Using an oximeter probe to detect intestinal ischemia

• US 10,368,749 B1
• Filed: 08/22/2017
• Issued: 08/06/2019
• 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:
  US15/683,730
• Time in Patent Office: 714 Days
• Field of Search: 600310, 600339, 600323, 600317, 600324
• 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:

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

through the opening, contacting a sensor probe of an oximetry device to a serosal surface of the serosal tissue of the intestinal or mesentery tissue;

determining, by the oximetry device, a signal quality factor for contact of the sensor probe of the oximetry device to the serosal surface of the serosal tissue of the intestinal or mesentery tissue;

measuring, via the oximetry device, whether the signal quality factor for contact of the sensor probe of the oximetry device to the serosal surface of the serosal tissue of the intestinal or mesentery tissue is within a range that indicates at least threshold contact;

when the signal quality factor is within the range that indicates at least threshold contact, measuring oxygen saturation of the serosal tissue of the intestinal or mesentery tissue, via the oximetry device during the temporary ischemic period, from contacting of the serosal surface of the serosal tissue of the intestinal or mesentery tissue with the sensor probe;

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

diagnosing, via the oximetry device, 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 measuring oxygen saturation of the tissue during the temporary ischemic period comprises:

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

a hollow needle; and

the sensor probe comprising the one or more optical fibers, wherein distal ends of the one or more optical fibers are located at a tip of the sensor probe forming an oximeter sensor, and the sensor probe is disposed inside the hollow needle; and

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

determining intensity changes of collected light that is collected by the one or more optical fibers from the intestinal or mesentery tissue for the temporary ischemic period for measuring the oxygen saturation.

3. The method of claim 1 comprising:

introducing into the abdominal cavity, through a trocar that is punctured through the outer tissue, a needle sensor device comprising a hollow needle and the sensor probe, the sensor probe comprising a first optical fiber wherein a distal end of the first optical fiber is located at a tip of the sensor probe forming an oximeter sensor of the oximetry device;

transmitting a first light, having a wavelength between about 600 nanometers to about 900 nanometers into the serosal surface of the serosal tissue of the intestinal or mesentery tissue through the first optical fiber at the tip of the sensor probe;

receiving a second light reflected from the tissue through the first optical fiber at the tip of the sensor probe; and

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

4. A method comprising:

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

introducing into the abdominal cavity, through a trocar that is punctured through the outer tissue, a needle sensor device comprising a hollow needle and the sensor probe, the sensor probe comprising a first optical fiber wherein a distal end of the first optical fiber is located at a tip of the sensor probe forming an oximeter sensor of the oximetry device;

through the opening, contacting a sensor probe of an oximetry device to a serosal surface of the serosal tissue of the intestinal or mesentery tissue comprising;

contacting the serosal surface of the serosal tissue of the intestinal or mesentery tissue with the first optical fiber of the sensor probe,

determining the oxygen saturation value, via the oximetry device, for the tissue comprises;

during the temporary ischemic period, transmitting a first light from a second optical fiber of the sensor probe to the first optical fiber;

during the temporary ischemic period, transmitting the first light into the serosal surface of the serosal tissue of the intestinal or mesentery tissue through the first optical fiber at the tip of the sensor probe; and

during the temporary ischemic, collecting reflected radiation from the contacted serosal surface of the serosal tissue of the intestinal or mesentery tissue via the first optical fiber of the sensor probe;

determining, by the oximetry device, a signal quality factor for contact of the sensor probe of the oximetry device to the serosal surface of the serosal tissue of the intestinal or mesentery tissue;

measuring, via the oximetry device, whether the signal quality factor for contact of the sensor probe of the oximetry device to the serosal surface of the serosal tissue of the intestinal or mesentery tissue is within a range that indicates at least threshold contact;

when the signal quality factor is within the range that indicates at least threshold contact, measuring oxygen saturation of the serosal tissue of the intestinal or mesentery tissue, via the oximetry device during the temporary ischemic period, from contacting of the serosal surface of the serosal tissue of the intestinal or mesentery tissue with the sensor probe;

using a processor, analyzing, via the oximetry device, the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period comprising;

transmitting the first light, having a wavelength between about 600 nanometers to about 900 nanometers into the serosal surface of the serosal tissue of the intestinal or mesentery tissue through the first optical fiber at the tip of the sensor probe;

receiving a second light reflected from the tissue through the first optical fiber at the tip of the sensor probe,

wherein receiving the second light reflected from the tissue through the first optical fiber at the tip of the sensor probe comprises, during the temporary ischemic, transmitting the reflected radiation from the first optical fiber of the sensor probe to a third optical fiber of the sensor probe, and

determining an oxygen saturation value, via the oximetry device, for the tissue based on values for the first and second light;

analyzing, via the oximetry device, the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period comprises analyzing, via the oximetry device, the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue 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.

