Sensor integrated biopsy needle system
Inventors
DELGADO ALONSO, JESUS • Lieberman, Robert • Berry, David
Assignees
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Publication Number
US-11202590-B2
Publication Date
2021-12-21
Expiration Date
Abstract
Disclosed is a system which adds biochemical sensitivity to a standard biopsy needle such that the practitioner is provided immediate feedback on the metabolism and physiology of tissue in the local environment. Disclosed is a sensor integrated biopsy device for in situ and real time tissue analysis. The sensor integrated biopsy (SIB) needle system will enable biopsy teams to measure local tissue biochemistry in real time during biopsy procedures, adding a valuable new set of parameters to augment and extend conventional image-guided procedures.
Core Innovation
The invention is a sensor integrated biopsy (SIB) needle that integrates optical-fiber chemical sensors into a biopsy device for real-time biochemical feedback during biopsy. The device includes a coaxial needle and a hollow trocar that includes at least one sensor window covered by a permeable medical-grade material, so that the sensor region is exposed to tissue for sensing.
At least one sensor includes at least one source optical fiber connected to a light source and at least one detector optical fiber connected to a light detector, bundled in a single optical fiber lead tipped with a chemically sensitive luminescent dye-doped polymer material. The sensor is capable of sensing at least one target analyte in real time by a detected luminescent change of the chemically sensitive luminescent material in contact with the target analyte in tissue.
The sensor detects luminescence changes in the presence of lactate, and a concentration of lactate is measured by phase-resolved luminescence detection that measures a time delay between excitation of the chemically sensitive luminescent dye-doped polymer material by blue light and emission of red light. The disclosed approach supports monitoring of tissue metabolism by correlating sensor measurements for biochemical signature discrimination within tissue, and supports multi-sensor sensing for additional biochemical targets, including pH and oxygen.
Claims Coverage
The document includes three independent claims covering a sensor integrated biopsy (SIB) needle structure, a method for obtaining a biopsy sample using real-time tumor-location guidance, and a system with a display and tissue removal device to determine optimal biopsy location. Across the independent claims, there are three core inventive features.
Coaxial needle with hollow trocar sensor window
A coaxial needle; and a hollow trocar, wherein the hollow trocar includes at least one sensor window having a permeable medical-grade material covering.
Optical fiber lead tipped with chemically sensitive luminescent dye-doped polymer
At least one sensor comprising at least one source optical fiber connected to a light source and at least one detector optical fiber connected to a light detector, bundled in a single optical fiber lead and tipped with at least one chemically sensitive luminescent dye-doped polymer material, capable of sensing at least one target analyte in real time by a detected luminescent change in tissue.
Phase-resolved luminescence detection measuring time delay for lactate concentration
The sensor detects luminescence changes in the presence of lactate, and a concentration of lactate is measured by phase-resolved luminescence detection measuring time delay between excitation by blue light and emission of red light.
Display-based monitoring of sensor signals indicating needle location inside tumor
Monitoring on a display, at least one sensor signal from the at least one sensor for sensor signal levels indicating a tip of the SIB needle is located inside a cancerous tumor.
Replacing hollow trocar with biopsy tissue removal component
Removing the hollow trocar from the coaxial needle; inserting a biopsy tissue removal component into the coaxial needle; removing a portion of tissue for testing using the biopsy tissue removal component.
Display showing real-time needle position and chemical readouts for optimal biopsy location
A display showing position of the needle in real-time and a readout of chemical measurements detected by the at least one sensor, used to determine the optimal location within tissue for removing a biopsy sample.
The claim coverage centers on an SIB needle with a coaxial needle and a hollow trocar sensor window using permeable medical-grade material, optical-fiber source and detector fibers bundled in a single optical fiber lead tipped with a chemically sensitive luminescent dye-doped polymer, and measurement of lactate concentration using phase-resolved luminescence detection. The method and system claims further require real-time display of sensor signal information, and in the system claim real-time needle position, to guide biopsy location and support tissue removal.
Stated Advantages
Provides real-time biochemical feedback during biopsy by sensing target analytes via luminescent changes.
Measures lactate concentration using phase-resolved luminescence detection based on time delay between blue-light excitation and red-light emission.
Enables monitoring and correlation of sensor readouts for determining an optimal location within tissue for removing a biopsy sample by using real-time chemical measurements and real-time needle position.
Helps indicate the tip of the SIB needle is located inside a cancerous tumor via sensor signal levels on a display.
Documented Applications
Used for obtaining a biopsy sample from a region of tissue to be tested for a cancerous tumor by inserting the SIB needle into the region tissue and monitoring sensor signals indicating the needle tip location.
Used to determine the optimal location within tissue for removing a biopsy sample by a user monitoring readouts of real-time chemical measurements together with real-time needle position on a display.
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