Insertion device systems and methods

• US 8,882,710 B2
• Filed: 01/27/2011
• Issued: 11/11/2014
• 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., Bikovsky, Rafael, Ibranyan, Arsen, Livingston, Adam J., McGee, Tom, Masterson, Steven
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US13/015,028
• Publication Number:
  US 20120029385A1
• Time in Patent Office: 1,384 Days
• Field of Search: 604/93.01, 604/64, 604/131, 604/135, 604/152, 604/180, 604/151
• US Class Current: 604/164.01
• 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 base adapted to be carried by a patient, and a housing attached to the base, the housing having a fluid connector arranged for movement relative to the base. A pair of interactive elements including a first interactive element may be supported on the base and a second interactive element supported on the housing at a location to be interactable with the first interactive element when the fluid connector is moved to a predetermined position. Circuitry may be configured to detect an interaction between the first interactive element and the second interactive element when the fluid connector is in the predetermined position, the circuitry configured to provide a signal or a change in state in response to detecting the interaction between the first interactive element and the second interactive element.

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 in a direction 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; and

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 engageable with the first carrier body; and

a drive mechanism arranged within the second device housing for providing a rotational force about an axis extending in the direction of movement of the first carrier body to cause the first carrier body 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.

2. The insertion system of claim 1, wherein the drive mechanism comprises a torsion spring member arranged to be wound and unwound about the axis, wherein upon winding, the torsion spring member imparts a rotational force in an unwinding direction.

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

a cam assembly operatively connected with the drive mechanism;

the cam assembly rotatable at least between a first orientation and a second orientation about the axis extending in the direction of movement of the first carrier body;

the cam assembly configured to move the second carrier body toward the advanced position as the cam assembly rotates from the second orientation to the first orientation;

the cam assembly configured to move the second carrier body toward the retracted position as the cam assembly rotates from the first orientation to the second orientation.

4. The insertion system of claim 3,

the cam assembly having a groove;

the second carrier body having a protrusion arranged for movement along the groove of the cam assembly, the cam assembly configured to guide the protrusion along the groove of the cam assembly as the cam assembly rotates between the second orientation and the first orientation to move the second carrier body between the retracted position and the advanced position.

5. The insertion system of claim 4, the cam assembly configured to guide the protrusion along the groove of the cam assembly as the cam assembly rotates between the first orientation and the second orientation to move the second carrier body between the advanced position and the retracted position.

6. The insertion system of claim 4, the cam assembly configured to guide the protrusion along the groove of the cam assembly as the cam assembly rotates between the second orientation and the first orientation to move the second carrier body between the retracted position and the advanced position.

7. The insertion system of claim 3, the drive mechanism having a first setting and a second setting, the drive mechanism biased toward the first setting in a case where the drive mechanism is in the second setting.

8. The insertion system of claim 7, the drive mechanism configured to rotate the cam assembly to the first orientation to move the second carrier body to the advanced position as the drive mechanism is returned to the first setting.

9. The insertion system of claim 7, the drive mechanism configured to rotate the cam assembly to the second orientation to move the second carrier body to the retracted position as the drive mechanism is set to the second setting.

10. The insertion system of claim 7, the insertion system further comprising:

an adjustment member for setting the drive mechanism to the second setting.

11. The insertion system of claim 10,

the adjustment member configured to rotate the cam assembly to the second orientation;

and

the cam assembly operatively connected to the drive mechanism such that rotation of the cam assembly to the second orientation sets the drive mechanism to the second setting.

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

a locking mechanism adapted to operatively engage and disengage from the cam assembly, the locking mechanism configured to substantially prevent rotation of the cam assembly in a case where the locking mechanism is engaged with the cam assembly.

13. The insertion system of claim 12, the locking mechanism comprising a trigger member, at least one of the trigger member and the cam assembly having a tab for engaging and disengaging from an aperture in the other of the at least one of the trigger and the cam assembly, the locking mechanism configured to substantially prevent rotation of the cam assembly in a case where the tab is engaged with the aperture.

14. The insertion system of claim 1, the drive mechanism 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 positioned to insert at least a portion of the piercing member through skin of the patient.

15. 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.

16. 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 retracted position to the advanced position.

17. 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 retracted position to the advanced position.

18. 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.

19. 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.

20. The insertion system of claim 19,

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.

21. The insertion system of claim 20, 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.

22. The insertion system of claim 20,

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 medic to flow from the reservoir to the hollow interior of the cannula.

24. 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.

25. The insertion system of claim 24, 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.

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

27. The insertion system of claim 26, wherein the insertion system is completely removable from the selected one of the at least two different types of piercing members.

28. The insertion system of claim 24, the piercing member supported by the first carrier body is one of the at least two different types of piercing members.

