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  Infusion pumps and methods and delivery devices and methods with sameUSPTO Application #: 20080097291Title: Infusion pumps and methods and delivery devices and methods with same Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient-user and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient-user or with an infusion medium, including a pump device, are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of the infusion medium from the reservoir and a drive device and drive linkage. (end of abstract) Agent: Foley & Lardner - Los Angeles, CA, US Inventors: Ian B. Hanson, Paul F. Bente, R. Paul Mounce, Colin A. Chong USPTO Applicaton #: 20080097291 - Class: 604 9301 (USPTO) The Patent Description & Claims data below is from USPTO Patent Application 20080097291. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001]The present invention relates to U.S. Application 60/839,741, filed Aug. 23, 2006, titled "Infusion Pumps And Methods And Delivery Devices And Methods With Same," which is incorporated herein by reference in its entirety and from which a priority filing date is claimed. The present invention also relates to U.S. Patent Application No. 60/678,290, filed May 6, 2005 and U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled "Infusion Device And Method With Disposable Portion," each of which is incorporated herein by reference in its entirety and from which the priority filing date is claimed. The present invention also relates to co-pending U.S. patent application No. 60/839,821, filed Aug. 23, 2006, titled "Infusion Medium Delivery Device And Method For Driving Plunger In Reservoir" (attorney docket no. 047711.0381); co-pending U.S. patent application No. 60/839,822, filed Aug. 23, 2006, titled "Infusion Medium Delivery Device And Method For Driving Plunger In Reservoir" (attorney docket no. 047711.0382); co-pending U.S. patent application No. 60/839,832, filed Aug. 23, 2006, titled "Infusion Medium Delivery Device With Compressible Or Curved Reservoir Or Conduit (attorney docket no. 047711.0383); and co-pending U.S. patent application No. 60/839,840, filed 8/23/2.006, titled "Infusion Medium Delivery Device, System And Method With Needle Inserter And Needle Inserter Device And Method" (attorney docket no. 047711.0384), the contents of each of which is incorporated herein by reference, in its entirety. Embodiments of the present invention also relate to: (i) U.S. patent application Ser. No. ______, filed Oct. 27, 2006, entitled "Infusion Medium Delivery Device and Method with Drive Device for Driving Plunger in Reservoir" (attorney docket no. 047711.0387); (ii) U.S. patent application Ser. No. ______, filed Oct. 27, 2006, entitled "Infusion Medium Delivery Device and Method with Compressible or Curved Reservoir or Conduit" (attorney docket no. 047711.0390); (iii) U.S. Provisional patent application Ser. No. ______, filed Oct. 27, 2006, entitled "Infusion Medium Delivery System, Device and Method with Needle Inserter and Needle Inserter Device and Method" (attorney docket no. 047711.0401); and (iv) U.S. patent application Ser. No. ______, filed Aug. 23, 2006, entitled "Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery" (attorney docket no. 047711.0393), the contents of each of which are incorporated by reference herein, in their entirety. FIELD OF THE INVENTION [0002]Embodiments of the present invention relate to an infusion medium delivery device for delivering an infusion medium to a patient-user, wherein the delivery device includes a base portion and a durable portion connectable to the base portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The base portion supports a reservoir, while the durable portion supports a drive device that is operatively coupled to the reservoir, to selectively drive fluid out of the reservoir. BACKGROUND OF THE INVENTION [0003]Certain chronic diseases may be treated, according to modern medical techniques, by delivering a medication or other substance to a patient's body, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is a chronic disease that is commonly treated by delivering defined amounts of insulin to the patient at appropriate times. Some common modes of providing an insulin therapy to a patient include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable pumps to deliver controlled amounts of insulin to a patient. [0004]Pump type delivery devices have been configured in external devices (that connect to a patient-user) or implantable devices (to be implanted inside of a patient-user's body). External pump type delivery devices include devices designed for use in a generally stationary location (for example, in a hospital or clinic), and further devices configured for ambulatory or portable use (to be carried by a patient-user). Examples of some external pump type delivery devices are described in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled "Infusion Device And Method With Disposable Portion" and Published PCT Application WO 01/70307 (PCT/US01/09139) titled "Exchangeable Electronic Cards For Infusion Devices" (each of which is owned by the assignee of the present invention), Published PCT Application WO 04/030716 (PCT/US2003/028769) titled "Components And Methods For Patient Infusion Device," Published PCT Application WO 04/030717 (PCT/US2003/029019) titled "Dispenser Components And Methods For Infusion Device," U.S. Patent Application Publication No. 2005/0065760 titled "Method For Advising Patients Concerning Doses Of Insulin," and U.S. Pat. No. 6,589,229 titled "Wearable Self-Contained Drug Infusion Device," each of which is incorporated herein by reference in its entirety. [0005]External pump type delivery devices may be connected in fluid-flow communication to a patient-user, for example, through a suitable hollow tubing. The hollow tubing may be connected to a hollow needle that is designed to pierce the patient-user's skin and deliver an infusion medium to the patient-user. Alternatively, the hollow tubing may be connected directly to the patient-user as or through a cannula. [0006]In contexts in which the hollow tubing is connected to the patient-user through a hollow needle that pierces the patient-user's skin, a manual insertion of the needle into the patient-user can be somewhat traumatic to the patient-user. Accordingly, insertion mechanisms have been made to assist the insertion of a needle into the patient-user, whereby a needle is forced by a spring to quickly move from a retracted position into an extended position. Examples of insertion mechanisms that are built into a delivery device are described in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled "Infusion Device And Method With Disposable Portion" (assigned to the assignee of the present invention), which is incorporated herein by reference in its entirety. Other examples of insertion tools are described in U.S. Patent Application Publication No. 2002/0022855, titled "Insertion Device For An Insertion Set And Method Of Using The Same" (assigned to the assignee of the present invention), which is incorporated herein by reference in its entirety. As the needle is moved into the extended position, the needle is quickly forced through the patient-user's skin in a single, relatively abrupt motion that can be less traumatic to a patient-user as compared to a slower, manual insertion of a needle. [0007]As compared to syringes and insulin pens, pump type delivery devices can be significantly more convenient to a patient-user, in that accurate doses of insulin may be calculated and delivered automatically to a patient-user 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 infusion medium at appropriate times of need, based on sensed or monitored levels of blood glucose. [0008]Pump type delivery devices have become an important aspect of modern medical treatments of various types of medical conditions, such as diabetes. As pump technologies improve and doctors and patient-users become more familiar with such devices, the popularity of external medical infusion pump treatment increases and is expected to increase substantially over the next decade. SUMMARY OF THE DISCLOSURE [0009]Embodiments of the present invention relate, generally, to delivery devices, systems and methods for delivering an infusion medium to a recipient, such as a medical patient. Such delivery devices may include first and second housing portions (referred to herein as a durable housing portion and a disposable housing portion, respectively) that are configured to engage and attach to each other for operation. The disposable housing portion may contain an infusion medium reservoir and other components that come into contact with the infusion medium and/or the patient-user during operation. The disposable housing portion may also contain a pump device in accordance with one of the embodiments described herein. The durable housing portion may contain or otherwise support components that do not come into contact with the infusion medium or the patient-user during normal operation of the delivery device, including, but not limited to, a drive device, drive linkage, electronic circuits and, in some embodiments, a power source. [0010]The disposable housing portion may be disengaged and separated from the durable housing portion, such that the disposable housing portion may be readily disposed of after it has been in use for a period of time, or after one or a prescribed number of uses. After disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, user-filled, prefilled, refilled or re-manufactured disposable housing portion) for further operation. [0011]Thus, a delivery device for delivering an infusion medium to a user according to example embodiments of the invention may include a disposable housing portion adapted to be secured to a user and a durable housing portion configured to be selectively engaged with and disengaged from the disposable housing portion, to allow disposal of the disposable housing portion without disposing of the durable housing portion. Delivery device embodiments described herein may employ any one of various pump embodiments described herein, to draw the infusion medium from the reservoir and/or convey the infusion medium to an injection site. [0012]For example, a delivery device as described herein may include a pump device supported by the disposable housing portion and arranged to be operatively driven by a drive device, through a drive shaft. The