150 is connected to the filter 5140 by the first fluid needle 5144 and the second fluid needle 5146.

The filter is connected to a port of the reservoir 5110. The reservoir 5110 has an interior volume for holding a fluidic medium. The plunger head 5120 is able to slide within the reservoir 5110.

[0244] During a filling operation with the system 5100, the piston 5162 is advanced within the pressure source 5160 to force air through the air needle 5142 and into the vial 5150. The increased pressure in the vial 5150 due to the pressure from the pressure source causes a fluidic medium in the vial 5150 to be expelled through the first fluid needle 5144 and the second fluid needle 5146 to the filter 5140. The filter 5140 filters air bubbles out of the fluidic medium, and then the fluidic medium fills into the interior volume of the reservoir 5110. Thus, in various embodiments, a fluidic medium or solution, such as insulin, is forced across a filter during filling, and the fluidic medium is pushed into a reservoir rather than being pulled into the reservoir. Also, while the system 5100 is illustrated as a multiple needle design with a first fluid needle 5144 and a second fluid needle 5146, it should be appreciated that, in various embodiments, more than two fluid needles may be used between the vial 5150 and the filter 5140 and that, in various other embodiments, a single fluid needle may be used between the vial 5150 and the filter 5140.

[0245] FIG. 32 illustrates a cross-sectional view of a system 5200 in accordance with an embodiment of the present invention. The system 5200 includes a reservoir 5210, a plunger head 5220, a plunger arm 5230, a handle 5232, a vial 5250, and a transfer guard 5240. The transfer guard 5240 includes a first needle 5242, a second needle 5245, and a pressure valve 5244. The vial 5250 contains a fluidic medium 5254. The reservoir 5210 is able to contain a fluidic medium within an interior volume of the reservoir 5210. The plunger head 5220 is able to slide within the reservoir 5210.

[0246] The transfer guard 5240 is configured such that when the vial 5250 is attached to the transfer guard 5240, the first needle 5242 and the second needle 5245 pierce a septum 5252 of the vial 5250. The transfer guard 5240 is further configured such that when the reservoir 5210 is attached to the transfer guard 5240, the first needle 5242 pierces a septum 5214 of the reservoir 5210. Thus, the transfer guard 5240 allows for establishing a fluid transfer path from the vial 5250 to the reservoir 5210 through the first needle 5242.

[0247] One end of the second needle 5245 is located within a headspace 5256 of the vial 5250 above the fluidic medium 5254 when the transfer guard 5240 is connected to the vial 5250. Another end of the second needle 5245 is connected to the one-way valve 5244. The one-way valve 5244 allows for air to enter the headspace 5256 of the vial 5250 through the second needle 5245, but substantially prevents liquid from coming out of the vial 5250 through the second needle 5245. In various embodiments, the second needle 5245 allows for venting the headspace 5256 of the vial 5250 to atmosphere and, thus, the handle 5232 can be used to pull the plunger head 5220 back to draw a fluidic medium out of the vial 5250 and into the reservoir 5210 without first having to pump air into the vial 5250 from the reservoir 5210.

[0248] FIG. 33 illustrates an adhesive patch 5400 in accordance with an embodiment of the present invention. The adhesive patch 5400 includes an area 5420 having a certain adhesion capability, and area 5440, area 5450, and area 5470 of increased adhesion capability as compared to the certain adhesion capability of the area 5420.

[0249] Disposable medical devices may be attached to a patient's skin. Due to variations in disposable medical devices, skin types, and skin sensitivity levels, sometimes large quantities of adhesive tapes and patches are used to affix a device to the skin, which may lead to excess perspiration, skin irritation, itching, discomfort, and possibly infection. This is especially true of patients with auto-immune deficiencies due to disease states or the administration of certain drug therapies. A medical adhesive with a high adhesion rate proximal to an infusion site, an insertion site, a wound site, or the like, and more breath-ability in areas more distant from such a site, would require a smaller contact area and, thus, may reduce skin irritation, perspiration, and a chance of infection. Such a medical adhesive may also promote device efficacy.

[0250] In FIG. 33, area 5430 indicates an infusion site, an insertion site, or the like. The adhesive patch 5400 features the area 5440 of increased adhesion capability around the area 5430. The areas 5440, 5450, and 5470 of the adhesive patch 5400 are merely illustrative of an example of a configuration of increased adhesion capability on an adhesive patch. It should be understood that embodiments of the adhesive patch 5400 are not limited to such an arrangement of areas of increased adhesion capability, but that areas of increased adhesion capability may be positioned in any arrangement on an adhesion patch.

