Portable infusion pump with cannula inserter and pain reduction mechanism

• US 8,715,232 B2
• Filed: 06/25/2008
• Issued: 05/06/2014
• Est. Priority Date: 06/25/2007
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Gescheit, Illai
• Primary Examiner(s): Bouchelle, Laura
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US12/452,187
• Publication Number:
  US 20100106088A1
• Time in Patent Office: 2,141 Days
• Field of Search: 604/112, 604/113, 604/114, 604/115
• US Class Current: 604/112
• 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 for insertion of a subcutaneously insertable element within a body of a patient is described: The apparatus is used for delivery of a therapeutic fluid into a body of a patient and/or sensing of a bodily analyte The apparatus allows alleviating of pain associated with the penetrating of the skin of the patient during needle insertion.

Claims

1. A system for delivery of a therapeutic fluid to a body of a patient and/or for sensing of a bodily analyte comprising:

a device suitable for at least one of delivery of the therapeutic fluid and sensing of the bodily analyte, the device including a skin adherable portion having a first opening;

a subcutaneously insertable element and a penetrating member configured to be protracted through the opening to penetrate a skin of the patient; and

an insertion apparatus removably coupleable to the skin adherable portion of the device, the insertion apparatus comprising;

a housing adapted for accommodating therein at least one penetrating cartridge which includes the subcutaneously insertable element and the penetrating member;

a displacement mechanism configured to protract the penetrating cartridge towards the body of the patient;

wherein protraction of the penetrating cartridge results in penetration of the skin by the penetrating member and insertion of at least the subcutaneously insertable element into the body of the patient; and

at least one pain reduction mechanism for alleviating pain associated with the penetrating of the skin by the subcutaneously insertable element and the penetrating member, the at least one pain reduction mechanism comprising;

a first portion provided by the insertion apparatus; and

receiving means provided by the skin adherable portion for receiving the first portion and allowing the first portion to protrude through the skin adherable portion when the insertion apparatus is coupled to the skin adherable portion.

2. The system according to claim 1, wherein the skin adherable portion of the device is selected from a group consisting of:

a dispensing unit, a sensing device, a cradle unit, and a hub of an infusion set.

3. The system according to claim 1, wherein the first portion of the at least one pain reduction mechanism is disposed at a bottom portion of the housing, wherein the bottom portion is configured to face the skin of the patient.

4. The system according to claim 3, wherein the at least one pain reduction mechanism is detachably connected to the bottom portion of the housing.

5. The system according to claim 3, wherein the first potion of the at least one pain reduction mechanism comprises a plurality of protrusions;

and

wherein the receiving means of the at least one pain reduction mechanism comprises a plurality of second openings adjacent the first opening, the second openings being configured and arranged to correspond to the plurality of protrusions such that upon coupling the insertion apparatus to the skin adherable portion of the device, the plurality of protrusions protrude through the plurality of corresponding second openings.

6. The system according to claim 5, wherein at least some of the plurality of protrusions include a sharp end.

7. The system according to claim 5, wherein at least some of the plurality of protrusions include a blunt end.

8. The system according to claim 5, wherein each of the plurality of protrusions has a length in a range of about 1 mm to about 5 mm and a diameter in a range of about 50 μ

m to about 2000 μ

m.

9. The system according to claim 3, wherein the first portion of the at least one pain reduction mechanism comprises one or more cooling plates;

and

wherein the receiving means of the at least one pain reduction mechanism comprises one or more windows corresponding to the cooling plates of the first portion such that upon coupling the insertion apparatus to the skin adherable portion of the device, the one or more cooling plates fit within the one or more corresponding windows.

10. The system according to claim 1, wherein the at least one pain reduction mechanism comprises a thermoelectric cooler such that the first portion of the at least one pain reduction mechanism comprises at least one cooling plate disposed at a bottom portion of the housing of the insertion apparatus, wherein the bottom portion is configured to face the skin of the patient;

and

wherein the temperature of the at least one cooling plate is lowered upon application of voltage to the thermoelectric cooler.

11. The system according to claim 10, wherein the receiving means of the at least one pain reduction mechanism includes at least one window corresponding to the at least one cooling plate such that upon coupling the insertion apparatus to the skin adherable portion of the device, the at least one cooling plate is accommodated by the at least one corresponding window.

12. The system according to claim 1, wherein the at least one pain reduction mechanism includes a container having a cooling substance releasable towards the skin of the patient.

13. The system according to claim 12, wherein the cooling substance container includes an outlet port and is coupled to an actuation mechanism;

wherein upon actuation of the actuation mechanism the cooling substance is released from the container via the outlet port.

14. The system according to claim 1, wherein the insertion apparatus further comprises a protective member accommodating therein the at least one penetrating cartridge, wherein the protective member is adapted for loading into the housing.

