Transcutaneous Device Assembly

• US 20090054866A1
• Filed: 01/24/2006
• Published: 02/26/2009
• Est. Priority Date: 01/24/2005
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Jensen, Jens Peter, Teisen-Simony, Claude, Rorvig, Simon
• Granted Patent: US 8,167,841 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• 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 having a distal portion adapted to be arranged through the skin of the subject, and an outer needle 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 subsequently retract the needle.

Claims

1. An assembly (900) for insertion of a cannula, comprising:

a housing,

a needle (932) comprising a distal portion adapted to be inserted through the skin of a subject,

a needle holder (930) for moving the needle,

a flexible cannula comprising a distal portion (951) adapted to be arranged subcutaneously in the subject, the distal portion of the cannula being arranged in sliding parallel relationship with the distal portion of the needle,

a cannula holder (940) for moving the cannula relative to the needle,

the assembly having an initial state in which the needle holder and the cannula holder are arranged in a first retracted respectively a retracted position, the needle and cannula thereby being arranged in an initial retracted position relative to the housing,

actuator means (960) for moving the needle holder and the cannula holder to an extended respectively a first extended position, the needle and the cannula thereby being moved to an extended position relative to the housing,

actuator means (960) for moving the needle holder to a second retracted position, thereby retracting the needle relative to the housing, and for moving the cannula holder relative to the needle holder and relative to the housing to a second extended position, thereby extending the cannula relative to the needle.

2. An assembly as in claim 1, wherein the needle holder (930) is moveable along a first axis defined by the distal portion of the needle, the cannula holder (940) being coupled to the needle holder and being moveable relative thereto between a first and a second position, the first position corresponding to the retracted position and the first extended position, the second position corresponding to the second extended position,

whereby the cannula holder is arranged substantially at the first position when the needle holder is moved from the first retracted position to the extended position.

3. An assembly as in claim 2, wherein the cannula holder is moved from the first to the second position substantially simultaneously with the needle holder being moved from the extended to the second retracted position.

4. An assembly as in claim 2, wherein the position of the distal cannula portion relative to the housing is substantially the same when the cannula holder is in its first and second extended positions.

5. An assembly as in claim 2, wherein the position of the distal cannula portion relative to the housing is substantially the same during movement of the cannula holder between its first and second extended position.

6. An assembly as in claim 5, wherein the distal cannula portion is moved slightly back and forth relative to the housing during movement of the cannula holder between its first and second extended position.

7. An assembly as in claim 2, wherein the cannula holder is moveable along a second axis defined by the needle holder.

8. An assembly as in claim 7, wherein the second axis is substantially perpendicular to the first axis.

9. An assembly as in claim 1, comprising a first guide (913) and a second guide (914), the cannula holder being adapted to engage the first guide as it is moved from its retracted to its first extended position, and adapted to engage the second guide as it is moved between its first and second extended position.

10. An assembly as in claim 1, comprising a third guide (921), the needle holder being adapted to engage the third guide as it is moved from its first retracted to its extended position, and from its extended position to its second retracted position.

11. An assembly as in claim 9, wherein the cannula holder and the needle holder are coupled to each other, and wherein the actuator means (961, 962) engages the cannula holder as it is moved between its first and second position in engagement with the second guide, the coupling providing that the needle holder thereby is moved from its extended to its second retracted position.

12. An assembly as in claim 9, wherein the actuator means comprises a spring (960), the spring being adapted to engage and move the needle holder (930) from its first retracted position to its extended position, and subsequently engage the cannula holder (940) and move it between its first and second position in engagement with the guide, the needle holder thereby being moved from its extended to its second retracted position.

13. An assembly as in claim 1, wherein the distal end of the cannula is arranged slightly proximally of the distal end of the needle as the needle and the cannula are being moved to their extended position relative to the housing.

14. An assembly as in claim 1, wherein the cannula (952) is moved relative to the needle along a non-linear path.

15. An assembly as in claim 1, wherein the distal portion of the needle is tubular and the distal portion of the cannula is arranged coaxially therein.

16. An assembly as in claim 15, comprising a channel provided proximally of the needle (932) and being arranged non-coaxially therewith, wherein a portion (952) of the cannula is introduced through the channel into the needle when the cannula holder (940) is moved between its first and second position.

