Needle insertion systems and methods

• US 9,370,621 B2
• Filed: 12/16/2008
• Issued: 06/21/2016
• Est. Priority Date: 12/16/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Hanson, Ian B., Kavazov, Julian D., Bikovsky, Rafael
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US12/336,367
• Publication Number:
  US 20100152658A1
• Time in Patent Office: 2,744 Days
• Field of Search: 604/164.01, 604/164.07, 604/164.08, 604/164.12, 604194-196
• US Class Current: 1/1
• 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 needle-inserting device comprising:

a housing having a flexible portion, an internal chamber, a longitudinal dimension, and an internal surface having an angled, ramped or wedge-shaped portion;

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

a 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; and

a needle connected to the plunger for movement with the plunger; and

a tab connected to or integral with and the plunger and carried by the plunger, the tab having a tab end configured to retain the plunger in the first plunger position, the tab end moveable relative to the housing;

an insert structure arranged for movement within the internal chamber of the housing with movement of the plunger from the first plunger position to the second plunger position, the insert structure including a body through which the needle extends, wherein at least one of the plunger or the body of the insert structure is arranged to engage the angled, ramped or wedge-shaped portion of the housing and outwardly flex the flexible portion of the housing upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position;

wherein upon movement of the tab end, the plunger is released from being retained in the first plunger position by the tab end and moves with the tab end, relative to the housing, in the direction of the longitudinal dimension of the housing from the first plunger position to the second plunger position under the bias force imparted by the bias mechanism to move the needle to an insert position and outwardly flex the flexible portion of the housing.

2. The needle-inserting device of claim 1, wherein the bias mechanism comprises a chemical substance that expands upon application of another substance or energy from an energy source.

3. The needle-inserting device of claim 1, wherein the tab end is integral with the plunger, but fractures to break off from the plunger upon being moved to release the plunger from being retained in the first plunger position.

4. The needle-inserting device of claim 1, wherein the tab end is located outside of the internal chamber of the housing when the plunger is retained in the first plunger position, and the entire plunger is arranged within the internal chamber of the housing when the plunger is retained in the first plunger position.

5. The needle-inserting device of claim 1, wherein the tab end is located outside of the internal chamber of the housing when the plunger is retained in the first plunger position, the entire plunger and all portions of the tab other than the tab end are arranged within the internal chamber of the housing when the plunger is retained in the first plunger position, and the entire tab end is moveable relative to the housing to detach from the plunger and all portions of the tab arranged within the internal chamber of the housing.

6. The needle-inserting device of claim 1, wherein all portions of the tab other than the tab end are arranged within the internal chamber of the housing when the plunger is retained in the first plunger position, and wherein the entire tab end is moveable relative to the housing to detach from all portions of the tab arranged within the internal chamber of the housing.

7. The needle-inserting device of claim 1,

wherein at least a portion of the needle is adapted to pierce skin of a user as the plunger moves from the first plunger position to the second plunger position to move the needle to the insert position.

8. The needle-inserting device of claim 1,

the housing having an opening that opens to the internal chamber, the opening having a width dimension;

the tab end having a width dimension larger than the width dimension of the opening.

9. The needle-inserting device of claim 8,

the tab end configured to be one of rotatable and twistable to fit within the opening of the housing to release the plunger from being retained in the first plunger position.

10. The needle-inserting device of claim 8,

the tab end configured to be compressible to fit within the opening of the housing to release the plunger from being retained in the first plunger position.

11. The needle-inserting device of claim 8, wherein the tab end is located on one side of the opening of the housing prior to the tab end being moved to release the plunger, the tab end passing through the opening of the housing when the tab end is moved to release the plunger head from being retained in the first plunger position.

12. The needle-inserting device of claim 1, the device further comprising:

a hollow cannula having a hollow interior and arranged with the needle extending through the hollow interior;

wherein upon movement of the tab end, the plunger is free to move from the first plunger position to the second plunger position under the bias force imparted by the bias mechanism to move the hollow cannula to a cannula insert position.

13. The needle-inserting device of claim 12, wherein at least a portion of the cannula is adapted to pierce skin of a user as the plunger moves from the first plunger position to the second plunger position to move the cannula to the cannula insert position.

14. The needle-inserting device of claim 1, the device further comprising:

an insert structure arranged for movement within the internal chamber of the housing with movement of the plunger from the first plunger position to the second plunger position, the insert structure including a body through which the needle extends;

the housing having at least one slot or groove;

the body of the insert structure including a shaped portion 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.

