Active electrode, bio-impedance based, tissue discrimination system and methods of use
First Claim
1. A tissue discrimination system, comprising:
- a sensor circuit selected from the group of a voltage sensor, a current sensor and a combination of a voltage and a current sensor;
a waveform electrode having an area no more than approximately 10 mm2, the waveform electrode electrically coupled to the sensor circuit;
a return electrode electronically coupled to the sensor circuit; and
a controller electronically coupled to the sensor circuit and configured to;
cause an electrical signal to be applied to the waveform electrode and the return electrode, the electrical signal having a frequency between approximately 500 Hz and approximately 2500 Hz;
receive a signal from the sensor circuit; and
using the signal received from the sensor circuit, calculate a result useful for discriminating tissue.
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Accused Products
Abstract
Systems and methods for discriminating and locating tissues within a body involve applying a waveform signal to tissue between two electrodes and measuring the electrical characteristics of the signal transmitted through the tissue. At least one of the electrodes is constrained in area so that localized electrical characteristics of the tissue are measured. Such localized electrical characteristics are determined over a portion of a body of the subject by using an array of electrodes or electrodes that can be moved over the body. A controller may implement the process and perform calculations on the measured data to identify tissue types and locations within the measured area, and to present results in graphical form. Results may be combined with other tissue imaging technologies and with image-guided systems.
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Citations
114 Claims
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1. A tissue discrimination system, comprising:
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a sensor circuit selected from the group of a voltage sensor, a current sensor and a combination of a voltage and a current sensor;
a waveform electrode having an area no more than approximately 10 mm2, the waveform electrode electrically coupled to the sensor circuit;
a return electrode electronically coupled to the sensor circuit; and
a controller electronically coupled to the sensor circuit and configured to;
cause an electrical signal to be applied to the waveform electrode and the return electrode, the electrical signal having a frequency between approximately 500 Hz and approximately 2500 Hz;
receive a signal from the sensor circuit; and
using the signal received from the sensor circuit, calculate a result useful for discriminating tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A wireless electrode array system suitable for tissue discrimination applications, comprising:
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a controller;
a sensor circuit electronically coupled to the controller, the sensor circuit being selected from the group of a voltage sensor, a current sensor and a combination of a voltage and a current sensor;
an electrode array assembly containing a plurality of waveform electrodes, each of the plurality of waveform electrodes having an area no more than approximately 10 mm2;
a switch assembly electronically coupled to the plurality of waveform electrodes, to the sensor circuit and to the controller;
a return electrode electrically coupled to the sensor circuit;
a signal generator electronically coupled to the controller and electrically coupled to the switch assembly and the return electrode, the signal generator being configured to receive a control signal from the controller and, in response to the control signal, generate an electrical signal applied to the waveform electrode and the return electrode; and
a wireless datalink coupled to the controller, the wireless datalink being configured to receive data from the controller and transmit the data via datalink communications, and to receive commands via datalink communications and provide the commands to the controller, wherein the switch assembly is configured to electrically connect a selected waveform electrode to the sensor circuit and to the signal generator in response to a control signal received from the controller, and the controller is configured to send control signals to the signal generator and the switch assembly, receive data signals from the sensor circuit, receive commands provided by the wireless datalink, and send data signals to the wireless datalink for transmission. - View Dependent Claims (34, 35, 36, 37, 38, 39)
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40. A roller electrode array assembly, comprising:
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a handle;
a cylinder rotatably coupled to the handle;
an array of electrodes disposed about an external surface of the cylinder, each electrode in the array of electrodes being electrically connected to an electrical lead;
a rotatable electrical connector electrically connected to each electrical lead. - View Dependent Claims (41, 42, 43, 44, 45)
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46. An electrode assembly, comprising:
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a body configured to be held in one hand by an operator;
an electrical conductor coupled to the body at an end;
an electrical contactor having a distal and proximal end, where the electrical contactor is coupled to the body at the proximal end and electrically coupled to the electrical conductor, and the distal end comprises an energized portion having an area equal to or less than approximately 10 mm2 when placed in contact with skin of a subject. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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53. A pad for application on skin of a subject for use with a tissue discrimination system, comprising:
a pad comprising insulator material suitable for direct application on the skin of the subject, the pad having disposed therein a means for enabling an electrical connection to be made between an electrode and the skin of the subject within an area limited to approximately 10 mm2 or less. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. A grid assembly for use with a tissue discrimination system which employs an electrode array assembly;
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a frame assembly defining an array of openings each having a shape and size which permits the electrode array assembly to be positioned therein; and
a fiducial marker coupled to the frame and configured to be sensed by an external position sensing system. - View Dependent Claims (65, 66)
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67. An image guided medical system, comprising:
