Protector apparatus

• US 8,628,500 B2
• Filed: 07/27/2011
• Issued: 01/14/2014
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Neta, Avraham
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US13/136,291
• Publication Number:
  US 20110288390A1
• Time in Patent Office: 902 Days
• Field of Search: 60416401-17003, 604/136
• US Class Current: 604/198
• 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. A cartridge unit for loading into an insertion device, the cartridge unit comprising:

a protective member comprising a substantially hollow, elongate housing;

a subcutaneously insertable element; and

a penetrating member configured to penetrate the skin of the patient to enable subcutaneous insertion of the insertable element,

wherein;

the cartridge unit is configured for loading into and unloading out of an insertion device;

the protective member houses at least the subcutaneously insertable element and the penetrating member prior to the insertable element and penetrating member being protracted from the protective member toward the body of the patient by the insertion device for subcutaneous insertion of the insertable element into the body of the patient,

the protective member houses at least the penetrating member after the insertable element has been subcutaneously inserted into the body of the patient and the penetrating member has been retracted into the protective member by the insertion device.

2. The cartridge unit according to claim 1, wherein the cartridge unit is devoid of any integrated displacement mechanism.

3. The cartridge unit according to claim 1, further comprising a handle portion extending out from the elongate housing of the protective member.

4. The cartridge unit according to claim 3, wherein the handle portion is configured:

as a finger-grip for gripping by a user to load the cartridge unit substantially within the insertion device and to unload the cartridge unit therefrom,

and

to protrude a distance away from the insertion device when the cartridge unit is loaded therein.

5. The cartridge unit according to claim 1, wherein the protective member is configured to house a variety of different sized and shaped insertable elements.

6. The cartridge unit according to claim 1, wherein:

the protective member includes a lower open end; and

the insertable element and penetrating member are protracted through the lower open end to penetrate the skin of the patient.

7. The cartridge unit according to claim 6, wherein the penetrating member is retracted through the lower open end into the protective member after subcutaneous insertion of the insertable element into the body of the patient.

8. The cartridge unit according to claim 1, wherein the elongate housing of the protective member includes at least one window to allow access to the interior of the elongate housing for enabling protraction of the insertable element and penetrating member toward the body of the patient.

9. The cartridge unit according to claim 1, wherein the insertable element comprises a cannula including a cannula hub having a septum for sealing the cannula following retraction of the penetrating member.

10. The cartridge unit according to claim 1, wherein the insertable element is configured to deliver therapeutic fluid into the body of the patient.

11. The cartridge unit according to claim 10, wherein the insertable element further includes sensing means for sensing a bodily analyte.

12. The cartridge unit according to claim 1, wherein the insertable element comprises a sensor for sensing a bodily analyte.

13. The cartridge unit according to claim 10, wherein the therapeutic fluid is insulin.

14. The cartridge unit according to claim 11, wherein the bodily analyte is glucose.

15. The cartridge unit according to claim 1, wherein the protective member includes a lower open end configured for securing to a well portion of a therapeutic fluid delivery system.

16. The cartridge unit according to claim 1, wherein the elongate housing includes at least one slit extending along a length of at least as portion of the elongate housing, the at least one slit configured to receive at least a portion of a displacement mechanism of the insertion device for enabling at least the protraction of the insertable element and penetrating member toward the body of the patient.

17. A method for inserting a subcutaneously insertable element into a body of a patient, the method comprising:

loading a cartridge unit into an insertion device, wherein the cartridge unit comprises;

a protective member comprising a substantially hollow, elongate housing,

a subcutaneously insertable element, and

a penetrating member configured to penetrate the skin of the patient to enable subcutaneous insertion of the insertable element,

wherein prior to subcutaneous insertion of the insertable element, the protective member houses at least the insertable element and penetrating member;

protracting the insertable element and the penetrating member from the protective member via the insertion device ultimately resulting in insertion of the insertable element and the penetrating member into the body of the patient; and

retracting the penetrating member from the body of the patient via the insertion device, wherein the subcutaneously insertable element is retained in the body of the patient.

18. The method according to claim 17, further comprising unloading the protective member from the insertion device, wherein after the retracting step, the protective member houses at least the penetrating member.

19. The method according to claim 17, wherein at least one of the protracting and retracting steps is performed manually.

20. The method according to claim 17, wherein at least one of the protracting and retracting steps is performed automatically via a spring loaded mechanism included with the insertion device.

21. The method according to claim 17, wherein the protective member is devoid of any integrated displacement mechanism.