5. The method of claim 4 wherein a separating bar is positioned between the second and third optical fibers in a hole is formed in the first end of the first optical fiber.

6. A system for diagnosing an intestinal ischemia, comprising:

a device to induce a temporary ischemic period, through an opening in an abdominal wall of a patient to access an abdominal cavity of the patient, in serosal tissue of an intestinal or mesentery tissue, which is in the abdominal cavity, by using a device that constricts a mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue;

a sensor probe comprising a first optical fiber, a second optical fiber, and a third optical fiber, wherein the first optical fiber is adapted to deliver radiation to the second optical fiber, the second optical fiber is adapted to contact the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period of the serosal tissue for emitting the radiation into the contacted serosal tissue and to detect reflected radiation from the contacted serosal tissue, the third optical fiber is adapted to receive the reflected radiation from the second optical fiber, and based on the reflected radiation received in the third optical fiber from the second optical fiber, measure oxygen saturation, via the device, of the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period of the serosal tissue; and

a system unit including a processor, coupled to the sensor probe, which analyzes oxygen saturation in the serosal tissue of the intestinal or mesentery tissue during the temporary ischemic period and diagnoses, via the device, the patient as having intestinal ischemia according to the oxygen saturation in the intestinal or mesentery tissue during the temporary ischemic period.

7. The system of claim 6 wherein the system unit comprises a processor.

8. The system of claim 6 wherein the system unit comprises a signal emitter.

9. The system of claim 6 wherein the system unit comprises a signal detector.

10. The system of claim 6 wherein the system unit comprises a signal emitter, coupled to the first optical fiber, and a signal detector, coupled to the third optical fiber.

11. The system of claim 6 wherein the sensor probe comprises a first connector portion and the system unit comprises a second connector portion, and the first and second connector portions mate which each other to removably couple the sensor probe and the system unit together.

12. The system of claim 6 wherein the sensor probe comprises haptic technology.

13. The system of claim 6 wherein the system unit comprises a rechargeable battery and a recharging circuit comprising an AC-to-DC power converter.

14. The system of claim 6 wherein the sensor probe comprises graduated markings on its exterior.

15. A method comprising:

through an opening in an abdominal wall of a patient to access serosal tissue of an intestinal or mesentery tissue that is located in an abdominal cavity of the patient, inducing, via a constriction device, a temporary ischemic period of serosal tissue of intestinal or mesentery tissue of the patient by using the constriction device to constrict a mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue;

through an opening in an abdominal wall, removing, via the constriction device, a constriction of the mesenteric artery that supplies blood to the serosal tissue of the intestinal or mesentery tissue to induce a recovery from the temporary ischemic period;

through an opening in an abdominal wall, contacting, via an oximetry device, a serosal surface of the serosal tissue with a first optical fiber of a sensor probe of the oximetry device;

transmitting radiation from a second optical fiber of the sensor probe to the first optical fiber;

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

collecting reflected radiation from the serosal surface of the serosal tissue via the first optical fiber;

transmitting the reflected radiation from the first optical fiber to a third optical fiber of the sensor probe;

measuring, via the oximetry device, oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during the recovery from the temporary ischemic period, after removing the constriction to the mesenteric artery, based on the reflected radiation received in the third optical fiber;

analyzing, via the oximetry device, the oxygen saturation of the serosal tissue of the intestinal or mesentery tissue during recovery from the temporary ischemic period; and

diagnosing, via the oximetry device, 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 recovery from the temporary ischemic period.

16. The method of claim 15 wherein the temporary ischemic period is induced by clipping or adding pressure on the mesenteric artery.

17. The method of claim 15 comprising:

puncturing the abdominal wall with a needle sensor device comprising a hollow needle and the sensor probe, wherein a distal end of the first optical fiber is located at a tip of the sensor probe forming an oximeter sensor.