Vascular pressure sensor with electrocardiogram electrodes

• US 8,784,310 B2
• Filed: 05/24/2010
• Issued: 07/22/2014
• Est. Priority Date: 07/02/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E., Piaget, Thomas W.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US12/786,159
• Publication Number:
  US 20110004075A1
• Time in Patent Office: 1,520 Days
• Field of Search: 600/485, 600/486, 607/40, 607/9
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive

Abstract

Devices, systems, and methods for sensing cardiac electrical activity and blood pressure within a blood vessel are disclosed. A vascular sensor includes a fixation element configured to secure the vascular sensor within a blood vessel, a sensor module housing coupled to the fixation element, a pressure sensor disposed within an interior portion of the housing and configured to sense blood pressure within the vessel, and a number of electrocardiogram sensing electrodes exposed to tissue and blood within the blood vessel and configured to sense cardiac electrical data within the blood vessel. A controller module processes the sensed cardiac electrical data and blood pressure data and stores the data within a memory unit and/or transmits the data to a communicating device in wireless communication with the vascular sensor.

Claims

1. A leadless implantable vascular sensor, comprising:

at least one fixation element configured to secure the vascular sensor within a blood vessel;

a sensor module housing coupled to the fixation element and including;

a sensor housing including a plurality of exterior surfaces defining an interior portion of the sensor housing;

a power supply housing coupled to the sensor housing and containing an energy storage device;

a pressure sensor disposed within the interior portion of the sensor housing, the pressure sensor configured to sense blood pressure data within the blood vessel;

a first electrocardiogram sensing electrode disposed on an exterior portion of the sensor housing;

a second electrocardiogram sensing electrode disposed on an exterior portion of the power supply housing;

an insulative break disposed on at least a portion of at least one of the plurality of exterior surfaces of the sensor housing and electrically isolating the first electrocardiogram sensing electrode from the second electrocardiogram sensing electrode,

the sensor module housing further comprising a pair of parallel and opposed ends, the pair of parallel and opposed ends comprising a first end disposed on the sensor housing and a second end disposed on the power supply housing, and a plurality of sides disposed between the first end and the second end and including the plurality of exterior surfaces of the sensor housing, wherein;

the first electrocardiogram sensing electrode is disposed on the first end; and

the second electrocardiogram sensing electrode is disposed on the second end;

the first and second electrocardiogram sensing electrodes configured to sense cardiac electrical data within the blood vessel; and

circuitry means for processing the cardiac electrical data and blood pressure data sensed by the electrocardiogram sensing electrodes and pressure sensor to correlate the timing of the blood pressure data with a timing of a cardiac cycle.

2. The vascular sensor of claim 1, wherein:

the first electrocardiogram sensing electrode is electrically connected to the at least one fixation element; and

the second electrocardiogram sensing electrode is coupled to the sensor housing.

3. The vascular sensor of claim 2, further comprising:

a tether wire extending proximally from the at least one fixation element; and

a conductive ring disposed at a proximal end of the tether wire, wherein the conductive ring is coupled to the power supply housing, thereby electrically coupling the first electrocardiogram sensing electrode to the at least one fixation element.

4. The vascular sensor of claim 1, wherein the at least one fixation element includes a first fixation element and a second fixation element, the first fixation element electrically coupled to the first electrocardiogram sensing electrode, the second fixation element electrically coupled to the second electrocardiogram sensing electrode.

5. The vascular sensor of claim 1, further including a communication module configured to wirelessly transmit sensed cardiac electrical data and blood pressure data to a communicating device.

6. The vascular sensor of claim 1, wherein the first and second electrocardiogram sensing electrodes are conductive-type electrodes.

7. The vascular sensor of claim 1, wherein the first and second electrocardiogram sensing electrodes are capacitive-type electrodes.

8. The vascular sensor of claim 1, wherein the circuitry means includes a controller module configured to:

generate an electrocardiogram waveform from cardiac electrical data sensed by the electrocardiogram sensing electrodes; and

generate a pressure waveform from blood pressure data sensed by the pressure sensor.

9. The vascular sensor of claim 8, wherein the controller module is configured to associate the electrocardiogram waveform with the pressure waveform to detect an event or condition within the body.

10. The vascular sensor of claim 1, further comprising a sensor coupled to the circuitry means, the sensor being configured to sense at least one of position, blood flow, posture, radiation level, and glucose level.

