External inserter for transcutaneous device

• US 20060095014A1
• Filed: 10/14/2005
• Published: 05/04/2006
• Est. Priority Date: 05/08/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Ethelfeld, Erik Winkel
• Granted Patent: US 8,029,469 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• 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 first unit and a releasably attachable second unit. The first unit comprises a mounting surface adapted for application to the skin of a subject, and a transcutaneous device comprising a distal pointed end adapted to penetrate the skin of the subject, wherein the transcutaneous device has a first position in which the distal end is retracted relative to the mounting surface, and a second position in which the distal end projects relative to the mounting surface. The second unit comprises actuatable driving means adapted to move the transcutaneous device from the first position to the second position when the driving means is actuated with the second unit attached to the first unit. By this arrangement the first unit can be applied to the skin of the subject using the second unit as a gripping and handling means, whereafter the driving means can be actuated for insertion of the transcutaneous device.

Claims

1. A medical device (100) comprising a first unit and a releasably attached or attachable second unit, the first unit (150) comprising:

a mounting surface (151) adapted for application to the skin of a subject,

a transcutaneous device (260) comprising a distal pointed end adapted to penetrate the skin of the subject,

the transcutaneous device having a first position in which the distal end is retracted relative to the mounting surface, and a second position in which the distal end projects relative to the mounting surface, the second unit (110) comprising;

actuatable driving means (140) adapted to move the transcutaneous device from the first position to the second position when the driving means is actuated with the second unit attached to the first unit.

2. A medical device as defined in claim 1, wherein the driving means comprises spring means (140, 440), the second unit further comprising:

actuation means (120) actuatable from a first condition through an intermediate condition to a second condition,

whereby actuation of the actuation means from the first to the intermediate condition causes activation of the driving means, and actuation of the actuation means from the intermediate to the second condition causes release of the activated spring means thereby moving the transcutaneous device from the first position to the second position.

3. A medical device as defined in claim 2, wherein the actuation means comprises an actuating element (120) which is moved from a first position through an intermediate position to a second position, preferably corresponding to a substantially non-composite movement.

4. A medical device as defined in claim 2, wherein actuation of the actuation means from the first through the intermediate to the second condition is accomplished by moving two actuation elements (420, 430) relative to each other, preferably against each other.

5. A medical device as defined in claim 4, wherein the transcutaneous device is associated with transfer means (551) upon which the driving means acts to thereby move the transcutaneous device.

6. A medical device as defined in claim 3, wherein the driving means can be locked in its activated state.

7. A medical device as defined in claim 1, wherein the driving means comprises spring means (540) which is or can be arranged in an activated state, the second unit comprising trigger means (542) for releasably retaining the spring means in the actuated state, the trigger means being operable to release the spring means for moving the transcutaneous device from the first position to the second position.

8. A medical device as defined in claim 1, wherein the second unit has an interior space (115) for at least partially accommodating the first unit and an opening through which the first member can be moved when detached from the second unit, the mounting surface facing away from the interior space.

9. A medical device as defined in claim 8, further comprising a seal member (113), the opening being surrounded by a circumferential portion (111) of the second unit to which portion the seal member is releasably attached, thereby providing a closed space for the first unit.

10. A medical device as defined in claim 9, wherein the second unit comprises a housing (110) defining the interior space, the first unit comprising an upper portion (156) facing towards the interior space, the driving means (140) being arranged within the interior space between the upper portion and the housing.

11. A medical device as defined in claim 9, wherein the circumferential portion defines a general plane, the mounting surface being generally planar and arranged substantially corresponding to the general plane.

12. A medical device as defined in claim 1, wherein the mounting surface comprises adhesive means for attaching the first unit to the skin of the subject.

13. A medical device as defined in claim 9, wherein the mounting surface comprises adhesive means for adhering the first unit to the skin of the subject, the seal member being releasably attached to the adhesive means.

14. A medical device as defined in claim 1, wherein the transcutaneous device is a hollow infusion needle (260, 460), the first unit further comprising:

a reservoir (270, 470) adapted to contain a liquid drug and comprising in a situation of use an outlet in fluid communication with the infusion needle, and

expelling means for expelling a drug out of the reservoir and through the skin of the subject via the hollow needle.

15. A medical device as defined in claim 1, wherein the transcutaneous device is in the form of a needle sensor (760) comprising sensor means capable of being influenced by a body substance and producing a signal corresponding thereto.

16. A medical device as defined in claim 1, wherein the transcutaneous device is a cannula (860) in combination with a pointed insertion needle (880) accommodated at least partially within the cannula, the cannula having a distal opening,

the cannula and insertion needle being arranged to be simultaneously moved by the driving means from their respective first position to their respective second position when the driving means is actuated,

wherein the insertion needle is arranged to be moveable away from the distal opening when the cannula and the insertion needle have been moved to their second position.

17. A medical device as defined in claim 16, wherein the cannula comprises a needle-penetratable septum (861) through which the insertion needle is arranged when the cannula and the insertion needle is moved from their respective first position to their respective second position.

18. A medical device as defined in claim 1, wherein the transcutaneous device is a longitudinal sensor device (760) in combination with a pointed insertion needle (770) arranged to support a distal portion of the sensor device,

the sensor device and insertion needle being arranged to be simultaneously moved by the driving means from their respective first position to their respective second position when the driving means is actuated,

wherein the insertion needle is arranged to be moveable away from the distal portion when the sensor device and the insertion needle have been moved to their second position.

19. A medical device as defined in claim 16, wherein the insertion needle in its second position is attached to the second unit, whereby removal of the second unit from the first unit withdraws the insertion needle therefrom.

20. A method of applying a medical device to a skin surface of a subject, comprising the steps:

a) providing a medical device having a first unit and a releasably attached second unit, the first unit comprising;

a generally planar mounting surface comprising adhesive means for adhering the first unit to the skin of the subject,

a transcutaneous device comprising a distal pointed end adapted to penetrate the skin of the subject, the transcutaneous device having a first position in which the distal end is retracted relative to the mounting surface, and a second position in which the distal end projects relative to the mounting surface, the second unit comprising;

an interior space accommodating the first unit and having an opening through which the first unit can be moved when detached from the second unit, the second unit having a circumferential portion defining a general plane and surrounding the opening, the mounting surface being and arranged substantially corresponding to the general plane,

a seal member releasably attached to the circumferential portion, thereby providing a closed space for the first unit,

actuatable driving means adapted to move the transcutaneous device from the first position to the second position when the driving means is actuated with the second unit attached to the first unit,

b) removing the seal member,

c) arranging the adhesive means in contact with the skin of the subject,

d) actuating the driving means thereby moving the transcutaneous device into the skin of the subject,

e) removing the second unit from the first unit.

21. A method as defined in claim 20, wherein the seal member is releasably attached to the adhesive means, whereby the adhesive means is exposed when the seal member is removed.