15. The needle-inserting device of claim 14,

the housing having a flexible portion in the vicinity of the at least one slot or groove;

and

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

16. The needle-inserting device of claim 1, the device further comprising:

an insert structure arranged for movement within the internal chamber of the housing with movement of the plunger from the first plunger position to the second plunger position, the insert structure including a body through which the needle extends;

the insert structure having a fluid channel, the fluid channel operatively connectable to a reservoir when the insert structure moves with the plunger from the first plunger position to the second plunger position.

17. The needle-inserting device of claim 16, the device further comprising:

a hollow cannula having a hollow interior and arranged with the needle extending through the hollow interior;

wherein upon movement of the tab end, the plunger is free to move from the first plunger position to the second plunger position under the bias force imparted by the bias mechanism to move the hollow cannula to an insert position; and

wherein the fluid channel is in fluid communication with the hollow interior of the cannula upon the insert structure being moved with the plunger from the first plunger position to the second plunger position.

18. A medical device having the needle-inserting device of claim 1, the medical device further comprising:

a medical monitoring or treatment device configured to provide a monitoring or treatment operation on a user, the medical monitoring or treatment device operable with the needle of the needle-inserting device;

a medical device housing adapted to be secured to the user for supporting the medical monitoring or treatment device during operation of the medical monitoring or treatment device;

a magnifying material arranged on the medical device housing for increasing visibility of an injection site on skin of the user when piercing the skin of the user with the needle of the needle-inserting device.

19. The medical device of claim 18,

the medical device housing having an opening for inserting at least a portion of the needle of the needle-inserting device;

wherein the opening is in vertical alignment with the injection site.

20. The medical device of claim 18,

the medical device housing having an opening for inserting at least a portion of the needle of the needle-inserting device;

wherein the opening is disaligned with the injection site.

21. The medical device of claim 18,

wherein at least a portion of the magnifying area is located above the injection site.

22. The medical device of claim 18,

wherein the magnifying area is laterally offset to the injection site.

23. A medical device having the needle-inserting device of claim 1, the medical device further comprising:

a medical monitoring or treatment device configured to provide a monitoring or treatment operation on a user;

a base adapted to be secured to the user during operation of the medical monitoring or treatment device;

a structure adapted to be secured to the user during operation of the medical monitoring or treatment device, the structure connected to and supported by the base, the structure having a body, the structure and the base configured for relative movement there between; and

a cannula extending through the body of the structure during operation of the medical monitoring or treatment device, the cannula for inserting into the user with the needle of the needle-inserting device as the plunger of the needle-inserting device is moved under the bias force of the bias mechanism, to the second plunger position, the cannula for remaining in the user during operation of the medical monitoring or treatment device.

24. The medical device of claim 23, the structure arranged to be separate and apart from the base.

25. The medical device of claim 23, the structure operatively connected to the base.

26. The medical device of claim 23, the device further comprising:

a bias member provided between the base and the structure.

27. The medical device of claim 23,

the base having an interior chamber;

wherein the cannula is supported within the interior chamber of the base.

28. The medical device of claim 23,

the base having an interior chamber;

wherein the structure is supported within the interior chamber of the base.

29. The medical device of claim 23, the device further comprising:

an adhesive material provided on at least a portion of the structure and at least a portion of the base for securing the at least one of the base and the structure to the user, the adhesive material having a different adhesion strength on the structure than on the base.

30. The medical device of claim 23, the device further comprising:

an adhesive material provided on at least a first portion of the structure and at least a second portion of the structure for securing the structure to the user, the adhesive material having a different adhesion strength on the first portion than on the second portion.

31. The medical device of claim 23, the device further comprising:

an adhesive material provided on at least a first portion of the base and at least a second portion of the base for securing the base to the user, the adhesive material having a different adhesion strength on the first portion than on the second portion.

32. The medical device of claim 23, wherein the structure comprises a sensor for sensing a parameter of the user during operation of the medical monitoring or treatment device.

33. The medical device of claim 23, the device further comprising:

a sensor for sensing a parameter of the user during operation of the medical monitoring or treatment device, the sensor operatively connected to and supported by the structure.

34. The medical device of claim 23, the device further comprising:

a flexible connection connecting the base and the structure.

35. The medical device of claim 34,

at least one of the base, the structure, and the cannula placeable by the needle-inserting device;

the flexible connection adapted to release the needle-inserting device after placement of the at least one of the base, the structure, and the cannula.