[0251] Embodiments of the present invention allow for an adhesive patch, or adhesive tape, featuring areas with increased adhesion capability that ensure that a catheter, a sensor, or other device introduced through a patient's skin will remain in place. Such adhesive patches may allow for reducing an amount of skin coverage of the adhesive patch as compared with an adhesive patch that has only a uniform adhesion capability across the adhesive patch. Thereby, skin irritation and perspiration may be reduced with an adhesive patch having varying levels of adhesion capability in different areas on the adhesive patch, and comfort and wear-ability of a medical device that uses such an adhesive patch may be increased.

[0252] An adhesive patch having selective areas of increased adhesion capability may reduce a failure rate of infusion sets by providing increased adhesion capability around an insertion site of a catheter and, thus, helping to prevent the catheter from being partially pulled out an then kinked. Also, such adhesive patches with variable adhesion strength may allow for greater securing of a patch delivery system and minimize the patch footprint on the skin of the patient. Adhesive patches with variable adhesion strength may also allow for greater securing of glucose sensor products to a patient without increasing a patch size.
Embodiments of the present invention allow for selective use of augmented adhesives on an adhesive patch.

[0253] The embodiments disclosed herein are to be considered in all respects as illustrative, and not restrictive of the invention. The present invention is in no way limited to the embodiments described above. Various modifications and changes may be made to the embodiments without departing from the spirit and scope of the invention.
The scope of the invention is indicated by the attached claims, rather than the embodiments. Various modifications and changes that come within the meaning and range of equivalency of the claims are intended to be within the scope of the invention.

Claims

1. A system for use in filling one or more reservoirs, the system comprising:
a vial having an interior volume for containing a liquid;
a diaphragm arranged in the vial, the diaphragm defining a pressurizable volume, the diaphragm separating the interior volume of the vial from the pressurizable volume, the diaphragm inflatable to expel liquid from the interior volume in a case where a pressure within the pressurizable volume is increased to inflate the diaphragm; and a reservoir having an interior volume;
said diaphragm being inflatable to force liquid out of the interior volume of the vial and into the interior volume of the reservoir in a case where the interior volume of the vial is holding the liquid and the interior volume of the vial is connected to the interior volume of the reservoir by a needle and the pressure within the pressurizable volume is increased;
wherein a flow path between the interior volume of the vial and the interior volume of the reservoir is configured to reduce air bubbles from passing in the liquid as the liquid is transferred from the interior volume of the vial to the interior volume of the reservoir.

2. The system of claim 1, said diaphragm deflatable to increase the interior volume of the vial in a case where the pressure within the pressurizable volume is decreased.

3. The system of claim 1, said diaphragm attached to an inner surface of the vial.

4. The system of claim 1, further comprising:
a pressure providing device for changing a pressure within the pressurizable volume.

5. The system of claim 4, said pressure providing device including a syringe;
said syringe connectable to the vial such that in a case where the syringe is filled with air and is connected to the vial and a plunger head within the syringe is advanced, a pressure within the pressurizable volume is increased so as to cause the diaphragm to inflate and reduce the interior volume of the vial.

6. The system of claim 1, further comprising:
a reservoir having an interior volume;
said diaphragm deflatable to evacuate air from the interior volume of the reservoir into the interior volume of the vial in a case where the interior volume of the reservoir and the interior volume of the vial are connected by a needle and a vacuum is applied to the pressurizable volume of the vial.

7. The system of claim 1, said vial further comprising:
a first port for allowing liquid to be expelled from the interior volume of the vial;
and a second port for allowing a gas to be injected into the pressurizable volume of the vial.

8. A method for filling a reservoir, comprising:
providing a fluid flow path between an interior volume of a vial and an interior volume of the reservoir;
applying a pressure to a pressurizable volume of the vial so as to inflate a dia-phragm to cause liquid to be expelled from the interior volume of the vial into the interior volume of the reservoir; and filtering air from liquid as the liquid is expelled from the interior volume of the vial to the interior volume of the reservoir.

9. The method of claim 8, said applying the pressure comprising:
injecting at least one of a gas and a liquid from a pressure providing device into the pressurizable volume of the vial.

10. The method of claim 9, said pressure providing device including a syringe;
said injecting comprising injecting the at least one of the gas and the liquid from the syringe into the pressurizable volume of the vial by advancing a plunger head within the syringe.

11. The method of claim 8, further comprising:
applying a vacuum to the pressurizable volume of the vial so as to deflate the diaphragm to cause air to be evacuated from the interior volume of the reservoir into the interior volume of the vial.

12. The method of claim 11, said applying the vacuum occurring before said applying the pressure.

13. The system of claim 1, further comprising:
a filter arranged in the flow path to filter air bubbles so as to reduce air bubbles from passing in the liquid as the liquid is transferred from the interior volume of the vial to the interior volume of the reservoir.

14. The system of claim 4, wherein the pressure providing device is in communication with the pressurizable volume; and wherein the pressure providing device is external the vial.