Tissue viability monitor

• US 5,865,738 A
• Filed: 10/21/1994
• Issued: 02/02/1999
• Est. Priority Date: 12/10/1993
• Status: Expired due to Fees

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Nahas, Roger A., Morcos, N. Charle
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US08/327,207
• Time in Patent Office: 1,565 Days
• Field of Search: 128/632, 128/635, 128/664, 128/666, 128/662.06, 607/126, 607/127, 604/49, 604/50, 600/407, 600/309, 600/310, 600/316, 600/342, 600/345, 600/347, 600/365, 600/473, 600/475, 600/479, 600/462
• US Class Current: 600/365
• 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 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

A method and apparatus for evaluating the viability of a tissue of interest, particularly that presents as dead but may be merely stunned or hibernating with reduced or no obvious activity, such as contractility. Dynamic measurement of oxidative metabolism or other metaboic function permits distinguishing between different stages of compromised tissue such as myocardium. Measurements can be made using near-infrared illumination and detection coupled with infusion of one or more metabolic substrates to the region of interest to evaluate whether a metabolic pathway cascade or a trans-membrane ionic potential are intact and thereby provide an indication of the viability of the cell. One preferred instrument includes a catheter having a tip configured to be positioned adjacent to the tissue to be monitored. Optical fibers extend through the catheter to transmit a monitoring light beam from the tip into the tissue, and to receive a cytochrome-redox-response-dependent light beam from the tissue. Needles in the tip releasably anchor the catheter to the tissue and deliver metabolism-stimulating substances. Redox signals representative of cytochrome aa₃ redox responses in the tissue are generated by a spectrometer coupled to the optical fibers. A computer coupled to the spectrometer generates metabolism readings as a function of the redox signals.

Claims

1. A tissue probe for performing a tissue viability evaluation procedure for measuring the viability of a tissue of interest by measuring a regional metabolic process in the absence and presence of an added substance, said tissue probe comprising

a probe means having a proximal and a distal end, said distal end designed to be positioned near a tissue of interest,

a measuring means for measuring a metabolic condition in the tissue of interest, at least part of said measuring means positioned near said distal end of the probe means,

a delivery means connected to said probe means comprising a reservoir of a metabolic substrate having an outlet near the distal end of the probe means.

2. The tissue probe of claim 1 wherein said probe means comprises an elongated catheter with a distal end configured to be positioned adjacent to the tissue to be monitored.

3. The tissue probe of claim 1 wherein said measuring means is selected from the group consisting of optical measuring means, ultrasound measuring means, and biochemical measuring means.

4. The tissue probe of claim 1 wherein said delivery means comprises an elongated member having at least one lumen extending to the distal portion of the probe.

5. The tissue probe of claim 1 wherein said measuring means further comprises optical measuring means.

6. The tissue probe of claim 1 wherein said measuring means comprises

signal generation means for generating a source signal,

signal conduction means for conducting said source signal to the distal end of the probe means, said signal conduction means connected to said signal generation means,

signal transmission means for transmitting said source signal to tissue in the proximity connected to said signal conduction means,

signal receiving means positioned near the distal end of said probe means such that the signal receiving means can be positioned near the tissue of interest.

7. The tissue probe of claim 1 further comprising signal processing means positioned near the proximal end of said probe means and connected to the signal receiving means.

8. A tissue probe for performing a tissue viability evaluation procedure for measuring the viability of a tissue of interest by measuring a regional metabolic process in the absence and presence of an added substance, said tissue probe comprising

a probe means having a proximal and a distal end, said distal end designed to be positioned near a tissue of interest,

a measuring means for measuring a metabolic condition in the tissue of interest, at least part of said measuring means positioned near said distal end of the probe means, and

a first and second delivery means connected to said probe means for independently delivering two metabolic substrates to said tissue of interest near the distal end of the probe means.

9. A monitor for evaluating the viability of a tissue by stimulating changes in the metabolism of the tissue and measuring cytochrome responses representative of changes in the metabolism, comprising

a catheter having proximal and distal ends, and a tip on the distal end configured to be positioned adjacent to a tissue to be monitored,

optical fiber means integrated with the catheter comprising

at least one light-transmitting optical fiber extending through the catheter between the proximal end of the catheter and the tip for transmitting a monitoring light beam from the tip of the catheter into the tissue, and

at least one light-receiving optical fiber extending through the catheter between the proximal end and the tip for receiving a cytochrome redox-response-dependent light beam from the tissue, and

a first delivery means integrated with the catheter for delivering a metabolic substrate to the tissue from the tip,

a source of a metabolic substrate coupled to the first delivery means, and

a cytochrome redox monitor coupled to the optical fiber means.

10. The monitor of claim 9 and further comprising anchor means within the catheter for releasably engaging the tip of the catheter to the tissue.

11. The monitor of claim 9 wherein the first delivery means comprises a first needle.

12. The monitor of claim 11 wherein the first delivery means further comprises a first lumen connected to said first needle and extending to the proximal end of the catheter.

13. The monitor of claim 11 further comprising a needle mounting mechanism for retractably extending said first needle from the distal end of the catheter.

14. The monitor of claim 9 further comprising a second delivery means having a lumen connected to a needle and extending to the proximal end of the catheter.

15. The monitor of claim 14 further comprising at the proximal end of the catheter a supply of a substance connected to said lumen and therethrough connected to said needle.

16. The monitor of claim 15 wherein said supply of said substance comprises a metabolic stimulant suitable for administration through said needle and suitable as a stimulant which can be active in said tissue to be monitored.

17. The monitor of claim 16 wherein the stimulant comprises adenosine diphosphate.

18. The monitor of claim 16 wherein the stimulant comprises a metabolism accelerator.

19. The monitor of claim 18 further comprising a needle mounting mechanism for retractably extending said needle from the distal end of the catheter.

20. The monitor of claim 9 wherein the metabolic substrate comprises a source of oxygen.

21. The monitor of claim 9 wherein the metabolic substrate comprises fumarate.

22. The monitor of claim 9 wherein the metabolic substrate comprises malate.

23. The monitor of claim 9 wherein the metabolic substrate comprises succinate.

24. The monitor of claim 9 wherein the metabolic substrate comprises a metabolism nutrient.

25. A catheter assembly for performing a tissue viability evaluation procedure, including:

a catheter having proximal and distal ends, and a tip on the distal end configured to be positioned adjacent to the tissue to be monitored;

a glucose monitor having a sensor at the distal end of the catheter; and

means within the catheter for delivering a metabolism-stimulating substance and a metabolic substrate to the tissue from the tip, comprising a first delivery means connected to a supply of a metabolic substrate and a second delivery means connected to a supply of a metabolic stimulant.

26. The catheter assembly of claim 25 wherein the metabolic substrate comprises glucose.

27. The catheter assembly of claim 25 wherein the stimulant comprises insulin.