11. A system for sensing cardiac electrical activity and blood pressure within a blood vessel, the system comprising:

a leadless implantable vascular sensor, comprising;

an expandable fixation element;

a sensor module housing coupled to the expandable fixation element and including;

a sensor housing including a plurality of exterior surfaces defining an interior portion of the sensor housing;

a power supply housing coupled to the sensor housing and containing an energy storage device;

a pressure sensor disposed within the interior portion of the sensor housing, the pressure sensor configured to sense blood pressure within the blood vessel;

a first electrocardiogram sensing electrode disposed on an exterior portion of the sensor housing;

a second electrocardiogram sensing electrode disposed on an exterior portion of the power supply housing;

an insulative break disposed on at least a portion of at least one of the plurality of exterior surfaces of the sensor housing and electrically isolating the first electrocardiogram sensing electrode from the second electrocardiogram sensing electrode;

the sensor module housing further comprising a pair of parallel and opposed ends, the pair of parallel and opposed ends comprising a first end disposed on the sensor housing and a second end disposed on the power supply housing, and a plurality of sides disposed between the first end and the second end and including the plurality of exterior surfaces of the sensor housing, wherein;

the first electrocardiogram sensing electrode is disposed on the first end; and

the second electrocardiogram sensing electrode is disposed on the second end;

wherein the first and second electrocardiogram sensing electrodes are exposed to tissue within the blood vessel and configured to sense cardiac electrical data within the blood vessel;

circuitry for processing cardiac electrical data and blood pressure data sensed by the electrocardiogram sensing electrodes and pressure sensor; and

a communication module configured to wirelessly transmit sensed cardiac electrical data and blood pressure data; and

a communicating device configured to wirelessly receive the sensed cardiac electrical data and blood pressure data from the vascular sensor.

12. The system of claim 11, wherein the communication module includes an ultrasonic transducer, and wherein the ultrasonic transducer is configured to acoustically transmit sensed cardiac electrical data and blood pressure data to the communicating device.

13. The system of claim 11, wherein at least one of the vascular sensor and communicating device is configured to:

generate an electrocardiogram waveform from the cardiac electrical sensed by the electrocardiogram sensing electrodes; and

generate a pressure waveform from the blood pressure data sensed by the pressure sensor.

14. The system of claim 13, wherein the communicating device comprises an external monitor configured to display the electrocardiogram waveform and the pressure waveform.

15. A method of sensing cardiac electrical activity and blood pressure within a blood vessel, comprising:

implanting a leadless vascular sensor within a blood vessel of a patient, the vascular sensor including;

a vascular sensor housing including;

a sensor housing including a plurality of exterior surfaces defining an interior portion of the sensor housing;

a power supply housing coupled to the sensor housing and containing an energy storage device;

a pressure sensor disposed within the interior portion of the sensor housing;

a first electrocardiogram sensing electrode disposed on an exterior portion of the sensor housing and exposed to tissue within the blood vessel;

a second electrocardiogram sensing electrode disposed on an exterior portion of the power supply housing and exposed to tissue within the blood vessel; and

an insulative break disposed on at least a portion of at least one of the plurality of exterior surfaces of the sensor housing and electrically isolating the first electrocardiogram sensing electrode from the second electrocardiogram sensing electrode;

the sensor module housing further comprising a pair of parallel and opposed ends, the pair of parallel and opposed ends comprising a first end disposed on the sensor housing and a second end disposed on the power supply housing, and a plurality of sides disposed between the first end and the second end and including the plurality of exterior surfaces of the sensor housing, wherein;

the first electrocardiogram sensing electrode is disposed on the first end; and

the second electrocardiogram sensing electrode is disposed on the second end;

sensing blood pressure data within the blood vessel using the pressure sensor;

sensing cardiac electrical data within the blood vessel using the first and second electrocardiogram sensing electrodes;

wirelessly transmitting sensed blood pressure data and cardiac electrical data to a device in wireless communication with the vascular sensor; and

analyzing the sensed blood pressure data and cardiac electrical data, wherein analyzing the sensed blood pressure data and cardiac electrical data includes;

generating a pressure waveform from the sensed blood pressure data;

generating an electrocardiogram waveform from the sensed cardiac electrical data; and

correlating the timing of one or more events in the blood pressure waveform with electrocardiogram waveform to detect an event or condition within the body.