Infusion medium delivery system, device and method with needle inserter and needle inserter device and method

• US 7,736,338 B2
• Filed: 12/26/2006
• Issued: 06/15/2010
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Kavazov, Julian D., Hanson, Ian B., Mounce, R. Paul
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US11/646,052
• Publication Number:
  US 20080051718A1
• Time in Patent Office: 1,267 Days
• Field of Search: 604/164.01
• US Class Current: 604/164.01
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2005/3289 with rotation of the needle, e.g. to ease penetration
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, includes a needle inserter device and method for inserting a needle and/or cannula into a patient-user to convey the infusion medium to the patient-user. The needle inserter device and method operate to insert a needle and cannula into a patient-user'"'"'s skin and automatically withdraw the needle from the patient-user, leaving the cannula in place and in fluid flow communication with a reservoir. The delivery device may include 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 the reservoir and the needle inserter device, while the durable portion supports a drive device for selectively driving the infusion medium out of the reservoir and into the needle and/or cannula.

Claims

1. A needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a housing having an interior surface surrounding a generally hollow interior volume that is in a generally cylindrical shape having a first end and a second end, the interior surface having a central axis that passes through the first end and the second end of the generally cylindrical shaped interior volume, the interior surface having an inner circumference, a first groove forming a generally spiral path around at least a portion of the inner circumference and a second groove extending in a generally linear path that is generally parallel to the central axis;

a moveable cam member supported for movement within the interior volume of the housing between a retracted position and an extended position, the cam member having a projection for extending into the first and second grooves, the cam member for supporting a needle for movement with the cam member between the retracted position and extended position;

wherein when the moveable cam is in the retracted position the needle is within the generally hollow interior volume of the housing;

wherein when the moveable cam is in the extended position a portion of the needle extends out of the housing;

at least one bias member for imparting on the moveable cam member, a rotary force around the central axis, and a linear force in a direction parallel to the central axis, the rotary force is applied on the moveable cam member and moves the moveable cam member along the spiral path and the linear force is applied in a direction toward the retracted position;

a stop structure for engaging and holding the moveable cam member in the retracted position;

wherein, when the moveable cam member is held in the retracted position by the stop surface, the moveable cam member that selectively disengages from the stop structure and moves from the retracted position to the extended position, in a rotary direction around the central axis and simultaneously in a direction generally parallel to the central axis, while the cam projection follows the spiral path of the first groove;

wherein the projection of the cam member engages the spiral path of the first groove due to the rotary force of the at least one bias member when the cam member is pushed toward the extended position; and

wherein, when the moveable cam member is in the extended position, the moveable cam member moves from the extended position toward the retracted position, in a generally linear direction that is generally parallel to the central axis, while the cam projection follows the generally linear path of the second groove due to the linear force applied by the at least one bias member.

2. A device according to claim 1, wherein the generally linear path is continuous and connects to the generally spiral path adjacent to the first end and adjacent to the second end of the housing.

3. A device according to claim 2, wherein the generally linear path of the second groove has an extension portion that extends toward the first end of the housing a distance beyond the generally spiral path of the first groove and wherein the stop structure comprises a surface of the housing along the extension portion of the second groove.

4. A device according to claim 1, further comprising a needle having a shaft having a piercing end, the needle supported for movement with the cam member such that the piercing end of the needle extends out of the housing, when the cam member is in the extended position.

5. A device according to claim 1, wherein:

the first end of the housing is positioned adjacent a user'"'"'s skin;

the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, while supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user'"'"'s skin, when (i) the first end of the housing is positioned adjacent the user'"'"'s skin, (ii) the moveable needle and cannula are in the extended position and (iii) the moveable cam member is moved from the extended position toward the retracted position, while the cam projection follows the generally linear path of the second groove.

6. A device according to claim 1, wherein the at least one bias member comprises a coil spring having a first end fixed relative to the cam member and a second end fixed relative to the housing, adjacent one end of the housing.

