Device and method for enhanced subcutaneous insulin absorption

• US 9,387,033 B2
• Filed: 08/27/2009
• Issued: 07/12/2016
• Est. Priority Date: 08/28/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali, Gescheit, Illai
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US13/060,799
• Publication Number:
  US 20110160697A1
• Time in Patent Office: 2,511 Days
• Field of Search: 604 20- 21, 604113- 11, 604/118, 604/890.144, 604/890.1, 604/44, 604/41, 604 49- 50, 604/181, 604/131, 604/134, 604/185, 604 65- 66
• US Class Current: 1/1
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Products and methods directed to the improved infusion of fluids are disclosed. Such products and methods can be used to more efficiently and efficaciously administer therapeutic pharmaceuticals to a subject in need of treatment. In many instances, the systems comprise a therapeutic fluid delivery system and a mechanism for enhancing the absorption of the therapeutic fluid. The enhancement of the absorption of the therapeutic fluid is generally performed locally i.e., at or near the site of administration of the therapeutic fluid. The system and methods can be used to deliver any number of therapeutic fluids including but not limited to insulin.

Claims

1. A system for delivering a therapeutic fluid to a body of a patient comprising:

a pump including;

a reservoir for retaining the therapeutic fluid,

a driving mechanism which dispenses via pumping the therapeutic fluid from the reservoir to the body of the patient,

electronic components which control, at least in part, operation of the driving mechanism, and

a power supply which powers at least the driving mechanism and the electronic components;

a first subcutaneously insertable element for delivering the therapeutic fluid therethrough to the body of the patient, the first subcutaneously insertable element comprises a distal portion configured for subcutaneous placement within the body of the patient; and

an absorption enhancement device configured to contact and locally heat tissue of the patient surrounding the first subcutaneously insertable element when subcutaneously placed, which causes an increase in absorption rate of the therapeutic fluid in the body of the patient, wherein the electronic components control the operation of the absorption enhancement device, and wherein the electronic components are contained in a reusable part, and that the reservoir is contained in a disposable part, the disposable part also provides the first subcutaneously insertable element and the absorption enhancement device, and wherein the system further comprises a skin adherable cradle unit having an elastically deformable anchoring latch at each opposing end, such that one opposing end of the skin adherable cradle unit extends upward directly against and along an opposing exterior side of the reusable part, and an other opposing end of the skin adherable cradle unit extends upwardly directly against and along an opposing exterior side of the disposable part,

the anchoring latches hold both the reusable part and the disposable part horizontally side-by-side via a snapping engagement of a top portion of the anchoring latches with a pair of lateral notches, where one lateral notch is provided on the opposing exterior sides of the reusable part and an other lateral notch is provided on the opposing exterior side of the disposable part,

and wherein the first subcutaneously insertable element and the absorption enchancement device. extend downwardly in an opening provided in the skin adherable cradle unit such that the distal portion can be placed subcutaneously within the body of the patient, and the absorption enhancement device can contact and locally heat surrounding tissue of the patient when the first subcutaneously insertable element is subcutaneously placed.

2. The system of claim 1, wherein the absorption enhancement device comprises one or more heating plates disposed on the disposable part.

3. The system of claim 2, wherein the first subcutaneously insertable element is a cannula, the disposable part includes an outlet port from which the cannula extends, and wherein the one or more heating plates are arranged concentrically around the outlet port.

4. The system of claim 2, wherein the first subcutaneously insertable element is a cannula, the disposable part includes an outlet port from which the cannula extends, and wherein the one or more heating plates is a rounded heating plate arranged concentrically around the outlet port.

5. The system of claim 1, wherein the first subcutaneously insertable element is a cannula, and wherein the absorption enhancement device comprises at least one electrode associated with the cannula.

6. The system of claims 1, wherein the absorption enhancement device is electrically connected to the power supply.

7. The system of claim 1, wherein the absorption enhancement device is activated in accordance with a planned meal.

8. The system of claim 1, wherein the therapeutic fluid comprises insulin.

9. The system of claim 1, wherein the electronic components control the operation of the absorption enhancement device, wherein the first subcutaneously insertable element is a cannula, wherein the disposable part includes an outlet port from which the cannula extends, the absorption enhancement device comprises one or more heating plates disposed on the disposable part and arranged concentrically around the outlet port, and wherein the absorption enhancement device is electrically connected to the power supply.

10. The system of claim 1, wherein the power supply is provided in the disposable part.

11. The system of claim 1, wherein the power supply is provided in the reusable part.