Insertion device systems and methods

• US 8,900,190 B2
• Filed: 09/02/2009
• Issued: 12/02/2014
• Est. Priority Date: 09/02/2009
• 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): FLICK, JASON E
• Application Number:
  US12/553,038
• Publication Number:
  US 20110054399A1
• Time in Patent Office: 1,917 Days
• Field of Search: 600/345, 600/365, 604/891.1, 604/93.01, 604/131
• 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 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• 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 5/1456 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: Y10T 29/49826 Assembling or joining

Abstract

A first device housing may be configured to be operatively engaged with and disengaged from a base carried by a user and may include a first carrier body arranged for movement at least between a refracted position and an advanced position. The first carrier body may support a piercing member for insertion through skin of the patient. A second device housing may be configured to be operatively engaged with and disengaged from the first device housing and may include a second carrier body operatively connectable with the first carrier body and arranged for movement at least between a retracted position and an advanced position. A driver in the second device housing may be arranged to move the first carrier body toward the advanced position to insert at least a portion of the piercing member through skin of the patient.

Claims

1. An insertion system, the insertion system comprising:

a base adapted to be carried by a patient;

a first device housing configured to be operatively engaged with and disengaged from the base, the first device housing comprising;

a first carrier body arranged for movement within at least a portion of the first device housing at least between a refracted position and an advanced position, the first carrier body for supporting a piercing member in a position orientated for insertion through skin of the patient upon movement of the first carrier body from the retracted position to the advanced position, the first device housing configured to be automatically disengaged and removably released from the base upon the first carrier body being moved to the advanced position;

a second device housing configured to be operatively engaged with and disengaged from the first device housing, the second device housing comprising;

a second carrier body arranged for movement within at least a portion of the second device housing at least between a retracted position and an advanced position, the second carrier body operatively connectable with the first carrier body; and

a driver arranged within the second device housing to move the first carrier body from the retracted position toward the advanced position to insert at least a portion of the piercing member through skin of the patient;

wherein the first device housing is configured to be removably released from the base in a direction that is different from a direction of movement of the first carrier body from the retracted position to the advanced position.

2. The insertion system of claim 1, the driver arranged within the second device housing to move the second carrier body from the retracted position toward the advanced position to move the first carrier body from the retracted position toward the advanced position to insert at least a portion of the piercing member through skin of the patient.

3. The insertion system of claim 1, the insertion system further comprising:

a locking mechanism adapted to operatively engage at least one of the driver and the second carrier body, and to substantially prevent premature release of the carrier body before securing the insertion system in position against the skin of the patient.

4. The insertion system of claim 1, the first carrier body configured to operatively engage the base when the first carrier body is moved to the advanced position.

5. The insertion system of claim 4, the first carrier body configured to disengage the first device housing from the base upon the first carrier body being moved to the advanced position.

6. The insertion system of claim 5,

one of the base and the first device housing having an aperture, the other of the base and the first device housing having an arm for engaging the aperture to operatively engage the first device housing to the base;

and

the first carrier body having at least one protrusion for disengaging the arm from the aperture upon the first carrier body being moved to the advanced position.

7. The insertion system of claim 1, one of the base and the first device housing having an aperture, the other of the base and the first device housing having an arm for engaging the aperture to operatively engage the first device housing to the base.

8. The insertion system of claim 1, wherein the first carrier body comprises a plunger configured to support the piercing member, and to insert the piercing member in the skin of the user-patient upon movement of the first carrier body from the refracted position to the advanced position.

9. The insertion system of claim 1, wherein a distance traveled by the first carrier body relative to the first device housing from the retracted position to the advanced position is equal to at least a distance traveled by the second carrier body relative to the second device housing from the refracted position to the advanced position.

10. The insertion system of claim 1, wherein a distance traveled by the first carrier body relative to the first device housing from the retracted position to the advanced position is equal to at least a distance required to insert the piercing member into the skin of the patient.

11. The insertion system of claim 1, the first carrier body comprising a plunger and a collar body operatively connected to the plunger, the piercing member supported by at least one of the plunger and the collar body in a position orientated for insertion through the skin of the patient upon movement of the first carrier body from the retracted position to the advanced position.

12. The insertion system of claim 11,

wherein the piercing member comprises a cannula supported by the collar body and a needle supported by the plunger;

the needle disposed at least partially through the cannula;

the cannula and the needle supported in a position orientated for insertion through the skin of the patient upon movement of the first carrier body from the retracted position to the advanced position.

13. The insertion system of claim 12, the plunger and the needle removable from the collar body, the cannula and the collar body adapted for reuse with another collar body and cannula.

14. The insertion system of claim 12,

the collar body having a fluid channel in fluid communication with a hollow interior of the cannula;

the fluid channel for operatively connecting to a reservoir for containing fluidic media when the first carrier body is in the advanced position to allow fluidic media to flow from the reservoir to the hollow interior of the cannula.

15. The insertion system of claim 12, the insertion system further comprising:

a compliant material arranged within the first carrier body to support the piercing member, the compliant material for allowing articulation of the piercing member relative to the first carrier body in a case where at least a portion of the piercing member is in the skin of the patient and the piercing member is moved relative to the housing.

16. The insertion system of claim 15, wherein the piercing member comprises a needle.

17. The insertion system of claim 1, wherein the driver comprises a bias member arranged within the second device housing, the bias member for urging the second carrier body toward the advanced position.

18. The insertion system of claim 17, the insertion system further comprising:

a second driver arranged within the second device housing to move the first carrier body away from the advanced position to a third position.