19. A device according to claim 1, wherein

the at least one bias member comprises a coil spring at least partially wound up relative to its natural winding state when the moveable cam member is in the retracted position or is being moved from the retracted position to the extended position, to provide the rotary force in an unwinding direction of the coil spring;

and

the coil spring is compressed against its natural linear state when the moveable cam member is in the extended position, to provide a linear force on the moveable cam member to move the moveable cam member toward the retracted position in the generally linear direction, while the cam projection follows the generally linear path of the second groove.

20. A device according to claim 1, wherein the at least one bias member comprises a coil spring wound against its natural state to provide the rotary force in an unwinding direction of the coil spring when the moveable cam member is in the retracted position or is being moved from the retracted position to the extended position.

23. A device according to claim 1, wherein one bias member of the at least one bias member imparts both the rotary force and the linear force.

24. A device according to claim 1, wherein the linear force of the at least one bias member pushes the moveable cam member from the extended position to the retracted position along the linear path.

25. A device according to claim 2, wherein the moveable cam member is at the first end of the housing when the cam member is in a retracted position.

26. A device according to claim 23, wherein the first grove with the spiral path has a wider opening at the first end of the housing than the first grove opening at the second end of the housing.

7. A needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a housing having a generally cylindrical interior surface surrounding a generally cylindrical hollow interior volume having a first end and a second end, the generally cylindrical interior surface having a central axis that passes through the first and second ends of the generally cylindrical shaped interior volume, the interior surface having and an inner circumference;

a moveable cam member supported for movement within the interior volume of the housing between a retracted position and an extended position, wherein either one of the interior surface of the housing or the cam member has a groove and the other has a projection for extending within the groove, and wherein the groove or projection on the interior surface of the housing forms a generally spiral first path around at least a portion of the inner circumference of the interior surface of the housing and a generally linear second path that is generally parallel to the central axis;

wherein when the moveable cam is in the retracted position the needle occupies the generally hollow interior volume of the housing;

wherein when the moveable cam is in the extended position portions of the needle extend out of the housing;

at least one bias member for imparting on the moveable cam member, a rotary force around the central axis and a linear force in a direction parallel to the central axis, the rotary force applied on the moveable cam member to move the moveable cam member along the spiral path and the linear force is applied in a direction toward the retracted position;

a stop structure for engaging and holding the moveable cam member in the retracted position;

wherein, when the moveable cam member is held in the retracted position by the stop surface, the moveable cam member that selectively disengages from the stop structure and moves from the retracted position to the extended position, in a rotary direction around the central axis and simultaneously in a direction generally parallel to the central axis, while the groove or projection on the cam member follows the spiral first path;

wherein the projection is configured to engage the spiral path of the first groove due to the rotary force of the at least one bias member when the cam member is pushed toward the extended position; and

wherein, when the moveable cam member is in the extended position, the moveable cam member moves from the extended position toward the retracted position, in a generally linear direction that is generally parallel to the central axis, while the groove or projection on the cam member follows the generally linear second path.

8. A device as recited in claim 7, wherein the cam member has the projection and the interior surface of the housing has the groove and wherein the first path comprises a generally spiral-shaped groove in the interior surface of the housing and the second path comprises a generally linear groove in the interior surface of the housing.

9. A device as recited in claim 8, wherein the generally linear groove connects to the generally spiral groove adjacent each end of the housing.

11. A device according to claim 7, further comprising a needle having a shaft having a piercing end, the needle supported for movement with the cam member such that the piercing end of the needle extends out of the housing, when the cam member is in the extended position.

12. A device according to claim 7, wherein:

the first end of the housing is positioned adjacent a user'"'"'s skin;

the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, while supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user'"'"'s skin, when (i) the first end of the housing is positioned adjacent the user'"'"'s skin, (ii) the moveable needle and cannula are in the extended position and (iii) the moveable cam member is moved from the extended position toward the retracted position.

13. A device according to claim 7, wherein the at least one bias member comprises a coil spring having a first end fixed relative to the cam member and a second end fixed relative to the housing, adjacent one end of the housing.

21. A device according to claim 7, wherein

the at least one bias member comprises a coil spring at least partially wound up relative to its natural winding state when the moveable cam member is in the retracted position or is being moved from the retracted position to the extended position, to provide the rotary force in an unwinding direction of the coil spring;

and

the coil spring is compressed against its natural linear state when the moveable cam member is in the extended position, to provide a linear force on the moveable cam member to move the moveable cam member toward the retracted position in the generally linear direction, while the cam projection follows the generally linear second path.

