Implantable monitoring probe

• US 6,689,056 B1
• Filed: 04/06/2000
• Issued: 02/10/2004
• Est. Priority Date: 04/07/1999
• Status: Expired due to Term

• Current Assignee: Given Imaging Limited (Medtronic Plc)
• Original Assignee: Medtronic Endonetics, Inc.
• Inventors: Tsukashima, Ross, Kilcoyne, John T., Johnson, George M., Klecher, Christopher
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): McCrosky, David J.
• Application Number:
  US09/544,373
• Time in Patent Office: 1,405 Days
• Field of Search: 600/300-302, 600/309, 128/897-899, 606/139, 606/140, 606/144, 623/11.11, 623/23.75
• US Class Current: 600/300
• 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 5/14532 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 5/4211 Diagnosing or evaluating reflux
• CPC Class Codes: A61B 5/4233 oesophagus
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: Y10S 128/903 Radio telemetry

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 method of attaching a device to a tissue surface inside of a patient, comprising the steps of:

providing a device having a housing, a concavity on the housing, a window to permit visualization through the housing of the interior of the concavity, and a pin that is axially movable from a retracted position within the housing to an extended position that extends at least part way across the concavity;

carrying the device on an introduction instrument into the body;

positioning the device at an attachment site in the body such that the concavity is adjacent the tissue surface at the attachment site;

drawing tissue into the concavity;

advancing the pin through the tissue to retain the device at the attachment site, and

withdrawing the introduction instrument from the body leaving the pin at the attachment site.

2. A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the device further comprises a lumen in communication with the concavity, and the drawing tissue into the concavity step additionally comprises the step of applying suction to the lumen.

3. A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the window comprises a transparent wall on the housing, and said visualizing tissue step comprises observing tissue through the wall of the housing.

4. A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the carrying the device on an introduction instrument step comprises carrying the device by an endoscope.

5. A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the pin comprises a material that degrades at the attachment site, and the method further comprises the step of permitting the pin to degrade, thereby releasing the device from the tissue surface.

6. A method of attaching a device to a tissue surface inside of a patient, comprising the steps of:

providing a device having a housing, a concavity on the housing, and a pin that is axially movable from a retracted position within the housing to an extended position that extends at least part way across the concavity;

carrying the device on an introduction instrument into the body;

positioning the device at an attachment site in the body such that the concavity is adjacent the tissue surface at the attachment site;

drawing tissue into the concavity;

advancing the pin through the tissue to retain the device at the attachment site; and

withdrawing the introduction instrument from the body, leaving the pin at the attachment site.

7. A method of attaching a device to a tissue surface inside of a patient as in claim 6, wherein the device further comprises a lumen in communication with the concavity, and the drawing tissue into the concavity step additionally comprises the step of applying suction to the lumen.

8. A method of attaching a device to a tissue surface inside of a patient as in claim 6, wherein the carrying the device on an introduction instrument step comprises carrying the device on an endoscope.

9. A method of attaching a device to a tissue surface inside of a patient as in claim 6, wherein the pin comprises a material which degrades at the attachment site, and the method further comprises the step of permitting the pin to degrade, thereby releasing the device from the tissue surface.

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

providing a device having a housing, a physiological parameter detector in the housing, a concavity on the housing, and a pin that is axially movable from a retracted position within the housing to an extended position that extends at least part way across the concavity;

carrying the device on an introduction instrument into the body;

positioning the device at an attachment site in the body such that the concavity is adjacent the tissue surface at the attachment site;

drawing tissue into the concavity;

advancing the pin through the tissue to retain the device at the attachment site;

sensing at least one physiological parameter; and

withdrawing the introduction instrument from the body, leaving the pin at the attachment site.

11. A method as in claim 10, wherein the attachment site is the surface of the esophagus.

12. A method as in claim 10, wherein the device further comprises a radiofrequency transmitter, and said physiological parameter data transduced by the detector is transmitted to a radiofrequency receiver and a recording device located outside the patient'"'"'s body.

13. A method as in claim 10, wherein the device further comprises a microprocessor.

14. A method as in claim 10, wherein the device further comprises a digita recorder that records physiological parameter data.

15. A method as in claim 14, further comprising the step of transferring the physiological parameter data from the digital recorder to an external data retrieval device.

16. A method as in claim 10, wherein the physiological parameter is selected from the group consisting of pH, temperature, and pressure.

17. A method as in claim 16, wherein the physiological parameter data comprises data concerning at least two of said parameters.

18. A method as in claim 16, wherein the physiological parameter data comprises data concerning all three of said parameters.

19. A method as in claim 10, wherein the physiological parameter comprises the concentration of ions within a body fluid.

20. A method as in claim 19, wherein the ions are selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate.

21. A method as in claim 10, wherein the physiological parameter comprises the concentration of a solute within a body fluid.

22. A method as in claim 21, wherein the solute is selected from the group consisting of glucose, bilirubin, creatinine, blood urea nitrogen, urinary nitrogen, renin, and angiotensin.

23. A method as in claim 10, further comprising the step of using a computer and a computer software program to analyze physiological parameter data obtained over a period of time.

24. A method as in claim 23, wherein the pin used for attaching said monitor to the lumen wall is made at least partially of dissolvable materials.

25. A method of attaching a device to a surface of an esophagus, comprising:

providing a device having a housing, a concavity on the housing, and a securing structure that is axially movable from a retracted position within the housing to an extended position which extends at least part way across the concavity;

carrying the device on an introduction instrument into the body;

positioning the device at an attachment site in the esophagus such that the concavity is adjacent the surface at the attachment site;

drawing tissue into the concavity;

advancing the securing structure into the submucosa of the esophagus, without penetrating the muscular wall of the esophagus, to retain the device at the attachment site; and

withdrawing the introduction instrument from the body, leaving the securing structure at the attachment site.

26. The method of claim 25, wherein the securing structure comprises a pin.