INSERTION DEVICES FOR INFUSION DEVICES

• US 20090124979A1
• Filed: 09/10/2008
• Published: 05/14/2009
• Est. Priority Date: 09/17/2007
• Status: Active Grant

• Current Assignee: Ypsomed AG (Ypsomed Holding AG)
• Original Assignee: ICU Medical Incorporated
• Inventors: Walker, Joseph K., Lopez, Dan, Raymond, Randy Stephen, Warren, Dee E.
• Granted Patent: US 8,409,145 B2
• Time in Patent Office: Days
• US Class Current: 604/195
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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

An insertion device for inserting an infusion device at least partially into skin for subcutaneous infusion can comprise a sleeve having a lower surface that is configured to engage the skin, a shuttle or carriage to carry the infusion device between a retracted position and an advanced position; at least a first biasing member to urge the shuttle or carriage toward the advanced position, and an actuator to cause the first biasing member to urge the carriage from the retracted position to the advanced position. In some embodiments, the insertion device can further comprise a hub and at least a second biasing member to urge the hub away from the shuttle or carriage. In some embodiments, the insertion device can further comprise a needle attached to the hub. Methods for inserting an infusion device and various other features that can be comprised by an insertion device are also disclosed.

Claims

1. A device for inserting an infusion device through skin for subcutaneous infusion, comprising:

a sleeve having an upper surface and a lower surface, the lower surface being configured to engage skin;

a shuttle comprising a receptacle for accommodating an infusion device, at least a first movement-restraining arm, and a least a first hub-retaining arm, the shuttle being movable between a retracted position and an advanced position, the first movement-restraining arm engaging the upper surface of the sleeve when the shuttle is in the retracted position to inhibit movement of the shuttle toward the advanced position;

at least a first biasing member operatively connected to the shuttle to urge the shuttle toward the advanced position;

a hub having an upper side and a lower side, the hub being movable between a first position and a second position with respect to the shuttle, the first hub-retaining arm of the shuttle inhibiting movement of the hub away from the shuttle when the hub is in the first position;

a needle having an upper end and a lower end, the upper end being fixedly attached to the lower side of the hub, the lower end being configured to pierce skin, the lower end of the needle extending below the lower surface of the sleeve when the shuttle is in the advanced position and the hub is in the first position, the lower end of the needle being positioned above the lower surface of the sleeve when the hub is in the second position;

at least a second biasing member operatively connected to the hub to urge the hub upwardly from the shuttle away from the lower surface of the sleeve;

an actuator being movably attached to the sleeve such that, when the first movement-restraining arm is engaged with the upper surface, advancement of the actuator toward the sleeve permits disengagement the first movement-restraining arm of the shuttle from the upper surface of the sleeve;

wherein disengagement of the first movement-restraining arm of the shuttle from the upper surface of the sleeve allows the first biasing member to move the shuttle from the retracted position to the advanced position; and

wherein movement of the shuttle from the retracted position to the advanced position allows the first hub-retaining arm of the shuttle to release the hub such that the second biasing member moves the hub from the first position to the second position.

2. The device of claim 1, wherein the sleeve further comprises at least one aperture and the actuator further comprises at least one protrusion, wherein the at least one aperture and the at least one protrusion are configured such that the actuator and the sleeve can be rotated between a first position in which the actuator is inhibited from moving toward the lower surface of the sleeve and a second position in which the actuator is movable toward the lower surface to disengage the first movement-restraining arm of the shuttle from the upper surface of the sleeve.

3. The device of claim 1, wherein the shuttle further comprises at least one movable member for engaging the infusion device to inhibit release of the infusion device from the shuttle before the first movement-restraining arm of the shuttle is disengaged from the upper surface of the sleeve.

4. The device of claim 1, wherein the shuttle is received at least partially within the sleeve.

5. The device of claim 1, wherein the first biasing member comprises a spring positioned between the sleeve and the shuttle.

6. The device of claim 1, wherein the hub is received at least partially within the shuttle.

7. The device of claim 1, wherein the second biasing member is comprises a spring positioned between the shuttle and the hub.

8. The device of claim 2, wherein the at least one aperture is located in the upper surface of the sleeve and the at least one protrusion extends downwardly from a lower side of the actuator.

9. The device of claim 3, wherein the at least one movable member is configured to be engaged by the hub when the hub is in the first position to cause contact between the movable member and the infusion device to inhibit release of the infusion device from the shuttle before the first movement-restraining arm of the shuttle is disengaged from the upper surface of the sleeve.

