Insertion device systems and methods

• US 8,932,256 B2
• Filed: 01/27/2011
• Issued: 01/13/2015
• 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., Bikovsky, Rafael, Ibranyan, Arsen, Livingston, Adam J., McGee, Tom, Masterson, Steven
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US13/015,051
• Publication Number:
  US 20110178461A1
• Time in Patent Office: 1,447 Days
• Field of Search: 604/93.01, 604/64, 604131-158, 60416401-17003, 604272-274, 604523-532, 604/890.1
• US Class Current: 604/156
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An insertion device may include a device housing configured to be operatively engaged with and disengaged from a base, and engageable with an actuation device, the device housing having a carrier body supporting a piercing member. The carrier body moveable by a carrier body of the actuation device at least between a retracted position and an advanced position. The device housing having a section for supporting a portion of the carrier body of the device housing, the section moveable relative to the carrier body of the device housing to provide sufficient clearance to allow the carrier body of the device housing to be moved by the carrier body of the actuation device.

Claims

1. An insertion system, the insertion system comprising:

a device housing configured to be operatively engaged with and disengaged from a base adapted to be carried by a patient, the device housing configured to be engaged with and disengaged from an actuation device; and

an insert structure arranged for movement within at least a portion of the device housing at least from a retracted position toward an advanced position, the insert structure holding a piercing member in a position orientated for insertion through skin of the patient upon movement of the insert structure from the retracted position to the advanced position, the insert structure operatively engaged with a moveable carrier body of the actuation device to receive a force from the moveable carrier body of the actuation device to move the insert structure at least from a retracted position to the advanced position when the device housing is engaged with the actuation device;

wherein the device housing has a section for engaging a portion of the insert structure for preventing the insert structure from moving to the advanced position when the device housing is disengaged from the actuation device, the section moveable relative to the insert structure to provide sufficient clearance to allow the insert structure to move to the advanced position when the device housing is engaged with the actuation device.

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

the actuation device, the carrier body of the actuation device arranged for movement within at least a portion of the actuation device at least between a retracted position and an advanced position.

3. The insertion system of claim 2, the system further comprising:

a drive mechanism arranged within the actuation device to move the insert structure from the retracted position toward the advanced position to insert at least a portion of the piercing member through skin of the patient, when the device housing is engaged with the actuation device.

4. The insertion system of claim 3, the drive mechanism configured to provide a rotational force to cause the insert structure to move from the retracted position toward the advanced position to insert at least a portion of the piercing member through skin of the patient, when the device housing is engaged with the actuation device.

5. The insertion system of claim 2, the actuation device configured to cause movement of the section of the device housing to provide sufficient clearance to allow the insert structure to move to the advanced position in a case where the device housing is engaged with the actuation device and the insert structure is moved by the carrier body of the actuation device.

6. The insertion system of claim 1, at least one of the device housing and the actuation device having a magnet, and the other of the at least one of the device housing and the actuation device having an attractive element for interacting with the magnet to connect the device housing and the actuation device.

7. The insertion system of claim 6, at least one of the insert structure and the carrier body of the actuation device having a magnet, and the other of the at least one of the insert structure and the carrier body of the actuation device having an attractive element for interacting with the magnet to connect the insert structure and the carrier body of the actuation device.

8. The insertion system of claim 6, wherein the attractive element comprises one of a ferrous material and a magnet.

9. The insertion system of claim 1, the device housing further comprising:

an engagement member engageable with and disengageable from the base to operatively engage and disengage the device housing and the base;

wherein at least one of the base and the engagement member configured such that the engagement member is prevented from engaging the base in a case where the engagement member has been disengaged from the base unless a second force having a magnitude equal to or greater than the first force is applied to the engagement member.

10. The insertion system of claim 1, wherein the piercing member comprises a needle.

11. The insertion system of claim 1, wherein the insert structure 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 insert structure from the retracted position to the advanced position.

12. The insertion system of claim 1, wherein a distance traveled by the insert structure relative to the 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.

13. The insertion system of claim 1, the insert structure 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 insert structure from the retracted position to the advanced position.

14. The insertion system of claim 13,

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 insert structure from the retracted position to the advanced position.

15. The insertion system of claim 14, 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.

16. The insertion system of claim 14,

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 insert structure is in the advanced position to allow fluidic medic to flow from the reservoir to the hollow interior of the cannula.

17. The insertion system of claim 1, wherein the section for engaging a portion of the insert structure comprises at least one moveable member that moves from a first position at which the at least one moveable member abuts the insert structure to inhibit movement of the insert structure to the advanced position, to a second position at which the at least one moveable member provides sufficient clearance to allow the insert structure to move to the advanced position.

18. The insertion system of claim 17, wherein the at least one moveable member is moved from the first position to the second position by movement of the actuation device into engagement with the device housing.

19. The insertion system of claim 17, wherein the at least one moveable member comprises at least one flexible finger that flexes between the first position and the second position.

