System for determining the viability of tissue

• US 5,722,419 A
• Filed: 11/30/1994
• Issued: 03/03/1998
• Est. Priority Date: 11/30/1994
• Status: Expired due to Fees

• Current Assignee: John L. Semmlow, Robert E. Brolin
• Original Assignee: John L. Semmlow, Robert E. Brolin
• Inventors: Semmlow, John L., Brolin, Robert E.
• Primary Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/347,562
• Time in Patent Office: 1,189 Days
• Field of Search: 607/7, 607/11, 607/48, 607/40, 607/52, 607/33, 128/642-644, 128/733, 128/782, 128/741, 128/780
• US Class Current: 600/546
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• 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: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/6873 Intestine
• CPC Class Codes: A61B 5/6884 Clamps or clips
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14

Abstract

When human intestine becomes damaged due to insufficient blood perfusion (ischemic disease), the damaged tissue must be surgically removed and the remaining tissue sewn together (end-to-end anastomoses). If nonviable tissue is not removed the result can be fatal while removal of too much bowel can also lead to severe complication. The distinction between viable and nonviable tissue must often hastily be made during urgent operations on critically ill patients. This decision remains a challenge for even the most experienced general surgeon. The system disclosed herein is a medical instrument designed to quantify the survivability of intestine compromised by ischemic disease. This medical instrument evaluates ischemic tissue through the quantification of electrical and contractile activity. The computer-based instrument uses advanced signal processing techniques to remove measurement artifact and physiological variability. It provides the surgeon with immediate information that is useful in predicting long-term bowel viability allowing him to remove (resect) an optimal segment of bowel.

Claims

1. A medical instrument which quantifies the survivability of tissue, said medical instrument comprising:

a measurement probe having gripping means for gripping tissue, stimulus electrodes for delivering an electrical stimulus, means for sensing movement in tissue gripped by said measurement probe in response to said electrical stimulus, and measurement electrodes for sensing electromyographic activity in tissue gripped by said measurement probe, wherein said stimulus electrodes, said measurement electrodes, and said tissue movement sensing means are mounted on said gripping means;

control means for controlling the generation of said electrical stimulus, for recording and analyzing movement sensed by said tissue movement sensing means and electromyographic activity sensed by said measurement electrodes, and for generating at least one quantity which is representative of the survivability of the tissue as indicated by at least one of the sensed tissue movement and the sensed electromyographic activity; and

circuit means for electrically connecting said measurement probe with said control means and processing electrical signals representing said electrical stimulus, said electromyographic activity, and said tissue movement.

2. The medical instrument defined in claim 1, further comprising means for sensing movement of said measurement probe.

3. The medical instrument defined in claim 1, wherein said measurement probe includes said means for sensing movement of said measurement probe, wherein said control means records and analyzes movement sensed by said probe movement sensing means, and wherein said circuit means processes at least one electrical signal representing said probe movement.

4. The medical instrument defined in claim 3, wherein said control means the movement sensed by said probe movement sensing means out of the movement sensed by said means for sensing movement in tissue gripped by said measurement probe in response to said electrical stimulus with a noise cancellation weighted subtraction procedure thereby providing a rectified, noise canceled contractile response.

5. The medical instrument defined in claim 4, wherein said control means calculates a difference between the rectified, noise canceled contractile response and a recorded normal contractile response with a weighted subtraction procedure.

6. The medical instrument defined in claim 5, wherein said control means calculates a root mean square of the difference thereby generating a number which quantifies the survivability of the tissue gripped by said measurement probe.

7. The medical instrument defined in claim 1, wherein said gripping means further comprises a clamp for gripping tissue.

8. The medical instrument defined in claim 7, wherein said clamp comprises a rigid support member and a flexible support member, wherein said rigid support member and said flexible support member are biased against each other so as to allow tissue movement to be gripped therebetween, and wherein said tissue sensing means comprises means for sensing bending in said flexible support member.

9. The medical instrument defined in claim 8, wherein said tissue movement sensing means is a strain gauge movement transducer.

10. The medical instrument defined in claim 7, wherein said clamp comprises a pair of rigid support members, wherein said rigid support members are biased against each other so as to allow tissue to be gripped therebetween, and wherein said tissue movement sensing means comprises means for sensing pressure applied against said rigid support members.