29. The insertion system of claim 24, wherein the selected one of the at least two different types of piercing members is an insertion needle of an insertion set.

30. The insertion system of claim 24, 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.

31. The insertion system of claim 30, 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.

32. The insertion system of claim 24, 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.

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

34. The insertion system of claim 33, at least one of the first carrier body and the second carrier body having a magnet, and the other of the at least one of the first carrier body and the second carrier body having an attractive element for interacting with the magnet to connect the first carrier body and the second carrier body.

35. The insertion system of claim 33, wherein the attractive element comprises one of a ferrous material and a magnet.

36. The insertion system of claim 1,

the first device housing having a section for supporting a portion of the first carrier body and for preventing the first carrier body from moving to the advanced position, the section moveable relative to the first carrier body;

the second device housing configured to cause movement of the section of the first device housing to provide sufficient clearance to allow the first carrier body to move to the advanced position in a case where the first carrier body is moved by the second carrier body.

37. The insertion system of claim 36, the second device housing having a portion for operatively engaging the section of the first device housing to cause movement of the section of the first device housing in a case where the second device housing is operatively connected with the first device housing and the second device housing is rotated relative to the first device housing.

38. The insertion system of claim 1, wherein the first carrier body moves along the axis of rotational force, from the retracted position to the advanced position.

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

a cam assembly operatively connected with the drive mechanism to rotate about the axis in response to the rotational force provided by the drive mechanism,

wherein the second carrier body is operatively engaged with the cam assembly to move between the refracted position and the advanced position in response to rotation of the cam assembly about the axis.

40. The insertion system of claim 39, wherein movement of the second carrier body between the retracted position and the advanced position causes the first carrier body to move between the retracted position and the advanced position when the second carrier body is engaged with the first carrier body.

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

a rotatable body operatively connected with the drive mechanism to rotate in response to the rotational force provided by the drive mechanism, the rotatable body having a hollow interior portion,

wherein the second carrier body extends at least partially into the hollow interior portion of the rotatable body and operatively engages with the rotatable body to move between the retracted position and the advanced position in response to rotation of the rotatable body.

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

42. A method of manufacturing 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, configuring the first device housing comprising;

arranging a first carrier body for movement in a direction 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; and

configuring a second device housing to be operatively engaged with and disengaged from the first device housing, configuring 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 retracted position and an advanced position, the second carrier body operatively engageable with the first carrier body; and

arranging a drive mechanism within the second device housing for providing a rotational force about an axis extending in the direction of movement of the first carrier body to cause the first carrier body 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.

43. An insertion detection system, the system comprising:

a base adapted to be carried by a patient;

a housing attached to the base, the housing containing a carrier body that has a fluid connector, the carrier body arranged for movement relative to the base at least between a retracted position and an advanced position, the carrier body for supporting the fluid connector in a position orientated for insertion of at least a portion of the fluid connector through skin of the patient upon movement of the carrier body from the retracted position to the advanced position;

a pair of interactive elements including a first interactive element supported on the base and a second interactive element supported on the carrier body at a location to be interactable with the first interactive element when the carrier body is moved from one of the retracted position and advanced position to the other of the retracted position and advanced position; and

circuitry configured to detect an interaction between the first interactive element and the second interactive element when the carrier body is moved from one of the retracted position and advanced position to the other of the retracted position and advanced position, the circuitry configured to provide a signal or a change in state in response to detecting the interaction between the first interactive element and the second interactive element.

44. The system of claim 43, wherein the housing is configured to be operatively engaged to an actuation device for selectively moving the carrier body from the refracted position toward the advanced position to insert at least a portion of the fluid connector through skin of the patient.

45. The system of claim 43, wherein when the carrier body is in the advanced position, the fluid connector is inserted through the skin of the patient.

46. The system of claim 45, wherein when the carrier body is in the advanced position, the fluid connector is inserted in the skin of the patient a defined depth.

47. The system of claim 43, wherein when the carrier body is in the advanced position, the first interactive element and the second interactive element are sufficiently proximate to each other to interact with each other.

48. The system of claim 43, wherein the fluid connector is in a predetermined position when the first interactive element and the second interactive element are sufficiently proximate to each other to interact with each other.

49. The system of claim 48, wherein the first interactive element and the second interactive element are sufficiently proximate to each other in a case where the first interactive element and the second interactive element contact each other.

50. The system of claim 43, wherein when the carrier body is in the advanced position, the fluid connector is in fluid communication with a fluid path of the base.

51. The system of claim 43, wherein the fluid connector comprises at least one of a cannula and a needle.

52. The system of claim 43, the system further comprising:

a user-perceptible indicator operatively connected to the circuitry, the user-perceptible indicator for providing a user-perceptible indication in response to the signal or the change in state by the circuitry.

