Minimally invasive system for assessment of organ function

• US 6,519,485 B2
• Filed: 12/13/2000
• Issued: 02/11/2003
• Est. Priority Date: 12/13/2000
• Status: Expired due to Fees

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Prokop, Adrian, Milne, Jason, Urias, Adrian Richard, Jarka, Kristopher, Ghassemi, Farbod, Wiesmann, William P., Uyeno, Jill
• Primary Examiner(s): Freay, Charles G.
• Assistant Examiner(s): Liu, Han L
• Application Number:
  US09/736,603
• Publication Number:
  US 20020072661A1
• Time in Patent Office: 790 Days
• Field of Search: 600/327, 600/328, 600/320, 600/322, 600/323, 600/309, 600/342, 600/549, 600/310, 600/339, 600/341, 604/19, 604/48, 604/93.01, 604/113, 604/22, 604/506, 604/19.22, 606/1, 606/27, 607/96, 607/113
• US Class Current: 600/328
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/4244 liver

Abstract

A system for assessing organ function couples light emitters into an optical fiber delivery assembly of which the tip extends to or into an internal organ and illuminates tissue; the device senses temperature at the tip, and a collection fiber collects light scattered, reflected or emitted by the surrounding tissue. Control and processing modules drive the laser diodes and process return spectral signals, e.g., to assess metabolic activity and detect onset of shock. A prototype uses four laser diodes with peaks at 735, 760, 805 and 890 nm, with a front end splitter providing a reference beam to a photo detector for normalizing detection output and correcting the signal samples. The device may include a plurality of laser diodes and may select subsets of the sources to tailor spectral illumination to different target enzymes, metabolites or other compounds. The processor may include heuristic correlators for interpreting the physiological state or detecting the onset of shock based on magnitudes of multiple different measured parameters.

Claims

1. A system for monitoring the function of an organ in a patient, wherein the organ contains one or more target substances, each having a characteristic spectral band, such system comprising:

a detecting component, disposed within a probe having a tissue-penetrating tip, for collecting data relating to a plurality of physiological parameters of the organ, wherein the probe is configured for insertion into the organ and the detecting component is adapted to collect said plurality of data parameters simultaneously so as to detect in real time correlated changes of the characteristic spectral band of each of the one or more target substances to determine physiological parameters indicative of onset of shock.

2. The system of claim 1, wherein the detection component includes a light delivery conduit for illuminating and collecting return light from a plurality of discrete spectral sources to monitor the spectral characteristics of target substances within the organ.

3. The system of claim 1, wherein the detecting component comprises a plurality of fiber-optics and photo detectors.

4. The system of claim 3, wherein the detecting component further comprises a plurality of laser diodes.

5. The system of claim 1, wherein the detecting component further comprises a temperature sensor.

6. The system of claim 6, wherein the physiological parameters include at least one of organ temperature and organ level of deoxygenated hemoglobin.

7. A device for monitoring at least two physiological parameters associated with an organ, comprising:

a catheter having a proximal end, a tissue-penetrating distal end adapted to be inserted into tissue of the organ, and a housing extending between the proximal end and the distal end, the housing defining a catheter lumen, wherein the catheter is effective to detect temperature at the distal end of the catheter; and

a fiber-optic element extending through the catheter lumen from the proximal end to the distal end of the catheter and being adapted to emit light to the organ tissue and to receive reflected light from the organ tissue, the reflected light being effective to generate data regarding a level of oxygenated hemoglobin associated with the organ.

8. The device of claim 7, further comprising a temperature sensor disposed proximate the distal end of the catheter.

9. A method for assessing the functionality of an organ in real-time, comprising the steps of:

inserting a catheter for collecting data from the organ to a location inside the organ, the catheter having a proximal end, a tissue-penetrating distal end and a housing extending between the proximal end and the distal end, the housing having disposed therein a plurality of fiber-optics and a thermistor for detecting temperature at the distal end of the catheter;

transmitting light to the organ and receiving reflected light from the organ, the light being transmitted along the plurality of fiber-optics and being effective to generate data regarding a level of hemoglobin deoxygenation associated with the organ;

receiving data collected by the catheter, the data reflecting the level of hemoglobin deoxygenation and temperature associated with the organ; and

interpreting the data to generate a real-time indicator of the functionality of the organ.

10. A system for monitoring the function of an organ in a patient, wherein the organ contains one or more target substances, each having a characteristic spectral band, such system comprising:

a probe having a proximal end and a tissue-penetrating distal end adapted to be inserted into the organ; and

a detecting component disposed within the probe for collecting data relating to physiological parameters of the organ, wherein said detecting component includes an optical fiber transmission means for relaying light between the proximal and the distal ends of the catheter, wherein the detecting component determines correlated changes of the characteristic spectral band of each of the one.or more target substances in the organ to provide an effective parameter indicator for the onset of shock.

11. The system of claim 10, wherein the effective parameter indicator includes a spectral parameter indicator of hemoglobin deoxygenation.

12. The system of claim 11, wherein the effective parameter indicator includes a temperature indicator.

13. The system of claim 10, wherein the detecting component is adapted to assess liver function by detecting correlated changes of the characteristic spectral band of each of the one or more target substances associated with liver function, and said effective parameter indicator includes a composite indicator of liver metabolic activity.