MICRO-REMOTE GASTROINTESTINAL PHYSIOLOGICAL MEASUREMENT DEVICE

• US 20080228047A1
• Filed: 01/22/2008
• Published: 09/18/2008
• Est. Priority Date: 01/19/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Sierra Scientific Instruments, Inc.
• Inventors: Parks, Thomas R., Son, Jae S.
• Granted Patent: US 9,125,588 B2
• Time in Patent Office: Days
• US Class Current: 600/302
• CPC Class Codes: A61B 1/00147 Holding or positioning arrangements
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 1/273 for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• 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 5/42 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

Abstract

A physiological sensor-transmitter assembly for measuring a physiological property at an internal body location of a subject over time is described. An instrument for inserting the assembly in the subject and a method of monitoring a physiological property measured at the internal body location over time are also described. The assembly includes a sensor and a transmitter adapted to transmit information from the sensor in a non-wired fashion to a receiver. The assembly also includes an anchor adapted to attach to an externally accessible portion of a subject and a tether that connects the sensor and the anchor to maintain a position of the sensor within the gastrointestinal tract of the subject.

Claims

1. A physiological sensor-transmitter assembly for measuring a value of an internal physiological property at an internal body location of a subject and transmitting information regarding the measured value to a receiver located external to the body of the subject, the assembly comprising:

a sensor adapted to measure a value of a physiological property at an internal body location when the sensor is positioned at the internal body location;

a transmitter coupled to the sensor and adapted to transmit information regarding the measured value to a receiver located external to the body of the subject;

an anchor adapted to attach to an externally accessible portion of the body; and

a tether connecting the anchor disposed at a proximal portion of the tether and the sensor disposed at a distal portion of the tether.

2. The assembly of claim 1, wherein the transmitter is disposed at the distal portion of the assembly.

3. The assembly of claim 1, wherein the transmitter is disposed at the anchor.

4. The assembly of claim 1, wherein a portion of the tether between the anchor and the transmitter has a length adapted to position the transmitter at an oropharynx of the subject.

5. The assembly of claim 1, wherein the tether comprises a signal conductor and the sensor is electrically coupled to the transmitter through the signal conductor.

6. The assembly of claim 1, wherein the transmitter is connected to the sensor through the tether.

7. The assembly of claim 1, further comprising a second sensor for measuring a value of a physiological property at a second internal body location, the second sensor being electrically coupled to the tether.

8. The assembly of claim 7, further comprising a second transmitter electrically coupled to the second sensor.

9. The assembly of claim 1, wherein the tether comprises:

a nasal portion having a nasal portion diameter; and

a esophageal portion having a esophageal portion diameter smaller than the nasal portion diameter.

10. The assembly of claim 9, wherein the esophageal portion diameter is smaller than about 1.0 mm.

11. The assembly of claim 9, wherein the esophageal portion diameter is smaller than about 0.5 mm.

12. The assembly of claim 9, wherein the esophageal portion has an esophageal portion stiffness and the nasal portion has a nasal portion stiffness, the esophageal portion stiffness being greater than the nasal portion stiffness.

13. The assembly of claim 9, wherein the esophageal portion comprises an outer layer of high stiffness.

14. The assembly of claim 13, wherein the nasal portion of the tether comprises a soft elastomeric outer layer.

15. The assembly of claim 1, wherein the sensor is adapted to measure at least one physiological property selected from the group consisting of:

pressure, pH, temperature, and electrical impedance.

16. The assembly of claim 1, wherein the externally accessible portion of the body comprises a body surface within a nasal cavity of the patient or a surface on a face of the subject external to and adjacent to an opening to a gastrointestinal tract of the subject.

17. The assembly of claim 1, wherein the anchor comprises an anchor body adapted to adjust a length of the tether.

18. The assembly of claim 1, wherein the anchor comprises an anchor body adapted to hold the transmitter.

19. The assembly of claim 18, wherein the anchor body is adapted to receive the transmitter and the transmitter is adapted for reuse.

