Needle insertion systems and methods

• US 8,187,232 B2
• Filed: 09/30/2010
• Issued: 05/29/2012
• Est. Priority Date: 12/16/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chong, Colin A., Lorenzen, Eric M., Ibranyan, Arsen, Kavazov, Julian D., Bikovsky, Rafael
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US12/894,284
• Publication Number:
  US 20110022002A1
• Time in Patent Office: 607 Days
• Field of Search: 604/82, 604 86- 91, 604/164.01, 604/164.07, 604/164.08, 604/164.12, 604194-196, 604200-206, 604411-414
• US Class Current: 604/205
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/58 Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• 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 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• 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

A housing may have a needle, plunger, and bias mechanism supported within the housing by a tab configured to retain the plunger in position and to allow the plunger to move under bias force imparted by the bias mechanism to move the needle to an insert position when the tab is removed. A base and a structure may be configured for relative movement there between and may be adapted to be secured to a user with a cannula extending through a body of the structure into the user during use of a medical device. A housing may be adapted to be secured to a user to support a medical device operable with an insertion needle, the housing having a magnifying material for increasing visibility of an injection site.

Claims

1. A connecting structure for connecting a first member in fluid flow connection with a second member, the connecting structure comprising:

a receptacle structure provided on the first member and having an interior chamber and an opening into the interior chamber;

a first septum provided within the interior chamber, adjacent the opening of the receptacle structure;

a hollow needle supported within the interior chamber of the receptacle structure, the hollow needle having a sharp end with a first opening into which fluid may flow, the sharp end facing the first septum, the hollow needle having a second opening out of which fluid may flow;

a connection portion provided on the second member, the connection portion having a hollow interior chamber and an opening that opens to the hollow interior chamber, the connection portion having a size and shape suitable to be inserted at least partially into the opening of the receptacle structure;

a second septum supported by the connection portion of the second member in a position to cover the opening in the connection portion; and

a needle injection site structure provided on the first member, the needle injection site structure having a needle injection site channel in which an injection needle or cannula from a needle inserting device is moveable from a retracted position to an extended position, and a manifold arranged in fluid flow communication with the injection needle or cannula when the injection needle or cannula is in the extended position and out of fluid flow communication with the injection needle or cannula when the injection needle or cannula is in the retracted position;

the first septum having an end portion configured to be pierced by the hollow needle and a skirt structure extending from the end portion of the first septum, the skirt structure providing a bias force on the end portion of the first septum, the bias force being directed toward the opening of the receptacle structure;

wherein upon receiving the connection portion within the opening of the receptacle structure, the connection portion pushes the first septum toward the sharp end of the hollow needle against the bias force of the skirt structure, and the sharp end of the hollow needle is caused to pierce the first septum and the second septum to come into fluid flow communication with the hollow interior chamber of the connection portion; and

wherein the second opening of the hollow needle is provided in fluid flow communication with the manifold of the needle injection site structure.

2. A connecting structure as recited in claim 1, wherein:

the needle injection site channel has an opening that is connectable to an injection needle inserting device for receiving at least a portion of the injection needle or cannula from the needle inserting device when the injection needle or cannula is moved to the extended position.

3. A connecting structure as recited in claim 1, wherein the hollow needle extends through the skirt structure.

4. A connecting structure as recited in claim 1, wherein the second member comprises a fluid reservoir and wherein the connection portion of the second member comprises a portion of the fluid reservoir.

5. A connecting structure as recited in claim 1, wherein the receptacle structure is fixed with respect to a base portion and wherein the connection portion of the second member is provided in a housing that is connectable to the base portion.

6. A connecting structure as recited in claim 5, wherein the base portion includes structure for securing the receptacle structure to the skin of a user.

7. A connecting structure as recited in claim 5, wherein the base portion includes adhesive material for securing the base portion to the skin of a user.

8. A connecting structure as recited in claim 2, wherein:

the receptacle structure is fixed with respect to a base portion;

the connection portion of the second member is provided in a housing that is connectable to the base portion; and

the housing includes a recess through which a needle inserting device may extend when connected to the opening of the needle injection site channel.

9. A connecting structure as recited in claim 1, wherein the needle injection site channel has an opening that is connected to an injection needle inserting device for receiving at least a portion of the injection needle or cannula from the needle inserting device, the needle inserting device comprising:

a needle inserter housing having an internal chamber and a longitudinal dimension;

a plunger arranged for movement within the internal chamber, in the direction of the longitudinal dimension of the needle inserter housing, from a first plunger position to a second plunger position;

a plunger bias mechanism for imparting a bias force on the plunger when the plunger is in the first plunger position, wherein the bias force is directed toward the second plunger position;

the injection needle or cannula connected to the plunger, for movement with the plunger;

an insert structure arranged for movement within the internal chamber of the needle inserter housing with movement of the plunger from the first plunger position to the second plunger position;

wherein, upon movement of the plunger from the first plunger position to the second plunger position, the injection needle or cannula and insert structure are moved to an insert position with movement of the plunger to the second plunger position.

10. A connecting structure as recited in claim 9, wherein

the needle inserter housing has least one slot or groove;

and

the body of the insert structure includes a shaped portion that is configured to engage the at least one slot or groove, upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position.

11. A connecting structure as recited in claim 10, wherein:

the needle inserter housing has a flexible wall portion in the vicinity of the at least one slot or groove; and

the body of the insert structure is arranged to engage and outwardly flex the flexible wall portion of the needle inserter housing, upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position.

