Infusion device and method with disposable portion

• US 7,686,787 B2
• Filed: 08/23/2005
• Issued: 03/30/2010
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Moberg, Sheldon B., Hanson, Ian B., Cheney, Paul S. II
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Price; Nathan R
• Application Number:
  US11/211,095
• Publication Number:
  US 20060264894A1
• Time in Patent Office: 1,680 Days
• Field of Search: 604151-157, 604/174, 604/180, 604/890.1, 604/892.1, 604/66, 604/67, 604/289, 604/290, 604304-308, 604/310, 604/311
• US Class Current: 604/155
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2207/10 Device therefor
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14236 Screw, impeller or centrifugal type pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

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 and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media 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 infusion media from the reservoir and a drive device and drive linkage.

Claims

1. A delivery device for delivering an infusion media to a user, the device comprising:

a disposable housing portion adapted to be secured to a user;

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;

a reservoir for containing infusion media supported on the disposable housing portion;

electrical control circuitry contained in the durable housing portion, wherein the electrical control circuitry controls the delivery of infusion media from the reservoir to the user when the durable housing portion and the disposable housing portion are engaged;

the disposable housing portion comprising;

a base portion having a surface configured to be placed adjacent a user'"'"'s skin to adhere the base portion to the user'"'"'s skin;

a bladder containing a flowable agent;

a conduit structure connected to the bladder; and

an operator coupled to the bladder and operable by a user to selectively dispense the flowable agent from the bladder into the conduit structure;

the conduit structure having at least one opening adjacent the surface of the base portion and arranged to dispense the flowable agent from the conduit structure to a space between the surface of the base portion and the user'"'"'s skin, when the surface of the base portion is placed adjacent the user'"'"'s skin.

2. A delivery device according to claim 1, further comprising a movable needle supporting structure that allows for selective introduction of a needle into the user, for conveying infusion media from the reservoir into the user, the movable needle supporting structure being moveable relative to the disposable housing portion.

3. A delivery device according to claim 1, further comprising an adhesive material provided on the surface of the base portion for securing the disposable housing portion to the skin of the user.

4. A delivery device according to claim 1, wherein the

conduit structure comprises a plurality of conduits connected in fluid flow communication to the bladder;

and

the operator comprises a manual operator coupled to the bladder and operable by a user to dispense the flowable agent from the bladder into the conduits;

wherein the plurality of conduits have openings adjacent the surface of the base portion.

5. A delivery device according to claim 2, further comprising a hollow tube coupled to the moveable needle supporting structure, wherein the disposable housing portion further comprises an opening for connecting the hollow tube to the reservoir for conveying infusion media from the reservoir to the moveable needle supporting structure.

6. A delivery device according to claim 2, further comprising:

a hollow tube having first and second ends, the first end coupled to the moveable needle supporting structure; and

a connector having first and second engageable and disengageable connector members, the first connector member coupled to the second end of the hollow tube and the second connector member coupled to the reservoir, the connector coupling the hollow tube in fluid flow communication with the reservoir when the first and second connector members are engaged.

7. A delivery device according to claim 2, further comprising:

a hollow tube having first and second ends, the first end coupled to the moveable needle supporting structure; and

a connector for connecting the second end of the hollow tube in fluid-flow communication with the reservoir, wherein the connector comprises a threaded cap having a hollow needle for coupling to a corresponding reservoir connector structure.

8. A delivery device according to claim 7, wherein the corresponding reservoir connector structure comprises a septum for receiving an end of the hollow needle.

9. A delivery device according to claim 1, further comprising a sensor and a sensor lead connecting the sensor to the electrical control circuitry in the durable portion.

10. A delivery device according to claim 9, wherein the sensor comprises a biological or environmental sensing device.

11. A delivery device according to claim 10, wherein the sensor comprises a disposable needle pad that further comprises a needle for piercing the user'"'"'s skin and electronics reactive to a biological condition.

12. A delivery device according to claim 11, wherein the electrical control circuitry in the durable housing portion includes sensor electronics and wherein the disposable needle pad of the sensor is in electrical communication with the sensor lead to convey electrical signals from the sensor to the sensor electronics.

13. A delivery device according to claim 1, further comprising an adhesive material disposed on the surface of the base portion for adhering the base portion to the user'"'"'s skin when the surface of the base portion is placed adjacent the user'"'"'s skin.

