Device for determining the flow rate of a blood flow, and cardiovascular assist device

• US 8,721,558 B2
• Filed: 07/24/2009
• Issued: 05/13/2014
• Est. Priority Date: 07/28/2008
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Kolberg, Gernot, Bartels, Klaus
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US12/508,706
• Publication Number:
  US 20100022899A1
• Time in Patent Office: 1,754 Days
• Field of Search: 600/505, 600/506, 600/504, 600/16, 600/17, 607/17
• US Class Current: 600/505
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6886 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61N 1/36571 controlled by blood flow rate, e.g. blood velocity or cardiac output

Abstract

A device for the in vivo determination of the blood flow rate in a patient'"'"'s blood vessel includes a microelectrode arrangement provided for placement in the blood vessel, an electrical power source which provides excitation energy having physiologically harmless parameters for obtaining a measured signal, a signal detector for detecting an electrical measured signal resulting from the blood flow in the presence of the excitation energy at measuring electrodes of the microelectrode arrangement, and a signal evaluation device, connected to the signal detector, for determining the blood flow rate on the basis of the measured signal.

Claims

1. An implantable cardiovascular assist device providing in vivo determination of the blood flow rate in a bloodstream of a patient, the device including:

a. an elongated electrode line including one or more stimulation electrodes for delivering stimulation pulses to a heart,

b. multiple sets of microelectrodes configured for placement in the bloodstream,

(1) the sets of microelectrodes being positioned spaced apart on the surface of the electrode line separate and spaced from the one or more stimulation electrodes,

(2) each set of microelectrodes including at least one excitation electrode and at least one measuring electrode, each excitation electrode being spaced from one or more of the measuring electrodes by an elongated gap which is narrower than the electrode lengths of the spaced excitation and measuring electrodes, with the gap and the electrode lengths being measured along an axis bisecting the electrodes,

c. an electrical power source connected to the excitation electrodes, the power source being configured to provide excitation energy,

d. a signal detector wherein;

(1) each set of microelectrodes is independently connected to the signal detector, whereby each set delivers independently obtained measured signals to the signal detector, and

(2) in the presence of the excitation energy, the signal detector detects an electrical measured signal at the measuring electrodes resulting from the blood flow, and

e. a signal evaluation device in communication with the signal detector, the signal evaluation device being configured to determine the blood flow rate on the basis of the measured signal.

2. The device of claim 1 wherein:

a. the microelectrodes include at least two measuring electrodes,

b. the power source includes an alternating voltage source wherein alternating voltage is provided as excitation energy to the excitation electrodes, and

c. the signal detector performs time-dependent measurement of a complex impedance between two or more measuring electrodes.

3. The device of claim 1 wherein the power source includes a pulse generator for generating an excitation pulse sequence, wherein the excitation pulse sequence is provided as excitation energy to the excitation electrodes.

4. The device of claim 1 wherein at least one of the electrodes is switchable to alternate between service as a measuring electrode and an excitation electrode.

5. The device of claim 1 wherein at least one of the excitation electrode and the measuring electrode:

a. is bounded by a perimeter, wherein the electrode has a geometric electrode area defined within the perimeter; and

b. has a surface area configured to be in contact with the blood flow wherein the surface area is at least twice as large as the geometric electrode area.

6. The device of claim 1 wherein the microelectrodes collectively have a surface area between 300 and 2000 square micrometers.

7. The device of claim 1 wherein:

a. the microelectrodes include at least two measuring electrodes,

b. each measuring electrode is spaced from all other measuring electrodes by at least three times the largest dimension of the measuring electrode, as measured from one side of the measuring electrode'"'"'s perimeter to the opposing side of the measuring electrode'"'"'s perimeter.

8. The device of claim 1 wherein the power source and the signal detector are situated in a housing of the implantable cardiovascular assist device.

9. The device of claim 1 further including a selection circuit selectively:

a. enabling one or more of the sets of microelectrodes, and

b. disabling one or more of the sets of microelectrodes wherein the signals obtained therefrom are indicative of overgrowth of one or more of the electrodes therein.