12. A connecting structure as recited in claim 1, wherein the connection portion on the second member has an end surface arranged to abut the first septum and push the first septum against the bias force of the skirt structure upon the connection portion being received within the opening of the receptacle structure, wherein the second septum is recessed within the hollow interior chamber of the connection portion relative to the end surface of the connection portion.

13. A connecting structure as recited in claim 1, wherein the connection portion on the second member has an end surface arranged to directly contact the first septum and push the first septum against the bias force of the skirt structure upon the connection portion being received within the opening of the receptacle structure.

14. A connecting structure as recited in claim 13, the end surface of the connection portion is out of contact with the second septum.

15. A connecting structure as recited in claim 1, the skirt structure being integral with the end portion of the first septum.

16. A connecting structure as recited in claim 1, the skirt structure having an open interior in which at least a portion of the length of the hollow needle extends.

17. A connecting structure as recited in claim 1, the skirt structure having a natural or built-in spring force that biases the end portion of the first septum toward the opening of the receptacle structure.

18. A connecting structure as recited in claim 1, wherein the manifold has an interior volume that is open to the needle injection site channel.

19. A connecting structure as recited in claim 1, wherein the receptacle structure includes a wall arranged on an opposite side of the interior chamber relative to the opening, wherein the hollow needle extends through the wall of the receptacle structure, and wherein the wall of the receptacle structure has a first surface facing into the interior chamber of the receptacle structure and a second surface facing into an interior volume of the manifold.

20. A connecting structure as recited in claim 1, wherein the first member has a base adapted to be arranged adjacent a user'"'"'s skin and wherein the needle injection site structure includes an opening through the base, through which the injection needle or cannula extends when the injection needle or cannula is in the extended position, to pierce the user'"'"'s skin when the base is arranged adjacent the user'"'"'s skin.

21. A method of connecting a first member in fluid flow connection with a second member, the method comprising:

providing a receptacle structure on the first member, the receptacle structure having an interior chamber and an opening into the interior chamber;

providing a first septum within the interior chamber, adjacent the opening of the receptacle structure, the first septum having an end portion configured to be pierced by the hollow needle and a skirt structure extending from the end portion of the first septum, the skirt structure providing a bias force on the end portion of the first septum, the bias force being directed toward the opening of the receptacle structure;

supporting a hollow needle within the interior chamber of the receptacle structure, the hollow needle having a sharp end with a first opening into which fluid may flow, the sharp end facing the first septum, the hollow needle having a second opening out of which fluid may flow;

providing a needle injection site structure on the first member, the needle injection site structure having a needle injection site channel in which an injection needle or cannula from a needle inserting device is moveable from a retracted position to an extended position, and a manifold arranged in fluid flow communication with the injection needle or cannula when the injection needle or cannula is in the extended position and out of fluid flow communication with the injection needle or cannula when the injection needle or cannula is in the retracted position;

arranging the second opening of the hollow needle in fluid flow communication with the manifold of the needle injection site structure;

providing a connection portion on the second member, the connection portion having a hollow interior chamber and an opening that opens to the hollow interior chamber, the connection portion having a size and shape suitable to be inserted at least partially into the opening of the receptacle structure;

supporting a second septum by the connection portion of the second member in a position to cover the opening in the connection portion; and

inserting the connection portion within the opening of the receptacle structure, to cause the connection portion to push the first septum toward the sharp end of the hollow needle against the bias force of the skirt structure, to cause the sharp end of the hollow needle to pierce the first septum and the second septum and come into fluid flow communication with the hollow interior chamber of the connection portion.

22. A method as recited in claim 21, further comprising:

providing an opening in the needle injection site channel that is connectable to an injection needle inserting device for receiving at least a portion of the injection needle or cannula from the needle inserting device when the injection needle or cannula is moved to the extended position.

23. A method as recited in claim 21, wherein the method further comprises extending the hollow needle through the skirt structure.

24. A method as recited in claim 21, further comprising affixing the receptacle structure to a base portion and providing the connection portion in a housing that is connectable to the base portion.

25. A method as recited in claim 21, further comprising:

providing an opening in the needle injection site channel;

connecting the opening in the needle injection site channel to an injection needle inserting device for receiving at least a portion of the injection needle or cannula from the injection needle inserting device;

supporting a plunger for movement along a longitudinal dimension of an internal chamber of a housing of the injection needle inserting device, from a first plunger position to a second plunger position;

imparting a bias force on the plunger when the plunger is in the first plunger position, wherein the bias force is directed toward the second plunger position;

supporting the injection needle or cannula on the plunger, for movement with the plunger;

moving an insert structure within the internal chamber of the needle inserter housing with movement of the plunger from the first plunger position to the second plunger position;

wherein, upon movement of the plunger from the first plunger position to the second plunger position, the injection needle or cannula and insert structure are moved to an insert position with movement of the plunger to the second plunger position.

26. A method as recited in claim 25, wherein

providing the injection needle inserting device with a housing having at least one slot or groove;

and

engaging the at least one slot or groove with a shaped portion of the body of the insert structure, upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position.

27. A method as recited in claim 26, wherein:

providing the injection needle inserter housing with a flexible wall portion in the vicinity of the at least one slot or groove; and

engaging and outwardly flexing the flexible wall portion of the injection needle inserter housing with the body of the insert structure, upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position.