Infusion medium delivery system, device and method with needle inserter and needle inserter device and method

• US 8,226,615 B2
• Filed: 11/24/2008
• Issued: 07/24/2012
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Bikovsky, Rafael
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US12/277,186
• Publication Number:
  US 20090082728A1
• Time in Patent Office: 1,338 Days
• Field of Search: 604/131, 604/134, 604/136, 604/139, 604/151, 604/152, 604/164.01, 604/164.07, 604/164.12, 604/167.01, 604/181, 604/187, 604/200, 604/201, 604/205, 604/218, 604/240, 604/244, 604/48, 604/890.1, 604/93.01, 604/135
• US Class Current: 604/164.12
• 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 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• 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 2005/3289 with rotation of the needle, e.g. to ease penetration
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, includes a needle inserter device and method for inserting a needle and/or cannula into a patient-user. The needle inserter device and method operate to insert a needle and cannula into a patient-user'"'"'s skin and automatically withdraw the needle from the patient-user, leaving the cannula in place and in fluid flow communication with a reservoir. The delivery device may include a base portion and a durable portion connectable to the base portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The base portion supports the reservoir and the needle inserter device, while the durable portion supports a drive device.

Claims

1. A needle injector system comprising a plunger device and a needle injector device for connection in fluid-flow communication with a reservoir, the needle injector device comprising:

a moveable needle supported for movement between a retracted position and an extended position;

a carriage supported for movement with the moveable needle, between the retracted position and the extended position;

a hollow needle or cannula attached to the carriage and moveable with the carriage between the retracted position and the extended position, the hollow needle or cannula having a hollow interior defining a fluid flow channel through at least a portion of the hollow interior;

a locking structure for locking the carriage and the hollow needle or cannula in the extended position, upon the carriage and the hollow needle or cannula being moved to the extended position;

a first fluid flow passage arranged to be out of fluid flow communication with the fluid flow channel of the hollow needle or cannula when the carriage and the hollow needle or cannula are in the retracted position and to operatively couple the fluid flow channel of the hollow needle or cannula in fluid flow communication with the reservoir, upon the carriage and the hollow needle or cannula being moved to the extended position; and

a bias member operatively coupled to the moveable needle, for imparting a force to move the moveable needle toward the retracted position to a location at which the moveable needle is outside of the fluid flow channel of the hollow needle or cannula and outside of the first fluid flow passage, once the carriage and the hollow needle or cannula are locked in the extended position by the locking structure; and

the plunger device configured for selective engagement and disengagement with the needle injector device, the plunger device having a moveable plunger arranged to impart a force to move the moveable needle from the retracted position to the extended position when the plunger device is in engagement with the needle injector device, and to release the moveable needle and allow the moveable needle to move toward the retracted position under the force imparted by the bias member when the plunger device is in disengagement with the needle injector device.

2. The needle injector system of claim 1, wherein the needle injector device further comprises a housing structure in which the first fluid flow passage is arranged, the housing structure supporting the locking structure.

3. The needle injector system of claim 2, wherein the housing structure is securable to a patient-user'"'"'s skin and wherein the hollow needle or cannula is located in a position to extend into the patient-user'"'"'s skin, upon the housing structure being secured to the patient-user'"'"'s skin and the carriage and the hollow needle or cannula being locked in the extended position.

4. The needle injector system of claim 2, wherein the housing structure includes an opening through which a portion of the plunger device may be inserted for imparting the force on the moveable needle in a direction for moving the moveable needle from the retracted position to the extended position.

5. The needle injector system of claim 4, wherein the moveable needle comprises a needle head arranged to be contacted by the plunger device when the plunger device is inserted through the opening in the housing structure.

6. The needle injector system of claim 1, wherein the bias member comprises a spring.

7. The needle injector system of claim 1, wherein the needle injector device further comprises a housing structure supporting the locking structure, the housing structure including a base that is securable to a patient-user'"'"'s skin and wherein the hollow needle or cannula is located in a position to extend into the patient-user'"'"'s skin, upon the base of the housing structure being secured to the patient-user'"'"'s skin and the carriage and the hollow needle or cannula being locked in the extended position.

