Implantable device and method for monitoring venous diameter

• US 8,814,798 B2
• Filed: 04/25/2008
• Issued: 08/26/2014
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Corbucci, Giorgio, Smit, Josephus P. A., Van Der Veen, Johannes S., Van Lembergen, Geert, Verschelling, Marinus C. J.
• Primary Examiner(s): Haq, Shafiqul
• Application Number:
  US12/109,408
• Publication Number:
  US 20090270729A1
• Time in Patent Office: 2,314 Days
• Field of Search: None
• US Class Current: 600/438
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

An implantable medical device system and associated method receive a signal from an implantable sensor operatively positioned relative to a vein, the signal being responsive to changes in a diameter of the vein. A diameter of the vein is determined in response to the sensor signal and used in estimating central venous pressure (CVP).

Claims

1. An implantable medical device system, comprising:

an implantable sensor comprising at least a pair of measurement electrodes, the implantable sensor configured to be operatively positioned within a vein and further configured to generate a sensor signal responsive to changes in a diameter of the vein, wherein the sensor signal comprises a signal measurable between the pair of measurement electrodes;

timing and control circuitry configured to deliver a driver signal to the sensor to enable the sensor to generate the sensor signal; and

a processor configured to receive the sensor signal, and configured to determine a diameter of the vein in response to the sensor signal and to estimate a central venous pressure (CVP) based upon the vein diameter.

2. The system of claim 1 further comprising an elongated lead body carrying the sensor, the lead body comprises a preformed portion for positioning the sensor relative to a vein wall within the vein, wherein the preformed portion comprises a preformed shape such that after any shape changing forces acting on the preformed portion are removed the preformed portion will move toward regaining its preformed shape, the sensor being positioned along the preformed portion.

3. The system of claim 2 wherein the preformed portion having a high compliance and low stiffness relative to the vein wall such that the preformed portion when in contact with a vein wall of the vein will change shape with a change in vein diameter without causing distension of the vein.

4. The system of claim 2 wherein the preformed portion comprises a bifurcation and a branch extending from the bifurcation away from the elongated lead body, wherein the branch extending from the bifurcation comprises at least one electrode and further wherein the elongate lead body comprises at least one electrode of the measurement electrode pair.

5. The system of claim 2 wherein the sensor signal comprises a signal measurable between at least a pair of measurement electrodes of the sensor representative of impedance between the measurement electrode pair, the impedance being representative of vein diameter.

6. The system of claim 1 wherein the sensor comprises an ultrasound transducer and the signal comprises an ultrasound signal.

7. The system of claim 3 wherein the sensor comprises a first electrode, a second electrode and a third electrode positioned along the preformed portion in a triangular relationship to each other;

wherein the driver signal comprises a voltage signal applied between the first electrode and the second electrode of a driver electrode pair;

wherein the sensor signal is a voltage signal measured between the second electrode and the third electrode of the measurement electrode pair;

wherein the processor is configured to compute the vein diameter in response to the measured voltage; and

wherein a distance between one of the driver electrode pair and the measurement electrode pair changes in response to a change in shape of the preformed portion resulting from a change in vein diameter.

8. The system of claim 1 wherein the processor determining the vein diameter determines a change in vein diameter corresponding to a respiratory cycle.

9. The system of claim 8 further comprising a respiration sensor generating a signal responsive to respiration, the processor further being configured to detect the respiratory cycle.

10. The system of claim 8 wherein the processor detects congestive heart failure in response to a change in vein diameter corresponding to the respiratory cycle being absent.

11. The system of claim 8 wherein estimating the central venous pressure comprises determining a trend in the change in vein diameter corresponding to a respiratory cycle.

12. The system of claim 11 wherein the processor being further configured to determine a respiration rate and wherein the trend in the change in vein diameter corresponding to a respiratory cycle compares the respiration rate to the change in vein diameter.

13. The system of claim 1 wherein the processor being further configured to determine a trend in the estimated CVP.

14. The system of claim 13 wherein the processor being further configured to detect a worsening heart failure condition in response to the estimated central venous pressure and the trend in the estimated CVP.

15. An implantable medical device system for monitoring central venous pressure (CVP), comprising:

a transvenous lead comprising a preformed portion having a high compliance and low stiffness relative to a vein in which the transvenous lead is positioned such that the preformed portion when in contact with a vein wall of the vein will change shape with a change in vein diameter without causing distension of the vein, wherein the preformed portion comprises a preformed shape such that after any shape changing forces acting on the preformed portion are removed the preformed portion will move toward regaining its preformed shape, the preformed portion changing shape in response to a physiological change in the diameter of the vein wall;

a first electrode, a second electrode and a third electrode carried by the transvenous lead and positioned along the preformed portion in a triangular relationship;

timing and control circuitry configured to deliver a driver signal between a driver electrode pair comprising the first electrode and the second electrode;

a processor configured to measure a response signal between a measurement electrode pair comprising the second electrode and the third electrode, to compute a diameter of the vein in response to the measured response signal, to estimate CVP in response to the computed vein diameter, and to detect a heart failure condition in response to the estimated CVP, wherein a shape in change of the preformed portion changes a distance between at least one of the driver electrode pair and measurement electrode pair, and wherein the processor being further configured to determine a change in the computed vein diameter due to a respiration cycle and to determine a trend in the change in vein diameter due to respiration.