20. The insertion system of claim 1, wherein the section for engaging a portion of the insert structure comprises a plurality of moveable fingers that move from a first position at which the plurality of fingers abut the insert structure to inhibit movement of the insert structure to the advanced position, to a second position at which the plurality of fingers spread apart to provide sufficient clearance to allow the insert structure to move to the advanced position.

21. A method of manufacturing an insertion system, the method comprising:

configuring a device housing to be operatively engaged with and disengaged from a base adapted to be carried by a patient, the device housing configured to be engaged with and disengaged from an actuation device;

arranging an insert structure for movement within at least a portion of the device housing at least from a retracted position toward an advanced position, the insert structure holding a piercing member in a position orientated for insertion through skin of the patient upon movement of the insert structure from the retracted position to the advanced position, the insert structure operatively engaged with a moveable carrier body of the actuation device to receive a force from the moveable carrier body of the actuation device to move the insert structure at least from a retracted position to the advanced position when the device housing is engaged with the actuation device; and

arranging a section of the device housing to engage a portion of the insert structure for preventing the insert structure from moving to the advanced position when the device housing is disengaged from the actuation device, the section moveable relative to the insert structure to provide sufficient clearance to allow the insert structure to move to the advanced position in a case where the device housing is engaged with the actuation device.

22. An insertion system, the insertion system comprising:

a base adapted to be carried by a patient;

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

an insert structure arranged for movement within at least a portion of the device housing at least between a retracted position and an advanced position, the insert structure for supporting a piercing member in a position orientated for insertion through skin of the patient upon movement of the insert structure from the retracted position to the advanced position, the insert structure operatively engageable with a moveable carrier body of the actuation device, the carrier body of the actuation device for moving the insert structure at least between the retracted position and the advanced position; and

an engagement member movable relative to the device housing between engagement and disengagement positions to operatively engage and disengage the device housing with the base, the engagement member configured to engage the base in a case where a first force of at least a particular magnitude is applied to the engagement member;

wherein at least one of the base and the engagement member includes an abutment that inhibits the engagement member from being moved to the engagement position for engaging the base in a case where the engagement member has been moved from the engagement position to the disengagement position and disengaged from the base.

23. The insertion system of claim 22,

the engagement member engageable with and disengageable from an aperture of the base to operatively engage and disengage the device housing and the base;

wherein the abutment is arranged to inhibit the engagement member from engaging the aperture of the base in a case where the engagement member has been disengaged from the based.

24. The insertion system of claim 22, the engagement member engageable with and disengageable from an aperture of the base to operatively engage and disengage the device housing and the base.

25. The insertion system of claim 22, wherein the engagement member is a lever.

26. The insertion system of claim 22, wherein the piercing member comprises a needle.

27. The insertion system of claim 22, wherein the carrier body of the device housing 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 insert structure from the retracted position to the advanced position.

28. The insertion system of claim 22, wherein a distance traveled by the insert structure relative to the 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.

29. The insertion system of claim 22, the insert structure 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 insert structure from the retracted position to the advanced position.

30. The insertion system of claim 29,

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 insert structure from the retracted position to the advanced position.

31. The insertion system of claim 30, 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.

32. The insertion system of claim 30,

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 insert structure is in the advanced position to allow fluidic medic to flow from the reservoir to the hollow interior of the cannula.

33. The insertion system of claim 22, wherein the engagement member comprises a pivotal arm supported for pivotal motion between the engagement position and the disengagement position, and wherein the abutment is arranged to inhibit pivotal motion of the pivotal arm to the engagement position after the pivotal arm has pivoted from the engagement position to the disengagement position.

34. The insertion system of claim 33, wherein the engagement member comprises a pivotal arm supported on the device housing for pivotal motion relative to the device housing between the engagement position and the disengagement position.

35. A method of manufacturing an insertion system, the method comprising:

adapting a base to be carried by a patient;

configuring a device housing to be operatively engaged with and disengaged from the base, the device housing engageable with an actuation device, configuring the device housing comprising;

arranging a insert structure for movement within at least a portion of the device housing at least between a retracted position and an advanced position, the insert structure for supporting a piercing member in a position orientated for insertion through skin of the patient upon movement of the insert structure from the retracted position to the advanced position, the carrier body insert structure operatively engageable with a moveable carrier body of the actuation device, the carrier body of the actuation device for moving the insert structure at least between the retracted position and the advanced position;

providing an engagement member movable relative to the device housing between engagement and disengagement positions to operatively engage and disengage the device housing with the base, the engagement member configured to engage the base in a case where a first force of at least a particular magnitude is applied to the engagement member; and

configuring at least one of the base and the engagement member includes an abutment that inhibits the engagement member from being moved to the engagement position for engaging the base in a case where the engagement member has been moved from the engagement position to the disengagement position and disengaged from the base unless a second force having a magnitude equal to or greater than the first force is applied to the engagement member.