Intracardiac pressure monitoring method

• US 6,652,464 B2
• Filed: 12/18/2000
• Issued: 11/25/2003
• Est. Priority Date: 12/18/2000
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Govari, Assaf, Ben-Haim, Shlomo, Schwartz, Yitzhack, Zilberstein, Joel, Capezzuto, Louis J.
• Primary Examiner(s): Tyler, Cheryl J.
• Assistant Examiner(s): Belena, John F
• Application Number:
  US09/739,062
• Publication Number:
  US 20020077554A1
• Time in Patent Office: 1,072 Days
• Field of Search: 600/437, 600/443, 600/485, 600/486, 600/488, 600/587, 128/903
• US Class Current: 600/486
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A method for telemetrically measuring a parameter in a patient'"'"'s heart comprises the steps of imaging the heart and identifying an implantation site in the heart. An opening is created in the tissue at the implantation site. A sensor comprising a housing, a membrane at one end of the housing wherein the membrane is deformable in response to the parameter, and a microchip positioned within the housing and operatively communicating with the membrane for transmitting a signal indicative of the parameter is provided. The sensor is placed in the opening and the parameter is telemetrically measured from outside of the patient'"'"'s body based on the transmitted signal by the sensor. The sensor is also telemetrically powered from outside of the patient'"'"'s body. A signal charging and reading device is placed outside of the patient'"'"'s body for telemetric powering and signal reading with respect to the sensor. In an alternative embodiment, the sensor has a tapered distal end and a tissue piercing tip for direct implantation into tissue. Alternative embodiments of this sensor include helical threads on the tapered distal end for threading the sensor into tissue and a plurality of tissue barbs for direct and firm anchoring of the sensor in tissue.

Claims

1. A method for telemetrically measuring a parameter in a patient'"'"'s heart, the method comprising the steps of:

imaging the heart;

identifying an implantation site in the heart;

creating an opening in a tissue at the implantation site;

providing a sensor comprising a housing, a membrane at one end of the housing, the membrane being defonnable in response to the parameter, and a microchip positioned within the housing and operatively communicating with the membrane for transmitting a signal indicative of the parameter, the microchip having an array of photoelectric cells, and a light emitting diode operatively connected to the microchip and spaced away from the array of photoelectric cells, and a shutter fixed to the membrane and movably extendable over the array of photoelectric cells, the shutter being movable in association with the membrane;

placing the sensor in the opening; and

telemetrically measuring the parameter from outside of the patient'"'"'s body based on the transmitted signal emitted by the sensor.

2. The method according the claim 1, including telemetrically powering the sensor from outside of the patient'"'"'s body.

3. The method according to claim 2, including displaying the measured parameter.

4. The method according to claim 3, including measuring the parameter, powering the sensor, and displaying the measured parameter with a signal reading and charging device.

5. The method according to claim 4, including taking parameter measurements multiple times per second with the signal reading and charging device.

6. The method according to claim 5, wherein the sensor is positioned within a chamber of the heart.

7. The method according to claim 6, wherein the implantation site is a septum.

8. The method according to claim 7, wherein the implantation site further includes a fossa ovalis.

9. The method according to claim 8, wherein the parameter is a hemodynamic blood pressure.

10. The method according to claim 5, including taking in the range of 10-20 parameter measurements per second.

11. The method according to claim 1, including creating the opening with a needle.

12. The method according to claim 11, including providing a plurality of anchoring legs on the sensor and anchoring the sensor to the tissue.

13. The method according to claim 12, including preventing thrombosis within the heart by coating the sensor with a nonthrombogenic agent.

14. The method according to claim 1, wherein the imaging is conducted using transesophageal ultrasonic imaging.

15. A method for telemetrically measuring a parameter in a patient'"'"'s heart, the method comprising the steps of:

imaging the heart;

identifying an implantation site in the heart;

providing a sensor comprising a housing, a membrane at one end of the housing, the membrane being deformable in response to the parameter, and a microchip positioned within the housing and operatively communicating with the membrane for transmitting a signal indicative of the parameter, the microchip having an array of photoelectric cells, and a light emitting diode operatively connected to the microchip and spaced away from the array of photoelectric cells, and a shutter fixed to the membrane and movably extendable over the array of photoelectric cells, the shutter being movable in association with the membrane;

implanting the sensor at the site with a piercing tip and a tapped distal end of the sensor;

telemetrically measuring the parameter from outside of the patient'"'"'s body based on the transmission signal emitted by the sensor.

16. The method according to claim 15, including telemetrically powering the sensor from outside of the patient'"'"'s body.

17. The method according to claim 16, including displaying the measured parameter.

18. The method according to claim 17, including measuring the parameter, powering the sensor, and displaying the measured parameter with a signal reading and charging device.

19. The method according to claim 18, including taking parameter measurements multiple times per second with the signal reading and charging device.

20. The method according to claim 19, wherein the sensor is positioned within a chamber of the heart.

21. The method according to claim 20, wherein the implantation site is a septum.

22. The method according to claim 21, wherein the implantation site further includes a fossa ovalis.

23. The method according to claim 22, wherein the parameter is a hemodynamic blood pressure.

24. The method according to claim 23, including taking in the range of 10-20 parameter measurements per second.

25. The method according to claim 16, including preventing thrombosis within the heart by coating the sensor with a nonthrombogenic agent.

26. The method according to claim 16, including providing helical threads on the tapered distal end of the sensor and anchoring the sensor into a tissue at the implantation site by threading the tapered distal end into the tissue.

27. The method according to claim 16, including providing a plurality of tissue barbs on the tapered distal end of the sensor and anchoring the tapered distal end of the sensor into a tissue at the implantation site with the tissue barbs.

28. The method according to claim 15, wherein the imaging is conducted using transesophageal ultrasonic imaging.

29. A method for telemetrically measuring a parameter in a patient'"'"'s heart, the method comprising the steps of:

imaging the heart;

identifying an implantation site in the heart;

providing a sensor comprising a housing having a tapered distal end and piercing tip thereon, the tapered distal end having helical threads, a membrane at one end of the housing, the membrane being deformable in response to the parameter, and a microchip positioned within the housing and operatively communicating with the membrane for transmitting a signal indicative of the parameter;

implanting the sensor at the site with the piercing tip and the tapered distal end of the sensor by threading the tapered distal end into tissue at the site;

telemetrically powering the sensor from outside of the patient'"'"'s body and telemetrically measuring the parameter from outside of the patient'"'"'s body based on the transmission signal by the sensor.

30. The method according to claim 29, including displaying the measured parameter.

31. The method according to claim 30, including measuring the parameter, powering the sensor, and displaying the measured parameter with a signal reading and charging device.

32. The method according to claim 31, including taking parameter measurements multiple times per second with the signal reading and charging device.

33. The method according to claim 32, wherein the sensor is positioned within a chamber of the heart.

34. The method according to claim 33, wherein the implantation site is the septum.

35. The method according to claim 34, wherein the implantation site further includes the fossa ovalis.

36. The method according to claim 35, wherein the parameter is hemodynamic blood pressure.

37. The method according to claim 36, including taking between 10-20 parameter measurements per second.

38. The method according to claim 29, including preventing thrombosis within the heart by coating the sensor with a nonthrombogenic agent.

39. The method according to claim 29, including providing a plurality of tissue barbs on the tapered distal end of the sensor and anchoring the tapered distal end of the sensor into the tissue at the site with the tissue barbs.

40. The method according to claim 29, wherein the imaging is conducted using transesophageal ultrasonic imaging.