Needle inserter and method for infusion device

• US 7,955,305 B2
• Filed: 08/23/2005
• Issued: 06/07/2011
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Cheney, Paul S. II, Moberg, Sheldon B., Hanson, Ian B.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/211,157
• Publication Number:
  US 20060264890A1
• Time in Patent Office: 2,114 Days
• Field of Search: 604/131, 6048901-8921, 604151-155, 604134-139, 604/164.01, 604/164.11, 604/164.12, 604/165.01, 604/171, 604/174, 604/175, 604/180, 600431-435
• US Class Current: 604/164.01
• 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

An infusion media delivery device includes a housing having a base adapted to be secured to a user'"'"'s skin. An infusion media reservoir is supported by the housing. A moveable hollow needle is selectively engageable with the reservoir to communicate infusion media from the reservoir. The needle is supported for movement relative to the housing base between a first position and a second position. The needle is spaced apart from a user'"'"'s skin when in the first position and the base is secured to the user'"'"'s skin, and the needle is arranged to pierce the user'"'"'s skin when in the second position and the base is secured to the user'"'"'s skin.

Claims

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

a housing having a base adapted to be secured to a user'"'"'s skin;

a moveable hollow needle supported for movement relative to the base of the housing between a first position and a second position, wherein the moveable hollow needle is spaced apart from a user'"'"'s skin when the needle is in the first position and the base of the housing is secured to the user'"'"'s skin, and wherein the moveable hollow needle is arranged to pierce the user'"'"'s skin when the needle is in the second position and the base of the housing is secured to the user'"'"'s skin;

an infusion medium flow path for coupling a reservoir in fluid flow communication with the moveable hollow needle when the moveable hollow needle is in the second position;

a rotary valve in the infusion medium flow path, the rotary valve rotatable from a closed valve position inhibiting infusion medium from flowing from the reservoir to the moveable hollow needle, to an open valve position allowing infusion medium to flow from the reservoir to the moveable hollow needle;

a manual operator supported for movement and operably coupled to the rotary valve, to rotate the rotary valve by manual movement of the manual operator; and

a spring and latch structure operatively coupled to the moveable hollow needle, for imparting a spring force on the moveable hollow needle in a direction toward the second position and selectively latching the moveable hollow needle in the first position against the spring force;

wherein the manual operator is moveable to selectively unlatch the moveable hollow needle to allow the moveable hollow needle to move to the second position by operation of the spring force; and

wherein the manual operator comprises a rotatable member having a catch, wherein the rotatable member is supported for rotation between a first catch position and a second catch position, wherein the catch of the rotatable member is located for engaging the spring and inhibiting the spring from moving the moveable hollow needle when the moveable hollow needle is in the first position and the rotatable member is in the first catch position, and wherein the catch of the rotatable member is disengaged from the spring to allow the spring to move the moveable hollow needle toward the second position when the rotatable member is rotated from the first catch position to the second catch position.

2. A delivery device according to claim 1, wherein the housing comprises a disposable housing portion 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, the base being part of the disposable housing portion and the reservoir being supported by the disposable housing portion.

3. A delivery device according to claim 2, further comprising 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.

4. A delivery device according to claim 2, further comprising electrical control circuitry and a drive device contained in the durable housing portion, wherein the electrical control circuitry controls the delivery of infusion media from the reservoir to the user and wherein the drive device operatively couples to the reservoir to drive infusion media from the reservoir under control of the electrical control circuitry when the durable housing portion is engaged with the disposable housing portion.

6. A delivery device according to claim 1, wherein the manual operator comprises at least one pivotal lever pivotal between first and second pivot positions and having an engaging portion for engaging the spring and inhibiting the spring from moving the moveable hollow needle when the moveable hollow needle is in the first position and the pivotal lever is in the first pivot position, and wherein the engaging portion of the pivotal lever is disengaged from the spring to allow the spring to move the moveable hollow needle toward the second position when the pivotal lever is pivoted from the first pivot position to the second pivot position.

7. A delivery device according to claim 6, wherein the at least one pivotal lever comprises a pair of pivotal levers.

8. A delivery device according to claim 6, wherein the spring comprises a coil spring that is compressed when the moveable hollow needle is in the first position and expands to move the moveable hollow needle toward the second position when the pivotal lever is pivoted to disengage the engaging portion of the pivotal lever from the spring.

9. A delivery device according to claim 1, wherein the spring comprises a coil spring that is compressed when the moveable hollow needle is in the first position and expands to move the moveable hollow needle toward the second position when the rotatable member is rotated to disengage the catch of the rotatable member from the spring.

