DEVICE AND METHOD FOR ENHANCED SUBCUTANEOUS INSULIN ABSORPTION

• US 20110160697A1
• Filed: 08/27/2009
• Published: 06/30/2011
• Est. Priority Date: 08/28/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Shapira, Gali, Yodfat, Ofer, Gescheit, Illai
• Granted Patent: US 9,387,033 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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

1-65. -65. (canceled)

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

a pump including;

a reservoir for retaining the therapeutic fluid,

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

a controller which controls, at least in part, operation of the driving mechanism, and

a power source which powers at least the driving mechanism and the controller;

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 that causes an increase in the absorption rate of the therapeutic fluid in the body of the patient.

67. The system of claim 66, wherein the first subcutaneously insertable element is a cannula, and wherein the absorption enhancement device comprises at least one electrode associated with the cannula, the electrode being capable of heating local surrounding tissue.

68. The system of claim 67, wherein the at least one electrode is disposed on the cannula.

69. The system of claim 66, wherein the absorption enhancement device comprises a second subcutaneously insertable element, the second subcutaneously insertable element comprises a distal portion configured for subcutaneous placement within the body of the patient and having at least one electrode disposed thereon capable of heating local surrounding tissue.

70. The system of claim 66, wherein the absorption enhancement device is electrically connected to the power source.

71. The system of claim 66, wherein the pump includes at least one housing, and wherein the absorption enhancement device comprises one or more heating plates disposed on the at least one housing to heat the patient'"'"'s skin surface.

72. The system of claim 66, further comprising a skin adherable cradle unit configured for securing the pump to the body of the patient, the cradle unit containing the absorption enhancement device, the absorption enhancement device including one or more heating plates to heat the patient'"'"'s skin surface.

73. The system of claim 66, wherein the pump further comprises another reservoir retaining a vasodilatory agent.

74. The system of claim 73, wherein the absorption enhancement device comprises a second subcutaneously insertable element or an array of micro-needles capable of penetrating the skin to deliver therethrough the vasodilatory agent from the another reservoir to the body of the patient.

75. The system of claim 73, wherein the first subcutaneously insertable element comprises a cannula having a plurality of lumens for delivering therethrough, the therapeutic fluid and the vasodilatory agent to the body of the patient.

76. The system of claim 66, further comprising a sensor for monitoring tissue properties corresponding with a change in therapeutic fluid absorption rate, the controller further controls the operation of the absorption enhancement device and/or the driving mechanism based on a signal received from the sensor.

77. The system of claim 76, wherein the sensor is selected from the group consisting of:

a thermometer measuring temperature, a chemical sensor measuring concentration level of an agent, an electrochemical sensor measuring concentration level of a body analyte, an optical sensor for measuring concentration level of a body analyte, a radiation detector, a pressure sensor, and an acoustic sensor.

78. The system of claim 66, wherein the absorption enhancement device is activated in accordance with a planned meal.

79. The system of claim 66, wherein the therapeutic fluid comprises insulin.

80. The system of claim 73, wherein the vasodilatory agent comprises one of:

nitroglycerin, nitroprusside, histamine, PDE5 inhibitors, sildenafil, and papaverine.

81. A device for delivering therapeutic fluid to a body of a patient comprising:

a pump having a pump housing accommodating;

a reservoir for retaining the therapeutic fluid,

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

a controller which controls, at least in part, operation of the driving mechanism, and

a power source which powers at least the driving mechanism and the controller;

a cannula having a distal end configured for subcutaneous placement and which delivers the therapeutic fluid therethrough to the body of the patient;

optionally a skin adherable cradle for securing the pump to the skin of the patient; and

a heating device which heats local tissue surrounding the cannula and causes an increase in the absorption rate of the therapeutic fluid in the body of the patient, wherein the heating device is disposed at one or more of the pump housing, cannula and cradle.

82. A method for enhancing absorption of a therapeutic fluid in a body of a patient, the method comprising:

providing a pump for delivering the therapeutic fluid to the body of the patient, the pump is associated with at least one cannula for delivering the therapeutic fluid therethrough to the subcutaneous tissue of the patient;

providing an absorption enhancement device for increasing an absorption rate of the therapeutic fluid in the body of the patient;

applying an absorption enhancing stimulus, via the absorption enhancement device, to a therapeutic fluid administration site; and

administering the therapeutic fluid via the at least one cannula.

83. The method of claim 82, wherein the absorption enhancing stimulus is applied prior to and/or after the administration of the therapeutic fluid.

84. The method of claim 82, wherein the absorption enhancing stimulus is applied concurrently with the administration of the therapeutic fluid.

85. The method of claim 82, wherein the absorption enhancing stimulus is selected from the group consisting of subcutaneously applied heat, transdermally applied heat, high frequency vibration, ultrasonic energy, and a vasodilatory agent.