Sensor insertion assembly, sensor cartridge, and inserter

• US 10,653,445 B2
• Filed: 11/25/2014
• Issued: 05/19/2020
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Kube, Oliver, Walter, Helmut, Heck, Wolfgang
• Primary Examiner(s): Herbermann, Erich G
• Application Number:
  US14/553,380
• Publication Number:
  US 20150080684A1
• Time in Patent Office: 2,002 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

A sensor insertion assembly comprising a sensor cartridge having an insertion needle and a sensor within a sterile capsule. The sensor insertion assembly further comprises an inserter comprising a chamber for receiving the sensor cartridge, wherein the inserter further comprises an insertion mechanism operable for actuating the insertion needle for inserting the sensor into a subject. The sensor cartridge is removable from the chamber. The sensor cartridge is operable for shielding the insertion needle upon removal of the sensor cartridge from the chamber.

Claims

1. A sensor insertion assembly, comprising:

a sensor cartridge comprising an insertion needle configured for piercing the skin to create a puncture wound through which a sensor is inserted into the skin, the insertion needle and tip thereof disposed within a sealed sterile capsule;

the sensor being within the sealed sterile capsule, wherein the sensor is within the insertion needle; and

an inserter comprising a chamber for removably receiving the sensor cartridge, the inserter further comprising an actuator operable for actuating the insertion needle for inserting the sensor into a subject;

wherein the sensor cartridge is operable for shielding the insertion needle upon removal of the sensor cartridge from the chamber and after inserting the sensor into the subject.

2. The sensor insertion assembly of claim 1, wherein the actuator is operable for removing at least a portion of the insertion needle from the sterile capsule a predetermined time before inserting the sensor into the subject.

3. The sensor insertion assembly of claim 1, further comprising a magazine having several of the sensor cartridges, wherein the inserter is operable for reloading a second sensor cartridge into the chamber from the magazine after actuation of the actuator, and wherein the magazine is any one of:

a linear magazine and a cylindrical magazine.

4. The sensor insertion assembly of claim 3, wherein the magazine is operable for shielding of the insertion needle after actuation of the actuator.

5. The sensor insertion assembly of claim 1, wherein the sterile capsule comprises a hollow cavity, wherein the actuator comprises a piston and is operable for pushing the piston into the hollow cavity for inserting the insertion needle into the subject, wherein the actuator is further operable for retracting the insertion needle back into the hollow cavity after insertion of the sensor into the subject using the piston.

6. The sensor insertion assembly of claim 1, wherein the sealed sterile capsule comprises a seal.

7. The sensor insertion assembly of claim 6, wherein:

the seal is a septum;

the actuator is operable for pushing the insertion needle through the septum; and

the septum is operable for attaching to a sensor mounting unit.

8. The sensor insertion assembly of claim 6, wherein the seal is a pre-stressed foil, the actuator is operable for pushing the insertion needle through the pre-stressed foil, and the pre-stressed foil is operable for opening the sterile capsule when pierced by the insertion needle.

9. The sensor insertion assembly of claim 6, wherein the actuator is operable for actuating a cable when actuating the insertion needle, and wherein the cable is operable for removing the seal when actuated.

10. The sensor insertion assembly of claim 6, wherein the sterile capsule contains a coil, and wherein the coil is operable for cutting open the seal when the insertion needle is actuated.

11. The sensor insertion assembly of claim 6, wherein the chamber comprises a knife edge mount for receiving the sterile capsule, and wherein the knife edge mount is operable for opening the seal when the actuator is actuated.

12. The sensor insertion assembly of claim 6, wherein one of the sterile capsule and the inserter comprises a spring mechanism, wherein the spring mechanism is operable for being put under stress when the sterile capsule is inserted into the chamber, wherein the spring mechanism is operable for opening the seal when the actuator is actuated.

13. The sensor assembly of claim 6, wherein the actuator is operable for removing the seal automatically during actuation of the insertion needle.

14. The sensor assembly of claim 6, wherein the sensor cartridge further comprises a sensor connector connected to the sensor, wherein the actuator is operable for mounting the sensor connector into a sensor mounting unit upon actuation of the insertion needle, wherein sensor mounting unit comprises a knife edge mount for receiving the sterile capsule, and wherein the knife edge mount is operable for opening the seal.

15. The sensor assembly of claim 1, wherein the sensor cartridge further comprises a sensor connector connected to the sensor, and wherein the actuator is operable for mounting the sensor connector into a sensor mounting unit upon actuation of the insertion needle.

16. A sensor cartridge, comprising:

an insertion needle configured for piercing the skin to create a puncture wound through which a sensor is inserted into the skin, the insertion needle and Up thereof disposed within a sealed sterile capsule;

the sensor being within the sterile capsule, wherein the sensor is within the insertion needle;

wherein the sensor cartridge is removably receivable in a chamber of an inserter; and

wherein the sterile capsule is configured to shield the insertion needle upon removal of the sensor cartridge from the chamber and after inserting the sensor into a subject.

17. A sensor insertion assembly, comprising:

a sensor cartridge comprising an insertion needle and tip thereof disposed within a sterile capsule and a sensor within the sterile capsule, wherein the sensor is within the insertion needle; and

an inserter comprising a chamber for removably receiving the sensor cartridge, the inserter further comprising an actuator operable for actuating the insertion needle for inserting the sensor into a subject, wherein the inserter is configured for use with a magazine having several of the sensor cartridges, wherein the inserter is operable for reloading a second sensor cartridge into the chamber from the magazine after actuation of the actuator, and wherein the magazine is any one of;

a linear magazine and a cylindrical magazine; and

wherein the sensor cartridge is operable for shielding the insertion needle upon removal of the sensor cartridge from the chamber and after inserting the sensor into the subject.

18. The sensor insertion assembly of claim 17, wherein the magazine is operable for the shielding of the insertion needle after actuation of the actuator.

19. The sensor insertion assembly of claim 17, wherein the sterile capsule comprises a seal for sealing the sterile capsule.

20. The sensor insertion assembly of claim 19, wherein:

the seal is a septum;

the actuator is operable for pushing the insertion needle through the septum; and

the septum is operable for attaching to a sensor mounting unit.

21. The sensor assembly of claim 19, wherein the actuator is operable for removing the seal automatically during actuation of the insertion needle.

22. A sensor insertion assembly, comprising:

a sensor cartridge comprising an insertion needle and tip thereof disposed within a sterile capsule and a sensor within the sterile capsule, wherein the sensor is within the insertion needle; and

an inserter comprising a chamber for removably receiving the sensor cartridge, the inserter further comprising an actuator operable for actuating the insertion needle for inserting the sensor into a subject;

wherein the sensor cartridge is operable for shielding the insertion needle upon removal of the sensor cartridge from the chamber and after inserting the sensor into the subject; and

wherein the sterile capsule comprises a hollow cavity and the actuator comprises a piston operable to enter the hollow cavity.

23. The sensor insertion assembly of claim 22, wherein the actuator is operable for pushing the piston into the hollow cavity for inserting the insertion needle into the subject.

24. The sensor insertion assembly of claim 23, wherein the actuator is further operable for retracting the insertion needle back into the hollow cavity after insertion of the sensor into the subject using the piston.

25. The sensor insertion assembly of claim 22, wherein the sterile capsule comprises a seal for sealing the sterile capsule.

26. The sensor insertion assembly of claim 25, wherein:

the seal is a septum;

the actuator is operable for pushing the insertion needle through the septum; and

the septum is operable for attaching to a sensor mounting unit.