36. The medical device of claim 34,

wherein the flexible connection comprises a living hinge connecting the base and the structure.

37. The medical device of claim 23, the device further comprising:

a fluid connection in fluid communication with the cannula and a reservoir containing fluidic media.

38. The medical device of claim 37, wherein the fluid connection comprises a flexible tubing.

39. The medical device of claim 23,

wherein the base has a base surface facing skin of the user during operation of the medical monitoring or treatment device;

wherein the base has an opening through the base surface; and

wherein the structure is supported at least partially within the opening.

40. The medical device of claim 39,

wherein the structure has an inserting surface facing skin of the user during operation of the medical monitoring or treatment device;

wherein an adhesive material provided on at least a portion of the base surface and at least a portion of the inserting surface for securing, the at least one of the base and the structure to the user, the adhesive material having a different adhesion strength on the structure than on the base.

41. A method of making a needle-inserting device, the method comprising:

providing a housing having a flexible portion, an internal chamber, a longitudinal dimension, and an internal surface having an angled, ramped or wedge-shaped portion;

arranging a plunger for movement within the internal chamber, in the direction of the longitudinal dimension of the housing, from a first plunger position to a second plunger position, the plunger having a tab end;

providing a 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; and

locating a needle connected to the plunger, for movement with the plunger;

arranging an insert structure within the internal chamber of the housing, for movement with movement of the plunger from the first plunger position to the second plunger position, the insert structure including a body through which the needle extends, and arranging at least one of the plunger or the body of the insert structure to engage the angled, ramped or wedge-shaped portion of the housing and outwardly flex the flexible portion of the housing upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position; and

configuring the tab end of the plunger to retain the plunger in the first plunger position, the tab end moveable relative to the housing such that upon movement of the tab end relative to the housing, the plunger is released from being retained in the first plunger position by the tab end and moves with the tab end, relative to the housing, in the direction of the longitudinal dimension of the housing from the first plunger position to the second plunger position under the bias force imparted by the bias mechanism to move the needle to an insert position and outwardly flex the flexible portion of the housing.

42. The needle-inserting device of claim 41, wherein the tab end is fixed to and held by the plunger prior to the tab end being moved to release the plunger, and remains fixed to the plunger as the plunger moves from a first plunger position to a second plunger position.

43. The method of claim 41, further comprising:

providing an opening in the housing that opens to the internal chamber, the opening having a width dimension smaller than a width dimension of the tab end;

wherein arranging the plunger further comprises arranging the plunger with the tab end located on one side of the opening of the housing prior to the tab end being moved to release the plunger; and

wherein configuring the tab end further comprises configuring the tab end to pass through the opening of the housing when the tab end is moved to release the plunger head from being retained in the first plunger position.

44. The method of claim 43, wherein configuring the tab end to pass through the opening of the housing when the tab end is moved to release the plunger head comprises configuring the tab end to compress to a size to fit and pass through the opening of the housing to release the plunger head.

45. The method of claim 43, wherein configuring the tab end to pass through the opening of the housing when the tab end is moved to release the plunger head comprises configuring the tab end to rotate or twist to fit and pass through the opening of the housing to release the plunger head.

46. A needle-inserting device, comprising:

a housing having a flexible portion, an internal chamber, a longitudinal dimension, and an internal surface having an angled, ramped or wedge-shaped portion;

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

a 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; and

a needle connected to the plunger for movement with the plunger; and

a tab integral with the plunger, the tab having a tab end configured to retain the plunger in the first plunger position, the tab end moveable relative to the housing and configured to be broken off the plunger;

an insert structure arranged for movement within the internal chamber of the housing with movement of the plunger from the first plunger position to the second plunger position, the insert structure including a body through which the needle extends, wherein at least one of the plunger or the body of the insert structure is arranged to engage the angled, ramped or wedge-shaped portion of the housing and outwardly flex the flexible portion of the housing upon the insert structure being moved as the plunger moves from the first plunger position to the second plunger position;

wherein upon movement of the tab end to break off the plunger, the plunger is free to move from the first plunger position to the second plunger position under the bias force imparted by the bias mechanism to move the needle to an insert position.

47. The needle-inserting device of claim 46, wherein the tab end is fixed to and held by the plunger prior to the tab end being moved to release the plunger, and wherein the tab end is fractured and broken off from the plunger when it is moved to release the plunger.