19. The insertion system of claim 18, wherein the second driver comprises a bias member arranged within the second device housing, the bias member for urging the second carrier body toward the third position.

20. The insertion system of claim 19, the insertion system further comprising:

a trigger for releasably retaining the second carrier body in the advanced position, the trigger configured to be operable to release the second carrier body to allow the second carrier body to move to the third position.

21. The insertion system of claim 17, the insertion system further comprising:

a trigger for releasably retaining the second carrier body in the refracted position, the trigger configured to be operable to release the second carrier body to allow the second carrier body to move to the advanced position.

22. The insertion system of claim 1, the second carrier body configured to operatively connect with at least two different types of piercing members, the second carrier body configured to insert at least a portion of a selected one of the at least two different types of piercing members in a case where the selected one of the at least two different types of piercing members is operatively connected to the second carrier body and the second carrier body is moved to the advanced position.

23. The insertion system of claim 22, the second carrier body configured to be removable from the selected one of the at least two different types of piercing members and adapted for reuse with another one of the at least two different types of piercing members.

24. The insertion system of claim 22, wherein the insertion system is removable from the selected one of the at least two different types of piercing members.

25. The insertion system of claim 24, wherein the insertion system is completely removable from the selected one of the at least two different types of piercing members.

26. The insertion system of claim 22, the piercing member supported by the first carrier body is one of the at least two different types of piercing members.

27. The insertion system of claim 22, wherein the selected one of the at least two different types of piercing members is an insertion needle of an insertion set.

28. The insertion system of claim 22, wherein the selected one of the at least two different types of piercing members is a lancet for obtaining a fluid sample from the patient.

29. The insertion system of claim 28, the insertion system further comprising:

a guard configured to be removably attachable to the second device housing, the guard having an aperture for allowing the lancet to extend through in a case where the lancet is operatively connected to the second carrier body and the second carrier body is moved to the advanced position.

30. The insertion system of claim 22, wherein a distance traveled by the first carrier body relative to the first device housing from the retracted position to the advanced position is equal to at least a distance required to insert the selected one of the at least two different types of piercing members in the skin of the patient that is at least equal to an implantable length of the selected one of the at least two different types of piercing members.

32. The insertion system of claim 1 further comprising:

at least one movable member having a first position and a second position,

the at least one movable member moving into the first position when the first carrier body and the second carrier body are moved into the retracted position and securing the first device housing into place, and

the at least one movable member moving in the second position when the first carrier body and the second carrier body are moved into the advanced position and automatically disengaging the first device housing from the base.

34. The insertion system of claim 1 wherein the base comprises a retaining surface and the insertion system further comprises:

at least one flexible arm having an engaging surface that moves between a first position and a second position,

the at least one flexible arm moving into the first position when the first carrier body is moved into the retracted position and securing the first carrier body into place when the engaging surface engages the retaining surface, and

the at least one movable member moving in the second position when the first carrier body is moved into the advanced position and automatically disengaging the first carrier body by releasing the engaging surface from the retaining surface.

35. The insertion system of claim 1, wherein the first device housing is configured to be removed away from the base after the first device housing is disengaged and removably released from the base.

37. The insertion system of claim 1, the first device housing configured to receive at least a portion of the second device housing to operatively engage the second device housing.

38. The insertion system of claim 6, wherein the at least one protrusion disengages the arm from the aperture by moving the arm in a direction transverse from the direction of movement of the first carrier body from the retracted position to the advanced position.

39. The insertion system of claim 7,

the first carrier body having at least one protrusion for disengaging the arm from the aperture upon the first carrier body being moved to the advanced position;

wherein the at least one protrusion disengages the arm from the aperture by moving the arm in a direction transverse from the direction of movement of the first carrier body from the retracted position to the advanced position.

40. The insertion system of claim 1,

the first device housing having a movable portion to selectively engage and disengage the first device housing and the base;

wherein the movable portion is configured to move in a first direction to engage the first device housing to the base and to move in a second direction opposite the first direction to disengage the first device housing from the base; and

wherein the second direction is transverse the direction of movement of the first carrier body from the retracted position to the advanced position.

41. The insertion system of claim 1, wherein the first device housing and the second device housing are configured for threaded engagement with each other.

31. A method of making an insertion system, the method comprising:

adapting a base to be carried by a patient;

configuring a first device housing to be operatively engaged with and disengaged from the base;

arranging a first carrier body for movement within at least a portion of the first device housing at least between a retracted position and an advanced position, the first carrier body for supporting a piercing member in a position orientated for insertion through skin of the patient upon movement of the first carrier body from the retracted position to the advanced position, the first device housing configured to be automatically disengaged and removably released from the base upon the first carrier body being moved to the advanced position;

configuring a second device housing to be operatively engaged with and disengaged from the first device housing, the second device housing comprising;

arranging a second carrier body for movement within at least a portion of the second device housing at least between a refracted position and an advanced position, the second carrier body operatively connectable with the first carrier body; and

arranging a driver within the second device housing to move the first carrier body from the retracted position toward the advanced position to insert at last a portion of the piercing member through skin of the patient;

wherein the first device housing is configured to be removably released from the base in a direction that is different from a direction of movement of the first carrier body from the retracted position to the advanced position.

33. The method of claim 31 further comprising:

moving at least one movable member into a first position when the first carrier body and the second carrier body are moved into the refracted position and securing the first device housing into place; and

moving the at least one movable member into a second position when the first carrier body and the second carrier body are moved into the advanced position and automatically disengaging the first device housing from the base.

36. The method of claim 31, further comprising removing the first device housing away from the base after the first device housing is disengaged and removably released from the base.