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a tissue discrimination subsystem, comprising;
a sensor circuit selected from the group of a voltage sensor, a current sensor and a combination of a voltage and a current sensor;
a waveform electrode having an area no more than approximately 10 mm2, the waveform electrode electrically coupled to the sensor circuit;
a return electrode electronically coupled to the sensor circuit; and
a controller electronically coupled to the sensor circuit and configured to cause an electrical signal to be applied to the waveform electrode and the return electrode, the electrical signal having a frequency between approximately 500 Hz and approximately 2500 Hz, receive a signal from the sensor circuit, using the signal received from the sensor circuit, calculate a result useful for discriminating tissue, and store the calculated result in a database; and
an image guided medical subsystem configured to guide a medical procedure using tissue discrimination data stored in the database by the tissue discrimination subsystem. - View Dependent Claims (68, 69, 70, 71, 72, 73, 74)
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75. A tissue imaging and discrimination sensor comprising:
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a pad comprised of electrical insulating material;
a plurality of electrodes disposed within the pad; and
an ultrasound transducer disposed within the pad. - View Dependent Claims (76, 77, 78, 79, 80, 81)
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82. A subcutaneous electrode array assembly suitable for use with a tissue discrimination system, comprising:
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a frame;
a plurality of needle electrodes coupled to the frame;
an electrical conductor coupled to the frame, electrically coupled to each of the plurality of needle electrodes, and configured to be connect to a signal generator of a tissue discrimination system.
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83. A method of discriminating tissue within a subject, comprising:
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placing a waveform electrode on skin of the subject, wherein the waveform electrode has an area no more than approximately 10 mm2;
placing a return electrode on skin of the subject at a position on the skin removed from the waveform electrode;
applying a signal to the electrode array and the return electrode;
measuring a change in a characteristic of the signal resulting from transmission through tissue between the waveform and return electrodes; and
processing the measured change in the characteristics of the signal to discriminate a tissue located beneath the waveform electrode. - View Dependent Claims (84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100)
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101. A method of applying anesthesia to a subject, comprising:
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placing an array of waveform electrodes on skin of the subject;
placing a return electrode on skin of the subject at a position on the skin removed from the array of waveform electrodes;
for each waveform electrode within the array applying a signal to a selected one of the waveform electrodes within the array and the return electrode, measuring a change in a characteristic of the signal resulting from transmission through tissue between the selected waveform and return electrodes, and processing the measured change in the characteristics of the signal to determine impedance of tissue between the selected waveform and return electrodes;
using the determined impedance for each waveform electrode within the array to determine a location of a nerve beneath the array; and
applying anesthesia to the nerve using the determined location. - View Dependent Claims (102, 103)
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104. A method of correcting electrical impedance tomography results, comprising:
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placing an array of waveform electrodes on skin of the subject;
placing a return electrode on skin of the subject at a position on the skin removed from the array of waveform electrodes;
for each waveform electrode within the array applying a signal to a selected one of the waveform electrodes within the array and the return electrode, measuring a change in a characteristic of the signal resulting from transmission through tissue between the selected waveform and return electrodes, and processing the measured change in the characteristics of the signal to determine impedance of tissue between the selected waveform and return electrodes;
using the determined impedance for each waveform electrode within the array to determine a location of a nerve beneath the array; and
applying a correction factor to electrical impedance tomography results to account for a preferential conductive path through the nerve.
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105. A method of determining nerve density within a subject, comprising:
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placing an array of waveform electrodes on skin of the subject;
placing a return electrode on skin of the subject at a position on the skin removed from the array of waveform electrodes;
for each waveform electrode within the array applying a signal to a selected one of the waveform electrodes within the array and the return electrode, measuring a change in a characteristic of the signal resulting from transmission through tissue between the selected waveform and return electrodes, and processing the measured change in the characteristics of the signal to determine impedance of tissue between the selected waveform and return electrodes;
using the determined impedance for each waveform electrode within the array to determine locations of nerve beneath the array; and
calculating a density of nerve within the subject based upon the determined locations of nerve beneath the array.
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106. A method of performing a medical procedure, comprising:
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placing a waveform electrode on skin of the subject;
placing a return electrode on skin of the subject at a position on the skin removed from the waveform electrode;
applying a signal to the waveform electrode and the return electrode;
measuring a change in a characteristic of the signal resulting from transmission through tissue between the waveform and return electrodes;
processing the measured change in the characteristics of the signal to discriminate a tissue located beneath the waveform electrode, and performing the medical procedure using the tissue discrimination information. - View Dependent Claims (107, 108, 109, 110, 111, 112, 113, 114)
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Specification