10. The device of claim 3, wherein the at least one movable member is configured to be engaged by a cam surface of the sleeve when the shuttle is in the retracted position to cause contact between the movable member and the infusion device to inhibit release of the infusion device from the shuttle before the first movement-restraining arm of the shuttle is disengaged from the upper surface of the sleeve.

11. An inserter for placing an infusion device at least partially into skin, comprising:

a sleeve having a bottom surface, the bottom surface being configured to engage skin;

a carriage for carrying an infusion device, the carriage positioned at least partially within the sleeve, the carriage being movable between a retracted position and an advanced position, the lowest portion of the infusion device being spaced upwardly from the bottom surface of the sleeve when the carriage is in the retracted position, the bottom portion of the infusion device extending below the lower surface of the sleeve when the carriage is in the advanced position;

at least a first biasing member operatively connected to the carriage to urge the carriage toward the advanced position;

a hub and a needle, the hub being movable between a first position and a second position with respect to the carriage, the needle having an upper end and a lower end, the upper end being fixedly attached to the lower side of the hub, the lower end being configured to pierce skin, the needle extending below the carriage when the hub is in the first position, the lower end of the needle extending no lower than the carriage when the hub is in the second position;

at least a second biasing member operatively connected to the hub to urge the hub upwardly from the carriage away from the lower surface of the sleeve;

an actuator operatively connected to the sleeve to cause the first biasing member to move the carriage from the retracted position to the advanced position;

wherein movement of the carriage from the retracted position toward the advanced position permits the hub to move from the first position to the second position.

12. The inserter of claim 11, wherein the inserter is configured to be removed from the infusion device before infusion commences.

13. The inserter of claim 11, wherein the carriage further comprises at least a first arm configured to engage the sleeve to inhibit movement of the carriage from the retracted position to the advanced position, the arm being engageable by the actuator such that the actuator can disengage the arm from the sleeve to permit the first biasing member to urge the carriage from the retracted position to the advanced position.

14. The inserter of claim 11, wherein the carriage further comprises at least a second arm configured to engage the hub to inhibit movement of the hub from the first position to the second position, the second arm being held in engagement with the hub by the shuttle at least until the lower end of the needle pierces the skin.

15. The inserter of claim 11, wherein the first biasing member engages the carriage and the actuator.

16. The inserter of claim 11, wherein the second biasing member engages the carriage and the hub.

17. The inserter of claim 11, wherein a surface of the insertion device is pressed against an exterior surface of the skin when the carriage is in the advanced position.

18. The inserter of claim 17, wherein the surface of the insertion device is an adhesive surface.

19. An inserter for placing an infusion device at least partially into skin, comprising:

a housing having a bottom surface, the bottom surface being configured to engage skin;

a carriage for carrying an infusion device, the carriage positioned at least partially within the housing, the carriage being movable between a retracted position and an advanced position, the lowest portion of the infusion device being spaced upwardly from the bottom surface of the housing when the carriage is in the retracted position, the bottom portion of the infusion device extending below the lower surface of the housing when the carriage is in the advanced position, the carriage comprising at least one movable member for engaging the infusion device to inhibit release of the infusion device from the carriage before the carriage moves from the retracted position toward the advanced position;

at least a first biasing member operatively connected to the carriage to urge the carriage toward the advanced position;

an actuator operatively connected to the housing to cause the first biasing member to move the carriage from the retracted position to the advanced position;

wherein movement of the carriage from the retracted position toward the advanced position causes the hub to move from the first position to the second position.

20. The device of claim 19, wherein the at least one movable member is configured to be engaged by a cam surface of the housing when the carriage is in the retracted position to cause contact between the movable member and the infusion device to inhibit release of the infusion device from the carriage before the carriage moves from the retracted position toward the advanced position.

21. The device of claim 19, further comprising a hub, wherein the at least one movable member is configured to be engaged by the hub when the hub is in the first position to cause contact between the movable member and the infusion device to inhibit release of the infusion device from the carriage before the carriage moves from the retracted position toward the advanced position.

22. The device of claim 19, wherein the at least one movable member further comprises at least one foot configured to extend under at least a portion of the infusion device when the carriage is in the retracted position.

23. The device of claim 20, wherein the at least one movable member engages the infusion device near an outer periphery of the infusion device.