14. A delivery device according to claim 1, wherein the hollow needle has a side opening that comes into flow communication with the flow path when the moveable hollow needle moves to the second position.

25. A delivery device according to claim 1, wherein the manual operator is supported for manual rotation and is coupled to the rotary valve to transmit manual rotational motion of the manual operator to rotation of the valve between closed and open valve positions.

26. A delivery device according to claim 1, wherein the manual operator configured to detach from the rotary valve when the valve is in an open valve position and to remain detached while the valve remains in an open valve position to allow infusion medium to flow from the reservoir to the moveable hollow needle.

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

a housing having a base adapted to be secured to a user'"'"'s skin;

a reservoir for containing infusion media, wherein the reservoir is supported by the housing; and

a moveable hollow needle selectively engageable with the reservoir for communication of infusion media from the reservoir, the moveable hollow needle being supported by the housing for movement relative to the base of the housing between a first position and a second position, wherein the moveable hollow needle is spaced apart from a user'"'"'s skin when the needle is in the first position and the base of the housing is secured to the user'"'"'s skin, and wherein the moveable hollow needle has a first end that is arranged to pierce the user'"'"'s skin when the needle is in the second position and the base of the housing is secured to the user'"'"'s skin, and the moveable hollow needle has a second end that is arranged external to the reservoir when the needle is in the second position;

wherein the reservoir comprises a container and a septum, the septum is aligned with the first end of the moveable hollow needle and the first end of the moveable hollow needle pierces the septum as the moveable hollow needle is moved from the first position to the second position.

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

a housing having a base adapted to be secured to a user'"'"'s skin;

a reservoir for containing infusion media, wherein the reservoir is supported by the housing;

a moveable hollow needle selectively engageable with the reservoir for communication of infusion media from the reservoir, the moveable hollow needle being supported by the housing for movement relative to the base of he housing between a first position and a second position, wherein the moveable hollow needle is spaced apart from a user'"'"'s skin when the needle is in the first position and the base of the housing is secured to the user'"'"'s skin, and wherein the moveable hollow needle is arranged to pierce the user'"'"'s skin when the needle is in the second position and the base of the housing is secured to the user'"'"'s skin;

a spring and latch structure operatively coupled to the moveable hollow needle, for imparting a spring force on the moveable hollow needle in a direction toward the second position and selectively latching the moveable hollow needle in the first position against the spring force;

wherein the latch structure comprises a manual operator to selectively unlatch the moveable hollow needle to allow the moveable hollow needle to move to the second position by operation of the spring force;

wherein the manual operator comprises a rotatable member having a catch, wherein the rotatable member is supported for rotation between a first catch position and a second catch position, wherein the catch of the rotatable member is located for engaging the spring and inhibiting the spring from moving the moveable hollow needle when the moveable hollow needle is in the first position and the rotatable member is in the first catch position, and wherein the catch of the rotatable member is disengaged from the spring to allow the spring to move the moveable hollow needle toward the second position when the rotatable member is rotated from the first catch position to the second catch position; and

wherein reservoir has an infusion medium flow path in flow communication with the moveable hollow needle when the moveable hollow needle is in the second position and wherein the rotatable member includes a valve extending into the flow path, the valve having a closed state inhibiting infusion medium from flowing from the reservoir to the moveable hollow needle when the rotatable member is in the first catch position and the valve having an open state allowing infusion medium to flow from the reservoir to the moveable hollow needle when the rotatable member is in the second catch position.

11. A delivery device according to claim 10, wherein the hollow needle has a side opening in flow communication with the flow path of the reservoir when the moveable hollow needle is in the second position.

12. A delivery device according to claim 10, wherein the reservoir further includes a septum that is pierced by the moveable hollow needle when the moveable hollow needle moves to the second position and wherein the hollow needle has a side opening that comes into flow communication with the flow path of the reservoir when the moveable hollow needle moves to the second position.

13. A delivery device according to claim 10, wherein the hollow needle has a side opening in flow communication with the flow path of the reservoir when the moveable hollow needle is in the second position.

