DEVICE, SYSTEM AND METHOD FOR SUBCUTANEOUS DRUG DELIVERY

• US 20160022905A1
• Filed: 03/04/2014
• Published: 01/28/2016
• Est. Priority Date: 03/05/2013
• Status: Active Application

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: BITTON, Gabriel, NAGAR, Ron
• Application Number:
  US14/773,298
• Publication Number:
  US 20160022905A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2205/051 with radiation therapy
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/057 with magnetotherapy
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61M 5/48 having means for varying, regulating, indicating or limiting injection pressure A61M5/142 takes precedence ; monitoring pressure in infusion systems A61M5/16854
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Embodiments of the present disclosure present systems, methods and devices relate to delivering a drug subcutaneously to a patient. For example, a subcutaneous drug delivery device for use in delivering a drug subcutaneously to a patient can include a needle or cannula configured for delivery of a drug from a drug reservoir to a subcutaneous tissue of a patient.

Claims

1-63. -63. (canceled)

64. A subcutaneous drug delivery device for use in delivering a drug subcutaneously to a patient, the device comprising:

a needle or cannula configured for delivery of a drug from a drug reservoir to a subcutaneous tissue of a patient;

a treatment element configured to modify delivery of the drug into the circulatory system of the patient by application of a treatment via a surface of skin based on at least one property of the drug and/or at least one property of a drug depot, wherein the drug depot comprises an area of tissue surrounding the needle or cannula;

at least one sensor configured to generate at least one signal determinative of the at least one property and generate a sensor signal representative thereof; and

a controller to receive the sensor signal and configure treatment by the treatment element based on the at least one property, wherein the at least one property of the drug comprises at least one of a pharmacokinetic and pharmacodynamics profile of the drug.

65. The device of claim 64, wherein the application of treatment includes at least one of the following:

heating, cooling, mechanical vibrations, suction, massaging, acoustic stimulation, electromagnetic radiation, magnetic stimulation, radio frequency irradiation, microwave irradiation, electrical stimulation, Transcutaneous Electrical Nerve Stimulation (TENS), an additional substance, drugs, medicament, chemicals, biologically active bacteria, biologically inactive bacteria or a combination thereof.

66. The device of claim 64, wherein the determined property of the drug comprises at least one of:

an amount of drug remaining at the drug depot;

a concentration of the drug in the circulatory system based upon measurement of the drug concentration remaining at the drug depot as a function of time; and

a flow rate of the drug in the circulatory system based upon the measurement of the drug concentration remaining at the drug depot as a function of time.

67. The device of claim 64, wherein the sensor is at least one of the following:

provided on or adjacent the needle or cannula;

provided on or adjacent the treatment element;

spaced away from the needle or cannula; and

spaced away from the treatment element.

68. The device of claim 64, further comprising a second sensor configured to perform at least one of the following:

generate at least one signal for identifying at least one of an injection or infusion of the drug through the needle or cannula; and

identify whether the injection or infusion is a basal or bolus dose of the drug.

69. The device of claim 64, wherein the drug comprises an intravenously and/or intradermaly administrated drug.

70. The device of claim 69, wherein the intravenously and/or intradermaly administrated drug comprises a large molecule drug.

71. The device of claim 69, wherein the intravenously and/or intradermaly administrated drug comprises a biological drug.

72. The device of claim 69, wherein the intravenously and/or intradermaly administrated drug comprises a cancer chemotherapy drug.

73. The device of claim 69, wherein the intravenously and/or intradermaly administrated drug comprises a low solubility drug and/or a low permeability drug.

74. The device of claim 69, wherein the intravenously and/or intradermaly administrated drug comprises a drug configured for large dose delivery.

75. The device of claim 69, wherein the intravenously and/or intradermaly administrated drug comprises an irritating agent or toxic drug or drug configured for rapid delivery.

76. The device of claim 64, wherein the treatment element applies the treatment for maintaining a predetermined pharmacokinetic profile from the delivery of the drug up to any one of:

a few hours, a day, two days, three days, a week, two weeks, a month, and a few months.

77. The device of claim 64, wherein the at least one property comprises a blood perfusion of the drug depot and/or in proximity to the drug depot.

78. The device of claim 77, wherein the determined blood perfusion corresponds to a degree of vasodilatation which is induced by treatment applied by the treatment element.

79. A method for delivering a drug subcutaneously to a patient comprising:

providing a subcutaneous drug delivery device configured to deliver a drug subcutaneously to a patient, the device comprising;

a drug reservoir configured to contain a drug;

a needle or cannula configured for delivery of the drug from the drug reservoir to a subcutaneous tissue of the patient;

a treatment element configured to modify delivery of the drug into the circulatory system of the patient by application of a treatment via a surface of skin based on at least one property of the drug and/or at least one property of a drug depot, wherein the drug depot comprises an area of tissue surrounding the needle or cannula;

at least one sensor configured to generate at least one signal determinative of the at least one property; and

a controller to receive the at least one signal and configure treatment by the treatment element based on the at least one property;

delivering the drug subcutaneously via at least one of the needle and cannula;

determining a concentration of the drug at the drug depot, and wherein the concentration corresponds to at least one signal generated by the sensor; and

activating, increasing, decreasing or de-activating the treatment element upon the concentration being different than a desired concentration.

80. The method of claim 79, wherein at least one of a pharmacokinetic and pharmacodynamics profile of the drug is maintained at a desired profile.

81. The method of claim 80, wherein maintaining the desired profile includes maintaining the concentration of the drug in the drug depot below, above, or at a predetermined concentration.

82. The method of claim 79, wherein treatment element comprises a heater and a cooling element, and wherein the method further comprises at least one of alternately and intermittently heating the drug depot by the heater and cooling the drug depot by the cooling element to control or modify at least one of a pharmacokinetic and/or pharmacodynamic profile of the drug.

83. The method of claim 79, wherein the treatment element is controlled to control the concentration of the drug in the circulatory system of the patient.