Protector apparatus

• US 20080319416A1
• 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
• Granted Patent: US 8,002,752 B2
• Time in Patent Office: Days
• US Class Current: 604/513
• 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 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 is adapted for accommodating at least one subcutaneously insertable element and at least one penetrating member for penetrating the skin of the patient. The apparatus includes a protective member having an elongate body from which the subcutaneously insertable element and the penetrating member can be protracted to penetrate the skin of the patient and into which the penetrating member can be retracted subsequent to the penetrating, thereby retaining the subcutaneously insertable element in the body of the patient.

Claims

1. An 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 apparatus is adapted for accommodating at least one subcutaneously insertable element and at least one penetrating member for penetrating the skin of the patient, the apparatus comprising:

a protective member having an elongate body from which the subcutaneously insertable element and the penetrating member can be protracted to penetrate the skin of the patient and into which the penetrating member can be retracted subsequent to the penetrating, thereby retaining the subcutaneously insertable element in the body of the patient.

2. The apparatus according to claim 1, wherein the protective member is configured to accommodate at least one differently sized and shaped subcutaneously insertable element.

3. The apparatus according to claim 1, wherein the protective member further includes a gripping handle.

4. The apparatus according to claim 1, further comprising a disposable cannula cartridge unit having:

the protective member;

a penetrating cartridge having

the subcutaneously insertable element; and

the penetrating member for penetrating the skin of the patient;

wherein the elongate body of the protective member houses the penetrating cartridge.

5. The apparatus according to claim 4, wherein the elongate body of the protective member includes a lower open end;

wherein the penetrating cartridge is protracted through the lower open end to penetrate the skin of the patient.

6. The apparatus according to claim 5, wherein the penetrating member can be retracted through the lower open end into the protective member.

7. The apparatus according to claim 5, wherein the elongate body of the protective member further includes at least one window to allow access to the penetrating cartridge for protracting the penetrating cartridge toward the body of the patient;

wherein the at least one window is selected from the group consisting of;

an upper open end and a longitudinal slit disposed in the protective member.

8. The apparatus according to claim 5, wherein the device for fluid delivery and/or for analyte sensing is skin adherable;

wherein the device includes an opening through which the cannula cartridge unit is coupled to the device, wherein the subcutaneously insertable element is protracted through the opening.

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

the infusion set having

an infusion set hub adherable to the skin of the patient, the infusion set hub having an infusion set hub opening through which the cannula cartridge unit is coupled to the infusion set;

wherein the subcutaneously insertable element is protracted through the opening in the hub.

10. The apparatus according to claim 5, wherein the device for fluid delivery and/or for analyte sensing includes a cradle unit adherable to the skin of the patient;

wherein the cradle unit having a well portion with an opening;

wherein the cannula cartridge unit is coupled to the well portion, and the subcutaneously insertable element is protracted through the opening in the well portion.

11. The apparatus of claim 4, wherein the subcutaneously insertable element is a cannula and the cannula cartridge unit further includes a cannula hub;

wherein the cannula hub includes a septum for sealing the cannula following retraction of the penetrating member.

12. The apparatus according to claim 11, wherein the cannula is adapted for delivery of therapeutic fluid to the body of the patient.

13. The apparatus according to claim 12, wherein the cannula further includes a sensing means for sensing a bodily analyte.

14. The apparatus according to claim 4, wherein the subcutaneously insertable element is a sensor for sensing the bodily analyte.

15. The apparatus according to claim 4, wherein therapeutic fluid is insulin and the bodily analyte is glucose.

16. The apparatus according to claim 4, further comprising a means for manually pushing the penetrating cartridge toward the body of the patient so as to protract the subcutaneously insertable element and the penetrating member toward the body of the patient in order to penetrate the skin of the patient.

17. The apparatus according to claim 4, wherein the cannula cartridge unit is configured for use with an insertion device.

18. The apparatus according to claim 17, wherein the elongate body of the protective member further includes at least one window to allow access of the insertion device to the penetrating cartridge;

wherein the at least one window is selected from the group consisting of;

an upper open end and a longitudinal slit disposed in the protective member.

19. The apparatus according to claim 18, wherein the insertion device includes a displacement mechanism adapted to allow access to the penetrating cartridge through the at least one window;

the displacement mechanism having a loadable spring for forcible displacement of the penetrating cartridge toward the body of the patient.

20. The apparatus according to claim 19, wherein the displacement mechanism is adapted to displace the penetrating cartridge toward to the body of the patient for penetrating the skin of the patient at various angles.

21. The apparatus according to claim 10, wherein the lower open end of the elongate body of the protective member is securable to the well portion of the cradle unit.

22. A method for inserting a subcutaneously insertable element into a body of a patient using an 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, wherein the apparatus includes a protective member accommodating at least one subcutaneously insertable element and at least one penetrating member for penetrating the skin of the patient, the method comprising the steps of:

protracting the subcutaneously insertable element and the penetrating member from the protective member;

inserting the subcutaneously insertable element and the penetrating member into the body of the patient;

retracting the penetrating member from the body of the patient; and

,

retaining the subcutaneously insertable element in the body of the patient.

23. The method according to claim 22, wherein the device for delivery of therapeutic fluid and/or for sensing of the bodily analyte includes a cradle unit adherable to the skin of the patient and having a well portion;

the method further comprising the step of;

coupling the cannula cartridge unit to the well portion of the cradle unit.

24. The method according to claim 22, further comprising manually performing the protracting and/or retracting steps.

25. The method according to claim 22, further comprising automatically performing the protracting and/or retracting steps.