Capsule and method for treating or diagnosing conditions or diseases of the intestinal tract

• US 9,414,768 B2
• Filed: 08/22/2011
• Issued: 08/16/2016
• Est. Priority Date: 06/26/2001
• Status: Active Grant

• Current Assignee: Entrack, Inc.
• Original Assignee: Entrack, Inc.
• Inventors: Imran, Mir A.
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/215,182
• Publication Number:
  US 20110306897A1
• Time in Patent Office: 1,821 Days
• Field of Search: 600/546, 600/547, 600/549, 600/587, 600/593
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• 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 5/14539 : for measuring pH
• CPC Class Codes: A61B 5/1459 : invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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 5/4233 : oesophagus
• CPC Class Codes: A61B 5/4255 : Intestines, colon or appendix
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6873 : Intestine
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37205 : Microstimulators, e.g. implantable through a cannula

Abstract

A device and method for mapping, diagnosing and treating inflammatory disorders (such as Crohn'"'"'s disease) or other diseases, disorders or conditions of the intestinal tract is provided using a capsule passing through the intestinal tract. Further, a capsule tracking system is provided for tracking a capsule'"'"'s location along the length of an intestinal tract as various treatment and/or sensing modalities are employed. In one variation, an acoustic signal is used to determine the location of the capsule. A map of sensed impedance and or temperature may be derived from the pass of a capsule to diagnose the disorder or disease. The capsule or subsequently passed capsules may treat, further diagnose, or mark the intestinal tract at a determined location along its length.

Claims

1. A method for diagnosing an inflammatory gastrointestinal disorder comprising:

providing an autonomous capsule comprising an impedance sensor for implementation within a gastrointestinal tract, wherein the impedance sensor is configured to detect an electrical impedance by providing a voltage across two electrodes of the sensor, the capsule further comprising a deployment mechanism wrapped at least partially around the capsule which is expandable to bring the two electrodes of the impedance sensor into contact with a wall of the gastrointestinal tract to detect the electrical impedance;

sensing, with the impedance sensor, one or more impedances at a first impedance location within the gastrointestinal tract while the capsule is being tracked by providing at least one voltage across the two electrodes at the first impedance location, each at least one voltage having a frequency between 10 kHz and 100 Hz which is different from the other at least one voltages;

sensing, with the impedance sensor, one or more impedances at a second impedance location within the gastrointestinal tract while the capsule is being tracked by providing the at least one voltage across the two electrodes at the second impedance location;

determining, for each voltage of the at least one voltages, whether the sensed impedance at the first impedance location is different from the sensed impedance at the second impedance location by more than a predetermined difference; and

in response to determining, for a voltage of the at least one voltages, that a sensed impedance at the first impedance location is different from a sensed impedance at the second impedance location by more than the predetermined difference, spraying, from the autonomous capsule, a marking agent on the second impedance location, the marking agent to pinpoint the second impedance location for at least one of diagnosis or surgery.

2. The method of claim 1 wherein sensing the one or more impedances by providing the at least one voltage comprises providing three voltages having frequencies of 10 kHZ, 1 kHz and 100 Hz.

3. The method of claim 1, further comprising:

providing, in the autonomous capsule, a temperature sensor;

sensing, with the temperature sensor, a temperature at a first temperature location within the gastrointestinal tract;

sensing, with the temperature sensor, a temperature at a second temperature location within the gastrointestinal tract;

determining whether the temperature at the first temperature location is different from the temperature at the second temperature location by a predetermined difference; and

in response to determining that the temperature at the first temperature location is different from the temperature at the second temperature location, spraying, from the autonomous capsule, a marking agent on the second temperature location, the marking agent to pinpoint the second impedance location for at least one of diagnosis or surgery.

4. The method of claim 3, further comprising:

sensing the impedance at a plurality of impedance locations within the gastrointestinal tract;

mapping the sensed impedance with respect to each of the plurality of impedance locations;

sensing the temperature at a plurality of temperature locations with gastrointestinal tract; and

mapping the sensed temperature with respect to each of the plurality of temperature locations;

wherein one or more locations corresponding to one or more of a temperature anomaly or an impedance anomaly is marked with the marking agent.

5. The method of claim 1, wherein the marking agent includes one or more of a radiopaque marker, a fluorescing compound, or a dye.

6. The method of claim 1, further comprising detecting a gastrointestinal disorder by, in response to determining, for each voltage of the at least one voltages, whether the sensed impedance at the first impedance location is different from the sensed impedance at the second impedance location by more than a predetermined difference:

comparing the sensed impedances on a map by weighing the sensed impedances for lower frequencies more than sensed impedances for higher frequencies.

7. A method for diagnosing a gastrointestinal disorder, comprising:

providing an autonomous capsule comprising an impedance sensor to a patient, the autonomous capsule for implementation within a patient'"'"'s gastrointestinal tract, wherein the impedance sensor is configured to detect an electrical impedance by providing a voltage across two electrodes of the sensor, the capsule further comprising a deployment mechanism wrapped at least partially around the capsule which is expandable to bring the two electrodes of the impedance sensor into contact with a wall of the gastrointestinal tract to detect the electrical impedance;

sensing, with the impedance sensor, one or more impedance values for a first location in the gastrointestinal tract by providing at least one voltage across the two electrodes at the first impedance location, each at least one voltage having a frequency between 10 kHz and 100 Hz which is different from the other at least one voltages;

sensing, with the impedance sensor, one or more second impedance values for a second location in the gastrointestinal tract by providing the at least one voltage across the two electrodes at the second impedance location;

computing, for each voltage of the at least one voltages, an impedance difference between the first impedance value and the second impedance value; and

determining a location of the gastrointestinal disorder by comparing the impedance differences with a first predetermined value; and

in response to determining the location of the gastrointestinal disorder, spraying, from the autonomous capsule, a marking agent on the determined location, the marking agent to pinpoint the determined location for at least one of diagnosis or surgery.

8. The method of claim 7, wherein sensing the one or more impedance values by providing the at least one voltage comprises providing three voltages having frequencies of 10 kHZ, 1 kHz and 100 Hz.

9. The method of claim 7, further comprising:

providing, in the autonomous capsule, a temperature sensor;

sensing, with the temperature sensor, a first temperature value for a first portion of the gastrointestinal tract;

sensing, with the temperature sensor, a second temperature value for a second portion of the gastrointestinal tract; and

computing a temperature difference between the first and second temperature values,

wherein the determination of the location of the gastrointestinal disorder is further based on a second comparison between the temperature difference and a second predetermined value.

10. The method of claim 9, further comprising:

measuring a plurality of temperature values at a plurality of temperature locations within the gastrointestinal tract; and

measuring, for each of the plurality of temperature locations, a distance traveled by the autonomous capsule;

constructing a temperature map of the gastrointestinal tract of the patient based on the measured distances and the measured temperature values with respect to each of the plurality of temperature locations.

11. The method of claim 7, wherein the marking agent includes one or more of a radiopaque marker, a fluorescing compound, or a dye.

12. The method of claim 7, wherein determining the location of the gastrointestinal disorder comprises:

comparing the sensed on a map by weighing the impedances for lower frequencies more than sensed impedances for higher frequencies.