Medical Device with Cannula Inserter

• US 20090012472A1
• Filed: 09/22/2005
• Published: 01/08/2009
• Est. Priority Date: 09/22/2004
• Status: Abandoned Application

• Current Assignee: Dyna-Air Co., Ltd., Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Ahm, Thorkild, Teisen-Simony, Claude, Rorvig, Simon
• Application Number:
  US11/662,905
• Publication Number:
  US 20090012472A1
• Time in Patent Office: Days
• US Class Current: 604/138
• 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 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A medical device is provided comprising a cannula (771, 861) having a distal end portion adapted to be arranged through the skin of the subject and having a distal opening, and a needle (761, 861) arranged coaxially with and being axially moveable relative to the cannula, the needle comprising a pointed distal end, wherein the device is adapted for advancing the cannula with the distal end of the needle projecting there from through the dermis of the subject, and further advancing the cannula into the subcutis of the subject with the distal end of the cannula projecting relative to the needle.

Claims

1. A medical device (700, 800), comprising:

a housing adapted for application towards the skin of a subject,

a cannula (771, 871) having a distal end portion adapted to be arranged through the skin of the subject and having a distal opening, and

a needle (761, 861) arranged coaxially with and being axially moveable relative to the cannula, the needle comprising a distal end adapted to penetrate the skin of the subject,

wherein the medical device is transformable between;

a first state in which the cannula and the needle are retracted within the housing,

a second state in which the cannula and the needle are extended relative to the lower surface with the distal end of the needle projecting relative to the distal opening of the cannula thereby allowing the cannula to be introduced through the skin of the subject,

a third state in which the distal end of the needle is positioned short of the distal end portion of the cannula, the cannula not being fully extended relative to the housing, and

a fourth state in which the cannula is fully extended relative to the housing.

2. A medical device as in claim 1, wherein the needle (761) is arranged within the cannula (771).

3. A medical device as in claim 2, wherein in the fourth state the distal end of the needle is positioned within the cannula short of the distal opening.

4. A medical device as in any of claim 1, the medical device being transformable to a fifth state in which the needle is retracted from the portion of the cannula extending from the housing.

5. A medical device as in claim 3, comprising an inserter assembly (740) for moving the cannula and the insertion needle between the different states, the inserter assembly comprising:

the cannula (771),

an inserter (750) for moving the cannula,

the needle (761), and

a needle holder (760) attached to the needle,

wherein the inserter assembly has;

an initial state in which the needle holder is locked to the inserter in an initial position with the distal end of the needle projecting from the distal opening of the cannula, and

an intermediate state in which the needle holder is locked to the inserter in an intermediate position with the distal end of the needle positioned within the cannula short of the distal opening.

6. A medical device as in claim 5, wherein:

the inserter assembly is transformable from the first to the second state with the inserter assembly in its initial state,

the inserter assembly is transformable from the second to the third state when the inserter is transformed from its initial to its intermediate state, and

the inserter assembly is transformable from the third to the fourth state with the inserter assembly in its intermediate state.

7. A medical device as in claim 5, wherein the inserter assembly has a retracted state in which the needle is retracted from the portion of the cannula extending from the housing.

8. A medical device as in claim 6, wherein the inserter assembly is transformable from the fourth to the fifth state when the inserter is transformed from its intermediate to its retracted state.

9. A medical device as in claim 5, wherein the cannula in the fully extended position is adapted to be locked in place relative to the housing.

10. A medical device as in claim 5, wherein the inserter assembly further comprises a cannula holder (770) attached to the cannula, the cannula holder being moved by the inserter from a retracted to a fully extended position, the cannula holder and the housing being adapted for locking the cannula in its extended position.

11. A medical device as in claim 5, comprising a user-releaseable actuator (751) for actuating the inserter assembly from the first to the fourth state.

12. A medical device as in claim 11, wherein the actuator comprises a spring urging the inserter from an initial position to an extended position corresponding to the first respectively the fourth state.

13. A medical device as in claim 11, comprising a retractor (780) for retracting the needle from its fully extended to a retracted position.

14. A medical device as in claim 10, comprising first (723) and second (733) housing portions coupled to each other, wherein:

the cannula in its extended position is locked to the first housing portion,

the needle is retracted into the second housing portion, and

the second housing portion can be detached from the first housing portion, the needle being arranged there within.

15. A medical device as in claim 14, further comprising a flexible sheet member (721) with a lower surface adapted to be arranged on a skin surface of a subject, and an upper surface to which the first housing portion is arranged.

16. An assembly comprising a medical device as in claim 15 and a delivery device (5) adapted to be coupled to the first housing portion, the delivery device comprising a reservoir (760) adapted to contain a fluid drug, and an expelling assembly (300) adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the cannula when the delivery device has been coupled to the first housing portion after the cannula has been inserted and the second housing portion removed.

17. A medical device as in claim 1, wherein the needle is hollow and comprises a proximal end, the distal end of the needle being in sealed fluid communication with the interior of the cannula with the needle in its retracted position, whereby a fluid communication is provided between the proximal end of the needle and the cannula.

18. An assembly comprising a medical device as in claim 17 and a delivery device adapted to be coupled to the first housing portion, the delivery device comprising a reservoir adapted to contain a fluid drug, and an expelling assembly adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the hollow needle and the cannula when the delivery device has been coupled to the first housing portion after the cannula has been inserted and the needle retracted.