8. The needle injector system of claim 7, wherein the first fluid flow passage is arranged in the housing structure.

9. The needle injector system of claim 1, wherein the hollow needle or cannula has a distal end configured to be arranged external to a patient-user'"'"'s skin when the carriage and the hollow needle or cannula are in the extended position and wherein the first fluid flow passage is arranged to operatively connect in fluid flow communication with the distal end of the hollow needle or cannula when the carriage and the hollow needle or cannula are moved to the extended position.

10. The needle injector device of claim 1, wherein the carriage comprises:

a body having a second fluid flow passage in fluid flow communication with the fluid flow channel of the hollow needle or cannula;

a further hollow needle connected in fluid flow communication with the second fluid flow passage and arranged in a position at which the further hollow needle connected in fluid flow communication with the first fluid flow passage when the carriage and the hollow needle or cannula are moved to the extended position.

11. The needle injector system of claim 1, wherein the moveable needle is arranged at least partially within the hollow needle or cannula when the carriage and the hollow needle or cannula are in the retracted position.

12. The needle injector system of claim 11, wherein the needle injector device further comprises a septum through which the moveable needle extends when the moveable needle is at least partially within the hollow needle or cannula.

13. The needle injector system of claim 1, wherein the moveable needle is arranged at least partially within the hollow needle or cannula as the carriage and the hollow needle or cannula are moved from the retracted position to the extended position.

14. The needle injector system of claim 13, wherein the needle injector device further comprises a septum through which the moveable needle extends when the moveable needle is at least partially within the hollow needle or cannula.

15. The needle injector system of claim 14, wherein the septum is carried by the carriage.

16. The needle injector device system of claim 13, wherein the needle injector device further comprises a septum through which the moveable needle extends when the moveable needle is at least partially within the hollow needle or cannula, the moveable needle being at a location at which it does not extend through the septum once the carriage and the hollow needle or cannula are locked in the extended position by the locking structure and the moveable needle is moved toward the retracted position to the location at which the moveable needle is outside of the fluid flow channel of the hollow needle or cannula and outside of the first fluid flow passage.

17. The needle injector device system of claim 1, wherein the plunger device is configured to be separated from the needle injector device when the plunger device is in disengagement with the needle injector device.

18. The needle injector device system of claim 17, wherein the needle injector device further comprises a housing structure in which the first fluid flow passage is arranged and wherein the moveable needle remains within the housing structure after the plunger device is disengaged and separated from the needle injector device.

19. The needle injector device system of claim 17, wherein the moveable plunger of the plunger device is arranged at a position to engage the moveable needle of the needle injector device when the plunger device is in engagement with the needle injector device, and to disengage and separate from the moveable needle when the plunger device is in disengagement with and separated from the needle injector device.

20. The needle injector device system of claim 1, in which the moveable plunger of the plunger device is urged by a spring toward an extended position when the moveable plunger is in a retracted position.

21. The needle injector system of claim 1, wherein the moveable plunger of the plunger device is urged by a spring to impart the force of the plunger on the moveable needle when the plunger device is in engagement with the needle injector device, the force of the plunger overcoming the force imparted on the moveable needle by the bias member, to move the moveable needle toward the extended position against the force imparted by the bias member.

22. The needle injector system of claim 1, wherein the needle injector device further comprises a housing structure in which the first fluid flow passage is arranged, the housing structure having an opening through which a plunger head of the plunger device may be inserted for imparting the force on the moveable needle in a direction for moving the moveable needle from the retracted position to the extended position.

23. The needle injector system of claim 22, in which the plunger head of the plunger device is configured to be removed from the housing structure, through the opening of the housing structure, as the plunger device is disengaged from the needle injector device, after the plunger head has imparted the force on the moveable needle and moved the moveable needle from the retracted position to the extended position.