Using an oximeter probe to detect intestinal ischemia

• US 10,335,070 B1
• Filed: 07/29/2016
• Issued: 07/02/2019
• Est. Priority Date: 03/24/2009
• Status: Active Grant

• Current Assignee: ViOptix, Inc.
• Original Assignee: ViOptix, Inc.
• Inventors: Heaton, II, Larry C., Lash, Robert E., Mao, Jimmy Jian-min
• Primary Examiner(s): Abouelela, May A
• Application Number:
  US15/223,788
• Time in Patent Office: 1,068 Days
• Field of Search: 600310, 600317, 600323, 600324, 600339, 600481
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/0638 providing two or more wavelengths
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0095 by applying light and detecting acoustic waves, i.e. photoacoustic measurements
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

Devices and systems have a sensor probe configured to measure tissue oxygen saturation in the intestine or mesentery. The devices and systems can determine the oxygenation state of the entire thickness of the intestine or mesentery. Embodiments of the invention also include methods for inducing a temporary ischemic period in an intestine or mesentery tissue and analyzing changes in oxygen saturation of the tissue during the temporary ischemic period or during a recovery phase. The devices, systems, and methods can be applied in diagnosing intestinal ischemia in a patient, as well as in monitoring tissue oxygen saturation of the intestine or mesentery during or after a surgical procedure.

Claims

1. A method comprising:

providing a sensor probe comprising a first optical fiber, wherein the sensor probe is adapted to contact a serosal surface of a serosal tissue of an intestinal or mesentery tissue of a patient during a recovery from a temporary ischemic period, wherein the sensor probe is part of a needle sensor device comprising;

a hollow needle; and

the sensor probe, wherein distal ends of optical fibers are located at a tip of the sensor probe forming an oximeter sensor, and the sensor probe in a first mode, is disposed inside the hollow needle and, in a second mode, the sensor probe is extended past a distal end of the hollow needle to contact the serosal surface of the serosal tissue;

transmitting radiation into the first optical fiber;

emitting the radiation inside a body of the patient from the first optical fiber into the contacted serosal surface of the serosal tissue;

collecting reflected radiation from the contacted serosal surface of the serosal tissue by using a second optical fiber of the sensor probe;

by an electronic processor, using the collected reflected radiation from the second optical fiber to determine a rate of change of oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the recovery from the temporary ischemic period, after removing a constriction to a mesenteric artery; and

using the electronic processor, diagnosing the patient as having intestinal ischemia according to the rate of change of oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the recovery from the temporary ischemic period.

2. The method of claim 1 comprising:

inducing the temporary ischemic period for serosal tissue of the intestinal or mesentery tissue of the patient by constricting the mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue; and

removing the constriction of the mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue to induce the recovery from the temporary ischemic period.

3. The method of claim 1 wherein the temporary ischemic period is induced by clipping or adding pressure on the mesenteric artery.

4. The method of claim 1 wherein the patient is diagnosed as having intestinal ischemia when the rate of change of oxygen saturation is less than a threshold.

5. The method of claim 1 comprising:

providing the needle sensor device, adapted to puncture an outer tissue, wherein the needle sensor comprises the hollow needle and the sensor probe, distal ends of the optical fibers are located at a tip of the sensor probe to form an oximeter sensor,

the tip of the sensor probe is placed in contact with the intestinal or mesentery tissue,

through the first optical fiber at the tip of the sensor probe, a first light, having a wavelength between 600 nanometers to 900 nanometers, is transmitted into the tissue,

a second light reflected from the tissue is received through the second optical fiber at the tip of the sensor probe, and

an oxygen saturation value for the tissue is determined based on values for the first and second light.

6. The method of claim 1 wherein the sensor probe is configured to slide in and out of the hollow needle.

7. The method of claim 6 wherein the first and second optical fibers are separated by a predetermined distance so that the sensor probe is configured to measure oxygen saturation value of a thickness of an intestinal wall tissue.

8. The method of claim 6 wherein the first and second optical fibers are separated by a distance of 2 millimeters or less.

9. The method of claim 6 wherein reflected radiation from the contacted serosal surface of the serosal tissue comprises attenuation compared to the emitted radiation into the serosal tissue due to absorption by chromophores in the tissue.

10. The method of claim 6 wherein reflected radiation from the contacted serosal surface of the serosal tissue comprises attenuation compared to the emitted radiation into the serosal tissue due to absorption by hemoglobin in the tissue.

11. The method of claim 6 wherein the sensor probe comprises a marking mechanism having a marker to mark the serosal tissue of the intestinal or the mesentery tissue after a measurement has been made.

12. The method for claim 6 wherein the sensor probe is adapted to be introduced into the body via a mouth of the patient.

13. The method for claim 6 wherein the sensor probe is adapted to be introduced into the body via an anus of the patient.

14. The method of claim 5 wherein the needle sensor device comprises stainless steel.

15. The method of claim 5 wherein the needle sensor device comprises a diameter of 4 millimeters or less.

16. The method of claim 5 wherein the first light comprises a wavelength of at least 690 nanometers.

17. The method of claim 5 wherein the first light comprises a wavelength of at least 830 nanometers.

18. The method of claim 6 wherein the patient is diagnosed as having intestinal ischemia when the rate of change of oxygen saturation of the serosal tissue comprises a threshold rate of 20 percent oxygen saturation change per minute or less.

19. The method of claim 6 wherein the patient is diagnosed as having intestinal ischemia when the rate of change of oxygen saturation of the serosal tissue comprises a threshold rate of 40 percent oxygen saturation change per minute or less.

20. A method comprising:

providing a trocar including a pointed end and a hollow area, wherein the trocar is adapted to pierce a first tissue of an abdomen of a patient with the pointed end and the hollow area includes a hollow needle with a sensor probe,

wherein the sensor probe comprises a first optical fiber and is adapted to contact a second tissue, different than the first tissue, including a serosal surface of a serosal tissue of an intestinal or mesentery tissue during a recovery from a temporary ischemic period and distal ends of optical fibers are located at a tip of the sensor probe forming an oximeter sensor, and the sensor probe in a first mode, is disposed inside the hollow needle and, in a second mode, is extended past a beveled edge of the hollow needle to slide the sensor probe to contact the serosal surface of the serosal tissue;

transmitting radiation into the first optical fiber;

emitting the radiation inside a body of the patient from the first optical fiber into the contacted serosal surface of the serosal tissue;

collecting reflected radiation from the contacted serosal surface of the serosal tissue using a second optical fiber of the sensor probe;

by an electronic processor, using the collected reflected radiation from the second optical fiber to determine a rate of change of oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the recovery from the temporary ischemic period, after removing a constriction to a mesenteric artery; and

using the electronic processor, diagnosing the patient as having intestinal ischemia according to the rate of change of oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the recovery from the temporary ischemic period.