Implantable monitoring probe

• US 8,323,192 B2
• Filed: 07/22/2004
• Issued: 12/04/2012
• Est. Priority Date: 04/07/1999
• Status: Expired due to Fees

• Current Assignee: Given Imaging Limited (Medtronic Plc)
• Original Assignee: Endonetics, Inc. (Medtronic Plc)
• Inventors: Kilcoyne, John T., Tsukashima, Ross, Johnson, George M., Klecher, Christopher
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US10/896,553
• Publication Number:
  US 20040260164A1
• Time in Patent Office: 3,057 Days
• Field of Search: 600/300, 600/301, 600/350, 600/361, 600/309, 600/549, 604174-176
• US Class Current: 600/309
• CPC Class Codes: A61B 1/00148 using anchoring means
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/6882 Anchoring means

Abstract

Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Claims

1. A medical device for placement within a body lumen of a patient, the device comprising:

a device shell sized for introduction into the body lumen;

a sensor, carried by the device shell, to sense at least one physiological parameter within the body lumen; and

a securing structure mounted to the device shell to secure the device shell relative to a surface within the body lumen, wherein the securing structure is at least partially degradable, wherein said device shell and said sensor are to remain in the body lumen at least until said securing structure is substantially degraded.

2. The medical device of claim 1, wherein the sensor includes at least one of a pH sensor, a temperature sensor, or a pressure sensor.

3. The medical device of claim 1, wherein the securing structure includes a cavity formed in the device shell and a pin to capture luminal tissue within the cavity.

4. The medical device of claim 3, wherein the cavity includes a vacuum port for application of vacuum pressure to draw the tissue into the cavity.

5. The medical device of claim 3, wherein the pin is at least partially formed from a dissolvable or bioabsorbable material and releases the luminal tissue upon substantial dissolution or absorption of the material.

6. The medical device of claim 1, wherein the securing structure includes a pin, hook, barb, clip, suture or staple at least partially formed from a degradable material.

7. The medical device of claim 1, wherein the securing structure includes an adhesive.

8. The medical device of claim 1, wherein the securing structure includes a dissolvable or bioabsorbable material formed at least in part from a material selected from the list consisting of polylactic acid, copolymers of polylactic acid and glycolic acid, polymers of p-dioxanone and 1,4-dioxepan-2-one, and hydroxycarboxylic acids.

9. The medical device of claim 1, wherein the securing structure includes an expandable frame mounted to the device housing and sized to engage an interior wall of the body lumen upon expansion.

10. The medical device of claim 1, wherein the device housing is sized for introduction into an esophagus of the patient, and the securing structure includes an expandable frame mounted to the device housing and sized to engage an interior wall of the esophagus upon expansion.

11. The medical device of claim 10, wherein the expandable frame is formed at least partially from a dissolvable or bioabsorbable material.

12. The medical device of claim 1, further comprising a radio frequency transmitter carried by the device shell to transmit data generated by the sensor.

13. The medical device of claim 1, further comprising a position sensor carried by the device shell to sense an orientation of the device shell.

14. The medical device of claim 1, wherein the securing structure includes a bioabsorbable material.

15. A method for remotely monitoring a physiological parameter in a body lumen of a patient, the method comprising:

introducing into the body lumen a medical device comprising a device shell and carrying a sensor to sense at least one physiological parameter within the body lumen;

securing the medical device relative to a surface within the body lumen with a securing structure mounted to the device shell that is at least partially degradable, wherein said device shell and said sensor are to remain in the body lumen at least until said securing structure is substantially degraded.

16. The method of claim 15, further comprising activating the sensor to sense the physiological parameter.

17. The method of claim 15, wherein the securing structure includes a dissolvable or bioabsorbable material.

18. The method of claim 15, wherein the sensor includes at least one of a pH sensor, a temperature sensor, or a pressure sensor.

19. The method of claim 15, wherein the securing structure includes a cavity formed in the device shell and a pin, and securing the medical device includes advancing the pin within the cavity to capture luminal tissue.

20. The method of claim 19, further comprising applying vacuum pressure to the cavity to draw the tissue into the cavity.

21. The method of claim 19, wherein the pin is at least partially formed from a dissolvable or bioabsorbable material and releases the luminal tissue upon substantial dissolution or absorption of the material.

22. The method of claim 15, wherein the securing structure includes a pin, hook, barb, clip, suture or staple at least partially formed from a degradable material.

23. The method of claim 15, wherein the securing structure includes an adhesive, and wherein securing includes applying the adhesive to the device housing and a wall of the body lumen.

24. The method of claim 15, wherein the securing structure includes a dissolvable or bioabsorbable material formed at least in part from a material selected from the list consisting of polylactic acid, copolymers of polylactic acid and glycolic acid, polymers of p-dioxanone and 1,4-dioxepan-2-one, and hydroxycarboxylic acids.

25. The method of claim 15, wherein the securing structure includes an expandable frame mounted to the device housing, and securing includes expanding the frame to engage an interior wall of the body lumen upon expansion.

26. The method of claim 15, wherein the device housing is sized for introduction into an esophagus of the patient, the securing structure includes an expandable frame mounted to the device housing, and securing includes expanding the frame to engage an interior wall of the esophagus upon expansion.

27. The method of claim 26, wherein the expandable frame is formed at least partially from a dissolvable or bioabsorbable material.

28. The method of claim 15, further comprising activating a radio frequency transmitter in the device shell to transmit data generated by the sensor.

29. A medical device for placement within a body lumen of a patient, the device comprising:

a device shell sized for introduction into the body lumen;

means, carried by the device shell, for sensing at least one physiological parameter within the body lumen; and

means, mounted to the device shell, for securing the device shell relative to a surface within the body lumen, wherein the securing means is at least partially degradable, wherein said device shell and said sensor are to remain in the body lumen at least until said securing structure is substantially degraded.

30. The medical device of claim 29, wherein the sensing means includes means for sensing at least one of pH, a temperature, or pressure sensor.

31. The medical device of claim 29, wherein the securing means includes means for capturing luminal tissue, wherein the capturing means is at least partially formed from a dissolvable or bioabsorbable material and releases the luminal tissue upon substantial dissolution or absorption of the material.

32. The medical device of claim 29, wherein the securing means includes a radial expansion means for engaging an interior wall of the body lumen.