14. A delivery device according to claim 13, where the flowable agent comprises an adhesive releasing agent and the at least one opening of the conduit structure is arranged to dispense adhesive releasing agent from the conduit structure to the adhesive material on the surface of the base portion, the adhesive releasing agent for reducing adhering qualities of the adhesive material.

15. A delivery device according to claim 1, where the flowable agent comprises an adhesive releasing agent and the at least one opening of the conduit structure is arranged to dispense adhesive releasing agent from the conduit structure to the surface of the base portion, the adhesive releasing agent for reducing adhering qualities of adhesive material on the surface of the base portion.

16. A method of assembling a delivery device, the method comprising:

providing a housing having a disposable housing portion with a base for arranging adjacent to a user, the housing also having a durable housing portion;

configuring the durable housing portion for attaching the durable housing portion to the disposable housing portion in a manner that allows a user to selectively detach the durable housing portion from the disposable housing portion;

supporting a reservoir for containing infusion media on the disposable housing portion;

containing electrical control circuitry in the durable housing portion for controlling the delivery of the infusion media from the reservoir to the user;

supporting a bladder with the housing;

containing a flowable agent in the bladder;

coupling a conduit structure in flow communication with the bladder;

coupling an operator to the bladder for selectively dispensing the flowable agent from the bladder into the conduit structure; and

arranging the conduit structure to dispense flowable agent from the conduit structure to a space between the surface of the base and the user'"'"'s skin, when the surface of the base is arranged adjacent the user'"'"'s skin.

17. A method as recited in claim 16, further comprising providing an adhesive material on the surface of the base of the disposable housing portion configured to be arranged against a user'"'"'s skin with the adhesive material between the surface of the base and the user'"'"'s skin, for securing the disposable housing portion to the skin of the user.

18. A method according to claim 16,

wherein coupling a conduit structure comprises coupling a plurality of conduits in flow communication with the bladder;

wherein coupling an operator comprises coupling a manual operator to the bladder for dispensing the flowable agent from the bladder into the plurality of conduits in response to a manual operation of the manual operator;

wherein the plurality of conduits have openings adjacent the surface of the base of the disposable housing portion.

19. A method as recited in claim 16, further comprising connecting a hollow tube to the reservoir for conveying infusion media from the reservoir to the user.

20. A method according to claim 16, further comprising:

connecting a needle supporting structure in fluid flow communication with the reservoir, the needle supporting structure for selective introduction of a needle into the user;

coupling a first end of a hollow tube to the needle supporting structure;

coupling a second end of the hollow tube to a first connector member of a connector; and

coupling a second connector member of a connector to the reservoir, the second connector member being engageable and disenageable with the first connector member of the connector, such that the connector couples the hollow tube in fluid flow communication with the reservoir when the first and second connector members are engaged.

21. A method according to claim 16, further comprising:

connecting a needle supporting structure in fluid flow communication with the reservoir, the needle supporting structure for selective introduction of a needle into the user;

coupling a first end of a hollow tube to the needle supporting structure; and

coupling a connector to the second end of the hollow tube, the connector for selectively coupling the second end of the hollow tube in fluid flow communication with the reservoir;

wherein the connector comprises a threaded cap having a hollow needle for coupling to a corresponding reservoir connector structure.

22. A method as recited in claim 16, further comprising connecting the durable portion to a biological or environmental sensor through a sensor lead.

23. A method according to claim 22, wherein the sensor comprises a disposable needle pad that further comprises a needle for piercing the user'"'"'s skin and electronics reactive to a biological condition.

24. A method according to claim 16, further comprising containing wireless communication electronics in the durable housing portion for providing wireless communication with a sensor located remote from the delivery device.

25. A method according to claim 16, further comprising connecting a biological sensor to the control electronics, the biological sensor for providing an electrical characteristic dependent upon a biological condition;

containing sensor electronics in the durable housing portion; and

connecting the sensor electronics to the biological sensor for sensing a biological condition based on the electrical characteristic of the biological sensor.

26. A method according to claim 16, further comprising providing an adhesive material on the base of the housing for adhering the base to the user'"'"'s skin, wherein the flowable agent comprises an adhesive releasing agent for reducing adhering qualities of the adhesive material on the base upon being dispensed to the space between the surface of the base and a user'"'"'s skin when the surface of the base is arranged adjacent the user'"'"'s skin.