DEVICE FOR DRUG DELIVERY AND ASSOCIATED CONNECTIONS THERETO

• US 20100286467A1
• Filed: 03/19/2008
• Published: 11/11/2010
• Est. Priority Date: 03/19/2007
• Status: Abandoned Application

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Pesach, Benny, Bitton, Gabriel, Nagar, Ron, Weiss, Ram
• Application Number:
  US12/450,249
• Publication Number:
  US 20100286467A1
• Time in Patent Office: Days
• US Class Current: 600/9
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• 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 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

Embodiments of the present invention are directed to systems, apparatuses, devices and methods for improving, modifying and/or stabilizing pharmacokinetic and/or pharmacodynamic profile of a drug infused into the tissue by a catheter and absorbed into the blood or lymphatic system. In some embodiments, infusion sets provide fluid and electrical connection between a catheter assembly/treatment element and at least one of a fluid source and a second source.

Claims

1-75. -75. (canceled)

76. An infusion apparatus for delivering a therapeutic fluid from a fluid source to a patient comprising:

a catheter assembly including;

a catheter housing;

a catheter capable of insertion transcutaneously into a patient;

a fluid inlet port in fluid communication with the catheter; and

a treatment element capable of providing a treatment adjacent a catheter;

at least one electrical contact in electrical communication with the treatment element;

a securing element for securing catheter assembly to the patient;

a connector assembly capable of providing electrical connection and fluid communication between the catheter assembly and the fluid source, including;

a fluid delivery tube capable of communicating therapeutic fluid from the fluid source to the catheter assembly; and

at least one electrical wire in electrical communication with the at least one electrical contact.

77. The apparatus according to claim 76, wherein the connector assembly includes

a catheter connector capable of connection with the catheter assembly, the connector assembly, including

a catheter connector housing;

the fluid delivery tube capable of communicating therapeutic fluid from a fluid unit to a catheter positioned within the catheter housing upon connection of the catheter connector assembly with the catheter assembly;

at least a second electrical contact; and

,

the at least one electrical wire in electrical communication with the at least second electrical contact; and

,

a fluid connector capable of connection with the fluid unit, including

a fluid unit connector housing;

a fluid receiving port capable of receiving therapeutic fluid from the fluid unit upon connection of the fluid connector with the fluid unit; and

,

at least a third electrical contact in communication with the at least one electrical wire capable of allowing electrical communication with at least a fourth electrical contact provided on the at least of the fluid unit and a second unit.

78. The apparatus according to claim 77, further comprising a controller that controls operation of the treatment element.

79. The apparatus according to claim 76, wherein fluid source includes an insulin pump.

80. The apparatus according to claim 77, wherein the catheter assembly includes at least one sensor.

81. The apparatus according to claim 77, wherein the electrical wires of the connector assembly are embedded into a wall of the fluid delivery tube.

82. The apparatus according to claim 81, further comprising a movable or removable cover provided with the catheter housing and capable of covering at least one of the at least one electrical contact and the fluid inlet port at least prior to use.

83. The apparatus according to claim 82, wherein the cover is manually removable, such that removing the cover exposes at least one of the first electrical contact and the fluid inlet port.

84. The apparatus according to claim 82, wherein the cover is rotatable, such that rotating the cover exposes at least one of the first electrical contact and the fluid inlet port.

85. The apparatus according to claims 82, further comprising a locking member for locking the catheter connector assembly to the catheter assembly.

86. The apparatus according to claim 76, wherein the treatment element is capable of applying at least one of the treatments selected from the group consisting of:

heating, cooling, intermittent temperature change, temperature stabilization, mechanical vibration, acoustic vibration, massaging, ultrasound, suction, electric current, magnetic field, electric field, optical energy, radio frequency irradiation, and microwave irradiation.

87. The apparatus according to claim 77, further comprising:

monitoring means disposed on at least one of the fluid unit and the second unit and configured to limit usage of the infusion apparatus based on a number of uses of the infusion apparatus within a predetermined period of time beginning with a first usage of the infusion apparatus.

88. The apparatus according to claim 87, further comprising

identification means to provide a unique identifier for at least one of the components selected from a group consisting of:

the catheter assembly, the catheter connector, the fluid connector, the treatment element, and packaging of at least one of the catheter assembly, the catheter connector, the fluid connector, and the treatment element;

wherein the fluid source and/or the second source include means for electronically reading the identification means.

89. The apparatus according to claim 88, wherein the identification means is selected from a group consisting of:

a 1-Wire EEPROM, a memory element, a RFID tag, and an optical barcode.

90. The apparatus according to claim 77, further comprising

electronic calibration means to provide a calibration for a component of the apparatus or system.