20. The assembly of claim 1, wherein the assembly further comprises an analog to digital converter.

21. The assembly of claim 1, wherein the transmitter comprises a low power radio frequency transmitter.

22. The assembly of claim 1, wherein the assembly further comprises a signal processor coupled between the sensor and the transmitter.

23. An instrument for inserting and positioning a physiological sensor-transmitter assembly having a sensor with a connected tether in an internal location of a body of a subject, the instrument comprising:

an insertion section of the instrument having a diameter suitable for insertion through the nasal-gastric segment of the gastrointestinal tract of the subject;

a deployment section disposed at a distal end portion of the insertion section, the deployment section configured to retain the sensor with the connected tether when the instrument is in a retention state; and

a deployment mechanism adapted to release the sensor from the deployment section in the gastrointestinal tract of the subject upon changing from the retention state to a release state.

24. The instrument of claim 23, further comprising

at least one sensor disposed at the insertion section of the instrument for determining a location of the deployment section within the subject.

25. The instrument of claim 24, wherein the at least one sensor is a pressure sensor fixedly mounted in an exterior wall of the instrument.

26. The instrument of claim 23, further comprising:

a removable outer layer encircling the insertion section of the instrument and the tether of the assembly.

27. The instrument of claim 23, further comprising a temporary retaining device disposed at the deployment section of the instrument adapted to maintain a position of the sensor after deployment as the insertion section of the instrument is withdrawn from the subject.

28. The instrument of claim 27, wherein the temporary retaining device comprises a body of expandable material adapted to expand and separate from the insertion section upon deployment within the subject;

and wherein the expandable material is adapted to dissolve in the subject.

29. The instrument of claim 23, wherein the deployment section has a receptacle sized and dimensioned to hold the sensor.

30. The instrument of claim 29, wherein the deployment mechanism comprises an elongate push element extending from a proximal end of the insertion section to the deployment section, and the push element being slidably coupled to an interior surface of a lumen through the insertion section and being positioned to transmit a force to the sensor to push the sensor out of the receptacle.

31. The instrument of claim 29, wherein the deployment mechanism comprises a fluid conduit extending from a proximal end of the insertion section to the deployment section adapted to conduct a fluid to transmit a fluid force to the sensor to push the sensor out of the receptacle.

32. The instrument of claim 23, wherein the deployment mechanism further comprises:

an inflatable portion of the deployment section having a recess adapted to hold a sensor; and

a fluid conduit extending from a proximal end of the insertion section to the inflatable portion of the deployment section adapted to deliver an inflation fluid to the inflatable portion of the deployment section;

wherein inflating the inflatable portion of the deployment section changes a shape of the recess whereby the sensor is deployed.

33. A method of remotely monitoring a physiological value at a selected location within a body of a subject, the method comprising:

inserting a distal end portion of an instrument through a nasal-gastric segment of a gastrointestinal tract of the subject, the distal end portion having coupled thereto a sensor of a sensor-transmitter assembly comprising;

a transmitter;

an anchor;

a sensor; and

a tether connecting the anchor and the sensor;

advancing the distal end portion of the insertion section along the gastrointestinal tract until the deployment section is positioned at a selected internal body location;

releasing the sensor from the instrument at the selected internal body location;

attaching the anchor to an externally accessible surface of the subject'"'"'s body;

withdrawing the instrument through the nasal-gastric segment of the subject; and

receiving a signal from the transmitter including information regarding a value of a physiological property measured by the sensor at the selected internal body location.

34. The method of claim 33, further comprising loading the assembly into the instrument.

35. The method of claim 33, further comprising determining a location of the deployment section of the instrument from pressure measurements taken by at least one instrument pressure sensor.

36. The method of claim 33, further comprising deploying a temporary restraining element.

37. The method of claim 33, further comprising adjusting a length of the tether between the anchor and the sensor.

38. The method of claim 33, further comprising recording the information received from the transmitter.

39. The method of claim 33, further comprising withdrawing the sensor an connected tether from the subject through the nasal-gastric segment of the subject after receiving the signal for a determined period of time.

40. The method of claim 33, further comprising positioning the transmitter at an oropharynx of the subject.