19. A medical device (800) as in claim 1, wherein the needle (861) is hollow and arranged outside the cannula (871).

20. A medical device as in claim 19, wherein the needle is fully extended corresponding to the third state.

21. A medical device as in claim 19, comprising an inserter assembly (840) for moving the cannula and the insertion needle between the different states, the inserter assembly comprising:

the cannula (871),

the needle (861),

an inserter (850) attached to the needle,

a cannula holder (870) attached to the cannula and adapted for moving the cannula relative to the inserter and thereby the needle,

wherein the inserter assembly has;

an initial state in which the cannula is positioned within the needle and with the distal end of the needle projecting relative to the distal opening of the cannula,

an intermediate state in which the cannula holder has been moved to extend the cannula from the needle, and

wherein the inserter assembly has a retracted and an extended position.

22. A medical device as in claim 21, wherein:

the inserter assembly is transformable from the first to the second state when the inserter assembly is moved from the retracted to the extended position with the inserter assembly in its initial state,

the inserter assembly is transformable from the second to the third state when the inserter is transformed from its initial to its intermediate state, and

the inserter assembly is transformable from the third to the fourth state with the inserter assembly in its intermediate state.

23. A medical device as in claim 21, wherein the inserter assembly has an extended state in which the cannula holder has been moved to further extend the cannula from the needle.

24. A medical device as in claim 23, wherein:

the inserter assembly is transformable from the first to the second state when the inserter assembly is moved from the retracted to the extended position with the inserter assembly in its initial state,

the inserter assembly is transformable from the second to the third state when the inserter is transformed from its initial to its intermediate state,

the inserter assembly is transformable from the third to the fourth state with the inserter assembly in its intermediate state, and

the inserter assembly is transformable from the fourth to the fifth state when the inserter is transformed from its intermediate to its extended state and when the inserter assembly is moved from the extended to the retracted position.

25. A medical device as in any of claim 21, further comprising a flexible sheet member (821) with a lower surface adapted to be arranged on a skin surface of a subject, and an upper surface to which the housing is arranged.

26. An assembly comprising a medical device as in claim 25 and a delivery device (5) adapted to be coupled to the housing, the delivery device comprising a reservoir (760) adapted to contain a fluid drug, and an expelling assembly (300) adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the cannula when the delivery device has been coupled to the housing.

27. A medical device as in claim 1, wherein the cannula is in the form of a sensor device.

28. An assembly comprising a medical device as in claim 1 and a process unit adapted to be coupled to the housing, wherein the cannula is in the form of a sensor device and the process unit is adapted to transmit and/or process data acquired via the sensor.

32. An assembly comprising a medical device (901) as in any of claims 1-15, 17 and 19-25, and a delivery device (902) adapted to be coupled to the housing (923), the delivery device comprising a reservoir adapted to contain a fluid drug, and an expelling assembly adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the cannula (971) when the delivery device has been coupled to the housing, wherein the delivery device in a situation of use in which the medical device has been applied towards the skin of a subject covers the cannula in its extended position.

33. A medical device as in claim 1, further comprising a reservoir adapted to contain a fluid drug, and an expelling assembly adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the cannula, wherein the medical device in a situation of use in which the medical device has been applied towards the skin of a subject covers the cannula in its extended position.

29. A method of inserting a cannula into the subcutaneous tissue of a subject, comprising the steps of:

providing a cannula having a distal end portion adapted to be arranged through the skin of the subject and having a distal opening, and a needle arranged coaxially with and being axially moveable relative to the cannula, the needle comprising a pointed distal end,

advancing the cannula with the distal end of the needle projecting there from through the dermis of the subject,

further advancing the cannula into the sub-cutis of the subject with the distal end of the cannula projecting relative to the needle.

30. A method as in claim 29, wherein the distal end of the needle is arranged short of the distal end of the cannula during advancement of the cannula into the sub-cutis.

31. A method as in claim 29, wherein the needle is arranged either within the cannula or the needle is hollow and arranged outside the cannula.

34. An assembly comprising:

a transcutaneous device unit adapted for application towards a skin surface of a subject and comprising a housing, and an extendable transcutaneous device having a distal end portion adapted to be arranged through the skin of the subject at an inclined angle relative to the skin surface, and

a process unit adapted to be releasably coupled to the housing, the process unit comprising a process assembly adapted for cooperation with the transcutaneous device, wherein the process unit in a situation of use in which the assembly has been applied towards the skin of a subject covers the cannula in its extended position, and wherein at least partial removal of the process unit from the transcutaneous device unit allows inspection of the introduction site of the transcutaneous device through the skin surface.

35. An assembly comprising:

a medical device comprising a housing adapted for application towards a skin surface of a subject, an insertable cannula having a distal end portion with a distal opening and being adapted to be arranged through the skin of the subject at an inclined angle relative to the skin surface, and

a delivery device (902) adapted to be releasably coupled to the housing (923), the delivery device comprising a reservoir adapted to contain a fluid drug, and an expelling assembly adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the cannula (971) when the delivery device has been coupled to the housing, wherein the delivery device in a situation of use in which the medical device has been applied towards the skin of a subject covers the cannula in its extended position, and wherein at least partial removal of the delivery device from the medical device allows inspection of the introduction site of the cannula through the skin surface.