15. A method for delivering an infusion media to a user, the method comprising:

providing a housing having a base adapted to be secured to a user'"'"'s skin;

supporting a moveable hollow needle for movement relative to the base of he housing between a first position and a second position, wherein the moveable hollow needle is spaced apart from a user'"'"'s skin when the needle is in the first position and the base of the housing is secured to the user'"'"'s skin, and wherein the moveable hollow needle is arranged to pierce the user'"'"'s skin when the needle is in the second position and the base of the housing is secured to the user'"'"'s skin;

providing an infusion medium flow path for coupling a reservoir in fluid flow communication with the moveable hollow needle when the moveable hollow needle is in the second position;

arranging a rotary valve in the infusion medium flow path, for rotation from a closed valve position inhibiting infusion medium from flowing from the reservoir to the moveable hollow needle, to an open valve position allowing infusion medium to flow from the reservoir to the moveable hollow needle;

supporting a manual operator for movement and operably coupling the manual operator to the rotary valve, to rotate the rotary valve by manual movement of the manual operator;

coupling a spring and latch structure to the moveable hollow needle, for imparting a spring force on the moveable hollow needle in a direction toward the second position and selectively latching the moveable hollow needle in the first position against the spring force;

wherein the manual operator is moveable to selectively unlatch the moveable hollow needle to allow the moveable hollow needle to move to the second position by operation of the spring force;

wherein the manual operator comprises a rotatable member having a catch; and

wherein the method further comprises supporting the rotatable member for rotation between a first catch position and a second catch position; and

locating the catch of the rotatable member for engaging the spring and inhibiting the spring from moving the moveable hollow needle when the moveable hollow needle is in the first position and the rotatable member is in the first catch position, and disengaging from the spring to allow the spring to move the moveable hollow needle toward the second position when the rotatable member is rotated from the first catch position to the second catch position.

16. A method according to claim 15, wherein providing a housing comprises providing a disposable housing portion and a durable housing portion, and selectively engaging and disengaging the durable housing portion with the disposable housing portion to allow disposal of the disposable housing portion without disposing of the durable housing portion, the base being part of the disposable housing portion.

17. A method according to claim 16, further comprising containing electrical control circuitry in the durable housing portion, wherein the electrical control circuitry controls the delivery of infusion media from the reservoir to the user.

18. A method according to claim 16, further comprising containing electrical control circuitry and a drive device in the durable housing portion, wherein the electrical control circuitry controls the delivery of infusion media from the reservoir to the user;

and operatively coupling the drive device to the reservoir to drive infusion media from the reservoir under control of the electrical control circuitry when the durable housing portion is engaged with the disposable housing portion.

20. A method according to claim 15, wherein supporting a manual operator comprises supporting at least one pivotal lever pivotal between first and second pivot positions, providing the pivotal lever with an engaging portion for engaging the spring and inhibiting the spring from moving the moveable hollow needle when the moveable hollow needle is in the first position and the pivotal lever is in the first pivot position, and wherein the engaging portion of the pivotal lever is disengaged from the spring to allow the spring to move the moveable hollow needle toward the second position when the pivotal lever is pivoted from the first pivot position to the second pivot position.

21. A method according to claim 20, wherein supporting at least one pivotal lever comprises supporting a pair of pivotal levers.

22. A method according to claim 15, further comprising supporting a reservoir having an infusion medium flow path in flow communication with the moveable hollow needle when the moveable hollow needle is in the second position and wherein providing a manual operator comprises providing a rotatable member having a valve extending into the flow path, the valve having a closed state inhibiting infusion medium from flowing from the reservoir to the moveable hollow needle when the rotatable member is in the first catch position and the valve having an open state allowing infusion medium to flow from the reservoir to the moveable hollow needle when the rotatable member is in the second catch position.

23. A method according to claim 22, wherein the hollow needle has a side opening in flow communication with the flow path of the reservoir when the moveable hollow needle is in the second position.

24. A method according to claim 15, wherein the hollow needle has a side opening that comes into flow communication with the container of the reservoir when the moveable hollow needle moves to the second position.

19. A method for delivering an infusion media to a user, the method comprising:

providing a housing having a base adapted to be secured to a user'"'"'s skin;

supporting a reservoir by the housing, the reservoir for containing an infusion media; and

supporting a moveable hollow needle for selective engagement with the reservoir for communication of infusion media from the reservoir, including supporting the moveable hollow needle for movement relative to the base of the housing between a first position and a second position, wherein the moveable hollow needle is spaced apart from a user'"'"'s skin when the needle is in the first position and the base of the housing is secured to the user'"'"'s skin, and wherein the moveable hollow needle has a first end that is arranged to pierce the user'"'"'s skin when the needle is in the second position and the base of the housing is secured to the user'"'"'s skin, and the moveable hollow needle has a second end that is arranged external to the reservoir when the needle is in the second position;

wherein the reservoir comprises a container and a septum, the method further comprising aligning the septum with the first end of the moveable hollow needle and piercing the septum with the first end of the moveable hollow needle as the moveable hollow needle is moved from the first position to the second position.