11. The medical instrument defined in claim 10, wherein said tissue movement sensing means comprises a flexible fluid filled membrane and a pressure transducer, wherein both said flexible fluid filled membrane and said pressure transducer are mounted on one of said rigid support members, and wherein said pressure transducer senses changes in pressure in said flexible fluid filled membrane.

12. The medical instrument defined in claim 1, wherein said control means calculates a root mean square of the electromyographic activity over a selected time interval, thereby generating a number which quantifies the survivability of the tissue gripped by said measurement probe.

13. The medical instrument defined in claim 1, wherein said control means filters out a slow wave component or spike from the electromyographic activity, thereby producing a de-spiked EMG signal.

14. The medical instrument defined in claim 13, wherein said control means filters out one or more frequency components from the de-spiked EMG signal.

15. The medical instrument defined in claim 14, wherein said control means calculates a root mean square of the frequency-filtered, de-spiked EMG signal, thereby generating a number which quantifies the survivability of the tissue gripped by said measurement probe.

16. A medical instrument which quantifies the survivability of tissue, said medical instrument comprising:

a measurement probe having gripping means for gripping tissue, stimulus electrodes for delivering an electrical stimulus, means for sensing movement in tissue gripped by said measurement probe in response to said electrical stimulus, and measurement electrodes for sensing electromyographic activity in tissue gripped by said measurement probe, wherein said stimulus electrodes, said measurement electrodes, and said tissue movement sensing means are mounted on said gripping means; and

control means for controlling the generation of said electrical stimulus, for recording and analyzing movement sensed by said tissue movement sensing means and electromyographic activity sensed by said measurement electrodes, and for generating at least one quantity which is representative of the survivability of the tissue as indicated by at least one of the sensed tissue movement and the sensed electromyographic activity.

17. The medical instrument defined in claim 16, further comprising means for sensing movement of said measurement probe.

18. The medical instrument defined in claim 16, wherein said measurement probe includes said means for sensing movement of said measurement probe, and wherein said control means records and analyzes movement sensed by said probe movement sensing means.

19. The medical instrument defined in claim 18, wherein said control means filters the movement sensed by said probe movement sensing means out of the movement sensed by said means for sensing movement in tissue gripped by said measurement probe in response to said electrical stimulus with a noise cancellation weighted subtraction procedure thereby providing a rectified, noise canceled contractile response.

20. The medical instrument defined in claim 19, wherein said control means calculates a difference between the rectified, noise canceled contractile response and a recorded normal contractile response with a weighted subtraction procedure.

21. The medical instrument defined in claim 20, wherein said control means calculates a root mean square of the difference thereby generating a number which quantifies the survivability of the tissue gripped by said measurement probe.

22. The medical instrument defined in claim 16, wherein said gripping means further comprises a clamp for gripping tissue.

23. The medical instrument defined in claim 22, wherein said clamp comprises a rigid support member and a flexible support member, wherein said rigid support member and said flexible support member are biased against each other so as to allow tissue to be gripped therebetween, and wherein said tissue movement sensing means comprises means for sensing bending in said flexible support member.

24. The medical instrument defined in claim 23, wherein said tissue movement sensing means is a strain gauge movement transducer.

25. The medical instrument defined in claim 22, wherein said clamp comprises a pair of rigid support members, wherein said rigid support members are biased against each other so as to allow tissue to be gripped therebetween, and wherein said tissue movement sensing means comprises means for sensing pressure applied against said rigid support members.

26. The medical instrument defined in claim 25, wherein said tissue movement sensing means comprises a flexible fluid filled membrane and a pressure transducer, wherein both said flexible fluid filled membrane and said pressure transducer are mounted on one of said rigid support members, and wherein said pressure transducer senses changes in pressure in said flexible fluid filled membrane.

27. The medical instrument defined in claim 16, wherein said control means calculates a root mean square of the electromyographic activity over a selected time interval, thereby generating a number which quantifies the survivability of the tissue gripped by said measurement probe.

28. The medical instrument defined in claim 16, wherein said control means filters out a slow wave component or spike from the electromyographic activity, thereby producing a de-spiked EMG signal.

29. The medical instrument defined in claim 28, wherein said control means filters out one or more frequency components from the de-spiked EMG signal.

30. The medical instrument defined in claim 29, wherein said control means calculates a root mean square of the frequency-filtered, de-spiked EMG signal, thereby generating a number which quantifies the survivability of the tissue gripped by said measurement probe.