17. An assembly as in claim 16, wherein a portion of the channel is formed between the cannula holder and the needle holder.

18. An assembly as in claim 17, wherein the cannula holder comprises a lock (946) for locking the cannula in position relative to the cannula holder, the lock having an open position in which the cannula can be introduced into the channel and further into the needle, and a locked position in which the cannula is locked to the cannula holder.

19. An assembly as in claim 15, wherein the distal portion of the needle has an outer diameter of 0.6 mm or less, and the distal portion of the cannula has an outer diameter of 0.4 mm or less.

20. An assembly as in claim 15, wherein the distal portion of the needle has an outer diameter of 0.5 mm or less, and the distal portion of the cannula has an outer diameter of 0.35 mm or less.

21. A medical device, comprising a mounting surface (904) adapted for application towards a skin surface of a subject, and an assembly as claim 1.

22. A medical device as in claim 21, wherein the distal portion of the needle and the cannula are arranged at an inclined angle relative to the mounting surface.

23. A medical device comprising a first unit (1010) and a second unit (1050), the first unit being a transcutaneous device unit comprising an assembly as defined claim 1, the transcutaneous device being in the form of the flexible cannula, the first unit further comprising:

a housing adapted for application towards a skin surface of a subject, and

a transcutaneous device having a distal portion adapted to be arranged through the skin of the subject in a situation of use in which the housing has been applied towards a skin surface of the subject,

the second unit being adapted to be releasably coupled to the first unit thereby, in a situation of use, substantially covering an introduction site of the transcutaneous device through the skin, and

wherein at least partial removal of the second unit from the first unit at least partially uncovers the introduction site.

24. A medical device, comprising a transcutaneous device unit and a process unit, the transcutaneous device unit comprising:

an assembly as defined in claim 1, the cannula being hollow,

a fluid port (955) in fluid communication with the flexible cannula,

a mounting surface (904) adapted for application to the skin of the subject, the process unit comprising;

a reservoir (760) adapted to contain a fluid drug, 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 fluid port and the flexible cannula, and a processor (583) for controlling the expelling assembly.

25. A medical device (900), comprising:

a housing (905, 910, 901) comprising a mounting surface (904) adapted for application towards the skin of a subject,

a cannula (951) having a distal portion adapted to be arranged through the skin of the subject, and

a hollow needle (932) arranged coaxially with and outside the cannula and being axially moveable relative thereto, the needle comprising a distal portion 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 mounting surface with the distal end of the needle projecting relative to the distal portion of the cannula thereby allowing the cannula to be introduced through the skin of the subject, and

a third state in which the distal end of the needle is retracted relative to the distal portion of the cannula.

27. A medical device as in claim 25, wherein the distal portion of the needle has an outer diameter of 0.6 mm or less, and the distal portion of the cannula has an outer diameter of 0.4 mm or less.

28. A medical device as in claim 25, wherein the distal portion of the needle has an outer diameter of 0.5 mm or less, and the distal portion of the cannula has an outer diameter of 0.35 mm or less.

26. A medical device, comprising:

a mounting surface adapted for application towards a skin surface of a subject,

a hollow needle comprising a distal portion adapted to be inserted through the skin of a subject,

a flexible cannula comprising a distal portion adapted to be arranged subcutaneously in the subject, the distal portion of the cannula being arranged within or in parallel with the distal portion of the needle, wherein

the hollow needle is moveable from an extended position to a retracted position relative to the mounting surface.

29. A method of inserting a cannula, comprising:

providing a medical device comprising a cannula and a hollow insertion needle in a retracted state, the cannula being arranged coaxially within the needle,

arranging the medical device on a skin surface,

inserting a distal portion of the cannula and the needle through the skin of the subject, and

retracting the distal portion of the needle relative to the distal portion of the cannula.

30. A method of inserting a cannula, comprising:

providing a medical device comprising a cannula and a hollow insertion needle extending from the medical device, the cannula being arranged coaxially within the needle,

arranging the medical device on a skin surface, thereby inserting a distal portion of the cannula and the needle through the skin of the subject, and

retracting the distal portion of the needle relative to the distal portion of the cannula.