91. The apparatus according to claim 80, wherein the sensor is at least one sensor selected from the group consisting of:

a temperature sensor, bodily analyte sensor, a motion sensor, a radiation sensor, and a RF sensor.

92. A method of delivering therapeutic fluid to a patient, the method comprising the steps of:

providing an infusion set for infusing therapeutic fluid to a patient, the infusion set comprising;

a treatment element capable of providing a treatment adjacent a catheter

at least one first electrical contact;

a catheter assembly including;

a catheter housing;

a catheter capable of insertion transcutaneously into a patient, wherein the catheter is in fluid communication with the fluid inlet port;

a fluid inlet port in fluid communication with the catheter; and

a movable or removable cover capable of covering at least one of the at least one electrical contact and the fluid inlet port at least prior to use;

a catheter connector assembly capable of connection with the catheter assembly, the connector assembly including;

a catheter connector housing;

a fluid delivery tube capable of communicating therapeutic fluid from a fluid source to the catheter upon connection of the catheter connector assembly with the catheter assembly,

at least one second electrical contact, and

at least one electrical wire in electrical communication with the at least one second electrical contact;

a fluid source connector assembly capable of connection with at least the fluid source, the source connector assembly including;

a fluid source connector housing;

a fluid receiving port capable of receiving therapeutic fluid from the fluid source upon connection of the source connector assembly with the fluid source, and

at least one third electrical contact in communication with the at least one electrical wire capable of allowing electrical communication a fourth electrical contact provided on at least one of the fluid source and a second source;

and

a securing member for securing at least one of the treatment element, catheter assembly and catheter connector assembly to the patient;

transcutaneously inserting the catheter into the patient, the insertion being either with the catheter alone, or as part of the catheter assembly;

securing at least one of the treatment element, catheter assembly and catheter connector assembly to the patient;

connecting the catheter connector assembly to the catheter, wherein such connection can occur either before or after transcutaneous insertion of the catheter;

securing the source connector assembly to at least the fluid source;

enabling the fluid source to deliver therapeutic fluid to the patient via the catheter;

applying treatment via the treatment element either before, during and/or after delivering the therapeutic fluid;

optionally monitoring at least one of a body analyte, temperature, fluid source activation; and

optionally applying the treatment based on the monitoring.

93. A method of delivering therapeutic fluid to a patient, the method comprising the steps of:

providing an infusion set for infusing therapeutic fluid to a patient, the infusion set comprising;

a treatment element capable of providing a treatment adjacent a catheter;

at least one first electrical contact;

a catheter assembly including;

a catheter housing;

a catheter capable of insertion transcutaneously into a patient, wherein the catheter is in fluid communication with the fluid inlet port;

a fluid inlet port in fluid communication with the catheter; and

a catheter connector assembly capable of connection with the catheter assembly, the connector assembly including;

a catheter connector housing;

a fluid delivery tube capable of communicating therapeutic fluid from a fluid source to the catheter upon connection of the catheter connector assembly with the catheter assembly,

at least one second electrical contact, and

at least one electrical wire in electrical communication with the at least one second electrical contact;

a fluid source connector assembly capable of connection with at least the fluid source, the source connector assembly including;

a fluid source connector housing;

a fluid receiving port capable of receiving therapeutic fluid from the fluid source upon connection of the source connector assembly with the fluid source, and

at least one third electrical contact in communication with the at least one electrical wire capable of allowing electrical communication a fourth electrical contact provided on at least one of the fluid source and a second source;

and

a securing member for securing at least one of the treatment element, catheter assembly and catheter connector assembly to the patient;

transcutaneously inserting the catheter into the patient, the insertion being either with the catheter alone, or as part of the catheter assembly;

securing at least one of the treatment element, catheter assembly and catheter connector assembly to the patient;

connecting the catheter connector assembly to the catheter, wherein such connection can occur either before or after transcutaneous insertion of the catheter;

securing the source connector assembly to at least the fluid source;

enabling the fluid source to deliver therapeutic fluid to the patient via the catheter; and

applying treatment via the treatment element either before, during and/or after delivering the therapeutic fluid.

94. The method according to claim 93, wherein the infusion set includes

identification means for identifying the infusion set;

monitoring means for limiting the usage of the infusion set;

the method further comprises

using a controller, identifying the infusion set;

using the controller, calculating a usage period of the infusion set;

terminating usage of the infusion set usage when a limitation on the usage period is reached.

95. The method according to claim 94, wherein the identification means is capable of providing a unique identifier for components selected from a group consisting of:

the catheter assembly, the catheter connector, the fluid source connector, the treatment element and packaging of at least one of the catheter assembly, the catheter connector assembly, the source connector assembly, and the treatment element.