10. The device of claim 1 wherein the microelectrodes:

a. include at least two excitation electrodes, and

b. are arrayed with each pair of excitation electrodes spaced along the length of the electrode line with a single measuring electrode situated therebetween.

11. The device of claim 1 wherein the excitation electrodes and the measuring electrodes have spiral shapes.

12. The device of claim 1 wherein the excitation electrodes and the measuring electrodes are spaced by a narrow annular gap.

13. The device of claim 1 wherein the excitation electrodes and the measuring electrodes are defined by intermeshing teeth.

14. The device of claim 1 further including one or more spacers situated adjacent the microelectrodes and extending outwardly therefrom, whereby the one or more spacers maintain the microelectrodes at a distance from a wall of a blood vessel when the microelectrodes are inserted into the blood vessel.

15. The device of claim 14 wherein the spacers are aligned at an acute angle relative to a longitudinal axis of the electrode line.

16. The device of claim 14 wherein the spacers are elastically biased away from the electrode line.

17. The device of claim 1 wherein the cardiovascular assist device is a cardiac pacemaker and/or a defibrillator configured to deliver stimulation to a heart at least partially in response to the blood flow rate determined by the signal evaluation device.

25. The device of claim 1 wherein the power source is configured to provide excitation energy to both the excitation electrodes and the measuring electrodes.

26. The device of claim 1 wherein:

a. the excitation energy is defined by time-varying voltage, and

b. the electrical measured signal is defined by a complex impedance.

18. A cardiac pacemaker and/or defibrillator including:

a. an elongated electrode line having a line surface bearing;

(1) one or more stimulation electrodes for delivering stimulation pulses to a heart,

(2) one or more excitation electrodes, each excitation electrode being a microelectrode;

i. spaced from each stimulation electrode, and

ii. in communication with an electrical power source configured to provide excitation energy to the excitation electrode,

(3) one or more measuring electrodes, each measuring electrode being a microelectrode;

i. spaced from each stimulation electrode,

ii. spaced from each excitation electrode by a gap which is narrower than the electrode lengths of the spaced measuring and excitation electrodes, with the gap and electrode lengths being measured along an axis bisecting the measuring and excitation electrodes, and

iii. in communication with a signal detector, wherein in the presence of the excitation energy, the signal detector detects an electrical measured signal at the measuring electrode resulting from any blood flow adjacent the measuring electrode, and

(4) spacers extending outwardly from the line surface, whereby the spacers space the line surface at a distance from a wall of a blood vessel when the electrode line is inserted into the blood vessel;

b. a signal evaluation device in communication with the signal detector, the signal evaluation device being configured to determine the blood flow rate adjacent one or more of the measuring electrodes on the basis of the measured signal.

19. The device of claim 18 wherein the excitation electrodes and the measuring electrodes have spiral shapes.

20. The device of claim 18 wherein:

a. the microelectrodes include at least two measuring electrodes,

b. the power source includes an alternating voltage source wherein alternating voltage is provided as excitation energy to the excitation electrodes, and

c. the signal detector performs time-dependent measurement of a complex impedance between two or more measuring electrodes.

21. The device of claim 18 wherein at least one of the electrodes is switchable to alternate between service as a measuring electrode and an excitation electrode.

22. The device of claim 18 wherein:

a. the microelectrodes include at least two measuring electrodes,

b. each measuring electrode is spaced from all other measuring electrodes by at least three times the largest dimension of the measuring electrode, as measured from one side of the measuring electrode'"'"'s perimeter to the opposing side of the measuring electrode'"'"'s perimeter.

23. The device of claim 18 further including a selection circuit selectively:

a. enabling one or more of the sets of microelectrodes, and

b. disabling one or more of the sets of microelectrodes wherein the signals obtained therefrom are indicative of overgrowth of one or more of the electrodes therein.

24. The device of claim 18 wherein the microelectrodes:

a. include at least two excitation electrodes, and

b. are arrayed with each pair of excitation electrodes spaced along the length of the electrode line with a single measuring electrode situated therebetween.