15. The system according to claim 1, wherein the displacement mechanism comprises a rod for manually pushing the penetrating cartridge toward the body of the patient.

16. The system 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.

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

18. The system according to claim 1, wherein the receiving means is configured to provide a secure connection between the skin adherable portion and the insertion apparatus.

19. The system according to claim 1, wherein the receiving means comprises bridges, and the first portion of the at least one pain reduction mechanism comprises grooves configured to fit over the grooves of the receiving means when the insertion apparatus is coupled to the skin adherable portion.

20. The system according to claim 1, wherein the insertion apparatus does not fully protrude through the skin adherable portion of the device.

21. A system for delivery of a therapeutic fluid to a body of a patient and/or for sensing of a bodily analyte comprising:

a skin-adherable device suitable for at least one of delivery of the therapeutic fluid and sensing of the bodily analyte, the device defining a first opening;

a subcutaneously insertable element and a penetrating member configured to be protracted through the opening to penetrate a skin of the patient;

an insertion apparatus removably coupleable to the skin adherable device, the insertion apparatus comprising;

a housing adapted for accommodating therein at least one penetrating cartridge which includes the subcutaneously insertable element and the penetrating member;

a displacement mechanism configured to protract the penetrating cartridge towards the body of the patient, and insert the penetrating member and the subcutaneously insertable element through the skin and into the body of the patient; and

a first pain reduction means for alleviating pain associated with the penetrating of the skin by the subcutaneously insertable element and the penetrating member;

wherein the skin-adherable device further comprises receiving means for receiving the first pain reduction means and allowing the first pain reduction means to protrude through the skin adherable device when the insertion apparatus is coupled to the skin adherable device;

the receiving means being arranged adjacent to the first opening.

22. The system according to claim 21, wherein the receiving means comprises a plurality of second openings surrounding the first opening.

23. The system according to claim 21, wherein the skin-adherable device further comprises a second pain reduction means for alleviating pain associated with the penetrating of the skin by the subcutaneously insertable element and the penetrating member.

24. The system according to claim 23, wherein the second pain reduction means comprises one or more cooling plates.

26. The system according to claim 21, wherein the first pain reduction means comprises a plurality of protrusions disposed at a bottom portion of the protective member.

27. The system according to claim 21, wherein the receiving means comprises a plurality of second openings surrounding the first opening.

25. A system for delivery of a therapeutic fluid to a body of a patient and/or for sensing of a bodily analyte comprising:

a skin-adherable device suitable for at least one of delivery of the therapeutic fluid and sensing of the bodily analyte, the device defining a first openings;

a subcutaneously insertable element and a penetrating member configured to be protracted through the opening to penetrate a skin of the patient;

an insertion apparatus removably coupleable to the skin adherable device, the insertion apparatus comprising;

a protective member accommodating therein a penetrating cartridge which includes the subcutaneously insertable element and the penetrating member;

the protective member comprising a first pain reduction means for alleviating pain associated with the penetrating of the skin by the subcutaneously insertable element and the penetrating member;

a housing adapted for accommodating therein the protective member;

a displacement mechanism configured to protract the penetrating cartridge towards the body of the patient, and insert the penetrating member and the subcutaneously insertable element through the skin and into the body of the patient; and

wherein the skin-adherable device further comprises receiving means for receiving the first pain reduction means and allowing the first pain reduction means to protrude through the skin adherable device when the insertion apparatus is coupled to the skin adherable device;

the receiving means being arranged adjacent to the first opening.

28. A system for delivery of a therapeutic fluid to a body of a patient and/or for sensing of a bodily analyte comprising:

a device suitable for at least one of delivery of the therapeutic fluid and sensing of the bodily analyte, the device including a skin adherable portion having a first opening through which a subcutaneously insertable element and a penetrating member are capable of being protracted to penetrate a skin of the patient;

an insertion apparatus removably coupleable to the skin adherable portion of the device, the insertion apparatus comprising;

a housing adapted for accommodating therein at least one penetrating cartridge including the subcutaneously insertable element and the penetrating member;

a displacement mechanism configured to protract the penetrating cartridge towards the body of the patient;

wherein protraction of the penetrating cartridge results in penetration of the skin by the penetrating member and insertion of at least the subcutaneously insertable element into the body of the patient; and

at least one pain reduction mechanism for alleviating pain associated with the penetrating of the skin by the subcutaneously insertable element and the penetrating member, the at least one pain reduction mechanism comprising;

a first portion provided by the insertion apparatus; and

receiving means provided by the skin adherable portion which is configured to receive the first portion and allow the first portion to protrude through the skin adherable portion without penetrating the skin of the patient when the insertion apparatus is coupled to the skin adherable portion.

29. The system according to claim 28, wherein the first portion protruding through the receiving means without penetrating the skin of the patient comprises the first portion protruding through the skin adherable portion to apply pressure to the skin adjacent the opening.