22. A device according to claim 7, wherein the at least one bias member comprises a coil spring wound against its natural state to provide the rotary force in an unwinding direction of the coil spring when the moveable cam member is in the retracted position or is being moved from the retracted position to the extended position.

10. A needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a housing having a generally cylindrical interior surface surrounding a generally cylindrical hollow interior volume having a first end and a second end, the generally cylindrical interior surface having a central axis that passes through the first end and the second end of the generally cylindrical interior volume, the interior surface having and an inner circumference;

a moveable cam member supported for movement within the interior volume of the housing between a retracted position and an extended position, wherein either one of the interior surface of the housing or the cam member has a groove and the other has a projection for extending within the groove, and wherein the groove or projection on the interior surface of the housing forms a generally spiral first path around at least a portion of the inner circumference of the interior surface of the housing and a generally continuous linear second path that is generally parallel to the central axis;

wherein when the moveable cam is in the retracted position the needle is within the generally hollow interior volume of the housing;

wherein when the moveable cam is in the extended position portions of the needle extend out of the housing;

at least one bias member for imparting on the moveable cam member, a rotary force around the central axis, the rotary force is applied on the moveable cam member to move the moveable cam member along the spiral path and a linear force in a direction parallel to the central axis, the linear force is applied in a direction toward the retracted position;

a stop structure for engaging and holding the moveable cam member in the retracted position;

wherein, when the moveable cam member is held in the retracted position by the stop surface, the moveable cam member that selectively disengages from the stop structure and moves from the retracted position to the extended position, in a rotary direction around the central axis and simultaneously in a direction generally parallel to the central axis, while the groove or projection on the cam member follows the spiral first path;

wherein the projection of the cam member is configured to engage the spiral path of the first groove due to the rotary force of the at least one bias member when the cam member when the cam member is pushed toward the extended position; and

wherein, when the moveable cam member is in the extended position, the moveable cam member moves from the extended position toward the retracted position, in a generally linear direction that is generally parallel to the central axis, while the groove or projection on the cam member follows the generally continuous linear second path; and

wherein the generally continuous linear second path connects to the generally spiral first path adjacent each end of the housing.

14. A needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a housing having a generally hollow interior volume and a generally linear channel;

a rotary cam member supported for rotary movement about an axis of rotation within the interior volume of the housing, the rotary cam member having a cam surface that is at an obtuse angle relative to the axis of rotation;

a needle carriage supported for movement within the housing between a retracted position and an extended position;

a cannula secured to the needle carriage for movement with the needle carriage between the retracted position and the extended position of the needle carriage;

a needle having a shaft that extends through the cannula and provided with a piercing end and a second, opposite end, the second end of the needle is attached to the cam surface, during rotary movement of the cam member about the central axis, for moving the needle carriage and cannula from the retracted position to the extended position upon rotation of the rotary cam member;

a coupler for coupling the needle carriage in the extended position, upon movement of the needle carriage and cannula to the extended position; and

a bias member operatively connected to the rotary cam member, to impart a rotational force on the rotary cam, to selectively move the needle between the retracted position and the extended position.

15. A device according to claim 14, further comprising a releasable lock structure that holds at least one of the bias member and the rotary cam member against the rotational force of the bias member and to be selectively released to allow the bias member to rotate the rotary cam member about the axis of rotation.

16. A device according to claim 14, wherein the housing has a base having an aperture through which the needle extends, when the needle is in the extended position.

17. A device according to claim 14, wherein:

the first end of the housing is positioned adjacent a user'"'"'s skin;

the needle head is secured to the cam surface; and

the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, while supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user'"'"'s skin, when (i) the first end of the housing is positioned adjacent the user'"'"'s skin, (ii) the moveable needle and cannula are in the extended position and (iii) the rotary cam member is rotated to pull the needle from the extended position to ward the retracted position.

18. A device according to claim 14, wherein the bias member comprises a coil spring having a first end fixed relative to the rotary cam member and a second end that is fixed relative to the housing.