Tissue monitoring system for intravascular infusion
First Claim
1. A tissue monitoring apparatus comprising:
- a film barrier dressing comprising a flexible membrane integrating one or more sensor elements adapted to interrogate tissue at multiple electrical signal frequencies and an adhesive layer adapted to couple the film barrier dressing to a patient'"'"'s skin;
a control unit adapted to couple to the one or more sensor elements in the film barrier dressing, the control unit adapted to control the sensor elements to interrogate the tissue at selected multiple frequencies, sense one or more electrical signal parameters indicative of tissue condition in three-dimensional space, and execute a complex number three-dimensional pattern recognition operation on the one or more sensed parameters to determine a subcutaneous mapping indicative of a tissue condition;
a bio-impedance sensor including a plurality of sensor elements configured to acquire impedance signals in three-dimensional space; and
an electrical impedance tomography processor executable in the control unit and adapted to execute an object recognition operation on the impedance signals.
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Accused Products
Abstract
An infusion system has a capability to monitor infusion complications such as extravasation, tissue necrosis, infiltration, phlebitis, and blood clots. The infusion system has at least partially transparent flexible film barrier dressing in a flexible membrane that incorporates a plurality of sensors capable of detecting tissue condition and a control unit capable of coupling to the film barrier dressing that monitors signals from the sensors. A device is capable of executing non-invasive physiological measurements to characterize physiologic information from cross-sectional surface and subcutaneous tissue to detect the presence or absence of tissue conditions such as infiltration or extravasation during intravascular infusion. In some examples, the device utilizes depth-selective methods to sense, detect, quantify, monitor, and generate an alert notification of tissue parameters.
278 Citations
37 Claims
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1. A tissue monitoring apparatus comprising:
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a film barrier dressing comprising a flexible membrane integrating one or more sensor elements adapted to interrogate tissue at multiple electrical signal frequencies and an adhesive layer adapted to couple the film barrier dressing to a patient'"'"'s skin; a control unit adapted to couple to the one or more sensor elements in the film barrier dressing, the control unit adapted to control the sensor elements to interrogate the tissue at selected multiple frequencies, sense one or more electrical signal parameters indicative of tissue condition in three-dimensional space, and execute a complex number three-dimensional pattern recognition operation on the one or more sensed parameters to determine a subcutaneous mapping indicative of a tissue condition; a bio-impedance sensor including a plurality of sensor elements configured to acquire impedance signals in three-dimensional space; and an electrical impedance tomography processor executable in the control unit and adapted to execute an object recognition operation on the impedance signals. - 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)
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24. A tissue monitoring apparatus comprising:
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means for flexibly covering and protecting a patient'"'"'s skin; means integrated into the covering and protecting means for sensing one or more biological electrical signal parameters including a bio-impedance parameter sensed from a plurality of elements and interrogating tissue at multiple electrical signal frequencies; means for acquiring three-dimensional biological electrical signal information including three-dimensional impedance signals from the sensing means using tissue interrogation at selected multiple frequencies; means for analyzing patterns in the three-dimensional biological information using an electrical impedance tomography technique; and means for determining a patient tissue condition based on the analyzed patterns. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of monitoring a patient tissue condition comprising:
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attaching a film barrier dressing to a patient skin surface, the film barrier dressing comprising a flexible membrane integrating one or more sensor elements and an adhesive layer capable of coupling to the patient'"'"'s skin; acquiring information indicative of tissue condition via tissue interrogation at selected multiple electrical signal frequencies; communicating information from the one or more sensor elements to a control unit; controlling the sensor elements to sense one or more parameters indicative of tissue condition in three-dimensional space; in a start mode, acquiring information from the one or more sensor elements and recording baseline information; commencing an intravascular infusion operation; in a test mode, acquiring information from the one or more sensor elements and recording test information; and comparing the baseline information and the test information in three-dimensions using electrical impedance tomography using the one or more sensed parameters to determine a tissue condition. - View Dependent Claims (35, 36, 37)
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Specification