Micro-remote gastrointestinal physiological measurement device

• US 9,125,588 B2
• Filed: 01/22/2008
• Issued: 09/08/2015
• 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.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/018,049
• Publication Number:
  US 20080228047A1
• Time in Patent Office: 2,786 Days
• Field of Search: 606/129, 606/1, 606/108, 600/102, 600/103, 600/104, 600/106, 600/109, 600/156, 604/21, 604/514, 604/59, 604/60, 604/70, 604/72
• US Class Current: 1/1
• 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. An instrument for inserting and positioning a sensor-transmitter assembly in a body of a subject, the instrument comprising:

an insertion section insertable through the nasal-gastric segment of the gastrointestinal tract of a subject;

a deployment section disposed at a distal end portion of the insertion section, the deployment section having therein a lumen shaped receptacle retaining a sensor;

an elongate push rod extending through and slidable in the insertion section to push the sensor out of the lumen shaped receptacle in the gastrointestinal tract of the subject; and

a removable outer sleeve encircling the insertion section and containing a tether connected to the sensor between at least the insertion section and the removable outer sleeve.

2. The instrument of claim 1, 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.

3. The instrument of claim 2, wherein the at least one sensor is a pressure sensor fixedly mounted in an exterior wall of the instrument.

4. The instrument of claim 1, 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.

5. The instrument of claim 4, 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.

6. The instrument of claim 1, wherein:

the removable outer sleeve comprises perforations to aid in removal.

7. The instrument of claim 1, wherein the tether is outside the insertion section.

8. The instrument of claim 1, wherein the deployment section comprises a slit configured to enable the tether, attached to the sensor in the receptacle, to extend from the receptacle to an outer surface of the insertion section.

9. The instrument of claim 1, wherein the insertion section comprises an opening into the deployment section.

10. The instrument of claim 1, wherein a diameter of the insertion section is between 1 and 5 mm.

11. The instrument of claim 1, wherein the tether extends along the length of the insertion section from a location at a first end adjacent the deployment section to a location adjacent an opposing end of the insertion section.

12. An instrument for inserting and positioning a sensor-transmitter assembly in a body of a subject, the instrument comprising:

an insertion section insertable through the nasal-gastric segment of the gastrointestinal tract of a subject;

a deployment section disposed at a distal end portion of the insertion section, the deployment section having therein a lumen shaped receptacle retaining a sensor;

an elongate push rod extending through and slidable in the insertion section to push the sensor out of the lumen shaped receptacle in the gastrointestinal tract of the subject; and

a removable outer sleeve encircling the insertion section and containing a tether connected to the sensor, wherein the tether is outside the insertion section.

13. The instrument of claim 12, wherein:

the removable outer sleeve comprises perforations to aid in removal.

14. The instrument of claim 12, wherein the deployment section comprises a slit configured to enable the tether, attached to the sensor in the receptacle, to extend from the receptacle to an outer surface of the insertion section.

15. The instrument of claim 12, wherein the insertion section comprises an opening into the deployment section.

16. The instrument of claim 12, wherein a diameter of the insertion section is between 1 and 5 mm.

17. The instrument of claim 12, wherein the tether extends along the length of the insertion section from a location at a first end adjacent the deployment section to a location adjacent an opposing end of the insertion section.

18. The instrument of claim 12, wherein the tether comprises an electrically conductive member.

19. The instrument of claim 18, further comprising:

a transmitter connected to the sensor through the tether and adapted to transmit information regarding a value measured with the sensor to a receiver located external to the body of the subject.