Insertion device

• US 20080319414A1
• Filed: 06/24/2008
• Published: 12/25/2008
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Neta, Avraham, Gescheit, Illai
• Granted Patent: US 9,808,574 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 2005/1426 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 2205/3606 cooled
• CPC Class Codes: A61M 2205/362 by gas flow
• CPC Class Codes: A61M 2205/3673 thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• 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 5/422 Desensitising skin

Abstract

An insertion apparatus and a method for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte are disclosed. The apparatus includes a housing adapted for loading therein at least one cannula cartridge unit having a protective member. The protective member accommodates at least one penetrating cartridge having a subcutaneously insertable element and a penetrating member. The apparatus includes a displacement mechanism capable of protracting the penetrating cartridge towards the body of the patient, where protraction of the penetrating cartridge results in insertion of the subcutaneously insertable element into the body of the patient.

Claims

1. An insertion apparatus for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte, the insertion apparatus comprising:

a housing adapted for loading therein at least one cannula cartridge unit provided with a protective member accommodating therein at least one penetrating cartridge having a subcutaneously insertable element and a penetrating member;

a displacement mechanism which upon actuation is capable of protracting the at least one penetrating cartridge towards the body of the patient;

wherein the protracting of the penetrating cartridge results in inserting of at least the subcutaneously insertable element into the body of the patient.

2. The insertion apparatus according to claim 1, wherein the housing includes a first opening for loading the at least one cannula cartridge unit therein.

3. The insertion apparatus according to claim 2, wherein the housing further includes a second opening for protracting the penetrating cartridge therethrough.

4. The insertion apparatus according to claim 1, wherein the device for fluid delivery and/or for analyte sensing is skin adherable;

the device is provided with an opening through which the insertion apparatus and/or the cannula cartridge unit are coupled to the device;

wherein the penetrating cartridge is protracted through the opening.

5. The insertion apparatus according to claim 1, wherein the device for fluid delivery and/or for analyte sensing includes an infusion set having

an infusion set hub adherable to the skin of the patient;

the infusion set hub includes an infusion set opening through which the insertion apparatus and/or the cannula cartridge unit are coupled to the infusion set;

wherein the penetrating cartridge is protracted through the opening of the infusion set hub.

6. The apparatus according to claim 1, wherein the device for fluid delivery and/or for analyte sensing includes a cradle unit adherable to the body of the patient;

the cradle unit having a well portion through which the penetrating cartridge is protracted;

wherein the insertion apparatus and/or cannula cartridge unit are capable of being coupled to the cradle unit.

7. The insertion apparatus according to claim 1, wherein the displacement mechanism is a rod for manually pushing the penetrating cartridge toward the body of the patient.

8. The insertion apparatus according to claim 1, wherein the displacement mechanism is configured to retract the penetrating member subsequently to insertion of the subcutaneously insertable element.

9. The insertion apparatus according to claim 1, wherein the displacement mechanism includes a loadable spring for forcible displacement of the penetrating cartridge toward the body of the patient.

10. The insertion apparatus according to claim 8, wherein the retraction of the penetrating member is carried out automatically.

11. The insertion apparatus according to claim 1, wherein the displacement mechanism is adapted to displace the penetrating cartridge toward the body of the patient for penetrating the skin of the patient at various angles.

12. The insertion apparatus according to claim 1, wherein therapeutic fluid is insulin and the bodily analyte is glucose.

13. The insertion apparatus according to claim 1, further comprising a safety means for preventing inadvertent actuation of the displacement mechanism.

14. The insertion apparatus according to claim 1, wherein the housing is provided with an ergonomic configuration.

15. The insertion apparatus according to claim 9, wherein the displacement mechanism includes

a release button having a restraining arm;

a ratchet flywheel;

a loadable flywheel torsion spring at least a portion of which is embedded in the ratchet flywheel;

a manually rotatable loading button capable of being coupled to the ratchet flywheel for loading the flywheel torsion spring;

a ratchet crank coupled to the ratchet flywheel and rotatable by the flywheel torsion spring;

an insertion lever provided with at least one engagement hook and displaceable by the ratchet crank;

wherein upon coupling the loading button to the ratchet flywheel and subsequent rotation of the loading button the flywheel torsion spring is loaded; and

wherein upon pressing of the release button, the restraining arm of the release button is disengaged from the ratchet crank allowing the ratchet crank to rotate via an application of force of the loaded flywheel torsion spring;

wherein the ratchet crank displaces the insertion lever and the at least one engagement hook resulting in the protraction of the penetrating cartridge toward the body of the patient and, subsequently, the retraction of the penetrating member, thereby retaining the subcutaneously insertable element in the body of the patient.

16. A method for inserting a subcutaneously insertable element into the body of a patient using an insertion apparatus for use with a device for delivery of therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte, the apparatus having

a housing adapted for loading therein at least one cannula cartridge unit provided with a protective member accommodating therein at least one penetrating cartridge having a subcutaneously insertable element and a penetrating member;

and

a displacement mechanism which upon actuation is capable of protracting the at least one penetrating cartridge towards the body of the patient;

wherein the protracting of the penetrating cartridge results in inserting of at least the subcutaneously insertable element into a subcutaneous compartment of the body of the patient;

the method comprising the steps of;

loading the cannula cartridge unit into the housing;

protracting the penetrating cartridge toward the body of the patient; and

retracting the penetrating member, thereby retaining the subcutaneously insertable element in the body of the patient.

17. The method according to claim 16, wherein the protracting step is performed by the displacement mechanism.

18. The method according to claim 17, wherein the retracting step is performed by the displacing mechanism.

19. The method according to claim 16, wherein the device for delivery of therapeutic fluid into the body of the patient and/or for sensing of bodily analyte includes a cradle unit adherable to the skin of the patient;

the method further comprising the step of;

coupling the housing of the insertion apparatus to the cradle unit.

20. The method according to claim 19, further comprising the step of:

adhering the cradle unit to the body of the patient prior to the coupling of the housing to the cradle unit.

21. The method according to claim 19, further comprising the step of:

adhering the cradle unit to the body of the patient after the coupling of the housing to the cradle unit.

22. The method according to claim 19, further comprising the step of:

uncoupling the housing from the cradle unit.

23. The method according to claim 17, wherein the displacement mechanism includes a loadable spring;

the method further comprising the step of;

loading the loadable spring.