Using an oximeter probe to detect intestinal ischemia

• US 9,737,213 B1
• Filed: 03/24/2009
• Issued: 08/22/2017
• 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): Towa, Rene
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US12/410,155
• Time in Patent Office: 3,073 Days
• Field of Search: 600322, 600310, 600476, 600323, 600317, 600324, 600339, 600481, 606 34, 3310, 3317, 3323, 3324, 3339, 3481
• 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 for measuring oxygen saturation of serosal tissue comprising:

through an opening created in an outer tissue of the abdominal cavity of a patient, inducing a temporary ischemic period for serosal tissue of an intestinal or mesentery tissue of a patient by using a device that constricts a mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue;

through the opening, contacting a serosal surface of the serosal tissue of the intestinal or mesentery tissue with a first optical fiber;

Transmitting radiation from a second optical fiber to the first optical fiber;

emitting the radiation from the first optical fiber into the serosal surface of the serosal tissue of the intestinal or mesentery tissue;

collecting reflected radiation from the serosal surface of the serosal tissue of the intestinal or mesentery tissue with the first optical fiber;

transmitting the reflected radiation from the first optical fiber to a third optical fiber, wherein the reflected radiation is received by a light detector;

through the opening, measuring oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period from the contacting of the serosal surface of the serosal tissue of the intestinal or mesentery tissue;

using a processor, analyzing the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period based on the radiation received in the third optical fiber; and

diagnosing the patient as having intestinal ischemia according to changes in the oxygen saturation in the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period.

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

3. The method of claim 1 wherein the analyzing the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue comprises calculating a rate of change of oxygen saturation during the temporary ischemic period.

4. The method of claim 3 wherein the patient is diagnosed as having intestinal ischemia if the rate of change of oxygen saturation is less than a threshold.

5. The method of claim 1 wherein the analyzing the oxygen saturation comprises calculating a reduction in oxygen saturation of the serosal tissue of the intestinal or mesentery tissue at a specific time point during the temporary ischemic period.

6. The method of claim 1 wherein the measuring oxygen saturation of the tissue during the temporary ischemic period comprises:

directing light from one or more of the optical fibers of a trocar into the intestinal or the mesentery tissue, wherein the trocar comprises;

a hollow needle; and

a sensor probe comprising one or more of the optical fibers wherein distal ends of one or more of the optical fibers are located at a tip of the sensor probe forming an oximeter sensor, and

wherein the sensor probe is disposed inside the hollow needle; and

collecting light by one or more of the optical fibers from the intestinal or the mesentery tissue, wherein the analyzing the oxygen saturation of the tissue during the temporary ischemic period comprises;

determining intensity changes of the collected light for the intestinal or mesentery tissue from the temporary ischemic period for measuring the oxygen saturation.

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

8. The method of claim 6 wherein one or more of the optical fibers is configured to measure an oxygen saturation value from a full thickness of an intestinal wall tissue.

9. The method of claim 6 wherein the distal end of the first optical fiber has a diameter of about 0.1 millimeters to about 2 millimeters or less.

10. The method of claim 1 comprising:

puncturing an outer tissue with a trocar;

introducing into an abdominal cavity, through the trocar, a needle sensor device comprising a hollow needle and the sensor probe, the sensor probe comprising one or more of the optical fibers wherein distal ends of one or more of the optical fibers are located at a tip of the sensor probe forming an oximeter sensor;

contacting an intestinal or mesentery tissue with the tip of the sensor probe;

transmitting a first light, having a wavelength between about 600 nanometers to about 900 nanometers into the tissue through one or more of the optical fibers at the tip of the sensor probe;

receiving a second light reflected from the tissue through one or more of the optical fibers at the tip of the sensor probe; and

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

11. The method of claim 1 wherein analyzing the oxygen saturation of the serosal tissue comprises calculating a rate of change of oxygen saturation during the recovery and diagnosing the patient as having intestinal ischemia if the rate of change of oxygen saturation is less than a threshold.

12. The method of claim 1 wherein analyzing the oxygen saturation comprises calculating a time for oxygen saturation to recover a specified percentage during the recovery and diagnosing the patient as having intestinal ischemia if the time is greater than a threshold time.

13. A method for measuring oxygen saturation of serosal tissue comprising:

through an opening created in an outer tissue of the abdominal cavity of a patient, inducing a temporary ischemic period for serosal tissue of an intestinal or mesentery tissue of a patient by using a device to constrict a mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue;

through the opening, contacting a serosal surface of the serosal tissue of the intestinal or mesentery tissue;

through the opening, measuring oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period from the contacting of the serosal surface of the serosal tissue of the intestinal or mesentery tissue;

using a processor, analyzing the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period; and

diagnosing the patient as having intestinal ischemia according to changes in the oxygen saturation in the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period,

wherein contacting a sensor probe of an oximetry device to the serosal surface of the serosal tissue of the intestinal or mesentery tissue comprises contacting the serosal surface of the serosal tissue of the intestinal or mesentery tissue with a first optical fiber of the sensor probe, and wherein using the processor, analyzing the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue comprises;

transmitting radiation from a second optical fiber of the sensor probe to the first optical fiber, wherein the radiation is emitted from a light source;

emitting the radiation from the first optical fiber of the sensor probe into the serosal surface of the serosal tissue of the intestinal or mesentery tissue;

collecting reflected radiation from the serosal surface of the serosal tissue of the intestinal or mesentery tissue via the first optical fiber of the sensor probe; and

transmitting the reflected radiation from the first optical fiber of the sensor probe to a third optical fiber of the sensor probe, wherein the reflected radiation is received by a light detector.

14. The method of claim 13 wherein a separating bar is positioned between the second and third optical fibers.