drive shaft may be supported by the durable housing portion, for movement in a first direction and in a second direction opposite to the first direction. The drive device may operatively connect to the drive shaft, to selectively move the drive shaft in the first direction to drive the pump device. [0013]The pump device according to an embodiment of the invention is provided with a piston chamber having an interior including a fluid portion having a variable volume for containing an infusion medium. An inlet port of the pump device is provided in fluid flow communication with the interior volume of the piston chamber. The inlet port is configured for connection with a reservoir, for fluid flow communication with the reservoir. [0014]An outlet port of the pump device is provided in fluid flow communication with interior volume of the piston chamber. A push plate is supported for back-and-forth movement in a first direction and in a second direction opposite to the first direction, where the push plate is arranged in a position for operative engagement with the drive shaft to move the push plate in the first direction as the drive shaft is moved in the first direction, and to allow movement of the push plate in the second direction as the drive shaft is moved in the second direction, when the disposable housing portion and the durable housing portion are engaged with each other. [0015]A piston head is supported for movement within the piston chamber between a retracted position and an active position to vary the volume of the fluid portion of the piston chamber. The piston head is operatively coupled in a fixed relation to the push plate, for movement from the retracted position to the active position with movement of the push plate in the first direction. When the piston chamber contains infusion fluid, the volume of the fluid portion of the piston chamber is reduced as the piston head is moved from the retracted position to the active position to provide a pressure within the piston chamber to force the infusion fluid from the fluid portion of the piston chamber and through the outlet port. Conversely, the volume of the fluid portion of the piston chamber is increased as the piston head is moved from the retracted position to the active position to provide a pressure within the piston chamber to draw infusion fluid into the fluid portion of the piston chamber, through the inlet port, when the inlet port is connected in fluid flow communication with a reservoir. [0016]The delivery device according to an embodiment of the invention includes a bias member operatively coupled to the push plate, for imparting a bias force on the push plate in the second direction sufficient to move the push plate in the second direction as the drive shaft is moved in the second direction, when the disposable housing portion and the durable housing portion are engaged with each other. In the same or further embodiments, the push plate is coupled to the piston head by a piston rod and the piston chamber is open to a channel section through which the piston rod extends. A seal is provided to inhibit fluid from passing through the channel section. [0017]In the same or further embodiments, the delivery device includes a reservoir having an interior volume for containing an infusion medium and a conduit connecting the interior volume of the reservoir in fluid flow communication with the inlet port of the pump device. The reservoir may be supported by the disposable housing portion. [0018]According to example embodiments, the disposable housing portion includes a housing structure that has an interior volume in which the pump device is located. Also, the housing structure of the disposable housing portion includes a wall having an opening. The push plate has a surface that is positioned to be acted upon by the drive shaft, through the opening in the wall of the housing structure of the disposable housing portion, when the disposable housing portion and the durable housing portion are engaged with each other. [0019]According to further example embodiments, the durable housing portion includes a housing structure having an interior volume in which the drive device is located. Also, the housing structure of the durable housing portion includes a wall having an opening through which the drive shaft extends. The drive shaft has an end that is positioned external to the durable housing portion for engaging the surface of the push plate, when the disposable housing portion and the durable housing portion are engaged with each other. [0020]According to another aspect of the invention, a pump device is provided for conveying an fluidic medium. The pump device has a piston chamber having an interior that includes a fluid portion having a variable-volume for containing a fluidic medium. An inlet port is provided in fluid flow communication with the interior volume of the piston chamber. The inlet port is configured for connection with a source of fluidic medium, for receiving fluid medium from the source into the interior volume of the piston chamber. An outlet port is provided in fluid flow communication with interior volume of the piston chamber. Continue reading... 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