53. The system of claim 52, wherein the user-perceptible indication comprises at least one of an audible indication, a visual indication, and a tactile indication.

54. The system of claim 43, the first interactive element and the second interactive element configured to be electronically interactable with each other.

55. The system of claim 43,

one of the base and the housing supporting a reservoir having an interior volume for containing fluidic media and a plunger head moveable within the interior volume of the reservoir along an axial direction of the reservoir;

the system further comprising;

a drive device supported by the other of the base and the housing relative to the one of the base and the housing supporting the reservoir;

control electronics operatively connected to the circuitry for controlling the drive device to drive fluid from the reservoir based upon the signal or the state provided by the circuitry.

56. The system of claim 55, the control electronics configured to inhibit operation of the drive device unless a signal or a state provided by the circuitry corresponds to the signal or the state provided by the circuitry when detecting the interaction between the first interactive element and the second interactive element.

57. The system of claim 55, the control electronics configured to change from a first power state to a second power state in response to detecting the interaction between the first interactive element and the second interactive element.

58. The system of claim 55, wherein in the fluid connector comprises the reservoir.

59. The system of claim 43,

wherein the first interactive element comprises a detectable feature;

wherein the second interactive element comprises a sensor configured to sense the detectable feature when the fluid connector is moved to the predetermined position; and

wherein the circuitry is configured to provide the signal or the change in state in a case where the detectable feature is detected by the sensor.

60. The system of claim 59,

wherein the sensor comprises at least one magnetic sensor;

and

wherein the detectable feature comprises a magnetic material.

61. The system of claim 43,

wherein one of the first interactive element and the second interactive element has a capacitance that is measurable;

wherein the other of the one of the first interactive element and the second interactive element is configured to affect the capacitance when the fluid connector is in the predetermined position;

the circuitry configured to provide the signal or the change in state when the capacitance is affected by the other of the one of the first interactive element and the second interactive element.

62. The system of claim 43,

wherein one of the first interactive element and the second interactive element has an inductance that is measurable;

wherein the other of the one of the first interactive element and the second interactive element is configured to affect the inductance when the fluid connector is in the predetermined position;

the circuitry configured to provide the signal or the change in state when the inductance is affected by the other of the one of the first interactive element and the second interactive element.

63. The system of claim 43, wherein the housing is configured to be operatively engaged with and disengaged from the base.

64. The system of claim 43, wherein the housing is integral with the base.

65. The system of claim 43,

wherein one of the first interactive element and the second interactive element includes data or information;

and

wherein the other of the one of the first interactive element and the second interactive element is configured to access the data or information of the one of the first interactive element and the second interactive element when the first element and the second element interact.

66. The system of claim 65, wherein the circuitry is configured to provide a signal or a change in state based on the data or information accessed by the other of the one of the first interactive element and the second interactive element.

67. The system of claim 43,

wherein the fluid connector includes data or information;

and

wherein one of the first interactive element and the second interactive element is configured to access the data or information when the first element and the second element interact.

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

adapting a base to be carried by a patient;

arranging a housing on the base, the housing containing a carrier body that has a fluid connector, the carrier body arranged for movement relative to the base at least between a retracted position and an advanced position, the carrier body for supporting the fluid connector in a position orientated for insertion of at least a portion of the fluid connector through skin of the patient upon movement of the carrier body from the retracted position to the advanced position;

providing a pair of interactive elements including a first interactive element supported on the base and a second interactive element supported on the carrier body at a location to be interactable with the first interactive element when the fluid connector is moved to a predetermined position; and

configuring circuitry to detect an interaction between the first interactive element and the second interactive element when the carrier body is moved from one of the retracted position and advanced position to the other of the retracted position and advanced position, the circuitry configured to provide a signal or a change in state in response to detecting the interaction between the first interactive element and the second interactive element.

69. An insertion detection system, the system comprising:

a base adapted to be carried by a patient;

a housing attached to the base;

a carrier body arranged for movement within at least a portion of the housing at least between a retracted position and an advanced position, the carrier body for supporting a piercing member in a position orientated for insertion through skin of the patient upon movement of the carrier body from the retracted position to the advanced position;

a pair of interactive elements including a first interactive element supported on the base and a second interactive element supported on the carrier body at a location to be interactable with the first interactive element when the piercing member is positioned in a predetermined position; and

circuitry configured to detect an interaction between the first interactive element and the second interactive element when the carrier body is moved from one of the retracted position and advanced position to the other of the retracted position and advanced position, the circuitry configured to provide a signal or a change in state in response to detecting an interaction between the first interactive element and the second interactive element.